DUAL REGION ACCOMMODATING INTRAOCULAR LENS DEVICES, SYSTEMS, AND METHODS
20170348091 · 2017-12-07
Inventors
- JOHN A. CAMPIN (SOUTHLAKE, TX, US)
- COSTIN E. CURATU (CROWLEY, TX, US)
- ERDEM ERDEN (FORT WORTH, TX, US)
- GEORGE H. PETTIT (FORT WORTH, TX, US)
Cpc classification
A61F2/1659
HUMAN NECESSITIES
A61F2/161
HUMAN NECESSITIES
A61F2/1627
HUMAN NECESSITIES
A61F2002/1696
HUMAN NECESSITIES
International classification
Abstract
Disclosed herein is an implantable accommodative IOL device for insertion into an eye of a patient, comprising an active region and a passive region. The active region has a first thickness and first refractive index, and the active region comprises an electrically responsive optical lens having variable optical power. The passive region is disposed at a periphery of the active region, and the passive region has a second thickness and a second refractive index. The second refractive index is different than the first refractive index. Thus, the light beams passing through the active and passive regions have a phase difference, thereby providing an extended depth of field.
Claims
1. An implantable accommodative IOL device for insertion into an eye of a patient, the device comprising: an active region having a first thickness and a first refractive index, the active region comprising an electrically responsive optical lens having variable optical power; and a passive region disposed at a periphery of the active region, the passive region having a second thickness and a second refractive index, the second refractive index being different than the first refractive index, wherein a light beam passing through the active region has a phase difference from the light beam passing through the passive region.
2. The accommodative IOL device of claim 1, wherein the phase difference provides the implantable accommodative IOL device with an extended depth of field.
3. The accommodative IOL device of claim 1, wherein the active region comprises a circular disc.
4. The accommodative IOL device of claim 3, wherein the passive region comprises an annular ring disposed circumferentially around the active region.
5. The accommodative IOL device of claim 1, wherein the first thickness is different than the second thickness.
6. The accommodative IOL device of claim 1, wherein the first thickness tapers from a central area to a peripheral area of the active region.
7. The accommodative IOL device of claim 1, wherein the second thickness tapers from a central area to a peripheral area of the passive region.
8. The accommodative IOL device of claim 1, wherein the active region and the passive region have the same optical power when accommodative IOL device is in an unpowered state.
9. The accommodative IOL device of claim 8, wherein the phase difference results from the difference between the first refractive index and the second refractive index.
10. The accommodative IOL device of claim 1, wherein the active region and the passive region have matching focal points.
11. The accommodative IOL device of claim 1, wherein a peripheral edge of the passive region is configured to contact the lens capsule.
12. The accommodative IOL device of claim 1, wherein a peripheral edge of the passive region is configured to reside in the eye sulcus.
13. The accommodative IOL device of claim 1, wherein the passive region includes an external diameter sized to match an internal diameter of an equatorial region of the lens capsule in the eye.
14. The accommodative IOL device of claim 1, further comprising a housing configured to hold electrical connections connected to the active region.
15. The accommodative IOL device of claim 1, wherein the active region comprises tunable optics technology.
16. An implantable accommodative IOL device for insertion into an eye of a patient, the device comprising: an active region shaped as a disc having a first thickness and first refractive index, the active region comprising an electrically tunable lens having variable optical power; and a passive region shaped as an annular ring disposed circumferentially around the active region, the passive region having a second thickness and a second refractive index, the second thickness being different than the first thickness, wherein light beams passing through the active and passive regions have a phase difference.
17. The accommodative IOL device of claim 16, wherein the phase difference provides the implantable IOL device with an extended depth of field.
18. The accommodative IOL device of claim 16, wherein the first refractive index is different than the second refractive index.
19. The accommodative IOL device of claim 16, wherein the second thickness tapers from a central area to a peripheral area of the passive region.
20. The accommodative IOL device of claim 16, wherein the active region and the passive region have the same optical power when accommodative IOL device is in an unpowered state.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] The accompanying drawings illustrate embodiments of the devices and methods disclosed herein and together with the description, serve to explain the principles of the present disclosure.
[0021]
[0022]
[0023]
[0024]
[0025]
[0026]
[0027]
[0028]
[0029]
DETAILED DESCRIPTION
[0030] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is intended. Any alterations and further modifications to the described devices, instruments, methods, and any further application of the principles of the present disclosure are fully contemplated as would normally occur to one skilled in the art to which the disclosure relates. In particular, it is fully contemplated that the features, components, and/or steps described with respect to one embodiment may be combined with the features, components, and/or steps described with respect to other embodiments of the present disclosure. For the sake of brevity, however, the numerous iterations of these combinations will not be described separately. For simplicity, in some instances the same reference numbers are used throughout the drawings to refer to the same or like parts.
[0031] The present disclosure relates generally to devices, systems, and methods for use in alleviating ophthalmic conditions, including visual impairment secondary to presbyopia, cataracts, and/or macular degeneration. As described above, electrically actuated accommodative intraocular lens (“IOL”) devices have the risk of becoming nonoperational or providing poor visual quality in the case of a power or system failure. Embodiments of the present disclosure comprise accommodating IOL devices configured to correct for far- and/or near-sighted vision and to provide good image quality and extended depth of field (“EDOF”) capabilities even in cases of system failure. In some embodiments, the accommodative IOL devices described herein provide good visual quality by maintaining monofocal vision quality and providing extended depth of field even in an unpowered situation. The accommodative IOL devices described herein are configured to provide clear corrective vision and high image quality to patients having various visual deficits and various pupil sizes.
[0032] In some embodiments, the accommodating IOL devices described herein include an electro-active optical component and a passive optical component that are separable and distinct parts of the device. Such embodiments may facilitate implantation through a smaller incision than a conventional monolithic electro-active accommodative implant. In some instances, the accommodating IOL devices described herein can be implanted in the eye to replace a diseased lens (e.g., an opacified natural lens of a cataract patient). In other instances, the accommodating IOL devices described herein may be implanted in the eye sulcus 32 (shown in
[0033]
[0034] A common technique of cataract surgery is extracapsular cataract extraction (“ECCE”), which involves the creation of an incision near the outer edge of the cornea 14 and an opening in the anterior capsule 20 (i.e., an anterior capsulotomy) through which the opacified lens 12 is removed. The lens 12 can be removed by various known methods including phacoemulsification, in which ultrasonic energy is applied to the lens to break it into small pieces that are promptly aspirated from the lens capsule 18. Thus, with the exception of the portion of the anterior capsule 20 that is removed in order to gain access to the lens 12, the lens capsule 18 remains substantially intact throughout an ECCE. The intact posterior capsule 22 provides a support for the IOL and acts as a barrier to the vitreous humor within the vitreous chamber. Following removal of the opacified lens 12, an IOL may be implanted within the lens capsule 18, through the opening in the anterior capsule 20, to restore the transparency and refractive function of a healthy lens. The IOL may be acted on by the zonular forces exerted by a ciliary body 28 and attached zonules 30 surrounding the periphery of the lens capsule 18. The ciliary body 28 and the zonules 30 anchor the lens capsule 18 in place and facilitate accommodation, the process by which the eye 10 changes optical power to maintain a clear focus on an image as its distance varies.
[0035]
[0036] In the pictured embodiment, the active region 105 occupies a central position of the disc, and the passive region 110 occupies a peripheral region of the disc. The active region 105 is shaped and configured as a generally circular area. In other embodiments, the active region 105 may have any of a variety of shapes, including for example rectangular, ovoid, oblong, and square. In some embodiments, the active region 105 includes a refractive index that is different than the refractive index of the passive region 110. The active region 105 includes a thickness T1 that may range from 0.2 mm to 2 mm. For example, in one exemplary embodiment, the thickness T1 of the active region 105 may be 0.6 mm. In some embodiments, the thickness T1 of the active region 105 varies from the center of the active region 105 to the periphery of the active region 105. For example, in some embodiments, the active region 105 may taper in thickness from its center to its periphery.
[0037] The electro-active or active region 105 may comprise any of a variety of materials having optical properties that may be altered by electrical control. The active region 105 comprises an electro-active element that can provide variable optical power via any available tunable optics technology including, by way of non-limiting example, moving lenses, liquid crystals, and/or electro-wetting. Although the alterable properties described herein typically include refractive index and optical power, embodiments of the invention may include materials having other alterable properties, such as for example, prismatic power, tinting, and opacity. The properties of the materials may be affected and controlled electrically, physically (e.g., through motion), and/or optically (e.g., through light changes). The active region 105 has an adjustable optical power based on electrical input signals controlling the region, so that the power of the accommodative IOL device 100 can be adjusted based on the patient's sensed or inputted accommodation demand. The accommodative IOL device 100 may include control circuitry, power supplies, and wireless communication capabilities. In some embodiments, this componentry may be packaged in a biocompatible material and/or sealed electronic packaging.
[0038] The passive region 110 is shaped and configured as an annular ring encircling the active region 105. The passive region 110 includes a refractive index that is different than the refractive index of the active region 105. In some embodiments, the passive region 110 includes a thickness T2 that is different than the thickness T1 of the active region. The thickness T2 may range from 0.2 mm to 2 mm. For example, in one exemplary embodiment, the thickness T2 of the passive region 110 may be 0.6 mm. In some embodiments, as shown in
[0039] Although an outer diameter D1 of the active region 105 is shown as substantially smaller than an outer diameter D2 of the passive region 110 in the pictured embodiment, the outer diameter D1 of the active region 105 may be sized larger relative to an outer diameter D2 of the passive region 110 in other embodiments. For example, in other embodiments, the outer diameter D1 of the active region 105 may be almost as large as the outer diameter D2 of the passive region 110. In various embodiments, the outer diameter D1 of the active region 105 may range from 3 mm to 6 mm, and the outer diameter D2 of the passive region 110 may range from 6 mm to 12 mm. For example, in one exemplary embodiment, the outer diameter D1 of the active region 105 may be 3 mm, and the outer diameter D2 of the passive region 110 may be 6 mm.
[0040] The accommodative IOL device 100 is designed and optimized to have matching focuses (or matching focal points) for both the active region 105 and the passive region 110 to provide a focused image on the retina 11 for far objects for all pupil sizes. As the object draws closer to the eye 10, the optical power of the active region 105 may be adjusted in response to the input signal (e.g., the electrical input signal) to keep the image focused on the retina 11. This provides accommodation to the patient in a similar manner as a healthy natural crystalline lens.
[0041] In some embodiments, the active region 105 may be associated with several other components designed to power and control the active region, as shown in
where n.sub.a is the refractive index of the active region 105, n.sub.p is the refractive index of the passive region 110, n.sub.1 is the refractive index of the surrounding medium, T.sub.1 is the thickness of the active region 108, and T.sub.2 is the thickness of the passive region 110. In this manner, the trapezoidal phase shift provides different apparent depth of focus depending on pupil size, allowing the image to change as a result of changes in light conditions. This in turn provides slightly different images for conditions in which one would be more likely to be relying on near or distance vision, allowing the patient's visual function to better operate under these conditions, a phenomenon known as “pseudo-accommodation.” In particular, the waves having phase differences will interfere, thereby creating extension of the depth of field and a smooth continuity of visual extension.
[0042] Thus, the phase difference between the two regions (i.e., the active region 105 and the passive region 110) creates an extended depth of field for the patient that allows the patient to have a range of vision in a situation where the active region 105 cannot receive power or is otherwise malfunctioning. In the case of a system failure or power failure to the active region 105, the accommodative IOL device 100 will continue to have monofocal IOL performance and to provide an extended depth of field to the patient.
[0043] In some embodiments, in its expanded condition, the accommodative IOL device 100 comprises a substantially circular device, as shown in
[0044]
[0045] As shown in
[0046] As shown in
[0047]
[0048] The two-element accommodative IOL device 150 can reduce the overall incision size during implantation in the eye 10. In particular, the two-element characteristic of the accommodative IOL device 150 allows the surgeon to implant the two lenses (i.e., the active element 155 and the passive element 160) one after another. Each lens or element would have a smaller volume individually than an accommodative IOL device that included both the passive and active elements within a single, monolithic structure. Thus, the two-element accommodative IOL device 150 described herein would require a smaller incision than would a monolithic IOL device.
[0049] In the pictured embodiment shown in
[0050] By providing unique and separable active and passive optical elements 155 and 160, respectively, the accommodative IOL device 150 allows more options for customizing the combination of accommodative optical power and static optical power and for positioning the elements 155, 160 within the eye 10. In addition, the accommodative IOL device 150 introduces the possibility of implanting only one element of the active and passive elements 155, 160, respectively, into the eye 10. For example, in an instance where the patient has presbyopia without cataracts, it may be preferable to implant only the active element 155 in front of (i.e., anterior to) a non-cataractous, presbyopic crystalline lens.
[0051] In some embodiments, in its expanded condition, the accommodative IOL device 150 comprises a substantially circular device configured to be self-stabilized within the eye 10 (e.g., within the lens capsule 18 or the sulcus 32). In some embodiments, in its expanded condition, the accommodative IOL device 150 comprises a substantially circular device having haptic supports 220, as described below in relation to
[0052] The passive element 160 and/or the active element 155 may be shaped and configured to maintain the natural circular contour of the lens capsule 18 and to stabilize the lens capsule 18 in the presence of compromised zonular integrity when the accommodative IOL device 150 is positioned in the eye 10. In some embodiments, the passive element 160 comprises a generally circular disc with a substantially circular shape configured to match the substantially circular cross-sectional shape of the lens capsule 18 when the lens capsule 18 is divided on a coronal plane through an equatorial region 23. In some embodiments, the device 150 (i.e., the active element 155 and/or the passive element 160) may taper from the central region 165 of the device 150 towards a peripheral edge 170. The peripheral edge 170 comprises the outermost circumferential region of the accommodative IOL device 150. In some embodiments, the accommodative IOL device 150 may taper toward its peripheral edge 170 to facilitate stabilization of the accommodative IOL device 100 inside the lens capsule 18 and/or the eye sulcus 32. This may allow the accommodative IOL device 150 to be self-stabilized and self-retained in the eye 10 (i.e., without the use of sutures, tacks, or a manually held instrument). In some embodiments, the angle of the taper from the central region 165 towards the peripheral edge 170 is selected to substantially match the angle of the equatorial region 23 in the lens capsule 18, thereby facilitating self-stabilization of the accommodative IOL device 150 within the eye 10.
[0053]
[0054] The exemplary accommodative IOL device 200 shown in
[0055] In some instances, the two-element accommodative IOL device 200 (and the IOL device 150) can offer enhanced stability of the device and improved protection for the structures of the eye 10 in comparison to conventional IOL devices. For example, in some embodiments, as shown in
[0056] In the pictured embodiment, the accommodative IOL device 200 comprises a substantially circular device including haptic supports 220, as shown in
[0057] The accommodative IOL devices and systems described herein may be formed from any of a variety of biocompatible materials having the necessary optical properties to perform adequate vision correction as well as requisite properties of resilience, flexibility, expandability, and suitability for use in intraocular procedures. In some embodiments, the individual components of the accommodative IOL devices described herein may be formed of different biocompatible materials of varying degrees of pliancy. For example, in some embodiments, the passive region 110 and the passive elements 160 and 210 may be formed of a more flexible and pliant material than the active region 105 and the active elements 155 and 205 to minimize contact damage or trauma to intraocular structures. In other embodiments, the reverse relationship may exist. The accommodative IOL devices described herein may be coated with any of a variety of biocompatible materials, including, by way of non-limiting example, polytetrafluoroethylene (PTFE).
[0058] Persons of ordinary skill in the art will appreciate that the embodiments encompassed by the present disclosure are not limited to the particular exemplary embodiments described above. In that regard, although illustrative embodiments have been shown and described, a wide range of modification, change, and substitution is contemplated in the foregoing disclosure. It is understood that such variations may be made to the foregoing without departing from the scope of the present disclosure. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the present disclosure.