The invention relates generally to an accommodating intraocular lens device and, more particularly, to an accommodating intraocular lens device configured for implantation in a lens capsule of a subject's eye.
Surgical procedures on the eye have been on the rise as technological advances permit for sophisticated interventions to address a wide variety of ophthalmic conditions. Patient acceptance has increased over the last twenty years as such procedures have proven to be generally safe and to produce results that significantly improve patient quality of life.
Cataract surgery remains one of the most common surgical procedures, with over 16 million cataract procedures being performed worldwide. It is expected that this number will continue to rise as average life expectancies continue to increase. Cataracts are typically treated by removing the crystalline lens from the eye and implanting an intraocular lens (“IOL”) in its place. As conventional IOL devices are primarily focused for distance visions, they fail to correct for presbyopia and reading glasses are still required. Thus, while patients who undergo a standard IOL implantation no longer experience clouding from cataracts, they are unable to accommodate, or change focus from near to far, from far to near, and to distances in between.
Surgeries to correct refractive errors of the eye have also become extremely common, of which LASIK enjoys substantial popularity with over 700,000 procedures being performed per year. Given the high prevalence of refractive errors and the relative safety and effectiveness of this procedure, more and more people are expected to turn to LASIK or other surgical procedures over conventional eyeglasses or contact lens. Despite the success of LASIK in treating myopia, there remains an unmet need for an effective surgical intervention to correct for presbyopia, which cannot be treated by conventional LASIK procedures.
As nearly every cataract patient also suffers from presbyopia, there is convergence of market demands for the treatment of both these conditions. While there is a general acceptance among physicians and patients of having implantable intraocular lens in the treatment of cataracts, similar procedures to correct for presbyopia represent only 5% of the U.S. cataract market. There is therefore a need to address both ophthalmic cataracts and/or presbyopia in the growing aging population.
In one embodiment, an accommodating intraocular lens (IOL) is provided. The IOL comprises an anterior lens, a posterior surface, and an articulating member joining the anterior lens and the posterior surface. The articulating member comprises anterior and posterior arms coupling the anterior lens and the posterior surface, respectively. The articulating member further comprises a peripheral portion. A posterior flex region is disposed about the posterior arm and at a distance from the peripheral portion. The posterior flex region permits the flexible posterior surface to articulate relative to the posterior arm, to decrease the radius of curvature of the posterior surface as the peripheral portions on opposing sides of the IOL move toward one another in a first state and to increase the radius of curvature of the posterior surface as the peripheral portions on opposite sides of the IOL move away from one another in a second state.
In accordance with a first aspect, the anterior lens, the posterior surface and the articulating member define an enclosed cavity and the outer surface of the anterior lens and the posterior surface form a substantially biconvex shape when the enclosed cavity is filled with a fluid.
In accordance with a second aspect, the anterior lens has a convex outer surface and the posterior surface has a concave outer surface.
In accordance with a third aspect, the articulating member has a wishbone shape and the anterior and posterior arms are movable in reciprocating.
In accordance with a fourth aspect, the articulating member further comprises an anterior flex region between the anterior lens and the anterior arm.
In accordance with a fifth aspect, the anterior flex region permits displacement of the anterior lens in an anterior direction when the IOL is in the first state.
In accordance with a sixth aspect, the anterior flex region has a reduced thickness as compared to either one or both of the anterior arm and the anterior lens.
In accordance with a seventh aspect, the posterior flex region is disposed between the flexible posterior surface and the posterior arm.
In accordance with an eighth aspect, the posterior flex region has a reduced thickness as compared to either one or both of the posterior arm and the flexible posterior surface.
In accordance with a ninth aspect, one or both of the anterior and posterior flex regions is/are groove(s) disposed circumferentially about the IOL.
In accordance with a tenth aspect, the peripheral portion has a thickness that is greater than the thickness of the anterior or posterior arms.
In accordance with an eleventh aspect, the peripheral portion defines an outer circumference of the IOL.
In accordance with a twelfth aspect, the articulating member resiliently biases the IOL in either one of the first state or the second state.
In accordance with a thirteenth aspect, the thickness of the posterior surface decreases radially from the outer to the center of the posterior surface.
In accordance with a fourteenth aspect, the IOL further comprises a resilient spacer coupled to the peripheral portion, the resilient spacer being configured to articulate between a contracted state and an expanded state to decrease and to increase, respectively, a diameter of the IOL. The diameter of the IOL is defined with respect to the overall diameter, including the resilient spacer.
In accordance with a fifteenth aspect, the resilient spacer surrounds the entire peripheral portion of the IOL.
In accordance with a sixteenth aspect, the resilient spacer comprises a plurality of radial arms projecting from the peripheral portion of the IOL.
In another embodiment, an accommodating intraocular lens (IOL) described. The IOL comprises an anterior lens, a posterior surface, and an articulating member joining the anterior lens and the posterior surface to form an enclosed cavity. The articulating member comprises anterior and posterior rings coupling the anterior lens and the posterior surface, respectively, to a peripheral portion. A first hinge is disposed between the anterior lens and the anterior ring and a second hinge is disposed between the posterior surface and the posterior ring.
In accordance with a first aspect, the first and second hinges have a decreased thickness as compared to the thickness of one or both of the anterior and posterior rings.
In accordance with a second aspect, the second hinge is a circumferential groove defining a circular area having a diameter.
In accordance with a third aspect, the IOL is configured to articulate between a first and second state.
In accordance with a fourth aspect, the peripheral portions on opposing sides of the IOL move towards one another to cause a decrease in the radius of curvature of the posterior surface in a first state.
In accordance with a fifth aspect, the peripheral portions on opposing sides of the IOL move away from one another to increase the radius of curvature of the posterior surface in a second state.
In accordance with a sixth aspect, the anterior lens and a portion of the posterior surface surrounding an optical axis each have a concave exterior surface.
In accordance with a seventh aspect, the anterior lens and a portion of the posterior surface surrounding an optical axis define a biconvex exterior surface.
In accordance with a eighth aspect, the portion of the posterior surface is stepped into the enclosed cavity.
In accordance with a ninth aspect, the IOL further comprises a plurality of holes disposed on the anterior ring.
In accordance with a tenth aspect, the enclosed cavity comprises separate inner and outer circumferential cavities and an expandable bellow that separates the inner and outer circumferential cavities.
In accordance with an eleventh aspect, only the outer circumferential cavity is in fluid communication externally of the IOL through the plurality of holes.
In accordance with a twelfth aspect, the expandable bellow comprises a light-absorbing material.
In accordance with a thirteenth aspect, the IOL further comprises an expandable membrane defining an external cavity and wherein enclosed cavity is in fluid communication with the external cavity through the plurality of holes.
In a further embodiment, an accommodating intraocular lens (IOL) configured for implantation in a lens capsule of a patient's eye is described. The IOL comprises a refractive anterior lens, a deformable posterior membrane, and an articulating member joining the refractive anterior lens and the posterior membrane to form an enclosed cavity. The articulating member comprises an anterior portion, a posterior portion, and a peripheral portion. The anterior portion has one end coupling the anterior lens and the other end coupling the peripheral portion. The posterior portion has one end coupling the posterior membrane and the other end coupling the peripheral portion. In a first state, opposing sides of the peripheral portion move toward one another to displace the anterior lens in an anterior direction and causing the radius of curvature of the posterior membrane to increase. In a second state, opposing sides of the peripheral portion move away from one another, displacing the anterior lens in a posterior direction and causing the radius of curvature of the posterior membrane to decrease.
Other objects, features and advantages of the described preferred embodiments will become apparent to those skilled in the art from the following detailed description. It is to be understood, however, that the detailed description and specific examples, while indicating preferred embodiments of the present invention, are given by way of illustration and not limitation. Many changes and modifications within the scope of the present invention may be made without departing from the spirit thereof, and the invention includes all such modifications.
Illustrative embodiments of the present disclosure are described herein with reference to the accompanying drawings, in which:
Like numerals refer to like parts throughout the several views of the drawings.
Specific, non-limiting embodiments of the present invention will now be described with reference to the drawings. It should be understood that such embodiments are by way of example and are merely illustrative of but a small number of embodiments within the scope of the present invention. Various changes and modifications obvious to one skilled in the art to which the present invention pertains are deemed to be within the spirit, scope and contemplation of the present invention as further defined in the appended claims.
The accommodating IOL device 100 is depicted in
The posterior surface 150 of the IOL device 100 may be of uniform thickness (
The accommodating IOL device 100 may be made of a variety of elastomeric materials. In one embodiment, the device 100 may be made entirely of a single elastomeric material. In another embodiment, the articulating member, which comprises the anterior arm 120, the peripheral portion and the posterior arm 140, may be made of a different material than the anterior lens 110 and/or the posterior surface 150. Alternatively, the articulating member may be made of the same material but having different mechanical and physical characteristics than either one or both of the anterior lens 110 and the posterior surface 150.
In accordance with one aspect, the articulating member may be made of a shape memory material which is resiliently biased to maintain an angle θ in the absence of any force or pressure applied onto the peripheral portion 130 of the IOL device 100. The angle θ may increase and decrease based on the relaxation and contraction, respectively, of the ciliary muscles when the IOL device 100 is implanted in the lens capsule 30 of the eye.
In accordance with another aspect, the articulating member may be made of a rigid material such that the anterior arm 120 and the posterior arm 140 do not articulate relative to one another. In accordance with this aspect, the angle θ remains substantially constant after implantation and during the relaxation and contraction of the ciliary muscles. As angle θ remains constant, there is a greater deflection of the anterior lens 110 and the posterior portion 150 about the anterior flex region or hinge 125 and the posterior flex region or hinge 145 when the ciliary muscles relax and contract. Moreover, having a rigid articulating member will translate into a greater change in curvature of the anterior lens 110 and the posterior portion 150 as compared to the embodiment in which the angle θ changes, in response to the relaxation and contraction of the ciliary muscles.
Turning first to the relevant anatomical features of the eye, the lens is a clear, elastic structure that is housed within a lens capsule 30 and maintained under tension via the ciliary muscles 50 which are coupled to the lens capsule 30 via zonule fibers 40. As a result, the lens naturally tends towards a rounder configuration, a shape it must assume for the eye to focus at a near distance.
The human eye comprises three chambers of fluid: the anterior chamber 12, the posterior chamber 20 and the vitreous chamber 60. The anterior chamber 12 corresponds generally to the space between the cornea 10 and the iris 14 and the posterior chamber 20 corresponds generally to the space bounded by the iris 14, the lens capsule 30 and the zonule fibers 40 connected to the periphery of the lens capsule 30. The anterior chamber 12 and the posterior chamber 20 contain a fluid known as the aqueous humor, which flows therebetween through an opening that is defined by the iris 14, known as the pupil 16. Light enters the eye through the pupil 16 and travels along the optical axis A-A, striking the retina 7 and thereby producing vision. The iris 14 regulates the amount of light entering the eye by controlling the size of the pupil 16.
The vitreous chamber 60 is located between the lens capsule 30 and the retina 70 and contains another fluid, known as the vitreous humor. The vitreous humor is much more viscous than the aqueous humor and is a transparent, colorless, gelatinous mass. Although much of the volume of the vitreous humor is water, it also contains cells, salts, sugars, vitrosin, a network of collagen type II fibers with glycosaminoglycan hyaluronic acid, and proteins. The vitreous has a viscosity that is two to four times that of pure water, giving it a gelatinous consistency. It also has a refractive index of 1.336.
Implantation of the IOL device 100 is accomplished by first removing the natural lens housed within the lens capsule 30 through a small incision using standard surgical procedures, such as phago-emulsification. After removal of the natural lens from the lens capsule 30, the IOL device 100 is introduced into the lens capsule 30 through the small incision. Once the IOL device 100 is positioned within the lens capsule 30, with the anterior lens 110 being centered about the optical axis A-A, the enclosed cavity 105 of the IOL device is filled with an appropriate fluid through a self-sealing valve disposed on the IOL. The volume of fluid used to fill the enclosed cavity 105 is understood to be tailored based size of the lens capsule 30 for each patient. In a desired embodiment, the volume is sufficient so as to permit engagement of the peripheral portion 130 with the zonule fibers 40 and the ciliary muscles 50.
The eye's natural mechanism of accommodation is reflected by the changes in the shape of the lens and thus the extent to which it refracts light.
In one embodiment, as shown in
Alternatively and as shown in
In cases where the fluid contained within the internal cavity 405 is not sufficiently biocompatible or is biohazardous,
In cases where the fluid is biocompatible, i.e., saline solution, the IOL device 400 depicted in
While
In all of the embodiments described herein, the relative thickness of the anterior lens 110 and the anterior arm 120 and the presence and thickness of the anterior hinge 125 will have an impact on the extent to which the anterior lens 110 is displaced translationally along the optical axis A and also on the extent to which the anterior lens 110 changes in curvature in response to the accommodating forces of the eye. For example, in embodiments where the anterior lens 110 is significantly thicker than either one or both of the anterior arm 120 and/or the anterior hinge 125 (e.g.,
The shape of the anterior lens, e.g., biconvex, concave, concave/convex, biconcave, may also be selected based on the refractive index of the fluid selected for the IOL device. For example, if the an anterior lens having a negative power may be more useful to obtain the correct change of power when the IOL device is stretched and relaxed, particularly where the refractive index of the anterior lens 110 and the posterior surface 150 are less than the refractive index of the fluid 105.
Moreover, the angle of the anterior arm 120 may also be configured to determine the extent and manner in which the anterior lens 110 will react to the changes in the eye's accommodating forces. For example, the anterior lens 110 would be expected to move in the direction in which the anterior arm 110 is angled. Thus, where the anterior arm 120 is angled anteriorly relative to a plane that is orthogonal to the optical axis, the anterior lens 110 is also expected to be displaced in the anterior direction when the eye is in an accommodated state. Where the anterior arm 120 is angled posteriorly relative to the same plane, the anterior lens is expected to be displaced in the posterior direction when the eye is in an unaccommodated state.
It is to be understood that the detailed description and specific examples, while indicating preferred embodiments of the present invention, are given by way of illustration and not limitation. Many changes and modifications within the scope of the present invention may be made without departing from the spirit thereof, and the invention includes all such modifications.
This application is a continuation of U.S. patent application Ser. No. 13/725,895, filed Dec. 21, 2012, the entire contents of which are incorporated herein by reference as if fully set forth herein.
Number | Name | Date | Kind |
---|---|---|---|
4373218 | Schachar | Feb 1983 | A |
4512040 | McClure | Apr 1985 | A |
4585457 | Kalb | Apr 1986 | A |
4720286 | Bailey et al. | Jan 1988 | A |
4731078 | Stay et al. | Mar 1988 | A |
4822360 | Deacon | Apr 1989 | A |
4842601 | Smith | Jun 1989 | A |
4888012 | Horn et al. | Dec 1989 | A |
4892543 | Turley | Jan 1990 | A |
4932966 | Christie et al. | Jul 1990 | A |
5035710 | Nakada et al. | Jul 1991 | A |
5091121 | Nakada et al. | Feb 1992 | A |
5275623 | Sarfarazi | Jan 1994 | A |
5443506 | Garabet | Aug 1995 | A |
5489302 | Skottun | Feb 1996 | A |
5607472 | Thompson | Mar 1997 | A |
6117171 | Skottun | Sep 2000 | A |
6730123 | Klopotek | May 2004 | B1 |
6855164 | Glazier | Feb 2005 | B2 |
6930838 | Schachar | Aug 2005 | B2 |
7063723 | Ran | Jun 2006 | B2 |
7122053 | Esch | Oct 2006 | B2 |
7217288 | Esch et al. | May 2007 | B2 |
7220279 | Nun | May 2007 | B2 |
7229475 | Glazier | Jun 2007 | B2 |
7247168 | Esch et al. | Jul 2007 | B2 |
7261737 | Esch et al. | Aug 2007 | B2 |
7416562 | Gross | Aug 2008 | B2 |
7438723 | Esch | Oct 2008 | B2 |
7453646 | Lo | Nov 2008 | B2 |
7485144 | Esch | Feb 2009 | B2 |
7637947 | Smith et al. | Dec 2009 | B2 |
7675686 | Lo et al. | Mar 2010 | B2 |
7753953 | Yee | Jul 2010 | B1 |
7776088 | Shadduck | Aug 2010 | B2 |
7815678 | Nun | Oct 2010 | B2 |
7842087 | Nun | Nov 2010 | B2 |
7854764 | Nun | Dec 2010 | B2 |
7857850 | Mentak et al. | Dec 2010 | B2 |
7981155 | Cumming | Jul 2011 | B2 |
7985253 | Cumming | Jul 2011 | B2 |
7998199 | Nun | Aug 2011 | B2 |
8018658 | Lo | Sep 2011 | B2 |
8034106 | Mentak et al. | Oct 2011 | B2 |
8034107 | Stenger | Oct 2011 | B2 |
8038711 | Clarke | Oct 2011 | B2 |
8048155 | Shadduck | Nov 2011 | B2 |
8052752 | Woods et al. | Nov 2011 | B2 |
8070806 | Khoury | Dec 2011 | B2 |
8158712 | Your | Apr 2012 | B2 |
8197541 | Schedler | Jun 2012 | B2 |
8216306 | Coroneo | Jul 2012 | B2 |
8254034 | Shields et al. | Aug 2012 | B1 |
8273123 | Nun | Sep 2012 | B2 |
8314927 | Choi et al. | Nov 2012 | B2 |
8320049 | Huang et al. | Nov 2012 | B2 |
8328869 | Smiley et al. | Dec 2012 | B2 |
8361145 | Scholl et al. | Jan 2013 | B2 |
8398709 | Nun | Mar 2013 | B2 |
8414646 | De Juan, Jr. et al. | Apr 2013 | B2 |
8425599 | Shadduck | Apr 2013 | B2 |
8447086 | Hildebrand et al. | May 2013 | B2 |
8454688 | Esch et al. | Jun 2013 | B2 |
8475529 | Clarke | Jul 2013 | B2 |
8545556 | Woods et al. | Oct 2013 | B2 |
8585758 | Woods | Nov 2013 | B2 |
8657878 | Mentak et al. | Feb 2014 | B2 |
8715346 | De Juan, Jr. et al. | May 2014 | B2 |
8734509 | Mentak et al. | May 2014 | B2 |
8814934 | Geraghty et al. | Aug 2014 | B2 |
8834565 | Nun | Sep 2014 | B2 |
8900298 | Anvar et al. | Dec 2014 | B2 |
20030093149 | Glazier | May 2003 | A1 |
20030105522 | Glazier | Jun 2003 | A1 |
20030149480 | Shadduck | Aug 2003 | A1 |
20040082993 | Woods | Apr 2004 | A1 |
20040082994 | Woods et al. | Apr 2004 | A1 |
20040111153 | Woods et al. | Jun 2004 | A1 |
20040148023 | Shu | Jul 2004 | A1 |
20040162612 | Portney et al. | Aug 2004 | A1 |
20040169816 | Esch | Sep 2004 | A1 |
20040181279 | Nun | Sep 2004 | A1 |
20050071002 | Glazier | Mar 2005 | A1 |
20050107873 | Zhou | May 2005 | A1 |
20050119740 | Esch et al. | Jun 2005 | A1 |
20050137703 | Chen | Jun 2005 | A1 |
20050251253 | Gross | Nov 2005 | A1 |
20050251254 | Brady et al. | Nov 2005 | A1 |
20060041307 | Esch et al. | Feb 2006 | A1 |
20060047339 | Brown | Mar 2006 | A1 |
20060074487 | Gilg | Apr 2006 | A1 |
20060100701 | Esch et al. | May 2006 | A1 |
20060155372 | Coroneo | Jul 2006 | A1 |
20060212116 | Woods | Sep 2006 | A1 |
20070010880 | Esch | Jan 2007 | A1 |
20070021831 | Clarke | Jan 2007 | A1 |
20070088433 | Esch et al. | Apr 2007 | A1 |
20070100445 | Shadduck | May 2007 | A1 |
20070106377 | Smith et al. | May 2007 | A1 |
20070118216 | Pynson | May 2007 | A1 |
20070129798 | Chawdhary | Jun 2007 | A1 |
20070129799 | Schedler | Jun 2007 | A1 |
20070129800 | Cumming | Jun 2007 | A1 |
20070129801 | Cumming | Jun 2007 | A1 |
20070185574 | Nun | Aug 2007 | A1 |
20070203578 | Scholl et al. | Aug 2007 | A1 |
20070213817 | Esch et al. | Sep 2007 | A1 |
20070244561 | Nun | Oct 2007 | A1 |
20070260310 | Richardson | Nov 2007 | A1 |
20080004699 | Nun | Jan 2008 | A1 |
20080015689 | Esch et al. | Jan 2008 | A1 |
20080033547 | Chang et al. | Feb 2008 | A1 |
20080046074 | Smith et al. | Feb 2008 | A1 |
20080046075 | Esch et al. | Feb 2008 | A1 |
20080154364 | Richardson et al. | Jun 2008 | A1 |
20080188930 | Mentak et al. | Aug 2008 | A1 |
20080269887 | Cumming | Oct 2008 | A1 |
20080300680 | Nun | Dec 2008 | A1 |
20080306588 | Smiley et al. | Dec 2008 | A1 |
20080306589 | Donitzky et al. | Dec 2008 | A1 |
20090005865 | Smiley et al. | Jan 2009 | A1 |
20090027661 | Choi et al. | Jan 2009 | A1 |
20090149952 | Shadduck | Jun 2009 | A1 |
20090204210 | Pynson | Aug 2009 | A1 |
20090264998 | Mentak et al. | Oct 2009 | A1 |
20090292355 | Boyd et al. | Nov 2009 | A1 |
20090319040 | Khoury | Dec 2009 | A1 |
20100030332 | Schedler | Feb 2010 | A1 |
20100094412 | Wensrich | Apr 2010 | A1 |
20100121444 | Nun | May 2010 | A1 |
20100131058 | Shadduck | May 2010 | A1 |
20100179653 | Argento et al. | Jul 2010 | A1 |
20100211169 | Stanley et al. | Aug 2010 | A1 |
20100228344 | Shadduck | Sep 2010 | A1 |
20100288346 | Esch | Sep 2010 | A1 |
20100324672 | Esch et al. | Dec 2010 | A1 |
20100324674 | Brown | Dec 2010 | A1 |
20110029074 | Reisin et al. | Feb 2011 | A1 |
20110082544 | Nun | Apr 2011 | A1 |
20110112636 | Nun | May 2011 | A1 |
20110118834 | Lo et al. | May 2011 | A1 |
20110160852 | Mentak et al. | Jun 2011 | A1 |
20110224788 | Webb | Sep 2011 | A1 |
20110282442 | Scholl et al. | Nov 2011 | A1 |
20110288638 | Smiley et al. | Nov 2011 | A1 |
20120035724 | Clarke | Feb 2012 | A1 |
20120071972 | Zhao | Mar 2012 | A1 |
20120078361 | Shadduck | Mar 2012 | A1 |
20120078364 | Stenger | Mar 2012 | A1 |
20120150292 | Mentak et al. | Jun 2012 | A1 |
20120290084 | Coroneo | Nov 2012 | A1 |
20120296423 | Caffey | Nov 2012 | A1 |
20120296424 | Betser | Nov 2012 | A1 |
20120310343 | Van Noy | Dec 2012 | A1 |
20130006353 | Betser et al. | Jan 2013 | A1 |
20130018461 | Nun | Jan 2013 | A1 |
20130035760 | Portney | Feb 2013 | A1 |
20130131794 | Smiley et al. | May 2013 | A1 |
20130150960 | DeBoer | Jun 2013 | A1 |
20130190867 | Peyman | Jul 2013 | A1 |
20130226295 | De Juan, Jr. et al. | Aug 2013 | A1 |
20130231741 | Clarke | Sep 2013 | A1 |
20130250239 | Hildebrand et al. | Sep 2013 | A1 |
20130268070 | Esch et al. | Oct 2013 | A1 |
20130317607 | DeBoer | Nov 2013 | A1 |
20140012277 | Matthews et al. | Jan 2014 | A1 |
20140135918 | De Juan, Jr. et al. | May 2014 | A1 |
20140249625 | Shadduck | Sep 2014 | A1 |
Number | Date | Country |
---|---|---|
0766540 | Aug 1999 | EP |
WO2009015226 | Jan 2009 | WO |
WO2011137191 | Nov 2011 | WO |
WO2013016804 | Feb 2013 | WO |
Number | Date | Country | |
---|---|---|---|
20160128826 A1 | May 2016 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 13725895 | Dec 2012 | US |
Child | 14936544 | US |