HK1235658B - Accommodating intraocular lens device - Google Patents

Description

Adjusting the intraocular lens device

Technical Field

The present invention generally relates to an accommodating intraocular lens device and, more particularly, to an accommodating intraocular lens device configured for implantation in the lens capsule or sulcus of an eye of a subject.

Background Art

Surgical procedures of the eye have been on the rise as technological advances have allowed for complex interventions to address a wide variety of ophthalmic conditions. Patient acceptance has increased over the past two decades as such procedures have been shown to be generally safe and produce results that significantly improve patients' quality of life.

Cataract surgery remains one of the most common surgical procedures, with more than 16 million cataract surgeries performed worldwide. This number is expected to continue to increase as life expectancy continues to rise. Cataracts are typically treated by removing the lens from the eye and implanting an intraocular lens ("IOL") in its place. Since conventional IOL devices are primarily used for farsightedness, they cannot correct presbyopia and still require reading glasses. Therefore, although patients who undergo standard IOL implantation no longer experience clouding from cataracts, they cannot adapt or change their focal length from near to far, from far to near, and to intermediate distances.

Surgery to correct refractive errors in the eye has also become very common, with LASIK being extremely popular, with over 700,000 procedures performed annually. Given the high prevalence of refractive errors and the relative safety and effectiveness of this surgery, more and more people are looking to turn to LASIK or other surgical procedures rather than conventional glasses or contact lenses. Despite the success of LASIK in treating myopia, there remains an unmet need for effective surgical interventions to correct presbyopia, which cannot be treated with conventional LASIK surgery.

Since nearly every cataract patient also suffers from presbyopia, the market demand for treatments for these two conditions is converging. While implantable intraocular lenses are widely accepted among physicians and patients for the treatment of cataracts, similar procedures for correcting presbyopia only account for 5% of the U.S. cataract market. Therefore, there is a need to address the prevalence of cataracts and/or presbyopia in the growing aging population.

Summary of the Invention

The accommodating intraocular lens (IOL) described herein combines the power-changing characteristics of a flexible membrane with those of a base lens. The power-changing characteristics of the IOL are driven by a fluid optic within an enclosed volume. A significant advantage of the IOL is that the enclosed volume separating the flexible membrane and the base lens maintains a substantially constant volume, avoiding many of the problems associated with fluid optic IOLs, which involve or require a varying volume, i.e., fluid supplied from a reservoir into a chamber. Many disadvantages exhibited by fluid optics requiring a varying volume include non-uniform power changes and/or non-uniform buckling of the flexible membrane. The IOL disclosed herein avoids these problems by maintaining a substantially constant or fixed volume and maintaining good optical quality throughout the power range. As power changes, the fluid redistributes itself within the enclosed volume. This design requires a significantly smaller volume of fluid than known IOL fluid optics requiring a reservoir. Due to the smaller IOL, the present invention offers the added benefit of reducing biocompatibility issues associated with larger IOLs and reducing the size of the incision required for lens implantation. This results in faster healing and more stable refraction.

The IOLs disclosed herein can be configured in any number of ways. In one embodiment, radial compressive forces applied to an implanted IOL can be concentrated onto the flexible membrane, causing the membrane's curvature to change. Simultaneously, the IOL is configured such that radial compressive forces are minimized or reduced relative to the optic. In one embodiment, at least 51%, at least 60%, at least 70%, at least 75%, at least 80%, at least 90%, at least 95%, at least 98%, at least 99%, or 100% of the radial compressive forces are applied to the flexible membrane. In another embodiment, 1% or less, 2% or less, 5% or less, 10% or less, 20% or less, 25% or less, 30% or less, 40% or 49% or less of the radial compressive forces are applied to the optic. However, the optic can be configured to displace axially toward the flexible membrane in response to changes in its curvature. This axial displacement can be facilitated by attaching the optic to the peripheral edge of the IOL in a manner that allows the optic to float. As the curvature of the flexible membrane changes, fluid adhesion or surface tension will operate to pull the optic toward the flexible membrane. Preferably, the optic resists or does not change curvature.

In another embodiment, the radial compressive force applied to the implanted IOL can be concentrated onto the optic to cause axial displacement of the optic. In one embodiment, at least 51%, at least 60%, at least 70%, at least 75%, at least 80%, at least 90%, at least 95%, at least 98%, at least 99%, or 100% of the radial compressive force is applied to the optic. In another embodiment, 1% or less, 2% or less, 5% or less, 10% or less, 20% or less, 25% or less, 30% or less, 40% or 49% or less of the radial compressive force is applied to the flexible membrane. In preferred embodiments, the optic itself resists or does not change curvature. Simultaneously, the IOL is configured such that the radial compressive force relative to the flexible membrane is minimized or reduced. However, the curvature of the flexible membrane will change in response to axial displacement of the lens.

In other embodiments, a radial compressive force applied to an implanted IOL can be applied to both the flexible membrane and the optic to cause a change in the curvature of the flexible membrane and an axial displacement of the optic toward the flexible membrane while maintaining a constant volume of the space therebetween. Preferably, the curvature of the flexible membrane changes while the optic displaces axially and resists or does not change curvature.

With respect to any embodiment, the thickness of the membrane can be uniform, or it can vary. In one embodiment, the membrane can have a thinner central region and a thicker peripheral region about the central axis A-A, which can allow for a larger optical power variation for a given amount of force. However, if the thickness ratio of the central region to the peripheral region of the membrane is too large, it can result in significant asphericity, reducing optical quality under compression and making it more difficult to manufacture. A thicker membrane in the center can make the IOL easier to manufacture, but can reduce potential optical power variation. Determination of the optimal membrane thickness and thickness uniformity is determined to maximize optical power variation and optical quality while minimizing manufacturing issues and costs. The membrane must also be thick enough to allow handling during the implantation procedure.

Due to its separate two-piece structure, the two-piece accommodating IOL device disclosed herein provides many advantages. Implantation of the IOL device requires a significantly reduced incision size because the two parts of the IOL device are implanted separately, and thus significantly reduces the delivery profile for implantation. The reduced incision size provides many advantages, including avoiding the need for anesthesia and suturing to close the incision site and improving surgical outcomes.

Additionally, greater control is provided in adjusting the size and power of the IOL during surgery. Implanting the base lens assembly in the lens capsule will provide the physician with an impression of the size of the patient's lens capsule and will therefore help verify the correct size of the lens of varying power that will subsequently be implanted.

In one embodiment, an accommodating IOL is described. The IOL can include an optic, a flexible membrane, and a peripheral edge connected to the optic and the flexible membrane. The peripheral edge can include an outer circumferential surface having a height and a force transfer area defined along a portion of the height of the outer circumferential surface. An enclosed volume can separate the optic and the flexible membrane. Preferably, the optic can be axially displaced when a radial compressive force is applied to the force transfer area, and the curvature of the flexible membrane can be changed about a central axis. The optic can have a greater rigidity than the membrane such that the optic can resist bending or a change in curvature when the optic is axially displaced and/or when a radial compressive force is applied to the force transfer area. Alternatively, the IOL can be implanted in a sulcus. The IOL can be designed so that it can be implanted in the sulcus of an eye with or without a natural lens (crystalline lens or intraocular lens IOL).

According to the first aspect, the force transmission area can be a circumferential ring. Preferably, the circumferential ring can protrude outwardly from the circumferential peripheral edge.

According to the second aspect, a fluid can be contained within the closed volume. Preferably, the fluid can be selected from the group consisting of silicone oil, fluorinated silicone oil and polyphenylene ether.

According to a third aspect, the accommodating IOL can further include a haptic system in contact with or coupled to the force-transmitting region.

According to a fourth aspect, an enclosed volume can be defined between the optics, the flexible membrane and the peripheral edge.

According to the fifth aspect, the volume that can be defined by the enclosed volume can remain fixed when the optical member is axially displaced and the curvature of the flexible membrane changes, and/or when a radial compressive force is applied to the force transmission area.

In another embodiment, a two-piece accommodating intraocular lens assembly is described. The two-piece accommodating intraocular lens assembly can include a base lens assembly and an accommodating IOL as described herein. The base assembly can include a base power optic and a haptic system circumferentially surrounding the base power optic. The haptic system can include an inner surface that faces the base power optic and defines an interior space within which the accommodating IOL can be removably retained.

According to the first aspect, only the force transmission area of the outer circumferential surface is in contact with the inner surface of the haptic system.

According to a second aspect, the base lens assembly can further comprise a support flange extending radially inwardly from the inner surface to contact the sides of the IOL including the optic and/or the flexible membrane.

According to a third aspect, a plurality of spaced apart notches can be provided around the outer surface of the haptic system.

According to a fourth aspect, the base power optic is capable of partially or fully resisting changes in curvature, or is capable of changing curvature in response to radial compressive forces applied to the haptic system.

In another embodiment, an accommodating IOL is described. The accommodating IOL can include an optic, a flexible membrane, and a circumferential peripheral edge including an inner side and an outer side. An enclosed volume can separate the optic and the flexible membrane. An optical coupler and a membrane coupler can be disposed from an inner side of the circumferential peripheral edge. A force transfer region can be disposed on an outer side of the circumferential peripheral edge. The force transfer region can be positioned along a portion of the outer side opposite the optical coupler and not positioned along a portion of the outer side opposite the membrane coupler. The force transfer region can concentrate the transfer of radial compressive forces applied thereto to the optic via the optical coupler to cause axial displacement of the optic along a central axis. Due to the enclosed volume and adhesion of the fluid to the membrane, the axial displacement of the optic can cause a change in the curvature of the flexible membrane.

According to the first aspect, the force transmission area can be a circumferential ring. Preferably, the circumferential ring can protrude outwardly from the circumferential peripheral edge.

According to the second aspect, a fluid can be contained within the closed volume. Preferably, the fluid can be selected from the group consisting of silicone oil, fluorinated silicone oil and polyphenylene ether.

According to the third aspect, the optic can have greater rigidity than the membrane, such that the optic can resist bending or changes in curvature when the optic is displaced axially and/or when radial compressive forces are applied to the force transmission region.

According to a fourth aspect, a circumferential channel can be defined between an inner side of the circumferential peripheral edge and the flexible membrane, the circumferential channel having an interior volume contained within the enclosed volume.

According to a fifth aspect, the haptic system can be in direct contact or connection with the force transmission area.

According to a sixth aspect, an enclosed volume can be defined between the optic, the flexible membrane and the circumferential peripheral edge.

According to the seventh aspect, when a radial compressive force is applied to the force transmission area, the volume of the enclosed volume can be kept fixed.

In another embodiment, a two-piece accommodating intraocular lens assembly is described. The two-piece accommodating intraocular lens assembly can include a base lens assembly and an accommodating IOL as described herein. The base assembly can include a base power optic and a haptic system circumferentially surrounding the base power optic, the haptic system having an inner surface defining an interior space within which the accommodating IOL is removably retained.

According to a first aspect, only the outer force transmission areas are in contact with the inner surface of the haptic system.

According to a second aspect, the base lens assembly can further comprise a support flange extending radially inwardly from the inner surface to contact the sides of the IOL including the optic and/or the flexible membrane.

According to a third aspect, a plurality of spaced apart notches can be provided around the outer surface of the haptic system.

According to a fourth aspect, the base power optic is capable of partially or fully resisting changes in curvature, or is capable of changing curvature in response to a radial compressive force applied to the haptic system.

In another embodiment, an accommodative IOL can include an optic, a flexible membrane, and a circumferential peripheral edge including an inner side and an outer side. An enclosed volume can provide a space between the optic and the flexible membrane. The optical coupler and the membrane coupler can each be disposed from the inner side of the circumferential peripheral edge. A force transfer region can be disposed on the outer side of the circumferential peripheral edge, the force transfer region being positioned along a portion of the outer side opposite the membrane coupler and not positioned along a portion of the outer side opposite the optical coupler. The force transfer region can concentrate the transfer of radial compressive forces applied thereto to the flexible membrane via the membrane coupler to cause a change in curvature of the flexible membrane about a central axis. Due to adhesion of the enclosed volume and the fluid to the optic, the change in curvature of the flexible membrane can cause a corresponding axial displacement of the optic.

According to the first aspect, the force transmission area can be a circumferential ring. Preferably, the circumferential ring can protrude outwardly from the circumferential peripheral edge.

According to the second aspect, a fluid can be contained within the closed volume. Preferably, the fluid can be selected from the group consisting of silicone oil, fluorinated silicone oil and polyphenylene ether.

According to a third aspect, the optical coupler can include a plurality of folded regions to allow the optical member to freely displace axially along the central axis in response to changes in curvature of the flexible membrane and/or when radial compressive forces are applied to the force transfer regions.

According to a fourth aspect, the haptic can be in direct contact or connection with the force transmission area.

According to a fifth aspect, an enclosed volume can be defined between the optic, the flexible membrane and the circumferential peripheral edge.

According to the sixth aspect, the enclosed volume can remain fixed when a radial compressive force is applied to the force transmission area.

In another embodiment, a two-piece accommodating intraocular lens assembly is described. The two-piece accommodating intraocular lens assembly can include a base lens assembly and an accommodating IOL as described herein. The base assembly can include a base power optic and a haptic system circumferentially surrounding the base power optic. The haptic system can define an interior space within which the accommodating IOL is removably retained.

According to a first aspect, only the outer force transmission areas can come into contact with the inner surface of the haptic system.

According to a second aspect, the base lens assembly can further comprise a support flange extending radially inwardly from the inner surface to contact the sides of the IOL including the optic and/or the flexible membrane.

According to a third aspect, a plurality of spaced apart notches can be provided around the outer surface of the haptic system.

According to a fourth aspect, the base power optic is capable of partially or fully resisting changes in curvature, or is capable of changing curvature in response to radial compressive forces applied to the haptic system.

In another embodiment, an accommodating IOL is provided. The IOL can include an optic, a flexible membrane, and a force-transmitting region connected to the optic and the flexible membrane.

The enclosed volume can separate the optical component and the flexible membrane. When a radial compressive force is applied to the force transmission region, the optical component can be axially displaced and the curvature of the flexible membrane can change about the central axis. The optical component can have a greater rigidity than the membrane such that the optical component resists bending or changing curvature when the optical component is axially displaced and/or when a radial compressive force is applied to the force transmission region.

From the following detailed description, other objects, features and advantages of the described preferred embodiments will become apparent to those skilled in the art. However, it should be understood that while indicating preferred embodiments of the present invention, the detailed description and specific examples are provided by way of illustration and not limitation. Many changes and modifications may be made within the scope of the present invention without departing from the spirit of the present invention, and the present invention includes all such modifications.

BRIEF DESCRIPTION OF THE DRAWINGS

Illustrative embodiments of the present disclosure are described herein with reference to the accompanying drawings, in which:

1A-1B are perspective views of alternative embodiments of an accommodating IOL.

2A-2B are cross-sectional views of an alternative embodiment of an accommodating IOL taken along 2AB-2AB of FIG. 1A .

2C is a cross-sectional view of another embodiment of an accommodating IOL taken along line 2C-2C of FIG. 1B .

FIG3A is a perspective view of a basic lens assembly.

FIG. 3B is a cross-sectional view of the basic assembly taken along line 3B-3B of FIG. 3A .

4A is a cross-sectional view of an assembly of a two-piece accommodating intraocular lens comprising the accommodating IOL of FIG. 2A assembled within the basic lens assembly of FIG. 3A.

4B is a cross-sectional view of an assembly of a two-piece accommodating intraocular lens comprising the accommodating IOL of FIG. 2B assembled within the basic lens assembly of FIG. 3A.

4C is a cross-sectional view of an assembly of a two-piece accommodating intraocular lens comprising the accommodating IOL of FIG. 2C assembled within the basic lens assembly of FIG. 3A.

Like reference numerals refer to like parts throughout the several views of the drawings.

DETAILED DESCRIPTION

Specific, non-limiting embodiments of the present invention will now be described with reference to the accompanying drawings. It should be understood that such embodiments are by way of example and illustrate only a small number of embodiments within the scope of the present invention. Various changes and modifications apparent to those skilled in the art to which the present invention pertains are deemed to be within the spirit, scope, and intent of the present invention as further defined in the appended claims.

The contents of the following commonly owned and co-pending U.S. patent applications are incorporated herein by reference as if fully set forth herein: U.S. patent application serial number 13/662,087, filed on October 26, 2012, which was published as U.S. publication number 2013/0053954 on February 28, 2013; U.S. patent application serial number 13/725,895, filed on December 21, 2012, which was published as U.S. publication number 2014/0180403 on June 26, 2014; U.S. patent application serial number 61/899,110, filed on November 1, 2013; and U.S. patent application serial number 61/899,106, filed on November 1, 2013.

Fig. 1A illustrates an embodiment of an accommodating IOL 10, which comprises a flexible membrane 12, an optical component 14, and a peripheral edge 16 connecting the flexible membrane 12 and the optical component 14. The peripheral edge 16 is shown as having a height and a circumference. A portion of the height adjacent to the flexible membrane 12 is stepped outwardly to define a force transmission region 18, and a portion of the height adjacent to the optical component 14 is stepped inwardly 20 to define a region that minimizes contact with the lens capsule or sulcus or basic assembly of the eye in which it is implanted, or maintains a gap or spacing relationship with the lens capsule or sulcus or basic assembly of the eye in which it is implanted, as shown in Fig. 4 A and Fig. 4B. In a preferred embodiment, the central axis A-A of the accommodating IOL 10 preferably coincides around the optical axis of the eye, and the optical axis passes through the center of the cornea (not shown) of the eye across the retina. The accommodating IOL 10 of Fig. 1A can be configured in any number of alternative embodiments, including the embodiment shown in Fig. 2 A and Fig. 2B.

FIG1B shows another embodiment of an accommodating IOL 50 comprising a flexible membrane 52, an optical element 54, and a peripheral edge 56 connecting the flexible membrane 52 and the optical element 54. As with the accommodating IOL 10 of FIG1A , the peripheral edge 56 is shown as having a height and a circumference. However, in the accommodating IOL 50 of FIG1B , a portion of the height that is stepped outward to define a force transmission region 58 is adjacent to the optical element 54, and a portion that is stepped inward 60 is adjacent to the flexible membrane 52, defining an area that minimizes contact with the lens capsule, sulcus, or base assembly when implanted, or maintains a clearance or spaced relationship with the lens capsule, sulcus, or base assembly when implanted, as shown in FIG4C . As with the embodiment of the accommodating IOL 10 of FIG1A , the central axis A-A of the accommodating IOL 50 is preferably coincident about the optical axis of the eye. The accommodating IOL 50 of FIG1B can be configured in any number of embodiments, including the embodiment shown in FIG2C .

As shown in Figures 1A and 1B, force-transfer regions 18, 58 are located at different positions relative to peripheral edges 16, 56. The different positions of force-transfer regions 18, 58 serve to focus the transmission of radial compressive forces applied to IOL 10, 50 when implanted in the capsular bag or sulcus of the eye during accommodation. The mechanisms of accommodation in the natural eye and the implantation of accommodating IOLs are more fully described in co-pending U.S. Serial Nos. 61/889,106 and 61/899,110, the entire contents of which are incorporated herein by reference as if fully set forth herein. Once implanted in the lens capsule or sulcus of the eye, IOL 10, 50 is subjected to radial compressive forces generated by the relaxation of the ciliary muscle during accommodation. Force-transfer regions 18, 58 are in direct contact with the capsular bag or sulcus and, therefore, capture or focus the transmission of radial compressive forces onto the IOL, and specifically onto specific IOL structures connected to or adjacent to force-transfer regions 18, 58.

In one embodiment, the force transfer areas 18, 58 can have a height of 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, 5% or less, 2% or less, or 1% or less of the overall height of the peripheral edges 16, 56, respectively.

The force-transmitting regions 18 in the IOL 10 of FIG. 1A are located on opposite sides of the flexible membrane 12. Due to this location, the force-transmitting regions 18 concentrate and transmit radial compressive forces to the flexible membrane 12, causing deformation or curvature of the flexible membrane 12. In one embodiment, at least 51%, at least 60%, at least 70%, at least 75%, at least 80%, at least 90%, at least 95%, at least 98%, at least 99%, or 100% of the radial compressive forces are applied to the flexible membrane. The force-transmitting regions 18 in this embodiment preferably do not extend to the side opposite the optic 14 to limit or prevent the radial compressive forces from being transferred to the optic 14. In another embodiment, 1% or less, 2% or less, 5% or less, 10% or less, 20% or less, 25% or less, 30% or less, 40% or 49% or less of the radial compressive forces are applied to the optic. Thus, the stepped portion 20 experiences little, if any, radial compressive force by providing a clearance or spaced relationship with the capsular bag or sulcus or base component of the eye in which it is implanted, shown as 110 and 210 in Figures 4A and 4B, respectively.

The force-transmitting region 58 in the IOL 50 of FIG. 1B is located on the opposite side of the optic 54. Due to this location, the force-transmitting region 58 concentrates and transmits radial compressive forces onto the optic 54, causing axial displacement of the optic 54 along the axis A-A. In one embodiment, at least 51%, at least 60%, at least 70%, at least 75%, at least 80%, at least 90%, at least 95%, at least 98%, at least 99%, or 100% of the radial compressive force is applied to the optic. The direction of the axial displacement will depend on how the optic 54 is connected to the peripheral edge 56, i.e., whether it is arched toward or away from the flexible membrane 52. In the embodiment shown in FIG. 2C , the optic 304 is arched toward the flexible membrane 302 and, therefore, will respond to the radial compressive force by axially displacing toward the flexible membrane 302. Again, by contrast, by providing a clearance or spacing relationship with the capsular bag, sulcus, or base assembly of the eye in which it is implanted, the stepped portion 310 experiences little, if any, radial compressive force, as shown in FIG. 4C . In another embodiment, 1% or less, 2% or less, 5% or less, 10% or less, 20% or less, 25% or less, 30% or less, 40% or 49% or less of the radial compressive force is applied to the flexible membrane. Preferably, the optical member 54 resists any change in curvature during axial displacement or when a radial compressive force acts on the force transmitting region 58.

2A-2C illustrate various alternative embodiments of IOLs based on IOL 10 of FIG. 1A or IOL 50 of FIG. 1B .

FIG2A shows an IOL 100 comprising a flexible membrane 102, an optic 104, and a circumferential peripheral edge 106 connecting the flexible membrane 102 and the optic 104. A membrane coupler 112 is disposed from the inside of the circumferential peripheral edge 106 to connect the membrane 102 to the peripheral edge 106. The membrane coupler 112 can have a thickness that is approximately the same as or less than the height of the force transfer region 108. Similarly, an optical coupler 114 is disposed from the inside of the circumferential peripheral edge 106 to connect the optic 104 to the peripheral edge 106. Preferably, the optical coupler 114 is angled toward the flexible membrane 102 such that it bends the optic 104 into an arched shape toward the flexible membrane 102.

As shown in FIG2A , the circumferential edge 106 is shown as having a substantially flat surface and a height defined along the central axis A-A. The circumferential edge 106 can optionally include at least two regions: a force-transmitting region 108 capable of receiving and transmitting a majority of the radial compressive forces applied thereto during the eye's accommodation process, and a stepped region 110 that receives and transmits no majority of the radial compressive forces. In one embodiment, the force-transmitting region receives approximately 75% or more, approximately 80% or more, approximately 90% or more, approximately 95% or more, approximately 98% or more, approximately 99% or more, or 100% or more of the compressive forces applied thereto during the eye's accommodation process. In another embodiment, the stepped region 110 receives approximately 25% or less, approximately 20% or less, approximately 25% or less, approximately 10% or less, approximately 5% or less, approximately 2% or less, approximately 1% or less, or none of the compressive forces applied thereto during the eye's accommodation process. 4A . The force transfer region 108 is intended to contact and engage the lens capsule or sulcus of the eye when implanted directly therein, or to contact the inner surface 422 of the base lens assembly 400 (see FIG. 4A ) when used as part of a two-piece accommodating intraocular lens assembly. The force transfer region 108 concentrates the transfer of radial compressive forces applied thereto to the flexible membrane 102 via the membrane coupler 112 to induce a change in the curvature of the flexible membrane 102. Thus, the force transfer region 108 is disposed on the outside of the circumferential peripheral edge 106 and is positioned along a portion of the outside opposite the membrane coupler 112, and preferably not along a portion of the outside opposite the optical coupler 114. The portion of the side opposite the optical coupler 114 is preferably the stepped region 110.

An enclosed volume 103 is provided within the IOL 100 to separate the flexible membrane 102 and the optic 104. The enclosed volume 103 is not in fluid communication with the exterior of the IOL 100, and therefore its volume remains fixed. Because the fixed volume and the optic 104 are arched toward the flexible membrane 102 by the optical coupler 114, the flexible membrane 102 and the optic 104 are substantially prevented from deflecting from each other when a radial compressive force is applied to the force-transmitting region 108. The fact that the enclosed volume 103 extends beyond the circumference of the optic 104 serves to further isolate the optic 104 from being directly subjected to the radial compressive force applied to the force-transmitting region 108.

The change in curvature of the flexible membrane 102 provides an accommodative optical power change via a radial compressive force. As the curvature of the flexible membrane 102 changes, the optical element 104 displaces axially toward the flexible membrane 102. This allows the flexible membrane 102 to change shape in an optically uniform manner using a constant volume of fluid, thereby avoiding the problem of non-uniform buckling of the flexible membrane. The dashed line in FIG2A illustrates the change in curvature of the flexible membrane 102 and the axial displacement of the optical element 104 when a radial compressive force is applied to the force transfer region 108 to produce the desired optical power change. The deformation of the membrane at the dashed line shown in FIG2A is smooth and exhibits good optical quality. High-period buckling is eliminated, which avoids the creation of a wavy or corrugated surface that would exhibit poor optical quality.

FIG2B illustrates an alternative embodiment of an IOL 200. As with the IOL 100 of FIG2A , the IOL 200 of FIG2B includes a flexible membrane 202, an optic 204, and a circumferential peripheral edge 206 connecting the flexible membrane 202 and the optic 204. A membrane coupler 212 is provided from the inside of the circumferential peripheral edge 206 to connect the membrane 202 to the peripheral edge 206. An optical coupler 214 is provided from the inside of the circumferential peripheral edge 206 to connect the optic 204 to the peripheral edge 206. In contrast to the IOL 100 shown in FIG2A , the optical coupler 214 is not configured to cause the optic 204 to bend into an arched shape toward or away from the flexible membrane 202. In contrast, the optical coupler 214 configured with a series of accordion-like undulations allows the optic 204 to movably float in opposite directions along the optical or central axis AA in response to changes in the curvature of the flexible membrane 202 caused by radial compressive forces acting on the force transfer region 208 .

2A , the circumferential peripheral edge 206 includes a force transfer region 208 disposed on the outside of the peripheral edge 206 along a portion opposite the membrane coupler 212. Preferably, the force transfer region 208 does not extend to a portion outside opposite the optical coupler 214. The portion outside opposite the optical coupler 214 is a stepped portion 210. The enclosed volume 203 maintains a gap or spacing relationship between the flexible membrane 203 and the optic 204 and performs substantially the same function as described with respect to the enclosed volume 103 of FIG2A .

The change in curvature of the flexible membrane 202 provides an accommodative optical power change via a radial compressive force. As the curvature of the flexible membrane 202 changes, the optical element 204 displaces axially toward the flexible membrane 202. This allows the flexible membrane 202 to change shape in an optically uniform manner using a constant volume of fluid, thereby avoiding the problem of non-uniform buckling of the flexible membrane. The dashed line in FIG2B illustrates the change in curvature of the flexible membrane 202 and the axial displacement of the optical element 204 when a radial compressive force is applied to the force transfer region 208 to produce the desired optical power change. The deformation of the membrane at the dashed line, as shown in FIG2B , is smooth and exhibits good optical quality. High-period buckling is eliminated, which avoids the creation of a wavy or corrugated surface that would otherwise exhibit poor optical quality.

2C shows an IOL 300 comprising a flexible membrane 302, an optic 304, and a circumferential peripheral edge 306 connecting the flexible membrane 302 and the optic 304. A membrane coupler 312 connects the flexible membrane 302 to the peripheral edge 306, and an optical coupler 314 connects the optic 304 to the peripheral edge 306.

Peripheral edge 306 includes a force transfer region 308 and a stepped region 310. Unlike the configuration of the peripheral edge shown in Figures 2A and 2B, force transfer region 308 is positioned on the outside of peripheral edge 306 along a portion opposite optical coupler 314. Preferably, force transfer region 308 does not extend to a portion of the outside opposite film coupler 312. This configuration allows force transfer region 308 to focus the transmission of radial compressive forces applied thereto to optical element 304 via optical coupler 314 to cause axial displacement of optical element 314 along central axis A-A. In one embodiment, at least 51%, at least 60%, at least 70%, at least 75%, at least 80%, at least 90%, at least 95%, at least 98%, at least 99%, or 100% of the radial compressive force is applied to optical element 604. In another embodiment, 1% or less, 2% or less, 5% or less, 10% or less, 20% or less, 25% or less, 30% or less, 40% or 49% or less of the radial compressive force is applied to the flexible membrane 302. The optical coupler 314 is preferably angled toward the flexible membrane 302 such that when a radial compressive force is applied to the force transfer region 308, the optical coupler 314 displaces the optical member 304 axially toward the flexible membrane 302.

2A and 2B , the curvature of the flexible membrane 302 is indirectly altered due to the radial compressive force. The axial displacement of the optical element 304 pushes the fluid contained in the enclosed volume 304 and exerts a force on the inner surface of the flexible membrane 302 facing the optical element 304. Therefore, the fluid force exerted on the flexible membrane 302 due to the axial displacement of the optical element 304 directly causes the curvature of the flexible membrane 302 to change.

In a preferred embodiment, the IOL 300 further includes a circumferential channel 305 in fluid communication with and contained within the volume defining the enclosed volume 303. The circumferential channel 305 is disposed between the inner side of the circumferential peripheral edge 306 and the flexible membrane 302 and functions to further isolate the flexible membrane 302 from direct radial compressive forces exerted on the peripheral edge 306 and/or the force-transmitting region 308, such that the curvature of the flexible membrane 302 changes substantially, if not entirely, as a direct result of the fluid pressure from the axial displacement of the optic 304.

The change in curvature of the flexible membrane 302 provides an accommodative optical power change via a radial compressive force. As the optical element 304 is axially displaced toward the flexible membrane 302, the curvature of the flexible membrane 302 changes. This allows the flexible membrane 302 to change shape in an optically uniform manner using a constant volume of fluid, thereby avoiding the problem of non-uniform buckling of the flexible membrane. The dashed line in FIG2C illustrates the change in curvature of the flexible membrane 302 and the axial displacement of the optical element 304 in the presence of a radial compressive force on the force transfer region 308 to produce the desired optical power change. The deformation of the membrane at the dashed line shown in FIG2C is smooth and will have good optical quality. High-period buckling is eliminated, which avoids the creation of a wavy or corrugated surface that would have poor optical quality.

The fluid contained within the enclosed volumes 103, 203, and 303 of Figures 2A-2C can be any fluid, preferably selected from the group consisting of silicone oil, fluorinated silicone oil, and polyphenylene ether. According to one embodiment, the fluid (213, 313, 413, 513) can be polyphenylene ether ("PPE"), as described in U.S. Patent No. 7,256,943, entitled "Variable Focus Liquid-Filled Lens Using Polyphenyl Ethers," issued to Teledyne Licensing, LLC, the entire contents of which are incorporated herein by reference as if fully set forth herein.

According to another embodiment, the fluid can be a fluorinated polyphenylene ether ("FPPE"). FPPE has the unique advantage of providing tunability of refractive index while being a chemically inert, biocompatible fluid with dispersive properties. Tunability is provided by increasing or decreasing the phenyl and fluorine content of the polymer. Increasing the phenyl content will effectively increase the refractive index of the FPPE, while increasing the fluorine content will decrease the refractive index of the FPPE while reducing the permeability of the FPPE fluid through the wall of the IOL.

In another preferred embodiment, the enclosed volume may be filled with a gel. The gel preferably has a refractive index of at least 1.46, 1.47, 1.48 or 1.49. The gel may also preferably have a Young's modulus of 20 psi or less, 10 psi or less, 4 psi or less, 1 psi or less, 0.5 psi or less, 0.25 psi or less and 0.01 psi or less. In a preferred embodiment, the gel is a cross-linked polymer, preferably a cross-linked silicone polymer, and more preferably a cross-linked phenylsiloxane polymer, such as a vinyl terminated phenylsiloxane polymer or a vinyl terminated diphenylsiloxane polymer. In addition to silicone polymers, other optically clear polymer liquids or gels may be used to fill the enclosed cavity, and these polymers may be branched, unbranched, cross-linked or uncross-linked or any combination of the foregoing.

Compared to most liquids, gels have the following advantages: extended molecular weight from crosslinking, greater self-adhesion, and adherence to the walls or opposing sides of the IOL. This makes the gel less likely to leak through the walls of the IOL. To achieve a combination of adjustable optical power and relatively small deformation in the curvature of the power-varying lens, the gel is selected to have a high refractive index while being made from an optically transparent material characterized by a low Young's modulus. Therefore, in preferred embodiments, the gel has a refractive index of 1.46 or greater, preferably 1.47 or greater, 1.48 or greater, and most preferably 1.49 or greater. At the same time, the gel preferably has a Young's modulus of 10 psi or less, preferably 5 psi or less, and more preferably 1 psi or less. In particularly preferred embodiments, the gel has a Young's modulus of 0.5 psi or less, preferably 0.25 psi or less, and most preferably 0.01 psi or less. It will be appreciated that at lower Young's modulus, the gel will exhibit less resistance to deformation, and therefore for a given unit of applied force, the deformation of the power-changing lens 110 will be greater.

The IOL described in Figures 1 and 2A-2C can be implanted directly into the lens capsule or sulcus of the patient's eye, with the flexible membrane or optic positioned posteriorly. Alternatively, the IOL can be provided as part of a two-piece accommodating intraocular lens assembly, as shown in Figures 4A-4C, which include a base lens assembly 400 and an IOL.

3A-3B illustrate an embodiment of a base lens assembly 400 comprising a base power optic 410 and a haptic system, which is disclosed as circumferentially surrounding the base power optic 410. The haptic system comprises an inner surface 422 and an outer surface 420, which are sized and shaped to contact the lens capsule or sulcus of the eye when implanted. The inner surface 422 is sized and dimensioned to accommodate an IOL such that the inner surface 422 engages the force transfer area of the IOL. In one embodiment, the inner surface 422 is a substantially flat surface. The haptic system can also include a plurality of arms 412 having protrusions or surfaces 424 to engage a surface of the IOL comprising one of the optic or the flexible membrane. The haptic system also comprises a plurality of flanges 426 extending radially inward from the inner surface 422 to engage a surface of the IOL comprising the other of the surfaces comprising the optic or the flexible membrane. The engagement surface 424 and flange 426 cooperate to securely hold the IOL within the base lens assembly 400 and prevent the IOL from being removed from the base lens assembly 400. A plurality of spaced apart notches 421 around the outer surface of the haptic system may also be provided to allow for radial compression of the haptic system.

4A-4C illustrate a fully assembled two-piece accommodating intraocular lens assembly comprising an assembled IOL (100, 200, 300) and a base lens assembly 400. It can be seen that the force-transmitting regions (108, 208, 308) of each IOL are in close contact with the inner surface 422 of the haptic system. Additionally, the flange 426 and the engagement surface 424 are shown in close contact with the side of the IOL comprising the flexible membrane and the side of the IOL comprising the optic, respectively. While one orientation of the IOL within the base lens assembly 400 is shown, it should be understood that the IOL can be flipped and positioned within the base lens assembly 400 in the opposite orientation, with the optic on top and the flexible membrane facing the base lens 410 of the base lens assembly 400. In a preferred embodiment, a gap is provided between the inner surface 422 of the haptic system 420 and the stepped portion (110, 210, 310). This gap provides space so that forces are not transferred directly, if at all, to the stepped portion (110, 210, 310) through radial compression of the base lens assembly 400.

The implantation of a two-piece accommodative intraocular lens assembly can be carried out in two steps, first performing the implantation of the basic assembly 400, and then performing the implantation and assembly of the IOL in the basic assembly 400. The advantage of this two-step method is that it reduces the required incision size of the lens with a substantially larger range of accommodation. In addition, the two-step method also provides flexibility in two orientations of the IOL, wherein the first one positions the flexible membrane in front of the eye, and the second one positions the flexible membrane in the back of the eye. The clinician can determine and select appropriate orientation based on the patient's visual needs. In addition, the basic assembly after the implantation can be used to determine the size and optical power of the IOL to be implanted.

Example 1

An IOL similar to the IOL shown in FIG2A was modeled with a total diameter of 7 mm and a center thickness of 1.2 mm, except that the membrane was 200 microns in the center and 100 microns at the periphery. The model included a fluid with a refractive index of 1.49 within the enclosed volume of the IOL. Various modulus materials were modeled and evaluated by finite element analysis. The results demonstrated a 5D power change with a 3mm aperture. The initial diopter power was 22.0D and the final diopter power was 27.2D.

Example 2

The IOL in Example 1 was constructed using optical-quality silicone material for the membrane, and the enclosed volume was filled with a silicone fluid with a refractive index of 1.49. Testing was performed with an artificial capsule under a similar loading configuration as in Example 1. The measured dioptric power change using a 3 mm aperture was 5.5 D. The power ranged from 23 D to 28.5 D, with acceptable optical quality throughout the power change.

Example 3

The IOL tested in Example 2 was then placed inside a basic lens assembly, which was placed inside an artificial lens capsule. The basic lens assembly was similar in design to the lens shown in Figure 3A. The test was carried out under similar loading conditions as in Example 2. The basic power lens had a power of -8.5D, and the power variation lens had a power of 23.0D. When the IOL and basic lens assembly were assembled together, the combined power was measured at 14.5D with a 3mm aperture. The dioptric power variation measured using a 3mm aperture was 5.5D. The dioptric power varied from 14.5D to 21.0D with acceptable optical quality throughout the power variation range.

The scope of the present invention as described and claimed herein is not limited by the specific preferred embodiments disclosed herein, as these embodiments are intended to illustrate several aspects of the present invention. Indeed, various modifications of the present invention, in addition to those shown and described herein, will become apparent to those skilled in the art from the foregoing description. Such modifications are also intended to fall within the scope of the appended claims.

Claims (10)

1. A two-piece accommodating intraocular lens assembly comprising: Adjusting the intraocular lens, also known as IOL, involves: Optical components; flexible membrane; a peripheral edge connected to the optical member and the flexible membrane, the peripheral edge including an outer circumferential surface having a height and a force transmission area defined along a portion of the height of the outer circumferential surface adjacent the flexible membrane; and an enclosed volume separating the optical member and the flexible membrane and configured to contain a fluid; and a base lens assembly comprising a base optical power optic and a haptic system circumferentially surrounding the base optical power optic, the haptic system having an outer surface configured to engage a capsular bag of a patient's eye and an inner surface in engaging contact with the force-transmitting region of the accommodating IOL; wherein the force transfer region concentrates transfer of radial compressive force applied thereto to the flexible membrane to induce a change in curvature of the flexible membrane, and wherein fluid adhesion acts to pull the optical member toward the flexible membrane as the curvature of the flexible membrane changes. 2. The two-piece accommodating intraocular lens assembly of claim 1 wherein the force transfer region is a circumferential ring. 3. A two-piece accommodating intraocular lens assembly according to claim 2, wherein the circumferential ring projects outwardly from the peripheral edge. 4. The two-piece accommodating intraocular lens assembly of claim 3 further comprising a fluid contained within the enclosed volume. 5. The two-piece accommodating intraocular lens assembly of claim 4, wherein the fluid is selected from the group consisting of silicone oil and polyphenylene ether. 6. A two-piece accommodating intraocular lens assembly according to claim 5, wherein the enclosed volume is defined between the optic, the flexible membrane and the peripheral edge. 7. A two-piece accommodating intraocular lens assembly according to claim 6, wherein when said radial compressive force is applied to said force transfer area, the volume defined by said enclosed volume remains fixed. 8. A two-piece accommodating intraocular lens assembly according to claim 7, wherein only the force transmitting area of the outer circumferential surface is in contact with the inner surface of the haptic system. 9. The two-piece accommodating intraocular lens assembly of claim 8, wherein the base lens assembly further comprises a support flange extending radially inward from the inner surface to contact the side of the IOL including the flexible membrane. 10. A two-piece accommodating intraocular lens assembly according to any preceding claim, further comprising a plurality of spaced apart notches disposed about the outer surface of the haptic system.