This application relates to a fluid lens component configured to be coupled with an intraocular lens device and methods of preparing the same.
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 28 million cataract procedures being performed worldwide per year. It is expected that this number will continue to increase as average life expectancies continue to rise. 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 designed to provide clear distance visions, they fail to correct for presbyopia. As a result, reading glasses are still required. Thus, although the vision of patients who undergo a standard IOL implantation will not be clouded by the cataract, they are unable to change focus from far to near.
Implanting an IOL in the eye of a patient that utilizes a fluid lens can enable a patient to change focus from far to near, improving the adaptability of the patient's vision. Care must be taken in preparing such a lens to maintain accommodative capacity, appropriate flexibility, and optical clarity as such may be compromised by contamination along the optical axis, and/or leakage of optical fluid.
Accordingly, there is a need for an IOL device that utilizes a fluid lens that can be prepared and placed in the capsular bag following capsulotomy and provide enhanced outcomes for patients. Enhanced outcomes can be in a variety of forms. For instance, accommodative IOL components (e.g., fluid lenses) disclosed herein have a channel that receives a joining substance to couple an anterior member and posterior member of the IOL components together. The channel and a proximate inclined interface between the anterior member and posterior member can restrict the joining substance to a predetermined area. Restricting the joining substance to a predetermined area reduces, minimizes or eliminates contamination of an optical fluid, which could degrade a patient's vision along the optical axis. Restricting the joining substance to the predetermined area also helps to maintain flexibility of accommodative components and the optical fluid such that the fluid lens avoids increased stiffness due to the unrestrained spread of the joining substance. Another enhanced outcome is the use of a plug to obstruct a port through which an optical fluid flows into a closed cavity of the IOL component. The plug can be configured to receive a syringe for filling a fluid space in the IOL component. The plug can reduce, minimize, or eliminate optical fluid leakage from the IOL component which can cause reduced accommodative capacity.
In some variants, a method of assembling a fluid lens is provided. An anterior member having an anterior optical surface and a first peripheral portion is provided. A posterior member having a posterior optical surface and a second peripheral portion is provided. A joining substance is applied to one or both of an anterior surface of the second peripheral portion or a posterior surface of the first peripheral portion. The anterior surface of the second peripheral portion is coupled with the posterior surface of the first peripheral portion using the joining substance. A closed cavity is formed between the anterior optical surface and the posterior optical surface by forming a seal between the first peripheral portion and the second of the peripheral portion.
In some variants, applying a joining substance can include flowing a liquid material into a channel formed in the anterior surface of the second peripheral portion or into a channel formed in the posterior surface of the first peripheral portion.
In some variants, applying a joining substance includes flowing a liquid material into a channel formed in the anterior surface of the second peripheral portion.
In some variants, the method can include enclosing the channel to block flow of the joining substance into the closed cavity. In some variants, enclosing the channel can include engaging an inclined interface formed between a second inclined surface of the second peripheral portion and a first inclined surface of the first peripheral portion.
In some variants, the method can include confirming that the closed cavity is substantially free of the joining substance. In some variants, the method can include detecting a visible color mixed with the joining substance.
In some variants, an intraocular lens component is provided. The intraocular lens component has an anterior side having an anterior optical surface disposed across an optical axis of the lens component. The intraocular lens component has a posterior side having a posterior optical surface disposed across the optical axis. The intraocular lens component has a peripheral portion having an anterior portion coupled to the anterior side. The intraocular lens component has a posterior portion coupled to the posterior side. The intraocular lens component has a joining channel disposed in one or both of the anterior portion and the posterior portion. The intraocular lens component has a joining substance disposed in the joining channel to bond the posterior portion of the peripheral portion to the anterior portion of the peripheral portion.
In some variants, the joining substance includes a pigment or dye that can facilitate visualization of an orientation of an intraocular lens. In some variants, the pigment or dye is closer to the anterior side or posterior side.
In some variants, the joining substance forms a continuous feature in the peripheral portion that is configured to visually verify assembly of an intraocular lens when viewed from the anterior side. In some variants, the continuous feature is an annular structure that surrounds the optical axis of the lens component. In some variants, the continuous feature can be visually disrupted under a retaining feature of the intraocular lens to visually verify the assembly of the intraocular lens when viewed from the anterior side.
In some variants, the intraocular lens component includes an inclined interface disposed in the peripheral portion between the posterior portion and the anterior portion. In some variants, the inclined interface has an anterior inclined surface and a posterior inclined surface, the inclined interface being disposed between the joining channel and a closed cavity. In some variants, the closed cavity is between the anterior optical surface and the posterior optical surface.
In some variants, the intraocular lens component includes a material that can adhere to a surface of a base member upon contact. In some variants, an anterior surface of the anterior portion, a posterior surface of the posterior portion, and a peripheral surface of the peripheral portion are rough to facilitate improved adhesion to the surface of the base member upon contact. In some variants, the peripheral surface of the peripheral portion is rough to facilitate improved adhesion to the surface of the base member upon contact.
In some variants, an intraocular lens device includes an intraocular lens component and a base member. The base member can have a haptic that can engage a capsular bag of an eye of a patient. The base member can have one or more retention features. The base member can include a material that can adhere to a surface of the IOL component upon contact. In some variants, the base member can have a radially inward facing wall, posterior surface of the one or more retention members, and/or one or more tables. The base member can have a receiving space that is adjacent the radially inward facing wall and/or between the one or more retention members and the one or more tables. The receiving space can receive the IOL component. The radially inward facing wall, posterior surface of the one or more retention members, and/or one or more tables can be rough to facilitate improved adhesion to surface(s) of the IOL component upon contact.
In some variants, a method of preparing a fluid lens component is provided. A fluid lens component having a closed cavity disposed between an anterior optical member, a posterior optical member, and a peripheral portion is provided. The peripheral portion has a peripheral surface having a port extending toward the closed cavity. The anterior optical member has a first surface on an anterior side of the fluid lens and a second surface opposite the first surface. The second surface is at least partially bounding the closed cavity. A tubular member is advanced into and through the port such that the tubular member extends into the closed cavity. An optical fluid is dispensed in the closed cavity to provide a continuous expanse of the optical fluid adjacent to the second surface of the anterior optical member. The tubular member is withdrawn from the port.
In some variants, the fluid lens component has a solid wall disposed between an inward end of the port and the closed cavity. In some variants, advancing the tubular member includes piercing the solid wall to provide access to the closed cavity through the port.
In some variants, dispensing the optical fluid includes positioning a tip of the tubular member at a side of the closed cavity opposite the port and withdrawing the tip as the fluid is flowing into the closed cavity. In some variants, the method includes forming a plug in the port after withdrawing the tubular member from the port.
In some variants, an intraocular lens component is provided. The intraocular lens component includes an anterior side including an anterior optical surface disposed across an optical axis of the lens component. The intraocular lens component has a posterior side having a posterior optical surface disposed across the optical axis. The intraocular lens component includes a peripheral portion coupled to the anterior side. The posterior side, the peripheral portion, and anterior side form a closed cavity therebetween. The port has a first end disposed at a peripheral surface of the peripheral portion and a second end disposed within the peripheral portion between the first end and the closed cavity.
In some variants, a solid and continuous expanse of material extends between the second end of the port and the closed cavity. In some variants, the intraocular lens component includes a channel formed between the second end of the port and the closed cavity for access to the closed cavity by a syringe. The channel is self-sealing in the absence of the syringe. In some variants, the intraocular lens component includes an optical fluid disposed in the closed cavity. In some variants, the intraocular lens component includes a plug member disposed in the port.
In some variants, an intraocular lens component is provided. The intraocular lens component has an anterior side having an anterior optical surface disposed across an optical axis of the intraocular lens component. The intraocular lens component has a posterior side having a posterior optical surface disposed across the optical axis. The intraocular lens component includes a peripheral portion coupled to the anterior side and the posterior side. A fluid-filled cavity extends between the anterior optical surface, posterior optical surface, and peripheral portion. The intraocular lens component has a base member including a haptic that can engage a capsular bag of an eye of a patient and one or more resilient retention features having an inner end biased posteriorly into a receiving space configured to receive the (IOL) component. The one or more resilient retention features can be moved in an anterior direction to facilitate placing the IOL component into the receiving space of the base member and to be released to be moved toward an anterior surface of the peripheral portion of the IOL component.
In some variants, the resilient retention feature can, upon being released after the IOL component is disposed in the base member, apply a normal force on the anterior surface of the peripheral portion of the IOL component.
In some variants, the IOL component has a notch that can receive one or more of the resilient retention features when the IOL component is at a pre-defined rotational position relative to the base member.
In some variants, the IOL component has an anterior-posterior thickness that is larger than an anterior-posterior thickness of the receiving space such that the IOL component causes the one or more resilient retention features to flex anteriorly upon assembly of the IOL component within the base member.
In some variants, a method of assembling an intraocular lens (IOL) device within an eye of a patient is provided. A base member having a base optic and one or more resilient retention features that have an inner end biased posteriorly toward the base optic is inserted into an eye of a patient. The one or more resilient retention features are moved anteriorly relative to a free state of the resilient retention feature. The intraocular lens (IOL) component is inserted into a receiving space between the one or more resilient retention features and an opposite portion of the base member. The one or more resilient retention features are released such that the one or more resilient retention features contact an anterior surface of the IOL component.
In some variants, releasing the one or more resilient retention features can result in the one or more resilient retention feature(s) moving into a notch in the IOL component.
In some variants, the one or more resilient retention features applies a normal force to the anterior surface of the IOL component.
In some variants, the method further includes contacting a peripheral surface of the IOL component with a radially inward facing surface of the base member.
In some variants, the anterior surface of the IOL component anteriorly deflects the one or more resilient retention features.
These and other features, aspects and advantages are described below with reference to the drawings, which are intended for illustrative purposes and should in no way be interpreted as limiting the scope of the embodiments. Furthermore, various features of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure. In the drawings, like reference characters denote corresponding features consistently throughout similar embodiments. The following is a brief description of each of the drawings.
This application discloses a multi-component IOL device 100 (e.g., accommodating IOL device, accommodating IOL). The multi-component IOL device 100 has an IOL component 200 (e.g., a fluid lens, a power changing lens). The IOL component 200 has an anterior member 300 and a posterior member 400 that are joined together via a joining substance 204. A closed cavity 208 is provided between the anterior and posterior members 300, 400 that can receive a liquid material 230. Various configurations of the IOL component 200 and methods of preparing the same are disclosed herein.
Providing clear focus is one of the chief aims of surgery in the front part of the eye. The IOL device 100 described herein achieves this objective and in addition is adapted to provide clear focus not only at distance but also up close, e.g., from near to far, in various embodiments. Thus the IOL device 100 is uniquely configured to provide premium performance for patients.
A. Eye Anatomy and Accommodation
An equatorial region 32 of the capsular bag 30 is coupled to a ciliary muscle 50 by zonules 40. The zonules 40 are connective tissues that can stretch the capsular bag 30. When the ciliary muscle 50 is in a rest state, the zonules 40 are stretched and apply a tension force to the capsular bag 30. When the eye 10 attempts to accommodate, the ciliary muscle 50 contracts, reducing the tension in the zonules 40. These accommodation processes result in a compression force on a base member 500 of the IOL device 100 as discussed further below. Without being bound to a particular theory, it is believed that the capsular bag 30 contracts when the tension in the zonules 40 is reduced and the contraction applies a compression force to the base member 500 to cause accommodation of an IOL component 200 within the base member 500. The ocular forces of the eye 10 are sufficient to change the shape of one or more optical surface of the IOL component 200, resulting in accommodation.
B. Separate Component Intraocular Lens Structure
The base member 500, as shown in
The joining substance 204 can include a pigment and/or dye such that the joining substance 204 has a color (e.g., yellow) that is visible. The intensity of the color can impact visibility with higher intensity colors being more visible than lower intensity colors. In some embodiments, the joining substance 204 can be opaque, which can include being non-transmissive of less than 10%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or greater than 90% of light thereon. In some embodiments, the joining substance 204 can be reflective, which can include reflecting less than 10%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or greater than 90% of light thereon. In some embodiments, the joining substance 204 can be fluorescent such that the joining substance 204 emits light at a particular wavelength after absorbing light at another wavelength. In some embodiments, the joining substance 204 emits light when exposed to specific wavelengths and, upon removal of the light source, ceases or almost immediately ceases to emit light. This can advantageously allow for selective visibility or intensity of visibility based upon exposure to specific light sources. Accordingly, the joining substance 204 can be exposed to a specific light source such that light is selectively emitted during assembly of the IOL component 200 or IOL device 100 but not emitted, absent the specific light source, during normal use after implantation in the eye of a patient. For example, fluorescence of the joining substance 204 can occur when the absorbed radiation is ultraviolet light (invisible to the human eye) while the emitted light is a distinct color in the visible region. After removal of the ultraviolet light source, the fluorescence of the joining substance 204 can almost immediately cease. In some embodiments, the joining substance 204 is phosphorescent and continues to emit light for a duration of time after a radiation source is removed.
The pigment and/or dye can facilitate visualization of an orientation of the IOL device 100 and/or IOL component 200 and/or relative position of one or more components of the base member 500 or the IOL component 200. The pigment and/or dye of the joining substance 204 can be closer to the anterior side 301 or posterior side 401. Stated differently, the joining substance 204 can be closer to the anterior side 301 or posterior side 401. For example, as shown in
In some aspects, the joining substance 204 can form a continuous feature in the peripheral portion 206 of the IOL component 200 that can be used to visually verify assembly of the IOL device 100 when viewed from the anterior side 301. The continuous feature can be an annular structure, which can surround an optical axis AA of the IOL component 200. The continuous structure can aid in confirming proper integration of the IOL component 200 with the base member 500. For example, the continuous feature can be visually disrupted under a retaining feature 502 of the base member 500 to visually verify the proper assembly of the IOL component 200 within the base member 500 when viewed from the anterior side of the IOL device 100. In other words, a visual inspection of a properly assembled IOL device 100 would provide at least two, e.g., three, elongate colored (e.g., yellow) arcs interrupted by at least two, e.g., three, relatively short circumferential spans of the retaining features 502 of the base member 500.
The IOL component 200 can have a closed cavity 208 (shown in
The posterior member 400 has a posterior optical member 403 (e.g., posterior optic, second optical member, lens body). In one embodiment, the posterior optical member 403 is a biconvex lens, which can have a fixed power. The posterior optical member 403 has a posterior optical surface 402 (e.g., second optical surface) on the posterior side of the fluid lens component 200, posterior member 400, and posterior optical member 403. The posterior optical member 403 has a first surface 405 (e.g. anterior optical surface of the posterior optical member 403) opposite the posterior optical surface 402. The first surface 405 is the anterior surface of the posterior optical member 403.
The anterior optical member 303 is spaced away from the posterior optical member 403. The anterior optical surface 302 is spaced away from the posterior optical surface 402. The anterior optical surface 302 is disposed away from the posterior optical surface 402 in a free state. When a compressive force is applied to the periphery portion 206 of the IOL component 200, the configuration of the IOL component 200 can be changed to provide a higher optical power. For example, the anterior optical surface 302 can bend such that the surface of the anterior optical surface 302 is steeper, providing greater power. In some embodiments, movement of the anterior optical surface 302 relative to the posterior optical surface 402 can result in a change of (e.g., greater) power. In some examples a combination of relative movement between the surfaces 302, 402 and bending of the surface 302 provides a change in (e.g., greater) power. In some variants, the posterior optical surface 402 moves anteriorly when a compressive force is applied to the peripheral portion 206 of the IOL component 200. In some variants, the second optical surface 402 does not substantially move as a result of compression.
The compression of the IOL component 200 can arise when the peripheral surface 210 of the peripheral portion 206 is engaged with the base member 500 and when compressive forces applied to the haptic 510 results in compressive forces being applied to the peripheral surface 210, causing the IOL component 200 to accommodate.
The anterior member 300 including the anterior optical surface 302 is spaced apart from the posterior member 400 including the posterior optical surface 402 by a closed cavity 208 that can be filled with a liquid or gel material. Stated differently, the closed cavity 208 is between the anterior optical surface 302 and the posterior optical surface 402. The closed cavity 208 is between the anterior optical member 303 and the posterior optical member 403. The closed cavity 208 also is between an anterior optical surface of the posterior member 400 and a posterior optical surface of the anterior member 300. In some variants, the anterior optical surface 302 and the posterior optical surface 402 are spaced apart from each other in both an unaccommodated and accommodated state. The liquid or gel material in the closed cavity 208 can move towards or away from central and peripheral regions of the closed cavity 208 as the shape and/or curvature of the closed cavity 208 and anterior optical surface 302 change during accommodation. In some embodiments, the liquid or gel material is displaced as a result of an action on the anterior member 300 (e.g., bending of the optical surface 302) or the posterior member 400 (shifting of the position of the posterior surface 402 along the optical axis OA).
The anterior member 300 and the posterior member 400 are joined together by the peripheral portion 206, as shown in
As shown in
The cavity 307 of the anterior member 300 is bounded by the posterior surface 305 of the anterior optical member 303 and an inner peripheral surface 309. The inner peripheral surface 309 can be curved and posteriorly extend outward from the optical axis OA. The inner peripheral surface 309 can couple to the posterior surface 305 of the anterior optical member 303 at a position that is anterior to the posterior optical member 403 and spaced radially outward relative to where the anterior optical surface 302 couples to the peripheral portion 206. In the unaccommodated state of the IOL component 200, the inner peripheral surface 309 extends anteriorly relative to the anterior surface 405 of the posterior optical member 403 and posteriorly relative to where the posterior coupler 404 connects to the optical member 403 and/or a mid-plane of the posterior optical member 403. In an accommodated state, in some embodiments, the inner peripheral surface 309 extends posteriorly relative to the posterior optical surface 402. The inner peripheral surface 309 posteriorly extends to engage with a second inclined surface 410 of the posterior member 400, described in detail below.
The inner peripheral surface 309 is offset from the posterior coupler 404 when the IOL component 200 is assembled. The inner peripheral surface 309, anterior surface or surface 407 of the posterior coupler 404, and second inclined surface 410 cooperate to define a peripheral region 211 of the closed cavity 208. The peripheral region 211 is positioned radially outward relative to the anterior optical member 303 and the posterior optical member 403.
The IOL component 200 can be configured in several ways. In one embodiment, compression of the peripheral portion 206 causes the anterior optical surface 302 to bend. At the same time, the lens body 403 can be less directly controlled by such compression. For example, the lens body 403 can be more loosely coupled to the peripheral portion 206 such that the lens body 403 is allowed to shift anteriorly with anterior bending of the anterior optical surface 302. The lens body 403 can shift posteriorly upon relaxation of the anterior optical surface 302. In some embodiments, the movement of fluid within the closed cavity 208 caused by bending of the anterior optical surface 302 shifts (e.g., pulls, pushes, or simply allows a following of) the lens body 403 anteriorly and posteriorly. In another embodiment, compression of the peripheral portion 206 directly causes the second optical surface 402 to move anteriorly. For example, the posterior coupler 404, in some embodiments, can transfer compressive forces applied to the peripheral portion 206 such that the second optical surface 402 and posterior optical member 403 are moved anteriorly. Conversely, in the absence of compressive forces being applied to the peripheral portion 206, the second optical surface 402 and the posterior optical member 403 can shift back posteriorly.
The IOL component 200 has a channel 408 that can receive joining substance 204. The channel 408 is formed in the peripheral portion 206 of the IOL component 200. As shown in
As shown in
An arm 412 of the posterior member 400 extends anteriorly away from the posterior side 401 at an angle relative to the optical axis OA. The angle between the optical axis OA and the arm 412 can be less than 10, 10-20, 20-30, 30-40, 40-50, 50-60, 60-70, or greater than 70 degrees. The arm 412 defines a portion of the channel 408. Specifically, the arm 412 can define the outer surface of the channel 408. As shown in
The exterior surface of the arm 412 can also be angled posteriorly toward the optical axis OA such that the posterior member 400 is out of contact with the base member 500 at the arm 412 when the IOL component 200 is positioned in the base member 500. Being out of contact with the base member 500 results in a reduction of load applied directly through the posterior member 400. A load applied through compression of the ciliary body is transferred to the peripheral surface 210 and thereafter to the anterior optical surface 302. This configuration enhances or focuses load transferred in this manner to bend the surface 302.
When the anterior member 300 is interfaced with the posterior member 400, the arm 412 can extend into a groove 314 (e.g., annular groove, recess), as shown in
In some variants, no groove 314 and/or circumferential lip 308 is/are present, as shown in
Returning to
The inner peripheral surface 309, described previously herein, posteriorly extends to engage with the second inclined surface 410. The second inclined surface 410 is connected to the posterior coupler 404 such that the coupling position is posterior to and/or radially inward from where the inner peripheral surface 309 engages with the second inclined surface 410. The posterior coupler 404 and the second inclined surface 410 can be coupled at a position that is posterior to or posteriorly as the posterior optical surface 402. The second inclined surface 410 and the posterior coupler 404 can be angled relative to each other at an angle of less than 50, 50-60, 60-70, 70-80, 80-90, 90-100, 100-110, 110-120, 120-130, or greater than 130 degrees. A corner 415 can define the inner transition between the posterior coupler 404 and the second inclined surface 410. A curve 413 can define the outer transition between the posterior coupler 404 and the second inclined surface 410.
The inclined interface 212 can include a recess 311 (e.g., curved recess, groove). The first inclined surface 310 of the anterior side 300 can extend away from the recess 311. The recess 311, as shown in
The IOL component 200 can be prepared by forming and assembling the anterior and posterior members 300, 400 thereof and then by filling the close cavity 208, as follows.
A. Formation and Coupling of Anterior and Posterior Sides
After formation of the anterior member 300 and the posterior member 400, a joining substance 204 is used to join (e.g, couple, adhere, or secure along a seam) the anterior member 300 to the posterior member 400. A joining substance 204 can be applied to one or both of an anterior surface of the second peripheral portion 406 or a posterior surface of the first peripheral portion 306 for coupling. In some variants, a channel 408 (e.g., joining channel, annular recess) disposed and/or formed in one or both of the first peripheral portion 306 and the second peripheral 406 is filled with or partially filled with the joining substance 204. The channel 408 can be a continuous structure that can aid in confirming orientation of the IOL component 200 and proper integration of the IOL component 200 with the base member 500. As shown in
As shown in
The channel 408 is enclosed to block the flow of the joining substance 204 into the closed cavity 208. More specifically, enclosing the channel 408 can include engaging the inclined interface 212 formed between the second inclined surface 410 of the second peripheral portion 406 and the first inclined surface 310 of the first peripheral portion 306. A cap portion 315 of the posterior surface of the first peripheral portion 306 covers the open side of the channel 408 to further enclose the channel 308. In some variants, the peak 411 and recess 311 engage between the channel 408 and the closed cavity 208 to further prevent joining substance 204 from flowing into the closed cavity 208. The peak 411 and recess 311 can engage at an anterior position relative to the cap portion 315 of the posterior surface of the first peripheral portion 306 that covers the channel 306.
The combination of the recess 311 and peak 411 along with the inclined interface 212 provide multiple barriers to migration or flow of the joining substance 204 toward the closed cavity 208. The enclosure of the IOL component 200 can be formed by coupling the anterior member 300 to the posterior member 400 with the posterior member 400 below the anterior member 300. The joining substance 204 will thus have to flow up toward the peak 411 to flow over toward to closed cavity 208. Such flow will be impeded by the recess 311 which caps the peak 411. Further, the interface 212 will involve direct contact between the inclined surfaces 310, 410. Such direct contact will reduce, minimize, or eliminate flow paths from the peak 411 capped by the recess 311 toward the closed cavity 208.
The closed cavity 208 is formed between the anterior optical surface 302 and the posterior optical surface 402 by forming a seal between the first peripheral portion 306 of the anterior member 300 and the second peripheral portion 406 of the posterior member 400. The closed cavity 208 can be bounded by a posterior surface 305 of the anterior member 300 and an anterior surface 405 of the posterior member 400. The posterior surface 305 and an inclined inner periphery 309 of the first peripheral portion 306 form a concave recess 307 in which a portion of the posterior member 400, e.g., the anterior surface 405 of the posterior member 400 and in some cases a majority of a bi-convex optic of the posterior member 400 can be disposed in an at-rest condition. The closed cavity 208 can be bounded by an anterior surface or surfaces 407 of the posterior coupler 404 and the anterior surface 405 of the posterior member 400. The anterior surface or surfaces 407 of the posterior coupler 404 and the anterior surface 405 of the posterior member 400 can form a convex projection at least partially and in some cases mostly received in the concave recess 307 of the anterior member 300. The joining substance 204 couples the first peripheral portion 306 and the second peripheral portion 406 together such that the joining substance 204, which can include cooperation with the inclined interface 212, form a seal that prevents fluid and/or gel to be disposed in the closed cavity 208 (as discussed herein) from escaping the IOL component 200. The visible quality of the joining substance 204 enables visual confirmation that the closed cavity is substantially free or entirely free of the joining substance 204.
Excess joining substance 204 and/or material from the formation of the anterior member 300 and the second member 400 can result in flash forming on the peripheral portion 206 of the formed IOL component 200. Flash can be removed (e.g., cut, ground, smoothed) from the peripheral portion 206 such that the peripheral surface 210 is smooth. Providing a smooth peripheral surface 210, e.g., free of flash, can enhance or maintain responsiveness of the IOL component 200 to ocular forces which can be relatively small. Providing a smooth peripheral surface 210, e.g., free of flash, can reduce, minimize, or eliminate resistance to deformation of the anterior optical surface 302 by ocular forces.
B. Method of Filling and Closing the Closed Cavity
The enclosed chamber 208 can be accessible from the peripheral surface 210 of the peripheral portion 206, for example by a port 220 extending toward the closed cavity 208. In other embodiments, another optically peripheral structure of the IOL component 200 can include the port 220. The port 220 has a first end 222 (e.g., opening, outward end) disposed at the peripheral surface 210 and a second end 224 (e.g., wall, solid wall) disposed within the peripheral portion 206 between the first end 222 and the closed cavity 208. A solid and continuous expanse of material can extend between the second end 224 of the port 220 and the closed cavity 208. The port 220 can have a periphery with any shape, e.g., a circular shape. In some variants, other shaped peripheries can be employed. The port 220 can have a consistent size (e.g., diameter) from the first end 222 to the second end 224, or in some variants, the port 220 can have a varying size (e.g., a diameter that decreases in the first end 222 to second end 224 direction). In some cases, an access pathway is provided between the second end 224 and the closed cavity 208, e.g., a self-sealing structure or a structure that can seal to an injector.
In one technique, a tubular member 700 can be advanced into and through the port 220 such that the tubular member 700 extends into the closed cavity 208. Advancing the tubular member 700 into and through the port 220 can include piercing the second end 224 to provide access to the closed cavity 208.
Liquid material 230 (e.g., optical fluid, fluid, lens oil) or a gel is dispensed in the closed cavity 208 via the tubular member 700 to provide a continuous expanse of the liquid material 230 between the anterior optical surface 302 and the posterior optical surface 402, or between the posterior surface 305 of the anterior member 300 and the anterior surface 405 of the posterior member 400. As shown in
In some variants, a channel is formed between the second end 224 of the port 220 and the closed cavity 208 prior to insertion of the tubular member 300. The pre-formed channel provides access to the closed cavity 208 by a tubular member 700 (e.g., a syringe) with less resistance and greater precision and control. The tubular member 700 can be inserted through the channel and into the closed cavity 208 such that liquid material (e.g., fluid, optical fluid, gel) flows into the closed cavity 208 via the tubular member 700. The channel can be self-sealing in the absence of the tubular member 700 such that the channel closes preventing liquid material from escaping the closed cavity 208 in the absence of the tubular member 700. The channel can be blocked by the plug 202, as discussed above.
In some variants, a marker 240 is positioned on the tubular member 700, as shown in
As shown, the first peripheral portion 306 interfaces with the posterior surface 503 of the retaining feature 502, an radially inward facing surface 507 interfaces with the peripheral surface 210, and/or a table 505 interfaces with the posterior surface of the second peripheral portion 406 when the IOL component 200 is assembled with the base member 500. All or some of the forenamed surfaces can have adhesive qualities that can improve retention of the IOL component 200 within the base member 500.
In one embodiment the anterior surface of the first peripheral portion 306, a posterior surface of the second peripheral portion 406, and/or a peripheral surface 210 of the IOL component 200 can have adhesive characteristic around the entirety thereof. In one variation the adhesive quality of or on one or more of these surfaces can be spaced apart about the periphery of the component 200. Where the adhesive quality is spaced apart an expanse of the surface between the adhesive areas can be less or non-adhesive. By providing non- or less adhesive surface between the high or higher adhesive surfaces the IOL component 200 can be configured to be rotated within the base member 500 to a pre-defined position. As such the IOL component 200 can be placed in the base member 500 and then rotated until the higher adhesive surfaces of the IOL component 200 reaches the location of the retaining features 502. This facilitates achieving a pre-defined rotational position between the IOL component 200 and the base member 500. This can be useful for providing for correction of astigmatism or other rotationally varied optical power.
One advantage of making the interfacing surfaces of the base member 500 more adherent and allowing the surface of the IOL component to be less adherent relates to one method of implanting these components. In particular it is desired to minimize the invasiveness of the procedure. Injectors can be used to implant each of these components. The surfaces of the retaining features 502, the radially inward facing surface 507 and the table 505 mentioned above can be folded into a central position away from lumens of an injector. The surfaces of the IOL component 200 described as optionally being made more adherent may be exposed to walls of the lumen of the injector. As such, positioning the more adherent surface on the IOL component 200 may result in a higher injection force being required. So maintaining exterior surfaces of the IOL component 200 as low friction can be advantageous in some embodiments.
The surface area of the interfacing surfaces of the IOL component 200 and/or the base member 500 can be increased to facilitate improved adhesion between the surfaces of the IOL component 200 and the surfaces of the base member 500. Specifically, the surface area of the anterior surface of the first peripheral portion 306, a posterior surface of the second peripheral portion 406, and/or a peripheral surface 210 of the IOL component 200 can be increased to facilitate improved adhesion. Similarly, the surface area of the posterior surface 503 of the retaining feature 502, the radially inward facing surface 507, and/or the table 505 of the base member 500 can be increased to facilitate improved adhesion.
The surface area of the surfaces of the IOL component 200 and/or base member 500 can be increased with roughening. Roughening can be accomplished during the molding of the IOL component 200 and/or base member 500. Roughening can also be accomplished after the molding of the IOL component 200 and/or base member 500. In some embodiments, surfaces of the IOL component 200 and/or base member 500 are treated after molding to achieve a desired level of roughness (e.g., surface area). In some embodiments, the mold surfaces that form the surfaces of the IOL component 200 and/or base member 500 are roughened to form surfaces with a desired level of roughness (e.g., surface area). The mold surfaces can be roughened by electrical discharge machining (EDM), machining (milling and lathing), sand blasting, stamping, and/or other suitable techniques.
As illustrated in
During assembly, the one or more retention features 502 can be lifted (e.g., deflected, rotated) anteriorly, as indicated by the lifting force arrow L, to a new position 502′ that facilitates placing the IOL component 200 within the receiving space 511 and behind the one or more retention features 502. Upon removing the lifting force L, the one or more retention features 502 can apply the normal force N to the IOL component 200. Specifically, the one or more retention features can apply the normal force N to the anterior surface of the first peripheral portion 306. The normal force N can also be applied to the posterior surface of the second peripheral portion 406. This normal force N increases friction between the IOL component 200 and the base member 500 to facilitate improved retention. In some embodiments, the normal force N results in the peripheral portion 206 of the IOL component 200 being compressed (e.g., clamped, pinched) between the one or more retention members 502 and the one or more tables 505 without negatively impacting the accommodative responses of the IOL component 202.
Providing a posteriorly biased and resilient retention feature 502 can facilitate confirming that an IOL including the IOL component 200 and the base member 500 have been assembled in a pre-defined rotational position. For example, where an IOL including the IOL component 200 and the base member 500 is configured to mitigate astigmatism the IOL component 200 should be positioned at a pre-defined rotational position. The IOL component 200 can be configured to stop rotating when a portion thereof reaches the location of a resilient retention feature 502. For example, a radially oriented notch 300N can be provided on an anterior surface of the anterior member 300 of the IOL component 200, as shown in
As illustrated in
As used herein, the relative terms “proximal” and “distal” shall be defined from the perspective of the medical professional. Thus, proximal refers to the direction of the physician and distal refers to the direction of the eye when the surgeon is operating.
For expository purposes, the term “transverse” as used herein is defined as a direction generally perpendicular to the longitudinal axis of the assembly, unless otherwise specified.
Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments.
The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list.
The terms “approximately,” “about,” “generally,” and “substantially” as used herein represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms “approximately,” “about,” “generally,” and “substantially” may refer to an amount that is within less than 10% of the stated amount, as the context may dictate.
The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between” and the like includes the number recited. Numbers preceded by a term such as “about” or “approximately” include the recited numbers. For example, “about four” includes “four”
Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as “distally moving a locking element” include “instructing distal movement of the locking element.”
Although certain embodiments and examples have been described herein, it will be understood by those skilled in the art that many aspects of the humeral assemblies shown and described in the present disclosure may be differently combined and/or modified to form still further embodiments or acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure. A wide variety of designs and approaches are possible. No feature, structure, or step disclosed herein is essential or indispensable.
Some embodiments have been described in connection with the accompanying drawings. However, it should be understood that the figures are not drawn to scale. Distances, angles, etc. are merely illustrative and do not necessarily bear an exact relationship to actual dimensions and layout of the devices illustrated. Components can be added, removed, and/or rearranged. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with various embodiments can be used in all other embodiments set forth herein. Additionally, it will be recognized that any methods described herein may be practiced using any device suitable for performing the recited steps.
For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the disclosure may be embodied or carried out in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.
Moreover, while illustrative embodiments have been described herein, the scope of any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), adaptations and/or alterations as would be appreciated by those in the art based on the present disclosure. The limitations in the claims are to be interpreted broadly based on the language employed in the claims and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive. Further, the actions of the disclosed processes and methods may be modified in any manner, including by reordering actions and/or inserting additional actions and/or deleting actions. It is intended, therefore, that the specification and examples be considered as illustrative only, with a true scope and spirit being indicated by the claims and their full scope of equivalents.
This application is a U.S. National Phase of International Application No. PCT/US2020/064083, filed Dec. 9, 2020, which claims the priority benefit of U.S. Provisional Application No. 62/946,939, filed on Dec. 11, 2019, which is hereby incorporated by reference in its entirety herein. Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by referenced under 37 CFR 1.57.
Filing Document | Filing Date | Country | Kind |
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PCT/US2020/064083 | 12/9/2020 | WO |
Number | Date | Country | |
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62946939 | Dec 2019 | US |