Patent Application
20160089232
In various embodiments, the present invention relates to intraocular lens designs and methods of treatment for posterior capsule opacification.
The crystalline lens of a human's eye refracts and focuses light onto the retina. Normally the lens is clear, but it can become opaque (i.e., when developing a cataract) due to aging, trauma, inflammation, metabolic or nutritional disorders, or radiation. While some lens opacities are small and require no treatment, others may be large enough to block significant fractions of light and decrease the visual acuity. In such cases, surgical removal of the cataract is often necessary.
Conventionally, cataract treatments involve surgically removing the opaque lens matrix from the lens capsule using, for example, manual extraction and aspiration, phacoemulsification, and/or application of a femtosecond laser through a corneal incision. An artificial intraocular lens (IOL, or simply “lens”) may then be implanted in the lens capsule bag to replace the crystalline lens (see, e.g., U.S. patent application Ser. No. 14/058,634, filed Oct. 21, 2013, the entire disclosure of which is incorporated by reference herein).
Generally, IOLs are made of a foldable, optically transparent polymeric material, such as silicone or acrylic, for minimizing the incision size and required stitches and, as a result, the patient's recovery time. The most commonly used IOLs are single-element lenses (or monofocal IOLs, non-accommodating IOLs, or non-focusing IOLs) that provide a single focal distance for distance vision. Typically, distance vision requires limited contraction of ciliary muscles in the eye (i.e., emmetropia); thus monofocal IOL designs are relatively simple. For example, to choose an appropriate geometry for a monofocal lens having a desired focusing power, limiting factors of the eye's anatomy, such as the axial eye length and the power of the cornea, are taken into consideration. However, because the focal distance is not adjustable following implantation of the monofocal IOL, patients implanted with such lenses can no longer focus on objects at a close distance (e.g., less than twenty-five centimeters); this results in poor visual acuity at close distances.
In some patients, after the implantation of the IOL, the posterior part of the lens capsule becomes opaque (due to, e.g., overgrowth of epithelium cells), triggering a condition called posterior capsule opacification (PCO). PCO decreases the amount of light that reaches the retina, causing a decrease in visual acuity. PCO is one of the most common complications after cataract extraction. Approximately 30-40% of the subjects who undergo cataract extraction and IOL implantation develop PCO and require treatment.
While such laser-based treatments have a reasonably high success rate, in some cases, the laser beam may damage the IOL, leading to a decrease in visual acuity and contrast and causing glare for the patient. Such damage may occur due to incorrect focusing of the laser energy. In some cases, however, the IOL is sufficiently close to the posterior capsule that even laser light correctly focused on the posterior capsule may damage the IOL. Such damage may range in severity from mild to moderate, and even severe. Mild damage may be characterized as small pits with raised smooth edges, while moderate damage may include deeper pits and/or large craters or small cracks, and severe damage may include severe cracking or crevice formation into the optic.
Recently, accommodating intraocular lenses (AIOLs) have been developed to provide adjustable focal distances (or accommodations) by relying on the natural focusing ability of the eye. Because an AIOL works closely in coordination with the eye tissue, the focusing power thereof is sensitive to the geometric properties of the eye tissue. For example, ciliary muscles of the eye may contract, causing a change in the diameter and/or the shape of the lens capsule accommodating the AIOL; this results in an adjustment of the focal distance. Additionally, the shorter the focal distance of the AIOL, the more sensitive the AIOL will be to a change in geometry of the eye tissue.
Most IOLs are made of single piece of hard material, although some newer IOLs have a two-lens design, and lenses filled with clear fluid have also been utilized. Most current IOLs are prefabricated for their lens power and then placed in the eye, but again, a few designs involve intraocular filling of the liquid in the lens at the time of initial surgery or possibly at a subsequent time (e.g., for adjustment or should the liquid become opacified, or even simply to exchange the liquid in the lens for a liquid of different properties (e.g., optical, viscosity, color)). A liquid-filled bag that provides accommodation—made from, for example, an elastic, biocompatible polymer—results in numerous benefits and advantages, e.g., the ability to adjust the lens following implantation; to customize the lens to the needs of each patient; to accommodate vision; sharper vision over a wide range of distances; and reduction of visual side effects such as glares and halos. See, e.g., U.S. Pat. No. 8,771,347, and U.S. patent application Ser. No. 13/473,012, filed May 16, 2012, the entire disclosure of each of which is hereby incorporated by reference.
Liquid-filled IOLs impose particular challenges for PCO treatments that open the posterior lens capsule. With liquid-filled IOLs, the laser energy may cause a rupture of the surrounding shell of the IOL, causing the liquid components to leak out and degradation of optical performance. For liquid-filled AIOLs, this may even damage the mechanism of accommodation.
In view of the foregoing, there is a need for IOL designs and treatment techniques that minimize or substantially eliminate complications resulting from PCO treatments.
In accordance with various embodiments of the present invention, PCO treatment techniques are modified to prevent or substantially eliminate damage to IOLs, and/or IOLs are designed to more robustly resist damage from PCO treatments. Various embodiments of the present invention may be used with any type of IOL, including conventional IOLs and liquid-filled IOLs.
Embodiments of the present invention treat or prevent PCO by opening the posterior lens capsule prior to (or concomitant with) IOL implantation, or moving the IOL away from the posterior lens capsule (i.e., posteriorly and/or equatorially) prior to and during the opening procedure. While embodiments of the invention involve removal of the posterior portion of the lens capsule after PCO formation, they may also be used preventatively to open an aperture in the posterior lens capsule before PCO formation. In this manner, the optical axis of the eye never has a degradation of visualization due to PCO formation, as cells cannot migrate to the optical axis.
In other embodiments of the invention, the posterior lens capsule is cut in a specific, perforated pattern before IOL implantation in order to reduce or substantially minimize the amount of, e.g., cutting or laser or ultrasound energy utilized to open the posterior lens capsule. Such embodiments may also be combined with IOL movement and/or spacing away from the posterior lens capsule. Patterning of the posterior lens capsule may be implemented in tandem with IOLs having markings indicating still-intact portions of the capsule requiring removal for complete opening of the capsule. The markings may be accompanied by, or may include or consist essentially of, strengthened and/or thickened portions of the IOL that are more resistant to the effects of laser treatments for opening the lens capsule. A visible-, optical-, or ultrasound-guided laser may be used to detect the markings (e.g., two or more points) in order to determine IOL position, position relative to the capsule, and appropriate areas in the sagittal plane to cut the lens capsule.
Techniques utilizable to cut the capsule in accordance with embodiments of the present invention include mechanical or laser removal (e.g., conventional Nd:YAG, femtosecond, nanosecond, excimer, diode, argon, attosecond, etc. lasers) or ultrasound sources. Measurement or guidance systems may be used with the cutting systems during the procedure (i.e., simultaneous image (real-time) systems), or such systems may be used to ensure appropriate spacing before the procedure. Examples of measurement or guidance systems include optical coherence tomography, ultrasound, ultrasound biomicroscopy, scheimpflug imaging, tomography, magnetic resonance imaging, aberrometery, and slit lamp illumination. In various embodiments, a guidance system and a posterior capsular opening system are used together. For example, OCT may be used to guide a femtosecond laser and plan the cut path of the posterior lens capsule.
In an aspect, embodiments of the invention feature a method of treating posterior capsule opacification (PCO) in a patient's eye comprising (i) a lens capsule having a posterior surface exhibiting (or at risk for) PCO, and (ii) an intraocular lens implanted within the lens capsule. The intraocular lens is urged away from the posterior surface of the lens capsule so that a distance between the intraocular lens and the lens capsule is greater than a threshold distance. Thereafter, at least a portion of the posterior surface of the lens capsule is removed.
Embodiments of the invention may include one or more of the following in any of a variety of combinations. The threshold distance may be approximately 10 μm, approximately 500 μm, or even approximately 3000 μm. Removing the at least a portion of the posterior surface of the lens capsule may include or consist essentially of focusing laser or ultrasound energy thereon. Urging the intraocular lens away from the posterior surface of the lens capsule may include or consist essentially of introducing a fluid (i.e., a liquid and/or a gas) between the intraocular lens and the posterior surface of the lens capsule. The viscosity of the fluid may be at least 1 centistoke, or even at least 1000 centistokes. The intraocular lens may include (i) a peripheral edge at least a portion of which is sealed against the lens capsule, and (ii) a posterior optical surface in opposed relation to the posterior surface of the lens capsule to form a compartment including both of the surfaces. The intraocular lens may be an inflatable intraocular lens. Urging the intraocular lens away from the posterior surface of the lens capsule may include or consist essentially of removing fluid (i.e., liquid and/or gas) from at least a portion (e.g., at least one of one or a plurality of compartments) of the intraocular lens.
In another aspect, embodiments of the invention feature an intraocular lens for implantation into a lens capsule of an eye. The intraocular lens includes or consists essentially of a lens portion for replacement of a natural lens of the eye, and a sealing portion configured to sealingly contact the lens capsule to form a sealed compartment between the intraocular lens and a posterior surface of the lens capsule. The sealing portion is disposed peripherally to the lens portion. The sealing portion may be pierceable and/or moveable to allow introduction of fluid between the intraocular lens and the posterior surface of the lens capsule.
In yet another aspect, embodiments of the invention feature a method of treatment of an eye comprising a lens capsule from which a natural lens has been removed. A perforation pattern is formed in a posterior surface of the lens capsule. The perforation pattern includes or consists essentially of (i) one or more perforations extending through at least a portion of a thickness of the lens capsule, and (ii) one or more intact areas proximate the one or more perforations. After formation of the perforation pattern, an intraocular lens is implanted within the lens capsule. After implantation of the intraocular lens, an aperture is formed within the posterior surface of the lens capsule by ablating at least one of the intact areas of the perforation pattern.
Embodiments of the invention may include one or more of the following in any of a variety of combinations. Forming the perforation pattern may include or consist essentially of cutting the posterior surface of the lens capsule mechanically and/or by application of energy to the posterior surface of the lens capsule. Prior to forming the aperture, at least a portion of the intraocular lens may be urged away from the posterior surface of the lens capsule. Urging the at least a portion of the intraocular lens away from the posterior surface of the lens capsule may include or consist essentially of introducing a fluid (i.e., a liquid and/or a gas) between the intraocular lens and the posterior surface of the lens capsule. Forming the aperture may include or consist essentially of urging at least a portion of the intraocular lens against at least one of the intact areas of the perforation pattern. The intraocular lens may include one or more fiducial markings thereon. Implanting the intraocular lens within the lens capsule may include or consist essentially of substantially aligning at least one fiducial marking with an intact area of the perforation pattern. At each fiducial marking, (i) a thickness of the intraocular lens may be greater than a thickness of the intraocular lens away from the fiducial marking, and/or (ii) a coating may be disposed on the intraocular lens. Ablating at least one of the intact areas of the perforation pattern may include or consist essentially of focusing laser or ultrasound energy through at least one of the fiducial markings
In another aspect, embodiments of the invention feature a method of treatment (i) of an eye comprising a lens capsule from which a natural lens has been removed, and (ii) using an intraocular lens (a) having one or more fiducial markings thereon and (b) implantable within the lens capsule with a desired alignment. A perforation pattern is formed in a posterior surface of the lens capsule. The perforation pattern includes or consists essentially of (i) one or more perforations extending through at least a portion of a thickness of the lens capsule, and (ii) one or more intact areas proximate the one or more perforations. After formation of the perforation pattern, an intraocular lens is implanted within the lens capsule with the desired alignment. At least a portion of the perforation pattern is substantially aligned with one or more of the fiducial markings on the intraocular lens. After implantation of the intraocular lens, an aperture is formed within the posterior surface of the lens capsule by ablating at least one of the intact areas of the perforation pattern.
Embodiments of the invention may include one or more of the following in any of a variety of combinations. Forming the perforation pattern may include or consist essentially of cutting the posterior surface of the lens capsule mechanically and/or by application of energy to the posterior surface of the lens capsule. Prior to forming the aperture, at least a portion of the intraocular lens may be urged away from the posterior surface of the lens capsule. Urging the at least a portion of the intraocular lens away from the posterior surface of the lens capsule may include or consist essentially of introducing a fluid (i.e., a liquid and/or a gas) between the intraocular lens and the posterior surface of the lens capsule. Forming the aperture may include or consist essentially of urging at least a portion of the intraocular lens against at least one of the intact areas of the perforation pattern. At each fiducial marking, (i) a thickness of the intraocular lens may be greater than a thickness of the intraocular lens away from the fiducial marking, and/or (ii) a coating may be disposed on the intraocular lens. Ablating at least one of the intact areas of the perforation pattern may include or consist essentially of focusing laser or ultrasound energy through at least one of the fiducial markings
In another aspect, embodiments of the invention feature an intraocular lens for implantation into a lens capsule of an eye. The intraocular lens includes or consists essentially of a lens portion for replacement of a natural lens of the eye, and one or more fiducial markings (e.g., disposed on or in the lens portion or peripherally to the lens portion) for alignment with a perforation pattern disposed within a posterior surface of the lens capsule. At each fiducial marking, (i) a thickness of the intraocular lens may be greater than a thickness of the intraocular lens away from the fiducial marking, and/or (ii) a coating may be disposed on the intraocular lens.
In yet another aspect, embodiments of the invention feature an ocular treatment system usable for the treatment or prevention of posterior capsule opacification of a patient's eye comprising a lens capsule in which an intraocular lens is implanted, the intraocular lens having (A) a peripheral edge at least a portion of which is sealed against the lens capsule, and (B) a posterior optical surface in opposed relation to a posterior surface of the lens capsule to form a compartment including both of the surfaces. The system includes or consists essentially of (i) an imaging system for acquiring images of features within the patient's eye, the features comprising the intraocular lens and a posterior surface of the lens capsule, (ii) a measurement unit for determining relative spacings between features imaged by the imaging system, (iii) a fluid actuation system for introducing fluid into the compartment, the fluid actuation system cooperating with the measurement unit to cause a distance between the posterior optical surface and the posterior surface of the lens capsule to exceed a threshold distance, and (iv) a removal system for removing at least a portion of the posterior surface of the lens capsule.
Embodiments of the invention may include one or more of the following in any of a variety of combinations. The system may include a guidance system for controlling the removal system based on, at least in part, spacings determined by the measurement unit. The guidance system may be configured to recognize fiducial markings on the intraocular lens and control the removal system on the basis thereof. The removal system may include or consist essentially of a mechanical cutter, a laser, an ultrasound system, and/or a fluid removal system.
In another aspect, embodiments of the invention feature a method of treating posterior capsule opacification (PCO) in a patient's eye comprising (i) a lens capsule having a posterior surface exhibiting PCO, and (ii) an intraocular lens implanted within the lens capsule, the intraocular lens having (A) a peripheral edge at least a portion of which is sealed against the lens capsule, and (B) a posterior optical surface in opposed relation to the posterior surface of the lens capsule to form a compartment including both of the surfaces. A liquid is infiltrated into the compartment to urge the intraocular lens away from the posterior surface of the lens capsule so as to increase a distance between the posterior optical surface and the posterior surface of the lens capsule so that it exceeds a threshold distance. Thereafter, at least a portion of the posterior surface of the lens capsule is removed.
Embodiments of the invention may include one or more of the following in any of a variety of combinations. The threshold distance may be approximately 10 μm, approximately 500 μm, or even approximately 3000 μm. Removing the at least a portion of the posterior surface of the lens capsule may include or consist essentially of focusing laser or ultrasound energy thereon. The viscosity of the liquid may be at least 1 centistoke, or even at least 1000 centistokes.
In another aspect, embodiments of the invention feature a method of treating posterior capsule opacification (PCO) in a patient's eye comprising (i) a lens capsule having a posterior surface exhibiting PCO, and (ii) an intraocular lens implanted within the lens capsule. The intraocular lens away is urged from the posterior surface of the lens capsule so that a distance between the intraocular lens and the lens capsule is greater than a threshold distance. Thereafter, at least a portion of the posterior surface of the lens capsule is removed. Urging the intraocular lens away from the posterior surface of the lens capsule may include or consist essentially of infiltrating a liquid into the compartment. The intraocular lens may be an inflatable intraocular lens. Urging the intraocular lens away from the posterior surface of the lens capsule may include or consist essentially of removing fluid from at least a portion of the intraocular lens.
These and other objects, along with advantages and features of the present invention herein disclosed, will become more apparent through reference to the following description, the accompanying drawings, and the claims. Furthermore, it is to be understood that the features of the various embodiments described herein are not mutually exclusive and may exist in various combinations and permutations. As used herein, the terms “approximately” and “substantially” mean ±10%, and in some embodiments, ±5%. The term “consists essentially of” means excluding other materials that contribute to function, unless otherwise defined herein. Nonetheless, such other materials may be present, collectively or individually, in trace amounts.
In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. In the following description, various embodiments of the present invention are described with reference to the following drawings, in which:
Embodiments of the present invention feature PCO treatments in which the IOL and the posterior lens capsule are spaced apart prior to removing the posterior lens capsule. Refer to
As shown in
In various embodiments of the invention, IOL 200 includes, corresponds to, or consists essentially of a fluid-filled IOL (i.e., an IOL including or consisting essentially of one or more compartments that may be filled, emptied, and refilled with a liquid for adjusting the fit and/or accommodative power of the IOL). Filling the fluid-filled IOL 200 creates a conformal fit between lens capsule 110 and lens 200. This conformal fit provides a partially or completely sealed compartment 210 to temporarily allow injection of fluid 215 between the lens capsule 110 and IOL 200. When the fluid 215 is stable or of sufficient viscosity, the fluid will remain within compartment 210 for an extended period of time. After implantation of IOL 200 and injection of fluid 215, the surgical case may be closed and the patient released. The posterior lens capsule may be opened either at the time of surgery (e.g., intraoperative), immediately after surgery, or at a later date.
Fluid 215 may remain in compartment 210 for a prolonged period of time, thereby allowing the opening of the posterior lens capsule to be performed well after the introduction of fluid 215. The total amount fluid 215 that remains in the posterior lens capsule depends on the initial amount of fluid injected, the viscosity of the fluid, the amount of sealing provided by sealing portion 205, and the ability of the fluid to diffuse through the posterior lens capsule. If it is assumed that no fluid travels through the body of IOL 200, the total amount of fluid may be estimated with the following equation:
Fluid (t)=Fluidi−t(diffusion rate+leakage rate),
where Fluid(t) is the total amount of fluid in compartment 210, t is time, Fluidi is the initial amount of fluid, diffusion rate is the rate of diffusion through the posterior lens capsule, and leakage rate is the rate of leakage through sealing portion 205.
The diffusion rate depends on the lens capsule thickness, permeability, and diffusion constant of fluid 215. The leakage rate through the sealing portion 205 depends on the pressure gradient between compartment 210 and the surrounding aqueous humor, the size of fluid path through sealing portion 205, and the viscosity of fluid 215. If a circular channel is formed, causing fluid to flow out, assuming laminar flow, the flow rate through the channel may be approximated using the Hagen-Poiseuille flow:
where P is the pressure of fluid 215 relative to the surrounding aqueous, d is the diameter of the fluid path, L is the length of the fluid path, and μ is the dynamic viscosity of the fluid. Thus, higher viscosity fluids flow at a slower rate through any leakage path. In addition, in embodiments in which there is perfect sealing via sealing portion 205, then leakage depends only on diffusion.
When sealing is very good via sealing portion 205, fluid 215 may remain in compartment 210 for extended periods of time. Fluid has been demonstrated to remain in compartment 210 for more than one day, and in certain cases more than one week, and even longer than one month with appropriate sealing of a liquid-filled IOL. Sealing is often better when a fluid-filled IOL is used, as the filling amount may be tailored to the individual lens capsule 110.
In various embodiments of the invention, the fluid 215 may also be selected for its energy-dissipation properties to prevent any pockets of high energy (e.g., high temperature) caused by, e.g., laser energy. Alternatively, fluids 215 that resist cavitation may be selected if an ultrasound cutting tool is to be utilized; thus, any cavitation of the fluid will be minimal and will not damage the IOL 200 if spaced a sufficient distance.
As mentioned above, an appropriate spacing between the lens capsule 110 and the IOL 200 enables the targeting of the posterior lens capsule without damaging IOL 200. Because in various embodiments the spacing is related to the amount of fluid 215 in compartment 210, the surgical timeframe to remove the posterior lens capsule may be determined, at least in part, by the stability of the fluid 215 in compartment 210. For example, if an adequate amount of fluid 215 remains for 12 months, then the surgeon may implant the IOL and place fluid 215 in compartment 210, and the posterior lens capsule may be opened any time from the implantation period up to 12 months later.
Fluid stability may also be important when cutting an aperture in lens capsule 110. The cutting forms an opening 225, from which fluid 215 may leak out of compartment 210 while the remainder of the cutting occurs. This leakage loss of fluid 215 through opening 225 depends on the size of the hole as it is cut, pressure differential between compartment 210 and surrounding fluid, and the viscosity and cohesiveness of the filling fluid 215. Therefore, when the aperture through the posterior lens capsule is formed (via, e.g., application of laser energy), a viscous fluid 215 with a low pressure may be utilized in various embodiments of the invention, thereby enabling a slow release of the fluid 215 from compartment 210 to the surrounding environment. Slow release allows opening of the lens capsule while maintaining the integrity of the compartment 210. If a low-viscosity fluid is used, compartment 210 may collapse as the lens capsule is opened via a rapid efflux of fluid 215. Thus, in various embodiments, the viscosity of fluid 215 is nominally approximately 1 centistoke or higher, or even approximately 100 centistokes or higher. When a fluid 215 including or consisting essentially of viscoelastic is used, viscosity is often higher than 10,000 centistokes. In various embodiments, the viscosity of fluid 215 is less than approximately 700,000 centistokes. The viscosity of fluid 215 may be selected by, e.g., selecting one or combining two or more fluids such as viscoelastics, and/or by altering primarily glucose concentration and/or any protein or polypeptide composition of the fluid 215. In addition, fluid 215 should be safe to the surrounding ocular structures and preferentially absorbable by the surrounding ocular structures. In various embodiments, the fluid 215 is clear and of a similar refractive index to the aqueous humor of the eye, thus preventing any visual disturbances that may occur from the fluid 215 being inside the eye.
For clarity, an example of the above-described technique is presented. First, a compartment 210 between the posterior part of the IOL and the posterior capsule is created either at the time of IOL implantation or at a later date. The separation between the IOL and the posterior capsule may be created by injection of any fluid (e.g., water, balanced salt solution, ringer lactate, viscoelastic (e.g., sodium hyaluronate, chondroitin sulfate, and/or hydroxypropyl methycellulose), or others) or any type of gas. The fluid may either be transparent or dyed with a biocompatible solution (i.e.; steroids, trypan blue, indocyanine green). The injection of the fluid may be performed using a needle, a blunt needle, and/or a tool that provides continuous irrigation. The infusion of fluid may be provided by, for example, an infusion pump or from a bottle of balanced salt solution attached to a pole. Next, the IOL is moved anteriorly or to the side. This may be performed mechanically with a surgical instrument, injection of a fluid, or in embodiments using a fluid-filled lens, by partially or completely deflating the IOL. (For example, a fluid-filled IOL may be deflated with a tool that can aspirate the fluid through a line and/or needle. Such a system may also contain an infusion system that keeps the anterior chamber of the eye pressurized. This deflation moves the IOL out of the 3 mm center of the posterior capsule in a fashion to facilitate the laser.) Next, a laser source (Nd:YAG laser, diode laser, argon laser, excimer laser, femtosecond laser or others) or ultrasound source (ultra-high frequency) is used to rupture the posterior capsule. In cases in which the laser is not sufficient to create a rupture of the posterior capsule, an additional mechanical force such as injection of gas or liquid may be applied to cause the rupture of the posterior capsule. Finally, the IOL is re-inflated (if necessary). A sealing portion of the IOL may be used to interact with the posterior lens capsule. This system may additionally contain an aspiration feature to remove the fluid used to separate the IOL and posterior capsule (thus forming compartment 210) either during or after the rupturing of the posterior capsule. The aspiration feature may additionally remove any tissue removed during the PCO treatment.
In other embodiments of the present invention, a fluid-filled (or otherwise inflatable) IOL 200 may simply be partially or fully deflated (i.e., exhausted of fluid from one or more internal compartments) before the posterior lens capsule is opened. As shown in
As mentioned above, in various embodiments of the present invention, a perforation pattern (i.e., one or more openings, cuts, or perforations) may be cut or otherwise introduced into the posterior portion of the lens capsule in order to facilitate later removal thereof. While the perforation pattern is typically introduced prior to implantation of an IOL, the perforation pattern may also be introduced after implantation of the IOL (e.g., after partial or complete deflation of a fluid-filled IOL to move the IOL out of the path of the cutting implement). In various embodiments, the perforation pattern is introduced before removal of the natural lens in cataract surgery, or immediately thereafter (i.e., during the same surgical procedure or one immediately following the cataract removal).
As shown in
As shown in
In various embodiments, an IOL contains markings (e.g., fiduciary markings) therein or thereon that align with features of a perforated pattern cut into a posterior lens capsule. (Equivalently, a perforated pattern may be cut into a posterior lens capsule, where the pattern is aligned with markings on an IOL to be implanted into the lens capsule.) The markings may additionally be used for correct placement of the IOL to achieve desired visual acuity (e.g., toric features that require a particular rotational alignment). As shown in
In accordance with various embodiments of the invention, apertures may be cut into posterior lens capsules via the use of an optically guided ablation system such as a laser. In various embodiments, the optically guided system is integrated with, or a portion of, an imaging system such as a microscope or an optical coherence tomography (OCT) system, and in other embodiments the optically guided system is a separate unit that interfaces with an imaging system. For example,
In accordance with embodiments of the invention, the system 700 only targets areas of a posterior lens capsule for ablation if (1) they are indicated by markings on an IOL, and/or (2) the spacing between such areas of the posterior lens capsule and the IOL are greater than a threshold, thereby ensuring that the IOL is not damaged during ablation of the posterior lens capsule. For example, the threshold spacing between a region of an IOL and an area of a posterior lens capsule may be approximately 10 μm, approximately 500 μm, or even approximately 3000 μm.
The system 700 may also incorporate a fluid actuation system 712 to control the introduction of fluid between the IOL and the posterior lens capsule, thereby increasing the spacing between the IOL and the posterior lens capsule as detailed herein. The fluid actuation system 712 may include or consist essentially of, for example, a syringe, and the amount of fluid introduced behind the IOL may be monitored and controlled in real time via feedback from the imaging system 710 and the resultant spacing measured by unit 705. Fluid actuation system 712 may also be utilized to remove fluid from behind the IOL, if desired. As shown, the fluid actuation system 712 is typically connected to, or incorporates within, one or more fluid reservoirs 713 that contain the fluid to be introduced into the eye and/or into the IOL. The fluid actuation system 712 may additionally be connected to a waste reservoir 714 that is utilized to contain the fluid and other material (e.g., pieces of the posterior capsule and/or large masses of epithelial cells) removed from the IOL or eye.
As shown, the system 700 may also incorporate an ablation or cutting or removal tool 715 (e.g., a laser, ultrasound unit, mechanical cutting apparatus, etc.) for ablation or cutting or removal of portions of the posterior lens capsule identified by the unit 705. The removal tool 715 may be integrated with the imaging system 710. The system 700 may also incorporate a guidance unit 720 that provides guidance (e.g., automated guidance) of the removal tool 715 and/or the imaging system 710 based on the data acquired by the unit 705. In various embodiments, the guidance unit 720 may guide the removal tool 715 and/or the imaging system 710 based on one or more maps created by unit 705 based on the imaged data. Such maps may indicate, for example, one or more regions of a posterior lens capsule that are sufficiently spaced away from an implanted IOL such that ablation of the capsule portions will not damage the IOL.
In particular, as shown in
Any suitable programming language may be used to implement without undue experimentation the analytical functions described above. Illustratively, the programming language used may include assembly language, Ada, APL, Basic, C, C++, C*, COBOL, dBase, Forth, FORTRAN, Java, Modula-2, Pascal, Prolog, Python, REXX, and/or JavaScript for example. Further, it is not necessary that a single type of instruction or programming language be utilized in conjunction with the operation of the system and methods of embodiments of the invention. Rather, any number of different programming languages may be utilized as is necessary or desirable.
The computing environment may also include other removable/nonremovable, volatile/nonvolatile computer storage media. For example, a hard disk drive may read or write to nonremovable, nonvolatile magnetic media. A magnetic disk drive may read from or writes to a removable, nonvolatile magnetic disk, and an optical disk drive may read from or write to a removable, nonvolatile optical disk such as a CD-ROM or other optical media.
The processor that executes commands and instructions may be a general-purpose processor, but may utilize any of a wide variety of other technologies including special-purpose hardware, a microcomputer, mini-computer, mainframe computer, programmed micro-processor, micro-controller, peripheral integrated circuit element, a CSIC (Customer Specific Integrated Circuit), ASIC (Application Specific Integrated Circuit), a logic circuit, a digital signal processor, a programmable logic device such as an FPGA (Field Programmable Gate Array), PLD (Programmable Logic Device), PLA (Programmable Logic Array), RFID processor, smart chip, or any other device or arrangement of devices that is capable of implementing the steps of the processes of embodiments of the invention.
The terms and expressions employed herein are used as terms and expressions of description and not of limitation, and there is no intention, in the use of such terms and expressions, of excluding any equivalents of the features shown and described or portions thereof. In addition, having described certain embodiments of the invention, it will be apparent to those of ordinary skill in the art that other embodiments incorporating the concepts disclosed herein may be used without departing from the spirit and scope of the invention. Accordingly, the described embodiments are to be considered in all respects as only illustrative and not restrictive.
This application claims the benefit of and priority to U.S. Provisional Patent Application No. 62/056,950, filed Sep. 29, 2014, and U.S. Provisional Patent Application No. 62/066,134, filed Oct. 20, 2014, the entire disclosure of each of which is hereby incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62056950 | Sep 2014 | US | |
| 62066134 | Oct 2014 | US |
