# Patent

## Title
Apparatus for the treatment of cataract

## Abstract

An apparatus to treat a cataract where the cataractous lens is pierced and the resulting opening is mechanically maintained using a lens system device such as a cylindrical lens, tubular lens, pinhole device, a stent or similar small diameter device, or where the device itself is the lens. The resulting passageway for visible light created in the cataractous lens allows light to better reach the retina, thus improving vision. This lens system device that can be placed into an in situ cataract provides for a much simpler surgical technique and reduces related pre and post operative procedures and potential complications. Intraocular lenses may also be used in concert with this invention. The apparatus and related methods can be applied to humans as well as animals.

## Background
CROSS REFERENCE TO RELATED PATENT APPLICATIONS
This application is a continuation-in-part of U.S. patent application Ser. No. 14/181,559 filed Feb. 14, 2014 entitled “Apparatus And Method For The Treatment of Cataract” by Dr. David M. Kleinman of Rochester, N.Y., which is a continuation of U.S. patent application Ser. No. 13/691,810 filed Dec. 2, 2012 entitled “Method For The Treatment of Cataract” by Dr. David M. Kleinman of Rochester, N.Y., which is a divisional of U.S. patent application Ser. No. 12/581,152 filed Oct. 18, 2009 entitled “Apparatus and Method For The Treatment of Cataract” by Dr. David M. Kleinman of Rochester, N.Y., which claims priority to U.S. Patent Application Ser. No. 61/106,876 filed Oct. 20, 2008 entitled “Apparatus and Method For The Treatment of Cataract” by Dr. David M. Kleinman of Rochester, N.Y.


BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates generally to surgery of the eye, and more particularly to an apparatus for the treatment of cataract.
2. Description of Related Art
Cataract is the leading cause of blindness in the world. There are currently over 100 million people in the world that have cataracts that interfere with visual function. In addition, there are currently approximately 22 million people in the world who are completely blind from cataracts. The vast majority of these patients live in developing countries. Despite modern surgical techniques, the rate of cataract blind increases annually. The prevalence of bilateral cataract blind is currently increasing by 1.5 million people per year. There are seven million cataract surgeries performed annually, but the fact that ophthalmologists cannot remove the backlog of bilateral cataract blind or even keep up with the rates of new cataracts generally is clear evidence that a new methodology to deal with developing world cataracts is required.
Pediatric cataract is a devastating problem world wide, and its treatment is very challenging. The disability and economic burden on families, communities, and countries based on the combination of pediatric and adult cataract is staggering.
Cataracts are an opacification of the natural human lens. Current methods of cataract treatment include removal of the lens, and refractive correction. Oftentimes, an intraocular lens is used. Historically, the lens could be couched with a needle. There are no pharmacological treatments for cataract blind. It is purely a surgical disease. Extracapsular cataract extraction is a very effective method for treating cataract blind. Once the cataractous lens is removed, more light will enter the eye; however, a method to focus the light (except in the rare case of very high myopes) is required. Either spectacles or a precise and calculated power of intraocular lens is required. To choose the correct power intraocular lens, biometry and keratometry are required. These technologies are often not available in the developing world, and as a consequence, standard powered lenses are implanted in the hope that most people will see substantially better.
The current invention not only describes a novel apparatus and method for treating millions of individuals blind from cataract, and in some embodiments also reduces the need for precise refractive correction after cataract treatment.
It is thus an object of the present invention to provide an apparatus for treating cataract that can be performed in locations without extensive cataract treatment support infrastructure. It is another object of the present invention to provide an apparatus for treating cataract that can be performed in locations with fewer specialized practitioners. It is another object of the present invention to provide an apparatus to treat cataract. It is another object of the present invention to provide an apparatus to assist with a novel method of treating cataract. It is yet another object of the present invention to provide an apparatus that comprises a cylindrical lens for the treatment of cataract.
BRIEF SUMMARY OF THE INVENTION
In accordance with the present invention, there is provided a cylindrical lens for in situ placement in a cataractous lens of an eye of a patient, the cylindrical lens comprising a generally cylindrical shape having a cylindrical axis; an expandable material capable of increasing its volume upon implantation in a cataractous lens of an eye of a patient; a lens contained within the cylindrical shape to allow for the passage of light; wherein the cylindrical lens is capable of traversing a surgical tool along the cylindrical axis of the cylindrical lens while maintaining its generally cylindrical shape after exit of the surgical tool; and wherein the cylindrical lens is capable of being implanted in the cataractous lens of an eye of a patient with the cylindrical axis of the cylindrical lens generally perpendicular to a surface of the cataractous lens.
The foregoing paragraph has been provided by way of introduction, and is not intended to limit the scope of the invention and its various embodiments described, depicted, or envisioned herein.



BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be described by reference to the following drawings, in which like numerals refer to like elements, and in which:
FIG. 1 depicts a surgical tool for the treatment of cataract;
FIG. 2 depicts a surgical tool for the treatment of cataract with a guide wire disposed within and through the surgical tool;
FIG. 3 depicts a surgical tool for the treatment of cataract with a guide wire and lens system device installed;
FIG. 4 is a cross sectional view of an eye showing the surgical incision:
FIG. 5 is a cross sectional view of an eye showing the surgical tool entering the incision;
FIG. 6 is a cross sectional view of an eye showing the surgical tool being rotated into position;
FIG. 7 is a cross sectional view of an eye showing the surgical tool in position;
FIG. 8 is a cross sectional view of an eye showing the guide wire being deployed;
FIG. 9 is a cross sectional view of an eye showing the lens system device being deployed;
FIG. 10 is a cross sectional view of an eye showing the lens system device in position;
FIG. 11 is a cross sectional view of an eye showing the lens system device expanded;
FIG. 12 is a cross sectional view of an eye showing the lens system device in place with the guide wire removed:
FIG. 13 is a cross sectional view of an eye showing a second embodiment of the lens system device in place with the guide wire removed;
FIG. 14 is a perspective view of a surgical tool in accordance with a second embodiment of the present invention;
FIG. 15 is a rotated perspective view of the surgical tool depicted in FIG. 14;
FIG. 16 is a plan view of the surgical tool of FIG. 14 showing the opening for deployment of a cylindrical lens of the present invention;
FIG. 17 is a cross sectional view of the surgical tool of FIG. 14 taken along line B-B of FIG. 16;
FIG. 18A is a cross sectional view of an eye showing the cylindrical lens in position;
FIG. 181 is a cross sectional view of an eye showing the cylindrical lens in an expanded state;
FIG. 19A depicts the cylindrical lens of the present invention in an unexpanded state;
FIG. 19B depicts the cylindrical lens of the present invention in an expanded state;
FIG. 20 depicts the cylindrical lens of the present invention with an exterior coating; and
FIG. 21 depicts an alternate embodiment of the cylindrical lens having a taper.



The present invention will be described in connection with a preferred embodiment, however, it will be understood that there is no intent to limit the invention to the embodiment described. On the contrary, the intent is to cover all alternatives, modifications, and equivalents as may be included within the spirit and scope of the invention as defined by this specification, claims, and the attached drawings.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
For a general understanding of the present invention, reference is made to the drawings. In the drawings, like reference numerals have been used throughout to designate identical elements.
The present invention and the various embodiments described or suggested herein rely on a surgical technique where the natural lens of the eye is pierced and the resulting opening is mechanically retained using a device that operates in ways that may be similar to cardiovascular stenting technologies. The resulting passageway, lumen, optical lumen or lens system created in the natural or cataractous lens allows light to reach the retina, thus improving vision. The resulting passageway through the natural lens is made through a diameter less than the diameter of the natural lens. The use of this lens system device with or without the pinhole principle provides for a much simpler surgical technique and reduces related pre and post operative procedures.
The apparatus and method of the present invention may involve human cases, and also may be critically important in pediatric cases, as light will be in focus on the retina, reducing the need for complex cataract surgery followed by contact lenses or glasses in infants, and thus also may play a role in preventing amblyopia. In addition, veterinary cases of cataract such as those which develop in dogs, cats, horses, and the like, may benefit from the apparatus and method of the present invention and the various embodiments described or envisioned herein.
Turning now to the drawings, both an exemplary surgical device, as well as related devices and methods, will be described using the drawings attached herein.
In FIG. 1, a surgical tool for the treatment of cataract is depicted. The surgical tool 100, in one embodiment, is essentially a hollow tube such as a cannula or related structure made from stainless steel, titanium, plastics, biocompatible polymers, or other material that is used to fabricate surgical instruments. The surgical tool 100 contains an angle 101. The angle is used to facilitate the method of the present invention, as will be further described herein. The angle may be ninety (90) degrees, as depicted in FIG. 1, or it may be within approximately sixty (60) degrees greater or less than ninety (90) degrees. The surgical tool 100 may, in some embodiments of the present invention, contain a sharp edge or other incision or cutting tool, such as, for example, a trocar, to assist with the method of the present invention. The sharp tool would be located at 102.
FIG. 2 further depicts the surgical tool 100 with a guiding structure 201 disposed within the surgical tool 100. The guiding structure, or guide wire in this example 201 must be capable of traveling through the angle 101 or conveying force through the angle, and must be of sufficient rigidity to support the piercing of the natural lens with its related cataract. Materials for the guide wire may include stainless steel, titanium, Kevlar, encapsulated glass (fiber optic material, and the like. Materials for the guiding structure may include metals, plastics, polymers, and the like. The guiding structure term is nomenclature that may include, but is not limited to, a guiding or lens system advancing structure, and also serves to reference a system that would deploy through the cannula for the purpose of piercing the cataractous lens allowing for the placement of the lens system device or stent or second permanent hollow cannula, lens, or lens system device that remains in the lens, or the guiding structure may be integral to, part of, or built into the surgical tool. The guiding structure may be one and the same as the surgical tool in some embodiments. The guiding structure may also refer to a method for advancing the lens system device into the cataractous lens. Heat, ultrasound, laser, or other electromechanical processes may be deployed at the tip to ease the penetration of the system through the lens. The material or part of it, such as, for example, the leading or trailing ends, may also be biodegradable material such as Polyglycolic acid polymers.
In FIG. 3 a lens system device 301, such as, for example a stent, is depicted within the surgical tool 100. The stent may be similar in structure and concept to a cardiac stent, but will be dimensioned to accommodate the procedure described herein. The lens system device 301 is a tubular sleeve capable of expansion. An example of a cardiac stent is disclosed in U.S. Pat. No. 7,435,255 to Rao entitled “Drug Eluting Stent and Methods of Making”, the entire disclosure of which, and the references cited therein, are incorporated in their entirety herein. The lens system device 301 may be fabricated from a metallic material such as stainless steel, platinum, titanium, tantalum, nickel-titanium, cobalt-chromium, and alloys thereof. In addition, the lens system device 301 may further contain drugs that are carried in a polymeric coating or sleeve that may or may not be loaded with at least one therapeutic drug. Suitable polymers for the lens system device, with or without drug loading include, for example, poly(methyl methacrylate) (“PMMA”), poly(ethylene-co-vinyl alcohol (“EVAL”), poly(butyl methacrylate) (“PBMA”), polyglycolic acid (“PGA”), poly(L-lactic acid) (“PLLA”), woven polymers, silicones, hydrogels, copolymers and blends thereof, as well as various nanomaterials such as carbon nanotubes and the like, or other polymers used for biocompatible coatings, linings, or with drug delivery capabilities familiar to those skilled in the art. The lens system device may also be made from a hydrophilic material that expands upon placement in an aqueous environment such as an eye. Suitable hydrophilic materials may include, but are not limited to, poly(2-Hydroxyethylmethacrylate) (pHEMA), hydroxyethyl methacrylate (HEMA), hydrophilic acrylic, hydrogels, hydrophilic polymers, fluorocarbon-sulfone. Thus, a dehydrated transparent hydrophilic polymer would expand over time once placed in position through the cataract. Also depicted in FIG. 3 is a taper 303 that is an integral part of, or a detachable part of, the lens system device 301. The taper 303 allows the lens system device 301 to travel and insert into the created lumen in the natural lens. This aspect to the device may also be capable of transmitting heat, ultrasound, laser, or other electromechanical energies to ease placement through the cataractous lens. The taper 303 may be present in some embodiments of the present invention, and may be absent from the lens system device 301 in other embodiments of the present invention. The taper may, in some embodiments of the present invention, may be biodegradable, or threaded. In some embodiments of the present invention, the lens system device 301 may be surrounded by a component that would prevent lens material from entering the patent space opened by the stent or lens system device. The component that surrounds the lens system device to keep the lens material out could be made from DACRON® (polyethylene terephthalate fibers), GORE-TEX® (expanded polytetrafluoroethylene), Nylon, or other biodegradable or non-biodegradable materials. This outer coating, or the entire lens system device could be made from intraocular lens material such as acrylic, PMMA, or silicon. There also may be an intraocular lens contained in the lens system device, or deployed into it in an additional step. The diameter of this lens system device would range from less than 1 mm (0.19 mm minimum) up to 5 mm after expansion. The lens system device may be completely embedded in or surrounded by the intraocular lens material or polymer that keeps lens material out of the patent space through the lens. The lens system device may contain a tubular, expandable, foldable or non foldable IOL or synthetic lens material in its center. The lens power would range from −50 to +50 diopters, but would, in one embodiment be +16 to +20 diopters. The lens system device may expand to 4 mm in one embodiment, but could function with diameters of between 2 and 5 mm. The lens system device or stent may expand to 4 mm in one embodiment, but contain in the midpoint, a metal plate with a smaller opening (pinhole) in the range from 0.10 mm to 3 mm. In one embodiment, an opaque covering is placed with the lens system device that extends outside the anterior opening for 360 degrees around reaching a diameter up to 8 mm but it could be as little as 1 mm wider than the central opening.
In use, the cataractous lens of a patient is pierced directly in the visual axis with a sturdy material or device such as a wire, for example the guide wire 201, with or without an accompanying flexible or rigid catheter, and a small stent or other small or medium sized diameter device is placed in the defect created. In one embodiment the cylindrical lens can be advanced directly through the insertion instrument and can be used to pierce the cataractous in situ lens directly. There may be a pointed tip on or as part of the distal end of the cylindrical lens to aid such piercing of the cataract. The tip may be a separate piece placed adjacent to the cylindrical lens. Laser or other types of energy may be imparted into the system either through the cylindrical lens during its advancement through the tool and eye or at a step prior to the point the cylindrical lens pierces the cataract. The energy source may be internal (applied through the instrumentation) or external in that it is applied either through the cornea or through a separate instrument or step. This energy will create, soften the lens, or otherwise help create space for the implant such that it can be advanced and placed with minimal trauma to the supporting structures of the cataractous lens (capsule and zonules). The guiding system for the lens may be a fiberoptic, fiberoptic cable or contain a fiberoptic or fiberoptic cable. The new space created in the cataractous lens is maintained by a device such as a metal stent (titanium or other metals), or plastics (silicones, hydrogels or PMMA or others), or a lens system device or cylindrical lens or tubular lens or other biocompatible material. The stent or lens system device may be surrounded by a biocompatible shell such as Dacron®, Gore-Tex®, acrylic, PMMA, silicone or any non absorbable or absorbable or biodegradable material to maintain the patency of the newly created opening and to ensure lens material does not enter into the full thickness hole in the lens (especially in the case of wire stents, but other scenarios as well. Polymer coatings may be hydrophilic or hydrophobic. The diameter of the passageway or lumen or opening is typically 1.5 mm. to 3.5 mm., but it can be smaller or larger. The tight fit of the lens system device 301, stent, lumen maintainer, tubular lens, or pinhole device adjacent to the anterior or posterior capsule will prevent dissipation of lens material into the anterior or posterior segments; the lens capsule will be snug against the device. This procedure will not prevent traditional types of cataract extraction in the future. Light will go through the small aperture, lens system device, cylindrical lens, expandable cylindrical lens, tubular lens, expandable tubular lens, tubular lens made from hydrogel polymers, or in some embodiments a pinhole, and focus on the retina, because of A) refractive correction by the patient, B) an intraocular lens in the system, C) the pinhole principal regardless of the refractive error of the eye, or D) the focus may be suboptimal, but the vision provided will be superior to the vision with the cataract in place. In one embodiment, the vision will essentially be aphakic quality. In this scenario, there may be an opening, passageway, or lumen between 3 and 5 mm in diameter through the cataract. A secondary anterior chamber, or intraluminal lens may also be placed either in front of or inside the lumen to correct refractive error. The method involves entering the peripheral cornea, opening through the lens a significant passageway for light, and maintaining its patency with a specially designed device such as the lens system device 301. The lens system device could be of polymeric construction, for example, PMMA, silicone, or acrylic construction, hydrogel construction, or titanium or other metals or other polymers or combinations thereof, possibly including other materials that are used to treat cataracts or manufacture stents or intraocular lenses. To gently pierce the cataract, a mechanized system may be required, such as using ultrasound energy, laser, heat, or other mechanical means to allow the passage of the guiding system and or stent through the cataract. In one embodiment, a supporting instrument may be passed through the pars plana to stabilize the lens for the procedure. Methods for stabilizing the lens when the surgical tool and/or guiding structure is detached from the lens system device or stent or removed from the eye are included as embodiments of the present invention and may include mechanical or other methods of release systems. Other embodiments of the present invention use a screw type technology to pierce and drive a guiding structure (with or without an accompanying flexible or rigid catheter, stent, balloon, or expandable lens system) or other structure through a cataractous lens in a human or animal eye to create a clear space or tunnel for light to pass through to preserve or improve sight. In one embodiment the lens system device or stent will be flexible enough to make the turn through angle 101 in FIG. 1. In one embodiment, the rigidity of the stent is supplied by rings or spiral material inside the stent. The use of this technology is applicable and useful in human or animal lenses of any density and brunescence or any type of cataract including but not limited to congenital, acquired, traumatic, nuclear, polar, cortical, posterior subcapsular, infectious, post operative, inflammatory. In the case of some cataracts penetration of the lens material will be easier (pediatric or traumatic cataract) or more difficult (calcific, senile, or brunescent cataract). The system may be tunable so that less energy is used to penetrate one type of cataract versus another. In one embodiment of the present invention, a mechanized system is employed that imparts rotational energy to the guiding structure, stent components (all with or without threads), or both during the procedure to ease their passage into and through the cataractous lens. In other embodiments, electrical, electrocautery, thermal, laser, ionization, chemical, nuclear, or ultrasonic energy is used to aid in the penetration of the cataractous lens and/or for the placement of the stent or lens system device that is integral to this invention.
FIGS. 4 through 13 provide examples of the steps involved in the methods of the present invention, and also provide examples of how to use the surgical tool and related implantable device of the present invention. The examples provided in the figures are not to be construed as limitations of the present invention and its various embodiments described herein, but rather, are depicted to fully allow one skilled in the art to make and use the invention along with modifications, adaptations, and alterations, all being within the spirit and broad scope of the present invention as fully defined herein. FIGS. 4 through 13 depict a human eye, but the methods and apparatus of the present invention are equally well adapted to veterinary medicine.
In FIG. 4, an eye 400 is depicted. An incision 401 is made in the cornea, the diameter of the incision through the cornea can be between 0.25 mm. and 2 mm., being self sealing, but may be up to 6 mm., and may require surgical closure. In some embodiments of the present invention, a support structure or support structures 403 may be used to hold the lens in place during surgery. In some embodiments of the present invention, a polymer block is used that rests externally on the eye to stabilize it so that when the guiding structure and/or surgical tool (with or without an accompanying flexible or rigid catheter) and other related technologies are entered into the cornea, the eye is held steady to minimize the risk of injury through movement. Viscoelastic, or other viscous materials may be injected into the anterior chamber (and left in place or washed out) during the procedure to maintain the anterior chamber. Alternatively, a simple anterior chamber maintainer such as a needle or Lewicky cannula may be used to maintain the anterior chamber. The goal of the surgery is to place a hole and support structure (such as but not limited to a stent, lens system device, cylindrical lens, expandable cylindrical lens, tubular lens, IOL, or lumen maintainer) through the cataractous lens 407, thus allowing light to enter the back of the eye to the retina, improving vision.
FIG. 5 now depicts the surgical tool 100 entering the incision 401 in a linear direction of travel 501, as depicted by way of 501. Note that the surgical tool 100 is placed in such a way as to clear any and all obstructions. Once the surgical tool 100 is in a position where the guiding structure or guide wire (not shown in FIG. 6) may be directed toward the visual axis and center of the lens, the surgical tool 100 is rotated in a rotational direction of travel 601 such that a pinhole and related lens system device deployment may be made. FIG. 7 shows the surgical tool in the proper position after rotation.
In FIG. 8, a guide wire or guiding apparatus 201 or similar rigid structure is inserted in the hollow of the surgical tool 100, passed through the hollow of the surgical tool 100, and allowed to exit the surgical tool 100 in such as a way as to create a pinhole, track, passageway or lumen through the lens. The guide wire or guiding structure 201 may include plastics, balloons, flexible wires, catheters, needles, hollow pipes, fiberoptic cables, rotational drills, ultrasound, electrocautery, lasers including femtosecond, continuous wavelength, ND YAG, and other methods to generate heat or other types of energy to pierce the anterior lens capsule and then the entire lens to create the opening through that lens. Any or all of these techniques may also be used to create a space for insertion of a guide wire and with or without similar methods for the passage of the ultimate cannula, stent, lens system (expandable lens in some embodiments) that eventually maintains the patent opening through the cataract. In some embodiments of the present invention, a fiberoptic cable or strand may be used to maintain patency of the opening, and, in some embodiments of the present invention, may be used to bypass a cataract. In some embodiments of the invention the lens device system or stent is passed over the guiding structure into the lens for its deployment, in other embodiments, the guiding structure and or guide wire may be passed into the lens simultaneously with the lens device system or stent, such that the guiding apparatus essentially allows for the positioning, deployment, and eventual release of the lens device system, expandable intraocular lens, stent, or lumen creation device. The guiding apparatus can be part of, or one in the same, as the surgical tool itself.
In FIG. 9, once the initial hole, passageway lumen or small tunnel is created in the lens, a stent assembly, or lens system 901 or similar structure is conveyed to or through the smaller lumen along the wire using guiding techniques such as guiding structures and the like. Or, the guiding structure could simply advance the lens or stent system primarily into the cataractous lens so it can be deployed. This guiding structure 201 may also consist of release mechanisms such as a double barrel design whereby the inner guiding structure is used to advance the lens piercing and/or lens device system into the cataract, and the outer portion is able to place counter traction on the lens device system, stent, or lumen such that the guiding structure can be removed, pulled away, and/or separated from the lens device system, stent, or lumen, and the in situ cataract without dislocating or otherwise destabilizing the new integrated relationship between cataract and lens device system, stent or lumen. Release mechanisms different from the double barrel design are other embodiments of this invention. Such release systems would allow for the separation of the guiding structure and lens device structure via severing the guiding structure from the stent or lens device system anteriorly or proximal to the lens device system or stent. Methods to accomplish this separation include but are not limited to a triggered release system activated mechanically through, for example, a fine wire, or though a micromachine or microelectromechanical system that can be turned on by a remote electromagnetic signal, or by a heat or electrically activated release mechanism whereby the portion of the guiding structure just proximal to the lens device system or stent is designed to melt, break, or become extremely weak to axial motion following activation. Thus, the lens device, system, lumen, cylindrical lens, expandable cylindrical lens, expandable tubular lens, or stent could be left in place in the cataract after deployment or placement (and subsequent removal of the surgical tool or guiding structure from the eye) with minimal additional tissue trauma thereby reducing risks of lens subluxation, dislocation, or damage. The diameter of the initial piercing of the lens creating the pinhole, lumen, or tunnel, at first is typically between one and two millimeters, but may be between 0.10 mm. and 5 mm. In some embodiments, the cornea may also be entered from the peripheral cornea using a guiding surgical tool depicted in FIG. 1 that may have memory to bend, redirect the guide, catheter, wire, insertion system and lens system device posteriorly through the lens so that the eye need not be entered through the central cornea. In such a case, there would be a small corneal incision made with a separate blade or needle, and then the lens device system/guiding structure with curvature memory could be advanced into the eye, or the straight guiding structure/lens device deployment system apparatus with memory for curvature may penetrate the outer cornea directly with a sharp tip. There may be a secondary aspect to such a straight placement system such that an outer shell, sleeve or double barrel system allows for the memory or curvature to become manifest following the retraction or removal of the outer shell, sleeve or outer hollow barrel. The stent or lens system device 301 is placed in or near the visual axis of the eye. In some embodiments of the present invention, the stent or lens system device 301 is placed outside the visual axis of the eye, but is still able to improve sight. In some embodiments of the present invention, the lens system device, stent, small diameter cannula or other pinhole device may be mechanically forced through the cataractous lens using a mechanical system such as a spring loaded mechanism or screw/threaded rotational mechanism or the like. A mechanism to force insertion of the lens system device, stent or other pinhole device may also be electrically or battery powered, and may, in some embodiments, include a hand powered, mechanical or electrical system to drive the lens system device, cylindrical lens, expandable cylindrical lens, tubular lens, stent or other pinhole device carefully through the lens. The mechanical energy system aspect of the device may utilize heat energy, ultrasound, laser, cautery, ionization, or other electromechanical energies to ease placement through the cataractous lens. Such mechanisms may also be used, in some embodiments of the present invention, to help drive the guide wire through the lens. In this described procedure, the pupil may be dilated or may be undilated. The procedure may be used with viscoelastic materials or without, and may include, in some embodiments of the present invention, a self healing incision. An irrigation system may be a part of the device or the deployment system of the present invention in some embodiments of the present invention. Some embodiments of the present invention may include an intraocular lens within the stent assembly 901. The intraocular lens is placed through the cataract, without removing the cataract. The intraocular lens will have a small diameter optic, for example, less than 4 mm. The lens may be flexible, expandable, or rigid, and may be preloaded in the surgical end of the operative tool or the operative end of the tool and then subsequently advanced through the bend in the tool during use. The same concept applies to any stent or lens system device that may be deployed by the apparatus—it may be preloaded in the surgical or operative end of the tool, or it may be secondarily advanced over a guide wire or secondarily placed with a separate guiding structure. Furthermore, after creating the opening through the cataract, a piggy back intraocular lens, or larger optic may be placed in the anterior chamber or in the anterior segment in front of the cataract but behind the iris to help focus light on the retina. The human lens, for reference, is 9 mm. in diameter and 4 mm. thick. Standard optics used in cataract surgery have an optic diameter between 6 mm and 4 mm. In some embodiments of the present invention, the stent may be conical with the anterior opening larger than the posterior opening. A wide angle lens to allow for a larger field of view on the retina may be utilized in this system. The stent or intraocular lens may, in some embodiments of the present invention, have a flexible flange on the lead end and trailing end of the stem, cylindrical lens, expandable cylindrical lens, tubular lens, or lens device system to help secure it in position, enhance integration with the in situ lens capsule, and prevent egress of cataractous material. The intraocular lens may further, in some embodiments of the present invention, be telescoping. The lens system device may come in various powers to optimally correct for refractive error.
In FIG. 10, the lens system device 301 is properly positioned in and through the cataract, and the guiding structure 201 is retracted through the surgical tool 100. These methods may be performed by a physician or a non-physician under topical, local, or general anesthesia. The methods may be performed with or without the use of viscoelastic material or balanced saline irrigation. The lens system device 301 (including such devices as stents, cables, cannulas, catheters, a clear tunnel, intraocular lens systems, cylindrical lens, expandable cylindrical lens, tubular lenses, expandable lenses, or polymer lenses) extends through the entire lens of the eye. The length of this stent, cable, new lumen, lens system, or material can extend 3 mm in front of the anterior surface of the lens and up to 18 mm posterior to the posterior capsule of the lens. Typically the length will extend 0.5 to 2 mm anteriorly and 0.5 to 3 mm posteriorly through the lens.
FIG. 11 depicts the lens system device 301 after expansion, or the way a nonexpendable cannula will appear. Techniques to expand a stent are well known to those skilled in the art, and include self expanding stents, expansion by a balloon mechanism, and the like. The lens system device 301 after expansion creates a lens, passageway for light, or patent lumen in the lens of a mammal. In one embodiment, the stent or cannula system is non expandable. In another, it is expanded to 2 mm in diameter, up to 4 mm in diameter. The lens system device or cylindrical lens or expandable cylindrical lens may also be made from a hydrophilic material that expands upon placement in an aqueous environment such as an eye. Suitable hydrophilic materials may include, but are not limited to, Hema(Poly-hydroxy-ethylene thacrylate), 2-hydroxyethyl methacrylate (HEMA), hydrophilic acrylic, 2 HEMA hydrophilic acrylic, hydrogels, hydrophilic polymers, fluorocarbon-sulfone.
FIG. 12 shows the lens system device 301 fully installed, with the related surgical tools removed. In FIG. 12, the lens system device 301 has a taper 303. Other embodiments of the present invention may have a modified taper, or no taper, such as depicted in FIG. 13. The taper, and/or the external surface of the stent, cylindrical lens, expandable cylindrical lens, tubular lens, or lens system device, may have threads to assist its deployment into the cataractous lens, and the tapered aspects may convey other mechanical advantages.
Light ray tracing analysis shows that a reasonable image can be formed on the retina using an intraocular pinhole system, and one embodiment of this invention is an intra-cataract pinhole intraocular lens system. Light ray tracing analysis shows that a reasonable image can be formed on the retina using a cylindrical lens or an expandable cylindrical lens.
Referring now to FIGS. 14-18, a surgical tool is depicted for deployment of a surgical implant comprising a cylindrical lens. The surgical tool is further described in U.S. patent application Ser. No. 14/265,231 filed Apr. 29, 2014 entitled “Apparatus And Method For The Treatment of Presbyopia in a Pseudophakic Eye” by Dr. David M. Kleinman, the entire disclosure of which is incorporated herein by reference in its entirety.
A tubular lens, having been previously described, may be considered hollow of material such as in a traditional tube. However, for purposes of this invention and the description herein, hollow may also refer to the optical properties of the lens where the tubular lens is optically hollow in that light (photons), as opposed to material (such as liquids and gases), can pass through the interior of the tubular lens. In addition to such a tubular lens of the present invention where the interior of the lens is optically hollow, the lens of the present invention may also be referred to herein as a cylindrical lens. A cylindrical lens, thus, is capable of transmitting light. It may have optical power in some embodiments. It may be made of a polymer. Furthermore, the lens may be expandable. Such a lens system device comprises a generally cylindrical shape having a cylindrical axis, an expandable material capable of increasing its volume upon implantation in a cataractous lens of an eye of a patient, a lens contained within the cylindrical shape to allow for the passage of light, wherein the cylindrical lens is capable of traversing a surgical tool along the cylindrical axis of the cylindrical lens while maintaining its generally cylindrical shape after exit of the surgical tool, and wherein the cylindrical lens is capable of being implanted in the cataractous lens of an eye of a patient with the cylindrical axis of the cylindrical lens generally perpendicular to a surface of the cataractous lens. In some embodiments of the present invention, the implanted lens may be cylindrical or generally cylindrical in shape
In FIG. 14, a perspective view of a surgical tool of the present invention 1400 is depicted. The surgical tool 1400 may be made from a surgically compatible material such as, for example, stainless steel or medical grade plastic. The surgical tool 1400 may be machined, cast, or the like. The surgical tool 1400 is formed with an angle (or bend) to allow entry of the surgical tool 1400 through the peripheral cornea of the eye where the angle is formed by the convergence of a shaft 1409 for surgical handling and an operative head 1401 for surgical placement of a cylindrical lens. The surgical tool has a first edge 1403 and a second edge 1411. These edges meet to form a pointed blade. A delivery conduit 1705 as seen in FIG. 17 has a delivery conduit exit 1405 for deployment of a cylindrical lens. The shaft 1409 may be rounded, oval, square, octagonal, or other such geometries. The operative head 1401 may be joined with the shaft 1409 at an angle such as ninety (90) degrees, or within sixty (60) degrees greater or less than ninety degrees, and may, in some embodiments of the present invention, have a radius at the angle. Thus, the instrument has a bend, and the angle is calculated from the angle of intersection between parallel projections generated from the direction of the proximal and distal ends of the shaft. In some embodiments of the present invention, an irrigation conduit may travel the length of the shaft 1409 and exit at the irrigation conduit exit 1503 as seen in FIG. 15. An irrigation conduit fitting 1407 is in fluid communication with the irrigation conduit (not shown in FIG. 14, see FIG. 17, item 1707). The irrigation channel maintains the anterior chamber during the surgical procedure. The irrigation conduit may or may not have a bend. The drawings show two conduits. The device may have one or three conduits. The conduits may have specific unchangeable roles, or may be interchangeable. In one embodiment there is one infusion conduit and one conduit for an energy source on a guiding structure, and another conduit for a lens on a guiding structure. One or two of these conduits may be combined or even excluded. The operative head 1401 has a sharp tool for penetration of a peripheral cornea of the eye, as shown for example in FIGS. 18A and 18B. The surgical tool 1400 may, in some embodiments of the present invention, have a sharp tool for cutting. The sharp tool may have a different or smaller appearance in some embodiments of the present invention. The sharp tool may be placed near, or a part of, the first edge 1403 or the second edge 1411.
FIG. 15 is a rotated perspective view of the surgical tool of FIG. 14 where the irrigation conduit exit 1503 can be seen at the first edge 1403.
FIG. 16 is a further rotated plan view of the surgical tool of FIG. 14 where the delivery conduit exit 1405 can be seen. FIG. 17 is a cross sectional view of the surgical tool of FIG. 14 cut along line B-B of FIG. 16. The delivery conduit 1705 can be seen as it travels along the shaft 1409 to its point of exit 1405. In this figure, the cylindrical lens is within the conduit of the surgical tool. In one embodiment it is traversing the surgical tool in a non-expanded, dehydrated or partially dehydrated state such that once placed through the cataractous lens it is able to expand to meet pre-specified optical characteristics. The irrigation conduit 1707 can also be seen as it travels along the shaft 1409. The irrigation conduit fitting 1407 may be connected to an external source of fluid by way of a hose, tube, plastic tubing, Luer lock style connectors, conduit, or the like.
FIG. 18A shows the cylindrical lens 1701 fully installed. A surgical instrument such as a needle or other such sharp instrument may be used to pierce an opening in the natural lens of the eye for placement of the cylindrical lens 1701. Alternatively, laser light or laser energy, or other sources of energy may be used to pierce the anterior capsule of the lens and create space or allow for the creation of space for insertion of the cylindrical lens. The cylindrical lens 1701 is pushed through the delivery conduit 1705 of the surgical tool as shown in FIG. 17 for insertion into a surgical opening in the natural lens of the eye. Once the cylindrical lens 1701 is placed in the natural lens of the eye, it will either remain in its current size or expand. In one embodiment it will naturally begin to uptake liquid and increase in diameter to a predetermined size. In some embodiments this expansion will allow for more complete filling of the surgical opening in the natural lens and will ensure a tight fit that prevents the cylindrical lens 1701 from becoming dislodged. In other embodiments, simply placing the cylindrical lens in the cataract will create the fixation required for proper function. FIG. 18B depicts the cylindrical lens 1701 fully installed and expanded. The expansion diameter may be any value between 101% and 1000% of the original cylindrical lens diameter. The lens may be molded, designed, partially expanded or partially hydrated such that the diametrical expansion far exceeds any expansion in length once the cylindrical lens is placed in the cataract. Thus, the internal diameter of the lens may expand maximally while the length expands minimally when comparing its size at preparation for entry into the surgical tool or inside the surgical tool with its ultimate size within the cataract of an eye. In some embodiments of the present invention, the cylindrical lens 1701 may contain an active pharmaceutical agent formulated for release inside the eye.
FIG. 19A depicts the cylindrical lens of the present invention 1901 in an unexpanded state and FIG. 19B depicts the cylindrical lens of the present invention in an expanded state. Although the length may expand to a small degree, the predominating expansile characteristic from the cylindrical lens in the surgical tool to the cylindrical lens in the cataract is diametrical. Of course, the volume of the lens expands.
A cylindrical lens 1901 is described that can expand and is capable (based on optical engineering designs) of providing image quality better than 20/400 and a field of view larger than 5 degrees when placed through a cataract. In some embodiments of the present invention the field of view may be between 5 degrees and 180 degrees. The main embodiment of the present invention has a field of view of 20 to 50 degrees. The cylindrical lens 1901 may provide an acuity of 20/20, or somewhere between 20/20 and 20/100.
The apparatus and method for treating a cataractous eye may comprise a surgical tool formed with an angle to allow entry of the surgical tool through the peripheral cornea of the eye where the angle is formed by the convergence of a shaft for surgical handling and an operative head; the surgical tool is used to maintain the anterior chamber, to create cylindrical space in the cataract and for the placement of a cylindrical lens through the cataract.
Light ray tracing analysis shows that a reasonable image can be formed on the retina using the cylindrical lens 1901. An optical engineer using ray tracing technology can demonstrate that visual acuity potential is better than 20/100 and in some embodiments can be as good as 20/20 in cylindrical lens designs.
In some embodiments, the length of the cylindrical lens 1901 of the present invention is longer in the anterior-posterior direction when in situ than it's diameter in the x-y (or surface) plane. In some embodiments the lens may be equal in its surface diameter direction when compared to its length. In other words, the length of the intraocular implant is greater than (or equal to) the diameter of either end. This cylindrical lens is thus much different than a traditional IOL where the lens is disk like and much longer in diameter than its anterior-posterior length.
The cylindrical lens 1901 is also different in that it is placed in position in situ through the cataract. While parts of the lens may be removed to create space or a central anterior posterior core, the cylindrical lens 1901 in some embodiments does not sit independently in the capsular bag without residual cataract present. This characteristic is a fundamental difference from standard surgically placed intraocular lenses where the goal is to remove as much of the cataractous lens as possible. Here, only a portion of the cataract is removed to allow for placement of the cylindrical intraocular lens.
The novel cylindrical lens 1901 in some embodiments has a wide depth of field where both near and distant objects are in focus. Thus multi-focality in a cylindrical lens of the present invention is a novel intraocular implant. Near may be defined as within 3 feet or less of the anterior corneal surface, and far may be defined as 10 or more feet from the surface of the anterior corneal surface. These distances are general, and more or less near is within arms range and far is beyond arms range. Multi-focality means a patient can see well enough to function at near and far without spectacle or contact lens correction to perform visual tasks at near and far. By some definitions the novel cylindrical lens is multifocal because objects at near and far are simultaneously in focus. The lens can also be called a lens with a wide depth of field where depth of field is the amount of distance between the nearest and farthest objects that appear in acceptably sharp focus.
In some embodiments, the cylindrical lens has an index of refraction that is greater than one. Of course, in certain situations, the cylindrical lens may also have an index of refraction that is less than or equal to one.
The cylindrical lens 1901 can be formed from hydrophilic polymers so that it expands in situ. The cylindrical lens 1901 is expandable. The cylindrical lens is not rigid in some states and can be advanced through a surgical tool with a bend of 10 degrees or more. Such a surgical tool is described in U.S. patent application Ser. No. 14/265,231 filed Apr. 29, 2014 entitled “Apparatus And Method For The Treatment of Presbyopia in a Pseudophakic Eye” by Dr. David M. Kleinman.
The cylindrical lens has a length of between 3 mm. and 20 mm. and a diameter between 0.5 mm. and 6 mm. In some embodiments the length at the time of entry into the surgical tool is between 5 mm. and 8 mm. and the diameter at the time it is placed into the surgical tool is between 0.5 mm. and 2 mm.
In one embodiment of the present invention the cylindrical lens 1901 has an expanded length of between 6 mm. and 10 mm. long and has an expanded diameter of between 2 to 4 mm.
The cylindrical lens 1901 may have internal or external baffles to prevent the spreading of light in a particular off axis direction.
The cylindrical lens 1901 may comprise a lens with expandable material, or the expandable material may also serve as the lens.
FIG. 20 depicts the cylindrical lens 2001 with an external absorptive coating such as a black dye. The black dye prevents off axis light from entering the cylindrical lens from the side and also helps the cylindrical lens with regard to optical performance within the eye.
The cylindrical lens is optically clear, and may or may not bend the light through its internal structure depending on the specific optical and patient objectives to be met. The cylindrical lens may impart refractive correction to the eye. The cylindrical lens is designed to allow visible light to shine on the retina so as to impart vision or improved vision. In some embodiments the lens focuses light on the retina, in others it allows light rays that are perpendicular to the cornea to travel to the retina. Ideally a lens will transmit 100% of incoming light. In practice, however, there is some attenuation, loss of transmittance, or loss of the amount of light as it enters and travels through a lens. Causes of loss of transmittance include reflections, scatter, and absorption. The cylindrical lens of the current invention in practice, in some embodiments, attenuates or causes decreases in the amount of light that can reach the retina compared to a perfect theoretical lens which may transmit 100% of the light that falls on the anterior lens surface. In practice, the amount of attenuation of light will not prevent the cylindrical lens from improving vision. In some embodiments the cylindrical lens transmits between 99% and 1% of the light that enters the cornea to the retina. In some embodiments the lens transmits greater than 10%, 20%, 25%, 30%, and 40% of the light that enters the cornea. The cylindrical lens allows for improved illumination of the retina in cataractous eyes. Improved illumination can mean reduced scatter, more light, or in focus light. The relative illumination of the retina in some embodiments is less than the illumination that would be imparted by a perfect lens which would have nearly 100% relative illumination. In some embodiments the cylindrical lens is designed to provide improved retinal image quality despite veiling glare which may be contributed by portions of the residual cataract. The modulation transfer function (MTF) of the cylindrical lens may have some decrease due to veiling glare. MTF is an important aid to objective evaluation of the image-forming capability of optical systems. Not only does the MTF provide a means of expressing the imaging quality of optical systems objectively and quantitatively, but it can be calculated from the lens design data The optical transfer function (OTF) is a complex transfer function where the modulus of the function describes the modulation transfer, and the argument of the function describes the phase transfer in an optical system. OTF is used by optical engineers and scientists to describe how the optics project light from the object or scene onto a photographic film, detector array, retina, screen or simply the next item in the transmission chain. The cylindrical lens may show a decrease of OTF or MTF compared to a perfect lens in a model eye. However, a key aspect to this cylindrical lens in some embodiments is that despite some decrease of MTF, OTF, or transmittance of light, the cylindrical lens allows for improved illumination of or focus of light on the retina compared to the quality of vision with the cataract. Veiling glare is stray light in lenses and optical systems caused by reflections between lens elements and the inside barrel of the lens. For the purposes of this invention, veiling glare can include scatter induced by the surrounding in situ cataract. Decreases in MTF or OTF can thus be external to the cylindrical lens such as veiling glare from the cataract, or internal to the cylindrical lens when actual function is compared to an ideal lens. Thus, the lens has a transparency acceptable for improving vision in a cataractous eye. The transparency of the cylindrical lens allows for acceptable illumination of the retina to improve visual acuity or potential visual acuity. The lens may be molded or machined or manufactured through other polymer manufacturing techniques. The cylindrical lens when placed in situ in a cataract allows for an image to be formed on the retinal surface. The cylindrical lens improves vision in a cataractous eye once placed. The cylindrical lens allows for a clear path for light through a cataractous lens. The cylindrical lens is placed through an insertion device. The cylindrical lens is manufactured from biocompatible polymeric materials.
The cylindrical lens may have a convex or concave surface on either the anterior or posterior lens surfaces. The lens may have a spherical or aspheric surface. The cylindrical lens is expandable.
As previously described, the cylindrical or tubular lens comprises a taper at an end of the intraocular implant to facilitate insertion thereof.
Lastly, FIG. 21 depicts an alternate embodiment of the cylindrical lens 2101 having a taper such that the first end 2103 has a smaller diameter than the second end 2105 in the form of a truncated cone. This truncated conical shape and related implantable lens has properties akin to the cylindrical lens previously described. For example, in some embodiments, the implantable lens has an index of refraction that is greater than one. Of course, in certain situations, the implantable lens may also have an index of refraction that is less than or equal to one.
It is, therefore, apparent that there has been provided, in accordance with the various objects of the present invention, an apparatus and method for the treatment of cataract. While the various objects of this invention have been described in conjunction with preferred embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the present invention and the various embodiments described and envisioned by this specification, claims, and attached drawings.

## Claims

1. A cylindrical lens for in situ placement in a cataractous lens of an eye of a patient, the cylindrical lens comprising:
a generally cylindrical shape comprising a cylindrical axis, an anterior lens surface and a posterior lens surface;
an expandable material capable of increasing its volume upon implantation in a cataractous lens of an eye of a patient; wherein the cylindrical lens is optically clear to provide a transparncy acceptable for improving vision in the eye of the patient and allows for the passage of light along the cylindrical axis of the cylindrical lens;
wherein the cylindrical lens has refractive power to focus the light on a retina of the eye of the patient;
wherein the cylindrical lens is capable of traversing a bent surgical tool in a non-expanded state along the cylindrical axis of the cylindrical lens while maintaining its generally cylindrical shape after exit of the surgical tool; and
wherein the cylindrical lens is capable of being implanted in the cataractous lens of the eye of the patient with the cylindrical axis of the cylindrical lens generally perpendicular to a surface of the cataractous lens.

2. The cylindrical lens of claim 1, further comprising a taper at an end of the cylindrical lens.

3. The cylindrical lens of claim 1, wherein the expandable material is a hydrophilic material.

4. The cylindrical lens of claim 3, wherein the hydrophilic material is a hydrophilic polymer.

5. The cylindrical lens of claim 1, wherein the cylindrical lens has an index of refraction that is greater than one.

6. The cylindrical lens of claim 1, further comprising an absorptive coating on an exterior of the cylindrical shape.

7. The cylindrical lens of claim 1, further comprising an active pharmaceutical agent.

8. The cylindrical lens of claim 1, wherein a length of the cylindrical lens is greater than the diameter of either end.

9. The cylindrical lens of claim 1, wherein the cylindrical lens is multi-focal.

10. The cylindrical lens of claim 1, wherein the cylindrical shape has a length of between 4 mm. and 20 mm. and a diameter of between 0.5 mm. and 6 mm.

11. An implantable lens for in situ placement in a cataractous lens of an eye of a patient, the implantable lens comprising:
a truncated conical shape comprising a conical axis, an anterior lens surface and a posterior lens surface;
an expandable material capable of increasing its volume upon implantation in a cataractous lens of an eye of a patient;
wherein the implantable lens is optically clear to provide a transparency acceptable for improving vision in the eye of the patient and allows for the passage of light along the conical axis of the implantable lens;
wherein the implantable lens has refractive power to focus the light on a retina of the eye of the patient;
wherein the implantable lens is capable of traversing a bent surgical tool in a non-expanded state along the conical axis of the implantable lens while maintaining its generally truncated conical shape after exit of the surgical tool; and
wherein the implantable lens is capable of being implanted in the cataractous lens of the eye of the patient with the conical axis of the implantable lens generally perpendicular to a surface of the cataractous lens.

12. The implantable lens of claim 11, wherein the expandable material is a hydrophilic material.

13. The implantable lens of claim 11, wherein the hydrophilic material is a hydrophilic polymer.

14. The implantable lens of claim 11, wherein the implantable lens has an index of refraction that is greater than one.

15. The implantable lens of claim 11, further comprising an absorptive coating on an exterior of the truncated conical shape.

16. The implantable lens of claim 11, further comprising an active pharmaceutical agent.

17. The implantable lens of claim 11, wherein the implantable lens is multi-focal.

18. The implantable lens of claim 11, wherein the truncated conical shape has a length of between 4 mm. and 20 mm. and a base diameter of between 0.5 mm. and 6 mm.