Patent Application
20150305927
This invention relates to tools for use in ophthalmic surgeries such as, for example, surgeries for patients with aniridia, iris trauma and other disorders or injury and potentially cosmetic change of iris or eye color.
Conventional corneal tattooing for medical purposes involves the use of a 30-gauge needle to apply titanium or iron dioxide pigment to the cornea using small punctures to the eye. It typically takes 20 to 30 minutes to make between 200 to 1,000 small needle punctures to place the dye. The procedure is frequently incomplete, with a high re-treatment rate, and it can be painful. The dye coverage applied by the direct injections may also be incomplete.
Embodiments of the invention provide methods and related surgical tools suitable for ophthalmic corneal tattoo surgery.
Embodiments of the invention are directed to methods of performing corneal tattoo surgery. The methods can include: selecting an incision location, size and depth for a corneal flap, channel or pocket; then transmitting laser pulses to a lens of an eye of a patient to generate the corneal flap, channel or pocket; and applying a corneal tattoo substance to an internal corneal tissue and/or layer.
The corneal tattoo can be applied to the corneal layer to be in-line with a region of an iris over a pupil.
The applying can include manually pushing the corneal tattoo substance downward onto the cornea layer using a surgical tool to form a continuous layer or layers over a target area to form the corneal tattoo.
The selecting can be carried out by a user selecting a ring inner and outer diameter for a channel via a user interface in communication with a Femtosecond laser optical system. The transmitting laser pulses can be carried out by the Femtosecond laser optical system.
The applying the corneal tattoo substance is carried out using at least one opaque, viscous dye having a clinically effective life of at least five years.
The method can also include applying a striation pattern using a secondary dye onto the applied corneal tattoo to thereby generate a more natural looking iris for the corneal tattoo.
The method can include, before the applying step, selecting a color corresponding to a primary color of the iris of the patient.
The corneal tattoo can be applied at a corneal depth of between 150 μm to 300 μm.
The selecting and transmitting steps can be carried out to generate an annular corneal channel. The annular corneal channel can have an inner diameter of between 4-5 mm and an outer diameter that is between 1 mm to 3 mm larger than the inner diameter.
The patient can be treated for aniridia or iris trauma.
Other embodiments are directed to surgical tools for corneal tattooing. The tools can include a handle with a shaft that is attached to a corneal applicator, the corneal applicator sized and configured to push against an internal (e.g., dissected) corneal layer of a cornea to distribute a viscous, opaque corneal tattoo substance.
The surgical tool can be in combination with at least one container of an opaque, viscous medical grade corneal tattoo substance.
The corneal applicator can include at least one depression or well for holding a quantity of the corneal tattoo substance.
The corneal applicator can have a thickness between 1 micron and 5 mm and extends off only a single side of the shaft.
The surgical tool can include a plurality of vertically extending through holes in a depression or well.
The corneal applicator can have a radially extending length and a circumferentially extending width associated with an outer perimeter edge. The outer perimeter edge can extend away from the shaft at an angle between 10-180 degrees.
The corneal applicator can be arcuate with opposing circumferentially spaced apart first and second ends. The first end can be attached to the shaft and the second end can be a free end. The free end can reside circumferentially spaced apart from the shaft at between 90-180 degrees.
Yet other embodiments are directed to surgical kits or sets of components for treating an eye. The sets/kits can include: a surgical tool with a corneal applicator; and at least one container of a medical grade corneal tattoo substance. The corneal tattoo substance can be formulated to be opaque and viscous.
The kit or set can include a striation tool configured to allow a user to apply a striation pattern over an opaque primary corneal tattoo that covers a continuous surface area over a target treatment site of a corneal layer to thereby form a more natural iris pattern for a corneal tattoo.
The kit and/or set of tools can include a plurality of containers of the medical grade corneal tattoo substance, each of a different color.
The corneal applicator can either (a) have a radially extending length and a circumferentially extending width associated with an outer perimeter edge, wherein the outer perimeter edge extends away from the shaft at an angle between 10-180 degrees or (b) be arcuate with opposing circumferentially spaced apart first and second ends. The first end can be attached to the shaft and the second end can be a free end that resides circumferentially spaced apart from the shaft at between 90-180 degrees.
Still other embodiments are directed to a femtosecond laser surgical system for eye treatments. The system includes: a femtosecond laser; a controller in communication with the laser, the controller comprising or in communication with a corneal tattoo module, wherein the corneal tattoo module allows a user to select laser inputs including a corneal channel depth between 100 and 300 μm; and a display having a user interface in communication with the controller. The user interface can allow a user to overlay a virtual ring over an image of an eye of a patient to identify a desired a ring size that will allow access to an internal corneal layer (which may be in-line with a region of an iris over a pupil).
The system can include an imaging system in communication with the controller. The system can include a color match module for evaluating an eye color of a patient based on an image taken using the imaging system and providing color information to a user for selecting an appropriate product or color for a corneal tattoo substance.
Some embodiments of the invention provide methods, laser systems and tools that are configured to create a corneal tattoo to form a pinhole effect in the central cornea by creating a very small aperture area surrounded by an opaque area of tattoo substance (pigment/dye) with an outer diameter of 1-4 mm.
The foregoing and other objects and aspects of the present invention are explained in detail in the specification set forth below.
It is noted that aspects of the invention described with respect to one embodiment, may be incorporated in a different embodiment although not specifically described relative thereto. That is, all embodiments and/or features of any embodiment can be combined in any way and/or combination. Applicant reserves the right to change any originally filed claim or file any new claim accordingly, including the right to be able to amend any originally filed claim to depend from and/or incorporate any feature of any other claim although not originally claimed in that manner. These and other objects and/or aspects of the present invention are explained in detail in the specification set forth below.
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawings will be provided by the Office upon request and payment of the necessary fee.
The present invention will now be described more fully hereinafter with reference to the accompanying figures, in which embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Like numbers refer to like elements throughout. The term “Fig.” (whether in all capital letters or not) is used interchangeably with the word “Figure” as an abbreviation thereof in the specification and drawings. In the figures, certain layers, components or features may be exaggerated for clarity, and broken lines illustrate optional features or operations unless specified otherwise. In addition, the sequence of operations (or steps) is not limited to the order presented in the figures and/or claims unless specifically indicated otherwise. In the drawings, the thickness of lines, layers, features, components and/or regions may be exaggerated for clarity and broken lines illustrate optional features or operations, unless specified otherwise.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms, “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises,” “comprising,” “includes,” and/or “including” when used in this specification, specify the presence of stated features, regions, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, regions, steps, operations, elements, components, and/or groups thereof.
It will be understood that when a feature, such as a layer, region or substrate, is referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when an element is referred to as being “directly on” another feature or element, there are no intervening elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other element or intervening elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another element, there are no intervening elements present. Although described or shown with respect to one embodiment, the features so described or shown can apply to other embodiments.
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the present application and relevant art and should not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
The word “about” means that the size or amount referred to can vary from the particular amount, typically by +/−10%.
The term “sterile” means that the device meets medical cleanliness standards for surgical use.
As used herein, the term “corneal tattoo” refers to a coating of an opaque or substantially opaque substance (e.g., a pigment) applied to the cornea at a sub-exterior surface depth at a location that is typically in line with a portion of a properly functioning or formed iris above the pupil to resolve, repair or improve vision problems and/or glare. The term “substantially” with respect to “opaque” means that light transmission associated with normal ambient room lighting or natural light is reduced by at least 90% relative to a surface without such a substance.
The substance used to form the corneal tattoo T can comprise a medical grade substance, preferably one that has a long life so as to avoid undue numbers of repeat procedures. The substance can have a clinically effective life, once applied, that is at least 5 years, typically between about 5 years to about 100 years or more. The substance can comprise an ink and/or insoluble pigment such as one or more of an Indian ink, iron oxide and/or titanium dioxide. The substance may alternatively or additionally comprise a chemical dye that may comprise metal salts such as gold chloride, silver nitrate, platinum chloride or the like. The substance can be viscous and/or paste-like so as to adhere or remain in a desired spot or treatment area on the cornea surface S. The term “viscous” when referring to the corneal tattoo substance means that the substance has a sufficiently thick consistency so that it does not flow at body temperature but can be spread over and/or within corneal tissue to cover a target treatment site. The substance can be gelatinous or pasty, for example.
In preferred embodiments, a titanium dioxide pigment of a desired color (or black or white) or a titanium dioxide pigment mixture of a plurality of colors can be applied to correspond with a color associated with a respective patient's iris. The substance can be applied in one or more layers. Where different layers are used, different layers may comprise different colors of the same or different substances.
The corneal tattoo T can be formed in situ directly on the cornea using an appropriate surgical tool and corneal tattoo substance, e.g., pasty pigment. The surgical laser systems may be configured to project a shaped light guide that form a virtual annular template at a desired corneal tattoo site. It is alternatively contemplated that the corneal T can be pre-formed as a semi-solid substance with a binder, substrate, film, or other carrier that can remain, dissolve or be removed after or during the implantation, so that the annular tattoo retains or takes the annular shape while it is implanted.
It is contemplated that a corneal tattoo T may be an alternative to the corneal inlay, intended to improve near vision without compromising distance vision in emmetropic presbyopes and possibly non-emmetropes as well such as the Kamra™ inlay from AcuFocus in Irvine, Calif., which uses the pinhole principle to increase depth of field. See, Waring GO 4th. Correction of presbyopia with a small aperture corneal inlay. J Refract Surg 2011; 27:842-5; Seyeddain O, Hohensinn M, et al. Small-aperture corneal inlay for the correction of presbyopia: 3-year follow-up. J Cataract Refract Surg 2012; 38:35-45; Chayet A, Garza E B. Combined hydrogel inlay and laser in situ keratomileusis to compensate for presbyopia in hyperopic patients: One-year safety and efficacy. J Cataract Refract Surg 2013; 39:1713-21; Garza E B, Gomez S, Chayet A, Dishier J. One-year safety and efficacy results of a hydrogel inlay to improve near vision in patients with emmetropic presbyopia. J Refract Surg 2013; 29:166-72; and Limnopoulou A N, Bouzoukis D I, et al. Visual outcomes and safety of a refractive corneal inlay for presbyopia using femtosecond laser. J Refract Surg 2013; 29:12-8. The contents of these documents are hereby incorporated by reference as if recited in full herein.
In preferred embodiments, access to the target corneal surface S is created using a Femtosecond laser, e.g., “Femto-Assisted Corneal Tattooing.” As is well known to those of skill in the art, Femtosecond lasers have been proposed for use in cataract surgeries. See, e.g., Nagy et al, Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. J Refract Surg 2009; 25:1053-60. See also, Ella Faktorovich, Femtodynamics: A Guide to Laser Settings and Procedure Techniques to Optimize Outcomes with Femtosecond Lasers, (Slack Inco., 1st edition, 2009). The contents of these documents are hereby incorporated by reference as if recited in full herein.
The inventor has found that Femtosecond laser-assisted corneal tattooing has shown good early results for patients with aniridia, iris trauma and other disorders.
The Femtosecond laser allows the surgeon to make a custom, laser generated corneal pocket or channel (or flap) at any location.
In some embodiments, corneal channels having a depth of about 150 μm to about 300 μm can be generated and the corneal tattoo T can be applied at this depth.
As shown in
The Femtosecond laser system 10 can include a corneal tattoo module 75 that can be configured to provide a selection of shapes and sizes that are optimized for use to create appropriate corneal tattoos at appropriate controlled depths, typically limited to between about 100 μm to about 300 μm, more typically between about 150 μm to about 250 μm, Examples of currently available femtosecond laser optical systems are believed to include Alcon LenSx or Alcon FS200 (Alcon Laboratories, Ft Worth, Tex., USA), OptiMedica Catalys (Optimedica Corp, California, USA), LensAR (LensAR Inc, Florida, USA), the FS IntraLase™ FS Laser system from Abbott Medical Optics, Technolas (Technolas Perfect Vision GmbH, Germany) as well as femtosecond laser systems from Ziemer or Bausch and Lomb. The laser systems 10 typically include an anterior segment imaging system, patient interface and Femtosecond laser to image, calculate and deliver the laser pulses.
Traditional LASIK flaps were generally ranged in thickness from 140 to 180 microns. This is about one third of the total corneal thickness, given that the average normal cornea is about 540 microns in thickness. Newer types of microkeratomes and IntraLase™ lasers can create thinner flaps and channels. Many LASIK surgeons prefer a flap thickness between 100 and 130 microns. The flap F for corneal tattooing may be made at a greater depth than for cataract surgeries as noted by the examples of depths described above. The annular corneal channels A can have an inner diameter between about 4-5 mm and the outer diameter can be 1 mm to about 4 mm larger. The outer diameter is typically between about 6 to 10 mm, such as 6 mm, 6.5 mm, 7 mm, 7.5 mm, 8 mm, 8.5 mm, 9 mm, 9.5 min or 10 mm.
Once the corneal pocket/channel A or flap F is created at a suitable location for a corneal tattoo T, which can be patient specific as to size, shape and depth, the tattoo substance can be applied. Unlike conventional multiple injection needle application, a wider area can be directly covered using one or more applicators for a coating that has a continuous surface area.
The bottom 117 can comprise one or more apertures 118, typically a plurality of small apertures on a leading free end thereof, to allow fluid to travel therethrough. The apertures 118 can be held in at least one well 119 (e.g., depression or recess in a substrate or other material on or in the blade or distal end 115). The small apertures can be in the sub-millimeter, e.g., micron and/or nanometer size range.
The bottom 117 can have a thin thickness that can be in the nanometer, micron or millimeter range, typically between about 1 micron to about 10 mm, more typically between about 1 micron and 5 mm, such as about 10 microns, about 20 microns, about 30 microns, about 40 microns, about 50 microns, about 60 microns, about 70 microns, about 80 microns, about 90 microns, about 0.1 mm, about 0.5 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm or any number between the noted range. Other suitable thicknesses may be used.
The distal end 115 can have an arcuate or semi-circular configuration as shown and can extend from about 30 to about 90 degrees, shown as about 90 degrees. The outer (free) end of the bottom 117e can be curved and/or tapered. However, the distal end 115 and/or bottom surface 117 can have other configurations.
The width of the bottom 117 can be between about 0.5 mm and about 15 mm, typically between about 0.5 mm and 5 mm, such as about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, and about 5 mm.
The bottom 117 can have a neck portion 117n that can have straight parallel sides. The neck portion 117n can be attached to the shaft 112. The neck portion 117n can extend a distance D1 before merging into radially extending sides of the arcuate body segment 115b. In some embodiments, the distance D1 can be about 2 mm or less, such as between about 10 microns and about 2 mm, typically between about 100 microns and 1 mm.
The arcuate body 115b can have an angular extension α of between about 10-180 degrees, typically between about 10-90 degrees, such as about 10 degrees, about 15 degrees, about 20 degrees, about 25 degrees, about 30 degrees, about 35 degrees, about 40 degrees, about 45 degrees, about 50 degrees, about 55 degrees, about 60 degrees, about 65 degrees, about 70 degrees, about 75 degrees, about 80 degrees, about 85 degrees and about 90 degrees.
The at least one well 119 can have a distal end portion that is wider than a proximal end portion (the proximal end portion residing closer to the shaft 112). The at least one well 119 can be etched, machined, stamped, molded or otherwise formed in the distal end 115 of the tool 100. The at least one well 119 may also be formed using a cooperating material such as a wax on the upper surface of the distal end/bottom 117 (not shown).
In some embodiments, the distal end 115 can have a plurality of adjacent, radially extending wells 119 as shown. The wells 119 can have the same depth or different depths. The wells 119 can have different sizes and/or shapes or all can have the same shape and size.
The at least one well 119 can have a shallow depth that is typically between 1 nanometer and about 10 millimeters (mm). The well depth can be under 1 mm. The depth can be in the micron and/or nanometer size range, such as between 1 nanometer and 100 microns, or between 10 nanometers and 10 microns, for example.
The tool 100 can be used to directly apply the tattoo substance 200, e.g., by dipping, spraying, pouring, injecting and/or coating a top and/or bottom surface 117 of the tool 100 and/or holding the tattoo substance 200 in a well 119 on the distal end portion 115.
The distal end 115 of the tool 100 can be placed on the target corneal tissue and the handle 100h and/or shaft 112 can be rotated to rotate the distal end of the tool 115 about the pupil.
In some embodiments the tool 100 can be configured with at least one well (e.g., a depression or recess in a substrate or other material in or on the blade or bottom 117) 119 that can hold the tattoo substance (e.g., dye or pigment). The at least one well 119 may optionally include at least one small hole in the bottom or floor of the well to aid in the distribution of the tattoo substance but the well may dispense the substance without requiring such a through aperture or hole.
In other embodiments, the tattoo substance can be injected with a separate tool to overlie a target portion of the surface area of the corneal tissue S, then the tool 100 can be used to spread the substance to provide a continuous coating or coverage. The initial applicator (e.g., injector) can comprise a device with a nozzle such as a syringe or needle without requiring direct contact (e.g., no piercing or puncturing).
As shown schematically in
In some embodiments, as shown in
The tool 100 can be provided as first and second tools, one with a clockwise configuration of the arcuate end 117e and the other with a counter clockwise configuration with the color kit 200k or color containers 200c or as a separate kit, tool or set of tools.
This color information can be provided as a recipe to mix a set of different colors of tattoo substances to generate the patient color or the patient color can be provided pre-mixed in a container that can be purchased by product number. If remotely accessible, the corneal tattoo module 75 and/or the color match module 300 can be provided in one or more servers in a single site or a distributed “cloud” based network or system. A local computer can provide a portal for access to one or both modules 75, 300. In some embodiments, the color match module 300 can be provided as a web-based or online service and/or APP allowing a patient or other user to provide an image of the eye that is color matched for subsequent use in the treatment.
The terms “web-based,” “online” or “cloud-based” mean that the service is available using the World Wide Web (Internet), typically via at least one server to communicate with different users. The communication protocol can include hypertext transfer protocol (HTTP). The tattoo module 75 and/or color match module 300 can be provided using cloud computing which includes the provision of computational resources on demand via a computer network. The resources can be embodied as various infrastructure services (e.g., compute, storage, etc.) as well as applications, databases, file services, email, etc. In the traditional model of computing, both data and software are typically fully contained on the user's computer; in cloud computing, the user's computer may contain little software or data (perhaps an operating system and/or web browser), and may serve as little more than a display terminal for processes occurring on a network of external computers. A cloud computing service (or an aggregation of multiple cloud resources) may be generally referred to as the “Cloud.” Cloud storage may include a model of networked computer data storage where data is stored on multiple virtual servers, rather than being hosted on one or more dedicated servers.
As shown by way of example in
The tool 100 and/or 160 can be single use, disposable. The tool 100, 160 can comprise a respective handle 100h, 160h that releasably engages the respective shaft 112. The tools 100, 160 can comprise molded integral or attached polymeric bodies (e.g., handles and shafts).
The tool 100 can be configured so that the shaft 112 and the distal end 115 can comprise a monolithic unitary molded body. In other embodiments the distal end may comprise a metal or ceramic and may be a separate member that attaches to the tool shaft.
The distal end 115 can be provided as a separate component that can engage the shaft 112 and can be provided in more than one size with more than one shape, width and/or radius of curvature to fit different patient eye requirements.
The shaft 112 and the distal end 115 of the tool 100 can be rigid or semi-rigid. The term “semi-rigid” means the distal end can flex somewhat but can substantially retain its shape. Where used, the distal end 162, 163 of striation tool 160 can be rigid, semi-rigid or flexible.
In some embodiments, the corneal tattoo can be used to form a pinhole effect in a central cornea (e.g., for treating presbyopia) by placing the corneal tattoo substance as a “donut” like or annular shape with an open very small center space on the corneal tissue (block 440). The center space is thus surrounded by an opaque area of the applied corneal tattoo substance (pigment/dye). The outer diameter and/or radially extending width of the annular tattoo can be between 1-4 mm.
The foregoing is illustrative of the present invention and is not to be construed as limiting thereof. Although a few exemplary embodiments of this invention have been described, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the claims. In the claims, means-plus-function clauses, if used, are intended to cover the structures described herein as performing the recited function and not only structural equivalents but also equivalent structures. Therefore, it is to be understood that the foregoing is illustrative of the present invention and is not to be construed as limited to the specific embodiments disclosed, and that modifications to the disclosed embodiments, as well as other embodiments, are intended to be included within the scope of the appended claims. The invention is defined by the following claims, with equivalents of the claims to be included therein.
This application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/984,321, filed Apr. 25, 2014 and U.S. Provisional Application Ser. No. 62/015,064, filed Jun. 20, 2014, the contents of which are hereby incorporated by reference as if recited in full herein.
| Number | Date | Country | |
|---|---|---|---|
| 61984321 | Apr 2014 | US | |
| 62015064 | Jun 2014 | US |
