Device and method for marking the cornea

Abstract

A device and method for marking corneal tissue is disclosed. The device includes an ink reservoir portion and an ink resist portion. The ink reservoir portion is annular in shape and the ink resist portion occupies a central area within the annular shape. The ink reservoir portion and the ink resist portion are sized and structured to interface with the central cornea and to apply ink to the corneal tissue. The method includes applying ink to the cornea in an annular pattern.

Claims

1. A method for evaluating a patient's likelihood of success with an implantable pinhole corneal inlay of an eye, comprising: identifying the patient considering the implantable pinhole corneal inlay; applying surgical ink to a central portion of a cornea not deeper than a corneal epithelium of the patient in an annular pattern surrounding a central uninked portion thereby temporarily simulating an optical effect of the implantable pinhole corneal inlay without implanting the corneal inlay until the surgical ink applied to the central portion of the corneal epithelium is lost due to cell replacement; wherein the annular pattern and the central uninked portion have a center point; and further comprising evaluating the patient's response to the simulated optical effect of the implantable pinhole corneal inlay achieved by the application of the surgical ink.

2. The method as claimed in claim 1, further comprising locating the center point on a visual axis of the eye.

3. The method as claimed in claim 1, further comprising locating the center point proximate an axis coinciding with a center of the pupil of the eye.

4. The method as claimed in claim 1, further comprising applying the surgical ink such that the central uninked portion has a diameter of between 1.0 and 2.2 millimeters.

5. The method as claimed in claim 1, further comprising applying the surgical ink such that the central uninked portion has a diameter of 1.6 millimeters.

6. The method as claimed in claim 1, further comprising applying the surgical ink such that the annular pattern has an outside diameter of between 3.2 and 4.4 millimeters.

7. The method as claimed in claim 1, further comprising applying the surgical ink such that the annular pattern has an outside diameter of 3.6 millimeters.

8. The method as claimed in claim 1, further comprising applying the surgical ink to an anterior surface of the corneal epithelium.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Subject matter hereof may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying figures, in which:

(2) FIG. 1 is a front elevational view of a pinhole type corneal inlay according to the prior art;

(3) FIG. 2 is a side sectional view of a pinhole type corneal inlay implanted in a cornea according to the prior art.

(4) FIG. 3 is a front view of a cornea with an application of surgical ink to simulate the effect of a corneal inlay of the pinhole type;

(5) FIG. 4 is a side sectional view of a cornea with ink applied to the anterior corneal epithelium according to an example embodiment of the invention;

(6) FIG. 5 is a front perspective view of a corneal ink applicator according to an example embodiment of the invention;

(7) FIG. 6 is a side elevational view corneal ink applicator adapted to be used with a Goldmann tonometer according to an example embodiment of the invention;

(8) FIG. 7 is a side elevational view corneal ink applicator adapted to be used with a slit lamp biomicroscope according to an example embodiment of the invention;

(9) FIG. 8 is a perspective view of a well corneal ink applicator according to an example embodiment of the invention;

(10) FIG. 9 is a schematic side view of a hand held corneal ink applicator according to an example embodiment of the invention;

(11) FIG. 10 is a schematic side view of a hand held corneal ink applicator including a mirror to facilitate self application according to an example embodiment of the invention;

(12) FIG. 11 is a schematic side view of a hand held corneal ink applicator including a camera or cell phone camera to facilitate self application according to an example embodiment of the invention; and

(13) FIG. 12 is a flow chart depicting a method according to an example embodiment of the invention.

(14) While various embodiments are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the claimed inventions to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the claims.

DETAILED DESCRIPTION

(15) Referring to FIG. 1, a prior art pinhole type corneal inlay 20 is depicted. Pinhole type corneal inlay 20 includes annular disk 22, and central circular aperture 24. Pinhole type corneal inlay 20 also presents multiple microapertures 26 in annular disk 22. Microapertures 26 are understood to be transparent spaces in annular disk 22.

(16) Referring to FIG. 2, pinhole type corneal inlay 20 is depicted as implanted in cornea 28. It is noted that this is a schematic depiction and the layers of the cornea as well as the specific depth of implantation are not necessarily depicted in FIG. 2.

(17) Referring now to FIG. 3, annular inked area 30 surrounding central circular aperture 32 is depicted.

(18) Referring also to FIG. 4, it is notable that annular inked area 30 according to the present invention is located on the corneal epithelial surface 34. Annular inked area 30 is created by the application of surgical ink applied to corneal epithelial surface 34 according to embodiments of the invention.

(19) Referring now to FIG. 5, corneal ink applicator 36, according to an example embodiment of the invention, is depicted. Corneal ink applicator 36 generally includes applicator body 38 having applicator tip 40. Applicator tip 40 generally presents ink reservoir portion 42 and ink resist portion 44. In the depicted embodiment, applicator body 38 further includes tonometer coupling portion 46 including coupling barrel 48. Coupling barrel 48 is sized to match a similar portion of a Goldmann tonometer prism in order that applicator 38 may be placed in a Goldmann tonometer which is commonly available in the offices of eye doctors and used for measuring intraocular pressure.

(20) Ink reservoir portion 42 is formed of a material adapted to absorb and release ink. For example, ink reservoir portion may include a porous, rubber or foam material as well as a ground glass surface.

(21) Ink resist portion 44 is glossy and smooth and formed of a material that resists the absorption and release of ink. Ink resist portion 44 may also include a cavity or space. Referring to FIG. 6, corneal ink applicator 36 is schematically depicted as coupled to a Goldmann tonometer 50 and in contact with schematically depicted cornea 28.

(22) According to an example embodiment, ink reservoir portion 42 has an outside diameter between about 3.2 and 4.4 mm. According to a further example embodiment, ink reservoir portion 42 has an outside diameter of approximately 3.6 mm. According to another example embodiment, ink resist portion 44, located centrally in ink reservoir portion 42, has a diameter between about 1.0 and 2.2 mm. According to a further example embodiment, ink resist portion 44 has a diameter of 1.8 mm.

(23) Referring now to FIG. 7, another example embodiment of corneal ink applicator 36 is depicted. In the depicted embodiment, corneal ink applicator 36 includes slit lamp coupling portion 52. Slit lamp coupling portion 52 generally includes corneal applicator holding member 54 and slit lamp engaging member 56 which are adapted to couple corneal ink applicator 36 to slit lamp biomicroscope 58. Slit lamp engaging member 56 may be coupled to slit lamp biomicroscope 58 in a number of ways including ways similar to which a Goldmann tonometer is coupled to slit lamp biomicroscope 58. Slit lamp engaging member 56 may engage a microscope head (not shown) of slit lamp biomicroscope 58 or may engage slit lamp biomicroscope 58 at or near the slit lamp vertical rotational axis in a similar fashion to a focusing rod commonly used with slit lamp microscope 58.

(24) Referring to FIG. 8, well corneal ink applicator 60 according to another example embodiment of the invention is depicted.

(25) In the depicted example embodiment, well corneal ink applicator 60 generally includes peripheral ring portion 62, central ink resist portion 64, ink resist support 66, ring support 68, and well handle 70. Peripheral ring portion 62 is coupled to ring support 68 which is in turn coupled to well handle 70. Central ink resist portion 64 is coupled to ink resist support 66 which is in turn coupled to well handle 70. Central ink resist portion 64 is separated from peripheral ring portion 62 by intervening space 72. Intervening space 72 is generally annular in shape. In the depicted embodiment, central ink resist portion 64 is generally circular in shape and centrally located within peripheral ring portion 62. Peripheral ring portion 62 may be formed of a biocompatible material such as surgical stainless steel, nitinol or a polymer material. Central ink resist portion 64 may be formed of a similar biocompatible material. Central ink resist portion 64 further includes ink resist disk 74 coupled to ink resist support 66. Ink resist disk 74 may be surfaced with a hydrophobic material such as a fluoropolymer for example Teflon®. Ink resist disk 74 may further include sealing rim 76. Peripheral ring portion 62 includes sealing edge 78 at a lower edge thereof.

(26) Referring now to FIG. 9, hand held ink application device 80 is depicted. Hand held ink application device 80 includes a structure similar to corneal ink applicator 36 as well as holder portion 82. Corneal ink applicator 36 is coupled to holder portion 82 so that holder portion 82 may be held in the hand of an eye care professional making the ink application. Holder portion 82 or corneal ink applicator 36 may also include a fixation target 84 visible to the patient to assist in application.

(27) Referring now to FIG. 10, hand held ink application device 80 may further include mirror 86 coupled thereto. Mirror 86 facilitates self application of corneal inking. Mirror 86 is depicted as a plano mirror. However, mirror 86 may also include a concave mirror to assist in visualizing the application process with magnification.

(28) Referring now to FIG. 11, hand held ink application device 80 may also include cell phone or camera coupler 88. Cell phone or camera coupler 88 is adapted to provide physical connection 90 and data connection 92 to digital camera or cell phone 94. Digital camera or cell phone 94 is thus physically and data connected to cell phone or camera coupler 88 in such a way to provide an image for self application of surgical ink to corneal epithelial surface 34.

(29) Referring now to FIG. 12, a method according to another example embodiment of the invention is depicted.

(30) The example method includes identifying a patient desiring to consider a pinhole corneal inlay S10; applying surgical ink to a central portion of the corneal epithelium of the patient in an annular pattern surrounding a central uninked portion letter S12; wherein the annular pattern and the central uninked portion have a center point S14.

(31) According to another example embodiment of the invention, the method includes locating the center point on the visual axis of the eye S16.

(32) According to another example embodiment, the method includes locating the center point along an axis coinciding with a center of the pupil of the eye S18.

(33) According to another example embodiment, the method includes applying the surgical ink such that the central uninked portion has a diameter of between 1.0 and 2.2 mm S20.

(34) According to a further example embodiment, the method includes applying the surgical ink such that the central unlinked portion has a diameter of 1.6 mm S22.

(35) According to a further example embodiment, the method includes applying the surgical ink such that the annular pattern has an outside diameter of between 3.2 and 4.4 mm S24. According to a further example embodiment, the method includes applying the surgical ink such that the annular pattern has an outside diameter of 3.6 mm S26.

(36) According to yet another example embodiment, the method includes applying the surgical ink to an anterior surface of the corneal epithelium S28.

(37) According to a further example embodiment, the method includes applying the surgical ink to a lenticle that has been surgically removed from the cornea S30. According to this embodiment, the surgical lenticle may be further reinserted into the cornea S32. Further according to this embodiment, the surgical lenticle may be stored for a period of time and reinserted into the cornea later S34.

(38) Various embodiments of systems, devices, and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the claimed inventions. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, configurations and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the claimed inventions.

(39) Persons of ordinary skill in the relevant arts will recognize that the subject matter hereof may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter hereof may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the various embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted.

(40) Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended.

(41) Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein.

(42) For purposes of interpreting the claims, it is expressly intended that the provisions of 35 U.S.C. § 112(f) are not to be invoked unless the specific terms “means for” or “step for” are recited in a claim.

(43) The present invention may be embodied in other specific forms without departing from the spirit of the essential attributes thereof; therefore, the illustrated embodiments should be considered in all respects as illustrative and not restrictive, reference being made to the appended claims rather than to the foregoing description to indicate the scope of the invention.