Device and Method for Axis Marking

Abstract

A method and device is provided for forming discernable markings within the cornea of an eye. Using a lens having a focal length to communicate and focus a laser to a focal point within the corneal layer of an eye, temporary markings can be formed within the corneal layer below its exterior surface. So formed the markings will remain for a number of days and provide the surgeon the ability to use the markings during eye surgery.

Claims

1. A method for forming discernable markings within the cornea of an eye, comprising the steps of: positioning a lens having focal length to converge a laser communicating therethrough, to a focal point within the corneal layer of the eye, adjacent a surface of the cornea of said eye; and communicating a laser beam through said lens to thereby form a marking at said focal point of said lens, within the corneal layer of the eye.

2. The method according to claim 1 further comprising the steps of: positioning said lens having a said focal length defining a said focal point which is in a range between 40 to 450 microns below said surface of said cornea.

3. The method according to claim 2, further comprising the steps of: positioning a plurality of said lenses to form a plurality of markings within said corneal layer.

4. An apparatus for forming discernable markings in an eye, comprising: a lens carrier, said lens carrier having at least one lens therein; said lens carrier adapted for positioning to a used position, adjacent the surface of a corneal layer of an eye; said lens having focal length configured to converge a light communicating therethrough, to a focal point within said corneal layer a distance below said surface of said corneal layer; and a YAG laser, said YAG laser positionable to communicate a laser beam through said lens to said focal point, whereby a marking is formed by said laser beam at said focal point.

5. An apparatus for forming discernable markings in an eye of claim 4, additionally comprising: said lens carrier having a plurality of lenses positioned therein, wherein a plurality of said markings are formed within said corneal layer.

6. An apparatus for forming discernable markings in an eye of claim 4, wherein said lens has a said focal length configured to converge a said light communicating therethrough, to a said focal point within said corneal layer in a range from 40 to 450 microns below said surface of said corneal layer of said eye.

7. An apparatus for forming discernable markings in an eye of claim 5, wherein each said lens has a said focal length configured to converge a said light communicating therethrough, to a said focal point within said corneal layer in a range from 40 to 450 microns below said surface of said corneal layer of said eye.

8. The apparatus for forming discernable markings in an eye of claim 4 wherein said lens carrier has a connection thereon, said connection adapted to engage with a distal end of a handle.

9. The apparatus for forming discernable markings in an eye of claim 5 wherein said lens carrier has a connection thereon, said connection adapted to engage with distal end of a handle.

10. The apparatus for forming discernable markings in an eye of claim 6 wherein said lens carrier has a connection thereon, said connection adapted to engage with a distal end of a handle.

11. The apparatus for forming discernable markings in an eye of claim 4 additionally comprising: said lens carrier rotationally engaged within an outer ring; said lens rotatable to differing positions adjacent said surface of said corneal layer of said eye, by a rotation of said lens carrier within said outer ring.

12. The apparatus for forming discernable markings in an eye of claim 5 additionally comprising: said lens carrier rotationally engaged within an outer ring; said lens rotatable to differing positions adjacent said surface of said corneal layer of said eye, by a rotation of said lens carrier within said outer ring.

13. The apparatus for forming discernable markings in an eye of claim 6 additionally comprising: said lens carrier rotationally engaged within an outer ring; said lens rotatable to differing positions adjacent said surface of said corneal layer of said eye, by a rotation of said lens carrier within said outer ring.

14. The apparatus for forming discernable markings in an eye of claim 7 additionally comprising: said lens carrier rotationally engaged within an outer ring; each of said plurality of lenses being rotatable to differing positions adjacent said surface of said corneal layer of said eye, by a rotation of said lens carrier within said outer ring.

15. The apparatus for forming discernable markings in an eye of claim 11 additionally comprising: said outer ring having a connection thereon, said connection adapted to engage a distal end of a handle.

16. The apparatus for forming discernable markings in an eye of claim 12 additionally comprising: said outer ring having a connection thereon, said connection adapted to engage a distal end of a handle.

17. The apparatus for forming discernable markings in an eye of claim 13 additionally comprising: said outer ring having a connection thereon, said connection adapted to engage a distal end of a handle.

18. The apparatus for forming discernable markings in an eye of claim 14 additionally comprising: said outer ring having a connection thereon, said connection adapted to engage a distal end of a handle.

Description

BRIEF DESCRIPTION OF DRAWING FIGURES

[0042] The accompanying drawings, which are incorporated herein and form a part of the specification, illustrate some, but not the only nor exclusive examples of embodiments and/or features of the disclosed device. It is intended that the embodiments and figures disclosed herein are to be considered illustrative of the invention herein, rather than limiting in any fashion.

[0043] In the drawings:

[0044] FIG. 1 depicts the general steps of the method herein using a targeting instrument with a lens or lenses, in combination with a YAG laser, for forming discernable markings submerged in the corneal layer of the eye tissue of a patient.

[0045] FIG. 2 displays a depiction of an eye treated with the method herein, wherein at least one marking has been formed by and into the corneal layer thereof using the method and/or the instruments herein.

[0046] FIG. 2a, shows another depiction of an eye, where a plurality of markings are formed within the corneal layer of the eye, in radial positions defining an axis.

[0047] FIG. 2b depicts a sectional illustration of an eye, showing the formation of indicia defining markings within the corneal layer of the eye, below the surface.

[0048] FIG. 3 shows one mode of the instrument enabling the method herein, wherein a focusing lens is engaged to the distal end of a handle and is positionable over target positions of the eye to focus laser energy therethrough to form markings into the underlying eye tissue of the cornea below the surface.

[0049] FIG. 4 depicts a view of a mode of an instrument employable for imparting markings into the corneal layer of an eye showing a rotatable interior ring engaged to the interior circumference of an exterior ring engaged to a handle.

[0050] FIG. 5 is a sectional view through the instrument of FIG. 4 showing the clear plastic section which houses one or a plurality of lenses.

[0051] FIG. 6 depicts another mode of the instrument similar to that of FIG. 4 but having a plurality of aligned lenses communicating through the material forming the rotatable interior ring which will form markings within the corneal layer of tissue similar to those of FIG. 2a.

[0052] FIG. 7 shows a sectional view through the instrument of FIG. 6 depicting the aligned plurality of lenses.

[0053] FIG. 8 depicts a mode of the instrument herein having a targeting component engageable with a handle, and showing a plurality of lenses therein which focus the laser between 40 to 450 microns below the surface of the cornea.

[0054] FIG. 9 shows the device of FIG. 8, and also includes an optional bubble level for use during positioning upon or adjacent the eye of the patient.

[0055] FIG. 10 shows a mode of the device, wherein the lens focusing the layer below the surface of the cornea, is centered, and would be moved to position by the user.

[0056] FIG. 11 depicts a sectional view through the lens of FIG. 10.

[0057] FIG. 12 shows a targeting component adapted for engagement to a handle such as in FIG. 10, wherein the central portion is empty and has a bubble level positioned therein, and a plurality of lenses is positioned about the perimeter.

[0058] FIG. 13, is an example of one mode of a lens which is configured to make a focal point of the laser 0.3 mm or 300 microns below the surface of the cornea.

DETAILED DESCRIPTION OF THE INVENTION

[0059] Now referring to drawings in FIGS. 1-13, wherein similar components are identified by like reference numerals, there is seen in FIG. 1, the steps in the method 10 herein disclosed for imparting markings into the cornea between 40-450 microns below the surface thereof. The formed temporary markings are subsequently employable for implanted lens orientation and will not move or erase for substantially two days.

[0060] In all modes of the method, at least one lens 16 for targeting the laser is positioned adjacent or upon the eye of the patient in a position where a marking 12 is desired. Once so positioned, in a next step, a YAG laser or other directed energy device is communicated through the targeting lens 16 and is focused to a focal point between 40 and 450 microns, below the surface of the cornea, within the corneal layer of the eye. The laser communicating through the lens 16 forms the markings 12 at the depth of and in a position within the cornea, determined by the lens 16 and its position on or adjacent the eye.

[0061] As noted, the formed markings 12, are temporary, but will be positioned viewable within the cornea, for substantially two days, so they are not subject to erasure or movement.

[0062] In a preferred mode of implementation, at least one marking 12 is formed into the corneal layer of the eye 14, as shown in FIG. 2, using the targeting instrument herein having at least one lens 16 configured to target the location of communication of the laser into the corneal layer of the eye. Multiple markings 12 may also be employed. While various devices are shown herein to accomplish this method, others are possible and considered within the scope of this application so long as they employ the method herein, of positioning markings 12 within the cornea between 40 to 450 microns below the surface thereof.

[0063] Markings 12 formed in the cornea are shown in FIGS. 2-2b herein. As shown in FIG. 2, an eye 14 is depicted which has been treated with the method 10 herein. As shown in FIG. 2, at least one marking has been formed by and into the corneal layer and is visible. Shown in FIG. 2a is another depiction of an eye 14, where a plurality of markings 12 are formed within the corneal layer of the eye 14, in radial positions.

[0064] In FIG. 2b, there is seen a sectional illustration of an eye 14. The marking 12 shown, as with all markings 12 formed in the method herein, is formed within the layer of the cornea 13, between 40 to 450 microns, away from or below the surface thereof. Also shown, as a frame of reference, are the eye lens 19, the area of the eye 14 of the iris 21, and the eyelids 23.

[0065] FIG. 3 shows one mode of the instrument for the method 10 herein wherein a glass or plastic lens 16 is engaged to the distal end of a handle 18 and is positionable to place the lens 16 over determined target positions of the eye 14. So positioned, the lens 16 has surfaces formed to focus the beam of laser energy therethrough to a focal point below the surface of the cornea 13 to form markings 12 into the underlying eye tissue. The lens 16 can be ground or formed to an exact focal point within the cornea 13 in the noted range, taking into consideration the distance from the lens 16 of the laser. An example of such a formation yielding a focal point 300 microns below the surface of the cornea 13 is depicted in FIG. 13. However, such focal point lens formation is well known and the lens 16 configuration can be changed to form a focal point anywhere between 40 to 450 microns below the surface of the cornea 13, and such is anticipated within the scope of this patent.

[0066] Another mode of an instrument having a lens 16 employable for imparting markings to the tissue of an eye 14 is depicted in FIGS. 4 and 5. As shown, a carrier is formed for the lens 16 by a rotatable ring 22 which is engaged to the interior circumference of an exterior ring 24 engageable to a handle 18. An aperture 26 is positioned in a center of the lens carrier formed by the ring 22 for use during alignment with the pupil of the eye 14.

[0067] A lens 16 communicates through the plastic or metallic material forming the lens carrier shown as the ring 22. The lens is rotatable by rotation of the ring 22 to position it in the desired target position for communication of a yag laser or other directed energy device adapted for forming the markings 12 into eye tissue. Indicia showing degrees is radially positioned around the surface of the exterior ring 24. In another step in the method 10 herein, an LED or other light source (not shown) may be employed during targeting of the lens 16 or lenses 16 herein, to determine the contact point of the light through the lenses on exterior of the cornea, prior to communication of laser energy to form the marking 12 below the surface of the cornea 13 and make the mark 12 on the targeted position.

[0068] Shown in FIG. 6, is a mode of the instrument similar to that of FIG. 4. The instrument of FIG. 6 is shown having a plurality of lenses 16 communicating through the carrier formed by the material of the rotatable ring 22. The plurality of lenses 16 may be in a single group or multiple groups of lenses 16 as shown or in a plurality of singular lenses 16 communicating in different positions through the ring 22 which would form a line of markings.

[0069] As with the instrument of FIG. 4, the instrument of FIG. 6 preferably has the lens carrier shown as the ring 22 rotationally engaged with the exterior ring 24 so that it may be rotated and the lens 16 or lenses 16 thereby may be positioned adjacent degree markers radially positioned on the surface of the exterior ring 24, to determine the targeted positions for the markings 12.

[0070] The YAG laser or a similar directed energy device is employed subsequent to the final positioning of the lens 16 or lenses 16. By communication of a YAG laser beam therethrough, the formation of the fixed positioned temporary markings 12 within the layer of the cornea 13, at a depth and position targeted by the focal point of the lens 16.

[0071] These marks or markings 12 are visually discernable for adjustment or alignment of an implanted lens. As noted above, in a step of the method 10, and in combination with the devices herein, an LED or other light emitting device might first be employed to communicate a light beam through the lens 16 first, to ascertain the focal point of a lens 16 on the exterior surface of the cornea 13, to aid in placing the lenses 16 in determined targeting positions for placement of subsequent marks.

[0072] As noted, in all modes of the instrument with rotatable lenses 16, the lens carrier or ring 22 may be removably engageable with the exterior ring 24 to allow removal and replacement thereof with a chosen ring 22 having the chosen lens 16 or lenses 16 positioned therein, of a diopter and in positions adapted to form the markings 12 at the desired depth in the cornea 13 layer.

[0073] Thereafter, the ring 22 may be removed and replaced with another adapted for engagement within the interior circumference of the exterior ring 24. In this manner the lens carrier provided by the rings 22 may be provided in sterile packaging and in and infinite number of lens configurations, number, and positionings configured to form the markings 12 which are adapted to allow for alignment and adjustment of an implanted lens subsequently implanted in the eye of a patient having the markings 12 thereon.

[0074] Shown in FIG. 8, is Amode of the instrument employable for the method 10 herein, having a lens carrier, engageable with a handle, and showing a plurality of lenses 16 therein which focus the laser between 40 to 450 microns below the surface of the cornea.

[0075] FIG. 9 shows the device of FIG. 8, and also includes an optional bubble level 25 for use during positioning of the carrier provided by the ring 22 and lens 16 upon or adjacent the eye 14 of the patient. As shown, the ring 22 is engaged or engageable with the distal end of a handle 18. A aperture 26 forming an open area in the center of the ring 22 has a bubble level 25 therein.

[0076] In FIG. 10 is depicted another mode of the instrument employable with the method 10 herein. As shown, the lens 16 for focusing of the laser to form the marking 12 below the surface of the cornea 13, is formed centrally within the ring 22 providing a lens carrier. In this mode, the lens 16 is moved to the area of the cornea 13 generally outside the pupil or over the iris, whereupon the laser is employed to form the marking 12 between 40 to 450 microns from the surface of the cornea 13 but within the layer formed by the cornea 13.

[0077] The ring 22 is shown as having a connection 28 thereon adapted to engage the distal end of a handle 18 to allow for engagement of any of a plurality of rings 22 having one or a plurality of lenses 16 positioned to form the marking 12 or markings 12 desired in the cornea 13 layer. A sectional view of the ring 22 is shown in FIG. 11.

[0078] Shown in FIG. 12 is another mode of the instrument herein showing the lens carrier provided by the ring 22 having a plurality of four lenses 16 therein and an aperture 26 communicating through the center. A bubble level 25 is shown positioned in the aperture 26, and a connection 28 is provided which is adapted to engage the distal end of a handle 18 of choice.

[0079] Finally, shown in FIG. 13, is an example a construction of a lens 16, which is configured to form a focal point of the laser below the surface of the cornea 13 and within the layer formed by the cornea 13. As shown, a lens 16 is configurable to cause the laser communicated therethrough, to have a focal point at substantially 0.3 mm or 300 microns, below the surface of the cornea 13, and within the layer of the cornea 13. A current particularly favored position for the marking 12 within the layer of the cornea 13 is between 200 to 400 microns below the exterior surface of the cornea 13 as such has shown to provided laser-formed markings 12 which are especially easy to view and discern.

[0080] Using lens grinding calculations which are well known, this focal point may be adjusted and in the method 10 herein, a lens 16 configured to position the focal point of the laser between 40 to 450 microns below the exterior surface of the cornea 13, and thereby form the temporary markings 12 at that position in the corneal layer 13 is preferred to place the markings 12 in position in the corneal 13 layer, where they are viewable by the physician, but where they cannot be accidentally removed or shifted.

[0081] As noted, any of the different configurations and components shown herein, can be employed with any other configuration or component shown and described herein. Additionally, while the present invention has been described herein with reference to particular embodiments thereof, and steps in the method, a latitude of modifications, various changes and substitutions are intended in the foregoing disclosures, it will be appreciated that in some instance some features, or configurations, or steps in formation of the invention could be employed without a corresponding use of other features without departing from the scope of the invention as set forth in the following claims.

[0082] All such changes, alternations and modifications as would occur to those skilled in the art are considered to be within the scope of this invention as broadly defined in the appended claims.

[0083] Further, the purpose of any abstract of this specification is to enable the U.S. Patent and Trademark Office, the public generally, and especially the scientists, engineers, and practitioners in the art who are not familiar with patent or legal terms or phraseology, to determine quickly from a cursory inspection the nature and essence of the technical disclosure of the application. Any such abstract is neither intended to define the invention of the application, which is measured by the claims, nor is it intended to be limiting, as to the scope of the invention in any way.