APPARATUS AND METHOD FOR CORNEAL MARKING
20180303668 ยท 2018-10-25
Assignee
Inventors
Cpc classification
International classification
Abstract
A corneal marking system, and methods for its use, has a tilt-detecting device attached to a corneal marker, adapted to produce a signal when the corneal marker is in a horizontal position. Use of measurement devices may be coordinated between the marker and a level-measuring device positioned on a patient's head. Devices capable of measuring one, two or three axes are used and processors are provided to evaluate the data produced by the devices and provide a physician with a signal that the positions of the patient's head and the marker are such that an accurate marking procedure can be performed.
Claims
1. A marking apparatus for marking a cornea of a patient, said marking apparatus comprising: a handle having a proximal end and a distal end; a mounting platform attached to said handle distal end; a tilt detector attached to said mounting platform for detecting a spatial orientation of said marking apparatus with respect to a selected datum, said tilt detector configured to indicate the orientation of said marking apparatus; wherein said tilt detector is an electronic level sensor having at least one light provided thereon to indicate the spatial orientation of said marking apparatus with respect to a selected datum, said electronic level sensor and said at least one light carried on said mounting platform; a corneal marker attached to said platform for marking said cornea, said corneal marker configurable to be located at a selected orientation with respect to said selected datum.
2. The marking apparatus as recited in claim 1 wherein said selected datum is a true horizontal plane.
3. (canceled)
4. (canceled)
5. The marking apparatus as recited in claim 1 wherein said at least one light of said electronic level sensor is configured to produce visual signals as said electronic level sensor moves with respect to said datum.
6. The marking apparatus as recited in claim 1 wherein said electronic level sensor has an audible signal-generator configured to produce characteristic audibly-detectable signals as said electronic level sensor moves with respect to said datum.
7. The marking apparatus as recited in claim 1 wherein said handle and said platform meet at an angle.
8. The marking apparatus as recited in claim 1 wherein handle and said corneal marker meet at an angle.
9. The marking as recited in claim 1 wherein said platform is positioned intermediate said corneal marker and said handle.
10. The marking apparatus as recited in claim 1 wherein said handle is configured to form a grip intermediate said proximal and distal ends.
11. The marking apparatus as recited in claim 1 wherein said datum is selected from at least one of an x-axis; a y-axis; and a z-axis.
12. The marking apparatus as recited in claim 11 further comprising: a summarizer configured to compare the orientation of said marking apparatus with respect to said at least one axis to a table of calculated values; and said summarizer further configured to generate at least one of an audio and a visual signal when the orientation of said marking apparatus meets a predetermined threshold with respect to said table of calculated values.
13. The marking apparatus as recited in claim 12 wherein said summarizer comprises a computer program.
14. The marking apparatus as recited in claim 12 wherein said at least one of an audio and a visual signal varies in response to a comparison of the orientation of said marking apparatus to said table of calculated values.
15. The marking apparatus as recited in claim 1 further comprising: a focusing lamp positioned on said marking apparatus for being viewed by a patient when said apparatus is in a position to mark a cornea of the patient.
16. (canceled)
17. (canceled)
18. (canceled)
19. (canceled)
20. (canceled)
21. (canceled)
22. (canceled)
23. (canceled)
24. A method for marking the cornea of a patient, said method comprising the steps of: (a) obtaining the marking apparatus of claim 1; (b) positioning a patient to mark a cornea of the patient; (c) manipulating said marking apparatus until said tilt detector indicates the orientation of said marking apparatus; and (d) bringing said marking apparatus into contact with the cornea to create a mark on the cornea.
25. The method of claim 24 further including the step of: selecting said datum to be a true horizontal plane.
26. The method of claim 24 further including the step of: activating a focusing lamp on said marking apparatus to focus the eye of the patient on said lamp.
27. (canceled)
28. (canceled)
29. (canceled)
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] These and further objects of the present invention will become more apparent upon considering the accompanying drawings in which:
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DETAILED DESCRIPTION OF THE DRAWINGS
[0062] Referring now to
[0063] A third marking tab 34 is formed integral with upper surface 18 and midway along blade 16 between first and second marking tabs 22, 24. Tab 34 has an upper marking edge 36. A fourth marking tab 38 having a lower marking edge 40 extends from lower surface 20 opposite third marking tab 34.
[0064] While the marking tabs 22, 24, 34 and 38 are shown in
[0065] Referring now to
[0066] Attached to fork 48 is a combined gauge and keratometer assembly 50. As best seen in
[0067] Gauge ring 52 has a central circular aperture 56 formed therethrough. An inner toroidal marker ring 58 is rotatably fitted to gauge ring 52 through aperture 56. Ring 58 has a first right circular segment 60 held rotatably within the gauge ring 52 with first segment 60 extending above upper gauge ring surface 54. A reference mark 62 is engraved on ring 58.
[0068] Referring now to
[0069] A keratometer ring 78 is attached to inner wall 80 of marker ring 58 by ring shaft 82. When axis marker 42 is placed on a patient's cornea, light from the operating microscope is directed through keratometer ring 78 and will highlight the general shape of any astigmatism in the cornea. This is not intended as a precise identification of the position of the steep axis of the cornea, but is intended to provide a backup indicator to confirm to the surgeon that the previously obtained keratometer readings were correct in identifying the steep axis.
[0070] In use, marking tabs 74, 76 are coated with a suitable dye and marker ring 58 is rotated to bring reference mark 62 in alignment with the scale scribed on surface 54 to coincide with the angle of the previously-measured steep axis. Non-rotating markers 70, 72 are then coated with a suitable dye. The instrument is then placed on the eye to bring one of the non-rotating tabs 70, 72 at the corner of the eye such that tabs 74, 76 are in alignment with the steep axis. Tabs 74, 76 are then pressed against the cornea to leave a pair of marks that allow the surgeon to align the IOL along the steep axis after insertion.
[0071] As shown in
[0072] Referring now to
[0073] It is to be understood that keratometer assembly 90 is assembled and functions generally in accordance with the foregoing descriptions of keratometer assemblies having rotating index rings and having marking tabs formed on the rotating and non-rotating portions of the assembly. In the view shown in
[0074] A tilt detector mount 100 is attached to handle 86 intermediate throat 88 and handle end 102.
[0075] Referring now to
[0076] As tilt detector 104 is inclined with respect to the horizontal, various of the LEDs 106, 108, 110, 112, and 114 will sequentially light up to identify the orientation of tilt detector 104 and thereby handle 86. For example, if handle 86 is inclined to the right with keratometer assembly 90 being higher than handle end 102, LEDs 106, 108 will be illuminated. In similar fashion, if marker 84 is tilted such that keratometer assembly 90 is lower than handle end 102, LEDs 112, 114 will be illuminated. When center LED 110 is illuminated, handle 86 is in a horizontal position and reference marks 116, 118 are aligned vertically.
[0077] Tilt detector 104 is of the type that can also emit a characteristic sound when it is level and LED 110 is lit, or to warn when it is not level. Such detectors can thus provide both visual and auditory signals to indicate various stages of alignment.
[0078] Use of corneal marker 84 is enhanced when the patient's head is positioned so that the patient's eyes are horizontally level.
[0079] Referring now to
[0080] In use, headband 122 is placed around the patient's forehead as the patient is in a seated position. The patient's head is moved to produce a signal that the headband and, thereby, the patient's head are in a position to horizontally level the patient's eyes.
[0081] Corneal marker 84 is placed near the eye to be marked and handle 86 is inclined until a level signal is produced by tilt detector 104. When both tilt detectors 104, 124 produce level signals then keratometer assembly 90 is correctly oriented to mark the patient's eye.
[0082] Referring to
[0083] A communication pathway 142 extends between devices 132 and 136. Pathway 142 may consist of an electrically conductive wire and may also indicate a pathway created wirelessly by broadcast and receiving circuits provided in tilt detectors 132, 136.
[0084] Tilt detectors 132, 136 are adapted to communicate to each other and to indicate the degree to which each is inclined with respect to a selected reference. In the most common case, the selected reference will be the horizontal direction. Using the arrangement of
[0085] Referring now to
[0086] Using such an arrangement, signal detector 154 can audibly, visually, or a combination thereof, indicate when tilt detectors 148, 152 are held in identical orientations with respect to a selected reference. As described above, communication passageway 156, 158 can be wired or wireless.
[0087] As seen in
[0088] It is also contemplated that a tilt detector constructed to withstand the sterilization process can be mounted in the handle itself.
[0089] If it is desired to keep patient distractions to a minimum when using the audible signal to verify alignment the signal can be set to broadcast to a set of headphones or an earpiece. The readings of both the corneal marker and the headband can be stored in a computer to make a full record of the patient's procedure for later review.
[0090] In use, the patient is first fitted with a headband constructed in accordance with the foregoing. Where there is a preset inclination, the patient is assisted to reach a head position where the preset is met as indicated by the signal generated by the tilt defector mounted on the headband. Next, a corneal marker, constructed as set forth herein, is selected, having a tilt detector with a preset inclination matching that of the headband. The corneal marker is adjusted to produce a signal confirming that the headband and the corneal marker are both aligned to the same preset inclination and the marking of the cornea is then carried out.
[0091] Where there is no preset inclination, the headband tilt detector and the corneal marker tilt detector are set to emit a signal when both are aligned to the same inclination. Once this signal is produced corneal marking can proceed. In this manner, even if the patient's head moves, an accurate reading will still be obtainable.
[0092] Referring now to
[0093] Referring now to
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[0095] As seen in
[0096] Referring now to
[0097] Referring to
[0098] Referring now to
[0099] Referring now to
[0100] As seen in
[0101] Referring now to
[0102] Referring now to
[0103] Referring to
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[0105] Referring to
[0106] Any number of marking blades can be used on any of the keratometers described herein, as desired. Individual marking blades on each of the keratometer assemblies may be inked or not inked to provide a desired number of reference marks on the cornea for surgical purposes.
[0107] While electronic levels 166, 210 have been described as providing visual indicators such as LEDs to indicate when the device is level it should be understood that audible signals can be produced as well, with different sounds indicating left-right-level attitudes. Thus, a surgeon can determine correct positioning of the corneal marker either visually, audibly, or both.
[0108] In another embodiment of the present invention, a more fully featured apparatus is provided for detecting the orientation of a patient's head in one, two or three directions, and in some instances, correlating the measured orientation of the patient's head with a marking instrument.
[0109] Referring now to
[0110] Frame 238 has a cross-bar 240 to which eyepieces 242, 244 are attached. A pair of temples 246, 248 are attached respectively to eyepieces 242, 244 respectively, allowing a patient to wear trial frame 238 in the same manner as a pair of eyeglasses.
[0111] In the example shown in
[0112] Referring now to
[0113] In use, a patient puts on frame 238 as though it were a pair of glasses and, during the patient's examination, the attitude of the patient's head with respect to the horizontal is adjusted by visually viewing spirit levels 250, or 256 and 258. When the patient's head is horizontally level, the steep angle can then be measured more accurately as described hereinabove.
[0114] As described above, an electronic level such as 186 or 210 can be substituted for the spirit levels in the foregoing embodiments.
[0115] It is possible to measure the orientation of a patient's head in more than one axis or direction. For example, it may be desirable to measure the horizontal inclination of the patient's head as has been discussed heretofore, and also measure the tilt forward or back of the patient's head. Likewise, it may also be desirable to measure the height of the patient's head above a given datum such as the floor or the chair seat in which the patient is seated. To do so would require a leveling device with broader or expanded capabilities.
[0116] Referring now to
[0117] Referring to
[0118] Referring now to
[0119] Use of leveling devices such as 268 and 278 allows the measurement of a patient's head orientation in one, two or three directions. For the purposes of this description, the x-axis is the measure of the horizontal attitude of the patient's head as described hereinabove. It is possible to construct electronic levels 268 and 278 such that the tilt of the patient's head perpendicular to the frame, that is, in a nodding position can be separately detected. For the purposes of this description this will be referred to as the z-axis. The distance of the patient's head may be measured along the y-axis.
[0120] Leveling devices 268 and 278 can then correlate this data to a visual or audio signal. For example, indicator light arrays 274,284 and 286 may be programmed to illuminate in a first selected color or make a first sound when a desired alignment of the patient's head has been reached along the x-axis, a second color or sound when the y-axis measurement reaches a desired value and a third sound or color with respect to measurements along the z-axis.
[0121] As an example, an indicator light flashing red can indicate the attitude of the patient's head in the x-axis direction while an indicator light flashing orange can indicate the position of the patient's head in the z-axis direction. It would then be possible for the examining physician to determine in what position the patient's head would be in the x-axis direction and subsequently in the y-axis direction.
[0122] It is also contemplated that the signals generated to activate the individually colored lights can be processed through an analog summarizer to produce an indicator or signal that the patient's head is aligned sufficiently in the x-, y-, and/or z-axis directions to meet the physician's criteria for accurate toric marking. The analog summarizer can be a computer program maintained on a computer or computer network with which the generated signals can be transmitted in a wired or wireless manner.
[0123] The summarizer can also be programmed onto a computer-readable card such as a CF card or SD card. A card reader can be built into a leveling device such as device 268 and later removed for data processing and storage.
[0124] Referring now to
[0125] The numeral 296 indicates a data point at which both the x- and y-axis measured values are ideal. At that point a green light signal is displayed and the physician knows that accurate toric marking can occur. In practice, data point 296 can represent a set of data points that, when achieved, allows marking to be carried out at an acceptable accuracy level.
[0126] Use of electronic levels 268 and 278 on both the toric marker and the trial frame can be made in much the same manner as described above in connection with
[0127] Signals generated by electronic levels 298 and 300 are transmitted to a signal processor 302 within which analyses are carried out by a signal summarizer programmed to respond by activating a series of visual or aural displays (or both) to inform the physician of the spatial orientation and positioning of each electronic level individually and to compare the values of each to determine when both are in a position within a selected data set to produce an acceptable marking of the patient's eye. As an example, red and orange signals, as described above, with provide cues to positional adjustments while a single green signal can indicate that the physician may proceed with the marking. The signals may be stored as part of the patient's records for later review.
[0128] While the foregoing examples have described particular types of frames suitable for use with mechanical or electronic attitude-detecting and measuring devices, such is use is not limited to any specific type of frame. Use of trial frames may be particularly apt because such frames can be used to measure other characteristics of a patient's eye in, for example, an operating room where larger and more conventional apparatus may not be appropriate.
[0129] The various types of mechanical and electronic attitude measuring devices uses in the foregoing examples are commonly and commercially available and are readily adaptable to be used to measure in one, two or three axes.
[0130] Referring now to
[0131] As seen in