Surgery – Instruments – Light application
Reexamination Certificate
2002-06-27
2004-11-09
Shay, David M. (Department: 3739)
Surgery
Instruments
Light application
C606S005000
Reexamination Certificate
active
06814729
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention is generally directed to the field of laser vision correction, and more particularly, to laser vision correction systems and control apparatus and methods.
2. Description of Related Art
Ultraviolet laser systems and related methods are known for enabling ophthalmic surgery on the cornea in order to correct vision defects. Techniques for ablative photodecomposition include, but are not limited to, LASIK, LASEK, and PRK. Conventional treatment by these techniques is typically indicated for refractive defects including myopia, hyperopia, and presbyopia, with or without astigmatism. In some cases, re-treatment from a previous surgery is also indicated.
Although surgeons administer the ophthalmic treatment, it is typically the laser manufacturers who program their lasers with tissue ablation algorithms to effect suitable treatment for the various diagnosed refractive defects. As used herein, the term “tissue ablation algorithm” refers to the process or procedure carried out in and by the hardware/software of the laser system. As illustrated schematically by the laser system
10
in
FIG. 1
, some type of diagnostic input
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from a surgeon and/or one or more diagnostic devices
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is sent to a laser platform
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. The laser platform includes a computer-linked control system
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that utilizes software to compute an appropriate laser ablation shot file based upon optical zone size and other input parameters entered by the surgeon. The laser platform also includes hardware in the form of beam shaping and steering optics that react to instructions from the control system to deliver the shot file in the appropriate manner to the cornea. Thus, the laser platform is a “smart” device, so to speak, because it is there that both information processing and treatment execution occur. In an aspect shown by the dotted lines, the laser platform is capable of receiving a computer-readable medium
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having both enablement and instructional software stored therein which can be processed by the computer system in the laser platform.
Certain disadvantages attach to the methodologies such as those described above. In the first case described, the laser platform is burdened with computer hardware and software adding to the complexity and cost of every unit. In the second scenario described above, the computer-readable medium may be in the form of a single use enablement card, for example, as described in U.S. Pat. Nos. 6,296,634 and 6,364,873. Such enablement cards are typically purchased by a user, and generate a set per-procedure fee for the laser manufacturer. Each treatment procedure requires a card, while the laser system continues to require the necessary computer hardware and software as mentioned above. Thus the laser system lacks flexibility and is no less burdened than described above. Moreover, there are many aspects of the laser platform that can malfunction, increasing the risk of surgical downtime for the user. Trained technicians having skills in multiple technical fields are required to maintain and service the multi-component laser platforms.
In view of the foregoing and other disadvantages currently associated with typical laser vision correction systems, the inventors have recognized a need for improvements that increase the flexibility and reduce the cost of making, supplying, maintaining, and controlling laser vision correction systems, and which make it easier for the surgeon to provide the best treatment outcomes for their patients.
SUMMARY OF THE INVENTION
The invention is generally directed to apparatus and methods involved in the control of a laser vision correction system, and a system incorporating these controls.
An embodiment of the invention is directed to a device-readable medium on or in which is stored a pre-programmed, readable, first corrective instruction reference. This instruction reference corresponds to an encoded customized corrective instruction. As used herein, the term “customized corrective instruction” refers to the number, sequence, and placement of laser pulses for a particular laser vision correction treatment. The instruction is determined by a calculation module located external to the medium and to the laser platform, and is executable by the laser platform of a laser vision correction system. The customized corrective instruction is determined in a manner that will be described in greater detail below. A particular customized corrective instruction is then encoded in such a manner that the instruction can be executed by the laser platform upon recognition of the corresponding instruction reference stored in or on the medium. In an aspect of this embodiment, the first corrective instruction reference stored in or on the medium is a necessary and sufficient component for enabling the laser platform to execute the customized instruction when the instruction reference is properly recognized. In an alternative aspect, the first instruction reference is a necessary but not sufficient component for allowing enablement and execution of the customized instruction by the laser platform. Rather, a second, readable corrective instruction reference is stored in or on the medium and in combination with the first corrective instruction reference, is sufficient for enabling execution of the customized instruction. Preferably, the second instruction reference will correspond to an encoded user ID or laser platform ID which will be associated with the customized instruction. In an alternative aspect, the medium may have stored therein a second pre-programmed instruction reference and a third pre-programmed instruction reference, corresponding to a user ID and a laser platform ID, in addition to the first instruction reference corresponding to the customized corrective instruction. In this aspect, all three matching instruction references are necessary and, in combination, sufficient components for enabling the execution of the customized instruction by the laser platform. With respect to all of the aspects referred to above, the total data storage requirement for any or all of the instruction references in combination, along with any other information stored in the medium, preferably will not exceed 1000 bytes of storage space. In another aspect according to this embodiment, the medium includes a laser platform disablement feature that limits a preset number of uses of the laser platform for each readable medium unit. This feature provides an annuity structure for laser system use as is well known in the art. In a further aspect, the medium includes a beam sizing and shaping feature to provide a desired beam diameter and beam energy profile for ablating a corneal surface and/or facilitating beam diagnostics.
In another embodiment according to the invention, a laser vision correction system includes a calculation module that can receive input data relating at least to a refractive defect of a patient's eye and calculate a customized corrective instruction based, at least in part, upon the input data. As used herein, the term calculation module refers either to a hardware device, computer-executable software which performs all pertinent aspects of an ablation treatment algorithm, or a combination of hardware, software, and/or firmware for determining the customized corrective instruction. The calculated customized corrective instruction is then encoded such that the encryption will allow a matching correspondence to a pre-programmed first corrective instruction reference that is stored in or on a device-readable medium. The system further includes a laser platform that can receive the readable medium and execute the customized corrective instruction, as a necessary condition, only when the first corrective instruction reference corresponding to the encoded customized corrective instruction is recognized by the laser platform. The calculation module is external to the laser platform and preferably resides in a diagnostic platform that is used to generate at least some of the input data. In a p
Hohla Kristian
Lang Stefan
Youssefi Gerhard
Shay David M.
TechnoVision GmbH
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