Registers – Systems controlled by data bearing records – Inventory
Reexamination Certificate
2002-10-16
2003-11-18
Lee, Diane I. (Department: 2876)
Registers
Systems controlled by data bearing records
Inventory
Reexamination Certificate
active
06648223
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates generally to the field of cataract surgery and more particularly to surgical systems used during the phacoemulsification technique of cataract removal.
The human eye in its simplest terms functions to provide vision by transmitting light through a clear outer portion called the cornea, and focusing the image by way of the lens onto the retina. The quality of the focused image depends on many factors including the size and shape of the eye, and the transparency of the cornea and lens.
When age or disease causes the lens to become less transparent, vision deteriorates because of the diminished light which can be transmitted to the retina. This deficiency in the lens of the eye is medically known as a cataract. An accepted treatment for this condition is surgical removal of the lens and replacement of the lens function by an artificial intraocular lens (IOL).
In the United States, while other lens removal modalities are being introduced, the majority of cataractous lenses are still removed by a surgical technique called ultrasound phacoemulsification. During this procedure, a thin phacoemulsification cutting tip is inserted into the diseased lens and vibrated ultrasonically. The vibrating cutting tip liquifies or emulsifies the lens so that the lens may be aspirated out of the eye. The diseased lens, once removed, is replaced by an artificial lens.
A typical ultrasonic surgical device suitable for ophthalmic procedures consists of an ultrasonically driven handpiece, an attached cutting tip, and irrigating sleeve and an electronic control console. The handpiece assembly is attached to the control console by an electric cable and flexible tubings. Through the electric cable, the console varies the power level transmitted by the handpiece to the attached cutting tip and the flexible tubings supply irrigation fluid to and draw aspiration fluid from the eye through the handpiece assembly. The disposable portions of the system, such as the cutting tips, fluid tubings, cassette, drapes and sleeves, are generally sold together as a complete unit in the form of a surgical pak.
In use, the ends of the cutting tip and irrigating sleeve are inserted into a small incision of predetermined width in the cornea, sclera, or other location. The cutting tip is ultrasonically vibrated along its longitudinal axis within the irrigating sleeve by the crystal-driven ultrasonic horn, thereby emulsifying the selected tissue in situ. The hollow bore of the cutting tip communicates with the bore in the horn that in turn communicates with the aspiration line from the handpiece to the console. A reduced pressure or vacuum source in the console draws or aspirates the emulsified tissue from the eye through the open end of the cutting tip, the cutting tip and horn bores and the aspiration line and into a collection device. The aspiration of emulsified tissue is aided by a saline flushing solution or irrigant that is injected into the surgical site through the small annular gap between the inside surface of the irrigating sleeve and the cutting tip.
With the advances that have been made in the last few years in digital circuitry, manufacturers are able to design and built surgical instruments that can automatically change the operating parameters to suit special techniques or situations. Operating parameters such as aspiration fluid flow rate and vacuum, irrigation fluid flow rate and pressure and handpiece power and duty cycle can all be preprogrammed for a specific surgeon or surgical procedure. In addition, the various cutting tips, sleeves, tubings and cassettes can be customized to suit the techniques being used by the surgeon. In order optimize the system, it is important that the operating parameters, tips, sleeves , tubings and cassettes all be designed to work together. With the various disposable products that are available today, it is often difficult for the surgeon to know if the operating parameters of the surgical console have been optimized for the contents of the surgical pak being used.
One prior art device illustrated in U.S. Pat. Nos. 5,899,674 and 6,059,544 (Jung, et al.) discloses a surgical cassette having an identification system that can be used by the surgical console to identify the type of cassette being used. Another similar device, illustrated in U.S. Pat. No. 6,036,458 (Cole, et al.), discloses a surgical cassette having an identification system that can be used by the surgical console to identify the type of cassette being used as well as how many times the cassette has been used. None of these references discloses a system wherein the surgical console can identify all of items contained in the surgical pak, and automatically adjust the operating parameters of the system for those contents.
Therefore, a need continues to exist for a system that can identify all of the contents of a surgical pak and automatically adjust the operating parameters of the system for those contents.
BRIEF SUMMARY OF THE INVENTION
The present invention improves upon the prior art by providing a surgical system console having an electronic identification system, such as a bar code scanner, magnetic reader or other sensing means (e.g., optical, magnetic or other system) system that works in conjunction with a unique identifier on the surgical pak so as to identify the contents of the pak to the surgical console control (e.g., CPU). That information can be used for a variety of further activities, such as inventory management, product usage, traceability, OR support, patient billing, collection of statistical data, automatic setting of the surgical operating parameters by the surgical console, servicing and to print out the contents of the surgical pak on a list or any other recordable media (e.g., DVD, CD-ROM, floppy disk, hard drive, ZIP drive).
Accordingly, one objective of the present invention is to provide a surgical system having a console with an electronic identification system.
Another objective of the present invention is to provide a surgical system having a console capable of identifying the contents of the surgical paks used throughout the procedure.
Another objective of the present invention is to provide a surgical system having a surgical pak having contents that are identifiable to the surgical console.
Still another objective of the present invention is to provide a surgical system wherein information from the contents of the surgical paks is identified to the surgical console, and the console uses this information for setting automatically the operating parameters to be used by the surgical console.
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Boukhny Mikhail
Dacquay Bruno
Fanney Douglas M.
Southard Michael A.
Thoe David
Alcon Inc.
Lee Diane I.
Schira Jeffrey S.
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