Surgery – Endoscope – Sterilizable
Reexamination Certificate
2000-03-27
2002-12-10
Leubecker, John P. (Department: 3739)
Surgery
Endoscope
Sterilizable
C073S045500, C073S865900, C128S898000
Reexamination Certificate
active
06491625
ABSTRACT:
FIELD OF THE INVENTION
The invention relates generally to the field of endoscopes and more specifically to an apparatus and method for testing the water resistant caps used in the reprocessing of endoscopes and other medical video equipment that require such water resistant caps.
BACKGROUND OF THE INVENTION
Video cameras and endoscopes are used in a variety of surgical procedures. An endoscope provides the operator with internal electro-visual inspection of a particular area of interest within a patient. Endoscopes are generally equipped with accessories that allow the operator to collect biopsy or tissue samples or repair damage through electrosurgery.
One common configuration of an endoscope includes a connector component and a control component. The control component generally includes the various operator controls for the instrument, for example, controls for the light and video components as well as the biopsy forceps. The connector component includes connections for inter alia the light source, the air and water inlets, the suction source, as well as the electrical connections for the videoscope cable. Although the particular endoscope described above is used as an example, the present invention relates to any applicable surgical video device.
Cleaning, disinfecting, and sterilization (hereinafter collectively referred to as “reprocessing”) of endoscopes allows for repeated uses. The electrical connector for the video cable is not waterproof and must be covered with a water-resistant cap before washing or immersion of the endoscope. Otherwise the endoscope will be damaged requiring costly repair or replacement. The water resistant cap is attached to the electrical connector on the endoscope to protect the connector from water penetration during reprocessing. The water resistant cap resists fluid from entering the endoscope (or other applicable medical instrument) or contacting the electrical connections thereof during reprocessing.
Prior to reprocessing, endoscopes are leak tested to detect leaks before any fluid invasion occurs, thereby reducing repair costs. For leakage testing, the water resistant cap is configured for connection to a leakage tester. As a non-limiting example, the cap may be configured with a venting connector. The leakage tester supplies pressurized air to the endoscope via the water resistant cap. Thus, the endoscope (with the water resistant cap correctly attached) is submerged in water with a positive air pressure applied. The endoscope is flagged as defective if air bubbles emanate from the endoscope. Unfortunately, however, this test does not account for each component of the endoscope. Notably, the foregoing test does not test for leaks in the water resistant cap, itself A defective water resistant cap can cause great damage to an otherwise acceptable endoscope as a result of the reprocessing process. This damage results from leakage from the defective cap into the electrical and video connectors.
The above-described test provides positive air pressure. Thus, the configuration of the connection between the leakage tester and the water resistant cap requires a sealed environment. Any seals within the cap that are not waterproof are not detectable. For example, the water resistant cap may have an inner O-ring seal that is not affected by the above-described leakage test.
Currently, the water resistant cap is inspected through visual inspection only. The inside of the cap is checked for dryness and an inspector inspects the seal inside the cap for visible scratches, flaws or debris. There is a need, therefore, for an effective apparatus and method for testing the water resistant cap of an endoscope apparatus, including both the frame of the cap as well as the interior seals. As discussed above, the ability to detect leaks will prevent costly damage to the electrical connections of the endoscopy equipment.
SUMMARY OF THE INVENTION
The present invention is a cap tester for a water resistant cap that addresses the aforementioned deficiencies in current testing procedures.
The present invention is a cap tester for a water resistant cap for medical video equipment that comprises a neck capable of insertion within the cap. The neck has an air duct extending therethrough. Preferably, the neck further comprises at least one projection extending outwardly from the neck. The projection mates with interior grooves of the cap to releasably connect the cap tester to the cap. A collar extends outwardly beyond the neck to provide a cover to the neck upon insertion into the cap. A conduit extends above the collar and substantially aligns with the duct within the neck that may be connected to a positive air supply. Thus, upon placing a cap tester within the cap, the method of the present invention comprises pressurizing the cap and cap tester, submersing the cap and cap tester in liquid and observing the immersed cap and cap tester for air bubbles thereby indicating a leak in either the cap frame or any seal located therein.
The present invention also comprises a method for testing a cap comprising placing a cap tester within the cap, pressurizing the cap and cap tester, submersing the cap and cap tester in liquid and observing the immersed cap and cap tester for air bubbles thereby indicating a leak.
A further embodiment of the present invention comprises a cap tester for a water resistant cap, the cap having a cavity for medical video equipment. The cap tester comprises a housing, a first aperture and a second aperture in the housing, such that the housing sealably connects to the water resistant cap. The first and second apertures are fluidly connected to allow for the application of a positive pressure through the first and second apertures. Further, the second aperture is open to the cap to form a positive pressure within the cavity of the cap for leak detection purposes.
These and other aspects of the present invention as disclosed herein will become apparent to those skilled in the art after a reading of the following description of the preferred embodiments when considered with the drawings. The drawings are for the purpose of describing a preferred embodiment of the invention and are not intended to limit the present invention.
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patent: 5868667 (1999-02-01), Lin et al.
Evis Gastrointestinal Videoscope/Colonovideoscope/ Sigmoidovideoscope Instructions Manual, Olympus Corporation, believed to be prior art.
Evis Colonovideoscope Instructions Manual, Olympus Corporation, believed to be prior art.
Jensen Bradly Lawrence
Newton William Charles Brian
Leubecker John P.
Ram Jocelyn
The Scope Exchange, Inc.
Womble Carlyle Sandridge & Rice PLLC
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