Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
2002-01-24
2004-10-19
Jaworski, Francis J. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
Reexamination Certificate
active
06805669
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to a method and diagnostic ultrasound accessory for marking a patient's skin during an ultrasound examination.
BACKGROUND OF THE INVENTION
Never before has the diagnostic ultrasound examination been such an integral part of a physician's arsenal. With the expanding technology of medical imaging modalities and medical interventions, the global trend is towards less invasive medical procedures. Therefore, even more emphasis and value have been placed on the precision of pre-interventional diagnostic imaging modalities, including ultrasound.
Historically, a common application of ultrasound has been an ultrasound evaluation of a patient's greater saphenous vein prior to its use as a conduit for arterial surgical reconstruction for lower extremity revascularization in order to salvage a patient's ischemic leg. The ultrasound evaluation is done to save operation time, so the surgeon can avoid making an unnecessarily long incision down the entire length of the patient's leg, which often has non-healing wounds or gangrene present, and so the surgeon can avoid making an incision in the patient's leg only to discover that the desired vein is in a different location, is absent, is duplicated, or is not suitable for use. To determine whether a vein will be suitable, its patency, transverse diameter, quality and location are evaluated by an ultrasound technologist. If the vein is adequate, its course is marked on the patient's skin with a permanent marking pen.
The following procedure is one currently used to preform the ultrasound evaluation and marking of a patient's greater saphenous vein. A diagnostic ultrasound machine, ordinarily with a 7-10 MHZ linear array transducer, is used. The ultrasound technologist visually estimates the center of the face of the transducer and denotes it with a permanent marking pen line directly on the transducer housing. Another technique is to apply a transducer cover to protect the transducer housing and to mark the cover. The medial aspect of the patient's leg is prepped with alcohol to remove gel residues, lotions or oils. Ultrasound gel is applied, and the leg is scanned to track and mark the vein site, generally at two centimeter increments. The technologist visually centers the vein in the middle of the ultrasound screen, which should appear to correspond with the center of the transducer. The technologist slightly tilts the transducer and wipes the gel from the patient's skin beneath the transducer, with a cloth, while maintaining the transducer contact and, hence, position on the skin. The patient is asked to remove the cap from a permanent marking pen and to place it in the technologist's hand. The technologist marks a dot at the approximate site on the skin based on his/her visual estimation of the center of the transducer. The lights in the room are usually turned off throughout the ultrasound examination. Time is allowed for the ink to dry. Ultrasound gel is reapplied, and the area is re-scanned to confirm that the mark corresponds with the target vessel. Frequently, an error in marking is made, and an alcohol swab is used to erase the mark and the marking process is repeated. This tedious and cumbersome procedure is repeated over the entire length of at least one of the patient's legs. Often it is necessary to assess all four of the patient's extremities to find enough vein for a long composite vein bypass graft. Upon completion of the evaluation and marking, the room is re-lit, gel residue is removed, and the dot marks are lightly swabbed with alcohol to remove any residual gel. Generally, a new marker is now used to re-mark the skin and connect the dots. The patient is instructed not to wash off the marks, and the patient may need to re-mark them at home if the surgery is not scheduled for a few days. If a second technologist is available, one technologist will operate the ultrasound transducer and ultrasound machine controls, while the other technologist wipes away the gel and marks the skin.
Obviously, this method of marking the skin is inherently inaccurate, laborious, and unsophisticated for ultrasound technologists, physicians and other ultrasound operators. Numerous other ultrasound-guided skin-marking procedures are also in use, and all of them are equally deficient as the one just described. While ultrasound methods for identifying targets prior to physician intervention are becoming more valuable, with numerous applications, accuracy is lost because of the crude and cumbersome techniques employed for marking the skin above a feature of interest.
SUMMARY OF THE INVENTION
Accordingly, one of the objects of the present invention is to increase the accuracy and efficiency of ultrasound-guided skin-marking procedures.
Another object of the present invention is to enable an ultrasound operator to more easily produce a more accurate mark on a patient's skin above a feature of interest.
Yet another object of the present invention is to enable an ultrasound operator to produce a mark on a patient's skin above a feature of interest in a more technologically precise and sophisticated manner.
It is a further object of the present invention to provide a method for marking skin above a feature of interest during an ultrasound evaluation which is more accurate and efficient than current procedures.
It is another object of the present invention to provide a preferably disposable diagnostic ultrasound accessory for marking skin above a feature of interest that makes ultrasound-guided skin-marking procedures more accurate and efficient than current procedures.
It is a further object of the present invention to provide a preferably disposable diagnostic ultrasound accessory for marking skin above a feature of interest that is easily operated during use.
It is a particular object of this invention to provide a simple, yet highly accurate, easily-manipulated, preferably disposable diagnostic ultrasound accessory which an ultrasound technologist or operator can readily attach to an ultrasound transducer.
It is also a particular object of this invention to provide a simple, yet highly accurate, easily-manipulated, preferably disposable diagnostic ultrasound accessory, the overall geometry of which is designed for optimal ergonomics, accuracy and efficiency.
To attain the above-mentioned objects, the invention provides a method and device for marking a patient's skin during an ultrasound examination to denote a feature of interest. In one embodiment, the device comprises a first portion (or element) and a second portion. The first portion is adapted for attachment of the device to an ultrasound transducer. The second portion is adapted for marking the skin of the patient to denote the feature of interest. The first and second portions are rotatably attached to each other. During an ultrasound examination of the patient to locate the feature of interest, the second portion is moved, preferably rotated, so that it is spaced away from the patient's skin. The ultrasound examination is conducted in the normal manner until the feature of interest is located, at which time the second portion is moved, preferably rotated, so that it contacts and marks the patient's skin to denote the feature of interest. The gel need not be removed from the patient's skin to mark it, and the examination can be immediately resumed once the feature of interest is marked on the patient's skin and the second portion is moved, (e.g., rotated) again so that it is spaced away from the patient's skin. These procedures can be repeated as many times as needed to identify and mark all features of interest or to map a feature of interest (e.g., a vein). The entire ultrasound examination and accurate marking of all features of interest on the patient's skin can be performed by a single person in substantially less time than is required by current procedures.
Therefore, one embodiment of the present invention is directed to an ultrasound ac
Jaworski Francis J.
Sheridan & Ross P.C.
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