Surgery – Miscellaneous
Reexamination Certificate
2000-03-15
2002-07-02
Winakur, Eric F. (Department: 3736)
Surgery
Miscellaneous
C128S898000
Reexamination Certificate
active
06412491
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to the field of medicine and more particularly to a device and method for conducting a breast examination.
BACKGROUND OF THE INVENTION
Tactile physical examination of the breast is an important screen for breast cancer. Both physician examination and self examination are widely practiced. The palpation or detection of “lumps” in the breast is the principle objective of a breast examination.
Early detection of “lumps” is very desirable but difficult due to the relatively small size of lumps and their location within a mass of otherwise healthy tissue. As a consequence, and in many instances, a single lump will be evaluated by several people to confirm detection.
The classic tactile examination involves sliding fingers over the skin to detect lumps. The friction may cause patient discomfort and the friction always reduces the sensitivity of the fingers. Consequently the examiner is frequently required to pause and examine the small portion of the tissue beneath their fingers, lift their fingers from the tissue, reapply them to an adjacent portion of the tissue, and repeat the palpation maneuver. This extended series of motions is continued until the entire area of concern has been examined. One disadvantage with this intermittent method of examination is that lumps may be missed or passed over during the examination due to the repeated lifting and repositioning of the examiner's hands.
Another problem with direct contact is the tendency for the tissue under examination to be move when pressure of the examiner's hand is applied to the tissue. This is particularly problematic for thick and soft tissues. The movement of tissue has at least two undesirable effects. First, portions of the tissue may escape tactile examination. Second, after a potentially pathological feature, such as a lump, is detected by tactile examination, the location of such feature is difficult to describe with accuracy. Consequently, subsequent search for the feature is difficult.
Another significant drawback with tactile examinations involves the embarrassment that some patients experience when a physician conducts such extensive exams. Embarrassment or modesty can reduce the frequency of such examinations reducing the early detection of cancer. These embarrassment and modesty issues may also complicate or hinder the actual examination, thereby undercutting the effectiveness of such procedures.
Various examination garments have been created to address these problems. For example, U.S. Pat. Reissue No. 34,353 discloses a pad which includes a sealed enclosure made of an elastic material such as latex rubber. The pad contains a liquid lubricant inside the enclosure. During a tactile examination, the top wall of the enclosure moves with the hand of the examiner while the bottom wall remains stationary relative to the object being examined. Other patented arrangements have addressed the issues of associated with tactile examination. U.S. Pat. No. 3,154,789 discloses a disposable examination garment comprising a vest-type article having individual flaps for selectively revealing one breast at a time for examination. U.S. Pat. No. 4,873,982 discloses yet another examination garment for conducting tactile breast examinations. The garment comprises a “tube-top” type article having a form-fitting elastic inner ply and a loose-fitting elastic outer ply. The garment covers the breasts during the tactile examination, thereby aiding modesty. The elastic inner and outer plies are designed to have a reduced coefficient of friction to allow the examiner's fingers to slide more readily while traversing the breast. A significant drawback exists, however, in that the fabric is thick and thus diminishes the tactile sensitivity of the examiner.
The present invention is directed at overcoming the problems set forth above.
SUMMARY OF THE INVENTION
The present invention is an examination device which can be used to facilitate physical examination of the breast. The invention is disclosed in the context of a breast examination but may be used in other applications as well. The device includes a drape which can be applied to the body. It has a smooth “reduced friction” surface on one side and a complimentary surface that clings to exposed skin. Fiducial markers on the device are provided to orient the device on the body. The device accepts indicia or markers that can be used to identify and to relocate “suspected” lumps.
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patent: 4737109 (1988-04-01), Abramson
patent: 4867686 (1989-09-01), Goldstein
patent: 4873982 (1989-10-01), Morrison
patent: 5894844 (1999-04-01), Rohrberg
patent: 5916180 (1999-06-01), Cundari et al.
patent: 6091981 (2000-07-01), Cundari et al.
Beck & Tysver P.L.L.C.
Veniaminov Nikita R.
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