Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
1999-11-24
2003-06-03
Shaw, Shawna J. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S437000, C128S915000, C128S916000
Reexamination Certificate
active
06574499
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to mammography methods and to apparatus for carrying out such methods.
BACKGROUND OF THE INVENTION
Currently, on an international scale, ultrasound breast examination is an accepted medical modality applied both as a primary method for evaluation of the breasts of young patients, that is, those under 40 years of age, and as an adjunct to x-ray mammography. See, for example, Kasumi, F., et cl., “Topics in Breast Ultrasound,” Seventh International Congress on the Ultrasonic Examination of the Breast, Shinohara Publications, Inc., 1-7, Hongo 2-chome, Bunkyo-ku, Tokyo 113, Japan, 1991; Tohno E., et al.,
Ultrasound Diagnosis of Breast Diseases
, New York, Churchill-Livingstone, 1994; and Stavros, A. T. et al., “Solid Breast Nodules: Use of Sonography to Distinguish Between Benign and Malignant Lesions,” Radiology 196, pp. 123-134, 1995. In terms of the diagnostic effectiveness of the ultrasound breast imaging, a number of investigators from the early 1980s to the present have shown that this modality is not limited to diagnosing the solid or cystic nature of a breast mass. It is capable, with a high degrees of accuracy, of providing imaging data which permits differentiation of benign and malignant breast masses. See, for example, Stavros, A. T., et al., “Solid Breast Nodules: Use of Sonography to Distinguish Between Benign and Malignant Lesions,” Radiology 196, pp. 123-134, 1995; Kelly-Fry, El, et al., “Factors Critical to Highly Accurate Diagnosis of Malignant Breast Pathologies by Ultrasound Imaging,” Ultrasound 82 eds., Lerski, R. A. et al., Pergamon Press, Oxford and New York, 1983; Harper, P., et al., “Breast Ultrasound: Report of a 5-Year Combined Clinical and Research Program,” Le Journal Francais d'Echograplaie, 2n 5, pp. 133-139, 1984; Ueno, E., et al., “Classification and Diagnostic Criteria in Breast Echography,” Japan Journal of Medicine, Ultrasonics, vol. 13, no. 1, pp. 19-31, 1986 (in English); Ueno E., et al., “Dynamic Tests in Real-Time Breast Echography,” Ultrasound in Med. & Biology, 14 (supp. 1), pp. 53-57, 1988, Tohnosu, N., et al., “Clinical Evaluation of Ultrasound in Breast Cancers in Compression with Mammography, Computed Tonography and Digital Subtraction Angiography,” Topics in Breast Ultrasound, eds., Kasume, F., et al., Shinohara Pub. Inc., Tokyo, Japan, 1991; and Gerlach, B., et al., “Comparison of X-ray Mammography and Sonomammography of 1,209 Histological Verified Breast Diseases,” Breast Ultrasound Update, eds., Madjar, H., et al., Karger, Bascl, Freiburg, New York, 1994. In Japan, ultrasound breast imaging has equal diagnostic status with x-ray mammography. See, for example, Ueno, E., et al., “Dynamic Tests in Real-Time Breast Echography,” Ultrasound in Med. & Biology, 14 (supp. 1), pp. 53-57, 1988; Tohnosu, N., et al., “Clinical Evaluation of Ultrasound in Breast Cancers in Compression with Mammography, Computed Tomography and Digital Subtractions Angiography,” Topics in Breast Ultrasound, eds., Kasumi, F., et al., Shinohara Pub. Inc., Tokyo, Japan, 1991. European investigators have found that ultrasound breast imaging can equal the accuracy of x-ray mammography in the diagnosis of overt, malignant breast masses. See, for example, Gerlach, B., et al., “Comparison of X-ray Mammography and Sonomammography of 1,209 Histological Verified Breast Diseases,” Breast Ultrasound Update, eds., Madjar, H., et al., Karger, Basel, Freiburg, New York, 1994; Dambrosio, F., et al., “Clinical Program of Breast Surveillance by Means of Echopalpation; Results from January 1985 to May 1992,” Breast Ultrasound Update, eds., Madjar, H. et al., Karger, Basel, Freiburg, New York, 1994; and, Leucht, W., et al., “Is Breast Sonography an Additional Method for the Diagnosis of Palpable Masses,” Topics in Breast Ultrasound, eds., Kasumi, F., et al., Shinohara Pub. Inc., 11-7 Hongo 2-chome, Bunkyo-ku, Tokyo 113, Japan, 1991. In the United States, many clinicians during the 1980s and early 1990s restricted ultrasound breast imaging to a limited role of differentiation between cystic and solid masses. See, for example, Sickles, E. A., “Imaging Techniques Other Than Mammography for the Detection and Diagnosis of Breast Cancer,” Recent Results in Cancer Research, 119, pp. 127-135, 1990; Jackson, V. P., “The Role of US in Breast Imaging,” Radiology, 117, pp. 305-311, 1990; Bassett, L. W. et al., “Breast Sonography,” American Journal of Radiology, 156 (3), pp. 449-455, 1991; Feig, S. A., “Breast Masses: Mammographic and Sonographic Evaluation,” Radiol. Clin. North Am., 30, pp. 67-93, 1992; and Orel, S. G., et al., “Nonmammographic Imaging of the Breast: Current Issues and Future Prospects,” Sem. In Roentgenology, XXVIII, no. 3, pp. 231-241, 1993. Following the 1995 publication of a clinical study which provided further data on the successful differentiation of benign and malignant masses by ultrasound breast imaging techniques, this modality was more widely applied in the United States. See, for example, Stavros, A. T. et al., “Solid Breast Nodules: Use of Sonography to Distinguish Between Benign and Malignant Lesions,” Radiology 196, pp. 123-134, 1995.
Since the 1980s, most ultrasound breast examinations have been carried out with the patient in the supine position. Imaging is carried out by moving a hand-held ultrasound transducer across the free flowing surface of the breast and recording the images on film. By contrast, for x-ray mammography, the patient is in a standing or sitting position with the breast compressed between a plastic paddle and the surface of an x-ray film holder module. The breast is alternately compressed in various orientations such as cranio-caudal, lateral and oblique while the x-ray beam traverses the breast in each of these positions. For each individual position, an image is recorded. Currently, to correlate precisely standard breast ultrasound imaging data with that provided by x-ray mammography data can sometimes be impossible because the anatomical orientations of tissues traversed by the x-ray beam for the various compressed breast positions are different from the anatomical position of tissues traversed by the ultrasound beam following its entrance into an uncompressed breast in a supine position. Also, since tissue is mobile, the location of a breast mass as imaged when a breast is compressed between two plates can be different from that of its imaged location when the breast is uncompressed and in a supine position. These problems can lead to diagnostic errors.
In an attempt to improve correlation between ultrasound and x-ray imaging data, in 1983 Novak demonstrated a technique for holding the breast in the same positions used in x-ray mammography while applying a linear array ultrasound transducer in direct contact with the breast surface. See, Novak, D., “Indications for and Comparative Diagnostic Value of Combined Ultrasound and X-ray Mammography,” European Journal of Radiology, 3, 1983. A plexiglas plate was used as a support on one side of the breast while the ultrasound transducer contacted the skin surface of the opposite side. The breast was not compressed between two plates.
In the early 1990s, Kelly-Fry, et al, demonstrated that specially designed breast compression paddles, constructed from various types and thicknesses of plastics, including polyesters, polycarbonates and acrylics, can transfer both x-ray and ultrasound, without serious attenuation of either modality. See, for example: Kelly-Fry, E., et al, “A New Ultrasound Mammography Technique That Provides Improved Correlation With X-ray Mammography,” Amer. Col. Radiol., 24
th
National Conference on Breast Cancer, New Orleans, La., March 1990, Kelly-Fry, E., et al, “Adaptation, Development and Expansion of X-ray Mammography Techniques for Ultrasound Mammography,” Journal of Ultrasound in Medicine, 10, no. 3, S 16, supplement, March 1991; Kelly-Fry, E., “New Techniques for Ultrasound Mammography,” National Cancer Institute Breast Imaging Workshop, Bethesda, Md., Sep. 4-6, 1991; and, Kelly-Fry, E., et al, “Rapid Ultrasound Scannin
Dines Kris A.
Kelly-Fry Elizabeth
Romilly Ada Patricia
Gridley, Esq. Doreen J.
Miller Ice
Shaw Shawna J.
St. Peter, Esq. Rachel L.
Xdata Corporation
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