Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
2000-10-13
2003-02-25
Lateef, Marvin M. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S438000
Reexamination Certificate
active
06524246
ABSTRACT:
FIELD OF THE INVENTION
The field of the present invention is ultrasonic scanning and diagnostics for cellular tissue.
BACKGROUND OF THE INVENTION
Ultrasonic probes have been used for scanning cellular tissue for many years. Presently, any medical ultrasound examination, whether of the heart, pelvis, abdomen, soft tissues or any other system, is usually displayed as a number of individual frames or pictures from a study performed in a dynamic movie-like manner. The usefulness of the scan, however, is dependent on the skill of the operator, who manipulates the probe by hand while watching the scan images on a monitor to identify areas of interest. Once these areas are identified, the operator usually records single or multiple single scan images showing those areas.
Because the operator must choose a few frames from the large number generated during the scan, the process is open to error. The operator may fail to select an image of an important finding, or may select an image that misrepresents the overall findings. In addition, since the operator is manipulating the probe by hand, and the speed of the probe over the tissue cannot be correlated with the image capture rate of the probe, the coverage of the scanned tissue is somewhat haphazard. As a result, the operator does not record a series of images that represent a contiguous and complete set of images for the entire scanned tissue. Nor does the manual operation of the probe allow for entirely uniform coverage of the tissue, even if multiple passes are used.
A second method of recording ultrasonic examinations is used for dynamic examinations such as echocardiography, where a dynamic recording is made on videotape. Unfortunately, this analog method is not matched to the digital sonographic recording of individual frames. Consequently, there is a great loss of detail that prevents the evaluation of individual frames, which limits the usefulness of the videotape for diagnosing tissue anomalies. In addition, the use of separate videotapes for individual patients is expensive, and creates a storage problem because of the bulkiness of the tapes. The interpreting physician has no way to vary the speed of playback or to vary the size of the images. Nor can the physician vary the inherent contrast and brightness of the images, only the monitor settings. These difficulties lengthen the review time and prevent optimum viewing.
Specific to screening asymptomatic women for occult breast cancer, there are two methods presently in widespread use, physical examination and mammography. Both of these methods are imperfect. Physical examination, whether performed by the woman herself or by a physician or other health care provider, usually cannot detect cancers smaller than ½ inch in diameter. Some cancers have to be many times larger to be detected. Mammography is unable to detect as many as 30 percent of cancers smaller than ½ inch. About 5 to 10 percent of larger cancers are mammographically occult. Mammograms also use radiation and necessitate painful compression of the breasts, which discourage women from having routine mammograms.
Although not well recognized by the medical community, ultrasound is very proficient at diagnosing breast cancers if the location of the abnormality is first discovered by another modality, such as mammography or physical examination. When using ultrasound as a screening method for the entire breast, however, malignancies are usually difficult to pick out of the background tissue. In the past there have been two schemes to use ultrasound for breast screening, but they failed to gain acceptance due to their unacceptably low success rate in finding cancers.
One method was a water bath system with multiple ultrasound probes and the breast in a water bath that allowed generation of images of the whole breast in consecutive slices. These slices could be viewed in sequence at a rate of one every ten seconds.
The second method was to videotape-record the scanning performed by a technician examining the entire breast. This method had the disadvantage of being somewhat haphazard in breast coverage. The variable speed of manual motion does not allow the tissue to be uniformly imaged because the speed is not synchronized to the frame capture rate of the ultrasound probe. Videotaping also results in a degradation of the images for the reasons described above.
To date, nomethod has been developed to uniformly and reliably use ultrasound probes to create a contiguous and complete set of scan images for an entire area of cellular tissue, such as a human breast. Ultrasound is usually used to investigate areas of interest in cellular tissue that have already been identified by other screening methods such as mammograms, x-rays, and MRI-scans. Ultrasound is not ordinarily used as a screening tool for cellular tissue anomalies.
SUMMARY OF THE INVENTION
The present invention is directed to an improved system of ultrasonic scanning and diagnostics of cellular tissue. A sequence of cross-sectional ultrasonic images of tissue are generated, with means to determine the location of each individual image. The present invention also presents a systematic method for screening cellular tissue, using cross-sectional ultrasonic scans.
In a first separate aspect of the present invention, an ultrasonic probe is propelled over the tissue to be scanned at a uniform speed. Uniform imaging of the tissue can be achieved.
In a second separate aspect of the present invention, an ultrasonic probe is propelled over the tissue to be scanned at a uniform speed. The speed of the probe over the tissue is matched to the image capture rate of the ultrasound scanner. Further uniform imaging of the tissue can be achieved.
In a third separate aspect of the present invention, an ultrasonic probe is propelled over the tissue to be scanned at a uniform speed. The angle of the ultrasonic probe may be adjusted prior to and during the scanning process to maintain optimal contact with the tissue being scanned. Further uniform imaging of the tissue can be achieved.
In a fourth separate aspect of the present invention, an ultrasonic probe is propelled over the tissue to be scanned at a uniform speed. The image data from the ultrasonic probe is converted and stored in a format compatible with a viewer. The scan data are viewed in a specialized viewer that allows rapid, sequential playback of the scan images. An improved method of scanning tissue for cancers and anomalies is thus achieved. The viewer can have the capability of allowing the user to select points of interest on individual scan images, and also select a known reference point on the same or another individual image. The viewer then calculates the distances between the two points in three dimensions. The exact location of the point of interest on the patient may thus be determined.
In a fifth separate aspect of the present invention, location and orientation data are collected for each image frame. This allows an ultrasonic probe to be operated without need for completely uniform speed, and still allow for accurate location of features or anomalies.
In a sixth separate aspect of the present invention, an ultrasonic probe is propelled over human breast tissue to be scanned in a uniform manner at a speed that is matched to the image capture rate of the ultrasound scanner. Uniform imaging of the breast tissue can be achieved.
In an seventh separate aspect of the present invention, an ultrasonic probe is propelled over human breast tissue to be scanned in a uniform manner at a speed that is matched to the image capture rate of the ultrasound scanner. The angle of the ultrasonic probe may be adjusted prior to or during a breast scanning process to maintain optimal contact with the breast tissue being scanned and still allow for accurate location of features or anomalies. Further uniform imaging of the breast tissue can be achieved.
In an eighth separate aspect of the present invention, the images can be viewed to allow the user to select points of interest on individual scan images, and also select
Goss Donald C.
Kelly Kevin M.
Peterson Richard J.
Ponce Luis E.
Royce Roger
Fulbright & Jaworski L.L.P.
Imam Ali M.
Lateef Marvin M.
Sonocine, Inc.
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