Device and method for examining female breasts using ultrasound

Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation

Reexamination Certificate

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Reexamination Certificate

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06409668

ABSTRACT:

The invention relates to an apparatus for examining female breasts with at least one ultrasonic transducer for scanning level layer areas in a stationary scanning position, with which ultrasonic beams can be coupled into at least one breast over a coupling medium, and to a transporting unit for displacing the or each ultrasonic transducer between scanning positions by a pre-determined path length.
The invention furthermore relates to a method for reducing artifacts of an ultrasonic image at least of a female breast, for which an ultrasonic transducer, for scanning level layer areas in a stationary scanning position, is shifted over at least the one breast by a transporting unit by a fixed path length between scanning positions and by consecutively shifting and a three-dimensional ultrasonic image is recorded and stored in an assigned memory unit by consecutively shifting and assigning a data value, corresponding to the shifting, to a layer image of an image sequence.
Such an apparatus and such a method are already known from the article “Acquisition and Stereoscopic Visualization of Three-Dimensional Ultrasonic Breast Data” by A. Hernandez, O. Basset, I. Dautraix et al., published in the journal IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control, volume 43, Jul. 1996, pages 576 to 580. The article discloses an apparatus with an ultrasonic transducer, which is set up to record two-dimensional layer images and can be shifted by means of a transporting unit by a specified path length between scanning positions, in which the scanning of the two-dimensional image takes place. The disclosed apparatus furthermore comprises a memory unit for storing the layer images recorded by the ultrasonic transducer, a data value, corresponding to the shifting, being assigned. By means of this assigning, a three-dimensional ultrasonic image is produced by the disclosed recording method and stored in the memory unit. For the stereoscopic representation of the three-dimensional ultrasonic image recorded, two different three-dimensional views of the object examined are calculated starting out from a single data set stored in the memory unit and in each case assigned to one eye of the viewer, in order to make possible a three-dimensional visual perception of the ultrasonic image to this viewer.
However, the occurrence of artifacts, which cannot be differentiated in the recorded images from the real, reflecting structures of the object examined, is a disadvantage. In particular, when direction-dependent effects in the form of tail-like image patterns occur, there is a need to check the photograph for genuineness, since direction-dependent effects may be indications of pathological changes in the tissue investigated. Furthermore, the tail regions of the direction-dependent image patterns remain hidden to a viewer, since they lie, for example, behind strongly reflecting structures in the sound beam direction and do not generate any visible reflections.
In the DE 35 03 477 A1, an ultrasonic diagnosis device is disclosed, which comprises a rod-shaped linear scanner with piezoelectric elements disclosed next to one another. The linear scanner can be shifted in its transverse direction by a specified path length by means of a transporting unit. By means of the consecutive shifting of the linear scanner between scanning positions and the subsequent synchronized reading of its piezoelectric elements, sectional images in the longitudinal direction of the linear scanner, as well as sections at right angles to this of a breast, which is to be examined, can be represented on a screen unit. Here also, the frequently occurring artifacts make a medical evaluation of the ultrasonic images difficult. Furthermore, regions, lying behind strongly reflecting or reinforcing particles in the direction of the sound ray, remain hidden to the viewer.
In the DE 30 02 067 A1, an apparatus is disclosed, which permits an essentially fully automatic examination of a female breast. The apparatus comprises a couch with a resting surface, in which an opening has been provided. On the side of the couch, averted from the resting surface, a container is disposed, which is filled with water as coupling medium. Furthermore, a holding arm with at least one ultrasonic transducer is provided in the container. The holding arm is driven mechanically or electrically and carries out a semicircular swiveling motion, the center of which corresponds approximately to the center of the opening in the couch or is a few centimeters perpendicularly above the center of the plane of the opening in the interior of the thorax of the patient. During a swiveling motion of the holding arm carrying the or each ultrasonic transducer, a two-dimensional, level layer image is produced and stored in a memory unit. Furthermore, a transporting unit is provided for shifting the or each ultrasonic transducer, perpendicularly to the plane of swiveling of the holding arm or to the rotation of the swiveling plane about a common axis, by in each case a predetermined path length, so that series of level sectional images can be stored in a memory unit together with an assigned data value, corresponding to the respective shifting.
During the swiveling motion of the or each ultrasonic transducer about the breast, layer regions are scanned repeatedly, so that, because of the redundancies, averaging methods are required for representing the image. Admittedly, this method brings about a reduction in the interfering artifacts and permits all neighboring regions of strongly reflecting or reinforcing particles to be viewed. However, the occurrence of tail-like image patterns in two-dimensional sectional images, which is desirable with respect to a simplified diagnosis, is suppressed almost completely due to the averaging of the recording. Furthermore, the long measuring time of the apparatus disclosed here is a disadvantage, since the or each ultrasonic transducer, for recording a two-dimensional sectional image, already must be passed on a semicircular path about the breast, which is to be examined. Moreover, the movement of the holding arm causes a displacement, which in turn leads to a movement of the breast to be examined and, with that, to a deterioration in the quality of the layer image recorded.
From the DE 30 15 837 A1, an ultrasonic imaging apparatus with an ultrasonic transducer device is known, which has separate transducers for sending and receiving ultrasound. The height of the disclosed transducer device can be varied and the device is disposed in a water container and has a transporting unit for shifting the transducer laterally or on a circular path around the structure, which is to be examined.
From the journal “Fortschritte auf dem Gebiet der Rontgenstrahlung (Progress in the Field of X Radiation)”, 147, 3 in the year 1987 in the article “Clinical Experience with Ultrasonic Reflection Computer Tomography of the Breast” by M. Friedrich, F. Fobbe and A. Sparenberg on pages 298 to 303, a method is disclosed for which the patient, resting on a couch, immerses the breast, which is to be examined through an opening in the couch into a water bath. Furthermore, an ultrasonic transducer with four individual sound heads of different focal length is disposed in the waterbath. It is passed by a transporting unit by a predetermined path length on circular scanning paths about the breast protruding into the water bath. By shifting the ultrasonic transducer, any sectional images of the breast, which is to be investigated, can be produced. With the help of an averaging method, which is unavoidable with this scanning procedure because of redundancies, a reduction in image artifacts furthermore is made possible. Aside from the absence of tail-like image patterns due to the image averaging, the passing of the ultrasonic transducer on circular paths around the breast that is to be examined and the therewith associated long recording time, required for recording a two-dimensional sectional image, are disadvantages.
In the DE 80 10 553 U1, an ultrasonic diagnostic de

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