Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
1997-06-13
2001-01-09
Lateef, Marvin M. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S466000, C600S467000, C128S916000
Reexamination Certificate
active
06171247
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to a catheter-based ultrasound imaging device having a rotatable multiplane transducer which can obtain spatially related sets of 2-dimensional images that can be reformatted into a 3-dimensional volumetric image.
BACKGROUND OF THE INVENTION
In the catheter-based ultrasound imaging arena, increasing emphasis is being placed on intraluminal/intracavitary underfluid imaging for the purpose of directing precision therapy and diagnostics. A number of imaging catheter inventions have been proposed over the last few years. The basic concepts of a self-contained ultrasound catheter device have been described in the patents issued to Dr. James B. Seward and A. Jamil Tajik, such as U.S. Pat. Nos. 5,325,860 and 5,345,940, and are incorporated hereby by references. However, at present, underfluid ultrasound technology is principally limited to linear, sector, or cylindrical ultrasound array transducers which are optimized to obtain single tomographic planes of view. Additional planes are usually obtained by manipulation of the catheter or the stacking of images into a data set. Three-dimensional volumetric images have been small and of little clinical utility.
Presently rotatable multiplane arrays are primarily used in large transesophageal echocardiographic probes (see “Multiplane Transesophageal Echocardiography: Image Orientation, Examination Technique, Anatomic Correlations and Clinical Applications” by Seward J. B., et al. Mayo Clinic Proceedings, 68:523-551, 1993) and, to a lesser extent, for surface echocardiographic examinations (see “Multidimensional Ultrasonic Imaging for Cardiology” by McCann H. A. et al. Proc IEEE, 76:1063-1071, 1988; and U.S. Pat. No. 4,543,960 issued to Harui et al.) The patent discloses a catheter-based multiplane (conical data set) echocardiography scanhead. The ultrasound imaging scanhead is rotated to obtain multiple cross-sectional planes from within the cardiovascular system including the heart. This patent also discloses that it is possible to use the scanhead in a manner whereby cross-sectional views of the heart can be obtained along a variety of orientations. These catheter orientations are selectable by the operator while actually viewing the internal cardiovascular and surrounding structures on the monitor to which the scanhead is connected. The catheter-based multiplane echocardiographic technology permits the attainment of sequential tomographic images (i.e., a data set) from the confines of the cardiovascular system. Such multiplane transducers have been used to obtain a spatially sequenced set of images suitable for 3-dimensional image reconstruction (see “Three- and Four-Dimensional Cardiovascular Ultrasound Imaging: A New Era for Echocardiography” by Belohlavek M. et al. Mayo Clinic Proceedings 1993, 68:221-240).
There is a need in the art for a catheter-based intraluminal/intracavital transluminal imaging device capable of generating multiple fields of view while requiring no manipulation of the catheter. There is also a need for a catheter-based imaging device capable of providing spatially sequenced tomographic images that can be formed, i.e. coalesced, into a three-dimensional image by using a catheter-based multiplane array technology. There is further a need for a catheter-based imaging device capable of delivering diagnostic and therapeutic tools into a field of ultrasound generated by a multiplane phased array imaging ultrasound transducer.
SUMMARY OF THE INVENTION
The present invention relates generally to a volumetric, 3-dimensional imaging underfluid catheter system, particularly, to a catheter-based ultrasound imaging device having a rotatable multiplane transducer for the acquisition of sequential tomographic images in a variable arc up to 360 degrees.
The present invention further relates to a self-contained ultrasound catheter device capable of delivering diagnostic and therapeutic tools into a field of ultrasound generated by the rotatable phased array (or sector phased array) imaging ultrasound transducer.
In one embodiment of the present invention, an underfluid diagnostic and/or therapeutic catheter apparatus includes a catheter having proximal and distal ends and a multiplane ultrasound transducer array which is rotatably mounted proximate the distal end of the catheter for rotation about an axis. The multiplane ultrasound transducer array generates a plurality of sequential tomographic image planes which form a 3-dimensional image of an adjacent underfluid structure. The axis of rotation generally lies in the tomographic image planes.
Further in one embodiment, a working port is disposed in the catheter and extends from proximate the proximal end of the catheter to proximate the distal end of the catheter. The working port receives and delivers a medical instrument or other types of a working tool to proximate the distal end of the catheter. In other embodiments, multiple working ports can be disposed in the catheter for receiving and delivering medical instruments or other working tools. The medical instrument(s) or working tool(s) can be diagnostic or therapeutic devices. Exemplary medical instruments include catheters, angiographic catheters, ablation catheters, cutting tools, blades and balloons. Working ports can also be used to deliver medical drugs to localized regions. It is preferred for a working port to have an exit opening adjacent to the field of view of the transducer array so that the operation of the medical instrument(s) or other working tool(s) and the reaction therefrom can be observed in a real-time fashion. In alternative embodiments, no working port is disposed in the catheter. Medical instrument(s) or other working tool(s) at the distal end of the catheter adjacent to the field of view of the transducer array are mounted in such a way that the operation of the medical instrument(s) or other working tool(s) and the reaction therefrom can be observed in a real-time fashion.
Still in one embodiment, the multiplane ultrasound transducer array is a sector phased array. The sector phased array is mechanically or electronically or through other means rotated around an axis of the ultrasound beam which transmits and records the sector images in the sequential imaging planes in a continuous or interrupted sweep up to 360°. The field of view thus formed is a conical-type shaped volumetric field of view.
In one embodiment, the multiplane ultrasound transducer array is mounted facing transversely of a longitudinal axis of the catheter. The axis of rotation is generally perpendicular to the longitudinal axis of the catheter.
In another embodiment, the multiplane ultrasound transducer array is mounted facing along the longitudinal axis of the catheter. The axis of rotation extends generally along the longitudinal axis of the catheter.
Yet in one embodiment, the axis of rotating is offset from the longitudinal axis of the catheter.
The present invention also relates to a method of diagnosing and/or imaging an underfluid structure, comprising the steps of:
providing a catheter apparatus comprising:
a catheter, having a proximal end and distal end, including a body having a longitudinal axis;
a multiplane ultrasound transducer array being rotatably mounted proximate the distal end of the catheter for rotation about an axis;
the multiplane ultrasound transducer array generating a plurality of sequential tomographic image planes which form a 3-dimensional image of an underfluid structure, the axis of rotating lying in the tomographic image planes; and
a working port disposed in the catheter and extending from proximate the proximal end to proximate the distal end of the catheter for receiving a medical instrument, the medical instrument being operable within a field of view of the 3-dimensional image;
positioning the catheter proximate the underfluid structure;
generating the sequential tomographic images which form the 3-dimensional image of the underfluid structure; and
extending the medical instrument out of the working port and operating on the und
Seward James Bernard
Tajik Abdul Jamil
Lateef Marvin M.
Mayo Foundation for Medical Education and Research
Merchant & Gould P.C.
Shaw Shawna J
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