Location sensing with real-time ultrasound imaging

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

Reexamination Certificate

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C600S437000, C600S443000, C600S462000, C600S466000

Reexamination Certificate

active

06773402

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates generally to systems and methods for three-dimensional mapping and reconstruction, and specifically to mapping and reconstruction of the interior of body organs, such as the heart.
BACKGROUND OF THE INVENTION
Methods for three-dimensional geometrical mapping and reconstruction of the endocardial surface are known in the art. For example, U.S. Pat. No. 5,738,096, whose disclosure is incorporated herein by reference, describes methods for mapping the endocardium based on bringing a probe into contact with multiple locations on a wall of the heart, and determining position coordinates of the probe at each of the locations. The position coordinates are combined to form a map of at least a portion of the heart. These methods are effective and accurate, but they require substantial time and skill to carry them out.
PCT Patent Publications WO 99/05971 and WO 00/07501 to Willis et al., which are incorporated herein by reference, describe the use of ultrasound transducers on a reference catheter to locate ultrasound transducers on other catheters (e.g., mapping or ablation catheters) which are brought into contact with the endocardium.
A variety of methods have been developed for non-contact reconstruction of the endocardial surface using intracardial ultrasonic imaging. These methods typically use a catheter with a built-in, miniaturized ultrasonic imaging array or scanner. For example, PCT Patent Publication WO 00/19908, whose disclosure is incorporated herein by reference, describes a steerable transducer array for intracardial ultrasonic imaging. The array forms an ultrasonic beam, which is steered in a desired direction by an active aperture. Similarly, U.S. Pat. No. 6,004,269, whose disclosure is also incorporated herein by reference, describes an acoustic imaging system based on an ultrasound device that is incorporated into a catheter. The ultrasound device directs ultrasonic signals toward an internal structure in the heart to create an ultrasonic image.
Further examples of intracardial ultrasonic imaging are presented in U.S. Pat. No. 5,848,969 and in PCT Patent Publication WO 98/18388, whose disclosures are incorporated herein by reference. These publications describe systems and methods for visualizing interior tissue regions using expandable imaging structures. The structures assume an expanded geometry once inside the heart, which stabilizes an associated imaging probe or array.
U.S. Pat. No. 5,797,849 and PCT Patent Publication WO 99/58055, whose disclosures are also incorporated herein by reference, describe methods for carrying out medical procedures using a three-dimensional tracking and imaging system. The position of a catheter or other probe inside the body is tracked, and its location relative to its immediate surroundings is displayed to improve a physician's ability to precisely position it. Various procedures using such a probe are described in these publications. One such procedure is ultrasonic imaging, using an ultrasound imaging head with transducers held outside the body to image an area inside the body in which a probe with a position sensor is located.
Various methods are known in the art for enhancing ultrasonic images and for extracting information, such as three-dimensional contours, from such images. These methods typically combine information from multiple two-dimensional images to define three-dimensional features. For example, PCT Patent Publication WO 99/55233, whose disclosure is incorporated herein by reference, describes a method for defining a three-dimensional surface of at least a portion of a patient's heart using a plurality of images in different planes. The images are made using an ultrasound transducer at known positions and orientations outside the patient's body. Anatomical landmarks are manually identified in the plurality of images.
Other methods of contour extraction and three-dimensional modeling using ultrasonic images are described in European Patent Application EP 0 961 135 and in Japanese Patent Application JP 9-285465, whose disclosures are also incorporated herein by reference. As another example, PCT Patent Publication WO 98/46139, whose disclosure is incorporated herein by reference, describes a method for combining Doppler and B-mode ultrasonic image signals into a single image using a modulated nonlinear mapping function.
U.S. Pat. No. 5,846,205 to Curley et al., which is incorporated herein by reference, describes a phased-array ultrasonic transducer assembly mounted on a catheter. An end portion is attached to the catheter around a transducer array, and the end portion defines an acoustic window which is essentially non-focusing to ultrasonic energy passing therethrough. Because the acoustic window is non-focusing, a relatively small radius of curvature can be used on the radially outer surface of this window.
U.S. Pat. No. 6,066,096 to Smith et al., which is incorporated herein by reference, describes imaging probes and catheters for volumetric intraluminal ultrasound imaging. Apparatus configured to be placed inside a patient includes an elongated body having proximal and distal ends, with an ultrasonic transducer phased array connected to and positioned on the distal end of the elongated body. The ultrasonic transducer phased array is positioned to emit and receive ultrasonic energy for volumetric forward scanning from the distal end of the elongated body. The ultrasonic transducer phased array includes a plurality of sites occupied by ultrasonic transducer elements. At least one ultrasonic transducer element is absent from at least one of the sites, thereby defining an interstitial site. A tool is positioned at the interstitial site. In particular, the tool can be a fiber optic lead, a suction tool, a guide wire, an electrophysiological electrode, or an ablation electrode.
U.S. Pat. No. 6,059,731 to Seward et al., which is incorporated herein by reference, describes a simultaneous side-and-end viewing ultrasound imaging catheter system which includes at least one side array and at least one end array. Each of the arrays has at least one row of ultrasonic transducer elements. The elements are operable as a single ultrasound transducer which are phased to produce different views.
U.S. Pat. No. 5,904,651 to Swanson et al., which is incorporated herein by reference, describes a catheter tube which carries an imaging element for visualizing tissue. The catheter tube also carries a support structure, which extends beyond the imaging element for contacting surrounding tissue away from the imaging element. The support element stabilizes the imaging element, while the imaging element visualizes tissue in the interior body region. The support structure also carries a diagnostic or therapeutic component to contact surrounding tissue.
U.S. Pat. No. 5,876,345 to Eaton et al., which is incorporated herein by reference, describes an ultrasonic catheter for two dimensional imaging or three-dimensional reconstruction. An ultrasonic catheter including at least two ultrasonic arrays having good near and far field resolution provides an outline of a heart chamber, in order to assist in interpreting images obtained by the catheter.
U.S. Pat. No. 6,228,032 to Eaton et al., which is incorporated herein by reference, describes a steering mechanism and steering line for a catheter-mounted phased linear array of ultrasonic transducer elements.
U.S. Pat. No. 6,226,546 to Evans, which is incorporated herein by reference, describes a catheter location system for generating a three dimensional map of a part of a human body, from which three dimensional map a position of the catheter may be determined. A plurality of acoustic transducers are disposed about the catheter head at predetermined locations. A signal processing unit generates the three dimensional map responsive to signals received by a plurality of acoustic transducers acting as acoustic receivers, which acoustic signals were generated by at least one of said plurality of acoustic transducers acting as an acoustic s

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