Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
2001-10-12
2003-04-08
Lateef, Marvin M. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S410000, C600S411000, C600S417000, C600S424000, C600S428000, C600S434000, C600S437000, C600S439000, C606S130000
Reexamination Certificate
active
06546279
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to interventional medicine, and particularly concerns properly locating, vectoring, and inserting a needle-like medical device toward and into a targeted patient anatomic feature while the patient is being imaged with single, or multi-modality medical imaging equipment such as computed tomography imaging (CTI) equipment, magnetic resonance imaging equipment (MRI), fluoroscopic imaging equipment, and 3D ultrasound equipment.
Among others, Frank J. Bova and William A. Friedman of the present inventors have pioneered the art of high precision planning and treatment of intracranial targets using radiation originating from medical linear accelerators. All of these previously developed planning and treatment systems have been based upon a rigid model consisting of the patient's skull, upper dentisia and intracranial anatomy. Exemplary of these systems and methods are those described in U.S. patent application Ser. No. 09/621,868, filed Jul. 21, 2000, and in the following U.S. Pat. Nos., all issued to the Bova and Friedman on the indicated dates, assigned to the assignee of the present application, the entire contents and disclosures of all of which are incorporated herein by reference:
5,954,647
Marker system and related stereotactic
Sep. 21, 1999
procedure
5,588,430
Repeat fixation for frameless stereotactic
Dec. 31, 1996
procedure
5,189,687
Apparatus for stereotactic radiosurgery
Feb. 23, 1993
5,027,818
Dosimetric technique for stereotactic
July 02, 1991
radiosurgery
Although this rigid model is valid for cranial targets, it is not practical for all anatomic regions. An example of a target that cannot be modeled with a rigid body modality is metastatic disease within the liver. In order to effect the application of high precision biopsy, radiation treatments or other medical procedures to such deformable anatomic regions, real time imaging of the target region must be incorporated into the treatment procedure.
Multiplanar x-rays and ultrasound are the best suited of all of the modalities available for such real time imaging. Multiplanar x-ray imaging, primarily orthogonal imaging, has been used to localize radiation targets for several decades. While this mode of target localization has several advantages, its primary disadvantages are the space and time it requires. The space required by the imaging chain, including x-ray source(s) and imaging electronics, is simply not available near or around a patient who is in position for real time treatment, especially if the treatment uses a medical linear accelerator. Depending on how fast an image of a given portion of the anatomy changes with time and the time required to complete a multiplanar x-ray process, the x-ray imaging may not be sufficiently fast to track changes and provide accurate real time data.
U.S. Pat. No. 5,893,832, issued to Song on Jun. 24, 1997, describes an ultrasound probe which provides a 3D image of an anatomic region without external probe movement. The probe effectively provides a 3D image of a selected anatomic region without the necessity for external probe movement. Ultrasound probes like those of the Song patent can provide real time imaging of a portion of the patient's anatomy, although the image data is with reference to the position of the ultrasound probe. As the ultrasound probe is moved, the point of reference changes.
U.S. patent application Ser. No. 09/621,868, filed Jul. 21, 2000 describes a system which enables image guidance during radiation therapy and surgery, by combining an ultrasound probe with both passive and active infrared tracking systems for production of a 3D image. The combined system enables a real time image display of the entire region of interest without probe movement. The system enables probe displacement during image acquisition so that all external displacements introduced by the probe can be accounted for at the time of placement of elements in support of a treatment protocol. This is accomplished by registration of a patient's real world anatomy with the patient's virtual world imaging study. The coordination of these two worlds allow for a clinician to perform a procedure in the virtual world and then, with the aid of computer guidance execute the procedure in the real world.
The first application of linking the real world with the virtual world was the establishment of stereotactic neurological procedures based upon rigid stereotactic frames. Frameless virtual guidance technology has also been established for several operative environments. Intracranial procedures, based upon CTI and or MRI scans have been available for several years. The same CTI or MRI based guidance have also been available for planning and guidance in spinal surgery. Recently, imaging support for the virtual environment has been extended to include virtual fluoroscopy. At the University of Florida the incorporation of both 2D and 3D ultrasound has now been made available for virtual procedures. This form of guidance is employed in many daily procedures including brain tumor biopsy, brain tumor resection, deep brain stimulation, pallidotomy for Parkinson's disease, lesioning procedures for pain, pedicle screw fixation, guidance for ENT surgical procedures, radiosurgery and stereotactic radiotherapy.
What is needed, is the extension of this technology to image guidance during biopsy. It is desirable to reapply the tools used to project a virtual surgical, or radiation, tool to a biopsy needle. More particularly, it is desirable to apply CTI, MRI, fluoroscopy and ultrasound procedures, either independently or in combination, i.e., multi modality imaging, to guidance and placement of a biopsy needle.
SUMMARY OF THE INVENTION
The present invention is described in terms of two embodiments, the first of which is a computer controlled system for guiding a needle device, such as a biopsy needle, by reference to a single mode medical imaging system employing any one of computed tomography imaging (CTI) equipment, magnetic resonance imaging equipment (MRI), fluoroscopic virtual imaging equipment, or 3D ultrasound equipment. The second embodiment is a computer controlled system for guiding the needle device by reference to a multi-modal system, which includes any combination of the above-listed systems.
In the first embodiment, the method of the present invention includes use of a needle device 3D image data set including 3D geometry of the needle device in conjunction with a data set obtained from a single image system, wherein the needle device is configured to be carried by a needle device carrier. The needle device carrier is configured to move in orthogonal coordinate directions relative to a fixed frame of reference so that a current digital positional description of the needle device carrier can be identified with respect to the fixed frame of reference, which is with reference to the real world patient's position.
A broad description of the first embodiment is directed to the steps of imaging at least a portion of a patient with an imaging device to provide a set of patient imaging data, the set of patient imaging data having a fixed frame of reference relative to the patient, combining an image of the needle device with the set of patient imaging data to provide a combined image data set, calculating a desired combined image data set corresponding to a desired position of the needle device relative to the patient and the fixed frame of reference and causing relative movement between the patient and the needle device, based on the desired combined image data set, to bring the needle device position data set into registry with the desired position of the needle device.
In a more detailed description of the first embodiment, the method includes the step of securing a plurality of patient position markers fixed relative to a patient, the patient position markers defining a fixed frame of reference. At least a part of the patient is imaged using an imaging device to provide a set of patient imaging data, the se
Bova Frank J.
Friedman William A.
Clarke Dennis P.
Lin Jeoyuh
Miles & Stockbridge
University of Florida
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