Data processing: generic control systems or specific application – Generic control system – apparatus or process – Digital positioning
Reexamination Certificate
1996-09-30
2001-06-19
Gordon, Paul P. (Department: 2121)
Data processing: generic control systems or specific application
Generic control system, apparatus or process
Digital positioning
C700S058000, C700S062000, C700S066000, C700S302000, C378S042000
Reexamination Certificate
active
06249713
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a system, apparatus, and method for accurate positioning of a surgical tool, such as a biopsy needle, with respect to a deep seated target inside a patient and, more specifically, a positioning device that takes as its input a needle entry point and a target point selected on the screen of a fluoroscope for automatically positioning a needle guide and indicating the depth to the target point.
REFERENCE TO OTHER APPLICATIONS
The subject matter of the following copending patent applications being filed on even date herewith is closely related to the subject matter of the present application and is incorporated herein by reference to the extent it is not incompatible with the present disclosure: APPARATUS AND METHOD FOR POSITIONING A BIOPSY NEEDLE Ser. No. 08/722,705, now U.S. Pat. No. 5,766,127 issued Jun. 16, 1998, APPARATUS AND METHOD FOR DETERMINING THE CORRECT INSERTION DEPTH FOR A BIOPSY NEEDLE Ser. No. 08/722,708, now U.S. Pat. No. 6,097,994 issued Aug. 1, 2000, and TRIGONOMETRIC DEPTH GAUGE FOR BIOPSY NEEDLE Ser. No. 08/722,724 now abandoned Sep. 10, 1998. All are filed in the names of Navab and Geiger, the present inventors, and all a re assigned to Siemens Corporate Research, Inc., as is the present application.
DESCRIPTION OF RELATED ART
Needle biopsy is one of the most frequent surgical interventions. Typically, a fine needle is used to remove tissue portions from a lesion inside the body. If the lesion is very small and is deep-seated within the body or is not palpable, the surgeon needs guidance in order to make sure that the tip of the needle reaches the desired location.
Currently used image based guidance methods include the following. Ultrasound (US), X-ray fluoroscopy, CT (computerized tomography) fluoroscopy, and CT/MRI (computerized tomography/magnetic resonance imaging) in combination with real time registration tools. The first three methods provide real time intra-operative images of the patient and enable the surgeon to see the needle as it approaches the target.
Ultrasound is relatively inexpensive and is a readily available image modality. However, its usage for guidance is limited to lesions that are close to the skin and that show a well defined signal.
The X-ray fluoroscope is a widely available, low cost two-dimensional (2D) imaging equipment. Since it shows a two-dimensional projection, two (generally orthogonal) views are necessary in order to determine the biopsy needle position. This can be done by turning the arm of a simple fluoroscope, such as a C-arm fluoroscope, an example of which is shown in
FIG. 1
, or by using a fluoroscope such as that illustrated in
FIG. 2
that provides two simultaneous orthogonal views. Since the needle has to be manipulated in the image field, one cannot avoid a X-ray exposure of the physician when using such techniques. As is well-known, unnecessary exposure of health workers to X-ray radiation is believed to be hazardous to health and it is desirable that it should be avoided to the extent possible.
CT-Fluoroscopy permits real-time display of CT images. The physician controls X-ray exposure during continuous tube rotation. The exact position of the needle can be traced by moving the table. In the case for CT-Fluoroscopy also, the surgeon is exposed to X-rays.
CT/MRI in combination with real time registration tools is based on pre-operative 3-D data acquisition (CT or MRI). The lesion is outlined in the resulting dataset. During the actual biopsy, the position and orientation of the patient and the needle have to be known precisely and aligned with the pre-operative data.
Therefore two registrations have to be used for guiding the needle: the pre-operative data showing the lesion has to be registered with the patient. This can be done by attaching invariant markers to the patient (stereo-tactic frames) before data acquisition or by matching invariant patient features, such as the skull or bones.
The needle has to be registered with the patient. One possibility is to attach optical markers to the needle which can be tracked by a system of cameras or by X-ray fluoroscopy, or to use mechanical devices like passive robot arms that register the position of the needle at any moment. This technique requires highly specialized and costly 3-D imaging facilities that are typically only available at a few research sites. Despite the image guidance, a successful biopsy procedure still depends on the manual skills and judgement of the surgeon who is manipulating the needle.
SUMMARY OF THE INVENTION
There is a need herein recognized for an alignment device that is adjustable to the right direction and that indicates the distance to a deep-seated target. Among the benefits that result from such a device are acceleration of the procedure, increase of the safety of the procedure, and reduction of radiation exposure for both the patient and for the surgeon.
In accordance with the objects of the present invention, an X-ray image guided system provides assistance in the execution of needle biopsy. It can also be used for minimal access surgical procedures, known as “keyhole surgery”. One of the objects of the present system, which is simple and readily implemented, is to help surgeons overcome difficulties associated with positioning the biopsy needle or performing minimally invasive surgery in three dimensions while utilizing two-dimensional images for guidance in the procedure.
Another object of the present invention is to practically eliminate or reduce to a minimum the need for a surgeon's reliance on a radiologist to open an access track pre-operatively in the radiology suite.
Furthermore, another object of the invention is to practically eliminate the need for accurate geometrical calibration. The present invention is believed to provide a first opportunity in which quantitative imaging guidance is made possible without a dedicated geometrical calibration procedure.
The invention permits the accurate positioning of a surgical tool, such as biopsy needle, with respect to a deep seated target inside a patient. It is the practical application of an algorithm in accordance with the invention which makes the accurate positioning possible.
Based on geometrical reasoning involving a mechanical device, simple in conception, in accordance with the invention, biopsy needles may be considered in the context of the invention as an adjunct to traditional medical imaging systems such as C-arm equipment and fluoroscopes.
Generally, a preferred position for a biopsy needle from the surgical point of view is a position above the patient from which it goes through the organ of interest. In addition, the surgeon needs to know the depth of the target in order to correctly insert the needle.
In accordance with an aspect of the invention, apparatus for automatically positioning a guide for a biopsy needle for its proper insertion into the body of a patient from a selected point on a surface of the body, so as to enter in a straight line passing through a designated target region within the body, in conjunction with an imaging system utilizing radiation from a first source position for deriving a first radiographic image on a first image plane of a portion of the body including a first image of the selected point and a first image of the target region; wherein the first source position, the first image of the selected point, and the first image of the target region defining a first viewing plane &pgr;, the imaging system utilizing radiation from a second source position for deriving a second radiographic image on a second image plane of the portion of the body, including a second image of the selected point and a second image of the target region; wherein the second source position, the second image of the selected point, and the second image of the target region defining a second viewing plane &pgr;′, the guide being constructed so as to be identifiable by its guide image on the radiographic images, at least as to its direction, comprises controllable apparatus for moving the guid
Geiger Bernhard
Navab Nassir
Ahmed Adel A.
Gordon Paul P.
Siemens Corporate Research Inc.
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