Stereotaxy systems

Abstract: In a stereotaxy system and method an exoskeleton material (12), such as a thermoplastic mesh, is heat softened and the heat softened material stretched over and conformed to a soft region of a subject, e.g. a patient's breast. The material is allowed or caused to set or harden and is affixed (14) to a support (10) such that the soft tissue is firmly constrained. Magnetic resonance visible markers (18) are affixed to the exoskeleton material adjacent the soft tissue. The patient is examined with a magnetic resonance or other imaging device (20) to generate a three-dimensional image representation (28) for display on a monitor (32). Using the markers, a wand (40) with emitters (42) and receivers (44), and a coordinate system relationship processor (48) determines a relation or transform between a coordinate system of the patient and a coordinate system of the image displayed on the monitor. A trajectory for a biopsy, resection, or the like, is planned using a guide (50). Emitters (52) on the guide are activated to generate a corresponding human-readable trajectory display through the image displayed on the monitor. After repositioning the guide as necessary, an appropriate trajectory and depth through the patient is selected from the human-readable display. An appropriate medical instrument (64) is inserted along the guide to perform the biopsy, resection, or other medical procedure.

Description: This invention relates to stereotaxy systems for breast surgery. Three-dimensional diagnostic image data of selected regions of a human patient are commonly available with magnetic resonance imagers, CT scanners, and other medical diagnostic equipment. These imaging modalities provide structural detail with a resolution of a millimeter or better. Various stereotaxy procedures have been developed which require extreme accuracy. One of the difficulties which has arisen is accurately determining an accurate spatial correlation between the medical diagnostic image and the patient. Stereotaxy has found particular application in neurosurgical procedures. Neurosurgery includes numerous procedures which require extreme accuracy, such as guided-needle biopsies, shunt placements, craniotomies for lesion or tumor resection, and the like. A mechanical ring or frame was attached to the patient's skull before images were taken, from which the name "framed" stereotaxy has evolved. This frame was typically attached to the patient using various mounting hardware methods that include sharp points or pins that pierce the skin and locate into the skull. The frame carried a "localizer" that includes various adjustable, but lockable hardware elements, angle indicators, and the like which enabled a surgical instrument or a guide for the surgical instrument to be mounted in a selected position relative to the patient. Due to the presence of the localizer during the diagnostic imaging, the localizer was visible in the resultant images. Hence, the relationships between the diagnostic image data, the frame, the localizer, and the patient were precisely known. Rather than using a mechanical frame which pierced the skin, other constructions which hold the head immovably in the registered position have also been proposed. One such restraint included a base plate or support for the back of the head made of perspex acrylic. A mask of open mesh was stretched over the patient's face and rigidly affixed to the base. For accurate conformity with individual patients, the mask was configured of a thermoplastic material which could be softened in hot water, stretched or molded into conformity with the patient's face, and connected to the base plate. When the plastic mesh material was cooled it set and the patient's head was rigidly positioned. The prior art neurosurgery frames or other restraints relied on the patient's internal skeleton, such as the skull, as an integral part of its position maintenance system. Breast tissue, lacking an internal skeleton has typically been handled differently. For x-ray mammographic examinations, the tissue has commonly been clamped between a pair of plates causing significant patient discomfort. In one technique for biopsies or resections, a stereotactic frame was associated with the plates and the radiologist inserted a probe carrying a barbed wire to the lesion or tumor to be resectioned or biopsied. Because the wire was barbed, its end would hold its position even after the plates were removed. The surgeon, in a separate procedure with the plates removed, followed the wire to the lesion or tumor. An additional problem with this technique is that the surgeons often found the wire did not define the best approach to the tumor or lesion. Generally, the plates constrained the radiologist's approaches. Moreover, the extreme distortion caused by the plates interfered with selection of the best approach. One problem with x-ray mammography is that it has difficulty distinguishing among soft tissue types. There is a generally poor contrast between "dense" breast tissue found in about 8% of women and lesions or tumors. Scars from prior treatment are also difficult to distinguish from tumors or lesions. Magnetic resonance is ideally suited for examining soft tissue and distinguishing among various types and conditions. However, in order to maintain an accurate registration between the soft tissue and resultant images, it has again been proposed to use non-ferrous radiographic style clamping plates. The clamping plates again have the above-described problems, whether used for radiology or magnetic resonance imaging. It is an object of the present invention to provide a stereotaxy system which overcomes the above problems. WO-A-91/04711, which corresponds to the preamble of claim 1, discloses a computerised surgical operating system consisting of a display unit which gives a three-dimensional image of the structure, and a system for marking the image with reference points, which are fed to a second computer controlling the surgical instrument. The initial image is built up from a data file of digitalised two-dimensional images produced from scans, and this is used to direct the operating instrument accurately towards the operating site. The operating instruments are controlled by a mechanical arm, and can comprise trepanning instruments, needles and implants, laser or radio beam emitters and viewing instruments. The system is for surgical operation on a non-homogenous structure, e.g. the human cranium. According to the present invention there is provided a stereotaxy system comprising: a support for supporting a human subject; an imaging system for generation of a volumetric electronic image representation of at least a soft portion of said subject when supported on said support; markers which are imageable by the imaging system disposed in a fixed position relative to the soft portion of the subject such that the imaging system images the markers along with the soft portion of the subject in the volumetric electronic image representation; an image processor which converts selected portions of the volumetric image representation to a human-readable display of the soft portion of the subject and the markers; a coordinate system transform for establishing a transform relationship between a coordinate system of the human-readable display of the volumetric image representation and a coordinate system of the soft portion; and a guide for defining a trajectory along which an instrument may be inserted into the soft portion; characterized in that said system further comprises: a non-ferrous exoskeleton material which has a stretchable state in which it is stretched to conform to a breast of said human subject when being treated; and affixing means for fixing the exoskeleton material relative to said support such that when said subject is supported by said support said breast is constrained by said exoskeleton material against movement thereof caused by said insertion of said instrument into said breast, said exoskeleton material being relatively rigid when it is fixed relative to said support. The exoskeleton material suitably includes a thermoplastic mesh that is thermally softenable to enable it to be conformed to the breast and sets to a relatively rigid state after conforming to the breast. In one particular system according to the invention the non-invasive imaging system is a magnetic resonance imaging system, and the guide is non-ferrous. One system in accordance with the invention will now be described, by way of example, with reference to the accompanying drawings in which:- Figure 1 is a diagrammatic illustration of the stereotaxy system; Figure 1A is a detailed view of a sheet of exoskeleton material used in the system of Figure 1; and, Figure 2 is a detailed illustration of a patient restraint and an exemplary surgical tool of the system of Figure 1. Referring to the drawings, in use of the system for carrying out a stereotactic procedure on the breast of a patient, the patient is received on a patient support 10. A rectangular sheet of an exoskeleton material 12 is temporarily softened to become flexible and stretchable. In a preferred embodiment, the exoskeleton material 12 is a mesh of a thermoplastic material which softens at temperatures of about 70° C. The material 12 is held or immersed in hot water until soft. The material 12 is then removed from hot water and allowed to cool to about body temperature. The material 12 is then stretched over and molded to the breast and affixed by clamps or other affixing means 14 to sides of the patient support. Optionally, a base 16 is provided between the patient support and the patient to which the exoskeleton material 12 is affixed (see Figure 2). Thereafter, the material 12 is allowed or caused to set to a relatively rigid state. With the thermoplastic material of the preferred embodiment, the material sets as it cools. However, setting may be accelerated by chilling the material, such as with cold water. Other exoskeleton materials are also contemplated. For example, a plaster impregnated gauze type material may be wet, molded into place, affixed to the base or table, and allowed to cure or set. As another alternative, the exoskeleton material can be a mesh of a very stiff but pliable elastic mesh which is sufficiently stiff to hold the soft tissue of the breast substantially fixed relative to itself. The mesh may be interconnected with more rigid plastic or other non-ferrous inserts. The inserts are preferably apertured to permit easy surgical access therethrough. A plurality of fiducials or other markers 18 are affixed to the exoskeleton material 12. The fiducials 18 carry a material which is readily detected by a magnetic resonance imaging apparatus. In one embodiment, the fiducials 18 are hollow spheres that are filled with a material that is magnetic resonance susceptible and x-ray susceptible such that the patient can be examined by either or both x-ray or magnetic resonance techniques. A plurality of fiducials 18 are positioned to define appropriate reference points around the region of interest. Typically, a minimum of three fiducials 18 are used. Alternately, the exoskeleton material 12 may contain magnetic resonance visible markers at relatively regular intervals. In another embodiment, the exoskeleton material 12 may be itself magnetic resonance or CT imageable. Once the fiducials 18 are secured, such as with an adhesive, the patient support 10, patient, and exoskeleton material 12 are moved into a magnetic resonance imaging system 20. In the illustrated embodiment, the patient support 10 is mounted on tracks or guides for movement between poles 24 of the magnetic resonance imaging system. A magnetic resonance examination is conducted to generate magnetic resonance data which is reconstructed by a reconstruction processor 26 to form a volumetric image representation which is stored in an image memory 28. An image processor 30 selectively accesses the volumetric image memory 28 under operator control to withdraw axial, sagittal, coronal, oblique, or other slice images, as well as volume renderings, and other conventionally displayed magnetic resonance and diagnostic images. The image processor 30 is connected with a monitor 32, such as a video monitor, LCD monitor, or gas plasma monitor. Once the magnetic resonance examination has been completed and the volume image representation generated, the patient is prepared for a surgical procedure. The surgical procedure may be performed right in the magnetic resonance examination apparatus, adjacent the magnetic resonance apparatus, or at a remote location. Because the exoskeleton material maintains the soft tissue of the breast in a fixed position even after the patient has been moved, a high degree of freedom in moving the patient to other venues is accorded. In the illustrated embodiment, the surgical procedure is conducted at the magnetic resonance examination site. First, the coordinate system of the electronic image representation and the coordinate system of the patient are correlated. More specifically, a wand 40 has a plurality of emitters 42 mounted thereon. Suitable emitters include light emitting diodes, lasers, ultrasonic transducers, radio transmitters, and the like. A plurality of receivers 44 are disposed adjacent the patient. The wand 40 is positioned on each of a plurality of the fiducials 18, preferably at least three, and the emitters 42 are caused to emit. The receivers 44 receive the emitted signals and through conventional triangulation, velocity measurement, and analogous techniques, a processor 46 determines the location of the tip of the wand 40, and hence of each fiducial 18 in the receiver or patient coordinate system. More specifically, the processor 46 determines the location of each emitter 42. From the emitter locations and any offset of the emitters 42 from the central axis, a trajectory along a central axis of the wand 40, is determined. From the known dimensions of the wand 40, the location of the tip is readily determined. Alternately, an articulated, mechanical arm digitizer can be used. A coordinate system transform means 48 determines a relationship between the coordinate system of the patient and the image data. With continuing reference to FIGURE 1 and further reference to FIGURE 2, the location of the tumors, lesions, or other structures to be biopsied or resectioned are determined in the electronic image space. That is, the radiologist views the images on the monitor 32 and determines the location of tumors, lesions or the like. The surgeon also views the images on the monitor 32 and plans a surgical approach or trajectory. A stereotaxy guide, such as a needle guide 50, is mounted to the patient support, e.g., the base 16, along a generally proposed trajectory. In one embodiment, the guide has emitters 52 which are actuated. The receivers 44 receive the emitted signals from the guide emitters 52. An image generator 54 causes the image processor 30 to generate an image on the monitor 32 depicting a straight line trajectory from the guide 50 into the patient and a cross-hair referencing a preselected reference point on the guide 50. More specifically, the trajectory is conveyed through the transform means 48 to the image processor 30 such that the trajectory is displayed on the monitor 32 along with the cross-hair indicative of the reference point. In another embodiment, the guide 50 is non-ferrous and has magnetic resonance image portion markers, e.g., at 52. The guide 50 is positioned in the magnetic resonance imager 20 with the patient and an image generated. The markers at 52 appear in the displayed human-readable image. In this embodiment, the image generated derives the trajectory and the reference point from the images of the markers at 52. The surgeon then views a multiplicity of slices and images to determine whether the trajectory intersects the lesion, tumor, or other tissue of interest and whether the trajectory passes through the appropriate tissue. For example, the trajectory is selected to avoid major blood vessels or arteries, damaged tissue, bones, and the like. Commonly, the guide 50 is repositioned one or more times and the process repeated until a satisfactory trajectory is determined. Preferably, the guide 50 is removably supported on a support 56 that includes lockable gimbals, hinges, or the like 58 for selectively positioning the guide 50. Once a satisfactory trajectory is determined, the surgeon moves a cursor control, such as a mouse 60, to move a cursor display on the monitor 32. A gauging device 62 calculates a distance between the cursor controlled by the cursor control and the cross-hairs or other indicator of the reference point on the guide. The operator then selects a biopsy needle 64, or other appropriate surgical implement. A stop 66 is set in accordance with the distance between the cursor and the cross-hairs, i.e., the distance to the tumor or the like. The surgeon then inserts the biopsy needle or other surgical instrument to the appropriate depth, performs the biopsy, resection, or the like, and withdraws the needle. After the operation, the incision is closed according to conventional medical practice and the exoskeleton restraint is removed. With non-ferrous guides and surgical instruments, the surgical procedure is performed at or in the magnetic resonance imager. Alternately, the patient and patient support can be moved to a remote site. A set of receivers 44 are disposed at the remote site for relating the coordinate system of the patient and guide at the remote site to the coordinate system of the images.

Claims: A stereotaxy system comprising: a support (10) for supporting a human subject; an imaging system (20) for generation of a volumetric electronic image representation of at least a soft portion of said subject when supported on said support (10); markers (18) which are imageable by the imaging system disposed in a fixed position relative to the soft portion of the subject such that the imaging system (20) images the markers (18) along with the soft portion of the subject in the volumetric electronic image representation; an image processor (30) which converts selected portions of the volumetric image representation to a human-readable display (32) of the soft portion of the subject and the markers (18); a coordinate system transform (48) for establishing a transform relationship between a coordinate system of the human-readable display of the volumetric image representation and a coordinate system of the soft portion; and a guide (50) for defining a trajectory along which an instrument (64) may be inserted into the soft portion; characterized in that said system further comprises: a non-ferrous exoskeleton material (12) which has a stretchable state in which it is stretched to conform to a breast of said human subject when being treated; and affixing means (14) for fixing the exoskeleton material (12) relative to said support (10) such that when said subject is supported by said support (10) said breast is constrained by said exoskeleton material (12) against movement thereof caused by said insertion of said instrument (64) into said breast, said exoskeleton material (12) being relatively rigid when it is fixed relative to said support (10). A system according to claim 1 including an adjustable mechanical mounting (56) for selectively mounting the guide (50) in a selected orientation relative to said breast; emitters (52) disposed on the guide (50) for sending emitting signals; receivers (44) for receiving the signals from the emitters (52); and a location processor (46) connected with the receivers (44) for determining the location of at least one characteristic point on the guide (50) and a trajectory defined by the guide (50), the location processor (46) being connected with the coordinate system transform means (48) for transforming the characteristic point on the guide (50) and the trajectory into the image coordinate system of the human-readable display and being connected with the image processor (30) for generating a human-readable display of the trajectory and the characteristic point; and an instrument (64) received in the guide (50). A system as set forth in claim 1 or claim 2 wherein the exoskeleton material (12) includes a thermoplastic mesh that is thermally softenable to enable it to be conformed to said breast and sets to a relatively rigid state after conforming to the breast. A system as set forth in claim 1 wherein the imaging system (20) is a magnetic resonance imaging system, and the guide (50) is non-ferrous. A system as set forth in claim 4 wherein at least portions of the guide (50) are imageable in the magnetic resonance imaging system (20), in use of said stereotaxy system, the guide (50) being imaged along with said breast to establish a relationship between a coordinate system of the human-readable display and a coordinate system of the breast and the guide (50).

Inventors: KORMOS DONALD W, PIRAINO DAVID W, KORMOS, DONALD W., PIRAINO, DAVID W.
Applicants: CLEVELAND CLINIC FOUNDATION, THE CLEVELAND CLINIC FOUNDATION
Application year: 1995
Main classification: A61B19
IPC codes: A61B5, A61B6, A61B19