Bone navigation system

Abstract

A system for use during a medical or surgical procedure on a body. The system generates a display representing the position of two or more body elements during the procedure based on a reference image data set generated by a scanner. The system produces a reference image of a body elements, discriminates the body elements in the images and creates an image data set representing the images of the body elements. The system produces a density image of the body element. The system modifies the image data set according to the density image of the body element during the procedure, generates a displaced image data set representing the position and geometry of the body element during the procedure, and compares the density image of the body element during the procedure to the reference image of the body element. The system also includes a display utilizing the displaced image data set generated by the processor to illustrate the position and geometry of the body element during the procedure. Methods relating to the system are also disclosed.

Description

BACKGROUND OF THE INVENTION

[0002] The invention relates generally to systems which generate images during medical and surgical procedures, and in particular, a system for generating images during medical and surgical procedures based on a scan taken prior to the procedure.

[0003] Image guided medical and surgical procedures comprise a technology by which images, obtained either pre-procedurally or intra-procedurally (i.e., prior to or during a medical or surgical procedure), are used to guide a doctor during the procedure. The recent increase in interest in this field is a direct result of the recent advances in imaging technology, especially in devices using computers to generate three dimensional images of parts of the body, such as computed tomography (CT) or magnetic resonance imaging (MRI).

[0004] The majority of the advances in imaging involve devices which tend to be large, encircle the body part being imaged, and are expensive. Although the images produced by these devices depict the body part under investigation with high resolution and good spatial fidelity, their cost usually precludes the dedication of a unit to the performance of procedures. Therefore, image guided surgery is usually performed using images taken preoperatively.

[0005] The reliance upon preoperative images has focused image guidance largely to the cranium. The skull, by encasing the brain, servers as a vessel which inhibits changes in anatomy between imaging and surgery. The skull also provides a relatively easy point of reference to which a localization system may be attached so that registration of pre-procedural images to the procedural work space can be done simply at the beginning of the procedure. Registration is defined as the process of relating pre-procedural images of anatomy to the surgical or medical position of the corresponding anatomy. For example, see U.S. Ser. No. 07/909,097, now U.S. Pat. No. 5,383,454, the entire disclosure of which is incorporated herein by reference.

[0006] This situation of rigid fixation and absence of anatomical movement between imaging and surgery is unique to the skull and intracranial contents and permits a one-to-one registration process as shown in FIG. 1. The position during a medical procedure or surgery is in registration with the pre-procedural image data set because of the absence of anatomical movement from the time of the scan until the time of the procedure. In almost every other part of the body there is ample opportunity for movement which degrades the fidelity of the pre-procedural images in depicting the intra-procedural anatomy. Therefore, additional innovations are needed to bring image guidance to the rest of the body beyond the cranium.

[0007] The accuracy of image guided surgery is based on the identification of structures within the body that do not change shape, do not compress, nor deform between the process of imaging and surgery. Such structures are termed “rigid bodies,” and the bones of the skeleton satisfy this definition for a rigid body. Bones are commonly a target for medical or surgical procedures either for repair, fusion, or biopsy. Therefore, a technique is needed whereby registration can be performed between the bones or bone fragments (skeletal elements) as depicted pre-procedurally on scans and the position of these same skeletal elements as detected intra2 procedurally. This technique must take into account that movement can occur between portions of the skeleton which are not rigidly joined, such as bones connected by a joint, or fragments of a broken bone.

SUMMARY OF THE INVENTION

[0008] It is an object of this invention to provide a system which allows registration between multiple skeletal elements depicted in pre-procedural images and detected during surgery.

[0009] It is a further object of this invention to provide a system which can localize multiple rigid bodies that move with respect to each other between imaging and a procedure and provide a display during the procedure of the bodies in their displaced positions.

[0010] It is another object of this invention to provide a system for use during a medical or surgical procedure on the body, the system generating a display representing the position of two or more body elements during the procedure based on an image data set generated by a scanner prior to the procedure.

[0011] It is another object of this invention to provide a system for use during a medical or surgical procedure on a body which modifies the image data set according to the identified relative position of each of the elements during the procedure.

[0012] It is another object of this invention to provide a system which generates a display representative of the position of a medical or surgical instrument during a procedure in relation to body elements.

[0013] It is a further object of this invention to provide a system for use during image guided medical and surgical procedures which is easily employed by the doctor or surgeon conducting the procedure.

[0014] It is another object of this invention to provide a system which determines the relative position of body elements based on the contour of the body elements which, in some cases, avoids the need for exposing the body elements.

[0015] It is still another object of this invention to provide a system which employs the projected fluoroscopic images of body elements to determine their relative position.

[0016] It is yet a further object of this invention to describe a surgical or medical procedure which employs a display representing the position of body elements during the procedure based on an image data set of the body elements generated prior to the procedure.

[0017] It is a further object of this invention to provide a system and method for medical or surgical procedures which allows repositioning of body elements during the procedure and still permits the generation of a display showing the relative position of the body elements.

[0018] Other objects and features will be in part apparent and in part pointed out hereinafter.

[0019] The invention comprises a system for use during a medical or surgical procedure on a body. The system generates a display representing the position of one or more body elements during the procedure based on one or more reference images. The system comprises a first means for producing the reference image of the one or more body elements. The system includes a means for discriminating a body element in a reference image and creating an image data set representing the position and geometry of the reference image of the one or more body elements. A second means produces, during the procedure, a density image of the one or more body elements. A processor modifies the image data set according to the density image. The processor generates a displaced image data set representing the position and geometry of the body elements during the procedure. A display utilizes the displaced image data set to illustrate the position and geometry of the body elements during the procedure.

[0020] The invention also comprises a system for displaying relative positions of the body elements during a procedure on a body The system includes a processor to discriminate a body elements of a reference image data set to create an image data subset defining position and geometry the one or more body elements. The image data subset has a plurality of data points correlatable to a plurality of reference points for the body elements, the position of reference points of a particular body element relative to the data points for that particular body element is known. The system includes a memory for storing the image data subset. A reference system determines, during the procedure, the position of the reference points of the body element relative to the reference points of the other body elements. A radiographic device produces a two-dimensional radiographic image of the body elements during the procedure which includes the identification of reference points of the body elements. The processor further digitizes the radiographic image. The processor also generates a displaced image data set representing the position of the body elements during the procedure by modifying the image data subset using an iterative process such that a two-dimensional projection through the displaced image data set matches the one or more radiographic images. The system also includes a display utilizing the displaced image data set to display the relative position of the body element during the procedure.

[0021] In another embodiment, the invention includes a system for use during a medical or surgical procedure on a body. The system generates a display from a displaced image data set representing the position of a body element during the procedure based on reference images taken of the body element by a scanner. The invention includes a means for producing an image data set from the reference image of a body element. Another means substantially discriminates the body element in the image data set and creates an image data subset representing the position and geometry of the body element. Another means produces, during the procedure, images of the body element to be displayed. A processor modifies the image data subset of the body element such that a two-dimensional projection through a displaced image data set matches the images during the procedure of the body elements as produced by the producing means. The processor generates the displaced image data set representing the position and geometry of the body element during the procedure. A display utilizes the displaced image data set and illustrates the position and geometry of the one or more body elements during the procedure.

[0022] In another embodiment the invention includes a system for use during a medical or surgical procedure on a body. The system generates a display from a displaced image data set representing an image of a body elements during the procedure based on reference images taken by a scanner, wherein the reference images have contours for the body elements. The system includes a processor substantially discriminates the contour of the body element of the reference image as represented by an image data set and creates an image data subset which defines the position, geometry and contours of the one or more body element. The system includes a determining system which is configured to determine, during the procedure, images and contours of images of the body elements to be displayed. The processor further modifies the image data subset according to the determined contour for body element, during the procedure, as determined by the determining system. The processor generates a displaced image data set representing the position and geometry of the contour of the body element during the procedure. A display utilizes the displaced image data set to illustrate the position and geometry of the body element during the procedure.

[0023] In another embodiment, the invention provides a method for use during a procedure to generate a display representing the position of body elements during the procedure based on a reference image data set. The method includes the steps of creating a reference image of body element and creating a corresponding image data set. Next the method discriminates the body element from the soft tissue in the image data set. The invention then produces a two-dimensional image based on density of the body element. Next the method produces a displaced image data set by modifying the image data set such that a two-dimensional projection through the displaced image data set matches the two-dimensional image during the procedure. Then a display is generated based on the displaced image data set which illustrates the position of the body elements during the procedure.

[0024] In another embodiment, the invention provides a method for use during a medical or surgical procedure on a body. The method generates a display representing the position of body elements during the procedure based on reference images taken of the body elements. First, a reference image of the body element is produced. Then the method discriminates the one or more body elements in the reference images and creates an image data set representing the reference image, position and geometry of the body elements. During the procedure, a density image of the body element to be displayed is produced. The method then generates a displaced image data set representing the position and geometry of the body element during the procedure. To generate the displaced image data set, the method compares the density image of the body element during the procedure to the image data set of the body elements and modifies the image data set according to the density image of the body element during the procedure. Finally, the displaced image data set is displayed thereby illustrating the position and geometry of the body elements during the procedure.

[0025] In yet another embodiment of the present invention, a system displays the relative positions of body elements during a procedure on a body. The system includes a memory for storing an image data set. The image data set represents the position of the body elements based on reference images of the body and has a plurality of data points correlatable to a plurality of reference points for each of the body elements. The position of reference points of a particular body element relative to the data points for that particular body element are known. The invention also includes a reference system for identifying, during the procedure, the position of the reference points of each of the body elements relative to the reference points of the other body elements. The reference system also determines the density of each of the body elements during the procedure. A processor compares the density of each of the body elements during the procedure as determined by a device to the density of each of the body elements as represented by the image data set. The processor modifies the spatial relation of the data points of one body element relative to the data points of another body element according to the identified relative position of the reference points during the procedure as identified by the reference system. The processor also generates a displaced image data set representing the position of the body elements during the procedure. A display utilizes the displaced image data set to display the relative position of the body elements during the procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0026] FIG. 1 is an illustration of the prior art system in which rigid fixation and absence of movement between imaging and surgery permits a one-to-one registration process between the pre-surgical image data set and the position in surgery.

[0027] FIG. 2A is an illustration of operation of the invention in which the pre-procedural image data set is modified in accordance with the intra-procedural position in order to generate a displaced data set representative of the intra-procedural position.

[0028] FIG. 2B is a block diagram of one preferred embodiment of a system according to the invention.

[0029] FIG. 3 is an illustration of the pre-procedural alignment of three body elements during scanning.

[0030] FIG. 4 is an illustration of the intra-procedural alignment of the three body elements of FIG. 3 during surgery.

[0031] FIG. 5 is an illustration of three body elements, one of which has a reference frame attached thereto, in combination with a registration probe.

[0032] FIG. 6 is an illustration showing ultrasound registration according to the invention in which emitters are attached to the patient's body.

[0033] FIG. 7 is an illustration of a fluoroscopic localizer according to the invention for providing projections of an image of the body elements.

[0034] FIG. 8 is an illustration of a drill guide instrument of the invention wherein the position of a drill guide relative to the body elements may be displayed.

[0035] FIGS. 9 and 10 illustrate a clamped reference frame and a wired reference frame, respectively.

[0036] Corresponding reference characters indicate corresponding parts throughout the drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0037] Referring to FIG. 2A, an overview of operation of one preferred embodiment of the system according to the invention is illustrated. Prior to a particular procedure, the body elements which will be part of the procedure are scanned to determine their alignment. For example, the alignment may be such as illustrated in FIG. 3 wherein body elements 10, 20, and 30 are more or less aligned in parallel. These body elements may be bones or other rigid bodies. In FIG. 3, three-dimensional skeletal elements 10, 20, 30 are depicted in two dimensions as highly stylized vertebral bodies, with square vertebra 11, 21, 31, small rectangular pedicles 12, 22, 32, and triangular spinous processes 13, 23, 33. During imaging, scans are taken at intervals through the body parts 10, 20, 30 as represented in FIG. 3 by nine straight lines generally referred to be reference character 40. At least one scan must be obtained through each of the body elements and the scans taken together constitute a three-dimensional pre-procedural image data set.

[0038] FIG. 2B is a block diagram of the system according to the invention. A scanner interface 102 allows a processor 104 to obtain the pre-procedural image data set generated by the scanner and store the data set in pre-procedural image data set memory 106. Preferably, after imaging, processor 104 applies a discrimination process to the pre-procedural image data set so that only the body elements 10, 20, 30 remain in memory 106. If a discrimination process is employed, processor 104 may execute the discrimination process while data is being transferred from the scanner through the scanner interface 102 for storage in memory 106. Alternatively, memory 106 may be used for storing undiscriminated data and a separate memory (not shown) may be provided for storing the discriminated data. In this alternative, processor 104 would transfer the data set from the scanner through scanner interface 102 into memory 106 and then would discriminate the data stored in memory 106 to generate a discriminated image data set which would be stored in the separate memory.

[0039] Once the body elements 10, 20, 30 are discriminated from the soft tissue and each defined as a single rigid body, they can be repositioned by software algorithms, well known in the art, to form the displaced image data set. Each of the body elements 10, 20, 30 must have at least three reference points which are selected by the doctor or surgeon and which are visible on the pre-procedural images. These reference points must be able to be indicated with accuracy during the procedure. For body part 10, reference points 10A, 10B, and 10C are located on the spinous process 13; for body part 20, reference points 20A and 20C are located on the vertebra 21 and reference point 20B is located on spinous process 23; and for body part 30, reference points 30A and 30B are located on the spinous process 33 and reference point 30C is located on the vertebra 31. More than one reference point can be selected on each scan through the bone, although the maximal accuracy of registration is achieved by separating the reference points as far as possible. For example, in the case of posterior spinal surgery, it may be preferable to select reference points 10A, 10B, and 10C on the spinous process which is routinely exposed during such surgery. It is contemplated that work station software may allow the manual or automated identification of these same points on the images of the body elements 10, 20, 30. As FIG. 3 is a two-dimensional simplification of a three-dimension process, the reference points will not necessarily be limited to a perfect sagittal plane, as depicted.

[0040] After imaging, the skeletal body elements 10, 20, 30 may move with respect to each other at the joints or fracture lines. In the procedure room, such as an operating room or a room where a medical procedure will be performed, after positioning the patient for surgery, the body elements will assume a different geometry, such as the geometry depicted in FIG. 4.

[0041] As a result of this movement, the pre-procedural image data set stored in memory 106, consisting of the scans through the skeletal elements, does not depict the operative position of the skeletal elements, as shown in FIG. 4. However, the shape of the skeletal elements, as depicted by the scans through the element, is consistent between imaging and procedure, as indicated by the lines 40 through each element in FIG. 4. Therefore, the image data set must be modified to depict the current geometry of the skeletal elements. This modification is performed by identifying the location of each reference point of each skeletal element in procedure space. As diagrammatically illustrated in FIG. 2B, a localizer 108 identifies the location and provides this information so that the pre-procedural data set may be deformed or re-positioned into the displaced data set. As a result, the displaced data set is in registration with the intra-procedural position of the elements 10, 20, 30. Once the locations of the reference points are determined by the localizer 108, processor 104, which is a part of the work station, can execute software which re-positions the images of the skeletal elements to reflect the position of the actual elements in the procedure room thus forming the displaced set and the registration between the displaced set and the intra-procedural position.

[0042] Preferably, a three-dimensional digitizer may be used as the localizer 108 to determine the position and space of the elements 10, 20, 30 during the procedure. In general, the digitizer would include a reference array 110 which receives emissions from a series of emitters. Usually, the emissions consist of some sort of energy, such as light, sound or electromagnetic radiation. The emitters are applied to and positioned in coordination with the elements being localized and the reference array 110 is distant therefrom, determining the position of the emitters. As is apparent, the emitters may be placed distant to the elements and the reference array 110 may be attached to the elements being localized.

[0043] According to one preferred embodiment of the invention as shown in FIG. 5, a reference frame 116 is attached to one of the skeletal elements 10 at the beginning of the procedure. Reference frame 116 is equipped with a plurality of emitters 114 which together define a three-dimensional procedural coordinate system with respect to the skeletal element 10. Emitters 114 communicate with sensors 112 on a reference array 110 located in the procedure room and remote from the reference frame 116 and patient. If the body of the patient is not immobilized during surgery, then multiple reference frames may be required. The three-dimensional procedural coordinate system may alternatively be defined by rigid fixation of the frame emitters 114 directly (or indirectly, for example, to the skin) to the skeletal elements 10, 20, or 30. In either case, the emitters 114 emit a signal which is received by the sensors 112. The received signal is digitized to compute position, for example, by triangulation. Through such information, the localizer 108 or a digitizer which is part of the localizer 108 can determine the exact three-dimensional position of the frame emitters 114 relative to the sensors 112. The sensors 112 are in a fixed position throughout the procedure, as the reference array 110 is fixed in the procedure room to the ceiling or other support. Thereby, localizer 108 or the processor 104 can exactly determine the position of the reference frame 116 relative to the array. The reference frame 116 is free to move except during localization, e.g., activation of the emitters 114 on the reference frame 116 and activation of the probe emitters 120. Emitters 114 of the reference frame 116 are energized to provide radiation to the sensors 112, which radiation is received and generates signals provided to the localizer 108 for determining the position of the frame 116 relative to the array 110.

[0044] Next, it is necessary to determine the position of the skeletal element 10 to which the reference frame 116 is affixed. In particular, the position of the skeletal element 10 relative to the reference frame 116 must be determined. After exposure of the reference points 10A, 10B, 10C by surgical dissection, the reference points are touched by the tip of a registration probe 118 equipped with emitters 120. As each of the reference points 10A, 10B, 10C is touched by the tip of the probe 120, the emitters are energized to communicate with the sensors 112 of reference array 110. This communication permits the localizer 108 to determine the position of the registration probe 120, thereby determining the position of the tip of the probe 120, thereby determining the position of the reference point 10A on which the tip is positioned. By touching each of the reference points 10A, 10B, 10C on each skeletal element 10, 20, 30 involved in the procedure, and relating them to their corresponding reference points on the images of the same elements, an intra-procedural position data is generated and stored in memory 121. This data is used to derive a transformation which allows the determination of the exact procedural position and orientation of each skeletal element. Using the intra-procedural position of the skeletal elements 10, 20, 30, localizer 108 and processor 104 employ software which manipulates the pre-procedural image data set stored in memory 106 to produce a displaced image data set which is stored in memory 122. The displaced image data set in memory 122 reflects the geometry of the actual elements 10, 20, 30 during the procedure. Processor 104 displays the displaced image data set on display 124 to provide a visual depiction of the relative position of the skeletal elements 10, 20, 30 during the procedure. This image is used by the doctor during the procedure to assist in the procedure. In addition, it is contemplated that an instrument which would be used during the procedure may be modified by the addition of emitters. This modified instrument when moved into the area of the skeletal elements 10, 20, 30 would be activated so that its emitters would communicate with the reference array 110 thereby permitting localizer 108 to determine the instrument's position. As a result, processor 104 would modify display 124 to indicate the position of the instrument, such as by positioning a cursor.

[0045] Reference frame 116 allows the patient to be moved during the procedure without the need for re-registering the position of each of the body elements 10, 20, 30. It is assumed that during the procedure, the patient is immobilized so that the body elements are fixed relative to each other. Since the reference frame 116 is affixed to skeletal element 10, movement of the patient results in corresponding movement of the reference frame 116.Periodically, or after each movement of the patient, array emitters 114 may be energized to communicate with the sensors 112 of reference array 110 in order to permit localizer 108 to determine the position of the reference frame 116. Since the reference frame 116 is in a fixed position relative to element 10 and since we have assumed that elements 20 and 30 are in fixed relation to element 10, localizer 108 and/or processor 104 can determine the position of the elements. From this position, a displaced image data set memory can be created for display on display 124.

[0046] An alternative to touching the reference points A, B, C with the tip of the probe 118 would be to use a contour scanner 126. Such a device, using some form of energy such as sound or light which is emitted, reflected by the contour and sensed, would allow the extraction of a contour of the skeletal elements 10, 20, 30, thus serving as a multitude of reference points which would allow registration to occur. The registration process is analogous to the process described for ultrasound extracted contours below.

[0047] In certain situations, markers may be used on the skin surface as reference points to allow the transformation of the pre-procedural image data set into the displaced image data set. Reciprocally, skin surface fiducials applied at the time of imaging can be used to re-position the body to match the geometry during imaging and is described below.

[0048] Localization of skeletal elements 10, 20, 30 may be desired without intra-procedural exposure of the reference points A, B, C on those skeletal elements. Examples wherein the spine is minimally exposed include percutaneous biopsy of the spine or discectomy, spinal fixation, endoscopy, percutaneous spinal implant insertion, percutaneous fusion, and insertion of drug delivery systems. In this situation, localization of reference points on the skeletal elements must be determined by some form of imaging which can localize through overlying soft tissue. There are currently two imaging techniques which are available to a surgeon in the operating room or a doctor in a procedure room which satisfy the needs of being low cost and portable. Both imaging techniques, ultrasonography and radiography, can produce two- or three-dimensional images which can be employed in the fashion described herein to register a three-dimensional form such as a skeletal element.

[0049] As described in U.S. patent application Ser. Nos. 07/858,980 and 08/053,076, the entire disclosures of which are incorporated herein by reference, the coupling of a three-dimensional digitizer to a probe of an ultrasound device affords benefits in that a contour can be obtained which can be related directly to a reference system that defines three-dimensional coordinates in the procedural work space. In the context of the present invention, a patient is imaged prior to a procedure to generate a pre-procedural image data set which is stored in memory 106. In the procedure room, the patient's body is immobilized to stabilize the spatial relationship between the skeletal elements 10, 20, 30. A reference system for the body is established by attaching a reference array 110 to one of the skeletal elements or by otherwise attaching emitters to the patient or skeletal elements as noted above. For example, this could be performed by using the percutaneous placement of a reference system similar to the one described above, radiopaque markers screwed into the elements or by placing emitters 130 directly on the skins, as illustrated in FIG. 6, based on the assumption that the skin does not move appreciably during the procedure or in respect to the axial skeleton.

[0050] An ultrasound probe 128 equipped with at least three emitters 130 is then placed over the skeletal element of interest. The contour (which can be either two- or three-dimensional) of the underlying bone/soft tissue interface is then obtained using the ultrasound probe 128. This contour of the underlying bone can be expressed directly or indirectly in the procedural coordinates defined by the reference system. Emitters 130 communicate with sensors 112 of reference array 110 to indicate the position of the ultrasound probe 128. An ultrasound scanner 131 which energizes probe 128 determines the contour of the skeletal element of interest being scanned. This contour information is provided to processor 104 for storage in contour memory 132.

[0051] The intra-procedural contour stored in memory 132 is then compared by a contour matching algorithm to a corresponding contour extracted from the pre-operative image data set stored in memory 106. Alternatively, a pre-procedural contour data set may be stored in memory 134 based on a pre-procedural ultrasound scan which is input into memory 134 via scanner interface 102 prior to the procedure. This comparison process continues until a match is found for each one of the elements. Through this contour matching process, a registration is obtained between the images of each skeletal element and the corresponding position of each element in the procedural space.

[0052] In certain instances, the ultrasound registration noted above may not be applicable. For example, ultrasound does not penetrate bone, and the presence of overlying bone would preclude the registration of an underlying skeletal element. Further, the resolution of ultrasound declines as the depth of the tissue being imaged increases and may not be useful when the skeletal element is so deep as to preclude obtaining an accurate ultrasonically generated contour. In these circumstances, a radiological method is indicated, which utilizes the greater penetrating power of x-rays.

[0053] Pre-operative imaging occurs as usual and the skeletal elements are discriminated from the soft tissue in the image data set as above. In particular, a CT scan of the skeletal elements 10, 20, 30 is taken prior to the procedure. Processor 104 may then discriminate the skeletal elements. Next, the patient is immobilized for the procedure. A radiograph of the skeletal anatomy of interest is taken by a radiographic device equipped with emitters detectible by the digitizer. For example, a fluoroscopic localizer 136 is illustrated in FIG. 7.Localizer 136 includes a device which emits x-rays such as tube 138 and a screen 140 which is sensitive to x-rays, producing an image when x-rays pass through it. In general, this screen is referred to as a fluoroscopic plate. Emitters 142 may be positioned on the tube 138, or on the fluoroscopic plate 140 or on both. For devices in which the tube 138 is rigidly supported relative to the plate 140, emitters need only be provided on either the tube or the plate. Alternatively, the reference array 110 may be attached to the tube or the plate. By passing x-rays through the skeletal element 141 of interest, a two-dimensional image based on bone density is produced and recorded by the plate. The image produced by the fluoroscopic localizer 136 is determined by the angle of the tube 138 with respect to the plate 140 and the position of the skeletal elements therebetween. Fluoroscopic localizer 136 includes a processor which digitizes the image on the plate 140 and provides the digitized image to processor 104 for storage in memory 106. Processor 104 may simulate the generation of this two-dimensional x-ray image by creating a two-dimensional projection of the three-dimensional skeletal elements that have been discriminated in the image data set stored in memory 106. In order to form the displaced data set and thus achieve registration, an iterative process is used which re-positions the images of the skeletal elements such that a two-dimensional projection through the displaced data set matches the actual radiographic image. The described process can utilize more than one radiographic image. Since the processor 104 is also aware of the position of the fluoroscopic localizers because of the emitters 142 thereon, which are in communication with localizer 108, the exact position of the skeletal elements during the procedure is determined.

[0054] The above solutions achieve registration by the formation of a displaced image data set stored in memory 122 which matches the displacement of the skeletal elements at the time of the procedure. An alternative technique to achieve registration is to ensure that the positions of the skeletal elements during the procedure are identical to that found at the time of imaging. This can be achieved by using a frame that adjusts and immobilizes the patient's position. In this technique, at least three markers are placed on the skin prior to imaging. These markers have to be detectible by the imaging technique employed and are called fiducials. A multiplicity of fiducials is desirable for improving accuracy.

[0055] During the procedure, the patient's body is placed on a frame that allows precise positioning. Such frames are commonly used for spinal surgery and could be modified to allow their use during imaging and could be used for repositioning the patient during the procedure. These frames could be equipped with drive mechanisms that allow the body to be moved slowly through a variety of positions. The fiducials placed at the time of imaging are replaced by emitters. By activating the drive mechanism on the frame, the exact position of the emitters can be determined during the procedure and compared to the position of the fiducials on the pre-procedural image data set stored in memory 106. Once the emitters assume a geometry identical to the geometry of the fiducials of the image data set, it is considered that the skeletal elements will have resumed a geometric relationship identical to the position during the pre-procedural scan, and the procedure can be performed using the unaltered image data set stored in memory 106.

[0056] In general, instrumentation employed during procedures on the skeleton is somewhat different than that used for cranial applications. Rather than being concerned with the current location, surgery on the skeleton usually consists of placing hardware through bones, taking a biopsy through the bone, or removing fragments. Therefore, the instrumentation has to be specialized for this application.

[0057] One instrument that is used commonly is a drill. By placing emitters on a surgical drill, and by having a fixed relationship between the drill body and its tip (usually a drill bit), the direction and position of the drill bit can be determined. At least three emitters would be needed on the drill, as most drills have a complex three-dimensional shape. Alternatively, emitters could be placed on a drill guide tube 800 having emitters 802, and the direction 804 of the screw being placed or hole being made could be determined by the digitizer and indicated on the image data set (see FIG. 8). The skeletal element 806 would also have emitters thereon to indicate its position.

[0058] Besides modification of existing instrumentation, new instrumentation is required to provide a reference system for surgery as discussed above. These reference frames, each equipped with at least 3 emitters, require fixation to the bone which prevents movement or rotation.

[0059] For open surgery, a clamp like arrangement, as depicted in FIG. 9, can be used. A clamp 900 is equipped with at least two points 902, 904, 906, 908 which provide fixation to a projection 910 of a skeletal element. By using at least two point fixation the clamp 900, which functions as a reference frame, will not rotate with respect to the skeletal element. The clamp includes emitters 912, 914, 916 which communicate with the array to indicate the position of the skeletal element as it is moved during the procedure.

[0060] Many procedures deal with bone fragments 940 which are not exposed during surgery, but simply fixated with either wires or screws 950, 952 introduced through the skin 954. FIG. 10 depicts a reference platform 956 attached to such wires or screws 950, 952 projecting through the skin 954. The platform 956 includes a plurality of emitters 958, 960, 962, 964 which communicate with the array to indicate the position of the bone fragment 940 as it is moved during the procedure.

[0061] The reference frame can be slipped over or attached to the projecting screws or wires to establish a reference system. Alternatively, the frame can be attached to only one wire, as long as the method of attachment of the frame to the screw or wire prevents rotation, and that the wire or screw cannot rotate within the attached skeletal element.

[0062] In view of the above, it will be seen that the several objects of the invention are achieved and other advantageous results attained.

[0063] As various changes could be made in the above without departing from the scope of the invention, it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.

Claims

1. A system for use during a medical or surgical procedure on a body, said system generating a display representing the position and geometry of one or more body elements during the procedure based on one or more reference images, said system comprising: first means for producing the reference image of the one or more body elements; means for discriminating the one or more body elements in said reference image and creating an image data set representing a position and geometry of the reference image of the one or more body elements; second means for producing, during the procedure, a density image of the one or more body elements; a processor modifying the image data set according to the density image said processor generating a displaced image data set representing the position and geometry of the one or more body elements during the procedure; and a display utilizing the displaced image data set illustrating the position and geometry of the one or more body elements during the procedure.

2. The system of claim 1 wherein said second producing means comprises a reference array for providing a reference and means for determining the position of one or more reference points of the body element to be displayed relative to the reference array.

3. The system of claim 2 wherein the second producing means is a radiographic device.

4. The system of claim 3 wherein the radiographic device is a fluoroscopic device comprising a fluoroscopic tube and a fluoroscopic plate.

5. The system of claim 4 wherein the fluoroscopic tube is fixed in relation to the fluoroscopic plate between which the body elements are located for producing the density image of the one or more body elements during the procedure and wherein the processor compares the density image of the one or more body elements during the procedure to the position of the one or more body elements as represented by the image data set.

6. The system of claim 4 wherein the fluoroscopic tube is fixed in relation to a fluoroscopic plate between which the body elements are located for producing the density image of the one or more body elements during the procedure and wherein the processor compares the density image of the one or more body elements during the procedure to the geometry of the one or more body elements as represented by the image data set.

7. The system of claim 4 wherein said fluoroscopic tube has sensors thereon in communication with the reference array and wherein the determining means is adapted to determine the position of the tube relative to the reference array whereby the position of the density image of the one or more body elements can be determined.

8. The system of claim 4 wherein said fluoroscopic plate has sensors thereon in communication with the reference array and wherein the determining means is adapted to determine the position of the plate relative to the reference array whereby the position of the density image of the one or more body elements can be determined.

9. The system of claim 4 wherein said reference array has sensors thereon in communication with the fluoroscopic device and wherein the determining means is adapted to determine the position of the fluoroscopic device relative to the reference array whereby the position of the density image of the one or more body elements can be determined.

10. The system of claim 1 wherein the second producing means is a radiographic device.

11. The system of claim 10 wherein the radiographic device is a fluoroscopic device comprising a fluoroscopic tube and a fluoroscopic plate.

12. The system of claim 11 wherein the fluoroscopic tube is fixed in relation to the fluoroscopic plate between which the body elements are located for producing the density image of the one or more body elements during the procedure and wherein the processor compares the density image of the one or more body elements during the procedure to the position of the one or more body elements as represented by the image data set.

13. The system of claim 11 wherein the fluoroscopic tube is fixed in relation to a fluoroscopic plate between which the body elements are located for producing the density image of the one or more body elements during the procedure and wherein the processor compares the density image of the one or more body elements during the procedure to the geometry of the one or more body elements as represented by the image data set.

14. The system of claim 11 wherein said fluoroscopic tube has sensors thereon in communication with the reference array and wherein the determining means is adapted to determine the position of the tube relative to the reference array whereby the position of the density image of the one or more body elements can be determined.

15. The system of claim 11 wherein said fluoroscopic plate has sensors thereon in communication with the reference array and wherein the determining means is adapted to determine the position of the plate relative to the reference array whereby the position of the density image of the one or more body elements can be determined.

16. The system of claim 1 wherein the processor modifies the image data set to generate the displaced data set using an iterative process such that a two-dimensional projection through the displaced image data set matches the one or more density images during the procedure.

17. A system for displaying relative positions of the one or more body elements during a procedure on a body, the system comprising: a processor for discriminating the one or more body elements of a reference image data set to create an image data subset defining a position and geometry the one or more body elements, the image data subset further having a plurality of data points correlatable to a plurality of reference points for the one or more body elements, the position of reference points of a particular body element relative to the data points for that particular body element being known; a reference system for determining, during the procedure, the position of the reference points of the one or more body elements relative to the reference points of the other one or more body elements; a radiographic device for producing a two-dimensional radiographic image of the one or more body elements during the procedure which includes the identification of reference points of the one or more body elements; wherein the processor further digitizes the one or more radiographic images and generates a displaced image data set representing the position of the body elements during the procedure by modifying the image data subset using an iterative process such that a two-dimensional projection through the displaced image data set matches the one or more radiographic images; and a display utilizing the displaced image data set to display the relative position of the one or more body elements during the procedure.

18. The system of claim 17 wherein the reference system comprises one or more reference frames in communication with a reference array and wherein the one or more reference frames are configured to be fixed in relation to a separate body element and being correlatable to the position of the reference points for each separate body element.

19. The system of claim 18, wherein the radiographic device is equipped with sensors that are in communication with the one or more reference frames whereby the position of the sensors relative to the reference array during the procedure is determined, whereby the position of the radiographic device is determined and whereby the position of the one or more body elements during the procedure is determined.

20. The system of claim 19, wherein the processor translates each of the image data subsets from the position of the one or more body elements as indicated in the image data set to the position of the one or more body elements during the procedure so that the displaced image data set consists of the translated image data subsets.

21. The system of claim 18, wherein the position of the one or more reference frames is known in relation to one of the body elements, and the reference system determines the position of the one or more reference frames relative to the reference array so that the body may be moved during the procedure while the one or more body elements remain in fixed relation to each other and in known relation to the one or more reference frames so that the system can determine the position of the one or more body elements after movement without re-determining the relative position of each of the reference points of the one or more body elements.

22. The system of claim 17 wherein the reference system determines a position of a contour of the one or more body elements during the procedure as represented by the two-dimensional radiographic image and wherein the processor compares the position of the contour of the one or more body elements during the procedure to a position of a contour of the one or more body elements as represented by the image data subset.

23. The system of 17, wherein the radiographic device is a fluoroscopic device comprising a fluoroscopic tube and a fluoroscopic plate between which the one or more body elements are located during the procedure.

24. The system of claim 23, wherein the fluoroscopic device determines a position of the two-dimensional radiographic image of the one or more body elements during the procedure, and wherein the processor compares the position of the two-dimensional radiographic image of the one or more body elements during the procedure to the position of the one or more body elements as represented by the image data subset.

25. The system of claim 23, wherein the fluoroscopic device determines a position of the two-dimensional radiographic image based on a density of the one or more body elements during the procedure, and wherein the processor compares the position of the two-dimensional radiographic image based on the density of the one or more body elements during the procedure to the position of the one or more body elements as represented by the image data subset.

26. The system of claim 23 wherein the fluoroscopic device determines a position of a contour of the one or more body elements during the procedure, and wherein the processor compares the position of the contour of the one or more body elements during the procedure to a position of a contour of the one or more body elements as represented by the image data subset.

27. The system of claim 23 wherein the radiographic device produces a two-dimensional radiographic image based on a density of the one or more body elements.

28. The system of claim 17 wherein the processor further creates a two-dimensional projection image of the body element that has been discriminated in the image data subset.

29. A system for use during a medical or surgical procedure on a body, said system generating a display from a displaced image data set representing the position and geometry of the one or more body elements during the procedure based on reference images taken of the one or more body elements by a scanner, said system comprising: means for creating an image data set from the reference image of one or more body elements; means for substantially discriminating the one or more body elements of the image data set and creating an image data subset representing a position and geometry of the one or more body elements; means for producing, during the procedure, images of the one or more body elements to be displayed; a processor for modifying the image data subset of the one or more body elements to generate a diplaced image data set such that a two-dimensional projection through the displaced image data set matches the images during the procedure of the one or more body elements as produced by the producing means, wherein the displaced image data set represents the position and geometry of the one or more body elements during the procedure; and a display utilizing the displaced image data set and illustrating the position and geometry of the one or more body elements during the procedure.

30. The system of claim 29 wherein the producing means comprises: a reference array for providing a reference; and means for determining the position of the one or more body elements to be displayed relative to the reference array.

31. The system of claim 29 wherein the producing means comprises a device for determining a position of the one or more body elements during the procedure and wherein the processor compares the position of the one or more body elements during the procedure as determined by the device to the position of the one or more body elements as represented by the image data subset.

32. The system of claim 31 wherein the producing means comprises a radiographic device for determining a position of the one or more body elements during the procedure and wherein the processor compares the position of the one or more body elements during the procedure as determined by the device to the position of the one or more body elements as represented by the image data subset, and the position of the one or more body elements may be determined.

33. The system of claim 31 wherein the producing means determines the position of the one or more body elements based on density and wherein the processor compares the density of the one or more body elements during the procedure as determined by the device to the position of the one or more body elements as represented by the image data subset, and the position of the one or more body elements during the procedure may be determined.

34. The system of claim 29 wherein the processor modifying the image data subset transforms the image data subset to represent the position and geometry of the one or more body elements during the procedure, and the displaced image data set consists of the transformed image data subset.

35. The system of claim 29 wherein the processor creates a two-dimensional projection image of the body element that has been discriminated in the image data subset.

36. A system for use during a medical or surgical procedure on a body, the system generating a display from a displaced image data set representing an image of the one or more body elements during the procedure based on reference images taken by a scanner, the reference images having contours of one or more body elements, the system comprising: a processor configured to substantially discriminate the contour of the one or more body elements of the reference image as represented by an image data set by creating an image data subset which represents the contours of the one or more body element; a determining system configured to determine, during the procedure, contours of images of the one or more body elements to be displayed; a processor programmed to modify the image data subset according to the determined contour for one or more body elements during the procedure, the processor generating a displaced image data set representing the contour of the one or more body elements during the procedure; and a display utilizing the displaced image data set to illustrate the position and geometry of the one or more body elements during the procedure.

37. The system of claim 36 wherein the determining system determines the contour based on density.

38. The system of claim 36 wherein the processor is programmed to compare the determined contour of the one or more body elements during the procedure to the contour of the one or more body elements as represented by the image data subset.

39. The system of claim 36 wherein the determining system comprises a radiographic device for determining the contour of the one or more body elements during the procedure and wherein the processor compares the contour of the one or more body elements during the procedure as determined by the radiographic device to the contour of the one or more body elements as represented by the image data subset.

40. The system of claim 36 wherein the modification of the image data subset is such that a contour as determined in a two-dimensional projection through the displaced image data set matches the contour of the images of the one or more body elements during the procedure.

41. The system of claim 36 wherein the processor modifies the image data subset of the one or more body elements such that a contour defined by a two-dimensional projection through the displaced image data set matches the contour of the images during the procedure of the one or more body elements as determined by the determining system.

42. The system of claim 36 wherein the processor further creates a two-dimensional projection of the body element that has been discriminated in the image data subset.

43. A method for use during a procedure, said method generating a display representing the position of body elements during the procedure based on a reference image data set, said method comprising the steps of: creating a reference image of one or more body elements and a corresponding image data set; discriminating the one or more body elements from the soft tissue in the image data set; producing a two-dimensional image based on density of the one or more body elements during the procedure; producing a displaced image data set by modifying the image data set such that a two-dimensional projection through the displaced image data set matches the two-dimensional image during the procedure; and generating a display based on the displaced image data set illustrating the position of the one or more body elements during the procedure.

44. The method of claim 43, further comprising the step of simulating the generation of a two-dimensional image of the body elements by creating a two-dimensional projection of the one or more body elements that had been discriminated in the image data set.

45. The method of claim 43 wherein the step of producing a displaced data set includes modifying the image data set based on density.

46. The method of claim 43 further comprising the step of determining the position of the body elements during the procedure.

47. The method of claim 43 wherein the step of generating a display based on the displaced image data set further comprises the substep of illustrating the geometry of the one or more body elements during the procedure.

48. A method for use during a medical or surgical procedure on a body, said method generating a display representing the position and geometry of one or more body elements during the procedure based on reference images taken of the one or more body elements, said method comprising the steps of: producing a reference image of the one or more body elements; discriminating the one or more body elements in said reference images and creating an image data set representing the position and geometry of the one or more body elements; producing, during the procedure, a density image of the one or more body elements to be displayed; generating a displaced image data set representing the position and geometry of the one or more body elements during the procedure, by comparing the density image of the one or more body elements during the procedure to the image data set of the one or more body elements and modifying the image data set according to the density image of the one or more body elements during the procedure; and displaying the displaced image data set thereby illustrating the position and geometry of the one or more body elements during the procedure.

49. The method of claim 48 wherein the step of producing a density image further comprises the substep of determining the position of one or more reference points of the one or more body elements to be displayed relative to a reference array.

50. The method of claim 48 wherein the step of producing the density image further comprises the substep of determining the position of a fluoroscopic tube and a fluoroscopic plate relative to a reference array and thereby determining the position of the density image of the one or more body elements.

51. The method of claim 48 wherein a reference array has sensors thereon in communication with a fluoroscopic device and wherein the step of producing the density image further comprises the substep of determining a position of the device relative to the reference array whereby the position of the density image of the one or more body elements can be determined.

52. The method of claim 48, further comprising the step of comparing the density image of the one or more body elements during the procedure to the position of the one or more body elements as represented by the image data set.

53. The method of claim 48, further comprising the step of comparing the density image of the one or more body elements during the procedure to the geometry of the one or more body elements as represented by the image data set.

54. The method of claim 48, further comprising the step of comparing a contour of the density image of the one or more body elements during the procedure to a contour of the one or more body elements as represented by the image data set.

55. The method of claim 48, further comprising the steps of: digitizing one or more density images; generating a two-dimensional image by creating a two-dimensional projection of the one or more body elements that have been discriminated in the image data set; and generating a displaced image data set representing the position of the one or more body elements during the procedure by modifying the image data set using an iterative process such that the two-dimensional image matches the one or more density images.

56. The method of claim 48, further comprising the step of creating a two-dimensional projection of the body element that has been discriminated in the image data set.

57. A system for displaying relative positions of body elements during a procedure on a body, the system comprising: a memory storing an image data set, the image data set representing a position and density of the body elements based on reference images of the body, and having a plurality of data points correlatable to a plurality of reference points for each of the body elements, the position of reference points of a particular body element relative to the data points for that particular body element being known; a reference system for identifying, during the procedure, the position of the reference points of each of the body elements relative to the reference points of the other body elements, and wherein the reference system determines a density of each of the body elements during the procedure; a processor comparing the density of each of the body elements during the procedure as determined by a device to a density of each of the body elements as represented by the image data set, and modifying the spatial relation of the data points of one body element relative to the data points of another body element according to the identified relative position of the reference points during the procedure as identified by the reference system to generate a displaced image data set representing the position of the body elements during the procedure; and a display utilizing the displaced image data set to display the relative position of the body elements during the procedure.

58. The system of claim 57, further comprising a medical instrument, wherein the reference system identifies, during the procedure, a position of medical instrument relative to at least one of the body elements, and the display illustrates the position of the medical instrument relative to the body elements based on the identified position of the medical instrument.

59. The system of claim 58, wherein the reference system determines an orientation of the medical instrument relative to the body elements and the display illustrates the orientation of the medical instrument relative to the body elements.

60. The system of claim 57, wherein the reference system comprises one or more reference frames in communication with a reference array and wherein each of the one or more reference frames is configured to be fixed in relation to a separate body element and is correlatable to the position of the reference points for each separate body element.

61. The system of claim 60, further comprising a localizer for determining a position of the reference points of each of the body elements relative to the reference array.

62. The system of claim 61, further comprising a registration probe in communication with the reference array, wherein the localizer determines a position of a tip of the registration probe relative to the reference array and a position of the reference points of each of the body elements can be determined by positioning the tip of the registration probe at each of the reference points.

63. The system of claim 60, wherein the position of the one or more reference frames is known in relation to one of the body elements, and the reference system determines a position of the one or more reference frames relative to the reference array so that the body may be moved during the procedure while the body elements remain in fixed relation to each other and in known relation to the one or more reference frames so that the system can determine a position of each of the body elements after movement without re-identifying the relative position of each of the reference points of each of the body elements.

64. The system of claim 57, wherein the processor discriminates the body elements of the image data set by creating an image data subset representing the position and geometry of each of the body elements.

65. The system of claim 64, wherein the processor translates each of the image data subsets from the position of the body elements as represented in the image data set to the position of the body elements during the procedure so that the displaced data set consists of the translated image data subsets.

66. The system of claim 57, wherein the device comprises an radiographic device.

67. The system of claim 66, wherein the radiographic device is a fluoroscopic device which determines a position of a projection of each of the body elements during the procedure, and wherein the processor compares the position of the projection of the each of the body elements during the procedure to the position of each of the body elements as represented in the image data set.

68. The system of claim 67, wherein the fluoroscopic device comprises a fluoroscopic tube in fixed relation to a fluoroscopic plate between which the body elements are located.