Abstract:
A system and apparatus allows the tracking of a selected body portion, instrument, or both. A tracking device can be interconnected to a body portion at a mounting site. A procedure can be performed at a location remote from the mounting site of the tracking device. The tracking device can be interconnected with the body in a low invasive manner.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application is a continuation of U.S. patent application Ser. No. 10/230,958, filed on Aug. 29, 2002; which is a continuation of U.S. patent application Ser. No. 09/376,712, filed on Aug. 16, 1999, now U.S. Pat. No. 6,477,400; which claims the benefit of both U.S. Provisional Application Ser. No. 60/097,742, filed on Aug. 24, 1998 and U.S. Provisional Application Ser. No. 60/097,183, filed on Aug. 20, 1998. The disclosures of which are hereby incorporated by reference. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     In orthopaedic surgery it is often necessary to insert a guide pin for a cannulated screw, drill bit, or other screw (hereafter referred to as a fixation device) into a bone at a predetermined trajectory. Pre-operative planning depends on two-dimensional radiographic images which typically consist of two views taken at approximately right angles to one another. From these two views it is possible to determine the shape and structure of a long bone. Using that method, the path of insertion for a guide pin for a cannulated screw, drill bit, or screw is accurately determined. However, in practice the actual aiming of a fixation device is an inaccurate art, as the object bone is often seen only at one surface or is not seen at all and, therefore, positioning is dependent on fluoroscopic visualization. This method is also time consuming as the C-arm images must be taken separately and the drapes must be rearranged each time an image is taken. As boney tissue is unyielding, the track of the pin or drill bit is determined by the angular approach before entering the object bone. This angular approach is difficult to determine under normal circumstances and often multiple attempts are needed, as feedback is obtained from repeated fluoroscopic images. Existing methods of calculating the proper angle of guide pin for a cannulated hip screw insertion for hip pinning involve placing data manually into a computer program, which in turn outputs an angle of guide pin for a cannulated hip screw insertion.  
         [0003]     Radiation exposure is a necessary part of any procedure for calculating the proper angle of a guide pin, drill bit, or screw insertion. Radiation exposure is considered to be a hazard. Ionizing radiation has no safe threshold of exposure below which it ceases to have adverse effects, although an arbitrary level is assumed. There has been a recent upward revision of risk estimates of radiation exposure, but absolute levels of safe exposure remain unknown. Exposure to the surgical team as well as the patient during orthopaedic procedures using fluoroscopy is a universal concern. Consequently, a reduction in the amount of radiation exposure is highly desirable.  
         [0004]     Operative stereotactic localization using either frames or three-dimensional digitizers is currently being used in neurosurgery or otoloaryngology. Those methods require the use of computed axial tomography (CT) or magnetic resonance imaging (MRI) prior to surgery. They also involve placing markers on the scalp prior to the imaging study of the head. The markers must be left in the same position until surgery is performed in order to confirm intraoperative registration. Such imaging studies are routinely performed for most intracranial procedures but are impractical for most orthopaedic procedures, especially those involving long bones. A probe marked with light emitting diodes (LEDs) or other digitizing emitters is used to localize these markers or pins using a three-dimensional digitizing device at the time of surgery. A disadvantage of this system is that the images are normally obtained hours before use; thus, the images used are not up to date (real time) and are often not reflective of the current condition of the object bone.  
         [0005]     Registration markers cannot be used on the outside of the body in most orthopaedic cases as the skin does not adhere to the underlying bone. Pre-operative registration for robotic placement of the femoral components for total hip arthroplasty requires the use of a separate procedure to insert screws for such markers. Such a separate procedure is highly impractical for routine orthopaedic procedures.  
         [0006]     An alternative method of registration for image guided surgery requires wide operative exposure, such as in pedicle screw insertion in spine surgery. The various fiducials are determined by touching prominent or distinctive anatomic points with a digitizing probe as employed by the stereotactic localization system. Furthermore, the system also requires preoperative computed axial tomography.  
         [0007]     A system using fluoroscopic images to guide the insertion of a fixation device employs tracking with a three-dimensional optical digitizer. This optical digitizer is used to determine the position in six degrees of freedom of a portable fluoroscopy machine (“C-arm fluoroscope”) and the object region of the skeleton. Light emitting diodes (“LEDs”) are placed in distinctive patterns on the C-arm. Another set of LEDs are attached to the bone with a percutaneous screw device, such as a reference bar. A computer program records these positions in relation to an optical position sensor.  
         [0008]     X-rays are then taken with the C-arm fluoroscope with the two positions of the tube at approximate right angles to one another. The optical position sensor can thus determine where the C-arm is positioned in relation to LED markers attached to the reference bar attached to the object section of the skeleton. The exact position is determined by using two-dimensional image registration, matching the outline of the bone in two planes. In this system, three or more distinctly shaped radiographic markers are attached to threaded tipped registration pins inserted percutaneously. Thus, the object portion of the skeleton is localized in six degrees of freedom by the optical digitizer.  
         [0009]     The computer program relates the position of the object bone with or without fiducial markers in the two fields to determine the exact relative position of the object bone seen on the two images. Once those two images are displayed on monitors, no further x-rays are needed. Thus, a substantial reduction in the amount of ionizing radiation results. The images displayed are those familiar to the surgeon but with the usual distortion eliminated.  
         [0010]     A drill with attached LEDs inserts the fixation device in the position in the bone that the surgeon chooses based on the supplied information. The three-dimensional optical digitizer determines the position of the drill in relation to the optical digitizer camera and the object section of the skeleton with its fiducials. A graphic display of the fixation device of predetermined length is then overlaid on the images of the object bone in near real time. Thus, the position of the inserted pin or drill bit can be adjusted immediately.  
       SUMMARY OF THE INVENTION  
       [0011]     The present invention allows an orthopaedic surgeon to safely determine the precise trajectory of insertion of a fixation device into an object bone and to check the accuracy of the procedure using real time feedback.  
         [0012]     The present invention remedies the disadvantages of the prior art system of using fluoroscopic images and an optical digitizer to localize the object bone and the track of the intended fixation device.  
         [0013]     The same three-dimensional optical digitizer is used to determine the position in six degrees of freedom of a portable fluoroscopy machine (C-arm fluoroscope) and the object regional of the skeleton. Light emitting diodes (LEDs) are placed in distinctive patterns on the C-arm and attached to the bone, the latter with a percutaneous screw device, such as a reference bar. A computer program records these positions in relation to an optical position sensor.  
         [0014]     X-rays are then taken with the C-arm fluoroscope with the two positions of the tube at approximate right angles to one another. The optical position sensor can thus determine where the C-arm is positioned in relation to LED markers attached to the reference bar attached to the object section of the skeleton. The exact position is determined by using two-dimensional image registration, matching the outline of the bone in two planes.  
         [0015]     The difference from prior art is that, in this invention, distinctly shaped radiographic markers are not required to match the position of the object bone with the image thereof. Matching, or registration, is performed by a single registration pin or other object that is seen on both x-ray views. The spherical shape of the femoral head may be used to increase the accuracy of the registration if the invention is used for hip surgery. When used for inserting distal locking screws for intramedullary nails, the presence of the nail alone with the holes for the interlocking screws can be used as fiducial reference marker. This method of image registration is clearly superior to the use of three special registration pins with specialized markers.  
         [0016]     The fixation device can then be inserted using a drill or drill guide that has attached LEDs that serve as means to localize it in six degrees of freedom. The graphic representation of the guide pin for a cannulated screw, drill bit, or extended projection of the drill guide positioned appropriately on the pair of monitors can be used to determine the correct trajectory.  
         [0017]     Accurate localization of a hip screw in the femoral head has been shown in an important clinical study to result in much superior results than if the screw is placed eccentrically. Accurate aiming of an interlocking screw in an intramedullary nail is difficult to obtain using all current techniques. It is improved by this invention such that operative time and radiation are markedly reduced.  
         [0018]     This invention has the advantage of simplifying the operation and making it more acceptable to use computer assisted surgery to improve accuracy. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0019]      FIG. 1  is an illustration of anterior and lateral x-ray views of the proximal femur with an intertrochanteric fracture with a hip screw in optimal position.  
         [0020]      FIGS. 2A &amp; 2B  are perspective illustrations of the intraoperative setting showing the C-arm fluoroscope, an optical digitizer camera, and the object body.  
         [0021]      FIG. 3  is an illustration of a drill with mounted light emitting diodes.  
         [0022]      FIG. 4  is an illustration of a pair of computer monitor screens with radiographic images of the object bone at positions approximately 90 degrees to one another, with a single registration pin and a reference bar in place, and with the graphic image of a guide pin  302  for a cannulated hip screw superimposed. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0023]     The operation for the internal fixation of intertrochanteric hip fracture  100  requires a guide pin for a cannulated hip screw, and subsequently cannulated screw  101 , to be placed into femoral head  102  from lateral cortex  103  of proximal femur  220  via femoral neck  104 , as illustrated in  FIG. 1 . Guide pin  302  for cannulated hip screw  101  determines the position of cannulated screw  101 . The ideal position of the guide pin for a cannulated hip screw, and thus screw  101 , is entirely within bone. The end of the pin, and screw  101 , is best positioned very near the subcortical bone but should not penetrate the cortex and thus enter the hip joint. The best results of an intertrochanteric fracture  100  must have been shown to occur when large screw  101  used is in the center of the femoral head at the subcortical bone. This position is normally obtained by placing the guide pin for a cannulated hip screw by estimation and by following its course on entry with repeated x-rays views in two planes. C-arm fluoroscope  200 , as seen in  FIG. 2 , must be moved from one position of the other. Repeated attempts may be needed before the optimal position of guide pin  302 , as seen in  FIG. 4 , for a cannulated hip screw can be obtained. Operating time and radiation exposure would be reduced by using image guided surgery. The accuracy and thus long term results would be improved.  
         [0024]     In this system of fluoroscopic image guided orthopaedic surgery with intraoperative registration, light emitting diodes (LEDs) are attached to portable C-arm fluoroscopy  200  at two sites. One LED  201  is placed to determine the position of C-arm  200  when in the upright position as in  FIG. 2A , which corresponds to the anteroposterior x-ray view when the patient  205  is supine. Another LED  202  is located so that it is seen by optical digitizer camera  212  when C-arm  200  is horizontal as in  FIG. 2B , corresponding to the lateral x-ray view.  
         [0025]     Patient  205  is lying supine in traction on a fracture table during the procedure. After appropriate sterile preparation, reference bar  210  with LEDs is inserted through a small incision into ilium  218 . The optical digitizer software is programmed to recognize the region of the skeleton attached to reference bar  210  as a rigid body. The rigid body computer model thus remains immobile, and the other objects with LEDs attached move in relation to this rigid body. Femur  220  must remain immobile in relation to ilium  218 , which is usually the case.  FIG. 4  illustrates x-ray views seen with the fluoroscope.  
         [0026]     Then proximal femur  220  is exposed through a routine lateral incision. Registration pin  215  is then inserted in proximal femur  220 . X-rays at approximate right angles are then taken in the standard anteroposterior and lateral views. When C-arm  200  is in the upright position ( FIG. 2A ), LEDs  201  facing optical digitizer camera  212  indicate to the computer where C-arm  200  is in three dimensional space. Thus the computer can calculate the plane in which body  205  lies—in relation to reference bar  210 . When C-arm  200  is in the horizontal position ( FIG. 2B ), LEDs  202  are now facing optical digitizer camera  212  and indicate again where C-arm  200  is in three dimensional space when in this position. The computer can then calculate exactly where body  205  and femur  220  seen on x-ray are in relation to optical digitizer camera  212 . This calculation is possible with registration pin  215  and femur  220  now being recorded in two positions. The method of finding the position of registration pin  215  is a type of image registration.  
         [0027]     LEDs  300  are mounted on the body of drill  301  as shown in  FIG. 3 . Guide pin  302  for cannulated hip screw  101  is placed in position into drill  301 .  
         [0028]     The signals emitted from LEDs  300  on drill  301  are received by optical digitizer camera  212  when placed in the operating field. The computer can then determine the position of drill  301  to reference bar  210  and thus to femur  220 . A graphic image of guide pin  302  for a cannulated hip screw can then be displayed on each monitor  400  as seen in  FIG. 4  to show the relationship of guide pin  302  for a cannulated hip screw to femur  220  in both the anteroposterior and the lateral views. Guide pin  302  for cannulated hip screw  101  can then be inserted in the desired position with image guidance.  
         [0029]     If reference bar  210  should be moved or loosened, registration can be done again during the operation just be repeating the two x-ray views. Once registration pin  215  is in place, identification of fiducials by the tedious method of touching points with a probe is unnecessary. The accuracy of image registration with registration pin  215  or other object is much greater than with previous methods.