Abstract:
A stereotactic device for localizing an MRI-imaged mass using horizontal and vertical protractors on which a laser is mounted. The protractors and laser are mounted on a table which may be positioned horizontally and vertically with respect to the patient table. The portion of the patient&#39;s body being imaged is fixed by a compression plate to which a reference target is mounted. The reference target incorporates a substance which is strongly imaged by the MRI. The compression plate comprises an array of relatively large apertures through which the radiologist may guide an instrument. From the MRI images, the radiologist takes an angle between the reference target and the suspect mass from each of two perpendicular planes and inputs these angles into the protractors of the stereotactic device. The table of the stereotactic device is adjusted horizontally or vertically with respect to the patient table so that the beam of the laser aligns with the reference target. The reference target is then removed from the compression plate so that the laser beam illuminates an entry point on the patient&#39;s body. The laser beam is thus aligned along a trajectory from the entry point to the suspect mass. The radiologist is then able to simply follow the laser beam with a biopsy needle or other instrument to make consistent arrival at the site of the suspect mass.

Description:
This application claims the benefit of U.S. Provisional Application No. 60/169,472, filed Dec. 7, 1999. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates to magnetic resonance imaging (MRI), and in particular, to a laser apparatus for guiding surgical procedures based on location information derived from such MRI imaging. 
     MRI is a technique for imaging structures within a patient&#39;s body. An atomic nucleus carries a charge and due to the intrinsic spin associated with the charged nucleus, each nucleus acts like a magnetic dipole. When an external magnetic field is applied to a patient&#39;s body, the nuclear dipoles are forced into orientation to the external field. An applied radio frequency pulse at a resonance frequency tilts the nuclei out of alignment. After the pulse passes, the nuclei relax and emit an electromagnetic signal that can be detected by antennas. The detected signal is then analyzed by a Fourier transform technique to yield an image of the internal structure of the patient&#39;s body. By manipulating the imposed external magnetic field and the applied radio frequency pulse, the image may be selected to be in a narrow plane. A sequence of such planes provides complete three dimensional information about the internal structure of the portion of the patient&#39;s body being imaged. Images may be taken in the coronal plane (the plane that divides the structure into front and back portions), the axial plane (the plane that divides the structure into left and right portions), and the sagittal plane (the plane that divides the structure into upper and lower portions). 
     If the images of the patient&#39;s body show a suspect mass, invasive surgical procedures including biopsy or ablation may be required. Localization of the suspect mass may be performed by the insertion of wires under the guidance of the MRI image. Various techniques are known for guiding an instrument to a suspect mass, e.g., mechanically aligned bores which guide the instrument from a selected entry point to the suspect mass. Such systems are called stereotactic, which means the use of vectors to position an instrument in three-dimensional space. 
     Such mechanical stereotactic systems are complicated and allow the surgeon little freedom in guiding the instrument. This is a severe limitation in that the skill of the surgeon is often required to precisely locate the suspect mass and insert the instrument into the mass. It is also desirable that a stereotactic system by constructed entirely of non-magnetic material, such as acrylic, aluminum or stainless steel since the system must operate within the fringes of the powerful MRI field. Finally, it is also desirable that a stereotactic system be lightweight, portable and adaptable to various types of MRI devices or to other types of imaging systems. Battery power, for example, would allow a stereotactic system to be independent of the power supply of the; imaging system. 
     The limitations of the prior art are overcome by the present invention as described below. 
     SUMMARY OF THE INVENTION 
     The present invention provides the radiologist performing biopsies and ablations of suspect masses localized by magnetic resonance imaging with a reference to guide needle or fiber insertion into the mass. The invention must be used within the fringe field of the MRI magnet and thus is non-magnetic to prevent the device from being torqued or drawn into the bore of the magnet. Part of the design criterion was that the invention be simple and inexpensive. The invention is able to be adapted to any type of patient table used for delivering a patient to the bore of a MRI magnet or other imaging device. The invention is battery operated and self contained, thus independent of any power requirements of the MRI system. 
     The stereotactic device of the present invention includes horizontal and vertical protractors on which a laser is mounted. The protractors and laser are mounted on a table which may be positioned horizontally and vertically with respect to the patient table. The portion of the patient&#39;s body being imaged, for example, a breast, is fixed by a compression plate to which a reference target is mounted. The reference target incorporates a substance which is strongly imaged by the MRI. The compression plate comprises an array of relatively large apertures through which the radiologist may guide an instrument. It is an important aspect of the present invention that the apertures are not narrow bores limiting the freedom of movement of the instrument. The apertures provide access but are not guides. 
     From the MRI images, the radiologist takes an angle between the reference target and the suspect mass from each of two perpendicular planes and inputs these angles into the protractors of the stereotactic device which is mounted on the side of the MRI patient table. The table of the stereotactic device is then adjusted horizontally or vertically with respect to the patient table so that the beam of the laser aligns with the reference target. The reference target is then removed from the compression plate so that the laser beam illuminates an entry point on the patient&#39;s body. The laser beam is thus aligned along a trajectory from the entry point to the suspect mass. The radiologist is then able to simply follow the laser beam with a biopsy needle or other instrument to make consistent arrival at the site of the suspect mass. The radiologist is able to target multiple pathways from the same entry site or multiple approaches to the target. 
     The stereotactic device of the present invention is independent of any particular MRI or other imaging system and thus no modifications to an existing system are required. It is desirable that the stereotactic invention be “portable” in the sense that it may be adapted to various types of imaging devices and in operation is independent of any particular imaging device. The invention may however be affixed in a permanent or semi-permanent fashion to a particular imaging device. 
     MRI images provide excellent localization of masses, but the information is not “real time.” Without a guidance system, the only way a radiologist can arrive at the suspect mass with needle insertion is through a hit-and-miss iterative process. The stereotactic device of the present invention provides guidance to the suspect mass and thus saves valuable time and multiple “sticks” to the patient, while allowing the radiologist freedom to adjust the trajectory of the instrument as necessary. 
     The present invention has been designed for breast biopsies and laser ablation in breasts, but is not so limited and could be used for other areas such as liver or kidney. 
     The design of presently available MRI coils and the patient table may limit the field of view of the invention. However, these limitations may be overcome by redesigning the coil and patient table. 
     It is therefore an object of the present invention to provide for a stereotactic system which provides the radiologist performing biopsies and ablations of suspect masses localized by magnetic resonance imaging with a reference to guide instrument insertion into the mass while allowing the radiologist freedom in guiding the instrument. 
     It is a further object of the present invention to provide for a stereotactic system which is non-magnetic and operable in the fringe field of an MRI magnet. 
     It is also an object of the present invention to provide for a stereotactic system which is able to be adapted to any type of patient table used for delivering a patient to the bore of a MRI magnet or other imaging device. 
     It is an additional object of the present invention to provide for a stereotactic system which is battery operated and self contained, thus independent of any power requirements of the MRI or other imaging system. 
     These and other objects and advantages of the present invention will be apparent from a consideration of the following detailed description of the preferred embodiments in conjunction with the appended drawings as described following. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a front elevation view of the present invention as installed on an MRI patient table. The patient table is shown with the end of the patient table in section imaging a breast in the axial plane. An alternate position of the present invention is shown in a partial view. 
     FIG. 2 is a partial enlarged view of the invention shown in FIG. 1 
     FIG. 3 is a partial top plan view of the breast imaging shown in FIG.  1 . The breast is being imaged in the sagittal plane. The partial view of the invention is shown in alternate positions. 
     FIG. 4 is a front elevation view of the present invention as installed on an MRI patient table (the patient table is in partial elevation view from the end of the patient table) illustrating an embodiment of the vertical slide. 
     FIG. 5 is a partial front elevation view of the vertical protractor. 
     FIG. 6 is a partial top plan view of the horizontal protractor. 
     FIG. 7 is a partial side elevation view of an embodiment of the present invention in which the center line of the laser pointer is in a plane which always contains the center line of the vertical pivot. 
     FIG. 8 is a front elevation view of the present invention as installed on an MRI patient table illustrating in alternate views the limits of vertical displacement of the protractors with respect to the imaged object. 
     FIG. 9 is similar to FIG. 2 showing schematically by horizontal arrows the movement of the compression plates. 
     FIG. 10 is a plan view of the reference target overlay plate. 
     FIG. 11 a  is a left elevation cross-sectional view of an alternative embodiment of a compression plate. 
     FIG. 11 b  is a left elevation cross-sectional view of a reference target overlay plate. 
     FIGS. 12 a, b,  and  c  are plan views of alternative embodiments of reference targets. 
     FIG. 13 a  is an end elevation view of an alternative vertical guide mechanism. 
     FIG. 13 b  is a partial perspective view of the alternative vertical guide mechanism of FIG. 13 a.    
     FIG. 14 a  is a plan view of an alternative embodiment of the stereotactic assembly. 
     FIG. 14 b  is a left side elevation view of an alternative embodiment of the stereotactic assembly. 
     FIG. 14 c  is a front elevation view of an alternative embodiment of the stereotactic assembly. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     With reference to FIGS. 1,  2  and  3 , the preferred embodiment of the present invention may be described. A patient is placed on the patient table  10 , which comprises a platform  11  axially movable in a horizontal plane. The patient table  10  may be provided with fold-down leaves  12 . 
     The preferred embodiment is described following with reference to the imaging of a breast, however, the present invention is not so limited and the following discussion is intended to be exemplary only. The present invention may be employed in the imaging and localization of other structures of a patient&#39;s body. 
     As shown in FIG. 1, the patient is placed on the patient table  10  in proximity to a breast coil  20  so that the breast  21  being imaged is fixed between two compression plates  22 ,  23 . The motion of the compression plates  22 ,  23  is shown in FIG.  9 . As will be described more fully hereinafter, the compression plate  23  is provided with a plurality of apertures. As shown in the partial enlarged view of FIG. 2, a reference target  30  is fixed in one of the apertures of the compression plate  23 . It is desirable that the reference target be capable of being plugged into the compression plate for a positive engagement without movement of the reference target. For example, a reference target overlay plate could include a plurality of plugs sized to positively engage a corresponding plurality of apertures on the compression plate. A material capable of being readily imaged would be incorporated into one of the plugs to provide the reference target. 
     The radiologist uses the MRI image to locate the suspect mass  31 . The reference target  30  is also seen on the MRI image. The reference target  30  is any material which is visible on the MRI image. For example, water molecules are selectively imaged by the MRI. Certain substances are well imaged, such as vitamin E (due to the oil content) or copper sulfate solution. 
     The MRI allows the radiologist to point to the suspect mass  31  and to the reference target  30 . The typical MRI instrument has the internal capability to calculate the horizontal angle A in the horizontal plane and the vertical angle B in the vertical plane from the reference target  30  to the suspect mass  31 . 
     As shown in FIG. 4, the stereotactic assembly  50  includes a hook  51  or other means to attach the stereotactic assembly  50  to the patient platform  11 . The patient platform  11  slides axially which allows horizontal adjustment of the position of the patient with respect to the stereotactic assembly  50 . In the preferred embodiment, the hook  51  fastens the stereotactic assembly  50  to the fold-down leaf  12 . The stereotactic assembly also comprises a fixed vertical member  54  which is rigidly affixed to the hook  51 . The stereotactic assembly  50  may be more rigidly affixed to the fold-down leaf  12  by a bolt  52  which.passes through the fixed vertical member  54  and the fold-down leaf  12  and bolts to a clamping plate  53 . 
     In the preferred embodiment, the stereotactic assembly  50  further comprises a vertical tube  55  attached to and spaced outwardly from the fixed vertical member  54 . A glide  56  is telescopingly mounted to the vertical tube  55  for vertical movement with respect to the fixed vertical member  54 . The stereotactic assembly  50  may also include means for fixing the glide  56  in various adjustable vertical positions with respect to the fixed vertical member  54 . The glide  56  is fixed to an adjustable vertical member  57 . A table  58  horizontally extends from the adjustable vertical member  57  and is supported by a table support bracket  59 . A protractor assembly  60 , described more fully below, is affixed to an outboard end  61  of the table  58 . 
     The protractor assembly  60  is carried on a vertical support member  62  attached to the outboard end  61  of the table  58 . The protractor assembly  60  comprises a battery powered laser  63  as shown in FIGS. 5 and 6 mounted to a horizontal protractor  64 . The battery operation is important in that it makes the device independent of the MRI power supply. This allows for portability and compatibility with any MRI or similar device. 
     The laser  63  is mounted such that the centerline of the horizontal protractor is aligned in a vertical plane with the centerline of the beam of the laser  63 . The horizontal protractor  64  is preferably of clear, non-magnetic material, such as acrylic. The horizontal protractor  64  is provided with etched graduations giving angles in the horizontal plane. The horizontal protractor  64  may also be provided with vernier controls to allow for fine adjustment of the angular position of the laser  63  and to positively fix the protractor in position. A simple form of vernier may be provided by a screw acting tangentially on the protractor against the force of a biasing means such as a spring or elastic band. The horizontal protractor  64  is also provided with a bubble level  65  to use in ensuring that the horizontal protractor  64  is level before use. The horizontal protractor  64  is mounted for rotation so that the laser  63  may be pointed to any selected angle in the horizontal plane. 
     The horizontal protractor  64  is mounted for rotation on a vertical protractor  66  such that the centerline of the laser  63  is passes through a horizontal plane that also includes the center pivot for the vertical protractor  66 . The vertical protractor  66  is preferably of a clear, non-magnetic material, such as acrylic. The vertical protractor  66  is provided with etched graduations giving angles in the vertical plane. A vernier adjustment means as described above may be provided for the vertical protractor also. The level  65  can also be used to ensure that the stereotactic assembly  50  is oriented vertically with respect to the patient&#39;s platform  11 . 
     One embodiment of the present invention is shown in FIG.  7 . The horizontal protractor  64  is mounted for rotation on a turntable support  80 . The turntable support  80  is affixed to a vertical protractor  66 . The vertical protractor  66  and turntable support  80  are affixed to a rod  81  in an offset fashion so that the centerline of the laser  63  is in the same horizontal plane as the center pivot of the vertical protractor  66 . The rod  81  is mounted for pivotal rotation on two vertical supports  62  which are attached to the table  58 . The rod  81  may be fixed in a particular orientation by a set screw  82 . This arrangement allows the orientation of the laser  64  to be fixed in the vertical plane. As an alternative, instead of moving the patient platform to point the laser  63  to the reference target  30 , the rod  81  may be moved horizontally with respect to the vertical supports  62 . 
     As noted above, the MRI allows the radiologist to point to the suspect mass  31  and to the reference target  30 . The MRI instrument then calculates the horizontal angle A in the horizontal plane and the vertical angle B in the vertical plane from the reference target  30  to the suspect mass  31 . In order to localize the suspect mass  31  and to provide the guidance trajectory for the radiologist, the angle A is first set on the horizontal protractor  64  so that the laser  63  is pointed at angle A in the horizontal plane. The patient platform  11  is then moved axially in the horizontal plane until the beam  70  of the laser  63  is pointed at the reference target  30 . 
     Then, with reference to FIG. 2, the angle B is set on the vertical protractor  66  so that the beam  70  of the laser  63  is pointed along the angle B in the vertical plane. The table  58  is then adjusted vertically by moving the glide  56  with respect to the vertical tube  55  until the beam  70  of the laser  63  is once again pointed to the reference target  30 . The beam  70  therefore establishes a trajectory from the reference target  30  to the suspect mass  31 . The maximum vertical motion of the stereotactic assembly  50  may be limited by the position of the breast coil  20  and the patient table  10  as shown in FIG.  8 . However, such limitations may be overcome by a redesign of the coil and table. 
     After established the trajectory of the guide beam  70 , the reference target  30  is then removed from the compression plate  23  so that an entry point on the breast is illuminated by the laser beam  70 . By aligning an instrument, such as a biopsy needle, with the laser beam  70 , the radiologist is able to guide the instrument from the entry point on the breast  21  to the suspect mass  31 . The radiologist is therefore able to see that the needle enters the patient properly yet still has full control of the needle so that the radiologist is able to adjust the motion of the needle as necessary. The insertion of the needle requires the radiologist to exercise tactile skill in locating and inserting the needle into the suspect mass. The radiologist must “feel” for the mass and often must twist the needle to properly insert it into the mass. Prior art stereotactic systems are mechanical in that the needle is inserted into a guide which limits the freedom of motion of the radiologist. 
     If a breast biopsy is being performed, compression plates  22 ,  23  are used to fix the breast  21  in position. A commonly-used compression plate is solid with angular edges. The compression plate  23  used with this invention has a number of arrayed apertures  71  as shown in FIG.  3 . The apertures  71  are large circular openings with beveled edges and the compression plate  23  has rolled-over edges and rounded edges for greater comfort for the patient. When the compression plates is compressed against the patient&#39;s skin, the tissue tends to slightly protrude through the apertures. By beveling the edge of the aperture, the compression plate tends to grip the protruding tissue and provides resistance to slippage of the patient&#39;s skin along the surface of the compression plate. In the preferred embodiment, it is desirable to bevel the edge of the aperture from both sides of the compression plate. It is an important aspect of this invention that the aperture be large enough to provide free access to the radiologist. The apertures  71  are not narrow bores for guiding an instrument, they are wide openings that provide free access and allow a wide range of motion to the radiologist in inserting an instrument into the entry point on the patient&#39;s body. 
     As discussed above, the reference target  30  is fixed in the compression plate  23  so as to provide a reference point. The compression plate  23  may also be modified to provide reference information directly on the MRI image. For example, reference numerals, such as coordinates in a three-dimensional coordinate system, may be formed in the compression plate  23  by routing the numeral into the acrylic material of the compression plate  23 . The routed areas are then filled with a material that images well, such as copper sulfate solution. The routed areas are then sealed, e.g., with a thin sheet of acrylic. When imaged the acrylic will not be visible on the MRI image, but the copper sulfated reference numerals will be visible. It may be desirable that the reference coordinates or numerals be removable from the compression plate, for example, to allowing for cleaning the compression. In an alternative embodiment, the reference numeral or coordinates may be formed into a separate overlay plate that can be plugged into the compression plate during imaging and removed for subsequent procedures. 
     The alternative embodiment of a reference target overlay plate is shown in FIG.  10 . Reference numerals or targets may be formed in the same manner as described above. The overlay plate  85  includes a plurality of reference targets  86  formed by drilling a series of target holes  91  partly through the overlay plate  85 . The target holes  91  are then filled with a material that images well, such as copper sulfate solution. The target holes  91  are then sealed, e.g., with a thin sheet  96  of acrylic. The embodiment of FIGS. 10,  11   a  and  11   b  show a series of reference targets  86  which align with corresponding apertures  89  in a compression plate  88 . Alignment of the overlay plate  85  with the compression plate  88  may be accomplished by any of a number of means known to those in the art. For example, one or more alignment posts  90  may be provided in the compression plate  88  to align with and connect with the alignment holes  87  in the overlay plate  85 . Means may also be provided for releasably connecting the alignment posts  90  to the alignment holes  87 . 
     In some embodiments of the compression plate  88  and the overlay plate  85 , the plates  88 ,  85  may be flat, but embodiments of the plates  88 ,  85  are contemplated in which the plates  88 ,  85  are shaped three-dimensionally to more accurately and comfortably conform to the portion of the body being imaged. In the embodiment of FIGS. 11 a  and  11   b,  the compression plate  88  is provided with a lower portion  92  which is angled with respect to an upper portion  93 . This configuration provides a better arrangement for imaging a breast. Desirably, the upper portion  93  is at an angle of approximately 40° to the lower portion  92 . The overlay plate  85  is correspondingy shaped to conform to the shape of the compression plate  88 . 
     In the embodiment of FIG. 10, the reference targets  86  are identified by letters or numerals to identify a particular aperture  89  in the compression plate  85 . Other forms of reference targets  86  are contemplated as being within the scope of the present invention. Examples of reference targets  86  are shown in FIGS. 12 a, b, c.  FIG. 12 a  shows a circulation configuration of target holes  91  with a central point  95 . FIG. 12 b  and show alternative arrangements with a linear group of target holes  91  to form a cross-shaped target. 
     A vertical adjustment mechanism for the stereotactic assembly  50  is described above with reference to FIG.  4 . An alternative mechanism may be described with reference to FIGS. 13 a  and  13   b  in which the vertical tube  55  and glide  56  are replaced with a first member  100  with an elongated dovetail  101  and a second member  103  with a dovetail shaped slot  104  in which the dovetail  101  is slidingly received. The vertical position of the first member  100  with respect to the second member  103  may be fixed with a set screw  105  which is threadedly received in a threaded hole  106  in the second member  103  so that the set screw  105  engages the dovetail  101 , thereby preventing the first member  100  from vertical movement with respect to the second member  103 . Either the first member  100  or the second member  103  may be attached to the fold down leaf  12  by means of the bolts  102 ,  107 , while the other set of bolts attaches to the stereotactic assembly  50 . 
     As described above with respect to FIG. 7, the horizontal position of the laser  63  may be set by moving a rod  81  with respect to vertical supports  62 . An alternative version is described with respect to FIGS. 14 a, b,  and  c  as follows in which the patient platform is moved to set the horizontal position of the laser  63 . In this embodiment, the horizontal protractor  64  is mounted for rotation on the turntable support  80 , which is in turn affixed to the vertical protractor  66 . The laser  63  is mounted on the horizontal protractor  64  so that the centerline of the laser  63  is in the same plane as the center of rotation of the vertical protractor  66 . A bubble level  65  is likewise mounted to the horizontal protractor  64 . The entire assembly comprising the vertical protractor  66 , the horizontal protractor  64  and the turntable support  80  is mounted for rotation between the arms  110 ,  112  of a yoke  111 . The yoke  111  is mounted to the table  58 . The turntable support  80  may be provided with a horizontal reference pointer  113  and the left arm  112  of the yoke  111  provided with a vertical reference pointer  114  for assisting in setting the horizontal angle on the horizontal protractor  64  and the vertical angle on the vertical protractor  66 , respectively. 
     The present invention must be constructed of non-magnetic material since it is located on the fringes on the very powerful MRI field. Suitable materials include stainless steel, aluminum or acrylic. 
     The present invention has been described with reference to certain preferred and alternative embodiments that are intended to be exemplary only and not limiting to the full scope of the present invention as set forth in the appended claims.