Abstract:
A system for rod bending for use in robotic spinal surgery, enabling the correct bending of a fusion rod to match the shape required to accurately pass through the heads of the pedicle screws. The system uses data generated by information provided to the robot by the surgeon&#39;s preoperative plan, optionally augmented by feedback from the robot control system of deviations encountered intraoperatively. Such deviations could occur, for example, when the surgeon decides intraoperatively on a different trajectory or even to skip screws on one vertebra, in which case, the robot will be commanded to perform the alternative procedure, with commensurate instructions relayed to the control system of the rod-bending machine. The system is also able to thin down the rod at predetermined locations along its length, adapted to be at selected intervertebral locations, for maintaining limited flexibility between vertebrae, instead of fixating them.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates to the field of the shaping of rods used for the fixation of vertebrae in spinal fusion treatment, and their use in robotically directed surgery, especially shaping performed using information obtained from pre-operatively generated images of the surgical site and intraoperative updates. 
       BACKGROUND OF THE INVENTION 
       [0002]    When performing surgery to insert vertebral fixation rods for spinal fusion, there is a need to ensure that the fusion rod is passed accurately between the tulips of the pedicle screws, before the screws are tightened onto the rod. This can be a problematic task since the spine may be severely deformed in a scoliotic patient, and even in a non-scoliotic patient, adjacent vertebrae generally have differing protrusion heights and are not linearly aligned because of the natural spinal lordosis. Reference is made to  FIG. 1  which illustrates such a typical vertebral fixation rod implementation, in which the rod  11  had been given a curvature to match the lordosis curvature of the spine  10 . In currently used procedures, the surgeon generally bends the fusion rod during the operation, typically using manual tools, so that it matches the positions of the tulips  12  of the pedicle screws, using his/her visual judgment in order to ensure that the rod fits accurately between the heads  12  of the various screws. However this procedure is prone to inaccuracies and since a typical fusion rod is intended to be a high strength component and is generally made of titanium or stainless steel and is typically 5 mm in diameter, the surgeon often has to exert considerable force using pliers to bend the rod appropriately during connection, in order to ensure that the rod fits without exerting undue pressure on the patient&#39;s vertebrae. 
         [0003]    In US Patent Application Publication No. 2005/0262911 to H. Dankowicz et al, for “Computer Aided Three-Dimensional Bending of Spinal Rod Implants, other Surgical Implants and other Articles, Systems for Three-Dimensional Shaping, and Apparatuses Therefore”, there is described a computer aided system for bending an implantable rod three-dimensionally, which is especially useful for pre-surgical formation of implantable spinal rods. Such a system may also use imaging performed intraoperatively on the surgical site, especially to determine the position of pedicle screw heads (tulips) to which the rod is to be attached, in order to determine the shape of the rod to be formed. However, in order to perform intra-operative bending of the rod to match the desired shape in 3D, this system requires the generation of additional images during the procedure, which subjects the patient and possible also the medical staff, to additional radiation exposure. 
         [0004]    Therefore, there is a need for an apparatus and procedure which will enable the surgeon to accurately and easily shape a vertebral fixation rod during the surgical procedure, without the need for additional imaging to determine the shape the rod has to be given. 
         [0005]    Additionally, although such rod assemblies may be used to fuse two adjacent vertebrae, there are often cases of scoliosis and severe deformities where the region of the spine to be treated may include even 10 or more vertebrae. Such a long construction may be used to rigidly connect all the vertebrae within the desired range, but in certain cases there is no need to fuse all the levels and some vertebra should not be fused together in order to preserve their relative motion. Hence there is also a need for a rod that poses different compliances at different points in accordance with the fusion or dynamic stability needs of the spine. 
         [0006]    There therefore exists a need for such devices and methods which overcomes at least some of the disadvantages of prior art systems and methods. 
         [0007]    The disclosures of each of the publications mentioned in this section and in other sections of the specification, are hereby incorporated by reference, each in its entirety. 
       SUMMARY 
       [0008]    The present disclosure describes new exemplary systems for rod bending for specific use in robotic spinal surgery, which enables the production on site in the operating room of a fusion rod correctly bent to match the shape required to accurately pass through the tulips on the heads of the pedicle screws, using data generated by the positional information provided to the robot by the surgeon&#39;s preoperative plan, augmented if necessary by data feedback provided by the robot control system of any deviations encountered intraoperatively in execution of the surgeon&#39;s preoperative plan. In a typical robotic spinal surgical procedure, the surgeon&#39;s preoperative plan is generally based on images of the patient&#39;s spine generated preoperatively, on the basis of which the surgeon plans exactly where the pedicle screws are to be inserted, at what orientation and to what depth. The surgical robotic system can then direct the robot in all three dimensions such that the drilling position and orientation is adapted to enable the screw hole to be drilled exactly in the position and orientation determined by the surgeon&#39;s preoperative plan. Furthermore the three-dimensional nature of the preoperative plan also enables the determination of the extent of protrusion of each screw in the AP direction relative to the patient&#39;s spine. In those robotic systems where the drilling itself is performed by a robotic tool, the feedback provided by the robot control system during the drilling operation can provide additional data regarding the extent of any deviation from the surgeon&#39;s preoperative plan. This could occur for example when the surgeon decides intraoperatively on a different trajectory or even to skip screws on one vertebra, in which case, the robot will be commanded to perform this alternative procedure, and these instructions will therefore also be relayed to the control system of the rod-bending machine. 
         [0009]    The data stored in the robotic control memory includes information regarding the exact position of the pedicle screw heads, both in the lateral and AP directions. This coordinate information can thus be used in a rod bending apparatus, using for instance controlled plungers, to deform the rod in the directions required, such that it matches the coordinate set required by the positions of the heads of the pedicle screws. The plungers can most conveniently be motorized, though other drive methods may also be used, and should be equipped with an encoding mechanism for defining their position. Alternatively, the information regarding the extent of bending required could be obtained by image processing of X-ray images obtained of the spine of the patient after the pedicle screws have been inserted. The output of this image processing procedure could be the set of coordinates in three dimensions through which the rod passes through. Alternative bending machine configurations can also be used. 
         [0010]    If the procedure is being performed using a navigation or a tracking system to define the position and orientation of the pedicle screw placements, an alternative source for the input data regarding the position of the pedicle screw heads could be provided by the navigation or tracking system itself. This data could be provided either by means of a touch probe which is directed onto the pedicle screw heads, or by means of position emitters fitted directly on the surgical tool or its tool guide. The control system of such a system is able to transfer the positional data directly to the control system of the rod bending equipment, to ensure that the desired shape of the rod is generated. 
         [0011]    Additionally, the rod bending apparatus could also be equipped with a facility for thinning down the rod at predetermined locations along its length, at which locations it is desired to maintain a level of flexibility between vertebrae, instead of fixating them. 
         [0012]    There is thus provided in accordance with an exemplary implementation of the devices described in this disclosure, a method for shaping an intervertebral connection rod for use in a computer assisted spinal stabilization procedure, the method comprising: 
         [0013]    (i) providing a surgical plan based on preoperative images of a patient&#39;s spine, the plan defining the position and orientation of pedicle screws whose insertion into the patient&#39;s vertebrae is to performed with the assistance of either a robotic system or a navigation system, 
         [0014]    (ii) generating from the robotic or navigation system, positional data incorporating the coordinates of the points at which the rod sits correctly in each desired pedicle screw head, 
         [0015]    (iii) inputting the positional data to the control system of a rod shaping system, the system adapted to use the positional data to bend a rod inserted therein, such that it adopts a shape that will sit correctly in the desired pedicle screw heads, and 
         [0016]    (iv) actuating the system to generate a correctly shaped rod for use in the spinal stabilization procedure. 
         [0017]    In such a method, the robotic system may be adapted to insert the pedicle screws, and the method may further comprise the step of adjusting the positional data according to any deviation from the preoperative surgical plan of the final position of the pedicle screw insertion, as determined by the robot system. 
         [0018]    According to a further implementation of the above described methods which use a navigation system, the navigation system is used to define the position of the pedicle screw heads by means of a touch probe. Alternatively, the navigation system may be used to define the position of the pedicle screw heads by means of reference markers either on the pedicle screw heads, or on a surgical tool adapted to drill a vertebral hole. 
         [0019]    In any of the above described methods, the rod-shaping system may comprise a plurality of plunger pistons disposed laterally to a cavity in which the rod is clamped, and wherein the positional data is used to move the plunger pistons such that they bend the rod to a shape in accordance with the positional data. Such a method may further compromise the rotation of the rod, such that the plurality of plunger pistons can shape the rod in three dimensions. Alternatively, the plurality of pistons may be arranged in more than one plane such that the rod can be shaped in three dimensions without being rotated in the cavity. 
         [0020]    According to yet another implementation of the above described methods, the rod shaping system may further comprise a rod thinning module, adapted to reduce the cross-sectional area of the rod at predetermined locations, such that the rod has increased flexibility at the predetermined locations. In such an implementation, the rod thinning module should be able to adapt the cross sectional dimension of the rod in different planes according to clinical need. In either of these cases, the rod thinning module may reduce the cross sectional dimension of the rod by means of indentations generated in the rod at the predetermined locations. In that method, the indentations may be generated by appropriately shaped plunger pistons. 
         [0021]    As an alternative to the use of plunger pistons, the rod thinning module may reduce the diameter of the rod by means of mechanical removal of material from the rod at the predetermined locations. That mechanical removal of material may be performed by a controlled milling action. 
         [0022]    Additionally, alternative implementations of methods for generating an intervertebral connection rod for use in a dynamic spinal stabilization procedure in a subject, may further involve: 
         [0023]    (i) providing a surgical plan of a patient&#39;s spine, the plan defining the desired shape of the intervertebral connection rod in three dimensions, and defining vertebrae between which dynamic mutual motion is to be maintained, 
         [0024]    (ii) using a rod shaping system to generate the intervertebral connection rod having the desired shape defined by the surgical plan, and 
         [0025]    (iii) using the rod-shaping system to reduce the cross-sectional area of the rod at rod locations corresponding to regions falling between the vertebrae when the rod is attached to the subject, such that the rod has increased flexibility at the regions. 
         [0026]    In such a method, the surgical plan may be based on preoperative images of the subject. 
         [0027]    Still other example implementations involve a system for generating an intervertebral connection rod for use in a dynamic spinal stabilization procedure in a subject, the system comprising: 
         [0028]    (i) clamps for holding the rod in the system, 
         [0029]    (ii) a bending mechanism for applying predetermined bends to the rod at preselected longitudinal and azimuthal positions such that the rod is shaped in accordance with a surgical plan, and 
         [0030]    (iii) at least one rod thinning element disposed such that the cross section of the rod can be reduced at predetermined locations along the length of the rod. 
         [0031]    In such a system, the bending mechanism may comprise a set of adjustable rod-bending elements, disposed in positions that enable the elements to apply predetermined bends to the rod at preselected longitudinal and azimuthal positions such that the rod is shaped in accordance with a surgical plan. Alternatively, the bending mechanism may comprise a rotatable chuck for gripping the rod, and a controlled bending mandrel adapted to apply a lateral force on the rod at a point distanced from the chuck. In any such systems, the surgical plan may be based on preoperative images of the subject. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0032]    The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which: 
           [0033]      FIG. 1  illustrates a typical vertebral fixation rod implementation, in which the rod had been given a curvature to match the lordosis curvature of the spine; 
           [0034]      FIG. 2A  illustrates schematically a plan view of a rod shaping apparatus, using mechanical plungers or pistons for bending the rod, and  FIG. 2B  shows a prior art press bending rod shaping apparatus; 
           [0035]      FIG. 3  illustrates how the robot control provides inputs to the plunger control of the rod shaping apparatus of  FIG. 2A , so that the rod is shaped to the desired form; and 
           [0036]      FIG. 4  illustrates a thinning operation being performed using the apparatus shown in  FIG. 2A  with a pair of oppositely disposed piston plungers. 
       
    
    
     DETAILED DESCRIPTION 
       [0037]    Reference is now made to  FIG. 2A , which illustrates schematically a plan view of a rod shaping apparatus  20 , using mechanical plungers or pistons  21  for shaping the rod. The rod  23  is firmly held in end clamps  22 , which may be rotatable to enable three-dimensional bent shapes to be executed. The plungers or pistons  21  may be driven by hydraulic or pneumatic cylinders, or by electric motors (none of which are shown in  FIG. 2A ), or by any other motion impartation device that can provide sufficient force to bend the rod as required. In the exemplary apparatus shown in  FIG. 2A , the rod-bending process in the plane shown is performed by sets of plungers or pistons, arranged opposite to each other, such that good control is achieved of the bending process, and the bending can be achieved in either direction of concavity. However, it is to be understood that a bend in any direction can also be achieved by having the plunger or piston oriented only at the intended concave side of the bend to be produced, and by applying force to the rod from that direction only. 
         [0038]    In order to achieve a three-dimensionally shaped rod, as will be required when the patient has any significant extent of scoliotic deformation to add to the natural lordosis curvature, the end clamps  22  may be constructed to be rotatable, and the bends applied in the appropriate plane by the plungers or pistons as the rod is rotated to each appropriate azimuthal angle. Alternatively, a static rod clamp may be used, in which case sets of plungers or pistons are disposed at different azimuthal angles about the axis of the rod, such that the three dimensional shape can be generated with the rod clamped statically. 
         [0039]    Reference is now made to  FIG. 2B , which illustrates schematically a plan view of another typical rod shaping apparatus, which may also be used in the implementation of the methods and systems of the present disclosure. Such a bending machine configurations have been known for a long time, and one such example is shown in the above referenced US patent Application Publication No. 2005/0262911. In  FIG. 2B , the rod  23  is held in a rotatable clamping chuck  24 , mounted on a sliding block base  26 , which can move the rod longitudinally along the linear machine base  25 . The bending process takes place by applying pressure, such as by means of a hydraulic cylinder  27 , to a push die  28 , which forces the tube  23  to bend around the forming die  29 , which has a radiused contact face to form a smooth curve. The position in the rod of the bend or bends is controlled by the longitudinal position of the sliding base block. Rotation of the rod in the rotatable chuck  24  enables a rod to be formed with three-dimensional curves. 
         [0040]    Reference is now made to  FIG. 3  which illustrates how the robot control provides inputs to the plunger control  33  of the rod shaping apparatus, so that the rod is shaped to the desired form. The surgical procedure of defining the position and orientation of the pedicle screws and their associated connection rods is generally performed by the surgeon in a surgical plan  30  generally obtained on the basis of preoperative three dimensional image sets, such as CT or MRI images of the region of interest. The surgical plan is used to define the robot pose to be adopted for the drilling of each pedicle screw hole. In some cases, the control system also supervises the drilling operation to form the hole and to screw in the pedicle screws to the required maximum torque to ensure firm insertion. The required information is extracted from the surgical plan  30  and is input to the robot control system  31 , to instruct the robot  32  to perform the desired motions to align the surgical tool as required for the process to be performed on the subject&#39;s vertebrae  39 , such as the drilling of holes for pedicle screws. In addition to providing instructions to activate the robotic motion, the robot controller  31 , or an additional control module for extracting co-ordinate information from the surgical plan, inputs location information to the rod shaping apparatus control module  33 . An information bus  37  conveys this information, advantageously in the form of a set of motions which each of the shaping pistons or plungers  34  must perform, to servo-controlled actuators  35  to move the plungers or pistons in order to bend the rod (not shown) clamped in the rod shaping apparatus  33  to the desired shape. In addition, in those implementations where the rod is also rotated to provide three-dimensional shaping, commands are also conveyed through the control bus  37  to the rod rotation servo motor or motors  36 . By this means, the rod shaping system is able to automatically produce a fixation rod, correctly bent to the shape required for use according to the initial surgical plan  30 , without the need for the surgeon to perform any manual operations on the rod during the surgery, in order to adapt it to match the exact positions of the pedicle screw heads. 
         [0041]      FIG. 3  shows the implementation of the methods of the present disclosure on a rod-shaping machine having plunger bending action, such as that of  FIG. 2A , but it is to be understood that these methods can also be applied to any other sort of controllable bending machine, such as that shown in  FIG. 2B , with the appropriate commands output from the shaping controller  33  being directed at the longitudinal motion drive, the bending die position actuator, and the rotational position of the clamping chuck. 
         [0042]    Furthermore, in installations where the robot also performs controlled insertion of the pedicle screws, a feedback signal from the robot defining the exact position into which each pedicle screw was inserted, can be used to input further information to the shaper controller, for providing any corrections needed to the bending profile, for instance, in the event that the physiological conditions of the bone were such that the pedicle screws were not inserted to the insertion level requested by the surgical plan, or in the event that the surgeon makes changes intraoperatively to the plan, as mentioned hereinabove. In addition, there is shown in  FIG. 3  an additional and alternative input  38  to the shaper controller from a navigation or a tracking system (not shown). 
         [0043]    The above description is applicable to situations where fusion is to be applied to all of the desired section of the patient&#39;s spine. However there are many situations in which, because parts of the spinal region being treated may clinically be preferred to have a level of natural flexibility, fusion is not required between all of the adjacent vertebrae of the patient&#39;s spine. However, instead of using separate sections of fusion rods excluding those vertebrae sections where fusion may not be required, it may be simpler and more advantageous to use a single rod (generally one on each side of the spine) in order to cover the entire section of the spine to be treated. Moreover, in order to achieve dynamic spinal stabilization between some vertebrae, some rigidity of the rod may be needed between those vertebrae, and this would be missing if two separate sections of rods were to be used. In such situations, some sections of the rod structure have to remain more flexible, such as in locations where the disc is still functional, while other sections of the rod have to maintain their stiffness to assist in providing complete fusion. In order to achieve this structure, at those locations of the patient&#39;s spine where some flexibility is desired, the rods can then be provided with thinned sections between the pedicle screw locations. The thinning of the rod can be achieved either by shaving or machining off some of the material of the rod in the region where increased flexibility is desired, or by using the same plungers to generate one or more dimples in the surface of the rod to reduce its thickness, and hence to increase its compliance, at that point. This can be achieved by actuating two opposing plungers operating against each other to thin the rod down in the space between the plungers. This thinning process may be applied either to a pair of rods on either side of the spine, or on a single rod positioned on one side of the spine. The latter procedure is often used in minimally invasive cases, where the use of one rod minimizes the number of skin incisions. Also, if a given compliance between non-fused vertebra is to be maintained in dynamic stabilization, then only one rod with variable rigidity may be preferable. 
         [0044]    Instead of plunger generated thinned segments, a miniature controlled milling cutter (not shown) can alternatively be applied to the rod at the relevant positions either to reduce the diameter of the rod, thus increase its flexibility in all orientations, or to generate an asymmetric radial dimension to increase flexibility in a predetermined radial direction, as now explained. 
         [0045]    The flexibility is generally applied isotropically, by thinning down the rod uniformly in essentially all azimuthal angles. However, there may be pathological situations in which flexibility is to be maintained in one particular plane of the spine, while rigidity is required another plane. This can be achieved by aligning the direction of the flexibility to match what is desired by the physiological situation of the patient&#39;s spine. This can be performed by changing the Moment of Inertia (MOI) of the rod in one plane relative to its orthogonal plane, by applying the thinned out section in one azimuthal plane relative to the rod&#39;s axis, but not in the other plane. The desired plane can be selected either by use of a rod shaping system having pistons or plungers aligned at a number of azimuthal angles around the rod and by applying the plungers appropriately, or by rotating the rod so that a single or a pair of oppositely located shaping plungers at a fixed azimuthal angle are aligned in the plane where the flexibility is to be applied. Alternatively, a miniature controlled milling cutter can be applied to the rod at the relevant positions and at the relevant azimuthal angles. 
         [0046]    Reference is now made to  FIG. 4  which illustrates one example of how such a thinning operation can be performed using the apparatus shown in  FIG. 2A . The exemplary implementation shown in  FIG. 4  uses a pair of oppositely disposed piston plungers  41  with mushroom shaped heads which generate indentations  42  on diametrically opposite points of the rod&#39;s surface. The indentations essentially thin the rod down. Alternatively, the above mentioned miniature milling cutter could equally well be used. In the case of classic die bending operations, such as in  FIG. 2B , the mechanical miniature milling cutter can be positioned at any suitable position along the longitudinal length of the machine. In all cases of thinning, care must be taken not to weaken the rod to a point at which there is danger that it will break due to material fatigue. 
         [0047]    Although the above described system has been described with reference to the generation of correctly bent fixation rods for use in spinal fusion using pedicle screw attachment, it is to be understood that the systems are not limited to this particular application, but can be used for bending and shaping orthopedic inserts where the shaping is performed intraoperatively, and where the shape is generally predefined by means of an image-generated preoperative surgical plan. 
         [0048]    It is appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and subcombinations of various features described hereinabove as well as variations and modifications thereto which would occur to a person of skill in the art upon reading the above description and which are not in the prior art.