Patent Document

CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of U.S. patent application Ser. No. 13/525,944, filed on Jun. 18, 2012 which claims the benefit of U.S. Provisional Patent Application Ser. No. 61/498,279 filed Jun. 17, 2011 and U.S. Provisional Patent Application Ser. No. 61/499,855 filed Jun. 22, 2011, all of which are incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to spinal surgery, such as spinal fixation, and more particularly relates to expandable spinal implants and flexible drivers for positioning and expanding the implants. 
       BACKGROUND INFORMATION 
       [0003]    Spinal implant surgery may be performed by a posterior lumbar interbody fusion (PLIF) approach, a transforaminal lumbar interbody fusion (TLIF) approach, or an extreme lateral interbody fusion (XLIF) approach. In these procedures, implants are inserted in desired positions in relation to the spine. Current spinal implant designs require an end approach deployment mechanism that is not satisfactory for certain procedures. For example, with scoliosis in the thoracolumbar spine, an orthogonal approach is often not possible. Additionally, with TLIF approaches utilizing expandable implants, the deployment has to be performed after the implant, e.g., cage or intervertebral spacer, has been turned inside the disk space. This prevents access to adjust the height of the implant after the implant has been turned, and makes extraction or removal problematic. 
         [0004]    Current expandable implant designs are limited to PLIF type of approaches because the implants cannot be turned or collapsed. However, with PLIF approaches, there may be a risk that the expanded implant or cage extrudes back into the nerves of the spinal canal along the direction of its original insertion. In contrast, when a spacer is inserted with a TLIF approach, it is turned such that the trajectory is along the wide axis (side-to-side) of the vertebral body and the implant cannot migrate out backwards into the spinal canal. 
       SUMMARY OF THE INVENTION 
       [0005]    The present invention provides expandable spinal implants and flexible drivers connected by a bendable joint that allow surgeons more flexibility when performing spinal surgeries. The connection between the driver and the implant includes a bendable joint, such as a helical high torque spring, that allows the implant and driver to move to different angular orientations with respect to each other, and to apply rotational force or torque from the driver to the implant and its expansion mechanism. During insertion of an implant into the desired position, the driver may be oriented in a direction different than the long axis of the implant. After the spinal implant is placed in the desired position, the driver is used to expand the implant in selected dimensions. In certain embodiments, the implants may include separate endplates which are connected by a mechanical connection which allows expansion or contraction. The endplates may be adjusted by the driver in parallel or oblique, or in kyphosis or lordosis, compared to the original configuration of the implant. 
         [0006]    An aspect of the present invention is to provide a surgical instrument comprising a driver, an expandable spinal implant, and a flexible connector connected to the driver and the implant, wherein the flexible connector is rotatable by the driver to expand the spinal implant. 
         [0007]    Another aspect of the present invention is to provide a surgical instrument comprising a driver having a proximal end and a distal end, and a flexible connector releasably attached to the distal end of the driver, wherein the flexible connector is structured and arranged to engage and expand a spinal implant when torque is applied to the flexible connector from the driver. 
         [0008]    A further aspect of the present invention is to provide an expandable spinal implant comprising upper and lower plates expandable away from each other, an expansion mechanism structured and arranged to move the upper and lower plates away from each other, and a flexible connector engageable with the expansion mechanism. 
         [0009]    Another aspect of the present invention is to provide a method of positioning and expanding a spinal implant in a patient. The method comprises grasping the implant with a driver in an aligned insertion orientation, positioning the implant in the patient at a desired position while rotating the implant from the aligned insertion orientation to an angled orientation, expanding the implant with the driver while the implant is in the angled orientation, and disengaging the driver from the implant. 
         [0010]    These and other aspects of the present invention will be more apparent from the following description. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]      FIG. 1  illustrates a TLIF spinal procedure in which an implant is initially inserted in one orientation, and then rotated into the desired position in relation to the spinal vertebrae. 
           [0012]      FIG. 2  is a partially schematic top view of an implant, driver and flexible connector, showing the arrangement of the components during an initial insertion stage, and also showing the arrangement of the components during a subsequent expansion stage (in phantom), in accordance with an embodiment of the invention. 
           [0013]      FIG. 3  is a partially schematic top view, and  FIGS. 4 and 5  are partially schematic side views, illustrating engagement between a driver and an expandable implant in accordance with an embodiment of the present invention. 
           [0014]      FIG. 6  is a partially schematic top view, and  FIG. 7  is an enlarged portion of  FIG. 6 , illustrating an intermediate stage of a TLIF spinal procedure utilizing an expandable implant, driver and flexible connector in accordance with an embodiment of the present invention. 
           [0015]      FIG. 8  is a partially schematic top view illustrating a TLIF spinal procedure in which an expandable implant has been placed in its final position and may be expanded using a driver and flexible connector in accordance with an embodiment of the present invention. 
           [0016]      FIG. 9  is a partially schematic side view of an expandable implant and flexible connector in accordance with an embodiment of the invention. 
           [0017]      FIG. 10  is a partially schematic side view of an expandable implant and flexible connector in accordance with another embodiment of the invention. 
           [0018]      FIG. 11  is a partially schematic side view of an expandable implant and flexible connector in accordance with a further embodiment of the invention. 
           [0019]      FIG. 12  is a partially schematic side view of an expandable implant and flexible connector in accordance with another embodiment of the invention. 
           [0020]      FIG. 13  is a partially schematic exploded end perspective view showing a release mechanism for disengaging a driver from a flexible connector in accordance with an embodiment of the invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0021]    The present invention provides apparatus and methods for surgical procedures in which an expandable implant is positioned and deployed in a patient by means of a driver and a flexible connector. The driver may be used to both position the implant in the desired location in relation to spinal vertebrae, and to expand the implant after it is positioned. The flexible connector transfers torque from the driver to thereby expand the implant, and is detachable from the driver or implant after the implant is expanded. 
         [0022]      FIG. 1  schematically illustrates a TLIF spinal procedure in which an expandable implant is initially inserted in one orientation, and then rotated into the desired position in relation to the spinal vertebrae. As shown in  FIG. 1 , a spinal vertebra  5  comprising a vertebral body  6 , transverse process  7 , spinous process  8  and spinal canal  9  is subject to a TLIF implant procedure. An implant generally labeled as element  10  is initially inserted between the transverse process  7  and spinous process  8 , while substantially avoiding the spinal canal  9 . During an initial insertion stage, the implant  10   a  is oriented as shown with its longitudinal or axial direction A corresponding to the initial direction of insertion I. Subsequently, the implant is moved to its final desired position, labeled as  10   b , in which the axial direction A of the implant  10   b  is aligned in a direction substantially transverse to the spinal vertebra  5 . The bottom face of the implant  10   b  may contact the anterior one-third of the vertebral body  6 , while the top face of the implant  10   b  contacts the vertebral end plates of an adjacent vertebra in the spine (not shown). As described above, the TLIF procedure illustrated in  FIG. 1  advantageously orients the implant  10   b  along a longer dimension of the vertebral body  6 , and in a direction that does not intersect the spinal canal  9 . 
         [0023]      FIG. 2  is a partially schematic illustration showing the initial arrangement of an implant  10   a , driver  20  and flexible connector  30  during an implant procedure, such as a TLIF spinal procedure, in accordance with an embodiment of the invention.  FIG. 2  also shows the arrangement of the implant  10   b , driver  20  and flexible connector  30  (in phantom) after the implant  10   b  has been positioned in its final location where the implant may be expanded. As shown in  FIG. 2 , the implant  10   a  is initially grasped by the driver  20 , which has a shaft  21  and a handle  22 . The driver  20  includes a stationary arm  23  and a pivoting arm  25 , as more fully described below. Although not shown in  FIG. 2 , an axially movable sleeve may be provided around the shaft  21  to force the pivoting arm  25  into the closed position (shown by the solid line) when the sleeve is extended away from the handle  22 , and to allow the pivoting arm  25  to move to the open position (shown in phantom) when the sleeve is retracted toward the handle  22 . 
         [0024]    As further shown in  FIG. 2 , the flexible connector  30  releasably couples the driver  20  to the implant  10   a ,  10   b . In the embodiment shown, the flexible connector  30  has a proximal end  31  connected to the driver  20  by means of a releasable engagement mechanism  27 . The flexible connector  30  also has a distal end  32  connected to the implant  10   a . As shown in phantom in  FIG. 2 , the implant may be moved to the position labeled as  10   b  while the pivoting arm  25  has been rotated away from engagement with the implant  10   b , and the flexible connector  30  bends but remains connected to the driver  20  and insert  10   b.    
         [0025]    In certain embodiments, the flexible connector  30  comprises a helical spring having sufficient flexibility to bend laterally, but sufficient torsional stiffness to transfer torque from the driver  20  to the implant  10  during the expansion operation. For example, the flexible connector  30  may comprise a double helical spring or a double start spring with two elements, one wound clockwise and one wound counterclockwise. Such a counterwound double helical arrangement may add torsional stability to prevent buckling or permanent deformation when the spring is tensioned with high forces. Examples of flexible helical couplings that may be adapted for use in accordance with the present invention include commercially available helical springs sold under the designation Heli-Cal by Helical Products Company, Inc. The flexible connector  30  may have any suitable dimensions, for example, a length of from 3 to 50 mm, and an outer diameter of from 1 to 10 mm. 
         [0026]      FIGS. 3-5  schematically illustrate an arrangement of an expandable implant  10  and a driver  20 . As shown in the top view of  FIG. 3 , the shaft  21  of the driver  20  has a distal end including a stationary arm  23  and a pivoting arm  25 . The stationary arm  23  includes a grip tooth  24  comprising an extended ridge having a generally V-shaped cross section. The pivoting arm  25  includes a similar grip tooth  26 . As shown in  FIG. 3 , each of the grip teeth  24  and  26  engage a grip recess  18  in the implant  10 , comprising a generally V-shaped groove running vertically from the top to bottom of the insert  10 . 
         [0027]      FIGS. 4 and 5  are side views schematically illustrating expansion of the implant  10 . The implant  10  includes an upper plate  11  and a lower plate  12  that may be expanded away from each other from a contracted position as shown in  FIG. 4  to an expanded position as shown in  FIG. 5 . For purposes of illustration, the pivoting arm  25  is not shown in  FIG. 4 or 5 . As most clearly shown in  FIG. 5 , as well as in  FIG. 3 , when the upper and lower plates  11  and  12  expand away from each other, the grip tooth  24  on the stationary arm  23  may remain engaged with the respective grooves  18  in the upper and lower plates  11  and  12 . In this manner, the stationary arm  23  of the driver  20  may remain engaged with the implant  10  not only during placement of the implant  10  in the desired location within the spine, but also during subsequent expansion of the implant  10 . 
         [0028]      FIGS. 6 and 7  schematically illustrate an intermediate stage of a TLIF spinal procedure in which the implant  10  has been inserted into the region of the anterior one-third of the vertebral body  6 , and is being rotated toward its final transverse position. The trajectory of the implant  10  starts approximately parallel to the direction of the two adjacent spinal pedicles on the ipsilateral side of the spine. As the spinal implant  10  is rotated it is turned by the implant driver  20  into a position such that the long axis of the implant is in the translateral or transverse axis. As shown most clearly in the enlarged view of  FIG. 7 , the stationary arm  23  and its grip tooth  24  may remain engaged in the respective grip recesses  18  of the implant. However, the pivoting arm  25  has been rotated to a position as shown in which its grip tooth  26  has disengaged from its corresponding grip recesses  18  in the insert  10 . Although the grip tooth  26  of the pivoting arm  25  has been disengaged, contact may still be maintained between an inner surface of the pivoting arm  25  and an end corner of the implant  10 . As further shown in  FIG. 7 , at this stage of the procedure, the flexible connector  30  bends but is still secured to both the driver  20  and implant  10 . In certain embodiments, the flexible connector  30  may also expand or contract along its longitudinal axis, e.g., the connector  30  may comprise a helical spring that extends and/or compresses during stages of the procedure. 
         [0029]      FIG. 8  illustrates a subsequent stage of a TLIF spinal procedure in which the implant  10   b  is located at its desired transverse position in relation to the anterior one-third of the vertebral body  6 . The long axis of the implant  10   b  is in the transverse orientation, i.e., the line bisected by the anatomic transverse and coronal planes. In this position, the grip tooth  24  of the stationary arm  23  may still remain in contact with the corresponding grip recesses  18  of the implant  10   b , however, the pivoting arm  25  may no longer contact the implant  10   b . During the stages shown in  FIGS. 6-8 , the stationary arm  23  may be used in various ways to push or otherwise force the implant into position. For example, instead of maintaining contact between the grip tooth  24  and the grip recesses  18  during the entire procedure, the arm  23  may be manipulated by the surgeon in any desired manner to contact various parts of the implant  10  with various parts of the arm  23  to move the implant into the desired position. 
         [0030]    After the implant  10   b  has been moved into position as shown in  FIG. 8 , torque may be applied to the driver  20  to rotate the flexible connector  30  in order to expand the implant  10   b , as more fully described below. After the expansion step is completed, the driver  20  is disengaged from the implant  10   b . In one embodiment, the driver  20  is disengaged by releasing the flexible connector  30  from the driver  20 . In another embodiment, the driver  20  is disengaged by disengaging the flexible connector  30  from the implant  10   b.    
         [0031]      FIGS. 9-12  schematically illustrate embodiments of expandable implants  10  in accordance with the present invention. In the embodiment shown in  FIG. 9 , the implant  10  includes upper and lower plates  11  and  12  comprising angled expansion ramps  13  on their inwardly facing surfaces. A threaded expansion rod  14  extends along the longitudinal axis of the implant  10  in the region between the upper and lower plates  11  and  12 . Internally threaded expansion wedges  15  are threaded onto the expansion rod  14 . The threaded expansion rod  14  may be rotated around its longitudinal axis by turning the flexible connector  30 . Rotation of the flexible connector  30 , and the resultant rotation of the threaded expansion rod  14 , causes the internally threaded expansion wedges  15  to move axially along the rod  14  with their upper and lower exterior surfaces sliding along the expansion ramps  13 . When the wedges  15  move toward each other, the upper and lower plates  11  and  12  expand away from each other. While the expansion wedges  15  may be have cross-sectional shapes that are circular or otherwise rounded, in a preferred embodiment, the expansion wedges  15  have square or rectangular cross sections that prevent the wedges from rotating around their central longitudinal axes. In this embodiment, the expansion ramps  13  may comprise substantially flat surfaces contacting correspondingly flat surfaces of the expansion wedges  15 . 
         [0032]    In the embodiment shown in  FIG. 10 , the upper and lower plates  11  and  12  of the implant  10  have a similar configuration as shown in the embodiment of  FIG. 9 . However, the implant  10  has generally conical expansion wedges  17  that are externally threaded, and an expansion rod  16  is not threaded. In this embodiment, the expansion ramps  13  are preferably concave with conical surfaces that contact the threads of the conical externally threaded wedges  17 . In this embodiment, the cross-sectional shape of the expansion rod  16  may be non-circular, and the externally threaded wedges  17  may have correspondingly shaped holes extending axially therethrough with sufficient clearance for the wedges  17  to axially slide along the expansion rod  16 . In this manner, the externally threaded wedges  17  may be free to slide along the axial length of the expansion rod  16 , but are constrained to rotate with the expansion rod  16  when the expansion rod  16  is rotated around its longitudinal axis. Rotation of the flexible connector  30  causes the expansion rod  16  and externally threaded wedges  17  to rotate around their longitudinal axes, while the wedges  17  are free to slide along the axial length of the expansion rod  16 . Contact between the external threads of the wedges  17  and the conically shaped inner surfaces of the expansion ramps  13  causes the wedges  17  to move axially toward each other, which results in expansion of the upper and lower plates  11  and  12  away from each other. 
         [0033]    The embodiment shown in  FIG. 11  is similar to the embodiment shown in  FIG. 9 , except the expansion ramps  13   a  of the upper and lower plates  11  and  12  are oriented in opposite directions, and the wedges  15   a  are likewise oriented differently. In this embodiment, rotation of the flexible connector  30  causes the wedges  15   a  to move away from each other along the longitudinal axis of the threaded expansion rod  14 . As the wedges  15   a  move away from each other, their exterior surfaces slide against the interior surfaces of the expansion ramps  13   a , thereby forcing the upper and lower plates  11  and  12  away from each other. 
         [0034]    As shown in  FIGS. 9-11 , the distal end  32  of the flexible connector  30  is attached to one end of the expansion rod  14  or  16 . It is noted that in the embodiments shown in  FIGS. 9-11 , the flexible connector  30  is illustrated as bending in a downward direction, however, it is to be understood that the flexible connector  30  may also bend in other directions, for example, into the page and/or out of the page in  FIGS. 9-11 . In the embodiments shown, the distal end  32  of the flexible connector  30  includes a hexagonal recess  34  configured to receive the head of a releasable engagement mechanism  27  of the driver  20 , as more fully described below. In the embodiment shown, the distal end  32  of the flexible connector  30  may be permanently secured to the end of the expansion rod  14  or  16 , while the proximal end  31  of the flexible connector  30  may be releasably engaged with the driver  20 . Alternatively, the distal end  32  may be releasably engaged with the expansion rod  14  or  16 , while the proximal end  31  may remain engaged with the driver  20 . For example, the distal end  32  of the flexible connector  30  may have a hex-head projection or recess that matingly engages a corresponding hex-head recess or projection at the end of the expansion rod  14  or  16 . Such a hex-head connection may be sufficiently tight such that the connection is maintained during the steps of inserting, positioning, and expanding the implant, but may be disengaged after the implant is expanded by pulling the driver back with sufficient force remove the hex-head projection from the recess. 
         [0035]      FIG. 12  schematically illustrates another embodiment of an expandable implant  10  in which the upper and lower plates  11  and  12  are expanded away from each other by means of a distractor paddle  116  having an outer cam surface that contacts inner surfaces of the upper and lower plates  11  and  12  and forces them away from each other when the paddle  116  is rotated around its longitudinal axis. The upper and lower plates  11  and  12  include expansion ramps  113  having surfaces that engage expansion wedges  15   a  and  15   b . During the expansion procedure, the distractor paddle  116  is rotated to spread the upper and lower plates  11  and  12  away from each other, then a pusher  118  is used to move the first expansion wedge  115   a  into a desired axial location where contact between the outer surface of the expansion wedge  115   a  and the expansion ramps  113  results in the desired amount of expansion of the upper and lower plates  11  and  12 . Next, the distractor paddle  116  may be rotated by the paddle shaft  117  to a position in which there is sufficient clearance between the distractor paddle  116  and the inner surfaces of the upper and lower plates  11  and  12  to allow the distractor paddle  116  to be at least partially removed from the region between the upper and lower plates  11  and  12 . The paddle shaft  117  is thus used to rotate and axially move the distractor paddle  116 . Upon removal of the distractor paddle  116 , the interior space between the upper and lower plates  11  and  12  may be packed with bone material or the like in order to facilitate fusion of the implant  10  into the spinal structure. After the interior space is packed with material, the second expansion wedge  115   b  may be moved into a desired axial position by inserting it through the proximal end of the implant  10 . The wedge  115   b  may be placed with a screwdriver or other tool (not shown) which rotates the wedge  115   b  90 degrees after it is inserted deep into the proximal end of the central cavity of the implant  10 . The proximal wedge  115   b  may have an oblong or elliptical cross-sectional shape. The proximal wedge  115   b  may be inserted past the proximal ramp steps or teeth, and then rotated  90  degrees such that its largest dimension of the ellipse is from cephalad to caudad. The proximal wedge  115   b  may then be pulled toward the ipsilateral open end of the implant until the smallest ramp is engaged or tight. The proximal wedge  115   b  may thus be pulled away from the other wedge  115   a , and then rotated around its longitudinal axis to contact the expansion ramps  113  of the upper and lower plates  11  and  12 . The expansion wedges  115   a  and  115   b  may have non-circular cross sections which facilitate placement of the wedges in their desired axial locations, and retention in those positions in contact with the expansion ramps  113 . 
         [0036]    The dimensions used for the various components of the expandable implants  10  may be selected as desired. For example, a typical implant  10  may expand 10 percent to 100 percent of its original compact height, e.g., an implant may have a compact height of 8 mm and an expanded height of 12 mm. Any suitable length of implant may be used, for example, from 10 to 80 mm, e.g., 50 mm. 
         [0037]    In the embodiments shown in  FIGS. 9-12 , the expansion ramps  13 ,  13   a  and  113  may be sized and arranged as desired. For example, each expansion ramp  13 ,  13   a ,  113  may have a dimension of 1 mm high and 1 mm in width, with a 10 to 15 degree ramp angle. In certain embodiments, the ramps may be used to incrementally raise the height of an implant, e.g., from 8 mm to 9 mm to 10 mm to 11 mm to 12 mm in succession. The upper and lower plates  11  and  12  of the implants  10  may have openings of suitable sizes that allow bony ingrowth through the fusion cage, e.g., approximately 5 mm by 20 mm in size. 
         [0038]    The wedges, rods and other components of the expansion mechanisms may be made of any suitable material such as titanium, while the upper and lower prosthetic endplates  11  and  12  may be made of poly-ether-ether-ketone (PEEK) or other suitable materials. The components of the driver  20  and flexible coupling  30  may be made of suitable materials such as stainless steel, titanium, and the like. 
         [0039]    In certain embodiments, the expandable implants may be manufactured of known radiolucent material to allow radiographic visualization of the bone graft healing and incorporation. The flexible driver allows the surgeon to reference the radiolucent implant orientation via a more constrained and predictable junction. A more secure linkage makes it easier to exchange preparation instruments, soft tissue protective cannulas, trochars, particularly while inserting implants over guidewires. 
         [0040]      FIG. 13  schematically illustrates a release mechanism  27  for engaging and disengaging the driver  20  from the flexible connector  30 . It is noted that the various components are not drawn to scale in  FIG. 13 , but are provided for illustration purposes. In the embodiment shown, the release mechanism  27  comprises a hex-head connector including radially movable engagement members or jaws  28 . The outer surfaces of the jaws  28  are configured to engage respective inner surfaces of the hex head recess  34  of the flexible connector  30 . When the jaws  28  are inserted into the recess  34  and forced radially away from each other, they engage and are secured in the recess  34 . An axially movable rod plunger  29  is used to force the jaws  28  radially away from each other by insertion of its tapered head into opposing semi-circular channels in the interior surfaces of the jaws  28 . The rod plunger  29  is axially movable inside the cannulated driver shaft  21 . Although not shown in  FIG. 13 , the jaws  28  may be biased radially towards each other, for example, through the use of tension springs (not shown). Thus, when the rod plunger  29  is retracted along its longitudinal axis away from the jaws  28 , the jaws  28  collapse toward each other, thereby disengaging their outer surfaces from the recess  34  of the flexible connector  30 . 
         [0041]    Although not shown in  FIG. 13 , the rod plunger  29  can also be threaded to create a smoother insertion without a need for hammering or impaction force. Although a hex-head connection using two radially movable jaws is shown in  FIG. 13 , it is to be understood that any other suitable type of releasable coupling may be used in accordance with the present invention. For example, instead of two jaws  28  as shown in  FIG. 13 , three, four, five, six, or more radially expandable jaws or pivot arms may be used. Furthermore, although a hexagonal recess  34  is shown in  FIG. 13 , any other suitable recess configuration could be used, such as square, rectangular, triangular, oval and the like. Although the driver  20  is releasably attached to the flexible connector  30  in the embodiment shown in  FIG. 13 , the flexible connector  30  may alternatively be releasably attached to the implant, e.g., by a coupling similar to that shown in  FIG. 13  with a flexible rod plunger extending through a cannulated central opening through the flexible connector  30 , a tight-fitting hex head connection that can be disengaged after the implant is expanded by pulling the driver and flexible connector away from the expanded implant with sufficient force, or the like. 
         [0042]    The instruments of the present invention allow an implant to be optimally positioned before it is expanded. For example, a TLIF implant can be placed at an angle of up to 90 degrees from the posterior angle of insertion. Such a procedure allows a minimally invasive approach, as the incision and exposure do not have to be extended to allow manipulating or turning the expandable implant. This allows moving a TLIF implant into the preferred direct transverse orientation before opening. 
         [0043]    In certain embodiments, the invention allows for expansion of an expandable XLIF implant with minimally invasive exposure. Often with a deformity, or with multiple procedures performed through the same small incision, the orientation of the interbody fusion changes as the deformity is reduced. The angle of performance of the XLIF and the disk space changes by the end of the case. This is common especially when dealing with L4-L5 and especially when dealing with the reduction of a scoliotic deformity. The flexible driver of the present invention allows for fine tuning, readjustment, backing off, re-expansion and balancing the expansion between the multiple XLIF implants at the end of the procedure. 
         [0044]    The flexible driver of the present invention may be used in other types of minimally invasive spine surgery. In such MIS procedures, the approach is through a tube, narrow corridor, or confined space. This puts a premium on screwing, drilling, tapping, cutting screw threads, and performance of other maneuvers through a confined corridor without the ability to alter the angle of trajectory of the tool shaft. The flexible driver of the present invention helps solve this mechanical challenge by applying a rotational force at an angle from the insertion direction. 
         [0045]    In certain embodiments, anchorage of a stand alone anterior lumbar interbody fusion (STALIF) type cages or interbody spacers is facilitated by an angled driver with a helical spring flexible component. This is particularly useful as the implant surgery becomes more minimally invasive. 
         [0046]    In certain types of procedures, two expandable implants may be positioned side by side in the intervertebral disk space. If the expandable implant that is anterior is expanded and the posterior expandable implant is collapsed then this would increase and adjust the amount of spinal lordosis. On the contrary, if the reverse occurs with the anterior implant collapsing and the posterior implant expanding then this would increase the amount of kyphosis. 
         [0047]    In certain other types of procedures, two expandable implants may be placed laterally end-to-end and individually adjusted. The expandable implants could adjust the amount of coronal balance, and scoliosis correction could be adjusted after implant insertion at multiple levels but before closing the skin. By adjusting and expanding the implants differentially, the spine can tilt left or right. Thus, the functional spinal unit can be used to correct scoliosis apex toward the left or the right. The functional spinal units with expandable implants may be stacked one above another such as from T12 to L3 in order to correct a thoracolumbar scoliosis. 
         [0048]    Whereas particular embodiments of this invention have been described above for purposes of illustration, it will be evident to those skilled in the art that numerous variations of the details of the present invention may be made without departing from the invention as defined in the appended claims.

Technology Category: 1