Abstract:
A system and method for ameliorating spinal column anomalies, such as scoliosis, while accommodating growth of juvenile patients, includes pedicle screws and an extendable telescopic spinal rod of non-circular cross section.

Description:
CITATION TO PARENT APPLICATION 
       [0001]    This is a continuation-in-part application which respect to co-pending U.S. application Ser. No. 12/857,320, filed 16 Aug. 2010, from which priority is claimed. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates to methods and apparatus for management and correction of spinal deformities, such as scoliosis. 
         [0004]    2. Background Information 
         [0005]    A serious deficiency presently exists with respect to conventional treatment and instrumentation for treating spinal deviation anomalies (such as scoliosis). This is particularly true as it relates to juvenile (age 3-10) cases involving greater than 45° curvatures (as such terminology is understood in the field) and more particularly to idiopathic scoliosis. 
         [0006]    Currently, idiopathic scoliosis (“I.S.”) comprises approximately 75% of all juvenile cases. Those I.S. cases involving curvatures in the 25°-45° range indicate treatment through bracing (beginning roughly at the bottom end of this range), but become unbeatable by bracing (roughly at the top end of this range). Curvatures in excess of 45° indicate surgical intervention. 
         [0007]    Use of implanted spinal rod systems of the current art introduce significant patient risks. These include considerable likelihood of hardware dislodgement (such as when hooks are used to engage spinal rod system components), ulcerations of skin that overlies protrusions of implanted systems, premature fusion of adjacent vertebrae with highly deleterious growth and spinal contour issues, impairment of longitudinal spinal growth, worsening of axial plane deformities such as rib hump, aggravation of truncal balance problems, and greater chance of infections. 
         [0008]    To make matters worse, existing spinal rod systems, particularly when used in juveniles, require periodic lengthening and adjusting to accommodate growth (roughly every 6-9 months). For growing patients, especially juveniles, periodic lengthening and adjusting accommodates the change or increase in distance between spinal segments. Multiple surgical procedures may be required to adjust one or more components for lengthening and adjusting the spinal device. Further still, the existing systems only control curvature in two dimensions. Finally, a formal fusion procedure is required at or near skeletal maturity. 
         [0009]    An ideal system for addressing the present shortcomings of treatment options for juvenile scoliosis involving greater than 45° curvatures is one which (at least): (1) provides three-dimensional correction of spinal anomalies; (2) provides secure engagement between instrumentation of affected vertebrae; (3) obviates or diminishes the need for periodic lengthening procedures; and (4) obviates the need for formal fusions at skeletal maturity. 
         [0010]    Such a system would only be possible were it to “grow” with the patient (accommodate changes in distance in spinal segments or vertebrae), utilize other than easily dislodgeable skeletal engagement means, and maintain desired orientation and alignment of vertebrae in all dimensions. 
         [0011]    With respect to this latter objective: current spinal rods are of circular or round cross section. Were present spinal rods or attachment means to be left “loose” to accommodate longitudinal motions as vertebrae move relatively as a result of growth, there would be nothing to combat the deleterious axial rotation of the vertebrae (relative to the spinal rod) even as they are constrained in their longitudinal movement along the rod. Such axial rotation would result in far less than optimal correction of the overall spinal geometry, and potentially impair longitudinal growth of the spine. 
         [0012]    Were an ideal system for addressing juvenile scoliosis requiring surgical intervention to become available (addressing each of the above-listed shortcomings of the systems and methods of the present art), the recipients would benefit in at least the following ways: (1) they would enjoy a much higher incidence and degree of success in alleviating their spinal deformities (in all dimensions of spinal column geometry); (2) they would achieve more nearly normal growth expectations; (3) they would be spared from multiple surgical procedures with their associated risks and complications; (4) they would not face the painful and potentially catastrophic consequences of spinal rod system component dislodgement; and (5) they would maintain mobility at adulthood that would otherwise be lost though otherwise required fusions. 
       SUMMARY OF THE INVENTION 
       [0013]    In view of the foregoing, it is an object of certain embodiments of the present system to provide an improved system of spinal instrumentation for use in ameliorating aberrant spinal column deviation conditions, such as scoliosis, particularly (though not necessarily solely) in juvenile cases of idiopathic scoliosis. 
         [0014]    It is another object of certain embodiments of the present system to provide an improved system and associated method for ameliorating aberrant spinal column deviation conditions, such as scoliosis, which system and method addresses each of the above-listed shortcomings of the spinal rod systems and methods for addressing juvenile scoliosis that is of the present art. 
         [0015]    It is another object of certain embodiments of the present system to provide an improved system and associated method for ameliorating aberrant spinal column deviation conditions, such as scoliosis, which system and method reduce hazards to patients relating at least to implantation of instrumentation, subsequent post-implantation surgical interventions related to accommodation of patient growth, spontaneous vertebral fusions, and inhibition of normal growth of the spine. 
         [0016]    It is another object of certain embodiments of the present system to provide an improved method for ameliorating aberrant spinal column deviation conditions, such as scoliosis, which system accommodates growth without surgical intervention to the degree required of spinal rod systems of the present art. 
         [0017]    It is another object of the present system to provide an improved system of spinal instrumentation, and a method for the use thereof, for ameliorating aberrant spinal column deviation conditions, such as scoliosis, which system and method facilitate maintaining spinal correction in three dimensions, rather than the merely two dimensions presently achievable (to a limited degree, and with limited success) with systems and methods of the present technology. 
         [0018]    In satisfaction of each of the stated objects, as well as objects of natural extension thereof, embodiments of the inventor&#39;s present system provide improved systems and methods for use of such system which will afford its recipients with one or more of the following benefits: (1) a higher incidence and degree of success in alleviating spinal deformities (in more dimensions of spinal column geometry than are presently addressed); (2) achievement of more nearly normal growth expectations; (3) the avoidance of some of multiple surgical procedures, associated discomfort and risks otherwise required in association with presently available spinal rod systems; (4) the elimination of a substantial degree of risk of spinal rod system component dislodgement; and (5) the maintenance of mobility at adulthood to a degree otherwise be lost though otherwise required fusions. 
         [0019]    The spinal rod systems and the methods for use described herein, which are intended primarily to treat cases of juvenile scoliosis involving curvatures of greater than 45°, includes, in summary, adjustable length spinal rod, specifically an extendable telescopic spinal rod with means to slide or pass one end within another longitudinally, an anchor, for example a bone screw, more particularly a pedicle screw having a segment to be engaged to a bone or vertebra and a head segment to interface with the spinal rod, and a securing means configured for securing a mechanical engagement between the pedicle screw, for example, and the spinal rod for slidably engaging spinal rod[s] in a manner for both allowing passive, lengthwise adjustment while restraining axial rotation. 
         [0020]    With respect to the latter feature, one embodiment of the present invention involves spinal rods of non-circular cross section that are telescopically engaged with complimentarily configured collar or sleeve members. This configuration (shown elsewhere herein) accommodates longitudinal, patient growth-related extension of the overall implant, while maintaining corrective orientation in multiple dimensions. Because of the complimentary contours of the non-circular spinal rods and the extendable telescopic spinal rod, a “slide-only engagement” is achieved. That is to say: longitudinal movement of the vertebrae is allowed with growth modulation rod system engaged, while at the same time axial rotation and other undesirable movement of the instrumented vertebrae relative to the spinal rod is substantially, or nearly completely arrested. Therefore, once the spinal rod is itself contoured according to the desired spinal geometry, optimal scoliotic correction (in three dimensions) is achieved, not only at the time of initial implantation, but is perpetuated as the patient grows. Further or future spinal longitudinal growth is modulated by control in three dimensions. As used herein, reference to “extendable” is meant to be the common definition, for example lengthening, elongating, or stretching. Also, telescopic or telescoping is meant to be slide or pass one within another or lengthwise movement with one part entering another as the result of elongating or compressing or one part sliding alongside the other part, for example as a U-shaped rod resting within another U-shaped rod. 
         [0021]    Another embodiment of the present invention involves conventional, circular-in-cross-section spinal rods (usually two) that engage with telescoping collar, sleeve or bridge members to, once again, accommodate longitudinal, patient growth-related extension of the overall implant, while maintaining corrective orientation in multiple dimensions. In this latter case, axial rotation of the spinal rods relative to a collar, sleeve or bridge member is arrested, not by complimentary cross sectional geometry, but by fixed projections of various geometries that extend from the spinal rods through, and engage in a keyed fashion, with an elongate opening in the collar sleeve or bridge member(s). This configuration is also described and depicted elsewhere herein. 
         [0022]    Optimal methods for achieving the initial scoliotic correction in three dimensions, which the present invention will maintain for the growing (juvenile) patient are best illustrated through reference to U.S. Patent Application, Publication No. 20060195092, which Application (and resulting Patent, if any) is hereby incorporated by reference. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0023]    The present invention may be more easily understood with reference to figures, which are as follow: 
           [0024]      FIG. 1  is a diagrammatic, dorsal view of a spinal column with a growing spinal rod system of the present invention attached to selected vertebrae thereof. 
           [0025]      FIG. 2  is a perspective depiction of an example of a pedicle screw having the unique spinal rod engagement means of the present invention for preventing axial rotation of the pedicle screw (and associated vertebrae) relative to the spinal rod. 
           [0026]      FIG. 3  is a side elevational view of a spinal column having the preferred three pedicle screw “clusters” situated for engaging a spinal rod for the method of the present invention. 
           [0027]      FIG. 4   a  is a diagrammatic, perspective view of the extendable telescopic spinal rod of the present invention, shown engaged with pedicle screw anchors as a non-circular cross sectional spinal rod in the “slide-only engagement” as an unextended position, and  FIG. 4   b  as an elongated position, that is achievable, and is an object of the present growing rod spinal deviation correction system. 
           [0028]      FIGS. 5   a  and  5   b  are diagrammatic, perspective view of the extendable telescopic spinal rod of the present invention, shown in various geometries for axial plane control of the growing rod spinal deviation correction system. 
           [0029]      FIG. 6  is a side-by-side, elevational view of two spinal rod systems of the present invention (the latter-described embodiment), the system shown on the left in a shortened, pre-growth configuration, and the one on the right being shown in an expanded, post-growth configuration. 
           [0030]      FIGS. 7   a  and  7   b  an elevational side view of a second embodiment, spinal rod system of the present invention, respectively, before and after elongation. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0031]    With reference to  FIGS. 1-5   b,  the present growing rod spinal deviation correction system includes a number of pedicle screws  10 , each implanted in respective vertebrae  100  to which forces will be applied by way of a properly contoured spinal rod  30 , initially to achieve a scoliotic correction in an initial surgical intervention, and thereafter to maintain the desired correction, even as the patient grows. 
         [0032]    With particular reference to  FIGS. 4   a - 4   b  and  5   a - 5   b,  pedicle screws  10  and spinal rod  30  are respectively configured such that spinal rod  30  is an adjustable length spinal rod, specifically an extendable telescopic spinal rod with a means to slide or pass one end within another may, in a “slide-only engagement,” slide longitudinally with movement (longitudinal growth) of the vertebrae  100  (and associated pedicle screw  10 ), but the same are constrained from any axial rotation and other undesirable movement because of the respective geometry of the spinal rod  30 . and the portion of pedicle screws  10  with which the spinal rod  30  is mechanically linked (the “spinal rod engagement means”). 
         [0033]    The depicted embodiment of spinal rod  30  shown in  FIGS. 1 ,  3 ,  4   a ,  4   b  and  5   a  is of a substantially square cross sectional geometry and in  FIG. 5   b  of a triangular cross sectional geometry, and the associated spinal rod engagement means is configured in a complimentary fashion for both: (1) allowing longitudinal movement of the spinal rod  30  relative to pedicle screws  10  and (2) preventing axial rotation and other undesirable movement of the pedicle screw  10  relative to spinal rod  30 . However, it must be understood that other “non-circular” geometries for spinal rod  30  and the rod engagement means of pedicle screws  10  may be substituted for that shown herein as a preferred embodiment. For example cross sectional geometries (“non-circular geometries”) for spinal rods  30  may include (among others not listed) those which are triangular, hexagonal, rectangular, gear-toothed, cross-shaped, or ovoid, with the spinal rod engagement means portion of pedicle screws  10  being of a complimentary geometry. In each such case, by virtue of the relatively tight, nested engagement between a spinal rod  30  of non-circular cross sectional geometry with a spinal rod engagement means portion of pedicle screw(s)  10  of a complimentary geometry, substantially no axial rotation of pedicle screw  10  relative to spinal rod  30  is possible. 
         [0034]    The extendable telescopic spinal rod  30  and pedicle screw  10  of the growing rod spinal deviation correction system may be made from any strong material such as carbon fiber or metal for long term sustainability. Preferred materials for spinal rod  30  may be, for example, stainless steel, or titanium, or chromium or alloy thereof, more particularly cobalt chromium or cobalt chromium molybdenum or alloy thereof, or other material known to one of skill in the art. 
         [0035]    In the preferred embodiment of the pedicle screws  10  of the present invention, the head portion  12  of pedicle screws  10  is configured as a yoke-like structure for achieving a spinal rod engagement means, as depicted in  FIG. 2 . Two, upwardly projecting arms  16  cooperatively form this structure, defining a rod enclosure space  18 , itself having a lateral opening  20  through which a segment of spinal rod  30  may be laterally introduced into the rod enclosure space  18 . 
         [0036]    A screw-in plug, or “set screw”  22  serves to occlude opening  20  and thereby constrain the associated length of spinal rod  30  within space  18 . Set screw  22  is engaged in such a manner that it engages the adjacent surface of spinal rod  30  whereby substantially all relative movement between spinal rod  30  and pedicle screw  10  is arrested. 
         [0037]    Referring particularly to  FIGS. 1 and 3 , the preferred method for use of the present growing rod system involves, by way of an example involving a right thoracic curve, placing pedicle screws  10  in three clusters. An upper cluster  40  involves two pedicle screws  10  placed in vertebrae  100  above the upper end vertebrae (“UEV” in  FIG. 3 ) of the scoliotic curve; a middle cluster  42  placed in vertebrae  100  substantially at the apex of the scoliotic curve; and a lower cluster  44  placed in vertebrae  100  below the lower end vertebrae (“LEV” in  FIG. 3 ) of the scoliotic curve. Generally a second growth modulation system of identical construction is placed on the opposite side of the midline to add strength to augment correction and prevent implant dislodgement. In certain embodiments, the upper cluster  40  and lower cluster  44  may serve as counter-rotation anchor points when the middle cluster  42  anchors the principal curve straightening and vertebral derotation correction. 
         [0038]    Once spinal rod  30  is engaged with pedicle screws  10 , and the initial three-dimensional scoliotic correction is achieved, plugs or set screws are engaged with each of the pedicle screws  10 , and are tightened to “anchor” spinal rod  30 , while the extendable telescopic spinal rod allows the earlier-described longitudinal movement of the spinal rod with the vertebrae and associated pedicle screws  10 . Accordingly, as the spinal column grows or the distance in spinal segments increases, the extendable telescopic spinal rod elongates in the same plane relative to the longitudinal growth of the vertebrae and associated pedicle screws, providing for relatively uninhibited growth of the spinal segments. 
         [0039]    The extendable telescopic spinal rod  30  of the growth modulation rod spinal deviation correction system provides a large piston-cylinder sliding (extendable telescoping rod) smooth surface area interface, greatly improving the operability of the adjustable rod. The larger surface area interface for the extendable telescopic spinal rod  30  also reduces the chance for wear of the system parts, particularly metal wear and scoring that could lead to binding and possible metal debris and ion release. Metal wear and binding may occur in particular in other systems in which pedicle screws are engaged to slide longitudinally along a spinal rod. 
         [0040]    Once the present spinal rod system is implanted, as described, a juvenile patient&#39;s subsequent growth is unhindered by the system, while correction of the scoliotic curve is maintained to maturity and thereafter. Proper relative alignment of the vertebrae is maintained, as is the individual orientation of affected vertebrae, thereby achieving and maintaining a true three-dimensional scoliotic correction. Further or future spinal longitudinal growth is modulated by control in three dimensions. 
         [0041]    A second embodiment of the present invention of a growth-accommodating, three-dimensional correction spinal rod system is depicted in  FIGS. 6 ,  7   a  and  7   b . The spinal rod systems of the second embodiment are identified generally by the reference number  110 . 
         [0042]    Each system  110  includes at least two spinal rods  112 , one or more sleeve, collar or bridge members (hereafter “collar member”)  114 , and a central rod member  116 . The anticipated, optimal structure involves two collar members  114  that are rigidly attached respectively to each end of the central rod member  116 —held in-place by setscrews  118 . 
         [0043]    Each collar member  114  is attached at its medial end  121  to the central rod member  116 , and defines a channel  120  into which, on a lateral end  122  of collar  114 , a medial end  124  of a spinal rod  112  is telescopically received. 
         [0044]    Referring to  FIG. 8 . a projection  126  extends from the surface of each spinal rod  112 , extending through and slidably engaging a longitudinal slot  128  formed in each collar member  114 . This arrangement permits longitudinal movement of each spinal rod  112  relative to each collar member  114 , while resisting axial rotation of the spinal rod  112  relative to the collar  114 . This, in turn, has the effect if imparting corrective and axial rotational constraining forces on the subject spinal column to which system  110  is attached (by way of pedicle screws  130 ), as the rod, with respect to three dimensions as discussed above, will have been contoured to effect the desired spinal correction, leaving only elongation of the system  110  for accommodating growth as nearly the sole remaining free motion of relative system components. 
         [0045]    Regardless of the embodiment of the present invention that is chosen, constraint of relative movement of spinal rod systems of the present invention, excepting only longitudinal, over-all system length, achieves each of the objects stated above. Users can expect: (1) a higher incidence and degree of success in alleviating spinal deformities (in more dimensions of spinal column geometry than are presently addressed); (2) achievement of more nearly normal growth expectations; (3) the avoidance of some of multiple surgical procedures, associated discomfort and risks otherwise required in association with presently available spinal rod systems; (4) the elimination of a substantial degree of risk of spinal rod system component dislodgement; and (5) the maintenance of mobility at adulthood to a degree that would otherwise be lost through otherwise required fusions. 
         [0046]    Although the invention has been described with reference to specific embodiments, this description is not meant to be construed in a limited sense. Various modifications of the disclosed embodiments, as well as alternative embodiments of the inventions will become apparent to persons skilled in the art upon reference to the description of the invention. It is, therefore, contemplated that the appended claims will cover such modifications that fall within the scope of the invention.