Abstract:
The instant invention is a longitudinally adjustable corpectomy device which fits within the intervertebral distracted channel. A ratchet mechanism allows for an extendable member to adjust to a longer length to accommodate a distracted channel. The ratchet type mechanism allows the members to move in a unidirectional movement to prevent the two members from contracting once expanded.

Description:
PRIORITY CLAIM 
       [0001]    In accordance with 37 C.F.R. 1.76, a claim of priority is included in an Application Data Sheet filed concurrently herewith. Accordingly, the present invention claims priority as a continuation-in-part of U.S. patent application Ser. No. 14/214,397, entitled “EXPANDABLE CORPECTOMY DEVICE”, filed Mar. 14, 2014 and issued on December 15, 2015 as U.S. Pat. No. 9,211,197, which claims priority to U.S. provisional patent application Ser. No. 61/785,423, filed on Mar. 14, 2013, entitled “EXPANDABLE CORPECTOMY DEVICE”, the contents of which are hereby expressly incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The invention generally relates to improvements to vertebral implants and, more particularly, to a longitudinally expandable vertebral implant including telescoping sections configured for incremental expansion by a ratchet expander for ease of securement at any desired increment in situ. 
       BACKGROUND OF THE INVENTION 
       [0003]    The spine consists of vertebrae that are categorized into sections known as the cervical, thoracic and lumbar section in a flexible arranged column. The vertebrae are separated by small cartilaginous cushions known as intervertebral discs. Intervertebral discs are oblate spherical structures that maintain the space between adjacent vertebrae. Each intervertebral disc consists of an outer annulus fibrosus, which surrounds the inner nucleus pulposus. The annulus fibrosus consists of several layers of strong annular fibrocartilage to contain the nucleus pulposus and distribute pressure evenly across the disc wherein a mucoprotein gel serves to absorb shocks. 
         [0004]    Deterioration of an intervertebral disc results in limited mobility and can cause severe pain. For instance, normal aging causes the nucleus pulposus to lose fluid and contract in volume resulting in a reduction in the intervertebral space. Any reduction of space between adjacent vertebrae may put pressure on the nerves of the spinal column. Further, a reduction in volume of the nucleus pulposus reduces the disc&#39;s ability to absorb shock which can result in disc herniation. The bulge of a herniated disc may also put pressure on nearby nerve structures resulting in pain as well as diminished range of motion. 
         [0005]    Surgical options are available including laminectomy and discectomy combined with vertebral fusion and/or dynamic stabilization. However, these surgical options are highly invasive and require prolonged hospitalization. and recovery. More recently, artificial disc replacement prosthetics have been used to replace or augment all or part of the removed or resected intervertebral disc. 
         [0006]    In order to reduce the pain associated with the movement of the intervertebral joint, surgical intervention is often indicated as a means to alleviate pressure upon the spinal cord while concomitantly stabilizing the associated. vertebrae. This involves a surgical procedure to distract the disc and or vertebra, or portions thereof, and the insertion of bone fusing material into the cavity of the opposing vertebra. Corpectomy devices have been developed to support the spine and maintain the normal spacing between opposing vertebrae. Some of these devices may be packed. with fusing material to ensure solid bone growth between the two vertebrae. Typically, corpectomy devices are manufactured at various heights requiring that a cavity between opposing vertebrae to be distracted to a dimension corresponding to the sized corpectomy device. The surgical procedure to prepare the implant site can be difficult and lengthy. Moreover, the procedure can increase risk of trauma to the tissues surrounding of the implant site. 
       SUMMARY OF THE INVENTION 
       [0007]    The instant invention is a longitudinally adjustable corpectomy device which fits within the intervertebral distracted channel. The device includes a means for engaging an extendable member to accommodate the distracted channel. An expanding member moves in relation to a base member in accordance with a rack and pinion type operation. The ratchet mechanism prevents the two members from contracting once expanded. 
         [0008]    An objective of the instant invention to provide a corpectomy device that may be adjusted within the intervertebral cavity or adjusted in situ within the cavity. 
         [0009]    It is a further objective of the instant invention to provide an expandable corpectomy which can be expanded by use of a rack rotated by a removable shaft. 
         [0010]    Yet another objective of the instant invention is to provide vertebra engagable endplates which are arranged to pivot and self adjust. 
         [0011]    Other objectives and advantages of this invention will become apparent from the following description taken in conjunction with any accompanying drawings wherein are forth, by way of illustration and example, certain embodiments of this invention. Any drawings contained herein constitute a part of this specification and include exemplary embodiments of the present invention and illustrate various objects and features thereof. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0012]      FIG. 1  is a side view of the corpectomy device in a compressed position with the pivoting endplate angled forward; 
           [0013]      FIG. 2  is a side view of the corpectomy device in a compressed position with the pivoting endplate angled backward; 
           [0014]      FIG. 3  is a side view of the corpectomy device in a raised position with the pivoting endplate centered; backward; 
           [0015]      FIG. 4  is the opposite side view of  FIG. 3  depicting the pinion driver; 
           [0016]      FIG. 5  is the perspective view illustrating the ratchet mechanism for use in locking the members in position; 
           [0017]      FIG. 6  is a pictorial view depicting the corpectomy device between vertebra in a compressed. position; 
           [0018]      FIG. 7  is another pictorial view of  FIG. 6  from a different perspective; 
           [0019]      FIG. 8  is view of  FIG. 7  with a pinion driver; 
           [0020]      FIG. 9  is view of  FIG. 8  upon rotation of the pinion driver; 
           [0021]      FIG. 10  is a pictorial view depicting the corpectomy device between vertebra in an expanded position; 
           [0022]      FIG. 11  is a pictorial view depicting the ratchet mechanism of the corpectomy device; 
           [0023]      FIG. 12  is a pictorial view depicting the corpectomy device with a top endplate; 
           [0024]      FIG. 13  is a pictorial view of the corpectomy device in position; 
           [0025]      FIG. 14  is a front perspective view of the corpectomy device with mounting tabs; 
           [0026]      FIG. 15  is a rear perspective view with mounting tabs; 
           [0027]      FIG. 16  is an exploded view of  FIG. 13 ; 
           [0028]      FIG. 17  is a left side view thereof; 
           [0029]      FIG. 18  is a front view thereof; 
           [0030]      FIG. 19  is a right side view thereof; 
           [0031]      FIG. 20  is a rear view thereof; 
           [0032]      FIG. 21  is a top view thereof; 
           [0033]      FIG. 22  is a bottom view thereof; 
           [0034]      FIG. 23  is a rear view thereof placed in position; 
           [0035]      FIG. 24  is a right side view thereof placed in position; and 
           [0036]      FIG. 25  is a perspective view thereof place in position. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0037]    Referring now to the Figures, set forth is the corpectomy device  10  in a compressed position with the pivoting endplate  12  angled forward. The corpectomy implant device  10  is defined by a base member  14  telescopingly received an expansion member  16 . The base member  14  is formed from a housing having a lower end  15  with a first  17  and second  19  side walls extending from said lower end  15 . Said base member include end. walls  21  and  23  positioned between said first and second side walls  17 ,  19  each having a centrally disposed U-shaped slot  18  formed therein extending from the lower end along a length of the end walls with a first edge  20  of said slot  18  non-engaging and a second edge  22  lined with an engaging edge, preferably directional ratchet teeth  22 . Lower endplate  12  can be inserted. 
         [0038]    into the open end of the base member  14 , the lower endplate having a surface  11  for use in bone engagement. 
         [0039]    The expansion member  16  is formed from housing having first and second side walls  25  and  27  and first and second end walls  29  and  31 , the four walls constructed and arranged to encompass said base member walls. Side wall  25  includes an aperture  24  sized to permit insertion of pinion tool  30  having a shoulder  32  that allows ease of rotation by bearing upon the side wall  25  with a pinion for engagement of the ratchet teeth  22 . Rotation of the pinion tool  30  provides extension of the expansion member  16  from the base member  14  as the pinion tool is limited in movement with the expansion member  16  by the size of the aperture  24 . 
         [0040]    Positioned with the base member is a spring loaded biasing ratchet assembly  36  having a pair of engagement prongs  38  and  40  that engage the ratchet teeth  22 . The biasing ratchet assembly  36  includes having a biasing member  41  that engages an inner surface of the base member  14  expanding the engagement prongs  38  and  40  against the ratchet teeth  22  wherein the spacing of the extension. member from the base member is unidirectional to prohibit compression of the structure once positioned. The expansion member  16  permits the device to expand relative to the base member  14  and overall longitudinal dimension of the device. Upper endplate  42  can be inserted into the open end of the expansion member  16 , the upper endplate having a surface  44  for use in bone engagement. 
         [0041]    The endplates  12  and  42  may be interchangeably connected or permanently attached, such as laser welded, to the corpectomy device. These endplates may be of any desired shape, size or thickness. For example, the endplate  42  of  FIG. 12  is substantially flat with engagement teeth  44  forming a pattern allowing bone growth material to pass through. In  FIGS. 1-3  the endplate  12  can be moved. at an angle that will allow the implant to restore the normal curvature of the spine after the corpectomy device is installed. Moreover, the shape may or may not correspond to the cross-sectional shape and size (foot print) of the base. In those instances where the patient presents unusual physiology, such as curvature of the spine (lordosis or kyphosis), additional physiology compensating members may be interposed with the respective endplates. These compensating members allow the corpectomy implant device  10  to take on a more arcuate shape thereby conforming more closely with the existing spinal configuration. 
         [0042]      FIG. 2  is a side view of the corpectomy implant device  10  in a compressed position having expansion member  16  placed over the insert of base member  14  with the pivoting endplate  12  angled backward.  FIG. 3  is a side view of the corpectomy implant device  10  in a raised position with the pivoting endplate  12  centered. 
         [0043]      FIG. 4  is the opposite side view of  FIG. 3  depicting the pinion driver  30  inserted into aperture  24 .  FIG. 5  is the reverse perspective view illustrating the biasing ratchet mechanism  36  for use in locking the base member  14  and the expansion member  16  in a raised position. 
         [0044]      FIGS. 6-8 and 13  are pictorial views depicting the corpectomy implant device  10  between vertebra  100  and  102  in a compressed position. 
         [0045]      FIGS. 9-11  depict the device in an expanded state with the pinion driver  30  used to raise the expansion member  16  over the base member  14 . 
         [0046]    Accordingly, in preferred embodiments, a corpectomy device comprises a base member, an expansion member, an upper or lower endplate. 
         [0047]    In another preferred embodiment, the base member comprises a slot having first side wall and a second side wall, wherein the first side wall is smooth and the second side wall comprises one or more teeth, spikes or jagged edges. 
         [0048]    In another preferred embodiment, the expansion member comprises an aperture for receiving a pinion tool having a first shoulder wherein the first shoulder smooth, and a second shoulder for engagement of the base member. 
         [0049]    In yet another preferred embodiment, the corpectomy device comprises a ratchet, the ratchet comprising at least one engagement prong, a biasing member or combinations thereof. 
         [0050]    In yet another preferred embodiment, the upper and lower endplates are interchangeable and comprise patterns, dimensions, shapes, smooth surfaces, grooved surfaces, rough surfaces, or mobility for engaging a vertebra. 
         [0051]    Embodiments of the invention are also directed to methods for manipulating the distance between vertebrae in a patient in need thereof. 
         [0052]    Accordingly, in a preferred embodiment, a method of manipulating the distance between adjacent vertebrae in a patient, comprising surgically inserting an expandable corpectomy device into an intervertebral cavity, the corpectomy device comprising an upper endplate, a lower endplate, a base member wherein the base member is telescopingly receivable into an expansion member; the base member comprising a slot having a first side wall that is smooth and a second side wall lined with teeth; the expansion member having an aperture for receiving a pinion tool for increasing longitudinal distances of the expansion member relative to the base member. 
         [0053]    In some preferred embodiments, the distances between the teeth in the second side wall of the base member aperture are sized so that the expansion can occur by desired increments. 
         [0054]    In another preferred. embodiment, the corpectomy device comprises a spring loaded biasing ratchet having a pair of engagement prongs for engaging the second side wall of the aperture of the base member and a biasing member for engaging an inner surface of the base member. 
         [0055]    In other preferred embodiments, the upper endplate is insertable into an open end of the expansion member, the upper endplate having a surface for bone engagement. Preferably, the upper and lower endplates are interchangeable and comprise patterns, dimensions, shapes, smooth. surfaces, grooved. surfaces, rough surfaces, or mobility for engaging a vertebra. 
         [0056]    Referring to  FIGS. 14-25 , set forth is the corpectomy device having extension tabs for securing to bone. In this embodiment, the endplates can be fastened to bone to eliminate any movement. The corpectomy device of this embodiment employs a base member  114  formed from a housing having a lower end  115  with a first side wall  117  and a second side wall  119  spaced apart and extending therefrom, with opposing end walls. At least one end wall having a centrally disposed U-shaped slot  118  extending from the lower end along a length of the opposing end walls, said U-shaped slot  118  having at least one edge  122  having an engaging surface lower endplate  150  is securable to an end of the base member  114 , the lower endplate  150  includes an extension tab  151  having at least one aperture  152  for receipt of a mounting screw, not shown, for fastening the lower endplate to bone. An expansion member haring first  125  and second side  127  walls and first  129  and second  131  end walls constructed and arranged to encompass said base member side and end wall and permit telescope expansion thereto, one said side of said expansion member including an aperture  124  placed adjacent to said U-shaped slot  118 . An upper endplate  160  securable to an end of said expansion member  116 , said upper endplate  160  including an extension tab  161  having at least one aperture  162  for receipt of a mounting screw, not shown, for fastening the upper endplate  160  to bone. 
         [0057]    A biasing ratchet assembly  136  mounted within the base member having at least one engagement prong operatively associated with the engaging surface  122  and the expansion member  116 . The aperture  124  is sized to receive a pinion tool for use in extending the expansion member  116  in relation to the base member  114 . The engagement prong  138  is insertable into the engaging surface  122  to prevent the expansion member from contracting once telescoped. The upper  160  and lower endplates  150  are securable to point to eliminate any possible movement of the corpectomy device once installed. 
         [0058]    Similar to the previously disclosed embodiments, the centrally disposed U-shaped slot  18  formed therein extends from the lower end along a length of the end walls with a first edge  120  of said slot  118  non-engaging and a second edge  122  lined with an engaging edge, preferably directional ratchet teeth  122 . Lower endplate  150  can be inserted into the open end of the base member  114 , the lower endplate  150  having a surface  111  for use in bone engagement. The lower endplate  150  can be permanently secured to the base member by pin  154  securable to pin lock  155 , such as in a rivet fastener. 
         [0059]    Side wall  125  includes an aperture  124  sized to permit insertion of pinion tool, not shown but the same as element  30  previously mentioned, that allows rotation by bearing upon the side well  125  with a pinion for engagement of the ratchet teeth  122 . Rotation of the pinion tool provides extension of the expansion member  116  from the base member  114  as the pinion tool is limited in movement with the expansion member  116  by the size of the aperture  124 . 
         [0060]    Positioned with the base member is a spring loaded biasing ratchet assembly  136  having engagement prong  138  that engage the ratchet teeth  122 . The biasing ratchet assembly  136  expands against the ratchet teeth  122  wherein the spacing of the extension member from the base member is unidirectional to prohibit compression of the structure once positioned. The expansion member  116  permits the device to expand relative to the base member  114  and overall longitudinal dimension of the device. Upper endplate  160  can be inserted into the open end of the expansion member  116 , the upper endplate having a surface  144  for use in bone engagement. The upper endplate  160  can be permanently secured to the expansion member by pin  164  securable to pin lock  165 , such as in a rivet fastener. 
         [0061]    The  150  and  160  may he interchangeably connected or permanently attached, such as laser welded, to the corpectomy device. These endplates may be of any desired shape, size or thickness. For example, the endplate  160  is substantially flat with engagement teeth  144  forming a pattern allowing bone growth material to pass through, the extension tab  161  providing additional securement. The endplate  150  and  162  can be moved at an angle that will allow the implant to restore the normal curvature of the spine after the corpectomy device is installed. Moreover, the shape may or may not correspond. to the cross-sectional shape and size (foot-print) of the base. In those instances where the patient presents unusual physiology, such as curvature of the spine (lordosis or kyphosis), additional physiology compensating members may be interposed with the respective endplates. These compensating members allow the corpectomy implant device to take on a more arcuate shape thereby conforming more closely with the existing spinal configuration. 
         [0062]    Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted. in an idealized or overly formal sense unless expressly so defined herein. 
         [0063]    As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. Furthermore, to the extent that the terms “including”, “includes”, “having”, “has”, “with”, or variants thereof are used in either the detailed description and/or the claims, such terms are intended to be inclusive in a manner similar to the term “comprising.” 
         [0064]    It is to be understood that while a certain form of the invention is illustrated, it is not to be limited to the specific form or arrangement herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and any drawings/figures included herein. 
         [0065]    One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The embodiments, methods, procedures and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed. within the spirit of the invention and are defined by the scope of the appended claims. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims.