Abstract:
An intervertebral insert member and an instrument for positioning the insert in a space between vertebral bodies in vivo. The insert member is advanced by the instrument into a prepared site located between adjacent vertebral bodies. Upon reaching the appropriate insertion point the sleeve is retracted and a pivotal motion is imparted to the insert. The insert member is pivotally attached to the distal end of the delivery instrument such that it can be articulated about a pivot point that is located on the insert member until it is properly positioned. The positioning instrument is then released from the insert member and removed from the space between the vertebral bodies.

Description:
FIELD OF THE INVENTION 
       [0001]    The invention relates to spinal implants for intervertebral body fusion devices and an instrument for properly inserting the implant between the vertebral bodies. 
       BACKGROUND OF THE INVENTION 
       [0002]    The spine a complex structure capable to performing a broad range of kinematic functions. The spinal vertebrae and elastic disk permit the spine to move in three axes of motion. These axes include rotation, such as twisting of the upper back and shoulders relative to the pelvis, horizontal movement, such as forward (anterior) or backward (posterior), and lateral bending movement to either the right or left side. 
         [0003]    The spacing between adjacent vertebrae is maintained by a disc having both elastic and compressible characteristics. The appropriate spacing in a healthy spine is maintained between adjacent vertebrae during the rotational, horizontal and lateral movement of the spine thereby allowing for maximum freedom of motion of the spine. The spacing between adjacent vertebrae is also critical to allow the nerves radiating from the spine to extend outwards without being pinched or compressed by the surrounding vertebrae. 
         [0004]    Spinal discs can be damaged by physical injury, disease, genetic disposition, aging and become less than fully functional. When this happens the disc is incapable of maintaining the proper intervertebral spacing and so, for example, the nerves radiating from the spine are compressed. Nerve damage could also be caused by exiting root compression in neural foramen, compression of the passing nerve, and an enervated annulus which occurs when the nerves flow into a cracked annulus that results in pain each time the disc is compressed. Obviously other organic abnormalities can occur in the presence of a dysfunctional disc. 
         [0005]    Many solutions have been developed to eliminate or at least minimize nerve compression and the attendant pain that commonly results form spinal nerve pressure. These solutions approach the problem by surgically removing the defective disc and thereafter replacing it with an insert that is subsequently fused to the adjacent discs thereby maintaining an appropriate distance between adjacent vertebrae. While prior insert solutions have been successful in improving the patient&#39;s condition it is somewhat problematic for the surgeon to gain the necessary access to the space between the vertebrae without doing harm to adjacent body structures such as the spinal cord, other nerves, and other adjacent body organs. 
         [0006]    A surgical solution that utilizes a less invasive technique will result in less trauma and unintended damage to surrounding bone, organ, muscle and nerve tissues while achieving the desired results. The present invention relates to an insert that can be advanced into a prepared space between vertebral bodies by a novel instrument and upon reaching the appropriate insertion point a pivotal motion is imparted to the insert to provide proper placement of the insert. The pivotable insert provides the surgeon with the capability to implant the insert using a non linear path. The insertion and placement is achieved in a minimally invasive manner. 
       DESCRIPTION OF THE PRIOR ART 
       [0007]    What is needed, therefore, is an intervertebral insert and delivery instrument that will be minimally invasive. 
         [0008]    U.S. Published Patent Application No. 2008/0009880 discloses a pivotable interbody spacer system includes an insertion instrument configured to manipulate a pivotable interbody spacer during surgical insertion, wherein the insertion instrument includes means for coupling the interbody spacer and a means for fixing the angular position of the interbody spacer. According to one exemplary method for inserting the interbody spacer in a spinal disc space, the interbody spacer is grasped by the insertion instrument and fixed at a first angular position; the interbody spacer is inserted into the surgical site; the interbody spacer is released from the first angular position; the insertion instrument is pivoted about the coupling such that the interbody spacer is in a second angular position; the angular position of interbody spacer is fixed in the second angular position; the insertion process continues until the interbody spacer is positioned in the desired location. 
         [0009]    U.S. Published Patent Application No. 2008/0221694 discloses a spinal spacer system includes a handle member, an extension member including a first and a second end, wherein the first end of the extension member is coupled to the handle member. Additionally, a coupling device configured to selectively couple a spacer to the second end of the extension member is disposed on the extension member including an angular fixation member configured to fix the spacer in an angular position relative to the handle member. The spinal spacer system also includes an actuator configured to selectively actuate the coupling device and the angular fixation member. 
         [0010]    U.S. Published Patent Application No. 2008/0140085 discloses a method to insert a spinal implant into a vertebral space, the method including the steps of: grasping the implant with a distal end of an implant insertion tool; holding a proximal end of the implant insertion tool and inserting the implant toward the vertebral space; and manipulating the proximal end to apply a yaw movement to the implant while the implant is attached to the tool and in the vertebral space. Two slideable rods inside sheath  1514  activate rotation of the spacer implant. 
         [0011]    U.S. Published Patent Application No. 2008/0109005 discloses a system for replacing a natural nuclear disc in an intervertebral space has a spinal device configured for placement in the intervertebral space. An insertion tool is configured for holding the spinal device while the spinal device is inserted into the intervertebral space. A gripping member of the insertion tool has an end for adjustably holding the spinal device within the intervertebral space. A steering actuator of the insertion tool is operatively connected to the spinal device and configured for pivoting the adjustably held spinal device within the intervertebral space while the steering actuator is controlled remotely from the intervertebral space. 
         [0012]    U.S. Published Patent Application No. 2003/0208203 discloses instruments and methods for inserting one or more implants to a surgical site in a patient in a surgical procedure, including minimally invasive surgical procedures are provided. The implant is mountable to the instrument in a reduced profile orientation and after insertion is manipulated with the insertion instrument to the desired orientation. 
         [0013]    U.S. Published Patent Application No. 2008/0065082 discloses an instruments and methods are provided for inserting a rasp into an intervertebral space of a spine and using the rasp to decorticate the adjacent vertebra. More particularly, one embodiment provides an instrument that actively changes the angle of the rasp relative to the instrument. The delivery instrument may use a gear portion to articulate the rasp. A second gear on the rasp may mate with corresponding gear on the instrument. As the instrument gear rotates relative to the instrument, the instrument gear drives the rasp gear, thereby rotating the rasp to decorticate the vertebra. Trial inserts and methods are also provided to determine an appropriate size of a rasp for decortications. 
         [0014]    U.S. Published Patent Application No. 2007/0225726 discloses a method, apparatus, and system are provided to place an insert in a space between boney structures. The insert may be rotatably coupled to the delivery instrument. The delivery instrument may comprise a body and an articulating member. The articulating member may slidably interact with the insert to rotate the insert about a pivot point. A first actuator is operatively coupled to the articulating member such that actuating the first actuator translates the articulating member relative to the body. An engagement member may be coupled to the body and adapted to releasably and rotatably secure the insert to the delivery instrument. The articulating member and the engagement member may be offset from each other in such a manner that when the articulating member engages the insert, the insert rotates relative to the delivery instrument. Alternatively, the insert may be coupled to the delivery instrument via rotatable attachment members. 
         [0015]    U.S. Published Patent Application No. 2005/0192671 discloses an artificial disc device for replacing a damaged nucleus is disclosed. In one form, the device may be inserted in components such that the device may be assembled within and retained by the natural annulus therein. In another form, the device may be inserted into the natural annulus in a collapsed or compressed state or arrangement and then be expanded within and retained by the annulus therein. In a further form, the device may be provided with a releasable connection so that the device may be connected in an insertion configuration and may be released in an operable configuration. 
       SUMMARY OF THE INVENTION 
       [0016]    The instant invention is comprised of an insert that is positioned in a prepared space between adjacent vertebrae. The insert has a approximately centrally located pivot post and a curved end portion each configured to cooperatively engage an instrument to advance the insert into an appropriate position. Various components of the instrument are manipulated to achieve the final placement of the insert. The instrument is then disengaged from the insert and removed from the patient. 
         [0017]    Accordingly, it is an objective of the instant invention to provide a spinal insert that is easily and accurately placed within a prepared space between two vertebrae using a minimally invasive technique. 
         [0018]    It is a further objective of the instant invention to provide a surgical instrument configured to be operatively connected to the implantable insert that can be used by the surgeon to accurately placed the insert within the inter vertebral space using a minimally invasive technique. 
         [0019]    It is yet another objective of the instant invention to provide simple and reliable mechanical relationships between the insert and the surgical instrument to provide a minimally invasive approach to implanting a spinal insert. 
         [0020]    It is a still further objective of the invention to provide an insert that will stabilize the spine and promote bone growth between adjacent vertebrae such that adjacent vertebrae are fused together. 
         [0021]    Other objects and advantages of this invention will become apparent from the following description taken in conjunction with any accompanying drawings wherein are set 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 
         [0022]      FIG. 1  is a top view of the implantable insert. 
           [0023]      FIG. 2  is a side view of the implantable insert. 
           [0024]      FIG. 3  is a bottom view the implantable insert. 
           [0025]      FIG. 4  is a side view of the implantable insert opposite to that shown in  FIG. 2 . 
           [0026]      FIG. 5  is a perspective view of the surgical instrument utilized to implant the insert. 
           [0027]      FIG. 6  is a side view of the surgical instrument and implantable insert. 
           [0028]      FIG. 7  is a top view of the surgical instrument and implantable insert. 
           [0029]      FIG. 8  is a side view of the surgical instrument and implantable insert opposite to that shown in  FIG. 6 . 
           [0030]      FIGS. 9A ,  9 B,  9 C,  9 D, and  9 E show the placement of the insert and the operative relationship of the surgical instrument at various stages of the insertion procedure. 
           [0031]      FIG. 9F  shows an alternative embodiment that utilizes a threaded implant interface. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0032]      FIG. 1  is a top view of implantable insert  1 . Insert  1  is generally arcuate in shape and has a top surface  2  and a bottom surface  4 . Connecting top surface  2  and bottom surface  4  is a convex edge  6  on one side and a pair of concave edges  8 A and  8 B on the second, opposite side. The edges have first end portions  10 A and  10 B and second end portions  12 A and  12 B. A first curved portion  14  connects first end portions  10 A and  10 B and a second curved portion  14  connects second end portions  12 A and  12 B. Located on the top surface  2  is a plurality of apertures  18 A. Likewise, bottom surface  4  has a plurality of apertures  18 B. Apertures  18 A and  18 B form a substantially hollow center within the insert  1 . The hollow cavity within the insert is used to deliver a bone growth material to fuse the adjacent vertebrae together. The insert  1  is relatively small in overall size while providing both a large surface for support and a large cavity to provide bone growth material. A slotted passageway  20  is formed on the second side surfaces including the entire length of concave surface  8 B and a portion of concave surface  8 A. The slot  20  also is continued through first curved portion  14 . Insert  1  also includes a first cylindrical post  22  extending between, and attached to, the top surface  2  and bottom surface  4  at a first end portion of the insert  1 . Likewise, a second cylindrical post  24  extending between, and attached to, the top surface  2  and bottom surface  4  at a second end portion of the insert  1 . A third cylindrical post  26  is located approximately midway between the first and second post in a location adjacent to the area where concave surfaces  8 A and  8 B approach one another. 
         [0033]      FIG. 2  is a side view of insert  1  showing the pair of concave surfaces  8 A and  8 B, first curved portion  14  and second curved portion  16 . Also shown in  FIG. 2  is slotted passageway  20  which extends from concave surface  8 A, through concave surface  8 B and continues into first curved portion  14 . Also illustrated in  FIG. 2  is a first post  22  and third post  26 . 
         [0034]      FIG. 3  is a bottom view of insert  1  showing bottom surface  4  convex surface  6  on the first side and the pair of concave edges  8 A and  8 B on the second side as well as first curved portion  14  and second curved  16 . Also illustrated in  FIG. 3  are apertures  18 B. 
         [0035]      FIG. 4  is a side view of insert  1  that showing the alternative side to that shown in  FIG. 2  showing the convex surface  6  on the first side as well top surface  2 , bottom surface  4 , first curved portion  14  and second curved portion  16 . Also shown is in  FIG. 4  is a portion of slotted passageway  20 . As can best be seen in  FIG. 4  the top surface  2  and bottom surface  4  are generally domed shaped with the high points  4 A and  2 A of each dome being located in the area surrounding the areas where the third cylindrical post  26  connects to the top and bottom surfaces respectively. These high points will form contact points with adjacent vertebrae thereby facilitating pivotal motion of the insert about the third post  26 . 
         [0036]      FIG. 5  is a perspective view of insert  1  mounted on surgical instrument  30  prior to implantation. The instrument  30  includes a sleeve  32  and an arm  34 . The arm  34  is mounted for relative reciprocal longitudinal movement with respect to sleeve  32 . The sleeve  32  includes a guide rail  36 . The guide rail  36  presents two tracks formed with one formed on each side of a slot designed to receive arm  34 . The arm  34  includes profiled surfaces formed on opposite sides of the arm  34  that are configured to operatively engage the tracks formed on the guide rail  36 . The sleeve  32  also includes a pair of curved surfaces  42  formed on opposite side of sleeve  32  that are shaped to mate with the first curved portion  14  of insert  1 . 
         [0037]      FIG. 6  is a side view of insert  1  attached to surgical instrument  30 . In this view concave surfaces  8 A and  8 B of the first side are shown. Also shown is this view is sleeve  32 , arm  34 , guide rail  36  and a gripping mechanism  40 . 
         [0038]      FIG. 7  is a top view of the insert  1  attached to the surgical instrument  30 . In this view top surface  2  of the insert  1  is shown. As shown in this figure surgical instrument  30  includes sleeve  32 , with mating surface  42 , arm  34  and gripping mechanism  40 . 
         [0039]      FIG. 8  is a side view of insert  1  and surgical instrument  30  showing the side opposite to that shown in  FIG. 6 . Convex surface  6  on insert  1  can be seen in this view. Also shown in this view is the sleeve  32  and gripping device  40  of surgical instrument  30 . 
         [0040]      FIGS. 9A through 9E  show the placement of the insert within the prepared space between the vertebrae and the operative relationship of the surgical instrument and the insert at various stages of the procedure. As shown in  FIG. 9E , arm  34  has a recess  46  that includes an aperture that is cylindrical in cross section. The recess can receive the third post  26  and is capable of retaining or releasing the post dependent upon on direction of the forces applied thereto. As shown in  FIG. 9A , post  26  on insert  1  has been position within recess  46  on arm  34 . Likewise, the first end portion  10  on insert  1  is positioned to be in mating relationship with curved mating surfaces  42  located on sleeve  32 . The insert  1  as shown in  FIG. 9A  is then inserted into the prepared site between adjacent vertebrae. Thereafter, instrument  30  is then manipulated by gripping device  40  to advance the insert  1  toward a point that would be appropriate for rotation of the insert  1 . Upon reaching the pivot point the sleeve  32  is retracted as shown in  FIG. 9B  and the instrument  30  is moved medially to impart the initial rotation. At this point the instrument  30  is tamped slightly to impart a small amount of rotation to the insert  1 . Having been positioned as shown in  FIG. 9C  the sleeve  32  is advanced such that a corner portion  44  on the sleeve  32  makes contact with the first end portion of the insert  1 . The further advancement of sleeve  32  will result in the rotation of insert  1  about the post  26  which is retained in position by arm  34 . Additional tamping of the instrument  30  may be necessary. The sleeve  32  is advanced until the insert is rotated into its final position as shown in  FIG. 9D . At this point the sleeve  32  is retracted and the mating surfaces  42  are withdrawn from engagement with the first end portion  10 . As shown in  FIG. 9E  the instrument  30  is then manipulated such that the post  26  is removed from recess  46  and the instrument  30  is then released from the insert  1 . At this point the instrument  30  is removed from the prepared site. Bone growth material is provided in the hollow cavity formed within the insert  1 . Apertures  18 A and  18   b  permit bone in growth with the insert  1  and adjacent vertebrae. As an alternative to the recess shown in  FIG. 9E  the arm  34  is provided with a threaded implant interface in the form of an externally threaded pin  48  that will threadably engage and disengage from a threaded bore that extends transversally to the longitudinal axis of the post  26 , as shown in  FIG. 9F . 
         [0041]    All patents and publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains. All patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. 
         [0042]    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. 
         [0043]    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 not 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.