Abstract:
A method is provided for manipulating a spinal body spacer for use in spinal surgery on a patient. The method includes attaching a placement tool to the spinal body spacer and manipulating the placement tool so as to locate the spinal body spacer in a desired location. The placement tool can by removed by unscrewing the placement tool from a threaded receiving aperture of the spinal body spacer. The method also includes passing a tip of an extraction tool through the threaded receiving aperture of the spinal body spacer, the tip of the extraction tool having at least one tab. The tip of the extraction tool is rotated such that the at least one tab of the tip of the extraction tool passes through keyways of the spacer and extends into the interior space of the spinal body spacer.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a divisional of co-pending U.S. patent application Ser. No. 12/074,478, filed Mar. 3, 2008, which claims the benefit of the filing date of U.S. Provisional Patent Application No. 60/904,691, filed Mar. 1, 2007, which applications are incorporated herein by reference in their entirety. 
     
    
     FIELD 
       [0002]    The present invention relates to medical devices. More particularly, the invention relates to interbody spacer devices and methods for their placement and extraction in spinal surgeries and therapies. 
       BACKGROUND 
       [0003]    Interbody spacers are used as aids in various spinal surgeries. When a spinal disc has suffered disease or trauma, degeneration of one or more discs may result. Depending on the medical indications of the damaged spine, a surgical treatment may be called for. For example, spinal surgeries may call for the full or partial removal of a spinal disc. In other procedures, an implant or support may be used to stabilize elements of the spine in order to assist in the healing process. Various devices have been developed, some known as interbody spacers or spreaders, for use in one or more spinal surgeries. While these devices can be used in a variety of different surgeries and treatments, in several known surgical procedures it is necessary to physically implant an interbody spacer in a desired location relative to the spine. Later, depending on the treatment, the interbody spacer may or may not be removed from the patient. 
         [0004]    However, the existing spacers suffer from a limited ability to extract and reposition the interbody spacer device. The limitation on repositioning is noted both during the initial placement and also later after the initial placement has occurred. This limitation is experienced in current devices, systems, and surgical procedures. This limitation introduces additional potential risks to the patient. With current systems and procedures, the need to remove or reposition an interbody spacer can present a significant risk to the patient&#39;s spinal cord, nerve roots, and dural sack. The fear of working with extraction tools in close proximity to the spinal cord may lead surgeons to perform more invasive techniques, such as a partial corpectomy, to retrieve the device without damaging the spinal cord. Similarly, a surgeon may settle for an imperfect placement due to the risk associated with introducing tools to reposition the device and a lack of options for repositioning. Hence, in order to overcome these limitations, it would be desired to provide an interbody spacer device that provides increased movement and flexibility after the initial positioning. 
         [0005]    The device described herein allows a retrieval tool to be locked into the spacer block to ease removal or repositioning of the innerbody spacer. It can be configured in dimensions appropriate for transforaminal lumbar interbody fusion (TLIF), posterior lumbar interbody fusion (PLIF), and anterior lumbar interbody fusion (ALIF) procedures and is not limited to any one technique. The block is inserted using a newly developed threaded rod assembly using an insertion technique that is similar to techniques currently described by other manufacturers of TLIF devices. The device would preferably be manufactured from a material such as a PEEK or similar material. The block could be offered with multiple angle and height options to restore the proper lordosis and spacing at the level of fusion. The block contains voids with interconnections to allow bone graft or bone substitute to be packed inside and to promote tissue ingrowth within the spacer. 
         [0006]    One innovation is the incorporation of an extraction tool that can be inserted and locked into the implant, allowing it to be pulled out with the aide of a slap hammer, or other surgical hammer, that allows for incremental movements and mitigates the risk of damaging the dural sac or spinal cord. The extraction tool consists of a blunt face “key” that can be passed into the spacer block and is then rotated 90 degrees to a positive stop so it cannot be withdrawn. 
         [0007]    In most cases the need to remove the device will become apparent before significant tissue ingrowth and bone fusion have occurred. This may be due to incorrect initial positioning by the surgeon, infection shortly after surgery, or failure of a vertebral body. These issues usually become apparent within several weeks after initial surgery. 
         [0008]    In the event that the implant has been in place for some time and significant scar tissue or trabecular bone ingrowth has occurred, an alternative tool, with a much sharper profile can be used to clear the inner void of the spacer and improve the chances of recovering the implant without resorting to more invasive methods. 
       SUMMARY 
       [0009]    In one embodiment, and by way of example only, there is provided an instrument set for use in spinal surgery that includes: a spinal body spacer having a threaded opening and keyways connected to the threaded opening; a placement tool having a threaded tip for connecting with the threaded opening of the spacer; and an extraction tool with a tip configured to pass through the opening of the spacer, and the tool having tabs positioned on the tip such that the tabs pass through the keyways of the spacer. The spacer may have an outer face positioned around the opening and the placement tool may also have a contact face such that the contact face comes into contact with the outer face when the placement tool is fully connected with the spacer. The spinal body spacer may also include a superior surface and an inferior surface with a plurality of antimigration furrows positioned on each of the superior surface and the inferior surface. The tip of the extraction tool may be a substantially blunt tip, a substantially pointed tip, or even a tip with a hollow area. The spacer may have at least one block disposed on an interior surface such that the block contacts the tabs of the extraction tool thereby restricting rotation of the extraction tool relative to the spacer. The spacer may have a backing plate, and the backing plate may itself include projections disposed in the matrix of the spacer. The instrument set may further include a slap hammer having a keyed end configured to attach to the spacer. The spacer may be constructed with a body having a first wall and a second wall connected by a top face, a bottom face, and a lateral support. 
         [0010]    In a further embodiment, still by way of example only, there is provided a method for manipulating a spinal interbody spacer for use in spinal surgery on a patient, in which the method includes the steps of: attaching a positioning tool to a spacer by screwing a threaded end of the positioning tool to threaded receiving aperture of the spacer; manipulating the positioning tool so as to locate the spacer in a desired location; and removing the positioning tool by unscrewing it from the threaded portion of the spacer. The method may further include the step of receiving positioning information from the spacer through radio opaque markets located in the spacer. Additionally the method may include the step of attaching a positioning tool and contacting a contact face positioned on the positioning tool with a reciprocal face positioned on the spacer so as to transfer force from the positioning tool to the spacer. Additionally, the method allows the step of securing the spacer to the surgical patient. Finally, the method may be used with further steps such as: sliding the tip of an extraction tool through an aperture in the spacer; rotating the tip of the extraction tool until tabs located on the extraction tool contact blocks positioned on the spacer; and pulling on the extraction tool so as to exert a force on the spacer. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]      FIG. 1  is a perspective view of an interbody spacer device having a face with a keyway passage, according to an embodiment of the present invention; 
           [0012]      FIG. 2  is an additional perspective view of an interbody spacer device having a face with a keyway passage, according to an embodiment of the present invention; 
           [0013]      FIG. 3  is a further perspective view of an interbody spacer device showing stop blocks in an inner face, according to an embodiment of the present invention; 
           [0014]      FIG. 4  is a perspective view of a keyed extraction tool aligning with the keyway passage of an interbody spacer, according to an embodiment of the present invention; 
           [0015]      FIG. 5  is a perspective view of an extraction tool engaged with an interbody spacer, according to an embodiment of the present invention; 
           [0016]      FIG. 6  is a perspective view of an extraction tool engaged and rotated to the locked position with an interbody spacer, according to an embodiment of the present invention; 
           [0017]      FIG. 7  is a close up perspective view of an extraction tool with a sharpened tip engaged with an interbody spacer, according to an embodiment of the present invention; 
           [0018]      FIG. 8  is a perspective view of a slap hammer and extraction tool assembly, according to an embodiment of the present invention; 
           [0019]      FIG. 9  is a close up perspective view of a blunt tip of an extraction tool, according to an embodiment of the present invention; 
           [0020]      FIG. 10  is a close up perspective view of a sharp tip of an extraction tool, according to an embodiment of the present invention; 
           [0021]      FIG. 11  is a close up perspective view of a hollow tip of an extraction tool, according to an embodiment of the present invention; 
           [0022]      FIG. 12  is a close up perspective view of a tip of an insertion tool, according to an embodiment of the present invention; 
           [0023]      FIG. 13  is a perspective view of an insertion tool engaged with an interbody spacer, according to an embodiment of the present invention; 
           [0024]      FIG. 14  is a perspective view of an interbody spacer with a backing plate behind one face, according to an embodiment of the present invention; 
           [0025]      FIG. 15  is a perspective view of an interbody spacer having securing projections connected to the backing plate, according to an embodiment of the present invention; and 
           [0026]      FIG. 16  is a further perspective view of an interbody spacer having radio opaque markers, according to an embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0027]    The following detailed description of the invention is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Furthermore, there is no intention to be bound by any theory presented in the preceding background of the invention or the following detailed description of the invention. Reference will now be made in detail to exemplary embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. 
         [0028]    There is now described a set of elements which may be used in combination as an assembly or individually as an instrument set or a medical or surgical kit. Furthermore a method will be described for advantageously using the elements of the kit so as to overcome limitations previously described in the prior art for spinal spacers and implants. 
         [0029]    Referring now to  FIG. 1 , the figure demonstrates an exemplary shape of a spinal interbody spacer  10 . Spacer  10  includes threads  11  which allow a placement technique using a threaded rod assembly. The threaded rod (not shown) can engage with the threads  11  so as to allow a manipulation of the spacer  10  by the rod. The cutouts  12  shown in face  14  surrounding aperture  13  allow an extraction tool to pass through the same aperture  13  as the insertion rod. As more fully explained herein, the tip of the extraction tool passes through this keyway, toward an interior position, where the extraction tool can then be locked into position. 
         [0030]      FIG. 2  displays a lateral view of the spacer  10  showing anti-migration furrows  21  on the superior  22  and inferior  23  surfaces. This is one non-limiting embodiment of the positioning of anti-migration furrows  21 . As is known in the art, anti-migration furrows may be advantageously used in order to secure spacer  10  in a desired location and to minimize the risk of movement of the spacer. 
         [0031]      FIG. 3  displays a further view of the spacer  10 , according to a preferred embodiment. This figure shows stop blocks  31  positioned on an inner face  32  of the spacer. The stop blocks  31  can be used in conjunction with the extraction tool (not shown). As previously explained, the tip of the extraction tool can pass through the aperture  13  of spacer  10  to an interior position. The tip of the extraction tool can then be rotated until tabs on the tip come into contact with the stop block  31  of  FIG. 3 . The stop block thus limits the rotation of the extraction tool to approximately 90 degrees, for example. Once the retrieval or extraction tool has been rotated to this extent, the surgeon knows that the tool is properly positioned to effect an extraction of the spacer. 
         [0032]    Referring generally to  FIGS. 1 ,  2 , and  3 , it is further noted that the preferred embodiment of spacer  10  can include walls such as a first wall  35  and second wall  36 . Walls  35  and  36  may define interior surfaces  37 . Further, spacer  10  may include a lateral support  38  which can connect a preferred embodiment of a first wall  35  and a second wall  36 . As will be appreciated by those skilled in the art, the overall structure of spacer  10  can vary; however, the preferred embodiment can assist in placement of the spacer in a human patient. Windows  39 , optionally configured in walls  35  and  36  can also assist in various surgical procedures such as placement, visual location, and positioning, while also providing areas for tissue connection to the spacer  10 . Any cavity  29 , constituting an internal space defined by walls  35  and  36  and a top face  28  or  14  and bottom face  27  and lateral support  38  would be of a size so as not to interfere with the interaction between spacer  10  and a tool as described further herein. 
         [0033]    Referring now to  FIG. 4 , there is illustrated an exemplary shape of the tip  41  of an extraction tool  42 . In  FIG. 4 , the tip  41  of the extraction tool  42  has been positioned proximate the face  14  of the spacer  10  such that tabs  43  on the extraction tool  42  are aligned with the key way passages  12  on the face  14 . The tool  42  is thus in the proper position to be inserted past the key way  12  to the interior of the spacer  10 . 
         [0034]      FIG. 5  illustrates the extraction tool  42  with its tip  41  fully inserted to the interior position of the spacer  10 . The tip  41  of the extraction tool  42  is in a position that it can now be rotated to the 90 degree stops  31 . It is noted that the extraction tool  42  must be sufficiently inserted such that the tabs  43  positioned on the extraction tool  42  tip  41  have cleared the interface structure of the spacer  10 , thus leaving the tabs  43  free to be rotated. 
         [0035]    Referring next to  FIG. 6 , the extraction tool  42  has been fully rotated to its locked position. In a preferred embodiment, this degree of rotation is approximately 90 degrees, though other degrees of rotation can be chosen. Further, the tool  42  cannot now be extracted without turning back to the original orientation. 
         [0036]    It is further noted that in a preferred embodiment the tabs  43  of the extraction tool  42  tip  41  and the interior surface of the spacer face are constructed so as to mutually cooperate so as to facilitate extraction. In the embodiment illustrated, the surface of the tabs  43  that contacts the interior surface  32  of the spacer  10  is substantially flat or planar. Likewise, the interior surface  32  of the spacer  10  is substantially flat or planar. In this manner, when the extraction tool  42  has been inserted into the spacer  10 , and rotated to the fullest possible extent, the extraction tool  42  can then be pulled or manipulated so that the tabs  43  make contact with the interior surface  32 . At that point of contact force is transferred from the extraction tool  42  to the interbody spacer  10 . The mutually flat surfaces thus allow for a good mechanical transfer of force. 
         [0037]    Referring now to  FIG. 7 , there is illustrated an alternative embodiment of an extraction tool tip  41 . A sharper version of the extraction tool tip  41 , as illustrated, can be used when tissue ingrowth limits the ability of a blunt tipped extractor  42  to be inserted. The sharp tip  71  can more easily cut, crush, and dislodge material within the hollow structure in order to reach its desired fully inserted position. Further this step of cutting through and dislodging tissue ingrowth can assist in providing adequate room within the spacer chamber so as to permit the tool  42  to rotate into the locked position.  FIG. 9  provides a close up illustration of a blunt ended tool tip  91 , which is also one embodiment of the device.  FIG. 10  provides a close up illustration of a sharp tool tip  71 , a further embodiment which may be preferred for use in those situations when it is not possible to insert a blunt tipped device due to tissue ingrowth. 
         [0038]    Referring now to  FIG. 11 , there is illustrated an additional embodiment of an extraction tool tip. This embodiment, having a partially or substantially hollow tip  110  presents an alternative design of a tip for use with those situations having tissue ingrowth. The hollowed tip  110  will displace and disturb less material than other embodiments when inserted into the spacer  10 . However, the sharpened edges  111  of the hollow tip  110  will cut through scar tissue and trabecular bone. Thus, the tip  110  can be fully inserted so as to allow tip rotation. 
         [0039]    At this point, a summary of the use of spacer  10  and extraction tool  42  will here be described. Once spacer  10  has been initially positioned, it may become necessary to remove and/or adjust the positioning of spacer  10 . This can be conveniently achieved by assembling the extraction tool  42  with the spacer  10 . As previously the tip of the extraction tool  42  is fed through the aperture. The tip must be aligned such that the tabs  43  can pass through the key ways. The tip is sufficiently passed through the aperture until the tabs  43  attached to the tip have passed into the void defined by the spacer  10 . In moving the extraction tool, such as passing it through the aperture, a handle or other type of grabbing device may be used on the opposite end of the extraction tool in order to manually manipulate the tool. At this level of clearance, the extraction tool can be rotated such that the tabs  43  on the extraction tool tip have rotated out of alignment with the keyways. A physical confirmation that this has occurred is done by rotating the tool until the tabs  43  come into contact with the blocks  31  positioned on the spacer. At this point the surgeon, or individual handling the extraction tool, can pull on the extraction tool. This manual force is transferred to the spacer where the tabs  43  make contact with the interior surface of the spacer. 
         [0040]    Referring now to  FIG. 8 , there is illustrated a slap hammer assembly  81  with a keyed end  82 . The slap hammer  81  can be disassembled and reassembled in the OR (operating room) by unscrewing the end cap to allow the surgeon to place the key into the block without the mass of the slap assembly limiting dexterity and making insertion of the key difficult. The slap hammer  81  takes advantage of the interoperability designed into the existing system between spacer  10  and extraction tool  42 . The keyed end  82  of hammer  81  can be designed to engage spacer  10  by passing through the aperture, and rotating until keys make contact with blocks, in a manner similar to that described with respect to extraction tool  42 . The keyed end  82  can then be assembled with a hammer portion, if needed. The hammer can then operate under known principles, such as for example momentum hammering as is known in the art. The use of slap hammer  81  would be recommended in those situations where a manual manipulation of an extraction tool would not be sufficient. 
         [0041]    Referring next to  FIG. 12 , there is illustrated a preferred embodiment of the tip portion  121  of an insertion or placement tool  122 . The end portion of the rod  122  includes a threaded rod portion  123 . This threading  123  is reciprocal threading to that threading  11  on the spacer device  10  (as shown in  FIG. 1 ) and thus allows the placement tool  122  to engage with the interbody spacer  10 . When so engaged with the spacer, movement or manipulation of the placement tool  122  can be used to place the interbody device in a desired position. 
         [0042]      FIG. 12  also illustrates that the placement tool  122  preferably includes a flared contact face  124 . This contact face  124  is brought into contact with a reciprocal face  14  on the interbody spacer  10  when the tool  122  is fully engaged with the spacer  10 . In this manner force from the placement tool  122  that is transferred to the interbody spacer  10  is applied not only to the threading  123  but also along the contact face  124 . This distributed contact allows the placement tool  122  to ease stress on the threads  123  and distribute force across the face of the implant  10 . Also note, in a further preferred embodiment, the chamfered shape to ease withdrawal of the rod and prevent snagging on sensitive tissues. 
         [0043]      FIG. 13  shows the insertion rod  122  fully screwed into the interbody device  10 . Preferably, the rod tip  121  does not insert far enough to disturb bone graft materials packed into the void  15 . As shown, the assembly brings the contact face  124  of the placement tool  122  into contact with the spacer face  14 , and thus serves to distribute those forces that might otherwise compromise the plastic screw threads. 
         [0044]    Referring now to  FIGS. 14 and 15 , there is illustrated a further embodiment of an interbody spacer  10 . In this embodiment, the spacer  10  includes a backing plate  140 . Preferably the backing plate  140  is positioned on an interior surface  32  of the spacer  10  as best shown in  FIG. 14 . Preferably the backing plate  140  is made of a metal or hardened material. An advantage of the backing plate  140  is realized when an extraction tool  42  is fully positioned so as to remove or extract a spacer  10 . In such an assembly, the tabs  43  of the extraction tool  42  will now come into contact with the backing plate  140 . The hardened nature of the backing plate  140  provides a sturdy platform for receiving force from the extraction tool  42 . Preferably, the surface  141  of the backing plate substantially matches the surface  32  of the spacer interior surface  32  on which it rests. Thus, the backing plate  140  can distribute force over a wide area. Also advantageously, the backing plate  140  further reduces the possibility that the interbody spacer  10  may crack or break apart during extraction. 
         [0045]    In a preferred embodiment, the backing plate is connected to projections  150 , as best shown in  FIG. 15 . The projections  150  aid in the attachment of the backing plate  140  to the spacer  10 . For example, projections  150 , which pass from the backing plate  140  into the matrix of the interbody device  10 , allow the plate  140  to be secured in place at the time of molding by, in one method, interdigitating with the plastic while it is still malleable. Thus projections  150  allow for a sturdy and robust connection between the plate  140  and the body of the spacer  10 . 
         [0046]    Referring now to  FIG. 16  there is shown a further embodiment of an interbody spacer  10 . In this figure, radio opaque markers  160  are indicated by stars. Such structures can be placed on or connected to the interbody spacer  10  to assist in placement of the spacer  10 . The markers  160  are preferably fabricated of a material that will be identified by a detecting or monitoring instrument, such as for example, radiography or ultrasound. The position of the markers  160 , and therefore the position of the spacer  10 , can thus be detected in order to assist with placement. The placement of the markers in  FIG. 16  is exemplary only. 
         [0047]    The device described herein allows a retrieval tool to be locked into the spacer block to ease removal or repositioning of the innerbody spacer. It can be configured in dimensions appropriate for transforaminal lumbar interbody fusion (TLIF), posterior lumbar interbody fusion (PLIF), and anterior lumbar interbody fusion (ALIF) procedures and is not limited to any one technique. The block is inserted using a newly developed threaded rod assembly using an insertion technique that is similar to techniques currently described by other manufacturers of TLIF devices. The device would preferably be manufactured from a material such as a PEEK or similar material. The block could be offered with multiple angle and height options to restore the proper lordosis and spacing at the level of fusion. The block contains voids with interconnections to allow bone graft or bone substitute to be packed inside and to promote tissue ingrowth within the spacer. 
         [0048]    While the invention has been described with reference to a preferred embodiment or embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to a particular embodiment disclosed as the best mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the general description.