Abstract:
An intervertebral disc placement system includes a multi part intervertebral disc, such as a mobile core disc, and an associated placement instrument. The placement instrument holds the disc securely with the disc endplates angled for ease of placement of the disc into an intervertebral disc space and quickly releases the implant within the disc space. The disc includes upper and lower plates having notches in inner surfaces for engagement of the placement instrument. The placement instrument has a rotatable key configured to fit into the first and second notches to grasp the disc from the interior and eliminate the need for an external grasping mechanism which could interfere with disc placement.

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional Application No. 61/018,441 filed Jul. 17, 2008, entitled “ARTIFICIAL INTERVERTEBRAL DISC PLACEMENT SYSTEM” the full disclosure of which is incorporated herein by reference. 
    
    
     STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT 
     NOT APPLICABLE 
     BACKGROUND OF THE INVENTION 
     The present invention relates to medical devices and methods. More specifically, the present invention relates to intervertebral disc prostheses. 
     Back pain takes an enormous toll on the health and productivity of people around the world. According to the American Academy of Orthopedic Surgeons, approximately 80 percent of Americans will experience back pain at some time in their life. On any one day, it is estimated that 5% of the working population in America is disabled by back pain. 
     One common cause of back pain is injury, degeneration and/or dysfunction of one or more intervertebral discs. Intervertebral discs are the soft tissue structures located between each of the thirty-three vertebral bones that make up the vertebral (spinal) column. Essentially, the discs allow the vertebrae to move relative to one another. The vertebral column and discs are vital anatomical structures, in that they form a central axis that supports the head and torso, allow for movement of the back, and protect the spinal cord, which passes through the vertebrae in proximity to the discs. 
     Discs often become damaged due to wear and tear or acute injury. For example, discs may bulge (herniate), tear, rupture, degenerate or the like. A bulging disc may press against the spinal cord or a nerve exiting the spinal cord, causing “radicular” pain (pain in one or more extremities caused by impingement of a nerve root). Degeneration or other damage to a disc may cause a loss of “disc height,” meaning that the natural space between two vertebrae decreases. Decreased disc height may cause a disc to bulge, facet loads to increase, two vertebrae to rub together in an unnatural way and/or increased pressure on certain parts of the vertebrae and/or nerve roots, thus causing pain. In general, chronic and acute damage to intervertebral discs is a common source of back related pain and loss of mobility. 
     When one or more damaged intervertebral discs cause a patient pain and discomfort, surgery is often required. Traditionally, surgical procedures for treating intervertebral discs have involved discectomy (partial or total removal of a disc), with or without fusion of the two vertebrae adjacent to the disc. Fusion of the two vertebrae is achieved by inserting bone graft material between the two vertebrae such that the two vertebrae and the graft material grow together. Oftentimes, pins, rods, screws, cages and/or the like are inserted between the vertebrae to act as support structures to hold the vertebrae and graft material in place while they permanently fuse together. Although fusion often treats the back pain, it reduces the patient&#39;s ability to move, because the back cannot bend or twist at the fused area. In addition, fusion increases stresses at adjacent levels of the spine, potentially accelerating degeneration of the adjacent discs. 
     In an attempt to treat disc related pain without fusion, an alternative approach has been developed, in which a movable, implantable, artificial intervertebral disc (or “disc prosthesis”) is inserted between two vertebrae. A number of different artificial intervertebral discs are currently being developed. For example, U.S. Patent Application Publication Nos. 2005-0021146, 2005-0021145, and 2006-0025862, which are hereby incorporated by reference in their entirety, describe artificial intervertebral discs. This type of intervertebral disc has upper and lower plates positioned against the vertebrae and a mobile core positioned between the two plates to allow articulation, translation and rotational motion between the vertebrae. 
     Another example of an intervertebral disc prostheses having a movable core is the CHARITE artificial disc (provided by DePuy Spine, Inc.) and described in U.S. Pat. No. 5,401,269. Other examples of intervertebral disc prostheses include MOBIDISC (provided by LDR Medical), the BRYAN Cervical Disc (provided by Medtronic Sofamor Danek, Inc.), and the PRODISC (from Synthes Stratec, Inc.) and described in U.S. Pat. No. 6,936,071. Some of these intervertebral discs are mobile core discs while others have a ball and socket type two piece design. Although existing disc prostheses provide advantages over traditional treatment methods, improvements are ongoing. 
     These known artificial intervertebral discs generally include upper and lower plates which locate against and engage the adjacent vertebral bodies, and a core for providing motion between the plates. The core may be movable or fixed, metallic, ceramic or polymer and generally has at least one convex outer articulation surface which mates with a concave articulation recess on one of the plates in a fixed core device. In a movable core device two sets of articulation surfaces are provided. In order to implant these intervertebral discs, the natural disc is removed and the vertebrae are distracted or forced apart in order to fit the artificial disc in place. The plates may be inserted individually or together and with or without a core. It is desirable to reduce the duration of the artificial disc procedure by implanting the disc in an assembled configuration. However, when holding the disc for implantation it is desirable to prevent contact of the placement tool with the bone integration surface of the disc to avoid damage to any bone integration structures or coatings thereon. 
     Currently available artificial intervertebral discs are held and delivered with a variety of different instruments and techniques. It would be desirable to provide a disc system with a simple placement instrument which easily and securely grasps the implant for insertion. 
     In addition, it would be desirable to hold the disc in the implantation instrument in an articulated or angled insertion configuration to prevent the need for over distraction of the disc space. 
     Therefore, a need exists for an improved artificial intervertebral disc placement system which securely and easily holds the articulating plates of the disc in a fixed arrangement suitable for placement of the disc. 
     BRIEF SUMMARY OF THE INVENTION 
     According to the invention there is provided an artificial disc placement system including a placement instrument with a quick and easy assembly mechanism and quick deployment. 
     In accordance with one aspect of the invention, an intervertebral disc placement system includes an artificial disc and a placement instrument. The artificial disc comprises an upper plate having an upper vertebra contacting surface and a lower surface having a bearing surface thereon; a lower plate having a lower vertebra contacting surface and an upper surface having a bearing surface thereon, wherein the upper and lower plates are configured to articulate with respect to one another; and a first notch in the lower surface of the upper plate and a second notch in the upper surface of the lower plate, wherein the first and second notches are aligned with one another. The placement instrument includes a handle and a rotatable key, wherein the key is configured to fit into the first and second notches. 
     In accordance with another embodiment of the invention, an intervertebral disc placement system includes an upper plate having an upper vertebra contacting surface and a lower surface having a bearing surface thereon; a lower plate having a lower vertebra contacting surface and an upper surface arranged to articulate with respect to the bearing surface of the upper plate; a first notch in the lower surface of the upper plate and a second notch in the upper surface of the lower plate, wherein the first and second notches are aligned with one another and face one another; and a placement instrument. The placement instrument has a handle and at least one movable key and the at least one key is configured to move into the first and second notches and retract toward the handle to secure the upper and lower plates to the placement instrument. 
     In accordance with a further embodiment of the invention, an intervertebral disc placement system includes an artificial disc and a placement instrument. The artificial disc comprises an upper plate having an upper vertebra contacting surface, a lower surface having an articulating surface thereon, anterior, posterior and two lateral edges; and a lower plate having a lower vertebra contacting surface, an upper articulating surface arranged to articulate with respect to the upper plate, anterior, posterior and two lateral edges. The placement instrument includes a handle and a disc receiving portion configured to receive the upper and lower plates of the artificial disc in the placement instrument in a locked configuration where the upper surface of the upper plate and the lower surface of the lower plate are angled such that the upper surface of the upper plate and the lower surface of the lower plate are closer together at an end of the disc remote from the placement instrument. 
     In accordance with an additional embodiment of the invention, an method of inserting an artificial disc into a space between two adjacent vertebrae includes the steps of: positioning the artificial disc on a placement instrument with upper and lower vertebrae contacting surfaces of the artificial disc positioned at an angle with respect to one another such that the vertebrae contacting surfaces are closer together at an end of the disc remote from the placement instrument; inserting the artificial disc partway into the space under constraint to prevent endplates of the prosthesis from articulating; releasing the prosthesis from constraint; and inserting the unconstrained prosthesis farther into the space. 
     Other features of the invention are set forth in the appended claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a bottom perspective view of a superior plate of an artificial disc; 
         FIG. 2  is a top perspective view of the plate of  FIG. 1 ; 
         FIG. 3  is a side cross sectional view of the superior plate taken along line  3 - 3  of  FIG. 1 ; 
         FIG. 4  is a top perspective view of an inferior plate of an artificial disc; 
         FIG. 5  is a bottom perspective view of the plate of  FIG. 2 ; 
         FIG. 6  is a side cross sectional view of the inferior plate taken along line  6 - 6  of  FIG. 4 ; 
         FIG. 7  is a perspective view of a core for use with the superior and inferior plates of  FIGS. 1 and 4 ; 
         FIG. 8  is a perspective view of the assembled intervertebral disc held by an placement instrument; 
         FIG. 9  is a perspective view of the placement instrument of  FIG. 8 ; 
         FIG. 10  is a top view of the placement instrument of  FIG. 9 ; 
         FIG. 11  is a side cross sectional view of the placement instrument taken along line  11 - 11  of  FIG. 10 ; 
         FIG. 12  is a top view of the placement instrument with a disc locking key in the unlocked position; and 
         FIG. 13  is a top view of the placement instrument with the key in the locked position. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     An intervertebral disc placement system according to the present invention includes a multi part disc and an associated placement instrument. The placement instrument holds the disc securely for placement into an intervertebral disc space and quickly releases the implant within the disc space. 
       FIGS. 1-3  illustrate a superior or upper plate  10  of an intervertebral disc.  FIGS. 4-6  illustrate a corresponding inferior or lower plate  20  and  FIG. 7  illustrates a core  30  positionable between the plates to form a complete articulating intervertebral disc. The upper and lower plates  10 ,  20  include outer vertebral body contacting surfaces which are provided with attachment enhancing features to ensure bone integration. The attachment enhancing features shown include one or more fins and an array of serrations. In the embodiment shown the upper plate includes two fins  12  and the lower plate includes one fin  22 . The fins  12 ,  22  can be an elongate fins pierced by one or more transverse holes  14  for bone ingrowth. The fins  12 ,  22  can have one or both ends formed at an angle, such as a 45 degree angle to aid in insertion of the fins into corresponding slots cut into the vertebral body. Particularly, the leading end of the fins  12 ,  22  should have an angled end surface. 
     The disc can be inserted laterally, from an anterior side, or from a posterior side. In the embodiment shown, the disc is designed for insertion laterally into an intervertebral space from either side. The lateral insertion of the disc is particularly useful in the lumbar spine where an anterior approach involves passing through the abdominal cavity and the posterior approach involve removal of a portion of the vertebra, such as the facets. Although the disc will be described herein as inserted laterally and is shown in a size appropriate for the lumbar spine, the system can be modified to accommodate other locations in the spine and other implantation approaches. 
     In the embodiment shown, two spaced apart superior fins  12  and a single central inferior fin  22  are provided on the upper and lower plates, respectively, extending in a lateral direction. Alternatively, one, two or more fins can be provided on either plate. In the example shown, the single fin is provided on one plate while the double fins are provided on the other plate to achieve a staggered arrangement particularly useful for multi-level disc implant procedures or in case an additional disc implant is required at a later time. The locations of the one and two fin plates can also be reversed so that the two fins are provided on the inferior plate. The orientation of the fin(s)  12 ,  22  can also be modified depending on the insertion direction for the intervertebral disc. 
     The fins  12 ,  22  are configured to be placed in slots in the vertebral bodies. The transverse holes  14  may be formed in any shape and may extend partially or all the way through the fins  12 ,  22 . Preferably, the fins  12 ,  22  each have a height greater than a width and have a length greater than the height. The fin length is preferably greater than one half of a dimension of the plate in the corresponding direction. 
     The fins  12 ,  22  provide improved attachment to the bone and prevent rotation of the plates in the bone. In some embodiments, the fins  12 ,  22  may extend from the surface of the plates  10 ,  20  at an angle other than 90°. For example on one or more of the plates  10 ,  20  where multiple fins  12 ,  22  are attached to the surface the fins may be canted away from one another with the bases slightly closer together than their edges at an angle such as about 80-88 degrees. The fins  12 ,  22  may have any other suitable configuration including various numbers, angles, serrated edges, and curvatures, in various embodiments. In some embodiments, the fins  12 ,  22  may be omitted altogether. 
     The intervertebral body contacting surfaces of the plates  10 ,  20  also can include other geometries of bone integration structures including serrations, teeth, grooves, ridges, pins, barbs or the like. When the bone integration structures are ridges, teeth, barbs or similar structures, they may be angled to ease insertion and prevent migration. These bone integration structures can be used to precisely cut the bone during implantation to cause bleeding bone and encourage bone integration. Additionally, the outer surfaces of the plates  10 ,  12  may be provided with a rough microfinish formed by blasting with aluminum oxide microparticles or the like to improve bone integration. In some embodiments, the outer surface may also be titanium plasma sprayed or HA (hydroxylapatite) coated to further enhance attachment of the outer surface to vertebral bone. 
     The intervertebral body contacting surfaces shown include a plurality of serrations  16 . The serrations  16  as shown are pyramid shaped serrations extending in mutually orthogonal directions, however, other shapes may also be used. The serrations have a height of about 0.5-1 mm and a width about equal to their height. With passage of time, firm connection between the plates  10 ,  20  and the vertebrae will be achieved as bone tissue grows over the serrated finish. Bone tissue growth will also take place about the fins  12 ,  22  and through the holes  14  therein, further enhancing the connection which is achieved. 
     Opposite the serrated vertebral body contacting surfaces of the plates  10 ,  20 , the plates have concave bearing surfaces  18 ,  28 . These concave bearing surfaces are shaped to accommodate and retain a mobile core. The particular shape and curvature of the bearing surfaces  18 ,  28  can vary to accommodate different shaped cores or different applications. Surrounding the bearing surfaces  18 ,  28  are angled surfaces  19 ,  29  which limit the articulation of the disc. The angle at which the surfaces  19 ,  29  are formed can be varied to form a disc with a selected maximum articulation. The maximum articulation can be different in each direction including the anterior, posterior and lateral directions. In one example, the disc is designed to allow angulations between the upper and lower plates of a maximum of ±12 degrees in the lateral direction, ±12 degrees in the anterior/posterior direction, and unlimited rotation. 
     The core  30 , as shown in  FIG. 7 , can be formed as a circular disc shaped member with upper and lower bearing surfaces  32  which match the curvature of the concave bearing surfaces  18 ,  28  of the plates. The core  30  also has one or more annular rims  34  which cooperate with a retention feature  40  on at least one of the plates  10 ,  20  to retain the core between the plates when the intervertebral disc is implanted between the vertebrae of a patient. The core  30  is moveable with respect to both the upper and lower plates  10 ,  20  to allow articulation, translation and rotation of the upper and lower plates with respect to one another. The core bearing surfaces  32  and concave bearing surfaces  18 ,  28  of the plates have the same radius of curvature which may vary depending on the size of the intervertebral disc. 
     The retention feature  40  in the illustrated embodiment comprises a retention ring  42  on the lower plate  20 , shown most clearly in  FIG. 6 . The retention ring  42  protrudes inwardly from an edge of the bearing surface  28 . Although a circumferential core retaining feature is shown, other core retaining features may also be used including at least those shown in U.S. Patent Publication Nos. 2005/0251262, 2005/0021146, and 2005/0021145, which are incorporated herein by reference in their entirety. 
     Although the core  30  has been shown as circular in cross section with spherically shaped bearing surfaces  32 , other shapes may be used including oval, elliptical, or kidney bean shaped. These non-circular shaped cores can be used to limit rotational motion between the upper and lower plates  10 ,  20 . The bearing surfaces  18 ,  28 ,  32  of the plates and core are shown as spherical, however flat, cylindrical, tab and groove, stepped or other shaped bearing surfaces may also be used. 
     Although the core  30  and plates  10 ,  20  have been shown as solid members, the core and plates may be made in multiple parts and/or of multiple materials. The core can be made of low friction materials, such as titanium, titanium nitrides, other titanium based alloys, tantalum, nickel titanium alloys, stainless steel, cobalt chrome alloys, ceramics, or biologically compatible polymer materials including PEEK, UHMWPE, PLA or fiber reinforced polymers. High friction coating materials can also be used. 
     The present invention has been illustrated as a three piece articulating disc with a mobile core. The invention may also be embodied in a two piece or ball and socket type disc which can be held by a placement instrument in the same manner described below with respect to the three piece disc. 
     The intervertebral disc according to the present invention provides articulation in two directions as well as translation and rotation. The plates  10 ,  20  are provided with notches  44  at one lateral end of each plate for use in grasping the disc by a placement instrument  50  shown in  FIG. 8 . The placement instrument facilitates holding and manipulation of the disc for insertion or removal of the disc in an intervertebral disc space. The notches  44  allow the plates  10 ,  20  to be grasped and inserted simultaneously in a locked orientation with or without a core  30  there between. The lateral edges of the plates  10 ,  20  also include a stepped surface  46 . On the end of the plates with the notches  22 , the stepped surfaces  46  engage a corresponding abutment surface on the placement instrument to further secure the plates in the placement instrument. 
     The upper and lower plates  10 ,  20  may be formed from titanium, titanium nitrides, other titanium based alloys, tantalum, nickel titanium alloys, stainless steel, cobalt chrome alloys, ceramics, or biologically compatible polymer materials including PEEK, UHMWPE, PLA or fiber reinforced polymers. The bearing surfaces or recesses  18 ,  28  are concavely, spherically curved and can have a hard coating such as a titanium nitride finish. The plates  10 ,  20  may be treated with aluminum oxide blasting followed by a titanium plasma spray to improve bone integration. Other materials and coatings can also be used such as titanium coated with titanium nitride, aluminum oxide blasting, HA (hydroxylapatite) coating, micro HA coating, and/or bone integration promoting coatings. Any other suitable metals or combinations of metals may be used as well as ceramic or polymer materials, and combinations thereof to optimize imaging characteristics. Any suitable technique may be used to couple materials together, such as snap fitting, slip fitting, lamination, interference fitting, use of adhesives, welding and/or the like. 
       FIG. 8  illustrates the plates  10 ,  20  secured in the placement instrument  50  and arranged with the upper plate at an angle with respect to the lower plate for placement of the disk. The angled placement orientation allows the plates  10 ,  20  to be inserted more easily into the intervertebral space with a narrow leading end formed by the angle of the plates. An angle between the upper vertebral body contacting surface of the upper plate  10  and the lower vertebral body contacting surface of the lower plate is at least 5 degrees. Preferably, the angle is about 15-30 degrees, and more preferably about 25 degrees. 
       FIG. 9  illustrates the disc holding end of the placement instrument  50  is mounted on a shaft  60 . The instrument  50  includes a pair of arms  52  having flat surfaces on opposite top and bottom sides for supporting the plates interior surfaces. An abutment surface  54  overhangs a groove  56  which is configured to receive the protruding stepped surface at the ends of the  46  of the plates. A rotatable key  58  functions as a locking mechanism and is received in the notches  44  of the plates. The engagement of the rotatable key  58  in the notches  44  allows the plates  10 ,  20  to be made without any outwardly extending engagement features. This can provide an advantage of a lower profile over many of the know devices having exterior rims or grooves for engagement by a placement instrument. The key engagement system of the placement instrument also provides the advantage of a narrower placement profile than those placement instruments which grasp the side surfaces of a disc. 
       FIGS. 12 and 13  show the operation of the handle end of the placement instrument  50  which includes the handle  62 , a rotatable knob  64 , and a movable lever  66 . The movable lever  66  is connected through a central shaft  68  of the handle (shown in  FIG. 11 ) to the key  58  and functions as a key rotating mechanism to move the key from an unlocked position shown in  FIG. 12  to a locked position shown in  FIG. 13 . The rotatable knob  64  functions as a retraction mechanism to retract the key  58  toward the handle  62  to secure the plates against the abutment surfaces  54 . In operation, the plates  10 ,  20  are place in the disc holding end of the placement instrument with the notches  44  aligned over the key  58  and the key in the unlocked position of  FIG. 12 . The key  58  is then rotated 90 degrees by moving the lever  66  90 degrees causing the ends of the key to enter the notches  44 . The plates  10 ,  20  are then pulled tight against the abutment surfaces  54  of the instrument by rotating the knob  64  to retract the key toward the handle. This pulls the key  58  against the side of the notches  44  to lock the plates tightly in place. 
     The disc holding end of the placement instrument  50  can be marked, such as by markers  70  which include either two dots or one dot indicating that the position for either a two fin or one fin plate. Other marking or indicia can also be used to identify the correct location and/or orientation of the plates, such as labeling (superior, inferior), color coding, or other insignia. 
     The artificial intervertebral disc is surgically implanted between adjacent spinal vertebrae in place of a damaged disc. Those skilled in the art will understand that the damaged disc is partially or totally removed according to known procedures and the adjacent vertebrae are forcibly separated from one another to provide the necessary space for insertion of the disc. The plates  10 ,  20  are slipped into place between the vertebrae with their fins  12 ,  22  entering slots cut in the opposing vertebral surfaces to receive them. The plates  10 ,  20  may be inserted simultaneously with or without the core  30 . The disc may be inserted all the way to a final resting place with the placement instrument  50 , or after partial insertion of the disc, the individual plates  10 ,  20  can be further advanced independently or together to a final position. The insertion of the disc partway into the intervertebral space while connected to the placement instrument and then the further insertion of the plates while they are free to move with respect to one another allows the disc to moved to a final position while it is free to take on the angulation or lordosis of the space. This reduces the problem of overdistraction of the disc space. 
     Once the disc has been partially or completely inserted, the placement instrument  50  is removed from the plates  10 ,  20  by simply rotating the lever  66  90 degrees back to the unlocked position of the key  58 . Once the disc has been inserted, the vertebra move together to hold the assembled disc in place. 
     The vertebral contacting surfaces of the plates  10 ,  20  including the serrations  16  locate against the opposing vertebrae and, with passage of time, firm connection between the plates and the vertebrae will be achieved as bone tissue grows over the serrated finish. Bone tissue growth will also take place about the fins  12 ,  22  and through the holes  14  therein, further enhancing the connection which is achieved. 
     While the exemplary embodiments have been described in some detail, by way of example and for clarity of understanding, those of skill in the art will recognize that a variety of modifications, adaptations, and changes may be employed. Hence, the scope of the present invention should be limited solely by the appended claims.