Patent Publication Number: US-10786363-B2

Title: Spacerless artificial disc replacements

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation of U.S. application Ser. No. 14/921,409 (“the &#39;409 Application), filed Oct. 23, 2015, which is a continuation of Ser. No. 14/169,657 (“the &#39;657 Application”), filed Jan. 31, 2014 and now U.S. Pat. No. 9,198,773, which is a continuation of U.S. application Ser. No. 13/597,898 (“the &#39;898 Application”), filed Aug. 29, 2012 and now U.S. Pat. No. 8,679,182, which is a continuation of U.S. application Ser. No. 12/789,925 (“the &#39;925 Application”), filed May 28, 2010 and now U.S. Pat. No. 8,277,507, which is a continuation of U.S. application Ser. No. 11/194,786 (“the &#39;786 Application”), filed Aug. 1, 2005, which is a continuation of U.S. application Ser. No. 10/413,028 (“the &#39;028 Application”), filed Apr. 14, 2003, each of said applications also claiming the benefit of the filing date of U.S. Provisional Patent Application No. 60/372,520, filed Apr. 12, 2002, the disclosures of all said applications being hereby incorporated herein by reference. The present application and the &#39;657, &#39;898, &#39;925, &#39;786, and &#39;028 Applications also claim the benefit of the filing date of U.S. Provisional Patent Application No. 60/449,642, filed Feb. 24, 2003. 
    
    
     FIELD OF THE INVENTION 
     This invention relates generally to artificial disc replacements (ADRs) and, more particularly, to devices that operate without softer spacer materials such as polyethylene. 
     BACKGROUND OF THE INVENTION 
     Polyethylene spacers are common in some artificial joint situations, including total knee replacements (TKRs). Polyethylene spacers are also used between metal plates in many artificial disc replacement (ADR) designs. 
     Complications arising from poly debris are well documented, however, including fracture of the spacer once it becomes too thin, absorptions and migration of poly particles throughout the body, and loosening of the bone metal junction as a reaction of the poly debris. 
     Metal-on-metal and ceramic-on-metal surfaces have much lower wear characteristics. In fact, metal-on-metal surfaces demonstrate 400 times less wear than polyethylene on metal surfaces. 
     While there have been attempts to limit the use of the poly in ADR designs, all existing approaches constitute call-and-socket configurations which do not inherently limit axial rotation. Instead, axial rotation is limited through the use of multiple ball-and-socket joints or an elongated ball-and-socket joint, which complicates the design. 
     SUMMARY OF THE INVENTION 
     The present invention replaces polyethylene artificial disc replacement (ADR) spacers with harder, more wear resistant materials. In the preferred embodiments, an ADR according to the invention includes opposing saddle-shaped components to facilitate more normal spinal flexion, extension, and lateral bending. Preferably, the ADR allows at least 10 degrees of movement on the flexion to extension direction and at least 5 degrees of movement in the lateral bending direction. The saddle-shaped articulating surfaces also limit axial rotation, thereby protecting the facet joints and the annulus fibrosis (AF). 
     According to the invention, either or both the superior and inferior components are made of a hard material such as chrome cobalt, titanium, or a ceramic including alumina, zirconia, or calcium phosphate. The articulating surfaces of the ADR are also preferably highly polished to reduce friction between the components. Metals, alloys or other materials with shape-memory characteristics may also prove beneficial. 
     The vertebral surfaces of the components may be treated to promote bone ingrowth. For example, the vertebral surfaces of the components may have plasma spray or beads. Alternatively, one or both components may be cemented to the vertebrae. The vertebra-facing surfaces may also include projections such as keels that fit into the vertebrae. In embodiments adapted for cementation, one of the components could be made of polyethylene or other softer material. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1A  is an anterior view of an ADR according to the invention; 
         FIG. 1B  is a lateral view of the ADR of  FIG. 1 ; 
         FIG. 1C  is an oblique view of the ADR of  FIG. 1 ; 
         FIG. 1D  is a lateral view of the ADR of  FIG. 1  representing a center of rotation defined by an articular surface of the ADR. 
         FIG. 1E  is an anterior view of the ADR of  FIG. 1  representing another center of rotation defined by another articular surface of the ADR. 
         FIG. 2A  is a view of the anterior aspect of an alternative embodiment of the ADR; 
         FIG. 2B  is a view of the lateral aspect of an alternative embodiment of the ADR shown in  FIG. 2B ; 
         FIG. 3A  is a view of the anterior aspect of an alternative, less constrained, embodiment of the saddle-shaped ADR shown in a fully flexed position; 
         FIG. 3B  is a view of the lateral aspect of the embodiment of the ADR shown in  FIG. 3A ; 
         FIG. 4A  is a view of the lateral aspect of another embodiment of a saddle-shaped ADR; 
         FIG. 4B  is a view of the anterior aspect of the embodiment of the ADR shown in  FIG. 4A  in a fully flexed position; 
         FIG. 4C  is a view of the anterior aspect of an alternative embodiment; 
         FIG. 4D  is a view of the anterior aspect of the ADR shown in  FIG. 4A ; and 
         FIG. 4E  is a view of the anterior aspect of the ADR shown in  FIG. 4A . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       FIG. 1A  is an anterior view of an ADR according to the invention.  FIG. 1B  is a lateral view of the ADR of  FIG. 1 .  FIG. 1C  is an oblique view of the ADR of  FIG. 1 . 
       FIG. 2A  is a view of the anterior aspect of an alternative embodiment of the ADR, wherein the articulating surfaces of both components have a flat area centrally from the front to the back of the ADR.  FIG. 2B  is a view of the lateral aspect of an alternative embodiment of the ADR drawn in  FIG. 2B . The flat area of the articulating surfaces courses centrally from side of the DR to the other side. The flat area allows one component to translate slightly on the other component. Alternatively, a curved area with a large radius could replace the flat area. 
       FIG. 3A  is a view of the anterior aspect of an alternative, less constrained, embodiment of the saddle-shaped ADR drawn in a fully flexed position. The less constrained embodiment facilitates spinal flexion, extension, and lateral bending.  FIG. 3B  is a view of the lateral aspect of the embodiment of the ADR drawn in  FIG. 3A . 
       FIG. 4A  is a view of the lateral aspect of another embodiment of a saddle-shaped ADR. The center of rotation for flexion and extension is not necessarily located in the center of the ADR. For example, the center of rotation is preferably located in the posterior half of the ADR.  FIG. 4B  is a view of the anterior aspect of the embodiment of the ADR drawn in  FIG. 4A , drawn in a fully flexed position. 
       FIG. 4C  is a view of the anterior aspect of an alternative embodiment, showing how the radius of curvature of the articulation for lateral bending may be different than the radius of curvature for articulation for flexion and extension. For example, the radius of curvature for the articulation for flexion and extension, as seen in  FIG. 4A , may be smaller than the radius of curvature for the articulation for lateral bending, as seen in  FIG. 4C . Articulating surfaces with smaller radii, facilitate movement. Thus, the embodiment of the ADR drawn in  FIG. 4A  flexes and extends more easily than the embodiment of the ADR drawn in  FIG. 3A . The ADR is drawn in a fully flexed position. 
       FIG. 4D  is a view of the anterior aspect of the ADR drawn in  FIG. 4A . The ADR is drawn in a neutral position. The area of the drawing with diagonal lines represents the articulating surface of the lower ADR component.  FIG. 4E  is a view of the anterior aspect of the ADR drawn in  FIG. 4A , also drawn in a fully extend position.