Intrabody Osteotomy Implant and Methods of Use

Abstract

Methods for surgically adjusting a curvature of a spine are disclosed. The methods provide for controlling the alignment of bony structures, such as vertebral bodies or portions thereof, as they are moved relative to one another during a surgical procedure. An intrabody implant disclosed and methods of use are also disclosed. The implant has an inclined surface, forming a wedge or other shape having, for example, an acute angle adapted to be placed between at least two separated portions of a single bony structure (such as a vertebral body). In some embodiments, the implant may be used to support portions of a vertebral body that have been separated surgically as part of a pedicle subtraction osteotomy and to orient the portions at a more predictable lordotic angle.

1 . (canceled) 
     
     
         2 . A system comprising:
 an intrabody implant adapted to be placed between at least two separated portions of a single bony structure, the intrabody implant comprising:
 a first surface configured for engaging a first vertebra, 
 a second surface opposite the first surface configured for engaging a second vertebra, and 
 a wall disposed from the first surface to the second surface, the wall comprising extending along a longitudinal axis between an anterior portion and a posterior portion, the posterior portion having a maximum height that is less than a maximum height of the anterior portion, the posterior portion of the wall comprising an outer concave surface, the anterior portion of the wall comprising an outer convex surface, the posterior portion of the wall defining a convex profile from the first surface to the second surface, the posterior portion comprising a threaded bore that extends parallel to the longitudinal axis through opposite inner and outer surfaces of the wall such that the bore is positioned between the first and second surfaces, 
   a first and a second pedicle screw each comprising at least one head, and a third and a fourth pedicle screw each comprising at least one head, wherein each head comprises spaced apart arms that define a U-shaped implant cavity therebetween configured for disposal of a rod, and   a first rod configured to connect the first and second pedicle screws; and   a second rod configured to connect the first, second, third, and fourth pedicle screws.   
     
     
         3 . The system as recited in  claim 1 , wherein the first and second surfaces of the intrabody implant comprise columns of teeth, adjacent columns being spaced apart from one another by a gap that extends parallel to the longitudinal axis, the teeth each having a substantially right-triangular profile, the teeth being sloped upwards toward the anterior portion. 
     
     
         4 . The system as recited in  claim 1 , wherein the first and second surfaces of the intrabody implant define an aperture extending through the implant to allow for bone growth through the implant from the first portion of the bony structure to the second portion of the bony structure. 
     
     
         5 . The system as recited in  claim 1 , wherein the second surface of the intrabody implant is disposed at an acute angle relative to the first surface of the intrabody implant. 
     
     
         6 . The system as recited in  claim 4 , wherein the posterior height is less than the anterior height such that the acute angle of the intrabody implant introduces a lordotic angle between the first and second portions of the bony structure. 
     
     
         7 . The system as recited in  claim 5 , wherein:
 the posterior portion of the wall of the intrabody implant comprises an outer concave surface configured to conform to a posterior anatomy of the bony structure; and   the anterior portion of the wall of the intrabody implant comprises an outer convex surface configured to conform to an anterior anatomy of the bony structure.   
     
     
         8 . The system as recited in  claim 6 , wherein the teeth each have a substantially right-triangular profile, the teeth being sloped upwards toward the anterior portion. 
     
     
         9 . The system as recited in  claim 4 , wherein the acute angle is between 10 degrees and 30 degrees. 
     
     
         10 . The system as recited in  claim 8 , wherein the acute angle is between 15 degrees and 25 degrees. 
     
     
         11 . The system as recited in  claim 1 , wherein the intrabody implant includes a width extending parallel to the anterior portion and the posterior portion, the width being at least 40 mm. 
     
     
         12 . The system as recited in  claim 1 , wherein the first and second pedicle screws are dual headed screws and the first rod is configured to connect a first head of the first pedicle screw with a first head of the second pedicle screw. 
     
     
         13 . The system as recited in  claim 11 , wherein the second rod is configured to connect a second head of the first pedicle screw with a second head of the second pedicle screw. 
     
     
         14 . The system as recited in  claim 1 , wherein the intrabody implant is formed entirely of PEEK polymer. 
     
     
         15 . The system as recited in  claim 13 , wherein the intrabody implant further comprises a coating of titanium applied to the first and second surfaces. 
     
     
         16 . The system as recited in  claim 1 , wherein the intrabody implant is formed entirely of bone material. 
     
     
         17 . The system as recited in  claim 1 , wherein the wall of the intrabody implant has no projections or surface features. 
     
     
         18 . The system as recited in  claim 16 , wherein the intrabody implant comprises a coating applied to one or more of the first and second surfaces and the wall to encourage bone growth onto the intrabody implant, the coating comprising a material selected from a group consisting of gold, titanium, hydroxyapatite and combinations thereof. 
     
     
         19 . The system as recited in  claim 17 , wherein the intrabody implant comprises a coating applied to one or more of the first and second surfaces and the wall to encourage bone growth onto the implant. 
     
     
         20 . A kit comprising:
 an intrabody implant adapted to be placed between at least two separated portions of a single bony structure, the intrabody implant comprising:
 a first surface configured for engaging a first vertebra, 
 a second surface opposite the first surface configured for engaging a second vertebra, and 
 a wall disposed from the first surface to the second surface, the wall comprising extending along a longitudinal axis between an anterior portion and a posterior portion, the posterior portion having a maximum height that is less than a maximum height of the anterior portion, the posterior portion of the wall comprising an outer concave surface, the anterior portion of the wall comprising an outer convex surface, the posterior portion of the wall defining a convex profile from the first surface to the second surface, the posterior portion comprising a threaded bore that extends parallel to the longitudinal axis through opposite inner and outer surfaces of the wall such that the bore is positioned between the first and second surfaces, wherein the first and second surfaces implant comprise columns of teeth, adjacent columns being spaced apart from one another by a gap that extends parallel to the longitudinal axis, the teeth each having a substantially right-triangular profile, the teeth being sloped upwards toward the anterior portion; 
   a first and a second dual-headed pedicle screw each comprising a first head and a second head, and a third and a fourth single headed pedicle screw each comprising one head, wherein each head comprises spaced apart arms that define a U-shaped implant cavity therebetween configured for disposal of a rod, and   a first rod configured to connect the first and second pedicle screws using the first head of each of the first and second dual-headed pedicle screws; and   a second rod configured to connect the first, second, third, and fourth pedicle screw using the second head of each of the first and second dual-headed pedicle screws and the one head of each of the third and fourth single headed pedicle screws.   
     
     
         21 . A kit comprising:
 an intrabody implant adapted to be placed between at least two separated portions of a single bony structure, the intrabody implant comprising:
 a first surface configured for engaging a first vertebra, 
 a second surface opposite the first surface configured for engaging a second vertebra, wherein the second surface is disposed at an acute angle relative to the first surface, and 
 a wall disposed from the first surface to the second surface, the wall comprising extending along a longitudinal axis between an anterior portion and a posterior portion, the posterior portion having a maximum height that is less than a maximum height of the anterior portion, the posterior portion of the wall comprising an outer concave surface, the anterior portion of the wall comprising an outer convex surface, the posterior portion of the wall defining a convex profile from the first surface to the second surface, the posterior portion comprising a threaded bore that extends parallel to the longitudinal axis through opposite inner and outer surfaces of the wall such that the bore is positioned between the first and second surfaces; 
   a first and a second dual-headed pedicle screw each comprising a first head and a second head, and a third and a fourth single headed pedicle screw each comprising at least one head, wherein each head comprises spaced apart arms that define a U-shaped implant cavity therebetween configured for disposal of a rod, and   a first rod configured to connect the first and second pedicle screws using the first head of each of the first and second dual-headed pedicle screws; and   a second rod configured to connect the first, second, third, and fourth pedicle screw using the second head of each of the first and second dual-headed pedicle screws and one head of each of the third and fourth single headed pedicle screws.