Spinous Process Fusion Implants and Insertion, Compression, and Locking Instrumentation

Abstract

A bone plate assembly including at least one bone plate, polyaxially adjustable fixation elements and a polyaxially adjustable locking mechanism. A first plate includes at least one polyaxial element for lockable connection with a fixation pad, and a connection feature which allows the plate to translate and polyaxially rotate relative to the locking mechanism. A second plate includes at least one polyaxial element for connection with a fixation pad and a connection feature for non-rotatable connection with the locking mechanism. The locking mechanism allows translation and polyaxial adjustment of the first plate relative to the second plate and locks the first and second plates via a taper lock. The fixation pad includes a deflectable spacer configured to prevent premature locking of the pad. Methods for implantation of the bone plate assembly between bone structures are disclosed. Instrumentation for implantation, compression and locking of the bone plate assembly is disclosed.

1 - 20 . (canceled) 
     
     
         21 . A device, comprising:
 a primary instrument configured to insert and lock an implant having a first portion, a second portion opposite the first portion, and a locking mechanism coupling the first portion to the second portion;   wherein the primary instrument is configured to transition the implant from an insertion configuration, a clamped configuration, and a first locked configuration;   wherein, in the insertion configuration, the primary instrument holds the first portion apart from the second portion;   wherein the primary instrument is configured to urge the first portion toward the second portion to change the system from the insertion configuration to the clamped configuration, wherein the primary instrument permits the first portion to polyaxially rotate relative to the second portion as the first portion is urged toward the second portion;   wherein, in the clamped configuration, the primary instrument holds the first portion fixed relative to the second portion;   wherein the primary instrument is configured to urge at least a first component of the locking mechanism from an unlocked position to a first locked position to change the system from the clamped configuration to the first locked configuration, wherein the primary instrument maintains the first portion fixed relative to the second portion as the first component is urged from the unlocked position to the first locked position.   
     
     
         22 . The system of  claim 21 , wherein the primary instrument comprises first and second opposing jaws, wherein the first jaw is pivotable relative to the second jaw about first and second axes, wherein the second axis is perpendicular to the first axis, wherein the first jaw holds the first portion, wherein the first portion is pivotable relative to the first jaw about a third axis, wherein the third axis is perpendicular to the second axis, wherein the second jaw holds the second portion, wherein the second portion is pivotable relative to the second jaw about a fourth axis, wherein the fourth axis is parallel to the first axis. 
     
     
         23 . The system of  claim 21 , wherein the primary instrument comprises a force indicator, wherein the force indicator indicates when a predetermined locking force has been applied by the primary instrument to urge the first component from the unlocked position to the first locked position. 
     
     
         24 . The system of  claim 21 , wherein the primary instrument avoids contact with the locking mechanism in the insertion configuration and the clamped configuration, wherein the primary instrument contacts at least the first component in the first locked configuration. 
     
     
         25 . The system of  claim 21 , wherein the primary instrument comprises a selector;
 wherein, in the insertion and clamped configurations, the selector is in a first position;   wherein, in the first locked configuration, the selector is in a second position;   wherein, when the selector is in the first position, the system is prevented from changing to the first locked configuration;   wherein, when the selector is in the second position, the system is permitted to change to the first locked configuration.   
     
     
         26 . The system of  claim 21 , comprising:
 a secondary instrument;   wherein the system has a second locked configuration;   wherein the secondary instrument urges at least a second component of the locking mechanism from an unlocked position to a second locked position to change the system from the first locked configuration to the second locked configuration, wherein the secondary instrument avoids contact with the first and second portions as the second component is urged from the unlocked position to the second locked position;   wherein, in the second locked configuration, the first and second components of the locking mechanism maintain the first portion fixed relative to the second portion.   
     
     
         27 . The system of  claim 26 , wherein the secondary instrument comprises a force indicator, wherein the force indicator indicates when a predetermined locking force has been applied by the secondary instrument to urge the second component from the unlocked position to the locked position. 
     
     
         28 . A system, comprising:
 a primary instrument releasably securable to an implant having first and second plates coupled together by a locking mechanism, wherein the second plate faces the first plate, wherein the primary instrument comprises rigid, lock, and pivot jaws hinged together at a main pivot element so that each jaw is independently rotatable relative to the other jaws about a center longitudinal axis of the pivot element, wherein the rigid jaw faces the lock and pivot jaws, wherein the lock jaw is releasably fixed to the pivot jaw, wherein the pivot jaw is releasably connected to the rigid jaw, wherein the connection permits one way motion of the pivot jaw toward the rigid jaw, wherein the pivot jaw is rotatable relative to the rigid and lock jaws about a second axis, wherein the second axis forms a non-zero angle with the center longitudinal axis;   wherein the primary instrument picks up, inserts, compresses, and locks the implant while remaining continuously secured to the implant.   
     
     
         29 . The system of  claim 28 , wherein the first plate is releasably securable to the pivot jaw and the second plate is releasably securable to the rigid jaw. 
     
     
         30 . The system of  claim 29 , wherein the first plate and second plate each comprise cup shaped pockets, wherein the pivot jaw and the rigid jaw each comprise spherical tips, wherein the cup shaped pockets releasably receive the spherical tips, wherein the cup shaped pockets are pivotable on the spherical tips. 
     
     
         31 . The system of  claim 28 , comprising:
 a caddy, wherein the caddy supports the implant with the first plate separated from the second plate;   wherein the primary instrument is releasably securable to the implant while the implant is supported by the caddy;   wherein the primary instrument picks the implant up out of the caddy after the primary instrument is releasably secured to the implant.   
     
     
         32 . The system of  claim 28 , wherein the primary instrument holds the first plate separated from the second plate while the implant is inserted into an implantation site. 
     
     
         33 . The system of  claim 28 , wherein the lock jaw applies no compressive force to the implant when the lock jaw is releasably fixed to the pivot jaw while the primary instrument compresses the first and second plates together. 
     
     
         34 . The system of  claim 28 , wherein the lock jaw applies a compressive force to the implant when the lock jaw is released from the pivot jaw while the primary instrument locks the first and second plates together. 
     
     
         35 . An insertion, compression, and locking instrument, comprising:
 a rigid leg, wherein the rigid leg comprises a handle portion and a tip portion opposite the handle portion;   a lock leg, wherein the lock leg comprises a handle portion and a tip portion opposite the handle portion;   a pivot leg, wherein the pivot leg comprises a rear portion and a tip portion opposite the rear portion, wherein the pivot leg tip portion swivels relative to the pivot leg rear portion, wherein the rigid leg, the lock leg, and the pivot leg are pivotally attached together, wherein the rigid leg tip portion faces the lock leg tip portion and the pivot leg tip portion; and   a selector, wherein, when the selector is in a first position, the lock leg and the pivot leg pivot as one relative to the rigid leg, wherein, when the selector is in a second position, the lock leg and the pivot leg pivot separately relative to the rigid leg.   
     
     
         36 . The instrument of  claim 35 , wherein the rigid leg tip portion comprises a pair of spherical protrusions, wherein the pivot leg tip portion comprises a pair of spherical protrusions, wherein the rigid leg protrusions face the pivot leg protrusions. 
     
     
         37 . The instrument of  claim 35 , wherein the rigid leg comprises a central slot, wherein at least a portion of the pivot leg is within the rigid leg slot, wherein the pivot leg comprises a central slot, wherein at least a portion of the rigid leg is within the pivot leg slot. 
     
     
         38 . The instrument of  claim 35 , wherein the instrument comprises a force indicator, wherein the force indicator indicates when a predetermined force has been applied between the rigid leg tip portion and the lock leg tip portion. 
     
     
         39 . The instrument of  claim 35 , wherein the pivot leg is releasably connectable to the rigid leg, wherein, when the pivot leg is connected to the rigid leg, the pivot leg tip portion can move toward the rigid leg tip portion and the pivot leg tip portion is prevented from moving away from the rigid leg tip portion. 
     
     
         40 . The instrument of  claim 35 , wherein the instrument comprises:
 a first configuration, in which the selector is in the first position, the rigid leg tip portion is at a first distance from the lock leg tip portion, and the lock leg tip portion is at an initial distance from the pivot leg tip portion;   a second configuration, in which the selector is in the first position, the rigid leg tip portion is at a second distance from the lock leg tip portion, and the lock leg tip portion is at the initial distance from the pivot leg tip portion, wherein the second distance is less than the first distance; and   a third configuration, in which the selector is in the second position, the rigid leg tip portion is at a third distance from the lock leg tip portion, and the lock leg tip portion is at a final distance from the pivot leg tip portion, wherein the third distance is less than the second distance, wherein the final distance is greater than the initial distance.