BONE FIXATION ELEMENT
A bone fixation element ( 10 ) for use in spinal fixation facilitates insertion of a longitudinal spinal rod ( 45 ) in a rod-receiving channel ( 26 ) formed in the bone fixation element. The bone fixation element engages a coated spinal rod, preferably a dynamic spinal rod made from a generally non-biocompatible material such as nickel, cobalt chromium or Nitinol. The bone fixation element preferably incorporates first ( 120 ) and second ( 140 ) rod protectors to contact the coating on the spinal rod when the rod is received in the rod receiving channel of the hone fixation element. The first and second rod protectors are preferably constructed of a material having a hardness that is less than a hardness of a material of the coated spinal rod.
1 - 22 . (canceled)
23 . A bone fixation system for mounting to vertebrae, the bone fixation system comprising:
a coated, spinal rod; and
at least two bone fixation elements, each bone fixation element comprising:
a bone anchor;
a body portion having an inner bore and a rod-receiving channel dimensioned to receive the coated spinal rod;
a first rod protector dimensioned to fit within the inner bore of the body portion, the first rod protector having a top surface for contacting the coated spinal rod;
a second rod protector dimensioned to fit within the inner bore of the body, the second rod protector having a bottom surface for contacting the coated spinal rod; and
a closure cap configured to engage the body portion for at least partially obstructing the rod receiving channel to secure the coated spinal rod in the rod-receiving channel of the body portion, wherein the first and second rod protectors are constructed of a material having a hardness less than a hardness of a material of the coated spinal rod;
wherein the first and second rod protectors are manufactured from a material selected from the group consisting of polyetheretherketone (PEEK), polyetherketoneketone (PEKK), polyaryletherketone (PEAK), polytetrafluoroethylene (PTFE), ultra-high molecular weight polyethylene (UHMWPE), poly lactic acid (PLA), and polyurtethan urea (PUUR).
24 . The bone fixation system of claim 23 , wherein the coated spinal rod is a dynamic spinal rod such that the rod is bendable to facilitate movement of adjacent vertebrae.
25 . The bone fixation system of claim 24 , wherein at least a portion of the coated spinal rod includes a reduced diameter portion
26 . The bone fixation system of claim 23 , wherein the coated spinal rod is made from a non-biocompatible material.
27 . The bone fixation system of claim 26 , wherein the material of the coated spinal rod is selected from the group consisting of Nitinol, a Nitinol alloy, cobalt chromium, a cobalt chromium alloy, stainless steel, and a shape memory alloy.
28 . The bone fixation system of claim 26 , wherein the material of the coated spinal rod is selected from the group consisting of nickel and a nickel alloy.
29 . The bone fixation system of claim 23 , wherein the material of the coated spinal rod is constructed of Nitinol or a member of the Nitinol family and the material of the first and second rod protectors has a hardness of 0-430 HV 0.5.
30 . The bone fixation system of claim 23 , wherein the material of the coated spinal rod is constructed of a Nitinol or a member of the Nitinol family and the material of the first and second rod protectors has a hardness of 0-380 HV 0.5.
31 . The bone fixation system of claim 23 , wherein the material of the coated spinal rod is constructed of a cobalt chromium or a cobalt chromium alloy and the material of the first and second rod protectors has a hardness of 0-420 HV 0.5.
32 . The bone fixation system of claim 23 , wherein the material of the coated spinal rod is constructed of a cobalt chromium or a cobalt chromium alloy and the material of the first and second rod protectors has a hardness of 0-400 HV 0.5.
33 . The bone fixation system of claim 23 , wherein the bone anchor is poly-axially rotatable with respect to the body portion.
34 . The bone fixation system of claim 33 , wherein the first rod protector is disposed between an enlarged head portion of the bone anchor and the coated spinal rod when the spinal rod is received within the rod receiving channel and the second rod protector is disposed between the closure cap and the coated spinal rod when the spinal rod is received within the rod receiving channel and the closure cap engages the body portion.
35 . The bone fixation system of claim 33 , wherein the first and second rod protectors are configured to substantially surround the coated spinal rod once the closure cap is engaged with the body portion.
36 . The bone fixation system of claim 23 , wherein the material of the first and second rod protectors has a hardness A and the material of the coated spinal rod has a hardness B, the hardness A being less than the hardness B.
37 . The bone fixation system of claim 36 , wherein the first and second rod protectors are configured to deform about the spinal rod as the closure cap is engaged to the body portion.
38 . The bone fixation system of claim 37 , wherein the top surface of the first rod protector and the bottom surface of the second rod protector include a saddle having a radius of curvate configured to substantially correspond with a radius of curvature of the coated spinal rod.
39 . A bone fixation system for mounting to vertebrae, the bone fixation system comprising:
a coated, spinal rod; and
at least two bone fixation elements, each bone fixation element comprising:
a bone anchor;
a body portion having an inner bore and a rod-receiving channel dimensioned to receive the coated spinal rod;
a first rod protector dimensioned to fit within the inner bore of the body portion, the first rod protector having a top surface for contacting the coated spinal rod;
a second rod protector dimensioned to fit within the inner bore of the body, the second rod protector having a bottom surface for contacting the coated spinal rod; and
a closure cap configured to engage the body portion for at least partially obstructing the rod receiving channel to secure the coated spinal rod in the rod-receiving channel of the body portion, wherein the first and second rod protectors are constructed of a material having a hardness less than a hardness of a material of the coated spinal rod;
wherein the first and second rod protectors are manufactured from a material having a hardness A and the spinal rod is manufactured from a material having a hardness B, the hardness A of the first and second rod protectors being less than the hardness B of the spinal rod.
40 . The bone fixation system of claim 39 , wherein the material of the coated spinal rod is constructed of Nitinol or a member of the Nitinol family and the material of the first and second rod protectors has a hardness of 0-430 HV 0.5.
41 . The bone fixation system of claim 39 , wherein the material of the coated spinal rod is constructed of a Nitinol or a member of the Nitinol family and the material of the first and second rod protectors has a hardness of 0-380 HV 0.5.
42 . The bone fixation system of claim 39 , wherein the material of the coated spinal rod is constructed of a cobalt chromium or a cobalt chromium alloy and the material of the first and second rod protectors has a hardness of 0-420 HV 0.5.
43 . The bone fixation system of claim 39 , wherein the material of the coated spinal rod is constructed of a cobalt chromium or a cobalt chromium alloy and the material of the first and second rod protectors has a hardness of 0-400 HV 0.5.