Spinal fixation system and kit
A spinal fixation system includes an expandable disc replacement body and an angle-setting disc replacement holder; The expandable disc replacement body includes a first wall, a second wall, and a hinge connecting the first wall and the second wall. An insertion instrument may be used to implant the expandable disc replacement body into a subject. The disc replacement holder is positioned between the first wall and the second wall, and an angle and/or height between the first wall and the second wall can be varied by adjustment of the disc replacement holder and locked into place using locking mechanisms.
1 . A kit for a spinal fixation system comprising:
(i) an expandable disc replacement body including a first wall, a second wall, a hinge connecting the first wall and the second wall, and a locking mechanism including a first arm coupled to the first wall, a second arm coupled to the second wall, and a first locking wall, wherein the first arm, second arm, and first locking wall are positioned between the first wall and the second wall,
(ii) an anterior plate configured to provide fixation for the expandable disc replacement body in a subject; and
(iii) an angle adjustment instrument, wherein an angle between the first wall and the second wall is adjusted with the angle adjustment instrument, and the angle can be locked in place at a time of implantation in the subject,
wherein opposite surfaces of the first arm engage the first arm between the second arm and the first locking wall to lock the angle in place.
2 . The kit of claim 1 wherein the angle adjustment instrument includes a lever arm and a fulcrum for expanding the expandable disc replacement body.
3 . The kit of claim 2 , wherein the angle is continuously varied between a lower value of the angle and an upper value of the angle by movement of the angle adjustment instrument.
4 . The kit of claim 2 , wherein the angle adjustment instrument includes:
a ratcheting mechanism to provide tactile feedback to a user regarding an amount of expansion of the expandable disc replacement body.
5 . The kit of claim 4 , wherein the angle adjustment instrument is configured to adjust the angle to a higher angle as bone graft is pushed into the space in the expandable disc replacement body, and
wherein the angle adjustment instrument reduces the angle to a lower angle after the bone graft introducer is removed.
6 . The kit of claim 4 , wherein the ratcheting mechanism provides for 1 degree increments for the amount of expansion of the expandable disc replacement body.
7 . The kit of claim 1 , wherein the locking mechanism includes:
flexing the second arm to engage the first arm between the second arm and the first locking wall.
8 . The kit of claim 7 , wherein the hinge includes a threaded portion for receiving the locking screw.
9 . The kit of claim 1 , further comprising a second locking mechanism including:
a third arm coupled to the first wall,
a fourth arm coupled to the second wall, and
a second locking wall,
wherein the third arm, fourth arm, and second locking wall are positioned between the first wall and the second wall.
10 . The kit of claim 9 , wherein the second locking mechanism includes:
flexing the fourth arm to engage the third arm between the fourth arm and the second locking wall.
11 . The kit of claim 1 , wherein the spinal fixation system includes a surface treatment, and wherein the surface treatment includes at least one of a plasma coating, 3-D pores, a hydroxyapatite coating, metal abrasion, or metal pits.
12 . The kit of claim 1 , further comprising an insertion instrument configured to insert the expandable disc replacement body into a spine of the subject.
13 . The kit of claim 12 , wherein at least one of the insertion instrument and the adjustment instrument are manufactured and sterile packed for single use.
14 . The kit of claim 12 , wherein the expandable disc replacement body includes a first bone-screw receiving section at a proximal end of the first wall, and a second bone-screw receiving section at the proximal end of the second wall.
15 . The kit of claim 14 , wherein the anterior plate includes at least one hole for receiving a bone screw.
16 . The kit of claim 14 , wherein the angle adjustment instrument includes pins dimensioned to engage pin holes in the expandable disc replacement body, the pins allowing the angle adjustment instrument to apply torque to the expandable disc replacement body to open the expandable disc replacement body to the angle.