DUAL-AXIS ADJUSTABLE SPINAL SYSTEMS AND INTERBODY FUSION DEVICES WITH FIXATION
An apparatus or a system employs a fixation assembly to stabilize and prevent migration of an interbody fusion device placed between adjacent vertebral bodies, and/or provide supplemental fixation of adjacent vertebral bodies. The fixation assembly may include modular fixation plates insertable and attachable to the interbody fusion device in situ. In certain embodiments, the fixation assembly may include a single fixation plate insertable and/or attachable to the interbody fusion device in situ. In certain embodiments, fixation plates are integrally formed with the interbody fusion device.
1 - 78 . (canceled)
79 . An apparatus comprising an interbody fusion device and a fixation assembly, wherein
the interbody fusion device comprising a housing, a first wedge member, a second wedge member, a first drive shaft, and a second drive shaft, wherein
the housing comprises a first shell member and a second shell member, the first and second shell members engaging the first wedge member along a first lateral area of the housing, and engaging the second wedge member along a second lateral area of the housing,
the first wedge member is provided with a through-opening configured to allow the first drive shaft to pass, the second wedge member is provided with a through-opening configured to allow the second drive shaft to pass, and
the first drive shaft is operable to drive the first wedge member along the first lateral area of the housing, the second drive shaft is operable to drive second wedge member along the second lateral area of the housing, causing the first and second shell members to move relative to each other providing an expanded configuration of the interbody fusion device; and
the fixation assembly comprising a first fixation plate configured to be attachable to the interbody fusion device, thereby allowing the first fixation plate to be attached to the interbody fusion device in the expanded configuration and secured to a first vertebral body to stabilize and/or prevent migration of the interbody fusion device.
80 . The apparatus of claim 79 , wherein the first fixation plate is modular and configured to be attached to the interbody fusion device in the expanded configuration in situ.
81 . The apparatus of claim 80 wherein the fixation assembly further comprises a second fixation plate, the second fixation plate being modular and configured to be attached to the interbody fusion device in the expanded configuration in situ and secured to a second vertebral body to stabilize and/or prevent migration of the interbody fusion device.
82 . The apparatus of claim 79 , wherein the first fixation plate is a single fixation plate, the single fixation plate being configured to be attached to the interbody fusion device in the expanded configuration and secured to the first vertebral body and a second vertebral body adjacent to the first vertebral body.
83 . The apparatus of claim 82 , wherein the single fixation plate is modular and configured to be attached to the interbody fusion device in situ.
84 . The apparatus of claim 82 , wherein the single fixation plate is constructed from a material having strength capable of providing supplemental fixation of the first and the second vertebral bodies.
85 . The apparatus of claim 82 , wherein the single fixation plate is rotatable relative to the interbody fusion device, thereby allowing positioning of the of the single fixation plate to be adjusted in situ, and wherein the single fixation plate is constructed to be capable of providing supplemental fixation of the first and second vertebral bodies.
86 . The apparatus of claim 85 , wherein the single fixation plate is rotatable relative to an imaginary plane containing the first and the second drive shafts of the interbody fusion device at an angle from 0 to 11 degrees clockwise and/or counterclockwise, thereby allowing the positioning of the single fixation plate to be adjusted in situ at an angle from 0 to 11 degrees clockwise and/or counterclockwise.
87 . The apparatus of claim 79 , wherein the fixation assembly further comprises a second fixation plate, wherein the first fixation plate is coupled to the first shell member and the second fixation plate is coupled to the second shell member, thereby allowing the first and the second fixation plates to be implanted with the interbody fusion device, angle-adjusted in situ with movement of the first shell member and/or second shell member, and secured to adjacent vertebral bodies to stabilize and/or prevent migration of the interbody fusion device.
88 . The apparatus of claim 87 , wherein the first fixation plate is integrally formed with the first shell member, and/or, the second fixation plate is integrally formed with the second shell member.
89 . The apparatus of claim 87 , wherein the first fixation plate is a separate piece and coupled to the first shell member by interference fit or screw coupling, and/or, the second fixation plate is a separate piece and coupled to the second shell member by interference fit or screw coupling.
90 . An apparatus comprising an interbody fusion device and a fixation assembly, wherein
the interbody fusion device comprising an expandable housing, a first driving mechanism operable to expand and/or contract the housing along a first lateral side of the housing, and a second driving mechanism operable to expand and/or contract the housing along a second lateral side of the housing, and
the fixation assembly comprising a first fixation plate having a first aperture for insertion of a first fastener, wherein the first fixation plate is modular and configured to be attachable to the interbody fusion device, thereby allowing the first fixation plate to be attached to the interbody fusion device in the expanded configuration in situ and fastened to a first vertebral body to stabilize and/or prevent migration of the interbody fusion device.
91 . The apparatus of claim 90 , wherein the fixation assembly further comprises a second fixation plate having a second aperture for insertion of a second fastener, the second fixation plate being modular and configured to be attachable to the interbody fusion device, thereby allowing the second fixation plate to be attached to the interbody fusion device in the expanded configuration in situ and fastened to a second vertebral body to stabilize and/or prevent migration of the interbody fusion device.
92 . The apparatus of claim 90 , wherein
the first fixation plate is a single fixation plate;
the fixation assembly comprises the first fastener and further a second fastener,
the single fixation plate is provided with the first aperture for insertion of the first fastener therethrough to the first vertebral body and further a second aperture for insertion of the second fastener therethrough to a second vertebral body, thereby allowing the single fixation plate to be attached to the interbody fusion device in situ and secured to the first and the second vertebral bodies to stabilize and/or prevent migration of the interbody fusion device.
93 . The apparatus of claim 92 , wherein the single fixation plate is constructed from a material having strength capable of providing supplemental fixation of the first and second vertebral bodies.
94 . The apparatus of claim 92 ,
wherein the single fixation plate is insertable into the interbody fusion device in situ and rotatable relative to the interbody fusion device, thereby allowing positioning of the first aperture and the second aperture in the single fixation plate to be adjusted in situ, the single fixation plate being constructed to be capable of providing supplemental fixation of the first and second vertebral bodies.
95 . The apparatus of claim 94 , wherein the single fixation plate is rotatable relative to an imaginary plane at an angle from 0 to 11 degrees clockwise and/or counterclockwise, thereby allowing the positioning of the single fixation plate to be adjusted in situ at an angle from 0 to 11 degrees clockwise and/or counterclockwise.
96 . An apparatus comprising an interbody fusion device and a fixation assembly, wherein
the interbody fusion device comprising an expandable housing including a first shell member and a second shell member, a first driving mechanism operable to expand and/or contract the housing along a first lateral side of the housing, and a second driving mechanism operable to expand and/or contract the housing along a second lateral side of the housing, and
the fixation assembly comprising a first fixation plate having a first aperture for insertion of a first fastener and a second fixation plate having a second aperture for insertion of a second fastener, wherein
the first fixation plate is coupled to the first shell member and the second fixation plate is coupled to the second shell member, thereby allowing the first and second fixation plates to be implanted with the interbody fusion device, angle-adjusted in situ with movement of the first shell member and/or second shell member, and fastened to adjacent vertebral bodies to stabilize and/or prevent migration of the interbody fusion device.
97 . The apparatus of claim 96 , wherein the first fixation plate is integrally formed with the first shell member, and/or, the second fixation plate is integrally formed with the second shell member.
98 . The apparatus of claim 96 , wherein the first fixation plate is a separate piece and coupled to the first shell member by interference fit or screw coupling, and/or, the second fixation plate is a separate piece and coupled to the second shell member by interference fit or screw coupling.