Biaxial adjustable spinal system and interbody fusion device using a fusion apparatus - Patents.com

Abstract

The device or system employs a fixation assembly to stabilize an interbody fusion device placed between adjacent vertebral bodies to prevent migration thereof and / or to provide a complementary fixation device for the adjacent vertebral bodies. The fixation assembly can have a modular fixation plate that is insertable and attachable in situ to the interbody fusion device. In certain embodiments, the fixation assembly can have a single fixation plate that is insertable and / or attachable in situ to the interbody fusion device. In certain embodiments, the fixation plate is integrally formed with the interbody fusion device.

Description

[Technical field]

[0001]

[0001] The present disclosure relates generally to apparatus, systems and methods for treating spinal disorders. In particular, various embodiments of a biaxial adjustable spinal system and a biaxial interbody fusion device using a modular integrated fusion apparatus are described. [Background technology]

[0002]

[0002] Spinal fusion is a surgical procedure to correct problems associated with the human spine, such as degenerative disc disease (DDD), spondylolisthesis, and recurrent disc herniation. Spinal fusion generally involves removing damaged discs and bone between adjacent vertebrae and inserting bone graft material that promotes bone growth. As the bone grows, the adjacent vertebrae join or fuse together. Fusing the bones together can help make certain areas of the spine more stable and can help reduce problems associated with nerve irritation at the fusion site. Fusion can be performed on one or more segments of the spine.

[0003] In an interbody fusion procedure, the nucleus pulposus and / or annulus fibrosus that make up the intervertebral disc at the point of injury are removed, and an implant of appropriate shape and size is placed in the intervertebral space to restore the proper distance between adjacent vertebrae. The surgical approaches to perform interbody fusion are varied, and access to the patient's spine may be through the abdomen or back. One surgical method to achieve minimally invasive lumbar spinal fusion involves accessing the spine through a small incision on the posterior side, where the surgeon removes portions of the bone and joints on the back and sides of the vertebrae. These sections of bone and joints are called the lamina and facet joints, respectively. This procedure is known as transforaminal lumbar interbody fusion or lateral lumbar interbody fusion. This technique allows the surgeon to insert bone grafts and spacers into the disc space laterally through a unilateral approach without the need for forced retraction of the nerve root, thereby reducing trauma and scarring around the nerve root compared to more traditional posterior procedures.

[0004]

[0004] Conventionally, when an intervertebral disc is removed from the body, a surgeon will usually push various trial implants between the vertebral bodies in a particular area to determine the size of the implant to maintain the appropriate distance between the adjacent vertebrae. Furthermore, the appropriate angle between the vertebral bodies must be maintained to accommodate the natural curvature of the spine, such as lordosis. Therefore, both the height of the intervertebral disc and the lordosis must be considered during the selection of a fusion device for implantation. Conventional implant devices are often pre-configured to have top and bottom angles to accommodate the natural curvature of the spine. It is unlikely or difficult to be able to accurately determine these values ​​before the operation. Furthermore, the patient is subjected to significant invasive procedures when performing a trial and error approach to size and fit the interbody fusion device into the target area for geometric configuration. If a hyperlordotic sagittal profile configuration (≥20°) is established or a complementary fusion device for the lumbosacral level is desired, the surgeon may place a spinal construct such as an additional plate-screw assembly in the form of an anterior spinal fusion device to prevent possible migration of the fusion device within the disc space and / or to provide temporary anterior spinal stabilization during the spinal fusion process until arthrodesis can be performed. This may require the surgeon to perform a secondary surgery after placing the fusion device, thereby extending the overall operative time and causing more potential blood loss and anesthesia-related complications for the patient. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent No. 9,889,019 [Patent Document 2] U.S. Patent No. 10,188,527 [Patent Document 3] U.S. Patent Application Serial No. 16 / 569,621 [Patent Document 4] U.S. Patent Application Serial No. 15 / 661,435 [Patent Document 5] U.S. Patent Application Serial No. 16 / 035,637 Summary of the Invention [Means for solving the problem]

[0006]

[0005] An embodiment of the apparatus includes an interbody fusion device and a fixation assembly that can have one or more modular fixation plates insertable and attachable in situ to the interbody fusion device and one or more fasteners for stabilizing the interbody fusion device between adjacent vertebral bodies to prevent movement thereof.

[0007]

[0006] An embodiment of the system includes an interbody fusion device and a fixation assembly. The fixation assembly can have a single fixation plate insertable and attachable in situ to the interbody fusion device and two or more fasteners for stabilizing the interbody fusion device between adjacent vertebral bodies to prevent its movement. Optionally, the single fixation plate provides a complementary fixation device for adjacent vertebrae.

[0008]

[0007] An embodiment of the system includes an interbody fusion device and a fixation assembly. The fixation assembly can have a single fixation plate that is insertable and attachable in situ to the interbody fusion device, and two or more fasteners for stabilizing the interbody fusion device between adjacent vertebral bodies to prevent its movement. The single fixation plate can be rotated or angled relative to the interbody fusion device in situ to provide a complementary fixation of the adjacent vertebrae.

[0009]

[0008] An embodiment of an apparatus includes an interbody fusion device and a fixation assembly for stabilizing the interbody fusion device between adjacent vertebral bodies to prevent movement thereof. The fixation assembly can include one or more fixation plates and one or more fasteners formed integrally with the interbody fusion device.

[0010]

[0009] This Summary is provided to introduce selected embodiments in a simplified form, is not intended to identify key features or essential characteristics of the claimed subject matter, and is not intended to be used as an aid in determining the scope of the claimed subject matter. The selected embodiments are presented merely to provide the reader with a general overview of certain forms the invention may take, and are not intended to limit the scope of the invention. Other aspects and embodiments of the disclosure are described in the Detailed Description.

[0011]

[0010] These and various other features and advantages of the present disclosure may be better understood from the following detailed description and the appended claims, taken in conjunction with the accompanying drawings. [Brief description of the drawings]

[0012] [Figure 1A]

[0011] FIG. 1 is an isometric view of an exemplary biaxial adjustable interbody fusion device according to an embodiment of the present disclosure. [Figure 1B] 1 is a side view of an exemplary biaxial adjustable interbody fusion device according to an embodiment of the present disclosure. [Figure 1C] 1 is a cross-sectional view illustrating an exemplary bi-axial adjustable interbody fusion device according to an embodiment of the present disclosure. [Diagram 2]

[0012] Figures 2A and 2B are partial exploded and assembled views of an exemplary biaxial adjustable interbody fusion device using a modular fusion apparatus according to an embodiment of the present disclosure. [Diagram 3]

[0013] 3A, 3B, 3C, 3D are isometric front and exploded views, respectively, of an exemplary modular lower fixation plate according to an embodiment of the present disclosure, and are side and front views, respectively, of an exemplary modular lower fixation plate according to an embodiment of the present disclosure. [Figure 4]

[0014] Figures 4A, 4B, 4C, 4D are isometric front, exploded, and side views of an exemplary modular upper fixation plate according to an embodiment of the present disclosure. [Figure 5A]

[0015] FIG. 13 is an isometric view showing attachment of a modular inferior fixation plate to a biaxial adjustable interbody fusion device. [Figure 5B] FIG. 13 is a partial enlarged view showing attachment of a modular lower fixation plate to a biaxial adjustable interbody fusion device, showing the unlocked attachment. [Figure 5C] 13A-13C are cross-sectional views illustrating attachment of a modular inferior fixation plate to a biaxial adjustable interbody fusion device. [Figure 5D] FIG. 13 is a partial enlarged cross-sectional view showing attachment of a modular inferior fixation plate to a biaxial adjustable interbody fusion device, showing the unlocked attachment. [Figure 6A]

[0016] FIG. 13 is an isometric view showing attachment of a modular inferior fixation plate to a biaxial adjustable interbody fusion device in a locked state. [Figure 6B] FIG. 13 is a partial enlarged view showing attachment of a modular lower fixation plate to a biaxial adjustable interbody fusion device in a locked state, showing the attachment in a locked state. [Figure 6C] FIG. 13 is a cross-sectional view showing attachment of a modular inferior fixation plate to a biaxial adjustable interbody fusion device in a locked state. [Figure 6D] FIG. 13 is a partial enlarged cross-sectional view showing attachment of a modular inferior fixation plate to a bi-axis adjustable interbody fusion device in a locked state, showing attachment in a locked state. [Figure 7A]

[0017] FIG. 13 is an isometric view illustrating channel geometry in a modular lower fixture plate according to an embodiment of the present disclosure. [Figure 7B] 13A is a cross-sectional view of a channel geometry in a modular inferior fixation plate according to an embodiment of the present disclosure showing reception of a drive shaft of a bi-axis adjustable interbody fusion device at the lower end of the channel geometry. [Figure 7C] FIG. 13 is an isometric view illustrating channel geometry in a modular lower fixture plate according to an embodiment of the present disclosure. [Figure 7D] 13A is a cross-sectional view of a channel geometry in a modular lower fixation plate according to an embodiment of the present disclosure showing reception of a drive shaft at an upper end of the channel geometry. FIG. [Figure 8]

[0018] 8A and 8B illustrate the attachment of a modular upper fixation plate to a biaxial adjustable interbody fusion device, showing the attachment in an unlocked state and a locked state, respectively. [Figure 9A]

[0019] 13A-13D illustrate attachment of a modular lower fixation plate and a modular upper fixation plate to a biaxial adjustable interbody fusion device in a collapsed configuration. [Figure 9B] 13A-13D illustrate attachment of a modular lower fixation plate and a modular upper fixation plate to a biaxial adjustable interbody fusion device in an expanded configuration. [Figure 9C] 13A-13D illustrate attachment of a modular lower fixation plate and a modular upper fixation plate to a biaxial adjustable interbody fusion device in a lordosis adjustment configuration. [Figure 10]

[0020] 10A and 10B illustrate the attachment of a modular upper and lower fixation plate to a biaxial adjustable interbody fusion device placed between adjacent vertebrae using surgical instruments. [Figure 11]

[0021] 11A and 11B are anterolateral and front perspective views of a biaxial adjustable interbody fusion device secured to adjacent vertebral bodies by lower and upper fixation plates. [Figure 12A]

[0022] FIG. 1 illustrates an exploded view of an exemplary biaxial adjustable articulating spinal system according to an embodiment of the present disclosure. [Figure 12B] FIG. 1 illustrates an exploded view of an exemplary biaxial adjustable articulating spinal system according to an embodiment of the present disclosure. [Figure 12C] 1 is an assembled view of an exemplary biaxial adjustable articulating spinal system according to an embodiment of the present disclosure; FIG. [Figure 12D] 1 is an assembled view of an exemplary biaxial adjustable articulating spinal system according to an embodiment of the present disclosure; FIG. [Figure 12E] 1 is a cross-sectional view illustrating an exemplary bi-axis adjustable articulating spinal system according to an embodiment of the present disclosure. [Figure 13A]

[0023] FIG. 13 is a front view of an exemplary single fixation plate according to an embodiment of the present disclosure. [Figure 13B] FIG. 13 illustrates an exploded view of an exemplary single fixation plate according to an embodiment of the present disclosure. [Figure 13C]FIG. 13 is a rear view of an exemplary single fixation plate according to an embodiment of the present disclosure. [Figure 13D] FIG. 13 is a side cross-sectional view of an exemplary single fixation plate according to an embodiment of the present disclosure. [Figure 13E] FIG. 13 is a side view of an exemplary single fixation plate according to an embodiment of the present disclosure. [Figure 13F] FIG. 13 is a rear view of an exemplary single fixation plate according to an embodiment of the present disclosure. [Figure 14]

[0024] 14A and 14B illustrate the installation of a single fixation plate and screw assembly to a biaxial adjustable interbody fusion device, showing an unlocked installation and a locked installation, respectively. [Figure 15]

[0025] 15A and 15B are perspective views of a fastener locking mechanism as part of a fixation plate according to an embodiment of the present disclosure showing the locking mechanism in an open state and a locked state, respectively. [Figure 16]

[0026] 16A and 16B are front and side cross-sectional views showing the angled structure of apertures in a single fixation plate. [Figure 17A]

[0027] 13A-13C illustrate attachment of a single fixation plate to a biaxial adjustable interbody fusion device in a collapsed configuration. [Figure 17B] 13A-13D illustrate attachment of a single fixation plate to a biaxial adjustable interbody fusion device in an expanded configuration. [Figure 17C] 13A-13C illustrate the attachment of a single fixation plate to a biaxial adjustable interbody fusion device in a lordosis adjustment configuration. [Figure 18]

[0028] 13A-13D illustrate attachment of a single fixation plate to a biaxial adjustable interbody fusion device that is placed between adjacent vertebrae using surgical instruments. [Figure 19]

[0029] 19A and 19B are side and front perspective views of a biaxial adjustable interbody fusion device secured to adjacent vertebral bodies by a single fixation plate. [Figure 20A]

[0030] FIG. 1 is a partially exploded view illustrating an exemplary bi-axis adjustable variable spine system according to an embodiment of the present disclosure. [Figure 20B] FIG. 1 is a partially exploded view illustrating an exemplary bi-axis adjustable variable spine system according to an embodiment of the present disclosure. [Figure 20C] 1 is an assembled view illustrating an exemplary bi-axis adjustable variable spine system according to an embodiment of the present disclosure. [Figure 20D] 1 is an assembled view illustrating an exemplary bi-axis adjustable variable spine system according to an embodiment of the present disclosure. [Figure 21A]

[0031] FIG. 13 is a front view of an exemplary single fixation plate according to an embodiment of the present disclosure. [Figure 21B] FIG. 13 illustrates an exploded view of an exemplary single fixation plate according to an embodiment of the present disclosure. [Figure 21C] FIG. 13 is a rear view of an exemplary single fixation plate according to an embodiment of the present disclosure. [Figure 21D] FIG. 13 is a side cross-sectional view of an exemplary single fixation plate according to an embodiment of the present disclosure. [Figure 21E] FIG. 13 is a side view of an exemplary single fixation plate according to an embodiment of the present disclosure. [Figure 21F] FIG. 13 is a rear view of an exemplary single fixation plate according to an embodiment of the present disclosure. [Figure 22]

[0032] 22A and 22B illustrate the attachment of a single fixation plate to a biaxial adjustable interbody fusion device, showing the attachment in an unlocked state and a locked state, respectively. [Figure 23A]

[0033] 21A-21F are isometric end views showing the ability to angle the single fixation plate depicted in FIGS. 21A-21F relative to a dual-axis adjustable interbody fusion device in accordance with an embodiment of the present disclosure. [Figure 23B] 21A-21F are cross-sectional end views illustrating the ability to angle the single fixation plate depicted in FIGS. 21A-21F relative to a dual-axis adjustable interbody fusion device in accordance with an embodiment of the present disclosure. [Figure 23C] 21A-21F are isometric side views illustrating the ability to angle the single fixation plate depicted in FIGS. 21A-21F relative to a dual-axis adjustable interbody fusion device in accordance with an embodiment of the present disclosure. [Figure 23D] 21A-21F are another isometric side views illustrating the ability to angle the single fixation plate depicted in FIGS. 21A-21F relative to a dual-axis adjustable interbody fusion device in accordance with an embodiment of the present disclosure. [Figure 24A]

[0034] 13A-13D illustrate attachment of a single fixation plate to a biaxial adjustable interbody fusion device in a collapsed configuration. [Figure 24B] 13A-13D illustrate attachment of a single fixation plate to a biaxial adjustable interbody fusion device in an expanded configuration. [Figure 24C] 13A-13C illustrate attachment of a single fixation plate to a biaxial adjustable interbody fusion device in a lordosis adjustment configuration. [Figure 24D] 13A-13C illustrate attachment of a single fixation plate to a biaxial adjustable interbody fusion device in a lordosis adjustment configuration. [Diagram 25]

[0035] 25A and 25B are side and front perspective views of an exemplary biaxial adjustable interbody fusion device secured to adjacent vertebral bodies by a single fixation plate. [Figure 26A]

[0036] 1 is a partially exploded view illustrating an exemplary biaxial adjustable interbody fusion device with an integrated fusion apparatus according to an embodiment of the present disclosure. [Figure 26B] 1 is an isometric assembly view illustrating an exemplary biaxial adjustable interbody fusion device with an integrated fusion apparatus according to an embodiment of the present disclosure. FIG. [Figure 26C] 1 is a front assembly view illustrating an exemplary biaxial adjustable interbody fusion device with an integrated fusion apparatus according to an embodiment of the present disclosure. FIG. [Figure 26D] 1A-1C are end assembled views illustrating an exemplary biaxial adjustable interbody fusion device with an integrated fusion apparatus, according to an embodiment of the present disclosure. [Figure 27]

[0037] 27A and 27B are diagrams illustrating an example fastener locking mechanism according to an embodiment of the present disclosure, showing the fastener locking mechanism in an unlocked state and a locked state, respectively. [Figure 28]

[0038] 1A-1C are cross-sectional views of an exemplary biaxial adjustable interbody fusion device using integrated fusion apparatus, highlighting fastener heads received in countersinks of apertures in the integrated fixation plate. [Figure 29]

[0039] 29A and 29B illustrate the angulation of an integrated fixation plate in an exemplary bi-axis adjustable interbody fusion device in an expanded configuration and a lordosis adjustment configuration, respectively. [Diagram 30]

[0040] 13A-13D illustrate the fixation of an exemplary biaxial adjustable interbody fusion device with an integrated fusion apparatus to adjacent vertebral bodies using surgical instruments. [Diagram 31]

[0041] 31A and 31B are anterior lateral and front perspective views of an exemplary biaxial adjustable interbody fusion device with integrated fixation plates secured to adjacent vertebral bodies. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013]

[0042] Various embodiments of spinal systems and interbody fusion devices using fusion apparatuses will now be described with reference to Figures 1A-31B, in which like reference numerals denote like parts. It should be noted that these figures are merely intended to facilitate the description of the embodiments, and are not intended to be comprehensive or to limit the scope of the present disclosure. Furthermore, certain specific details are shown in the figures to enable a thorough understanding of various embodiments of the present disclosure. Those skilled in the art will understand that the claimed invention may be practiced without these details. Also, well-known components, structures, or steps associated with the apparatus, system, and method of the present disclosure may not be shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present disclosure. Furthermore, it should be noted that a particular aspect or feature described in conjunction with a specific embodiment is not necessarily limited to this embodiment only, but may also be practiced in any other embodiment.

[0014]

[0043] In general, various embodiments of an apparatus or system for treating spinal disorders include an interbody fusion device and a fixation assembly. The interbody fusion device can be placed between adjacent vertebrae in a region of the patient's spine. The configuration of the interbody fusion device can be adjusted to achieve, for example, an expansion configuration, a lordotic configuration, a kyphotic configuration, a large lordotic configuration, or a large kyphotic configuration appropriate for treating the patient. The fixation assembly provides stabilization and prevents movement of the interbody fusion device in the expansion configuration and / or lordotic adjustment configuration to facilitate safe body fusion. Alternatively or additionally, the fixation assembly provides a corrective support or a complementary fixation device to hold adjacent vertebrae in position as may be required to treat a particular spinal disorder. To facilitate the description of the present disclosure, the phrase "interbody fusion device using a fusion device" may be used to indicate an apparatus having an interbody fusion device and a fixation assembly for stabilizing the interbody fusion device and preventing its movement; and the phrase "spinal system" may be used to indicate a system having an interbody fusion device and a fixation assembly for stabilizing the interbody fusion device and preventing its movement and / or for providing a complementary fusion device intended to hold adjacent vertebrae in place.

[0015]

[0044] Biaxial Adjustable Interbody Fusion Device

[0045] The interbody fusion device included in the spinal system and apparatus of the present disclosure may be any suitable fusion device. According to certain embodiments of the present disclosure, the interbody fusion device may be a biaxial adjustable fusion device. The biaxial adjustable interbody fusion device has two drive mechanisms that can be operated separately, independently, or simultaneously in situ to adjust the configuration of the interbody fusion device having a height and / or shape suitable for treating a patient. For example, the configuration of the biaxial interbody fusion device disposed between adjacent vertebrae may be adjusted by operating the two drive mechanisms along the anterior and / or posterior sides of the patient, respectively, to achieve the patient's desired sagittal balance or to correct the patient's sagittal imbalance. The configuration of the biaxial adjustable interbody fusion device disposed between adjacent vertebrae may be adjusted by operating the drive mechanisms along the lateral and / or contralateral sides of the patient to achieve the patient's desired coronal balance or to correct the patient's coronal imbalance.

[0016]

[0046] An exemplary biaxial adjustable interbody fusion device can have a housing, a first wedge member, a second wedge member, a first drive shaft, and a second drive shaft. The housing can have a first shell member and a second shell member. The first and second shell members can be engaged to the first wedge member along a first lateral area of ​​the housing and engaged to the second wedge member along a second lateral area of ​​the housing. The first wedge member can be equipped with a through opening configured to allow the first drive shaft to pass therethrough. The second wedge member can be equipped with a through opening configured to allow the second drive shaft to pass therethrough. The first and second wedge members can be tapered members. Exemplary tapered members include, but are not limited to, a rotatable tapered screw and a slidable tapered plate.

[0017]

[0047] The first drive shaft can be operable to drive the first wedge member along the first lateral area of ​​the housing and the second drive shaft can be operable to drive the second wedge member along the second lateral area of ​​the housing, causing the first and second shell members to move relative to one another, thereby expanding the interbody fusion device. The first and second drive shafts can be independently operated to drive the first and second wedge members to different positions, thereby causing expansion of the interbody fusion device along the first lateral area of ​​the housing to a different extent than the extent of expansion of the interbody fusion device along the second lateral area of ​​the housing.

[0018]

[0048] The first and second wedge members may be tapered members configured to slide along the first and second lateral sides of the housing to expand or contract the interbody fusion device. Alternatively, the first and second wedge members may be threaded screw members configured to rotate and move along the first and second lateral sides of the housing to expand or contract the interbody fusion device. For example, the interbody fusion device may include a first pair of screw members and a second pair of screw members. The first shell member may include a plurality of individual riser members and the second shell member may include a plurality of individual riser members. The plurality of individual riser members of the first shell member and the plurality of individual riser members of the second shell member may define a first tracking run along the first lateral area of ​​the housing and a second tracking run along the second lateral area of ​​the housing. The first drive shaft may be operable to rotate the first pair of threaded members, thereby enabling the first pair of threaded members to advance along the first drive shaft and move on a first tracking run, and the second drive shaft may be operable to rotate the second pair of threaded members, thereby enabling the second pair of threaded members to advance along the second drive shaft and move on a second tracking run.

[0019]

[0049] Various embodiments of interbody fusion devices are described in U.S. Patent No. 9,889,019, U.S. Patent No. 10,188,527, and U.S. patent application Ser. No. 16 / 569,621, entitled "Expandable and Adjustable Lordosis Interbody Fusion System," filed Sep. 12, 2019. The disclosures of U.S. Patent No. 9,889,019, U.S. Patent No. 10,188,527, and U.S. patent application Ser. No. 16 / 569,621 are incorporated herein by reference in their entireties.

[0020]

[0050] 1A-1C illustrate an exemplary biaxial adjustable interbody fusion device 10 that may be used in a spinal system or apparatus according to an embodiment of the present disclosure. As shown, the biaxial adjustable interbody fusion device 10 has an expandable housing 12, a first pair of screw members 14a, 14b, a second pair of screw members 16a, 16b, a first drive shaft 24, and a second drive shaft 26. The first pair of screw members 14a, 14b may each be provided with a through opening configured to allow the first drive shaft 24 to pass through and engage the first pair of screw members 14a, 14b. The second pair of screw members 16a, 16b may each be provided with a through opening configured to allow the second drive shaft 26 to pass through and engage the second pair of screw members 16a, 16b.

[0021]

[0051] The housing 12 can have a first or lower shell member 32 and a second or upper shell member 34. The lower shell member 32 can have a plurality of individual riser members 42 (FIG. 1B). The upper shell member 34 can have a plurality of individual riser members 44 (FIG. 1B). The plurality of individual riser members 42, 44 of the lower shell member 32 and the upper shell member 34 can define a first step tracking run 46 along the first lateral area 13 of the housing 12 and a second step tracking run 48 along the second lateral area 15 of the housing 12 (FIG. 1C). The heights of the plurality of individual riser members 42, 44 can vary along the first step tracking run 46 and the second step tracking run 48. For example, the height of the plurality of individual riser members 42, 44 of each of the first step tracking run 46 and the second step tracking run 48 can increase from a step tracking central portion extending distally from the central portion 50. The first and second pairs of threaded members 14a-14b and 16a-16b can each include a helical thread having a thickness configured to fit within a gap between adjacent individual riser members.

[0022]

[0052] The first drive shaft 24 is operable to rotate the first pair of threaded members 14a, 14b, which causes the first pair of threaded members 14a, 14b to move on the respective riser members 42, 44 along a first step tracking run 46. The second drive shaft 26 is operable to rotate the second pair of threaded members 16a, 16b, which causes the second pair of threaded members 16a, 16b to move on the respective riser members 42, 44 along a second step tracking line 48. In response to the rotation of the first pair of threaded members 14a-14b and the second pair of threaded members 16a-16b, the upper shell member 32 and the lower shell member 34 may move relative to one another, thereby achieving an expansion of the housing 12 or, by reversing the rotation of the first and / or second pairs of threaded members, contracting the housing 12 from an expanded state. The first and second drive shafts 24, 26 may be operable independently of one another such that when the first set of threaded members 14a-14b and the second set of threaded members 16a-16b are independently rotated to different positions on the first and second step tracking runs 46, 48, the degree of expansion or contraction of the first lateral area 13 of the housing 12 is independently adjustable relative to the degree of expansion or contraction of the second lateral area 15 of the housing 12.

[0023]

[0053] The positions of the multiple individual riser members 42 on the lower shell member 32 can be configured to be offset from the positions of the multiple individual riser members 44 on the upper shell member 34 such that when the housing 12 is in a contracted configuration, the multiple individual riser members 42 of the lower shell member 32 can interlock with the multiple individual riser members 44 of the upper shell member 34.

[0024]

[0054] The first pair of threaded members 14a-14b and the second pair of threaded members 16a-16b may each have a tapered configuration and may include helical threads. The first pair of threaded members 14a-14b may be configured or arranged such that the directional orientation of the helical threads of the first threaded member 14a of the first pair is opposite to the directional orientation of the helical threads of the second threaded member 14b of the first pair, such that the first and second threaded members 14a-14b of the first pair move in opposite directions relative to each other within the first step tracking run 46 upon rotation of the first drive shaft 24. Similarly, the second pair of threaded members 16a-16b may be configured or arranged such that the direction of the helical threads of the first threaded member 16a of the second pair is opposite to the direction of the helical threads of the second threaded member 16b of the first pair, such that upon rotation of the second drive shaft 26, the first and second threaded members 16a-16b of the second pair move in opposite directions relative to each other in the second step tracking run 48.

[0025]

[0055] For example, the first pair of screw members 14a-14b and the second pair of screw members 16a-16b can be configured such that when the first drive shaft 24 is rotated in a first direction, e.g., a clockwise direction, the first pair of screw members 14a-14b are each moved distally from the central portion 50 along the first step tracking run 46, and when the second drive shaft 26 is rotated in a second direction opposite the first direction, e.g., a counterclockwise direction, the second pair of screw members 16a-16b are each moved distally from the central portion 50 along the second step tracking run 48. The first pair of screw members 14a-14b and the second pair of screw members 16a-16b can be configured such that when the first drive shaft 414 is rotated in a first direction, the first pair of screw members 14a, 14b are each moved distally from the central portion 50 along the first step tracking run 46, and when the second drive shaft 26 is rotated in a second direction that is the same as the first direction, the second pair of screw members 16a-16b are each moved distally from the central portion 50 along the second step tracking run 48.

[0026]

[0056] The first drive shaft 24 and the second drive shaft 26 can each have structure at their end portions for connection to a surgical instrument and for receiving and engaging a driver in a surgical instrument. For example, the end portions of each of the first drive shaft 24 and the second drive shaft 26 can be equipped with male threads 25 for connection to a surgical instrument and female threads 27 for receiving and engaging a driver in a surgical instrument (FIG. 1A).

[0027]

[0057] The biaxial adjustable interbody fusion device 10 may have one or more tension springs 52, 54 connecting the lower shell member 32 and the upper shell member 34. The tension springs 52, 54 may ensure that the entire device remains together. The patient may have extreme coronal or sagittal imbalance, which may result in a non-uniform force distribution applied to the interbody fusion device when implanted in the patient. Non-uniform force distribution on the internal mechanisms may cause the fusion device to separate. Additionally, the tension springs 52, 54 may function to maintain opposing forces on the fusion apparatus. When pressure is applied to the upper and lower shell members of the device, the internal mechanisms of the fusion device may undergo expansion and / or lordotic adjustment. An equal and opposing force may be required to move the mechanisms efficiently and accurately. Tension springs 52, 54 can generate an initial tension on the mechanism, allowing the mechanism to expand when, for example, the patient's vertebral bodies are not in contact with the device, and / or allowing lordosis to be adjusted when, for example, the patient's vertebral bodies are not in contact with the device.

[0028]

[0058] The interbody fusion device 10 can have one or more thrust bearings 60 configured to limit undesired axial and / or lateral movement of the drive shafts 24, 26 while allowing rotation of the drive shafts 24, 26 about their longitudinal axes. The thrust bearings 60 can be designed with an angled geometry 62 (FIG. 1A) that allows for guiding an instrument carrying bone graft material into the device housing 12. Additionally, the angled geometry can allow for a fixation plate to be inserted into the interbody fusion device to stabilize and prevent movement of the interbody fusion device placed in adjacent vertebrae as described in more detail below.

[0029]

[0059] The lower and upper shell members 32, 34 of the housing 12 may have one or more openings or windows for receiving bone graft material or for allowing bone to pass when performing the fusion procedure. Suitable bone graft materials include, but are not limited to, autologous and / or allogeneic bone graft materials, including, for example, cancellous bone grafts and / or corticocancellous bone grafts. The bone graft material may be packed into the interbody fusion device 10 before it is placed between the vertebral bodies and / or may be added after expansion and / or lordotic adjustment to properly configure the interbody fusion device 10 between the vertebral bodies. The sides or edges of the lower and upper shell members 32, 34 may have chamfers or rounded portions to facilitate insertion of the interbody fusion device into the patient's anatomy. The surfaces of the lower and upper shell members 32, 34 can have various features such as sawtooth, teeth, recesses, indentations, etc. to help prevent device movement and provide better retention.

[0030]

[0060] Interbody fusion device 10 or portions of interbody fusion device 10 may be constructed from materials including metals, such as titanium, tantalum, stainless steel, any other biocompatible metal or alloy, etc. Interbody fusion device 10 or portions of interbody fusion device 10 may also be constructed from polymeric materials, such as polyetheretherketone (PEEK), polyetherketoneketone (PEKK), and polyetherketone (PEK).

[0031]

[0061] The interbody fusion device 10 can have any size suitable for a spinal fusion procedure. For example, the distance from the proximal end to the distal end of the device along the direction of the drive shafts 24, 26 ("length") can range from 30 millimeters (mm) to 60 mm. The distance from one lateral side of the device to the opposite lateral side ("width") can range from 10 mm to 30 mm. The device can be manufactured in multiple offerings having various lengths and widths in various increments, such as 2 mm increments in width and 5 mm increments in length. The distance from the surface of the lower shell member to the surface of the upper shell member of the interbody fusion device in a fully collapsed configuration ("base height") can range from 5 mm to 10 mm. Dual-axis drive mechanisms according to embodiments of the present disclosure can provide continuous expansion in height adjustment ranging from, for example, 0 mm to 8 mm when operated together simultaneously or ranging from, for example, 0 to 9 mm when operated independently of each other. A two-axis drive mechanism according to embodiments of the present disclosure can achieve continuous angulation ("lordosis") between the surfaces of the lower and upper shell members ranging from 0 to 30 degrees. It should be noted that the specific dimensions above are provided for a thorough understanding of various aspects of the present disclosure and are not intended to limit the scope of the claims.

[0032]

[0062] Biaxial adjustable interbody fusion device using modular fusion equipment

[0063] 2A-11B, an embodiment of a biaxial adjustable interbody fusion device, or apparatus 100, using a modular fusion apparatus according to the present disclosure will be described. The use of one or more modular fixation plates allows for attachment of a fixation assembly to the interbody fusion device in situ after the interbody fusion device has been adjusted to a desired configuration within the adjacent vertebrae, providing stabilization of the interbody fusion device and preventing movement of the interbody fusion device.

[0033]

[0064] 2A-2B, apparatus 100 generally comprises an interbody fusion device 10 and a fixation assembly 110 having one or more modular fixation plates 120, 140 and spinal anchor components 122 and 142. Interbody fusion device 10 may be the same as or similar to the exemplary biaxial interbody fusion device 10 described above in connection with FIGS. 1A-1C. Alternatively, interbody fusion device 10 may be any suitable biaxial adjustable interbody fusion device commercially available from a variety of manufacturers that may be further adapted or modified for use with fixation assembly 110.

[0034]

[0065] The fixation assembly 110 includes at least a first or lower fixation plate 120 and at least a first spinal anchor component or fastener 122. Additionally or alternatively, the fixation assembly 110 includes a second or upper fixation plate 140 and a second spinal anchor component or fastener 142. The term "fixation plate" as used herein includes a plate member and a plate assembly including the plate member and other parts or features assembled to the plate member. According to an embodiment of the present disclosure, the lower fixation plate 120 is modular and configured to be attachable to the interbody fusion device 10. The term "modular" as used herein refers to an embodiment of a fixation plate that is constructed as a unit that can be assembled to the interbody fusion device before or after implementation of the interbody fusion device. A modular fixation plate in a fixation assembly can be replaced by another modular fixation plate that is of the same structure as the plate being replaced. The lower fixation plate 120 can be provided with an aperture 124 configured to insert the first fastener 122 therethrough to the first or lower vertebral body. Similarly, in accordance with certain embodiments of the present disclosure, the upper fixation plate 140 is modular and configured to be attachable to the interbody fusion device 10. The upper fixation plate 140 can be provided with an aperture 144 configured to insert the second fastener 142 therethrough to the second or upper vertebral body. Exemplary fastener or anchor components suitable for the first fastener 122 and / or second fastener 142 include, but are not limited to, spinal expansion head screws, spinal locking screws, spinal self-locking screws, spinal shaft screws, spinal nails, spinal barbs, spinal hooks, or threaded or non-threaded members that can be anchored to a vertebral body. In the assembled view shown in FIG. 2B, the modular lower and upper fixation plates 120, 140 are attached to the interbody fusion device 10 with the first and second fasteners 122, 142 inserted through apertures in the lower and upper fixation plates 120, 140.It should be noted that in use, the modular lower fixation plate 120 and the modular upper fixation plate 140 may be attached to the interbody fusion device 10 in situ, i.e., after the interbody fusion device 10 has been positioned between adjacent vertebral bodies and adjusted to a desired configuration. The modular lower fixation plate 120 and the modular upper fixation plate 140 may also be attached to the interbody fusion device 10 prior to implementation of the interbody fusion device, if desired. Figures 10A-10B, which will be described in more detail below, illustrate that the modular upper fixation plate 140 and the modular lower fixation plate 120 are attached to the interbody fusion device 10 using surgical instrument 70 after the interbody fusion device 10 has been positioned and expanded and / or its lordotic adjustment to a suitable configuration between adjacent vertebrae.

[0035]

[0066] 3A-3D, a modular lower fixation plate 120 may be configured to be attachable to the interbody fusion device 10 and functions to provide stabilization of the interbody fusion device 10 within the adjacent vertebrae to prevent free movement of the interbody fusion device 10. According to certain embodiments of the present disclosure, the modular lower fixation plate 120 may be equipped with a geometric feature configured to be attached to the interbody fusion device 10 to prevent undesired rotation of a drive shaft, such as the posterior drive shaft 24 of the interbody fusion device 10. For example, the lower fixation plate 140 may have a male geometry 126 (FIG. 3C) configured to be inserted into a female geometry 27 within an end portion of the posterior drive shaft 24 of the interbody fusion device 10. For example, the male geometry 126 in the lower fixation plate 120 can have a male hexalobe feature that can tightly mate within the female hexalobe feature 27 in the end portion of the posterior drive shaft 24 to prevent undesired rotation of the drive shaft. A circular groove 127 around the male geometry 126 can be provided to receive the end portion of the posterior drive shaft 24. Figures 5A-5D and 6A-6D, described in more detail below, show the attachment of the lower fixation plate 120 to the interbody fusion device 10, where the male geometry 126 in the lower fixation plate 120 tightly mates within the female geometry 27 in the end portion of the posterior drive shaft 24.

[0036]

[0067] 3A-3D , the lower fixation plate 120 can be equipped with a geometry that allows for pivoting of the lower fixation plate 120 relative to the interbody fusion device 10 prior to mating a male geometry 126 in the lower fixation plate 120 within a female geometry 27 in an end portion of the posterior drive shaft 24 of the interbody fusion device 10. For example, the lower fixation plate 120 can have a channel geometry 128 configured to receive, for example, an end portion of a forward drive shaft 26 of the interbody fusion device 10. The channel geometry 128 allows the lower fixation plate 120 to "pivot" about the posterior drive shaft 24 without interfering with the forward drive shaft 26 by receiving the end portion of the forward drive shaft 26 within the channel geometry 128. This ability to pivot the inferior fixation plate 120 allows the position of the apertures 124 in the inferior fixation plate 120 to be adjusted, for example, according to the expansion and / or lordosis adjustment configuration of the interbody fusion device 10, thereby providing optimal positions of the apertures relative to the vertebral bodies for the fixators. Figures 7A-7D show the channel geometry 128 in the inferior fixation plate 120 attached to the interbody fusion device 10. Channel geometry 128 extends from a first end 129a to a second end 129b and receives an end portion of the forward drive shaft 26 within channel 128, thereby allowing the lower fixation plate 120 to "pivot" about the rear drive shaft 24, for example, at first end 129a when interbody fusion device 10 is in an expanded but non-lordosis adjusted configuration (FIGS. 7A-7B), at second end 129b when interbody fusion device 10 is in a large lordosis adjustment configuration (FIGS. 7C-7D), or anywhere in between when interbody fusion device 10 is in a configuration between the non-lordosis adjustment configuration and the large lordosis adjustment configuration.

[0037]

[0068] 3A-3D, the lower fixation plate 120 can have an attachment locking mechanism 130 that is engageable to lock the interbody fusion device 10 to secure attachment of the lower fixation plate 120 to the interbody fusion device 10. According to certain embodiments of the present disclosure, the attachment locking mechanism 130 can have a lock housing 130a, a rod 130b, a compression spring 130c loaded onto the rod 130b and retained within the lock housing 130a, and a latch 130d coupled to a distal end portion of the rod 130b. The proximal end portion of the rod 130b can have structure for receiving a driving tool to actuate the attachment locking mechanism 130. For example, the proximal end portion of the rod 130b can be equipped with a female hexalobular structure for receiving a Torx driver. In use, a user can push the rod 130b with a screwdriver to displace a latch 130d coupled to a distal end portion of the rod 130b, thereby allowing the latch 130d to rotate and engage a component within the interbody fusion device 10. A compression spring 130c loaded onto the rod 130b applies a force to the latch 130d, which upon release of the screwdriver, reinforces the attachment of the lower fixation plate 120 to the interbody fusion device 10 or locks the interbody fusion device 10 to the lower fixation plate 120. The lock housing 130a can be equipped with structure such as a screw thread configured to be connected to a surgical instrument. FIGS. 5A-5D show the latch 130d of the attachment lock mechanism 130 in an unlocked state. 6A-6C show the latch 130d of the mounting locking mechanism 130 in a locked state, where the latch 130d interferes with or holds in place the male threads in the end portion of the rear drive shaft 24, thereby preventing undesired rotation of the rear drive shaft 24.

[0038]

[0069] 3A-3D, the lower fixation plate 120 can have a fixture locking mechanism 132 configured to prevent the first fixture 122 from backing out of the aperture 124 after fixation. According to certain embodiments of the present disclosure, the fixture locking mechanism 132 can include a locking component 132a received in a recess 132b adjacent the fixture aperture 124 in the lower fixation plate 120, a compression spring 132c loaded onto a portion of the locking component 132a, and a retainer 132d connected to a portion of the locking component 132a. The retainer 132d holds the locking component 132a within the recess 132b via the compression spring loaded on the locking component 132a and is slidable with the locking bar 132a relative to the lower fixation plate 120. The fastener locking mechanism 132 has a locked state when the compression spring 132c is in a free or extended state to allow the locking component 132a to extend partially over the aperture 124 in the lower fixation plate 120, and an unlocked state when the compression spring 132c is in a compressed state to urge the locking component 132a away from the aperture 124 in the lower fixation plate 120. In use, when the fastener 122 is inserted into the aperture 124, the spring-loaded locking component 132a is urged away from the aperture 124, thereby allowing the fastener 122 to be driven or screwed into the vertebral body. When the fastener 122 is driven all the way so that the head of the fastener 122 is received in the countersink of the aperture 124 and is flush with or below the surface of the fixation plate 120, the spring-loaded locking component 132a springs back at least partially on the fastener head, thereby preventing the fastener 122 from backing out. The fastener locking mechanism 132 allows for "zero step" locking because the surgeon does not need any additional tools to cover the fastener head to keep it from backing out or any steps to be engaged by the fastener locking mechanism 132. For further clarity, Figures 15A-15B show an example fastener locking mechanism 242 in the fixation plate 220, which will be described later.The fastener locking mechanism 132 in the lower fixation plate 120 may be the same as or similar to the fastener locking mechanism 242 in the fixation plate 220 shown in Figures 15A-15B. Alternatively, the fastener locking mechanism 132 in the lower fixation plate 120 may be the same as or similar to the fastener locking mechanism 446 described in connection with Figures 27A-27B.

[0039]

[0070] 4A-4D, a modular upper fixation plate 140 may be configured to be attachable to the interbody fusion device 10 and function to stabilize the interbody fusion device 10 disposed within adjacent vertebrae to prevent movement of the interbody fusion device 10. According to certain embodiments of the present disclosure, the modular upper fixation plate 140 may have a protruding portion 146 configured to be insertable into the interbody fusion device 10. The protruding portion 146 may have a geometry configured to tightly mate with an internal component of the interbody fusion device 10 to limit undesired movement of the interbody fusion device 10. For example, the protruding portion 146 may have a geometry in the shape of a generally rectangular prism that may be tightly disposed within or between channels in the inner surface of the upper shell member 34. Thus, lateral, posterior, and / or anterior translation of the interbody fusion device 10 relative to the upper fixation plate 140 may be prevented or minimized. The protruding portion 146 may have any other suitable shape or configuration. Figures 8A-8B show the upper fixation plate 140 inserted into the interbody fusion device 10.

[0040]

[0071] 4A-4D, the upper fixation plate 140 can have a mounting locking mechanism 150 that is engageable to secure the attachment of the upper fixation plate 140 to the interbody fusion device 10 or to lock the interbody fusion device 10. The mounting locking mechanism 150 of the upper fixation plate 140 can be the same as or similar to the mounting locking mechanism 130 of the lower fixation plate 120 in many respects. Complementarily, the mounting locking mechanism 150 of the upper fixation plate 140 can have a lock housing 150a, a rod 150b, a compression spring 150c loaded onto the rod 150b and retained within the lock housing 150a, and a latch 150d coupled to a distal end portion of the rod 150b. FIG. 8A shows the mounting locking mechanism 150 in an unlocked state, where the upper fixation plate 140 has been inserted into the interbody fusion device 10. FIG. 8B illustrates the mounting locking mechanism 150 in a locked state, with the upper fixation plate 140 inserted and locked into the interbody fusion device 10.

[0041]

[0072] 4A-4D, the upper fixation plate 140 may further include a fastener locking mechanism 152 configured to prevent backout of the second fastener 142 from the aperture 144 in the upper fixation plate 140. As the fastener locking mechanism 152 of the upper fixation plate 140 is in many respects the same as or similar to the fastener locking mechanism 132 of the lower fixation plate 120, a detailed description thereof will be omitted herein.

[0042]

[0073] 2A-2B, the modular lower fixation plate 120 and upper fixation plate 140 are shaped and / or sized or otherwise configured to allow for at least partial interdigitation of the two fixation plates when attached to the interbody fusion device 10. For example, the lower fixation plate 120 can include an edge portion having a concave profile 121 and the upper fixation plate 140 can include an edge portion having a convex profile 141. The concave edge portion 121 of the lower fixation plate 120 and the convex edge portion 141 of the upper fixation plate 140 allow for at least partial interdigitation, thereby allowing for attachment of the lower fixation plate 120 and the upper fixation plate 140 to the interbody fusion device 10 when the interbody fusion device 10 is in a less contracted or expanded configuration. Additionally, the rounded or scalloped profile of the concave edge portion 121 of the lower fixation plate 120 and the convex edge portion 141 of the upper fixation plate 140 allows for the lower fixation plate 120 and the upper fixation plate 140 to be attached to the interbody fusion device 10 when the interbody fusion device 10 is in a lordosis-adjusted configuration or a large lordosis-adjusted configuration (e.g., 20 to 30 degrees of lordosis). Figures 9A-9C show the attachment of the lower fixation plate 120 and upper fixation plate 140 and fasteners 122, 142 to the interbody fusion device 10 in the contracted, fully expanded, and lordosis-adjusted configurations, respectively. For ease of explanation and illustration, the dimensions set forth below refer to an embodiment in which the biaxial adjustable interbody fusion 10 is placed between adjacent vertebrae via a lateral lumbar interbody fusion (LLIF) procedure and is expanded and / or lordotically adjusted by operating two actuating mechanisms along the anterior and / or posterior sides of the patient, respectively, to achieve a configuration appropriate for the patient's sagittal balance.Those skilled in the art will recognize that the interbody fusion device may also be placed via an anterior lumbar interbody fusion (ALIF) procedure or a posterior lumbar interbody fusion (PLIF) procedure and expanded or adjusted in lordosis by operating the drive mechanism along the lateral and / or contralateral side of the patient to achieve the patient's desired sagittal balance or to correct the patient's sagittal imbalance.

[0043]

[0074] FIG. 9A shows an embodiment in which the interbody fusion device 10 is contracted to a configuration having an anterior height ("anterior height") that is 8.4 mm, a posterior height ("posterior height") that is 8.4 mm, and an angle between the upper and lower shell members ("lordosis") that is 0 degrees. The concave and convex profiles of the edge portions allow the modular lower and upper fixation plates 120, 140, respectively, to be inserted and attached to the interbody fusion device 10. FIG. 9B shows an embodiment in which the interbody fusion device 10 is in a fully expanded configuration having an anterior height of 16.1 mm, a posterior height of 16.1 mm, and a lordosis of 0 degrees. The modular lower and upper fixation plates 120, 140 attached to the interbody fusion device 10 can stabilize the interbody fusion device 10 in the fully expanded configuration and prevent it from moving. 9C shows an embodiment in which the interbody fusion device 10 is in a large lordosis adjustment configuration with an anterior height of 17.1 mm, a posterior height of 7.2 mm, and a lordosis of 30 degrees. The modular lower fixation plate 120 and upper fixation plate 140 attached to the interbody fusion device 10 can stabilize the interbody fusion device 10 in the large lordosis adjustment configuration and prevent it from drifting. Comparing FIG. 9C to FIG. 9B, the channel geometry in the lower fixation plate 120 allows the lower fixation plate 120 to be "pivoted" about the posterior drive shaft 24 prior to final attachment (note the different location of the anterior drive shaft 26 within the channel geometry in the lower fixation plate 120), thereby allowing angulation of the lower fixation plate 120 relative to the interbody fusion device 10 and providing optimal location of the apertures in the lower fixation plate 120 and thus optimal fastener paths. Additionally, the apertures in the lower fixation plate 120 and the upper fixation plate 140 may be configured or machined to allow for angling the axes of the apertures from the lower fixation plate and the upper fixation plate, respectively, as will be described in more detail in connection with Figures 16A-16B.The angled apertures in the lower and upper fixation plates 120, 140, as well as the choice of fasteners (e.g., the head portions of the fasteners are rounded), allow the fasteners 122, 142 to have variable paths, such as 0 degrees to 15 degrees caudal or cephalad, as shown in Figures 9A-9C, respectively. It should be noted that the specific dimensions and angles presented above are provided for a thorough understanding of various embodiments of the present disclosure, but are not intended to limit the scope of the claims.

[0044]

[0075] The biaxial adjustable interbody fusion device or apparatus 100 using the modular fusion apparatus may be used to treat a variety of spinal disorders, including, but not limited to, degenerative disc disease (DDD), spondylolisthesis, and posterior spondylolisthesis (Grade 1). In use, as shown in FIGS. 10A-10B, the modular lower and upper fixation plates 120, 140 may be inserted and attached to the interbody fusion device 10 in situ. For example, the interbody fusion device 10 in a collapsed configuration may first be inserted and positioned between adjacent vertebrae 72, 74 using surgical instruments 70 via a suitable surgical procedure. Suitable surgical procedures for placing the interbody fusion device 10 include a lateral lumbar interbody fusion (LLIF) procedure, an anterior lumbar interbody fusion (ALIF) procedure, a posterior lumbar interbody fusion (PLIF) procedure, and any other suitable surgical procedure performed within the lumbar spine or other regions of the spinal column. Various suitable surgical instruments are described in U.S. patent application Ser. No. 15 / 661,435, filed July 17, 2017, entitled "Surgical Operating Instrument for Expandable and Adjustable Lordosis Interbody Fusion Systems," and U.S. patent application Ser. No. 16 / 035,637, filed July 15, 2018, entitled "Surgical Operating Instrument for Expandable and Adjustable Lordosis Interbody Fusion Systems," the entire disclosures of which are incorporated herein by reference. Interbody fusion device 10 may be expanded and / or lordotically adjusted using surgical instrument 70 to form the appropriate configuration between adjacent vertebrae 72, 74. For example, a surgical instrument 70 can be connected to the interbody fusion device 10 via male threads 25 on the end portions of the posterior and anterior drive shafts 24, 26, and by engaging female features 27 with the end portions of the posterior and anterior drive shafts 24, 26 (FIG. 1A), the interbody fusion device 10 can be expanded or its lordosis can be adjusted.

[0045]

[0076] The modular upper fixation plate 140 may then be introduced to the target area and attached to the interbody fusion device 10 via the same surgical approach as for placing the interbody fusion device 10. According to embodiments of the present disclosure, the surgical instrument 70 used to place and operate the interbody fusion device 10 may also be used to insert and attach the modular upper fixation plate 140. For example, a surgeon may connect the upper fixation plate 140 to the surgical instrument 70 via threads provided at the lock housing 150a of the mounting lock mechanism 150 (FIGS. 4A-4D), introduce the upper fixation plate 140 to the target area via the same surgical approach, and insert the protruding portion of the upper fixation plate 140 into the interbody fusion device 10. The interbody fusion device 10 may be locked to the upper fixation plate 140 by actuating the mounting lock mechanism 150 using the surgical instrument 70.

[0046]

[0077] After or before inserting and attaching the modular upper fixation plate 140, the modular lower fixation plate 120 may be introduced into the target area and attached to the interbody fusion device 10 using the same surgical instruments 70 via the same surgical approach as placing the interbody fusion device 10. For example, a surgeon may connect the lower fixation plate 120 to the surgical instruments 70 via threads provided at the lock housing 130a of the lock attachment mechanism 130 (FIGS. 3A-3D) and introduce the lower fixation plate 120 into the target area via the same surgical approach, with the male geometry 126 in the lower fixation plate 120 being inserted into the female geometry 27 in the end portion of the posterior drive shaft 24. Optionally, prior to final engagement of the male geometry 126 of the lower fixation plate 120 with the female geometry 27 of the posterior drive shaft 24, the lower fixation plate 120 can be pivoted about the posterior drive shaft 24 to adjust or provide an optimal location of the aperture 124 in the lower fixation plate 120 for optimal fastener path. The interbody fusion device 10 can then be further locked to the lower fixation plate 120 by actuating the attachment locking mechanism 130 using the surgical instrument 70.

[0047]

[0078] Fasteners 122, 142, such as spinal screws, may then be inserted through apertures in the upper and lower fixation plates 120, 140 and screwed into the first and second vertebral bodies 72, 74, respectively. When the fasteners 122, 142 are driven all the way so that the heads of the fasteners are received in the countersinks of the apertures in the fixation plates, the fastener locking mechanisms in the upper and lower fixation plates 120, 140 automatically activate and prevent backout of the fasteners 122, 142. The interbody fusion device 10 may be stabilized and prevented from free movement within the vertebral bodies 72, 74, as shown in FIGS. 11A-11B.

[0048]

[0079] 2A-11B, a biaxial adjustable interbody fusion device using a modular fusion apparatus 100 is described. Beneficially, the interbody fusion device using the modular fusion apparatus 100 can provide stabilization of the interbody fusion device in a highly expanded and / or highly lordotic configuration and prevent its drift, thereby facilitating safe fusion between adjacent vertebral bodies. The modular upper and lower fixation plates allow for in situ attachment of either or both plates to any suitable size or configuration of interbody fusion device after adjustment of the interbody fusion device, or even the option of attachment to the interbody fusion device prior to implementation. The modular fixation plates are insertable and attachable to the interbody fusion device via a single surgical approach and in a single patient position, thereby minimizing disruption to the patient's anatomy. Additionally, this modular design gives the surgeon the option to use the fixation assembly during surgery or terminate if desired after adding an interbody construct. Modular lower fixation plate 120 and upper fixation plate 140 follow the anterior and posterior angulation of lower and upper shell members 32, 34 of interbody fusion device 10, which is 0 degrees to 15 degrees, respectively, i.e., 0 degrees to 30 degrees measured from the center of the modular lower fixation plate to the center of the modular upper fixation plate, thereby allowing for desired screw trajectory and placement into cortical bone in the desired manner.

[0049]

[0080] Interbody fusion devices using fusion apparatus 100 allow surgeons to place interbody fusion devices in sophisticated configurations, particularly in highly expanded configurations with any height and in large lordotic adjustment configurations with any angle between 20°-30° in any patient, without further disruption to the patient's anatomy that would be caused by additional surgery as would be required with separate screw-plate systems. Although kyphosis (negative lordotic) adjustment may not be desired, interbody fusion devices using fusion apparatus 100 have the ability to adjust to kyphosis or large kyphotic angle configurations for the lumbosacral segment of the spine. Thus, interbody fusion devices using fusion apparatus 100 can achieve complete personalization for the patient, allowing the surgeon to adjust the interbody fusion device to any unique height and / or angle (e.g., 23.4°) required for the patient's spinal balance profile. Traditional techniques only allow for the placement of interbody fusion devices in a few different lordotic configurations, such as 20°, 25°, and 30°, and require the use of a separate screw-plate system through additional surgery to stabilize the fusion device in the lordotic configuration.

[0050]

[0081] Additionally, interbody fusion devices using the fusion apparatus 100 can improve surgical efficiency. Traditionally, determining the size of the implant required for a particular patient requires the surgeon to perform high impact testing or implant sizing. According to embodiments of the present disclosure, the interbody fusion device can start at a smaller contracted height and can be increased in height in situ. This can simplify or significantly reduce the testing process, thereby reducing the impact of imprecision and inaccuracies associated with the testing process. Modular fixation plates can be used for large lordosis configurations, thereby reducing the need to place additional fixation plates and bone screw sets that are separate from the interbody fusion device. Using modular fixation plates reduces confusion about the patient's anatomy. Once the surgeon has adjusted the interbody fusion device to match the patient's unique spinal profile, e.g., sagittal balance profile, disc height, and lordosis, modular fixation plates can be inserted through the same surgical approach and attached to the fusion device, thereby allowing for anchoring of the fusion device to the vertebral bodies without the need for an additional surgical approach to posteriorly place a separate plate-screw fixation system into the spine.

[0051]

[0082] Additionally, this modular design of the fixation assembly provides benefits related to manufacturing and hospital management, which can reduce the variety of product configurations. A single set of lower and upper fixation plates can work with any size and configuration of biaxial interbody fusion devices, thereby significantly reducing manufacturing and operational costs. The use of a single set of lower and upper fixation plates with any size and configuration of biaxial interbody fusion devices simplifies tracking needs by requiring only one set of fixation plates to be tracked in the hospital or operating room.

[0052]

[0083] Dual-axis adjustable articulated spinal system

[0084] 12A-19B, an exemplary biaxial adjustable spinal system 200 according to an embodiment of the present disclosure will now be described. The use of a single fixation plate in the spinal system allows for the attachment of a fixation assembly to the interbody fusion device in situ after the device has been adjusted to a desired configuration between adjacent vertebrae. The single fixation plate may be constructed from a material of sufficient strength, such as titanium, stainless steel, or other metal or metal alloy, to provide stabilization of the interbody fusion device to prevent its movement as well as provide a corrective support or captive fusion device. As used herein, the term "captive fusion device" refers to an embodiment of a single fixation plate that functions as an orthopedic device that can hold adjacent vertebrae in position or can fix the movement of adjacent vertebrae until arthrodesis (osteofusion) occurs.

[0053]

[0085] 12A-12E, a spinal system 200 includes an interbody fusion device 10 and a fixation assembly 210. The interbody fusion device 10 may be the same as or similar to the device 10 described above in connection with FIGS. 1A-1C. Alternatively, the interbody fusion device 10 may be any suitable biaxial adjustable interbody fusion device commercially available from a variety of manufacturers that may be further adapted or modified for use with the fixation assembly 210.

[0054]

[0086] The fixation assembly 210 includes a single fixation plate 220, at least a first fastener 222 and a second fastener 224. The single fixation plate 220 is configured to be attachable to the interbody fusion device 10. The single fixation plate 220 includes at least a first aperture 226 configured to insert a first fastener 226 therethrough to be secured to a first vertebral body, and a second aperture 228 configured to insert a second fastener therethrough to be secured to a second vertebral body. The term "single" as used herein refers to one fixation plate that includes at least two apertures for inserting at least two fasteners that can stabilize the interbody fusion device between two adjacent vertebral bodies. However, the use of the term "single" does not exclude other parts that are assembled to the fixation plate to perform other functions, such as locking. The term "fixation plate" as used herein also includes a plate member and a plate assembly that includes a plate member and other parts or features that are assembled to the plate member. Although two fasteners and two apertures in a single fixation plate are shown for illustrative purposes, other embodiments may have three or more fasteners and three or more apertures in the fixation plate. Additionally, Figures 12C-12D show an assembled view of a spinal system 200 in which a single fixation plate 220 is attached to an interbody fusion device 10 with a first fastener 222 and a second fastener 224 inserted through apertures in the fixation plate. Note that in use, the single fixation plate 220 may be attached to the interbody fusion device 10 in situ or the interbody fusion device 10 has been inserted into a patient and positioned between adjacent vertebral bodies. Additionally, if the interbody fusion device is adjusted prior to implementation, a single fixation plate 220 may be attached to the interbody fusion device 10 prior to implementation if desired.FIG. 18A, which will be described in more detail below, shows that after the interbody fusion device has been positioned and expanded and / or its lordosis adjusted to the proper configuration between the adjacent vertebrae, a single fixation plate 220 is inserted into the patient and attached to the interbody fusion device with surgical instruments.

[0055]

[0087] 13A-13F, a single fixation plate 220 may be configured to be attachable to the interbody fusion device 10. For example, the single fixation plate 220 may be equipped with a geometric structure configured to be attached to the interbody fusion device 10 and to prevent undesired rotation of the drive shafts 24 and 26 of the interbody fusion device 10. According to certain embodiments of the present disclosure, the back side single fixation plate 220 may have a first male geometry 230 and a second male geometry 232 spaced apart from one another (FIGS. 13C and 13F). The first male geometry 230 and the second male geometry 232 may be configured to be inserted into female geometries 27 within respective end portions of the first (e.g., posterior) and second (e.g., anterior) drive shafts 24 and 26 of the interbody fusion device 10. For example, the first male geometry 230 and the second male geometry 232 can have male hexalobular structures that can tightly mate in female hexalobular structures 27 in the end portions of the first drive shaft 24 and the second drive shaft 26 to prevent undesired rotation of the first drive shaft 24 and the second drive shaft 26. The first and second male geometries can also have other mating structures. The above hexalobular examples are provided for illustrative purposes. Around each of the first male geometry 230 and the second male geometry 232, a circular groove 231, 233 can be provided to receive or accommodate the end portions of the first drive shaft 24 and the second drive shaft 26 of the interbody fusion device 10 when a single fixation plate 220 is attached to the interbody fusion device 10. FIG. 12E illustrates the attachment of a single fixation plate 220 to the interbody fusion device 10, where the first male geometry 230 and the second male geometry 232 in the single fixation plate 220 are received within the female geometry 27 in the end portions of the first drive shaft 24 and the second drive shaft 26, respectively, and the end portions of the first drive shaft 24 and the second drive shaft 26 fit into circular grooves in the single fixation plate 230.

[0056]

[0088] 13C-13F, the single fixation plate 220 may alternatively or additionally have a protruding portion 234 configured to be insertable into the interbody fusion device 10 to stabilize and prevent free movement of the interbody fusion device 10 disposed between adjacent vertebrae. According to certain embodiments of the present disclosure, the protruding portion 234 in the single fixation plate 220 may have a geometry configured to tightly mate with an internal component of the interbody fusion device 10 to limit undesired movement of the interbody fusion device 10. For example, the protruding portion 234 may have a geometry in the shape of a generally rectangular prism that may be tightly inserted into the angled geometry of the thrust bearing 60 (FIG. 1A) of the interbody fusion device 10. Thus, undesired lateral, posterior, and anterior translation of the interbody fusion device 10 may be prevented or minimized. The protruding portion 234 may be any other suitable shape or form, such as a cube, a half cylinder, or a polygonal prism shape. Figures 14A-14B show the protruding portion 234 of a single fixation plate 220 inserted into the interbody fusion device 10 and the attachment locking mechanism 240 in an unlocked state (Figure 14A) and a locked state (Figure 14B), which are described further below.

[0057]

[0089] 13A-13F, the single fixation plate 220 can have a mounting lock mechanism 240 that is engageable to lock the interbody fusion device 10 or secure the mounting of the single fixation plate 220 of the interbody fusion device 10. According to certain embodiments of the present disclosure, the mounting lock mechanism 240 can be the same as or similar to the mounting lock mechanism 130 shown in FIGS. 3A-3D or the mounting lock mechanism 150 shown in FIGS. 4A-4D. In a complementary manner, the mounting lock mechanism 240 in the single fixation plate 220 can have a lock housing 240a, a rod 240b, a compression spring 240c loaded on the rod 240b and held within the lock housing 240a, and a latch 240d coupled to a distal end portion of the rod. A proximal end portion of the lock rod 240b can have a structure for receiving a driving tool to actuate the mounting lock mechanism 240. For example, a proximal end portion of the rod 240b can be equipped with a female hexalobe structure for receiving a driver having a male hexalobe structure. In use, a user can press the rod 240b with a driver to displace a latch 240d coupled to a distal end portion of the rod 240b, thereby allowing the latch to rotate and engage a component within the interbody fusion device 10. A compression spring 240c loaded on the rod 240b applies a force to the latch 240d, which upon release of the driver, reinforces the attachment of the lower fixation plate 220 to the interbody fusion device 10 or locks the interbody fusion device 10 to the single fixation plate 220. The housing 240a of the mounting lock mechanism 240 can be equipped with structure, such as threads, configured to be connected to a surgical instrument to actuate the mounting lock mechanism 240 and / or to position the single fixation plate in the patient's anatomy. Figure 14A illustrates the mounting lock mechanism 240 in an unlocked state, where the latch 240d is in an unlocked position, and Figure 14B illustrates the mounting lock mechanism 240 in a locked state, where the latch 240d is in a locked position where it engages a component of the interbody fusion device 10 (e.g., a thrust bearing).

[0058]

[0090] 13A-13B, the single fixation plate 220 can further include a first fixation mechanism 242 and a second fixation mechanism 244. The first and second fixation mechanisms in the single fixation plate 220 can be the same as or similar to the fixation mechanism 132 shown in FIGS. 3A-3D and the fixation mechanism 152 shown in FIGS. 4A-4D. Complementarily, the first fixation mechanism 242 in the single fixation plate 220 can include a locking component 242a received in a recess 242b adjacent to the first aperture 226, a compression spring 242c loaded onto a portion of the locking component 242a, and a retainer 242d connected to a portion of the locking component 242a. A retainer 242d holds the locking component 242a in the recess 242b via a compression spring loaded on the locking component 242a and is slidable with the locking component 242a relative to the single fixation plate 220, thereby allowing the locking component 242a to extend over and / or retract from the aperture 226 in use. The second fixation locking mechanism 244 may be the same as or similar to the first fixation locking mechanism 242. Alternatively, the first and second fixation locking mechanisms 242, 244 are the same as or similar to the fixation locking mechanisms 426 and 446 in the fixation plates 420 and 440 described in connection with Figures 27A-27B.

[0059]

[0091] 15A-15B more clearly depict some aspects of the first fastener locking mechanism 242 in the single fixation plate 220. The compressed and extended (free) states of the compression spring allow the spring-loaded locking component 242a to have an unlocked / open position and a locked position, respectively. In the extended or free state of the compression spring, the locking component 242a extends partially over the aperture 226 in the fixation plate 220. When the fastener 222 is inserted into the aperture 226 by a driver, the spring-loaded locking component 242a is forced away from the aperture 226, thereby allowing the fastener 222 to be secured, e.g., screwed, into the vertebral body. Once the fastener 222 is threaded all the way in and the head of the fastener 222 is flush with or below the surface of the fixation plate 220, the spring-loaded locking component 242a at least partially springs back on the fastener head, thereby preventing backout of the fastener 222. The fastener locking mechanism 242 of the present disclosure allows for "zero step" locking because the surgeon does not need any surgical tools to cover the fastener head to keep it from backing out, e.g., from dislodging it from a vertebral body, or any steps to engage the fastener locking mechanism 242.

[0060]

[0092] 16A and 16B show that the first aperture 226 and the second aperture 268 in the single fixation plate 220 can be angled. For example, the centerline 227 of the first aperture 226 can be angled from 0 degrees to 15 degrees relative to a reference plane, such as a reference plane that is parallel to the surface of the fixation plate. Similarly, the centerline 229 of the second aperture 228 can be angled from 0 degrees to 15 degrees relative to a reference plane, such as a reference plane that is parallel to the surface of the single fixation plate. The angled apertures allow the fasteners inserted therethrough to have an angled path, thereby optimizing the effect of the fasteners against the vertebral bodies. The first aperture 226 and the second aperture 228 allow the first fasteners 222 and the second fasteners 224 to have an angle of 0 degrees to 15 degrees, for example, in a caudal or cephalad direction, respectively, or in any other direction. The first aperture 226 and the second aperture 228 can have counterbore or countersink portions configured to receive the heads of the first and second fasteners. The heads of the fasteners can have a spherical shape as shown in Figures 15A-15B, or any other suitable shape, such as a tapered or cylindrical shape. Examples of fasteners include, but are not limited to, spinal expansion head screws, spinal locking screws, spinal self-locking screws, spinal shaft screws, spinal nails, spinal barbs, spinal hooks, and any other threaded or non-threaded members.

[0061]

[0093] 17A-17C show a single fixation plate 220 attached to the interbody fusion device 10 in various configurations, including an expanded configuration, a fully expanded configuration, and a lordotic or hyperlordotic configuration. Although kyphosis (negative lordosis) adjustment may not be desired for the lumbosacral segment of the spine, the interbody fusion device 10 may be connected to a single fixation plate assembly in a kyphotic or hyperlordotic angle configuration. As an example when the interbody fusion device 10 is placed between adjacent vertebrae via a lateral surgical procedure, FIG. 17A shows a single fixation plate 220 attached to the interbody fusion device 10 in a contracted configuration having an anterior height of 8.4 mm, a posterior height of 8.4 mm, and a lordosis of 0 degrees. FIG 17B illustrates an embodiment where a single fixation plate 220 is attached to the interbody fusion device 10 in a fully expanded configuration with an anterior height of 16.1 mm, a posterior height of 16.1 mm, and a lordosis of 0 degrees. FIG 17C illustrates an embodiment where a single fixation plate 220 is attached to the interbody fusion device 10 in a large lordosis adjusted configuration with an anterior height of 17.1 mm, a posterior height of 7.2 mm, and a lordosis of 30 degrees. The angled first and second apertures in the single fixation plate 220 allow for screw angulation of up to 15 degrees in the caudal and cephalad directions, respectively, as shown in FIGS 17B-17C.

[0062]

[0094] The biaxial adjustable spinal system 200 may be used to treat a variety of spinal disorders, including, but not limited to, degenerative disc disease (DDD), spondylolisthesis, posterior spondylolisthesis, trauma, tumors, deformity, nonunion, and previously failed fusion procedures. In use, as shown in FIG. 18, a single fixation plate 220 is inserted and attached to the interbody fusion device 10 in situ. For example, the interbody fusion device 10 in a collapsed configuration may first be inserted and positioned between adjacent vertebrae 72, 74 using surgical instruments 70 via a suitable surgical procedure. Suitable surgical procedures for introducing the interbody fusion device 10 into the patient's anatomy include a lateral lumbar interbody fusion (LLIF) procedure, an anterior lumbar interbody fusion (ALIF) procedure, a posterior lumbar interbody fusion (PLIF) procedure, and any other suitable surgical procedure performed within the lumbar spine or other regions of the spinal column. Various suitable surgical instruments are described in U.S. patent application Ser. No. 15 / 661,435, filed July 17, 2017, entitled "Surgical Operating Instrument for Expandable and Adjustable Lordosis Interbody Fusion Systems," and U.S. patent application Ser. No. 16 / 035,637, filed July 15, 2018, entitled "Surgical Operating Instrument for Expandable and Adjustable Lordosis Interbody Fusion Systems," all of which are incorporated herein by reference in their entirety. The interbody fusion device 10 may be expanded and / or its lordosis adjusted using the surgical instrument 70 to form the appropriate configuration between adjacent vertebrae 72, 74. For example, a surgical instrument 70 can be connected to the interbody fusion device 10 via male threads 25 on the end portions of the posterior and anterior drive shafts 24, 26, and by engaging female features 27 with the end portions of the posterior and anterior drive shafts 24, 26 (FIG. 1A), the interbody fusion device 10 can be expanded or its lordosis can be adjusted.The interbody fusion device 10 may be expanded and / or have its lordosis adjusted to a configuration suitable for treating the patient.

[0063]

[0095] The single fixation plate 220 may then be introduced to the target area and attached to the interbody fusion device 10 via the same surgical approach as for inserting and positioning the interbody fusion device 10. According to embodiments of the present disclosure, the surgical instrument 70 used to position and operate the interbody fusion device 10 may also be used to insert and attach the single fixation plate 220. For example, a surgeon may connect the single fixation plate 220 to the surgical instrument 70 via threads provided at the lock housing 240a of the lock attachment mechanism 240, the single fixation plate 220 may be introduced to the target area via the same surgical procedure, the first male geometry 230 and the second male geometry 232 may be aligned with the female geometry 27 in the end portions of the posterior drive shafts 24 and 26 of the interbody fusion device 10, and the single fixation plate 220 may be inserted to the interbody fusion device 10. The interbody fusion device 10 may further be locked to the single fixation plate 220 by actuating the attachment locking mechanism 240 using the surgical instrument 70 .

[0064]

[0096] Fasteners 222, 224, such as bone screws, may then be inserted through apertures in the single fixation plate 220 and screwed into the first vertebral body 72 and the second vertebral body 74, respectively. When the fasteners 222, 224 are driven all the way to receive the heads of the fasteners 222, 224 within the single fixation plate 220, the fastener locking mechanisms 242, 244 within the single fixation plate 220 are automatically activated to prevent backing out of the fasteners 222, 224. The interbody fusion device 10 may be stabilized and prevented from moving within the vertebral bodies 72, 74, as shown in FIGS. 19A-19B. Additionally, the single fixation plate 220 may be constructed from a material having sufficient strength, such as stainless steel, or other metal or metal alloy, to provide a captive fusion device that holds the adjacent vertebral bodies 72 and 74 in place or prevents movement of the adjacent vertebrae to facilitate a safe body fusion.

[0065]

[0097] In relation to Figs. 12A-19B, an embodiment of a biaxial adjustable spinal system 200 with a single fixation plate is described. Beneficially, the spinal system 200 can provide stabilization and facilitate fusion between adjacent vertebral bodies without the need for additional supplemental posterior fixation devices when treating degenerative disc disease (DDD), spondylolisthesis, and posterior spondylolisthesis (Grade 1). The single fixation plate can be constructed with sufficient strength to provide corrective support or supplemental fixation devices. The single fixation plate 220 can be implantable and configurable to be attached to an interbody fusion device via a single surgical approach and in a single patient position, thereby minimizing disruption to the patient's anatomy. Geometry such as a male geometry in the single fixation plate can function as an auxiliary safety lock for the biaxial interbody fusion device. The single fixation plate can be attached to interbody fusion devices of any footprint and configuration.

[0066]

[0098] As with other embodiments of the device 100, the spinal system 200 allows the surgeon to place the interbody fusion device in sophisticated configurations, particularly in highly expanded configurations, with any height and any angle between 20° and 30° in any patient in a large lordotic configuration, without further disruption to the patient's anatomy through additional surgery as would be required with a separate screw-and-plate system. Thus, the spinal system 200 allows for complete personalization for the patient, allowing the surgeon to adjust the interbody fusion device to any unique height and / or angle (e.g., 23.4°) required for the patient's spinal balance profile. Conventional techniques may only allow the interbody fusion device to be set in a few predefined lordotic configurations, such as 20°, 25°, 30°, etc., and require the use of a separate screw-and-plate system through additional surgery to stabilize the fusion device in the lordotic configuration.

[0067]

[0099] Additionally, the spinal system 200 can improve surgical efficiency. Traditionally, determining the size of implant required for a particular patient requires the surgeon to perform impactful testing or implant sizing. According to embodiments of the present disclosure, the interbody fusion device can start at a smaller retracted height and can be increased in height in situ. This can simplify or significantly reduce the testing process, thereby reducing the impact of imprecision and inaccuracies associated with the testing process. Once the surgeon has adjusted the interbody fusion device to match the patient's unique spinal profile, e.g., sagittal balance profile, disc height, and lordosis, a single fixation plate can be inserted and attached to the interbody fusion device via the same surgical approach, thereby allowing the fusion device to be secured to the vertebrae, thereby reducing disruption to the patient's anatomy. Additionally, a single fixation plate can provide a complementary fusion device, eliminating the need for a separate plate-screw fixation system via a separate surgical approach to the patient's spine.

[0068]

[0100] Additionally, spine system 200 provides benefits related to manufacturing and hospital management, which can reduce the variety of product configurations. A single set of fixation plates can work with any size and any manufactured configuration of bi-axial adjustable interbody fusion devices, thereby significantly reducing manufacturing and operational costs. The use of a single set of fixation plates with any bi-axial interbody fusion device size and configuration simplifies tracking needs by requiring a hospital or operating room to track only one set of fixation plates.

[0069]

[0101] Dual axis adjustable variable spine system

[0102] 20A-25B, an exemplary biaxial adjustable spinal system 300 according to an embodiment of the present disclosure will now be described. The spinal system 300 shown in FIGS. 20A-25B is similar in many respects to the spinal system 200 described above in connection with FIGS. 12A-19B. For example, the spinal system 300 includes a single fixation plate for attachment to an interbody fusion device in situ after adjusting the interbody fusion device to a desired configuration within the adjacent vertebrae. The single fixation plate may be constructed from a material having sufficient strength to provide a complementary fusion device in addition to providing stabilization of the interbody fusion device to prevent its movement. Several unique aspects of the spinal system 300 are described below.

[0070]

[0103] 20A-20D, a spinal system 300 includes an interbody fusion device 10 and a fixation assembly 310. The interbody fusion device 10 may be the same as or similar to the device 10 described above in connection with FIGS. 1A-1C. The fixation assembly 310 includes a single fixation plate 320, at least a first fastener 322, and at least a second fastener 324. The single fixation plate 310 includes at least a first aperture 326 configured to insert the first fastener 322 therethrough to be secured to a first vertebral body, and a second aperture 328 configured to insert the second fastener 324 therethrough to be secured to a second vertebral body. The single fixation plate 320 is configured to be insertable into the interbody fusion device 10, thereby allowing the single fixation plate 320 to be attached to the interbody fusion device 10 in situ. Additionally, if the interbody fusion device is adjusted prior to installation, the single fixation plate 320 may be attached to the interbody fusion device 10 prior to installation if desired. The single fixation plate 320 may have an attachment locking mechanism 340 configured to secure the attachment of the single fixation plate 320 to the interbody fusion device 10. According to certain embodiments, the single fixation plate 320 is rotatable relative to the interbody fusion device 10 in either a clockwise or counterclockwise direction, as shown in FIG. 20D. This ability to rotate the single fixation plate 320 relative to the interbody fusion device 10 allows the location of the first aperture 326 and the second aperture 328 to be adjusted relative to the vertebral body, thereby optimizing the path of the fastener to increase its effect relative to the vertebral body.

[0071]

[0104] 21A-21F, a single fixation plate 320 is in many respects similar to the single fixation plate 210 described above in connection with FIGs. 13A-13F. For example, the single fixation plate 320 can have a mounting locking mechanism 340, a first fastener locking mechanism 342, and a second fastener locking mechanism 344. The configuration and operation of the mounting locking mechanism 340 and fastener locking mechanisms 342 and 344 are the same as or similar to the mounting locking mechanism 240 and fastener locking mechanisms 242 and 244 in the single fixation plate 210 shown in FIGs. 13A-13F. Accordingly, for the sake of clarity, a detailed description thereof is omitted herein.

[0072]

[0105] 21C-21F, the single fixation plate 320 may further include a protruding portion 334 configured to allow for insertion into or attachment of the single fixation plate 320 to the interbody fusion device 10, thereby stabilizing and / or preventing movement of the interbody fusion device 10 disposed between adjacent vertebrae. The attachment of the single fixation plate 320 to the interbody fusion device 10 limits undesirable translation of the interbody fusion device 10 in either the lateral, anterior, or posterior directions. The attachment of the single fixation plate 320 to the interbody fusion device 10 may be secured or locked by an attachment locking mechanism 340, as shown in FIGS. 22A-22B. FIG. 22A illustrates the attachment of the single fixation plate 320 to the interbody fusion device 10 and the attachment locking mechanism 340 in an unlocked state. FIG. 22B shows the attachment of a single fixation plate 320 to the interbody fusion device 10 and the attachment lock mechanism 340 in a locked state, where the latch 340d of the attachment lock mechanism 340 engages a component (e.g., a thrust bearing) within the interbody fusion device 10.

[0073]

[0106] According to certain embodiments of the present disclosure, the protruding portion 334 is configured to allow the single fixation plate 320 to be rotatable relative to the interbody fusion device 10. For example, the protruding portion 334 can have a generally semi-cylindrical geometry that can be received within an internal component, such as a channel geometry that is incorporated into the inner surface of the upper shell member 34 of the interbody fusion device 10. The semi-cylindrical geometry of the protruding portion 334 allows the single fixation plate 320 to be rotatable relative to the interbody fusion device 10, thereby allowing the orientation or angle of the single fixation plate 320 to be adjusted before being fixed to the vertebral body. According to certain embodiments of the present disclosure, the single fixation plate 320 can be rotated clockwise or counterclockwise at an angle of 0 degrees to 11 degrees relative to an imaginary plane that encompasses the first drive shaft 24 and the second drive shaft 26. FIG. 23A is an end view illustrating the angulation of the single fixation plate 320 relative to the interbody fusion device 10. 23B is a cross-sectional view showing the angulation of the single fixation plate 320 relative to the interbody fusion device 10. The lateral side of the single fixation plate 320 may be configured to receive the first and second drive shafts 24, 26 of the interbody fusion device 10 when rotating the single fixation plate 320 relative to the interbody fusion device 10. As shown in FIGS. 21A-21F, recesses, notches, or the like 346 may be provided in the lateral side of the single fixation plate 320 to allow for angulation of the single fixation plate 320 relative to the interbody fusion device 10. FIGS. 23C-23D are isometric views showing recesses or notches 346 in the single fixation plate 320 that allow for angulation of the single fixation plate 320 without interfering with the drive shaft 24 in the interbody fusion device 10.

[0074]

[0107] 24A-24D show that a single fixation plate 320 may be attached to the interbody fusion device 10 in various configurations, including a collapsed configuration, a fully expanded configuration, and a lordosis-adjusted or large lordosis-adjusted configuration, respectively. As an example of when the interbody fusion device 10 is placed between adjacent vertebral bodies via a lateral surgical procedure, FIG. 24A shows a single fixation plate 320 attached to the interbody fusion device 10 in a collapsed configuration having an anterior height of 8.4 mm, a posterior height of 8.4 mm, and a lordosis of 0 degrees. FIG. 24B shows an example in which a single fixation plate 320 is attached to the interbody fusion device 10 in a fully expanded configuration having a posterior height of 16.1 mm, and a lordosis of 0 degrees. Figure 24C illustrates an embodiment in which a single fixation plate 320 is attached to the interbody fusion device 10 in a large lordosis-adjusted configuration having an anterior height of 17.1 mm, a posterior height of 7.2 mm, and a lordosis of 30 degrees. Figure 24D illustrates an embodiment of the interbody fusion device 10 in a large lordosis-adjusted configuration having an anterior height of 17.1 mm, a posterior height of 7.2 mm, and a lordosis of 30 degrees. Comparing Figure 24D with Figure 24C, the single fixation plate 320 of Figure 24D is rotated an 11 degree angle relative to an imaginary plane that contains the first and second drive shafts. The angulation of the single fixation plate 320 allows the position of the apertures 326, 328 in the single fixation plate 320 to be adjusted according to, for example, the expansion configuration and / or lordosis adjustment configuration of the interbody fusion device 10, thereby providing an optimal path for the fixation devices to the vertebral bodies.

[0075]

[0108] The biaxial adjustable spinal system 300 may be used to treat various spinal disorders, including, but not limited to, degenerative disc disease (DDD), spondylolisthesis, and posterior spondylolisthesis (Grade 1). In addition, the fixation assembly 310 may be used to provide a complementary fixation device in the treatment of degenerative disc disease (DDD), spondylolisthesis, trauma (fractures and dislocations), curve deformities (scoliosis, kyphosis, and / or lordosis), tumors, nonunions, and previously failed fixations, trauma, tumors, deformities, nonunions, and previously failed fixations, etc. The uses, benefits, and advantages of the single fixation plate 300 are similar to those provided by the spinal system 200 described above in connection with FIGS. 12A-19B. Thus, detailed description is omitted herein for clarity. One uniqueness is that the single fixation plate 320 is variable within the spinal system 300. The absence of male geometry to mate with female geometry in the drive shaft allows the single fixation plate 320 to rotate relative to the interbody fusion device 10 in situ, thereby allowing for adjustment of the location of the apertures in the single fixation plate 320. Figures 25A-25B show an embodiment in which the interbody fusion device 10 is secured within the vertebral bodies 72 and 74 by a single fixation plate 320.

[0076]

[0109] Biaxial adjustable interbody fusion device with integrated fusion apparatus - Patent Application 20070123333

[0110] 26A-31B, an embodiment of a biaxial adjustable interbody fusion device according to the present disclosure will be described using an integrated fusion apparatus or device 400. This integrated design allows for a fixation plate to be implanted along with the interbody fusion device, and allows the angle of the fixation plate to be adjusted by expansion and / or adjustment of the interbody fusion device in situ, thereby providing stabilization of the interbody fusion device within the vertebral body and preventing its drift.

[0077]

[0111] 26A-26D, the apparatus 400 generally includes an interbody fusion device 10 and a fixation assembly 410. The interbody fusion device 10 may be the same as or similar to the exemplary biaxial adjustable interbody fusion device 10 described above in connection with FIGS. 1A-1C. Alternatively, the fusion device 10 may be any other biaxial adjustable interbody fusion device commercially available from a variety of manufacturers that may be further adapted or modified for use with the fixation assembly 410.

[0078]

[0112] Fixation assembly 410 includes a first or lower fixation plate 420 and a second or upper fixation plate 440. Fixation assembly 410 further includes a first fastener 424 and a second fastener 442. In accordance with certain embodiments of the present disclosure, lower fixation plate 420 is coupled to lower shell member 32 and configured to be positioned with interbody fusion device 10. Similarly, upper fixation plate 440 is coupled to upper shell member 34 and configured to be positioned with interbody fusion device 10. In certain embodiments, lower fixation plate 420 may be integrally formed with lower shell member 32. For example, lower fixation plate 420 and lower shell member 32 may be formed as a single part, or lower fixation plate 420 may be made as a separate piece and welded to or integral with lower shell member 32. Alternatively, the lower fixation plate 420 may be formed as a separate piece and coupled to the lower shell member 32 by an interference fit, a threaded connection, or any other suitable means. Similarly, the upper fixation plate 440 may be formed integrally with the upper shell member 34, for example, by being made as a single piece, or by being made as a separate piece and welded together. Alternatively, the upper fixation plate 440 may be formed as a separate piece and coupled to the upper shell member 34 by an interference fit, a threaded connection, or any other suitable means. This integrated design allows the lower shell member 420 and the upper fixation plate 440 to be implanted with the interbody fusion device 10. Coupling the lower fixation plate 420 to the lower shell member 32 and the upper fixation plate 440 to the upper shell member 34 allows the angles of the lower fixation plate 420 and the upper fixation plate 440 to be adjusted with expansion and / or adjustment of the interbody fusion device 10 in situ.

[0079]

[0113] The inferior fixation plate 420 includes an aperture 424 configured to insert a first fastener 422 therethrough for anchoring to a first vertebral body. The superior fixation plate 440 includes an aperture 444 configured to insert a second fastener 442 therethrough for anchoring to a second vertebral body. According to certain embodiments of the present disclosure, either or both of the inferior fixation plate 420 and the superior fixation plate 440 may be sized and / or shaped to minimize or reduce the profile of the fixation plate. Furthermore, the reduced profile of the inferior fixation plate 420 and / or the superior fixation plate 440 may allow for improved visualization of the device 400 within the patient, particularly when viewed from the side when implanted via a lateral approach. Furthermore, the reduced profile of the inferior fixation plate 420 and / or the superior fixation plate 440 may facilitate easier insertion and placement of the device 400 within the patient's anatomy. For example, either or both of the lower fixation plate 420 and the upper fixation plate 440 may be in the form of a screw loop or bracket where the fastener apertures 424 and / or 444 are formed or located adjacent to the periphery of the lower fixation plate 420 and / or upper fixation plate 440 such that the overall profile of the lower fixation plate 420 and upper fixation plate 440 may be minimized.

[0080]

[0114] According to certain embodiments of the present disclosure, apertures 424 in lower fixation plate 420 and apertures 442 in upper fixation plate 440 may be configured to allow the path of first fastener 422 and second fastener 442 to be adjustable in a caudal or cranial direction, as shown in Figures 26C-26D. For example, apertures 424 in lower fixation plate 420 and apertures 444 in upper fixation plate 440 may be cut such that the centerlines of apertures 424 and 444 form an angle of 0 degrees to 15 degrees with respect to a reference plane, such as the lower or upper shell member, as described above in connection with Figures 16A-16B. Alternatively or additionally, first fastener 422 and second fastener 442 may be sized and shaped to allow the path of the fastener to be adjustable. For example, first fastener 422 and second fastener 442 can have a spherical or tapered head portion as shown in FIGURE 28, allowing the fastener trajectory to be adjustable. In general, the trajectory of first fastener 422 and second fastener 442 can be angled from 0 degrees to 15 degrees in the caudal or cephalad direction relative to lower shell member 32 or upper shell member 34, respectively, allowing the fastener trajectory to be optimized to maximize or increase the effect of the fastener against the vertebral bodies.

[0081]

[0115] 26A-26D, the lower fixation plate 420 can have a locking mechanism 426 to prevent the fastener 422 from backing out. Similarly, the upper fixation plate 440 can have a locking mechanism 446 to prevent the fastener 442 from backing out. The locking mechanism 426 in the lower fixation plate 420 can be the same as or similar to the locking mechanism 446 in the upper fixation plate 440. For example, the locking mechanism 446 in the upper fixation plate 440 can have a locking bar 446a received in a recess 446b adjacent the aperture 444 in the upper fixation plate 440 and an adapter 446c welded or attached to the end of the locking bar 446a to retain the locking bar in the recess and allow the locking bar to pivot. 27A-27B, the head of locking bar 446a can have a rounded side portion 446a-1, a flat side portion 446a-2, and an end 446a-3 having structure configured to receive a driver to actuate locking mechanism 446. When locking bar 446a is pivoted to set locking mechanism 446 to an unlocked or open state, head flat side portion 446a-2 faces aperture 444 in fixation plate 440 as shown in FIG. 27A, opening aperture 444 and thereby allowing fixation device 442 to be inserted therethrough. Once the fastener 442 is driven all the way into the vertebral body so that the fastener head is received in the countersink of the aperture as shown in FIGURE 27B, the locking bar 446a can be pivoted to set the locking mechanism 446 to a locked state, where the rounded side portion 446a-1 of the head extends over at least a portion of the aperture 444 or over the fastener 442, thereby preventing the fastener 442 from backing out. The locking mechanism 446 of the present disclosure allows for quick "one-step" locking, where only one pivot of the locking bar 446a with a driving tool is required to lock or unlock the fastener.Additionally, the use of a "one-step" locking mechanism allows for the profile of the fixation plate to be simplified or reduced, which is advantageous in inserting and positioning the device in the patient's anatomy.

[0082]

[0116] 29A-29B, the integrated fixation plates 420, 440 of the present disclosure can stabilize and prevent movement of the interbody fusion device 10 in any expanded or adjusted configuration within the adjacent vertebrae. FIG. 29A illustrates an exemplary embodiment of the interbody fusion device 10 in a fully expanded configuration with an anterior height of 16.1 mm, a posterior height of 16.1 mm, and a lordosis of 0 degrees. FIG. 29B illustrates an exemplary embodiment of the interbody fusion device 10 in a large lordosis adjusted configuration with an anterior height of 17.1 mm, a posterior height of 7.2 mm, and a lordosis of 30 degrees. Although kyphosis (negative lordosis) adjustment may not be desired for the lumbosacral segment of the spine, the interbody fusion device 10 may have its lordosis adjusted. During expansion and / or lordosis adjustment of interbody fusion device 10, lower fixation plate 420 and upper fixation plate 440 move with lower shell member 32 and upper shell member 34, thereby allowing automatic adjustment of the position and / or angle of the apertures in lower fixation plate 420 and upper fixation plate 440. In any of the device configurations shown in Figures 29A-29B, the fastener path can be further varied, for example, in a caudal or cephalad direction, at an angle of 0 degrees to 15 degrees, thereby optimizing the fastener path to maximize or increase the effect of the fastener against the vertebral bodies. Figure 26B shows an embodiment of interbody fusion device 10 in a contracted configuration with an anterior height of 8.4 mm, a posterior height of 8.4 mm, and a lordosis of 0 degrees.

[0083]

[0117] A biaxial adjustable interbody fusion device with integrated fusion apparatus 400 may be used to treat a variety of spinal disorders, including, but not limited to, degenerative disc disease (DDD), spondylolisthesis, and posterior spondylolisthesis (Grade 1). With reference to FIG. 30, in use, an interbody fusion device with integrated fusion apparatus 400 in a collapsed configuration may be inserted into a patient's anatomy and positioned between adjacent vertebrae 72, 74 using an appropriate surgical instrument 70. Suitable surgical procedures for introducing the interbody fusion device into a patient's anatomy include a lateral lumbar interbody fusion (LLIF) procedure, an anterior lumbar interbody fusion (ALIF) procedure, a posterior lumbar interbody fusion (PLIF) procedure, and any other suitable surgical procedure performed within the lumbar spine or other regions of the spinal column. Various suitable surgical instruments are described in U.S. patent application Ser. No. 15 / 661,435, filed July 17, 2017, entitled "Surgical Operating Instrument for Expandable and Adjustable Lordosis Interbody Fusion Systems," and U.S. patent application Ser. No. 16 / 035,637, filed July 15, 2018, entitled "Surgical Operating Instrument for Expandable and Adjustable Lordosis Interbody Fusion Systems," all of which are incorporated herein by reference in their entirety. The interbody fusion device 10 may be expanded and / or its lordosis adjusted using the surgical instrument 70 to form the appropriate configuration between adjacent vertebrae 72, 74.

[0084]

[0118] Fasteners, such as bone screws 422, 442, may then be inserted through apertures in the lower and upper fixation plates 420, 440 and driven into the first and second vertebral bodies 72, 74, respectively. Once the fasteners 422, 442 are driven all the way so that their heads are received within the apertures in the fixation plates, the "one-step" locking mechanisms in the lower and upper fixation plates 420, 440 may be actuated using the surgical instrument 70, thereby locking the fasteners 422, 442 to prevent backout. The interbody fusion device 10 may then be stabilized and prevented from free movement within the vertebral bodies 72, 74, as shown in FIGS.

[0085]

[0119] 26A-31B, an embodiment of a biaxial adjustable interbody fusion device using an integrated fusion apparatus 400 is described. Beneficially, an interbody fusion device using an integrated fusion apparatus 400 can stabilize and prevent movement of the interbody fusion device in any configuration from a low expansion configuration to a fully expanded configuration and / or a large lordosis adjustment configuration, thereby safely facilitating fusion between two adjacent vertebral bodies. Interbody fusion devices of any size and configuration can be integrated with the fixation plates of the present disclosure and configured to be insertable via a single surgical approach and in a single patient position, thereby minimizing disruption to the patient's anatomy. The integration of the lower and upper fixation plates into the interbody fusion device allows the angulation of the fastener apertures, and therefore the fastener paths, to follow the angulation of the lower and upper shell members of the interbody fusion device, respectively, at any angle between 0 degrees and 15 degrees, thereby providing ideal fastener paths and placement. Other benefits and advantages are the same as or similar to those provided by the interbody fusion device using the modular fusion apparatus 100 described above in connection with the description of Figures 2A-11B, and therefore a detailed description thereof is omitted herein.

[0086]

[0120] According to an embodiment of the present disclosure, the first drive shaft 24 and the second drive shaft 26 of the interbody fusion device 10 in the apparatus 100 and 400 or in the systems 200 and 300 may be continuously operable to allow the distance between the lower shell member 32 and the upper shell member 34 in the first and / or second lateral areas of the housing to be continuously variable, thereby allowing the height of the expanded configuration of the interbody fusion device 10 to be continuously changed. For example, the height of the interbody fusion device 10 may be continuously changed by 0 millimeters to 10 millimeters. Additionally or alternatively, the first drive shaft 24 and the second drive shaft 26 of the interbody fusion device 10 in the apparatus 100 and 400 or in the systems 200 and 300 may be continuously operable to allow the angle between the lower shell member 32 and the upper shell member 34 to be continuously variable, thereby allowing the lordosis of the expanded configuration of the interbody fusion device 10 to be continuously changed. For example, the lordosis of the interbody fusion device 10 can vary continuously from 0 degrees to 30 degrees.

[0087]

[0121] All technical and scientific terms used herein have the meanings commonly understood by those skilled in the art unless otherwise specified. As used in this description and the appended claims, the singular forms "a", "an" and "the" include the plural forms unless the context dictates otherwise. The term "or" means a non-exclusive "or" unless the context dictates otherwise. The terms "first" or "second" are used to distinguish one element from another in describing various similar elements, and should not be construed as any particular order unless the context dictates otherwise.

[0088]

[0122] Those skilled in the art will recognize that various other modifications may also be made. All these and other variations and modifications are contemplated by the inventors as being within the scope of the present invention. [Explanation of symbols]

[0089] 10 Biaxial Adjustable Interbody Fusion Device 12 Expandable housing 13 First Lateral Area 14a Screw member 14b Screw member 15 Second Lateral Area 16a Screw member 16b Screw member 24 First Drive Shaft 25 Male thread 26 Second Drive Shaft 27 Female thread 32 Lower shell member 34 Upper shell member 42 Riser member 44 Riser member 46 1st Step Tracking Run 48 Second Step Tracking Run 50 central part 52 Tension spring 54 Extension spring 60 Thrust bearing 62 Slanted Geometry 70 Surgical instruments 72 vertebrae 74 vertebrae 100 devices 110 Fixed assembly 120 Fixing plate 122 Spinal anchor element 124 Aperture 126 Male geometry 127 Circular Groove 128 Channel Geometry 129a first end 129b second end 130 Mounting lock mechanism 130a lock housing 130b bar 130c compression spring 130d Latch 132 Fixture locking mechanism 132a Locking components 132b Recess 132c compression spring 132d Retainer 140 Fixing plate 142 Spinal anchor element 144 Aperture 146 Protruding part 150 Mounting lock mechanism 150a lock housing 150b bar 150c compression spring 150d Latch 152 Fixture locking mechanism 200 Spine System 210 Fixed assembly 220 Single Fixation Plate 222 Second Fixture 224 Second Fixture 226 First Aperture 227 Center line 228 Second Aperture 229 Center line 230 First Male Geometry 232 Secondary Male Geometry 234 Protruding part 240 Mounting lock mechanism 240a lock housing 240b bar 240c compression spring 240d Latch 242 Fixture locking mechanism 242a Locking Components 242b Recess 242c compression spring 242d Retainer 244 Fixture locking mechanism 300 Spine System 310 Fixed assembly 320 Single Fixation Plate 322 First Fixture 324 Second Fixture 326 First Aperture 328 Second Aperture 334 Protruding part 340 Mounting lock mechanism 340d Latch 342 Fixture locking mechanism 344 Fixture locking mechanism 400 equipment 410 Fixed assembly 420 Lower fixation assembly 414 First Drive Shaft 420 Fixing Plate 422 First Fixture 426 Fixture locking mechanism 440 Upper Fixation Plate 442 First Fixture 442 Second Fixture 444 Aperture 446 Fixture locking mechanism 446a Locking rod 446a-1 Rounded side portion 446a-2 Flat side 446a-3 End 446b Recess 446c Adapter

Claims

1. 1. An apparatus comprising an interbody fusion device and a fixation assembly, comprising: the interbody fusion device comprises a housing, a first wedge member, a second wedge member, a first drive shaft, and a second drive shaft; the housing having a first shell member and a second shell member, the first shell member and the second shell member engaged with the first wedge member along a first lateral area of ​​the housing and engaged with the second wedge member along a second lateral area of ​​the housing; a first wedge member provided with a through opening configured to allow passage of the first drive shaft therethrough, and a second wedge member provided with a through opening configured to allow passage of the second drive shaft therethrough; the first drive shaft is operable to drive the first wedge member along the first lateral area of ​​the housing and the second drive shaft is operable to drive the second wedge member along the second lateral area of ​​the housing, causing the first and second shell members to move relative to one another, thereby providing an expanded configuration of the interbody fusion device; the fixation assembly comprising a first fixation plate having a first aperture for insertion of a first fastener; 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 and secured to a first vertebral body in situ to stabilize the interbody fusion device and / or prevent movement of the interbody fusion device. Device.

2. 2. The apparatus of claim 1, 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 modularly 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 secured to a second vertebral body to stabilize the interbody fusion device and / or prevent movement of the interbody fusion device.

3. 3. The apparatus of claim 2, wherein the first fixation plate comprises a male geometry and the first drive shaft of the interbody fusion device comprises an end portion having a female geometry, and the male geometry of the first fixation plate and the female geometry of the first drive shaft of the interbody fusion device are configured with complementary mating features such that when the first fixation plate is attached to the interbody fusion device, the male geometry of the first fixation plate engages the female geometry of the first drive shaft of the interbody fusion device, thereby limiting undesired rotation of the first drive shaft.

4. 4. The apparatus of claim 3, wherein the first fixation plate is equipped with a channel geometry configured to receive an end portion of the second drive shaft of the interbody fusion device, the channel geometry extending from a first end to a second end thereby allowing the second drive shaft to be received at a position between the first end and the second end while pivoting the first fixation plate about the first drive shaft of the interbody fusion device such that a position of the first aperture in the first fixation plate can be adjusted relative to the first vertebral body.

5. The apparatus of claim 4 , wherein the channel geometry is configured to allow the first fixation plate to pivot up to about 15 degrees about the first drive shaft of the interbody fusion device.

6. The apparatus of claim 4 , wherein the first fixation plate comprises an attachment locking mechanism engageable to lock the interbody fusion device.

7. 7. The apparatus of claim 6, wherein the mounting locking mechanism of the first fixation plate comprises a lock housing, a rod having a first end portion and a second end portion, a compression spring loaded onto the rod and retained within the lock housing, and a latch coupled to the second end portion of the rod, wherein the latch interferes with the first drive shaft of the interbody fusion device when the mounting locking mechanism of the first fixation plate is actuated in a locked state.

8. 3. The apparatus of claim 2, wherein the second fixation plate comprises a protruding portion configured to be insertable into the interbody fusion device, the protruding portion having a geometry configured to be received within a structure in the second shell member of the interbody fusion device, thereby limiting undesired movement of the interbody fusion device.

9. The apparatus of claim 8 , wherein the second fixation plate comprises an attachment locking mechanism engageable to lock the interbody fusion device.

10. 10. The apparatus of claim 9, wherein the mounting locking mechanism of the second fixation plate comprises a lock housing, a rod having a first end portion and a second end portion, a compression spring loaded onto the rod and retained within the lock housing, and a latch coupled to the second end portion of the rod, wherein the latch engages a structure within the second shell member of the interbody fusion device when the mounting locking mechanism of the second fixation plate is actuated in a locked state.

11. 3. The apparatus of claim 2, wherein the first fixation plate comprises a fastener locking mechanism configured to prevent the first fastener from backing out of the first aperture in the first fixation plate, and the second fixation plate comprises a fastener locking mechanism configured to prevent the second fastener from backing out of the aperture in the second fixation plate.

12. 12. The apparatus of claim 11, wherein at least one of the fastener locking mechanism of the first fixation plate and the fastener locking mechanism of the second fixation plate comprises a locking component and a compression spring loaded onto the locking component, the compression spring having a free state and a compressed state that allows the locking component to extend over or retract from the first aperture in the first fixation plate or the second aperture of the second fixation plate.

13. 3. The apparatus of claim 2, wherein the first fixation plate comprises an edge portion having a concave profile and the second fixation plate comprises an edge portion having a convex profile, thereby allowing the first and second fixation plates to at least partially interdigitate when attached to the interbody fusion device in a contracted configuration.

14. 3. The apparatus of claim 2, wherein the first drive shaft and the second drive shaft are independently operable to drive the first wedge member and the second wedge member to different positions, whereby a degree of expansion of the interbody fusion device along the first lateral area of ​​the housing is independently adjustable relative to a degree of expansion of the interbody fusion device along the second lateral area of ​​the housing.

15. the first wedge member comprises a first pair of threaded members and the second wedge member comprises a second pair of threaded members; the first shell member comprises a plurality of individual riser members, the second shell member comprises a plurality of individual riser members, the plurality of individual riser members of the first shell member and the plurality of individual riser members of the second shell member defining a first tracking run along the first lateral area of ​​the housing and a second tracking run along the second lateral area of ​​the housing; 15. The apparatus of claim 14, wherein the first drive shaft is operable to rotate the first pair of threaded members, thereby enabling the first pair of threaded members to advance along the first drive shaft and move on the first tracking run, and the second drive shaft is operable to rotate the second pair of threaded members, thereby enabling the second pair of threaded members to advance along the second drive shaft and move on the second tracking run.

16. 16. The apparatus of claim 15, wherein the first drive shaft and the second drive shaft each include an end portion equipped with male and female threads, the male threads configured to be connected to a surgical instrument and the female threads configured to be engaged by a driver in the surgical instrument to apply torque.

17. 17. The apparatus of claim 16, wherein each of the first and second fixation plates comprises a mounting locking mechanism engageable to lock the interbody fusion device, the mounting locking mechanism comprising a lock housing, a rod having a first end portion and a second end portion, a compression spring loaded on the rod and retained within the lock housing, and a latch coupled to the second end portion of the rod, the first end portion of the rod equipped with internal threads substantially the same as the internal threads of the first and second drive shafts, and the lock housing adjacent the first end portion of the rod equipped with external threads substantially the same as the external threads of the first and second drive shafts, thereby enabling the surgical instrument to be connected to the first and second drive shafts of the interbody fusion device to drive the first and second drive shafts, thereby connected to the first and second fixation plates to actuate the mounting locking mechanisms of the first and second fixation plates, respectively.

18. 18. The apparatus of claim 17, wherein the first fixation plate further comprises a first fastener locking mechanism configured to prevent the first fastener from backing out of the first aperture in the first fixation plate, and the second fixation plate further comprises a second fastener locking mechanism configured to prevent the second fastener from backing out of the second aperture in the second fixation plate.

19. 20. The apparatus of claim 18, wherein at least one of the fastener locking mechanism of the first fixation plate and the fastener locking mechanism of the second fixation plate comprises a locking component and a compression spring loaded onto the locking component, the compression spring having a free state and a compressed state that allows the locking component to extend or retract over the first aperture in the first fixation plate or the second aperture of the second fixation plate.

20. 16. The apparatus of claim 15, wherein the first drive shaft and the second drive shaft are continuously operable to continuously vary the distance between the first and second shell members in the first and / or second lateral areas of the housing, thereby allowing the height of the expanded configuration of the interbody fusion device to be continuously changed.

21. 16. The apparatus of claim 15, wherein the first drive shaft and the second drive shaft are continuously operable to continuously change the angle between the first and second shell members, thereby allowing a continuously variable lordosis or kyphosis of the expanded configuration of the interbody fusion device.

22. The first fixing plate comprises a single fixing plate, a first fixing device, and a second fixing device; The single fixation plate is configured to be attachable to the interbody fusion device in the expanded configuration and includes a first aperture therethrough for inserting the first fastener to a first vertebral body and a second aperture therethrough for inserting the second fastener 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 second vertebral bodies, thereby stabilizing the interbody fusion device and / or preventing movement of the interbody fusion device. The spinal system of claim 1 .

23. 23. The system of claim 22, wherein the single fixation plate is constructed from a material having a strength capable of providing complementary fixation of the first and second vertebral bodies.

24. the single fixation plate comprises a first male geometry and a second male geometry, the first drive shaft of the interbody fusion device comprises an end portion having a first female geometry, the second drive shaft of the interbody fusion device comprises an end portion having a second female geometry, the first male geometry of the single fixation plate and the first female geometry of the first drive shaft of the interbody fusion device are configured with complementary mating features, and the second male geometry of the single fixation plate and the 23. The system of claim 22, wherein the second female geometry of the second drive shaft of an interbody fusion device is configured with complementary mating features such that when the single fixation plate is attached to the interbody fusion device, the first and second male geometries of the single fixation plate engage with the first and second female geometries in the end portions of the first and second drive shafts in the interbody fusion device, respectively, thereby limiting undesired rotation of the first and second drive shafts.

25. 23. The system of claim 22, wherein the single fixation plate comprises a protruding portion configured to be insertable into the interbody fusion device, the protruding portion having a geometry configured to mate with a component within the interbody fusion device, thereby limiting undesired movement of the interbody fusion device, and the single fixation plate further comprises an attachment locking mechanism engageable to lock the interbody fusion device.

26. 26. The system of claim 25, wherein the mounting locking mechanism comprises a lock housing within the overhanging portion of the single fixation plate, a rod having a first end portion and a second end portion, a compression spring loaded onto the rod and retained within the lock housing, and a latch coupled to the second end portion of the rod, the latch being rotationally engagable to engage a component within the interbody fusion device.

27. 23. The system of claim 22, wherein the single fixation plate further comprises a first fixator locking mechanism configured to prevent backout of the first fixator from the first aperture and a second fixator locking mechanism configured to prevent backout of the second fixator from the second aperture.

28. 28. The system of claim 27, wherein at least one of the first fastener locking mechanism and the second fastener locking mechanism comprises a locking component and a compression spring loaded onto the locking component, the compression spring having a free state that allows the locking component to extend over the first aperture or the second aperture and a compressed state that allows the locking component to be forced away from the first aperture or the second aperture.

29. 23. The system of claim 22, wherein the first drive shaft and the second drive shaft are independently operable to drive the first wedge member and the second wedge member separately to different positions, whereby a degree of expansion of the interbody fusion device along the first lateral area of ​​the housing is independently adjustable relative to a degree of expansion of the interbody fusion device along the second lateral area of ​​the housing.

30. The first fixation plate comprises a single fixation plate, a first fixation device, and a second fixation device, the single fixation plate being equipped with a first aperture through which the first fixation device is inserted to a first vertebral body and a second aperture through which the second fixation device is inserted to a second vertebral body; The single fixation plate is constructed such that it is insertable in situ into the interbody fusion device and rotatable relative to the interbody fusion device, thereby allowing the positioning of the first aperture and the second aperture within the single fixation plate to be adjusted in situ, allowing the single fixation plate to provide complementary fusion of the first and second vertebral bodies. The spinal system of claim 1 .

31. 31. The system of claim 30, wherein the single fixation plate is rotatable clockwise or counterclockwise from 0 degrees to 11 degrees relative to an imaginary plane that contains the first and second drive shafts of the interbody fusion device, thereby allowing the positioning of the first and second apertures within the single fixation plate to be adjusted in situ clockwise and / or counterclockwise from 0 degrees to 11 degrees.

32. 32. The system of claim 31 , wherein the single fixation plate comprises a protruding portion configured to be inserted into the expanded configuration of the interbody fusion device, the single fixation plate being optionally attachable to the interbody fusion device via the protruding portion of the single fixation plate.

33. 33. The system of claim 32, wherein the single fixation plate further comprises an attachment locking mechanism engageable to lock the interbody fusion device to the single fixation plate.

34. 1. An apparatus comprising an interbody fusion device and a fixation assembly, comprising: the interbody fusion device comprises a housing, a first wedge member, a second wedge member, a first drive shaft, and a second drive shaft; the housing having a first shell member and a second shell member, the first shell member and the second shell member engaged with the first wedge member along a first lateral area of ​​the housing and engaged with the second wedge member along a second lateral area of ​​the housing; a first wedge member provided with a through opening configured to allow passage of the first drive shaft therethrough, and a second wedge member provided with a through opening configured to allow passage of the second drive shaft therethrough; the first drive shaft is operable to drive the first wedge member along the first lateral area of ​​the housing and the second drive shaft is operable to drive the second wedge member along the second lateral area of ​​the housing, causing the first and second shell members to move relative to one another, thereby providing an expanded configuration of the interbody fusion device; 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; 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, angled in situ by movement of the first shell member and / or the second shell member, and fixed to adjacent vertebral bodies to stabilize the interbody fusion device and / or prevent its drift; the first fixation plate comprising a first fastener locking mechanism configured to prevent backout of the first fastener from the first aperture in the first fixation plate; the first fastener locking mechanism comprises a locking bar having a head with a rounded side portion and a flat side portion, the locking bar being rotatable to allow the rounded side portion to extend over the first aperture to achieve a locked state of the first fastener locking mechanism, or to allow the flat side portion to be oriented towards the first aperture to achieve an unlocked state of the first fastener locking mechanism; Device.

35. 35. The apparatus of claim 34, 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.

36. 35. The apparatus of claim 34, wherein the first fixation plate is a separate piece and is coupled to the first shell member by an interference fit or a threaded connection, and / or the second fixation plate is a separate piece and is coupled to the second shell member by an interference fit or a threaded connection.

37. 35. The apparatus of claim 34, wherein the first aperture in the first fixation plate is configured to allow a path of the first fastener to be adjusted at an angle between 0 degrees and 15 degrees, and / or the second aperture in the second fixation plate is configured to allow a path of the second fastener to be adjusted at an angle between 0 degrees and 15 degrees.

38. 35. The apparatus of claim 34, wherein the second fixation plate comprises a second fastener locking mechanism configured to prevent backout of the second fastener from the aperture in the second fixation plate.

39. 35. The apparatus of claim 34, wherein the first drive shaft and the second drive shaft are independently operable to drive the first wedge member and the second wedge member to different positions, whereby a degree of expansion of the interbody fusion device along the first lateral area of ​​the housing is independently adjustable relative to a degree of expansion of the interbody fusion device along the second lateral area of ​​the housing.

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