Biaxially adjustable spinal system and intervertebral fusion device with fixation

Abstract

A dual-axis adjustable spinal system and intervertebral fusion device with fixation members are disclosed. Also disclosed is an apparatus or system employing a fixation assembly to stabilize and prevent migration of an intervertebral fusion device placed between adjacent vertebral bodies, and / or to provide supplemental fixation of adjacent vertebral bodies. The fixation assembly can include a modular fixation plate that is insertable and attachable in situ to the intervertebral fusion device. In certain embodiments, the fixation assembly can include a single fixation plate that is insertable and / or attachable in situ to the intervertebral fusion device. In certain embodiments, the fixation plate is integrally formed with the intervertebral fusion device.

Description

TECHNICAL FIELD

[0001] The present disclosure relates generally to devices, systems, and methods for treating spinal disorders. In particular, various embodiments of a dual-axial adjustable spinal system and dual-axial intervertebral fusion device having a modular and integrated fixation are described. BACKGROUND

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

[0003] In intervertebral fusion surgery, the nucleus pulposus and / or annulus fibrosus that make up the intervertebral disc at the point of injury are removed and an implant that is constructed in shape and size is placed in the intervertebral disc space to restore the distance between adjacent vertebrae to a proper state. Surgical methods to perform intervertebral fusion vary and can access the patient’s spine through the abdomen or back. One surgical method for achieving lumbar fusion in a less invasive manner involves accessing the spine through a small incision on the posterior side, where the surgeon removes a portion of the bone and joint at the posterior and lateral sides of the vertebrae. These segments of bone and joint are referred to as the lamina and facet joints, respectively. This surgery is referred to as a transforaminal lumbar interbody fusion or lateral lumbar interbody fusion. This technique allows the surgeon to insert the bone graft and spacer from a unilateral approach laterally into the intervertebral disc space without having to aggressively retracted the nerve roots, which can reduce damage to the nerve roots and scarring compared to more traditional posterior approaches.

[0004] Conventionally, once the intervertebral disc is removed from the body, the surgeon typically applies pressure to different trial implants between the vertebral bodies in the particular region to determine the size of the implant to maintain the proper distance between adjacent vertebrae. The proper angle between the vertebral bodies must also be maintained to accommodate the natural curvature of the spine, e.g., lordosis. Thus, both the intervertebral disc height and lordosis must be considered during the selection of the fusion device for implantation. Conventional implant devices are typically pre-configured with a top surface angle and a bottom surface angle to accommodate the natural curvature of the spine. It is unlikely or difficult to determine these values precisely prior to operation. Additionally, the patient is subjected to significant invasive activity in implementing a trial-and-error approach to sizing and fitting the intervertebral fusion device into the target region for geometric configuration. If an over-lordotic sagittal profile configuration (>20°) is set or supplemental fixation is required for a lumbosacral level, the surgeon can place a spinal member in the form of an anterior column fixator, such as an additional plate and screw assembly, to prevent possible migration or migration of the fusion device in the intervertebral disc space and / or to provide temporary stabilization of the anterior column of the spine during the spinal fusion procedure until arthrodesis is performed. This can require the surgeon to perform a second surgery after placement of the fusion device, which in turn will extend the overall procedure time, resulting in a patient's more likely blood loss and anesthesia complications. SUMMARY

[0005] An embodiment of an apparatus includes an intervertebral fusion device and a fixation assembly. The fixation assembly can include one or more modular fixation plates that are insertable and attachable in situ to the intervertebral fusion device and one or more fasteners to stabilize and prevent migration of the intervertebral fusion device between adjacent vertebral bodies.

[0006] An embodiment of a system includes an intervertebral fusion device and a fixation assembly. The fixation assembly can include a single fixation plate that is insertable and attachable in situ to the intervertebral fusion device and two or more fasteners to stabilize and prevent migration of the intervertebral fusion device between adjacent vertebral bodies. Optionally, the single fixation plate provides supplemental fixation of adjacent vertebrae.

[0007] An embodiment of a system includes an intervertebral fusion device and a fixation assembly. The fixation assembly can include a single fixation plate that is insertable and attachable in situ to the intervertebral fusion device and two or more fasteners to stabilize and prevent migration of the intervertebral fusion device between adjacent vertebral bodies. The single fixation plate can be rotated or angled in situ relative to the intervertebral fusion device and can provide supplemental fixation of adjacent vertebrae.

[0008] Embodiments of a device include an intervertebral fusion device and a fixation assembly for stabilizing the intervertebral fusion device and preventing migration of the intervertebral fusion device between adjacent vertebral bodies. The fixation assembly can include one or more fasteners and one or more fixation plates formed integrally with the intervertebral fusion device.

[0009] This Summary is provided to introduce selected embodiments in a simplified form and is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to determine the scope of the claimed subject matter. The selected embodiments are presented only to provide a brief summary of some of the forms the application might take and to present an overview. The detailed description will describe other aspects and embodiments of the disclosure in more detail. BRIEF DESCRIPTION OF DRAWINGS

[0010] These and various other features and advantages of the present disclosure will be better understood and appreciated, as the same becomes better clarified with regard to the following detailed description and the accompanying drawings, wherein:

[0011] FIGS. 1A-1C An example dual-axis adjustable intervertebral fusion device according to embodiments of the present disclosure is depicted. FIG. 1A is an isometric view, FIG. 1B is a side view, and FIG. 1C is a cross-sectional view.

[0012] FIGS. 2A-2B An example dual-axis adjustable intervertebral fusion device with modular fixation according to embodiments of the present disclosure is depicted. FIG. 2A is a partial exploded view, FIG. 2B is an assembled view.

[0013] FIGS. 3A-3D An example modular lower fixation plate according to embodiments of the present disclosure is depicted. FIG. 3A is an isometric front view, FIG. 3B is an exploded view, FIG. 3C is a rear view, and FIG. 3D is a side view.

[0014] FIGS. 4A-4D An example modular upper fixation plate according to embodiments of the present disclosure is depicted. FIG. 4A is an isometric front view, FIG. 4B is an exploded view, FIG. 4C is a rear view, and FIG. 4D is a side view.

[0015] FIGS. 5A-5D Unlocking the attachment of the modular lower fixation plate to the dual-axis adjustable intervertebral fusion device in an unlocked state is shown. FIG. 5A is an isometric view, FIG. 5Bis a partial enlarged view of the attachment in the unlocked state, FIG. 5C is a cross-sectional view, and FIG. 5D is a partial enlarged cross-sectional view of the attachment in the locked state.

[0016] FIGS. 6A-6D An attachment of a modular lower fixation plate to a bi-axially adjustable intervertebral fusion device in the locked state is shown. FIG. 6A is an isometric view, FIG. 6B is a partial enlarged view of the attachment in the locked state, FIG. 6C is a cross-sectional view, and FIG. 6D is a partial enlarged cross-sectional view of the attachment in the locked state.

[0017] FIGS. 7A-7D Channel geometry in a modular lower fixation plate according to embodiments of the present disclosure is depicted. FIG. 7A is an isometric view, and FIG. 7B is a cross-sectional view showing a drive shaft of a bi-axially adjustable intervertebral fusion device housed at a lower end of the channel geometry, FIG. 7C is an isometric view, and FIG. 7D is a cross-sectional view showing the drive shaft housed at an upper end of the channel geometry.

[0018] FIGS. 8A-8B An attachment of a modular upper fixation plate to a bi-axially adjustable intervertebral fusion device is shown. FIG. 8A The attachment in the unlocked state is depicted, and FIG. 8B The attachment in the locked state is depicted.

[0019] FIGS. 9A-9C The attachment of a modular lower fixation plate and a modular upper fixation plate to a bi-axially adjustable intervertebral fusion device in a collapsed configuration, an expanded configuration, and an anterior lordotic adjustment configuration is shown, respectively.

[0020] FIGS. 10A-10B The attachment of a modular fixation plate to a bi-axially adjustable intervertebral fusion device placed between adjacent vertebrae using an operating instrument is depicted. FIG. 10A The attachment of a modular upper fixation plate is shown, and FIG. 10B The attachment of a modular lower fixation plate is shown.

[0021] FIGS. 11A-11B A bi-axially adjustable intervertebral fusion device secured to adjacent vertebral bodies by a lower fixation plate and an upper fixation plate is depicted. FIG. 11A is an anterolateral view, and FIG. 11B is an anterior perspective view.

[0022] FIGS. 12A-12E An example bi-axially adjustable combined spinal system according to embodiments of the present disclosure is depicted.FIGS. 12A-12B is an exploded view, FIGS. 12C-12D is an assembled view, and FIG. 12E is a cross-sectional view.

[0023] FIGS. 13A-13F depicts an example single fixation plate according to embodiments of the present disclosure. FIG. 13A is a front view, FIG. 13B is an exploded view, FIG. 13C is a rear view, FIG. 13D is a cross-sectional side view, FIG. 13E is a side view, and FIG. 13F is a rear view.

[0024] FIGS. 14A-14B shows attachment of a single fixation plate and screw assembly to a bi-axially adjustable intervertebral fusion device. FIG. 14A shows attachment unlocked, and FIG. 14B shows attachment locked.

[0025] FIGS. 15A-15B is a perspective view of a fastener locking mechanism as part of a fixation plate according to embodiments of the present disclosure. FIG. 15A shows an open state of the fastener locking mechanism, FIG. 15B shows a locked state of the fastener locking mechanism.

[0026] FIGS. 16A-16B shows angular measurement features of a bore in a single fixation plate. FIG. 16A is a front view, and FIG. 16B is a cross-sectional side view.

[0027] FIGS. 17A-17C shows attachment of a single fixation plate to a bi-axially adjustable intervertebral fusion device in a collapsed configuration, an expanded configuration, and an anterior lordosis adjustment configuration, respectively.

[0028] FIG. 18 shows attachment of a single fixation plate to a bi-axially adjustable intervertebral fusion device placed between adjacent vertebral bodies using an operating instrument.

[0029] FIGS. 19A-19B shows a bi-axially adjustable intervertebral fusion device secured to adjacent vertebral bodies by a single fixation plate. FIG. 19A is a side view, and FIG. 19B is a front perspective view.

[0030] FIGS. 20A-20D depicts an example bi-axially adjustable variable spinal system according to embodiments of the present disclosure. FIGS. 20A-20B is a partial exploded view, and FIGS. 20C-20D is an assembled view.

[0031] FIGS. 21A-21FAn example single fixation plate according to embodiments of the present disclosure is depicted. FIG. 21A is a front view, FIG. 21B is an exploded view, FIG. 21C is a rear view, FIG. 21D is a cross-sectional side view, FIG. 21E is a side view, and FIG. 21F is a rear view.

[0032] FIGS. 22A-22B Attachment of a single fixation plate to a dual-axially adjustable intervertebral fusion device is shown. FIG. 22A Attachment is shown unlocked, and FIG. 22B Attachment is shown locked.

[0033] FIGS. 23A-23D An example dual-axially adjustable intervertebral fusion device according to embodiments of the present disclosure is shown. FIGS. 21A-21F The ability of the single fixation plate depicted in FIG. 23A is an isometric end view, FIG. 23B is a cross-sectional end view, FIG. 23C is an isometric side view, and FIG. 23D is another isometric side view.

[0034] FIGS. 24A-24D Attachment of a single fixation plate to a dual-axially adjustable intervertebral fusion device in a collapsed configuration, an expanded configuration, and an anterior lordosis adjustment configuration is shown, respectively.

[0035] FIGS. 25A-25B An example dual-axially adjustable intervertebral fusion device secured to adjacent vertebral bodies by a single fixation plate is shown. FIG. 25A is a side view, and FIG. 25B is a front perspective view.

[0036] FIGS. 26A-26D An example dual-axially adjustable intervertebral fusion device with integral fixation according to embodiments of the present disclosure is depicted. FIG. 26A is a partial exploded view, FIG. 26B is an assembled isometric view, FIG. 26C is an assembled front view, and FIG. 26D is an assembled end view.

[0037] FIGS. 27A-27B An example fastener locking mechanism according to embodiments of the present disclosure is depicted. FIG. 27A An unlocked state of the fastener locking mechanism is shown, and FIG. 27B A locked state of the fastener locking mechanism is shown.

[0038] FIG. 28is a cross-sectional view of an example dual-axial adjustable intervertebral fusion device with integral fixation of the present disclosure, emphasizing the countersunk head of the fastener received in the counterbore of the integral fixation plate.

[0039] FIGS. 29A-29B An angle measurement of the integral fixation plate in an example adjustable intervertebral fusion device in an expanded configuration and an anterior lordotic adjustment configuration is shown, respectively.

[0040] FIG. 30 An example dual-axial adjustable intervertebral fusion device with integral fixation is shown secured to adjacent vertebral bodies using an operating instrument.

[0041] FIGS. 31A-31B An example dual-axial adjustable intervertebral fusion device with integral fixation plate is shown secured to adjacent vertebral bodies. FIG. 31A is a front side view, and FIG. 31B is a front perspective view. DETAILED DESCRIPTION

[0042] Reference will now be made to FIGS. 1A-31B wherein like numerals refer to like sections thereof, various embodiments of spinal systems and intervertebral fusion devices with fixation will now be described. It should be noted that the drawings are intended to be more illustrative than specific, and are not intended to limit the scope of the present disclosure. Moreover, certain specific details of the disclosure are set forth in order to provide a thorough understanding of various embodiments of the present disclosure. Those skilled in the relevant art will recognize, however, that the application can be practiced without one or more of the specific details, or with other methods, components, materials, and so forth. In other instances, well-known structures, components, or steps have not been shown or described in order to avoid obscuring aspects of the disclosure. It should be noted that certain aspects or features described in connection with a particular embodiment can not necessarily be limited to that embodiment and can be practiced in any of the other embodiments.

[0043] Generally, various embodiments of devices or systems for treating spinal conditions include an intervertebral fusion device and a fixation assembly. The intervertebral fusion device can be positioned between adjacent vertebrae in a spinal region of a patient. The configuration of the intervertebral fusion device can be adjusted to provide, for example, an expanded configuration, an anterior convex configuration, a posterior convex configuration, or an over-convex or over-posterior convex configuration that is appropriate for treating the patient. The fixation assembly provides stability and prevents migration of the intervertebral fusion device in the expanded configuration and / or the anterior convex adjusted configuration, thereby facilitating safe bony fusion. Alternatively or additionally, the fixation assembly provides corrective support or supplemental fixation to hold the adjacent vertebrae in place, which can be required to treat certain spinal conditions. To facilitate description of the present disclosure, the phrase "intervertebral fusion device with fixation" can be used to refer to a device that includes an intervertebral fusion device and a fixation assembly for stabilizing the intervertebral fusion device and preventing migration of the intervertebral fusion device; and the phrase "spinal system" can be used to refer to a system that includes an intervertebral fusion device and a fixation assembly for stabilizing the intervertebral fusion device and preventing migration of the intervertebral fusion device, and / or providing supplemental fixation to hold the adjacent vertebrae in place.

[0044] Biaxially adjustable intervertebral fusion device

[0045] The intervertebral fusion devices included in the spinal systems and devices of the present disclosure can be any suitable fusion device. According to certain embodiments of the present disclosure, the intervertebral fusion device can be a biaxially adjustable fusion device. The biaxially adjustable intervertebral fusion device includes two drive mechanisms that can be separately, independently, or simultaneously operated in situ to adjust the configuration of the intervertebral fusion device in a height and / or shape that is appropriate for treating the patient. By way of example, the configuration of a biaxial intervertebral fusion device positioned between adjacent vertebrae can be adjusted by operating the two drive mechanisms along the anterior and / or posterior sides of the patient to achieve a desired sagittal balance or correct a sagittal imbalance in the patient. Alternatively, the configuration of a biaxially adjustable intervertebral fusion device positioned between adjacent vertebrae can be adjusted by operating the drive mechanisms along the lateral and / or contralateral sides of the patient to achieve a desired coronal balance or correct a coronal imbalance in the patient.

[0046] An example biaxially adjustable intervertebral fusion device can include a housing, a first wedge member, a second wedge member, a first drive shaft, and a second drive shaft. The housing can include a first housing member and a second housing member. The first housing member and the second housing member can be engaged with the first wedge member along a first lateral region of the housing and engaged with the second wedge member along a second lateral region of the housing. The first wedge member can be provided with a through opening configured to allow the first drive shaft to pass through. The second wedge member can be provided with a through opening to allow the second drive shaft to pass through. The first wedge member and the second wedge member can be tapered members. Example tapered members include, but are not limited to, rotatable tapered screws and slidable tapered plates.

[0047] The first drive shaft is operable to drive the first wedge member along the first lateral region of the housing, and the second drive shaft is operable to drive the second wedge member along the second lateral region of the housing, thereby moving the first and second shell members relative to each other, thereby expanding the interbody fusion device. The first and second drive shafts can be independently operable to drive the first and second wedge members to different positions, thereby expanding the interbody fusion device to a different extent along the first lateral region of the housing than the extent of expansion of the interbody fusion device along the second lateral region of the housing.

[0048] The first and second wedge members can 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 can be screw members having threads configured to rotate and move along the first and second lateral sides of the housing to expand or contract the interbody fusion device. By way of example, the interbody fusion device can include a first pair of screw members and a second pair of screw members. The first shell member can include a plurality of individual riser members, and the second shell member can 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 can define a first trackway along the first lateral region of the housing and a second trackway along the second lateral region of the housing. The first drive shaft is operable to rotate the first pair of screw members to allow the first pair of screw members to travel along the first drive shaft and move over the first trackway. The second drive shaft is operable to rotate the second pair of screw members to allow the second pair of screw members to travel along the second drive shaft and move over the second trackway.

[0049] Various embodiments of the interbody fusion device are described in U.S. Patent Nos. 9,889,019, 10,188,527, and U.S. Application Serial No. 16 / 569,62, filed September 12, 2019, entitled “Expandable and Adjustable Lordosis Interbody Fusion System.” The disclosures of U.S. Patent Nos. 9,889,019, 10,188,527, and U.S. Serial No. 16 / 569,62 are incorporated by reference herein in their entireties.

[0050] FIGS. 1A-1CAn example dual-axial adjustable intervertebral fusion device 10 is shown that can be used in a spinal system or apparatus according to embodiments of the present disclosure. As shown, the dual-axial adjustable intervertebral fusion device 10 includes 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 can each be provided with a through opening configured to allow the first drive shaft 24 to pass through and engage with the first pair of screw members 14a, 14b. The second pair of screw members 16a, 16b can each be provided with a through opening configured to allow the second drive shaft 26 to pass through and engage with the second pair of screw members 16a, 16b.

[0051] The housing 12 can include a first or lower housing member 32 and a second or upper housing member 34. The lower housing member 32 can include a plurality of individual standpipe members 42 FIG. 1B ). The upper housing member 34 can include a plurality of individual standpipe members 44 FIG. 1B ). The plurality of individual standpipe members 42 of the lower housing member 32 and the plurality of individual standpipe members 44 of the upper housing member 34 can define a first stepped trackway 46 along a first lateral region 13 of the housing 12 and a second stepped trackway 48 along a second lateral region 15 of the housing 12 FIG. 1C . The height of the plurality of individual standpipe members 42, 44 can vary along the first stepped trackway 46 and the second stepped trackway 48. For example, the height of the plurality of individual standpipe members 42, 44 of each of the first stepped trackway 46 and the second stepped trackway 48 can increase from a central portion 50 of the stepped trackway, extending distally from the central portion. The first pair of screw members 14a-14b and the second pair of screw members 16a-16b can each include a helical thread having a thickness configured to fit within a gap between adjacent individual standpipe members.

[0052] The first drive shaft 24 is operable to rotate the first pair of screw members 14a, 14b to move the first pair of screw members 14a, 14b along the first stepped orbital run 46 on the separate riser members 42, 44. The second drive shaft 26 is operable to rotate the second pair of screw members 16a, 16b to move the second pair of screw members 16a, 16b along the second stepped orbital run 48 on the separate riser members 42, 44. In response to rotation of the first and second pairs of screw members 14a-14b and 16a-16b, the lower and upper shell members 32, 34 can be moved relative to one another to effect expansion of the housing 12 or contraction of the housing 12 from expansion by reversing rotation of the first and / or second pairs of screw members. The first and second drive shafts 24, 26 are independently operable from one another. Thus, the degree of expansion or contraction of the first lateral region 13 of the housing 12 can be independently adjusted relative to the degree of expansion or contraction of the second lateral region 15 of the housing 12 as the first and second sets of screw members 14a-14b and 16a-16b are independently rotated to different positions on the first and second stepped orbital runs 46, 48.

[0053] The positions of the plurality of separate riser members 42 on the lower shell member 32 can be arranged to be offset relative to the positions of the plurality of separate riser members 44 on the upper shell member 34 such that the plurality of separate riser members 42 of the lower shell member 32 can intermesh with the plurality of separate riser members 44 of the upper shell member 34 when the housing 12 is in the contracted configuration.

[0054] The first and second pairs of screw members 14a-14b and 16a-16b can each have a tapered configuration and include helical threads. The first pair of screw members 14a-14b can be arranged or disposed such that the direction orientation of the helical threads of the first screw member 14a of the first pair is opposite the direction orientation of the second screw member 14b of the first pair such that the first and second screw members 14a, 14b of the first pair move in opposite directions relative to one another in the first stepped orbital run 46 upon rotation of the first drive shaft 24. Similarly, the second pair of screw members 16a-16b can be arranged or disposed such that the direction orientation of the helical threads of the first screw member 16a of the second pair is opposite the direction orientation of the second screw member 16b of the second pair such that the first and second screw members 16a, 16b of the second pair move in opposite directions relative to one another in the second stepped orbital run 48 upon rotation of the second drive shaft 26.

[0055] By way of example, the first pair of screw members 14a-b and the second pair of screw members 16a-b can be arranged such that upon rotation of the first drive shaft 24 in a first direction, e.g., clockwise, the first pair of screw members 14a-b are each moved distally along the first stepped track run 46 from the central portion 50, and upon rotation of the second drive shaft 26 in a second direction opposite the first direction, e.g., counterclockwise, the second pair of screw members 16a-b are each moved distally along the second stepped track run 48 from the central portion 50. Alternatively, the first pair of screw members 14a-b and the second pair of screw members 16a-b can be arranged such that upon rotation of the first drive shaft 414 in a first direction, the first pair of screw members 14a, 14b are each moved distally along the first stepped track run 46 from the central portion 50, and upon rotation of the second drive shaft 26 in a second direction that is the same as the first direction, the second pair of screw members 16a, 16b are each moved distally along the second stepped track run 48 from the central portion 50.

[0056] The first drive shaft 24 and the second drive shaft 26 can each include features at their end portions for connection with an operating instrument and for receiving and engaging a driver in an operating instrument. By way of example, the end portions of each of the first drive shaft 24 and the second drive shaft 26 can be provided with an external thread 25 for connection with an operating instrument and an internal thread 27 for receiving and engaging a driver in an operating instrument. FIG. 1A

[0057] The dual-axially adjustable intervertebral fusion device 10 can include one or more tension springs 52, 54 coupled with the lower shell member 32 and the upper shell member 34. The tension springs 52, 54 can assume the entire device is held together. There can be a severe coronal or sagittal imbalance in a patient that can exert an uneven force distribution on the intervertebral fusion device when implanted in the patient. An uneven force distribution on the internal mechanism can cause the fusion device to separate. The tension springs 52, 54 can also be used to hold opposing forces on the fusion device. Once pressure is applied to the upper and lower shell members of the device, the mechanism inside the fusion device can be subjected to expansion and / or lordotic adjustment. The mechanism can need equal and opposite forces to move effectively and properly. The tension springs 52, 54 can create an initial tension against the mechanism, allowing the mechanism to expand and / or lordotically adjust when, for example, the patient's vertebral bodies are not in contact with the device.

[0058] ​The intervertebral fusion device 10 can include one or more thrust bearings 60 configured to limit unwanted axial and / or lateral movement of the drive shafts 24, 26 while allowing the drive shafts 24, 26 to rotate about the longitudinal axis of the drive shafts 24, 26. The thrust bearings 60 can be designed with a ramped geometry 62 FIG. 1A that allows an instrument carrying bone graft material to be guided into the device housing 12. The ramped geometry can also allow for the insertion of a fixation plate into the intervertebral fusion device for stabilizing the intervertebral fusion device placed in adjacent vertebrae and preventing migration of the intervertebral fusion device, as will be described in greater detail below.

[0059] The lower and upper shell members 32, 34 of the housing 12 can include one or more openings or windows for receiving bone graft material or allowing bone to pass through as fusion occurs. Suitable bone graft material includes, but is not limited to, autograft bone graft material and / or allograft bone graft material including, for example, cancellous and / or corticocancellous bone grafts. The bone graft material can be packed into the intervertebral fusion device 10 prior to being placed between vertebral bodies and / or added to the intervertebral fusion device 10 after the intervertebral fusion device 10 is expanded and lordotically adjusted to the appropriate configuration between the vertebral bodies. The sides or edges of the lower and upper shell members 32, 34 can include chamfered or rounded portions to facilitate insertion of the intervertebral fusion device into the patient's anatomy. The surfaces of the lower and upper shell members 32, 34 can include a variety of features, such as serrations, teeth, recesses, indentations, etc. to help prevent migration of the device or provide better retention.

[0060] The intervertebral fusion device 10 or a portion of the intervertebral fusion device 10 can be constructed from a material including a metal such as titanium, tantalum, stainless steel, any other biocompatible metal or alloy. The intervertebral fusion device 10 or a portion of the intervertebral fusion device 10 can also be constructed from a polymeric material such as polyether ether ketone (PEEK), polyether ketone ketone (PEKK), polyether ketone (PEK), etc.

[0061] The intervertebral fusion device 10 can be any size suitable for a spinal fusion procedure. By way of example, the distance from the proximal end of the device to the distal end of the device along the drive shafts 24, 26 ("length") can be in the range of 30 millimeters (mm) to 60 millimeters (mm). The distance from the lateral side of the device to the opposite lateral side ("width") can be in the range of 10 mm to 30 mm. The device can be manufactured in multiple products with different lengths and widths in different increments, for example, 2 mm width increments and 5 mm length increments. The distance from the lower shell member surface to the upper shell member surface of the intervertebral fusion device in the fully collapsed configuration ("base height") can be in the range of 5 mm to 10 mm. The dual-axis drive mechanism according to embodiments of the present disclosure can provide continuous expansion in height adjustment, for example, in the range of 0 mm to 8 mm when operated simultaneously together, or for example, in the range of 0 mm to 9 mm when operated independently of each other. The dual-axis drive mechanism according to embodiments of the present disclosure can provide a continuous angle between the lower shell member surface and the upper shell member surface ("lordosis") in the range of 0 degrees to 30 degrees. It should be noted that the provision of the specific dimensions described above is for the purpose of thorough understanding of various aspects of the present disclosure and is not intended to limit the scope of the claims.

[0062] Dual-axially adjustable intervertebral fusion device with modular fixation

[0063] Reference FIGS. 2A-11B Embodiments of a dual-axially adjustable intervertebral fusion device or apparatus 100 with modular fixation according to the present disclosure will now be described. The use of one or more modular fixation plates allows for the attachment of the fixation assembly to the fixation assembly in situ after the intervertebral fusion device is adjusted to the desired configuration in adjacent vertebrae and provides stabilization of the intervertebral fusion device and prevents migration of the intervertebral fusion device.

[0064] As FIGS. 2A-2B shown in FIG. 1, the apparatus 100 generally includes an intervertebral fusion device 10 and a fixation assembly 110 including one or more modular fixation plates 120, 140 and spinal anchoring components 122 and 142. The intervertebral fusion device 10 can be the same or similar to the example dual-axially adjustable intervertebral fusion device 10 described above in connection with FIGS. 1A-1C The intervertebral fusion device 10 can be the same or similar to the example dual-axially adjustable intervertebral fusion device 10 described above in connection with

[0065] The fixation assembly 110 includes at least one first fixation plate or lower fixation plate 120 and at least one first spinal anchoring component or first spinal fastener 122. Additionally or alternatively, the fixation assembly 110 includes a second fixation plate or upper fixation plate 140 and a second spinal anchoring component or second spinal fastener 142. As used herein, the term "fixation plate" includes reference to a plate member, or a plate assembly including a plate member and other portions, or a mechanism assembled to a plate member. According to embodiments of the present disclosure, the lower fixation plate 120 is modular and configured to be attachable to the intervertebral fusion device 10. As used herein, the term "modular" refers to embodiments of a fixation plate that are configured as a unit and are attachable to the intervertebral fusion device before or after implantation of the intervertebral fusion device. A modular fixation plate in a fixation assembly can be replaced by another modular fixation plate of the same structure as the fixation plate being replaced. The lower fixation plate 120 can be provided with an aperture 124 configured for insertion of the first fastener 122 therethrough to a first vertebral body or lower vertebral body. Likewise, according to certain embodiments of the present disclosure, the upper fixation plate 140 is modular and configured to be attachable to the intervertebral fusion device 10. The upper fixation plate 140 can be provided with an aperture 144 configured for insertion of the second fastener 142 therethrough to a second vertebral body or upper vertebral body. Example fasteners or anchoring components suitable for the first fastener 122 and / or the second fastener 144 include, but are not limited to, a spinal expansion head screw, a spinal locking screw, a spinal self-locking screw, a spinal shaft screw, a spinal nail, a spinal barb, a spinal hook, or other threaded or unthreaded member that can be anchored to a vertebral body. In FIG. 2B The assembly view shown in FIG. 12 illustrates the modular lower fixation plate 120 and the modular upper fixation plate 140 attached to the intervertebral fusion device 10 by the first fastener 122 and the second fastener 142 inserted through the apertures in the lower fixation plate 120 and the upper fixation plate 140. It should be noted that, in use, the modular lower fixation plate 120 and the modular upper fixation plate 140 can be attached to the intervertebral fusion device 10 in situ or after the intervertebral fusion device 10 has been placed between adjacent vertebral bodies and adjusted to a desired configuration. If desired, the modular lower fixation plate 120 and the modular upper fixation plate 140 can also be attached to the intervertebral fusion device 10 prior to implantation of the intervertebral fusion device. The modular lower fixation plate 120 and the modular upper fixation plate 140 will be described in greater detail below. FIGS. 10A-10B It is shown that, after the intervertebral fusion device 10 has been placed between adjacent vertebrae, expanded and / or lordotically adjusted to an appropriate configuration, the modular upper fixation plate 140 and the modular lower fixation plate 120 are attached to the intervertebral fusion device 10 by the operator instrument 70.

[0066] Referring to FIGS. 3A-3D, the modular lower fixation plate 120 can be configured to attach to the intervertebral fusion device 10 for stabilizing the intervertebral fusion device 10 and preventing migration of the intervertebral fusion device 10 in the adjacent vertebrae. According to certain embodiments of the present disclosure, the modular lower fixation plate 120 can be provided with a geometric feature configured to attach to the intervertebral fusion device 10 to prevent unwanted rotation of a drive shaft, such as the posterior drive shaft of the intervertebral fusion device 10. For example, the lower fixation plate 140 can include a male geometric feature 126 FIG. 3C that is configured to be inserted into a female geometric feature 27 located in an end portion of the posterior drive shaft 24 of the intervertebral fusion device 10. By way of example, the male geometric feature 126 in the lower fixation plate 120 can have a male hexalobular feature that can be tightly fitted into a female hexalobular feature 27 located in an end portion of the posterior drive shaft 24 to prevent unwanted rotation of the drive shaft. An annular groove 127 around the male geometric feature 126 can be provided to accommodate the end portion of the posterior drive shaft 24. The FIGS. 5A-5D and FIGS. 6A-6D attachment of the lower fixation plate 120 to the intervertebral fusion device 10 is shown, where the male geometric feature 126 in the lower fixation plate 120 is tightly fitted into the female geometric feature 27 located in an end portion of the posterior drive shaft 24.

[0067] Referring to FIGS. 3A-3D , the lower fixation plate 120 can be provided with a geometric feature that allows the lower fixation plate 120 to pivot with respect to the intervertebral fusion device 10 before the male geometric feature 126 in the lower fixation plate 120 is fitted into the female geometric feature 27 located in an end portion of the posterior drive shaft 24 of the intervertebral fusion device 10. For example, the lower fixation plate 120 can include a channel geometric feature 128 configured to accommodate an end portion of the anterior drive shaft 26 of the intervertebral fusion device 10. The channel geometric feature 128 allows the lower fixation plate 120 to be "pivoted" about the posterior drive shaft 24 by accommodating the end portion of the anterior drive shaft 26 in the channel geometric feature 128 without interfering with the anterior drive shaft 26. The ability of the lower fixation plate 120 to pivot allows the position of the aperture 124 in the lower fixation plate 120 to be adjusted, for example, according to an expansion configuration and / or an anterior lordosis adjustment configuration of the intervertebral fusion device 10, thereby providing an optimal position of the aperture for a fastener with respect to the vertebral body. FIGS. 7A-7DThe channel geometry in the lower fixation plate 120 when attached to the intervertebral fusion device 10 is shown. The channel geometry 128 extends from a first end 129a to a second end 129b, allowing the lower fixation plate 120 to be "pivoted" about the posterior drive shaft 24 by housing the end portion of the anterior drive shaft 26 in the channel 128 at a location described below: for example, at the first end 129a when the intervertebral fusion device is in an expanded but not lordotic adjustment configuration FIGS. 7A-7B ), or at the second end 129b when the intervertebral fusion device 10 is in an over-lordotic adjustment configuration FIGS. 7C-7D ), or at any location between the first end 129a and the second end 129b when the intervertebral fusion device 10 is in a configuration between the non-lordotic adjustment configuration and the over-lordotic adjustment configuration.

[0068] Referring to FIGS. 3A-3D , the lower fixation plate 120 can include an attachment locking mechanism 130 that is capable of engaging to lock the intervertebral fusion device 10 to ensure attachment of the lower fixation plate 120 to the intervertebral fusion device 10. According to certain embodiments of the present disclosure, the attachment locking mechanism 130 can include a locking receptacle 130a, a rod 130b, a compression spring 130c loaded on the rod 130b and held in the locking receptacle 130a, and a latch 130d coupled to a distal end portion of the rod 130b. A proximal end portion of the rod 130b can have a feature for receiving a driving tool to actuate the attachment locking mechanism 130. For example, the proximal end portion of the rod 130b can be provided with a female hexalobular feature for receiving a hex key driver. In use, a user can press the rod 130b by the driver to displace the latch 130d coupled to the distal end portion of the rod 130b to allow the latch 130d to rotate and hook onto a component in the intervertebral fusion device 10. The compression spring 130c loaded on the rod 130b exerts a force on the latch 130d, and upon release of the driver, the latch 130d tightens the attachment of the lower fixation plate 120 to the intervertebral fusion device 10, or locks the intervertebral fusion device 10 to the lower fixation plate 120. The locking receptacle 130a can be provided with a feature, such as a thread, configured for connection with an operating instrument. FIGS. 5A-5D The latch 130d of the attachment locking mechanism 130 in an unlocked state is shown. FIGS. 6A-6C The latch 130d of the attachment locking mechanism 130 in a locked state is shown, where the latch 130d interferes with or holds in place an external thread in an end portion of the posterior drive shaft 24, preventing unwanted rotation of the posterior drive shaft 24.

[0069] Still referring to FIGS. 3A-3DThe lower fixation plate 120 can include a fastener locking mechanism 132 configured to prevent the first fastener 122 from backing out of the aperture 124 after being tightened. According to certain embodiments of the present disclosure, the fastener locking mechanism 132 can include a locking member 132a received in a recess 132b adjacent to the fastener aperture 124 in the lower fixation plate 120, a compression spring 132c loaded on a portion of the locking member 132a, and a retainer 132d connected to a portion of the locking member 132a. The retainer 132d holds the locking member 132a in the recess 132b via the compression spring loaded on the locking member 132a and is slidable by the locking lever 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 member 132a to partially extend beyond the aperture 124 in the lower fixation plate 120, and an unlocked state when the compression spring 132c is in a compressed state to force the locking member 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 member 132a is forced away from the aperture 124, thereby allowing the fastener 122 to be driven, e.g., screwed, into the vertebral body. Once the fastener 122 is driven all the way and the head of the fastener 122 is received in the counterbore of the aperture 124 and flush with or below the surface of the fixation plate 120, the spring-loaded locking member 132a at least partially springs back over the fastener head, thereby preventing the fastener 122 from backing out. The fastener locking mechanism 132 allows for "zero-step" locking, as the surgeon does not need any additional instruments or steps to engage the fastener locking mechanism 132 to cover the fastener head to prevent the fastener from backing out. FIGS. 15A-15B An example fastener locking mechanism 242 in the fixation plate 220 to be described below is shown more clearly. The fastener locking mechanism 132 in the lower fixation plate 120 can be the same as or similar to the fastener locking mechanism 242 in the fixation plate 220 shown in FIGS. 1 1A-1 1C. FIGS. 15A-15B Alternatively, the fastener locking mechanism 132 in the lower fixation plate 120 can be the same as or similar to the fastener locking mechanism 446 to be described in connection with FIGS. 16A-16C. FIGS. 27A-27B

[0070] Reference is now made to FIGS. 4A-4D ​The modular upper fixation plate 140 can be configured to attach to the intervertebral fusion device 10 for stabilizing and preventing migration of the intervertebral fusion device 10 placed in adjacent vertebrae. According to certain embodiments of the present disclosure, the modular upper fixation plate 140 can include a protruding portion 146 configured to be inserted into the intervertebral fusion device 10. The protruding portion 146 can have a geometry configured to fit tightly with internal components of the intervertebral fusion device 10 to limit unwanted movement of the intervertebral fusion device 10. By way of example, the protruding portion 146 can have a generally rectangular prismatic shape that can fit tightly in or between channels in an inner surface of the upper shell member 24. Accordingly, translational movement of the intervertebral fusion device 10 relative to the upper fixation plate 140 in lateral, posterior, and / or anterior directions can be limited or minimized. The protruding portion 146 can also take any other suitable shape or form. FIGS. 8A-8B The upper fixation plate 140 is shown inserted in the intervertebral fusion device 10.

[0071] Referring to FIGS. 4A-4D The upper fixation plate 140 can include an attachment locking mechanism 150 that is capable of engaging to secure or lock the intervertebral fusion device 10 to the attachment of the upper fixation plate 140. The attachment locking mechanism 150 of the upper fixation plate 140 is identical or similar to the attachment locking mechanism 130 of the lower fixation plate 120 in many respects. For completeness of description, the attachment locking mechanism 150 of the upper fixation plate 140 can include a locking receptacle 150a, a rod 150b, a compression spring 150c loaded on the rod 150b and held in the locking receptacle 150a, and a latch 150d coupled to a distal end portion of the rod 150b. FIG. 8A The attachment locking mechanism 150 is shown in an unlocked state with the upper fixation plate 140 inserted in the intervertebral fusion device 10. FIG. 8B The attachment locking mechanism 150 is shown in a locked state with the upper fixation plate 140 inserted in and locked to the intervertebral fusion device 10.

[0072] Still referring to FIGS. 4A-4D The upper fixation plate 140 can also include a fastener locking mechanism 152 configured to prohibit the second fastener 142 from exiting the aperture 144 in the upper fixation plate 140. The fastener locking mechanism 152 of the upper fixation plate 140 is identical or similar to the fastener locking mechanism 132 of the lower fixation plate 120 in many respects, and detailed description of the fastener locking mechanism 152 is omitted herein.

[0073] Returning to FIGS. 2A-2BThe modular lower fixation plate 120 and the modular upper fixation plate 140 can be shaped and / or sized or configured to allow the two fixation plates to at least partially intermesh when attached to the intervertebral fusion device. By way of 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 at least partial intermeshing, thereby allowing the lower fixation plate 120 and the upper fixation plate 140 to be attached to the intervertebral fusion device 10 when the intervertebral fusion device 10 is in a less contracted configuration or an expanded configuration. The rounded or scalloped profile of the concave edge portion 121 of the lower fixation plate 120 and the rounded or scalloped profile of the convex edge portion 141 of the upper fixation plate 140 also allow the lower fixation plate 120 and the upper fixation plate 140 to be attached to the intervertebral fusion device 10 when the intervertebral fusion device 10 is in an anterior lordotic adjustment configuration or an over-lordotic adjustment configuration (e.g., 20-30 degrees of lordosis). FIGS. 9A-9C The attachment of the lower fixation plate 120 and the upper fixation plate 140 and the fasteners 122, 142 to the intervertebral fusion device 10 in the contracted configuration, the fully expanded configuration, and the anterior lordotic adjustment configuration are shown, respectively. For ease of description and illustration, the dimensions set forth below relate to the following embodiment: a bi-axially adjustable intervertebral fusion device 10 is placed between adjacent vertebrae via a lateral lumbar interbody fusion (LLIF) procedure, expanding or adjusting lordosis by operating the two drive mechanisms along the anterior and / or posterior sides of the patient, respectively, to achieve a configuration suitable for sagittal balance for the patient. One of ordinary skill in the art will appreciate that the intervertebral fusion device can be placed via an anterior lumbar interbody fusion (ALIF) or a posterior lumbar interbody fusion (PLIF), and expanding or adjusting lordosis by operating the drive mechanisms along the lateral and / or contralateral sides, respectively, to achieve a desired coronal balance or correct for coronal imbalance for the patient.

[0074] FIG. 9A The intervertebral fusion device 10 is shown contracted to an embodiment having a height at the anterior side ("anterior height") of 8.4 mm, a height at the posterior side ("posterior height") of 8.4 mm, and an angle between the upper shell member and the lower shell member ("lordosis") of 0 degrees. The concave and convex profiles of the edge portions allow the modular lower fixation plate 120 and the modular upper fixation plate 140 to be inserted and attached to the intervertebral fusion device 10, respectively. FIG. 9BAn embodiment of intervertebral fusion device 10 is shown 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. Attaching modular lower fixation plate 120 and modular upper fixation plate 140 to intervertebral fusion device can stabilize and prevent migration of intervertebral fusion device 10 in the fully expanded configuration. FIG. 9C An embodiment of intervertebral fusion device 10 is shown in an over-lordosis adjusted configuration with an anterior height of 17.1 mm, a posterior height of 7.2 mm, and a lordosis of 30 degrees. Attaching modular lower fixation plate 120 and modular upper fixation plate 140 to intervertebral fusion device 10 can stabilize and prevent migration of intervertebral fusion device in the over-lordosis adjusted configuration. In contrast FIG. 9C With FIG. 9B the passage geometry in lower fixation plate 120 allows lower fixation plate 120 to "pivot" around posterior drive shaft 24 prior to final attachment (note the different position of anterior drive shaft 26 in the passage geometry in lower fixation plate 120), thereby allowing lower fixation plate 120 to be angled relative to intervertebral fusion device 10 to provide optimal positioning of the apertures in lower fixation plate 120 and, thus, optimal fastener trajectories. Additionally, the apertures in lower fixation plate 120 and the apertures in upper fixation plate 140 can be configured or machined such that the axes of the apertures can be angled to the lower and upper fixation plates, respectively, as will be described in more detail in connection with FIGS. 16A-16B The angled apertures in lower fixation plate 120 and upper fixation plate 140 and the selection of fasteners (e.g., the rounded head portion of the fasteners) allow fasteners 122, 142 to have different trajectories in the caudal direction and the cephalad direction, e.g., from 0 degrees to 15 degrees, as shown in FIGS. 16A and 16B, respectively. It should be noted that the specific dimensions and angles provided above are for thorough understanding of the various embodiments of the present disclosure and are not intended to limit the scope of the claims. FIGS. 9A-9C

[0075] The dual-axially adjustable intervertebral fusion device or apparatus 100 with modular fixation can be used in the treatment of various spinal conditions, including but not limited to degenerative disc disease (DDD), spondylolisthesis, spondylolysis (Stage 1), etc. As FIGS. 10A-10B ​As shown in FIG. 1, in use, the modular lower fixation plate 120 and the modular upper fixation plate 140 can be inserted and attached in place to the interbody fusion device 10. For example, the interbody fusion device 10 in the collapsed configuration can first be inserted and placed between adjacent vertebrae 72, 74 via a suitable surgical procedure using an operating instrument. Suitable surgical procedures for placing the interbody fusion device 10 include lateral lumbar interbody fusion (LLIF) surgery, anterior lumbar interbody fusion (ALIF) surgery, posterior lumbar interbody fusion (PLIF) surgery, and any other suitable surgical procedure performed in the lumbar or other region of the spine. Various suitable operating instruments are described in U.S. Application Serial No. 15 / 661,435, filed July 17, 2017, entitled “Surgical Operating Instrument for Expandable and Adjustable Lordosis Interbody Fusion Systems,” and U.S. Application Serial No. 16 / 035,637, filed July 15, 2018, entitled “Surgical Operating Instrument for Expandable and Adjustable Lordosis Interbody Fusion Systems,” the disclosures of all of which are incorporated herein in their entireties. The interbody fusion device 10 can be expanded and / or lordosis adjusted using the operating instrument 70, thereby forming a suitable configuration between the adjacent vertebrae 72, 74. By way of example, the operating instrument 70 can connect the interbody fusion device 10 via the external threads 25 on the end portion of the posterior drive shaft 24 and the external threads 25 on the end portion of the anterior drive shaft 26, and expand or lordosis adjust the interbody fusion device 10 by engaging the female feature 27 in the end portion of the posterior drive shaft 24 and the female feature 27 in the end portion of the anterior drive shaft 26. FIG. 1A ) to the interbody fusion device 10.

[0076] The modular upper fixation plate 140 can then be introduced to the target region and attached to the interbody fusion device 10 by the same surgical method used to place the interbody fusion device 10. According to embodiments of the present disclosure, the operating instrument 70 used to place and operate the interbody fusion device 10 can be used to insert and attach the modular upper fixation plate 140. For example, the surgeon can engage the attachment locking mechanism 150 FIGS. 4A-4Dthread at the locking receptacle 150a of the locking attachment mechanism 150 to connect the upper fixation plate 140 with the operating instrument 70, introduce the upper fixation plate 140 to the target area through the same surgical procedure, and insert the protruding portion of the upper fixation plate 140 into the intervertebral fusion device 10. The intervertebral fusion device 10 can be locked to the upper fixation plate 140 by actuating the attachment locking mechanism 150 using the operating instrument 70.

[0077] After or before the insertion and attachment of the modular upper fixation plate 140, the modular lower fixation plate 120 can be introduced to the target area and attached to the intervertebral fusion device 10 using the same operating instrument 70 through the same surgical procedure for placing the intervertebral fusion device 10. For example, the surgeon can connect the lower fixation plate 120 with the operating instrument 70 via a thread disposed at the locking receptacle 130a of the locking attachment mechanism 130 FIGS. 3A-3D to connect the lower fixation plate 120 with the operating instrument 70, introduce the lower fixation plate 120 to the target area through the same surgical procedure, and insert the male geometry 126 in the lower fixation plate 120 into the female geometry 27 in the end portion of the posterior drive shaft 24. Optionally, the lower fixation plate 120 can be pivoted about the posterior drive shaft 24 to adjust or provide an optimal position of the aperture 124 in the lower fixation plate 120 for an optimal fastener trajectory before the 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 intervertebral fusion device 10 can then be further locked to the lower fixation plate 120 by actuating the attachment locking mechanism 130 using the operating instrument 70.

[0078] Next, fasteners 122, 142, such as spinal screws, can be inserted through the apertures in the upper fixation plate 140 and the lower fixation plate 120 and screwed into the first vertebral body 72 and the second vertebral body 74, respectively. Once the fasteners 122, 142 are driven all the way and the heads of the fasteners are received in the counterbores of the apertures in the fixation plates, the fastener locking mechanisms in the upper fixation plate 140 and the lower fixation plate 120 are automatically actuated, thereby prohibiting the fasteners 122, 142 from backing out. The intervertebral fusion device 10 can be stabilized and prevented from migrating in the vertebral bodies 72, 74, as shown in FIGS. 11A-11B .

[0079] In conjunction with FIGS. 2A-11BEmbodiments of a dual-axially adjustable intervertebral fusion device or apparatus 100 with modular fixation are described. Beneficially, the intervertebral fusion device 100 with modular fixation can provide stability and prevent migration of the intervertebral fusion device in a highly expanded configuration and / or an over- lordotic adjustment configuration, thereby safely facilitating fusion between adjacent vertebral bodies. The modular superior fixation plate and the modular inferior fixation plate allow for attachment of one or both plates to the intervertebral fusion device in any suitable size and configuration after adjustment of the intervertebral fusion device, and optionally prior to implantation. The modular fixation plates are capable of being inserted and attached to the intervertebral fusion device via a single surgical procedure and patient position, thereby minimizing disruption to the patient's anatomy. If desired, the modular design also affords the surgeon the option of using the fixation assembly after an increased interbody configuration, during surgery, or during a stop. The modular inferior fixation plate 120 and the modular superior fixation plate 140 follow the anterior and posterior angles of the inferior shell member 32 and the superior shell member 34 of the intervertebral fusion device 10 from 0 degrees to 15 degrees, or from 0 degrees to 30 degrees of anterior and posterior angles measured from the center of the modular inferior fixation plate to the center of the modular superior fixation plate, respectively, thereby allowing for desired screw trajectories and placement into the cortical bone.

[0080] The intervertebral fusion device 100 with fixation allows the surgeon to set the intervertebral fusion device in a precise configuration for any patient, particularly in a highly expanded configuration for any height and in an over-lordotic adjustment configuration for any angle between 20° and 30° for any patient, without further disruption to the patient's anatomy caused by additional surgery required for independent screw and plate systems. Although the lumbar section of the spine can not require lordotic (negative lordotic) adjustment, the intervertebral fusion device 100 with fixation has the ability to be adjusted to a kyphotic angle configuration and an over-kyphotic angle configuration. Thus, the intervertebral fusion device 100 with fixation can provide complete individualization for the patient, allowing the surgeon to adjust the intervertebral fusion device to any unique height and / or angle (such as 23.4°) required by the patient's spinal balance profile. Conventional techniques can allow the intervertebral fusion device to be set in only a few different lordotic configurations, such as 20°, 25°, 30° lordotic configurations, and independent screw and plate systems must be used through additional surgery to stabilize the fusion device in a lordotic configuration.

[0081] The interbody fusion device 100 with fixation can also improve surgical efficiency. Typically, surgeons must perform effective trials or sizing of the implant to determine the required implant size for a specific patient. According to embodiments of this disclosure, the interbody fusion device can begin with a small constriction height and then increase in height in situ. This allows for streamlining or significantly shortening of the trial process, which in turn reduces the harsh and rough effects associated with the trial. Modular fixation plates can be used for excessive lordosis configurations, thereby reducing the need for additional fixation plates and bone screws independent of the interbody fusion device. The use of modular fixation plates causes less disruption to the patient's anatomy. Once the surgeon has adjusted the interbody fusion device to the patient's unique spinal profile, such as sagittal balance profile, disc height, and lordosis, the modular fixation plate can be inserted and attached to the fusion device using the same surgical method to fix the fusion device to the vertebral body, without requiring additional surgical methods to place a separate plate and screw fixation system anterior to the spine.

[0082] The modular design of the fixation components also offers benefits related to manufacturing and hospital management. This reduces inventory. A single set of lower and upper fixation plates can work with biaxial interbody fusion devices of any size and configuration, thereby significantly reducing manufacturing and operating costs. The use of a single set of lower and upper fixation plates with biaxial interbody fusion devices of any size and configuration simplifies the need for tracking by requiring only one set of fixation plates in the hospital or operating room.

[0083] Biaxially adjustable combined spinal system

[0084] Reference FIGS. 12A-19B An example of a biaxially adjustable spinal system 200 according to embodiments of the present disclosure will now be described. The use of a single fixation plate in the spinal system allows for in-situ attachment of fixation components to the intervertebral fusion device after the device has been adjusted to a desired configuration in adjacent vertebrae. The single fixation plate may be constructed of a material of sufficient strength, such as titanium, stainless steel, or other metals or metal alloys, to provide corrective support or supplementary fixation in addition to providing stability and preventing migration of the intervertebral fusion device. As used herein, the term "supplementary fixation" refers to an embodiment of a single fixation plate used as an orthotics capable of holding adjacent vertebrae fixed or immobilizing adjacent vertebrae until arthroplasty (bone grafting fusion) is performed.

[0085] like FIGS. 12A-12E As shown, the spinal system 200 includes an interbody fusion device 10 and a fixation assembly 210. The interbody fusion device 10 can be combined with the above-mentioned... FIGS. 1A-1CThe described device 10 is the same or similar. Alternatively, the intervertebral fusion device 10 can be any suitable dual-axial adjustable intervertebral fusion device available from various manufacturers that can be further adapted or modified for use with the fixation assembly 210.

[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 intervertebral fusion device 10. The single fixation plate 220 is provided with at least a first aperture 226 configured for insertion of the first fastener 226 therethrough for fixation to a first vertebral body and a second aperture 228 configured for insertion of the second fastener therethrough for fixation to a second vertebral body. As used herein, the term "single" refers to a fixation plate provided with at least two apertures for insertion of at least two fasteners that are capable of stabilizing the intervertebral fusion device between two adjacent vertebral bodies. However, the use of the term "single" does not preclude other parts assembled to the fixation plate for performing other functions such as locking and the like. As used herein, the term "fixation plate" includes reference to a plate member or a plate assembly comprising a plate member and other components or mechanisms assembled to the plate member. Although two fasteners and two apertures in the single fixation plate are shown for illustrative purposes, other embodiments can include more than two fasteners and more than two apertures in the fixation plate. In addition, FIGS. 12C-12D An assembled view of the spinal system 200 is shown with the single fixation plate 220 attached to the intervertebral fusion device 10 with the first fastener 222 and the second fastener 224 inserted through the apertures in the fixation plate. It should be noted that in use, the single fixation plate 220 can be attached to the intervertebral fusion device 10 in situ or after the intervertebral fusion device 10 has been inserted in the patient and placed between adjacent vertebrae. If desired, the single fixation plate 220 can also be attached to the intervertebral fusion device 10 prior to implantation, provided that the intervertebral fusion device is adjusted prior to implantation. The fixation assembly 210 will be described in greater detail below. FIG. 18 It is shown that the single fixation plate 220 is inserted in the patient and attached to the intervertebral fusion device by the use of an instrument after the intervertebral fusion device has been placed between adjacent vertebrae, expanded between the adjacent vertebrae and / or lordotically adjusted to an appropriate configuration.

[0087] Reference is made to FIGS. 13A-13FA single fixation plate 220 can be configured to attach to the intervertebral fusion device 10. For example, the single fixation plate 220 can be provided with geometric features configured to attach to the intervertebral fusion device 10 and prevent unwanted rotation of the drive shafts 24 and 26 of the intervertebral fusion device 10. According to certain embodiments of the present disclosure, the single fixation plate 220 in the posterior side can include a first male geometric feature 230 and a second male geometric feature 232 spaced apart from each other FIG. 13C and FIG. 13F ). The first male geometric feature 230 and the second male geometric feature 232 can be configured to be inserted into a female geometric feature 27 in an end portion of a first drive shaft (e.g., a posterior drive shaft) 24 and a female geometric feature 27 in an end portion of a second drive shaft (e.g., an anterior drive shaft) 26, respectively, of the intervertebral fusion device 10. By way of example, the first male geometric feature 230 and the second male geometric feature 232 can have a male hexalobular feature that can be tightly fitted into a female hexalobular feature 27 in an end portion of the first drive shaft 24 and a female hexalobular feature 27 in an end portion of the second drive shaft 26 to prevent unwanted rotation of the first drive shaft 24 and the second drive shaft 26. The first male geometric feature and the second male geometric feature can have other mating features, and the above hexalobular feature example is provided for illustrative purposes. An annular groove 231, 233 around each of the first male geometric feature 230 and the second male geometric feature 232 can be provided to receive or accommodate the end portion of the first drive shaft 24 and the end portion of the second drive shaft 26 of the intervertebral fusion device 10 when the single fixation plate 220 is attached to the intervertebral fusion device 10. FIG. 12E The attachment of the single fixation plate 220 to the intervertebral fusion device 10 is shown, where the first male geometric feature 230 and the second male geometric feature 232 in the single fixation plate 220 are received in the female geometric feature 27 in the end portion of the first drive shaft 24 and the female geometric feature 27 in the end portion of the second drive shaft 26, respectively, and the end portion of the first drive shaft 24 and the end portion of the second drive shaft 26 are fitted in the annular grooves in the single fixation plate 230.

[0088] Referring to FIGS. 13C-13F, the single fixation plate 220 can alternatively or additionally include a protruding portion 234 configured to be inserted into the intervertebral fusion device 10 to stabilize the intervertebral fusion device 10 placed between adjacent vertebrae and prevent migration of the intervertebral fusion device 10. According to certain embodiments of the present disclosure, the protruding portion 234 in the single fixation plate 220 can have a geometry configured to closely fit with the internal components of the intervertebral fusion device 10 to limit unwanted movement of the intervertebral fusion device 10. By way of example, the protruding portion 234 can have a geometry that is generally rectangular prismatic in shape, which can be closely inserted in the ramped geometry of the thrust bearing 60 of the intervertebral fusion device 10 FIG. 1A ) to prohibit or minimize unwanted translational movement of the intervertebral fusion device 10 in any of the lateral, posterior, anterior directions. The protruding portion 234 can also be in any other suitable shape or form, such as a cuboid, semi-cylindrical or polygonal prismatic shape, etc. FIGS. 14A-14B The protruding portion 234 of the single fixation plate 220 inserted in the intervertebral fusion device 10 is shown along with the attachment locking mechanism 240 in the unlocked state to be further described below FIG. 14A ) and the attachment locking mechanism 240 in the locked state FIG. 14B ) to be further described below.

[0089] Referring to FIGS. 13A-13F , the single fixation plate 220 can include an attachment locking mechanism 240 that is capable of engaging to lock the intervertebral fusion device 10 or to secure the attachment of the single fixation plate 220 to the intervertebral fusion device 10. According to certain embodiments of the present disclosure, the attachment locking mechanism 240 can be similar to the attachment locking mechanism 130 shown in FIGS. 3A-3D or the attachment locking mechanism 230 shown in FIGS. 4A-4DThe attachment locking mechanism 240 in the single fixation plate 220 can include a lock receptacle 240a, a rod 240b, a compression spring 240c loaded on the rod 240b and held in the lock receptacle 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 feature for receiving a driving tool to actuate the attachment locking mechanism 240. For example, the proximal end portion of the rod 240b can be provided with a female hex feature for receiving a male hex feature of a driver. In use, a user can press the rod 240b by the driver to displace the latch 240d coupled to the distal end portion of the rod 240b, allowing the latch to rotate and hook onto a component in the intervertebral fusion device 10. The compression spring 240c loaded on the rod 240b exerts a force on the latch 240d, and after the driver is released, the latch 240d tightens the attachment of the lower fixation plate 220 to the intervertebral fusion device 10, or locks the intervertebral fusion device 10 to the single fixation plate 220. The receptacle 240a of the attachment locking mechanism 240 can be provided with a feature, such as a thread, configured for connection with an operating instrument for actuating the attachment locking mechanism 240 and / or placing the single fixation plate in a patient anatomy. FIG. 14A The attachment locking mechanism 240 is shown in an unlocked state, with the latch 240d in an unlocked position. FIG. 14B The attachment locking mechanism 240 is shown in a locked state, with the latch 240d in a locked position hooking onto a component (e.g., a thrust bearing) of the intervertebral fusion device 10.

[0090] Referring to FIGS. 13A-13B The single fixation plate 220 can also include a first fastener locking mechanism 242 and a second fastener locking mechanism 244. The first and second fastener locking mechanisms in the single fixation plate 220 can be the same as or similar to the fastener locking mechanisms shown in FIGS. 3A-3D or FIGS. 4A-4DThe first fastener locking mechanism 242 in the single fixation plate 220 can include a locking member 242a received in a recess 242b adjacent the first aperture 226, a compression spring 242c loaded on a portion of the locking member 242a, and a retainer 242d connected to a portion of the locking member 242a. The retainer 242d retains the locking member 242a in the recess 242b via the compression spring loaded on the locking member 242a and is slidable relative to the single fixation plate 220 with the locking member 242a, allowing the locking member 242a to be extended beyond the aperture 226 and / or retracted from the aperture 226 when in use. The second fastener locking mechanism 244 can be the same as or similar to the first fastener locking mechanism 242. Alternatively, the first fastener locking mechanism 242 and the second fastener locking mechanism 244 are the same as or similar to the fastener locking mechanisms to be described in connection with the fixation plate 420 and the fixation plate 440. FIGS. 27A-27B The fastener locking mechanisms 426 in the fixation plate 420 and the fastener locking mechanisms 446 in the fixation plate 440 are the same as or similar to the fastener locking mechanisms described above.

[0091] FIGS. 15A-15B Some aspects of the first fastener locking mechanism 242 in the single fixation plate 220 are depicted more clearly. The compressed state and the extended (free) state of the compression spring allow the spring-loaded locking member 242a to have an unlocked / open position and a locked position, respectively. In the extended state or free state of the compression spring, the locking member 242a is partially extended beyond 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 member 242a is forced away from the aperture 226, allowing the fastener 222 to be fastened, e.g., screwed into a vertebral body. Once the fastener is screwed 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 member 242a at least partially springs back over the fastener head, preventing the fastener 222 from backing out. The fastener locking mechanism 242 of the present disclosure allows for "zero-step" locking, as the surgeon does not need any surgical instruments or steps to engage the fastener locking mechanism 242 to cover the fastener head to prevent the fastener from backing out, e.g., unscrewing from the vertebral body.

[0092] FIG. 16A and FIG. 16BAs shown, 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 parallel to the surface of the fixation plate. Similarly, the centerline 228 of the second aperture 228 can be angled from 0 degrees to 15 degrees relative to a reference plane, such as a reference plane parallel to the surface of the single fixation plate. The angled apertures allow the fasteners to be inserted therethrough with an angled trajectory, thereby providing optimal fastening from the fasteners to the vertebral bodies. The first aperture 226 and the second aperture 228 can be configured to allow the first fastener 222 and the second fastener 224 to be angled from 0 degrees to 15 degrees, for example, in a caudal direction or in a cranial direction or in any other direction, respectively. The first aperture 226 and the second aperture 228 can include a counter sunk portion or a countersunk portion configured to receive the head of the first fastener and the head of the second fastener. The head of the fastener can have a spherical shape as shown or any other suitable shape, such as a tapered shape or a cylindrical shape. Examples of fasteners include, but are not limited to, spinal expanding head screws, spinal locking screws, spinal self-locking screws, spinal shaft screws, spinal nails, spinal hooks, and any other threaded or unthreaded fasteners. Figures 15A-15B

[0093] Figures 17A-17C As illustrated, the single fixation plate 220 can be attached to the intervertebral fusion device 10 in various configurations, including a collapsed configuration, a fully expanded configuration, and an anterior lordosis adjustment configuration or an overlordosis adjustment configuration. Although the lumbar section of the spine can not require a kyphosis (negative lordosis) adjustment, the intervertebral fusion device 10 can be connected with the single fixation plate assembly in a kyphosis angle configuration and an overkyphosis angle configuration. By way of example, Figure 17A As shown, the single fixation plate 220 can be attached to the intervertebral fusion device 10 in a collapsed configuration with an anterior height of 8.4 mm, a posterior height of 8.4 mm, and an anterior lordosis of 0 degrees. Figure 17B An example is shown of the single fixation plate 220 attached to the intervertebral fusion device 10 in a fully expanded configuration with an anterior height of 16.1 mm, a posterior height of 16.1 mm, and an anterior lordosis of 0 degrees. Figure 17C An example is shown of the single fixation plate 220 attached to the intervertebral fusion device 10 in an overlordosis adjustment configuration with an anterior height of 17.1 mm, a posterior height of 7.2 mm, and an anterior lordosis of 30 degrees. The angled first aperture and the angled second aperture in the single fixation plate 220 allow the screw angles to be up to 15 degrees in the caudal direction and the cranial direction, respectively, as shown in Figures 17B-17C

[0094] ​​The biaxially adjustable spinal system 220 can be used in the treatment of various spinal diseases, including but not limited to degenerative disc disease (DDD), anterior spinal displacement, posterior spinal displacement, trauma, tumors, deformities, pseudoarthritis, and previously failed fusions. In use, such as... Figure 18 As shown, a single fixation plate 220 can be inserted and attached in situ to the interbody fusion device 10. For example, the interbody fusion device 10 in a retractable configuration can first be inserted and placed between adjacent vertebrae 72, 74 via a suitable surgical procedure using a manipulation instrument 70. Suitable surgical procedures for introducing the interbody fusion device 10 into the patient's anatomy include lateral lumbar interbody fusion (LLIF), anterior lumbar interbody fusion (ALIF), posterior lumbar interbody fusion (PLIF), and any other suitable surgical procedure performed in the lumbar or other regions of the spine. Various suitable operating instruments are described in the following: U.S. Serial No. 15 / 661,435, filed July 17, 2017, entitled “Surgical Operating Instrument for Expandable and Adjustable Lordosis Interbody Fusion Systems”; and U.S. Serial No. 16 / 035,637, filed July 15, 2018, entitled “Surgical Operating Instrument for Expandable and Adjustable Lordosis Interbody Fusion Systems”, the entire contents of which are incorporated herein by reference. The interbody fusion device 10 can be expanded and / or lordotically adjusted using the operating instrument 70 to create a suitable configuration between adjacent vertebrae 72, 74. By way of example, the operating instrument 70 can be connected to the intervertebral fusion device 10 via the external thread 25 on the end portion of the rear drive shaft 24 and the external thread 25 on the end portion of the front drive shaft 26, and via the female feature 27 in the end portion of the rear drive shaft 24 and the female feature 27 in the end portion of the front drive shaft 26. Figure 1A The interbody fusion device 10 can be expanded or lordotically adjusted. The interbody fusion device can be expanded and / or lordotically adjusted to a configuration suitable for the patient being treated.

[0095] The single fixation plate 220 can then be introduced to the target area via the same surgical procedure for inserting and placing the intervertebral fusion device 10 and attached to the intervertebral fusion device 10. According to embodiments of the present disclosure, the operating instrument 70 used to place and operate the intervertebral fusion device 10 can be used to insert and attach the single fixation plate 220. By way of example, the surgeon can connect the single fixation plate 220 to the operating instrument 70 via threads provided at the locking receptacle 240a of the attachment locking mechanism 240, introduce the single fixation plate 220 to the target area via the same surgical procedure, align the first male geometry 230 and the second male geometry 232 with the female geometry 27 in the end portion of the posterior drive shaft 24 and the female geometry 27 in the end portion of the anterior drive shaft 26 of the intervertebral fusion device 10, and insert the single fixation plate to the intervertebral fusion device 10. The intervertebral fusion device 10 can also be further locked to the single fixation plate 220 by actuating the attachment locking mechanism 240 using the operating instrument 70.

[0096] Fasteners 222, 224, such as bone screws, can then be inserted through the apertures in the single fixation plate 220 and screwed into the first and second vertebral bodies 72, 74, respectively. Once the fasteners 222, 224 are driven all the way and the heads of the fasteners 222, 224 are received in the apertures in the single fixation plate 220, the fastener locking mechanisms 242, 244 in the single fixation plate 220 are automatically actuated to lock the fasteners 222 and 224, thereby prohibiting the fasteners 222, 224 from backing out. The intervertebral fusion device 10 can be stabilized and prevented from migrating in the vertebral bodies 72, 74, as shown in FIG. 6B, for example. Additionally, the single fixation plate 220 can be constructed of a metal, such as stainless steel or other metal or alloy, having sufficient strength to provide supplemental fixation for holding the adjacent vertebrae 72 and 74 fixed or immobilizing movement of the adjacent vertebrae to promote safe bony fusion. Figures 19A-19B

[0097] In conjunction with the single fixation plate 220, the intervertebral fusion device 10 can be used to treat degenerative disc disease, spondylolisthesis, spondylosis (stage 1), etc. The single fixation plate 220 can be used to provide stability and promote fusion between adjacent vertebral bodies without the further need for supplemental posterior fixation. The single fixation plate 220 can be constructed with sufficient strength to provide corrective support or supplemental fixation. The single fixation plate 220 can be implanted and configured to attach to the intervertebral fusion device via a single surgical procedure and a single patient position, thereby minimizing disruption to the patient's anatomy. The geometry, such as the male geometry in the single fixation plate, can be used as a secondary safety lock for the dual axial intervertebral fusion device. The single fixation plate 220 can attach to all footprints and configurations of the intervertebral fusion device. Figures 12A-19B Embodiments of a dual axial adjustable spinal system 200 including a single fixation plate are described. Advantageously, the spinal system 200 can provide stability and promote fusion between adjacent vertebral bodies without the further need for supplemental posterior fixation in treating degenerative disc disease, spondylolisthesis, spondylosis (stage 1), etc. The single fixation plate can be constructed with sufficient strength to provide corrective support or supplemental fixation. The single fixation plate 220 can be implanted and configured to attach to the intervertebral fusion device via a single surgical procedure and a single patient position, thereby minimizing disruption to the patient's anatomy. The geometry, such as the male geometry in the single fixation plate, can be used as a secondary safety lock for the dual axial intervertebral fusion device. The single fixation plate 220 can attach to all footprints and configurations of the intervertebral fusion device.

[0098] ​As in other embodiments of the device 100, the spinal system 200 allows a surgeon to set an intervertebral fusion device in any patient in a precise configuration, particularly in a highly expanded configuration in any height and in a hyperlordotic adjustment configuration in any angle between 20° and 30°, without causing further damage to the patient's anatomy from additional surgery required by independent screw and plate systems. Thus, the spinal system 200 can provide full personalization to a patient, allowing a surgeon to adjust an intervertebral fusion device to any unique height and / or angle (e.g., 23.4°) required by the patient's spinal balance profile. Conventional techniques can allow an intervertebral fusion device to be set in only a small number of predetermined lordotic configurations, such as 20°, 25°, 30° lordotic configurations, and independent screw and plate systems must be used through additional surgical procedures to stabilize the fusion device in a lordotic configuration.

[0099] The spinal system 200 can also improve surgical efficiency. Typically, a surgeon must perform a trial or size the implant to determine the size of the implant required for a particular patient. According to embodiments of the present disclosure, an intervertebral fusion device can start at a smaller collapsed height and then increase in height. This allows the trial process to be streamlined or significantly shortened, which in turn can reduce the rough and invasive effects associated with the trial process. Once the surgeon has adjusted the fusion device to the patient's unique spinal profile, such as the intervertebral disc height and the lordotic sagittal balance profile, a single fixation plate can be inserted and attached to the intervertebral fusion device through the same surgical procedure to secure the fusion device to the vertebral bodies with less damage to the patient's anatomy. The single fixation plate can also provide supplemental fixation, eliminating the need for separate plate and screw fixation systems through separate surgical procedures for the patient's spine.

[0100] The spinal system 200 also provides benefits related to manufacturing and hospital administration. The spinal system 200 can reduce inventory. A single set of fixation plates can work with any size and configuration of the biaxially adjustable intervertebral fusion device made, thereby significantly reducing manufacturing and operational costs. The use of a single set of fixation plates with any size and configuration of the biaxial intervertebral fusion device simplifies the need for tracking by only tracking one set of fixation plates in the hospital or operating room.

[0101] Biaxially adjustable variable spinal system

[0102] Reference Figures 20A-25B An example biaxially adjustable spinal system 300 according to embodiments of the present disclosure will now be described. In Figures 20A-25B The spinal system 300 shown in FIG. 1 1 is in many respects similar to the spinal system 200 described above in connection with FIGS. 1-10. Figures 12A-19BThe described spinal system 200 is similar. For example, the spinal system 300 includes a single fixation plate for attachment in situ to an intervertebral fusion device after the intervertebral fusion device has been adjusted to a desired configuration in adjacent vertebrae. The single fixation plate can be constructed of a material having sufficient strength to provide supplemental fixation in addition to providing stability and preventing migration of the intervertebral fusion device. Some unique aspects of the spinal system 300 are set forth below.

[0103] Referring to Figures 20A-20D , the spinal system 300 includes an intervertebral fusion device 10 and a fixation assembly 310. The intervertebral fusion device 10 can be the same as or similar to the device 10 described above in connection with Figures 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 is provided with at least a first aperture 326 configured for insertion of the first fastener 310 therethrough for fixation to a first vertebral body and at least a second aperture 328 configured for insertion of the second fastener 324 therethrough for fixation to a second vertebral body. The single fixation plate 320 is configured to be inserted to the intervertebral fusion device 10, thereby allowing the single fixation plate to be attached in situ to the intervertebral fusion device 10. If desired, the single fixation plate assembly 320 can also be attached to the intervertebral fusion device 10 prior to implantation, provided that the intervertebral fusion device has been adjusted prior to implantation. The single fixation plate 320 can have an attachment locking mechanism 340 configured to secure attachment of the single fixation plate 320 to the intervertebral fusion device 10. According to certain embodiments, the single fixation plate 320 is capable of clockwise or counterclockwise rotation relative to the intervertebral fusion device 10, as shown in Figure 20D . The ability of the single fixation plate 320 to rotate relative to the intervertebral fusion device 10 allows for adjustment of the position of the first aperture 326 and the position of the second aperture 328 relative to the vertebral bodies, thereby providing optimal fastener trajectories for improved fastener fixation to the vertebral bodies.

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

[0105] Referring toFigures 21C-21F The single fixation plate 320 can also include a protruding portion 334 configured to be inserted into the intervertebral fusion device 10 or to allow the single fixation plate 320 to attach with the intervertebral fusion device 10 to stabilize the intervertebral fusion device 10 placed between adjacent vertebrae and / or to prevent migration of the intervertebral fusion device 10. Attachment of the single fixation plate 320 to the intervertebral fusion device 10 restricts unwanted translational movement of the intervertebral fusion device in any of the lateral, anterior, and posterior directions. Attachment of the single fixation plate 320 to the intervertebral fusion device 10 can be fastened or locked by an attachment locking mechanism 340, as shown in Figures 22A-22B . Figure 22A Attachment of the single fixation plate 320 to the intervertebral fusion device 10 and the attachment locking mechanism 340 in the unlocked state are shown. Figure 22B Attachment of the single fixation plate 320 to the intervertebral fusion device 10 and the attachment locking mechanism 340 in the locked state are shown, where the latch 340d of the attachment locking mechanism 340 hooks onto a component in the intervertebral fusion device 10 (e.g., a thrust bearing).

[0106] According to certain embodiments of the present disclosure, the protruding portion 334 is configured to allow the single fixation plate to be able to rotate relative to the intervertebral fusion device 10. For example, the protruding portion 334 can have a geometry that is generally semi-cylindrical in shape that can be received in an internal component, such as a channel geometry built into an inner surface of the upper shell member 34 of the intervertebral fusion device 10. The semi-cylindrical geometry of the protruding portion 334 allows the single fixation plate 320 to be able to rotate relative to the intervertebral fusion device 10, thereby allowing the single fixation plate 320 to adjust the orientation and angle of the single fixation plate 320 prior to being fastened to the vertebral body. According to certain embodiments of the present disclosure, the single fixation plate 320 can be able to rotate clockwise or counterclockwise at an angle from 0 degrees to 11 degrees relative to an imaginary plane that includes the first drive shaft 24 and the second drive shaft 26. Figure 23A is an end view showing the single fixation plate 320 angled relative to the intervertebral fusion device 10. Figure 23B is a cross-sectional view showing the single fixation plate 320 angled relative to the intervertebral fusion device 10. The lateral sides of the single fixation plate 320 can be configured to accommodate the first drive shaft 24 and the second drive shaft 26 of the intervertebral fusion device 10 as the single fixation plate 320 is rotated relative to the intervertebral fusion device 10. As Figures 21A-21F shown in FIG. 6, recesses, cutouts, or the like 346 can be provided at the lateral sides of the single fixation plate 320 to allow the single fixation plate 320 to be angled relative to the intervertebral fusion device 10. Figures 23C-23Dis an isometric view showing the recess or cutout 346 in the lateral side of the single fixation plate 320, allowing the single fixation plate to angle without interfering with the drive shafts 24 and 26 in the intervertebral fusion device 10.

[0107] Figures 24A-24D It is illustrated that the single fixation plate 320 can be attached to the intervertebral fusion device 10 in various configurations, including a collapsed configuration, a fully expanded configuration, and an anterior lordosis adjustment configuration or an overlordosis adjustment configuration. By way of example, Figure 24A It is shown that the single fixation plate 320 can be attached to the intervertebral fusion device 10 in a collapsed configuration with an anterior height of 8.4 mm, a posterior height of 8.4 mm, and an anterior lordosis of 0 degrees. Figure 24B It is shown that the single fixation plate 320 can be attached to the intervertebral fusion device 10 in a fully expanded configuration with an anterior height of 16.1 mm, a posterior height of 16.1 mm, and an anterior lordosis of 0 degrees. Figure 24C It is shown that the single fixation plate 320 can be attached to the intervertebral fusion device 10 in an overlordosis configuration with an anterior height of 17.1 mm, a posterior height of 7.2 mm, and an anterior lordosis of 30 degrees. Figure 24D It is shown that the single fixation plate 320 can be attached to the intervertebral fusion device 10 in an overlordosis configuration with an anterior height of 17.1 mm, a posterior height of 7.2 mm, and an anterior lordosis of 30 degrees. Figure 24D With 24C , Figure 24D the single fixation plate 320 in FIG. 6 is rotated at an angle of 11 degrees relative to an imaginary plane comprising the first drive shaft and the second drive shaft. The angle of the single fixation plate 320 allows for adjustment of the position of the apertures 326, 328 in the single fixation plate 320, for example, to adjust the position of the apertures 326, 328 to provide optimal fastener trajectories to the vertebral bodies depending on the expanded configuration and / or the anterior lordosis adjustment configuration of the intervertebral fusion device 10.

[0108] The dual-axial adjustable spinal system 300 can be used in the treatment of various spinal conditions, including but not limited to degenerative disc disease (DDD), spondylolisthesis, spondylolysis (Stage 1). Additionally, the fixation assembly 310 can also be used to provide supplemental fixation in the treatment of degenerative disc disease (DDD), spondylolisthesis, trauma (fracture or dislocation), curved deformities (scoliosis, kyphosis, and / or lordosis), tumors, pseudarthrosis, and failed prior fusion, trauma, tumor, deformity, pseudarthrosis, prior failed fusion, etc. The use, benefits, and advantages of the spinal system 300 are similar to those described above in connection with the spinal system 100. Figures 12A-19BThe described spinal system 200 provides similar uses, benefits, and advantages, and therefore detailed descriptions are omitted herein for the sake of brevity. One unique feature is the variable aspect of the single fixation plate 320 in the spinal system 300. Because of the lack of male geometry mating with female geometry in the drive shaft, the single fixation plate 320 is able to rotate in situ relative to the intervertebral fusion device 10, thereby allowing for adjustment of the position of the aperture in the single fixation plate 320. Figures 25A-25B An embodiment is shown in which the intervertebral fusion device 10 is secured in the vertebral bodies 72 and 74 by the single fixation plate 320.

[0109] Biaxially adjustable intervertebral fusion device with integral fixation

[0110] Referring to Figures 26A-31B A biaxially adjustable intervertebral fusion device or apparatus 400 with integral fixation will now be described in accordance with the present disclosure. The integral design allows the fixation plate to be implanted with the intervertebral fusion device and angularly adjusted by expanding and / or adjusting the intervertebral fusion device in situ, thereby providing stability and preventing migration of the intervertebral fusion device in the vertebral body.

[0111] As Figures 26A-26D The apparatus 400 generally includes an intervertebral fusion device 10 and a fixation assembly 410, as shown in Figures 1A-1C The described example biaxially adjustable intervertebral fusion device 10 can be the same or similar to that described above in connection with the spinal system 200. Alternatively, the fusion device 10 can be any other biaxially adjustable intervertebral fusion device available from various manufacturers that can be further adapted or modified for use with the fixation assembly 410.

[0112] The fixation assembly 410 includes a first or lower fixation plate 420 and a second or upper fixation plate 440. The fixation assembly 410 also includes a first fastener 424 and a second fastener 442. According to certain embodiments of the present disclosure, the lower fixation plate 420 is coupled to the lower shell member 32 and is configured to be placed with the intervertebral fusion device. Likewise, the upper fixation plate 440 is coupled to the upper shell member 34 and is configured to be placed with the interbody fusion device 10. In certain embodiments, the lower fixation plate 420 can be integrally formed with the lower shell member 32. For example, the lower fixation plate 420 and the lower shell member 32 can be formed as a single piece, or the lower fixation plate 420 can be manufactured as a separate piece and then welded to or integrated with the lower shell member 32. Alternatively, the lower fixation plate 420 can be formed as a separate piece and coupled to the lower shell member 32 by interference fit, threaded coupling, or any other suitable method. Likewise, the upper fixation plate 440 can be integrally formed with the upper shell member 34, for example, by being manufactured as a single piece or separate pieces and then welded together. Alternatively, the upper fixation plate 440 can be formed as a separate piece and coupled to the upper shell member 34 by interference fit, threaded coupling, or any other suitable method. The integral design allows the lower fixation plate 420 and the upper fixation plate 440 to be implanted with the intervertebral fusion device 10. The coupling of the lower fixation plate 420 to the lower shell member 32 and the coupling of the upper fixation plate 440 to the upper shell member 34 allow the lower fixation plate 420 and the upper fixation plate 440 to be angularly adjusted by expanding and / or adjusting the intervertebral fusion device 10 in situ.

[0113] The lower fixation plate 420 is provided with an aperture 424 configured to have the first fastener 422 inserted therethrough for fixation to the first vertebral body. The upper fixation plate 440 is provided with an aperture 444 configured to have the second fastener 444 inserted therethrough for fixation to the second vertebral body. According to certain embodiments of the present disclosure, one or both of the lower fixation plate 420 and the upper fixation plate 440 can be sized and / or shaped to minimize or reduce the profile of the fixation plate. The reduced profile of the lower fixation plate 420 and / or the upper fixation plate 440 allows for improved visualization of the apparatus 400 in the patient, for example, in a lateral view, particularly when implanted via a lateral approach. The reduced profile of the lower fixation plate 420 and / or the upper fixation plate 440 also facilitates insertion and placement of the apparatus 400 in the patient anatomy. By way of example, one or both of the lower fixation plate 420 and the upper fixation plate 440 can be in the form of a threaded ring or a stent, wherein the fastener apertures 424 and / or 444 are formed in or located near the periphery of the lower fixation plate 420 and / or the upper fixation plate 440, such that the overall profile of the lower fixation plate 420 and the upper fixation plate 440 can be minimized.

[0114] According to certain embodiments of the present disclosure, the apertures 424 in the lower fixation plate 420 and the apertures 442 in the upper fixation plate 440 can be configured to allow the trajectory of the first fasteners 422 and the second fasteners 442 to be adjustable in either a caudal direction or a cephalad direction, as shown in Figures 26C-26D FIG. 4B. By way of example, the apertures 424 in the lower fixation plate 420 and the apertures 444 in the upper fixation plate 440 can be cut such that the centerline of the aperture 424 and the centerline of the aperture 444 form an angle of, for example, 0 degrees to 15 degrees with respect to a reference plane, such as the lower shell member or the upper shell member, as described above in connection with Figures 16A-16B FIG. 4B. Alternatively or additionally, the first fasteners 422 and the second fasteners 444 can be sized or shaped to allow the fastener trajectory to be adjustable. For example, the first fasteners 422 and the second fasteners 442 can have head portions that are spherical in shape or tapered in shape, as shown in Figure 28 FIG. 4B, thereby allowing the fastener trajectory to be adjustable. In general, the trajectory of the first fasteners 422 and the trajectory of the second fasteners 442 can be angled from 0 degrees to 15 degrees, respectively, in either a caudal direction or a cephalad direction with respect to the lower shell member 32 or the upper shell member 34, respectively, to provide an optimal fastener trajectory to maximize or increase fastener tightening to the vertebral body.

[0115] Referring to Figures 26A-26D FIG. 4B, the lower fixation plate 420 can include a locking mechanism 426 for preventing the fasteners 422 from backing out. Likewise, the upper fixation plate 440 can include a locking mechanism 446 for preventing the fasteners 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 include a locking rod 446a received in a recess 446 adjacent the aperture 444 in the upper fixation plate 440 and an adapter 446c welded or attached to an end of the locking rod 446a to hold the locking rod in the recess and allow the locking rod to turn. As better observed in Figures 27A-27B FIG. 4B, the head of the locking rod 446a can have a rounded side portion 446a-1, a flat side portion 446a-2, and an end portion 446a-3 having a feature, such as a female hex feature, configured to receive a driver for actuating the locking mechanism 446. When the locking rod 446a is turned to set the locking mechanism 446 to an unlocked or open state, the head flat side portion 446a-2 faces the aperture 444 in the fixation plate 440, as shown in Figure 27A FIG. 4B, leaving the aperture 444 open to allow the fastener 442 to be inserted therethrough. When the fastener 442 is driven all the way into the vertebral body and the fastener head is received in the aperture 444, the locking rod 446a can be turned to set the locking mechanism 446 to a locked or closed state, as shown in Figure 27BAfter the head portion 446a-1 of the locking lever 446a is inserted into the counterbore of the aperture 444, the locking lever 446a can be rotated to set the locking mechanism 446 in a locked state, in which the head rounded side portion 446a-1 protrudes beyond at least a portion of the aperture 444 or beyond the fastener 442, thereby prohibiting the fastener 442 from exiting. The locking mechanism 446 of the present disclosure allows for a quick "one-step" locking, in which the fastener is locked or unlocked by rotating the locking lever 446a only once by a driving tool. The use of a "one-step" locking mechanism can also simplify or reduce the profile of the fixation plate, which is beneficial for inserting and placing the device in the patient anatomy.

[0116] Referring now to Figures 29A-29B The unitary fixation plate 420, 440 of the present disclosure can stabilize and prohibit migration of the intervertebral fusion device 10 in the adjacent vertebrae in any expanded or adjusted configuration. Figure 29A An embodiment is shown in which the example intervertebral fusion device 10 is 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. Figure 29B An embodiment is shown in which the example intervertebral fusion device 10 is in an over-lordotic adjusted configuration with an anterior height of 17.1 mm, a posterior height of 7.2 mm, and a lordosis of 30 degrees. Although the lumbar section of the spine can not require a kyphotic (negative lordotic) adjustment, the intervertebral fusion device 10 can undergo an over-kyphotic adjustment. The lower fixation plate 420 and the upper fixation plate 440 move with the lower shell member 32 and the upper shell member 34 during expansion and / or lordotic adjustment of the intervertebral fusion device 10, thereby allowing for automatic adjustment of the position and / or angle of the apertures in the lower fixation plate 420 and the apertures in the upper fixation plate 440. In Figures 29A-29B In any of the device configurations shown, the fastener trajectory can be further varied at an angle from 0 degrees to 15 degrees, for example, further in a caudal direction or a cephalad direction, thereby allowing for maximum or increased fastener to vertebral body tightening. Figure 26B An embodiment is shown in which the intervertebral fusion device 10 is in a collapsed configuration with an anterior height of 8.4 mm, a posterior height of 8.4 mm, and a lordosis of 0 degrees.

[0117] The dual-axial adjustable intervertebral fusion device 400 with unitary fixation can be used in the treatment of various spinal conditions, including but not limited to degenerative disc disease (DDD), spondylolisthesis, kyphosis (stage 1), etc. Referring to Figure 30In use, the intervertebral fusion device 400 with integral fixation member in the collapsed configuration can be inserted into a patient's anatomy and placed between adjacent vertebrae 72, 74 using a suitable operating instrument 70. Suitable surgical procedures for introducing the intervertebral fusion device 10 into a patient's anatomy include lateral lumbar interbody fusion (LLIF) procedures, anterior lumbar interbody fusion (ALIF) procedures, posterior lumbar interbody fusion (PLIF) procedures, and any other suitable surgical procedure performed in the lumbar or other region of the spine. Various suitable operating instruments are described in U.S. Serial No. 15 / 661,435, filed July 17, 2017, entitled "Surgical Operating Instrument for Expandable and Adjustable Lordosis Interbody Fusion Systems," and U.S. Serial No. 16 / 035,637, filed July 15, 2018, entitled "Surgical Operating Instrument for Expandable and Adjustable Lordosis Interbody Fusion Systems," the disclosures of all of the foregoing U.S. applications are incorporated herein in their entireties. The intervertebral fusion device 10 can be expanded and / or lordosis adjusted using the operating instrument 40 to form a suitable configuration between the adjacent vertebrae 72, 74.

[0118] Fasteners such as bone screws 422, 442 can then be inserted through the apertures in the lower fixation plate 420 and the apertures in the upper fixation plate 420 and driven into the first and second vertebral bodies 72, 74, respectively. Once the fasteners 422, 442 are driven home and the heads of the fasteners are received in the apertures in the fixation plates, the "one-step" locking mechanisms in the lower fixation plate 420 and the upper fixation plate 440 can be actuated using the operating instrument 70 to lock the fasteners 422, 442 to prevent withdrawal of the fasteners 422, 442. The intervertebral fusion device 10 can then be stabilized and prevented from migrating in the vertebral bodies 72, 74, as shown in FIG. 48. Figures 31A-31B

[0119] In conjunction with Figures 26A-31B ​Embodiments of a biaxially adjustable intervertebral fusion device 400 with integral fixation are described. Beneficially, the intervertebral fusion device 400 with integral fixation can stabilize and prevent migration of the intervertebral fusion device in any configuration, including from a smaller expanded configuration to a fully expanded configuration and / or an over- lordotic adjustment configuration, to safely promote fusion between two adjacent vertebral bodies. The intervertebral fusion device of any size and configuration can be integral with the fixation plate of the present disclosure and configured to be inserted via a single surgical procedure and patient position to minimize disruption to the patient anatomy. The integralization of the inferior and superior fixation plates with the intervertebral fusion device allows the fastener apertures to be angled and thus the fastener trajectories to follow the angles of the inferior and superior shell members of the interbody fusion device at angles from 0 degrees to 15 degrees, respectively, to provide ideal fastener trajectories and placement. Other benefits and advantages are the same or similar to those provided by the intervertebral fusion device 100 with modular fixation described above in connection with Figures 2A-11B The benefits and advantages provided by the intervertebral fusion device 100 with modular fixation described are the same or similar and a detailed description thereof is omitted herein.

[0120] According to embodiments of the present disclosure, the first and second drive shafts 24, 26 of the intervertebral fusion device 10 in the apparatus 100 and 400 or in the system 200 and 300 are continuously operable to allow the distance between the inferior and superior shell members 32, 34 at the first lateral region and / or the second lateral region of the shell to be continuously variable, thereby allowing the height of the expanded configuration of the intervertebral fusion device 10 to be continuously variable. By way of example, the height of the intervertebral fusion device 10 can be continuously variable from 0 mm to 10 mm. Additionally or alternatively, the first and second drive shafts 24, 26 of the intervertebral fusion device 10 in the apparatus 100 and 400 or in the system 200 and 300 are continuously operable to allow the angle between the inferior and superior shell members 32, 34 to be continuously variable, thereby allowing the lordosis of the expanded configuration of the intervertebral fusion device 10 to be continuously variable. By way of example, the lordosis of the intervertebral fusion device 10 can be continuously variable from 0 degrees to 30 degrees.

[0121] Unless otherwise defined, the technical and scientific terms used herein have the meanings as commonly understood by one of ordinary skill in the art. As used in the specification and appended claims, the singular forms “a,” “an” and “the” include plural references unless the context clearly dictates otherwise. The term “or” means “and / or” unless the context clearly dictates otherwise. The terms “first” or “second” are used to differentiate one element from another when describing various similar elements and should not be construed as any specific order.

[0122] Those skilled in the art will appreciate that various other modifications are possible. All such or other variations and modifications are intended to be within the scope of the present invention.

Claims

1. A device comprising an interbody fusion apparatus and a fixation assembly, The intervertebral fusion device includes a housing, a first wedge-shaped member, a second wedge-shaped member, a first drive shaft, and a second drive shaft, wherein: The housing includes a first shell member and a second shell member, the first shell member and the second shell member engaging with the first wedge-shaped member along a first lateral region of the housing and engaging with the second wedge-shaped member along a second lateral region of the housing. The first wedge-shaped member is provided with a through opening configured to allow the first drive shaft to pass through, and the second wedge-shaped member is provided with a through opening configured to allow the second drive shaft to pass through. The first drive shaft is operable to drive the first wedge-shaped member along a first lateral region of the housing, and the second drive shaft is operable to drive the second wedge-shaped member along a second lateral region of the housing, causing the first and second housing members to move relative to each other to provide an expanded configuration of the intervertebral fusion device. The fixing assembly includes a first fixing plate having a first hole for inserting a first fastener, wherein... The first fixation plate is modularly configured to be attached to the interbody fusion device, thereby allowing the first fixation plate to be attached in situ to the interbody fusion device in the expanded configuration and fastened to the first vertebral body to stabilize the interbody fusion device and / or prevent the interbody fusion device from migrating.

2. The device according to claim 1, wherein, The fixation assembly further includes a second fixation plate having a second orifice for inserting a second fastener. The second fixation plate is modularly configured to be attached to the interbody fusion device, thereby allowing the second fixation plate to be attached in situ to the interbody fusion device in the expanded configuration and fastened to the second vertebral body to stabilize the interbody fusion device and / or prevent the interbody fusion device from migrating.

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

4. The device according to claim 3, wherein, The first fixation plate is provided with a channel geometry configured to receive the end portion of the second drive shaft of the intervertebral fusion device. The channel geometry extends from a first end to a second end to allow the second drive shaft to be received at a position between the first end and the second end. At the same time, the first fixation plate pivots about the first drive shaft of the intervertebral fusion device, thereby allowing the position of the first orifice in the first fixation plate to be adjusted relative to the first vertebral body.

5. The device according to claim 4, wherein, The channel geometry is configured to allow the first fixation plate to pivot 15 degrees about the first drive axis of the intervertebral fusion device.

6. The device according to claim 4, wherein, The first fixing plate includes an attachment locking mechanism that can be engaged to lock the intervertebral fusion device.

7. The device according to claim 6, wherein, The attachment locking mechanism of the first fixing plate includes: a locking receiving portion; a rod having a first end portion and a second end portion; a compression spring loaded on the rod and held in the locking receiving portion; and a latch connected to the second end portion of the rod, wherein the latch interferes with the first drive shaft of the intervertebral fusion device when the attachment locking mechanism of the first fixing plate is actuated in the locked state.

8. The device according to claim 2, wherein, The second fixation plate includes a protruding portion configured to be inserted into the interbody fusion device. The protruding portion has a geometry configured to be received in a feature portion within the second shell member of the interbody fusion device, thereby limiting unnecessary movement of the interbody fusion device.

9. The device according to claim 8, wherein, The second fixation plate includes an attachment locking mechanism that can be engaged to lock the interbody fusion device.

10. The device according to claim 9, wherein, The attachment locking mechanism of the second fixing plate includes: a locking receiving portion; a rod having a first end portion and a second end portion; a compression spring loaded on the rod and held in the locking receiving portion; and a latch connected to the second end portion of the rod, wherein the latch hooks onto a feature in the second shell member of the intervertebral fusion device when the attachment locking mechanism of the second fixing plate is actuated in the locked state.

11. The device according to claim 2, wherein, The first fixing plate includes a fastener locking mechanism configured to prevent the first fastener from exiting the first orifice in the first fixing plate, and the second fixing plate includes a fastener locking mechanism configured to prevent the second fastener from exiting the second orifice in the second fixing plate.

12. The device according to claim 11, wherein, At least one of the fastener locking mechanism of the first fixed plate and the fastener locking mechanism of the second fixed plate includes a locking member and a compression spring loaded on the locking member, the compression spring having a free state and a compressed state, allowing the locking member to extend beyond the first opening in the first fixed plate or the second opening in the second fixed plate, or to retract from the first opening in the first fixed plate or the second opening in the second fixed plate.

13. The device according to claim 2, wherein, The first fixation plate includes an edge portion with a recessed profile, and the second fixation plate includes an edge portion with a protruding profile, thereby allowing the first fixation plate and the second fixation plate to engage at least partially with each other when attached to the interbody fusion device in a contracted configuration.

14. The device according to claim 2, wherein, The first drive shaft and the second drive shaft can operate independently while driving the first wedge member and the second wedge member to different positions, thereby allowing the degree of expansion of the intervertebral fusion device along the first lateral region of the housing to be independently adjusted relative to the degree of expansion of the intervertebral fusion device along the second lateral region of the housing.

15. The device according to claim 14, wherein, The first wedge-shaped member includes a first pair of screw members, and the second wedge-shaped member includes a second pair of screw members. The first shell member includes a plurality of individual riser members, and the second shell member includes 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 define a first track running section along a first lateral region of the shell, and define a second track running section along a second lateral region of the shell. The first drive shaft is operable to rotate the first pair of screw members to allow the first pair of screw members to travel along the first drive shaft and move on the first track running section, and the second drive shaft is operable to rotate the second pair of screw members to allow the second pair of screw members to travel along the second drive shaft and move on the second track running section.

16. The device according to claim 15, wherein, The first drive shaft and the second drive shaft each include an end portion provided with an external thread and an internal thread, the external thread being configured for connection with an operating instrument, and the internal thread being configured for engagement with a driver in the operating instrument for applying torque.

17. The device according to claim 16, wherein, The first and second fixation plates each include an attachment locking mechanism capable of engaging to lock the interbody fusion device. The attachment locking mechanism includes: a locking receiving portion; a rod having a first end portion and a second end portion; a compression spring loaded on the rod and held in the locking receiving portion; and a latch connected to the second end portion of the rod. The first end portion of the rod has an internal thread substantially the same as the internal threads of the first and second drive shafts, and the locking receiving portion adjacent to the first end portion of the rod has a thread substantially the same as the external threads of the first and second drive shafts. This allows the operating instrument to connect to and drive the first and second drive shafts of the interbody fusion device to connect to the first and second fixation plates respectively and actuate the attachment locking mechanisms of the first and second fixation plates respectively.

18. The device according to claim 17, wherein, The first fixing plate further includes a first fastener locking mechanism configured to prevent the first fastener from exiting the first hole in the first fixing plate, and the second fixing plate further includes a second fastener locking mechanism configured to prevent the second fastener from exiting the second hole in the second fixing plate.

19. The device according to claim 18, wherein, At least one of the fastener locking mechanism of the first fixed plate and the fastener locking mechanism of the second fixed plate includes a locking member and a compression spring loaded on the locking member, the compression spring having a free state and a compressed state, allowing the locking member to extend beyond the first opening in the first fixed plate or the second opening in the second fixed plate, or to retract from the first opening in the first fixed plate or the second opening in the second fixed plate.

20. The device according to claim 15, wherein, The first drive shaft and the second drive shaft are operable to allow the distance between the first shell member and the second shell member at the first lateral region of the shell and / or at the second lateral region of the shell to be continuously varied, thereby allowing the height of the expansion configuration of the intervertebral fusion device to be continuously varied.

21. The device according to claim 15, wherein, The first drive shaft and the second drive shaft can be operated continuously to allow the angle between the first shell member and the second shell member to change continuously, thereby allowing the anterior or posterior convexity of the expansion configuration of the intervertebral fusion device to change continuously.

22. A spinal system comprising an interbody fusion device and a fixation assembly. The intervertebral fusion device includes a housing, a first wedge-shaped member, a second wedge-shaped member, a first drive shaft, and a second drive shaft, wherein: The housing includes a first shell member and a second shell member, the first shell member and the second shell member engaging with the first wedge-shaped member along a first lateral region of the housing and engaging with the second wedge-shaped member along a second lateral region of the housing. The first wedge-shaped member is provided with a through opening configured to allow the first drive shaft to pass through, and the second wedge-shaped member is provided with a through opening configured to allow the second drive shaft to pass through. The first drive shaft is operable to drive the first wedge-shaped member along a first lateral region of the housing, and the second drive shaft is operable to drive the second wedge-shaped member along a second lateral region of the housing, causing the first and second housing members to move relative to each other to provide an expanded configuration of the intervertebral fusion device. The fixing assembly includes a single fixing plate, a first fastener, and a second fastener, wherein... The single fixation plate is configured to be attached to the intervertebral fusion device in the expanded configuration and is provided with a first orifice and a second orifice. The first orifice is for a first fastener to pass through and be inserted into the first vertebral body, and the second orifice is for a second fastener to pass through and be inserted into the second vertebral body. This allows the single fixation plate to be attached to the intervertebral fusion device in situ and fixed to the first and second vertebral bodies to stabilize the intervertebral fusion device and / or prevent the intervertebral fusion device from migrating.

23. The system according to claim 22, wherein, The single fixation plate is constructed of a material with strength capable of providing supplemental fixation to the first and second vertebrae.

24. The system according to claim 22, wherein, The single fixation plate includes a first male geometry and a second male geometry. The first drive shaft of the intervertebral fusion device includes an end portion having a first female geometry, and the second drive shaft of the intervertebral fusion device includes 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 intervertebral fusion device are configured to have complementary mating features, and the second male geometry of the single fixation plate and the second female geometry of the second drive shaft of the intervertebral fusion device are configured to have complementary mating features. Thus, when the single fixation plate is attached to the intervertebral fusion device, the first male geometry and the second male geometry of the single fixation plate engage with the first female geometry and the second female geometry in the end portions of the first drive shaft and the second drive shaft of the intervertebral fusion device, respectively, thereby limiting unnecessary rotation of the first drive shaft and the second drive shaft.

25. The system according to claim 24, wherein, At least one of the first anode geometry and the second anode geometry of the single fixed plate includes a hexagonal geometry.

26. The system according to claim 22, wherein, The single fixation plate includes a protrusion configured to be inserted into the interbody fusion device, the protrusion having a geometry configured to mate with components in the interbody fusion device, thereby limiting unnecessary movement of the interbody fusion device.

27. The system according to claim 26, wherein, The protruding portion has a non-circular prism shape.

28. The system according to claim 26, wherein, The individual fixation plate also includes an attachment locking mechanism that can be engaged to lock the interbody fusion device.

29. The system according to claim 28, wherein, The attachment locking mechanism includes: a locking receiving portion located in a protruding portion of the single fixing plate; a rod having a first end portion and a second end portion; a compression spring loaded on the rod and held in the locking receiving portion; and a latch coupled to the second end portion of the rod, the latch being operable to rotate and hook onto a component in the intervertebral fusion device.

30. The system according to claim 22, wherein, The single fixing plate further includes: a first fastener locking mechanism and a second fastener locking mechanism, the first fastener locking mechanism being configured to prevent the first fastener from exiting from the first opening, and the second fastener locking mechanism being configured to prevent the second fastener from exiting from the second opening.

31. The system according to claim 30, wherein, At least one of the first fastener locking mechanism and the second fastener locking mechanism includes a locking member and a compression spring loaded on the locking member, the compression spring having a free state and a compressed state, the free state allowing the locking member to extend beyond the first orifice or the second orifice, and the compressed state allowing the locking member to be forced away from the first orifice or the second orifice.

32. The system according to claim 22, wherein, The first drive shaft and the second drive shaft can be operated independently to drive the first wedge member and the second wedge member to different positions individually, thereby allowing the degree of expansion of the intervertebral fusion device along the first lateral region of the housing to be independently adjusted relative to the degree of expansion of the intervertebral fusion device along the second lateral region of the housing.

33. The system according to claim 32, wherein The first wedge-shaped member includes a first pair of screw members, and the second wedge-shaped member includes a second pair of screw members. The first shell member includes a plurality of individual riser members, and the second shell member includes 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 define a first track running section along a first lateral region of the shell, and define a second track running section along a second lateral region of the shell. The first drive shaft is operable to rotate the first pair of screw members to allow the first pair of screw members to travel along the first drive shaft and move on the first track running section, and the second drive shaft is operable to rotate the second pair of screw members to allow the second pair of screw members to travel along the second drive shaft and move on the second track running section.

34. The system according to claim 33, wherein, The first drive shaft and the second drive shaft each include an end portion provided with an external thread and an internal thread, the external thread being configured for connection with an operating instrument, and the internal thread being configured for engagement with a driver in the operating instrument for applying torque.

35. The system according to claim 34, wherein, The single fixation plate includes an attachment locking mechanism that can be engaged by the manipulator to lock the interbody fusion device. The attachment locking mechanism includes: a locking receiving portion; a rod having a first end portion and a second end portion; a compression spring loaded on the rod and held in the locking receiving portion; and a latch connected to the second end portion of the rod. The first end portion of the rod has an internal thread substantially the same as the internal threads of the first and second drive shafts, and the locking receiving portion adjacent to the first end portion of the rod has a thread substantially the same as the external threads of the first and second drive shafts. This allows the manipulator to connect to and drive the first and second drive shafts of the interbody fusion device to engage with and actuate the attachment locking mechanism of the single fixation plate.

36. The system according to claim 35, wherein, The single fixing plate further includes a first fastener locking mechanism and a second fastener locking mechanism, the first fastener locking mechanism being configured to prevent the first fastener from exiting from the first orifice, and the second fastener locking mechanism being configured to prevent the second fastener from exiting from the second orifice.

37. The system according to claim 36, wherein, At least one of the first fastener locking mechanism and the second fastener locking mechanism includes a locking member and a compression spring loaded on the locking member, the compression spring having a free state and a compressed state, the free state allowing the locking member to extend beyond the first orifice or the second orifice, and the compressed state allowing the locking member to be forced away from the first orifice or the second orifice.

38. The system according to claim 34, wherein, The first drive shaft and the second drive shaft can be operated continuously to allow the angle between the first shell member and the second shell member to change continuously, thereby allowing the anterior convexity of the expansion configuration of the intervertebral fusion device to change continuously.

39. The system according to claim 38, wherein, The angle between the first shell member and the second shell member can be continuously varied from 0 degrees to 30 degrees.

40. The system according to claim 34, wherein, The first drive shaft and the second drive shaft are operable to allow the distance between the first shell member and the second shell member at the first lateral region of the shell and / or at the second lateral region of the shell to be continuously varied, thereby allowing the height of the expansion configuration of the intervertebral fusion device to be continuously varied.

41. The system according to claim 40, wherein, The height of the expanded configuration of the intervertebral fusion device can be continuously varied from 0 mm to 9 mm.

42. A spinal system comprising an interbody fusion device and a fixation assembly. The intervertebral fusion device includes a housing, a first wedge-shaped member, a second wedge-shaped member, a first drive shaft, and a second drive shaft, wherein: The housing includes a first shell member and a second shell member, the first shell member and the second shell member engaging with the first wedge-shaped member along a first lateral region of the housing and engaging with the second wedge-shaped member along a second lateral region of the housing. The first wedge-shaped member is provided with a through opening configured to allow the first drive shaft to pass through, and the second wedge-shaped member is provided with a through opening configured to allow the second drive shaft to pass through. The first drive shaft is operable to drive the first wedge-shaped member along a first lateral region of the housing, and the second drive shaft is operable to drive the second wedge-shaped member along a second lateral region of the housing, causing the first and second housing members to move relative to each other to provide an expanded configuration of the intervertebral fusion device. The fixing assembly includes a single fixing plate, a first fastener, and a second fastener. The single fixing plate is provided with a first opening and a second opening. The first opening is used to allow the first fastener to pass through and be inserted into a first vertebral body, and the second opening is used to allow the second fastener to pass through and be inserted into a second vertebral body. The single fixation plate is capable of being inserted into the intervertebral fusion device in situ and is rotatable relative to the intervertebral fusion device, thereby allowing the positions of the first and second orifices in the single fixation plate to be adjusted in situ. The single fixation plate is configured to provide supplemental fixation for the first and second vertebral bodies.

43. The system according to claim 42, wherein, The single fixation plate is capable of rotating clockwise and / or counterclockwise at an angle from 0 to 11 degrees relative to an imaginary plane including the first and second drive shafts of the intervertebral fusion device, thereby allowing the positions of the first and second orifices in the single fixation plate to be adjusted in situ at an angle from 0 to 11 degrees clockwise and / or counterclockwise.

44. The system according to claim 43, wherein, The single fixation plate includes a protruding portion configured to be inserted into the expanded configuration of the interbody fusion device.

45. The system according to claim 44, wherein, The single fixation plate can be attached to the interbody fusion device via a protruding portion of the single fixation plate.

46. ​​The system according to claim 45, wherein, The protruding portion has a semi-cylindrical geometric structure.

47. The system according to claim 45, wherein, The individual fixation plate also includes an attachment locking mechanism that can be engaged to lock the interbody fusion device to the individual fixation plate.

48. The system according to claim 47, wherein, The attachment locking mechanism includes: a locking receiving portion located in a protruding portion of the single fixing plate; a rod having a first end portion and a second end portion; a compression spring loaded on the rod and held in the locking receiving portion; and a latch coupled to the second end portion of the rod, the latch being operable to rotate and hook onto a component of the intervertebral fusion device.

49. The system according to claim 42, wherein, The single fixing plate further includes: a first fastener locking mechanism and a second fastener locking mechanism, the first fastener locking mechanism being configured to prevent the first fastener from exiting from the first opening, and the second fastener locking mechanism being configured to prevent the second fastener from exiting from the second opening.

50. The system according to claim 49, wherein, At least one of the first fastener locking mechanism and the second fastener locking mechanism includes a locking member and a compression spring loaded on the locking member, the compression spring having a free state and a compressed state, the free state allowing the locking member to extend beyond the first orifice or the second orifice, and the compressed state allowing the locking member to be forced away from the first orifice or the second orifice.

51. The system according to claim 42, wherein, The first drive shaft and the second drive shaft can be operated independently to drive the first wedge member and the second wedge member to different positions individually, thereby allowing the degree of expansion of the intervertebral fusion device along the first lateral region of the housing to be independently adjusted relative to the degree of expansion of the intervertebral fusion device along the second lateral region of the housing.

52. The system according to claim 51, wherein, The first wedge-shaped member includes a first pair of screw members, and the second wedge-shaped member includes a second pair of screw members. The first shell member includes a plurality of individual riser members, and the second shell member includes 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 define a first track running section along a first lateral region of the shell, and define a second track running section along a second lateral region of the shell. The first drive shaft is operable to rotate the first pair of screw members to allow the first pair of screw members to travel along the first drive shaft and move on the first track running section, and the second drive shaft is operable to rotate the second pair of screw members to allow the second pair of screw members to travel along the second drive shaft and move on the second track running section.

53. The system according to claim 52, wherein, The first drive shaft and the second drive shaft each include an end portion provided with an external thread and an internal thread, the external thread being configured for connection with an operating instrument, and the internal thread being configured for engagement with a driver in the operating instrument for applying torque.

54. The system according to claim 53, wherein, The single fixation plate includes an attachment locking mechanism that can be engaged by the manipulator to lock the interbody fusion device. The attachment locking mechanism includes: a locking receiving portion; a rod having a first end portion and a second end portion; a compression spring loaded on the rod and held in the locking receiving portion; and a latch connected to the second end portion of the rod. The first end portion of the rod has an internal thread substantially the same as the internal threads of the first and second drive shafts, and the locking receiving portion adjacent to the first end portion of the rod has a thread substantially the same as the external threads of the first and second drive shafts. This allows the manipulator to connect to and drive the first and second drive shafts of the interbody fusion device to engage with and actuate the attachment locking mechanism of the single fixation plate.

55. The system according to claim 54, wherein, The single fixing plate further includes a first fastener locking mechanism and a second fastener locking mechanism, the first fastener locking mechanism being configured to prevent the first fastener from exiting from the first orifice, and the second fastener locking mechanism being configured to prevent the second fastener from exiting from the second orifice.

56. The system according to claim 55, wherein, At least one of the first fastener locking mechanism and the second fastener locking mechanism includes a locking member and a compression spring loaded on the locking member, the compression spring having a free state and a compressed state, the free state allowing the locking member to extend beyond the first orifice or the second orifice, and the compressed state allowing the locking member to be forced away from the first orifice or the second orifice.

57. The system according to claim 53, wherein, The first drive shaft and the second drive shaft are operable to allow the distance between the first shell member and the second shell member at the first lateral region of the shell and / or at the second lateral region of the shell to be continuously varied, thereby allowing the height of the expansion configuration of the intervertebral fusion device to be continuously varied.

58. The system according to claim 57, wherein, The height of the expanded configuration of the intervertebral fusion device can be continuously varied from 0 mm to 9 mm.

59. The system according to claim 53, wherein, The first drive shaft and the second drive shaft can be operated continuously to allow the angle between the first shell member and the second shell member to change continuously, thereby allowing the anterior convexity of the expansion configuration of the intervertebral fusion device to change continuously.

60. The system according to claim 59, wherein, The angle between the first shell member and the second shell member can be continuously varied from 0 degrees to 30 degrees.

61. A device comprising an interbody fusion apparatus and a fixation assembly, The intervertebral fusion device includes a housing, a first wedge-shaped member, a second wedge-shaped member, a first drive shaft, and a second drive shaft, wherein: The housing includes a first shell member and a second shell member, the first shell member and the second shell member engaging with the first wedge-shaped member along a first lateral region of the housing and engaging with the second wedge-shaped member along a second lateral region of the housing. The first wedge-shaped member is provided with a through opening configured to allow the first drive shaft to pass through, and the second wedge-shaped member is provided with a through opening configured to allow the second drive shaft to pass through. The first drive shaft is operable to drive the first wedge-shaped member along a first lateral region of the housing, and the second drive shaft is operable to drive the second wedge-shaped member along a second lateral region of the housing, causing the first and second housing members to move relative to each other to provide an expanded configuration. The first and second drive shafts are independently operable to drive the first and second wedge-shaped members to different positions, thereby causing the interbody fusion device to expand along the first lateral region of the housing to a different extent than the extent of expansion along the second lateral region of the housing. The fixing assembly includes: a first fixing plate and a second fixing plate, wherein the first fixing plate has a first hole for inserting a first fastener, and the second fixing plate has a second hole for inserting a second fastener. The first fixation plate is connected to the first shell member, and the second fixation plate is connected to the second shell member, thereby allowing the first and second fixation plates to be implanted together with the intervertebral fusion device, to be angled in situ by movement of the first and / or second shell members, and to be fastened to the adjacent vertebral body to stabilize the intervertebral fusion device and / or prevent the intervertebral fusion device from migrating.

62. The device according to claim 61, wherein, The first fixing plate is integrally formed with the first shell member, and / or the second fixing plate is integrally formed with the second shell member.

63. The device according to claim 61, wherein, The first fixing plate is a separate piece and is connected to the first shell member by an interference fit or a threaded connection, and / or the second fixing plate is a separate piece and is connected to the second shell member by an interference fit or a threaded connection.

64. The device according to claim 61, wherein, The first opening is adjacent to the periphery of the first fixing plate to reduce the outline of the first fixing plate, and / or the second opening is adjacent to the periphery of the second fixing plate to reduce the outline of the second fixing plate.

65. The device according to claim 61, wherein, The first opening in the first fixing plate is configured to allow the trajectory of the first fastener to be adjusted from an angle of 0 to 15 degrees, and / or the second opening in the second fixing plate is configured to allow the trajectory of the second fastener to be adjusted from an angle of 0 to 15 degrees.

66. The device according to claim 61, wherein, The first fixing plate includes a first fastener locking mechanism configured to prevent the first fastener from exiting from the first orifice in the first fixing plate, and the second fixing plate includes a second fastener locking mechanism configured to prevent the second fastener from exiting from the second orifice in the second fixing plate.

67. The device according to claim 66, wherein, The first fastener locking mechanism includes a locking lever with a head having a rounded side portion and a flat side portion. The locking lever is rotatable to allow the rounded side portion to extend beyond the first orifice to provide a locked state of the first fastener locking mechanism, or to allow the flat side portion to face the first orifice to provide an unlocked state of the first fastener locking mechanism.

68. The device according to claim 67, wherein, The second fastener locking mechanism includes the same locking lever as the first fastener locking mechanism.

69. The device according to claim 61, wherein, The first drive shaft and the second drive shaft can be operated independently to drive the first wedge member and the second wedge member to different positions individually, thereby allowing the degree of expansion of the intervertebral fusion device along the first lateral region of the housing to be independently adjusted relative to the degree of expansion of the intervertebral fusion device along the second lateral region of the housing.

70. The device according to claim 69, wherein The first wedge-shaped member includes a first pair of screw members, and the second wedge-shaped member includes a second pair of screw members. The first shell member includes a plurality of individual riser members, and the second shell member includes 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 define a first track running section along a first lateral region of the shell, and define a second track running section along a second lateral region of the shell. The first drive shaft is operable to rotate the first pair of screw members to allow the first pair of screw members to travel along the first drive shaft and move on the first track running section, and the second drive shaft is operable to rotate the second pair of screw members to allow the second pair of screw members to travel along the second drive shaft and move on the second track running section.

71. The device according to claim 70, wherein, The first drive shaft and the second drive shaft are operable to allow the distance between the first shell member and the second shell member at the first lateral region and / or the second lateral region of the shell to be continuously varied, thereby allowing the height of the expansion configuration of the intervertebral fusion device to be continuously varied.

72. The device according to claim 71, wherein, The height of the expanded configuration of the intervertebral fusion device can be continuously varied from 0 mm to 9 mm.

73. The device according to claim 71, wherein, The first fixing plate is integrally formed with the first shell member, and / or the second fixing plate is integrally formed with the second shell member.

74. The device according to claim 73, wherein, The first fixing plate includes a first fastener locking mechanism configured to prevent the first fastener from exiting the first orifice, and / or the second fixing plate includes a second fastener locking mechanism configured to prevent the second fastener from exiting the second orifice.

75. The device according to claim 71, wherein, The first drive shaft and the second drive shaft can be operated continuously to allow the angle between the first shell member and the second shell member to change continuously, thereby allowing the anterior convexity of the expansion configuration of the intervertebral fusion device to change continuously.

76. The device according to claim 75, wherein, The angle between the first shell member and the second shell member can be continuously varied from 0 degrees to 30 degrees.

77. The device according to claim 75, wherein, The first fixing plate is integrally formed with the first shell member, and / or the second fixing plate is integrally formed with the second shell member.

78. The device according to claim 77, wherein, The first fixing plate includes a first fastener locking mechanism configured to prevent the first fastener from exiting the first orifice, and / or the second fixing plate includes a second fastener locking mechanism configured to prevent the second fastener from exiting the second orifice.

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