Total joint replacement for offset vertebrae
The total joint replacement spinal implant addresses the limitations of current fusion and stabilization devices by replacing both the disc and facets, optimizing spinal alignment and balance, and maintaining spinal integrity through motion preservation and load sharing, thereby enhancing patient outcomes.
Patent Information
- Application Number
- PCT/US2025/031080
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-05-30
- Filing Date
- 2025-05-27
- Publication Date
- 2025-12-04
AI Technical Summary
Current spinal fusion and dynamic stabilization devices fail to effectively address severe spinal deformities, maintain sagittal or coronal alignment, and preserve spinal integrity, leading to issues like increased wear debris, improper alignment, and adjacent segment disease.
A total joint replacement spinal implant system that functions as a dynamic spinal implant, replacing both the intervertebral disc and facets, restoring biomechanical function, and optimizing spinal curvature and balance by maintaining the anatomical center of rotation in the sagittal plane, while allowing for motion preservation and load sharing.
The system effectively restores spinal mobility and stability, reduces wear debris, and prevents adjacent segment disease by reconstructing a functional spine unit, providing sagittal balance during daily activities.
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Figure US2025031080_04122025_PF_FP_ABST
Abstract
Description
TOTAL JOINT REPLACEMENT FOR OFFSET VERTEBRAE
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 653,841 entitled “TOTAL JOINT REPLACEMENT FOR OFFSET VERTEBRAE” filed May 30, 2024, the disclosure of which is incorporated by reference herein in its entirety.
[0003] TECHNICAL FIELD
[0004] The improved intervertebral spinal implant system generally relates to a spinal implant system for insertion into an intervertebral space between adjacent vertebrae of a human spine, to provide and / or restore range of motion, stability, flexibility, coronal alignment / balance, sagittal alignment / balance and proper biomechanical motion. More specifically, the improved intervertebral spinal implant system may include system particularized for use with treatment of vertebral levels having offset vertebral bodies, such as in cases of spondylolisthesis, scoliosis, lateral listhesis and / or retrolisthesis.
[0005] BACKGROUND OF THE INVENTION
[0006] At times, the source of a patient's back pain may not be clear. Among possible causes for such pain are disease, degradation and / or injury to the vertebra and / or discs of the spine, as well as to various ancillary structures such as the lamina and / or associated facet joints. While spinal fusion and / or disc arthroplasty procedures have been successful in treating spinal joints to reduce pain, such treatments are often limited in their efficacy. Such fusion surgeries often fuse or immobilize portions or a patient’s spine and are often unable to address and / or correct severe spinal deformities, return or restore patients sagittal or coronal alignment, as well as maintain columnar stability without affecting adjacent vertebral segments.
[0007] However, in the past decade, there has been an emerging option of dynamic stabilization as an alternative to fusion. Dynamic stabilization was designed to ameliorate the instability while maintaining segmental motility, thus reducing or eliminating the potential for adjacent segment disease. Unfortunately, the current interbody dynamic stabilization devices have many disadvantages, including: (1) increased wear debris that initiates inflammatory responses; (2) does not preserve, support or stabilize the posterior bony spinal elements (e.g., facets); (3) increased improper placements or less than ideal position, which can affect the expected range of motion and cause an increase of load to the facets; (4) improper alignment of the spine, including but not limited to undesired increased segmental lordosis; (5) increased migration; (6) requires preservation of endplate; and (7) must come equipped with various degrees of angulation to accommodate an individual’s lumbar lordosis.
[0008] BRIEF SUMMARY OF THE INVENTION
[0009] Therefore, an improved motion preserving spinal implant system and / or an intervertebral spinal implant system is needed to function as a total spinal joint replacement or total joint replacement rather than just a dynamic stabilization device. The spinal implant system functions as a total joint replacement because it replaces at least two structures in the spine - the intervertebral disc and facets - in a single medical procedure, while restoring or optimizing freedom of movement (e.g., the dynamic or motion feature of the spinal implant). Furthermore, the spinal implant may further restore or optimize the biomechanics of one or more spinal segments, redistribute loads throughout the vertebral bodies (e.g., improve load sharing characteristics or features) to facilitate stabilization and / or support, and restore or optimize spinal curvature and balance via adjusting the sagittal and / or coronal orientation. In addition, where a significant spinal offset exists in a spinal region proposed for treatment, such as in a spondylolisthesis or retrolisthesis, spinal motion implants particularized for use with a spinal offset are described herein, which may further optimize surgical outcomes and patient satisfaction. In essence, the disclosed devices and procedures allow for reconstructing a functional spine unit (FSU) by maintaining the anatomical center of rotation in the sagittal plane, which facilitates restabilization of the FSU after bony decompression while concurrently providing sagittal balance during flexion and extension range of motion encountered during activities of daily living.
[0010] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0011] FIGS. 1A-1B depict a sagittal view of one embodiment of one or more spinal functional units or segments;
[0012] FIGS. 2A-2C depict various anatomical views of one embodiment of a vertebral body;
[0013] FIG. 3A depicts a sagittal view of a various spine segments with different types of degenerated discs;
[0014] FIG. 3B depict an anterior and sagittal view of one embodiment of a scoliotic and lordotic spine;
[0015] FIG. 4A depicts a sagittal view of a portion of a spine with natural lordotic spine orientations in multiple spinal segments;
[0016] FIG. 4B depicts a posterior view of multiple spinal segments within the lumbar region illustrating the natural transverse pedicle angles on right and left sides;
[0017] FIGS. 4C-4D illustrates tables with various pedicle morphological measurements in different spine regions;
[0018] FIGS. 5A-5C depicts multiple anatomical views of a vertebral body within the lumbar region illustrating the natural transverse pedicle angles and other anatomical dimensions;
[0019] FIGS. 6A-6B depicts a sagittal and superior view of one or more vertebral segments highlighting the three supporting columns;
[0020] FIGS. 7A-7H depicts various plan views of one embodiment of a spinal implant;
[0021] FIGS. 8A-8D depicts various plan views of an alternate embodiment of a spinal implant;
[0022] FIG. 9A depicts an exploded isometric view of one embodiment of the spinal implant of FIGS. 7A-7H;
[0023] FIG. 9B depicts an exploded isometric view of the alternate embodiment of the spinal implant of FIGS. 8A-8D;
[0024] FIGS. 10A-10F depicts various plan views of one embodiment of a superior element of the dynamic spinal implant of FIGS. 7A-7H;
[0025] FIG. 10G depicts a side cross-sectional view of the superior element of FIGS. 10A-10F;
[0026] FIGS. 10H-10M depicts various plan views of an alternate embodiment of a superior element of the spinal implant of FIGS. 8A-8D;
[0027] FIG. 10N depicts a side cross-sectional view of the superior element of FIGS. 10H-10M;
[0028] FIGS. 11A-11 E depicts a side view of the superior element of FIGS. 10H-1 ON in different heights;
[0029] FIGS. 12A-12C depicts a side view of the superior element of FIGS. 10H-10N in different lengths;
[0030] FIGS. 13A-13G depict various plan views of one embodiment of a base of the superior element of FIGS. 10A-10F;
[0031] FIGS. 14A-14I depict various plan views of an alternate embodiment of a base of the superior element of FIGS. 10H-10M;
[0032] FIGS. 15A-15G depict various plan views of one embodiment of a superior articulating component;
[0033] FIGS. 15H-15N depict various plan views of an alternate embodiment of a superior articulating component;
[0034] FIGS. 16A-16H depict various plan views of one embodiment of an inferior element of the spinal implant of FIGS. 7A-7H;
[0035] FIGS. 17A-17F depict various plan views of an alternate embodiment of an inferior element of the spinal implant of FIGS. 8A-8D;
[0036] FIGS. 18A-18C depict top and side views of an inferior element of FIGS. 17A-17F in different lengths;
[0037] FIGS. 19A-19E depicts various plan views of one embodiment of a fixation screw;
[0038] FIGS. 20A-20E depicts various plan views of an alternate embodiment of a fixation screw;
[0039] FIGS. 21A-21 D depicts various plan views of one embodiment of a retention clip;
[0040] FIGS. 21 E-21G depicts various plan views of an alternate embodiment of a retention clip;
[0041] FIGS. 22A-22B depicts a side view of a spinal implant having flexion and extension motion;
[0042] FIGS. 23A-23B depicts a top view of a spinal implant having right to left axial rotation;
[0043] FIG. 24A depicts a sagittal cross-sectional view of a spinal implant disposed between at least one spinal segment or level;
[0044] FIG. 24B depicts a sagittal cross-sectional view of a spinal implant disposed between at multiple spinal segment or levels;
[0045] FIG. 25 depicts a side view of the different heights and widths of a spinal implant;
[0046] FIGS. 26A-26D depicts a top or superior views of a spinal implant disposed onto a vertebral body in various toe-in orientations;
[0047] FIG. 27 depicts a top or superior view of a spinal implant disposed onto and supporting the three columns of a vertebral body;
[0048] FIGS. 28A-28B illustrates a sagittal view of a spinal implant disposed between an upper and lower vertebral body in a parallel plane to the endplate;
[0049] FIGS. 29A-29D illustrates a sagittal view and cross-sectional view of one embodiment of the parallel orientation angles or orientation planes cut into the vertebral body;
[0050] FIGS. 30A-30D illustrates a sagittal view and cross-sectional view of one embodiment of the non-parallel orientation angles or orientation planes in the sagittal view cut into the vertebral body to create additional lordosis for correcting sagittal imbalance;
[0051] FIG. 31 depicts a side view or sagittal view of the spinal implant in different non-parallel sagittal orientation planes;
[0052] FIGS. 32A-32D depicts a coronal views and sagittal cross-sectional view of one embodiment of the non-parallel orientation angles or orientation planes in the coronal view cut into the vertebral body to create additional scoliosis for correcting coronal imbalance;
[0053] FIGS. 33A-33B depicts a side view of the spinal implant of FIGS. 34A-34G disposed between at least one spinal segment;
[0054] FIGS. 34A-34G depicts various plan views of an alternate embodiment of a spinal implant;
[0055] FIG. 35 depicts an isometric exploded view of the spinal implant of FIGS. 34A-34G;
[0056] FIGS. 36A-36G depicts various plan views of an alternate embodiment of a superior element of the spinal implant of FIGS. 34A-34G;
[0057] FIG. 36H depicts a cross-sectional view of the superior element of FIGS. 36A-36G;
[0058] FIG. 37 depicts an isometric exploded view of the superior element of FIGS. 36A-36G;
[0059] FIGS. 38A-38E depict various plan views of an alternate embodiment of a base of the superior element of FIGS. 36A-36G;
[0060] FIGS. 39A-39F depict various plan views of an alternate embodiment of an articulation component of FIGS. 36A-36G;
[0061] FIGS. 40A-40F depict various plan views of an alternate embodiment of an inferior element of FIGS. 36A-36G;
[0062] FIG. 40G depicts a cross-sectional side view of the inferior element of FIGS. 40A-40F;
[0063] FIGS. 41 A and 41 B depict views of another exemplary embodiment of a lower or inferior element;
[0064] FIG. 42 depicts a side view of the inferior element of FIGS 41 A and 41 B with a corresponding superior element;
[0065] FIGS. 43A through 43E depict various views of one exemplary embodiment of an inferior buttress plate;
[0066] FIG. 44 depicts an exploded view of the buttress plate of FIGS. 43A through 43E with various associated implant components; and
[0067] FIG. 45 depicts the buttress plate of FIGS. 43A through 43E assembled with the associated implant components of FIG. 44.
[0068] DETAILED DESCRIPTION OF THE INVENTION
[0069] The human spine is a complex mechanical structure including alternating bony vertebrae and fibrocartilaginous discs that are connected by strong ligaments and supported by musculature that extends from the skull to the pelvis and provides axial support to the body. Accordingly, the human spine is a highly flexible structure capable of a high degree of curvature and twist in nearly every direction, such as flexion and extension in sagittal plane, left lateral flexion and right lateral flexion in the frontal plane and left and right rotation in transverse plane. However, genetic or developmental irregularities, trauma, chronic stress, and degenerative wear can result in spinal pathologies for which surgical intervention may be necessary.
[0070] Due to the many disadvantages of fusion surgery, there is a need for a more effective and versatile total joint replacement spinal implant system that functions as a successful alternative to fusion rather than the standard available dynamic stabilization devices. The disclosed total joint replacement systems described herein are improved dynamic or motionpreserving spinal implants that can restore biomechanical function, restore spino-pelvic balance, and stabilize the spine without the loss of spinal integrity and mobility. Surgical correction of the spino-pelvic balance is needed to lead a better quality of life for patients.
[0071] The total joint replacement system is a dynamic spinal implant which replaces the function of the disc and the facet joints by comprising a unique design with motion preservation and load sharing features that allow the implant to extend within two or more columns and / or all three columns of the spine. Furthermore, the total joint replacement system can accomplish the above by using one design in different sizes and without requiring the availability of different designs with degrees of lordotic angulations for lordotic correction. This is counterintuitive to the traditional spinal implants - traditional spinal implants typically require different sized and / or shaped designs with varying degrees of lordotic angulations to help align or optimize the spinal curvatures of a patient.
[0072] The total joint replacement systems disclosed herein allow for reconstructing a functional spine unit (FSU) by maintaining the anatomical center of rotation in the sagittal plane, which facilitates restabilization of the FSU after bony decompression while concurrently providing sagittal balance during flexion and extension range of motion encountered during activities of daily living. The total joint replacement system may be used or designed for the treatment of various degenerative disc diseases in the vertebral column, such as the cervical, thoracic and lumbar regions. Such degenerative disc diseases include, but not limited to lordosis, kyphosis, scoliosis, lateral listhesis, spondylolisthesis, and / or any other misalignment of the vertebral column regions.
[0073] This specification describes novel systems and devices to treat spinal degenerative diseases. Aspects of the present invention will be described regarding the treatment of vertebral bodies at the different levels of the spine, including cervical, thoracic and lumbar levels. It should be appreciated, however, that various aspects of the invention may not limited in their application to spinal injuries and / or degeneration. The systems and methods may be applicable to the treatment of degeneration in diverse bone types or bone joints, as well as in other anatomical locations, including the elbow, neck, knee, shoulder, and / or hip. However, to understand unique features of the improved dynamic spinal implant, further explanation of the spinal morphology is necessary.
[0074] Spinal Morphology
[0075] Referring to FIG. 1A, a sagittal view of a healthy vertebral column 5 is shown, illustrating a sequence of vertebrae V1 , V2, V3, V4 separated by natural intervertebral discs D1, D2, D3, respectively. Although the illustration generally depicts a lumbar section of a spinal column, it isunderstood that the devices, systems, and methods of this disclosure may also be applied to all regions of the vertebral column, including thoracic and cervical regions.
[0076] Referring to FIG. 1 B, in any given vertebral joint, functional spinal unit or spinal segment 10 of the vertebral column 5 includes the adjacent vertebrae V3, V4 which the intervertebral disc D3 is disposed in between. More specifically, the top vertebra V3 may be referred to as the superior vertebra or the upper vertebra and the bottom vertebra V4 may be referred to as the inferior vertebra or the lower vertebra. The top vertebra V3 includes a generally cylindrical vertebral body portion 12, an inferior articular process 14, and an inferior facing endplate 16. The vertebra V4 includes a generally cylindrical vertebral body portion 18 (which is a weight bearing area), a superior articular process 20, and a superior facing endplate 24. For reference purposes, a longitudinal axis 26 extends through the centers of the cylindrical vertebral body portions 12, 18. A pedicle 24 extends between the inferior vertebral body 18 and superior articular process 20.
[0077] FIGS. 2A-2C depict different views of a portion of a vertebra V3, V4. On the vertebra V3, V4 there are seven processes projecting from the vertebra body portion 12,18. There is one spinous process 36, two transverse processes 32, four articular processes 14, 20 and a spinal canal 34. The two transverse processes 32, one on each side of the vertebral body portion 12, 18 project laterally from either side at the point where the lamina 28 joins the pedicle 24, between the superior 20 and inferior 14 articular processes. The lamina 28 covers the spinal canal, which is the large hole in the center of the vertebra that the spinal nerves pass. The spinous process 36 extends from the lamina 28 and projects centrally. The spinous process 36 serves to attach muscles and ligaments. The inferior articular process 14 and the superior articular process 20 form a facet or zygapophyseal joint 22. The facet joint 22 has a fluid filled capsule and cartilage to provide articulating surfaces for the articular processes 16, 20 and help restrict the range of motion.
[0078] Both the disc D1 and the facet joint 26 permit motion between adjacent bone surfaces, allowing the total vertebral joint, functional spinal unit or spinal segment 10 to comprise translational motion, the translational motion includes a normal range of flexion / extension, lateral bending, and axial or transverse rotational motion. As the disc D1 and / or the facet joint 26 deteriorate due to aging, injury, disease, or other factors, all or portions of the disc, the facet joint, and / or the articular processes 16, 22 leading to disc and / or facet degeneration. FIG. 3A depicts a spinal column with different types of degenerated discs 38 that may lead to changes of certain properties of the normal disc 11 , including a degenerated disc 13, a bulging disc 15, herniated discs 17, thinning discs 19, or contain osteophytes 21. Such degeneration canadversely affect the structural integrity of the spine and contribute to scoliosis 40, kyphosis 42 and / or lordosis 43 as shown in FIG. 3B. Scoliosis, lordosis and kyphosis 40, 42, 43 are curves that are exaggerated or abnormal to the spine’s natural curvatures (e.g., natural lordotic or kyphotic curves) leading to pain, deformity and / or neurologic dysfunction. More specifically, scoliosis is abnormal or exaggerated curvature in the coronal plane, and lordosis is abnormal or exaggerated curvature in the sagittal plane. Any exaggeration or abnormalities of the curves in the sagittal plane or coronal plane, results in sagittal imbalance or coronal imbalance. If the degeneration and / or curve abnormalities significantly or severely affect the patient, a surgeon may opt for surgical repairs (e.g., fusion) that attempt to stabilize the spine, even where such surgical intervention might alter a single level or group of levels to less desirable and / or nondesirable curves. Unfortunately, current fusion procedures may further cause hyperlordosis or hyperkyphosis, which causes the adjacent segments or vertebral joints to compensate with either increased lordosis 43 or kyphosis 42, respectively (e.g., adjacent segment disease). Therefore, understanding the vertebral anatomy and variation between patients to gauge the optimal placement, orientation and the return to normal spino-pelvic balance can improve the surgeon’s precision while performing the surgery and achieve more optimal results for the patient.
[0079] FIG. 4A depicts a lateral or sagittal view of an exemplary lower lumbar region 44, with typical lumbar lordotic angular variance across one or more spinal segments 10 indicated by dotted lines. The spine’s natural lordotic and kyphotic curvatures and its angular variance are designed for even distribution of weight and flexibility of movement. These natural curves work in harmony to keep the body’s center of gravity aligned over the hips and pelvis. The article “Lumbar Lordosis: A Study of Angle Values And Of Vertebral Bodies And Intervertebral Discs Role" by Fonseca Damasceno et al., published in Acta Orthopedica Brasileira, pgs. 193-198 (2006), discloses natural or normal lordotic angles of a person’s spine at each lumbar spinal level within the lumbar region. The L1 46 normally has a typical lumbar lordosis angular range of 14 degrees to -9 degrees (46: 14 -9°); L2 48 has a typical angular range of 7 degrees to -8 degrees (48: 77-8°), L3 50 has a typical angular range of 14 degrees to -9 degrees (50: 147- 9°), L4 52 has a typical angular range of 4 degrees to -14 degrees (52: 47-14°) and L5 54 has a typical lumbar angular range of 0 degrees to -19 degrees (54: 07-19°) and / or the S1 56 has a typical angular range of - 5 degrees to -30 degrees. Thus, maintaining a mechanical balance within the sagittal plane and coronal plane by returning the patient or person to their natural lordotic or kyphotic curvatures would help facilitate equilibrium of the spine and body with minimum energy expenditure or reduction of stresses to other regions of the spine. It isdesirable to restore the spine to adequate or optimal lordosis or kyphosis as a primary surgical strategy to prevent adjacent segment disease and / or changes of load on different structures within the spine.
[0080] Figure 4B depicts an anterior-posterior (A / P) view of the lumbar spinal region 58 of FIG. 4, showing typical facet joint angles or transverse pedicle angles (TPA) 60, 62, 64, 66, 68 for each lower spinal vertebral joint, body, level or segment. The calculation of the TPA may help assist spinal implant and / or fixation screw trajectory, positioning and / or orientation onto one or more vertebral bodies in spinal region. The transverse pedicle angles (TPA) 60, 62, 64, 66, 68, the transverse pedicle width 72, the transverse sagittal pedicle angle 82 and the transverse pedicle height or diameter 80, may vary between each vertebral spinal segment or each vertebral functional spinal unit in the different regions of the spine as disclosed in “Thoracic and Lumbar Vertebrae Morphology in Lenke Type 1 Female Adolescent Idiopathic Scoliosis Patients” b Xiobang Hu, MD, PhD et al, Int. J. Spine Surg. (2014) 8:30; “ Morphometry of the Lower Thoracic and Lumbar Pedicles and its Relevance in Pedicle Fixation, “S.P. Mohanty et al., Musculoskeletal Surgery (2018) 102:299-305; “A Comparison of Lumbar Transverse Pedicle Angles between Ethnic Groups: A Retrospective Review,” by Robert Stockton et al., BMC Musculoskeletal Disorders (2019) 20:114; and Hu et al., Thoracic and Lumbar Vertebrae Morphology in Lenke Type 1 Female Adolescent Idiopathic Scoliosis Patients, Int’l Journal of Spine Surg. (Jan. 2014), all of which are herein incorporated by reference in their entireties. The understanding of the anatomic and morphological relationship of the pedicles and vertebral bodies may help reduce pedicle screw and spinal implant malposition, as well as increase strength, stiffness and support of the spinal implant relative to vertebral body to decrease postoperative complications and pain sensation. FIG. 4C-4D displays tables disclosed in S.P. Mohanty et al. and Hu et al. with varying TPA values at each lower lumbar level and / or spine region.
[0081] FIGS. 5A-5C depict superior and sagittal views of a single vertebral body 70. Vertebral bodies normally include a pair of pedicles, which may be symmetrical and / or asymmetrically positioned relative to each other. Each pedicle can include a transverse pedicle angle 74 (see also differing pedicle angles 60, 62, 64, 66, 68 of FIG. 4B), with each pedicle having a central pedicle angle 74 and a range of medial to lateral pedicle angles 76 and 78 (which angles desirably encompass at least a portion of the pedicle, but which are angled and / or spaced apart from the central pedicle axis). Each pedicle also has a transverse pedicle height 80, a transverse pedicle width 72 and a transverse sagittal pedicle angle 82. In varying embodiments, one or more spinal implants may be inserted into one or more intervertebrallevels of a spinal segment at a desired toe-in angle and / or pair of toe-in angles. One or more of the toe-in angles and / or other orientations may match or substantially match a transverse pedicle angle 60, 62, 64, 66, 68 of a given spinal level or levels. The toe-in angle and / or orientations may match or substantially match the transverse pedicle angle 60, 62, 64, 66, 68 to further allow a fixation screw trajectory into the pedicle to follow along or be coaxial with a central axis of the pedicle in the sagittal plane. The toe-in angles and / or orientations may be different or variable according to the vertebral level.
[0082] As shown in FIG. 5A, vertebral body 70 highlights the transverse pedicle width 72 or pedicle width 72 and pedicle length 73. The pedicle width 72 and pedicle length 73 can be different at each vertebral level and each region (cervical, thoracic and lumbar). For example, the transverse pedicle width 72 in the thoracic region (T1 to T12) may comprise a pedicle width 72 range of 1 mm to 10 mm, and / or a median pedicle width 72 range of 1.5 to 6 mm. Alternatively, the transverse pedicle width 72 in the lumbar region (L1 to L5) may comprise a pedicle width 72 range of 1 mm to 15 mm with a median pedicle width of 3 mm to 10 mm. The pedicle length 73 in the lumbar region (L1 to L5) may comprise a 3 mm to 30 mm; the pedicle length 73 may comprise a width of 3 mm to 25 mm; the pedicle length 73 may comprise a width of 3 mm to 20 mm; and / or the pedicle length 73 may comprise a pedicle length of 3 mm to 15 mm. The pedicle length 73 may comprise a mean length of 5 mm to 10 mm.
[0083] In one embodiment, at least a portion of a spinal implant maximum width may match or substantially match a transverse pedicle width 72. In another embodiment, a bridge width of a bridge of a spinal implant may match or substantially match a transverse pedicle width 72. In various embodiments, a fixation screw may comprise an outer diameter that may be less or substantially less than a pedicle width and / or a pedicle height.
[0084] FIG. 5B highlights various exemplary pedicle angles 74, 76, 78 within a vertebral body 70. The transverse pedicle angle or the pedicle angle 78 is defined as the angle between the pedicle axis and a vertebral midline axis 84 as measured in the transverse plane. A vertebral body 70 further comprises an average or exemplary pedicle angle 78 that generally changes at each vertebral level and each region (cervical, thoracic and lumbar regions). For example, the transverse pedicle angle 78 in the thoracic region (T1 to T12) may comprise a pedicle angle 78 range of 5 degrees to 45 degrees, and / or a median pedicle angle 78 range of 10 degrees to 40 degrees. Alternatively, the transverse pedicle angle 78 in the lumbar region (L1 to L5) may comprise a pedicle angle 78 of 6 degrees to 40 degrees with a median pedicle angle 78 of 10 degrees to 35 degrees. However, the transverse pedicle angles 74, 76, 78 may further comprise a range or “buffer” zone, which includes angles which may deviate from the averageor exemplary pedicle angle 78, but may be maintained within the pedicle width 72. These buffer pedicle angles 76, 78, include any angle that are between the pedicle width borders (left and right borders). More specifically, the transverse pedicle angle 78 at the S1 level comprises a pedicle angle 78 range from 20 degrees to 40 degrees; at the L5 level comprises a pedicle angle 78 from 10 degrees to 35 degrees, at the L4 level comprises a pedicle angle 78 from 10 degrees to 25 degrees; at the L4 level comprises a pedicle angle 78 from 5 degrees to 25 degrees; at the L2 level comprises a pedicle angle 78 from 5 degrees to 20 degrees; and / or at the L1 level comprises a pedicle angle from zero degrees to 15 degrees.
[0085] In one embodiment, at least one spinal implant can be positioned onto a vertebral body matching or substantially matching the transverse pedicle angle 74, 76, 78. In another embodiment, a first spinal implant 94a is positioned onto a vertebral body matching or substantially matching a first transverse pedicle angle 74, 76, 78 in a first spinal region and a second spinal implant 94b is positioned onto the vertebral body matching or substantially matching a second transverse pedicle angle 74, 76, 78 in a second spinal region. The first transverse pedicle angle may be the same or different than the first transverse pedicle angle. The first spinal region may be the same or different than the second spinal region.
[0086] FIG. 5C highlights various sagittal pedicle angles 82 and the pedicle height or diameter 80 within a vertebral body 70. As previously disclosed herein, the vertebral body 70 further comprises an average or exemplary pedicle height or diameter 80 and a sagittal pedicle angle 82 that changes at each vertebral level and each region (cervical, thoracic and lumbar regions). For example, the pedicle height 80 in the thoracic region (T1 to T12) may comprise a pedicle height 80 range of 5 mm to 20 mm. Alternatively, the pedicle height 80 in the lumbar region (L1 to L5) may comprise a pedicle height 80 of 10 mm to 16 mm degrees. Moreover, the sagittal pedicle angle 82 in the thoracic region (T1 to T12) may comprise a sagittal pedicle angle 82 of 7 degrees to 25 degrees. Alternatively, the sagittal pedicle angle 8, in the lumbar region (L1 to L5) may comprise a sagittal pedicle angle 82 of 1 degree to 10 degrees. In one embodiment, the fixation screw or pedicle screw 100a, 100b may comprise an axis or trajectory, the axis or the trajectory may be positioned to match or substantially match the sagittal pedicle angle 82.
[0087] FIG. 6A-6B depicts one exemplary embodiment of the “three-columns” which support and stabilize the spine 86. The three-column spine 86 concept divides a vertebral body and / or spinal segment into three parts, including an anterior column 88, a middle column 90, and a posterior column 92 as disclosed by Denis, Ferguson et al. and / or Su. Each column 88, 90, 92 has a different contribution to stability of the spine and damage to one or more of these columns 88, 90, 92 may affect stability of a patient differently. Furthermore, it is highly recommendedthat at least two of the columns 88, 90, 92 should remain intact to have spinal stability and maintain structural integrity. Spinal stability is the ability of the spine under physiologic loads to limit patterns of displacement so as not to damage or irritate the spinal cord and nerve roots and, in addition, so as to prevent incapacitating deformity or pain due to structural changes; instability (acute or chronic) refers to excessive displacement of the spine that would result in neurologic deficit, deformity, or pain. When two of the three columns 88, 90, 92 are disrupted, such disruption can typically allow abnormal segmental motion and various complications. Typically, surgical management to correct any instabilities of the spine from degenerative diseases involve fusion. Fusion may include discectomy, decompression, and removal of facet joints, which affects two or more columns of the spine, thus affecting the stability of the spine. In a spinal fusion procedure, a surgeon will immobilize one or more vertebral segments with a variety of different instrumentation in the columns 88, 90, 92 to recover or restore the stability of the vertebrae. More recently, spinal motion implants such as the various devices depicted herein can provide stability across the 3 columns of the spine.
[0088] Total Joint Replacement Spinal Implant
[0089] FIGS. 7A-7H, 8A-8D and 9A-9B depict various views of different embodiments of a total joint replacement spinal implant 94a, 94b. The total joint replacement spinal implant 94a, 94b may also be referred to as a dynamic spinal implant 94a, 94b. The terms “dynamic intervertebral spinal implant” or “dynamic spinal implant” as used herein generally refer to an artificial intervertebral implant and / or a motion preserving and stabilization implant that provides for relative movement between adjacent vertebral bodies and further provides some level of control of the motion between the vertebrae, including the motion of flexion / extension, lateral bending and / or axial rotation. The spinal implant 94a, 94b is biomechanically designed to incorporate motion preservation features that desirably allow the implant to perform as a total disc replacement device and a total facet replacement device, because the device can mimic the functions of both the facet joint and the intravertebral disc. The spinal implant 94a, 94b can be used for the treatment of single or multi-level degenerative disease in the different spinal regions, the spinal regions including cervical, thoracic and / or lumbar.
[0090] The spinal implant embodiments 94a, 94b can comprise a superior element or component 96a, 96b, an inferior element or component 98a, 98b, and a fixation screw 100a, 100b. The spinal implant 94a, 94b may further comprise a clip or retaining clip 102a, 102b, an upper keel 104a, 104b and a lower keel 104a’, 104b’. The superior element or upper element 96a, 96b can comprise a superior, upper or first articulating element 106a, 106b. The inferior element or lower element 98a, 98b can comprise an inferior, lower or second articulatingelement or component 108a, 108b. The inferior articulating element 108a, 108b engages with the superior articulating component 106a, 106b to allow the superior element 96a, 96b to move relative to the first inferior element 98a, 98b in a controlled manner. This motion may include at least one of flexion, extension, axial rotation, left lateral flexion and right lateral flexion.
[0091] FIGS. 10A-10F, 10H-10L, 11A-11 E and 12A-12C depict several different views of different embodiments of an upper or superior element 96a, 96b. The superior element 96a, 96b comprises a superior base 110a, 110b and a superior articulating component 106a, 106b. The articulating component 106a, 106b may be coupled to the base 110a, 110b as a multi-piece assembly. Coupling may include adhesives, screws, quick release mechanisms, compression or friction coupling, ultrasonic welding, insert molding, compression molding and / or over molding. Alternatively, the articulating component 106a, 106b may be fixed with the base 110a, 110b as a one-piece component. Once the articulating component 106a, 106b is coupled to the base 110a, 110b of the superior element, the perimeter edges of the articulating component 106a, 106b should optionally be flush with the perimeter edges of the base or superior base 110a, 110b. Alternatively, the perimeter edges of the articulating component 106a, 106b may not be flush with the perimeter edges of the base or superior base 110a, 110b. The superior element or upper element 96a, 96b further comprises a superior, upper or first articulating element 106a, 106b, the superior articulating element or component 106a, 106b comprising a socket 119a, 119b.
[0092] FIGS. 10G and 10N depict side cross-sectional views of the superior or upper element 96a, 96b of FIGS. 10A-10F and 10H-10M, respectively. The superior articulating component 106a, 106b comprises a socket 119a, 119b. The socket 119a, 119b comprises an articulating surface or socket surface 168a, 168b. The cross-sectional view illustrates the socket 119a, 119b and the shape of the socket or articulating surface 168a, 168b. The socket shape comprises a dome, arch, concave or hemispherical shape. The socket 119a, 119b further comprises a centroid curvature region 111a, 111b. The centroid curvature region 111a, 111b comprises a first surface distance radius 115a, 115b, a second surface distance radius 115a’, 115b’ and a centroid curvature region height 113a, 113b positioned between the first surface distance radius 115a, 115b and the second surface distance radius 115a’, 115b’. In various embodiments, the centroid region height 113a, 113b desirably comprises at least s mm height or thickness, which in this embodiment desirably prevents excessive localized loading, premature material wear, material fatigue or material failure at or near the local or highest stress concentrations of the socket 119a, 119b during use or at rest. In addition, in this embodiment the centroid region height 113a, 113b desirably further comprises 3 mm or greater at any point within the centroidcurvature region 111a, 111 b. The centroid region height 113a, 113b comprises approximately or about 3 mm and / or at least 3 mm or greater at any point along the first surface distance radius 115a, 115b and the second surface distance radius 115a’, 115b’ within the centroid curvature region 111 a, 111b. The centroid region height 113a, 113b allows the superior articulation component 106a, 106b to withstand maximum stress values in the centroid region 111a, 111 b during compression and / or translational motion.
[0093] In some exemplary embodiments, the superior or upper element 96a, 96b may comprise a kit of different superior element implants 96a, 96b having a plurality of different total heights 120 such as shown in FIGS. 11A-11 E, to accommodate different intervertebral spacings and / or other anatomical variations in one or more spinal regions, the spinal regions including cervical, thoracic and / or lumbar regions. The different superior element implant total heights 120 may include a range of 5 mm to 20 mm; the different total heights 120 may include a range of 5 mm to 15 mm; the different total heights 120 may include a range of 7 mm to 12 mm; the different total heights 120 may include a range of 11 mm to 15 mm; and / or the different heights may include a range of 15 mm to 20 mm. The superior element height 120 ranges may be incremental by 1 mm or by 0.5 mm. The implant total height 120 can include a base height 121 and an articulating component height 123.
[0094] The superior element base height 121 may change relative to the implant total height 120, if desired. In another embodiment, the superior articulating component height 123 may stay the same or substantially the same compared to the superior element implant total height 120 and / or the superior element base height 121. Alternatively, the superior element base height 121 can change relative to the articulating component height 123. The superior element base height 121 changes while the articulating component height 123 stays the same to accommodate the superior implant total height 120. By leaving the articulating component height 123 the same while the superior element base height 121 changes allow the mechanical and material function of the articulating component to be same and / or substantially the same across the different total heights 120 of the superior element 96a, 96b.
[0095] The superior articulating component 106a, 106b may comprise an articulating component height 123. The articulating component height 123 may stay the same as the total implant height 120 changes and / or the superior base height 121 changes. The superior articulating component height 123 may comprise a height of at least 4mm; the superior articulating component height 123 may comprise a range of 4 mm to 8 mm; the superior articulating component height 123 may comprise a range of 4 mm to 6; and / or the superior articulating component height 123 may comprise a range of 5mm to 6 mm. The superiorarticulating base height 121 may comprise a range of 4 mm to 10 mm; the superior articulating base height 121 may comprise a range of 4.5 mm to 8.5 mm.
[0096] In another embodiment, the superior or upper element 96a, 96b may comprise a kit of implant components of different superior element implant lengths 122, such as shown in FIGS. 12A-12C, to accommodate different vertebral body sizes and / or other anatomical variations. The superior element implant lengths 122 may comprise generic lengths such as small, medium, large, and / or extra-large. Alternatively, the superior element lengths 122 may be offered in a range of 20 mm to 40 mm; the range of 25 mm to 35 mm; and / or the range of 30 to 40 mm. The superior element lengths 122 ranges may be incremental by 0.5 mm, 1 mm, 1.5 mm, 1.75 mm, 2 mm; the superior element lengths 122 ranges may be incremental by 0.5 mm or greater. In one embodiment, the kit may comprise a combination of at least 15 different superior element implant total lengths 122 and superior element implant total height 120.
[0097] With reference to FIGS. 7A-7H, 8A-8D, 9A-9B, 10A-10G and 10H-10N, 13A-13I and 14A-14G the superior component may include a superior base 110a, 110b comprising a first end 124 or anterior end, a second end 126 or posterior end, a third end or medial end 128 and / or a fourth end or lateral end 130. The superior base 110a, 110b may further comprise a top surface 116a, 116b, a bottom surface 138a, 138b and / or a domed surface 140a, 140b. In another embodiment, the superior base 110a, 110b further may comprise a flange 132a, 132b and a posterior wall or posterior tab 112a, 112b.
[0098] Alternatively, the superior component 96a, 96b, 96c may include a superior base 110a, 110b comprising a first end 124 or anterior end, a second end 126 or posterior end, a third end or medial end 128 and / or a fourth end or lateral end 130. The superior base 110a, 110b may further comprise a top surface 116a, 116b, a bottom surface 138a, 138b and / or a domed surface 140a, 140b. The superior base 110a, 110b further may comprise a flange 132a, 132b and a posterior wall or posterior tab 112a, 112.
[0099] In one embodiment, at least a portion of the top surface 116a, 116b of the superior base 110a, 110b may be flat or planar. In another embodiment, at least a portion of the top surface 116a, 116b may be curved, angled, sloped or and / or not flat or planar. In another embodiment, at least a portion of the top surface 116a, 116b is flat or planar and another portion of the top surface is curved, sloped or angled 138a, 138b. The angle or sloping may comprise a downward slope or angle. The slope or angle may comprise an angle of 10 degrees to 20 degrees; an angle of 12 degrees to 18 degrees; and / or an angle of 14 degrees to 16 degrees. The angled top surface portion may be positioned at the anterior end 124 of the superior base 110a, 110b. The angled top surface portion may be positioned at the medial 128 and / or thelateral ends 130. The angled top surface portion may be positioned at one or more locations, including at the anterior end 124, at the medial side 128 and / or the lateral side 130. The curving may include an arch, concave or convex shape.
[0100] At least a portion of the top surface 116a, 116b contacts the vertebra bone and / or at least a portion of the top surface 116a, 116b contacts the endplate of a vertebra and / or the endplate of the upper vertebra.
[0101] In one embodiment, the superior base 110a, 110b comprises a keel and / or an upper keel 104a, 104b. The upper keel 104a, 104b can include a height 146a, 146b and a length 118a, 118b. The upper keel 104a, 104b is disposed onto the superior base 110a, 110b and / or the upper keel 104a, 104b is disposed onto a portion of the top surface 116a, 116b of the superior base 110a, 110b. The upper keel 104a, 104b desirably extends upwardly from the superior base 110a, 110b and / or extends upwardly from a top surface 116a, 116b of the superior base 110a, 110b. The upper keel 104a, 104b may extend orthogonally or perpendicular to the superior base 110a, 110b and / or may extend orthogonal or perpendicular to a top surface 116a, 116b of the superior base 110a, 110b. At least a portion of at least one surface 125a, 125b of the upper keel 104a, 104b comprise flat or planar surfaces. At least a portion of the at least one surface 125a, 125b of the upper keel 104a, 104b desirably configured contacts the endplate of a vertebra and / or the endplate of the upper vertebra. At least a portion of the at least one surface 125a, 125b desirably contacts cancellous and / or cortical bone.
[0102] The upper keel 104a, 104b comprises a shape. The shape includes a shape substantially similar to a trapezoid, trapezium, rhombus, parallelogram and / or a sloped rectangle. The first end or anterior end of the upper keel 104a, 104b can optionally be sloped or angled to facilitate easier positioning and / or atraumatic insertion. The upper keel 104a, 104b slope or angle may comprise a range of 30 degrees to 60 degrees; may comprise a range of 40 degrees to 50 degrees; and / or may comprise a range of 43 degrees to 47 degrees.
[0103] The length 118a, 118b of the upper keel 104a, 104b extends from the posterior end or second end 126 towards the first end or anterior end 124. The length 118a, 118b of the upper keel 104a extends from the posterior end or second end 126 towards the first end or anterior end 124. The length 118a, 118b of the upper keel 104a, 104b extends between the posterior end or second end 126 and the first end or anterior end. The length 118a, 118b of the upper keel 104a, 104b may match or substantially match a length of the superior base 110a, 110b and / or the upper keel 104a may match or substantially match the length of a top surface 116a of the superior base 110a, 110b. The length 118a, 118b of the upper keel 104a, 104b aligns with and / or follows along the longitudinal axis of the superior base 110a, 110b.
[0104] In another embodiment, the upper keel 104a, 104b and / or the length 118a, 118b of the upper keel 104a, 104b may comprise or function as an additional structural support component to the superior base 110a, 110b, including acting similar to structures such as a truss, I-beam or H-beam. The upper keel 104a, 104b is coupled to and / or contacts a portion of the posterior wall or tab 112a, 112b. The upper keel 104a, 104b intersects perpendicularly and / or substantially perpendicular to the posterior wall or tab 112a, 112b. The upper keel 104a, 104b alone and / or in combination with the upper keel 104a, 104b to the posterior wall or tab 112a, 112b may be helpful in supporting the superior base 110a, 110b to provide a more rigid structure, resist bending and / or resist shear. Furthermore, such structural components may assist with supporting the superior base 110a, 110b to provide a more rigid structure within the centroid region 111a, 111b due to the thinner height 113a, 113b during motion, as well as resist bending and / or resist shear when coupled to the posterior wall or tab 112a, 112b.
[0105] In another embodiment, the superior base 110a, 110b further comprises a posterior wall or tab 112a, 112b. The posterior wall or tab 112a, 112b is positioned on the second end or posterior end 126 of the superior base 110a, 110b. The posterior wall 112a, 112b may include an anterior facing surface 142a, 142b and a posterior facing surface 144a, 144b that is flat or planar. The posterior wall or tab 112a, 112b may include an anterior facing surface 142a, 142b and a posterior facing wall 144a, 144b that is not flat or not planar. The posterior wall 112a, 112b extends upwardly to extend past or beyond the top surface 116a, 116b of the superior base 110a, 110b. The posterior end of the upper keel 104a, 104b intersects with the anterior facing surface 142a, 142b of the posterior wall or tab 112a, 112b. The posterior end of the upper keel 104a, 104b intersects orthogonally or perpendicularly with the anterior facing surface 142a, 142b of the posterior wall or tab 112a, 112b. At least a portion of the anterior facing surface 142a, 142b of the posterior wall or tab 112a, 112b contacts bone and / or at least a portion of the anterior facing surface 142a, 142b of the posterior wall or tab 112a, 112b contacts the posterior facing surface of the vertebra and / or the upper vertebra. At least a portion of the anterior facing surface 142a, 142b of the posterior wall or tab 112a, 112b contacts the apophyseal ring on the vertebra. The apophyseal ring is a secondary ossification center of the vertebral endplate connected to the intervertebral disc. It is firmly attached to disc fibrous annulus through Sharpey fibers.
[0106] The posterior wall or tab 112a, 112b can desirably function as a positive stop limiter or provide tactile feedback to surgeons for proper placement or positioning of the superior element 96a, 96b between the upper and lower vertebra and / or within the disc space. The proper positioning or placement may include the proper distance of the superior element 96a, 96bbetween the anterior end and the posterior end of the disc space. The proper positioning or placement may further include the center of rotation (COR) distance 127a, 127b to approximate the neutral or fixed center of rotation of a vertebral body. Desirably this structure may further prevent the superior element 96a, 96b from migrating anteriorly in an unwanted manner during placement, motion translation, and / or long-term use. Furthermore, the position of the posterior wall or tab 112a, 112b may be monitored with fluoroscopy or other visualization methods during surgery to determine the progress of the implantation and to confirm when the superior element 96a, 96b has been correctly implanted - such as by providing confirmation that the posterior wall or tab 112a, 112b contacts and / or is recessed against a posterior wall of the vertebral body or the upper vertebral body.
[0107] The superior base 110a, 110b further comprises a flange 132a, 132b. The flange 132a, 132b is disposed onto the anterior end 124 of the superior base 110a, 110b and the posterior end 126. The flange 132a, 132b is spaced apart from the superior base 110a, 110b to create a recessed channel 134a, 134b that is positioned in the anterior end 124 and the posterior end 126 of the superior base 110a, 110b. The recessed channel 134a, 134b is sized and configured to receive a portion of the superior articulating element 106a, 106b. The flange 132a, 132b comprises a flange width 129a, 129b, the flange width 129a, 129b is sized and configured to be disposed into a portion of the superior articulating element 106a, 106b. At least a portion of the flange 132a, 132b comprises a smaller width 129a, 129b than the superior base width 131a, 131b of superior base 110a, 110b. Alternatively, the first contacting surface 136a, 136b comprises a larger width than the flange width 129a, 129b. The first contacting surface 136a, 136b extends beyond the flange 132a, 132b. The flange 132a, 132b substantially surrounds the perimeter of the superior base 110a, 110b leaving an opening or recess in the center of the superior base 110a, 110b. The opening or recess extends through the medial 128 and / or the lateral ends 130 of the superior base 110a, 110b. The flange width 129a, 129b is sized and configured to be disposed into a gutter or channel 152a, 152b of the superior articulating element 106a, 106b. The flange width 129a, 129b is sized and configured to engage with the channel or gutter 152a, 152b of the superior articulating element or component 106a, 106b.
[0108] In various embodiments, the flange 132a, 132b comprises a first portion and a second portion. The first portion of the flange 132a, 132b is disposed on the anterior end 124 of the superior base 110a, 110b and the second portion of the flange 132a, 132b is disposed on the posterior end 126 of the superior base 110a, 110b. The first portion of the flange 132a, 132b does not connect to the second portion of the flange 132a, 132b. The third end or medial end 128 and / or a fourth end or lateral end 130 of the superior base 110a, 110b does not include aflange 132a, 132b leaving the center portion of the superior base 110a, 110b exposed or open. The flange 132a, 132b comprises a flange inside surface 133a, 133b and a flange outside surface 135a, 135b. The flange channel 134a, 134b, the flange inside surface 133a, 133b, and / or the flange outside surface 135a, 135b contact and / or engage with a portion of the superior articulation component 106a, 106b. The flange inside surface 133a, 133b provides a stop for the articulation component 106a, 106b from migrating or sliding anteriorly and / or posteriorly. The open or exposed center portion of the superior base 110a, 110b allows the superior element 96a, 96b to be axially rotated on the inferior articulation component 108a, 108b and allow further degrees of motion during flexion and / or extension.
[0109] In various embodiments, the superior base 110a, 110b may comprise an instrument opening 114a, 114b. The instrument opening 114a, 114b can be sized and configured to receive an instrument and / or at least a portion of an implantation instrument. The instrument opening 114a, 114b may be uniform or non-uniform. The instrument opening 114a, 114b may include a conical shape. Instruments that may be received include a driver, a deployment tool, and / or any tool that can be inserted within the instrument opening 114a, 114b to push and / or slide the superior element 96a, 96b to the proper positioning between the upper and lower vertebral bodies. As described in FIGS. 10G and 10N, the instrument opening 114a, 114b may be tapered and / or at least a portion of the instrument opening 114a, 114b may be tapered.
[0110] In various embodiments, the superior base 110a, 110b may comprise a second contacting surface or bottom surface 138a, 138b. The second contacting surface or bottom surface 138a, 138b is an inferior facing surface which is sized and configured to receive a portion of the top surface 154a, 154b of the upper articulating component 106a, 106b. The second contacting surface 138a, 138b of the superior base 110a, 110b is recessed from the flange 132a, 132b and / or the second contacting surface or bottom surface 138a, 138b of the superior base 110a, 110b is below the inferior facing surface of the flange 132a, 132b. In another embodiment, the superior base 110a, 110b comprises a third contacting surface and / or a domed surface 140a, 140b. The third contacting surface or domed surface 140a, 140bcomprises a shape, the shape includes a hemispherical shape, a convex shape, arch shape, a dome shape and / or any combination thereof. The third contacting surface or domed surface 140a, 140bis sized and configured to receive the concave protrusion 152a, 152b of the superior articulating element 106a, 106b. The third contacting surface or domed surface 140a, 140bengaging with the concave protrusion 152a, 152b of the superior articulating element 106a, 16b allows the centroid curvature region 111a, 111b to maintain at least 3 mm of centroid curvature region height 113a, 113b and / or approximately 3 mm of centroid curvature regionheight 113a, 113b to prevent material fatigue, wear or stress locations during short and longterm translational motion.
[0111] In various embodiments, the superior base 110a, 110b comprises a material. The material may include metal, polymers or ceramic and / or any combination thereof. The metals may comprise titanium, titanium alloys, cobalt-chrome alloys, platinum, stainless steel and / or any combination thereof. More specifically, the metal includes titanium and / or cobalt-chrome molybdenum (CoCrMo). The polymers may include thermoplastic or thermoset polymers. The polymers may further include carbon fiber, polyether ether ketone (PEEK), polyethylene (PE), ultra-high molecular weight polyethylene (UHMWPE), polycarbonate (PC), polypropylene (PP) and / or any combination thereof. The ceramics may include alumina ceramics, Zirconia (ZrO2) ceramics, Calcium phosphate or hydroxyapatite (Ca10(PO46(OH)2) ceramics, titanium dioxide (TiO2), silica (SiO2), Zinc Oxide (ZnO) and / or any combination thereof. The materials may be manufactured using traditional methods and / or using 3D printed techniques known in the art. Furthermore, the material may comprise a porous material, the porous material including (but not limited to) porous metal, porous polymer, porous ceramic and / or any combinations thereof.
[0112] In another embodiment, the material may be further antioxidant stabilized. The stabilized antioxidants may comprise Vitamin E or Vitamin C. The antioxidants may be incorporated into the material by blending the antioxidant into the material for subsequent cross-linking and / or diffusing the antioxidant into the material. The material may be further cross-linked before or after antioxidant stabilization.
[0113] In various embodiments, at least one surface 116a, 116b, 138a, 138b, 140a, 140bof the superior base 110a, 110b may comprise a coating and / or surface texture 148 to desirably help facilitate healing or osseointegration, and / or to better accommodate loading forces and / or wear, such as shown in FIG. 14H. Alternatively, at least one or more surfaces 116a, 116b, 138a, 138b, 140a, 140b of the superior base 110a, 110b comprises a coating and / or surface texture 148a, 14b. At least a portion of the top surface 116a, 116b of the superior base 110a, 110b comprises a coating (not shown) and / or a surface texture or surface finish 148. At least a portion of the first contacting surface 136a, 136b comprises a coating and / or surface texture 148. At least a portion of the second contacting surface 138a, 138b comprises a coating and / or surface texture 148. At least a portion of the third contacting surface 140a, 140b comprises a coating and / or surface texture 148. Accordingly, the coating and / or surface texture 148 disposed onto each of the one or more top surfaces 116a, 116b, the first contacting surface 136a, 136b, the second contacting surface or bottom surface 138a, 138b, and / or the third contacting surface or domed surfaces 140a, 140bof the superior base 110a, 110b may be thesame surface texture 148. the coating and / or surface texture 148 disposed onto each of the one or more top surfaces 116a, 116b, the first contacting surface 136a, 136b, the second contacting surface 138a, 138b, and / or the third contacting surfaces 140a, 140bof the superior base 110a, 110b may be different.
[0114] The surface textures or finishes 148 may comprise threads, flutes, grooves, and / or teeth that may include various shapes. The various shapes may include tapered, stepped, conical and / or paralleled, flat, pointed, and / or rounded. The surface textures or finishes 148 may further comprise roughened surfaces or porous surfaces, including turned, blasting, sand blasting, acid etching, chemical etching, dual acid etched, plasma sprayed, anodized surfaces, and / or any combination thereof. The surface textures or finishes 148 may further include a polish surface finish or texture. The polished surface may be accomplished using different techniques, mechanical polishing, chemical polishing, electrolytic polishing, and / or any combination thereof. Polished surfaces can be measured in “Ra” micrometers ( m) or microinches (pin.). The Ra may comprise a range of 0.025 to 1.60 pm; may comprise a range of 0.025 to 0.30 pm; may comprise a range of 0.025 to 0.20 pm; may comprise a range of 0.025 to 0.10 pm; and / or may comprise a range of 0.05 to 0.20 pm. Accordingly, the Ra may comprise at least 0.05 pm or higher; at least 0.10 pm or higher and / or at least 0.8 pm or higher. Surface structure is often closely related to the friction and wear properties of a surface. A surface with a large Ra value will usually have somewhat higher friction and wear quickly, and a surface with a lower Ra value will have a lower friction and enhanced part performance and / or prevent or reduce unwanted adhesion of molecules or components to surface(s) (e.g., surfaces are smooth, shiny and less porous). A polished surface has many further advantages, including improving cleanability, increases resistance to corrosion, reduces adhesive properties (for cells or other blood components to attach to), increases biocompatibility, increased light reflection for enhanced radiopacity, etc.
[0115] The coatings may include inorganic coatings or organic coatings. The coatings may further include a metal coating, a polymer coating, a composite coating (ceramic-ceramic, polymer-ceramic, metal-ceramic, metal-metal, polymer-metal, etc.), a ceramic coating, an antimicrobial coating, a growth factor coating, a protein coating, a peptide coating, an anti-coagulant coating, an antioxidant coating and / or any combination thereof. The antioxidant coatings may comprise naturally occurring or synthetic compounds. The natural occurring compounds comprises Vitamin E and Vitamin C (tocotrienols and tocopherols, in general), phenolic compounds and carotenoids. Synthetic antioxidant compounds include a-lipoic acid, N-acetyl cysteine, melatonin, gallic acid, captopril, taurine, catechin, and quercetin, and / or anycombination thereof. The coatings can be impregnated, applied and / or deposited using a variety of coating techniques. These techniques include sintered coating, electrophoretic coating, electrochemical, plasma spray, laser deposition, flame spray, biomimetic deposition and wet methods such as sol-gel-based spin- and -dip or spray-coating deposition have been used most often for coating implants.
[0116] The metal coatings may comprise titanium, titanium alloys, cobalt-chrome alloys, platinum and stainless steel, and / or any combination thereof. More specifically, the metal coating includes titanium and / or cobalt-chrome molybdenum (CoCrMo). The polymer coatings may include thermoplastic or thermoset polymers. The polymers may further include carbon fiber, polyether ether ketone (PEEK), polyethylene (PE), ultra-high molecular weight polyethylene (UHMWPE), polycarbonate (PC), polypropylene (PP) and / or any combination thereof. The ceramic coatings may include alumina ceramics, Zirconia (ZrO2) ceramics, Calcium phosphate or hydroxyapatite (Ca10(PO46(OH)2) ceramics, titanium dioxide (TiO2), silica (SiO2), Zinc Oxide (ZnO) and / or any combination thereof.
[0117] With reference to FIGS. 7A-7H, 8A-8D, 9A-9B, 10A-10G, 10H-10N, 11A-11 E, 12A-12C and 15A-15G, and 15H-15N, the superior element 96a, 96b may comprise an articulating element or component 106a, 106b. The articulating element 106a, 106b comprises a body 150a, 150b and a socket 119a, 119b. The body or base 150a, 150b comprises a bottom surface 154a, 154b, a top surface 158a, 158a’, 158b, 158b’, an anterior end 160 and a posterior end 162. The bottom surface 154a, 154b of the body 150a, 150b is flat or planar and / or engages or contacts the second contacting surface or bottom surface 138a, 138b of the superior base 110a, 110b. The bottom surface 154a, 154b is a superior facing surface. The bottom surface 154a, 154b further comprises a protrusion 152a, 152b that extends away from the bottom surface 154a, 154b of the articulating component 106a, 106b. The protrusion 152a, 152b is normal to the plane of the bottom surface 154a, 154b or extends perpendicular to the plane of the bottom surface 154a, 154b. The protrusion 152a, 152b comprises a shape, the shape includes a dome shape, hemispherical shape, and / or a convex shape. The protrusion 152a, 152b is sized and configured to be disposed or engage with the third contacting surface or domed surface 140a, 140bof the base 110a, 110b of the superior element 96a, 96b.
[0118] The bottom surface 154a, 154b of the body 150a, 150b further comprises an articulation channel 156a, 156b. The articulation channel 156a, 156b surrounds and / or follows the perimeter of the bottom surface 154a, 154b and / or the body 150a, 150b of the articulating element 106a, 106b. The articulation channel 156a, 156b substantially surrounds and / or substantially follows the perimeter of the bottom surface 154a, 154b and / or the body 150a, 150bof the articulating element 106a, 106b. The channel 156a, 156b is sized and configured to receive the flange 132a, 132b of the base 110a, 110b of the superior element. The channel 156a, 156b may comprise a frictional fit and / or press fit with the flange 132a, 132b of the base 110a, 110b of the superior element 96a, 96b to prevent the migration of the base 110a, 110b relative to the articulating element 106a, 106b of the superior element 96a, 96b. The body 150a, 150b comprises a top surface 158a, 158a’, 158b, 158b’ and a longitudinal axis 166a, 166b. Alternatively, the body 150a, 150b comprises a first top surface 158a, 158b, and a second top surface 158a’, 158b’, and a longitudinal axis 166a, 166b. The top surface or the first top surface 158a, 158b is positioned proximate to the anterior end 160, and the top surface or the second top surface 158a’, 158b’ is positioned proximate and / or adjacent to the posterior end 162. The socket 119a, 119b comprises a first anterior facing wall 164a, 164b and a second posterior facing wall 164a’, 164b’. The socket 119a, 119b may further comprise a side walls, including a medial wall 167a, 167b and a lateral wall 167a’, 167b’. The socket 119a, 119b may further comprise an articulation surface 168a, 168b that is positioned between a first anterior facing wall 164a, 164b and a second posterior facing wall 164a’, 164b’. _The socket 119a, 119b extends outwardly toward the inferior direction. The socket 119a, 119b is disposed between first top surface 158a, 158b positioned adjacent or proximate to the anterior end 160, and the second top surface 158a’, 158b’ positioned adjacent or proximate to the posterior end 162. Alternatively, the socket 119a, 119b is positioned between the first top surface 158a, 158b of the base 150a, 150b and the second top surface 158a’, 158b’ of the base 150a, 150b. The socket 119a, 119b aligns with the central axis 166a, 166b of the articulation component 106a, 106b.
[0119] The top surfaces 158a, 158a’, 158b, 158b’ may comprise a flat or planar surface. The top surfaces 185a, 158a’, 158b, 158b’ may comprise a curved, arched or convex surface. The top surfaces 185a, 158a’, 158b, 158b’ may comprise an angled surface or angled orientation, the angled surface or orientation comprises an angle 163. The top surfaces 158a, 158a’, 158b, 158b’ may comprise a flat and angled surface, the angled surface comprises an angle 163. The socket 119a, 119b extends away from the top surfaces 158a, 158a’, 158b, 158b’ of the body or base 150a, 150b. The angle 163 may include a range of 0.25 degrees to 7 degrees; the range may include 1 degree to 5 degrees; and / or the range may include 3 degrees to 5 degrees. Alternatively, the angle 163 may include 7 degrees or less; the angle 163 may include 5 degrees or less; and / or the angle may include 5 degrees or more. The top surfaces
[0120] In another embodiment, the body 150a, 150b comprises a first top surface 158a, 158b with a first top surface angle or orientation and a second top surface 158a’, 158b’ with a secondtop surface angle orientation or surface type. The first surface orientation or angle may be the same orientation as the second surface orientation or angle. The first surface orientation or angle may be a different orientation than the second surface orientation or angle. The first surface orientation or angle may comprise flat, angled, curved and / or any combination thereof. The second surface orientation or angle may comprise flat, angled, curved and / or any combination thereof. In exemplary embodiment, the first surface orientation or angle may comprise a flat or planar surface and / or at a zero degrees angle, and the second surface orientation may comprise a flat / planar and an angled surface, the angled surface comprises an angle of at least 5 degrees.
[0121] The socket 119a, 119b comprises a plurality of walls 164a, 164a’, 164b, 164b’, 167a, 167a’, 167b, 167b’. Each of the plurality of walls 164a, 164a’, 164b, 164b’, 167a, 167a’, 167b, 167b’ face a different direction and / or different orientation. The different directions include an anterior facing wall 164a, 164b, a posterior facing wall 164a’, 164b’, a medial facing wall 167a, 167b, and a lateral facing wall 167a’, 167b’. At least two of the plurality of walls 164a, 164a’, 164b, 164b’ extend from the top surfaces 158a, 158a’, 158b, 158b’ at an angle and / or an oblique orientation 161a, 161a’, 161b, 161 b’ from the longitudinal axis 166a, 166b. Each of the at least two of the plurality of walls 164a, 164a’, 164b, 164b’ comprise the same angle or a different angle.
[0122] In another embodiment, the anterior facing wall 164a, 164b comprises a first angle or an orientation 161a, 161 b. The posterior facing wall 164a’, 164b’ comprises a second angle or orientation 161a’, 161 b’. The first angle or orientation 161a, 161 b and the second angle or orientation 161a’, 161 b’ are the same angle or orientation. The first angle or orientation 161a, 161b and the second angle or orientation 161a’, 161 b’ are a different angle or orientation. In another embodiment, first wall 164a, 164b extends from the top surfaces 158a, 158b at a first angle and / or a first oblique orientation 161a, 161b and / or a second wall 164a’, 164b’ extends at a second angle or a second oblique orientation 161a’, 161b’. The first angle 161a, 161b may be the same as the second angle 161a’, 161b’. The first angle 161a, 161 b may be different than the second angle 161a’, 161 b’. In one embodiment, at least a portion of the angle or orientation 161a, 161 b of the anterior facing wall 164a, 164b of the socket 119a, 119b engages or contacts a portion of the posterior facing wall 184a, 184b of the first stop 180a, 180b during flexion.
[0123] The angle and / or the oblique orientation 161a, 161a’, 161b, 161b’ may comprise a range of 1 degree to 20 degrees; a range of 5 degrees to 15 degrees; a range of 10 degrees to 20 degrees; a range of 15 degrees to 20 degrees; and / or range of 5 degrees to 10 degrees. Accordingly, the angle and / or orientation 161 comprises at least 10 degrees or greater and / or10 degrees or less. At least a portion of the walls 164a, 164a’, 164b, 164b’ contact at least one surface of the inferior element 98a, 98b.
[0124] Accordingly, at least two of the plurality of walls 167a, 167a’, 167b, 167b’ extend from the top surfaces 158a, 158a’, 158b, 158b’ perpendicular or normal to the planes of the top surfaces 158a, 158b of the body 150a, 150b. The plurality of side walls 167a, 167a’, 167b, 167b’ are flat or planar. The socket 119 further comprises an articulating surface 168a, 168b. The articulating surface 168a, 168b further comprises a shape and a size. The shape is sized and configured to receive the articulating component 108a, 108b of the inferior element 98a, 98b. The shape of the articulating surface 168a, 168b comprises a concave, an arch, a hemispherical shape. The size comprises a diameter of at least 10 mm to 20 mm; a diameter of 10 mm to 16 mm; a diameter of 15 mm to 20 mm; a diameter of 14 mm to 18 mm; a diameter of at least 15 mm or greater; a diameter of at least 16 mm or greater; a diameter of at least 16 mm or less and / or any combination thereof. The size of the superior articulating surface 168a, 168b of the superior articulation component 106a, 106b may match or substantially match the size of the inferior articulating surface 228a, 228b of the inferior articulation component 108a, 108b.
[0125] In various embodiments, the superior articulating component 106a, 106b of the superior element 96a, 96b comprises a material, which material may the same or different from the material of which the superior base 110a, 110b is comprised. The material may include metal, polymers or ceramic. The metals may comprise titanium, titanium alloys, cobalt-chrome alloys, platinum, stainless steel and / or any combination thereof. More specifically, the metal may include titanium and / or cobalt-chrome molybdenum (CoCrMo). The polymers may include thermoplastic or thermoset polymers. The polymers may further include carbon fiber, polyether ether ketone (PEEK), polyethylene (PE), ultra-high molecular weight polyethylene (UHMWPE), polycarbonate (PC), polypropylene (PP) and / or any combination thereof. The polymers may further include cross-linking. The ceramics may include alumina ceramics, Zirconia (ZrO2) ceramics, Calcium phosphate or hydroxyapatite (Ca10(PO46(OH)2) ceramics, titanium dioxide (TiO2), silica (SiO2), Zinc Oxide (ZnO) and / or any combination thereof. The materials may be manufactured using traditional methods and / or using 3D printed techniques known in the art. Furthermore, the material may comprise a porous material, the porous material includes porous metal, porous polymer, porous ceramic and / or any combination thereof.
[0126] In another embodiment, the material may be further antioxidant stabilized. The stabilized antioxidants may comprise Vitamin E or Vitamin C. The antioxidants may be incorporated into the material by blending the antioxidant into the material for subsequent cross-linking and / ordiffusing the antioxidant into the material. The material may be further cross-linked before or after antioxidant stabilization.
[0127] As previously noted, the material of the articulating component 106a, 106b of the superior element 96a, 96b may be the same as the material of the superior base 110a, 110b of the superior element. The material of the articulating component 106a, 106b of the superior element 96a, 96b may be different as the material of the base 110a, 110b of the superior element 96a, 96b.
[0128] In another embodiment, at least one surface 158a, 158a’, 158b, 158b’, 164a, 164a’, 164b, 164b’, 168a, 168b of the articulating component 106a, 106b comprises a coating and / or surface texture (not shown) to help facilitate healing, osseointegration, loading forces and / or wear. Alternatively, at least two or more surfaces 158a, 158a’, 158b, 158b’, 164a, 164a’, 164b, 164b’, 168a, 168b of the articulating component 106a, 106b comprises a coating and / or surface texture. At least a portion of the top surface 158a, 158b comprises a coating (not shown) and / or a surface texture or surface finish. At least a portion of one or more of the surfaces 158a, 158a’, 158b, 158b’, 164a, 164a’, 164b, 164b’, 168a, 168b comprises a coating and / or surface texture. The coating and / or surface finishes of the articulating component 106a, 106b of the superior element 96a, 96b may be the same as the coating of the base 110a, 110b of the superior element. The coating and / or surface finishes of the articulating component 106a, 106b of the superior element 96a, 96b may be different as the coating of the base 110a, 110b of the superior element 96a, 96b. Accordingly, the coating and / or surface finishes disposed on each of the surfaces 158a, 158a’, 158b, 158b’, 164a, 164a’, 164b, 164b’, 168a, 168b of the articulating component 106a, 106b may be the same or different.
[0129] The surface textures or finishes may comprise threads, flutes, grooves, and / or teeth that may include various shapes. The various shapes may include tapered, stepped, conical and / or paralleled, flat, pointed, and / or rounded. The surface textures or finishes may further comprise roughened surfaces or porous surfaces, including turned, blasting, sand blasting, acid etching, chemical etching, dual acid etched, plasma sprayed, anodized surfaces, and / or any combination thereof. The surface textures or finishes may further include a polish surface finish. The polished surface may be accomplished using different techniques, mechanical polishing, chemical polishing, electrolytic polishing, and / or any combination thereof. Polished surfaces can be measured in “Ra” micrometers (pm) or microinches ( / / in.). The Ra may comprise a range of 0.025 to 1 .60 pm; may comprise a range of 0.025 to 0.30 m; may comprise a range of 0.025 to 0.20 pm; may comprise a range of 0.025 to 0.10 pm; and / or may comprise a range of 0.05 to 0.20 pm. Accordingly, the Ra may comprise at least 0.05 pm or higher; at least 0.10 pmor higher and / or at least 0.8 m or higher. Surface structure is often closely related to the friction and wear properties of a surface. A surface with a large Ra value will usually have somewhat higher friction and wear quickly, and a surface with a lower Ra value will have a lower friction and enhanced part performance and / or prevent or reduce unwanted adhesion of molecules or components to surface(s) (e.g., surfaces are smooth, shiny and less porous). A polished surface has many further advantages, including improving cleanability, increases resistance to corrosion, reduces adhesive properties (for cells or other blood components to attach to), increases biocompatibility, increased light reflection for enhanced radiopacity, etc.
[0130] The coatings may include inorganic coatings or organic coatings. The coatings may further include a metal coating, a polymer coating, a composite coating (ceramic-ceramic, polymer-ceramic, metal-ceramic, metal-metal, polymer-metal, etc.), a ceramic coating, an antimicrobial coating, a growth factor coating, a protein coating, a peptide coating, an anti-coagulant coating, an antioxidant coating and / or any combination thereof. The antioxidant coatings may comprise naturally occurring or synthetic compounds. The natural occurring compounds comprises Vitamin E and Vitamin C (tocotrienols and tocopherols, in general), phenolic compounds and carotenoids. Synthetic antioxidant compounds include a-lipoic acid, N-acetyl cysteine, melatonin, gallic acid, captopril, taurine, catechin, and quercetin, and / or any combination thereof. The coatings can be impregnated, applied and / or deposited using a variety of coating techniques. These techniques include sintered coating, electrophoretic coating, electrochemical, plasma spray, laser deposition, flame spray, biomimetic deposition and wet methods such as sol-gel-based spin- and -dip or spray-coating deposition have been used most often for coating implants.
[0131] With reference to FIGS. 7A-7H, 8A-8D, 9A-9B, 16A-16H and 17A-17F the lower or inferior element 98a, 98b comprises an articulating element 108a, 108b, a base or body and / or inferior base 216a, 216b, and a bridge 174a, 174b. The lower or inferior element 98a, 98b further comprises an anterior end 185, a posterior end 187, a medial end 191 and a lateral end 189. The lower inferior element 98a, 98b and / or the inferior base 216a, 216b comprises a first stop 180a, 180b and second stop 178a, 178b.
[0132] In various embodiments, the inferior element 98a, 98b comprises a base or a body 216a, 216b. The base 216a, 216b comprises a bottom surface 218a, 218b and a top surface 196a, 196b, 198a, 198b. At least a portion of the bottom surface 218a, 218b engages or contacts the inferior vertebral body. At least a portion of the bottom surface 218a, 218b engages or contacts the endplate of the inferior vertebral body. At least portion of the bottom surface 218a, 218b engages or contacts the cancellous bone and / or the cortical bone of the inferior vertebral body.Accordingly, at least a portion of the bottom surface 218a, 218b comprises a flat or planar surface. At least a portion of the bottom surface 218a, 218b may comprise a curved or angled surface. The at least a portion of the bottom surface 218a, 218b extends anteriorly at an angle 235a, 235b. The at least a portion of the bottom surface 218a, 218b extends anteriorly and upwardly towards the superior direction at an angle 235a, 235b. Alternatively, the entire bottom surface 218a, 218b comprises a flat or planar surface. The angle 235a, 235b of at least a portion of the body or base 216a, 216b and / or the bottom surface 218a, 218b comprises at 10 degrees or greater; an angle of 12 degrees or greater; an angle of 15 degrees or greater. Alternatively, the angle 235a, 235b of at least a portion of the body or base 216a, 216b and / or the bottom surface 218a, 218b comprises an angle of at least 20 degrees or less; an angle of 18 degrees or less; an angle of 15 degrees or less. The angle 235a, 235b of at least a portion of the body or base 216a, 216b and / or the bottom surface 218a, 218b comprises a range of 5 to 20 degrees; a range of 10 to 20 degrees; a range of 15 to 20 degrees; a range of 10 to 15 degrees; and / or a range of 13 to 18 degrees.
[0133] The inferior base 216a, 216b may comprise a plurality of base widths 220a, 220b, 222a, 222b as shown in FIGS. 16G and 17E. The plurality of base widths 220a, 220b, 222a, 222b may be uniform or non-uniform. The non-uniformity of the plurality of base widths 220a, 220b, 222a, 222b may include at least a portion that is tapered 222a. The tapered portion 222a, 222b includes a smaller width than the base width 220a, 220b. In another embodiment, the inferior base 216a, 216b comprises a first width 220a, 220b and a second width 222a, 222b. The second width 222a, 222b may be the same width as the first width 220a, 220b. The second width 222a, 222b may be a different width as the first width 220a, 220b. The first width 220a, 220b comprises a smaller width than the second width 222a, 22b. Alternatively, the second width 222a, 222b may comprise a larger width or a smaller width compared to the first width 220a, 220b. The first base width, the second base width, and / or plurality of base widths 220a, 220b, 222a, 222b may comprise a width of at least 10 mm or greater; a width of 12 mm or greater; a width of 15 mm or greater. Alternatively, the base width 220a, 220b, 222a, 222b may comprise a width of 10 mm to 20 mm; a width of 10 mm to 15 mm; a width of 12 mm to 15 mm; and / or any combination thereof.
[0134] The inferior base 216a, 216b may comprise a shape, the shape may include a uniform shape or a non-uniform shape. The shape may further include an oval, an ellipse, a rectangle, a rounded rectangle. At least one end of the inferior base 216a, 216b may be tapered. At least the anterior end 184 of the inferior base 216a, 216b may be tapered. The inferior base width 220a, 220b, 222a, 222b may be larger than the bridge width 214a, 214b. Each of the plurality ofinferior base widths 220a, 220b, 222a, 222b may be larger than the bridge width 214a, 214b. Alternatively, at least a portion of the pluralities of base widths 220a, 220b, 222a, 222b comprises a larger width than the bridge width 214a, 214b. The second width 222a may comprise a larger width than the bridge width 214a, 214b. The inferior base width 220a, 220b, 222a, 222b may include at least 1.5 times larger than the bridge width 214a, 214b. The base width 220a, 220b, 222a, 222b may include at least 2 times larger than the bridge width 214a, 214b. The inferior base width 220a, 220b, 222a, 222b may include at least 1.5 to 1.7 times larger than the bridge width 214a, 214b.
[0135] The inferior element 98a, 98b and / or the inferior base 216a, 216b may further comprise a first stop 180a, 180b and a second stop 180a, 180b. The first stop 180a, 180b extends upwardly from the base or inferior base 216a, 216b. The first stop 180a, 180b extends anteriorly and upwardly towards the superior direction from the base or inferior base 216a, 216b. Alternatively, the first stop 180a, 180b and the second stop 178a, 178b are disposed onto the inferior base 216a, 216b. The first stop 180a, 180b and the second stop 178a, 178b are disposed onto a top surface 196a, 196b, 198a, 198b of the inferior base 216a, 216b.
[0136] The first stop 180a, 180b is positioned adjacent or proximate to the anterior end 185 of the inferior element 98a, 98b. The first stop 180a, 180b comprises a first contact surface 182a, 182b, a first wall 184a, 184b, and a second wall 181a, 181b as shown in FIGS. 16C, 16E-16F, 16G and 17C-17F. The first contact surface 182a, 182b may comprise at least one of a flat or planar surface, an angle or angled surface 183a, 183b, a curved surface and / or any combination thereof. The curved surface may include a convex or concave shape. The curved surface may comprise a radius or diameter 193a, 193b. The curved surface may extend from a medial end 191 to the lateral end 189. The curved surface aligns perpendicular to the longitudinal axis of the inferior element 98a, 98b.
[0137] In one embodiment, the first contact surface 182a, 182b of the first stop 180a, 180b comprises an angled surface and a curved surface. The curved surface comprises a convex shape or semi-spherical shape, the curved surface comprising a radius 193a, 193b, the curved surface extending from a medial end 191 to the lateral end 189 of the inferior element or the curved surface aligns perpendicular to the longitudinal axis of the inferior element 98a, 98b. The angled surface slopes downwardly and anteriorly at a first contact surface angle 183a, 183b. The first contact surface angle 183a, 183b may comprise an angle of 5 degrees to 15 degrees; an angle of 7 degrees to 13 degrees; an angle of 9 degrees to 11 degrees; an angle of 10 degrees or greater; and / or an angle of 10 degrees or less.
[0138] The first wall 184a, 184b and / or a second wall 181a, 181 b extends perpendicular or substantially perpendicular from the first contact surface 182a, 182b. Alternatively, the first wall 184a, 184b and / or the second wall 181a, 181b may extend at an orientation angle 179a, 179b from the first contact surface 182a, 182b. The second wall 181a, 181b may extend upwardly or superiorly from the bottom surface 218a, 218b of the base 216a, 216b. Alternatively, the second wall 181a, 181b may extend downwardly or inferiorly from the first contact surface 182a, 182b. The first wall 184a, 184b may further comprise a flat or planar surface and / or a curved surface, the curved surface may comprise a concave shape or a convex shape. The first wall curved surface comprises a first wall curved surface radius. The second wall 181a, 181 b may be curved or arched in a convex shape. The first wall 184a, 184b may comprise a posterior facing wall. The second wall 181a, 181 b may comprise an anterior facing wall.
[0139] The first stop 180a, 180b of the inferior element 98a, 98b comprises a second wall 181a, 181b that faces in the anterior direction. At least a portion of the second wall 181a, 181 b and at least a portion of the first contact surface 182a, 182b extends beyond at a distance from the anterior facing surface 99a, 99b of the superior element 96a, 96b as best shown in FIG. 8D. The distance on the first contact surface 182a, 182b allows additional sliding of the superior element 96a, 96b. Alternatively, the second wall 181a, 181b extends beyond the anterior facing surface 99a, 99b of the superior element 96a, 96b. In another embodiment, at least a portion of the second wall 181a, 181 b of the first stop 180a, 180b is coaxial and / or aligns with the anterior facing surface 99a, 99b of the superior element 96a, 96b as best shown in FIG. 7C. The distance may comprise at least 3 mm or less.
[0140] The first stop 180a, 180b of the inferior element 98a, 98b further comprises the first contact surface 182a, 182b, the first contact surface 182a, 182b comprises a first contact surface area. The first contact surface area may comprise at least 0.002 mm2or greater. At least a portion of the first contact surface 182a, 182b contacts or engages with first top surface 158a, 158b of the superior articulation component 106a, 106b. At least a portion of the first contact surface area of the first contact surface 182a, 182b may match or substantially match the first top surface area of the first top surface 158a, 158b of the superior articulation component 106a, 106b. In another embodiment, the first surface area of the first contact surface 182a, 182b may be smaller than the articulating surface area of the first top surface 158a, 158b of the upper articulating component 106a, 106b of the superior element 96a, 96b. In another embodiment, the first surface area of the first contact surface 182a, 182b may be larger than the articulating surface area of the first top surface 158a, 158b of the upper articulating component 106a, 106b of the superior element 96a, 96b.
[0141] The second stop 178a, 178b is positioned towards the posterior end 187, and / or centrally located on the inferior element 98a, 98b between the bridge 174a, 174b and the first stop 180a, 180b. The second stop 178a, 178b comprises a second contact surface 188a, 188b and a third wall 186a, 186b as shown in FIGS. 16C, 16E-16F, 16G, and 17C-17F. The second contact surface 188a, 188b may comprise a flat or planar surface, it may comprise a slope, angle or angled surface 195a, 195b, it may comprise a curved surface, and / or any combination thereof. The curved surface may include a convex or concave shape, the curved surface comprising a radius, the curved surface extending from a medial end 191 to the lateral end 189 of the inferior element or the curved surface aligns perpendicular to the longitudinal axis of the inferior element 98a, 98b. The second contact surface angle 195a, 195b may comprise an angle of 5 degrees to 15 degrees; an angle of 7 degrees to 13 degrees; an angle of 9 degrees to 11 degrees; an angle of 10 degrees or greater; and / or an angle of 10 degrees or less. J n one embodiment, the second contact surface 188a, 188b comprises an angled surface 195a, 195b and a curved surface.
[0142] The second contact surface angle 195a, 195b may comprise a same angle as the first contact surface angle 183a, 183b. The second contact surface angle 195a, 195b may comprise a different angle than the first contact surface angle 183a, 183b. In another embodiment, the first contact surface 182a, 182b and the second contact surface 188a, 188b comprises the same surface. The first contact surface 182a, 182b and the second contact surface 188a, 188b comprises a different surface. The surfaces include a flat or planar surface, an angled or sloped surface, a curved surface, and / or any combination thereof.
[0143] The first curved surface radius 193a, 193b of the first contact surface 182a, 182b comprises a same radius than the second curved surface radius of the second contact surface 188a, 188b. The first curved surface radius 193a, 193b of the first contact surface 182a, 182b comprises a same radius than the second curved surface radius of the second contact surface 188a, 188b. The radius may comprise a radius of 0.05 mm to 0.25 mm; a radius of 0.05 to 0.20 mm; a radius of 0.10 mm to 0.20 mm; and / or a radius of 0.15 mm to 0.20 mm. Alternatively, the curved surface of the first contact surface 182a, 182b and / or of the second contact surface 188a, 188b may comprise 0.15 mm or greater; it may comprise 0.20 mm or greater; it may comprise at least 0.20 mm or less and / or it may comprise at least 0.25mm or less.
[0144] The second stop 178a, 178b of the inferior element 98a, 98b further comprises a second contact surface 188a, 188b, the second contact surface 188a, 188b comprises a second contact surface area. The second contact surface area may comprise at least 0.002 mm2or greater; may comprise at least 0.005 mm2or greater; may comprise 0.008 mm2or greater; and / or maycomprise at least 0.010 mm2or greater. At least a portion of the first contact surface 182a, 182b contacts or engages with first top surface 158a, 158b of the superior articulation component 106a, 106b. At least a portion of the second contact surface area of the second contact surface 188a, 188b may match or substantially match the second top surface area of the second top surface 158a’, 158b’ of the superior articulation component 106a, 106b. The second surface area of the second contact surface 188a, 188b may be smaller than the articulating surface area of the second top surface 158a’, 158b’ of the upper articulating component 106a, 106b of the superior element 96a, 96b. The second surface area of the second contacting surface 188a, 188b may be larger than the articulating surface area of the second top surface 158a’, 158b’ of the upper articulating component 106a, 106b of the superior element 96a, 96b. In one embodiment, the first contact surface area is smaller than the second contact surface area. In another embodiment, the second contact surface area is larger than the first contact surface area. Accordingly, the first contact surface area is equal to the second contact surface area.
[0145] The third wall 186a, 186b extends perpendicular or substantially perpendicular from the second contact surface 188a, 188b. Alternatively, the third wall 186a, 186b may extend at a wall orientation angle from the second contact surface 188a, 188b. The third wall 186a, 186b may comprise a flat or planar surface and / or a curved surface, the curved surface may comprise a concave shape. The third wall 186a, 186b may be curved or arched in a convex shape. The third wall curved surface comprises a third wall curved surface radius. The third wall 186a, 186b may comprise an anterior facing wall. A total range of motion (ROM) angle 179a, 179b, 179a’, 179b’ extends from a third wall 186a, 186b to the first wall 184a, 184b.
[0146] In various embodiments, the inferior component 98a, 98b may comprise a total ROM angle 179a, 179b, 179a’, 179b’. The total ROM angle may comprise at least 25 degrees or greater; may comprise an angle of at least 30 degrees or greater; may comprise an angle of at least 35 degrees or greater; may comprise a range of 34 to 38 degrees. In another embodiment, the first wall 184a, 184b may comprise an first wall orientation angle 179a, 179b, and the third wall 186a, 186b may comprise a third wall orientation angle 179a’, 179b’. The first wall orientation angle 179a, 179b and / or the third wall orientation angle 179a’, 179b’ may comprise an angle of at least 10 degrees or greater; may comprise an angle of at least 15 degrees or greater; may comprise an angle of at least 18 degrees or greater; and / or may comprise a range of 16 degrees to 20 degrees.
[0147] The first wall orientation angle 179a, 179b may comprise the same orientation angle as the third wall orientation angle 179a’, 179b’. The first wall orientation angle 179a, 179b maycomprise a different orientation angle as the third wall orientation angle 179a’, 179b’. The first wall curved surface radius of the first stop 180a, 180b comprise a same radius than the third wall curved surface radius. The first wall curved surface radius of the first stop 180a, 180b comprise a different radius than the third wall curved surface radius. The first contact surface radius 193a, 193b of the first contact surface 182a, 182b comprises a same radius of the second contact surface radius of the second contact surface 188a, 188b. The first contact surface radius 193a, 193b of the first contact surface 182a, 182b comprises a same radius of the second contact surface radius of the second contact surface 188a, 188b.
[0148] In various embodiments, the first wall 184a, 184b may comprise the same or substantially the same orientation angle 179a, 179b than the anterior facing wall 164a, 164b of the upper articulating component 106a, 106b of the superior element 96a, 96b. Alternatively, the first wall 184a, 184b may comprise a different or substantially different orientation angle 179a, 179b than the anterior facing wall 164a, 164b of the upper articulating component 106a, 106b of the superior element 96a, 96b.
[0149] In various embodiments, the third wall 186a, 186b may comprise the same or substantially the same orientation angle 179a’, 179b’ of the posterior facing wall 164a’, 164b’ of the upper articulating component 106a, 106b of the superior element 96a, 96b. The third wall 186a, 186b may match or substantially match the orientation angle 179a’, 179b’ of the posterior facing wall 164a’, 164b’ of the upper articulating component 106a, 106b of the superior element 96a, 96b. Alternatively, the third wall 186a, 186b may comprise a different or substantially different orientation angle 179a’, 179b’ than the posterior facing wall 164a’, 164b’ of the upper articulating component 106a, 106b of the superior element 96a, 96b.
[0150] Accordingly, movement or translational motion of the upper component or element 96a, 96b relative to the lower component or element 98a, 96b is desirably controlled or regulated, at least in part, by the action of the first stop 180a, 180b and the second stop 178a, 178b. At least a portion of the first contact surface 182a, 182b contacts or engages with a portion of the first top surface 158a, 158b of the articulating component 106a, 106b of the superior element 96a, 96b during flexion to create a positive stop for movement. Furthermore, at least a portion of the first wall 184a, 184b also engages or contacts with at least a portion of the anterior facing wall 164a, 164b of the articulating component 106a, 106b of the superior element 96a, 96b during flexion to create a positive stop for movement.
[0151] In another embodiment, at least a portion of the second contact surface 188a, 188b may contact or engage with a portion of the second top surface 158a’, 158b’ of the articulating component 106a, 106b of the superior element 96a, 96b during extension to create a positivestop for movement. Furthermore, at least a portion of the third wall 186a, 186b also engages or contacts with at least a portion of the posterior facing wall 164a’, 164b’ of the articulating component 106a, 106b of the superior element 96a, 96b during extension to create a positive stop for movement.
[0152] In various embodiments, an exemplary flexion and extension between the superior element 96a, 96b and the inferior element 98a, 98b will desirably comprise at least 10 degrees or greater of flexion and at least 10 degrees or greater of extension along the surfaces 182a, 182b, 188a, 188b of the first stop 180a, 180b and the second stop 178a, 178b and the walls 184a, 184b, 186a, 186b of the first stop 180a, 180b and the second stop 178a, 178b come into respective contact and serve as a positive stop. The flexion and extension between the superior element 96a, 96b and the inferior element 98a, 98b will desirably comprise at 10 degrees or greater of flexion and 10 degrees or greater of extension along the surfaces 182a, 182b, 188a, 188b of the first stop 180a, 180b and the second stop 178a, 178b and the walls 184a, 184b, 186a, 186b of the first stop 180a, 180b and the second stop 178a, 178b come into respective contact and serve as a positive stop. The flexion and extension between the superior element 96a, 96b and the inferior element 98a, 98b will desirably comprise at least 10 to 55 degrees of flexion and at least 10 to 30 degrees of extension along the surfaces 182a, 182b, 188a, 188b of the first stop 180a, 180b and the second stop 178a, 178b and the walls 184a, 184b, 186a, 186b of the first stop 180a, 180b and the second stop 178a, 178b come into respective contact and serve as a positive stop.
[0153] In various embodiments, the inferior base 216a, 216b comprises a keel and / or a lower keel 104a’, 104b’. The lower keel 104a’, 104b’ includes a height 224a, 224b and a length 226a, 226b. At least a portion of the lower keel 104a’, 104b’ extends downwardly from the inferior base 216a, 216b and / or extends downwardly from a bottom surface 218a, 218b of the inferior base 216a, 216b. At least a portion of the lower keel 104a’, 104b’ may extend orthogonally or perpendicular to the inferior base 216a, 216b and / or may extend orthogonal or perpendicular to a bottom surface 218a, 218b of the inferior base 216a, 216b. At least a portion of the bottom surface 218a, 218b is flat or planar and / or curved.
[0154] The length 226a, 226b of the lower keel 104a’, 104b’ extends from the posterior end or second end 187 of the base or inferior base 216a, 216b towards the first end or anterior end 185 of the base 216a, 216b. The length 226a, 226b of the lower keel 104b extends from the posterior end or second end 187 of the base 216a, 216b towards the first end or anterior end 185 and extends downwardly away from the inferior base 216a, 216b and / or the top surface 218 of the inferior base 216a, 216b. Alternately, the length 226a, 226b of the lower keel 104a’,104b’ extends from the second stop 178a, 178b towards the first stop 180a, 180b. The length 226a, 226b of the lower keel 104a, 104b extends substantially between or extends between the second stop 178a, 178b and the first stop 180a, 180b. The length 226a, 226b of the lower keel 104a’, 104b’ may match or substantially match a length of the inferior base 216a, 216b and / or the lower keel 104a’, 104b’ may match or substantially match the length of a bottom surface 218a, 218b of the inferior base 216a, 216b. At least one or more surfaces of the lower keel 104a’, 104b’ contacts the vertebra bone and / or at least one or more surfaces of the lower keel 104a’, 104b’ contacts the cancellous bone of the vertebra and / or the cortical bone of the lower vertebra.
[0155] The lower keel 104a’, 104b’ may comprise a shape. The shape may includes a shape substantially similar to a trapezoid, trapezium, rhombus, parallelogram and / or a sloped rectangle. The first end or anterior end 185 of the lower keel 104a’, 104b’ is sloped or at an angle to facilitate easier positioning and / or atraumatic insertion. The second end or posterior end 187 of the lower keel 104a’, 104b’ is sloped and / or at an angle to accommodate the placement of the fixation screw 100a, 100b. The angle of the second end of the lower keel 104a’, 104b’ may match or substantially match the transverse pedicle angles 82 and / or the bore axis 210a, 210b. The angle of the second end of the lower keel 104a’, 104b’ may be parallel or substantially parallel to the transverse pedicle angles 82 and / or the bore axis 210a, 210b. The length 226a, 226b of the lower keel 104a’, 104b’ may comprise a shorter or smaller length than the length 118a, 118b of the upper keel 104a, 104b of the superior base 110a, 110b.
[0156] In various embodiments, the inferior or lower element 98a, 98b and / or the inferior base 216a, 216b further comprises an inferior articulating component 108a, 108b as shown in FIGS. 8A-8D, 9A-9B, 16A-16H, 17A-17F, and 18A-18C. The inferior articulating component 108a, 108b can also be referred to as a ball or ball component or element. The ball component 108a, 108b comprises a radius or diameter and an lower articulation surface 228a, 228b. The diameter may include a diameter of; 10 mm or greater; 15 mm or greater; 20 mm or greater; and / or a range of; 10 mm to 20 mm; or 10 mm to 15 mm; or 15 mm to 20 mm; or 15 to 17 mm.
[0157] The ball or inferior articulating component 108a, 108b may comprise a uniform or non- uniform shape. The inferior articulating component and / or ball 108a, 108b comprises a uniform shape, the uniform shape includes a hemisphere or half sphere or dome shape. The non- uniform shape may include a truncated hemisphere, truncated half-sphere or truncated dome shape. The truncation is a portion of the ball 108a, 108b that is cut off by at least one plane or wall 230a, 230b, 230a’, 230b’. The at least one plane or wall 230a, 230b, 230a’, 230b’includes the left and right planes, wall or sides, the lateral or medial planes, wall or sides, and / or thesagittal planes, wall or sides. The truncation of the ball 108a, 108b helps limit the multi-axial movement of the superior element 96a, 96b relative to the inferior element 98a, 98b. More specifically, the truncation of the ball 108a, 108b helps limit the multi-axial movement or motion comprising axial rotation of the superior element 96 relative to the inferior element 98a, 98b. Axial rotation comprises an angle of rotation, the angle of rotation includes at least 1 degree or greater; at least 2 degrees or greater; at least 3 degrees or greater. In another embodiment, the angle of rotation includes 1 to 5 degrees; the angle of rotation includes 1 to 60 degrees; the angle of rotation includes 1 to 40 degrees; the angle of rotation includes 1 to 35 degrees; and / or any combination thereof. Accordingly, the ball or ball component or element 108a, 108b comprises a width 222a, 222b. The width 222a, 222b includes 8 mm or greater; 10 mm or greater; 12 mm or greater; and / or 15 mm or greater. The width may further include a range of 8 mm to 15 mm; 8 mm to 12 mm; 8 mm to 10 mm; and / or 10 mm to 15 mm; and / or 12 mm to 15 mm.
[0158] The inferior articulating component or ball 108a, 108b can extend upwardly from the inferior base 216a, 216b. The inferior articulating component or ball 108a, 108b extends upwardly toward the superior direction. The inferior articulating component or ball 108a, 108b may be disposed onto the inferior base 216a, 216b. The inferior articulating component or ball 108a, 108b may be disposed onto a top surface 196a, 196b, 198a, 198b the inferior base 216a, 216b. The inferior articulating component or ball 108a, 108b extends normal to a plane of the inferior base 216a, 216b or extends perpendicular to the plane the base 216a, 216b.
[0159] The inferior articulating component or ball 108a, 108b is desirably sized and configured to be disposed or engage with the socket 119a, 199b of the upper articulating component 106a, 106b of the superior element 96a, 96b to further allow movement or motion of the superior element 96 relative to the inferior element 98a, 98b. Accordingly, inferior articulating surface 228a, 228b of the inferior articulating component or ball 108a, 108b of the lower component 98a, 98b is sized and configured to be disposed or engage with superior articulating surface 168a, 168b of the socket 119a, 119b of the upper articulating component 106a, 106b of the superior element 96a, 96b to further allow movement or motion of the superior element 96 relative to the inferior element 98a, 98b. The motion may comprise flexion, extension, axial rotation, lateral flexion, contralateral flexion and / or any combination thereof.
[0160] The inferior articulating component or ball 108a, 108b is positioned between the first stop 180a, 180b and the second stop 178a, 178b. The inferior articulating component 108a, 108b is spaced apart from the first stop 180a, 180b and is spaced apart from the second stop 178 creating a plurality of gutters or channels 234a, 234b, 234a’, 234b’. The plurality of guttersor channels 234a, 234b, 234a’, 234b’ are sized and configured to receive a portion of the plurality of walls 164a, 164a’, 164b, 164b’ to allow motion and / or limit motion of the superior element 96a, 96b relative to the inferior element 98a, 98b. Alternatively, the first top 180a, 180b and the second stop 178a, 178b are separated by the inferior articulating component or ball 108a, 108b.
[0161] The inferior articulating component 108a, 108b may be coupled to the inferior base 216a, 216b as a multi-piece implant or multi-piece assembly. Coupling may include adhesives, screws, quick release mechanisms, compression or friction coupling, ultrasonic welding, insert molding, compression molding and / or over molding. Alternatively, the inferior articulating component 108a, 108b may be fixed to the base 216a, 216b as a one-piece or single-piece component. Once the inferior articulating component 108a, 108b is coupled to the base 216a, 216b of the inferior element 98a, 98b, the perimeter edges or surfaces 167a, 167a’, 167b, 167b’ of the articulating component 106a, 106b should be flush with the perimeter edges and / or surfaces or truncated surfaces or surfaces 230a, 230a’, 230b, 230b’ of the base or inferior base 216a, 216b. Alternatively, the perimeter edges or surfaces 167a, 167a’, 167b, 167b’ of the articulating component 106a, 106b should not be flush with the perimeter edges and / or truncated surfaces or surfaces 230a, 230a’, 230b, 230b’ of the base or inferior base 216a, 216b.
[0162] With reference to FIGS. 16A-16F and 17A-17F, the inferior or lower element 98a, 98b comprises a bridge 174a, 174b. The bridge 174a, 174b comprises a bottom surface 204a, 204b, a top surface 206a, 206b, a bridge length 212a, 212b, and a bridge width 214a, 214b. The bottom surface 204a, 204b is flat or planar. At least a portion the bottom surface 204a, 204b of the bridge 174a, 174b contacts and / or is configured to contact the pedicle, the cancellous bone and / or the cortical bone, and / or any combination thereof. The top surface 206a, 206b of the bridge 174a, 174b comprises a plurality of faceted top surfaces. The plurality of faceted surfaces helps accommodate bone surfaces and / or other tissue. The top surface 206a, 206b comprises a concave shape to help accommodate bone surfaces and / or other tissue. The bottom surface 204a, 204b of the bridge 174a, 174b is co-planar with at least a portion of the bottom surface 218a, 218b of the base 216a, 216b. The bottom surface 204a, 204b of the bridge 174a, 174b is co-planar with the bottom surface 218a, 218b of the base 216a, 216b.
[0163] The bridge 174a, 174b desirably helps to eliminate and / or decrease the opportunity for implant subsidence and provides further support in the “posterior” column of the spine, as shown in FIG. 6A-6B. At least a portion of the bridge 174a, 174b and / or the bottom surface 204a, 204b of the bridge 174a, 174b may contact and / or is configured to contact the cancellousbone (e.g., the spongy, porous bone), the cortical bone and / or the endplate. The bridge 174a, 174b and / or the bottom surface 204a, 204b of the bridge 174a, 174b is uniquely designed to help reduce or eliminate subsidence and provide additional support on the pedicle and / or below the pedicle surface due its material strength and a total surface area that contacts the cancellous or cortical bone.
[0164] The bottom surface 204a, 204b of the bridge 174a, 174b comprises a bridge surface area. This bridge bottom surface area, which the bridge surface area helps distribute the pressures exhibited by the movement of the superior element 96a, 96b relative to the inferior element 98a, 98b and helps keep the implant from “sinking” or subsiding. The bridge 174a, 174b and its bridge surface area provides further support in the “posterior” column of the spine.
[0165] The bridge 174a, 174b further comprises a bridge length 212a, 212b. The bridge length 212a, 212b may comprise at least 15 mm or greater, 20 mm or greater, and / or at least 25 mm or greater. The bridge length 212a, 212b may match or substantially match a pedicle length 73 at one segment level within one or both sides (right and left sides). The bridge length 212a, 212b may match or substantially match the pedicle length 73 at a plurality of segment levels. Alternatively, the bridge length 212a, 212b may the same at each segment level or different segment levels. Each of the bridge lengths 212a, 212b at each of the different segment levels may comprise the same bridge length 212a, 212b or it may be different.
[0166] The bridge 174a, 174b may further comprise a bridge width 214a, 214b. The bridge width 214a, 214b may comprise at least 5 mm or greater; at least 7 mm or greater; at least 10 mm or greater; and / or at least 10 mm or less. The bridge width 214a, 214b may match or substantially match the pedicle width 72 as referred to in FIG. 5B at one or a single segment level at one or both sides (right and left sides). Alternatively, the bridge width 214a, 214b may match or substantially match the pedicle width 72 at each different segment levels at one or both sides (right and left sides). Each of the bridge widths 214a, 214b at each of the different segment levels may comprise the same bridge width 214a, 214b and / or a different bridge width 214a, 214b.
[0167] In various embodiments, the inferior element 98a, 98b and / or the bridge 174a, 174b can comprise a third stop 176a, 176b. The third stop 176a, 176b may also be referred to as a fixation housing. The third stop 176a, 176b comprises a plurality of top surfaces 190a, 190b, 192a, 192b, 194a, 194b. The plurality of top surfaces 190a, 190b, 192a, 192b, 194a, 194b may comprise a flat or planar surface and / or include an angled surface. Accordingly, the plurality of top surfaces 190a, 190b, 192a, 192b, 194a, 194b may comprise curved or arched in a convex shaped surface. The plurality of top surfaces 190a, 190b, 192a, 192b, 194a, 194b may becomprise a curved or convex shape and an angled orientation or an angle. Furthermore, each of the plurality of top surfaces 190a, 190b, 192a, 192b, 194a, 194b may comprise the same surface type and / or a different surface type. The surface type may include flat or planar, curved, angle and / or any combination thereof.
[0168] In various embodiments, the third stop 176a, 176b comprises a first surface 194a, 194b, a second surface 192a, 192b, and a third surface 190a, 190b. Alternatively, the third stop 176a, 176b comprises a first surface 194a, 194b and a second surface 192a, 192b. Each of the first surface first surface 194a, 194b, a second surface 192a, 192b and / or a third surface 190a, 190b comprises a same surface. Each of the first surface first surface 194a, 194b, a second surface 192a, 192b and / or a third surface 190a, 190b comprises a different surface. Alternatively, each of the first surface first surface 194a, 194b and / or a second surface 192a, 192b comprises a same surface. Each of the first surface first surface 194a, 194b and / or a second surface 192a, 192b comprises a different surface. The surfaces may include flat or planar, curved, angle and / or any combination thereof.
[0169] The angled or slope surface may comprise an angle or slope and / or an angled orientation. The third stop angle or angled orientation may comprise a range of 1 degree to 20 degrees; a range of 1 degree to 10 degrees; a range of 1 to 5 degrees; a range of 5 degrees to 10 degrees; a range of 8-10 degrees; a range of 10 degrees to 15 degrees; and / or a range of 15 degrees to 20 degrees. Angled surfaces help facilitate deployment between the vertebrae.
[0170] The third stop 176a, 176b can be spaced apart from the bridge 174a, 174b to form a recessed retention clip channel or recessed clip channel 202a, 202b. The third stop 176a, 176b can be spaced apart from the top surface 206a, 206b of the bridge 174a, 174b to form a recessed retention clip channel or recessed clip channel 202a, 202b. Alternatively, the retention clip channel 202a, 202b is disposed between at least a portion of the bridge 174a, 174b and the third stop 176a, 176b. The retention clip channel 202a, 202b is disposed between the posterior end of the bridge 174a, 174b and the third stop 176a, 176b. The retention clip channel 202a, 202b is disposed between the posterior end of the top surface 206a, 206b of the bridge 174a, 174b and the third stop 176a, 176b.
[0171] The retention clip channel 202a, 202b is sized and configured to receive a retention clip 102a, 102b. The retention clip 102a, 102b is inserted into and / or disposed into the retention clip channel 202a, 202b until an audible sound is created or a “click” to ensure that the retention clip 102a, 102b is secured over the fixation screw 100a, 100b. At least one surface on the retention clip is flush or substantially flush to the third stop 176a, 176b.
[0172] In various embodiments, the bridge 174a, 174b can further comprise a first end and a second end. The third stop 176a, 176b is positioned adjacent to the second end of the bridge 174a, 174b, and / or the third stop 176a, 176b is positioned adjacent to the second end 187 of the inferior component 98a, 98b. The first end of the bridge 174a, 174b is coupled to the inferior base 216a, 216b and / or coupled to the posterior facing end of the inferior base 216a, 216b.
[0173] The third stop 176a, 176b further comprising a shape, the shape includes an oval, an ellipse, a rectangle and / or a rounded rectangle. The shape may be uniform or non-uniform. At least one end of the third stop 176a, 176b is tapered. At least a portion of the third stop 176a, 176b. The taper angle is approximately a range from 8 degrees to 10 degrees and / or at least 8 degrees or greater. In another embodiment, the third stop 176a, 176b also is positioned at an angle or tilted at an angle. The third stop 176a, 176b angle is a range of 5 degrees to 10 degrees; a range of 5 degrees to 8 degrees; the third stop 176a, 176b angle is at least 5 degrees or greater.
[0174] At least a portion of the bridge 174a, 174b and / or the third stop 176a, 176b further comprises a bore 172a, 172b and a bore axis 210a, 210b. At least a portion of the bore 172a, 172b may further comprise a threaded bore. Alternatively, the bore 172a, 172b may comprise a first portion 208a, 208b and a second portion 208a’, 208b’. The first portion 208a, 208b of the bore 172a, 172b may match or substantially match the head of a fixation screw 100a, 100b. The second portion 208a’, 208b’ of the bore 172a, 172b may match or substantially match the shaft and / or threads of the fixation screw 100a, 100b. The second portion 208a’, 208b’ of the bore 172a, 172b may comprise threads. In another embodiment, the first portion 208a, 208b comprises a first diameter and the second portion 208a’, 208b’ comprises a second diameter. The first diameter is larger than the first diameter.
[0175] The bore 172a, 172b and / or the bore axis 210a, 210b may be positioned at an angle and / or at an oblique angle. The angle may comprise at least 20 degrees from the opening central axis 210 or greater. The angle may be within a range of 15 degrees to 25 degrees; within a range of 15 degrees to 20 degrees; within a range of 20 degrees to 25 degrees. In another embodiment, the angle of the bore 172a, 172b and / or the bore axis 210a, 210b may match or substantially match the sagittal pedicle angle 82 as referred to in FIG. 5D at one segment level. Alternatively, the angle of the bore 172a, 172b and / or the bore axis 210a, 210b may match or substantially match the sagittal pedicle angle 82 at a plurality of segment levels. Accordingly, the angle of the bore 172a, 172b and / or the bore axis 210a, 210b may be different at a plurality of spine segment levels.
[0176] In various embodiments, the inferior element 98a, 98b, the inferior base 216a, 216b, the inferior or lower articulating component 108a, 108b and / or the bridge 174a, 174b further comprises one or more materials. The materials may include metal, polymers and / or ceramics. The metals may comprise titanium, titanium alloys, cobalt-chrome alloys, platinum, stainless steel and / or any combination thereof. More specifically, the metal may include titanium and / or cobalt-chrome molybdenum (CoCrMo). The polymers may include thermoplastic or thermoset polymers. The polymers may further include carbon fiber, polyether ether ketone (PEEK), polyethylene (PE), ultra-high molecular weight polyethylene (UHMWPE), polycarbonate (PC), polypropylene (PP) and / or any combination thereof. The ceramics may include alumina ceramics, Zirconia (ZrO2) ceramics, Calcium phosphate or hydroxyapatite (Ca10(PO46(OH)2) ceramics, titanium dioxide (TiO2), silica (SiO2), Zinc Oxide (ZnO) and / or any combination thereof. The materials may be manufactured using traditional methods and / or using 3D printed techniques known in the art. Furthermore, the material may comprise a porous material, the porous material includes porous metal, porous polymer, porous ceramic and / or any combination thereof.
[0177] In another embodiment, the material may be further antioxidant stabilized. The stabilized antioxidants may comprise Vitamin E or Vitamin C. The antioxidants may be incorporated, diffused or doped into the material by blending the antioxidant into the material for subsequent cross-linking and / or diffusing the antioxidant into the material. The material may be further cross-linked before or after stabilizing with an antioxidant.
[0178] In various embodiments, each of the materials for each of the inferior element 98a, 98b, the inferior base 216a, 216b, the bridge 174a, 174b, and / or inferior or lower articulating component 108a, 108b may comprise a different material. In other embodiment, each of the materials for each of the inferior element 98a, 98b, the inferior base 216a, 216b, the bridge 174a, 174b and / or the inferior or lower articulating component 108a, 108b may comprise the same material.
[0179] In various embodiments, the bridge 174a, 174b and the inferior base 216a, 216b may comprise the same material or the material may be different. The bridge 174a, 174b and the inferior articulating component 108a, 108b may comprise the same material or the material may be different. The inferior base 216a, 216b and the inferior articulating component 108a, 108b may comprise the same material or the material may be different. The bridge 174a, 174b and the inferior base 216a, 216b may comprise the same material, but the inferior articulating component 108a, 108b comprises a different material than the bridge 174a, 174b and the inferior base 216a, 216b.
[0180] In various embodiments, at least one surface of the inferior element 98a, 98b, the inferior base 216a, 216b, the bridge 174a, 174b, the first stop 180a, 180b, the second stop 178a, 178b, the third stop 176a, 176b and / or the inferior or lower articulating component 108a, 108b may comprise a coating (not shown) and / or surface texture (not shown) to help facilitate healing, osseointegration, loading forces and / or wear. Alternatively, at least two or more surfaces of the inferior element 98a, 98b, the inferior base 216a, 216b, the bridge 174a, 174b, second stop 178a, 178b, the third stop 176a, 176b and / or the inferior or lower articulating component 108a, 108b comprises a coating and / or surface texture.
[0181] In various embodiments, at least a portion of the inferior articulating surface 228a, 228b or the inferior articulating component 108a, 108b comprises a coating and / or surface texture. At least a portion of the bridge 174a, 174b, the bridge top surfaces 206a, 206b, and / or the bridge bottom surface 204a, 204b may comprise a coating and / or surface texture. Accordingly, the coating and / or surface texture may be disposed onto at least one of the surfaces the inferior element 98a, 98b, the inferior base 216a, 216b, the bridge 174a, 174b and the inferior or lower articulating component 108a, 108b may comprise the same coating and / or surface texture and / or comprise a different coating and / or surface texture.
[0182] The surface textures or finishes may comprise threads, flutes, grooves, and / or teeth that may include various shapes. The various shapes may include tapered, stepped, conical and / or paralleled, flat, pointed, and / or rounded. The surface textures or finishes may further comprise roughened surfaces or porous surfaces, including turned, blasting, sand blasting, acid etching, chemical etching, dual acid etched, plasma sprayed, anodized surfaces, and / or any combination thereof. The surface textures or finishes may further include a polish surface finish or texture. The polished surface may be accomplished via different techniques, mechanical polishing, chemical polishing, electrolytic polishing, and / or any combination thereof. Polished surfaces can be measured in “Ra” micrometers (pm) or microinches ( / / in.).
[0183] The “Ra” may comprise a range of 0.025 to 1.60 pm; may comprise a range of 0.025 to 0.30 pm; may comprise a range of 0.025 to 0.20 pm; may comprise a range of 0.025 to 0.10 m; and / or may comprise a range of 0.05 to 0.20 pm. Accordingly, the Ra may comprise at least 0.05 pm or higher; at least 0.10 pm or higher and / or at least 0.8 pm or higher. Surface structure is often closely related to the friction and wear properties of a surface. A surface with a large Ra value will usually have somewhat higher friction and wear quickly, and a surface with a lower Ra value will have a lower friction and enhanced part performance and / or prevent or reduce unwanted adhesion of molecules or components to surface(s) (e.g., surfaces are smooth, shiny and less porous). Furthermore, a polished surface has many advantages,including improving cleanability, increases resistance to corrosion, reduces adhesive properties (for cells or other blood components to attach to), increases biocompatibility, increased light reflection for enhanced radiopacity, etc.
[0184] In one embodiment, the bridge 174a, 174b and the inferior base 216a, 216b comprise the same surface finish or texture, and the inferior articulating component 108a, 108b comprises a different surface finish or texture. The different surface texture or finish comprises a polished surface and the same surface texture or finish comprises a roughened surface texture. In another embodiment, the inferior base 216a, 216b comprises a first surface texture of finish, the bridge 174a, 174b comprises a second surface texture or finish, and the inferior articulating component 108a, 108b comprises a third surface texture or finish. The first surface texture and the second surface texture comprise the same surface texture. The third surface texture is different than the first and second surface texture.
[0185] In another embodiment, the top surfaces 206a, 206b of the bridge 174a, 174b comprise a first top surface texture and the bottom surface 204a, 204b of the bridge 174a, 174b comprises a first bottom surface texture. The bottom surface 218a, 218b of the inferior base 216a, 216b comprise a second bottom surface texture and the top surface 196a, 196b, 198a, 198b of the inferior base 216a, 216b comprise a second top surface texture. The first bottom surface texture is the same as the second bottom surface texture. The first top surface texture is the same as the second top surface texture. The first and second bottom surface texture is different than the first and second top surface texture. The first and second bottom surface texture comprises a roughened surface texture. The first and second top surface texture comprises a polish texture finish. The polish texture finish comprises at least an Ra of 0.8 or higher.
[0186] In various embodiments, at least a portion of the first contact surface 182a, 182b of the first stop 180a, 180b comprises a first surface texture, at least a portion of the second contact surface 188a, 188b of the second stop 178a, 178b comprises a second surface texture, and / or at least a portion of the inferior articulating component 108a, 108b comprises a third surface texture. The first and second surface texture may comprise the same surface texture or finish. The third surface texture or finish is different than the first and second surface texture or finish. The first surface texture or finish and the second texture or finish comprise polished surface finish. The third surface texture of finish comprises a polished surface finish. The polished surface finish of the third surface texture finish is higher or better than the polished surface finish of the first and second surface texture. Alternatively, the polished surface finish of the third surface texture finish is lower than the polished surface finish of the first and second surfacetexture. The polished surface finish of the third surface texture or finish comprises at least an Ra of 0.05 m or higher. The polished surface finish of the first and second surface texture or finish comprises at least an Ra of 0.10 jum or higher.
[0187] The coatings may include inorganic coatings or organic coatings. The coatings may further include a metal coating, a polymer coating, a composite coating (ceramic-ceramic, polymer-ceramic, metal-ceramic, metal-metal, polymer-metal, etc.), a ceramic coating, an antimicrobial coating, a growth factor coating, a protein coating, a peptide coating, an anti-coagulant coating, an antioxidant coating and / or any combination thereof. The antioxidant coatings may comprise naturally occurring or synthetic compounds. The natural occurring compounds comprises Vitamin E and Vitamin C (tocotrienols and tocopherols, in general), phenolic compounds and carotenoids. Synthetic antioxidant compounds include a-lipoic acid, N-acetyl cysteine, melatonin, gallic acid, captopril, taurine, catechin, and quercetin, and / or any combination thereof. The coatings can be impregnated, applied and / or deposited using a variety of coating techniques. These techniques include sintered coating, electrophoretic coating, electrochemical, plasma spray, laser deposition, flame spray, biomimetic deposition and wet methods such as sol-gel-based spin- and -dip or spray-coating deposition have been used most often for coating implants.
[0188] The metal coatings may comprise titanium, titanium alloys, cobalt-chrome alloys, platinum and stainless steel, and / or any combination thereof. More specifically, the metal coating includes titanium and / or cobalt-chrome molybdenum (CoCrMo). The polymer coatings may include thermoplastic or thermoset polymers. The polymers may further include carbon fiber, polyether ether ketone (PEEK), polyethylene (PE), ultra-high molecular weight polyethylene (UHMWPE), polycarbonate (PC), polypropylene (PP) and / or any combination thereof. The ceramic coatings may include alumina ceramics, Zirconia (ZrO2) ceramics, Calcium phosphate or hydroxyapatite (Ca10(PO46(OH)2) ceramics, titanium dioxide (TiO2), silica (SiO2), Zinc Oxide (ZnO) and / or any combination thereof. The materials may be manufactured using traditional methods and / or using 3D printed techniques known in the art. Furthermore, the material may comprise a porous material, the porous material includes porous metal, porous polymer, porous ceramic and / or any combination thereof.
[0189] In various embodiments, the bridge 174a, 174b and the inferior base 216a, 216b may comprise the same coating, and the inferior articulating component 108a, 108b may comprise a different coating. In another embodiment, the bridge 174a, 174b, the inferior base 216a, 216b and the inferior articulating component 108a, 108b may comprise the same coating. The same coating may comprise a metallic coating and the different coating may comprise a polymericcoating. In another embodiment, the inferior base 216a, 216b may comprise a first coating, the bridge 174a, 174b comprises a second coating, and the inferior articulating component 108a, 108b comprises a third coating. The first coating and the second coating may comprise the same coating. The third coating may be different than the first and second coating. The first and second coatings may comprise a metal coating such as Titanium. The third coating may comprise a metal coating such as cobalt-chrome molybdenum (CoCrMo). In another embodiment, the top surfaces 206a, 206b of the bridge 174a, 174b may comprise a first coating and the bottom surface 204a, 204b of the bridge 188 may comprise a second coating. The first coating may be the same or different as the second coating.
[0190] In another embodiment, at least a portion of the first contact surface 182a, 182b of the first stop 180a, 180b comprises a first coating, at least a portion of the second contact surface 188a, 188b of the second stop 178a, 178b comprises a second coating, and / or at least a portion of the inferior articulating component 108a, 108b comprises a coating. The first and second coating may comprise the same coating. The third coating is different or the same as the first and second coating. The first coating and the second coating comprises a titanium coating. The third coating may optionally comprise no coating.
[0191] With reference to FIGS. 18A-18C, the inferior or lower element 98a, 98b may comprise different total inferior element lengths 200a, 200b to accommodate different vertebral body sizes. The total inferior element lengths 200a, 200b may comprise generic lengths such as small, medium, large, extra-large. Alternatively, the total inferior element lengths 200a, 200b may be offered in a range of 20 mm to 60 mm; a range of 20 mm to 40 mm; a range of 40 to 60 mm; and / or a range of 45 mm to 55 mm. The total inferior element lengths 200a, 200b ranges may be incremental by 1 mm, 2 mm, 3 mm, 4 mm, or 5 mm; the inferior element lengths 200a, 200b ranges may be incremental by 3 mm or greater. The inferior or lower element 98a, 98b is solid.
[0192] In various embodiments, the total joint or dynamic spinal implant 94a, 94b may further comprise a fixation screw 100a, 100b. The fixation screw 100a, 100b comprises a head 238a, 238b, a shaft 242a, 242b, threads 240a, 240b, a tip 243a, 243b and a screw total length 248a, 248b. The shaft 242a, 242b comprises a minor diameter or shaft diameter 241a, 241b. The threads 240a, 240b comprises a major diameter or thread diameter 245a and a pitch 247a, 247b. At least a portion of the screw 100a, 100b is designed and configured to be disposed into the bore 172a, 172b of the inferior element 98a, 98b. Alternatively, the screw 100a, 100b is designed and configured to be disposed into the bore 172a, 172b. The fixation screw shaft 242a, 242b and threads 240a, 240b are solid. Alternatively, the fixation screw shaft 242a, 242band threads 240a, 240b may be hollow to allow guidewires or cannulas through the cannula opening (not shown).
[0193] In one embodiment, the head 238a, 238b is sized and configured to fit or be disposed within the first portion 208a, 208b of the bore 172a, 172a of the inferior element 98a, 98b. The shaft 242a, 242b and the threads 240a, 240b is sized and configured to be disposed within the second portion 208a’, 208b’ of the bore 172a, 172b. The head 238a, 238b comprises a top surface 246a, 246b and a driving style or drive recess 244a, 244b. The head 238a, 238b comprises at least one selected from a hex head, a pan head, a flat head, a round head, an oval head, a truss head, a socket head, a button head, a fillister head, an indented head, and / or any combination thereof. The drive recess 244a, 244b may comprise a Phillips, a Frearson, a Posidrive, a Slotted, a Combo, a Hex Socket, a Square, a Torx, a Supadriv, a Spanner, hexalobular and / or any combination thereof. The drive recess 244a, 244b extends from the top surface towards the shaft 242a, 242b. The drive recess 244a, 244b is sized and configured to receive a driving tool (not shown).
[0194] At least a portion of the top surface 246a, 246a of the head 238a, 238b contacts a portion of the retainer clip 102a, 102b. At least a portion of the top surface 246a, 246b contacts a portion of the flanges 256a, 256b of the retainer clip 102a, 102b. Alternatively, at least a portion of the top surface 246a, 246b contacts a flange surface 260a, 260b of the flanges 256a, 256b of the retainer clip 102a, 102b. Furthermore, at least a portion of the top surface 246a, 246b of the head 238a, 238b sits or positioned equal to the contact surface 252a, 252b of the bore 172a, 172b of the inferior element 98a, 98b. At least a portion of the top surface 246a, 246b sits or is positioned below the contact surface 252a, 252b of the opening 172a, 172b of the inferior element 98a, 98b.
[0195] The fixation screw 100a, 100b comprises a total screw length 248a, 248b. The total screw length 248a, 248b may match or substantially match pedicle length 73 as shown in FIG. 5B. The total screw length 248a, 248b may comprise a range of 30 mm to 60 mm; a range of 30mm to 50 mm; a range of 30 mm to 40 mm; a range of 35 mm to 45 mm; and / or any combination thereof. The total screw length 248a, 248b may be sufficient to engage with cortical bone, cancellous bone, and / or cortical and cancellous bone.
[0196] The fixation screw 100a, 100b further comprises threads 240a, 240b. The threads 240a, 240b may comprise a single lead or multiple lead or multi-start threads. In one embodiment, the threads 240a, 240b may comprise a double-lead, a triple-lead and / or a quad-lead threads. The threads 240a, 240b may further comprise a pitch 247a, 247b. The pitch 247a, 247b may comprise a fine or coarse pitch. In one embodiment, the pitch 247a, 247b comprises a coarsepitch. The coarse pitch is designed to anchor into the softer, spongy bone. The fine pitch is designed cortical bone because the bone is denser, and the torque may be high. In one embodiment, the pitch 247a, 247b may comprise a range of 2 mm to 5 mm; may comprise a range of 3 mm to 5 mm; may comprise a range of 3 mm to 4 mm; and / or may comprise a range of 3 mm to 3.5 mm. Alternatively, the pitch may comprise at least 2.5 mm or greater; may comprise at least 3.0 mm or greater; may comprise at least 3.20 mm or greater; it may comprise at least 3.5 mm or greater; it may comprise at least 4 mm or greater. The threads 240a, 240b may comprise a clockwise or counterclockwise rotation.
[0197] In one embodiment, the threads 240a, 240b may comprise a thread diameter or major diameter 245a, 245b. The thread diameter 245a, 245b may comprise a small, medium or large diameter. Large diameter threads and higher or coarser pitch offers a greater surface area for the purchase of the threads 240a, 240b on the cancellous bone. Furthermore, large diameter threads increase the pull-out strength or pull-out resistance - the large diameter threads form companion or complementary threads in the bone by compression as well as by deforming the bone trabeculae. The spring or elastic reaction occurs as the cancellous bone is deformed during the thread forming procedure resulting in the compressed companion threads of the cancellous bone to contact the larger surface area of the threads 240a, 240b. Alternatively, smaller diameter threads and finer or lower pitch also increases holding power or pull-out strength of the fixation screw. More turns may be completed to engage to a given depth into the bone - the more threads engage, the greater the pull-out resistance. The smaller diameter threads cut into bone while it is inserted cause an elastic reaction of the bone to grip the bone surfaces together - causing elastic deformation of the bone. The bone deforms and offers an elastic binding force.
[0198] In another embodiment, the thread diameter 245a, 245b may comprise a range of 3 mm to 10 mm; may comprise a range of 3 mm to 8 mm; may comprise a range of 3 mm to 6 mm; and / or may comprise a range of 4 mm to 5 mm. Accordingly, the thread diameter 245a, 245b may comprise at least 3.5 mm or greater; may comprise at least 4 mm or greater; may comprise at least 4.5 mm or greater; and / or may comprise at least 5 mm or greater. Alternatively, the thread diameter 245a, 245b and / or the threads 240a, 240b may match or substantially match the pedicle width 80 as shown in FIG. 5D.
[0199] In various embodiments, the threads 240a, 240b of the fixation screw 100a, 100b may comprise different thread forms. The thread forms may comprise V-thread, buttress, unified, metric, square, ACME, helical and / or any combination thereof. The helical threads allow the user to transform smaller radial movement into large axial movement. In one embodiment, thethread form of the threads comprises a helical thread form. In another embodiment, the fixation screw 100a, 100b may comprise different screw tips or points to properly cut and affix to different bone types. More specifically, the threads 240a, 240b may include threads known in the art that can properly cut and affix to cancellous and / or cortical bone.
[0200] In various embodiments, the threads 240a, 240b may comprise one or more thread angles 249a, 249b, 251a, 251b. Each of the one or more thread angles 249a, 249b, 251a, 251b may comprise the same angles. Each of the one or more thread angles 249a, 249b, 251a, 251 b may comprise different angles. Alternatively, the threads 240a, 240b may comprise a first thread angle 249a, 249b and a second thread angle 251a, 251 b. The first thread angle 249a, 249b and the second thread angle 251a, 251 b may comprise the same angle. The first thread angle 249a, 249b and the second thread angle 251a, 251b may comprise a different angle. The thread angles 249a, 249b, 251a, 251b may comprise a range of 60 degrees to 120 degrees; may comprise a range of 70 degrees to 120 degrees; may comprise a range of 80 degrees to 120 degrees; and / or may comprise a range of 85 degrees to 120 degrees. Accordingly, the first thread angle 249a, 249b may comprise at least 75 degrees or greater; may comprise at least 80 degrees or greater; and / or may comprise at least 85 degrees or greater. The second thread angle 251a, 251 b may comprise at least 105 degrees or greater; it may comprise at least 110 degrees or greater; and / or it may comprise at least 115 degrees or greater.
[0201] In various embodiments, the fixation screw shaft 242a may comprise a minor diameter 241a, 241 b. The minor diameter 241a, 241b may be uniform or non-uniform. The minor diameter 241a, 241 b may be tapered. The minor diameter 241a, 241 b may be tapered along the screw length 248a, 248b. The minor diameter 241a, 241 b may be tapered along a portion of the screw length 248a, 248b. Alternatively, at least a portion of the minor diameter 241a, 241b may be tapered along a portion of the screw length 248a, 248b. The tapering comprises a taper angle, the taper angle may comprise at least 5 degrees to 10 degrees; may comprise at least 7 degrees to 10 degrees; may comprise at least 8 degrees to 10 degrees; and / or may comprise at least 8 degrees to 9 degrees. Accordingly, the taper angle may be at least 5 degrees or greater; the taper angle may be at least 7 degrees or greater; the taper angle may be at least 8 degrees or greater; the taper angle may be at least 8.5 degrees or greater; and / or the taper angle may be at least 10 degrees or greater or 10 degrees or less. In another embodiment, the minor diameter 241a, 241b may comprise a diameter of 1.5 mm or greater; it may comprise a diameter of 2.0 mm or greater; it may comprise a diameter of 2.25 mm or greater; and / or it may comprise a diameter of 2.5 mm or greater and / or 2.5 mm or less.
[0202] In another embodiment, the fixation screw 100a, 100b comprises a tip 243a, 243b. The screw points or tips 243a, 243b may comprise self-drilling, self-piercing, self-tapping, and / or a combination thereof. The long, sharp screw points or tips would desirably help eliminate hole preparation (no punching, pre-drilling or tapping required) and / or help penetrate the bone quicker or quickly and / or capture bone chips or bone debris for increasing local bone density and / or increase the bone’s ability to withstand “back out” pressure (e.g., less loosening or migration).
[0203] The fixation screw 100a, 100b may comprise a material, which may include metal, polymers or ceramic. The metals may comprise titanium, titanium alloys, cobalt-chrome alloys, platinum, stainless steel and / or any combination thereof. More specifically, the metal may include titanium and / or cobalt-chrome molybdenum (CoCrMo). The polymers may include thermoplastic or thermoset polymers. The polymers may further include carbon fiber, polyether ether ketone (PEEK), polyethylene (PE), ultra-high molecular weight polyethylene (UHMWPE), polycarbonate (PC), polypropylene (PP) and / or any combination thereof. The ceramics may include alumina ceramics, Zirconia (ZrO2) ceramics, Calcium phosphate or hydroxyapatite (Ca10(PO46(OH)2) ceramics, titanium dioxide (TiO2), silica (SiO2), Zinc Oxide (ZnO) and / or any combination thereof. The materials may be manufactured using traditional methods and / or using 3D printed techniques known in the art. Furthermore, the material may comprise a porous material, the porous material includes porous metal, porous polymer, porous ceramic and / or any combination thereof. The fixation screw 100a, 100b may be solid or the fixation screw 100a, 100b may be cannulated or hollow.
[0204] In various embodiments, the total joint or dynamic spinal implant 94a, 94b further comprises a retainer clip 102a, 102b. The retainer clip 102a, 102b may be disposed into to the recessed clip channel 202a, 202b to help prevent migration of the fixation screw 100a, 100b after deployment and / or securement to the bone. At least a portion of the retainer clip 102a, 102b is movable from a first position to a second position, the first position being moved axially away from the central axis 262 while the fixation screw 102a, 102b is being secured to the bone, and the second position that allows the retainer clip to return to rest once the head 238a, 238b of the fixation screw 102a, 102b is below the at least one flange 256a, 256b.
[0205] The retainer clip 102a, 102b may comprise a body 254a, 254b and at least one flange 256a, 256a’, 256b, 256b’. The body 254a, 254b of the retainer clip 102a, 102b comprises a shape, the shape includes a “U” shape. Alternatively, the body 254a, 254b comprises a first arm and a second arm. The body 254a, 254b comprises a first end 264a, 264b and a second end 266a, 266b. The at least one flange 256a, 256a’, 256b, 256b’ are disposed at the second end266a, 266b of the body 254a, 254b of the retainer clip 102a, 102b. The at least one flange 256a, 256a’, 256b, 256b’ extends away from the second end 266a, 266b of the body 254a, 254b of the retainer clip 102a, 102b. Alternatively, the at least one flange 256a, 256a’, 256b, 256b’ extends inwardly towards a central axis 262 of the retainer clip 102a, 102b. The at least one flange 256a, 256a’, 256b, 256b’ extends perpendicularly from the second end 266a, 266b of the body 254a, 266b of the retainer clip. The at least one flange 256a, 256a’, 256b, 256b’ extends from the second end 266a, 266b of the body perpendicularly toward the central axis 262.
[0206] In various embodiments, the retainer clip 102a, 102b comprises a body 254a, 254b, a first flange 256a, 256b and a second flange 256a’, 256b’. The body 254a, 254b comprises a first arm and a second arm. The body 254a, 254b and / or each of the first arm and second arm of the body 254a, 254b comprises a first end 264a, 264b and a second end 266a, 266b. The first flange 256a, 256b is disposed at the second end of the first arm of the body 254a, 254b. The second flange 256a’, 256b’ is disposed at the second end 266a, 266b of the second arm of the body 254a, 254b. The first flange 256a, 256b extends away from the second end 266a, 266b the first arm of the body 254a, 254b of the retainer clip 102a, 102b. The second flange 256a’, 256b’ extends away from the second end 266a, 266b the second arm of the body 254a, 254b of the retainer clip 102a, 102b. Alternatively, the first flange 256a, 256b and the second flange 256a’, 256b’ extends inwardly towards the central axis 262 of the retainer clip 102a, 102b. The first flange 256a, 256b extends perpendicularly from the second end 266a, 266b of the first arm of the body 254a, 254b of the retainer clip 102a, 102b. The second flange 256a’, 256b’ extends perpendicularly from the second end 266a, 266b of the second arm of the body 254a, 254b of the retainer clip 102a, 102b. The first flange 256a, 256b extends from the second end 266a, 266b of the first arm of the body 254a, 254b perpendicularly toward the central axis 262.
[0207] The body 254a, 254b can be sized and configured to be disposed and / or positioned into the recessed clip channel 202a, 202b. The body 254a, 254b may comprise a clip width 258a, 258b, the clip width 258a, 258b may match or substantially match a width of the recessed clip channel 202a, 202b. The at least one flange 256a, 256a’, 256b, 256b’, the first flange 256a, 256b, and / or the second flange 256a’, 256b’ extend into the opening 172a, 172b of the inferior element 98a, 98b. Alternatively, at least a portion of the at least one flange 256a, 256a’, 256b, 256b’ extend into a portion of the opening 172a, 172b of the inferior element 98a, 98b. The at least one flange 256a, 256a’, 256b, 256b’ comprises a flange surface 260a, 260a’, 260b, 260b’. Alternatively, the first flange 256a, 256b comprises a first flange surface 260a, 260b. Thesecond flange 256a’, 256b’ comprises a second flange surface 260a’, 260b’. The flange surface 260a, 260a’, 260b, 260b’, the first flange surface 260a, 260b and / or the second flange surface 260a’, 260b’ faces towards the top head surface 246a, 246b of the fixation screw 100a, 100b. At least a portion of the top head surface 246a, 246b contacts a portion of the at least one flange surface 260a, 260a’, 260b, 260b’, the first flange surface 260a, 260b, and / or the second flange surface 260a’, 260b’ of the flanges 256a, 256a’, 256b, 256b’ of the retainer clip 102a, 102b. The at least one flange 256a, 256a’, 256b, 256b’, the first flange 256a, 256b and / or the second flange 256a’, 256b’ further comprises rounded or radiused edges 268a, 268a’, 268b, 268b’ to facilitate easier insertion of the fixation screw 102a, 102b. Accordingly, at least a portion of the body 254a, 254b may comprise filleted or beveled edges and / or at least a portion of the body 254a, 254b may comprise filleted or beveled edges surrounding the perimeter.
[0208] The retainer clip 102a, 102b may comprise a material including metal, polymers or ceramic. The metals may comprise titanium, titanium alloys, cobalt-chrome alloys, platinum, stainless steel and / or any combination thereof. More specifically, the metal may include titanium and / or cobalt-chrome molybdenum (CoCrMo). The polymers may include thermoplastic or thermoset polymers. The polymers may further include carbon fiber, polyether ether ketone (PEEK), polyethylene (PE), ultra-high molecular weight polyethylene (UHMWPE), polycarbonate (PC), polypropylene (PP) and / or any combination thereof. The ceramics may include alumina ceramics, Zirconia (ZrO2) ceramics, Calcium phosphate or hydroxyapatite (Ca10(PO46(OH)2) ceramics, titanium dioxide (TiO2), silica (SiO2), Zinc Oxide (ZnO) and / or any combination thereof. The retainer clip 102a, 102b may be solid and / or the retainer clip 102a, 102b may be hollow. The materials may be manufactured using traditional methods and / or using 3D printed techniques known in the art. Furthermore, the material may comprise a porous material, the porous material includes porous metal, porous polymer, porous ceramic and / or any combination thereof.
[0209] Exemplary Implantation Procedure
[0210] The disclosed surgical procedure and the spinal implant 94a, 94b may be desirably used as a total joint replacement resulting in sagittal and / or coronal alignment by creating more lordosis and / or more kyphosis during the surgical procedure. As shown in FIGS. 3A-3C and 4, all patients or people typically have a natural lumbar lordotic angular variance across various spinal levels within the different spine regions. The spine’s natural lordotic and kyphotic curvatures and its angular variance are designed for even distribution of weight and flexibility of movement. These natural curves work in harmony to keep the body’s center of gravity aligned over the hips and pelvis - i.e., keeps our head over our pelvis and hips. However, degenerateddiscs 42 and / or facets can adversely affect the structural integrity of the spine and contribute to scoliosis 38 (FIG. 3A) and / or lordosis or kyphosis 40 (FIG. 3B) as well as other curvature disorders such as scoliosis. Any exaggeration or abnormalities of the curves in the sagittal plane or coronal plane, results in sagittal imbalance or coronal imbalance. Thus, maintaining a mechanical balance within the sagittal plane and coronal plane would help facilitate equilibrium of the spine and body with minimum energy expenditure or reduction of stresses to other regions of the spine. It is desirable to restore the spine to adequate or optimal coronal and / or sagittal alignment as a primary surgical strategy to prevent adjacent segment disease and / or changes of load on different structures within the spine.
[0211] One or more spinal implants 94a, 94b can be deployed utilizing different surgical spinal stabilization approaches into one or more spinal functional units or spinal segments in one or more spinal regions. The one or more dynamic spinal implants 94a, 94b can be deployed using a posterior approach. The one or more dynamic spinal implants can be deployed using an anterior approach and / or a transverse approach. Furthermore, a discectomy, laminectomy and / or other procedures may be necessary. Traditional methods may be used to access the one or more spinal segments. However, the use of robotics and / or computer guided surgical platforms (and / or computer-aided navigation) are contemplated herein, including in the planning and / or execution stages of the surgery.
[0212] FIGS. 28A-28B, 29A-29D, 30A-30D depicts a side view or sagittal view of an exemplary spinal motion unit that is undergoing a surgical procedure in accordance with one exemplary embodiment of the spinal implant 94a, 94b. In this embodiment, preoperative image data of the spinal motion unit has been obtained, and a preoperative surgical plan to alter the coronal and / or sagittal alignment of the spinal motion is proposed.
[0213] During the preoperative surgical planning, a proposed implant size, orientation (toe-in angle and / or coronal angle) and / or a proposed amount of correction for the spinal implant 94a, 94b to correct coronal and / or sagittal deformities may be presented. In some embodiments, the proposed amount of correction or proposed orientation of the spinal implant 94a, 94b may comprise a new alignment path or resection plane 284 that may be different than the anatomical or endplate plane 282 currently in the patient. The new or revised alignment path or resection plane 284 may require the surgical removal of at least a portion of the intervertebral disc and / or bony material from the lower vertebral body 18 in a right side, a left side, and / or right and left sides at one or both pedicles, which is represented within FIGS. 29A-29D and 30A-30D (involving removal of bony material at or below the anatomical alignment line or anatomical plane 282 up to the revised alignment line, plane or resected plane 284. In variousembodiments, this surgical procedure might allow some and / or all of at least a portion of the pedicles to be preserved during such removal, such that the remaining portions of the pedicle remain attached to the vertebral body and are capable of providing additional support and stability to portions of the spinal implant 94a, 94b.
[0214] The revised alignment line, plane or resected plane 284 may be flat, planar, or comprise no angle. The revised alignment line, plane or resection plane 284 may be at and / or below the anatomical plane 282. The revised alignment line, plane or resected plane 284 may comprise an angle, the angle being oriented relative to the anatomical line or plane 282. The revised alignment line, plane or resection plane 284 will desirably define the new orientation of the dynamic spinal implant 94a, 94b with respect to the upper vertebra 12 and the lower vertebra 18. If desired, the revised alignment line or resected plane 284 may be symmetrical on right and / or left sides of the vertebral body, or the resection may be asymmetrical in some fashion (i.e. , differing depths, endplate angulations, toe in angles, etc.).
[0215] Different sizes of the spinal implant 94a, 94b may be contemplated as described within FIGS. 11A-11 E, 12A-12C, 18A-18C and FIG. 25. The desired size of the spinal implant 94a, 94b may depend on several factors including surgical approach, intended spinal segment region (e.g., thoracic or lumbar), patient anatomy, degree of degeneration, and amount of alignment or correction required. As described herein and within FIG. 25, the total joint or dynamic spinal implant 94a, 94b may include different lengths and different heights. The different lengths may include short, medium, and / or long. The specific lengths may be available in 11 mm to 15 mm, with 1 mm increment change in length. Furthermore, the dynamic spinal implant 94a, 94b may be available in different heights 120. The height 120 of the dynamic spinal implant may include at least 5 mm to 15 mm; the height 120 may include at least 5 mm to 12 mm; and / or the height 120 may include at least 7 mm to 12 mm. Alternatively, the height 120 may include at least 7.5 mm. Each of the heights are available for each of the lengths to produce approximately 15 or greater different combinations.
[0216] OFFSET VERTEBRAL BODIES AND MOTION IMPLANTS
[0217] Spondylolisthesis is condition where a vertebra has slipped out of place, and is generally resting on the bone below it. Vertebrae may slip out of place due to a degenerative condition, or spondylolysis (e.g., a stress fracture or crack in the bones of the spine) may cause spondylolisthesis when a stress fracture causes the slipping. The disks between vertebrae and the facet joints can also wear down, allowing spondylolisthesis to occur. Spondylolisthesis is typically graded based on the degree of slippage (Meyerding Classification) of one vertebral body on the adjacent vertebral body, from grade 1 (e.g., less than a 25% slippage - whichtypically does not require surgical intervention) to grade 4 (e.g., greater than a 75% slippage - which typically causes pain and requires intervention). Spondylolisthesis is a leading cause of disability and paralysis in persons over the age of 50. Vertebral slippage in degenerative spondylolisthesis can happen symmetrically or asymmetrically.
[0218] In the past, surgeons traditionally recommended decompression, stabilization and spinal fusion for spondylolisthesis having instability and / or which causes pain or other symptoms (and which has failed conservative therapy). Spinal fusion sought to stabilize the spine by permanently joining the two vertebrae, eliminating movement and / or further slippage from occurring between them. Typically, bone grafts were placed between vertebrae to help them fuse together, and some procedures included the use of metal screws and rods to hold and / or stabilize the vertebrae together while they healed and fused. More recently, spinal motion implants have been designed which desirably retain motion of the treatment levels while alleviating pain and / or other symptoms.
[0219] One significant difficulty with treating spondylolisthesis is the significant displacement between the upper and lower vertebral bodies of the level to be treated. Unlike a normal spinal level where the vertebra are generally in an elongated column, a spinal level experiencing spondylolisthesis will have the upper vertebrae offset from the lower vertebra. Spondylolisthesis most commonly occurs in the lumbar spine, primarily at the L5-S1 level, with the L5 vertebral body anteriorly translating over the S1 vertebral body. Where enough slippage has occurred between two levels, it can be difficult for an implant to stabilize the injured levels and / or prevent further slippage from occurring.
[0220] FIGS. 34A through 40G depict various views of spinal motion implant embodiments particularly well suited for treating spinal levels where a significant amount of spondylolisthesis, vertebral slippage and / or other spinal offset(s) may have occurred. Because many of the features of these embodiments are similar to those of the embodiments of FIGS. 7A-7H, 8A-8D and 9A-9B, like reference numerals have been used to describe various components having like and / or similar functions and / or construction, and the descriptions and disclosures relating to those parts should apply equally to these components unless otherwise noted to the contrary.
[0221] FIGS. 33A and 33B depict side views of a spinal level having offset or “slipped” adjacent vertebral bodies, which is commonly referred to as spondylolisthesis. Spondylolisthesis is a condition that occurs when one vertebral body slips with respect to the adjacent vertebral body. Spondylolisthesis is very common in older individuals (e.g., degenerative spondylolisthesis), and typically occurs in the L4-L5 segment, which is the one in the lumbar spine with the most movement, and is thus most likely to slip when this process occurs), although the next mostcommon levels affected by degenerative spondylolisthesis are L3-L4 and L5-S1. Isthmic spondylolisthesis occurs most often at L5-S1 , and is more often seen in younger adults than degenerative spondylolisthesis. The cause is a defect in an important bridge bone (the pars interarticularis) of L5.
[0222] Spondylolisthesis can commonly be classified into one of 5 groups (per Newman, 1976), Group 1 : dysplastic, Group 2: isthmic, Group 3: traumatic, Group 4: degenerative and Group 5: pathological. These groups correspond to the degree of slippage between the adjacent vertebral level, such as Grade 5 slip (>100% slip or Spondyloptosis), Grade 4: 75-100% slip, Grade 3: 50-75% slip, Grade 2: 25-50% slip, or Grade 1 : <25% slip.
[0223] In the lower grades, many patients with spondylolysis and spondylolisthesis will not have any obvious symptoms, but as vertebral “slips” progressively occurs during their lives, the patient may experience mild to moderate back pain, discomfort and / or mobility limitations as their soft tissues and / or weakened bones stabilize into the new “slipped” position. Eventually, enough slippage can occur to cause (1) the facet joints to enlarge and place pressure on the nerve root (e.g., causing lumbar spinal stenosis and lateral recess stenosis), and / or (2) narrowing of the intervertebral foramen can occur (e.g., foraminal stenosis, where severe nerve compression can occur with accompanying pain, numbness and weakness in the legs, as well as possible loss of control of the bladder and / or bowels).
[0224] Once surgical intervention is recommended, which often occurs at Grade 3 or higher (but might be required at lower grades for a variety of reasons), it may be difficult, impossible and / or undesirable to attempt to reduce and / or correct the slippage amount between the vertebrae. For example, the soft tissues surrounding the treated level may have stabilized at a slipped position, and they can significantly resist and / or prevent surgical reduction of the degree of slippage during surgery. Similar, attempts to correct the slipped vertebra using surgical tools and instrumentation may damage the vertebral bodies, overstress soft tissues and / or destabilize the treated level or other spinal structures to an unwanted degree. In many cases, a surgical intervention that stabilizes the vertebral level in its current slipped position, or one which reduces such slippage to some limited degree (but the level remains “less than perfect”) may provide an optimal solution for the patient.
[0225] FIGS. 34A-34G disclose spinal motion implant that are particularly well suited for use in spondylolisthetic, slipped and / or offset vertebral levels. As best seen in FIGS. 33A and 33B, such an implant can easily be positioned between offset vertebral levels, which will restore motion to the offset level and also desirably reduce and / or eliminate the further spondylolisthetic progression of the treated level. Such an implant design allows for partial and / or completeremoval of the posterior lamina as well as the inferior and / or superior facets, which are the primary causes of nerve impingement and / or pain), while restoring spinal motion and stability via the various articulating surfaces and anterior and posterior stops, bumpers and / or motion limiters of the implant components.
[0226] FIG. 34A through 40G depict one exemplary embodiment of a spinal motion implant 94c for use with slipped or offset levels. In this embodiment, a superior component 96c may include a superior base comprising a first end or anterior end, a second end or posterior end, a third end or medial end and / or a fourth end or lateral end. The superior base may further comprise a first top surface 116c, a second top surface 117, a bottom surface 138c, and / or a domed surface 140c. The superior base further may comprise a flange 132c, a first posterior wall or posterior tab 112c and an optional second posterior wall or tab 112c’. The second posterior wall or tab 112c’ (or other structure of the implant) may be spaced apart from the first posterior wall or tab 112c at a set distance. The set distance may comprise a series of implant having different spacings such as 2 mm to 10 mm; the set distance may comprise 3 mm to 8 mm; the set distance may comprise 3 mm to 6 mm; and / or the set distance may comprise at least 3 mm or greater. In various embodiments, the disclosed devices can be utilized to treat patients with spondylolisthesis, and if desired, the distance between the posterior end of the superior implant and posterior end of the superior implant keel can be altered to facilitate different degrees of spondylolisthesis.
[0227] In some embodiments, at least a portion of the top surfaces 116c, 117 of the superior base 110c may be flat or planar. In other embodiments, at least a portion of one or both of the top surfaces 116c, 117 may be curved, angled, sloped, irregularly shaped or and / or not flat or planar. In another embodiment, at least a portion of one of the top surfaces 116c, 117 is flat or planar while another portion of the other top surface is curved, sloped or angled. The angle or sloping may comprise a downward slope or angle. The slope or angle may comprise an angle of 10 degrees to 20 degrees; an angle of 12 degrees to 18 degrees; and / or an angle of 14 degrees to 16 degrees. The angled top surface portion may be positioned at an anterior end 124 of the superior base 110c. An angled top surface portion may extend along portion(s) of the medial and / or the lateral ends of the base. The angled top surface portion may be positioned at one or more locations. The angled surface and / or any curving thereof may include an arch, concave or convex shapes.
[0228] At least a portion of the top surface 116c will desirably contact the vertebra bone, such as where at least a portion of the top surface 116c contacts the endplate of the upper vertebra. In this embodiment, at least a portion of the top surface 117 will typically not contact thevertebra bone and / or the endplate, as some portion of the base will be typically extending posteriorly and / or outside the disc space. The superior base 110c includes a first posterior wall or posterior tab 112c and further comprises a second posterior wall or tab 112c’. The second posterior wall or tab 112c’ is positioned on the second or posterior end of the superior base 110c. The second posterior wall 112c’ may include an anterior facing surface 142c’ and a posterior facing surface 144c’ that may be flat, planar and / or any other shape. The second posterior wall or tab 112c’ may include an anterior facing surface 142c’ and a posterior facing wall 144c’. If desired, the second posterior wall 112c’ may extend upwardly from the top surface 117 of the superior base 110c. When properly positioned with an intervertebral space, at least a portion of the anterior facing surface of the first posterior wall or tab 112c will contact bony structures such as a posterior facing surface of the vertebra and / or the inferior vertebral rim of the upper vertebra. Concurrently, at least a portion of the second posterior wall 112c’ can be positioned posterior of the disc space, where it typically would not contact portions of the upper vertebral body and / or or endplate, while desirably remaining clear of nerves, the spinal cord, blood vessels and / or other anatomical structures.
[0229] While not expressly depicted herein, an additional embodiment of a spinal motion implant for use with slipped or offset levels might incorporate an offset inferior component, wherein the ball and stops have been shifted closer to the fixation screw of the implant (e.g. shifted posteriorly on the base, in a manner similar to the above spondylolisthesis implant component), which inferior implant might be utilized with a standard superior component such as depicted in FIGS. 7A through 15N. Such an implant may be particularly useful for treating spinal levels suffering from retrolisthesis or similar conditions.
[0230] FIGS. 41 A and 41 B depict views of another exemplary embodiment of a lower or inferior element 98d, which can be utilized in combination with various system components described herein. In this embodiment, the inferior element includes a bridge 174d which includes a lower tab 400 positioned at a posterior end of the bridge 174d. The lower tab 400 desirably extends downwardly from the bridge 174d, with at least a portion of the lower tab extending below the bottom surface 204d, such that the tab 400 can present an engagement surface 4110 which is substantially perpendicular to the bottom surface 204d (although in other embodiments the engagement surface 4110 may be positioned at differing angles with respect to the bottom surface). In use, the inferior element can desirably be positioned on a resected vertebral surface with the bottom surface 204d engaged with a resected pedicle surface, and the tab and engagement surface 4110 positioned against a posterior ledge of the resected pedicle surface or similar bony surface (not shown), such that undesired anterior migration or sliding of theinferior element is prevented and / or restricted (in a manner similar to the posterior tab of the superior element herein). Such a construct may be particularly useful for treating offset vertebral levels (e.g., slipped or spondylolisthesis levels), as the implant components may be subject to increased anterior loading as compared to a non-offset level. FIG. 42 depicts the inferior element of FIGS 41 A and 41 B with a corresponding superior element.
[0231] FIGS. 43A through 43E depict various views of one exemplary embodiment of an inferior buttress plate 4300, which can be utilized in combination with various system components described herein. In this embodiment, the buttress plate 4300 includes a central member 4310, an attachment prong 4320 and a lower fixation opening 4330. The plate 4300 can optionally include one or more openings or slots 4340, which may reduce x-ray artifacts caused by the plate in various orientations.
[0232] The buttress plate 4300 can desirably be utilized if a surgeon prefers a different fixation screw placement and / or angle than that provided by the fixation bore of the bridge element, as well as where the surgeon may desire to further inhibit anterior migration and / or movement of the inferior component. The buttress plate can permit a rescue screw to be utilized (e.g., where a screw can be inserted through an inferior thru-hole containing stripped bone). If desired, the hole in the buttress plate may be of differing or the same sizes and / or angulations as the fixation bore of the bridge element. In addition, the altered loading of an implant construct for patients with offset levels and / or spondylolisthesis may cause the superior implant to “pull” the inferior implant anteriorly after implantation, which can be addressed by using a more robust posterior fixation method to resist motion in that direction.
[0233] In use, the attachment prong 4320 of the buttress plate 4300 can desirably be inserted into a fixation bore 172d (similarly, 172a, 172b and / or 172c) of an inferior component, which engagement may include locking features such as a taper lock, a clip lock, a friction fit, threads and / or other known locking techniques, and / or the angle of the attachment prong relative to the angle of the bore. Once the attachment post is inserted, a rescue screw and / or fixation screw 4340 can be inserted through the lower fixation opening 4330 and into the lower vertebral body (not shown). FIG. 44 depicts an exploded view of the buttress plate with various associated implant components, and FIG. 45 depicts the buttress plate assembled with the associated implant components of FIG. 44.
[0234] Desirably, the buttress plate can provide a lowered angle of fixation for the inferior element, as well as provide for an alternative or “rescue” screw fixation option, such as where pedicular fixation may be unavailable or suboptimal, and / or where implant migration may have or is likely to occur. Such alteration of fixation and / or additional fixation support may be usefulin placement of implant components in offset vertebral levels as well as for those patients suffering from spondylolisthesis, scoliosis, lateral listhesis and / or other degenerative conditions.
[0235] If desired, the various system components described herein may be utilized in patients suffering from various degenerative spinal conditions, including spondylolisthesis, scoliosis, lateral listhesis and / or other offset and / or misaligned vertebral conditions. In various cases, a surgeon may elect to correct some aspect of a spinal misalignment to a more natural anatomical condition, while in other cases a surgeon may elect to simply accommodate an existing spinal condition with the implant components. For example, where a patient may be suffering from spondylolisthesis and / or other offset vertebral conditions, a surgeon may place implant components which do not correct or alleviate the offset condition(s), but which rather permit the patient to function normally without suffering from further degeneration and / or spinal degradation. In other situations, a surgeon may elect to correct or alleviate an offset condition and subsequently place implant components which accommodate the corrected anatomical condition.
[0236] Spinal Implant Placement
[0237] An exemplary surgical procedure to prepare a vertebral level and implant a physician’s selected implant such as those described herein will now be described. After the one or more spinal segments within each spinal region are prepared and / or resected to create the revised alignment line or resection plane 284 for implantation of one or more spinal implants 94a, 94b, 94c, the one or more dynamic spinal implants 94a, 94b, 94c may be deployed into the one or more prepared and / or resected spinal segments or spinal functional unit in one or more sides of the patient (right, left and / or right and left sides). Once the desired length and height of the one or more dynamic spinal implants 94a, 94b, 94c has been selected, the one or more spinal implants 94a, 94b, 94c can be positioned within at least one spinal functional unit or spinal segment 276a between an upper vertebra 12 and a lower vertebra 18 in one or more spinal regions between one or more upper vertebra 12 and a lower vertebra 18 on one or more sides of the patient as shown in FIG. 24A-24B, 26A-26D, 30A-30D, 33A and 33B.
[0238] With specific reference to FIGS. 24A-24B, one or more spinal implants 94a, 94b, 94c may be used to treat a single vertebral level or single vertebral segment 276a, between a single upper 12 and lower vertebra 18 in a right or left side of a patient. Alternatively, a single spinal implant 94a, 94b, 94c may be used to treat multiple vertebral levels or segments 276a, 276b, between multiple upper and lower vertebras in a right or left side of a patient. Furthermore, two or more spinal implants 94a, 94b, 94c may be used to treat a single vertebral level or single vertebral segment 276a, between a single upper 12 and lower vertebra 18 for the right and leftsides. Alternatively, two or more spinal implants 94a, 94b, 94c may be used to treat multiple vertebral levels or segments 276a, 276b, between multiple upper and lower vertebras in the right and left sides. The one or more dynamic spinal implants 94a, 94b, 94c may be deployed into a single spine segment 276a in a spinal region, and or multiple spinal segments 276a, 276b in one or more spinal regions. The spinal regions may comprise cervical, thoracic and lumbar regions. Accordingly, the one or more spinal implants 94a, 94b, 94c, may be deployed into different orientations for sagittal or coronal correction, the orientations comprise toe-in angles, coronal angles (or scoliotic angles), sagittal angles (or lordotic angles), and / or any combinations thereof.
[0239] The spinal implant 94a, 94b, 94c desirably includes an upper or superior element 96a, 96b, 96c, a lower or inferior element 98a, 98b, 98c, and a fixation screw 100a, 100b, 100c. The superior element 96a, 96b, 96c comprises a superior articulating component 106a, 106b, 106c and the inferior articulating component 108a, 108b, 108c. When the superior articulating component 106a, 106b, 106c contacts and engages the inferior articulating component 108a, 108b, 108c, it allows the superior articulating component 106a, 106b, 106c to move relative to the inferior articulating component 108a, 108b, 108c. Such movement mimics or substantially mimics the behavior of a normal functional spinal segment and / or unit. The motion includes at least one or more of flexion 270, extension 272, axial rotational motion 274 and / or lateral bending (not shown). The spinal region may include cervical, thoracic, lumbar, and / or any combination thereof.
[0240] In various embodiments, the at least one total joint or dynamic spinal implant 94a, 94b, 94c can be positioned at a desired toe-in angle 74 within at least one spinal functional unit or spinal segment 276a between an upper vertebra 12 and a lower vertebra 18 on a first side of the patient, such as shown in FIG. 26A. The spinal implant can comprise: an inferior element and a superior element; the superior element comprising a socket and the inferior element 98a, 98b, 98c comprises a articulation or ball component 108a, 108b, 108c with a ball articulation surface 226a, 226b, the ball articulation surface 226a, 226b of the ball component 108a, 108b, 108c of the inferior component 98a, 98b, 98c engages with the socket 119a, 119b, 119c of the superior element 96a, 96b, 96c to allow the superior element 96a, 96b, 96c to move relative to the inferior element 98a, 98b, 98c; the spinal implant 94a, 94b, 94c positioned at a toe-in angle 74 between an upper vertebra 12 and a lower vertebra 18 in a spinal region. The motion includes at least one or more of flexion 270, extension 272, axial rotational motion 274 and / or lateral bending (not shown). The spinal region may include cervical, thoracic, lumbar, and / or any combination thereof. The toe-in angle may include a range of 0 degrees to 40 degrees; arange of 10 degrees to 30 degrees; a range of 10 degrees to 20 degrees; a range of 20 degrees to 40 degrees, and / or any combination thereof. Alternatively, the toe-in angle may match or substantially match the transverse pedicle angle 74, 76, 78 as shown in FIGS. 5A-5D and 26A- 26D.
[0241] In another embodiment, the at least two spinal implants 94a, 94b, 94c can be positioned at a plurality of toe-in angles 74a, 74b within at least one spinal functional unit or spinal segment 276a between an upper vertebra 12 and a lower vertebra 18 on a both sides (e.g., first side and second side) of the patient as shown in FIG. 26A-26D and 27. A spinal implant may comprise a first spinal implant system 94a, the first spinal implant comprising a first inferior element and a first superior element; the first superior element comprising a socket; the first inferior element comprising a ball component, the ball component of the first inferior component engaging with the socket component of the first superior component to allow the first superior element to move relative to the first inferior element; and a second spinal implant system 94b, the second spinal implant comprising a second inferior element and a second superior element; the second superior element comprising a socket; the second inferior element comprising a ball component, the ball component of the second inferior component engaging with the socket of the second superior component to allow the second superior element to move relative to the second inferior element; the first spinal implant positioned at a first toe-in angle 74a between an upper vertebra 12 and a lower vertebra 18 in a spinal region; the second spinal implant positioned at a second toe-in angle 74b between the upper vertebra 12 and lower vertebra 18 in the spinal region. The motion includes at least one or more of flexion, extension, axial rotational motion and / or lateral bending flexion. The spinal region may include cervical, thoracic, lumbar, and / or any combination(s) thereof. The toe-in angle may include a range of 0 degrees to 40 degrees; a range of 10 degrees to 30 degrees; a range of 10 degrees to 20 degrees; a range of 20 degrees to 40 degrees, and / or any combination thereof. The first toe-in angle 74a may be the same as the second toe-in angle 74b. The first toe-in-angle may be different compared to the second toe-in angle. The first toe-in angle may match or substantially match the transverse pedicle angle on a first side, such as depicted in FIGS. 5A-5D and 26A-26D. The second toe-in angle may match or substantially match the transverse pedicle angle on the second side.
[0242] In another embodiment, at least two spinal implants can be positioned at a plurality of toe-in angles within two or more spinal functional units or spinal segments between a plurality of upper vertebras and a plurality of lower vertebras on a plurality of two sides (e.g., first and second sides) of the patient. However, when deploying implants in different spinal segments in different regions, the toe-in angles generally change or affect the motion of the spinal implantsto varying degrees. As described in FIG. 4B, 5A-5D and 26A-26D, each spinal segment within different spinal regions comprises different transverse pedicle angles and / or different toe-in angles for spinal implant deployment within the first or second sides. Furthermore, each spinal segment within the same spinal regions comprises different transverse pedicle angles and / or different toe-in angles for spinal implant deployment within the first or second sides.Accordingly, even a single spinal segment, the first and second sides can comprise different transverse pedicle angles and / or toe-in angles.
[0243] In one exemplary embodiment, shown in Table 1 below, one or more dynamic implants may alter or change the expected spinal motion when deployed in a variety of toe-in angulations relative to the vertebral body in a single spinal segment or multiple spinal segments within one or more spinal regions. Alternatively, one or more dynamic implants can alter or change the flexion and extension when deployed in a variety of toe-in angulations relative to each other in a single spinal segment or multiple spinal segments. In this manner, the various dynamic spinal implants described herein can provide a desired range of motion for a treated spinal level within any spinal region, regardless of implant alignment and / or natural anatomical variation.Table 1: Change in Flexion / Extension Relative to Toe-In Angle
[0244] In various exemplary embodiments, a spinal implant design and its implantation may be selected to desirably match and / or substantially match the natural or pre-surgical motion of a patient, which may significantly reduce pain and / or discomfort from soft tissues surrounding the treated level. In many cases, surgical procedures which fuse and / or even those that provide some motion to a treated level can cause significant pain and / or instability for extended post- surgical periods because these implants require extensive surgical access and they freeze and / or significantly alter the motion of the treated level from its presurgical state. It is well established that posterior spinal surgery results in damage to the paraspinal musculature, and surgical procedures which alter this spinal motion can cause atrophy of some paraspinal muscles such as the multifidus, as well as muscle spasms, loss of muscular support leading todisability and increased biomechanical strain in the treated and / or other muscle structures, significant loss in muscle density and strength. This can lead to a clinical condition called Failed Back Syndrome, which is undesirable. However, by allowing the surgeon to “tailor” the motion of the treated level (which may even include providing a different range of motion on each individual side of a treated vertebral level), and allowing the patient to resume motion virtually minutes or a few hours after a surgical procedure, the spinal implants described herein are a momentous enhancement to the spinal surgical space.
[0245] Accordingly, a spinal implant may be selected and / or positioned to match or substantially match a natural or original translational motion of a patient at each spine segment or level within a spine region. The spine regions may comprise cervical, thoracic, and / or lumbar regions. The spine segments may include cervical (CO - C7), thoracic (T1 - T12), and lumbar (L1-L5). The spine’s natural or original translation of motion comprises flexion, extension, lateral bending, axial rotation. Table 2 below only highlights a portion of the illustration of lumbar total ranges of motion (°) calculated from fixed-effect models for flexion-extension, lateral bending, and axial rotation, by level, with applied moments of ± 5 Nm and compressive loads of 0 and 500 N compared to data reported by White and Panjabi (1978) as evidenced in the article by Zhang et al., Moment-Rotation Behavior of Intervertebral Joints in Flexion-Extension, Lateral Bending, and Axial Rotation at all levels of the Human Spine: A Structured Review and MetaRegression Analysis, J. Biomech (February 13, 2020), which is herein incorporated by reference in its entirety. The remaining regions, cervical and thoracic, can be referenced within the article.
[0246] In various embodiments, spinal implants may be selected for implantation into a plurality of spinal levels to desirably alter and / or correct a spinal injury and / or degradation that may not be easily treatable or desirably treated using a single pair of spinal implants at a single spinal level. For example, where a 25-degree change in curvature a certain level is desired, it may be better for the surgeon to correct 15 degrees of curvature at a first spinal level and then correctthe remaining 10 degrees of curvature (or some other degree of curvature which may be due to kinematic variations at each spinal level) at a second spinal level. In such a case, the first plurality of spinal implants may be positioned at a first plurality of toe-in angles between the vertebral bodies of a first spinal segment, the spinal segment including an first upper vertebra and a first lower vertebra in a first spinal region; the second plurality of spinal implants being positioned at a second plurality of toe-in angles between a second spinal segment, the second spinal segment including a second upper vertebra and second lower vertebra in a second spinal region. The spinal region may include cervical, thoracic, lumbar, and / or any combination thereof, and the first and second spinal regions may involve some of the same vertebra (e.g., the first lower vertebrae of the first region is also the second upper vertebra of the second spinal region), or they may be spaced apart to varying degrees. By distributing the surgical alteration of spinal motion to multiple spinal regions, the disclosed procedures can dramatically reduce post-operative pain experienced by the patient, and also significantly reduce and / or eliminate post-operative instabilities experienced by many spinal surgery patients.
[0247] The first plurality and second plurality of toe-in angles and / or each of the first plurality and each of the second plurality of toe-in angles may include a range of 0 degrees to 40 degrees; a range of 10 degrees to 30 degrees; a range of 10 degrees to 20 degrees; a range of 20 degrees to 40 degrees, and / or any combination thereof. The first plurality of toe-in angle may be the same or different as the second plurality of toe-in angles. Each of the first plurality of toe-in angles may be the same or different on the medial and lateral sides of the treated vertebral bodies, as well as the second plurality of toe-in angles being the same or different. The first plurality of toe-in angles or each of the first plurality of toe-in angles may match or substantially match the transverse pedicle angles of the first and / or second sides in the first spinal segment. The second plurality of toe-in angles and / or each of the second plurality of toe- in angles may match or substantially match the second transverse pedicle angle of the first and / or second sides in the second spinal segment. The first spinal segment may be the same as the second spinal segment. The first spinal segment may be different than the second spinal segment. The first motion of the first plurality of spinal implants may be the same as the motion of the second spinal implant. The first motion of the first plurality of spinal implants may be different as the second motion of the second plurality of spinal implants.
[0248] With reference to FIGS. 28A-28B, 30A-30D, 31, 32A-32D, a change in orientation plane of a spinal implant can cause significant changes in motion of the treated level, including a possible lordotic correction or correction of sagittal imbalance. For example, a spinal implant positioned below the endplate plate plane and having a lordotic or sagittal orientation angle ororientation plane that is not parallel to the endplate plane will desirably create and / or correlate to a lordotic correction of the local spinal region. More specifically, a spinal implant having a posterior portion positioned below the endplate plate and having a lordotic or sagittal orientation angle or orientation plane of 4 degrees that is not parallel to the endplate plane can create and / or correlate to a lordotic correction of up to 14 degrees or greater.
[0249] Because of various anatomical differences between spinal levels or segments, some spinal segments will typically require and / or accommodate a greater degree of osteotomy correction than others. For example, at the L1 / L2 level, an osteotomy angle a of up to 10 degrees (i.e., a correction of from zero to 10 degrees) might easily be accomplished on one or both sides of a treated lower vertebral body using the disclosed system components, while retaining sufficient pedicular structure underneath the implant to maintain adequate implant support. At the L2 / L3 level, an osteotomy angle a of up to 15 degrees (i.e., a correction of from zero to 15 degrees) might be easily accomplished on one or both sides of a treated lower vertebral body, while retaining sufficient pedicular structure underneath the implant to maintain adequate implant support. At the L3 / L4 level, an osteotomy angle a of up to 20 degrees (i.e., a correction of from zero to 20 degrees) might be easily accomplished on one or both sides of a treated lower vertebral body, while retaining sufficient pedicular structure underneath the implant to maintain adequate implant support. At the L4 / L5 level, an osteotomy angle a of up to 25 degrees (i.e., a correction of from zero to 25 degrees) might be easily accomplished on one or both sides of a treated lower vertebral body, while retaining sufficient pedicular structure underneath the implant to maintain adequate implant support. At the L5 / S1 level, an osteotomy angle a of up to 30 degrees (i.e., a correction of from zero to 30 degrees) might be easily accomplished on one or both sides of a treated lower vertebral body, while retaining sufficient pedicular structure underneath the implant to maintain adequate implant support. Such a significant degree of surgical correction in a procedure utilizing a motion preserving implant is heretofore unheard of in spinal surgery, and such dramatic corrections are even infrequent attempted using fusion implants and / or other devices during other corrective surgeries.
[0250] In various embodiments, a differential resection plane may be accomplished on a first sider of the vertebral body as compared to the second side of the vertebral body. The first orientation plane or resected plane may be the same as the second orientation plane or resected plane. The first orientation or resected plane may be different than the second orientation or resected plane. The first and / or second orientation or resected plane 284 might be parallel to the endplate or anatomical plane 282. The first and / or the second orientation or resected plane 284 may be below the endplate or anatomical plane 282. The first and / or thesecond orientation or resected plane 284 may be below and parallel to the endplate or anatomical plane 282. The first and / or second orientation or resected plane may be at 0 degrees; the orientation or resected plane may comprise a range of -20 degrees to 20 degrees; the orientation or resected plane may comprise a range of -10 degrees to 10 degrees; the orientation or resected plane may comprise a range of -5 degrees to 5 degrees. The orientation or resected plane may match or substantially match a lordotic angle and / or sagittal angle. The orientation or resected plane may match or substantially match a scoliosis angle and / or a coronal angle.
[0251] In one embodiment, a spinal implant may be deployed within at least one spinal functional unit or spinal segment 276a between an upper vertebra 12 and a lower vertebra 18 on a first side of the patient in revised resected plane or implant orientation angle 284 parallel to the anatomical line or plane 282 as shown in FIGS. 26A-26B and 27A-27D. The resected plane or orientation angle 284 may be at the same plane as the endplate or anatomical plane 282.The resected plane 284 may be at a plane below the endplate or anatomical plane 284 as shown in the generalized sagittal cross-sectional view in FIGS. 27B and the generalized posterior cross-sectional view in FIG. 27D. Alternatively, a spinal implant may be deployed within at least one spinal functional unit or spinal segment 276a between an upper vertebra 12 and a lower vertebra 18 on a first side of the patient in deployment resected plane or implant orientation angle 284 that is not parallel and / or is oblique to the endplate or anatomical plane 282 as shown in FIGS. 26A-26B and 27A-27D. The resected plane or orientation angle 284 may be not parallel and / or oblique to the endplate or anatomical plane 282. The resected plane 284 may be at a plane below the endplate or anatomical plane 284 as shown in the generalized sagittal cross-sectional view in FIGS. 28C. The resected plane 284 may be at a plane below the endplate or anatomical plane 284 and not parallel or oblique to the endplate or anatomical plane 282 as shown in the generalized sagittal cross-sectional view in FIGS. 28C.
[0252] The first and second motion or movements may include at least one or more of flexion 270, extension 272, axial rotational motion 274 and / or lateral bending (not shown). The spinal region may include cervical, thoracic, lumbar, and / or any combination thereof. The three columns of the spine comprise an anterior column 88, a middle column 90, and a posterior column 92. The first orientation may be the same as the second orientation. The first orientation may be different than the first orientation. The first and / or second orientation may comprise a toe-in angle, a sagittal angle, a coronal angle and / or any combination thereof. The first toe-in angle 74a may be the same as the second toe-in angle 74b. The first toe-in-angle 74a may be different than the second toe-in angle 74b. The first toe-in angle 74a may match or substantiallymatch the transverse pedicle angle on a first side as shown in FIGS. 5A-5D. The second toe-in angle 74a may match or substantially match the transverse pedicle angle on the second side. The first toe-in angle may match or substantially match the first transverse pedicle angle and the second toe-in angle may match or substantially match the second transverse pedicle angle.
[0253] With reference to FIGS. 22A-22B and 23A-23B, a spinal implant desirably allows for removal and / or replacement of at least one facet and a portion of the intervertebral disc on each of the medial and lateral sides of the vertebral bodies. The facet joints comprise the inferior and superior articular processes, which are bony protuberances that arise vertically from the junction of pedicles and laminae behind the transverse processes. Furthermore, the facet joint has a capsule. The capsule consists of an outer layer made of densely packed parallel bundles of collagen fibers and an inner layer of irregularly oriented wavy elastic fibers that act like “rubber band” to coordinate movements within a spinal segment of a spinal region. The facet and the facet joints help guide and stabilize each spine segment, as well as help the spine to bend, twist, and extend in different directions. Although these joints enable movement, they also restrict excessive movement such as hyperextension and hyperflexion (i.e. whiplash).
[0254] Traditionally, during flexion 270 of the spine, the superior vertebral body may slide slightly anteriorly, tilting forward and compressing the anterior portions of the intervertebral discs. This simultaneously causes the inferior articular surface of the superior vertebra to move superiorly and anteriorly relative to the superior articular surface of the inferior vertebra, similar to a seesaw movement. The result is a posterior widening of the facet joint causing tension of the joint capsule of the facet joint to limit flexion 270. Since some or all of the facet joint may be removed by the surgical procedure associated with the present spinal implant, this traditional restraint obtained by the facet joint capsule and related structures will be reduced and / or missing and will be replaced by with one or more spinal implants.
[0255] In a similar manner, during extension of the spine, opposite actions typically occur. The superior vertebral body slides posteriorly, tilts backwards and compresses the posterior portion of the intervertebral discs. The inferior articular surface moves posteriorly and inferiorly, widening the anterior part of the facet joint. Extension is limited by tension of the anterior longitudinal ligament (ALL), impaction of the posterior vertebral processes and tone of the anterior neck (cervical spine only) and anterior abdominal muscles (thoracic spine only). As described above, some or all of the facet joint capsule and / or related facet structures are likely to be removed during the implantation procedure, and thus the traditional motion restraints provided by the facet joint would be reduced or not available.
[0256] The intervertebral discs are flat, round "cushions" that act as shock absorbers between each vertebra in your spine in all spine regions. Each disc has a strong outer ring of fibers called the annulus, and a soft, jelly-like center called the nucleus pulposus. The annulus is the disc's outer layer and the strongest area of the disc. It also helps keep the disc's center intact. The annulus is a strong ligament that connects each vertebra together. The mushy nucleus of the disc serves as the main shock absorber.
[0257] In various embodiments, a spinal implant may incorporate a metal inferior articulation component and a superior articulation component comprising a polymer and a metal. The metal may comprise Cobalt Chrome (CoCr) and / or Titanium. The polymer may comprise ultra-high weight molecular polyethylene (UHWMPE). The polymer may comprise an antioxidant. The antioxidant includes Vitamin E. The vitamin E and the polymer has a low frictional resistance and improves or enhances fatigue, wear and impact resistance, making it to be an ideal bearing surface for implants. As assembled, the superior articulation component articulation surface of the superior element may engage the articulation surface of the inferior element to produce a ball-and-socket style articulation joint that allows shock absorption and motion or movement of the superior element relative to the inferior element. The superior articulation component may desirably comprise a polymer and Vitamin E which contacts and / or engages with the metallic inferior articulation component, allowing the polymer component to flex or deform during the movement or motion of the spine. The polymer may also allow some deformation and elasticity to emulate or simulate the movement of the center of rotation of a natural disc.
[0258] In various embodiments, the spinal implant may stabilize the treated level in a manner similar to the facet joint by limiting or restricting anterior migration or sliding. The posterior wall or posterior tab of the superior element desirably restrict unwanted motion during movement of the treated level. At least a portion of the posterior wall or posterior tab can contact a posterior rim surface of the superior vertebra to prevent or restrict anterior migration or sliding. Accordingly, at least a portion of the anterior facing surface of the posterior wall or posterior tab may contact the apophyseal ring of the superior vertebra to prevent and / or limited anterior migration or sliding.
[0259] It should be understood that various combinations of the different implant embodiments disclosed herein are contemplated in the present disclosure. For example, it may be advantageous for a physician to utilize implant components of differing heights, widths and / or sizes in the medial and lateral sides of a single spinal level, depending upon the surgical goals as well as the patient’s particular anatomy. Similarly, a physician may elect to use an offset implant design for a medial side of a vertebral level, while a non-offset design might be used ona lateral side of the same treated vertebral level. Accordingly, all combinations of the individual components of the various embodiments disclosed are expressly contemplated, and these various combinations are disclosed herein.
[0260] Equivalents
[0261] The invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing embodiments are therefore to be considered in all respects illustrative rather than limiting on the invention described herein. Scope of the invention is thus intended to include all changes that come within the meaning and range of equivalency of the descriptions provided herein.
[0262] Many of the aspects and advantages of the present invention may be more clearly understood and appreciated by reference to the accompanying drawings. The accompanying drawings are incorporated herein and form a part of the specification, illustrating embodiments of the present invention and together with the description, disclose the principles of the invention.
[0263] Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, it will be readily apparent to those of ordinary skill in the art in light of the teachings of this invention that certain changes and modifications may be made thereto without departing from the spirit or scope of the disclosure herein. What have been described above are examples of the present invention. It is, of course, not possible to describe every conceivable combination of components or methodologies for purposes of describing the present invention, but one of ordinary skill in the art will recognize that many further combinations and permutations of the present invention are possible. Accordingly, the present invention is intended to embrace all such alterations, modifications and variations that fall within the spirit and scope of the appended claims.
Claims
CLAIMSWhat is claimed:1 . A prosthetic system for treating offset vertebrae, the prosthetic system comprising: an upper joint component comprising an upper joint body and an upper articulating insert, the upper joint body including an upper anterior end, an upper posterior end, an upper keel, an upper bone contacting surface and an upper tab positioned substantially transverse to the upper keel, the upper tab extending upwards from the upper bone contacting surface, the upper tab being spaced apart from the upper posterior end, the upper articulating insert comprising an upper anterior motion limiter, an upper posterior motion limiter, and a concave upper articulation surface; a lower joint component comprising a lower joint component material, lower keel, a lower bone contacting surface, a lower anterior motion limiter, a lower posterior motion limiter, and a convex lower articulation surface, the convex lower articulation surface engages with the concave upper articulation surface to allow the upper joint component to move relative to the lower joint component from a first position, the first position comprising the upper anterior motion limiter contacting at least a portion of the lower anterior motion limiter to allow a first motion, to a second position comprising the upper posterior motion limiter contacting at least a portion the lower posterior motion limiter to allow a second motion; and a bridge component extending posteriorly from the lower joint component, the bridge component having a bridge bone contacting surface, the lower bone contacting surface and the bridge bone contacting surface are coplanar, at least a portion of the bridge bone contacting surface being adapted to contact a portion of a resected pedicle, the bridge component further comprises a connection component adapted to receive a fastener.
2. The prosthetic system of claim 1 , wherein the upper tab is in direct contact with the upper keel.
3. The prosthetic system of claim 1 , wherein the upper tab is positioned above and anterior to lower posterior motion limiter.
4. The prosthetic system of claim 1 , wherein the upper tab is positioned above and posterior to the concave upper articulation surface.
5. The prosthetic system of claim 1 , wherein the upper anterior end of the upper joint body extends over and is anterior to a lower anterior end of the lower joint component when the prosthetic system is implanted.
6. A prosthetic system for implantation between offset upper and lower vertebrae, the system comprising: an upper joint component comprising a metallic upper contact surface and a polyethylene upper articulation surface; a lower joint component comprising a first lower contact surface for engaging a cancellous bone surface exposed by resection of one or more endplate surfaces of the lower vertebrae and a metallic lower articulation surface configured to movably engage the polyethylene upper articulation surface to form an articulating joint, wherein the articulating joint is adapted for implantation within a disc space between the offset upper and lower vertebrae in their offset orientation, allowing the offset upper and lower vertebrae to move relative to one another; and a bridge component extending posteriorly from the lower joint component and from the disc space, the bridge component having a second lower contact surface configured for engaging a resected bone surface of a pedicle of the lower vertebrae, wherein the distal end of the bridge component comprises a tab which extends downward from the second lower contact surface and a connection component adapted to receive a fastener.
7. The prosthetic system of claim 6, wherein the upper joint component comprises an upper anterior end, an upper posterior end and an upper keel having an upper tab positioned substantially transverse to the upper keel at a posterior end thereof, the upper tab being spaced apart from the upper posterior end of the upper joint component.
8. The prosthetic system of claim 6, wherein the tab includes a tab surface which is positioned generally perpendicular to the second lower contact surface.
9. The prosthetic system of claim 8, wherein the tab surface directly contacts the second lower contact surface.
10. The prosthetic system of claim 6, wherein an anterior end of the upper joint component extends forward of an anterior end of the lower joint component when the prosthetic system is implanted between the offset upper and lower vertebrae.
11. A prosthetic system for implantation between offset upper and lower vertebrae, the system comprising: an upper joint component comprising a metallic upper contact surface and a polyethylene upper articulation surface; a lower joint component comprising a first lower contact surface for engaging a cancellous bone surface exposed by resection of one or more endplate surfaces of the lower vertebrae and a metallic lower articulation surface configured to movably engage the polyethylene upper articulation surface to form an articulating joint, wherein the articulating joint is adapted for implantation within a disc space between the offset upper and lower vertebrae in their offset orientation, allowing the offset upper and lower vertebrae to move relative to one another; a bridge component extending posteriorly from the lower joint component and from the disc space, the bridge component having a second lower contact surface configured for engaging a resected bone surface of a pedicle of the lower vertebrae, and a connection component adapted to receive a fastener; and a modular buttress for selective attachment to the connection component, the modular buttress including a prong for positioning in the connection component, a plate surface extending downward from the prong, and a lower fixation opening adapted to receive a second fastener, the lower fixation opening extending through plate surface.
12. The prosthetic system of claim 11 , wherein at least a portion of the plate surface extends below a keel surface of the lower joint component when the prong is positioned in the connection component.
13. The prosthetic system of claim 11 , wherein the lower fixation opening of the plate surface is positioned below a keel surface of the lower joint component when the prong is positioned in the connection component.
14. The prosthetic system of claim 11 , wherein the plate surface comprises a plurality of openings extending from a front surface to a back surface thereof.
15. The prosthetic system of claim 11 , wherein the second fastener can be positioned parallel to the second lower contact surface when the prong is positioned in the connection component.
16. The prosthetic system of claim 11 , wherein the second fastener can be positioned parallel to the first lower contact surface when the prong is positioned in the connection component.
17. The prosthetic system of claim 11 , wherein an anterior end of the upper joint component extends forward of an anterior end of the lower joint component when the prosthetic system is implanted between the offset upper and lower vertebrae.
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