Spinal plate and cage

Abstract

Machine learning and intelligent planning techniques are disclosed for fabricating spinal fusion plates and spinal cages that can be utilized as a system together to provide a precision guided anterior cervical discectomy and fusion (ACDF) surgery to a subject in need thereof. The spinal fusion plate provides adjustments of one or more vertebrae even after attaching the plate to the spine of the subject. The spinal fusion plate provides a surgical window or "postbox" for accessing the intervertebral space(s) of the subject, provides the postbox window for precision insertion of a spinal cage, provides a locking inset to prevent over-insertion of the spinal cage, and provides precision compression of the spinal cage after the insertion. Methods of treating subjects in need of a discectomy surgery are described herein utilizing the precision implants.

Description

SPINAL PLATE AND CAGECROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit from U.S. Provisional Patent Application Serial No. 63 / 631 ,390, filed April 8, 2024, which is incorporated by reference in its entirety.FIELD OF THE INVENTION

[0002] The embodiments of the present invention relate to intelligently designed implants and surgical patient care systems in the form of spinal plates, spinal cages, and interlocking spinal systems to provide precision guided surgeries for correcting problems in anterior cervical discectomy and fusion (ACDF) surgeries. The technology disclosed herein can also be utilized in other spine discectomy and vertebral fusion surgeries, namely of the thoracolumbar and lumbosacral spine.BACKGROUND OF THE INVENTION

[0003] Anterior cervical discectomy and fusion (ACDF) is a surgical procedure to treat nerve root or spinal cord compression by decompressing the spinal cord and nerve roots of the cervical spine with a discectomy, followed by inter-vertebral fusion to stabilize the corresponding vertebrae around the removed disc. The ACDF procedure is typically used when other non-surgical treatments have failed.

[0004] A diagnosis of the nerve compression can involve an MRI, a CT scan (with and without myelogram), an X-ray, somatosensory evoked potential, and electromyography. The healthcare provider will investigate the patient’s history and the treatment process, or lack of treatment, for nerve damage, tingling, immobility, and other signs and symptoms. A CT scan and an MRI can be critical in diagnosis of the extent of disc damage. There may be bone spurs or other structures impinging upon the spine or associated nerves.

[0005] The vertebral column, vertebrae, and one or more herniated discs are usually accessed from the neck or other anterior structures. The nucleus pulposus (the jelly-like center of the disc) of the herniated disc bulges out through the annulus (surrounding wall, or annulus fibrosus) and presses on the nerve root next to it, so the disc is penetrated by the surgeon, and the nucleus pulposus is removed. The entire disc might be removed. The disc includes about 70%-80% water. The normal agingprocess can cause discs to dry and shrink, causing tears in the annulus fibrosus and inflammation of the spinal nerve root nearby. The current ACDF procedures involve removal of the herniated or damaged disc. A number of discs might need removal. The surrounding vertebrae are left largely unsupported while the surgeon locates a spinal plate that will fuse the surrounding vertebra, along with a bone graft and / or spinal cage to insert into the spaces left by the removed discs. The area of the spine is distracted (or lengthened), the spinal cage or bone graft is inserted into the space, and then a spinal plate is fastened over the space, usually with screws, fusing the surrounding vertebrae. If there is a misalignment, the spinal cage is not compressed properly, or the space between vertebrae is not correct after installing the spinal plate, a different size or shape plate must be found. What is urgently needed are intelligently designed discectomy and spinal fusion systems that provide precision guided surgery during the procedures and eliminate problems of the prior are implants.BRIEF SUMMARY OF THE INVENTION

[0006] The following presents a simplified summary of the innovation in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the invention. It is intended to neither identify key or critical elements of the invention nor delineate the scope of the invention. Its sole purpose is to present some concepts of the invention in a simplified form as a prelude to the more detailed description that is presented later.

[0007] A critical problem in discectomy and vertebral fusion surgeries is that the spinal plates do not provide adjustments during the surgical process to provide appropriate compression on the spinal cage. The currently available spinal plates cover over the area of the discectomy (e.g., spinal plate 1500 shown in FIG. 9) after a spinal cage has been inserted, and re-adjustment of the intervertebral space is not possible after fastening the spinal plate. As will be discussed in more detail below, there are additional problems with current ACDF implants.

[0008] The older implant technologies do not guide a precision surgery to an optimum outcome, and instead, place a huge burden on the surgeon to make critical decisions during the surgery. In a broad embodiment, the technology herein provides an implant system that is intelligently thought out and planned to provide a precision surgical outcome, namely, that the spinal cage will be precision guided by the spinalplate implant, during and after the discectomy, to be positioned accurately where it should be for long-term healing and fusion.

[0009] In some embodiments, the implants disclosed herein can include markings on the implants. According to some aspects, the markings guide the surgeon to the exact discectomy site, where to insert a spinal cage, and how deep to insert. According to some aspects, the implant systems include interlocking or contacting insets and wings, to guide the spinal cage to its exact position between vertebrae. In this example, the implant systems can include a mating spinal plate and spinal cage, prepared for the surgery. One or more vertebral level can be fused by the technology herein, and the spinal plates disclosed herein can be made larger to span multiple vertebrae for fusions and insertion of multiple spinal cages.

[0010] As an example solution to the problem discussed above, the technology herein provides, in some embodiments, a spinal fusion plate for use in an anterior discectomy surgery to remove an intervertebral disc from a subject in need thereof, the spinal fusion plate comprising: A) a fixed bracket positioned over a vertebra of the subject, the bracket including one or more fastener holes; each hole operative to accept a fastener through the fixed bracket and into the vertebra of the subject; wherein the fastener fits into the one or more holes and prevents a substantial movement of the bracket, and whereby the fixed bracket is thus affixed to the vertebra; B) two fusion posts extending away from the fixed bracket along the spine of the subject and fusing to a height adjustment bracket that is positioned over a proximal vertebra of the subject; the two fusion posts defining a space between the two posts along with a space or a postbox between the fixed bracket and the height adjustment bracket; the two fusion posts each including an inset operative to hold a wing of a spinal cage at the posts when a spinal cage with wings is inserted into the postbox; and C) the height adjustment bracket including one or more fastener holes, each hole operative to accept a fastener through the adjustment bracket and in the proximal vertebra of the subject, wherein each of the one or more holes allows a sliding to and fro of the proximal vertebra within the postbox when the fastener is loosened and each hole immobilizes the proximal vertebra when the fastener is tightened; wherein the spinal fusion plate is configured as a precision guided surgical implant for use in a discectomy surgery by a surgeon attaching the fixed bracket and the adjustment bracket to two adjacent vertebrae, loosening a fastener on the adjustment plate, moving the proximal vertebra, and tightening the fastener on the adjustment plate.

[0011] Thus, the presently disclosed technology can provide a new spinal plate the enables adjustment of the subject’s spine during the surgery, even after the plate is affixed to the spine.

[0012] The spinal fusion plate can be, according to some aspects, further comprising a spinal cage including two anti-protrusion wings, one wing disposed at one corner of the cage and the other wing disposed at an opposite corner, both wings capable of engaging the insets of the two fusion posts when the cage is inserted into the postbox; and wherein the engaging stops a further insertion of the cage into the spine of the subject. In this example, the engaging of the wings with the insets prevents an excessive posterior displacement of the spinal cage into the subject’s spinal canal.

[0013] The technology disclosed herein also provides methods of treating a subject in need of an anterior discectomy surgery, the method comprising the steps of: (1 ) obtaining a surgical assessment of the subject, whereby data from the subject’s spine with a disc defect is acquired; (2) performing one or more discectomies on one or more defective discs; (3) obtaining a spinal fusion plate comprising any or all of the features discussed above; (4) fastening the fixed bracket and the height adjustment bracket to the spine of the subject, wherein the postbox is positioned over the intervertebral space where the discectomy was executed; (5) loosening one or more fasteners on the height adjustment bracket and moving the proximal vertebra whereby the proximal vertebra is translated superiorly; then tightening the fasteners to hold the proximal vertebra superiorly; (6) inserting a spinal cage into the postbox until the two wings affixed to the cage engage with the insets of the fusion posts; and (7) loosening the one or more fasteners on the height adjustment bracket and moving the proximal vertebra down to compress the spinal cage; and tightening the one or more fasteners to hold the cage in the compression.

[0014] In this example, the method can be, in some embodiments, further comprising wherein step (4) is executed as: (4) fastening the fixed bracket and the height adjustment bracket to the spine of the subject, wherein the postbox is positioned over a defective disc to be removed via a discectomy and executing the discectomy by excising at least a portion of the disc through the postbox window, whereby the discectomy is executed after the fixed bracket and the height adjustment bracket are affixed to the spine of the subject.

[0015] The method of treating can be executed, according to some aspects, further comprising two additional fusion posts extending along the spine of the subjecton the side of the height adjustment bracket opposite the fixed bracket; the two additional posts extending to a second height adjustment bracket; the two additional fusion posts defining a space between the two additional posts along with a second space or a second postbox between the height adjustment bracket and the second height adjustment bracket; the two additional fusion posts each including an inset operative to hold a wing of a second spinal cage at the posts when a second spinal cage with wings is inserted into the second postbox; and wherein the second height adjustment bracket is operative to be affixed to a vertebra that is adjacent to the proximal vertebra of the subject, and the method further comprising the steps of: (8) fastening the second height adjustment bracket to the spine of the subject, wherein the second postbox is positioned over a second intervertebral space where a second discectomy was executed; (9) loosening one or more fasteners on the second height adjustment bracket and moving the adjacent vertebra whereby the adjacent vertebra is translated superiorly; then tightening the fasteners to hold the adjacent vertebra superiorly; (10) inserting a second spinal cage into the second postbox until two wings affixed to the second cage engage with the insets of the two additional fusion posts; and (11 ) loosening the one or more fasteners on the second height adjustment bracket and moving the adjacent vertebra down to compress the second spinal cage; then tightening the one or more fasteners to hold the second cage in the compression.

[0016] As will be discussed in more detail below, the technology disclosed herein solves many of the larger problems in spinal fusion surgeries and in discectomy surgeries.

[0017] Other implementations are also described and recited herein. These and other features and advantages will be apparent from a reading of the following detailed description and a review of the associated drawings. It is to be understood that both the foregoing general description and the following detailed description are explanatory only and are not restrictive of aspects as claimed.BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Solely for the purpose of illustration, certain embodiments of the present invention are explained using examples in the drawings described below. It should be understood, however, that the invention is not limited to the precise arrangements, dimensions, and configurations shown. In the drawings:

[0019] FIG. 1 shows an anterior view of a vertebral column 100 with vertebrae and intervertebral discs, a spinal plate P of the present technology is positioned spanning two vertebra with one intervertebral disc, and a spinal cage E of the present technology is shown with anti-protrusion wings G. The postbox C provides a surgical window. Sliding screw holes are depicted at A, and fixed or round screw holes at B. The spinal plates P of the present technology can be used to span multiple vertebrae (not shown) and to provide for surgery on multiple intervertebral discs and can have more than one postbox C to provide surgical windows for multiple intervertebral discs. As used throughout this specification, the term “postbox” can be referred to as a “wedge window”.

[0020] FIG. 2 shows the vertebral column 100 after a discectomy has been performed at 6, removing at least a portion of disc 4. The spinal plate P has been applied spanning the intervertebral space between vertebrae 3 and 5. It is important to note that the discectomy at 6 can be performed before applying the spinal plate P or can be performed after applying the spinal plate P.

[0021] FIG. 3 shows the spinal plate P attached to vertebra 3 at top with screws 30 affixed in sliding screw holes A. Adjustment spaces 34 are left around the screws 30. The bottom fixed bracket 20 of the spinal plate P is affixed to vertebra 5 with screws 32 in fixed or round holes B; (i.e., A and B are shown without the screws in FIG. 1 ).

[0022] FIG. 4 shows an axial view of a vertebra 3 to illustrate a slight ellipse curvature to the height adjustment bracket 10. Unlike prior art spinal plates, the current technology allows a 90-90° screw placement into the vertebrae. The spinal plates of the current technology can have a thicker center at 12 with thinner ‘wing’ at 13 (each can be a different thickness), along with a slight ellipse curvature (to fit the vertebra) allowing a 90-90° screw placement. A bracket thickness in the range of about 1 -4 mm is illustrated, along with views of screw placement into the vertebra. It should be understood that the slight ellipse curvature (to fit a face or facet of a vertebra) can also be applied to a fixed bracket 20 (not shown) or the entire spinal plate P.

[0023] FIG. 5 illustrates how the screws 30 in the sliding screw holes A have been slightly loosened and arrows 50 that depict how, with a spreader (not shown), the proximal vertebra can be translated superiorly (50); then a larger space (indicated by double arrow or distraction 55) is opened to distract around and at the post discectomy region 6. At this point, once distracted space 55 is suitable for insertion ofa spinal cage, the screws 30 can be re-tightened to hold the (now) larger space 55 open to facilitate insertion of the spinal cage through the postbox C.

[0024] FIG. 6 shows an axial view at the disc level after implantation of the spinal cage E by inserting the cage E through the postbox C or surgical window into the space 6 from where at least a portion of the disc 4 was removed (e.g., FIG. 5) and the wings G on the cage E now engage with the insets D of the postbox, preventing excessive posterior displacement of the cage E into the spinal canal X.

[0025] FIG. 7 illustrates a coronal view of the vertebral column 100 post implantation of the spinal cage E.

[0026] FIG. 8 shows a coronal view of the vertebral column 100, wherein the screws 30 are loosed to release the distraction 55 (FIG. 5); after release of the distraction 55 (FIG. 5) as illustrated by movement and compression of the cage at 60, now the screws 30 in the sliding screw holes A are tightened, leaving an adjustment space 37 around the screws 30. The spinal cage E is now in a compressed state.

[0027] FIG. 9 (prior art) shows a photo of a prior art anterior cervical plate in place after an ACDF surgery.

[0028] FIG. 10 shows a flow diagram of a method 500 to make an anterior cervical plate system of the technology provided herein.

[0029] FIG. 11 shows an example method 600 of treating a subject in need of a discectomy surgery or an ACDF (anterior cervical discectomy and fusion surgery).

[0030] FIG. 12 (prior art) shows a coronal view of two prior art spinal plates screwed into example vertebrae with fixed options and limitations discussed below (e.g., https: / / isulmed.com / pdf / Brochures / Medtronic / ATLANTIS-VISION-ELITE- BROCHURE.pdf).

[0031] FIG. 13 (prior art) shows an axial view of a prior art spinal plate screwed into example transparent vertebrae.

[0032] FIG. 14 (prior art) shows an ACDF surgery without the new technology disclosed herein, wherein vertebrae 1001 , 1010, and 1020 have little to no support and guidance because intervertebral disc 1003 has already been removed and intervertebral disc 1005 is in the process of being removed by the surgeon.

[0033] It should be understood that while different numbers / numbering are / is sometimes used in some of the figures above to describe different embodiments and different aspects of the technology, any number from any figure can be inter-combined with a numbered aspect from any other figures. All trademarks, images, likenesses,words, and depictions in the drawings and the disclosure are plainly in fair use and are provided solely for the purposes of illustration of the invention in view of an urgent need to treat subjects as further discussed in detail below.DETAILED DESCRIPTION OF THE INVENTION

[0034] The subject innovation is now described in some instances, when necessary, with reference to the drawings. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the present invention. It may be evident, however, that the present invention may be practiced without these specific details. In other instances, well- known structures, methods, and devices are shown in block diagram form or with illustrations in order to facilitate describing the present invention. It is to be appreciated that certain aspects, modes, embodiments, variations and features of the invention are described below in various levels of detail in order to provide a substantial understanding of the present invention.DEFINITIONS

[0035] For convenience, the meaning of some terms and phrases used in the specification, examples, and appended claims, are provided below. Unless stated otherwise, or implicit from context, the following terms and phrases include the meanings provided below. The definitions are provided to aid in describing particular embodiments, and are not intended to limit the claimed invention, because the scope of the invention is limited only by the claims. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. If there is an apparent discrepancy between the usage of a term in the art and its definition provided herein, the definition provided within the specification shall prevail. In general, typical chemical terminology is found in the International Union of Pure and Applied Chemistry GoldBook1. This disclosure is purposefully presented in commonly understood words, known to a person of skill in the art, but Merriam-Webster’s Online Dictionary is used, when appropriate, for terms not specifically demonstrated herein or not known in the art2.

[0036] As used in this specification and the appended claims, the singular forms "a," "an" and "the" include plural referents unless the content clearly dictatesotherwise. For example, reference to "a cell" includes a combination of two or more cells, and the like.

[0037] As used herein, the term "approximately" or "about" in reference to a value or parameter are generally taken to include numbers that fall within a range of 5%, 10%, 15%, or 20% in either direction (greater than or less than) of the number unless otherwise stated or otherwise evident from the context (except where such number would be less than 0% or exceed 100% of a possible value). As used herein, reference to "approximately" or "about" a value or parameter includes (and describes) embodiments that are directed to that value or parameter. For example, description referring to "about X" includes description of "X".

[0038] As used herein, the term “or” means “and / or.” The term "and / or" as used in a phrase such as "A and / or B" herein is intended to include both A and B; A or B; A (alone); and B (alone). Likewise, the term "and / or" as used in a phrase such as "A, B, and / or C" is intended to encompass each of the following embodiments: A, B, and C; A, B, or C; A or C; A or B; B or C; A and C; A and B; B and C; A (alone); B (alone); and C (alone).

[0039] As used herein, the term "comprising" means that other elements can also be present in addition to the defined elements presented. The use of "comprising" indicates inclusion rather than limitation. The term “including” can be interchanged with “comprising”.

[0040] The term "consisting of" refers to compositions, methods, and respective components thereof as described herein, which are exclusive of any element not recited in that description of the embodiment.

[0041] As used herein the term "consisting essentially of" refers to those elements required for a given embodiment. The term permits the presence of additional elements that do not materially affect the basic and novel or functional characteristic(s) of that embodiment of the invention. The term “consisting essentially of” can also be exemplified by plain language provided in the claims.

[0042] As used herein, the term “implant” can be used interchangeably with “spinal plate” or “spinal cage”.

[0043] The term "statistically significant" or "significantly" refers to statistical significance and generally means a two-standard deviation (2SD) or greater difference.

[0044] As used herein, the term "subject" refers to a mammal, including but not limited to a dog, cat, horse, cow, pig, sheep, goat, rodent, or primate. Subjects can be house pets (e.g., dogs, cats), agricultural stock animals (e.g., cows, horses, pigs, chickens, etc.), laboratory animals (e.g., mice, rats, rabbits, etc.), but are not so limited. Subjects particularly include human subjects in urgent treatment as described herein. The human subject may be a pediatric, adult, or a geriatric subject. The human subject may be of any sex.

[0045] The term “treating” includes prophylactic and / or therapeutic treatments. The term “prophylactic or therapeutic” treatment is art-recognized and includes administration to the host of one or more of the subject compositions and / or application of one or more therapies or surgeries. If this is done prior to clinical manifestation of the unwanted condition (e.g., disease or other unwanted state of the host animal) then the treatment is prophylactic (i.e., it protects the host against developing the unwanted condition), whereas if it is administered after manifestation of the unwanted condition, the treatment is therapeutic, (i.e., it is intended to diminish, ameliorate, or stabilize the existing unwanted condition or side effects thereof).

[0046] As used herein, the terms “treat,” “treatment,” “treating,” or “amelioration” when used in reference to a disease, disorder, or medical condition, refer to therapeutic surgeries or treatments for a condition, wherein the object is to reverse, alleviate, ameliorate, inhibit, slow down or stop the progression or seventy of a symptom or condition. The term “treating” includes reducing or alleviating at least one adverse effect or symptom of a condition. Treatment is generally “effective” if one or more symptoms or clinical markers are reduced. Alternatively, treatment is “effective” if the progression of a condition is reduced or halted. That is, “treatment” includes not just the improvement of symptoms or markers, but also a cessation or at least slowing of progress or worsening of symptoms that would be expected in the absence of treatment. Beneficial or desired clinical results include, but are not limited to, alleviation of one or more symptom(s), sign(s), diminishment of extent of the deficit, stabilized (i.e., not worsening) state of a symptom or condition, delay or slowing of onset of symptoms or indications, and an increased lifespan as compared to that expected in the absence of treatment.

[0047] The terms: “decrease”, “reduced”, “reduction”, or “inhibit” are all used herein to mean a decrease by a statistically significant amount. In some embodiments, “reduce,” “reduction" or “decrease" or “inhibit” typically means a decrease by at least10% as compared to a reference level (e.g., the absence of a given treatment or agent) and can include, for example, a decrease by at least about 10%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, at least about 98%, at least about 99% , or more. As used herein, “reduction” or “inhibition” does not encompass a complete inhibition or reduction as compared to a reference level. “Complete inhibition” is a 100% inhibition as compared to a reference level. A decrease can be preferably down to a level accepted as within the range of normal for an individual without a given disorder.

[0048] In some embodiments, the decrease in the one or more signs or symptoms is evaluated according to a specialized healthcare provider. In some embodiments, signs are observed or measured by a health care provider. Symptoms can be reported by the subject. In some embodiments, the decrease of signs or symptoms occurs in less than about 120 days, 90 days, less than about 60 days, less than about 30 days, less than about 15 days, less than about 10 days, or less than about 5 days, or less than about 3 days, or less than about 1 day. In some embodiments, the decrease of signs or symptoms occurs in less than 1 day, less than 1 week, less than 1 month, or in less than 1 year.

[0049] The terms “increased”, “increase”, “enhance”, or “activate” are all used herein to mean an increase by a statically significant amount. In some embodiments, the terms “increased”, “increase”, “enhance”, or “activate” can mean an increase of at least 10% as compared to a reference level, for example an increase of at least about 20%, or at least about 30%, or at least about 40%, or at least about 50%, or at least about 60%, or at least about 70%, or at least about 80%, or at least about 90% or up to and including a 100% increase or any increase between 10-100% as compared to a reference level, or at least about a 2-fold, or at least about a 3-fold, or at least about a 4-fold, or at least about a 5-fold or at least about a 10-fold increase, or any increase between 2-fold and 10-fold or greater as compared to a reference level. In the context of a marker or symptom, a “increase” is a statistically significant increase in such level.

[0050] As used herein, an agent or a therapeutic agent provided to a subject and suspected to be or involved in a treatment can be a small molecule less than 1000 MW or a large molecule not less than 1000 MW including biologies, oligonucleotides,peptides, oligosaccharides, and larger molecules. Any of the therapeutic agents disclosed herein can be used as or in combination with small molecules and / or large molecules as discussed herein.

[0051] A subject can be one who has been previously diagnosed with or identified as suffering from or having a condition in need of treatment (e.g., a spinal nerve compression, pain, weakness, numbness, tingling, a bone spur, arthritis, or a related disorder) or one or more complications related to such a condition, and optionally, but need not have already undergone treatment for a condition or the one or more complications related to the condition. Alternatively, a subject can also be one who has not been previously diagnosed as having a condition in need of treatment or one or more complications related to such a condition. For example, a subject can be one who exhibits one or more risk factors for a condition, or one or more complications related to a condition or a subject who does not exhibit risk factors. A “subject in need” of treatment for a particular condition can be a subject having that condition, diagnosed as having that condition, suspected as having, or at risk of developing that condition. In another example, the subject has been brought into a treatment situation entirely without the subject’s knowledge and / or intent. For example, a subject can obviously be in need of treatment but not be responsive to a previous surgery, and as described herein the present methods and implants may save the subject’s life.

[0052] As discussed above, unless otherwise defined herein, scientific and technical terms used in connection with the present application shall have the meanings that are commonly understood by those of ordinary skill in the art to which this disclosure belongs. It should be understood that this invention is not limited to the particular methodology, protocols, devices, implants, and reagents, etc., described herein and as such can vary. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the present invention, which is defined solely by the claims. Definitions of common terms in immunology and molecular biology can be found in The Merck Manual of Diagnosis and Therapy;3The Encyclopedia of Molecular Cell Biology and Molecular Medicine;4Molecular Biology and Biotechnology: a Comprehensive Desk Reference;5Immunology;6Janeway's Immunobiology;7Lewin's Genes XI;8Molecular Cloning: A Laboratory Manual.;9Basic Methods in Molecular Biology;10Laboratory Methods in Enzymology;11Current Protocols in Molecular Biology (CPMB)12; Current Protocols in Protein Science (CPPS);13and Current Protocols in Immunology (CPI)14.

[0053] In the embodiments discussed and in any of the aspects, the disclosure described herein does not concern a process for cloning human beings, processes for modifying the germ line genetic identity of human beings, uses of human embryos for industrial or commercial purposes or processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

[0054] Other terms are defined herein within the description of the various aspects of the invention. It is clearly contemplated herein that the technology can be used in surgeries in addition to ACDF, and the implants and techniques disclosed herein are not limited by the accurate discussion of applications in ACDF surgeries.SPINAL PLATE AND CAGE

[0055] Now considered a routine neck surgery on the human spine, the anterior cervical discectomy and fusion (ACDF) involves removing one or more damaged intervertebral discs to relieve spinal cord or nerve root pressure and alleviate corresponding pain, weakness, numbness, and tingling. A discectomy is a form of surgical decompression, so the procedure may also be called an anterior cervical decompression. An ACDF surgery can be done to treat a symptomatic cervical herniated disc, and it may also be done for cervical degenerative disc disease. It is also commonly done to remove bone spurs (osteophytes) caused by arthritis and to alleviate the symptoms associated with cervical spinal stenosis. ACDF surgery is a relatively fast procedure because of the minimally invasive nature, however surgical times can vary depending on the number of spinal levels (individual vertebrae) being operated on at a time. Typically, it can take about 90 minutes to about 120 minutes of surgical time to perform a single-level ACDF. The surgery can require pre-selection of parts before surgery begins, and if the correct parts are not present during surgery, the process places tremendous strain on the surgeon, the spine, and the patient.

[0056] The ACDF procedure begins with an anterior cervical discectomy. The vertebral column is accessed through the anterior, or front, of the cervical spine (neck). A needle is typically inserted into the defective disc by the surgeon to confirm the correct disc is accessed. The annulus fibrosis of the disc is penetrated with surgical tools, and a portion of the disc, the nucleus pulposus (central area of the disc) is removed, or all of the disc is removed.

[0057] A portion of the disc may be left. In general, the disc is removed from between two vertebral bones. The surgeon examines the posterior longitudinal ligament (PLL) for damage. A portion of the PLL may need removed to access bone spurs or other damage to the PLL. A major problem during the surgery is that the disc is removed from between two vertebral bones, and there is little guidance and support for the two bones for the next procedure, which involved placing a spinal cage and / or a bone graft into the space once occupied by the damaged disc. After inserting the cage and / or graft, a spinal plate (e.g., FIG. 9, FIG. 12, FIG. 13) is used to fuse the vertebrae above and below the removed disc. Unfortunately, a large problem is the spinal plate must be placed over the inserted cage and / or graft, screwed into the vertebrae, and the surgeon has no adjustment room to adjust compression on the graft and / or cage. Furthermore, another problem is once in place, the spinal plate does not enable access to the spinal cage and / or graft. The problems place tremendous pressure on surgeons and complicate recoveries for patients. In an example, using prior art technologies (e.g., FIG. 9, FIG. 12, FIG. 13), if a surgeon finds the compression on the spinal cage is not correct, the alignment is not correct, or the fusion is not correct, the entire spinal plate must be unscrewed to examine and / or readjust the surgery. The technology disclosed herein provides a solution to the above problems, along with other benefits for patients.

[0058] As an example solution to the problems discussed above, the technology herein provides, in some embodiments, a spinal fusion plate for use in an anterior discectomy surgery to remove an intervertebral disc from a subject in need thereof, the spinal fusion plate comprising: A) a fixed bracket positioned over a vertebra of the subject, the bracket including one or more fastener holes; each hole operative to accept a fastener through the fixed bracket and into the vertebra of the subject; wherein the fastener fits into the one or more holes and prevents a substantial movement of the bracket, and whereby the fixed bracket is thus affixed to the vertebra; B) two fusion posts extending away from the fixed bracket along the spine of the subject and fusing to a height adjustment bracket that is positioned over a proximal vertebra of the subject; the two fusion posts defining a space between the two posts along with a space or a postbox between the fixed bracket and the height adjustment bracket; the two fusion posts each including an inset operative to hold a wing of a spinal cage at the posts when a spinal cage with wings is inserted into the postbox; and C) the height adjustment bracket including one or more fastener holes, each holeoperative to accept a fastener through the adjustment bracket and in the proximal vertebra of the subject, wherein each of the one or more holes allows a sliding to and fro of the proximal vertebra within the postbox when the fastener is loosened and each hole immobilizes the proximal vertebra when the fastener is tightened; wherein the spinal fusion plate is configured as a precision guided surgical implant for use in a discectomy surgery by a surgeon attaching the fixed bracket and the adjustment bracket to two adjacent vertebrae, loosening a fastener on the adjustment plate, moving the proximal vertebra, and tightening the fastener on the adjustment plate.

[0059] Thus, the presently disclosed technology can provide a new spinal plate the enables adjustment of the subjects spine during the surgery, even after the plate is affixed to the spine.

[0060] The spinal fusion plate can be, according to some aspects, further comprising a spinal cage including two anti-protrusion wings, one wing disposed at one corner of the cage and the other wing disposed at an opposite corner, both wings capable of engaging the insets of the two fusion posts when the cage is inserted into the postbox; and wherein the engaging stops a further insertion of the cage into the spine of the subject. In this example, the engaging of the wings with the insets prevents an excessive posterior displacement of the spinal cage into the subject’s spinal canal.

[0061] To introduce more details to the solutions newly disclosed herein, in some embodiments, FIG. 1 shows an anterior view of a vertebral column 100 with vertebrae 1 , 3, 5 and intervertebral discs 2, 4, a spinal plate P of the present technology is positioned spanning two vertebra 3, and 5, with one intervertebral disc 4, and a spinal cage E of the present technology is shown with anti-protrusion wings G. The postbox C provides a surgical window. Sliding screw holes are depicted at A, and fixed or round screw holes at B. The spinal plates P of the present technology can be used to span multiple vertebrae (not shown) and to provide for surgery on multiple intervertebral discs and can have more than one postbox C to provide surgical windows for multiple intervertebral discs. The fixed bracket 20 has a fusion post 14 and a fusion post 16 extending away to a height adjustment bracket 10. The height adjustment bracket 10 has sliding (or oval) screw holes A that enable vertebra 3 to be moved even after the plate P is affixed to the spine. Insets D can hold a wing G of a spinal cage when the cage is inserted into the postbox C. The wings can be used to prevent inserting the spinal cage too far, for example, into the subject’s spinal canal. Screw locks F can be used to lock down the spinal screws (not shown).

[0062] According to some aspects, the spinal plate is wherein the plate includes a biocompatible material comprising stainless steel, a cobalt base alloy, a bio-ceramic, a titanium alloy, a pure titanium, a composite material, a non-resorbable polymers, a bioresorbable polymer, or a combination thereof. Portions of the implants can be resorbable, and portions can be non-resorbable. Any materials known in the art can be used. In some embodiments, the spinal cage includes a biocompatible material comprising stainless steel, a cobalt base alloy, a bio-ceramic, a titanium alloy, a pure titanium, a composite material, a non-resorbable polymers, a bioresorbable polymer, or a combination thereof.

[0063] In some embodiments, the spinal plate is compatible with a bone adhesive, operative to adhere the plate to the vertebrae of the subject. In this example, no holes may be required for bone screws.

[0064] In some embodiments, the spinal fusion plate described above is further comprising two additional fusion posts extending along the spine of the subject on the side of the height adjustment bracket opposite the fixed bracket; the two additional posts extending to a second height adjustment bracket; the two additional fusion posts defining a space between the two additional posts along with a second space or a second postbox between the height adjustment bracket and the second height adjustment bracket; the two additional fusion posts each including an inset operative to hold a wing of a second spinal cage at the posts when a second spinal cage with wings is inserted into the second postbox; and wherein the second height adjustment bracket is operative to be affixed to a vertebra that is adjacent to the proximal vertebra of the subject.

[0065] According to some aspects, the fixed bracket has an elliptical curvature or a curvature to follow an outer, anterior curvature of the vertebra to which the bracket is affixed. In some embodiments, the height adjustment bracket has an elliptical curvature or a curvature to follow an outer, anterior curvature of the vertebra to which the bracket is affixed.

[0066] In embodiments with a second height adjustment bracket, the second height adjustment bracket can have an elliptical curvature or a curvature to follow an outer, anterior curvature of the vertebra to which the bracket is affixed.

[0067] According to some aspects, wherein the one or more fastener holes in the fixed bracket include round screw holes. In some embodiments, the one or morefastener holes in the height adjustment bracket are configured as oval screw holes or as sliding screw holes.

[0068] In some embodiments, the postbox includes a portion of the vertebra and a portion of the proximal vertebra visible from the postbox when the spinal fusion plate is affixed to the spine of the subject.

[0069] According to some aspects, the spinal fusion plate further comprises one or more screw locks F at or near on or more fastener holes (FIG. 1), the one or more screw locks operative to prevent a screw from loosening after the screw has been tightened into a fastener hole.

[0070] In some embodiments, the spinal fusion plate is capable of being affixed to the spine of the subject after a discectomy has been performed; and wherein the postbox of the spinal fusion plate is positioned over the area where the discectomy was performed, enabling a view of the intervertebral space where the disc has been removed..

[0071] FIG. 2 shows the vertebral column 100 after a discectomy has been performed at 6, removing at least a portion of disc 4 seen in postbox C. The spinal plate P has been applied spanning the intervertebral space between vertebrae 3 and 5. It is important to note that the discectomy at 6 can be performed before applying the spinal plate P or can be performed after applying the spinal plate P.

[0072] In some embodiments, the spinal fusion plate is capable of being affixed to the spine of the subject before a discectomy has been performed, allowing the discectomy to be executed through the postbox or space, allowing the proximal vertebra to be moved after the discectomy, then allowing the proximal vertebra to be fixed in position after an insertion of a spinal cage through the postbox. In this example, FIG. 3 shows area 6 in postbox C where a discectomy can be performed. In another example, a surgeon can begin a discectomy without the plate P attached to the spine, attach plate P a way when then discectomy is partially done, and then complete the discectomy through postbox C after attaching the spinal plate P.

[0073] FIG. 3 shows the spinal plate P attached to vertebra 3 at top with screws 30 affixed in sliding screw holes A. Adjustment spaces 34 are left around the screws 30. The bottom fixed bracket 20 of the spinal plate P is affixed to vertebra 5 with screws 32 in fixed or round holes B; (i.e., A and B are shown without the screws in FIG. 1 ). In some embodiments, whereupon when one or more fasteners are loosened on the height adjustment bracket 10, a spreader can be used to translate the proximalvertebra superiorly (FIG. 5) and the one or more fasteners are then tightened to hold the proximal vertebra superiorly.

[0074] FIG. 4 shows an axial view of a vertebra 3 to illustrate a slight ellipse curvature to the height adjustment bracket 10. A bracket thickness in the range of about 1 -4 mm is illustrated, along with views of screw placement into the vertebra. It should be understood that the slight ellipse curvature (to fit a face or facet of a vertebra) can also be applied to fixed bracket 20 (not shown) or the entire spinal plate P. In the example of FIG. 4, or for any embodiment herein, the spinal plates of the current technology can have a thicker center at 12 with thinner ‘wing’ (resembling a butterfly) at 13 (each can be a different thickness), along with a slight ellipse curvature (to fit the vertebra) allowing a 90-90° screw placement. In some embodiments, the spinal plate 10 can be described a asymmetrical on the axial plane (FIG. 4). According to some aspects, the plate can be about 1 -4 mm thick, or about 1.8 mm, optionally about 2.0 mm, optionally about 2.2 mm, optionally about 2.4 mm, or any range subsumed between.

[0075] According to some aspects, when the proximal vertebra 3 is translated superiorly 50 (see FIG. 5) and held, a spinal cage E with wings G on two opposite corners is inserted into the postbox C until the wings G engage (FIG. 6) with the insets D of the two fusion posts. FIG. 5 illustrates how the screws 30 in the sliding screw holes A have been slightly loosened and arrows 50 that depict how, with a spreader (not shown), the proximal vertebra 3 can be translated superiorly (50); then a larger space (indicated by double arrow or distraction 55) is opened to distract around and at the post discectomy region 6. At this point, once distracted space 55 is suitable for insertion of a spinal cage E, the screws 30 can be re-tightened to hold the (now) larger space 55 open to facilitate insertion of the spinal cage through the postbox C.

[0076] In some embodiments, the one or more fasteners are loosened to allow for a movement of the proximal vertebra towards the spinal cage, allowing for a compression of the spinal cage between the vertebra and the proximal vertebra; whereafter the one or more fasteners are re-tightened to hold the spinal cage in the compression.

[0077] In some embodiments, the spinal cage further comprises spinal cage fastener positions or screw holes 31 operative (FIG. 7) to further hold the spinal cage in a position in the subject’s intervertebral space. In some embodiments, the screwholes allow a screw to be placed into the cage and travel about at 40-50° into a vertebra, where the angle is measured from a parallel line to the spinal column.

[0078] FIG. 6 shows an axial view at the disc level after implantation of the spinal cage E by inserting the cage E through the postbox C or surgical window into the space 6 from where at least a portion of the disc 4 was removed (e.g., FIG. 5) and the wings G on the cage E now engage with the insets D of the postbox, preventing excessive posterior displacement of the cage E into the spinal canal X.

[0079] FIG. 7 illustrates a coronal view of the vertebral column 100 post implantation of the spinal cage E. The wings G on the spinal cage have engaged with the insets D (FIG. 1). The spinal cage of the present technology provides screw holes at 31. Screws can affix the cage to the vertebrae above and below. Vertebra 3 is still translated superiorly as indicated by the spaces or adjustment spaces 36 under the screws 30.

[0080] FIG. 8 shows a coronal view of the vertebral column 100, wherein the screws 30 are loosed to release the distraction 55 (FIG. 5); after release of the distraction 55 (FIG. 5) as illustrated by movement and compression of the cage at 60, now the screws 30 in the sliding screw holes A are tightened, leaving an adjustment space 37 around the screws 30. The spinal cage E is now in a compressed state.

[0081] In some embodiments (now shown), the spinal fusion plate can be further comprising one or more markings on an anterior surface or on a surface of the plate and / or the cage; each of the one or more markings indicative of a position for a surgeon to perform a discectomy, a position for the cage to be mounted to a vertebra, a position for a fastener to be moved to or for a vertebra to be moved to, an alignment position, a position of a rotation, or a combination thereof.

[0082] According to some aspects, the spinal cage comprises a width in a range from about 5 mm to about 20 mm, in a range from about 10 mm to about 15 mm, or in a range from about 12 mm to about 13 mm (e.g., FIG. 6).

[0083] In some embodiments, the spinal fusion plate comprises a thickness in a range from about 0.5 mm to about 5 mm, in a range from about 1 mm to about 3 mm, or in a range from about 1 .4 mm to about 2.4 mm (e.g., FIG. 4).

[0084] In some embodiments, the spinal fusion plate is configured further comprising wherein one or more fastener holes are omitted and an adhesive is utilized to fix the bracket to the vertebra at or near the location where the one or more fastener holes are omitted.

[0085] According to some aspects, a method of treating a subject in need of an anterior discectomy surgery is disclosed herein, the method comprising the steps of: (1 ) obtaining a surgical assessment of the subject, whereby data from the subject’s spine with a disc defect is acquired; (2) performing one or more discectomies on one or more defective discs; (3) obtaining a spinal fusion plate comprising: A) a fixed bracket positioned over a vertebra of the subject, the bracket including one or more fastener holes; each hole operative to accept a fastener through the fixed bracket and into the vertebra of the subject; wherein the fastener fits into the one or more holes and prevents a substantial movement of the bracket, and whereby the fixed bracket is thus affixed to the vertebra; B) two fusion posts extending away from the fixed bracket along the spine of the subject and fusing to a height adjustment bracket that is positioned over a proximal vertebra of the subject; the two fusion posts defining a space between the two posts along with a space or a postbox between the fixed bracket and the height adjustment bracket; the two fusion posts each including an inset operative to hold a wing of a spinal cage at the posts when a spinal cage with wings is inserted into the postbox; and C) the height adjustment bracket including one or more fastener holes, each hole operative to accept a fastener through the adjustment bracket and in the proximal vertebra of the subject, wherein each of the one or more holes allows a sliding to and fro of the proximal vertebra within the postbox when the fastener is loosened and each hole immobilizes the proximal vertebra when the fastener is tightened; (4) fastening the fixed bracket and the height adjustment bracket to the spine of the subject, wherein the postbox is positioned over the intervertebral space where the discectomy was executed; (5) loosening one or more fasteners on the height adjustment bracket and moving the proximal vertebra whereby the proximal vertebra is translated superiorly; then tightening the fasteners to hold the proximal vertebra superiorly; (6) inserting a spinal cage into the postbox until the two wings affixed to the cage engage with the insets of the fusion posts; and (7) loosening the one or more fasteners on the height adjustment bracket and moving the proximal vertebra down to compress the spinal cage; and tightening the one or more fasteners to hold the cage in the compression.

[0086] In some embodiments, the method of treating is wherein the engaging of the wings with the insets prevents an excessive posterior displacement of the spinal cage into the subject’s spinal canal.

[0087] According to some aspects, the method of treating is further comprising two additional fusion posts extending along the spine of the subject on the side of the height adjustment bracket opposite the fixed bracket; the two additional posts extending to a second height adjustment bracket; the two additional fusion posts defining a space between the two additional posts along with a second space or a second postbox between the height adjustment bracket and the second height adjustment bracket; the two additional fusion posts each including an inset operative to hold a wing of a second spinal cage at the posts when a second spinal cage with wings is inserted into the second postbox; and wherein the second height adjustment bracket is operative to be affixed to a vertebra that is adjacent to the proximal vertebra of the subject, and the method further comprising the steps of: (8) fastening the second height adjustment bracket to the spine of the subject, wherein the second postbox is positioned over a second intervertebral space where a second discectomy was executed; (9) loosening one or more fasteners on the second height adjustment bracket and moving the adjacent vertebra whereby the adjacent vertebra is translated superiorly; then tightening the fasteners to hold the adjacent vertebra superiorly; (10) inserting a second spinal cage into the second postbox until two wings affixed to the second cage engage with the insets of the two additional fusion posts; and (11 ) loosening the one or more fasteners on the second height adjustment bracket and moving the adjacent vertebra down to compress the second spinal cage; then tightening the one or more fasteners to hold the second cage in the compression.

[0088] In some embodiments, the method of treating is further comprising wherein step (4) is executed as described here, instead of the step (4) shown as above: (4) fastening the fixed bracket and the height adjustment bracket to the spine of the subject, wherein the postbox is positioned over a defective disc to be removed via a discectomy and executing the discectomy by excising at least a portion of the disc through the postbox window, whereby the discectomy is executed after the fixed bracket and the height adjustment bracket are affixed to the spine of the subject.

[0089] According to some aspects, the method of treating is further comprising wherein step (8) is executed as described here, instead of the step (8) shown above: (8) fastening the second height adjustment to the spine of the subject, wherein the second postbox is positioned over a defective disc to be removed via a discectomy and executing the discectomy by excising at least a portion of the disc through thesecond postbox window, whereby the discectomy is executed after the fixed bracket and the second height adjustment bracket are affixed to the spine of the subject.

[0090] In some embodiments, the method of treating is wherein the engaging of the wings of the second spinal cage with the insets of the two additional fusion posts prevents an excessive posterior displacement of the second spinal cage into the subject’s spinal canal. According to some aspects, the one or more fastener holes in the height adjustment bracket are configured as oval screw holes or as sliding screw holes.

[0091] In some embodiments, the method of treating is wherein the loosening in steps (5) and (7) causes an ability to move a vertebra of the subject to and fro.

[0092] According to some aspects, the method of treating is further comprising the surgeon uses a spreader to translate a vertebra superiorly.

[0093] In some embodiments, the method of treating is further comprising wherein one or more fastener holes are omitted and a surgeon utilizes an to affix a bracket to the vertebra at or near the location where the one or more fastener holes are omitted.

[0094] According to some aspects, the method of treating is further comprising one or more of the following steps of surgical planning methods are executed: one or more radiographs are loaded on a surgical planning software; a spinal fusion plate contour is planned to match a unique bone contour of the subject; a spinal cage is sized and / or shaped to match a unique intervertebral area of the subject; one or more positions of one or more fasteners are planned to fasten the spinal plate to a vertebra of the subject; a data-driven, artificial-intelligence, and / or machine-learning process is utilized to determine a size, contour, or window on the spinal fusion plate to ensure perfect execution of the surgical plan following a data established spine contour of the subject; and a screw trajectory and / or an adhesive placement is planned using overlays of one or more prototype spinal plates, robotic assistance, and / or ultrasound guidance.

[0095] The method of treating can, in some embodiments, be further comprising an intraoperative verification of the spinal plate is performed including one or more of measurements of the subject’s spine and / or the spinal plate during a surgery from one or more assigned targets using radiography, fluoroscopy, computerized tomography (CT), robotics, and / or ultrasound.

[0096] The method of treating can, according to some aspects, be further comprising a pre-operative surgical plan is assessed using one or more of a healthcare provider’s examination of the subject, an ultrasound, and / or a robotic assisted exam.

[0097] In some embodiments, the method of treating can be wherein one or more markings on the spinal plate are used to indicate an area to perform a discectomy, an area to mount the spinal plate to a vertebra, or an area for a fastener.

[0098] In some embodiments, the method of treating can be further comprising making one or more iterative adjustments of the spinal plate and / or to the spinal cage.

[0099] According to some aspects, the method of treating can be executed wherein a screw placement is provided with a positioning designed with a specific angulation to tie to the spinal plate, a fluoroscopy image, a robot, a navigation plan through a plate’s projected position in the subject’s spine, an ultrasound, and / or wherein the plate at least partially requires or dictates a screw location and orientation.

[0100] In some embodiments, the devices disclosed herein change the order of steps in a typical fusion surgery. For example, in prior art surgeries, a spinal cage can be inserted after a discectomy but before attaching a spinal plate. This leads to serious risks of dislocation of the spinal cage. In prior art surgeries there is serious risk of spine damage because of a spinal cage that is pushed too far in. In the present technology, a discectomy can be performed. A spinal plate can be affixed, then the spinal cage can be inserted. The presently disclosed technology prevents any imprecision in the position of the spinal cage. After the spinal plate is affixed, in some embodiments, a discectomy can be done or completed. Bone spurs can be removed through the ‘postbox’. The technology provides precision guided surgeries.

[0101] In some embodiments, a method of making a spinal plate is disclosed herein, wherein the spinal plate comprises A), B), and C): A) a fixed bracket positioned over a vertebra of the subject, the bracket including one or more fastener holes; each hole operative to accept a fastener through the fixed bracket and into the vertebra of the subject; wherein the fastener fits into the one or more holes and prevents a substantial movement of the bracket, and whereby the fixed bracket is thus affixed to the vertebra; B) two fusion posts extending away from the fixed bracket along the spine of the subject and fusing to a height adjustment bracket that is positioned over a proximal vertebra of the subject; the two fusion posts defining a space between the two posts along with a space or a postbox between the fixed bracket and the height adjustment bracket; the two fusion posts each including an inset operative to hold awing of a spinal cage at the posts when a spinal cage with wings is inserted into the postbox; and C) the height adjustment bracket including one or more fastener holes, each hole operative to accept a fastener through the adjustment bracket and in the proximal vertebra of the subject, wherein each of the one or more holes allows a sliding to and fro of the proximal vertebra within the postbox when the fastener is loosened and each hole immobilizes the proximal vertebra when the fastener is tightened; and wherein the method is comprising the steps of: (1 ) in a computer system having at least a processor, software, and memory; receiving data representing a surgical assessment of a subject’s spine, including data for a disc with a defect; (2) superimposing a targeted spinal plate shape and / or size over the data; (3) adjusting the superimposed targeted spinal plate in a shape and / or size of a postbox or surgical window to achieve a fit for the subject’s spine; (4) outside of the computer system, outputting data for the adjusted plate and / or window suitable for either manufacturing a spinal plate and window and manufacturing such, or suitable for obtaining a premanufactured spinal plate and window; (5) providing the plate with the window or postbox for a surgery for the subject; and whereby the surgery, the plate, and the postbox window provide a planned surgical outcome and will correct the disc in the subject.

[0102] The method of making can be executed wherein the data representing a surgical assessment of the subject includes X-ray data, CT data, or MRI data of the disc with the defect.

[0103] According to some aspects, the method of making is wherein step (3) further comprises: fitting an elliptical shape of a bracket of the spinal plate to fit an anterior surface of a vertebra of the subject, fitting a longitudinal shape of the spinal plate to fit a curvature of the subject’s spine, or a combination thereof.

[0104] In some embodiments, the method of making can be further comprising placing one or more marking one the spinal plate, and wherein the spinal plate includes one or more markings operative to indicate to a surgeon where a discectomy site is planned during the surgery, where a fastener is planned to be located, or where a spinal plate or a bracket is to be affixed to a vertebra of the subject.

[0105] According to some aspects, the method of making is executed wherein the adjusting of the plate’s size, shape, and / or postbox window is further computed using one or more artificial intelligence (Al) methods or machine learning algorithms.

[0106] In some embodiments, the method of making is further comprising a planning of one or more positions and / or depths of one or more fasteners or adhesions for the spinal plate to a vertebra of the subject; the one or more positions and / or depths configured to fit the vertebra of the subject.

[0107] In some embodiments, the method of making is executed wherein one or more artificial intelligence (Al) methods or machine learning algorithms are utilized to determine fastener or adhesion positions on the spinal plate.

[0108] According to some aspects, the method of making is further comprising generating a fastener trajectory and / or an adhesion scheme using a navigation, a robotic assistance, and / or an ultrasound input.

[0109] In some embodiments, the method of making disclosed above is wherein step (2) is further comprising: superimposing a targeted spinal cage shape and / or size over the data. In this example, according to some aspects, the method can be wherein step (3) is further comprising: adjusting the superimposed spinal cage in a shape and / or a size of the postbox or surgical window to achieve a fit for the subject’s intervertebral space; and wherein step (4) is further comprising: outside of the computer system, outputting data for the adjusted cage suitable for either manufacturing a spinal cage and manufacturing such, or suitable for obtaining a premanufactured spinal cage; and wherein step (5) is further comprising: providing the spinal cage for a surgery for the subject.

[0110] According to some aspects, the method of making is further comprising executing a follow-up surgical assessment on the subject’s spine after a healing time, obtaining additional post-surgical data from the subject; and further comprising inputting a datum into the computer system so as to improve a future manufacturing of a future spinal plate.

[0111] In some embodiments, a kit suitable for a sale is provided by the technology herein, the kit comprising at least one spinal plate with a surgical window or postbox window for use in accessing an intervertebral area of a spine in a subject in need thereof, the plate comprising: A) a fixed bracket positioned over a vertebra of the subject, the bracket including one or more fastener holes; each hole operative to accept a fastener through the fixed bracket and into the vertebra of the subject; wherein the fastener fits into the one or more holes and prevents a substantial movement of the bracket, and whereby the fixed bracket is thus affixed to the vertebra; B) two fusion posts extending away from the fixed bracket along the spine of thesubject and fusing to a height adjustment bracket that is positioned over a proximal vertebra of the subject; the two fusion posts defining a space between the two posts along with a space or a postbox between the fixed bracket and the height adjustment bracket; the two fusion posts each including an inset operative to hold a wing of a spinal cage at the posts when a spinal cage with wings is inserted into the postbox; and C) the height adjustment bracket including one or more fastener holes, each hole operative to accept a fastener through the adjustment bracket and in the proximal vertebra of the subject, wherein each of the one or more holes allows a sliding to and fro of the proximal vertebra within the postbox when the fastener is loosened and each hole immobilizes the proximal vertebra when the fastener is tightened; wherein the spinal plate is configured as a surgical implant for use by a surgeon as a precision guided surgical implant for use in a discectomy surgery by a surgeon attaching the fixed bracket and the adjustment bracket to two adjacent vertebrae, loosening a fastener on the adjustment plate, moving the proximal vertebra, and tightening the fastener on the adjustment plate.

[0112] According to some aspects, the kit is further comprising instructions for use in a media format of a video, instructions with illustrations, written instructions, or a combination thereof.

[0113] In some embodiments, the methods disclosed herein are further comprising the step of: scanning a shape of the implant and using a software program to compare the shape to an image of the subject to determine if the implant is in an optimum shape and / or size for the subject or a bone of the subject. For example, the image of the subject can include an X-ray.

[0114] In any interpretation of the claims appended hereto, it is noted that no claims or claim elements are intended to invoke or be interpreted under 35 U.S.C. 112(f) unless the words “means for” or “step for” are explicitly used in the particular claim.

[0115] In general, any combination of disclosed features, components and methods described herein is possible. Steps of a method can be performed in any order that is physically possible.

[0116] All cited references are incorporated by reference herein. Although embodiments have been disclosed, it is not desired to be limited thereby. Rather, the scope should be determined only by the appended claims.

[0117] While various embodiments of the present disclosure have been described in detail, it is apparent that modifications and alterations of those embodiments will occur to those skilled in the art. However, it is to be expressly understood that such modifications and alterations are within the scope and spirit of the present disclosure, as set forth in the following claims.

[0118] The foregoing discussion of the disclosure has been presented for purposes of illustration and description. The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description for example, various features of the disclosure are grouped together in one or more embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed disclosure requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

[0119] Moreover, though the present disclosure has included description of one or more embodiments and certain variations and modifications, other variations and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative embodiments to the extent permitted, including alternate, interchangeable and / or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and / or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

[0120] The description of embodiments of the disclosure is not intended to be exhaustive or to limit the disclosure to the precise form disclosed. While specific embodiments of, and examples for, the disclosure are described herein for illustrative purposes, various equivalent modifications are possible within the scope of the disclosure, as those skilled in the relevant art will recognize. For example, while method steps or functions are presented in a given order, alternative embodiments may perform functions in a different order, or functions may be performed substantially concurrently. The teachings of the disclosure provided herein can be applied to other procedures or methods as appropriate. The various embodiments described hereincan be combined to provide further embodiments. Aspects of the disclosure can be modified, if necessary, to employ the compositions, functions and concepts of the above references and application to provide yet further embodiments of the disclosure. Moreover, due to biological functional equivalency considerations, some changes can be made in protein structure without affecting the biological or chemical action in kind or amount. These and other changes can be made to the disclosure in light of the detailed description. All such modifications are intended to be included within the scope of the appended claims.

[0121] Specific elements of any of the foregoing embodiments can be combined or substituted for elements in other embodiments. Furthermore, while advantages associated with certain embodiments of the disclosure have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the disclosure. The methods, kits, formulations, and devices disclosed herein can be combined in any way into systems to address the current public health emergency.

[0122] The machine learning methods and artificial intelligence methods described herein can be implemented in any suitable computing system. The computing system can be implemented as or can include a computer device that includes a combination of hardware, software, and firmware that allows the computing device to run an applications layer or otherwise perform various processing tasks. Computing devices can include without limitation personal computers, workstations, servers, laptop computers, tablet computers, mobile devices, wireless devices, smartphones, wearable devices, embedded devices, microprocessor-based devices, microcontroller-based devices, programmable consumer electronics, mini-computers, main frame computers, and the like and combinations thereof.

[0123] Processing tasks can be carried out by one or more processors. Various types of processing technology can be used including a single processor or multiple processors, a central processing unit (CPU), multicore processors, parallel processors, or distributed processors. Additional specialized processing resources such as graphics (e.g., a graphics processing unit or GPU), video, multimedia, or mathematical processing capabilities can be provided to perform certain processing tasks. Processing tasks can be implemented with computer-executable instructions, such as application programs or other program modules, executed by the computingdevice. Application programs and program modules can include routines, subroutines, programs, scripts, drivers, objects, components, data structures, and the like that perform particular tasks or operate on data.

[0124] Processors can include one or more logic devices, such as small-scale integrated circuits, programmable logic arrays, programmable logic devices, masked- programmed gate arrays, field programmable gate arrays (FPGAs), application specific integrated circuits (ASICs), and complex programmable logic devices (CPLDs). Logic devices can include, without limitation, arithmetic logic blocks and operators, registers, finite state machines, multiplexers, accumulators, comparators, counters, look-up tables, gates, latches, flip-flops, input and output ports, carry in and carry out ports, and parity generators, and interconnection resources for logic blocks, logic units and logic cells.

[0125] The computing device includes memory or storage, which can be accessed by a system bus or in any other manner. Memory can store control logic, instructions, and / or data. Memory can include transitory memory, such as cache memory, random access memory (RAM), static random-access memory (SRAM), main memory, dynamic random-access memory (DRAM), block random access memory (BRAM), and memristor memory cells. Memory can include storage for firmware or microcode, such as programmable read only memory (PROM) and erasable programmable read only memory (EPROM). Memory can include non- transitory or nonvolatile or persistent memory such as read only memory (ROM), onetime programmable non-volatile memory (OTPNVM), hard disk drives, optical storage devices, compact disc drives, flash drives, floppy disk drives, magnetic tape drives, memory chips, and memristor memory cells. Non-transitory memory can be provided on a removable storage device.

[0126] A computer-readable medium can include any physical medium that is capable of encoding instructions and / or storing data that can be subsequently used by a processor to implement embodiments of the systems and methods described herein. Physical media can include floppy discs, optical discs, CDs, mini-CDs, DVDs, HD-DVDs, Blu-ray discs, hard drives, tape drives, flash memory, or memory chips. Any other type of tangible, non-transitory storage that can provide instructions and / or data to a processor can be used in the systems and methods described herein.

[0127] The computing device can include one or more input / output interfaces for connecting input and output devices to various other components of the computingdevice. Input and output devices can include, without limitation, keyboards, mice, joysticks, microphones, cameras, webcams, displays, touchscreens, monitors, scanners, speakers, and printers. Interfaces can include universal serial bus (USB) ports, serial ports, parallel ports, game ports, and the like.

[0128] The computing device can access a network over a network connection that provides the computing device with telecommunications capabilities Network connection enables the computing device to communicate and interact with any combination of remote devices, remote networks, and remote entities via a communications link. The communications link can be any type of communication link including without limitation a wired or wireless link. For example, the network connection can allow the computing device to communicate with remote devices over a network which can be a wired and / or a wireless network, and which can include any combination of intranet, local area networks (LANs), enterprise-wide networks, medium area networks, wide area networks (WANS), virtual private networks (VPNs), the Internet, cellular networks, and the like. Control logic and / or data can be transmitted to and from the computing device via the network connection. The network connection can include a modem, a network interface (such as an Ethernet card), a communication port, a PCMCIA slot and card, or the like to enable transmission to and receipt of data via the communications link. A transceiver can include one or more devices that both transmit and receive signals, whether sharing common circuitry, housing, or a circuit boards, or whether distributed over separated circuitry, housings, or circuit boards, and can include a transmitter-receiver.

[0129] The computing device can include a browser and a display that allow a user to browse and view pages or other content served by a web server over the communications link. A web server, sever, and database can be located at the same or at different locations and can be part of the same computing device, different computing devices, or distributed across a network. A data center can be located at a remote location and accessed by the computing device over a network. The computer system can include architecture distributed over one or more networks, such as, for example, a cloud computing architecture. Cloud computing includes without limitation distributed network architectures for providing, for example, software as a service (SaaS).

[0130] The technology described herein is further illustrated by the following examples which in no way should be construed as being further limiting. The Examplesare provided to demonstrate examples of future planned work, which in some experiments is emergency work. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of this disclosure, suitable methods and materials are described below.EXAMPLES

[0131] The invention now being generally described with the spirit of the invention and inventive concept described and illustrated, it will be more readily understood by reference to the following examples which are included merely for purposes of illustration of certain aspects and embodiments of the present invention and are not intended to limit the invention. As can be discerned, the technology herein provides a great improvement in guiding surgical discectomy outcomes, and by helping quality of life, long-term, for patients, it is foreseen that the technology will grow.EXAMPLE 1. PREFERRED SURGICAL OUTCOMES WITH INTELLIGENT SPINAL FUSION PLATES AND SPINAL CAGES

[0132] The surgery depicted in FIG. 14 is an ACDF surgery without the new technology disclosed herein, wherein vertebrae 1001 , 1010, and 1020 have little to no support and guidance because intervertebral disc 1003 has already been removed and intervertebral disc 1005 is in the process of being removed by the surgeon. After the surgery in FIG. 14, a prior art implant shown in FIG. 9 is fastened to the spine of the subject. However, it is found that the compression on a spinal cage or an intervertebral space is not correct. Then, the devices shown in FIG. 12 and in FIG. 13 are tried, and the same problems are found to occur. Then, in this prophetic example, data sources are gathered initially from three databases: 1) normal subjects (with no spine defects) are analyzed to define ideal vertebrae alignments for a variety of spinal curvatures. Subjects with disc defects in 2) population data are analyzed as well to define statistical variance of age, extent of defects, nerve symptoms, and curvatures. A third database will be included with 3) anatomical parameters. Using different levels of convolutional neural networks, ML / AI (machine learning / artificial intelligence) is used to superimpose the 3 sources of data to generate ideal discectomy outcomes based on patient specific parameters and new spinal plates and cages (FIG. 1).

[0133] Various methods of manufacturing are tested, and multiple iterations are used to find the best surgical outcomes for patients (long-term). FIG. 10 shows a flowdiagram of a method 500 to make an anterior cervical plate system of the technology provided herein. At step 505, a historical patient database is obtained (from ideal ACDF surgery outcomes and non-ideal) for an algorithm training (i.e., large dataset); at step 510; one patient’s data is input for vertebrae; e.g., disc positions, non-normal spine axis, predicted normal spine axis, vertebrae incidence / angles, and any additional landmarks. At step 515, an output of planned spinal fusion plate (and cage) implant shapes, sizes, fastener positions, postbox window, and tension specifications in digital format is done. At step 520, and optional output of measurements / depth for discectomy site in digital format is done. At 525, a surgeon checks output; if needed provides adjustments to postbox window / position (human guided training). At step 526 a decision to proceed or retrain the Al (527) is made. Then at 535, a manufacture or selection of implant(s) is done. It is found the manufacture can include 3D printing. At 540, a surgery (implant) is performed.EXAMPLE 2. METHODS OF TREATING PATIENTS

[0134] After the manufacturing is done in the prophetic example above, FIG. 11 shows an example method 600 of treating a subject in need of a discectomy surgery or an ACDF (anterior cervical discectomy and fusion surgery). At 610 is obtaining a surgical assessment of the subject, whereby data from the subject’s spine with a disc defect is acquired. At step 620 is performing one or more discectomies on one or more defective discs. At step 630 is obtaining a spinal fusion plate and / or spinal cage of the technology disclosed herein. At step 640 is fastening the fixed bracket and the height adjustment bracket to the spine of the subject, wherein the postbox is positioned over the intervertebral space where the discectomy was executed. At step 650 is loosening one or more fasteners on the height adjustment bracket and moving the proximal vertebra whereby the proximal vertebra is translated superiorly; then tightening the fasteners to hold the proximal vertebra superiorly. At step 660 is inserting a spinal cage into the postbox until the two wings affixed to the cage engage with the insets of the fusion posts; and loosening the one or more fasteners on the height adjustment bracket and moving the proximal vertebra down to compress the spinal cage; and tightening the one or more fasteners to hold the cage in the compression. Various methods of treating patients are tried and then refined over time.

[0135] All patents and other publications; including literature references, issued patents, published patent applications, and co-pending patent applications; citedthroughout this application are expressly incorporated herein by reference for the purpose of describing and disclosing, for example, the methodologies described in such publications that might be used in connection with the technology described herein. These publications are provided solely for their disclosure prior to the filing date of the present application. Nothing in this regard should be construed as an admission that the inventors are not entitled to antedate such disclosure by virtue of prior invention or for any other reason. All statements as to the date or representation as to the contents of these documents is based on the information available to the applicants and does not constitute any admission as to the correctness of the dates or contents of these documents.

[0136] The foregoing written specification and figures are considered to be sufficient to enable one skilled in the art to practice the present aspects and embodiments. The present aspects and embodiments are not to be limited in scope by examples provided, since the examples are intended as a single illustration of one aspect and other functionally equivalent embodiments are within the scope of the disclosure. Various modifications in addition to those shown and described herein will become apparent to those skilled in the art from the foregoing description and fall within the scope of the appended claims. The advantages and objects described herein are not necessarily encompassed by each embodiment. Those skilled in the art will recognize or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments described herein. Such equivalents are intended to be encompassed by the following exemplary claims.REFERENCES:1IIIPAC. International Union of Pure and Applied Chemistry GoldBook. https: / / goldbook.iupac.org / .2Merriam-Webster's Online Dictionary, https: / / www.merriam-webster.com / .3Porter R. S., & Kaplan, J. L. (Eds.). The Merck manual of diagnosis and therapy (19th ed.).Merck Sharp & Dohme Corp.. 2011, (978-0-911910-19-3).4Robert S. Porter et al., (eds.). The Encyclopedia of Molecular Cell Biology and MolecularMedicine. Blackwell Science Ltd.; 1999-2012, (9783527600908).5Robert A. Meyers (ed.). Molecular Biology and Biotechnology: A Comprehensive DeskReference. VCH Publishers, Inc.; 1995, (1-56081-569-8).6Luttmann Werner. Immunology. Elsevier; 2006,7Kenneth Murphy Allan Mowat, Casey Weaver (eds.). Janeway's Immunobiology. Taylor &Francis Limited; 2014, (9780815345305).8Krebs Jocelyn E., et al. Lewin's genes XI. 11th ed. Burlington, Mass.: Jones & BartlettLearning; 2014, (1449659055).Green Michael R. Molecular cloning : a laboratory manual / Michael R. Green, JosephSambrook. Cold Spring Harbor, N.Y: Cold Spring Harbor Laboratory Press; 2012, (1936113414). Davis et al. Basic Methods in Molecular Biology. Elsevier Science Publishing, Inc.; 2012,(044460149X). Jon Lorsch (ed.). Laboratory Methods in Enzymology: DNA. Elsevier; 2013,(0124199542). Frederick M. Ausubel (ed.). Current Protocols in Molecular Biology (CPMB). John Wiley and Sons 2014, (9780471503385). John E. Coligan (ed.). Current Protocols in Protein Science (CPPS). John Wiley andSons, Inc.; 2005, John E. Coligan ADA M Kruisbeek, David H Margulies, Ethan M Shevach, Warren Strobe,(eds.) Current Protocols in Immunology (CPI). John Wiley and Sons, Inc.; 2003, (9780471142737).

Claims

WHAT IS CLAIMED IS:1 . A spinal fusion plate for use in an anterior discectomy surgery to remove an intervertebral disc from a subject in need thereof, the spinal fusion plate comprising:A) a fixed bracket positioned over a vertebra of the subject, the bracket including one or more fastener holes; each hole operative to accept a fastener through the fixed bracket and into the vertebra of the subject; wherein the fastener fits into the one or more holes and prevents a substantial movement of the bracket, and whereby the fixed bracket is thus affixed to the vertebra;B) two fusion posts extending away from the fixed bracket along the spine of the subject and fusing to a height adjustment bracket that is positioned over a proximal vertebra of the subject; the two fusion posts defining a space between the two posts along with a space or a postbox between the fixed bracket and the height adjustment bracket; the two fusion posts each including an inset operative to hold a wing of a spinal cage at the posts when a spinal cage with wings is inserted into the postbox; andC) the height adjustment bracket including one or more fastener holes, each hole operative to accept a fastener through the adjustment bracket and in the proximal vertebra of the subject, wherein each of the one or more holes allows a sliding to and fro of the proximal vertebra within the postbox when the fastener is loosened and each hole immobilizes the proximal vertebra when the fastener is tightened; wherein the spinal fusion plate is configured as a precision guided surgical implant for use in a discectomy surgery by a surgeon attaching the fixed bracket and the adjustment bracket to two adjacent vertebrae, loosening a fastener on the adjustment plate, moving the proximal vertebra, and tightening the fastener on the adjustment plate.

2. The spinal fusion plate of claim 1 , further comprising a spinal cage including two anti-protrusion wings, one wing disposed at one corner of the cage and the other wing disposed at an opposite corner, both wings capable of engaging the insets of the two fusion posts when the cage is inserted into the postbox; and wherein the engaging stops a further insertion of the cage into the spine of the subject.

3. The spinal fusion plate of claim 2, wherein the engaging of the wings with the insets prevents an excessive posterior displacement of the spinal cage into the subject’s spinal canal.

4. The spinal fusion plate of claim 1 , further comprising two additional fusion posts extending along the spine of the subject on the side of the height adjustment bracket opposite the fixed bracket; the two additional posts extending to a second height adjustment bracket; the two additional fusion posts defining a space between the two additional posts along with a second space or a second postbox between the height adjustment bracket and the second height adjustment bracket; the two additional fusion posts each including an inset operative to hold a wing of a second spinal cage at the posts when a second spinal cage with wings is inserted into the second postbox; and wherein the second height adjustment bracket is operative to be affixed to a vertebra that is adjacent to the proximal vertebra of the subject.

5. The spinal fusion plate of claim 1 , wherein the fixed bracket has an elliptical curvature or a curvature to follow an outer, anterior curvature of the vertebra to which the bracket is affixed.

6. The spinal fusion plate of claim 1 , wherein the height adjustment bracket has an elliptical curvature or a curvature to follow an outer, anterior curvature of the vertebra to which the bracket is affixed.

7. The spinal fusion plate of claim 4, wherein the second height adjustment bracket has an elliptical curvature or a curvature to follow an outer, anterior curvature of the vertebra to which the bracket is affixed.

8. The spinal fusion plate of claim 1 , wherein the one or more fastener holes in the fixed bracket include round screw holes.

9. The spinal fusion plate of claim 1 , wherein the one or more fastener holes in the height adjustment bracket are configured as oval screw holes or as sliding screw holes.

10. The spinal fusion plate of claim 1 , wherein the postbox includes a portion of the vertebra and a portion of the proximal vertebra visible from the postbox when the spinal fusion plate is affixed to the spine of the subject.11 . The spinal fusion plate of claim 1 , further comprising one or more screw locks at or near on or more fastener holes, the one or more screw locks operative to prevent a screw from loosening after the screw has been tightened into a fastener hole.

12. The spinal fusion plate of claim 1 , wherein the spinal fusion plate is capable of being affixed to the spine of the subject after a discectomy has been performed; and wherein the postbox of the spinal fusion plate is positioned over the area where the discectomy was performed, enabling a view of the intervertebral space where the disc has been removed.

13. The spinal fusion plate of claim 1 , wherein the spinal fusion plate is capable of being affixed to the spine of the subject before a discectomy has been performed, allowing the discectomy to be executed through the postbox or space, allowing the proximal vertebra to be moved after the discectomy, then allowing the proximal vertebra to be fixed in position after an insertion of a spinal cage through the postbox.

14. The spinal fusion plate of claim 1 , whereupon when one or more fasteners are loosened on the height adjustment bracket, a spreader can be used to translate the proximal vertebra superiorly and the one or more fasteners are then tightened to hold the proximal vertebra superiorly.

15. The spinal fusion plate of claim 14, whereafter when the proximal vertebra is translated superiorly and held, a spinal cage with wings on two opposite comers is inserted into the postbox until the wings engage with the insets of the two fusion posts.

16. The spinal fusion plate of claim 15, wherein the one or more fasteners are loosened to allow for a movement of the proximal vertebra towards the spinal cage, allowing for a compression of the spinal cage between the vertebra and the proximalvertebra; whereafter the one or more fasteners are re-tightened to hold the spinal cage in the compression.

17. The spinal fusion plate of claim 1 , wherein the spinal cage further comprises spinal cage fastener positions or screw holes operative to further hold the spinal cage in a position in the subject’s intervertebral space.

18. The spinal fusion plate of claim 1 , further comprising one or more markings on an anterior surface or on a surface of the plate and / or the cage; each of the one or more markings indicative of a position for a surgeon to perform a discectomy, a position for the cage to be mounted to a vertebra, a position for a fastener to be moved to or for a vertebra to be moved to, an alignment position, a position of a rotation, or a combination thereof.

19. The spinal fusion plate of claim 1 , wherein the plate includes a biocompatible material comprising stainless steel, a cobalt base alloy, a bio-ceramic, a titanium alloy, a pure titanium, a composite material, a non-resorbable polymers, a bioresorbable polymer, or a combination thereof; and / or wherein the spinal cage includes a biocompatible material comprising stainless steel, a cobalt base alloy, a bio-ceramic, a titanium alloy, a pure titanium, a composite material, a non-resorbable polymers, a bioresorbable polymer, or a combination thereof.

20. The spinal fusion plate of claim 1 , wherein the cage comprises a width in a range from about 5 mm to about 20 mm, in a range from about 10 mm to about 15 mm, or in a range from about 12 mm to about 13 mm.21 . The spinal fusion plate of claim 1 , wherein the plate comprises a thickness in a range from about 0.5 mm to about 5 mm, in a range from about 1 mm to about 3 mm, or in a range from about 1 .4 mm to about 2.4 mm.

22. The spinal fusion plate of claim 1 , further comprising wherein one or more fastener holes are omitted and an adhesive is utilized to fix the bracket to the vertebra at or near the location where the one or more fastener holes are omitted.

23. A method of treating a subject in need of an anterior discectomy surgery, the method comprising the steps of:(1) obtaining a surgical assessment of the subject, whereby data from the subject’s spine with a disc defect is acquired;(2) performing one or more discectomies on one or more defective discs;(3) obtaining a spinal fusion plate comprising:A) a fixed bracket positioned over a vertebra of the subject, the bracket including one or more fastener holes; each hole operative to accept a fastener through the fixed bracket and into the vertebra of the subject; wherein the fastener fits into the one or more holes and prevents a substantial movement of the bracket, and whereby the fixed bracket is thus affixed to the vertebra;B) two fusion posts extending away from the fixed bracket along the spine of the subject and fusing to a height adjustment bracket that is positioned over a proximal vertebra of the subject; the two fusion posts defining a space between the two posts along with a space or a postbox between the fixed bracket and the height adjustment bracket; the two fusion posts each including an inset operative to hold a wing of a spinal cage at the posts when a spinal cage with wings is inserted into the postbox; andC) the height adjustment bracket including one or more fastener holes, each hole operative to accept a fastener through the adjustment bracket and in the proximal vertebra of the subject, wherein each of the one or more holes allows a sliding to and fro of the proximal vertebra within the postbox when the fastener is loosened and each hole immobilizes the proximal vertebra when the fastener is tightened;(4) fastening the fixed bracket and the height adjustment bracket to the spine of the subject, wherein the postbox is positioned over the intervertebral space where the discectomy was executed;(5) loosening one or more fasteners on the height adjustment bracket and moving the proximal vertebra whereby the proximal vertebra is translated superiorly; then tightening the fasteners to hold the proximal vertebra superiorly;(6) inserting a spinal cage into the postbox until the two wings affixed to the cage engage with the insets of the fusion posts; and(7) loosening the one or more fasteners on the height adjustment bracket and moving the proximal vertebra down to compress the spinal cage; and tightening the one or more fasteners to hold the cage in the compression.

24. The method of claim 23, wherein the engaging of the wings with the insets prevents an excessive posterior displacement of the spinal cage into the subject’s spinal canal.

25. The method of claim 23, further comprising two additional fusion posts extending along the spine of the subject on the side of the height adjustment bracket opposite the fixed bracket; the two additional posts extending to a second height adjustment bracket; the two additional fusion posts defining a space between the two additional posts along with a second space or a second postbox between the height adjustment bracket and the second height adjustment bracket; the two additional fusion posts each including an inset operative to hold a wing of a second spinal cage at the posts when a second spinal cage with wings is inserted into the second postbox; and wherein the second height adjustment bracket is operative to be affixed to a vertebra that is adjacent to the proximal vertebra of the subject, and the method further comprising the steps of:(8) fastening the second height adjustment bracket to the spine of the subject, wherein the second postbox is positioned over a second intervertebral space where a second discectomy was executed;(9) loosening one or more fasteners on the second height adjustment bracket and moving the adjacent vertebra whereby the adjacent vertebra is translated superiorly; then tightening the fasteners to hold the adjacent vertebra superiorly;(10) inserting a second spinal cage into the second postbox until two wings affixed to the second cage engage with the insets of the two additional fusion posts; and(11 ) loosening the one or more fasteners on the second height adjustment bracket and moving the adjacent vertebra down to compress the second spinal cage; then tightening the one or more fasteners to hold the second cage in the compression.

26. The method of claim 23, further comprising wherein step (4) is executed as described below, instead of the step (4) shown in claim 23:(4) fastening the fixed bracket and the height adjustment bracket to the spine of the subject, wherein the postbox is positioned over a defective disc to be removed via a discectomy and executing the discectomy by excising at least a portion of the disc through the postbox window, whereby the discectomy is executed after the fixed bracket and the height adjustment bracket are affixed to the spine of the subject.

27. The method of claim 25, further comprising wherein step (8) is executed as described below, instead of the step (8) shown in claim 25:(8) fastening the second height adjustment to the spine of the subject, wherein the second postbox is positioned over a defective disc to be removed via a discectomy and executing the discectomy by excising at least a portion of the disc through the second postbox window, whereby the discectomy is executed after the fixed bracket and the second height adjustment bracket are affixed to the spine of the subject.

28. The method of claim 25, wherein the engaging of the wings of the second spinal cage with the insets of the two additional fusion posts prevents an excessive posterior displacement of the second spinal cage into the subject’s spinal canal.

29. The method of claim 23, wherein the one or more fastener holes in the height adjustment bracket are configured as oval screw holes or as sliding screw holes.

30. The method of claim 29, wherein the loosening in steps (5) and (7) causes an ability to move a vertebra of the subject to and fro.31 . The method of claim 23 or of claim 25, further comprising the surgeon uses a spreader to translate a vertebra superiorly.

32. The method of claim 23 or of claim 25, further comprising wherein one or more fastener holes are omitted and a surgeon utilizes an to affix a bracket to the vertebra at or near the location where the one or more fastener holes are omitted.

33. The method of claim 23, further comprising one or more of the following steps of surgical planning methods are executed: one or more radiographs are loaded on a surgical planning software; a spinal fusion plate contour is planned to match a unique bone contour of the subject; a spinal cage is sized and / or shaped to match a unique intervertebral area of the subject; one or more positions of one or more fasteners are planned to fasten the spinal plate to a vertebra of the subject; a data-driven, artificial-intelligence, and / or machine-learning process is utilized to determine a size, contour, or window on the spinal fusion plate to ensure perfect execution of the surgical plan following a data established spine contour of the subject; and a screw trajectory and / or an adhesive placement is planned using overlays of one or more prototype spinal plates, robotic assistance, and / or ultrasound guidance.

34. The method of claim 23, further comprising an intraoperative verification of the spinal plate is performed including one or more of measurements of the subject’s spine and / or the spinal plate during a surgery from one or more assigned targets using radiography, fluoroscopy, computerized tomography (CT), robotics, and / or ultrasound.

35. The method of claim 23, further comprising a pre-operative surgical plan is assessed using one or more of a healthcare provider’s examination of the subject, an ultrasound, and / or a robotic assisted exam.

36. The method of claim 23, wherein one or more markings on the spinal plate are used to indicate an area to perform a discectomy, an area to mount the spinal plate to a vertebra, or an area for a fastener.

37. The method of claim 23, further comprising making one or more iterative adjustments of the spinal plate and / or to the spinal cage.

38. The method of claim 23, wherein a screw placement is provided with a positioning designed with a specific angulation to tie to the spinal plate, a fluoroscopy image, a robot, a navigation plan through a plate’s projected position in the subject’s spine, an ultrasound, and / or wherein the plate at least partially requires or dictates a screw location and orientation.

39. A method of making a spinal plate, wherein the spinal plate comprises A), B), and C):A) a fixed bracket positioned over a vertebra of the subject, the bracket including one or more fastener holes; each hole operative to accept a fastener through the fixed bracket and into the vertebra of the subject; wherein the fastener fits into the one or more holes and prevents a substantial movement of the bracket, and whereby the fixed bracket is thus affixed to the vertebra;B) two fusion posts extending away from the fixed bracket along the spine of the subject and fusing to a height adjustment bracket that is positioned over a proximal vertebra of the subject; the two fusion posts defining a space between the two posts along with a space or a postbox between the fixed bracket and the height adjustment bracket; the two fusion posts each including an inset operative to hold a wing of a spinal cage at the posts when a spinal cage with wings is inserted into the postbox; andC) the height adjustment bracket including one or more fastener holes, each hole operative to accept a fastener through the adjustment bracket and in the proximal vertebra of the subject, wherein each of the one or more holes allows a sliding to and fro of the proximal vertebra within the postbox when the fastener is loosened and each hole immobilizes the proximal vertebra when the fastener is tightened; and wherein the method is comprising the steps of:(1) in a computer system having at least a processor, software, and memory; receiving data representing a surgical assessment of a subject’s spine, including data for a disc with a defect;(2) superimposing a targeted spinal plate shape and / or size over the data;(3) adjusting the superimposed targeted spinal plate in a shape and / or size of a postbox or surgical window to achieve a fit for the subject’s spine;(4) outside of the computer system, outputting data for the adjusted plate and / or window suitable for either manufacturing a spinal plate and window and manufacturing such, or suitable for obtaining a pre-manufactured spinal plate and window;(5) providing the plate with the window or postbox for a surgery for the subject; and whereby the surgery, the plate, and the postbox window provide a planned surgical outcome and will correct the disc in the subject.

40. The method of claim 39, wherein the data representing a surgical assessment of the subject includes X-ray data, CT data, or MRI data of the disc with the defect.41 . The method of claim 39, wherein step (3) further comprises: fitting an elliptical shape of a bracket of the spinal plate to fit an anterior surface of a vertebra of the subject, fitting a longitudinal shape of the spinal plate to fit a curvature of the subject’s spine, or a combination thereof.

42. The method of claim 39, further comprising placing one or more marking one the spinal plate, and wherein the spinal plate includes one or more markings operative to indicate to a surgeon where a discectomy site is planned during the surgery, where a fastener is planned to be located, or where a spinal plate or a bracket is to be affixed to a vertebra of the subject.

43. The method of claim 39, wherein the adjusting of the plate’s size, shape, and / or postbox window is further computed using one or more artificial intelligence (Al) methods or machine learning algorithms.

44. The method of claim 39, further comprising a planning of one or more positions and / or depths of one or more fasteners or adhesions for the spinal plate to a vertebra of the subject; the one or more positions and / or depths configured to fit the vertebra of the subject.

45. The method of claim 44, wherein one or more artificial intelligence (Al) methods or machine learning algorithms are utilized to determine fastener or adhesion positions on the spinal plate.

46. The method of claim 39, further comprising generating a fastener trajectory and / or an adhesion scheme using a navigation, a robotic assistance, and / or an ultrasound input.

47. The method of claim 39, wherein step (2) is further comprising: superimposing a targeted spinal cage shape and / or size over the data.

48. The method of claim 47, wherein step (3) is further comprising: adjusting the superimposed spinal cage in a shape and / or a size of the postbox or surgical window to achieve a fit for the subject’s intervertebral space; and wherein step (4) is further comprising: outside of the computer system, outputting data for the adjusted cage suitable for either manufacturing a spinal cage and manufacturing such, or suitable for obtaining a pre-manufactured spinal cage; and wherein step (5) is further comprising: providing the spinal cage for a surgery for the subject.

49. The method of claim 39, further comprising executing a follow-up surgical assessment on the subject’s spine after a healing time, obtaining additional post- surgical data from the subject; and further comprising inputting a datum into the computer system so as to improve a future manufacturing of a future spinal plate.

50. A kit suitable for a sale, the kit comprising at least one spinal plate with a surgical window or postbox window for use in accessing an intervertebral area of a spine in a subject in need thereof, the plate comprising:A) a fixed bracket positioned over a vertebra of the subject, the bracket including one or more fastener holes; each hole operative to accept a fastener through the fixed bracket and into the vertebra of the subject; wherein the fastener fits into the one or more holes and prevents a substantial movement of the bracket, and whereby the fixed bracket is thus affixed to the vertebra;B) two fusion posts extending away from the fixed bracket along the spine of the subject and fusing to a height adjustment bracket that is positioned over a proximal vertebra of the subject; the two fusion posts defining a space between the two posts along with a space or a postbox between the fixed bracket and the height adjustment bracket; the two fusion posts each including an inset operative to hold a wing of a spinal cage at the posts when a spinal cage with wings is inserted into the postbox; andC) the height adjustment bracket including one or more fastener holes, each hole operative to accept a fastener through the adjustment bracket and in the proximal vertebra of the subject, wherein each of the one or more holes allows a sliding to and fro of the proximal vertebra within the postbox when the fastener is loosened and each hole immobilizes the proximal vertebra when the fastener is tightened; wherein the spinal plate is configured as a surgical implant for use by a surgeon as a precision guided surgical implant for use in a discectomy surgery by a surgeon attaching the fixed bracket and the adjustment bracket to two adjacent vertebrae, loosening a fastener on the adjustment plate, moving the proximal vertebra, and tightening the fastener on the adjustment plate.51 . The kit of claim 50, further comprising instructions for use in a media format of a video, instructions with illustrations, written instructions, or a combination thereof.

Images