Spinal implant system

Abstract

A spinal implant includes a receiving portion having a first arm connected to a first extension and a second arm connected to a second extension. The arms are connected to the extension via a disengagement surface. The arms include a proximal end surface, and the receptacle includes an implant receiving surface. The proximal end surface and the implant receiving surface define an implant cavity. The release surface is disposed within the implant cavity. In some embodiments, systems, spinal constructions, and methods are disclosed.

Description

Technical Field

[0001] The present disclosure relates generally to medical devices for treating musculoskeletal disorders, and more particularly to spinal implant systems and methods for treating the spine. Background Art

[0002] Spinal pathologies and disorders, such as kyphosis, scoliosis and other curvature abnormalities, degenerative disc disease, herniated discs, osteoporosis, spondylolisthesis, stenosis, tumors and fractures can be caused by factors including trauma, disease and degenerative conditions resulting from injury and aging. Spinal disorders often result in symptoms including deformity, pain, nerve damage and partial or complete loss of mobility.

[0003] Non-surgical treatments (such as medicine, rehabilitation and exercise, etc.) may be effective, but may not alleviate the symptoms associated with these conditions. The surgical treatments of these spinal conditions include correction, fusion, fixation, discectomy, laminectomy and implantable prosthesis. As part of these surgical treatments, spinal column structures including vertebral rods are generally used to provide stability for the treatment area. When healing, the rod redirects stress away from the damaged or defective area to restore proper alignment and overall support vertebral members. During surgical treatment, one or more rods and bone fasteners can be delivered to the surgical site. The rod can be attached to the outside of two or more vertebral members via fasteners. Surgical treatment can adopt surgical instruments and implants, which are manipulated to engage with the vertebra to position and align one or more vertebrae. The present disclosure describes improvements to these prior arts. Summary of the invention

[0004] In one embodiment, a spinal implant is provided. The spinal implant includes a receiving portion having a first arm connected to a first extension and a second arm connected to a second extension. The arms are connected to the extension via a breakaway surface. The arms include a proximal-most end surface, and the receiving portion includes an implant receiving surface. The proximal-most end surface and the implant receiving surface define an implant cavity. The breakaway surface is disposed within the implant cavity. In some embodiments, systems, spinal structures, and methods are disclosed.

[0005] In one embodiment, a bone fastener is provided. The bone fastener includes a receiving portion having a first arm connected to a first extension and a second arm connected to a second extension. The arms are connected to the extension via a breakaway surface. The arms include a proximal-most end surface, and the receiving portion includes an implant receiving surface. The proximal-most end surface and the implant receiving surface define an implant cavity. The breakaway surface is disposed within the implant cavity, and a threaded shaft is connectable to the receiving portion and is engageable with vertebral tissue.

[0006] In one embodiment, the spinal implant comprises a receiving portion having a first arm connected to a first extension and a second arm connected to a second extension. The arms are connected to the extension via a breakaway surface. The receiving portion comprises an inner surface having a selected threaded configuration extending along at least a portion of the arm and the extension, the breakaway surface comprising a spiral configuration and aligned with the threaded configuration. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The present disclosure will become more apparent through the detailed description of the following drawings, in which:

[0008] Figure 1 is a plan view of components of one embodiment of a spinal implant system according to the principles of the present disclosure;

[0009] Figure 2 yes Figure 1 a plan view of the assembly shown, with the parts separated;

[0010] Figure 3 yes Figure 1 a cross-sectional view of a receiving portion component of the illustrated system;

[0011] Figure 4 yes Figure 1 a perspective view of the receiving portion component shown;

[0012] Figure 5 yes Figure 1 An exploded view of the receiving portion components of the illustrated system;

[0013] Figure 6 yes Figure 1 a cross-sectional view of a receiving portion component of the illustrated system;

[0014] Figure 7 yes Figure 6 An exploded view of the components shown in detail A;

[0015] Figure 8 yes Figure 6 An exploded view of the components shown in detail B;

[0016] Fig. 9 yes Figure 1 a side view of components of the illustrated system;

[0017] Fig.10 yes Figure 1 a perspective view of components of the illustrated system;

[0018] Fig.11 yes Fig.10 An exploded view of the components shown in;

[0019] Fig.12 yes Figure 1 a side view of components of the illustrated system;

[0020] Fig.13 yes Figure 1 a perspective view of components of the illustrated system;

[0021] Fig.14 yes Figure 1 A side view of components of the system shown in;

[0022] Fig.15 yes Figure 1 a plan view of the components of the system shown;

[0023] Fig.16 is a perspective view of components of one embodiment of a spinal implant system according to the principles of the present disclosure;

[0024] Fig.17 is a perspective view of components of one embodiment of a spinal implant system according to the principles of the present disclosure;

[0025] Fig.18 is a perspective view of components of one embodiment of a spinal implant system according to the principles of the present disclosure;

[0026] Fig.19 is a perspective view of components of one embodiment of a spinal implant system configured with an anatomical structure in accordance with the principles of the present disclosure;

[0027] Fig. 20 is a perspective view of components of one embodiment of a spinal implant system configured with an anatomical structure in accordance with the principles of the present disclosure;

[0028] Fig.21 is a perspective view of components of one embodiment of a spinal implant system configured with an anatomical structure in accordance with the principles of the present disclosure;

[0029] Fig. 22 is a plan view of components of one embodiment of a spinal implant system according to the principles of the present disclosure;

[0030] Fig.23 yes Fig. 22 a cross-sectional view of a receiving portion component of the illustrated system;

[0031] Fig.24 yes Fig. 22 a perspective view of a receiving portion component of the illustrated system;

[0032] Fig.25 yes Fig. 22 An exploded view of the receiving portion components of the illustrated system;

[0033] Fig.26 yes Fig. 22 a cross-sectional view of a receiving portion component of the illustrated system;

[0034] Fig. 27 yes Fig.26 An exploded view of the components shown in detail C;

[0035] Fig.28 yes Fig.26 An exploded view of the components shown in detail D;

[0036] Fig.29 is a plan view of components of one embodiment of a spinal implant system according to the principles of the present disclosure;

[0037] Fig.30 yes Fig.29 a cross-sectional view of components of the system shown;

[0038] Fig.31 is a perspective view of components of one embodiment of a spinal implant system configured with an anatomical structure in accordance with the principles of the present disclosure;

[0039] Fig.32 is a perspective view of components of one embodiment of a spinal implant system configured with an anatomical structure in accordance with the principles of the present disclosure;

[0040] Fig.33 is a perspective view of components of one embodiment of a spinal implant system configured with an anatomical structure in accordance with the principles of the present disclosure;

[0041] Fig.34 is a perspective view of components of one embodiment of a spinal implant system configured with an anatomical structure in accordance with the principles of the present disclosure;

[0042] Fig.35 is a perspective view of components of one embodiment of a spinal implant system configured with an anatomical structure in accordance with the principles of the present disclosure;

[0043] Fig.36 is a perspective view of components of one embodiment of a spinal implant system configured with an anatomical structure in accordance with the principles of the present disclosure;

[0044] Fig.37 is a perspective view of components of one embodiment of a spinal implant system configured with an anatomical structure in accordance with the principles of the present disclosure;

[0045] Fig.38 is a perspective view of components of one embodiment of a spinal implant system configured with an anatomical structure in accordance with the principles of the present disclosure;

[0046] Fig.39is a perspective view of components of one embodiment of a spinal implant system configured with an anatomical structure in accordance with the principles of the present disclosure;

[0047] Fig.40 is an image of components of one embodiment of a spinal implant system configured with a vertebra according to the principles of the present disclosure;

[0048] Fig.41 is a top view of components of one embodiment of a spinal implant system configured with an anatomical structure in accordance with the principles of the present disclosure;

[0049] Fig.42 is an image of components of one embodiment of a spinal implant system configured with a vertebra according to the principles of the present disclosure;

[0050] Fig.43 is an image of components of one embodiment of a spinal implant system configured with a vertebra according to the principles of the present disclosure;

[0051] Fig.44 is an image of components of one embodiment of a spinal implant system configured with a vertebra according to the principles of the present disclosure;

[0052] Fig.45 is an image of components of one embodiment of a spinal implant system configured with a vertebra according to the principles of the present disclosure;

[0053] Fig.46 is an image of components of one embodiment of a spinal implant system configured with a vertebra according to the principles of the present disclosure;

[0054] Fig.47 is an image of components of one embodiment of a spinal implant system configured with a vertebra according to the principles of the present disclosure;

[0055] Fig.48 is an image of components of one embodiment of a spinal implant system configured with a vertebra according to the principles of the present disclosure;

[0056] Fig.49 is an image of components of one embodiment of a spinal implant system configured with a vertebra according to the principles of the present disclosure;

[0057] Fig.50 is an image of components of one embodiment of a spinal implant system configured with a vertebra according to the principles of the present disclosure;

[0058] Fig.51 is an image of components of one embodiment of a spinal implant system configured with a vertebra according to the principles of the present disclosure;

[0059] Fig.52is an image of components of one embodiment of a spinal implant system configured with a vertebra according to the principles of the present disclosure;

[0060] Fig.53 is an image of components of one embodiment of a spinal implant system configured with a vertebra according to the principles of the present disclosure;

[0061] Fig.54 is an image of components of one embodiment of a spinal implant system configured with a vertebra according to the principles of the present disclosure;

[0062] Fig.55 is an image of components of one embodiment of a spinal implant system configured with a vertebra according to the principles of the present disclosure; and

[0063] Fig.56 is an image of components of one embodiment of a spinal implant system configured with a vertebra according to the principles of the present disclosure; DETAILED DESCRIPTION

[0064] Exemplary embodiments of the disclosed surgical systems and related methods of use are discussed in terms of medical devices for treating musculoskeletal disorders, and more specifically, in terms of spinal implant systems and methods for treating the spine. In some embodiments, the surgical system of the present disclosure includes a spinal implant comprising a repositioned multiaxial bone fastener having an extension, such as an extension piece, which is constructed to be disengaged (e.g., broken) from a receiving portion of the bone fastener to achieve minimally invasive surgical procedures. In some embodiments, the extension is broken from the receiving portion via a bottom cut. In some embodiments, the extension is broken from the receiving portion via a spiral cut surface aligned with the internal thread of the receiving portion. In some embodiments, the surgical system of the present disclosure is implemented in a method for minimally invasive cervical spine surgery, the method comprising navigation and / or robotics to enable a surgeon to precisely fix a bone fastener at a surgical site, the bone fastener comprising a pedicle bone fastener and / or a lateral mass bone fastener. In some embodiments, the systems and methods of the present disclosure include medical devices that include surgical instruments and implants that are employed in surgical treatments of, for example, the cervical, thoracic, lumbar, and / or sacral regions of the spine, as described herein.

[0065] In some embodiments, the surgical system of the present disclosure includes a spinal implant including a repositioned polyaxial bone fastener having a pair of extensions. In some embodiments, the surgical system of the present disclosure includes a spinal rod configured to be fixed with a bone fastener. In some embodiments, the extension facilitates the use of the bone fastener to capture the spinal rod. In some embodiments, the extension is configured to break from the receiving portion of the bone fastener after the spinal rod is fixed. In some embodiments, the extension breaks from the receiving portion via a selected surface geometry to control the location and consistency of the break, thereby minimizing damage to surrounding tissue at the surgical site.

[0066] In some embodiments, the surgical system of the present disclosure includes a repositioning polyaxial bone fastener, which is configured for surgical procedures including minimally invasive spinal deformity surgery. In some embodiments, the bone fastener is used as a component of a posterior configuration. In some embodiments, the surgical system of the present disclosure includes a spinal rod, which is configured to be fixed with a bone fastener. In some embodiments, the spinal rod is configured to be fixed with an implant receiving surface of the bone fastener. In some embodiments, the implant receiving surface includes a portion of a saddle. In some embodiments, a pair of extensions connected to the receiving portion of the bone fastener are configured to capture the spinal rod with the bone fastener. In some embodiments, the fixing screw is configured to fix the spinal rod with the bone fastener. In some embodiments, the extension is configured to break from the receiving portion after the spinal rod is fixed with the bone fastener. In some embodiments, the extension breaks at a recessed surface. In some embodiments, the recessed surface includes an undercut. In some embodiments, the recessed surface includes a spiral configuration. In some embodiments, the recessed surface is configured to reduce the amount of soft tissue around the surgical site exposed to the fractured recessed surface. In some embodiments, reducing soft tissue exposure to the fracture surface can reduce long-term deleterious effects, for example, in the cervical spine where the screw-to-skin distance is shallow. In some embodiments, the concave surface is a selected geometry to control the location and consistency of the resulting fracture surface, thereby minimizing negative effects on surrounding soft tissue.

[0067] In some embodiments, the surgical system of the present disclosure includes a bone fastener, which includes a cervical vertebra reduction multi-axial bone fastener. In some embodiments, the bone fastener is constructed to be fixed to the occipital bone and one or more vertebrae (including the T3 vertebra). In some embodiments, the surgical system of the present disclosure includes multiple multi-axial bone fasteners, multiple hooks, multiple cross connectors, multiple rod-to-rod connectors and / or multiple spinal rods. In some embodiments, the spinal rod has a selected size, including 3.2mm and / or 3.5mm. In some embodiments, the spinal rod has a selected size, including 4.75mm, 5.5mm and / or 6.0mm. In some embodiments, the spinal rod is made of titanium alloy and / or cobalt-chromium alloy.

[0068] In some embodiments, the surgical system of the present disclosure includes a cervical vertebra reduction polyaxial bone fastener. In some embodiments, the bone fastener includes a pair of extensions. In some embodiments, the extension is configured to break from the surface of the receiving portion of the bone fastener (e.g., a fracture surface including a bottom cut) via a selected geometry. In some embodiments, the bottom cut is recessed below the shoulder of the receiving portion, such as below the saddle or crown of the bone fastener. In some embodiments, the bottom cut forms a shield around the periphery of the surface, which is formed when the extension breaks and reduces potential contact and / or damage to the surrounding soft tissue. In some embodiments, the bottom cut includes an internal thread and a spiral cut on the outer surface of the receiving portion, which is aligned with a specific thread on the inner surface of the receiving portion to produce a shear point. In some embodiments, the spiral cut can be implemented as a visual inspection of the user and is a low-cost approach to promote repeatable fracture areas on the bone fastener. In some embodiments, the shear point includes a shear ring. In some embodiments, the shear point is configured to facilitate the removal of the extension when a force is applied to the extension. In some embodiments, the force is manually applied to the extension. In some embodiments, the formation of shear points can be applied to cervical bone fasteners and can be applied to bone fasteners implemented in thoracolumbar deformity surgery. In some embodiments, the concave shoulder and spiral cut are made of forged 90% titanium, 6% aluminum, 4% vanadium, 0.25% (max) iron and 0.2% (max) oxygen (Ti-6AI-4V). In some embodiments, all or a portion of the bone fastener is made of Ti-6AI-4V. In some embodiments, the bone fastener is manufactured by 3D printing. In some embodiments, the bone fastener is manufactured by 3D printing using Ti-6AI-4V powder.

[0069] In some embodiments, a method for using a surgical system including a polyaxial bone fastener is provided. In some embodiments, the method includes minimally invasive cervical spine surgery, which includes navigation and robotics, enabling surgeons to accurately fix bone fasteners at the surgical site, the bone fasteners including pedicle bone fasteners and lateral mass bone fasteners. In some embodiments, the bone fastener system includes pedicle bone fasteners. In some embodiments, the bone fasteners include cervical vertebra reduction bone fasteners, which include extensions connected to extensions. In some embodiments, the bone fasteners are connected to extensions, caps, and selected instruments to achieve minimally invasive thoracolumbar spine surgery. In some embodiments, the selected instruments include surgical drivers. In some embodiments, the driver is constructed to fix the bone fasteners at the surgical site. In some embodiments, the surgical system is constructed to fix the occipital and T3 vertebrae.

[0070] In some embodiments, a method for minimally invasive surgical procedures is provided, the method comprising a surgical system of the present disclosure as described herein. In some embodiments, the method comprises the step of attaching an extension to the extension. In some embodiments, attaching the extension to the extension enables the surgeon to use navigation to locate the bone fastener, thereby creating a small incision and being able to approach the bone fastener under the patient's skin. In some embodiments, the method comprises the step of engaging a cap to the top of the extension. In some embodiments, engaging the cap to the top of the extension provides stability, and the cap is constructed to align the instrument with the bone fastener thread. In some embodiments, the method comprises the step of inserting the bone fastener attached to the extension and the cap into a surgical site. In some embodiments, the surgical site comprises a cervical vertebra each having a pedicle. In some embodiments, the method comprises the step of engaging a spinal rod with the extension. In some embodiments, the method comprises the step of translating a set screw through the cap and the extension using a surgical instrument, and entering the receiving portion of the bone fastener to engage the spinal rod with the bone fastener. In some embodiments, the surgical instrument includes a driver. In some embodiments, the method includes the step of tightening the set screw in the receiving portion to secure the spinal rod with the bone fastener. In some embodiments, the method includes the step of removing the cap from the extension. In some embodiments, the method includes the step of sliding the instrument over the extension and the extension and shaking the instrument to disengage the extension from the bone fastener. In some embodiments, the fracture of the extension is made so that when the extension fractures, the top of the receiving portion is flat and the fracture portion is located below the top of the receiving portion.

[0071] In some embodiments, the surgical system of the present disclosure can be used to treat spinal patients, such as degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumors and fractures. In some embodiments, the surgical system of the present disclosure can be used together with other skeletons and bone-related applications, including those applications associated with diagnosis and therapy. In some embodiments, the disclosed surgical system can be used alternatively in surgical treatments in which the patient is in a prone or supine position, and / or various surgical approaches (including anterior, posterior, posterior midline, direct lateral, posterior lateral, and / or anterolateral approaches) are used to reach the spine, and to reach other body regions. The surgical system of the present disclosure can also be used alternatively with the procedures for treating the lumbar vertebrae, cervical vertebrae, thoracic vertebrae, sacrum and pelvic regions of the spine. The surgical system of the present disclosure can also be used on animals, bone models and other inanimate substrates, such as for training, testing and demonstration.

[0072] The surgical system of the present disclosure can be more easily understood by the following detailed description of the embodiments in conjunction with the accompanying drawings that form a part of the present disclosure. It should be understood that the present application is not limited to the specific equipment, methods, conditions or parameters described and / or shown herein, and the terms used herein are only for describing specific embodiments by way of example, rather than for limiting. In some embodiments, as used in the specification, and including the appended claims, the singular forms "a / an" and "the" include plural numbers, and references to specific numerical values ​​include at least the specific value, unless the context clearly stipulates otherwise. The range can be expressed as "about" or "approximately" a specific value and / or "about" or "approximately" another specific value in this article. When expressing such a range, another embodiment includes from one specific value and / or to another specific value. Similarly, when a value is expressed as an approximate value by using the antecedent "about", it should be understood that a specific value forms another embodiment. It should also be understood that all spatial references (e.g., horizontal, vertical, top, upper, lower, bottom, left and right) are only for illustrative purposes and can be changed within the scope of the present disclosure. For example, references to "upper" and "lower" are relative and are used only in the context of another situation, and are not necessarily "upper" and "lower".

[0073] As used in this specification and the appended claims, "treatment" of a disease or condition means performing a procedure that may include administering one or more drugs to a patient (human, normal or other human or other mammal), using an implantable device, and / or using an instrument for treating the disease (e.g., a microdiscectomy instrument for removing a portion of a bulging or herniated disc and / or bone spurs) to alleviate the signs or symptoms of the disease or condition. Relief may occur before the signs or symptoms of the disease or condition appear, or after they appear. Thus, treatment includes preventing a disease or adverse condition (e.g., preventing a patient who may be susceptible to the disease but has not yet been diagnosed with the disease from developing the disease). In addition, treatment does not require complete relief of signs or symptoms, does not require a cure, and specifically includes procedures that have only a minimal effect on the patient. Treatment may include inhibiting the disease, such as stopping its development, or alleviating the disease, such as causing the disease to regress. For example, treatment may include reducing acute or chronic inflammation; alleviating and relieving pain and promoting the regrowth of new ligaments, bones and other tissues; as an adjunct to surgery; and / or any repair procedure. In some embodiments, unless otherwise expressly indicated, the term "tissue" as used in the specification and including the appended claims includes soft tissue, ligaments, tendons, cartilage, and / or bone.

[0074] The following discussion includes a description of surgical systems including spinal implants, related components, and methods of using the surgical systems according to the principles of the present disclosure. Alternative embodiments are also disclosed. Reference is made in detail to the exemplary embodiments of the present disclosure illustrated in the accompanying drawings. Figures 1 to 15 , illustrative components of a surgical system, such as a spinal implant system 10, are shown.

[0075] The components of the spinal implant system 10 can be made of bio-acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics, and bone materials and / or composites thereof. For example, the components of the spinal implant system 10 can be made individually or collectively of materials such as stainless steel alloys, aluminum, commercially pure titanium, titanium alloys, grade 5 titanium, superelastic titanium alloys, cobalt-chromium alloys, superelastic metal alloys (e.g., Nitinol, superelastic metals such as GUM, etc.), and superelastic metals such as PTFE, PTFE, and PTFE. ), ceramics and composites thereof (such as calcium phosphate (e.g., SKELITE TM ), thermoplastics (such as polyaryletherketone (PAEK), including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO 4Polymeric rubber, polyethylene terephthalate (PET)), fabrics, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubber, polyolefin rubber, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermosetting elastomers, elastomeric composites, rigid polymers (including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy resins), bone materials (including autologous transplants, allogeneic transplants, xenografts or transgenic cortical bone and / or cortical spongy bone and tissue growth or differentiation factors), partially absorbable materials (e.g., composites of metal and calcium-based ceramics, composites of PEEK and calcium-based ceramics, composites of PEEK and absorbable polymers), fully absorbable materials (e.g., calcium-based ceramics such as calcium phosphate, tricalcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate or other absorbable polymers such as polylactide, polyglycolide, polytyrosine carbonate, polycaprolactone) and combinations thereof.

[0076] The various components of spinal implant system 10 may have a material composite including the above-mentioned materials to achieve various desired properties, such as strength, rigidity, elasticity, compliance, biomechanical properties, durability, and radiolucency or imaging preferences. The components of spinal implant system 10 may also be made of heterogeneous materials (such as a combination of two or more of the above-mentioned materials) individually or collectively. The components of spinal implant system 10 may be integrally formed, integrally connected or include fastening elements and / or instruments, as described herein.

[0077] Spinal implant system 10, for example, is used together with full open surgical procedures, minimally invasive surgical procedures (comprising percutaneous techniques) and small incision surgical techniques, to deliver and introduce instrument and / or spinal implant (for example, bone fastener) at the surgical site (comprising, for example, spinal column) of patient.In some embodiments, spinal implant may comprise one or more parts (for example, intervertebral device, intervertebral fusion cage, bone fastener, spinal rod, tether, connector, plate and / or bone graft) of one or more spinal structures, and can be adopted together with various surgical procedures (comprising the surgical treatment to the cervical region, thoracic region, lumbar region and / or sacral region of spinal column).

[0078] The spinal implant system 10 includes a spinal implant, such as a bone fastener 12, such as Figure 1 and Figure 2 The bone fastener 12 is configured for fixation with a surgical site that includes vertebral tissue and is configured to receive a spinal implant (eg, a spinal rod 14). The bone fastener 12 extends between ends 16, 18 and defines a longitudinal axis AA.

[0079] The bone fastener 12 includes a receiving portion 20 extending between a proximal end 22 and a distal end 24. The end 22 includes an arm 26 and an arm 28. The arms 26, 28 each extend parallel to the axis AA. The arms 26, 28 each include an arcuate outer surface extending between a pair of side surfaces. At least one of the outer and side surfaces of the arms 26, 28 has at least one recess or cavity 30, 32 therein that is configured to receive an insertion tool, a compression instrument, and / or an instrument for inserting and tensioning the bone fastener 12.

[0080] like Figure 5 As shown, arm 26 includes a proximal-most end surface 34 configured for connection with extension 36. Arm 28 includes a proximal-most end surface 38 configured for connection with extension 40. Proximal-most end surfaces 34, 38 define a transverse plane BB ( Figure 2 ). The extensions 36, 40 each include an arcuate outer surface extending between a pair of side surfaces. At least one of the outer and side surfaces of the extensions 36, 40 has at least one recess or cavity 39, 41 therein that is configured to receive an insertion tool, an extension tab, a compression instrument, and / or an instrument for inserting and tensioning the bone fastener 12. In some embodiments, the extensions 36, 40 include an extension tab.

[0081] Receiving portion 20 includes an implant receiving surface 42. Implant receiving surface 42 is configured to engage with a surface of spinal rod 14. Implant receiving surface 42 includes saddle 70, as described herein. Proximal-most end surfaces 34, 38 and implant receiving surface 42 define an implant cavity 44. In some embodiments, cavity 44 can have various cross-sectional configurations, such as oval, elliptical, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, deformable, and / or conical.

[0082] The arm 26 is connected to the extension 36 via the breakaway surface 46, and the arm 28 is connected to the extension 40 via the breakaway surface 48. The breakaway surfaces 46, 48 are disposed within the cavity 44, and at least a portion of the breakaway surfaces 46 and 48 are axially spaced apart from the transverse plane BB. In some embodiments, the breakaway surfaces 46, 48 are connected to the proximal end surfaces 34, 38. In some embodiments, the breakaway surfaces 46, 48 are spaced apart and separated from the proximal end surfaces 34, 38. The breakaway surfaces 46, 48 are configured to break and separate under a predetermined force or torque limit, as described herein. The breakaway surfaces 46, 48 are configured to break and separate from the receiving portion 20 to achieve the minimally invasive surgical procedures described herein. The breakaway surfaces 46, 48 are configured to control the position and consistency of the resulting fracture surface, thereby minimizing the negative impact on the soft tissue surrounding the bone fastener 12.

[0083] like Figures 3 to 7 As shown, arm 26 defines a proximal shoulder 50 including proximal-most end surface 34, and arm 28 defines a proximal shoulder 52 including proximal-most end surface 38. Breakaway surface 46 includes bottom cutout 54 that is recessed into proximal shoulder 50; and breakaway surface 48 includes bottom cutout 56 that is recessed into proximal shoulder 52. Bottom cutouts 54, 56 are configured to form a shield around the perimeter of shoulders 50, 52 when extensions 36, 40 break and separate from receiving portion 20, thereby reducing potential contact and / or damage to soft tissue surrounding bone fastener 12. In some embodiments, as Figure 7 As shown, a portion of the extensions 36, 40 has an angle α1, and the bottom cuts 54, 56 have an angle α2. In some embodiments, the angle α1 includes an angle in the range of 10 degrees to 30 degrees relative to the longitudinal axis AA. In some embodiments, the angle α2 includes an angle in the range of 60 to 90 degrees relative to the longitudinal axis AA. In some embodiments, the angle α1 includes an angle in the range of 20 degrees and the angle α2 includes an angle of 75 degrees.

[0084] like Fig.11 As shown, the breakaway surface 46 includes a circumferential wall 58 that is configured to connect the arm 26 to the extension 36; and the breakaway surface 48 includes a circumferential wall 60 that is configured to connect the arm 28 to the extension 40. The walls 58, 60 are made of a fractured material and / or a brittle material so that manipulation of the extensions 36, 40 can break and separate the extensions 36, 40 from the arms 26, 28 under a predetermined force and / or torque limit, as described herein. The walls 58, 60 have a reduced thickness relative to the extensions 36, 40 to facilitate breaking and separation. In some embodiments, the walls 58, 60 form a shear point (e.g., a shear ring) to facilitate breaking and separation.

[0085] The breakaway surfaces 46, 48 are configured to break and separate under a predetermined force or torque limit. In some embodiments, the predetermined force or torque limit includes a range of about 2Nm to 8Nm. In some embodiments, the extensions 36, 40 and arms 26, 28 may have the same or alternative cross-sectional configurations, may be made of homogenous materials or heterogeneously made of different materials, and / or may alternatively be formed of materials having a greater degree, property, or attribute of plastic deformability, brittle properties, and / or breakability to facilitate the breakage and separation of the extensions 36, 40.

[0086] like Figure 6As shown, the proximal-most end surfaces 34, 38 define a proximal boundary 62 of the cavity 44, and the implant receiving surface 42 defines a distal boundary 64 of the cavity 44. The receiving portion 20 includes an internally threaded surface 66, 68 extending along at least a portion of the arms 26, 28 and the extensions 36, 40. The internally threaded surfaces 66, 68 are configured for engagement with a set screw (not shown).

[0087] Implant receiving surface 42 includes Figure 12 to Figure 13 The saddle 70 is shown, which is configured to receive the spinal rod 14. The saddle 70 includes an end 72 and an end 74. The end 72 is configured to receive the spinal rod 14, and the end 74 is configured to engage the head 102 of the shaft 100 of the bone fastener 12, as described herein. The end 74 includes segments 76, 78, which are configured to form a profile with the head 102.

[0088] Bone fastener 12 includes a base 80, such as Figure 14 to Figure 15 The base 80 includes a flange 82 and a ring 86, the flange being configured to be used with a Figure 6 and Figure 8 The outer surface includes an arcuate portion 87. In some embodiments, the portion 87 is configured to facilitate superangulation of the bone fastener 12. The base 80 includes an inner surface 88 configured to engage the saddle 70 and the head 102.

[0089] The shaft 100 includes a threaded portion 104 that can be connected to the receiving portion 20 and can engage with tissue (e.g., vertebral tissue). In some embodiments, the threaded portion 104 can include a single thread turn or a plurality of discrete threads. The head 102 includes a tool engagement portion 106 that is configured to engage with an engagement surgical tool or instrument, as described herein. In some embodiments, portion 106 includes a hexagonal cross-section. In some embodiments, the head 102 includes an outer surface having a planar surface or a flat portion and / or an arcuate surface.

[0090] In assembly, operation and use, similar to the systems and methods described herein, spinal implant system 10 is used together with surgical procedures (e.g., treatment of applicable conditions or injuries to the affected segments of the spine and adjacent areas in the body). In some embodiments, one or all of the components of spinal implant system 10 can be delivered or utilized as preassembled equipment, or can be assembled in situ. Spinal implant system 10 can be modified, removed or replaced in whole or in part.

[0091] In use, the patient's anatomy (including the surgical site) is imaged for treatment of a vertebra (e.g., cervical spine). In some embodiments, the patient's anatomy is imaged via an x-ray image suitable for a selected surgical procedure. In some embodiments, the spinal implant system 10 includes a surgical navigation system including a surgical navigation system sold by Medtronic Navigation, Inc., having a place of business in Louisville, Colo., USA. Imaging device.

[0092] The medical practitioner obtains access to the surgical site in any appropriate manner (such as by percutaneous incision and / or tissue retraction). In some embodiments, the spinal implant system 10 can be used for any existing surgical method or technique, which includes open surgery, micro-open surgery, minimally invasive surgery, and percutaneous surgery implantation, thereby approaching the vertebrae through a small incision or sleeve that provides a protected passage to the area. Once access to the surgical site is obtained, a specific surgical procedure can be performed to treat spinal disorders.

[0093] An incision is made in the patient and a cutting instrument (not shown) is used to create a surgical path (e.g., a minimally invasive path) that includes the pedicles of the cervical vertebrae of the patient's anatomical structure for implanting the components of the spinal implant system 10. In some embodiments, the path includes a roughly lateral to medial trajectory of the patient's anatomical structure. In some embodiments, the path includes the pedicles of the first cervical vertebrae and the lateral masses of the second cervical vertebrae. A preparation instrument (not shown) can be used to prepare the tissue surface of the vertebrae and the suction and flushing of the surgical area.

[0094] For example, in a selected vertebral segment (e.g., at least a portion of a pedicle of a vertebra), a cavity (e.g., a guide hole (not shown)) is created using a surgical instrument (e.g., a surgical drill and / or a surgical tap) to receive the shaft 100 of the bone fastener 12. The surgical instrument (e.g., a driver) is connected to the bone fastener 12, and the bone fastener 12 is engaged with the vertebra. In some embodiments, the bone fastener 12 is engaged in transarticular fixation of the first cervical vertebra and the second cervical vertebra. In some embodiments, the bone fastener 12 is engaged in transarticular fixation of the first cervical vertebra and the first thoracic vertebra.

[0095] In some embodiments, the surgical instrument includes a surgical navigation component 200 ( Fig.19), the surgical navigation component 200 generates a signal representing the position of the surgical instrument and / or bone fastener 12 relative to the surgical site. In some embodiments, during the creation of the cavity, the guide member 202 is set with the patient's anatomy. In some embodiments, the guide member 202 is constructed to be set with the surgical instrument, and the image guide 204 is oriented relative to the sensor (not shown) to convey the signal representing the position of the guide member 202. In some embodiments, the guide member 202 includes an end effector of a robotic arm. In some embodiments, the surgical navigation component 200 includes a tracking device (not shown), which includes a sensor (not shown) that receives signals and communicates with a processor (not shown) to generate data for displaying an image from a monitor (not shown). In some embodiments, the image represents the position of the guide member 202 relative to the surgical site. In some embodiments, the tracking device includes an EM tracking system, which may include a EM tracking system sold by Medtronic Navigation, Inc., having a place of business in Louisville, Colorado. AXIEM TM Navigation System. Exemplary tracking systems are also disclosed in U.S. Patent Nos. 8,057,407, 5,913,820, and 5,592,939, the entire contents of each of these references are incorporated herein by reference.

[0096] The ends 304, 306 of the extensions 300, 302 are connected to the bone fastener 12 via the extensions 36, 40. Figures 16 to 18 and Figure 20 to Figure 21 As shown. Caps 312 are disposed at ends 308, 310 of extensions 300, 302 to hold extensions 300 and 302. In some embodiments, extensions 300, 302 are configured to facilitate placement of bone fasteners 12 using navigation to form a small incision in a patient and to allow a surgeon to access bone fasteners 12 beneath the patient's skin. In some embodiments, caps 312 are configured to provide stability to extensions 300, 302, and extensions 300, 302 are configured to align instruments described herein with bone fasteners 12.

[0097] The spinal rod 14 is delivered along a surgical path to be connected with one or more bone fasteners 12. The spinal rod 14 is translated through the extensions 36, 40 of each bone fastener 12. A set screw (not shown) is translated through the cap 312 and the extensions 36, 40, and the set screw is threaded in a certain direction (e.g., a downward direction) until the spinal rod 14 is secured with the bone fastener 12. The spinal rod 14 is fully secured within the bone fastener 12, the set screw is fully tightened, and the cap 312 is removed from the extensions 300, 302. The surgical instrument 400 is engaged over the extensions 300, 302, and the extensions 36, 40 are swung back and forth, thereby breaking and separating the extensions 36, 40 from the receiving portions 20 of the bone fasteners 12. The undercuts 54 , 56 of the bone fastener 12 are configured to form a shield around the perimeter of the shoulders 50 , 52 when the extensions 36 , 40 are broken and separated from the receiver 20 , thereby reducing potential contact and / or damage to soft tissue surrounding the bone fastener 12 .

[0098] As described herein, when the operation is completed, the surgical instruments, components and non-implanted parts of the spinal implant system 10 are removed, and one or more incisions are closed. One or more of the parts of the spinal implant system 10 can be made of radiolucent materials (such as polymers). Radioactive markers may be included, which are used to identify under x-rays, fluoroscopy, CT or other imaging techniques. In some embodiments, the spinal implant system 10 may include one or more of a spinal rod, a plate, a connector and / or a bone fastener, to be used together with a single vertebral segment or multiple vertebral segments.

[0099] In some embodiments, as described herein, one or more bone fasteners can engage tissue in various orientations (e.g., in series, parallel, offset, staggered, and / or alternate vertebral segments). In some embodiments, the bone fasteners can include polyaxial screws, sagittal adjustment screws, pedicle screws, monoaxial screws, uniplane screws, facet screws, fixation screws, tissue penetrating screws, conventional screws, expansion screws, wedges, anchors, buttons, clamps, fasteners, friction fittings, compression fittings, expansion rivets, staples, nails, adhesives, posts, fixation plates, and / or posts.

[0100] In one embodiment, the spinal implant system 10 includes a medicament that can be disposed, packaged, coated, or layered within, on, or around a component and / or surface of the spinal implant system 10. In some embodiments, the medicament can include a bone growth promoting material (e.g., a bone graft) to enhance the fixation of the component and / or surface of the spinal implant system 10 to the vertebrae. In some embodiments, the medicament can include one or more therapeutic agents and / or pharmacological agents for release (including sustained release) to treat, for example, pain, inflammation, and degeneration.

[0101] In one embodiment, if Figure 22 to Figure 28 As shown, similar to the systems and methods described herein, the spinal implant system 10 includes a bone fastener 212 similar to the bone fastener 12. The bone fastener 212 is configured for fixation to a surgical site that includes vertebral tissue and is configured to receive the spinal rod 14. The bone fastener 212 extends between ends 216, 218 and defines a longitudinal axis CC.

[0102] Bone fastener 212 includes a receiving portion 220 similar to receiving portion 20 described herein. Receiving portion 220 extends between a proximal end 222 and a distal end 224. End 222 includes an arm 226 and an arm 228 similar to arms 26, 28 described herein. Arms 226, 228 each extend parallel to axis CC. Arms 226, 228 each include an arcuate outer surface extending between a pair of side surfaces. At least one of the outer and side surfaces of arms 226, 228 has at least one recess or cavity 230, 232 therein that is configured to receive an insertion tool, compression instrument, and / or instrument for inserting and tensioning bone fastener 212.

[0103] Arm 226 includes Fig.25 The arm 228 includes a proximal end 234 that is configured to connect with an extension 236 similar to the extension 36. The arm 228 includes a proximal end 238 that is configured to connect with an extension 240 similar to the extension 40. The extensions 236, 240 each include an arcuate outer surface extending between a pair of side surfaces. At least one of the outer surface and the side surface of the extensions 236, 240 has at least one recess or cavity 239, 241 therein that is configured to receive an insertion extension piece, an insertion tool, a compression instrument, and / or an instrument for inserting and tensioning the bone fastener 12. In some embodiments, the extensions 236, 240 include an extension piece.

[0104] The receiving portion 220 includes an implant receiving surface 242, similar to the implant receiving surface 42 described herein. The implant receiving surface 242 is configured to engage with a surface of the spinal rod 14. The implant receiving surface 242 includes the saddle 70 described herein. The proximal ends 234, 238 and the implant receiving surface 242 define an implant cavity 244 similar to the cavity 44 described herein.

[0105] The arm 226 is connected to the extension 236 via a breakaway surface 246 similar to the breakaway surface 46 described herein. The arm 228 is connected to the extension 240 via a breakaway surface 248 similar to the breakaway surface 48 described herein. The breakaway surfaces 246, 248 are configured to break and separate under a predetermined force or torque limit, as described herein. The breakaway surfaces 246, 248 are configured to break and separate from the receiving portion 220 to enable the minimally invasive surgical procedures described herein. The breakaway surfaces 246, 248 are configured to control the location and consistency of the resulting fracture surface, thereby minimizing the negative impact on the soft tissue surrounding the bone fastener 212.

[0106] The breakaway surfaces 246, 248 include a helical configuration and the threaded configurations of the inner surfaces 266, 268 of the receiving portion 220 are aligned so that the extensions 236, 240 can be broken and separated from the receiving portion 220, as shown. Figure 26 to Figure 27 The inner surfaces 266 , 268 extend along at least a portion of the arms 226 , 228 and the extensions 236 , 240 .

[0107] The arm 226 defines a proximal shoulder 250 including a proximal end 234, such as Fig.25 and Fig.26 As shown. Arm 228 defines a proximal shoulder 252 including proximal end 238. Breakaway surface 246 includes groove 254, and breakaway surface 248 includes groove 256. In some embodiments, grooves 254, 256 include an angle α3, such as Fig. 27 In some embodiments, angle α3 comprises an angle in the range of 40 to 90 degrees relative to the longitudinal axis CC. In some embodiments, angle α3 comprises an angle of 60 degrees.

[0108] The release surface 246 includes a spiral wall 258 configured to connect the arm 226 to the extension 236; and the release surface 248 includes a spiral wall 260 configured to connect the arm 228 to the extension 240, as shown in FIG. Fig.25 Walls 258, 260 are made of a breaking and / or brittle material such that manipulation of extensions 236, 240 may cause extensions 236 and 240 to break and separate from arms 226, 228 at recesses 254, 256 which align with the threaded configuration of inner surfaces 266, 268 of receiver 220 under a predetermined force and / or torque limit, as described herein and Figure 26 to Figure 27 The walls 258, 260 have a reduced thickness relative to the extensions 236, 240 to facilitate breaking and separation.

[0109] The breakaway surfaces 246, 248 are configured to break and separate under a predetermined force or torque limit. In some embodiments, the predetermined force or torque limit includes a range of approximately 2Nm to 8Nm. In some embodiments, the extensions 236, 240 and arms 226, 228 may have the same or alternative cross-sectional configurations, may be made of homogenous materials or heterogeneously made of different materials, and / or may alternatively be formed of materials having a greater degree, property, or attribute of plastic deformability, brittle properties, and / or breakability to facilitate the breakage and separation of the extensions 236, 240.

[0110] The implant receiving surface 242 includes a saddle 70 as described herein, which is configured to receive the spinal rod 14. The bone fastener 212 includes a base 80 and a ring 86 as described herein, which is configured to connect with the groove 284 of the receiving portion 220. In some embodiments, the base 80 can be manually engaged with the shaft 100 so that the receiving portion 220 and the shaft 100 are connected in a non-instrumented snap-fit ​​assembly.

[0111] In one embodiment, if Figure 29 to Figure 30 As shown, similar to the systems and methods described herein, the spinal implant system 10 includes a bone fastener 512 similar to the bone fastener 12. The bone fastener 512 is configured to be fixed to a surgical site that includes vertebral tissue and is configured to receive the spinal rod 14. The bone fastener 512 includes a reduction multi-axial screw. The bone fastener 512 extends between ends 516 and 518 and defines a longitudinal axis DD, as shown in FIG. Fig.29 shown.

[0112] Bone fastener 512 includes a receiving portion 520 similar to receiving portion 20 described herein. Receiving portion 520 includes an arm 526 and an arm 528 similar to arms 26, 28 described herein. Arms 526, 528 each extend parallel to axis DD. Arms 526, 528 each include an arcuate outer surface extending between a pair of side surfaces. At least one of the outer and side surfaces of arms 526, 528 has at least one recess or cavity 530, 532 therein that is configured to receive an insertion tool, compression instrument, and / or instrument for inserting and tensioning bone fastener 512.

[0113] The arm 526 includes a proximal end 534 configured to connect with an extension 536 similar to the extension 36. The arm 528 includes a proximal end 538 configured to connect with an extension 540 similar to the extension 40. The extensions 536, 540 each include an arcuate outer surface extending between a pair of side surfaces. At least one of the outer and side surfaces of the extensions 536, 540 has at least one recess or cavity 539, 541 therein configured to receive an insertion tool, a compression instrument, and / or an instrument for inserting and tensioning the bone fastener 512.

[0114] The receiving portion 520 includes an implant receiving surface 542 similar to the implant receiving surface 42 described herein. The implant receiving surface 542 is configured to engage with the surface of the spinal rod 14. The implant receiving surface 542 includes a saddle 570 similar to the saddle 70 described herein. The proximal ends 534, 538 and the implant receiving surface 542 define an implant cavity 544 similar to the cavity 44 described herein.

[0115] The arm 526 is connected to the extension 536 via a breakaway surface 546 similar to the breakaway surface 46 described herein. The arm 528 is connected to the extension 540 via a breakaway surface 548 similar to the breakaway surface 48 described herein. The breakaway surfaces 546, 548 are configured to break and separate under a predetermined force or torque limit, as described herein. The breakaway surfaces 546, 548 are configured to break and separate from the receiving portion 520 to enable the minimally invasive surgical procedures described herein. The breakaway surfaces 546, 548 are configured to control the location and consistency of the resulting fracture surface, thereby minimizing the negative impact on the soft tissue surrounding the bone fastener 512.

[0116] Arm 526 defines a proximal shoulder 550 including a proximal-most end surface 534, and arm 528 defines a proximal shoulder 552 including a proximal-most end surface 538. Breakaway surface 546 includes an undercut 554 that is recessed into proximal shoulder 550, and breakaway surface 548 includes an undercut 556 that is recessed into proximal shoulder 552. Undercuts 554, 556 are configured to form a shield around the perimeter of shoulders 550, 552 when extensions 536, 540 are broken and separated from receiver 520, thereby reducing potential contact and / or damage to soft tissue surrounding bone fastener 512.

[0117] The disengagement surface 546 includes a circumferential wall 558 similar to the wall 58 described herein, which is configured to connect the arm 526 to the extension 536; and the disengagement surface 548 includes a circumferential wall 560 similar to the wall 60 described herein, which is configured to connect the arm 528 to the extension 540.

[0118] The proximal-most end surfaces 534, 538 define a proximal boundary 562 of the cavity 544, and the implant receiving surface 542 defines a distal boundary 564 of the cavity 544. The receiving portion 520 includes an internally threaded surface 566, 568 extending along at least a portion of the arms 526, 528 and the extensions 536, 540. The internally threaded surfaces 566, 568 are configured for engagement with a set screw (not shown).

[0119] The implant receiving surface 542 includes a saddle 570 that is configured to receive the spinal rod 14. The saddle 570 includes an end 572 and an end 574. The end 572 is configured to receive the spinal rod 14, and the end 574 is configured for engagement with the head 502 of the shaft 500 of the bone fastener 512.

[0120] The receiving portion 520 includes an inner surface defining a circumferential groove 576 configured for disposing a resilient member (eg, a ring 578), such as a Fig.30 As shown. Ring 578 is capable of contracting in upper groove 576. Ring 578 includes a circumference defining an opening (e.g., a gap). In some embodiments, the gap is sized so that the thickness of the gap is less than the height and width. In some embodiments, the gap is sized to allow ring 578 to translate through cavity 544 by contracting circumferentially. In some embodiments, when ring 578 and upper groove 576 are disposed together, the surface of upper groove 576 resists and / or prevents axial translation of ring 578 relative to axis DD.

[0121] The receiving portion 520 includes an inner surface defining a circumferential lower groove 580. The lower groove 580 is configured for disposing a resilient member, such as a ring 582. The ring 582 can expand in the lower groove 580 to connect the receiving portion 520 and the shaft 500. The ring 582 includes a circumference defining an opening (e.g., a gap). In some embodiments, the gap is sized so that the thickness of the gap is less than the height and width. In some embodiments, the gap is sized to allow the ring 582 to translate through the cavity 544 by circumferential contraction. In some embodiments, when the ring 582 is disposed with the lower groove 580, the surface of the lower groove 580 resists and / or prevents the ring 582 from axially translating relative to the axis DD. The inner surface defines an expansion groove 584.

[0122] The rings 578, 582 facilitate manual engagement / connection of the receiver 520 and the shaft 500. In some embodiments, the rings 578, 582 facilitate manual engagement / connection of the receiver 520 and the shaft 500, such that the shaft 500 is attached to the receiver 520 in a non-instrumented snap-fit ​​assembly, as described herein. In some embodiments, the receiver 520 is configured for pop-up engagement with the shaft 500.

[0123] In some embodiments, manual engagement and / or non-instrumented assembly includes a practitioner, surgeon, and / or medical staff member grasping the shaft 500 and the receiving portion 520 and forcibly snap-fitting the components together, as described herein. In some embodiments, manual engagement and / or non-instrumented assembly includes a practitioner, surgeon, and / or medical staff member grasping the shaft 500 and the receiving portion 520 and forcibly pop-fitting the components together and / or pop-fitting the receiving portion 520 onto the shaft 500, as described herein. In some embodiments, a force in the range of 2N to 50N is required to manually engage the shaft 500 and the receiving portion 520 and forcibly assemble the components. For example, a force in the range of 2N to 50N is required to snap-fit ​​and / or pop-fit ​​assemble the shaft 500 and the receiving portion 520. In some embodiments, a force in the range of 5N to 10N is required to manually engage the shaft 500 and the receiving portion 520 and forcibly assemble the components. For example, a force in the range of 5N to 10N is required to snap-fit ​​and / or pop-fit ​​assemble the shaft 500 and the receiving portion 520. In some embodiments, as described herein, the shaft 500 is manually engaged with the receiving portion 520 in a non-instrumented assembly such that a force and / or pull-out strength of at least 5000N is required to remove the receiving portion 520 and the shaft 500. In some embodiments, this configuration provides manually engageable components that can be assembled without instruments, and after assembly, the assembled components have a selected pull-out strength and / or can be pulled apart, removed, and / or separated with minimal force required.

[0124] In one embodiment, similar to the systems and methods described herein, the spinal implant system 10 is used in minimally invasive surgery to implement navigation techniques for posterior fixation of the cervical spine, such as Figures 31 to 56 As shown. For example, the spinal implant system 10 may include cervical pedicle screws that provide biomechanical fixation. In some embodiments, the spinal implant system 10 is used with a minimally invasive navigation cervical pedicle screw fixation technique that provides a biomechanical structure and can also be applied to percutaneous navigation C1 lateral mass-C2 part / pedicle screw / rod fixation and C1-2 transarticular screw fixation.

[0125] In some embodiments, spinal implant system 10 combines intraoperative navigation with minimally invasive muscle splitting techniques. In some embodiments, spinal implant system 10 includes minimally invasive muscle preservation techniques that achieve biomechanical lateral to medial trajectories utilizing larger diameter and longer screws while minimizing soft tissue exposure morbidity.

[0126] In some embodiments, the spinal implant system 10 includes a navigational percutaneous minimally invasive cervical pedicle screw fixation technique to achieve fixation. In some embodiments, this technique is a safer, less invasive method for fixation of the atlantoaxial spine (C1-2) and the lower cervical thoracic spine (C3-T2).

[0127] For example, the technique employs a spinal implant system 10 and includes placing a patient in a frame and positioning the patient in a prone position on an examination table with an attachment or cervical spine management system, such as Fig.31 As shown. If the fixation crosses the cervicothoracic junction, the alignment of the cervicothoracic junction is maintained in a neutral position. During positioning, the patient's head is maintained in a neutral position. In some embodiments, in C1-2 fixation, a slight flexion position provides better access to the C1 lateral mass and is appropriately repositioned once the screws are placed before the rod is placed. The shoulder is tied down to achieve access to the lateral neck.

[0128] like Fig.32 Because of the lateral-to-medial angle of percutaneous pedicle screw placement, extensive aseptic preparation of the neck is performed.

[0129] like Fig.32 As shown, intraoperative imaging is obtained by cone beam CT or 2-D fluoroscopy for use with an intraoperative navigation system. In some embodiments, in lower cervical spine fixation (C3-T2), a fiducial is placed caudal to the spinous process of the lowest instrumented vertebra. In some embodiments, in atlantoaxial fixation, an array fiducial attachment is placed directly on the retractor or C2 spinous process.

[0130] like Fig.33 As shown, once the fiducial array is placed and intraoperative CT is performed, the percutaneous incision can be planned. In some embodiments, a navigation stick with an extended projection is used to demonstrate the necessary entry points to provide the desired trajectory.

[0131] like Fig.34 As shown, once each entry point is determined, a linear incision is made along its path, sequentially cutting through the dermis to the overlying fascia. In some embodiments, the incision provides cosmetic closure rather than several small puncture incisions that may alternatively be used. In some embodiments, a small self-retaining retractor is utilized.

[0132] The percutaneous entry point is determined via a navigation wand through the fascia. Electrocautery is used downward through the fascia and the muscle fibers are directly divided in the craniocaudal plane. Any deep fascial layer can be released using electrocautery so that a navigation drill can be placed on the lateral mass (a 2 mm burr can alternatively be used). In some embodiments, electrocautery can be navigated to remove soft tissue from the pilot hole screw entry site. The drill is used to make a pilot hole, such as Fig.35The guide hole undergoes the drilling and tapping portion of the procedure, with or without direct visualization. The trajectory is confirmed using a navigation drill corresponding to the desired screw diameter and the drill is advanced into the lateral mass along the pedicle axis.

[0133] The drill is advanced to at least the middle of the pedicle. A 3.0 mm navigation tap is then used and advanced into the vertebra. Fig.36 As shown. In cases where the pedicle is small, the pedicle itself may not be fully cannulated using a drill and / or tap. Screw placement can follow the trajectory of the pedicle but may not penetrate the pedicle. Navigation drills and taps are small and tapered to allow access to the guide hole and advancement without direct visualization.

[0134] like Fig.37 As shown, use the navigation system to extend the tap and measure the appropriate size screw. Then place the navigation screwdriver with the screw and extension under the navigation (e.g., reset tower). Fig.38 As shown in Figure 2, after bilateral pedicle screw placement, the spinal rod is translated through the reduction towers. The rod is translated using a percutaneous technique and tested to confirm that it passes through all reduction towers. Fig.39 As shown, place the locking cap and tighten it finally. Remove the rod holder and perform final imaging, as shown Fig.40 As shown. Fig.41 As shown, the muscles, fascia, and skin are closed in layers. In some embodiments, the technology of the present disclosure does not employ a reduction tower, for example, for C1 lateral mass-C2 segment / pedicle fixation or C1-2 transarticular screw fixation. In some embodiments, the technology of the present disclosure can be used to place percutaneous lateral mass fixation by tilting the screw on a medial to lateral trajectory within the lateral mass plane.

[0135] Intraoperative and postoperative images show the C5-T1 structures. Fig.42 This is an axial CT scan of the C5 pedicle. Figure 43 to Figure 44 The final configuration is shown in Figure 2. Fig.43 ) and lateral ( Fig.44 ) Postoperative X-ray. Figure 45 to Figure 46 The C1-2 structure is shown in the positive position ( Fig.46 ) and lateral ( Fig.45 ) Postoperative X-ray. Fig.47 Axial intraoperative CT image showing bilateral entry of screws into the pedicles. Fig.48 Imaging of the postoperative anterior and posterior configurations at C4-5 is shown. Fig.49 Imaging of a C4 corpectomy with anterior plating is shown. Fig.50 Imaging of posterior instrumentation at C3-C5 is shown. Fig.51 Imaging of a narrow pedicle limiting the length of the placed screw is shown. Fig.52AP imaging of percutaneous pedicle screw fixation at C5-T1 is shown. Fig.53 Lateral imaging of percutaneous pedicle screw fixation at C5-T1 is shown. Fig.54 Intraoperative CTC spine imaging using C5 pedicle screws is shown. Fig.55 Postoperative CT imaging showing bilateral C5 pedicle screws is shown. Fig.56 Postoperative CT imaging showing bilateral C6 pedicle screws is shown.

[0136] In some embodiments, similar to the systems and methods described herein, the spinal implant system 10 is used to implement a navigation technique for posterior cervical fixation in a minimally invasive surgical manner. The technique includes placing the patient in a prone position; preparing the patient and applying a dressing extensively; performing intraoperative imaging for use with intraoperative navigation; placing a navigation reference array; planning incisions and screw placement; drilling screw entry points for drilling and tapping without direct visualization; performing pedicle / bone drilling and tapping under intraoperative navigation guidance; placing screws under intraoperative navigation guidance; passing a percutaneous rod through the reduction tower and applying a locking cap; and closing the wound.

[0137] In some embodiments, similar to the systems and methods described herein, the spinal implant system 10 is used for minimally invasive surgery to achieve navigation percutaneous pedicle screw fixation technology. In some embodiments, the technology avoids the disadvantages of open pedicle screw fixation, including blood loss, muscle morbidity and pain associated with posterior cervical approaches. In some embodiments, the technology facilitates accurate, navigated, minimally invasive, muscle-splitting screw placement through biomechanical fixation. In some embodiments, the technology eliminates the need for intraoperative fluoroscopy or dedicated tubular / cylindrical retractors. In some embodiments, the technology includes positioning the patient in a prone position and extensively preparing the patient to achieve a muscle-preserving approach from the outside to the inside. In some embodiments, intraoperative navigation is achieved by placing a navigation reference on a head frame or C2 spinous process for C1-2 fixation and on the spinous process of the upper thoracic vertebra for C3-T2 screw / rod fixation. In some embodiments, imaging is obtained using intraoperative flat plate or cone beam computed tomography CT, 2-D or 3-D fluoroscopy to be used with intraoperative spinal navigation. In some embodiments, navigation is utilized to plan and perform bilateral skin incisions above the bone anatomical structure, such as the pedicles to be fixed. In some embodiments, sharp dissection and blunt dissection are completed to expose the screw entry point usually on the lateral mass. In some embodiments, a small burr or drill is utilized to utilize a navigation high-speed drill to drill out the screw entry point without the need for direct visualization. In some embodiments, under navigation guidance, the trajectory of the screw from the outside to the inside is drilled and tapped. In some embodiments, a screw is placed under navigation guidance. In some embodiments, the rod is then attached to the screw through the extension piece percutaneously from C3-T2 or under direct visualization at C1-2. In some embodiments, a locking screw is applied and the wound is closed.

[0138] In some embodiments, similar to the systems and methods described herein, the spinal implant system 10 is used for minimally invasive surgery to achieve navigation percutaneous pedicle screw fixation technology. In some embodiments, the technology includes making the patient prone and fully prepared to allow a muscle-preserving approach from the outside to the inside. Intraoperative navigation is achieved by placing a navigation reference on the head frame or C2 spinous process for C1-2 fixation and placing a navigation reference on the upper thoracic spinous process for C3-T2 screw / rod fixation. Imaging is obtained using intraoperative flat plate or cone beam computed tomography CT, 2-D or 3-D fluoroscopy to be used with intraoperative spinal navigation. Navigation is used to plan and execute bilateral skin incisions above the bone anatomical structure, such as the pedicles to be fixed. Sharp dissection and blunt dissection are completed to expose the screw entry point usually on the lateral mass. In the case of using a small burr or drill bit, the screw entry point is drilled out using a navigation high-speed drill bit. The soft tissue and fascia around the lateral mass may cause difficulties in the cannulation of the initial guide hole and the tap trajectory. In some embodiments, to prevent this from happening, proper access is confirmed through the lateral neck musculature and fascia. If any resistance is encountered at the cannulation entry point or when purchasing the screw, a navigation rod is used to reposition and widen any muscle and fascia near the lateral mass entry point. The guide hole provides access for the drill and tap without direct visualization. The trajectory of the screw is drilled and tapped from the lateral to the medial side under navigation guidance. The screw is placed under navigation guidance. The rod is attached to the screw through the extension piece percutaneously from C3-T2 or under direct visualization at C1-2. In some embodiments, to reduce the risk of bilateral vertebral artery injury, screws are placed on only one side at a time. In some embodiments, if there is any concern about major breakage or inaccuracy in navigation, an intraoperative CT is performed before surgery on the contralateral side to confirm that there is no major foraminal rupture and potential vertebral artery injury. Locking screws are applied and the wound is closed.

[0139] In some embodiments, minimally invasive navigation posterior cervical screw fixation technology / minimally invasive navigation posterior cervical rod fixation technology utilizes intraoperative navigation (including robot-assisted intraoperative navigation) to improve the technology. This also includes augmented reality navigation to improve the technology.

[0140] In some embodiments, the technology can be utilized with or without the need for a tubular / cylindrical retractor. In some embodiments, the technology can be utilized with or without an extension screw. In some embodiments, the technology can be used for stand-alone posterior cervical fixation. In some embodiments, the technology can be utilized in conjunction with minimally invasive or open posterior cervical decompression. In some embodiments, the technology can be used in conjunction with anterior cervical decompression and stabilization as part of an anteroposterior or posterior-anterior single or staged surgical procedure.

[0141] In some embodiments, similar to the systems and methods described herein, the spinal implant system 10 is used for minimally invasive surgery to achieve navigation percutaneous pedicle screw fixation technology. In some embodiments, the technology includes positioning the patient in a head fixation, prone on an operating room examination table. The patient is prepared and extensively sterilized with a drape to facilitate bilateral approach, lateral to medial approach. The intraoperative navigation reference is placed on the head frame or in the C2 spinous process for posterior C1-2 screw / rod fixation, or placed on the lower cervical or upper thoracic spinous process for lower cervical C3-T2 fixation. Intraoperative cone beam CT or fluoroscopic images are obtained for use with intraoperative navigation. Using navigation, plan an outer skin incision parallel to the targeted cervical pedicle. Cut the soft tissue and muscle segmentation channel from the outside to the inside. Using navigation, drill a screw entry point parallel to the pedicle in the targeted lateral mass. Drill and tap the targeted pedicle, and place the screw under navigation guidance. After all the targeting screws are placed bilaterally, the percutaneous rod is passed through the extension piece bilaterally and the locking cap is engaged. The wound is closed. In some embodiments, the technology uses robotic intraoperative navigation / robotic assisted intraoperative navigation or augmented reality intraoperative navigation as described herein.

[0142] In some embodiments, similar to the systems and methods described herein, a spinal implant system 10 is used in a method for treating the spine, the method comprising the steps of: imaging a patient anatomy including a surgical site; selecting a minimally invasive path to a pedicle of at least one cervical vertebra including the patient anatomy; creating a cavity in at least a portion of the pedicle using at least one surgical instrument, the surgical instrument including a surgical navigation component that generates a signal representing the position of the surgical instrument relative to the surgical site; and engaging a bone screw (e.g., bone fastener 12 / bone fastener 212) with at least a portion of the pedicle using a surgical driver, the surgical driver including a surgical navigation component that generates a signal representing the position of the surgical driver and / or the bone screw relative to the surgical site.

[0143] In some embodiments, the step of selecting a path includes a generally lateral to medial trajectory of the patient's anatomy. In some embodiments, the step of selecting a path includes a lateral mass of a first cervical vertebra and a pedicle or pars interarticularis of a second cervical vertebra. In some embodiments, the step of selecting a path includes a medial trajectory along a lateral mass trajectory.

[0144] In some embodiments, the engaging step includes fixating the first cervical vertebra and the second cervical vertebra through the joint. In some embodiments, the engaging step includes fixating the first cervical vertebra and the first thoracic vertebra. In some embodiments, the method also includes the step of engaging a minimally invasive spinal rod (e.g., spinal rod 14) with a bone screw.

[0145] In some embodiments, at least one surgical instrument includes a surgical drill and a surgical tap, the surgical drill including a surgical navigation component and the surgical tap including a surgical navigation component. In some embodiments, a bone screw (e.g., bone fastener 12) includes: a receiving portion (e.g., receiving portion 20), the receiving portion including a first arm (e.g., arm 26) connected to a first extension (e.g., extension 36) and a second arm (e.g., arm 28) connected to a second extension (e.g., extension 40), the arms connected to the extension via breakaway surfaces (e.g., breakaway surfaces 46, 48), the arms including a proximal end surface (e.g., proximal end surfaces 34, 38); and the receiving portion also includes an implant receiving surface (e.g., implant receiving surface 42), the proximal end surface and the implant receiving surface defining an implant cavity (e.g., cavity 44), the breakaway surface being disposed within the implant cavity; and a threaded shaft (e.g., shaft 100), the threaded shaft being connectable to the receiving portion and being engageable with the at least one portion of the pedicle. In some embodiments, the receiving portion defines a longitudinal axis and the proximal end surface defines a transverse surface, the breakaway surface being axially spaced from the transverse surface.

[0146] In some embodiments, the step of creating the cavity includes: positioning a guide member with the patient anatomy, the guide member being configured for positioning at least one surgical instrument, and an image guide being oriented relative to a sensor to communicate a signal representing a position of the guide member, the guide member comprising an end effector of a robotic arm. In some embodiments, a tracking device is provided, the tracking device comprising a sensor that receives the signal and communicates with a processor to generate data for displaying an image from a monitor, the image representing a position of the guide member relative to the surgical site.

[0147] In some embodiments, a method for treating the spine is provided. In some embodiments, the method includes the following steps: imaging a patient anatomy including a surgical site; selecting a minimally invasive path of the patient anatomy, the minimally invasive path including a lateral mass of a first cervical vertebra and a pedicle of a second cervical vertebra; creating a cavity in at least a portion of the pedicle and at least a portion of the lateral mass using at least one surgical instrument, the surgical instrument including a surgical navigation component that generates a signal representing the position of the surgical instrument relative to the surgical site; engaging a bone screw (e.g., bone fastener 12 / bone fastener 212) with at least a portion of the pedicle and at least a portion of the lateral mass and engaging with a surgical driver, the surgical driver including a surgical navigation component that generates a signal representing the position of the surgical driver and / or the bone screw relative to the surgical site, the bone screw engaging at least a portion of the pedicle and at least a portion of the lateral mass for transarticular fixation of the first cervical vertebra and the second cervical vertebra; and engaging a minimally invasive spinal rod with the bone screw.

[0148] In some embodiments, at least one surgical instrument includes a surgical drill and a surgical tap, the surgical drill including a surgical navigation component and the surgical tap including a surgical navigation component.

[0149] In some embodiments, a bone screw (e.g., bone fastener 12) includes: a receiving portion (e.g., receiving portion 20), the receiving portion including a first arm (e.g., arm 26) connected to a first extension (e.g., extension 36) and a second arm (e.g., arm 28) connected to a second extension (e.g., extension 40), the arms connected to the extension via breakaway surfaces (e.g., breakaway surfaces 46, 48), the arms including a proximal-most end surface (e.g., proximal-most end surfaces 34, 38); and the receiving portion also includes an implant receiving surface (e.g., implant receiving surface 42), the proximal-most end surface and the implant receiving surface defining an implant cavity (e.g., cavity 44), the breakaway surface being disposed within the implant cavity; and a threaded shaft (e.g., shaft 100), the threaded shaft being connectable to the receiving portion and being engageable with the at least one portion of the pedicle and the at least one portion of the lateral mass. In some embodiments, the receiving portion defines a longitudinal axis and the proximal-most end surface defines a transverse surface, the breakaway surface being axially spaced from the transverse surface.

[0150] In some embodiments, the step of creating the cavity includes: positioning a guide member with the patient anatomy, the guide member being configured for positioning at least one surgical instrument, and an image guide being oriented relative to a sensor to communicate a signal representing a position of the guide member, the guide member comprising an end effector of a robotic arm. In some embodiments, a tracking device is provided, the tracking device comprising a sensor that receives the signal and communicates with a processor to generate data for displaying an image from a monitor, the image representing a position of the guide member relative to the surgical site.

[0151] In some embodiments, a method for treating a spine, the method comprising the steps of: imaging a patient anatomy including a surgical site; selecting a minimally invasive path to a pedicle of at least one cervical vertebra including the patient anatomy; creating a cavity in at least a portion of the pedicle using at least one surgical instrument, the surgical instrument including a surgical navigation component that generates a signal representing a position of the surgical instrument relative to the surgical site; and engaging a bone screw (e.g., bone fastener 12 / bone fastener 212) with at least a portion of the pedicle using a surgical driver, the surgical driver including a surgical navigation component that generates a signal representing a position of the surgical driver and / or the bone screw relative to the surgical site, the bone screw The nail includes a receiving portion (e.g., receiving portion 20), which includes a first arm (e.g., arm 26) connected to a first extension (e.g., extension 36) and a second arm (e.g., arm 28) connected to a second extension (e.g., extension 40), these arms are connected to the extension via detachment surfaces (e.g., detachment surfaces 46, 48), these arms include the most proximal end surface (e.g., the most proximal end surfaces 34, 38); and the receiving portion also includes an implant receiving surface (e.g., implant receiving surface 42), the most proximal end surface and the implant receiving surface define an implant cavity (e.g., cavity 44), the detachment surface is disposed in the implant cavity; and a threaded shaft (e.g., shaft 100), which is capable of being connected to the receiving portion and capable of engaging with at least one portion of the pedicle.

[0152] In some embodiments, the receiving portion defines a longitudinal axis and the proximal-most end surface defines a transverse surface, the breakaway surface being axially spaced from the transverse surface. In some embodiments, the step of selecting a path includes a lateral mass of a first cervical vertebra and a pedicle of a second cervical vertebra.

[0153] It should be understood that various modifications may be made to the embodiments disclosed in the present invention. Therefore, the above description should not be understood as limiting, but only as an illustration of various embodiments. Those skilled in the art will be able to envision other modifications within the scope and essence of the claims attached hereto.

Claims

1. A spinal implant, include: A receiving portion, the receiving portion comprising a first arm connected to the first extension portion and a second arm connected to the second extension portion, the arm being connected to the extension portion via a detachment surface, the arm comprising a proximal-most end surface, and the receiving portion further comprising an implant receiving surface, the proximal-most end surface and the implant receiving surface defining an implant cavity, the detachment surface being arranged in the implant cavity.

2. The spinal implant of claim 1, wherein the receiving portion defines a longitudinal axis and the proximal-most end surface defines a transverse face, the breakaway surface being axially spaced from the transverse face.

3. The spinal implant of claim 1, wherein the proximal-most end surface defines a proximal boundary of the implant cavity and the implant-receiving surface defines a distal boundary of the implant cavity.

4. The spinal implant of claim 1 wherein the arm defines a proximal shoulder including the proximal-most end surface, the breakaway surface comprising an undercut recessed into the shoulder.

5. The spinal implant of claim 1, wherein the breakaway surface comprises a first frangible wall connecting the first arm to the first extension and a second frangible wall connecting the second arm to the second extension.

6. The spinal implant of claim 5, wherein at least one of the walls has a circumferential configuration.

7. A spinal implant as described in claim 1, wherein the breakaway surface includes a first circumferential wall connecting the first arm to the first extension and a second circumferential wall connecting the second arm to the second extension, the walls having a reduced thickness relative to the extension.

8. The spinal implant of claim 1, wherein the implant receiving surface comprises a saddle configured to receive a spinal rod.

9. The spinal implant of claim 1, wherein the breakaway surface is configured to break and separate at a predetermined force or torque limit.

10. The spinal implant of claim 1, wherein the predetermined force or torque limit comprises a range of approximately 2 Nm to 8 Nm.

11. A bone fastener, include: a receiving portion, the receiving portion comprising a first arm connected to the first extension and a second arm connected to the second extension, the arms connected to the extensions via breakaway surfaces, the arms comprising proximal-most end surfaces, and the receiving portion further comprising an implant receiving surface, the proximal-most end surface and the implant receiving surface defining an implant cavity, the breakaway surface being disposed within the implant cavity; and A threaded shaft is connectable to the receiving portion and is engageable with vertebral tissue.

12. The spinal implant of claim 11, wherein the receiving portion defines a longitudinal axis and the proximal-most end surface defines a transverse face, the breakaway surface being axially spaced from the transverse face.

13. The spinal implant of claim 11, wherein the proximal-most end surface defines a proximal boundary of the implant cavity and the implant-receiving surface defines a distal boundary of the implant cavity.

14. The spinal implant of claim 11 wherein the arm defines a proximal shoulder including the proximal-most end surface, the breakaway surface comprising an undercut recessed into the shoulder.

15. The spinal implant of claim 11, wherein the breakaway surface comprises a first frangible wall connecting the first arm to the first extension and a second frangible wall connecting the second arm to the second extension.

16. The spinal implant of claim 11, wherein the breakaway surface comprises a first circumferential wall connecting the first arm to the first extension and a second circumferential wall connecting the second arm to the second extension, the walls having a reduced thickness relative to the extension.

17. A spinal implant, include: a receiving portion including a first arm connected to the first extension and a second arm connected to the second extension, the arms connected to the extensions via a breakaway surface, the receiving portion further comprising an inner surface having a selected threaded configuration extending along at least a portion of the arms and the extensions, The disengagement surface includes a helical formation and is aligned with the thread formation.

18. The spinal implant of claim 17, wherein the receiving portion further comprises an outer surface having a groove to define the breakaway surface.

19. The spinal implant of claim 17, wherein the breakaway surface comprises a first helical wall connecting the first arm to the first extension and a second helical wall connecting the second arm to the second extension, the walls having a reduced thickness relative to the arms and the extension.

20. The spinal implant of claim 17, wherein the receiving portion further comprises a saddle configured to receive a spinal rod.

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