Spinal implant systems and methods
Through the design of multi-axial bone fasteners and modular components, the stability and flexibility of the spinal rod in spinal surgery is solved, and the stable connection and flexible alignment of the spinal rod is achieved, improving the therapeutic effect.
Patent Information
- Application Number
- CN202380084209.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-12-07
- Filing Date
- 2023-12-05
- Publication Date
- 2025-07-25
AI Technical Summary
Existing spinal surgical treatment methods are difficult to effectively provide stability and flexibility, and it is difficult to align and fix the spinal rod during surgical procedures, resulting in poor treatment results.
Multi-axial bone fasteners, including the first and second crowns, are employed to secure the spinal implant in a selected orientation, combined with a modular ejection or snap fit assembly to achieve stable connection and flexible alignment of the spinal rod.
It provides stable connection and flexible alignment of the spinal rod, improves the therapeutic effect of surgical procedures, is suitable for a variety of surgical approaches and patient postures, and enhances the stability and flexibility of treating spinal diseases.
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Figure CN120379607A_ABST
Abstract
Description
Technical Field
[0001] This application includes subject matter related to U.S. Patent Application No. 18 / 076,766. The entire disclosure of the above application is incorporated herein by reference.
[0002] The present disclosure generally relates to medical devices for treating musculoskeletal disorders and, more particularly, to spinal implant systems and methods for treating the spine. Background Art
[0003] Spinal pathologies and disorders, such as kyphosis, scoliosis, and other curvature abnormalities, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, tumors, and fractures can be caused by factors including trauma, disease, and degenerative conditions resulting from injury and aging. Spinal disorders typically result in symptoms including deformity, pain, nerve damage, and partial or complete loss of mobility.
[0004] Non-surgical treatments (such as medications, rehabilitation, and exercise) may be effective but may not relieve symptoms associated with these disorders. Surgical treatments for these spinal disorders include correction, fusion, fixation, discectomy, laminectomy, and implantable prostheses. As part of these surgical treatments, spinal constructs including vertebral rods are commonly used to provide stability to the treatment area. During healing, the rod redirects stress away from the damaged or defective area to restore proper alignment and generally support the vertebral members. During the surgical treatment, one or more rods and bone fasteners may be delivered to the surgical site. The rod can be attached to the exterior of two or more vertebral members via the fasteners. The surgical treatment can employ surgical instruments and implants that are manipulated to engage the vertebrae to position and align one or more vertebrae. This disclosure describes improvements to these prior arts. Summary of the Invention
[0005] In one embodiment, a spinal implant is provided. The spinal implant includes a first member defining an implant cavity. A second member is movable relative to the first member and is tissue penetrable. A first crown is engageable with the first member. A second crown is engageable with the second member. The second crown is movable relative to the first crown to fix the first member relative to the second member in a selected orientation. In some embodiments, systems, spinal constructs, and methods are disclosed.
[0006] In one embodiment, a spinal implant includes a receiving portion defining an implant cavity and one or more grooves. A shaft is movable relative to the receiving portion. One or more bands are configured to be disposed within the one or more grooves and are engageable with a head of the shaft to connect the receiving portion and the shaft such that the receiving portion is movable relative to the shaft. A first crown is engageable with the receiving portion. A second crown is engageable with the shaft and is movable relative to the first crown between a non-locked orientation and a locked orientation, the non-locked orientation allowing multi-axial relative movement between the receiving portion and the shaft and the locked orientation fixing the receiving portion relative to the shaft in a selected orientation.
[0007] In one embodiment, a spinal implant includes a first member defining an implant cavity and one or more grooves. A second member is configured to penetrate tissue. One or more bands are configured to be disposed within the one or more grooves and are engageable with a head of the second member to connect the members such that the first member is movable relative to the second member. A crown is engageable with the members to fix the first member relative to the second member in a selected orientation. The crown includes a disengaging surface. BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The present disclosure will become more apparent from the following detailed description of the drawings, in which:
[0009] Figure 1 is a perspective view of components of an embodiment of a spinal implant system in accordance with the principles of the present disclosure;
[0010] Figure 2 is Figure 1 a perspective view of the components shown, with the parts separated;
[0011] Figure 3 is Figure 1 a perspective view of the components of the system shown;
[0012] Figure 4 is Figure 3 a partially sectional, separated view of the components shown;
[0013] Figure 5 is Figure 1 a perspective view of the components of the system shown;
[0014] Figure 6 is Figure 5 a perspective view of the components of the system shown;
[0015] Figure 7 is Figure 1 a partially sectional perspective view of the components of the system shown, with the parts separated;
[0016] Figure 8 is Figure 7 a partially sectional perspective view of the components of the system shown;
[0017] Figure 9 is Figure 7 A partial cross-sectional perspective view of a component of the system shown;
[0018] Figure 10 is Figure 1 A partial cross-sectional perspective view of the component shown;
[0019] Figure 11 is Figure 10 A side view of a component of the system shown;
[0020] Figure 12 is Figure 10 A perspective view of a component of the system shown;
[0021] Figure 13 is Figure 12 A side view of the component shown;
[0022] Figure 14 is Figure 1 A partial cross-sectional perspective view of a component of the system shown;
[0023] Figure 15 is Figure 14 A side view of a component of the system shown;
[0024] Figure 16 is Figure 1 A partial cross-sectional side view of a component of the system shown;
[0025] Figure 17 is Figure 16 A partial cross-sectional side view of a component of the system shown;
[0026] Figure 18 A perspective view of a component of an embodiment of a spinal implant system in accordance with the principles of the present disclosure, disposed with a vertebra;
[0027] Figure 19 A perspective view of a component of an embodiment of a spinal implant system in accordance with the principles of the present disclosure, disposed with a vertebra;
[0028] Figure 20 A perspective view of a component of an embodiment of a spinal implant system in accordance with the principles of the present disclosure, disposed with a vertebra;
[0029] Figure 21 A perspective view of a component of an embodiment of a spinal implant system in accordance with the principles of the present disclosure, disposed with a vertebra;
[0030] Figure 22 A perspective view of a component of an embodiment of a spinal implant system in accordance with the principles of the present disclosure;
[0031] Figure 23 is Figure 22 A perspective view of the components of the system shown, with the parts separated;
[0032] Figure 24 is Figure 22 A perspective view of the components of the system shown;
[0033] Figure 25 is Figure 22 A cross-sectional view of the components of the system shown;
[0034] Figure 26 is Figure 22 A side view of the components of the system shown in ;
[0035] Figure 27 is Figure 26 A cross-sectional view of the components of the system shown.
[0036] Figure 28 is Figure 26 A bottom view of the components of the system shown;
[0037] Figure 29 is Figure 26 A perspective view of the components of the system shown; and
[0038] Figure 30 is Figure 26 A perspective view of the components of the system shown. DETAILED DESCRIPTION
[0039] Exemplary embodiments of the disclosed surgical systems and related methods of use are discussed in the context of medical devices for treating musculoskeletal disorders, and more particularly, in the context of spinal implant systems and methods for treating the spine. In some embodiments, the surgical system includes spinal implants, such as multi-axial bone fasteners that are fixed to vertebral tissue, and includes an implant receptacle that is movable to receive a spinal implant (e.g., a spinal rod). In some embodiments, the implant receptacle is movable to a selected orientation for aligning and positioning the spinal rod. In some embodiments, the bone fastener includes a first crown and a second crown that are configured to fix the implant receptacle in the selected orientation. In some embodiments, the bone fastener includes a crown having a disengaging surface and capable of engaging the implant receptacle, and a shaft that is configured to fix the implant receptacle in the selected orientation. In some embodiments, the systems and methods of the present disclosure include surgical instruments and implants that are employed in conjunction with surgical treatments as described herein, such as in conjunction with the cervical, thoracic, lumbar, and / or sacral regions of the spine.
[0040] In some embodiments, the surgical system includes a spinal implant that includes a bone fastener, such as a multi-axial bone screw. In some embodiments, the multi-axial bone screw is capable of moving to a selected orientation relative to vertebral tissue and being fixed in the selected orientation. In some embodiments, the configuration converts the multi-axial screw into a fixed-angle screw. In some embodiments, the bone fastener includes an implant receiving portion, such as a head and a double-crown assembly. In some embodiments, the head includes an extender tab and a double-ring configuration for modular pop-off or snap-fit components. In some embodiments, the crown assembly includes an outer crown and an inner crown. In some embodiments, the head includes a pawl configured to engage the crown assembly. In some embodiments, the crown assembly is configured to be set with the head. In some embodiments, the head is positioned above the ball of the shank of the bone fastener. In some embodiments, the head is translated downward onto the shank. In some embodiments, the crown assembly is translated downward past the pawl in the head to lock the head to the shank.
[0041] In some embodiments, the surgical system includes a spinal implant that includes a bone fastener capable of moving between a pivoted position / unlocked orientation and a fixed axial screw position / locked orientation. In some embodiments, in the pivoted position / unlocked orientation, a socket disposed on the lower side of the inner crown facilitates selective pivoting of the head about the ball of the shank. In some embodiments, in the fixed axial screw position / locked orientation, the inner crown is threadedly engaged within the outer crown, and the socket of the inner crown engages the surface of the shank to prevent movement of the head about the ball of the shank. In some embodiments, the outer crown is driven against the head pawl to create a reaction force on the threaded inner crown. In some embodiments, in the fixed axial screw position / locked orientation, the spinal rod is fixed to the head. In some embodiments, after spinal correction is complete and the rod has been inserted into the head, the rod is fixed to the bone fastener via a fixation screw. In some embodiments, the fixation screw engages the head and the rod and is tightened.
[0042] In some embodiments, the surgical system includes a bone fastener configured to be set in a multi-axial locked orientation. In some embodiments, the configuration maintains operability and the ability of the head to pivot, such as during rod insertion. In some embodiments, the multi-axial orientation can be locked after the rod is inserted into the head and the fixation screw is tightened. In some embodiments, the fixation screw is driven downward on the rod, driving the socket of the inner crown onto the surface of the shank to prevent pivoting of the head. In some embodiments, maintaining the ability of the head to pivot during rod insertion provides variability in terms of ease of head positioning and / or rod setting.
[0043] In some embodiments, the surgical system includes a bone fastener, such as a multi-axial bone screw, that is configured to pivot and lock in a selected orientation to convert the multi-axial screw into a fixed-angle screw. In some embodiments, the head of the bone screw is configured to pivot to accommodate a spinal rod. In some embodiments, when the bone fastener is secured to a selected vertebra, the bone fastener can manipulate the vertebra using the head of the bone fastener as the head is locked in a fixed-angle orientation. In some embodiments, when the fixation screw is tightened, the head is locked to the rod. In some embodiments, the surgical system includes a single bone fastener that has multi-axial screw movement and fixed-axial screw movement in a single spinal implant.
[0044] In some embodiments, the surgical system includes a multi-axial screw having a dual-crown assembly that includes an inner crown and an outer crown. In some embodiments, the inner crown includes an outer surface located on the top of the inner crown that defines a raised ridge. In some embodiments, the raised ridge is configured to increase the amount of threads for engaging the outer crown and is configured for increasing the engagement of a surgical tool (e.g., a driver) with the inner crown. In some embodiments, the raised ridge increases the amount of threads for engaging the outer crown and the compression section so as not to interfere with tightening of the fixation screw to secure the rod to the head. In some embodiments, the inner crown includes a surface disposed on the lower side or socket of the inner crown that defines a deformable rib. In some embodiments, the deformable rib is configured to provide anti-slip when the inner socket of the crown engages the ball of the axis of the bone fastener.
[0045] In some embodiments, the surgical system includes a bone fastener configured for minimally invasive surgical techniques. In some embodiments, the bone fastener includes a fixed multi-axial screw. In some embodiments, the bone fastener includes a threaded crown that includes a breakaway drive section. In some embodiments, the bone fastener can be set in a selected orientation by selective angling of the head of the bone fastener. In some embodiments, the fixation screw portion of the crown is removed via a detachable portion to lock the head in a selected orientation. In some embodiments, the spinal rod is translated through the selectively aligned and fixed head. In some embodiments, the rod is secured to the head. In some embodiments, the crown is configured to fix or lock the orientation of the head in a selected orientation. In some embodiments, the bone fastener provides derotation of vertebral tissue without fully locking the rod.
[0046] In some embodiments, the bone fastener of the present invention includes a fixed multi-axial screw. In some embodiments, the bone fastener is modular, and the head is configured for a pop-off or snap-fit engagement with a selected axis of the bone fastener. In some embodiments, the bone fastener includes a threaded disconnect crown that is configured to align with the axis of the bone fastener to allow use in a percutaneous workflow. In some embodiments, the spinal rod is configured to be seated in a rod slot or implant receiving surface formed in the head such that the disconnected crown does not support the rod. In some embodiments, a selected amount of torque is applied to the bone fastener to secure the crown and remove the disconnect portion from the crown. In some embodiments, the user actuates the disconnect crown to fix the head in a selected orientation.
[0047] In some embodiments, the surgical system of the present invention includes a bone fastener that includes a modular fixed multi-axial screw. In some embodiments, the modular fixed multi-axial screw includes a head that can be moved to a selected orientation and locked in the selected orientation using a crown that includes a disconnect portion. In some embodiments, in the selected orientation, the crown is tightened in a downward direction using a disconnect driver, and the disconnect portion of the crown is removed. In some embodiments, the disconnect portion secures the screw in the selected orientation, e.g., a selected angle in a fixed angle screw configuration. In some embodiments, the modular fixed multi-axial screw provides alignment of one or more bone fastener heads before translating the rod through the head and maintains the head in the selected orientation. In some embodiments, the modular fixed multi-axial screw facilitates a derotation maneuver before the rod is fixed to the bone fastener. In some embodiments, the bone fastener includes a multi-axial fixed screw.
[0048] In some embodiments, the surgical system of the present disclosure can be used to treat spinal disorders such as, for example, 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 employed with other skeletal and bone-related applications, including those associated with diagnosis and therapy. In some embodiments, the disclosed surgical system can alternatively be used in surgical treatments where the patient is in the prone or supine position, and / or using various surgical approaches (including anterior, posterior, posterior midline, direct lateral, posterolateral, and / or anterolateral approaches) to access the spine, as well as other body regions. The surgical system of the present disclosure can also alternatively be employed with procedures for treating the lumbar, cervical, thoracic, sacral, 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, e.g., for training, testing, and demonstration.
[0049] A detailed description of embodiments with reference to the accompanying drawings, which form a part of this disclosure, will make the surgical system of this disclosure more easily understood. It should be understood that this application is not limited to the specific devices, methods, conditions, or parameters described and / or illustrated herein, and the terms used herein are merely for describing specific embodiments by way of example and not for limitation. In some embodiments, as used in the specification and including the appended claims, the singular forms "a / an" and "the" include the plural, and a reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as "about" or "approximately" a particular value and / or "about" or "approximately" another particular value. When expressing such a range, another embodiment includes from one particular value and / or to another particular value. Similarly, when a value is expressed as an approximation by use of the antecedent "about", it should be understood that the particular 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 for illustrative purposes only and may vary within the scope of this disclosure. For example, references to "upper" and "lower" are relative and are used in another context only, and are not necessarily "up" and "down".
[0050] As used in this specification and the appended claims, "treatment" of a disease or medical condition refers to a procedure that may include administering one or more drugs to a patient (a human, a normal human, or another person 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 bulge or a herniated disc and / or a bone spur) to relieve the signs or symptoms of the disease or medical condition. Relief may occur before the signs or symptoms of the disease or medical condition appear, or it may occur after they appear. Thus, treatment includes preventing a disease or an adverse medical condition (e.g., preventing a disease from occurring in a patient who may be predisposed to the disease but has not been diagnosed as having the disease). Additionally, 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 suppressing a disease, e.g., preventing its progression or alleviating a disease, e.g., 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, bone, and other tissues; as an adjunct to surgery; and / or any repair procedure. In some embodiments, unless otherwise clearly indicated, as used in the specification and including the appended claims, the term "tissue" includes soft tissue, ligaments, tendons, cartilage, and / or bone.
[0051] The following discussion includes a description of a surgical system, related components, and methods of using the surgical system that include spinal implants in accordance with 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. Turning to Figures 1 to 21 , components of a surgical system (e.g., spinal implant system 10) are illustrated.
[0052] The components of spinal implant system 10 may be made of biocompatible materials suitable for medical applications, including metals, synthetic polymers, ceramics, and bone materials and / or their composites. For example, the components of spinal implant system 10 may 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 ), ceramics and their composites (such as calcium phosphates (e.g., SKELITE TM ), thermoplastics (such as polyaryletherketones (PAEK), including polyetheretherketone (PEEK), polyetherketoneketone (PEKK), and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO4 polymeric rubbers, polyethylene terephthalate (PET)), fabrics, silicones, polyurethanes, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermosetting elastomers, elastomer composites, rigid polymers (including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy resins), bone materials (including autograft, allograft, xenograft, or transgenic cortical bone and / or cancellous bone, and tissue growth or differentiation factors), partially absorbable materials (e.g., composites of metals 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 polyketones, polyglycolide, polytyrosine carbonate, polycaprolactone), and combinations thereof.
[0053] The individual components of spinal implant system 10 may have material composites including the above materials to achieve various desired properties such as strength, stiffness, elasticity, compliance, biomechanical properties, durability, and radiopacity or imaging preference. The components of spinal implant system 10 may also be made, individually or collectively, of heterogeneous materials (such as combinations of two or more of the above materials). The components of spinal implant system 10 may be integrally formed, integrally connected, or include fastening elements and / or instruments as described herein.
[0054] The spinal implant system 10 is used, for example, with open surgical procedures, minimally invasive surgical procedures (including percutaneous techniques), and mini-open surgical techniques to deliver and introduce instruments and / or spinal implants (e.g., bone fasteners) at a surgical site of a patient, including, for example, the spine. In some embodiments, the spinal implant may include one or more components of one or more spinal constructs (e.g., intervertebral devices, interbody fusion cages, bone fasteners, spinal rods, tethers, connectors, plates, and / or bone grafts) and may be employed with various surgical procedures, including surgical treatment of the cervical, thoracic, lumbar, and / or sacral regions of the spine.
[0055] The spinal implant system 10 includes a spinal implant, such as a bone fastener 12, as Figure 1 and Figure 2 shown. The bone fastener 12 is configured to be fixed to a surgical site, which includes vertebral tissue, via a member (e.g., a shaft 106). The bone fastener 12 includes a member, such as a receptacle 20, configured to receive a spinal implant (e.g., a spinal rod 14). As described herein, the receptacle 20 is capable of moving to a selected orientation relative to the vertebral tissue and being fixed in the selected orientation. In some embodiments, the bone fastener 12 includes a multi-axial bone screw such that the receptacle 20 is capable of moving to a selected orientation relative to the vertebral tissue and being fixed in the selected orientation. In some embodiments, the receptacle 20 is capable of moving between a pivoted position / non-locked orientation and a fixed axial screw position / locked orientation with respect to the shaft 106 and / or the vertebral tissue. The bone fastener 12 extends between an end 16 and an end 18 and defines a longitudinal axis AA.
[0056] The receptacle 20 is capable of moving relative to the shaft 106. The receptacle 20 extends between a proximal end 22 and a distal end 24. The end 22 includes arms 26 and 28. In various embodiments, the arms 26, 28 each extend generally parallel to the axis AA. Each of the arms 26, 28 includes an arcuate outer surface extending between a pair of side surfaces. In some embodiments, at least one of the outer surfaces and side surfaces of the arms 26, 28 has at least one recess or cavity 30, 32 therein, which is configured to receive an insertion tool, a compression instrument, and / or an instrument for inserting and tensioning the bone fastener 12.
[0057] The arm 26 is configured to be connected to the extension 34 via the detachment surface 36, and the arm 28 is configured to be connected to the extension 38 via the detachment surface 40. The detachment surfaces 36, 40 are configured to break and separate under a predetermined force or torque limit. Each of the extensions 34, 38 includes an arcuate outer surface extending between a pair of side surfaces. In some embodiments, at least one of the outer surfaces and side surfaces of the extensions 34, 38 has at least one recess or cavity 42, 44 therein, which is configured to receive an insertion tool, a compression instrument, and / or an instrument for inserting and tensioning the bone fastener 12. In some embodiments, the extensions 34, 38 include extension tabs.
[0058] The receiving portion 20 defines an implant cavity 46. The implant cavity 46 is configured to receive the rod 14 and the fixation screw 48, as described herein. In some embodiments, the cavity 46 can have various cross-sectional configurations, such as oval, elliptical, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, deformable, and / or tapered.
[0059] The bone fastener 12 includes a crown 50 configured to engage with the receiving portion 20 and a crown 52 configured to engage with the shaft 106. The crown 52 is capable of moving relative to the crown 50 to fix the receiving portion 20 relative to the shaft 106 in a selected orientation, as described herein. In some embodiments, the crown 50 and / or 52 can be expandable, as Figures 7 to 9 shown, to fix the receiving portion 20 relative to the shaft 106 in a selected orientation. For example, the crown 52 is capable of moving relative to the crown 50 between a non-locked orientation / pivoting position (as Figure 10 and Figure 11 shown) and a locked orientation / fixed axial screw position (as Figure 12 and Figure 13 shown), the non-locked orientation / pivoting position allowing relative movement between the receiving portion 20 and the shaft 106, and the locked orientation / fixed axial screw position fixing the receiving portion 20 relative to the shaft 106 in a selected orientation, as described herein. In the non-locked orientation, the receiving portion 20 and the shaft 106 include multi-axial relative movement, and in the locked orientation, the relative movement between the receiving portion 20 and the shaft 106 is fixed.
[0060] The crown 50 is capable of axial translation relative to the crown 52 to fix the receiving portion 20 relative to the shaft 106 in a selected orientation. The crown 50 extends between a proximal end 54 and a distal end 56. The end 54 includes a proximal circumferential surface 58 capable of engaging with the inner surface 60 of the receiving portion 20, as Figure 4As shown. In some embodiments, the crown 50 includes a gap 62. The gap 62 is configured to facilitate deformation of the crown 50 to allow the crown 50 to be disposed with the cavity 46. The proximal surface 64 of the crown 50 is disposed with the proximal surface 66 of the crown 52 to define an implant receiving surface 68, as Figure 7 shown. The stem 14 can engage the implant receiving surface 68 to fix the receptacle 20 relative to the shaft 106 in a selected orientation. In some embodiments, the proximal surface 64 can have various surface configurations, such as, smooth, rough, arcuate, wavy, porous, semi-porous, pitted, polished, and / or textured configurations.
[0061] The proximal surface 64 of the crown 50 includes circumferential flanges 70, 72 that are configured to engage the pawls 74, 76 of the inner surface 60 of the receptacle 20, as Figure 11 and Figure 13 shown. In some embodiments, the flanges 70, 72 and / or the pawls 74, 76 can have various cross-sectional configurations, such as oval, elliptical, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, deformable, and / or tapered.
[0062] The crown 52 extends between a proximal end 78 and a distal end 80. The end 78 includes the proximal surface 66, and the end 80 includes a distal circumferential surface 82 that can engage a ball (e.g., the head 108 of the shaft 106). The crown 52 includes a through-hole 53. In some embodiments, a surgical tool (not shown) is configured to be disposed with the through-hole 53 such that the surgical tool can disengage the shaft 106 from the crown 52. The crown 52 includes an external threaded surface 84 that can engage the internal threaded surface 86 of the crown 50. In some embodiments, the threaded surfaces 84, 86 can include a single thread turn or multiple discrete threads. In some embodiments, the outer surface of the crown 52 can alternatively include a set of ratchet teeth (not shown) that can engage a snap ring (not shown). In some embodiments, the outer surface of the crown 52 or the inner surface of the crown 50 can alternatively include a set of ratchet teeth that can engage a positive pawl (not shown) of the inner surface of the crown 50 or the outer surface of the crown 52.
[0063] The surface 82 defines an inner socket 88 that includes at least one deformable ridge, such as a plurality of ribs 90, as Figure 5As shown. The ribs 90 are circumferentially disposed around the socket 88. The socket 88 and the ribs 90 are configured to engage the ridged surface 109 of the head 108 of the shaft 106 to prevent the receiving portion 20 from moving around the head 108. In some embodiments, the ribs 90 are configured to deform against the ridged surface 109 of the head 108, and the displaced material of the deformed ribs 90 is configured to provide additional anti-slip during engagement of the socket 88 with the head 108 compared to a crown having a single smooth socket feature. In some embodiments, the ridged surface 109 is large enough to provide additional material for movement resistance compared to a smooth socket, but small enough to be easily squeezed during tightening. In some embodiments, all or part of the socket 88 and / or the ribs 90 may have various surface configurations, such as rough, arcuate, wavy, porous, semi-porous, recessed, and / or textured, to enhance the fixation between the crown 52 and the head 108. In some embodiments, the ribs 90 are disposed around the socket 88 in a series, parallel, offset, and / or staggered configuration.
[0064] The proximal surface 66 of the crown 52 is capable of engaging the flanges 70, 72 of the crown 50. The proximal surface 66 includes deformable raised ridges 92 and deformable raised ridges 94, as Figure 5 and Figure 6 shown. In some embodiments, the ridge 92 is configured to increase the amount of thread for engaging the crown 50. In some embodiments, the ridge 92 increases the amount of thread for engaging the crown 50, and the ridge 92 squeezes to allow the rod 14 to fully contact the surface 66 of the crown 52. The ridge 94 is configured to increase the engagement of a surgical tool (e.g., a driver (not shown)) with the crown 52.
[0065] The bone fastener 12 includes an elastic member, such as a ring 96. The inner surface 60 of the receiving portion 20 defines a circumferential groove 98 configured for setting the ring 96, as Figure 11 shown. The ring 96 is capable of contracting in the upper groove 98. The ring 96 includes a circumference defining an opening (e.g., a gap). In some embodiments, the gap is sized such that the thickness of the gap is less than the height and width. In some embodiments, the gap is sized to allow the ring 96 to translate through the cavity 46 by circumferential contraction. In some embodiments, when the ring 96 is set with the upper groove 98, the surface of the upper groove 98 resists and / or prevents the ring 96 from axially translating relative to the longitudinal axis AA.
[0066] Bone fastener 12 includes an elastic member, such as loop 100. The inner surface 60 of the receiving portion 20 defines a circumferential lower groove 102. The lower groove 102 is configured to receive the loop 100. The loop 100 includes a circumference that defines an opening (e.g., a gap). In some embodiments, the gap is sized such that the thickness of the gap is less than the height and width. In some embodiments, the gap is sized to allow the loop 100 to translate through the cavity 46 by circumferential contraction. In some embodiments, when the loop 100 is disposed with the lower groove 102, the surface of the lower groove 102 resists and / or prevents axial translation of the loop 100 relative to the longitudinal axis AA. The inner surface 60 defines an expansion groove 104. The loop 100 is capable of expanding within the expansion groove 104 to connect the receiving portion 20 and the shaft 106.
[0067] Loops 96, 100 facilitate manual engagement / connection of the receiving portion 20 and the shaft 106. In some embodiments, loops 96, 100 facilitate manual engagement / connection of the receiving portion 20 and the shaft 106 such that the shaft 106 is attached to the receiving portion 20 in a non-instrumented snap-fit assembly manner as described herein.
[0068] In some embodiments, manual engagement and / or non-instrumented assembly includes a practitioner, surgeon, and / or healthcare provider grasping the shaft 106 and the receiving portion 20 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 healthcare provider grasping the shaft 106 and the receiving portion 20 and forcibly pop-fitting the components together and / or pop-fitting the receiving portion 20 onto the shaft 106 as described herein. In some embodiments, a force in the range of 2N to 50N is required to manually engage the shaft 106 and the receiving portion 20 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 106 and the receiving portion 20. In some embodiments, a force in the range of 5N to 10N is required to manually engage the shaft 106 and the receiving portion 20 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 106 and the receiving portion 20. In some embodiments, as described herein, the shaft 106 is manually engaged with the receiving portion 20 in a non-instrumented assembly manner such that removal of the receiving portion 20 and the shaft 106 requires at least 5000N of force and / or pull strength. In some embodiments, this configuration provides manually engagable components that can be assembled without instruments, and after assembly, the assembled components have a selected pull strength and / or can be pulled apart, removed, and / or separated with a minimum required force.
[0069] Shaft 106 includes a threaded portion 110 that is capable of engaging tissue (e.g., vertebral tissue). In some embodiments, threaded portion 110 may include a single thread coil or multiple discrete threads. Head 108 includes a tool engagement portion 112 that is configured to engage a surgical tool or instrument, as described herein. In some embodiments, portion 112 includes a hexagonal cross-section. In some embodiments, head 108 includes an outer surface having a planar surface or flats and / or an arcuate surface.
[0070] In the non-locking / pivoting orientation, as Figure 10 and Figure 11 shown, the socket 88 of the crown 52 facilitates pivoting of the receiving portion 20 relative to the head 108 of the shaft 106 in a selected direction, as Figure 11 shown by arrows A and B in Figure 12 . In the locking orientation / fixed axial screw position, the crown 52 is threaded into the crown 50 in a direction such as a clockwise direction (as Figure 12 shown by arrow C in Figure 13 ), and the socket 88 engages the surface 109 of the shaft 106 via ribs 90 of the crown 52 to prevent movement, e.g., to prevent pivoting of the receiving portion 20 relative to the head 108 of the shaft in the directions Figure 13 shown by arrows D and E in Figure 13 . The ribs 90 provide increased grip on the head 108 to prevent movement of the receiving portion 20. The crown 50 is translated via flanges 70, 72 to engage pawls 74, 76, thereby creating a reaction force on the crown 52, as Figure 13 shown by arrows F and G in Figures 14 to 15 . In the locking orientation, the rod 14 is fixed to the receiving portion 20. The rod 14 is fixed to the bone fastener 12 via a fixing screw 48, as Figures 14 to 15 shown. The fixing screw 48 engages the receiving portion 20 and the rod 14 and is tightened.
[0071] As Figures 14 to 15 shown, the ridges 92, 94 are thin enough to be squeezed by the rod 14 such that the rod 14 directly engages the surface 66 of the crown 52, thereby ensuring a stable connection between the rod 14 and the crown 52. The engagement between the crown 52 and the rod 14 for an extended period of time ensures that when the fixing screw 48 is tightened, the receiving portion 20 is forced to be perpendicular to the rod 14. In some embodiments, in the locking orientation / fixed axial screw position, when the fixing screw 48 is tightened, the bone fastener 12 is oriented perpendicular to the rod 14, and the patient's vertebra may move when the shaft 106 is anchored to the vertebra.
[0072] In some embodiments, the bone fastener 12 is configured for a multi-axial orientation. In some embodiments, this configuration maintains operability and the ability of the receiving portion 20 to pivot, for example, during insertion of the rod 14. In some embodiments, the multi-axial orientation can be locked after the rod 14 is inserted into the receiving portion 20 and the fixation screw 48 is tightened. In some embodiments, as Figure 17 shown by arrow H in, the fixation screw 48 translates towards the rod 14, driving the socket 88 of the crown 52 onto the surface 109 of the shaft 106 to prevent pivoting of the receiving portion 20. In some embodiments, this configuration maintains relative pivotable movement of the receiving portion 20 during insertion of the rod 14 such that the receiving portion 20 can be variably positioned and / or facilitate the placement of the rod 14.
[0073] In assembly, operation, and use, similar to the systems and methods described herein, the spinal implant system 10 includes a bone fastener 12 as described herein having a receiving portion 20 capable of connecting to a shaft 106 and is employed with a surgical procedure for treating a spinal condition affecting a section of a patient's spine as discussed herein. The spinal implant system 10 is employed with a surgical procedure for treating a condition or injury of an affected section of the spine.
[0074] In some embodiments, the spinal implant system 10 includes a spinal implant kit that includes one or more selected receiving portions 20 as described herein, the heads being configured for connection to one or more interchangeable shafts 106 to facilitate placement of the bone fastener 12 along a patient's vertebrae as described herein. In some embodiments, one or more selected interchangeable shafts 106 are connected to selected interchangeable receiving portions 20 to include one or more bone fasteners 12 and / or configurations. The components of the bone fastener 12 and one or more spinal implants (e.g., the rod 14) can be delivered or implanted as a pre-assembled device or can be assembled in situ. In some embodiments, the receiving portion 20 can be assembled with the shaft 106 on a back table in the operating room and inserted into a pre-assembled vertebra. The components of the spinal implant system 10 can be fully or partially modified, removed, or replaced.
[0075] To treat a selected section of a vertebra, including vertebra V, a medical practitioner accesses the surgical site including vertebra V in any suitable manner, such as by incision and retraction of tissue. In some embodiments, the spinal implant system 10 can be used with any existing surgical method or technique, including open surgery, mini-open surgery, minimally invasive surgery, and percutaneous surgical implantation, whereby vertebra V can be accessed through a mini-incision or a cannula providing protected access to the area. Once the surgical site is accessed, a specific surgical procedure can be performed to treat the spinal disorder.
[0076] An incision is formed in the patient's body, and a cutting instrument (not shown) forms a surgical path for implanting components of the spinal implant system 10. A preparation instrument (not shown) may be employed to prepare the vertebrae and the tissue surface for aspiration and irrigation of the surgical area.
[0077] One or more shafts 106 are fixed to the vertebra V, as Figures 18 to 21 shown, such that the shafts 106 are manipulated to drive the shafts 106 along a selected trajectory, twist the shafts, insert the shafts into the vertebra V, and / or align the shafts with the vertebra. The receiving portion 20 is provided in a snap-fit assembly with the shafts 106, as Figures 7 to 9 shown and described herein. The receiving portion 20 is assembled with each shaft 106 by translating the receiving portion in the direction of arrow A as Figure 8 shown. The engagement of the head 108 of the shaft 106 with the cavity 46 causes the surface of the head 108 to engage the ring 100, such that the ring 100 translates in the direction of arrow J as Figure 8 shown, thereby setting the ring 100 in an expanded orientation into the expansion groove 104. The head 108 further translates through the cavity 46 in the direction of arrow J and further through the ring 100 as the ring 100 is driven back into the lower groove 102. The ring 100 elastically contracts around the head 108 to its natural state.
[0078] The crowns 50, 52 are manipulated, for example, via the engagement of a surgical driver or inserter (not shown), to translate the crown 52 in a direction (e.g., the downward direction as shown by arrow K in Figure 9 ) such that the receiving portion 20 engages the head 108, and the crown 50 translates beneath the pawls 74, 76 via the flanges 70, 72. The end 80 of the crown 52 engages the ring 96 to set the ring 96 into the expansion groove 104 such that the ring 96 elastically opens to its natural orientation. The ring 96 is oriented for adjacent and / or contact engagement with the ring 100 to prevent and / or stop the ring 100 from translating from the lower groove 102 into the expansion groove 104 and thus provide a fixed connection of the components of the bone fastener 14, including permanent capture of the head 108 of the shaft 106.
[0079] In the non-locked orientation, the socket 88 of the crown 52 facilitates selective pivoting of the receiving portion 20 relative to the head 108 of the shaft 106, e.g., in the directions of arrows A and B as Figure 11 shown. In the locked orientation / fixed axial screw position, the crown 52 is threaded into the crown 50 in a clockwise direction (as shown by arrow C in Figure 12 ), and the socket 88 engages the surface 109 of the shaft 106 via the ribs 90 of the crown 52 to secure the components and prevent movement of the receiving portion 20 relative to the head 108, e.g., as Figure 13as shown by arrows D and E in. The ribs 90 provide gripping and / or frictional engagement on the head 108 to prevent movement of the receiving portion 20. The crown 50 is translated via the flanges 70, 72 to engage the pawls 74, 76, thereby generating a reaction force on the crown 52, as Figure 13 shown by arrows F and G in. In the locked orientation, the rod 14 is fixed to the receiving portion 20. The rod 14 is fixed to the bone fastener 12 via a fixation screw 48, as Figure 14 and Figure 15 shown. The fixation screw 48 engages the receiving portion 20 and the rod 14 and is tightened. In some embodiments, the bone fastener 12 is fixed to the selected vertebra V, as Figures 18 to 19 shown in, such that the bone fastener 12 can manipulate the vertebra V using the receiving portion 20, as Figures 20 to 21 shown in, because the receiving portion 20 is locked in a fixed angle orientation in combination with a surgical procedure (e.g., a corrective procedure). In some embodiments, when the fixation screw 48 is tightened, the bone fastener 12 and thus the vertebra V are oriented to the rod 14 to correct the spine.
[0080] In some embodiments, one or all of the components of the spinal implant system 10 can be delivered or implanted as a pre-assembled device or assembled in situ in a selected assembly order or an assembly order of specific components of the system 10 that can vary according to practitioner preference, patient anatomy, or surgical procedure parameters.
[0081] After completion of the procedure, the surgical instruments, components, and non-implantable parts of the spinal implant system 10 are removed from the surgical site and the incision is closed. One or more of the components of the spinal implant system 10 can be made of a radiopaque material such as a polymer. A radiological marker can be included for identification under x-ray, fluoroscopy, CT, or other imaging techniques. In some embodiments, the use of surgical navigation, microsurgery, and image-guided techniques can be used to access, view, and repair spinal degeneration or injury with the spinal implant system 10.
[0082] 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 alternative vertebral segments). In some embodiments, the bone fasteners can include multi-axial screws, sagittal adjustment screws, pedicle screws, uni-axial screws, uni-planar screws, facet screws, fixation screws, tissue penetration screws, conventional screws, expansion screws, wedges, anchors, buttons, clamps, fasteners, friction fittings, compression fittings, expansion rivets, staples, nails, adhesives, posts, fixed plates, and / or columns.
[0083] In one embodiment, the spinal implant system 10 includes a medicament that can be disposed, packaged, coated, or layered within, on, or around components and / or surfaces of the spinal implant system 10. In some embodiments, the medicament can include a bone growth promoting material (e.g., bone graft) to enhance fixation of the components and / or surfaces of the spinal implant system 10 to the vertebrae. In some embodiments, the medicament can include one or more therapeutic and / or pharmacological agents for release (including sustained release) to treat, for example, pain, inflammation, and degeneration.
[0084] In one embodiment, as Figures 22 to 30 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 to be secured to a surgical site, which includes vertebral tissue, via a member (e.g., shaft 306). The bone fastener 212 includes a member, such as a receiving portion 220 configured to receive a spinal implant (e.g., spinal rod 14). As described herein, the receiving portion 220 is capable of moving to a selected orientation relative to the vertebral tissue and being fixed in the selected orientation. In some embodiments, the bone fastener 212 includes a multi-axial bone screw such that the receiving portion 220 is capable of moving to a selected orientation relative to the vertebral tissue and being fixed in the selected orientation, as described herein. In some embodiments, the bone fastener 212 can be set in a selected orientation via selective angulation of the receiving portion 220, as described herein. In some embodiments, the bone fastener 212 includes a fixed multi-axial screw. In some embodiments, the bone fastener 212 is configured to derotate the vertebral tissue without fully securing the rod 14 to the receiving portion 220, as described herein. The bone fastener 212 extends between an end 216 and an end 218 and defines a longitudinal axis BB.
[0085] The receiving portion 220 is movable relative to the shaft 306. The receiving portion 220 extends between a proximal end 222 and a distal end 224. The end 222 includes arms 226 and 228 similar to arms 26, 28 described herein. In some embodiments, the arms 226, 228 each extend parallel to axis BB. The arm 226 is configured to connect to the extension 234 (similar to the extension 34 described herein) via the release surface 236, and the arm 228 is configured to connect to the extension 238 (similar to the extension 38 described herein) via the release surface 240. The release surfaces 236, 240 are configured to break and separate under a predetermined force or torque limit, similar to that described herein. The receiving portion 220 defines an implant cavity 246, similar to the implant cavity 46 described herein. The receiving portion 220 includes a rod slot, such as the implant receiving surface 247. The rod 14 is configured to be seated within the implant receiving surface 247 and is configured to engage a fixation screw (not shown) to secure the rod 14 with the bone fastener 212.
[0086] The bone fastener 212 includes a crown 250 that is configured to engage the receiving portion 220 and the shaft 306 to fix the receiving portion 220 relative to the shaft 306 in a selected orientation, as described herein. The crown 250 extends between a proximal portion (e.g., the fixation screw portion 254) and a distal portion 256. The crown 250 includes a through hole 255. In some embodiments, a surgical tool (not shown) is configured to be disposed with the through hole 255 such that the surgical tool can disengage the shaft 306 from the crown 250. The crown 250 includes an external threaded surface 258 that is configured to engage an internal threaded surface 260 disposed at the distal end 224 of the receiving portion 220, as Figure 25 shown. In some embodiments, the threaded portions 258, 260 may include a single thread turn or multiple discrete threads.
[0087] The crown 250 includes a release surface 262, as Figure 25 and Figure 27 shown. The release surface 262 is configured to connect the portions 254, 256, and the portion 254 can be removed from the portion 256 via the release surface 262 to fix and lock the receiving portion 220 in a selected orientation. The release surface 262 is disposed on a longitudinal axis CC that is transverse to the axis BB, as Figure 27As shown. The release surface 262 is configured to break and separate under a predetermined force or torque limit, as described herein. In some embodiments, the release surface 262 is made of a frangible and / or brittle material such that manipulating the release surface 262 can cause the portion 254 to break and separate from the portion 256 under a predetermined force and / or torque limit, as described herein. The release surface 262 has a reduced thickness relative to the portions 254, 256 to facilitate breakage and separation. In the depicted embodiment, the portion 254 is illustrated as extending a short distance above the release surface 262, but may extend further, such as beyond the arms 226, 228.
[0088] In some embodiments, the release surface 262 includes a predetermined force or torque, and the predetermined force or torque limit includes a range of about 2 Nm to 12 Nm. In some embodiments, the portions 254, 256 may have the same or alternative cross-sectional configurations, may be made of homogeneous materials or heterogeneously of different materials, and / or alternatively may be formed of materials having a greater degree, characteristic, or property of plastic deformability, frangible characteristics, and / or breakability to facilitate breakage and separation of the portions 254, 256. In some embodiments, the crown 250 may not include a release surface, and a torque limiting instrument (not shown) is implemented to apply a selected amount of tightening torque to the crown 250.
[0089] The portion 254 defines a tool engagement portion 266 that is configured to engage a surgical tool or instrument, as Figure 30 shown. In some embodiments, the portion 266 includes a hexagonal cross-section. The portion 256 defines an inner socket 268 as Figures 27 to 29 shown, which is configured to engage the head 308 of the shaft 306, as Figure 25 shown. In some embodiments, all or part of the socket 268 may have various surface configurations, such as rough, arcuate, wavy, porous, semi-porous, recessed, and / or textured, to enhance the engagement between the crown 250 and the head 308. In some embodiments, the socket 268 may include ridges similar to the ridges 90 described herein.
[0090] The bone fastener 212 includes rings 270, 276 that facilitate manual engagement / connection of the receiving portion 220 and the shaft 306, similar to that described herein. In some embodiments, the rings 270, 276 facilitate manual engagement / connection of the receiving portion 220 and the shaft 306 such that the shaft 306 is attached to the receiving portion 220 in a non-instrumented snap-fit assembly manner, as described herein.
[0091] The shaft 306 includes a threaded portion 310 that is capable of engaging tissue, such as vertebral tissue. In some embodiments, the threaded portion 310 may include a single thread coil or multiple discrete threads. The head 308 includes a tool engagement portion 312 that is configured to engage a surgical tool or instrument, as described herein. In some embodiments, the portion 312 includes a hexagonal cross-section. In some embodiments, the head 308 includes an outer surface having a planar surface or flats and / or a curved surface.
[0092] In assembly, operation, and use, the spinal implant system 10 includes a bone fastener 212 as described herein that has a receiving portion 220 capable of connecting to the shaft 306, and the spinal implant system is employed with a surgical procedure for treating a spinal condition affecting a spinal segment of a patient as discussed herein. In use, for example, the receiving portion 220 and the shaft 306 are disposed in a snap-fit assembly, similar to that described herein. The receiving portion 220 is capable of rotating in a selected orientation, such as in the Figure 25 directions indicated by arrows L and M therein. The crown 250 is threadedly engaged with the threaded surface 260 of the receiving portion 220 via a threaded surface 258 and is translated in the Figure 25 direction indicated by arrow N therein via a disconnect driver (not shown). A portion 254 of the crown 250 is removed via a disengaging surface 262 at a selected predetermined force or torque limit to secure the bone fastener 212 in a selected fixed-angle screw configuration. In some embodiments, the rod 14 is secured to the receiving portion 220 via a set screw (not shown).
[0093] In some embodiments, the bone fastener 212 includes a modular fixed multi-axial screw that provides alignment of one or more receiving portions 220 and maintains the receiving portion 220 in a selected orientation prior to translating the rod 14 through the receiving portion 220. In some embodiments, the bone fastener 212 includes a modular fixed multi-axial screw that facilitates a derotational maneuver prior to securing the rod 14 to the bone fastener 212.
[0094] It should be understood that various modifications may be made to the embodiments disclosed herein. Accordingly, the above description should not be construed as limiting, but merely as illustrative of various embodiments. Those skilled in the art can envision other modifications within the scope and spirit of the appended claims herein.
Claims
1. A spinal implant, the spinal implant comprising: A first member that defines an implant cavity; A second member that is movable relative to the first member and is tissue penetrable; A first crown that is engageable with the first member; And A second crown that is engageable with the second member, The second crown being movable relative to the first crown to fix the first member relative to the second member in a selected orientation.
2. The spinal implant according to claim 1, wherein the second crown is movable relative to the first crown between an unlocked orientation and a locked orientation, the unlocked orientation enabling relative movement of the members and the locked orientation fixing the first member relative to the second member in the selected orientation.
3. The spinal implant according to claim 1, wherein in the unlocked orientation, the members include multi-axial relative movement.
4. The spinal implant according to claim 1, wherein the crowns are expandable to fix the first member relative to the second member in the selected orientation.
5. The spinal implant according to claim 1, wherein the first crown includes a proximal circumferential surface that is engageable with the inner surface of the first member, and the second crown includes a distal circumferential surface that is engageable with the head of the second member.
6. The spinal implant according to claim 1, wherein the proximal surfaces of the first crown and the second crown are disposed together to define an implant receiving surface.
7. The spinal implant according to claim 6, the spinal implant further comprising a spinal rod that is engageable with the implant receiving surface to fix the first member relative to the second member in a selected orientation.
8. The spinal implant according to claim 1, wherein the first crown is axially translatable relative to the second crown to fix the first member relative to the second member in the selected orientation.
9. The spinal implant according to claim 1, wherein the second crown includes an external threaded surface that is engageable with the internal threaded surface of the first crown.
10. The spinal implant according to claim 1, wherein the second crown includes a distal surface that is engageable with the head of the second member, the distal surface including a deformable ridge.
11. The spinal implant according to claim 1, wherein the second crown includes a proximal surface that is engageable with the circumferential flange of the first crown, the proximal surface including a deformable ridge.
12. The spinal implant according to claim 1, wherein the first member defines an implant cavity and one or more grooves; and the spinal implant further comprises One or more bands configured to be disposed within the one or more grooves and engageable with the head of the second member to connect the members such that the first member is movable relative to the second member.
13. The spinal implant according to claim 1, wherein the first member includes a receiving portion having a first arm connected to a first extension and a second arm connected to a second extension, and the arms are connected to the extensions via a release surface.
14. A spinal implant comprising: A receiving portion defining an implant cavity and one or more grooves; A shaft movable relative to the receiving portion; One or more bands configured to be disposed within the one or more grooves and engageable with a head of the shaft to connect the receiving portion and the shaft such that the receiving portion is movable relative to the shaft; A first crown engageable with the receiving portion; And A second crown engageable with the shaft and movable relative to the first crown between a non-locked orientation and a locked orientation, the non-locked orientation allowing multi-axial relative movement between the receiving portion and the shaft, and the locked orientation fixing the receiving portion relative to the shaft in a selected orientation.
15. The spinal implant according to claim 14, wherein a proximal surface of the first crown and a proximal surface of the second crown are provided together to define an implant receiving surface, and the spinal implant further includes a spinal rod engageable with the implant receiving surface to fix the shaft relative to the receiving portion in a selected orientation.
16. A spinal implant comprising: A first member defining an implant cavity and one or more grooves; A second member configured to penetrate tissue; One or more bands configured to be disposed within the one or more grooves and engageable with a head of the second member to connect the members such that the first member is movable relative to the second member; And A crown engageable with the members to fix the first member relative to the second member in a selected orientation, The crown including a release surface.
17. The spinal implant according to claim 16, wherein the crown includes a proximal portion and a distal portion connected by the release surface, and the release surface has a reduced thickness relative to the portions.
18. The spinal implant according to claim 17, the spinal implant further including a spinal rod engageable with the implant cavity to fix the first member relative to the second member in the selected orientation.
19. The spinal implant according to claim 16, wherein the crown includes an external thread surface engageable with an internal thread surface of the first member.
20. The spinal implant according to claim 16, wherein the member includes a multi-axial bone screw.