Separable bony anchor apparatus, instruments, and methods for surgical applications

Abstract

Separable bone anchor(s), useful for treating bone segments such as in conjunction with rod system(s) to encourage bone fusion, stabilize, maintain spacing between, or couple the bone segments, having reduction towers with one or more separable segments and corresponding joints. The separable segments may be spread and angled outward or completely removed at one or more of the joints. Special multifunctional tools for driving the anchors and manipulating rods and housing are also provided. Such systems facilitate precise correction, reduction, and fixation while accommodating a wide range of clinical indications (e.g., fractures, deformities, degenerative conditions).

Description

ATTORNEY DOCKET: JB001P-PCTTITLE:SEPARABLE BONY ANCHOR APPARATUS, INSTRUMENTS, AND METHODS FOR SURGICAL APPLICATIONSREFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of U.S. Provisional Applications 63 / 749,737 and 63 / 752,657 which are hereby incorporated herein by reference.FIELD

[0002] The present disclosure relates generally to the field of orthopedic surgery and, more particularly, to integrated systems including a separable bony anchor apparatus, instruments, and methods that facilitate the correction, stabilization, and fusion of bony segments in mammals. By enabling precise placement and secure fixation of implant components, this apparatus can address abroad range of musculoskeletal conditions, including bone fractures and joint disorders.BACKGROUND OF THE INVENTION

[0003] Various musculoskeletal conditions such as fractures, joint disorders, deformities, and degenerative diseases can lead to bony instability, pain, and functional impairment in affected bones and joints. A bone fracture, for example, is a medical condition in which there is a partial or total break in the continuity of a bone. In humans, fractures are extremely common; according to the Mayo Clinic, over three million fractures occur in the United States each year. Fractures typically manifest as pain, deformity, swelling, bruising, numbness, and difficulty with movement.Diagnosis is often made via x-ray imaging or other bone scans, followed by treatment that may involve resetting (reducing) the bone and immobilizing it with casts, splints, or surgical fixation devices such as screws, rods, or plates. Surgical treatment, when indicated, may include either internal or external fixation, both of which aim to support proper bone alignment and promote healing.

[0004] Joints, where two or more bones articulate, can also be sites of injury and disease. Common joint issues include arthritis, lupus, sprains, strains, and dislocations, all of which can cause pain and dysfunction. Specific conditions such as sacroiliac joint disruption or degenerative sacroiliitis may require immobilization to alleviate symptoms, sometimes necessitating internal fixation devices. Similarly, the spine, which is composed of a series of articulating bony segments (vertebrae), can be affected by degenerative disc disease, congenital malformations, injuries, and other pathologies that compromise stability and alignment, often resulting in chronic pain or neurological deficits.

[0005] In many cases, especially those involving the spine or weight-bearing joints, correction and stabilization of bony segments are necessary to restore function and alleviate pain. Fusion procedures, coupled with implantable hardware, are frequently employed to address these conditions. Existing implantable devices and fixation systems may be limited in their ability to provide flexible yet robust stabilization, achieve precise anatomical correction, or simplify the surgical process for multi- segmental or complex pathologies. In addition, traditional designs can be challenging to adapt to varying patient anatomies and may not offer separable or modular components that can be selectively attached or detached based on intraoperative findings or postoperative progress.

[0006] Traditional surgical techniques often require multiple specialized instruments and separate implant components for each operative step: site preparation, anchoring, rod or plate or connector placement, reduction maneuvers, and final locking. In more complex cases, such as multi-level spinal fusion or large deformity corrections, frequent instrument exchange and step-by-step procedures can prolong operative time and increase complexity.

[0007] Over time, various systems have sought to improve flexibility and adaptability in fixation devices. However, there remains a need for improved systems and methods to correct, stabilize, and facilitate fusion of bony segments in vertebrates.SUMMARY OF THE INVENTION

[0008] The present invention is directed to systems and methods which provide streamlined and efficient methods and apparatus for orthopedic surgery, especially involving bony anchoring and fixation, that provide increased and flexible access and visibility of a minimally invasive surgical site. The present disclosure describes a separable bony anchor apparatus, multifunctional tools, and related methods for treating various musculoskeletal conditions, including fractures, deformities, and other disorders affecting bony segments in mammals. A separable bony anchor apparatus could address the aforementioned concerns by providing a design that allows secure fixation, customizable alignment, and ease of adaptation to the patient’s specific anatomical or pathological requirements. The present disclosure offers a solution intended to meet these needs, potentially reducing surgical complexity while improving patient outcomes in fracture management, spinal realignment, and joint stabilization or fusion. Multifunctional Surgical Instruments for use with the Bony Anchor aim to simplify complex orthopedic and spinal procedures while maintaining secure and adjustable fixation. By consolidating features that may now represent multiple individual tools into fewer, multifunctional tools and integrated procedural steps, surgeons can accomplish site preparation, fixation, reduction, and final locking with fewer instrument exchanges and reduced operative time. In various embodiments, the disclosed system facilitates the surgical correction, stabilization, and fusion of bony segments via a polyaxial screw assembly design. The system may include one or more polyaxial screw assemblies, connecting rods or plates, and an optional suite of surgical instruments (e.g., drivers, guides, or reduction tools).

[0009] Embodiments of the invention include a separable bony anchor apparatus that includes a bony anchor with a semi -spherical head (i.e., a screw), a U-shaped housing (which may be referred to as a “tulip”) with a hole at the base of the U through which the screw passes. The housing has a semi -spherical surface that mates with the head of the screw providing a range of rotation and angles there between. A compression locking cap can be threaded into the housing to lock a rod in a desired position therein. A key feature of the separable bony anchor apparatus is that each housingincludes a tower or extensions that includes one or more separable sections. These sections can be independently detached or partially separated to increase surgical access, enhance leverage, or allow for incremental adjustment of vertebral or other bony segments. In some embodiments the detachable extensions can be re-secured or left separated, depending on clinical requirements.

[0010] In some embodiments, the system may incorporate radiographic markers or navigation features, improving intraoperative visualization and accuracy. Other embodiments combine multi-segment correction capabilities with modular instruments for streamlined surgical workflows.

[0011] In one aspect, the disclosed separable bony anchor system allows surgeons to selectively lock or unlock different portions of the anchor head. This design enables polyaxial articulation, accommodating variable angles of insertion and alignment. Once inserted, the anchor can be locked at a desired orientation to achieve stable fixation across multiple bony segments.

[0012] In another aspect, surgeons can attach or remove a connecting rod or plate by partially separating a portion(s) of the tower, thus avoiding overly large incisions or complicated maneuvers. This feature may reduce operative time and decrease overall surgical complexity.

[0013] Additional potential benefits include: enhanced reduction capability for complex fractures or deformities, as surgeons can apply controlled forces through the separated anchor head sections; reduced tissue disruption, thanks to a more targeted approach when introducing or adjusting implants; and improved versatility, because each anchor can be adapted to different anatomical locations, bone densities, and angles of insertion.

[0014] In certain embodiments, the separable bony anchor apparatus may be used with traditional spinal fixation rods, crosslinks, connectors, or other orthopedic implants for reconstructive or corrective surgeries. It can also be adapted for non-spinal applications where multi-angled fixation or segmented leverage is beneficial, such as in cranial, extremity, long bone, or pelvic fixation procedures.

[0015] The disclosed apparatus may be especially advantageous in scenarios requiring staged corrections, where incremental realignment of a deformity is desired over multiple sessions. After the initial fixation, the surgeon can re-access the separable sections to adjust or upgrade the fixation setup, optionally incorporating new components or biologies as needed.

[0016] Thus, the separable bony anchor system and associated methods provide a versatile, separable, and surgeon-friendly solution for correcting, stabilizing, and fusing bony segments in mammals. The system may be deployed in a range of orthopedic or neurosurgical procedures to address fractures, scoliosis, degenerative disc disease, spondylolisthesis, or other conditions that require stable multi-segment fixation.

[0017] While certain embodiments described herein focus on spinal surgeries, the underlying principles also apply to other orthopedic contexts where controlled fixation, multi-segment articulation, and / or incremental correction are desired.

[0018] The foregoing has outlined rather broadly the features and technical advantages of the present invention in order that the detailed description of the invention that follows may be better understood. Additional features and advantages of the invention will be described hereinafter which form the subject of the claims of the invention. It should be appreciated by those skilled in the art that the conception and specific embodiment disclosed may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes of the present invention. It should also be realized by those skilled in the art that such equivalent constructions do not depart from the scope of the invention as set forth in the appended claims. The novel features which are believed to be characteristic of the invention, both as to its organization and method of operation, together with further objects and advantages will be better understood from the following description when considered in connection with the accompanying figures. It is to be expressly understood, however, that each of the figures is provided for the purpose of illustration and description only and is not intended as a definition of the limits of the present invention.BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The accompanying drawings, which are incorporated in and form part of the specification in which like numerals designate like parts, illustrate embodiments of the present invention and together with the description, serve to explain the principles of the invention. In the drawings:

[0020] FIG. 1 A is a simplified isometric drawing of a bony anchor according to an embodiment of the invention.

[0021] FIG. IB is a simplified front view of a bony anchor according to an embodiment of the invention.

[0022] FIG. 1C is a simplified right-side view of a bony anchor according to an embodiment of the invention.

[0023] FIGS. 2A-2D are simplified views (isometric, rear, top, and left side) of an adjacent bony-segment fixation system, including two rods, a plurality of separable bony anchors, and compression locking caps according to an embodiment of the invention.

[0024] FIG. 3 is a simplified isometric drawing of a separable bony anchor according to an embodiment of the invention.

[0025] FIGS. 4A-4B are simplified front and side views, respectively, of a separable bony anchor assembled with a compression locking cap according to an embodiment of the invention.

[0026] FIG. 5 is a simplified side view of a separable bony anchor assembly with a compression locking cap and rod in a final locked configuration according to an embodiment of the invention.

[0027] FIGS. 6A-6C are simplified front, side, and isometric views of a compression locking cap housing according to an embodiment of the invention.

[0028] FIGS. 7A-7B are simplified front and side views, respectively, of joined separable members according to an embodiment of the invention.

[0029] FIG. 8 is an exploded view of the separable bony anchor assembly of FIG. 3, illustrating the separable members.

[0030] FIGS. 9A-9D provide top isometric, bottom isometric, bottom, and left-side views of a compression locking cap according to an embodiment of the invention.

[0031] FIG. 10 is a simplified front isometric drawing of an example separable bony anchor according to an embodiment of the invention.

[0032] FIG. 11 is a simplified front isometric drawing of an example separable bony anchor according to an embodiment of the invention.

[0033] FIG. 12 is a simplified front isometric drawing of an example separable bony anchor according to an embodiment of the invention.

[0034] FIG. 13 is a simplified front isometric drawing of an example separable bony anchor according to an embodiment of the invention.

[0035] FIG. 15 is a side perspective view showing the separable bony anchor of FIG. 1 with the separable head partially disengaged for additional surgical access.

[0036] FIG. 16 is a simplified isometric drawing showing the separable bony anchor of FIG. 3 with the separable head partially disengaged for additional surgical access.

[0037] FIG. 18 is a simplified isometric drawing of a multifunctional driver and reduction tool according to an embodiment of the invention

[0038] FIG. 19 is a side view of the tool of FIG. 18..

[0039] FIG. 20A is a simplified isometric drawing of a rod rocker, rod pusher, housing turner tool according to an embodiment of the invention.

[0040] FIG. 20B is a close-up view of a portion of a rod rocker, rod pusher, housing turner tool according to another embodiment of the invention.

[0041] FIG. 21 is a simplified isometric drawing of the rod rocker, rod pusher, housing turner tool of FIG. 20A in use with a bony anchor.

[0042] FIG. 22A through 22F show a multi-functional Tower Separator, Spreader, and Centering Tool according to an embodiment of the invention.

[0043] FIG. 23A-C shows an external separable tower segment in use with a bony anchor according to an embodiment of the invention.

[0044] FIG. 24 shows a Manual Tower Manipulator Tool according to an embodiment of the invention.

[0045] FIG. 25 shows the Manual Tower Manipulator Tool in use with a separable bony anchor.

[0046] FIG. 26 shows a Manual Tower Manipulator Tool according to another embodiment of the invention.

[0047] FIG. 27 shows a multifunctional Tower Manipulation Tool according to another embodiment of the invention.

[0048] Fig. 28A - D show a process using a tool embodiment with a separable bony anchor embodiment.DETAILED DESCRIPTION

[0049] The following description illustrates embodiments of the separable bony anchor apparatus and method for bony segment correction, stabilization, and fusion in mammals. It should be understood that various modifications and alternative forms may be devised without departing from the scope of the present disclosure. The components, features, and methods described herein may be combined, rearranged, or omitted in different ways. Accordingly, the following detailed description should not be interpreted in a limiting sense, and the scope of the invention is defined by the appended claims.

[0050] It may be desirable to treat one or more bony segments (90) via separable bony anchors (60) in conjunction with other stabilization components or system(s), such as rods (40) to encourage bony fusion, provide stabilization, maintain spacing, or couple the bony segments (90), as shown in FIGS. 2A-2D. Separable bony anchor 60 includes bony anchor 10, compression locking cap housing 20, and compression locking cap 50. It should be noted that in these figures, the separable segments to be discussed later have been removed.

[0051] Referring to FIGS. 1 A-1C, an illustrative bony anchor (10) includes a tool interface (12), a semi-spherical head (14), a body (16), and a tapered, extended, tip section (18). In some embodiments, the bony anchor (10) may have a generally linear shape with subsections of varying diameters and threads (16A-16C) along the body (16) and a tip diameter (18A) at the tip section (18). The tip section has a taper 18B from the tip diameter 18A to the body diameter at subsection 16C. By way of example, the diameter of subsection (16C) can be substantially larger than tip diameter (18A), potentially on the order of 17.5 to 52.5 times larger in some embodiments.

[0052] The tool interface section (12) may include a drive interface (12A) shaped to mate with a driver tool for torque transmission (e.g., during anchor insertion), a tapered ramp (12B) for ease of access, and an impaction interface (12C). In some embodiments, the head section (14) is substantially spherical and may have a textured surface (14A) to allow articulation once the bony anchor (10) is seated in compression locking cap housing (20). This spherical head (14) configuration enables a restricted but useful range of motion when used in conjunction with a compression locking cap housing (20), a rod (40), and a compression locking cap (50), as shown in FIGS. 2A-2D and FIG. 5.

[0053] The body section (16) and tip section (18) may include a series of helical threads having helical bearing surfaces (ledges or ramps) ( thread 17) arranged about the body. Each thread (17) may have a flat or angled ledge 17A and an undercut ledge 17B. The flat or angled ledge 17A may be the leading bearing surface which can facilitate insertion of the bony anchor (10) into a bony segment (90), while the undercut edges 17B may be the trailing bearing surface which can help prevent expulsion of the bony anchor (10) once it is embedded in the bone. The tip section (18) may similarly have helical threads with a flat or angled surface and an undercut surface, starting at the tip 18A and gradually increasing in diameter with the taper of the tip section, thus leading into the threads of the body section. The smaller diameter of body and threads at the tip (18A) eases insertion. The taper 18B of the tip section may form an angle of approximately 10 to 70 degrees relative to the longitudinal axis of the anchor (e.g., about 20 degrees in one embodiment). In someembodiments, the tip section (18) may also have relief sections (18C), which can include cutting flutes on the sides; for example, two flutes may be formed in the tip section (18). This design can reduce the force required to insert the bony anchor (10) into the targeted bone.

[0054] In operation, a separable bony anchor (“SB A”) (60) may be inserted into a desired position in a bony segment (90) using an impaction tool that contacts the flat impact surface (12C). The tool interface (12) may include an internal drive section (12A) sized to receive a driver or removal tool. FIG. 1A shows a star-shaped drive socket, but any desired drive system could be used, such as hex, square, Phillips, slotted, conical, and the like. The body (16) may have cylindrical sections including smooth top section 16A, multiple-start, threaded section 16B, and single- or multiplestart, threaded, bottom section 16C. As shown in FIGS. 2A-2D, an implant rod (40) may include a plurality of SBA interfaces that are spherical, enabling the SBA (60) to pivot and translate over a large range within the compression locking cap housing (20) before being compressed by the compression locking cap (50).

[0055] Referring to FIGS. 9A-9D, an illustrative compression locking cap (50) includes a tool interface (52), a body (54), and a tip section (56). As shown in FIG.9D, the compression locking cap (50) may have a generally cylindrical shape with varying diameters (54A-54C) along the body (54) and a tapered diameter at the tip section (56). When coupled to a rod (40), the compression locking cap (50) may form approximately a 90-degree interface at its tip section (56) relative to the rod (40). Annular rings or ridges (56A, 56B, 56C) on the tip 56 can deform to provide holding force on the rod (40) after compression.

[0056] When inserted between bony segments (90), as shown in FIGS. 2A-2D, an SBA (60) can provide substantial retention and anti-expulsion force. In some embodiments, the bony segments (90) are vertebrae with a disc nucleus located between adjacent vertebrae. The system (100), including a rod implant (40) and multiple SB As 60, (made up of anchor 10, compression locking cap housing 20 and compression locking cap 50), can be configured for insertion from a posterior approach (e.g., as part of a lumbar fusion construct). The bony segments 90 areshown as vertebrae, but it should be understood that embodiments of the invention may be used to treat other bones as well.

[0057] As shown in FIGS. 6A-6C, the compression locking cap housing (20) may include: grip surfaces (22) for translational manipulation, e.g. with an external or an integral reduction tower or reducer designed for that purpose; a reduction thread that engages with the compression locking cap (50); a retention interference surface (26) that contains and provides friction on the bony anchor and / or on a saddle (27 in FIG.14) inserted just above the anchor head for a rod to seat onto; and a bearing surface (28) for the anchor head (14) to seat against, permitting polyaxial motion.

[0058] Referring to FIGS. 3, 7A-7B, 8, and 10-15, embodiments with integral reduction towers are shown. The integral towers are integrally, but separably, j oined to the locking cap housing (also known as a rod receiver or a “tulip”). The joined separable members (30) may be composed of any number of separable pieces (32, 32', 32", 32"') that incorporate one or more joining and decoupling interfaces (36, 36', 36", 36"'). The separable member attached directly to locking cap housing 20 is distal segment 32. (Note that distal is from a surgeon’s point of view.) More and more proximal segments 32', 32", 32"' may be partially or fully removed individually or all at once along with segment 32 as needed. Such pieces (32) can be threaded (as shown at 34), fully separated during use, or partially separated to provide the desired range of motion or access. Any of these separable members (32) can be part of the overall separable bony anchor assembly as illustrated by assemblies 60-64. FIG. 14 shows the SB A 62 or 63 of FIG. 11 or 12, respectively, with distal segments 32", 32"' separated leaving only the proximal segment 32 and next segment 32'. FIG. 15 and FIG. 16 illustrate spreading distal segment 32' for ease of access. As noted, any segment or combination of segments may be spread, pivoted or angled directionally as desired, removed, or otherwise positioned as needed during surgery. Stiffening element 38 is shown near the top or proximal end of the tower to stabilize the two extensions. Such stiffeners may be used at any position, at a joint, or between joints, and on one side or both, individually or in multiple locations.

[0059] Tf removal of an inserted SBA (60) is necessary, it may be extracted along the linear axis of the body (16) shown in FIG. 1C. A removal tool may couple to the SBA (60) via the internal drive feature (12A), allowing the surgeon to rotate and apply linear friction to withdraw the implant from the bone.

[0060] An external or separate separable reduction tower segment may also be used according to an embodiment of the invention. The external reduction tower segment includes means to temporarily attach to or grip the housing or other tower segments. The external reduction tower may be one of the segments or may be multiple segments of the multi separable tower just like the integral separable tower segments. The external reduction tower may be detached from and reattached to or resecured to the housing. This may be an advantage for some surgeries over the integral tower which can only be detached from the housing, not reattached.

[0061] According to embodiments of the invention, specifically chosen parameters have been found to improve the overall performance of the SBA.

[0062] Dual-Threaded Embodiment: A screw or bony anchor may incorporate a dualstart thread, for example in sections 18 and 16C, with a lead ranging from about 7 mm to 9 mm, or a pitch ranging from about 3.5 mm to about 4.5 mm. The anchoring screw’s twin-helical threads enable faster insertion while maintaining strong purchase in cancellous and cortical bone. The 7-9 mm lead range also strikes a balance between rapid thread engagement and controlled insertion torque. Pitch is the spacing of adjacent threads, while Lead is the thread spacing of a single start thread or lead. For a dual thread, Lead = 2 x Pitch.

[0063] Multi-Lead Threads: Some embodiments may have a Triple-start or three-Lead screw section (such as section 18 and 16C) and may have a lead of 9-11 mm. A triple-helix thread design (i.e., three separate thread leads running in parallel) with a combined lead of approximately 9-11 mm is an alternative to the previously described dual-thread embodiments. This multi-lead configuration can further reduce the number of rotations required to seat the anchor, thereby expediting insertion while still providing excellent purchase.

[0064] A Quad-Lead- or Hex -Lead-Threaded Section 16B may be included and may be 5-20 mm in Length. This higher number of thread leads (4 or 6 starts) can further enhance fixation in denser cortical bone regions, improving pullout strength and anchor stability in challenging anatomies. Note that in the transition from 2 to 4 leads, or from 3 to 6 leads, the pitch is reduced by half, and the lead is maintained constant.

[0065] Polyaxial Articulating Ball Head: The implant’s ball head is 0.5 mm to 1 mm larger than typical market standards (which are around 7.5 mm or less). The ball head may thus be from 7.5 to 9 mm in diameter, or from 8.0 to 8.5 mm. The head is also positioned more distally than standard designs (i.e., section 16A may be shortened or shorter), thus increasing the range of articulation without necessitating an increase in the overall tulip height or raising the rod’s position relative to the bone. This geometry expands alignment corrections within a smaller vertical profde. The system offers an enhanced angle of screw-rod articulation without additional vertical height. This approach supports a wide range of alignment corrections within a compact construct.

[0066] Enhanced Geometric Interference Under the Ball Head: An interference dimension 0.5 mm to 2 mm greater than the standard fosters a more robust head -tulip engagement, reducing the risk of slippage or deformation under high loads and increasing overall reliability. A precisely augmented interference area under the ball head fortifies the implant’s ability to withstand high corrective forces, improving long-term stability for procedures involving significant deformity correction or multilevel fixation.

[0067] Deformity Derotation Features: Integrated markers or notches on the screw shank enable the surgeon to identify deformity correction parameters intraoperatively. This design flexibility also supports potential revisions, permitting easier realignment and re-engagement if needed. Notches on the polyaxial tulip provide real-time, intraoperative feedback and point of interface leverage for rotational orientation or offset positioning. Surgeons can more readily assess how much correction is appliedor still needed. This feature can also facilitate future revisions or hardware adjustments.

[0068] Cannulated or Non-C annul ated Shank: The anchor may be cannulated to accommodate guide wires for precise placement, especially in minimally invasive procedures. Alternatively, the shank can be solid (non-cannulated) for a more rigid construct if guide-wire-based placement is not required.

[0069] Fenestrated or Non-Fenestrated Shank: Fenestrated designs include one or more openings along the anchor’s length, permitting the injection of bone graft material or biologies directly into the surrounding bone. This approach can enhance fusion or bone growth. Non-fenestrated designs have a continuous, solid shank for maximum structural integrity and simpler manufacturing.

[0070] Ribbed and Textured Semi-Spherical Anchor Head: The semi-spherical head (or ball head) may incorporate ribs or textures that generate friction within the tulip housing. This friction helps maintain the tulip’s orientation during anchor insertion and before the final locking step, reducing unintended slippage and simplifying alignment. These micro or macro textures allow for a “friction fit” that is adjustable yet sufficiently stable under moderate loads, thus improving ease of placement in multi-level constructs.

[0071] Tapered Tip for Easier Insertion: The distal end of the anchor is tapered to facilitate penetration through cortical bone or dense cancellous bone with reduced insertion torque. A smoothly contoured taper may also limit the risk of microfracture in delicate bone segments.

[0072] Neck Diameter Less Than or Equal to the Minor Diameter of the Shank: By designing the neck diameter 16A to be less than or equal to the anchor’s minor thread diameter (at 16B), the implant can achieve a consistent range of polyaxial articulation regardless of overall shank diameter. This maintains high variability of angulation within a lower implant profile and ensures that surgeons do not lose articulation freedom when choosing larger or smaller screw diameters.

[0073] Threaded Locking Cap with Optimized Diameter (9-14 mm): A compression or locking cap having a diameter between 9 mm and 14 mm accommodates greater torque transmission and secure locking against the rod or plate. This design also facilitates easier handling and offers a broad range of controlled compression.Surgeons benefit from increased working area for instrument engagement, minimizing risk of cap stripping or incomplete locking.

[0074] Integrated Reduction Feature: A single integrated reduction mechanism on the implant or instrument interface allows multiple reduction tools (e.g., rod pusher, reduction screw extenders, or persuaders) to engage the same feature. This approach diminishes the need for separate alignment guides or extenders, reducing clutter and surgical steps.

[0075] The inventive geometry of the SBA (60) can provide greater expulsion strength and more reliable cortical vertebral endplate penetration when inserted into a vertebra (90). In some embodiments, the outer surface of the SBA (60) may have scaling or texturing to enhance osteointegration. The ramps (16B) and undercuts can further grip bone, while the tip (18) can reliably penetrate cortical vertebral endplates without causing or incurring fracture damage when it is inserted. In various embodiments, the SBA (60), rod implant (40), and compression locking cap (50) may be formed of a biocompatible, substantially radiolucent material or combination of materials (e.g., polyether ether ketone (PEEK), titanium, cobalt chrome, or another suitable alloy).

[0076] In one embodiment, the rod implant (40) may be formed of a polymer, ceramic, metal, or alloy, including PEEK or other polyaryletherketone family members, titanium, or cobalt chrome. The SBA (60) may likewise be formed of a metal, alloy, or other osteoconductive material. For example, the SBA (60) may be titanium.

[0077] FIG. 17 illustrates a method of using the inventive SB As. In operation, surgeons typically drill and tap a pilot hole in the targeted vertebra or bone segment, aim the polyaxial screw assembly at the hole (112), insert the SBA into the bone using a driver (114), and then position the connecting rod (116). Adjustment of the housings and / or the rods may be needed (117). The rod is typically seated into the housing adjacent the reduction tower extensions. At some stage, the SBA tower withits separable segments may be spread as needed for ease of access and / or one or more segments removed (118). Once the rods are properly aligned and seated, the surgeon tightens the locking mechanism (122) to apply compression to the assembly to fully seat and secure the rod (124). The driver is then removed from the field of operation (126), followed by complete removal of any remaining separable members (128). It should be noted that the order of these steps may be varied as needed, Some steps may be repeated or even omitted as needed.

[0078] Overall, the separable bony anchor apparatus offers a versatile, modular, and efficient approach to bony segment correction, stabilization, and fusion. By enabling partial or complete separation of the anchor head, the system streamlines rod insertion, enhances corrective leverage, and accommodates a wide range of anatomical variations.

[0079] Multifunctional Surgical Instruments. Most common in the art are single function orthopedic instruments or tools. Occasionally there may have been tools that could be said to perform two distinct functions during surgery. Inventive tools for orthopedic surgery with three or more distinct functions are disclosed herein.

[0080] FIG. 18 and FIG. 19 illustrate an Integrated Insertion and Reduction Tool (210).In one embodiment, a single driver instrument has one end 214 that mates with the internal drive feature or tool interface of the dual-threaded screw. The same instrument can be equipped with a connection interface (212) to attach a gripping or handling tool to provide ease of use, additional instrument length, or additional lever arm. such as an inline handle, T-handle, drill, or driver, , avoiding the need for separate, dedicated instruments for each step. A tool shaft (216) may pass through a reduction sleeve or tower, allowing surgeons to apply insertion torque and alignment forces with fewer tool exchanges. It may include friction surface(s) for manual use. It may also include a so-called “stab and grab” feature which enables it to engage and hold a screw on a driver end. The feature may be a taper that creates a wedging affect that when the driver tip is inserted into the screw head tool interface. One or both ends of the tool could have the “stab and grab” feature. The two ends could have different driver types, styles, or sizes. For example, in the case of a revision surgery,one end may have a removal drive (male or female), and the other end could have an appropriate driver for the new SBA system.

[0081] FIG. 20A-B and FIG. 21 show two embodiments of a Combined Rod Lever, Rod Pusher, and Housing Positioning Mechanism (220 and 220'). A levering interface (which includes two-pronged fork 225, protrusions or pins 222. and contact surface 228) may provide rod persuasion , reduction, centering, and / or positioning when the pins are positioned against the grip surfaces (22) of the compression locking cap housing (20). Semi-circular cupped or curved interface(s) (224) on this multifunctional instrument can provide rod persuasion and / or rod centering and / or rod alignment (i.e., pushing the rod into the rod receiver or housing, centering about the apex of the cup or curve, and aligning the rod using two or more points of contact). A positioning interface (flat 226) is wider than the flat-to-flat (22' to 22' in FIG. 6A) distance of the compression locking cap housing (20) for positioning the compression locking cap housing (20). The positioning interface 226 also has a smaller width dimension at the cylindrical shaft than the inner diameter of the rod channel of the compression locking cap housing (20). The combined instrument 220 thus unifies tasks typically performed by multiple instruments. FIG. 20B shows a close up of the working end of another embodiment of the rocker tool 220’. The pins 222’ are similar, the forks 225 and cups 224’ are a little differently shaped. Other shapes may be used as well. This tool may also have a handle or handle interface 212. FIG, 21 shows the rocker tool 220 in position to manipulate a bony anchor housing 20.

[0082] FIG 22A-F shows a Tower Separator, Tower Spreader, and Centering Tool 230.One or more separator and spreader protrusions (234, 236) may provide separation between separable members (30) when positioned and rotated at a joint. Two or more like protrusions are preferred on opposing sides of the end of the tool. The same tool 230 may provide spreading of separable members (237, 237') when positioned away from a joint as shown in FIG. 22F. The tool may likewise be used to spread the extensions of an external tower to separate it from the housing or from another segment it may be attached to. A cannulation (232) in the shaft of this multifunctional instrument can provide centering of other tools (e g. drivers,adjustors, tighteners, wires, and the like). Separation and spreading of the separable members (30) may provide surgical access or viewing of the operational field.Centering of tools reduces time and error during a surgical procedure. FIG’s 22A - D show step-wise how tower separator tool 230 may separate tower segments by inserting the tool into the segment so that the protrusions are at, on, or about the appropriate joint, rotating the tool until separation, and removing the tool and segment.

[0083] The Tower Separator Tool (230) may also provide Final Separation. Final separation of the tower from the compression locking cap housing (20) allows the implantation of the implant. The final separation method includes separation of the separable tower (30) from the compression locking cap housing (20) by the following steps. The tower separator, tower spreader, and centering tool 230 may be inserted into the separable tower (30) by orienting the tool and its separator and spreader protrusion(s) 234 around the separable tower stiffening element(s) (38) and / or severing the stiffening elements as necessary. Stiffening element(s) (38) may be severed using tools such as the tower manipulator tool 250, wire cutters, pin cutters, or cutting forceps or shears. The protrusion(s) 234 are positioned at, above, or adjacent to the joint of the separable tower 30 and the compression locking cap housing 20, the tool is rotated to contact the sides of the separable tower (30) to the point of joint separation. Joint separation may occur at more than one side of the tower due to rotating the tool or at a single side of the tower, in which case the tool is angled away from the separated side, causing the joint to separate completely. After final separation, the tower separator, tower spreader, and centering tool 230 then may remove the tower from the operating field. It is typical to connect a T-handle to the tower separator, tower spreader, and centering tool 230 for additional torque during spreading and final separation. It is typical that final separation occurs after the reduction rod and compression housing are fully seated and tightened.

[0084] FIG. 23A-C shows a bony anchor screw 10 and housing 20 with an external separable tower segment 240 in three relative positions. FIG. 23A shows external tower 240 fully engaged with housing 20 in a most distal position. FIG. 23B showsexternal tower 240 separated from the housing. FIG. 23 C shows external tower 240 reattached to an integral tower segment.

[0085] FIG. 24 and FIG. 25 shows a Manual Tower Manipulator Tool (250). One or more manipulator interfaces may provide manipulation and / or positioning of separable members (30). Manipulation and positioning the separable members (30) may provide surgical access or viewing of the operational field. The tool has a working end 252 with a semi-annular opening 254 that fits over at least one tower extension section. FIG. 25 illustrates the use of two manipulator tools 250 to spread the two tower extensions of tower 30 by angling them outward at joint 36'. This may be useful to provide better access to the anchor 10, tower 30 and / or housing 20. (254). In another embodiment s), as shown in FIG. 26, Manual tower manipulator tool 250' may provide severing of a stiffening element 38 by placing a severing edge 256 over the stiffening element and rotating the tool until severing occurs. Severing a stiffening element 38 may provide easier manipulation, spreading, or separation of the separable members 30. Manual tower manipulator tool 250' may include a visual aid 258 to provide ease of visualization of the surgical site. A visual aid 258 may include a visualization element such as mirror, a lens, a magnifying glass, a lighting element, and / or a camera. The manual tower manipulator tool 250 may also provide centering of other tools by use of the cannulation for inserting other tools through the tool shaft.

[0086] FIG. 27 shows a Tower Manipulation Tool 260. Tower Manipulation Tool 260 may provide tissue retraction, compression, distraction, and retraction by an externally connected tower element(s) 262 fitting over top of a separable member(s) 30 and positioning mechanism 264 to translate the externally connected tower element(s) 262. The Tower Manipulation Tool 260 may include a visual aid 266 to provide ease of visualization of the surgical site. A visual aid may include a visualization element such as mirror, a lens, a magnifying glass, a lighting element, and / or a camera.

[0087] FIG. 28A-D illustrates a bony anchor 10, housing 20, a separable tower 30 with an external separable tower member 240, and the tower separator tool 230 in fourrelative positions. FIG. 28A shows external tower member 240 connected and the separator tool 230 above the SBA 60. FIG. 28B shows the separator tool 230 inserted into the external member 240. FIG. 28C shows the separator tool 230 rotated to spread the connection elements 242, thereby separating the external member 240. FIG. 28D shows the removal of the external member 240 and the tool 230.

[0088] On each tool, a handle interface (such as 212) may be provided to be usable with any known style of handle. The handle interfaces (212) shown are square drives, but any other suitable interface may be used, for example, A0, Jacob’s chuck, quickconnect, or other such connections. The handle may also be integral with the tool.

[0089] Use and Advantages. Reduced Operative Time: Integration of insertion, reduction, and compression steps into fewer instruments streamlines workflow and cuts down on intraoperative tool changes. Simplified Inventory: Hospitals and surgical centers can reduce the number of specialized tools and implant sets they must stock, helping lower costs and simplifying sterilization. Enhanced Clinical Outcomes: multiple thread leads, enlarged ball head articulation, and additional interference geometry yield strong and reliable fixation, even under challenging biomechanical conditions. Adaptability to Various Pathologies: Whether for spinal fusion, long bone fracture repair, or other skeletal stabilization, the system’s universal geometry and integrated instrumentation significantly reduce the learning curve.

[0090] This Detailed Description should therefore not be taken in a limiting sense. The scope of some embodiments is defined only by the appended claims, along with the full range of equivalents to which such claims are entitled. References herein to “invention” or “inventive subject matter” are provided merely for convenience and do not limit the scope to any single concept or embodiment if more than one is disclosed. Thus, although specific embodiments have been illustrated and described, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to encompass any and all adaptations or variations of some embodiments, including combinations of disclosed features that are not explicitly described together.

[0091] The Abstract of the Disclosure is provided to comply with 37 C.F.R. §1.72(b), requiring an abstract that allows a reader to quickly ascertain the nature of the technical disclosure. It is understood that it will not be used to interpret or limit the scope or meaning of the claims. In the foregoing Detailed Description, various features are grouped together in a single embodiment for the purpose of streamlining the disclosure. This method of disclosure is not intended to require more features than are expressly recited in each claim. Rather, inventive subject matter may reside in fewer than all features of a single disclosed embodiment.

[0092] The appended claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment. All such modifications and variations are within the scope of the present invention as determined by the appended claims, when interpreted in accordance with the full benefit to which they are fairly, legally, and equitably entitled.

[0093] While the preferred embodiment has been described with reference to the figures, numerous modifications, additions, and subcombinations are possible without departing from the scope of the invention, as defined by the appended claims. The accompanying drawings, which form a part hereof, illustrate by way of example, and not of limitation, specific embodiments in which the subject matter may be practiced. The embodiments illustrated provide enough detail to enable those skilled in the art to practice the teachings disclosed. Other embodiments may be utilized and derived therefrom, allowing structural and logical substitutions and changes without departing from the scope of this disclosure.

[0094] Although the present invention and its advantages have been described in detail, it should be understood that various changes, substitutions, and alterations can be made herein without departing from the scope of the invention as defined by the appended claims. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means, methods, and steps described in the specification. As one of ordinary skill in the art will readily appreciate from the disclosure of the present invention, processes, machines, manufacture, compositions of matter, means,methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present invention. Accordingly, the appended claims are intended to include within their scope such processes, machines, manufacture, compositions of matter, means, methods, or steps. The invention disclosed herein may suitably be practiced in the absence of any element that is not specifically disclosed herein.

Claims

CLAIMSWhat is claimed is:

1. A separable bony anchor for insertion into a bony segment comprising a bony anchor and a housing and a tower; wherein the tower has a plurality of separable members.

2. The separable bony anchor of claim 1 wherein the tower is integrally formed with the housing, but separable therefrom.

3. The separable bony anchor of claim 1 wherein the tower is external to the housing and is separable from and attachable to the housing.

4. The separable bony anchor of claim 1 wherein the tower separable members are a combination of members integrally formed and external to the housing and are separable from and attachable to the housing.

5. The separable bony anchor of claim 1 wherein the tower comprises two semi-annular extensions joined to the housing by a first.

6. The separable bony anchor of claim 5 wherein the extensions can be positioned about the first joint.

7. The separable bony anchor of claim 6 wherein the tower may be separated from the housing at the first joint.

8. The separable bony anchor of claim 7 wherein the tower comprises one or more additional joints configured to permit corresponding sections or portions of the tower to be positioned about the one or more additional joints.

9. The separable bony anchor of claim 8 wherein one or more of the corresponding sections of the tower are separable from the tower by separating at a corresponding joints.

10. The separable bony anchor of claim 1 wherein the tower can be positioned to provide one or more of the following:surgical access for visibility;visibility to the surgical site;surgical access for additional leverage;additional reductive correction; andintraoperative flexibility..

11. The separable bony anchor of claim 1 wherein the bony anchor comprises a proximal threaded section and distal threaded section, wherein the proximal section has one or additional thread starts in additional the threads in the distal section.

12. A multi-functional orthopedic tool adapted to perform multiple functions wherein the tool comprises a combination of features adapted for performing at least three orthopedic related function.

13. The multi-functional orthopedic tool of claim 12 adapted for manipulating a bony anchor comprising a bony anchor and a housing and for manipulating a rod for fixation; the tool comprising: a tool head comprising a two-pronged fork with an inward opposing pin on each fork prong adapted to engage indents on opposing outer surfaces of the housing and with a curved interface on each fork prong adapted for pushing on rods or rod-like connectors and with a section adapted for positioning a tower or housing.

14. The multi-functional orthopedic tool of claim 13 further comprising: an extended shaft;and a drive interface at the proximal end of the shaft; wherein the tool head is at the distal end of the shaft.

15. The multi-functional orthopedic tool of claim 12 in the form of separator tool for removing separable segments from the tower; wherein the tool comprises a pair of opposed protrusions at a separator end.

16. The multi-functional orthopedic tool of claim 15 wherein the protrusions are configured to not interfere with the tower as the tool is inserted down the tower, and to engage the tower when rotated.

17. The multi-functional orthopedic tool of claim 12 in the form of a manipulation tool having a handle and an engagement end with a semi-annular opening that engages the end of a tower, enabling the tower to be manipulated.

18. The multi-functional orthopedic tool of claim 17 further comprising a cutting edge.

19. The multi-functional orthopedic tool of claim 17 further comprising a visual aid.

20. The multi-functional orthopedic tool of claim 12 in the form of a retractor comprising a visual aid.

21. A tool for manipulating a separable bony anchor comprising a bony anchor and a housing and a tower; the tool comprising: a first drive interface at a distal end adapted to engage a head of the bony anchor; and a second drive interface at a proximal end adapted engage a head of the bony anchor and to be engaged by a driver, and a shaft extending between he proximal and distal end adapted to drive the bony anchor therein.

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