System and method for stabilizing pedicle screw of vertebral vertebrae

Abstract

This invention provides embodiments and methods of a system for stabilizing the vertebrae through a skin incision. [Solution] In some embodiments, the system or method may comprise a first screw 2202 having a first screw head, a second screw 2204 having a second screw head, a third screw 2206 having a third screw head, a first tower 2212 having a distal portion, a proximal portion, and a bend between the distal and proximal portions, a second tower 2214 having a distal portion and a proximal portion, the second tower being configured to be removably coupled to the second screw at the distal end of the second tower, and a third tower 2216 having a distal portion, a proximal portion, and a bend between the distal and proximal portions.

Description

Technical Field

[0001] Priority Claim and Incorporation by Reference This application claims priority to U.S. Patent Application No. 62 / 187,859, filed May 12, 2021, entitled "SYSTEMS AND METHODS FOR PEDICLE SCREW STABILIZATION OF SPINAL VERTEBRAE", the content of which is hereby incorporated by reference in its entirety as if fully set forth herein. The benefit of priority is claimed under appropriate legal standards including, but not limited to, under 35 U.S.C. § 119(e). Any and all applications in which foreign or domestic priority claims are identified in the application data sheet filed herewith are hereby incorporated by reference in their entirety and made a part of this specification. This application also claims priority to International Patent Application No. PCT / US2020 / 059547, filed November 6, 2020, entitled "SYSTEMS AND METHODS FOR PEDICLE SCREW STABILIZATION OF SPINAL VERTEBRAE", which claims priority to U.S. Patent Application No. 62 / 933,321, filed November 8, 2019, entitled "SYSTEMS AND METHODS FOR PEDICLE SCREW STABILIZATION OF SPINAL VERTEBRAE", the content of each of which is hereby incorporated by reference in its entirety as if fully set forth herein.

[0002] Embodiments of the present disclosure relate to devices, systems, and methods for treating the spine, including, but not limited to, devices, systems, and methods for stabilizing adjacent vertebrae within at least the cervical, thoracic, and lumbar-sacral vertebrae.

Background Art

[0003] While some lower back conditions can be improved with non-surgical approaches, spinal fusion is recommended for certain conditions when non-surgical approaches fail. Non-surgical approaches include pharmacotherapy, physiotherapy, chiropractic treatment, traction, epidural steroid injections, small articular surface blocks or nerve root transection, weight loss, smoking cessation, and acupuncture. Conditions that generally serve as indications for spinal fusion or stabilization surgery can generally be divided into three categories: (i) trauma-induced, (ii) curvature, and (iii) degenerative.

[0004] Traumatic conditions include fractures and ligament injuries. Fractures typically result from unfortunate accidents involving external force or falls, but can also arise from pathological conditions such as cancer or osteoporosis. Fractures are often compressive in nature and typically lead to pathological curvature of the spine, resulting in a loss of the natural lordosis (forward curvature) in the lumbar and cervical spine, known as kyphosis. Spinal fractures can also be caused by translational or rotational forces perpendicular to the axis of the spine. These forces result in fractures of the small articular surfaces or interarticular parts. If the external force is sufficiently large, the vertebra can collapse, potentially leading to a burst fracture that can damage all three columns of the vertebra (anterior, middle, and posterior columns). Many traumatic injuries can heal without surgery, but unstable injuries that carry a risk of neurological injury and / or pain require stabilization through procedures such as immobilization.

[0005] Spondylolisthesis, a condition characterized by the slippage of the bones or vertebrae of the spine, can result from a fracture of the interarticular portion (partial fracture) known as spondylolysis. Spondylolisthesis can also arise from pathological conditions such as malformations of the facet joints due to degenerative arthritis, as well as congenital malformations and tumors. When both parts are fractured, the spinous process and vertebral arch are essentially completely separated from the pedicle and vertebral body. This large fragment is called the body of Gill. Partial fractures are actually common in people of all ages (often developing in teenagers). Many of these patients have mild symptoms and do not require surgery, but those with progressive symptoms may require surgical decompression with or without fixation. Spondylolisthesis results in misalignment of the spine and increases the risk of nerve entrapment. Nerves travel within the spinal canal, which is bordered by the vertebrae, and the nerve roots protrude through curved openings on the sides of the vertebrae called foramina (singular: foramen). These spinal nerves are suspected to cause back pain and radiculopathy when they are trapped or when their nerve endings are irritated by irregular or abrasive movements around the intervertebral discs, bones, or joints. Spondylolisthesis can also exacerbate or be associated with degeneration of the intervertebral discs or facet joints, which can lead to axial back pain.

[0006] Normal curvature of the lumbar and cervical spine is lordosis, and the posterior surfaces of these vertebral levels form a concave curve. The thoracic spine usually has kyphosis or convex curvature. Curvature conditions include correction of natural curvature, as well as lateral / rotational flexion referred to as abnormal lordosis, abnormal kyphosis, or scoliosis. Curvature conditions can occur idiopathically during adolescence (e.g., idiopathic adolescent scoliosis) or develop as a secondary problem in conditions of abnormal spinal muscle activation (e.g., cerebral palsy, spina bifida, or tethered spinal cord syndrome). Abnormal spinal curvature is common in spinal degeneration when the intervertebral discs and joints degenerate asymmetrically as the biomechanical state of the spine is destroyed, resulting in progressive curvature (scoliosis, kyphosis, or lordosis). Curvature can also occur after trauma involving compression or burst fractures or ligament injuries. In addition, curvature can occur iatrogenically after previous spinal surgery that altered the anatomical structure and biomechanical state of the spine. Such situations include the removal of the posterior tension zone after laminectomy, and changes in physiological migration after spinal fusion, leading to adjacent level compensation and degeneration. Curvature results in abnormal biomechanical stress on the intervertebral discs and facet joints, often accompanied by compensatory measures such as intervertebral or ligament hypertrophy. Patients may develop both axial back pain and radiculopathy. Surgery may be effective in patients who have failed conservative treatment and bracing. Surgical procedures for these conditions include decompression of nerve or spinal cord compression, as well as fixation or stabilization. Curvature can be corrected surgically, and fixation prevents further curvature.

[0007] Degenerative conditions include spondyloarthritis and recurrent disc herniation. Spondyloarthritis is the most common indication for fusion surgery and can exist in the form of severe disc degeneration (also known as degenerative disc disease, DDD) or minor articular surface disease. Degenerative arthritis can also cause spondylolisthesis in addition to the traumatic fractures mentioned above. Degenerative conditions generally involve nerve compression that causes radicular pain in the distribution of the nerve's receptive field, which usually correlates with and manifests as pain in the arm or leg. Pure nerve compression syndromes, such as nucleus pulposus herniation (disc herniation) or foraminal stenosis (narrowing of the lateral intervertebral foramen canal through which the nerve passes), can often be treated with decompression without fusion. Pure disc degeneration syndromes can be treated with fusion without nerve decompression. However, most commonly, disc degeneration occurs in combination with nerve compression that causes both axial back pain and radiculopathy. In these situations, fusion surgery is combined with nerve decompression surgery.

[0008] Fixation functions to eliminate movement of the intervertebral disc space and facet joints between adjacent vertebrae. The vertebrae provide the rigid structural framework of the spine, and the fibrocartilaginous intervertebral disc space acts as a cushion or shock absorber. Deterioration of the intervertebral disc space can distort alignment and alter the biomechanical cushioning that the disc provides to adjacent vertebrae. This deterioration alters the force that impacts the vertebrae, resulting in axial back pain. Fixation is designed to eliminate movement between adjacent vertebrae by either forming a solid bridge of bone across the intervertebral disc space and / or generating new bone formation in the posterolateral space to provide stabilization, rigidity, and strength. Sometimes, fixation involves bone grafts harvested from another location within the body (e.g., autografts from the iliac crest in the pelvis) or bone grafts harvested from an external source, such as an allograft. Physicians generally refer to the level of fixation. Single-level fixation involves stabilizing two vertebrae adjacent to the affected intervertebral disc. Two-level fixation involves stabilizing three adjacent vertebrae spanning two problematic intervertebral disc spaces. Each vertebra contacts (joins) the adjacent vertebra at three points, with the paired facet joints located posteriorly and the intervertebral discs located anteriorly. Therefore, lumbar fusion can target either the posterior facet joints or the anterior interbody / discal space, or both. When anterior interbody fusion is performed in combination with posterior fusion, the procedure is referred to as 360° fusion. One commonly used posterolateral fusion is pedicle screw fusion, in which a screw is oriented into the pedicle portion and the body of the adjacent vertebra, and then a rod is connected to the screw across the intervertebral disc space. The screw and rod hold the adjacent vertebrae immobile relative to each other and allow bone grafts placed in either the interbody (discal) space or the posterolateral space to grow into solid bone. Conventional pedicle screws and rods are made of metal, typically titanium (Ti) alloys, but are also made from stainless steel, cobalt-chromium, and molybdenum-rhenium. Recently, rods have been made from minimally flexible polymers called polyetheretherketone (PEEK). Other metals are also used and can be employed. These may include, for example, cobalt, molybdenum, and other metals as well as non-metallic polymers.

[0009] Newer lumbar pedicle screw techniques involve placing screws through a midline incision and placing them superiorly and laterally, instead of the typical trajectory that medically starts laterally through the pedicle and targets the vertebral body. This technique is named cortical trajectory (CBT) because the screw trajectory crosses more cortical bone as opposed to cancellous bone. Cortical bone is typically harder and therefore provides greater traction strength. Thus, cortical trajectories allow for smaller and shorter screws using a single midline incision instead of bilateral Wirtz incisions. The issue with CBT screw trajectories is that superior screws in lumbar fusion, such as the L4 trajectory in L4 and L5 TLIF surgeries, have a more superior and laterally oriented trajectory rather than a medical trajectory. Inferior screws may have a trajectory parallel (rather than superior) in the sagittal plane, or a more linear trajectory. This configuration causes a natural intersection of the upper and lower screws, as the upper screw is oriented upward, and therefore the minimally invasive spinal (MIS) screw mounted on the tower has a downward-facing tower because the screw is oriented upward. Since the trajectory is not as upward while the lower screw is oriented, the towers mounted on these two screws are constrained to interfere with each other. Furthermore, since the incision is on the midline and the screws are oriented from medial to lateral, the screws from the ipsilateral and contralateral sides are also constrained to intersect. Thus, the cortical bone trajectory is a technique that benefits from towers mounted on screws that do not interfere with each other due to the fact that they have interfering trajectories.

[0010] Interbody fusion involves the removal of a degenerated intervertebral disc and the subsequent placement of one or more spacers (typically pre-filled with bone graft material) into the intervertebral (disc) space between the vertebral bodies. Spacers are made from bone grafts, titanium, carbon fiber, or polymers such as PEEK. Interbody fusion can be performed through several approaches, including anterior approaches (anterior lumbar interbody fusion, ALIF), posterior approaches (posterior lumbar interbody fusion, PLIF, or transforaminal lumbar interbody fusion, TLIF), or lateral approaches (direct lateral interbody fusion, DLIF®-Medtronic, or translateral lateral interbody fusion, XLIF®-Nuvasive). The objective of these approaches is to remove the degenerated intervertebral disc and replace it with a material that induces bone fusion. Alternatively, the intervertebral disc can be replaced with a prosthetic joint / disc (described below). Each of these intervertebral approaches has its advantages and disadvantages. The anterior approach allows for very large spacers with a great degree of lordosis, but requires retroperitoneal incision and carries the risk of damaging major blood vessels anterior to the lumbar spine. Furthermore, damage to the nerve plexus anterior to the vertebra can result in sexual dysfunction. The lateral approach also allows for very large spacers, and some lordosis is limited to the upper and middle lumbar levels (rostral relative to L5, S1) due to obstruction by the iliac crest. The posterior intervertebral approach is more time-consuming and typically requires more myotomy and incision. However, the posterior approach allows for intervertebral graft placement, posterior pedicle screw fixation, and nerve decompression all to occur through the posterior incision(s).

[0011] Anterior and lateral approaches can be performed independently (without posterior instruments), but many surgeons back up or complement anterior or lateral interbody fixation by placing pedicle screws posteriorly after the interbody cage or graft has been placed. This 360° fixation restricts movement and increases the fixation speed more than simply isolated anterior or posterior fixation. However, in the case of ALIF and lateral interbody fixation (DLIF®, XLIF®), two sets of incisions are required for 360° fixation.

[0012] Posterior approaches (TLIF and PLIF) allow interbody fusion, pedicle screw fusion, and nerve decompression to be performed all through the same posterior incision (multiple possible). In TLIF, after nerve decompression is complete, a single large interbody spacer is inserted ipsilateral to the patient's symptomatic side. If both sides are symptomatic, decompression is required on both sides. PLIF is performed by placing two interbody spacers, one on each side. Posterior procedures may be performed according to (i) invasive open procedures with large and / or multiple incisions, (ii) percutaneous approaches with small and / or multiple incisions, and potentially (iii) endoscopic approaches with small incisions and all tools and devices inserted through a portal with visualization provided on an external monitor.

[0013] As an alternative to fusion surgery, recent advances in intervertebral stabilization have led to the development of artificial disc technology. Artificial discs replace degenerated discs and allow for continuous movement at the joint. Artificial discs for the cervical and lumbar spine have been developed. In addition, dynamic stabilization techniques for the posterior spine have been developed. These posterior techniques utilize pedicle screws and dynamic rods. Typically, dynamic rods have a mechanism that flexes under a specific load or force, thereby absorbing some of the stress and strain applied to the spine. The advantage of dynamic stabilization is that movement is preserved within the spine. However, the durability of these systems can be an issue. In fusion surgery, bone grafts (intervertebral or posterolateral) ultimately fix the vertebrae, eliminating the need for spinal devices (screws and rods). However, in dynamic stabilization, fusion does not occur, and therefore the screws and dynamic rods are constantly subjected to spinal strain and forces. Over time, the possibility of pedicle screw loosening or mechanical failure may increase. Sometimes, the use of slightly flexible rods, such as those made from PEEK, can actually increase fixation by reducing stress shielding. Stress shielding occurs when a rigid fixation structure shields the vertebra in contact with the bone graft from the stresses necessary for bone formation and reconstruction.

[0014] Posterior lumbar stabilization (fixation and dynamic stabilization) techniques have evolved into minimally invasive approaches, as such minimal exposure reduces patient morbidity and facilitates functional recovery. Blood loss and hospital stays are shorter. The process for minimally invasive pedicle screw fixation is the same as the process for dynamic stabilization and involves two basic parts. First, the screw is percutaneously placed into the vertebral body through the pedicle. In minimally invasive systems, the cannula-inserted screw is percutaneously placed on a guidance element guided by fluoroscopy (X-rays viewable on a video screen). Recent advances have also made it possible to place either cannula- or non-cannula-like screws using intraoperative navigation, robotic guidance, or virtual reality guidance. Generally, two screws are used for each vertebra to be fixed, one on the right side and the other on the left. Single-level fixation involves connecting adjacent vertebral bodies at the intervertebral disc level to be fixed. For example, L5, S1 fixation requires screws, usually placed bilaterally at L5 and S1, to fix the L5 and S1 intervertebral discs. The second part of the process involves connecting the screws to a rod and locking the rod and screw together. In dynamic stabilization, the rod or rod-like device (flexible connector) is bendable, but the process of inserting this bendable rod is the same as in fixation. For example, a rod-like device (flexible connector) fits into the screw head but may also include elements that allow for some movement (buffers, springs, etc.). Variations between different minimally invasive systems mainly arise in the method of placing the rod through a minimal incision and locking the rod with a screw.

[0015] Before inserting an intervertebral spacer, the damaged or degenerated disc within the intervertebral disc space must be removed. In the TLIF approach, the intervertebral disc space is accessed through a spondyloarthrectomy, where a hole around the nerve root is opened using a bone-cutting tool such as a bone knife or high-speed drill. In the PLIF approach, a laminectomy or laminotomy is performed to access the intervertebral disc space. Both TLIF and PLIF allow decompression of the spinal sac and nerve root, but the spondyloarthrectomy in TLIF allows for maximum decompression of the existing nerve root on that side. The intervertebral disc space is easily accessed by gently opening the sac. The discectomy can then be completed by inserting instruments used to remove the degenerated disc into the intervertebral disc space.

[0016] Following the removal of the intervertebral disc, the surgeon needs to prepare the bone surface known as the endplate of the vertebral body on each side of the removed disc. Removing the endplate using instruments such as curettes induces bleeding, which stimulates the healing and assimilation of the bone graft to be inserted into the intervertebral space. The spacer or cage to be inserted is typically constructed from bone, titanium, carbon fiber, or a polymer such as PEEK. The spacer is usually hollow or at least porous to accommodate the bone graft material within it. Osteogenic proteins, such as bone morphogenesis proteins (BMPs), are also generally implanted within the spacer. After the spacer and bone graft have been implanted, a rod can be inserted into the pedicle screw, and the screw can be tightened to lock the rod in place.

[0017] Pedicle screw fixation procedures such as TLIF can be performed openly, either through a single large incision or through a minimally invasive (MIS) approach with smaller incision sizes and less tissue damage or injury. MIS TLIF typically uses percutaneous pedicle screws, each screw being placed through a small incision just outside the diameter of the screw head or the side of the largest screw insertion tool. Typically, percutaneous screw placement is straightforward because the screws are long and thin and are either screwed directly into the bone through the tissue or on a guidewire placed using stereotactic navigation, sometimes with the help of a surgical robot. In the open approach, screws are placed using visually identified anatomical landmarks and fluoroscopy guidance, although navigation and robot guidance can also be useful in the open case. Since percutaneous pedicle screws are placed through a small incision that is barely large enough to accommodate the screw or screw insertion tool, visual landmarks are virtually unavailable. There is a mini-open approach in which a visual landmark for pedicle screw placement can be identified through a small incision using either a microscope or endoscope, or through either a small tubular retractor or endoscope. Importantly, once the location of the pedicle screw canal is identified and a guidewire is placed in the pedicle screw canal, it is relatively easy to place the percutaneous pedicle screw on the guidewire. Stereotactic navigation and robotic guidance also make pedicle screw placement relatively easy.

[0018] In most minimally invasive surgical (MIS) systems used today, a guidance element, such as a wire or guidewire, is placed percutaneously through the pedicle under fluoroscopic guidance. Recent advances have also made it possible to place either cannular or non-cannular screws using intraoperative navigation, robotic guidance, intraoperative CT, or virtual reality guidance. These methods also allow for precise placement of pedicle screws directly, without guidewires or cannula insertion. When guidewire systems are used, percutaneous cannular drills and screw taps are inserted via the guidance element / wire to prepare a channel through the pedicle and vertebral body for pedicle screw insertion. Dilatation tubes and guide tubes or retractor systems may often be used to dilate and keep open the pathway around the guidance element through the skin and muscle to reduce muscle and tissue damage when the pedicle screw and insertion tool are inserted. The pedicle screw is inserted over the guidance element, with or without passing through the guide tube / retractor. Here too, for the development and widespread use of intraoperative navigation to guide the placement of pedicle screws, some pedicle screws can be placed without the use of pre-drilling of holes or guide wires. These systems use intraoperative navigation to directly place pedicle screws into bone through tissue without pre-drilling or tapping holes. Furthermore, robotic arms may also be used, in addition to, and often in combination with, navigation systems to assist in the precise placement of pedicle screws.

[0019] In MIS pedicle screw fixation, after the pedicle screws have been inserted, there remains a crucial step in connecting the screw heads using rods and locking caps to lock adjacent screws. Inserting the rods that connect the screw heads and the locking caps to lock the rods inside the screw heads is currently one of the most challenging steps using the MIS approach through minimal incisions. To secure the rod and locking assembly within the screw head, each screw head is associated with a blade or tower extending upward from the screw head through the skin incision. The tower must accommodate the rod and locking assembly and is therefore typically the same size as, or larger than, the maximum diameter of the screw head. Once the screw-mounted tower is in place, the rod is inserted by one of several methods. A leading MIS system is Medtronic's Sextant™, in which the rod is secured by forming a pendulum-like mechanism. Two or three towers (each for fixing one or two levels) are joined together to align the towers, and the rod is swung in a pendulum-like manner through separate incisions above or below the towers. When the rod is swung into place, a locking cap is secured and tightened through the tower. Alternatively, most existing systems insert the rod through one of the towers and then rotate the rod approximately 90° to capture another screw in the other tower. Inserting the rod through the screw head in minimally invasive systems is done blindly, for example, without direct visualization of the screw head. Therefore, this process can be tedious and frustrating.

[0020] Both the Sextant™ system and other existing systems using towers are hampered by the number of incisions required. Using a separate tower for each screw requires a separate incision for each tower, or a single incision long enough to accommodate two towers. The Sextant™ system also requires additional incisions for the rods, which is equivalent to six incisions (three on each side) for single-level fixation and eight incisions for two-level fixation. Other existing tower systems using direct rod insertion and rotation mechanisms still require one incision for each screw, and each incision must be larger than the size of the tower into which the screw is inserted. Typically, each incision is at least 15 mm long. When the lengths of all incisions on both sides are added together, the total length of current major minimally invasive systems is often longer than the single midline incision of a conventional “open” approach for single or two-level pedicle screw fixation.

[0021] Furthermore, none of the current MIS pedicle screw systems are designed to take advantage of the lumbar lordosis that is typically present in most patients. Approximately 80% of lumbar pedicle screw fixation is performed at the two lowest levels, L4–L5 and L5–S1. These lowest lumbar levels also exhibit the strongest lumbar lordosis, typically so that the pedicle screw canals passing through L4, L5, S1, and even L3, often cross near a single point near the skin, much like spokes on a bicycle tire. In most pedicle screw systems, this lumbar lordosis is an obstacle where all the towers of the pedicle screw cross. Tower crossing makes it difficult for these MIS screw systems to allow the rod to be placed through the tower channels.

[0022] U.S. Patent No. 7,306,603, “Device and method for percutaneous placement of lumbar pedicle screws and connecting rods,” by Frank H. Boehm, Jr. et al., assigned to Innovative Spinal Technologies, Inc. (Mansfield, Massachusetts), is incorporated herein by reference in its entirety, disclosing a system for connecting rods to pedicle screws using pins and recesses within the screw head. According to this system, the rod can pivot about the longitudinal axis of the pin between a first position where the rod is parallel to the longitudinal axis of the screw (e.g., oriented perpendicularly) and a second position where the rod traverses its axis to bridge screws on adjacent vertebrae. Patent No. 603 teaches various guide systems (see Figures 5 and 6), rod holder systems (see Figures 8, 9, 10, and 11), and rod guide systems (see Figure 12), none of which include a smooth, removable system. Rather, the illustrated system is tower-like, with a very bulky expander (80 and 86 in Figures 6 and 8), a sheath (81 in Figure 6), and / or an outer housing (120 in Figures 11 and 12). U.S. Patent Application Publication 2008 / 0140075, “Press-On Pedicle Screw Assembly,” by Michael D. Ensign, assigned to Alpinespine LLC (American Fork, Utah), which is incorporated herein by reference in its entirety, discloses indirectly attaching a rod to a screw head via a tulip assembly. The tulip assembly has a housing with an inner diameter smaller than the inner diameter of the screw head so that it can be easily pressed into place on the screw head. The rod is then secured by attaching the tulip assembly directly to the tulip assembly after connecting it to the screw head.This publication refers to the use of Kirschner guidance elements (or K guidance elements) to insert both the pedicle screw and the tulip member (see

[0030] ,

[0032] ,

[0045] ), but does not disclose how the rod is guided into place.

[0023] U.S. Patent Application Publication No. 2008 / 0097457 by David R. Warnick, entitled “Pedicle screw systems and methods of assembling / installing the same” (published in its entirety by reference as in '075), also discloses the use of a tulip assembly as an intermediary for joining a rod to a screw. In this system, the structure is tightened by rotating the inner member and outer housing of the tulip assembly relative to each other, rather than by a press-lock mechanism.

[0024] U.S. Patent No. 7,179,261, “Percutaneous access devices and bone anchor assemblies,” by Christopher W. Sicvol et al., assigned to Depuy Spine, Inc., which is incorporated herein by reference in its entirety, describes one of several tower systems for percutaneous placement of pedicle screws. The patent describes a situation in which the angles of the screws intersect and the towers may interfere with each other. This situation is fairly typical in lordotic lumbar spine, particularly at the lumbosacral (L5,S1) joint. To solve this problem, they describe providing notches in the tubes so that two tubes can intersect. Given that the angle of the vertebrae varies from patient to patient and the depth of the vertebrae from the skin also varies considerably, there must be a number of notch variations. In addition, as shown in Figure 22B of Patent No. 261, when two tubes intersect at a notch, the edge of the notch in one tube interferes with or obstructs the lumen of the other tube, and vice versa. This occurs because the muscles and tissues surrounding the tubes push them together at the notch, thereby significantly reducing the lumen into which the rod and other elements are inserted. The only way to avoid this interference or obstruction of the lumen is to leave the tubes separated, which requires a larger incision and eliminates the need for a notch in the first location. Furthermore, two or three levels of fixation requiring three or four screws that can intersect become problematic if the towers on the screws intersect. [Overview of the project]

[0025] Some embodiments described herein relate to systems, devices, and / or methods for bone stabilization, such as for stabilizing the spine. In some embodiments, one or more guidance elements may be provided, which may also be referred to herein as guidance elements, guide elements, towers, or extensions, or other terms as described herein. Guidance elements may be connectable, attachable, and / or engageable with bone screws, such as pedicle screws. In some embodiments, these guidance elements can be used to deliver connecting members, such as rods, to bone screws implanted in the patient's vertebrae. Additional systems, devices, and methods, including but not limited to rod insertion devices and guidance tools for drills, are described herein. Each of the systems, methods, and devices of this disclosure has multiple innovative embodiments, implementations, or forms, and no single embodiment among them may alone assume the desired attributes disclosed herein.

[0026] Some embodiments of the bone stabilization systems disclosed herein include a first guide element comprising an elongated body having a first longitudinal axis, a proximal end, and a distal end, the distal end of which is configured to engage with a first bone screw; a second guide element comprising an elongated body having a second longitudinal axis, a proximal end, and a distal end, the distal end of which is configured to engage with a second bone screw; and an opening provided in the middle portion of the first guide element when in use. In some embodiments, the opening may be sized and configured to allow the second guide element to pass through it such that the second longitudinal axis is at a certain angle with respect to the first longitudinal axis, and the opening may be sized and configured to restrict the movement and / or rotation of the second guide element along the first longitudinal axis relative to the first guide element.

[0027] Embodiments of a system for stabilizing a spinal vertebra through a skin incision are disclosed herein. In some embodiments, the system can include a first screw having a first screw head, a second screw having a second screw head, a third screw having a third screw head, a first tower having a distal portion, a proximal portion, and a bend between the distal and proximal portions, a second tower having a distal portion and a proximal portion, wherein the second tower is configured to be removably coupled to the second screw at the distal end of the second tower, and a third tower having a distal portion, a proximal portion, and a bend between the distal and proximal portions.

[0028] Any embodiment of the devices, systems, and methods disclosed herein may, in additional embodiments, include one or more of the following features, components, and / or details in any combination with any other features, components, and / or details of any other embodiment of the devices, systems, and methods disclosed herein, wherein a first tower may be configured to be detachably coupled to a first screw at the distal end of the first tower; a third tower may be configured to be detachably coupled to a third screw at the distal end of the third tower; the first tower may be configured to be detachably coupled to a first screw such that when the first tower is coupled to the first screw, the axial centerline of the distal portion of the first tower is substantially collinear with the axial centerline of the first screw; and the second tower may be configured to be detachably coupled to a first screw such that when the second tower is coupled to the second screw, the distal end of the second tower is substantially collinear with the axial centerline of the first screw. The first, second, and third towers are configured to be removably coupled to the second screw such that the axial centerline of the first tower is substantially collinear with the axial centerline of the second screw when the third tower is coupled to the third screw, the axial centerline of the distal portion of the third tower is substantially collinear with the axial centerline of the third screw, the proximal portion of the first tower extends at a non-zero acute angle away from the axial centerline of the distal portion of the first tower, the proximal portion of the third tower extends at a non-zero acute angle away from the axial centerline of the distal portion of the third tower, and in the operational state, the first, second, and third towers are configured to intersect each other, and / or the proximal portion of one or more of the towers (e.g., the first and third towers or extensions, but not limited to) is configured to be compatible with grippers, coupling mechanisms, and other components of a surgical robot system.

[0029] Embodiments of a system for stabilizing vertebral bones through a skin incision are also disclosed herein. In some embodiments, the system may include a first screw having a first screw head, a second screw having a second screw head, a third screw having a third screw head, a first tower having a distal portion and a proximal portion, a second tower having a distal portion and a proximal portion, the second tower being configured to be removably coupled to the second screw at the distal end of the second tower, and a third tower having a distal portion and a proximal portion.

[0030] Any embodiment of the devices, systems, and methods disclosed herein can, in additional embodiments, include one or more of the following features, components, and / or details in any combination with any of the other features, components, and / or details of any other embodiment of the devices, systems, and methods disclosed herein. The first tower can be configured to be removably coupled to a first screw at a distal end of the first tower. The third tower can be configured to be removably coupled to a third screw at a distal end of the third tower. The first tower is configured to be removably coupled to the first screw such that when the first tower is coupled to the first screw, an axial centerline of a distal portion of the first tower is substantially collinear with an axial centerline of the first screw. The second tower is configured to be removably coupled to the second screw such that when the second tower is coupled to the second screw, an axial centerline of a distal portion of the second tower is substantially collinear with an axial centerline of the second screw. The third tower is configured to be removably coupled to the third screw such that when the third tower is coupled to the third screw, an axial centerline of a distal portion of the third tower is substantially collinear with an axial centerline of the third screw. A proximal portion of the first tower extends at a non-zero acute angle away from an axial centerline of a distal portion of the first tower. A proximal portion of the third tower extends at a non-zero acute angle away from an axial centerline of a distal portion of the third tower. In an operable state, the proximal portion of the first tower extends away from the second tower in a first direction and / or in an operable state, the proximal portion of the third tower also extends away from the second tower in the first direction.

[0031] Disclosed herein are embodiments of a method for stabilizing a vertebral column. In some embodiments, the method may include: embedding a first screw, connected to a first tower, into a first vertebra through an incision; advancing a second tower, connected to a second screw, through an opening formed in the first tower, to embed the second screw into the second vertebra; advancing a third tower, connected to a third screw, through an opening formed in the first tower, to embed the third screw into the third vertebra; and moving the proximal portion of the first tower toward the proximal portion of the third tower, thereby moving the first vertebra from a first position relative to the third vertebra to a second position relative to the third vertebra.

[0032] Disclosed herein are embodiments of a method for stabilizing a vertebral bone. In some embodiments, the method involves implanting a first screw, coupled to a first extension, into a first vertebra through a single incision, wherein the first extension has a proximal portion and a distal portion, and advancing a second extension, coupled to a second screw, through a single incision and a first opening formed in the first extension, such that the axial centerline of at least the distal portion of the second extension is at an acute angle with respect to the axial centerline of at least the distal portion of the first extension. This may include: embedding the second screw into the second vertebra; advancing the third extension, which is connected to the third screw, through a single incision and a first opening formed in the first extension, such that the axial centerline of at least the distal portion of the third extension is at an acute angle with respect to the axial centerline of at least the distal portion of the first extension, and at an acute angle with respect to the axial centerline of at least the distal portion of the second extension; and embedding the third screw into the second vertebra.

[0033] Any embodiment of the devices, systems, and methods disclosed herein may, in additional embodiments, include one or more of the following features, components, and / or details in any combination with any other features, components, and / or details of any other embodiment of the devices, systems, and methods disclosed herein, wherein in the operational state, the first, second, and third towers are configured to intersect at or adjacent to the patient's skin level, and in the operational state, the first, second, and third towers are, The towers are configured to intersect while embedded at or adjacent to the patient's skin level, with the distance from the skin level to the nearest end of the distal portion of the first tower being 10% or less of the length of the distal portion of the first tower, and the distance from the skin level to the nearest end of the distal portion of the third tower being 10% or less of the length of the distal portion of the third tower, and the first tower is sized and configured to receive the second and third towers internally such that, in the operational state, a portion of the outer wall of the first tower surrounds the outer surfaces of portions of the second and third towers. The first tower has an opening inside, the opening extending at least through the proximal end of the distal portion of the first tower, the opening extending along the first tower to an edge adjacent to the proximal end of the distal portion of the first tower, the proximal portion of the first tower is configured to extend at a non-zero acute angle away from the axial centerline of the proximal portion of the second tower such that, in the operational state of the system, the proximal portion of the first tower forms an acute angle with respect to the proximal portion of the second tower, and the distal portion of the first tower is configured such that, in the operational state of the system, the first The distal portion of the first tower is configured to extend at a non-zero acute angle away from the axial centerline of the distal portion of the second tower such that the distal portion of the first tower forms an acute angle with respect to the distal portion of the second tower, and the proximal portion of the third tower is configured to extend at a non-zero acute angle away from the axial centerline of the proximal portion of the second tower such that the proximal portion of the third tower forms an acute angle with respect to the proximal portion of the second tower in the operational state of the system, and the distal portion of the third tower is configured to extend at a non-zero acute angle away from the axial centerline of the proximal portion of the second tower in the operational state of the system,The distal portion of the third tower is configured to extend at a non-zero acute angle away from the axial centerline of the distal portion of the second tower, such that the distal portion of the third tower forms an acute angle with respect to the distal portion of the second tower, and / or the distal portions of the first tower and / or the third tower have a curved cross-sectional profile, while the proximal portions of the first tower and / or the third tower have a flat or rectangular cross-sectional profile.

[0034] Any embodiment of the devices, systems, and methods disclosed herein may, in additional embodiments, include one or more of the following features, components, and / or details in any combination with any other features, components, and / or details of any other embodiment of the devices, systems, and methods disclosed herein, wherein the first tower, when embedded, is sized such that the proximal portion of the first tower extends away from the skin incision in a first direction, and the proximal portion of the third tower also extends away from the skin incision in a first direction. The first tower is sized and configured such that, in its operational state, the proximal portion of the third tower is positioned between the proximal portion of the first tower and the proximal portion of the second tower, and in its operational state, the proximal portion of the first tower extends away from the skin incision in a first direction, and the proximal portion of the third tower also extends away from the skin incision in a first direction, and the distal portion of the first tower extends away from the first screw to a height directly below the skin incision or to the same height as the patient's skin when the first screw is fully embedded in the first vertebra. The proximal portion of the first tower is configured to be grasped by the surgeon so that the surgeon can apply a counter-torque force to the first tower around at least the axial centerline of the distal portion of the first tower, and in the operational state, the proximal portion of the third tower is configured to be grasped by the surgeon so that the surgeon can apply a rotational force to the third tower around at least the axial centerline of the distal portion of the third tower, and in the operational state, the system is configured to move the proximal portion of the first tower toward the proximal portion of the third tower. The system is configured to generate a compressive force on the first vertebra in which the first screw is embedded relative to the third vertebra in which the third screw is embedded, and the first and third towers are sized and configured such that when the first screw is embedded in the first vertebra, only the proximal portions of the first and third towers are outside the skin incision, and the system is configured such that the first, second and third screws are embedded through the same skin incision, and the proximal portion of the first tower is approximately the same length as the distal portion of the first tower,The first tower has a length that is at least 80% of the length of the distal portion of the first tower, the proximal portion of the first tower is removably coupled to the distal portion of the first tower, the proximal portion of the third tower is removably coupled to the distal portion of the third tower, the proximal portion of the first tower is non-removably coupled to the distal portion of the first tower, the proximal portion of the third tower is non-removably coupled to the distal portion of the third tower, the proximal portion of the first tower is integrally formed with the body portion of the first tower, at least the distal portions of the first tower, the first tower, the second tower, and the third tower have a complete or partial tubular shape, the first tower has a pair of hooks configured to receive a pair of wires used during implantation, the hooks are on a surface from which the third tower can rotate The structure is configured to provide the following: the first tower has a projection that provides a pivot point for the rotation of the third tower relative to the first tower; the third tower may have an opening formed through a portion of the wall of the third tower, the opening allowing the second tower to pass through the opening of the third tower in the operational state; and at least a portion of the wall of the third portion may be configured to at least partially surround the outer surface of the second tower; the distal portions of the first tower and / or the third tower are open along one side thereof and not completely enclosed; and / or, in the operational state, the axial centerlines of both the distal portion of the third tower and the proximal portion of the third tower extend away from the axial centerline of the second tower at a non-zero angle in the same direction.

[0035] Any embodiment of the devices, systems, and methods disclosed herein may, in additional embodiments, include one or more of the following features, components, and / or details in any combination with any other features, components, and / or details of any other embodiment of the devices, systems, and methods disclosed herein, wherein at least the distal portions of the first tower and the third tower have adjustable lengths, and at least the distal portions of the first tower, the second tower, and the third tower are formed in a substantially cylindrical shape. The proximal portion of the first tower and the proximal portion of the third tower have a curved cross-sectional profile, the proximal portion of the first tower and the proximal portion of the third tower have a semicircular tubular cross-sectional profile, the proximal portion of the first tower and the proximal portion of the third tower have a planar shape, and the device, system, or method may include a rigid connecting element, a first receiving element coupled to a first screw head, a second receiving element coupled to a second screw head, and a third receiving element coupled to a third screw head, and the first, second, and third receiving elements are connected The connecting element is configured to operably receive a connecting element, and in the operable state, the connecting element extends between the first, second, and third receiving elements when the first, second, and third screws are embedded in the first, second, and third vertebrae, respectively, and the first tower has at least one opening extending through the side of its distal portion, configured to receive the connecting element configured to extend between the first, second, and third screws in the operable state, and the second tower is configured to receive the connecting element configured to extend between the first, second, and third screws in the operable state The third tower has at least one opening extending through the side of its body portion, and is configured to receive a connecting element configured to extend between the first, second, and third screws in an operable state, and the device, system, or method selectively covers the channels or openings of the first tower, second tower, and / or third tower, to increase the torsional or flexural stiffness of the first tower, second tower, and / or third tower,The device, system, or method may include one or more covers configured to selectively couple with and / or a third tower, and / or may include two or more of the first towers and / or two or more of the third towers, each of which two or more of the first towers defines a different angle between the proximal and distal portions of the first tower, and each of which two or more of the third towers defines a different angle between the proximal and distal portions of the third tower.

[0036] Any embodiment of the devices, systems, and methods disclosed herein may, in additional embodiments, include one or more of the following features, components, and / or details in any combination with any other features, components, and / or details of any other embodiment of the devices, systems, and methods disclosed herein, wherein in the operational state, the first, second, and third towers are configured to intersect at or adjacent to the patient's skin level, and the device, system, or method has a connecting element forward toward the first, second, and third threads. The device, system, or method may include advancing the first, second, and third extensions through a single incision in the patient's skin.

[0037] Any embodiment of the devices, systems, and methods disclosed herein may, in additional embodiments, include one or more of the following features, components, and / or details in any combination with any other features, components, and / or details of any other embodiment of the devices, systems, and methods disclosed herein, wherein the first extension is between the proximal and distal portions of the first extension such that the axial centerline of the proximal portion of the first extension is acute with respect to the axial centerline of the distal portion of the first extension. The first extension has a bend, and the third extension has a bend between the proximal portion of the third extension and the distal portion of the third extension such that the axial centerline of the proximal portion of the third extension is at an acute angle with respect to the axial centerline of the distal portion of the third extension, and / or the device, system, or method may include moving the proximal portion of the first extension toward the proximal portion of the third extension, rotating the first extension relative to the third extension, moving the first screw toward the third screw, thereby moving the first vertebra toward the third vertebra.

[0038] Some embodiments disclosed herein can be described as follows: 1. A system for bone stabilization, A first guide element comprising an elongated body having a first longitudinal axis, a proximal end, and a distal end, wherein the distal end is configured to engage with a first bone screw, A second guide element comprising an elongated body having a second longitudinal axis, a proximal end, and a distal end, wherein the distal end is configured to engage with a second bone screw, An opening provided in the middle portion of the first guide element when in use, the opening being sized and configured to allow the second guide element to pass through the opening such that the second longitudinal axis is at a certain angle with respect to the first longitudinal axis, and the opening being sized and configured to restrict the movement of the second guide element along the first longitudinal axis, A system that includes these features. 2. The system according to Embodiment 1, wherein the first and second guide elements each comprise a pair of blades. 3. The system according to Embodiment 2, wherein each pair of blades has one or more bends or curves to increase the separation distance between opposing blades when the pair of blades engage with a bone screw. 4. The system according to Embodiment 1, wherein the first and second induction elements include partial tubes. 5. The system according to any one of the above embodiments, wherein the opening is provided within the intermediate portion of the first guide element. 6. The system according to any one of embodiments 1 to 4, wherein the opening is provided by an external restraint configured to surround at least a first guide element. 7. A system for bone stabilization, A first guide element comprising an elongated body having a first longitudinal axis, a proximal end, and a distal end, wherein the distal end is configured to engage with a first bone screw, A second guide element comprising an elongated body having a second longitudinal axis, a proximal end, and a distal end, wherein the distal end is configured to engage with a second bone screw, The second guide element is configured such that the first and second guide elements engage with the first and second bone screws, respectively, and pass through a portion of the first guide element when the first and second bone screws are implanted in the patient. A means for restricting relative movement and creating a fulcrum between the first and second guide elements when the second guide element passes through a portion of the first guide element, the first and second guide elements engage with the first and second bone screws, respectively, and the first and second bone screws are implanted in the patient, A system that includes these features.

[0039] Some embodiments relate to screws having one or more of the features described above. Some embodiments relate to devices, systems, and / or methods as illustrated and / or described. Some embodiments relate to methods for operating any of the devices or systems described above. Further embodiments, described throughout the following description, include, but are not limited to, systems for stabilizing vertebrae, methods for stabilizing vertebrae, induction assemblies, screws, rod inserters, methods for operating any of the foregoing, and other devices, systems, and methods.

[0040] The accompanying drawings incorporated herein and forming part thereof illustrate embodiments of the present disclosure and, together with the general description given above and the detailed description of embodiments given below, are useful in illustrating the principles of the embodiments of the present disclosure. [Brief explanation of the drawing]

[0041] [Figure 1A] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1B] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1C] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw containing a hybrid guidance element, is shown. [Figure 1D] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1E] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1F] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1G]One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1H] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1I] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1J] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1K] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1L] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1M] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1N] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 10] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1P] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1Q] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1R] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1S] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1T] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1U] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1V] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1W] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1X] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1Y] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 1Z] One embodiment of a method and system for stabilizing a vertebral column, comprising a pedicle screw including a hybrid guidance element, is shown. [Figure 2A] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 2B] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 2C] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 2D] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 2E] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 2F] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 2G] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 2H] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 2I] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 2J] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 2K] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 2L] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 2M] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 2N] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 2O] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 2P] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 2Q] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 2R] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 2S] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 2T]Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 3A] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 3B] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 3C] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 3D] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 3E] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 3F] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 3G] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 3H] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 3I] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 3J] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 3K] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 3L] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 3M] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 3N] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 3O] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 4A] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 4B] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 4C] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 4D] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 4E] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 4F] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 4G] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 4H] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 4I] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 4J] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 4K] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 4L] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 4M] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 4N]Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 4O] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 4P] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 4Q] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 4R] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 4S] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 4T] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 5A] Another embodiment of a method and system for stabilizing vertebrae, including a spinal screw, is shown. [Figure 5B] Another embodiment of a method and system for stabilizing vertebrae, including a spinal screw, is shown. [Figure 5C] Another embodiment of a method and system for stabilizing vertebrae, including a spinal screw, is shown. [Figure 5D] Another embodiment of a method and system for stabilizing vertebrae, including a spinal screw, is shown. [Figure 5E] Another embodiment of a method and system for stabilizing vertebrae, including a spinal screw, is shown. [Figure 5F] Another embodiment of a method and system for stabilizing vertebrae, including a spinal screw, is shown. [Figure 5G] Another embodiment of a method and system for stabilizing vertebrae, including a spinal screw, is shown. [Figure 5H] Another embodiment of a method and system for stabilizing vertebrae, including a spinal screw, is shown. [Figure 5I] Another embodiment of a method and system for stabilizing vertebrae, including a spinal screw, is shown. [Figure 5J] Another embodiment of a method and system for stabilizing vertebrae, including a spinal screw, is shown. [Figure 5K] Another embodiment of a method and system for stabilizing vertebrae, including a spinal screw, is shown. [Figure 6A] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 6B] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 6C] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 6D] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 6E] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 6F] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 6G] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 6H] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 6I] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 6J] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 6K] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 6L]Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 6M] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 6N] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 6O] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 6P] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 6Q] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 6R] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 6S] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 6T] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 6U] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 6V] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 7A] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 7B] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 7C] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 7D] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 7E] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 7F] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 7G] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 7H] Another embodiment of a method and system for stabilizing vertebrae, comprising a spinal screw, is shown. [Figure 8A] Another embodiment of a method and system for delivering a spinal screw to a vertebral position is shown. [Figure 8B] Another embodiment of a method and system for delivering a spinal screw to a vertebral position is shown. [Figure 8C] Another embodiment of a method and system for delivering a spinal screw to a vertebral position is shown. [Figure 8D] Another embodiment of a method and system for delivering a spinal screw to a vertebral position is shown. [Figure 8E] Another embodiment of a method and system for delivering a spinal screw to a vertebral position is shown. [Figure 8F] Another embodiment of a method and system for delivering a spinal screw to a vertebral position is shown. [Figure 8G] Another embodiment of a method and system for delivering a spinal screw to a vertebral position is shown. [Figure 9A] Another embodiment of a guidance tool method and system for delivering pedicle screws is shown. [Figure 9B] Another embodiment of a guidance tool method and system for delivering pedicle screws is shown. [Figure 9C] Another embodiment of a guidance tool method and system for delivering pedicle screws is shown. [Figure 9D] Another embodiment of a guidance tool method and system for delivering pedicle screws is shown. [Figure 9E]Another embodiment of a guidance tool method and system for delivering pedicle screws is shown. [Figure 9F] Another embodiment of a guidance tool method and system for delivering pedicle screws is shown. [Figure 9G] Another embodiment of a guidance tool method and system for delivering pedicle screws is shown. [Figure 9H] Another embodiment of a guidance tool method and system for delivering pedicle screws is shown. [Figure 9I] Another embodiment of a guidance tool method and system for delivering pedicle screws is shown. [Figure 9J] Another embodiment of a guidance tool method and system for delivering pedicle screws is shown. [Figure 9K] Another embodiment of a guidance tool method and system for delivering pedicle screws is shown. [Figure 9L] Another embodiment of a guidance tool method and system for delivering pedicle screws is shown. [Figure 9M] Another embodiment of a guidance tool method and system for delivering pedicle screws is shown. [Figure 9N] Another embodiment of a guidance tool method and system for delivering pedicle screws is shown. [Figure 9O] Another embodiment of a guidance tool method and system for delivering pedicle screws is shown. [Figure 9P] Another embodiment of a guidance tool method and system for delivering pedicle screws is shown. [Figure 10A] Another embodiment of a system for stabilizing the vertebrae of the spine, which includes a spinal screw, is shown. [Figure 10B] Another embodiment of a system for stabilizing the vertebrae of the spine, which includes a spinal screw, is shown. [Figure 10C] Another embodiment of a system for stabilizing the vertebrae of the spine, which includes a spinal screw, is shown. [Figure 10D]Another embodiment of a system for stabilizing the vertebrae of the spine, which includes a spinal screw, is shown. [Figure 10E] Another embodiment of a system for stabilizing the vertebrae of the spine, which includes a spinal screw, is shown. [Figure 10F] Another embodiment of a system for stabilizing the vertebrae of the spine, which includes a spinal screw, is shown. [Figure 10G] Another embodiment of a system for stabilizing the vertebrae of the spine, which includes a spinal screw, is shown. [Figure 11A] Another embodiment of a system for stabilizing the vertebrae of the spine, which includes a spinal screw, is shown. [Figure 11B] Another embodiment of a system for stabilizing the vertebrae of the spine, which includes a spinal screw, is shown. [Figure 11C] Another embodiment of a system for stabilizing the vertebrae of the spine, which includes a spinal screw, is shown. [Figure 11D] Another embodiment of a system for stabilizing the vertebrae of the spine, which includes a spinal screw, is shown. [Figure 11E] Another embodiment of a system for stabilizing the vertebrae of the spine, which includes a spinal screw, is shown. [Figure 11F] Another embodiment of a system for stabilizing the vertebrae of the spine, which includes a spinal screw, is shown. [Figure 11G] Another embodiment of a system for stabilizing the vertebrae of the spine, which includes a spinal screw, is shown. [Figure 12A] Another embodiment of a system for stabilizing the vertebrae of the spine, which includes a spinal screw, is shown. [Figure 12B] Another embodiment of a system for stabilizing the vertebrae of the spine, which includes a spinal screw, is shown. [Figure 12C] Another embodiment of a system for stabilizing the vertebrae of the spine, which includes a spinal screw, is shown. [Figure 12D] Another embodiment of a system for stabilizing the vertebrae of the spine, which includes a spinal screw, is shown. [Modes for carrying out the invention]

[0042] Embodiments of this disclosure relate to medical devices, systems, and methods for bone fixation. Specifically, some embodiments disclosed herein may be configured to stabilize adjacent vertebrae in at least the cervical, thoracic, and lumbosacral spine. In addition, some embodiments may be configured to fix and stabilize vertebrae in the lumbar spine to alleviate axial back pain and radiculopathy. Some embodiments may be configured to improve minimally invasive surgical (MIS) approaches to pedicle screw fixation by reducing the number and size of incisions and the size of medical instruments inserted therein. Furthermore, some embodiments disclosed herein can improve the efficiency of percutaneous lumbar pedicle screw fixation for surgeons while minimizing surgical trauma to patient tissue.

[0043] For example, but not limited to, some embodiments of the systems for stabilizing the vertebrae disclosed herein are intended to improve minimally invasive (and optionally adaptable to use with percutaneous or endoscopic approaches) TLIF and PLIF approaches, and to support ALIF, DLIF®, and XLIF® approaches. The TLIF approach can offer several advantages, including (i) stabilization of both the anterior and posterior portions of the spine through one or more posterior incisions; (ii) the ability to fill larger volumes and more diverse spaces (anterior disc space with spacers, lateral and posterior intervertebral space between screws and rods) with bone graft material, increasing the chances of successful stabilization through bone development and solidification; (iii) the spacers placed in the anterior disc space maintaining the natural intervertebral disc height and reducing pressure on the nerve roots (from osteophytes, thickening, ligaments, etc.); and (iv) improved safety, as the spinal canal is accessed from only one side, which reduces the risk of pinching, stretching, or otherwise disorienting the spinal nerves.

[0044] Embodiments of this disclosure provide systems, devices, and / or methods for performing minimally invasive posterior and / or transforaminal lumbar pedicle screw fixation or stabilization procedures. Hereafter, references to “fixation” implicitly include stabilization that provides a somewhat large range of motion but does not result in complete bone fixation. Similarly, hereafter references to “stabilization” implicitly include fixation. The primary situations in which a surgeon may use the disclosed system may include (i) micro lumbar interbody fusion, MLIF®, or (ii) minimally invasive TLIF procedures with either symptomatic-side mini-open TLIF and contralateral minimally invasive pedicle screw fixation via an incision. Similarly, the system disclosed herein is used bilaterally in a PLIF approach, where decompression and interbody spacer placement are performed bilaterally. Alternatively, the disclosed system is ideal for “backup” (with minimal posterior incision) anterior interbody fusion (ALIF) and lateral interbody fusion (XLIF® and DLIF®). MLIF (trademark) collectively encompasses (i) transforaminal lumbar interbody fusion and stabilization, (ii) posterior lumbar interbody fusion and stabilization, (iii) anterior lumbar interbody fusion and stabilization, (iv) lateral lumbar interbody fusion and stabilization using a minimally invasive "micro" approach with the guidance system described herein, and (v) posterolateral instrumented fusion in which only pedicle screws are placed for posterolateral fusion without the use of interbody spacers or implants. Lateral fusion such as XLIF or DLIF is truly minimally invasive, and the minimal posterior incision to support lateral interbody spacers using pedicle screw fusion is highly complementary. Lateral interbody fusion is becoming more common, and more spine-related companies are offering their own lateral interbody fusion systems. While the specific embodiments described herein concern minimally invasive procedures through a single skin incision, it will be understood that the systems and methods may also be used in open or mini-open procedures through an opening in the patient's skin, as desired by the practicing surgeon.

[0045] The lumbar spine has a lordotic curvature in which the lowest levels, L4, L5, and S1, have a posteriorly concave orientation or alignment, while the higher levels, L1–L3, have less lordosis. This curvature sets up a unique situation where the trajectories (trajectories for inserting pedicle screws) passing through the pedicles from L2 to S1 are not parallel. Rather, the trajectories generally intersect at points around the skin level. This configuration is analogous to the spokes of a wheel, where the spokes (trajectories) intersect at a common central point (hub). Given that many patients have this lumbar lordotic configuration, it is possible to insert pedicle screws through a single incision centered in the middle of the lumbar curvature. However, if multiple screws are present simultaneously, and each screw requires a separate tower (or tube) (as in conventional tower / tube systems), the total cross-sectional area of ​​the towers / tubes prevents a single small incision. The towers / tubes interfere with each other and get in each other's way due to their size. Furthermore, if the towers of the pedicle screws intersect and are not aligned in a straight line, it is difficult to insert the rod into the seat of the pedicle screw through the channel of the tower.

[0046] Alternative methods are needed to minimize the number and size of incisions. Reducing the number and size of incisions minimizes the tissue trauma required to implant pedicle screws for lumbar stabilization or fixation. An ideal system and procedure would make maximum use of the natural curvature of the lumbar spine to provide this reduction. However, the apparatus and method of this application described herein and claimed is not limited to use in the lumbar spine, and may also be found to fix, stabilize, or otherwise treat vertebrae in other areas of the spine, such as the cervical spine, where lordosis is again the typical anatomical alignment.

[0047] The number of spinal cord patients with osteoporosis requiring surgical intervention is increasing. Historically, this complex patient population has experienced complications associated with bone screw fixation, due to the nature of the bone, the type of screw used, and the geometric shape of the projection, along with the method of insertion. These complications include implant failure, screw loosening, and retrieval. Recent studies suggest that novel cortical screws that project anteromedially and laterally have advantages over conventional screws that project anteromedially. Embodiments of this disclosure can be used to guide and implant novel cortical screws to project anteromedially and laterally, taking this research into consideration, in order to overcome many of the problems of conventional screws in osteoporotic patients. Furthermore, embodiments of this disclosure can be used to implant multiple novel cortical screws through a single incision, minimizing trauma to already sensitive osteoporotic patients.

[0048] The final step in pedicle screw fixation may include rod reduction and final tightening. Rod reduction is typically required when there is vertebral misalignment, such as spondylolisthesis. In this case, the misalignment can be realigned by pulling or pushing the pedicle screw fixed to that vertebra relative to other screws on other vertebrae. By adjusting the relative position of the screw heads, the bent rod can preferably be lowered into the screw head, thereby "reducing" the misalignment or spondylolisthesis. In open surgery, the reduction process is usually performed with a rod reduction tool that pushes the rod into the screw head. In MIS systems, extended threads on a tower or extension tab that extends higher than the screw head allow the locking cap to engage with the threads at a higher position, thereby reducing the rod into the screw head by capturing the rod at a position higher or further away than the final seat of the screw head.

[0049] After the rod is realigned and the vertebrae are aligned, the rod can be locked into the screw head by a locking cap. The locking cap is typically tightened to the final torque using a reverse torque tool. The reverse torque tool is typically a sleeve that passes over the screw head and the blade or tower (if present). The reverse torque tool may have a groove that fits into the screw head and often the rod to provide a reaction force when the locking cap is finally tightened. The reverse torque tool can stabilize the screw head so that rotation of the screw head is minimized during final tightening.

[0050] It is also common to provide compression to the screw heads during the final tightening process. Compression during final locking is considered beneficial to the fixation process because any interbody fusion is thought to be more successful under pressure or compression. Compression also helps to apply pressure to the interbody spacer, reducing the likelihood of the spacer retracting, reversing, or moving. Compression is also useful in restoring lumbar lordosis. Many interbody spacers, placed anteriorly through ALIF, laterally through XLIF or DLIF, obliquely through OLIF (oblique lateral interbody fusion), or posteriorly through PLIF or TLIF, can all have a lordotic profile. New expandable cages allow for even greater lordosis. Compression during final tightening can optimize lordosis through posterior compression during final locking.

[0051] A typical pedicle screw system uses separate tools for screw insertion, screw alignment, rod insertion, cap insertion, rod reduction, reverse torque, and final tightening. All of these separate tools require an extra step at each pedicle screw. Each extra step introduces further stimulation of muscles and tissues, as well as time. Therefore, a system in which pedicle screws pre-mounted in a tower system can perform all of these tasks without additional tools is indeed time-saving and optimal. Some embodiments disclosed herein describe a system of towers that are removably mounted to pedicle screws. In some embodiments, • The tower can cross the path without interference (in situations with lordosis). The tower can be used to align screw heads without requiring a separate tool to straighten the screw heads. • The length and curvature of the rod can be measured using the tower. The tower allows for easy placement and visualization of the rod, even in MIS approaches and in large patients where visualization is difficult. The tower can enable and / or facilitate rod reduction and spondylolisthesis reduction. The tower can enable final tightening under compression or stretching without the need for separate compression or stretching tools. The tower can provide reverse torque during final tightening without a reverse torque tool, and / or The tower attached to the screw can be held in place by the robot, and all aspects of the rod's placement, retraction, compression, and final tightening with reverse torque can be performed by the robot via the mechanical connection between the tower system components and the robotic arm. The robot, navigation system, and software can be configured to always know the position of all towers, screws, rods, and caps.

[0052] Some embodiments of the cross-tower systems disclosed herein can enable or provide an optimal MIS system that minimizes incision size and tissue damage, optimizes the surgical procedure, minimizes the number of tools, and reduces surgical time. Previous MIS tower systems are implanted in an awkward configuration where the screw trajectories intersect due to lumbar lordosis, with the towers angled parallel to each other. In other cases, the MIS tower is implanted through a single incision, with the towers intersecting adjacent to each other, making rod insertion and final tightening extremely difficult and frustrating. Some embodiments of this disclosure can avoid these difficulties and provide an optimized MIS pedicle screw system.

[0053] Some embodiments disclosed herein provide a simple method and associated apparatus for implanting two or more pedicle screws through a single small hole. This provides better cosmetic and functional results using only a single skin incision of small size (approximately 0.5 cm to 4 cm, approximately 0.5 cm to 3 cm, or approximately 1 cm to 2 cm) regardless of the number of screws used. In one embodiment, the single incision is smaller than the sum of the maximum widths of the two largest elements of each screw inserted through the single incision, and the elements include the screw, screw head, rod, locking assembly, and associated tools.

[0054] Some embodiments disclosed herein are configured to allow a surgeon or other user to insert, position, and manipulate spinal implants, such as rods and locking assemblies, through the same small incision in order to lock a rod into a screw. Certain embodiments provide novel methods for inserting a rod into the head of a pedicle screw and for locking a rod into a screw through a single small incision. The systems and methods, in certain embodiments, involve the attachment of guide elements, consisting of one or more flexible wires, flexible but rigid stretch blades, stretch tabs, or towers, attached to the head of each pedicle screw, used to guide the rod downward into the screw. The guide elements are configured and combined so that they can overlap or cross in or beneath the skin incision, thereby enabling the use of a small single skin incision. The screw, rod, and locking assembly are all placed through a single small incision and can still be properly interconnected therein due to the natural lordosis of the lumbar spine. By attaching at least one guidance element to each side of the screw head, the guidance elements help align the screw head. The guidance elements also trap or limit the displacement of the rods, fitting the rods between them and directly into the screw head.

[0055] Compared to Sicvol's U.S. Patent No. 7,179,261 described above, embodiments of the present disclosure eliminate the need for “notches” where guide elements intersect. For example, in embodiments utilizing stretch tabs or stretch blades, these stretch tabs or stretch blades have no proximal, distal, or arbitrary lumen, and the configuration of the guidance elements (stretch tabs or stretch blades) for the screw at adjacent levels allows the tabs to fully intersect and overlap for any patient with any relative geometric shape. Thus, interference between adjacent guidance elements on adjacent vertebrae is not an issue. Also, in the notched tube taught by Patent No. 261, a rod or other element still has to be inserted through the tube at some point. The notched tube requires that the rod (or other inserted element) be oriented parallel to the longitudinal axis of the tube when directed into the body until it reaches a section having a side wall opening or slot distal to the notched section, at which point the rod may, if desired, be reoriented perpendicular to the longitudinal axis and directed to exit the side wall through the opening or slot. In embodiments of the present disclosure, by using guidance elements such as extension blades or extension tabs (from the screw head), elements (e.g., rods, locking assemblies, etc.) guided by and inserted along them do not need to be inserted through any lumen. When the rod is inserted using the blades, the blades can be easily supplied through the outer edge of the rod body, through retaining elements or fasteners attached to the rod body, or between the outer edge of the rod body and the retaining elements (retaining threads). Thus, the inserted rod or other element can be oriented perpendicular to the longitudinal axis or at any other method or angle throughout the entire entry path. This provides greater flexibility to avoid interference between adjacent stabilization system components and eliminates the need for surgeons to identify notched sections before rotating screws / rods vertically and / or reorienting them.Furthermore, because there are no proximal or distal lumens with extension tabs, blades from adjacent levels can overlap and cross without the need for notches, thus allowing all blades to exit through a single, small, minimal incision.

[0056] The guidance element can also be used to guide the locking assembly downward to the screw head in embodiments where the locking assembly is not part of the screw head itself (and has already fallen down to it).

[0057] Another embodiment is a hybrid system in which each screw is placed through a short tower or tube that does not reach the skin surface. The wire, blade, or tab extension is attached to the top of the tower or tube, and as a result, the screws, rods, locking assemblies, and tools used for insertion, adjustment, locking, compression, stretching, and removal are guided by the extension close to the skin, but through the individual tower or tube close to the bone and pedicle screws. This hybrid system offers both the advantage of the wire / stretching blade / tab system, where many guidance elements can overlap at the skin level in a single incision, and the advantage of the tower or tube system, where the advantages are retained at the bone level. Some surgeons who prefer the tower system but desire the advantages of the blade / tab system may prefer to use this hybrid system.

[0058] By making some of the guidance elements retractable, more guidance elements can be smoothly fitted through a single incision, thereby advantageously reducing the need for larger incisions and / or multiple incisions. After insertion, the various guidance elements may be retractably extended as needed. By using retractable components as part of an upwardly oriented extension guidance element, a rod for stabilizing the vertebra can be inserted into the body through the retractable component and through the same single incision, minimizing the invasiveness of the procedure.

[0059] All combinations and arrangements of towers, tubes, blades, arms, tabs, wires, and other upward-extending guidance elements are intended to be within the spirit and scope of this disclosure, either as described herein or in hybrid systems combining conventional tower / guidance elements as described in the prior art (as described in the references incorporated by reference throughout this specification). As used herein, the terms guiding element or induction element are intended to include one or more components extending between a screw and a skin incision, preferably directly or indirectly coupled or detachably connected to the screw head, and include both conventional towers or tubes, such as those made from rigid or semi-rigid materials as described in the patents and publications incorporated by reference throughout this specification, as well as additional embodiments of guiding elements as described herein. The most appropriate selection and arrangement is to be determined by the surgeon in each particular case. For example, in one embodiment, a telescopic tube may be at one level, a wire at the next level, and a blade at the next level on one side (of the slot for the rod), with the blade attached to the wire on the other side (of the slot for the rod). To introduce more components through the same incision, different deformation morphologies may be selected for each side (medial and lateral). The goal is to minimize the number of incisions and prevent overcrowding while providing sufficient guidance elements to properly guide stabilization rods, locking assemblies, tools, etc., into the pedicle. Eliminating overcrowding allows for proper visualization, enabling the surgeon to work comfortably and efficiently.

[0060] In some embodiments, a system is provided for performing spinal stabilization through an opening in the patient's skin. In some embodiments, the opening may be a single minimally invasive skin incision. The system comprises a first screw having a screw head and a first guide element (also referred to herein as a first extension) having a height component detachably connected to the first screw, wherein the first screw is configured to be embedded in a first vertebra. The system also comprises a second screw having a screw head and a second guide element detachably connected to the second screw, wherein the second screw is configured to be embedded in a second vertebra. The first screw having the first guide element and the second screw having the second guide element may be delivered into the first and second vertebrae.

[0061] Other purposes and benefits of embodiments of this disclosure are described below. Implicit modifications of this disclosure based on the explicit descriptions are at least partially apparent from the descriptions or can be learned through the implementation of this disclosure. Such subtle and predictable modifications and adaptations are deemed to be within the scope of this disclosure. Further benefits of this disclosure can be realized and obtained by means and combinations specifically noted below.

[0062] Embodiments disclosed herein include improved systems, devices, and methods for guiding one or more screws, rods, and locking assemblies downward to a vertebra and fixing the rod or other spinal implant to stabilize the vertebra. Embodiments of devices or systems for stabilizing a spinal vertebra are disclosed herein as shown in Figures 1A to 1Z, the features of which may be utilized in conjunction with all other embodiments described herein. In some embodiments, the system for stabilizing a spinal vertebra may include a pedicle screw. In some embodiments, the screw 110 (shown as 110A in part of the figures) may include a bone engagement shaft 112 and a screw head 114. In some examples, the bone engagement shaft 112 is threaded. The bone engagement shaft 112 may be movable relative to the screw head 114 at different angles. In some embodiments, the screw head 114 generally has a U-shape defining an upwardly extending arm that forms a channel for receiving a rod 120. The rod 120 may be seated on the head of the bone engagement shaft 112, or it may be seated on an insert 116 that is placed in the screw head 114 to receive the rod 120.

[0063] The locking assembly may be incorporated into or mounted on the screw head, or it may be a separate element. A separate locking assembly may include (but not limited to) those that rely on a cap and a set screw. A locking assembly integrated with the screw head may include (but not limited to) a rotatable mechanism in which the rotation of the screw head captures the rod. Depending on the details of the locking mechanism used to secure the rod, the locking assembly may be guided downward to the screw before or after the insertion of the rod. In some embodiments, the locking assembly is already present on the screw head before the rod is received. In some examples, the rod is first inserted into the screw head 114, followed by the insertion of the locking assembly. In some embodiments, an upwardly extending arm of the screw head 114 may be internally threaded to receive an externally threaded cap screw that is rotated into the screw head 114 to apply a downward force to the rod 120 seated in a channel of the screw head 114. This downward force can also then lock the position of the screw head 114 relative to the rod 120.

[0064] Guidance elements for orienting the rod 120, various locking assembly components (e.g., screw head caps), surgical insertion and manipulation tools, and other components into position may be any type of upward-oriented extension guidance element. These guidance elements are preferably removably connected to the screw head or screw so that they can be easily removed once the procedure is complete. Suitable guidance elements include tubes, towers, blades, arms, extension tabs, wires, strings, and the like. In some embodiments, the extension tab or extension blade of the guidance element extends upward from a portion adjacent to the screw head through the incision site. In some examples, the guidance element may be curved or bent (along one or more axes) to accommodate the cap and other components. Guidance elements may also be curved or bent so as to be offset from adjacent elements so as not to interfere when they intersect. The curves may be permanently rounded shapes, or they may be flexibly bendable or consist of foldable panels. The curvature and bending may be permanent and pre-formed or adjustable in situ. The extension guidance elements may also be tapered, threaded, and / or notched to help stabilize the cap or other components as they descend to the screw head.

[0065] In some embodiments, the guidance element comprises two or more blades that can be offset from one another. In some examples, the offset configuration of two or more blades allows the two or more blades to intersect without interfering with each other. In some embodiments, the multiple blades 132 of each guidance element 130 of the screw 110 can be configured to intersect and / or overlap as described above. In some examples, the guidance elements can be offset in any functional way, such as at different positions around the screw head (e.g., for staggered intersections), curves at different positions (e.g., from straight to bend), curves that do not intersect with adjacent elements (blades from adjacent screw heads), etc.

[0066] Expansion tabs / extension blades or other guidance elements on adjacent threads may be offset so as not to interfere with each other when they intersect. Rather, when they intersect, the expansion tabs / extension blades (or other guidance elements) may be configured to pass smoothly through each other. Thus, expansion tabs / extension blades on adjacent threads can be inserted through the same small incision and manipulated within that incision. This can be achieved by tabs / blades or other guidance elements on the inside of one thread and on the outside of the other thread. In some embodiments, the tabs / blades for adjacent threads may simply be staggered or not aligned at all. In some examples, one thread may have a single tab / blade on the inside, and another thread may have a single tab / blade on the outside. In some embodiments, one thread may have an expansion tab, while one or more of the other threads may have a flexible wire as a guidance element.

[0067] In some embodiments, some of the stretching guidance elements (tabs, blades, etc.) on some screw heads may be straight, while others are flexible or angled, so that the flexible or angled elements intersect the straight elements and exit the body through the same skin-level incision. In other embodiments, a first screw is connected to a first stretching guidance element in the form of multiple blades, and a second screw is connected to a second stretching guidance element in the form of multiple blades. The multiple blades of the first stretching guidance element may overlap and / or intersect with the multiple blades of the second stretching guidance element. Advantageously, the first and second stretching guidance elements may intersect or overlap at or near the skin-level incision. By intersecting or overlapping at or near the skin-level incision, this allows both guidance elements to extend through a single small incision.

[0068] The extension tab / extension blade or other guidance element is configured to be easily removed from the screw head once the rod, cap, tool, and other components have been precisely oriented to the screw head. This removal process may be carried out by any number of means, including breaking along a pre-drilled or notched line, burning or melting at the base of the tab / blade using a tool, or releasing a mechanical clamp. In some embodiments, extension guidance elements for adjacent screws (e.g., extension tab, extension blade, etc.) may be mounted on their respective screw heads at different positions along the screw head to create an offset configuration. In some examples, the extension guidance elements may be mounted on their respective screw heads at the same position and bent at different angles to form different configurations that are offset from each other when they intersect. For example, the extension guidance elements may be bent to exit the screw head with different lateral displacements so that they do not interfere with each other. In some embodiments, three offset extension guidance elements (tabs, blades, etc.) mounted on three adjacent screws can be used for two levels of fastening. In some examples, four offset extension guidance elements mounted on four adjacent screws can be used for three levels of fastening. In some embodiments, five offset stretching guidance elements mounted on five adjacent screws can be used for four levels of fixation. In four levels of fixation, potentially, all five offset stretching guidance elements may be configured to intersect at or near the same level skin incision, through the same level skin incision.

[0069] In some embodiments, the stretching tabs / stretching blades / arms and wires can function together in a "hybrid" concept. For example, a first tab / blade / arm can be attached to a screw head and configured to be easily removable. Additional tabs / blades / arms between the screw head and the distal wire protruding from the skin may be added and / or removed as needed to extend or shorten the distance of the guidance trajectory. In some embodiments, the guidance element may include a number of breaking tabs / blades / arms mounted in series with each other to form a long, stretched blade. The blade can then be adjusted to the appropriate length, such as at the level of a skin incision, by breaking the tabs at the breaking point closest to the desired length. In some embodiments, one or more of the breaking tabs can be attached to a proximal wire to track and locate the tabs within the patient.

[0070] In some embodiments, flexible guide wires may be used to orient other guidance element features (e.g., tabs, blades, arms) during insertion and removal. The guide wire can function as a guide to orient add-on tab elements to a predetermined position within the patient. In some examples, multiple flexible guide wires can act alone as guidance elements to guide a rod, tool, or locking assembly component to a desired location in or near the spine. In some embodiments, flexible guide wires can be part of a “hybrid” concept, working in conjunction with tabs / blades / arms to guide the element to a desired location. The rod, tool, or locking assembly component can be delivered by hand, or in some embodiments, using a stereotactic guidance mechanism and / or by robot, via the guidance element.

[0071] Additional embodiments of systems and methods for stabilizing pedicle screws of vertebral vertebrae are also disclosed in U.S. Patent No. 8,721,691, the entire contents of which are incorporated herein by reference.

[0072] As used herein, distal is defined as the space further away from a particular location, and proximal is defined as the space closer to a particular location. In some embodiments, a portion of the tab or blade extending beyond the incision can be considered the proximal portion, while a portion of the tab or blade below the incision can be considered the distal portion.

[0073] The systems, devices, and methods shown in Figures 1A to 1Z. Figures 1A to 1Z illustrate a method for embedding multiple screws into multiple vertebrae, as well as an embodiment of the embedding and fixing of the rods. The method disclosed in Figures 1A to 1Z includes the screws 110a and 110b described above. Although the illustrated method includes only two screws, the disclosed method can be used for any number of screws embedded in any number of vertebrae in any order.

[0074] Figure 1A shows a first guide wire 160a and a second guide wire 160b positioned at target locations on the first and second vertebrae. As shown, the first guide wire 160a is directed to a vertebra lower than the vertebra to which the second guide wire 160b is directed. Each of the first and second guide wires 160a and 160b is configured to direct the first screw 110a and the second screw 110b to their respective vertebrae. As shown in Figure 1B, the first screw 110a is directed downwards from the first guide wire 160a. As described above, the first screw 110a includes a bone engagement shaft 112a, a screw head 114a, and a plurality of wires 140a, 140b, where at least one of the plurality of wires 140a is located on either side of the screw head 114a.

[0075] As shown in Figure 1D, once the screw 110a is guided to the target position on the first vertebra, the bone engagement shaft 112a is screwed into and held within the first vertebra. As shown in Figure 1E, once the screw 110a is fixed, the guidewire 160a is withdrawn from the body.

[0076] Figure 1E shows a perspective view of the first screw 110a that has been implanted. As shown, the wire 140a is attached to the screw head 114a at its distal end, such that the proximal end of the wire 140a extends outward from the incision 150. In preparation for the implantation of the second screw 110b, the multiple wires 140a are bent away from each other to increase access to the incision (see Figure 1F).

[0077] Similar to the implantation of the first screw 110a, the second screw 110b can be guided into the second vertebra by a second guidewire 160b. In some embodiments, as shown in Figure 1G, the second screw 110b can be inserted with the distal end 139 of the tower 130 held around the proximal end of the screw head 114b. As will be more clearly visible in later figures, the tower 130 is arranged around a plurality of wires 140b. In some examples, as shown in Figure 1H, the proximal ends of the wires 140b extend from the proximal end 138 of the tower 130.

[0078] Figure 1I shows a perspective view of the tower 130 with an embedded first screw 110a, an embedded second screw 110b, and wires 140b and the second screw head 114b arranged around the screw head 114b. As shown, the second guide wire 160b has been removed, and the multiple wires 140a remain bent away from each other to allow access to the window 131 of the tower 130.

[0079] Figures 1J to 1L show the insertion and placement of the rod 120 into the first insert 116a of the first screw 110a and the second insert 116b of the second screw 110b. In some embodiments, the rod 120 (or other implant) can be inserted through the incision 150 between the bent wire 140a and the window 131 of the tower 130. In some examples, the first end 121 of the rod 120 passes through the window 131 of the tower 130. The first end 121 can be guided down the window 131 of the tower 130 and the distal end of the wire 140a until it enters the insert 116a of the first screw head 114a in the first vertebra. In some examples, the second end 122 of the rod 120 is guided down the window 131 until it enters the insert 116b of the second screw head 114a in the second vertebra.

[0080] In some embodiments, a locking assembly can be inserted onto the rod 120 to secure the rod 120 within the first thread 110a and the second thread 110b. As described in more detail above, the locking assembly may be incorporated into or attached to the thread head, or it may be a separate element. A separate locking assembly may include (but not limited to) those that rely on a cap and a set screw. Depending on the details of the locking mechanism used to secure the rod, the locking assembly may be guided downward to the thread before or after the insertion of the rod. In some embodiments, the locking assembly is already present on the thread head before the rod is received. In some examples, the rod is first inserted into the thread head 114, followed by the insertion of the locking assembly. In some embodiments, as shown in Figures 1M and 1N, the locking assembly is a thread cap 170 that can cover and retain the rod 120. As shown in Figure 1M, the thread cap 170 can be retained in an opening 133 at the proximal end 138 of the tower 130. The tower 130 is configured to guide the tower 130 into the threaded head 114b of the screw 110b (see Figure 1N). In some embodiments, the upward-extending arm of the threaded head 114b may be female-threaded, and the threaded cap 170 may be male-threaded. To secure the threaded cap 170, the male-threaded threaded cap 170 can be rotated into the threaded head 114b, thereby applying a downward force to the rod 120 seated in the insert 116b of the threaded head 114b. This downward force can also then lock the second end 122 of the rod 120 so that the threaded head 114b is secured to the rod 120.

[0081] In some examples, the tower 130 can be moved from accessing one screw to another. Figures 10–1V show the tower 130 moved from accessing the second screw 110b to accessing the first screw 110a. As shown in Figure 10, the tower 130 can be pulled out proximal such that the distal end 139 of the tower 130 is disengaged from the proximal end of the second screw head 114b. When the tower 130 is pulled out, it is pulled along the length of the wire 140b attached to the proximal end of the screw head 114b (see Figure 1P). Figures 1Q–1S show perspective views of the embedded first screw 110a and second screw 110b. In some embodiments, the wires 140a can be bent so that pairs of wires 140a are closer to each other, in order to allow the tower 130 to be arranged around multiple wires 140a of the first screw 110a (see Figure 1R). In some cases, multiple wires 140b can be bent away from each other to provide additional space and access to the incision 150 (see Figure 1S).

[0082] Figure 1T shows a side view of the embedded first screw 110a and second screw 110b. In some embodiments, when wires 140a and 140b are bent to accommodate the tower 130, the tower 130 can be positioned around wire 140a of screw 110a. As shown in Figures 1U and 1V, the tower 130 can be inserted distally such that the distal end 139 of the tower 130 is positioned around the proximal end of the screw head 114a.

[0083] As described with respect to inserting the screw cap 170 onto the screw head 114a of the screw 110a, the second screw cap 170 can be inserted through the opening 133 of the proximal end 138 of the tower 130. As shown in Figures 1W and 1X, the second screw cap 170 can be guided onto the screw head 114a of the screw 110a. As described above with respect to the first screw cap 170, in some embodiments, the upward-extending arm of the screw head 114a may be female-threaded, and the second screw cap 170 may be male-threaded. To secure the second screw cap 170, the male-threaded screw cap 170 can be rotated into the screw head 114a, applying a downward force to the rod 120 seated within the screw head 114a. This downward force can also then lock the first end 121 of the rod 120 so that the screw head 114a is secured to the rod 120.

[0084] Once the first thread 110a and the second thread 110b are embedded and the rod 120 is secured by the first thread cap 170 and the second thread cap 170, the tower 130 can be removed from the incision 150. In some embodiments, as shown in Figure 1Z, the first pair of wires 140a and the second pair of wires 140b can be removed from the embedded first thread 110a and the second thread 110b. In some examples, the wires 140a and 140b are broken off along with the proximal ends of the thread heads 114a and 114b. As shown in Figure 1Z, in some embodiments, the first thread cap 170 and the second thread cap 170 are adjacent to the proximal ends of the thread heads 114a and 114b.

[0085] The systems, devices, and methods shown in Figures 2A to 2T. Figures 2A to 2T show another embodiment of the method and system 200 for stabilizing vertebrae. Any one or more embodiments of the system disclosed herein may have, in place of or in any combination thereof, any of the components, features, and / or other details disclosed herein with respect to any one or more embodiments of the system disclosed below, including, without limiting any embodiment of the system 200, any of the screws, extensions (also referred to as towers, extension towers, or guide elements), or other components, features, and / or other details of any other embodiment of the implanted system disclosed herein or incorporated herein by reference as if it were fully described herein. In addition, any of the processes, process sequences, or procedures described above with respect to any other system embodiment, or disclosed in U.S. Patent No. 8,721,691, may be used in place of, or in any combination of, any of the processes, process sequences, or procedures described below with respect to any of the system embodiments disclosed below (including, but not limited to, the system 200), to form new processes, process sequences, and procedures for any of the system embodiments disclosed below (including, but not limited to, the system 200).

[0086] Figure 2A shows the first guide wire 202 and the second guide wire 204 (which may be K wires) of the spinal stabilization system 200 advanced through the incision 206 into a target location within the patient's vertebral bone. In any embodiment, as shown, the first and second guide wires can be advanced through a single incision. In other embodiments, three or more guide wires for three or more devices or implants can be advanced through a single incision. Figure 2B shows a first extension 208 having a proximal end portion 208a and a distal end portion 208b, which may be coupled with a first screw 210 that advances on the first guide wire 202 through the incision 206. The screw 210 may be selectively detachable from the extension member 208 at the distal end portion 208b of the extension member 208.

[0087] The following describes some embodiments of a system 200 for stabilizing vertebrae, which can be performed through a single skin incision such as an incision 206. As shown in Figures 2A to 2T, any embodiment of the system 200 may include a first screw 210 having a first screw head 210a, a second screw 230 having a second screw head 230a, a first extension 208 having a body portion 209, and a second extension 228 having a body portion 229. The first extension 208 may be configured to be detachably coupled to the first screw 210 at the first end of the body portion 209 of the first extension 208 by any technique known in the art or disclosed herein, or by using any of the components, and the second extension may be configured to be detachably coupled to the second screw at the first end of the body portion 229 of the second extension 228 by any technique known in the art or disclosed herein, or by using any of the components. The first extension 208 may further include a handle portion 214 (also referred to herein as a handle member) which may be coupled to the proximal end of the body portion of the first extension. The handle portion 214 may extend at an angle away from the proximal end of the body portion of the first extension 208. Note that the terms guide element or extension element may be used to describe the extension components described herein.

[0088] First extension: In any embodiment, the first extension 208 may be shorter than the second extension. For example, the first extension 208 may be sized such that, when the first screw 210 is embedded in the first vertebra 211, the proximal end of the main body portion 209 of the first extension 208 extends to the height just below the patient's skin, or when the first screw 210 is embedded in the vertebra, the proximal end 208a of the first extension 208 extends to the height just below the patient's skin, or to the same height as the patient's skin. Alternatively, the first extension portion 208 may be sized such that when the first screw 210 is embedded in the vertebra, only the proximal end portion 208a of the first extension portion 208 (for example, but not limited to, 10% or about 10% of the total length of the first extension portion 208, or 5% or about 5% to 10% or about 10% of the total length of the first extension portion 208) extends through the skin incision 206, or when the first screw 210 is embedded in the vertebra, no portion of the first extension portion 208 extends through the skin incision. Furthermore, in any embodiment, the first extension portion 208 may be sized such that when the first screw 210 is embedded in the vertebra, the entire body portion 209 of the first extension portion 208 is positionable below the patient's skin surface, with only the handle portion 214 extending through the skin incision.

[0089] For example, but not limited to, a surgeon may measure the distance from the vertebra to the skin surface and select a first extension 208 having an appropriate length that matches or substantially matches the distance from the vertebra to the skin surface. In some embodiments, the first extension 208 may have an adjustable length, such as a telescopic body, which can be adjusted by the surgeon before and / or after the first screw 210 is implanted. In this configuration, the length of the first extension 208 may, but is not limited to, being adjusted so that the total length of the first extension is at or below the patient's skin surface, or substantially (as described above) at or below the patient's skin surface.

[0090] Second extension: In any embodiment, the second extension 228 may be sized to extend completely through the skin incision 206 when the second screw 230 is embedded in the vertebra. In some embodiments, the main body portion 209 of the first extension 208 may have an adjustable length. In some embodiments, each of the first extension 208 and the second extension 228 may have a fixed length. In some embodiments, the first and second main body portions may be molded into a substantially cylindrical shape.

[0091] Handle section: Figure 4 shows a handle portion 214 (also referred to herein as a handle) which may be coupled to or integrally formed with the first extension portion 208. The handle portion 214 may have a proximal portion 214a and a distal portion 214b. In any embodiment, the handle portion 214 may be coupled to the first extension portion 208 at its proximal end portion 208a. The handle portion 214 and the first extension portion 208 may be configured so that a surgeon or other user can rotate, move, torque, bend, or otherwise manipulate the first extension portion 208 when the first extension portion is inside the incision using the handle portion 214, and when the handle portion is positioned outside the body.

[0092] In any embodiment, the handle portion 214 can extend away from the first extension portion 208 at any desired angle. For example, in some embodiments, but not limited to, the handle portion 214 can extend away from the axial centerline of the first extension portion 208 at an angle A (as shown in Figure 2C) which is 45° or about 45° from the axial centerline of the first extension portion 208, or 30° or about 30° to 50° or about 50° from the axial centerline of the first extension portion 208, or 40° or about 40° to 45° or about 45°. Furthermore, in some embodiments, the angle of the handle portion 214 relative to the first extension portion 208 may be variable through a joint attachment or adjustable angle connection between the handle portion 214 and the first extension portion 208. In addition, the handle portion 214 can have any desired length. In some embodiments, the length of the handle portion can be varied so that the user can select a desired length of handle portion from a kit of handle portions of various sizes, or the length of the handle portion can be adjustable. In some embodiments, the length of the handle portion 214 can be the same as or substantially the same as the length of the first extension portion 208, or within 25% of the length of the first extension portion. The handle portion 214 or any other handle portion of any embodiment disclosed herein can optionally have any desired cross-sectional shape, including flat, curved, circular, oval, etc. The handle portion 214 or any other handle portion of any embodiment disclosed herein can optionally have any desired longitudinal shape or curve, including a curve that curves away from the skin, a wavy curve that conforms to the grip of a surgeon's hand, or a curve that connects to the handle portion of a second screw to provide a fulcrum, thereby allowing compression of the screw head when the two handles are squeezed together.

[0093] The device 200 may be configured such that a handle portion 214 attached to the proximal end of the first extension 208 is grasped by the surgeon, enabling the surgeon to manipulate the first extension 208, and thus the first screw 210, and the first vertebra to which the first screw 210 is anchored or coupled, during a surgical procedure. In this configuration, the surgeon can, for example, apply compressive force to an adjacent vertebra, or depressurize an adjacent vertebra, or rotate, torque (including reverse torque force applied to the screw when a set screw is installed to fix a rod between adjacent vertebral screws), bend, or otherwise manipulate the first extension, the first screw 210, and / or the first vertebra. In some embodiments, the handle portion 214 can be used to apply rotational force to the first extension 208 around at least the central axis of the first extension. For example, but not limited to, the handle portion 214 may be configured to be grasped by a surgeon to enable the surgeon to manipulate the first extension, or to enable the surgeon to apply a rotational force to the first extension 208 around the central axis of the first extension.

[0094] The handle portion 214 may be a separate component configured to be detachably coupled to the body portion of the first extension. In some embodiments, the handle portion 214 may be detachably coupled to the body portion of the first extension, and the handle portion 214 may have an end portion that can be received into a notch, groove, or other receptacle formed on the side surface of the body portion of the first extension. For example, the handle portion 214 may be detachable from the extension and inserted into a notch, groove, or receptacle formed on one side of the first extension. In this configuration, the screw may be inserted together with the first extension 208 using an inserter. During insertion, the inserter is retained through the first extension 208 and can be inserted as in a normal tower or extension configuration. However, there may be grooves or slots along the side surface of the inserter that lead to grooves or slots along the wall of the first extension. Therefore, after the screw has been inserted, but with the inserter still attached to the screw and the first extension, the handle portion 214 can slide along the side of the inserter with a corresponding groove or configuration, the groove or configuration receiving the handle portion 214 and allowing the handle portion 214 to slide downward into the grooves and slots in the wall of the first extension. The system may have a locking mechanism or feature for selectively fixing or locking the handle portion 214 in place within the wall of the first extension. In some embodiments, the handle portion 214 may be irremovably coupled to the body portion of the first extension or formed integrally with the body portion of the first extension.

[0095] In any embodiment disclosed herein, the first extension 208 may have a recess or notch 215 formed therein in the middle and / or proximal end of the body portion 209 of the second extension 208, which may be configured to receive therein a portion of the outer surface of the body portion 229 of the second extension 228 in an operable state. The recess 215 may have a shape that substantially complements the shape of the outer surface of the body portion 229 of the second extension 228. For example, in some embodiments in which the body portion 229 of the second extension 228 has a round or circular cross-section, the recess 215 may have a curved profile or cross-section that accommodates the round or circular cross-section of the second extension 228. In some embodiments, the first extension 208 may have a recess 215 formed in at least the middle portion and proximal end 208a of the first extension 208, the recess being configured to receive a portion of the outer surface of the body portion 229 of the second extension 228 in the operable state. The handle portion 214 may extend generally away from the recess so as to be away from the body portion 209 of the first extension 208. In this configuration, the second extension 228 may be positioned closer to the first extension 208 and can be advanced through a smaller incision in the patient's skin. The recess 215 can result in a more compact system during surgical procedures, which can reduce the size of the incision, among other advantages.

[0096] In some embodiments, the first extension 208 may have a recess formed therein at the proximal end of the body portion of the first extension, the recess being configured to receive a portion of the outer surface of the body portion 229 of the second extension 228 in an operable state. The handle portion 214 may be coupled to a first side of the body portion 209 of the first extension 208, and the recess may be formed on a second side of the body portion 209 of the first extension 208, which may be opposite to the first side of the body portion of the first extension. In some embodiments, the handle portion 214 may be attached to the body portion 209 of the first extension 208 adjacent to a recess formed in the body portion of the first extension. In some embodiments, some details of the recess may be similar to the recess in the embodiments shown in Figures 39 to 45 of Japanese Patent No. 8,721,691, and details of such embodiments shown and described therein are incorporated by reference as if they were fully described herein.

[0097] In some embodiments, the system may further include at least one handle portion (similar to the embodiment of the handle portion 214 disclosed herein) coupled to the body portion 229 of the second extension 228, or two handle portions coupled to the body portion 229 of the second extension 228, which may be used in conjunction with the handle portion 214 coupled to the first extension 208.

[0098] Connecting member: Any embodiment disclosed herein may further include, in particular as shown in Figure 2I, a connecting member 216 (also referred to herein as a restraint, retaining member, ring, or ring member, as in relation to the restraint 650 described below) which can be configured to connect the first extension 208 and the second extension 228 together. The connecting member 216 may be rigid and may be formed integrally with or separately from the first extension 208 and may be welded, brazed, or otherwise connected to the first extension. In this configuration, the connecting member 216 can provide a selectable or reversible connection or link between the first extension 208 and the second extension 228. Any embodiment of the connecting member 216 may be configured to improve the control and operation of the second extension 228 relative to the first extension 208, and / or the first extension 208 relative to the second extension 228. For example, but not limited to, using the connecting member 216 and the handle portion 214, a surgeon may apply force to the first extending member 208 relative to the second extending member 228 to move the distal end 208b of the first extending member 208 toward the distal end 228b of the second extending member 228, thereby applying a contractile force to the first and second vertebrae, or apply force to the first extending member 208 relative to the second extending member 228 to spread the distal end 208b of the first extending member 208 away from the distal end 228b of the second extending member 228, thereby applying a tensile force to the first and second vertebrae.

[0099] In some embodiments, the connecting member 216 can, in the operational state, be coupled to and surround all or part of the outer surface of the proximal end 208a of the first extension 208 and the main body portion 229 of the second extension 228. In other embodiments, the connecting member 216 can be coupled to the outer surface of the first extension 208 and extend away from it. Referring to Figure 2I, in some embodiments, the connecting member 216 may have an opening 217 through which it passes, the opening 217 being aligned with a recess 215 formed within the first extension 208, and the first extension 208 being sized and configured to receive the second extension 228 through it, so that the second extension 208 can advance through the opening 217 and the recess 215 as the second extension advances toward the second vertebra of the patient.

[0100] In addition, any embodiment may also have a connecting member 216. In some embodiments, the connecting member 216 may be coupled to or formed integrally with the first extension 208. In any embodiment, the connecting member 216 may be coupled to the first extension 208 at the proximal end portion 208a of the first extension 208. In some embodiments, the connecting member 216 may surround a portion of the first extension 208 and / or a portion of the handle portion 214 adjacent to the proximal end 208a of the first extension 208 and / or the distal portion 214b of the handle portion 214. In other embodiments, the connecting member 216 may extend away from the side of the first extension 208 without surrounding any portion of the first extension 208. In some embodiments, the connecting member 216 may be configured to provide a loose connection between the first extension 208 and the second extension 228.

[0101] Furthermore, in any embodiment, the connecting member 216 may be selectively openable so that a surgeon or other user can easily open the connecting member 216 to advance the second extension 228 through the connecting member 216. For example, but not limited to, the connecting member may have a selectively openable fastener so that the second extension 228 or another extension can be advanced through the opening of the connecting member 216 or otherwise coupled to the connecting member 216. In some embodiments, the connecting member 216 may have a deflectable arm and / or fastener, for example, but not limited to, a carabiner-like one. In other embodiments, the connecting member 216 may include a support, such as a T-shaped support, which can be received in a slot in the second extension 228 (for example, a longitudinal slot extending along all or part of the length of the second extension), providing a selectively removable rigid connection between the first and second extensions.

[0102] Window of an extended member: A first extension 208, a second extension 228, or any other extension of any embodiment of the treatment system 200 or any other treatment system disclosed herein may have at least one window or slot 240 extending through its side. Referring to Figure 2L, at least one slot 240 may be configured to receive a connecting element 244, which can be advanced through the slot 240 of the first and second extensions 208, 228 (and / or any other extension) toward a first screw 210 and a second screw 230, and may extend and be used to operably connect the first screw 210 to the second screw 230.

[0103] Connecting elements: As described above, any system disclosed herein may further include a rigid connecting element 244 which can be coupled to the head 210a of the first screw 210 and the head 230a of the second screw 230. The first extension 208 and the second extension 228 may be configured to operably receive the connecting element 244 within slots or windows 240 of the first and second extensions 208, so that the connecting element 244 can be oriented and advanced along the length of the first and second extensions 208, 228 toward the head 210a of the first screw 210 and the head 230a of the second screw 230. In the operable state, the connecting element 244 may extend between the first screw 210 and the second screw 230 when the first and second screws 210, 230 are embedded in the first and second vertebrae 211, 213, respectively. Further details relating to the connection of the connecting element 244 with the first and / or second screws 210, 230 are described in Japanese Patent No. 8,721,691, and such details are incorporated herein by reference as if they were fully described herein, so that any feature, component, method, or other detail relating to any embodiment disclosed herein can be combined with any feature, component, method, or other detail relating to any embodiment disclosed herein to form additional embodiments, all of which are part of this disclosure. Any embodiment disclosed herein may be configured, as if they were fully described herein, to include any feature, component, method disclosed herein or otherwise disclosed in combination with any detail, component, or method disclosed herein.

[0104] An alternative embodiment relating to the coupling of a connecting element with a first, second, and / or third second screw in any embodiment disclosed herein may be configured as a pendulum mechanism for swinging the connecting element from outside the skin through a separate skin incision. This pendulum mechanism may then be configured to orient the connecting element in a continuous manner from the separate skin incision, through the head of the first screw, then the head of the second screw, and vice versa. This pendulum method for inserting the connecting element has been popularized by Medtronic's Sextant system for MIS fixation, as described above. Any embodiment of the system and / or a method of using the system may be configured for use with a pendulum mechanism and may have any of the features of Medtronic's Sextant system for MIS fixation or a similar system or an improved version thereof.

[0105] In some embodiments, the screw head 210a of the first screw 210 may have a channel, recess, or other feature formed within the screw head 210a of the first screw 210 that is configured to receive the connecting element 244, and the screw head 230a of the second screw 230 may similarly have a channel, recess, or other feature formed within the screw head 230a of the second screw 230 that is configured to receive the connecting element 244. The first and second screw heads 210a, 230a may be configured to selectively fix or lock the connecting element 244 to the first and second screw heads 210a, 230a so that the connecting element 244 remains in a fixed position after implantation. In this configuration, the connecting element 244 can fix the first and second vertebrae in a desired relative position.

[0106] Third extending member: Any embodiment may further include a third screw (not shown) having a screw head, and a third extension configured to be detachably coupled to the third screw. Embodiments disclosed herein may further include a third screw having a screw head, a third extension configured to be detachably coupled to the third screw, and a handle portion 214 coupled to the proximal end of the body portion of the third extension, the handle portion 214 extending at an angle away from the proximal end of the body portion of the third extension. The third extension may have a length substantially equal to that of the first extension. The third extension may have a recess formed at the proximal end of the body portion of the third extension, the recess may be configured to receive a portion of the outer surface of the body portion 229 of the second extension 228 in an operable state. Furthermore, any embodiment of the third extension may also have additional connecting elements coupled to the third extension, the connecting elements being configured to allow a removable connection between the third extension and the first extension 208 and / or the second extension 228.

[0107] Implantation procedure: Any of the embodiments disclosed herein may be implanted using any preferred procedure or process, including, but not limited to, any of the procedures or processes described in relation to any other embodiments disclosed herein, including, but not limited to, any of the embodiments disclosed herein, including any of the embodiments disclosed herein, including any of the embodiments disclosed herein, and such procedures or processes are incorporated herein by reference as if they were fully described herein. For example, any of the embodiments disclosed herein may be installed or implanted through a skin incision, and the method includes any combination of the following procedures or actions, namely, implanting a first screw 210 having a first extension 208 (also referred to as a first guide element) coupled thereto into a first vertebra through an incision, the first extension 208 comprising a body portion that extends only to the level of the skin incision or below the level of the skin incision once the first screw 210 is implanted into the first vertebra. The first extension 208 may have a handle portion 214 that is coupled to the proximal end portion of the first extension 208 and extends away from there. The method may further include embedding a second screw 230, to which a second extension 228 is coupled, into the second vertebra through an incision, and the second extension 228 may have a body portion 229 that extends through the skin incision when the second screw 230 is embedded in the second vertebra. The method may further include manipulating the first extension 208 by grasping the handle portion 214 coupled to the first extension 208, and coupling a rigid connector (such as a connecting element 244) to the first screw 210 and the second screw 230 to roughly fix the position of the first screw 210 relative to the second screw 230. Subsequently, the first and second extensions 208, 228 can be removed from the first and second screws 210, 230 and from the patient's body.

[0108] Some embodiments of this method may further include advancing the second extension 228 through a rigid connecting member that can be positioned adjacent to the skin incision, advancing the second extension 228 through a rigid connecting member (such as a connecting member 216) that can be coupled to a portion of the first extension 208, and / or positioning a rigid connecting member around the first extension 208 adjacent to the distal end portion of the handle portion 214 to which the distal end portion of the handle portion 214 is coupled to the first extension 208. In this configuration, embedding the second screw 230 to which the second extension 228 is coupled into the second vertebra through the incision may include advancing the second screw 230 and the second extension 228 through an opening (such as an opening 217) in the connecting member 216.

[0109] In some embodiments of the methods disclosed herein, the body portion of the first extension 208 may include a recess formed in its proximal end portion, configured to receive a portion of the outer surface of the second extension 228 therein. Furthermore, the first extension 208 and the second extension 228 may each have at least one window extending through their sides. Any of the methods disclosed herein may further include coupling the stabilizing element with the thread head 210a of the first screw 210 and the thread head 230a of the second screw 230.

[0110] Figure 2E shows the first screw 210 embedded in the first vertebra 211. As shown in Figure 2E and described above, the device 200 may be sized and configured so that when the first screw is fully embedded in the first vertebra 211, the first extension 208 is fully positioned within the incision 206, and therefore substantially no portion of the first extension 208 extends outside the incision 206 away from the patient's body. As illustrated, the handle portion 214 can extend away from the incision 206 so that all or substantially all of the handle portion 214 is outside the body during the procedure. The first guidewire 202 can then be removed or retained in its previous position for subsequent steps.

[0111] As shown in Figures 2F-1 and 2F-2, and as described above, the handle portion 214 can be used to apply force to the first extension 208, move the first extension 208, or otherwise manipulate it, thereby moving the first vertebra 211 relative to other vertebrae, or otherwise manipulating it. For example, as shown in Figure 2F-2, the proximal portion 214a of the handle portion 214 can be pushed and / or moved in any direction, including a first direction (represented by A1 in Figure 2F-2) which may be away from the second vertebra 213, and in some embodiments, once all components of the system 200 are embedded, a compressive force is applied to the first vertebra 211 relative to the second vertebra 213, moving the first vertebra 211 closer to the second vertebra 213. In other methods or procedures, the proximal portion 214a of the handle portion 214 can be pushed and / or moved toward the second vertebra 213 to apply an tensile or tensile force to the first vertebra 211 relative to the second vertebra 213 once all components of the system 200 are embedded, thereby moving the first vertebra 211 further away from the second vertebra 213. As shown in Figures 2F-1 and 2F-2, the proximal end portion 214a of the handle portion 214 is moved toward the first vertebra 213 toward the second vertebra 213 toward the first vertebra 213 toward the first vertebra 213 toward the first vertebra 213 toward the first vertebra 213 toward the first vertebra 213 toward the first vertebra 213 toward the first vertebra 213 toward the first vertebra 213.

[0112] Referring to Figures 2G-1 and 2G-2, the second extension 228, which can be detachably coupled to the second screw 230, can then be advanced through the incision 206 on the second guidewire 204. Importantly, the connecting member 216 can be embedded and positioned relative to the second guidewire 204 so that the second guidewire 204 extends through the opening or passage 217 of the connecting member 216. In this arrangement, as the second extension 228 advances along the second guidewire 204 through the incision 206, the second extension 228 advances through the opening or passage 217 of the connecting member 216. The second vertebral screw 230 can then be embedded in the second vertebra 213 as shown in Figures 2H-1 and 2H-2, and the second guidewire can then be removed as shown in Figure 2I or left in place for subsequent steps. Subsequently, the extension, screw, and / or vertebra can be manipulated using the handle portion 214 and the second extension portion 228 for compression, decompression, or otherwise.

[0113] Incision site: In any embodiment disclosed herein, the incision may be approximately the diameter of a 10-cent coin, or approximately 1 / 2 to 1 inch, or approximately 1 / 2 to 3 / 4 inches. The system may be configured such that a first screw 210, a second screw, and a third screw are embedded through the skin incision.

[0114] Another shape of the extended portion: In some embodiments, the first extension 208 may have a first flat body and a second flat body (as in some embodiments disclosed in Japanese Patent No. 8,721,691), and the first flat body may be spaced apart from the second flat body to create a space between the first and second flat bodies.

[0115] Furthermore, referring to Figures 2L to 2T, a rigid connecting element (also referred to as a connecting member or rod) can be advanced through an extended portion (for example, through a window in such a screw, but not limited to) and an incision, and can be fixed to the first and second screws using any known or preferred technique and / or components, such as by using set screws as shown in Figures 2P to 2T. The extended portion can then be removed, as shown in Figure 2T.

[0116] In addition to the hybrid systems described above, additional systems combining any of the guide elements described above are also possible. For example, a system for rod delivery may include a mixture of one blade and one or more wires on a single thread. Another system for rod delivery may include a combination of one tube or tower on a first thread and one or more wires or blades on a second thread. Various combinations of guide elements are possible that can be used through a single incision.

[0117] Certain aspects of the systems, devices, components, and / or methods described above or illustrated with reference to Figures 2A to 2T are also encompassed by the following numbered embodiments. These numbered embodiments are intended to cover systems, devices, components, and / or methods including, but not limited to, the embodiments of Figures 2A to 2T, and therefore these numbered embodiments may encompass other embodiments as described throughout this specification. 1. A system for stabilizing the vertebrae through a skin incision, A first screw having a first screw head, A second screw having a second screw head, A first extension having a main body portion, wherein the main body portion is configured to be detachably coupled to a first screw at the distal end of the main body portion of the first extension portion, A second extension having a main body portion, wherein the main body portion is configured to be detachably coupled to a second screw at the distal end of the main body portion of the second extension portion, A handle portion that is connected to or configured to be connected to the proximal end of the main body portion of the first extension, wherein the handle portion extends at a certain angle away from the proximal end of the main body portion of the first extension, Equipped with, The system is configured such that the handle portion is grasped by the surgeon so that the surgeon can apply a rotational force to the first extension portion around at least the central axis of the first extension portion. 2. The system according to Embodiment 1, wherein the first extension is sized such that when the first screw is embedded in the first vertebra, the proximal end of the main body portion of the first extension extends to a height just below the patient's skin. 3. The system according to Embodiment 1, wherein the first extension is sized such that when the first screw is embedded in the first vertebra, the proximal end of the main body of the first extension extends to a height just below the patient's skin or to the same height level as the patient's skin. 4. The system according to Embodiment 1, wherein the first extension is sized such that when the first screw is embedded in the first vertebra, only the proximal end portion of the main body of the first extension extends through the skin incision. 5. The system according to Embodiment 1, wherein the first extension is sized such that when the first screw is embedded in the first vertebra, no portion of the main body of the first extension extends through the skin incision. 6. The system according to Embodiment 1, wherein the first extension is sized so that when the first screw is embedded in the first vertebra, only the handle portion extends through the skin incision, and the entire main body portion of the first extension can be positioned below the patient's skin surface. 7. The system according to any one of the above embodiments, wherein the second extension is sized to extend completely through the skin incision when the second screw is embedded in the second vertebra. 8. The system according to any one of the above embodiments, wherein the system is configured such that the first and second screws are embedded through the same skin incision. 9. The system according to any one of the embodiments described above, wherein the system is configured such that the first screw, the second screw, and the third screw are embedded through the same skin incision. 10. The system according to any one of the above embodiments, wherein the handle portion is configured to be grasped by a surgeon so that the surgeon can operate the first extension portion. 11. The system according to any one of the above embodiments, wherein the handle portion is configured to be grasped by a surgeon so that the surgeon can apply a rotational force to the first extension around the central axis of the first extension. 12. The system according to any one of the above embodiments, wherein the handle portion is detachably coupled to the main body portion of the first extension. 13. The system according to any one of the above embodiments, wherein the handle portion is removably coupled to the body portion of the first extension, and the handle portion has an end portion that can be received in a notch, groove, or other receptacle formed on the side surface of the body portion of the first extension. 14. The system according to any one of the above embodiments, wherein the handle portion is irremovably coupled to the main body portion of the first extension. 15. The system according to any one of the embodiments described above, wherein the handle portion is integrally formed with the main body portion of the first extension portion. 16. The system according to any one of the above embodiments, wherein the first extension has a recess formed therein at the proximal end of the main body portion of the first extension, and the recess is configured to receive a portion of the outer surface of the main body portion of the second extension in an operable state. 17. The system according to embodiment 16, wherein the recess has a shape that generally complements the shape of the outer surface of the main body portion of the second extension. 18. The first extension has a recess formed therein at the proximal end of the main body portion of the first extension, and the recess is configured to receive a portion of the outer surface of the main body portion of the second extension in an operable state. The handle portion extends generally away from the recess, so as to separate from the main body portion of the first extending portion. The system described in any one of the embodiments described above. 19. The first extension has a recess formed therein at the proximal end of the main body portion of the first extension, and the recess is configured to receive a portion of the outer surface of the main body portion of the second extension in an operable state. The handle portion is connected to the first side of the main body portion of the first extension portion. The recess is formed on the second side surface of the main body portion of the first extension portion, which is opposite to the first side surface of the main body portion of the first extension portion. The system described in any one of the embodiments described above. 20. The system according to any one of the above embodiments, wherein the handle portion is attached to the main body portion of the first extension portion adjacent to a recess formed within the main body portion of the first extension portion. 21. The system according to any one of the above embodiments, wherein the main body portion of the first extension has an adjustable length. 22. The system according to any one of the embodiments described above, wherein each of the first and second extensions has a fixed length. 23. The system according to any one of the embodiments described above, wherein the first and second main body portions are formed into a cylindrical shape. 24. The system according to any one of the above embodiments, wherein the first extension includes a first flat body and a second flat body, the first flat body being spaced apart from the second flat body so as to create a space between the first flat body and the second flat body. 25. The system according to any one of the above embodiments, further comprising a rigid connecting member having an opening therein, wherein the connecting member is configured to surround the proximal ends of the main body portion of the first extension and the main body portion of the second extension in an operable state, and to connect the first and second extensions together. 26. The system according to any one of the above embodiments, further comprising a rigid connecting member having an opening configured therein to surround the main body portion of the first extension and the proximal end of the main body portion of the second extension in an operational state, wherein the connecting member is configured to provide a loose connection between the first extension and the second extension. 27. The system according to embodiment 25 or 26, wherein the connecting member is selectively openable. 28. Rigid connection elements, A first receiving element coupled to the first screw head, The present invention further comprises a second receiving element coupled to the second screw head, The first and second receiving elements are configured to operably receive the connecting element, and in the operable state, when the first and second screws are embedded in the first and second vertebrae, respectively, the connecting element extends between the first and second receiving elements. The system described in any one of the embodiments described above. 29. The system according to any one of the above embodiments, wherein the first screw is configured to be embedded in a first vertebra, and the second screw is configured to be embedded in a second vertebra. 30. The system according to any one of the above embodiments, wherein the first screw with a first extension and the second screw with a second extension are configured to be delivered into the first and second vertebrae, respectively, through a skin incision which is a minimally invasive skin incision. 31. The system according to any one of the above embodiments, comprising at least one handle portion coupled to the main body portion of the second extension. 32. The system according to any one of the above embodiments, comprising at least one handle portion coupled to the main body portion of the second extension. 33. The system according to any one of the above embodiments, further comprising a third screw having a screw head, and a third extension configured to be removably coupled to the third screw. 34. A third screw having a screw head, A third extension configured to be detachably coupled to a third screw, A handle portion connected to the proximal end of the main body portion of the third extension, the handle portion extending at a certain angle away from the proximal end of the main body portion of the third extension, The system according to any one of the embodiments described above, further comprising: 35. The system according to embodiment 34, wherein the third extension has a length substantially the same as the length of the first extension. 36. The system according to embodiment 34 or 35, wherein the third extension has a recess formed at the proximal end of the main body portion of the third extension, and the recess is configured to receive therein a portion of the outer surface of the main body portion of the second extension in an operable state. 37. The system according to any one of the above embodiments, wherein the first extending portion has at least one window extending through the side of the main body portion, the at least one window being configured to receive a connecting element configured to extend between the first screw and the second screw in an operable state. 38. The system according to any one of the embodiments described above, wherein the first extension is shorter than the second extension. 39. The system according to any one of the above embodiments, wherein the second extension has at least one window extending through the side of the main body portion, and the at least one window of the second extension is configured to receive a connecting element configured to extend between the first screw and the second screw in an operable state. 40. A method for performing spinal stabilization through a skin incision, the method being: The method involves implanting a first screw, to which a first guide element is attached, into a first vertebra through an incision, wherein the first guide element comprises a main body portion that extends only to the level of the skin incision or below the level of the skin incision when the first screw is implanted into the first vertebra, and a handle portion that is attached to the proximal end portion of the first guide element and extends away from it either before or after the first screw is implanted into the first vertebra. The method involves implanting a second screw, to which a second guide element is attached, into the second vertebra through an incision, wherein the second guide element includes a main body portion that extends through the skin incision when the second screw is implanted into the second vertebra. To operate the first induction element, the handle portion connected to the first induction element is grasped, In order to roughly fix the position of the first screw relative to the second screw, a rigid connector is connected to the first and second screws, Remove the first and second guide elements from the first and second screws, respectively. Methods that include... 41. The method according to Embodiment 40, further comprising advancing a second guide element through a rigid connecting member positioned adjacent to the skin incision. 42. The method according to Embodiment 40, further comprising advancing a second guide element through a rigid connecting member that also surrounds a portion of the first guide element. 43. The method according to Embodiment 40, further comprising positioning a rigid connecting member around a first guide element adjacent to the distal end of the handle portion, and embedding a second screw to which a second guide element is coupled into a second vertebra through an incision, the method comprising advancing the second screw and the second guide element through an opening in the connecting member. 44. The method according to any one of embodiments 40 to 43, wherein the connecting member is a selectively openable connecting member. 45. The method according to embodiment 44, wherein the connecting member includes a carabiner or is otherwise configured to be selectively detachable. 46. ​​The method according to any one embodiment 40 to 45, wherein the distal portion of the handle extends through the skin incision and connects with the first guide element when the first screw is embedded in the first vertebra. 47. The method according to any one embodiment 40 to 46, wherein the main body portion of the first induction element is provided with a recess formed in its proximal end portion, the recess being configured to receive a portion of the outer surface of the second induction element therein. 48. The method according to any one embodiment 40 to 47, wherein the first guide element has at least one window extending through the side of the first guide element. 49. The method according to embodiment 48, wherein the second guide element has at least one window extending through the side of the second guide element. 50. The method according to any one of embodiments 40 to 49, further comprising coupling a stabilizing element to the heads of the first and second screws, respectively. 51. A guide assembly for use in spinal surgery, An induction element comprising an elongated body portion, wherein the distal end of the elongated body portion is configured to be removably connected to a screw, and the proximal end of the body portion is configured to be positioned at or below the level of the patient's skin, A handle portion attached to or configured to be attached to the proximal end of the main body portion, wherein the handle portion extends from the proximal end of the main body portion at a certain angle, Equipped with, The guide element has a recess formed within it at the proximal end of the main body portion, and the recess is configured to receive a portion of the outer surface of another guide element. The handle portion extends away from the proximal end of the main body and away from the recess. Guide assembly.

[0118] The systems, devices, and methods shown in Figures 3A to 3O. Additional embodiments of the system (e.g., system 300) that can be used to stabilize or treat vertebrae through a skin incision S are disclosed below. In any embodiment disclosed herein, any component, feature, or other detail of system 300 may have any of the components, features, or other details of any other system embodiment disclosed herein, or may be used in any combination with any of the components, features, or details of system 200 or method of use disclosed below, in accordance with any of the steps of any other method embodiment disclosed herein, including, but not limited to, any of the embodiments of system 300 or method of use described herein. Similarly, any component, feature, step, or other detail of any other system or method embodiment disclosed herein may have any of the components, features, steps, or other details of system 300 or method of use disclosed herein, in any combination with any of the components, features, or details of system 200 or method of use disclosed herein.

[0119] Some embodiments of the system 300 for stabilizing the vertebrae through a skin incision S may include a first screw 302 having a first screw head, a second screw 304 having a second screw head, a first extension 310 (also referred to herein as a first tower) having a distal portion 310a and a proximal portion 310b, wherein the first extension 310 is configured to be detachably coupled to the first screw 302 at its distal end, and a second extension 320 (also referred to herein as a second tower) having at least one proximal portion 320b, wherein the second extension 320 is configured to be detachably coupled to the second screw 304 at its distal end. In any embodiment disclosed herein, the extension may be referred to as extension, guide element, tower, or other similar terms.

[0120] In some embodiments, the first extension 310 may have two or more proximal portions 310b that extend away from the distal portion 310a of the first extension 310 at various angles. In some embodiments, the first extension 310 may be detachably coupled to the first screw 302 such that when the first extension 310 is coupled to the first screw 302, the axial centerline C of the distal portion 310a of the first extension 310 is substantially collinear with the axial centerline C of the first screw 302. Furthermore, the second extension 320 may be detachably coupled to the second screw 304 such that when the second extension 320 is coupled to the second screw 304, the axial centerline C of the distal portion 310a of the second extension 320 is substantially collinear with the axial centerline C of the second screw 304. In some embodiments, the first extension 310 may be shorter than the second extension 320, or longer than the second extension 320, or may have approximately the same length as the second extension 320.

[0121] In some embodiments, the angle between the proximal portion 310b and the distal portion 310a may be adjustable, or the angle between the proximal portion 320b and the distal portion 320a may be adjustable. Common mechanisms for adjustability are gears or ratchet mechanisms. In this way, the proximal portions 310b or 320b can be angled away from the centerline of the distal portion of each screw. By adjusting the angle, more space may be available for placing the rod and locking cap. Also, by adjusting the angle, it may be easier for the surgeon to grasp both proximal portions of the tower to compress the two proximal portions of the two screws in order to compress the screw heads when locking the cap onto the rod connecting the screw heads. In another embodiment, the proximal portions 310b and 320b may be detachable from the distal portions 310a and 320a. In this way, the proximal portions having different angles with respect to the centerline of the respective distal portions can be switched as needed and reattached to the distal portions of the extension.

[0122] Any embodiment of the system 300 disclosed herein may be configured such that the first screw 302 and the second screw 304 are embedded through the same skin incision S. In addition, any embodiment of the system 300 may be configured such that the first screw 302, the second screw 304, and the third screw are embedded through the same skin incision S.

[0123] In some embodiments, the proximal portion 310b of the first extension 310 may extend at an angle away from the axial centerline C of the distal portion 310a of the first extension 310, such that the proximal portion 310b of the first extension 310 is not substantially collinear with the distal portion 310a of the first extension 310. Furthermore, in the operable state, the proximal portion 310b of the first extension 310 may also be configured to extend at an angle away from the axial centerline C of the distal portion of the second extension 320, such that the proximal portion 310b of the first extension 310 forms an acute angle A with respect to the distal portion of the second extension 320, as shown in Figure 3A. In some embodiments, angle A may be 50° (or about 50°), or 40° (or about 40°) or less to 70° (or about 70°) or more.

[0124] In some embodiments, the first extension 310 may be sized and configured such that, in the operational state, the proximal portion 310b of the first extension 310 can extend away from the skin incision S toward the surgeon. In some embodiments, the distal portion 310a of the first extension 310 may extend away from the first screw 302 to a height just below the skin incision S or to the same height as the patient's skin when the first screw 302 is fully embedded in the first vertebra. Furthermore, the proximal portion 310b of the first extension 310 may be configured to be grasped by a surgeon so that the surgeon can apply rotational force and / or torque force to the first extension 310 about at least the axial centerline C of the distal portion 310a of the first extension 310, so as to rotate the first extension 310 about an axis perpendicular to the axial centerline C of the distal portion 310a of the first extension 310. In some embodiments, the first extension 310 may be sized such that only the proximal portion 310b of the first extension 310 is outside the skin incision S when the first screw 302 is embedded in the first vertebra. In any embodiment, the second extension 320 may be sized to extend completely through the skin incision S when the second screw 304 is embedded in the second vertebra.

[0125] The proximal portion 310b of the first extension 310 may have a length substantially equal to the length of the distal portion 310a of the first extension 310, or a length of at least 80% or less of the length of the distal portion 310a of the first extension 310. In some embodiments, the proximal portion 310b of the first extension 310 may be detachably coupled to the distal portion 310a of the first extension 310. In other embodiments, the proximal portion 310b of the first extension 310 may be non-detachably coupled to the distal portion 310a of the first extension 310. For example, but not limited to, the proximal portion 310b of the first extension 310 may be formed integrally with the main body portion of the first extension 310. In some embodiments, the proximal portion of the first extension 310b or the second extension 320b can be coupled to the distal portion of the respective first extension 310a or the second extension 320b through an adjustable coupling that allows for an adjustable angle between the proximal or distal portions of the respective extensions. An example of such coupling is a hinge.

[0126] Referring to Figures 3A and 3B, at least the distal portion 310a, the proximal portion 310b, and / or the second extension 320 of the first extension 310 may have a tubular or semi-tubular shape. In addition, the first extension 310 may have a notch 324 formed through the wall portion 326 of the first extension 310, and the notch 324 is configured to receive a portion of the outer surface 320a of the second extension 320 in an operable state, for example, as shown in Figure 3A. In some embodiments, the notch 324 may extend through at least the proximal end 310c of the distal portion 310a of the first extension 310. The notch 324 can extend completely through the first extension 310 so that, in the operational state, the second extension 320 and the screw coupled to the extension 320 can completely pass through the notch 324.

[0127] In some embodiments, the notch 324 can extend completely through the first extension 310 so that the second extension 320 can pass through the notch 324 completely in an operable state, and so that the wall portion 326 of the first extension 310 completely and continuously surrounds a portion of the outer surface 320a of the second extension 320. Furthermore, in some embodiments of the notch 324, the distal edge 330 of the notch 324 can be molded to contact the outer surface 320a of the second extension 320 in an operable state, so that the second extension 320 can be rotated about the distal edge 330 of the notch 324 relative to the first extension 310. In some embodiments of the notch 324, it can have an oval shape.

[0128] Referring to Figures 3B to 3D, the notch 324 may have a notch 334 at its proximal end 324a, and the notch 334 of the notch 324 is configured to allow at least a portion of the connecting element 350 to pass through the notch 334 during the deployment of the connecting element 350. In some embodiments, the notch 324 may have a notch 334 at its proximal end, and the notch 334 of the notch 324 is configured to allow at least a portion of the connecting element 350 and a portion of the connecting element embedding device 370 to pass through the notch 334. The width of the notch 334 may be less than the width of the outer surface 320a of the second extending portion 320 so as to prevent the outer surface 320a of the second extending portion 320 from extending into the notch 334. The width of the notch 334 can be less than the width of the notch 324, such that the notch 324 defines a proximal edge 332 that contacts the outer surface 320a of the second extension 320, so that the second extension 320 can rotate relative to the first extension 310 about its proximal edge when at least the proximal portion 310b of the first extension 310 is moved toward the proximal portion 320b of the second extension 320. In some embodiments, the notch 324 can be adjacent to the proximal end of the distal portion 310a of the first extension 310 and the distal end of the proximal portion 310b of the first extension 310. Furthermore, some embodiments of the first extension 310 may have a distal notch 334 formed at the distal end of the first extension 310, the distal notch 334 being configured to allow at least a portion of the connecting element 350 to pass through the distal notch 354 and enter the screw head.

[0129] In some embodiments, at least the distal portion 310a of the first extension 310 may have an adjustable length. Furthermore, some embodiments of the first extension 310 and the second extension 320 may be molded into a cylindrical shape. Other embodiments may have any other desired cross-sectional shape, including a substantially square shape, a triangular cross-sectional shape, an oval cross-sectional shape, a polygonal cross-sectional shape, or any combination thereof. The proximal portion 310b of the first extension 310 may have a cross-sectional profile that has a curved shape, as shown in the figure. Furthermore, the proximal portion 310b of the first extension 310 may have a cross-sectional profile that has a semicircular tubular shape. In some embodiments, the proximal portion 310b of the first extension 310 may have a cross-sectional profile that is substantially the same as half of the distal portion 310a of the first extension 310. In some embodiments, the proximal portion 310b of the first extension 310 may have a planar shape.

[0130] As described above, any embodiment of the system 300 disclosed herein may include a rigid connecting element 350 (which can be embedded using any desired shape and configuration of a connecting element embedding device, such as the embodiment of the connecting element embedding device shown in Figures 3E to 3F), a first receiving element coupled to the head of a first screw 302, and a second receiving element coupled to the head of a second screw 304. Referring to Figures 3L to 3M, the first and second receiving elements may be configured to operably receive the connecting element 350, and the connecting element 350 may extend between the first and second receiving elements when the first screw 302 and the second screw 304 are embedded in the first and second vertebrae, respectively. The first screw 302 may be configured to be embedded in the first vertebra, and the second screw 304 may be configured to be embedded in the second vertebra.

[0131] In some embodiments, the first extension 310 may have at least one window or slot 358 extending through the side of its body portion, the at least one slot 358 being configured to receive a connecting element 350 or to allow the connecting element 350 to pass through it, the connecting element 350 being configured to extend between the first screw 302 and the second screw 304 in an operable state. Furthermore, the second extension 320 may have at least one slot or window 360 extending through the side of its body portion, the at least one slot 360 of the second extension 320 being configured to receive a connecting element 350 being configured to extend between the first screw 302 and the second screw 304 in an operable state.

[0132] Some embodiments of a method for treating a spinal defect include: embedding a first screw 302, which is coupled to a first extension 310, into a first vertebra through an incision; advancing a second extension 320, which is coupled to a second screw 304, through a notch 324 formed in the first extension 310, thereby embedding the second screw 304 into a second vertebra; and moving the proximal end of the proximal portion 310b of the first extension 310 toward the proximal end of the second extension 320, thereby bringing the outer surface 320a of the second extension 320 into contact with at least the proximal edge 332 or the distal edge 351 (shown in Figure 3A) of the surface of the notch 324 or the rest of the surface of the notch 324. In some embodiments, the proximal end of the proximal portion 310b of the first extension 310 is further moved toward the proximal end of the second extension 320, causing the outer surface 320a of the second extension 320 to rotate about at least the distal edge 330 of the notch 324, thereby moving the distal end of the first extension 310 toward the distal end of the second extension 320, and thereby moving the first vertebra toward the second vertebra. In some embodiments, the method may further include coupling a rigid connector 350 with the first screw 302 and the second screw 304 to roughly fix the position of the first screw 302 relative to the second screw 304.

[0133] Referring to Figures 3E to 3G, one embodiment of the connecting element insertion device 370 is shown. In any embodiment disclosed herein, the connecting element insertion device 370 may have a handle 371, a main stem or arm 372 coupled to the handle 371, and a head portion 374 coupled to the main stem 372. In some embodiments, the main stem may have a flexible joint 378 in its middle portion. Referring to Figures 3E and 3F, the joint 378 may be configured to bend or flex so that the distal portion of the stem 372 can rotate relative to the proximal portion of the main stem 372. In some embodiments, the joint 378 may allow the connecting element 350 to rotate. The joint 378 may be a separate flexible joint or element (such as a component containing plastic, rubber, and / or nitinol) added to the shaft 372, or may be formed by other means such as a flexible notch in the tube of the shaft 372. The flexibility of the joint 378 allows the tip of the connecting element 350 to enter substantially perpendicularly into the axis of the first extension with a solid wall. The tip of the connecting element 150 can then slide down the wall toward the threaded head toward the passage 354, as shown in Figures 3H to 3L.

[0134] In some embodiments, the connecting element insertion device 370 can be shorter than conventional rod inserters or devices for inserting connecting elements. The connecting element insertion device 370 can be shorter so that the main stem 372 of the connecting element insertion device 370 can pass through a standard extension or tower. Conventional rod inserters are too long to pass through a standard extension or tower. To do this, the connecting member 380 at the top of the main shaft 372 to which the element insertion device 370 is connected can have two, three, or more holes or connecting interfaces to which a handle such as a handle 371 can be connected. Each of the holes may be configured to allow the handle to extend away from the connecting member 380 in different orientations.

[0135] In some embodiments, a central hole through which the center of the shaft 372 of the connecting element insertion device 370 can pass downward may be for a screwdriver that can tighten or loosen the screws that secure the connecting element 350 (also referred to herein as a rod) within the head portion 374 of the connecting element insertion device 370. The other two holes may be screw holes for handles such as a handle 371 that can be attached to the connecting member 380 from the front and / or rear. The front handle 371 can be inserted first and used to lower the connecting element 350 into the extension or tower as the connecting element 350 passes downward from its vertical orientation to the head of the first screw. Once the connecting element 350 begins to rotate horizontally within the seats of both screw heads, the main shaft 372 of the connecting element insertion device 370 can rotate through the extension or tower and end up on the other side of the extension or tower. On the other side, the last handle can be inserted into the screw hole, thereby allowing the connection element insertion device 370 to be held and stabilized on the other side of the extension or tower. Finally, although not required in some embodiments, the main shaft 372 of the connection element insertion device 370 shaft can be flexible. This flexibility can be either hinged or pliable, as shown here as a notch in the wall of the shaft 372. Any preferred method or material can be used to make the shaft 372 flexible, including but not limited to using flexible materials such as plastic, rubber, or metal such as Nitinol.

[0136] Referring to Figure 3J, this figure shows a connecting element 350 inserted into the seat of both screw heads. The connecting element 350 transitions from a vertical orientation to a horizontal orientation. The flexible portion 378 of the shaft 372 can be bent as shown in Figure 3J. One useful way to insert the connecting element 350 is to keep the tip of the connecting element 350 in contact with the midline wall of the first extension or tower. By keeping the tip of the connecting element 350 in contact with the wall, the surgeon can recognize the position of the connecting element 350 until it hits the bottom of the tower and enters the seat of the screw head. The insertion device 370 can then be rotated to the other side of the extension or tower to seat the connecting element 350 into the head of both screws. The insertion device 370 can then be moved to the other side of the extension or tower so that a cap (such as a cap 390) can be retained through the extension or tower and the connecting element 350 can be secured to the screw attached to the screw.

[0137] Some embodiments of the connecting element insertion device 370 may have a second characteristic. The connecting element insertion device 370 can be short enough to pass under the top of a second screw that holds together two “blades” or sides of the tower or extension. The second handle 371 can be screwed into the connecting member 380 from the other side of the extension (as shown in Figure 3K) after the connecting element insertion device 370 has passed between the blades of the extension or through the slots of the extension. At this point, the first handle 371 of the rod holder can be removed. In any embodiment, as described, the handle 371 of the insertion device 370 can be moved from one side of the extension or tower to the other. Alternatively, in some embodiments, the second screw can be opened at the top (distal end), like an open blade. The handle 371 can then easily pass through. The blades can then be locked together by a cap or screw cap. After the connecting element 350 is coupled to a screw or screw head, in any embodiment disclosed herein, a fastener such as an insert screw or cap 390 shown in Figures 3L to 3M may be advanced through the extension and coupled to an insert or seat supporting the connecting element 350.

[0138] Referring to Figure 3L, the insertion device 370 is positioned on the other side of the extension or tower, with the second handle 373 inserted and the first handle 371 removed. The cap 390 can be inserted through the tower and fixed onto an L5 thread which can be connected to the extension or tower. The thread can be finally tightened to a final torque. It is during the final tightening process that the cap 390 can be tightened to a final torque. This final torque tightening requires a reverse torque mechanism for the thread head while the cap is being tightened to a final torque, so that the entire structure does not rotate during final tightening. The inclined proximal portion of the first extension of the first thread 310b serves as a handle for reverse torque. Therefore, the extensions 310 and 302 function as towers for aligning the screw head, for creating a path for inserting the connecting element (rod) 350, for a conduit to lock the insertion of the cap 390, for compressing the screw head when the tightening cap 390 is finally tightened onto the connecting element 350, and for providing reverse torque when the cap 390 is finally tightened. All of these steps typically require separate tools that are inserted and removed at appropriate steps in the process. However, in the present invention, all of these steps are incorporated and performed by the same extensions 310 and 320. In this way, the operation is simplified, shortened, and made more efficient. Finally, the insertion device 370 can be detached from the connecting element 350 by loosening the internal thread that secures the connecting element 350 to the head of the insertion device 370.

[0139] In any embodiment disclosed herein, the system may include a generally inflexible structure (e.g., an extension) attached to screws that pass through and then interact with each other, thereby enabling compression and reduction without the insertion of additional tools into the patient. This saves time and maintains a smaller incision for faster recovery. In addition, in any of the embodiments disclosed herein, components of the system may be configured for use in robotic surgery. Because the extensions are generally rigid, these extensions can be fixed, held, or mounted to a robotic arm that can know the precise position and orientation of the head of each screw. Knowing this information enables robotic insertion of connecting elements into the seat of the screw head.

[0140] In any embodiment disclosed herein, one or more screws may be embedded by other means, and the extension or guide element may be coupled to the screw head or other components coupled to the screw after the screw has been embedded. In any embodiment disclosed herein, the extension, guide element, and / or tower may be used in conjunction with any of the devices or components illustrated and described in relation to Figures 1A to 1Z, including, but not limited to, wires 140a, 140b, screw 110, insertion part 116a, and / or screw head 114. For example, in any embodiment, but not limited to, first and second extensions 310, 320 may pass over either of the wires 140a, 140b and be fixed to the screw 110 or screw head 114 so that the first and second extensions 310, 320 are coupled to the screw 110 or screw head 114 for further treatment as disclosed herein or in another manner.

[0141] Certain aspects of the systems, devices, components, and / or methods described above or illustrated with respect to FIGS. 3A-3O are also encompassed by the following numbered embodiments. These numbered embodiments are considered to be directed to systems, devices, components, and / or methods including, but not limited to, the embodiments of FIGS. 3A-3O, and accordingly, these numbered embodiments may incorporate other embodiments described throughout this specification. 1. A system for stabilizing a spinal vertebra through a skin incision, comprising: a first screw having a first screw head; a second screw having a second screw head; a first extension having a distal portion and a proximal portion, the first extension being configured to be removably coupled to the first screw at the distal end of the first extension; a second extension having at least a proximal portion, the second extension being configured to be removably coupled to the second screw at the distal end of the second extension; wherein the first extension is configured to be removably coupled to the first screw such that when the first extension is coupled to the first screw, the axial centerline of the distal portion of the first extension is substantially collinear with the axial centerline of the first screw; the second extension is configured to be removably coupled to the second screw such that when the second extension is coupled to the second screw, the axial centerline of the distal portion of the second extension is substantially collinear with the axial centerline of the second screw; the proximal portion of the first extension extends at an angle away from the axial centerline of the distal portion of the first extension such that the proximal portion of the first extension is not substantially collinear with the distal portion of the first extension; the proximal portion of the first extension is configured to extend at an angle away from the axial centerline of the proximal portion of the second extension such that in an operative state, the proximal portion of the first extension forms an acute angle with respect to the proximal portion of the second extension. 2. The first extension portion is sized and configured such that, in an operative state, the proximal portion of the first extension portion extends away from the skin incision and toward the surgeon, of the system according to Embodiment 1. 3. The distal portion of the first extension portion extends away from the first screw and to a height directly below the skin incision or to the same height level as the patient's skin when the first screw is fully embedded within the first vertebra, of the system according to Embodiment 1 or 2. 4. The proximal portion of the first extension portion is configured to be gripped by a surgeon such that the surgeon can apply a rotational force and / or a torque force to the first extension portion about an axis that is perpendicular to the axial centerline of the distal portion of the first extension portion so as to rotate the first extension portion about the axis, of the system according to any one of the preceding embodiments. 5. The first extension portion is sized such that only the proximal portion of the first extension portion is outside the skin incision when the first screw is embedded within the first vertebra, of the system according to any one of the preceding embodiments. 6. The second extension portion is sized to extend completely through the skin incision when the second screw is embedded within the second vertebra, of the system according to any one of the preceding embodiments. 7. The system is configured such that the first and second screws are embedded through the same skin incision, of the system according to any one of the preceding embodiments. 8. The system is configured such that the first screw, the second screw, and the third screw are embedded through the same skin incision, of the system according to any one of the preceding embodiments. 9. The proximal portion of the first extension portion has a length that is substantially the same as the length of the distal portion of the first extension portion, of the system according to any one of the preceding embodiments. 10. The proximal portion of the first extension portion has a length that is at least 80% of the length of the distal portion of the first extension portion, of the system according to any one of the preceding embodiments. 11. The system according to any one of the above embodiments, wherein the proximal portion of the first extension is removably coupled to the distal portion of the first extension. 12. The system according to any one of the above embodiments, wherein the proximal portion of the first extension is irremovably coupled to the distal portion of the first extension. 13. The system according to any one of the above embodiments, wherein the proximal portion of the first extension is formed integrally with the main body portion of the first extension. 14. The system according to any one of the embodiments described above, wherein at least the proximal portions of the first extension and the second extension have a tubular shape. 15. The system according to any one of the above embodiments, wherein the first extension has a notch formed through the wall portion of the first extension, and the notch is configured to receive a portion of the outer surface of the second extension in an operational state. 16. The system according to embodiment 15, wherein the notch extends through at least the proximal end of the distal portion of the first extension. 17. The system according to Embodiment 15, wherein the notch extends completely through the first extending portion, and as a result, in the operational state, the second extending portion can completely pass through the notch. 18. The system according to Embodiment 15, wherein the notch extends entirely through the first extending portion, and as a result, in the operational state, the second extending portion can completely pass through the notch, and as a result, the wall portion of the first extending portion surrounds a portion of the outer surface of the second extending portion. 19. The system according to any one of embodiments 15 to 18, wherein the notch is molded such that the distal edge of the notch is in operable contact with the outer surface of the second extension so that the second extension can rotate around the distal edge of the notch relative to the first extension. 20. The system according to any one of embodiments 15 to 19, wherein the notch has an oval shape. 21. The system according to any one of embodiments 15 to 20, wherein the notch has a notch at the proximal end of the notch, and the notch of the notch is configured to allow the passage of at least a portion of the connecting element through the notch. 22. The system according to any one of embodiments 15 to 21, wherein the notch has a notch at its proximal end, and the notch of the notch is configured to allow at least a portion of the connecting element and a portion of the connecting element embedding device to pass through the notch. 23. The system according to Embodiment 22, wherein the width of the notch is smaller than the width of the outer surface of the second extension, and as a result, the outer surface of the second extension is prevented from extending into the notch. 24. The system according to Embodiment 22, wherein the width of the notch is smaller than the width of the cutout, and as a result the cutout defines a proximal edge configured to contact the outer surface of the second extension, and as a result the second extension can rotate about the proximal edge relative to the first extension when at least the proximal end of the first extension moves toward the proximal end of the second extension. 25. The system according to any one of embodiments 15 to 24, wherein the notches are adjacent to the proximal end of the distal portion of the first extension and to the distal end of the proximal portion of the first extension. 26. The system according to any one of the above embodiments, wherein the first extension has a distal notch formed at the distal end of the first extension, and the distal notch is configured to allow the passage of at least a portion of the connecting element through the distal notch. 27. The system according to any one of the above embodiments, wherein at least the distal portion of the first extension has an adjustable length. 28. The system according to any one of the embodiments described above, wherein the first extension and the second extension are formed into a cylindrical shape. 29. The system according to any one of the above embodiments, wherein the proximal portion of the first extension has a curved cross-sectional profile. 30. The system according to any one of the above embodiments, wherein the proximal portion of the first extension has a cross-sectional profile having a semicircular tubular shape. 31. The system according to any one of the embodiments described above, wherein the proximal portion of the first extension has a cross-sectional profile that is substantially the same as half of the distal portion of the first extension. 32. The system according to any one of the above embodiments, wherein the proximal portion of the first extension has a planar shape. 33. Rigid connection elements, A first receiving element coupled to the first screw head, A second receiving element coupled to the second screw head, Furthermore, The first and second receiving elements are configured to operably receive the connecting element, and in the operable state, when the first and second screws are embedded in the first and second vertebrae, respectively, the connecting element extends between the first and second receiving elements. The system described in any one of the embodiments described above. 34. The system according to any one of the above embodiments, wherein the first screw is configured to be embedded in a first vertebra, and the second screw is configured to be embedded in a second vertebra. 35. The system according to any one of the above embodiments, comprising two or more separate proximal portions extending away from the distal portion of the first extending portion. 36. The system according to any one of the above embodiments, wherein the first extending portion has at least one window extending through the side of the main body portion, the at least one window being configured to receive a connecting element configured to extend between the first screw and the second screw in an operable state. 37. The system according to any one of the embodiments described above, wherein the first extension is shorter than the second extension. 38. The system according to any one of the above embodiments, wherein the second extension has at least one window extending through the side of the main body portion, and the at least one window of the second extension is configured to receive a connecting element configured to extend between the first screw and the second screw in an operable state. 39. A method for stabilizing the vertebrae of the spine, The first screw, which is connected to the first extended portion, is embedded in the first vertebra through the incision. The second extension, which is connected to the second screw, is advanced through the notch formed in the first extension, and the second screw is embedded in the second vertebra. Move the proximal end of the proximal portion of the first extension toward the proximal end of the second extension, and bring the outer surface of the second extension into contact with at least the distal edge of the notch, Further moving the proximal end of the proximal portion of the first extension toward the proximal end of the second extension, rotating the lateral surface of the second extension about at least the distal edge of the notch, moving the distal end of the first extension toward the distal end of the second extension, thereby moving the first vertebra toward the second vertebra, Methods that include... 40. The method according to embodiment 39, further comprising coupling a rigid connector with the first screw and the second screw to substantially fix the position of the first screw relative to the second screw.

[0142] The systems, devices, and methods shown in Figures 4A to 4T. Additional embodiments of System 400 for stabilizing the vertebrae through a skin incision S are described herein. In any embodiment disclosed herein, any component, feature, or other detail of System 400 may have any of the components, features, or other details of any other embodiment of System 400 disclosed herein, or may be used in any combination with any of the components, features, or details of System 400 or the method of use disclosed herein, in accordance with any of the steps of any other method embodiment disclosed herein, including, but not limited to, any of the embodiments of System 200 or 300 or the method of use disclosed herein. Similarly, any component, feature, step, or other detail of any other embodiment of System or method disclosed herein may have any of the components, features, steps, or other details of System 400 or the method of use disclosed herein, in any combination with any of the components, features, or details of System 400 or the method of use disclosed herein.

[0143] In some embodiments, the system 400 may include a first screw 402 having a first screw head, a second screw 404 having a second screw head, and a first extension 410 configured to be removably coupled to the first screw 402 at the distal end 410a of the first extension 410, the first extension 410 having a first wall 414 and a first passage 416 extending through the first extension 410 along the axial centerline C of the first extension 410 such that the first wall 414 of the first extension 410 at least partially encloses the first passage 416. In some embodiments, the first screw 402 may be configured to be embedded in a first vertebra 403, and the second screw 404 may be configured to be embedded in a second vertebra 405. The system 400 may further have a second extension 420 configured to be removably coupled to a second screw 404 at the distal end 420a of the second extension 420, the second extension 420 having a second wall 428 (also referred to herein as a wall) and a second passage 426 extending through the second extension 420 along the axial centerline C of the second extension 420 such that the second wall 428 of the second extension 420 encloses the second passage 426 at least partially.

[0144] The first extension may further have an opening 432 (also referred to herein as the first opening) extending through the first wall 414 of the first extension 410. The opening 432 and the first wall 414 of the first extension 410 adjacent to the opening 432 may be sized and configured so that the second extension 420 can advance through the opening 432 in a movable manner, such that the second extension 420 or its axial centerline is constrained or supported at an acute angle A (as shown in Figure 4A) with respect to the axial centerline C of the first extension 410.

[0145] In some embodiments, the first extension portion 410 can be removably coupled to the first screw 402 such that when the first extension portion 410 is coupled to the first screw 402, the axial centerline C of the first extension portion 410 is substantially collinear with the axial centerline C of the first screw 402. The second extension portion 420 can be removably coupled to the second screw 404 such that when the second extension portion 420 is coupled to the second screw 404, the axial centerline C of the second extension portion 420 is substantially collinear with the axial centerline C of the second screw 404. In any of the embodiments disclosed herein, the first extension portion 410 and the second extension portion 420 can be formed in a generally cylindrical shape and / or have a generally tubular shape. Other embodiments can have any other desired cross-sectional shape, including a generally square shape, a triangular cross-sectional shape, an oval cross-sectional shape, a polygonal cross-sectional shape, or any combination of the foregoing. Further, some embodiments of the first extension portion 410 and / or the second extension portion 420 can generally be rigid.

[0146] Further, in some embodiments, at least the distal portion 410c of the first extension portion 410 and / or the second extension portion 420 can have an adjustable length. Similar to other embodiments, the first extension portion 410 can be sized and configured such that in an operative state, the proximal portion 410b of the first extension portion 410 can extend away from the skin incision S and toward the surgeon.

[0147] In some embodiments, the inner dimensions of the first wall 414 of the first extension 410 adjacent to the opening 432 in the first extension 410 can be larger than the outer dimensions of at least a portion of the second extension 420, such that at least a portion of the second extension 420 passes through the opening 432 of the first extension 410 at an acute angle A with respect to the axial centerline C of the first extension 410 and is at least partially surrounded by the first wall 414 of the first extension 410. Furthermore, the proximal portion 410b of the first extension 410 can have an inner cross-sectional size larger than the inner cross-sectional size of the distal portion 410c of the first extension 410. Furthermore, in some embodiments, the inner cross-sectional size of the proximal portion 410b of the first extension 410 can also be larger than the outer cross-sectional size of at least the distal portion of the second extension 420, so that at least the distal portion of the second extension 420 can advance completely through the opening 432 of the first extension 410.

[0148] In some embodiments, the opening 432 in the first extension 410 can pass through the first wall 414 of the first extension 410 at an angle that is acute with respect to the axial centerline C of the first extension 410. In some embodiments, the opening 432 may include a first notch 434 in the first side surface 436 of the first wall 414 and a second notch 440 in the second side surface 442 of the first wall 414, where the second side surface 442 is opposite to the first side surface 436 of the first wall 414. The second notch 440 may be separated from the first notch 434 so that the first notch 434 and the second notch 440 do not overlap or connect. Furthermore, the second notch 440 may be positioned closer to the distal end 410a of the first extension 410 than the first notch 434.

[0149] In some embodiments, the first notch 434 can extend distally from the proximal end 410d of the first extension 410 such that the first wall 414 of the first extension 410 does not form a complete or continuous enclosure around the first passage 416 at the proximal end 410d of the first extension 410. In some embodiments, the first notch 434 can remove at least about 40% of the first wall 414 of the first extension 410 at least the proximal end 410d of the first extension 410. In some embodiments of the first notch 434, it can extend along the length of the first extension 410, which is at least about 30% of the total length of the first extension 410, or at least about 40% of the total length of the first extension 410. Furthermore, in some embodiments, the distal edge 446 of the first notch 434 can be flat and angled downward toward the distal end 410a of the first extension 410.

[0150] In some embodiments, the proximal portion 440a of the second notch 440 can axially overlap with the distal portion 434a of the first notch 434. Furthermore, the second notch 440 can be positioned between the proximal end 410d and the distal end 410a of the first extension 410 such that the proximal portion 440a of the second notch 440 is spaced apart from the proximal end 410d of the first extension 410, and the distal portion 440b of the second notch 440 is spaced apart from the distal end 410a of the first extension 410. In some embodiments, the second notch 440 can remove at least about 40% of the first wall 414 of the first extension 410 in at least the middle portion of the first extension 410. Furthermore, the second notch 440 can extend along the length of the first extension 410, which is at least about 30% of the total length of the first extension 410.

[0151] The second notch 440 may extend along the length of the first extension 410, which is at least about 40% of the total length of the first extension 410. Furthermore, in some embodiments, the proximal edge 448 of the second notch 440 may be curved or flat. In some embodiments, the distal edge 450 of the second notch 440 may be flat and angled downward toward the distal end 410a of the first extension 410. Furthermore, in some embodiments, one or more projections 454 adjacent to the distal edge 450 of the second notch 440 may provide a surface or shoulder that the second extension 420 can contact to limit the range of rotation of the second extension 420 relative to the first extension 410. In some embodiments, the projection 454 is replaced by an inclined notch, which allows for closer proximity between two screws and two extensions, for example, in cases of severe lordosis where the angle A between adjacent screws is severe.

[0152] In some embodiments, the first extension 410 and the second extension 420 may be configured such that, in an operable state in which the second extension 420 is advanced through an opening 432 in the first extension 410, the proximal end of the first extension 410 is moved toward or away from the proximal end of the second extension 420, and the distal end of the second extension 420 is moved toward or away from the distal end 410a of the first extension 410, respectively, so that the second extension 420 can be hinged and / or rotated relative to the first extension 410. For example, but not limited to, moving the proximal end of the first extension 410 toward or away from the proximal end of the second extension 420 can be done by causing the second extension 420 to hinge and / or rotate about the edge of the opening 432 in the first extension 410, so as to move the distal end of the second extension 420 toward or away from the distal end 410a of the first extension 410.

[0153] The hinge effect may, in some embodiments, be generated due to a physical barrier that allows the extension 410 to pass through an opening 434 in the other extension 430. Essentially, the extension 410 can be trapped within a hole (topologically defined) created by an opening or notch in the extension 430. Alternatively, the actual hinge may exist between the extensions 430 and 410 by having complementary projections near the point of contact, creating ball-and-socket hinges, etc. Some embodiments of the system 400 may be configured to generate the hinge effect by imposing constraints on the movement between the extensions 410 and 430. External rings or restraints, as shown in Figure 6F and other embodiments disclosed herein, as well as external blockers to movement, such as those shown in Figures 6O, 6P, and / or 6R, may all be used to restrain movement in order to maintain the hinge effect, which allows for screw compression and reduction and reverse torque during final locking, using the all-in-one system shown in 400. In contrast to conventional techniques where the tower and extension are parallel and designed not to interact, constraints on movement during compression are imposed by external tools. In this invention, the tower and blade intersect and interact directly, so that the extension itself creates a hinge effect by directly limiting and restricting the movement of one extension relative to another. This reduces the need for additional tools and saves time and space during surgery.

[0154] In some embodiments, the first extension 410 and the second extension 420 may be configured such that, in an operable state in which the second extension 420 is advanced through an opening 432 in the first extension 410, contact between the outer surface of the second wall 428 of the second extension 420 and the first wall 414 of the first extension 410 surrounding the opening 432 provides a hinge that allows the second extension 420 to rotate relative to the first extension 410. Furthermore, the first extension 410 may be configured such that, in an operable state, when the second extension 420 advances through the opening 432 of the first extension 410, the first wall 414 of the first extension 410 surrounding the opening 432 prevents or prevents the second extension 420 from rotating beyond a predetermined amount relative to the first extension 410.

[0155] Furthermore, in some embodiments, the first extension 410 may be configured such that, in an operational state, when the second extension 420 is advanced through an opening 432 within the first extension 410 and rotated to contact a first wall 414 of the first extension 410 adjacent to the opening 432, the first wall 414 of the first extension 410 surrounding the opening 432 can restrain the rotation of the second extension 420 relative to the first extension 410, thereby moving the proximal end of the first extension 410 toward or away from the proximal end of the second extension 420, the distal end of the second extension 420 may move toward or away from the distal end 410a of the first extension 410, respectively. As in other embodiments, the proximal portion 410b of the first extension 410 may be configured to be grasped by a surgeon so that the surgeon can apply a rotational force and / or torque force to the first extension 410 about at least the axial centerline C of the distal portion 410c of the first extension 410, causing the first extension 410 to rotate about an axis perpendicular to the axial centerline C of the distal portion 410c of the first extension 410.

[0156] Some embodiments of the second extension 420 may have any of the same features or details as any embodiment of the first extension 410 disclosed herein, including, but not limited to, any details relating to openings, notches, and / or slots formed within the first extension 410. In some embodiments, the second extension 420 may include an opening 460 (also referred to as the second opening) extending through the second wall 428 of the second extension 420, and the opening 460 and the second extension 420 adjacent to the opening 460 may be sized and configured so that the third extension 464 can advance through the opening 460 in the second extension 420 in an operable state so that the third extension 464 is angled acutely with respect to the axial centerline C of the second extension 420. In any embodiment disclosed herein, the third extension 464 may be a standard straight tubular extension configured to facilitate the embedding of the third screw 466 into the third vertebra.

[0157] In some embodiments, the first extension 410 and the second extension 420 may be configured so that the third extension 464 can be advanced in an operable state through an opening 432 in the first extension 410 and through an opening 460 in the second extension 420, such that the third extension 464 is angled acutely with respect to the axial centerline C of the first extension 410 and the axial centerline C of the second extension 420. In some embodiments, as shown in the illustrated embodiment, the third extension 464 may be configured to embed a screw substantially perpendicularly into the third vertebra. In some embodiments, the distal end 464a of the third extension 464 may be positioned between the distal end 410a of the first extension 410 and the distal end 420a of the second extension 420 in an operable state.

[0158] In any embodiment disclosed herein, the second extension 420 may include at least one slot or window 470 extending through the first side surface 472 of the second extension 420, the at least one slot 470 of the second extension 420 being configured to receive and / or allow the connecting element 474 (also referred to herein as a rod or connector) which is configured to extend between the first screw 402 and the second screw 404 in an operable state. Furthermore, in any embodiment disclosed herein, the second extension 420 may include a second slot 476 extending through the second side 478 of the second extension 420 (opposite the first side 472 of the second extension), the second slot 476 also being configured to allow a connecting element 474, configured to extend between the first screw 402 and the second screw 404 in an operable state, to pass through the second slot 476.

[0159] Any embodiment of the system 400 disclosed herein may further include a rigid connecting element 474, a first receiving element coupled to the thread head of a first screw 402, and a second receiving element coupled to the thread head of a second screw 404, wherein the first and second receiving elements may be configured to operably receive the connecting element 474, which may extend between the first and second receiving elements when the first screw 402 and the second screw 404 are, respectively, embedded in the first and second vertebrae 405 in the operable state. In some embodiments, the first extension 410 may include a first slot 480 extending through its first wall, the first slot 480 of the first extension 410, which is configured to allow the connecting element 474, which is configured to extend between the first screw 402 and the second screw 404 in the operable state, to advance through the first slot 480. Referring to Figure 4C, the first extension 410 may also have a second slot 481 configured to receive a connecting element 474 which is configured to extend between the first screw 402 and the second screw 404 in an operable state, and / or to allow the connecting element 474 to pass through it.

[0160] In some embodiments, the first slot 480 of the first extension 410 may extend proximal from the distal end 410a of the first extension 410 to the second notch 440 of the first extension 410. The first slot 480 of the first extension 410 may have a width of less than 50% of the width of the outer surface of the first extension 410.

[0161] As described above, the second extension 420 may include a first slot 470 extending through the second wall 428 of the second extension 420, the first slot 470 of the second extension 420 being configured to allow a connecting element 474, configured to extend between the first screw 402 and the second screw 404 in an operable state, to be advanced through the first slot 470 of the second extension 420. In some embodiments, the first slot 470 of the second extension 420 may extend proximal from the distal end 420a of the second extension 420 to the second notch 440 of the second extension 420. Furthermore, the first slot 470 of the second extension 420 may have a width of less than 50% of the width of the outer surface of the second extension 420.

[0162] In some embodiments, the first slot 470 of the second extension 420 may be located within the first side surface 472 of the second wall 428 of the second extension 420, and the second extension 420 may further include a second slot 476 extending through the second side surface 478 of the second wall 428 of the second extension 420, where the second side surface 478 of the second wall 428 is opposite to the first side surface 472 of the second wall 428. The second slot 476 of the second extension 420 may be configured to allow a connecting element 474, configured to extend between the first screw 402 and the second screw 404 in an operable state, to be advanced through the second slot 476 of the second extension 420. In some embodiments, the second slot of the second extension 420 can extend proximal from the distal end of the second extension 420 and may have a length of 40% (or about 40%) or more of the length of the second extension 420, or 30% (or about 30%) or more of the length of the second extension 420.

[0163] Some embodiments of methods for treating spinal defects include implanting a first screw 402, which can be coupled to a first extension 410 (as shown in Figures 4H to 4I), into a first vertebra 403 through an incision. Note that in some embodiments, a tool that is removably coupled to any of the screws disclosed herein can be advanced through either a guide element or an extension and removably engaged with the screw head of the screw to implant the screw. Furthermore, referring to Figures 4J to 4K, a second extension 420, which can be coupled to a second screw 404, can be advanced through an incision and through an opening 432 formed in the first extension 410, such that the axial centerline C of the second extension 420 can be at an acute angle A with respect to the axial centerline C of the first extension 410, and the second screw 404 can be implanted into a second vertebra 405. Furthermore, as described above, referring to Figures 4L to 4M, if two levels of fixation are desired, the third extension 464 can be advanced through the opening 432 of the first extension and the opening 460 of the second extension 420 so that the third screw 466 can be embedded in the third vertebra 467. Referring to Figures 4L to 4M, the third screw 466 can be embedded in the third vertebra 467 between the first vertebra 403 and the second vertebra 405 by advancing the third extension 464 through the first and second notches 434, 440 of the first extension 410 and the first and second notches 434, 440 of the second extension 410. If only two levels of fixation are desired, the first extension 410 and the second extension 420 can be joined using screws that are positioned within adjacent vertebrae, or, in other embodiments, not positioned within adjacent vertebrae.

[0164] In any embodiment disclosed herein, the screw may be embedded by other means, and the extension or guide element may be coupled to the screw head or other components coupled to the screw after the screw has been embedded. In any embodiment disclosed herein, the extension, guide element, and / or tower may be used in conjunction with any of the devices or components illustrated and described in relation to Figures 1A to 1Z, including, but not limited to, wires 140a, 140b, screw 110, insertion part 116a, and / or screw head 114. For example, in any embodiment, but not limited to, first and second extensions 410, 420 may pass over either of the wires 140a, 140b and be fixed to the screw 110 or screw head 114 so that the first and second extensions 410, 420 are coupled to the screw 110 or screw head 114 for further treatment as disclosed herein or in another manner.

[0165] In some embodiments, the third extension 464 can be supported within the opening 432 of the first extension 410 and the opening 460 of the second extension 420, such that the third extension 464 is confined to a position that is acute with respect to the axial centerline C of the second extension 420 and / or the first extension 410. The method or procedure may also include, for example, moving the proximal portion 410b of the first extension 410 toward the proximal portion of the second extension 420, such that the outer surface of the second extension 420 hinges with respect to the second extension 420 by contacting at least the distal edge 446 of the opening 432 of the first extension 410 or other contact surfaces of the first extension 410. In this configuration, the second extension 420 can be moved toward the distal end of the first extension 410 toward the distal end of the second extension 420 by further moving the proximal portion 410b of the first extension 410 toward the proximal portion of the second extension 420, thereby rotating the second extension 420 around a hinge point which can also be the distal edge 446 of the opening 432 or another contact surface of the first extension 410. This method or procedure can be used to move the first vertebra 403 into which the first screw 402 is embedded toward the second vertebra 405 into which the second screw 404 is embedded, and / or move the first vertebra 403 into which the first screw 402 is embedded and the second vertebra 405 into which the second screw 404 is embedded toward the third vertebra 467 into which the third screw 466 is embedded.

[0166] Referring to Figures 4N to 4T, in order to fix the first and second vertebrae 405 in the desired position, the surgeon can connect a rigid connecting element 474 to the first screw 402, the second screw 404, and / or the third screw 466 to roughly fix the position of the first screw 402 relative to the second screw 404 and / or the third screw 466. A connecting element insertion device 484 may be used to advance the connecting element 464 through the openings, channels, and / or slots of the first extension 410, the second extension 420, and / or the third extension 466 into the channels or tulips to which it is connected to the first screw 402, the second screw 404, and / or the third screw 466. A second connection element insertion device 485 is also used in conjunction with the connection element insertion device 484 to advance the connection element 464 through the openings, channels, and / or slots of the first extension 410, the second extension 420, and / or the third extension 466 into the channels or tulips that are coupled with the first screw 402, the second screw 404, and / or the third screw 466.

[0167] For example, but not limited to, the second connection element insertion device 485 can push the connection element 464 out of the connection element insertion device 484 and hold the connection element 464 in the desired position when the connection element insertion device 484 is removed. The second connection element insertion device 485 can then allow the cap to be retained through the third extension 464, locking the connection element 464 and also allowing it to be retracted up to the third screw. At this point, in some embodiments, the third screw 466 can be tightened to the final torque (i.e., to the final torque tightening).

[0168] In some embodiments, the second connection element insertion device 485 may have variable-length blades so that both blades can contact the connection element 464 on both sides of the third tower 464 even when the connection element 464 is more vertical in orientation. The variable blade length of some embodiments of the second connection element insertion device 485 may then be used to push the connection element 464 down until the connection element 464 becomes horizontal and seated in all three seats or receiving elements of the first, second, and third screws. Once the connection element 464 has descended into the screw seats, the second connection element insertion device 485 can be used to hold the connection element 464 downward when the connection element insertion device 484 is removed, to secure the connection element 464 in place by leaving the cap in the third tower, and even to retract the connection element 464 into the third tower in the case of spondylolisthesis.

[0169] In any embodiment, it is important to note that the first, second, and third extensions 410, 420, and 464 coupled to the screw extend outward through the incision, and their proximal ends can provide a “handle” that allows the surgeon to always know the position and orientation of the three screw heads. This arrangement also allows the robotic system to “know” the orientation and position of all the screw heads, and as a result, the robotic system can lower the connecting element 464 directly into the screw heads, including rotating the connecting element 464 from vertical to horizontal to place it into the seat of the screw head. Any of the extensions may have additional components that are added to it or otherwise configured to be integrated into the robotic system. The extensions can then be removed and withdrawn from the body.

[0170] In addition, stereotactic intraoperative navigation and robotic assistance have been implemented in spinal fusion. Both navigation and robotic guidance have been used to guide the trajectory of pedicle screws, either using guidewires or direct screw placement into the vertebra. However, to date, neither stereotactic navigation nor robotics has been used to assist in aligning the screw head or assisting in the placement of the rod or connecting element into the seat of the screw head. Finally, in the natural lumbar lordosis, particularly at L4, L5, and S1 (where 80% of all fusions occur), conventional towers or extensions connected to pedicle screws typically cross the path and interfere with each other during minimally invasive screw placement. Typically, the towers intersect at the incision but remain adjacent to each other. In the embodiments disclosed herein, the towers are designed to intersect within each other. Thus, there is no interference with the intersecting trajectory of the screw extension element and the tower. Furthermore, by having an attachment to the proximal end of the extension, a robotic arm can be attached, and thus the specific three-dimensional orientation of each tower or extension relative to each other can be "known".

[0171] By computer modeling and "knowing" the 3D spatial composition of each component, the robotic system can embed a screw 402 having an extension 410, and then a screw 404 having an extension 440. The robotic system can adjust the two extensions, thereby adjusting the screws attached to them to align the screw heads. Next, the robotic system can insert a third screw for two levels of fastening. As the screw heads are aligned and channels are formed between the towers by notches and openings, a natural space exists for a rod or extension element to be inserted by another robotic arm. In this way, the entire process from locating the pedicle screw trajectory to screw insertion, screw head alignment, rod insertion, and then locking cap insertion is performed. The final locking step, involving tower compression, can also be performed by the same robotic arm by compressing the proximal ends of the extension towers together and finally locking the connecting element or rod using the locking cap. The entire process can be performed by a streamlined process without the risk of interference between different screw paths due to lumbar lordosis.

[0172] Specific aspects of the systems, devices, components, and / or methods described above or illustrated with reference to Figures 4A to 4T are also encompassed by the following numbered embodiments. These numbered embodiments are intended to cover systems, devices, components, and / or methods including, but not limited to, the embodiments of Figures 4A to 4T, and therefore these numbered embodiments may encompass other embodiments as described throughout this specification. 1. A system for stabilizing the vertebrae through a skin incision, A first screw having a first screw head, A second screw having a second screw head, A first extension is configured to be removably coupled to a first screw at the distal end of the first extension, the first extension having a wall and a first passage extending through the first extension along the axial centerline of the first extension, the wall of the first extension at least partially surrounding the first passage, A second extension is configured to be removably coupled to a second screw at the distal end of the second extension, the second extension having a wall and a second passage extending through the second extension along the axial centerline of the second extension, the wall of the second extension at least partially encloses the second passage, A first opening extending through the wall of the first extension, Equipped with, A system in which the walls of a first opening and a first extension adjacent to the first opening are sized and configured such that the second extension can advance through the first opening so that the second extension is confined within the first opening and positioned at an acute angle with respect to the axial centerline of the first extension. 2. The system according to Embodiment 1, wherein the first extension is detachably connectable to the first screw such that when the first extension is connected to the first screw, the axial centerline of the first extension is substantially colinear with the axial centerline of the first screw, and the second extension is detachably connectable to the second screw such that when the second extension is connected to the second screw, the axial centerline of the second extension is substantially colinear with the axial centerline of the second screw. 3. The system according to Embodiment 1 or 2, wherein the first and second extensions are formed into a substantially cylindrical shape. 4. The system according to any one of the embodiments described above, wherein the first extension and the second extension are substantially rigid. 5. The system according to any one of the embodiments described above, wherein the first extension and the second extension have a tubular shape. 6. The system according to any one of the above embodiments, wherein at least the distal portion of the first extension has an adjustable length. 7. The system according to any one of the above embodiments, wherein the first screw is configured to be embedded in a first vertebra, and the second screw is configured to be embedded in a second vertebra. 8. The system according to any one of the above embodiments, wherein the first extension is sized and configured such that, in the operational state, the proximal portion of the first extension extends away from the skin incision toward the surgeon. 9. The system according to any one of the above embodiments, wherein the inner dimensions of the wall of the first extension adjacent to the first opening in the first extension are greater than the outer dimensions of at least a portion of the wall of the second extension, such that at least a portion of the second extension passes through the first opening of the first extension at an acute angle with respect to the axial centerline of the first extension and is at least partially surrounded by the wall of the first extension. 10. The proximal portion of the first extension has an inner cross-sectional size that is larger than the inner cross-sectional size of the distal portion of the first extension. The inner cross-sectional size of the proximal portion of the first extension is also larger than the outer cross-sectional size of the outer cross-sectional size of the at least distal portion of the second extension, so that at least the distal portion of the second extension can be fully advanced through the first opening of the first extension. The system described in any one of the embodiments described above. 11. The system according to any one of the above embodiments, wherein the first opening of the first extension passes through the wall of the first extension at an angle that is acute with respect to the axial centerline of the first extension. 12. The system according to any one of the above embodiments, wherein the first opening comprises a first notch in a first side surface of the wall and a second notch in a second side surface of the wall of the first extension, the second side surface of the wall facing the first side surface of the wall, the second notch being separated from the first notch, and as a result the first and second notches not overlapping or connecting, and the second notch being positioned closer to the distal end of the first extension than the first notch. 13. The system according to Embodiment 12, wherein the first notch extends distally from the proximal end of the first extension such that the wall of the first extension does not form a complete or continuous enclosure around the first passage at the proximal end of the first extension. 14. The system according to embodiment 12 or 13, wherein the first notch removes at least about 40% of the wall of the first extension at at least the proximal end of the first extension. 15. The system according to any one of embodiments 12 to 14, wherein the first notch extends along the length of the first extension, which is at least about 30% of the total length of the first extension. 16. The system according to any one embodiment 12 to 15, wherein the first notch extends along the length of the first extension, which is at least about 40% of the total length of the first extension. 17. The system according to any one of embodiments 12 to 16, wherein the distal edge of the first notch is planar and angled downward toward the distal end of the first extension. 18. The system according to any one of embodiments 12 to 17, wherein the proximal portion of the second notch overlaps axially with the distal portion of the first notch. 19. The system according to any one of embodiments 12 to 18, wherein the second notch is positioned between the proximal and distal ends of the first extension such that the proximal end of the second notch is spaced apart from the proximal end of the first extension and the distal end of the second notch is spaced apart from the distal end of the first extension. 20. The system according to any one of embodiments 12 to 19, wherein the second notch removes at least about 40% of the wall of the first extension in at least the middle portion of the first extension. 21. The system according to any one of embodiments 12 to 20, wherein the second notch extends along the length of the first extension, which is at least about 30% of the total length of the first extension. 22. The system according to any one embodiment 12 to 21, wherein the second notch extends along the length of the first extension, which is at least about 40% of the total length of the first extension. 23. The system according to any one of embodiments 12 to 22, wherein the proximal edge of the second notch is curved. 24. The system according to any one of embodiments 12 to 23, wherein the distal edge of the second notch is planar and angled downward toward the distal end of the first extension. 25. The system according to any one of the above embodiments, wherein the first and second extensions are configured such that, in a movable state in which the second extension is advanced through a first opening in the first extension, moving the proximal end of the first extension toward or away from the proximal end of the second extension is such that the second extension is hinged about the edge of the first opening and rotated relative to the first extension about the edge of the first opening in the first extension, respectively, so as to move the distal end of the second extension toward or away from the distal end of the first extension. 26. The system according to any one of the above embodiments, wherein the first and second extensions are configured such that, in a movable state in which the second extension is advanced through a first opening of the first extension, contact between the outer surface of the wall of the second extension and the wall of the first extension surrounding the first opening provides a hinge that allows the second extension to rotate relative to the first extension. 27. The system according to any one of the above embodiments, wherein, in an operational state, when the second extension advances through the first opening in the first extension, the walls of the first extension surrounding the first opening prevent the second extension from rotating beyond a predetermined amount relative to the first extension. 28. The system according to any one of the embodiments described above, wherein, in an operational state, when the second extension is advanced through the first opening of the first extension and rotated to contact the wall of the first extension adjacent to the first opening, the wall of the first extension surrounding the first opening restrains the rotation of the second extension relative to the first extension, thereby causing the proximal end of the first extension to move toward or away from the proximal end of the second extension, respectively, to move the distal end of the second extension toward or away from the distal end of the first extension. 29. The system according to any one of the above embodiments, wherein the proximal portion of the first extension is configured to be grasped by a surgeon so that the surgeon can apply a rotational force and / or a torque force to the first extension about at least the axial centerline of the distal portion of the first extension, so as to rotate the first extension about an axis perpendicular to the axial centerline of the distal portion of the first extension. 30. The system according to any one of the above embodiments, wherein the second extension comprises a second opening extending through the wall of the second extension, and the second opening and the second extension adjacent to the second opening are sized and configured so that the third extension can be advanced through the second opening in a movable state so that the third extension is angled acutely with respect to the axial centerline of the second extension. 31. The system according to Embodiment 30, wherein the first and second extensions are configured such that the third extension can advance through the first opening of the first extension and the second opening of the second extension in an operable state, such that the third extension is inclined at an acute angle with respect to the axial centerline of the first extension and the axial centerline of the second extension. 32. The system according to embodiment 30 or 31, wherein the distal end of the third extension is positioned between the distal end of the first extension and the distal end of the second extension when in an operational state. 33. The system according to any one of embodiments 30 to 32, wherein the third extension portion has a tubular shape. 34. The system according to any one of the above embodiments, wherein the second extension comprises at least one slot extending through the wall of the second extension, and the at least one slot of the second extension is configured to receive a connecting element which is configured to extend between the first screw and the second screw in an operable state. 35. Rigid connection elements, A first receiving element coupled to the first screw head, A second receiving element coupled to the second screw head, Furthermore, The first and second receiving elements are configured to operably receive the connecting element, and in the operable state, when the first and second screws are embedded in the first and second vertebrae, respectively, the connecting element extends between the first and second receiving elements. The system described in any one of the embodiments described above. 36. The system according to any one of the above embodiments, wherein the first extension portion comprises a first slot extending through its wall, the first slot of the first extension portion being configured to allow a connecting element, configured to extend between a first screw and a second screw in an operable state, to be advanced through the first slot. 37. The system according to embodiment 36, wherein the first slot of the first extension extends proximal from the distal end of the first extension to the second notch of the first extension. 38. The system according to embodiment 36, wherein the first slot of the first extension has a width of less than 50% of the width of the outer surface of the first extension. 39. The system according to any one of the above embodiments, wherein the second extension portion comprises a first slot extending through the wall of the second extension portion, the first slot of the second extension portion being configured to allow a connecting element, configured to extend between the first screw and the second screw in an operable state, to be advanced through the first slot of the second extension portion. 40. The system according to embodiment 39, wherein the first slot of the second extension extends proximal from the distal end of the second extension to the second notch of the second extension. 41. The system according to embodiment 39, wherein the first slot of the second extension has a width of less than 50% of the width of the outer surface of the second extension. 42. The system according to Embodiment 39, wherein the first slot of the second extension is located on the first side of the wall of the second extension, and the second extension further comprises a second slot extending through the second side of the wall of the second extension, the second side of the wall of the second extension facing the first side of the wall of the second extension, and the second slot of the second extension is configured to allow a connecting element configured to extend between the first screw and the second screw in an operable state to advance through the second slot of the second extension. 43. The system according to embodiment 42, wherein the second slot of the second extension extends proximal from the distal end of the second extension and has a length of about 40% or more of the length of the second extension. 44. A method for stabilizing the vertebrae of the spine, The first screw, which is connected to the first extended portion, is embedded in the first vertebra through the incision. The second extension, which is connected to the second screw, is advanced through the incision and through the first opening formed in the first extension, such that the axial center line of the second extension is at an acute angle with respect to the axial center line of the first extension. The second screw is embedded in the second vertebra, The proximal portion of the first extension is moved toward the proximal portion of the second extension, and the outer surface of the second extension is brought into contact with at least the distal edge of the first opening within the first extension. Further moving the proximal portion of the first extension toward the proximal portion of the second extension, rotating the second extension about at least the distal edge of the first opening, moving the distal end portion of the first extension toward the distal end portion of the second extension, thereby moving the first vertebra toward the second vertebra, Methods that include... 45. The method according to embodiment 44, further comprising coupling a rigid connector with the first screw and the second screw to substantially fix the position of the first screw relative to the second screw. 46. ​​A system for bone stabilization, A first screw having a first screw head, A first guide element configured to extend away from the first screw, wherein the first guide element is A partially enclosed tubular body extending along a first longitudinal axis between a proximal end and a distal end, wherein the distal end of the partially enclosed tubular body is configured to engage with a first screw head, An opening extending through the middle portion of a partially enclosed tubular body, the opening being oriented at an angle with respect to a first longitudinal axis, A system that includes these features. 47. Partially enclosed tubular bodies are A partially enclosed tubular section having an inner concave surface facing a first direction and an outer convex surface facing a second direction opposite to the first direction, with a proximal portion proximal to the intermediate section, The intermediate section comprises a distal portion of a distal portion, having an inner concave surface facing a second direction and an outer convex surface facing a first direction, and a partially enclosed tubular section. The system according to embodiment 46, comprising: 48. The system according to embodiment 47, wherein the proximal portion surrounds a surface of at least 180°. 49. The system according to embodiment 47 or 48, wherein the distal portion surrounds a surface of at least 180°. 50. The system according to any one of embodiments 47 to 49, wherein the distal portion comprises a longitudinal slot extending to the distal end of a partially enclosed tubular body. 51. A second screw having a second screw head, A second guide element configured to extend away from the second screw, Furthermore, The second guide element is configured to pass through the opening of the first guide element. The system according to any one of embodiments 47 to 50. 52. The second inductive element is, A partially enclosed tubular body extending along a second longitudinal axis between a proximal end and a distal end, wherein the distal end of the partially enclosed tubular body is configured to engage with a second screw head, An opening extending through the middle portion of a partially enclosed tubular body, the opening extending at an angle with respect to a second longitudinal axis, The system according to embodiment 51, comprising: 53. The partially enclosed tubular body of the second induction element is A partially enclosed tubular section having an inner concave surface facing a third direction and an outer convex surface facing a fourth direction opposite to the third direction, with a proximal portion proximal to the intermediate section, A partially enclosed tubular section having an inner concave surface facing a fourth direction and an outer convex surface facing a third direction, with a distal portion at the distal end of the intermediate section, The system according to embodiment 52, comprising: 54. A third screw having a third screw head, A third guide element configured to extend away from the third screw, Furthermore, The third guide element is configured to pass through the openings of the first and second guide elements. The system described in Embodiment 53. 55. The system according to embodiment 54, wherein the third induction element comprises a tubular body. 56. The system according to embodiment 55, wherein the third guide element includes a longitudinal slot for facilitating the passage of a rod. 57. The system according to any one of embodiments 46 to 56, further comprising a rod inserter configured to deliver a rod. 58. The system according to embodiment 57, further comprising a rod catcher configured to release a rod from a rod inserter. 59. A system for bone stabilization, It has multiple guiding elements, and each of the multiple guiding elements is A partially enclosed tubular body extending between a proximal end and a distal end, wherein the distal end of the partially enclosed tubular body is configured to engage with a screw head, An opening extending through the intermediate portion of a partially enclosed tubular body, the opening being oriented at an angle to the longitudinal axis of the guide element, Equipped with, Each opening in the multiple guide elements is sized and configured to allow passage through another guide element. system. 60. Multiple induction elements include a first induction element and a second induction element, and the first induction element and the second induction element are, A partially enclosed tubular section having an inner concave surface facing a first direction and an outer convex surface facing a second direction opposite to the first direction, with a proximal portion proximal to the intermediate section, The intermediate section comprises a distal portion of a distal portion, having an inner concave surface facing a second direction and an outer convex surface facing a first direction, and a partially enclosed tubular section. Equipped with, The second guide element is configured to pass through an opening in the first guide element, and when the second guide element passes through the opening in the first guide element, the inner concave surfaces of the proximal portions of the first and second guide elements face each other. The system described in Embodiment 59. 61. The system according to embodiment 59 or 60, wherein the plurality of guide elements comprises a first guide element, a second guide element, and a third guide element, wherein an opening extending through the middle section of the first guide element is sized and configured to allow the second guide element to pass through it, and an opening extending through the middle section of the third guide element is sized and configured to allow the first and second guide elements to pass through it when the second guide element passes through the opening of the first guide element.

[0173] The systems, devices, and methods shown in Figures 5A to 5K. Embodiments relating to System 500 for stabilizing vertebrae through a skin incision S are described below. In any embodiment disclosed herein, any component, feature, or other detail of System 500 may have any of the components, features, or other details of any other system embodiment disclosed herein, or may be used in any combination with any of the components, features, or details of System 500 or the method of use disclosed below, in accordance with any of the steps of any other method embodiment disclosed herein, including, but not limited to, any of the embodiments of System 200, 300, and / or 400 or the method of use thereof described above. Similarly, any component, feature, step, or other detail of any other system or method embodiment disclosed herein may have any of the components, features, steps, or other details of any embodiment of System 500 or the method of use disclosed herein, in any combination with any of the components, features, or details of the system.

[0174] In any embodiment disclosed herein, the system 500 may have, for example, a blade having an opening that can be positioned at various lengths relative to the screw head. The opening may be sized and configured to allow other screws and towers or other guide elements or extensions to pass through the opening.

[0175] In any embodiment disclosed herein, the blades can then be attached to or coupled to a screw by any suitable mounting mechanism. In some embodiments, but not limited to, one or more wires, including wires 140a, 140b, may be used to couple the blades to the screw heads. Once a desired number of towers are engaged with the screw heads, in any embodiment disclosed herein, one or more connectors or caps can couple each pair of blades together, closing the towers and increasing the rigidity of the blades and towers. In addition, in any embodiment disclosed herein, the blades may have one or more stiffeners or reinforcements proximal or distal to the opening to increase the bending rigidity of the blades, or the proximal and distal portions of the blades may have increased rigidity to reduce the flexibility of the towers in use.

[0176] In some embodiments, the system 500 may include a first screw 502 which may include a first screw head 504, the first screw head 504 which includes a first side 506 and a second side 508, the first side 506 and the second side 508 being opposite to each other, and the first guide element 510 is configured to extend away from the first screw 502. In any embodiment disclosed herein, the first guide element 510 may include a first blade 520 which extends along a first longitudinal axis A1 between the proximal end 520a and the distal end 520a of the first blade 520. The first blade 520 may include a curved intermediate section 524 between the proximal end 520a and the distal end 520b. The distal end 520b of the first blade 520 may be configured to engage with or connect to the first side 506 of the first screw head 504.

[0177] The first guide element 510 may further include a second blade 530 extending along a second longitudinal axis A2 between a proximal end 530a and a distal end 530b. The second blade 530 may include a curved intermediate section 534 between the proximal end 530a and the distal end 530b. The distal end 530b of the second blade 530 may be configured to engage with a second side surface 508 of the first screw head 504. The first guide element 510 may be configured such that when the distal end 520b of the first blade 520 and the distal end 530b of the second blade 530 engage with the first screw head 504, the inner surface 520c of the first blade 520 faces and is spaced apart from the inner surface 530c of the second blade 530. Furthermore, in some embodiments, the curved intermediate sections 524, 534 of the first and second blades 520, 530 can form an enlarged opening 540 having an increased spacing between the inner surfaces 520c, 530c of the first and second blades 520, 530 relative to the intermediate sections 524, 534, with respect to the spacing between the inner surfaces of the first and second blades 520, 530 proximal and distal to the intermediate sections 524, 534.

[0178] In any embodiment, the first and second longitudinal axes A1, A2 may be parallel to each other when the distal ends 520b, 530b of the first blade 520 and the second blade 530 engage with the first screw head 504. Furthermore, in some embodiments, the curved intermediate sections of the first blade 520 and the second blade 530 may be bent outward in an arc shape and may have a curved or rounded shape. In any other embodiment, the intermediate sections of the first blade 520 and the second blade 530 may be bent outward toward the midpoint of the intermediate section and may have an inclined or tapered shape. The first blade 520 and the second blade 530 may be bent inward proximal to the midpoint of the intermediate section.

[0179] In some embodiments, the enlarged opening 540 of the first guide element 510 can be oriented parallel or substantially parallel to the inner surfaces of the first and second blades 520, 530. Furthermore, in any embodiment disclosed herein, each of the first blade 520 and the second blade 530, and / or any blade of any guide element disclosed herein, may have substantially uniform cross-sectional thickness from the proximal end to the distal end.

[0180] In some embodiments, the enlarged opening 540 of the first guide element 510 may be configured to allow the passage of a subsequent guide element or a plurality of subsequent guide elements, including, but not limited to, an enlarged intermediate portion of a subsequent guide element or a plurality of subsequent guide elements. For example, in some embodiments, the enlarged opening 540 between the first blade 520 and the second blade 530 may be sized and configured to allow the passage of a second screw and the second guide element 510, including an enlarged intermediate section of the second guide element.

[0181] Referring to Figure 5B, some embodiments of the guide element 510 can be configured such that a first blade 520 has a proximal section 540 and a distal section 542, and a second blade 530 has a proximal section 544 and a distal section 546, with an intermediate section 524 of the first blade 520 located between the proximal section 540 and the distal section 542 of the first blade 520, and an intermediate section 534 of the second blade 530 located between the proximal section 540 and the distal section 542 of the second blade 530. In any embodiment disclosed herein, the proximal sections 540 and 544 of the first and second blades 520 and 530, and / or the distal sections 542 and 546 of the first and second blades 520 and 530, may be planar or substantially planar and parallel to each other.

[0182] In some embodiments, the distance of the increased gap between the inner surface of the third blade 560 and the inner surface of the fourth blade 564 of the second guide element 550 (for example, in the enlarged opening 540) can be smaller than the distance of the increased gap between the inner surface of the first blade 520 and the inner surface of the second blade 530 (for example, in the enlarged opening 540). For example, in any embodiment disclosed herein, but not limited to, the width WO of the guide element from the inner surface of the first blade to the inner surface of the second blade at the widest point of the opening (as shown in Figure 5B) may be about 100% greater (i.e., twice as wide) than the width WP from the inner surface of the first blade to the inner surface of the second blade in the proximal portion (e.g., the proximal portions 540, 544 of the first and second blades 520, 530), or 80% (or about 80%) greater to 400% (or about 400%) or more greater than the width WP from the inner surface of the first blade to the inner surface of the second blade in the proximal portion. In any embodiment disclosed herein, the proximal and distal portions of the guide element may have substantially the same width or may have different widths.

[0183] In any embodiment disclosed herein, the guide element may have any of a range of lengths suitable for a range of different sizes of biomimetic structures, thereby enabling a surgeon to select one or more desired lengths of the blade and the position of the expanding opening, for example, after measuring the depth of the tissue. Referring to Figure 5D, the guide element 510 may be provided in various lengths, and the length of the distal portion LD to the distal edge of the expanding opening 540 may vary. For example, but not limited to, a kit may be provided in which the system has a range of guide elements 510 having a range of total lengths of the distal portion of the guide element and a range of lengths LD. As shown in Figure 5D, some embodiments of the guide element 510 may have a distal portion having a length LD1 which is shorter than a second guide element 510 having a distal portion having a length LD2. LD2 may also be shorter than the length of a third guide element 510 having a distal portion having a length LD3, and length LD3 may be shorter than that of a fourth guide element 510 having a distal portion having a length LD4. LD4 can be shorter than the length of the fifth guide element 510 having a distal portion having length LD5. In any embodiment, the length of the total length and / or the distal portion LD may be 10% (or about 10% or less) greater than each of the consecutive sizes, or 15% (or about 15%) greater than each of the consecutive sizes, or 20% (or about 20% or more) greater than each of the consecutive sizes.

[0184] For example, but not limited to, the enlarged opening in any embodiment of the guide element disclosed herein may be oriented at any desired angle (e.g., a perpendicular angle, or any acute or non-perpendicular angle) with respect to the longitudinal axis of the guide element, such that the enlarged opening in the guide element may be at any desired angle when the distal ends of the first and second blades engage with the first screw head.

[0185] In some embodiments, referring to Figures 5E to 5G, the enlarged opening 540 of the first guide element 510 may be oriented at an angle with respect to the axial centerline axis C (also referred to as the longitudinal axis) when the distal ends of the first blade 520 and the second blade 530 engage with the first screw head 504, for example. For example, as shown in Figure 5E, the first opening 540 of the first guide element 510 (or any other guide element, including a second guide element, a third guide element, etc.) may be at an angle A1 with respect to the centerline axis C, which may be 90° (or approximately 90°). As shown in Figure 5F, the first opening 540 of the first guide element 510 (or any other guide element including a second guide element, a third guide element, etc.) may be at an angle A2 with respect to the center axis C, which may be less than 90°, for example, 70° (or about 70°) with respect to the center axis C or 50° (or about 50°) to 75° (or about 75°) with respect to the center axis C. As shown in Figure 5G, the first opening 540 of the first guide element 510 (or any other guide element including a second guide element, a third guide element, etc.) may be at an angle A3 smaller than A2 with respect to the center axis C, for example, 45° (or about 45°) with respect to the center axis C or 30° (or about 30°) to 50° (or about 50°) with respect to the center axis C.

[0186] In this configuration, referring to Figure 5H, the first guide element 510 can have an enlarged opening 540 at an angle A with respect to the center axis C of the first guide element 510, which allows the second guide element 550 to pass through. As a result, the second guide element 550 can be oriented such that, in the operable state shown in Figure 5H, the center axis C of the second guide element 550 is also inclined at the same angle A with respect to the center axis as the enlarged opening 540 of the first guide element. In this case as well, the angle A of the first guide element can be any desired angle. In any embodiment, the angle of the enlarged opening can be an acute or non-perpendicular angle, such as angle A2 or angle A3 shown in Figures 5E and 5F. This angle may range within the kit from 20° (or about 20°) or less to 70° (or about 70°) or more, or from 40° (or about 40°) to 60° (or about 60°). In any embodiment disclosed herein, the second guide element 550 or the third guide element 582 may have a substantially planar blade as shown, or it may also have an enlarged opening configured to allow passage of the third guide element.

[0187] In any embodiment disclosed herein, as shown in Figure 5C, the system 500 may further include a second guide element 550, which may have any of the same features, components, and / or other details as any of the embodiments of the first guide element 510 disclosed herein, including an enlarged opening at any desired angle. The second guide element 550 may include a second screw 552 which may include a second screw head 554 having a first side 556 and a second side 558, the first side 556 and the second side 558 being opposite to each other. The second guide element 550 may be configured to extend away from the second screw 552 and may include a third blade 560 which extends along a third longitudinal axis between a proximal end 560a and a distal end 560b, the distal end 560b of the third blade 560 being configured to engage with the first side 556 of the second screw head 554. The second guide element 510 may also include a fourth blade 564 extending along a fourth longitudinal axis A4 between a proximal end 564a and a distal end 564b, the distal end 564b of the fourth blade 564 being configured to engage with a second side surface 558 of the second screw head 554.

[0188] Similar to the first blade 520, the third blade 560 may include a curved intermediate section 566 between its proximal end 560a and distal end 560b, and the fourth blade 564 may include a curved intermediate section 568 between its proximal end 564a and distal end 564b. Furthermore, in some embodiments, the curved intermediate sections 566, 568 of the third and fourth blades 560, 564 may form an enlarged opening 570 having an increased spacing between the inner surfaces 560c, 564c of the third and fourth blades 560, 564 relative to the spacing between the inner surfaces of the proximal and distal first blades 560 and second blades 564.

[0189] In some embodiments, the distal ends 560b, 564b of the third and fourth blades can engage with the second screw head 554. Furthermore, the inner surface 560c of the third blade 560 can face the inner surface 564c of the fourth blade 564 and be spaced apart from it.

[0190] In some embodiments, referring to Figures 5C and 5I-5K, the enlarged opening 570 of the second guide element 550 may be configured to allow the passage of a subsequent guide element or a plurality of subsequent guide elements, including, but not limited to, a subsequent guide element or an enlarged intermediate section of a plurality of subsequent guide elements, or a subsequent guide element having a substantially straight or planar blade. For example, in some embodiments, but not limited to, the enlarged opening 570 between the third blade 560 and the fourth blade 564 may be sized and configured to allow the passage of a third screw 580 and a third guide element 582, the third guide element 582 having a substantially flat blade or a guide element having an enlarged intermediate section.

[0191] In any embodiment, as shown in Figures 5I to 5K, the size and / or orientation of the enlarged opening 570 between the third and fourth blades of the second guide element 550 may differ from the orientation of the enlarged opening 540 between the first blade 520 and the second blade 530 of the first guide element 540. Furthermore, in any embodiment disclosed herein, the longitudinal position of the enlarged opening of the second guide element may differ from the longitudinal position of the enlarged opening of the second guide element.

[0192] In some embodiments, the third guide element may have an enlarged opening configured to allow passage of the first and second guide elements. In some embodiments, the third guide element may have an enlarged opening having any of the features or details of any of the embodiments disclosed herein, and the first guide element may have an enlarged opening having any of the features or details of any of the embodiments disclosed herein. The second guide element may have an enlarged opening therein, or may have a generally flat blade. In some embodiments, the enlarged opening of the third guide element may be sized and configured to allow passage of the first and second guide elements, and the first guide element may be sized and configured to allow passage of the second guide element.

[0193] In some embodiments, the third guide element may include a fifth blade extending along a fifth longitudinal axis between a proximal and distal end, the fifth blade including either a straight or curved intermediate section between the proximal and distal end, and the distal end of the fifth blade being configured to engage with a first side surface of the third screw head. In some embodiments, the third guide element may have a sixth blade extending along a second longitudinal axis between a proximal and distal end, the sixth blade including either a straight or curved intermediate section between the proximal and distal end, and the distal end of the sixth blade being configured to engage with a second side surface of the third screw head. The inner surface of the fifth blade may face and be spaced apart from the inner surface of the sixth blade, as shown in the figure. In some embodiments, the curved intermediate sections of the fifth and sixth blades can form an enlarged opening having an increased distance between the inner surfaces of the fifth and sixth blades relative to the distance between the inner surfaces of the fifth and sixth blades at the proximal and distal ends of the intermediate section.

[0194] Furthermore, in some embodiments, the increased distance in the increased gap between the inner surfaces of the fifth and sixth blades can be made greater than, if any, the increased distance between the inner surfaces of the first blade 520 and the second blade 530, so that the enlarged opening between the fifth blade and the sixth blade can be sized and configured to allow the passage of the second screw and the second guide element 510, and the passage of the first screw 502 and the first guide element 510.

[0195] Some embodiments of the system 500 for bone stabilization may include a plurality of guide elements, each of which includes a first blade 520 having a proximal end 520a and a distal end 520b, the first blade 520 including a curved intermediate section 524 between the proximal end 520a and the distal end 520b, and a second blade 530 having a proximal end 530a and a distal end 530b, the second blade including a curved intermediate section 534 between the proximal end 530a and the distal end 530b. In some embodiments, the distal ends 520b, 530b of the first blade 520 and the second blade 530 may be configured to engage with the bone screw 502 such that when engaging with the bone screw 502, the inner surface 520c of the first blade 520 faces and is spaced apart from the inner surface 530c of the second blade 530. Furthermore, the curved intermediate sections 524, 534 of the first blade 520 and the second blade 530 may form an enlarged opening 540 in which the spacing between the inner surfaces 520c, 530c of the first blade 520 and the second blade 530 is increased relative to the intermediate sections 524, 534 and the spacing between the inner surfaces 520c, 530c of the first blade 520 and the second blade 530. Furthermore, in some embodiments, the first blade 520 and the second blade 530 of the first guide element 510 among the plurality of guide elements can form an enlarged opening 540 having different longitudinal positions, different spacings between the inner surfaces of the first blade 520 and the second blade 530, and / or different orientations, compared to the enlarged opening formed by the first blade 560 and the second blade 564 of the second guide element 550 among the plurality of guide elements.

[0196] Furthermore, in some embodiments, the system 500 includes a third guide element having an enlarged opening, wherein the first and second blades of the third guide element among the plurality of guide elements can form an enlarged opening having different longitudinal positions, different spacings between the inner surfaces of the first and second blades, and / or different orientations compared to the enlarged opening formed by the first and second blades of the second guide element among the plurality of guide elements. The third guide element can be coupled to the screw head of a third screw.

[0197] Furthermore, in some embodiments, the system 500 includes a fourth guide element having an enlarged opening, wherein the first and second blades of the fourth guide element among the plurality of guide elements can form an enlarged opening having different longitudinal positions, different spacings between the inner surfaces of the first and second blades, and / or different orientations compared to the enlarged opening formed by the first and second blades of the third guide element among the plurality of guide elements, compared to the enlarged opening formed by the first and second blades of the second guide element among the plurality of guide elements, and compared to the enlarged opening formed by the first and second blades of the first guide element among the plurality of guide elements. The fourth guide element may be coupled to the screw head of a fourth screw.

[0198] Furthermore, in some embodiments in which the system 500 includes a fifth guide element having an enlarged opening, the first and second blades of the fifth guide element can form an enlarged opening having different longitudinal positions, different spacings between the inner surfaces of the first and second blades, and / or different orientations compared to the enlarged opening formed by the first and second blades of the fourth guide element among the plurality of guide elements, compared to the enlarged opening formed by the first and second blades of the third guide element among the plurality of guide elements, compared to the enlarged opening formed by the first and second blades of the second guide element among the plurality of guide elements, and compared to the enlarged opening formed by the first and second blades of the first guide element among the plurality of guide elements. The fifth guide element may be coupled to the screw head of the fifth screw.

[0199] Specific aspects of the systems, devices, components, and / or methods described above or illustrated with reference to Figures 5A to 5K are also encompassed by the following numbered embodiments. These numbered embodiments are intended to cover systems, devices, components, and / or methods including, but not limited to, the embodiments in Figures 5A to 5K, and therefore these numbered embodiments may encompass other embodiments as described throughout this specification. 1. A system for bone stabilization, A first screw having a first screw head, wherein the first screw head has a first side surface and a second side surface, and the first side surface and the second side surface are opposite to each other, A first guide element configured to extend away from the first screw, wherein the first guide element is A first blade extending along a first longitudinal axis between a proximal end and a distal end, the first blade comprising a curved intermediate section between the proximal end and the distal end of the first blade configured to engage with a first side of a first screw head, A second blade extending along a second longitudinal axis between a proximal end and a distal end, the second blade having a curved intermediate section between the proximal end and the distal end of the second blade being configured to engage with a second side of the first screw head, Equipped with, When the distal ends of the first and second blades engage with the first screw head, The inner surface of the first blade faces the inner surface of the second blade, spaced apart from it. A system in which the curved intermediate sections of the first and second blades form an enlarged opening having an increased spacing between the inner surfaces of the first and second blades relative to the spacing between the inner surfaces of the first and second blades proximal and distal to the intermediate section. 2. The system according to Embodiment 1, wherein each of the first and second blades includes a proximal section and a distal section, an intermediate section is located between the proximal and distal sections, and the proximal and distal sections are planar or substantially planar and parallel to each other. 3. The system according to any one of the above embodiments, wherein the enlarged opening is oriented at an angle with respect to the first and second longitudinal axes when the distal ends of the first and second blades engage with the first screw head. 4. The system according to any one of the embodiments described above, wherein the enlarged opening is oriented parallel or substantially parallel to the inner surfaces of the first and second blades. 5. The system according to any one of the above embodiments, wherein the first and second longitudinal axes are parallel to each other when the distal ends of the first and second blades are engaged with the first screw head. 6. The system according to any one of the above embodiments, wherein each of the curved intermediate sections of the first blade and the second blade is curved outward. 7. The system according to any one of the embodiments described above, wherein each of the first and second blades has a substantially uniform cross-sectional thickness from the proximal end to the distal end. 8. A second screw having a second screw head, the second screw head having a first side and a second side, the first side and the second side being opposite each other, the second screw, The system further comprises a second guide element configured to extend away from the second screw, wherein the second guide element is A third blade extending along a third longitudinal axis between a proximal end and a distal end, wherein the distal end of the third blade is configured to engage with a first side of the second screw head, A fourth blade extending along a fourth longitudinal axis between its proximal and distal ends, wherein the distal end of the fourth blade is configured to engage with a second side of the second screw head, Equipped with, The enlarged opening between the first blade and the second blade is sized and configured to allow the second screw and the second guide element to pass through the opening. The system described in any one of the embodiments described above. 9. The third blade of the second guide element has a curved intermediate section between its proximal and distal ends, and the fourth blade of the second guide element has a curved intermediate section between its proximal and distal ends, and when the distal ends of the third and fourth blades engage with the second screw head, The inner surface of the third blade faces the inner surface of the fourth blade, spaced apart from it. The curved intermediate sections of the third and fourth blades form an enlarged opening having an increased spacing between the inner surfaces of the third and fourth blades relative to the spacing between the inner surfaces of the third and fourth blades proximal and distal to the intermediate section. The system described in Embodiment 8. 10. The system according to Embodiment 9, wherein the distance of the increased spacing between the inner surfaces of the third and fourth blades is smaller than the distance of the increased spacing between the inner surfaces of the first and second blades. 11. The system according to embodiment 9 or 10, wherein the orientation of the enlarged opening between the third blade and the fourth blade is different from the orientation of the enlarged opening between the first blade and the second blade. 12. The system according to any one of embodiments 9 to 11, wherein the longitudinal position of the enlarged opening between the third blade and the fourth blade is different from the longitudinal position of the enlarged opening between the first blade and the second blade. 13. The system according to Embodiment 8, wherein each of the third and fourth blades of the second guide element is perfectly flat or substantially flat from the proximal end to the distal end. 14. A third screw having a third screw head, the third screw head having a first side and a second side, the first side and the second side being opposite each other, the third screw, The system further comprises a third guide element configured to extend away from the third screw, wherein the third guide element is A fifth blade extending along a fifth longitudinal axis between a proximal and distal end, the fifth blade having a curved intermediate section between the proximal and distal end, the distal end of the fifth blade configured to engage with a first side of the third screw head, A sixth blade extending along a second longitudinal axis between a proximal and distal end, the sixth blade having a curved intermediate section between the proximal and distal end, the distal end of the sixth blade configured to engage with a second side of the third screw head, Equipped with, When the distal ends of the fifth and sixth blades engage with the third screw head, The inner surface of the fifth blade faces the inner surface of the sixth blade, spaced apart from it. The curved intermediate sections of the fifth and sixth blades form an enlarged opening with an increased spacing between the inner surfaces of the fifth and sixth blades relative to the spacing between the inner surfaces of the fifth and sixth blades at the proximal and distal ends of the intermediate section. The increased distance between the inner surfaces of the fifth and sixth blades is greater than the increased distance between the inner surfaces of the first and second blades, and as a result, the enlarged opening between the fifth and sixth blades is sized and configured to allow the passage of the second screw and the second guide element, and the passage of the first screw and the first guide element. The system according to any one of Embodiments 8 to 13. 15. A system for bone stabilization, It has multiple guiding elements, and each of the multiple guiding elements is A first blade having a proximal end and a distal end, wherein the first blade has a curved intermediate section between the proximal end and the distal end, A second blade having a proximal end and a distal end, the second blade having a curved intermediate section between the proximal end and the distal end, Equipped with, The distal ends of the first and second blades are configured to engage with bone screws, and when they engage with bone screws, The inner surface of the first blade faces the inner surface of the second blade, spaced apart from it. The curved intermediate sections of the first and second blades form an enlarged opening having an increased distance between the inner surfaces of the first and second blades relative to the distance between the inner surfaces of the first and second blades proximal and distal to the intermediate section. A system in which the first and second blades of a first guide element among a plurality of guide elements form an enlarged opening having different longitudinal positions, different spacings between the inner surface of the first blade and the inner surface of the second blade, and / or different orientations, compared to the enlarged opening formed by the first and second blades of a second guide element among a plurality of guide elements. 16. The system according to Embodiment 15, wherein the first and second blades of the third guide element among the plurality of guide elements form an enlarged opening having different longitudinal positions, different spacings between the inner surfaces of the first and second blades, and / or different orientations compared to the enlarged opening formed by the first and second blades of the second guide element among the plurality of guide elements, and compared to the enlarged opening formed by the first and second blades of the first guide element among the plurality of guide elements. 17. The system according to Embodiment 16, wherein the first and second blades of the fourth guide element among the plurality of guide elements form an enlarged opening having different longitudinal positions, different spacings between the inner surfaces of the first and second blades, and / or different orientations compared to the enlarged opening formed by the first and second blades of the third guide element among the plurality of guide elements, compared to the enlarged opening formed by the first and second blades of the second guide element among the plurality of guide elements, and compared to the enlarged opening formed by the first and second blades of the first guide element among the plurality of guide elements. 18. The system according to Embodiment 17, wherein the first and second blades of the fifth guide element among the plurality of guide elements form an enlarged opening having different longitudinal positions, different spacings between the inner surfaces of the first and second blades, and / or different orientations compared to the enlarged opening formed by the first and second blades of the fourth guide element among the plurality of guide elements, compared to the enlarged opening formed by the first and second blades of the third guide element among the plurality of guide elements, compared to the enlarged opening formed by the first and second blades of the second guide element among the plurality of guide elements, and compared to the enlarged opening formed by the first and second blades of the first guide element among the plurality of guide elements.

[0200] The systems, devices, and methods shown in Figures 6A to 6V. The embodiments disclosed herein relate to a system 600 for stabilizing a vertebral bone through a skin incision S. In any embodiment disclosed herein, any component, feature, or other detail of system 600 may have any of the components, features, or other details of any other system embodiment disclosed herein, or may be used in any combination with any of the components, features, or details of system 600 or method of use disclosed below, in accordance with any of the steps of any other method embodiment disclosed herein, including, but not limited to, any of the embodiments of system 200, 300, 400, and / or 500 or their methods of use described herein. Similarly, any component, feature, step, or other detail of any other system or method embodiment disclosed herein may have any of the components, features, steps, or other details of system 600 or its methods of use disclosed herein, in any combination with any of the components, features, or details of system.

[0201] In any embodiment disclosed herein, the system 600 may have guide elements having varying widths or spacings between the blades of the guide elements. The spacing between the blades may be sized and configured to allow other screws and towers or other guide elements or extensions to pass between their blades.

[0202] In some embodiments, the system 600 may include a first screw 612 which may include a first screw head 613, the first screw head 613 which includes a first side and a second side, the first side and the second side facing each other, and a first guide element 610 configured to extend away from the first screw head 613. In any embodiment disclosed herein, the first guide element 610 may include a first pair of blades 618 extending along a first longitudinal axis between the proximal end 610a and the distal end 610b of the first guide element 610. The first pair of blades 618 may include a transition portion 616 between the proximal end 610a and the distal end 610b of the first guide element 610, wherein the first spacing (also referred to herein as separation distance) between the inner surfaces of the first pair of blades 618 in the transition portion 616 increases such that the proximal spacing between the first pair of blades at the proximal end 610a of the first guide element 610 is greater than the distal spacing between the first pair of blades 618 at the distal portion 610b of the first guide element. The distal end 610b of the first pair of blades 618 may be configured to engage with or connect to the first screw head 613.

[0203] The system 600 may further include a second screw 622 which may contain a second screw head 623, the second screw head 623 having a first side and a second side, the first and second sides facing each other, and the second guide element 620 is configured to extend away from the second screw head 623. In some embodiments, the second guide element 620 may have a linear blade. In any embodiment disclosed herein, the second guide element 620 may include a second pair of blades 628 extending along a second longitudinal axis between the proximal end 620a and the distal end 620b of the second guide element 620. The second pair of blades 628 may include a transition portion 626 between the proximal end 620a and the distal end 620b of the second guide element 620, wherein the second spacing (also referred to herein as separation distance) between the inner surfaces of the second pair of blades 628 in the transition portion 626 increases such that the proximal spacing between the second pair of blades 628 at the proximal end 620a of the second guide element 620 is greater than the distal spacing between the second pair of blades 628 at the distal portion 620b of the second guide element 620. The distal end 620b of the second pair of blades 628 may be configured to engage with or connect to the second screw head 622.

[0204] In any embodiment disclosed herein, the second spacing between the second pair of blades 628 may be less than the first spacing between the first pair of blades 618. In this configuration, the second guide element 620 can advance through the first spacing between the first pair of blades 618 of the first guide element 610.

[0205] Some embodiments of the system 600 may further include a third screw 632 which may include a third screw head 633, the third screw head 633 which includes a first side and a second side, the first and second sides being opposite to each other, and the third guide element 630 is configured to be coupled to and extending away from the third screw head 633. In some embodiments, the third guide element 630 may have a linear blade. In any embodiment disclosed herein, the third guide element 630 may include a third pair of blades 638 extending along a third longitudinal axis between the proximal end 630a and the distal end 630b of the third guide element 630. The third pair of blades 638 may include a transition portion 636 between the proximal end 630a and the distal end 630b of the third guide element 630, wherein the third spacing (also referred to herein as separation distance) between the inner surfaces of the third pair of blades 638 in the transition portion 636 increases such that the proximal spacing between the third pair of blades 638 at the proximal end 630a of the third guide element 630 is greater than the distal spacing between the third pair of blades 638 at the distal portion 630b of the third guide element 630. The distal end 630b of the third pair of blades 638 may be configured to engage with or connect to the third screw head 632.

[0206] In any embodiment disclosed herein, the third spacing between the third pair of blades 638 may be less than the second spacing between the second pair of blades 624. Furthermore, the third spacing between the third pair of blades 638 may be smaller than the first spacing between the first pair of blades 614. In this configuration, the second guide element 620 and the third guide element 630 can be advanced through the first spacing between the first pair of blades in the first guide element 614.

[0207] In any embodiment, the first guide element 610, the second guide element 620, the third guide element 630, and / or the transition portion of any guide element may be angled outward away from the longitudinal centerline axis, or curved outward away from the longitudinal centerline axis, may be straight along the length of the transition portion, may be curved along the length of the transition portion, or may be curved in any other way. Furthermore, in any embodiment disclosed herein, each of the first pair of blades 618, the second pair of blades 624, the third pair of blades 638, and / or any blade of any guide element disclosed herein may have a substantially uniform cross-sectional thickness from the proximal end to the distal end. In any embodiment disclosed herein, the proximal portions of the first, second, and / or third pair of blades (i.e., from proximal end to proximal end of the transition portion) may be straight, planar, substantially straight, and / or substantially planar. Furthermore, the proximal blades of the first, second, and / or third pair of blades may be parallel or substantially parallel to each other.

[0208] In some embodiments, the third spacing between the inner surfaces of the third pair of blades 638 of the third guide element 630 can be 25% (or about 25%), or 15% (or about 15%) to 35% (or about 35%) or more smaller than the second spacing between the inner surfaces of the second pair of blades 624 of the second guide element 620. In any embodiment disclosed herein, the third spacing of the third guide element 630 can be smaller than the second spacing of the second guide element 620 by an amount greater than the thickness of each blade of the third pair of blades 638. Furthermore, the second spacing between the inner surfaces of the second pair of blades 628 of the second guide element 620 may be 25% (or about 25%), or 15% (or about 15%) to 35% (or about 35%) or more smaller than the first spacing between the inner surfaces of the first pair of blades 614 of the first guide element 610. In any embodiment disclosed herein, the second spacing of the second guide elements 620 can be smaller than the first spacing of the first guide elements 620 by an amount greater than the thickness of each blade of the second pair of blades 628.

[0209] In any embodiment disclosed herein, the guide element may have any of a range of lengths suitable for a range of different sizes of biomolecules, thereby enabling a surgeon to select one or more desired lengths of the blade and the position of the enlarged opening, for example, after measuring the depth of the tissue. 【021...

Claims

1. A system for stabilizing the vertebrae through a skin incision, wherein the system is The first tower, A distal portion, the distal portion having a channel extending along the axial centerline of the distal portion of the first tower, A proximal portion extending in a first direction at a non-zero acute angle away from the distal portion of the first tower, An opening positioned between the distal portion and the proximal portion, The first tower is equipped with, A second tower is configured to be positioned within the opening of the first tower, wherein the second tower is A distal portion, the distal portion having a channel extending along the distal portion of the second tower, When the system is assembled in an operational state, the proximal portion extends in the first direction at a non-zero acute angle away from the distal portion of the second tower, A second tower equipped with, Equipped with, A system in which an opening in the first tower is configured to receive the second tower within it.

2. The system according to claim 1, further comprising a cover, the cover being independently connectable to the first tower and the second tower.

3. The system according to claim 2, wherein the cover is configured to separately close at least a portion of the channels of the first tower and the channels of the second tower.

4. The system according to claim 2, wherein the first tower and the second tower further comprise axial grooves configured to receive the protrusions of the cover.

5. The system according to any one of claims 1 to 4, wherein the proximal portion of the first tower is provided with a flat portion, and the proximal portion of the second tower is provided with a flat portion.

6. The system according to claim 5, wherein the flat portion of the first tower is provided with a slot extending from the proximal end of the flat portion of the first tower toward the distal end of the flat portion of the first tower, and the flat portion of the second tower is provided with a slot extending from the proximal end of the flat portion of the second tower toward the distal end of the flat portion of the second tower.

7. The system according to claim 6, wherein the slots in the flat portion of the first tower and the slots in the flat portion of the second tower are configured to engage with a robotic arm.

8. The system according to claim 5, wherein the flat portions of the first tower are arranged along an axial centerline extending at a non-zero acute angle away from the proximal portion of the first tower, and the flat portions of the second tower are arranged along an axial centerline extending at a non-zero acute angle away from the proximal portion of the second tower.

9. The system according to any one of claims 1 to 4, wherein the first tower further comprises a window at the distal end of the distal portion of the first tower, and the second tower further comprises a window at the distal end of the distal portion of the second tower.

10. The system according to claim 9, wherein the windows of the first tower and the windows of the second tower are arranged along a common plane.

11. The system according to claim 9, wherein the windows of the first tower and the windows of the second tower are configured to receive connecting elements.

12. The system according to any one of claims 1 to 4, wherein the distal portion of the first tower and the distal portion of the second tower are configured to be removably coupled to a first screw and a second screw, respectively, which are embedded in adjacent vertebrae.

13. The system according to any one of claims 1 to 4, wherein the first tower can be pivoted relative to the second tower.

14. The system according to any one of claims 1 to 4, wherein, in the operable state, the proximal portion of the second tower is positioned between the proximal and distal portions of the first tower.

15. The system according to any one of claims 1 to 4, wherein the distal portion of the first tower and the distal portion of the second tower are curved, and the proximal portion of the first tower and the proximal portion of the second tower are flat.

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