Systems and methods for pedicle screw stabilization of spinal vertebrae

Disclosed herein are embodiments of a system and embodiments of a method for stabilizing spinal vertebrae through a skin incision. In some embodiments, the system or method can include a first screw having a first screw head, a second screw having a second screw head, and a third screw having a third screw head, a first tower having a distal portion, a proximal portion, and a bend between the distal portion and the proximal portion, a second tower having a distal portion and a proximal portion, the second tower configured to be removably coupled with the second screw at a distal end of the second tower, and a third tower having a distal portion, a proximal portion, and a bend between the distal portion and the proximal portion.

BACKGROUND

Field

Embodiments of the present disclosure relate to devices, systems, and methods for treating the spine, including without limitation devices, systems, and methods for stabilizing adjoining vertebrae in at least the cervical, thoracic, and lumbosacral spine.

Description of the Related Art

While some lower back conditions can be ameliorated with non-surgical approaches, spinal fusion is recommended for certain conditions when non-surgical approaches fail. Non-surgical approaches include medications, physical therapy, chiropractic treatment, traction, epidural steroid injections, facet blocks or rhizotomy, weight loss, smoking cession, and acupuncture. Conditions that commonly serve as indications for spinal fusion or stabilization surgery can be divided generally into three categories: (i) trauma induced, (ii) curvature, and (iii) degenerative.

Trauma induced conditions include fractures and ligamentous injuries. Fractures typically result from an unfortunate incident involving an extraneous force or fall but may also arise from pathologic conditions, such as cancer or osteoporosis. Fractures are often compressive in nature and typically lead to a pathological curving of the spine resulting in a loss of the natural lordotic curvature in the lumbar and cervical spine, known as kyphosis. Fractures of the spine also occur with translational or rotational forces perpendicular to the axis of the spine. These forces result in fractures of the facet or pars interarticularis (pars). If the external forces are large enough, vertebrae can collapse resulting in a burst fracture that can injure all three (3) columns of the vertebrae (anterior, middle, and posterior columns). Many traumatic injuries can heal without surgery, but unstable injuries that pose a risk for neurologic injury and/or pain require stabilization through a procedure such as fusion.

A condition called spondylolisthesis characterized by slippage of the spine bones or vertebrae relative to one another can result from fractures of the pars interarticularis (pars fracture) known as spondylolysis. Spondylolisthesis can also develop from malformation of the facet joints by degenerative arthritis as well as congenital malformation and pathologic conditions such as tumors. If the pars on both sides are fractured, then the spinous process and lamina are essentially completely disconnected from the pedicle and vertebral body. This large fragment is called the Gill body. Pars fractures are actually common in people of all ages (often acquired in the teenage years). While, many of these patients are mildly symptomatic and do not require surgery, those with progressive symptoms may require surgical decompression with or without fusion. Spondylolisthesis results in misalignment of the spine and increases the risk of a nerve becoming entrapped. Nerves travel within the spinal canal bounded by the vertebrae and their roots protrude from the curved openings in the sides of the vertebrae called foramina (singular is foramen). These spinal nerves are suspected to be the source of back and radicular pain when they become entrapped or when the nerve endings become irritated by irregular or abrasive motion around a disc, bone, or joint. Spondylolisthesis can also aggravate or be accompanied by degeneration of disc or facet joint which can lead to axial back pain.

The normal curvature of the lumbar and cervical spine is lordosis, where the posterior aspect of these spinal levels forms a concave curve. The thoracic spine normally has a kyphotic or convex curve. Curvature conditions include straightening of the natural curvature as well as abnormal lordosis, abnormal kyphosis or lateral/rotational bending called scoliosis. Curvature conditions can occur idiopathically during adolescence, e.g., adolescent idiopathic scoliosis, or develop as a secondary problem in situations where spinal muscle activation is abnormal such as cerebral palsy, spina bifida, or tethered cord syndrome. Abnormal spinal curvature is common in spinal degeneration when the discs and joints degenerate asymmetrically leading to a progressive curvature (scoliosis, kyphosis, or lordosis) as the biomechanics of the spine are disrupted. Curvature conditions also occur after trauma with compression or burst fractures or with ligamentous injury. Additionally, curvature conditions can occur iatrogenically after previous spinal surgery where the anatomy and biomechanics of the spine have been altered. Such situations include the removal of the posterior tension band after laminectomy as well as the alteration of physiologic movement after spinal fusion leading to adjacent level compensation and degeneration. Curvature conditions lead to abnormal biomechanical stress on the discs and facet joints accompanied by compensatory measures such as facet or ligamentous hypertrophy. Patients can develop both axial back pain and radicular pain. In patients who have failed conservative therapy and bracing, surgery can be effective. Surgery in these conditions includes decompression of nerve or spinal cord compression as well as fusion or stabilization. Curvature can be corrected through surgery, and fusion prevents further curvature from developing.

Degenerative conditions include spinal arthritis and recurrent disc herniation. Spinal arthritis is the most common indication for fusion and may exist in the form of severe disc degeneration (also called Degenerative Disc Disease, DDD) or facet disease. Degenerative arthritis can also be a cause of spondylolisthesis in addition to traumatic fractures discussed above. Degenerative conditions are generally accompanied by nerve compression causing radicular pain in the distribution of the nerve's receptive field, which usually correlates with and is manifested in arm or leg pain. Pure nerve compression syndromes such as herniated nucleus pulposus (herniated discs) or foraminal stenosis (narrowing of the side foramina canals through which the nerves pass) can often be treated with decompression without fusion. Pure disc degeneration syndromes can be treated with fusion without decompression of the nerves. However, most commonly disc degeneration occurs in combination with nerve compression causing both axial back pain and radicular limb pain. In these circumstances, fusion surgery is combined with nerve decompression surgery.

Fusion functions to eliminate motion in the disc space and facet joints between adjacent vertebrae. The vertebrae provide the rigid structural framework of the spine and the fibrocartilaginous disc space acts as a cushion or shock-absorber. Degradation of the disc space can distort alignment and alter the biomechanical cushion that the disc affords the adjacent vertebrae. This degradation alters the forces impacted upon the vertebrae and results in axial back pain. Fusion is designed to eliminate movement between adjacent vertebrae by either forming a solid bridge of bone across the disk space and/or creating new bone formation in the posterolateral space to provide stabilization, rigidity, and strength. Sometimes fusion involves a bone graft taken from another location in the body (e.g., autograft from the iliac crest in the pelvis) or from an external source, e.g., allograft. Physicians commonly refer to the level of a fusion. A single level fusion involves stabilizing the two vertebral bones adjacent to a diseased disc. A two-level fusion involves stabilizing three adjacent vertebral bones spanning two problematic disc spaces. Each vertebra makes contacts (joints) with adjacent vertebrae at three points, the paired facet joints located posteriorly and the intervertebral disc located anteriorly. Thus, lumbar fusion can be directed either at the posterior facet joints or at the anterior interbody/disc space or both. When an anterior interbody fusion is performed in combination with posterior fusion, the procedure is termed 360° fusion. One commonly used technique of posterolateral fusion is pedicle screw fusion where screws are directed into the pedicle portions and the bodies of adjacent vertebrae and then rods are connected to the screws across the disc spaces. The screws and rods hold the adjacent vertebrae motionless relative to one another and allow the bone graft that is placed either in the interbody (disc) space or in the posterolateral space to grow into solid bone. Conventional pedicle screws and rods are metal, typically titanium (Ti) alloy but have been made from stainless steel, cobalt chrome, and molybdenum rhenium as well. Recently rods have been made from a minimally flexible polymer called polyetheretherketone (PEEK). Other metals have been used and can also be adopted. These can include, for example, cobalt, molybdenum, and other metallic as well as nonmetal polymers.

A newer lumbar pedicle screw technique involves placing screws from a midline incision and placing screws superiorly and laterally instead of the typical trajectory of starting laterally and aiming medically through the pedicle into the vertebral body. This technique has been named Cortical Bone Trajectory (CBT) because the trajectory of the screw transverses more cortical bone in contrast to cancellous bone. Cortical bone is typically harder and thus provides greater pullout strength. Thus cortical bone trajectory allows smaller and shorter screws with a single midline incision instead of bilateral Wiltse style incisions. The issue with CBT screw trajectory is that the superior screw in a lumbar fusion such as L4 trajectory in a L4, L5 TLIF surgery, has a trajectory that is aimed more superiorly and laterally rather than a medical trajectory. The inferior screw can have a parallel trajectory or have a more straight-in trajectory in the sagittal plane (rather than superior direction). This configuration causes a natural crossing of the superior screw with the inferior screw in that the superior screw is aimed superiorly so a minimally invasive spinal (MIS) screw attached to a tower has the tower pointing inferiorly because the screw is directed superiorly. While the inferior screw is directed is a less superior trajectory so the towers attached to these two screws are bound to interfere. Furthermore since the incision is midline and the screws are directed from medial to lateral direction, then the screws from ipsilateral and contralateral sides also are bound to intersect. Thus cortical bone trajectory is a technique that would benefit from towers attached to screws that did not interfere with each other due to the fact that they have interfering trajectories.

Interbody fusion involves placing one or more spacers (typically pre-loaded with bone graft material) within the interbody (disc) space between bony vertebral bodies after the degenerated disc has been cleaned out and removed. Spacers are made from bone grafts, titanium, carbon fiber, or polymers such as PEEK. Interbody fusion can be performed through several approaches including: an anterior approach (anterior lumbar interbody fusion, ALIF), a posterior approach (posterior lumber interbody fusion, PLIF, or transforaminal lumbar interbody fusion, TLIF), or a lateral approach (direct lateral interbody fusion, DLIF™ Medtronic, or extreme lateral interbody fusion, XLIF™—Nuvasive). The aim of these approaches is to remove the degenerated disc and replace the disc with material that induces bony fusion. Alternatively, the disc can be replaced with an artificial joint/disc (discussed below). Each of these interbody approaches has advantages and disadvantages. Anterior procedures allow a very large spacer with large degree of lordosis but require a retroperitoneal dissection and risk injury to the large blood vessels anterior to the lumbar vertebrae. In addition, injury to the nerve plexus anterior to the vertebrae can result in sexual dysfunction. The lateral approach also allows a very large spacer and some lordosisbut is limited to the upper and mid lumbar levels (rostral to L5, S1) because of obstruction by the iliac crest. The posterior interbody approach is more time consuming and typically requires more muscle dissection and retraction. However, the posterior approach allows the placement of the interbody graft, posterior pedicle screw fusion, and decompression of nerves all to occur through the posterior incision(s).

Although anterior and lateral approaches can be performed stand-alone (without posterior instrumentation), many surgeons will back-up or supplement anterior or lateral interbody fusions by placing pedicle screws posteriorly after the interbody cage or graft has been placed. This 360° fusion limits movement more than just an isolated anterior or posterior fusion, and fusion rates are increased. However, in ALIF and lateral interbody (DLIF™, XLIF™) cases, two sets of incisions are required for a 360° fusion.

The posterior approaches (TLIF and PLIF) allow an interbody fusion, pedicle screw fusion, and neural decompression to be done all through the same posterior incision(s). In the TLIF, a single large interbody spacer is inserted on the side ipsilateral to the patient's symptomatic side after neural decompression is completed. If both sides are symptomatic then decompression is required on both sides. A PLIF is performed by placing two interbody spacers, one on each side. Posterior procedures may be done according to: (i) an invasive open procedure in which a large incision and/or several incisions are made, (ii) a percutaneous approach in which small incisions and/or few incisions are made, and potentially (iii) an endoscopic approach in which small incisions are made and all tools and devices are inserted through portals with visualization provided on an external monitor.

As an alternative to fusion, recent advances in interbody stabilization have resulted in the development of artificial disc technology. Artificial discs replace the degenerated discs and allow continued motion at the joint. Both cervical and lumbar artificial discs have been developed. Additionally, dynamic stabilization techniques have been developed for the posterior spine. These posterior techniques utilize pedicle screws and a dynamic rod. Typically the dynamic rod has a mechanism to bend under certain loads or forces, thereby absorbing some stress and strain that is applied to the spine. The advantage of dynamic stabilization is that motion is preserved in the spine. However, the durability of these systems may be an issue. In fusions, the bone graft (interbody or posterolateral) eventually fuses the vertebrae eliminating the need for the spinal instrumentation (screws and rods). However in dynamic stabilization, fusion does not occur, so the screws and dynamic rods will always be subjected to the strain and forces of the spine. Over time, the possibility of loosening of the pedicle screws or mechanical failure may increase. Sometimes the use of a slightly flexible rod such as a rod made of PEEK may actually increase fusion by reducing stress shielding. Stress shielding occurs when rigid fusion constructs shield the vertebral bone in contact with the bone graft from the stresses required to form and remodel bone.

Posterior lumber stabilization (fusion and dynamic stabilization) techniques have evolved into minimally invasive approaches because such minimized exposures reduce patient morbidity and facilitate patients' recovery to function. Blood loss and hospital stays are shorter. The process of performing a minimally invasive pedicle screw fusion is the same as that for dynamic stabilization and involves two basic parts. First, screws are placed percutaneously through the pedicle into the vertebral body. For minimally invasive systems, cannulated screws are placed percutaneously over a fluoroscopically (an X-ray that can be seen on a video screen) guided guidance element. Recent advances also allow screws, either cannulated or noncannulated, to be placed using intraoperative navigation, using robotic guidance, or using virtual reality guidance. Generally, two screws are used on each vertebral body being fused, one on a right side and the other on a left side. A single level fusion involves connecting the vertebral bodies that are next to the disc level that is being fused. For instance, a L5, S1 fusion requires screws to be placed at L5 and S1, usually bilaterally, in order to immobilize the L5, S1 disc. The second part of the process involves connecting the screws with a rod and locking the rod and screws 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 that for fusion. For example, a rod-like device (flexible connector), like a rod, fits within the screw heads, but may also include an element (a shock absorber, a spring, etc.) that allows some motion. The variations between different minimally invasive systems mostly arise in the method of placing the rod and locking the rod with the screws through a minimal incision.

Before the intervertebral body spacer is inserted, the damaged or degenerated disc within the disc space must be removed. In the TLIF approach, the disc space is accessed through a facetectomy in which the foramen around the nerve roots is opened with a bone-cutting tool such as an osteotome or a high-speed drill. In the PLIF approach, laminectomies or laminotomies are performed to access the disc space. Both TLIF and PLIF allow for decompression of the spinal thecal sac and the nerve roots; however, the facetectomy in a TLIF allows the maximum decompression of the exiting nerve root on that side. With gentle retraction of the thecal sac, the disc space is easily accessed. Then the instruments used for clearing out the degenerated disc may be inserted into the disc space to complete the discectomy.

Following removal of the disc, the surgeon should prepare the bony surfaces, known as the end plates, of the vertebral bodies on each side of the disc that was removed. Peeling off the end plate with a tool such as a curette induces bleeding which stimulates healing and assimilation of the bone graft to be inserted into the interbody space. The spacer or cage that is to be inserted is typically constructed of bone, titanium, carbon fiber, or polymers such as PEEK. The spacer is usually hollow or at least porous to accommodate bone graft material therein. Bone inducing protein such as bone morphogenetic protein (BMP) is also commonly placed within the spacer. After placing the spacer and bone graft, the rods may be inserted into the pedicle screws and the screws can be tightened to lock the rods in place.

Pedicle screw fusions such as the TLIF can be done open through a single large incision or through a minimally invasive (MIS) approach in which the incision size(s) are smaller, and less tissue is damaged or injured. MIS TLIF typically uses percutaneous pedicle screws where each screw is placed through a small incision just about the side of the diameter of a single screw, screw head, or the largest screw insertion tool. Typically, the placement of the percutaneous screws is straightforward. This is because screws are long and thin and are screwed through the tissue into the bone either directly or over a guidewire that is placed through either fluoroscopic guidance or using stereotactic navigation sometimes with the aid of a surgical robotic. Whereas in the open approach the screws are placed using visually identified anatomic landmarks and fluoroscopic guidance, though navigation and robotic guidance can help in open cases as well. Because percutaneous pedicle screws are placed through small incisions that are barely large enough to fit the screw or screw insertion tools, virtually no visual landmarks are available. There are miniopen approaches where visual landmarks for placing pedicle screws can be identified through tiny incisions using either a microscope or endoscope through either a small tubular retractor or endoscope. The key is that once the pedicle screw tract is located and the guidewire is placed into the pedicle screw tract, then placing a percutaneous pedicle screw over the guidewire is relatively easy. Also stereotactic navigation and robotic guidance has also made placement of pedicle screws relatively easy.

In most of the minimally invasive surgery (MIS) systems used today, a guidance element, such as a wire or guidewire, is placed percutaneously under fluoroscopic guidance through the pedicle. Recent advances also allow screws, either cannulated or noncannulated, to be placed using intraoperative navigation, using robotic guidance, intraoperative CT, or using virtual reality guidance. These methods also allow accurate placement of pedicle screws directly without guidewire and without cannulation. If a guidewire system is used, percutaneous cannulated drills and screw taps are inserted over the guidance element/wire to prepare the tract through the pedicle and vertebral body for pedicle screw insertion. Dilating tubes and a guidance tube or a retractor system can often be used to dilate and hold open the path around the guidance element through skin and muscle to reduce injury to muscle and tissue when pedicle screws and insertion tools are inserted. Pedicle screws are inserted over the guidance elements either with or without passage through a guidance tube/retractor. Again, because of the development and wide spread use of intraoperative navigation to guide pedicle screw placement, some pedicle screws can be placed without the use of predrilling a hole or the use of a guidewire. These systems use intraoperative navigation to directly place the pedicle screw through the tissue into bone without predrilling a hole or tapping the hole. Additionally robotic arms can now be used to also aid in the accurate placement of pedicle screws in addition and often combination with navigation systems.

In MIS pedicle screw fusion, after the pedicle screw has been inserted, there are still critical steps in connecting the screw heads and locking adjacent screws using a rod and locking cap. The insertion of rods that connect the screw heads and locking caps to lock the rod inside the screw heads are currently some of the most difficult steps while using a MIS approach through a minimal incision. In order to place the rod and locking assembly into the screw heads, each screw head is associated with blades or towers that extend upwards from the screwhead through the skin incision. The tower has to accommodate the rod and locking assemblies so it is typically the same size or larger than the maximum diameter of the screw head. Once the towers attached to the screws are in place, the rod is then inserted through one of a variety of methods. The leading MIS system is Sextant™ by Medtronic. In this system, the rod is placed by forming a pendulum like mechanism. The two or three towers (for one or two-level fusion, respectively) are coupled together to align the towers, and the rod is swung around through a separate incision superior or inferior to the towers in a pendulum fashion. Once the rod is swung in place, locking caps are placed through the towers and tightened. Alternatively, most of the existing systems insert the rod through one of the towers and then turn the rod approximately 90° to capture the other screws in the other towers. Inserting the rod through the screw heads in a minimally invasive system is done blindly, e.g., without direct visualization of the screw head. Thus, this process is sometimes tedious and frustrating.

The Sextant™ system and other existing systems that use towers are hindered by both the number of incisions required. The use of 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 an additional incision for the rod, equaling six incisions (three on each side) for a single level fusion and eight incisions for a two level fusion. The other existing tower systems that use the direct rod insert and turn mechanism still require one incision for each screw and each incision has to be larger than the size of a tower through which the screws are inserted. Typically, each incision is at least 15 mm in length. When the sum of the lengths of all incisions on both sides are totaled, the total length of the current leading minimally invasive systems often are longer than the single midline incision of a traditional “open” approach for a single or two level pedicle screw fusion.

Furthermore none of the current MIS pedicle screw systems has been designed to take advantage of the lumbar lordosis that is typically present in most patients. About 80% of lumbar pedicle screw fusions are performed at the lowest two levels L4 to L5 and L5 to S1. These lowest lumbar levels also typically exhibit the strongest lumbar lordosis such that pedicle screw tracts through L4, L5, S1 and even L3 often intersect near a single point often near the skin similar to spokes on a bicycle tire. For most pedicle screw systems, this lordotic curvature is a hindrance in which the towers of the pedicle screws all intersect and cross. Crossing of the towers make it difficult for these MIS screw systems to allow a rod to be placed through the channels of the towers.

U.S. Pat. No. 7,306,603 entitled “Device and method for percutaneous placement of lumbar pedicle screws and connecting rods” by Frank H. Boehm, Jr., et al. and assigned to Innovative Spinal Technologies (Mansfield, MA), the entirety of which is hereby incorporated by reference, discloses a system of connecting a rod to the pedicle screws using a pin and recesses within the screw heads. According to this system the rod can pivot about a longitudinal axis of the pin between a first position in which the rod is parallel to the longitudinal axis of the screw (e.g., vertically oriented) and a second position in which the rod is transverse to that axis in order to bridge screws on adjacent vertebrae. The '603 Patent teaches various guide systems (seeFIGS.5and6), rod holder systems (seeFIGS.8,9,10, and11), and a rod guide system (seeFIG.12) but does not include a sleek, detachable system among them. Rather, the systems illustrated are tower-like with rather bulky dilators (80 and 86 inFIGS.6and8), sheaths (81 inFIG.6), and/or outer housing (120 inFIGS.11and12). U.S. Publication No. 2008/0140075 entitled “Press-On Pedicle Screw Assembly” by Michael D. Ensign and assigned to Alpinespine, LLC (American Fork, Utah), the entirety of which is hereby incorporated by reference, discloses attaching the rod to screw heads indirectly via a tulip assembly. The tulip assembly has a housing with an inner diameter smaller than an inner diameter of the screw head such that it is easily pressed into position upon the screw head. The rod is then placed by attaching directly to the tulip assembly after connecting the assembly to the screw head. The publication mentions using a Kirschner guidance element (or K-guidance element) for inserting both the pedicle screws and the tulip member (see [0030], [0032], and [0045]) but does not disclose how the rods are guided into position.

U.S. Publication No. 2008/0097457 entitled “Pedicle screw systems and methods of assembling/installing the same” by David R. Warnick and unassigned, the entirety of which is hereby incorporated by reference, like the '075 Publication, also discloses using a tulip assembly as an intervening means to join a rod to the screws. In this system, rather than a press-on locking mechanism, the structure is tightened by rotating an inner member and outer housing of the tulip assembly relative to one another.

U.S. Pat. No. 7,179,261 entitled “Percutaneous access devices and bone anchor assemblies” by Christopher W. Sicvol, et al. and assigned to Depuy Spine, Inc., the entirety of which is hereby incorporated by reference, describes one of the several tower systems for placement of pedicle screws percutaneously. The patent describes a situation where the angle of the screws intersect, and the towers may interfere with each other. This situation is rather typical in the lordotic lumbar spine, especially the lumbo-sacral (L5, S1) junction. In order to solve this problem, they describe cutouts in the tubes so that two tubes can intersect. Given that the angles of the vertebrae are variable from patient to patient and the depth of the vertebrae from the skin is also highly variable, the variations on the cutouts would have to be numerous. Additionally, when two tubes intersect at the cutout as shown in FIG. 22B in the '261 Patent, the edges of the cutout of one tube interferes or blocks off the lumen of the other tube, and vice versa. This occurs because the muscle and tissue surrounding the tubes will push the tubes together at the section of the cutouts thereby significantly reducing the lumen through which the rod and other elements are inserted. The only way to avoid this interference or blockage of the lumens is to keep the tubes separate that would necessitate a larger incision and would eliminate the need for cutouts in the first place. Additionally a 2 or 3 level fusion requiring 3 or 4 screws that may be intersecting would be problematic if the towers on the screws were intersecting.

SUMMARY OF SOME EXEMPLIFYING EMBODIMENTS

Some embodiments described in this application are directed to systems, devices and/or methods for bone stabilization, such as for stabilizing the spine. In some embodiments, one or more guiding elements may be provided, which may also be referred to herein as guidance elements, guide elements, towers, or extensions or other terms as later described. Guiding elements may be connectable with, attachable to, and/or engageable with bone screws, such as pedicle screws. These guiding elements may be utilized in some embodiments to deliver a connecting member, such as a rod, to bone screws implanted within a patient's vertebrae. Additional systems, devices and methods are described herein, including but not limited to rod insertion devices and guidance tools for drills. The systems, methods and devices of this disclosure each have several innovative aspects, implementations, or aspects, no single one of which is solely responsible for the desirable attributes disclosed herein.

Some embodiments of a system for bone stabilization disclosed herein can have a first guiding element comprising an elongate body having a first longitudinal axis, a proximal end and a distal end, the distal end configured to engage with a first bone screw, a second guiding element comprising an elongate body having a second longitudinal axis, a proximal end and a distal end, the distal end configured to engage with a second bone screw, and an opening provided at an intermediate portion of the first guiding element when in use. In some embodiments, the opening can be sized and configured to allow for passage of the second guiding element therethrough such that the second longitudinal axis is at an angle relative to the first longitudinal axis, wherein the opening is sized and configured to limit movement and/or rotation of the second guiding element along the first longitudinal axis relative to the first guiding element.

Disclosed herein are embodiments of a system for stabilizing spinal vertebrae through a skin incision. In some embodiments, the system can include a first screw having a first screw head, a second screw having a second screw head, and a third screw having a third screw head, a first tower having a distal portion, a proximal portion, and a bend between the distal portion and the proximal portion, a second tower having a distal portion and a proximal portion, the second tower configured to be removably coupled with the second screw at a distal end of the second tower, and a third tower having a distal portion, a proximal portion, and a bend between the distal portion and the proximal portion.

Any embodiments of the devices, systems, and methods disclosed herein can include, in additional embodiments, 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 embodiments of the devices, systems, and methods disclosed herein: wherein the first tower can be configured to be removably coupled with the first screw at a distal end of the first tower; wherein the third tower can be configured to be removably coupled with the third screw at a distal end of the third tower; wherein the first tower is configured to removably couple with the first screw such that, when the first tower is coupled with the first screw, an axial centerline of the distal portion of the first tower is approximately collinear with an axial centerline of the first screw; wherein the second tower is configured to removably couple with the second screw such that, when the second tower is coupled with the second screw, an axial centerline of the distal portion of the second tower is approximately collinear with an axial centerline of the second screw; wherein the third tower is configured to removably couple with the third screw such that, when the third tower is coupled with the third screw, an axial centerline of the distal portion of the third tower is approximately collinear with an axial centerline of the third screw; wherein the proximal portion of the first tower extends at an acute, nonzero angle away from the axial centerline of the distal portion of the first tower; wherein the proximal portion of the third tower extends at an acute, nonzero angle away from the axial centerline of the distal portion of the third tower; wherein, in an operable state, the first, second, and third towers are configured to intersect one another; and/or wherein the proximal portions of one or more of the towers (for example and without limitation, the first and third towers or extensions) are configured to be compatible with graspers, coupling mechanisms, and other components of surgical robotic systems.

Also disclosed herein are embodiments of a system for stabilizing spinal vertebrae through a skin incision. In some embodiments, the system can include a first screw having a first screw head, a second screw having a second screw head, and 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 configured to be removably coupled with the second screw at a distal end of the second tower, and a third tower having a distal portion and a proximal portion.

Any embodiments of the devices, systems, and methods disclosed herein can include, in additional embodiments, 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 embodiments of the devices, systems, and methods disclosed herein: wherein the first tower can be configured to be removably coupled with the first screw at a distal end of the first tower; wherein the third tower can be configured to be removably coupled with the third screw at a distal end of the third tower; wherein the first tower is configured to removably couple with the first screw such that, when the first tower is coupled with the first screw, an axial centerline of the distal portion of the first tower is approximately collinear with an axial centerline of the first screw; wherein the second tower is configured to removably couple with the second screw such that, when the second tower is coupled with the second screw, an axial centerline of the distal portion of the second tower is approximately collinear with an axial centerline of the second screw; wherein the third tower is configured to removably couple with the third screw such that, when the third tower is coupled with the third screw, an axial centerline of the distal portion of the third tower is approximately collinear with an axial centerline of the third screw; wherein the proximal portion of the first tower extends at an acute, nonzero angle away from the axial centerline of the distal portion of the first tower; wherein the proximal portion of the third tower extends at an acute, nonzero angle away from the axial centerline of the distal portion of the third tower; wherein, in an operable state, the proximal portion of the first tower extends away from the second tower in a first direction; and/or wherein, in an operable state, the proximal portion of the third tower also extends away from the second tower in the first direction.

Also disclosed herein are embodiments of a method of stabilizing spinal vertebrae. In some embodiments, the method can include implanting a first screw that is coupled with a first tower through an incision into a first vertebra, advancing a second tower that is coupled with a second screw through an opening formed in the first tower and implanting the second screw into a second vertebra, advancing a third tower that is coupled with a third screw through the opening formed in the first tower and implanting the third screw into a third vertebra, and moving a proximal portion of the first tower toward a proximal portion of the third tower to move the first vertebra from a first position relative to the third vertebra to a second position relative to the third vertebra.

Also disclosed herein are embodiments of a method of stabilizing spinal vertebrae. In some embodiments, the method can include implanting a first screw that is coupled with a first extension through a single incision into a first vertebra, the first extension having a proximal portion and a distal portion, advancing a second extension that is coupled with a second screw through the single incision and through a first opening formed in the first extension so that an axial centerline of at least a distal portion of the second extension is at an acute angle relative to an axial centerline of at least the distal portion of the first extension, implanting the second screw into a second vertebra, advancing a third extension that is coupled with a third screw through the single incision and through the first opening formed in the first extension so that an axial centerline of at least a distal portion of the third extension is at an acute angle relative to the axial centerline of at least the distal portion of the first extension and is at an acute angle relative to the axial centerline of at least the distal portion of the second extension, and implanting the third screw into a second vertebra.

Any embodiments of the devices, systems, and methods disclosed herein can include, in additional embodiments, 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 embodiments of the devices, systems, and methods disclosed herein: wherein, in an operable state, the first, second, and third towers are configured to intersect at or adjacent to a skin level of a patient; wherein, in an operable state, the first, second, and third towers are configured to intersect in an implanted state at or adjacent to a skin level of a patient such that a distance from the skin level to a proximal most end of the distal portion of the first tower is less than or equal to 10% of a length of the distal portion of the first tower and a distance from the skin level to a proximal most end of the distal portion of the third tower is less than or equal to 10% of a length of the distal portion of the third tower; wherein the first tower has an opening therein sized and configured to receive the second tower and the third tower therein such that, in an operable state, an outer wall of a portion of the first tower surrounds an outer surface of a portion of the second and third towers; wherein the opening extends at least through a proximal end of the distal portion of the first tower; wherein the opening extends along the first tower to an edge that is adjacent to a proximal end of the distal portion of the first tower; wherein the proximal portion of the first tower is configured such that, in an operable state of the system, the proximal portion of the first tower also extends at an acute, nonzero angle away from the axial centerline of the proximal portion of the second tower so that the proximal portion of the first tower forms an acute angle relative to the proximal portion of the second tower; wherein the distal portion of the first tower is configured such that, in an operable state of the system, the distal portion of the first tower extends at an acute, nonzero angle away from the axial centerline of the distal portion of the second tower so that the distal portion of the first tower forms an acute angle relative to the distal portion of the second tower; wherein the proximal portion of the third tower is configured such that, in an operable state of the system, the proximal portion of the third tower also extends at an acute, nonzero angle away from the axial centerline of the proximal portion of the second tower so that the proximal portion of the third tower forms an acute angle relative to the proximal portion of the second tower; wherein the distal portion of the third tower is configured such that, in an operable state of the system, the distal portion of the third tower extends at an acute, nonzero angle away from the axial centerline of the distal portion of the second tower so that the distal portion of the third tower forms an acute angle relative to the distal portion of the second tower; and/or wherein the distal portion of the first tower and/or the third tower has a curved cross-sectional profile and the proximal portion of the first tower and/or the third tower has a flat or rectangular cross-sectional profile.

Any embodiments of the devices, systems, and methods disclosed herein can include, in additional embodiments, 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 embodiments of the devices, systems, and methods disclosed herein: wherein the first tower is sized and configured such that, in an implanted state, the proximal portion of the first tower extends away from a skin incision in a first direction and the proximal portion of the third tower also extends away from the skin incision in the first direction; wherein, in an operable state, the proximal portion of the third tower is positioned between the proximal portion of the first and second towers; wherein the first tower is sized and configured such that, in an operable state, the proximal portion of the first tower extends away from a skin incision in a first direction and the proximal portion of the third tower also extends away from the skin incision in the first direction; wherein the distal portion of the first tower extends away from the first screw to a height just below the skin incision, or to a height level with the skin of a patient, when the first screw is fully implanted in a first vertebra; wherein the proximal portion of the first tower is configured to be grasped by a surgeon to enable a surgeon to exert a counter-torque force on the first tower about at least the axial centerline of the distal portion of the first tower; wherein, in an operable state, the proximal portion of the third tower is configured to be grasped by a surgeon to enable a surgeon to exert a rotational force on the third tower about at least the axial centerline of the distal portion of the third tower; wherein, in an operable state, the system is configured such that moving the proximal portion of the first tower toward the proximal portion of the third tower will cause a compressive force on at least a first vertebra that the first screw is implanted in relative to a third vertebra that the third screw is implanted in; wherein the first tower and the third tower are sized and configured such that only the proximal portions of the first and third towers are outside of a skin incision when the first screw is implanted in a first vertebra; wherein the system is configured such that the first, second, and third screws are implanted through the same skin incision; wherein the proximal portion of the first tower has a length that is approximately the same as a length of the distal portion of the first tower; wherein the proximal portion of the first tower has a length that is at least 80% of a length of the distal portion of the first tower; wherein the proximal portion of the first tower is removably coupled with the distal portion of the first tower and the proximal portion of the third tower is removably coupled with the distal portion of the third tower; wherein the proximal portion of the first tower is non-removably coupled with the distal portion of the first tower and the proximal portion of the third tower is non-removably coupled with the distal portion of the third tower; wherein the proximal portion of the first tower is integrally formed with the body portion of the first tower; wherein at least the distal portions of the first tower, the second tower, and the third tower have a complete or a partial tubular shape; wherein the first tower has a pair of hooks configured to receive a pair of wires used during an implantation procedure; wherein the hooks are configured to provide a surface against which the third tower can rotate; wherein the first tower has a projection which provides a fulcrum for rotation of the third tower relative to the first tower; wherein the third tower can have an opening formed through a wall portion of the third tower, wherein the opening can be configured to allow the second tower to pass through the opening of the third tower in an operable state and such that at least a portion of a wall of the third portion at least partially surrounds an outside surface of the second tower; wherein the distal portion of the first tower and/or the third tower is open along one side thereof and not fully enclosed; and/or wherein, in an operable state, an axial centerline of both the distal portion of the third tower and the proximal portion of the third tower extend at a nonzero angle away from the axial centerline of the second tower in a same direction.

Any embodiments of the devices, systems, and methods disclosed herein can include, in additional embodiments, 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 embodiments of the devices, systems, and methods disclosed herein: wherein at least the distal portion of the first tower and the distal portion of the third tower have an adjustable length; wherein at least the distal portion of the first tower, the distal portion of the second tower, and the distal portion of the third tower are generally cylindrically shaped; wherein the proximal portion of the first tower and the proximal portion of the third tower have a cross-sectional profile having a curved shape; wherein the proximal portion of the first tower and the proximal portion of the third tower have a cross-sectional profile having a semi-circular tubular shape; wherein the proximal portion of the first tower and the proximal portion of the third tower have a planar shape; wherein the device, system, or method can include: a rigid connecting element; a first receiving element coupled with the first screw head; a second receiving element coupled with the second screw head; and a third receiving element coupled with the third screw head; wherein the first, second, and third receiving elements are configured to operably receive the connecting element that, in an operable state, extends between the first, second, and third receiving elements when the first, second, and third screws are implanted in a first, second, and third vertebra, respectively; wherein the first tower has at least one opening extending through a side of the distal portion thereof configured to receive a connecting element that is configured to extend between the first, second, and third screws in an operable state, wherein the second tower has at least one opening extending through a side of the body portion thereof configured to receive a connecting element that is configured to extend between the first, second, and third screws in an operable state, and the third tower has at least one opening extending through a side of the body portion thereof configured to receive a connecting element that is configured to extend between the first, second, and third screws in an operable state; wherein the device, system, or method can include one or more covers configured to selectively couple with the first tower, the second tower, and/or the third tower to selectively cover a channel or an opening of the first tower, the second tower, and/or the third tower and increase a torsional or bending rigidity of the first tower, the second tower, and/or the third tower; and/or wherein the device, system, or method can include two or more of the first towers and/or two or more of the third towers, wherein each of the two or more of the first towers define a different angle between the proximal portion and the distal portion of the first towers and each of the two or more of the third towers define a different angle between the proximal portion and the distal portion of the third towers.

Any embodiments of the devices, systems, and methods disclosed herein can include, in additional embodiments, 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 embodiments of the devices, systems, and methods disclosed herein: wherein, in an operable state, the first, second, and third towers are configured to intersect at or adjacent to a skin level of a patient; wherein the device, system, or method can include advancing a connecting element toward the first screw, the second screw, and the third screw and securing the connecting element to the first screw, the second screw, and/or the third screw to prevent the first vertebra from moving back to the first position relative to the third vertebra; wherein the first extension has a proximal portion, a distal portion, and a bend between the proximal and distal portions; wherein the third extension; wherein the first and the third extensions are sized and configured such that the proximal portion of the first and the third extensions are positioned under an outside surface of a patient's skin; and/or wherein the device, system, or method can include advancing the first, the second, and the third extensions through a single incision in a patient's skin.

Any embodiments of the devices, systems, and methods disclosed herein can include, in additional embodiments, 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 embodiments of the devices, systems, and methods disclosed herein: wherein the first extension has a bend between the proximal portion of the first extension and the distal portion of the first extension such that an axial centerline of the proximal portion of the first extension is at an acute angle relative to an axial centerline of the distal portion of the first extension; wherein the third extension has a bend between the proximal portion of the third extension and the distal portion of the third extension such that an axial centerline of the proximal portion of the third extension is at an acute angle relative to an axial centerline of the distal portion of the third extension; and/or wherein the device, system, or method can include moving the proximal portion of the first extension toward a proximal portion of the third extension to rotate the first extension relative to the third extension and move the first screw toward the third screw, thereby moving the first vertebra toward the third vertebra.

Some embodiments disclosed herein can be described as follows:1. A system for bone stabilization, comprising:a first guiding element comprising an elongate body having a first longitudinal axis, a proximal end and a distal end, the distal end configured to engage with a first bone screw;a second guiding element comprising an elongate body having a second longitudinal axis, a proximal end and a distal end, the distal end configured to engage with a second bone screw; andan opening provided at an intermediate portion of the first guiding element when in use, wherein the opening is sized and configured to allow for passage of the second guiding element therethrough such that the second longitudinal axis is at an angle relative to the first longitudinal axis, wherein the opening is sized and configured to limit movement of the second guiding element along the first longitudinal axis.2. The system of Embodiment 1, wherein the first and second guiding elements each comprise a pair of blades.3. The system of Embodiment 2, wherein each pair of blades has one or more bends or curves to increase a separation distance between opposing blades when the pair of blades is engaged with a bone screw.4. The system of Embodiment 1, wherein the first and second guiding elements comprise partial tubes.5. The system of any one of the previous Embodiments, wherein the opening is provided within an intermediate portion of the first guiding element.6. The system of any one of Embodiments 1-4, wherein the opening is provided by an external restraint configured to surround at least the first guiding element.7. A system for bone stabilization, comprising:a first guiding element comprising an elongate body having a first longitudinal axis, a proximal end and a distal end, the distal end configured to engage with a first bone screw;a second guiding element comprising an elongate body having a second longitudinal axis, a proximal end and a distal end, the distal end configured to engage with a second bone screw,wherein the second guiding element is configured to pass through a portion of the first guiding element when the first and second guiding elements are engaged with the first and second bone screws, respectively, and the first and second bone screws are implanted within a patient; andmeans for limiting relative movement and creating a fulcrum between the first and second guiding elements when the second guiding element passes through a portion of the first guiding element and when the first and second guiding elements are engaged with the first and second bone screws, respectively, and the first and second bone screws are implanted within a patient.

Some embodiments are directed to a screw comprising one or more features of the foregoing description. Some embodiments are directed to a device, system and/or method as illustrated and/or described. Some embodiments are directed to a method of operating any of the devices or systems of the foregoing description. Further embodiments are described throughout the following description, including but not limited to systems for stabilizing spinal vertebrae, methods for stabilizing spinal vertebrae, guiding assemblies, screws, rod inserters, methods of operating any of the foregoing, and other devices, systems and methods.

DETAILED DESCRIPTION OF SOME EXEMPLIFYING EMBODIMENTS

Embodiments of the present disclosure relate to medical devices, systems and methods for bone fixation. Specifically, some embodiments disclosed herein can be configured to stabilize adjoining vertebrae in at least the cervical, thoracic, and lumbosacral spine. In addition, some embodiments can be configured to fuse and stabilize vertebrae in the lumbar spine to alleviate axial back pain and radicular pain. Some embodiments can be configured to improve minimally invasive surgical (MIS) approaches to pedicle screw fusion by reducing the number and size of incisions and the size of the medical instruments inserted therein. Further, some embodiments disclosed herein can improve the efficiency of percutaneous lumbar pedicle screw fusion for the surgeon while minimizing the surgical trauma to the patient's tissue.

For example and without limitation, some embodiments of the systems for stabilizing spinal vertebrae disclosed herein are directed towards, but not limited to, improving minimally invasive (optionally adaptable for use with the percutaneous or endoscopic approach) TLIF and PLIF approaches and backing up the ALIF, DLIF™, and XLIF™ approaches. TLIF approaches can provide several advantages including: (i) stabilization of both the anterior and posterior portions of the spine through one or more posterior incision(s); (ii) the ability to fill with bone graft material a greater volume and diversity of spaces (front disc space with the spacer, amongst the screws and rods on the sides, and in the back of vertebrae) increasing the chances of a successful stabilization through the development and solidification of bone; (iii) the spacer placed within the front disc space maintains the natural interbody disc height to reduce pressure on nerve roots (from bone spurs, thickened, ligaments, etc.); and (iv) enhanced safety because the spinal canal is accessed from one side only and this reduces the risk of pinching, stretching, or otherwise agitating the spinal nerves.

Embodiments of the disclosure provide a system, device and/or method for performing a minimally invasive posterior and/or transforaminal lumbar pedicle screw fusion or stabilization procedure. Hereinafter references to “fusion” implicitly include stabilization which offers somewhat greater motion short of completely fusing the bone. Likewise, hereinafter references to “stabilization” implicitly include fusion. The main situations in which a surgeon can use the disclosed system can include a minimally invasive TLIF procedure with either: (i) a micro-lumbar interbody fusion, MLIF™, or (ii) mini-open TLIF on the symptomatic side to decompress the neural compression, and a pedicle screw fusion through a minimally invasive incision on the contralateral side. Similarly, the system disclosed herein would be used bilaterally in a PLIF approach with the decompression and interbody spacer placement performed bilaterally. Alternatively, the disclosed system is ideal for “backing up” (with a minimal posterior incision) anterior interbody fusions (ALIF) and lateral interbody fusions (XLIF™ and DLIF™). MLIF™ collectively encompasses (i) transforaminal lumbar interbody fusions and stabilizations, (ii) posterior lumbar interbody fusions and stabilizations, (iii) anterior lumbar interbody fusions and stabilizations, and (iv) lateral lumbar interbody fusions and stabilizations through a minimally invasive “micro” approach using the guidance system described herein, and (v) posterolateral instrumented fusions where only pedicle screws are placed for posterolateral fusion without using interbody spacers or implants. Since the lateral fusions such as the XLIF or DLIF are truly minimally invasive, a minimal posterior incision for backing up the lateral interbody spacer with pedicle screw fusion would be very complementary. Lateral interbody fusions are becoming more popular and more spine companies are coming out with their own lateral interbody fusion systems. It will be appreciated that although certain embodiments described herein are directed to minimally invasive procedures through a single skin incision, the systems and methods may also be used in open surgery or mini-open procedures through openings in the skin of a patient as desired by the practicing surgeon.

The lumbar spine has a lordotic curvature such that the lowest levels, L4, L5 and S1, have a posteriorly concave orientation or alignment, while the upper levels, L1-L3, are less lordotic. This curvature sets up a unique situation in which the trajectories through the pedicles (the trajectories to insert the pedicle screws) from L2 to S1 are not parallel. Rather, the trajectories commonly intersect at a point around the level of the skin. This configuration is similar to the spokes of a wheel in which the spokes (trajectories) meet at a common center point (a hub). Given that many patients have such a lordotic configuration of the lumbar spine, it is possible to insert pedicle screws through a single incision centered in the middle of the lumbar curvature. However, if each screw required a separate tower (or tube) (as in conventional tower/tube systems) in order for multiple screws to exist simultaneously, then the sum cross sectional area of the towers/tubes does not permit a single small incision. The towers/tubes interfere with each other and get in the way of one another due to their size. It is also difficult to place the rod through the channels of the towers and into the seats of the pedicle screws when the towers of the pedicle screws are crossed and not aligned in a straight line.

An alternative method is necessary in order to minimize the number and size of incisions. Reducing the number and size of incisions minimizes the tissue trauma needed to place pedicle screws for lumbar stabilization or fusion. An ideal system and procedure would take full advantage of the natural curvature of the lumbar spine in order to provide this reduction. However, the apparatuses and methods of the present application described and claimed herein are not limited to applications in the lumbar vertebrae and may also find use for fusing, stabilizing, or otherwise treating vertebrae in other regions of the spine such as the cervical spine where lordotic curvature is again the typical anatomical alignment.

The number of osteoporotic spinal patients requiring surgical intervention is increasing. Historically this complex group of patients has had complications with bone-screw fixation due to the nature of the bone and types and projection geometries of the screws used, along with their methods of insertion. These complications include implant failure, screw loosening and pullout. Recent research suggests new cortical screws that project in an anteromediolateral direction have advantages over traditional screws projecting in an anteromedial direction. Embodiments of the present disclosure take this research into account and can be used in guiding and placing new cortical screws to project in an anteromediolateral direction in order to overcome many problems of traditional screws in osteoporotic patients. Further, embodiments of the present disclosure can be used to place multiple new cortical screws through a single incision, minimizing trauma to already sensitive osteoporotic patients.

The last steps in pedicle screw fusion can involve rod reduction and final tightening. Rod reduction is typically necessary if there is malalignment in the vertebral bodies such as spondylolisthesis. In this case, the malalignment can be realigned by pulling or pushing on the pedicle screw that is anchored into that vertebrate relative to other screws in other vertebrate. By adjusting the relative position of the screws heads, a preferably bent rod can be lowered into the screw heads and “reduce” the malalignment or spondylolisthesis. In open surgeries, the reduction process is usually performed by rod reduction tools that push the rod into the screw head. In MIS systems, extended threads on the tower or extended tab that extend higher than the screw head can reduce the rod into the screw head by allowing the locking cap to engage with the threads at a higher position thereby capturing the rod at a position higher up or farther away than the final seat of the screw head.

After the rod is reduced and the vertebrate are aligned, the rod can be locked into the screw heads by locking caps. The locking caps are usually tightened to the final torque using a counter-torque instrument. The counter-torque usually is a sleeve that passes over the screw head as well as blades or towers (if present). The counter-torque can have grooves that fit over the screw head and often also the rod in order to provide a counter force when the locking cap is final tightened. The counter-torque can stabilize the screw heads so that any rotation of the screw head during final tightening is minimized.

During the final tightening process, it is also common to provide compression of the screw heads. Compression during final locking is thought to help with the fusion process as any interbody fusion is thought to be more successful under pressure or compression. Compression also helps place pressure upon the interbody spacer and reduces the chance that the spacer will back out, retropulse, or migrate. Compression is also useful to restore lumbar lordosis. Many interbody spacers placed either anteriorly through an ALIF, laterally through an XLIF or DLIF, obliquely through OLIF (oblique lateral interbody fusion), or posteriorly through PLIF or TLIF all can have lordotic profiles. The new expandable cages allow even more significant lordosis. The compression during final tightening can optimize the lordosis through posterior compression during final locking.

Typical pedicle screw system use separate tools for screw insertion, screw alignment, rod insertion, cap insertion, rod reduction, counter-torque, and final tightening. These separate tools all require extra steps at each pedicle screw. Each extra step introduces more irritation of muscle and tissue as well as time. Thus, a system that allows a pedicle screw that is preattached to a tower system that can perform all these tasks without any extra tools is indeed time saving and optimal. Some embodiments disclosed herein describe a system of towers that are removably attached to pedicle screws. In some embodiments:Towers can cross paths without interference (in situations with lordosis);Towers can be used to align the screw heads without the need for a separate tool to straighten the screw heads;Towers can be used to measure the length and curvature of the rod;Towers can allow easy rod placement and visualization of the rods even in MIS approach and even in large patients where visualization is difficult;Towers can allow and/or facilitate rod reduction, and reduction of spondylolisthesis;Towers can allow final tightening under compression or distraction without a separate compression or distraction tool;Towers can provide counter-torque during final tightening without a counter-torque tool; and/orTowers attached to screws can be placed robotically and allow rod placement, rod reduction, compression, and final tightening with counter-torque all to be performed robotically through a mechanical coupling of parts of the tower system with robotic arms. The robot, navigation system, software can be configured to know the positions of all towers screws, rods and caps at all times.

The intersecting tower system of some embodiments disclosed herein can allow or provide an optimal MIS system where incision size and tissue damage is minimized, surgical steps are optimized, number of tools are minimized, and surgical time is reduced. Previous MIS tower systems are either placed in an awkward configuration where the screw trajectories are crossed due to lumbar lordosis with the towers angled to be parallel to each other. Otherwise, MIS towers are placed though a single incision and the towers are crossed next to each other, making rod insertion, and final tightening very difficult and frustrating. Some embodiments of the present disclosure can avoid these difficulties and can provide an optimized MIS pedicle screw system.

Some embodiments disclosed herein provide a simple method and associated apparatus to place two or more pedicle screws through one small hole. This provides a better cosmetic and functional result with just a single skin incision of small size (approximately 0.5 to 4 cm in length, approximately 0.5 to 3 cm in length, or approximately 1 to 2 cm in length) regardless of the number of screws used. In one embodiment, the single incision is smaller than the sum of the maximum widths of two respective largest elements for each screw that is inserted through the single incision, where an element includes the screw, screw head, rod, locking assembly and associated tools.

Some embodiments disclosed herein are configured to enable a surgeon or other user to insert, position, and manipulate a spinal implant such as a rod and a locking assembly through the same small incision in order to lock the rod within the screws. Certain embodiments provide novel ways to insert a rod into the heads of pedicle screws and ways to lock the rod within the screws through a single small incision. The systems and methods involve in certain embodiments the attachment of guide elements consisting of the following: one or more flexible wires, flexible yet firm extended blades, extended tabs, or towers attached to each pedicle screw head to be used to guide the rod down to the screw. The guide elements are configured and combined so that they can overlap or intersect at or below the skin incision, thereby enabling the use of a small, single skin incision. The screws, rods, and locking assemblies can all be placed through a single small incision and yet still be appropriately interconnected within because of the natural lordotic curvature of the lumbar spine. By attaching at least one guidance element on each side of the screw head, the guidance elements assist to align the screw head. The guidance elements also trap or restrict displacement of the rod, forcing it to fit between them and directly into the screw head.

Compared to U.S. Pat. No. 7,179,261 to Sicvol described above, embodiments of the present disclosure eliminate the need for “cut-outs” where the guide elements intersect. For example, in embodiments utilizing extended tabs or blades, these extended tabs or blades do not have a proximal, distal, or any lumen, and the configuration of guidance elements (extended tabs or blades) for screws at adjacent levels allow the tabs to intersect and overlap completely for any patient with any relative geometries. Thus interference between adjacent guidance elements on adjacent vertebrae is not a problem. Also, in the cut-out tubes taught by the '261 Patent, a rod or other element would still have to be inserted through the tube at some point. The cut-out tubes require that the rod (or other inserted element) is oriented longitudinally parallel to the long axis of the tube as it is directed into the body until it reaches a section with side wall openings or slots distal to the cut-out section, at which point it may optionally be turned perpendicularly to the long axis and directed out of the side wall through the opening or slot. In embodiments of the present disclosure by using guidance elements such as extended blades or extended tabs (from the screw head), the element that is guided by them and inserted along them (e.g., a rod, a locking assembly etc.) does not have to be inserted through any lumen. When a rod is inserted using the blades, the blades can simply be fed through the outer edges of the rod body, through a retaining element or clasp attached to the rod body, or between the outer edges of the rod body and a retaining element (retention thread). Thus, it is possible for the inserted rod or other elements to be oriented perpendicular to the long axis or oriented in any other manner or at any angle during the entire entry pathway. This provides greater flexibility for avoiding interference between adjacent stabilization system pieces and eliminates the need for a surgeon to identify the cut-out sections before turning the screw/rod perpendicularly and/or reorienting it. Furthermore, since there are no lumens proximally or distally with the extended tabs, blades from adjacent levels may overlap and intersect without the need for cutout therefore allowing all blades to exit a single small minimal incision.

The guidance elements can also be used to guide the locking assemblies down to the screw heads for embodiments in which the locking assembly is not part of the screw head itself (and already down there).

Another embodiment is a hybrid system where each screw is placed through short towers or tubes that do not come to the skin surface. Wires, blade or tab extensions are attached to the top of the towers or tubes so that the screw, rod, locking assembly, and tools used for insertion, adjustment, locking, compression, distraction, and removal are guided by the extensions close to the skin but through individual towers or tubes close to the bone and pedicle screw. This hybrid system offers both the advantages of the wires/extended blades/tabs in which many guidance elements can overlap in a single incision at the skin level and the advantages of a tower or tube system are preserved at the bone level. Some surgeons who are comfortable with the tower system but who want the advantages of the blade/tab system may want to use this hybrid system.

Making some of the guidance elements telescopic allows for more guidance elements to fit through a single incision smoothly, thereby advantageously reducing the need to have a larger incision and/or multiple incisions. After insertion, the various guidance elements may be deployed telescopically as needed. Using telescoping components as part of the upwardly directed extended guidance elements allows a rod for stabilizing vertebrae to be inserted into the body through the telescoping components and through the same singular incision, minimizing invasiveness of the procedure.

All combinations and arrangements of towers, tubes, blades, arms, tabs, wires, and other upwardly directed extended guidance elements, either as described herein or in hybrid systems which combine conventional tower/guidance elements as described in the prior art (such as described in the references incorporated by reference throughout this specification) are contemplated as within the spirit and scope of the present disclosure. As used herein, the term guiding or guidance element is intended to include one or more components extending between a screw and a skin incision, preferably directly or indirectly coupled or detachably connected to a screw head, and includes both conventional towers or tubes such as those made of rigid or semi-rigid materials as described in the patents and publications incorporated by reference throughout this specification, as well as the additional embodiments of guiding or guidance elements as described herein. The most suitable selection and arrangement is for the surgeon to determine in each particular case. For example, in one embodiment, there may be telescoping tubes at one level, wires at the next level, and blades at the next level on one side (of the slot for the rod) with blades attached to wires on the other side (of the slot for the rod). Different variations may be selected for each side (medial, lateral) in order to introduce more components through the same incision. The goal is to provide enough guidance elements to properly guide the stabilization rods, locking assemblies, tools, etc. to the pedicle while minimizing the number of incisions and preventing overcrowding. Eliminating overcrowding permits proper visualization so that the surgeon can work comfortably and efficiently.

In some embodiments, a system is provided for performing spine stabilization through an opening in skin of a patient. 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 guiding element (also referred to herein as a first extension) comprising a height component detachably connected to the first screw, the first screw being configured for implantation in a first vertebra. The system also comprises a second screw having a screw head and a second guiding element detachably connected to the second screw, the second screw configured for implantation in a second vertebra. The first screw with the first guiding element and the second screw with the second guiding element can be delivered into the first and second vertebra.

Other objectives and advantages of embodiments of the disclosure will be set forth in the description which follows. Implicit modifications of the present disclosure based on the explicit descriptions will be, at least in part, obvious from the description, or may be learned by practice of the disclosure. Such subtle, predictable modifications and adaptations are taken to be within the scope of the present disclosure. Additional advantages of the disclosure may be realized and obtained by means of the instrumentalities and combinations particularly pointed out hereinafter.

Embodiments disclosed herein include improved systems, apparatuses and methods for guiding one or more screws, rods, and locking assemblies down to the vertebrae and for securing a rod or other spinal implant to stabilize the vertebrae. Embodiments of a device or system for stabilizing spinal vertebrae are disclosed herein, as shown inFIGS.1A-1Z, though the features of this system may be utilized with all of the other embodiments described throughout this specification. In some embodiments, the system for stabilizing spinal vertebrae can include pedicle screws. In some embodiments, the screw110(shown as110A in some of the figures) can include a bone engaging shaft112and a screw head114. In some examples, the bone engaging shaft112is threaded. The bone engaging shaft112may be relatively moveable to different angles relative to the screw head114. In some embodiments, the screw head114has generally a U-shape, defining upwardly extending arms that form a channel for receiving a rod120. The rod120may either sit on the head of the bone engaging shaft112, or may sit on an insert116placed in the screw head114for receiving the rod120.

A locking assembly may be built into or attached onto the screw head or be a separate element. Locking assemblies that are separate elements include (but are not limited to) those reliant on caps and set screws. Locking assemblies integrated with the screw head can include (but are not limited to) rotatable mechanisms in which a turn of the screw head traps the rod. The locking assembly may be guided down to the screw before or after insertion of the rod depending upon the details of the locking mechanism used to secure 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 inserted into the screw head114first and the locking assembly follows. In some embodiments, the upwardly extending arms of the screw head114may be internally threaded to receive an externally threaded cap screw that is rotated into the screw head114to apply a downward force to a rod120sitting in the channel of the screw head114. This downward force may also then lock the position of the screw head114relative to the rod120.

The guidance elements for directing the rod120, various locking assembly components (e.g., screw head caps), surgical insertion and manipulation tools, and other components into position may be any type of upwardly directed, extended guidance elements. These guidance elements are preferably detachably connected to the screw heads or screws so that they can be easily removed once a procedure is completed. Suitable guidance elements include: tubes, towers, blades, arms, extended tabs, wires, string, etc. In some embodiments, the guidance elements extended tabs or extended blades run from a site adjacent the screw head up through the incision site. In some examples, the guidance elements can be curved (along one or more axis) or bent (along one or more axis) to accommodate the cap and other components. The guidance elements may also be curved or bent in order to be offset from adjacent elements such that they do not interfere if and when they cross. The curvature may be a permanent rounded shape or they may be flexibly curveable or comprised of foldable panels. The curves and bends may be permanent and pre-formed or adjustable in situ. The extended guidance elements may also be tapered, threaded and/or notched to assist in stabilizing the cap or other components as they are lowered down to the screw head.

In some embodiments, the guidance elements comprise two or more blades that may be offset from each other. In some examples, the offset configuration of the two or more blades allows the two or more blades to cross as the two or more blades do not interfere with each other. In some embodiments, the plurality of blades132of the guidance elements130of each of the screws110can be configured to cross and/or overlap as described above. In some examples, the guidance elements can be offset in any functional manner, and can assume different positions around the screw heads (e.g., for staggered crossing), bending at different positions (e.g., straight to bent), curvatures that are non-intersecting with adjacent elements (blades from adjacent screw head), etc.

The extended tabs/blades or other guidance elements on adjacent screws may be offset such that they do not interfere with one another when they intersect. Rather, as they cross one another, the extended tabs/blades (or other guidance elements) can be configured to smoothly pass by one another. Therefore the extended tabs/blades on adjacent screws can be inserted through the same small incision and manipulated within that incision. This may be achieved by tabs/blades, or other guidance elements, on the inside of one screw and the outside of the other screw. In some embodiments, the tabs/blades for adjacent screws can simply be staggered or misaligned. In some examples, one screw can have a single tab/blade on the medial side while another screw has a single tab/blade on the lateral side. In some embodiments, one screw can have extended tabs, while one or more of the other screws can have flexible wires as guidance elements.

In some embodiments, some of the extended guidance elements (tabs, blades, etc.) on some screw heads may be straight while those on others are bendable or angled, such that the bendable or angled elements cross over the straight ones to exit the body through the same skin level incision. In other embodiments, a first screw is connected to a first extended guidance element in the form of a plurality of blades and a second screw is connected to a second extended guidance element in the form of a plurality of blades. The plurality of blades of the first extended guidance element can overlap and/or intersect with the plurality of blades of the second extended guidance element. Advantageously the first extended guidance element and the second extended guidance element can intersect or overlap at or near a skin level incision. By intersecting or overlapping at or near a skin level incision, this allows both of the guidance elements to extend through a single, small incision.

The extended tabs/blades or other guidance elements are configured to easily detach from the screw head upon completion of directing rods, caps, instruments, and other components precisely to the screw head. This detachment process may occur by any number of means, including break-off along a pre-perforated or notched line, burning or melting at the base of the tabs/blades with an instrument, releasing a mechanical clamp, etc. In some embodiments, the extended guidance elements (e.g. extended tabs, extended blades, etc.) for adjacent screws may be attached to their respective screw heads at different positions along the screw head to produce the offset configuration. In some examples, the extended guidance elements may be attached to their respective screw heads at the same location and bent at different angles to form different configurations that are offset with respect to one another when crossed. For example, the extended guidance elements may be bent to come out of the screw head at different lateral displacements such that they do not interfere with one another. In some embodiments, for a two level fusion, three offset extended guidance elements (tabs, blades, etc.) attached to three adjacent screws can be used. In some examples, for a three level fusion, four offset extended guidance elements attached to four adjacent screw can be used. In some embodiments, for a level four fusion, five offset extended guidance elements attached to five adjacent screws can be used. In a level four fusion, potentially all of the five offset extended guidance elements can be configured to come through the same skin level incision and crossing at some point at or near the same level skin incision.

In some embodiments, the extended tabs/blades/arms and wires can work together in a “hybrid” concept. For example, a first tab/blade/arm can be attached to the screw head and is configured to be easily detachable. Additional tabs/blades/arms between the screw head and distal wires protruding from the skin can be added and/or removed as needed to lengthen or shorten the distance of the guidance trajectory. In some embodiments, the guidance element can include a multitude of breakoff tabs/blades/arms that are attached to one another in series to create a long extended blade. The blade can then be tailored to the appropriate length, such as at the level of the skin incision, by breaking the tabs off at the closest breakoff point to the desired length. In some embodiments, one or more of the breakoff tabs can be attached to a proximal wire to keep track of and locate the tab within the patient.

In some embodiments, flexible guidance wires can be used to direct other guidance element features (e.g., tabs, blades, arms) during insertion and removal. The guidance wires can serve as a guide to direct add-on tab elements into place within the patient. In some examples, a plurality of flexible guidance wires can serve alone as guidance elements to guide rods, tools or locking assembly components to a desired location at or near the spine. In some embodiments, the flexible guidance wires can be part of a “hybrid” concept and can work in conjunction with tabs/blades/arms to guide elements to a desired location. The rods, tools or locking assembly components can be delivered via the guidance elements by hand, or in some embodiments, using a stereotactic guidance mechanism and/or by a robot.

Additional embodiments of systems and methods for pedicle screw stabilization of spinal vertebrae are also disclosed in U.S. Pat. No. 8,721,691, the entire contents of which are hereby incorporated by reference in its entirety.

As used herein, distal is defined as a space farther from a particular location, and proximal is defined as a space closer to the particular location. In some embodiments, a portion of a tab or blade that extends out beyond an incision can be considered a proximal portion, while a portion of a tab or blade that is beneath the incision can be considered a distal portion.

Systems, Devices and Methods ofFIGS.1A-1Z

FIGS.1A-1Zillustrate an embodiment of the method for implanting a plurality of screws into a plurality of vertebrae and the implantation and securement of a rod. The method disclosed inFIGS.1A-1Zinclude the screw110aand screw110billustrated above. Although the method illustrated only includes two screws, the disclosed method can be used for any number of screws to be implanted in any number of vertebrae in any order.

FIG.1Aillustrates a first guidewire160aand a second guidewire160bthat are positioned at a target location on a first and second vertebra. As illustrated, the first guidewire160ais directed to a vertebrae that is inferior to the vertebrae that the second guidewire160bis directed to. Each of the first and second guidewires160a,160bare configured to directed a first screw110aand a second screw110bto their respective vertebrae. As is illustrated inFIG.1B, the first screw110ais directed down the first guidewire160a. As discussed above, the first screw110aincludes a bone engaging shaft112aand a screw head114aand a plurality of wires140a,140b, where at least one wire of the plurality of wires140ais located on either side of the screw head114a.

Once the screw110ais guided to the target location on the first vertebra, as illustrated inFIG.1D, the bone engaging shaft112ais screwed into and retained in the first vertebra. As illustrated inFIG.1E, once the screw110ais secured, the guidewire160ais withdrawn out of the body.

FIG.1Eillustrates a perspective view of the implanted first screw110a. As illustrated, the wires140aare attached at a distal end to the screw head114asuch that the proximal end of the wires140aextend out of the incision150. To prepare for the implantation of the second screw110b, the plurality of wires140aare bent away from each other to increase access to the incision (seeFIG.1F).

Similar to the implantation of the first screw110a, the second screw110bcan be guided to the second vertebra by the second guidewire160b. In some embodiments, as illustrated inFIG.1G, the second screw110bcan be inserted with the distal end139of the tower130retained about the proximal end of the screw head114b. As will be seen more clearly in subsequent figures, the tower130is disposed about the plurality of wires140b. In some examples, as is illustrated inFIG.1H, the proximal end of the wires140bextends from the proximal end138of the tower130.

FIG.1Iillustrates a perspective view of the implanted first screw110a, the implanted second screw110b, and the tower130disposed about the wires140band the screw head114bof the second screw head114b. As illustrated, the second guidewire160bhas been removed and the plurality of wires140aremain bent away from each other to allow access to the window131of the tower130.

FIGS.1J-1Lillustrate the insertion and placement of the rod120into the first insert116aof the first screw110aand the second insert116bof the second screw110b. In some embodiments, the rod120(or other implant) can be inserted through the incision150and between the bent wires140aand the window131of the tower130. In some examples, a first end121of the rod120is passed through the window131of the tower130. The first end121can be guided down the window131of the tower130and the distal end of the wires140auntil it enters the insert116aof the first screw head114ain the first vertebra. In some examples, the second end122of the rod120is guided down the window131until it enters the insert116bof the second screw head114ain the second vertebra.

In some embodiments, in order to secure the rod120in the first screw110aand second screw110b, a locking assembly can be inserted over the rod120. As discussed in more detail above, the locking assembly may be built into or attached onto the screw head or be a separate element. Locking assemblies that are separate elements include (but are not limited to) those reliant on caps and set screws. The locking assembly may be guided down to the screw before or after insertion of the rod depending upon the details of the locking mechanism used to secure 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 inserted into the screw head114first and the locking assembly follows. In some embodiments, as illustrated inFIGS.1M and1N, the locking assembly is a screw cap170that can be placed over the rod120. As illustrated inFIG.1M, the screw cap170can be placed into the opening133at the proximal end138of the tower130. The tower130is configured to guide the tower130into the screw head114bof the screw110b(seeFIG.1N). In some embodiments, the upwardly extending arms of the screw head114bcan be internally threaded and the screw cap170can be externally threaded. To secure the screw cap170, the externally threaded screw cap170can be rotated into the screw head114bto apply a downward force to the rod120sitting in the insert116bof the screw head114b. This downward force can also then lock the second end122of the rod120such that the screw head114bis secured relative to the rod120.

In some examples, the tower130can be moved from accessing one screw to another screw.FIGS.1O-1Villustrate the tower130moved from accessing the second screw110bto accessing the first screw110a. As shown inFIG.1O, the tower130can be withdrawn in a proximal direction such that the distal end139of the tower130is disengaged from the proximal end of the second screw head114b. As the tower130is withdrawn, the tower130is pulled along the length of the wires140battached to the proximal end of the screw head114b(seeFIG.1P).FIGS.1Q-1Sillustrates a perspective view of the implanted first screw110aand the second screw110b. In some embodiments, in order to allow the tower130to be disposed about the plurality of wires140aof the first screw110a, the wires140acan be bent such that the pair of wires140aare brought closer to each other (seeFIG.1R). In some examples, the plurality of wires140bcan be bent away from each other to provide additional room and access to the incision150(seeFIG.1S).

FIG.1Tillustrates a side view of the implanted first screw110aand the second screw110b. In some embodiments, once the wires140aand wires140bhave been bent to accommodate the tower130, the tower130can be disposed about the wires140aof screw110a. As shown inFIGS.1U and1V, the tower130can be inserted in a distal direction such that the distal end139of the tower130is disposed about the proximal end of the screw head114a.

As discussed with regard to the insertion of the screw cap170into the screw head114aof the screw110a, a second screw cap170can be inserted through the opening133at the proximal end138of the tower130. As shown inFIGS.1W and1X, the second screw cap170can be guided to the screw head114aof the screw110a. As discussed above with regard to the first screw cap170, in some embodiments, the upwardly extending arms of the screw head114acan be internally threaded and the second screw cap170can be externally threaded. To secure the second screw cap170, the externally threaded screw cap170can be rotated into the screw head114ato apply a downward force to the rod120sitting in the screw head114aof the screw head114a. This downward force can also then lock the first end121of the rod120such that the screw head114ais secured relative to the rod120.

Once the first screw110aand the second screw110bare implanted and the rod120is secured by the first screw cap170and the second screw cap170, the tower130can be withdrawn from the incision150. In some embodiments, as illustrated inFIG.1Z, the first pair of wires140aand the second pair of wires140bcan be removed from the implanted first screw110aand second screw110b. In some examples, the wires140a,140bare snapped off along with a proximal end of the screw head114a,114b. As shown inFIG.1Z, in some embodiments, the first screw cap170and second screw cap170are adjacent to the proximal end of the screw head114a,114b.

Systems, Devices and Methods ofFIGS.2A-2T

FIGS.2A-2Tshow another embodiment of a method and a system200for stabilizing spinal vertebrae. Any of the embodiments of the system or systems disclosed herein can have 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 of the other embodiments of the implant systems disclosed herein or which are disclosed in U.S. Pat. No. 8,721,691 or components thereof, which is incorporated by reference herein as if fully set forth herein, in place of or in any combination with any of the components, features, and/or other details disclosed herein for the embodiments of the system or systems disclosed below, including without limitation any of the embodiments of the system200. Additionally, any of the steps, sequences of steps, or procedures described above with respect to any other system embodiments or which are disclosed in U.S. Pat. No. 8,721,691 can be used in place of or in any combination with any of the steps, sequences of steps, or procedures described below for any of the embodiments of the systems disclosed below (including, without limitation, the embodiments of the system200) to form new steps, sequences of steps, and procedures for the embodiments of the system disclosed below (including, without limitation, the embodiments of the system200).

FIG.2Ashows a first guidewire202and a second guidewire204(which can be K wires) of the spinal stabilization system200advanced through an incision206and into the target locations in a patient's vertebra. In any embodiments, as illustrated the first and second guidewires can be advanced through a single incision. In other embodiments, three or more guidewires for three or more devices or implants can be advanced through a single incision.FIG.2Bshows a first extension208having a proximal end portion208aand a distal end portion208bthat can be coupled with a first screw210advancing over the first guidewire202through the incision206. The screw210can be selectively removable from the extension member208, at a distal end portion208bof the extension member208.

The following is a description of some embodiments of the system200for stabilizing spinal vertebrae that can be performed through a single skin incision, such as incision206. As shown inFIGS.2A-2T, any embodiments of the system200can include a first screw210having a first screw head210a, a second screw230having a second screw head230a, a first extension208having a body portion209, and a second extension228having a body portion229. The first extension208can be configured to be removably coupled with the first screw210at a first end of the body portion209of the first extension208by any of the techniques or using any of the components known in the art or as disclosed herein, and the second extension can be configured to be removably coupled with the second screw at a first end of the body portion229of the second extension228by any of the techniques or using any of the components known in the art or as disclosed herein. The first extension208can further include a handle portion214(also referred to herein as a handle member) that can be coupled with a proximal end of the body portion of the first extension. The handle portion214can extend away from the proximal end of the body portion of the first extension208at an angle. Note that the terms guiding element or extension element can be used to describe the extension components described herein.

First Extension:

In any embodiments the first extension208can be shorter than the second extension. For example and without limitation, the first extension208can be sized such that a proximal end of the body portion209of the first extension208extends to a height just below the skin of a patient when the first screw210is implanted in a first vertebra211, or wherein a proximal end208aof the first extension208extends to a height just below the skin of a patient, or to a height level with the skin of a patient, when the first screw210is implanted in a vertebra. Alternatively, the first extension208can be sized such that only a proximal end portion208aof the first extension208(for example and without limitation, 10% or approximately 10% or less of the entire length of the first extension208, or from 5% or approximately 5% to 10% or approximately 10% of the entire length of the first extension208) extends through the skin incision206when the first screw210is implanted in a vertebra, or such that no portion of the first extension208extends through the skin incision when the first screw210is implanted in a vertebra. Further, in any embodiments, the first extension208can be sized such that the entire body portion209of the first extension208is positionable below a skin surface of a patient, with only the handle portion214extending through the skin incision, when the first screw210is implanted in a vertebra.

For example and without limitation, a surgeon can measure a distance from the vertebra to the skin surface and select a first extension208having a suitable length to match, or approximately match, the distance from the vertebra to the skin surface. In some embodiments, the first extension208can have an adjustable length, such as a telescoping body that can be adjusted by a surgeon before and/or after the first screw210is implanted. In this configuration, a length of the first extension208can be, but is not required to be, adjusted so that the entire length of the first extension is at or below the skin surface of the patient, or substantially at or below (as described above) the skin surface of the patient.

In any embodiments, the second extension228can be sized to extend completely through the skin incision206when the second screw230is implanted in a vertebra. In some embodiments, the body portion209of the first extension208can have an adjustable length. In some embodiments, each of the first extension208and the second extension228can have a fixed length. In some embodiments, the first and second body portions can be generally cylindrically shaped.

FIG.4shows the handle portion214(also referred to herein as a handle) that can be coupled with or integrally formed with the first extension208. The handle portion214can have a proximal portion214aand a distal portion214b. In any embodiments, the handle portion214can be coupled with the first extension208at a proximal end portion208aof the first extension208. The handle portion214and the first extension208can be configured such that a surgeon or other user can rotate, move, torque, bend, or otherwise manipulate the first extension208when the first extension is inside the incision using the handle portion214, when the handle portion is positioned outside of the body.

In any embodiments, the handle portion214can extend away from the first extension208at any desired angle. For example and without limitation, in some embodiments, the handle portion214can extend away from an axial centerline of the first extension208at an angle A (as shown inFIG.2C) that is 45° or approximately 45° from the axial centerline of the first extension208, or from 30° or approximately 30° to 50° or approximately 50, or from 40° or approximately 40° to 45° or approximately 45° from the axial centerline of the first extension208. Furthermore, in some embodiments, the angle of the handle portion214in relation to the first extension208may be variable through a joint attachment or adjustable angle connection between the handle portion214and the first extension208. Additionally, the handle portion214can have any desired length. In some embodiments, the length of the handle portion can be varied such that a user can select the desired length of the handle portion from a kit of various sizes of handle portions, or the length of the handle portion can be adjustable. In some embodiments, the length of the handle portion214can be the same or approximately the same as the length of the first extension208, or within 25% of the length of the first extension. The handle portion214or any other handle portion of any embodiment disclosed herein can optionally have any desired cross-sectional shape, including flat, curved, round, ovular, or otherwise. The handle portion214or any other handle portion of any embodiment disclosed herein can optionally can also have any desired longitudinal shape or curvature, including curved away from the skin, undulating curve to fit the grip of a surgeon's hand, or a curvature that couples with the handle portion of the second screw to provide a fulcrum thereby allowing compression of the screw heads when the two handles are squeezed.

The device200can be configured such that a handle portion214attached to the proximal end of the first extension208can be grasped by a surgeon to enable a surgeon to manipulate the first extension208and, hence, the first screw210and the first vertebra that the first screw210is anchored to or coupled with during the surgical procedures. In this configuration, a surgeon can, for example and without limitation, exert a compressive force on adjacent vertebra, or a decompressive force on adjacent vertebra, or rotate, torque (including a counter-torque force on the screw when a set screw is being installed to secure a rod between adjacent spinal screws), bend, or otherwise manipulate the first extension, first screw210, and/or first vertebra. In some embodiments, the handle portion214can be used to exert a rotational force on the first extension208about at least a centerline axis of the first extension. For example and without limitation, the handle portion214can be configured to be grasped by a surgeon to enable a surgeon to manipulate the first extension, or to be grasped by a surgeon to enable a surgeon to exert a rotational force on the first extension208about the centerline axis of the first extension.

The handle portion214can be a separate component that is configured to be removably coupled with the body portion of the first extension. In some embodiments, the handle portion214can be removably coupled with the body portion of the first extension, the handle portion214having an end portion that can be receivable in a notch, groove, or other receptacle formed on a side of the body portion of the first extension. For example, the handle portion214can be separate from the extension and can be inserted into a notch, groove, or receptacle formed in one side of the first extension. In this configuration, the screw can be inserted with the first extension208using an inserter. During insertion, the inserter can be placed through the first extension208and inserted like a normal tower or extension configuration. But along the side of the inserter can be a groove or slots that lead to grooves or slots along the wall of the first extension. Thus, after the screw is inserted, but with the inserter still attached to the screw and first extension, then the handle portion214can be slid along the side of the inserter with a corresponding groove or configuration to accept the handle portion214and allow the handle portion214to slide down into the groove and slot in the wall of the first extension. The system can have locking mechanisms or features to selectively secure or lock the handle portion214in place in the wall of the first extension. In some embodiments, the handle portion214can be non-removably coupled with the body portion of the first extension, or integrally formed with the body portion of the first extension.

In any embodiments disclosed herein, the first extension208can have a recess or cutaway215formed therein at a mid-portion and/or the proximal end of the body portion209of the first extension208that can be configured to receive a portion of an outside surface of the body portion229of the second extension228therein in an operable state. The recess215can have a shape that generally complements a shape of an outside surface of the body portion229of the second extension228. For example, in some embodiments wherein the body portion229of the second extension228has a round or circular cross-section, the recess215can have a curved profile or cross-section that accommodates the round or circular cross-section of the second extension228. In some embodiments, the first extension208can have the recess215formed therein at least the middle portion and the proximal end208aof the first extension208, the recess being configured to receive a portion of an outside surface of the body portion229of the second extension228therein in an operable state. The handle portion214can extend away from the body portion209of the first extension208in a direction that is generally away from the recess. In this configuration, the second extension228can be positioned more closely to the first extension208and can be advanced through a smaller incision in the patient's skin. The recess215can result in a more compact system during operational procedures that can reduce the size of the incision, among other benefits.

In some embodiments, the first extension208can 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 an outside surface of the body portion229of the second extension228therein in an operable state. The handle portion214can be coupled with a first side of the body portion209of the first extension208and the recess can be formed on a second side of the body portion209of the first extension208that can be opposite to the first side of the body portion of the first extension. In some embodiments, the handle portion214can attach to the body portion209of the first extension208adjacent to a recess formed in the body portion of the first extension. In some embodiments, some details of the recess can be similar to the recesses of the embodiments shown in FIGS. 39-45 of U.S. Pat. No. 8,721,691, the details of such embodiments shown in such figures and described therein being incorporated by reference as if fully set forth herein.

In some embodiments, the system can further include at least one handle portion (similar to the embodiments of the handle portion214disclosed herein) coupled with the body portion229of the second extension228, or two handle portions coupled with the body portion229of the second extension228, which can be used with the handle portion214that is coupled with the first extension208.

Any embodiments disclosed herein can further include a linking member216(which is also referred to herein as a restraint, such as with respect to restrain650described below, retention member, ring or ring member) that can be configured to couple the first extension208and the second extension228together, as shown inFIG.21, among others. The linking member216can be rigid and can be formed integrally with or separately from the first extension208and welded, brazed, or otherwise coupled with the first extension. In this configuration, the linking member216can provide a selectable or reversible link or connection between the first extension208and the second extension228. Any embodiments of the linking member216can be configured to improve the control and manipulation of the second extension228relative to the first extension208, and/or the first extension208relative to the second extension228. For example and without limitation, using the linking member216and the handle portion214, the surgeon can exert a force on the first extension member208relative to the second extension member228to move the distal end208bof the first extension member208toward the distal end228bof the second extension member228to exert a contraction force on the first and second vertebra, or exert a force on the first extension member208relative to the second extension member228to spread the distal end208bof the first extension member208away from the distal end228bof the second extension member228to exert a traction force on the first and second vertebra.

In some embodiments, the linking member216can be coupled with and surround all or a portion of an outside surface of a proximal end208aof the first extension208and the body portion229of the second extension228in an operable state. In other embodiments, the linking member216can be coupled with and extend away from an outside surface of the first extension208. With reference toFIG.21, in some embodiments, the linking member216can have an opening217therethrough that is aligned with the recess215formed in the first extension208that is sized and configured to receive the second extension228therethrough so that the second extension208can be advanced through the opening217and through the recess215as the second extension is advanced toward the patient's second vertebra.

Additionally, any embodiments can also have a linking member216. In some embodiments, the linking member216can be coupled with or integrally formed with the first extension208. In any embodiments, the linking member216can be coupled with the first extension208at a proximal end portion208aof the first extension208. In some embodiments, the linking member216can surround a portion of the first extension208and/or a portion of the handle portion214, adjacent to a proximal end208aof the first extension208and/or a distal portion214bof the handle portion214. In other embodiments, the linking member216can extend away from a side of the first extension208without surrounding any portion of the first extension208. In some embodiments, the linking member216can be configured to provide a loose connection between the first extension208and the second extension228.

Further, in any embodiments, the linking member216can be selectively openable so that a surgeon or other user can open the linking member216to facilitate advancing the second extension228through the linking member216. For example and without limitation, the linking member can have a clasp that is selectively openable so that the second extension228or another extension can be advanced through an opening of the linking member216or otherwise coupled with the linking member216. In some embodiments, the linking member216can have a deflectable arm and/or a clasp, for example and without limitation similar to that of a carabineer. In other embodiments, the linking member216can comprise a post such as a t-shaped post that can be received within a slot in the second extension228(for example, a lengthwise slot that extends along all or a portion of the length of the second extension) that can provide a selectively removable rigid connection between the first and second extensions.

Window in Extension Member:

The first extension208, the second extension228, or any other extension of any embodiments of the treatment system200or other treatment systems disclosed herein can have at least one window or slot240extending through a side thereof. With reference toFIG.2L, the at least one slot240can be configured to receive a connecting element244that can be advanced through the slots240of the first and second extensions208,228(and/or any other extensions) toward the first screw210and the second screw230and which can extend between and be used to connect the first screw210to the second screw230in an operable state.

As mentioned, any systems disclosed herein can further include a rigid connecting element244that can be coupled with the head210aof the first screw210and the head230aof the second screw230. The first extension208and the second extension228can be configured to operably receive the connecting element244in the slots or windows240of the first and second extensions208thereof so that the connecting element244can be directed and advanced along the length of the first and second extensions208,228toward the head210aof the first screw210and the head230aof the second screw230. In an operable state, the connecting element244can extend between the first screw210and the second screw230when the first and second screws210,230are implanted in a first and a second vertebra211,213, respectively. Other details regarding coupling of the connecting element244with the first and or second screws210,230are set forth in U.S. Pat. No. 8,721,691, which details are incorporated by reference herein as if fully set forth herein such that any of the features, components, methods, or other details regarding any of the embodiments disclosed in U.S. Pat. No. 8,721,691 can be combined with any of the features, components, methods, or other details of any of the embodiments disclosed herein to form additional embodiments, all of which are part of the present disclosure. Any of the embodiments disclosed herein can be configured to include any of the details, components, methods or otherwise disclosed in U.S. Pat. No. 8,721,691, in combination with any of the details, components, or methods disclosed herein as if fully set forth herein.

An alternative embodiment regarding coupling of the connecting element of any embodiment disclosed herein with the first, second, and/or third second screws can be configured as a pendular mechanism to swing the connecting element from outside the skin through a separate skin incision. This pendular mechanism can be configured to then direct the connecting element from the separate skin incision through the heads of the first screw and then the second screw or vice versa in a sequential manner. This pendular method of inserting the connecting element was popularized by the Medtronic Sextant system for MIS fusion as discussed above. Any of the embodiments of the system and/or method of using the system can be configured for use with the pendular mechanism and can have any of the features of the Medtronic Sextant system for MIS fusion or similar systems or improved versions thereof.

In some embodiments, the screw head210aof the first screw210can have a channel, recess, or other feature formed in the screw head210aof the first screw210that is configured to receive the connecting element244and the screw head230aof the second screw230can have a channel, recess, or other feature formed in the screw head230aof the second screw230that is also configured to receive the connecting element244. The first and second screw heads210a,230acan be configured to selectively secure or lock the connecting element244to the first and second screw heads210a,230aso that the connecting element244will remain in a fixed position after implantation. The connecting element244can, in this configuration, secure the first and second vertebra in the desired relative position.

Third Extension Member:

Any embodiments can further include a third screw (not shown) having a screw head and a third extension configured to be removably coupled with the third screw. The embodiments disclosed herein can further have a third screw having a screw head, a third extension configured to be removably coupled with the third screw, and a handle portion214coupled with a proximal end of the body portion of the third extension, the handle portion214extending away from the proximal end of the body portion of the third extension at an angle. The third extension can have a length that is approximately the same as a length of the first extension. The third extension can have a recess formed therein at the proximal end of the body portion of the third extension that can be configured to receive a portion of an outside surface of the body portion229of the second extension228therein in an operable state. Further, any embodiments of the third extension can also have an additional connecting element coupled with the third extension, the connecting element being configured to allow a removable connection between the third extension and the first extension208and/or the second extension228.

Any of the embodiments disclosed herein can be implanted using any suitable procedures or steps, including any of the procedures or steps described with respect to any other embodiment disclosed herein, including without limitation as described in any of the embodiments disclosed in U.S. Pat. No. 8,721,691, which such procedures or steps are incorporated herein by reference as if fully set forth herein. For example and without limitation, any of the embodiments disclosed herein can be installed or implanted through a skin incision, the method including any combination of the following steps or actions: implanting a first screw210having a first extension208(also referred to as a first guiding element) coupled therewith through the incision and into a first vertebra, wherein the first extension208comprises a body portion extending only to a level of the skin incision or below the level of the skin incision when the first screw210is implanted in the first vertebra. The first extension208can have a handle portion214coupled with and extending away from a proximal end portion of the first extension208. The method can further include implanting a second screw230having a second extension228coupled therewith through the incision and into a second vertebra, wherein the second extension228can have a body portion229extending through the skin incision when the second screw230is implanted in the second vertebra. The method can further include grasping the handle portion214coupled with the first extension208to manipulate the first extension208, coupling a rigid connector (such as connecting element244) with the first screw210and the second screw230to generally fix a position of the first screw210relative to the second screw230. Thereafter, the first and second extensions208,228can be removed from the first and second screws210,230and from the body of the patient.

Some embodiments of the method can further include advancing the second extension228through a rigid linking member that can be positioned adjacent to the skin incision, advancing the second extension228through a rigid linking member (such as linking member216) that can be coupled with a portion of the first extension208, and/or positioning a rigid linking member around the first extension208adjacent to a distal end portion of the handle portion214where the distal end portion of the handle portion214couples with the first extension208. In this configuration, implanting the second screw230having the second extension228coupled therewith through the incision and into a second vertebra can include advancing the second screw230and the second extension228through an opening (such as opening217) in the linking member216.

In some embodiments of the methods disclosed herein, the body portion of the first extension208can include a recess formed in proximal end portion thereof configured to receive a portion of an outside surface of the second extension228therein. Further, the first extension208and the second extension228can each have at least one window extending through a side thereof. Any of the methods disclosed herein can further include coupling a stabilizing element with the screw head210aof the first screw210and the screw head230aof the second screw230.

FIG.2Eshows the first screw210implanted in a first vertebra211. As shown inFIG.2Eand as mentioned above, the device200can be sized and configured such that, when the first screw is fully implanted within the first vertebra211, the first extension208will be positioned fully within the incision206and, hence, fully within the skin of the patient so that substantially no portion of the first extension208extends out of the incision206away from the body of the patient. As shown, the handle portion214can extend away from the incision206so that all, or, in some embodiments, substantially all, of the handle portion214is outside of the body during the procedure. The first guidewire202can be removed thereafter, or can remain in its previous position for subsequent steps.

As shown inFIGS.2F-1and2F-2and as described above, the handle portion214can be used to exert forces on and to move or otherwise manipulate the first extension208and, consequently, the first vertebra211relative to the other vertebrae or otherwise. For example, as shown inFIG.2F-2, a proximal portion214aof the handle portion214can be forced and/or moved in any direction, including a first direction (represented by A1inFIG.2F-2) which can be in a direction away from second vertebrae213which would, in some embodiments and when all components of the system200are implanted, exert a compressive force on the first vertebra211relative to the second vertebra213and move the first vertebra211closer to the second vertebra213. In other methods or procedures, the proximal portion214aof the handle portion214can be forced and/or moved in a direction that is toward the second vertebrae213, so as to, in some embodiments and when all components of the system200are implanted, exert a extension or traction force on the first vertebra211relative to the second vertebra213and move the first vertebra211further away from the second vertebra213. As shown inFIGS.2F-1and2F-2, the proximal end portion214aof the handle portion214has been moved in the first direction A1away from the second vertebra213so that a proximal portion210aof the first extension210is moved in the first direction A1away from the second vertebra213.

With reference toFIGS.2G-1and2G-2, a second extension228that can be removably coupled with a second screw230can be then be advanced through the incision206over a second guidewire204. Importantly, the linking member216can be implanted and positioned relative to the second guidewire204such that the second guidewire204extends through an opening or passageway217of the linking member216. In this arrangement, when the second extension228is advanced along the second guidewire204through the incision206, the second extension228will advance through the opening or passageway217of the linking member216. The second spinal screw230can be implanted into the second vertebra213in this manner, as shown inFIGS.2H-1and2H-2, and the second guidewire can thereafter be removed, as shown inFIG.21, or remain in position for subsequent steps. Thereafter, the extensions, screws, and/or vertebra can be manipulated for compression, decompression, or otherwise, using the handle portion214and the second extension228.

In any embodiments disclosed herein, the incision can approximately be the diameter of a dime, or from approximately ½ to approximately an inch, or from approximately ½ inch to approximately ¾ of an inch. The system can be configured such that the first screw210, the second screw, and a third screw are implanted through the skin incision.

Alternative Shapes of Extensions:

In some embodiments, the first extension208can have a first flat body and a second flat body (such as in some of the embodiments disclosed in U.S. Pat. No. 8,721,691), wherein the first flat body can be spaced apart from the second flat body so as to create a space between the first and second flat bodies.

Further, with reference toFIGS.2L-2T, a rigid connecting element (also referred to as a connecting member or a rod) can be advanced through the extensions (such as, for example and without limitation, through the windows of such screws) and the incision and be secured to the first and second screws using any known or suitable techniques and/or components, such as by using set screws as shown inFIGS.2P-2T. The extensions can thereafter be removed, as shown inFIG.2T.

In addition to the hybrid systems discussed above, additional systems that combine any of the guiding elements discussed above are also possible. For example, a system for rod delivery can include a mixture of one blade and one or more wires on a single screw. Another system for rod delivery can include one tube or tower on a first screw and one or more wire or blade combinations on the second screw. Various combinations of guiding elements that can be used through a single incision are possible.

Certain aspects of the systems, devices, components and/or methods described above or as illustrated with respect toFIGS.2A-2Tare also encompassed by the following numbered embodiments. These numbered embodiments are considered to be directed to systems, devices, components and/or methods that include but are not limited to the embodiments ofFIGS.2A-2T, and thus these numbered embodiments may encompass other embodiments as described throughout this specification.1. A system for stabilizing spinal vertebrae 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 body portion that is configured to be removably coupled with the first screw at a distal end of the body portion of the first extension;a second extension having a body portion that is configured to be removably coupled with the second screw at a distal end of the body portion of the second extension; anda handle portion coupled with or configured to be coupled with a proximal end of the body portion of the first extension, the handle portion extending away from the proximal end of the body portion of the first extension at an angle;wherein:the handle portion is configured to be grasped by a surgeon to enable a surgeon to exert a rotational force on the first extension about at least a centerline axis of the first extension.2. The system of Embodiment 1, wherein the first extension is sized such that a proximal end of the body portion of the first extension extends to a height just below the skin of a patient when the first screw is implanted in a first vertebra.3. The system of Embodiment 1, wherein the first extension is sized such that a proximal end of the body portion of the first extension extends to a height just below the skin of a patient, or to a height level with the skin of a patient, when the first screw is implanted in a first vertebra.4. The system of Embodiment 1, wherein the first extension is sized such that only a proximal end portion of the body portion of the first extension extends through the skin incision when the first screw is implanted in a first vertebra.5. The system of Embodiment 1, wherein the first extension is sized such that no portion of the body portion of the first extension extends through the skin incision when the first screw is implanted in a first vertebra.6. The system of Embodiment 1, wherein the first extension is sized such that the entire body portion of the first extension is positionable below a skin surface of a patient, with only the handle portion extending through the skin incision, when the first screw is implanted in a first vertebra.7. The system of any of the previous Embodiments, wherein the second extension is sized to extend completely through the skin incision when the second screw is implanted in a second vertebra.8. The system of any of the previous Embodiments, wherein the system is configured such that the first and second screws are implanted through the same skin incision.9. The system of any of the previous Embodiments, wherein the system is configured such that the first screw, the second screw, and a third screw are implanted through the same skin incision.10. The system of any of the previous Embodiments, wherein the handle portion is configured to be grasped by a surgeon to enable a surgeon to manipulate the first extension.11. The system of any of the previous Embodiments, wherein the handle portion is configured to be grasped by a surgeon to enable a surgeon to exert a rotational force on the first extension about the centerline axis of the first extension.12. The system of any of the previous Embodiments, wherein the handle portion is removably coupled with the body portion of the first extension.13. The system of any of the previous Embodiments, wherein the handle portion is removably coupled with the body portion of the first extension, the handle portion having an end portion that is receivable in a notch, groove, or other receptacle formed on a side of the body portion of the first extension.14. The system of any of the previous Embodiments, wherein the handle portion is non-removably coupled with the body portion of the first extension.15. The system of any of the previous Embodiments, wherein the handle portion is integrally formed with the body portion of the first extension.16. The system of any of the previous Embodiments, wherein the first extension has a recess formed therein at the proximal end of the body portion of the first extension that is configured to receive a portion of an outside surface of the body portion of the second extension therein in an operable state.17. The system of Embodiment 16, wherein the recess has a shape that generally complements a shape of an outside surface of the body portion of the second extension.18. The system of any of the previous Embodiments, wherein:the first extension has 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 an outside surface of the body portion of the second extension therein in an operable state; andthe handle portion extends away from the body portion of the first extension in a direction that is generally away from the recess.19. The system of any of the previous Embodiments, wherein:the first extension has 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 an outside surface of the body portion of the second extension therein in an operable state;the handle portion is coupled with a first side of the body portion of the first extension; andthe recess is formed on a second side of the body portion of the first extension that is opposite to the first side of the body portion of the first extension.20. The system of any of the previous Embodiments, wherein the handle portion attaches to the body portion of the first extension adjacent to a recess formed in the body portion of the first extension.21. The system of any of the previous Embodiments, wherein the body portion of the first extension has an adjustable length.22. The system of any of the previous Embodiments, wherein each of the first and second extensions has a fixed length.23. The system of any of the previous Embodiments, wherein the first and second body portions are cylindrically shaped.24. The system of any of the previous Embodiments, wherein the first extension comprises a first flat body and a second flat body, wherein the first flat body is spaced apart from the second flat body so as to create a space between the first and second flat bodies.25. The system of any of the previous Embodiments, further comprising a rigid linking member having an opening therein, the linking member being configured to surround a proximal end of the body portion of the first extension and the body portion of the second extension in an operable state and to couple the first and second extensions together.26. The system of any of the previous Embodiments, further comprising a rigid linking member having an opening therein configured to surround a proximal end of the body portion of the first extension and the body portion of the second extension in an operable state, the linking member configured to provide a loose connection between the first and second extensions.27. The system of either one of Embodiments 25-26, wherein the linking member is selectively openable.28. The system of any of the previous Embodiments, further comprising:a rigid connecting element;a first receiving element coupled with the first screw head; anda second receiving element coupled with the second screw head;wherein the first and second receiving elements are configured to operably receive the connecting element that, in an operable state, extends between the first and second receiving elements when the first and second screws are implanted in a first and a second vertebra, respectively.29. The system of any of the previous Embodiments, wherein the first screw is configured to be implanted in a first vertebra and the second screw is configured to be implanted into a second vertebra.30. The system of any of the previous Embodiments, wherein the first screw with the first extension and the second screw with the second extension are configured to be delivered into the first and second vertebra, respectively, through the skin incision, which is a minimally invasive skin incision.31. The system of any of the previous Embodiments, comprising at least one handle portion coupled with the body portion of the second extension.32. The system of any of the previous Embodiments, comprising at least one handle portion coupled with the body portion of the second extension.33. The system of any of the previous Embodiments, further comprising a third screw having a screw head and a third extension configured to be removably coupled with the third screw.34. The system of any of the previous Embodiments, further comprising:a third screw having a screw head;a third extension configured to be removably coupled with the third screw; anda handle portion coupled with a proximal end of the body portion of the third extension, the handle portion extending away from the proximal end of the body portion of the third extension at an angle.35. The system of Embodiment 34, wherein the third extension has a length that is approximately the same as a length of the first extension.36. The system of any of Embodiments 34-35, wherein the third extension has a recess formed therein at the proximal end of the body portion of the third extension that is configured to receive a portion of an outside surface of the body portion of the second extension therein in an operable state.37. The system of any of the previous Embodiments, wherein the first extension has at least one window extending through a side of the body portion thereof, the at least one window configured to receive a connecting element that is configured to extend between the first and second screws in an operable state.38. The system of any of the previous Embodiments, wherein the first extension is shorter than the second extension.39. The system of any of the previous Embodiments, wherein the second extension has at least one window extending through a side of the body portion thereof, the at least one window of the second extension configured to receive a connecting element that is configured to extend between the first and second screws in an operable state.40. A method of performing spinal stabilization through a skin incision, the method comprising:implanting a first screw having a first guiding element coupled therewith through the incision and into a first vertebra, wherein the first guiding element comprises a body portion extending only to a level of the skin incision or below the level of the skin incision when the first screw is implanted in the first vertebra, wherein a handle portion is coupled with and extends away from a proximal end portion of the first guiding element either before or after the first screw is implanted in the first vertebra;implanting a second screw having a second guiding element coupled therewith through the incision and into a second vertebra, wherein the second guiding element comprises a body portion extending through the skin incision when the second screw is implanted in the second vertebra;grasping the handle portion coupled with the first guiding element to manipulate the first guiding element;coupling a rigid connector with the first and second screws to generally fix a position of the first screw relative to the second screw; andremoving the first and second guiding elements from the first and second screws, respectively.41. The method of Embodiment 40, further comprising advancing the second guiding element through a rigid linking member that is positioned adjacent to the skin incision.42. The method of Embodiment 40, further comprising advancing the second guiding element through a rigid linking member that also surrounds a portion of the first guiding element.43. The method of Embodiment 40, further comprising positioning a rigid linking member around the first guiding element adjacent to a distal end portion of the handle portion, wherein implanting the second screw having the second guiding element coupled therewith through the incision and into a second vertebra comprises advancing the second screw and the second guiding element through an opening in the linking member.44. The method of any one of Embodiments 40-43, wherein the linking member is a selectively openable linking member.45. The method of Embodiment 44, wherein the linking member comprises a carabineer or is otherwise configured to be selectively openable.46. The method of any one of Embodiments 40-45, wherein a distal portion of the handle portion extends through the skin incision to couple with the first guiding element when the first screw is implanted in the first vertebra.47. The method of any one of Embodiments 40-46, wherein the body portion of the first guiding element comprises a recess formed in proximal end portion thereof configured to receive a portion of an outside surface of the second guiding element therein.48. The method of any one of Embodiments 40-47, wherein the first guiding element has at least one window extending through a side of the first guiding element.49. The method of Embodiment 48, wherein the second guiding element has at least one window extending through a side of the second guiding element.50. The method of any one of Embodiments 40-49, further comprising coupling a stabilizing element a head portion of each of the first and second screws.51. A guiding assembly for use in spinal surgery, comprising:a guiding element comprising an elongate body portion, a distal end of the elongate body portion configured to be removably coupled with a screw and a proximal end of the body portion configured to be positioned at or below a level of a patient's skin; anda handle portion coupled with or configured to be coupled with a proximal end of the body portion, the handle portion extending away from the proximal end of the body portion of at an angle;wherein the guiding element has a recess formed therein at the proximal end of the body portion that is configured to receive a portion of an outside surface of another guiding element; andwherein the handle portion extends away from the proximal end of the body portion in a direction away from the recess.
Systems, Devices and Methods ofFIGS.3A-3O

Additional embodiments of a system (e.g., system300) that can be used for stabilizing or treating spinal vertebrae through a skin incision S are disclosed below. In any embodiments disclosed herein, any components, features, or other details of the system300can have any of the components, features, or other details of any other system embodiments disclosed herein or be used according to any of the steps of any other method embodiments disclosed herein, including without limitation any of the embodiments of the system200or methods of use thereof described above, in any combination with any of the components, features, or details of the system300or methods of use disclosed below. Similarly, any components, features, steps, or other details of any of the other system or method embodiments disclosed herein can have any of the components, features, steps, or other details of any embodiments of the system300or methods of use thereof disclosed herein in any combination with any of the components, features, or details of the system.

Some embodiments of the system300for stabilizing spinal vertebrae through a skin incision S can include a first screw302having a first screw head, a second screw304having a second screw head, a first extension310(also referred to herein as a first tower) having a distal portion310aand a proximal portion310b, the first extension310being configured to be removably coupled with the first screw302at a distal end of the first extension310, and a second extension320(also referred to herein as a second tower) having at least one proximal portion320b, the second extension320configured to be removably coupled with the second screw304at a distal end of the second extension320. In any embodiments disclosed herein, the extension can be referred to as an extension, a guiding element, a tower, or using other similar terms.

In some embodiments, the first extension310can have a two or more proximal portions310bextending away from the distal portion310aof the first extension310at a variety of angles. In some embodiments, the first extension310can removably couple with the first screw302such that, when the first extension310is coupled with the first screw302, an axial centerline C of the distal portion310aof the first extension310is approximately collinear with an axial centerline C of the first screw302. Further, the second extension320can removably couple with the second screw304such that, when the second extension320is coupled with the second screw304, an axial centerline C of the distal portion310aof the second extension320is approximately collinear with an axial centerline C of the second screw304. In some embodiments, the first extension310can be shorter than the second extension320, or longer than the second extension320, or have approximately the same length as the second extension320.

In some embodiments, the angle between the proximal portion310band distal portion310acan be adjustable or the angle between the proximal portion320band distal portion320acan be adjustable. A common mechanism for adjustability is a gear or ratchet mechanism. In this way, the proximal portion310bor320bcan be angled away from the centerline of the distal portion of the respective screw. By adjusting the angle, there may be more room to place the rod and locking caps. Also, by adjusting the angle, it may be easier for a surgeon to grip both proximal portions of the towers in order to squeeze the two proximal portions of the two screws in order to compress the heads of screws when locking the caps onto the rod connecting the screw heads. In another embodiment, proximal portions310band320bcan be detachable from the distal portions310aand320a. In this manner, proximal portions with different angles in relation to centerline of the respective distal portions can be switched as needed and reconnected to the distal portions of the extensions.

Any embodiments of the system300disclosed herein can be configured such that the first screw302and the second screw304are implanted through the same skin incision S. Additionally, any embodiments of the system300can be configured such that the first screw302, the second screw304, and a third screw can be implanted through the same skin incision S.

In some embodiments, the proximal portion310bof the first extension310can extend at an angle away from the axial centerline C of the distal portion310aof the first extension310such that the proximal portion310bof the first extension310is not approximately collinear with the distal portion310aof the first extension310. Further, the proximal portion310bof the first extension310can be configured such that, in an operable state, the proximal portion310bof the first extension310also can extend at an angle away from the axial centerline C of the distal portion of the second extension320so that the proximal portion310bof the first extension310forms an acute angle A relative to the distal portion of the second extension320, as shown inFIG.3A. In some embodiments, the angle A can be 50° (or approximately 50°), or from 40° (or approximately 40°) or less to 70° (or approximately 70°) or more.

In some embodiments, the first extension310can be sized and configured such that, in an operable state, the proximal portion310bof the first extension310can extend away from the skin incision S toward the surgeon. In some embodiments, the distal portion310aof the first extension310can extend away from the first screw302to a height just below the skin incision S, or to a height level with the skin of a patient, when the first screw302is fully implanted in a first vertebra. Further, the proximal portion310bof the first extension310can be configured to be grasped by a surgeon to enable a surgeon to exert a rotational force on the first extension310about at least the axial centerline C of the distal portion310aof the first extension310and/or a torque force on the first extension310so as to cause the first extension310to rotate about an axis that is perpendicular to an axial centerline C of the distal portion310aof the first extension310. In some embodiments, the first extension310can be sized such that only the proximal portion310bof the first extension310is outside of the skin incision S when the first screw302is implanted in a first vertebra. In any embodiments, the second extension320can be sized to extend completely through the skin incision S when the second screw304is implanted in a second vertebra.

The proximal portion310bof the first extension310can have a length that is approximately the same as a length of the distal portion310aof the first extension310, or can have a length that is at least 80% or less of a length of the distal portion310aof the first extension310. In some embodiments, the proximal portion310bof the first extension310can be removably coupled with the distal portion310aof the first extension310. In other embodiments, the proximal portion310bof the first extension310can be non-removably coupled with the distal portion310aof the first extension310. For example and without limitation, the proximal portion310bof the first extension310can be integrally formed with the body portion of the first extension310. In some embodiments, the proximal portion of the first extension310bor second extension320bcan be coupled with the distal portion of the respective first or second extension310aor320bthrough an adjustable coupling that allows for adjustable angle between the proximal or distal portions of the respective extension. An example of such a coupling would be a hinge.

With reference toFIGS.3A-3B, at least the distal portion310a, the proximal portion310bof the first extension310, and/or the second extension320can have a tubular or half-tubular shape. Additionally, the first extension310can have a cutout324formed through a wall portion326of the first extension310, the cutout324being configured to receive a portion of an outside surface320aof the second extension320therein in an operable state, as shown inFIG.3A, for example. In some embodiments, the cutout324can extend at least through a proximal end310cof the distal portion310aof the first extension310. The cutout324can extend entirely through the first extension310such that, in an operable state, the second extension320and the screw coupled with the extension320can pass entirely through the cutout324.

In some embodiments, the cutout324can extend entirely through the first extension310such that, in an operable state, the second extension320can pass entirely through the cutout324and such that the wall portion326of the first extension310completely and continuously surrounds an outside surface320aof a portion of the second extension320. Further, some embodiments of the cutout324can be shaped such that a distal edge330of the cutout324is configured to contact an outside surface320aof the second extension320in an operable state so that the second extension320can be rotated about the distal edge330of the cutout324relative to the first extension310. Some embodiments of the cutout324can have an ovular shape.

With reference toFIGS.3B-3D, the cutout324can have a notch334at a proximal end324aof the cutout324, the notch334of the cutout324configured to permit a passage of at least a portion of a connecting element350to pass through the notch334during the deployment of the connecting element350. In some embodiments, the cutout324can have a notch334at a proximal end thereof, the notch334of the cutout324configured to permit a passage of at least a portion of a connecting element350and a portion of a connecting element implantation device370to pass through the notch334. A width of the notch334can be less than a width of an outside surface320aof the second extension320so that the outside surface320aof the second extension320is prevented from extending into the notch334. A width of the notch334can be less than a width of the cutout324so that the cutout324defines a proximal edge332that is configured to contact an outside surface320aof the second extension320so that the second extension320can be rotated about the proximal edge relative to the first extension310when at least a proximal portion310bof the first extension310is moved toward a proximal portion320bof the second extension320. In some embodiments, the cutout324can be adjacent to a proximal end of the distal portion310aof the first extension310and a distal end of the proximal portion310bof the first extension310. Further, some embodiments of the first extension310can have a distal notch334formed at a distal end of the first extension310, the distal notch334configured to permit a passage of at least a portion of a connecting element350to pass through the distal notch354and into the heads of the screws.

In some embodiments, at least the distal portion310aof the first extension310can have an adjustable length. Further, some embodiments of the first extension310and the second extension320can be cylindrically shaped. Other embodiments can have any other desired cross-sectional shape, including a generally square shape, a triangular cross-sectional shape, on ovular cross-sectional shape, a polygonal cross-sectional shape, or any combination of the foregoing. The proximal portion310bof the first extension310can have a cross-sectional profile that can have a curved shape, as shown in the figures. Further, the proximal portion310bof the first extension310can have a cross-sectional profile that can have a semi-circular tubular shape. In some embodiments, the proximal portion310bof the first extension310can have a cross-sectional profile that is approximately the same as one-half of the distal portion310aof the first extension310. In some embodiments, the proximal portion310bof the first extension310can have a planar shape.

As mentioned, any of the embodiments of the system300disclosed herein can have a rigid connecting element350(that can be implanted using any desired shape and configuration of a connecting element implantation device, such as the embodiment of the connecting element implantation device shown inFIGS.3E-3F, a first receiving element coupled with the head of the first screw302, and a second receiving element coupled with the head of the second screw304. With reference toFIGS.3L-3M, the first and second receiving elements can be configured to operably receive the connecting element350that, in an operable state, can extend between the first and second receiving elements when the first screw302and the second screw304are implanted in a first and a second vertebra, respectively. The first screw302can be configured to be implanted in a first vertebra and the second screw304is configured to be implanted into a second vertebra.

In some embodiments, the first extension310can have at least one window or slot358extending through a side of the body portion thereof, the at least one slot358configured to receive a connecting element350or configured to permit a passage of a connecting element350therethrough, the connecting element350being configured to extend between the first screw302and the second screw304in an operable state. Further, the second extension320can have at least one slot or window360extending through a side of the body portion of the second extension320, the at least one slot360of the second extension320configured to receive a connecting element350that is configured to extend between the first screw302and the second screw304in an operable state.

Some embodiments of methods for treating a spinal defect include implanting the first screw302that is coupled with the first extension310through the incision into a first vertebra, advancing the second extension320that is coupled with the second screw304through the cutout324formed in the first extension310and implanting the second screw304into a second vertebra, and moving a proximal end of the proximal portion310bof the first extension310toward a proximal end of the second extension320to cause the outside surface320aof the second extension320to contact at least proximal edge332of the cutout324or a distal edge351(shown inFIG.3A) or other portion of the surface of the cutout324. In some embodiments, further moving the proximal end of the proximal portion310bof the first extension310toward a proximal end of the second extension320can cause the outside surface320aof the second extension320to rotate about at least the distal edge330of the cutout324and cause the distal end of the first extension310to move toward the distal end of the second extension320, thereby moving the first vertebra toward the second vertebra. In some embodiments, the method can further include coupling a rigid connector350with the first screw302and the second screw304to generally fix a position of the first screw302relative to the second screw304.

With reference toFIGS.3E-3G, an embodiment of a connecting element insertion device370is shown. In any embodiments disclosed herein, the connecting element insertion device370can have a handle371, a main stem or arm372coupled with the handle371, and a head portion374coupled with the main stem372. In some embodiments, the main stem can have a flexible joint378in a middle portion thereof. With reference toFIGS.3E and3F, the joint378can be configured to flex or bend so that a distal portion of the stem372can rotate relative to a proximal portion of the main stem372. In some embodiments, the joint378can permit the connecting element350to rotate. The joint378can be a separate flexible joint or element (such as a component comprising plastic, rubber, and/or nitinol) that is added to the shaft372, or can be formed by other methods such as a flexible cut outs in the tube of the shaft372. The flexibility of the joint378can permit the tip of the connecting element350to enter approximately vertically in the axis of the first extension with the solid wall. Then the tip of the connecting element150can be slid down the wall on the way to the screw head towards passage354, as shown inFIGS.3H-3L.

In some embodiments, the connecting element insertion device370can be shorter than conventional rod inserters or devices for inserting connecting elements. The connecting element insertion device370can be shorter so that the main stem372of the connecting element insertion device370can pass through a standard extensions or towers. Conventional rod inserters were too long and could not pass within standard extensions or towers. In order to do this, a connection member380at the top of the main shaft372connecting element insertion device370can have two, three, or more holes or connection interfaces that a handle such as handle371can connect with. Each of the holes can be configured to permit the handle to extend away from the connection member380at a different orientation.

In some embodiments, the center hole that can pass down the center of the shaft372of the connecting element insertion device370can be for a screw driver that can tighten or loosen a screw that secures the connecting element350(also referred to herein as a rod) in a head portion374of the connecting element insertion device370. The other two holes can be threaded holes for handles such as handle371that can attach to the connecting member380from the front side and/or the back side. The front side handle371can be inserted first and can be used to lower the connecting element350into the extension or tower as the connecting element350passes from a vertical orientation down to the head of the first screw. As the connecting element350starts to turn horizontally into the seat of the heads of both screws, the main shaft372of the connecting element insertion device370can 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 threaded hole so that the connecting element insertion device370can be held and stabilized on the other side of the extension or tower. Lastly, in some embodiments, though not required, the main shaft372of the connecting element insertion device370shaft can be flexible. This flexibility can be either a hinge or flexible as shown here as cutouts in the wall of the shaft372. Any suitable methods or materials to make the shaft372flexible can be used, including without limitation using flexible materials such as plastic, rubber, or metals such as nitinol.

With reference toFIG.3J, this figure shows the connecting element350being inserted into the seat of the heads of both screws. The connecting element350is transitioning from vertical orientation to the horizontal orientation. The flexible portion378of the shaft372can be bent as shown inFIG.3J. One beneficial way to insert the connecting element350is to keep the tip of the connecting element350in contact with the midline wall of the first extension or tower. By keeping the tip of the connecting element350in contact with the wall, the surgeon can feel the position of the connecting element350until it hits the bottom of the tower and enters the seat of the head of the screw. The insertion device370can then be rotated to the other side of the extension or tower to allow the connecting element350to sit into the heads of both screws. The insertion device370can then be moved to the other side of the extension or tower so that the cap (such as cap390) can be placed through the extension or tower to secure the connecting element350to the screw attached to the screw.

Some embodiments of the connecting element insertion device370can have a second property. The connecting element insertion device370can be short enough to pass under the top part of the tower of the second screw that holds the two “blades” or sides of the tower or extension together. A second handle371can screw into the connection member380from the other side of the extension (such as is shown inFIG.3K) after the connecting element insertion device370passes through between the blades of the extension or through a slot in the extension. At this point, the first handle371of the rod holder can be removed. In any embodiments, as has been described, the handle371of the insertion device370can move from one side of the extension or tower to the other side. Alternatively, in some embodiments, a second screw can be open at the top (distal end) like open blades. Then the handle371can pass easily. The blades can be locked together after that by a cap or screw cap. After the connecting element350has been coupled with the screws or screw heads, in any embodiments, disclosed herein, a fastener such as the insert screw or cap390shown inFIGS.3L-3Mcan be advanced through the extension and coupled with the insert or the seat that supports the connecting element350.

With reference toFIG.3L, the insertion device370is now positioned at the other side of the extension or tower with the second handle373inserted and the first handle371removed. The cap390can be inserted through the tower and be secured onto the L5 screw, which can be connected to the extension or tower. The screw can be final tightened to the final torque. It is during the final tightening process which cap390can be tightened to a final torque. This final torque tightening requires a counter torque mechanism for the screw head while the cap is being tightened to the final torque so that the whole construct does not rotate during final tightening. The angled proximal portion of the first extension of the first screw310bserves as a handle for counter torque. Thus the extension310and302serves as tower for screw head alignment, for creating a path for connecting element (rod)350insertion, for the conduit for locking cap390insertion, for compression of the screw heads when the tightening caps390are final tightened onto the connecting element350, and as counter torque when the caps390are final tightened. All of these steps usually entail separate tools to be inserted and removed at the appropriate step of the process. However in the present invention, all these steps are incorporated and performed by the same extensions310and320. In this way the surgery is simplified, shortened, and streamlined. Finally the insertion device370can be disconnected from the connecting element350by unscrewing the internal screw that secures the connecting element350to the head of the insertion device370.

In any embodiments disclosed herein, the system can include generally nonflexible structures (e.g., the extensions) attached to the screws which pass through each other and then interact so that the extensions can allow compression and reduction without additional tools being inserted into the patient. This saves time and still maintains a small incision for faster recovery. Additionally, any of the embodiments disclosed herein, the components of the system can be configured for use in robotic surgery. Because the extensions are generally rigid, these extensions can be secured and held or attached to robotic arms that then can know the exact position and orientation of the heads of each screw. Knowing this information allows for the robotic insertion of a connecting element into the seat of the screw heads.

In any embodiments disclosed herein, the one or more screws can be implanted using other means, and the extensions or guide elements can be coupled with the screw heads or other components coupled with the screws after the screws have been implanted. In any embodiments disclosed herein, the extensions, guide elements, and/or towers can be used with any of the devices or components shown and described in relation toFIGS.1A-1Z, including without limitation the wires140a,140b, the screws110, the inserts116a, and/or the screw heads114. For example and without limitation, in any embodiments, the first and second extensions310,320can be passed over any of the wires140a,140band secured to the screws110or screw heads114so that the first and second extensions310,320are coupled with the screws110for further procedures as disclosed herein or otherwise.

Certain aspects of the systems, devices, components and/or methods described above or as illustrated with respect toFIGS.3A-3Oare also encompassed by the following numbered embodiments. These numbered embodiments are considered to be directed to systems, devices, components and/or methods that include but are not limited to the embodiments ofFIGS.3A-3O, and thus these numbered embodiments may encompass other embodiments as described throughout this specification.1. A system for stabilizing spinal vertebrae 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 with the first screw at a distal end of the first extension; anda second extension having at least a proximal portion, the second extension configured to be removably coupled with the second screw at a distal end of the second extension;wherein:the first extension is configured to removably couple with the first screw such that, when the first extension is coupled with the first screw, an axial centerline of the distal portion of the first extension is approximately collinear with an axial centerline of the first screw;the second extension is configured to removably couple with the second screw such that, when the second extension is coupled with the second screw, an axial centerline of the distal portion of the second extension is approximately collinear with an 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 approximately collinear with the distal portion of the first extension;and the proximal portion of the first extension is configured such that, in an operable state, the proximal portion of the first extension also extends at an angle away from the axial centerline of the proximal portion of the second extension so that the proximal portion of the first extension forms an acute angle relative to the proximal portion of the second extension.2. The system of Embodiment 1, wherein the first extension is sized and configured such that, in an operable state, the proximal portion of the first extension extends away from a skin incision toward a surgeon.3. The system of Embodiment 1 or 2, wherein the distal portion of the first extension extends away from the first screw to a height just below the skin incision, or to a height level with the skin of a patient, when the first screw is fully implanted in a first vertebra.4. The system of any one of the previous Embodiments, wherein the proximal portion of the first extension is configured to be grasped by a surgeon to enable a surgeon to exert a rotational force on the first extension about at least the axial centerline of the distal portion of the first extension and/or a torque force on the first extension so as to cause the first extension to rotate about an axis that is perpendicular to an axial centerline of the distal portion of the first extension.5. The system of any one of the previous Embodiments, wherein the first extension is sized such that only the proximal portion of the first extension is outside of a skin incision when the first screw is implanted in a first vertebra.6. The system of any one of the previous Embodiments, wherein the second extension is sized to extend completely through a skin incision when the second screw is implanted in a second vertebra.7. The system of any one of the previous Embodiments, wherein the system is configured such that the first and second screws are implanted through the same skin incision.8. The system of any one of the previous Embodiments, wherein the system is configured such that the first screw, the second screw, and a third screw are implanted through the same skin incision.9. The system of any one of the previous Embodiments, wherein the proximal portion of the first extension has a length that is approximately the same as a length of the distal portion of the first extension.10. The system of any one of the previous Embodiments, wherein the proximal portion of the first extension has a length that is at least 80% of a length of the distal portion of the first extension.11. The system of any one of the previous Embodiments, wherein the proximal portion of the first extension is removably coupled with the distal portion of the first extension.12. The system of any one of the previous Embodiments, wherein the proximal portion of the first extension is non-removably coupled with the distal portion of the first extension.13. The system of any one of the previous Embodiments, wherein the proximal portion of the first extension is integrally formed with the body portion of the first extension.14. The system of any one of the previous Embodiments, wherein at least the proximal portions of the first extension and the second extensions have a tubular shape.15. The system of any one of the previous Embodiments, wherein the first extension has a cutout formed through a wall portion of the first extension, the cutout being configured to receive a portion of an outside surface of the second extension therein in an operable state.16. The system of Embodiment 15, wherein the cutout extends at least through a proximal end of the distal portion of the first extension.17. The system of Embodiment 15, wherein the cutout extends entirely through the first extension such that, in an operable state, the second extension can pass entirely through the cutout.18. The system of Embodiment 15, wherein the cutout extends entirely through the first extension such that, in an operable state, the second extension can pass entirely through the cutout and such that the wall portion of the first extension surrounds an outside surface of a portion of the second extension.19. The system of any one of Embodiments 15-18, wherein the cutout is shaped such that a distal edge of the cutout is configured to contact an outside surface of the second extension in an operable state so that the second extension can be rotated about the distal edge of the cutout relative to the first extension.20. The system of any one of Embodiments 15-19, wherein the cutout has an ovular shape.21. The system of any one of Embodiments 15-20, wherein the cutout has a notch at a proximal end of the cutout, the notch of the cutout configured to permit a passage of at least a portion of a connecting element to pass through the notch.22. The system of any one of Embodiments 15-21, wherein the cutout has a notch at a proximal end thereof, the notch of the cutout configured to permit a passage of at least a portion of a connecting element and a portion of a connecting element implantation device to pass through the notch.23. The system of Embodiment 22, wherein a width of the notch is less than a width of an outside surface of the second extension so that the outside surface of the second extension is prevented from extending into the notch.24. The system of Embodiment 22, wherein a width of the notch is less than a width of the cutout so that the cutout defines a proximal edge that is configured to contact an outside surface of the second extension so that the second extension can be rotated about the proximal edge relative to the first extension when at least a proximal end of the first extension is moved toward a proximal end of the second extension.25. The system of any one of Embodiments 15-24, wherein the cutout is adjacent to a proximal end of the distal portion of the first extension and a distal end of the proximal portion of the first extension.26. The system of any one of the previous Embodiments, wherein the first extension has a distal notch formed at a distal end of the first extension, the distal notch configured to permit a passage of at least a portion of a connecting element to pass through the distal notch.27. The system of any one of the previous Embodiments, wherein at least the distal portion of the first extension has an adjustable length.28. The system of any one of the previous Embodiments, wherein the first extension and the second extension are cylindrically shaped.29. The system of any one of the previous Embodiments, wherein the proximal portion of the first extension has a cross-sectional profile that has a curved shape.30. The system of any one of the previous Embodiments, wherein the proximal portion of the first extension has a cross-sectional profile that has a semi-circular tubular shape.31. The system of any one of the previous Embodiments, wherein the proximal portion of the first extension has a cross-sectional profile that is approximately the same as one-half of the distal portion of the first extension.32. The system of any one of the previous Embodiments, wherein the proximal portion of the first extension has a planar shape.33. The system of any one of the previous Embodiments, further comprising:a rigid connecting element;a first receiving element coupled with the first screw head; anda second receiving element coupled with the second screw head;wherein the first and second receiving elements are configured to operably receive the connecting element that, in an operable state, extends between the first and second receiving elements when the first and second screws are implanted in a first and a second vertebra, respectively.34. The system of any one of the previous Embodiments, wherein the first screw is configured to be implanted in a first vertebra and the second screw is configured to be implanted into a second vertebra.35. The system of any one of the previous Embodiments, comprising more than one discrete proximal portions extending away from the distal portion of the first extension.36. The system of any one of the previous Embodiments, wherein the first extension has at least one window extending through a side of the body portion thereof, the at least one window configured to receive a connecting element that is configured to extend between the first and second screws in an operable state.37. The system of any one of the previous Embodiments, wherein the first extension is shorter than the second extension.38. The system of any one of the previous Embodiments, wherein the second extension has at least one window extending through a side of the body portion thereof, the at least one window of the second extension configured to receive a connecting element that is configured to extend between the first and second screws in an operable state.39. A method of stabilizing spinal vertebrae, comprising:implanting a first screw that is coupled with a first extension through an incision into a first vertebra;advancing a second extension that is coupled with a second screw through a cutout formed in the first extension and implanting the second screw into a second vertebra;moving a proximal end of a proximal portion of the first extension toward a proximal end of the second extension to cause an outside surface of the second extension to contact at least a distal edge of the cutout; andfurther moving the proximal end of the proximal portion of the first extension toward a proximal end of the second extension to cause the outside surface of the second extension to rotate about at least a distal edge of the cutout and to cause a distal end of the first extension to move toward a distal end of the second extension, thereby moving the first vertebra toward the second vertebra.40. The method of Embodiment 39, further comprising coupling a rigid connector with the first screw and the second screw to generally fix a position of the first screw relative to the second screw.
Systems, Devices and Methods ofFIGS.4A-4T

Additional embodiments of a system400for stabilizing spinal vertebrae through a skin incision S will now be described. In any embodiments disclosed herein, any components, features, or other details of the system400can have any of the components, features, or other details of any other system embodiments disclosed herein or be used according to any of the steps of any other method embodiments disclosed herein, including without limitation any of the embodiments of the system200or300or methods of use thereof described above, in any combination with any of the components, features, or details of the system400or methods of use disclosed below. Similarly, any components, features, steps, or other details of any of the other system or method embodiments disclosed herein can have any of the components, features, steps, or other details of any embodiments of the system400or methods of use thereof disclosed herein in any combination with any of the components, features, or details of the system.

In some embodiments, the system400can include a first screw402having a first screw head, a second screw404having a second screw head, a first extension410configured to be removably coupled with the first screw402at a distal end410aof the first extension410, the first extension410having a first wall414and a first passageway416extending through the first extension410along an axial centerline C of the first extension410such that the first wall414of the first extension410at least partially surrounds the first passageway416. In some embodiments, the first screw402can be configured to be implanted in a first vertebra403and the second screw404can be configured to be implanted into a second vertebra405. The system400can further have a second extension420configured to be removably coupled with the second screw404at a distal end420aof the second extension420, the second extension420having a second wall428(also referred to herein as a wall) and a second passageway426extending through the second extension420along an axial centerline C of the second extension420such that the second wall428of the second extension420at least partially surrounds the second passageway426.

The first extension can further have an opening432(also referred to herein as a first opening) extending through the first wall414of the first extension410. The opening432and the first wall414of the first extension410adjacent to the opening432can be sized and configured such that the second extension420can be advanced through the opening432in an operable state so that the second extension420or an axial centerline thereof is restrained or supported at an acute angle A (as shown inFIG.4A) relative to an axial centerline C of the first extension410.

In some embodiments, the first extension410can be removably coupleable with the first screw402such that, when the first extension410is coupled with the first screw402, the axial centerline C of the first extension410is approximately collinear with an axial centerline C of the first screw402and wherein the second extension420is removably coupleable with the second screw404such that, when the second extension420is coupled with the second screw404, an axial centerline C of the second extension420is approximately collinear with an axial centerline C of the second screw404. In any embodiments disclosed herein, the first extension410and the second extension420can be generally cylindrically shaped 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, on ovular cross-sectional shape, a polygonal cross-sectional shape, or any combination of the foregoing. Further, some embodiments of the first extension410and/or the second extension420can be generally rigid.

Further, in some embodiments, at least a distal portion410cof the first extension410and/or the second extension420can have an adjustable length. As with other embodiments, the first extension410can be sized and configured such that, in an operable state, a proximal portion410bof the first extension410can extend away from the skin incision S toward the surgeon.

In some embodiments, an inside size of the first wall414of the first extension410adjacent to the opening432in the first extension410can be greater than an outside size of at least a portion of the second wall428of the second extension420such that at least a portion of the second extension420can be passed through the opening432of the first extension410at an acute angle A relative to the axial centerline C of the first extension410and be at least partially surrounded by the first wall414of the first extension410. Further, a proximal portion410bof the first extension410can have an inside cross-sectional size that is greater than an inside cross-sectional size of a distal portion410cof the first extension410. Further, in some embodiments, the inside cross-sectional size of the proximal portion410bof the first extension410can also be greater than an outside cross-sectional size of at least a distal portion of the second extension420so that at least the distal portion of the second extension420can be advanced completely through the opening432of the first extension410.

In some embodiments, the opening432in the first extension410can pass through the first wall414of the first extension410at an angle that is acute relative to the axial centerline C of the first extension410. In some embodiments, the opening432can include a first cutout434in a first side436of the first wall414and a second cutout440in a second side442of the first wall414, wherein the second side442of the first wall414is opposite to the first side436of the first wall414. The second cutout440can be separate from the first cutout434such that the first cutout434and the second cutout440are not overlapping or connected. Further, the second cutout440can be positioned closer to a distal end410aof the first extension410than the first cutout434.

In some embodiments, the first cutout434can extend in a distal direction from a proximal end410dof the first extension410such that the first wall414of the first extension410does not form a complete or continuous enclosure around the first passageway416at the proximal end410dof the first extension410. In some embodiments, the first cutout434can remove at least approximately 40% of the first wall414of the first extension410at least the proximal end410dof the first extension410. Some embodiments of the first cutout434can extend along a length of the first extension410that is at least approximately 30% of a total length of the first extension410, or that is at least approximately 40% of a total length of the first extension410. Further, in some embodiments, a distal edge446of the first cutout434can be planar and can be angled downwardly toward the distal end410aof the first extension410.

In some embodiments, a proximal portion440aof the second cutout440can overlap a distal portion434aof the first cutout434in an axial direction. Further, the second cutout440can be positioned between a proximal end410dand the distal end410aof the first extension410such that a proximal portion440aof the second cutout440is spaced apart from the proximal end410dof the first extension410and a distal portion440bof the second cutout440is spaced apart from the distal end410aof the first extension410. In some embodiments, the second cutout440can remove at least approximately 40% of the first wall414of the first extension410in at least a middle portion of the first extension410. Further, the second cutout440can extend along a length of the first extension410that is at least approximately 30% of a total length of the first extension410.

The second cutout440can extend along a length of the first extension410that is at least approximately 40% of a total length of the first extension410. Further, in some embodiments, a proximal edge448of the second cutout440can be curved or planar. In some embodiments, a distal edge450of the second cutout440can be planar and can be angled downwardly toward the distal end410aof the first extension410. Further, in some embodiments, one or more projections454adjacent to the distal edge450of the second cutout440can provide a surface or a shoulder against which the second extension420can contact to limit a range of rotation of the second extension420relative to the first extension410. In some embodiments the projection454is a sloped cutout instead of a projection and allows closer approximation between the two screws and two extension, for instance in the case that there is severe lordosis and the angle A between neighboring screws is severe.

In some embodiments, the first extension410and the second extension420can be configured such that, in an operable state wherein the second extension420is advanced through the opening432in the first extension410, moving a proximal end of the first extension410either toward or away from a proximal end of the second extension420can cause the second extension420to hinge and/or rotate relative to first extension410so as to cause the distal end of the second extension420to move toward or away from the distal end410aof the first extension410, respectively. For example and without limitation, moving a proximal end of the first extension410either toward or away from a proximal end of the second extension420can cause the second extension420to hinge and/or rotate about an edge of the opening432in the first extension410so as to cause the distal end of the second extension420to move toward or away from the distal end410aof the first extension410, respectively.

The hinge effect can be created in some embodiments due to the physical barrier of having extension410passing through an opening434within the other extension430. In essence extension410can be trapped within the hole (topologically defined) created by the opening or cutouts in extension430. Alternatively, an actual hinge can exist between the extensions430and410by having complementary protrusions near the point of contact to make the such as a ball and socket hinge. Some embodiments of the system400can be configured to generate a hinge effect by imposing a constraint imposed on the movement between extension410and430. An external ring or restraint such as is shown inFIG.6Fand in other embodiments disclosed herein and external blockers to movement such as those shown inFIGS.6O,6P, and/or6R can all be used to restrain movement in order to maintain a hinge effect that allows compression of the screws during final locking as well as reduction and counter-torque using an all in one system show in400. In contrast to prior art in which towers and extensions are designed to be parallel and do not interact, the constraint for movement during compression comes from external tools. In the present invention, because towers and blades crisscross and intermingle and interact directly, the extensions themselves create the hinge effect by direct limiting and constraining movement of one extension relative to another. This reduces the need for additional tools and saves time and space during surgery.

In some embodiments, the first extension410and the second extension420can be configured such that, in an operable state wherein the second extension420is advanced through the opening432in the first extension410, a contact between an outside surface of the second wall428of the second extension420and the first wall414of the first extension410surrounding the opening432will result in a hinge that the second extension420can rotate about relative to the first extension410. Further, the first extension410can be configured such that, in an operable state, when the second extension420is advanced through the opening432in the first extension410, the first wall414of the first extension410surrounding the opening432can be configured to prevent or inhibit the second extension420from rotating relative to the first extension410beyond a predetermined amount.

Further, in some embodiments, the first extension410can be configured such that, in an operable state, when the second extension420is advanced through the opening432in the first extension410and rotated so as to be in contact with the first wall414of the first extension410adjacent to the opening432, the first wall414of the first extension410surrounding the opening432can restrain a rotation of the second extension420relative to the first extension410so that moving a proximal end of the first extension410either toward or away from a proximal end of the second extension420will cause the distal end of the second extension420to move toward or away from the distal end410aof the first extension410, respectively. As with other embodiments, a proximal portion410bof the first extension410can be configured to be grasped by a surgeon to enable a surgeon to exert a rotational force on the first extension410about at least the axial centerline C of the distal portion410cof the first extension410and/or a torque force on the first extension410so as to cause the first extension410to rotate about an axis that is perpendicular to an axial centerline C of the distal portion410cof the first extension410.

Some embodiments of the second extension420can have any of the same features or details of any embodiments of the first extension410disclosed herein, including without limitation any of the details related to the opening, the cutouts, and/or the slots formed in the first extension410. In some embodiments, the second extension420can include an opening460(also referred to as a second opening) extending through the second wall428of the second extension420, wherein the opening460and the second extension420adjacent to the opening460can be sized and configured such that a third extension464can be advanced through the opening460in the second extension420in an operable state so that the third extension464is angled at an acute angle relative to an axial centerline C of the second extension420. In any embodiments disclosed herein, the third extension464can be a standard, straight, tubular extension configured to facilitate an implantation of a third screw466into a third vertebra.

In some embodiments, the first extension410and the second extension420can be configured such that the third extension464can be advanced through the opening432in in the first extension410and through the opening460in the second extension420in an operable state so that the third extension464is angled at an acute angle relative to the axial centerline C of the first extension410and the axial centerline C of the second extension420. In some embodiments, as in the illustrated embodiment, the third extension464can be configured to implant a screw generally perpendicularly into the third vertebra. In some embodiments, a distal end464aof the third extension464can be positioned between the distal end410aof first extension410and a distal end420aof the second extension420in an operable state.

In any embodiments disclosed herein, the second extension420can include at least one slot or window470extending through a first side472of the second extension420, the at least one slot470of the second extension420configured to receive a connecting element474(also referred to herein as a rod or connector) that is configured to extend between the first screw402and the second screw404in an operable state and/or to permit the connecting element474to pass therethrough. Further, in any embodiments disclosed herein, the second extension420can include a second slot476extending through a second side478of the second extension420(opposite to the first side472of the second extension), the second slot476also being configured to permit a connecting element474that is configured to extend between the first screw402and the second screw404in an operable state to pass through the second slot476.

Any embodiments of the system400disclosed herein can further include a rigid connecting element474, a first receiving element coupled with the screw head of the first screw402, and a second receiving element coupled with the screw head of the second screw404, wherein the first and second receiving elements can be configured to operably receive the connecting element474that, in an operable state, can extend between the first and second receiving elements when the first screw402and the second screw404are implanted in a first and a second vertebra405, respectively. In some embodiments, the first extension410can include a first slot480extending through the first wall thereof, the first slot480of the first extension410configured to permit a connecting element474configured to extend between the first screw402and the second screw404in an operable state to be advanced through the first slot480. With reference toFIG.4C, the first extension410can also have a second slot481configured to receive a connecting element474that is configured to extend between the first screw402and the second screw404in an operable state and/or to permit the connecting element474to pass therethrough.

In some embodiments, the first slot480of the first extension410can extend in a proximal direction from the distal end410aof the first extension410to the second cutout440of the first extension410. The first slot480of the first extension410can have a width that is less than 50% of a width of an outside surface of the first extension410.

As mentioned, the second extension420can include a first slot470extending through the second wall428of the second extension420, the first slot470of the second extension420configured to permit a connecting element474configured to extend between the first screw402and the second screw404in an operable state to be advanced through the first slot470of the second extension420. In some embodiments, the first slot470of the second extension420can extend in a proximal direction from the distal end420aof the second extension420to the second cutout440of the second extension420. Further, the first slot470of the second extension420can have a width that is less than 50% of a width of an outside surface of the second extension420.

In some embodiments, the first slot470of the second extension420can be in a first side472of the second wall428of the second extension420, and the second extension420can further include a second slot476extending through a second side478of the second wall428of the second extension420, the second side478of the second wall428being opposite to the first side472of the second wall428. The second slot476of the second extension420can be configured to permit a connecting element474configured to extend between the first screw402and the second screw404in an operable state to be advanced through the second slot476of the second extension420. In some embodiments, the second slot of the second extension420can extend in a proximal direction from the distal end of the second extension420and can have a length that is 40% (or approximately 40%) or greater of a length of the second extension420, or that is 30% (or approximately 30%) or greater of the length of the second extension420.

Some embodiments of methods for treating a spinal defect include implanting the first screw402that can be coupled with the first extension410through the incision into a first vertebra403(as shown inFIGS.4H-4I). Note that, in some embodiments, a tool removably coupled with any of the screws disclosed herein can be advanced through any of the guiding elements or extensions and removably engage with the screw head of the screw to implant the screw. Further, with reference toFIGS.4J-4K, the second extension420that can be coupled with the second screw404can be advanced through the incision and through the opening432formed in the first extension410so that the axial centerline C of the second extension420can be at an acute angle A relative to the axial centerline C of the first extension410and so that the second screw404can be implanted into a second vertebra405. Further, as described above, with reference toFIGS.4L-4M, if a two level fusion is desired, the third extension464can be advanced through the opening432in the first extension and the opening460in the second extension420so that the third screw466can be implanted in the third vertebra467. With reference toFIG.4L-4M, a third screw466can be implanted into a third vertebra467that is between the first and second vertebra403,405by advancing the third extension464through the first and second cutouts434,440of the first extension410and through the first and second cutouts434,440of the second extension410. If only a two level fusion is desired, the first extension410and the second extension420can be coupled with screws that are positioned in adjacent vertebra or, in other embodiments, are not positioned in adjacent vertebra.

In any embodiments disclosed herein, the screw can be implanted using other means, and the extensions or guide elements can be coupled with the screw heads or other components coupled with the screws after the screws have been implanted. In any embodiments disclosed herein, the extensions, guide elements, and/or towers can be used with any of the devices or components shown and described in relation toFIGS.1A-1Z, including without limitation the wires140a,140b, the screws110, the inserts116a, and/or the screw heads114. For example and without limitation, in any embodiments, the first and second extensions410,420can be passed over any of the wires140a,140band secured to the screws110or screw heads114so that the first and second extensions410,420are coupled with the screws110for further procedures as disclosed herein or otherwise.

The third extension464in some embodiments can be supported within the opening432of the first extension410and the opening460of the second extension420so that the third extension464is restricted to a position in which the third extension464is at an acute angle relative to an axial centerline C of the second extension420and/or the first extension410. The method or procedure can also include moving a proximal portion410bof the first extension410toward a proximal portion of the second extension420to cause an outside surface of the second extension420to hinge relative to the second extension420, for example and without limitation, by contacting at least a distal edge446of the opening432in the first extension410or other contact surface of the first extension410. In this arrangement, further movement of the proximal portion410bof the first extension410toward the proximal portion of the second extension420can cause a rotation of the second extension420about the hinge point which, again, can be the distal edge446of the opening432or other contact surface of the first extension410, to move the distal end portion of the first extension410toward the distal end portion of the second extension420. This method or procedure can be used to move the first vertebra403that the first screw402is implanted into toward the second vertebra405that the second screw404is implanted into, and/or move the first vertebra403that the first screw402is implanted into and the second vertebra405that the second screw404is implanted into toward the third vertebra467that the third screw466is implanted into.

With reference toFIGS.4N-4T, to secure the first and second vertebra405in the desired positions, the surgeon can couple a rigid connecting element474with the first screw402, the second screw404, and/or the third screw466to generally fix a position of the first screw402relative to the second screw404and/or the third screw466. A connecting element insertion device484can be used to advance the connecting element464through the openings, channels, and/or slots of the first extension410, the second extension420, and/or the third extension466and into the channels or tulips coupled with the first screw402, second screw404, and/or the third screw466. A second connecting element insertion device485can also be used with the connecting element insertion device484to advance the connecting element464through the openings, channels, and/or slots of the first extension410, the second extension420, and/or the third extension466and into the channels or tulips coupled with the first screw402, second screw404, and/or the third screw466.

For example and without limitation, the second connecting element insertion device485can push the connecting element464out from the connecting element insertion device484and hold the connecting element464in a desired position when the connecting element insertion device484is removed. The second connecting element insertion device485can then allow for a cap to be placed through the third extension464to lock and also reduce the connecting element464down to the third screw. At this point, in some embodiments, the third screw466can be final tightened (i.e., to the final torque tightness).

In some embodiments, the second connecting element insertion device485can have variable length blades so that both blades can contact the connecting element464on either side of the third tower464even when the connecting element464is more vertical in orientation. The variable blade lengths of some embodiments of the second connecting element insertion device485can then be used to push the connecting element464down until the connecting element464is horizontal and sitting in the seat or receiving element of all three of the first, second, and third screws. Once the connecting element464is down into the seat of the screws, the second connecting element insertion device485can be used to hold the connecting element464down as the connecting element insertion device484is removed, allowing a cap to be placed into the third tower to secure the connecting element464in place and even reducing the connecting element464into the third tower if there is spondylolisthesis.

It is again important to note that, in any embodiments, the first, second, and third extensions410,420,464coupled with the screws extend outside the body through the incision, and the proximal ends thereof can provide “handles” to allow the surgeon to know the position and orientation of the three screw heads constantly. This arrangement can also permit a robotic system to “know” the orientation and position of all screw heads so that a robotic system would be able to lower the connecting element464directly into the screw heads, including with rotating the connecting element464from vertical to horizontal into the seat of the heads of the screws. Any of the extensions can have additional components added thereto or otherwise be configured to integration into a robotic system. Thereafter, the extensions can be removed and withdrawn from the body.

Additionally, stereotactic intraoperative navigation and robotic assistance have been implemented in spinal fusion surgery. Both navigation and robotic guidance have been used to guide the trajectories of pedicle screws either using guidewires or direct placement of screws into the vertebrate. However, thus far, stereotactic navigation nor robotics have been used to assist in lining up the screw heads or assisted in the placement of the rod or connecting element into the seat of the screw heads. Lastly, with the natural lordotic curve of the lumbar spine, especially at L4, L5, and S1 (where 80% of all fusions occur), the traditional towers or extensions connected to the pedicle screws typically cross paths and interfere with each other during minimally invasive screw placement. Typically, the towers end up crossing at the incision but next to one another. In the embodiments disclosed herein, the towers are designed to criss-cross within each other. Thus there is no interference to the crossed trajectories of the screw extension elements and towers. Furthermore, by having attachments to the proximal ends of the extensions by which robotic arms can attach and thus “know” the 3-dimensional special orientation of each tower or extension relative to each other.

By computer modeling and “knowing” the 3-D spatial composition of each part, a robotic system is able to implant screw402with extension410and then implant screw404with extension440. The robotic system is able to adjust the two extensions and thereby the screws attached to them to align the screw heads. The robotic system is then able to insert a third screw for a two level fusion. Because the screw heads are aligned and the channel is created between the towers by the cutouts and openings, there is a natural space for the rod or extension element to be inserted by another robotic arm. In this manner, then entire process from pedicle screw trajectory localization to screw insertion to alignment of the screw heads to insertion of the rod and then insertion of the locking caps. The final locking step with compression of the towers can also be performed by the same robotic arms by squeezing the proximal ends of the extension towers together and final locking the connecting element or rod using the locking caps. The entire process can be performed by a streamlined process without fear of interference of the paths of the different screws due to the lumbar lordosis.

Certain aspects of the systems, devices, components and/or methods described above or as illustrated with respect toFIGS.4A-4Tare also encompassed by the following numbered embodiments. These numbered embodiments are considered to be directed to systems, devices, components and/or methods that include but are not limited to the embodiments ofFIGS.4A-4T, and thus these numbered embodiments may encompass other embodiments as described throughout this specification.1. A system for stabilizing spinal vertebrae through a skin incision, comprising:a first screw having a first screw head;a second screw having a second screw head;a first extension configured to be removably coupled with the first screw at a distal end of the first extension, the first extension having a wall and a first passageway extending through the first extension along an axial centerline of the first extension such that the wall of the first extension at least partially surrounds the first passageway; anda second extension configured to be removably coupled with the second screw at a distal end of the second extension, the second extension having a wall and a second passageway extending through the second extension along an axial centerline of the second extension such that the wall of the second extension at least partially surrounds the second passageway; anda first opening extending through the wall of the first extension;wherein:the first opening and the wall of the first extension adjacent to the first opening are sized and configured such that the second extension can be advanced through the first opening so that the second extension is restrained within the first opening and positionable at an acute angle relative to an axial centerline of the first extension.2. The system of Embodiment 1, wherein the first extension is removably coupleable with the first screw such that, when the first extension is coupled with the first screw, the axial centerline of the first extension is approximately collinear with an axial centerline of the first screw and wherein the second extension is removably coupleable with the second screw such that, when the second extension is coupled with the second screw, an axial centerline of the second extension is approximately collinear with an axial centerline of the second screw.3. The system of Embodiment 1 or 2, wherein the first extension and the second extension are generally cylindrically shaped.4. The system of any one of the previous Embodiments, wherein the first extension and the second extension are generally rigid.5. The system of any one of the previous Embodiments, wherein the first extension and the second extensions have a tubular shape.6. The system of any one of the previous Embodiments, wherein at least a distal portion of the first extension has an adjustable length.7. The system of any one of the previous Embodiments, wherein the first screw is configured to be implanted in a first vertebra and the second screw is configured to be implanted into a second vertebra.8. The system of any one of the previous Embodiments, wherein the first extension is sized and configured such that, in an operable state, a proximal portion of the first extension extends away from a skin incision toward a surgeon.9. The system of any one of the previous Embodiments, wherein an inside size of the wall of the first extension adjacent to the first opening in the first extension is greater than an outside size of at least a portion of the wall of the second extension such that at least a portion of the second extension can be passed through the first opening of the first extension at an acute angle relative to the axial centerline of the first extension and be at least partially surrounded by the wall of the first extension.10. The system of any one of the previous Embodiments, wherein:a proximal portion of the first extension has an inside cross-sectional size that is greater than an inside cross-sectional size of a distal portion of the first extension; andthe inside cross-sectional size of the proximal portion of the first extension is also greater than an outside cross-sectional size of at least a distal portion of the second extension so that at least the distal portion of the second extension can be advanced completely through the first opening of the first extension.11. The system of any one of the previous Embodiments, wherein the first opening in the first extension passes through the wall of the first extension at an angle that is acute to the axial centerline of the first extension.12. The system of any one of the previous Embodiments, wherein the first opening comprises a first cutout in a first side of the wall and a second cutout in a second side of the wall of the first extension, wherein: the second side of the wall is opposite to the first side of the wall; the second cutout is separate from the first cutout such that the first and second cutouts are not overlapping or connected; and the second cutout is positioned closer to a distal end of the first extension than the first cutout.13. The system of Embodiment 12, wherein the first cutout extends in a distal direction from a 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 passageway at the proximal end of the first extension.14. The system of Embodiment 12 or 13, wherein the first cutout removes at least approximately 40% of the wall of the first extension at least the proximal end of the first extension.15. The system of any one of Embodiments 12-14, wherein the first cutout extends along a length of the first extension that is at least approximately 30% of a total length of the first extension.16. The system of any one of Embodiments 12-15, wherein the first cutout extends along a length of the first extension that is at least approximately 40% of a total length of the first extension.17. The system of any one of Embodiments 12-16, wherein a distal edge of the first cutout is planar and is angled downwardly toward the distal end of the first extension.18. The system of any one of Embodiments 12-17, wherein a proximal portion of the second cutout overlaps a distal portion of the first cutout in an axial direction.19. The system of any one of Embodiments 12-18, wherein the second cutout is positioned between a proximal end and the distal end of the first extension such that a proximal end of the second cutout is spaced apart from the proximal end of the first extension and a distal end of the second cutout is spaced apart from the distal end of the first extension.20. The system of any one of Embodiments 12-19, wherein the second cutout removes at least approximately 40% of the wall of the first extension in at least a middle portion of the first extension.21. The system of any one of Embodiments 12-20, wherein the second cutout extends along a length of the first extension that is at least approximately 30% of a total length of the first extension.22. The system of any one of Embodiments 12-21, wherein the second cutout extends along a length of the first extension that is at least approximately 40% of a total length of the first extension.23. The system of any one of Embodiments 12-22, wherein a proximal edge of the second cutout is curved.24. The system of any one of Embodiments 12-23, wherein a distal edge of the second cutout is planar and is angled downwardly toward the distal end of the first extension.25. The system of any one of the previous Embodiments, wherein the first extension and the second extension are configured such that, in an operable state wherein the second extension is advanced through the first opening in the first extension, moving a proximal end of the first extension either toward or away from a proximal end of the second extension will cause the second extension to hinge about an edge of the first opening and rotate relative to first extension about the edge of the first opening in the first extension so as to cause the distal end of the second extension to move toward or away from the distal end of the first extension, respectively.26. The system of any one of the previous Embodiments, wherein the first extension and the second extension are configured such that, in an operable state wherein the second extension is advanced through the first opening in the first extension, a contact between an outside surface of the wall of the second extension and the wall of the first extension surrounding the first opening will result in a hinge that the second extension can rotate about relative to the first extension.27. The system of any one of the previous Embodiments, wherein the first extension is configured such that, in an operable state, when the second extension is advanced through the first opening in the first extension, the wall of the first extension surrounding the first opening prevents the second extension from rotating relative to the first extension beyond a predetermined amount.28. The system of any one of the previous Embodiments, wherein the first extension is configured such that, in an operable state, when the second extension is advanced through the first opening in the first extension and rotated so as to be in contact with the wall of the first extension adjacent to the first opening, the wall of the first extension surrounding the first opening restrains a rotation of the second extension relative to the first extension so that moving a proximal end of the first extension either toward or away from a proximal end of the second extension will cause the distal end of the second extension to move toward or away from the distal end of the first extension, respectively.29. The system of any one of the previous Embodiments, wherein a proximal portion of the first extension is configured to be grasped by a surgeon to enable a surgeon to exert a rotational force on the first extension about at least the axial centerline of the distal portion of the first extension and/or a torque force on the first extension so as to cause the first extension to rotate about an axis that is perpendicular to an axial centerline of the distal portion of the first extension.30. The system of any one of the previous Embodiments, wherein the second extension comprises a second opening extending through the wall of the second extension, and wherein the second opening and the second extension adjacent to the second opening are sized and configured such that a third extension can be advanced through the second opening in an operable state so that the third extension is angled at an acute angle relative to an axial centerline of the second extension.31. The system of Embodiment 30, wherein the first extension and the second extension are configured such that the third extension can be advanced through the first opening in in the first extension and through the second opening in the second extension in an operable state so that the third extension is angled at an acute angle relative to the axial centerline of the first extension and the axial centerline of the second extension.32. The system of Embodiment 30 or 31, wherein a distal end of the third extension is positioned between the distal end of first extension and a distal end of the second extension in an operable state.33. The system of any one of Embodiments 30-32, wherein the third extension has a tubular shape.34. The system of any one of the previous Embodiments, wherein the second extension comprises at least one slot extending through the wall of the second extension, the at least one slot of the second extension being configured to receive a connecting element that is configured to extend between the first and second screws in an operable state.35. The system of any one of the previous Embodiments, further comprising:a rigid connecting element;a first receiving element coupled with the first screw head; anda second receiving element coupled with the second screw head;wherein the first and second receiving elements are configured to operably receive the connecting element that, in an operable state, extends between the first and second receiving elements when the first and second screws are implanted in a first and a second vertebra, respectively.36. The system of any one of the previous Embodiments, wherein the first extension comprises a first slot extending through the wall thereof, the first slot of the first extension configured to permit 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.37. The system of Embodiment 36, wherein the first slot of the first extension extends in a proximal direction from the distal end of the first extension to the second cutout of the first extension.38. The system of Embodiment 36, wherein the first slot of the first extension has a width that is less than 50% of a width of an outside surface of the first extension.39. The system of any one of the previous Embodiments, wherein the second extension comprises a first slot extending through the wall of the second extension, the first slot of the second extension configured to permit 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.40. The system of Embodiment 39, wherein the first slot of the second extension extends in a proximal direction from the distal end of the second extension to the second cutout of the second extension.41. The system of Embodiment 39, wherein the first slot of the second extension has a width that is less than 50% of a width of an outside surface of the second extension.42. The system of Embodiment 39, wherein the first slot of the second extension is in a first side of the wall of the second extension, and wherein the second extension further comprises a second slot extending through a second side of the wall of the second extension, the second side of the wall of the second extension being opposite to the first side of the wall of the second extension, the second slot of the second extension configured to permit a connecting element configured to extend between the first screw and the second screw in an operable state to be advanced through the second slot of the second extension.43. The system of Embodiment 42, wherein the second slot of the second extension extends in a proximal direction from the distal end of the second extension and has a length that is approximately 40% or greater of a length of the second extension.44. A method of stabilizing spinal vertebrae comprising:implanting a first screw that is coupled with a first extension through an incision into a first vertebra;advancing a second extension that is coupled with a second screw through the incision and through a first opening formed in the first extension so that an axial centerline of the second extension is at an acute angle relative to an axial centerline of the first extension;implanting the second screw into a second vertebra;moving a proximal portion of the first extension toward a proximal portion of the second extension to cause an outside surface of the second extension to contact at least a distal edge of the first opening in the first extension; andfurther moving the proximal portion of the first extension toward the proximal portion of the second extension to rotate the second extension about at least the distal edge of the first opening to move 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.45. The method of Embodiment 44, further comprising coupling a rigid connector with the first screw and the second screw to generally fix a position of the first screw relative to the second screw.46. A system for bone stabilization, comprising:a first screw comprising a first screw head; anda first guiding element configured to extend away from the first screw, wherein the first guiding element comprises: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 the first screw head; andan opening extending through an intermediate section of the partially enclosed tubular body, the opening oriented at an angle to the first longitudinal axis.47. The system of Embodiment 46, wherein the partially enclosed tubular body comprises:a proximal portion proximal to the intermediate section comprising a partially enclosed tubular section having an inner concave surface facing in a first direction and an outer convex surface facing in a second direction opposite to the first direction;a distal portion distal to the intermediate section comprising a partially enclosed tubular section having an inner concave surface facing in the second direction and an outer convex surface facing in the first direction.48. The system of Embodiment 47, wherein the proximal portion circumscribes a surface of at least 180°.49. The system of Embodiment 47 or 48, wherein the distal portion circumscribes a surface of at least 180°.50. The system of any one of Embodiments 47-49, wherein the distal portion comprises a longitudinal slot extending to the distal end of the partially enclosed tubular body.51. The system of any one of Embodiments 47-50, further comprisinga second screw comprising a second screw head; anda second guiding element configured to extend away from the second screw;wherein the second guiding element is configured to pass through the opening of the first guiding element.52. The system of Embodiment 51, wherein the second guiding element comprises: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 the second screw head, andan opening extending through an intermediate section of the partially enclosed tubular body, the opening extending at an angle to the second longitudinal axis.53. The system of Embodiment 52, wherein the partially enclosed tubular body of the second guiding element comprises:a proximal portion proximal to the intermediate section comprising a partially enclosed tubular section having an inner concave surface facing in a third direction and an outer convex surface facing in a fourth direction opposite to the third direction; anda distal portion distal to the intermediate section comprising a partially enclosed tubular section having an inner concave surface facing in the fourth direction and an outer convex surface facing in the third direction.54. The system of Embodiment 53, further comprisinga third screw comprising a third screw head; anda third guiding element configured to extend away from the third screw;wherein the third guiding element is configured to pass through the openings of the first guiding element and the second guiding element.55. The system of Embodiment 54, wherein the third guiding element comprises a tubular body.56. The system of Embodiment 55, wherein the third guiding element comprises a longitudinal slot to facilitate passage of a rod.57. The system of any one of Embodiments 46-56, further comprising a rod inserter configured to deliver a rod.58. The system of Embodiment 57, further comprising a rod trapper configured to release the rod from the rod inserter.59. A system for bone stabilization, comprising:a plurality of guiding elements, wherein each of the plurality of guiding elements comprises: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; andan opening extending through an intermediate section of the partially enclosed tubular body, the opening oriented at an angle to a longitudinal axis of the guiding element;wherein the opening of each of the plurality of guiding elements is sized and configured to allow for passage of another guiding element therethrough.60. The system of Embodiment 59, wherein the plurality of guiding elements comprises a first guiding element and a second guiding element each comprising:a proximal portion proximal to the intermediate section comprising a partially enclosed tubular section having an inner concave surface facing in a first direction and an outer convex surface facing in a second direction opposite to the first direction; anda distal portion distal to the intermediate section comprising a partially enclosed tubular section having an inner concave surface facing in the second direction and an outer convex surface facing in the first direction;wherein the second guiding element is configured to pass through the opening in the first guiding element, and wherein the inner concave surfaces of the proximal portions of the first and second guiding elements face each when the second guiding element passes through the opening in the first guiding element.61. The system of Embodiment 59 or 60, wherein the plurality of guiding elements comprises a first guiding element, a second guiding element, and a third guiding element, wherein the opening extending through the intermediate section of the first guiding element is sized and configured to allow for passage of the second guiding element therethrough, and wherein the opening extending through the intermediate section of the third guiding element is sized and configured to allow for passage of the first and the second guiding elements therethrough when the second guiding element is passed through the opening of the first guiding element.
Systems, Devices and Methods ofFIGS.5A-5K

Described below are embodiments directed to a system500for stabilizing spinal vertebrae through a skin incision S. In any embodiments disclosed herein, any components, features, or other details of the system500can have any of the components, features, or other details of any other system embodiments disclosed herein or be used according to any of the steps of any other method embodiments disclosed herein, including without limitation any of the embodiments of the system200,300, and/or400or methods of use thereof described above, in any combination with any of the components, features, or details of the system500or methods of use disclosed below. Similarly, any components, features, steps, or other details of any of the other system or method embodiments disclosed herein can have any of the components, features, steps, or other details of any embodiments of the system500or methods of use thereof disclosed herein in any combination with any of the components, features, or details of the system.

In any embodiments disclosed herein, the system500can have blades that have openings that can be positioned at various lengths relative to the screw head, for example. The openings can be sized and configured to allow other screws and towers or other guiding elements or extensions to pass through the openings.

In any embodiments disclosed herein, the blades can then be attached to or coupled with the screw by any appropriate attachment mechanisms. In some embodiments, one or more wires including, without limitation, wires140a,140b, can be used to couple the blades with the screw heads. Then, when the desired number of towers are engaged with the screw heads, in any embodiments disclosed herein, one or more connectors or caps can couple each pair of blades together to close the towers and also increase the rigidity of the blades and towers. Additionally, in any embodiments disclosed herein, the blades can have one or more stiffeners or reinforcements proximal to or distal to the openings to increase the bending stiffness of the blades or the proximal and distal portions of the blades can have an increased stiffness to reduce the flexibility of the towers during use.

In some embodiments, the system500can include a first screw502that can include a first screw head504, the first screw head504including a first side506and a second side508, the first side506and the second side508being opposite each other, and a first guiding element510configured to extend away from the first screw502. In any embodiments disclosed herein, the first guiding element510can include a first blade520extending along a first longitudinal axis A1between a proximal end520aand a distal end520aof the first blade520. The first blade520can include a curved intermediate section524between the proximal and distal ends520a,520b. The distal end520bof the first blade520can be configured to engage with or couple with the first side506of the first screw head504.

The first guiding element510can further include a second blade530extending along a second longitudinal axis A2between a proximal end530aand a distal end530b. The second blade530can include a curved intermediate section534between the proximal and distal ends530a,530b. The distal end530bof the second blade530can be configured to engage with the second side508of the first screw head504. The first guiding element510can be configured such that, when the distal end520bof the first blade520and the distal end530bof the second blade530are engaged with the first screw head504, an inner surface520cof the first blade520faces an inner surface530cof the second blade530and is spaced therefrom. Further, in some embodiments, the curved intermediate sections524,534of the first and second blades520,530can form an enlarged opening540with an increased spacing between the inner surfaces520c,530cof the first and second blades520,530relative to a spacing between the inner surfaces of the first blade520and the second blade530proximal and distal to the intermediate sections524,534.

In any embodiments, the first and second longitudinal axes A1, A2can be parallel to one another when the distal ends520b,530bof the first blade520and the second blade530are engaged with the first screw head504. Further, in some embodiments, the curved intermediate sections of each of the first blade520and the second blade530can be bowed outwardly and can have a curved or rounded shape. In any other embodiments, the intermediate sections of each of the first blade520and the second blade530can be bend bowed outwardly to a midpoint of the intermediate sections and can have an angled or a tapered shape. The first blade520and the second blade530can bend inwardly proximal to the midpoint of the intermediate sections.

In some embodiments, the enlarged opening540of the first guiding element510can be oriented parallel or substantially parallel to the inner surfaces of the first and second blades520,530. Further, in any embodiments disclosed herein, each of the first blade520and the second blade530, and/or any blade of any guiding element disclosed herein, can have a substantially uniform cross-sectional thickness from the proximal end to the distal end.

In some embodiments, the enlarged opening540of the first guiding element510can be configured to allow passage of a subsequently advanced guiding element or a plurality of subsequently advanced guiding elements therethrough, including without limitation an enlarged intermediate portion of a subsequently advanced guiding element or subsequently advanced guiding elements. For example and without limitation, in some embodiments, the enlarged opening540between the first blade520and the second blade530can be sized and configured to allow for passage of the second screw and the second guiding element510therethrough, including the enlarged intermediate section of the second guiding element.

With reference toFIG.5B, some embodiments of the guiding element510can be configured such that the first blade520has a proximal section540and a distal section542and the second blade530has a proximal section544and a distal section546, wherein the intermediate section524of the first blade520is between the proximal and distal sections540,542of the first blade520, and wherein the intermediate section534of the second blade530is between the proximal and distal sections540,542of the second blade530. In any embodiments disclosed herein, the proximal sections540,544of the first and second blades520,530and/or the distal sections542,546of the first and second blades520,530can be planar or substantially planar and parallel to each other.

In some embodiments, a distance of the increased spacing (e.g., at the enlarged opening540) between the inner surfaces of the third and fourth blades560,564of a second guiding element550can be less than a distance of the increased spacing (e.g., the enlarged opening540) between the inner surfaces of the first blade520and the second blade530. For example and without limitation, in any embodiments disclosed herein, a width WO of the guiding element from the inside surface of the first blade to the inside surface of the second blade at the widest point of the opening (as shown inFIG.5B) can be approximately 100% greater than (i.e., twice as wide as) a width WP from the inside surface of the first blade to the inside surface of the second blade in the proximal portion (e.g., proximal portion540,544of the first and second blades520,530), or from 80% (or approximately 80%) greater to 400% (or approximately 400%) or more greater than the width WP from the inside surface of the first blade to the inside surface of the second blade in the proximal portion. In any embodiments disclosed herein, the proximal portion and the distal portion of the guiding elements can have approximately the same width, or can have a different width.

In any embodiments disclosed herein, the guiding elements can have any of a range of lengths suitable for a range of differently sized anatomies, thereby permitting a surgeon to choose the desired length or lengths of the blades and positions of the enlarged openings after measurement of the depth of the tissue, for example. With reference toFIG.5D, the guiding elements510can be provided in varying lengths where the length of the distal portion LD to the distal edge of the enlarged opening540can vary. For example and without limitation, kits can be provided wherein the system has a range of guiding elements510having a range of overall lengths and a range of lengths LD of the distal portion of the guiding element. As shown inFIG.5D, some embodiments of the guiding element510can have a distal portion having a length LD1that is less than a second guiding element510that has a distal portion having a length LD2. LD2can also be less than that of a third guiding element510that has a distal portion having a length LD3, which can be less than a fourth guiding element510that has a distal portion having a length LD4. LD4can be less than that of a fifth guiding element510that has a distal portion having a length LD5. In any embodiments, the overall length and/or the length of the distal portion LD can be 10% (or approximately 10% or less) greater between each of the successive sizes, or 15% (or approximately 15%) greater between each of the successive sizes, or 20% (or approximately 20% more) greater between each of the successive sizes.

For example and without limitation, the enlarged opening of any of the embodiments of the guiding elements disclosed herein can be oriented at any desired angle (for example, a perpendicular angle, or any acute or non-perpendicular angle) relative to a longitudinal axis of the guiding element so that the enlarged opening in the guiding element can be at any desired angle when the distal ends of the first blade and the second blade are engaged with the first screw head.

In some embodiments, with reference toFIGS.5E-5G, the enlarged opening540of the first guiding element510can be oriented at an angle relative to an axial centerline axis C (also referred to as a longitudinal axis), for example and without limitation, when the distal ends of the first blade520and the second blade530are engaged with the first screw head504. For example, as shown inFIG.5E, the first opening540of the first guiding element510(or any other guiding element, including the second guiding element, third guiding element, etc.) can be at an angle A1relative to the centerline axis C that can be 90° (or approximately 90°). As shown inFIG.5F, the first opening540of the first guiding element510(or any other guiding element, including the second guiding element, third guiding element, etc.) can be at an angle A2relative to the centerline axis C that can be less than 90, such as, for example, 70° (or approximately 70°) relative to the centerline axis C, or from 50° (or approximately 50°) to 75° (or approximately 75°) relative to the centerline axis C. As shown inFIG.5G, the first opening540of the first guiding element510(or any other guiding element, including the second guiding element, third guiding element, etc.) can be at an angle A3relative to the centerline axis C that can be less than A2, such as, for example, 45° (or approximately 45°) relative to the centerline axis C, or from 30° (or approximately 30°) to 50° (or approximately 50°) relative to the centerline axis C.

In this arrangement, with reference toFIG.5H, the first guiding element510can have an enlarged opening540at an angle A relative to the centerline axis C of the first guiding element510that can permit the second guiding element550to pass therethrough so that the second guiding element550, in an operable state as shown inFIG.5H, can be oriented so that a centerline axis C of the second guiding element550is also angled at the same angle A relative to the centerline axis as the enlarged opening540of the first guiding element. Again, the angle A of the first guiding element can be any desired angle. In any embodiments, the angle of the enlarged opening can be an acute or non-perpendicular angle, such as angle A2or angle A3shown inFIGS.5E,5F. The angle can range from 20° (or approximately 20°) or less to 70 (or approximately 70°) or more, or from 40° (or approximately 40°) to 60 (or approximately 60°), within a kit. In any embodiments disclosed herein, the second guiding element550or a third guiding element582can have generally planar blades as shown, or can also have an enlarged opening configured to permit the passage of a third guiding element therethrough.

In any embodiments disclosed herein, as shown inFIG.5C, the system500can further include a second guiding element550that can have any of the same features, components, and/or other details of any of the embodiments of the first guiding element510disclosed herein, including an enlarged opening at any desired angle. The second guiding element550can include a second screw552that can include a second screw head554having a first side556and a second side558wherein the first side556and the second side558are opposite each other. The second guiding element550can be configured to extend away from the second screw552and can include a third blade560extending along a third longitudinal axis between a proximal end560aand a distal end560b, wherein the distal end560bof the third blade560is configured to engage with the first side556of the second screw head554. The second guiding element510can also include a fourth blade564extending along a fourth longitudinal axis A4between a proximal end564aand a distal end564b, wherein the distal end564bof the fourth blade564is configured to engage with the second side558of the second screw head554.

Similar to the first blade520, the third blade560can include a curved intermediate section566between the proximal and distal ends560a,560band the fourth blade564can include a curved intermediate section568between the proximal and distal ends564a,564b. Further, in some embodiments, the curved intermediate sections566,568of the third and fourth blades560,564can form an enlarged opening570with an increased spacing between the inner surfaces560c,564cof the third and fourth blades560,564relative to a spacing between the inner surfaces of the first blade560and the second blade564proximal and distal to the intermediate sections566,568.

In some embodiments, the distal ends560b,564bof the third and fourth blades can be engaged with the second screw head554. Further, an inner surface560cof the third blade560can face an inner surface564cof the fourth blade564and can be spaced therefrom.

In some embodiments, with reference toFIGS.5C and5I-5K, the enlarged opening570of the second guiding element550can be configured to allow passage of a subsequently advanced guiding element or a plurality of subsequently advanced guiding elements therethrough, including without limitation an enlarged intermediate portion of a subsequently advanced guiding element or subsequently advanced guiding elements, or a subsequently advanced guiding element having generally straight or planar blades. For example and without limitation, in some embodiments, the enlarged opening570between the third blade560and the fourth blade564can be sized and configured to allow for passage of the third screw580and a third guiding element582therethrough, wherein the third guiding element582has generally planar blades, or guiding elements having enlarged intermediate sections.

In any embodiments, as shown inFIGS.5I-5K, a size and/or an orientation of the enlarged opening570between the third and fourth blades of the second guiding element550can be different than the orientation of the enlarged opening540between the first blade520and the second blade530of the first guiding element540. Further, in any embodiments disclosed herein, a longitudinal position of the enlarged opening of the second guiding element can be different than a longitudinal position of the enlarged opening of the second guiding element.

In some embodiments, the third guiding element can have an enlarged opening that is configured to permit the passage of a first guiding element and a second guiding element therethrough. In some embodiments, the third guiding element can have an enlarged opening having any of the features or details of any of the embodiments disclosed herein and the first guiding element can have an enlarged opening having any of the features or details of any of the embodiments disclosed herein. The second guiding element can have an enlarged opening therein or can have generally planar blades. In some embodiments, the enlarged opening of the third guiding element can be sized and configured to permit the passage of the first and the second guiding elements, and the first guiding element can be sized and configured to permit the passage of the second guiding element.

In some embodiments, the third guiding element can include a fifth blade extending along a fifth longitudinal axis between a proximal end and a distal end, the fifth blade including either a straight or a curved intermediate section between the proximal and distal ends, wherein the distal end of the fifth blade is configured to engage with a first side of a third screw head. In some embodiments, the third guiding element can have a sixth blade extending along a second longitudinal axis between a proximal end and a distal end, the sixth blade that can include a straight or a curved intermediate section between the proximal and distal ends, wherein the distal end of the sixth blade is configured to engage with a second side of the third screw head. An inner surface of the fifth blade can face an inner surface of the sixth blade and can be spaced therefrom, as shown in the figures. In some embodiments, the curved intermediate sections of the fifth and sixth blades can form an enlarged opening with an increased spacing between the inner surfaces of the fifth and sixth blades relative to a spacing between the inner surfaces of the fifth and sixth blades proximal and distal to the intermediate sections.

Further, in some embodiments, a distance of the increased spacing at the enlarged opening, if any, between the inner surfaces of the fifth and sixth blades can be greater than a distance of the increased spacing between the inner surfaces of the first blade520and the second blade530, such that the enlarged opening between the fifth and sixth blades can be sized and configured to allow for passage of the second screw and the second guiding element510therethrough and to allow for passage of the first screw502and the first guiding element510therethrough.

Some embodiments of the system500for bone stabilization can include a plurality of guiding elements, wherein each of the plurality of guiding elements can include a first blade520that can include a proximal end520aand a distal end520b, the first blade520including a curved intermediate section524between the proximal and distal ends520a,520b, and a second blade530that can include proximal end530aand a distal end530b, the second blade including a curved intermediate section534between the proximal and distal ends530a,530b. In some embodiments, the distal ends520b,530bof the first blade520and the second blade530can be configured to engage with a bone screw502such that, when engaged with the bone screw502an inner surface520cof the first blade520faces an inner surface530cof the second blade530and is spaced therefrom. Further, the curved intermediate sections524,534of the first blade520and the second blade530can form an enlarged opening540with an increased spacing between the inner surfaces520c,530cof the first blade520and the second blade530relative to a spacing between the inner surfaces520c,530cof the first blade520and the second blade530proximal and distal to the intermediate sections524,534. Further, in some embodiments, the first blade520and the second blade530of a first guiding element510of the plurality of guiding elements can form an enlarged opening540having a different longitudinal position, a different spacing between the inner surfaces of the first blade520and the second blade530, and/or a different orientation as compared to the enlarged opening formed by the first blade560and the second blade564of a second guiding element550of the plurality of guiding elements.

Further, in some embodiments, wherein the system500includes a third guiding element having an enlarged opening, a first blade and a second blade of the third guiding element of the plurality of guiding elements can form an enlarged opening having a different longitudinal position, a different spacing between the inner surfaces of the first and second blades, and/or a different orientation as compared to the enlarged opening formed by the first and second blades of the second of the plurality of guiding elements and as compared to the enlarged opening formed by the first and second blades of the first of the plurality of guiding elements. The third guiding element can be coupled with a screw head of a third screw.

Further, in some embodiments, wherein the system500includes a fourth guiding element having an enlarged opening, the first and second blades of the fourth guiding element of the plurality of guiding elements can form an enlarged opening having a different longitudinal position, a different spacing between the inner surfaces of the first and second blades, and/or a different orientation as compared to the enlarged opening formed by the first and second blades of the third of the plurality of guiding elements, as compared to the enlarged opening formed by the first and second blades of the second of the plurality of guiding elements, and as compared to the enlarged opening formed by the first and second blades of the first of the plurality of guiding elements. The fourth guiding element can be coupled with a screw head of a fourth screw.

Further, in some embodiments, wherein the system500includes a fifth guiding element having an enlarged opening, the first and second blades of the fifth guiding element can form an enlarged opening having a different longitudinal position, a different spacing between the inner surfaces of the first and second blades, and/or a different orientation as compared to the enlarged opening formed by the first and second blades of the fourth of the plurality of guiding elements, as compared to the enlarged opening formed by the first and second blades of the third of the plurality of guiding elements, as compared to the enlarged opening formed by the first and second blades of the second of the plurality of guiding elements, and as compared to the enlarged opening formed by the first and second blades of the first of the plurality of guiding elements. The fifth guiding element can be coupled with a screw head of a fifth screw.

Certain aspects of the systems, devices, components and/or methods described above or as illustrated with respect toFIGS.5A-5Kare also encompassed by the following numbered embodiments. These numbered embodiments are considered to be directed to systems, devices, components and/or methods that include but are not limited to the embodiments ofFIGS.5A-5K, and thus these numbered embodiments may encompass other embodiments as described throughout this specification.1. A system for bone stabilization, comprising:a first screw comprising a first screw head, the first screw head comprising a first side and a second side, the first side and the second side being opposite each other; anda first guiding element configured to extend away from the first screw, wherein the first guiding element comprises: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 and distal ends, wherein the distal end of the first blade is configured to engage with the first side of the first screw head, anda second blade extending along a second longitudinal axis between a proximal end and a distal end, the second blade comprising a curved intermediate section between the proximal and distal ends,wherein the distal end of the second blade is configured to engage with the second side of the first screw head;wherein when the distal ends of the first and second blades are engaged with the first screw head:an inner surface of the first blade faces an inner surface of the second blade and is spaced therefrom; and the curved intermediate sections of the first and second blades form an enlarged opening with an increased spacing between the inner surfaces of the first and second blades relative to a spacing between the inner surfaces of the first and second blades proximal and distal to the intermediate sections.2. The system of Embodiment 1, wherein each of the first blade and the second blade comprises a proximal section and a distal section, wherein the intermediate section is 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 of any one of the preceding Embodiments, wherein the enlarged opening is oriented at an angle relative to the first and second longitudinal axes when the distal ends of the first and second blades are engaged with the first screw head.4. The system of any one of the preceding Embodiments, wherein the enlarged opening is oriented parallel or substantially parallel to the inner surfaces of the first and second blades.5. The system of any one of the preceding Embodiments, wherein the first and second longitudinal axes are parallel to one another when the distal ends of the first and second blades are engaged with the first screw head.6. The system of any one of the preceding Embodiments, wherein each of the curved intermediate sections of the first and second blades is bowed outward.7. The system of any one of the preceding Embodiments, wherein each of the first and second blades has a substantially uniform cross-sectional thickness from the proximal end to the distal end.8. The system of any one of the preceding Embodiments, further comprising:a second screw comprising a second screw head, the second screw head comprising a first side and a second side, the first side and the second side opposite each other;a second guiding element configured to extend away from the second screw, wherein the second guiding element comprises: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 the first side of the second screw head, anda fourth blade extending along a fourth longitudinal axis between a proximal end and a distal end, wherein the distal end of the fourth blade is configured to engage with the second side of the second screw head;wherein the enlarged opening between the first and second blades is sized and configured to allow for passage of the second screw and the second guiding element therethrough.9. The system of Embodiment 8, wherein the third blade of the second guiding element comprises a curved intermediate section between the proximal and distal ends, and the fourth blade of the second guiding element comprises a curved intermediate section between the proximal and distal ends, and wherein when the distal ends of the third and fourth blades are engaged with the second screw head:an inner surface of the third blade faces an inner surface of the fourth blade and is spaced therefrom; andthe curved intermediate sections of the third and fourth blades form an enlarged opening with an increased spacing between the inner surfaces of the third and fourth blades relative to a spacing between the inner surfaces of the third and fourth blades proximal and distal to the intermediate sections.10. The system of Embodiment 9, wherein a distance of the increased spacing between the inner surfaces of the third and fourth blades is less than a distance of the increased spacing between the inner surfaces of the first and second blades.11. The system of Embodiment 9 or 10, wherein an orientation of the enlarged opening between the third and fourth blades is different from the orientation of the enlarged opening between the first and second blades.12. The system of any one of Embodiment 9-11, wherein a longitudinal position of the enlarged opening between the third and fourth blades is different from a longitudinal position of the enlarged opening between the first and second blades.13. The system of Embodiment 8, wherein each of the third and fourth blades of the second guiding element are entirely planar or entirely substantially planar from the proximal end to the distal end.14. The system of any one of Embodiments 8-13, further comprising:a third screw comprising a third screw head, the third screw head comprising a first side and a second side, the first side and the second side opposite each other;a third guiding element configured to extend away from the third screw, wherein the third guiding element comprises:a fifth blade extending along a fifth longitudinal axis between a proximal end and a distal end, the fifth blade comprising a curved intermediate section between the proximal and distal ends, and wherein the distal end of the fifth blade is configured to engage with the first side of the third screw head,a sixth blade extending along a second longitudinal axis between a proximal end and a distal end, the sixth blade comprising a curved intermediate section between the proximal and distal ends, wherein the distal end of the sixth blade is configured to engage with the second side of the third screw head;wherein when the distal ends of the fifth and sixth blades are engaged with the third screw head:an inner surface of the fifth blade faces an inner surface of the sixth blade and is spaced therefrom;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 a spacing between the inner surfaces of the fifth and sixth blades proximal and distal to the intermediate sections; anda distance of the increased spacing between the inner surfaces of the fifth and sixth blades is greater than a distance of the increased spacing between the inner surfaces of the first and second blades, such that the enlarged opening between the fifth and sixth blades is sized and configured to allow for passage of the second screw and the second guiding element therethrough and to allow for passage of the first screw and the first guiding element therethrough.15. A system for bone stabilization, comprising:a plurality of guiding elements, wherein each of the plurality of guiding elements comprises:a first blade comprising a proximal end and a distal end, the first blade comprising a curved intermediate section between the proximal and distal ends; anda second blade comprising proximal end and a distal end, the second blade comprising a curved intermediate section between the proximal and distal ends;wherein the distal ends of the first and second blades are configured to engage with a bone screw such that, when engaged with the bone screw:an inner surface of the first blade faces an inner surface of the second blade and is spaced therefrom; andthe curved intermediate sections of the first and second blades form an enlarged opening with an increased spacing between the inner surfaces of the first and second blades relative to a spacing between the inner surfaces of the first and second blades proximal and distal to the intermediate sections;wherein the first and second blades of a first of the plurality of guiding elements form an enlarged opening having a different longitudinal position, a different spacing between the inner surfaces of the first and second blades, and/or a different orientation as compared to the enlarged opening formed by the first and second blades of a second of the plurality of guiding elements.16. The system of Embodiment 15, wherein the first and second blades of a third of the plurality of guiding elements form an enlarged opening having a different longitudinal position, a different spacing between the inner surfaces of the first and second blades, and/or a different orientation as compared to the enlarged opening formed by the first and second blades of the second of the plurality of guiding elements and as compared to the enlarged opening formed by the first and second blades of the first of the plurality of guiding elements.17. The system of Embodiment 16, wherein the first and second blades of a fourth of the plurality of guiding elements form an enlarged opening having a different longitudinal position, a different spacing between the inner surfaces of the first and second blades, and/or a different orientation as compared to the enlarged opening formed by the first and second blades of the third of the plurality of guiding elements, as compared to the enlarged opening formed by the first and second blades of the second of the plurality of guiding elements, and as compared to the enlarged opening formed by the first and second blades of the first of the plurality of guiding elements.18. The system of Embodiment 17, wherein the first and second blades of a fifth of the plurality of guiding elements form an enlarged opening having a different longitudinal position, a different spacing between the inner surfaces of the first and second blades, and/or a different orientation as compared to the enlarged opening formed by the first and second blades of the fourth of the plurality of guiding elements, as compared to the enlarged opening formed by the first and second blades of the third of the plurality of guiding elements, as compared to the enlarged opening formed by the first and second blades of the second of the plurality of guiding elements, and as compared to the enlarged opening formed by the first and second blades of the first of the plurality of guiding elements.
Systems, Devices and Methods ofFIGS.6A-6V

Embodiments disclosed herein are directed to a system600for stabilizing spinal vertebrae through a skin incision S. In any embodiments disclosed herein, any components, features, or other details of the system600can have any of the components, features, or other details of any other system embodiments disclosed herein or be used according to any of the steps of any other method embodiments disclosed herein, including without limitation any of the embodiments of the system200,300,400and/or500or methods of use thereof described above, in any combination with any of the components, features, or details of the system600or methods of use disclosed below. Similarly, any components, features, steps, or other details of any of the other system or method embodiments disclosed herein can have any of the components, features, steps, or other details of any embodiments of the system600or methods of use thereof disclosed herein in any combination with any of the components, features, or details of the system.

In any embodiments disclosed herein, the system600can have guiding elements that have varying widths or spacing between the blades of the guiding elements. The spacing between the blades can be sized and configured to allow other screws and towers or other guiding elements or extensions to pass between the blades thereof.

In some embodiments, the system600can include a first screw612that can include a first screw head613, the first screw head613including a first side and a second side, the first side and the second side being opposite each other, and a first guiding element610configured to extend away from the first screw head613. In any embodiments disclosed herein, the first guiding element610can include a first pair of blades618extending along a first longitudinal axis between a proximal end610aand a distal end610bof the first guiding element610. The first pair of blades618can include a transition portion616between the proximal end610aand a distal end610bof the first guiding element610wherein a first spacing (also referred to herein as a separation distance) between an inside surface of the first pair of blades618in the transition portion616increases such that a proximal spacing between the first pair of blades at the proximal end610aof the first guiding element610is greater than a distal spacing between the first pair of blades618at the distal portion610bof the first guiding element. The distal end610bof the first pair of blades618can be configured to engage with or couple with the first screw head613.

The system600can further include a second screw622that can include a second screw head623, the second screw head623including a first side and a second side, the first side and the second side being opposite each other, and a second guiding element620configured to extend away from the second screw head623. In some embodiments, the second guiding element620can have straight blades. In any embodiments disclosed herein, the second guiding element620can include a second pair of blades628extending along a second longitudinal axis between a proximal end620aand a distal end620bof the second guiding element620. The second pair of blades628can include a transition portion626between the proximal end620aand a distal end620bof the second guiding element620wherein a second spacing (also referred to herein as a separation distance) between an inside surface of the second pair of blades628in the transition portion626increases such that a proximal spacing between the second pair of blades628at the proximal end620aof the second guiding element620is greater than a distal spacing between the second pair of blades628at the distal portion620bof the second guiding element620. The distal end620bof the second pair of blades628can be configured to engage with or couple with the second screw head622.

In any embodiments disclosed herein, the second spacing between the second pair of blades628can be less than the first spacing between the first pair of blades618. In this configuration, the second guiding element620can be advanced through the first spacing between the first pair of blades618of the first guiding element610.

Some embodiments of the system600can further include a third screw632that can include a third screw head633, the third screw head633including a first side and a second side, the first side and the second side being opposite each other, and a third guiding element630configured to couple with and extend away from the third screw head633. In some embodiments, the third guiding element630can have straight blades. In any embodiments disclosed herein, the third guiding element630can include a third pair of blades638extending along a third longitudinal axis between a proximal end630aand a distal end630bof the third guiding element630. The third pair of blades638can include a transition portion636between the proximal end630aand a distal end630bof the third guiding element630wherein a third spacing (also referred to herein as a separation distance) between an inside surface of the third pair of blades638in the transition portion636increases such that a proximal spacing between the third pair of blades638at the proximal end630aof the third guiding element630is greater than a distal spacing between the third pair of blades638at the distal portion630bof the third guiding element630. The distal end630bof the third pair of blades638can be configured to engage with or couple with the third screw head632.

In any embodiments disclosed herein, the third spacing between the third pair of blades638can be less than the second spacing between the second pair of blades624. Further, the third spacing between the third pair of blades638can be less than the first spacing between the first pair of blades614. In this configuration, the second guiding element620and the third guiding element630can be advanced through the first spacing between the first pair of blades in the first guiding element614.

In any embodiments, the transition portion of the first guiding element610, the second guiding element620, the third guiding element630, and/or any guiding element can be angled outwardly away from the longitudinal centerline axis, or bowed outwardly away from the longitudinal centerline axis, and can be straight along a length of the transition section, can be curved along a length of the transition section, or otherwise. Further, in any embodiments disclosed herein, each of the first pair of blades618, the second pair of blades624, the third pair of blades638, and/or any blade of any guiding element disclosed herein can have a substantially uniform cross-sectional thickness from the proximal end to the distal end. In any embodiments disclosed herein, proximal portions of the first, second, and/or third pair of blades (i.e., from the proximal end to the proximal end of the transition portion) can be straight, planar, substantially straight, and/or substantially planar. Further, each of the blades of the proximal portions of the first, second, and/or third pair of blades can be parallel or substantially parallel to each other.

In some embodiments, the third spacing between the inner surfaces of the third pair of blades638of the third guiding element630can be less than the second spacing between the inner surfaces of the second pair of blades624of the second guiding element620by 25% (or approximately 25%), or from 15% (or approximately 15%) to 35% (or approximately 35%) or more. In any embodiments disclosed herein, the third spacing of the third guiding element630can be less than the second spacing of the second guiding element620by an amount that is greater than a thickness of each of the blades of the third pair of blades638. Further, the second spacing between the inner surfaces of the second pair of blades628of the second guiding element620can be less than the first spacing between the inner surfaces of the first pair of blades614of the first guiding element610by 25% (or approximately 25%), or from 15% (or approximately 15%) to 35% (or approximately 35%) or more. In any embodiments disclosed herein, the second spacing of the second guiding element620can be less than the first spacing of the first guiding element620by an amount that is greater than a thickness of each of the blades of the second pair of blades628.

In any embodiments disclosed herein, the guiding elements can have any of a range of lengths suitable for a range of differently sized anatomies, thereby permitting a surgeon to choose the desired length or lengths of the blades and positions of the enlarged openings after measurement of the depth of the tissue, for example.

Further, as shown inFIG.6A, any embodiments of the system600can further have a restraint650configured to engage the first pair of blades618and/or the second pair of blades628. In some embodiments, the restraint can be configured to engage an intermediate portion of the first pair of blades618, the second pair of blades628, and/or the third pair of blades638. The restraint650can be configured in some embodiments to at least create a hinge point or fulcrum between the first, second, and/or third guiding elements610,620,630. In some embodiments, the restraint650can be configured to surround at least the first, second, and/or third guiding elements610,620,630at intermediate portions thereof when the first, second, and/or third guiding element610,620,630passes through a portion of the other or others of the first, second, and/or third guiding element610,620,630and when the first, second, and/or third guiding elements610,620,630are engaged with the first, second, and/or third bone screws, respectively, and first, second, and/or third bone screws are implanted within a patient.

In some embodiments, the restraint650can be configured to limit relative movement between the first, second, and/or third guiding elements610,620,630, and/or to restrain the first, second, and/or third guiding elements610,620,630at an intermediate portion thereof so that the first, second, and/or third guiding elements610,620,630are hinged or rotatably restrained to one another at the intermediate portion thereof. In any embodiments disclosed herein, the restraint650can be positioned at or approximately at the intersection of the first, second, and/or third guiding elements610,620,630.

In some embodiments, the restraint650can be a ring configured to engage an outer portion along an intermediate portion of or intersection of the first, second, and/or third guiding elements610,620,630. With reference toFIG.6F, some embodiments of the restraint650can have an annular portion652(that can be permanently closed or openable, like a carbineer, hook, or keychain), a first and/or a second pin654, and/or a first and a second restraint bars658. In other embodiments, the restraint650can be configured such that the annular portion652coincides with the restraint bars652such that separate restraint bars are not needed. Any embodiments of the restraint650can be rigid and can be made from metal, plastic, rubber, or a composite material.

With reference toFIG.6G, some embodiments of the first pair of blades618can include a plurality of holes660configured to receive pins654of the restraint650. The restraint650can be selectively openable so that the restraint650can open to be advanced around the first, second, and/or third pair of blades, and closable to restrain the first, second, and/or third pair of blades.

Additionally, as shown inFIG.6Mon, any embodiments of the system600can further include caps680,682,684configured to be secured at the proximal ends of the first, second, and/or third pair of blades. The caps can provide an interface for other tools and devices, or robotic grippers, such as is shown inFIGS.6S-6V. Additionally, some embodiments of the caps can be configured to limit relative movement of the first, second, and/or third pair of blades.

In some embodiments, the system can include a cap that extends from the proximal end of at least one of the first and the second pair of blades to an intermediate portion along at least one of the first and second pair of blades, the cap configured to block relative movement between the first and second pair of blades. Caps can be screwed on or otherwise attached to secure or lock the two blades together. By locking the blades together, an extension system comprising two blades is essentially turned into a tower by stabilizing the proximal ends of the blades. The difference between blades and a tower is essentially a connection of the proximal ends of the blades thereby stabilizing the blades on the distal and proximal ends. In some embodiments, the caps can be slid on, snapped on, screwed on or otherwise coupled with the proximal tips of the blades to stabilize the blades and/or to limit movement between different pairs of blades.

For example, with reference toFIG.60, the first cap680coupled with a proximal end of the first guide element610can have a length that extends to a point where a distal edge or portion680bof the cap680contacts the second guiding element620and the third guiding element630to provide an edge about which the second and the third guiding elements620,630can rotate. Alternatively, as shown inFIG.6P, the second cap682and the third cap684can have a length that extends to a point where a distal edge or portion682bof the second cap682and/or a distal edge or portion684bof the third cap684can contact the first guiding element610to provide an edge about which the second and the third guiding elements620,630can rotate. Some embodiments of the system600can include a tool690configured to manipulate the proximal ends of the first, second, and/or third pair of blades to cause compression of a first, second, and/or third vertebra that the first, second, and/or third screw heads are respectively implanted into. Further, in any embodiments disclosed herein, a rod or connecting element670can be coupled with and of the first, second, and/or third the screw heads.

In this manner, the tool690coupled with caps680,682,684, can allow for a single system to align the screw heads, provide a channel to insert the connecting element (rod), reduce the screw in settings of spondylolisthesis (FIGS.6U and6V), placement of locking cap, final tightening of the lock cap under compression, and/or counter torqueing of the rod and screw construct when locking cap is final tightened. In some embodiments, no other additional tools such as head turner, compressor, or countertorque tools are necessary.

Certain aspects of the systems, devices, components and/or methods described above or as illustrated with respect toFIGS.6A-6Vare also encompassed by the following numbered embodiments. These numbered embodiments are considered to be directed to systems, devices, components and/or methods that include but are not limited to the embodiments ofFIGS.6A-6V, and thus these numbered embodiments may encompass other embodiments as described throughout this specification.1. A system for bone stabilization, comprising:a first guiding element comprising a first pair of blades extending at least partially along a first longitudinal axis, wherein each blade of the first pair of blades has a proximal end and a distal end, the distal ends of the first pair of blades configured to engage with a first bone screw, wherein each blade of the first pair of blades comprises a portion that deviates away from the first longitudinal axis to increase a separation distance between the first pair of blades when the distal ends of the first pair of blades are engaged with the first bone screw;a second guiding element comprising a second pair of blades extending at least partially along a first longitudinal axis, wherein each blade of the second pair of blades has a proximal end and a distal end, the distal ends of the second pair of blades configured to engage with a second bone screw, wherein each blade of the second pair of blades comprises a portion that deviates away from the second longitudinal axis to increase a separation distance between the second pair of blades when the distal ends of the second pair of blades are engaged with the second bone screw;wherein the separation distance between the second pair of blades is less than the separation distance between the first pair of blades.2. The system of Embodiment 1, further comprising:a third guiding element comprising a third pair of blades extending at least partially along a third longitudinal axis, wherein each blade of the third pair of blades has a proximal end and a distal end, the distal ends of the third pair of blades configured to engage with a third bone screw, wherein each blade of the third pair of blades comprises a portion that deviates away from the third longitudinal axis to increase a separation distance between the third pair of blades when the distal ends of the second pair of blades are engaged with the second bone screw;wherein the separation distance between the third pair of blades is less than the separation distance between the second pair of blades.3. The system of Embodiment 1 or 2, further comprising a restraint configured to engage an intermediate portion along either or both of the first pair of blades and the second pair of blades and limit relative movement between the first and second pair of blades.4. The system of Embodiment 3, wherein the restraint is a ring configured to engage an outer portion along an intermediate portion of the first pair of blades.5. The system of Embodiment 4, wherein the first pair of blades comprises a plurality of holes configured to receive pins on the ring.6. The system of any one of Embodiments 3-5, wherein the restraint is adjustable to close around the intermediate portion along the first pair of blades.7. The system of any one of the previous Embodiments, further comprising caps configured to be secured at the proximal ends of the first and second pair of blades to limit relative movement of each of the first and second pair of blades.8. The system of any one of Embodiments 1-3, further comprising a cap that extends from the proximal end of at least one of the first and the second pair of blades to an intermediate portion along at least one of the first and second pair of blades, the cap configured to block relative movement between the first and second pair of blades.9. The system of any one of the previous Embodiments, further comprising a tool configured to manipulate the proximal ends of the first and second pair of blades to cause compression of the first and second screw heads.10. A system for bone stabilization, comprising:a first guiding element extending at least partially along a first longitudinal axis and having a proximal end and a distal end, the distal end of the first guiding element configured to engage with a first bone screw;a second guiding element extending at least partially along a second longitudinal axis and having a proximal end and a distal end, the distal end of the second guiding element configured to engage with a second bone screw, wherein the second guiding element is configured to pass through a portion of the first guiding element when the first and second guiding elements are engaged with the first and second bone screws, respectively, and the first and second bone screws are implanted within a patient; anda restraint configured to surround at least one of the first and second guiding elements at intermediate portions thereof when the second guiding element passes through a portion of the first guiding element and when the first and second guiding elements are engaged with the first and second bone screws, respectively, and the first and second bone screws are implanted within a patient, wherein the restraint is configured to limit relative movement between the first and second guiding elements.11. The system of Embodiment 10, wherein the restraint is a ring.12. The system of Embodiment 10 or 11 wherein the restraint is adjustable to close around the first and second guiding elements.13. The system of Embodiment 10, wherein the restraint comprises a cap extending distally from the proximal end of at least one of the first and second guiding elements.14. The system of any one of Embodiments 10-13, further comprising a tool configured to manipulate the proximal ends of the first and second guiding elements when the second guiding element passes through a portion of the first guiding element and when the first and second guiding elements are engaged with the first and second bone screws, respectively, and the first and second bone screws are implanted within a patient.15. The system of any one of Embodiments 10-14, further comprising a third guiding element extending at least partially along a third longitudinal axis and having a proximal end and a distal end, the distal end of the third guiding element configured to engage with a third bone screw, wherein the third guiding element is configured to pass through a portion of the second guiding element when the first, second and third guiding elements are engaged with the first, second and third bone screws, respectively, and the first, second and third bone screws are implanted within a patient.
Systems, Devices and Methods ofFIGS.7A-7H

Additional embodiments a device700(also referred to herein as a guidance tool or a guidance tool for delivering screws) for implanting screws spinal vertebrae through a skin incision S will now be described. In some embodiments, the device700can be used to sweep away or move tissue away from the target screw location using a hinged or rotatable blade. In some embodiments, the device can have a ring with a handle having a hinge with an extension that opens to spread out the tissue and clear the path to place the second screw. The second screw can be placed through the same incision through the “ring” or portal of the first screw guided by the tissue sweeper guide. With reference toFIGS.7C-7E,FIG.7Cshows a closed tube702attached to the first screw705. The device700can be inserted as one piece. The second blade704(also referred to herein as a tissue sweeper) can be opened as shown inFIG.7D. Then, the second screw707can be inserted, as shown inFIG.7E. The second screw can be attached to a tower, for example any of the towers, extensions, or guide elements of any of the embodiments disclosed herein. The rod or connecting element can then be inserted in a manner similar to any of the embodiments disclosed herein. The embodiments of the device700can also be used with or configured for use with robotic attachments or robotic surgical systems.

FIGS.7F-7Hillustrate an alternative version of the hinged tissue sweeper or device700. In the embodiments shown therein, the blades702,704and the handles712,714do not cross sides. In other words, the handle712for the main tube702stays on the side of the main tube702, which can increase the strength of the handle712and/or handle714and the device700in this configuration. A hinge730can be placed more superiorly and to the edge of the tube on the side of the sweeper (i.e., the second blade704) to optimize the opening of the insertion of the second screw after the tissue sweeper700has been opened.

In any embodiments disclosed herein, any components, features, or other details of the device700can have any of the components, features, or other details of any other device embodiments disclosed herein, including without limitation any of the embodiments of the devices of system200,300,400,500and/or600described above, in any combination with any of the components, features, or details of the device700disclosed below. Similarly, any components, features, or other details of any of the other device embodiments disclosed herein can have any of the components, features, or other details of any embodiments of the device700disclosed herein in any combination with any of the components, features, or details of the embodiments of the device700.

In any embodiments disclosed herein, the device700can have a first blade702and a second blade704, wherein the first blade702(also referred to herein as a first tube) can have a proximal end702a, a distal end702b, an inner surface702c, and an outer surface702d, and the second blade704can have a proximal end704a, a distal end704b, an inner surface704c, and an outer surface704d. In any embodiments disclosed herein, the device can have a hinge730. The second blade704can be rotatably coupled with the first blade702using the hinge730. The hinge730can include a shaft or rod, or a pin.

In some embodiments, with reference toFIG.7C, the distal end of the first blade702can be configured to engage with a first bone screw705. In any embodiments disclosed herein, the first and second blades702,704can be moveable from a first configuration or position (as shown inFIG.7A) in which the first and second blades702,704form an at least partially enclosed passageway defined by the inner surfaces702c,704cof the first and second blades702,704extending along a longitudinal axis or axial centerline C parallel to each of the first and second blades702,704, and a second configuration or position (as shown inFIG.7B) in which the distal end704bof the second blade704pivots relatively away from the distal end702bof the first blade702.

The first handle712can be connected to the proximal end702aof the first blade702. In some embodiments, the first handle712can be integrally formed with the first blade702. The first handle712can extend at a first angle A1relative to the longitudinal axis C when the first and second blades702,704are in the first configuration. The second handle714can be connected to the proximal end704aof the second blade704. In some embodiments, the second handle714can be integrally formed with the first blade704. The second handle714can extend at a second angle A2relative to the longitudinal axis C when the first and second blades702,704are in the first configuration. In some embodiments, the first and the second angles A1, A2can diverge from each other on opposite sides of the longitudinal axis C. In some embodiments, the first and second angles can be fixed.

In some embodiments, when the device700is in the second configuration, with the first blade702remaining generally parallel to the longitudinal axis C of the passageway and the second blade704extending away from the longitudinal axis C on a first side of the longitudinal axis C, and the second handle714can extend away from the longitudinal axis C on a second side of the longitudinal axis C opposite to the first side of the longitudinal axis C (as shown inFIG.7B).

In other embodiments, with the first handle712of the first blade702extending away from the longitudinal axis C on the first side of the longitudinal axis C in the second configuration and with the first blade702remaining parallel to the longitudinal axis C of the passageway, the second blade704can extend away from the longitudinal axis C on a first side of the longitudinal axis C, and the second handle714can extend away from the longitudinal axis C on the first side of the longitudinal axis C (as shown inFIGS.7F and7H). In some embodiments, the handle of the first blade702can extend away from the longitudinal axis on the second side of the longitudinal axis.

In some embodiments, the enclosed passageway defined by the inner surfaces of the first and second blades702,704can be tubular, and the inner surfaces702c,704cof the first and second blades702,704can be concave. Some embodiments of the device700can include a partial or complete ring surrounding the proximal ends702a,704aof the first and second blades702,704.

In some embodiments, the blade704can be used as a tissue sweeper as the blade704is opened from a closed position to an open position. However, then after the second screw707is inserted, then the blade704can be used as a compressor and even a counter torque. By adjusting the proximal handles712and714either closer together or farther apart (depending on the configuration of the blades if they cross sides or stay on the same side as the distal portion they are connected to), then compression of both screws705and707can be performed. Preferably blade704has a distal notch similar to notch354inFIG.3B, andFIG.481inFIG.4C. The blade704can also be wider in the distal margin to “hold” the screw head of screw707. Preferably there is a corresponding notch at the distal tip of702bto hold the rod as well. The notches at the tip of both distal arms (704band702b) hold the rod to be used as a counter-torque when the locking nut is tightened to the final torque when locking the connecting element/rod into the heads of the screw heads.

An embodiment of a method of delivering screws to a spinal location using any of the embodiments of the guidance tool or device700disclosed herein will now be described. With reference toFIGS.7C-7E, a surgeon can deliver the guidance tool700to the desired or target spinal location so that the first blade702of the guidance tool700is engaged with a first bone screw implanted within a first vertebra. The surgeon can use the first and second handles712,714to move the first and second blades702,704from the first configuration to the second configuration so that that the distal end of the second blade704pivots away from the first blade702while the first blade702is engaged with the first bone screw. The surgeon can then deliver a second bone screw707between the proximal ends702a,704aof the first and second blades702,704and between the inner surfaces702c,704cof the first and second blades702,704and into a second vertebra.

Certain aspects of the systems, devices, components and/or methods described above or as illustrated with respect toFIGS.7A-7Hare also encompassed by the following numbered embodiments. These numbered embodiments are considered to be directed to systems, devices, components and/or methods that include but are not limited to the embodiments ofFIGS.7A-7H, and thus these numbered embodiments may encompass other embodiments as described throughout this specification.1. A guidance tool for delivering screws to a spinal location, the guidance tool comprising:a first blade and a second blade, each of the first blade and the second blade having a proximal end, a distal end, an inner surface and an outer surface, the distal end of the first blade being configured to engage with a first bone screw, wherein the first and second blades are moveable from a first configuration in which the first and second blades form an at least partially enclosed passageway defined by the inner surfaces of the first and second blades extending along a longitudinal axis parallel to each of the first and second blades, and a second configuration in which the distal end of the second blade pivots relatively away from the distal end of the first blade;a first handle connected to the proximal end of the first blade, the first handle extending at a first angle relative to the longitudinal axis when the first and second blades are in the first configuration; anda second handle connected to the proximal end of the second blade, the second handle extending at a second angle relative to the longitudinal axis when the first and second blades are in the first configuration, wherein the first and the second angle diverge from each other on opposite sides of the longitudinal axis.2. The guidance tool of Embodiment 1, wherein in the second configuration, with the first blade remaining parallel to the longitudinal axis of the passageway, the second blade extends away from the longitudinal axis on a first side of the longitudinal axis, and the second handle extends away from the longitudinal axis on a second side of the longitudinal axis opposite to the first side.3. The guidance tool of Embodiment 2, wherein the handle of the first blade extends away from the longitudinal axis on the first side of the longitudinal axis.4. The guidance tool of Embodiment 1, wherein in the second configuration, with the first blade remaining parallel to the longitudinal axis of the passageway, the second blade extends away from the longitudinal axis on a first side of the longitudinal axis, and the second handle extends away from the longitudinal axis on the first side of the longitudinal axis.5. The guidance tool of any one of Embodiment 4, wherein the handle of the first blade extends away from the longitudinal axis on the second side of the longitudinal axis.6. The guidance tool of any one of Embodiments 1-5, wherein the enclosed passageway defined by the inner surfaces of the first and second blades is tubular.7. The guidance tool of any one of Embodiments 1-6, wherein the inner surfaces of the first and second blades are concave.8. The guidance tool of any one of Embodiments 1-7, further comprising a partial or complete ring surrounding the proximal ends of the first and second blades.9. The guidance tool of any one of Embodiments 1-8, wherein the first and second angles are fixed.10. A method of delivering screws to a spinal location using the guidance tool of any one of Embodiments 1-9, comprising:delivering the guidance tool to the spinal location so that the first blade of the guidance tool is engaged with a first bone screw implanted within a first vertebra;using the first and second handles to move the first and second blades from the first configuration to the second configuration so that that the distal end of the second blade pivots away from the first blade while the first blade is engaged with the first bone screw; anddelivering a second bone screw between the proximal ends of the first and second blades and between the inner surfaces of the first and second blades and into a second vertebra.
Systems, Devices and Methods ofFIGS.8A-9P

Embodiments disclosed below and shown inFIGS.8A-8Gare related to show embodiments of a guidance tool1500for delivering screws to a spinal location. Sacroiliac (SI) fusion has been shown to be a useful and necessary adjunct to lumbar fusion. The SI joint is the next “joint” inferior to the L5-S1 joint. SI fusion usually requires placing 2-3 triangular metal implants (SI Fuse) through the iliac bone into the sacrum. By crossing the SI joint, the implants can stabilize the SI joint.

Conventional devices incorporate screws instead of triangular implants. In the conventional methods, each screw is usually placed individually in succession. The screws can be fully threaded or a lag screw with threads only in the sacral portion. Each screw typically requires a sequence of fluoroscopic images to position the trajectory of the screw in the correct 3 D position, which can be very time consuming and expose the patient to increased risks.

In some embodiments of the guidance tool1500, by arranging three trajectories starting from a single incision at the skin, all three trajectories can be angled out to a small extent bit from the incision. Embodiments of the guidance tool1500can allow all three trajectories to be identified and confirmed in 3D space all at the same time (simultaneously), thus saving radiation from fluoroscopy and considerable time in surgery. All three screw trajectories can essentially be identified at the same time instead of serially—one after the other—of the conventional methods.

FIGS.8C-8Dshow the guidance tool1500, showing a trajectory view of the three implant trajectories. The three implants can be triangulated like shown in these figures, but can also be arranged in a linear pattern with all three implants in a single line or generally coaxially aligned.FIG.8Eshows a typical trajectory of the typical SI screw implant using the guidance tool1500.

With reference toFIGS.8F-8G, the three trajectories of the guidance tool1500are opened (or at least partially opened). All three trajectories of the guidance tool1500can be identified and verified by fluoroscopic guidance or intraoperative stereotactic navigation. The alignment of the trajectories of the guidance tool1500can be offset such as the corners of a flat triangle, but the trajectories can be linearly arranged also.

In any embodiments disclosed herein, the guidance tool1500can include a first handle1502coupled with a first blade1512, a second handle1504coupled with a second blade1514, and a third handle1506coupled with a third blade1516. In some embodiments, the guidance tool1500can include only the first blade1512and the second blade1514. In some embodiments, each of the three blades1512,1514,1516can have a proximal end proximal ends1512a,1514a,1516a, a distal end proximal ends1512b,1514b,1516b, an inner surface and an outer surface, respectively. In some embodiments, the guidance tool1500can have two blades, or more than three blades. In any embodiments disclosed herein, the handles1502,1504,1506can extend at an angle from the proximal end(s)1512a,1514a,1516aof any one of the three blades1512,1514,1516. In some embodiments, a handle can extend from the proximal end1512a,1514a,1516aof all three blades1512,1514,1516. The handles1502,1504,1506can be used to pivot a corresponding blade from a first configuration or position to a second configuration or position.

Further, in any embodiments of the guidance tool1500, any of the three blades1512,1514,1516can have a guide1522,1524,1526(also referred to herein as a drill guide) coupled with an inside surface thereof, or integrally formed therewith. For example and without limitation, some embodiments of the guidance tool1500can have a guide1522,1524,1526on each of the three blades1512,1514,1516. Each of the guides1522,1524,1526can be positioned at a different longitudinal location along the respective blades along the passageway when the three blades1512,1514,1516are in the first configuration. In some embodiments, the three blades1512,1514,1516can form a completely enclosed tubular passageway in the first configuration.

In any embodiments disclosed herein, as in the illustrated embodiments, the guides1522,1524,1526can be enclosed, partially open, tubular, C-shaped, U-shaped, or have any other desired shape. In some embodiments, the guides1522,1524,1526can extend longitudinally along a majority of a length of the inner surface of a corresponding blade1512,1514,1516. Further, in some embodiments, the guides1522,1524,1526can be removably attachable to the inner surface of a corresponding blade1512,1514,1516.

In some embodiments, at least two of the three blades1512,1514,1516can be moveable from a first configuration (as shown inFIG.8A) in which each of the first, second and third blade1516can form an at least partially enclosed passageway defined by the inner surfaces of the three blades1512,1514,1516extending along a longitudinal axis parallel to each of the three blades1512,1514,1516, and a second configuration (as shown inFIG.8B) in which the distal ends of at least two of the three blades1512,1514,1516can be configured to pivot radially outward relative to their proximal ends1512a,1514a,1516a. In some embodiments, all three blades1512,1514,1516can be moveable between the first configuration and the second configuration, wherein in the second configuration the distal ends of all three blades1512,1514,1516pivot radially outward relative to their proximal ends1512a,1514a,1516a.

The guidance tool1500can, in some embodiments, can further include a mount1530coupled with the proximal ends1512a,1514a,1516aof the three blades1512,1514,1516, wherein the proximal ends1512a,1514a,1516aof at least two of the three blades1512,1514,1516can be pivotally connected to the mount1530. In some embodiments, as in the illustrate embodiments, the proximal ends1512a,1514a,1516aof all three blades1512,1514,1516can be pivotally connected to or coupled with the mount1530. In some embodiments, the mount1530can have a semi-circular shape that surrounds the proximal ends1512a,1514a,1516aof the three blades1512,1514,1516.

In any embodiments disclosed herein, each of the three blades1512,1514,1516can have a hinge, a bracket1532,1534,1536, respectively, or other components that are configured to pivotally engage with corresponding components or structures on the mount1530. A pin or a shaft can also be used to couple the blades1512,1514,1516and/or the brackets1532,1534,1536with the mount1536.

In some embodiments, the guidance tool1500can, in the first configuration, be delivered to a location adjacent the sacroiliac joint. In the second configuration, the three blades1512,1514,1516can provide a trajectory along the inner surfaces of the three blades1512,1514,1516for delivering three screws to the sacroiliac joint.

FIGS.9A-9Eshow an embodiment of a guidance tool1600for delivering pedicle screws. In any embodiments disclosed herein, any components, features, or other details of the guidance tool1600can have any of the components, features, or other details of any other guidance tool embodiments disclosed herein, including without limitation any of the embodiments of the guidance tool1500described above, in any combination with any of the components, features, or details of the guidance tool1600disclosed below. Similarly, any components, features, or other details of any of the other system embodiments disclosed herein can have any of the components, features, or other details of any embodiments of the guidance tool1600disclosed herein in any combination with any of the components, features, or details of the system.

The guidance tool is also referred to herein as a pedicle screw trajectory finder or a multi-prong trajectory finder. Currently, pedicle screw tracts are identified individually for each screw either by fluoroscopic guidance, stereotactic navigation, or by robotic guidance. Embodiments of the guidance tool1600disclosed herein allow the surgeon or robot to insert a tubular structure containing two or three drill guides into the screw through the muscle and then opened so that all two or three drill guides are adjusted at the same time for each fluoroscopic shot. The drill guide tubes can be clipped into the clips1622,1626coupled with or integrally formed with each of the blades1612,1616. Alternatively, in some embodiments, the blades1612,1614,1616can be elongated and extend all with way through the muscle and down to the bone. If a bilateral Wiltse approach is used, then two drill guides can be inserted simultaneously so that three screw trajectories can be adjusted at the same time for every fluoroscopy image taken. This would reduce the number of fluoroscopic images by up to 6×.

With reference toFIGS.9D and9E, the guidance tool1600can be inserted at the skin level and drill guides can be placed into the clips1622,1626of each blade1612,1616. In some embodiments, a drill guide can be positioned in the guide1624. The drill guides can be inserted together (closed) down through muscle and then opened similar to using a METRX dilator tube to dissect muscle off of bone. By placing the drill guide tubes down in a closed position then opening, this can help ensure that a single muscle plane contains all of the screws. Otherwise, the screws may be in different muscle planes which would require cutting of muscle when the rod or connecting element is inserted.

Also, this configuration of some embodiments allows for individual manipulation of each blade, permitting the robot to insert and open the blades and tubes to exact calculated positions and therefore trajectories of all three screws in one step. Thus, all screws trajectories can be identified in one step instead of three different steps, with some embodiments. Once drill guides are in the proper position, as confirmed by fluoroscopic or stereotactic navigation means, then a drill can be used to create pedicle screw trajectories for the placement of pedicle screws.

With reference toFIGS.9A-9E, some embodiments of the guidance tool1600for delivering pedicle screws can include blades1612,1614, and1616. Each of the three blades1612,1614,1616can have a proximal end, a distal end, an inner surface and an outer surface. At least two of the three blades1612,1614,1616(for example and without limitation, blades1612,1616) can be moveable from a first configuration in which each of the blades1612,1614,1616form an at least partially enclosed passageway defined by the inner surfaces of the three blades1612,1614,1616extending along a longitudinal axis parallel to each of the three blades1612,1614,1616, and a second configuration in which the distal ends of at least two of the three blades1612,1614,1616(for example and without limitation, blades1612,1616) pivot radially outward relative to their proximal ends1612a,1614a,1616a. In some embodiments, the three blades1612,1614,1616can be configured in the first configuration for delivery to a location adjacent a first pedicle, and the three blades1612,1614,1616can be configured in the second configuration to provide a trajectory along the inner surfaces of the three blades1612,1614,1616for delivering three screws to the first pedicle, a second pedicle superior to the first pedicle, and a third pedicle inferior to the first pedicle.

In some embodiments, the second blade1612and the third blade1616can be pivotable away from the first blade1614along a common plane. Further, some embodiments of the guidance tool1600can include a mount1630connected to the proximal ends1612a,1614a,1616aof the three blades1612,1614,1616, wherein the proximal ends1612a,1614a,1616aof at least two of the three blades1612,1614,1616can be pivotally connected to the mount1630. The mount1630can have an arm1632extending away from the proximal ends1612a,1614a,1616aof the three blades1612,1614,1616, the arm1632being configured to be secured relative to a table, a positioning arm, a robotic arm, or other support structure. The tool1600can include handles1602,1606extending at an angle from the proximal ends1612a,1616aof at least two of the three blades1612,1616, the handles1602,1606being usable to pivot a corresponding blade from the first configuration to the second configuration. In any embodiments, all three of the blades1612,1614,1616can further have a guide1622,1624,1626on the inner surface thereof, which guides1622,1624,1626can be attached to or integrally formed with the blades. Further, in any embodiments, each of the guides1622,1624,1626can be positioned at a different longitudinal location along the passageway when the three blades1612,1614,1616can be in the first configuration. In some embodiments, the guides1622,1624,1626can be tubular, C-shaped, U-shaped, enclosed, open, or otherwise.

FIGS.9F-9Mshow another embodiment of a guidance tool1700for delivering pedicle screws. The guidance tool is also referred to herein as a pedicle screw trajectory finder or a multi-prong trajectory finder. Currently pedicle screw tracts are identified individually for each screw either by fluoroscopic guidance, stereotactic navigation, or by robotic guidance. This pedicle finder guidance tool can allow the surgeon or robot to insert a tubular structure containing two or three drill guides into the screw through the muscle and then opened so that all two or three drill guides are adjusted/manipulated at the same time for each fluoroscopic shot. If a bilateral Wiltse approach is used, then two drill guides can be inserted simultaneously so that six pedicle screw trajectories (for example, three on each side) can be adjusted at the same time for every fluoroscopy image taken. This would reduce the number of fluoroscopic images by up to 6×. The drill guide tubes1722,1724,1726can be cylindrical and can be associated with or coupled with tissue spreaders. The purpose of expansion rather than inserting three tubes independently through muscle is that if all guide tubes on one side are inserted together initially and then opened, then the three tubes all occupy a single muscle plane. This spares any muscle cutting when the rod or connecting element is eventually inserted into the screw heads.

The guidance tool1700can be inserted at the skin level and drill guides can be placed into the clips of each blade. The drill guides can be inserted together (closed) down through muscle and then opened similar to using a Medtronic METRX dilator tube to dissect muscle off of bone. By placing the drill guide tubes down in a closed position then opening, this can help ensure that a single muscle plane contains all screws. Otherwise, screws may be in different muscle planes which would require cutting of muscle when the rod or connecting element is inserted. Handles1702,1704,1706on each of the guide tubes allow independent manipulation based on each fluoroscopic shot. If stereotactic navigation is used, then the trajectories can be manipulated continuously in response to the stereotactic guidance. The table arm bracket1732can allow the guidance tool1700to be stabilized in relation to the operating table. Also robotic manipulation of each blade can allow the robot to insert and open the blades1702,1704,1706and tubes to exact calculated positions and therefore trajectories of all three screws can be identified in one step instead of three different steps. Once drill guides are in the proper position as confirmed by fluoroscopic or stereotactic navigation means, then a drill can be used to create pedicle screw trajectories for the placement of pedicle screws. Planning all three trajectories simultaneously better ensures that the screw heads will be aligned. Typically, most pedicle screw trajectories are aligned in a gentle curve in the lumbar spine. Linear approximation of this curve is usually straight forward.

With reference toFIGS.9L-9M, the guide tubes can be opened and can be manipulated deeper or more superficial depending on bony artifacts, osteophytes, etc. Inner tubes inside the guide can be positioned to accommodate these depth variations.

In any embodiments disclosed herein, any components, features, or other details of the guidance tool1700can have any of the components, features, or other details of any other guidance tool embodiments disclosed herein, including without limitation any of the embodiments of the guidance tool1500,1600described above, in any combination with any of the components, features, or details of the guidance tool1700disclosed below. Similarly, any components, features, or other details of any of the other system embodiments disclosed herein can have any of the components, features, or other details of any embodiments of the guidance tool1700disclosed herein in any combination with any of the components, features, or details of the system.

In some embodiments, the guides1722,1724,1726can be cylindrical in shape and extend longitudinally along a majority of a length of the inner surface of a corresponding blade1712,1714,1716. In some embodiments, the guides1722,1724,1726can be positioned side-by-side in the first configuration. Further, in some embodiments, the guides1722,1724,1726can be removably attachable to the inner surface of a corresponding blade1712,1714,1716.

FIGS.9N-9Pshow another embodiment of a guidance tool1800for delivering pedicle screws. In any embodiments disclosed herein, any components, features, or other details of the guidance tool1800can have any of the components, features, or other details of any other guidance tool embodiments disclosed herein, including without limitation any of the embodiments of the guidance tool1500,1600, and/or1700described above, in any combination with any of the components, features, or details of the guidance tool1800disclosed below. Similarly, any components, features, or other details of any of the other system embodiments disclosed herein can have any of the components, features, or other details of any embodiments of the guidance tool1800disclosed herein in any combination with any of the components, features, or details of the system. A variation of the stage of the guide tubes1822,1824,1826allows each tube1822,1824,1826to be varied in multiple ° of freedom is necessary, independently of the other tubes. Preferably, a robot means allow calculated manipulation of the tubes1822,1824,1826.

Additionally, with reference toFIGS.9N-9P, some embodiments of the guidance tool1800can have a sliding hinge1840configured to permit the first blade1812to rotate and translate in an axial direction. For example and without limitation, in some embodiments, a bracket1838can be coupled with the first handle1802and/or first blade1812. With reference toFIG.90, in some embodiments, the second blade1814can be rotatable relative to the mount.

Certain aspects of the systems, devices, components and/or methods described above or as illustrated with respect toFIGS.8A-9Pare also encompassed by the following numbered embodiments. These numbered embodiments are considered to be directed to systems, devices, components and/or methods that include but are not limited to the embodiments ofFIGS.8A-9P, and thus these numbered embodiments may encompass other embodiments as described throughout this specification.1. A guidance tool for delivering screws to a spinal location, the guidance tool comprising:a first blade, a second blade and a third blade, each of the three blades having a proximal end, a distal end, an inner surface and an outer surface, wherein at least two of the three blades are moveable from a first configuration in which the first, second and third blades form an at least partially enclosed passageway defined by the inner surfaces of the three blades extending along a longitudinal axis parallel to each of the three blades, and a second configuration in which the distal ends of at least two of the three blades pivot radially outward relative to their proximal ends.2. The guidance tool of Embodiment 1, wherein all three blades are moveable from the first configuration to the second configuration, wherein in the second configuration the distal ends of all three blades pivot radially outward relative to their proximal ends.3. The guidance tool of Embodiment 1 or 2, further comprising a mount connected to the proximal ends of the three blades, wherein the proximal ends of at least two of the three blades are pivotally connected to the mount.4. The guidance tool of Embodiment 3, wherein the proximal ends of all three blades are pivotally connected to the mount.5. The guidance tool of Embodiment 3 or 4, wherein the mount has a semi-circular shape that surrounds the proximal ends of the three blades.6. The guidance tool of any one of the preceding Embodiments, further comprising a handle extending at an angle from the proximal ends of at least two of the three blades, the handle being usable to pivot a corresponding blade from the first configuration to the second configuration.7. The guidance tool of Embodiment 6, wherein a handle extends from the proximal end of all three blades.8. The guidance tool of any one of the preceding Embodiments, wherein at least two of the three blades further comprise a drill guide on the inner surface thereof.9. The guidance tool of any one of the preceding Embodiments, wherein all three of the blades further comprises a drill guide on the inner surface thereof.10. The guidance tool of any one of Embodiment 8 or 9, wherein each of the drill guides is positioned at a different longitudinal location along the passageway when the three blades are in the first configuration.11. The guidance tool of any one of Embodiments 8-10, wherein the drill guides are tubular.12. The guidance tool of any one of Embodiments 8-10, wherein the drill guides are C-shaped.13. The guidance tool of any one of Embodiments 8-12, wherein the drill guides extend longitudinally along a majority of a length of the inner surface of a corresponding blade.14. The guidance tool of any one of Embodiments 8-13, wherein the drill guides are removably attachable to the inner surface of a corresponding blade.15. The guidance tool of any one of the preceding Embodiments, wherein the three blades form a completely enclosed tubular passageway in the first configuration.16. A guidance tool for delivering screws to a sacroiliac joint, the guidance tool comprising:a first blade, a second blade and a third blade, each of the three blades having a proximal end, a distal end, an inner surface and an outer surface, wherein at least two of the three blades are moveable from a first configuration in which the first, second and third blades form an at least partially enclosed passageway defined by the inner surfaces of the three blades extending along a longitudinal axis parallel to each of the three blades, and a second configuration in which the distal ends of at least two of the three blades pivot radially outward relative to their proximal ends;wherein the three blades are configured in the first configuration for delivery to a location adjacent the sacroiliac joint, and the three blades are configured in the second configuration to provide a trajectory along the inner surfaces of the three blades for delivering three screws to the sacroiliac joint.17. The guidance tool of Embodiment 16, wherein all three blades are moveable from the first configuration to the second configuration, wherein in the second configuration the distal ends of all three blades pivot radially outward relative to their proximal ends.18. The guidance tool of Embodiment 16 or 17, further comprising a mount connected to the proximal ends of the three blades, wherein the proximal ends of at least two of the three blades are pivotally connected to the mount.19. The guidance tool of Embodiment 18, wherein the proximal ends of all three blades are pivotally connected to the mount.20. The guidance tool of Embodiment 18 or 19, wherein the mount has a semi-circular shape that surrounds the proximal ends of the three blades.21. The guidance tool of any one of Embodiments 16-20, further comprising a handle extending at an angle from the proximal ends of at least two of the three blades, the handle being usable to pivot a corresponding blade from the first configuration to the second configuration.22. The guidance tool of Embodiment 21, wherein a handle extends from the proximal end of all three blades.23. The guidance tool of any one of Embodiments 16-22, wherein all three of the blades further comprise a drill guide on the inner surface thereof.24. The guidance tool of Embodiment 23, wherein each of the drill guides is positioned at a different longitudinal location along the passageway when the three blades are in the first configuration.25. The guidance tool of any one of Embodiment 23 or 24, wherein the drill guides are tubular.26. The guidance tool of any one of Embodiment 23 or 24, wherein the drill guides are C-shaped.27. The guidance tool of any one of Embodiments 16-27, wherein the three blades form a completely enclosed tubular passageway in the first configuration.28. A guidance tool for delivering pedicle screws, comprising:a first blade, a second blade and a third blade, each of the three blades having a proximal end, a distal end, an inner surface and an outer surface, wherein at least two of the three blades are moveable from a first configuration in which the first, second and third blades form an at least partially enclosed passageway defined by the inner surfaces of the three blades extending along a longitudinal axis parallel to each of the three blades, and a second configuration in which the distal ends of at least two of the three blades pivot radially outward relative to their proximal ends;wherein the three blades are configured in the first configuration for delivery to a location adjacent a first pedicle, and the three blades are configured in the second configuration to provide a trajectory along the inner surfaces of the three blades for delivering three screws to the first pedicle, a second pedicle superior to the first pedicle, and a third pedicle inferior to the first pedicle.29. The guidance tool of Embodiment 28, wherein the second and third blades are pivotable away from the first blade along a common plane.30. The guidance tool of Embodiment 28 or 29, further comprising a mount connected to the proximal ends of the three blades, wherein the proximal ends of at least two of the three blades are pivotally connected to the mount.31. The guidance tool of Embodiment 30, wherein the mount comprises an arm extending away from the proximal ends of the three blades configured to be secured relative to a table.32. The guidance tool of any one of Embodiments 28-31, further comprising a handle extending at an angle from the proximal ends of at least two of the three blades, the handle being usable to pivot a corresponding blade from the first configuration to the second configuration.33. The guidance tool of any one of Embodiments 28-32, wherein all three of the blades further comprise a drill guide on the inner surface thereof.34. The guidance tool of Embodiment 33, wherein each of the drill guides is positioned at a different longitudinal location along the passageway when the three blades are in the first configuration.35. The guidance tool of Embodiment 33 or 34, wherein the drill guides are tubular.36. The guidance tool of Embodiment 33 or 34, wherein the drill guides are C-shaped.37. The guidance tool of any one of Embodiments 33-36, wherein the drill guides are cylindrical in shape and extend longitudinally along a majority of a length of the inner surface of a corresponding blade.38. The guidance tool of Embodiment 37, wherein the drill guides are positioned side-by-side in the first configuration.39. The guidance tool of any one of Embodiments 28-38, wherein the drill guides are removably attachable to the inner surface of a corresponding blade.
Systems, Devices and Methods ofFIGS.10A-10G

Additional embodiments of a system (e.g., system2000) that can be used for stabilizing or treating spinal vertebrae through a skin incision S are disclosed below. In any embodiments disclosed herein, any components, features, or other details of the system2000can have any of the components, features, or other details of any other system embodiments disclosed herein or be used according to any of the steps of any other method embodiments disclosed herein, including without limitation any of the embodiments of the system200,300, and/or400or methods of use thereof described above, in any combination with any of the components, features, or details of the system2000or methods of use disclosed herein. Similarly, any components, features, steps, or other details of any of the other system or method embodiments disclosed herein can have any of the components, features, steps, or other details of any embodiments of the system2000or methods of use thereof disclosed herein in any combination with any of the components, features, or details of the system.

Some embodiments of the system2000for stabilizing spinal vertebrae through a skin incision S can include a first screw2002having a first screw head, a second screw2004having a second screw head, a third screw2006having a third screw head, a first tower2012having a distal portion2012aand a proximal portion2012b, a second tower2014having a distal portion2014aand a proximal portion2014b, and a third tower2016having a distal portion2016aand a proximal portion2016b. Note that the first tower, second tower, and third tower can also be referred to herein as a first extension, second extension, and third extension. The first tower2012can be configured to be removably coupled with the first screw2002at a distal end2012aof the first tower2012, the second tower2014can be configured to be removably coupled with the second screw2004at a distal end2014aof the second tower2014, and third tower2016can be configured to be removably coupled with the third screw2006at a distal end2016aof the third tower2016. In some embodiments, each of the first, second, and third screws2002,2004,2006can be positioned in different vertebra. In some embodiments, each of the first, second, and third screws2002,2004,2006can be positioned in adjacent vertebra. In any embodiments disclosed herein, any of the extensions can also be referred to as guiding elements, towers, or by other suitable terms understood in the industry. Additionally, note that, while the embodiments of the system2000disclosed herein may have included screws as part of the system, any embodiments of the system2000disclosed herein can exclude the screws such that the embodiments of the system2000include the towers and/or other components other than the screws.

Some MIS pedicle screw systems use towers mechanically coupled to pedicle screws while other MIS pedicle screw systems use extended tabs or blades that are created in a single piece of metal. In the extended tabs case the blades are manufactured as part of the screw from one single piece of metal. There is usually a scored transition between the top of the screw and the extended blade. The scored transition allows the blade to snap off at the end of the fusion after the rod has been final locked in place. From a manufacturing perspective, extended tabs or blades are more expensive because of the extra metal needed to manufacture the blade or tab that is eventually broken off and wasted.

In any of the embodiments disclosed herein, the first, second, and third towers can be configured to be removably coupled with the screw heads and otherwise configured to be reuseable. This can save a significant cost as compared with disposable blade designs that, once the blade has been separated from the screw head, is typically discarded and not reused. From a surgical perspective, towers are more firm an rigid and can be used to provide rigidity to as to provide counter-torque during final tightening of the locking cap onto the rod in the screw head. Extended blades usually do not have the same strength as a counter-torque device. The towers of any of the embodiments disclosed herein, with the rigidity that they provide, can therefore help prevent the walls of the pedicle screw from splaying during final tightening of the locking cap.

The towers of some embodiments disclosed herein can provide a more complete enclosure than the blades or tabs can, due to the additional wall portions of the towers that extend between the sides of the towers. In some embodiments, as shown in the figures, the wall portions that extend between the two side wall portions to provide additional strength and stiffness can be integrally formed with the side wall portions, or can be separately formed and coupled (removably or nonremovably) with the side wall portions to provide additional rigidity to the towers.

In some embodiments, at least a portion of the distal portions of any embodiments of the first and/or third towers2012,2016can be enclosed about at least 320° (or at least approximately 320°) of the circumference or cross-section of the first and/or third towers2012,2016, or from 270° (or approximately 270°) to 330° (or approximately 330°, or at least 330°), or from 290° (or approximately 290°) to 320° (or approximately 320°), or enclosed about any value or range of value within the foregoing ranges. In some embodiments, at least a portion of the distal portions of any embodiments of the first and/or third towers2012,2016can be can be completely enclosed, with the exception of the channel extending lengthwise along at least the distal portion of the first and/or third towers2012,2016sized and configured to permit a passage of the rod or connecting element toward the screws. Additionally, for example and without limitation, at least a portion of the distal portion of any embodiments of the second tower2014can be enclosed about at least 270° (or at least approximately 270°) of the circumference or cross-section of the second tower2014, or from 240° (or approximately 240°) to 320° (or approximately 320°), or from 270° (or approximately 270°) to 300° (or approximately 300°), or enclosed about any value or range of value within the foregoing ranges. In some embodiments, at least a portion of the distal portion of any embodiments of the second tower2014can be can be completely enclosed, with the exception of a channel on each side of the distal portion2014bof the second tower2014extending lengthwise along at least the distal portion of the second tower2014sized and configured to permit a passage of the rod or connecting element toward the screws.

In some embodiments, at least a portion of the distal portions of any embodiments of the first and/or third towers2012,2016can be enclosed about at least 80% (or at least approximately 80%) of the circumference or cross-section of the first and/or third towers2012,2016, or from 70% (or approximately 70%) to 90% (or approximately 90%, or more than 90%—e.g., 95% or 100%), or from 75% (or approximately 75%) to 85% (or approximately 85%), or enclosed about any value or range of value within the foregoing ranges. Additionally, for example and without limitation, at least a portion of the distal portion of any embodiments of the second tower2014can be enclosed about at least 75% (or at least approximately 75%) of the circumference or cross-section of the second tower2014, or from 60% (or approximately 60%) to 80% (or approximately 80%), or from 65% (or approximately 65%) to 75% (or approximately 75%), or enclosed about any value or range of value within the foregoing ranges.

The additional wall portions of the towers disclosed herein are configured to prevent more muscle and tissue creep or invagination into the space within the tower or between the blades. For an MIS procedure in a large patient with excessive tissue, adipose tissue and muscle, a tower will protect the inside of the tower from tissue interference, whereas blades can allow tissue to creep in from both openings between the blades. In some embodiments, placement of the rod is then easier within a tower than using blades and there is a lower risk that patient tissue will be inadvertently severed or injured during rod placement. Placement of the rod using only blades often results in the rod getting “caught up” in the muscle that creeps into the opening between the blades.

In some embodiments, the first tower2012can have a slight bend between the distal portion2012aand the proximal portion2012bthereof. For example and without limitation, the distal portion2012acan be angled relative to the proximal portion2012bso that a longitudinal centerline of the proximal portion2012bhas an angle that is 20° or approximately 20° relative to a longitudinal centerline of the distal portion2012aof the first tower2012, or so that the longitudinal centerline of the proximal portion2012bhas an angle that is from 0° or approximately 0° to 40° or approximately 40°, or from 10° or approximately 10° to 30° or approximately 30° relative to the longitudinal centerline of the distal portion2012aof the first tower, or of any value or range of values within any of the foregoing ranges. In any embodiments, the second tower2014can be generally straight along a length thereof, as shown, or can have a bend between the distal portion2014aand the proximal portion2014bthereof.

In some embodiments, the third tower2016can have a bend between the distal portion2016aand the proximal portion2016bthereof. The bend in the third tower2016may be greater than the bend in the first tower2012. For example and without limitation, the distal portion2016acan be angled relative to the proximal portion2016bso that a longitudinal centerline of the proximal portion2016bhas an angle that is 85° or approximately 85° relative to a longitudinal centerline of the distal portion2016aof the third tower2016, or that is 90° or approximately 90° relative to a longitudinal centerline of the distal portion2016aof the third tower2016, or so that the longitudinal centerline of the proximal portion2016bhas an angle that is from 70° or approximately 70° to 110° or approximately 110°, or from 80° or approximately 80° to 100° or approximately 100° relative to the longitudinal centerline of the distal portion2016aof the first tower2012, or of any value or range of values within any of the foregoing ranges. In some embodiments, the bend between the distal and proximal portions of any of the towers can optionally be adjustable using an adjustable coupling such as a locking hinge.

Any embodiments of the system2000disclosed herein can be configured such that the first screw2002, the second screw2004, and the third screw2006can be implanted through the same skin incision S. Further, in any embodiments, a distal portion2014aof the second tower2014can be positioned between the distal portions2012a,2016aof the first and third towers2012,2016in an operable state of the system2000.

In some embodiments, the first tower2012can have a two or more proximal portions2012bextending away from the distal portion2012aof the first tower2012at a variety of angles. For example and without limitation, the two or more proximal portions2012bextending away from the distal portion2012aof the first tower2012can provide two or more separate handles extending away from the distal portion2012athat a surgeon can grasp and manipulate. In some embodiments, the first tower2012can removably couple with the first screw2002such that, when the first tower2012is coupled with the first screw2002, an axial or longitudinal centerline C of the distal portion2012aof the first tower2012is approximately collinear with an axial or longitudinal centerline C of the first screw2002. The second tower2014can removably couple with the second screw2004such that, when the second tower2014is coupled with the second screw2004, an axial centerline C of the distal portion2014aof the second tower2014is approximately collinear with an axial centerline C of the second screw2004. The third tower2016can removably couple with the third screw2006such that, when the third tower2016is coupled with the third screw2006, an axial centerline C of the distal portion2016aof the third tower2016is approximately collinear with an axial centerline C of the third screw2006. In any embodiments, the first tower2012can be shorter than the second tower2014or the third tower2016, longer than the second tower2014or the third tower2016, or have approximately the same length as the second tower2014or the third tower2016, and the second tower2014can be shorter than the third tower2016, longer than the third tower2016, or have approximately the same length as the third tower2016.

In some embodiments, the angle between the proximal portion2012band distal portion2012aof the first tower2012can be adjustable, an angle between the proximal portion2014band distal portion2014aof the second tower2014can be adjustable, and/or the angle between the proximal portion2016band distal portion2016aof the third tower2016can be adjustable. A common mechanism for adjustability is a gear or ratchet mechanism. In this way, the proximal portion of any of the extensions can be angled away from the centerline of the distal portion of the respective screw. By adjusting the angle, there may be more room to place the rod and locking caps. Also, by adjusting the angle, it may be easier for a surgeon to grip both proximal portions of the towers in order to squeeze the two or three proximal portions of the extensions in order to compress the heads of screws when locking the caps onto the connecting element or rod connecting the screw heads. In another embodiment, proximal portions2012b,2014b, and/or2016bcan be detachable from the distal portions2012a,2014a, and/or2016a. In this manner, proximal portions with different angles in relation to centerline of the respective distal portions can be switched as needed and reconnected to the distal portions of the extensions.

As mentioned, in some embodiments, the proximal portion2012bof the first tower2012can extend at an angle away from the axial centerline C of the distal portion2012aof the first tower2012such that an axial centerline of the proximal portion2012bof the first tower2012is not approximately collinear with an axial centerline of the distal portion2012aof the first tower2012. Further, the first tower2012can be configured such that, in an operable state, an axial centerline of the proximal portion2012bof the first tower2012can extend at an angle away from the axial centerline C of the proximal portion of the second tower2014so that the axial centerline of proximal portion2012bof the first tower2012forms an acute angle A1relative to the axial centerline of the proximal portion of the second tower2014, as shown inFIG.10B. In some embodiments, the angle A1can be 50° (or approximately 50°), or from 40° (or approximately 40°) or less to 70° (or approximately 70°) or more. The third tower2016can be configured such that, in an operable state, an axial centerline of the proximal portion2016bof the third tower2016can extend at an angle away from the axial centerline C of the proximal portion of the second tower2014so that the axial centerline of proximal portion2016bof the third tower2016forms an acute angle A2relative to the axial centerline of the proximal portion of the second tower2014in an operable state, as shown inFIG.10B. In some embodiments, the angle A2can be 50° (or approximately 50°), or from 40° (or approximately 40°) or less to 70° (or approximately 70°) or more.

In some embodiments, the first tower2012can be angled such that, in an operable state, the proximal portion2012bof the first tower2012can extend away from the proximal portion2014bof the second tower2014in a first direction, and the third tower2016can be angled such that, in an operable state, the proximal portion2016bof the third tower2016can also extend away from the proximal portion of the second tower2014in the same direction or approximately the same direction as the proximal portion2012bof the first tower—e.g., in the first direction. In some embodiments, the axial centerlines of the proximal portions2012b,2016bof the first and third towers2012,2016can be within the same plane (e.g., a first plane) when the proximal portions2012b,2016bof the first and third towers2012,2016extend away from the proximal portion of the second tower2014in the same direction. The first plane that contains the axial centerlines of the proximal portions2012b,2016bof the first and third towers2012,2016can also intersect with the axial centerline of the second tower2014, in some embodiments.

In some embodiments, the first tower2012can be sized and configured such that, in an operable state, the proximal portion2012bof the first tower2012can extend away from the skin incision S toward the surgeon. In some embodiments, the first, second, and third towers2012,2014, and2016can be sized and configured such that the level of the patient's skin in an operable state of the system2000will be at or adjacent to the bend2052(e.g., just below the bend2052) formed in the third tower2016. In some embodiments, the distal portion2012aof the first tower2012and the distal portion2016aof the third tower2016can extend away from the first screw2002and the third screw2006to a height just below the skin incision S, or to a height level with the skin of a patient, when the first and third screws2002,2006are fully implanted in a first vertebra and a third vertebra, respectively.

In some embodiments, the first tower2012can be sized such that only the proximal portion2012bof the first tower2012is outside of the skin incision S when the first screw2002is implanted in a first vertebra, and the third tower2016can be sized such that only the proximal portion2016bof the third tower2016is outside of the skin incision S when the third screw2006is implanted in a third vertebra. In any embodiments, the second tower2014can be sized to extend completely through the skin incision S when the second screw2004is implanted in a second vertebra.

The proximal portion2012bof the first tower2012and the proximal portion2016bof the third tower2016can be configured to be grasped by a surgeon to enable a surgeon to exert a rotational force on the first tower2012about at least the axial centerline C of the distal portion2012aof the first tower2012about at least the axial centerline C of the distal portion2012aof the first tower2012and/or a torque force on the first tower2012so as to cause the first tower2012to rotate about an axis that is perpendicular to an axial centerline C of the distal portion2012aof the first tower2012. The proximal portion2016bof the third tower2016and the proximal portion2016bof the third tower2016can be configured to be grasped by a surgeon to enable a surgeon to exert a rotational force on the third tower2016about at least the axial centerline C of the distal portion2016aof the third tower2016about at least the axial centerline C of the distal portion2016aof the third tower2016and/or a torque force on the third tower2016so as to cause the third tower2016to rotate about an axis that is perpendicular to an axial centerline C of the distal portion2016aof the third tower2016.

The proximal portion2012bof the first tower2012can have a length that is approximately the same as a length of the distal portion2012aof the first tower2012, or can have a length that is at least 80% or less of a length of the distal portion2012aof the first tower2012. In some embodiments, the proximal portion2012bof the first tower2012can be removably coupled with the distal portion2012aof the first tower2012. In other embodiments, the proximal portion2012bof the first tower2012can be non-removably coupled with the distal portion2012aof the first tower2012. For example and without limitation, the proximal portion2012bof the first tower2012can be integrally formed with the body portion of the first tower2012. In any embodiments, the second and third towers2014,2016can be similarly configured.

In some embodiments, at least the distal portion2012a, the proximal portion2012bof the first tower2012, and/or the second tower2014can have a tubular or half-tubular shape. The first tower2012can have a cutout2024formed through a wall portion2026of the first tower2012, the cutout2024being configured to receive a portion of an outside surface2014cof the second tower2014therein in an operable state, as shown in the figures. In some embodiments, the cutout2024of the first tower2012can be large enough to also receive a portion of an outside surface2016cof the third tower2016therein in an operable state, as shown in the figures. In some embodiments, the cutout2024can extend at least through a proximal end2012cof the distal portion2012aof the first tower2012. The cutout2024can extend entirely through the first tower2012and be sized and configured such that, in an operable state, the second tower2014and the screw coupled with the second tower2014can pass entirely through the cutout2024in the first tower2012and the screw coupled with the third tower2016and at least the distal portion2016bof the third tower2016can pass entirely through the cutout2024.

In some embodiments, the cutout2024can extend entirely through the first tower2012such that, in an operable state, the second tower2014can pass entirely through the cutout2024and such that the wall portion2026of the first tower2012completely and continuously surrounds the outside surface2014cof a portion of the second tower2014and the outside surface2016cof a portion of the third tower2016. Some embodiments of the cutout2024can have a distal edge2030. In some embodiments, the distal edge2030can be lower to allow for a wider range of rotation or movement of the first tower2012relative to the second tower2014. In some embodiments, the cutout2024can extend distally to be near to or adjacent to the distal end of the first tower. Some embodiments of the cutout2024can have an elongated or ovular shape.

In some embodiments, at least the distal portion2016aand the proximal portion2016bof the third tower2016can have a tubular or half-tubular shape. The third tower2016can have a cutout2044formed through a wall portion2046of the third tower2016, the cutout2044being configured to receive a portion of an outside surface2014cof the second tower2014therein in an operable state, as shown in the figures. In some embodiments, the cutout2044can extend at least through a proximal end2016cof the distal portion2016aof the third tower2016. The cutout2044can extend entirely through the third tower2016such that, in an operable state, the second tower2014and the screw coupled with the second tower2014can pass entirely through the cutout2044in the third tower2016.

In some embodiments, the cutout2044can be configured such that, in an operable state, the second tower2014can pass entirely through the cutout2044and such that the wall portion2046of the third tower2016completely and continuously surrounds the outside surface2014cof a portion of the second tower2014. Further, some embodiments of the cutout2044can have a distal edge2050. In some embodiments, the distal edge2050can be lower to allow for a wider range of rotation or movement of the third tower2016relative to the second tower2014. In some embodiments, the cutout2044can extend distally to be near to or adjacent to the distal end of the tower (e.g., the third tower2016). Some embodiments of the cutout2044can have an elongated or ovular shape.

In some embodiments, at least the distal portion2012aof the first tower2012, the distal portion2016aof the third tower2016, and/or the distal portion2014aof the second tower2014can have an adjustable length. Further, some embodiments of the first tower2012, the second tower2014, and the third tower2016can be generally cylindrically shaped. Other embodiments can have any other desired cross-sectional shape, including a generally square shape, a triangular cross-sectional shape, on ovular cross-sectional shape, a polygonal cross-sectional shape, or any combination of the foregoing.

The proximal portion2012bof the first tower2012and/or the proximal portion2016bof the third tower2016can have a cross-sectional profile that can have a curved shape. Further, the proximal portion2012bof the first tower2012and/or the proximal portion2016bof the third tower2016can have a cross-sectional profile that can have a semi-circular tubular shape. In some embodiments, the proximal portion2012bof the first tower2012and/or the proximal portion2016bof the third tower2016can have a cross-sectional profile that is approximately the same as one-half of the distal portion2012aof the first tower2012and one-half of the distal portion2016aof the third tower2016. In some embodiments, the proximal portion2012bof the first tower2012and/or the proximal portion2016bof the third tower2016can have a planar shape.

Any of the embodiments of the system2000disclosed herein can have a rigid connecting element (not shown), similar to any of the other embodiments of the connecting elements disclosed herein, that can be implanted using any desired shape and configuration of a connecting element implantation device, such as the embodiment of the connecting element implantation device shown inFIGS.3E-3F, or implanted using any other devices or methods disclosed herein or other desired devices or methods. A first receiving element coupled with the head of the first screw2002, a second receiving element coupled with the head of the second screw2004, and a third receiving element coupled with the head of the third screw2006can secure the connecting element to the screws2002,2004,2006. The first, second, and third receiving elements can be configured to operably receive the connecting element that, in an operable state, can extend between the first, second, and third receiving elements when the first screw2002, the second screw2004, and the third screw2006are implanted in a first vertebra, a second vertebra, and a third vertebra, respectively.

In some embodiments, the first tower2012can have at least one window or slot2062extending through a side of the body portion thereof, the at least one slot2062configured to receive a connecting element2051or configured to permit a passage of a connecting element2051therethrough. Further, the second tower2014can have at least one slot or window2064extending through a side of the body portion of the second tower2014, the at least one slot2064of the second tower2014configured to receive the connecting element2051that is configured to extend between the first screw2002and the third screw2006in an operable state. The third tower2016can have at least one slot or window2066extending through a side of the body portion of the third tower2016, the at least one slot2066of the third tower2016configured to receive the connecting element2051that is configured to extend between the first screw2002and the third screw2006in an operable state. Lengthwise slots or channels can be formed in at least the distal portions of each of the first, second, and third towers to permit the connecting element to pass distally toward the screws.

In some embodiments of the system2000, the first tower2012can have an insert or projection2070formed thereon or coupled therewith. The projection2070can have a distal portion2070athat, in some embodiments, in an operable state, contacts the outside surface2014cof the second tower2014to provide a point or a region of contact between the proximal portion2012aof the first tower2012and the proximal portion2014bof the second tower2014. In some embodiments of this configuration, as the proximal portion2012bof the first tower2012is squeezed relative to or otherwise rotated or moved toward the proximal portion2014bof the second tower2014, the distal portion2070aof the projection2070can contact the outside surface2014cof the second tower2014and the distal portion2012aof the first tower2012can be moved toward the distal portion2014aof the second tower2014to cause a compressive force to be exerted on a first vertebra that the first tower2012is coupled with relative to a second, adjacent vertebra that the second tower2014is coupled with. In other embodiments, the projection2070can be configured to rotate or otherwise move so that the point or region of contact and rotation between the first and second towers2012,2014is only at the distal end2030of the opening2024. In some embodiments of this configuration, as the proximal portion2012bof the first tower2012is moved away from the proximal portion2014bof the second tower2014, the distal portion2012aof the first tower2012can be moved away from the distal portion2014aof the second tower2014to cause a traction force to be exerted on a first vertebra that the first tower2012is coupled with relative to a second, adjacent vertebra that the second tower2014is coupled with.

In some embodiments, the insert2070can be removably inserted into an interior space of the proximal portion2012bof the first tower2012and positioned between the proximal portion2012bof the first tower2012and the proximal portion2016bof the third tower2016, when needed or desired, to provide a fulcrum between the first and third towers2012,2016during compression. In other embodiments, the insert2070can be nonremovably coupled with the proximal portion2012bof the first tower2012or integrally formed with the proximal portion2012bof the first tower2012, or nonremovably coupled with an outside surface of the proximal portion2016bof the third tower2016or integrally formed with the proximal portion2016bof the third tower2016so as to be between the proximal portion2016bof the third tower2016and the proximal portion2012bof the first tower2012.

In some embodiments, the projection2070can be configured to contact the outside surface2016cof the third tower2016, for example, in a proximal portion2016bof the third tower2016, to provide a point or a region of contact and rotation, or a fulcrum, between the proximal portion2012aof the first tower2012and the proximal portion2016bof the third tower2016. In some embodiments of this configuration, as the proximal portion2012bof the first tower2012is squeezed relative to or otherwise rotated or moved toward the proximal portion2016bof the third tower2016, a proximal portion2070bof the projection2070can contact the outside surface2016cof the proximal portion2016bof the third tower2016to provide the point or a region of contact and rotation, or a fulcrum, between the proximal portion2012aof the first tower2012and the proximal portion2016bof the third tower2016to cause a compressive force to be exerted on a first vertebra that the first tower2012is coupled with relative to a third vertebra that the third tower2016is coupled with. In other embodiments, one or more rings, shafts, pins, pegs, and/or other mechanical connectors can be used to create the point or region of rotation, or fulcrum, between the first, second, and/or third towers2012,2014,2016. For example and without limitation, with reference toFIG.10B, a peg or a pair of pegs or pins advanced into the opening2015passing through the second tower2014that extends radially outwardly away from the outside surface2014cof the second tower2014could be used to provide a pivot point or fulcrum between the first tower2012and the third tower2016. The peg(s) or pin(s) that can extend through the openings2015can be used in lieu of the projection2070to provide the fulcrum between the first and third towers2012,2016. In some embodiments of this configuration, as the proximal portion2012bof the first tower2012is moved away from the proximal portion2016bof the third tower2016, the system2000can be configured to cause the distal portion2012aof the first tower2012to move away from the distal portion2016aof the third tower2016to thereby cause a traction force to be exerted on a first vertebra that the first tower2012is coupled with relative to a third vertebra that the third tower2016is coupled with.

In some embodiments, the first, second, and third towers2012,2014,2016can be configured to be selectively removable from the first, second, and third screws2002,2004,2006. For example and without limitation, some embodiments of the first, second, and third towers2012,2014,2016can have one or more creases, fracture lines, or lines of weakness (for example, two creases, fracture lines, or lines of weakness) along a length of a wall portion of any or all of the first, second, and third towers2012,2014,2016. In some embodiments, a tool or other device can be used to fracture the first, second, and third towers2012,2014,2016along the one or more creases, fracture lines, or lines of weakness to remove the first, second, and third towers2012,2014,2016from the first, second, and third screws2002,2004,2006. In some embodiments, the one or more creases, fracture lines, or lines of weakness can be circumferentially arranged and positioned at or adjacent to a top surface of the screws that the towers are attached to so that the towers can break along the one or more creases, fracture lines, or lines of weakness at or adjacent to the screws and be removed.

In some embodiments, the first, second, and third towers2012,2014,2016can have distal end portions having circumferential, helical, and/or discrete/intermittent projections, tabs, lip(s), flanges, grooves, channels, detents, or other mechanically locking features that engage with complementary locking features of the screw heads to cause the first, second, and third towers2012,2014,2016to be coupled with the screw heads when the first, second, and third towers2012,2014,2016are intact, but which can each be decoupled from the complementary locking features of the screw heads when the first, second, and/or third towers2012,2014,2016are fractured or split apart. As another example, a third wall or connecting wall connecting two sides of any of the first, second, and/or third towers2012,2014,2016can have an angled or “V” shaped profile wherein a fracture line or line of weakness extends along the apex or angle of the angled or “V” shaped profile such that, when the two sides of the first, second, and third towers2012,2014,2016are squeezed toward one another, such force from the squeezing can cause a fracture along the fracture line or line of weakness in the connecting portion, thereby allowing the first and second sides of the tower to separate so that tower can be removed from the screw head. In some embodiments, a slider ring can be slid down the tower to cause the two sides of the tower to be squeezed toward one another. In some embodiments, the first, second, and third towers2012,2014,2016can have tabs that extend from the first, second, and third screw heads that can be broken off from the screw heads after implantation. In some embodiments, the first, second, and/or third towers can be removably coupled with the first, second, and/or third screws by rotating the first, second, and/or third towers into engagement with the first, second, and/or third screws, and removed in the opposite manner.

In other embodiments, the extensions can be removably coupled with the screws so that the entire extension can be removed from the screw and the patient intact and be reused in subsequent procedures. For example and without limitation, ball and detent removable coupling mechanisms can be used to removably couple the first, second, and third towers2012,2014,2016with the first, second, and third screw heads. Other conventional or desired coupling mechanisms can be used to removably couple the first, second, and third towers2012,2014,2016with the first, second, and third screw heads. In other embodiments, a plurality of wires (such as, for example and without limitation, wires140a,140bshown inFIG.1A) can be used to removably couple the first, second, and third towers2012,2014,2016with the first, second, and third screw heads, as described above with respect to the embodiments shown inFIGS.1A-1Z.

Some embodiments of methods for treating a spinal defect include implanting a first screw2002that is coupled with a first tower2012through the incision into a first vertebra, advancing a third tower2016that is coupled with a third screw2006through the cutout2024formed in the first tower2012and implanting the third screw2006into a third vertebra, and advancing a second tower2014that is coupled with a second screw2004through the cutout2044formed in the third tower2016and implanting the second screw2004into a second vertebra. In some embodiments, the second vertebra can be between the first and third vertebrae.

The surgeon or medical practitioner can move a proximal portion2012bof the first tower2012toward a proximal portion2016bof the third tower2016to cause the distal portion2012aof the first tower2012to move toward the distal portion2016aof the third tower2016, thereby causing a compressive force to be applied between the first, second, and third vertebrae. In some embodiments, the method can further include coupling a rigid connector or rod with the first screw2002, the second screw2004, and the third screw2006to generally fix a position of the first screw2002relative to the second screw2004and the third screw2006. Thereafter, the first, second, and third towers2012,2014,2016can be removed from the first, second, and third screws2002,2004,2006.

Any embodiments of the system2000disclosed herein can be configured for use in performing L4, L5 and S1 surgical procedures, as well as cortical screw trajectory procedures. Additionally, any embodiments of the system2000disclosed herein can be configured to enable compression, traction, and/or counter-torque all with one device, and the extensions can be configured to allow a tower, rod insertion, and rod reducer (using extended tabs with threads) with one device.

Certain aspects of the systems, devices, components and/or methods described above or as illustrated with respect toFIGS.10A-10Gare also encompassed by the following numbered embodiments. These numbered embodiments are considered to be directed to systems, devices, components and/or methods that include but are not limited to the embodiments ofFIGS.10A-10G, and thus these numbered embodiments may encompass other embodiments as described throughout this specification. Additionally, note that, while the embodiments of the system disclosed below may be described as including screws, any of the following embodiments may exclude any and all screws such that the embodiments only include the first tower, the second tower, and the third tower, plus any other components other than the screws (e.g., connecting element).1. A system for stabilizing spinal vertebrae through a skin incision, comprising:a first screw having a first screw head, a second screw having a second screw head, and a third screw having a third screw head;a first tower having a distal portion and a proximal portion, the first tower being configured to be removably coupled with the first screw at a distal end of the first tower;a second tower having a distal portion and a proximal portion, the second tower configured to be removably coupled with the second screw at a distal end of the second tower; anda third tower having a distal portion and a proximal portion, the third tower being configured to be removably coupled with the third screw at a distal end of the third tower;wherein:the first tower is configured to removably couple with the first screw such that, when the first tower is coupled with the first screw, an axial centerline of the distal portion of the first tower is approximately collinear with an axial centerline of the first screw;the second tower is configured to removably couple with the second screw such that, when the second tower is coupled with the second screw, an axial centerline of the distal portion of the second tower is approximately collinear with an axial centerline of the second screw;the third tower is configured to removably couple with the third screw such that, when the third tower is coupled with the third screw, an axial centerline of the distal portion of the third tower is approximately collinear with an axial centerline of the third screw;the proximal portion of the first tower extends at an acute, nonzero angle away from the axial centerline of the distal portion of the first tower; andthe proximal portion of the third tower extends at an acute, nonzero angle away from the axial centerline of the distal portion of the third tower.2. The system of Embodiment 1, wherein the proximal portion of the first tower is configured such that, in an operable state of the system, the proximal portion of the first tower also extends at an acute, nonzero angle away from the axial centerline of the proximal portion of the second tower so that the proximal portion of the first tower forms an acute angle relative to the proximal portion of the second tower.3. The system of any one of the previous Embodiments, wherein the first tower is sized and configured such that, in an operable state, the proximal portion of the first tower extends away from a skin incision toward a surgeon.4. The system of any one of the previous Embodiments, wherein the distal portion of the first tower extends away from the first screw to a height just below the skin incision, or to a height level with the skin of a patient, when the first screw is fully implanted in a first vertebra.5. The system of any one of the previous Embodiments, wherein the proximal portion of the first tower is configured to be grasped by a surgeon to enable a surgeon to exert a rotational force on the first tower about at least the axial centerline of the distal portion of the first tower and/or a torque force on the first tower so as to cause the first tower to rotate about an axis that is perpendicular to an axial centerline of the distal portion of the first tower.6. The system of any one of the previous Embodiments, wherein the proximal portion of the third tower is configured to be grasped by a surgeon to enable a surgeon to exert a rotational force on the third tower about at least the axial centerline of the distal portion of the third tower and/or a torque force on the third tower so as to create a compressive force on a third vertebra that the third screw is coupled with relative to a first vertebra that the first screw is coupled with.7. The system of any one of the previous Embodiments, wherein the first tower is sized such that only the proximal portion of the first tower is outside of a skin incision when the first screw is implanted in a first vertebra.8. The system of any one of the previous Embodiments, wherein the third tower is sized such that only the proximal portion of the third tower is outside of a skin incision when the third screw is implanted in a third vertebra.9. The system of any one of the previous Embodiments, wherein the second tower is sized to extend completely through a skin incision when the second screw is implanted in a second vertebra.10. The system of any one of the previous Embodiments, wherein the system is configured such that the first, second, and third screws are implanted through the same skin incision.11. The system of any one of the previous Embodiments, wherein the proximal portion of the first tower has a length that is approximately the same as a length of the distal portion of the first tower.12. The system of any one of the previous Embodiments, wherein the proximal portion of the first tower has a length that is at least 80% of a length of the distal portion of the first tower.13. The system of any one of the previous Embodiments, wherein the proximal portion of the first tower is removably coupled with the distal portion of the first tower and the proximal portion of the third tower is removably coupled with the distal portion of the third tower.14. The system of any one of the previous Embodiments, wherein the proximal portion of the first tower is non-removably coupled with the distal portion of the first tower and the proximal portion of the third tower is non-removably coupled with the distal portion of the third tower.15. The system of any one of the previous Embodiments, wherein the proximal portion of the first tower is integrally formed with the body portion of the first tower.16. The system of any one of the previous Embodiments, wherein at least the proximal portions of the first tower and the second towers have a tubular shape.17. The system of any one of the previous Embodiments, wherein the first tower has a cutout formed through a wall portion of the first tower, the cutout being configured to receive at least the second tower and the third tower therein in an operable state.18. The system of Embodiment 17, wherein the cutout extends at least through a proximal end of the distal portion of the first tower.19. The system of Embodiment 17, wherein the cutout extends entirely through the first tower such that, in an operable state, the second tower can pass entirely through the cutout.20. The system of Embodiment 17, wherein the cutout extends entirely through the first tower such that, in an operable state, the second tower can pass entirely through the cutout and such that the wall portion of the first tower surrounds an outside surface of a portion of the second tower.21. The system of any one of Embodiments 17-20, wherein the cutout is shaped such that a distal edge of the cutout is configured to contact an outside surface of the second tower in an operable state so that the second tower can be rotated about the distal edge of the cutout relative to the first tower.22. The system of any one of Embodiments 17-21, wherein the cutout has an ovular or elongated shape.23. The system of any one of Embodiments 17-22, wherein the cutout is adjacent to a proximal end of the distal portion of the first tower and a distal end of the proximal portion of the first tower.24. The system of any one of the previous Embodiments, wherein the third tower has a cutout formed through a wall portion of the third tower, the cutout being configured to allow the second tower to pass through the cutout of the third tower in an operable state.25. The system of Embodiment 24, wherein the cutout extends entirely through the third tower such that, in an operable state, the second tower can pass entirely through the cutout.26. The system of any one of Embodiments 24-25, wherein the cutout has an ovular or elongated shape.27. The system of any one of Embodiments 24-22, wherein the cutout is adjacent to a proximal end of the distal portion of the third tower and a distal end of the proximal portion of the third tower.28. The system of any one of the previous Embodiments, wherein the proximal portion of the first tower and/or the third tower is open along one side thereof and not fully enclosed.29. The system of any one of the previous Embodiments, wherein, in an operable state, an axial centerline of both the distal portion of the third tower and the proximal portion of the third tower extend at a nonzero angle away from the axial centerline of the second tower in a same direction.30. The system of any one of the previous Embodiments, wherein, in an operable state, an axial centerline of both the proximal portion of the first tower and the proximal portion of the third tower extend at a nonzero angle away from the axial centerline of the second tower in a same direction.31. The system of any one of the previous Embodiments, wherein at least the distal portion of the first tower and the distal portion of the third tower have an adjustable length.32. The system of any one of the previous Embodiments, wherein at least the distal portion of the first tower, the distal portion of the second tower, and the distal portion of the third tower are generally cylindrically shaped.33. The system of any one of the previous Embodiments, wherein the proximal portion of the first tower and the proximal portion of the third tower have a cross-sectional profile having a curved shape.34. The system of any one of the previous Embodiments, wherein the proximal portion of the first tower and the proximal portion of the third tower have a cross-sectional profile having a semi-circular tubular shape.35. The system of any one of the previous Embodiments, wherein the proximal portion of the first tower and the proximal portion of the third tower have a planar shape.36. The system of any one of the previous Embodiments, further comprising: a rigid connecting element; a first receiving element coupled with the first screw head; a second receiving element coupled with the second screw head; and a third receiving element coupled with the third screw head; wherein the first, second, and third receiving elements are configured to operably receive the connecting element that, in an operable state, extends between the first, second, and third receiving elements when the first, second, and third screws are implanted in a first, second, and third vertebra, respectively.37. The system of any one of the previous Embodiments, wherein the first tower has at least one window extending through a side of the body portion thereof, the at least one window configured to receive a connecting element that is configured to extend between the first, second, and third screws in an operable state.38. The system of any one of the previous Embodiments, wherein the second tower has at least one window extending through a side of the body portion thereof, the at least one window of the second tower configured to receive a connecting element that is configured to extend between the first, second, and third screws in an operable state.39. The system of any one of the previous Embodiments, wherein the third tower has at least one window extending through a side of the body portion thereof, the at least one window of the third tower configured to receive a connecting element that is configured to extend between the first, second, and third screws in an operable state.40. The system of any one of the previous Embodiments, wherein the first tower is shorter than the second tower at least in an operable state.41. The system of any one of the previous Embodiments, wherein the first tower has a projection which provides a fulcrum for rotation of the first tower relative to the third tower.42. The system of any one of the previous Embodiments, wherein the first, second, and third towers are releasably mechanically coupled with the first, second, and third screws, respectively.43. The system of any one of the previous Embodiments, comprising two or more of the first towers and/or two or more of the third towers, wherein each of the two or more of the first towers define a different angle between the proximal portion and the distal portion of the first towers and each of the two or more of the third towers define a different angle between the proximal portion and the distal portion of the third towers.44. A method of stabilizing spinal vertebrae, comprising:implanting a first screw that is coupled with a first tower through an incision into a first vertebra;advancing a third tower that is coupled with a third screw through a cutout formed in the first tower and implanting the third screw into a third vertebra;advancing a second tower that is coupled with a second screw through a cutout formed in the third tower and implanting the second screw into a second vertebra; andmoving a proximal portion of the first tower toward a proximal portion of the third tower to cause a compressive force on at least the third vertebra relative to the first vertebra.45. The method of Embodiment 42, further comprising coupling a rigid connector with the first screw, the second screw, and the third screw to generally fix a position of the first screw relative to the second screw and the third screw.
Systems, Devices and Methods ofFIGS.11A-11G

Additional embodiments of a system2200that can be used for stabilizing or treating spinal vertebrae through a skin incision S are disclosed below. In any embodiments disclosed herein, any components, features, or other details of the system2200can have any of the components, features, or other details of any other system embodiments disclosed herein or be used according to any of the steps of any other method embodiments disclosed herein, including without limitation any of the embodiments of the system200,300,400, and/or2000or methods of use thereof described herein, in any combination with any of the components, features, or details of the system2200or methods of use disclosed herein. Similarly, any components, features, steps, or other details of any of the other system or method embodiments disclosed herein can have any of the components, features, steps, or other details of any embodiments of the system2200or methods of use thereof disclosed herein in any combination with any of the components, features, or details of the system.

Some embodiments of the system2200can be configured and/or optimized for use in robotic surgical procedures. For example and without limitation, in some embodiments, the proximal portions of the towers can be configured and optimized for grasping and locating by end effectors or robotic arms of a surgical robot. An advantage of some embodiments of the system2200and other systems disclosed herein as compared to conventional spinal surgical systems is that two or more, or three or more towers of some embodiments of the system2200can be advanced and manipulated through a single incision in the patient's back. Another advantage of some embodiments of the system2200and other systems disclosed herein as compared to conventional spinal surgical systems is that the two or more or three or more towers of some embodiments of the system can be constrained by each other or otherwise configured to limit a range of movement of the towers relative to one another. This can assist in the ability to locate and/or control the towers of the system, particularly by a surgical robot. This can also make it easier to advance the connecting element (also referred to herein as a connecting rod) through the two or more towers or three or more towers because the two or more towers will be better aligned.

Some embodiments of the system2200can be configured such that any of the towers attached to screws can be placed robotically and allow rod placement, rod reduction, compression, and/or final tightening with counter-torque all to be performed robotically through a mechanical coupling of parts of the tower system with robotic arms. The robot, navigation system, and/or software can be configured to identify or determine the positions of all towers screws, rods and caps at any desired time. In some embodiments, the proximal portions of the towers of any embodiments disclosed herein can be configured to be compatible with graspers, coupling mechanisms, and/or end effectors of surgical robots. For example and without limitation, as disclosed herein, the proximal portions of some embodiments of the towers disclosed herein can have a flat profile that can more easily and controllably be grasped by graspers, coupling mechanisms, and/or end effectors of surgical robots.

In any embodiments, the first, second, and third towers coupled with the screws can extend outside the body through the incision, and the proximal ends thereof can provide “handles” to allow the surgeon to know the position and orientation of the three screw heads constantly. This arrangement can also permit a robotic system to determine the orientation and position of all screw heads so that a robotic system would be able to lower the rod or connecting element directly into the screw heads, including with rotating the connecting element from vertical to horizontal into the seat of the heads of the screws. Any of the towers or other components can have additional features added thereto or otherwise be configured to integrate into a robotic system. Thereafter, the towers can be removed and withdrawn from the body, manually or robotically.

Some embodiments of the system2200for stabilizing spinal vertebrae through a skin incision S can include a first screw2202, a second screw2204, a third screw2206, a first tower2212having a distal portion2212aand a proximal portion2212b, a second tower2214having a distal portion2214aand a proximal portion2214b, and a third tower2216having a distal portion2216aand a proximal portion2216b. The first tower, second tower, and third tower can also be referred to herein as a first extension, second extension, and third extension, or guiding elements, or by other suitable terms understood in the industry. The first tower2212can be configured to be removably coupled with the first screw2202at a distal end2212aof the first tower2212, the second tower2214can be configured to be removably coupled with the second screw2204at a distal end2214aof the second tower2214, and third tower2216can be configured to be removably coupled with the third screw2206at a distal end2216aof the third tower2216. In some embodiments, each of the first, second, and third screws2202,2204,2206can be positioned in different vertebra. In some embodiments, each of the first, second, and third screws2202,2204,2206can be positioned in adjacent vertebra. Additionally, note that, while the embodiments of the system2200disclosed herein may have included screws as part of the system, any embodiments of the system2200disclosed herein can exclude the screws such that the embodiments of the system2200include the towers and/or other components other than the screws.

In any of the embodiments disclosed herein, the first, second, and third towers can be configured to be removably coupled with the screw heads and otherwise configured to be reuseable. This can save a significant cost as compared with disposable blade designs that, once the blade has been separated from the screw head, is typically discarded and not reused. From a surgical perspective, towers are more firm an rigid and can be used to provide rigidity to as to provide counter-torque during final tightening of the locking cap onto the rod in the screw head. Extended blades usually do not have the same strength as a counter-torque device. The towers of any of the embodiments disclosed herein, with the rigidity that they provide, can therefore help prevent the walls of the pedicle screw from splaying during final tightening of the locking cap.

The towers of some embodiments disclosed herein can provide a more complete enclosure than the blades or tabs can, due to the additional wall portions of the towers that extend between the sides of the towers. In some embodiments, as shown in the figures, the wall portions that extend between the two side wall portions to provide additional strength and stiffness can be integrally formed with the side wall portions, or can be separately formed and coupled (removably or nonremovably) with the side wall portions to provide additional rigidity to the towers.

In some embodiments, at least a portion of the distal portions of any embodiments of the first and/or third towers2212,2216can be enclosed about at least 320° (or at least approximately 320°) of the circumference or cross-section of the first and/or third towers2212,2216, or from 180° (or approximately 180° or less) to 330° (or approximately 330°, or at least 330°), or from 210° (or approximately 210°) to 320° (or approximately 320°), or enclosed about any value or range of value within the foregoing ranges. In some embodiments, at least a portion of the distal portions of any embodiments of the first and/or third towers2212,2216can be can be completely enclosed, with the optional exception of the channel extending lengthwise along at least the distal portion of the first and/or third towers2212,2216sized and configured to permit a passage of the rod or connecting element toward the screws. Additionally, for example and without limitation, at least a portion of the distal portion of any embodiments of the second tower2214can be enclosed about at least 270° (or at least approximately 270°) of the circumference or cross-section of the second tower2214, or from 240° (or approximately 240°) to 320° (or approximately 320°), or from 270° (or approximately 270°) to 300° (or approximately 300°), or enclosed about any value or range of value within the foregoing ranges. In some embodiments, at least a portion of the distal portion of any embodiments of the second tower2214can be can be completely enclosed, with the exception of a channel on each side of the distal portion2214bof the second tower2214extending lengthwise along at least the distal portion of the second tower2214sized and configured to permit a passage of the rod or connecting element toward the screws.

In some embodiments, at least a portion of the distal portions of any embodiments of the first and/or third towers2212,2216can be enclosed about at least 80% (or at least approximately 80%) of the circumference or cross-section of the first and/or third towers2212,2216, or from 70% (or approximately 70%) to 90% (or approximately 90%, or more than 90%—e.g., 95% or 100%), or from 75% (or approximately 75%) to 85% (or approximately 85%), or enclosed about any value or range of value within the foregoing ranges. Additionally, for example and without limitation, at least a portion of the distal portion of any embodiments of the second tower2214can be enclosed about at least 50% (or at least approximately 50%) of the circumference or cross-section of the second tower2214, or from 60% (or approximately 60%) to 80% (or approximately 80%), or from 65% (or approximately 65%) to 75% (or approximately 75%), or enclosed about any value or range of value within the foregoing ranges.

In some embodiments, with reference toFIG.11B, the first tower2212can have a bend between the distal portion2212aand the proximal portion2212bthereof. For example and without limitation, the distal portion2212acan be angled relative to the proximal portion2212bso that a longitudinal centerline C of the proximal portion2212bhas an angle that is 45° or approximately 45° relative to a longitudinal centerline C of the distal portion2212aof the first tower2212, or so that the longitudinal centerline of the proximal portion2212bhas an angle that is from 30° or approximately 30° to 60° or approximately 60°, or from 40° or approximately 40° to 50° or approximately 50° relative to the longitudinal centerline of the distal portion2212aof the first tower, or of any value or range of values within any of the foregoing ranges. In any embodiments, the second tower2214can be generally straight along a length thereof, as shown, or can have a bend between the distal portion2214aand the proximal portion2214bthereof within any of the ranges mentioned above for the first tower2212.

In some embodiments, the third tower2216can have a bend between the distal portion2216aand the proximal portion2216bthereof. The bend in the third tower2216can be less than, can be greater than, or can be the same as the bend in the first tower2212. For example and without limitation, the distal portion2216acan be angled relative to the proximal portion2216bso that a longitudinal centerline C of the proximal portion2216bhas an angle that is 45° or approximately 45° relative to a longitudinal centerline C of the distal portion2216aof the third tower2216, or that is 50° or approximately 50° relative to a longitudinal centerline C of the distal portion2216aof the third tower2216, or so that the longitudinal centerline C of the proximal portion2216bhas an angle that is from 30° or approximately 30° to 60° or approximately 60°, or from 40° or approximately 40° to 50° or approximately 50° relative to the longitudinal centerline of the distal portion2216aof the first tower2212, or of any value or range of values within any of the foregoing ranges.

Any embodiments of the system2200disclosed herein can be configured such that the first screw2202, the second screw2204, and the third screw2206can be implanted through the same skin incision S. Further, in any embodiments, a distal portion2214aof the second tower2214can be positioned between the distal portions2212a,2216aof the first and third towers2212,2216in an operable state of the system2200.

In some embodiments, the first tower2212can have a two or more proximal portions2212bextending away from the distal portion2212aof the first tower2212at a variety of angles. For example and without limitation, the two or more proximal portions2212bextending away from the distal portion2212aof the first tower2212can provide two or more separate handles extending away from the distal portion2212athat a surgeon can grasp and manipulate. In some embodiments, the first tower2212can removably couple with the first screw2202such that, when the first tower2212is coupled with the first screw2202, an axial or longitudinal centerline C of the distal portion2212aof the first tower2212is approximately collinear with an axial or longitudinal centerline C of the first screw2202. The second tower2214can removably couple with the second screw2204such that, when the second tower2214is coupled with the second screw2204, an axial centerline C of the distal portion2214aof the second tower2214is approximately collinear with an axial centerline C of the second screw2204. The third tower2216can removably couple with the third screw2206such that, when the third tower2216is coupled with the third screw2206, an axial centerline C of the distal portion2216aof the third tower2216is approximately collinear with an axial centerline C of the third screw2206. In any embodiments, the first tower2212can be shorter than the second tower2214or the third tower2216, longer than the second tower2214or the third tower2216, or have approximately the same length as the second tower2214or the third tower2216, and the second tower2214can be shorter than the third tower2216, longer than the third tower2216, or have approximately the same length as the third tower2216.

In some embodiments, the angle between the proximal portion2212band distal portion2212aof the first tower2212can be adjustable, an angle between the proximal portion2214band distal portion2214aof the second tower2214can be adjustable, and/or the angle between the proximal portion2216band distal portion2216aof the third tower2216can be adjustable. A common mechanism for adjustability is a gear or ratchet mechanism. In this way, the proximal portion of any of the extensions can be angled away from the centerline of the distal portion of the respective screw. By adjusting the angle, there may be more room to place the rod and locking caps. Also, by adjusting the angle, it may be easier for a surgeon to grip both proximal portions of the towers in order to squeeze the two or three proximal portions of the extensions in order to compress the heads of screws when locking the caps onto the connecting element or rod connecting the screw heads. In another embodiment, proximal portions2212b,2214b, and/or2216bcan be detachable from the distal portions2212a,2214a, and/or2216a. In this manner, proximal portions with different angles in relation to centerline of the respective distal portions can be switched as needed and reconnected to the distal portions of the extensions.

As mentioned, in some embodiments, the proximal portion2212bof the first tower2212can extend at an angle away from the axial centerline C of the distal portion2212aof the first tower2212such that an axial centerline of the proximal portion2212bof the first tower2212is not approximately collinear with an axial centerline of the distal portion2212aof the first tower2212. Further, the first tower2212can be configured such that, in an operable state, an axial centerline of the proximal portion2212bof the first tower2212can extend at an angle away from the axial centerline C of the proximal portion of the second tower2214so that the axial centerline of proximal portion2212bof the first tower2212forms an acute angle A1relative to the axial centerline of the proximal portion of the second tower2214, as shown inFIG.11B. In some embodiments, the angle A1can be 60° (or approximately 60°), or from 40° (or approximately 40°) or less to 80° (or approximately 80°) or more, or of any value or range of values within any of the foregoing ranges. The third tower2216can be configured such that, in an operable state, an axial centerline of the proximal portion2216bof the third tower2216can extend at an angle away from the axial centerline C of the proximal portion of the second tower2214so that the axial centerline of proximal portion2216bof the third tower2216forms an acute angle A2relative to the axial centerline of the proximal portion of the second tower2214in an operable state, as shown inFIG.11B. In some embodiments, the angle A2can be 30° (or approximately 30°), or from 15° (or approximately 15°) or less to 45° (or approximately 45°) or more.

In some embodiments, the first tower2212can be angled such that, in an operable state, the proximal portion2212bof the first tower2212can extend away from the proximal portion2214bof the second tower2214in a first direction, and the third tower2216can be angled such that, in an operable state, the proximal portion2216bof the third tower2216can also extend away from the proximal portion of the second tower2214in the same direction or approximately the same direction as the proximal portion2212bof the first tower—e.g., in the first direction. In some embodiments, the axial centerlines of the proximal portions2212b,2216bof the first and third towers2212,2216can be within the same plane (e.g., a first plane) or approximately the same plane when the proximal portions2212b,2216bof the first and third towers2212,2216extend away from the proximal portion of the second tower2214in the same direction. The first plane that contains the axial centerlines of the proximal portions2212b,2216bof the first and third towers2212,2216can also intersect with the axial centerline of the second tower2214, in some embodiments.

In some embodiments, the first tower2212can be sized and configured such that, in an operable state, the proximal portion2212bof the first tower2212can extend away from the skin incision S toward the surgeon. In some embodiments, the first, second, and third towers2212,2214, and2216can be sized and configured such that the level of the patient's skin in an operable state of the system2200will be at or adjacent to the bend2252(e.g., just below the bend2252) formed in the third tower2216or at or adjacent to the bend2253(e.g., just below the bend2253) formed in the first tower2212. In some embodiments, the distal portion2212aof the first tower2212and/or the distal portion2216aof the third tower2216can extend away from the first screw2202and the third screw2206to a height just below the skin incision S (for example and without limitation, wherein a distance from the skin surface to the proximal most end of the distal portion of the first or third tower is less than or equal to 10% or approximately 10%, is less than or equal to 15% or approximately 15%, or is less than or equal to 20% or approximately 20% of a length of the distal portion of the first or third tower), or to a height level with the skin of a patient, or to a height just above the skin incision S (for example and without limitation, wherein a distance from the skin surface to the proximal most end of the distal portion of the first or third tower is less than or equal to 10% or approximately 10%, is less than or equal to 15% or approximately 15%, or is less than or equal to 20% or approximately 20%, of a length of the distal portion of the first or third tower), when the first and third screws2202,2206are fully implanted in a first vertebra and a third vertebra, respectively.

In some embodiments, the first tower2212, the second tower2214, and/or the third tower2216can intersect at a height just below the skin incision S. For example and without limitation, the first tower2212, the second tower2214, and/or the third tower2216can intersect at an intersection point or points such that a distance from the skin surface to the point of intersection of the first tower2212and the second tower2214, the first tower2212and the third tower2216, the second tower2214and the third tower2216, and/or the first tower2212, the second tower2214, and the third tower2216is less than or equal to 10% of the length of the distal portion of the first tower or the third tower, wherein the point of intersection is at the skin surface, or optionally below the skin surface, or optionally above the skin surface for the intersection of the first tower2212and the second tower2214, the first tower2212and the third tower2216, the second tower2214and the third tower2216, and/or the first tower2212, the second tower2214, and the third tower2216.

In some embodiments, the first tower2212can be sized such that only the proximal portion2212bof the first tower2212is outside of the skin incision S when the first screw2202is implanted in a first vertebra, and the third tower2216can be sized such that only the proximal portion2216bof the third tower2216is outside of the skin incision S when the third screw2206is implanted in a third vertebra. In any embodiments, the second tower2214can be sized to extend completely through the skin incision S when the second screw2204is implanted in a second vertebra.

The proximal portion2212bof the first tower2212and the proximal portion2216bof the third tower2216can be configured to be grasped by a surgeon to enable a surgeon to exert a rotational force on the first tower2212about at least the axial centerline C of the distal portion2212aof the first tower2212about at least the axial centerline C of the distal portion2212aof the first tower2212and/or a torque force on the first tower2212so as to cause the first tower2212to rotate about an axis that is perpendicular to an axial centerline C of the distal portion2212aof the first tower2212. The proximal portion2216bof the third tower2216and the proximal portion2216bof the third tower2216can be configured to be grasped by a surgeon to enable a surgeon to exert a rotational force on the third tower2216about at least the axial centerline C of the distal portion2216aof the third tower2216about at least the axial centerline C of the distal portion2216aof the third tower2216and/or a torque force on the third tower2216so as to cause the third tower2216to rotate about an axis that is perpendicular to an axial centerline C of the distal portion2216aof the third tower2216.

The proximal portion2212bof the first tower2212can have a length that is approximately the same as a length of the distal portion2212aof the first tower2212, or can have a length that is at least 80% or less or 120% or less of a length of the distal portion2212aof the first tower2212. In some embodiments, the proximal portion2212bof the first tower2212can be removably coupled with the distal portion2212aof the first tower2212. In other embodiments, the proximal portion2212bof the first tower2212can be non-removably coupled with the distal portion2212aof the first tower2212. For example and without limitation, the proximal portion2212bof the first tower2212can be integrally formed with the body portion of the first tower2212. In any embodiments, the second and third towers2214,2216can be similarly configured.

In some embodiments, at least the proximal portion2212bof the first tower2212and/or the third tower2216can have a flat or rectangular shape—for example and without limitation, a solid rectangular shape wherein a width of the proximal portion can be significantly greater than a thickness of the proximal portion. In some embodiments, the width of the proximal portion of the first and/or third towers can be 6 times or approximately 6 times greater or more than a thickness of the proximal portion, or from 4 times or approximately 4 times greater to 8 times or approximately 8 times greater than a thickness of the proximal portion of the first and/or third towers, or of any values or from and to any values within the foregoing range. The first tower2212can have a cutout2224formed through a wall portion2226of the distal portion2212afirst tower2212and through the proximal portion2212bof the first tower2212. The cutout2224being configured to receive a portion of or permit the passage therethrough of an outside surface2214cof the second tower2214therein in an operable state, as shown in the figures. In some embodiments, the cutout2224of the first tower2212can be large enough to also receive a portion of an outside surface2216cof the third tower2216therein in an operable state, as shown in the figures. In some embodiments, the cutout2224can extend at least through a proximal end2212cof the distal portion2212aof the first tower2212. The cutout2224can extend entirely through the first tower2212and be sized and configured such that, in an operable state, the second tower2214and the screw coupled with the second tower2214can pass entirely through the cutout2224in the first tower2212and the screw coupled with the third tower2216and at least the distal portion2216bof the third tower2216can pass entirely through the cutout2224.

In some embodiments, the proximal portion2212bof the first tower2212can have an angled portion2213at a proximal most end of the proximal portion2212b. The angled portion can be angled relative to the adjacent portion of the proximal portion2212b. The angled portion can be angled at an angle of 45° or approximately 45° relative to the adjacent portion of the proximal portion2212b, or from 35° or approximately 35° to 55° or approximately 55° relative to the adjacent portion of the proximal portion2212b. The angled portion2213can have a slot2215formed therein. In some embodiments, the proximal portion2212bof the first tower2212can have a cross-sectional shape, profile, and/or size that is the same as or similar to handle portion of METRX RETRACTOR TUBES. The third tower2216can be similarly configured.

In some embodiments, the cutout2224can extend entirely through the first tower2212such that, in an operable state, the second tower2214can pass entirely through the cutout2224and such that the wall portion2226of the first tower2212completely and continuously surrounds the outside surface2214cof a portion of the second tower2214and the outside surface2216cof a portion of the third tower2216. Some embodiments of the cutout2224can have a distal edge2230. In some embodiments, the distal edge2230can be lower to allow for a wider range of rotation or movement of the first tower2212relative to the second tower2214. In some embodiments, the cutout2224can extend distally to be near to or adjacent to the distal end of the first tower. Some embodiments of the cutout2224can have an elongated or ovular shape.

In some embodiments, at least the distal portion2216aof the third tower2216can have a tubular or half-tubular shape. The third tower2216can have a cutout2244formed through a wall portion2246of the distal portion2216aof the third tower2216and through the proximal portion2216bof the third tower2216, the cutout2244being configured to receive a portion of an outside surface2214cof the second tower2214therein and/or to permit a user to advance the second tower2214therethrough in an operable state, as shown in the figures. In some embodiments, the cutout2244can extend at least through a proximal end2216cof the distal portion2216aof the third tower2216. The cutout2244can extend entirely through the third tower2216such that, in an operable state, the second tower2214and the screw coupled with the second tower2214can pass entirely through the cutout2244in the third tower2216.

In some embodiments, the cutout2244can be configured such that, in an operable state, the second tower2214can pass entirely through the cutout2244and such that the wall portion2246of the third tower2216completely and continuously surrounds the outside surface2214cof a portion of the second tower2214. In some embodiments, a shown, the cutout2244can be configured such that, in an operable state, the outside surface2214cof the second tower2214is only partially surrounded by the wall portion2246of the third tower2216. For example and without limitation, the third tower2216can form an approximately U shape at the proximal end2216cof the distal portion2216aof the third tower2216. Further, some embodiments of the cutout2244can have a distal edge2250. In some embodiments, the distal edge2250can be lower to allow for a wider range of rotation or movement of the third tower2216relative to the second tower2214. In some embodiments, the cutout2244can extend distally to be near to or adjacent to the distal end of the tower (e.g., the third tower2216). Some embodiments of the cutout2244can have an elongated or ovular shape.

In some embodiments, at least the distal portion2212aof the first tower2212, the distal portion2216aof the third tower2216, and/or the distal portion2214aof the second tower2214can have an adjustable length. Further, some embodiments of the distal portion of the first tower2212, the second tower2214, and/or the third tower2216can be generally cylindrically shaped. Other embodiments can have any other desired cross-sectional shape, including a generally square shape, a triangular cross-sectional shape, on ovular cross-sectional shape, a polygonal cross-sectional shape, or any combination of the foregoing.

The proximal portion2212bof the first tower2212and/or the proximal portion2216bof the third tower2216can have a cross-sectional profile that can have a curved shape. In some embodiments, the proximal portion2212bof the first tower2212and/or the proximal portion2216bof the third tower2216can have a planar shape.

Any of the embodiments of the system2200disclosed herein can include a rigid connecting element (not shown), similar to any of the other embodiments of the connecting elements disclosed herein, that can be implanted using any desired shape and configuration of a connecting element implantation device, such as the embodiment of the connecting element implantation device shown inFIGS.3E-3F, or implanted using any other devices or methods disclosed herein or other desired devices or methods. For example and without limitation, any embodiments of the system disclosed herein (including embodiments of the system2200) can be configured to implant the connecting element using the same or similar components of the MEDTRONIC SEXTANT II PERCUTANEOUS ROD SYSTEM, adapted for use with the embodiments disclosed herein. Any embodiments of the system disclosed herein (including embodiments of the system2200) can be configured to implant the connecting element using a rotating implantation component that is configured to rotate about an axis outside of the body and to deliver the connection element in the desired location with respect to the towers and screws.

In some embodiments, a first receiving element coupled with the head of the first screw2202, a second receiving element coupled with the head of the second screw2204, and a third receiving element coupled with the head of the third screw2206can secure the connecting element to the screws2202,2204,2206. The first, second, and third receiving elements can be configured to operably receive the connecting element that, in an operable state, can extend between the first, second, and third receiving elements when the first screw2202, the second screw2204, and the third screw2206are implanted in a first vertebra, a second vertebra, and a third vertebra, respectively.

In some embodiments, the first tower2212can have at least one window or slot2262extending through a side of the body portion thereof, the at least one slot2262configured to receive a connecting element2250or configured to permit a passage of a connecting element2250therethrough. Further, the second tower2214can have at least one slot or window2264extending through a side of the body portion of the second tower2214, the at least one slot2264of the second tower2214configured to receive the connecting element2250that is configured to extend between the first screw2202and the third screw2206in an operable state. The third tower2216can have at least one slot or window2266extending through a side of the body portion of the third tower2216, the at least one slot2266of the third tower2216configured to receive the connecting element2250that is configured to extend between the first screw2202and the third screw2206in an operable state. Lengthwise slots or channels can be formed in at least the distal portions of each of the first, second, and third towers to permit the connecting element to pass distally toward the screws.

In some embodiments of the system2200, though not shown, the first tower2212can optionally have an insert or projection2270formed thereon or coupled therewith or positioned adjacent thereto. The projection2270can have a distal portion2270athat, in some embodiments, in an operable state, contacts the outside surface2214cof the second tower2214to provide a point or a region of contact between the proximal portion2212aof the first tower2212and the proximal portion2214bof the second tower2214. In some embodiments of this configuration, as the proximal portion2212bof the first tower2212is squeezed relative to or otherwise rotated or moved toward the proximal portion2214bof the second tower2214, the distal portion2270aof the projection2270can contact the outside surface2214cof the second tower2214and the distal portion2212aof the first tower2212can be moved toward the distal portion2214aof the second tower2214to cause a compressive force to be exerted on a first vertebra that the first tower2212is coupled with relative to a second, adjacent vertebra that the second tower2214is coupled with. In other embodiments, the projection2270can be configured to rotate or otherwise move so that the point or region of contact and rotation between the first and second towers2212,2214is only at the distal end2230of the opening2224. In some embodiments of this configuration, as the proximal portion2212bof the first tower2212is moved away from the proximal portion2214bof the second tower2214, the distal portion2212aof the first tower2212can be moved away from the distal portion2214aof the second tower2214to cause a traction force to be exerted on a first vertebra that the first tower2212is coupled with relative to a second, adjacent vertebra that the second tower2214is coupled with.

In some embodiments, the insert2270can be removably or nonremovably positioned between the proximal portion2212bof the first tower2212and the proximal portion2216bof the third tower2216, when needed or desired, to provide a fulcrum between the first and third towers2212,2216during compression. In other embodiments, the insert2270can be nonremovably coupled with the proximal portion2212bof the first tower2212or integrally formed with the proximal portion2212bof the first tower2212, or nonremovably coupled with an outside surface of the proximal portion2216bof the third tower2216or integrally formed with the proximal portion2216bof the third tower2216so as to be between the proximal portion2216bof the third tower2216and the proximal portion2212bof the first tower2212.

In some embodiments, the projection2270can be configured to contact the outside surface2216cof the third tower2216, for example, in a proximal portion2216bof the third tower2216, to provide a point or a region of contact and rotation, or a fulcrum, between the proximal portion2212aof the first tower2212and the proximal portion2216bof the third tower2216. In some embodiments of this configuration, as the proximal portion2212bof the first tower2212is squeezed relative to or otherwise rotated or moved toward the proximal portion2216bof the third tower2216, a proximal portion2270bof the projection2270can contact the outside surface2216cof the proximal portion2216bof the third tower2216to provide the point or a region of contact and rotation, or a fulcrum, between the proximal portion2212aof the first tower2212and the proximal portion2216bof the third tower2216to cause a compressive force to be exerted on a first vertebra that the first tower2212is coupled with relative to a third vertebra that the third tower2216is coupled with. In other embodiments, one or more rings, shafts, pins, pegs, and/or other mechanical connectors can be used to create the point or region of rotation, or fulcrum, between the first, second, and/or third towers2212,2214,2216. For example and without limitation, with reference toFIG.11B, a peg or a pair of pegs or pins advanced into the opening2215passing through the second tower2214that extends radially outwardly away from the outside surface2214cof the second tower2214could be used to provide a pivot point or fulcrum between the first tower2212and the third tower2216. The peg(s) or pin(s) that can extend through the openings2215can be used in lieu of the projection2270to provide the fulcrum between the first and third towers2212,2216. In some embodiments of this configuration, as the proximal portion2212bof the first tower2212is moved away from the proximal portion2216bof the third tower2216, the system2200can be configured to cause the distal portion2212aof the first tower2212to move away from the distal portion2216aof the third tower2216to thereby cause a traction force to be exerted on a first vertebra that the first tower2212is coupled with relative to a third vertebra that the third tower2216is coupled with.

In some embodiments, the third tower2216can have one or more hooks2272(two being included in the illustrated embodiment) positioned at the sides of the proximal portion of the third tower2216. The hooks2272can extend laterally away from the sides of the proximal portion of the third tower2216. In some embodiments, the hooks2272can be used to constrain one or more wires (such as, without limitation, wires140a,140b) during a procedure. The hooks2272can also be used to create a pivot point or fulcrum against which a top surface of the proximal portion2212bof the first tower2212can contact and about which the first tower2212can pivot or rotate.

Additionally, the first tower2212can have a reinforcing element2274at or adjacent to a proximal end of the distal portion2212aof the first tower2212. The reinforcing element2274can extend laterally across the first tower2212and can increase the stiffness of the first tower2212in bending and/or in torsion. Similarly, in some embodiments, the third tower2216can have a reinforcing element2273at or adjacent to a proximal end of the distal portion2216aof the third tower2216. The reinforcing element2273of the third tower2216can extend laterally across the third tower2216and can increase the stiffness of the third tower2216in bending and/or in torsion.

In some embodiments, with reference toFIG.11G, the third tower2212can have one or more hooks2279(two being included in the illustrated embodiment) coupled with the reinforcing element2274. In some embodiments, the hooks2279coupled with the reinforcing element2274can be used to constrain one or more wires (such as, without limitation, wires140a,140b) during a procedure.

With reference toFIGS.11F and11G, some embodiments of the reinforcing element2274of the first tower2212can have a cutout2278(that can optionally be circular) formed therein that can receive a portion of an outside surface of the second tower2214therein. The cutout2278can be used to partially constrain the first tower2212with respect to the second tower2214, particularly when the first tower2212is moved to force the cutout2278into contact with the outside surface of the second tower2214. In some embodiments, the radius of the cutout2278can be less than a radius of the outside surface of the second tower2214. In other embodiments, the cutout2278can have a V shape.

Additionally, some embodiments of the reinforcing element2273of the third tower2216can have a cutout2280(that can optionally be circular) formed therein that can receive a portion of an outside surface of the second tower2214therein. The cutout2280can be used to partially constrain the third tower2216with respect to the second tower2214, particularly when the third tower2216is moved to force the cutout2280into contact with the outside surface of the second tower2214. In some embodiments, the radius of the cutout2280can be less than a radius of the outside surface of the second tower2214. In other embodiments, the cutout2280can have a V shape.

In some embodiments, the first, second, and third towers2212,2214,2216can be configured to be selectively removable from the first, second, and third screws2202,2204,2206. For example and without limitation, some embodiments of the first, second, and third towers2212,2214,2216can have one or more creases, fracture lines, or lines of weakness (for example, two creases, fracture lines, or lines of weakness) along a length of a wall portion of any or all of the first, second, and third towers2212,2214,2216. In some embodiments, a tool or other device can be used to fracture the first, second, and third towers2212,2214,2216along the one or more creases, fracture lines, or lines of weakness to remove the first, second, and third towers2212,2214,2216from the first, second, and third screws2202,2204,2206. In some embodiments, the one or more creases, fracture lines, or lines of weakness can be circumferentially arranged and positioned at or adjacent to a top surface of the screws that the towers are attached to so that the towers can break along the one or more creases, fracture lines, or lines of weakness at or adjacent to the screws and be removed.

In some embodiments, the first, second, and third towers2212,2214,2216can have distal end portions having circumferential, helical, and/or discrete/intermittent projections, tabs, lip(s), flanges, grooves, channels, detents, or other mechanically locking features that engage with complementary locking features of the screw heads to cause the first, second, and third towers2212,2214,2216to be coupled with the screw heads when the first, second, and third towers2212,2214,2216are intact, but which can each be decoupled from the complementary locking features of the screw heads when the first, second, and/or third towers2212,2214,2216are fractured or split apart. As another example, a third wall or connecting wall connecting two sides of any of the first, second, and/or third towers2212,2214,2216can have an angled or “V” shaped profile wherein a fracture line or line of weakness extends along the apex or angle of the angled or “V” shaped profile such that, when the two sides of the first, second, and third towers2212,2214,2216are squeezed toward one another, such force from the squeezing can cause a fracture along the fracture line or line of weakness in the connecting portion, thereby allowing the first and second sides of the tower to separate so that tower can be removed from the screw head. In some embodiments, a slider ring can be slid down the tower to cause the two sides of the tower to be squeezed toward one another. In some embodiments, the first, second, and third towers2212,2214,2216can have tabs that extend from the first, second, and third screw heads that can be broken off from the screw heads after implantation. In some embodiments, the first, second, and/or third towers can be removably coupled with the first, second, and/or third screws by rotating the first, second, and/or third towers into engagement with the first, second, and/or third screws, and removed in the opposite manner.

In other embodiments, the extensions can be removably coupled with the screws so that the entire extension can be removed from the screw and the patient intact and be reused in subsequent procedures. For example and without limitation, ball and detent removable coupling mechanisms can be used to removably couple the first, second, and third towers2212,2214,2216with the first, second, and third screw heads. Other conventional or desired coupling mechanisms can be used to removably couple the first, second, and third towers2212,2214,2216with the first, second, and third screw heads. In other embodiments, a plurality of wires (such as, for example and without limitation, wires140a,140bshown inFIG.1A) can be used to removably couple the first, second, and third towers2212,2214,2216with the first, second, and third screw heads, as described above with respect to the embodiments shown inFIGS.1A-1Z.

Some embodiments of methods for treating a spinal defect include implanting a first screw2202that is coupled with a first tower2212through the incision into a first vertebra, advancing a third tower2216that is coupled with a third screw2206through the cutout2224formed in the first tower2212and implanting the third screw2206into a third vertebra, and advancing a second tower2214that is coupled with a second screw2204through the cutout2244formed in the third tower2216and implanting the second screw2204into a second vertebra. In some embodiments, the second vertebra can be between the first and third vertebrae.

The surgeon or medical practitioner can move a proximal portion2212bof the first tower2212toward a proximal portion2216bof the third tower2216to cause the distal portion2212aof the first tower2212to move toward the distal portion2216aof the third tower2216, thereby causing a compressive force to be applied between the first, second, and third vertebrae. In some embodiments, the method can further include coupling a rigid connector or rod with the first screw2202, the second screw2204, and the third screw2206to generally fix a position of the first screw2202relative to the second screw2204and the third screw2206. Thereafter, the first, second, and third towers2212,2214,2216can be removed from the first, second, and third screws2202,2204,2206.

Any embodiments of the system2200disclosed herein can be configured for use in performing L4, L5 and S1 surgical procedures, as well as cortical screw trajectory procedures. Additionally, any embodiments of the system2200disclosed herein can be configured to enable compression, traction, and/or counter-torque all with one device, and the extensions can be configured to allow a tower, rod insertion, and rod reducer (using extended tabs with threads) with one device.

In any system embodiments disclosed herein, including without limitation the embodiments of the system2000,2200, any of the towers (also referred to herein as extensions) can have an open channel or opening along the length of at least a portion of the tower. The open channel or opening can, in some embodiments, reduce the torsional or bending stiffness of the tower during an implantation procedure—for example and without limitation, when counter-torque forces applied to the tower. Additional components and devices, such as the embodiments of the covers that are disclosed below, can be used to selectively reinforce or close at least a portion of the channel or opening to selectively increase a rigidity or stiffness of the tower. For example and without limitation, in some embodiments, a cover can be slid longitudinally over the channel or opening to selectively close the channel or opening or selectively increase a stiffness of the tower. The cover can have grooves or channels that can be used to guide the cover to be in contact with the tower at the desired location and also connect the cover to the tower to increase the stiffness of the tower at the location of the channel or opening. In some embodiments, the cover can be coupled with the tower after the rod or connecting element has been advanced or at least been partially advanced through the tower and/or screw heads. As mentioned, the closing of the open channel can, in some embodiments, aid in stabilizing the tower to aid final tightening of the locking cap and using the towers as a counter torque mechanism.

Systems, Devices and Methods ofFIGS.12A-12D

Additional embodiments of a system3000that can be used for stabilizing or treating spinal vertebrae through a skin incision are disclosed below. With reference toFIGS.12A-12D, some embodiments of the system3000can have a first tower3002, a second tower3004, and a cover (also referred to herein as a support cover) that can be selectively coupled with at least one of the first tower3002and the second tower3004, or any other towers of the system3000.

In any embodiments disclosed herein, any components, features, or other details of the system3000, including without limitation any embodiments of the first and second towers3002,3004, can have any of the components, features, or other details of any other system embodiments or towers or extensions of any of the other system embodiments disclosed herein or be used according to any of the steps of any other method embodiments disclosed herein, including without limitation any of the embodiments of the system200,300,400,2000, and/or2200or methods of use thereof described herein, in any combination with any of the components, features, or details of the system3000or methods of use disclosed herein. Similarly, any components, features, steps, or other details of any of the other system or method embodiments disclosed herein can have any of the components, features, steps, or other details of any embodiments of the system3000or methods of use thereof disclosed herein in any combination with any of the components, features, or details of the system.

Some embodiments of the system3000can be configured and/or optimized for use in robotic surgical procedures, just as with any of the other embodiments disclosed herein, including without limitation any embodiments of the system2200. For example and without limitation, in some embodiments, the proximal portions of the towers can be configured and optimized for grasping and locating by end effectors or robotic arms of a surgical robot. The proximal portions of the first and second towers3002,3004can have a curved portion for increased stiffness and a flat portion3012,3014, respectively, at a proximal end of the proximal portions of the first and second towers3002,3004. The flat portions3012,3014can be better suited for graspers, end effectors, or coupling mechanisms of surgical robotic systems.

In any system embodiments of the system3000disclosed herein, any of the towers3002,3004(also referred to herein as extensions) or any other towers of the system3000can have an open channel or opening along the length of at least a portion of the tower. In some embodiments, a cover3006(also referred to herein as a support cover) can be selectively coupled with the first tower3002, the second tower3004, and/or any other tower of the system3000. In some embodiments, the cover3006can be used to selectively reinforce or close at least a portion of the channel or opening of one or more of the towers to selectively increase a rigidity or stiffness of the tower. For example and without limitation, in some embodiments, the cover3006can be slid longitudinally over the channel or opening to selectively close the channel or opening or selectively increase a stiffness of the tower.

In some embodiments, with reference toFIG.12D, the tower can have grooves or channels3020formed along at least a portion of a length of the tower, e.g., extending proximally from a distal end portion of the tower, which are configured to receive a mating tabbed feature or projection3022formed on the cover3006. The grooves3020and projections3022can be configured to constrain the cover3006to the tower or couple the cover3006with the tower to increase the support that the cover3006provides to the tower when coupled together. The grooves3020and projections3022can be formed longitudinally along at least a portion of the length of the cover3006and the tower so that the projections3022may be slid into the channels3020as the cover3006is slid downward toward the distal end of the tower from outside the body. In some embodiments, the cover can be optimized for robotic surgical systems, such as by having a flat proximal portion that can be more easily grasped by the robot. In some embodiments, the cover can be coupled with the tower after the rod or connecting element has been advanced or at least been partially advanced through the tower and/or screw heads. As mentioned, the closing of the open channel can, in some embodiments, aid in stabilizing the tower to aid final tightening of the locking cap and using the towers as a counter torque mechanism.

Further, the ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “about” or “approximately” include the recited numbers and should be interpreted based on the circumstances (e.g., as accurate as reasonably possible under the circumstances, for example ±10%). For example, “about 7 mm” includes “7 mm” and numbers and ranges preceded by a term such as “about” or “approximately” should be interpreted as disclosing numbers and ranges with or without such a term such that this application supports claiming the number and ranges disclosed in the specification and/or claims with or without the term such as “about” or “approximately” before such numbers or ranges. Phrases preceded by a term such as “substantially” include the recited phrase and should be interpreted based on the circumstances (e.g., as much as reasonably possible under the circumstances). For example, “substantially straight” includes “straight.”