Patent Grant
11648128
This application is directed to medical devices and methods. More specifically, the application is directed to devices and methods related to use of a facet screw in various spine surgery procedures.
Chronic back problems are one of the most common causes of pain and disability in the United States and other developed countries, and they account for enormous economic costs. According to at least one estimate, spinal fusion procedures, in which two adjacent vertebrae are fused together using plates, screws and other implants, are the most commonly performed surgical procedures in the United States. Spinal fusion is often performed in conjunction with an attempt to increase space between the two adjacent vertebrae being operated on (spinal distraction) and to thus prevent impingement of the spinal cord or nerve roots branching from the spinal cord and passing through openings in the vertebral column (radiculopathy). Unfortunately, most techniques and devices used for performing spinal fusion are relatively invasive and involve a number of risks and difficult recovery and rehabilitation.
One of the reasons that spinal fusion surgery is often very invasive is that, due to the position of the spinal cord in back of (posterior to) the central vertebral bodies of spine, many of the procedures require entering the patient through the front of the body (an “anterior approach”) and dissecting through various tissues to gain access to the spine. Fusion procedures are often performed on the cervical spine (neck region), which requires dissecting through the neck, or the lumbar spine (lower back region), which requires dissecting through the abdomen. In either case, cutting through the anterior tissues of the patient to reach the spine is not without risk. Fusion procedures may also involve relatively large plates and screws, which require a relatively large surgical access field and thus more dissection of tissue than would be ideal. Not only are these invasive spinal fusion techniques potentially risky, but they are also expensive and typically require lengthy recovery and rehabilitation times.
Therefore, a need exists for alternative devices and methods for treating spinal instability and spinal stenosis, particularly via fusion of adjacent vertebrae. Such devices and methods may be minimally invasive or less invasive than many of the currently available techniques. For example, it may be advantageous to have devices and methods that use a posterior approach for accessing the spine. At least some of these objectives will be met by the embodiments described below.
Embodiments described herein address the challenges described above by providing a system for implanting facet screw assembly through a vertebra of a vertebral column of a patient.
Embodiments described herein address the challenges described above by providing a system for implanting a locking screw through a vertebra of a vertebral column of a patient, the locking screw extending near or through a facet screw in the vertebral column. In some embodiments, the locking screw is advanced through an opening in a facet screw that has been placed in a facet joint between two vertebrae, so that the locking screw attaches to one of the two vertebrae and thus helps secure the facet screw in place within the facet joint. In one embodiment, a system for implanting a locking screw includes a facet screw, a locking screw, a locking screw delivery mechanism detachably connected to the locking screw, and a guide tube configured to receive, at a proximal end of the guide tube, the locking screw and locking screw delivery mechanism and, at a distal end, the facet screw. The guide tube includes one or more bends, and as the locking screw is advanced through the guide tube along a first trajectory, the bend in the guide tube (or multiple bends) causes the locking screw to exit a distal end of the guide tube along a second trajectory. The angle of the second trajectory is generally such that the locking screw enters the facet screw and the vertebra at a desired angle for its intended purpose.
In one aspect, a system may be provided for implanting a locking screw into a vertebra of a vertebral column of a patient to help secure a facet screw within a joint between the vertebra and an adjacent vertebra. The system may include a facet screw, a locking screw, a locking screw delivery mechanism detachably connected to the locking screw, and a guide tube. The guide tube may include a proximal end, a distal end, a lumen configured to receive the locking screw and the locking screw delivery mechanism, and at least one bend disposed nearer the distal end than the proximal end. The bend (or bends) in the guide tube are designed to change a trajectory of the locking screw and the locking screw delivery mechanism advancing through the lumen from a first trajectory along a longitudinal axis of the guide tube to a second trajectory that is angled relative to the longitudinal axis. The second trajectory is designed to direct the locking screw out of the distal end of the guide tube and into the vertebra at a desired angle offset from the longitudinal axis of the facet screw to help secure the facet screw.
In some embodiments, the joint in which the system is used is a facet joint, and the implant is a facet screw. In such embodiments, the locking screw, the locking screw delivery mechanism and the guide tube may be designed to advance the locking screw through an opening in the facet screw and into the vertebra. In some embodiments, the bend in the guide tube changes the trajectory from the first trajectory to the second trajectory without assistance from a user of the system. In some embodiments, the locking screw delivery mechanism may be detachable from the locking screw by breaking the locking screw delivery mechanism off of the locking screw at a breakable junction. For example, the locking screw delivery mechanism may break off of the locking screw when a predetermined amount of force is applied to the locking screw delivery mechanism and a break in the junction occurs.
In some embodiments, the locking screw delivery mechanism includes a flexible region configured to flex when the delivery mechanism is advanced through the bend in the guide tube. In such embodiments, when the locking screw is engaged with the vertebra and the flexible region is flexed, a load may be concentrated at a breakable junction between the locking screw and the locking screw delivery mechanism. In some embodiments, the locking screw delivery mechanism detaches from the locking screw upon the breakable junction experiencing a predetermined load. Furthermore, in some embodiments, the locking screw and the locking screw delivery mechanism are a one-piece device with a breakable section between the locking screw and the locking screw delivery mechanism. In such embodiments, the locking screw detaches from the locking screw delivery mechanism when the locking screw breaks off of the locking screw delivery mechanism at the breakable section.
In another aspect, a device for securing an implant within a joint formed by two adjacent vertebrae may include an elongate locking screw delivery mechanism extending along a longitudinal axis from a proximal end to a distal end and a locking screw detachably connected to the distal end of the locking screw delivery mechanism. In some embodiments, the device may also include a breakable junction between the locking screw delivery mechanism and the locking screw, and the locking screw delivery mechanism is detachable from the locking screw by breaking the locking screw delivery mechanism off of the locking screw at the breakable junction. In some embodiments, the locking screw delivery mechanism breaks off of the locking screw when a predetermined amount of force is applied to the locking screw delivery mechanism and a break in the junction occurs. In some embodiments, the locking screw delivery mechanism includes a flexible region.
The locking screw may include a shaft extending from a screw head, the screw head being monolithically formed with the distal end of the delivery mechanism. In some embodiments, for example, the shaft extends from the screw head along the longitudinal axis. In some embodiments, the locking screw and the locking screw delivery mechanism are a one-piece device with a breakable section between the locking screw and the locking screw delivery mechanism.
In some aspects, a system for delivering a facet screw to a vertebra is disclosed. The system includes a facet screw and a guide tube having a proximal end, a distal end configured to receive the facet screw, and a lumen comprising a bend disposed nearer the distal end than the proximal end. The bend in the guide tube is configured to change a trajectory of a screw device advancing through the lumen from a first trajectory along a longitudinal axis of the guide tube to a second trajectory that is angled relative to the longitudinal axis. The second trajectory is configured to direct the screw device out of the distal end of the guide tube and into the facet screw and the vertebra at an angle offset from a longitudinal axis of the facet screw. In some aspects, the facet screw includes a proximal end and a distal end and a guide tube engagement feature positioned proximate the proximal end of the facet screw. The guide tube engagement feature includes one or more notches. The distal end of the guide tube includes one or more protrusions. The one or more notches are complementary to and receive the one or more protrusions such that the guide tube engagement feature and the distal end of the guide tube are releasably coupled together.
In some aspects, a system for delivering a facet screw assembly to a joint between a vertebra and an adjacent vertebra is disclosed. The system includes a facet screw assembly and a delivery device. The delivery device may include an actuator shaft having a distal threaded end configured to receive at least a portion of the facet screw assembly, a central sleeve defining a first longitudinally extending lumen, the central sleeve configured to receive the actuator shaft, and an outer sleeve having one or more notches at a distal end and further defining a second longitudinally extending lumen, the outer sleeve configured to receive the central sleeve. The one or more notches of the outer sleeve engage at least a second portion of the facet screw assembly to aid in delivery of the facet screw assembly. In some aspects, the facet screw assembly includes a facet screw having an elongated shaft with a proximal end and a distal end, a washer including: a base having an opening for engagement with the proximal end of the elongated shaft of the facet screw, and one or more protrusions extending longitudinally from the base, the protrusions having teeth extending therefrom. The facet screw assembly may also include a locking ring configured to secure the washer to the proximal end of the facet screw. In some aspects, the joint is a facet joint. In some aspects, the proximal end of the elongated shaft of the facet screw comprises internal threads configured for engagement with the actuator shaft of the delivery device. The distal end of the elongated shaft of the facet screw may include external threads configured for engagement with the facet joint. In some aspects, a channel is defined at least partially in the external threads of the facet screw and the channel may hinder rotation of the screw in the facet joint. In some aspects, the central sleeve has a hex shape to rotationally drive the facet screw. In some aspects, the proximal portion of the one or more protrusions of the washer are complementary to and received by the one or more notches at the distal end of the outer sleeve.
In some aspects, an intra-facet screw assembly is disclosed. The assembly includes a facet screw having an elongated shaft with a proximal end and a distal end. The assembly further includes a washer including a base having an opening for engagement with the proximal end of the elongated shaft of the facet screw and one or more protrusions extending longitudinally from the base, the protrusions having teeth extending therefrom. The assembly further includes a locking ring configured to secure the washer to the proximal end of the facet screw. In some aspects, a method of treating radiculopathy is disclosed. The method may include delivering the intra-facet screw assembly to a narrowed facet joint between a vertebra and an adjacent vertebra, and inserting the intra-facet screw assembly into the narrowed facet joint to expand the facet joint and increase foraminal height to decompress a nerve root, in addition to stabilizing and fixating the joint.
In some aspects, a trans-facet screw assembly is disclosed. The assembly includes a facet screw having an elongated shaft with a proximal end and a distal end. The assembly further includes a washer including a base having an opening for engagement with the proximal end of the elongated shaft of the facet screw and one or more protrusions extending longitudinally from the base, the protrusions having teeth extending therefrom. The assembly further includes a locking ring configured to secure the washer to the proximal end of the facet screw. In some aspects, a method of treating spinal instability is disclosed. The method may include delivering the trans-facet screw assembly through a facet joint between a vertebra and an adjacent vertebra, to stabilize an fixate the facet joint.
In another aspect, a system for delivering a facet screw assembly to a joint between a vertebra and an adjacent vertebra is disclosed. The system includes a facet screw assembly comprising a facet screw having a proximal portion and a distal portion and a delivery device including a proximal and distal end and defining a longitudinally extending lumen therethrough. The distal end of the delivery device may include a facet screw engagement feature. The facet screw engagement feature is keyed to a corresponding delivery device engagement feature located at or near the proximal portion of the facet screw.
In another aspect, a method for implanting a locking screw and a facet screw in a vertebra may involve inserting the locking screw and a locking screw delivery mechanism through a proximal end of a guide tube along a first trajectory, where a proximal end of the locking screw is attached to a distal end of the locking screw delivery mechanism, and a distal end of the guide tube, including a facet screw, is positioned adjacent the vertebra. The method may further involve advancing the locking screw and the locking screw delivery mechanism through a bend in the guide tube to cause the locking screw to exit the distal end of the guide tube along a second trajectory, through the facet screw and contact the vertebra. The method may also involve rotating the delivery mechanism to cause the locking screw to screw into the vertebra and detaching the locking screw delivery mechanism from the locking screw.
In some embodiments, the locking screw delivery mechanism is advanced through the guide tube in a straight direction along the first trajectory, and the bend in the guide tube automatically adjusts a path of travel of the locking screw delivery mechanism from the first trajectory to the second trajectory. In some embodiments, detaching the locking screw delivery mechanism from the locking screw comprises breaking the locking screw delivery mechanism off of the locking screw at a breakable junction. For example, breaking the locking screw delivery mechanism off of the locking screw may involve screwing the locking screw into the vertebra until a break in the junction occurs. More generally, breaking the locking screw delivery mechanism off of the locking screw may involve applying force to the locking screw delivery mechanism until a break in the junction occurs. In some embodiments, the locking screw and the locking screw delivery mechanism are a one-piece device with a breakable section between the locking screw and the locking screw delivery mechanism. In such embodiments, detaching the locking screw delivery mechanism from the locking screw may involve breaking the locking screw delivery mechanism off of the locking screw at the breakable section.
The method may further involve advancing the guide tube into the patient to position the distal end of the guide tube adjacent the vertebra. In some embodiments, this advancing of the guide tube involves advancing it through a larger guide tube previously placed in the patient proximate the vertebra.
In some embodiments, the step of advancing the locking screw may involve advancing the locking screw through an opening in a facet screw located in a facet joint formed by the vertebra and an adjacent vertebra. Optionally, the method may further involve, prior to the inserting step: advancing a larger guide tube into the patient from a posterior approach, to position a distal end of the larger guide tube in the facet joint; implanting the facet screw in the facet joint through the larger guide tube; and positioning the guide tube in a desired position for advancing the locking screw through the facet screw. In some embodiments, when the locking screw is engaged with the vertebra and the flexible region is flexed, a load is concentrated at a breakable junction. In some embodiments, the locking screw delivery mechanism detaches from the locking screw upon the breakable junction experiencing a predetermined load.
In another aspect, a method for implanting a locking screw through a facet screw to attach to a vertebra may involve: advancing a guide tube into the patient to position a distal end of the guide tube adjacent the facet joint; inserting a distal end of a locking screw delivery mechanism through the guide tube along a first trajectory; advancing the locking screw delivery mechanism through a bend in the guide tube to cause a distal locking screw portion of the locking screw delivery mechanism to exit the distal end of the guide tube along a second trajectory and advance through an opening in the facet screw at an angle; rotating the locking screw delivery mechanism to cause the distal locking screw portion to screw into the vertebra to secure the facet screw to the vertebra; and breaking a proximal elongate shaft portion of the locking screw delivery mechanism off of the distal locking screw portion at a breakable junction between the two portions.
Advancing the locking screw delivery mechanism may involve advancing the locking screw delivery mechanism in a straight direction along the first trajectory, where the bend in the guide tube automatically adjusts a path of travel of the locking screw delivery mechanism from the first trajectory to the second trajectory. In some embodiments, breaking the proximal elongate shaft portion off of the distal locking screw portion involves screwing the distal locking screw portion into the vertebra until a break in the breakable junction occurs. In other embodiments, breaking the proximal elongate shaft portion off of the distal locking screw portion comprises applying force to the proximal elongate shaft portion until a break in the breakable junction occurs. In some embodiments, the proximal elongate shaft portion and the distal locking screw portion are a one-piece device with the breakable junction between them.
In another aspect, a method is provided for implanting a locking screw in a vertebra at or immediately adjacent a facet screw disposed in a spinal joint formed by the vertebra and an adjacent vertebra. The method may first involve inserting a locking screw delivery mechanism through a proximal end of a guide tube along a first trajectory, where a distal end of the locking screw delivery mechanism is attached to a proximal end of the locking screw, and where a distal end of the guide tube is positioned proximate the facet screw. The method may next involve advancing the facet screw delivery mechanism through one or more bends in the guide tube to cause the facet screw to exit the distal end of the guide tube along a second trajectory and contact the vertebra. The method may further involve rotating the delivery mechanism to cause the locking screw to screw into the vertebra to help secure the facet screw within the spinal joint and separating the locking screw delivery mechanism from the locking screw. In some embodiments, the locking screw may be advanced through an opening in the facet screw to contact the vertebra. In some embodiments, the spinal joint is a facet joint.
In another aspect, a facet screw assembly delivery system is disclosed. The system comprises a facet screw assembly and an articulating delivery device. The delivery device includes a facet screw delivery lumen, a spacer delivery lumen and an actuator rod having a knob and a spacer engagement member configured for receipt in the spacer delivery lumen.
In another aspect, a system for delivering a facet screw assembly to a joint between a vertebra and an adjacent vertebra is disclosed. The system comprises a facet screw assembly and a delivery device. The delivery device includes a first lumen configured for delivery of a facet screw, a second lumen configured for delivery of a rotatable spacer, the lumens coupled together in a coplanar orientation, and an actuator rod having a knob and a spacer engagement member configured for receipt in the spacer delivery lumen.
In either or both systems, the facet screw assembly comprises a facet screw having an elongated shaft with a proximal end and a distal end, and a rotatable spacer. The rotatable spacer includes a base having a rotatable member including a rod opening, the rod opening configured to receive the actuator rod and one or more protrusions extending longitudinally from the base, the protrusions having teeth extending therefrom. The actuator rod engages the rod opening to rotate the rotatable member. Either or both systems may further comprise a connecting member coupling the lumens together.
In some aspects, the spacer delivery lumen has a length and the facet screw delivery lumen extends less than a full length of the spacer delivery lumen.
In some aspects, the second lumen has a length and the first lumen extends less than a full length of the second lumen.
In some aspects, the joint is a facet joint.
In some aspects, an intra-facet screw assembly is disclosed. The assembly includes a facet screw having an elongated shaft with a proximal portion and a distal portion and a spacer. The spacer includes a base having a rotatable member including a rod opening, the rod opening configured to receive an actuator rod, and one or more protrusions extending longitudinally from the base, the protrusions having teeth extending therefrom.
In some aspects, a method of treating radiculopathy is disclosed. The method comprises delivering the intra-facet screw assembly as disclosed herein to a narrowed facet joint between a vertebra and an adjacent vertebra and inserting the intra-facet screw assembly into the narrowed facet joint to expand the facet joint and increase foraminal height to decompress a nerve root.
In some aspects, an intra-facet screw assembly is disclosed. The assembly comprises a facet screw having an elongated shaft with a proximal portion having a head and a distal portion including threads and a spacer. The spacer comprises a first portion having an intrafacet engagement portion and a second portion having a lateral mass engagement portion, each portion further including a facet screw opening configured to receive at least a portion of the facet screw.
In some aspects of the assembly, the first portion comprises one or more surfaces having teeth extending therefrom. In some aspects, the second portion comprises one or more surfaces configured for engagement with at least a portion of a lateral mass of a vertebra.
In some aspects, a facet screw assembly delivery system is disclosed. The system comprises a facet screw assembly and a delivery device. The delivery device comprises a facet screw delivery lumen coupled to and positioned in parallel to a spacer delivery lumen and an actuator rod having a knob and a spacer engagement member configured for receipt in the spacer delivery lumen.
In some aspects, the facet screw assembly comprises a facet screw having an elongated shaft with a proximal portion having a head and a distal portion including threads and a spacer comprising a first portion having an intrafacet engagement portion and a second portion at an angle relative to the first portion, the second portion having a lateral mass engagement portion, each portion further including a facet screw opening configured to receive at least a portion of the facet screw. In some aspects of the system, the angle between the first portion and the second portion is an acute angle or less than 90 degrees, preferably approximately 45-60 degrees.
A method of treating radiculopathy is disclosed. In some aspects, the method comprises delivering the intra-facet screw assembly as disclosed herein or the facet screw assembly delivery system as disclosed herein to a narrowed facet joint between a vertebra and an adjacent vertebra and inserting the assembly or delivery device into the narrowed facet joint to expand the facet joint and increase foraminal height to decompress a nerve root.
In some embodiments, a facet screw assembly delivery system may include a facet screw assembly, a facet access guide, a washer sizer tool configured to removably engage with the facet access guide, a lateral mass decorticator guide configured to slidably and removably engage with the washer size tool, a washer implant delivery tool configured to removably engage with the facet access guide and detachably couple to the facet screw assembly, and an impact handle configured to detachably couple to the facet access guide, the washer sizer tool, and the washer implant delivery tool.
In some embodiments, the facet screw assembly includes facet screw having an elongated shaft with a proximal end and a distal end, a washer implant including a lateral mass engagement portion, an intrafacet engagement portion, a facet screw opening extending through the lateral mass engagement portion and the intrafacet engagement portion, the facet screw opening configured to accept the distal end of the facet screw, a keyway configured to align with a keyed feature on the washer implant delivery tool to maintain a position of the washer implant during delivery, and a coupling member configured to detachably couple the washer implant to the washer implant delivery tool.
In some embodiments, the facet access guide includes a proximal end including an instrument guide handle portal that is parallel to an impact handle socket, a ramped distal end including an intra-facet distractor and depth stop adjacent the intra-facet distractor, and an instrument guide portal formed an open channel and extending between the proximal end and the distal end.
In some embodiments, the washer sizer tool includes an access guide interface configured to engage with a facet access guide, a joint spacer positioned at a distal end of the washer size tool, the joint spacer angled with respect to a central portion of the washer sizer tool, a pin positioned adjacent the joint spacer and configured to engage with the facet access guide, an alignment feature extending from a posterior side of the washer sizer tool and configured to slidably engage with the lateral mass decorticator guide, and a washer size marker configured to provide a user with information regarding a recommended size of the facet screw assembly.
In some embodiments, the washer implant delivery tool includes a shaft, a rotatable washer release knob adjacent a proximal end of the shaft, an actuation rod coupled to the rotatable washer release knob and extending through at least a portion of the shaft, the actuation rod including a distal end configured to engage the facet screw assembly, a facet screw guide positioned at an angle with respect to the shaft and including a facet screw portal extending through the facet screw guide, and a key feature configured to align with a keyway feature on facet screw assembly to maintain a position of the face screw assembly during delivery.
In some embodiments, a system for delivering a facet screw assembly to a joint between a vertebra and an adjacent vertebra includes a facet screw assembly, a delivery device including a facet access guide, a washer implant delivery tool configured to removably engage with the facet access guide and detachably couple to the facet screw assembly, an impact handle configured to detachably connect to the facet access guide and the washer implant delivery tool.
In some embodiments, a method of delivering a facet screw assembly to a facet joint using a facet screw assembly delivery system includes placing a facet access guide into the facet joint, detachably coupling a washer sizer tool with the facet access guide, disconnecting an impact handle from the facet access guide and detachably coupling the impact handle to the washer sizer tool, impacting the impact handle to position the washer sizer tool in an appropriate location with respect to the facet joint, coupling a lateral mass decorticator guide with the washer sizer tool, contacting a lateral mass of the facet joint with the lateral mass decorticator tool, advancing a decorticator through a tool guide of the lateral mass decorticator guide and decorticating the lateral mass, determining a recommended facet screw assembly size for the facet joint, selecting a facet screw assembly size and coupling a component of the facet screw assembly to a washer implant delivery tool, decoupling the lateral mass decorticator guide and washer sizer tool from the facet access guide, coupling the impact handle to the washer implant delivery tool, coupling the washer implant delivery tool to the facet access guide and impacting the impact handle to position the component of a facet screw assembly into the facet joint, drilling a pilot hole across the facet joint, advancing a facet screw through the pilot hole and placing the facet screw across the facet joint, tightening the facet screw onto the component of a facet screw assembly and compressing the facet joint, decoupling the washer implant delivery tool from the facet screw assembly, and removing the washer implant delivery tool and facet access guide from the facet joint. In some embodiments, the method includes accessing the surgical site using angled instruments configured to reduce tissue incision size or instrument footprint.
In some embodiments, a facet screw assembly includes a facet screw having an elongated shaft with a proximal end and a distal end, a washer implant including a lateral mass engagement portion, an intrafacet engagement portion, a facet screw opening extending through the lateral mass engagement portion and the intrafacet engagement portion, the facet screw opening configured to accept the distal end of the facet screw, a keyway configured to align with a keyed feature on a washer implant delivery tool to maintain a position of the washer implant during delivery, and a coupling member configured to detachably couple the washer implant to the washer implant delivery tool.
In some embodiments, a facet access guide includes a proximal end including an instrument guide handle portal that is parallel to an impact handle socket, a ramped distal end including an intra-facet distractor and depth stop adjacent the intra-facet distractor, and an instrument guide portal formed an open channel and extending between the proximal end and the distal end.
In some embodiments, a washer sizer tool includes an access guide interface configured to engage with a facet access guide, a joint spacer positioned at a distal end of the washer size tool, the joint spacer angled with respect to a central portion of the washer sizer tool, a pin positioned adjacent the joint spacer and configured to engage with the facet access guide, an alignment feature extending from a posterior side of the washer sizer tool and configured to slidably engage with the lateral mass decorticator guide, and a washer size marker configured to provide a user with information regarding a recommended size of a facet screw assembly.
In some embodiments, a washer implant delivery tool includes a shaft, a rotatable washer release knob adjacent a proximal end of the shaft, an actuation rod coupled to the rotatable washer release knob and extending through at least a portion of the shaft, the actuation rod including a distal end configured to engage a facet screw assembly, a facet screw guide positioned at an angle with respect to the shaft and including a facet screw portal extending through the facet screw guide, and a key feature configured to align with a keyway feature on the facet screw assembly to maintain a position of the facet screw assembly during delivery.
In some embodiments, a system for delivering a facet screw assembly to a joint between a vertebra and an adjacent vertebra while reducing tissue incision size includes a facet screw assembly, an angled delivery device including an angled facet access guide, a washer implant delivery tool configured to removably engage with the facet access guide and detachably couple to the facet screw assembly, and an impact handle configured to detachably connect to the facet access guide and the washer implant delivery tool.
In some embodiments, a system for delivering a facet screw assembly to a joint between a vertebra and an adjacent vertebra includes a facet screw assembly, a non-linear delivery device including a non-linear facet access guide, a washer implant delivery tool configured to removably engage with the facet access guide and detachably couple to the facet screw assembly, and an impact handle configured to detachably connect to the facet access guide and the washer implant delivery tool.
In some embodiments, a facet screw assembly includes a trans-facet screw having an elongated shaft with a proximal portion and a distal portion; an intra-facet screw having an elongated shaft with a proximal portion and a distal portion; a washer including an intra-facet threaded aperture extending through a length of or along a longitudinal axis of the washer; and a trans-facet aperture extending through a width of or along a transverse axis of the washer. When assembled, the trans-facet screw is positioned within the trans-facet aperture and the intra-facet screw is positioned within the intra-facet aperture, and the washer is configured to be positioned in a facet joint.
In some aspects, the washer includes a reduced thickness, with the height of the washer at a first end being larger than a height of a second end of the washer along the length of the intra-facet threaded aperture. In some aspects, the second end of the washer is configured to expand in a width-direction as the intra-facet screw is inserted. In some embodiments, the assembly further includes a pivoting plate rotatably coupled to the first end of the washer, wherein the pivoting plate is configured to pivot about the first end of the washer.
In some embodiments, a facet implant assembly includes a facet screw with a first end and a tapered, threaded end opposite the first end; a cylindrical expandable spacer coupled to the first end of the facet screw, wherein the expandable spacer is configured to rotate in unison with the facet screw when coupled to the face screw, and a compression nut; wherein in a deployed position, the spacer is configured to expand to distract the facet joint and maintain the distracted aspect; and wherein the compression nut is threadably coupled to the first end of the facet screw to fixate the facet screw across the facet joint.
In some embodiments, a facet implant assembly includes a first facet implant comprising a screw and a polyaxial head with a rod receiving feature; a second facet implant comprising a screw and a polyaxial head with a rod receiving feature; and a rod; wherein in a deployed position, the first facet implant is configured to be deployed across a first facet joint and the second facet implant is configured to be deployed across a second facet joint, and a portion of the rod is positioned within each of the rod receiving features of the first facet implant and the second facet implant to couple the first facet implant with the second facet implant.
In some aspects, the first facet implant is deployed across the first facet joint in a trans-facet manner and the second facet implant is deployed across the second facet join in a trans-facet manner. In some aspects. the first facet implant is deployed across the first facet joint in an intra-facet manner and the second facet implant is deployed across the second facet join in an intra-facet manner.
In some embodiments, a facet implant assembly includes a first facet implant comprising a polyaxial head with a rod receiving feature; a second facet implant comprising a polyaxial head with a rod receiving feature; a first cage implant; and a rod; wherein in a deployed position, the first facet implant and optionally, the first cage implant, are configured to be deployed in an intra-facet manner adjacent one another between a first vertebra and a second vertebra; the second facet implant and optionally, a second cage implant, are configured to be deployed in an intra-facet manner adjacent one another between a second vertebra and a third vertebra; and wherein a portion of the rod is positioned within each of the rod receiving features of the first facet implant and the second facet implant to couple the first facet implant with the second facet implant.
In some embodiments, a system for delivering a facet screw assembly to a joint between a vertebra and an adjacent vertebra includes a facet screw assembly; and a delivery device including a screw driver configured to drive a facet screw into the joint; a screw driver locking collar positioned about a portion of the screw driver shaft and configured to engage the screw driver to engage with the facet screw assembly; and a screw expander driver positioned within a lumen of the screw driver configured to expand the facet screw assembly into a deployed configuration once the facet screw assembly is driven into the facet joint.
In some aspects, the facet screw assembly includes a screw and a screw expander, and wherein the screw expander is configured to splay an end of the screw when the facet screw assembly is in a deployed configuration. In some aspects, the screw expander is a retracting ball expander. In some aspects, the ball expander is positioned adjacent a first end of the screw expander so that threaded portions of the screw expander extend from both sides of the ball expander, and the first end of the screw expander is configured to remain within the facet joint space when the facet screw assembly is in a deployed configuration.
In some embodiments, a system for delivering a facet screw assembly to a joint between a vertebra and an adjacent vertebra includes a facet screw including a screw body including self-tapping threads; and a head including a first keyway and a second keyway, wherein an outer circumference of the head includes teeth; wherein the teeth have alternating teeth angles and are positioned on two sides of the head; a delivery device comprising a driver including a shaft with a keyed first end and a handle opposite the first end; and a holder including a tapered end with at least one arm extending from the taper end, wherein the keyed first end of the driver is configured to engage with the first keyway of the facet screw, and the arm of the holder is configured to engage with the second keyway of the facet screw.
These and other aspects and embodiments will be described in further detail below, in reference to the attached drawing figures.
Aspects of the present disclosure generally involve devices and methods for treating spinal instability, spinal stenosis and radiculopathy. Spinal stenosis reflects a narrowing of one or more areas of the spine, often in the upper or lower back. This narrowing can put pressure on the spinal cord or on the nerves that branch out from the compressed areas (radiculopathy). Individual vertebrae of the spine are positioned relative to each other, and their separation is maintained by discs separating main vertebral bodies and by capsules positioned within facet joints. The discs and capsules are separated from the bone of their respective joints by cartilage. Spinal stenosis is often indicative of degeneration of a disc, a capsule, or the cartilage in a joint, which leads to a compression of the joints and the narrowing mentioned.
Various embodiments of a device, system and method are described herein for posterior fixation of two adjacent vertebrae of a spine, in an effort to ameliorate spinal instability, spinal stenosis and radiculopathy. Some embodiments involve delivery of the fixation device from a posterior approach.
Facet screws are commonly used in spine surgery as a means for posterior fixation. The screw consists of either a cannulated or solid screw and with or without a head washer. Typically, a facet screw is placed across the facet joint to provide posterior fixation. The concern with placing a screw across the facet joint is that it may potentially compress the joint and narrow the foraminal space where the nerve root resides causing foraminal stenosis.
In addition, there are challenges in placing the facet screw in the posterior spine, such as the cervical, thoracic, and/or lumbar spine, such as ensuring proper trajectory across the facet joint, preventing bone breach which may cause nerve or tissue damage, and properly anchoring the screw in bone to prevent screw backout.
In some cases, it may be possible to insert a fixation device, such as a facet screw or facet screw assembly, into a facet joint by itself and, due to the design of the facet screw, do nothing further to secure the facet screw within the joint. In other words, the shape, size, surface features and overall configuration of the facet screw may cause it to remain securely within the facet joint without further attachment devices required. In some cases however, and in general for overall safety of a facet joint distraction procedure, it may be advantageous to use one or more additional devices to help secure the facet screw to one or both of the adjacent vertebrae that form the joint. Such an additional device may include a screw, anchor, washer or similar securement device, and it may help to maintain the facet screw in a desired position within the joint and to prevent it from “backing out” of the joint—i.e., slipping posteriorly out of the joint. In such embodiments, a locking screw may be delivered through an opening in a facet screw or adjacent the facet screw, so that the locking screw is attached to one of the vertebrae that form the facet joint, to help secure the facet screw within the joint. Thus, although this detailed description focuses on embodiments in which the locking screw is advanced through an opening in a facet screw to secure the facet screw in a facet joint, alternative embodiments may use the locking screw system, device and method in other ways within the spine.
In one embodiment, a system for delivering a facet screw assembly to a joint between a vertebra and an adjacent vertebra may include the facet screw assembly. The facet screw assembly includes a facet screw having a proximal portion and a distal portion. The system also includes a delivery device, which may include a proximal end and a distal end and the delivery device defines a longitudinally extending lumen therethrough. In one aspect, the distal end of the delivery device may include a facet screw engagement feature. The facet screw engagement feature may be keyed to a corresponding delivery device engagement feature located at or near the proximal portion of the facet screw.
In some embodiments, the system may include a locking screw and a locking screw delivery mechanism for anchoring an implant, such as a facet screw, into a facet joint, and for distracting and maintaining the distracted position of the joint. In one embodiment, the locking screw is detachably connected to a locking screw delivery mechanism. The system may also include a guide tube for delivering the implant and to guide the locking screw to the implant. The locking screw is caused to detach from the delivery mechanism upon the locking screw becoming sufficiently secured to the implant and facet joint. This approach may ensure that the implant is securely affixed to the facet joint, for maintaining the distraction of the joint, thereby relieving symptoms associated with spinal stenosis.
In one particular aspect, the system includes a locking screw detachably connected to a delivery mechanism at a breakable junction, and a guide tube configured to receive the locking screw and delivery mechanism. The guide tube may include a bend, and as the locking screw and delivery mechanism is advanced through the guide tube along a first trajectory, the bend causes the locking screw to exit a distal end of the guide tube along a second trajectory. The delivery mechanism may include a flexible region, which flexes as it advances through the bend in the guide tube. In some embodiments, the guide tube may include multiple bends. The bend (or bends) in the guide tube are configured to direct the locking screw out of the distal end of the guide tube at a desired angle, such as an angle that will direct the locking screw through an opening in an implant and into one of two adjacent vertebrae. As the locking screw is screwed into vertebral bone, the flexible region of the delivery mechanism continues to flex, and a load is concentrated at the breakable junction. Upon the locking screw becoming sufficiently secured to the vertebral bone, the breakable junction experiences a predetermined load to cause the locking screw to detach from the delivery mechanism.
As shown in
Referring to
As can be understood from
Now turning to
As shown in
The inner guide tube 350 is configured to receive the locking screw device 101 and guide the locking screw 102 to the implant, such as facet screw 200. The distal end 305 of the implant delivery device 300 is engaged with the implant or facet screw 200. In one embodiment, the facet screw includes recesses 310 defined in the washer. The recesses are complementary to protrusions 320 at the distal portion of the implant delivery device 300.
Thus, as the locking screw device 101 is advanced through the inner guide tube 350, the locking screw 102 may exit the tube and engage the implant. A user may then continue to advance the locking screw 102 through the implant 200 by rotating the locking screw device 101, and thus cause the screw 102 to screw into the implant 200 and into the patient's vertebra. The inner guide tube 350 may include a proximal portion that extends longitudinally along Axis-A and a distal portion that extends along Axis-B, wherein the proximal portion and distal portion are joined at a bend 303. Axis-B may extend upward from Axis-A at an angle. As shown, the channel 220 of the facet joint implant 200 may extend at an angle. The angle of the bend, together with the angle of the channel, may be configured to cause the locking screw 102 to detach from the delivery mechanism 104 upon securing the implant 200 to a vertebra of a patient's facet joint. As the locking screw 102 is advanced through the inner guide tube 350, the bend 303 in the inner guide tube 350 may be configured to cause the flexible region of the delivery mechanism 104 to flex. When the locking screw 102 is screwed into the implant 200 and vertebra a predetermined amount (e.g., to fully secure the implant 200 into the vertebra), the locking screw 102 may become stabilized so that the flexing or bending force is concentrated at the breakable junction 122. As such, when a user further secures the screw 102, the force on the breakable junction reaches a threshold and causes the junction 122 to break, thus detaching the locking screw 102 from the delivery mechanism 104. Thus, the implant delivery device 300 may facilitate a user in securing the locking screw 102 into an implant 200 and vertebra a sufficient amount.
As described elsewhere herein, the implant 200 may be a facet screw. As shown in
In another embodiment, as shown in
In some embodiments, the facet screw assembly 400 may be part of a system. The system may further include a delivery device 500, as shown in
In some embodiments, the elongated shaft of the facet screw includes internal threads 411. The internal threads 411 engage with the threads 502 of the distal end 505 of the actuator shaft 501 of the delivery device, as shown in
In some embodiments, the facet screw assembly and the delivery system associated with it are useful for a transfacet approach. In such embodiments, the facet screw assembly also comprises a facet screw and a washer (also referred to in these embodiments as a spacer), but the delivery system is different from other embodiments. Turning now to
In some aspects, the delivery system 600 further comprises a rod 645 having a proximal portion with a knob 650 and a distal portion 655 for engagement with the spacer. The distal portion 655 may include threads.
As depicted in
Turning now to
In this embodiment, and as shown in
In some aspects, the delivery system 800 further comprises a rod 840 having a proximal portion with a knob 845 and a distal portion 850 for engagement with the spacer. The distal portion 850 may include threads (not shown).
Turning now to
In one implementation, the system 900 includes a delivery tool 902 and a guide tool 904, both of which extend from a respective leading distal end 906, 907 to a respective trailing proximal end 908, 909. As can be understood from
The delivery system components depicted in
With the place holding or access chisel so positioned, the guide tool is grasped and distally routed over the chisel 974 such that the chisel shaft is received in the guide tool lumen that extends longitudinally through the guide tool shaft. The tapered forked distal end of the guide tool 904 is distally advanced through the incision and along the chisel shaft until the tapered forks of the guide tool 904 are positioned inside the target facet joint, the chisel tapered distal tip being located between the pair of forks of the guide tool distal end, the guide tool shaft extending out of the patient via the incision.
With the guide tool 904 so positioned, the place holding or access chisel 974 can be withdrawn out of the guide tool lumen and out of the patient, leaving the guide tool tapered forked distal end residing in the target facet joint and the guide tool shaft extending out of the patient. The decorticating chisel 960 can then be distally routed through the lumen of the guide tool 904 to place the tapered decorticating distal end of the chisel 960 between the guide tool forks located in the target facet joint space. The decorticating chisel 960 can then be displaced distal-proximal to cause the tapered decorticating distal end of the chisel 960 to remove the cartilage of the target facet joint space located between the guide tool forks and further decorticate any associated bone surfaces of the target facet joint space. Once the target facet joint space surfaces have been prepped with the decorticating chisel 960, the chisel 960 can be removed from the lumen of the guide tool 904 and the patient.
In some embodiments, the implant 200 may be coupled to, and supported off of, the distal end 906 of an implant delivery tool. Once the implant 200 is decoupled from the delivery tool and delivered or deposited into the facet joint space, the delivery tool can be withdrawn from the guide tool 904, which is left in place with its forked distal end occupying the facet joint space and the implant 200 being located between the forks of the guide tool 904.
When the delivery tool 902 is withdrawn from the guide tool 904, and the implant 200 is located as desired, a user may insert the implant delivery device 300 through the lumen of the guide tool 904 to deliver the locking screw 102 and thus anchor the implant 200 to the vertebra. For example, a user may insert the implant delivery device 300 through the lumen of the guide tool 904 such that the distal end of the inner guide tube 350 is proximate the facet implant, such as the facet screw 200. The user may insert the locking screw device 101 through a proximal end of the inner guide tube 350 and advance the locking screw device 101 through the proximal portion of the inner guide tube 350 along a first trajectory. The user may continue to advance the locking screw device 101 through the inner guide tube, and the bend within the guide tube may cause the flexible region 126 of the delivery mechanism 104 to flex. Thus, the locking screw 102 may exit the distal end of the inner guide tube 350 along a second trajectory so that the locking screw 102 is directed to the channel 220. When the locking screw 102 is within the channel 220, the user may rotate the locking screw device 101 to cause the locking screw 102 to advance through implant 200 and into the vertebra. The locking screw 102 may advance through the implant 200 and into the vertebra along a third trajectory. As the user further screws the screw 102 into the implant 200 and vertebra, the flexible region 126 further flexes and a load is concentrated at the breakable junction 122. When the user screws the screw 102 a sufficient amount to anchor the implant 200 to the vertebra, the breakable junction 122 may experience a predetermined load to cause the bone screw 102 to detach from the delivery mechanism 104. The process can then be repeated for another facet joint if needed.
In one embodiment, a system for delivering a facet screw assembly to a joint between a vertebra and an adjacent vertebra may include the facet screw assembly. The facet screw assembly includes a facet screw that interfaces with a washer that is deployed in the facet joint to distract or maintain the facet joint space thereby reducing or preventing radiculopathy. The washer may also be used as an additional anchoring point for the screw to reduce the likelihood of screw backout. The interface between the washer and the screw provides a fixed length for the screw to protrude beyond the facet joint and into bone which makes the placement of the screw predictable and minimizes bone breach and potential nerve or tissue damage to the patient.
In some embodiments, the instruments that interface with the screw and washer provide a way to place the facet screw assembly while minimizing the required tissue incision size typically seen in facet screw placement. The instruments also provide a way to decorticate the lateral mass to prepare for fusion. The instruments guide the facet screw at a fixed angle across the facet joint, eliminating the variability by doing it with other methods.
The embodiments of the current disclosure may be an improvement over traditional facet screws placed across the facet joint with a transfacet approach. The traditional transfacet approach compresses the facet joint, narrows the lateral foramen, and potentially induces spinal stenosis. In addition, the traditional approach does not decompress the nerve root. Another traditional method is the use of bone dowels, where the bone dowels are placed within the facet joint to expand and fuse the joint. However, this approach may require further instrumentation to fixate the joint and/or spine construct, to allow for fusion.
The facet access guide 1100 includes a posterior side 1198, an anterior side 1197, and a distal end formed as ramp 1120 including an intra-facet distractor 1108 and a stop or depth stop 1106. The facet access guide 1100 also includes a proximal end formed by an instrument guide handle portal 1110 and impact handle socket 1122. An instrument guide portal 1104 is positioned between the ramp 1120 and the combination of the instrument guide handle portal 1110 and impact handle socket 1122. The instrument guide portal 1104 includes an upper portion 1116 and a lower portion 1118. The upper portion 1116 is positioned adjacent the instrument guide handle portal 1110. The lower portion 1118 is adjacent the ramp 1120.
Referring to
The upper portion 1116 of the instrument guide portal 1104 may be generally coaxial with the axis 1124 of the instrument guide handle portal 1110. The upper portion 1116 may form an open lumen or channel, such as a generally half-cylindrical channel with an open side or a u-shaped channel, with an opening directed towards a posterior side 1198 of the facet access guide 1100. The upper portion 1116 is angled with respect to the lower portion 1118. The lower portion 1118 may also form a channel, such as generally half-cylindrical channel with an open side or a u-shaped channel, with an opening directed towards the posterior side 1198 of the facet access guide 1100.
Referring to
At the end of the ramp 1120 may be the intra-facet distractor 1108. The intra-facet distractor 1108 may be used to distract a target facet joint to prepare the joint for insertion, coupling, or receipt of a facet screw assembly. The ramp 1120 and intra-facet distractor 1108 may form a fork like shape that may aid in preparation of the facet joint by partially or fully distracting the facet joint or at least anchoring the tool in the joint. A stop or depth stop 1106 may also be positioned at the end of the ramp 1120. In use, the depth stop 1106 may positively locate the intra-facet distractor 108 and prevent the intra-facet distractor 1108 from extending too far or being inserted to an undesired depth into the facet joint.
In some examples and in use, the angled or non-linear shape of the facet access guide 100 may reduce tissue incision size and/or instrument footprint for distracting a facet joint and inserting a facet screw assembly.
The delivery system of
The delivery system may also include a washer sizer tool 1200 and a lateral mass decorticator guide 1300. The washer sizer tool 1200 may include an anterior side 1297, a posterior side 1298, and an access guide interface 1202, which extends from a central portion of the washer sizer tool 1200 on the anterior side 1297 down to a distal end. The access guide interface 1202 may be shaped to engage, fit adjacent to or detachably couple with the instrument guide portal 1104 of the facet access guide 1100. For example, the access guide interface 1202 may be cylindrical or u-shaped to fit at least partially within and slide with respect to the posterior side 1198 of the instrument guide portal 1104 of the facet access guide 1100. The access guide interface 1202 may include an upper portion 1216 and a lower portion 1218. The lower portion 1218 may be generally coaxial with a washer sizer shaft 1212, which is positioned adjacent the upper portion 1216. The upper portion 1216 may be angled with respect to the lower portion 1218 and the washer sizer shaft 1212. The angle and shape of the upper portion 1216 is configured to align with the upper portion 1116 of the facet access guide 1100.
The upper portion 1216 may also include a threaded socket configured so that the washer sizer tool 1200 may be detachably coupled with the impact handle 1102 (as shown assembled in
At the distal end of the washer sizer tool 1200 is a joint spacer 1206. The joint spacer 1206 is shaped to be positioned and slide along the ramp 1120 and between the forks that form the intra-facet distractor 1108 on the posterior side 1198 of the facet access guide 1100. The joint spacer may include teeth extending from its sides to help position the joint spacer 1206 within the facet joint and to also help decorticate the facet joint in preparation for the installation of the facet screw assembly.
A dovetail feature 1222 may be formed on the posterior side 1298 of the washer sizer tool 1200. The dovetail feature 1222 may extend along at least half a length of the washer sizer tool 1200, and is configured to align with a corresponding dovetail feature on the lateral mass decorticator guide 1300. This may allow the lateral mass decorticator guide 1300 to be fixedly axially located with respect to the washer sizer tool 1200, but allows the lateral mass decorticator guide 1300 to be translated or slid up and down along the washer sizer tool 1200.
As shown in
The posterior side of the washer sizer tool 1200 may also include a pin 1220, or posts that extends away from, in a lateral medial direction, the general body of the washer sizer tool 1200 adjacent the joint spacer 1206. In use, the post or pin 1220 may align with the ramp 1120 of the facet access guide 1100 to help guide the washer sizer tool 1200 during the facet screw assembly installation procedure. For example, the pin may slide or ride against the edge of the ramp to help ensure alignment of the washer sizer tool 1200 with respect to the facet access guide 1100.
The lateral mass decorticator guide 1300 is also shown in
In some examples, the lateral mass decorticator guide 1300 includes a dovetail feature 1322 that extends from the anterior side 1397 of the lateral mass decorticator guide 1300 and is configured to slidably align or mate with the dovetail feature 1222 that extends from the posterior side of the washer sizer tool 1200. In use, the lateral mass decorticator guide 1300 may be translated or slide up and down the dovetail feature 1222 to help position the lateral mass decorticator guide 1300 in the desired location, and to indicate, using the washer size marker line 1204, which size facet screw assembly should be used.
In use, there is a distance or space 1312 formed between the lateral mass contacting surface 1306 of the lateral mass decorticator guide 1300 and the joint spacer 1206 of the washer sizer tool 1200. This distance or space 1312 helps determine the size of the facet screw assembly components, such as the length and size of the facet screw and the size of the washer implant 1400.
The intrafacet engagement portion 1418 of the second portion 1404 may also include teeth 1414 extending from either side. The teeth may be used to engage the intrafacet surfaces of a first or primary and adjacent vertebra.
The washer implant 1400 may also include a coupling member or feature to couple the washer to an implant delivery tool. In some examples, the coupling member is a threaded aperture 1408 that extends through a portion of the washer implant 1400, such as extending through the intrafacet engagement portion 1418.
In some examples, positioned between the threaded aperture 408 and the facet screw opening 1412 of the first portion 1402 is a keyway 1410. In some examples, the keyway 1410 is a groove 1410. The groove 1410 may be shaped to align or fit with a feature, such as a tongue or key feature, of the washer implant delivery tool (see
In some examples, the washer implant delivery tool 1600 includes a distal end with a facet screw guide 1612 and a proximal end with a washer release knob 1604. A shaft 1608 may extend between the facet screw guide 1612 and washer release knob 1604. Above the shaft and proximate to the washer release knob 1604 may be a shoulder 1622. In some examples, the shoulder 1622 may be cylindrically shaped and have a diameter that is larger than a diameter of the shaft 1608. In use, the shoulder 1622 may be used to align the washer implant delivery tool 1600 with the facet access guide 1100.
The shaft 1608 may include an upper portion 1616 and a lower portion 1618. Similar to the upper portion 1116 and lower portion 1118 of the facet access guide 1100, the upper portion 1616 and lower portion 1618 may be angled with respect to each other. The upper portion 1616 may be shaped to fit adjacent to or align with the posterior side of the upper portion 1116 of the facet access guide 1100. The lower portion 1618 may be shaped to fit adjacent to or align with the posterior side of the lower portion 1118 of the facet access guide 1100.
As can be understood from
The distal end of the washer implant delivery tool 1600 also includes a key feature 1610. In some examples, the key feature is a raised feature or a tongue 1610. In use, the tongue 1610 is configured to align with the keyway or groove 1410 of the washer implant 1400 to properly position the washer implant 1400 with the washer implant delivery tool 1600.
The distal end of the washer implant delivery tool 1600 also includes a facet screw guide 1612, including a facet screw portal 1614 extending through the facet screw guide 1612. The facet screw guide 1612 may be positioned at an angle with respect to the shaft 1608 and actuation rod 1602. When assembled with the washer implant 1400, the facet screw portal 1614 may be generally coaxial with the facet screw opening 1412 of the first portion 1402 and second portion 1404 of the washer implant 1400.
A post or pin 1620 may extend away from the facet screw guide 1612, in a lateral medial direction. The pin 1620 of washer implant delivery tool 1600 may be similar to the pin 1220 of washer sizer tool 1200. The pin 1620 may be used to align or locate the washer implant delivery tool 1600 with respect to the facet access guide 1100 when assembled or coupled together to deliver the facet screw assembly.
The head 1510 may also include a tool connector feature 1506, for example a keyway or being keyed to accept a hex, star, cross, or other type of tool key to rotate or manipulate the position of the facet screw 1500.
As shown in
Once the facet access guide 1100 is positioned properly with respect to the facet joint 1101, a user will separate or remove the impact handle 1102 from the facet access guide 1100. The user may then removably and/or slidably engage or assemble the washer sizer tool 1200 with the facet access guide 1100, so that the access guide interface 1202 of the washer sizer tool 1200 aligns with the instrument guide portal 1104 of the facet access guide 1100. A user may then remove or decouple the impact handle 1102 from impact handle connection 1107 of the facet access guide 1100 (see
After the washer sizer tool 1200 is initially assembled with the facet access guide 1100, the joint spacer 1206 may not be in the desired or proper positon within the facet joint. To move or adjust the position of the washer sizer tool 1200 so that the joint spacer 1206 is moved into position, a user would tamp or impact the impact handle 1102 coupled to the washer sizer tool 1200. The impact force on the impact handle 1102 would move or force the washer sizer tool 200 downwards with respect to the facet access guide 1100. The connection of the impact handle 1102 to the upper portion 1216 would provide alignment support for the washer sizer tool 200 with respect to the facet access guide 1100, and the pin 1220 would engage the ramp 1120 to provide further alignment and support. The trajectory of washer sizer tool 1200 is guided by the impact handle 1102 shaft and the instrument guide handle portal 1110, as well as the ramp 1120 and the pin 1220. With this, the distal end of the joint spacer 1206 may be properly placed in the facet joint.
Next, a user may determine the appropriate size facet screw assembly components, such as the washer implant 1400 and facet screw 1500, to use for the procedure.
In some instances, the lateral mass may be an uneven or contoured bone surface (i.e. bumpy, wavy, or generally not flat), and a user may want to flatten or even out the surface to help to size the washer implant 1400 appropriately. In some instances, the lateral mass may be generally flat, but the user may wish to decorticate the surface to help stimulate and improve bone growth around the area of the facet screw assembly.
Once the combination of the washer sizer tool 1200 and lateral mass decorticator guide 1300 have been used to determine the appropriately sized facet screw assembly components, a user may then detach the impact handle 1102 from the washer sizer tool 1200, and remove the washer sizer tool 1200 and lateral mass decorticator guide 1300.
The user will then impact the handle to advance the washer implant 1400 over the lateral mass of the first or primary vertebrae and into the facet joint. The instrument trajectory is guided by the shaft of the impact handle 1102 through the instrument guide handle portal 1110 and by the ramp 1120 and the pin 1620 of the washer implant delivery tool 1600.
Once the pilot hole is drilled, the user may then insert the appropriately sized facet screw 1500 through the facet screw portal 1614 and advance the screw 1500 there through. The facet screw portal 1614 guides the facet screw 1500 to the proper fixed angle trajectory across the washer implant 1400 and the facet joint. The tightening of the head 1510 of the facet screw 1500 with the threaded portion 1406 of first portion 1402 of the washer implant 1400 in combination with the threaded elongated shaft 1512 engaging with the first or primary vertebra helps to compress the facet joint.
To release the washer implant 1400 from the actuation rod 1602 of the washer implant delivery tool 1600, a user will remove the drill bit from the facet screw portal 1614. The user will then rotatably engage the washer release knob 1604, thereby rotating the actuation rod 1602. As the washer release knob 1604 is rotated, the distal end of the actuation rod 1602 will disengage or unscrew from the threaded aperture 1408 of the washer implant 1400. Once the actuation rod 1602 is disengaged, a user may remove both the washer implant delivery tool 1600 and the facet access guide 1100 from the surgical space, and the washer implant 1400 will remain in place. The process can then be repeated for another facet joint if needed.
In some examples, a method of delivering a facet screw assembly to a facet joint using a facet screw assembly delivery system may include placing a facet access guide, such as or similar to facet access guide 1100, into the facet joint. The method may include detachably or removably coupling a washer sizer tool, such as or similar to washer sizer tool 1200, with the facet access guide. In some examples, the washer sizer tool may be slidably coupled with the facet access guide. An impact handle may then be disconnected from the facet access guide and detachably coupled to the washer sizer tool. The impact handle may then be impact to position the washer sizer tool in an appropriate location with respect to the facet joint.
The method may also include coupling a lateral mass decorticator guide, such as or similar to lateral mass decorticator guide 1300, with the washer sizer tool. The lateral mass decorticator guide may be slid down a shaft of the washer sizer tool to be positioned adjacent or contact a lateral mass of the facet joint.
The method may include advancing a decorticator through a tool guide of the lateral mass decorticator guide and decorticating the lateral mass.
The method may include measuring, by the alignment of the lateral mass decorticator guide and the washer sizer tool, a recommended facet screw assembly size for the facet joint. In some examples, the facet screw assembly may include components that are the same or similar to the facet screw 1500 and washer 1400.
The method may include decoupling the lateral mass decorticator guide and washer sizer tool from the facet access guide. The method may then include selecting a washer size and coupling the washer to a washer implant delivery tool. The washer implant delivery tool may then be slidably coupled to the facet access guide, and the impact handle may be coupled to the washer implant delivery tool. The washer implant delivery tool may then be impacted to position the washer into the facet joint.
The method may then include drilling a pilot hole across the facet joint for the facet screw.
The method may then include advancing a facet screw through the pilot hole and placing the facet screw across the facet joint. The method may include tightening the screw onto the washer and compressing the facet joint.
The method may then include decoupling the washer implant delivery tool from the facet screw assembly. The method may then include removing the washer implant delivery tool and facet access guide from the facet joint.
In some embodiments, the diameter of the trans-facet threaded aperture 2108 and corresponding trans-facet screw 2104 (
As shown in
In some examples the implant 2400 includes a facet screw 2402, an expandable spacer 2404, and a compression nut 2406. As shown in
When assembled, the expandable spacer 2404 may be coupled to the facet screw 2402 as to help prevent rotational movement of the spacer relative to the screw 2402. In some examples, the spacer 2404 may be welded or keyed to the screw 2402. The expandable spacer 2404 may be generally cylinder shaped or cylindrical, with an inner diameter that is larger or greater than the shaft diameter of the facet screw 2402. This may allow the spacer 2404 to slide along the shaft of the facet screw 2402 and abut the threaded end 2408, such as in the configuration shown in
In use, such as in the deployed position or configuration shown in
In use, as shown in
As shown in
As shown in
Details of the screw 2602 and screw expander 2604 are shown in
As shown in
Details of the engagement between the implant 2600 and the screw driver 2702 are shown in
As is also shown in
As shown in
As shown in
In use, an incision is made in the posterior spine, such as the cervical, thoracic, and/or lumbar spine and manual dissection performed down to the surgical area, such as a cervical, thoracic, and/or lumbar facet joints. In an intra-facet scenario, the facet joint is accessed with an access chisel and a guide tube is placed. The surgical site is prepared using an awl and chisel rasp. As can be understood from
In some examples, the same implantation technique for intra-facet and trans-facet may be used with the implant 3000 and delivery device 3100. Similar to the implant 2800 and delivery device 2900, the implant 3000 is loaded onto the screw driver 3102. In the assembly of implant 3000 and delivery device 3100, a friction fit may be used as a holding mechanism for the screw 3002. In some embodiments, the same screw holding mechanism described with respect to implant 2600 and delivery device 2700 could be applied.
Once the screw 3002 of the implant 3000 is properly implanted, the locking collar 3105 is removed from the screw driver 3102, as shown in
As shown in
All relative and directional references (including: upper, lower, upward, downward, left, right, leftward, rightward, top, bottom, side, above, below, front, middle, back, vertical, horizontal, and so forth) are given by way of example to aid the reader's understanding of the particular embodiments described herein. They should not be read to be requirements or limitations, particularly as to the position, orientation, or use unless specifically set forth in the claims. Connection references (e.g., attached, coupled, connected, joined, and the like) are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements. As such, connection references do not necessarily infer that two elements are directly connected and in fixed relation to each other unless specifically set forth in the claims.
Those skilled in the art will appreciate that the presently disclosed embodiments teach by way of example and not by limitation. Therefore, the matter contained in the above description or shown in the accompanying drawings should be interpreted as illustrative and not in a limiting sense. Thus, it is intended that the scope of the present disclosure should not be limited by the particular embodiments described above. Changes in detail or structure may be made without departing from the spirit of the invention as defined in the appended claims. In methodologies directly or indirectly set forth herein, various steps and operations are described in one possible order of operation, but those skilled in the art will recognize that steps and operations may be rearranged, replaced, or eliminated without necessarily departing from the spirit and scope of the present invention as claimed below.
This application is a U.S. National Stage Patent Application of International Patent Application No. PCT/US2019/012367, filed Jan. 4, 2019, which is related to and claims priority to U.S. Pat. Appl. No. 62/613,547 filed on Jan. 4, 2018; U.S. Pat. Appl. No. 62/667,951 filed on May 7, 2018; and U.S. Pat. Appl. No. 62/734,568 filed on Sep. 21, 2018; all of which are hereby incorporated by reference herein for any purpose.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2019/012367 | 1/4/2019 | WO |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2019/136263 | 7/11/2019 | WO | A |
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