Vertebral Body Replacement and Insertion Devices

Abstract

Disclosed herein is an expandable interbody device having a modular end plate. The expandable interbody device includes an outer column, an inner column threadedly coupled to the outer column and translatable relative to the outer column along a longitudinal axis, and a tension ring for adjusting the body length of the expandable interbody device. The tension ring has a plurality of teeth, and the outer column has at least one arm for engaging with one of the teeth to lock the tension ring. The inner column and / or the outer column can include a connector for connecting to a modular end plate having a substantially hollow core. The modular end plate includes a plate with a set screw trapped therein. The modular end plate has an opening for receiving the connector of the inner and / or outer column.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to spinal implants, specialized tools for inserting spinal implants, and surgical methods for replacing portions of vertebral bodies of the spine.

[0002] Fusion cages, as well as other types of interbody instruments and devices, are frequently utilized in spinal surgery within the vertebrae or in the intervertebral disc space (interbody) between the respective vertebrae. In an interbody device, one or more such spinal bodies are placed between the vertebrae to provide support and promote fusion between adjacent vertebrae. Such fusion may be necessary due to disease, injury, general deterioration, or congenital problems.

[0003] The goal of most spine surgeries is to minimize the trauma of the surgery itself. One way to minimize trauma is to create the smallest possible access port to reach the surgical site; however, a small access port limits the size of tools and implants that can pass through the access port.

[0004] However, some interbody devices are now being made that are expandable. The expandable interbody devices are initially smaller than traditional non-expandable (fixed) interbody devices so that the expandable interbody device can be more easily inserted and / or implanted into the disc space. Once positioned within the disc space, the expandable interbody device is expanded to a desired size to achieve the amount of expansion needed for a particular patient. Summary of the Invention

[0005] The present disclosure relates to an expandable interbody device that can be inserted into an intervertebral disc space in a collapsed state to minimize surgical trauma to the patient and then expanded to achieve a desired lordosis. The interbody device includes an inner column and an outer column that are vertically translatable relative to one another via an expansion ring connected to the outer column.

[0006] Rotation of the tension ring causes the outer and inner columns to move in opposite directions along their central axes, thereby causing vertical tensioning of the tension body.

[0007] In some embodiments, the tension ring includes radially extending teeth that engage with the locking arms of the outer column. The tension ring cannot rotate until the locking arms of the outer column are pushed radially outward. In some embodiments, the insertion / extension tool includes protrusions or arms that can push the locking arms of the outer column radially outward to allow rotation of the tension ring.

[0008] According to another aspect, the modular endplate includes a substantially hollow lumen with a set screw trapped within the plate.

[0009] According to another aspect, a method for positioning and expanding an interbody device is provided. [Brief explanation of the drawings]

[0010] The embodiments set forth in the drawings are exemplary and illustrative in nature and are not intended to limit the subject matter defined by the claims. The following detailed description of exemplary embodiments can be better understood when read in conjunction with the following drawings, in which like structure is indicated with like reference numerals and in which:

[0011] [Figure 1] FIG. 1 is an exploded perspective view of an expandable interbody device in accordance with the present disclosure; [Figure 2] FIG. 2 is a perspective view of the embodiment shown in FIG. [Figure 3] 3 is a perspective view of the embodiment shown in FIG. 2 with the expandable interbody device in an extended position. [Figure 4] FIG. 10 is a top perspective view of an outer column of an expandable interbody device. [Figure 5] FIG. 5 is a cross-sectional view of the outer column shown in FIG. 4. [Figure 6] FIG. 10 illustrates another top perspective view of the outer column of the expandable interbody device. [Figure 7] FIG. 7 is a cross-sectional view of the outer column shown in FIG. 6. [Figure 8] FIG. 8 is a perspective view of a portion of the outer column shown in FIGS. 4 to 7. [Figure 9] FIG. 10 is a front view of the outer column. [Figure 10] FIG. 1 is a perspective view of an expandable interbody device. [Figure 11] 11 is a cross-sectional view of the expandable interbody device of FIG. 10. [Figure 12] FIG. 12 is a top perspective view of the expandable interbody device of FIGS. 10-11. [Figure 13] FIG. 13 is a cross-sectional view of FIG. 12. [Figure 14] FIG. 12 is a perspective view of an extension ring of an extension interbody device. [Figure 15] FIG. 15 is a cross-sectional view of FIG. [Figure 16] FIG. 12 is a perspective view of a medial column of an expandable interbody device. [Figure 17] 17 is another perspective view of the medial column of the expandable interbody device of FIG. 16. [Figure 18] FIG. 12 is a perspective view of a modular end plate of an expandable interbody device. [Figure 19] FIG. 19 is a cross-sectional view of FIG. 18. [Figure 20] FIG. 16 is a top view of an expandable interbody device with modular end plates. [Figure 21] FIG. 21 is a top view of an alternative arrangement of modular end plates of the expandable interbody device of FIG. 20. [Figure 22] FIG. 22 is a top view of an alternative arrangement of modular endplates of the expandable interbody device of FIGS. 20-21. [Figure 23] FIG. 10 is a perspective view of another modular end plate. [Figure 24] FIG. 1 is a perspective view of an insertion / extension tool. [Figure 25] FIG. 10 is a perspective view of the distal end of the insertion / tensioning tool as it approaches the expandable interbody device. [Figure 26] FIG. 12 is a side view of an interbody device connected to an insertion / tensioning tool. [Figure 27]FIG. 26 is a side cross-sectional view of the interbody device connected to the insertion / tensioning tool of FIG. 25, with the interbody device in a retracted position. [Figure 28] FIG. 26 is a side cross-sectional view of the interbody device connected to the insertion / extension tool of FIG. 25, with the interbody device in an extended position. [Figure 29] FIG. 10 is a perspective view of the proximal end of the insertion / extension tool. [Figure 30] FIG. 10 is another perspective view of the proximal end of the insertion / extension tool. DETAILED DESCRIPTION OF THE INVENTION

[0012] The present disclosure relates to an expandable interbody device for use in implantation between a first vertebra and a second vertebra, which is inserted into a space left by the removal of at least a portion of one or more vertebrae to maintain a desired spacing between the remaining vertebrae while providing support, stabilization, and / or promotion of bone growth between the first and second vertebrae.

[0013] 1-3 illustrate one embodiment of an expandable interbody device or vertebral body replacement device 100. The exploded view of FIG. 1 shows that the expandable interbody device 100 includes an outer column 105, an externally threaded inner column 110, and a tension ring 115. The inner column 110 is threadedly coupled to the outer column 105 and is movable relative to the outer column 105 along a longitudinal axis. The tension ring 115 may be secured to the outer column 105 via a cap 120 to allow longitudinal adjustment of the expandable interbody device. In some embodiments, a set screw 130 can be used to lock the inner and outer columns in place relative to one another.

[0014] Figure 2 shows a perspective view of expandable interbody device 100 in a non-extended or folded state, and Figure 3 shows a perspective view of expandable interbody device 100 in an extended or distracted state. Expandable interbody device 100 is configured to extend along its longitudinal axis from a first end to a second end. Tension ring 115 is secured to a first end of outer column 105 and is rotatable about the longitudinal axis to adjust the position of the outer column relative to the inner column, such that rotating tension ring 115 translates the inner column above or from the inside out of outer column 105, increasing the body length of the expandable body.

[0015] Outer column 105, inner column 110, and extension ring 115 can each have a hollow interior portion to allow bone growth inducing or promoting material to be inserted into and at least partially pass through expandable interbody device 100, potentially contacting and interacting with the bony surfaces of the upper and lower vertebral bodies. In some embodiments, interbody device 100 includes a porous material through which the bone growth promoting material can pass. Such a porous material may also allow bone growth into interbody device 100. In some embodiments, as described in more detail below, interbody device 100 can achieve new bone ingrowth instead of or in addition to achieving through-growth.

[0016] 4-8, the outer column 105 includes a first end 135, a second end 140, and a wall 145 extending from the first end 135 to the second end 140. The wall 145 defines an internal, substantially hollow lumen 147 extending axially through the outer column 105. The outer column 105 may be substantially hollow to receive the inner column 110 and / or to provide a space for inserting a material that induces or promotes bone growth. Similarly, one or more openings 150 may be provided to provide a space for inserting a material that induces or promotes bone growth and promotes new bone growth between the remaining vertebrae.

[0017] The outer column wall 145 includes one or more arms 155 for engaging teeth or protrusions on the tension ring 115, as described in more detail below. In some configurations, the outer column 105 includes one arm 155. In other configurations, the outer column 105 includes two arms 155 or more. In a particular configuration, the outer column 105 includes two arms 155, with a first arm 155a on a first side of the outer column 105 and a second arm 155b on a second, opposite side of the outer column 105.

[0018] In one embodiment, the arms 155 of the outer column 105 are biased into a position where the arms engage the tension ring 115. To disengage the arms 155 from the tension ring 115, the arms 155 must be positioned outwardly away from the tension ring 115. In this embodiment, the outer column 105 has a first, locked configuration in which the tension ring 115 cannot move relative to the outer column, and a second, unlocked configuration in which the arms are extended outward and the tension ring 115 can rotate relative to the outer column 105.

[0019] The arms 155 may be integrally formed with the outer column 105, or they may be attached to or otherwise secured to the outer column 105. In one configuration, the first arm 155a and the second arm 155b are integrally formed with the outer column 105 by slots 160 cut out of the wall 145 of the outer column. By cutting the slots 160 in the wall 145, the remaining portion of the wall 145 extending between the slots 160 can form the arms 155. Depending on the desired locking action of the arms 155, the arms 155 can be of any suitable length and / or width desired.

[0020] 8, a specific embodiment of arm 155 is shown. Arm 155 includes an inwardly extending protrusion 162 for engaging one of a plurality of radial teeth on the tension ring. Inwardly extending protrusion 162 also functions as a pawl to prevent movement of tension ring 115 unless a pawl on arm 155 is actively pushed out.

[0021] The arms 155 and / or walls 145 of the outer column 105 can have one or more alignment features therein for interfacing with mating alignment features on an extension and / or insertion tool. For example, the arms 155 can have a sloped or angled front surface 164. The front surface 165 of the outer column 105 can have a similarly shaped notch 170 such that the notch 170 on the front surface of the outer column 105 and the sloped surface 164 on the front side of the arms 155 together form a slot. This slot can allow an extension tool to be inserted and push the arms 155 radially outward, as described in more detail below.

[0022] Similarly, the outer column 105 can have an opening 175 for receiving a tensioning tool. In one configuration, the opening 175 extends through the front surface 165 of the outer column 105 and is threadable to allow the tensioning tool to be threaded into the front surface 165 of the outer column 105. The opening can be sized for insertion of the tensioning tool. Additional slots, such as slots 180, recesses, protrusions, or other alignment features, can be formed in the outer column 105 to interface with and align the tensioning tool. A void or opening 178 through the outer column 105 can allow a set screw to pass through to frictionally fit the outer column 105 to the inner column 110.

[0023] The tension ring 115 can be secured to the outer column 105 in any suitable manner. The tension ring 115 can be connected to the outer column 105 at any desired point, and in one embodiment, the tension ring 115 is secured to the outer column 105 at or proximal to the second end 140 of the outer column 105.

[0024] The outer column 105 may also include a connector 186 (FIG. 9) for connecting to an end plate on the lower side (i.e., first end 135 of the outer column 105) of the interbody device 100. The connector 186 may be any suitable connector known for attaching various end plates to the outer column 105. In other configurations, no connector is provided for the end plate.

[0025] In one embodiment, connector 186 is a threaded connector that allows a set screw for the end plate to thread into first end 135 of outer column 105. Alternatively, the connector may include facets 188. As described in more detail below, the end plate may have openings that receive the sinusoidal facets 188 of the connector.

[0026] 10-15, tension ring 115 and associated cap 120 are connected to outer column 105 to allow tension ring 115 to rotate about the longitudinal axis of vertebral body replacement device or expandable interbody device 100 to adjust the position of outer column 105 relative to inner column 110 and thereby adjust the body length of expandable interbody device 100. Body length is adjusted without rotating inner column 110 or outer column 105 (i.e., inner column 110 and outer column 105 translate relative to one another).

[0027] In one embodiment, the cap 120 can secure the tension ring 115 to the outer column 105. As discussed above, the cap 120 can be attached to the outer column 105 in any suitable manner. Other suitable connections can also be used to secure the tension ring 115 to the outer column 105.

[0028] The tension ring 115 is internally threaded to mate with the internal threads of the inner column 110, as best seen in the cross-sectional view of Figure 11. The internal threads 195 of the tension ring 115 engage with the external threads 200 of the inner column 110. Rotation of the tension ring 115 linearly translates the inner column 110 along its central axis relative to the outer column 105.

[0029] The tension ring 115 also includes at least one radially extending tooth 210 for engaging with the arm 155 on the outer column 105. In one embodiment, the tension ring comprises a plurality of radially extending teeth 210. The radially extending teeth 210 may form a pawl or a gear that is held in place by the arm 155. The tension ring 115 is unable to rotate, or is restricted from rotating, unless the arm 155 is actively extended outward to disengage the radially extending tooth 210.

[0030] The tension ring 115 may also include means for allowing a tensioning tool to rotate the tension ring 115. In some embodiments, the tension ring 115 includes a plurality of longitudinally extending teeth 215 for engaging a tensioning and / or insertion tool. The tool may be inserted through an opening (such as opening 175) in the outer column 105 to engage the longitudinally extending teeth, as described in more detail below.

[0031] The inner column includes a first end 220 and a second end 225, with an elongated body 230 extending from the first end 220 to the second end 225. The inner column 110 generally defines a hollow interior extending axially therethrough. The hollow interior of the inner column 110 also allows for additional bone growth promoting material to be placed within the expandable interbody device 100 to encourage new bone formation through the expandable interbody device 100.

[0032] The inner column 110 includes an externally threaded portion and includes external threads 200 that mate with the internal threads 195 of the tension ring 115 .

[0033] The inner column 110 may also have a flat or substantially flat, non-threaded portion 240 along at least a portion of the inner column 110. The flat, non-threaded portion 240 may allow the set screw 130 to lock the inner column 110 in position relative to the outer column 105. The set screw 130 may thread through a void or opening 178 in the outer column 105 and into the flat, non-threaded portion 240 of the inner column 110.

[0034] The medial column 110 may also include a connector 245 for connecting to an end plate on the upper side (i.e., the first end 220 of the medial column 110) of the interbody device 100. The connector 245 may be any suitable connector known for attaching various end plates to the medial column 110. In other configurations, no connector is provided for the end plate.

[0035] In one embodiment, connector 245 is a threaded connector that allows a set screw for the end plate to thread into first end 220 of inner column 110. Alternatively, the connector may include sinusoidal facets 250. As described in more detail below, the end plate may have openings that receive sinusoidal facets 250 of connector 245. The threaded connector may be integrally formed with inner column 110, or in other embodiments, the threaded connector may be attached to inner column 110.

[0036] According to another aspect of the present disclosure, a method of endplate modularization and the ability to provide graft openings through the endplate is described. Figures 18-19 illustrate one embodiment of an annular endplate 260. In some embodiments, the endplate 260 defines a central lumen 265. The central lumen 265 can allow a surgeon to pack a bone growth-inducing or promoting material, allowing bone communication through the endplate 260 and promoting new bone growth between the remaining vertebrae. The endplate comprises a plate 270 and a set screw 275 trapped within the plate 270 between two inwardly extending projections (an inner annular ridge 280 and an inner rim 285).

[0037] The inner annular ridge 280 includes a pattern that is mateable with a pattern provided on one or more of the outer end 135 of the outer column 105 and / or the outer end 220 of the inner column 110. In other words, the annular ridge 280 of the plate forms an opening having an inner diameter shaped to receive the threaded connector on the outer end 135 of the outer column 105 and / or the outer end 220 of the inner column 110.

[0038] In certain configurations, a pattern on the inner annular ridge 280 of the plate 270 mates with a pattern on the outer column 105 and / or inner column 110. The annular ridge 280 of the plate 270 forms an opening with an inner diameter, and the opening is shaped to receive the outer column 105 and / or inner column 110. Any pattern or geometric shape can be used. A pattern with 16 projections or facets allows for 16 different positions or geometries in which the plate 270 can be positioned relative to the outer column 105 and / or inner column 110. Patterns with fewer projections can allow for fewer unique positioning of the plate 270 relative to the outer column 105 or inner column 110. FIGS. 20-22 illustrate an embodiment of an end plate with six facets, illustrating three different relative positioning of the end plate relative to the telescoping interbody device 100.

[0039] After the endplate 260 is placed over the patterned portion of the medial column 110 or lateral column 105, with the geometry of the endplate's inner annular ridge 280 matching the geometry of the patterned portion of the medial column 110 or lateral column 105, the set screw 275 can be turned to lock the endplate 260 in place on the end of the interbody device 100. The set screw 275 includes an inner portion 287 that can mate with the patterned portion of the medial column 110 or lateral column 105. The set screw 275 also includes an outer end that has a shape that can mate with an inserter device to turn the set screw within the endplate. Confining the set screw 275 within the plate 270 can simplify the process for placing the endplate 260 and can prevent the set screw 275 from coming free or otherwise falling out of the plate 270.

[0040] Various endplate shapes are possible. Figures 20-23 show several endplate embodiments. Circular, oval, elliptical, kidney bean, polygonal, geometric, or banana shapes are possible. Because the patterned portions on both ends of the interbody device are independent, different types of endplates can be used on each end of the interbody device. This also allows the surgeon to adjust the lordosis on both ends of the interbody device 100 to improve interbody device placement.

[0041] The endplates can be configured to engage portions of the vertebrae in a predetermined orientation to maximize bone contact with the top or outer surface of the endplate. The endplates can be formed with a single thickness or with thicknesses that vary from a gradual increase in height from anterior to posterior to mimic the natural curvature of the spine. In one particular embodiment, the endplates can have an approximately banana shape and a tapered thickness to provide a banana endplate for kyphosis.

[0042] The end plates can be formed of any suitable material. In some embodiments, the end plates 260 are formed from porous titanium and / or solid titanium. For example, the upper or outer side of the end plate can be formed from porous titanium and the lower side can be formed from solid titanium according to known methods (e.g., those described in U.S. Patent Application Publication No. 2022 / 0087819). In other embodiments, a porosity gradient can be used.

[0043] According to another aspect, the present disclosure includes a system for use of an expandable interbody device, the system including an insertion and / or extension tool. In some embodiments, separate tools can be used for insertion and extension. In other embodiments, a combination insertion / extension tool can be used for both inserting the expandable interbody device 100 and extending the expandable interbody device 100.

[0044] 24-28, the insertion / extension tool 300 has a proximal end 305 with a removable handle portion 310 and a distal end 315 for interfacing with the expandable interbody device 100. The distal end 315 includes one or more arms 320 that can be inserted into the slots 170, 180 of the outer column 105. When the arms 320 of the insertion / extension tool 300 engage the arms 155 of the outer column 105, the angled surfaces of the arms 155 allow the arms 320 of the insertion / extension tool to push the arms 155 radially outward.

[0045] The distal end 315 of the insertion / tensioning tool 300 can also include a molded driver 325, threads 330, and a guide hole 335. The threads 330 can thread into the threaded opening 175 on the front surface of the outer column 105 to removably attach the distal end 315 of the insertion / tensioning tool 300 to the extension interbody device 100. The driver 325 can interface with the longitudinally extending teeth 215 of the tension ring 115 to rotate the tension ring. The guide hole 335 can be used to guide the drive mechanism to insert the set screw 130.

[0046] The insertion / tensioning tool may also be provided with features such as modular / interchangeable handles, additional handles for applying torque, and / or a removable end for impaction. The removable handle portion 310 allows the surgeon to apply force to the end of the tool and directly to the front of the expandable interbody device 100. That is, the force applied to the end of the insertion / tensioning tool for impaction does not impart force to other gears or the like on the insertion / tensioning tool.

[0047] In some embodiments, the insertion / tensioning tool can provide the surgeon with an audible indication of the extension of the interbody device 100 by the insertion / tensioning tool. In one embodiment, a first fixed ramp 340 is connected to the tool by a second ramp 345 that rotates relative to the first ramp 340. The second ramp 345 can rotate in conjunction with the driver 325. The second ramp 345 can be configured to rotate with the driver (extending the extendable interbody device 100) such that a particular extension interval of the interbody device results in one full rotation of the second ramp 345 (i.e., 1 mm of extension equals one rotation of the second ramp 345). Each time the second ramp 345 completes a full rotation, the second ramp 345 slides backward relative to the first ramp 340, emitting an audible click. This audible click provides a clinically advantageous indication to the surgeon that the extendable interbody device is extending. Figure 29 shows the second ramp 345 rotating relative to the first fixed ramp 340, and Figure 30 shows the second ramp 345 as it slides back, producing the audible click.

[0048] In use, the expandable interbody device may be surgically implanted into a patient using any number of suitable methods. In some embodiments, a method of implanting the expandable interbody device 100 includes engaging the distal end 315 of the insertion / tensioning tool 300 with the anterior surface of the lateral column 105. With the inserter insertion / tensioning tool 300 engaged with the interbody device 100, the interbody device 100 is positioned in the disc space and positioned as desired. Positioning the interbody device 100 in the desired location can be accomplished using fluoroscopy. To this end, one or more of the components of the interbody device 100 may be at least partially radiopaque. In some embodiments, the interbody device 100 includes one or more radiopaque markers whose primary purpose is to assist in proper positioning of the interbody device 100 in the disc space. In some embodiments, the insertion / tensioning tool does not engage the expandable interbody device 100 until the expandable interbody device 100 is properly positioned in the disc space. In embodiments in which the interbody device 100 is connected to the insertion / tensioning tool 300 prior to insertion, the proximal end 305 of the insertion / tensioning tool 300 can be configured to receive and withstand hammer blows that may be required to properly position the expandable interbody device 100.

[0049] With the interbody device 100 properly positioned, the insertion / tensioning tool is rotated to rotate the tension ring 115 and translate the lateral column 105 and medial column 110 relative to one another. The tensioning interbody device 100 is tensioned by continuing to rotate the insertion / tensioning tool 300 until the desired amount of tension is achieved. The amount of tension can be observed using the tension indicator or by using fluoroscopy.

[0050] Once the desired amount of extension is achieved, the insertion / extension tool 300 is removed from the extension interbody device 100. Once the insertion / extension tool 300 is removed, the arms 155 of the outer column 105 return to their biased position and engage the radially extending teeth of the extension ring 115, locking the extension ring 115 in place. The outer column 105 and inner column 110 can be further locked in place by using a set screw 130. In some embodiments, biologics or materials that promote bone growth are then injected into the interbody device 100 by injecting them through the cannulated structure of the insertion / extension tool 300.

[0051] It will be appreciated that the expandable interbody device 100 can be used in spinal surgery in any portion of the spine, including the cervical, thoracic, and / or lumbar spine. To accommodate various portions of the spine, the expandable interbody device 100 can be formed in different sizes. For example, Figures 1-3 illustrate one embodiment of a cervical device. Figures 26-28 illustrate an embodiment of a thoracic-lumbar device.

[0052] Embodiment The following embodiments are provided merely as examples of specific configurations, materials, arrangements, etc., contemplated by the authors of the present disclosure. Embodiment 1. 1. A vertebral body replacement device dimensioned to be implanted between a first vertebra and a second vertebra, comprising: an extendable body configured to extend from a first end to a second end along a longitudinal axis, the extendable body having an outer column, an inner column threadedly coupled to the outer column and translatable relative to the outer column along the longitudinal axis, and an extension ring; an extension ring rotatable about a longitudinal axis to translate the outer column relative to the inner column to adjust a body length of the extension body, the extension ring including a plurality of radially extending teeth for engaging the arms of the outer column and a plurality of teeth for engaging an inserter device; the outer column includes arms for engaging teeth of a plurality of radially extending teeth of the tension ring; A vertebral body replacement device, wherein the arms of the outer column have a first locking configuration in which the extension ring cannot move relative to the outer column, and a second unlocking configuration in which the arms are extended outward to disengage teeth of a plurality of radially extending teeth, allowing the extension ring to rotate relative to the outer column. Embodiment 2. A vertebral body replacement device as described in embodiment 1, wherein the outer column has a first arm for engaging with a first tooth portion of the plurality of radially extending teeth portion of the tension ring, and the outer column further has a second arm for engaging with a second tooth portion of the plurality of radially extending teeth portion of the tension ring. Embodiment 3. 3. The vertebral body replacement device of embodiment 2, wherein the second arm is on an opposite side of the lateral column from the first arm. Embodiment 4. 4. The vertebral body replacement device of embodiment 3, wherein the first and second arms are configured to be mirror images of each other. Embodiment 5. 5. The vertebral body replacement device of any one of embodiments 1 to 4, wherein the outer column has a first end and a second end, and the wall of the outer column extends from the first end to the second end. Embodiment 6. 6. The vertebral body replacement device of any one of embodiments 2-5, wherein the first arm and the second arm are integrally formed with the outer column by slots cut from the wall of the outer column. Embodiment 7. 7. The vertebral body replacement device according to any one of embodiments 2 to 6, wherein the first arm and the second arm comprise inwardly facing sloped surfaces. Embodiment 8. A vertebral body replacement device as described in any one of embodiments 2 to 7, wherein the first arm and the second arm have inwardly extending protrusions for engaging with teeth among a plurality of radially extending teeth on the extension ring. Embodiment 9. 8. The vertebral body replacement device of any one of embodiments 2-7, wherein the extendable body comprises a first endplate at a first end and a second endplate at a second end. Embodiment 10. 10. The vertebral body replacement device of embodiment 9, wherein the first and second end plates independently have one of the following shapes: square, circular, rectangular, oval, and kidney bean.

[0053] Embodiment 11. 11. The vertebral body replacement device of any one of embodiments 9 and 10, wherein at least one end plate is modular and connectable to the first or second end. Embodiment 12. 12. The vertebral body replacement device of embodiment 11, wherein at least one end plate is configured to connect the first or second end at two or more angles relative to the vertebral body replacement device. Embodiment 13. 11. The vertebral body replacement device of any one of embodiments 9 and 10, wherein at least one of the first and second end plates is integral with the medial column or the lateral column, respectively. Embodiment 14. a connector at a first end of the inner column for attachment to the end plate, the connector comprising a facet; an end plate comprising a set screw and a plate, the set screw being trapped within the plate between an inner annular ridge and an inner rim; Equipped with 9. The vertebral body replacement device according to any one of embodiments 1 to 8, wherein the end plate is connectable to the medial column. Embodiment 15. 15. The vertebral body replacement device of embodiment 14, wherein the facets are sinusoidal. Embodiment 16. A vertebral body replacement device as described in any one of embodiments 14 and 15, wherein the inner annular ridge of the plate forms an opening with an inner diameter pattern, the opening receives a facet of the connector of the outer column, and the inner diameter pattern of the set screw is connectable to the facet of the connector of the outer column. Embodiment 17. a connector at a first end of the inner column having a facet for attachment to a set screw of the end plate; 1. An end plate comprising a set screw and a plate, the set screw being trapped within the plate between an inner annular ridge and an inner rim, the set screw having an internal pattern; Equipped with 17. The vertebral body replacement device according to any one of embodiments 1 to 16, wherein the endplate is connectable to the medial column. Embodiment 18. 17. The vertebral body replacement device of embodiment 16, wherein the inner annular ridge of the plate forms an opening having an inner pattern, the opening is configured to receive a facet of the connector of the outer column, and the inner pattern of the set screw is configured to engage with the facet of the connector of the outer column. Embodiment 19. an extendable body configured to extend from a first end to a second end along a longitudinal axis, the extendable body having an outer column, an inner column threadedly coupled to the outer column and movable relative to the outer column along the longitudinal axis, and an extension ring; the tension ring is rotatable about the longitudinal axis to adjust the relative position of the outer column with respect to the inner column to adjust the body length of the extendable body, the tension ring having a passive lock; the outer column has an arm for engaging a passive lock on the tension ring; Extendable interbody device. Embodiment 20. an extendable body configured to extend along a longitudinal axis from a first end to a second end; an end plate with a set screw and a plate; Equipped with an extendable body having an outer column, an inner column threadedly coupled to the outer column and translatable relative to the outer column along a longitudinal axis, and an extension ring; an extension ring rotatable about the longitudinal axis to translate the outer column relative to the inner column to adjust the body length of the extension body; an outer column having a first end and a second end, the first end having a connector for attachment to a set screw of the end plate; a set screw is trapped within the plate between the inner annular ridge and the inner rim; An end plate is connectable to the outer column; Vertebral body replacement system.

[0054] Embodiment 21. an extendable body configured to extend along a longitudinal axis from a first end to a second end; an end plate with a set screw and a plate; Equipped with an extendable body having an outer column, an inner column threadedly coupled to the outer column and translatable relative to the outer column along a longitudinal axis, and an extension ring; an extension ring rotatable about the longitudinal axis to translate the outer column relative to the inner column to adjust the body length of the extension body; an inner column having a first end and a second end, the first end having a connector for attachment to a set screw of the end plate; a set screw is trapped within the plate between the inner annular ridge and the inner rim; An end plate is connectable to the inner column; Vertebral body replacement system. Embodiment 22. A vertebral body replacement system as described in embodiment 20 or embodiment 21, wherein the inner annular ridge of the plate forms an opening with an inner diameter, the opening receives a facet of the connector of the outer column, and the set screw is configured to engage with the connector of the outer column. Embodiment 23. 23. The vertebral body replacement system according to any one of embodiments 20 to 22, further comprising a passive locking mechanism. Embodiment 24. the passive locking mechanism includes an extension ring, the extension ring including a plurality of radially extending teeth for engaging the arms of the outer column and a plurality of teeth for engaging the inserter device; the outer column includes arms for engaging teeth of a plurality of radially extending teeth of the tension ring; 24. The vertebral body replacement system of embodiment 23, wherein the arms of the outer column have a first locking configuration in which the extension ring cannot move relative to the outer column, and a second unlocking configuration in which the arms are extended outward and disengaged from the plurality of radially extending teeth, allowing the extension ring to rotate relative to the outer column. Embodiment 25. A vertebral body replacement device as described in any one of embodiments 1 to 18, an expandable interbody device as described in embodiment 19, or a vertebral body replacement system as described in any one of embodiments 20 to 24, wherein the outer column further comprises an opening configured to provide access to the inserter-engagement teeth of the expansion ring. Embodiment 26. 26. The vertebral body replacement device, expandable interbody device, or vertebral body replacement system of embodiment 25, wherein the opening comprises a threaded surface. Embodiment 27. an inserter, an elongated portion having a proximal end and a distal end, the elongated portion defining an axis and having a lumen opening at the proximal end and the distal end; a handle located at a proximal end of the elongated portion, the handle configured to be rotatable relative to the elongated portion; an engagement portion located at a distal end of the elongated portion; an elongated portion having a distal end, the elongated portion having a movable end positioned within the lumen, the elongated portion being configured to be mechanically connectable to the handle; Equipped with the engaging portion includes a first pair of extensions extending distally along the axis of the elongated portion, the first pair of extensions configured to disengage the passive locking mechanism when the inserter is connected to the expandable interbody device; Inserter. Embodiment 28. An inserter as described in embodiment 27, further comprising an engagement driver positioned within the lumen having an operable end extending at least partially from the distal end of the elongated portion, the engagement driver configured to be mechanically connectable to the handle. Embodiment 29. 29. An inserter as described in embodiment 28, wherein the engagement driver comprises a lumen within which the extension driver is positioned. Embodiment 30. An inserter described in any one of embodiments 27 to 29, wherein the operable end of the tension driver has a plurality of radial extensions configured to engage with the teeth of the tension ring of the tensionable interbody device.

[0055] Embodiment 31. An inserter according to any one of embodiments 28 to 30, wherein the operable end of the engagement driver has a threaded surface configured to threadably engage with a threaded opening in the expandable interbody device. Embodiment 33. An inserter described in any one of embodiments 27 to 32, further comprising a driver guide positioned at or near the distal end of the elongated portion, the driver guide defining an axis parallel to the axis of the elongated portion. Embodiment 34. 34. A method of using the inserter of any one of embodiments 27-33 with an expandable interbody device, comprising: advancing first and / or second pairs of extensions to be positioned on either side of the interbody device; and Rotating the handle to rotate the engagement driver, thereby threading the operable end of the engagement driver into the threaded opening of the interbody device. and securing the inserter to the interbody device by positioning the interbody device at a desired location within the patient's spine using an inserter; rotating the tension driver by rotating the handle, thereby causing tension of the interbody device as the operable end of the tension driver rotates a tension ring within the interbody device to translate two columns within the interbody device relative to one another; when the desired position and extension is achieved, rotating the engagement driver by rotating the handle, thereby disengaging the operable end of the engagement driver from the threaded opening of the interbody device; moving the inserter proximally away from the interbody device, leaving the interbody device in the desired position; A method comprising: Embodiment 35. 35. The method of embodiment 34, further comprising selecting an appropriate endplate based on size and shape to be secured to one or both ends of the interbody device. Embodiment 36. 36. The method of embodiment 35, wherein fixing the one or two end plates comprises selecting a desired orientation of one or both end plates relative to the interbody device and fixing one or both end plates in that orientation. Embodiment 37. 37. The method of any one of embodiments 34 to 36, further comprising engaging a set screw of the interbody device to lock the interbody device at a desired extension level, wherein engaging the set screw comprises inserting a driver through a driver guide to reach the set screw, the driver guide being located near the distal end of the elongated portion of the inserter. Embodiment 38. 38. The method of any one of embodiments 34-37, wherein the first and / or second pair of extension members are advanced to be positioned on either side of the interbody device, thereby disengaging a passive locking mechanism of the interbody device and thereby allowing extension and / or compression of the interbody device. Embodiment 39. 39. The method of embodiment 38, wherein the passive locking mechanism comprises a pair of resilient arms biased toward the tension ring, and wherein the first pair of extensions disengages the passive locking mechanism by moving the pair of arms away from the tension ring. Embodiment 40. 40. The method of embodiment 39, wherein each of the pair of arms comprises a first inclined surface at its respective distal end, and each of the first pair of extensions comprises a second inclined surface at its respective distal end configured to engage with and slide along the first inclined surface. Embodiment 41. 41. The method of any one of embodiments 38-40, wherein the passive locking mechanism is engaged to prevent or limit compression of the interbody device by moving the inserter proximally away from the interbody device, leaving the interbody device in the desired position.

[0056] While particular embodiments have been illustrated and described herein, it should be understood that various other changes and modifications can be made without departing from the spirit and scope of the claimed subject matter. Moreover, although various aspects of the claimed subject matter are described herein, such aspects need not be utilized in combination. It should also be noted that some of the embodiments disclosed herein may be disclosed in connection with a particular approach (e.g., lateral), however, other approaches (e.g., anterior, posterior, transforaminal, etc.) are also contemplated.

[0057] Unless otherwise indicated, all numbers expressing quantities of ingredients, properties such as molecular weight, reaction conditions, and the like used in the specification and claims should be understood to be modified in all instances by the term "about." Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and appended claims are approximations that may vary depending on the desired properties sought to be obtained by the embodiments of the present disclosure. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the present disclosure are approximations, the numerical values ​​set forth in the specific examples are reported as precisely as possible. However, any numerical value inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. In one embodiment, the terms "about" and "approximately" refer to a numerical parameter within 10% of the stated range.

[0058] As used in the context of describing embodiments of the present disclosure (particularly in the context of the claims below), the terms “a,” “an,” “the,” and similar referents should be construed to encompass both the singular and the plural unless otherwise indicated herein or clearly contradicted by context. The recitation of ranges of values ​​herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each separate value is incorporated herein as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or clearly contradicted by context. The use of any and all examples or exemplary language (e.g., “etc.”) provided herein is intended merely to better clarify embodiments of the present disclosure and does not limit the scope of the disclosure. No language in the specification should be construed as indicating any non-claimed element essential to the practice of embodiments of the present disclosure.

[0059] Groupings of alternative elements or embodiments disclosed herein are not to be construed as limiting. Each group member may be referenced and claimed individually or in any combination with other members of the group or other elements found herein. It is anticipated that one or more members of a group may be included in or deleted from a group for reasons of convenience and / or patentability. When such inclusion or deletion occurs, the specification is deemed to include the group as modified and thus fulfill all Markush group descriptions used in the appended claims.

[0060] Certain embodiments are described herein, including the best mode known to the authors of the present disclosure for carrying out the embodiments disclosed herein. Of course, variations on these described embodiments will become apparent to those skilled in the art upon reading the foregoing description. The authors expect those skilled in the art to employ such variations as appropriate, and the authors intend for the embodiments of the present disclosure to be practiced otherwise than as specifically described herein. Accordingly, this disclosure includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, this disclosure encompasses any combination of the above-described elements in all possible variations thereof unless otherwise indicated herein or clearly contradicted by context.

[0061] Certain embodiments disclosed herein may be further limited in the claims using the language "consisting of" or "essentially consisting of." When used in a claim, the transitional term "consisting of" excludes any element, step, or ingredient not specified in the claim, whether added at the time of filing or by amendment. The transitional term "consisting essentially of" limits the scope of the claim to the specified materials or steps, as well as those that do not materially affect the basic and novel characteristics. Embodiments of the present disclosure so claimed are essentially or expressly described and enabled herein.

[0062] Additionally, where patents and printed publications are referenced throughout this disclosure, each of these references and printed publications is herein individually incorporated by reference in its entirety.

[0063] Finally, it is to be understood that the embodiments disclosed herein are illustrative of the principles of the present disclosure. Other modifications that may be used are within the scope of the present disclosure. Thus, by way of example, and not of limitation, alternative configurations of the embodiments of the present disclosure may be utilized in accordance with the teachings herein. Accordingly, the present disclosure is not limited to that precisely as shown and described.

[0064] CROSS-REFERENCE TO RELATED APPLICATIONS Pursuant to 35 U.S.C. §119(e), this application claims priority to U.S. Provisional Patent Application No. 63 / 427,380 (the "'380 Application"), filed November 22, 2022, and entitled "System and Vertebral Body Replacement Insertion Device," the entire disclosure of which is incorporated herein by reference.

Claims

1. A vertebral body replacement device sized to be implanted between a first vertebra and a second vertebra, comprising: an extendable body configured to extend from a first end to a second end along a longitudinal axis, the extendable body having an outer column, an inner column threadedly coupled to the outer column and translatable relative to the outer column along the longitudinal axis, and an extension ring; the tension ring is rotatable about the longitudinal axis to translate the outer column relative to the inner column to adjust a body length of the extendable body, the tension ring comprising a plurality of radially extending teeth for engaging arms of the outer column and a plurality of teeth for engaging an inserter device; the outer column includes the arms for engaging teeth of the plurality of radially extending teeth of the tension ring; a first locking configuration in which the arms of the outer column prevent the tension ring from rotating relative to the outer column, and a second unlocking configuration in which the arms are extended outward to disengage the teeth of the plurality of radially extending teeth, allowing the tension ring to rotate relative to the outer column.

2. 2. The vertebral body replacement device of claim 1, wherein the outer column comprises a first arm for engaging a first tooth of the plurality of radially extending teeth of the tension ring, and the outer column further comprises a second arm for engaging a second tooth of the plurality of radially extending teeth of the tension ring.

3. The vertebral body replacement device of claim 2 , wherein the first arm and the second arm are integrally formed with the outer column by slots cut from a wall of the outer column.

4. The vertebral body replacement device of claim 2 , wherein the first arm and the second arm each include an inwardly facing sloped surface.

5. 3. The vertebral body replacement device of claim 2, wherein the first arm and the second arm include inwardly extending protrusions for engaging teeth of the plurality of radially extending teeth of the tension ring.

6. The vertebral body replacement device of claim 2 , wherein the expandable body includes a first endplate at the first end and a second endplate at the second end.

7. 7. The vertebral body replacement device of claim 6, wherein the first and second endplates independently have one of the following shapes: square, circular, rectangular, oval, and kidney bean.

8. The vertebral body replacement device of claim 6 , wherein at least one endplate is modularly connectable to the first or second end.

9. The vertebral body replacement device of claim 8 , wherein the at least one endplate is configured to connect the first or second end at two or more angles relative to the vertebral body replacement device.

10. The vertebral body replacement device of claim 6 , wherein at least one of the first and second end plates is integral with the medial or lateral column, respectively.

11. a connector at the first end of the inner column having a facet for attachment to an end plate; an end plate comprising a set screw and a plate, the set screw being trapped within the plate between an inner annular ridge and an inner rim; Equipped with The vertebral body replacement device of claim 1 , wherein the endplate is connectable to the medial column.

12. The vertebral body replacement device of claim 11 , wherein the facets are sinusoidal.

13. 12. The vertebral body replacement device of claim 11, wherein the inner annular ridge of the plate defines an opening with an inner diameter pattern, the opening receiving the facet of the connector of the outer column, and the inner diameter pattern of the set screw connectable to the facet of the connector of the outer column.

14. a connector at the first end of the inner column having a facet for attachment to a set screw of an end plate; an end plate comprising a set screw and a plate, the set screw being trapped within the plate between an inner annular ridge and an inner rim, the set screw having an internal pattern; Equipped with The vertebral body replacement device of claim 1 , wherein the endplate is connectable to the medial column.

15. 14. The vertebral body replacement device of claim 13, wherein the inner annular ridge of the plate defines an opening with an inner pattern, the opening receiving the facet of the connector of the outer column, and the inner pattern of the set screw configured to engage the facet of the connector of the outer column.

16. an extendable body configured to extend from a first end to a second end along a longitudinal axis, the extendable body having an outer column, an inner column threadedly coupled to the outer column and movable relative to the outer column along the longitudinal axis, and an extension ring; the tension ring is rotatable about the longitudinal axis to adjust the relative position of the outer column with respect to the inner column to adjust the body length of the extendable body, the tension ring comprising a passive lock; the outer column includes an arm for engaging the passive lock of the tension ring; Extendable interbody device.

17. an extendable body configured to extend along a longitudinal axis from a first end to a second end; an end plate with a set screw and a plate; Equipped with the extendable body having an outer column, an inner column threadedly coupled to the outer column and translatable relative to the outer column along the longitudinal axis, and an extension ring; the tension ring is rotatable about the longitudinal axis to translate the outer column relative to the inner column to adjust the body length of the extendable body; the outer column having a first end and a second end, the first end having a connector for attachment to a set screw of an end plate; the set screw is trapped within the plate between an inner annular ridge and an inner rim; the end plate is connectable to the outer column; Vertebral body replacement system.

18. 18. The vertebral body replacement system of claim 17, wherein the connector of the outer column further comprises a facet, and the inner annular ridge of the plate defines an opening having an inner diameter, the opening receiving the facet of the connector of the outer column, and the set screw configured to engage the connector of the outer column.

19. 20. The vertebral body replacement system of claim 17, further comprising a passive locking mechanism.

20. the passive locking mechanism includes the expansion ring having a plurality of radially extending teeth for engaging the arms of the outer column and a plurality of teeth for engaging an inserter device; the outer column includes the arms for engaging teeth of the plurality of radially extending teeth of the tension ring; 20. The vertebral body replacement system of claim 19, wherein the arms of the outer column have a first locked configuration in which the tension ring cannot move relative to the outer column and a second unlocked configuration in which the arms are extended outward and disengaged from the plurality of radially extending teeth to allow the tension ring to rotate relative to the outer column.

Images