US20230404771A1 - Expandable footprint implant - Google Patents
Expandable footprint implant Download PDFInfo
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- US20230404771A1 US20230404771A1 US17/841,705 US202217841705A US2023404771A1 US 20230404771 A1 US20230404771 A1 US 20230404771A1 US 202217841705 A US202217841705 A US 202217841705A US 2023404771 A1 US2023404771 A1 US 2023404771A1
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- A61F2002/30579—Special structural features of bone or joint prostheses not otherwise provided for with mechanically expandable devices, e.g. fixation devices
Definitions
- the present disclosure generally relates to devices and methods for promoting an intervertebral fusion, and more particularly relates to expandable fusion devices capable of being inserted between adjacent vertebrae to facilitate the fusion process.
- intervertebral fusion devices for fusing one or more adjacent vertebral bodies.
- the intervertebral disc is first partially or fully removed.
- An intervertebral fusion device is then inserted between neighboring vertebrae to maintain normal disc spacing and restore spinal stability, thereby facilitating an intervertebral fusion.
- fusion devices and methodologies for accomplishing the intervertebral fusion include screw and rod arrangements, solid bone implants, and fusion devices which include a cage or other implant mechanism, which may be packed with bone and/or bone growth inducing substances, for example. These devices are implanted between adjacent vertebral bodies in order to fuse the vertebral bodies together, alleviating the associated pain.
- expandable intervertebral implants for example, for posterior spinal surgery may be used to treat a variety of patient indications.
- the expandable implants are configured to increase the overall footprint size after being inserted into the disc space while also adjusting the lordosis and overall height.
- the in-situ expandable footprint or surface area is configured to address the subsidence issue and in-situ adjustable lordosis is configured to address the sagittal balance issue.
- an expandable intervertebral implant includes front and rear plates each having horizontal ramps, a central drive screw for moving the front plate relative to the rear plate, and left and right side portion assemblies.
- the left and right side portion assemblies each include upper and lower endplates having vertical ramps, an actuator having horizontal ramps slidably engaged with the horizontal ramps of the rear plate and vertical ramps slidably engaged with the vertical ramps of the upper and lower endplates, and a front ramp having horizontal ramps slidably engaged with the horizontal ramps of the front plate and vertical ramps slidably engaged with the vertical ramps of the upper and lower endplates.
- the expandable implant may include one or more of the following attributes.
- the rear plate may include a pair of female horizontal ramps defined into top and bottom surfaces of the rear plate, and the actuator may include a pair of horizontal male ramps configured to interface with the female horizontal ramps of the rear plate.
- the horizontal ramps of the rear plate may be slanted such that one end of each ramp starts at a side of the rear plate and extends toward a center of the rear plate with the horizontal ramps leading toward one another.
- One of the female horizontal ramps may have a depth greater than the other female horizontal ramp.
- the front plate may include a pair of female horizontal ramps defined into top and bottom surfaces of the front plate, and the front ramp may include a pair of male horizontal ramps configured to interface with the female horizontal ramps of the front plate.
- the horizontal ramps of the front plate may be slanted such that one end of each ramp starts at a side of the front plate and extends toward a center of the front plate with the horizontal ramps leading toward one another.
- One of the female horizontal ramps may have a depth greater than the other female horizontal ramp.
- an expandable intervertebral implant includes front and rear plates, a central drive screw, and left and right side portion assemblies.
- the front plate has at least one ramp and the rear plate has at least one ramp.
- the central drive screw is threadedly engaged with a drive sleeve.
- the central drive screw is retained in the rear plate and the drive sleeve retained in the front plate.
- the left and right side portion assemblies each include an upper endplate, a lower endplate, an actuator, and a front ramp.
- the actuator includes a ramp slidably engaged with the ramp of the rear plate, and the front ramp includes a ramp slidably engaged with the ramp of the front plate. Rotation of the drive screw moves the front plate toward the rear plate and the ramp of the actuator slides across the ramp of the rear plate, and the ramp of the front ramp slides across the ramp of the front plate, thereby expanding a width of the implant.
- the expandable implant may include one or more of the following attributes.
- the ramps of the front plate and the rear plate may include horizontal ramps aligned along one or more horizontal planes.
- the rear plate may include a pair of female ramps defined into top and bottom surfaces of the rear plate, and the actuator may include a pair of male ramps configured to interface with the female ramps of the rear plate.
- the front plate may include a pair of female ramps defined into top and bottom surfaces of the front plate, and the front ramp may include a pair of male ramps configured to interface with the female ramps of the front plate.
- the left and right side portion assemblies may have a laterally collapsed configuration having a first width and a laterally expanded configuration having a second width.
- the left and right side portion assemblies may have a vertically collapsed configuration having a first height and a vertically expanded configuration having a second height. Rotation of the drive screw moves the front plate toward the rear plate, thereby first transitioning the left and right side portion assemblies to the laterally expanded configuration and then to the vertically expanded configuration.
- the drive sleeve may include a tubular body with an internally threaded bore, and the central drive screw may include an externally threaded shaft allowing for threaded engagement with the internally threaded bore of the drive sleeve.
- an expandable intervertebral implant includes front and rear plates each having horizontal and vertical ramps, a central drive screw for moving the front plate relative to the rear plate, an expandable assembly, and a stationary assembly.
- the expandable assembly includes an upper endplate, a lower endplate, an actuator, and a front ramp.
- the upper and lower endplates include vertical ramps.
- the actuator includes horizontal ramps interfacing with the horizontal ramps of the rear plate and vertical ramps interfacing with the vertical ramps of the upper and lower endplates.
- the front ramp has horizontal ramps interfacing with the horizontal ramps of the front plate and vertical ramps interfacing with the vertical ramps of the upper and lower endplates.
- the stationary assembly includes upper and lower endplates having vertical ramps interfacing with the vertical ramps of the front and rear plates. Rotation of the drive screw moves the front plate toward the rear plate, thereby expanding the expandable assembly in width and then expanding both the expandable and stationary assemblies in height.
- the expandable implant may include one or more of the following attributes.
- the front and rear plates may include only a single horizontal ramp on top and bottom faces of the plates to engage with a single actuator and front ramp of the expandable assembly, respectively.
- the front and rear plates may each include a female horizontal ramp configured to interface with male horizontal ramps of the actuator and front ramp of the expandable assembly, respectively.
- the upper and lower endplates of the expandable assembly may define female vertical ramps configured to interface with male vertical ramps of the actuator and front ramp, respectively.
- an expandable intervertebral implant includes front and rear plates, a central drive screw threadedly engaged with a drive sleeve, the central drive screw retained in the rear plate and the drive sleeve retained in the front plate, left and right side portion assemblies each including upper and lower endplates, an actuator, and a front ramp, and an endplate clip positioned around the drive sleeve to prevent expansion of the upper and lower endplates in height until the left and right side portion assemblies are fully expanded in width.
- the expandable implant may include one or more of the following attributes.
- the endplate clip may include a ring with a plurality of posts configured to engage the upper and lower endplates.
- the ring may include a full ring defining a central bore sized and dimensioned to snuggly fit around the drive sleeve.
- the posts may extend from the ring and terminate at one or more free ends. Before the implant is fully expanded, the free ends of the posts are receivable in bores through a side wall of the endplates, thereby preventing any expansion in height.
- Rotation of the drive screw moves the front plate toward the rear plate and the ramp of the actuator slides across the ramp of the rear plate, the ramp of the front ramp slides across the ramp of the front plate, thereby expanding a width of the implant.
- the endplate clip prevents expansion of the upper and lower endplates in height until the left and right side portion assemblies are fully expanded in width.
- the expandable implant may include one or more of the following attributes.
- the endplate clip may include one or more posts receivable in corresponding bores in the upper and lower endplates. The endplate clip only permits lateral expansion of the expandable assembly until the posts disengage from the bores in the upper and lower endplates. A first post is receivable in the bore in the upper endplate and a second post is receivable in the bore in the lower endplate, and the first and second posts may be aligned in parallel.
- a method of assembling an expandable implant includes, in any suitable order: (1) placing two front ramps onto a front plate by aligning the ramp/sliding features of the two components; (2) placing two actuators onto a rear plate by aligning the ramp/sliding features of the two components; (3) assembling each of the left and right side assemblies by (a) placing lower and upper endplates onto the actuator and placing a front ramp into both the lower and upper endplates or (b) placing the upper endplate onto the actuator and placing the front ramp onto the upper endplate, then placing the lower endplate onto both the actuator and the front ramp while ensuring all ramps are engaged with one another; (4) inserting a threaded drive sleeve into the front plate and securing with a lock nut; (5) securing an endplate clip to the threaded sleeve and engaging posts of the endplate clip into bores in the endplates; (6) assembling a friction ring onto the drive screw and inserting the drive screw through the rear plate; (7) thread
- FIGS. 1 A- 1 C illustrate perspective views of an expandable implant in a collapsed position, expanded in width, and expanded in width and height, respectively, according to one embodiment
- FIG. 2 shows an exploded view of the expandable implant of FIGS. 1 A- 1 C ;
- FIG. 3 show an exploded view of a retaining ring positionable on the drive shaft of the expandable implant to secure the drive shaft to the rear plate according to one embodiment
- FIG. 4 shows an exploded view of a drive sleeve insertable into the front plate and configured to be retained by a lock nut according to one embodiment
- FIG. 5 shows the rear plate attached to the drive screw, the drive sleeve attached to the front plate, and the drive screw threadedly engaged to the drive sleeve of the expandable implant according to one embodiment
- FIG. 6 shows the top endplate assembled onto the actuator and the front ramp and a lower endplate configured to be placed onto the actuator and front ramp during assembly;
- FIG. 7 shows a cross-sectional view of the ramps of the upper and lower endplates engaged with the actuator and front ramp according to one embodiment
- FIG. 8 shows the actuator of the side assemblies according to one embodiment
- FIGS. 10 A- 10 C illustrate the actuators slidably engaged with the rear plate in a collapsed position and expanded in width, respectively, and a close-up view of the interaction between the actuator and the rear plate according to one embodiment
- FIG. 12 shows an endplate clip positioned around the drive sleeve configured to prevent the side assemblies from expanding in height until fully expanded in width according to one embodiment (the second set of endplates are omitted for clarity);
- FIGS. 13 A- 13 D shows the endplate clip engaged and disengaged from the endplates, respectively (the second set of endplates and the drive sleeve are omitted for clarity);
- FIG. 14 is a rear view of the assembly expanded in width and height according to one embodiment
- FIGS. 15 A- 15 C shows the implant in a fully collapsed position, fully expanded in width, and fully expanded in width and height, respectively (one side assembly including one set of endplates, actuator, and front ramp are omitted for clarity);
- FIGS. 16 A- 16 C illustrate an expandable implant in a collapsed position, one side expanded in width, and both sides expanded in height, respectively, according to one embodiment.
- Embodiments of the disclosure are generally directed to devices, systems, and methods for intervertebral fusion.
- expandable implants are configured to increase the overall footprint size after being inserted into the disc space while also adjusting the lordosis and overall height.
- the expandable implants may include one or more side assemblies configured to expand in width and in height. In doing so, the expansion addresses sagittal balance correction and subsidence issues.
- a spinal fusion is typically employed to eliminate pain caused by the motion of degenerated disc material.
- a fusion device becomes permanently fixed within the intervertebral disc space.
- the expandable fusion device may be positioned between adjacent vertebral bodies in a collapsed position.
- the expandable fusion device is configured to expand in width and subsequently in height.
- the fusion device engages the endplates of the adjacent vertebral bodies and, in the installed position, maintains desired intervertebral disc spacing and restores spinal stability, thereby facilitating an intervertebral fusion.
- MIS Minimally invasive surgery
- the expandable fusion device can be configured to be placed down an endoscopic tube and into the surgical target site.
- the surgical site may be an intervertebral disc space situated between two adjacent vertebrae.
- the implant may be employed in any number of suitable orthopedic approaches and procedures, including but not limited to, anterior, posterior, lateral, anterolateral, or posterolateral approaches to the lumbar spine, cervical spine, or thoracic spine, as well as any non-spine application, such as treatment of bone fractures and the like.
- suitable orthopedic approaches and procedures including but not limited to, anterior, posterior, lateral, anterolateral, or posterolateral approaches to the lumbar spine, cervical spine, or thoracic spine, as well as any non-spine application, such as treatment of bone fractures and the like.
- Components of all of the devices disclosed herein may be manufactured of any suitable materials including metals (e.g., titanium), metal alloys (e.g., stainless steel, cobalt-chromium, and titanium alloys), ceramics, plastics, plastic composites, or polymeric materials (e.g., polyether ether ketone (PEEK), polyphenylene sulfone (PPSU), polysulfone (PSU), polycarbonate (PC), polyetherimide (PEI), polypropylene (PP), polyacetals, or mixtures or co-polymers thereof), and/or combinations thereof.
- the devices may include radiolucent and/or radiopaque materials.
- the components can also be machined and/or manufactured using any suitable techniques (e.g., 3D printing).
- the expandable fusion device 10 extends along a central longitudinal axis A between front and rear ends of the device 10 .
- FIG. 1 A shows the expandable fusion device 10 in a fully collapsed configuration with the left and right side portions 12 , 14 collapsed in both width and height.
- FIG. 1 B shows the expandable fusion device 10 in an expanded configuration with the left and right side portions 12 , 14 expanded in width.
- FIG. 1 C shows the expandable fusion device in a fully expanded configuration with the left and right side portions 12 , 14 expanded in width and in height.
- references to the front and rear ends and left and right side portions 12 , 14 are described with respect to the direction of placement into an intervertebral disc space with the front of the expandable fusion device 10 placed into the disc space first, followed by the rear of the expandable fusion device 10 .
- These and other directional terms may be used herein for descriptive purposes and do not limit the orientation(s) in which the devices may be used.
- movement of the first half or left side portion 12 and the second half or right side portion 14 of the implant 10 is controllable by a central drive screw 16 which is attached to a front distal plate 20 and rear proximal plate 22 .
- the drive screw 16 pulls the distal plate 20 towards the proximal plate 22 and pushes the left and right portions 12 , 14 outwards via horizontal ramps or slides 56 , 70 , 90 , 104 .
- the drive screw 16 is configured to pull the front distal plate 20 towards the rear proximal plate 22 , thereby pushing the left and right side portions 12 , 14 outwards and away from one another via the mating horizontal ramps 56 , 70 , 90 , 104 along the front and rear plates 20 , 22 , the actuators 28 , and the front ramps 30 , respectively.
- Rotation of the drive screw 16 pulls the front ramps 30 toward the actuators 28 , which then expands the top and bottom endplates 24 , 26 via mating vertical ramps 80 , 92 , 102 between the endplates 24 , 26 , the actuators 28 , and the front ramps 30 , respectively.
- the drive screw 16 extends from a proximal end 40 to a distal end 42 .
- the proximal end 40 may include an enlarged head portion configured to be received in a bore 44 defined through the rear proximal plate 22 .
- the bore 44 in the rear plate 22 may be internally threaded to provide for a threaded connection to the rear plate 22 , for example, allowing for a rigid connection to an insertion instrument.
- the proximal end 40 of the drive screw 22 may define an instrument recess 48 configured to receive an instrument, such as a driver, to rotate or actuate the drive screw 16 .
- the rear plate 22 may include one or more instrument slots 52 configured to be engaged by an instrument, such as an insertion instrument.
- the top and bottom faces of the rear plate 22 may each include a pair of instrument slots 52 .
- the rear plate 22 may also define one or more side recesses 54 configured to receive a graft delivery device.
- opposite sides of the rear plate 22 may include two opposed semi-circular recesses 54 configured to allow the graft delivery device to enter the central portion of the implant 10 once fully expanded in width and/or height.
- Bone graft or similar bone growth inducing material can be introduced within and/or around the fusion device 10 to further promote and facilitate the intervertebral fusion.
- the drive sleeve 18 may have an exterior threaded portion 62 at its distal end.
- the distal threaded portion 62 may fit into an opening 64 defined through the front distal plate 20 .
- the drive sleeve 18 may be secured to the front distal plate 20 with the lock nut 34 .
- the lock nut 34 may include a ring with a central bore defining internal threads.
- the drive sleeve 18 may be secured to the front distal plate 20 by coupling the internally threaded lock nut 34 to the distal threaded portion 62 of the drive sleeve 18 .
- An outward face of the lock nut 34 may include one or more instrument recesses for engagement with an instrument to rotate the lock nut 34 .
- the drive sleeve 18 may be keyed to the opening 64 through the front plate 20 with one or more keying portions 66 configured to ensure the orientation of the drive sleeve 18 relative to the front plate 20 .
- the keying portions 66 may include a pair of opposite wings on an outer surface of the sleeve 18 configured to mate with a corresponding keyway through the opening 64 .
- the wings 66 may extend between upper and lower portions of the sleeve 18 and may have a central vertical opening therebetween.
- the wings 66 may include planar surfaces, curved surfaces, or other suitable surfaces configured to mate with the corresponding opening 64 .
- any suitable number, type, or configuration of keying portions 66 may be selected to align the sleeve 18 with the front plate 20 .
- the keying portions 66 may include a dovetail interface, finger joint, pin(s), or other suitable keying feature(s) to ensure the desired orientation.
- the keying portions 66 and opening 64 are aligned to lock the sleeve 18 from rotation. When the drive screw 16 is rotated or actuated, the drive sleeve 18 and attached front plate 20 are drawn toward the rear plate 22 , thereby providing for expansion of the device 10 .
- the distal end 96 of the front ramp 30 may define one or more horizontal ramps 104 configured to engage with the horizontal ramps 70 of the front plate 20 .
- the front ramp 30 may define a pair of top and bottom horizontal ramps 104 separated by a gap and pointing inwardly toward one another.
- the horizontal ramps 104 may have an angled, diagonal, or slanted surface in a manner complimentary to the ramps 70 of the front plate 20 .
- the horizontal ramps 104 may define male projections configured to enter the female counterparts 70 of the front plate 20 .
- Front ramps 30 and front plate 20 utilize a similar sliding interface as actuators 28 and rear plate 22 .
- FIGS. 11 A- 11 B show the front ramps 30 slidably engaged with the front plate 20 in collapsed and expanded positions, respectively. Front ramps 30 slide onto the front plate 20 by aligning keying features that control expansion.
- FIG. 11 A the front ramps 30 are engaged with the front plate 20 and collapsed onto one another.
- a recessed surface 108 on top of one front ramp 30 sized and dimensioned to receive the other front ramp 30 permits the front ramps 30 to nest together, thereby providing a small footprint for insertion. It will be appreciated that a corresponding recessed surface 108 may be provided on the bottom of the opposite front ramp 30 to provide for a complimentary fit.
- one horizontal ramp 70 may be positioned at a depth greater than the other horizontal ramp 70 to further facilitate this nesting configuration of the front ramps 30 .
- the horizontal ramps 104 of the front ramps 20 slidably interface with the horizontal ramps 70 of the front plate 20 .
- the front ramps 20 may have features that engage with the mating front plate 20 that limit the amount of translation while expanding in width.
- the actuators 28 are fully expanded in width. When expanded in width, the front ramps 20 slide outward and away from one another, thereby increasing the overall width of the implant 10 .
- a first post 114 may be positioned above the ring 112 with two opposed free ends 116 extending into the left and right upper endplates 24 , respectively, and a second post 114 may be positioned below the ring 112 with two opposed free ends 116 extending into the left and right lower endplates 26 , respectively.
- the two posts 114 may be aligned in parallel, for example, horizontally in line with the upper and lower endplates 24 , 26 .
- four separate posts 114 may extend from the ring 112 and terminate at free ends 116 each receivable in the respective endplates 24 , 26 .
- FIGS. 13 A and 13 C show the endplate clip 32 and one set of endplates 24 , 26 (the opposite set of endplates are omitted for clarity) before the left and right side assemblies 12 , 14 are fully expanded in width.
- the ends 116 of the posts 114 are received in the bores 84 through the side wall 78 of the endplates 24 , 26 .
- the endplates 24 , 26 are unable to expand in height.
- FIGS. 13 B and 13 D show the endplate clip 32 disengaged from the endplates 24 , 26 .
- FIG. 14 shows a rear view of the assembled implant 10 fully expanded in width and in height.
- the rear plate 22 defines recesses 54 and the actuators 28 allow entry to a central portion of the implant 10 to allow delivery of graft material into the implant 10 once fully expanded in width.
- FIGS. 15 A- 15 C show the implant 10 with the right side assembly 14 (one set of endplates 24 , 26 , actuator 28 , and front ramp 30 and hidden for clarity).
- the implant 10 is fully collapsed and may be inserted into a disc space, for example, through a posterior approach.
- the implant 10 may be attached to a multi-component instrument, for example, and a driving instrument may be used to engage the recess 48 in the drive screw 16 with a compatible drive feature.
- the drive screw 16 When the drive screw 16 is rotated, the screw 16 pulls and translates the screw sleeve 18 , attached front plate 20 , and attached front ramps 30 proximally. When doing so, it will force the front ramps 30 to translate outward and expand in width.
- FIG. 15 B shows the implant 10 fully expanded in width. Once the front ramps 30 are translated outward and full width expansion occurs, the front ramps 30 continue to translate with the screw sleeve 18 and attached front plate 20 proximally, thereby forcing the ramp features 80 , 92 , 102 of the actuators 28 , front ramps 30 , and endplates 24 , 26 to translate the endplates 24 , 26 upward and downward, respectively.
- FIG. 15 C show the implant 10 fully expanded in width and in height. The amount of height of expansion on the left and right side assemblies 12 , 14 may be the same or different. In this manner, the implant 10 is expanded in width for an increased footprint to aid in overall stability and the implant 20 is adjusted in lordosis and height for a precise patient fit.
- the implant 10 may be assembled as follows.
- the two front ramps 30 are placed onto front plate 20 by aligning the ramp/sliding features 70 , 104 .
- the two actuators 28 are placed onto rear plate 22 by aligning the ramp/sliding features 56 , 90 .
- the left and right sides 12 , 14 are each assembled as follows.
- the lower endplate 26 is placed onto actuator 28 .
- the upper endplate 24 is placed onto actuator 28 .
- the front ramp 30 is placed into both the lower and upper endplates 24 , 26 .
- the upper endplate 24 is placed onto the actuator and the front ramp 20 is placed onto the upper endplate 24 .
- the lower endplate 26 is placed onto both the actuator 28 and the front ramp 20 while ensuring all ramps 80 , 92 , 102 are engaged with each other.
- the threaded sleeve 18 is inserted into the front plate 20 and secured with the lock nut 34 .
- the endplate clip 32 is slid onto the threaded sleeve 18 to engage four posts 114 into the bores 84 of the endplates 24 , 26 .
- the PEEK ring 38 is assembled onto the drive screw 16 which are then inserted through the rear plate 22 , threaded into drive sleeve 18 , and retained by the lock ring 36 .
- expandable fusion device or implant 210 is similar to implant 10 except only one of the side portion assemblies 212 is configured to expand in width and the other 214 remains stationary.
- Implant 210 includes a first half or left side portion 212 , which is moveable to expand in width and a second half or right side portion 214 , which does not expand in width. Both of the left and right side portions 212 , 214 expand in height.
- side portion 212 is shown as moveable and side portion 214 as stationary, it will be appreciated that the configuration may be reversed.
- the left and right assemblies 212 , 214 are controllable by a central drive screw 216 which is attached to a drive sleeve 218 , a front distal plate 220 and a rear proximal plate 222 .
- the drive screw 216 pulls the distal plate 220 towards the proximal plate 222 and pushes only one side portion 212 outwards with the use of ramps/slide mechanisms 256 , 270 , 290 , 304 .
- the rear plate 222 includes a female horizontal ramp 256 slidably engaged with a male horizontal ramp 290 on the actuator 228 and the front plate 220 includes a female horizontal ramp 270 slidably engaged with a male horizontal ramp 304 on the front ramp 230 .
- the front and rear plates 220 , 222 include only a single horizontal ramp 256 , 270 on each of the top and bottom faces of the plates 220 , 222 to engage with a single actuator 228 and front ramp 230 , respectively.
- the implant 210 may include an endplate clip, similar to endplate clip 32 , with posts to engage only the moveable side 212 .
- the single side 212 that expands outwards includes upper and lower endplates 224 , 224 , actuator 228 , and front ramp 230 , which is configured to expand in height via internal vertical ramps. The front distal plate 220 along with the single front ramp 230 is actuated while the drive screw 216 is turned.
- the single side 214 that does not expand laterally outward has incorporated the front ramp features into the front distal plate 220 and the actuator features into the rear proximal plate 222 .
- the non-expanding side 214 includes upper and lower endplates 224 , 226 directly engaged with ramps on the front and rear plates 220 , 222 .
- the front distal plate 220 includes one or more vertical ramps, similar to ramps 102 , configured to slidably interface with the vertical ramps of the endplates 224 , 226 .
- the rear plate 222 has an enlarged body with one or more vertical ramps, similar to ramps 92 , configured to slidably interface with the vertical ramps of the endplates 224 , 266 . This allows the endplates 224 , 226 on the non-width expanding side 214 to also expand in height. The amount of height of expansion on the expanding side 212 and non-expanding side 214 may be the same or different.
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Abstract
Expandable fusion implants capable of being installed inside an intervertebral disc space to maintain disc spacing and restore spinal stability, thereby facilitating an intervertebral fusion. The expandable intervertebral implant may be configured to transition from a collapsed configuration having a first width and a first height to an expanded configuration having a second width and a second height. The implant may include front and rear plates each having horizontal ramps configured to interface with corresponding horizontal ramps on actuators and front ramps of left and/or right side portion assemblies.
Description
- The present application is a continuation of U.S. patent application Ser. No. 17/841,118 filed on Jun. 15, 2022, which is incorporated in its entirety herein.
- The present disclosure generally relates to devices and methods for promoting an intervertebral fusion, and more particularly relates to expandable fusion devices capable of being inserted between adjacent vertebrae to facilitate the fusion process.
- A common procedure for handling pain associated with intervertebral discs that have become degenerated due to various factors, such as trauma or aging, is the use of intervertebral fusion devices for fusing one or more adjacent vertebral bodies. Generally, to fuse the adjacent vertebral bodies, the intervertebral disc is first partially or fully removed. An intervertebral fusion device is then inserted between neighboring vertebrae to maintain normal disc spacing and restore spinal stability, thereby facilitating an intervertebral fusion.
- There are a number of fusion devices and methodologies for accomplishing the intervertebral fusion. These include screw and rod arrangements, solid bone implants, and fusion devices which include a cage or other implant mechanism, which may be packed with bone and/or bone growth inducing substances, for example. These devices are implanted between adjacent vertebral bodies in order to fuse the vertebral bodies together, alleviating the associated pain.
- However, there are drawbacks associated with the known conventional fusion devices and methodologies. For example, present methods for installing a conventional fusion device often require that the adjacent vertebral bodies be distracted to restore a diseased disc space to its normal or healthy height prior to implantation of the fusion device. In order to maintain this height once the fusion device is inserted, the fusion device is usually dimensioned larger in height than the initial distraction height. This difference in height can make it difficult for a surgeon to install the fusion device in the distracted intervertebral space.
- As such, there exists a need for fusion devices capable of being installed inside an intervertebral disc space at a minimum to no distraction height and for a fusion device that can maintain a normal distance between adjacent vertebral bodies when implanted. In addition, it is desired to address issues with subsidence and sagittal balance as well.
- To meet this and other needs, devices, systems, and methods for performing intervertebral fusion are provided. In particular, expandable intervertebral implants, for example, for posterior spinal surgery may be used to treat a variety of patient indications. The expandable implants are configured to increase the overall footprint size after being inserted into the disc space while also adjusting the lordosis and overall height. The in-situ expandable footprint or surface area is configured to address the subsidence issue and in-situ adjustable lordosis is configured to address the sagittal balance issue.
- According to one embodiment, an expandable intervertebral implant includes front and rear plates each having horizontal ramps, a central drive screw for moving the front plate relative to the rear plate, and left and right side portion assemblies. The left and right side portion assemblies each include upper and lower endplates having vertical ramps, an actuator having horizontal ramps slidably engaged with the horizontal ramps of the rear plate and vertical ramps slidably engaged with the vertical ramps of the upper and lower endplates, and a front ramp having horizontal ramps slidably engaged with the horizontal ramps of the front plate and vertical ramps slidably engaged with the vertical ramps of the upper and lower endplates. By rotating the drive screw, the implant expands in width and then in height.
- The expandable implant may include one or more of the following attributes. The rear plate may include a pair of female horizontal ramps defined into top and bottom surfaces of the rear plate, and the actuator may include a pair of horizontal male ramps configured to interface with the female horizontal ramps of the rear plate. The horizontal ramps of the rear plate may be slanted such that one end of each ramp starts at a side of the rear plate and extends toward a center of the rear plate with the horizontal ramps leading toward one another. One of the female horizontal ramps may have a depth greater than the other female horizontal ramp. The front plate may include a pair of female horizontal ramps defined into top and bottom surfaces of the front plate, and the front ramp may include a pair of male horizontal ramps configured to interface with the female horizontal ramps of the front plate. The horizontal ramps of the front plate may be slanted such that one end of each ramp starts at a side of the front plate and extends toward a center of the front plate with the horizontal ramps leading toward one another. One of the female horizontal ramps may have a depth greater than the other female horizontal ramp.
- According to another embodiment, an expandable intervertebral implant includes front and rear plates, a central drive screw, and left and right side portion assemblies. The front plate has at least one ramp and the rear plate has at least one ramp. The central drive screw is threadedly engaged with a drive sleeve. The central drive screw is retained in the rear plate and the drive sleeve retained in the front plate. The left and right side portion assemblies each include an upper endplate, a lower endplate, an actuator, and a front ramp. The actuator includes a ramp slidably engaged with the ramp of the rear plate, and the front ramp includes a ramp slidably engaged with the ramp of the front plate. Rotation of the drive screw moves the front plate toward the rear plate and the ramp of the actuator slides across the ramp of the rear plate, and the ramp of the front ramp slides across the ramp of the front plate, thereby expanding a width of the implant.
- The expandable implant may include one or more of the following attributes. The ramps of the front plate and the rear plate may include horizontal ramps aligned along one or more horizontal planes. The rear plate may include a pair of female ramps defined into top and bottom surfaces of the rear plate, and the actuator may include a pair of male ramps configured to interface with the female ramps of the rear plate. The front plate may include a pair of female ramps defined into top and bottom surfaces of the front plate, and the front ramp may include a pair of male ramps configured to interface with the female ramps of the front plate. The left and right side portion assemblies may have a laterally collapsed configuration having a first width and a laterally expanded configuration having a second width. The left and right side portion assemblies may have a vertically collapsed configuration having a first height and a vertically expanded configuration having a second height. Rotation of the drive screw moves the front plate toward the rear plate, thereby first transitioning the left and right side portion assemblies to the laterally expanded configuration and then to the vertically expanded configuration. The drive sleeve may include a tubular body with an internally threaded bore, and the central drive screw may include an externally threaded shaft allowing for threaded engagement with the internally threaded bore of the drive sleeve. A distal end of the drive sleeve may include an exterior threaded portion receivable through a bore defined through the front plate and a lock nut may be coupled to the threaded portion of the drive sleeve, thereby securing the drive sleeve to the front plate. The drive sleeve may include a pair of keys on an outer surface of the drive sleeve configured to mate with a pair of keyways in the bore of the front plate, thereby preventing the drive sleeve from rotating.
- According to another embodiment, an expandable intervertebral implant includes front and rear plates each having horizontal and vertical ramps, a central drive screw for moving the front plate relative to the rear plate, an expandable assembly, and a stationary assembly. The expandable assembly includes an upper endplate, a lower endplate, an actuator, and a front ramp. The upper and lower endplates include vertical ramps. The actuator includes horizontal ramps interfacing with the horizontal ramps of the rear plate and vertical ramps interfacing with the vertical ramps of the upper and lower endplates. The front ramp has horizontal ramps interfacing with the horizontal ramps of the front plate and vertical ramps interfacing with the vertical ramps of the upper and lower endplates. The stationary assembly includes upper and lower endplates having vertical ramps interfacing with the vertical ramps of the front and rear plates. Rotation of the drive screw moves the front plate toward the rear plate, thereby expanding the expandable assembly in width and then expanding both the expandable and stationary assemblies in height.
- The expandable implant may include one or more of the following attributes. The front and rear plates may include only a single horizontal ramp on top and bottom faces of the plates to engage with a single actuator and front ramp of the expandable assembly, respectively. The front and rear plates may each include a female horizontal ramp configured to interface with male horizontal ramps of the actuator and front ramp of the expandable assembly, respectively. The upper and lower endplates of the expandable assembly may define female vertical ramps configured to interface with male vertical ramps of the actuator and front ramp, respectively.
- According to another embodiment, an expandable intervertebral implant includes front and rear plates, a central drive screw threadedly engaged with a drive sleeve, the central drive screw retained in the rear plate and the drive sleeve retained in the front plate, left and right side portion assemblies each including upper and lower endplates, an actuator, and a front ramp, and an endplate clip positioned around the drive sleeve to prevent expansion of the upper and lower endplates in height until the left and right side portion assemblies are fully expanded in width.
- The expandable implant may include one or more of the following attributes. When the drive screw is rotated, the implant expands in width and once the upper and lower endplates are released from the endplate clip, then the implant expands in height. The endplate clip may include a ring with a plurality of posts configured to engage the upper and lower endplates. The ring may include a full ring defining a central bore sized and dimensioned to snuggly fit around the drive sleeve. The posts may extend from the ring and terminate at one or more free ends. Before the implant is fully expanded, the free ends of the posts are receivable in bores through a side wall of the endplates, thereby preventing any expansion in height. Once fully expanded in width, the endplates move outward and away from one another and the free ends of the posts are released from the bores, thereby allowing the upper and lower endplates to expand in height. A first post may be positioned above the ring with two opposed free ends extending into the upper endplates, respectively, and a second post may be positioned below the ring with two opposed free ends extending into the lower endplates, respectively. The two posts may be aligned in parallel.
- According to another embodiment, an expandable intervertebral implant includes a front plate having at least one ramp and a rear plate having at least one ramp. A central drive screw threadedly engaged with a drive sleeve. The central drive screw retained in the rear plate and the drive sleeve retained in the front plate. Left and right side portion assemblies each including an upper endplate, a lower endplate, an actuator, and a front ramp. The actuator includes a ramp slidably engaged with the ramp of the rear plate, and the front ramp includes a ramp slidably engaged with the ramp of the front plate. An endplate clip is positioned between the drive sleeve and the upper and lower endplates. Rotation of the drive screw moves the front plate toward the rear plate and the ramp of the actuator slides across the ramp of the rear plate, the ramp of the front ramp slides across the ramp of the front plate, thereby expanding a width of the implant. The endplate clip prevents expansion of the upper and lower endplates in height until the left and right side portion assemblies are fully expanded in width.
- The expandable implant may include one or more of the following attributes. The drive sleeve may include a tubular body with an internally threaded bore, and the central drive screw may include an externally threaded shaft allowing for threaded engagement with the internally threaded bore of the drive sleeve. The endplate clip may include a ring fitted over the tubular body of the drive sleeve with a plurality of outwardly extending posts configured to engage the upper and lower endplates. The endplate clip may include a first post affixed to a top of the ring and a second post affixed to a bottom of the ring. The first post may terminate at first and second free ends configured to engage the upper endplates and the second post may terminate at third and fourth free ends configured to engage the lower endplates. The first and second posts may be horizontally aligned with the upper and lower endplates, respectively. Before the implant is fully expanded, the free ends of the posts may be receivable in bores through a side wall of the endplates, thereby preventing any expansion in height.
- According to another embodiment, an expandable intervertebral implant includes front and rear plates each having horizontal ramps, a central drive screw for moving the front plate relative to the rear plate, an expandable assembly including an upper endplate, a lower endplate, an actuator, and a front ramp, wherein the upper and lower endplates include vertical ramps, the actuator includes horizontal ramps engaged with the horizontal ramps of the rear plate and vertical ramps engaged with the vertical ramps of the upper and lower endplates, and the front ramp having horizontal ramps engaged with the horizontal ramps of the front plate and vertical ramps interfacing with the vertical ramps of the upper and lower endplates, and an endplate clip attached to the drive sleeve to prevent expansion of the upper and lower endplates in height until the expandable assembly is fully expanded in width.
- The expandable implant may include one or more of the following attributes. The endplate clip may include one or more posts receivable in corresponding bores in the upper and lower endplates. The endplate clip only permits lateral expansion of the expandable assembly until the posts disengage from the bores in the upper and lower endplates. A first post is receivable in the bore in the upper endplate and a second post is receivable in the bore in the lower endplate, and the first and second posts may be aligned in parallel.
- According to another embodiment, a method of assembling an expandable implant includes, in any suitable order: (1) placing two front ramps onto a front plate by aligning the ramp/sliding features of the two components; (2) placing two actuators onto a rear plate by aligning the ramp/sliding features of the two components; (3) assembling each of the left and right side assemblies by (a) placing lower and upper endplates onto the actuator and placing a front ramp into both the lower and upper endplates or (b) placing the upper endplate onto the actuator and placing the front ramp onto the upper endplate, then placing the lower endplate onto both the actuator and the front ramp while ensuring all ramps are engaged with one another; (4) inserting a threaded drive sleeve into the front plate and securing with a lock nut; (5) securing an endplate clip to the threaded sleeve and engaging posts of the endplate clip into bores in the endplates; (6) assembling a friction ring onto the drive screw and inserting the drive screw through the rear plate; (7) threading the drive screw into the drive sleeve; and (8) securing the drive screw to the rear plate with a lock ring.
- According to yet another embodiment, a kit may include a plurality of implants of different sizes and configurations. The kit may further include one or more devices suitable for installing and/or removing the assemblies described herein, such as insertion devices or drivers; one or more removal devices; and other tools and devices, which may be suitable for surgery.
- The present embodiments will become more fully understood from the detailed description and the accompanying drawings, wherein:
-
FIGS. 1A-1C illustrate perspective views of an expandable implant in a collapsed position, expanded in width, and expanded in width and height, respectively, according to one embodiment; -
FIG. 2 shows an exploded view of the expandable implant ofFIGS. 1A-1C ; -
FIG. 3 show an exploded view of a retaining ring positionable on the drive shaft of the expandable implant to secure the drive shaft to the rear plate according to one embodiment; -
FIG. 4 shows an exploded view of a drive sleeve insertable into the front plate and configured to be retained by a lock nut according to one embodiment; -
FIG. 5 shows the rear plate attached to the drive screw, the drive sleeve attached to the front plate, and the drive screw threadedly engaged to the drive sleeve of the expandable implant according to one embodiment; -
FIG. 6 shows the top endplate assembled onto the actuator and the front ramp and a lower endplate configured to be placed onto the actuator and front ramp during assembly; -
FIG. 7 shows a cross-sectional view of the ramps of the upper and lower endplates engaged with the actuator and front ramp according to one embodiment; -
FIG. 8 shows the actuator of the side assemblies according to one embodiment; -
FIG. 9 shows the front ramp of the side assemblies according to one embodiment; -
FIGS. 10A-10C illustrate the actuators slidably engaged with the rear plate in a collapsed position and expanded in width, respectively, and a close-up view of the interaction between the actuator and the rear plate according to one embodiment; -
FIGS. 11A-11B illustrate the front ramps slidably engaged with the front plate in a collapsed position and expanded in width, respectively; -
FIG. 12 shows an endplate clip positioned around the drive sleeve configured to prevent the side assemblies from expanding in height until fully expanded in width according to one embodiment (the second set of endplates are omitted for clarity); -
FIGS. 13A-13D shows the endplate clip engaged and disengaged from the endplates, respectively (the second set of endplates and the drive sleeve are omitted for clarity); -
FIG. 14 is a rear view of the assembly expanded in width and height according to one embodiment; -
FIGS. 15A-15C shows the implant in a fully collapsed position, fully expanded in width, and fully expanded in width and height, respectively (one side assembly including one set of endplates, actuator, and front ramp are omitted for clarity); and -
FIGS. 16A-16C illustrate an expandable implant in a collapsed position, one side expanded in width, and both sides expanded in height, respectively, according to one embodiment. - Embodiments of the disclosure are generally directed to devices, systems, and methods for intervertebral fusion. Specifically, expandable implants are configured to increase the overall footprint size after being inserted into the disc space while also adjusting the lordosis and overall height. The expandable implants may include one or more side assemblies configured to expand in width and in height. In doing so, the expansion addresses sagittal balance correction and subsidence issues.
- A spinal fusion is typically employed to eliminate pain caused by the motion of degenerated disc material. Upon successful fusion, a fusion device becomes permanently fixed within the intervertebral disc space. The expandable fusion device may be positioned between adjacent vertebral bodies in a collapsed position. The expandable fusion device is configured to expand in width and subsequently in height. The fusion device engages the endplates of the adjacent vertebral bodies and, in the installed position, maintains desired intervertebral disc spacing and restores spinal stability, thereby facilitating an intervertebral fusion.
- Minimally invasive surgery (MIS) may be used to preserve muscular anatomy by only causing disruption where necessary. The benefit of the MIS surgical approach is that it can reduce post-operative pain and improve recovery time for patients. In one embodiment, the expandable fusion device can be configured to be placed down an endoscopic tube and into the surgical target site. By way of example, the surgical site may be an intervertebral disc space situated between two adjacent vertebrae. Although particularly suited for use in a transforaminal lumbar interbody fusion (TLIF), it will be readily appreciated by those skilled in the art that the implant may be employed in any number of suitable orthopedic approaches and procedures, including but not limited to, anterior, posterior, lateral, anterolateral, or posterolateral approaches to the lumbar spine, cervical spine, or thoracic spine, as well as any non-spine application, such as treatment of bone fractures and the like.
- Components of all of the devices disclosed herein may be manufactured of any suitable materials including metals (e.g., titanium), metal alloys (e.g., stainless steel, cobalt-chromium, and titanium alloys), ceramics, plastics, plastic composites, or polymeric materials (e.g., polyether ether ketone (PEEK), polyphenylene sulfone (PPSU), polysulfone (PSU), polycarbonate (PC), polyetherimide (PEI), polypropylene (PP), polyacetals, or mixtures or co-polymers thereof), and/or combinations thereof. In some embodiments, the devices may include radiolucent and/or radiopaque materials. The components can also be machined and/or manufactured using any suitable techniques (e.g., 3D printing).
- Turning now to the drawing, where like reference numerals refer to like elements,
FIGS. 1A-1C illustrate an expandable fusion device orimplant 10 according to one embodiment. Theexpandable fusion device 10 may include left and rightside portion assemblies device 10 and expand in height to correct disc height restoration, lordosis, and/or sagittal balance. Theimplant 10 may be suitable for a transforaminal lumbar interbody fusion (TLIF) through a posterior approach or other suitable surgical procedure. - The
expandable fusion device 10 extends along a central longitudinal axis A between front and rear ends of thedevice 10.FIG. 1A shows theexpandable fusion device 10 in a fully collapsed configuration with the left andright side portions FIG. 1B shows theexpandable fusion device 10 in an expanded configuration with the left andright side portions FIG. 1C shows the expandable fusion device in a fully expanded configuration with the left andright side portions right side portions expandable fusion device 10 placed into the disc space first, followed by the rear of theexpandable fusion device 10. These and other directional terms may be used herein for descriptive purposes and do not limit the orientation(s) in which the devices may be used. - With emphasis on the exploded view in
FIG. 2 , movement of the first half orleft side portion 12 and the second half orright side portion 14 of theimplant 10 is controllable by acentral drive screw 16 which is attached to a frontdistal plate 20 and rearproximal plate 22. Thedrive screw 16 pulls thedistal plate 20 towards theproximal plate 22 and pushes the left andright portions - The
central drive screw 16 is positioned into and threadedly engaged with acentral drive sleeve 18. Thecentral drive screw 16 andcentral drive sleeve 18 may be positioned along the central longitudinal axis A of thedevice 10. Thecentral drive sleeve 18 is attached to the front distal block orplate 20 and thecentral drive screw 16 is attached to a rear proximal block orplate 22. For example, thecentral drive sleeve 18 may be attached to the frontdistal plate 20 with alock nut 34 and thecentral drive screw 16 may be retained within the rearproximal plate 22 with a locking ring or retainingring 36. Thedrive screw 16 is configured to pull the frontdistal plate 20 towards the rearproximal plate 22, thereby pushing the left andright side portions horizontal ramps rear plates actuators 28, and thefront ramps 30, respectively. - Once the left and right
side portion assemblies distal plate 20 may continue to travel to allow for vertical expansion of the left andright side portions device 10. For example, the left and rightside portion assemblies lower endplates actuator 28, and afront ramp 30. Both of thefront ramps 30 are actuated when thecentral drive screw 16 is turned. Rotation of thedrive screw 16 pulls thefront ramps 30 toward theactuators 28, which then expands the top andbottom endplates vertical ramps endplates actuators 28, and thefront ramps 30, respectively. - As best seen in
FIG. 3 , thedrive screw 16 extends from aproximal end 40 to adistal end 42. Theproximal end 40 may include an enlarged head portion configured to be received in abore 44 defined through the rearproximal plate 22. Thebore 44 in therear plate 22 may be internally threaded to provide for a threaded connection to therear plate 22, for example, allowing for a rigid connection to an insertion instrument. Theproximal end 40 of thedrive screw 22 may define aninstrument recess 48 configured to receive an instrument, such as a driver, to rotate or actuate thedrive screw 16. Theinstrument recess 48 may include a tri-lobe, hex, star, or other suitable recess configured to engage with a driver instrument to apply torque to thedrive screw 16. Thedrive screw 16 may include a shaft with an exterior threadedportion 46 extending along its length. Thedrive screw 16 is receivable through thebore 44 in therear plate 22 such that the enlargedproximal head portion 40 of thedrive screw 16 is receivable in therear plate 22. Anoptional friction ring 38, such as a polyether ether ketone (PEEK) ring, may be assembled onto thedrive screw 16, for example, below the enlarged head, to increase friction or drag on thedrive screw 16 during rotation. - The
central drive screw 16 may be retained within the rearproximal plate 22 with retainingring 36. For example, the retainingring 36 may include a split ring with a plurality ofinner teeth 50 or various reliefs to allow the retainingring 36 to compress and enter thebore 44 of therear plate 22 and engage an internal groove in theplate 22. The retainingring 36 may include two slots, for example, to be engaged with an instrument to aid insertion and removal of the retainingring 36. When the retainingring 36 is positioned around thedrive screw 16 and within thebore 44 in therear plate 22, theteeth 50 are configured to engage with thecentral drive screw 16, thereby locking thescrew 16 in position in theplate 22. - The
rear plate 22 may include one ormore instrument slots 52 configured to be engaged by an instrument, such as an insertion instrument. For example, the top and bottom faces of therear plate 22 may each include a pair ofinstrument slots 52. Therear plate 22 may also define one or more side recesses 54 configured to receive a graft delivery device. For example, opposite sides of therear plate 22 may include two opposedsemi-circular recesses 54 configured to allow the graft delivery device to enter the central portion of theimplant 10 once fully expanded in width and/or height. Bone graft or similar bone growth inducing material can be introduced within and/or around thefusion device 10 to further promote and facilitate the intervertebral fusion. - The
rear plate 22 includes one ormore ramps 56 configured to interface withcorresponding ramps 90 on theactuators 28 of the left andright side portions rear plate 22, therear plate 22 may include a pair oframps 56 defined into each of the top and bottom surfaces of therear plate 22. Theramps 56 may be horizontal ramps aligned along one or more horizontal planes. For example, one of the pair oframps 56 may be positioned along one given horizontal plane lower or higher relative to theother ramp 56 along another given horizontal plane. In other words, eachramp 56 has a constant depth along its length such that oneramp 56 has a depth greater than theother ramp 56. Thehorizontal ramps 56 may be angled, diagonal, or slanted such that one end of theramp 56 starts at a side of therear plate 22 and extends toward the center back of therear plate 22 with theramps 56 leading toward one another. Thehorizontal ramps 56 may define female channels or grooves configured to receive the matingmale counterparts 90 of theactuators 28. It will be appreciated, however, that the female/male configurations may be reversed or may include other suitable ramp interactions, sliding features, or mating components to provide lateral expansion of the left and rideside portions - As best seen in
FIGS. 5 , the threadedshaft 46 of thedrive screw 16 may be receivable through the body of thedrive sleeve 18. Thedrive sleeve 18 may have a tubular body with aninner bore 60 that is internally threaded to allow for threaded engagement with the threadedshaft 46 of thedrive screw 16. As thedrive screw 16 is threaded into thedrive sleeve 18, actuation of thedrive screw 16 is configured to push or pull thefront plate 20. When thefront plate 20 is pulled toward therear plate 22, theimplant 10 expands in width and then height once fully assembled. - The
drive sleeve 18 may have an exterior threadedportion 62 at its distal end. The distal threadedportion 62 may fit into anopening 64 defined through the frontdistal plate 20. After being positioned through thebore 64 in thefront plate 20, thedrive sleeve 18 may be secured to the frontdistal plate 20 with thelock nut 34. Thelock nut 34 may include a ring with a central bore defining internal threads. Thedrive sleeve 18 may be secured to the frontdistal plate 20 by coupling the internally threadedlock nut 34 to the distal threadedportion 62 of thedrive sleeve 18. An outward face of thelock nut 34 may include one or more instrument recesses for engagement with an instrument to rotate thelock nut 34. - With emphasis on
FIG. 4 , thedrive sleeve 18 may be keyed to theopening 64 through thefront plate 20 with one ormore keying portions 66 configured to ensure the orientation of thedrive sleeve 18 relative to thefront plate 20. For example, the keyingportions 66 may include a pair of opposite wings on an outer surface of thesleeve 18 configured to mate with a corresponding keyway through theopening 64. Thewings 66 may extend between upper and lower portions of thesleeve 18 and may have a central vertical opening therebetween. Thewings 66 may include planar surfaces, curved surfaces, or other suitable surfaces configured to mate with thecorresponding opening 64. It will be appreciated that any suitable number, type, or configuration of keyingportions 66 may be selected to align thesleeve 18 with thefront plate 20. For example, the keyingportions 66 may include a dovetail interface, finger joint, pin(s), or other suitable keying feature(s) to ensure the desired orientation. The keyingportions 66 andopening 64 are aligned to lock thesleeve 18 from rotation. When thedrive screw 16 is rotated or actuated, thedrive sleeve 18 and attachedfront plate 20 are drawn toward therear plate 22, thereby providing for expansion of thedevice 10. - The
front plate 20 includes one ormore ramps 70 configured to interface withcorresponding ramps 104 on thefront ramps 30 of the left andright side portions ramps 56, ramps 70 may include horizontal ramps defining female channels or grooves configured to receive the matingmale counterparts 104 of thefront ramps 30. It will be appreciated, however, that the female/male configurations may be reversed or may include other suitable ramp interactions, sliding features, or mating components to provide lateral expansion of the left and rideside portions front plate 20 may include a first pair ofhorizontal ramps 70 defined into the top of thefront plate 20 and a second pair ofhorizontal ramps 70 defined into the bottom of thefront plate 20. Each of theramps 70 may be aligned along distinct horizontal planes. In this manner, eachramp 70 has a constant depth along its length such that one of the female horizontal ramps has a depth greater than the other female horizontal ramp. For example, afirst ramp 70 defined along the top of thefront plate 20 may be positioned along one given horizontal plane lower or higher relative to theother ramp 70 defined along the top of thefront plate 20. Thehorizontal ramps 70 may be angled, diagonal, or slanted such that one end of eachramp 70 begins at a side of thefront plate 20 and extend centrally in a direction towards thedrive sleeve 18 with theramps 70 leading toward one another. - With emphasis on
FIGS. 6 and 7 , the left and rightside portion assemblies lower endplates expandable fusion device 10. The upper andlower endplates upper endplate 24, the discussion herein applies equally to thelower endplate 26. Theupper endplate 24 includes an upper or outer facingsurface 74 configured to interface with the vertebral endplate(s) of the adjacent vertebral bodies when implanted in the disc space. Theouter surface 74 may include a plurality of teeth, ridges, roughened surfaces, keels, gripping or purchasing projections, or other friction increasing elements configured to retain thedevice 10 in the disc space. For example, theendplates - The
upper endplate 24 includes a lower orinner facing surface 76 and one ormore side walls 78 defining one ormore ramps 80 configured to interface withcorresponding ramps 92 on theactuator 28 andfront ramp 30. For example, theupper endplate 24 may define at least threeramps 80 along theinner side wall 78 of theendplate 24. Theramps 80 may be vertical ramps aligned along one or more vertical planes. In one embodiment, all threevertical ramps 80 may be aligned along the same plane. Although vertically-oriented, thevertical ramps 80 may be angled, diagonal, or sloped to increase the vertical height of theendplates vertical ramps 80 interfaced with theactuator 28 may be angled in one direction and a thirdvertical ramp 80 interfaced with thefront ramp 30 may be angled in an opposite direction. For example, the distal-mostvertical ramp 80, nearfront ramp 30, may be sloped such that it points toward thefront ramp 30 as it extends along theside wall 78 from theinner surface 76 toward theouter surface 74. Similarly, the proximal-mostvertical ramp 80, near theactuator 28, and centrally locatedvertical ramp 80, may be sloped such that they point toward theactuator 28 as they extend along theside wall 78 from theinner surface 76 toward theouter surface 74. The proximal-mostvertical ramp 80 and centralvertical ramp 80 may be aligned in parallel with the same degree of slope. Thevertical ramps 80 may define female channels or grooves configured to receive the matingmale counterparts actuator 28 andfront ramp 30. It will be appreciated that the female/male configurations may be reversed or may include other suitable ramp interactions, sliding features, or mating components to provide vertical expansion of the left and rideside portions - One or
more openings 82 may extend vertically through the body of theendplate 24. In the collapsed position, as shown inFIG. 1A ,portions 92 of theactuators 28 may be received through theopenings 82. Similarly, when expanded in width, as shown inFIG. 1B , theramps 92 of theactuators 28 are receivable through theopenings 82 in theendplates FIG. 1C , theopenings 82 may be open and free to receive bone-graft or other suitable bone forming material. One or more openings or bores 84 may extend horizontally through thesidewalls 78 of theendplate 72, 74. The through bores 84 are configured to receiveendplate clip 32 to prevent vertical expansion until horizontal expansion is complete. - The left and right
side portion assemblies second actuators 28 positioned between the upper andlower endplates right side portions FIG. 8 , theactuator 28 may include a body extending along a central axis Al from aproximal end 86 to adistal end 88. Central axis Al may be generally parallel with central longitudinal axis A. Theproximal end 86 may define one or morehorizontal ramps 90 configured to engage with thehorizontal ramps 56 of therear plate 22. Theactuator 28 may define a pair of top and bottomhorizontal ramps 90 pointing inwardly toward one another. Thehorizontal ramps 90 may have an angled, diagonal, or slanted surface in a manner complimentary to theramps 56 of therear plate 22. In particular, thehorizontal ramps 90 may define male projections configured to enter thefemale counterparts 56 of therear plate 22. - The
actuator 28 includes a plurality oframps 92 configured to engage with theendplates actuator 28 may define a plurality ofvertical ramps 92 configured to engage with thevertical ramps 80 of theendplates actuator 28 may define a first pair ofvertical ramps 92 pointing upwardly toward theproximal end 86 or downwardly toward thedistal end 88 and a second pair ofvertical ramps 92 pointing upwardly toward thedistal end 88 or downwardly toward theproximal end 86 of theactuator 28. Thevertical ramps 92 may have an angled, diagonal, or sloped surface in a manner complimentary to theramps 80 of theendplates vertical ramps 92 may define male projections configured to enter thefemale counterparts 80 of theendplates - As shown in
FIG. 9 , the left andright side portions front ramp 30 configured to expand the distal or front ends of the upper andlower endplates front ramp 30 may include a body extending from aproximal end 94 to adistal end 96. Theproximal end 94 may define one or morevertical ramps 102 configured to engage with thevertical ramps 80 of theendplates front ramp 30 may define a firstvertical ramp 102 pointing downwardly toward theproximal end 94 and a secondvertical ramp 102 pointing upwardly toward theproximal end 94 of thefront ramp 30. Thevertical ramps 102 may have an angled, diagonal, or sloped surface in a manner complimentary to theramps 80 of theendplates vertical ramps 102 may define male projections configured to enter thefemale counterparts 80 of theendplates - The
distal end 96 of thefront ramp 30 may define one or morehorizontal ramps 104 configured to engage with thehorizontal ramps 70 of thefront plate 20. Thefront ramp 30 may define a pair of top and bottomhorizontal ramps 104 separated by a gap and pointing inwardly toward one another. Thehorizontal ramps 104 may have an angled, diagonal, or slanted surface in a manner complimentary to theramps 70 of thefront plate 20. In particular, thehorizontal ramps 104 may define male projections configured to enter thefemale counterparts 70 of thefront plate 20. -
FIGS. 10A-10C show theactuators 28 slidably engaged with therear plate 22 in collapsed and expanded positions, respectively. The actuators 29 slide onto therear plate 22 by aligning keying features that control expansion. InFIG. 10A , theactuators 28 are engaged with therear plate 22 and collapsed onto one another. A recessedsurface 106 on top of oneactuator 28 sized and dimensioned to receive theother actuator 28 permits theactuators 28 to nest together, thereby providing a small footprint for insertion. It will be appreciated that a corresponding recessedsurface 106 may be provided on the bottom of theopposite actuator 28 to provide for a complimentary fit. As best seen inFIG. 10C , onehorizontal ramp 56 is positioned deeper than anotherhorizontal ramp 56 to further facilitate this nesting configuration of theadjacent actuators 28. Thehorizontal ramps 90 of theactuators 28 slidably interface with thehorizontal ramps 56 of therear plate 22, thereby permitting lateral movement of the left andright side assemblies actuators 28 may have features that engage with the matingrear plate 22 that limit the amount of translation while expanding in width. When expanded laterally in width, theactuators 28 slide outward and away from one another, thereby increasing the width of theimplant 10.FIG. 10B shows theactuators 28 fully expanded in width. - Front ramps 30 and
front plate 20 utilize a similar sliding interface asactuators 28 andrear plate 22.FIGS. 11A-11B show thefront ramps 30 slidably engaged with thefront plate 20 in collapsed and expanded positions, respectively. Front ramps 30 slide onto thefront plate 20 by aligning keying features that control expansion. InFIG. 11A , thefront ramps 30 are engaged with thefront plate 20 and collapsed onto one another. A recessedsurface 108 on top of onefront ramp 30 sized and dimensioned to receive the otherfront ramp 30 permits thefront ramps 30 to nest together, thereby providing a small footprint for insertion. It will be appreciated that a corresponding recessedsurface 108 may be provided on the bottom of theopposite front ramp 30 to provide for a complimentary fit. Similar torear ramp 22, onehorizontal ramp 70 may be positioned at a depth greater than the otherhorizontal ramp 70 to further facilitate this nesting configuration of thefront ramps 30. Thehorizontal ramps 104 of thefront ramps 20 slidably interface with thehorizontal ramps 70 of thefront plate 20. The front ramps 20 may have features that engage with themating front plate 20 that limit the amount of translation while expanding in width. InFIG. 11B , theactuators 28 are fully expanded in width. When expanded in width, thefront ramps 20 slide outward and away from one another, thereby increasing the overall width of theimplant 10. - Turning now to
FIGS. 12 and 13A-13D , theimplant assembly 10 may includeendplate clip 32 to keep the assembly from expanding in height until the full width expansion is achieved. When the assembly is fully contracted, theendplate clip 32 is engaged into all of theendplates endplate clip 32 is no longer engaged withendplates assembly 10 to also expand in height. - As best seen in
FIG. 12 , theendplate clip 32 may include aring 112 configured to fit over thedrive sleeve 18 and a plurality ofposts 114 configured to engage the upper andlower endplates ring 112 may include a full ring defining a central bore sized and dimensioned to snuggly fit around the tubular body of thedrive sleeve 18. Theposts 114 extend from thering 112 and terminate at one or more free ends 116. For example, afirst post 114 may be positioned above thering 112 with two opposed free ends 116 extending into the left and rightupper endplates 24, respectively, and asecond post 114 may be positioned below thering 112 with two opposed free ends 116 extending into the left and rightlower endplates 26, respectively. The twoposts 114 may be aligned in parallel, for example, horizontally in line with the upper andlower endplates separate posts 114 may extend from thering 112 and terminate atfree ends 116 each receivable in therespective endplates ring 112 may be substituted with another suitable attachment mechanism to thedrive sleeve 18 and any suitable number and configuration ofposts 114 or other configurations for theendplate clip 32 may be used to secure theendplates -
FIGS. 13A and 13C show theendplate clip 32 and one set ofendplates 24, 26 (the opposite set of endplates are omitted for clarity) before the left andright side assemblies ends 116 of theposts 114 are received in thebores 84 through theside wall 78 of theendplates posts 114 are positioned inbores 84, theendplates FIGS. 13B and 13D show theendplate clip 32 disengaged from theendplates endplates ends 116 of theposts 114 are released from thebores 84. Theendplates FIG. 14 shows a rear view of the assembledimplant 10 fully expanded in width and in height. Therear plate 22 definesrecesses 54 and theactuators 28 allow entry to a central portion of theimplant 10 to allow delivery of graft material into theimplant 10 once fully expanded in width. -
FIGS. 15A-15C show theimplant 10 with the right side assembly 14 (one set ofendplates actuator 28, andfront ramp 30 and hidden for clarity). InFIG. 15A , theimplant 10 is fully collapsed and may be inserted into a disc space, for example, through a posterior approach. Theimplant 10 may be attached to a multi-component instrument, for example, and a driving instrument may be used to engage therecess 48 in thedrive screw 16 with a compatible drive feature. When thedrive screw 16 is rotated, thescrew 16 pulls and translates thescrew sleeve 18, attachedfront plate 20, and attachedfront ramps 30 proximally. When doing so, it will force thefront ramps 30 to translate outward and expand in width. Height expansion does not occur yet because theendplate clip 32 holds theendplates FIG. 15B shows theimplant 10 fully expanded in width. Once thefront ramps 30 are translated outward and full width expansion occurs, thefront ramps 30 continue to translate with thescrew sleeve 18 and attachedfront plate 20 proximally, thereby forcing the ramp features 80, 92, 102 of theactuators 28, front ramps 30, andendplates endplates FIG. 15C show theimplant 10 fully expanded in width and in height. The amount of height of expansion on the left andright side assemblies implant 10 is expanded in width for an increased footprint to aid in overall stability and theimplant 20 is adjusted in lordosis and height for a precise patient fit. - In one embodiment, the
implant 10 may be assembled as follows. The twofront ramps 30 are placed ontofront plate 20 by aligning the ramp/slidingfeatures actuators 28 are placed ontorear plate 22 by aligning the ramp/slidingfeatures right sides lower endplate 26 is placed ontoactuator 28. Theupper endplate 24 is placed ontoactuator 28. Thefront ramp 30 is placed into both the lower andupper endplates upper endplate 24 is placed onto the actuator and thefront ramp 20 is placed onto theupper endplate 24. Then thelower endplate 26 is placed onto both theactuator 28 and thefront ramp 20 while ensuring allramps sleeve 18 is inserted into thefront plate 20 and secured with thelock nut 34. Theendplate clip 32 is slid onto the threadedsleeve 18 to engage fourposts 114 into thebores 84 of theendplates PEEK ring 38 is assembled onto thedrive screw 16 which are then inserted through therear plate 22, threaded intodrive sleeve 18, and retained by thelock ring 36. - Turning now to
FIGS. 16A-16C , expandable fusion device orimplant 210 is similar to implant 10 except only one of theside portion assemblies 212 is configured to expand in width and the other 214 remains stationary.Implant 210 includes a first half orleft side portion 212, which is moveable to expand in width and a second half orright side portion 214, which does not expand in width. Both of the left andright side portions side portion 212 is shown as moveable andside portion 214 as stationary, it will be appreciated that the configuration may be reversed. - The left and
right assemblies central drive screw 216 which is attached to adrive sleeve 218, a frontdistal plate 220 and a rearproximal plate 222. Thedrive screw 216 pulls thedistal plate 220 towards theproximal plate 222 and pushes only oneside portion 212 outwards with the use of ramps/slide mechanisms implant 10, therear plate 222 includes a femalehorizontal ramp 256 slidably engaged with a malehorizontal ramp 290 on theactuator 228 and thefront plate 220 includes a femalehorizontal ramp 270 slidably engaged with a malehorizontal ramp 304 on thefront ramp 230. In this embodiment, the front andrear plates horizontal ramp plates single actuator 228 andfront ramp 230, respectively. - Once the
single side 212 is fully expanded in width, the frontdistal plate 220 continues to travel toward theproximal plate 222 as thedrive screw 216 is rotated. Theimplant 210 may include an endplate clip, similar toendplate clip 32, with posts to engage only themoveable side 212. Similar to implant 10, thesingle side 212 that expands outwards includes upper andlower endplates actuator 228, andfront ramp 230, which is configured to expand in height via internal vertical ramps. The frontdistal plate 220 along with thesingle front ramp 230 is actuated while thedrive screw 216 is turned. This actuation pulls thefront plate 220 andfront ramp 230 toward theproximal plate 222 and thesingle actuator 228, which then expands the top andbottom endplates front ramp 230 andactuator 228. Thesingle side 214 that does not expand laterally outward has incorporated the front ramp features into the frontdistal plate 220 and the actuator features into the rearproximal plate 222. Thus, thenon-expanding side 214 includes upper andlower endplates rear plates distal plate 220 includes one or more vertical ramps, similar toramps 102, configured to slidably interface with the vertical ramps of theendplates rear plate 222 has an enlarged body with one or more vertical ramps, similar toramps 92, configured to slidably interface with the vertical ramps of theendplates 224, 266. This allows theendplates non-width expanding side 214 to also expand in height. The amount of height of expansion on the expandingside 212 andnon-expanding side 214 may be the same or different. - Although the invention has been described in detail and with reference to specific embodiments, it will be apparent to one skilled in the art that various changes and modifications can be made without departing from the spirit and scope of the invention. Thus, it is intended that the invention covers the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents. It is expressly intended, for example, that all components of the various devices disclosed above may be combined or modified in any suitable configuration.
Claims (20)
1. An expandable intervertebral implant comprising:
front and rear plates;
a central drive screw threadedly engaged with a drive sleeve, the central drive screw retained in the rear plate and the drive sleeve retained in the front plate;
left and right side portion assemblies each including upper and lower endplates, an actuator, and a front ramp; and
an endplate clip positioned around the drive sleeve to prevent expansion of the upper and lower endplates in height until the left and right side portion assemblies are fully expanded in width.
2. The expandable intervertebral implant of claim 1 , wherein when the drive screw is rotated, the implant expands in width and once the upper and lower endplates are released from the endplate clip, then the implant expands in height.
3. The expandable intervertebral implant of claim 1 , wherein the endplate clip includes a ring with a plurality of posts configured to engage the upper and lower endplates.
4. The expandable intervertebral implant of claim 3 , wherein the ring includes a full ring defining a central bore sized and dimensioned to snuggly fit around the drive sleeve.
5. The expandable intervertebral implant of claim 3 , wherein the posts extend from the ring and terminate at one or more free ends.
6. The expandable intervertebral implant of claim 5 , wherein before the implant is fully expanded, the free ends of the posts are received in bores through a side wall of the endplates, thereby preventing any expansion in height.
7. The expandable intervertebral implant of claim 6 , wherein once fully expanded in width, the endplates move outward and away from one another and the free ends of the posts are released from the bores, thereby allowing the upper and lower endplates to expand in height.
8. The expandable intervertebral implant of claim 3 , wherein a first post is positioned above the ring with two opposed free ends extending into the upper endplates, respectively, and a second post is positioned below the ring with two opposed free ends extending into the lower endplates, respectively.
9. The expandable intervertebral implant of claim 8 , wherein the two posts are aligned in parallel.
10. An expandable intervertebral implant comprising:
a front plate having at least one ramp and a rear plate having at least one ramp;
a central drive screw threadedly engaged with a drive sleeve, the central drive screw retained in the rear plate and the drive sleeve retained in the front plate;
a left side portion assembly and a right side portion assembly, wherein the left and right side portion assemblies each include an upper endplate, a lower endplate, an actuator, and a front ramp, wherein the actuator includes a ramp slidably engaged with the ramp of the rear plate, and the front ramp includes a ramp slidably engaged with the ramp of the rear plate; and
an endplate clip positioned between the drive sleeve and the upper and lower endplates,
wherein rotation of the drive screw moves the front plate toward the rear plate and the ramp of the actuator slides across the ramp of the rear plate, the ramp of the front ramp slides across the ramp of the front plate, thereby expanding a width of the implant, and the endplate clip prevents expansion of the upper and lower endplates in height until the left and right side portion assemblies are fully expanded in width.
11. The expandable intervertebral implant of claim 10 , wherein the drive sleeve includes a tubular body with an internally threaded bore, and the central drive screw includes an externally threaded shaft allowing for threaded engagement with the internally threaded bore of the drive sleeve.
12. The expandable intervertebral implant of claim 11 , wherein the endplate clip includes a ring fitted over the tubular body of the drive sleeve with a plurality of outwardly extending posts configured to engage the upper and lower endplates.
13. The expandable intervertebral implant of claim 12 , wherein the endplate clip includes a first post affixed to a top of the ring and a second post affixed to a bottom of the ring.
14. The expandable intervertebral implant of claim 13 , wherein the first post terminates at first and second free ends configured to engage the upper endplates and the second post terminates at third and fourth free ends configured to engage the lower endplates.
15. The expandable intervertebral implant of claim 13 , wherein the first and second posts are horizontally aligned with the upper and lower endplates, respectively.
16. The expandable intervertebral implant of claim 13 , wherein before the implant is fully expanded, the free ends of the posts are received in bores through a side wall of the endplates, thereby preventing any expansion in height.
17. An expandable intervertebral implant comprising:
front and rear plates each having horizontal ramps;
a central drive screw for moving the front plate relative to the rear plate;
an expandable assembly including an upper endplate, a lower endplate, an actuator, and a front ramp, wherein the upper and lower endplates include vertical ramps, the actuator includes horizontal ramps engaged with the horizontal ramps of the rear plate and vertical ramps engaged with the vertical ramps of the upper and lower endplates, and the front ramp having horizontal ramps engaged with the horizontal ramps of the front plate and vertical ramps interfacing with the vertical ramps of the upper and lower endplates; and
an endplate clip attached to the drive sleeve to prevent expansion of the upper and lower endplates in height until the expandable assembly is fully expanded in width.
18. The expandable intervertebral implant of claim 17 , wherein the endplate clip includes one or more posts receivable in corresponding bores in the upper and lower endplates.
19. The expandable intervertebral implant of claim 18 , wherein the endplate clip only permits lateral expansion of the expandable assembly until the posts disengage from the bores in the upper and lower endplates.
20. The expandable intervertebral implant of claim 18 , wherein a first post is receivable in the bore in the upper endplate and a second post is receivable in the bore in the lower endplate, and the first and second posts are aligned in parallel.
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US17/841,705 US20230404771A1 (en) | 2022-06-15 | 2022-06-16 | Expandable footprint implant |
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US17/841,705 US20230404771A1 (en) | 2022-06-15 | 2022-06-16 | Expandable footprint implant |
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GB8620937D0 (en) | 1986-08-29 | 1986-10-08 | Shepperd J A N | Spinal implant |
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2022
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- 2022-06-16 US US17/841,705 patent/US20230404771A1/en active Pending
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US12011364B2 (en) | 2024-06-18 |
EP4292570A1 (en) | 2023-12-20 |
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