US20210251776A1 - Intervertebral implant device with lordotic expansion - Google Patents

Abstract

An expandable interbody fusion implant device has a frame, two ramp assemblies, a threaded drive shaft and at least one base plate, preferably two. The frame has a first lateral side and a second lateral side and a distal end and a proximal end. Each ramp assembly has a translating ramp with a threaded opening, a first pivoting hinged ramp and a second pivoting hinged ramp. Each base plate is hinged to a first lateral side of the frame. Each base plate is hinged to the distal ramp assembly and the proximal ramp assembly at an end of one of said pivoting hinged ramps of each ramp assembly. The drive shaft has a distal drive shaft component having threads for translating the distal ramp assembly and a proximal drive shaft component having threads for translating the proximal ramp assembly.

Description

RELATED APPLICATIONS
• This application is a continuation of U.S. patent application Ser. No. 16/158,622 filed Oct. 12, 2018, which is a continuation of U.S. patent application Ser. No. 15/938,083 filed Mar. 28, 2018, now U.S. Pat. No. 10,166,117 issued Jan. 1, 2019, which is a divisional of U.S. patent application Ser. No. 15/635,657 filed Jun. 28, 2017, now U.S. Pat. No. 9,962,272 issued May 8, 2018, the disclosure of each of which is incorporated by reference herein in its entirety
TECHNICAL FIELD
• The present disclosure relates to an expandable interbody fusion implant device with lordotic expansion and contraction for implantation between vertebral bodies.
BACKGROUND OF THE INVENTION
• Spinal stabilization can be achieved by providing an interbody implant. Some of these implants are bone, PEEK (polyether ether ketone), solid titanium or similar non-bone implant material and some are hollow implants that provide for inclusion of a bone graft or other suitable material to facilitate bony union of the vertebrae.
• Interbody implants can be inserted into the disc space through an anterior, posterior or lateral approach. In some systems, the implants are inserted into a bore formed between adjacent vertebral bodies in the cortical endplates and can extend into the cancellous bone deep to the cortical endplates. Implant size is typically selected such that the implants force the vertebrae apart to cause tensing of the vertebral annulus and other soft tissue structures surrounding the joint space. Tensing the soft tissues surrounding the joint space results in the vertebrae exerting compressive forces on the implant to retain the implant in place.
• It has been found desirable to keep the surgical opening as small as practical while still having sufficient room to insert the implant device and the end of an elongated tool or insertion instrument.
• Advantageously, if the implant size could be reduced further that would allow the surgical opening to be reduced; however, once implanted the device needs to be expandable to provide sufficient spacing of the vertebrae.
• A whole class of expandable interbody implant devices have been developed for this purpose. Some prior art devices use hydraulic expansion or inflatable balloons. Some devices are stackable elements piled on themselves to raise their height. Some use rotatable screw jack designs. Some are wedges that have a fixed hinged end and an opposite expandable end. Most of the rotatable expandable devices using screw threads require the device to be round cylinders or posts.
• One of the problems of such devices is the amount of post insertion manipulation required to reach a fully expanded properly space height is tedious and time consuming. Secondly, additional set screws or locking elements are often required to keep the device at its proper size. Thirdly, the devices of a circular shape are not the best fit for the adjacent vertebrae being spaced. Fourth, most of the devices have the internal space occupied with mechanisms limiting the amount of bone growth material available for packing the implants.
• The wedge type implants generally contact the bone on an angle and expandable wedges when expanded simply expand on an angle not parallel to the vertebrae surface. This places localized high loading between the vertebrae because the wedge surfaces are not parallel to the vertebrae.
• In some cases of vertebral misalignment, a controlled angulation of the implant device can be very beneficial to correct a pre-existing condition. Accordingly, in those cases having a wedge shape at a fixed angulation would mean the manufacturer would be required to make many devices with pre-set angles to select from. This simply is cost prohibitive.
• Previous ramped methods of expansion limit the range of expansion height, and therefore maximum angle, of the implant by using ramped surfaces directly onto the base plate which contacts the endplate of the vertebral body. Other expansion methods include cylindrical gear drive features, hinged linkages, and cams/ramps forcing base plate(s) apart through plastic deformation of the material. The cylindrical gear drive features limit the amount of bone graft space available within the interbody cage to promote fusion, unsupported hinged linkages reduce load bearing surface area and negatively affect the expansion strength and overall strength of the interbody cage. Other devices use material deformation which limits the amount of expansion capability and reduces the structural integrity of the interbody cage. The present invention overcomes all these deficiencies.
• The present invention provides a device that can be expanded angularly to allow the surgeon to choose the ideal lordotic angle he wants to use to correct the spinal alignment.
• These and other limitations in the prior art have been corrected and solved by the present invention as disclosed herein.
SUMMARY OF THE INVENTION
• An expandable interbody fusion implant device has a frame, two ramp assemblies, a threaded drive shaft and at least one base plate, preferably two. The frame has a first lateral side and a second lateral side and a distal end and a proximal end. The two ramp assemblies include a distal ramp assembly and a proximal ramp assembly. Each ramp assembly has a translating ramp with a threaded opening, a first pivoting hinged ramp and a second pivoting hinged ramp. The at least one, preferably two overlying base plates are disposed between the distal end and the proximal end of the frame. Each base plate is hinged to a first lateral side of the frame. A first base plate overlies a second base plate. Each base plate is hinged to the distal ramp assembly and the proximal ramp assembly at an end of one of said pivoting hinged ramps of each ramp assembly. The threaded drive shaft is pinned to the proximal end of the frame. The drive shaft has a distal drive shaft component having threads for translating the distal ramp assembly and a proximal drive shaft component having threads for translating the proximal ramp assembly. Each drive shaft component is coupled to the other. The proximal drive shaft component is affixed to the frame at the proximal end of the frame.
• Rotation of the drive shaft drives the distal ramp assembly and proximal ramp assembly simultaneously in opposite directions to selectively expand or contract a distance between the two base plates laterally relative the second lateral side of the frame. This simultaneous rotation of both distal and proximal drive shaft components drives the distal and proximal ramps selectively expands or contracts a distance between both first and second base plates to a selected inclination of the first and second base plates relative to the frame over a range of lordotic angles.
• Each translating ramp has an exterior lift surface to guide and support the pivoting hinged ramps during expansion or contraction of the base plates. During expansion of the base plates the distal ramp assembly moves directionally toward the distal end of the frame on rotation of the distal drive shaft component as the proximal ramp assembly simultaneously moves directionally toward the proximal end of the frame on rotation of the proximal drive shaft component, increasing the inclination of the base plates relative to the frame. This device stops expansion when each translating ramp contacts the distal and proximal wall of the frame. Each pivoting hinged ramp has a bearing support surface configured to slide on the exterior lift surface of the translating ramp. Each pivoting hinged ramp bearing support surface is complimentary to the exterior lift surface, the complimentary surface of each being inclined with a sloped flat feature.
• Each translating ramp has a pair of opposing sides, each side has a pair of guide channels or grooves configured to receive a projecting rail positioned inside the frame along each first and second lateral side of the frame. Each base plate has pockets to which the pivoting hinged ramps are pinned and each translating ramp has a hinge guide channel or hinge guide groove for receiving and guiding one of the pivoting hinged ramps. Each pivoting hinged ramp has a lateral side keyed into the hinge guide channel or hinge guide groove.
• The distal end of the frame has a tapered end configured to facilitate insertion between vertebral bodies. The proximal end of the frame has an opening for receiving an end of the threaded drive shaft, and further has the first lateral side with slotted channels to receive a hinge pin fixed to the first or second base plates, the hinge pins configured to allow the base plates to pivot relative to the frame during expansion or contraction.
• In still another embodiment, the first and second base plates each have at the proximal end an end plate with a fastener opening for securing the implant to a vertebral body. Each end plate is integral to and movable with the base plate during expansion or contraction. Each end plate further has a locking tab attached to the end plate, the locking tab being rotatable to cover a portion of the fastener from loosening after being affixed to a vertebral body. Preferably, the base plates have a laterally inclined outer surface configured to match or mimic a lordotic curvature of the lumbar spine.
BRIEF DESCRIPTION OF THE DRAWINGS
• The invention will be described by way of example and with reference to the accompanying drawings in which:
• FIG. 1 is a perspective view of the expandable implant device of a preferred embodiment made in accordance with the present invention shown in a contracted non-expanded position.
• FIG. 1A is an alternative embodiment of the present invention without end plates and fasteners shown in a contracted position.
• FIG. 2 is a side view of the expandable implant device taken fromFIG. 1.
• FIG. 3A is a perspective view of the device ofFIG. 1 shown expanded.
• FIG. 3B is the side view taken fromFIG. 3A with threaded fasteners installed in the proximal end of each first and second base plate.
• FIG. 4A is a proximal end view of the device ofFIG. 1 shown contracted without fasteners.
• FIG. 4B is a proximal end view taken fromFIG. 4A with fasteners.
• FIG. 4C is a proximal end view taken fromFIG. 4B with threaded fasteners installed in the proximal end of each first and second base plate with the device shown expanded.
• FIG. 5A is a perspective exploded view of the device ofFIG. 1 shown without the fasteners.
• FIG. 5B is a side view of the device taken fromFIG. 5A showing the frame and the drive shaft and translating ramp assemblies assembled.
• FIG. 5C is a side view taken of the proximal end of the drive shaft and proximal translating ramp and the frame.
• FIG. 5D is an exploded perspective view of the device ofFIG. 5A with the proximal portion of the drive shaft prior installed in the proximal end of the frame and the pins not yet installed and the distal drive shaft component and distal ramp shown above the frame.
• FIG. 6A is an exploded side view of the device of the present invention as a final assembly step showing hinge pins for securing the base plates to the frame.
• FIG. 7A is a side cross-sectional view of the device of the present invention with the drive shaft rotated to a fully contracted position.
• FIG. 7B is a side cross-sectional view of the device of the present invention with the drive shaft expanded.
• FIG. 8A is an end cross-sectional view of the device of the present invention with the ramp assembly shown with drive shaft expanded.
• FIGS. 9A, 9B and 9C are isometric views of the alternative embodiment device with no end plates shown contracted partially expanded and fully expanded.
• FIGS. 10A and 10B are side views of the device of1A shown contracted and fully expanded, respectively.
• FIGS. 11A and 11B are cross sectional views of the device ofFIG. 1A taken fromFIGS. 10A and 10B, 11A from10A and11B from10B.
• FIGS. 12A and 12B are distal end views,12A shown contracted and12B shown expanded.
• FIGS. 13A and 13B are proximal end views,13A shown contracted and13B shown expanded.
• FIGS. 14A and 14B are top views,14A shown contracted and14B shown expanded.
• FIG. 15A is a cross-sectional view of the device of the present invention in a contracted position.
• FIG. 15B is a cross-sectional view of the device of the present invention in an expanded position.
• FIG. 16 is a side view of a third embodiment of the invention wherein only a single hinge base plate is shown attached to the frame and the frame has a fixation end plate at the proximal end.
• FIG. 17 is an exemplary illustration of the device implanted between two adjacent vertebral bodies.
DETAILED DESCRIPTION OF THE INVENTION
• The purpose of the present invention is to promote spinal fusion with distraction and/or alignment correction of vertebral bodies by implanting theinterbody device10 and expanding thebase plates20,40 to the appropriate height and angle by controlling fine height adjustment of one side of the implant (anterior side), increasing the lordotic angle. The optional incorporated fixation end plates which expand along with thebase plates20,40 may be used as inFIG. 1 or may not be used as inFIG. 1A to accept a screw or fastener and lock for fixation of the interbody.
• The intervertebral implant device with lordotic expansion of the present invention, hereinafter described as an expandable interbodyfusion implant device10, has aframe60, two ramp assemblies,34A,35A and twooverlying base plates20,40 driven by a threadeddrive shaft50 having two coupleddrive shaft components51,52; as illustrated inFIGS. 1 and 1A. As illustrated in the preferred embodiment ofFIG. 1, eachbase plate20,40 has afixation end plate21,41 with anopening25,45 for receiving a threadedfastener100 for attachment to a vertebral body. A lockingtab70 is provided. InFIG. 1A, analternative embodiment10A of thedevice10 is illustrated withoutfixation end plates21,41 or threadedfasteners100. In all other respects thedevices10,10A are the same.
• With reference toFIGS. 1 and 2, thedevice10,10A shows theframe60 having adistal end62 and aproximal end61. The tworamp assemblies34A,35A include a distal translatingramp35 and a proximal translatingramp34 respectively, and further have a first pivoting hingedramp31 and a second pivoting hingedramp33 held bypins85 in pockets or recesses in eachbase plate20,40. The twooverlying base plates20,40 are disposed between thedistal end62 and theproximal end61. Thefirst base plate20 overlies thesecond base plate40 with theframe60 interposed between. Eachbase plate20,40 is hinged to adistal ramp assembly35A and theproximal ramp assembly34A at an end of one of the said pivoting hingedramps31,33 of eachramp assembly34A,35A by the pivoting hinged ramps held bypins85 in the pockets or recesses of each base plate and further hinged withpins82 along a first lateral side of theframe60. Eachbase plate20,40 being pivotally moveable about the hinge of theframe60. Thedrive shaft50 include a distaldrive shaft component52 for translating thedistal ramp assembly35A and a proximaldrive shaft component51 for translating theproximal ramp assembly34A. Thedrive shaft50 is affixed to theframe60 at the proximal end with pins53.
• As shown inFIGS. 1 and 2, theimplant device10 is shown in a fully contracted position, this position is most suitable for insertion as it provides the lowest height between the opposingbase plates20,40. As shown, thedistal end62 has a chamfered leading end surface further reducing the cross section as it enters between the intervertebral spaces providing a nice leading nose end for insertion. At the proximal end of theimplant device10, eachbase plate20,40 respectively hasfixation end plates21 and41. Thesefixation end plates21,41 each are provided with a throughhole25 for receiving a threadedfastener100.
• With reference toFIGS. 3A and 3B, theimplant device10 is shown where the threadeddrive shaft50 has been rotated, the distaldrive shaft component52 hasthreads59 engagethreads95 in the translatingramp35 that cause thedistal ramp assembly35A to be moved towards the distal end of theframe62. When this occurs, the translatingramp35 of thedistal ramp assembly35A moves the pivoting hingedramps31 and33 along an outer surface of the translatingramp35 following the contour of the outer surface. Simultaneously, when thisdrive shaft50 is rotationally driven it rotates the proximaldrive shaft component51 causing thebase plates20,40 both to be expanded increased in height from the contracted state to an expanded state as thebase plates20,40 pivot. Thedrive shaft50 is assembled from twocomponents51,52 and theproximal component51 is pinned withpins53 into theframe60 at the proximal end of the interbody to maintain positioning and prevent translation. Thedrive shaft50 threads into both the distal translating/expandingramp35 and the proximal translating/expandingramp34 to drive both ramp assemblies simultaneously. To accomplish this movement, the distaldrive shaft component52 hasthreads59 opposite to the proximaldrive shaft component51threads58, one thread being left handed the other thread right handed.
• This increase in height can occur in small increments anywhere dependent on the amount of the rotation of thedrive shaft50 and this rotation achieves a maximum level when the translatingramp34,35 contacts the distal or proximal wall of theframe60. In the fully expanded condition, the lateral side of each base plate is shown elevated relative to the frame. This can best be seen inFIG. 3B from a side view or4C from a front view. Threadedfasteners100 can be inserted through the throughholes25 in both the firstfixation end plate21 and the secondfixation end plate41 of thefirst base plate20 and thesecond base plate40 respectively at any selected angle or expansion.FIG. 4A best shows the throughholes25 without thefasteners100.FIGS. 4B and 4C show the end view of thedevice10 in the contracted and fully expanded positions.
• With reference toFIGS. 5A-5D, various exploded views of the components of theimplant device10 are shown. With reference toFIGS. 5A, 5B theramp assemblies34A,35A are shown as individual components, the translatingramps34,35 and the pivoting hingedramps31,33 respectively are illustrated. As shown the translatingramps34,35 have anouter contour38 on both an upper and a lower surface of each translatingramp34,35 and have a dovetail key orprojection37 on eachramp34,35. This key37 allows lateral sides of the pivoting hingedramps31 and33 with a grooved keyway to enter in a dovetail configuration and lock into the translatingramps34,35 while maintaining an ability to slide relative to the other. Theinner bearing surface39 of both the pivoting hingedramps31,33 ride on theouter lift surface38 of the translatingramps34 and35 respectively. In this fashion, during the elevation of theimplant10 from contracted to expanded, the pivoting hingedramps31,33 rest securely on thelift surface38 on both lateral sides of the translatingramp34,35 and thebase plates20,40 hinged to the pivoting hingedramps31,33 at both lateral ends are fully supported across the lateral width of theimplant device10 as the pivoting hingedramps31,33 press against the respective pockets of each base plate. In this construction, there are no gaps between thebase plates20 and40 as the lift surfaces38 of the translatingramps34,35 and bearingsurfaces39 of the pivoting hingedramps31,33 as well as upon expansion the hinged ramps contact the pockets of thebases20,40 as shown best shown inFIG. 8D. All load supporting elements are moved into contact during expansion. Accordingly, thedevice10,10A is extremely rigid between the vertebral bodies and capable of supporting large loads without deflection or deformation when expanded. The hinged lateral side of thebase plates20,40 being fully supported by theframe60 and the expanding lateral side are both fully supported. With reference toFIG. 5C, theframe60, shown slightly below theproximal translation ramp34 and the proximaldrive shaft component51, theframe60 is a singular piece having adistal end62 that has a tapered exterior surface to facilitate insertion.
• Thefixation end plates21,41 accept alocking tab70 used to lock the bone screws100 to thefixation end plates21,41. Thebase plates20,40 are pinned withpins85 to all four pivoting hingedramps31,33 at the hinged points to maintain a bearing surface between the pivoting hingedramps31,33 andbase plates20,40 as well as between the pivoting hingedramps31,33 and translatingramps34,35 at all interbody states. Thebase plates20,40 are also assembled to theframe60 with ahinge pin82 for each top andbottom base plates20,40 as shown. Thebase plates20,40 feature acontoured surface20C,40C to match the surface of the vertebral body endplates. The tangent planes of the base plates'20,40 contoured surfaces can be either parallel or intersecting. A bone screw or threadedfastener100 can be inserted into eachfixation end plates21,41 through the screw holes25,45 located on the integratedfixation end plates21,41 as shown. Thealternative embodiment device10A does not include an integrated fixation plate, as shown inFIG. 1A.
• Each translatingramp34,35 has agroove37 on each side that slides over therails67 on each lateral interior side of theframe60, as shown with a gap between therails67 is provided to allow the assembly to theframe60. These features increase the support and rigidity of the device at all positions of expansion. Thebase plates20,40 also have depressions or pockets into which the pivoting hingedramps31,33 fit and are pinned by thepins85.
• With reference toFIG. 5D, theframe60 is shown with the proximaldrive shaft component51 positioned into the proximal end of theframe60 with theproximal translation ramp34 threaded onto the proximaldrive shaft component51. Shown above theframe60 are a pair ofpins53 that are used to secure the proximaldrive shaft component51 ingrooves53A to theframe60. Also shown above theframe60 is the distaldrive shaft component52 withthreads59. The distaldrive shaft component52 has ahexagonal head56A. The distal translatingramp35 is shown adjacent the distaldrive shaft component52. The distal translatingramp35 is shown with each lateral side having agroove37. Thesegrooves37 fit ontorails67 on the interior walls of theframe60.
• With reference toFIG. 6A, the distaldrive shaft component52 is shown connected to the female 12-point socket56B of the proximaldrive shaft component51 coupling the twodrive shaft components51,52 together to form thedrive shaft50. Thebase plates20,40 are shown with openings to receive hinge pins82, eachhinge pin82 connects abase plate20,40 to theframe60 allowing thebase plates20,40 to pivotally move relative to theframe60 secured by the hinge pins82.
• With reference toFIGS. 7A and 7B, cross sectional views of thedevice10 are shown. InFIG. 7A, thedevice10 is shown in the contracted position with the translatingramps34,35 positioned closer to the midline or center of the device orframe60. In this position, the pivoting hingedramps31,33 are positioned on the lower or contracted positon and therefore are shown hanging down and bearing against the lift surfaces38 of the translatingramps34,35 respectively. With reference toFIG. 7B, as thedrive shaft50 is rotated, the translatingramps34,35 move outwardly toward the proximal and distal ends, respectively. As this occurs, the bearing orsupport surface38 is increasing in height forcing the pivoting hingedramps31,33 to elevate as they ride along thissurface38 tending to push thebase plates20,40 pivotally about the pivot orhinge pin82 and increasing the distance between thebase plates20,40. When this occurs, thedistal end62 is shown exposed with the plates shown extended above that end of thedevice10,10A.
• With reference toFIG. 8A, an end view of the device is illustrated in the fully expanded position. As shown, the translatingramp34,35 is shown positioned over thedrive shaft50 in an extended positon. When this occurs, thebase plates20,40 pivot about the hinge pins82 securely fixed to theframe60. The side opposite the hinge pins82 has an increased expanded height between thebase plates20,40 relative to theframe60. When this occurs, the pivoting hingedramps31,33 are shown almost horizontal abutting the pocket of thebase plates20,40.Hinge31 shown in the upper position,33 in a lower position pinned bypins85 to the base plates. As shown, the pivoting hingedramps31,33 are dovetailed and keyed onto the translatingramps34,35 in this elevated position and during expansion, the translatingramps34,35 slide along the dovetail as the pivoting hingedramps31,33 elevate increasing the expansion height of thedevice10.
• With reference toFIGS. 9A and 9B, thealternative device10A without fixation end plates is illustrated. InFIG. 9A, thedevice10A is shown in the contracted position. InFIG. 9B, thedevice10A is shown in the expanded position. All the elemental components are otherwise the same as in thedevice10 previously discussed. As shown inFIG. 9A, the translatingramps34,35 slide along therail67 of theframe60 by use of agroove37 on each side of the translatingramps34,35. When thedevice10A is in the contracted position, the translatingramps34,35 are moved towards the center of thedevice10A and thethreads58,59 of the drive shaft are basically covered by the translatingramps34,35. When thedevice10A is in the expanded position, as shown inFIG. 9B thethreads58,59 are exposed showing the translatingramps34,35 have moved outwardly, the distal translatingramp35 towards the distal end and the proximal translatingramp34 towards the proximal end of thedevice10A. When this occurs, thedevice10A is in the elevated position. The surgeon can select any position from fully contracted to fully expanded or anywhere in between to choose the desired angle and increase in elevation of thedevice10A as it is expanded.FIG. 9C best illustrates how thebase plates20,40 on the side of thedevice10A opposite the hinged side expand away from theframe60 in the expanded position.
• With reference toFIG. 10A, a side view of thedevice10A is illustrated in the contracted position. With reference toFIG. 10B, thesame device10A is shown in the expanded position.
• With reference toFIG. 11A, thedevice10A in the contracted position is shown in cross section. InFIG. 11B, thedevice10A is shown in cross section in the expanded position.
• FIG. 12A shows a front view of thedevice10A showing thedistal end62 and clearly showing the hinge pins82 on the hinged side of thedevice10A.FIG. 12B is the same frontal view showing thedistal end62 with thebase plates20,40 shown in the expanded position.
• FIG. 13A shows the proximal end of thedevice10A, as shown the proximal end of the device has atorque driving element57 to which a torque driving insertion tool can be inserted to move thedrive shaft50. Thetorque driving element57 provides the ability to rotate thedrive shaft50 to expand or contract the device. When doing so, a torque driving insertion tool is inserted into thetorque driving element57 to engage thedrive shaft50 and provide rotational movement of thedrive shaft50. When thedrive shaft50 is rotated as shown inFIG. 13B, thedevice10A is in the expanded position.
• FIG. 14A is a top view of thedevice10A shown in the contracted position with thethreads58,59 not visible when the translatingramps34,35 are in the contracted position.FIG. 14B is a top view of thedevice10A shown in the expanded position with thethreads58,59 clearly visible as the translatingramps34,35 are moved towards the ends of thedevice10A.
• InFIG. 15A a cross sectional view is shown wherein it is clearly seen where the translatingramps34,35 are positioned relative to thethreads58,59 of thedrive shaft50.FIG. 15B, when in an expanded position shows the translatingramps34,35 are moved towards the ends of thedevice10A.
• Interestingly, as shown, the distal translatingramp34 at the distal end of the device fully supports the distaldrive shaft component52 and the proximaldrive shaft component51 is pinned to theframe60 using pins53. Thepins53 press through thegroove53A in the proximaldrive shaft component51 and are secured inholes63 passing into theframe60.
• A thirdalternative embodiment device10B is illustrated inFIG. 16. Thisthird embodiment10B has the same elements as the first twoembodiments10,10A with the exception that only onebase plate20 is provided. In thisembodiment10B, there is only aframe60. Theframe60 extends between adistal end62 and aproximal end61. Attached to theframe60 is afixation end plate41 similar to thefixation end plate41 attached to thebase plate40. Thisfixation end plate41 is configured similar to thefixation end plate21 of thebase plate20. In thisembodiment10B, the translatingramps34,35 only require the upper surface feature and the pivoting hingedramps31 of the upper part of the device. In such a case, thebase plate20 will move relative to theframe60 as in the previous devices, but there is no underlying base plate to move relative to theframe60 as there is a single base plate. Theframe60 provides the support for a lower adjacent vertebrae and thebase plate20 is used to elevate the upper adjacent vertebrae.
• Thedevice10 generally is shown inserted within aspine20 betweenadjacent vertebrae2,4 as illustrated inFIG. 17. Theinterbody device10 or10A is inserted into the intervertebral body disc space in the collapsed state with the base plates parallel to one another so that the tangent planes of the base plates' contoured surfaces are parallel. Another embodiment of the interbody cage is where in the collapsed state the tangent planes of the base plates' contoured surfaces intersect creating a lordotic angle of various values. The expansion/contraction of the anterior side of the interbody is controlled by rotation of the drive shaft screw. As the drive shaft rotates, the ramp assemblies will articulate the base plates by expanding the anterior side of the base plates away from one another by translating the expanding ramps away from the center of the interbody and pivoting the hinged ramps. This operation distracts the spine vertebrae and adjusts the alignment of the spinal column. The drive shaft has built in stops using a shoulder to restrict movement of the expanding ramps towards the center of the interbody once the interbody has fully collapsed. The device is self-locking at any state allowing complete freedom for anterior height/angle adjustment. The fixation end plates incorporated into the base plates accept screws to fixate the interbody device to the superior and interior spine vertebrae. The locking tabs on the fixation end plates are rotated to introduce a flat surface over the top of the screw holes to prevent the screws from being removed from the fixation end plates and vertebral bodies.
• Variations in the present invention are possible in light of the description of it provided herein. While certain representative embodiments and details have been shown for the purpose of illustrating the subject invention, it will be apparent to those skilled in this art that various changes and modifications can be made therein without departing from the scope of the subject invention. It is, therefore, to be understood that changes can be made in the particular embodiments described, which will be within the full intended scope of the invention as defined by the following appended claims.

Claims (26)

What is claimed is:

1. An expandable interbody fusion implant device comprises:

a frame having a first lateral side and a second lateral side and a distal end and a proximal end;

two ramp assemblies, one being a distal ramp assembly and the other a proximal ramp assembly, each ramp assembly has a translating ramp with a threaded opening, a first pivoting hinged ramp and a second pivoting hinged ramp;

two overlying base plates disposed between the distal end and the proximal end of the frame, each base plate being hinged to a first lateral side of the frame, a first base plate overlying a second base plate, each base plate being hinged to the distal ramp assembly and the proximal ramp assembly at an end of one of said pivoting hinged ramps of each ramp assembly;

a threaded drive shaft pinned to the proximal end of the frame, the drive shaft having a distal drive shaft component having threads for translating the distal ramp assembly and a proximal drive shaft component having threads for translating the proximal ramp assembly, each drive shaft component being coupled to the other, the proximal drive shaft component being affixed to the frame at the proximal end of the frame; and

wherein rotation of the drive shaft drives the distal ramp assembly and proximal ramp assembly simultaneously in opposite directions to selectively expand or contract a distance between the two base plates laterally relative the second lateral side of the frame, simultaneous rotation of both distal and proximal drive shaft components drives the distal and proximal ramps to selectively expand or contract a distance between both first and second base plates to a selected inclination of the first and second base plates relative to the frame over a range of lordotic angles.

2. The expandable interbody fusion implant device ofclaim 1 wherein each translating ramp has an exterior lift surface to guide and support the pivoting hinged ramps during expansion or contraction of the base plates.

3. The expandable interbody fusion implant device ofclaim 1 wherein during expansion of the base plates the distal ramp assembly moves directionally toward the distal end of the frame on rotation of the distal drive shaft component as the proximal ramp assembly simultaneously moves directionally toward the proximal end of the frame on rotation of the proximal drive shaft component, increasing the inclination of the base plates relative to the frame.

4. The expandable interbody fusion implant device ofclaim 2 wherein each pivoting hinged ramp has a bearing support surface configured to slide on the exterior lift surface of the translating ramp.

5. The expandable interbody fusion implant device ofclaim 4 wherein each pivoting hinged ramp bearing support surface is complimentary to the exterior lift surface.

6. The expandable interbody fusion implant device ofclaim 5 wherein the complimentary surface of both the pivoting hinged ramp bearing support surface and the exterior lift surface being inclined with a sloped flat feature.

7. The expandable interbody fusion implant device ofclaim 1 wherein each translating ramp has a pair of opposing sides, each side has a pair of guide channels or grooves configured to receive a projecting rail positioned inside the frame along each first and second lateral side of the frame.

8. The expandable interbody fusion implant device ofclaim 7 wherein each base plate has pockets to which the pivoting hinged ramps are pinned and each translating ramp has a hinge guide channel or hinge guide groove for receiving and guiding one of the pivoting hinged ramps, each pivoting hinged ramp has a lateral side keyed into the hinge guide channel or hinge guide groove.

9. The expandable interbody fusion implant device ofclaim 1 wherein the distal end of the frame has a tapered end configured to facilitate insertion between vertebral bodies.

10. The expandable interbody fusion implant device ofclaim 1 wherein the proximal end of the frame has an opening for receiving an end of the threaded drive shaft and further has the first lateral side with slotted channels to receive a hinge pin fixed to the first or second base plates, the hinge pins configured to allow the base plates to pivot relative to the frame during expansion or contraction.

11. The expandable interbody fusion implant device ofclaim 10 wherein the first and second base plates each have at the proximal end an end plate with a fastener opening for securing the implant to a vertebral body, each end plate being integral to and movable with the base plate during expansion or contraction.

12. The expandable interbody fusion implant device ofclaim 11 wherein each end plate further has a locking tab attached to the end plate, the locking tab being rotatable to cover a portion of the fastener from loosening after being affixed to a vertebral body.

13. The expandable interbody fusion implant device ofclaim 1 wherein the base plates have a laterally inclined outer surface configured to match or mimic a lordotic curvature of the lumbar spine.

14. An expandable interbody fusion implant device comprises:

a frame having a first lateral side and a second lateral side and a distal end and a proximal end;

two ramp assemblies, one being a distal ramp assembly and the other a proximal ramp assembly, each ramp assembly has a translating ramp with a threaded opening, and at least one pivoting hinged ramp;

at least one overlying base plate disposed between the distal end and the proximal end of the frame, the at least one base plate being hinged to a first lateral side of the frame, the at least one base plate being hinged to the distal ramp assembly and the proximal ramp assembly at an end of one of said pivoting hinged ramps of each ramp assembly;

a threaded drive shaft pinned to the proximal end of the frame, the drive shaft having a distal drive shaft component having threads for translating the distal ramp assembly and a proximal drive shaft component having threads for translating the proximal ramp assembly, each drive shaft component being coupled to the other, the proximal drive shaft component being affixed to the frame at the proximal end of the frame; and

wherein rotation of the drive shaft drives the distal ramp assembly and proximal ramp assembly simultaneously in opposite directions to selectively expand or contract a distance between the two base plates laterally relative the second lateral side of the frame, simultaneous rotation of both distal and proximal drive shaft components drives the distal and proximal ramps to selectively expand or contract a distance between both first and second base plates to a selected inclination of the first and second base plates relative to the frame over a range of lordotic angles.

15. The expandable interbody fusion implant device ofclaim 14 wherein each translating ramp has an exterior lift surface contoured to guide and support the pivoting hinged ramps during expansion or contraction of the at least one base plate.

16. The expandable interbody fusion implant device ofclaim 14 wherein during expansion of the at least one base plate, the distal ramp assembly moves directionally toward the distal end of the frame on rotation of the first drive shaft component as the proximal ramp assembly moves directionally toward the proximal end of the frame on rotation of the proximal drive shaft component.

17. The expandable interbody fusion implant device ofclaim 15 wherein each pivoting hinged ramp has a bearing support surface configured to slide on the exterior lift surface of the translating ramp.

18. The expandable interbody fusion implant device ofclaim 17 wherein each pivoting hinged ramp bearing support surface is complimentary to the exterior lift surface.

19. The expandable interbody fusion implant device ofclaim 18 wherein the complimentary surface of both the pivoting hinged ramp bearing support surface and the exterior lift surface being inclined with a sloped flat feature.

20. The expandable interbody fusion implant device ofclaim 14 wherein each translating ramp has a pair of opposing sides, each side has a pair of guide channels or grooves configured to receive a projecting rail positioned inside the frame along each first and second lateral side of the frame.

21. The expandable interbody fusion implant device ofclaim 20 wherein the at least one base plate has pockets to which the pivoting hinged ramps are pinned and each translating ramp has a hinge guide channel or hinge guide groove for receiving and guiding one of the pivoting hinged ramps, each pivoting hinged ramp has a lateral side keyed into the hinge guide channel or hinge guide groove.

22. The expandable interbody fusion implant device ofclaim 14 wherein the distal end of the frame has a tapered end configured to facilitate insertion between vertebral bodies.

23. The expandable interbody fusion implant device ofclaim 14 wherein the proximal end of the frame has a first opening and a second opening for receiving the proximal drive shaft component, and further has lateral sides with slotted channels to receive a pin fixed to the lateral side of each of the at least one base plate, the pin configured to allow the at least one base plate to pivot relative to the first lateral side of the frame during expansion or contraction.

24. The expandable interbody fusion implant device ofclaim 23 wherein the at least one base plate or the frame and one base plate each has at the proximal end an end plate with a fastener opening for securing the implant to a vertebral body, each end plate being integral to and selectively movable with the at least one base plate during expansion or contraction.

25. The expandable interbody fusion implant device ofclaim 24 wherein each end plate further has a locking tab attached to the end plate, the locking tab being rotatable to cover a portion of the fastener from loosening after being affixed to a vertebral body.

26. The expandable interbody fusion implant device ofclaim 25 wherein the implant has a longitudinal length extending between the distal end and the proximal end and a lateral width between opposing first and second lateral sides and the at least one base plate has a convex outer surface having a crowned or peak extending from a midline of the implant and decreasing toward each distal and proximal end, the convex outer surface configured to be complimentary to the endplate of an adjacent vertebral body wherein the convex curvature of the endplate of the vertebral body provides a bearing surface area over a range of angulations of the base plates.

Images