US20200345511A1 - Intervertebral implant device with independent distal-proximal expansion - Google Patents

Abstract

An expandable interbody fusion implant device has a frame, two ramp assemblies and two overlying base plates driven by two independent drive shafts. The two ramp assemblies include a distal ramp assembly and a proximal ramp assembly. Each ramp assembly has a translating ramp, a first pivoting hinged ramp and a second pivoting hinged ramp. The two overlying base plates include a first base plate overlying 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 two independently driven drive shafts include a first drive shaft for translating the distal ramp assembly and a second drive shaft for translating the proximal ramp assembly to independently expand the implant proximally or distally or both.

Description

RELATED APPLICATIONS
• The present application is a continuation of U.S. patent application Ser. No. 15/645,575, filed Jul. 10, 2017, which is a continuation of U.S. patent application Ser. No. 15/363,392, now U.S. Pat. No. 9,750,618, filed Nov. 29, 2016, 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 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, 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. All 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.
• Accordingly, the present invention provides a single device that can be expanded horizontally and parallel or, if preferred, can be expanded distally or proximally or both independently to allow the surgeon to choose the ideal orientation 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 and two overlying base plates driven by two independent drive shafts. The frame has 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, a first pivoting hinged ramp and a second pivoting hinged ramp. The two overlying base plates disposed between the distal end and the proximal end of the frame include a first base plate overlying 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 two independently driven drive shafts include a first drive shaft for translating the distal ramp assembly and a second drive shaft for translating the proximal ramp assembly. Each drive shaft is affixed to the frame at the distal and proximal ends.
• Rotation of the first drive shaft can independently drive the distal ramp assembly to selectively expand or contract a distance between the two base plates distally and rotation of the second drive shaft can independently drive the proximal ramp assembly to selectively expand or contract a distance between the two base plates proximally. Sequential or simultaneous rotation of both first and second drive shafts independently 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 angles.
• Each translating ramp has an exterior lift surface contoured to guide and support the pivoting hinged ramps during expansion or contraction of the base plates. During distal expansion of the base plates the translating ramp of the distal ramp assembly moves directionally toward the distal end of the frame on rotation of the first drive shaft. During proximal expansion of the base plates the translating ramp of the proximal ramp assembly moves directionally toward the proximal end of the frame on rotation of the second drive shaft. Each translating ramp has a stop wall configured to stop the pivoting hinged ramps at a full expansion height on both the distal and proximal ramp assemblies. Each pivoting hinged ramp has a contoured support surface configured to slide on the exterior lift surface of the translating ramp, wherein each pivoting hinged ramp contoured support surface is complimentary to the exterior lift surface. The contoured lift surface has a convex curvature; and the contoured support surface has a concave curvature of similar profile to fit onto a portion of the lift surface. The lift surface curvature of each translating ramp has a radius of curvature of decreasing inclination toward a center of the frame of the device and of increasing inclination toward ends of the frame configured to initially rapidly expand or contract near a collapsed or retracted position and a slower expansion or contraction near a fully expanded position. Each translating ramp has a pair of opposing sides, each side has a pair of guide channels or grooves, one for receiving and guiding one of the pivoting hinged ramps, each pivoting hinged ramp has a lateral side keyed into the guide channel or groove wherein each guide channel or groove extends toward an end forming the stop wall to limit the expansion of the pivoting hinged ramp.
• Preferably, the distal end of the frame has a tapered end configured to facilitate insertion between vertebral bodies. The proximal end of the frame has a first opening and a second opening for receiving the first and second drive shafts, respectively, and further has lateral sides with slotted channels to receive a pin fixed to the proximal end of each of the first and second base plates. The pins configured to allow the base plates to slide relative to the proximal end of the frame during expansion or contraction.
• Preferably, the base plates have an outer surface having a convex curvature with a crown or peak at the longitudinal midline of the implant that decreases as the curvature extends toward the distal or proximal end. The convex curvature is configured to mimic the end plate of the adjacent vertebra it supports and beneficially provides a large bearing surface regardless of the angulation of the base plates.
• In a preferred embodiment, the first and second base plates as an optional feature 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 selectively 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 to prevent loosening after being affixed to a vertebral body. These end plates, when incorporated into the base plates, make the implant device of the present invention a unique standalone device.
• In another alternative embodiment, the implant may only have one base plate, the first or the second base plate and the frame. In that embodiment, an expandable interbody fusion implant device would have a frame having 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 and at least one pivoting hinged ramp, at least one base plate disposed between the distal end and the proximal end of the frame, the at least one base plate overlying 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 at least one pivoting hinged ramp of each ramp assembly, two independently driven drive shafts, a first drive shaft for translating the distal ramp assembly and a second drive shaft for translating the proximal ramp assembly, each drive shaft being affixed to the frame at the distal and proximal ends, and wherein rotation of the first drive shaft can independently drive the distal ramp assembly to selectively expand or contract a distance between the at least one base plate distally, rotation of the second drive shaft can independently drive the proximal ramp assembly to selectively expand or contract a distance between the at least one base plate and the frame proximally and sequential or simultaneous rotation of both first and second drive shafts independently drives the distal and proximal ramps to selectively expand or contract a distance between the at least one base plate and the frame to a selected inclination of the at least one base plate relative to the frame over a range of angles. In this alternative, all the other features are the same as the preferred embodiment.
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. 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 with the distal end expanded and the proximal end contracted.
• FIG. 3B is a side view taken fromFIG. 3A.
• FIG. 3C is the side view taken fromFIG. 3B with threaded fasteners installed in the proximal end of each first and second base plate.
• FIG. 4A is a perspective view of the device ofFIG. 1 shown with the proximal end expanded and the distal end contracted.
• FIG. 4B is a side view taken fromFIG. 4A.
• FIG. 4C is a side view taken fromFIG. 4B with threaded fasteners installed in the proximal end of each first and second base plate.
• FIG. 5A is a perspective view of the device ofFIG. 1 shown with the distal and the proximal end fully expanded.
• FIG. 5B is a side view of the device taken fromFIG. 5A.
• FIG. 5C is a side view taken fromFIG. 5B with threaded fasteners installed in the proximal end of each first and second base plate.
• FIG. 5D is a perspective view of the device ofFIG. 5A with threaded fasteners installed in the proximal end of each first and second base plate.
• FIG. 6A is an exploded side view of the frame and ramp assemblies of the present invention as a first assembly step.
• FIG. 6B is a perspective view of the assembled frame and ramp assemblies ofFIG. 6A with the drive shafts and pins shown exploded as a second assembly step.
• FIG. 6C is a perspective view of the assembled frame, ramp assemblies, drive shafts and pins ofFIG. 6B with the base plates and locking tabs shown exploded as a third assembly step.
• FIG. 6D is a perspective view of the assembled frame, ramp assemblies, drive shafts, pins, base plates and locking tabs ofFIG. 6C with the final pins shown exploded as a fourth assembly step.
• FIG. 7A is a front or proximal view of the device of the present invention shown in a contracted position.
• FIG. 7B is a front or proximal view of the device of the present invention shown in an expanded position.
• FIG. 7C is a front or proximal view of the device of the present invention shown in an expanded position with threaded fasteners installed in the proximal end of each first and second base plate and the locking tabs in an unlocked position.
• FIG. 7D is a front or proximal view of the device of the present invention shown in an expanded position with threaded fasteners installed in the proximal end of each first and second base plate and the locking tabs in a locked position.
• FIG. 8A is a side cross-sectional view of the device of the present invention with the distal drive shaft collapsed.
• FIG. 8B is a side cross-sectional view of the device of the present invention with the proximal drive shaft collapsed.
• FIG. 8C is a side cross-sectional view of the device of the present invention with the distal drive shaft distally expanded.
• FIG. 8D is a side cross-sectional view of the device of the present invention with the proximal drive shaft distally expanded.
• FIG. 8E is a side cross-sectional view of the device of the present invention with the distal drive shaft proximally expanded.
• FIG. 8F is a side cross-sectional view of the device of the present invention with the proximal drive shaft proximally expanded.
• FIG. 8G is a side cross-sectional view of the device of the present invention with the distal drive shaft fully expanded.
• FIG. 8H is a side cross-sectional view of the device of the present invention with the proximal drive shaft fully expanded.
• FIG. 9A is a top cross-sectional view of the device of the present invention in a contracted position.
• FIG. 9B is a top cross-sectional view of the device of the present invention in a distally expanded position.
• FIG. 9C is a top cross-sectional view of the device of the present invention in a proximally expanded position.
• FIG. 9D is a top cross-sectional view of the device of the present invention in a fully expanded position.
• FIG. 10A is a top view of the device of the present invention in a contracted position.
• FIG. 10B is a top view of the device of the present invention in a fully expanded position.
• FIG. 10C is a top view of the device of the present invention in a fully expanded position with threaded fasteners installed in the proximal end of each first and second base plate.
• FIG. 11A is a right cross-sectional view of the device of the present invention in a contracted position at the ramp dovetail feature.
• FIG. 11B is a right cross-sectional view of the device of the present invention in an expanded position at the ramp dovetail feature.
• FIG. 12 is a perspective view of the implant device of the present invention shown implanted between two vertebral bodies of a spine.
• FIG. 13 is a front view taken fromFIG. 12 of the implant device of the present invention shown implanted between two vertebral bodies of a spine.
• FIG. 14 is a perspective view of the implant device of the present invention shown implanted between two vertebral bodies of a spine.
• FIG. 15 is a side view taken fromFIG. 12 of the implant device of the present invention shown implanted between two vertebral bodies of a spine.
• FIG. 16 is a side view of a first alternative embodiment showing the device made with one base plate and a frame.
• FIG. 17A is an end view of a second alternative of the present invention having a laterally inclined outer surface of the base plates configured to mimic a lordotic curvature at a first lordotic angle less than or equal to 10 degrees.
• FIG. 17B is a right section view of the second embodiment ofFIG. 17A.
• FIG. 18A is an end view of a second alternative of the present invention having a laterally inclined outer surface of the base plates configured to mimic a lordotic curvature at a first lordotic angle greater than 10 degrees.
• FIG. 18B is a right section view of the second embodiment ofFIG. 18A.
• FIG. 19A is an end view of a second alternative of the present invention having a laterally inclined outer surface of the base plates configured to mimic a lordotic curvature at a first lordotic angle greater than 15 degrees.
• FIG. 19B is a right section view of the second embodiment ofFIG. 19A.
DETAILED DESCRIPTION OF THE INVENTION
• The intervertebral implant device with independent distal-proximal expansion of the present invention, hereinafter described as an expandable interbodyfusion implant device10, has aframe60, two ramp assemblies,30,32 and twooverlying base plates20,40 driven by twoindependent drive shafts50,52; as illustrated inFIG. 1.
• With reference toFIGS. 1 and 2, thedevice10 shows theframe60 having adistal end62 and aproximal end61. The tworamp assemblies30,32 include a distal translatingramp34 and a proximal translatingramp35 respectively, and further have a first pivoting hingedramp31 and a second pivoting hingedramp33. The twooverlying base plates20,40 are disposed between thedistal end62 and theproximal end61. Thefirst base plate20 overlies thesecond base plate40. Eachbase plate20,40 is hinged to adistal ramp assembly30 and theproximal ramp assembly32 at an end of one of the said pivoting hinged ramps of each ramp assembly. The two independently drivendrive shafts50,52 include afirst drive shaft50 for translating thedistal ramp assembly30 and asecond drive shaft52 for translating theproximal ramp assembly32. Eachdrive shaft50,52 is affixed to theframe60 at the distal and proximal end.
• 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 haveend plates21 and41. These end plates each are provided with a throughhole25 for receiving a threadedfastener100. Threadedfastener100 is shown inFIG. 3C.
• With reference toFIGS. 3A-3C, theimplant device10 is shown where thefirst drive shaft50 has been rotated such that thedistal ramp assembly30 is moved towards the distal end of theframe62. When this occurs the translatingramp34 of thedistal ramp assembly30 moves the pivoting hingedramp31 and33 along an outer surface of the translatingramp34 following the contour of the outer surface. When thisdrive shaft50 is rotationally driven to rotate the distal end thebase plates20,40 both are increased in height from the contracted state to an expanded state. 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 pivoting hinged ramp hits astop wall36 on the translatingramp34. In the fully expanded condition, the distal end is shown elevated relative to the proximal end. This can best be seen inFIG. 3B from a side view. Threadedfasteners100 can be inserted through the throughholes25 in both thefirst end plate21 and thesecond end plate41 of thefirst base plate20 and thesecond base plate40 respectively at any stage/position.
• With reference toFIG. 4A-4C, theimplant device10 alternatively, can have thesecond drive shaft52 rotated in such a fashion that theproximal end61 of theimplant10 will be elevated from a contracted position shown inFIG. 1 to the expanded position as shown inFIGS. 4A-4C. When this occurs, the translatingramp35 of theproximal ramp assembly32 is drawn toward theproximal end61 of theframe60 and as this occurs the pivoting hingedramps31,33 ride on the outer surface of theramp35 such that thefirst base plate20 and thesecond base plate40 are moved increasing in height at theproximal end61 as illustrated. This occurs independent of the distal end of theimplant10 as the distal end has not moved and is in the contracted position as illustrated in this embodiment. This feature allows the surgeon the option to move theimplant10 near thedistal end62 into an expanded condition or, alternatively, near theproximal end61 into an expanded position or can move each end of theimplant10 by whatever increment or amount the surgeon prefers to set a desired angular inclination between the opposingbase plate20,40 surfaces.
• With reference toFIGS. 5A-5C, theimplant device10 is shown where both thefirst drive shaft50 and thesecond drive shaft52 have been rotated into a fully expanded position. When this occurs, thefirst base plate20 moves outwardly both distally and proximally as does thesecond base plate40 move both distally and proximally. Bothbase plates20,40 will move equally as they are driven by the translatingramp34 at thedistal ramp assembly30 and the translatingramp35 of theproximal ramp assembly32 assuming that the contours on bothramps34,35 are made identical in surface contour and elevation. When both driveshafts50,52 are turned in this position, thebase plates20,40 are moved relatively horizontal and parallel to each other which is more conventional to a common expandable implant device. However, a unique feature is that this expansion can be independently adjusted proximally and distally to achieve this position. Onedrive shaft50 or52 can be rotated more or one less to create any desired inclination between a range of maximum full expansion and partially expanded and anywhere in between based on the rotational selection chosen for eachdrive shaft50,52 by the surgeon.
• With reference toFIGS. 6A-6D, various exploded views of the components of theimplant device10 are shown. With reference toFIG. 6A, theramp assemblies30,32 are shown as individual components, the translatingramps34,35 and the pivoting hingedramps31,33 respectively are illustrated. As shown the translatingramps34,35 have anouter contour37 on both an upper and a lower surface of each translatingramp34,35 and have agroove38 on eachramp34,35. Thisgroove38 allows lateral sides of the pivoting hingedramps31 and33 to enter in a dovetail configuration and lock into the translatingramps34,35. Theinner surface39 of both the pivoting hingedramps31,33 ride on theouter surface37 of the translatingramps34 and35 respectively. In this fashion, during the elevation of theimplant10 from contracted to expanded, the pivoting hingedramps31,33 rest securely on thesurface37 on both lateral sides of the translatingramp34,35 such that thebase plates20,40 hinged to the pivoting hingedramps31,33 at both lateral ends are fully supported across the lateral width of theimplant device10. With reference to theframe60, shown slightly below the ramp assembly components, theframe60 is a singular piece having adistal end62 that has a tapered exterior surface to facilitate insertion. With reference to theproximal end61,grooves63 are shown extending vertically, thesegrooves63 are provided such that theend plates21,41 on thefirst base plate20 andsecond base plate40 can be pinned and slidably moved within thegrooves63 or slots on theend plates21,41 such that on expansion of theproximal end61 theend plates21,41 can pivot aboutpins83 inserted through theend plates21,41. This is best illustrated inFIGS. 6C and 6D. Thepins83, as shown inFIG. 6D, engage theend plates21,41and are pressed intoholes23 provided in eachend plate21,41. Theseholes23 and pins83 are shown such that thepins83 extend sufficiently inwardly to be captured within the slot orgroove63 in theproximal end61. As further shown inFIG. 6B, are a pair of drive shaft pins82, these drive shaft pins82 extend through theholes28 in the distal end of theframe60. Theseholes28 extend across theframe60 in such a fashion that thedistal pins82 will engagegrooves53, shown inFIG. 6B, at the distal end of thedrive shafts50,52. At theproximal end61, pins85 are pushed through holes in theend plate64 and will lock intogrooves55 at the proximal end of thedrive shafts50,52. These pins allow the drive shafts to be captured within theframe60 while allowing thedrive shafts50,52 to be freely rotatably when positioned securely and affixed to theframe60 by the use of these pins. With reference toFIG. 6C, theramp assemblies30,32 and driveshafts50,52 are shown affixed to theframe60 with thefirst base plate20 andsecond base plate40 shown above that assembly. A locking means ortab70 is illustrated that is affixed into anopening29 and49 in the two opposingend plates21 and41, respectively. These lockingtabs70, when rotated over the head of thefastener100, prevent thefastener100 from backing out. This effectively completes the assembly of theimplant device10. As further shown inFIG. 6D, the pivoting hingedramps31,33 are pinned to thebase plates20,40 throughholes27 in the base plates and holes22 in the pivoting hinged ramps withpins80,81.
• With reference toFIGS. 7A-7D, end views of theimplant device10 are illustrated. With reference toFIG. 7A, theimplant device10 is shown in the fully contracted position. Theimplant device10, at theproximal end61, shows thefastener openings25 with thelocking tab70 projecting over a portion of thefastener opening hole25. In this condition, thefasteners100 have yet to be inserted into place and could not be until thelocking tab70 is moved into an open positon. With reference toFIG. 7B, theimplant device10 is shown in a fully expanded position as compared toFIG. 7A wherein theimplant10 was shown in the contracted position. With reference toFIG. 7C, when theimplant device10 is in the expanded position and inserted between the vertebral bodies, not shown, thefasteners100 can be inserted through theopenings25 wherein they can be delivered to and fastened to the two vertebral bodies. To accomplish this, thelocking tab70 is rotated with a drive tool, not shown, and the star shapedrecess72 so theopening25 is fully exposed to allow the head of thefastener100 to be inserted into thehole opening25 on insertion. With reference toFIG. 7D, thelocking tab70 is then shown in the locked position, rotated and covering at least partially thehole opening25, thereby preventing thefastener100 from loosening and backing out once inserted and threaded into the vertebral body.
• With reference toFIGS. 8A-8H, various cross-sectional views of theimplant device10 are illustrated. These cross-sectional views are taken down the longitudinal length of thedevice10 in such a way that either theproximal drive shaft50 or thedistal drive shaft52 is shown, the cross section taken through the middle of therespective drive shaft50,52. As shown inFIG. 8A, thedistal drive shaft52 is shown with theimplant device10 in the fully contracted position. In this case, the pivoting hingedramps31,33 are shown at the lowest height on the contoured surfaces37 of the translatingramps34,35 oframp assembly30,32 respectively. As can be seen, the pivoting hingedramps31,33 ride on theexterior surface37 of the translatingramps34,35 and in the contracted position are fully contained and pinned to the respective base plates,20,40. As further shown, thepins82 holding the distal end of thedrive shafts50,52 are shown holding the drive shafts in place at thedistal end62, similarly thepins85 shown extending through theend plate64 of theframe60 are shown holding thedrive shafts50,52 at theproximal end61. There is adrive opening55, shown as a star shaped recess, provided at the proximal end such that the rotation of eachdrive shaft50,52 can be accomplished by the insertion of a drive tool, not illustrated. With reference to thedrive shaft52,threads59 are shown in engagement with complimentaryfemale threads94 on the translatingramp34 to be moved. As shown in the contracted positon, thesethreads94 are fully inside the translatingramp34. With reference toFIG. 8B, theproximal drive shaft50 is illustrated having thethreads58 fully engaged in thethreads95 of theproximal ramp35, again, this is in the fully contracted position, as previously discussed in reference toFIG. 8A. With reference toFIG. 8C, when theimplant10 is expanded at thedistal end62, the translatingramp34 is moved progressively towards thedistal end62 of theframe60 and as it moves toward the end of theframe60, the pivoting hingedramps31,33 slide up the contour on theexterior surface37 of the translatingramp34 elevating thebase plates20,40 respectively. As shown, the translatingramps34,35 are equally contoured, therefore, when thedrive shaft52 is rotated and thethreads59 drive the translatingramp34 toward thedistal end62, thebase plates20,40 move equally expanding away from the fully contracted position. With reference toFIG. 8D, when this occurs, theproximal drive shaft50 has not been moved where thethreads58 are still inside the proximal translatingramp35 engaging thethreads95. With reference toFIGS. 8E and 8F, theimplant10 is shown with theproximal end61 expanded and thedistal end62 contracted. When theproximal end61 of theimplant10 is expanded, the distal translatingramp34 is shown in the contracted position with thethreads59 from thedistal drive52 shaft still fully engaged inthreads94 inside the translatingramp34. Correspondingly, when theproximal drive shaft50 is rotated, it drives the proximal translatingramp35 towards theproximal end61 of theimplant10 as the threads push it toward the proximal end of theimplant10 elevating thebase plates20,40 and as previously discussed, since theramps34,35 are symmetrical in this configuration bothbase plates20,40 move equally apart at theproximal end61. Interestingly, when this occurs, you will notice that theend plates21,41 being integral to thebase plates20,40 will elevate accordingly, as this occurs, they slide and rotate on the same inclination as the base plates. With reference toFIG. 8G and 8H, when both translatingramps34,35 are moved into the fully expanded position, thebase plates20,40 are relatively horizontal and parallel to each other, with the caveat that there is aslight contour20s,40s on the outer surface of eachbase plate20,40 as previously discussed. This contour is quite beneficial as it provides the ability of theimplant device10 to provide a solid mimicking of the endplates of the vertebral bodies that will be supported on implantation. When theseconvex contours20s,40s are positioned within thevertebral body2,4, a slight inclination of thebase plates20,40 still affords a wide surface area of support at theimplant10 as opposed to wedge type devices with straight inclinations on their outer surface. As an alternative embodiment, the outer surface of thebase plates20,40 have an angle mimicking the lordotic curvature of the lumbar spine at multiple angles, as will be discussed with reference toFIGS. 17A-19B. As shown inFIG. 8G, thedistal ramp assembly30 is fully moved toward the expanded position when the distal translatingramp34 is moved toward thedistal end62 of theimplant10. Similarly, theproximal ramp assembly35 is moved toward theproximal end61 of theimplant10. Since they are both moved, the pivoting hingedramps31,33 are elevated by riding on the contouredsurface37 of the translatingramps34,35 increasing the height of theimplant device10 to the fully expanded position as shown inFIG. 8H.
• With reference toFIG. 9A-9D, top cross sectional views are shown to facilitate an understanding of theramp assemblies30,32. With reference toFIG. 9A, the translatingramps34,35 are shown in the contracted position, thus are spaced away from the distal62 and proximal61 ends, as illustrated. In such a configuration, thethreads58,59 on eachdrive shaft50,52 are fully encased within their respective translatingramps34,35. With reference toFIG. 9B, when thedistal end62 is elevated from the contracted position as shown inFIG. 9A, thedrive shaft52 is shown with thethreads59 partially exposed wherein the translatingramp34 at thedistal end62 is moved distally, almost into contact with theframe60 at thedistal end62. With reference toFIG. 9C, shows the alternate configuration where the translatingramp35 is moved toward theproximal end61 of theimplant10 and the distal translatingramp34 is shown in the contracted position. With reference toFIG. 9D, in the fully expanded configuration, both translatingramps34,35 are shown moved toward the distal62 and proximal61 ends and not spaced therefrom.
• With reference toFIGS. 10A-10C, an outline drawing of theimplant device10 from a top view is shown. InFIG. 10A, thedevice10 is in a fully contracted position, whereas the top view ofFIG. 10B shows the device in a fully expanded position. With reference toFIG. 10C, theimplant device10 is shown with threadedfasteners100 inserted in thehole openings25. It is hoped that these additional views showing how thedevice10 is actually positioned during the various stages of inclination and various conditions from contracted to fully expanded and the ability of thedevice10 to be distally expanded independent of proximal expansion and proximally expanded independent of distal expansion has been shown throughout the various views previously discussed.
• With reference toFIGS. 11A and 11B, cross sectional views of theramp assemblies30,32 are shown contained in theframe60 andbase plates20,40. InFIG. 11A, theimplant device10 is shown in a fully contracted position, when this occurs, theimplant device10 shows the pivoting hingedramps31,33 with thegroove38 shown as a dovetail feature that interlocks the lateral sides of the pivoting hingedramps31,33 projecting inwardly the dovetail or groove38 of the translatingramp34,35 as illustrated. When this occurs, it locks the ramp from moving laterally. As shown, this prevents the pivoting hingedramps31,33 from laterally shifting when thedevice10 is in the expanded position, furthermore, thebase plates20,40 further provide a constraint on movement of the translatingramps34,35 to which the pivoting hingedramps31,33 are attached. With reference toFIG. 11B, the pivoting hingedramp31,33 is shown in the elevated or expanded position, an important aspect of the present invention as illustrated is that even in the fully expanded position, it is noticed that the pivoting hingedramps31,33 are fully supported on both sides by the translatingramps34,35. This provides lateral stability for thebase plates20,40 that are hinged to the pivoting hingedramps31,33 on each lateral side. This means that the rigidity of thedevice10 is extremely secure and thedevice10 is unlikely to flex or twist.
• With reference toFIGS. 12-15, theimplant device10 is shown inserted between two adjacentvertebral bodies2,4 on implantation. As illustrated inFIGS. 12 and 13, it is clearly shown how thedevice10 will be implanted.FIG. 14, similarly shows a different perspective view of the implanteddevice10.FIG. 15, on a head-on view, shows that most of thedevice10 is hidden by the disc space when inserted in between thevertebral bodies2,4.
• An important aspect of the present invention although not fully discussed is best seen in the top views. With reference toFIGS. 10A-10B, top views of theimplant device10 are illustrated, it is important to understand that the top and bottom views are virtually identical and that thebase plates20,40 provide a perimeter frame with a large opening or aperture12. When thedevice10 is in the expanded position either proximally or distally one of the translatingramps34,34 will move making the aperture or opening space12 between thebase plates20,40 extremely large. When both translatingramps34,35 are moved into the expanded position this aperture space is increased even further. This provides for a large amount of space for allograft material or other biologics to be placed inside theimplant device10 to enhance the osteoinductive effect of new bone growth which is extremely important in any fusion device. It is believed that this capability is best achieved by the drive mechanisms used that are independently driven by the mechanism of this implant device according to the present invention.
• While the present invention has been shown withendplates21,41, these end plates could be removed and theimplant device10 would no longer be a standalone device which can be inserted and then fastened directly into the vertebral bodies, but may have a separate vertebral plate that can be added if these end plates are not provided. These optional features, when provided, show the best mode of practicing the invention. However, they are not necessary for utilization of thedevice10 according to the present invention.
• Thepreferred device10 is shown where the base plates are provided on both an upper and a lower surface. Also, as a first alternative embodiment,device10A, it is understood that one base plate could be provided only and that the frame itself would be a stationary base plate. In such a condition either thebase plate20 orbase plate40 could be removed and only one provided, as shown inFIG. 16. Furthermore, it is understood that the angular inclination of thedevice10,10A is only limited by the maximum height that the device can be expanded. The device is only limited by the shape and contours of the ramps. As noted, the ramps have a radius contour or curved contour such that it increases rapidly at initial movement from a contracted position and this rate of movement changes as the ramp achieves the peak of the curvature. This provides for very fine tuning and adjustment by the surgeon as he approaches a maximum condition and a larger range of height adjustment with a constant bearing surface area for increased stability at all expanded heights. It is further understood that any inclination between contracted and fully expanded can be established by simply stopping the rotation of the drive shaft. The drive shaft will maintain its position regardless of where it is stopped. Therefore, the surgeon can pick precisely the location he wants to elevate the proximal or distal end independent of the other such that any inclination can be achieved with the range of that provided by the threads on the ramp and drive shaft and the contour surface of the ramps themselves. These and other variations can be achieved by the present device which is believed unique over all expandable implant devices currently in use.
• The present invention can be made in a variety of sizes, by way of example, widths: 18 mm and 22 mm; longitudinal lengths: 40, 45, 50, 55, and 60 mm; Distal and Proximal end height: 8 mm; Center height range: 9 mm (contracted)-15 mm (expanded); Maximum distal or proximal angle: 40 mm length: 10°; 45 mm length: 9°; 50 mm length: 8°; 55 mm length: 7°; 60 mm length: 6°.
• With reference toFIGS. 17A-19B, a secondalternative embodiment10B is shown having a laterally inclined outer surface of thebase plates20,40 configured to mimic a lordotic curvature of the lumbar spine.FIGS. 17A-17B illustrate a 7° Lordosis-Anterior (tall side) height range: 10 mm-16 mm.FIGS. 18A-18B illustrate a 14° Lordosis-Anterior (tall side) height range: 12 mm-18 mm.FIGS. 19A-19B illustrate a 21° Lordosis-Anterior (tall side) height range: 14 mm-20 mm. The effective angles are achieved by changing the thickness of the left or anterior side of the base plates relative to the right side of the base plates.
• 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 (14)

What is claimed is:

1. An expandable interbody fusion implant device comprises:

a frame having 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, 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, 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;

two independently driven drive shafts, a first drive shaft for translating the distal ramp assembly and a second drive shaft for translating the proximal ramp assembly, each drive shaft being affixed to the frame at the distal and proximal ends; and

wherein rotation of the first drive shaft can independently drive the distal ramp assembly to selectively expand or contract a distance between the two base plates distally, rotation of the second drive shaft can independently drive the proximal ramp assembly to selectively expand or contract a distance between the two base plates proximally and sequential or simultaneous rotation of both first and second drive shafts independently 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 angles.

2. The expandable interbody fusion implant device ofclaim 1 wherein each translating ramp has an exterior lift surface contoured 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 distal expansion of the base plates the distal ramp assembly moves directionally toward the distal end of the frame on rotation of the first drive shaft.

4. The expandable interbody fusion implant device ofclaim 1 wherein during proximal expansion of the base plates the proximal ramp assembly moves directionally toward the proximal end of the frame on rotation of the second drive shaft.

5. The expandable interbody fusion implant device ofclaim 1 wherein each translating ramp has a stop wall configured to stop the pivoting hinged ramps at a full expansion height on both the distal and proximal ramp assemblies.

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

7. The expandable interbody fusion implant device ofclaim 6 wherein each pivoting hinged ramp contoured support surface is complimentary to the exterior lift surface, the complimentary surface of each being inclined with a sloped flat feature or a contoured curved feature.

8. The expandable interbody fusion implant device ofclaim 7 wherein the contoured lift surface has a convex curvature; and the contoured support surface has a concave curvature of similar profile to fit onto a portion of the lift surface.

9. The expandable interbody fusion implant device ofclaim 8 wherein the lift surface curvature of each translating ramp has a radius of curvature of decreasing inclination toward a center of the frame of the device and of increasing inclination toward ends of the frame configured to initially rapidly expand or contract near a collapsed or retracted position and a slower expansion or contraction near a fully expanded position configured to allow a larger range of height adjustment with a constant bearing surface area for increased stability of all expanded heights.

10. 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, one for receiving and guiding one of the pivoting hinged ramps, each pivoting hinged ramp has a lateral side keyed into the guide channel or groove wherein each guide channel or groove has an end to limit the expansion of the pivoting hinged ramp.

11. 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.

12. The expandable interbody fusion implant device ofclaim 1 wherein the proximal end of the frame has a first opening and a second opening for receiving the first and second drive shafts, respectively, and further has lateral sides with slotted channels to receive a pin fixed to the proximal end of each of the first and second base plates, the pins configured to allow the base plates to slide relative to the proximal end of the frame during expansion or contraction.

13. The expandable interbody fusion implant device ofclaim 12 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 selectively movable with the base plate during expansion or contraction.

14. The expandable interbody fusion implant device ofclaim 13 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.

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