Patent Application
20180353302
The present invention, in general, relates to an intervertebral implant, and more specifically, relates to an adjustable, implantable spinal disc device which can be used for deformity correction in intervertebral fusion procedures.
Joint degeneration and injury is a common medical condition that can occur in a variety of joints throughout the human body, especially with increasing age, and initially is often treated conservatively, such as through medication and/or physical therapy. Genetic or developmental irregularities, trauma, chronic stress, tumors, and degenerative wear are a few of the causes that can result in spinal pathologies for which surgical intervention may be necessary.
In the spine, depending upon the degree of degeneration, injury, mobility, and pain, for example, intervertebral fusion may be the surgical treatment of choice. A wide variety of systems and devices, often referred to as intervertebral “cages”, have been disclosed in the art which achieve immobilization and/or fusion of adjacent bones by implanting artificial assemblies in or on the spinal column, such as for treatment of intervertebral disc degeneration, for example. The spinal intervertebral disc is situated between adjacent vertebral bodies, and comprises an annulus fibrosus and a nucleus pulposis. With respect to the failure of the intervertebral disc, for intervertebral fusion procedures, the intervertebral disc may be removed, and as a replacement, an artificial intervertebral disc device (such as an interbody fusion cage) may be inserted and secured between the adjacent vertebral bodies. Once inserted and secured, the intervertebral disc device separates and holds the adjacent vertebral bodies apart, typically relieving the pressure on affected nerves, reducing mechanical instability, and potentially also reducing corresponding pain.
With aging, however, the natural curvatures of the spine may also deteriorate, such as a straightening of the lumbar spine and loss of the natural lordosis. In addition to such anterior-posterior deformities or deteriorations, there may be additional left-right (or sagittal) deformities which have occurred over time as well. Various prior art methods of correcting such curvature deformities, however, tend to have a significantly high failure rate, with a failure to fuse on the order of 30% to 60%, for example.
As a result, a need remains for an adjustable, implantable spinal disc device which can correct such spinal deformities and degenerative changes in an intervertebral fusion procedure. In addition, such an adjustable, implantable spinal disc device should promote bony fusion with and between the adjacent vertebral bodies to achieve greater mechanical stability while simultaneously restoring appropriate spinal curvatures, such as lordosis and kyphosis.
The representative embodiments of the present invention provide numerous advantages. Representative embodiments of an adjustable, implantable spinal disc device, as a spinal implant, assembly or cage, are disclosed having transverse plate members which each include a respective arcuate extension. The arcuate extensions have mating contours which are slidable with respect to each other (prior to fixation), generally allowing angular movement or rotation of the transverse plate members with respect to each other, in both the sagittal and coronal planes. This therefore allows the transverse plate members of the adjustable, implantable spinal disc device to be angularly offset with respect to each other, to create or restore the desired configuration of the spine in situ, such as a lordotic curvature or kyphotic curvature. The representative embodiments of an adjustable, implantable spinal disc device also allow mounting of additional extension or spacing endplates, in order to adjust the height (longitudinal) of the representative embodiments of an adjustable, implantable spinal disc device.
The representative embodiments of an adjustable, implantable spinal disc device further include a comparatively large and continuous central through-channel or cavity defined by the arcuate extensions, for bone graft placement and subsequent fusion of the bone graft to both of the adjacent vertebral bodies, not just one. This bone graft in the continuous central through-channel or cavity, connecting to both adjacent vertebrae, provides significantly improved mechanical stability of the fused vertebrae, and significantly reduces the graft failure rate in deformity correction. The location of the continuous central through-channel or cavity within the arcuate extensions is also especially significant, as the arcuate extensions effectively protect the bone graft material of the central through-channel or cavity from dissipation or other erosion during the healing, bone graft solidification and bone growth of the fusion process, such as protecting the bone graft material from any of the various body fluids which would otherwise contact and erode the bone graft material before the fusion process has been completed.
A representative embodiment of a spinal disc device is disclosed which is implantable between adjacent vertebral bodies, comprising: a first transverse plate member; a first arcuate extension coupled to and extending longitudinally from the first transverse plate member, the first arcuate extension having a first configuration; a second transverse plate member; and a second arcuate extension coupled to and extending longitudinally from the second transverse plate member, the second arcuate extension having a second, mating configuration with the first configuration of the first arcuate extension and slideably moveable with respect to the first arcuate extension, the first arcuate extension and the second arcuate extension further arranged to form a central through-channel between the first and second transverse plate members.
In a representative embodiment, the first transverse plate member further comprises a first through-hole and the second transverse plate member further comprises a second through-hole, the first and second through-holes arranged to communicate with the central through-channel. In a representative embodiment, the central through-channel is arranged to hold bone graft material.
In a representative embodiment, the first configuration of the first arcuate extension and the second configuration of the second arcuate extension may each be a partially spherical, convex shell configuration. For such a representative embodiment, the first arcuate extension is slideably moveable in both a sagittal plane and a coronal plane with respect to the second arcuate extension. Also in such a representative embodiment, following implantation between the adjacent vertebral bodies, the first arcuate extension may be slideably moveable in both a sagittal plane and a coronal plane with respect to the second arcuate extension for deformity correction prior to fixation.
In another representative embodiment, an inner surface of the first arcuate extension may have a partially spherical, concave configuration and an outer surface of the second arcuate extension may have a partially spherical, convex configuration; or alternatively, an inner surface of the second arcuate extension may have a partially spherical, concave configuration and an outer surface of the first arcuate extension may have a partially spherical, convex configuration.
In a representative embodiment, the first arcuate extension and the second arcuate extension may be further arranged to overlap each other in the longitudinal dimension.
In a representative embodiment, the spinal disc device also may further comprise: at least one extension endplate coupleable longitudinally to the first transverse plate member or to the second transverse plate member. For such a representative embodiment, the at least one extension endplate may further comprise a third through-hole arranged to communicate with the central through-channel.
In a representative embodiment, one or more of the first transverse plate member, the second transverse plate member, the first arcuate extension, and the second arcuate extension may comprise a material selected from the group consisting of: pyrolytic carbon, titanium, porous titanium, titanium nitride, tantalum, cobalt, chromium, polyethylene, carbon fiber, PEEK® (Polyether ether ketone), acetal homopolymer resin, alumina, zirconia, silicon carbide, silicon nitride, stainless steel, diamond, or a diamond-like material
Also in a representative embodiment, the central through-channel has a first volume and the spinal disc device has a second volume, wherein the first volume may be at least 50% of the second volume.
Representative embodiments of a kit for a spinal disc device implantable between adjacent vertebral bodies is also disclosed, with the kit comprising: a plurality of first components, each first component of the plurality of first components comprising: a first transverse plate member; and a first arcuate extension coupled to and extending longitudinally from the first transverse plate member, the first arcuate extension having a first configuration; and a plurality of second components, a second component of the plurality of second components coupleable to a first component of the plurality of first components to form a spinal disc device, each second component of the plurality of second components comprising: a second transverse plate member; and a second arcuate extension coupled to and extending longitudinally from the second transverse plate member, the second arcuate extension having a second, mating configuration with the first configuration of the first arcuate extension and slideably moveable with respect to the first arcuate extension for each of the first components, the first arcuate extension and the second arcuate extension further arranged to form a central through-channel between the first and second transverse plate members for each of the first and second components.
For a representative embodiment of such a kit, each first transverse plate member further comprises a first through-hole and each second transverse plate member further comprises a second through-hole, the first and second through-holes arranged to communicate with the central through-channel when the first component is coupled to the second component.
For a representative embodiment of such a kit, each first transverse plate member of the plurality of first components may have a different lateral dimension, or a different lateral configuration, or a different longitudinal thickness. In addition, for a representative embodiment of such a kit, each second transverse plate member of the plurality of second components has a different lateral dimension, or a different lateral configuration, or a different longitudinal thickness.
For a representative embodiment of such a kit, for each of the first and second components, the first configuration of the first arcuate extension and the second configuration of the second arcuate extension may each be a partially spherical, convex shell configuration.
Such a representative embodiment of a kit for a spinal disc device also may further comprise: a plurality of extension endplates, each extension endplate coupleable longitudinally to the first transverse plate members of the plurality of first components or to the second transverse plate members of the plurality of second components. For such a representative embodiment, each extension endplate may further comprise a third through-hole arranged to communicate with the central through-channel when coupled to the first transverse plate member or to the second transverse plate member and when the first component is coupled to the second component. Such a representative embodiment of a kit for a spinal disc device also may further comprise: a plurality of screws to couple the first transverse plate member and the second transverse plate member to adjacent vertebral bodies.
A representative embodiment of a spinal disc device is disclosed which is implantable between adjacent vertebral bodies, comprising: a first transverse plate member, the first transverse plate member further comprising a first through-hole; a first arcuate extension coupled to and extending longitudinally from the first transverse plate member, the first arcuate extension having a partially spherical, convex shell configuration; a second transverse plate member, the second transverse plate member further comprising a second through-hole; and a second arcuate extension coupled to and extending longitudinally from the second transverse plate member, the second arcuate extension having a second, mating partially spherical, convex shell configuration and slideably moveable with respect to the first arcuate extension, the first arcuate extension and the second arcuate extension further arranged to form a central through-channel between the first and second transverse plate members and in communication with the first and second through-holes.
For such a representative embodiment, the first arcuate extension and the second arcuate extension are further arranged to overlap each other in the longitudinal dimension, and wherein the central through-channel is arranged to hold bone graft material.
Numerous other advantages and features of the present invention will become readily apparent from the following detailed description of the invention and the embodiments thereof, from the claims and from the accompanying drawings.
The objects, features and advantages of the present invention will be more readily appreciated upon reference to the following disclosure when considered in conjunction with the accompanying drawings, wherein like reference numerals are used to identify identical components in the various views, and wherein reference numerals with alphabetic characters are utilized to identify additional types, instantiations or variations of a selected component embodiment in the various views, in which:
Figure (or “FIG.”) 1 is an isometric view of a first representative embodiment of an adjustable, implantable spinal disc device.
Figure (or “FIG.”) 2 is a front elevational view of a first representative embodiment of an adjustable, implantable spinal disc device.
Figure (or “FIG.”) 3 is a side elevational view of a first representative embodiment of an adjustable, implantable spinal disc device.
Figure (or “FIG.”) 4 is a top, plan view of a first representative embodiment of an adjustable, implantable spinal disc device.
Figure (or “FIG.”) 5 is a bottom view of a first representative embodiment of an adjustable, implantable spinal disc device.
Figure (or “FIG.”) 6 is a first cross-sectional view of the first representative embodiment of an adjustable, implantable spinal disc device illustrated in
Figure (or “FIG.”) 7 is a second cross-sectional view of the first representative embodiment of an adjustable, implantable spinal disc device illustrated in
Figure (or “FIG.”) 8 is a third cross-sectional view of the first representative embodiment of an adjustable, implantable spinal disc device illustrated in
Figure (or “FIG.”) 9 is an isometric view of a representative embodiment of an additional, spacing endplate for use with an adjustable, implantable spinal disc device.
Figure (or “FIG.”) 10 is a front elevational view of a representative embodiment an adjustable, implantable spinal disc device with additional, spacing endplates.
Figure (or “FIG.”) 11 is a side elevational view of a representative embodiment of an adjustable, implantable spinal disc device illustrated between adjacent vertebral bodies and further having an anterior-posterior (coronal plane) angular adjustment.
Figure (or “FIG.”) 12 is a front elevational view of a representative embodiment of an adjustable, implantable spinal disc device, with additional spacing endplates, illustrated between adjacent vertebral bodies and further having a left-right (sagittal plane) angular adjustment.
Figure (or “FIG.”) 13 is an isometric view of a second representative embodiment of an adjustable, implantable spinal disc device.
Figure (or “FIG.”) 14 is a cross-sectional view of a second representative embodiment of an adjustable, implantable spinal disc device illustrated in
Figure (or “FIG.”) 15 is an isometric view of a third representative embodiment of an adjustable, implantable spinal disc device.
Figure (or “FIG.”) 16 is a top, plan view of a transverse location on a vertebral body and a corresponding potential configuration or shape of a first transverse plate member (or endplate) and/or second transverse plate member (or endplate) of a representative embodiment of an adjustable, implantable spinal disc device.
Figure (or “FIG.”) 17 is an isometric view of a representative embodiment of kit for a representative embodiment of an adjustable, implantable spinal disc device.
While the present invention is susceptible of embodiment in many different forms, there are shown in the drawings and will be described herein in detail specific exemplary embodiments thereof, with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the invention to the specific embodiments illustrated. In this respect, before explaining at least one embodiment consistent with the present invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of components set forth above and below, illustrated in the drawings, or as described in the examples. Methods and apparatuses consistent with the present invention are capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein, as well as the abstract included below, are for the purposes of description and should not be regarded as limiting.
Representative embodiments of an adjustable, implantable spinal disc device (100, 100A, 100B), as a spinal implant, assembly or cage, are disclosed having transverse plate members (or endplates) 105, 110 which each include a respective arcuate extension 115, 120 collectively forming a coupling member 185. The arcuate extensions 115, 120 have mating contours which are slidable with respect to each other (prior to fixation), generally allowing angular movement or rotation of the transverse plate members (or endplates) 105, 110 with respect to each other, in both the sagittal and coronal planes, allowing the transverse plate members (or endplates) 105, 110 of the adjustable, implantable spinal disc device (100, 100A, 100B) to be angularly offset with respect to each other, to create or restore the desired configuration of the spine in situ, such as a lordotic curvature or kyphotic curvature. The representative embodiments of an adjustable, implantable spinal disc device (100, 100A, 100B) further include a comparatively large and continuous central through-channel or cavity 150 defined by the arcuate extensions 115, 120, for bone graft placement and subsequent fusion of the bone graft to both of the adjacent vertebral bodies 170, 175. The representative embodiments of an adjustable, implantable spinal disc device (100, 100A, 100B) also allow mounting of additional extension or spacing endplates 155, in order to adjust the height (longitudinal) of the representative embodiments of an adjustable, implantable spinal disc device (100, 100A, 100B). The transverse plate members (or endplates) 105, 110 and any additional spacing endplates 155 also may be secured to the corresponding, adjacent vertebral bodies with one or more screws, for example.
Following removal of an intervertebral disc from between adjacent vertebral bodies, a representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B) is inserted and secured between the adjacent vertebral bodies 170, 175, typically in an anterior surgical procedure. The representative embodiments of an adjustable, implantable spinal disc device (100, 100A, 100B) then allow changes in spine configuration in coronal and sagittal planes during the subsequent posterior stages of the surgical procedure, for deformity correction, such as to restore a lordotic curvature or a kyphotic curvature, and typically secured using rods and screws inserted into corresponding pedicles of the adjacent vertebrae. The representative embodiments of an adjustable, implantable spinal disc device (100, 100A, 100B) also allow for better adaptability of the adjustable, implantable spinal disc device (100, 100A, 100B) to the angles or the adjacent vertebral bodies during the anterior stages or the surgical procedure for other spine reconstruction and bone grafting. The representative embodiments of an adjustable, implantable spinal disc device (100, 100A, 100B) are suitable for cervical and lumbar applications, for example.
While the various representative embodiments of an adjustable, implantable spinal disc device (100, 100A, 100B), for purposes of illustration and explanation, are shown and described as having different shapes and features, any of the various shapes, configurations, elements, materials and features may be utilized in any selection, in any permutation and/or combination, and in any embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B), and any and all of which are within the scope of the claimed invention. In addition, for purposes of illustration and explanation, the directions and orientation of the representative embodiments of an adjustable, implantable spinal disc device (100, 100A, 100B) are discussed with reference to the coronal (anterior-posterior), sagittal (left-right) and transverse (upper-lower, or superior-inferior, or cranial-caudal) planes of a human body, with a longitudinal direction or orientation substantially perpendicular (orthogonal) to the transverse plane.
Referring to
Those having skill in the art will recognize that the first and second transverse plate members (or endplates) 105, 110 may have a plurality of configurations, shapes, sizes, and contours, any and all of which are considered equivalent and within the scope of the disclosure. In any selected embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B), the first and second transverse plate members (or endplates) 105, 110 may have the same or similar configuration, shape, size, and contour, or the first and second transverse plate members (or endplates) 105, 110 may each have different configurations, shapes, sizes, and contours, such as for appropriate matching to different, adjacent first and second vertebral bodies 170, 175. A variety of additional configurations, shapes, sizes, and contours of the first and second transverse plate members (or endplates) 105, 110 are illustrated and discussed below with reference to
For example and without limitation, while the contact surfaces 205 and 220 may be substantially flat, such may alternatively include one or more bone adhesion facilitating elements, which are operable to promote bone adhesion to the vertebral bodies 170, 175. For example and without limitation, the bone adhesion facilitating elements may include one or more of spikes, keels, roughening elements, etc. In addition, numerous other modifications may be employed on the first and second transverse plate members (or endplates) 105, 110, such as screws, flanges, coatings, dimples, beads, shock absorption members, etc., also for example and without limitation. Additionally, the surfaces 205 and 220 of the first and second transverse plate members (or endplates) 105, 110 may further comprise at least a lateral ring of porous coating (which may be a sprayed deposition layer, an adhesive applied beaded metal layer, or other suitable porous coatings known in the art). This porous coating permits the long term ingrowth of vertebral bone into first and second transverse plate members (or endplates) 105, 110 as part of permanently securing the representative embodiments of an adjustable, implantable spinal disc device (100, 100A, 100B) between the adjacent vertebral bodies 170, 175. In a representative embodiment, the porous coating may comprise zirconium oxide ceramic, also for example and without limitation.
Also for example and without limitation, in any one of the representative embodiments of an adjustable, implantable spinal disc device (100, 100A, 100B), the first transverse plate member (or endplate) 105 and/or second transverse plate member (or endplate) 110 may be circular, elliptical, trapezoidal, rhomboidal, square, rectangular, an irregular or regular polygon or Reuleaux polygon, or any other shape or configuration in the transverse or lateral dimension or orientation. The lateral configuration or shape and size of the first and second transverse plate members (or endplates) 105, 110 are generally selected to at least partially overlap at least some of the epiphysial rim or ring (180) of the first and/or second vertebral body 170, 175, and will also generally vary with the type and size of the vertebral body 170, 175, such as a cervical or lumbar vertebral body 170, 175. Also for example and without limitation, the first and/or second transverse plate members (or endplates) 105, 110 may each be polygonal in shape or configuration in the transverse or lateral dimension or orientation, wherein the polygon comprises at least four side edges. Additionally, such a polygon may have either straight or curved sides (alternately called a Reuleaux polygon), and may also have sides with different lengths and smoothly blended intersections. For example and without limitation, as illustrated in
When the first representative embodiment of an adjustable, implantable spinal disc device 100 is inserted in between adjacent first and second vertebral bodies 170, 175, the first surface 205 of the first transverse plate member (or endplate) 105 will be contacting or abutting the first vertebral body 170, and more particularly the epiphysial rim or ring (180) of the first vertebral body 170, and the second surface 220 of the second transverse plate member (or endplate) 110 will be contacting or abutting the second vertebral body 175, and more particularly the epiphysial rim or ring (180) of the second vertebral body 175. The first transverse plate member (or endplate) 105 and the second transverse plate member (or endplate) 110 are typically secured anteriorly to the respective adjacent first and second vertebral bodies 170, 175 using one or more screws 145 inserted into one or more (anterior) screw holes 130, 135, as shown in
In other embodiments discussed below, one or more extension or spacing endplates 155 may be inserted and coupled between the first transverse plate member (or endplate) 105 and the first vertebral body 170 and/or inserted and coupled between the second transverse plate member (or endplate) 110 and the second vertebral body 175.
The coupling member 185 comprises a first arcuate (or curvate) extension 115 and a second arcuate (or curvate) extension 120. The first arcuate extension 115 is coupled to and extends generally longitudinally (and in some embodiments, substantially perpendicularly) from the second surface 210 of the first transverse plate member (or endplate) 105, and the second arcuate extension 120 is coupled to and extends generally longitudinally (and in some embodiments, substantially perpendicularly) from the first surface 215 of the second transverse plate member (or endplate) 110. The first arcuate extension 115 and the second arcuate extension 120 surround and define a central through-channel or cavity 150, such that the representative embodiments of an adjustable, implantable spinal disc device 100 (and 100A, 100B) are substantially hollow. The lateral and longitudinal configurations of the central through-channel or cavity 150 will generally match the lateral and longitudinal configurations of the first arcuate (or curvate) extension 115 and the second arcuate (or curvate) extension 120.
The coupling member 185 can be of any design that permits articulating motion of the first arcuate (or curvate) extension 115 and a second arcuate (or curvate) extension 120 (and their respectively coupled first and second transverse plate members (or endplates) 105, 110) relative to one another, provided that the design allows for a central through-channel or cavity 150 traversing the thickness of the coupling member 185 while still maintaining sufficient strength to maintain its structural integrity under anatomical loads and stress. For example, the desired strength of the coupling member 185 can be achieved by varying the material selection and thicknesses of the first arcuate (or curvate) extension 115 and a second arcuate (or curvate) extension 120.
Also for example and without limitation, the first and second transverse plate members (or endplates) 105, 110 may be comprised of titanium or porous titanium and have a longitudinal thickness between about 1-10 mm, such as 2-3 mm, with a lateral extent and configuration selected to be an appropriate size to correspond to a selected vertebral body 170, 175. Also for example and without limitation, the first and second transverse plate members (or endplates) 105, 110 may be comprised of titanium or porous titanium and have a plate thickness between about 1-10 mm. Other materials which may be utilized for any of the first and second transverse plate members (or endplates) 105, 110 and the first and second arcuate (or curvate) extensions 115, 120 are discussed in greater detail below.
In addition, each of the first transverse plate member (or endplate) 105 and the second transverse plate member (or endplate) 110 have respective first and second through-holes or channels 125, 140, providing significant external access to the comparatively large and continuous central through-channel or cavity 150 defined by the first and second arcuate extensions 115, 120. These through-holes or channels 125, 140 provide for the insertion of packing of bone graft material into the central through-channel or cavity 150, to fill the central through-channel or cavity 150 and both the first and second through-holes or channels 125, 140 with the bone graft material, prior to the placement of the representative embodiment of an adjustable, implantable spinal disc device 100 (and 100A, 100B) between the adjacent first and second vertebral bodies 170, 175 in a surgical procedure. The central through-channel or cavity 150 and the first and second through-holes or channels 125, 140 thereby provide for a comparatively and substantially large and continuous bone graft between the adjacent first and second vertebral bodies 170, 175, further serving to mechanically stabilize and fuse the adjacent first and second vertebral bodies 170, 175.
Also for example and without limitation, in any one of the representative embodiments of an adjustable, implantable spinal disc device (100, 100A, 100B), the first and second through-holes or channels 125, 140 may be circular, elliptical, trapezoidal, rhomboidal, square, rectangular, an irregular or regular polygon or Reuleaux polygon, or any other shape or configuration in the transverse or lateral dimension or orientation, such as polygonal in shape or configuration in the transverse or lateral dimension or orientation, wherein the polygon comprises at least four side edges. Additionally, such a polygon may have either straight or curved sides (alternately called a Reuleaux polygon), and may also have sides with different lengths and smoothly blended intersections. For example and without limitation, as illustrated in
A significant departure from the prior art, the first and second arcuate extensions 115, 120 define and surround the central through-channel or cavity 150, and effectively protect the bone graft material of the central through-channel or cavity 150 from dissipation or other erosion during the healing, bone graft solidification and bone growth of the fusion process, such as protecting the bone graft material from any of the various body fluids which would otherwise contact and erode the bone graft material before the fusion process has been completed.
As a result, in a representative embodiment, the volume of the central through-channel or cavity 150 is a significant percentage of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B). For example and without limitation, the volume of the central through-channel or cavity 150 may be in the range of about 5% to 95% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be in the range of about 10% to 90% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be in the range of about 15% to 85% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be in the range of about 20% to 85% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be in the range of about 25% to 85% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be in the range of about 30% to 85% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B), or more particularly, the volume of the central through-channel or cavity 150 may be in the range of about 35% to 85% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B), or more particularly, the volume of the central through-channel or cavity 150 may be in the range of about 40% to 85% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be in the range of about 45% to 85% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be in the range of about 50% to 85% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be in the range of about 55% to 85% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be in the range of about 60% to 85% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be in the range of about 65% to 85% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be in the range of about 70% to 85% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be in the range of about 75% to 85% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be in the range of about 75% to 80% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B).
Stated another way, also for example and without limitation, the volume of the central through-channel or cavity 150 may be greater than about 10% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be greater than about 15% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be greater than about 20% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be greater than about 25% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be greater than about 30% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be greater than about 35% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be greater than about 40% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be greater than about 45% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be greater than about 50% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be greater than about 55% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be greater than about 60% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be greater than about 70% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B); or more particularly, the volume of the central through-channel or cavity 150 may be greater than about 75% of the overall volume of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B).
In a representative embodiment, the first arcuate (or curvate) extension 115 and the second arcuate (or curvate) extension 120 are substantially solid, such as comprising plates of titanium. In another representative embodiment, the first arcuate (or curvate) extension 115 and the second arcuate (or curvate) extension 120 are substantially porous, such as comprising plates of porous titanium. In addition, any of the first and second arcuate (or curvate) extensions 115, 120 may have additional surface features and/or coatings, such as additional blind or through-holes, porosity, roughness, etching, etc., as known or becomes known, any and all of which are considered equivalent and within the scope of the disclosure, as discussed below.
For example and without limitation, each of the first arcuate (or curvate) extension 115 and the second arcuate (or curvate) extension 120 may be integrally formed, respectively, with the first transverse plate member (or endplate) 105 and the second transverse plate member (or endplate) 110, such as through casting, injection molding, stamping, 3-D printing, etc. Alternatively, also for example and without limitation, each of the first arcuate (or curvate) extension 115 and the second arcuate (or curvate) extension 120 may be formed separately and subsequently attached, respectively, to the first transverse plate member (or endplate) 105 and the second transverse plate member (or endplate) 110, such as through a laser welding process.
Those having skill in the art will also recognize that a representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B) may also utilize multiple pairs of first arcuate (or curvate) extensions 115 and second arcuate (or curvate) extensions 120 (each with a central through-channel or cavity 150).
While the first arcuate (or curvate) extension 115 and the second arcuate (or curvate) extension 120 (with the central through-channel or cavity 150) are illustrated as generally centrally located on the respective first and second transverse plate members (or endplates) 105, 110, those having skill in the art will recognize that non-central locations or arrangements may also be utilized, such as more anterior or more posterior locations, or more left or more right locations, or an asymmetric location, or multiple locations, any and all of which are considered equivalent and within the scope of the disclosure.
The first arcuate extension 115 has a first, inner surface 225 facing the central through-channel or cavity 150 and a second, outer (or external) surface 230. The second arcuate extension 120 also has first, inner surface 235 facing the central through-channel or cavity 150 and a second, outer (or external) surface 240. As mentioned above, the first and second arcuate extensions 115, 120 have mating contours which are slidable with respect to each other: more specifically, the first, inner surface 225 of the first arcuate extension 115 abuts (or contacts) and has a mating contour with the second, outer surface 240 of the second arcuate extension 120, allowing the first, inner surface 225 of the first arcuate extension 115 to be slideably moveable with respect to the second, outer surface 240 of the second arcuate extension 120, and vice-versa. Depending upon the shape and configuration of the first, inner surface 225 of the first arcuate extension 115 and the second, outer surface 240 of the second arcuate extension 120, the relative movement of the first arcuate extension 115 and the second arcuate extension 120 may be rotatable and/or pivotable in the coronal plane, the sagittal plane, and/or both the coronal and sagittal planes.
As illustrated in
Depending upon the selected embodiment, the first and second arcuate extensions 115 also overlap each other longitudinally, illustrated as overlapping regions 190. In a representative embodiment, the first and second arcuate extensions 115 are sized and shaped to continue to overlap each other throughout the entire range of articulating motion, to continue to surround the central through-channel or cavity 150 without significant interruption or external exposure of the bone graft material within the central through-channel or cavity 150, in order to maintain any bone graft material within the central through-channel or cavity 150.
Referring to
A representative extension or spacing endplate 155 has a third vertebral body contact surface 255 and may have any of a plurality of thicknesses (longitudinally), to provide adjustable and/or customizable spacing and sizing of the representative embodiments of an adjustable, implantable spinal disc device (100, 100A, 100B) for insertion between adjacent vertebral bodies 170, 175. Those having skill in the art will recognize that the extension or spacing endplate 155 may have a plurality of configurations, shapes, sizes, and contours as discussed above for the first and/or second transverse plate members (or endplates) 105, 110, any and all of which are considered equivalent and within the scope of the disclosure. In addition, a representative extension or spacing endplate 155 may have additional surface features and/or coatings, as discussed above and below, as known or becomes known, any and all of which are considered equivalent and within the scope of the disclosure.
Also for example and without limitation, the representative extension or spacing endplate 155 may be comprised of titanium or porous titanium and have a longitudinal thickness between about 0.5-10 mm, with a lateral extent and configuration selected to be an appropriate size to correspond to a selected vertebral body 170, 175.
Also as illustrated for the second representative embodiment of an adjustable, implantable spinal disc device 100A, the first and second arcuate extensions 115A, 120A do not have substantially uniform thicknesses and are not necessarily convex or concave (e.g., the second, outer surface 240 of the second arcuate extension 120A (of the anterior and posterior sides 245) is substantially rectilinear or straight and extends substantially perpendicularly from the second transverse plate member (or endplate) 110). In addition, the first, inner surface 225 of the first arcuate extension 115A and the second, outer surface 240 of the second arcuate extension 120A do not have mating contours with respect to each other. In addition, for the lateral sides 250, the first and second arcuate extensions 115A, 120A are substantially rectilinear, without convex or concave curvatures.
Also as illustrated in
As illustrated in
Accordingly, in another embodiment, the present disclosure includes a kit 300 comprising: (i) one or more first components comprising a first transverse plate member (or endplate) 105 coupled to a first arcuate (or curvate) extension 115; and (ii) one or more second components comprising a second transverse plate member (or endplate) 110 coupled to a second arcuate (or curvate) extension 120, wherein the first arcuate (or curvate) extension 115 and the second arcuate (or curvate) extension 120 have mating surfaces, as discussed above, to permitting an articulating motion (in the coronal and/or sagittal planes) of the first arcuate (or curvate) extension 115 and the second arcuate (or curvate) extension 120 with respect to each other.
In another embodiment, the kit 300 further comprises one or more fixation screws 145 for attaching the first and second transverse plate members (or endplates) 105, 110 to the corresponding adjacent vertebral bodies 170, 175.
In another embodiment, the kit 300 further comprises one or more stackable extension or spacing endplates 155 having a third vertebral body contact surface 255 and outside dimensions substantially corresponding to the outside dimensions of the first transverse plate member (or endplate) 105 and/or second transverse plate member (or endplate) 110.
As mentioned above, the various representative embodiments of an adjustable, implantable spinal disc device (100, 100A, 100B), for purposes of illustration and explanation, are shown and described as having different shapes and features, any of the various shapes, configurations, elements, materials and features may be utilized in any selection, in any combination, and in any embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B), and any and all of which selections and combinations are within the scope of the claimed invention.
The first and second transverse plate members (or endplates) 105, 110 and the first and second arcuate (or curvate) extensions 115, 120 may be constructed of any biocompatible material having sufficient strength to avoid breaking or deforming under the expected anatomical stress or loading. In any one of the embodiments described herein, the first and second transverse plate members (or endplates) 105, 110 and the first and second arcuate (or curvate) extensions 115, 120, in any combination or selection, may comprise or be manufactured from at least one of the following materials, for example and without limitation: pyrolytic carbon, titanium, porous titanium, titanium nitride, tantalum, cobalt, chromium, polyethylene, carbon fiber, PEEK® (Polyether ether ketone), Delrin® (acetal homopolymer resin), alumina, zirconia, silicon carbide, silicon nitride, stainless steel, diamond, or a diamond-like material. In certain embodiments, for example and without limitation, the first and second transverse plate members (or endplates) 105, 110 and the first and second arcuate (or curvate) extensions 115, 120 may be constructed of chrome, cobalt or titanium.
In addition, any of the various surfaces of the first and second transverse plate members (or endplates) 105, 110 and the first and second arcuate (or curvate) extensions 115, 120 may have one or more surface treatments, such as comprising a roughened, coated or porous surface. Surface roughness, (such as grit blasted, textured, porous, laser sintered, roughened porous spray titanium or as coated pyrolytic carbon); coatings (such as Hydroxyapatite); porous coatings (such as porous titanium, tantalum or silicon nitride); or porous formation (such as chemical etching of the surface); on such surface(s) are meant to promote fibrous or bony on-growth and/or ingrowth as a means of further anchoring the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B). These surface treatments are those commonly known to the industry and one skilled in the art.
In any one of the embodiments described herein, one or more of the surfaces of the first and second transverse plate members (or endplates) 105, 110 and the first and second arcuate (or curvate) extensions 115, 120 comprise a textured surface, wherein the textured surface is a roughened surface configured to receive a fixation compound. Such surfaces may be machined textured, laser finished textured surfaces, chemically treated (i.e., acid etched), or comprise a metallurgically applied coating. In some representative embodiments of an adjustable, implantable spinal disc device (100, 100A, 100B), one or more surfaces may comprise a textured surface, wherein the textured surface is a porous coating. In some embodiments, the porous coating is intended to replicate the pore structure of cancellous bone. Typical materials for textured and porous coated surfaces include: CPTi, CoCr beads, tantalum, porous PEEK, etc. In general, a coating can be configured from any chemically compatible material that will securely bond to the base material of the representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B). Alternatively, a non-articulating surface may comprise one or more fenestrations, wherein a fenestrated surface is a surface configured to receive a fixation compound, for example and without limitation.
As defined herein, a fixation compound may comprise one or more biologic or polymerizing cements. Biologic examples include morselized bone graph or paste, or any comparable bone-graft-substitute material, cells, proteins, biologic glue, tissue sealants and fibrin sealants. Examples of polymerizing cement include polymethyl methacrylate (PMMA or Plexi-glas), glue, cement, epoxy, bonding agent, fixative, paste, adhesive, adherent, binding agent, sealant, mortar, grout or any compatible synthetic, self-curing organic or inorganic material used to fill up a cavity or to create a mechanical fixation. Alternatively, the fixation compound may comprise a combination of any one of the aforementioned biologic and polymerizing cements. Fixation compounds may be used to permanently fix a representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B) to a surface of a vertebral body 170, 175; or alternately may be used to permanently bond assembled (implant) components together.
Bone grafts may be autologous or autogenous (bone harvested from the patient's own body, often from the iliac crest), allograft (cadaveric bone usually obtained from a bone bank), synthetic (often made of hydroxyapatite or other naturally occurring and biocompatible substances) with similar mechanical properties to bone, and bone morphogenic compounds and proteins. For example, demineralized bone matrix (DBM) is an allograft material devoid of mineral phase, leaving behind the organic phase comprising of an osteoconductive composite matrix of collagen and non-collagenous proteins. DBM with varying bone morphogenetic protein (BMP) content are available from the following manufacturers, for example and without limitation: Grafton (Osteotech, N.J.), musculoskeletal transplant foundation (MTF) (Synthes, Pennsylvania), and AlloMatrix (Wright Medical, Tennessee). Also for example, ceramics may be utilized for bone grafts, such as calcium sulfate [hydroxyapatite (HA) and tricalcium phosphate], bovine collagen, natural coral, calcium carbonate, or a combination of these.
Any type or kind of bone graft material may be utilized including, for example and without limitation: synthetic bone graft materials such as Actifuse®, Novabone®, chronOS™, Formagraft®, Mozaik™, Vitoss® MASTERGRAFT® Family; traditional and nontraditional allograft materials such as mineralized tissue, biocomposites (e.g., PLEXUR P® Biocomposite, PLEXUR M® Biocomposite), and demineralized tissue (e.g., Accell®, DBX®, Osteocel® Plus, PROGENIX® Family, GRAFTON® Family, MAGNIFUSE® Family, Trinity® Evolution™); and bone morphogenic compounds and proteins, including recombinant BMP-2 (rhBMP-2) along with recombinant BMP-7 (osteogenic protein-1, OP-1) and autologous growth factor concentrate (AGF) (e.g., rhBMP, rhBMP-7, rhBMP-2, OP-1® Putty/Implant, INFUSE® Bone Graft); and synthetic scaffolds and polymers, including hydrogels.
The representative embodiments of an adjustable, implantable spinal disc device (100, 100A, 100B) may be implanted using methods known to one of skill in the art. Representative surgical techniques are described in Edward C. Benzel, Spine Surgery Techniques, Complication Avoidance and Management, 3rd Ed. (Saunders, 2012); and in “Femoral Cortical Ring Plus Cancellous Dowel: An Alternative in an Interior Lumbar Interbody Fusion” available from Richard M. Salib, M.D., Institute for Low Back Care, 2800 Chicago Avenue South, Minneapolis, Minn. 55407, incorporated herein by reference.
Not separately illustrated, various inserting devices may be utilized in the surgical procedures to hold the first and second components 90, 95 together, with bone graft material within the central through-channel or cavity 150, and then implant a representative embodiment of an adjustable, implantable spinal disc device (100, 100A, 100B). In addition, also not separately illustrated, the representative embodiments of an adjustable, implantable spinal disc device (100, 100A, 100B) may have additional elements or features for use with such an inserting device, such as coupling holes or slots, for example and without limitation.
The present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the invention to the specific embodiments illustrated. In this respect, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of components set forth above and below, illustrated in the drawings, or as described in the examples. Systems, methods and apparatuses consistent with the present invention are capable of other embodiments and of being practiced and carried out in various ways.
Although the invention has been described with respect to specific embodiments thereof, these embodiments are merely illustrative and not restrictive of the invention. In the description herein, numerous specific details are provided, such as examples of electronic components, electronic and structural connections, materials, and structural variations, to provide a thorough understanding of embodiments of the present invention. One skilled in the relevant art will recognize, however, that an embodiment of the invention can be practiced without one or more of the specific details, or with other apparatus, systems, assemblies, components, materials, parts, etc. In other instances, well-known structures, materials, or operations are not specifically shown or described in detail to avoid obscuring aspects of embodiments of the present invention. In addition, the various Figures are not drawn to scale and should not be regarded as limiting.
Reference throughout this specification to “one embodiment”, “an embodiment”, or a specific “embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention and not necessarily in all embodiments, and further, are not necessarily referring to the same embodiment. Furthermore, the particular features, structures, or characteristics of any specific embodiment of the present invention may be combined in any suitable manner and in any suitable combination with one or more other embodiments, including the use of selected features without corresponding use of other features. In addition, many modifications may be made to adapt a particular application, situation or material to the essential scope and spirit of the present invention. It is to be understood that other variations and modifications of the embodiments of the present invention described and illustrated herein are possible in light of the teachings herein and are to be considered part of the spirit and scope of the present invention.
For the recitation of numeric ranges herein, each intervening number there between with the same degree of precision is explicitly contemplated. For example, for the range of 6-9, the numbers 7 and 8 are contemplated in addition to 6 and 9, and for the range 6.0-7.0, the number 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, and 7.0 are explicitly contemplated. In addition, every intervening sub-range within range is contemplated, in any combination, and is within the scope of the disclosure. For example, for the range of 5-10, the sub-ranges 5-6, 5-7, 5-8, 5-9, 6-7, 6-8, 6-9, 6-10, 7-8, 7-9, 7-10, 8-9, 8-10, and 9-10 are contemplated and within the scope of the disclosed range.
It will also be appreciated that one or more of the elements depicted in the Figures can also be implemented in a more separate or integrated manner, or even removed or rendered inoperable in certain cases, as may be useful in accordance with a particular application. Integrally formed combinations of components are also within the scope of the invention, particularly for embodiments in which a separation or combination of discrete components is unclear or indiscernible. In addition, use of the term “coupled” herein, including in its various forms such as “coupling” or “couplable”, means and includes any direct or indirect electrical, structural or magnetic coupling, connection or attachment, or adaptation or capability for such a direct or indirect electrical, structural or magnetic coupling, connection or attachment, including integrally formed components and components which are coupled via or through another component.
Furthermore, any signal arrows in the drawings/Figures should be considered only exemplary, and not limiting, unless otherwise specifically noted. Combinations of components of steps will also be considered within the scope of the present invention, particularly where the ability to separate or combine is unclear or foreseeable. The disjunctive term “or”, as used herein and throughout the claims that follow, is generally intended to mean “and/or”, having both conjunctive and disjunctive meanings (and is not confined to an “exclusive or” meaning), unless otherwise indicated. As used in the description herein and throughout the claims that follow, “a”, “an”, and “the” include plural references unless the context clearly dictates otherwise. Also as used in the description herein and throughout the claims that follow, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.
The foregoing description of illustrated embodiments of the present invention, including what is described in the summary or in the abstract, is not intended to be exhaustive or to limit the invention to the precise forms disclosed herein. From the foregoing, it will be observed that numerous variations, modifications and substitutions are intended and may be effected without departing from the spirit and scope of the novel concept of the invention. It is to be understood that no limitation with respect to the specific methods and apparatus illustrated herein is intended or should be inferred. It is, of course, intended to cover by the appended claims all such modifications as fall within the scope of the claims.
This application is a U.S. national phase under 35 U.S.C. Section 371 and claims the benefit of and priority to International Application No. PCT/US2016/051808 filed Sep. 15, 2016, inventor Sergey Y. Neckrysh, titled “Adjustable, Implantable Spinal Disc Device for Deformity Correction in Intervertebral Fusion Procedures”, which is a nonprovisional of and claims the benefit of and priority to U.S. Provisional Patent Application No. 62/220,301, filed Sep. 18, 2015, inventor Sergey Neckrysh, titled “Surgical Implant Device”, which is commonly assigned herewith, and all of which is hereby incorporated herein by reference in their entireties with the same full force and effect as if set forth in their entireties herein.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US16/51808 | 9/15/2016 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62220301 | Sep 2015 | US |
