US20050113924A1 - Apparatus and method for performing spinal surgery - Google Patents
Apparatus and method for performing spinal surgery Download PDFInfo
- Publication number
- US20050113924A1 US20050113924A1 US10/913,510 US91351004A US2005113924A1 US 20050113924 A1 US20050113924 A1 US 20050113924A1 US 91351004 A US91351004 A US 91351004A US 2005113924 A1 US2005113924 A1 US 2005113924A1
- Authority
- US
- United States
- Prior art keywords
- compressible
- vertebral body
- prosthetic device
- intervertebral
- fixation
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
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- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Medical Informatics (AREA)
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- Transplantation (AREA)
- Cardiology (AREA)
- Neurology (AREA)
- Prostheses (AREA)
Abstract
An embodiment of an intervertebral prosthetic device for implantation in a spine includes a rigid fixation member and a compressible member. The fixation member is configured to be placed in a cavity of a first vertebral body and against bone of the first vertebral body. The compressible member is configured to be placed in a cavity in an intervertebral disc and to be secured to the first fixation member. Another embodiment includes two compressible members and one fixation member. In this embodiment, the first and second compressible members are sized to substantially replace the nucleus pulposus of first and a second intervertebral discs, respectively, on either side of a vertebral body. The fixation member is sized to fit within a cavity in the vertebral body between the first and second compressible members.
Description
- This invention claims priority to co-pending U.S. Provisional Patent Application Nos. 60/492,966 (filed Aug. 7, 2003) and 60/512,186 (filed Oct. 20, 2003).
- This invention relates to the field of spinal surgery. More specifically, this invention relates to a novel implantable apparatus for replacing the functionality of one or more failing intervertebral discs, without fusing the vertebral bodies above and below the disc(s). This invention also relates to devices for implanting and securing the intervertebral prosthetic device in cavities in a vertebral body and in one or more adjacent intervertebral discs. The invention further relates to methods for performing spinal surgery.
- The human spine is a flexible structure comprised of twenty-three mobile vertebrae. Intervertebral discs separate and cushion adjacent vertebrae. The top and bottom surfaces of intervertebral discs abut vertebral body endplates. The intervertebral discs act as shock absorbers and allow bending between the vertebrae.
- An intervertebral disc comprises two major components: the nucleus pulposus and the annulus fibrosis. The nucleus pulposus is centrally located in the disc and occupies 25-40% of the disc's total cross-sectional area. The nucleus pulposus usually contains 70-90% water by weight and mechanically functions like an incompressible hydrostatic material. The annulus fibrosis surrounds the nucleus pulposus and resists torsional and bending forces applied to the disc. Thus, the annulus fibrosis serves as the disc's main stabilizing structure. A healthy disc relies on the unique relationship of the nucleus and annulus to one another.
- Individuals with damaged or degenerated discs often experience significant pain. The pain results, in part, from instability in the intervertebral joint due to a loss of hydrostatic pressure in the nucleus pulposus, which leads to a loss of disc height and altered loading of the annulus fibrosis.
- A conventional treatment for degenerative disc disease is spinal fusion. In one such surgical procedure, a surgeon removes the damaged natural disc and then fuses the two adjacent vertebral bodies into one piece. The surgeon fuses the vertebral bodies by grafting bone between the adjacent vertebrae and sometimes using metal rods, cages, or screws to hold the graft in place until the graft heals.
- Although spinal fusion may alleviate pain associated with degenerative disc disease, it also results in loss of motion at the fused vertebral joint. Lack of motion at the fused site puts additional stress on the discs above and below the fusion. The additional stress may cause the adjacent discs to degenerate and produce pain, thereby recreating the original problem.
- To remedy the problems associated with spinal fusion, various prosthetic devices have been developed either to replace the entire disc (i.e., the nucleus pulposus and the annulus fibrosis) with a prosthetic joint or to replace the nucleus pulposus of the damaged disc with a suitable biomechanical equivalent. Unfortunately, the previous approaches have certain limitations because conventional total disc replacement devices and nucleus replacement devices disrupt tissues that will not heal.
- In the case of total disc replacement surgery, existing prosthetic devices have met with limited success in reproducing the biomechanics of a natural disc. Moreover, the anterior longitudinal ligament must be severed as part of the anterior approach by which the device is implanted. Worse, the severing may span two vertebral bodies for a two level reconstruction, which can lead to lessened spinal function and stability. Further, total disc replacement devices require removal of a substantial portion the disc and attachment to the adjacent vertebral bodies. The endplates of the vertebral bodies are nonuniform and typically sclerotic, which prevents the close physical joining of endplate and device surfaces required for bone ingrowth to provide adhesion and can lead to subsidence of the disc replacement device into the bone of the vertebral bodies if the endplates are shaved for contour matching. Moreover, the devices display limited motion. Specifically, as a result of the oversized implant relative to the narrow disc space, total disc replacement often results in a range of motion of only about 3.8° to 4.6°. Such a limited range of motion is the equivalent of a spinal fusion, which is defined to be motion of less than about 5°.
- For example, U.S. Pat. No. 4,759,769 to Hedman et al. discloses a synthetic disc having upper and lower plates hinged together. Although the hinged disc allows forward bending between adjacent vertebrae, the hinged disc does not allow axial compression or lateral flexion. Nor does it allow axial rotation of the vertebral column at the site of the implant. Therefore, the Hedman et al. device lacks the biomechanics of a natural disc.
- Likewise, the prosthetic disc device disclosed in U.S. Pat. No. 4,309,777 to Patil does not replicate natural motion between adjacent discs. The Patil device includes two cups, one of which overlaps the other and is spaced from the other by springs. The cups move only in a single axial dimension. Thus, the Patil device does not enable natural flexion of the spine in any direction. In addition, the highly constrained motion of the Patil device can lead to high device/tissue interface stresses and implant loosening.
- In the case of nucleus replacement devices, historically these devices required perforation or partial excision of the annulus to insert the device. Breaking the continuity of the annular ring precludes normal stress loading of the annulus, which may be necessary for later healing. Further, degeneration of the annulus, exacerbated by damage done during implantation, may also result in increased loads placed upon the implant. Increased loads of this nature may lead to subsidence of the device into the vertebral body, device extrusion through the annular defect, or expulsion from the nuclear space. Moreover, these problems are exacerbated in the situation in which more than one disc is to be replaced because any or all of the devices may develop these problems. These problems are particularly challenging in the lumbar spine, where the discs are most highly stressed due to high bearing requirements.
- A remarkable intervertebral synthetic prosthetic device that greatly reduces the problems associated with total disc replacement and conventional nucleus replacement devices is disclosed in U.S. Pat. No. 5,827,328 (“the '328 patent”) to Buttermann. The Buttermann devices excise the nucleus pulposus while maintaining the biomechanical functionality of the intact annulus fibrosis. Moreover, the intervertebral prosthetic device permits at least four degrees of relative motion between two vertebral bodies on either side of targeted intervertebral disc. These degrees of relative motion include sagittal bending, coronal bending, axial rotation, and axial compression. Moreover, the compressible member permits small increments of translational movement between the vertebral bodies (i.e., fifth and sixth degrees of relative motion, namely anterior-posterior translation and side-to-side, or lateral, translation).
-
FIG. 1 shows an embodiment of an intervertebralprosthetic device 10 according to one embodiment of the '328 patent that is designed to replace a damaged natural disc. Thisdevice 10 is implanted by making holes in two adjacent vertebral bodies and boring through the nucleus pulposus of the intervertebral disc between the vertebral bodies. Theintervertebral prosthetic device 10 has afirst fixation member 14, asecond fixation member 16, and acompressible member 18 that is positioned between thefirst fixation member 14 and thesecond fixation member 16. In addition to restoring the disc height, thecompressible member 18 acts as a shock absorber to minimize impact loading and, thus, minimize device failure or vertebral fracture. - The
first fixation member 14 is positioned in a firstvertebral body 20. Thesecond fixation member 16 is positioned within a secondvertebral body 22 adjacent the firstvertebral body 20. Eachfixation member adjustable member support member adjustable members - The
adjustable member 28 of thefirst fixation member 14 has an imaginary first longitudinal axis (shown by double-arrowed line A-A inFIG. 1 ) andadjustment elements 24 that allow adjustment of the height of theadjustable member 28 substantially along its longitudinal axis. In the embodiment shown inFIG. 1 , thesecond fixation member 16 is structurally similar to thefirst fixation member 14, but inverted. Theadjustable member 30 of thesecond fixation member 16 has a second longitudinal axis (shown by double-arrowed line B-B) andadjustment elements 26 that allow adjustment of the height of theadjustable member 30 substantially along its longitudinal axis. -
FIG. 4 shows one embodiment of thefirst fixation member 14. In the embodiment shown inFIG. 1 , thesecond fixation member 16 is structurally similar to thefirst fixation member 14, but inverted. Thus, the following discussion also applies to thesecond fixation member 16. - The
adjustable member 28 of thefirst fixation member 14 is adjustable in an axial direction byadjustment elements 24. Theadjustment elements 24 comprise telescopic struts extending between a first,outer plate 31 and a second,inner plate 33. Theouter plate 31 is farther from the operative intervertebral disc and hence farther from thecompressible member 18. In contrast, theinner plate 33 is closer to the operative intervertebral disc area and hence closer to thecompressible member 18. In the embodiment illustrated inFIG. 1 , theouter plate 31 has a bone-contactingsurface 27, and theinner plate 33 has asurface 35 for positioning against thesupport member 32. - The
adjustment elements 24 adjust the distance between the first bone-contactingplate 31 and thesecond plate 33, thus adjusting the height of theadjustable member 28. A surgeon may adjust the telescopic struts to increase the height of the adjustable member and thus mechanically pre-load thecompressible member 18 to reproduce the axial compression absorbed by a nucleus pulposus of a natural disc. Pre-loading the compressible member restores the intervertebral height at the operative joint, restores the function of the annulus fibrosis. Pre-loading also assures close apposition of aningrowth surface bone - Each telescopic strut is provided with a
lock screw 63 to adjust the length of thestrut 24 and hence control the height of the adjustable member. Thelock screw 63 may comprise, for example, a pin (not shown) that extends through both thetelescoping portion 65 and thehousing portion 67 of thestrut 24. Eachstrut 24 is independently adjustable.FIG. 5 shows a top view of thesecond plate 33 of theadjustable member 28. Theadjustment elements 24 preferably are spaced equidistant from each other to enable specific height adjustment of various regions of the adjustable member. - The first and
second fixation members surface 27, to permit bone ingrowth. InFIG. 1 , the bone-contactingsurface 27 of theadjustable member 28 is positioned against the subchondral bone of anendplate 36 of the superiorvertebral body 20, and the bone-contactingsurface 29 of theadjustable member 30 is positioned against the subchondral bone of anendplate 38 of the inferiorvertebral body 22. Alternatively, a biocompatible fabric or suitable material may be wrapped around the fixation members to enable bone ingrowth. As another alternative, a biocompatible coating may be applied to the fixation members to facilitate bone ingrowth. The prosthetic device ofFIG. 1 does not require conventional mechanical attachments, such as pegs or screws, to hold the prosthesis permanently in place. The intravertebral (i.e., within a vertebral body) positioning of thefixation members prosthetic device 10 in stable relationship at the operative intervertebral joint. The prosthetic device, however, may include mechanical or other attachments to supplement the porous portions of the fixation members and to temporarily fix the prosthetic device in place until bone ingrowth has occurred. - To further promote bone ingrowth, the
adjustment elements 24 may includefins 66 extending outward from an exterior surface of theelement 24, as shown inFIG. 4 . Thefins 66 increase the surface area of thefixation member 14 to which bone may attach. Preferably, thesefins 66 are located on the adjustment elements that are positioned on the anterior side of theadjustable member 28. The prosthetic device also may include protuberances (not shown) on the bone-contacting surface of the adjustable members to increase the surface area of the porous portion of the fixation members and, thus, encourage bone ingrowth. -
FIG. 6 shows a cross-section ofsupport member 32. Thesupport member 32 has afirst surface 72 that operably faces away from thecompressible member 18 and asecond surface 74 that operably faces towards thecompressible member 18. The first andsecond surfaces circumferential surface 77 around thesupport member 32 varies in width, as shown inFIG. 4 . Thus, thesupport member 32 is wedge-shaped. In other words, thesupport member 32 preferably tapers from a maximum thickness at oneside 73 to a minimum thickness at anopposite side 75. Generally, thesupport member 32 is thicker on the side of thefixation member 14 placed anteriorly in a patient's spine to account for the spine's natural curvature. - The support members are constructed with various thicknesses and with various angled surfaces, depending upon the vertebral level of the operative intervertebral joint. An angle θ shown in
FIG. 6 ranges between 3°-10°. The support members are shaped to maintain sagittal alignment. Maintaining sagittal alignment avoids nonuniform loading of the compressible member and avoids early fatigue failure of that member. - The
compressible member 18, which is shown inFIG. 2 , can comprise at least one spring and, in the illustrated embodiment, comprises a plurality ofsprings 40. Thecompressible member 18, which is implanted in the region of an excavated nucleus pulposus of the operative intervertebral disc, is dimensioned so that the annulus fibrosis of the natural disc is at least substantially (if not completely) maintained. As a result, the intervertebral prosthetic device restores the mechanical properties of the disc without disrupting the annulus fibrosis. Retention of the annulus fibrosis maintains stability of the intervertebral joint at the implant site. In addition, the annulus fibrosis serves as a boundary for the compressible member and, therefore, minimizes the potential for accidental dislodgment of the prosthetic device. - The
compressible member 18 has atop plate 42, abottom plate 44, and a plurality ofcoil springs 40 extending between thetop plate 42 and thebottom plate 44. Thetop plate 42 has a first surface 46, which is connectable to thefirst fixation member 14, and asecond surface 48. Thebottom plate 44 also has afirst surface 50, which is connectable to thesecond fixation member 16, and asecond surface 52. Thesprings 40 extend between thesecond surfaces top plate 42 andbottom plate 44, respectively. - When pre-loaded, the
compressible member 18 can have an axial height of approximately 1.5 cm, greatest at the L45 vertebral level and slightly less at the upper lumbar vertebrae. The coil springs 40 can have non-linear stiffness so that they become stiffer at higher applied loads; the nonlinear stiffness simulates physiological intervertebral stiffness. Moreover, any spring arrangement may be used that achieves sufficient axial compressive stiffness to replicate the biomechanics of the natural disc. - The compressible member includes an imaginary longitudinal axis (shown by the dashed line C-C) and an outer periphery in a plane transverse to its longitudinal axis. A largest dimension of the compressible member's outer periphery is less than or substantially equal to the diameter of a nucleus pulposus of the natural intervertebral disc. Put another way, the annulus fibrosis of the natural disc, which is substantially (if not completely) preserved during the implantation procedure, circumscribes the
compressible member 18. For example, where the compressible member comprises a plurality of springs, the outer periphery of the compressible member circumscribes the springs, and the largest dimension of that outer periphery may extend to, but does not extend beyond, the nucleus pulposus. In other embodiments, where the compressible member includes a top plate and a bottom plate, and where those plates fit within the annulus fibrosis and extend beyond the outermost portions of the springs, the outer periphery of the compressible member equals the larger of the two plate peripheries. In quantitative terms, the outer periphery of the compressible member preferably ranges between 2.0 cm to 3.0 cm, which approximates the diameter of the nucleus pulposus of a natural intervertebral disc. -
FIGS. 3A-3C show three embodiments of a coil spring designed to possess non-linear stiffness. In the embodiment ofFIG. 3A , thecoil spring 54 has a variable, or non-uniform,cross-sectional diameter 56.FIG. 3B shows another embodiment in which acoil spring 58 has avariable pitch 60, where the pitch is defined as the distance between successive coils of thespring 58.FIG. 3C shows a third embodiment of acoil spring 62 in which at least two of the spring coils havedifferent radii 64 measured from an imaginary axis D-D extending along the central axis of thespring 62. - A method of intervertebral disc replacement now will be described in connection with
FIGS. 8-14 .FIG. 8 shows a pathologicalintervertebral disc 90 located between a superiorvertebral body 92 and an inferiorvertebral body 94. Prior to implantation, a surgeon performs a partial vertebrectomy to excise bone matter from the superiorvertebral body 92 for receipt of a fixation member. This procedure can be performed using a cutting guide and reamer. Bone harvested from thevertebral body 92 by the reamer can be used after implantation of the prosthetic device to promote bone ingrowth into the prosthetic device, as later described. The partial vertebrectomy creates a cavity bounded by subchondral bone of adistant endplate 96 and subchondral bone of anear endplate 98 of the superiorvertebral body 92.FIG. 9 shows a cross-sectional view of the superiorvertebral body 92 after the partial vertebrectomy, as taken along line 9-9 inFIG. 8 . - The surgeon next excises the nucleus pulposus of the damaged disc to create a
cavity 100, as shown inFIG. 10 , for receipt of the compressible member. Theannulus fibrosis 102, seen inFIG. 11 , is maintained. - Upon completion of the partial vertebrectomies, the surgeon implants a
fixation member 104 into the inferiorvertebral body 94, as shown inFIG. 11 . The surgeon can select a support member with an appropriate thickness to accommodate the angulation at the operative intervertebral levels. The surgeon then inserts a compressible member 106 (via the cavity formed in the superior vertebral body 92) into the cavity formerly containing the nucleus pulposus of the damaged disc and connects it to theinferior fixation member 104, as shown inFIG. 12 . Thecompressible member 106 and thefixation member 104 may be connected by conventional attachment members, such as screws, or by biocompatible cement or a suitable adhesive composition. Finally, the surgeon implants another fixation member, similar to the one implanted in the inferiorvertebral body 94, yet inverted, in the superiorvertebral body 92. Connection of that fixation member to thecompressible member 106 forms an intervertebral prosthetic device like the one shown inFIG. 1 . - Once the fixation members are in place, the surgeon expands each adjustable member. The surgeon applies distraction until the adjustable member is seated against the subchondral bone and
distant endplate 96 of the vertebral body and until the desired compression has been applied to the compressible member. The adjustment elements of the adjustable member are then secured, e.g.,FIG. 13 shows rotation of the lock screws 112 of individualtelescopic struts 108 to secure the struts at an appropriate height. - The surgeon next packs
cancellous bone grafts 118, typically obtained during creation of the cavity in the vertebral body, around the struts of each adjustable member, as shown inFIG. 14 . The growth of bone around the fixation member and into its porous surfaces secures the intervertebral prosthetic device in place, absent mechanical attachments typically used in conventional disc prostheses. The surgeon then replaces the cortical bone from the partial vertebrectomy procedure and, if needed, secures it with a bone screw, suture or bone cement. In certain clinical situations, as when there is poor bone healing or insufficient bone, the surgeon may elect to use bone cement to attach the fixation members to the vertebrae. - Although the embodiment shown in
FIGS. 1-6 is effective, in some instances it may be unnecessarily invasive as a result of its implantation via two vertebral body holes.FIG. 7 shows a second, less invasive embodiment described in the '328 patent, in which a prosthetic device is implanted via one vertebral body hole. -
FIG. 7 shows an intervertebralprosthetic device 76 according to this second embodiment that comprises afirst fixation member 78, asecond fixation member 80, and acompressible member 82. Thecompressible member 82 is positioned between the first andsecond fixation members second fixation member 80 comprises a wedge-shaped support member with anupper surface 84 that attaches to thecompressible member 82 and alower surface 86 that rests upon subchondral bone of anear endplate 88 of an inferior vertebral body. In this embodiment, adjustment of thefirst fixation member 78 pre-loads thecompressible member 82 to an appropriate extent. Also, in this embodiment, alower surface 86 of thesupport member 80 may be composed of a porous material and may have a slightly convex shape to match the natural contour of the near endplate of the inferior vertebral body. - The implantation of the
FIG. 7 embodiment is similar to the implantation of theFIG. 1 embodiment. Specifically, similar to the embodiment shown inFIG. 10 , a cavity may be formed in the superiorvertebral body 92 and then extended through the nucleus pulposus of the intervertebral disc therebelow. At this time, the compressible member with thelower fixation member 80 affixed thereto may be inserted through the cavity in the vertebral body and then pushed downward into thecavity 100 in the intervertebral disc. Subsequently, theupper fixation member 78 is: (a) positioned in the cavity formed in the superiorvertebral body 92; (b) connected to the compressible member; and (c) adjusted in the manner previous discussed with respect to theFIG. 1 embodiment. Of course, the cavity in the superiorvertebral body 92 is then closed also in the manner previously described. - As evident from the embodiments of
FIGS. 1 and 7 , the intervertebral prosthetic device embodiments have a modular design so that the prosthesis may be sized to the patient's anatomy and designed for the patient's condition. The modular design also enables replacement of individual components of the prosthesis (i.e., a fixation member or a compressible member), rather than replacement of the entire prosthesis should one component fail. As a result, the compressible member can be attached to the fixation members by mechanical attachments, such as screws, rather than bone cement so that a surgeon may easily replace damaged or worn components. - Unfortunately, the embodiment shown in
FIG. 1 precludes use when reconstructing multiple adjacent discs. Additionally, although the less invasive embodiment shown inFIG. 7 may be implanted via only one vertebral body hole, it may be less effective than the embodiment shown inFIG. 1 when used in patients with low bone density. Specifically, theFIG. 7 may be less effective as a result of inability to adequately fix thelower fixation member 80 to the vertebral body below the compressible member. Further, this inability to adequate fix thelower fixation member 80 may, in turn, lead to subsidence of the device into the vertebral body adjacent thelower fixation member 80. - An embodiment of the invention addresses a prosthetic device that includes: a first compressible member sized to substantially replace the nucleus pulposus of a first intervertebral disc; a second compressible member sized to substantially replace the nucleus pulposus of a second intervertebral disc that is separated from the first intervertebral disc by a vertebral body; and a fixation member sized to fit within a cavity in the vertebral body between the first and second compressible members.
- Another embodiment of the invention addresses a prosthetic device that includes: a fixation member sized to fit within a cavity in a first vertebral body; and a compressible member sized to substantially replace a nucleus pulposus of an intervertebral disc adjacent the vertebral body. A first side of the compressible member is configured to engage the fixation member and a second side of the compressible member is configured to engage a second vertebral body. The second side of the compressible member is configured to fit within a seat formed in the cortical bone of the endplate of the second vertebral body.
- Another embodiment of the invention addresses an intervertebral prosthetic device for implantation in a spine that includes: (a) a rigid fixation member having a fixed length, the rigid fixation member being configured to be placed in a cavity of a vertebral body and against bone of the vertebral body; and (b) a first compressible member configured to be placed in a cavity in a first intervertebral disc adjacent the vertebral body and to be secured to the rigid fixation member. The compressible member is constructed to remain compressible after implantation and has at least one compressible element that remains compressible after implantation. The rigid fixation member is sized to compress the compressible member a predetermined amount when the rigid fixation member and the first compressible member are placed in the cavity in the first vertebral body and in the cavity in the first intervertebral disc, respectively.
- Another embodiment of the invention addresses an intervertebral prosthetic device for implantation in a spine. This device includes: (a) a fixation member configured to be placed in a cavity of a vertebral body, the fixation member including: (i) an outer member configured to be placed against bone of the vertebral body; (ii) an inner member opposite the outer member; and (iii) at least one adjustment element that extends between the outer and inner members and that is configured to adjust a length dimension of the fixation member along its longitudinal axis; (b) a compressible member configured to be placed in a cavity in an intervertebral disc adjacent the vertebral body and configured to be secured to the inner member of the fixation member; and (c) a spacer sized to fit between the outer and inner members of the fixation member to maintain the fixation member at a desired length dimension.
- Another embodiment of the invention addresses an intervertebral prosthetic device for implantation in a spine. This device includes: (a) a fixation member configured to be placed in a cavity of a vertebral body, the fixation member including: (i) an outer member configured to be placed against bone of the vertebral body; (ii) an inner member opposite the outer member; and (iii) a longitudinal axis extending between the outer and inner members; and (b) a compressible member configured to be placed in a cavity in an intervertebral disc and to be secured to the inner member of the fixation member. The compressible member is constructed to remain compressible after implantation. The outer member includes a tab extending outward along an axis different from the longitudinal axis.
- Another embodiment of the invention addresses an intervertebral prosthetic device for implantation in a spine. This device includes: (a) a fixation member configured to be placed in a cavity of a vertebral body, the fixation member including: (i) an outer member configured to be placed against bone of the vertebral body; (ii) an inner member opposite the outer member; and (iii) a longitudinal axis extending between the outer and inner members; (b) a compressible member configured to be placed in a cavity in an intervertebral disc adjacent the vertebral body and to configured be secured to the fixation member; and (c) at least one anchor element configured to immobilize and/or stabilize the compressible member and/or the fixation member.
- Another embodiment of the invention addresses a prosthetic device that includes: (a) a fixation member sized to fit within a cavity in a first vertebral body; and (b) a compressible member that includes: (i) a cup-shaped base member; (ii) an upper member; and (iii) one or more compressible elements provided between the base member and the upper member. The compressible member is sized to substantially replace a nucleus pulposus of an intervertebral disc adjacent the vertebral body.
- Another embodiment of the invention addresses a prosthetic device that includes: (a) a fixation member sized to fit within a cavity in a first vertebral body; and (b) a compressible member that includes: (i) a base member; (ii) an upper member that includes a spike; and (iii) one or more compressible elements provided between the base member and the upper member. The one or more compressible elements are sized to substantially replace a nucleus pulposus of an intervertebral disc adjacent the vertebral body.
- Another embodiment of the invention addresses a prosthetic device that includes: (a) a fixation member sized to fit within a cavity in a first vertebral body; and (b) a compressible member that includes: (i) a base member; (ii) an upper member comprising a ball-and-socket joint; and (iii) one or more compressible elements provided between the base member and the upper member. The compressible member is sized to substantially replace a nucleus pulposus of an intervertebral disc adjacent the vertebral body.
- Another embodiment of the invention addresses a prosthetic device that includes: (a) a fixation member sized to fit within a cavity in a first vertebral body; and (b) a compressible member that includes: (i) a base member; (ii) an upper member; and (iii) one or more compressible elements provided between the base member and the upper member. The compressible member is sized to substantially replace a nucleus pulposus of an intervertebral disc adjacent the vertebral body. The base member is adjustable in a radial direction.
- Another embodiment of the invention addresses a method of spinal prosthetic implantation. This method includes: (a) creating a cavity in a first vertebral body; (b) cutting a first hole through either a lower or an upper endplate of the vertebral body and through the nucleus pulposus of a first intervertebral disc adjacent thereto, thereby creating a first opening in the first intervertebral disc; (c) cutting a second hole through the other of the lower and upper endplate of the vertebral body and through the nucleus pulposus of a second intervertebral disc adjacent thereto, thereby creating a second opening in the second intervertebral disc; (d) implanting a first compressible member into one of the first and second openings; (e) implanting a second compressible member into the other of the first or second openings; and (f) implanting a fixation member into the cavity in the first vertebral body.
- Another embodiment of the invention addresses a method of spinal prosthetic implantation. This method includes: (a) creating a cavity in a first vertebral body; (b) cutting through an endplate of the vertebral body and through the nucleus pulposus of an adjacent intervertebral disc, thereby creating an opening in the intervertebral disc; (c) cutting into the cortical bone of a second vertebral body on the other side of the intervertebral disc to create a seat; (d) implanting a compressible member into the opening in the intervertebral disc such that a distal end of the compressible member sits within the seat in the second vertebral body; and (e) implanting a fixation member in the cavity in the first vertebral body.
- Another embodiment of the invention addresses a method of spinal prosthetic implantation. This method includes: (a) creating a cavity in a vertebral body; (b) cutting a hole through either a lower or an upper endplate of the vertebral body and through the nucleus pulposus of an intervertebral disc adjacent thereto, thereby creating an opening in the intervertebral disc; (c) implanting a compressible member into the opening in the intervertebral disc; and (d) implanting a fixation member into the cavity in the first vertebral body. The compressible member comprises a base member that is wider than the hole cut in the vertebral body through which the first compressible member is implanted. The step of implanting the compressible member into the opening includes: (i) maneuvering the base member of the compressible member so that it passes through the hole and into the opening; and (ii) rotating the base member so that it substantially covers the hole.
- Another embodiment of the invention addresses a method of spinal prosthetic implantation. This method includes: (a) creating a cavity in a vertebral body; (b) cutting a hole through either a lower or an upper endplate of the vertebral body and through the nucleus pulposus of an intervertebral disc adjacent thereto, thereby creating an opening in the intervertebral disc; (c) implanting a compressible member into the opening in the intervertebral disc; and (d) implanting a fixation member into the cavity in the first vertebral body. The compressible member comprises a base member that is radially adjustable to be wider than the hole cut in the vertebral body through which the compressible member is implanted. The step of implanting the compressible member into the opening includes: (i) maneuvering the base member of the compressible member so that it passes through the hole and into the opening; and (ii) radially adjusting the base member so that it substantially covers the hole.
- Another embodiment of the invention addresses a drill guide for use in spinal surgery. The drill guide includes a body having a first leg and a second leg. The first leg is dimensioned to be fixed relative to an intervertebral prosthetic member mounted in a cavity of a first vertebral body. The second leg is dimensioned to extend from the first leg, adjacent the first vertebral body, to a free end, adjacent at least one of an intervertebral disc and a second vertebral body. The second leg includes at least one drilling channel extending through the second leg and the free end of the second leg comprises a drill positioning block through which the at least one drilling channel extends.
- It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.
- The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate a presently preferred embodiment of the invention, and, together with the general description given above and the detailed description of the preferred embodiment given below, serve to explain the principles of the invention.
-
FIG. 1 is a schematic, cut-away side view of a prior art intervertebral prosthetic device implanted in a spine. -
FIG. 2 is a top perspective view of a compressible member of the intervertebral prosthetic device ofFIG. 1 . -
FIGS. 3A-3C are top perspective views of different embodiments of a spring of the compressible member shown inFIG. 1 . -
FIG. 4 is a top perspective, partially exploded view of a fixation member of the intervertebral prosthetic device ofFIG. 1 and shows an adjustable member and a support member. -
FIG. 5 is a top view of a plate of the adjustable member shown inFIG. 1 . -
FIG. 6 is a side view, in cross-section, of the support member shown inFIG. 1 . -
FIG. 7 is a schematic, cut-away side view of another prior art intervertebral prosthetic device implanted in a spine. -
FIG. 8 is a schematic, cut-away side view showing subchondral bones of a superior vertebral body after a partial vertebrectomy. -
FIG. 9 is a sectional view of a vertebra after creating a cavity within the vertebral body, as taken along line 9-9 ofFIG. 8 . -
FIG. 10 is a schematic, cut-away side view of a vertebral joint area after creating a cavity within the vertebral body and excision of a nucleus pulposus of a natural disc. -
FIG. 11 is a schematic, cut-away side view of a vertebral joint and shows a fixation member, including an adjustable member and a support member, implanted in an inferior vertebral body. -
FIG. 12 is a schematic, cut-away side view of a vertebral joint and shows a compressible member implanted in an intervertebral joint. -
FIG. 13 is a schematic, cut-away side view of a vertebral joint and shows a technique for adjusting the height of an adjustable member implanted in a superior vertebral body. -
FIG. 14 is a schematic, cut-away side view of a vertebral joint and shows a technique for bone grafting an adjustable member in a superior vertebral body. -
FIG. 15A is a top perspective view of an intervertebral prosthetic device and a drill guide used to drill holes in the intervertebral bone in accordance with the invention;FIGS. 15B-15D are a first side elevation view, a second side elevation view, and a top plan view, respectively, of the intervertebral prosthetic device and the drill guide ofFIG. 15A . -
FIGS. 16A-16D are a top perspective view, a first side elevation view, a second side elevation view, and a top plan view, respectively, of the drill guide ofFIG. 15A . -
FIG. 17A is a top perspective view of the intervertebral prosthetic device and the drill guide ofFIG. 15A , showing placement of anchor elements through the drill guide and a compressible member of the intervertebral prosthetic device;FIGS. 17B-17D are a first side elevation view, a second side elevation view, and a top plan view, respectively, of the intervertebral prosthetic device, including the anchor elements, and the drill guide ofFIG. 17A . -
FIG. 18A is a side elevation view of an intervertebral prosthetic device, including anchor elements, and a drill guide in accordance with another embodiment of the invention;FIGS. 18B-18D are a top perspective view, a side elevation view, and a top plan view, respectively, of the intervertebral prosthetic device, including the anchor elements, and the drill guide ofFIG. 18A . -
FIGS. 19A-19E are a top perspective view, a bottom plan view, a bottom perspective view, a first side elevation view, and a second side elevation view, respectively, of a plate of an embodiment of a fixation member in accordance with the invention. -
FIG. 20 is a sectional view of a vertebra, including a plate, as shown inFIGS. 19A-19E , implanted in the vertebra. -
FIG. 21A is a top perspective view of an intervertebral prosthetic device, including anchor elements and spacers, in accordance with another embodiment of the invention;FIGS. 21B-21D are a first side elevation view, a second side elevation view, and a top plan view, respectively, of the intervertebral prosthetic device, including the anchor elements and the spacers, ofFIG. 21A . -
FIG. 22A is a top perspective view of an intervertebral prosthetic device, including spacers, in accordance with another embodiment of the invention;FIGS. 22B-22D are a first side elevation view, a second side elevation view, and a top plan view, respectively, of the intervertebral prosthetic device, including the spacers, ofFIG. 21A . -
FIGS. 23A-23D are a top perspective view, a first side elevation view, a second side elevation view, and a top plan view, respectively, of a spacer. -
FIG. 24 is a front perspective view of another embodiment of an implantable prosthetic device; the device be shown in a break-away view of a spine. -
FIG. 25 is a top perspective view of the implantable device ofFIG. 24 . -
FIG. 26 is a side perspective view of the implantable device ofFIG. 24 . -
FIG. 27 is another side perspective view of the implantable device ofFIG. 24 . -
FIG. 28 is a perspective view of the implantable device ofFIG. 24 having anchor elements therethrough. -
FIGS. 29A and 29B are respective cross-sectional and perspective views of an alternate embodiment compressible member;FIGS. 29C and 29D are respective cross-sectional and perspective views of another alternate embodiment compressible member; andFIG. 29E is a cross-sectional view of either of the embodiments shown inFIGS. 29A-29D implanted in an intervertebral disc. -
FIGS. 30A and 30B are cross-sectional views of another alternate embodiment compressible member in whichFIG. 30A shows the compressible member partial implanted andFIG. 30B shows the compressible member completely implanted;FIGS. 30C and 30D show an alternate embodiment plate that may be used in the embodiment shown inFIGS. 30A and 30B ; -
FIG. 31 is a cross-sectional view of two compressible members implanted in intervertebral discs, one of which is another alternate embodiment compressible member. -
FIG. 32 is a cross-sectional view of alternate embodiment compressible member implanted in an intervertebral disc. -
FIGS. 33A and 33B are a top perspective view and a side elevation view (in cross section), respectively, of an endplate and nucleus cutter;FIG. 33C is a side elevation view, in cross section, of an alternative embodiment of the endplate and nucleus cutter. -
FIG. 34A is a side elevation view of a compressor that includes a pair of endplate and nucleus cutters andFIG. 34B is a side elevation view of a distractor that includes an endplate and nucleus cutter. -
FIG. 35 is a schematic view of a compressor with endplate and nucleus cutters inserted into the cavities of adjacent vertebral bodies. -
FIG. 36A is a schematic view of an alternative embodiment of the endplate and nucleus cutter in accordance with the invention;FIG. 36B is a bottom plan view of a main body of the endplate and nucleus cutter ofFIG. 36A ;FIGS. 36C and 36D are a top perspective view and a bottom plan view, respectively, of the cutting surface of the endplate and nucleus cutter ofFIG. 36A ; andFIG. 36E is a perspective view of another alternative embodiment of the endplate and nucleus cutter. - Although the less invasive embodiment shown in
FIG. 7 may not be as effective as the embodiment shown inFIG. 1 and/or may be subject to subsidence, the ability to implant a disc replacement prosthetic device via a hole formed in only one adjacent vertebral body is minimally invasive and is, therefore, advantageous. As a result, the question becomes: how can one replace one or more discs via one vertebral body hole while: (a) greatly reducing the likelihood of subsidence, (b) making the device adaptable to particular patients and/or to the particular disc being replaced; (c) ensuring that the device remains in proper position; (d) providing a straightforward method of implantation; (e) making it cost effective for the patient. - The answer to one or more of the parts to this question lies in the prosthetic device embodiments disclosed herein. These prosthetic device embodiments are not only readily implantable via a hole in a single vertebral body, they are so implantable while: (a) reducing the likelihood subsidence by means of anchors and tabs which serve to fix the device to the cortical bone of the vertebral body; (b) being adaptable by means of various compressible member embodiments; (c) ensuring the device remains in position by being fixedly engaged with the vertebrae and by being encapsulated by the annulus fibrosis; (d) being implantable in a time frame which is no longer than current implantation surgery; and (e) being cost effective by means of being modular and adjustable. The various embodiments of this novel prosthetic device will now be described with reference to the drawings, wherein like numerals indicate like parts.
- A
prosthetic device 200 that minimizes the likelihood that the device may subside in patients with osteopenic bone is shown inFIGS. 15A-15D and 17A-17D. In certain patients having thin bones, the bone (labeled 36, 38 inFIG. 1 , and labeled 88 inFIG. 7 ) in areas adjacent to the implanted prosthetic device may be subject to being crushed and/or collapse under heavy loads. This condition also may occur in other patients after implantation of the prosthetic device, but before the bone graft has time to heal. To minimize subsidence, one or more anchor elements, such as pins, rods, or screws, can be threaded either through a fixation member or through the compressible member to fix the prosthetic device in the hard outer cortical bone of the vertebra in which the cavity was created for device implantation. - The following description of
FIGS. 15A-15D and 17A-17D relates to a prosthetic device embodiment having a compressible member and only one fixation member. However, it should be understood that the features described below can be applied to a prosthetic device having a fixation member on either side of the compressible member (as shown inFIGS. 21A-21D ) or to a prosthetic device having two compressible members on either side of a fixation member (as shown inFIGS. 25-28 ). - The one compressible member/one fixation member embodiment of
FIGS. 15A-15D , 17A-17D is similar to the embodiment ofFIG. 7 . However, whereas theFIG. 7 embodiment provides for a separate second fixation member, the embodiment ofFIGS. 15A-15D , 17A-17D incorporates at least some of the functionality of the second fixation member into the compressible member, amongst other improvements as later described in detail. -
FIGS. 15A-15D and 17A-17D show aprosthetic device 200 having afixation member 214 for fixation within a cavity of a first vertebral body, and acompressible member 218 for implantation in the region of an excavated nucleus pulposus of an operative intervertebral disc. In this embodiment, thefixation member 214 comprises an adjustable member having anouter plate 250 and aninner plate 252. Thecompressible member 218 includes afirst plate 242, asecond plate 244, and one or more compressible elements. In the embodiment shown, the compressible elements are a plurality ofcoil springs 240, positioned between theplates adjustable fixation member 214 and thecompressible member 218 can be secured directly together. That is, aninner plate 252 of thefixation member 214 can include anangled protrusion 253 that mates with anangled recess 243 in thefirst plate 242 of thecompressible member 218 in the manner of a dovetail joint's tenon and mortise. Theangled portions fixation member 214 and thecompressible member 218 together in a keyed fit, without need for other fasteners or fastening materials. It will be understood that, in an alternative embodiment, the angled protrusion can be formed on the first plate of the compressible member, and the angled recess can be formed in the inner plate of the fixation member. - As previously mentioned, the
prosthetic device 200 is designed to minimize subsidence of thedevice 200 into bone adjacent thedevice 200 by employing anchor elements to secure thedevice 200 into hard outer cortical bone. In the illustrated embodiment,plate 244 of thecompressible member 218 includesholes 246 for receipt ofanchor elements 310. A drill guide can be used to create holes through the cortical bone toward theholes 246 in thedevice 200.FIGS. 16A-16D show an embodiment of thedrill guide 300. Thedrill guide 300 includes an L-shapedbody 302 having acurved face 304 at one end and adrill positioning block 306 at the other end. Thedrill positioning block 306 can have one ormore drilling channels 308. Thedrilling channels 308 are configured to guide a drill bit through the bone toward theholes 246 in theplate 244 of thecompressible member 218. - As best seen in
FIG. 15A , thedrill guide 300 can temporarily engageprosthetic device 200 to guide the drilling of holes through bone towardholes 246 inprosthetic device 200. Theguide 300 subsequently facilitates placement of theanchor elements 310 through theholes 246, as best seen inFIG. 17A . To properly position thedrill guide 300 relative toprosthetic device 200, anupper portion 301 of the L-shapedbody 302 is pushed between twoadjustment elements 224 of thefixation member 214 such that thecurved face 304 aligns with and engages athird adjustment element 224 offixation member 214, as shown inFIG. 15A . As theupper portion 301 of the L-shapedbody 302 has a width 303 which is substantially equal to the distance between the twoadjustment elements 224 through which it is pushed, when thecurved face 304 meets thethird adjustment elements 224, the threeadjustment elements 224 substantially immobilize thedrill guide 300 with respect to thedevice 200. - Other embodiments of the drill guide need not include
curved face 304 and can be configured to mount to other portions of the prosthetic device. In addition, the L-shaped body of thedrill guide 300 can be configured to be adjustable along each of the two legs that form the “L”. For example, each leg of the “L” can comprise telescoping elements to lengthen or shorten the leg, depending on the size of the prosthetic device and the position ofholes 246 of thecompressible member 218. Further, as an alternative to mounting thedrill guide 300 to theprosthetic device 200, theguide 300 can be mounted to the outer vertebral body set to receivefixation member 214. In addition, where it is inconvenient or undesirable to use adrill guide 300, another technique, such as fluoroscopic imaging, may be used to determine drill placement. However, such a protocol may be less accurate. - Once holes have been made in the bone,
anchor elements 310 can be inserted throughdrilling channels 308, through the newly-drilled holes in the bone, and through theholes 246 in thecompressible member 218, as shown inFIGS. 17A-17D . Thedrill guide 300 then can be removed from theprosthetic device 200. - The
anchor elements 310 can comprises rods, screws, or any other suitable support structure. In addition, theanchor elements 310 themselves can include small holes or irregularities on their surface, or they may have a bioreactive coating such as hydroxyapatite, to enhance fixation to the bone so that theanchor elements 310 do not back out ofholes 246. - Although the figures show the
anchor elements 310 arranged parallel to each other, holes 246 can be arranged so that theanchor elements 310 diverge or converge. Appropriate holes can be drilled through the cortical bone by reconfiguringdrilling channels 308 in thedrill positioning block 306 to align with the converging/diverging holes in the prosthetic device. Alternatively, thedrill guide 300 may be repositioned after drilling a first hole through the bone that is aligned with a first hole in the prosthetic device, and before drilling a second hole that is aligned with a second hole in the prosthetic device. - In the embodiment of
FIGS. 17A-17D , theanchor elements 310 are dimensioned to traverse the entire diameter of the vertebral body to obtain bi-cortical purchase, that is, fixation in the hard outer cortical bone on either side of the vertebral body. Alternatively, theanchor elements 310 can be shortened so that they to traverse only part of the diameter of the vertebral body to obtain uni-cortical purchase, that is, fixation in the hard outer cortical bone on only one side of the vertebral body. - Further, although the
anchor elements 310 are shown passing through thebottom plate 244 of thecompressible member 218, in alternative embodiments, the site for placement of theanchor elements 310 can be through eitherplate fixation member 214 or through theupper plate 242 of thecompressible member 218. Moreover, as shown inFIGS. 18A-18D , rather than passing through a portion of the prosthetic device, theanchor elements 310 can pass under and adjacent the lowermost plate of the prosthetic device to minimize subsidence of the device into the cancellous subchondral bone in the central portion of the vertebral body. - More specifically,
FIGS. 18A-18D show an embodiment of aprosthetic device 400 having afixation member 414 and acompressible member 418. Thecompressible member 418 has abottom plate 444, here shown with a convexlowermost surface 445. The convexlowermost surface 445 may be configured to sit within a correspondingly shaped concave seat 2050 (shown inFIG. 24 ) formed in the cortical bone of an endplate of an adjacent vertebral body. Theanchor elements 310 are positioned under and just adjacent to thislowermost surface 445 to minimize subsidence of theprosthetic device 400. - In yet another aspect of the present invention, either or both of the plates of the fixation member can include a tab to help minimize subsidence of the prosthetic device.
FIGS. 19A-19E show aplate 500 for a fixation member that includes atab 502 extending from the periphery of the generally circular, main portion of theplate 500. Thetab 502 is configured to rest on outer cortical bone of a vertebral body. In this regard,FIG. 20 is a sectional view through a vertebral body, illustrating aplate 500 with atab 502 extending into outercortical bone 506 of thevertebral body 504. Thetab 502 inhibits the ability of the prosthetic device to sink into thecancellous bone 508 of thevertebral body 504. - The
plate 500 may also include ariser 510 through which holes 511, which are configured to receiveanchor elements 310, can extend. In addition, a drill bit can be guided through theholes 511 in theriser 510 to drill holes through the bone of the vertebral body, thereby eliminating the need fordrill guide 300. Althoughplate 500 is shown inFIGS. 19A-19E and 22 with both atab 502 and ariser 510 withholes 511 foranchor elements 310, it will be understood that other embodiments of the plate can include only a tab, such as inFIG. 22A , or can include holes to receiveanchor elements 310 but lack a tab. - Another
prosthetic device embodiment 700 that incorporates fixation plates likefixation plate 500 in embodiment shown inFIGS. 19A-19E is shown inFIGS. 21A-21D . Thisprosthetic device 700 has first andsecond fixation members compressible member 818. Thefixation members fixation plate 750 on their outer ends; theplates 750 havetabs 751 extending therefrom. When theprosthetic device 700 is implanted in upper and lower vertebral bodies, thetabs 751 rest on the outer cortical bone of the vertebral bodies.Anchor elements 310 may extend through the cortical bone of the vertebral bodies and throughholes 713 formed in thetabs 751, to enhance the stability of theprosthetic device 700. - In yet a further aspect of the present invention, the prosthetic device can include
spacers 620 to maintain thefixation members 714 at a desired elongated position. Thespacers 620 can be used in lieu of the lock screws 63 seen inFIG. 4 and their aforementioned alternatives.FIGS. 23A-23D show an embodiment of aspacer 620 that can be used withfixation members 714. Thespacer 620 has afirst box portion 622, asecond box portion 624, and apeg 626 projecting from thefirst box portion 622. - In a prosthetic device employing a
spacer 620 as shown inFIGS. 21A-21 D, theinner plate 752 of thefixation member 714 can have anotch 754, and eachplate peg 626 of thespacer 620 is configured to pass through thenotch 754 and snap into the well 846, to lock thespacer 620 in place in a snap fit, as shown inFIG. 21A . When thepeg 626 of thespacer 620 is locked in theappropriate plate second box portion 624 resides between theadjustment elements 724 of thefixation member 714, as shown inFIG. 21B . Thespacers 620 may be configured in varying shapes and of various heights to accommodate different sized vertebrae. - The
spacers 620 can be positioned infixation members 714 after thefixation members 714 are properly positioned in the vertebral bodies. That is, once thefixation members 714 are positioned in the vertebral bodies, the tension or load experienced by thecompressible member 818 needs to be adjusted to optimize the normal loading and compression (i.e., the functionality) of the particular disc being replaced. - To optimize the normal loading and compression, a surgeon can use a tensioner, (such as the tensioner described in U.S. Pat. No. 6,761,723) to move the
plates fixation member 714 toward the endplates of the vertebral body. In this manner, the tensioner may be used to elongate thefixation member 714 until a proper elongation distance between theplates fixation member 714 elongates,plate 752 contacts and encounters resistance from thecompressible member 818. The surgeon can continue to apply a load via the tensioner to thefixation member 714 until a desired corresponding reactive load from thecompressible member 818 is reached. - When the applied load measured by the tensioner equals the desired load, the surgeon knows that the
fixation member 714 has been lengthened or elongated an appropriate amount to place thecompressible member 818 under the proper degree of tension. At this point, thespacer 620 can be inserted into thefixation member 714 until thepeg 626 of thespacer 620 snaps in thewell 846. As a result, thespacer 60 maintains thefixation member 714 at the appropriate length. The tensioner then can be removed from thefixation member 714. - As an alternative to the
spacer 620, thestruts 224 can be configured for adjustment like a crutch, that is, by having a hole through an outer casing and a plurality of holes through an adjustable inner member. When the inner member is adjusted to the proper height, a fastener can be inserted through the hole in one side of the casing, through the corresponding hole in the inner member, and then through the hole in the other side of the casing. The fastener immobilizes the inner member with respect to the casing and maintains the proper elongation distance between the upper andlower plates fixation member 214. - Clamps also can be used to maintain the proper elongation distance between the
plates struts 224 to substantially surround thestruts 224 and maintain the proper elongation distance between theplates - A tripod also can be used to maintain the proper distance between the
plates fixation member 214. The surgeon then can position the legs of the tripod on thelower plate 252, preferably against threestruts 224, and position the top of the tripod against theupper plate 250. -
FIGS. 22A-22D show another embodiment of theprosthetic device 700′. Thisprosthetic device 700′ is similar to theprosthetic device 700 ofFIGS. 21A-21D , except that theouter plates 750′ of thefixation members 714′ of thedevice 700′ shown inFIGS. 22A-22D do not include therisers 753 present on theouter plates 750 of thefixation members 714 of thedevice 700 shown inFIGS. 21A-21D . All other elements of thefixation members 714′, 716′ of thedevice 700′ shown inFIGS. 22A-22D are the same as the corresponding elements of thefixation members device 700 shown inFIGS. 21A-21D and, therefore, are similarly numbered but include a differentiating apostrophe. - Another prosthetic device embodiment, which is shown in
FIG. 24 , restores normal biomechanics and motion of a pair of failing, adjacent intervertebral discs. Theprosthetic device 2000 is designed to spare the annulus fibrosis of the discs and the anterior longitudinal ligament of the spine. Moreover, the prosthetic device ensures solid bone fixation via attachment to cancellous vertebral body bone, rather than to the external surface of non-uniform and/or sclerotic vertebral body endplates. - The
prosthetic device 2000 may be implanted and adjusted in a procedure that should not take longer than current spinal fusion procedures. Further, it will be understood from the following description that in conjunction with the previously described embodiments, due to its somewhat modular construction, the prosthetic device can be modified to replace more than two intervertebral discs by including an appropriate number of fixation members and compressible members, as needed. A related embodiment of the invention (later discussed in detail) addresses a method of spinal prosthetic implantation by which one or more intervertebral discs may be replaced by an implantable prosthetic device. - The
prosthetic device 2000 includes first and secondcompressible members 2020 and afixation member 2030 sized to fit within a cavity in thevertebral body 2130 between the firstcompressible member 2020 and the secondcompressible member 2020. The firstcompressible member 2020 is sized to substantially replace the nucleus pulposus of a firstintervertebral disc 2120. Similarly, the secondcompressible member 2020 is sized to substantially replace the nucleus pulposus of a secondintervertebral disc 2140 that is separated from the firstintervertebral disc 2120 by thevertebral body 2130. In the embodiment shown, the secondcompressible member 2020 has the same structure as the firstcompressible member 2020. - Each
compressible member 2020 comprises a compressible body portion formed of one or morecompressible bodies 2022. Thecompressible bodies 2022 may be made of a biocompatible material compressible in an axial direction (i.e., in a direction substantially parallel to the spine). - The
compressible members 2020 include afirst plate 2024 proximal to thefixation member 2030 and asecond plate 2026 distal from the fixation member. Thesecond plates 2026 may havesections 2027 havingconvex surfaces 2028, which may serve as and function like the second fixation member shown inFIG. 7 . Further, as later explained in detail, theconvex surfaces 2028 may be sized to sit within correspondingly shapedconcave seats 2050 formed in the cortical bone endplates of vertebral bodies. - The
fixation member 2030 may include one ormore adjustment members 2038 and/or a locking mechanism, as best shown inFIGS. 26 and 27 . Theadjustment members 2038 may be telescoping struts, the length of which may be fixed by a locking mechanism such as the c-shaped clamps, tripods, spacers, or other suitable extension devices, as previously discussed. By fixing the height of thefixation member 2030, the locking mechanism fixes the load applied to thefixation member 2030. - Similar to the embodiments previously discussed with respect to
FIGS. 15-21 , thefixation member 2030 additionally comprises afirst plate 2032 and asecond plate 2034. The first andsecond plates first plates 2024 of thecompressible members 2020, in a dovetail tenon/mortise relationship. Specifically, as shown inFIGS. 24 and 25 , thefirst plates 2024 haveprojections 2027 which are sized to engage correspondingly shapedslots 2039 formed in the first andsecond plates fixation member 2030. Thefixation member 2030 engages thecompressible members 2020 by sliding theslots 2039 formed in the first andsecond plates fixation member 2030 onto the adjacent correspondingly shapedprojections 2027 formed on thefirst plate 2024 of thecompressible members 2020. - If only one intervertebral disc needs to be replaced, the
second plate 2034 of thefixation device 2030 can rest against an interior side of the subchondral bone of the endplate of a vertebral body adjacent the failing disc. In this instance, thefixation member 2030 would be positioned in a vertebral body adjacent the failing disc and thecompressible member 2020 would be positioned in a failing disc. Thesecond plate 2026 of thecompressible member 2020 may sit within aseat 2050 formed in the cortical bone of the vertebral body above the disc. - Similar to the aforementioned embodiments, to reduce the risk of subsidence, the
compressible members 2020 may includedrilling channels 2029 through thesecond plates 2026. Thedrilling channels 2029 may be configured to receive anchor elements 2160 (e.g., screws, other fasteners, plates, etc.), as shown inFIG. 28 . Theanchor elements 2160 may be journalled through thedrilling channels 2029 and into the cortical bone of a vertebral body, in the manner previously discussed. As a result, the orientation of thecompressible members 2020 with respect to the vertebral body may be additionally stabilized. In addition, either plate of thefixation member 2030 and either plate of thecompressible members 2020 can include a tab, as previously discussed, to help minimize subsidence of the prosthetic device. - To implant the
prosthetic device 2000, a cavity is created in the vertebral body between the two discs to be reconstructed, in the manner previously described. This procedure, which involves excising bone matter from the vertebral body, can be performed using a cutting guide, a chisel and a chisel guide, and a reamer (such as those described in U.S. Pat. No. 6,761,723) and/or using surgical implements discussed herein with respect toFIGS. 33-36 . Bone harvested from the vertebral body by the reamer can be used after implantation of the prosthetic device to promote bone ingrowth into the prosthetic device, as previously described. This procedure creates a cavity bounded by subchondral bone of the endplates of the vertebral body. - Once the cavity in the vertebral body is formed, an endplate and nucleus cutter attached, for example, to a-distractor 920 (shown in
FIG. 34B ), may be used to cut (which may be in the form of boring) through the first endplate of the vertebral body adjacent the first failing intervertebral disc to be replaced. Once through the endplate, the cutting can continue through the nucleus pulposus of the first failing disc to excise the nucleus pulposus thereof, creating a cavity for acompressible member 2020. In this method, the annulus fibrosis is maintained, although it is envisioned that, if the cutting inadvertently cuts into an inner portion of the annulus fibrosis, the annulus fibrosis still may be capable of securely retaining thecompressible member 2020. Additional cutting may be performed into the endplate of the vertebral body on the other side of the first failing intervertebral disc, thereby forming aseat 2050 against which aconvex surface 2028 of thecompressible member 2020 may be positioned. Theseat 2050 will be generally concave in shape so as to better engage theconvex surface 2028 of thecompressible member 2020. - Once the nucleus pulposus of the first failing intervertebral disc has been excised and the
seat 2050 has been formed, the same process may be used to bore through the other endplate of the vertebral body in which the cavity was formed and through the nucleus pulposus of the second failing disc adjacent it. Further, aseat 2050 may be formed in the vertebral body on the other side of the second failing disc. - Once cutting is completed, a first
compressible member 2020 is positioned in the cavity in the vertebral body and then pushed through the hole in the endplate and into the space left by the excised nucleus of the first failing disc. - As the first
compressible member 2020 is inserted into the first failing disc, theconvex surface 2028 is pushed into theseat 2050 in the vertebral body endplate on the other side of the disc. Although theconvex surface 2028 may be positioned in cancellous bone in the interior of a vertebral body, it is preferably position in the cortical bone, to help minimize the risk that thesecond plate 2026 will, over time, undesirably creep into the vertebral body as a result of loading. - Once the first
compressible member 2020 is fully implanted, a secondcompressible member 2020 is inserted into the second failing intervertebral disc in the same manner. Similarly, theconvex surface 2028 of the secondcompressible member 2020 is inserted into theseat 2050 adjacent the second failing disc. It should be readily recognized that the order in which thecompressible members 2020 are inserted can be reversed. - Once the
compressible members 2020 are in place, the surgeon slides afixation member 2030 into the cavity in the vertebral body while engaging theprojections 2027 of thecompressible members 2020 and theslots 2039 in the first andsecond plates fixation member 2030. As a result, thefixation member 2030 is fixedly joined to thecompressible members 2020. In other embodiments, thecompressible members 2020 and thefixation member 2030 may be connected by conventional attachment members, such as screws, or by biocompatible cement or a suitable adhesive composition. - When the
fixation member 2030 is in place, the length of theadjustment members 2038 can be adjusted to fix the length of thefixation member 2030, in the manner previously described. Similarly, the length of thefixation member 2030 can be maintained by using a locking mechanism, such asspacer 2036, which prevents further inward adjustment of theadjustment members 2038, as previously described. Alternatively, fixation members can be available in a variety of fixed sizes; a properly sized fixation member could be selected for implantation in the cavity of the vertebral body, thereby negating the need for a locking mechanism. Regardless, when the length of thefixation member 2030 is fixed, the cavity in the vertebral body may be filled with bone graft, as previously described. - To reduce the risk of subsidence, the
compressible members 2020 and/or thefixation member 2030 may havedrilling channels 2029 for receiving anchor elements 2160 (e.g., screws) to supplement immediate fixation during healing of the bone graft, as previously described. - A porous bone ingrowth coating and/or surface texturing may also be applied to the device. For example, hydroxyapatite or other bone-to-implant chemical or biological interface surface treatment may be applied to the first and
second plates fixation member 2030 and/or to the convex surfaces 2028 (each of which is in contact with bone), to enhance bone growth into a textured porous surface. - If either of the vertebral bodies adjacent the
compressible members 20 are scoliotic, thecompressible elements 2022 used in thecompressible members 2020 may be designed to combat this problem. Specifically, the selectedcompressible elements 2022 may have spring constants which are greater or less than the spring constants of the remainingcompressible elements 2022. As a result, corrective loading on the scoliotic bodies can be better achieved. - Unlike conventional implanted prosthetic devices, which are typically not recommended for replacing two discs, this
prosthetic device embodiment 2000 easily replaces the nucleus pulposuses of the intervertebral discs both above and below a vertebral body. Further, not only is this approach more efficient for surgeons, it avoids the problems inherent in separately distracting two disc spaces sufficiently to insert total disc replacements. - Various intervertebral disc prosthetic device embodiments (and the methods of implanting them) have been described. In conjunction with these embodiments, however, various modifications may be used to address a particular patient's condition and/or the level in the spine in which the device will be implanted (e.g., between Lumbar-5 and Sacrum-1 there is a great variation among patients in the shape of the joint). Accordingly, the following describes various alternative compressible member embodiments which may be employed with any of the aforementioned prosthetic device embodiments.
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FIGS. 29A-29E show two alternate embodiments for a compressible member. Specifically,FIGS. 29A and 29B respectively show a cross-sectional view and a perspective view of acompressible member 2100 andFIG. 29E shows thecompressible member 2100 positioned in a disc. - The
compressible member 2100 is formed of abase member 2102 that may, as shown, be in the shape of a cup. Thelower surface 2112 of thebase member 2102 may be attached to a fixation member (not shown inFIGS. 29A-29E ) in any manner previously discussed (e.g., screws, dovetail tenon/mortise joint, etc.) - A
circumferential wall 2114 of thebase member 2102, which rises upward from thelower surface 2112, encloses a plurality of compressible elements 2104 (e.g., springs, or any other compressible element previously discussed). As shown inFIG. 29E , thewall 2114, when implanted, compensates for anatomic variations and assures that theendplate 2122 of thevertebral body 2120 engages solid metal. - The other ends of the
compressible elements 2104 are attached to anupper member 2106, in a manner similar to the previously described compressible member embodiments. Similarly, theupper member 2106 may have aconvex surface 2108 which is configured to rest within a seat 2050 (shown inFIG. 24 ) formed in a vertebral body endplate, as previously discussed. - The
compressible member embodiment 2100′ shown inFIGS. 29C-29D is substantially similar to thecompressible member embodiment 2100 shown inFIGS. 29A-29B , except that thewall 2114 in thebase member 2102 in the embodiment shown inFIGS. 29A-29B is replaced with a slottedwall 2114′ defining analternative base member 2102′. - The reason for the slotted
wall 2114′ is that for some individuals and/or some disc locations, additional clearance may serve to facilitate placing the springs over as wide an area as possible. However, as the slots reduce the support and attachment to the cortical bone of the vertebral body, the desires to use certain spring designs and to enhance support/attachment must be weighed in each particular instance. - Another
compressible member 2200 embodiment is shown inFIGS. 30A-30B . Thecompressible member 2200 includes abase member 2202,compressible elements 2204, and anupper member 2206. In this embodiment, thebase member 2202 is wider than the diameter of thehole 2210 but narrow enough so that it can go through thehole 2210 at an angle after which it can be maneuvered so as to cover thehole 2210, as shown inFIG. 30B . In either case, thebase member 2202 rests against the cortical bone of thevertebral body 2220, thereby reducing the likelihood that thecompressible member 2200 may experience subsidence into thevertebral body 2220 as a result of cyclical loads applied to thecompressible member 2200. - Another
compressible member 2200′ embodiment is shown inFIGS. 30C and 30D . In this embodiment, thebase member 2202′ is expandable to be wider than the diameter of thehole 2210 in a vertebral body endplate through which thecompressible member 2200′ is implanted. Specifically, thebase member 2202′ includes arotatable driving plate 2240 and a plurality of radiallyadjustable leaves 2250. The rotatable plate includes a plurality ofprojections 2242 that, when therotatable plate 2240 rotates, push theleaves 2250 radially outward alongrails 2260, thereby radially adjusting the overall diameter of thebase member 2202′. As a result, after thecompressible member 2200′ is pushed through thehole 2210, thebase member 2202′ may be radially expanded to fix thebase member 2202′ in a manner similar to that shown inFIG. 30B . In addition, although the size ofbase member 2202′ is described as being adjusted by means of leaves, the embodiment is not so limited. Rather, the base member could be adjusted in other ways such as, for example, by means of screws, telescoping rods, etc. - Another
compressible member 2400 embodiment is shown inFIG. 31 . A firstcompressible member 2300, which is provided in a first disc, abuts (along a concave seat 2050) a firstvertebral body 2430 and is connected to afixation member 2440. This firstcompressible member 2300 and thefixation member 2440 may be any of the compressible member embodiments and fixation member embodiments, respectively, previously discussed. However, it is a secondcompressible member 2400, which is also connected to thefixation member 2440, which is the focus ofFIG. 31 . Moreover, although the secondcompressible member 2400 is shown as being part of a dual compressible member device, it should readily be recognized that it could be incorporated in a single compressible member device. - The second
compressible member 2400, like previous embodiments, includes abase member 2402 supporting a plurality ofcompressible elements 2404. The other ends of thecompressible elements 2404 are connected to anotherplate 2406. Whereas in previous embodiments, theplate 2406 would rest against a vertebral body, in this embodiment, theplate 2406 is attached to a ball-and-socket joint comprised of asocket 2408 and aball 2410. Thesocket 2408 is attached to theplate 2406 and theball 2410 is immobilized in thevertebral body 2460 by means of aspike 2412 or screw. - The purpose of the ball-and-socket connection is to accommodate anatomic variation in which the angle between vertebral endplates may be highly variable among patients. This is particularly helpful between Lumbar-5 and Sacrum-1 where there is a great variation among patients in the shape of the joint and where replacement of two discs (as shown in
FIG. 31 ) in this area is particularly complicated. - It should be readily recognized that the
compressible member embodiments FIG. 31 can be switched. In other words, thecompressible member embodiment 2300 currently adjacent the uppervertebral body 2430 can be switched with thecompressible member embodiment 2400 currently adjacent the lowervertebral body 2460. -
FIG. 32 shows another embodiment of acompressible member 2500, which like theembodiment 2400 shown inFIG. 31 employs aspike 2512 to immobilize aplate 2506, as hereafter explained in detail. Thecompressible member embodiment 2500, like previous embodiments, has abase member 2502, anupper member 2506, and a plurality ofcompressible elements 2504 which extend between thebase member 2502 and theupper member 2506. - Whereas in many of the previously described embodiments, the end of a compressible member away from a fixation member was formed to have a convex surface configured to engage a
concave seat 2050 formed in a vertebral body, in some instances such an engagement may not provide adequate support for the compressible member. As a result, in thecompressible member embodiment 2500 shown inFIG. 32 , theplate 2506 adjacent thevertebral body 2520 is formed with aspike 2512 that is configured to penetrate into thevertebral body 2520 so as to immobilize theplate 2506 with respect to thevertebral body 2520. Moreover, the likelihood of subsidence of thecompressible member 2500 into thevertebral body 2520 is slight as a result of the remainder of theplate 2506 abutting the cortical bone endplate of thevertebral body 2520. - The aforementioned described various implantable prosthetic devices and the methods by which they may be implanted. In conjunction with these devices and their methods of implantation, this invention also addresses various tools by which the implantation methods may be performed.
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FIGS. 33A-33C illustrate a surgical implement, that is, a cutting implement that can be mounted to a compressor 900 (shown inFIG. 34A ) or a distractor 910 (shown inFIG. 34B ) to cut through an endplate of a vertebral body and the nucleus pulposus of the intervertebral disc adjacent the vertebral body. The exemplary cutting implement is in the form of an endplate andnucleus cutter 920 having a substantiallycircular sidewall 921 that terminates in acutting edge 922. - The maximum diameter of the
sidewall 921 of the endplate andnucleus cutter 920 should not be greater than the minimum diameter of the nucleus pulposus and/or the diameter of the prosthesis to be implanted. In addition, thecutting edge 922 can be smooth or, alternatively, serrated. Thecutting edge 922 may be thinner than thesidewall 921 and may be tapered to a sharp end. The endplate andnucleus cutter 920 optionally can have aprojection 923, as shown inFIG. 33B . The tip of theprojection 923 can be used to create a notch in an endplate, thereby bracing the endplate andnucleus cutter 920 relative to the endplate; theprojection 923 can serve as an axis of rotation. Moreover, this bracing effect enables a surgeon to cut through the endplate with the sharp end of the endplate andnucleus cutter 920, without risk that the endplate andnucleus cutter 920 will inadvertently slide from its proper position relative to the endplate surface. - An alternative embodiment of the endplate and
nucleus cutter 920′ is shown inFIG. 33C . The only difference between this embodiment and the one shown inFIG. 33B is that theprojection 923′ is cylindrical in shape and has a concave end. An advantage of employing the embodiment ofFIG. 33C with the embodiment ofFIG. 33B on asingle compressor 900 is that when the sharp edges of the two endplate andnucleus cutters 920 approach each other, the tip of theprojection 923 on thefirst cutter 920 will be partially journalled into the concave end portion of theprojection 923′ of thesecond cutter 920′. - As shown in
FIG. 34A , an endplate andnucleus cutter 920 can be attached to anend portion 901 of afirst arm 902 of thecompressor 900 to face asecond arm 904. Similarly, an endplate andnucleus cutter 920, which is attached to anend portion 903 of thesecond arm 904, faces toward thefirst arm 902 and toward the other endplate andnucleus cutter 920. - When the
handle 905 of thecompressor 900 is compressed, the first andsecond arms second arms nucleus cutters 920 approach each other. The endplate andnucleus cutters 920 on the first andsecond arms handle 905 is fully compressed, the cuttingedges 922 of the endplate andnucleus cutters 920 contact each other. - The endplate and
nucleus cutters 920 can be either fixedly mounted or rotatably mounted to thearms compressor 900. When the endplate andnucleus cutters 920 are fixedly mounted, the surgeon can manually rotate thecutters 920 by swinging thehandle 905 of thecompressor 900 side-to-side. This side-to-side motion, combined with compression of thehandle 905, enables the cuttingedges 922 to cut through the endplate and nucleus pulposus of the damaged disc. Alternatively, the endplate andnucleus cutters 920 may be rotatably mounted to thecompressor 900. A motor or other drive source can be connected to thecutters 920 to rotate them relative to thearms compressor 900. - The
compressor 900 can be used when a surgeon wants to implant a prosthetic device having two fixation members, one of which is to go into a vertebral body above a problematic disc and the other of which is to go into the vertebral body below the problematic disc.FIG. 35 shows acompressor 900 being inserted into adjacent vertebral bodies to remove the nucleus pulposus of a damaged disc. - In some situations, however, the surgeon needs to implant only one fixation member (e.g., the embodiments shown in
FIGS. 15-18 and 24-28) or only one non-extendable fixation member coupled to a compressible member (e.g., the embodiment shown inFIG. 7 ). In such situations, adistractor 910 with only one, outwardly facing endplate andnucleus cutter 920 may be used. -
FIG. 34B shows adistractor 910 having one endplate andnucleus cutter 920 on afirst arm 912 which faces outward and away from asecond arm 914. An outwardly facingplate 930 is rotatably attached to thesecond arm 914 by anaxle 931. Theplate 930 is designed to be placed against an endplate in a vertebral body and to remain immobile relative to the vertebral body. - As the endplate and
nucleus cutter 920 of thedistractor 910 either is manually rotated by the surgeon (in an embodiment where the endplate andnucleus cutter 920 is fixedly mounted to the distractor 500) or rotates as a result of a motor (in an embodiment where the endplate andnucleus cutter 920 is rotatably mounted to the distractor 910), the endplate andnucleus cutter 920 will cut through one endplate in a vertebral body, while theplate 930 remains pressed against the other endplate in the vertebral body. Theplate 930 will not abrade the vertebral body against which it is placed because it does not rotate with respect to that endplate. - When the
arms distractor 910 are inserted into a cavity in a vertebral body and thehandle 915 is subsequently compressed, theplate 930 will move in one direction to contact the endplate of the vertebral body, and the endplate andnucleus cutter 920 will move in an opposite direction to contact the other endplate of the vertebral body. Continued compression of thehandle 915 and rotation of the endplate andnucleus cutter 920 will force thecutter 920 through the endplate and the nucleus pulposus of the adjacent intervertebral disc. - It will be understood that an endplate and
nucleus cutter 920 can be mounted to devices having a configuration different than thecompressor 900 anddistractor 910. For example, an endplate andnucleus cutter 920 can be attached to an end of a single arm, and a surgeon can grip the opposite end of the single arm to position the endplate andnucleus cutter 920 appropriately to cut through the endplate and the nucleus pulposus of a damaged disc. The single arm can be bent to provide additional leverage. -
FIGS. 36A-36D illustrate another embodiment of an endplate andnucleus cutter 1000. Thiscutter 1000 includes arotating axle 1002 withmultiple arms 1004, a cylindricalmain body 1006 with a pair ofoblique slots 1008 to receive thearms 1004 of theaxle 1002, and acutting surface 1010 that attaches to the cylindricalmain body 1006. Thecutting surface 1010 can have a flat profile or it can have a convex, domed profile as seen inFIGS. 36A, 36C , and 36D. Thecutting surface 1010 includes cuttingedges 1012 that enable thecutter 1000, when rotated, to cut through the endplate and the nucleus pulposus of the disc. - In another embodiment shown in
FIG. 36E , aserrated cutting edge 1010′ can be defined around a perimeter of a cup-shapedcutter 1000′ which is similar in shaped to the endplate andnucleus cutter 920 shown inFIGS. 33A and 33B . - The
cutter 1000 can be mounted to the arm of a compressor or a distractor and, once positioned at a cutting location in a vertebral body, can elongate and move away from the arm. Accordingly, thecutter 1000 can be placed through a relatively small vertebral body window and still reach all the way through the vertebral body endplate and the nucleus pulposus of the damaged disc. When thecutter 1000 is in the shortened position, thearms 1004 of theaxle 1002 are positioned in theslots 1008 at a location close to thecutting surface 1010. With rotation of theaxle 1002, friction forces thearms 1004 to slide up theslots 1008, which in turn elongates thecutter 1000 and moves thecutting surface 1010 toward the area to be cut. - The intervertebral prosthetic device embodiments of the present invention offer several advantages. For example, the intervertebral prosthetic device embodiments replicate the mechanical properties of a natural intervertebral disc. The intervertebral prosthetic device embodiments restore disc height, defined as the axial distance between vertebrae adjacent the damaged disc, and duplicate the range of motion of a natural intervertebral joint.
- As the prosthetic device embodiments have no ball bearings (with the exception of the ball-and-socket joint of the embodiments shown in
FIG. 31 ), rollers, or hinges, the intervertebral prosthetic device embodiments suffer minimal degradation of the prosthetic material and produce minimal wear debris under long-term cyclic loading conditions. Further, the prosthetic device embodiments: (a) can axially compress and thus dissipate energy; (b) may be easily repaired or replaced; (c) may be easily manufactured and implanted by a surgeon; and (d) are durable and modular. Moreover, as the prosthetic device embodiments need not include plastic polymers or elastomeric components, the prosthetic device embodiments do not degrade under long-term cyclic loading conditions. - It should be understood that the benefit of the implantation procedure for the one compressible member/one fixation member embodiment and the dual compressible member/one fixation member embodiments is that only one vertebral body cavity is formed. As a result, both the time necessary for the implantation procedure and the amount of resultant healing are greatly reduced.
- Although the previously described embodiments of the intervertebral prosthetic device include an adjustable fixation member, it will be understood that the intervertebral prosthetic device can include a rigid fixation member sized specifically to fit the vertebral body and to adequately pretension the compressible member. Rigid fixation members can be made in various sizes so that a surgeon can select an appropriately sized fixation member for the particular surgical site.
- The prosthetic device embodiments can comprise biocompatible metallic materials, such as a titanium alloy having, for example, 4% vanadium and 6% aluminum. Persons of skill in the art will recognize other suitable materials, for example, a cobalt-chromium alloy, such as
alloy number 301. Alternatively, the prosthetic device embodiments, with the exception of the springs of the compressible member, can comprise a ceramic material, such as aluminum oxide or zirconium oxide. The porous surfaces of the fixation members can be coated with hydroxyapatite or bioactive proteins (e.g., bone morphogenic protein) to encourage bone ingrowth. - The fixation members of the prosthetic device embodiments, which may be composed of carbon fiber polyetheretherketone, bone graft (auto- or allo-graft bone), bone cement, etc., support the compressible member(s) until the bone graft (which is packed into the open space of the fixation members) heals. Once the bone graft heals, however, the fixation members may no longer be needed. Accordingly, the fixation members of the prosthetic device embodiments may be composed of a bioresorbable material that would gradually be replaced by bone over time. Suitable bioresorbable materials to form the fixation members include structural allograft (bank) bone, or polymers made of polylactic acid or polyglycolic acid. Similarly, the anchor members also can be made of carbon fiber or of a bioresorbable material, such as polylactic acid, polyglycolic acid, or a combination of those materials.
- The compressible members may be, for example, springs, elastomers, monolithic bodies, elastic polymers, hydrogels, disc allograft, or any other material which displays similar mechanical properties when placed under stress (i.e., tension and/or compression) and which substantially regains its original shape upon removal of the stress.
- The embodiments of the prosthetic device previously described have advantages over conventional devices. For example, although the prosthetic device may be implanted using a straight anterior approach, it may be implanted using an anterolateral approach to the spine that is a retroperitoneal approach in the plane between the abdominal vessels and the psoas muscle.
- Unlike the conventional and more dangerous straight anterior approach required by total disc replacement devices (which sever the anterior longitudinal ligament and/or sever the annulus fibrosis, both of which disrupt tissues that will not heal), the embodiments described herein only disrupt bone material in the adjacent vertebral body and the nucleus pulposus in the intervertebral disc. The bone heals and the nucleus pulposus is replaced by the prosthetic device.
- Further, the embodiments of the prosthetic device described herein minimally infringe upon areas of the vertebral body which would be used to provide a fusion should that later become necessary. Specifically, by maintaining the anterior longitudinal ligament, the anterolateral approach helps maintain spinal function and stability. In addition, an anterolateral approach on one side of a vertebral body allows for a later opposite side approach for adjustment of the device or for adjacent level disc replacement should that become necessary. Further, this opposite side approach would not be hindered by scar tissue from the previous procedure.
- The prosthetic device embodiments also allow for bending and torsion motion, as well as axial displacement and elastic compression. Further, unlike an articulated joint, the prosthetic device deforms similarly to a normal, healthy disc. Moreover, unlike previous total disc replacement devices which may result in motion of about 3.8° to 4.6°, the embodiments of the invention herein described maintain the motion at a nearly healthy level of motion, i.e., about 7° to about 12°.
- The ability to pretension the fixation member allows for a more precise restoration of disc height. Further, as the fixation members may be anchored entirely to cancellous bone, at least some embodiments avoid problems inherent to poor bony ingrowth, which may result from sclerotic endplates. As a result, the risk of device loosening is minimized. And, as the device is enclosed entirely by bone and the annulus fibrosis, ejection, dislocation, and migration of the device is very unlikely. In addition, intramedullary fixation of the fixation member in the vertebral body provides greater stability. The fixation member is provided within the cancellous bone of a vertebral body adjacent the failing disc(s), to maximize the osteogenic potential of bone to grow into the fixation member. Further, the replacement of the autologous bone removed from the vertebral body during the procedure (or the addition of bone cement) into the open vertebral body facilitates the transfer of loads to the cortical bone walls of the vertebral body once the bone heals.
- Moreover, fibrous soft tissue growth into the compressible members will fill the normal volume of the disc nucleus. As a result, as the compressible member is compressed, this tissue will bulge outward and radially load the inner annulus fibrosis in a manner similar to a healthy nucleus. The radially outward loading will restore the function of the retained annulus fibrosis.
- Finally, the prosthetic device embodiments may be used no matter how collapsed a patient's disc may be. An overdistraction problem inherent for installation of total disc replacements does not arise with respect to the prosthetic device described herein.
- The preferred embodiments have been set forth herein for the purpose of illustration. This description, however, should not be deemed to be a limitation on the scope of the invention. Additional advantages and modifications will readily occur to those skilled in the art. Therefore, the invention in its broader aspects is not limited to the specific details, and representative devices, shown and described herein. Accordingly, various modifications may be made without departing from the spirit or scope of the general inventive concept as defined by the appended claims and their equivalents.
Claims (57)
1. A prosthetic device comprising:
a first compressible member sized to substantially replace the nucleus pulposus of a first intervertebral disc;
a second compressible member sized to substantially replace the nucleus pulposus of a second intervertebral disc that is separated from the first intervertebral disc by a vertebral body; and
a fixation member sized to fit within a cavity in the vertebral body between the first and second compressible members.
2. The prosthetic device according to claim 1 , wherein the fixation member comprises:
at least one adjustable member configured to adjust a length of the fixation member; and
a locking mechanism configured to maintain the adjustable member at a fixed length.
3. The prosthetic device according to claim 2 , wherein the locking mechanism is a spacer.
4. The prosthetic device according to claim 1 , wherein each of the first and second compressible members comprises at least one of a spring, an elastomer, and disc allograft.
5. The prosthetic device according to claim 1 , wherein a plate of each of the first and second compressible members is configured to be positioned within a seat formed in an endplate of the vertebral body adjacent thereto.
6. A prosthetic device comprising:
a fixation member sized to fit within a cavity in a first vertebral body; and
a compressible member sized to substantially replace a nucleus pulposus of an intervertebral disc adjacent the vertebral body,
wherein:
(A) a first side of the compressible member is configured to engage the fixation member and a second side of the compressible member is configured to engage a second vertebral body, and
(B) the second side of the compressible member is configured to fit within a seat formed in the cortical bone of the endplate of the second vertebral body.
7. An intervertebral prosthetic device for implantation in a spine, comprising:
a rigid fixation member having a fixed length, the rigid fixation member being configured to be placed in a cavity of a vertebral body and against bone of the vertebral body; and
a first compressible member configured to be placed in a cavity in a first intervertebral disc adjacent the vertebral body and to be secured to the rigid fixation member,
wherein:
(A) the compressible member is constructed to remain compressible after implantation and has at least one compressible element that remains compressible after implantation, and
(B) the rigid fixation member is sized to compress the compressible member a predetermined amount when the rigid fixation member and the first compressible member are placed in the cavity in the first vertebral body and in the cavity in the first intervertebral disc, respectively.
8. The intervertebral prosthetic device according to claim 7 , further comprising:
a second compressible member,
wherein the second compressible member is configured to be:
(A) placed in a cavity in a second intervertebral disc adjacent the vertebral body on the opposite side as the first intervertebral disc; and
(B) secured to the rigid fixation member.
9. The intervertebral prosthetic device according to claim 8 , wherein the first and second compressible members are sized to replace the nucleus pulposuses of the first and second intervertebral discs, respectively.
10. The intervertebral prosthetic device according to claim 7 , wherein the rigid fixation member is composed of a bioresorbable material.
11. The intervertebral prosthetic device according to claim 7 , wherein the first compressible member has a plate opposite the rigid fixation member having a convex outer surface.
12. The intervertebral prosthetic device according to claim 11 , wherein the convex lowermost surface is configured to rest within a corresponding concave indentation formed in a second vertebral body adjacent thereto.
13. An intervertebral prosthetic device for implantation in a spine comprising:
a fixation member configured to be placed in a cavity of a vertebral body, the fixation member comprising:
an outer member configured to be placed against bone of the vertebral body;
an inner member opposite the outer member; and
at least one adjustment element that extends between the outer and inner members and that is configured to adjust a length dimension of the fixation member along its longitudinal axis;
a compressible member configured to be placed in a cavity in an intervertebral disc adjacent the vertebral body and configured to be secured to the inner member of the fixation member; and
a spacer sized to fit between the outer and inner members of the fixation member to maintain the fixation member at a desired length dimension.
14. The intervertebral prosthetic device according to claim 13 , wherein the outer and inner members of the fixation member comprise outer and inner plates, respectively.
15. The intervertebral prosthetic device according to claim 14 , wherein the inner plate of the fixation member includes a notch through which a portion of the spacer extends.
16. The intervertebral prosthetic device according to claim 15 , wherein the portion comprises a peg.
17. The intervertebral prosthetic device according to claim 13 , wherein the spacer includes a peg.
18. The intervertebral prosthetic device according to claim 17 , wherein the compressible member includes a well dimensioned to receive the peg in a snap fit.
19. The intervertebral prosthetic device according to claim 13 , wherein the compressible member has a bottom plate with a convex lowermost surface.
20. The intervertebral prosthetic device according to claim 19 , wherein the convex lowermost surface is configured to rest within a corresponding concave indentation formed in a second vertebral body adjacent thereto.
21. An intervertebral prosthetic device for implantation in a spine, comprising:
a fixation member configured to be placed in a cavity of a vertebral body, the fixation member comprising:
an outer member configured to be placed against bone of the vertebral body;
an inner member opposite the outer member; and
a longitudinal axis extending between the outer and inner members; and
a compressible member configured to be placed in a cavity in an intervertebral disc and to be secured to the inner member of the fixation member,
wherein:
(A) the compressible member is constructed to remain compressible after implantation, and
(B) the outer member includes a tab extending outward along an axis different from the longitudinal axis.
22. The intervertebral prosthetic device according to claim 21 , wherein the outer and inner members of the fixation member comprise outer and inner plates, respectively.
23. The intervertebral prosthetic device according to claim 21 , wherein the compressible member has a bottom plate with a convex lowermost surface.
24. The intervertebral prosthetic device according to claim 23 , wherein the convex lowermost surface is configured to rest within a corresponding concave indentation formed in a second vertebral body adjacent thereto.
25. An intervertebral prosthetic device for implantation in a spine, comprising:
a fixation member configured to be placed in a cavity of a vertebral body, the fixation member comprising:
an outer member configured to be placed against bone of the vertebral body;
an inner member opposite the outer member; and
a longitudinal axis extending between the outer and inner members;
a compressible member configured to be placed in a cavity in an intervertebral disc adjacent the vertebral body and configured to be secured to the fixation member; and
at least one anchor element configured to immobilize and/or stabilize the compressible member and/or the fixation member.
26. The intervertebral prosthetic device according to claim 25 , wherein compressible member is constructed to remain compressible after implantation and has at least one compressible element that remains compressible after implantation.
27. The intervertebral prosthetic device according to claim 25 , wherein the anchor element is dimensioned to extend into at least one of the fixation member and the compressible member and through bone adjacent to at least one of the fixation member and the compressible member.
28. An intervertebral prosthetic device according to claim 25 , wherein the anchor element extends through bone adjacent the outer member of the fixation member and into the outer member.
29. The intervertebral prosthetic device according to claim 25 , wherein the compressible member has a bottom plate with a convex lowermost surface.
30. The intervertebral prosthetic device according to claim 29 , wherein the convex lowermost surface is configured to rest within a corresponding concave indentation formed in a second vertebral body adjacent thereto.
31. A prosthetic device comprising:
a fixation member sized to fit within a cavity in a first vertebral body; and
a compressible member comprising:
a cup-shaped base member;
an upper member; and
one or more compressible elements provided between the base member and the upper member,
wherein the compressible member is sized to substantially replace a nucleus pulposus of an intervertebral disc adjacent the vertebral body.
32. The prosthetic device according to claim 31 , wherein the base member of the compressible member is configured to engage the fixation member and the upper member of the compressible member is configured to engage a second vertebral body.
33. The prosthetic device according to claim 31 , wherein the cup-shaped base member has a wall, and wherein one or more slots are provided in the wall.
34. A prosthetic device comprising:
a fixation member sized to fit within a cavity in a first vertebral body; and
a compressible member comprising:
a base member;
an upper member that includes a spike; and
one or more compressible elements provided between the base member and the upper member,
wherein the one or more compressible elements are sized to substantially replace a nucleus pulposus of an intervertebral disc adjacent the vertebral body.
35. The prosthetic device according to claim 34 , wherein the base member of the compressible member is configured to engage the fixation member and the upper member of the compressible member is configured to engage a second vertebral body.
36. A prosthetic device comprising:
a fixation member sized to fit within a cavity in a first vertebral body; and
a compressible member comprising:
a base member;
an upper member comprising a ball-and-socket joint; and
one or more compressible elements provided between the base member and the upper member,
wherein the compressible member is sized to substantially replace a nucleus pulposus of an intervertebral disc adjacent the vertebral body.
37. The prosthetic device according to claim 36 , wherein the upper member further comprises a plate supporting the ball-and-socket joint, and wherein the ball-and-socket joint comprises a spike.
38. The prosthetic device according to claim 36 , wherein:
(i) the base member of the compressible member is configured to engage the fixation member, and
(ii) the upper member of the compressible member is configured to engage a second vertebral body.
39. The prosthetic device according to claim 36 , wherein the ball-and-socket joint is configured to be fixed or to remain mobile upon implantation.
40. A prosthetic device comprising:
a fixation member sized to fit within a cavity in a first vertebral body; and
a compressible member comprising:
a base member;
an upper member; and
one or more compressible elements provided between the base member and the upper member,
wherein:
(A) the compressible member is sized to substantially replace a nucleus pulposus of an intervertebral disc adjacent the vertebral body, and
(B) the base member is adjustable in a radial direction.
41. The prosthetic device according to claim 40 , wherein the base member is adjustable by means of a rotatable plate having a plurality of projections.
42. The prosthetic device according to claim 41 , wherein when the rotatable plate rotates, the projections engage and radially extend a plurality of extendable leaves.
43. A method of spinal prosthetic implantation, the method comprising the step of:
creating a cavity in a first vertebral body;
cutting a first hole through either a lower or an upper endplate of the vertebral body and through the nucleus pulposus of a first intervertebral disc adjacent thereto, thereby creating a first opening in the first intervertebral disc;
cutting a second hole through the other of the lower and upper endplate of the vertebral body and through the nucleus pulposus of a second intervertebral disc adjacent thereto, thereby creating a second opening in the second intervertebral disc;
implanting a first compressible member into one of the first and second openings;
implanting a second compressible member into the other of the first or second openings; and
implanting a fixation member into the cavity in the first vertebral body.
44. The method according to claim 43 , further comprising the step of adjusting a length of the fixation member.
45. The method according to claim 43 , further comprising the step of creating a first seat in an endplate of a second vertebral body below the first vertebral body.
46. The method according to claim 45 , further comprising the step of creating a second seat in an endplate of a third vertebral body above the first vertebral body, wherein each of the first and second seats is configured to receive a respective one of the first and second compressible members.
47. The method according to claim 43 , further comprising the step of positioning, in the fixation member, at least one of bone allograft, bone cement, and a bioresorbable polymer.
48. The method according to claim 43 , wherein the step of implanting a first compressible member into one of the first and second opening comprises providing a plurality of compressible elements in the first compressible member, wherein the plurality of compressible elements vary in a degree to which they are compressible.
49. The method according to claim 43 , wherein:
(i) the first compressible member comprises a base member that is wider than the hole cut in the vertebral body through which the first compressible member is implanted, and
(ii) the step of implanting the first compressible member into one of the first and second openings comprises the steps of: (a) maneuvering the base member of the first compressible member so that it passes through the hole in the one of the first and second openings; and (b) rotating the base member so that it substantially covers the hole.
50. The method according to claim 43 , wherein:
(i) the first compressible member comprises a base member that is radially adjustable to be wider than the hole cut in the vertebral body through which the first compressible member is implanted, and
(ii) the step of implanting the first compressible member into one of the first and second openings comprises the steps of: (a) maneuvering the base member of the first compressible member so that it passes through the hole in the one of the first and second openings; and (b) radially expanding the base member so that it substantially covers the hole.
51. A method of spinal prosthetic implantation, the method comprising the steps of:
creating a cavity in a first vertebral body;
cutting through an endplate of the vertebral body and through the nucleus pulposus of an adjacent intervertebral disc, thereby creating an opening in the intervertebral disc;
cutting into the cortical bone of a second vertebral body on the other side of the intervertebral disc to create a seat;
implanting a compressible member into the opening in the intervertebral disc such that a distal end of the compressible member sits within the seat in the second vertebral body; and
implanting a fixation member in the cavity in the first vertebral body.
52. The method according to claim 51 , further comprising the step of adjusting a length of the fixation member.
53. A method of spinal prosthetic implantation, the method comprising the step of:
creating a cavity in a vertebral body;
cutting a hole through either a lower or an upper endplate of the vertebral body and through the nucleus pulposus of an intervertebral disc adjacent thereto, thereby creating an opening in the intervertebral disc;
implanting a compressible member into the opening in the intervertebral disc; and
implanting a fixation member into the cavity in the first vertebral body,
wherein:
(i) the compressible member comprises a base member that is wider than the hole cut in the vertebral body through which the first compressible member is implanted, and
(ii) the step of implanting the compressible member into the opening comprises the steps of: (a) maneuvering the base member of the compressible member so that it passes through the hole and into the opening; and (b) rotating the base member so that it substantially covers the hole.
54. The method according to claim 53 , further comprising the step of creating a seat in an endplate of a second vertebral body on the other side of the intervertebral disc in which the opening is formed.
55. A method of spinal prosthetic implantation, the method comprising the step of:
creating a cavity in a vertebral body;
cutting a hole through either a lower or an upper endplate of the vertebral body and through the nucleus pulposus of an intervertebral disc adjacent thereto, thereby creating an opening in the intervertebral disc;
implanting a compressible member into the opening in the intervertebral disc; and
implanting a fixation member into the cavity in the first vertebral body,
wherein:
(i) the compressible member comprises a base member that is radially adjustable to be wider than the hole cut in the vertebral body through which the compressible member is implanted, and
(ii) the step of implanting the compressible member into the opening comprises the steps of: (a) maneuvering the base member of the compressible member so that it passes through the hole and into the opening; and (b) radially adjusting the base member so that it substantially covers the hole.
56. The method according to claim 55 , further comprising the step of creating a seat in an endplate of a second vertebral body on the other side of the intervertebral disc in which the opening is formed.
57. A drill guide for use in spinal surgery, comprising a body having a first leg and a second leg, wherein:
(A) the first leg is dimensioned to be fixed relative to an intervertebral prosthetic member mounted in a cavity of a first vertebral body,
(B) the second leg is dimensioned to extend from the first leg, adjacent the first vertebral body, to a free end, adjacent at least one of an intervertebral disc and a second vertebral body, and
(C) the second leg includes at least one drilling channel extending through the second leg and the free end of the second leg comprises a drill positioning block through which the at least one drilling channel extends.
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Also Published As
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US20080215153A1 (en) | 2008-09-04 |
US8057549B2 (en) | 2011-11-15 |
EP1651150A2 (en) | 2006-05-03 |
WO2005013852A3 (en) | 2006-01-12 |
WO2005013852A2 (en) | 2005-02-17 |
US20120059479A1 (en) | 2012-03-08 |
EP1651150A4 (en) | 2009-11-11 |
EP1651150B1 (en) | 2021-03-24 |
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