LAMINOPLASTY DEVICE

20180078289 ยท 2018-03-22

    Inventors

    Cpc classification

    International classification

    Abstract

    Fixation devices and methods for stabilization of the lamina after laminoplasty are described. The device comprises of a plate with several holes that receive bone fasteners. The plate is curved at the ends to contour to the vertebral structure and has appendages to engage the displaced lamina in a fixed position. Alternatively, the plate has a bone fusion spacer in the middle to engage and fuse the lamina in the displaced position. Several methods of dynamically stabilizing the lamina after either the open door, double door or expansive laminoplasty technique are provided.

    Claims

    1. A bone fixation device comprising at least one elongated plate having a proximal end and a distal end, the plate is adapted to engage portions of the lamina and the facet, the plate includes at least one hollow spacer, wherein the hollow spacer includes at least one fusion material.

    2. The device of claim 1, wherein the plate comprises magnetic resonance compatible material.

    3. The device of claim 1, wherein the fusion materials is selected from the group consisting of allograft bone, autograft bone, xenograft bone, bone morphogenic protein, and hydroxyapatite.

    4. The device of claim 1, wherein the spacer includes at least one opening at the top to receive materials and a solid floor to prevent migration of the material into the spinal canal.

    5. The device of claim 1, wherein the plate is individually configured for each patient's anatomy.

    6. The device of claim 1, wherein the elongated plate having at least one appendage portion for engaging a portion of the lamina.

    7. The device of claim 1, wherein the elongated plate having at least one appendage for engaging a portion of the facet.

    8. The device of claim 1, wherein the elongated plate terminates with an upwardly extending portion for engaging a portion of the facet.

    9. The device of claim 1, wherein the elongated plate terminates with a downwardly extending portion for engaging a portion of the lamina.

    10. The device of claim 1, wherein the elongated plate including at least one appendage to secure the elongated plate to a portion of the lamina.

    11. A bone stabilization device comprising at least one elongated plate configured to engage portions of the lamina and the facet, wherein the elongated plate having at least one appendage portion for engaging a portion of the facet, and wherein the elongated plate terminates with an upwardly extending portion for engaging a portion of the lamina.

    12. The device of claim 11, wherein the elongated plate includes a hollow spacer, and wherein the hollow spacer including fusion material.

    13. The device of claim 11, wherein the fusion materials is selected from the group consisting of allograft bone, autograft bone, xenograft bone, bone morphogenic protein, and hydroxyapatite.

    14. The device of claim 11, wherein the plate is individually configured for each patient's anatomy.

    15. The device of claim 11, wherein the elongated plate having at least one appendage portion for engaging a portion of the lamina.

    16. The device of claim 11, wherein the elongated plate having at least one appendage for engaging a portion of the facet.

    17. A device comprising at least one elongated plate configured to engage portions of the lamina and the facet, wherein the elongated plate having at least one appendage for engaging a portion of the facet, the appendage including at least one screw hole, and wherein the elongated plate terminates with an upwardly extending portion for engaging a portion of the lamina, and wherein the upwardly extending portion includes at least one screw hole for engaging the lamina.

    18. The device of claim 17, wherein the elongated plate includes a hollow spacer, and wherein the hollow spacer including fusion material.

    19. The device of claim 18, wherein the fusion materials is selected from the group consisting of allograft bone, autograft bone, xenograft bone, bone morphogenic protein, and hydroxyapatite.

    20. The device of claim 17, wherein at least one appendage is arcuate.

    21. The device of claim 17, wherein the at least one elongated plate is curved.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0017] FIG. 1 is a top view of one embodiment of the plate.

    [0018] FIG. 2 is a side view of the plate.

    [0019] FIG. 3 is a cross section of the vertebra following an open door laminoplasty with the plate shown in FIG. 2 in place.

    [0020] FIG. 4 is a side view of another embodiment of the plate.

    [0021] FIG. 5 is a cross section of the vertebra following an open door laminoplasty with the plate shown in FIG. 4 in place.

    [0022] FIG. 6 is a top view of another embodiment of the plate.

    [0023] FIG. 7 is a sectional side view of the plate.

    [0024] FIG. 8 is a side view of another embodiment of the plate.

    [0025] FIG. 9 is a side view of another embodiment of the plate.

    [0026] FIG. 10 is a sectional side view of another embodiment of the plate.

    [0027] FIG. 11 is a sectional side view of another embodiment of the plate.

    [0028] FIG. 12 is a sectional side view of another embodiment of the plate.

    [0029] FIG. 13 is a sectional side view of another embodiment of the plate.

    [0030] FIG. 14 is a sectional side view of another embodiment of the plate.

    [0031] FIG. 15 is a sectional side view of another embodiment of the plate.

    [0032] FIG. 16 is a top view of another embodiment of the plate.

    [0033] FIG. 17 is a side view of the plate.

    [0034] FIG. 18 is a top view of another embodiment of the plate.

    [0035] FIG. 19 is a side view of the plate.

    [0036] FIG. 20 is a cross section of the vertebra following a trap door laminoplasty with the plate shown in FIG. 17 in place.

    [0037] FIG. 21 is a cross section of the vertebra following a trap door laminoplasty with the plate shown in FIG. 19 in place.

    [0038] FIG. 22 is a side view of another embodiment of the plate.

    [0039] FIG. 23 is a sectional side view of the plate.

    [0040] FIG. 24 is a side view of another embodiment of the plate.

    [0041] FIG. 25 is a side view of another embodiment of the plate with a spacer.

    [0042] FIG. 26 is a top view of the device shown in FIG. 25.

    [0043] FIG. 27 is a sectional side view of the device taken along line A in FIG. 26.

    [0044] FIG. 28 is a top view of another embodiment of the unitary plate and spacer device.

    [0045] FIG. 29 is a side view of the device.

    [0046] FIG. 30 is a sectional side view of the device.

    [0047] FIG. 31 is a top view of another embodiment of the unitary plate and spacer device.

    [0048] FIG. 32 is a side view of the device.

    [0049] FIG. 33 is a sectional side view of the device.

    [0050] FIG. 34 is a side view of another embodiment of the plate with a spacer.

    [0051] FIG. 35 is a top view of another embodiment of the plate with a spacer.

    [0052] FIG. 36 is sectional side view taken along line B in FIG. 35.

    [0053] FIG. 37 is a cross section of the vertebra following a trap door laminoplasty with the device shown in FIG. 35 in place.

    [0054] FIG. 38 is a top view of another embodiment of the unitary plate and spacer device.

    [0055] FIG. 39 is a side view of the device.

    [0056] FIG. 40 is a sectional side view of the device.

    [0057] FIG. 41 is a side view of another embodiment of the plate with a spacer.

    [0058] FIG. 42 is a top view of another embodiment of the plate with a spacer.

    [0059] FIG. 43 is sectional side view taken along line C in FIG. 35.

    [0060] FIG. 44 is a cross section of the vertebra following a trap door laminoplasty with the device shown in FIG. 42 in place.

    DETAILED DESCRIPTION OF THE EMBODIMENTS

    [0061] The technique of open-door laminoplasty stabilization without laminar fusion undertaken with the use of the plates is illustrated in FIGS. 1-5. The plate has a top surface 1 with bone screw holes at the ends 2 and 3. The ends have an upward angle at one end 4 and downward angle at the other 5. In one embodiment as seen on the side view in FIG. 2, there is a hook appendage 7 perpendicular to the plate to engage the lamina at one end and a straight appendage 6 at the other end to secure to the facet. In another embodiment of the plate as seen in FIG. 4, there is only one appendage 7 at the end prior to the downward angle of the plate. The implanted construct is seen in FIGS. 3 and 5. The plate is secured to the lamina 11 via bone screw 10 and facet 8 via bone screw 9. The hook 7 secures the lamina in the displaced laminoplasty position. As seen in FIG. 3, the additional straight appendage 6 at the facet end allows the plate to rest on the facet 8.

    [0062] In another embodiment, the plate 12 as shown in FIG. 6 comprises a lamina engaging portion with screw hole 13 and facet engaging portion with multiple screw holes. The plates can have straight appendages 15 and 16 prior to the angle at both sides as shown in FIG. 7, a straight appendage 17 on the facet side as shown in FIG. 17, a straight appendage 18 on the lamina side as shown in FIG. 9, a curved appendage 19 at the lamina side and a straight appendage 20 at the facet side as shown in FIG. 10, curved appendages 21 and 22 prior to the angle at both sides as shown in FIG. 11, a curved appendage only 23 at the lamina side as shown in FIG. 12, or a curved appendage 24 at the facet side as shown in FIG. 13.

    [0063] In another embodiment as shown in FIG. 14, the plate has a central portion 25, a lamina engaging end 30 and a facet engaging end with screw holes 28. The lamina engaging end 30 has a hook extension 26 which engages the lamina end into the space 27. The facet engaging end also has a perpendicular extension 29. In a variation of the above embodiment as seen in FIG. 15, comprising of a lamina engaging end 32 and a facet engaging end 31 without an appendage. Other embodiments of the plate can comprise of spikes or clamps at the lamina or facet bone engaging ends with or without screw placement.

    [0064] For the trap-door technique of laminoplasty, stabilization without laminar fusion is undertaken with the use of the plates alone. In one embodiment of the plate as illustrated in FIGS. 16 and 17, the plate has a top surface 33 and screw holes at both ends 34 and 35. The appendages 36 and 37 secure the displaced lamina and the curvatures at both ends 38 and 39 allow attachment to the lamina. The implanted plate is shown in FIG. 20 with bone screws 51 and 52 securing it to the lamina on both sides.

    [0065] In another embodiment as illustrated in FIGS. 18 and 19, the plate is curved at the ends 47 and 48. The plate has a top surface 44 with bone screw holes 41 and 42 for laminar fixation and holes 40 and 43 for facet fixation on both sides. The appendages 45 and 46 secure the displaced lamina. The implanted plate is shown in FIG. 21 with bone screws 53 and 54 securing it to the facets on both sides.

    [0066] The trap door laminoplasty implant can comprise of straight or curved appendages. FIGS. 22 and 23 illustrates the implant with a central portion 55 and angled ends 56 and 57 with screw holes 60 and 61 for fixation to the lamina. The appendages 58 and 59 in the middle are straight. FIG. 24 illustrates the implant with curved appendages 62 and 63. Other embodiments of the implant can also comprise of hook shaped appendages to secure the lamina ends.

    [0067] In one embodiment of the trap door laminoplasty fusion device as illustrated in FIGS. 25-27, the device has a spacer in the middle 64, an end 65 that engages with the facet, and an end 66 that engages with the displaced lamina edge. The plates at the distal ends are angled upwards 67 at one end with screw holes 69 to allow fixation to the facet via a screw and angled downwards 68 with screw holes 70 to allow fixation to the lamina via a screw. The spacer 64 in the middle is attached to the plate with a screw through the screw hole 71. The spacer is made of a fusion material like allograft bone, autograft bone, xenograft bone, bone morphogenic protein, or hydroxyapatite to fuse the lamina in the fixed position provided by the device.

    [0068] In another embodiment of the trap door laminoplasty fusion device as illustrated in FIGS. 28-30, the device has a spacer in the middle with a top surface opening 79, one end 74 that engages with the facet, and another end 73 that engages with the lamina. The plate is angled upwards 76 at one end with screw holes 78 to allow fixation to the facet via a screw and angled downwards 75 at the other end with screw hole 77 to allow fixation to the lamina via a screw. The spacer in the middle is hollow 80 with a top contiguous with the plate. The hollow spacer has open ends 73 and 74. The spacer can be packed with a fusion material like allograft or autograft bone, bone morphogenic protein, or hydroxyapatite to fuse the lamina to the facet in the fixed position provided by the device. The spacer has a partial or complete opening 79 at the top to allow for packing of the bone fusion material and a solid floor 81 to prevent migration of the fusion material into the spinal canal.

    [0069] In one embodiment of the open door laminoplasty fusion device as illustrated in FIGS. 31-33, the device has a spacer 89 in the middle with a top surface opening 82, one end 83 and another end 84 that engage with the lamina. The plate is angled downwards 85 and 86 at both ends with screw holes 87 and 88 to allow fixation to the lamina via a screw. The spacer 89 in the middle is hollow 90 with a top contiguous with the plate. The hollow spacer has open ends 83 and 84. The spacer can be packed with a fusion material like allograft or autograft bone, bone morphogenic protein, or hydroxyapatite to fuse the lamina in the fixed position provided by the device. The spacer has a partial or complete opening 82 at the top to allow for packing of the bone fusion material and a solid floor 91 to prevent migration of the fusion material into the spinal canal.

    [0070] In another embodiment of the open door laminoplasty fusion device as illustrated in FIG. 34, the device has downward angled distal ends 92 and 94 and a bone fusion spacer 93 in the middle attached to the central plate portion 31 with a biocompatible adhesive.

    [0071] In another embodiment as shown in FIGS. 35-37, the plate at the distal ends is angled with screw holes 96 and 98 to allow fixation to the lamina via screws. The spacer 93 in the middle is attached to the plate with a screw through the central plate screw hole 97. The spacer ends 99 and 100 engage the lamina ends. The spacer is made of a fusion material like allograft bone, autograft bone, or bone morphogenic protein. The open door laminoplasty technique as shown in FIG. 37 involves removal of the spinous process and creation of unicortical laminoplasty grooves 101 and 102 at the junction of the lamina and facet on both sides. The displaced lamina are then maintained in that position with the device with a spacer in the middle secured to the plate with the bone screw 105. The fusion device also has plates with bone screw receiving holes that allow fixation of the plate with bone screws 103 and 104 securing the device to the lamina.

    [0072] In another embodiment of the open door laminoplasty fusion device as illustrated in FIGS. 38-40, the device has a spacer 106 in the middle with a top surface opening 107, one end 108 and another end 109 that engage with the lamina. The plate has a lazy L-shape 110 and 111 on both sides with screw holes 112 and 113 to allow fixation to the facets via a screw. The spacer 106 in the middle is hollow with a top contiguous with the plate. The hollow spacer has open ends 108 and 109. The spacer can be packed with a fusion material like allograft or autograft bone, bone morphogenic protein, or hydroxyapatite to fuse the lamina in the fixed position provided by the device. The spacer has a partial or complete opening 107 at the top to allow for packing of the bone fusion material and a solid floor 114 to prevent migration of the fusion material into the spinal canal.

    [0073] In another embodiment of the laminoplasty fusion device for the open door laminoplasty technique as illustrated in FIGS. 41-44, the device has a spacer in the middle 117 and ends 115 and 116 that engage with the facet with screws. The plates at the distal ends are angled both ends with screw holes 119 and 120. The spacer 64 in the middle is attached to the plate 118 either with a biocompatible adhesive as shown in FIG. 41 or a screw placed through the central plate hole 121. The spacer is made of a fusion material like allograft bone, autograft bone, xenograft bone, bone morphogenic protein, or hydroxyapatite to fuse the lamina in the fixed position provided by the device. The plate also has screw holes 122 and 123 if needed for screw placement into the lamina. FIG. 44 illustrates the lamina fusion device in place following an open door laminoplasty. The displaced lamina are then maintained in that position with a lamina fixation device with a spacer in the middle 117 with the plate fixated to the facets through bone screws 124 and 125.

    [0074] The length of the plates as well as the spacer can vary depending on the laminar displacement desired by the surgeon with either the open door or trap door laminoplasty technique.

    [0075] The laminoplasty plates can be made of metal, polymers, ceramics, composites, and/or any bio-compatible material with sufficient strength to maintain the open position of the divided lamina. The plates can be constructed of titanium or titanium alloy for MRI imaging compatibility. It could also be made of a bio-absorbable material (polyesters, poly amino acids, polyanhydrides, polyorthoesters, polyurethanes, polycarbonates, homopolymers, copolymers of poly lactic acid and poly glycolic acid, copolyesters of e-caprolactone, trimethylene carbonate, and para-dioxanone), or allograft or xenograft bone that is absorbed by the body over time once the divided lamina have fused. Alternatively, it could be made of a radiolucent material (polyetheretherketone), plastic, or a combination of plastic and metal to reduce CT and MRI imaging artifact.

    [0076] The laminoplasty plates can be of a unitary construction, such that the spacer portion, lamina engaging portions and/or the facet engaging portions can be integral or formed from a single piece of material. Alternative embodiments contemplate that the components of the laminoplasty plate can be non-integral, and can be attached to and/or coupled to other components of laminoplasty plate.

    [0077] The spacer can be made of any bio-compatible material, including autograft, allograft or xenograft, and can be resorbable or non-resorbable in nature. Bone fusion material can include demineralized bone matrix, bone morphogenic protein, hydroxyapatite, and combinations thereof. Resorbable materials can include polylactide, polyglycolide, tyrosine-derived polycarbonate, polyanhydride, polyorthoester, polyphosphazene, calcium phosphate, hydroxyapatite, bioactive glass, and combinations thereof. Further examples of non-resorbable materials are non-reinforced polymers, carbon-reinforced polymer composites, PEEK (polyetheretherketone), and PEAK (polyaryletherketone) composites, shape-memory alloys like nitinol, titanium, titanium alloys, cobalt chrome alloys, stainless steel, ceramics and combinations thereof and others as well.

    [0078] While the present invention has been described in conjunction with preferred embodiments and methods, it is intended that the description and accompanying drawings shall be interpreted as only illustrative of the invention. It is evident that those skilled in the art may make numerous uses and modifications of and departures from the specific embodiments described herein without departing from the inventive concept.