Search Images Maps Play YouTube News Gmail Drive More »
Sign in
Screen reader users: click this link for accessible mode. Accessible mode has the same essential features but works better with your reader.

Patents

  1. Advanced Patent Search
Publication numberUS20050187625 A1
Publication typeApplication
Application numberUS 11/031,362
Publication dateAug 25, 2005
Filing dateJan 7, 2005
Priority dateOct 20, 2003
Also published asCA2542833A1, EP1684674A2, EP1684674A4, US7776093, US20050154459, WO2005041816A2, WO2005041816A3
Publication number031362, 11031362, US 2005/0187625 A1, US 2005/187625 A1, US 20050187625 A1, US 20050187625A1, US 2005187625 A1, US 2005187625A1, US-A1-20050187625, US-A1-2005187625, US2005/0187625A1, US2005/187625A1, US20050187625 A1, US20050187625A1, US2005187625 A1, US2005187625A1
InventorsHoward Wolek, Francesco Larosa, Jeffrey Kozak, Mark Lorenz, Michael Zindrick
Original AssigneeHoward Wolek, Francesco Larosa, Kozak Jeffrey A., Lorenz Mark A., Zindrick Michael R.
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Vertebral body replacement apparatus and method
US 20050187625 A1
Abstract
Various embodiments of the present invention relate to an apparatus for vertebral body replacement and methods associated therewith. In one embodiment, a vertebral body replacement apparatus may be used to correct and stabilize the spine (e.g., the thoracolumbar spine (T1-L5)). In another embodiment, a vertebral body (e.g., a diseased and/or damaged vertebral body) that has been resected or excised (e.g., for the treatment of a tumor or trauma) may be replaced (with the height of the resected or excised vertebral body being substantially replaced and restored by the apparatus of the present invention).
Images(25)
Previous page
Next page
Claims(31)
1. A vertebral body replacement apparatus for placement between a first vertebra and a second vertebra, comprising:
a first endplate including a generally outward facing surface for contacting at least a portion of a lower face of the first vertebra and a generally inward facing surface including thereon at least two pockets and at least two protrusions, wherein at least one protrusion is disposed within each of the pockets;
a second endplate including a generally outward facing surface for contacting at least a portion of an upper face of the second vertebra and a generally inward facing surface including thereon at least two pockets and at least two protrusions, wherein at least one protrusion is disposed within each of the pockets;
a first lateral spacer including at least one aperture; and
a second lateral spacer including at least one aperture;
wherein, when the first and second lateral spacers are disposed between the first and second endplates such that the first endplate is above the first and second lateral spacers and the second endplate is below the first and second lateral spacers, a first pair of opposed pockets of the first and second endplates are configured to receive therein at least a part of the first lateral spacer and a second pair of opposed pockets of the first and second endplates are configured to receive therein at least a part of the second lateral spacer; and
wherein the aperture of the first lateral spacer is configured to receive at least one of the protrusions of each of the first and second endplates when the first lateral spacer is received within the first pair of pockets and the aperture of the second lateral spacer is configured to receive at least one of the protrusions of each of the first and second endplates when the second lateral spacer is received within the second pair of pockets.
2. The apparatus of claim 1, wherein at least one of: (a) the mating of each of the protrusions with a respective one of the apertures provides lateral alignment between each of the first endplate, the second endplate, the first lateral spacer and the second lateral spacer; and (b) the mating of each of the lateral spacers with a respective pocket provides lateral alignment between each of the first endplate, the second endplate, the first lateral spacer and the second lateral spacer.
3. The apparatus of claim 2, wherein at least one of the protrusions and at least one of a respective one of the apertures includes a locking mechanism for locking the protrusion in the aperture.
4. The apparatus of claim 3, wherein the locking mechanism of the protrusion and the locking mechanism of the aperture are configured to permit unlocking thereof.
5. The apparatus of claim 4, wherein the locking mechanism of the protrusion comprises a raised ridge and the locking mechanism of the aperture comprises an indentation.
6. The apparatus of claim 4, wherein the locking mechanism of the protrusion comprises a tab and the locking mechanism of the aperture comprises a slot.
7. The apparatus of claim 1, wherein the aperture of the first lateral spacer extends through the first lateral spacer and the aperture of the second lateral spacer extends through the second lateral spacer.
8. The apparatus of claim 1, wherein each of the first and second lateral spacers includes a respective upper aperture adjacent the generally inward facing surface of the first endplate for receiving at least one of the protrusions of the first endplate and each of the first and second lateral spacers includes a respective lower aperture adjacent the generally inward facing surface of the second endplate for receiving at least one of the protrusions of the second endplate.
9. The apparatus of claim 1, wherein each of the first and second lateral spacers has a lordotic angle between about 0-8 degrees.
10. The apparatus of claim 1, wherein the generally outward facing surface of the first endplate is textured and the generally outward facing surface of the second endplate is textured.
11. The apparatus of claim 10, wherein the texture is configured to resist expulsion of the apparatus from between the first and second vertebrae.
12. The apparatus of claim 10, wherein the texture is configured to aid in insertion of the apparatus between the first and second vertebrae.
13. The apparatus of claim 10, wherein the texture is configured to aid in permitting bony ingrowth from the first and second vertebrae.
14. The apparatus of claim 10, wherein the texture is selected from the group including: (a) teeth; (b) grooves; and (c) ridges.
15. The apparatus of claim 1, wherein the first endplate, the second endplate, the first lateral spacer and the second lateral spacer are configured to define at least one hollow area when the first and second lateral spacers are disposed between the first and second endplates such that the first endplate is above the first and second lateral spacers and the second endplate is below the first and second lateral spacers.
16. The apparatus of claim 15, wherein the hollow area is configured to aid in permitting bony ingrowth from the first and second vertebrae.
17. The apparatus of claim 1, wherein at least one of the first endplate, the second endplate, the first lateral spacer and the second lateral spacer comprises polyetheretherketone.
18. The apparatus of claim 1, wherein at least one of the first endplate, the second endplate, the first lateral spacer and the second lateral spacer includes a marker comprising a material which is substantially opaque to x-rays.
19. The apparatus of claim 1, further comprising at least one additional spacer disposed laterally between the first lateral spacer and the second lateral spacer.
20. The apparatus of claim 1, further comprising a mechanism for connecting the apparatus to a means for supplemental fixation.
21. The apparatus of claim 20, wherein the means for supplemental fixation is selected from the group including: (a) one or more screws; (b) one or more rods; (c) one or more staples; (d) one or more washers; (e) one or more cross connectors; and (f) one or more hooks.
22. A method of constructing a vertebral body replacement apparatus for placement between a first vertebra and a second vertebra, comprising:
selecting a first endplate including a generally outward facing surface for contacting at least a portion of a lower face of the first vertebra and a generally inward facing surface including thereon at least two pockets and at least two protrusions, wherein at least one protrusion is disposed within each of the pockets;
selecting a second endplate including a generally outward facing surface for contacting at least a portion of an upper face of the second vertebra and a generally inward facing surface including thereon at least two pockets and at least two protrusions, wherein at least one protrusion is disposed within each of the pockets;
selecting a first lateral spacer including at least one aperture;
selecting a second lateral spacer including at least one aperture; and
placing the first and second lateral spacers between the first and second endplates such that the first endplate is above the first and second lateral spacers and the second endplate is below the first and second lateral spacers and such that a first pair of opposed pockets of the first and second endplates receive therein at least a part of the first lateral spacer and a second pair of opposed pockets of the first and second endplates receive therein at least a part of the second lateral spacer;
wherein the aperture of the first lateral spacer receives at least one of the protrusions of each of the first and second endplates when the first lateral spacer is received within the first pair of pockets and the aperture of the second lateral spacer receives at least one of the protrusions of each of the first and second endplates when the second lateral spacer is received within the second pair of pockets.
23. The method of claim 22, wherein at least one of: (a) the mating of each of the protrusions with a respective one of the apertures provides lateral alignment between each of the first endplate, the second endplate, the first lateral spacer and the second lateral spacer; and (b) the mating of each of the lateral spacers with a respective pocket provides lateral alignment between each of the first endplate, the second endplate, the first lateral spacer and the second lateral spacer.
24. The method of claim 23, wherein at least one of the protrusions and at least one of a respective one of the apertures includes a locking mechanism for locking the protrusion in the aperture.
25. The method of claim 24, wherein the locking mechanism of the protrusion and the locking mechanism of the aperture are configured to permit unlocking thereof.
26. The method of claim 22, wherein the aperture of the first lateral spacer extends through the first lateral spacer and the aperture of the second lateral spacer extends through the second lateral spacer.
27. The method of claim 22, wherein each of the first and second lateral spacers includes a respective upper aperture adjacent the generally inward facing surface of the first endplate for receiving at least one of the protrusions of the first endplate and each of the first and second lateral spacers includes a respective lower aperture adjacent the generally inward facing surface of the second endplate for receiving at least one of the protrusions of the second endplate.
28. The method of claim 22, wherein the steps are carried out in the order recited.
29. A method of stabilizing a spine, comprising:
selecting, for a vertebral body replacement apparatus, a first endplate including a generally outward facing surface for contacting at least a portion of a lower face of the first vertebra and a generally inward facing surface including thereon at least two pockets and at least two protrusions, wherein at least one protrusion is disposed within each of the pockets;
selecting, for the vertebral body replacement apparatus, a second endplate including a generally outward facing surface for contacting at least a portion of an upper face of the second vertebra and a generally inward facing surface including thereon at least two pockets and at least two protrusions, wherein at least one protrusion is disposed within each of the pockets;
selecting, for the vertebral body replacement apparatus, a first lateral spacer including at least one aperture;
selecting, for the vertebral body replacement apparatus, a second lateral spacer including at least one aperture;
constructing the vertebral body replacement apparatus by placing the first and second lateral spacers between the first and second endplates such that the first endplate is above the first and second lateral spacers and the second endplate is below the first and second lateral spacers, such that a first pair of opposed pockets of the first and second endplates receive therein at least a part of the first lateral spacer and a second pair of opposed pockets of the first and second endplates receive therein at least a part of the second lateral spacer, such that the aperture of the first lateral spacer receives at least one of the protrusions of each of the first and second endplates when the first lateral spacer is received within the first pair of pockets and such that the aperture of the second lateral spacer receives at least one of the protrusions of each of the first and second endplates when the second lateral spacer is received within the second pair of pockets; and
placing the vertebral body replacement apparatus between the first and second vertebrae.
30. The method of claim 29, wherein the vertebral body replacement apparatus is configured to be placed in one of the thoracic and lumbar spinal regions.
31. The method of claim 29, wherein the steps are carried out in the order recited.
Description
    CROSS-REFERENCE TO RELATED APPLICATIONS
  • [0001]
    This application is a continuation in part of U.S. application Ser. No. 10/968,586 filed Oct. 19, 2004, which claims the benefit under 35 U.S.C. 119(e) of U.S. Provisional Application Ser. No. 60/512,716, filed Oct. 20, 2003.
  • FIELD OF THE INVENTION
  • [0002]
    Various embodiments of the present invention relate to an apparatus for vertebral body replacement and methods associated therewith.
  • [0003]
    In one embodiment, a vertebral body replacement apparatus may be used to correct and stabilize the spine (e.g., the thoracolumbar spine (T1-L5)).
  • [0004]
    In another embodiment, a vertebral body (e.g., a diseased and/or damaged vertebral body) that has been resected or excised (e.g., for the treatment of a tumor or trauma) may be replaced (with the height of the resected or excised vertebral body being substantially replaced and restored by the apparatus of the present invention).
  • BACKGROUND OF THE INVENTION
  • [0005]
    Examples of various patent documents in the spinal implant area include the following:
  • [0006]
    U.S. Pat. No. 5,192,327 to Brantigan relates to a surgical prosthetic implant for vertebrae. More particularly, surgical prosthetic modular implants used singularly or stacked together are provided to support and fuse together adjacent vertebrae or to totally or partially replace one or more vertebrae in a vertebral column. The implants are rigid annular plugs, dimensionally similar to normal vertebral bodies, have simplified oval or hemi-oval shapes with ridged faces to engage adjacent vertebral bodies to resist displacement and allow bone ingrowth and fusion and to interdigitate with the ridges of an adjacent plug for modular stacking to allow variability of ultimate implant height. The implants can be provided in sets of different thicknesses and are internally grooved to receive an upstanding connecting bar to bind together the individual stacked implants into a stable unit. The annular implants have ample spaces to allow ingrowth of blood capillaries and packing of bone graft and are preferably made of a radiolucent material, preferably biocompatible carbon fiber reinforced polymers or are alternately made of traditional orthopaedic implant materials such as nickel, chromium, cobalt, stainless steel or titanium.
  • [0007]
    U.S. Pat. No. 5,397,364 to Kozak et al. relates to an anterior interbody fusion device. More particularly, an interbody fusion device includes a pair of lateral spacers and a pair of central spacers, each sized for percutaneous introduction through a disc resection portal in the disc annulus. Each of the lateral spacers includes opposing side faces defining a channel therein, while each of the central spacers includes arms at their opposite ends configured to be received within a channel of a corresponding lateral spacer. The arms and channels are interlocking to prevent separation of the components once assembled within the intradiscal space. The assembly of the central and lateral spacers defines a cavity therebetween for insertion of bone graft material. The central and lateral spacers are configured so that the bone graft cavity is oriented over the weakest, but most vascular and biologically active, bone of the vertebral body, while the lateral spacers are situated adjacent the disc annulus and over the strongest vertebral bone.
  • [0008]
    U.S. Pat. No. 6,159,211 to Boriani et al. relates to a stackable cage system for corpectomy/vertebrectomy. More particularly, surgical prosthetic modular devices used singularly or stacked together are provided for use to replace excised vertebral tissue. The devices are rigid plugs, dimensionally similar to normal vertebral bodies, and have ridged faces to engage adjacent vertebral bodies or to interdigitate when stacked. Ridges extend in both the medial/lateral and anterior/posterior directions to prevent slipping in the anterior/posterior and medial/lateral directions respectively. A locking screw may be used to secure a stack to form a singular rigid prosthetic device. The devices are also provided with a plurality of threaded openings. In the method of this invention, a device is used to replace excised vertebral tissue, threaded bolts are inserted into the threaded openings, and other spine stabilization devices are attached to the bolts. In corporectomies, the device can be bolted to a plate, which in turn is fixed to adjacent vertebrae. In spondylectomies, the device can be fixed to a series of posteriorly placed rods.
  • [0009]
    U.S. Pat. No. 6,468,311 to Boyd et al. relates to a modular interbody fusion implant. More particularly, an interbody fusion device for engagement between vertebrae includes a pair of lateral spacers for spacing the vertebrae, and a connecting member adapted to couple together the lateral spacers when inserted between the vertebrae. The connecting member, individual lateral spacers, or the entire spinal spacer can be made of bone in order to promote fusion of the vertebrae. The modular construction permits use of bone segments otherwise unsuitable due to size or strength in stable fusion devices.
  • [0010]
    U.S. Patent Application No. 2003/0040799 in the name of Boyd et al. relates to a modular interbody fusion implant. More particularly, an interbody fusion device for engagement between vertebrae includes a pair of lateral spacers for spacing the vertebrae, and a connecting member adapted to couple together the lateral spacers when inserted between the vertebrae. The connecting member, individual lateral spacers, or the entire spinal spacer can be made of bone in order to promote fusion of the vertebrae. The modular construction permits use of bone segments otherwise unsuitable due to size or strength in stable fusion devices.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • [0011]
    FIG. 1 shows a perspective view of one embodiment of a vertebral body replacement implant assembly according to the present invention;
  • [0012]
    FIG. 2 shows another view of the implant assembly of FIG. 1 as it would look outside of the body;
  • [0013]
    FIGS. 3A and 3B show exploded perspective views of the implant assembly of FIGS. 1 and 2 (FIG. 3A shows an embodiment of the implant assembly from one angle and FIG. 3B shows an embodiment of the implant assembly from another angle);
  • [0014]
    FIG. 4 shows a perspective view of an endplate type component of an implant assembly according to an embodiment of the present invention;
  • [0015]
    FIG. 5 shows a perspective view of a non-lordotic lateral spacer type component of an implant assembly according to an embodiment of the present invention;
  • [0016]
    FIG. 6 shows a perspective view of a lordotic lateral spacer type component of an implant assembly according to an embodiment of the present invention;
  • [0017]
    FIG. 7 shows a plan view of an implant assembly according to an embodiment of the present invention;
  • [0018]
    FIG. 8 shows section A-A of FIG. 7;
  • [0019]
    FIG. 9 shows Detail B of FIG. 8;
  • [0020]
    FIG. 10 shows a plan view of another embodiment of the present invention;
  • [0021]
    FIGS. 11-14 show perspective views of other embodiments of the present invention;
  • [0022]
    FIGS. 15 and 16 show, respectively, a perspective view and an exploded perspective view of another embodiment of the present invention;
  • [0023]
    FIGS. 17A-17G show perspective views of various components according to an embodiment of the present invention;
  • [0024]
    FIGS. 18, 19A, 19B, 20A, 20B and 21 show perspective views of various implant assemblies using the components of FIGS. 17A-17G;
  • [0025]
    FIGS. 22A-22E show various views of an implant assembly using the components of FIGS. 17A-17G;
  • [0026]
    FIG. 23 shows a perspective view of another embodiment of a vertebral body replacement implant assembly according to the present invention;
  • [0027]
    FIG. 24 shows another view of the implant assembly of FIG. 23 as it would look outside of the body;
  • [0028]
    FIG. 25 shows an exploded perspective view of the implant assembly of FIGS. 23 and 24;
  • [0029]
    FIG. 26 shows a perspective view of an endplate type component of an implant assembly according to an embodiment of the present invention;
  • [0030]
    FIG. 27 shows a perspective view of a non-lordotic lateral spacer type component of an implant assembly according to an embodiment of the present invention;
  • [0031]
    FIG. 28 shows a perspective view of a lordotic lateral spacer type component of an implant assembly according to an embodiment of the present invention;
  • [0032]
    FIG. 29 shows a plan view of an implant assembly according to an embodiment of the present invention;
  • [0033]
    FIG. 30 shows section B-B of FIG. 29; and
  • [0034]
    FIG. 31 shows Detail C of FIG. 30.
  • [0035]
    Among those benefits and improvements that have been disclosed, other objects and advantages of this invention will become apparent from the following description taken in conjunction with the accompanying figures. The figures constitute a part of this specification and include illustrative embodiments of the present invention and illustrate various objects and features thereof.
  • DETAILED DESCRIPTION OF THE INVENTION
  • [0036]
    Detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely illustrative of the invention that may be embodied in various forms. In addition, each of the examples given in connection with the various embodiments of the invention are intended to be illustrative, and not restrictive. Further, the figures are not necessarily to scale, some features may be exaggerated to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the present invention.
  • [0037]
    Referring now to FIG. 1, one embodiment of a vertebral body replacement implant assembly according to the present invention is shown. As seen in this FIG. 1, Implant Assembly 101 may be implanted between First Vertebra 103 a and Second Vertebra 103 b (FIG. 2 shows another view of Implant Assembly 101 as it would look outside of the body). Of note, Implant Assembly 101 may be formed of a number of components fitted together.
  • [0038]
    More particularly, as seen in FIGS. 3A and 3B, Implant Assembly 101 may be formed of, for example, four components: (a) First Endplate 301 (e.g., a top Endplate), Second Endplate 303 (e.g., a bottom Endplate), First Lateral Spacer 305 and Second Lateral Spacer 307.
  • [0039]
    First Endplate 301 may include: First Offset Aperture 301 a (e.g., offset relative to a centerline of Endplate 301); Second Offset Aperture 301 b (e.g., offset relative to a centerline of Endplate 301); Protrusions 301 c and 301 d (these Protrusions are seen most clearly in FIG. 3B; although in this embodiment there are four such Protrusions (two adjacent First Offset Aperture 301 a and two adjacent Second Offset Aperture 301 b) any number of protrusions may be utilized); Insertion Tool Mating Aperture 301 e (for mating with an insertion tool (not shown)); and various grooves disposed along the top surface (the grooves are not separately numbered in the Figs.).
  • [0040]
    Likewise, Second Endplate 303 may include: First Offset Aperture 303 a (e.g., offset relative to a centerline of Endplate 303); Second Offset Aperture 303 b (e.g., offset relative to a centerline of Endplate 303); Protrusions 303 c-303 f; Insertion Tool Mating Aperture 303 g (for mating with an insertion tool (not shown)); and various grooves disposed along the bottom surface (the grooves are not separately numbered in the Figs.).
  • [0041]
    Further, First Lateral Spacer 305 may include: Main Aperture 305 a (which may at least partially line-up with First Offset Aperture 301 a and First Offset Aperture 303 a; various Auxiliary Apertures (not separately numbered in the Figs.); and various grooves disposed along the top surface and the bottom surface (the grooves are not separately numbered in the Figs.).
  • [0042]
    Likewise, Second Lateral Spacer 307 may include: Main Aperture 307 a (which may at least partially line-up with Second Offset Aperture 301 b and Second Offset Aperture 303 b; various Auxiliary Apertures (not separately numbered in the Figs.); and various grooves disposed along the top surface and the bottom surface (the grooves are not separately numbered in the Figs.).
  • [0043]
    Of note, the embodiments of FIGS. 3A and 3B are similar, with the main differences being the shape of the internal centerline bosses on the inner faces of the First Endplate and Second Endplate and the fact that the Protrusions in the embodiment of FIG. 3A are essentially featureless (such that they provide lateral alignment/support) while the Protrusions of the embodiment of FIG. 3B provide locking features such as the ridges shown in the Fig. but not separately numbered (such that the ridges cooperate with mating indentations (shown in the Fig. but not separately numbered) in the First Lateral Spacer and the Second Lateral Spacer to provide both lateral alignment/support as well as up-down locking (e.g., removable locking) of the components). In another example (which example is intended to be illustrative and not restrictive), a tab and slot system may be utilized for locking.
  • [0044]
    Of further note, Implant Assembly 101 may provide for bony ingrowth and/or may be packed with bone matter. This may be accomplished via the hollow fenestrated design of the components (e.g., via First Offset Aperture 301 a; Second Offset Aperture 301 b; First Offset Aperture 303 a; Second Offset Aperture 303 b; Main Aperture 305 a; Main Aperture 307 a; and/or the various Auxiliary Apertures) and/or the hollow fenestrated design of the finished implant assembly (e.g., via the space(s) between First Lateral Spacer 305 and Second Lateral Spacer 307 at each end of the finished implant assembly).
  • [0045]
    In one set of examples (which examples are intended to be illustrative and not restrictive), Implant Assembly 101 may be provided in two footprint sizes. The “small” footprint may measure, for example, 28 mm wideŚ23 mm length (in this example each “small” footprint size Endplate may be 28 mm wideŚ23 mm length, and each Lateral Spacer may be 8 mm wideŚ23 mm length). The “large” footprint may measure, for example, 35 mm wideŚ28 mm length (in this example each “large” footprint size Endplate may be 35 mm wideŚ28 mm length, and each Lateral Spacer may be 8 mm wideŚ28 mm length). One or both footprint sizes may be available in height ranges from, for example, 12 mm to 60 mm (in increments of one millimeter, for example).
  • [0046]
    Reference will now be made to Tables 1-3, below, which identify example thicknesses of the components of a “large” implant assembly (of course, these examples are intended to be illustrative and not restrictive). More particularly, Table 1 identifies example thicknesses of a “large” End Plate (see, e.g., FIG. 4 for a perspective view of this type of component), Table 2 identifies example thicknesses of a “large” Non-Lordotic Lateral Spacer (see, e.g., FIG. 5 for a perspective view of this type of component) and Table 3 identifies example thicknesses of a “large” Lordotic Lateral Spacer (see, e.g., FIG. 6 for a perspective view of this type of component).
    TABLE 1
    (All measurements in mm)
    2 3 4
  • [0047]
    TABLE 2
    (All measurements in mm)
    8 10 12 14 16 21 26 31 36 41 46 51 56
  • [0048]
    TABLE 3
    (All measurements in mm)
    8 10 12 14 16 21 26 31 36 41 46 51 56
  • [0049]
    Reference will now be made to Tables 4-6, below, which identify example thicknesses of the components of a “small” implant assembly (of course, these examples are intended to be illustrative and not restrictive). More particularly, Table 4 identifies example thicknesses of a “small” End Plate (see, e.g., FIG. 4 for a perspective view of this type of component), Table 5 identifies example thicknesses of a “small” Non-Lordotic Lateral Spacer (see, e.g., FIG. 5 for a perspective view of this type of component) and Table 6 identifies example thicknesses of a “small” Lordotic Lateral Spacer (see, e.g., FIG. 6 for a perspective view of this type of component).
    TABLE 4
    (All measurements in mm)
    2 3 4
  • [0050]
    TABLE 5
    (All measurements in mm)
    8 10 12 14 16 21 26 31 36 41 46 51 56
  • [0051]
    TABLE 6
    (All measurements in mm)
    8 10 12 14 16 21 26 31 36 41 46 51 56
  • [0052]
    Referring now to construction of the implant assembly from its constituent components, it is noted that in one embodiment such construction may occur outside of the patient's body (e.g., outside of the wound). More particularly, after determining the correct height, footprint and/or lordotic requirement of the implant assembly, the surgeon may then select one or more lateral spacers (e.g., two) and/or one or more endplates (e.g., two) that would meet the requirements (e.g., a 30 mm tall implant assembly may utilize two lateral spacers of 26 mm tall and two 2 mm thick endplates). The components may be assembled by snapping the lateral spacers onto a first endplate and then snapping a second endplate onto the two lateral spacers. Such snapping construction may be carried out, for example, using a lip and undercut arrangement (see FIG. 7 (showing a plan view of an implant assembly according to an embodiment of the present invention), FIG. 8 (showing section A-A of FIG. 7), and FIG. 9 (showing Detail B of FIG. 8)). More particularly, with regard to such snapping construction, attention is directed to the features of FIG. 9 which show the undercut in the lateral spacer and the tapered lip on the endplate (wherein an interference may exist in the assembly until the tapered lip reaches the undercut and snaps into place creating a lock).
  • [0053]
    In another embodiment, some or all of the components may include or be made essentially entirely from polyetheretherketone (e.g., PEEK Optima). Of note, this PEEK polymer material has radiolucent properties, which may aid the surgeon in determining if fusion (e.g., in the operative site) has occurred. Since such PEEK material is essentially transparent to x-rays, markers (e.g., markers made of titanium) may be inserted into one or more of the components to give a surgeon a visual aid in determining the location of the component and/or entire implant assembly (e.g., both inter and postoperatively).
  • [0054]
    In another embodiment, Indications relating to use of the present invention may include (but not be limited to):
      • For use in thoracolumbar spine (i.e., T1 to L5) to replace a vertebral body (e.g., a diseased vertebral body) resected or excised (e.g., for the treatment of tumor(s)) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
      • For treating fracture(s) of the thoracic and/or lumbar spine.
      • To restore the biomechanical integrity of the anterior, middle, and/or posterior spinal column (e.g., even in the absence of fusion for a prolonged period).
      • For use with supplemental internal fixation. Such supplemental internal fixation may include (but not be limited to) any appropriate screws, rods, staples, washers, cross connectors, and/or posterior hooks.
  • [0059]
    In another embodiment, Contraindications relating to use of the present invention may include (but not be limited to):
      • Morbid obesity
      • Mental illness
      • Alcoholism and/or drug abuse
      • Pregnancy
      • Mental sensitivity/allergies
      • Severe osteopenia
      • Patients unwilling or unable to follow post-operative care instructions
      • Certain circumstances not identified above as an Indication (e.g., as identified by any appropriate care giver)
  • [0068]
    In another embodiment, one or more of the components and/or the implant assembly may have a tapered lead-in (e.g., for easy insertion).
  • [0069]
    In another embodiment, each lateral spacer may be capable of supporting the vertebral column.
  • [0070]
    In another embodiment, the textured surface of the components and/or the implant assembly may allow for easy insertion and/or resistance to expulsion (see FIGS. 10-14 for additional textured surface examples (which examples are intended to be illustrative and not restrictive)).
  • [0071]
    In another embodiment, multiple lateral spacer type components may be assembled in a “bridge” configuration (see FIGS. 15 and 16, for example).
  • [0072]
    In another embodiment, the components may be assembled as desired (see FIGS. 17A-17G, 18, 19A, 19B, 20A, 20B, 21 and 22A-22E, for example).
  • [0073]
    Referring now to FIG. 23, another embodiment of a vertebral body replacement implant assembly according to the present invention is shown. As seen in this FIG. 23, Implant Assembly 2301 may be implanted between First Vertebra 2303 a and Second Vertebra 2303 b (FIG. 24 shows another view of Implant Assembly 2301 as it would look outside of the body). Of note, Implant Assembly 2301 may be formed of a number of components fitted together.
  • [0074]
    More particularly, as seen in FIG. 25, Implant Assembly 2301 may be formed of, for example, four components: (a) First Endplate 2501 (e.g., a top Endplate), Second Endplate 2503 (e.g., a bottom Endplate), First Lateral Spacer 2505 and Second Lateral Spacer 2507.
  • [0075]
    First Endplate 2501 may include: First Offset Aperture 2501 a (e.g., offset relative to a centerline of Endplate 2501); Second Offset Aperture 2501 b (e.g., offset relative to a centerline of Endplate 2501); Protrusions 2501 c and 2501 d (these Protrusions are not seen in this Fig. but are similar to the Protrusions of Second Endplate 2503 discussed below—although in this embodiment there are four such Protrusions (two adjacent First Offset Aperture 2501 a and two adjacent Second Offset Aperture 2501 b) any number of protrusions may be utilized); Insertion Tool Mating Aperture 2501 e (for mating with an insertion tool (not shown)); and various grooves disposed along the top surface (the grooves are not separately numbered in the Figs.).
  • [0076]
    Likewise, Second Endplate 2503 may include: First Offset Aperture 2503 a (e.g., offset relative to a centerline of Endplate 2503); Second Offset Aperture 2503 b (e.g., offset relative to a centerline of Endplate 2503); Protrusions 2503 c-2503 f; Insertion Tool Mating Aperture 2503 g (for mating with an insertion tool (not shown)); and various grooves disposed along the bottom surface (the grooves are not separately numbered in the Figs.).
  • [0077]
    Further, First Lateral Spacer 2505 may include: Main Aperture 2505 a (which may at least partially line-up with First Offset Aperture 2501 b and First Offset Aperture 2503 b; various Auxiliary Apertures (not separately numbered in the Figs.); and various grooves disposed along the top surface and the bottom surface (the grooves are not separately numbered in the Figs.).
  • [0078]
    Likewise, Second Lateral Spacer 2507 may include: Main Aperture 2507 a (which may at least partially line-up with Second Offset Aperture 2501 a and Second Offset Aperture 2503 a; various Auxiliary Apertures (not separately numbered in the Figs.); and various grooves disposed along the top surface and the bottom surface (the grooves are not separately numbered in the Figs.).
  • [0079]
    Of note, the embodiments of FIGS. 25 and 3A/3B are similar, with the main differences being that in the embodiment of FIG. 25 each of First Endplate 2501 and Second Endplate 2503 includes pockets into which each of First Lateral Spacer 2505 and Second Lateral Spacer 2507 fits (Pockets 2503 h and 2503 i are individually identified in FIG. 25 in connection with Second Endplate 2503—First Endplate 2501 has similar pockets which are not seen in this view).
  • [0080]
    In one example (which example is intended to be illustrative and not restrictive), the pockets may provide (either alone or in combination with the protrusions) lateral alignment/support of the components. In another example (which example is intended to be illustrative and not restrictive), the pockets may provide (either alone or in combination with the protrusions) both lateral alignment/support of the components as well as up-down locking (e.g., removable locking) of the components. In another example (which example is intended to be illustrative and not restrictive), a tab and slot system may be utilized for locking.
  • [0081]
    Of further note, Implant Assembly 2301 may provide for bony ingrowth and/or may be packed with bone matter. This may be accomplished via the hollow fenestrated design of the components (e.g., via First Offset Aperture 2501 a; Second Offset Aperture 2501 b; First Offset Aperture 2503 a; Second Offset Aperture 2503 b; Main Aperture 2505 a; Main Aperture 2507 a; and/or the various Auxiliary Apertures) and/or the hollow fenestrated design of the finished implant assembly (e.g., via the space(s) between First Lateral Spacer 2505 and Second Lateral Spacer 2507 at each end of the finished implant assembly).
  • [0082]
    Referring now to FIGS. 26-28, it is noted that these Figs. show, respectively, a perspective view of an endplate according to an embodiment of the present invention, a perspective view of a non-lordotic lateral spacer according to an embodiment of the present invention and a perspective view of a lordotic lateral spacer according to an embodiment of the present invention.
  • [0083]
    Referring now to construction of the implant assembly it is noted, as discussed above, that the lateral spacers may be snapped onto a first endplate and then a second endplate may be snapped onto the two lateral spacers. Such snapping construction may be carried out, for example, using a lip and undercut arrangement (see FIG. 29 (showing a plan view of an implant assembly according to an embodiment of the present invention), FIG. 30 (showing section B-B of FIG. 29), and FIG. 31 (showing Detail C of FIG. 30)). More particularly, with regard to such snapping construction, attention is directed to the features of FIG. 31 which show the undercut in the lateral spacer and the tapered lip on the endplate (wherein an interference may exist in the assembly until the tapered lip reaches the undercut and snaps into place creating a lock).
  • [0084]
    While a number of embodiments of the present invention have been described, it is understood that these embodiments are illustrative only, and not restrictive, and that many modifications may become apparent to those of ordinary skill in the art. For example, an implant assembly according to the present invention may be tested in accordance with ASTM F 2077-03 “Test Methods For Intervertebral Body Fusion Devices” (or a modified version thereof) and/or the FDA's Sep. 27, 2000 “Guidance for Spinal Systems 510(k)'s. Further, the lordotic angle may be any desired angle (e.g., 4°-8°). Further still, one or more components may be used separately from an implant assembly (e.g., one or more of the lateral spacers (non-lordotic and/or lordotic) may be implanted directly into the spine without use of a top and/or bottom endplate). Further still, the various components may take different shapes as desired and the various features may take on various specifics as desired (e.g., the various apertures may be of any desired number and/or shape). Further still, the apparatus (and/or its components) may, of course, have any desired dimensions (e.g., for any desired patient—man, woman or child). Further still, the apparatus (and/or its components) may be provided in a “line” or “family” of devices (e.g., small, medium and large; adult, child; male, female). Further still, the apparatus (and/or its components) may be provided in standard sizes. Further still, any desired locking mechanism(s) may be used to hold the various components together and/or in desired alignment. Further still, such locking may be capable of being unlocked (e.g., a mechanism and/or tool may be provided for unlocking the various components). Further still, lateral spacers(s) may be disposed adjacent one or more central spacers. Further still, any steps relating to manufacture and/or use may be performed in any desired order.
Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US4892545 *Jul 14, 1988Jan 9, 1990Ohio Medical Instrument Company, Inc.Vertebral lock
US5192327 *Mar 22, 1991Mar 9, 1993Brantigan John WSurgical prosthetic implant for vertebrae
US5360430 *Jul 29, 1993Nov 1, 1994Lin Chih IIntervertebral locking device
US5397364 *Oct 12, 1993Mar 14, 1995Danek Medical, Inc.Anterior interbody fusion device
US5458641 *Sep 8, 1993Oct 17, 1995Ramirez Jimenez; Juan J.Vertebral body prosthesis
US5916267 *Apr 7, 1997Jun 29, 1999Arthit SitisoAnterior spinal implant system for vertebral body prosthesis
US6039761 *Feb 12, 1997Mar 21, 2000Li Medical Technologies, Inc.Intervertebral spacer and tool and method for emplacement thereof
US6159211 *Oct 22, 1998Dec 12, 2000Depuy Acromed, Inc.Stackable cage system for corpectomy/vertebrectomy
US6395030 *Apr 27, 2000May 28, 2002Michigan Technological UniversitySpinal fixation system
US6409766 *Aug 9, 2000Jun 25, 2002Expanding Concepts, LlcCollapsible and expandable interbody fusion device
US6432107 *Jan 15, 2000Aug 13, 2002Bret A. FerreeEnhanced surface area spinal fusion devices
US6447544 *Oct 4, 1999Sep 10, 2002Gary Karlin MichelsonLordotic interbody spinal fusion implants
US6468311 *Jan 22, 2001Oct 22, 2002Sdgi Holdings, Inc.Modular interbody fusion implant
US6475219 *Jun 7, 2001Nov 5, 2002Alexis P. ShelokovAnterior vertebral protection method and device
US6500205 *Apr 19, 2000Dec 31, 2002Gary K. MichelsonExpandable threaded arcuate interbody spinal fusion implant with cylindrical configuration during insertion
US6562074 *Apr 12, 2002May 13, 2003Medicinelodge, Inc.Adjustable bone fusion implant and method
US6579290 *Nov 27, 1998Jun 17, 2003Surgicraft LimitedSurgical implant and surgical fixing screw
US6613051 *Nov 17, 2000Sep 2, 2003The University Of Hong KongAnterior transpedicular fixation system and method for maintaining a vertebral column
US6682561 *Mar 25, 2002Jan 27, 2004Pioneer Laboratories, Inc.Spinal fixation system
US6723126 *Nov 1, 2002Apr 20, 2004Sdgi Holdings, Inc.Laterally expandable cage
US6852129 *Mar 5, 2003Feb 8, 2005Movdice Holding, Inc.Adjustable bone fusion implant and method
US20020052656 *Dec 11, 2001May 2, 2002Michelson Gary KarlinExpandable push-in interbody spinal fusion implant
US20020077702 *Nov 21, 2001Jun 20, 2002Cortek, Inc.Dynamic implanted intervertebral spacer
US20020091446 *Oct 26, 2001Jul 11, 2002Zucherman James F.Interspinous process distraction system and method with positionable wing and method
US20020128652 *May 14, 2002Sep 12, 2002Ferree Bret A.Version with markings to show changes made
US20020128715 *Aug 8, 2001Sep 12, 2002Vincent BryanImplantable joint prosthesis
US20020169508 *Mar 25, 2002Nov 14, 2002Pioneer Laboratories, Inc.Spinal fixation system
US20030023312 *Sep 27, 2002Jan 30, 2003Thalgott John S.Disc prosthesis
US20030040799 *Oct 16, 2002Feb 27, 2003Boyd Lawrence M.Modular interbody fusion implant
US20030045940 *Aug 23, 2002Mar 6, 2003Robert EberleinArtificial intervertebral disc
US20030100950 *Mar 21, 2001May 29, 2003Olivier MoretCage-type intervertebral implant
US20030125739 *Sep 26, 2002Jul 3, 2003Bagga Charanpreet S.Bioactive spinal implants and method of manufacture thereof
US20030171813 *Mar 5, 2002Sep 11, 2003P. Douglas KiesterMethod and apparatus for providing an expandable spinal fusion cage
US20040030387 *Mar 11, 2003Feb 12, 2004Landry Michael E.Instrumentation and procedure for implanting spinal implant devices
US20040068318 *Oct 2, 2002Apr 8, 2004Coates Bradley J.Modular intervertebral prosthesis system
US20040073314 *Mar 21, 2003Apr 15, 2004White John L.Vertebral body and disc space replacement devices
US20050060034 *Sep 15, 2003Mar 17, 2005Sdgi Holdings, Inc.Revisable prosthetic device
US20050060036 *Jul 6, 2004Mar 17, 2005Robert SchultzSpinal column implant
US20060058877 *Jun 6, 2005Mar 16, 2006Michael GutlinIntervertebral implant
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US7690381 *Apr 6, 2010Depuy Spine, Inc.Intervertebral prosthetic disc and method for installing using a guidewire
US7811326Oct 12, 2010Warsaw Orthopedic Inc.Posterior joint replacement device
US7875075Sep 26, 2006Jan 25, 2011Warsaw Orthopedic, Inc.Hybrid intervertebral spinal fusion implant
US7976549Mar 23, 2007Jul 12, 2011Theken Spine, LlcInstruments for delivering spinal implants
US7988695Aug 2, 2011Theken Spine, LlcArticulated delivery instrument
US7998212 *Sep 26, 2006Aug 16, 2011Warsaw Orthopedic, Inc.Transforaminal hybrid implant
US8372150Aug 2, 2010Feb 12, 2013Warsaw Orthpedic, Inc.Spinal device and method
US8500778 *Jan 31, 2007Aug 6, 2013DePuy Synthes Products, LLCInterspinous process spacer
US8506636Jun 25, 2007Aug 13, 2013Theken Spine, LlcOffset radius lordosis
US8574301 *Jan 24, 2013Nov 5, 2013Nuvasive, Inc.Systems and methods for spinal fusion
US8608804 *Jan 23, 2013Dec 17, 2013Nuvasive, Inc.Systems and methods for spinal fusion
US8728166Jan 14, 2011May 20, 2014Warsaw Orthopedic, Inc.Hybrid intervertebral spinal fusion implant
US8764832 *Sep 26, 2006Jul 1, 2014Warsaw Orhtopedic, Inc.Anterior hybrid implant
US8814940 *Feb 3, 2014Aug 26, 2014Nuvasive, Inc.Systems and methods for spinal fusion
US8864832Aug 16, 2007Oct 21, 2014Hh Spinal LlcPosterior total joint replacement
US8888852Jun 15, 2009Nov 18, 2014Hh Spinal LlcSpinal athroplasty device and method
US8906099 *Jul 6, 2012Dec 9, 2014Nicholas PoulosExpandable interbody implant and method
US8945226 *Dec 31, 2009Feb 3, 2015RhauslerVertebral spacer
US9168152Dec 27, 2011Oct 27, 2015Nuvasive, Inc.Implants and methods for spinal fusion
US9180017 *Oct 7, 2010Nov 10, 2015Nicholas PoulosLumbar implant
US9180021Jun 25, 2014Nov 10, 2015Nuvasive, Inc.Systems and methods for spinal fusion
US9186261Feb 28, 2014Nov 17, 2015Nuvasive, Inc.System and methods for spinal fusion
US9198765Oct 31, 2012Dec 1, 2015Nuvasive, Inc.Expandable spinal fusion implants and related methods
US9211193Aug 30, 2013Dec 15, 2015Aesculap Implant Systems, LlcProsthesis, system and method
US9211195Oct 22, 2014Dec 15, 2015Nicholas PoulosExpandable interbody implant and method
US9326861Aug 3, 2012May 3, 2016Globus Medical, Inc.Stabilizing joints
US9358127Feb 1, 2012Jun 7, 2016Globus Medical, Inc.Intervertebral fusion implant
US9364340Sep 1, 2015Jun 14, 2016Globus Medical, Inc.Low profile plate
US9364343Dec 26, 2013Jun 14, 2016Globus Medical, Inc.Intervertebral fusion implant
US20050171608 *Jan 7, 2005Aug 4, 2005Sdgi Holdings, Inc.Centrally articulating spinal device and method
US20060178746 *Feb 10, 2005Aug 10, 2006Depuy Spine, Inc.Intervertebral prosthetic disc and method for installing using a guidewire
US20070093898 *Sep 26, 2006Apr 26, 2007Schwab Frank JTransforaminal hybrid implant
US20070233247 *Sep 26, 2006Oct 4, 2007Schwab Frank JHybrid intervertebral spinal fusion implant
US20070233248 *Sep 26, 2006Oct 4, 2007Schwab Frank JAnterior hybrid implant
US20070239278 *Apr 6, 2006Oct 11, 2007Sdgi Holdings, Inc.Intervertebral prosthetic devices and methods
US20080140204 *Dec 7, 2006Jun 12, 2008Warsaw Orthopedic, Inc.Vertebral Implant Systems and Methods of Use
US20090306715 *Jan 31, 2007Dec 10, 2009Jackson Benjamin LInterspinous process spacer
US20110087329 *Apr 14, 2011Nicholas PoulosLumbar implant
US20110112643 *May 12, 2011Schwab Frank JHybrid Intervertebral Spinal Fusion Implant
US20110160860 *Dec 31, 2009Jun 30, 2011Rhausler, Inc.Cervical spacer
US20130178939 *Jul 6, 2012Jul 11, 2013Nicholas PoulosExpandable interbody implant and method
US20140100663 *Dec 10, 2013Apr 10, 2014DePuy Synthes Products, LLCIntervertebral implant with fixation geometry
US20140257492 *May 21, 2014Sep 11, 2014Warsaw Orthopedic, Inc.Anterior hybrid implant
USD754346Jan 20, 2014Apr 19, 2016Nuvasive, Inc.Spinal fusion implant
WO2008065450A1Nov 29, 2007Jun 5, 2008Surgicraft LimitedOrthopaedic implants and prostheses
Legal Events
DateCodeEventDescription
Apr 29, 2005ASAssignment
Owner name: BLACKSTONE MEDICAL, INC., MASSACHUSETTS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:WOLEK, HOWARD;LAROSA, FRANCESCO;KOZAK, M.D., DR. JEFFREYA.;AND OTHERS;REEL/FRAME:015964/0015;SIGNING DATES FROM 20050124 TO 20050425
Oct 9, 2006ASAssignment
Owner name: WACHOVIA BANK, NATIONAL ASSOCIATION, AS ADMINISTRA
Free format text: NOTICE OF GRANT OF SECURITY INTEREST;ASSIGNOR:BLACKSTONE MEDICAL, INC.;REEL/FRAME:018362/0582
Effective date: 20060922
Oct 18, 2010ASAssignment
Owner name: BLACKSTONE MEDICAL, INC., TEXAS
Free format text: TERMINATION OF SECURITY INTEREST IN PATENTS;ASSIGNOR:WELLS FARGO BANK, NATIONAL ASSOCIATION, SUCCESSOR-BY-MERGER TO WACHOVIA BANK, NATIONAL ASSOCIATION, AS ADMINISTRATIVE AGENT;REEL/FRAME:025150/0583
Effective date: 20100827