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Número de publicaciónUS20050015093 A1
Tipo de publicaciónSolicitud
Número de solicitudUS 10/837,085
Fecha de publicación20 Ene 2005
Fecha de presentación30 Abr 2004
Fecha de prioridad16 Jul 2003
También publicado comoCA2532747A1, CN1909849A, DE602004031429D1, EP1651122A2, EP1651122A4, EP1651122B1, US7731721, US20050015092, WO2005009487A2, WO2005009487A3
Número de publicación10837085, 837085, US 2005/0015093 A1, US 2005/015093 A1, US 20050015093 A1, US 20050015093A1, US 2005015093 A1, US 2005015093A1, US-A1-20050015093, US-A1-2005015093, US2005/0015093A1, US2005/015093A1, US20050015093 A1, US20050015093A1, US2005015093 A1, US2005015093A1
InventoresSean Suh, David Rathbun, Christoph Roth, Lan Anh Duong, Lawrence Binder, Christopher Ryan, Pascal Stihl
Cesionario originalSuh Sean S., Rathbun David S., Roth Christoph Andreas, Duong Lan Anh N., Binder Lawrence J., Ryan Christopher J., Pascal Stihl
Exportar citaBiBTeX, EndNote, RefMan
Enlaces externos: USPTO, Cesión de USPTO, Espacenet
Plating system with compression drill guide
US 20050015093 A1
Resumen
A drill guide, drill guide system and method of use is disclosed. The drill guide assembly includes one or more alignment drill tubes that are remotely alignable with corresponding fastener holes of a bone plate to which the drill guide is releasably lockable. The drill guide is configured to allow a bone hole to be drilled slightly off-center with respect to the fastener holes of the plate so that fasteners inserted in those holes may be used to compress the underlying bone segments together when the fasteners are tightened in the bone and plate. In one embodiment, the drill guide is disclosed for use in compressing and fixing adjacent vertebra as part of a spinal fusion procedure.
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Reclamaciones(55)
1. A surgical drill guide assembly comprising:
a stem member releasably engageable with the guide engaging hole of the bone plate;
at least one guide barrel associated with the stem member and configured to receive a tool, the guide barrel having a longitudinal axis; and
a bone plate having at least one fixation hole configured to receive a fastener to fix the plate to a bone, and at least one guide engaging hole for engaging the drill guide;
wherein the stem member and guide barrel are configured so that when the stem member engages the bone plate the guide barrel longitudinal axis is oriented non-coaxial with the fixation hole.
2. The surgical drill guide assembly of claim 1, where the tool is a drill bit.
3. The surgical drill guide assembly of claim 1, where the tool is an awl, a probe or a tap.
4. The surgical drill guide assembly of claim 1, the fixation hole further having a center point, wherein when the stem member engages the bone plate the guide barrel longitudinal axis does not intersect with the center point of the fixation hole.
5. The surgical drill guide assembly of claim 1, the bone plate further having a longitudinal axis, the tool configured for forming a hole in bone, wherein when the tool is received within the guide barrel and engaged with bone to form a hole, the center of the hole is located a first distance from the center of the corresponding plate fixation hole.
6. The surgical drill guide assembly of claim 5, wherein the first distance is from about 0.1 millimeters (mm) to about 0.8 mm as measured along a line substantially parallel to the plate longitudinal axis.
7. The surgical drill guide assembly of claim 5, wherein the first distance is about 0.5 mm as measured along a line substantially parallel to the plate longitudinal axis.
8. The surgical drill guide assembly of claim 5, wherein when the stem member engages the guide engaging hole of the bone plate, the guide barrel does not contact the plate.
9. The surgical drill guide assembly of claim 1, wherein at least a portion of the stem member and the guide engaging hole of the bone plate comprise corresponding threads to allow the stem to be threadably engaged with the plate.
10. The surgical drill guide assembly of claim 1, wherein the guide barrel is connected to the stem member via a hinge, the hinge allowing the guide barrel to be pivoted about the stem with respect to the plate so that when the stem is engaged with the guide engaging hole of the bone plate, the guide barrel is selectively alignable with at least two fixation holes of the bone plate to allow the tool to be inserted through the guide barrel to form a hole in bone through each fixation hole without disengaging the stem from the plate.
11. The surgical drill guide assembly of claim 1, further comprising a second drill guide barrel.
12. The surgical drill guide assembly of claim 1, wherein the drill guide barrel comprises first and second tool receiving recesses.
13. The surgical drill guide assembly of claim 12, wherein each tool receiving recess has a longitudinal axis, the two axes being non-parallel.
14. The surgical drill guide assembly of claim 12, wherein the longitudinal axes of the tool receiving recesses converge at a point located a first distance from the center of the plate hole.
15. A method of installing a bone plate on at least two vertebrae, comprising the steps of:
(a) providing a bone plate having at least one fastener hole configured to receive a bone fastener for fixing the plate to a vertebra;
(b) providing a drill guide having a stem member and a guide barrel, the stem member configured to engage a bone plate and the guide barrel configured to receive a tool for forming a hole in bone;
(c) engaging the stem member with the bone plate so that the guide barrel is located adjacent to the at least one fastener hole;
(d) placing the bone plate on vertebrae so that the at least one fastener hole lies adjacent a vertebra; and
(e) passing the tool through the guide barrel and the fastener hole so that the tool engages the vertebra and cuts a hole in the bone underlying the fastener hole;
wherein the hole in the bone is located a first distance from the center of the fastener hole.
16. The method of claim 15, wherein the first distance is from about 0.1 mm to about 0.8 mm.
17. The method of claim 15, wherein the first distance is about 0.5 mm.
18. The method of claim 15, wherein the tool is a drill bit.
19. The method of claim 15, where the tool is an awl, a probe or a tap.
20. The method of claim 15, further comprising the steps of
(f) inserting a bone screw into the hole in the bone; and
(g) tightening the screw in the hole, the screw having a head and an underside surface;
wherein the underside surface of the screw head engages an inner side surface of the fastener hole so that the screw and plate are moved longitudinally with respect to each other as the screw is screwed into the bone.
21. The method of claim 15, wherein the stem and guide barrel are configured so that the screw and plate are moved longitudinally with respect to each other by a second distance as the screw is screwed in the bone.
22. The method of claim 21, wherein the first and second distances are substantially equal.
23. The method of claim 21, wherein the second distance is about 0.5 mm.
24. The method of claim 21, wherein when the screw and plate are moved longitudinally, the associated vertebra are moved longitudinally.
25. The method of claim 24, wherein the longitudinal movement of the screw applies a force on the associated vertebra tending to compress the disc space located between the vertebra.
26. The method of claim 15, the bone plate further comprising a second fastener hole, the drill guide having a second guide barrel configured to receive a tool for forming a hole in bone adjacent the second fastener hole.
27. The method of claim 26, wherein the first and second guide barrels each has first and second tool receiving recesses, the recesses each having a trajectory, the trajectories of the first and second recesses being substantially non-parallel.
28. The method of claim 15, the bone plate further comprising a second fastener hole, the guide barrel being attached to the stem member via a pivot joint, the barrel being movable about the pivot joint to move from a first position adjacent the first fastener hole of the bone plate to a second position adjacent the second fastener hole of the bone plate.
29. The method of claim 28, the guide barrel further having an internal shoulder configured to engage a portion of the tool inserted therethrough to limit the depth of penetration of the tool into the underlying bone to a predetermined amount.
30. The method of claim 29, the guide barrel further having at least one longitudinal slot running along a substantial portion of a length of the guide barrel, the slot configured to allow the user to visualize the position of the tool within the guide barrel.
31. The method of claim 30, further comprising a handle associated with the stem, the handle being pivotably adjustable with respect to the stem to allow the handle to be rotated to a desired position relative to the guide barrel.
32. The method of claim 31, wherein the handle has a longitudinal axis that is substantially non-parallel to the longitudinal axis of the guide barrel.
33. A drill guide kit, comprising:
a first drill guide assembly comprising a first plate-engaging stem and a first guide barrel configured to receive a tool, the first guide barrel having a longitudinal axis, the stem releasably engageable with a bone plate to position the first guide barrel adjacent a first fastener hole of the bone plate;
a second drill guide assembly comprising a second plate engaging stem and a second guide barrel configured to receive a tool, the second guide barrel having a longitudinal axis, the stem releasably engageable with the bone plate to position the second guide barrel adjacent a second fastener hole of the bone plate;
wherein the first stem and first guide barrel are configured so that when the stem member engages the bone plate the guide barrel longitudinal axis intersects the center of the fastener hole, and the second stem and second guide barrel are configured so that when the second stem member engages the bone plate the second guide barrel is substantially aligned with the fixation hole but the longitudinal axis does not intersect the center of the fixation hole.
34. The drill guide kit of claim 33, further comprising a bone plate having at least one fixation hole and a longitudinal axis, the second guide barrel configured to receive a tool for forming a hole in bone through the fixation hole, the center of the bone hole being located a first distance from the center of the fixation hole as measured along an axis parallel to the longitudinal axis of the plate.
35. The drill guide kit of claim 34, wherein the tool is a drill bit.
36. The drill guide kit of claim 34, where the tool is one of an awl, a probe or a tap.
37. The drill guide kit of claim 34, the first guide barrel configured to receive a tool for forming a hole in bone through the fixation hole, the center of the bone hole being collinear with the center of the fixation hole as measured along an axis parallel to the longitudinal axis of the bone plate.
38. The drill guide kit of claim 34, wherein the first distance being in the range of from about 0.1 mm to about 0.8 mm.
39. The drill guide kit of claim 34, wherein the first distance is about 0.5 mm.
40. The drill guide kit of claim 34, wherein when the stem of at least one of the first or second drill guide assemblies engages the bone plate, the associated guide barrel does not contact the plate.
41. The drill guide kit of claim 40, wherein the guide barrel of at least one of the first or second drill guide assemblies has a viewing recess configured to allow the user to visualize at least a portion of the tool as it is passed through the associated guide barrel.
42. The drill guide kit of claim 33, wherein the stem of at least one of the first or second drill guide assemblies has threads configured to engage corresponding threads in the plate.
43. The drill guide kit of claim 33, wherein the guide barrel of at least one of the first and second drill guide assemblies is connected to the associated stem member via a hinge, the hinge allowing the guide barrel to be pivoted about the stem with respect to the plate so that when the stem is engaged with the plate, the guide barrel is selectively alignable with at least two fixation holes of the bone plate to allow a drill bit inserted through the guide barrel to be used to drill holes in bone through each fixation hole without disengaging the stem from the plate.
44. The drill guide kit of claim 33, at least one of the first and second drill guide assemblies further comprising an additional guide barrel configured to receive a tool for forming a hole in bone.
45. The drill guide kit of claim 44, the plate further comprising a second fixation hole, wherein when the stem of the drill guide assembly is engaged with the plate the guide barrels are substantially aligned with at least a portion of the first and second fixation holes.
46. A surgical system comprising:
a bone plate having first and second ends, a longitudinal axis, and at least one fixation hole disposed at each of the first and second ends, the fixation holes configured to receive a fastener to fix the plate to a bone, the bone plate further comprising at least one guide engaging hole for engaging the drill guide;
a drill guide comprising a stem member releasably engageable with the guide engaging hole of the bone plate, and a guide barrel associated with the stem member and configured to receive a tool, the guide barrel having a longitudinal axis;
wherein the guide barrel is configured so that when the stem member engages the bone plate the guide barrel longitudinal axis does not intersect the center of the fixation hole.
47. The surgical system of claim 46, the tool further configured to form a hole in bone, wherein when the tool is received within the guide barrel and engages bone to form a hole, the hole is collinear with the longitudinal axis of the guide barrel.
48. The surgical system of claim 47, wherein the tool is a drill bit.
49. The surgical system of claim 47, where the tool is one of an awl, a probe or a tap.
50. The surgical system of claim 46, further comprising a plurality of bone fasteners, each fastener having a head portion with an underside surface configured to engage a portion of a corresponding fixation hole.
51. The surgical system of claim 50, wherein when the bone plate is placed over first and second bone segments so that the fixation hole in the first end of the plate overlies the first bone segment and the fixation hole in the second end of the plate overlies the second bone segment, the drill guide is selectively engageable with the plate to drill a hole in the bone through at least one fixation hole.
52. The surgical system of claim 51, wherein when the plate is fixed to the first bone segment using a fastener inserted into the fixation hole at the first end of the plate, the drill guide is engageable with the plate to allow a hole to be formed in the bone underlying the fixation hole at the second end of the plate so that a fastener inserted into the hole will contact a portion of the fixation hole.
53. The surgical system of claim 52, wherein the underside surface of the fastener head portion engages a side portion of the fixation hole before the fastener is fully seated in the fixation hole.
54. The surgical system of claim, 53, wherein when the fastener head portion engages the side portion of the fastener hole, further tightening of the fastener causes the fastener to move longitudinally along a longitudinal axis of the plate.
55. The surgical system of claim 54, wherein the further tightening of the fastener causes the first bone segment to move relative to the second bone segment.
Descripción
    CROSS REFERENCE TO RELATED APPLICATION
  • [0001]
    This application is a continuation-in-part of U.S. Non-Provisional patent application Ser. No. 10/619,472, filed Jul. 16, 2003, titled “Anterior Plating System and Drill Guides,” the entire contents of which is incorporated herein by reference.
  • FIELD OF THE INVENTION
  • [0002]
    The present invention relates to a bone fixation system including a plate and surgical drill guide that are releasably attachable to each other for providing a precise alignment therebetween. More particularly, the present invention relates to a bone plate having fastener holes oriented at predetermined angles with respect to the plate and a plate holder and surgical drill guide assembly with at least one alignment drill guiding barrel that is aligned with the respective fastener holes in a bone plate for drilling the holes at the proper angle.
  • BACKGROUND OF THE INVENTION
  • [0003]
    The use of surgical fixation plates for a variety of orthopedic applications is widely accepted. The plates are used by surgeons to mend, align, and alter compression of patient's bones, and are typically fastened to the bones with a plurality of fasteners such as screws that are installed through holes in the plate. Proper orientation and alignment of fasteners and secure surgical fixation of the plates is advantageous in avoiding future complications after implantation.
  • [0004]
    Bone plates used in spinal applications must be installed with special care, as the plates are used for long term, intervertebral fixation, bone-fragment fixation, and anterior decompression in the cervical region of the spine. The margin for error in spinal surgery is quite small, particularly because of the sensitivity of the spinal cord and the risk inherent with invasive procedures around the spinal cord. In particular, the dimensions of vertebral bone available for setting fasteners are fairly limiting.
  • [0005]
    Each fixation fastener should properly align with its associated plate hole so that each screw is seated correctly with the plate and enters the bone at an appropriate angle. Any misalignment of the screw within the plate hole risks tissue damage. In addition, improperly seated screws may result in an unstable or insecure connection of the plate to the bony material, thus potentially defeating the usefulness of the plate. Locking plates, in particular, demand precise fastener alignment.
  • SUMMARY OF THE INVENTION
  • [0006]
    The invention relates to a bone plate, a surgical drill guide assembly comprising at least one alignment drill tube configured to receive and guide a surgical drill bit; and a plate holder that couples to the plate and to the drill guide assembly. The drill guide assembly is configured and dimensioned to allow it to couple with the plate holder and plate to provide a fixed dimensional and angular alignment between the alignment drill tube and the bone plate.
  • [0007]
    The bone plate has two or more pairs of fixation holes and may have one or more slots along the central longitudinal axis of the plate. The fixation holes are preferably conical and preferably threaded. The bone screws to be used with the bone plate preferably have threaded or unthreaded conical heads to match the fixation holes in the bone plate. The fixation holes in the bone plate may be angled toward the central axis of the bone plate up to about 10°, and may also be angled up to about 15° upward or downward along the direction of the longitudinal axis of the bone plate which is generally aligned in the direction of the length of the spine. The slot(s) may be threaded or have a counterbore at its ends to allow coupling of the drill guide assembly or the plate holder. The bone plate may have any thickness, and its thickness may vary along its length and width; although 2.2 mm is an exemplary thickness. The plate may also have a step feature or flange to facilitate placing the plate on the sacral promontory.
  • [0008]
    The plate holder may include a rod having a circular cross section along with a short threaded section for coupling with a threaded hole in the plate, a short non-circular section, such as, for example, a hexagonal section on the end opposite from the threaded end, and a radial groove between the ends. The plate holder attaches to the plate and allows the user to manipulate the plate from a location remote from and without touching the plate.
  • [0009]
    Preferably, the drill guide assembly includes a handle member, an offset handle stem, an outer stem, a release sleeve on the outer stem, captive ball detents in the wall of the outer stem to engage the radial groove of the plate holder rod, and a release sleeve spring that biases the release sleeve axially away from the end of the outer stem opposite the bone plate. The release sleeve is preferably captively attached to the outer stem such that it may rotate about the outer stem and has limited axial movement with respect to the outer stem. Pressing the release sleeve against the bias of the spring allows radial movement of the captive ball detents in the wall of the outer stem due to a tapered inner surface of the release sleeve or a section of the release sleeve with an increased inner diameter.
  • [0010]
    Coupling of the drill guide assembly to the plate holder is accomplished by sliding the outer stem of the drill guide assembly over the plate holder and aligning the non-circular end of the plate holder with a matching non-circular hole at the end of the outer stem of the drill guide assembly. The captive ball detents engage the radial groove of the plate holder and lock the drill guide assembly to the plate holder when the release sleeve is allowed to return to its spring-biased position. The release sleeve may have a non-circular hole the perimeter of which engages the perimeter of the matching non-circular end of the plate holder. The release sleeve can be rotated in relation to the outer stem to allow screwing and unscrewing of the plate holder from the bone plate while the remainder of the drill guide assembly remains stationary. Although the connection between the drill guide assembly and the plate holder has been described as a stem coaxial with and sliding over a rod, other embodiments are possible including, for example, a drill guide assembly with a stem attaching to the side of a plate holder.
  • [0011]
    The drill guide assembly may include either one or two guiding barrels to allow passage of fixation pins or bone screws, drills, taps, and awls through it in a predetermined trajectory. The guiding barrels may have more than one insertion location with variable or pre-determined trajectories offset from a single exit location. The guiding barrels of the single barrel embodiments of the drill guide may be movable by means of a pivoting mechanism to allow drilling holes into bone on both sides of the longitudinal axis of the bone plate. The guiding barrels of the double barrel embodiments of the drill guide assembly also preferably have a tab to engage a slot of the bone plate to prevent rotation of the drill guide assembly in relation to the bone plate. The single barrel embodiments of the drill guide assembly also preferably have a tab on the outer stem to engage a slot of the bone plate to prevent rotation of the drill guide assembly in relation to the bone plate.
  • [0012]
    The handle of the drill guide assembly may have a ratchet gear mechanism that permits incremental swiveling with respect to the axis of a button cam. The ratchet is operated by pressing and holding a button cam while turning the handle. The handle may lock at predetermined angle intervals.
  • [0013]
    A surgical drill guide assembly may be provided, the assembly comprising a stem member releasably engageable with the guide engaging hole of the bone plate; at least one guide barrel associated with the stem member and configured to receive a tool, the guide barrel having a longitudinal axis; and a bone plate having at least one fixation hole configured to receive a fastener to fix the plate to a bone, and at least one guide engaging hole for engaging the drill guide. The stem member and guide barrel may be configured so that when the stem member engages the bone plate the guide barrel longitudinal axis is oriented non-coaxial with the fixation hole. The tool may be a drill bit, an awl, a probe or a tap.
  • [0014]
    The fixation hole may also have a center point, wherein when the stem member engages the bone plate the guide barrel longitudinal axis does not intersect with the center point of the fixation hole. The bone plate further may have a longitudinal axis and the tool may be configured for forming a hole in bone. When the tool is received within the guide barrel and engaged with bone to form a hole, the center of the hole may be located a first distance from the center of the corresponding plate fixation hole. The first distance may be from about 0.1 millimeters (mm) to about 0.8 mm as measured along a line substantially parallel to the plate longitudinal axis. The first distance may be about 0.5 mm as measured along a line substantially parallel to the plate longitudinal axis.
  • [0015]
    When the stem member engages the guide engaging hole of the bone plate, the guide barrel may not contact the plate. At least a portion of the stem member and the guide engaging hole of the bone plate may comprise corresponding threads to allow the stem to be threadably engaged with the plate. The guide barrel may be connected to the stem member via a hinge, the hinge allowing the guide barrel to be pivoted about the stem with respect to the plate so that when the stem is engaged with the guide engaging hole of the bone plate, the guide barrel is selectively alignable with at least two fixation holes of the bone plate to allow the tool to be inserted through the guide barrel to form a hole in bone through each fixation hole without disengaging the stem from the plate.
  • [0016]
    The surgical drill guide assembly may further comprise a second drill guide barrel. The drill guide barrel may comprise first and second tool receiving recesses. Each tool receiving recess may have a longitudinal axis, and the two axes may be non-parallel. The longitudinal axes of the tool receiving recesses may converge at a point located a first distance from the center of the plate hole.
  • [0017]
    A method of installing a bone plate on at least two vertebrae is disclosed. The method may comprise the steps of: (a) providing a bone plate having at least one fastener hole configured to receive a bone fastener for fixing the plate to a vertebra; (b) providing a drill guide having a stem member and a guide barrel, the stem member configured to engage a bone plate and the guide barrel configured to receive a tool for forming a hole in bone; (c) engaging the stem member with the bone plate so that the guide barrel is located adjacent to the at least one fastener hole; (d) placing the bone plate on vertebrae so that the at least one fastener hole lies adjacent a vertebra; and (e)passing the tool through the guide barrel and the fastener hole so that the tool engages the vertebra and cuts a hole in the bone underlying the fastener hole; wherein the hole in the bone is located a first distance from the center of the fastener hole. The first distance may be from about 0.1 mm to about 0.8 mm, or it may be about 0.5 mm. The tool may be a drill bit, an awl, a probe or a tap.
  • [0018]
    The method may further comprise the steps of: (f) inserting a bone screw into the hole in the bone; and (g) tightening the screw in the hole, the screw having a head and an underside surface; wherein the underside surface of the screw head engages an inner side surface of the fastener hole so that the screw and plate are moved longitudinally with respect to each other as the screw is screwed into the bone.
  • [0019]
    The stem and guide barrel of the drill guide may be configured so that the screw and plate are moved longitudinally with respect to each other by a second distance as the screw is screwed into the hole in the bone. The first and second distances are substantially equal. The second distance may be about 0.5 mm. When the screw and plate are moved longitudinally, the associated vertebra may be moved longitudinally. The longitudinal movement of the screw may apply a force on the associated vertebra tending to compress the disc space located between the vertebra.
  • [0020]
    The bone plate may further comprise a second fastener hole, and the drill guide may have a second guide barrel configured to receive a tool for forming a hole in bone adjacent the second fastener hole. The first and second guide barrels may each have first and second tool receiving recesses, the recesses each having a trajectory, the trajectories of the first and second recesses being substantially non-parallel.
  • [0021]
    The bone plate may further comprise a second fastener hole, and the guide barrel may be attached to the stem member via a pivot joint. The barrel may be movable about the pivot joint to move from a first position adjacent the first fastener hole of the bone plate to a second position adjacent the second fastener hole of the bone plate.
  • [0022]
    The guide barrel may further having an internal shoulder configured to engage a portion of the tool inserted therethrough to limit the depth of penetration of the tool into the underlying bone to a predetermined amount. The guide barrel further may have at least one longitudinal slot running along a substantial portion of a length of the guide barrel, the slot configured to allow the user to visualize the position of the tool within the guide barrel. A handle may be associated with the stem, the handle being pivotably adjustable with respect to the stem to allow the handle to be rotated to a desired position relative to the guide barrel. The handle may have a longitudinal axis that is substantially non-parallel to the longitudinal axis of the guide barrel.
  • [0023]
    A drill guide kit may also be provided. The kit may comprise a first drill guide assembly comprising a first plate-engaging stem and a first guide barrel configured to receive a tool. The first guide barrel may have a longitudinal axis, and the stem may be releasably engageable with a bone plate to position the first guide barrel adjacent a first fastener hole of the bone plate. The kit may also comprise a second drill guide assembly having a second plate engaging stem and a second guide barrel configured to receive a tool, the second guide barrel having a longitudinal axis. The stem may be releasably engageable with the bone plate to position the second guide barrel adjacent a second fastener hole of the bone plate. The first stem and first guide barrel may further be configured so that when the stem member engages the bone plate the guide barrel longitudinal axis intersects the center of the fastener hole, and the second stem and second guide barrel may be configured so that when the second stem member engages the bone plate the second guide barrel is substantially aligned with the fixation hole but the longitudinal axis does not intersect the center of the fixation hole.
  • [0024]
    The drill guide kit may further comprise a bone plate having at least one fixation hole and a longitudinal axis. The second guide barrel may be configured to receive a tool for forming a hole in bone through the fixation hole, and the center of the bone hole may be located a first distance from the center of the fixation hole as measured along an axis parallel to the longitudinal axis of the plate. The first distance may be in the range of from about 0.1 mm to about 0.8 mm, and in a specific embodiment, the first distance may be about 0.5 mm.
  • [0025]
    The first guide barrel may be configured to receive a tool for forming a hole in bone through the fixation hole, the center of the bone hole being collinear with the center of the fixation hole as measured along an axis parallel to the longitudinal axis of the bone plate. The tool may be a drill bit. Alternatively, the tool may be an awl, a probe or a tap.
  • [0026]
    The first and second drill guides may be configured so that when the stem of the guide assemblies engages the bone plate, the associated guide barrel may not contact the plate. The guide barrel of at least one of the first or second drill guide assemblies may have a viewing recess configured to allow the user to visualize at least a portion of the tool as it is passed through the associated guide barrel. The stem of at least one of the first or second drill guide assemblies may have threads configured to engage corresponding threads in the plate.
  • [0027]
    The guide barrel of at least one of the first and second drill guide assemblies may be connected to the associated stem member via a hinge, the hinge allowing the guide barrel to be pivoted about the stem with respect to the plate so that when the stem is engaged with the plate, the guide barrel is selectively alignable with at least two fixation holes of the bone plate to allow a drill bit inserted through the guide barrel to be used to drill holes in bone through each fixation hole without disengaging the stem from the plate. At least one of the first and second drill guide assemblies may further comprise an additional guide barrel configured to receive a tool for forming a hole in bone.
  • [0028]
    The plate may further comprise a second fixation hole, wherein when the stem of the drill guide assembly is engaged with the plate the guide barrels are substantially aligned with at least a portion of the first and second fixation holes.
  • [0029]
    A surgical system may be provided comprising a bone plate having first and second ends, a longitudinal axis, and at least one fixation hole disposed at each of the first and second ends. The fixation holes may be configured to receive a fastener to fix the plate to a bone, and the bone plate may further comprise at least one guide engaging hole for engaging the drill guide. The system may further comprise a drill guide having a stem member releasably engageable with the guide engaging hole of the bone plate, and a guide barrel associated with the stem member and configured to receive a tool. The guide barrel may have a longitudinal axis and may further be configured so that when the stem member engages the bone plate the guide barrel longitudinal axis does not intersect the center of the fixation hole.
  • [0030]
    The tool may be configured to form a hole in bone, wherein when the tool is received within the guide barrel and engages bone to form a hole, the hole is collinear with the longitudinal axis of the guide barrel. The tool may be a drill bit. Alternatively, the tool may be of an awl, a probe or a tap. The system may further comprise a plurality of bone fasteners, each fastener having a head portion with an underside surface configured to engage a portion of a corresponding fixation hole.
  • [0031]
    The drill guide may be configured so that when the bone plate is placed over first and second bone segments so that the fixation hole in the first end of the plate overlies the first bone segment and the fixation hole in the second end of the plate overlies the second bone segment, the drill guide is selectively engageable with the plate to drill a hole in the bone through at least one fastener hole.
  • [0032]
    The drill guide may further be configured so that when the plate is fixed to the first bone segment using a fastener inserted into the fixation hole at the first end of the plate, the drill guide is engageable with the plate to allow a hole to be formed in the bone underlying the fixation hole at the second end of the plate so that a fastener inserted into the hole will contact a portion of the fixation hole. Where a fastener is inserted into the bone hole, the underside surface of the fastener head portion may engage a side portion of the fixation hole before the fastener is fully seated in the fixation hole. Where the fastener head portion engages the side portion of the fastener hole, further tightening of the fastener may cause the fastener to move longitudinally along a longitudinal axis of the plate. Further tightening of the fastener may also cause the first bone segment to move relative to the second bone segment.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • [0033]
    Preferred features of the present invention are disclosed in the accompanying drawings, wherein similar reference characters denote similar elements throughout the several views, and wherein:
  • [0034]
    FIG. 1 is a perspective view of the double barrel drill guide assembly, the plate holder, and the bone plate;
  • [0035]
    FIG. 2 is a top view of the bone plate of FIG. 1;
  • [0036]
    FIG. 3 is a side view of the bone plate of FIG. 1;
  • [0037]
    FIG. 4 is a cross-sectional view of the bone plate of FIG. 1 taken along line IV-IV in FIG. 2 with bone screws;
  • [0038]
    FIG. 5 is a side view of an alternative embodiment of the bone plate;
  • [0039]
    FIG. 6 is a cross-sectional view of the alternative embodiment of the bone plate of FIG. 5 taken along line VI-VI in FIG. 5 with bone screws;
  • [0040]
    FIG. 7 is a perspective view of a bone screw to be used with the bone plates of FIGS. 2 through 6;
  • [0041]
    FIG. 8 is a perspective exploded view of the double barrel drill guide assembly of FIG. 1;
  • [0042]
    FIG. 8 a is a detail of the underside of the handle member of the double barrel drill guide assembly shown in FIG. 8;
  • [0043]
    FIG. 8 b is a detail side view of the guide barrel assembly of the drill guide of FIG. 8;
  • [0044]
    FIG. 9 is a perspective exploded view of the single barrel drill guide assembly;
  • [0045]
    FIG. 9 a is a detail of the underside of the handle member of the single barrel drill guide assembly shown in FIG. 9;
  • [0046]
    FIG. 9 b is a detail of the flex shaft receiving groove of the single barrel drill guide assembly shown in FIG. 9;
  • [0047]
    FIG. 10 is a perspective view of the single barrel drill guide assembly;
  • [0048]
    FIG. 11 is a perspective view of an alternative embodiment of the single barrel drill guide assembly;
  • [0049]
    FIG. 12 is a detail of the hinge connection between the drill guiding barrel and the outer stem of the alternative embodiment of the single barrel drill guide assembly shown in FIG. 11;
  • [0050]
    FIG. 13 is a side view of an offset guide barrel assembly for use with the drill guide of FIG. 1;
  • [0051]
    FIG. 14 is a top view of a bone plate for use with the drill guide of FIG. 1 incorporating the offset barrel of FIG. 13;
  • [0052]
    FIG. 15 is a side view of an exemplary bone screw for use with the drill guide of FIG. 1;
  • [0053]
    FIG. 16 is a side view of the bone plate of FIG. 14 installed across a pair of vertebra with a bone screw of FIG. 15.
  • DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
  • [0054]
    Referring to FIG. 1, there is shown an exemplary double barrel drill guide assembly 100 and plate holder 140, which are adapted for use with a slotted cervical spine locking bone plate 160. While the bone plate, and plate holder and drill guide assembly are shown and described as a cervical plate for use in the cervical region of the spine, it will be appreciated that the bone plate features are applicable to other bone plates and that the drill guide assembly and plate holder are also usable with other bone plates. Assembly 100 includes a handle member 106, an offset handle stem 110, release sleeve 120, outer stem 126, and drill guiding barrels 130 a and 130 b. Handle member 106 of drill guide assembly 100 can be incrementally swiveled by pressing and holding button cam 108. Releasing the button cam 108 locks handle 106 in place with relation to offset handle stem 110.
  • [0055]
    With reference to FIG. 2, cervical spine locking bone plate 160 is roughly dog-bone shaped with two pairs of fixation holes, upper fixation holes 170 a, and lower fixation holes 170 b; and a slot 180 along the longitudinal axis 181 of bone plate 160. Exemplary thicknesses of bone plate 160 range from approximately 1.5 mm to approximately 4 mm, although other thicknesses are possible and bone plate 160 can be fabricated from titanium, alloys of titanium, stainless steel, or other biocompatible materials. Each end of slot 180 preferably is threaded, countersunk, or both to allow plate holder 140 to be coupled to bone plate 160. As shown in FIGS. 3 and 4, underside 184 of bone plate 160 preferably is contoured along its longitudinal axis 181 and its transverse axis 184 to match the outer surface of the vertebrae to which it will be attached. Angles of fixation holes are determined in relation to axes 171, 173 perpendicular to a plane formed by points 174 a-d (shown in FIGS. 2 and 3) centered over fixation holes 170 a, 170 b on the extended top surface of bone plate 160. In bone plates with more than two pairs of fixation holes, the end pairs of fixation holes are used to form the reference plane. The conical inner surfaces 172 of the fixation holes 170 a, 170 b are oriented so that the tips of bone fasteners bone screws 190 are locked at an inward angle γ of about 1° to about 10°, preferably about 4.3°, with respect to axes 171, 173. FIG. 3 shows the upper pair of fixation holes 170 a oriented so that the tips of bone fasteners 190 extend in an upward direction with respect to the spine at an angle α with respect to the axis 171. The lower pair of fixation holes 170 b is oriented downward with respect to the spine at an angle β with respect to axis 173. The upward angle α of the upper pair of fixation holes 170 a can vary from 0 to 15°, and is preferably about 12°, while the downward angle β of the lower fixation holes 170 b can vary from 0 to 10°, and preferably is about 6°.
  • [0056]
    While the bone plate 160 has been shown as having two pairs of fixation holes 170 a and 170 b, the bone plate may have additional pairs of fixation holes 170 c, 170 d, etc., in order to bridge additional vertebrae. The fixation holes located between the fixation holes 170 a, 170 b located at the ends of the bone plate are preferably oriented perpendicular to the plane formed by the holes 170 a, 170 b, but may vary approximately 50 upward or downward with respect to the spine, and may angle toward the central longitudinal axis 181 as viewed from either end of bone plate 160 with an angle y that matches that of holes 170 a, 170 b. Additionally, while bone plate 160 has been illustrated and described with pairs of fixation holes, it may also be provided with a single fixation hole for each vertebra or combinations thereof.
  • [0057]
    Fixation holes 170 a, 170 b may be threaded, with conical bone screw head 194 threaded to match, as shown in FIG. 7. Conical threads 195 of bone screw head 194 may have a higher pitch than the bone engaging lower threads 192. This difference in thread pitch between the conical threads 195 and the lower thread 192 results in compression between the plate and vertebra as the bone screw 190 is inserted.
  • [0058]
    FIG. 5 shows a side view of an alternative embodiment of the cervical spine locking bone plate. Bone plate 260 has three pairs of fixation holes 270 a, 270 b, 270 c, although more than three pairs of fixation holes are possible. FIG. 6 is a cross sectional view of bone plate 260 with bone screws 190. As shown in FIGS. 5 and 6, underside 284 of bone plate 260 is contoured to match the outer surface of the vertebrae to which it will be attached. Angles α, β, and γ of holes 270 a, 270 b may take the same values as angles α, β, and γ of holes 170 a, 170 b of bone plate 160. Axes 275 of the additional pair of holes 270 c are preferably perpendicular to the plane formed by the holes 270 a, 270 b, as viewed from the side of bone plate 260. As viewed from either end of bone plate 260, central axes 275 may have an orientation within the same range as angle γ of axes 171, 173 of bone plate 160.
  • [0059]
    FIGS. 5 and 6 also show an optional step feature 262, which preferably forms a shoulder or flange to accommodate the shape of the sacral promontory to facilitate placing bone plate 260 on the sacral plate. The step feature is also an optional feature of bone plate 160.
  • [0060]
    Referring to FIG. 8, plate holder 140 includes rod 141 that preferably is cylindrical for most of its length (preferably approximately 200 mm long), preferably with threads 143 at distal end 142 of rod 141. Rod 141 couples to bone plate 160. Bone plate 160 preferably has threads 183 at end 182 of slot 180 to mate with threads 143 at distal end 142 of rod 141. Alternatively, distal end 142 of plate holder 140 may have expandable bushings that mate with a counter-bored end 182 of slot 180 of bone plate 160. Proximal end 144 of plate holder 140 may have a non-circular cross-section, such as a hexagonal shape. Non-circular shapes other than hexagonal may also be used. Below proximal end 144 of plate holder 140 is a radial groove 146. Plate holder 140 allows a user to manipulate bone plate 160, 260 from a remote position without touching the plate.
  • [0061]
    As shown in FIG. 8, drill guide assembly 100 is coupled to plate holder 140 by sliding distal end 127 of outer stem 126 of drill guide assembly 100 over proximal end 144 of rod 141. Release sleeve 120 is connected to proximal end 129 of outer stem 126 in a captive non-releasable manner, such as for example, by swaging. Release sleeve 120 can be moved axially within a limited range and can be rotated with respect to outer stem 126.
  • [0062]
    Spring 122 is held captive inside release sleeve 120 above proximal end 129 of outer stem 126, biasing release sleeve 120 away from proximal end 129 of outer stem 126. Ball detents 124 normally protrude into the bore of outer stem 126, preventing sliding outer stem 126 over plate holder 140. Release sleeve 120 is pressed axially toward distal end 127 of outer stem 126 against the bias of release spring sleeve 122 to permit ball detents 124 to move outward into an area of greater inside diameter (not shown) of the release sleeve 120, allowing drill guide assembly 100 to be pushed farther onto plate holder 140. Removing pressure from release sleeve 120 results in the bias of release sleeve spring 122 returning release sleeve 120 to its axial position farthest from bone plate 160, forcing ball detents 124 inward to engage radial groove 146 in plate holder 140, locking drill guide assembly 100 to plate holder 140.
  • [0063]
    Release sleeve 120 has a non-circular, preferably hexagonal, hole 128 at its upper end, the perimeter of which hole 128 engages non-circular proximal end 144 of plate holder 140. Although hole 128 and proximal end 144 are shown as hexagonal, it will be appreciated that other mating shapes are possible. Release sleeve 120 can be rotated in relation to outer stem 126 to screw and unscrew plate holder 140 to allow engagement of plate holder 140 with, and disengagement of plate holder 140 from, bone plate 160. Although the connection between the drill guide assembly and the plate holder has been described as a stem coaxial with and sliding over a rod, other embodiments are possible including, for example, a drill guide assembly with a stem attaching to the side of a plate holder.
  • [0064]
    Handle member 106 is offset from outer stem 126 by offset handle stem 110, allowing greater visibility and access to bone plate 160 and vertebrae. Handle stem 110 is mechanically attached to outer stem 126, for example by welding, brazing, or friction fit. Handle member 106 can be pivoted about offset handle stem 110 by pressing button cam 108 and rotating handle member 106, providing still greater visibility and access as the surgeon alternates sides of plate 160 and vertebrae on which he is working. Handle member 106 is retained on handle stem 110 by means of a set screw 112 loosely engaging a handle stem radial groove 113. Pressing button cam 108 against the bias of cam spring 116 moves the detents 109 of the button cam 108 out of engagement with detent grooves 115 (shown in FIG. 8 a) in handle member 106 while the detents 109 remain engaged with detent grooves 111 of handle stem 110, allowing handle member 106 to be rotated with respect to offset handle stem 110, with optional ball bearings 114 facilitating rotation. Releasing pressure on button cam 108 allows cam spring 116 to return detents 109 of button cam 108 to engagement with detent grooves 115 of handle member 106, while maintaining engagement between detents 109 of button cam 108 and detent grooves 111 of handle stem 110, preventing rotation of handle member 106 in relation to handle stem 110.
  • [0065]
    Drill guiding barrels 130 a, 130 b are mechanically attached to outer stem 126, for example by brazing, welding, or friction fit. Drill guiding barrels 130 a, 130 b may have multiple insertion locations 133 with predetermined trajectories forming passageways that are aligned through a single exit location 135. For example, FIG. 8 b shows drill guiding barrel 130 a with two insertion locations 133 forming passageways along axes 134 a, 134 b. One trajectory may be substantially perpendicular to the bone plate while other trajectories may be offset and/or inclined with respect to the perpendicular trajectory. The predetermined trajectories preferably match the various trajectories of fixation holes 170 of bone plate 160 and allow greater precision than is possible with adjustable trajectory drill guides. The drill guiding barrels are shown with two insertion locations 133 and two predetermined trajectories. However, there may be additional insertion locations 133 with other predetermined trajectories to allow the drill guide to be used with a variety of bone plates. Optionally, drill guiding barrels 130 a, 130 b may have a single insert location 133 and a single exit location 135. Finally, drill guiding barrels 130 a, 130 b may have a single insertion location 133 and more than one exit location 135, or multiple insertion locations 133 and multiple exit locations 135. Guiding barrels 130 a, 130 b are preferably sized to allow passage of fixation pins or bone screws, drills, taps, and awls. Slotted holes 137 in guiding barrels 130 a, 130 b allow a surgeon to see the fixation components and tools as they are inserted into the guiding barrels 130 a, 130 b. Drill guiding barrels 130 a and 130 b have a tab 132 that engages slot 180 of bone plate 160 to prevent rotation of drill guide assembly 100 in relation to bone plate 160.
  • [0066]
    FIG. 9 shows an exploded view of an exemplary single barrel drill guide assembly 200 and plate holder 140, which are adapted for use with slotted cervical spine locking bone plate 160. While the bone plate, and plate holder and drill guide assembly are shown and described as a cervical plate for use in the cervical region of the spine, it will be appreciated that the drill guide assembly and plate holder are also usable with other bone plates. Assembly 200 includes a handle member 206, an offset handle stem 210, release sleeve 220, outer stem 226, and drill guiding barrel 230. Handle member 206 of drill guide assembly 200 can be incrementally swiveled by pressing and holding button cam 208. Releasing button cam 208 locks the handle in place with relation to the handle stem 210.
  • [0067]
    As shown in FIGS. 9 and 10, drill guide assembly 200 is coupled to plate holder 140 by sliding distal end 227 of outer stem 226 of the drill guide assembly 200 over proximal end 144 of plate holder 140. Ball detents 224 normally protrude into the bore of outer stem 226, preventing sliding outer stem 226 over plate holder 140. Release sleeve 220 is pressed axially toward distal end 227 of outer stem 226 against the bias of release spring sleeve 222 to permit ball detents 224 to move outward into an area of greater inside diameter (not shown) of the release sleeve 220, allowing drill guide assembly 200 to be pushed farther onto plate holder 140. Removing pressure from release sleeve 220 results in the bias of release sleeve spring 222 returning release sleeve 220 to its axial position farthest from bone plate 160, forcing ball detents 224 inward to engage plate holder radial groove 146, locking drill guide assembly 200 to plate holder 140. Outer stem 226 has a locking tab 232 at its distal end that is inserted into slot 180 of locking plate 160 to prevent rotation of, and provide alignment of, the drill guide assembly 200 in relation to the bone plate 160.
  • [0068]
    Release sleeve 220 has a hexagonal hole 228 at its upper end, the perimeter of which hole 228 engages hexagonal proximal end 244 of plate holder 240. Although hole 228 and proximal end 144 are shown as hexagonal, it will be appreciated that other mating shapes are possible. Release sleeve 220 can be rotated with respect to outer stem 226 to screw plate holder 140 into, and unscrew plate holder 140 from, the bone plate 160.
  • [0069]
    Handle member 206 is offset from outer stem 226 by offset handle stem 210, allowing greater visibility and access to the bone plate and vertebrae. Handle member 206 can be pivoted about handle stem 210 by pressing button cam 208 and rotating handle member 206, providing still greater visibility and access as the surgeon alternates sides of the bone plate 160 and vertebrae on which he is working. Handle member 206 is retained on handle stem 210 by means of a set screw 212 loosely engaging handle stem radial groove 213. Pressing button cam 208 against the bias of cam spring 216 moves detents 209 of button cam 208 out of engagement with detent grooves 215 (shown in FIG. 9 a) in handle member 206 while detents 209 remain engaged with detent grooves 211 of handle stem 210, allowing handle member 206 to be rotated in relation to handle stem 210. Releasing pressure on button cam 208 allows cam spring 216 to return detents 209 of button cam 208 to engagement with detent grooves 215 of handle member 206, while maintaining engagement between detents 209 of button cam 208 and detent grooves 211 of handle stem 210, preventing rotation of handle member 206 in relation to handle stem 210.
  • [0070]
    Single barrel drill guide assembly 200 offers the advantage of greater visibility for the surgeon because only one side of the plate is obscured by drill guiding barrel 230 at a time. Drill guiding barrel 230 is attached to outer stem 226 by flex shaft 250 (approximately 90 mm long in its major dimension and approximately 2 mm in diameter) made of stainless steel or other flexible biocompatible material, which passes through stem hinge projections 252 a-d on outer stem 226 and drill guiding barrel hinge projections 234 on drill guiding barrel 230. Flex shaft 250 is bent to provide a finger lever 258 for manipulating the drill guiding barrel 230. Dowel pin 236 is inserted through drill guiding barrel dowel pin hole 238 in drill guiding barrel hinge projection 234 and flex shaft dowel pin hole 254 in flex shaft 250 to lock the drill guiding barrel 230 to flex shaft 250 so that the drill guiding barrel 230 and flex shaft 250 rotate together within stem hinge projections 252 a-d. Flex shaft 250 has a reduced diameter section 251, for example approximately 1 mm for a length of 9 mm. Lower stem hinge projections 252 c, 252 d are offset from upper stem hinge projections 252 a, 252 b, causing flex shaft 250 to be slightly bowed at reduced diameter section 251, creating a spring force biasing flex shaft finger lever 258 in the direction of . Upper stem hinge projection 252 a has flex shaft receiving grooves 256 a, 256 b that receive the inner radius 253 at the location where flex shaft 250 bends to form flex shaft finger lever 258, locking drill guiding barrel 230 on either left or right side, respectively, of drill guide assembly 200. Drill guiding barrel 230 is moved from left to right side by pulling flex shaft 250 upward until the flex shaft finger lever 258 is clear of flex shaft receiving groove 256 a and rotating combined locking drill guide barrel 230 and flex shaft 250 until flex shaft finger lever 258 is positioned above flex shaft receiving groove 256 b. Releasing flex shaft 250 allows flex shaft finger lever 258 to seat in flex shaft receiving groove 256 b due to the spring force of bowed flex shaft lower end 259, the spring force resulting from the bow in reduced diameter section 251 of flex shaft 250.
  • [0071]
    Preferably, drill guiding barrel 230 has multiple insertion locations 233 with predetermined trajectories preferably inclined or offset from a single exit location 235, although a drill guiding barrel 230 with a single insertion location 233 and a single exit location 235 is possible. In addition, a drill guiding barrel 230 with a single insertion location 233 and more than one exit location 235 is possible. Multiple insertion locations 233 provide proper trajectories when drill guiding barrel 230 is moved to alternate sides of the plate and also provide for the various trajectories needed for the upper and lower fixation holes 170 a, 170 b of bone plate 160. The predetermined trajectories allow greater precision than possible with adjustable trajectory drill guides. Guiding barrel 230 allows passage of fixation pins or bone screws, drills, taps, and awls. Slotted holes 237 in guiding barrel 230 allow a surgeon to see the fixation components and tools as they are inserted into the guiding barrel 230.
  • [0072]
    FIG. 11 shows an alternate embodiment of a single barrel drill guide. Drill guide assembly 300 has a relatively long (representative length: approximately 80 mm) drill guiding barrel 330 with a depth stop (a shoulder, not shown) inside the drill guiding barrel 330 (representative outside diameter: approximately 10-12 mm) that stops the drill bit at a pre-determined depth. Handle member 306, button cam 308, offset handle stem 310, outer stem 326, and release sleeve 320 correspond to handle stem 106, button cam 108, offset handle stem 110, outer stem 126, and release sleeve 120 of drill guide assembly 100. Tab 335 is attached to outer stem 326, preferably by welding or brazing, and has a horizontal section 335 a and vertical section 335 b. Pin 350 is attached to tab horizontal section 335 a, preferably by welding, brazing, or mechanical connection; and is parallel to outer stem 326. Pin 350 has a slot 337 beginning at its upper end and extending through a portion of the length of pin 350. Slot 337 separates hemispherical retainers 355 a, 355 b, which have a greater diameter than the section of pin 350 below the retainers 355 a, 355 b. Retainers 355 a, 355 b secure drill guiding barrel hinge 334 on pin 350. To switch drill guiding barrel 330 to the opposite side of bone plate 160, the surgeon pulls drill guiding barrel 330 towards himself so that drill guiding barrel hinge 334 clears tab vertical section 335 b, allowing the surgeon to pivot the drill guiding barrel 330 to the opposite side. The surgeon's pulling of drill guiding barrel 330 toward himself forces the retainers 355 a, 355 b closer together as upper surface 339 of drill guiding barrel hinge 334 contacts retainers 355 a, 355 b, creating a spring force biasing drill guide barrel hinge 334 away from the surgeon. The drill guiding barrel 330 is then released and returned to its lower position by the spring force of the compressed retainers 355 a, 355 b against upper surface 339 of drill guide barrel hinge 334 such that drill guiding barrel hinge 334 is held in angular position by tab 335.
  • [0073]
    FIG. 13 illustrates an alternative embodiment of a guide barrel for use with the inventive drill guide which may allow the surgeon to compress the intervertebral space (i.e. the disc space) between adjacent vertebrae when the fasteners are tightened in their respective plate holes. Using the disclosed barrel arrangement, compression of the intervertebral disc space may be achieved simply by tightening the bone screws in the plate and without the need for additional tools.
  • [0074]
    Compression of the disc space may be important for a number of reasons. Specifically, where an intervertebral fusion spacer has been installed between the vertebra, compression along the spine axis may serve to provide proper initial seating and loading of the spacer between the end plates. This may eliminate any spaces or gaps between the end plates and the spacer. Also, compression may promote fusion by stressing both the end plates and the spacer. Compression may also be used to return the disc space to its normal height.
  • [0075]
    Thus, the guiding barrels 1130 a, b of the drill guide of this embodiment may be arranged so that at least one bone hole formed in at least one vertebra is slightly longitudinally offset from the center of the respective plate hole 170 a at one end of the bone plate 160. In general, the drill guide of this embodiment will be used with a plate 160 having at least two plate holes 170 a, 170 b (see FIG. 14) that overly at least a pair of adjacent vertebra (see FIG. 16). The plate may be fixed to a first of the pair of vertebrae using a bone screw 1190 inserted through at least one of the plate holes 170 b. The drill guide with offset guiding barrels 1130 a, b, may then be engaged with the plate 160 and used to form at least one offset bone hole 1200 in the second of the pair of vertebrae through plate hole 170 a. Thereafter, when bone screws 1190 are inserted in the offset bone holes 1200 in the second vertebra, the heads 1192 of the screws 1190 may overhang the far side of plate holes 170 a since they are non-concentric with the plate holes 170 a. As such, when the bone screws 1190 are driven into the offset bone holes 1200, the under-surface 1195 of the screw head 1194 will contact the far side of conical inner surface 172 of the plate holes 170 a. As the bone screw 1190 is driven farther into the bone, the interaction between the under-surface 1195 of the screw head 1194 and the conical inner surface 172 of the plate holes 170 a causes the screw 1190 (and the underlying second vertebra) to move longitudinally with respect to the plate 160 until the screw is centered within the plate hole 170 a, thus reducing the distance between the vertebrae. In this manner, the pair of vertebrae may be moved together by an amount equal to the distance by which the offset bone holes 1200 are offset from the plate holes 170 a.
  • [0076]
    It is noted that various tools may be placed through the guide barrels of the disclosed drill guide to form holes in the underlying bone. For example, an awl or probe may be used to break the cortical shell of the bone. A probe may also be used to dislodge and/or remove cancellous bone underlying the cortical bone to make way for a bone screw. A drill may be used to form the bone hole, and a tap may be used to form threads in the bone hole. Where self-tapping screws are used, the tap may not be required, and where self-drilling screws are used, the drill and tap may not be required.
  • [0077]
    Furthermore, while this procedure is described in relation to a bone plate having only two pairs of plate holes 170 a, b, it will be appreciated by one of skill in the art that this offset guide barrel feature may be used with plates having three or more pairs of plate holes (i.e. those that span multiple disc spaces or “levels”). In such cases, compression of multiple “levels” may be achieved by fixing the plate to at least one vertebra, and then creating offset bone holes in at least one vertebra. For example, where a two-level plate is used (i.e. the plate has three pairs of bone screw holes 270 a, 270 b, 270 c (see FIG. 5)) , at least one pair of plate holes may be fixed to an associated vertebra, while offset holes may then be formed in the vertebrae adjacent this “fixed” vertebra using a drill guide having offset guide barrels 1130 a, b as previously described. By driving bone screws into these offset bone holes, these adjacent vertebrae may be moved in the direction of the “fixed” vertebrae, thus compressing the associated disc space.
  • [0078]
    As shown in FIG. 14, an exemplary offset bone hole 1200 is indicated as “X,” while the center point of the bone screw hole 170 a is indicated as “Y.” The longitudinal distance from the bone plate slot end-hole 182 to the center of the bone screw hole 170 a is designated “L1,” while the longitudinal distance from the bone plate slot end-hole 182 to the center “X” of the offset bone hole 1200 is designated “L2.” An axis “D-D” formed by points “X” and “Y” may be oriented substantially parallel to the longitudinal axis “A-A” of the bone plate 160. A bone screw 1190 (FIG. 15) inserted into a hole formed at point “X” will, when tightened into the vertebra, move toward point “Y” due to the previously described interaction of the bone screw head 1194 with the side of the conical inner surface 172 of the fastener hole 170 a. This movement of the bone screw 1190 along axis “D-D” will also move the attached vertebra 2000 along axis “D-D” toward the adjacent vertebra 2002 to which plate 160 has already been firmly affixed. Thus, the two vertebra are drawn closer together along axis “D-D.”
  • [0079]
    In the embodiment illustrated in FIG. 16, the bone plate may be attached to adjacent vertebra 2000, 2002 of the spine such that the plate axis “A-A” may be substantially aligned with the longitudinal axis of the spine. One of a pair of bone screws 1190 is shown engaged with the leftmost plate hole 170 b and vertebra 2002. One of a second pair of bone screws 1190 is shown partially installed in one of a pair of rightmost plate holes 170 a, under which a pair of offset holes 1200 have been formed in vertebra 2000. A portion of the underside 1195 of the screw head 1194 can be seen overlying one side of the conical inner surface 172 of the plate hole 170 a. Compression of the disc space 2004 between the vertebrae 2000, 2002, may thereafter be achieved substantially along the axis of the spine by fully tightening the second pair of bone screws 1190 in vertebra 2000.
  • [0080]
    To form bone holes having the desired offset, guiding barrels 130 a, b, outer stem 126, and plate holder 140 may be configured and arranged so that the center of the guiding barrels 130 a, b and the center of the outer stem and plate holder 126, 140 are separated by a distance equal to length “L2” so that when the plate holder 140 is engaged with slot end hole 182 and the outer stem 126 is engaged with the plate holder 140, the guiding barrels 130 a, b will be aligned with offset bone hole insertion point “X.”
  • [0081]
    In one embodiment, the distance “L1” from the center of the slot end hole 182 to the center of each plate hole 170 a, when measured along axis “D-D” (FIG. 14) is about 5.5 mm, and the distance “BL” (FIG. 13) between the center of the plate holder 126 and the center of each guide barrel 1130 a, b is about 6.0 mm. Thus, when the drill guide is fit to the plate and holes drilled through guide barrels 1130 a, b, the resulting bone holes will be offset from the center of each plate hole 170 a by about 0.5 mm, which will result in a corresponding compression of the associated intervertebral disc space of about 0.5 mm when the screws 1190 are fully seated in the vertebrae.
  • [0082]
    The plate guiding barrels 1130 a, b, may be configured so that the distance between points “X” and “Y” along axis “D-D” is in the range of from about 0.0 mm to about 0.8 mm, thus providing longitudinal compression of the vertebral bodies of from about 0.0 mm to about 0.8 mm when the associated “offset” bone screws 190 are fully tightened in their plate holes 170 a. In a preferred embodiment, the guiding barrels, outer stem and plate holder are configured so that the distance between points “X” and “Y” may be about 0.5 mm, thus allowing longitudinal compression of bone segments of from about 0.5 mm when the fasteners are tightened within the appropriate bone screw holes. It should be noted that larger offset dimensions may be provided, as will be apparent to one of ordinary skill in the art.
  • [0083]
    It will also be appreciated that the offset guide barrel feature described herein may be implemented with any of the single barrel or double barrel drill guides disclosed herein. Moreover, while the bone plate, drill bit, and drill guide assembly are shown and described for use in fixing adjacent vertebra of the spine, it will be appreciated that the drill guide assembly may be utilized with any suitable bone plate or other structure that may be secured to bone using bone fasteners. Alternatively, the drill guide may be used without a bone plate to guide the drilling of fastener holes in bone at any appropriate location in the body.
  • [0084]
    The method of drilling holes in vertebrae with the system disclosed above will now be described. A surgeon may inserts a plate holder into a slotted hole in a bone plate. The surgeon then releasably locks a drill guide assembly onto the plate holder. The bone plate is applied to the appropriate vertebrae by a surgeon holding a handle of the drill guide assembly. The surgeon then aligns a drill bit with the appropriate insertion location in the appropriate drill guiding barrel of the drill guide assembly and inserts the drill bit into the drill guiding barrel. The surgeon then drills a first hole coaxial with the central axis of a first fastener hole in the plate. A first bone screw is then inserted into the drill guiding barrel and threaded into the first hole. If a double barrel drill guide assembly is being used, the surgeon then aligns the drill bit with the appropriate insertion location of the adjacent drill guiding barrel. If a single barrel drill guide assembly is being used, the surgeon pivots the drill guiding barrel until it is aligned above a fastener hole adjacent to the first fastener hole in the plate and aligns the drill bit with the appropriate insertion location of the drill guiding barrel. The surgeon then drills a second hole coaxial with the central axis of a second fastener hole in the plate and installs a second bone screw. The surgeon then rotates counterclockwise a release sleeve on the drill guide assembly, which disengages the plate holder from the plate. The surgeon removes the drill guide assembly and attached plate holder from the plate and inserts the plate holder into a second hole in the bone plate by rotating the release sleeve counterclockwise, the process of drilling holes and installing bone screws in adjacent through-holes of the plate and removing the drill guide assembly and plate holder is repeated until all pairs of adjacent holes have been drilled and bone screws inserted.
  • [0085]
    When using the drill guide having an offset barrel 1130 a, b to provide a compression of adjacent vertebrae, the surgeon may first insert a pair of bone screws through a corresponding pair of plate holes 170 b overlying the first of a pair of adjacent vertebrae, thus fixing the plate 160 to the first vertebra. The surgeon may then engage a drill guide having at least one offset barrel 1130 a, b with the plate 160 as described above, and may use the barrel to form offset holes 1200 in the bone underlying plate holes 170 a which overly the second of the pair of vertebrae. These holes may be formed using an awl, followed by a drill and tap. Alternatively, when using self tapping or self drilling bone screws, the surgeon may use an awl to form the hole. A probe may also be used to remove or dislodge cancellous bone within the hole. Bone screws 1190 may then be placed in the holes and tightened until the undersides 1195 of the screw heads 1194 contact a portion of the respective plate holes 170 a. Further tightening of the screws 1190 may cause the screws and the underlying second vertebrae to move toward the first vertebra, thus reducing the distance between the two vertebrae. An intervertebral spacer placed between the vertebrae will thus be subjected to the compression force associated with the reduction in distance, and the previously discussed benefits of such compression will be provided.
  • [0086]
    While the method has been described in relation to a plate 160 having two pairs of plate holes (i.e. the plate is sized to span a single intervertebral disc space), plates configured for multiple-level fixation may also be used. Thus, FIG. 5 shows a two-level plate 260 having three pairs of plate holes 270 a, 270 b and 270 c, where each pair of holes may be associated with a separate vertebral body. With a two-level plate, either one or two levels may be compressed by fixing various combinations of hole pairs. Thus, holes 270 a may be fixed to the associated vertebra, and offset holes may be drilled through plate holes 270 b and 270 c to facilitate compression of the disc spaces between the associated vertebrae. Likewise, plate holes 270 a and 270 b may be fixed to the associated vertebrae, with offset holes drilled only through holes 270 c to compress only the disc space located between the vertebrae associated with holes 270 b and 270 c. Where multiple disc spaces will be compressed, it may be advantageous to compress them incrementally so that an even compression of the disc spaces may be provided. Thus, where holes 270 a are fixed and offset holes are drilled through plate holes 270 b and 270 c, screws should first be driven into the offset holes associated with plate holes 270 b to compress the disc space between vertebrae associated with holes 270 a and 270 b. Screws may then be driven into the offset holes associated with plate holes 270 c to subsequently compress the disc space located between vertebrae associated with holes 270 b and 270 c.
  • [0087]
    While the invention has been shown and described herein with reference to particular embodiments, it is to be understood that the various additions, substitutions, or modifications of form, structure, arrangement, proportions, materials, and components and otherwise, used in the practice and which are particularly adapted to specific environments and operative requirements, may be made to the described embodiments without departing from the spirit and scope of the present invention. For example, various means may be used to attach the plate holder to the bone plate or to the drill guide assembly. In addition, the plate may be of various thicknesses, shapes, and contours; and have various fixation hole configurations.
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Clasificaciones
Clasificación de EE.UU.606/96
Clasificación internacionalA61B17/80, A61B17/58, A61L, A61B17/17, A61F2/00
Clasificación cooperativaA61B17/1757, A61B17/8057, A61B17/1728
Clasificación europeaA61B17/80F2, A61B17/17P
Eventos legales
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12 Dic 2006ASAssignment
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