WO1996008206A1 - Osteosynthesis apparatus - Google Patents

Osteosynthesis apparatus Download PDF

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Publication number
WO1996008206A1
WO1996008206A1 PCT/US1995/011681 US9511681W WO9608206A1 WO 1996008206 A1 WO1996008206 A1 WO 1996008206A1 US 9511681 W US9511681 W US 9511681W WO 9608206 A1 WO9608206 A1 WO 9608206A1
Authority
WO
WIPO (PCT)
Prior art keywords
plate member
openings
bone screw
slot
bone
Prior art date
Application number
PCT/US1995/011681
Other languages
French (fr)
Inventor
Kevin T. Foley
Peter M. Klara
Keith Maxwell
Lance Middleton
Matthew M. Morrison
Original Assignee
Smith & Nephew Richards Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Smith & Nephew Richards Inc. filed Critical Smith & Nephew Richards Inc.
Priority to AU39861/95A priority Critical patent/AU710957B2/en
Priority to JP8510340A priority patent/JPH11504227A/en
Priority to CA002199866A priority patent/CA2199866C/en
Publication of WO1996008206A1 publication Critical patent/WO1996008206A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8033Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers
    • A61B17/8038Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers the additional component being inserted in the screw head
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7059Cortical plates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8033Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers

Definitions

  • the present invention relates to an improved bone or spinal fixation apparatus in the form of an elongated plate member and a locking bone screw.
  • the apparatus has particular utility in anterior cervical spine fixation by providing a plate that allows for angulation of the bone screws and a locking bone screw that secures the bone screws into the plate member at a selected angle corresponding to a thick region of the bone mass.
  • bone screws are employed in the fixation of the spine where the implantation of the bone screws is a surgical procedure in which one or more surgical openings are formed in adjacent portions of the spine and threaded bone screws are implanted into the surgical openings.
  • Connective structures such as rods or plates extend between the various spine members and are connected to the spine members by the implanted bone screws.
  • both a posterior and an anterior approach is used and the use of plating systems for posterior internal fixation of the spine is well known.
  • Several plating systems have also been developed for anterior internal fixation of the spine.
  • the Syracuse l-plate provides a number of differently-sized l-shaped plates which are engaged across the vertebrae.
  • a contoured anterior spinal fixation plate is known which includes a number of screw openings through the contoured plate. The number of openings simply provide different locations for engaging a bone screw to the vertebrae, and does not allow for angulation of the bone screws.
  • a further problem with the application of a spinal fixation system is the placement of such a system in the cervical region where anatomical fit and the lack of bone mass is a problem
  • a bone fixation apparatus comprises a plate member having a longitudinal axis, upper and lower surfaces, opposed longitudinal side edges, at least two pairs of circular openings and at least one elongated slot positioned along the longitudinal axis of the plate member, said openings and slot each forming a cavity extending between the upper and lower plate member surfaces wherein at least some of said cavities are narrower at the plate member upper and lower surfaces than at a plane located between said surfaces, said openings and slot being shaped to allow for transverse and longitudinal angulation of an implanted bone screw, a pluality of bone screws each having a threaded first end portion adapted for implantation into a patient's bone mass and an enlarged second end portion; and locking means associated with the second end portion of each bone screw for expanding the second end portion to grip a cavity wall of the plate member and for locking each bone screw into a selected position within at least some of the openings and/or slot of the plate member.
  • the present invention provides an apparatus that can be made small enough for anterior cervical spine applications and is preferably of a size which is suitable to be placed on adjoining vertebrae, the desired size being selected to suit the particular intended application of the apparatus.
  • the plate is preferably curved in the transverse plane.
  • the distance between the opposed longitudinal side edges is preferably less in the central region of the plate member than in the end regions of the plate so that, for example, the edges are of concave appearance.
  • the upper and/or lower surfaces edges of the openings and slot may advantageously be bevelled.
  • the bone screw has an enlarged second end which is shaped preferably to allow engagement between that end of the screw and the side walls of a cavity in a bone fixation plate member upon operation of the locking means.
  • a particularly suitable screw has an enlarged second end which is spherically shaped or part-spherical.
  • the locking means preferably is adapted to cause an interference fit between the enlarged second end of the screw and the walls of a cavity and preferably comprises a locking member which is of a size and shape to fit into a bore located in the second end of the bone screw.
  • the second end has a central bore which has threads and at least two radial slits which intersect the bore.
  • the locking means may comprise a threaded locking member which may be screwed into the central bore thereby to expand the second end portion at the radial slits.
  • a plate member which is adapted for use in a bone fixation apparatus has upper and lower surfaces, a longitudinal axis, opposed longitudinal side edges, two pairs of circular openings and at least one elongated slot positioned along the longitudinal axis of the plate member, said openings and slot each forming a cavity extending between the upper and lower plate member surfaces wherein at least some of said cavities are narrower at the plate member upper and lower surfaces than at a plate located between said surfaces, said openings and slot being shaped to allow for transverse and longitudinal angulation of an implanted bone screw.
  • a bone screw capable of being locked into a selected position in a plate member comprises a threaded first end portion, a bone screw capable of being locked into a selected position in a plate member, comprising a threaded first end portion adapted for implantation into a patient's bone mass and an enlarged second end portion; and locking means associated with the second end portion of the bone screw for expanding the second end portion to grip portions of a wall surface of an opening in a plate member and for locking the bone screw into a selected position within said opening of a plate member.
  • Figure 1 is an anterior view of the preferred embodiment of the apparatus of the present invention illustrating its placement on the anterior cervical bone tissue;
  • Figure 2 is a plan view of the preferred embodiment of the apparatus of the present invention illustrating a plate member
  • Figure 3 is a side view of the plate shown in Figure 2;
  • Figure 4 is a sectional view of a portion of the plate shown at lines 4-4 of Figure 2;
  • Figure 5 is a sectional view of a portion of the plate shown at lines 5-5 of Figure 2;
  • Figure 6 is a partial sectional view of the plate shown at lines 6-6 of Figure 2;
  • Figure 7 is a front view of the preferred embodiment of the apparatus of the present invention illustrating a locking bone screw
  • Figure 8 is a front view of the preferred embodiment of the apparatus of the present invention illustrating a locking member that connects to the bone screw of Figure 7;
  • Figure 9 is a top view of the bone screw of Figure 7 with the locking member of Figure 8 in its locked position;
  • Figure 10 is a fragmentary sectional view of the preferred embodiment of the apparatus of the present invention illustrating the bone screw of Figure 7 placed in an angled position
  • Figure 11 is a fragmentary sectional view of the preferred embodiment of the apparatus of the present invention illustrating a longitudinal range of angulation of an implanted bone screw
  • Figure 12 is a fragmentary sectional view of the preferred embodiment of the apparatus of the present invention illustrating a transverse range of angulation of an implanted bone screw.
  • FIG. 1 shows a preferred embodiment of the bone fixation apparatus of the present invention, designated generally by the numeral 10, implanted on the anterior side of cervical vertebrae V of a human patient.
  • the bone fixation apparatus 10 includes a plate member 12 and locking bone screws 14.
  • the plate 12, as shown in FIG. 2, is an elongated plate member 12 having a longitudinal axis LA and upper and lower surfaces 20, 22.
  • the plate member 12 has opposed longitudinal side edges 20-22, first and second ends 23,
  • Plate member 12 has a transverse plane TP (FIG. 2) with the plate member 12 being curved along the transverse plane TP.
  • the radius of the transverse curve cross-section is between about 7/8" to 2" and is illustrated in FIGS. 4 and 5.
  • the plate member 12 is generally flat along the longitudinal axis LA.
  • the plate member 12 includes a pair of circular openings 24 positioned at its first end 23 and a second pair of circular openings
  • At least one elongated slot 28 is positioned along the longitudinal axis LA of the plate member 12, and in a preferred embodiment three elongated slots 28 are positioned along the longitudinal axis LA of the plate member 12.
  • the circular openings 24, 26 and elongated slots 28 have a central vertical axis CA, as illustrated in FIGS. 4 and 5. In an alternative embodiment, more than two pairs of circular openings can be placed on the ends of the plate member 12.
  • the openings 24, 26 and the elongated slots 28 of the plate member 12 each form a cavity 30 with angled walls 31 extending between the upper and lower plate member surfaces 16, 18.
  • the cavities 30 are narrower at the upper and lower surfaces 16, 18 of the plate than at an intermediate location 34.
  • the diameter of the wall portions 32 are larger at the upper surface 16 than the diameter of the wall portions 32 at the lower plate surface 18, but the diameter of the wall portions 34 is always larger than that at both the upper and lower surfaces 16, 18.
  • the slightly smaller diameter of the wall portions 32 at the lower surface 18 of the plate member 12 keeps the bone screw 14 from slipping through the cavities 30 prior to insertion of the locking member 48 into the central bore 42 of the bone screw 14.
  • the angulation of the wall surfaces 31 between the upper and lower plate surfaces 16, 18 is generally about between 110° to 160°.
  • the cavities 30 of the openings 24, 26 and slots 28 are shaped to allow for a transverse angulation of generally up to about 35° in both directions from the central vertical axis CA of the openings 24, 26 and slots 28 (FIG. 12).
  • the cavities 30 of the openings 24, 26 are shaped to allow for a longitudinal angulation of generally up to about 35° in both directions from the central vertical axis of the openings 24, 26 (FIG. 12).
  • the cavities 30 of the slots 28 are shaped to allow for a longitudinal angulation of generally between 0° to 130° in both directions from the central vertical axis of the slots 28 (FIG. 11 ).
  • the openings 24, 26 and slots 28 have a bevelled surface 15 on the upper and lower plate surfaces 16, 18 as illustrated in FIGS. 4-6.
  • the geometry of the plate member 12, plus the load factors of the openings 24, 26 and slots 28, allow the plate member 12 to be somewhat bendable during implantation while still maintaining the rigidity needed for adequate fixation and immobilization of the vertebrae. Additionally, the transverse curve of the plate member
  • the bone screw 14 has an elongated shank 36, a lower tip 37, and an enlarged upper portion 40 affixed to one end of the shank 36.
  • the lower tip 37 of the bone screw 14 communicates with a helical thread 38 that begins at the lower tip 37 and terminates at the upper portion 40.
  • the enlarged upper portion 40 has a spherically-shaped outer surface 41 , a tapered central bore 42 and upper walls 43.
  • the upper walls 43 of the enlarged portion 40 have at least 2 radial slits 44 intersecting the bore 42, and in a preferred embodiment, four radial slits 44 intersecting the bore 42, as seen in FIG. 9.
  • the central bore 42 includes internal threading 46 on a portion of the frustoconical surface 45, as illustrated in FIGS. 7 and 10.
  • the spherically-shaped surface 41 of the upper portion 40 interfaces with the cavities 30 of the openings 24, 26 and elongated slots 28 (see FIG. 10) as will be described more fully hereinafter.
  • a locking member 48 as shown in FIG. 8, has lower and upper portions 50, 52 respectively and a top surface 51 , with the locking member 48 being sized and shaped to fit into the tapered central bore 42 of the bone screw 14.
  • the locking member 48 includes external threading 54 on its lower portion 50 which engages the corresponding internal threading 46 of the central bore 42.
  • a tool receptive socket such as hexagonal socket 56 (FIG. 9) is provided on the flat top surface 51 , so that the locking member 48 can be rotated using an alien wrench or other such tool or instrument.
  • the angular shape of the cavity walls 31 allows for both transverse and longitudinal angulation of an implanted bone screw 14.
  • the spherically-shaped surface 41 allows the upper portion 40 of the bone screw 14 to be freely rotatable within the plate member cavity 30 prior to insertion of the locking member 48.
  • the locking members 48 are threaded into the tapered central bore 42 of the bone screws 14.
  • the threading 54 of the locking member 48 engages the threading 46 of the central bore 42 and the radial slits 44 allow the upper wall portions 43 to expand outwardly as the locking member 48 is tightened into the central bore 42 (FIG. 9).
  • the expanding wall portions 43 grip the cavity walls 31 so as to lock each bone screw 14 into a selected position within the openings 24, 26 and slots 28 of the plate member 12 as illustrated in FIGS. 11 and 12.
  • the locking mechanism between the plate member 12 and the bone screws 14 prevents the implanted bone screws from backing out of the vertebrae.
  • This locking mechanism, plus the geometry of the plate member 12 allows the bone fixation apparatus 10 to provide a rigid construct when initially implanted. However, as the implanted bone screws loosen over time, the bone fixation apparatus 10 becomes semi-rigid and provides a construct that is somewhat flexible and compliant.
  • the configuration of the openings 24, 26 provides secure fixation at the ends of the plate member 12 while the slots 28 provide for a variation in screw placement along the longitudinal axis of the plate member 12.
  • the bone fixation apparatus 10 can be sized to be used on cervical or lumbar vertebrae in either an anterior or posterior location.
  • the bone fixation apparatus 10 can also be sized to be used on other bone surfaces in addition to vertebrae.

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Abstract

A bone fixation apparatus (10) having an elongated plate member (12) with at least two pairs of circular openings (24, 26) and at least one elongated slot (28) positioned along the longitudinal axis of the plate member (12). The plate member (12) is formed so as to include a curve in the transverse plane (TP). The openings and slot each form a cavity with walls extending between the upper and lower plate member surfaces (16, 18) with smaller diameter wall portions (32) at the plate member upper and lower surfaces and a larger diameter wall portion (34) therebetween. The openings (24, 26) and slot (28) are shaped to allow for angulation of an implanted bone screw (14). A plurality of bone screws (14) have a threaded first end portion (36) adapted for implantation into a patient's bone mass and a spherically shaped enlarged second end portion (40). A locking member (48) connects to the second end portion (40) to grip the cavity wall of the plate member (12) so as to lock each bone screw (14) into a selected position within the openings (24, 26) and slot (28) of the plate member (12).

Description

OSTEOSYNTHESIS APPARATUS
The present invention relates to an improved bone or spinal fixation apparatus in the form of an elongated plate member and a locking bone screw. The apparatus has particular utility in anterior cervical spine fixation by providing a plate that allows for angulation of the bone screws and a locking bone screw that secures the bone screws into the plate member at a selected angle corresponding to a thick region of the bone mass.
There are a number of surgical procedures which require fixation of portions of the spine with respect to one another. Typically, bone screws are employed in the fixation of the spine where the implantation of the bone screws is a surgical procedure in which one or more surgical openings are formed in adjacent portions of the spine and threaded bone screws are implanted into the surgical openings. Connective structures such as rods or plates extend between the various spine members and are connected to the spine members by the implanted bone screws.
In the treatment of spinal disorders and spinal fractures, both a posterior and an anterior approach is used and the use of plating systems for posterior internal fixation of the spine is well known. Several plating systems have also been developed for anterior internal fixation of the spine. For example, the Syracuse l-plate provides a number of differently-sized l-shaped plates which are engaged across the vertebrae. A contoured anterior spinal fixation plate is known which includes a number of screw openings through the contoured plate. The number of openings simply provide different locations for engaging a bone screw to the vertebrae, and does not allow for angulation of the bone screws. A further problem with the application of a spinal fixation system is the placement of such a system in the cervical region where anatomical fit and the lack of bone mass is a problem
Even with these known posterior and anterior plate fixation systems, there remains a need for a plate and screw system that allows for variation in screw placement along the longitudinal axis of the plate as well as providing for angulation in both the medial- lateral and the cephalad-caudal plane There is also a need for a fixation system that provides a locking bone screw mechanism for securely fastening the bone screw in the angled position within the plate There is further a need for a fixation plate that is curved to fit the contours of the vertebrae and is also somewhat bendable during implantation but rigid enough to allow fusion to take place after implantation
It is thus an object of the present invention to provide a bone fixation system that offers a strong and stable construct for maximum fusion augmentation of any bone structure and yet is versatile enough for any patient and is easy to use
According to the present invention a bone fixation apparatus comprises a plate member having a longitudinal axis, upper and lower surfaces, opposed longitudinal side edges, at least two pairs of circular openings and at least one elongated slot positioned along the longitudinal axis of the plate member, said openings and slot each forming a cavity extending between the upper and lower plate member surfaces wherein at least some of said cavities are narrower at the plate member upper and lower surfaces than at a plane located between said surfaces, said openings and slot being shaped to allow for transverse and longitudinal angulation of an implanted bone screw, a pluality of bone screws each having a threaded first end portion adapted for implantation into a patient's bone mass and an enlarged second end portion; and locking means associated with the second end portion of each bone screw for expanding the second end portion to grip a cavity wall of the plate member and for locking each bone screw into a selected position within at least some of the openings and/or slot of the plate member.
The present invention provides an apparatus that can be made small enough for anterior cervical spine applications and is preferably of a size which is suitable to be placed on adjoining vertebrae, the desired size being selected to suit the particular intended application of the apparatus. The plate is preferably curved in the transverse plane.
The distance between the opposed longitudinal side edges is preferably less in the central region of the plate member than in the end regions of the plate so that, for example, the edges are of concave appearance. The upper and/or lower surfaces edges of the openings and slot may advantageously be bevelled.
The bone screw has an enlarged second end which is shaped preferably to allow engagement between that end of the screw and the side walls of a cavity in a bone fixation plate member upon operation of the locking means. A particularly suitable screw has an enlarged second end which is spherically shaped or part-spherical. The locking means preferably is adapted to cause an interference fit between the enlarged second end of the screw and the walls of a cavity and preferably comprises a locking member which is of a size and shape to fit into a bore located in the second end of the bone screw. In a preferred embodiment the second end has a central bore which has threads and at least two radial slits which intersect the bore. In this form the locking means may comprise a threaded locking member which may be screwed into the central bore thereby to expand the second end portion at the radial slits.
According to the invention a plate member which is adapted for use in a bone fixation apparatus has upper and lower surfaces, a longitudinal axis, opposed longitudinal side edges, two pairs of circular openings and at least one elongated slot positioned along the longitudinal axis of the plate member, said openings and slot each forming a cavity extending between the upper and lower plate member surfaces wherein at least some of said cavities are narrower at the plate member upper and lower surfaces than at a plate located between said surfaces, said openings and slot being shaped to allow for transverse and longitudinal angulation of an implanted bone screw.
According to the invention, a bone screw capable of being locked into a selected position in a plate member comprises a threaded first end portion, a bone screw capable of being locked into a selected position in a plate member, comprising a threaded first end portion adapted for implantation into a patient's bone mass and an enlarged second end portion; and locking means associated with the second end portion of the bone screw for expanding the second end portion to grip portions of a wall surface of an opening in a plate member and for locking the bone screw into a selected position within said opening of a plate member.
For a further understanding of the nature and objects of the present invention, reference should be made to the following detailed description, which is given only as an example of the invention, taken in conjunction with the accompanying drawings, in which like parts are given like reference numbers, wherein: Figure 1 is an anterior view of the preferred embodiment of the apparatus of the present invention illustrating its placement on the anterior cervical bone tissue;
Figure 2 is a plan view of the preferred embodiment of the apparatus of the present invention illustrating a plate member;
Figure 3 is a side view of the plate shown in Figure 2;
Figure 4 is a sectional view of a portion of the plate shown at lines 4-4 of Figure 2;
Figure 5 is a sectional view of a portion of the plate shown at lines 5-5 of Figure 2;
Figure 6 is a partial sectional view of the plate shown at lines 6-6 of Figure 2;
Figure 7 is a front view of the preferred embodiment of the apparatus of the present invention illustrating a locking bone screw;
Figure 8 is a front view of the preferred embodiment of the apparatus of the present invention illustrating a locking member that connects to the bone screw of Figure 7;
Figure 9 is a top view of the bone screw of Figure 7 with the locking member of Figure 8 in its locked position;
Figure 10 is a fragmentary sectional view of the preferred embodiment of the apparatus of the present invention illustrating the bone screw of Figure 7 placed in an angled position; Figure 11 is a fragmentary sectional view of the preferred embodiment of the apparatus of the present invention illustrating a longitudinal range of angulation of an implanted bone screw;
Figure 12 is a fragmentary sectional view of the preferred embodiment of the apparatus of the present invention illustrating a transverse range of angulation of an implanted bone screw.
FIG. 1 shows a preferred embodiment of the bone fixation apparatus of the present invention, designated generally by the numeral 10, implanted on the anterior side of cervical vertebrae V of a human patient. The bone fixation apparatus 10 includes a plate member 12 and locking bone screws 14. The plate 12, as shown in FIG. 2, is an elongated plate member 12 having a longitudinal axis LA and upper and lower surfaces 20, 22. The plate member 12 has opposed longitudinal side edges 20-22, first and second ends 23,
25 and a center portion 21. The center portion 21 preferably has a generally smaller width in relation to a larger width at the first and second ends 23, 25. Plate member 12 has a transverse plane TP (FIG. 2) with the plate member 12 being curved along the transverse plane TP. The radius of the transverse curve cross-section is between about 7/8" to 2" and is illustrated in FIGS. 4 and 5. As shown in FIG. 3, the plate member 12 is generally flat along the longitudinal axis LA.
The plate member 12 includes a pair of circular openings 24 positioned at its first end 23 and a second pair of circular openings
26 positioned at its second end 25. At least one elongated slot 28 is positioned along the longitudinal axis LA of the plate member 12, and in a preferred embodiment three elongated slots 28 are positioned along the longitudinal axis LA of the plate member 12. The circular openings 24, 26 and elongated slots 28 have a central vertical axis CA, as illustrated in FIGS. 4 and 5. In an alternative embodiment, more than two pairs of circular openings can be placed on the ends of the plate member 12.
The openings 24, 26 and the elongated slots 28 of the plate member 12 each form a cavity 30 with angled walls 31 extending between the upper and lower plate member surfaces 16, 18. The cavities 30 are narrower at the upper and lower surfaces 16, 18 of the plate than at an intermediate location 34. The diameter of the wall portions 32 are larger at the upper surface 16 than the diameter of the wall portions 32 at the lower plate surface 18, but the diameter of the wall portions 34 is always larger than that at both the upper and lower surfaces 16, 18. The slightly smaller diameter of the wall portions 32 at the lower surface 18 of the plate member 12 keeps the bone screw 14 from slipping through the cavities 30 prior to insertion of the locking member 48 into the central bore 42 of the bone screw 14. The angulation of the wall surfaces 31 between the upper and lower plate surfaces 16, 18 is generally about between 110° to 160°. The cavities 30 of the openings 24, 26 and slots 28 are shaped to allow for a transverse angulation of generally up to about 35° in both directions from the central vertical axis CA of the openings 24, 26 and slots 28 (FIG. 12). The cavities 30 of the openings 24, 26 are shaped to allow for a longitudinal angulation of generally up to about 35° in both directions from the central vertical axis of the openings 24, 26 (FIG. 12). The cavities 30 of the slots 28 are shaped to allow for a longitudinal angulation of generally between 0° to 130° in both directions from the central vertical axis of the slots 28 (FIG. 11 ). The openings 24, 26 and slots 28 have a bevelled surface 15 on the upper and lower plate surfaces 16, 18 as illustrated in FIGS. 4-6. The geometry of the plate member 12, plus the load factors of the openings 24, 26 and slots 28, allow the plate member 12 to be somewhat bendable during implantation while still maintaining the rigidity needed for adequate fixation and immobilization of the vertebrae. Additionally, the transverse curve of the plate member
12 allows it to more closely fit the contours of the vertebrae.
The bone screw 14 has an elongated shank 36, a lower tip 37, and an enlarged upper portion 40 affixed to one end of the shank 36. The lower tip 37 of the bone screw 14 communicates with a helical thread 38 that begins at the lower tip 37 and terminates at the upper portion 40. The enlarged upper portion 40 has a spherically-shaped outer surface 41 , a tapered central bore 42 and upper walls 43. The upper walls 43 of the enlarged portion 40 have at least 2 radial slits 44 intersecting the bore 42, and in a preferred embodiment, four radial slits 44 intersecting the bore 42, as seen in FIG. 9. The central bore 42 includes internal threading 46 on a portion of the frustoconical surface 45, as illustrated in FIGS. 7 and 10. The spherically-shaped surface 41 of the upper portion 40 interfaces with the cavities 30 of the openings 24, 26 and elongated slots 28 (see FIG. 10) as will be described more fully hereinafter.
A locking member 48, as shown in FIG. 8, has lower and upper portions 50, 52 respectively and a top surface 51 , with the locking member 48 being sized and shaped to fit into the tapered central bore 42 of the bone screw 14. The locking member 48 includes external threading 54 on its lower portion 50 which engages the corresponding internal threading 46 of the central bore 42. A tool receptive socket such as hexagonal socket 56 (FIG. 9) is provided on the flat top surface 51 , so that the locking member 48 can be rotated using an alien wrench or other such tool or instrument. When locking member 48 is threaded into the central bore 42 of bone screw 14, the upper walls 43 expand outwardly further enlarging the upper portion 40.
As shown in FIGS. 10-12, the angular shape of the cavity walls 31 allows for both transverse and longitudinal angulation of an implanted bone screw 14. The spherically-shaped surface 41 allows the upper portion 40 of the bone screw 14 to be freely rotatable within the plate member cavity 30 prior to insertion of the locking member 48. After the bone screws 14 have been positioned within the openings 24, 26 and slots 28 of the plate member 12 and implanted in the vertebrae of a patient, the locking members 48 are threaded into the tapered central bore 42 of the bone screws 14. The threading 54 of the locking member 48 engages the threading 46 of the central bore 42 and the radial slits 44 allow the upper wall portions 43 to expand outwardly as the locking member 48 is tightened into the central bore 42 (FIG. 9).
The expanding wall portions 43 grip the cavity walls 31 so as to lock each bone screw 14 into a selected position within the openings 24, 26 and slots 28 of the plate member 12 as illustrated in FIGS. 11 and 12. The locking mechanism between the plate member 12 and the bone screws 14 prevents the implanted bone screws from backing out of the vertebrae. This locking mechanism, plus the geometry of the plate member 12 allows the bone fixation apparatus 10 to provide a rigid construct when initially implanted. However, as the implanted bone screws loosen over time, the bone fixation apparatus 10 becomes semi-rigid and provides a construct that is somewhat flexible and compliant. During implantation, the configuration of the openings 24, 26 provides secure fixation at the ends of the plate member 12 while the slots 28 provide for a variation in screw placement along the longitudinal axis of the plate member 12. The bone fixation apparatus 10 can be sized to be used on cervical or lumbar vertebrae in either an anterior or posterior location. The bone fixation apparatus 10 can also be sized to be used on other bone surfaces in addition to vertebrae.
Although the present invention has been described with reference to its preferred embodiments, those skilled in the art will recognize changes which may be made in form or structure which do not part from the spirit of the invention already described in the specification and embodied in the claims which follow.

Claims

1. A bone fixation apparatus, comprising: a) a plate member having a longitudinal axis, upper and lower surfaces, opposed longitudinal side edges, at least two pairs of circular openings and at least one elongated slot positioned along the longitudinal axis of the plate member; b) said openings and slot each forming a cavity extending between the upper and lower plate member surfaces wherein at least some of said cavities are narrower at the plate member upper and lower surfaces than at a plane located between said surfaces, said openings and slot being shaped to allow for transverse and longitudinal angulation of an implanted bone screw; c) a plurality of bone screws each having a threaded first end portion adapted for implantation into a patient's bone mass and an enlarged second end portion; and d) locking means associated with the second end portion of each bone screw for expanding the second end portion to grip a cavity wall of the plate member and for locking each bone screw into a selected position within at least some of the openings and/or slot of the plate member.
2. An apparatus as claimed in claim 1 , wherein said enlarged second end portion of said bone screws is spherically or part- spherically shaped.
3. An apparatus as claimed in either claim 1 or claim 2, wherein said locking means is adapted to form an interference fit between said second end of said bone screw and a cavity wall of a slot or opening.
4. An apparatus as claimed in any of the preceding claims, wherein the second end portion of each bone screw has a tapered central bore and at least two radial slits intersecting the bore, said central bore including threading on a portion of a surface of the bore.
5. The apparatus of claim 4, wherein each bone screw has four radial slits intersecting the bore.
6. An apparatus as claimed in claim 4, wherein the locking means is sized and shaped to fit into the central bore of each bone screw and has threading on a portion of its surface for engaging the threading on the surface of the bore.
7. An apparatus as claimed in any of the preceding claims, wherein said plate member has a transverse plane and is formed so as to include a curve in the transverse plane.
8. An apparatus as claimed in any of the preceding claims, wherein the plate member further includes a plurality of elongated slots positioned along the longitudinal axis of the plate member.
9. An apparatus as claimed in any of the preceding claims, wherein the plate member has a first end, a second end and a center portion and the distance between said opposed longitudinal side edges is smaller in the region of the center portion than in the region of the first and second ends.
10. An apparatus as claimed in any of the preceding claims, wherein one pair of circular openings is positioned near a first end of the plate member and a second pair of circular openings is positioned near a second end of the plate member.
11. An apparatus as claimed in any of the preceding claims, wherein the openings and slot(s) allow for transverse angulation of said bone screw of up to about 35° in each direction from the central vertical axis of the openings and slot.
12. An apparatus as claimed in any of the preceding claims, wherein the openings allow for longitudinal angulation of up to about 35° in each direction from the central vertical axis of the openings.
13. An apparatus as claimed in any of the preceding claims, wherein the slof(s) allow(s) for longitudinal angulation from about 0° to 130° from the central vertical axis of the slot.
14. An apparatus as claimed in any of the preceding claims, wherein the openings and slot include a bevelled surface on at least one of the upper and lower surfaces of the plate member.
15. An apparatus as claimed in any of the preceding claims, wherein the plate member is of a suitable size to be placed on adjoining cervical vertebrae.
16. An apparatus as claimed in any of the preceding claims, wherein the plate member is of a suitable size to be placed on adjoining lumbar vertebrae.
17. An apparatus as claimed in any of the preceding claims, wherein the plate member is of a suitable size to be placed on an anterior side of the cervical vertebrae.
18. A plate member, adapted for use in a bone fixation apparatus, having upper and lower surfaces, a longitudinal axis, opposed longitudinal side edges, two pairs of circular openings and at least one elongated slot positioned along the longitudinal axis of the plate member; b) said openings and slot each forming a cavity extending between the upper and lower plate member surfaces wherein at least some of said cavities are narrower at the plate member upper and lower surfaces than at a plate located between said surfaces, said openings and slot being shaped to allow for transverse and longitudinal angulation of an implanted bone screw.
19. A plate member as claimed in claim 18, having a transverse plane and being formed so as to include a curve in the transverse plane.
20. A plate member as claimed in either claim 18 or claim 19, wherein the plate member includes a plurality of elongated slots positioned along the longitudinal axis of the plate member.
21. A plate member as claimed in any of claims 18 - 20, wherein the plate member has a first end, a second end and a center portion and the distance between said opposed side edges is smaller in the region of the center portion than in the region of the first and second ends.
22. A plate member as claimed in any of claims 18-21 , wherein one pair of circular openings is positioned near a first end of the plate member and a second pair of circular openings is positioned near the second end of the plate member.
23. A plate member as claimed in any of claims 18 - 22, wherein the openings and slot(s) allow for transverse angulation of said bone screw of up to about 35° in each direction from the central vertical axis of the openings and slot.
24. A plate member as claimed in any of claims 18 - 23, wherein the openings allow for longitudinal angulation of up to about 35° in each direction from the central vertical axis of the openings.
25. A plate member as claimed in any of claims 18 - 24, wherein the slot(s) allow(s) for longitudinal angulation from about 0° to 130° from the central vertical axis of the slots.
26. A plate member as claimed in any of claims 18 - 25, wherein the openings and slot(s) include a bevelled surface on at least one of the upper and lower surfaces of the plate member.
27. A bone screw capable of being locked into a selected position in a plate member, comprising: a) a threaded first end portion adapted for implantation into a patient's bone mass and an enlarged second end portion; and b) locking means associated with the second end portion of the bone screw for expanding the second end portion to grip portions of a wall surface of an opening in a plate member and for locking the bone screw into a selected position within said opening of a plate member.
28. A bone screw as claimed in claim 27, wherein said second end portion is spherical or part-spherical.
29. A bone screw as claimed in either claim 27 or claim 28, wherein said locking means is adapted to form an interference fit between said second end of said bone screw and a cavity wall of an opening or slot formed in a plate member. 16
30. A bone screw as claimed in any of claims 27 - 29, wherein the second end portion has a tapered central bore and at least two radial slits intersecting the bore, said central bore including threading on a portion of a surface of the bore.
31. A bone screw as claimed in claim 30 having four radial slits intersecting the bore.
32. A bone screw as claimed in either claim 30 or claim 31 , wherein the locking means is sized and shaped to fit into the central bore of each bone screw and has threading on a portion of the screw's surface for engaging the threading on the surface of the bore.
PCT/US1995/011681 1994-09-15 1995-09-14 Osteosynthesis apparatus WO1996008206A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
AU39861/95A AU710957B2 (en) 1994-09-15 1995-09-14 Osteosynthesis apparatus
JP8510340A JPH11504227A (en) 1994-09-15 1995-09-14 Osteosynthesis device
CA002199866A CA2199866C (en) 1994-09-15 1995-09-14 Osteosynthesis apparatus

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US30667094A 1994-09-15 1994-09-15
US08/306,670 1994-09-15

Publications (1)

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WO1996008206A1 true WO1996008206A1 (en) 1996-03-21

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Country Status (4)

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JP (1) JPH11504227A (en)
AU (1) AU710957B2 (en)
CA (1) CA2199866C (en)
WO (1) WO1996008206A1 (en)

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EP0809975A2 (en) * 1996-05-31 1997-12-03 Acromed Corporation An apparatus comprising a plate and a fastener for connecting the plate to a bone portion
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WO2000010474A1 (en) * 1998-08-21 2000-03-02 Synthes Ag Chur Bone-anchoring element with snap-in spherical head
EP1006913A1 (en) * 1997-02-11 2000-06-14 MICHELSON, Gary Karlin Anterior cervical plating system, instrumentation, and method of installation
US6383186B1 (en) 1997-02-11 2002-05-07 Gary K. Michelson Single-lock skeletal plating system
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US7118573B2 (en) 2001-06-04 2006-10-10 Sdgi Holdings, Inc. Dynamic anterior cervical plate system having moveable segments, instrumentation, and method for installation thereof
US7186256B2 (en) 2001-06-04 2007-03-06 Warsaw Orthopedic, Inc. Dynamic, modular, single-lock anterior cervical plate system having assembleable and movable segments
US7255699B2 (en) 2001-12-14 2007-08-14 Paul Kamaljit S Spinal plate assembly
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US7763050B2 (en) 2004-12-13 2010-07-27 Warsaw Orthopedic, Inc. Inter-cervical facet implant with locking screw and method
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US7780666B1 (en) 2002-07-05 2010-08-24 Theken Spine, Llc Fixed and variable locking fixation assembly
US7803190B2 (en) 2002-10-29 2010-09-28 Kyphon SÀRL Interspinous process apparatus and method with a selectably expandable spacer
US7833246B2 (en) 2002-10-29 2010-11-16 Kyphon SÀRL Interspinous process and sacrum implant and method
US7909853B2 (en) 2004-09-23 2011-03-22 Kyphon Sarl Interspinous process implant including a binder and method of implantation
EP2323575A1 (en) * 2008-08-07 2011-05-25 K2M, Inc. Bone screw assembly
US7959652B2 (en) 2005-04-18 2011-06-14 Kyphon Sarl Interspinous process implant having deployable wings and method of implantation
US8012209B2 (en) 2004-09-23 2011-09-06 Kyphon Sarl Interspinous process implant including a binder, binder aligner and method of implantation
US8048117B2 (en) 2003-05-22 2011-11-01 Kyphon Sarl Interspinous process implant and method of implantation
USRE42932E1 (en) 2001-01-05 2011-11-15 Stryker France Pedicle screw assembly and methods therefor
US8070778B2 (en) 2003-05-22 2011-12-06 Kyphon Sarl Interspinous process implant with slide-in distraction piece and method of implantation
WO2012010933A1 (en) 2010-07-23 2012-01-26 Ecole Polytechnique Federale De Lausanne (Epfl) Adjustable fixation system for neurosurgical devices
US8480716B2 (en) 2008-04-25 2013-07-09 Pioneer Surgical Technology, Inc. Bone plate system
US8512380B2 (en) 2002-08-28 2013-08-20 Warsaw Orthopedic, Inc. Posterior fixation system
US8623062B2 (en) 2008-09-29 2014-01-07 Dimitriy G. Kondrashov System and method to stablize a spinal column including a spinolaminar locking plate
US8900277B2 (en) 2004-02-26 2014-12-02 Pioneer Surgical Technology, Inc. Bone plate system
US9044277B2 (en) 2010-07-12 2015-06-02 DePuy Synthes Products, Inc. Pedicular facet fusion screw with plate
US9198769B2 (en) 2011-12-23 2015-12-01 Pioneer Surgical Technology, Inc. Bone anchor assembly, bone plate system, and method
US9381046B2 (en) 2007-07-03 2016-07-05 Pioneer Surgical Technology, Inc. Bone plate system
US9655665B2 (en) 2007-07-03 2017-05-23 Pioneer Surgical Technology, Inc. Bone plate systems
US11877779B2 (en) 2020-03-26 2024-01-23 Xtant Medical Holdings, Inc. Bone plate system

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EP0874595A1 (en) * 1995-12-20 1998-11-04 Surgical Dynamics, Inc. Osteosynthesis apparatus
EP0874595A4 (en) * 1995-12-20 2000-04-26 Surgical Dynamics Inc Osteosynthesis apparatus
EP0809975A2 (en) * 1996-05-31 1997-12-03 Acromed Corporation An apparatus comprising a plate and a fastener for connecting the plate to a bone portion
EP0809974A3 (en) * 1996-05-31 1998-04-15 Acromed Corporation An apparatus for retaining bone portions in a desired spatial relationship
EP0809975A3 (en) * 1996-05-31 1998-04-15 Acromed Corporation An apparatus comprising a plate and a fastener for connecting the plate to a bone portion
EP0809974A2 (en) * 1996-05-31 1997-12-03 Acromed Corporation An apparatus for retaining bone portions in a desired spatial relationship
US7955356B2 (en) 1997-01-02 2011-06-07 Kyphon Sarl Laterally insertable interspinous process implant
US7918877B2 (en) 1997-01-02 2011-04-05 Kyphon Sarl Lateral insertion method for spinous process spacer with deployable member
US7828822B2 (en) 1997-01-02 2010-11-09 Kyphon SÀRL Spinous process implant
US7758619B2 (en) 1997-01-02 2010-07-20 Kyphon SÀRL Spinous process implant with tethers
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US6936051B2 (en) 1997-02-11 2005-08-30 Gary K. Michelson Multilock anterior cervical plating system
US6916320B2 (en) 1997-02-11 2005-07-12 Gary K. Michelson Anterior cervical plate system
US6398783B1 (en) 1997-02-11 2002-06-04 Sulzer Spine-Tech Inc. Multi-lock anterior cervical plate
US6416528B1 (en) 1997-02-11 2002-07-09 Gary K. Michelson Anterior cervical plating system, instrumentation, and method of installation
US6428542B1 (en) 1997-02-11 2002-08-06 Gary K. Michelson Single-lock anterior cervical plate
EP1006913A4 (en) * 1997-02-11 2001-10-31 Michelson Gary K Anterior cervical plating system, instrumentation, and method of installation
US6454771B1 (en) 1997-02-11 2002-09-24 Gary K. Michelson Anterior cervical plating system
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US6527776B1 (en) 1997-02-11 2003-03-04 Gary K. Michelson Locking element for locking at least two bone screws to an orthopedic device
US6592586B1 (en) 1997-02-11 2003-07-15 Gary K. Michelson Single-lock anterior cervical plating system
US6616666B1 (en) 1997-02-11 2003-09-09 Gary K. Michelson Apparatus for compressing a spinal disc space disposed between two adjacent vertebral bodies of a cervical spine
US6620163B1 (en) 1997-02-11 2003-09-16 Gary K. Michelson Anterior cervical plating system and bone screw
US7137984B2 (en) 1997-02-11 2006-11-21 Warsaw Orthopedic, Inc. Single-lock anterior cervical plate and method
US7077844B2 (en) 1997-02-11 2006-07-18 Sdgi Holdings, Inc. Segmentable skeletal plating system
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US6926718B1 (en) 1997-02-11 2005-08-09 Gary K. Michelson Multilock anterior cervical plating system
US6383186B1 (en) 1997-02-11 2002-05-07 Gary K. Michelson Single-lock skeletal plating system
US6936050B2 (en) 1997-02-11 2005-08-30 Gary K. Michelson Multilock anterior cervical plating system
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FR2763828A1 (en) * 1997-05-29 1998-12-04 Aesculap Jbs Osteosynthesis plate for spinal surgery
US6706043B2 (en) 1998-08-21 2004-03-16 Synthes (U.S.A.) Self-cutting, hollow-cylindrical bone anchoring assembly
WO2000010474A1 (en) * 1998-08-21 2000-03-02 Synthes Ag Chur Bone-anchoring element with snap-in spherical head
AU747042B2 (en) * 1998-08-21 2002-05-09 Synthes Gmbh Bone-anchoring element with snap-in spherical head
US6508818B2 (en) 1998-08-21 2003-01-21 Synthes (U.S.A.) Bone anchoring assembly with a snap-in ballhead
US7699872B2 (en) 2000-09-15 2010-04-20 Warsaw Orthopedic, Inc. Posterior fixation system
WO2002022030A3 (en) * 2000-09-15 2002-09-06 Sdgi Holdings Inc Posterior fixation system
USRE42932E1 (en) 2001-01-05 2011-11-15 Stryker France Pedicle screw assembly and methods therefor
US8894692B2 (en) 2001-01-05 2014-11-25 Stryker France Pedicle screw assembly and methods therefor
US6702817B2 (en) 2001-01-19 2004-03-09 Aesculap Ag & Co. Kg Locking mechanism for a bone screw
US7172600B2 (en) 2001-01-19 2007-02-06 Aesculap Ag & Co. Kg Locking mechanism for a bone screw
US7118573B2 (en) 2001-06-04 2006-10-10 Sdgi Holdings, Inc. Dynamic anterior cervical plate system having moveable segments, instrumentation, and method for installation thereof
US7186256B2 (en) 2001-06-04 2007-03-06 Warsaw Orthopedic, Inc. Dynamic, modular, single-lock anterior cervical plate system having assembleable and movable segments
US8834533B2 (en) 2001-06-04 2014-09-16 Warsaw Orthopedic, Inc. Dynamic plate system having moveable segments
US7097645B2 (en) 2001-06-04 2006-08-29 Sdgi Holdings, Inc. Dynamic single-lock anterior cervical plate system having non-detachably fastened and moveable segments
US7044952B2 (en) 2001-06-06 2006-05-16 Sdgi Holdings, Inc. Dynamic multilock anterior cervical plate system having non-detachably fastened and moveable segments
US7255699B2 (en) 2001-12-14 2007-08-14 Paul Kamaljit S Spinal plate assembly
US7785327B1 (en) 2002-07-05 2010-08-31 Theken Spine, Llc Fixed and variable locking fixation assembly
US7780666B1 (en) 2002-07-05 2010-08-24 Theken Spine, Llc Fixed and variable locking fixation assembly
US8512380B2 (en) 2002-08-28 2013-08-20 Warsaw Orthopedic, Inc. Posterior fixation system
US7803190B2 (en) 2002-10-29 2010-09-28 Kyphon SÀRL Interspinous process apparatus and method with a selectably expandable spacer
US7833246B2 (en) 2002-10-29 2010-11-16 Kyphon SÀRL Interspinous process and sacrum implant and method
US7695513B2 (en) 2003-05-22 2010-04-13 Kyphon Sarl Distractible interspinous process implant and method of implantation
US8070778B2 (en) 2003-05-22 2011-12-06 Kyphon Sarl Interspinous process implant with slide-in distraction piece and method of implantation
US8048117B2 (en) 2003-05-22 2011-11-01 Kyphon Sarl Interspinous process implant and method of implantation
US7309340B2 (en) 2003-06-20 2007-12-18 Medicinelodge, Inc. Method and apparatus for bone plating
US7740649B2 (en) 2004-02-26 2010-06-22 Pioneer Surgical Technology, Inc. Bone plate system and methods
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US8012209B2 (en) 2004-09-23 2011-09-06 Kyphon Sarl Interspinous process implant including a binder, binder aligner and method of implantation
US7909853B2 (en) 2004-09-23 2011-03-22 Kyphon Sarl Interspinous process implant including a binder and method of implantation
US7763050B2 (en) 2004-12-13 2010-07-27 Warsaw Orthopedic, Inc. Inter-cervical facet implant with locking screw and method
US8100944B2 (en) 2004-12-13 2012-01-24 Kyphon Sarl Inter-cervical facet implant and method for preserving the tissues surrounding the facet joint
US7776090B2 (en) 2004-12-13 2010-08-17 Warsaw Orthopedic, Inc. Inter-cervical facet implant and method
US7931674B2 (en) 2005-03-21 2011-04-26 Kyphon Sarl Interspinous process implant having deployable wing and method of implantation
US7749252B2 (en) 2005-03-21 2010-07-06 Kyphon Sarl Interspinous process implant having deployable wing and method of implantation
US7959652B2 (en) 2005-04-18 2011-06-14 Kyphon Sarl Interspinous process implant having deployable wings and method of implantation
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US8623062B2 (en) 2008-09-29 2014-01-07 Dimitriy G. Kondrashov System and method to stablize a spinal column including a spinolaminar locking plate
US9044277B2 (en) 2010-07-12 2015-06-02 DePuy Synthes Products, Inc. Pedicular facet fusion screw with plate
US9089372B2 (en) 2010-07-12 2015-07-28 DePuy Synthes Products, Inc. Pedicular facet fusion screw with plate
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US10159514B2 (en) 2011-12-23 2018-12-25 Pioneer Surgical Technology, Inc. Method of implanting a bone plate
US9198769B2 (en) 2011-12-23 2015-12-01 Pioneer Surgical Technology, Inc. Bone anchor assembly, bone plate system, and method
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CA2199866A1 (en) 1996-03-21
AU710957B2 (en) 1999-09-30
CA2199866C (en) 2006-08-29
AU3986195A (en) 1996-03-29
JPH11504227A (en) 1999-04-20

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