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Artificial intervertebral disc

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Publication number
US20050165487A1
US20050165487A1 US10766684 US76668404A US2005165487A1 US 20050165487 A1 US20050165487 A1 US 20050165487A1 US 10766684 US10766684 US 10766684 US 76668404 A US76668404 A US 76668404A US 2005165487 A1 US2005165487 A1 US 2005165487A1
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Prior art keywords
disc
body
surface
articulating
concave
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
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US10766684
Inventor
Nabil Muhanna
Lance Middleton
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F3 TECHNOLOGIES LLC
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Muhanna Nabil L.
Middleton Lance M.
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442Intervertebral or spinal discs, e.g. resilient
    • A61F2/4425Intervertebral or spinal discs, e.g. resilient made of articulated components
    • 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
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/7004Longitudinal elements, e.g. rods with a cross-section which varies along its length
    • A61B17/7007Parts of the longitudinal elements, e.g. their ends, being specially adapted to fit around the screw or hook heads
    • 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
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/701Longitudinal elements with a non-circular, e.g. rectangular, cross-section
    • AHUMAN NECESSITIES
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
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    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108Shapes
    • A61F2002/30199Three-dimensional shapes
    • A61F2002/30301Three-dimensional shapes saddle-shaped
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30331Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
    • A61F2002/30362Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit with possibility of relative movement between the protrusion and the recess
    • A61F2002/30364Rotation about the common longitudinal axis
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30331Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
    • A61F2002/30362Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit with possibility of relative movement between the protrusion and the recess
    • A61F2002/30369Limited lateral translation of the protrusion within a larger recess
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30462Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements retained or tied with a rope, string, thread, wire or cable
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30476Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
    • A61F2002/30507Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism using a threaded locking member, e.g. a locking screw or a set screw
    • AHUMAN NECESSITIES
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external and/or bone-contacting surfaces, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external and/or bone-contacting surfaces, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes, grooves
    • A61F2002/30878Special external and/or bone-contacting surfaces, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes, grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30879Ribs
    • A61F2002/30883Ribs dovetail-shaped
    • AHUMAN NECESSITIES
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external and/or bone-contacting surfaces, e.g. coating for improving bone ingrowth
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    • A61F2002/30878Special external and/or bone-contacting surfaces, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes, grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30884Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
    • AHUMAN NECESSITIES
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0033Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
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    • A61F2220/0075Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
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Abstract

An artificial intervertebral disc for at least partially replacing a diseased or damaged intervertebral disc. The artificial disc includes a concave-convex articulating surface. The artificial disc can be used in the cervical region of the spine, where a concave-convex articulating surface is advantageous for improved anatomical fit and region appropriate kinematics. The artificial disc of the present invention also includes an anchor for attachment to bone.

Description

    FIELD OF THE INVENTION
  • [0001]
    The present invention generally relates to an apparatus for the treatment of spinal disorders and, in particular, an artificial intervertebral disc, an implant that replaces a diseased or damaged intervertebral disc.
  • BACKGROUND OF THE INVENTION
  • [0002]
    There are many painful disorders of the spine, many relating, at least in part, to diseased or damaged intervertebral discs. Disorders include Degenerative Disc Disease, generally an age related disorder where the intervertebral disc gradually loses its water content, resiliency, and height. With a loss in intervertebral disc height and associated loss of normal spacing between vertebrae, motion of the vertebrae can place pressure on the spinal cord or exiting nerve roots. The intervertebral disc itself can also be a source of pain. Spinal disorders, commonly referred to as disc herniation and bulging disc, place painful pressure on the spinal cord and exiting nerve roots. Abnormal bone growth, called osteophytes, can place pressure on nerves or the spinal cord. Often, a surgeon must at least partially remove an intervertebral disc to access and remove an osteophyte.
  • [0003]
    A surgical approach to treating chronic spinal disorders relates to bony fusion of two adjacent vertebrae in a treatment called spine fusion. Following the achievement of appropriate spacing and alignment of the vertebral bodies, bone graft material and stabilization provide an environment for spine fusion. Implant systems, to include plate and rod systems and interbody devices, such as, interbody spacers and fusion cages can be used to support the spine during fusion. Concerns persist regarding spinal fusion treatment stemming from modest clinical success rates and the creation of rigid regions along an otherwise flexible spine.
  • [0004]
    Artificial intervertebral discs, or simply artificial discs, are an alternative to spinal fusion and represent an emerging technology. These spinal implants are designed to restore or maintain the appropriate alignment and spacing of adjacent vertebral bodies. In addition, an artificial disc is also designed for kinematic behavior similar to a healthy natural disc. Known artificial disc concepts use numerous means for providing motion and stiffness similar to a natural healthy disc, to include the adaptation of elastomers, mechanical springs, and articulating surfaces.
  • [0005]
    Prior art artificial discs often use articulating surfaces to create a joint between adjacent vertebrae. Disc implants using articulating surfaces rely on methodology and proven technology used in total joint arthroplasty of the hip, knee, and shoulder. Numerous prior art artificial discs resemble artificial hip and artificial knee joints. Numerous known artificial disc devices resemble variations of a ball-and-socket. Kuntz, in U.S. Pat. No. 4,349,921 (Sep. 21, 1982) discloses an artificial disc, with two components that articulate by means of a projection on one component pivotally engaging a depression on the second component. An artificial disc resembling an artificial knee joint has also been suggested. Shelokov, in U.S. Pat. No. 6,039,763 (Mar. 21, 2000) discloses an artificial spinal disc, similar in configuration to an artificial knee joint.
  • [0006]
    Heggeness et. al., in U.S. Pat. No. 5,514,180 (May 1996) categorizes the shape or contours of vertebral endplates into five groups: “ramp”, “saddle”, “irregular”, “bowl”, and “hump”. Heggeness et. al., teaches the importance of endplate shape relating to fit and load distribution of a prosthetic devices within intervertebral disc spaces, but Heggeness et. al. does not discuss endplate shape relating to articulating surfaces or spinal kinematics.
  • [0007]
    Spine kinematics and anatomical shapes vary by region of the spine (cervical, thoracic, and lumbar), and a need exists for artificial discs addressing specific regions of the spine, especially the unique geometry and kinematics of the cervical spine.
  • SUMMARY OF THE INVENTION
  • [0008]
    For the middle and lower regions of the cervical spine, the artificial disc of the present invention adapts an articulating surface with a concave-convex shape, also called a saddle shape. The artificial disc of the present invention is intended to fit substantially within the intervertebral space bound by adjacent vertebral bodies. A bone anchor for fixation of an artificial disc to vertebra is also disclosed.
  • [0009]
    A first embodiment of the artificial disc of the present invention for the cervical spine includes a disc body having an articulating concave-convex surface secured to a base plate, which may incorporate a bone anchor. A second embodiment of the artificial disc of the present invention is comprised of an articulating concave-convex surface, bone anchor, and a disc body slidably attached to a base plate to permit additional motion. A third embodiment of the artificial disc of the present invention includes an upper disc body and a lower disc body cooperatively forming a saddle-joint. The upper disc body and lower disc body of the third embodiment are securely anchored to vertebral bodies using bone anchors. Further embodiments of the artificial disc of the present invention include an upper disc body and a lower disc body cooperatively forming a saddle-joint, and bone anchors adapted with a tension element to provide additional stability.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • [0010]
    FIG. 1 shows a frontal view of a cervical spine motion segment comprised of two vertebrae and an intervertebral disc.
  • [0011]
    FIG. 2A shows a cervical vertebra in a perspective view of the superior endplate.
  • [0012]
    FIG. 2B shows an alternate perspective view of the cervical vertebra shown in FIG. 1A to emphasize the inferior endplate.
  • [0013]
    FIG. 3 shows a first preferred embodiment artificial disc of the present invention for the cervical spine with an articulating concave-convex surface.
  • [0014]
    FIG. 4A, FIG. 4B, and FIG. 4C show the artificial disc depicted in FIG. 3 in orthogonal views to include a front view, side view, and top view, respectively.
  • [0015]
    FIG. 5 shows the artificial disc depicted in FIG. 3 in an exploded view to include adjacent vertebrae of the cervical spine.
  • [0016]
    FIG. 6 shows a midsagittal sectional view of the first preferred embodiment artificial disc of the present invention depicted in FIG. 3 between adjacent cervical vertebrae.
  • [0017]
    FIG. 7 shows a midsagittal sectional view of a first preferred embodiment artificial disc of the present invention depicted in FIG. 3 with a schematic of Instantaneous-Axis-of-Rotation (IAR) of a superior vertebra in flexion.
  • [0018]
    FIG. 8 shows a second preferred embodiment artificial disc of the present invention with a disc body slidably attached to a base plate to permit rotational and translational sliding.
  • [0019]
    FIG. 9 shows a third preferred embodiment artificial disc of the present invention to include an upper disc body and a lower disc body cooperatively forming a saddle-joint with concave-convex surfaces.
  • [0020]
    FIG. 10 shows a fourth preferred embodiment artificial disc of the present invention to include an upper disc body and a lower disc body cooperatively forming a saddle-joint with concave-convex surfaces and a tension cable.
  • [0021]
    FIG. 11 shows a fifth preferred embodiment artificial disc of the present invention to include an upper disc body and a lower disc body cooperatively forming a saddle-joint with concave-convex surfaces and a flexible plate.
  • [0022]
    FIG. 12 shows a sixth preferred embodiment artificial disc of the present invention with an upper articulating concave-convex surface and a lower articulating surface.
  • DETAILED DESCRIPTION
  • [0023]
    Consistent with common medical nomenclature, superior is nearer the head in relation to a specific reference point, whereas, inferior is nearer the feet in relation to a specific reference point. Anterior is forward in relation to a specific reference point and posterior is rearward in relation to a specific reference point. The midsagittal plane is an imaginary plane dividing the body into a right side and left side. A frontal plane is any imaginary vertical plane orthogonal to the midsagittal plane.
  • [0024]
    FIG. 1 shows a cervical spinal motion segment 1 characteristic of the middle and lower cervical spine comprised of a superior vertebra 10, an intervertebral disc 7, and an inferior vertebra 10′. Superior vertebra 10 is divided into two regions to include superior vertebral body 11 and superior posterior elements 17. Similarly, inferior vertebra 10′ is divided into two regions to include inferior vertebral body 11′ and inferior posterior elements 17′. Although separated by the intervertebral disc 7 to permit motion, the superior vertebral body 11 and the inferior vertebral body 11′ are anatomically interlocking due to the reciprocal reception of the generally saddle-shaped inferior endplate 23 of the superior vertebral body 11 with the superior endplate 13′ of inferior vertebral body 11′. Although the spinal motion segments are not a synovial joint, the most closely related synovial joint to the middle and lower cervical spine motion segments is the carpometacarpal joint of the thumb, which is formed by articulating surfaces in the form of a saddle-joint. In contrast, the vertebral bodies of other regions of the spine (thoracic and lumbar) are not anatomically interlocking.
  • [0025]
    FIG. 2A and FIG. 2B show cervical vertebra 10 of FIG. 1 viewed at different perspectives to highlight superior endplate 13 and inferior endplate 23, respectively. Consistent with established medical nomenclature, cervical vertebra 10 includes vertebral body 11, and the bony structures attached to vertebral body 11 are posterior elements 17. The superior endplate 13 is generally concave, or at least partially concave, as indicated by the superior frontal surface line 14. The superior midsagittal surface line 15 is substantially straight but may be slightly concave or convex, or at least partially concave or convex. The inferior concave-convex endplate 23 is substantially convex in the medial-lateral direction and substantially concave in the anterior/posterior direction to form a saddle surface, as indicated by inferior convex surface line 24 and inferior concave surface line 25.
  • [0026]
    Primarily addressing the middle and lower cervical spine, the present invention uses a generally concave-convex articulating surface. As will become apparent in subsequent discussion, a concave-convex articulating surface is an essential element of the present invention, providing anatomical and biomechanical advantages. Referring now to FIG. 3, a first preferred embodiment, artificial disc 100, is comprised of a disc body 130, base plate 138, and bone anchor 150. Concave-convex articulating surface 133 is further revealed by considering two example reference lines formed from convenient planer reference planes, concave surface line 134 and midsagittal convex surface line 135. The curvature of concave-convex articulating surface 133 may be formed of simple radii or variable radii, and may be further expressed mathematically, at least in part, as a hyperbolic paraboloid, saddle-surface, or surface with negative curvature As will become apparent in subsequent discussion, a concave-convex articulating surface is an essential element of the present invention, providing anatomical and biomechanical advantages. Disc body 130 and base plate 138 are shown as separate components, although manufacture as a single component is also contemplated. Disc body 130 has a height appropriate for spacing of the vertebral bodies and may be of various shapes and sizes in order to substantially fill the surgically prepared space between vertebral bodies. Base plate 138 may have planer surfaces and uniform thickness, as shown in FIG. 3, although variable thickness and curved surfaces are also contemplated. Bone anchor 150 and base plate 138 are adapted for fixation to bone. Bone anchor 150 is comprised of vertical anchor web 152, anchor body 154, and anchor hole 156. As shown in FIG. 3, vertical anchor web 152 has a vertical height greater than width. In addition, vertical anchor web 152 may take other various forms, to include, but not be limited to, a web with variable thickness. Anchor body 154 is a protuberance with a width substantially greater than the thickness of vertical anchor web 152. As shown in FIG. 3, anchor body 154 is cylindrical, but other shapes are also contemplated, to include, but not limited to, a box shape. A use of anchor hole 156 is to releasably attach a surgical instrument during insertion of artificial disc 100. FIG. 4A, FIG. 4B, and FIG. 4C show artificial disc 100 in orthogonal views to include a front view, side view, and top view, respectively
  • [0027]
    FIG. 5 shows the first preferred embodiment artificial disc 100 of the present invention depicted in FIG. 3 in an exploded perspective view between superior cervical vertebra 110 and inferior cervical vertebra 110′. Inferior vertebral body 111′ includes a surgically created vertebral body key-hole 128′ intended to receive bone anchor 150. Bone anchor 150 provides secure interlocking fixation with inferior vertebral body 111′ and requires a minimal amount of bone removal.
  • [0028]
    FIG. 6 shows a midsagittal sectional view of the first preferred embodiment artificial disc 100 depicted in FIG. 3 between superior cervical vertebra 110 and inferior cervical vertebra 110′. Superior vertebra 110 is comprised of superior vertebral body 111 and superior posterior elements 117. Similarly, inferior vertebra 110′ is divided into two regions to include inferior vertebral body 111′ and inferior posterior elements 117′. Concave-convex articulating surface 133 is intended to slide with respect to inferior concave-convex endplate 123 provided the cartilaginous inferior concave-convex endplate 123 remains substantially intact following treatment of the patient's pathology. The contour of concave-convex articulating surface 133 is substantially similar to the contour of inferior concave-convex endplate 123, although some mismatch and variability is expected. It is expected that a patient's endplate can modify and generally adapt to the shape of an implant during healing. Bone anchor 150 is positioned within vertebral body key-hole 128′. Base plate 138 may have additional features for bony in-growth into inferior vertebral body 111′ through the use of established porous materials or surface treatments. The anatomically aligned shape of artificial disc 100 results in a near complete fill of the intervertebral disc space; the resulting construct is substantially free of large voids that are potentially susceptible to eventual tissue encroachment. Significant tissue encroachment into an artificial disc could potentially interfere with movement of an artificial disc. Finally, the anatomically aligned shape of artificial disc 100 is intended to fit within the intervertebral disc space with minimal bone removal and endplate preparation during surgery, reducing surgical time and preserving otherwise healthy tissue.
  • [0029]
    The anatomically aligned shape of the present invention also has biomechanical benefits associated with natural kinematics of the spine. To assist with the analysis of spine kinematics, Panjabi and White established the Instantaneous-Axis-of-Rotation (IAR) for planer motion analysis of vertebrae. Planar motion of vertebrae is fully described by the position of the IAR and the angle of rotation about the IAR. The IAR is an instantaneous measure and therefore may shift within a region through a range-of-motion, such as, but not limited to, flexion/extension range-of-motion. The present inventors have discovered a relation between the shape of a vertebra's inferior endplate and the natural motion of the same vertebra.
  • [0030]
    Flexion/extension is the most commonly considered degree-of-freedom when evaluating cervical spine kinematics. FIG. 7 shows the first preferred embodiment, artificial disc 100 depicted in FIG. 3, in a midsagittal sectional view between superior vertebra 110 and inferior vertebra 110′. Superior vertebra 110 is shown in a neutral position with locator point A1 and locator point B1 and in a flexed position with locator point A2 and locator point B2. Locator points may be any two unique points on a vertebra, and convenient anatomical landmarks are often used for these reference points. The selected frame of reference is inferior vertebra 110′, so the instantaneous-axis-of-rotation IAR is of superior vertebra 110 with respect to inferior vertebrae 110′. Continuing to refer to FIG. 7, instantaneous-axis-of-rotation IAR is established by determining the intersection of line LA and line LB, where line LA and line LB are bisected normal lines of translation vector A1A2 and translation vector B1B2, respectively. Concave-convex articulating surface 133 has been adapted to have a substantially similar shape to inferior concave-convex endplate 123. Continuing to refer to FIG. 7, inferior concave-convex endplate 123 sliding with respect to concave-convex articulating surface 133 establishes the motion in flexion. The general region of Instantaneous-Axis-of-Rotation IAR is within the posterior region of inferior vertebral body 111′. Concerning the middle and lower cervical spine, the Instantaneous-Axis-of-Rotation IAR in flexion/extension of artificial disc 100, shown in FIG. 7, is consistent with recent scientific research demonstrating the IAR of a superior vertebra in flexion/extension generally lay within a posterior region of an inferior vertebral body (DiAngelo et. al., proceedings of Cervical Spine Research Society Meeting 2000). Further, the mathematical equations defining the shape of concave-convex articulating surface 133, generally in the form of a hyperbolic paraboloid, can be developed to substantially replicate the complex natural motions of the spine, to include, but not limited to, flexion/extension, lateral bending, and torsional motion.
  • [0031]
    Within the scope of the present invention, multiple components may be allowed to articulate to address multiple degrees-of-freedom associated with spinal motion, to include, but not limited to, torsional and translational degrees-of-freedom. Accordingly,
  • [0032]
    FIG. 8 shows a second preferred embodiment of the present invention, artificial disc 200 in an exploded perspective view. Artificial disc 200 is comprised of a disc body 230, concave-convex articulating surface 233, base plate 238, and bone anchor 250. Bone anchor 250 is comprised of vertical web 252 and anchor body 254. Base plate protrusion 240 inserts into disc body socket 236, while disc body articulating surface 237 and base plate articulating surface 239 allow sliding rotation of disc body 230 about axis X-X 245. Alternately, disc body socket 236 may take various shapes and sizes relative to base plate protrusion 240 to allow planer translation between disc body 230 and base plate 238. For example, disc body socket 236 may take the form of an elongated slot. Although, disc body articulating surface 237 and base plate articulating surface 239 are shown as planer surfaces, curved surfaces are also contemplated. A cylindrical shape for base plate protrusion 240 is shown in FIG. 8, however, other shapes are also envisioned within the scope of the present invention.
  • [0033]
    For a number of reasons, to include anatomical variation, the inferior endplate of a superior vertebra may not be suitable as an articulating surface. During treatment of a cervical spine disorders, endplates are often partially or completely removed in order to access and remove offending soft tissue (e.g., extruded disc nucleus) or offending hard tissue (e.g., posterior bone spurs). A total joint artificial disc is often warranted. Accordingly, FIG. 9 shows a third preferred embodiment of the present invention, artificial disc 300, comprised of lower disc body 330 and upper disc body 370. Lower disc body 330, attached to lower base plate 338, has a lower body concave-convex articulating surface 333. Lower bone anchor 350 is comprised of lower vertical web 352 and lower anchor body 354. Upper disc body 370 is comprised of upper base plate 378, upper body concave-convex articulating surface 373, and upper bone anchor 380. Upper bone anchor 380 is comprised of upper vertical web 382 and upper anchor body 384. Lower anchor hole 356 and upper anchor hole 386 can be used to releasably attach a surgical instrument during implantation of artificial disc 300. Lower body concave-convex articulating surface 333 is further defined by concave surface line 334 and midsagittal convex surface line 335. Lower base plate 338 and lower bone anchor 350 are adapted for fixation to an inferior vertebra. Similarly, upper bone anchor 380, comprised of upper vertical anchor web 382 and upper anchor body 384 are adapted for body fixation to a vertebra. The reciprocal reception of lower body concave-convex articulating surface 333 with upper body concave-convex articulating surface 373 forms a saddle-joint. The complement of lower body concave surface line 334 is upper body convex surface line 374, and the complement of lower body convex surface line 335 is upper body concave surface line 375. Surface contours of lower body concave-convex articulating surface 333 and upper body concave-convex articulating surface 373 may be dimensionally matched. Or, surface contours of lower body concave-convex articulating surface 333 and upper body concave-convex articulating surface 373 may be cooperatively aligned, but dimensionally mismatched to give the saddle-joint additional freedom (“toggle”) or to establish selected regions of surface contact within manufacturing tolerances. A “gentle braking” occurs in torsion between the lower disc body 330 and the upper disc body 370 as the lower body concave-convex articulating surface 333 and upper body concave-convex articulating surface 373 interact during a torsional motion away from a neutral position, reflecting a more natural resistance to torsional loading. In addition, the surface geometry defining the articulating interaction of lower body concave-convex articulating surface 333 and upper body concave-convex articulating surface 373 may be developed to substantially replicate the complex natural motions of the spine, to include, but not limited to, flexion/extension, lateral bending, and torsional motion.
  • [0034]
    Using an anterior approach to the cervical spine, the anterior longitudinal ligament is at least partially resected with associated loss of stability, especially in extension. An artificial disc with a tension element provides stability during extension. Referring now to FIG. 10, a fourth preferred embodiment is shown, artificial disc 400, comprised of lower disc body 430 and upper disc body 470. Lower disc body 430 is joined to lower base plate 438. Lower disc body 430 is also comprised of a lower body concave-convex articulating surface 433. Lower bone anchor 450, comprised of lower vertical web 452 and lower anchor body 454, is adapted for fixation to bone. Upper disc body 470 comprised of upper base plate 478, upper body concave-convex articulating surface 473 and upper bone anchor 480. Upper bone anchor 480 is comprised of upper vertical web 482 and upper anchor body 484. One use of lower anchor hole 456 and upper anchor hole 486 is to releasably attach a surgical instrument during insertion of artificial disc 400. A saddle-joint is formed by the reciprocal reception of lower body concave-convex articulating surface 433 with upper body concave-convex articulating surface 473. Tension cable 490, to include cable knot 491, is secured through the lower anchor eyelet 458 and the upper anchor eyelet 488. Tension cable 490 provides additional stability, restricting motion, especially during extreme extension.
  • [0035]
    FIG. 11 shows a fifth preferred embodiment, artificial disc 500, comprised of lower disc body 530 and upper disc body 570. Lower disc body 530 includes lower body concave-convex articulating surface 533. Lower disc body 530 is attached to lower base plate 538. Lower bone anchor 550, adapted for interlocking connection to bone, is comprised of lower vertical web 552 and lower anchor body 554. Upper disc body 570 is comprised of upper base plate 578 and upper body concave-convex articulating surface 573. Upper bone anchor 580 is comprised of upper vertical web 582 and upper anchor body 584. The reciprocal reception of lower body concave-convex articulating surface 533 with upper body concave-convex articulating surface 573 forms a saddle-joint. Flexible plate 590 is secured to lower anchor body 550 and upper anchor body 580 by lower fastener 594′ and upper fastener 594, respectively. Flexible plate 590 is intended to provide greater stability in extension. To allow specified range-of-motion in extension and flexion where flexible plate 590 is not substantially under load, lower fastener 594′ and upper fastener 594 are intended to slide with respect to lower plate slot 592′ and upper plate slot 592, respectively.
  • [0036]
    Within the scope of the current invention, an artificial disc may have an upper articulating surface and a lower articulating surface for sliding interaction with vertebral bodies. FIG. 12 shows a sixth preferred embodiment, artificial disc 600, comprised of disc body 630, upper articulating concave-convex surface 633 and lower articulating surface 673. Curvature of upper articulating concave-convex surface 633 is further defined by concave surface line 634 and midsagittal convex surface line 635. Lower surface line 674 is at least generally convex and lower midsagittal plane surface line 675 is generally straight, but may also have curvature.
  • [0037]
    The present invention, to include, but not limited to the aforementioned embodiments, can be constructed of established orthopaedic materials. Established wear resistant materials for components with articulating surfaces include metals (e.g., stainless-steel, cobalt-chrome, and titanium), plastics (e.g., Ultra-High-Molecular-Weight-Polyethylene), and ceramics (e.g., alumina and zironia). Non-articulating features of an artificial disc of the present invention may have features or material characteristics to facilitate rigid attachment to bone. An artificial disc of the present invention may be adapted additional features known for attachment to bone including, but not limited to, spikes, screws, serration, and plate-like appendages generally exterior to the intervertebral disc space. Components may be made, in part, constructed of substantially porous materials for bone in-growth, yet have smooth non-porous regions for articulating surfaces. Surface treatments commonly practiced, such as beaded-coatings, may also be used for attachment to bone through eventual bone in-growth. In addition, within the scope of the current invention, components may be given flexibility through the use of geometry and materials to replicate the cushioning characteristics of the natural intervertebral disc. Additional components, such as, springs might be added to provide flexibility. In addition, portions of the patient's annulus may remain intact, such that the present invention augments a patient's existing intervertebral disc. Although the utility of the disclosed artificial disc is best achieved in the cervical region of the spine, adaptations for the thoracic and lumbar regions of the spine are also within the scope and spirit of the present invention.

Claims (18)

1. A prosthetic disc comprising:
A disc body, having a disc body base surface having a center point having a base surface central normal vector extending therefrom; and a disc body articulating surface opposite the disc body base surface, the articulating surface being concave with respect to a first disc body plane parallel to the base plate central normal vector, and being convex with respect to a second disc body plane, parallel to the base plate central normal vector and orthogonal to the first disc body plane.
2. The prosthetic disc of claim 1 wherein the second disc body plane is the midsagittal plane.
3. The prosthetic disc of claim 1 wherein the curve of the articulating surface in the first disc body plane is parabolic.
4. The prosthetic disc of claim 1 wherein the curve of the articulating surface in the first disc body plane is hyperbolic.
5. The prosthetic disc of claim 1 wherein the curve of the articulating surface in the first disc body plane follows a radius.
6. The prosthetic disc of claim 1 wherein the curve of the articulating surface in the second disc body plane is parabolic.
7. The prosthetic disc of claim 1 wherein the curve of the articulating surface in the second disc body plane is hyperbolic.
8. A prosthetic disc comprising:
A disc body, having a disc body base surface and a disc body articulating surface opposite the disc body surface, wherein at least a substantial region of said disc body articulating surface is concave-convex.
9. The prosthetic disc of claim 9 wherein the disc body articulating surface is a hyperbolic paraboloid.
10. The prosthetic disc of claim 9 wherein the curve of the articulating surface in a first disc body plane is parabolic.
11. The prosthetic disc of claim 9 wherein the curve of the articulating surface in a first disc body plane is hyperbolic.
12. The prosthetic disc of claim 9 wherein the curve of the articulating surface in a first disc body plane follows a radius.
13. The prosthetic disc of claim 12 further comprising a base plate secured to the disc body base surface.
14. The prosthetic disc of claim 13 wherein the base plate comprises an anchor.
15. A method of installing a prosthetic disc comprising the steps of:
removing a portion of an intervertebral disc, thereby creating an intervertebral disc space, and
placing a prosthetic disc substantially within said intervertebral disc space;
wherein the prosthetic disc comprises:
a disc body, having a disc body base surface having a center point having a base surface central normal vector extending therefrom; and
a disc body articulating surface opposite the disc body base plate surface, the articulating surface being concave along a first disc body plane parallel to the base plate central normal vector, and being convex along a second disc body plane, parallel to the base plate central normal vector and orthogonal to the first disc body plane.
16. A prosthetic disc comprising:
A first disc body, having a first disc body base surface having a first vector extending normally therefrom, and a first disc body articulating surface opposite the first disc body base surface, the articulating surface being concave along a first disc body first plane parallel to the first vector, and being convex along a first disc body second plane, parallel to the first vector and orthogonal to the first disc body first plane, the outer regions of the first disc body articulating surface along and adjacent to the first disc body first plane defining a first disc body concave region and the outer regions of the first disc body articulating surface along and adjacent to the first disc body second plane defining a first disc body convex region;
a second disc body, having a second disc body base surface having a second vector extending normally therefrom, and a second disc body articulating surface opposite the second disc body base surface, the articulating surface being concave along a second disc body first plane parallel to the second vector, and being convex along a second disc body second plane, parallel to the second vector and orthogonal to the second disc body first plane, the outer regions of the second disc body articulating surface along and adjacent to the second disc body first plane defining a second disc body concave region and the outer regions of the second disc body articulating surface along and adjacent to the second disc body second plane defining a second disc body convex region;
the first disc body articulating surface and the second disc body articulating surface being disposed in abutting relationship, and oriented such that at least a portion of the first disc body concave region is mated to at least a portion of the second disc body convex region or at least a portion of the first disc body convex region is mated to at least a portion of the second disc body concave region.
17. An artificial disc suitable for placement between adjacent vertebra comprising:
a first disc body, having a first disc body base surface and a first disc body articulating surface opposite said first disc body surface, wherein at least a substantial region of said first disc body articulating surface is a hyperbolic paraboloid; and
a second disc body, having a second disc body base surface and a second disc body articulating surface opposite said second disc body surface, wherein at least a substantial region of said second disc body articulating surface is a hyperbolic paraboloid, and wherein said second disc body articulating surface is substantially reciprocal to first disc body articulating surface, wherein said first disc body articulating surface and said second disc body articulating surface being disposed in abutting relationship and cooperatively form a saddle-joint.
18. An artificial disc suitable for placement between adjacent vertebra comprising:
an upper body having an upper body base surface and an upper body concave-convex articulating surface opposite said first disc body base surface; and
a lower body, having a lower body base surface and a lower body concave-convex articulating surface opposite said lower body base surface;
the upper body and lower body forming a saddle joint by the reciprocal reception of the lower body concave-convex articulating surface with the upper body concave-convex articulating surface.
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