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WO2008062397A1 - Dispositif d'espacement vertébral articulaire - Google Patents

Dispositif d'espacement vertébral articulaire Download PDF

Info

Publication number
WO2008062397A1
WO2008062397A1 PCT/IL2007/001288 IL2007001288W WO2008062397A1 WO 2008062397 A1 WO2008062397 A1 WO 2008062397A1 IL 2007001288 W IL2007001288 W IL 2007001288W WO 2008062397 A1 WO2008062397 A1 WO 2008062397A1
Authority
WO
WIPO (PCT)
Prior art keywords
spinal
pivot
vertebrae
extension
pivoting
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.)
Ceased
Application number
PCT/IL2007/001288
Other languages
English (en)
Inventor
Boris Silberstein
Alex Feldman
Anatoly Konik
Eduard Batkilin
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
FLEXSIS SURGICAL Ltd
Original Assignee
FLEXSIS SURGICAL Ltd
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 FLEXSIS SURGICAL Ltd filed Critical FLEXSIS SURGICAL Ltd
Publication of WO2008062397A1 publication Critical patent/WO2008062397A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442—Intervertebral or spinal discs, e.g. resilient
    • A61F2/4425—Intervertebral or spinal discs, e.g. resilient made of articulated components
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools for implanting artificial joints
    • A61F2/4603—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4611—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30224—Three-dimensional shapes cylindrical
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    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The 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
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30331—Connections 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
    • A61F2002/30362—Connections 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
    • A61F2002/30369—Limited lateral translation of the protrusion within a larger recess
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    • A61F2/00—Filters 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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    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The 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
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30601—Special structural features of bone or joint prostheses not otherwise provided for telescopic
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters 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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    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The 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
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30604—Special structural features of bone or joint prostheses not otherwise provided for modular
    • A61F2002/30616—Sets comprising a plurality of prosthetic parts of different sizes or orientations
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30621—Features concerning the anatomical functioning or articulation of the prosthetic joint
    • A61F2002/30649—Ball-and-socket joints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30795—Blind bores, e.g. of circular cross-section
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/3085—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/30932—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for retarding or preventing ingrowth of bone tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2002/448—Joints for the spine, e.g. vertebrae, spinal discs comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools for implanting artificial joints
    • A61F2/4603—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2002/4622—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof having the shape of a forceps or a clamp
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools for implanting artificial joints
    • A61F2/4603—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2002/4625—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use
    • A61F2002/4627—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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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    • A61F2/4603—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2002/4625—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use
    • A61F2002/4628—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use with linear motion along or rotating motion about an axis transverse to the instrument axis or to the implantation direction, e.g. clamping
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    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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Definitions

  • the present invention relates to spinal support devices configured to restore and/or maintain intervertebral disk space and preserve partial motion between the vertebrae.
  • Intervertebral discs facilitate motion between adjacent spinal vertebrae so that the spine has overall mobility. Motions between adjacent spinal vertebrae include, inter alia, flexion, extension, lateral bending, and axial rotation. Additionally, intervertebral discs serve as spacers between adjacent vertebrae, allowing spinal nerve roots to freely exit without vertebral impingement.
  • Impingement of spinal nerve roots may be accompanied by disabling pain, and/or paralysis of upper and/or lower limbs.
  • One common method of relieving spinal nerve impingement uses an artificial spinal disc replacement that installs between two adjacent vertebrae and restores the height of the intervertebral space.
  • many artificial disc replacements are designed to restore the above-noted motions of flexion, extension, lateral bending, and axial rotation of the implanted intervertebral vertebral space.
  • a method for installing a spinal spacer comprising placing a human in a prone position, reducing a lordotic angle between two adjacent vertebrae, incising an incision in epidermal tissue adjacent to a posterior portion of the spine of the human, boring two bores through the incision between two spinal vertebrae, and placing a pivot within each of the two bores.
  • pivoting motion between the two spinal vertebrae is limited to flexion and extension.
  • the method includes restoring the lordotic angle between the two spinal vertebrae.
  • the at least one of the pivots is configured to duplicate at least one parameter associated with the two spinal vertebrae, the at least one parameter comprising at least one of a maximum intervertebral flexion angle, and a maximum intervertebral extension angle.
  • a method for installing a spinal spacer comprising incising an incision in epidermal tissue adjacent to a posterior portion of a spine of a human, boring a first bore through the incision between two spinal vertebrae, a spinal process, and a first spinal facet, placing a first pivot within the first bore, boring a second bore between the two spinal vertebrae, the spinal process, and a second spinal facet, placing a second pivot within the second bore, and pivoting the two spinal vertebrae on the pivot.
  • the method includes pivoting the first pivot in at least one of flexion and extension, lateral bending, and axial rotation.
  • the pivoting occurs around a virtual center of rotation.
  • the method includes limiting the pivoting motion between the two spinal vertebrae to flexion and extension.
  • at least one of the first pivot and the second pivot is configured to duplicate at least one parameter associated with the two spinal vertebrae, the at least one parameter comprising at least one of a maximum intervertebral flexion angle, and a maximum intervertebral extension angle.
  • a method for installing a spinal spacer comprising incising an incision in epidermal tissue adjacent to a posterior portion of a spine of a human, boring two bores through the incision between two spinal vertebrae, placing a pivot assembly within each of the bores, limiting a pivot motion provided by the pivots to flexion and extension, and pivoting the two spinal vertebrae in flexion and extension.
  • the human is placed in the prone position in a manner that reduces an intervertebral angle between adjacent surfaces of the two spinal vertebrae.
  • the pivoting occurs around a static center of rotation.
  • an intraarticular spinal spacing device having a longitudinal axis, the device comprising an upper elongate element having a lower surface, a lower elongate element having an upper surface, and a pivot joint operatively associated with the upper surface and the lower surface, the pivot joint offsetting the upper surface from the lower surface at least in the vicinity of the pivot joint.
  • pivot movement around the pivot joint is limited by contact between the lower surface and the upper surface at adjacent longitudinal ends.
  • the pivot joint is located eccentric along the longitudinal axis.
  • the device during pivoting motion, the maximum offset between the upper and lower surfaces on a first side of the pivot is greater than the maximum offset between the upper and lower surfaces on a second side of the pivot.
  • the device includes an outer surface having at least one stabilizing extension extending outwardly therefrom.
  • the device includes an outer surface comprising a round cylinder.
  • the outer surface includes at least one screw thread extending outwardly therefrom.
  • an intraarticular spinal spacing system comprising two elongate pivoting elements, a first elongate pivoting element having a first longitudinal axis and a first average cross-sectional diameter, and a second elongate pivoting element having a second longitudinal axis and a second average cross-sectional diameter, wherein the sum of the first and second average cross-sectional diameters is less than a transverse distance across a human intervertebral space.
  • At least one of the two elongate pivoting elements includes an upper member, a lower member, and a pivot joint operatively associated with the upper member and the lower member.
  • the upper member includes a lower surface
  • the lower member includes an upper surface
  • the upper surface is offset from the lower surface at least in the vicinity of the pivot joint.
  • the pivot joint comprises a pivot axis that is transverse to the longitudinal axis of the at least one elongate pivoting element.
  • the pivot joint includes a spherical extension and the pivot joint moves in at least one of flexion and extension, lateral bending, and axial rotation.
  • the spacing system includes an axis passing through said pivot joint of said first elongate pivoting element and said pivot joint of said second elongate pivoting element; said axis being transverse to the longitudinal axis of said at least one elongate pivoting element.
  • At least one of the two elongate pivoting elements includes an outer surface having at least one stabilizing extension extending outwardly therefrom. In embodiments, at least one of the two elongate pivoting elements includes an outer surface comprising a round cylinder.
  • the outer surface includes at least one screw thread extending radially outwardly therefrom.
  • Figure IA shows a spinal spacer, according to embodiments of the invention
  • Figure IB shows a cross-sectional view of a pivot joint of the spinal spacer of Figure IA, according to embodiments of the invention
  • Figure 1C shows dual spinal spacers of Figure IA installed between two vertebrae, shown in a posterior-lateral view, according to embodiments of the invention
  • Figure 2 A shows a side view of the spinal spacer of Figure IA, according to embodiments of the invention
  • Figures 2B-2D show side views of vertebrae, according to embodiments of the invention
  • Figure 3 shows the spinal spacer of Figure 2 A installed between two vertebrae, shown in a side cross-section, according to embodiments of the invention
  • Figure 4 shows an installation tool for installing the spinal spacer of Figure 3, according to embodiments of the invention
  • FIGs 5-7 show the installation tool shown in Figure 4 coupling with the spinal spacer of Figure 3, according to embodiments of the invention
  • FIGs 8-14 show details for surgically installing the spinal spacer of Figure 3, according to embodiments of the invention.
  • FIGS 15-16 show alternative configurations of the spinal spacer of Figure 3, according to embodiments of the invention.
  • Embodiments of the present invention are to an intervertebral disk spacer, the principles of which may be better understood with reference to the drawings and accompanying descriptions.
  • Figure IA shows a spinal spacer 100 comprising an upper elongate element 20 and a lower elongate element 30.
  • Upper elongate element 20 articulates with lower elongate element 30 with a pivot joint 40; alternatively referred to herein as pivot element 40, or pivot 40.
  • an external portion of pivot joint 40 comprises a semicircular extension 41 that extends from lower elongate element 30 and moves within a semicircular depression 43 associated with upper elongate element 40.
  • Internal pivot interface 82 is configured so that a space 84 is formed between semi-circular depression 43 and semi-circular extension 41 when upper elongate element 20 and lower elongate element 30 are parallel. Space 84 allows the pivoting motion associated with pivot joint 40 with respect to transverse axis 47 and along pivot interface 82.
  • transverse axis 47 refers to any axis passing transversely through a center of rotation 103 of pivot joint 40, including axes that are skewed with respect to a horizontal axis represented by transverse axis 47, including, for example, a first skewed transverse axis 47 1 and a second skewed transverse axis 47". Additionally, in embodiments, longitudinal axis 49 passes through center of rotation 103. In some embodiments, the spherical shape of internal pivot interface 82 allows longitudinal skewing of upper elongate element 20 with respect to lower elongate element 30.
  • longitudinal axis 49 of upper elongate element may assume a first longitudinal skewed axis 49' or a second longitudinal skewed axis 49" with respect to longitudinal axis 49 of lower elongate element 30, also seen in Figure IA.
  • pivot joint 40 There are many alternative configurations and designs for pivot joint 40, some of which will be discussed below.
  • Figure 1C shows dual spinal spacers 100 installed between an upper vertebra 70 and a lower vertebra 80, with left spinal spacer 100 between a spinous process 199 and a left facet 117 and right spinal spacer 100 between spinous process 199 and a right facet 119.
  • Dual spinal spacers 100 provide a pivot axis 47 that is transverse to longitudinal axis 49 passing through either one of spinal spacers 100. Dual pivot joints 40 preserve flexion and extension motions 51 while substantially preventing lateral bending 53, and axial rotation 59 motions between spinal vertebrae 70 and 80. Possible advantages to limiting some motions of vertebrae
  • Spinal spacer 100 is configured to easily install into vertebrae 70 and 80.
  • first spinal spacer 100 is between spinous process 199 and right facet 119 andsecond spinal spacer 100 is between spinous process 199 and left facet 117, the opposite could occur, with first spinal spacer 100 between spinous process 199 and left facet 117 and second spinal spacer 100 between spinous process 199 and right facet 119.
  • spinal spacers 100 Positional stability of implanted spinal spacers 100 may be ensured through any number of design configurations.
  • spinal spacers may be ensured through any number of design configurations.
  • spinal spacers may be ensured through any number of design configurations.
  • spinal spacers may be ensured through any number of design configurations.
  • spinal spacers may be ensured through any number of design configurations.
  • spinal spacers may be ensured through any number of design configurations.
  • spinal spacer 100 include one or more recesses 110 that permit bone ingrowth to promote stabilization of spinal spacer 100.
  • cylindrically shaped spinal spacer In embodiments, cylindrically shaped spinal spacer
  • recesses 110 and/or threads 90 include osteogenic- promoting materials that promote bony ingrowth from vertebrae 70 and 80.
  • elongate elements 20 and 30 and pivot joint 40 are optionally treated with materials which prevent bone ingrowth.
  • Spinal spacer 100 can be manufactured from any combination of biologically compatible material of suitable strength and durability, for example, stainless steel, chrome cobalt alloys, plastics and/or composite materials.
  • Spinal spacer 100 is optionally manufactured in multiple configurations to fit a variety of shapes and sizes of vertebrae 70 and 80.
  • spinal spacer 100 is optionally manufactured in a variety of longitudinal lengths 107 to fit vertebrae 70 and 80 having different anterior-posterior lengths.
  • spinal spacer 100 may be manufactured in a variety of diameters 109 to fit larger or smaller intervertebral spaces 97 ( Figure 1C).
  • each spinal spacer 100 is optionally manufactured in a variety of flexion ranges of motion 161 and extension ranges of motion 160 to fit the implanted individual with a specific range of flexion and extension 51 (Figure 1C) that duplicates ranges of motion of the natural vertebrae 70 and 80.
  • Figures 2B-2D to determine the appropriate ranges of motion for a given spinal spacer 100, the following measurements are taken with the individual standing without any weight load:
  • a neutral intervertebral angle 169 that is measured between vertebrae 70 and 80 along the adjacent vertebral plates, alternatively referred to herein as vertebral surfaces
  • f max - a maximum flexion angle 172 that is measured along the adjacent vertebral plates with vertebrae 70 and 80 maximally flexed in a direction 171
  • e max - a maximum extension angle 132 that is measured along the adjacent vertebral plates with vertebrae 70 and 80 maximally extended in a direction 131.
  • Table 1 shows values for an exemplary adult male patient 98 (Figure 8) who presents for implantation of spinal spacer 100 following an industrial injury that has caused intervertebral space between lumbar 4 (L4) and lumbar 5 (L5) to partially collapse, resulting in intractable nerve pain.
  • L4/L5 our exemplary adult male patient 98 is healthy with appropriate spinal range of motion.
  • Patient 98 presents with following angular measurements with respect to L4/L5 in the table above .
  • ⁇ o - neutral intervertebral angle 169 is 6 degrees;
  • fmax - maximum flexion angle 172 is 13 degrees;
  • ⁇ ma x - maximum extension angle 132 is 2 degrees.
  • Extension range of motion 160 is equal to or greater than maximum extension angle 132, plus the neutral intervertebral angle 169:
  • extension range of motion 160 > e max + ⁇ o ] therefore, extension range of motion 160 will be equal to or greater than 8 degrees.
  • Flexion range of motion 161 is equal to or greater than maximum flexion angle 172, minus neutral intervertebral angle 169, and greater than or equal to zero:
  • flexion range of motion 161 will be equal to or greater than 7 degrees.
  • spinal spacer 100 can be configured to duplicate axial motion of vertebrae 70 and 80.
  • pivot joint 40 may be offset along longitudinal axis 49 so that an anterior portion 22 is longer than a posterior portion 21.
  • Figure 4 shows an installation tool 24, comprising a handle 31, a tube 33 and a forward receptacle 139.
  • forward receptacle 139 includes arms 26 that are designed to grasp tool receptacles 111 on spinal spacer 100.
  • forward receptacle 139 includes a stabilizer rod 28 that is placed between upper elongate element 20 and lower elongate element 30.
  • arms 26 press radially inward to engage tool receptacles
  • Spinal spacer 100 is implanted using a posterior or posterior-lateral incision through the epidermal tissue and a bore extending anteriorly from the posterior of intervertebral space 97. Proper positioning of the patient before implantation can aid in proper placement of spinal spacer 100.
  • spine 182 on standing person 98 demonstrates curvatures associated with cervical 123, thoracic 125, lumbar 127 and sacral 129 sections.
  • Each lordotic intervertebral angle 169 is angled lordotically so that lumbar vertebrae 70 and 80 have a greater distance between the anterior aspect of adjacent vertebrae 70 and 80 than the posterior aspect of adjacent vertebrae 70 and 80.
  • lordosis 121 The sum of all lordotic intervertebral angles 197 of lumbar section 127 create a lordosis 121.
  • Lordotic intervertebral angle 169 can make it difficult if not almost impossible to implant spinal spacer 100.
  • patient 98 is placed with the upper torso in a prone position on a surgical table 95, while hips and knees are in a kneeling position (not shown); causing vertebral plates adjacent to intervertebral space 97 to become substantially parallel.
  • Parallel plates on vertebrae 70 and 80 facilitate drilling and tapping.
  • placing the spine in the prone position in a manner that increases surgeon access to intervertebral space 97 allows the surgeon to decompress nerve roots 163; remove stenosed bone on vertebrae 70 and 80; and remove any debris within intervertebral space 97, including cartilage and bone fragments.
  • a drill bit 32 is bored through a portion of intervertebral space 97, optionally creating a bore having a central axis that is parallel to the adjacent plates of vertebrae 70 and 80.
  • spinal spacers 100 having alternative cross-sectional configurations, for example, a rectangular shape
  • bone cutting instruments that can be used to fashion a rectangular bore between vertebrae 70 and 80.
  • a thread tap 35 is rotated in clockwise direction 149 through the bore in intervertebral space 97.
  • screw threads 90 comprising self-tapping threads that cut into spinal vertebrae 70 and 80 during rotation 149, so that spinal spacer 100 forms taps 93.
  • intervertebral space 97 The tapped bore in intervertebral space 97 is now ready to receive spinal spacer 100.
  • spinal spacer 100 previously loaded on installation tool 24, is rotated in direction 149 to pass in an anterior direction through the posterior aspect of intervertebral space 97.
  • Installation tool 24 maintains upper elongate element 20 substantially parallel to lower elongate element 30.
  • Figure 13 demonstrates spinal spacer 100 fully installed, while Figure 14 demonstrates that spinal spacer 100 now functions with lordotic intervertebral angle 197 substantially duplicating the natural tilt between vertebrae 70 and 80.
  • spinal spacer 100 has been described during installation between intervertebral spaces of lumbar section 127, it should be understood that the design of the present invention can be easily modified for installation in thoracic 125, cervical 123 sections and/or between lumber 127 and sacral 129 sections.
  • pivot joint 40 can possibly provide advantages in installation, positioning, long-term stability and/or pain relief using spinal spacer 100.
  • center of rotation 103 through which transverse axis 47 passes remains substantially static during pivoting of vertebrae 70 and 80 and is referred to herein as a static center of rotation 103.
  • other configurations of pivot 40 allow some additional movement between vertebrae 70 and 80.
  • Figure 15 shows an optional embodiment of pivot joint 40 wherein upper depression 43 is elongate, thereby forming a shifting center of rotation 101 that shifts along longitudinal axis 49 during pivoting of vertebrae 70 and 80.
  • Upper depression 43 may be configured in this elongate fashion and/or in a variety of alternative configurations in order to duplicate natural anatomic movement between spinal vertebrae 70 and 80; the term "natural anatomic movement” referring to movement between vertebrae 70 and 80 in the natural human state, without pathology and/or spinal spacer 100.
  • spinal spacer can be configured to facilitate manipulation of vertebrae 70 and 80 after installing a first spinal spacer.
  • spinal spacers 100 include ball and socket joints 151.
  • first spinal spacer 100 After first spinal spacer 100 is installed, the surgeon has the option to manipulate spinal vertebra 70 with respect to spinal vertebra 80 (not shown) in motions of bending 53, and axial rotation 59 around ball and socket joint 151; motions which aid the surgeon in manipulating vertebrae 70 and 80 to facilitate installation of second spinal spacer 100.
  • spinal spacer is intended to include all such new technologies a priori.
  • composition or method may include additional ingredients and/or steps, but only if the additional ingredients and/or steps do not materially alter the basic and novel characteristics of the claimed composition or method.
  • a compound or “at least one compound” may include a plurality of compounds, including mixtures thereof.
  • range format is merely for convenience and brevity, and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.
  • a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range.
  • the phrases "ranging/ranges between” a first indicate number and a second indicate number and “ranging/ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.
  • the term "method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.
  • treating includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.
  • the inventors have found that in certain cases, restoration of spinal flexion and extension while stabilizing the spine against lateral and rotatory motion, presents some advantages over artificial intervertebral spacers that additionally restore lateral bending, and axial rotation, of the spine.
  • Such advantages include maintenance of pain reduction. While the exact mechanism by which the present invention provides pain reduction is not known, it is presumed that the motions of spinal lateral bending and axial rotation can cause temporary narrowing of the intervertebral space that irritates exiting spinal root.
  • intervertebral spacer and/or intervertebral disk include support of all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.
  • All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference.
  • citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Transplantation (AREA)
  • Neurology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un dispositif d'espacement vertébral intra-articulaire (100) présentant un axe longitudinal. Ledit dispositif est constitué des éléments suivants : i) un élément supérieur allongé (20) doté d'une surface inférieure; ii) un élément inférieur allongé (30) doté d'une surface supérieure; et iii) une articulation à pivot (40) associée de manière opérationnelle à ladite surface supérieure et à ladite surface inférieure, ladite articulation à pivot décalant ladite surface supérieure de ladite surface inférieure au moins dans le voisinage de ladite articulation à pivot. La présente invention concerne également un procédé permettant d'installer un dispositif d'espacement vertébral. Ledit procédé est constitué des étapes suivantes : placer un patient en position couchée sur le ventre; réduire l'angle lordotique entre deux vertèbres adjacentes; pratiquer une incision dans le tissu épidermique adjacent à une partie postérieure de la colonne vertébrale dudit patient; pratiquer deux trous à travers l'incision entre deux vertèbres; et disposer un pivot dans chacun des deux trous.
PCT/IL2007/001288 2006-11-24 2007-10-25 Dispositif d'espacement vertébral articulaire Ceased WO2008062397A1 (fr)

Applications Claiming Priority (2)

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US60/860,707 2006-11-24

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2948869A1 (fr) * 2009-08-07 2011-02-11 Hassan Razian Prothese discale perfectionnee apte a etre interposee entre deux vertebres

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000013620A1 (fr) * 1998-09-04 2000-03-16 Spinal Dynamics Corporation Prothese discale, cylindrique, hemispherique, a filetages paralleles
US20040049280A1 (en) * 1998-04-23 2004-03-11 Cauthen Joseph C. Articulating spinal implant
US20050143820A1 (en) * 2003-12-02 2005-06-30 St. Francis Medical Technologies, Inc. Method of laterally inserting an artificial vertebral disk replacement implant with translating pivot point
US20060089717A1 (en) * 2004-10-15 2006-04-27 Manoj Krishna Spinal prosthesis and facet joint prosthesis

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040049280A1 (en) * 1998-04-23 2004-03-11 Cauthen Joseph C. Articulating spinal implant
WO2000013620A1 (fr) * 1998-09-04 2000-03-16 Spinal Dynamics Corporation Prothese discale, cylindrique, hemispherique, a filetages paralleles
US20050143820A1 (en) * 2003-12-02 2005-06-30 St. Francis Medical Technologies, Inc. Method of laterally inserting an artificial vertebral disk replacement implant with translating pivot point
US20060089717A1 (en) * 2004-10-15 2006-04-27 Manoj Krishna Spinal prosthesis and facet joint prosthesis

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2948869A1 (fr) * 2009-08-07 2011-02-11 Hassan Razian Prothese discale perfectionnee apte a etre interposee entre deux vertebres

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