WO2013060168A1 - 融合假体 - Google Patents

融合假体 Download PDF

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Publication number
WO2013060168A1
WO2013060168A1 PCT/CN2012/078528 CN2012078528W WO2013060168A1 WO 2013060168 A1 WO2013060168 A1 WO 2013060168A1 CN 2012078528 W CN2012078528 W CN 2012078528W WO 2013060168 A1 WO2013060168 A1 WO 2013060168A1
Authority
WO
WIPO (PCT)
Prior art keywords
fusion
prosthesis
bone
atlas
fusion prosthesis
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/CN2012/078528
Other languages
English (en)
French (fr)
Inventor
刘忠军
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.)
Beijing AK Medical Co Ltd
Original Assignee
Beijing AK Medical Co 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 Beijing AK Medical Co Ltd filed Critical Beijing AK Medical Co Ltd
Priority to EP12844108.6A priority Critical patent/EP2772230B1/en
Publication of WO2013060168A1 publication Critical patent/WO2013060168A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A61F2/4465—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
    • 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
    • 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
    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • 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
    • A61F2/3094—Designing or manufacturing processes
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30011—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in porosity
    • 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
    • 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
    • A61F2002/30476—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
    • A61F2002/30507—Connections 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30576—Special structural features of bone or joint prostheses not otherwise provided for with extending fixation tabs
    • A61F2002/30578—Special structural features of bone or joint prostheses not otherwise provided for with extending fixation tabs having apertures, e.g. for receiving fixation screws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
    • 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
    • A61F2002/30772—Apertures or holes, e.g. of circular cross section
    • A61F2002/30784—Plurality of holes
    • A61F2002/30787—Plurality of holes inclined obliquely with respect to each other
    • 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
    • A61F2002/30772—Apertures or holes, e.g. of circular cross section
    • A61F2002/30784—Plurality of holes
    • A61F2002/30789—Plurality of holes perpendicular with respect to each other
    • 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
    • A61F2002/30838—Microstructures
    • 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
    • A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • 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
    • A61F2002/3092—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
    • A—HUMAN NECESSITIES
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    • 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
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    • A61F2002/30948—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using computerized tomography, i.e. CT scans
    • 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
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30962—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using stereolithography
    • 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
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    • A61F2002/30968—Sintering
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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
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    • A61F2002/3097—Designing or manufacturing processes using laser
    • 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
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2002/4495—Joints for the spine, e.g. vertebrae, spinal discs having a fabric structure, e.g. made from wires or fibres
    • A—HUMAN NECESSITIES
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    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A—HUMAN NECESSITIES
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    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
    • A61F2310/00796—Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04C—ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS
    • F04C2270/00—Control; Monitoring or safety arrangements
    • F04C2270/04—Force
    • F04C2270/041—Controlled or regulated

Definitions

  • the present invention relates to the field of orthopedic implants, and more particularly to a fusion prosthesis.
  • the spine is the central axis of the human body, with the upper part connected to the occipital bone at the bottom of the skull and the lower part reaching the end of the tailbone.
  • the spine is connected by the vertebrae, humerus and coccyx by intervertebral discs, intervertebral joints and many ligaments. It is the active center of the trunk and the hub of mechanical transmission. It supports the weight, shock absorption, protects the central nervous system, and provides the extension of the upper part of the body. Flexion, lateral bending, torsion and other motor functions.
  • the problem in the prior art is that continuous pressure is required between the artificial vertebral body and the physiological vertebral body of the upper and lower adjacent segments to maintain close contact to prevent displacement and slippage between the implant and the adjacent vertebral body, and therefore must be implanted separately.
  • a rigid nail plate or nail rod system that maintains pressure, and this type of fixation system is usually higher than the original physiological vertebral surface and adversely affects peripheral nerves, blood and soft tissue;
  • the difference in elastic modulus of physiological bone is too large to be integrated into one body, so fatigue fracture is likely to occur in the long term. It is particularly important to point out that certain specific stages of vertebral joints such as atlantoaxial joints are very special and important spinal structures that connect the skull to the spine.
  • a fusion prosthesis according to the present invention is disposed between the first bone structure and the second bone structure to replace the bone structure between the first bone structure and the second bone structure, the fusion prosthesis including the prosthesis body and the prosthesis Prosthesis fusion on the subject
  • the prosthetic fusion surface is in contact with at least one of the first bone structure and the second bone structure, and the surface of the prosthetic fusion surface has a microporous structure.
  • the microporous structure is a multidirectional microporous structure comprising a plurality of interconnected micropores. Further, the pores of the microporous structure have a pore diameter of from ⁇ to 1800 ⁇ .
  • the fusion prosthesis is a pivot fusion prosthesis for replacing the atlas between the atlas and the third cervical vertebra
  • the prosthetic fusion surface comprises an upper joint fusion disposed at the upper end of the prosthesis body and conforming to the atlas surface.
  • the frontal surface of the fusion fusion prosthesis is located within the physiological surface directly in front of the original pivotal axis after being implanted into the human body.
  • the prosthesis body is provided with a plurality of third connecting holes which are inclined and extend upward, and the pivot fusion prosthesis is respectively connected to the atlas and the third cervical vertebra through the fixing members.
  • the upper joint fusion surface of the prosthesis body is provided with a dentate boss at a position corresponding to the odontoid of the original pivot.
  • the upper end of the prosthesis body is provided with a vertical panel corresponding to the lateral block outside the anterior arch of the atlas of the atlas, and the vertical panel and the odontoid protrusion together form a clamping of the anterior arch of the atlas.
  • the vertical panels are two and respectively correspond to the left and right side blocks on the outer side of the anterior arch of the atlas, and the first connecting holes are respectively disposed on the vertical panel.
  • the prosthetic fusion surface further includes a lower joint fusion surface disposed at a lower end of the prosthesis body and conforming to the third cervical vertebra. Further, one or more second connecting holes are disposed on the lower joint fusion surface. Further, a reinforcing portion is provided on the surface and/or the inside of the prosthesis body. Further, the fusion prosthesis is disposed between the atlas and the third cervical vertebra to replace the pivotal vertebra. After the fusion prosthesis is implanted into the human body, the overall occupational height is consistent with the original physiological axis joint or extended downward to replace the pivotal joint. The third cervical vertebra may replace more cervical vertebral segments. Further, the prosthesis body is a microporous structure.
  • the prosthesis body is an equal-sized metal implant prepared according to a patient's CT/MRI/UCT tomographic data, and the fusion prosthesis is provided with a prosthetic fusion surface, a prosthetic fusion surface.
  • the surface of the prosthetic fusion surface is a microporous structure for facilitating the growth of bone cells, and the microporous structure is a mutual a connected multi-directional micropore structure that facilitates bone cell creeping, and the prosthetic fusion surface of the post-fusion prosthesis will have bone with the atelectal surface of at least one of the first bone structure and the second bone structure Fusion to achieve long-term stability.
  • Figure 1 is a schematic perspective view of a fusion prosthesis according to the present invention
  • Figure 2 is a schematic view of a micropore structure of a fusion prosthesis according to the present invention
  • Figure 3 is a fusion prosthesis and a vertebral body according to the present invention.
  • Figure 4 is a schematic view showing the structure of a fusion prosthesis and a pivotal joint according to the present invention
  • Figure 5 is a schematic exploded view of a fusion prosthesis and a screw according to the present invention; Schematic diagram of the bone graft hole of the fusion prosthesis
  • FIG. 7 is a schematic structural view of the extension and extension embodiment of the fusion prosthesis according to the present invention.
  • FIG. 8 is an application state of the extension and extension embodiment of the fusion prosthesis according to the present invention. Schematic diagram of the structure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
  • Fig. 8 The fusion prosthesis 1 according to the present invention as shown in Fig.
  • the prosthesis 1 is disposed between the first bone structure 2 and the second bone structure 3 to replace the bone structure between the first bone structure 2 and the second bone structure 3, fusion
  • the prosthesis 1 includes a prosthesis body 10 and a prosthetic fusion surface disposed on the prosthesis body 10, the prosthetic fusion surface being conformed to at least one of the first bone structure 2 and the second bone structure 3, the prosthesis fusion
  • the surface of the surface is a microporous structure, and the microporous structure is a plurality of multi-directional microporous structures that are connected to each other.
  • the prosthesis main body 10 is an equal-sized medical metal implant made based on CT/MRI/UCT tomographic data of the patient, and the fusion prosthesis 1 is made of medical metal, so that it has Good biocompatibility.
  • the fusion prosthesis 1 is provided with a prosthetic fusion surface, and the prosthetic fusion surface is constructed according to the replaced bone structure and is in good agreement with at least one of the first bone structure 2 and the second bone structure 3, the prosthetic fusion surface
  • the pores of the microporous structure 30 have a diameter of from ⁇ to 1800 ⁇ . As shown in FIG.
  • the microporous structure 30 is a multi-directional microporous structure that communicates with each other, and the pores are favorable for bone cell creeping.
  • the prosthetic fusion surface of the fusion prosthesis 1 will be combined with the first bone structure. Bone fusion occurs at the osteoarticular surface of at least one of the second bone structure 3 to achieve long-term stability.
  • both ends of the fusion prosthesis 1 have prosthetic fusion faces respectively conforming to the first bone structure 2 and the second bone structure 3.
  • the prosthesis body 10 is made of a medical metal, and the surface and the internal pores of the microporous structure are mutually penetrated, and the pore diameter of the microporous structure is 1800 ⁇ to 1800 ⁇ m. As shown in Fig.
  • the fusion prosthesis 1 is a pivot fusion prosthesis disposed between the first bone structure 2 and the second bone structure 3 to replace the pivotal vertebra.
  • the first bone structure 2 is a atlas and the second bone structure 3 is a third cervical vertebra.
  • the prosthetic fusion surface includes an upper joint fusion surface 20 disposed at the upper end of the prosthesis body 10 and conforming to the atlas.
  • the prosthetic fusion surface further includes a lower joint fusion surface 60 disposed at a lower end of the prosthesis body 10 and conforming to the third cervical vertebra.
  • the vertebral fusion prosthesis does not retain the transverse process, spinous process, and vertebral arch structure.
  • the axial fusion prosthesis is in size with the patient's original vertebral vertebral body.
  • the body remains basically the same.
  • the upper and lower ends of the atlantoaxial fusion prosthesis are respectively provided with an upper joint fusion surface 20 and a lower joint fusion surface 60, and the upper joint fusion surface 20 and the lower joint fusion surface 60 respectively extract the inferior tibiofibular joint surface and the third cervical vertebrae upper joint surface.
  • the surface data is processed by a CNC machine tool. It is also possible to construct a surface with a curved surface fitting feature by rapid prototyping techniques such as laser sintering or high-energy electron beam melting.
  • the upper joint fusion surface 20 of the axial fusion prosthesis is based on the subarachnoid articular surface data. It is constructed and well matched with the inferior articular surface of the atlas.
  • the lower joint fusion surface 60 of the axial fusion prosthesis is constructed according to the third cervical vertebrae articular surface data and is in good agreement with the third cervical vertebrae articular surface. Since the surfaces of the upper joint fusion surface 20 and the lower joint fusion surface 60 are both microporous structures, the upper joint fusion surface 20 and the lower joint fusion surface 60 of the post-operative vertebral fusion prosthesis will be respectively associated with the atlas and third cervical vertebrae. Bone fusion occurs on the articular surface to achieve long-term stability. As shown in FIG.
  • the odontoid boss 40 is disposed on the upper joint fusion surface 20 of the prosthesis body 10 corresponding to the odontoid position of the original pivotal vertebra.
  • the upper end of the prosthesis body 10 is provided with a vertical panel 50 corresponding to the lateral block outside the anterior arch of the atlas of the atlas, for forming a pair of anterior arches with the odontoid boss 40.
  • the vertical panel 50 has two left and right side blocks respectively corresponding to the outer side of the anterior arch of the atlas, and the first connecting hole 51 is respectively disposed on the vertical panel 50.
  • the outer surface of the odontoid 40 and the inner surface of the vertical panel 50 in contact with the atlas side block are microporous structures 30 for facilitating the growth of bone cells, and the microporous structure 30 is a multi-directional microporous structure that communicates with each other.
  • the pore diameter is ⁇ to 1800 ⁇ , and the pore is favorable for bone cell creeping.
  • the connecting member 90 is screwed into the lateral side block of the atlas by two first connecting holes 51 to achieve initial stabilization, and the stable reconstruction of the cervical vertebra can be achieved after the bone fusion is completed.
  • the connecting member 90 is a fixing screw.
  • the frontal surface of the pivot fusion prosthesis is located within the physiological surface directly in front of the original pivotal axis after implantation in the human body.
  • the upper end of the vertebral fusion prosthesis is provided with a groove 11 at the lower edge of the anterior arch of the atlas and is well fitted with the lower edge of the anterior arch of the atlas.
  • the prosthesis body 10 is provided with a plurality of tilts and upwards.
  • the extended third connecting hole 62, the pivot fusion prosthesis is connected to the atlas and the third cervical vertebra through the fixing member 90, respectively.
  • the third connecting hole 62 is a screw hole
  • the fixing member 90 is a fixing screw.
  • the pivotal fusion prosthesis has a screw hole corresponding to the left and right lateral blocks of the lateral anterior arch of the atlas, and the fixation screw is screwed into the lateral vertebral block by two screw holes to achieve initial stabilization. .
  • the surface of the groove at the upper end of the prosthesis body 10 of the vertebral fusion prosthesis corresponding to the groove 11 at the lower edge of the anterior arch of the atlas is in contact with the lower edge of the atlas, which is a microporous structure, which is a mutual Connected multi-directional micro-porous structure, the pore diameter is ⁇ to 1800 ⁇ , the pore is favorable for bone cell creeping, and the upper end of the prosthesis body 10 of the post-operative vertebral fusion prosthesis corresponds to the groove at the lower edge of the anterior arch of the atlas
  • the micropore structure on the inner surface of the elbow will be bone-fused with the inferior anterior arch of the atlas to achieve long-term stability.
  • the anterior surface of the vertebral fusion prosthesis is located within the physiological surface directly in front of the original vertebral body after being implanted into the human body, that is, the anterior surface of the vertebral fusion prosthesis does not protrude from the original vertebral body after implantation.
  • the frontal physiological surface that is, the zero-notch that is said by the medical community, is advantageous in that the posterior vertebral body of the posterior atlas, the fusion fusion prosthesis, and the third cervical vertebrae will form a prominent
  • the nearly continuous anterior surface of the cervical vertebra does not have any adverse effect on the anatomical position of various soft tissues in front of the vertebral vertebral column, so as to avoid the conventional anterior cervical anterior plate fixation.
  • the surface causes foreign body sensation and discomfort when the patient breathes, swallows, and communicates with language.
  • one or more second connecting holes 61 are provided on the lower joint fusion surface 60.
  • the prosthetic fusion surface of the lower end of the prosthesis body 10 corresponding to the third cervical vertebrae articular surface is a microporous structure for facilitating the growth of bone cells, and the pore is beneficial to the growth and extension of the bone cells.
  • the prosthetic fusion surface corresponding to the upper surface of the third cervical vertebrae at the lower end of the vertebral fusion prosthesis will be bone-fused with the third cervical vertebrae joint surface to achieve long-term stability.
  • the prosthesis body 10 is provided with a plurality of bone graft holes 80, and the plurality of bone graft holes 80 are connected to each other or through a microporous structure.
  • the bone fusion prosthesis body is provided with a plurality of bone graft holes 80, which can accommodate autologous or allogeneic bone fragments and bone particles, and implant autologous or allogeneic bones in the bone graft holes 80 before or during surgery.
  • the block and bone particles can induce bone cell creeping and promote bone fusion.
  • the bone graft hole diameter is 2mm to 30mm, to facilitate the implantation of autologous or allogeneic bone fragments and bone particles of different diameters.
  • All or part of the surface and/or interior of the body of the aforementioned fusion prosthesis is coated with a hydroxyapatite coating formed by plasma spraying or electrochemical deposition and sintering.
  • the pivot fusion prosthesis is disposed between the atlas and the third cervical vertebra to replace the pivotal vertebra, and the total occupational height of the fusion prosthesis after implantation into the human body is consistent with the original physiological axis joint.
  • the surface and/or the interior of the prosthesis body 10 is provided with a reinforcing portion which is a reinforcing rib or a reinforcing plate to reinforce the structural strength of the prosthesis body 10.
  • the fusion prosthesis extends downward to lengthen to cover the third cervical vertebra 4 up to more cervical vertebrae.
  • the processing method of the axon fusion prosthesis is: obtaining the CT/MRI/UCT tomography data of the cervical vertebrae of the patient--establishing a three-dimensional data model of the cervical lesion in the computer--extracting the pivotal model and modifying the design to generate the fusion fusion prosthesis
  • A Using a CNC machine tool to process the forming according to the machining program converted from the shaft fusion prosthesis data generated in the computer, and then use the methods of electric discharge machining, chemical etching, mechanical drilling and cutting to process the bone graft required for drilling and milling. Holes, screw holes and micro holes, and fixing screws are made by conventional machining methods such as turning or milling;
  • B Melt molding by rapid prototyping techniques such as laser sintering or high-energy electron beam melting.
  • the specific methods are as follows: a) stratify the three-dimensional data model of the vertebral fusion prosthesis designed and built in the computer using professional software to obtain the contour data of a series of single-layer slices; b) input the above-mentioned series to the laser or high-energy electron beam rapid prototyping equipment Slice data
  • the fusion prosthesis of the present invention the surface of the prosthetic fusion surface is a microporous structure for facilitating the growth of bone cells, and the microporous structure is An interconnected multi-directional micro-porous structure, the pore is favorable for bone cell creeping, and the prosthetic fusion surface of the fusion prosthesis will be combined with at least one of the first bone structure and the second bone structure Bone fusion occurs on the surface to achieve long-term stability.

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  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Transplantation (AREA)
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  • Prostheses (AREA)

Abstract

一种融合假体（1），设置在第一骨结构（2）和第二骨结构（3）之间以替代第一骨结构（2）和第二骨结构（3）之间的骨结构，融合假体（1）包括假体主体（10）和设置在假体主体（10）上的假体融合面（20，60），假体融合面（20，60）与第一骨结构（2）和第二骨结构（3）之中的至少一个相贴合，假体融合面的表面为微孔结构（30）。假体主体（1）是根据患者的CT/MRI/UCT等断层扫描数据制作的等尺寸金属植入物，假体融合面（20，60）依据被替代的骨结构建造并与第一骨结构（2）以及第二骨结构（3）之中的至少一个良好吻合，假体融合面（20，60）表面的微孔结构（30）有利于骨细胞爬行长入，术后融合假体（1）的假体融合面（20，60）将与第一骨结构（2）和第二骨结构（3）之中的至少一个的骨关节面发生骨融合以达到远期稳定。

Description

融合假体 技术领域 本发明涉及骨科植入领域， 更具体地， 涉及一种融合假体。 背景技术 脊柱是人体的中轴支柱， 上部与颅骨底部的枕骨相连、 下部直达尾骨末端。 脊柱 由椎骨、 骶骨和尾骨借助椎间盘、 椎间关节及诸多韧带连接， 是躯干的活动中心和力 学传递的枢纽， 承担着支持体重、 减震、 保护中枢神经系统、 提供身体上半部分的前 后伸屈、 侧弯、 扭转等运动功能。 由于现代人类生活方式的变化， 生活节奏的加快， 导致脊柱即周围组织的负载加剧， 损伤机会大为增加， 脊柱发病的几率不断上升。 常 见的脊柱疾病如创伤、 肿瘤、 先天畸形、 结核、 类风湿关节炎等等病变所导致的脊椎 椎体损伤及缺失时有发生， 当前解决椎体缺失的办法主要有植骨填充、 人工椎体置换 等方法， 并辅之以前路或后路的钉板、 钉棒内固定。 但现有技术存在的问题是人工椎体与上下相邻节段的生理椎体之间需要持续的压 力以保持紧密接触防止植入物与相邻椎体间移位滑脱， 因此必须另行植入一套保持压 力的刚性的钉板或钉棒系统， 而这一类的固定系统通常会高出原有生理椎体表面而对 周围神经、 血运和软组织带来不利影响； 另外刚性固定系统与生理骨质的弹性模量差 异过大且无法融合成一体， 因此远期容易产生疲劳断裂。 特别需要指出的是某些特定阶段的椎体关节例如寰枢关节， 寰枢关节是连接颅骨 与脊柱的非常特殊而重要的脊椎结构， 由于其所处部位及其解剖结构极其特殊， 一旦 由于病变造成枢椎缺失时常规颈椎人工椎体无法适用， 目前尚没有针对性的假体植入 替代方案， 临床中只能由医生根据具体情况临时采用改造钛笼或钛网的办法加之自体 或异体骨进行植骨融合， 且术后需要较长时间的头颈肩部固定直至完全融合， 给病人 的生活带来极大不便。 发明内容 本发明目的在于提供一种能够替代人体的骨结构从而可以植入人体的融合假体。 根据本发明的融合假体， 设置在第一骨结构和第二骨结构之间以替代第一骨结构 和第二骨结构之间的骨结构， 融合假体包括假体主体和设置在假体主体上的假体融合 面， 假体融合面与第一骨结构和第二骨结构之中的至少一个相贴合， 假体融合面的表 面具有微孔结构。 进一步地， 微孔结构为包括多个相互连通的微孔隙的多向微孔隙结构。 进一步地， 微孔结构的孔隙的孔径为 ΙΟΟμιη至 1800μιη。 进一步地， 融合假体为枢椎融合假体， 用于替代寰椎与第三颈椎之间的枢椎， 假 体融合面包括设置在假体主体上端并与寰椎相贴合的上关节融合面。 进一步地， 枢椎融合假体在植入人体后其正前方表面位于原枢椎正前方生理表面 以内。 进一步地， 假体主体上设置有多个倾斜并向上延伸的第三连接孔， 枢椎融合假体 通过固定件分别与寰椎和第三颈椎相连接。 进一步地，假体主体的上关节融合面上对应原枢椎的齿突位置处设置有齿突凸台。 进一步地， 假体主体的上端对应于寰椎的寰椎前弓外侧的侧块的位置设置有立面 板， 立面板与齿突凸台一起形成对寰椎前弓的夹持。 进一步地， 立面板为两个并分别对应于寰椎前弓外侧的左右两个侧块， 立面板上 分别设置有第一连接孔。 进一步地， 假体融合面还包括设置在假体主体下端并与第三颈椎相贴合的下关节 融合面。 进一步地， 下关节融合面上设置有一个或者多个第二连接孔。 进一步地， 假体主体的表面和 /或内部设置有加强部。 进一步地， 融合假体设置在寰椎与第三颈椎之间以替代枢椎， 融合假体植入人体 后其总体占位高度与原生理枢椎关节一致或者向下延伸加长以替代枢椎和第三颈椎或 者替代更多颈椎椎体节段。 进一步地， 假体主体为微孔结构。 进一步地， 假体主体上设置有多个植骨孔， 多个植骨孔之间相互贯通或者通过微 孔结构相连通。 进一步地， 植骨孔的孔径为 2mm至 30mm。 采用本发明的融合假体， 其假体主体是根据患者的 CT/MRI/UCT等断层扫描数据 制作的等尺寸金属植入物， 该融合假体上设有假体融合面， 假体融合面依据被替代的 骨结构建造并与第一骨结构以及第二骨结构之中的至少一个良好吻合， 假体融合面表 面为便于骨细胞长入的微孔结构， 该微孔结构是一种相互连通的多向微孔隙结构， 该 孔隙有利于骨细胞爬行长入， 术后融合假体的假体融合面将与第一骨结构和第二骨结 构之中的至少一个的骨关节面发生骨融合以达到远期稳定。 附图说明 构成本申请的一部分的附图用来提供对本发明的进一步理解， 本发明的示意性实 施例及其说明用于解释本发明， 并不构成对本发明的不当限定。 在附图中： 图 1是根据本发明的融合假体的立体结构示意图； 图 2是根据本发明的融合假体的微孔结构示意图； 图 3是根据本发明的融合假体与枢椎的连接以及分解结构示意图； 图 4是根据本发明的融合假体与枢椎的通过螺钉连接的结构示意图； 图 5是根据本发明的融合假体与螺钉的分解结构示意图； 图 6是根据本发明的融合假体的植骨孔的结构示意图； 图 7是根据本发明的融合假体的延伸加长实施例的结构示意图； 以及 图 8是根据本发明的融合假体的延伸加长实施例的应用状态的结构示意图。 具体实施方式 下面将参考附图并结合实施例来详细说明本发明。 如图 1所示的根据本发明的融合假体 1， 设置在第一骨结构 2和第二骨结构 3之 间以替代第一骨结构 2和第二骨结构 3之间的骨结构， 融合假体 1包括假体主体 10 和设置在假体主体 10上的假体融合面， 假体融合面与第一骨结构 2和第二骨结构 3 之中的至少一个相贴合， 假体融合面的表面为微孔结构， 微孔结构为多个相互连通的 多向微孔隙结构。 采用本发明的融合假体 1，其假体主体 10是根据患者的 CT/MRI/UCT等断层扫描 数据制作的等尺寸医用金属植入物， 融合假体 1 由医用金属制成， 因此其具有良好生 物相容性。 该融合假体 1上设有假体融合面， 假体融合面依据被替代的骨结构建造并 与第一骨结构 2以及第二骨结构 3之中的至少一个良好吻合， 假体融合面表面为便于 骨细胞长入的微孔结构 30， 微孔结构 30的孔隙的直径为 ΙΟΟμιη至 1800μιη。 如图 2 所示， 该微孔结构 30是一种相互连通的多向微孔隙结构， 该孔隙有利于骨细胞爬行长 入， 术后融合假体 1的假体融合面将与第一骨结构 2和第二骨结构 3之中的至少一个 的骨关节面发生骨融合以达到远期稳定。 优选地， 融合假体 1的两端均具有分别与第 一骨结构 2和第二骨结构 3相贴合的假体融合面。 优选地，假体主体 10为医用金属制成微孔结构， 该微孔结构的表面及内部孔隙相 互贯通， 微孔结构的孔隙孔径 ΙΟΟμιη至 1800μιη。 如图 3所示， 根据本发明的融合假体 1为枢椎融合假体， 设置在第一骨结构 2和 第二骨结构 3之间以替代枢椎。 本实施例中， 第一骨结构 2为寰椎， 第二骨结构 3为 第三颈椎。 假体融合面包括设置在假体主体 10 上端并与寰椎相贴合的上关节融合面 20。优选地，假体融合面还包括设置在假体主体 10下端并与第三颈椎相贴合的下关节 融合面 60。 出于手术入路的需要， 枢椎融合假体可不保留横突、 棘突、 椎弓结构， 除必要的 功能性设计改变外， 该枢椎融合假体在尺寸上与患者原生理枢椎椎体保持基本一致。 枢椎融合假体上下两端分别设有上关节融合面 20和下关节融合面 60， 上关节融合面 20和下关节融合面 60是分别提取寰椎下关节面和第三颈椎上关节面的曲面数据后由 数控机床加工， 也可以利用激光烧结或高能电子束熔融等快速成型技术建造具有曲面 高度拟合特性的表面，枢椎融合假体的上关节融合面 20依据寰椎下关节面数据建造并 与寰椎下关节面良好吻合，枢椎融合假体的下关节融合面 60依据第三颈椎上关节面数 据建造并与第三颈椎上关节面良好吻合。 由于上关节融合面 20和下关节融合面 60的 表面均为微孔结构， 手术后枢椎融合假体的上关节融合面 20和下关节融合面 60将分 别与寰椎和第三颈椎的骨关节面发生骨融合以达到远期稳定。 如图 1所示， 根据枢椎融合假体的一个实施例， 假体主体 10的上关节融合面 20 上对应原枢椎的齿突位置处设置有齿突凸台 40。 假体主体 10的上端对应于寰椎的寰 椎前弓外侧的侧块的位置设置有立面板 50， 用于与齿突凸台 40—起形成对寰椎前弓 的夹持。优选地， 立面板 50为两个并分别对应于寰椎前弓外侧的左右两个侧块， 立面 板 50上分别设置有第一连接孔 51。 齿突凸台 40外表面以及立面板 50内侧与寰椎侧块接触的内表面均为便于骨细胞 长入的微孔结构 30， 该微孔结构 30是一种相互连通的多向微孔隙结构， 孔隙直径为 ΙΟΟμιη至 1800μιη， 该孔隙有利于骨细胞爬行长入， 手术后齿突凸台 40将与寰椎前弓 内侧的寰椎齿突凹发生骨融合、 立面板 50 内表面的微孔结构将与寰椎侧块发生骨融 合， 从而使得融合假体与寰椎相结合并达到远期稳定。 如图 4和图 5所示， 手术中将 连接件 90分别由两个第一连接孔 51中旋入寰椎侧块以达到初始稳定的目的， 待骨融 合完成后即可达到颈椎稳定的重建。 在本实施例中， 连接件 90为固定螺钉。 根据枢椎融合假体的另一个实施例， 如图 5所示， 所述枢椎融合假体在植入人体 后其正前方表面位于原枢椎正前方生理表面以内。 在本实施例中，枢椎融合假体上端对应于寰椎前弓下缘处设置有凹槽 11并与寰椎 前弓下缘良好嵌合， 假体主体 10上设置有多个倾斜并向上延伸的第三连接孔 62， 枢 椎融合假体通过固定件 90分别与寰椎和第三颈椎相连接。 具体地， 第三连接孔 62为 螺钉孔， 固定件 90为固定螺钉。枢椎融合假体对应于寰椎前弓外侧左右两个侧块位置 的下方各自设有一个螺钉孔， 手术中将固定螺钉分别由两个螺钉孔旋入寰椎侧块以达 到初始稳定的目的。枢椎融合假体的假体主体 10上端的对应于寰椎前弓下缘处的凹槽 11与寰椎下缘接触的部位的凹槽表面为微孔结构， 该微孔结构是一种相互连通的多向 微孔隙结构， 孔隙直径为 ΙΟΟμιη至 1800μιη， 该孔隙有利于骨细胞爬行长入， 术后枢 椎融合假体的假体主体 10上端对应于寰椎前弓下缘处的凹槽 11内表面的微孔结构将 与寰椎前弓下缘发生骨融合以达到远期稳定。 在本实施例中， 枢椎融合假体在植入人体后其正前方表面位于原枢椎正前方生理 表面以内， 即枢椎融合假体在植入后其正前方表面不突出于原枢椎正前方生理表面， 也即达到医学界所说的零切迹， 如此设计的有利之处在于术后寰椎、 枢椎融合假体、 第三颈椎的正前方椎体表面将形成一个无明显突出部位的近乎连续的颈椎前表面， 对 枢椎前方各种软组织解剖位置无任何不良影响， 以避免以往常规颈椎前路钢板固定时 因被植入的人工椎体部件明显突出于原生理椎体前表面而导致患者呼吸 、吞咽、语言 沟通时的异物感与不适。 如图 1所示， 下关节融合面 60上设置有一个或者多个第二连接孔 61。 根据本发明的一个实施例，假体主体 10下端对应于第三颈椎上关节面的假体融合 面为便于骨细胞长入的微孔结构， 该孔隙有利于骨细胞爬行长入， 术后枢椎融合假体 下端对应于第三颈椎上关节面的假体融合面将与第三颈椎上关节面发生骨融合以达到 远期稳定。 枢椎融合假体下端对应于第三颈椎上关节面的假体融合面上设有 1至 3个 螺钉孔。 如图 4和图 5所示， 手术中将固定螺钉 90分别由第二连接孔 61中旋入第三 颈椎上关节面以达到初始稳定的目的， 待骨融合完成后即可达到颈椎稳定的重建。 如图 6和图 7所示， 假体主体 10上设置有多个植骨孔 80， 多个植骨孔 80之间相 互贯通或者通过微孔结构相连通。 在枢椎融合假体主体上设有若干植骨孔 80， 该植骨孔 80可以容纳自体或异体骨 块和骨颗粒，术前或术中在该植骨孔 80内植入自体或异体骨块和骨颗粒可以起到诱导 骨细胞爬行长入促进骨融合的作用， 植骨孔孔径为 2mm至 30mm， 以方便不同直径的 自体或异体骨块和骨颗粒植入。 前述融合假体的主体表面和 /或内部的全部或局部涂敷有羟基磷灰石涂层， 该羟基 磷灰石涂层采用等离子喷涂法或电化学沉积法以及烧结法形成。 另外， 枢椎融合假体设置在寰椎与第三颈椎之间以替代枢椎， 融合假体植入人体 后其总体占位高度与原生理枢椎关节一致。 假体主体 10的表面和 /或内部设置有加强部， 加强部为加强筋或加强板， 以强化 假体主体 10的结构强度。 如图 7和图 8所示，当患者枢椎及第三颈椎或更多颈椎阶段均需要由假体替代时， 融合假体向下延伸加长以涵盖替代第三颈椎 4直至更多的颈椎椎体节段， 此时融合假 体将与第四或其他节段颈椎椎体衔接固定， 其固定融合方式与上述与第三颈椎对接固 定的方式相同。 枢椎融合假体的加工方法是： 获得患者颈椎部位 CT/MRI/UCT等断层扫描数据— 在计算机中建立颈椎病变部位的三维数据模型—提取枢椎模型并进行修改设计生成枢 椎融合假体三维数据模型—用枢椎融合假体三维数据模型模拟替代生理枢椎以检查并 验证设计方案—加工成型。 根据目前的加工技术有两条较理想的加工路径：
A、 采用数控加工机床依据在计算机中生成的枢椎融合假体数据转换成的加工程 序进行加工成型， 然后使用电火花加工、 化学腐蚀、 机械钻孔切削等方法加工钻铣出 所需要的植骨孔、螺钉孔与微孔， 固定螺钉则采用车削或铣等常规机械加工方法制作；
B、 利用激光烧结或高能电子束熔融等快速成型技术熔融成型， 具体方法如下： a) 使用专业软件对在计算机中设计建造的枢椎融合假体三维数据模型进行分层， 以获得一系列单层切片的轮廓数据； b) 向激光或高能电子束快速成型设备输入上述系列层片数据；
C )在激光或高能电子束快速成型设备加工舱内铺设与前述三维数据模型分层时层 高相应厚度的医用金属粉末； d) 由计算机控制激光束或高能电子束对医用金属粉末进行扫描并有选择的熔化； e)重复前述铺设粉末、扫描熔化步骤以使各层被选择熔化的材料相互熔结成整体; f)完成全部层面的熔融过程后去除未熔融的粉末即可得到所需要形状结构的枢椎 融合假体； g) 由于在建造枢椎融合假体三维数据模型时已经将所需要的实体、植骨孔、螺钉 孔、 微孔等等结构一并设计在数据文件中， 因此上述各种结构在激光烧结或高能电子 束熔融过程中将一次性完成制造。 从以上的描述中， 可以看出， 本发明上述的实施例实现了如下技术效果： 本发明的融合假体， 假体融合面表面为便于骨细胞长入的微孔结构， 该微孔结构 是一种相互连通的多向微孔隙结构， 该孔隙有利于骨细胞爬行长入， 术后融合假体的 假体融合面将与第一骨结构和第二骨结构之中的至少一个的骨关节面发生骨融合以达 到远期稳定。 以上所述仅为本发明的优选实施例而已， 并不用于限制本发明， 对于本领域的技 术人员来说， 本发明可以有各种更改和变化。 凡在本发明的精神和原则之内， 所作的 任何修改、 等同替换、 改进等， 均应包含在本发明的保护范围之内。

Claims

权 利 要 求 书
1. 一种融合假体， 设置在第一骨结构 （2) 和第二骨结构 （3 ) 之间以替代所述第 一骨结构 （2) 和所述第二骨结构 （3 ) 之间的骨结构， 其特征在于， 所述融合 假体包括假体主体 （10) 和设置在所述假体主体 （10) 上的假体融合面， 所述 假体融合面与所述第一骨结构 （2) 和所述第二骨结构 （3 ) 之中的至少一个相 贴合， 所述假体融合面具有微孔结构 （30)。
2. 根据权利要求 1所述的融合假体， 其特征在于， 所述微孔结构 （30) 为包括多 个相互连通的微孔隙的多向微孔隙结构。
3. 根据权利要求 2所述的融合假体， 其特征在于， 所述微孔结构 （30) 的孔隙的 孔径为 ΙΟΟμιη至 1800μιη。
4. 根据权利要求 2所述的融合假体，其特征在于，所述融合假体为枢椎融合假体， 用于替代寰椎与第三颈椎之间的枢椎， 所述假体融合面包括设置在所述假体主 体 （10) 上端并与所述寰椎相贴合的上关节融合面 （20)。
5. 根据权利要求 4所述的融合假体， 其特征在于， 所述假体主体 （10) 的上关节 融合面 （20) 上对应原枢椎的齿突位置处设置有齿突凸台 （40)。
6. 根据权利要求 5所述的融合假体， 其特征在于， 所述枢椎融合假体在植入人体 后其正前方表面位于原枢椎正前方生理表面以内。
7. 根据权利要求 6所述的融合假体， 其特征在于， 所述假体主体 （10) 上设置有 多个倾斜并向上延伸的第三连接孔 （62)， 所述枢椎融合假体通过固定件 （90) 分别与寰椎和第三颈椎相连接。
8. 根据权利要求 5所述的融合假体， 其特征在于， 所述假体主体 （10) 的上端对 应于所述寰椎的寰椎前弓外侧的侧块的位置设置有立面板 （50)， 所述立面板
( 50) 与所述齿突凸台 （40) —起形成对所述寰椎前弓的夹持。
9. 根据权利要求 8所述的融合假体， 其特征在于， 所述立面板 （50) 为两个并分 别对应于所述寰椎前弓外侧的左右两个侧块， 所述立面板 （50) 上分别设置有 第一连接孔 （51 )。
10. 根据权利要求 4所述的融合假体， 其特征在于， 所述假体融合面还包括设置在 所述假体主体 （10) 下端并与所述第三颈椎相贴合的下关节融合面 （60)。
11. 根据权利要求 10所述的融合假体， 其特征在于， 所述下关节融合面（60)上设 置有一个或者多个第二连接孔 （61 )。
12. 根据权利要求 2所述的融合假体， 其特征在于， 所述假体主体（10) 的表面和 / 或内部设置有加强部。
13. 根据权利要求 2所述的融合假体， 其特征在于， 所述融合假体设置在寰椎与第 三颈椎之间以替代枢椎， 所述融合假体植入人体后其总体占位高度与原生理枢 椎关节一致或者向下延伸加长以替代枢椎和第三颈椎或者替代更多颈椎椎体节 段。
14. 根据权利要求 1至 13中任一项所述的融合假体，其特征在于，所述假体主体（10) 为微孔结构。
15. 根据权利要求 14所述的融合假体， 其特征在于， 所述假体主体（10)上设置有 多个植骨孔（80)， 多个所述植骨孔（80)之间相互贯通或者通过所述微孔结构 相连通。 根据权利要求 15 所述的融合假体， 其特征在于， 所述植骨孔 （80) 的孔径为 2mm至 30mm。
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