WO2013000138A1 - 一种可调式人工颈椎及椎间连接复合体 - Google Patents

一种可调式人工颈椎及椎间连接复合体 Download PDF

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Publication number
WO2013000138A1
WO2013000138A1 PCT/CN2011/076587 CN2011076587W WO2013000138A1 WO 2013000138 A1 WO2013000138 A1 WO 2013000138A1 CN 2011076587 W CN2011076587 W CN 2011076587W WO 2013000138 A1 WO2013000138 A1 WO 2013000138A1
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WO
WIPO (PCT)
Prior art keywords
vertebral body
body member
end plate
intervertebral
cervical
Prior art date
Application number
PCT/CN2011/076587
Other languages
English (en)
French (fr)
Inventor
贺西京
秦杰
Original Assignee
西安交通大学
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 西安交通大学 filed Critical 西安交通大学
Priority to US14/129,966 priority Critical patent/US9452062B2/en
Priority to PCT/CN2011/076587 priority patent/WO2013000138A1/zh
Publication of WO2013000138A1 publication Critical patent/WO2013000138A1/zh

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    • 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
    • A61F2/3094—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
    • A61F2/28—Bones
    • A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
    • 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
    • A61F2002/30383—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
    • A61F2002/30387—Dovetail connection
    • 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
    • A61F2002/30383—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
    • A61F2002/3039—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove with possibility of relative movement of the rib within the groove
    • A61F2002/30392—Rotation
    • 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
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30383—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
    • A61F2002/3039—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove with possibility of relative movement of the rib within the groove
    • A61F2002/30398—Sliding
    • A61F2002/304—Sliding with additional means for limiting said sliding
    • 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
    • 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
    • A61F2002/30535—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
    • 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
    • A61F2002/30535—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
    • 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
    • A61F2002/30535—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
    • 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
    • A61F2002/30621—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
    • A61F2002/30772—Apertures or holes, e.g. of circular cross section
    • A61F2002/30784—Plurality of holes
    • A61F2002/30785—Plurality of holes parallel
    • 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
    • A61F2002/30841—Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
    • 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
    • A61F2310/00005—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
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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
    • 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

Definitions

  • the invention belongs to the technical field of medical prosthesis manufacturing, and relates to a composite body of artificial cervical vertebrae and intervertebral joints with adjustable length.
  • anterior disc nucleus pulposus removal subtotal decompression and interbody fusion is the most important and the most advantageous surgical procedure. Its advantages include a more complete decompression than a simple discectomy, and a high fusion rate.
  • Anterior interbody fusion methods include autologous bone, allogeneic bone and artificial vertebral body fusion. Since autologous bone graft has good osteoinductivity, osteoconductivity and bone formation, it is the gold standard for bone graft fusion. The advantage of autologous bone graft fusion is that it is not immunogenic and the fusion speed is fast. Disadvantages are high postoperative height loss rate and secondary damage in the bone extraction area (eg bleeding, fractures, infections, etc.). Allogeneic bone grafting avoids these shortcomings, but is immunogenic and slower to fuse (often required
  • Simple support type artificial vertebral body The support artificial vertebral body and the upper and lower vertebral body are mainly fixed according to the bone cement filled therein. The purpose is to fill the bone defect after vertebral body resection, and the fixation effect is poor.
  • Adjustable fixed artificial vertebral body domestic and foreign scholars have developed adjustable fixed artificial vertebral bodies with various characteristics, which have been applied in clinical practice and have achieved certain curative effects.
  • the Synex artificial vertebral body is a titanium hollow network structure with adjustable length. Knop et al. used it for the reconstruction of thoracolumbar anterior column injury, which can provide good three-dimensional stability of the spine.
  • Knop et al. used it for the reconstruction of thoracolumbar anterior column injury, which can provide good three-dimensional stability of the spine.
  • due to the adjustment of Synex artificial vertebral body length it is difficult to implant from the posterior approach, and the technical requirements are high.
  • the inside can be bone grafted, and the prosthesis and the vertebral body form a permanent bone fusion.
  • the spikes are fixed in contact with the upper and lower vertebral bodies, and the prosthesis is rigidly fixed, and there are problems such as stress shielding and bone resorption of the implanted bone.
  • Recognized contraindications include osteoporosis and intervertebral instability (Wiffield CC, Skrzyp iec D, Jackowski A, et al. Internal stress distribution in cervical intervertebral discs: the influence of an artificial cervical joint and simulated anterior interbody fusion [ J ].J Spinal Disord Tech, 2003, 16 (5): 441- 449.). Although the materials and shapes of various artificial intervertebral discs are different, their common shortcomings are as follows: 1. The intervertebral disc can only be replaced alone, but it is incapable of combining vertebral lesions (such as vertebral tumors, and decompression of the vertebral body is required). Surgery). Second, most scholars do not agree with multi-segmental disc replacement, especially the simultaneous replacement of two adjacent discs.
  • the current technology can not solve the problem of mobility after cervical surgery, especially the problem of inability to move after multiple segments of surgery, and the resulting degeneration of adjacent segments after fusion. . Therefore, the present application has developed the following artificial cervical vertebral body and intervertebral junction complex with adjustable length of the artificial vertebral body and the movable performance of the artificial 90 intervertebral disc.
  • the object of the present invention is to overcome the above-mentioned shortcomings of the prior art, and to provide an adjustable artificial cervical vertebra and intervertebral junction complex, which has the supporting function of the artificial vertebral body and the movable performance and length of the artificial intervertebral disc. It can realize the immediate stability of the anterior cervical spine after 95, can play a supporting role, and can also realize the immediate motor function reconstruction after the anterior cervical spine, so that its activity performance and the normal cervical spine height bionic.
  • the adjustable artificial cervical vertebrae and intervertebral junction complex comprising a vertebral body member and two endplate members respectively connected to the upper and lower ends of the vertebral body member through a ball joint structure;
  • the vertebral body 100 component consists of an upper vertebral body member and a lower vertebra a body member, the upper vertebral body member and the lower vertebral body member are axially connected by a thread; and a plurality of screw holes are radially disposed on the side peripheral wall of the upper vertebral body member and the lower vertebral body member, and the upper vertebral body is provided
  • a length fixing screw is further disposed between the screw hole of the component and the lower vertebral body member; and the end plate member fixing screws are respectively disposed on the two end plate members.
  • the ball joint structure includes an articulated ball structure and a setting disposed on the end plate member
  • a mouthwash structure adapted to the joint ball structure at an end of the upper or lower vertebral body member, the internal space of the cornice structure being a central cylindrical space and a hemisphere intersecting the two sides of the cylindrical space
  • the composition of the space; and the inside of the cornice structure is large and the outlet is small, and the joint ball structure is enclosed therein.
  • the end plate member includes a circular plate, and the joint ball is vertically fixed on the inner side edge of the circular plate
  • the outer side of the disc passes through the phase at a position away from the fixed position of the joint ball structure
  • Two adjacent end plate member fixing screws are fixed to the two adjacent screw holes; the axial direction of the end plate member fixing screws is at an angle to the plane of the circular plate.
  • the upper surface of the above disc is a matte-like rough structure and is provided with a bio-hydroxyapatite coating.
  • the thickness of the above hydroxyapatite coating is ⁇ ⁇ ⁇ , and the second half of the surface of the circular plate has a small tooth structure of 1 ⁇ m in size.
  • the thickness of the disc is thicker on the side of the fixing end plate member fixing screw and thicker on the side of the fixed joint ball structure, and all the faces are formed from the side of the circular plate, and the cutting surface starts from the center line of the end plate structure.
  • a 10° section is formed which forms an 80° slope with the adjacent upper vertebral body and a slope of 100 with the adjacent lower vertebral body.
  • the lower constriction of the upper vertebral body member is provided with an external thread
  • the upper end of the lower vertebral body member is a cylindrical structure provided with an internal thread
  • the lower constricted end of the upper vertebral body member is screwed into the lower vertebral body member.
  • Inside the internal thread a plurality of radial threaded through holes are evenly distributed in the axial direction of the upper and lower vertebral members, and the length fixing screw can be screwed into the threaded through hole to fix the upper vertebral body member The relative position of the lower vertebral body member in the axial direction.
  • the entire composite has a minimum length of 23mm, a maximum length of 29mm, and an adjustment range of 6mm.
  • the front end of the end plate member fixing screw is a pointed end, and the rear end of the fixing screw is a nut, and the near nut end of the fixing screw is slightly thicker than the proximal end of the fixing screw.
  • the invention can play a supporting role immediately after the anterior cervical spine surgery, and
  • the intervertebral connection portion replaces the motor function of the normal cervical vertebra, and can effectively prevent the degeneration of adjacent segments caused by the fusion surgery.
  • biological fusion and long-term stability can be achieved by grafting the hydroxyl-based apatite coating on the surface of the composite. The operation is less difficult, the trauma is small, and it is easy to promote. Due to the adjustability of the length of the composite itself, the production and carrying burden can be reduced, and it can be adapted to most people.
  • Figure 1 is a schematic view of the overall structure of the present invention
  • Figure 2 is a schematic view showing the structure of the upper vertebral body member 2 of the present invention.
  • Figure 3 is a plan view of Figure 2;
  • Figure 4 is a schematic view showing the structure of the lower vertebral body member 3 of the present invention.
  • Figure 5 is a schematic view showing the structure of the end plate member 1 of the present invention.
  • Figure 6 is a plan view of Figure 5;
  • 1 is the end plate component
  • 2 is the upper vertebral body component
  • 3 is the lower vertebral body component
  • 4 is the end plate component fixing screw
  • 5 is the length fixing screw
  • 6 is the joint ball structure
  • 7 is the screw hole
  • 9 is a circular plate
  • 10 is a cornice structure.
  • the adjustable artificial cervical vertebrae and intervertebral junction complex of the present invention comprises a vertebral body member and two endplate members 1 respectively connected to the upper and lower ends of the vertebral body member through a ball joint structure;
  • the vertebral body member is composed of the upper vertebral body
  • the component 2 and the lower vertebral body member 3 are composed, wherein the upper vertebral body member 2 and the lower vertebral body member 3 are axially connected by a screw; and a plurality of radial corresponding portions are provided on the side peripheral walls of the upper vertebral body member 2 and the lower vertebral body member 3 Screw hole in upper vertebral part 2 and lower vertebral body 155
  • a length fixing screw 5 is further disposed between the screw holes of the member 3; the end plate member fixing screws 4 are respectively disposed on the two end plate members 1.
  • the ball joint structure described above includes an articulated ball structure 6 disposed on the end plate member 1 and a 3 end of the upper vertebral body member 2 or the lower vertebral body portion 160.
  • a mouthwash structure 10 adapted to the joint ball structure 6, the inner space of the mouthpiece structure 10 being composed of a central cylindrical space and a hemispherical space intersecting both sides of the cylindrical space; and the inside of the cornice structure 10 is large
  • the outlet is small and the joint ball structure 6 is enclosed therein.
  • the joint ball structure 6 and the jaw structure 10 cooperate to realize the four degrees of freedom of the intervertebral connection.
  • the joint ball structure 6 is made of a sphere having a diameter of 4 mm
  • the joint ball structure 6 coincides with the mouth structure 10 of the upper and lower vertebral members, respectively.
  • the upper and lower jaw structures 10 are completely coincident with the joint ball structure 6 on the left and right sides (i.e., 4 mm in diameter).
  • the cornice structure 10 is made up of a circle with a diameter of 4 mm along the X axis (ie, the horizontal plane along the midpoint of the anterior and posterior edge of the vertebral body)
  • intervertebral connections have the following advantages: 1. 85% matching can form more than half of the joint anastomosis, ensuring the absolute stability of the intervertebral connection, and does not cause joint dislocation after implantation;
  • the center of the intervertebral connection activity is slightly behind the middle column of the vertebral body, which conforms to the axis of motion of the normal spine. After implantation, it has little effect on the biomechanical properties of the spine; 3.
  • the intervertebral space The connection can achieve 4 degrees of freedom of activity.
  • the line connecting the midpoint of the anterior and posterior edge of the vertebral body on the horizontal plane is the X axis, and the line connecting the midpoint of the left and right edges of the vertebral body on the horizontal plane is the Y axis, and the vertical direction is the Z axis. )
  • the connection can achieve 4 degrees of freedom of activity.
  • the line connecting the midpoint of the anterior and posterior edge of the vertebral body on the horizontal plane is the X axis
  • the line connecting the midpoint of the left and right edges of the vertebral body on the horizontal plane is the Y axis
  • the vertical direction is the Z axis.
  • the left and right rotation can also be maintained at 15 to 20 ° (ie, rotating along the Z axis) due to the restriction of the posterior column of the spine, and the translation is about 1.5 mm (ie, translation along the X axis) .
  • the most important of these is that the intervertebral connection can achieve the function of front and rear translation that is impossible with almost all artificial intervertebral discs and artificial vertebral bodies.
  • Most of the literature confirms that the human spine is capable of flexion, extension, left and right lateral flexion, and left and right rotation.
  • the 185 can perform the anterior-posterior translation of the upper and lower vertebral bodies, which has a positive effect on preventing the degeneration of the intervertebral disc and the cervical vertebrae.
  • the distance between the front and rear translation should not be too large. If it is too large, the vertebral body will be unstable. Therefore, the intervertebral connection formed by the uniquely designed socket structure allows about 1.5 mm of anteroposterior translation between the upper and lower vertebral bodies. It can maximize the biopsy of the human cervical spine and inhibit the postoperative degeneration of cervical disease.
  • the end plate member 1 includes a circular plate 9 on which the joint ball structure 6 is vertically fixed, and the outer side surface of the circular plate 9 is at a fixed position away from the joint ball structure 6.
  • Two end plate member fixing screws 4 are fixed by two adjacent screw holes 7; the axial direction of the end plate member fixing screws 4 is at an angle to the plane of the circular plate 9 (as shown in Fig. 1).
  • the plate thickness of the circular plate 9 is thin on the side of the fixing end plate member fixing screw 4,
  • the front half of the disc 9 of the end plate member 1 is thinner than the rear half, forming a cut from the side
  • the angle of the face is about 10°, and the cut surface starts from the center line of the circular plate 9 in the front-down direction.
  • the cut surface forms an 80° slope with the adjacent upper vertebral body and a 100° slope with the adjacent lower vertebral body.
  • These two bevels are very beneficial for the close fitting of the endplates of the upper and lower vertebral bodies adjacent to the vertebral body.
  • the end plate fixing screw 4 of the present invention has a pointed end with a nut end (shown in Fig. 1), and the near nut end of the end plate member fixing screw 4 is slightly thicker than the proximal end of the end plate.
  • the endplate component set screw 4 can be placed into the adjacent vertebral body at an angle of 20° to the vertebral body adjacent to the vertebral body.
  • the near-nut end of the end plate component fixing screw 4 is engaged with the screw hole 7, and the screw-hole 7 has an internal thread structure, and the longer end plate member fixing screw 4 is attached.
  • the complex can be stably fixed on the vertebral body adjacent to the vertebral body to achieve immediate stability and play the supporting role of the vertebral body.
  • the fixing method is longer than the front screw fixing, and the screw is inserted deeper and more biomechanical.
  • the nail body of the end plate member fixing screw 4 is designed to be thin at the front end, and the end portion of the rear end and the screw hole 7 is slightly thick, because the structure is such that the end plate member fixing screw 4 is screwed by the screw hole 7 When penetrating,
  • the angle of the end plate component fixing screw 4 can be conveniently adjusted. When the end plate component fixing screw 4 is tapped into the adjacent vertebral body, the near nut end is just screwed with the screw hole 7 to thereby end the end plate component. The angle of the set screw 4 is locked.
  • the upper surface of the circular plate 9 is a matte-like rough structure, and has a bio-hydroxyapatite coating formed by plasma oxidation technology, and has a coating thickness of about ⁇ ⁇ ⁇ , upper surface.
  • the rear half of 220 has a small tooth structure 8 of about 1 ⁇ m in size. All upper surface treatments are available To accelerate the early fusion of the endplate structure with adjacent vertebral bodies, it is beneficial to achieve bio-fusion and long-term stability.
  • the lower portion of the upper vertebral body member 2 is necked and provided with an outer thread, and the upper end of the lower vertebral body member 3 is a cylindrical structure having an internal thread, and the lower portion of the upper vertebral body member 2
  • the 225 neck end is threaded into the internal thread of the lower vertebral body member 3; a plurality of radial threaded holes 11 and 12 are evenly distributed in the axial direction of the upper vertebral body member 2 and the lower vertebral body member 3 (Fig. 2, 3 In the case of having three radial threaded holes 11, 12), the length fixing screw 5 can be threaded into the threaded hole to fix the relative position of the upper vertebral body member 2 and the lower vertebral body member 3 in the axial direction.
  • the lower vertebral body member 3 is composed of a hollow cylindrical structure having an upper portion (about 12 mm in diameter, about 10 mm in height and a wall thickness of about 2 mm) and a solid cylindrical portion having a lower portion (about 12 mm in diameter and about 4 mm in height) (see Fig. 4).
  • the upper hollow cylindrical structure has a 2mm diameter fixing hole directly in front of it, with internal thread. There are four continuous fusion screw holes on the left and right sides, the diameter is
  • the outer surface of the lower vertebral body member 3 is coated with a biological hydroxyapatite coating having a thickness of about 1 m which is treated by a plasma oxidation technique.
  • the lower center has the aforementioned cornice structure 10, the lower dotted line shows the position of the cornice structure 10, and the cornice structure 10 matches the joint ball structure 6 of the lower end plate member 1.
  • the upper and lower sides of the upper vertebral body member 2 have four fusion screw holes 12, and the upper and lower sides of the lower vertebral body member 3 also have four fusion screw holes 15 respectively.
  • the holes are 2 mm in diameter and are not threaded.
  • the broken bone filled in the lower hollow cylindrical structure of the upper vertebral body member 2 can grow along the fusion screw hole, thereby achieving stable fusion of the stable vertebral body member and the vertebral body.
  • reliable hydroxyapatite coating on the outer surface of the vertebral body and lower vertebral body components can accelerate the postoperative fusion process and achieve biological integration, ensuring long-term stability.
  • the four adjusting screw holes 11 directly in front of the lower portion of the upper vertebral body member 2 and one fixing screw hole directly in front of the 250th portion of the lower vertebral body member 3 are internally threaded to match the vertebral body length fixing screw 5. Since the diameters of the adjusting screw hole and the fixing screw hole are both 2 mm, the fixing screw hole directly in front of the lower vertebral body member 3 coincides with the adjusting screw hole directly in front of the upper vertebral body member 2 every two rotations. At this time, the vertebral body length fixing screw 5 can be screwed in along the fixing screw hole and the adjusting screw hole, depending on the external thread of the lower portion of the upper vertebral body member 2 and the upper portion of the lower vertebral body member 3.
  • the upper vertebral body member 2 and the lower vertebral body member 3 cooperate with each other, and the length of the entire composite body can be adjusted by rotation (the minimum length of the entire composite body is 23 mm, and the maximum length 260 is 29 mm. The adjustment range is 6 mm).
  • the adjustable cervical vertebra and the intervertebral junction complex of the present invention are particularly suitable for treating cervical spondylosis caused by two adjacent cervical disc herniation, and can perform discectomy, subtotal corpectomy, and the present complex. Replacement.
  • the subtotal vertebral incision can be performed and the complex replacement is performed.
  • This complex can be used in a variety of cervical diseases such as 265 disc replacement, revision after artificial cervical disc replacement, and severe degeneration after cervical fusion. The following is a description of the specific embodiment of the procedure for the removal of the disc, subtotal vertebral body resection and the replacement of the complex.
  • the surgical treatment is usually performed. Intratracheal intubation is anesthesia. Position is supine, shoulder pad soft pillow, head naturally leans back
  • the back pillow cushion soft head ring to prevent pressure sores, a small sandbag on each side of the head to prevent intraoperative head rotation.
  • the incision is generally performed by a transverse incision of the neck, exposing the affected vertebra and the intervertebral disc, positioning the needle and positioning the intraoperative C-arm X-ray machine.
  • the cervical vertebral body expander screws are respectively screwed into the center of the upper and lower vertebral bodies of the vertebral body to be subtotal resection, and the distractor is inserted into the distraction screw, and the upper and lower ends are opened.
  • Decompression The nucleus pulposus of the intervertebral disc above and below the vertebral body is cut with a sharp knife.
  • the forceps were used to remove the intervertebral disc tissue.
  • the anterior cortical bone of the vertebral body and most of the cancellous bone were removed with a three-jointed occlusal forceps.
  • the disc was suspended.
  • the disc above and below the vertebral body was completely removed.
  • the curette, rongeur and round head tendon repair the intervertebral articular surface to subchondral hemorrhage, so that the endplates are roughly parallel and the bony endplates are not destroyed.
  • the gap between the posterior margin of the vertebral body and the posterior longitudinal ligament was separated by a nerve stripper, and the posterior marginal cortical bone was bitten by a gun-type rongeur to form a long

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Abstract

一种可调式人工颈椎及颈间连接复合体，包括椎体部件以及分别通过球关节结构连接于椎体部件上下端的两个终板部件（1）。所述椎体部件由上椎体部件（2）和下椎体部件（3）组成，所述上椎体部件（2）和下椎体部件（3）轴向通过螺紋连接。在所述上椎体部件（2）和下椎体部件（3）的侧周壁上径向对应设有若干螺孔（7），在上椎体部件（2）和下椎体部件（3）的螺孔（7）间还设有一个长度固定螺钉（5）。两个终板部件（1）上分别设有终板部件固定螺钉（4）。

Description

一种可调式人工颈椎及椎间连接复合体 技术领域
本发明属于医用假体制造技术领域， 涉及一种长度可调的人工 颈椎椎体和椎间连接的复合体。
背景技术
由于人口老龄化， 伏案工作者及使用电脑者比例增长， 交通事故 发生率增高等因素， 颈椎伤患 （如颈椎病， 颈椎骨折， 颈椎肿瘤等） 的人数随之增长。对于各种颈椎疾病患者的手术治疗， 尤其是颈椎间 盘突出导致的颈椎病及颈椎骨折， 手术的关键有二： 一是减压。 需要 减除压迫脊髓或者神经根的因素， 以促进术后神经功能的早日恢复。 二是稳定。通过各种类型的融合手术， 采用不同的植入材料（如自体 骨、异体骨以及人工椎体等）实现术后手术节段的长期稳定性。其中， 前路椎间盘髓核摘除椎体次全切除减压并椎间融合术是目前最主要 的， 也是最具有应用优势的手术术式。其优点包括减压较单纯椎间盘 摘除术彻底， 融合率高等。 前路椎间融合的方法包括自体骨， 异体骨 及人工椎体植骨融合。 由于自体骨植骨具有良好的骨诱导性、骨传导 性和骨形成性， 所以成为植骨融合的金标准。 自体骨植骨融合术的优 点是没有免疫原性， 且融合速度快。缺点有术后高度丢失率高， 且造 成取骨区的二次损伤 （如供骨区的出血、 骨折、 感染等）。 异体骨植 骨避免了上述缺点， 但存在免疫原性， 以及融合速度较慢（常常需要
6个月甚至 9个月以上）。 为了克服自体骨和异体骨移植的上述缺点，人们一直在寻找脊柱 手术后的替代物， 由此诞生了人工椎体。 1969年， Hamdi首次报告 腰 2浆细胞瘤和转移性腺癌病人施行椎体肿瘤切除，并以人工假体替 代病变椎体 ( Hamdi, F A. Prosthesis for an excised lumbar vertebra: a preliminary report. Can Med Assoc J, 1969, 100, 12: 576-80. )。根据材料 可分为金属人工椎体、新型复合材料人工椎体及其它材料人工椎体三 大类。从结构及功能特点看主要可分为单纯支撑型， 撑开固定型和可 调固定型三种类型。单纯支撑型人工椎体： 支撑型人工椎体与上下椎 体的固定主要是依赖其内填充骨水泥， 目的是填充椎体切除后的骨缺 损， 固定作用较差。 可撑开固定型人工椎体： 这类人工椎体大多是通 过尖刺状物与上下椎体相固定， 能达到脊柱的即刻稳定性。钛网是最 常使用的可撑开固定型人工椎体， 广泛应用于椎体的重建， 但钛网本 身长度固定且不能调节， 因此对椎体的选择很严谨， 否则难以恢复理 想的椎体高度， 而且有脱落的危险。 可调固定型人工椎体： 国内外学 者研制了具有各种特色的可调固定型人工椎体，应用于临床并取得了 一定的疗效。如 Synex人工椎体，为钛质中空网状结构，长度可调节， Knop等将其用于胸腰椎前柱损伤的重建， 可提供良好的脊柱三维稳 定性。但由于 Synex人工椎体长度调整后， 从后路植入困难， 技术要 求高，因此一般行前路或者前后联合入路，手术创伤大、时间久 (Knop, Christian; Lange, Uta; Reinhold, Maximilian; Blauth, Michael. Vertebral body replacement with Synex in combined posteroanterior surgery for treatment of thoracolumbar injuries. Oper Orthop Traumatol.2005,17(3): 249-80.) 赵定麟等 （赵定麟， 陈德上， 赵杰， 等。 可调式中空人工 椎体的研制与临床应用。 中华骨科杂志， 2001,21 :222-224. )研制的中 空可调式钛合金人工椎体， 可以调节人工椎体的长度， 达到理想的恢 复椎体高度的目的， 因为是中空结构， 其内部可以植骨， 使假体与椎 体形成永久骨性融合。但仅有尖刺状物与上下椎体接触固定， 且该假 体呈刚性固定， 存在内植骨的应力遮挡和骨吸收等问题。
这些人工椎体通过各种形状、 材料的调整、 改进， 以期能够简化 手术歩骤， 减少手术创伤， 实现术后的即刻稳定， 加快融合速度。 但 是上述的人工椎体都存在同样的一个问题，就是使用后施术脊柱节段 完全丧失了原有的活动性。 而这被认为会加速术后颈椎的退行性病 变， 导致相邻节段颈椎椎间盘突出、 椎体骨质增生等。 长期随访的结 果显示， 施行颈椎前路融合手术后， 有高达 92%的病人出现了临近节 段的退变， 虽然临床症状并不与 X线上的严重程度一致（G0ffin, Jan, Geusens, Eric, Vantomme, Nicolaas, et al. Long-term follow-up after interbody fusion of the cervical spine. J Spinal Disord Tech,2004,17(2) :79-85. )。 Hilibrand等发现前路融合手术后每年约有 2. 9%的患者出现了与相邻节段退变有关的临床症状， 且经统计学分 析认为 25. 6%的患者在 10年内会出现由于相邻节段退变而导致的临 床症状。 （Hilibrand AS, Carlson GD, Palumbo MA, et al. Radiculopathy and myelopathy at segments adjacent to the site of a p revious anterior cervical arthrodesis [J]. J Bone Joint Surg Am, 1999, 81(4)： 519 - 528. ) 生物力学实验的结果也证实了施行融合手术后相邻节段的椎间盘内 压力增高。动力位的影像学证据也显示融合术后相邻节段椎体的相对 活动度加大。这些因素都极有可能促进了融合术后临近节段的退行性 变。
针对融合术后所产生的施术节段活动度丧失以及临近节段的退 变等缺点， 国内外科学家和医生建立了脊柱非融合手术方式， 其理念 便是运动保留 （motion preservation )。 而人工椎间盘置换术 （又称椎 间盘成形术）便是施行非融合手术的典型代表。 目前临床上主要应用 的椎间盘有 Bryan假体， ProDisc— C假体， Prestige假体， PCM假体 等。 目前认为， 人工椎间盘置换术的最佳指征是单节段， 颈椎生理弯 曲存在 (Sekhon LH. Cervical arthroplasty in the management of spondylotic myelopathy [ J ]. J SpinalDisord Tech, 2003, 16 (4)： 307 - 313)。公认的禁忌征有骨质疏松和椎体间不稳 (Wiffield CC, Skrzyp iec D, Jackowski A, et al. Internal stress distribution in cervical intervertebral discs: the influence of an artificial cervical joint and simulated anterior interbody fusion[ J ].J Spinal Disord Tech, 2003, 16 (5)： 441- 449.)。虽然 各种人工椎间盘的材料、 形态各异， 但是它们存在的共同的缺点有： 一、 只能单独置换椎间盘， 而对合并椎体病变无能为力 （比如椎体肿 瘤， 以及需要对椎体进行减压的手术）。 二、 多数学者不认同多节段 的椎间盘置换术， 尤其是相邻的两个椎间盘同时进行置换术。
综上所述， 目前现有的技术不能解决颈椎手术后活动性的问题， 尤其是多个节段手术后不能活动的问题，以及由此带来的融合术后相 邻节段的退变问题。 因此， 本申请研制了以下同时具备人工椎体的支撑功能和人工 90 椎间盘的活动性能的长度可调节的人工颈椎椎体和椎间连接复合体。
发明内容
本发明的目的在于克服上述现有技术的缺点， 提供一种可调式 人工颈椎及椎间连接复合体，该连接复合体同时具备人工椎体的支撑 功能和人工椎间盘的活动性能、长度可调节， 能够实现颈椎前路手术 95 后的即刻稳定， 能起到支撑作用， 也可以实现颈椎前路术后即刻运动 功能重建， 使其活动性能与正常颈椎高度仿生。
本发明的目的是通过以下技术方案来解决的：
这种可调式人工颈椎及椎间连接复合体， 包括椎体部件以及分 别通过球关节结构连接于椎体部件上下端的两个终板部件；所述椎体 100 部件由上椎体部件和下椎体部件组成，所述上椎体部件和下椎体部件 轴向通过螺紋连接；在所述上椎体部件和下椎体部件的侧周壁上径向 对应设有若干螺孔，在上椎体部件和下椎体部件的螺孔间还设有一个 长度固定螺钉； 所述两个终板部件上分别设有终板部件固定螺钉。
上述球关节结构包括设置在终板部件上的关节球结构以及设置
105 在上椎体部件或下椎体部件端部与所述关节球结构相适应的臼口结 构，所述臼口结构的内部空间由处于中心的圆柱空间以及与圆柱空间 两侧相贯的半球空间组成； 且所述臼口结构的内部大、 出口小， 将关 节球结构包在其内。
上述终板部件包括圆板， 在圆板的内侧面边沿垂直固定关节球
110 结构，圆板的外侧面在远离所述关节球结构固定位置的边沿处通过相 邻的两个螺孔固定有两个所述终板部件固定螺钉；所述终板部件固定 螺钉的轴向与所述圆板平面成一定角度。
上述圆板的上表面为磨砂样粗糙结构， 并设有生物用羟基磷灰 石涂层。
上述羟基磷灰石涂层的厚度为 ΐ μ ηι, 圆板上表面的后半部分有 大小 1 μ m的小齿结构。
上述圆板的板厚度于固定终板部件固定螺钉的一侧薄、 于固定 关节球结构的一侧厚， 从圆板的侧面看形成一切面， 该切面约从终板 结构的正中线开始， 沿前下方向， 形成一个 10° 的切面， 该切面使 终板部件与相邻的上椎体形成 80° 的斜面，与相邻的下椎体形成 100 的斜面。
上述上椎体部件的下部缩颈设有外螺紋， 所述下椎体部件上端 为设有内螺紋的圆筒结构，所述上椎体部件的下部缩颈端通过螺紋旋 入下椎体部件的内螺紋内；在所述上椎体部件和下椎体部件的轴向均 匀分布有若干径向螺紋通孔，所述长度固定螺钉能够通过螺紋装入螺 紋通孔内以固定上椎体部件和下椎体部件在轴向上的相对位置。
以上整个复合体最小长度为 23mm， 最大长度为 29mm， 调节范 围为 6mm。
上述终板部件固定螺钉的前端为尖头， 所述固定螺钉的后端为 螺帽， 该固定螺钉的近螺帽端比其近尖头端略粗。
本发明的有益效果是：
本发明能够在颈椎前路手术后即刻发挥支撑作用， 并通过自带 的椎间连接部分替代正常颈椎的运动功能，能够有效的防止融合手术 后导致的相邻节段的退变。此外， 能够通过植骨和本复合体表面的羟 135 基磷灰石涂层实现生物学融合和长期稳定性。手术难度较小，创伤小， 便于推广。 由于本复合体本身长度的可调节性， 可以减小生产和携带 负担， 能够适合绝大多数的人群。
附图说明
图 1是本发明的整体结构示意图；
140 图 2是本发明的上椎体部件 2结构示意图；
图 3是图 2的俯视图；
图 4是本发明的下椎体部件 3结构示意图；
图 5是本发明的终板部件 1结构示意图图；
图 6是图 5的俯视图；
145 其中： 1为终板部件； 2为上椎体部件； 3为下椎体部件； 4为 终板部件固定螺钉； 5为长度固定螺钉； 6为关节球结构； 7为螺孔； 8为小齿结构； 9为圆板； 10为臼口结构。
具体实施方式
下面结合附图对本发明做进一歩详细描述：
150 参见图 1， 本发明的可调式人工颈椎及椎间连接复合体， 包括椎 体部件以及分别通过球关节结构连接于椎体部件上下端的两个终板 部件 1 ; 椎体部件由上椎体部件 2和下椎体部件 3组成， 其中上椎体 部件 2和下椎体部件 3轴向通过螺紋连接；在上椎体部件 2和下椎体 部件 3的侧周壁上径向对应设有若干螺孔，在上椎体部件 2和下椎体 155 部件 3的螺孔间还设有一个长度固定螺钉 5 ; 两个终板部件 1上分别 设有终板部件固定螺钉 4。 以下结合附图对组成本发明的各部件进行 详细描述：
参见图 1、 图 2、 图 4和图 5， 以上所述的球关节结构包括设置 在终板部件 1上的关节球结构 6以及设置在上椎体部件 2或下椎体部 160 件 3端部与关节球结构 6相适应的臼口结构 10， 该臼口结构 10的内 部空间由处于中心的圆柱空间以及与圆柱空间两侧相贯的半球空间 组成； 且臼口结构 10的内部大、 出口小， 将关节球结构 6包在其内。 关节球结构 6与臼口结构 10相互配合， 实现椎间连接四个自由度的 活动功能。
165 在本发明的最佳实施例中： 关节球结构 6由直径 4mm的圆球的
85%和与之匹配的圆柱状结构相连。该关节球结构 6分别与上椎体部 件和下椎体部件的臼口结构 10相吻合。上下的臼口结构 10在左右侧 面是与关节球结构 6完全吻合的 （即直径为 4mm)。 臼口结构 10是 由一个直径为 4mm的圆沿 X轴（即水平面上沿椎体前后缘中点的连
170 线）拉伸 1.5mm构成的。 立体的看， 相当于是一个直径为 4mm的半 球加一个底面直径为 4mm， 高为 1.5mm的圆柱形再加上一个直径为 4mm的半球三部分共同组成的窝柱结构的 85%。 这样的椎间连接有 如下优点： 1、 85%的匹配性可以形成超过一半的关节吻合性， 保证 该椎间连接的绝对稳定， 不会造成置入术后的关节脱位现象的发生；
175 2、 椎间连接活动的中心偏向椎体的中柱略靠后的位置， 符合正常脊 柱的运动轴心， 置入后对脊柱的生物力学性能影响不大； 3、 该椎间 连接可以实现 4个自由度的活动， （设定水平面上沿椎体前后缘中点 的连线为 X轴， 水平面上沿椎体左右缘中点的连线为 Y轴， 垂直方 向为 Z轴）， 分别是前屈和后伸约 15 ° (即沿 Y轴旋转）， 左右侧屈
180 约 15 ° (即沿 X轴旋转）， 左右旋转由于脊柱后柱的限制作用， 也能 保持在 15到 20° (即沿 Z轴旋转）， 前后平移约 1.5mm (即沿 X轴 平移）。 其中最重要的是该椎间连接能够实现目前几乎所有的人工椎 间盘和人工椎体都不能实现的前后平移的作用。多数文献证实， 人的 脊柱在能够进行前屈， 后伸， 左右侧屈， 左右旋转的功能的同时， 还
185 能够进行上下椎体间的前后平移，该前后平移对防止椎间盘及颈椎退 变有积极的作用。但是前后平移的距离不宜过大， 如果过大， 会造成 椎体失稳。 因此， 通过独特设计的窝柱结构而形成的椎间连接， 可以 使上下椎体间有约 1.5mm的前后平移作用。 能够最大限度的仿生人 体颈椎和抑制颈椎疾病的术后退变。
190 如图 5和图 6， 终板部件 1包括圆板 9， 在圆板 9的内侧面边沿 垂直固定关节球结构 6， 圆板 9的外侧面在远离所述关节球结构 6固 定位置的边沿处通过相邻的两个螺孔 7 固定有两个终板部件固定螺 钉 4; 终板部件固定螺钉 4的轴向与所述圆板 9平面成一定角度 （如 图 1所示）。 圆板 9的板厚度于固定终板部件固定螺钉 4的一侧薄、
195 于固定关节球结构 6的一侧厚。并且在圆板 9的外侧面上设置有小齿 在本发明的最佳实施例中：
终板部件 1 的圆板 9前半部分较后半部分薄， 从侧面看形成切 面， 角度约为 10° ， 该切面约从圆板 9的正中线开始， 沿前下方向，
200 形成一个约 10° 的切面。 该切面使终板部件 1 与相邻的上椎体形成 了 80° 的斜面， 与相邻的下椎体形成了 100° 的斜面。这两个斜面非 常有利于与施术椎体相邻的上下椎体的终板密切贴合。在圆板 9的前 半部分， 有两个螺孔 7， （螺孔位置参见图 6， 螺孔的方向是与相邻椎 体的前缘线呈 20° 的夹角）， 这两个螺孔带内螺紋， 与终板部件固定
205 螺钉 4相配合。本发明的终板部件固定螺钉 4的前端为尖头， 其后端 为螺帽 （如图 1所示）， 该终板部件固定螺钉 4的近螺帽端比其近尖 头端略粗。 终板部件固定螺钉 4可以与施术椎体相邻的椎体成 20° 的角度的方向置入相邻椎体。终板部件固定螺钉 4的近螺帽端与螺孔 7配合， 由于螺孔 7的内螺紋结构， 配合较长的终板部件固定螺钉 4，
210 可以将本复合体稳定的固定在施术椎体相邻的椎体上， 实现即刻稳 定， 发挥椎体的支撑作用。 同时， 这样的固定方式与前方螺钉固定相 比， 螺钉拧入的深度更长， 更符合生物力学特性。 另外， 本发明之所 以将终板部件固定螺钉 4的钉身设计为前端细，后端与螺孔 7配合的 一端略粗，是因为这种结构在将终板部件固定螺钉 4由螺孔 7穿入时，
215 可以方便的调节终板部件固定螺钉 4的角度， 等终板部件固定螺钉 4 攻入相邻的椎体内时， 其近螺帽端刚好与螺孔 7进行螺紋配合， 从而 将终板部件固定螺钉 4的角度锁定。
圆板 9 的上表面为磨砂样粗糙结构， 并有利用等离子体氧化技 术处理而形成的生物用羟基磷灰石涂层， 涂层厚度约 ΐ μ ηι, 上表面
220 的后半部分有大小约 1 μ m的小齿结构 8。 所有的上表面处理， 都可 以加速终板结构与相邻椎体的早期融合，有利于实现生物融合和长期 稳定性。
参见图 1或者图 2和图 4，上椎体部件 2的下部缩颈并设有外螺 紋， 下椎体部件 3上端为设有内螺紋的圆筒结构， 上椎体部件 2的下
225 部缩颈端通过螺紋旋入下椎体部件 3的内螺紋内；在上椎体部件 2和 下椎体部件 3 的轴向均匀分布有若干径向螺紋孔 11和 12 (图 2、 3 中给出具有 3个径向螺紋孔 11、 12的情况）， 长度固定螺钉 5能够通 过螺紋装入螺紋孔内以固定上椎体部件 2和下椎体部件 3在轴向上的 相对位置。
230 在本发明的最佳实施例中：
下椎体部件 3由上部（直径约 12mm，高约 lOmm,壁厚约 2mm) 的空心圆柱结构和下部（直径约 12mm， 高约 4mm)的实心圆柱部分 组成 （参见图 4)。 上部的空心圆柱结构的正前方有一个直径为 2mm 的固定孔， 带内螺紋。 左右侧面各有四个连续的融合螺孔， 直径为
235 2mm, 不带螺紋。下椎体部件 3的外表面覆有经过等离子体氧化技术 处理的厚度约为 l m的生物用羟基磷灰石涂层。 下部正中有前述的 臼口结构 10， 下部的虚线显示了臼口结构 10 的位置， 臼口结构 10 与下位终板部件 1的关节球结构 6相匹配。
上椎体部件 2的下部的外螺紋可与下椎体部件 3的上部的内螺
240 紋相吻合。 由于螺距是 lmm， 所以每外旋转一圈可以使整个复合体 的长度增加 lmm。 上椎体部件 2的下部左右两侧各有四个融合螺孔 12， 下椎体部件 3 的上部左右两侧也各有四个融合螺孔 15， 融合螺 孔的直径均为 2mm， 不带螺紋。 每旋转两圈， 上椎体部件 2的融合 螺孔 （即螺孔 12 ) 就会与一部分下椎体部件 3 的融合螺孔 （即螺孔
245 11 )相通。 在长期植入后， 上椎体部件 2的下部空心圆柱结构内填充 的碎骨可以沿着融合螺孔长出，实现稳定的椎体部件与施术椎体的稳 定融合。此外， 可靠上椎体部件和下椎体部件外表面的羟基磷灰石涂 层，可以加速术后的融合过程，实现生物学融合，保证了长期稳定性。
上椎体部件 2下部正前方的四个调节螺孔 11和下椎体部件 3上 250 部正前方的一个固定螺孔均带内螺紋， 与椎体长度固定螺钉 5 相匹 配。 由于调节螺孔和固定螺孔的直径均为 2mm， 因此每旋转两圈， 下椎体部件 3的正前方的固定螺孔就会和上椎体部件 2的正前方的调 节螺孔相吻合， 此时， 可用椎体长度固定螺钉 5沿固定螺孔和调节螺 孔拧入，依靠上椎体部件 2的下部的外螺紋与下椎体部件 3的上部的
255 内螺紋的吻合性和螺钉 5与固定螺孔及调节螺孔的把持力，实现复合 体长度的固定。 四个调节螺孔可以保证使整个复合体的长度调节
6mm, 完全满足正常人颈椎的长度需要。
以上上椎体部件 2和下椎体部件 3两者相互配合， 通过旋转可 以调节整个复合体的长度（整个复合体最小长度为 23mm， 最大长度 260 为 29mm。 调节范围为 6mm)。
综上所述， 本发明的可调式颈椎人工椎体及椎间连接复合体尤 其适合于处理相邻两个颈椎间盘突出导致的颈椎病，可以行椎间盘摘 除、 椎体次全切除、 本复合体置换术。 同时， 对于颈椎单椎体肿瘤可 以行患椎次全切并本复合体置换术。此外， 对于不适用于人工颈椎间 265 盘置换的患者， 人工颈椎间盘置换术后翻修， 颈椎融合术后退变严重 等多种颈椎疾病都可以使用本复合体。 以下就椎间盘摘除、椎体次全 切除并本复合体置换术来说明手术中的具体实施方式对于具备适应 症， 术前检查未见禁忌症的患者进行该手术治疗， 常规术前准备， 通 常选择气管内插管全麻。 体位为仰卧位， 双肩垫软枕， 头自然向后仰
270 伸， 后枕部垫软头圈预防压疮， 头两侧各放置小沙袋以防止术中头旋 转。 切口一般采用颈前横切口， 暴露患椎和椎间盘， 定位针并术中 C 形臂 X线光透视机定位。 于拟行次全切除的椎体的上下位椎体中央 分别拧入颈椎椎体撑开器螺钉， 在撑开螺钉上套入撑开器， 向上下两 端撑开。 减压： 用尖刀切开施术椎体上下方的椎间盘的纤维环， 髓核
275 钳取出椎间盘组织，用三关节尖嘴咬骨钳咬除椎体的前皮质骨和大部 分的松质骨， 接近椎体后缘时暂停， 完全切除施术椎体上下方的椎间 盘， 用刮匙、 咬骨钳和圆头锉修复椎间关节面至软骨下出血， 使终板 大致平行， 不可破坏骨性终板。用神经剥离器分离出椎体后缘与后纵 韧带间的间隙， 用枪式咬骨钳逐歩咬除椎体后缘皮质骨， 形成一个长
280 方形的减压槽 （有时可根据需要咬除后纵韧带）， 减压槽的宽度大致
12mm。 调节椎体撑开器撑开的高度， 使颈椎前柱的高度恢复正常。 此时， 将次全切下的椎体骨质减成 2mm左右的碎骨， 填充在本复合 体上椎体部件下部的圆柱形空心结构内。置入本复合体， 按照所需高 度调节本复合体的长度， 使上终板部件与上位椎体的下终板相贴合， 285 下终板部件与下位椎体的上终板相贴合。根据这个长度， 拧入椎体长 度固定螺钉 5， 固定本复合体长度。 将本复合体的上下椎体部件击入 减压槽。 根据终板部件上的固定螺孔 7， 分别在上下位椎体的下上终 板上开口， 再将终板固定螺钉 4按与上下位椎体前缘成 20° 角拧入 上下位椎体。松开椎体撑开器， 使本复合体嵌紧。 C形臂 X线光机透 视无误后， 冲洗伤口， 防止引流， 逐层缝合。 术后颈托制动 40天， 预防性使用抗生素， 密切观察， 其他按颈前路手术常规处理。

Claims

1.一种可调式人工颈椎及椎间连接复合体， 其特征在于， 包括椎体部件以 及分别通过球关节结构连接于椎体部件上下端的两个终板部件 （1); 所述椎体 部件由上椎体部件 （2) 和下椎体部件 （3) 组成， 所述上椎体部件 （2) 和下椎 体部件 （3) 轴向通过螺紋连接； 在所述上椎体部件 （2) 和下椎体部件 （3) 的 侧周壁上径向对应设有若干螺孔， 在上椎体部件 （2) 和下椎体部件 （3) 的螺 孔间还设有一个长度固定螺钉 （5); 所述两个终板部件 （1) 上分别设有终板部 件固定螺钉 （4)。
2.根据权利要求 1所述的可调式人工颈椎及椎间连接复合体， 其特征在于， 所述球关节结构包括设置在终板部件 （1) 上的关节球结构 （6) 以及设置在上 椎体部件 （2) 或下椎体部件 （3) 端部与所述关节球结构 （6) 相适应的臼口结 构 （10)， 所述臼口结构 （10) 的内部空间由处于中心的圆柱空间以及与圆柱空 间两侧相贯的半球空间组成； 且所述臼口结构 （10) 的内部大、 出口小， 将关 节球结构 （6) 包在其内。
3.根据权利要求 2所述的可调式人工颈椎及椎间连接复合体， 其特征在于， 所述终板部件 （1) 包括圆板 （9)， 在圆板 （9) 的内侧面边沿垂直固定关节球 结构 （6)， 圆板 （9) 的外侧面在远离所述关节球结构 （6) 固定位置的边沿处 通过相邻的两个螺孔固定有两个所述终板部件固定螺钉 （4); 所述终板部件固 定螺钉 （4) 的轴向与所述圆板 （9) 平面成一定角度。
4.根据权利要求 3所述的可调式人工颈椎及椎间连接复合体， 其特征在于， 所述圆板 （9) 的上表面为磨砂样粗糙结构， 并设有生物用羟基磷灰石涂层。
5.根据权利要求 4所述的可调式人工颈椎及椎间连接复合体， 其特征在于， 所述羟基磷灰石涂层的厚度为 20μηι， 圆板 （9) 上表面的后半部分有大小 20 μηι的小齿结构 （8)。
6.根据权利要求 3、 4或 5所述的可调式人工颈椎及椎间连接复合体， 其特 征在于， 所述圆板 （9) 的板厚度于固定终板部件固定螺钉 （4) 的一侧薄、 于 固定关节球结构 （6) 的一侧厚， 从圆板 （9) 的侧面看形成一切面， 该切面约 从终板结构（9) 的正中线开始， 沿前下方向， 形成一个 10° 的切面， 该切面使 终板部件 （1) 与相邻的上椎体形成 80° 的斜面， 与相邻的下椎体形成 100° 的 斜面。
7.根据权利要求 1所述的可调式人工颈椎及椎间连接复合体， 其特征在于， 所述上椎体部件 （2) 的下部缩颈设有外螺紋， 所述下椎体部件 （3) 上端为设 有内螺紋的圆筒结构， 所述上椎体部件 （2) 的下部缩颈端通过螺紋旋入下椎体 部件 （3) 的内螺紋内； 在所述上椎体部件 （2) 和下椎体部件 （3) 的轴向均匀 分布有若干径向螺紋通孔， 所述长度固定螺钉 （5) 能够通过螺紋装入螺紋通孔 内以固定上椎体部件 （2) 和下椎体部件 （3) 在轴向上的相对位置。
8.根据权利要求 1或 7所述的可调式人工颈椎及椎间连接复合体， 其特征 在于， 整个复合体最小长度为 23mm， 最大长度为 29mm， 调节范围为 6mm。
9.根据权利要求 1或 Ί所述的可调式人工颈椎及椎间连接复合体， 其特征 在于， 所述下椎体部件（3) 的外表面覆有经过等离子体氧化技术处理的厚度为 20 μ m的生物用羟基磷灰石涂层。
10. 根据权利要求 1所述的可调式人工颈椎及椎间连接复合体， 其特征在 于， 所述终板部件固定螺钉 （4) 的前端为尖头， 所述终板部件固定螺钉 （4) 的后端为螺帽， 该终板部件固定螺钉 （4) 的近螺帽端比其近尖头端略粗。
PCT/CN2011/076587 2011-06-29 2011-06-29 一种可调式人工颈椎及椎间连接复合体 WO2013000138A1 (zh)

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