WO2010139231A1 - 人工椎间盘 - Google Patents

人工椎间盘 Download PDF

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Publication number
WO2010139231A1
WO2010139231A1 PCT/CN2010/072787 CN2010072787W WO2010139231A1 WO 2010139231 A1 WO2010139231 A1 WO 2010139231A1 CN 2010072787 W CN2010072787 W CN 2010072787W WO 2010139231 A1 WO2010139231 A1 WO 2010139231A1
Authority
WO
WIPO (PCT)
Prior art keywords
joint
intervertebral disc
artificial intervertebral
pin
annular body
Prior art date
Application number
PCT/CN2010/072787
Other languages
English (en)
French (fr)
Inventor
郑诚功
柴鹏
赵富强
刘建祥
Original Assignee
北京纳通投资有限公司
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 北京纳通投资有限公司 filed Critical 北京纳通投资有限公司
Priority to US13/376,108 priority Critical patent/US8974529B2/en
Priority to JP2012513456A priority patent/JP5357330B2/ja
Priority to EP10782935.0A priority patent/EP2438890A4/en
Publication of WO2010139231A1 publication Critical patent/WO2010139231A1/zh

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442Intervertebral or spinal discs, e.g. resilient
    • A61F2/4425Intervertebral or spinal discs, e.g. resilient made of articulated components
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006Properties of materials and coating materials
    • A61F2002/30062(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006Properties of materials and coating materials
    • A61F2002/30079Properties of materials and coating materials magnetic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108Shapes
    • A61F2002/30199Three-dimensional shapes
    • A61F2002/302Three-dimensional shapes toroidal, e.g. rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30476Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
    • A61F2002/305Snap connection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30476Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
    • A61F2002/30505Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism spring biased
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30565Special structural features of bone or joint prostheses not otherwise provided for having spring elements
    • A61F2002/30566Helical springs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30604Special structural features of bone or joint prostheses not otherwise provided for modular
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30604Special structural features of bone or joint prostheses not otherwise provided for modular
    • A61F2002/30607Kits of prosthetic parts to be assembled in various combinations for forming different prostheses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30621Features concerning the anatomical functioning or articulation of the prosthetic joint
    • A61F2002/30647Joints made of two toroidal rings engaged together
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30621Features concerning the anatomical functioning or articulation of the prosthetic joint
    • A61F2002/30649Ball-and-socket joints
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30621Features concerning the anatomical functioning or articulation of the prosthetic joint
    • A61F2002/30649Ball-and-socket joints
    • A61F2002/30662Ball-and-socket joints with rotation-limiting means
    • AHUMAN NECESSITIES
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30841Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0065Three-dimensional shapes toroidal, e.g. ring-shaped, doughnut-shaped
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/49Method of mechanical manufacture
    • Y10T29/49826Assembling or joining

Definitions

  • the invention belongs to the technical field of prosthesis implanted in the human body, and particularly relates to a spinal joint prosthesis. Background technique
  • Artificial disc replacement surgery is an effective method for the treatment of degenerative disc disease, and it is increasingly replacing the currently used spinal fusion surgery. It has many advantages such as restoring the height of the intervertebral space, reducing the stress concentration of adjacent segments, maintaining the joint mobility between the intervertebral bodies, and preventing the degradation of the facet joints. It uses a movable artificial intervertebral disc as an implant to replace the active function of the original natural disc.
  • the common artificial intervertebral disc structure mainly includes upper and lower joints respectively fixedly connected with adjacent segments (adjacent vertebral endplate bones), and a ball and socket structure is arranged between the upper and lower joints.
  • These artificial intervertebral discs are active immediately after implantation into the intervertebral space, thereby ensuring the realization of the aforementioned advantages.
  • the initial fixation between the upper and lower joints of the artificial intervertebral disc and the adjacent segments relies on mechanical fixation
  • the final fixation requires a certain amount of time to stabilize the bones of the upper and lower joints and the adjacent vertebral endplates.
  • Combination hereinafter referred to as biological fixation).
  • the present invention provides an artificial intervertebral disc mounting method and an artificial intervertebral disc.
  • the main idea of the present invention is to limit the movement of the artificial intervertebral disc at least to the upper and lower joints during the period before the bone grows into the contact surface by a temporary fixed connection, and to strengthen the upper and lower joints and the adjacent vertebral endplates.
  • the stability between the bones solves the above problems existing in the prior art.
  • the method for installing the artificial intervertebral disc comprises the following steps: fixing the matched upper and lower joints of the artificial intervertebral disc to the lower bone of the vertebral endplate according to the relationship between the upper and lower positions; Also included is a step of establishing a fixed connection relationship between the upper joint and the lower joint;
  • the fixed connection relationship at least limits one of the following movements: movement of the upper or lower joint relative to the lower or upper joint, the direction of movement being perpendicular to the axis of the artificial intervertebral disc replacement segmental intervertebral space; upper joint and/or The rotation of the lower joint about its own axis of rotation, the axis of rotation being a line that runs parallel to or coincides with the axis of the artificial intervertebral disc replacement segmental intervertebral space.
  • the artificial intervertebral disc includes an upper joint and a lower joint which are matched in accordance with the relationship between the upper and lower positions, and a removable fixed joint structure for fixing the upper joint and the lower joint.
  • the removable fixed connection structure fixes at least one of the following movements after the upper joint and the lower joint are fixedly connected: the movement of the upper joint or the lower joint relative to the lower joint or the upper joint, and the moving direction is the replacement of the intervertebral space with the artificial intervertebral disc
  • a more specific artificial intervertebral disc solution the upper joint and the lower joint are matched by a ball and socket structure, the removable fixed joint structure comprising the following structural elements: an annular body disposed between the upper joint and the lower joint,
  • the annular body is an inflatable structure.
  • the ball and socket structure is arranged in the inner ring of the annular body, and the upper end of the annular body bears against the upper joint and the lower end bears against the lower joint; the annular body and the upper and lower sides Friction between the joints limits the movement; removing the gas or liquid in the annulus removes the restriction on the movement.
  • the upper and lower joints are mated by a ball and socket structure, the retractable fixed connection structure comprising the following structural elements: an annular body disposed between the upper and lower joints, a ring
  • the ball and socket structure is disposed in the inner ring of the body, and the annular body can move along the axial direction of the intervertebral space of the artificial intervertebral disc; when the annular body bears against the upper joint, a frictional force is formed between the annular body and the upper joint, When the removable support body is provided on the lower joint, the movement is limited; when the support is removed, the restriction on the movement is removed.
  • the end face of the annular body and the upper joint is adapted to the end face of the corresponding end of the upper joint.
  • the retractable support body is a pin provided with a spring, and the spring is clamped by the pin and the lower joint.
  • the expansion and contraction direction of the spring is parallel to the axis of the pin.
  • the pin When the spring is in the extended state, the pin extends away from the lower joint body to support the annular body.
  • the annular body is provided with a groove adapted to the contact portion of the pin; when the spring is compressed to a certain extent, the pin is retracted in the direction of the lower joint body, and the support for the annular body is removed.
  • the material of the pin is a magnetic material.
  • the removable support body is a support member for fixing the support annular body, and the support member is made of a degradable material.
  • the artificial intervertebral disc of the present invention adds a temporary upper and lower joint fixed connection structure to the existing artificial intervertebral disc structure, and achieves the purpose of fixing the upper and lower joints in the bone growth stage, and when the conditions are appropriate ( After the upper and lower joints are biofixed with the bones of the adjacent vertebral endplates, the fixed connection structure can be undone, so that the upper and lower joints can move relative to each other, so that the artificial intervertebral disc can restore its proper function.
  • Fig. 1 is a view showing the positional relationship of various components of the artificial intervertebral disc of the present invention.
  • Figure 2 is a cross-sectional view of the assembled artificial intervertebral disc.
  • Figure 3 is an illustration of a pin in an artificial intervertebral disc of the present invention.
  • Figure 4 is another example of a pin in an artificial intervertebral disc of the present invention.
  • Figure 5 is a third example of a pin in an artificial intervertebral disc of the present invention.
  • Figure 6 is a fourth example of a pin in an artificial intervertebral disc of the present invention.
  • the logo in the figure is as follows:
  • the upper and lower joints of the artificial intervertebral disc are installed according to the predetermined positional relationship (refer to the positional relationship between the upper joint and the lower joint shown in Fig. 1), that is, the upper joint and the lower joint are respectively fixed to the adjacent vertebral body of the artificial intervertebral disc by the protrusion 2
  • the endplate is under the bone. Because the bones of the adjacent vertebral endplates will form pressure on the joints and lower joints from the upper and lower directions, this It is advantageous to have a strong bond between the artificial intervertebral disc and the base bone, especially when the bone has not yet grown into the joint surface (ie, before biofouling is formed).
  • the binding state of the upper joint and the lower joint to the bone of the adjacent vertebral endplate is detected. If the upper joint and the lower joint are both biologically fixed with the fixed vertebral endplate bone, the non-invasive Surgical or minimally invasive methods disconnect the above fixed connection and restore all active functions of the artificial intervertebral disc.
  • the artificial intervertebral disc mounting method of the present invention solves the problem that the prior art artificial intervertebral disc is delayed and uncoupled from the adjacent segment after being implanted into the human body.
  • the upper or lower joints are opposite to the lower ones. Movement of the joint or upper joint, the direction of movement is perpendicular to the axis of the intervertebral space of the artificial disc replacement; the rotation of the upper joint and/or the lower joint about its own axis of rotation, the axis of rotation is the replacement of the segmental vertebra with the artificial disc
  • the axis of the gap is parallel or coincident with a straight line that passes through the joint.
  • the above movement is explained as follows.
  • the movement of the upper joint or the lower joint relative to the lower joint or the upper joint refers to the relative movement between the upper joint and the lower joint, especially in the axis of the intervertebral space with the artificial intervertebral disc (the intervertebral space)
  • the intervertebral space where the segment replaced by the artificial intervertebral disc
  • the human spine has four curvatures (neck curvature, chest curvature, waist curvature, and distortion).
  • the direction of movement of the above-mentioned moving component is based on the axis (approximate straight line) of the intervertebral space where the artificial intervertebral disc is located.
  • a movement of the upper or lower joint relative to the lower joint or the upper joint can be broken down into sub-movements (moving components) on two planes intersecting in space, if one of the intersecting planes is set to be artificial
  • the intervertebral disc replaces the plane perpendicular to the axis of the intervertebral space and the movement of the superior or inferior joint has a moving component in the plane, then the movement has a biological fixation of the upper and lower joints and the vertebral endplate. Serious harm.
  • the following rotation also has serious damage to the upper and lower joints and the vertebral endplate bone formation: the rotation of the upper joint and/or the lower joint about its own axis of rotation, and the axis of rotation is the replacement segment with the artificial disc
  • the axis of the intervertebral space is parallel or coincident with a straight line passing through the joint, and the axis referred to herein is the same as the axis referenced by the upper segment.
  • the artificial intervertebral disc mounting method of the present invention has at least a fixed connection relationship between the joint and the lower joint.
  • One of the above-mentioned sports that pose a serious hazard to the formation of biological fixation should be limited.
  • Figure 1 discloses an embodiment of an artificial intervertebral disc of the present invention.
  • the artificial intervertebral disc of the present invention comprises an upper joint 3 and a lower joint 7 which are matched according to an upper and lower positional relationship.
  • the upper joint 3 and the lower joint 7 are matched by a ball and socket structure, and the ball and socket structure is a common movable joint structure, passing the ball.
  • the joint 3 and the lower joint 7 can be relatively rotated on the socket structure to realize the active function of the natural intervertebral disc.
  • the ball and socket structure includes at least two elements of the ball head 4 and the ball and socket corresponding to the ball head 4.
  • the surface of the ball head 4 can slide relative to the surface of the ball socket to form an effect of the ball head 4 rotating relative to the ball socket.
  • the head 4 is not limited to a standard sphere, and may be an ellipsoid or the like.
  • the ball and socket structure according to the present invention may be a combination of a ball head 4 fixedly disposed on the upper joint or the lower joint and a ball socket corresponding to the lower joint or the upper joint, or a ball socket provided on the upper joint and the lower joint. A separate sphere is placed between the two ball sockets as the ball head 4.
  • a removable fixed connection structure is arranged between the upper and lower joints, and the fixed connection structure can maintain the positional relationship of the upper and lower joints fixed, that is, no relative movement between the upper joint and the lower joint, and the fixed joint structure Can be removed or revoked, so that the fixed connection between the upper and lower joints is removed. Since some relative motion between the upper and lower joints has different degrees of adverse effects on the formation of biological fixation, the removable fixed connection structure can temporarily limit these relative movements between the upper and lower joints. It is beneficial to achieve the object of the present invention. Of course, the embodiment shown in Figure 1 is directed to limiting the number of motions that have the most adverse effects on achieving biofixation, and is more advantageous for achieving the objectives of the present invention.
  • the movements are: movement of the upper joint 3 or the lower joint 7 relative to the lower joint 7 or the upper joint 3, the direction of movement being perpendicular to the axis of the intervertebral space in which the artificial intervertebral disc is replaced; the upper joint 3 and/or The lower joint rotates about its own axis of rotation, and the axis of rotation is a line that runs parallel to or coincides with the axis of the intervertebral disc space of the artificial disc replacement segment.
  • the so-called removable fixed connection structure enables the artificial intervertebral disc to implement the method of the present invention, that is, to limit the above-mentioned several movements between the upper joint 3 and the lower joint 7 for a certain period of time, and then can be disconnected by removing the fixed joint structure.
  • the removable fixed connection structure in the embodiment shown in Fig. 1 includes the following elements: a ball and socket structure that cooperates the upper joint 3 and the lower joint , the ball and socket structure includes a ball head 4 disposed on the upper joint and a lower joint The corresponding ball nest. Also included is an annular body 5 disposed between the upper joint 3 and the lower joint, the ball and socket structure being disposed within the inner ring of the annular body 5, the annular body 5 being movable along the axial direction of the intervertebral space replaced by the artificial intervertebral disc That is, the annular body 5 covers the ball and socket structure and can move within a certain range (vertical direction in Fig. 1).
  • a plurality of pins supporting the annular body 5 are evenly distributed on the lower joint 7 corresponding to the annular body 5, and the pins extend into the pin holes 8.
  • the two pin holes 8 visible in Fig. 1 are actually two ends of the pin holes penetrating the lower joint.
  • Two pins are provided in Fig. 1 to form a stable support for the annular body 5, which are respectively located at the front and rear positions of the lower joint in Fig. 1.
  • a portion exposed outside the pin hole 8 is in contact with the annular body 5, and is ring-shaped
  • the body 5 is supported, and the groove 6 is provided correspondingly at the portion where the ring body 5 contacts the pin, so that the pin not only supports the ring body 5 but also restricts the rotation of the ring body 5.
  • the position of the pin is such that the annular body 5 is simultaneously clamped by the pin and the upper joint body (the flange of the upper joint is clamped in Fig. 1), and the roughness of the contact surface of the annular body 5 with the upper joint 3 is increased, such that the ring A large frictional force can be generated between the body 5 and the upper joint 3, and this frictional force can restrict the movement of the upper joint 3 or the lower joint sac with respect to the lower joint 7 or the upper joint 3, specifically, the upper joint 3
  • the movement of the moving component is present in the direction perpendicular to the axis of the segmental intervertebral space (ie, in any direction parallel to the plane of the bonding surface 1) of the artificial intervertebral disc formed by the lower jaw.
  • the upper joint 3 is also restricted by the annular body 5 from being able to rotate around its own axis (the axis of rotation is parallel or coincident with the axis of the artificial intervertebral disc replacement segmental intervertebral space).
  • the straight line rotates, and there is a fixed connection relationship between the lower joint 7 and the upper joint 3, so the lower joint 7 is also unable to rotate around its own axis (the axis of rotation is parallel or coincident with the axis of the artificial intervertebral disc replacement segmental intervertebral space) a straight line that runs through the joint).
  • the annular body 5 adopts an inflatable structure, and the so-called inflatable structure means that the annular body is a closed hollow structure, when the annular body is filled with gas
  • the annular body has a structure as shown in Fig. 1.
  • the gas and liquid in the annular body are released, the annular body is atrophied and does not have the structure as shown in Fig. 1, similar to a balloon.
  • the volume is much smaller than when the gas or liquid is filled.
  • the annular body when the annular body is filled with gas or liquid, the upper end of the annular body bears against the upper joint, and the lower end bears against the lower joint (the flanges of the upper joint and the lower joint respectively), and the annular body is connected to the upper and lower sides.
  • the contact interfaces of the joints are all set to have a surface with a certain roughness, so that the contact interface between the annular body and the upper and lower joints has a frictional force, which limits the rotation of the annular body around the rotation axis of itself, and also limits the rotation of the ring body. Relative rotation between the upper and lower joints.
  • the gas or liquid in the ring body can be released, and the above-mentioned motion limitation is removed, so that the artificial Intervertebral disc recovery should be Sports function.
  • the radial dimension of the annular body 5 is not uniform, that is, the wall of the ring on the right side is thicker.
  • this sectional view reveals such a technical feature:
  • the end surface of the annular body 5 and the upper joint 3 ie, the end surface of the upper end of the annular body 5
  • the end surface corresponding to the upper joint 3 should be as close as possible (ie, The shape of the face of the flange portion of the upper joint 3 is similar to the area (i.e., the two end faces are adapted), achieving the largest possible support area for the upper joint 3.
  • the pin of Fig. 1 needs to have the following functions: Supporting the annular body 5;
  • the pin hole 8 can be removed or retracted to remove the support for the annular body 5.
  • the following examples are designed around this goal.
  • the cylindrical pin 9 is divided into two sections. The radial dimensions of the two sections are different.
  • the pin hole is a two-stage stepped hole.
  • the two coaxial holes of different inner diameters form a pin hole.
  • the aperture of the aperture is slightly larger than the radial dimension of the pin 9 and smaller than the radial dimension of the pin 9.
  • the pin 9 has a small radial dimension and is sheathed with a coil spring whose axis is parallel or coincident with the axis of the pin 9.
  • the axial extent of the spring in the naturally extended state is longer than the axial length of the section of the pin 9 which is smaller in radial dimension, and one end of the spring is placed at the junction (shoulder) between the two sections of the pin 9.
  • the pin 9 provided with the spring extends from the end of the pin hole having a large radial dimension into the pin hole, and the other end of the spring is placed at the junction of the two segments of the stepped hole having different radial dimensions.
  • the force directed to the left side of Fig. 3 may be achieved by an external force (e.g., minimally invasive surgery) push pin 9, or a magnetic material may be used to prepare the pin 9, and when necessary, a magnetic force is applied to the pin 9 on the left side of Fig. 3, pin 9
  • an external force e.g., minimally invasive surgery
  • a magnetic material may be used to prepare the pin 9, and when necessary, a magnetic force is applied to the pin 9 on the left side of Fig. 3, pin 9
  • pin 9 After retracting into the pin hole, after the magnetic force disappears, since the ring body has fallen, whether the pin 9 re-examines the pin hole does not affect the movement of the upper joint and the lower joint.
  • the advantage of the solution using the magnetic material is that it is only necessary to set the magnet at a proper position outside the human body when the pin 9 is retracted, and it is not necessary to open the wound on the human body, thereby reducing the suffering of the patient.
  • Fig. 4 shows another structure of the pin.
  • the pin 9 is divided into three sections in the axial direction.
  • the radial dimension of the three sections is different, and the radial dimension from left to right is sequentially large, small, and medium in size.
  • the pin hole in Fig. 4 is also a two-stage stepped hole.
  • the large diameter of the stepped hole is similar to the large radial dimension of the pin 9, and the small hole diameter of the stepped hole is similar to the radial dimension of the pin 9.
  • a flange is also provided in the hole of the small hole of the stepped hole, as shown in FIG.
  • the arrangement of the pin 9 in the pin hole is as follows:
  • the pin 9 has a large radial dimension section disposed in the large aperture section of the stepped bore (left side in Fig.
  • the radial dimension section of the pin 9 is disposed in the stepped bore small aperture section And all located on the right side of the flange, the radial aperture at the location of the flange: a small radial dimension of the pin 9 and less than the radial dimension of the pin 9.
  • Both ends of the coil spring 12 are respectively placed on the right side of the flange and at the junction of the radial dimension section and the small radial dimension section in the pin 9.
  • a fastening ring 10 is also embedded in the wall of the hole from the flange to the stepped hole of the large radial size section of the pin 9.
  • the spring 11 is respectively placed on the left side of the flange and the fastening ring 10, and the fastening ring 10 is assembled.
  • the working process of the pin shown in Figure 4 is as follows: The spring 11 between the fastening ring 10 and the flange is in a compressed state, the spring 12 push pin 9 extends out of the pin hole and the small radial end supports the annular body; When retreating to the left side, heating and melting the fastening ring 10 by heating means such as electromagnetic field heating, so that the spring 11 is extended, and the large radial size section of the spring 11 push pin 9 is moved to the left, when the force of the spring 11 is greater than the pressure When the force of the spring 12 is contracted, the pin 9 is moved to the left, and the support of the pin 9 to the annular body is removed.
  • This method of removing the support only needs to perform electromagnetic field heating outside the human body, without causing wounds on the human body and reducing the suffering of the patient.
  • the pin hole is a blind hole
  • an elastic member is disposed between the left end of the pin corresponding to the pin hole diameter and the bottom of the pin hole, thereby realizing the movement of the pin 9 in the left and right directions, That is, the pin 9 supports and removes the supporting function of the annular body.
  • the resilient member can be controlled by a remote control circuit, which is implemented by external remote control when the pin 9 is retracted (i.e., moved to the left in Figure 5).
  • the pin shown in Fig. 6 has no complicated mechanical structure, but a pin 9 which cannot be moved in the pin hole.
  • the pin 9 is made of a degradable material, and the so-called degradable material refers to a material which can be gradually degraded in the human body environment. , such as synthetic polymer material polylactide (polylactic acid). This degradation process takes a certain amount of time. When the pin 9 degrades to a certain extent, the support of the ring body is removed when the pin 9 cannot support the ring body.
  • the pin 9 also has the ability to support the annular body during the degradation process, so that the degradation process can be designed to be comparable to the time at which the bone grows on the joint surfaces of the upper and lower joints, achieving the object of the present invention.
  • the control of the degradation process time is achieved by the choice of degradable material and/or the choice of pin 9 geometry.

Description

人工椎间盘 技术领域
本发明属于植入人体的假体技术领域, 特别涉及一种脊柱关节假体。 背景技术
人工椎间盘置换手术是治疗退行性椎间盘疾病的一种有效方法, 它正在日益取代目前 常用的脊柱融合手术。 它具有恢复椎间隙高度、 减小相邻节段应力集中、 保持椎体间关节 活动度、 防止小关节突关节退化等诸多优点。 它采用的是可活动的人工椎间盘作为植入物 来代替原有天然椎间盘的活动功能。
常见的人工椎间盘结构主要包括分别与相邻节段 (相邻的椎体终板下骨) 固定连接的 上、 下关节, 上、 下关节之间设置有球窝结构。 这些人工椎间盘植入椎间隙后立即具有活 动性, 从而保证前述的诸多优点的实现。 但是, 由于人工椎间盘的上、 下关节和相邻节段 之间最初的固定依靠的是机械固定, 最终的固定需要一定的时间来实现上、 下关节与相邻 椎体终板下骨的稳定结合(以下称为生物固定)。 即通过在人工椎间盘的突起嵌入椎体实现 机械固定和在人工椎体进行表面处理技术来实现的, 让骨质长入人工椎间盘的接触表面从 而形成上述生物固定。 在骨质长入人工椎间盘接触表面之前的时间段里, 由于人工椎间盘 的上关节与下关节之间的相对运动导致上、 下关节与相邻椎体终板下骨结合面之间产生不 稳定性, 会延迟上、 下关节与相邻椎体终板下骨的结合, 甚至导致不结合。 所以在目前上 市的人工椎间盘的临床报告中常有人工椎间盘移位、 甚至脱位的发生, 人工椎间盘的下沉 也与之有关。 发明内容
为了解决现有的人工椎间盘植入人体后存在的与相邻椎体终板下骨结合延迟和不结合 的问题, 本发明提供了一种人工椎间盘安装方法和人工椎间盘。
本发明的主要思想是通过临时性的固定连接使得人工椎间盘在骨质长入接触表面之前 的时间段里至少限制上、 下关节的部分运动, 增强上、 下关节与相邻椎体终板下骨之间的 稳定性以解决现有技术存在的上述问题。
本发明的技术方案如下:
人工椎间盘安装方法, 包括如下步骤: 将人工椎间盘的相配合的上关节和下关节按照 上、 下位置关系分别固定设置于椎体终板下骨上; 还包括在上关节和下关节之间建立固定连接关系的步骤;
及在上关节与下关节均与所述椎体终板下骨实现生物固定后, 断开所述上关节和下关 节之间固定连接关系的步骤。
所述固定连接关系至少限制如下运动之一: 上关节或下关节相对于下关节或上关节的 移动, 移动方向为与该人工椎间盘置换节段椎间隙的轴线垂直的方向; 上关节和 /或下关节 绕自身旋转轴线的转动, 旋转轴线为与该人工椎间盘置换节段椎间隙的轴线平行或重合的 贯通该关节的直线。
人工椎间盘, 包括按照上、 下位置关系相配合的上关节和下关节, 还包括一个固定连 接上关节与下关节的可撤除式固定连接结构。
所述可撤除式固定连接结构固定连接上关节和下关节后至少限制如下运动之一: 上关 节或下关节相对于下关节或上关节的移动, 移动方向为与该人工椎间盘置换节段椎间隙的 轴线垂直的方向; 上关节和 /或下关节绕自身旋转轴线的转动, 旋转轴线为与该人工椎间盘 置换节段椎间隙的轴线平行或重合的贯通该关节的直线。
一个更具体的人工椎间盘方案: 所述上关节和下关节通过球窝结构相配合, 所述可撤 除式固定连接结构包括如下结构要素: 设置在上关节和下关节之间的环形体, 所述环形体 为充气式结构, 当环形体充满气体或液体时, 环形体的内环内设置所述球窝结构, 且环形 体上端顶住上关节、 下端顶住下关节; 环形体与上、 下关节之间的摩擦力限制了所述运动; 撤除环形体内的气体或液体, 就撤除了对所述运动的限制。
另一个更具体的人工椎间盘方案: 所述上关节和下关节通过球窝结构相配合, 所述可 撤除式固定连接结构包括如下结构要素: 设置在上关节和下关节之间的环形体, 环形体的 内环内设置所述球窝结构, 且环形体可沿该人工椎间盘置换节段椎间隙的轴线方向移动; 当环形体顶住上关节, 在环形体和上关节之间形成摩擦力, 在下关节上设置可撤除式支撑 体支撑环形体时, 限制了所述运动; 撤除所述支撑体, 就撤除了对所述运动的限制。 所述 环形体与上关节接触端面与上关节对应端的端面相适应。 所述可撤除式支撑体为设置有弹 簧的销, 弹簧被销和下关节夹住, 弹簧的伸縮方向平行于销的轴线, 当弹簧处于伸展状态 销向远离下关节体方向伸展支撑环形体, 且环形体上设置有与销接触部位相适应的凹槽; 当弹簧被压縮到一定程度, 销向下关节体方向回退, 撤除对环形体的支撑。 所述销的材质 为磁性材料。
还有一种可能的方案是所述可撤除式支撑体为固定支撑环形体的支撑件, 所述支撑件 的材质为可降解材料。
本发明的技术效果: 针对现有技术中存在的如下问题: 在骨质长入人工椎间盘接触表面之前的时间段里, 由于人工椎间盘的运动导致上、 下关节与相邻椎体终板下骨结合面产生不稳定性从而延迟 上、 下关节与相邻椎体终板下骨的结合的过程, 本发明采用的主要方法是在上述时间段内 固定上关节和下关节的位置关系, 使上关节和下关节形成一个 "整体", 虽然该 "整体"也 会运动从而在上、 下关节在相邻椎体终板下骨结合面上产生不稳定性, 但相比于上关节和 下关节均具有一定活动自由度而在相邻椎体终板下骨结合面上产生的不稳定性, "整体"运 动对于形成生物固定的稳定程度更高, 大大降低了上、 下关节与相邻椎体终板下骨结合面 产生的不稳定性, 因此可以创造一个良好的力学环境使得骨质长入人工椎间盘接触表面形 成牢固的生物固定。 待骨质长入人工椎间盘接触面后, 撤除上关节与下关节之间的固定连 接, 使人工椎间盘恢复应有的活动功能。
本发明的人工椎间盘在现有的人工椎间盘结构基础上增加了临时性的上、 下关节固定 连接结构, 实现了前述在骨质生长阶段固定上、下关节的目的, 同时在条件适当的时候(上 关节和下关节与相邻椎体终板下骨形成生物固定后) 可以撤消固定连接结构, 使得上、 下 关节之间可以相对运动, 使人工椎间盘恢复应有的活动功能。 附图说明
图 1为本发明的人工椎间盘各部件位置关系图。
图 2为装配好的人工椎间盘的剖视图。
图 3为本发明人工椎间盘中销的一个实例。
图 4为本发明人工椎间盘中销的另一个实例。
图 5为本发明人工椎间盘中销的第三个实例。
图 6为本发明人工椎间盘中销的第四个实例。
图中标识说明如下:
1、 结合面; 2、 突起; 3、 上关节; 4、 球头; 5、 环形体; 6、 凹槽; 7、 下关节; 8、 销孔; 9、 销; 10、 紧固环; 11、 弹簧; 12、 弹簧。 具体实施方式
对本发明的人工椎间盘安装方法进行详细说明。
将人工椎间盘的上关节和下关节按照既定的位置关系 (参考图 1 所示的上关节和下关 节位置关系) 安装, 即将上关节和下关节通过突起 2分别固定设置于人工椎间盘相邻椎体 终板下骨上。 由于相邻椎体终板下骨会对 关节和下关节自上、 下两个方向形成压力, 这 对于人工椎间盘与基体骨之间的结合牢固非常有利, 特别是在骨质还没有长入结合面 (即 形成生物固定前) 时更为有利。
在按上述步骤设置好上关节和下关节后, 在上关节和下关节之间建立固定连接关系, 这种连接关系使得上关节和下关节形成相互制约, 制约另一关节的运动趋势。 根据前面的 分析, 造成现有临床问题的一个主要原因就在于上关节或下关节与相邻椎体终板下骨之间 形成生物固定前存在的运动, 因此上述固定连接对上关节与下关节的运动的限制可以保证 上关节和下关节与相邻椎体终板下骨形成良好的生物固定。 建立上述固定连接的方法有很 多种现有方法, 在此不进行列举。
在完成上述步骤后, 检测上关节与下关节与相邻椎体终板下骨的结合状态, 如果上关 节与下关节均与所固接的椎体终板下骨实现生物固定, 则通过无创手术或微创方法断开上 述固定连接, 恢复人工椎间盘应有的全部活动功能。
至此, 本发明的人工椎间盘安装方法解决了现有技术存在的人工椎间盘植入人体后与 相邻段结合延迟和不结合的问题。
研究表明, 在上关节和下关节与椎体终板下骨形成生物固定前这段期间内, 对形成所 述生物固定有着严重危害的运动主要有以下几种: 上关节或下关节相对于下关节或上关节 的移动, 移动方向为与该人工椎间盘置换节段椎间隙的轴线垂直的方向; 上关节和 /或下关 节绕自身旋转轴线的转动, 旋转轴线为与该人工椎间盘置换节段椎间隙的轴线平行或重合 的贯通该关节的直线。
对以上运动进行如下说明, 上关节或下关节相对于下关节或上关节的移动是指上关节 与下关节之间的相对移动, 特别是在与该人工椎间盘所在椎间隙的轴线 (该椎间隙是该人 工椎间盘所置换的节段所在的椎间隙) 垂直的方向上具有移动分量的移动。 人体脊柱有四 个曲度 (颈曲、 胸曲、 腰曲和骶曲), 上述移动分量的移动方向就是以人工椎间盘所在椎间 隙的轴线 (近似直线) 为参照。 上关节或下关节相对于下关节或上关节的一个移动可以被 分解成在空间内相交两个平面上的分运动 (移动分量), 如果将上述相交两个平面之一设定 为与该人工椎间盘所置换节段椎间隙的轴线垂直的平面, 且上关节或下关节的移动在该平 面内具有移动分量的话, 则这个移动对上关节和下关节与椎体终板下骨形成生物固定有着 严重的危害。
如下转动也会对上关节和下关节与椎体终板下骨形成生物固定有着严重的危害: 上关 节和 /或下关节绕自身旋转轴线的转动, 且旋转轴线为与该人工椎间盘置换节段椎间隙的轴 线平行或重合的贯通该关节的直线, 这里所参照的轴线和上一段所参照的轴线的定义相同。
为此, 本发明的人工椎间盘安装方法 上关节与下关节之间建立的固定连接关系至少 应当限制上述对形成生物固定有着严重危害的运动之一。
以下结合附图, 通过多个实例对可以实现上述方法的本发明的人工椎间盘技术方案进 行详细说明。
图 1 揭示了本发明人工椎间盘的一种实施方式。 本发明的人工椎间盘包括按照上、 下 位置关系配合的上关节 3和下关节 7, 上关节 3和下关节 7通过球窝结构进行配合, 球窝结 构是一种常见的活动连接结构, 通过球窝结构上关节 3和下关节 7可以相对转动, 实现天 然椎间盘具有的活动功能。 球窝结构至少包括球头 4和与球头 4相适应的球窝两个要素, 球头 4的表面可以相对于球窝的表面进行滑动, 形成球头 4相对于球窝转动的效果, 球头 4 并不限于标准的圆球, 可以是椭球体等。 本发明涉及的球窝结构可以是固定设置在上关节 或下关节的球头 4与设置在下关节或上关节对应的球窝构成的组合, 也可以是在上关节和 下关节上均设置球窝, 两个球窝之间设置一个独立的球体作为球头 4。
在上、 下关节之间设置可撤除式固定连接结构, 该固定连接结构能够使上、 下关节的 位置关系保持固定, 即使得上关节与下关节之间不产生相对运动, 同时该固定连接结构能 够被拆除或撤销, 从而使得上、 下关节之间的固定连接关系被撤除。 由于上关节与下关节 之间的一些相对运动对形成生物固定有不同程度的不利影响, 因此, 可撤除式固定连接结 构能够对上关节与下关节之间这些相对运动进行临时性限制, 这会对实现本发明目的有益。 当然, 图 1 所显示的实施例更是针对了对实现生物固定有着最不利影响的几种运动进行限 制, 更有利于实现本发明的目的。 这几种运动是: 上关节 3或下关节 7相对于下关节 7或 上关节 3 的移动, 移动方向为与该人工椎间盘所置换节段椎间隙的轴线垂直的方向; 上关 节 3和 /或下关节 Ί绕自身旋转轴线的转动, 旋转轴线为与该人工椎间盘置换节段椎间隙的 轴线平行或重合的贯通该关节的直线。 所谓的可撤除式固定连接结构使得人工椎间盘能够 实现本发明的方法, 即在特定时间段限制上关节 3与下关节 7之间的上述几种运动, 而后 可以通过撤除该固定连接结构断开上关节 3和下关节 7的固定连接关系。
图 1所示的实施方式中的可撤除式固定连接结构包括如下要素:使上关节 3和下关节 Ί 相配合的球窝结构, 球窝结构包括设置在上关节的球头 4和设置在下关节的相应的球窝。 还包括设置在上关节 3和下关节 Ί之间的环形体 5,所述球窝结构设置在环形体 5的内环内, 环形体 5可沿人工椎间盘所置换节段椎间隙的轴线方向移动, 即环形体 5套住球窝结构并 可以在一定范围 (图 1中的垂直方向) 内移动。 在下关节 7上对应环形体 5均匀分布设置 若干支撑环形体 5的销, 销伸入销孔 8, 图 1中可见的两个销孔 8事实上是一个贯穿下关节 的销孔的两端, 图 1中设置了两个销以便于对环形体 5形成稳定的支撑, 分别位于图 1中 下关节的前、 后两个位置。 在销孔 8中的:露在销孔 8外的部分与环形体 5接触, 对环形 体 5进行支撑,环形体 5与销接触的部位相应设置凹槽 6,使得销不但对环形体 5进行支撑, 还可以限制环形体 5的转动。销的位置最好使得环形体 5同时受到销和上关节体的夹持(图 1中是上关节的凸缘实现夹持), 增加环形体 5与上关节 3接触面的粗糙度, 这样环形体 5 与上关节 3之间可以产生较大的摩擦力, 这一摩擦力可以限制上关节 3或下关节 Ί相对于 下关节 7或上关节 3的移动, 具体的就是限制在与上关节 3和下关节 Ί构成的人工椎间盘 所置换节段椎间隙的轴线垂直的方向 (即平行于结合面 1 的平面内的任意方向) 上具有移 动分量的移动。
由于环形体 5已被限制绕自身轴线转动, 而上关节 3也被环形体 5限制不能够绕自身 旋转轴线 (旋转轴线为与该人工椎间盘置换节段椎间隙的轴线平行或重合的贯通该关节的 直线) 转动, 同时下关节 7与上关节 3之间存在固定连接关系, 因此下关节 7也不能够绕 自身旋转轴线 (旋转轴线为与该人工椎间盘置换节段椎间隙的轴线平行或重合的贯通该关 节的直线)。 至此, 图 1所示的实施例能够实现对所述生物固定有着最不利影响的几种运动 进行限制, 因此可以避免由这些运动导致的人工椎间盘植入初期的与相邻椎体终板下骨结 合延迟和不结合的问题。 在通过临床检查或放射学检查证实人体椎体骨质和人工椎间盘接 触表面的结合已经成功后 (即实现生物固定后), 可以将销撤除, 环形体 5在重力作用下落 下, 脱离与上关节 3的接触, 从而解除了对上关节 3的转动的限制, 使得人工椎间盘恢复 应有的运动功能。
还有一种实施方式, 与图 1技术方案对比, 区别在于无需设置销孔和销, 环形体 5采 用充气式结构, 所谓充气式结构是指环形体为密闭的中空结构, 当环形体被充入气体或液 体时, 环形体具有如图 1所示的结构, 当环形体中的气体和液体被释放出后, 环形体萎縮, 不具有如图 1 所示的结构, 类似于气球。 当环形体萎縮后, 体积要比充入气体或液体时的 体积小很多。 在本实例中, 当环形体被充入气体或液体后, 环形体上端顶住上关节、 下端 顶住下关节 (分别顶住上关节和下关节的凸缘), 将环形体与上、 下关节的接触界面均设置 成具有一定粗糙度的表面, 目的是使得环形体与上、 下关节的接触界面具有摩擦力, 该摩 擦力限制了环形体绕贯穿自身的旋转轴线的转动, 也限制了上关节与下关节之间的相对转 动。 环形体与上、 下关节的接触界面间的摩擦力还限制了上关节和下关节之间在人工椎间 盘置换节段椎间隙的轴线垂直的方向上产生相对移动的趋势。 至此, 这一实施例能够实现 对所述生物固定有着最不利影响的几种运动进行限制, 因此可以避免由这些运动导致的人 工椎间盘植入初期的与相邻椎体终板下骨结合延迟和不结合的问题。 在通过临床检查或放 射学检查证实人体椎体骨质和人工椎间盘接触表面的结合已经成功后 (实现生物固定), 可 以将环形体中的气体或液体释放, 撤除了 上述运动的限制, 使得人工椎间盘恢复应有的 运动功能。
如图 2所示的人工椎间盘装配结构, 可以看到环形体 5的径向尺寸并不是均匀的, 即 右侧的环的壁更厚一些, 事实上这一剖面图揭示了这样一个技术特征: 在上、 下关节形成 的球窝关节不在人工椎间盘正中心时, 应当尽可能使环形体 5和上关节 3接触的端面 (即 环形体 5上方一端的端面) 与上关节 3对应的端面 (即上关节 3的凸缘部分的面) 的形状 与面积相近似 (即两个端面相适应), 实现对上关节 3尽可能大的支撑面积。 这种方案会带 来如下好处: 对上关节 3的支撑面积越大, 越有利于上关节的结合面 1 (参见图 1 ) 更大面 积与椎体终板下骨紧密接触, 这会加快实现生物固定的过程。
结合图 3至图 6对图 1中销和销孔的结构进行说明。 本部分只是举出若干优选的实施 例, 本领域的技术人员可以根据这些思想制定出多种替代方案。
图 1中的销需要具有如下功能: 支撑环形体 5; 可以拆除或縮回销孔 8内从而撤除对环 形体 5的支撑。 以下实施例均围绕着这一目标设计。
首先看图 3所示销的结构, 柱状的销 9分为两段, 两段的径向尺寸不同, 销孔为两段 式阶梯孔, 由两段内径不同的同轴孔组成一个销孔, 小孔的孔径略大于销 9小的径向尺寸 且小于销 9大的径向尺寸。 销 9径向尺寸小的一段被套上螺旋弹簧, 弹簧的轴线与销 9的 轴线平行或重合。 弹簧在自然伸展状态轴向尺寸长于销 9径向尺寸小的一段的轴向长度, 弹簧的一端顶在销 9两段之间的交界 (肩) 处。 设置好弹簧的销 9从销孔径向尺寸大的一 端伸入销孔, 弹簧的另一端顶在阶梯孔的径向尺寸不同的两段的交界处。 当弹簧处于自然 伸展的状态, 销 9部分段探出销孔孔径大的一端外支撑环形体, 当销 9受到指向图 3左侧 方向的力时, 弹簧被压縮, 销 9退回到销孔内, 对环形体的支撑被撤除。 指向图 3左侧方 向的力可以是通过外力 (如微创手术)推销 9实现, 也可以采用磁性材料制备销 9, 当需要 时, 在图 3的左侧利用磁力作用于销 9, 销 9回退到销孔内, 磁力消失后, 由于环形体已经 落下, 销 9是否再探出销孔不会对上关节和下关节的运动产生影响。 采用磁性材料的方案 的好处是在使销 9 回退时只需在人体外适当位置设置磁铁即可, 不必在人体上开出创口, 减少了病人痛苦。
图 4显示了销的另一种结构, 销 9沿轴向分成 3段, 3段的径向尺寸不同, 从左至右径 向尺寸相比依次为大尺寸、 小尺寸、 中尺寸。 图 4 中的销孔也是两段式阶梯孔, 阶梯孔大 的孔径与销 9大径向尺寸相近, 阶梯孔小的孔径与销 9中径向尺寸相近。 阶梯孔小孔径的 孔内还设置有凸缘, 如图 4所示。 销 9在销孔中的设置如下: 销 9大径向尺寸段设置在阶 梯孔的大孔径段内 (图 4中的左侧), 销 9中径向尺寸段设置在阶梯孔小孔径段内且全部位 于凸缘的右侧, 凸缘所处位置的径向孔径 :于销 9小径向尺寸且小于销 9中径向尺寸。 螺 旋弹簧 12的两端分别顶在凸缘的右侧和销 9中径向尺寸段与小径向尺寸段的交界处。 从凸 缘到销 9大径向尺寸段间阶梯孔的孔壁上还嵌入设置有紧固环 10,弹簧 11分别顶在凸缘的 左侧和紧固环 10上, 紧固环 10采用聚乙烯材料制成。 图 4所示销的工作过程如下: 紧固 环 10和凸缘之间的弹簧 11处于压縮状态, 弹簧 12推顶销 9伸出销孔小径向尺寸端支撑环 形体; 当需要销 9回退向左侧移动时, 采用电磁场加热等加热方法加热熔化紧固环 10, 从 而使得弹簧 11伸展, 弹簧 11推顶销 9的大径向尺寸段向左移动, 当弹簧 11伸展的力大于 压縮弹簧 12的力时, 销 9向左移动, 销 9对环形体的支撑被撤除。 这种撤除支撑的方法仅 需在人体外实行电磁场加热, 不必对人体造成创口, 减少了病人的痛苦。
图 5显示的销的技术方案是这样的: 销孔为盲孔, 与销孔孔径相当的销的左端到销孔 的底部之间设置有弹性部件, 实现销 9在左、 右方向的移动, 即实现销 9对环形体的支撑 与撤除支撑功能。 弹性部件可以由遥控电路控制, 在需要销 9回退 (即向图 5中左侧移动) 时通过人体外遥控实现。
图 6所示的销没有复杂的机械结构, 只是一个在销孔内无法移动的销 9, 销 9采用可降 解材料制成, 所谓的可降解材料是指在人体内环境中可以逐步降解的材料, 如人工合成高 分子材料聚丙交酯 (聚乳酸)。 这一降解过程需要一定的时间, 当销 9降解到一定程度, 销 9支撑不住环形体时即撤除了对环形体的支撑。 降解过程中销 9还具有支撑环形体的能力, 因此降解过程可以被设计成与骨质在上、 下关节结合面生长好的时间相当, 实现本发明的 目的。 降解过程时间的控制通过对可降解材料的选择和 /或销 9几何尺寸的选择来实现。

Claims

权利 要求
1、 人工椎间盘安装方法, 包括如下步骤: 将人工椎间盘的相配合的上关节和下关节按 照上、 下位置关系分别固定设置于椎体终板下骨上;
其特征在于还包括在上关节和下关节之间建立固定连接关系的歩骤;
及在上关节与下关节均与所述椎体终板下骨实现生物固定后, 断开所述上关节和下关 节之间固定连接关系的步骤。
2、 根据权利要求 1所述人工椎间盘安装方法, 其特征在于所述固定连接关系至少限制 如下运动之一: 上关节或下关节相对于下关节或上关节的移动, 移动方向为与该人工椎间 盘置换节段椎间隙的轴线垂直的方向; 上关节和 /或下关节绕自身旋转轴线的转动, 旋转轴 线为与该人工椎间盘置换节段椎间隙的轴线平行或重合的贯通该关节的直线。
3、 人工椎间盘, 包括按照上、 下位置关系相配合的上关节和下关节, 其特征在于还包 括一个固定连接上关节与下关节的可撤除式固定连接结构。
4、 根据权利要求 3所述人工椎间盘, 其特征在于所述可撤除式固定连接结构固定连接 上关节和下关节后至少限制如下运动之一: 上关节或下关节相对于下关节或上关节的移动, 移动方向为与该人工椎间盘置换节段椎间隙的轴线垂直的方向; 上关节和 /或下关节绕自身 旋转轴线的转动, 旋转轴线为与该人工椎间盘置换节段椎间隙的轴线平行或重合的贯通该 关节的直线。
5、 根据权利要求 3或 4所述人工椎间盘, 其特征在于所述上关节和下关节通过球窝结 构相配合, 所述可撤除式固定连接结构包括如下结构要素: 设置在上关节和下关节之间的 环形体, 所述环形体为充气式结构, 当环形体充满气体或液体时, 环形体的内环内设置所 述球窝结构, 且环形体上端顶住上关节、 下端顶住下关节; 环形体与上、 下关节之间的摩 擦力限制了所述运动; 撤除环形体内的气体或液体, 就撤除了对所述运动的限制。
6、 根据权利要求 3或 4所述人工椎间盘, 其特征在于所述上关节和下关节通过球窝结 构相配合, 所述可撤除式固定连接结构包括如下结构要素: 设置在上关节和下关节之间的 环形体, 环形体的内环内设置所述球窝结构, 且环形体可沿该人工椎间盘置换节段椎间隙 的轴线方向移动; 当环形体顶住上关节, 在环形体和上关节之间形成摩擦力, 在下关节上 设置可撤除式支撑体支撑环形体时, 限制了所述运动; 撤除所述支撑体, 就撤除了对所述 运动的限制。
7、 根据权利要求 6所述人工椎间盘, 其特征在于所述环形体与上关节接触端面与上关 节对应端的端面相适应, 使环形体对上关节的支撑面积尽可能大。
S、 根据权利要求 6或 7所述人工椎间盘, 其特征在于所述可撤除式支撑体为设置有弹 簧的销, 弹簧被销和下关节夹住, 弹簧的伸缩方向平行于销的轴线, 当弹簧处于伸展状态
权利要求
销向远离下关节体方向伸展支撑环形体, 且环形体上设置有与销接触部位相适应的凹槽; 当弹簧被压縮到一定程度, 销向下关节体方向回退, 撤除对环形体的支撑。
9、 根据权利要求 8所述人工椎间盘, 其特征在于所述销的材质为磁性材料。
10、 根据权利要求 6或 7所述人工椎间盘, 其特征在于所述可撤除式支撑体为固定支 撑环形体的支撑件, 所述支撑件的材质为可降解材料。
PCT/CN2010/072787 2009-06-02 2010-05-14 人工椎间盘 WO2010139231A1 (zh)

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US8974529B2 (en) 2015-03-10
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EP2438890A1 (en) 2012-04-11
JP2012528611A (ja) 2012-11-15
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EP2438890A4 (en) 2013-11-06
US20120095562A1 (en) 2012-04-19

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