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WO2023065689A1 - 一种acaf术使用的颈椎前路钢板、内固定系统及其应用 - Google Patents

一种acaf术使用的颈椎前路钢板、内固定系统及其应用 Download PDF

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Publication number
WO2023065689A1
WO2023065689A1 PCT/CN2022/098485 CN2022098485W WO2023065689A1 WO 2023065689 A1 WO2023065689 A1 WO 2023065689A1 CN 2022098485 W CN2022098485 W CN 2022098485W WO 2023065689 A1 WO2023065689 A1 WO 2023065689A1
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WIPO (PCT)
Prior art keywords
lifting
acaf
steel plate
vertebral body
segment
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2022/098485
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English (en)
French (fr)
Inventor
史建刚
韩郸
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Shanghai Changzheng Hospital
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Shanghai Changzheng Hospital
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Priority to EP22734087.4A priority Critical patent/EP4420625A4/en
Priority to US17/791,828 priority patent/US12023072B2/en
Publication of WO2023065689A1 publication Critical patent/WO2023065689A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8028—Cushions, i.e. elements forming interface between bone plate and bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7059—Cortical plates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7074—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling
    • A61B17/7076—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling for driving, positioning or assembling spinal clamps or bone anchors specially adapted for spinal fixation
    • A61B17/7082—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling for driving, positioning or assembling spinal clamps or bone anchors specially adapted for spinal fixation for driving, i.e. rotating, screws or screw parts specially adapted for spinal fixation, e.g. for driving polyaxial or tulip-headed screws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8033—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers
    • A61B17/8042—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers the additional component being a cover over the screw head
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/846—Nails or pins, i.e. anchors without movable parts, holding by friction only, with or without structured surface
    • A61B17/848—Kirschner wires, i.e. thin, long nails
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8866—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices for gripping or pushing bones, e.g. approximators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8875—Screwdrivers, spanners or wrenches

Definitions

  • the invention relates to the technical field of medical devices, in particular to an anterior cervical plate used in ACAF, an internal fixation system and an application thereof.
  • the anterior approach is one of the commonly used surgical approaches for the cervical spine, and it is widely used in cervical degenerative diseases, trauma, deformities, tumors and other lesions.
  • the anterior cervical plate internal fixation system can provide strong fixation and is currently routinely used in anterior cervical surgery.
  • the plate internal fixation system used clinically is composed of a plate and several screws, which are divided into various types according to the locking method, static pressure or dynamic pressure, etc. No matter which type of steel plate is available, because the bone graft observation hole of the steel plate is relatively small, the method of use is to first insert the fusion device or bone graft block, and then place the steel plate for fixation.
  • the controllable antedisplacement and fusion (cervical spine anterior controllable antedisplacement and fusion, ACAF) surgery of cervical spine anterior longitudinal ligament ossification was pioneered by the inventor of the present application, Professor Shi Jiangang. Advantages, especially for long-segment, severe ossification of the posterior longitudinal ligament, or spinal stenosis caused by other reasons, have received widespread attention.
  • the anterior cervical plate/screw is used as a "suspension bridge" to move the cervical vertebral body and compression objects forward as a whole.
  • the current technical problem is that the conventional anterior plate used in OPLL disease cannot realize the ACAF technical concept-accurately lift the compression objects, cannot maintain the intervertebral physiological height and restore the ideal cervical physiological curvature.
  • the reasons are: 1. During the use of conventional anterior cervical plate, it is necessary to place the fusion cage first, and then carry out the lifting operation. However, after the fusion cage is placed, it may be clamped with the residual vertebral body, which will affect the subsequent forward movement operation. 2.
  • the conventional anterior plate needs to use the screws screwed into the screw holes on both sides. When the bilateral forces are unbalanced, the residual vertebral body may rotate. Thus affecting the effect of moving forward, and even causing neurological complications. All these lead to the ineffective effect of the traditional anterior plate in restoring the physiological curvature of the cervical spine during the operation, and it is easy to find that it is difficult to restore the physiological curvature during the operation, or the physiological curvature is lost after the operation.
  • the patent application CN109288571A submitted by the applicant in the early stage provides a cervical spine natural height fixing plate, which is provided with a plate body, and the plate body is provided with a fusion window, a locking piece and a screw fixing hole matched with a screw.
  • the minimum distance between the upper and lower sidewalls of the fusion window along the vertical axis is 38mm, and the minimum distance between the left and right sidewalls of the fusion window along the horizontal axis is 12.118mm.
  • the cervical spine natural height fixing plate is used in cervical discectomy.
  • the patent application CN109044572A submitted by the applicant earlier provides a lifting tool for cervical vertebral body advancement fusion.
  • the lifting tool includes a lifting fixed body, a stroke control body, a connecting rod, a movable handle, a fixed handle; one end of the stroke control body is connected to the lifting fixed body, and the other end is connected with the connecting rod; the movable handle is arranged on the outer peripheral surface of the connecting rod and is movably connected with the connecting rod; the fixed handle is arranged One end of the connecting rod; the stroke control body is provided with external threads, and the movable handle is provided with internal threads, and when the internal threads on the movable handle and the external threads on the stroke control body cooperate to screw in , a relative movement occurs between the stroke control body and the movable handle.
  • the lifting tool used for cervical vertebral body forward fusion can realize the controllable, vertical and stable lifting of the vertebral body.
  • anterior cervical plate and supporting internal fixation system suitable for ACAF surgery, which can realize the technical concept of ACAF precise lifting of compression objects, maintenance of intervertebral physiological height, and restoration of ideal cervical physiological curvature.
  • the first purpose of the present invention is to address the deficiencies in the prior art and to provide a technology suitable for ACAF surgery, which can realize accurate lifting of compression objects, maintain intervertebral physiological height, and restore ideal cervical spine physiological curvature.
  • the second purpose of the present invention is to address the deficiencies in the prior art and provide an internal fixation system suitable for use in ACAF, which includes the above-mentioned anterior cervical plate and can achieve ACAF smooth lifting and pulling of compression objects, effectively avoiding vertebrae. A damaged lifter.
  • the third purpose of the present invention is to address the deficiencies in the prior art, to provide the application of the ACAF internal fixation system, to achieve accurate, controllable, stable and safe lifting of compression objects in ACAF, and to significantly improve the surgical effect.
  • An anterior cervical plate used in ACAF operation is provided with a plate body and screw fixing holes, the head end and the tail end of the plate body are provided with fusion windows, the fusion window has a width ⁇ 8mm and a height ⁇ 10mm;
  • the central longitudinal axis of the steel plate body is provided with at least one elongated pulling groove, and the length direction of the pulling groove is consistent with the length direction of the steel plate body.
  • the anterior cervical plate used in the ACAF operation also includes an auxiliary plate.
  • the auxiliary plate covers the front side of the plate body and exposes the fusion window, lifting groove and screw fixation of the plate body. hole, and the auxiliary steel plate is fixed to the steel plate body.
  • the fixing method of the auxiliary steel plate and the steel plate body is screw fixing, bayonet anti-rotation or riveting; the shape of the auxiliary steel plate is the same as that of the steel plate body.
  • the number of the pulling groove is one, and the fusion window at the head end, the fusion window at the tail end and the pulling groove are connected.
  • the number of the lifting grooves is two or more, the fusion window at the head end is connected with the lifting groove near the head end, and the fusion window at the tail end is connected with the pulling groove near the tail end connected, the lifting grooves are not connected.
  • the screw fixing hole includes an end screw fixing hole and a side screw fixing hole, the end screw fixing hole is located at the head end and tail end of the steel plate body, and the side screw fixing hole The screw fixing holes are located on the left and right sides of the lifting groove.
  • the fusion window at the head end is below the end screw fixing hole at the head end, and the fusion window at the tail end is above the end screw fixing hole at the tail end.
  • the side screw fixing holes on the left and right sides of the lifting groove are arranged symmetrically.
  • the material of the steel plate body is stainless steel, silicon steel, carbon steel, titanium alloy, pure titanium, cobalt-nickel alloy or polymer material.
  • a kind of ACAF operation internal fixation system comprises the cervical spine anterior road steel plate and puller that above-mentioned ACAF operation uses.
  • the lifter includes a lifting nail and a screwdriver; the lifting nail is provided with a lifting fixed body, a first stroke control body, a mounting joint and a second stroke control body, and the second stroke control body is sleeved on the second stroke control body.
  • the outside of a stroke control body is provided with internal threads matching the external threads of the first stroke control body, and the surface of the second stroke control body is shaped with axial grooves;
  • the screwdriver is provided with a screwdriver handle, A screwdriver extension rod and a screwdriver sleeve head, the inside of the screwdriver sleeve head is provided with a groove matching the groove on the second stroke control body.
  • the application of the ACAF internal fixation system for ACAF surgery includes the following steps:
  • Step 1 preoperative preparation, including measuring the thickness of ossification
  • Step 2 Make an incision according to the length of the surgical segment and the condition of the patient's neck to expose the relevant vertebral bodies;
  • Step 3 for the treatment of the intervertebral space in the lifting segment, only the posterior longitudinal ligament needs to be exposed, and for lifting the intervertebral space at both ends, the posterior longitudinal ligament of the intervertebral space is bitten off to expose the dura mater;
  • Step 4 remove the bone in front of the vertebral body according to the thickness of the ossification of each segment;
  • Step 5 Slots are made on the opposite side of each vertebral body in the lifting segment, and then an anterior cervical plate of appropriate length and pre-curved for ACAF is placed on the front edge of the vertebral body, at the head and tail outside the lifting segment Install vertebral body nails on the vertebral bodies at both ends to the end screw fixing holes at the head end and tail end of the steel plate body; in the lifting groove, screw the lifting nails on the pre-lifted vertebral bodies;
  • Step 6 making grooves on the same side of each vertebral body in the lifting segment
  • Step 7 put a screwdriver on the lifting nail, and turn the handle of the screwdriver until each vertebral body in the lifting segment fits with the steel plate body;
  • Step 8 Insert a fusion device or bone graft block in the anterior and caudal intervertebral space near the lifting segment outside the lifting segment through the fusion window, and slot bone grafts on both sides of each vertebral body in the lifting segment , stop the bleeding, close the incision, and immobilize after operation.
  • an intervertebral fusion device when an intervertebral fusion device needs to be installed in the intervertebral space between the lifting segments, it is necessary to measure the size of each intervertebral space according to the trial model, and install an intervertebral fusion cage in the intervertebral space between the lifting segments. Fusion cage, and then the appropriate length and pre-curved ACAF anterior cervical plate was placed on the front edge of the vertebral body.
  • the vertebral body can be moved forward first, and then the intervertebral fusion device can be inserted to ensure the effect of vertebral body forward movement to the greatest extent.
  • the lifting groove is located in the center of the steel plate body, which avoids the rotation phenomenon during the lifting process of the compression reduction body, and the lifting groove is in the shape of a longitudinal strip, which can be pulled at any position to achieve precise and controllable decompression.
  • the fusion window is only set at the cranial and caudal ends, and it is used for fusion of the intervertebral space at the cranial and caudal ends of the lifting segment.
  • the intervertebral space between the vertebral bodies in the lifting segment is still placed for fusion first
  • the lifting device consists of two parts, a lifting nail and a screwdriver.
  • the longer screwdriver drives the second stroke control body to lift the cone, which is beneficial to the stable lifting of the vertebral body, and the force on the steel plate is also more uniform. The possible damage to the vertebral body caused by the operation is avoided.
  • the anterior cervical plate and lifter used in the ACAF of the present invention can realize the technical concept of ACAF - the height of the physiological intervertebral space, the precise and controllable decompression of the lifting compression complex, Restore the best physiological curvature, make the operation simple, reliable and accurate, reduce the complications, reduce the risk of operation, and improve the curative effect of the operation.
  • FIG. 1 is a front view of the anterior cervical plate used in the ACAF operation of Example 1
  • FIG. 2 is a perspective view of the anterior cervical plate used in the ACAF operation of Example 1.
  • the anterior cervical plate used in the ACAF operation is provided with a plate body 1 .
  • the head end and tail end of the steel plate body 1 are respectively provided with two end screw fixing holes 2, and the two end screw fixing holes 2 are located on the left and right sides respectively, and an end screw locking member is arranged between them.
  • the steel plate body 1 is also provided with two rectangular fusion windows 4, one of which is located under the end screw fixing hole 2 at the head end of the steel plate body 1, and the other fusion window 4 is located at the end of the tail end of the steel plate body 1 Above the screw fixing hole 2.
  • the minimum distance (length) between the upper and lower sidewalls of each fusion window 4 along the vertical axis is 10mm
  • the minimum distance (width) between the left and right sidewalls of each fusion window 4 along the horizontal axis is 8mm.
  • the steel plate body 1 is also provided with a lifting groove 5 , the lifting groove 5 is a long groove, and its length direction is consistent with the length direction of the steel plate body 1 . Described lifting groove 5 width is 36mm, and length is 1020mm.
  • the pulling groove 5 communicates with the two fusion windows 4 at the head end and the tail end to form an "I" shape.
  • the left and right sides of the lifting groove 5 are respectively provided with a side screw fixing hole 6, and each side screw fixing hole 6 is equipped with a side screw locking member 7.
  • the side screw fixing holes 6 and the side screw locking parts 7 on the left and right sides are symmetrically distributed.
  • the anterior cervical plate used in the ACAF operation of this embodiment can be customized according to the strength of the plate and the physiological structure of the patient.
  • An example is: the plate body 1 has a thickness of 3.5 mm, a length of 51 mm, and a width of 16 mm.
  • the central axis of the end screw fixing hole 2 at the head end deviates 20° toward the head end, and the center axis of the end screw fixing hole 2 at the tail end deviates 20° toward the tail end.
  • the central axis of each end screw fixing hole 2 is inclined 6° to the inside.
  • the anterior cervical plate used in the ACAF operation of this embodiment is suitable for lifting a single vertebral body.
  • Preoperative preparation fully evaluate the positive and lateral position of the cervical spine, hyperextension and flexion, and perform tracheal movement training; use imaging techniques to measure the thickness of ossification, the anteroposterior diameter of the vertebral body, the curvature of the cervical spine, the width of the ossification, and the intervertebral space height and location of the spinal cord;
  • the thickness of bone in the front of the vertebral body removed is theoretically the same as the thickness of the ossification in the back of the vertebral body; when the thickness of the ossification exceeds 6 mm, the lifting distance can be further increased by using a curved titanium plate;
  • the specific operation of the contralateral grooving above is as follows: take the anterior foot of the uncinate process as the anatomical landmark of the longitudinal osteotomy, select the ossification 1 mm outward as the grooving boundary, and use the lamina rongeur to bite off the cortex after reaching the posterior wall of the vertebral body. The posterior wall of the remaining vertebral body at the bottom of the groove;
  • FIG. 3 is a front view of the anterior cervical plate used in the ACAF operation of Example 2
  • FIG. 4 is a perspective view of the anterior cervical plate used in the ACAF operation of Example 2.
  • the anterior cervical plate used in the ACAF operation is provided with a plate body 1 .
  • the head end and tail end of the steel plate body 1 are respectively provided with two end screw fixing holes 2, and the two end screw fixing holes 2 are located on the left and right sides respectively, and an end screw locking member is arranged between them.
  • the steel plate body 1 is also provided with two rectangular fusion windows 4, one of which is located under the end screw fixing hole 2 at the head end of the steel plate body 1, and the other fusion window 4 is located at the end of the tail end of the steel plate body 1 Above the screw fixing hole 2.
  • the minimum distance (length) between the upper and lower sidewalls of each fusion window 4 along the vertical axis is 10mm, and the minimum distance (width) between the left and right sidewalls of each fusion window 4 along the horizontal axis is 8mm.
  • the steel plate body 1 is also provided with two lifting grooves 5 , the lifting grooves 5 are elongated grooves, and the length direction is consistent with the length direction of the steel plate body 1 .
  • the pulling groove 5 has a width of 3-6mm and a length of 10-20mm.
  • the pulling groove 5 at the head end communicates with the fusion window 4 at the head end, and the pulling groove 5 at the tail end communicates with the fusion window 4 at the tail end.
  • a side screw fixing hole 6 is respectively provided on the left and right sides of each lifting groove 5 , and each side screw fixing hole 6 is equipped with a side screw locking member 7 .
  • the side screw fixing holes 6 and the side screw locking parts 7 on the left and right sides are symmetrically distributed.
  • the anterior cervical plate used in the ACAF operation of this embodiment can be customized according to the strength of the plate and the physiological structure of the patient.
  • An example is: the plate body 1 has a thickness of 3.5 mm, a length of 75 mm, and a width of 16 mm.
  • the central axis of the end screw fixing hole 2 at the head end deviates 20° toward the head end, and the center axis of the end screw fixing hole 2 at the tail end deviates 20° toward the tail end.
  • the central axis of each end screw fixing hole 2 is inclined 6° to the inside.
  • the anterior cervical plate used in the ACAF operation of this embodiment is suitable for lifting two vertebral bodies.
  • Preoperative preparation fully evaluate the positive and lateral position of the cervical spine, hyperextension and flexion, and perform tracheal movement training; use imaging techniques to measure the thickness of ossification, the anteroposterior diameter of the vertebral body, the curvature of the cervical spine, the width of the ossification, and the intervertebral space height and location of the spinal cord;
  • the thickness of bone in the front of the vertebral body removed is theoretically the same as the thickness of the ossification in the back of the vertebral body; when the thickness of the ossification exceeds 6 mm, the lifting distance can be further increased by using a curved titanium plate;
  • the specific operation of the contralateral grooving above is as follows: take the anterior foot of the uncinate process as the anatomical landmark of the longitudinal osteotomy, select the ossification 1 mm outward as the grooving boundary, and use the lamina rongeur to bite off the cortex after reaching the posterior wall of the vertebral body. The posterior wall of the remaining vertebral body at the bottom of the groove;
  • FIG. 5 is a front view of the anterior cervical plate used in the ACAF operation of Example 3
  • FIG. 6 is a perspective view of the anterior cervical plate used in the ACAF operation of Example 3.
  • the anterior cervical plate used in the ACAF operation is provided with a plate body 1 .
  • the head end and tail end of the steel plate body 1 are respectively provided with two end screw fixing holes 2, and the two end screw fixing holes 2 are located on the left and right sides respectively, and an end screw locking member is arranged between them.
  • the steel plate body 1 is also provided with two rectangular fusion windows 4, one of which is located under the end screw fixing hole 2 at the head end of the steel plate body 1, and the other fusion window 4 is located at the end of the tail end of the steel plate body 1 Above the screw fixing hole 2.
  • the minimum distance (length) between the upper and lower sidewalls of each fusion window 4 along the vertical axis is 10mm, and the minimum distance (width) between the left and right sidewalls of each fusion window 4 along the horizontal axis is 8mm.
  • the steel plate body 1 is also provided with five lifting grooves 5 , the lifting grooves 5 are elongated grooves, and the length direction is consistent with the length direction of the steel plate body 1 .
  • the pulling groove 5 has a width of 3-6mm and a length of 10-20mm.
  • Five pulling grooves 5 are arranged along the vertical axis on the steel plate body 1, wherein the pulling groove 5 at the head end communicates with the fusion window 4 at the head end, and the pulling groove 5 at the tail end communicates with the fusion window 4 at the tail end. 5 and the fusion window 4 form an "I" shape as a whole, but the adjacent pulling grooves 5 are not connected.
  • a side screw fixing hole 6 is respectively provided on the left and right sides of each lifting groove 5 , and each side screw fixing hole 6 is equipped with a side screw locking member 7 .
  • the side screw fixing holes 6 and the side screw locking parts 7 on the left and right sides are symmetrically distributed.
  • the anterior cervical plate used in the ACAF operation of this embodiment can be customized according to the strength of the plate and the physiological structure of the patient.
  • An example is: the plate body 1 has a thickness of 3.5 mm, a length of 147 mm, and a width of 16 mm.
  • the central axis of the end screw fixing hole 2 at the head end deviates 20° toward the head end, and the center axis of the end screw fixing hole 2 at the tail end deviates 20° toward the tail end.
  • the central axis of each end screw fixing hole 2 is inclined 6° to the inside.
  • the anterior cervical plate used in the ACAF operation of this embodiment is suitable for pulling five vertebral bodies.
  • Preoperative preparation fully evaluate the positive and lateral position of the cervical spine, hyperextension and flexion, and perform tracheal movement training; use imaging techniques to measure the thickness of ossification, the anteroposterior diameter of the vertebral body, the curvature of the cervical spine, the width of the ossification, and the intervertebral space height and position of the spinal cord;
  • the thickness of bone in the front of the vertebral body removed is theoretically the same as the thickness of the ossification in the back of the vertebral body; when the thickness of the ossification exceeds 6 mm, the lifting distance can be further increased by using a curved titanium plate;
  • the specific operation of the contralateral grooving above is as follows: take the anterior foot of the uncinate process as the anatomical landmark of the longitudinal osteotomy, select the ossification 1 mm outward as the grooving boundary, and use the lamina rongeur to bite off the cortex after reaching the posterior wall of the vertebral body. The posterior wall of the remaining vertebral body at the bottom of the groove;
  • FIG. 7 is a schematic diagram of the structure of the anterior cervical plate used in the ACAF operation of Example 4
  • FIG. 8 is a schematic diagram of the use state of the anterior cervical plate used in the ACAF operation of Example 4.
  • the anterior cervical plate used in the ACAF operation is provided with a plate body 1 .
  • the head end and tail end of the steel plate body 1 are respectively provided with two end screw fixing holes 2, and the two end screw fixing holes 2 are located on the left and right sides respectively, and an end screw locking member is arranged between them.
  • the steel plate body 1 is also provided with two rectangular fusion windows 4, one of which is located under the end screw fixing hole 2 at the head end of the steel plate body 1, and the other fusion window 4 is located at the end of the tail end of the steel plate body 1 Above the screw fixing hole 2.
  • the minimum distance (length) between the upper and lower sidewalls of each fusion window 4 along the vertical axis is 10mm, and the minimum distance (width) between the left and right sidewalls of each fusion window 4 along the horizontal axis is 8mm.
  • the steel plate body 1 is also provided with five lifting grooves 5 , the lifting grooves 5 are elongated grooves, and the length direction is consistent with the length direction of the steel plate body 1 .
  • the pulling groove 5 has a width of 3-6mm and a length of 10-20mm.
  • the lifting groove 5 at the head end communicates with the fusion window 4 at the head end, and the pulling groove 5 at the tail end communicates with the fusion window 4 at the tail end.
  • the rooms are not connected.
  • a side screw fixing hole 6 is respectively provided on the left and right sides of each pulling groove 5 , and each side screw fixing hole 6 is equipped with a side screw locking member 7 .
  • the side screw fixing holes 6 and the side screw locking parts 7 on the left and right sides are symmetrically distributed.
  • the anterior cervical plate used in the ACAF operation is also provided with an auxiliary plate 8 .
  • the shape of the auxiliary steel plate 8 is consistent with the shape of the steel plate body 1.
  • the auxiliary steel plate 8 is provided with an end screw fixing hole perspective window 82 at the position of each end screw fixing hole 2 of the corresponding steel plate body 1.
  • each end screw locking member 3 is provided with a perspective window 83 of the end screw locking member, and a fusion window perspective window 84 is provided at the position of each fusion window 4 corresponding to the steel plate body 1, and a fusion window perspective window 84 is provided at each position of the corresponding steel plate body 1.
  • the position of each pulling groove 5 is provided with a pulling groove perspective window 85
  • the position of each side screw fixing hole 6 corresponding to the steel plate body 1 is provided with a side screw fixing hole perspective window 86.
  • the position of each side screw lock 7 is provided with a side screw lock perspective window 87
  • each side screw fixing hole perspective window 86 is integrated with its corresponding side screw lock perspective window 87.
  • the auxiliary steel plate 8 is also provided with a second locking member 88, the second locking member 88 is specifically two thread locks, which respectively correspond to the first locking member 9 assembled on the steel plate body 1 in the use state,
  • the first locking member 9 is two threaded holes.
  • the anterior cervical plate used in the ACAF operation of this embodiment can be customized according to the strength of the plate and the physiological structure of the patient.
  • An example is: the plate body 1 has a thickness of 3.5 mm, a length of 147 mm, and a width of 16 mm.
  • the central axis of the end screw fixing hole 2 at the head end deviates 20° toward the head end, and the center axis of the end screw fixing hole 2 at the tail end deviates 20° toward the tail end.
  • the central axis of each end screw fixing hole 2 is inclined 6° to the inside.
  • the auxiliary steel plate 8 has a thickness of 3.5mm, a length of 147mm, and a width of 16mm.
  • the anterior cervical plate used in the ACAF operation of this embodiment is suitable for pulling five vertebral bodies.
  • Preoperative preparation fully evaluate the positive and lateral position of the cervical spine, hyperextension and flexion, and perform tracheal movement training; use imaging techniques to measure the thickness of ossification, the anteroposterior diameter of the vertebral body, the curvature of the cervical spine, the width of the ossification, and the intervertebral space height and location of the spinal cord;
  • the thickness of bone in the front of the vertebral body removed is theoretically the same as the thickness of the ossification in the back of the vertebral body; when the thickness of the ossification exceeds 6 mm, the lifting distance can be further increased by using a curved titanium plate;
  • the specific operation of the contralateral grooving above is as follows: take the anterior foot of the uncinate process as the anatomical landmark of the longitudinal osteotomy, select the ossification 1 mm outward as the grooving boundary, and use the lamina rongeur to bite off the cortex after reaching the posterior wall of the vertebral body. The posterior wall of the remaining vertebral body at the bottom of the groove;
  • the vertebral body ossification complex moves forward: put the screwdriver 12 on the lifting nail 11, rotate the screwdriver handle 121, and link the second stroke control body 114 to rotate, and lift the vertebral body through the reaction force with the steel plate , until each vertebral body in the lifting segment fits with the steel plate body;
  • the terms “vertical axis”, “longitudinal axis”, “transverse axis”, “coronal plane”, “horizontal plane” and “sagittal plane” are defined according to anthropometric reference plane and reference axis, see FIG. 11 .
  • the terms “head”, “tail”, “up”, “down”, “left” and “right” indicating orientation are all based on the viewing angle of the device of the present invention in use.
  • the terms “first” and “second” are used for descriptive purposes only, and should not be understood as indicating or implying relative importance.
  • the anterior cervical plate used in the ACAF operation of the present invention is provided with a fusion window 4 at the head end and the tail end of the steel plate body 1, and the size of the fusion window 4 is relatively large, allowing intervertebral fusion (10mm*5-8mm)
  • the plate can be placed and fixed first, and the lifting operation can be performed. After the lifting operation is completed and the plate is fixed, the fusion window at both ends can be passed. 4.
  • the fusion cage or bone graft block was placed to avoid the subsequent operation of forward movement caused by the clamping of the fusion cage with the residual vertebral body after the fusion cage was placed in the previous operation sequence, resulting in the obstruction of the forward movement of the cervical vertebral body and compressive objects, and the final operation
  • the recovery effect of the physiological curvature of the middle cervical spine is not obvious, and it is easy to find that it is difficult to restore the physiological curvature during the operation, or the physiological curvature is lost after the operation.
  • the pulling groove 5 is an elongated groove along the vertical axis direction, that is, the longitudinal axis direction of the steel plate body 1, and is located in the center of the longitudinal axis of the steel plate body 1, allowing the puller to pass through, thereby ensuring the vertical axis of each vertebral body.
  • Lifting is done at the center of the vertebral body, avoiding the rotation of the vertebral body during the lifting process, and the position of the lifting tool can be flexibly determined according to the size of the vertebral body and intervertebral disc of different patients, so that precise and controllable decompression can be achieved, and significantly reduced Nerve root pain and other complications occurred.
  • the fusion window 4 is only designed at the head end and the tail end, and is used to insert the fusion device in the intervertebral space at the head end and the tail end of the lifting segment, while the intervertebral space in the lifting segment is still placed in the fusion device or
  • the reason is that in our clinical practice, we found that the vertebral body of the lifting segment is already in a free state, so when the intervertebral space is first inserted into a fusion device or a bone graft and then pulled, because each vertebral body has a certain degree of freedom, so it is not easy to affect the precise lifting of the vertebral body, and this design ensures the overall strength of the steel plate.
  • the fusion window 4 is connected with its adjacent lifting groove 5, because the fusion window is the position of the intervertebral space, and the middle position is the vertebral body endplate, and the vertebral body position near the endplate has higher strength , The stronger the holding force of the lifting nail is placed here, the greater the lifting force.
  • the design of connecting the fusion window and the lifting groove makes it easier to place the lifting nail at the best place. For the case where the number of lifting grooves 5 is two or more, the lifting grooves 5 are not connected. In fact, the lifting grooves should be designed as a whole, which is convenient for free selection of the best placement of lifting nails. For a long steel plate, the lifting groove corresponding to the length of the steel plate will affect the strength of the steel plate.
  • the design of the interval is The mechanical strength of the steel plate is increased, and the intervertebral space fusion site is located at the spacer, where the spacer placement does not affect the placement of the free choice of lifting screws.
  • the auxiliary steel plate 8 is beneficial to increase the strength of the steel plate during the operation, and can obviously and reliably restore the overall physiological curvature of the cervical spine during and after the operation.
  • the auxiliary steel plate 8 is preferably the same shape as the steel plate body 1, which can fully cover the steel plate body 1, buffer the force received by the steel plate body 1 during the fixing process or the vertebral body pulling process, and protect various parts of the steel plate body 1.
  • the side screw fixing holes 6 and the side screw locking parts 7 on the left and right sides of the lifting groove 5 are all symmetrically arranged, the symmetry of the screw fixing holes and the consistency of the nails make the strength of the holding force of the two nails superimposed, Reach the maximum lifting and fixing strength.
  • the shape of the fusion window 4 of the present invention is not limited to a rectangle, but may also be oval, circular, square and other shapes.
  • the width of the pulling groove 5 is preferably 3-6 mm, and the length is preferably 10-20 mm.
  • the auxiliary steel plate 8 and the steel plate body 1 need to be fixed during the operation, but the fixing method is not limited to buckle anti-rotation, screw tightening and riveting.
  • the steel plate body 1 can be made of any material that meets the clinical vertebral fixation strength and safety requirements, such as stainless steel, silicon steel, carbon steel, titanium alloy, pure titanium, cobalt-nickel alloy, polymer material, etc.
  • anti-skid lines can be designed, such as anti-skid particles, water ripples and the like.
  • the anterior cervical plate used in the ACAF operation of the present invention is not only suitable for the ACAF operation to treat various types of OPLL diseases of the cervical spine, but also can be routinely used in the surgical treatment of cervical spine degeneration, fractures, tumors and other diseases.
  • FIG. 9 is a structural schematic diagram of the lifter used in the ACAF operation of Example 5
  • FIG. 10 is a schematic structural diagram of the lifter used in the ACAF operation of Example 5.
  • the lifter includes a lift nail 11 and a screwdriver 12 .
  • the lifting nail 11 is provided with a lifting fixing body 111 , a first stroke control body 112 , an installation joint 113 and a second stroke control body 114 .
  • One end of the first stroke control body 112 is connected to the lifting fixed body 111 , and the other end is connected to the installation joint 113 , and the first stroke control body 112 is provided with an external thread.
  • the second stroke control body 114 is sleeved on the outside of the first stroke control body 112 , and has an internal thread matching the external thread of the first stroke control body 112 .
  • the internal thread on the second stroke control body 114 and the external thread on the first stroke control body 112 cooperate and screw in, relative motion occurs between the first stroke control body 112 and the second stroke control body 114, and the first The movement direction of the stroke control body 112 and the second stroke control body 114 is coaxial.
  • the outer surface of the second stroke control body 114 is shaped with an axial groove 1141 .
  • the screwdriver 12 is provided with a screwdriver handle 121 , a screwdriver extension rod 122 and a screwdriver sleeve head 123 .
  • the lower end of the screwdriver extension rod 122 and the screwdriver sleeve head 123 are hollow, and the inside of the screwdriver sleeve head 123 is provided with a groove matching the groove 1141 on the second stroke control body 114, and the inner diameter of the screwdriver extension rod 122 is the same as The maximum outer diameters of the second stroke control bodies 114 are equal.
  • the method of using the lifter used in the ACAF of the present invention is as follows: in the ACAF, use a socket screwdriver that matches the installation joint 113 of the lift nail 11 to move the lift fixation body 111 of the lift nail 11 along the direction of the steel plate.
  • the lifting groove is implanted into the vertebral body to be lifted, remove the sleeve screwdriver, confirm the implantation depth through perspective, and then insert the screwdriver 12 along the top of the lifting nail 11, and control the second stroke of the lifting nail 11 after insertion.
  • the body 114 just corresponds to the position of the screwdriver sleeve head 123, and the grooves of the two are matched and engaged.
  • the second stroke control body 114 is rotated in conjunction with the reaction force of the steel plate to lift the vertebral body.
  • the lifter used in the ACAF technique of the present invention includes two detachable parts, the lift nail 11 and the screwdriver 12, and the second stroke control body 114 is driven by the longer screwdriver 12 to lift the cone.
  • the second-stroke control body 114 lifts the cone, and the force received by the second-stroke control body 114 is more uniform, so the vertebral body can also be lifted steadily under the action of a more uniform force, and the force on the steel plate is also more uniform, which can effectively prevent The relative twist of the plate relative to the craniocaudal vertebral body outside the lifting segment.
  • the relative twist of the plate relative to the craniocaudal vertebral body outside the lifting segment can effectively prevent The relative twist of the plate relative to the craniocaudal vertebral body outside the lifting segment.
  • the ACAF internal fixation system of the present invention includes the anterior cervical plate used in the ACAF described in any one of Embodiments 1-4 and the lifter used in the ACAF described in Embodiment 5, wherein the lifter of the lifter is The maximum outer diameter of the pulling fixation body is smaller than the width of the pulling groove of the anterior cervical spine plate.

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Abstract

一种ACAF术使用的颈椎前路钢板、提拉器及内固定系统。颈椎前路钢板的头端和尾端均设有宽度≥8mm，高度≥10mm的融合窗口(4)，中央纵轴上设有至少一个长条形的提拉槽(5)，还可进一步包括辅助钢板(8)，使用时辅助钢板(8)覆于钢板本体(1)的前侧。提拉器包括提拉钉(11)和起子(12)，提拉钉(11)设有第一和第二行程控制体(112、114)，起子(12)设有套接于第二行程控制体(114)外部并带动其旋动的起子套筒头(123)。内固定系统包括颈椎前路钢板和提拉器。能够实现ACAF技术理念——生理椎间隙高度，提拉致压复合体减压精准可控，恢复最佳生理曲度，使手术简化、可靠、精准，减少并发症，降低手术风险，提高手术疗效。

Description

一种ACAF术使用的颈椎前路钢板、内固定系统及其应用 技术领域
本发明涉及医疗器械技术领域，具体地说，是一种ACAF术使用的颈椎前路钢板、内固定系统及其应用。
背景技术
前方入路是颈椎常用的手术入路之一，其在颈椎退变性疾病、创伤、畸形、肿瘤等病变中广泛应用。颈前路钢板内固定系统能够提供坚强的固定，目前在颈椎前路手术中常规使用。临床使用的钢板内固定系统均由一块钢板与若干螺钉组成，其中又根据锁钉方式、静力加压或动力加压等的不同分为多种型号。现有的不论哪种型号钢板，由于钢板的植骨观察孔较小，因此使用方法都是先置入融合器或植骨块，然后放置钢板固定。
颈椎后纵韧带骨化椎体的可控前移(cervical spine anterior controllable antedisplacement and fusion，ACAF)手术由本申请发明人史建刚教授首创，是近年颈椎前路新兴技术，具有安全性高、神经恢复好等优势，尤其适用于长节段、严重的后纵韧带骨化或其它原因引起的椎管狭窄，受到广泛关注。该手术在操作过程中，使用颈椎前路钢板/螺钉作为“吊桥”，将颈椎椎体及致压物作为一个整体进行前移。
目前存在的技术问题是，常规前路钢板用于OPLL疾病中均无法实现ACAF技术理念——精准提拉致压物，无法维持椎间生理高度以及恢复理想的颈椎生理曲度，原因在于：1、常规的颈前路钢板使用过程中需要先放置融合器，后进行提拉操作，而融合器置入后可能会与残余椎体卡紧，进而影响后续的前移操作，且这一现象在上下端的椎间隙表现尤为突出；2、利用“吊桥”原理进行前移操作时，常规前路钢板需借助两侧螺孔拧入的螺钉，双侧力量不均衡时可能会产生残留椎体的旋转，从而影响前移效果，甚至引起神经并发症。这都导致传统前路钢板在术中恢复颈椎的生理曲度效果不明显，易出现术中难以恢复生理曲度，或术后生理曲度丢失现象。
本申请人前期提交的专利申请CN109288571A提供了一种颈椎自然高度固定板，其设有板体，所述的板体上设有融合窗口、锁紧件和与螺钉配合的螺钉固定孔，所述的融合窗口上、下两侧壁沿垂直轴方向的最小距离为3 8mm，融合窗口左、右两侧壁沿横轴方向的最小距离为12.1 18mm。该颈椎自然高度固定板是用于颈椎间盘切除术中使用。发明人在长期临床工作中总结发现，植骨融合器本身是大于椎间盘高度的，以保证与相邻椎体形成挤压，促进成骨，但同时会导致上、下椎体被撑开，如果有多个椎间盘被切除，则导致多个节段撑开过多，造成颈椎失去自然高度，引起脖子疼痛的手术并发症。因此将固定板的融合窗口设计得足够大，能够容许融合器通过，术中在摘除椎间盘后，先固定椎体再植入融合器，解决了因融合器植入导致的椎体被过度撑开失去自然高度而引发脖子疼痛的技术问题。
本申请人前期提交的专利申请CN109044572A提供了一种用于颈椎椎体前移融合术的提拉工具，所述的提拉工具包括提拉固定体、行程控制体、连接杆、活动手柄、固定手柄；所述的行程控制体一端连接提拉固定体，另一端和连接杆建立连接；所述的活动手柄设置在连接杆的外周面，并与连接杆活动连接；所述的固定手柄设置在连接杆的一端端部；所述的行程控制体上设有外螺纹，所述的活动手柄中设有内螺纹，且当活动手柄上的内螺纹和行程控制体上的外螺纹相配合旋进时，行程控制体与活动手柄之间产生相对运动。该用于颈椎椎体前移融合术的提拉工具能够实现椎体可控的，垂直的、稳定性好的提拉。
而目前未见适用于ACAF术使用，可实现ACAF术精准提拉致压物、维持椎间生理高度、恢复理想的颈椎生理曲度的技术理念的颈椎前路钢板及配套的内固定系统。
发明内容
本发明的第一个目的是针对现有技术中的不足，提供一种适用于ACAF术使用，可实现ACAF术精准提拉致压物、维持椎间生理高度、恢复理想的颈椎生理曲度的技术理念的颈椎前路钢板。
本发明的第二个目的是针对现有技术中的不足，提供一种适用于ACAF术使用的内固定系统，其包括上述颈椎前路钢板以及可实现ACAF术平稳提拉致 压物、有效避免椎体受损的提拉器。
本发明的第三个目的是针对现有技术中的不足，提供ACAF术内固定系统的应用，实现ACAF术精准、可控、稳定、安全提拉致压物，显著提升手术效果。
为实现上述第一个目的，本发明采取的技术方案是：
一种ACAF术使用的颈椎前路钢板，设有钢板本体和螺钉固定孔，所述钢板本体其头端和尾端均设有融合窗口，所述融合窗口的宽度≥8mm，高度≥10mm；所述钢板本体其中央纵轴上设有至少一个长条形的提拉槽，所述提拉槽的长度方向与钢板本体的长度方向一致。
作为本发明的一个优选例，所述ACAF术使用的颈椎前路钢板还包括辅助钢板，使用时所述辅助钢板覆于钢板本体的前侧并暴露钢板本体的融合窗口、提拉槽和螺钉固定孔，且辅助钢板与钢板本体固定。
更优选地，所述辅助钢板与钢板本体的固定方式为螺纹固定、卡销防旋或铆定；所述辅助钢板与钢板本体的形状相同。
作为本发明的另一优选例，所述提拉槽的数量为一个，头端的融合窗口、尾端的融合窗口和提拉槽三者相连通。
作为本发明的另一优选例，所述提拉槽的数量为两个或两个以上，头端的融合窗口与近头端的提拉槽相连通，尾端的融合窗口与近尾端的提拉槽相连通，各提拉槽之间不连通。
作为本发明的另一优选例，所述螺钉固定孔包括端部螺钉固定孔和侧部螺钉固定孔，所述端部螺钉固定孔位于所述钢板本体的头端和尾端，所述侧部螺钉固定孔位于所述提拉槽的左右两侧。
更优选地，头端的融合窗口在头端的端部螺钉固定孔的下方，尾端的融合窗口在尾端的端部螺钉固定孔的上方。
更优选地，所述提拉槽其左右两侧的侧部螺钉固定孔是对称设置的。
作为本发明的另一优选例，所述钢板本体的材质是不锈钢、硅钢、碳钢、钛合金、纯钛、钴镍合金或高分子材料。
为实现上述第二个目的，本发明采取的技术方案是：
一种ACAF术内固定系统，包括上述的ACAF术使用的颈椎前路钢板和提 拉器。
所述提拉器包括提拉钉和起子；所述提拉钉设有提拉固定体、第一行程控制体、安装接头和第二行程控制体，所述第二行程控制体套接在第一行程控制体的外部，且设有与第一行程控制体的外螺纹相匹配的内螺纹，所述第二行程控制体外表面塑形有轴向的棱槽；所述起子设有起子手柄、起子延伸杆和起子套筒头，所述起子套筒头内部设有与第二行程控制体上的棱槽相匹配的棱槽。
为实现上述第三个目的，本发明采取的技术方案是：
ACAF术内固定系统的应用，用于ACAF手术，包括如下步骤：
步骤一，术前准备，包括测量骨化物的厚度；
步骤二，根据手术节段长度及患者颈部条件进行切口，显露相关椎体；
步骤三，对于提拉节段内的椎间隙的处理仅需要显露后纵韧带，对于提拉首尾两端椎间隙则咬除椎间隙后纵韧带，显露硬脊膜；
步骤四，根据各节段骨化物厚度去除椎体前部骨质；
步骤五，在提拉节段内的各个椎体的对侧开槽，再将合适长度和预弯的ACAF术使用的颈椎前路钢板放置于椎体前缘，在提拉节段外的首尾两端椎体上安装椎体钉到钢板本体头端和尾端的端部螺钉固定孔；在提拉槽内，在预提拉的椎体上拧入提拉钉；
步骤六，在提拉节段内的各个椎体的同侧开槽；
步骤七，在提拉钉上套上起子，旋动起子手柄，直到提拉节段内的各个椎体与钢板本体贴合即可；
步骤八，通过融合窗口在提拉节段外的近提拉节段的首尾椎间隙置入融合器或植骨块，并在提拉节段内的各个椎体的两侧开槽内植骨，止血，关闭切口，术后制动。
作为本发明的另一优选例，提拉节段之间的椎间隙需要安装椎间融合器时，需先根据试模测量各椎间隙大小，于提拉节段之间的椎间隙安装椎间融合器，再将合适长度和预弯的ACAF术使用的颈椎前路钢板放置于椎体前缘。
本发明优点在于：
1、钢板本体的头端和尾端设有扩大的融合窗口，可以先进行椎体前移操作，后置入椎间融合器，最大程度地保证了椎体前移效果。
2、提拉槽位于钢板本体的中央位置，避免了致压复位体提拉过程中出现旋转现象，且提拉槽为纵向条形，能在任意位置进行提拉，实现精准可控减压。
3、配有辅助钢板，保证强度，利于术中生理曲度的纠正，保证颈椎生理曲度的最佳恢复。
4、融合窗口仅设于头端和尾端，用于提拉节段外头端和尾端的椎间隙后置融合器融合，提拉节段内的椎体间的椎间隙仍是先置入融合器或植骨块，并不影响椎体精准提拉，而且还确保了钢板整体的强度。
5、提拉器包括提拉钉和起子两个部件，通过较长的起子带动第二行程控制体提拉锥体，有利于椎体的平稳提拉，钢板受力也更加均匀，最大程度地避免了手术对椎体可能造成的损伤。
总的来说，本发明的ACAF术使用的颈椎前路钢板和提拉器，即整个内固定系统，能够实现ACAF技术理念——生理椎间隙高度，提拉致压复合体减压精准可控，恢复最佳生理曲度，使手术简化、可靠、精准，减少并发证，降低手术风险，提高手术疗效。
附图说明
附图1是实施例1的ACAF术使用的颈椎前路钢板主视图。
附图2是实施例1的ACAF术使用的颈椎前路钢板立体图。
附图3是实施例2的ACAF术使用的颈椎前路钢板主视图。
附图4是实施例2的ACAF术使用的颈椎前路钢板立体图。
附图5是实施例3的ACAF术使用的颈椎前路钢板主视图。
附图6是实施例3的ACAF术使用的颈椎前路钢板立体图。
附图7是实施例4的ACAF术使用的颈椎前路钢板结构示意图。
附图8是实施例4的ACAF术使用的颈椎前路钢板使用状态示意图。
附图9是实施例5的ACAF术使用的提拉器结构示意图一。
附图10是实施例5的ACAF术使用的提拉器结构示意图二。
附图11是人体测量基准面和基准轴示意图。
附图12是两侧开槽完毕后的椎体纵向截面图。
具体实施方式
下面结合附图对本发明提供的具体实施方式作详细说明。
附图中涉及的附图标记和组成部分如下所示：
1.钢板本体 2.端部螺钉固定孔
3.端部螺钉锁紧件 4.融合窗口
5.提拉槽 6.侧部螺钉固定孔
7.侧部螺钉锁紧件 8.辅助钢板
82.端部螺钉固定孔透视窗 83.端部螺钉锁紧件透视窗
84.融合窗口透视窗 85.提拉槽透视窗
86.侧部螺钉固定孔透视窗 87.侧部螺钉锁紧件透视窗
88.第二锁紧件 9.第一锁紧件
11.提拉钉 111.提拉固定体
112.第一行程控制体 113.安装接头
114.第二行程控制体 1141.棱槽
12.起子 121.起子手柄
122.起子延伸杆 123.起子套筒头
实施例1
请参见图1和图2，图1是实施例1的ACAF术使用的颈椎前路钢板主视图，图2是实施例1的ACAF术使用的颈椎前路钢板立体图。
所述ACAF术使用的颈椎前路钢板设有钢板本体1。所述钢板本体1其头端和尾端均各设有两个端部螺钉固定孔2，两个端部螺钉固定孔2分别位于左右两侧且二者之间设有端部螺钉锁紧件3。所述钢板本体1上还设有两个长方形的融合窗口4，其中一个融合窗口4位于钢板本体1头端的端部螺钉固定孔2的下方，另一个融合窗口4位于钢板本体1尾端的端部螺钉固定孔2的上方。每个融合窗口4的上、下两侧壁沿垂直轴方向的最小距离(长度)为10mm，每个融合窗口4的左、右两侧壁沿横轴方向的最小距离(宽度)为8mm。所述钢板本体1上还设有提拉槽5，所述提拉槽5为长条形槽，长度方向与钢板本体1的长度方向一致。所述提拉槽5宽度为3 6mm，长度为10 20mm。所述提拉槽5与头端和尾端的两个融合窗口4连通构成“工”字形。所述提拉槽5的左右两侧均各设有一个侧 部螺钉固定孔6，且每个侧部螺钉固定孔6配设有一个侧部螺钉锁紧件7。左右两侧的侧部螺钉固定孔6、侧部螺钉锁紧件7是对称分布的。
本实施例的ACAF术使用的颈椎前路钢板可以根据钢板强度、患者的生理结构定制合适的规格，其中的一个例子为：钢板本体1厚度3.5mm，长度51mm，宽度16mm。位于头端的端部螺钉固定孔2其中心轴线向头端方向偏斜20°，位于尾端的端部螺钉固定孔2其中心轴线向尾端方向偏斜20°。各个端部螺钉固定孔2其中心轴线均向内侧偏斜6°。
本实施例的ACAF术使用的颈椎前路钢板适用于对单个椎体提拉的情形。
本实施例的ACAF术使用的颈椎前路钢板其使用方法为：
(1)术前准备：充分评估颈椎正侧位、过伸过屈位，进行气管推移训练；通过影像学技术详细测量骨化物厚度、椎体前后径、颈椎曲度、骨化物宽度、椎间隙高度和脊髓所处位置；
(2)行全身麻醉，采用仰卧位体位，根据手术节段长度以及患者颈部条件决定选择横切口或纵切口，进行切口，显露相关椎体；
(3)处理椎间隙：对于提拉节段内的椎间隙的处理仅需要显露后纵韧带，对于提拉首尾两端椎间隙则咬除椎间隙后纵韧带，显露硬脊膜；
(4)根据影像学技术详细测量得到的骨化物厚度，去除椎体前部骨质；
去除的椎体前部骨质厚度理论上与椎体后方的骨化物厚度相同；当骨化厚度超过6mm，可通过使用弯曲钛版进一步增加提拉距离；
(5)在提拉节段内的各个椎体的对侧(对侧是指远离手术者一侧)开槽，再将合适长度和预弯的ACAF术使用的颈椎前路钢板放置于椎体前缘，在提拉节段外的首尾两端椎体上安装椎体钉到钢板本体1头端和尾端的端部螺钉固定孔2，注意将椎体钉的钉尾拧至贴合钢板本体1即可；在提拉槽内，在预提拉的椎体上拧入提拉钉11；
上述对侧开槽的具体操作为：以钩突前脚作为纵向截骨的解剖标志，选择骨化物向外1mm作为开槽边界，至椎体后壁骨皮质后，使用椎板咬骨钳咬除槽底剩余椎体后壁；
(6)在提拉节段内的各个椎体的同侧(同侧是指靠近离手术者一侧)开槽，其具体操作同上述对侧开槽，两侧均开槽完毕后(如图12所示)进行下步操作；
(7)椎体骨化物复合体前移：在提拉钉11上套上起子12，旋动起子手柄121，联动第二行程控制体114转动，通过与钢板的反作用力将椎体进行提拉，直到提拉节段内的各个椎体与钢板本体贴合即可；
(8)通过融合窗口4在提拉节段外的近提拉节段的首尾椎间隙置入融合器或植骨块，并在提拉节段内的椎体的两侧开槽内植骨，止血，关闭切口，术后制动。
实施例2
请参见图3和图4，图3是实施例2的ACAF术使用的颈椎前路钢板主视图，图4是实施例2的ACAF术使用的颈椎前路钢板立体图。
所述ACAF术使用的颈椎前路钢板设有钢板本体1。所述钢板本体1其头端和尾端均各设有两个端部螺钉固定孔2，两个端部螺钉固定孔2分别位于左右两侧且二者之间设有端部螺钉锁紧件3。所述钢板本体1上还设有两个长方形的融合窗口4，其中一个融合窗口4位于钢板本体1头端的端部螺钉固定孔2的下方，另一个融合窗口4位于钢板本体1尾端的端部螺钉固定孔2的上方。每个融合窗口4的上、下两侧壁沿垂直轴方向的最小距离(长度)为10mm，每个融合窗口4的左、右两侧壁沿横轴方向的最小距离(宽度)为8mm。所述钢板本体1上还设有两个提拉槽5，所述提拉槽5为长条形槽，长度方向与钢板本体1的长度方向一致。所述提拉槽5宽度为3-6mm，长度为10-20mm。头端的提拉槽5与头端的融合窗口4连通，尾端的提拉槽5与尾端的融合窗口4连通，四者整体构成“工”字形但两个提拉槽5之间并不连通。每个提拉槽5的左右两侧均各设有一个侧部螺钉固定孔6，且每个侧部螺钉固定孔6配设有一个侧部螺钉锁紧件7。左右两侧的侧部螺钉固定孔6、侧部螺钉锁紧件7是对称分布的。
本实施例的ACAF术使用的颈椎前路钢板可以根据钢板强度、患者的生理结构定制合适的规格，其中的一个例子为：钢板本体1厚度3.5mm，长度75mm，宽度16mm。位于头端的端部螺钉固定孔2其中心轴线向头端方向偏斜20°，位于尾端的端部螺钉固定孔2其中心轴线向尾端方向偏斜20°。各个端部螺钉固定孔2其中心轴线均向内侧偏斜6°。
本实施例的ACAF术使用的颈椎前路钢板适用于对两个椎体提拉的情形。
本实施例的ACAF术使用的颈椎前路钢板其使用方法为：
(1)术前准备：充分评估颈椎正侧位、过伸过屈位，进行气管推移训练；通过影像学技术详细测量骨化物厚度、椎体前后径、颈椎曲度、骨化物宽度、椎间隙高度和脊髓所处位置；
(2)行全身麻醉，采用仰卧位体位，根据手术节段长度以及患者颈部条件决定选择横切口或纵切口，进行切口，显露相关椎体；
(3)处理椎间隙：对于提拉节段内的椎间隙的处理仅需要显露后纵韧带，对于提拉首尾两端椎间隙则咬除椎间隙后纵韧带，显露硬脊膜
(4)根据影像学技术详细测量得到的骨化物厚度，去除椎体前部骨质；
去除的椎体前部骨质厚度理论上与椎体后方的骨化物厚度相同；当骨化厚度超过6mm，可通过使用弯曲钛版进一步增加提拉距离；
(5)在提拉节段内的各个椎体的对侧(对侧是指远离手术者一侧)开槽，根据试模测量各椎间隙大小，于提拉节段之间的椎间隙安装椎间融合器；再将合适长度和预弯的ACAF术使用的颈椎前路钢板放置于椎体前缘，在提拉节段外的首尾两端椎体上安装椎体钉到钢板本体1头端和尾端的端部螺钉固定孔2，注意将椎体钉的钉尾拧至贴合钢板本体1即可；在提拉槽内，在预提拉的椎体上拧入提拉钉11；
上述对侧开槽的具体操作为：以钩突前脚作为纵向截骨的解剖标志，选择骨化物向外1mm作为开槽边界，至椎体后壁骨皮质后，使用椎板咬骨钳咬除槽底剩余椎体后壁；
(6)在提拉节段内的各个椎体的同侧(同侧是指靠近离手术者一侧)开槽，其具体操作同上述对侧开槽，两侧均开槽完毕后(如图12所示)进行下步操作；
(7)椎体骨化物复合体前移：在提拉钉11上套上起子12，旋动起子手柄121，联动第二行程控制体114转动，通过与钢板的反作用力将椎体进行提拉，直到提拉节段内的各个椎体与钢板本体贴合即可；
(8)通过融合窗口4在提拉节段外的近提拉节段的首尾椎间隙置入融合器或植骨块，并在提拉节段内的椎体的两侧开槽内植骨，止血，关闭切口，术后制动。
实施例3
请参见图5和图6，图5是实施例3的ACAF术使用的颈椎前路钢板主视图， 图6是实施例3的ACAF术使用的颈椎前路钢板立体图。
所述ACAF术使用的颈椎前路钢板设有钢板本体1。所述钢板本体1其头端和尾端均各设有两个端部螺钉固定孔2，两个端部螺钉固定孔2分别位于左右两侧且二者之间设有端部螺钉锁紧件3。所述钢板本体1上还设有两个长方形的融合窗口4，其中一个融合窗口4位于钢板本体1头端的端部螺钉固定孔2的下方，另一个融合窗口4位于钢板本体1尾端的端部螺钉固定孔2的上方。每个融合窗口4的上、下两侧壁沿垂直轴方向的最小距离(长度)为10mm，每个融合窗口4的左、右两侧壁沿横轴方向的最小距离(宽度)为8mm。所述钢板本体1上还设有五个提拉槽5，所述提拉槽5为长条形槽，长度方向与钢板本体1的长度方向一致。所述提拉槽5宽度为3-6mm，长度为10-20mm。五个提拉槽5在钢板本体1上沿着垂直轴方向排列，其中头端的提拉槽5与头端的融合窗口4连通，尾端的提拉槽5与尾端的融合窗口4连通，提拉槽5与融合窗口4整体构成“工”字形但相邻的提拉槽5之间并不连通。每个提拉槽5的左右两侧均各设有一个侧部螺钉固定孔6，且每个侧部螺钉固定孔6配设有一个侧部螺钉锁紧件7。左右两侧的侧部螺钉固定孔6、侧部螺钉锁紧件7是对称分布的。
本实施例的ACAF术使用的颈椎前路钢板可以根据钢板强度、患者的生理结构定制合适的规格，其中的一个例子为：钢板本体1厚度3.5mm，长度147mm，宽度16mm。位于头端的端部螺钉固定孔2其中心轴线向头端方向偏斜20°，位于尾端的端部螺钉固定孔2其中心轴线向尾端方向偏斜20°。各个端部螺钉固定孔2其中心轴线均向内侧偏斜6°。
本实施例的ACAF术使用的颈椎前路钢板适用于对五个椎体提拉的情形。
本实施例的ACAF术使用的颈椎前路钢板其使用方法为：
(1)术前准备：充分评估颈椎正侧位、过伸过屈位，进行气管推移训练；通过影像学技术详细测量骨化物厚度、椎体前后径、颈椎曲度、骨化物宽度、椎间隙高度和脊髓所处位置；
(2)行全身麻醉，采用仰卧位体位，根据手术节段长度以及患者颈部条件决定选择横切口或纵切口，进行切口，显露相关椎体；
(3)处理椎间隙：对于提拉节段内的椎间隙的处理仅需要显露后纵韧带，对于提拉首尾两端椎间隙则咬除椎间隙后纵韧带，显露硬脊膜
(4)根据影像学技术详细测量得到的骨化物厚度，去除椎体前部骨质；
去除的椎体前部骨质厚度理论上与椎体后方的骨化物厚度相同；当骨化厚度超过6mm，可通过使用弯曲钛版进一步增加提拉距离；
(5)在提拉节段内的各个椎体的对侧(对侧是指远离手术者一侧)开槽，根据试模测量各椎间隙大小，于提拉节段之间的椎间隙安装椎间融合器；再将合适长度和预弯的ACAF术使用的颈椎前路钢板放置于椎体前缘，在提拉节段外的首尾两端椎体上安装椎体钉到钢板本体1头端和尾端的端部螺钉固定孔2，注意将椎体钉的钉尾拧至贴合钢板本体1即可；在提拉槽内，在预提拉的椎体上拧入提拉钉11；
上述对侧开槽的具体操作为：以钩突前脚作为纵向截骨的解剖标志，选择骨化物向外1mm作为开槽边界，至椎体后壁骨皮质后，使用椎板咬骨钳咬除槽底剩余椎体后壁；
(6)在提拉节段内的各个椎体的同侧(同侧是指靠近离手术者一侧)开槽，其具体操作同上述对侧开槽，两侧均开槽完毕后(如图12所示)进行下步操作；
(7)椎体骨化物复合体前移：在提拉钉11上套上起子12，旋动起子手柄121，联动第二行程控制体114转动，通过与钢板的反作用力将椎体进行提拉，直到提拉节段内的各个椎体与钢板本体贴合即可；
(8)通过融合窗口4在提拉节段外的近提拉节段的首尾椎间隙置入融合器或植骨块，并在提拉节段内的椎体的两侧开槽内植骨，止血，关闭切口，术后制动。
实施例4
请参见图7和图8，图7是实施例4的ACAF术使用的颈椎前路钢板结构示意图，图8是实施例4的ACAF术使用的颈椎前路钢板使用状态示意图。
所述ACAF术使用的颈椎前路钢板设有钢板本体1。所述钢板本体1其头端和尾端均各设有两个端部螺钉固定孔2，两个端部螺钉固定孔2分别位于左右两侧且二者之间设有端部螺钉锁紧件3。所述钢板本体1上还设有两个长方形的融合窗口4，其中一个融合窗口4位于钢板本体1头端的端部螺钉固定孔2的下方，另一个融合窗口4位于钢板本体1尾端的端部螺钉固定孔2的上方。每个融合窗口4的上、下两侧壁沿垂直轴方向的最小距离(长度)为10mm，每个融合窗口4 的左、右两侧壁沿横轴方向的最小距离(宽度)为8mm。所述钢板本体1上还设有五个提拉槽5，所述提拉槽5为长条形槽，长度方向与钢板本体1的长度方向一致。所述提拉槽5宽度为3-6mm，长度为10-20mm。头端的提拉槽5与头端的融合窗口4连通，尾端的提拉槽5与尾端的融合窗口4连通，两个融合窗口与五个提拉槽整体构成“工”字形但提拉槽5之间并不连通。每个提拉槽5的左右两侧均各设有一个侧部螺钉固定孔6，且每个侧部螺钉固定孔6配设有一个侧部螺钉锁紧件7。左右两侧的侧部螺钉固定孔6、侧部螺钉锁紧件7是对称分布的。所述ACAF术使用的颈椎前路钢板还设有辅助钢板8。所述辅助钢板8的形状和钢板本体1的形状一致，辅助钢板8在对应钢板本体1的各个端部螺钉固定孔2的位置设有端部螺钉固定孔透视窗82，在对应钢板本体1的各个端部螺钉锁紧件3的位置设有端部螺钉锁紧件透视窗83，在对应钢板本体1的每个融合窗口4的位置设有融合窗口透视窗84，在对应钢板本体1的每个提拉槽5的位置设有提拉槽透视窗85，在对应钢板本体1的每个侧部螺钉固定孔6的位置设有侧部螺钉固定孔透视窗86，在对应钢板本体1的每个侧部螺钉锁紧件7的位置设有侧部螺钉锁紧件透视窗87，每个侧部螺钉固定孔透视窗86和其所对应的侧部螺钉锁紧件透视窗87是一体的。所述辅助钢板8上还设有第二锁紧件88，所述第二锁紧件88具体为两个螺纹锁，使用状态下分别对应装配于钢板本体1上的第一锁紧件9，所述第一锁紧件9为两个螺纹孔。
本实施例的ACAF术使用的颈椎前路钢板可以根据钢板强度、患者的生理结构定制合适的规格，其中的一个例子为：钢板本体1厚度3.5mm，长度147mm，宽度16mm。位于头端的端部螺钉固定孔2其中心轴线向头端方向偏斜20°，位于尾端的端部螺钉固定孔2其中心轴线向尾端方向偏斜20°。各个端部螺钉固定孔2其中心轴线均向内侧偏斜6°。辅助钢板8厚度3.5mm，长度147mm，宽度16mm。
本实施例的ACAF术使用的颈椎前路钢板适用于对五个椎体提拉的情形。
本实施例的ACAF术使用的颈椎前路钢板其使用方法为：
(1)术前准备：充分评估颈椎正侧位、过伸过屈位，进行气管推移训练；通过影像学技术详细测量骨化物厚度、椎体前后径、颈椎曲度、骨化物宽度、椎间隙高度和脊髓所处位置；
(2)行全身麻醉，采用仰卧位体位，根据手术节段长度以及患者颈部条件决定选择横切口或纵切口，进行切口，显露相关椎体；
(3)处理椎间隙：对于提拉节段内的椎间隙的处理仅需要显露后纵韧带，对于提拉首尾两端椎间隙则咬除椎间隙后纵韧带，显露硬脊膜
(4)根据影像学技术详细测量得到的骨化物厚度，去除椎体前部骨质；
去除的椎体前部骨质厚度理论上与椎体后方的骨化物厚度相同；当骨化厚度超过6mm，可通过使用弯曲钛版进一步增加提拉距离；
(5)在提拉节段内的各个椎体的对侧(对侧是指远离手术者一侧)开槽，根据试模测量各椎间隙大小，于提拉节段之间的椎间隙安装椎间融合器；再将合适长度和预弯的ACAF术使用的颈椎前路钢板放置于椎体前缘，在提拉节段外的首尾两端椎体上安装椎体钉到钢板本体1头端和尾端的端部螺钉固定孔2，注意将椎体钉的钉尾拧至贴合钢板本体1即可；在提拉槽内，在预提拉的椎体上拧入提拉钉11；
上述对侧开槽的具体操作为：以钩突前脚作为纵向截骨的解剖标志，选择骨化物向外1mm作为开槽边界，至椎体后壁骨皮质后，使用椎板咬骨钳咬除槽底剩余椎体后壁；
(6)在提拉节段内的各个椎体的同侧(同侧是指靠近离手术者一侧)开槽，其具体操作同上述对侧开槽，两侧均开槽完毕后(如图12所示)进行下步操作；
(7)将辅助钢板8通过第一锁紧件9和第二锁紧件88的配合装配到钢板本体1上，将二者紧固；
(8)椎体骨化物复合体前移：在提拉钉11上套上起子12，旋动起子手柄121，联动第二行程控制体114转动，通过与钢板的反作用力将椎体进行提拉，直到提拉节段内的各个椎体与钢板本体贴合即可；
(9)拆下辅助钢板8；
(10)通过融合窗口4在提拉节段外的近提拉节段的首尾椎间隙置入融合器或植骨块，并在提拉节段内的椎体的两侧开槽内植骨，止血，关闭切口，术后制动。
针对以上实施例1-4，需要说明的是：
本文中，术语“垂直轴”、“纵轴”、“横轴”、“冠状面”、“水平面”、 “矢状面”按照人体测量基准面和基准轴来定义，参见图11。表示方位的术语“头”、“尾”、“上”、“下”、“左”、“右”均是基于本发明装置使用状态下的视角。术语“第一”、“第二”仅用于描述目的，而不能理解为指示或暗示相对重要性。
本发明的ACAF术使用的颈椎前路钢板，在钢板本体1的头端和尾端均设有融合窗口4，且融合窗口4的尺寸较大，允许椎间融合器(10mm*5-8mm)在钢板固定后再置入，相比于目前临床使用的颈前路钢板，可以实现先放置和固定钢板，进行提拉操作，提拉操作结束并在钢板固定确实后，再通过两端的融合窗口4置入融合器或植骨块，避免了以往手术操作顺序下因融合器置入后与残余椎体卡紧，影响后续前移操作，导致颈椎椎体及致压物前移受阻，最终术中颈椎生理曲度恢复效果不明显、易出现术中难以恢复生理曲度、或术后生理曲度丢失的情况。所述提拉槽5为沿着垂直轴方向即钢板本体1纵轴方向的长条形槽，且位于钢板本体1的纵轴的中央位置，允许提拉器通过，从而保证每个椎体的提拉均在椎体中央完成，避免了提拉过程中椎体的旋转，而且可针对不同患者椎体、椎间盘大小，灵活确定提拉工具位置，因此可实现精准可控减压，并显著减少神经根疼痛等并发证的发生。所述融合窗口4仅设计于头端和尾端，用于提拉节段外头端和尾端的椎间隙的融合器置入，而提拉节段内的椎间隙仍是先置入融合器或植骨块，原因在于我们临床实践中发现因提拉节段的椎体已处于游离状态，因此其椎间隙先置入融合器或植骨块再提拉时，由于各个椎体都具备一定的自由度，因此不容易出现影响椎体精准提拉的情况，而且该设计确保了钢板整体的强度。所述融合窗口4和其邻近的提拉槽5是相连通的，这是因为融合窗是椎间隙的位置，向中间位是椎体终板，靠近终板的椎体位置具有较高的强度，此处放置提拉钉把持力越强，提拉力量大，融合窗和提拉槽相连的设计就便于把提拉钉放置于最佳处。对于提拉槽5的数量为两个或两个以上的情况，各提拉槽5之间并不相连通，实际上提拉槽本应设计为一个整体，便于自由选择最佳放置提拉钉的位置，对于长钢板来说，与钢板相应长度的提拉槽会影响到钢板的强度，因此，根据机械力学，在不影响放置提拉钉的情况下，放置几个间隔，间隔的设计是增加钢板的力学强度，并且间隔所在处为椎间隙融合处，此处放置间隔不影响自由选择提拉钉的放置。所述辅助钢板8利于术中增加钢板强度，术中术后均可明显可靠的恢复 颈椎整体生理曲度。辅助钢板8优选与钢板本体1形状相同，可以全面覆盖钢板本体1，缓冲钢板本体1在固定过程中或椎体提拉过程中受到的力，保护钢板本体1的各个部位。所述提拉槽5其左右两侧的侧部螺钉固定孔6和侧部螺钉锁紧件7均对称设置，螺钉固定孔的对称性，置钉的一致性，使两钉把持力强度叠加，达到提拉固定强度最大。
对于本发明融合窗口4的形状，其不仅限于长方形，还可以是椭圆形、圆形、正方形等其他形状。所述提拉槽5的宽度优选3-6mm，长度优选10-20mm。所述辅助钢板8与钢板本体1在术中是需要固定的，但其固定方式不仅限于卡扣防旋、螺丝钉拧紧、铆定形式。所述钢板本体1可以采用满足临床椎体固定强度和安全性要求的任一种材质，如不锈钢、硅钢、碳钢、钛合金、纯钛、钴镍合金、高分子材料等。在所述钢板本体1的表面，可以设计防滑的纹路，如防滑颗粒、水波纹等。本发明的ACAF术使用的颈椎前路钢板不仅适用于ACAF术治疗颈椎各种类型的OPLL疾病，还能常规用于颈椎退变、骨折、肿瘤等疾病的手术治疗。
实施例5
请参见图9和图10，图9是实施例5的ACAF术使用的提拉器结构示意图一，图10是实施例5的ACAF术使用的提拉器结构示意图二。所述提拉器包括提拉钉11和起子12。所述提拉钉11设有提拉固定体111、第一行程控制体112、安装接头113和第二行程控制体114。所述第一行程控制体112一端与提拉固定体111连接，另一端与安装接头113连接，第一行程控制体112设有外螺纹。所述第二行程控制体114套接在第一行程控制体112的外部，且设有与第一行程控制体112的外螺纹相匹配的内螺纹。当第二行程控制体114上的内螺纹和第一行程控制体112上的外螺纹相配合旋进时，第一行程控制体112与第二行程控制体114之间产生相对运动，且第一行程控制体112与第二行程控制体114的运动方向共轴向。所述第二行程控制体114外表面塑形有轴向的棱槽1141。所述起子12设有起子手柄121、起子延伸杆122和起子套筒头123。所述起子延伸杆122的下端和起子套筒头123是中空的，起子套筒头123内部设有与第二行程控制体114上的棱槽1141相匹配的棱槽，起子延伸杆122内径与第二行程控制体114的最大外径相等。
本发明的ACAF术使用的提拉器其使用方法为：ACAF术中，使用与提拉钉11的安装接头113相匹配的套筒螺丝刀，将提拉钉11的提拉固定体111沿钢板的提拉槽植入至需提拉的椎体内，移除套筒螺丝刀，透视确认植入深度，再将起子12沿提拉钉11的上方插入，插入后提拉钉11的第二行程控制体114正好对应于起子套筒头123的位置，两者的棱槽相匹配啮合，旋动起子手柄121，联动第二行程控制体114转动，通过与钢板的反作用力将椎体进行提拉。
本发明的ACAF术使用的提拉器包括提拉钉11和起子12两个可分离的部件，通过较长的起子12带动第二行程控制体114提拉锥体，相较于直接旋动第二行程控制体114提拉锥体，第二行程控制体114受到的力更加均匀，因此椎体也能在更均匀的力的作用下平稳的提升，同时钢板受到的力也更均匀，可有效防止钢板相对于提拉节段外的头尾端椎体的相对扭动。进而尽最大可能的避免了手术对椎体的伤害。
实施例6
本发明的ACAF术内固定系统包括实施例1-4任一所述的ACAF术使用的颈椎前路钢板和实施例5所述的ACAF术使用的提拉器，其中所述提拉器的提拉固定体的最大外径小于所述颈椎前路钢板的提拉槽的宽度。在二者的配合下，可最大程度地实现椎体的精确、可控、平稳、安全提拉，显著提升ACAF术的手术效果。
上所述仅为本发明较佳的实施例，并非因此限制本发明的实施方式及保护范围，对于本领域技术人员而言，应当能够意识到凡运用本发明说明书内容及图示所作出的等同替换和显而易见的变化所得到的方案，均应当包含在本发明的保护范围内。

Claims (14)

  1. 一种ACAF术使用的颈椎前路钢板，设有钢板本体和螺钉固定孔，其特征在于，所述钢板本体其头端和尾端均设有融合窗口，所述融合窗口的宽度≥8mm，高度≥10mm；所述钢板本体其中央纵轴上设有至少一个长条形的提拉槽，所述提拉槽的长度方向与钢板本体的长度方向一致。
  2. 根据权利要求1所述的ACAF术使用的颈椎前路钢板，其特征在于，所述ACAF术使用的颈椎前路钢板还包括辅助钢板，使用时所述辅助钢板覆于钢板本体的前侧并暴露钢板本体的融合窗口、提拉槽和螺钉固定孔，且辅助钢板与钢板本体固定。
  3. 根据权利要求2所述的ACAF术使用的颈椎前路钢板，其特征在于，所述辅助钢板与钢板本体的固定方式为螺纹固定、卡销防旋或铆定；所述辅助钢板与钢板本体的形状相同。
  4. 根据权利要求1所述的ACAF术使用的颈椎前路钢板，其特征在于，所述提拉槽的数量为一个，头端的融合窗口、尾端的融合窗口和提拉槽三者相连通。
  5. 根据权利要求1所述的ACAF术使用的颈椎前路钢板，其特征在于，所述提拉槽的数量为两个或两个以上，头端的融合窗口与近头端的提拉槽相连通，尾端的融合窗口与近尾端的提拉槽相连通，各提拉槽之间不连通。
  6. 根据权利要求1所述的ACAF术使用的颈椎前路钢板，其特征在于，所述螺钉固定孔包括端部螺钉固定孔和侧部螺钉固定孔，所述端部螺钉固定孔位于所述钢板本体的头端和尾端，所述侧部螺钉固定孔位于所述提拉槽的左右两侧。
  7. 根据权利要求6所述的ACAF术使用的颈椎前路钢板，其特征在于，头端的融合窗口在头端的端部螺钉固定孔的下方，尾端的融合窗口在尾端的端部螺钉固定孔的上方。
  8. 根据权利要求1所述的ACAF术使用的颈椎前路钢板，其特征在于，所述钢板本体的材质是不锈钢、硅钢、碳钢、钛合金、纯钛、钴镍合金或高分子材料。
  9. 一种ACAF术内固定系统，其特征在于，包括权利要求1所述的ACAF术使用的颈椎前路钢板和提拉器。
  10. 根据权力要求9所述的ACAF术内固定系统，其特征在于，所述提拉器包括提拉钉和起子；所述提拉钉设有提拉固定体、第一行程控制体、安装接头和第二行程控制体，所述第二行程控制体套接在第一行程控制体的外部，且设有与第一 行程控制体的外螺纹相匹配的内螺纹，所述第二行程控制体外表面塑形有轴向的棱槽；所述起子设有起子手柄、起子延伸杆和起子套筒头，所述起子套筒头内部设有与第二行程控制体上的棱槽相匹配的棱槽。
  11. 权利要求9所述的ACAF术内固定系统的应用，其特征在于，用于ACAF手术，包括如下步骤：
    步骤一，术前准备，包括测量骨化物的厚度；
    步骤二，根据手术节段长度及患者颈部条件进行切口，显露相关椎体；
    步骤三，对于提拉节段内的椎间隙的处理仅需要显露后纵韧带，对于提拉首尾两端椎间隙则咬除椎间隙后纵韧带，显露硬脊膜；
    步骤四，根据各节段骨化物厚度去除椎体前部骨质；
    步骤五，在提拉节段内的各个椎体的对侧开槽，再将合适长度和预弯的ACAF术使用的颈椎前路钢板放置于椎体前缘，在提拉节段外的首尾两端椎体上安装椎体钉到钢板本体头端和尾端的端部螺钉固定孔；在提拉槽内，在预提拉的椎体上拧入提拉钉；
    步骤六，在提拉节段内的各个椎体的同侧开槽；
    步骤七，在提拉钉上套上起子，旋动起子手柄，直到提拉节段内的各个椎体与钢板本体贴合即可；
    步骤八，通过融合窗口在提拉节段外的近提拉节段的首尾椎间隙置入融合器或植骨块，并在提拉节段内的各个椎体的两侧开槽内植骨，止血，关闭切口，术后制动。
  12. 根据权利要求11的应用，其特征在于，提拉节段之间的椎间隙需要安装椎间融合器时，需先根据试模测量各椎间隙大小，于提拉节段之间的椎间隙安装椎间融合器，再将合适长度和预弯的ACAF术使用的颈椎前路钢板放置于椎体前缘。
  13. 权利要求10所述的ACAF术内固定系统的应用，其特征在于，用于ACAF手术，包括如下步骤：
    步骤一，术前准备，包括测量骨化物的厚度；
    步骤二，根据手术节段长度及患者颈部条件进行切口，显露相关椎体；
    步骤三，对于提拉节段内的椎间隙的处理仅需要显露后纵韧带，对于提拉首尾两端椎间隙则咬除椎间隙后纵韧带，显露硬脊膜；
    步骤四，根据各节段骨化物厚度去除椎体前部骨质；
    步骤五，在提拉节段内的各个椎体的对侧开槽，再将合适长度和预弯的ACAF术使用的颈椎前路钢板放置于椎体前缘，在提拉节段外的首尾两端椎体上安装椎体钉到钢板本体头端和尾端的端部螺钉固定孔；在提拉槽内，在预提拉的椎体上拧入提拉钉；
    步骤六，在提拉节段内的各个椎体的同侧开槽；
    步骤七，在提拉钉上套上起子，旋动起子手柄，直到提拉节段内的各个椎体与钢板本体贴合即可；
    步骤八，通过融合窗口在提拉节段外的近提拉节段的首尾椎间隙置入融合器或植骨块，并在提拉节段内的各个椎体的两侧开槽内植骨，止血，关闭切口，术后制动。
  14. 根据权利要求13的应用，其特征在于，提拉节段之间的椎间隙需要安装椎间融合器时，需先根据试模测量各椎间隙大小，于提拉节段之间的椎间隙安装椎间融合器，再将合适长度和预弯的ACAF术使用的颈椎前路钢板放置于椎体前缘。
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