WO2017185754A1 - 一种仿生防脱位人工腰椎及椎间盘连接复合体 - Google Patents

一种仿生防脱位人工腰椎及椎间盘连接复合体 Download PDF

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Publication number
WO2017185754A1
WO2017185754A1 PCT/CN2016/108539 CN2016108539W WO2017185754A1 WO 2017185754 A1 WO2017185754 A1 WO 2017185754A1 CN 2016108539 W CN2016108539 W CN 2016108539W WO 2017185754 A1 WO2017185754 A1 WO 2017185754A1
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Prior art keywords
intervertebral disc
elliptical
cylinder
dislocation
bottom plate
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Ceased
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PCT/CN2016/108539
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English (en)
French (fr)
Inventor
贺西京
刘俭涛
张峰
贺高乐
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Xian Jiaotong University
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Xian Jiaotong University
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Priority to US15/762,833 priority Critical patent/US10751194B2/en
Publication of WO2017185754A1 publication Critical patent/WO2017185754A1/zh
Anticipated expiration legal-status Critical
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30841—Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30904—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves serrated profile, i.e. saw-toothed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442—Intervertebral or spinal discs, e.g. resilient
    • A61F2/4425—Intervertebral or spinal discs, e.g. resilient made of articulated components
    • A61F2002/443—Intervertebral or spinal discs, e.g. resilient made of articulated components having two transversal endplates and at least one intermediate component
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
    • A61F2310/00796—Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite

Definitions

  • the invention belongs to the technical field of medical prosthesis manufacturing, in particular to a prosthetic transplantation for lumbar vertebral body and adjacent intervertebral disc disease resection, and a bionic anti-dislocation artificial lumbar vertebrae and intervertebral disc connection complex capable of retaining lumbar motion function.
  • the lumbar vertebra is located in the lower part of the human spine, the vertebral body is larger, the upper and lower endplates are kidney-shaped, and the central part of the endplate is slightly depressed at the back.
  • the vertebral body and the vertebral body are connected by the anterior wide and narrow intervertebral disc to form a physiological curvature.
  • An important load-bearing organ for the human body In the normal human body, due to the role of the intervertebral disc, the vertebral body has a certain rotation, lateral bending, flexion, and extension function.
  • the above-mentioned diseases are usually treated with titanium cage bone grafting combined with nail rod internal fixation after the lesion is removed.
  • the surgical approach is divided into simple anterior approach, simple posterior approach and anterior combined approach. Because of the immediate and long-term stability of this procedure, it is widely used by spine surgeons.
  • the operation generally integrates at least three adjacent vertebral bodies, and the fused vertebral body loses its normal active function, resulting in stress concentration and increased range of motion in the unfused segment, which may lead to adjacent intervertebral disc degeneration, secondary spinal stenosis, Serious complications such as articular process degeneration, acquired spondylolisthesis, instability.
  • some scholars have long-term follow-up found that patients with titanium cage bone graft fusion may have complications such as titanium cage subsidence, severe cases require reoperation.
  • the active center of the prosthesis is located in the center of the vertebral body, away from the intervertebral space, and the range of motion is small, which is inconsistent with the normal physiological state of the spine, which may lead to small joints in the long term. Sudden wear, calcification and unforeseen potential complications are not widely used.
  • the object of the invention is to overcome the shortcomings of the traditional fusion technique, fully absorb the advantages of the current artificial intervertebral disc and the artificial vertebral body, and to supplement the length and complement each other, and provide a bionic anti-dislocation artificial lumbar vertebrae and intervertebral disc connection complex.
  • the artificial lumbar spine and intervertebral disc connection complex includes a vertebral body member and an intervertebral disc member disposed at both ends of the vertebral body member, the intervertebral disc member including a curved L-plate and a composite material pad including the lumbar vertebral body respectively
  • the end plate and the side plate corresponding to the side shape and the side plate, the side plate is disposed on the bottom plate, the bottom plate and the composite material pad are connected by a ball and socket joint
  • the vertebral body member comprises an elliptical cylinder, an elliptical cylinder Grooves are formed on the two end faces of the body, and the composite mats of the two intervertebral disc members are respectively embedded in the grooves on the corresponding end faces of the elliptical cylinders.
  • the edge of the bottom plate is composed of an elliptical arc segment and an M-shaped curved segment which is smoothly connected with two ends of the elliptical arc segment, the elliptical arc segment being symmetric with a short axis corresponding to the ellipse, and the side plate is disposed at the On the elliptical arc segment of the edge of the bottom plate, the side plate is inclined inwardly and at an angle of 70 to 80 degrees with the bottom plate, and the side plate is provided with a screw hole.
  • the bottom plate is provided with an elliptical dome and a conical tooth protrusion, the elliptical dome and the conical tooth protrusion and the side plate are located on the same side surface of the bottom plate, the center of the elliptical dome and the The center of the bottom plate coincides, and the height of the elliptical dome decreases from the center to the periphery, and the conical dents are distributed along the elliptical line on the bottom plate.
  • the screw holes are two, and the two screw holes are not on the same horizontal plane.
  • the composite mat includes a recess embedded in a recess on a corresponding end surface of the elliptical cylinder An elliptical cylinder, an upper elliptical cylinder connected to the lower elliptical cylinder disposed at the opening position of the recess, and a composite sphere for use as a ball and socket joint joint head, the upper elliptical cylinder being provided with an opening having a circular shape a groove having a circular groove extending into the lower elliptical cylinder, the composite ball being disposed in the circular groove, wherein the composite ball and the upper elliptical column are open a gap is left between the circular grooves, and the gap is provided with a spherical shell for engaging with the composite ball for the ball and socket joint socket, the spherical shell and the cylinder disposed on the bottom plate
  • the protrusions are connected.
  • Two arcuate protrusions are disposed at an opening edge of the spherical shell, and the two arcuate protrusions are oppositely disposed.
  • the opening is a circular groove, and two notches are disposed on the wall surface, and the two notches are opposite in position.
  • the distance between the outer wall faces of the two arcuate projections is less than or equal to the distance between the two notches, and the pitch is greater than the diameter at the opening of the groove in which the opening is circular.
  • the curved protrusions are symmetrically distributed about the sagittal plane, the notches being symmetrically distributed about the coronal plane.
  • the cylindrical protrusion includes a large cylinder connected to the bottom plate and a small cylinder connected to the large cylinder, the spherical shell is connected to the small cylinder, and the large cylinder coincides with a center line of the small cylinder,
  • the contact surface ridge line of the large cylinder and the small cylinder is rounded and rounded, the top end of the composite sphere is higher than the upper elliptical cylinder, and the outer edge of the upper elliptical column and the opposite side surface of the bottom plate is rounded and rounded.
  • the inner edge of the surface (where the opening is a circular groove opening) is treated by a taper enlargement process.
  • the side surface of the elliptical cylinder is provided with a plurality of circular grooves randomly distributed, and the middle position of the elliptical cylinder is provided with two rectangular through grooves intersecting each other, and the two rectangular through grooves are respectively along the sagittal plane and the coronal plane walking.
  • the elliptical cylinder, the curved L-shaped plate and the composite material pad are respectively integrally formed, and the elliptical cylinder and the curved L-plate are made of medical titanium alloy, and the composite material pad is made of ultra-high molecular weight poly A material of ethylene or polyetheretherketone, wherein the curved L-plate is in contact with the bone surface and the side of the elliptical cylinder is provided with a hydroxyapatite coating.
  • One side of the elliptical cylinder is provided with an arc-shaped recess penetrating in the axial direction, and a side surface of the lower elliptical cylinder of the composite material pad is also provided with an arc-shaped recess penetrating in the axial direction, and an arc-shaped recess of the side surface of the elliptical cylinder is The arcuate depressions on the side of the lower elliptical cylinder of the composite mat are the same.
  • the side surface of the elliptical column of the composite material pad is provided with a limiting groove, and the inner wall of the limiting groove is machined with a zigzag structure, and the limiting groove is symmetrically distributed along the median sagittal plane of the lower elliptical column, and penetrates with the curved groove a limited-position composite material pad is installed in the limiting slot, and a side shape of the limiting composite material pad matches the shape of the large hemisphere, and the other side shape of the limiting composite material pad matches the shape of the outer wall of the composite material pad;
  • One side of the limiting composite material pad is also processed with a sawtooth structure, and the sawtooth structure on the side of the composite material pad matches the sawtooth structure on the inner wall of the limiting groove, and the limiting groove and the limiting composite material pad phase
  • the matching constitutes a limit device.
  • the size of the above-mentioned limiting groove and the limiting composite material pad can be adjusted.
  • the above-mentioned limiting composite material pad is processed by medical high molecular polyethylene or polyether ether ketone.
  • the bionic anti-dislocation artificial lumbar vertebrae and intervertebral disc connection complex of the invention fully considers the anatomical features of the lumbar vertebrae, and the curved L-plate is used for tightly binding with the adjacent vertebral body, effectively reducing the stress concentration of the contact surface and satisfying the bearing function of the normal lumbar vertebrae. Because of the existence of the ball and socket joint, it is closer to the physiological state, and the embedded connection between the composite pad and the end groove of the vertebral body member not only plays a buffering role, but also prevents the composite material pad from being caused by the widening of the intervertebral space during the movement. Prolapse in the vertebral body component.
  • the shape of the bottom plate of the curved L-shaped plate of the present invention is similar to the shape of the front portion of the lumbar vertebra end plate, and the elliptical dome is coincident with the depression at the center of the lumbar vertebra end plate, and the conical odontoid is provided at the upper portion and the periphery of the dome.
  • the bottom plate and the end plate are more tightly and firmly combined; the side plates of the curved L plate are closely attached to the side of the vertebral body, thereby increasing the contact area, effectively avoiding stress concentration, and the large cylindrical protrusion on the bottom plate can withstand well
  • the lateral shear force generated by the flexion and extension movement avoids the occurrence of adverse events such as deformation and breakage.
  • the side surface of the vertebral body member of the present invention is provided with a randomly distributed circular groove, which is beneficial to the adhesion of the surrounding tissue and the growth of the residual bone.
  • the two rectangular through grooves in the middle can accommodate more implanted bone, which is more conducive to The fusion with the surrounding tissue ensures long-term stability after surgery.
  • the curved L-shaped plate of the invention has a hydroxyapatite coating on the contact surface of the bone surface and the side surface of the vertebral body component, which is more conducive to the fusion with the surrounding tissue, and ensures the activity and stability.
  • the side plate of the curved L-shaped plate of the present invention is provided with two screw holes not on the same horizontal surface, and the side plates are firmly fixed on the adjacent vertebral bodies by screw insertion in different directions, thereby reducing loosening and disengaging. risk.
  • the limiting device according to the present invention can control the range of the axial rotation angle of the anti-ball joint joint by changing the size thereof, and avoid the damage of the small facet joint and surrounding soft tissue caused by excessive rotation of the axis.
  • Figure 1 is a front view of the present invention
  • Figure 2 is a rear elevational view of the present invention
  • Figure 3 is a side view of the present invention.
  • Figure 4 is a plan view of the present invention.
  • Figure 5 is a bottom view of the present invention.
  • Figure 6 is a cross-sectional view of the coronal plane of the present invention.
  • Figure 7 is a sagittal cross-sectional view of the present invention.
  • Figure 8 is an isometric view of the curved L-plate
  • Figure 9 is an isometric view of a composite mat
  • Figure 10 is an isometric view of a vertebral body component
  • Figure 11 is a schematic diagram of various parameters of the curved L-plate
  • Figure 12 is a schematic diagram of various parameters of the composite mat
  • Figure 13 is a schematic view of the bionic anti-dislocation artificial vertebral body and the intervertebral disc junction complex after implantation;
  • Figure 14 is an isometric view of another embodiment of a vertebral body member
  • Figure 15 is an isometric view of another embodiment of a composite mat
  • Figure 16 is a plan view of the limiting composite mat
  • Figure 17 is a horizontal sectional view of a ball and socket joint
  • 1 is an elliptical cylinder
  • 2 is a deep groove
  • 3 is a curved L-plate
  • 4 is a composite pad
  • 5 is an elliptical dome
  • 6 is a conical tooth
  • 7 is a cylindrical protrusion
  • 8 is Arc-shaped protrusions
  • 9 is a near hemispherical shell
  • 10 is a side plate
  • 11 is a screw hole
  • 12 is an upper elliptical column
  • 13 is a lower elliptical column
  • 14 is an arcuate groove
  • 15 is a large hemisphere
  • 16 is a notch
  • 17 is The upper edge of the upper elliptical cylinder
  • 18 is the bottom plate
  • 19 is the ridgeline behind the bottom plate
  • 20 is the large cylinder
  • 21 is the small cylinder
  • 22 is the ridgeline of the large cylinder and the small cylinder
  • 23 is the arc groove opening
  • 24 is small Circular groove
  • 25 is
  • the biomimetic anti-dislocation artificial lumbar vertebrae and intervertebral disc connection complex of the present invention comprises a vertebral body member, an intervertebral disc member and a screw 27.
  • the vertebral body member is composed of an elliptical cylinder 1 having deep grooves 2 on the upper and lower sides.
  • one side of the elliptical cylinder 1 is provided with an arc-shaped recess 28 extending in the axial direction, and the side surface is provided.
  • the two rectangular through grooves 25 respectively travel along the sagittal plane and the coronal plane, the small circular grooves 24 facilitate the attachment of the surrounding tissue, and the rectangular through grooves 25 can be performed.
  • Two cylindrical grooves 26 are symmetrically arranged on the upper and lower sides of the rectangular through-groove opening along the coronal plane, which facilitates the operator to clamp and connect the composite body, and is convenient for surgical operation.
  • the disc member comprises two parts, an arcuate L-plate 3 connected to the adjacent vertebral body and a composite pad 4 connected to the vertebral body member, both of which are connected by an anti-ball joint.
  • the curved L-plate 3 is composed of a bottom plate 18, a curved side plate 10 and a cylindrical protrusion 7 having a large semi-elliptical shape, and the ridgeline 19 at the back of the bottom plate is rounded and rounded, and the adjacent vertebral body
  • the end plate contact surface is provided with an elliptical dome 5 and a conical tooth protrusion 6, the center of the elliptical dome 5 coincides with the center of the bottom plate 18, and the height of the elliptical dome 5 decreases from the center to the periphery, and the conical dentate 6 is evenly spaced along the elliptical line on the bottom plate 18;
  • the cylindrical protrusion 7 is disposed at the elliptical center of the bottom plate 18 opposite to the composite pad 4, and the cylindrical protrusion 7 includes a large cylinder 20 near the bottom plate 18 and a small cylinder away from the bottom plate 18.
  • the center lines of the two are coincident, the ridge line 22 of the large cylinder and the small cylinder contact surface is rounded and rounded, and the end of the small cylinder 21 is a structure of a near hemispherical shell 9 with two arcuate protrusions 8, the arc shape
  • the protrusions 8 are symmetrically distributed on both sides of the near hemispherical shell 9 with respect to the sagittal plane;
  • the curved side panel 10 has a quarter-elliptical cross section, is located at the left front edge of the bottom plate 18, and is gradually inclined inwardly, curved
  • the side plate 10 is provided with two screw holes 11 not in the same horizontal plane, and the screws are passed through the screws.
  • the curved L-plate 3 is firmly fixed to the side of the adjacent vertebral body.
  • the composite material pad 4 is composed of two upper and lower elliptical columns.
  • the upper elliptical column 12 is dug with an arcuate groove 14 around its center line, and a side of the lower elliptical column 13 is provided with an arc-shaped recess 29 extending in the axial direction.
  • 1 side curved depression 28 is the same shape as the arcuate recess 29 on the side of the lower elliptical column 13 of the composite material pad 4.
  • the side of the lower elliptical column 13 is provided with a limiting slot 30, and the inner wall of the limiting slot 30 is formed with a sawtooth structure 31, and the limiting slot 30 is down.
  • the elliptical column 13 is symmetrically distributed in the median sagittal plane, and penetrates the curved groove 14.
  • the limiting groove 30 is provided with a finite composite pad 32, and a side shape of the limiting composite pad 32 and the large hemisphere 15 The shape is matched, and the other side shape of the limiting composite material pad 32 is opposite to the shape of the outer wall of the composite material pad; a side surface of the limiting composite material pad 32 is also processed with a sawtooth structure 33, and the serration of the side surface of the composite material pad 32
  • the structure 33 matches the sawtooth structure 31 on the inner wall of the limiting slot 30 to prevent the limiting device from loosening and coming out; the limiting slot 30 and the limiting composite material pad 32 are matched to form a limiting device, and the limiting slot 30 is limited.
  • the size of the composite pad 32 can be adjusted, and the range of the axial rotation angle of the anti-ball joint is adjusted according to the size thereof, so that the axial rotation angle varies between 0 and 90 degrees.
  • the inner wall surface of the curved groove 14 is a large hemisphere 15 structure, and the outer wall of the curved groove 14 is provided with two small notches 16 in front of the outer wall, and the two small notches 16 are symmetrically distributed outside the curved groove 14 with respect to the coronal plane.
  • the top end of the large hemisphere 15 on the inner wall surface of the curved groove 14 is higher than the upper elliptical column 12, and the opening of the arcuate groove 14 is tapered to ensure the mobility of the flexion and extension movement and limit the excessive movement.
  • the outer diameter of the opening of the arcuate groove 14 is smaller than the distance between the outer wall surfaces of the two arcuate protrusions 8 on the near hemispherical shell 9, and the distance between the small indentations 16 of the arcuate groove is equal to the distance between the outer wall surfaces of the two arcuate protrusions 8.
  • the lower elliptical cylinder 13 of the composite material pad 4 is disposed in the deep groove 2 on the elliptical cylinder 1, which can effectively prevent the composite material mat from coming out of the groove.
  • the upper edge 17 of the upper elliptical cylinder 12 is rounded and rounded.
  • the structure of 9 is matched with the structure of the large hemisphere 15 of the upper elliptical cylinder to form a ball and socket joint.
  • the ball and socket joint ensures the rotation, lateral bending, flexion and back extension function of the adjacent vertebral body after operation, and the screws 27 are respectively located in the screw holes.
  • the lower elliptical cylinder of the composite pad is joined to the deep groove 2 of the vertebral body member to ensure the stability of the joining composite itself.
  • the curved groove 14 is a gap for receiving the near hemispherical shell 9.
  • the vertebral body member and the curved L-plate 3 and the screw 27 are integrally formed by a medical titanium alloy material, and the curved L-plate 3 and the cortical contact surface (such as the upper surface of the bottom plate and the inner surface of the curved side plate) and the side surface of the vertebral body member are provided with a hydroxyl group.
  • the apatite coating is more conducive to the fusion with the surrounding tissue, ensuring postoperative stability.
  • the composite material pad 4 is integrally formed by using ultra-high molecular polyethylene material or polyether ether ketone material, and the limiting composite material pad is also processed by medical high molecular polyethylene or polyetheretherketone, and the inner and outer walls of the curved groove 14 and Both the inner and outer sides of the structure of the near hemisphere shell 9 are polished, which can effectively reduce the friction of the contact surface.
  • the elliptical cylinder 1 of the vertebral body member is 26 mm high, the ellipse has a long radius of 23 mm, and the short radius is 15 mm.
  • the upper and lower grooves (deep grooves) are 10 mm deep, the long radius is 21 mm, and the short radius is 13 mm.
  • the two rectangular through grooves 25 have an opening of 3 mm ⁇ 15 mm, and the randomly distributed small circular grooves 24 have a depth of 1 mm and a radius of 1 mm, and the cylindrical grooves 26 have a depth of 1.5 mm and a radius of 1.5 mm.
  • the bottom plate 18 of the curved L plate 3 is about 2 mm thick, has a large semi-elliptical shape, has a curvature of 225°, an elliptical long radius of 23 mm, a short radius of 18 mm, and a ridgeline behind the bottom plate passes through a circle having a radius of 5 mm. Rounded corners.
  • the elliptical dome 5 on the bottom plate 18 has a center height of 2 mm and is tapered from the center to the periphery. The dome has a long radius of 15 mm and a short radius of 10 mm, and the center coincides with the center of the bottom plate.
  • the conical tooth projection 6 on the bottom plate 18 has a height of 0.5 mm and a bottom radius of 0.25 mm (only a part of the figure is shown). Toothed protrusions are for reference only).
  • the curved side plate 10 of the curved L-plate 3 is about 2 mm thick, has a quarter-elliptical shape, has a height of 12 mm, and is at an angle of 70 to 80 degrees with the bottom plate, and the screw hole 11 has a radius of 2 mm.
  • the upper elliptical column 12 of the composite material pad 4 is 3 mm high
  • the upper elliptical column has a long radius of 23 mm
  • the short radius is 15 mm
  • the lower elliptical column has a long radius of 21 mm, short.
  • the radius is 13mm
  • the upper edge of the upper elliptical cylinder is rounded and rounded with a radius of 2mm.
  • the cone height is 3 mm and is at an angle of 75 degrees ( ⁇ ) to the end of the upper elliptical cylinder.
  • the hydroxyapatite coating has a thickness of 20 ⁇ m.
  • the above parameters can be appropriately changed according to the difference in the size of the human lumbar vertebrae.
  • the bionic anti-dislocation artificial lumbar vertebrae and intervertebral disc connection complex assembly relationship of the present invention is as follows: the lower elliptical cylinder 13 of the composite material pad 4 is placed in the deep groove 2 of the elliptical cylinder 1, the curved L-plate 3
  • the structure of the near hemispherical shell 9 and the arcuate protrusion 8 at the end of the cylindrical protrusion 7 and the arcuate groove 14 on the composite material pad 4 constitute an anti-ball joint joint, and the contact surfaces of the ball and socket joint are highly polished to ensure the joint is in motion.
  • the screws 27 respectively fix the curved L-plate 3 to the adjacent vertebral body through the screw holes 11.
  • the shape of the bottom plate 18 of the curved L-plate is similar to that of the end plate, the elliptical dome 5 coincides with the depression on the end plate of the vertebral body, and the conical dent 6 makes the bottom plate 18 and the adjacent end
  • the plate combination is more firm, and the curved side plate 10 increases the contact area with the adjacent vertebral body, effectively reducing the stress concentration, thereby satisfying the weight bearing function of the lumbar spine.
  • the elliptical cylinder 1 is provided with a rectangular through-groove 25 and a randomly distributed small circular groove 24, which is more conducive to the adhesion and growth of surrounding tissues, and ensures long-term stability after surgery.
  • the anti-ball joints not only ensure the stability of the intervertebral disc after implantation, prevent the prosthesis from coming out, limit the axial rotation angle of the prosthesis, and retain the rotation, lateral bending, flexion and extension of the vertebral body. More in line with the physiological state of the human body.
  • the biomimetic anti-dislocation artificial lumbar vertebrae and intervertebral disc connection complex of the present invention comprises a vertebral body member, an intervertebral disc member and a screw.
  • the vertebral body member is composed of an elliptical cylinder 1 having deep grooves 2 on the upper and lower sides, and has a small circular groove 24 randomly distributed on the side and two rectangular through grooves 25 at the intermediate position.
  • the intervertebral disc member comprises two parts, namely an arcuate L plate 3 connected to an adjacent vertebral body and a composite material pad 4 connected to the elliptical cylinder 1, the curved L plate 3 being composed of a bottom plate 18, curved side plates 10 and cylindrical protrusions 7, the bottom plate 18 is provided with an elliptical dome 5 and a conical tooth protrusion 6, and the curved side plate 10 is provided with two screw holes 11 not in the same plane, and the end of the cylindrical protrusion 7 has two curved shapes.
  • the structure of the nearly hemispherical shell 9 of the protrusion 8; the composite material pad 4 is composed of two upper and lower elliptical columns, the lower elliptical column 13 is disposed in the deep groove of the elliptical cylinder 1, and the upper elliptical column 12 is dug around the center line with a curved concave
  • the groove 14 has a large hemisphere 15 structure on the inner surface of the groove, and the near hemispherical shell structure cooperates with the large hemispherical structure of the upper elliptical column to form a ball and socket joint, the joint surface is polished, and the hydroxyapatite coating is in contact with the bone surface. .
  • the invention not only can replace the vertebral body and the adjacent intervertebral disc removed in the lumbar spine operation, but also retains the rotation, flexion and extension of the intervertebral disc and a certain buffering function, thereby ensuring the stability after operation and retaining the activity of the lumbar vertebrae. Bionics is closer to the physiological state of the human body.

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

一种仿生防脱位人工腰椎及椎间盘连接复合体，包括椎体部件、椎间盘部件及螺钉（27）。椎体部件由上下两面带有深凹槽（2）的椭圆柱体（1）构成，椎间盘部件包括弧形L板（3）和复合材料垫（4），弧形L板（3）由底板（18）、弧形侧板（10）与圆柱状突起（7）构成，圆柱状突起（7）末端为带有两个弧形突起（8）的近半球壳（9）结构，复合材料垫（4）与椭圆柱体深凹槽（2）相连接，近半球壳（9）结构与复合材料垫（4）内的大半球体（15）结构相配合构成防脱球窝关节。该仿生防脱位人工腰椎及椎间盘连接复合体不但可以替代腰椎手术中取掉的椎体及邻近的椎间盘，而且保留了椎间盘的旋转、屈伸及一定的缓冲功能，并且整个结构设有防脱装置，既保证了术后的稳定性，又保留了腰椎的活动性，在仿生学上更接近人体生理状态。

Description

一种仿生防脱位人工腰椎及椎间盘连接复合体 技术领域
本发明属于医用假体制造技术领域，尤其涉及腰椎椎体及邻近椎间盘病变切除术后进行假体移植，可以保留腰椎活动功能的仿生防脱位人工腰椎及椎间盘连接复合体。
背景技术
腰椎位于人体脊柱的下段，椎体较大，上下终板呈肾型，终板中央偏后处略凹陷，椎体与椎体之间通过前宽后窄的椎间盘相连接，形成生理弯曲，是人体重要的承重器官。在正常人体中，因椎间盘的作用，椎体有一定旋转、侧弯、前屈、背伸功能，有研究报道20～30岁正常国人腰椎节段(L1/L2—L5/S1)屈伸活动度范围(Overlay法)：男性为14.15°～29.39°，女性为14.54°～26.61°。
腰椎结核、肿瘤、陈旧性骨折常导致脊柱侧弯、脊髓压迫等严重并发症，是严重威胁人体健康的一类疾病。目前，针对上述疾患通常采取病灶清除术后行钛笼植骨融合联合钉棒内固定治疗，手术入路分为单纯前路、单纯后路及前后联合入路。因该术式能够获得即刻及长期稳定性，被脊柱外科医生广泛采用。但是该手术一般至少融合三个邻近椎体，被融合椎体丧失了正常的活动功能，导致未融合节段应力集中及活动范围增加，长期可导致邻近椎间盘退变、继发性椎管狭窄、关节突关节退变、获得性脊椎滑脱、不稳等严重并发症。此外，有学者长期随访发现进行钛笼植骨融合的患者可能存在钛笼沉降等并发症，病情严重者需再次手术治疗。
为克服钛笼缺陷，人工椎体的改进一直备受关注，目前已由最初的单纯撑开型，发展到撑开固定型、可调固定型以及自固定型，制作材料也由原来的金属材质，发展到现在的陶瓷、高分子复合材料等多种材料并存。尽管人工椎体的发展使术后稳定性有所增加，个别假体甚至除去了钉棒系统的固定，减少了手术创伤，但因上述假体仍以融合固定为主，无法保留正常椎体的活动功能，因此仍无法避免融合固定后可能引起的并发症。虽然有学者研制出具有一定活动功能的人工椎体，但是该假体的活动中心位于椎体中央，远离椎间隙，而且活动范围较小，与脊柱的正常生理状态不符，长期可能会导致小关节突磨损、钙化及难以预料的潜在并发症，因此未得到广泛应用。
为保留椎体的活动功能，国内外众多学者致力于人工椎间盘的研究，目前市场上有多种人工椎间盘被应用于治疗颈、腰椎椎间盘病变，其中SB Charité Disc与Prodisc II在治疗腰椎病变中被广泛应用，在一项前瞻性随机对照研究中SB Charité Disc植入相对于植骨融合等内固定术在治疗腰背痛方面取得了更好的效果。但是有研究报道椎间盘植入后存在假体移位、脱落导致临近血管、神经的损伤，而且对于多阶段人工椎间盘植入可能造成脊柱不稳，对于存在合并椎体病变的患者，人工椎间盘将难以植入。
为解决上述难题，国内贺西京、雷伟等教授首次着力于人工椎体及椎间盘系统的研究，目前在颈椎方面已取得了可喜的成绩，仿生寰枢椎假体及下颈椎的人工椎体及椎间盘复合体在动物实验中取得了比较满意的效果。但是因腰椎解剖结构及生理功能的复杂，颈椎的人工椎体及椎间盘复合体难以应用于腰椎。人工腰椎及椎间盘连接复合体必需满足以下三点：1.保证植入后脊柱的即刻及长期稳定性；2.保留邻近椎体的运动功能；3.满足正常脊柱的承重功能；但是目前人工假体、人工椎间盘及下颈椎的人工椎体及椎间盘系 统均难以做到，查阅国内外相关文献亦未发现有关人工腰椎及椎间盘连接复合体的报道。
发明内容
本发明的目的在于克服传统融合技术的缺点，充分吸取目前人工椎间盘及人工椎体的优势，取长补短，提供一种仿生防脱位人工腰椎及椎间盘连接复合体。
为达到上述目的，本发明采用了以下技术方案：
该人工腰椎及椎间盘连接复合体包括椎体部件以及设置于椎体部件两端的椎间盘部件，所述椎间盘部件包括弧形L板以及复合材料垫，所述弧形L板包括分别与腰椎椎体的终板以及侧面形状相应的底板以及侧板，所述侧板设置于所述底板上，所述底板与复合材料垫之间通过球窝关节相连，所述椎体部件包括椭圆柱体，椭圆柱体的两个端面上开设有凹槽，两个椎间盘部件的复合材料垫分别嵌入在椭圆柱体的对应端面上的凹槽内。
所述底板的边缘由椭圆弧段以及与该椭圆弧段的两端圆滑过渡连接的M字型曲线段组成，所述椭圆弧段以对应椭圆的短轴对称，所述侧板设置于所述底板边缘的椭圆弧段上，所述侧板向内倾斜并与所述底板呈70～80度夹角，所述侧板上设置有螺孔。
所述底板上设置有椭圆状圆顶以及圆锥状齿突，所述椭圆状圆顶以及圆锥状齿突与所述侧板位于所述底板的同一侧表面，椭圆状圆顶的中心与所述底板中心重合，椭圆状圆顶高度由中心向四周递减，圆锥状齿突沿椭圆线间隔分布于所述底板上。
所述螺孔为两个，两个螺孔不在同一水平面上。
所述复合材料垫包括嵌入在所述椭圆柱体的对应端面上的凹槽内的下 椭圆柱、设置于该凹槽开口位置处的与所述下椭圆柱相连的上椭圆柱以及用于作为球窝关节关节头的复合材料球体，所述上椭圆柱上设置有开口为圆形的凹槽，该开口为圆形的凹槽延伸至下椭圆柱内，所述复合材料球体设置于所述开口为圆形的凹槽内，所述复合材料球体与所述上椭圆柱上开口为圆形的凹槽之间留有间隙，所述间隙内设置有与所述复合材料球体配合的用于作为球窝关节关节窝的球壳，所述球壳与设置于所述底板上的圆柱状突起相连。
所述球壳的开口边缘处设置有两个弧形突起，所述两个弧形突起位置相对，所述开口为圆形的凹槽的壁面上设置有两个缺口，两个缺口位置相对，两个弧形突起的外壁面间距小于或者等于所述两个缺口之间的距离，并且该间距大于所述开口为圆形的凹槽开口处的直径。
所述弧形突起关于矢状面对称分布，所述缺口关于冠状面对称分布。
所述圆柱状突起包括与所述底板相连的大圆柱以及与所述大圆柱相连的小圆柱，所述球壳与所述小圆柱相连，所述大圆柱与小圆柱的中心线重合，所述大圆柱以及小圆柱的接触面棱线采用圆角圆滑处理，所述复合材料球体顶端高出所述上椭圆柱，所述上椭圆柱与所述底板相对侧表面的外边缘采用圆角圆滑处理，该表面的内边缘(开口为圆形的凹槽开口处)采用锥形扩大处理。
所述椭圆柱体的侧面上设置有随机分布的若干个圆槽，所述椭圆柱体的中间位置设置有两个相互交叉的矩形贯通槽，两个矩形贯通槽分别沿矢状面与冠状面走行。
所述椭圆柱体、弧形L板以及复合材料垫分别采用一体成型，所述椭圆柱体以及弧形L板采用医用钛合金材质，所述复合材料垫采用超高分子量聚 乙烯材质或聚醚醚酮材质，所述弧形L板与骨面接触处以及所述椭圆柱体的侧面均设置有羟基磷灰石涂层。
上述椭圆柱体的一侧面设有沿轴向贯通的弧形凹陷，所述复合材料垫的下椭圆柱一侧面也设有沿轴向贯通的弧形凹陷，椭圆柱体侧面的弧形凹陷与复合材料垫的下椭圆柱侧面的弧形凹陷形状相同。
上述复合材料垫下椭圆柱侧面设有限位槽，所述限位槽内壁上加工有锯齿状结构，所述限位槽沿下椭圆柱正中矢状面对称分布，与弧形凹槽相贯通，所述的限位槽内安装有限位复合材料垫，限位复合材料垫的一侧面形状与大半球体形状相匹配，限位复合材料垫的另一侧面形状与复合材料垫外壁形状相匹配；所述限位复合材料垫的一侧面也加工有锯齿状结构，所述复合材料垫侧面的锯齿状结构与限位槽内壁上的锯齿状结构相匹配，限位槽与限位复合材料垫相匹配构成限位装置。
上述限位槽与限位复合材料垫的大小可以调整。
上述限位复合材料垫采用医用高分子聚乙烯或者聚醚醚酮加工而成。
本发明的有益效果体现在：
本发明所述仿生防脱位人工腰椎及椎间盘连接复合体充分考虑了腰椎的解剖特点，弧形L板用于与邻近椎体紧密结合，有效减少接触面的应力集中，满足了正常腰椎的承重功能，因球窝关节的存在，更加接近生理状态，复合材料垫与椎体部件端部凹槽的嵌入式连接不但起到缓冲作用，而且可以防止因运动过程中椎间隙增宽造成复合材料垫从椎体部件中脱出。
本发明取得的进一步的技术效果如下：
1、由钛合金铸造的带有弧形突起的近半球壳与聚乙烯构成的大半球体共同构成防脱球窝关节，不但使活动中心恰好位于椎间隙中央，避免了因活 动中心异位可能引起的潜在并发症，而且保留了椎体的旋转、侧弯、前屈、背伸及一定的缓冲功能，更加接近生理状态。
2、本发明所述弧形L板的底板的形状与腰椎终板前部形状类似，椭圆形圆顶与腰椎终板中央偏后处凹陷相吻合，圆顶上部与周边设有圆锥状齿突，使底板与终板结合更加紧密、牢固；弧形L板的侧板与椎体侧面紧密贴合，增大了接触面积，有效的避免了应力集中，底板上的大圆柱突起能够很好地承受因屈伸运动产生的横向剪切力，避免变形、折断等不良事件的发生。
3、本发明所述椎体部件侧面设有随机分布的圆槽，利于周围组织的附着及残存骨质的长入，中部的两个矩形贯通槽可以容纳较多的植入骨，从而更利于与周围组织的融合，保证了术后长期的稳定性。
4、本发明所述弧形L板与骨面接触处以及椎体部件的侧面均有羟基磷灰石涂层，更加利于与周围组织的融合，保证了活动性与稳定性。
5、本发明所述弧形L板的侧板上设有两个不在同一水平面上的螺孔，通过不同方向的螺钉植入将侧板牢固的固定于临近椎体上，降低了松动脱出的风险。
6、本发明所述的限位装置，通过改变其大小可以控制防脱球窝关节轴向旋转角度范围，避免轴线过度旋转造成小关节突及周围软组织损伤。
附图说明
图1为本发明的主视图；
图2为本发明的后视图；
图3为本发明的侧视图；
图4为本发明的俯视图；
图5为本发明的仰视图；
图6为本发明的冠状面剖视图；
图7为本发明的矢状面剖视图；
图8为弧形L板的等轴视图；
图9为复合材料垫的等轴视图；
图10为椎体部件的等轴视图；
图11为弧形L板各参数示意图；
图12为复合材料垫各参数示意图；
图13为仿生防脱位人工椎体及椎间盘连接复合体植入后的示意图；
图14为椎体部件另一实施例的等轴视图；
图15为复合材料垫另一实施例的等轴视图；
图16为限位复合材料垫的俯视图；
图17为球窝关节水平剖面图；
图中：1为椭圆柱体，2为深凹槽，3为弧形L板，4为复合材料垫，5为椭圆状圆顶，6为圆锥状齿突，7为圆柱状突起，8为弧形突起，9为近半球壳，10为侧板，11为螺孔，12为上椭圆柱，13为下椭圆柱，14为弧形凹槽，15为大半球体，16为缺口，17为上椭圆柱上面边缘，18为底板，19为底板后面棱线，20为大圆柱，21为小圆柱，22为大圆柱与小圆柱接触面棱线，23为弧形凹槽开口，24为小圆槽，25为矩形贯通槽，26为圆柱状凹槽，27为螺钉，28为弧形凹陷，29为弧形凹陷，30为限位槽，31为锯齿状结构，32为限位复合材料垫，33为锯齿状结构。
具体实施方式
下面结合附图和实施例对本发明做详细说明。
参见图1～图10及图14～图17，本发明所述仿生防脱位人工腰椎及椎间盘连接复合体，包括椎体部件、椎间盘部件及螺钉27。椎体部件由上下两面带有深凹槽2的椭圆柱体1构成，为了避免椎管内脊髓受压，椭圆柱体1的一侧面设有沿轴向贯通的弧形凹陷28，侧面设有随机分布的小圆槽24及位于中间位置的两个矩形贯通槽25，两矩形贯通槽25分别沿矢状面与冠状面走行，小圆槽24利于周围组织附着，矩形贯通槽25可以进行植骨。在沿冠状面走行的矩形贯通槽开口处上下两侧对称地设有两个圆柱状凹槽26，利于术者夹持连接复合体，便于手术操作。椎间盘部件包括两部分，即与相邻椎体连接的弧形L板3和与椎体部件相连的复合材料垫4，两者通过防脱球窝关节相连。弧形L板3由底板18、弧形侧板10与圆柱状突起7三部分组成，所述底板18呈大半椭圆形，底板后面棱线19处经圆角圆滑处理，其与相邻椎体终板接触面上设有椭圆状圆顶5及圆锥状齿突6，所述椭圆状圆顶5的中心与底板18中心重合，椭圆状圆顶5高度由中心向四周递减，圆锥状齿突6沿椭圆线均匀间隔分布于底板18上；圆柱状突起7设置于底板18与复合材料垫4相对面的椭圆中心，圆柱状突起7包括靠近底板18的大圆柱20与远离底板18的小圆柱21两部分，两者中心线重合，大圆柱与小圆柱接触面棱线22进行圆角圆滑处理，小圆柱21末端为带有两个弧形突起8的近半球壳9结构，所述弧形突起8关于矢状面对称地分布于近半球壳9两侧；所述弧形侧板10横截面呈四分之一椭圆形，位于底板18左前方边缘，并逐渐向内倾斜，弧形侧板10上设有两个不在同一水平面的螺孔11，通过螺钉27将弧形L板3牢固的固定于临近椎体侧面上。复合材料垫4由上下两个椭圆柱构成，上椭圆柱12绕其中心线一周挖有弧形凹槽14，下椭圆柱13一侧面设有沿轴向贯通的弧形凹陷29，椭圆柱体1侧面的弧形凹陷 28与复合材料垫4的下椭圆柱13侧面的弧形凹陷29形状相同，下椭圆柱13侧面设有限位槽30，限位槽30内壁上加工有锯齿状结构31，限位槽30沿下椭圆柱13正中矢状面对称分布，与弧形凹槽14相贯通，所述的限位槽30内安装有限位复合材料垫32，限位复合材料垫32的一侧面形状与大半球体15形状相匹配，限位复合材料垫32的另一侧面形状与复合材料垫外壁形状相匹；限位复合材料垫32的一侧面也加工有锯齿状结构33，所述复合材料垫32侧面的锯齿状结构33与限位槽30内壁上的锯齿状结构31相匹配，防止限位装置松动、脱出；限位槽30与限位复合材料垫32相匹配构成限位装置，限位槽30与限位复合材料垫32的大小可以调整，根据其大小不同调整防脱球窝关节轴向旋转角度范围，使得轴向旋转角度在0～90°之间变化。弧形凹槽14内壁面为大半球体15结构，弧形凹槽14外壁面前后设有两个小缺口16，所述两个小缺口16关于冠状面对称地分布于弧形凹槽14外壁面，弧形凹槽14内壁面的大半球体15顶端高出上椭圆柱12，弧形凹槽14开口处进行锥形扩大处理，既可以保证屈伸运动的活动度又可以限制过度运动。弧形凹槽14开口外直径小于近半球壳9上两弧形突起8外壁面间的距离，而弧形凹槽前后小缺口16间的距离则与两弧形突起8外壁面间的距离相等，通过此缺口两弧形突起8可以放入弧形凹槽14，进入后通过旋转，将弧形突起8远离缺口，然后将限位复合材料垫32通过限位槽31植入下椭圆柱13内，从而防止近半球壳9从弧形凹槽14中脱出，而且限制了球窝关节轴线旋转角度，既保证了该球窝关节的稳定性又避免了球窝关节过度旋转引起的小关节突及周围软组织损伤。复合材料垫4的下椭圆柱13设置于椭圆柱体1上的深凹槽2内，可以有效的避免复合材料垫从凹槽中脱出。上椭圆柱12上面边缘17进行圆角圆滑处理。该连接复合体中近半球壳 9结构与上椭圆柱的大半球体15结构相配合构成球窝关节，球窝关节保证了术后临近椎体的旋转、侧弯、前屈、背伸功能，所述螺钉27分别位于螺孔内。复合材料垫的下椭圆柱与椎体部件的深凹槽2相连接，保证了连接复合体自身的稳定性。
从图6以及图7中可以看出，弧形凹槽14就是用于安放近半球壳9的间隙。
椎体部件以及弧形L板3、螺钉27采取医用钛合金材质一体成型，弧形L板3与骨皮质接触面(如底板上面、弧形侧板内面)以及椎体部件侧面均设有羟基磷灰石涂层，更利于与周围组织的融合，保证了术后的稳定性。复合材料垫4采用超高分子聚乙烯材料或者聚醚醚酮材料一体成型，限位复合材料垫也采用医用高分子聚乙烯或者聚醚醚酮加工而成，弧形凹槽14内外两壁面以及近半球壳9结构内外两面均进行抛光处理，可以有效的降低接触面的摩擦。
参见图10，椎体部件的椭圆柱体1高26mm，椭圆长半径为23mm，短半径为15mm，上下两面凹槽(深凹槽)深为10mm，长半径为21mm，短半径为13mm，侧面两个矩形贯通槽25开口为3mm×15mm，随机分布的小圆槽24深为1mm，半径为1mm，圆柱状凹槽26深为1.5mm，半径为1.5mm。
参见图8、图11，弧形L板3的底板18厚约2mm，呈大半椭圆形，弧度为225°，椭圆长半径为23mm，短半径为18mm，底板后面棱线经半径为5mm的圆角圆滑处理。底板18上的椭圆状圆顶5中心高2mm，由中心向四周递减，圆顶长半径为15mm，短半径为10mm，中心与底板中心重合。底板18上的圆锥状齿突6高0.5mm，底半径为0.25mm(图中仅画出部分 齿状突起，仅供参考)。弧形L板3的弧形侧板10厚约2mm，呈四分之一椭圆形，高度为12mm，与底板呈70～80度夹角，螺孔11半径2mm。圆柱状突起7总高为5mm，大圆柱20高H1＝2mm，小圆柱21高H2＝3mm，大圆柱半径为10mm，小圆柱半径为7mm，两者接触面棱线进行半径为1mm的圆角圆滑处理。小圆柱末端近半球壳9厚约2mm，球壳内半径为8.1mm，球壳开口平面与球壳顶点距离D1＝5.1mm，两个弧形突起8底部平面与球壳开口平面距离D2＝3mm，弧形突起8宽W1＝6.8mm。
参见图9、图12，复合材料垫4的上椭圆柱12高3mm，下椭圆柱13高H3＝10mm，上椭圆柱长半径为23mm，短半径为15mm，下椭圆柱长半径为21mm，短半径为13mm，上椭圆柱上面边缘进行半径为2mm的圆角圆滑处理。弧形凹槽14宽为2.0mm，深H4＝9mm，大半球体15直径φ1＝16mm，球体最高点高出上椭圆柱12平面的距离D3＝2mm，弧形凹槽开口进行锥形扩大处理，锥形高为3mm，与上椭圆柱端面呈75度夹角(β)。弧形凹槽前后小缺口16深H5＝5.3mm，宽为7mm。
羟基磷灰石涂层厚度为20μm。
上述参数可根据人体腰椎大小的差异进行适当变动。
参见图13，本发明所述仿生防脱位人工腰椎及椎间盘连接复合体装配关系如下：复合材料垫4的下椭圆柱13放于椭圆柱体1的深凹槽2中，弧形L板3的圆柱状突起7末端的近半球壳9及弧形突起8结构与复合材料垫4上的弧形凹槽14构成防脱球窝关节，球窝关节各接触面进行高度抛光处理，保证关节在运动过程中较小的摩擦与磨损，螺钉27分别通过螺孔11将弧形L板3固定于邻近椎体上。弧形L板的底板18形状与终板类似，椭圆状圆顶5与椎体终板上的凹陷相吻合，圆锥状齿突6使底板18与邻近终 板结合更加牢固，弧形侧板10增加了与邻近椎体的接触面积，有效的减小了应力集中，从而满足腰椎的承重功能。椭圆柱体1设有矩形贯通槽25及随机分布小圆槽24，更利于周围组织的附着、生长，保证了术后的长期稳定性。防脱球窝关节不但保证了植入后椎间盘部位的稳定性，防止假体脱出，限制了假体轴向旋转角度，而且保留了椎体间的旋转、侧弯、前屈、背伸功能，更加符合人体生理状态。
总之，本发明所述仿生防脱位人工腰椎及椎间盘连接复合体，包括椎体部件、椎间盘部件及螺钉。椎体部件由上下两面带有深凹槽2的椭圆柱体1构成，侧面设有随机分布的小圆槽24及中间位置两个矩形贯通槽25。椎间盘部件包括两部分，即与相邻椎体连接的弧形L板3和与椭圆柱体1相连的复合材料垫4，弧形L板3由底板18、弧形侧板10与圆柱状突起7构成，底板18上设有椭圆状圆顶5及圆锥状齿突6，弧形侧板10上设有两个不在同一平面的螺孔11，圆柱状突起7末端为带有两个弧形突起8的近半球壳9结构；复合材料垫4由上下两个椭圆柱构成，下椭圆柱13设置于椭圆柱体1深凹槽内，上椭圆柱12绕其中心线一周挖有弧形凹槽14，凹槽内面为大半球体15结构，近半球壳结构与上椭圆柱的大半球体结构相配合构成球窝关节，关节面进行抛光处理，与骨面接触处有羟基磷灰石涂层。本发明不但可以替代腰椎手术中取掉的椎体及邻近的椎间盘，而且保留了椎间盘的旋转、屈伸及一定的缓冲功能，既保证了术后的稳定性，又保留了腰椎的活动性，在仿生学上更接近人体生理状态。

Claims (14)

  1. 一种仿生防脱位人工腰椎及椎间盘连接复合体，其特征在于：该人工腰椎及椎间盘连接复合体包括椎体部件以及设置于椎体部件两端的椎间盘部件，所述椎间盘部件包括弧形L板(3)以及复合材料垫(4)，所述弧形L板(3)包括分别与腰椎椎体的终板以及侧面形状相应的底板(18)以及侧板(10)，所述侧板(10)设置于所述底板(18)上，所述底板(18)与复合材料垫(4)之间通过球窝关节相连，所述椎体部件包括椭圆柱体(1)，椭圆柱体(1)的两个端面上开设有凹槽(2)，两个椎间盘部件的复合材料垫(4)分别嵌入在椭圆柱体(1)的对应端面上的凹槽(2)内。
  2. 根据权利要求1所述一种仿生防脱位人工腰椎及椎间盘连接复合体，其特征在于：所述底板(18)的边缘由椭圆弧段以及与该椭圆弧段的两端圆滑过渡连接的M字型曲线段组成，所述椭圆弧段以对应椭圆的短轴对称，所述侧板(10)设置于所述底板(18)边缘的椭圆弧段上，所述侧板(10)向内倾斜并与所述底板(18)呈70～80度夹角，所述侧板(10)上设置有螺孔(11)。
  3. 根据权利要求2所述一种仿生防脱位人工腰椎及椎间盘连接复合体，其特征在于：所述底板(10)上设置有椭圆状圆顶(5)以及圆锥状齿突(6)，所述椭圆状圆顶(5)以及圆锥状齿突(6)与所述侧板(10)位于所述底板(18)的同一侧表面，椭圆状圆顶(5)的中心与所述底板(18)中心重合，椭圆状圆顶(5)高度由中心向四周递减，圆锥状齿突(6)沿椭圆线间隔分布于所述底板(18)上。
  4. 根据权利要求2所述一种仿生防脱位人工腰椎及椎间盘连接复合体，其特征在于：所述螺孔(11)为两个，两个螺孔(11)不在同一水平面上。
  5. 根据权利要求1所述一种仿生防脱位人工腰椎及椎间盘连接复合体，其特征在于：所述复合材料垫(4)包括嵌入在所述椭圆柱体(1)的对应端面上的凹槽(2)内的下椭圆柱(13)、设置于该凹槽(2)开口位置处的与所述下椭圆柱(13)相连的上椭圆柱(12)以及用于作为球窝关节关节头的复合材料球体，所述上椭圆柱(12)上设置有开口为圆形的弧形凹槽(14)，该开口为圆形的弧形凹槽(14)延伸至下椭圆柱(13)内，所述复合材料球体设置于所述开口为圆形的弧形凹槽(14)内，所述复合材料球体与所述上椭圆柱(12)之间留有间隙，所述间隙内设置有与所述复合材料球体配合的用于作为球窝关节关节窝的球壳，所述球壳与设置于所述底板(18)上的圆柱状突起(7)相连。
  6. 根据权利要求5所述一种仿生防脱位人工腰椎及椎间盘连接复合体，其特征在于：所述球壳的开口边缘处设置有两个弧形突起(8)，所述两个弧形突起(8)位置相对，所述开口为圆形的凹槽的壁面上设置有两个缺口(16)，两个缺口(16)位置相对，两个弧形突起(8)的外壁面间距小于或者等于所述两个缺口(16)之间的距离，并且大于所述开口为圆形的凹槽开口处的直径。
  7. 根据权利要求6所述一种仿生防脱位人工腰椎及椎间盘连接复合体，其特征在于：所述弧形突起(8)关于矢状面对称分布，所述缺口(16)关于冠状面对称分布。
  8. 根据权利要求5所述一种仿生防脱位人工腰椎及椎间盘连接复合体，其特征在于：所述圆柱状突起(7)包括与所述底板(18)相连的大圆柱(20)以及与所述大圆柱(20)相连的小圆柱(21)，所述球壳与所述小圆柱(21)相连，所述大圆柱(20)与小圆柱(21)的中心线重合，所述大圆柱(20) 以及小圆柱(21)的接触面棱线采用圆角圆滑处理，所述复合材料球体顶端高出所述上椭圆柱(12)，所述上椭圆柱(12)与所述底板(18)相对侧表面的外边缘采用圆角圆滑处理，该表面的内边缘采用锥形扩大处理。
  9. 根据权利要求1所述一种仿生防脱位人工腰椎及椎间盘连接复合体，其特征在于：所述椭圆柱体(1)的侧面上设置有随机分布的若干个圆槽，所述椭圆柱体(1)的中间位置设置有两个相互交叉的矩形贯通槽(25)，两个矩形贯通槽(25)分别沿矢状面与冠状面走行。
  10. 根据权利要求1所述一种仿生防脱位人工腰椎及椎间盘连接复合体，其特征在于：所述椭圆柱体(1)、弧形L板(3)以及复合材料垫(4)分别采用一体成型，所述椭圆柱体(1)以及弧形L板(3)采用医用钛合金材质，所述复合材料垫(4)采用超高分子量聚乙烯材质或聚醚醚酮材质，所述弧形L板(3)与骨面接触处以及所述椭圆柱体(1)的侧面均设置有羟基磷灰石涂层。
  11. 根据权利要求1所述一种仿生防脱位人工腰椎及椎间盘连接复合体，其特征在于：所述椭圆柱体(1)的一侧面设有沿轴向贯通的弧形凹陷(28)，所述复合材料垫(4)的下椭圆柱(13)一侧面也设有沿轴向贯通的弧形凹陷(29)，椭圆柱体(1)侧面的弧形凹陷(28)与复合材料垫(4)的下椭圆柱(13)侧面的弧形凹陷(29)形状相同。
  12. 根据权利要求1所述一种仿生防脱位人工腰椎及椎间盘连接复合体，其特征在于：所述复合材料垫(4)下椭圆柱(13)侧面设有限位槽(30)，所述限位槽(30)内壁上加工有锯齿状结构(31)，所述限位槽(30)沿下椭圆柱(13)正中矢状面对称分布，与弧形凹槽(14)相贯通，所述的限位槽(30)内安装有限位复合材料垫(32)，限位复合材料垫(32)的一侧面 形状与大半球体(15)形状相匹配，限位复合材料垫(32)的另一侧面形状与复合材料垫外壁形状相匹配；所述限位复合材料垫(32)的一侧面也加工有锯齿状结构(33)，所述复合材料垫(32)侧面的锯齿状结构(33)与限位槽(30)内壁上的锯齿状结构(31)相匹配，限位槽(30)与限位复合材料垫(32)相匹配构成限位装置。
  13. 根据权利要求12所述一种仿生防脱位人工腰椎及椎间盘连接复合体，其特征在于：所述限位槽(30)与限位复合材料垫(32)的大小可以调整。
  14. 根据权利要求12所述一种仿生防脱位人工腰椎及椎间盘连接复合体，其特征在于：所述限位复合材料垫(32)采用医用高分子聚乙烯或者聚醚醚酮加工而成。
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