CN110179570B - A design method of a gradient porous cervical interbody cage - Google Patents

A design method of a gradient porous cervical interbody cage Download PDF

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CN110179570B
CN110179570B CN201910512299.1A CN201910512299A CN110179570B CN 110179570 B CN110179570 B CN 110179570B CN 201910512299 A CN201910512299 A CN 201910512299A CN 110179570 B CN110179570 B CN 110179570B
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porous structure
point set
curve
porous
porosity
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CN110179570A (en
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李祥
陈华江
高芮宁
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Shanghai Jiao Tong University
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772—Apertures or holes, e.g. of circular cross section
    • A61F2002/30784—Plurality of holes
    • 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
    • A61F2002/30818—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves castellated or crenellated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3093—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30943—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using mathematical models

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  • Life Sciences & Earth Sciences (AREA)
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Abstract

本发明公开了一种梯度多孔颈椎椎间融合器的设计方法，涉及骨科植入物领域，本发明设计的梯度多孔颈椎椎间融合器包括多孔结构、第一齿结构、第二齿结构、植骨窗；所述多孔结构为多孔的六面体构件，所述多孔结构的上表面和前表面为圆弧面，所述多孔结构的其余表面均为倾斜的平面，所述多孔结构的各个表面之间平滑过渡；所述第一齿结构设置在所述多孔结构的上表面，所述第二齿结构设置在所述多孔结构的下表面；所述植骨窗为联通所述多孔结构的上表面和下表面的通孔；本发明设计的颈椎椎间融合器，具有梯度分布的孔隙结构，能有效促进椎间融合器与椎骨融合为一体，减少应力集中，兼具良好的生物力学性能与生物相容性的优点。

Figure 201910512299

The invention discloses a design method of a gradient porous cervical intervertebral cage, which relates to the field of orthopedic implants. The gradient porous cervical intervertebral cage designed by the invention includes a porous structure, a first tooth structure, a second tooth structure, an implant Bone window; the porous structure is a porous hexahedral member, the upper surface and the front surface of the porous structure are arc surfaces, the remaining surfaces of the porous structure are inclined planes, and the surfaces of the porous structure are between smooth transition; the first tooth structure is arranged on the upper surface of the porous structure, and the second tooth structure is arranged on the lower surface of the porous structure; the bone graft window communicates the upper surface of the porous structure and the The through hole on the lower surface; the cervical intervertebral fusion cage designed by the present invention has a pore structure with gradient distribution, which can effectively promote the fusion of the intervertebral cage and the vertebrae into one, reduce stress concentration, and have both good biomechanical performance and biological compatibility. Capacitive advantage.

Figure 201910512299

Description

Design method of gradient porous cervical vertebra interbody fusion cage
Technical Field
The invention relates to the field of orthopedic implants, in particular to a design method of a gradient porous cervical vertebra interbody fusion cage.
Background
At present, the cervical vertebra degeneration accounts for more than 50% of middle-aged people. Common cervical degeneration includes prolapse of cervical intervertebral disc, osteophyte formation, and ligament hypertrophy. Cervical degeneration often leads to neurological dysfunction, and in severe cases, requires surgery for treatment. Anterior cervical discectomy decompression fusion is a common operation for treating cervical degeneration, and the purpose of the operation is to obtain bony fusion. By using the cervical vertebra interbody fusion cage, the risk of falling and collapse of the transplanted bone in autologous bone fusion can be avoided, the height of the cervical vertebra intervertebral disc is restored, pain is relieved, symptoms such as nerve compression and the like are relieved, the growth of bones is promoted, and the stability of the vertebral body is enhanced.
The application of the porous structure to the design of the interbody cage gives the interbody cage many advantages, mainly expressed as: the porous structure reduces the rigidity of the material of the fusion cage and avoids the stress shielding effect; but also contributes to the bone tissue to grow inwards into pores, and the bone tissue and the fusion cage form a tightly combined whole to enhance the long-term stability of the fusion cage. The good bone gap distribution can not only ensure the requirements of the biomechanical property of the interbody fusion cage, but also be beneficial to the bone conduction and bone induction, and is an ideal interbody fusion cage structure.
Before the application date, the intervertebral fusion cage used clinically generally has no pore structure and no pore structure with gradient distribution, so that bone cells cannot grow into the fusion cage, namely the intervertebral fusion cage cannot be fused with vertebrae into a whole, and the long-term stability of the intervertebral fusion cage is poor; in a few of the disclosed designs of the multi-hole interbody fusion cage, the used pore structures are obtained by CAD software modeling, and a large number of sharp corners exist inside the multi-hole interbody fusion cage, so that the stress concentration phenomenon is very obvious, the strength and the rigidity are weakened, and the fatigue resistance performance is very weak.
Therefore, the technical personnel in the field are dedicated to develop a design method of the gradient porous cervical vertebra interbody fusion cage, and the design method adopts a pore structure with gradient distribution to promote the interbody fusion cage and vertebrae to be fused into a whole, has small stress concentration phenomenon and has good biomechanical property and biocompatibility.
Disclosure of Invention
In view of the above-mentioned defects of the prior art, the technical problems to be solved by the present invention are that the existing porous interbody fusion cage has low stress concentration, strength, rigidity and fatigue resistance, and low biomechanical properties and biocompatibility.
In order to achieve the aim, the invention discloses a design method of a gradient porous cervical vertebra interbody fusion cage, which comprises a porous structure, a first tooth structure, a second tooth structure and a bone grafting window; the porous structure is a porous hexahedral member, the upper surface and the front surface of the porous structure are arc surfaces, the rest surfaces of the porous structure are inclined planes, the surfaces of the porous structure are in smooth transition, and the transition between the surfaces of the porous structure conforms to the human anatomy design; the first tooth structure is arranged on the upper surface of the porous structure, and the second tooth structure is arranged on the lower surface of the porous structure; the bone grafting window is a through hole communicated with the upper surface and the lower surface of the porous structure, the bone grafting window is arranged in the middle of the upper surface and the lower surface of the porous structure, the porosity of the porous structure close to the bone grafting window is high, the porosity of the porous structure far away from the bone grafting window is low, the porosity of the porous structure is uniformly distributed in the height direction of the porous structure, the height direction of the porous structure is perpendicular to the upper surface and the lower surface of the porous structure, the porosity of the porous structure is in gradient arrangement, the gradient ascending direction of the porosity of the porous structure is perpendicular to the direction of the outer edge line of the gradient porous cervical vertebra fusion device, a groove with a threaded hole is arranged at the front part of the porous structure, the pore diameter and the rod diameter of the pore of the porous structure are in gradient distribution, and the pore diameter of the pore of the porous structure is in direct proportion to the porosity of the porous structure, the rod diameter of the gap of the porous structure is inversely proportional to the porosity of the porous structure, the pore diameter range of the gap of the porous structure is 150-800 microns, the rod diameter range of the gap of the porous structure is 100-600 microns, the gap of the porous structure is obtained by adopting a pore-forming unit, the pore-forming unit is obtained by continuously biasing and closing the three-period minimum curved surface on a two-dimensional plane, the period of the three-period minimum curved surface is 0.5-2 mm, the size of the length, the width and the height of a cube bounding box of the pore-forming unit is 0.5-2 mm, and the period of the three-period minimum curved surface is consistent with the size of the length, the width and the height of the cube bounding box of the pore-forming unit, and the pore-forming method is characterized by comprising the following steps of:
step 1: initially constructing an integral structure;
designing a rough drawing of an outer edge line of the porous structure according to the axial two-dimensional size of the porous structure by using three-dimensional modeling software, and inwards offsetting the outer edge line of the porous structure by 2-4 mm to obtain a rough drawing of an inner offset line, wherein the middle area of the outer edge line and the inner offset line is a design area of the porous structure, and the inner offset line is internally provided with the bone grafting window;
step 2: constructing a porosity distribution hierarchy of the porous structure;
in a closed area defined by the outer edge line and the inner bias line of the porous structure, the outer edge line of the porous structure is biased inwards at equal intervals, the range of the bias distance is 0.5-1 mm, 6 curves including the inner bias line and the outer edge line are obtained, and the closed curves from inside to outside are respectively named as a curve 1, a curve 2, a curve 3, a curve 4, a curve 5 and a curve 6;
and step 3: constructing coordinate data;
respectively taking data points on the curves 1 to 6 at equal intervals, selecting 10-30 points on each curve, wherein a point set on the curve 1 is called a point set 1, a point set on the curve 2 is called a point set 2, a point set on the curve 3 is called a point set 3, a point set on the curve 4 is called a point set 4, a point set on the curve 5 is called a point set 5, a point set on the curve 6 is called a point set 6, and respectively deriving coordinates of all the point sets to serve as data files;
and 4, step 4: designing a gradient value;
each of the curves 1 to 6 in the step 2 represents a porosity value, and the point set 1 to the point set 6 in the step 3 are used to replace the curves 1 to 6 to control the porosity distribution of the porous structure; the porosity of the curve 1 is set to 80%, the porosity of the curve 2 is set to 70%, the porosity of the curve 3 is set to 60%, the porosity of the curve 4 is set to 50%, the porosity of the curve 5 is set to 40%, and the porosity of the curve 6 is set to 30%, under which setting a gradient decreasing distribution of the porosity of the porous structure from inside to outside is achieved;
and 5: designing a control equation;
selecting a Gyoid unit in a three-period minimum curved surface unit as a pore-forming unit of the porous structure; the Gyoid unit is formed by a Gyoid surface, and the basic equation of the Gyoid surface with the period of 1 can be described as follows:
cos(2πx)sin(2πy)+cos(2πy)sin(2πz)+cos(2πz)sin(2πx)＝0；
defining the Gyoid curved surface as an interface of a solid part and a pore part of the porous structure,
the solid part of the porous structure is:
cos(2πx)sin(2πy)+cos(2πy)sin(2πz)+cos(2πz)sin(2πx)＜0；
the pore portion of the porous structure is:
cos(2πx)sin(2πy)+cos(2πy)sin(2πz)+cos(2πz)sin(2πx)＞0；
the offset design of the three-cycle infinitesimal curved surface unit moves the Gyoid curved surface to two sides by changing the basic equation of the Gyoid curved surface and the numerical values on the right sides of the solid part of the porous structure and the pore inequality, wherein the basic equation of the Gyoid curved surface and the numerical values on the right sides of the solid part of the porous structure and the pore inequality are called offset constants; according to the step 4, the porosities of the point sets 1 to 6 are respectively 80%, 70%, 60%, 50%, 40% and 30%, so that the bias constants are respectively 0.91,0.61,0.30,0, -0.30 and-0.61, and the control equation of the point set 1 is:
Figure GDA0003069793410000031
the control equation for calculating the point set 2 is:
Figure GDA0003069793410000032
the control equation for counting the point set 3 is:
Figure GDA0003069793410000033
the control equation for calculating the point set 4 is:
Figure GDA0003069793410000034
the control equation for counting the point set 5 is:
Figure GDA0003069793410000035
the governing equation for counting the point set 6 is:
Figure GDA0003069793410000036
step 6: establishing a global structural equation;
according to the above-mentioned step 3 to the above-mentioned step 5,
all coordinates of the point set 1 are counted as (x)1i,y1i) Wherein i is 1,2,3 … N, N is the number of points in the point set 1,
coordinate notation (x) for said set of points 22i,y2i) Wherein i is 1,2,3 … N, N is the number of points in the point set 2,
coordinate notation (x) for the set of points 33i,y3i) Wherein i is 1,2,3 … N, N is the number of points in the point set 3,
the coordinates of the set of points 4 are counted as (x)4i,y4i) Wherein i is 1,2,3 … N, N is the number of points in the point set 4,
the coordinates of the set of points 5 are counted as (x)5i,y5i) Wherein i is 1,2,3 … N, N is the number of points in the point set 5,
the coordinates of the set of points 6 are counted as (x)6i,y6i) Wherein i is 1,2,3 … N, N is the number of points in the point set 6,
and calculating a global structure equation as follows based on an inverse distance weighted interpolation algorithm of the space points:
Figure GDA0003069793410000041
in the formula, λjIn order to be a weighting factor, the weighting factor,
Figure GDA0003069793410000042
Figure GDA0003069793410000043
wherein p is 2-4; epsilon is a small constant which prevents introduction of a denominator of 0, 0.0001 to 0.001,
Figure GDA0003069793410000044
determined for said step 5
Figure GDA0003069793410000045
Taking the three-period minimum curved surface unit curved surface
Figure GDA0003069793410000046
Is the boundary between the solid portion of the porous structure and the pore portion of the porous structure, and
Figure GDA0003069793410000047
is a solid part of the porous structure,
Figure GDA0003069793410000048
is a pore portion of the porous structure;
and 7: preliminarily constructing the porous structure;
writing the porous structure modeling program based on the three-cycle minimal curved surface unit according to the global structure equation, defining a calculation domain, realizing the porous structure modeling program based on the global structure equation and a Marching cube algorithm, and preliminarily constructing the porous structure by using three-dimensional modeling software;
and 8: further constructing the porous structure;
preliminarily perfecting a macroscopic model of the porous structure by using the three-dimensional modeling software, wherein the upper surface and the front surface of the porous structure are arc surfaces, and the rest surfaces of the porous structure are planes with a certain inclination angle; further constructing the porous structure by intersecting the macroscopic model of the porous structure with the step 6;
and step 9: building up the first tooth structure and the second tooth structure;
establishing the first tooth structure and the second tooth structure by using the three-dimensional modeling software, wherein the tooth heights of the first tooth structure and the second tooth structure are both 0.5-0.8 mm, the tooth rows of the first tooth structure and the second tooth structure are both 5-8, the tooth widths of two rows of teeth close to the front surface of the porous structure and one row of teeth close to the rear surface of the porous structure are consistent with the position widths of two side edges of the macroscopic model of the porous structure constructed in the step 8, and the tooth widths of the rest first tooth structure and the rest second tooth structure are both 2-3 mm;
step 10: constructing the groove with the threaded hole;
constructing the groove with the threaded hole on the front surface of the porous structure by using the three-dimensional modeling software;
step 11: performing Boolean operation;
and combining the porous structure obtained in the step 8, the first tooth structure and the second tooth structure obtained in the step 9, and the groove with the threaded hole obtained in the step 10 into a whole through Boolean operation.
Compared with the prior art, the invention has the following beneficial effects:
1. the intervertebral fusion cage is designed into a porous structure, and the bone grafting window is reserved, so that the stress shielding phenomenon is avoided, the rapid fusion of bones is promoted, and the stability of long-term treatment is improved;
2. the porous structure is designed into a gradient porous structure, the porosity of the porous structure close to the bone grafting window is high, the porosity of the outer edge area is low, and the gradient rising direction of the porosity is vertical to the direction of the outer edge line. The design of the gradient porous structure can simultaneously meet the requirements of biological and mechanical properties. The high porosity area in the center is beneficial to migration, proliferation and differentiation of bone cells, the low porosity area at the edge ensures enough bearing requirements, and the bone grafting window which is communicated up and down promotes rapid fusion of bones.
3. The invention uses the pore-forming unit based on the curved surface structure, adopts the three-period extremely-small curved surface pore-forming unit, has continuous inner pore passages and no sharp corner, and reduces stress concentration, thereby improving the strength and the fatigue resistance.
Drawings
FIG. 1 is a schematic view of a gradient multi-hole intervertebral cage according to a preferred embodiment of the present invention;
FIG. 2 is a schematic top view of a gradient multi-hole intervertebral cage according to a preferred embodiment of the invention;
FIG. 3 is a schematic cross-sectional view of a gradient multi-hole intervertebral cage according to a preferred embodiment of the invention;
FIG. 4 is a schematic view of a spacing block of the gradient multi-hole intervertebral cage according to a preferred embodiment of the present invention;
FIG. 5 is a schematic two-dimensional outline of an outer edge line and an inner edge line in accordance with a preferred embodiment of the present invention;
FIG. 6 is a schematic diagram of the outer edge line of a preferred embodiment of the present invention after being biased inward by an equidistant curve;
FIG. 7 is a schematic diagram of a set of equidistant points along the outer edge line and its offset curve in accordance with a preferred embodiment of the present invention;
FIG. 8 is a schematic view of a contour model of a porous structure portion according to a preferred embodiment of the present invention;
FIG. 9 is a schematic view of a porous structure with edge features in accordance with a preferred embodiment of the present invention;
FIG. 10 is a schematic view of a first and second tooth arrangement of the gradient porous cervical interbody cage of the preferred embodiment of the present invention;
FIG. 11 is a schematic view of a threaded recess in accordance with a preferred embodiment of the present invention;
FIG. 12 is a schematic view of a gradient multi-hole intervertebral cage according to another preferred embodiment of the present invention.
Detailed Description
The technical contents of the preferred embodiments of the present invention will be more clearly and easily understood by referring to the drawings attached to the specification. The present invention may be embodied in many different forms of embodiments and the scope of the invention is not limited to the embodiments set forth herein.
In the drawings, structurally identical elements are represented by like reference numerals, and structurally or functionally similar elements are represented by like reference numerals throughout the several views. The size and thickness of each component shown in the drawings are arbitrarily illustrated, and the present invention is not limited to the size and thickness of each component. The thickness of the components may be exaggerated where appropriate in the figures to improve clarity.
Example 1:
in this embodiment, the height of the cervical intervertebral space of the patient is 6mm, so the height of the intervertebral fusion device is 6mm, and the intervertebral fusion device can be customized according to the characteristics of the intervertebral space of the patient.
As shown in fig. 1, the gradient porous cervical interbody fusion cage provided by this embodiment includes a porous structure 1, a first tooth structure 2, a second tooth structure 3, and a bone grafting window 4; the porous structure 1 is a porous hexahedral member, the upper surface and the front surface of the porous structure 1 are arc surfaces, the rest surfaces of the porous structure 1 are inclined planes, the surfaces of the porous structure 1 are in smooth transition, and the transition between the surfaces of the porous structure 1 conforms to the human anatomy design; the first tooth structure 2 is arranged on the upper surface of the porous structure 1, and the second tooth structure 3 is arranged on the lower surface of the porous structure 1; as shown in fig. 2, the bone grafting window 4 is a through hole communicating the upper surface and the lower surface of the porous structure 1, the bone grafting window 4 is arranged in the middle of the upper surface and the lower surface of the porous structure 1, the porosity of the porous structure 1 near the bone grafting window 4 region is high, the porosity of the porous structure 1 far from the bone grafting window 4 region is low, in this embodiment, the porosity of the porous structure near the bone grafting window region is 80%, the porosity of the porous structure edge region is 30%, the dimension a between the front surface and the rear surface of the gradient porous cervical interbody fusion cage is 10mm, and the dimension b between the left surface and the right surface of the gradient porous cervical interbody fusion cage is 12 mm. As shown in fig. 3, the porosity of the porous structure 1 is uniformly distributed in the height direction of the porous structure 1, the height direction of the porous structure 1 is a direction perpendicular to the upper surface and the lower surface of the porous structure 1, and the dimension e between the upper surface and the lower surface of the gradient porous cervical interbody cage is 6 mm.
The porosity of the porous structure 1 is arranged in a gradient manner, and the gradient rising direction of the porosity of the porous structure 1 is vertical to the direction of the outer edge line of the gradient porous cervical vertebra interbody fusion cage.
The front part of the porous structure 1 is provided with a groove with a threaded hole.
The pores of the porous structure 1 are obtained by using pore-forming units, as shown in fig. 4, the pore-forming unit structure adopted in the present example is a Gyoid unit in a three-cycle minimum curved surface unit, wherein the size of a bounding box of the pore-forming unit is 1mm, that is, the length f, the width g and the height h of the unit structure are all 1 mm. The porosity of the unit is 30-90%, and the sizes of the unit bounding boxes with different porosities are all 1 mm.
The pore diameter and the rod diameter of the pores of the porous structure 1 are both in gradient distribution, the pore diameter of the pores of the porous structure 1 is in direct proportion to the porosity of the porous structure 1, the rod diameter of the pores of the porous structure 1 is in inverse proportion to the porosity of the porous structure 1, the pore diameter range of the pores of the porous structure 1 is 150-800 micrometers, and the rod diameter range of the pores of the porous structure 1 is 100-600 micrometers.
The first tooth structure 2 and the second tooth structure 3 are provided with 7 rows of teeth, the tooth height k is 0.5-0.8 mm, and the tooth width m is 2-3 mm.
The design method of the gradient porous cervical interbody fusion cage comprises the following steps:
step 1: initially constructing an integral structure;
as shown in fig. 5, a sketch of an outer edge line of the porous structure 1 is designed according to the axial two-dimensional size of the porous structure 1 by using three-dimensional modeling software, the outer edge line of the porous structure 1 is inwardly offset by 3.5mm to design an inner offset line sketch, the middle area between the outer edge line and the inner offset line of the porous structure 1 is a design area of the porous structure 1, and a bone grafting window 4 is arranged inside the inner offset line;
step 2: constructing a porosity distribution hierarchy of the porous structure 1;
as shown in fig. 6, in a closed region surrounded by an outer edge line and an inner offset line of the porous structure 1, the outer edge line of the porous structure 1 is offset inwards by 5 curves at equal intervals, the offset distance is 0.7mm according to the inner offset distance of 3.5mm, and the closed curves from inside to outside are respectively named as curve 1, curve 2, curve 3, curve 4, curve 5 and curve 6;
and step 3: constructing coordinate data;
as shown in fig. 7, data points n are respectively obtained on curves 1 to 6 at equal intervals, 20 points are selected on each curve, a point set on the curve 1 is called a point set 1, and so on, and coordinates of all the point sets are respectively exported to be used as data files;
and 4, step 4: designing a gradient value;
each curve from the curve 1 to the curve 6 in the step 2 represents a porosity value, and the point set 1 to the point set 6 in the step 3 are used for replacing the curves 1 to 6 to control the porosity distribution of the porous structure 1; in the setting in which curve 1 is set to 80%, the porosity of curve 2 is also set to 70%, the porosity of curve 3 is set to 60%, the porosity of curve 4 is set to 50%, the porosity of curve 5 is set to 40%, and the porosity of curve 6 is set to 30%, a gradient decreasing distribution of the porosity of the porous structure 1 from the inside to the outside is achieved;
and 5: designing a control equation;
selecting a Gyoid unit in a three-period minimum curved surface unit as a pore-forming unit of the porous structure 1; the Gyoid unit is formed by a Gyoid surface, and the basic equation of the Gyoid surface with the period of 1 can be described as follows:
cos(2πx)sin(2πy)+cos(2πy)sin(2πz)+cos(2πz)sin(2πx)＝0；
the Gyoid curved surface is defined as the interface between the solid part and the pore part of the porous structure 1,
the solid part of the porous structure 1 is:
cos(2πx)sin(2πy)+cos(2πy)sin(2πz)+cos(2πz)sin(2πx)＜0；
the pore portion of the porous structure 1 is:
cos(2πx)sin(2πy)+cos(2πy)sin(2πz)+cos(2πz)sin(2πx)＞0；
the offset design of the three-cycle minimal curved surface unit moves the Gyoid curved surface to two sides by changing the basic equation of the Gyoid curved surface and the numerical values on the right sides of the solid part and the pore inequality of the porous structure 1, wherein the basic equation of the Gyoid curved surface and the numerical values on the right sides of the solid part and the pore inequality of the porous structure 1 are called offset constants; according to step 4, the porosities corresponding to the point set 1 to the point set 6 are respectively 80%, 70%, 60%, 50%, 40%, and 30%, so that the bias constants are respectively 0.91,0.61,0.30,0, -0.30, -0.61, and the control equation of the point set 1 is:
Figure GDA0003069793410000071
the control equation for calculating the point set 2 is:
Figure GDA0003069793410000072
the control equation for counting the point set 3 is:
Figure GDA0003069793410000073
the control equation for calculating the point set 4 is:
Figure GDA0003069793410000074
the control equation for counting the point set 5 is:
Figure GDA0003069793410000075
the governing equation for counting the point set 6 is:
Figure GDA0003069793410000081
step 6: establishing a global structural equation;
according to the steps 3 to 5,
all coordinates of point set 1 are counted as (x)1i,y1i) Wherein i is 1,2,3 … N, N is the number of points in the point set 1,
coordinate of point set 2 is calculated as (x)2i,y2i) Wherein i is 1,2,3 … N, N is the number of points in the point set 2,
coordinate of point set 3 is calculated as (x)3i,y3i) Wherein i is 1,2,3 … N, N is the number of points in the point set 3,
coordinate of point set 4 is calculated as (x)4i,y4i) Wherein i is 1,2,3 … N, N is the number of points in the point set 4,
coordinate of point set 5 is calculated as (x)5i,y5i) Wherein i is 1,2,3 … N, N is the number of points in the point set 5,
coordinate of point set 6 is calculated as (x)6i,y6i) Wherein i is 1,2,3 … N, N is the number of points in the point set 6,
and calculating a global structure equation as follows based on an inverse distance weighted interpolation algorithm of the space points:
Figure GDA0003069793410000082
in the formula, λjIn order to be a weighting factor, the weighting factor,
Figure GDA0003069793410000083
Figure GDA0003069793410000084
wherein p is 2-4; epsilon is a small constant which prevents introduction of a denominator of 0, 0.0001 to 0.001,
Figure GDA0003069793410000085
determined for step 5
Figure GDA0003069793410000086
Taking three-cycle minimum curved surface unit curved surface
Figure GDA0003069793410000087
Is a boundary between a solid portion of the porous structure 1 and a pore portion of the porous structure 1, and
Figure GDA0003069793410000088
is a solid part of the porous structure 1,
Figure GDA0003069793410000089
is a pore portion of the porous structure 1;
and 7: preliminarily constructing a porous structure 1;
writing a porous structure 1 modeling program based on three-cycle minimum curved surface units according to a global structure equation, defining a calculation domain, realizing the program based on the global structure equation and a Marching Cubes algorithm, and preliminarily constructing a porous structure 1 by using three-dimensional modeling software; directly outputting the STL model through a modeling program;
and 8: further constructing a porous structure 1;
as shown in fig. 8, a macroscopic model of the porous structure 1 is preliminarily perfected by using three-dimensional modeling software, so that the upper surface and the front surface of the porous structure 1 are arc surfaces, and the surfaces of the rest of the porous structures 1 are planes with a certain inclination angle; the inner through hole is used as a bone grafting window 4; as shown in fig. 9, the porous structure 1 is further constructed by intersecting the macroscopic model of the porous structure 1 with step 6;
and step 9: constructing a first tooth structure 2 and a second tooth structure 3;
as shown in fig. 10, a first tooth structure 2 and a second tooth structure 3 are established by using three-dimensional modeling software, the tooth height is 0.5-0.8 mm, the number of rows is 7, in the first tooth structure 2 and the second tooth structure 3, the tooth widths of two rows of teeth close to the front surface of the porous structure 1 and one row of teeth close to the rear surface of the porous structure 1 are consistent with the position widths of two side edges of the macroscopic model of the porous structure 1 obtained in step 8, and the tooth widths of the rest first tooth structures and the rest second tooth structures are 2-3 mm;
step 10: constructing a groove with a threaded hole;
as shown in fig. 11, a groove with a threaded hole is constructed using three-dimensional modeling software;
step 11: performing Boolean operation;
and (3) combining the porous structure 1 obtained in the step (8), the first tooth structure 2 and the second tooth structure 3 obtained in the step (9) and the groove with the threaded hole obtained in the step (10) into a whole through Boolean operation.
Example 2:
in this embodiment, the height of the cervical intervertebral space of the patient is 4mm, so the height of the intervertebral fusion cage is 4mm, and the intervertebral fusion cage can be customized according to the characteristics of the intervertebral space of the patient.
Based on example 1, the porosity of the porous structure in the area close to the bone graft window is 90%, the porosity of the porous structure in the edge area is 20%, the dimension a between the front surface and the rear surface of the gradient porous cervical interbody cage is 16mm, and the dimension b between the left surface and the right surface of the gradient porous cervical interbody cage is 18 mm.
The design method of the gradient porous cervical interbody fusion cage of the embodiment is modified as follows on the basis of the embodiment 1: in the step 5, a D unit or a P unit or an IWP unit in the three-period minimum curved surface unit is selected to replace a Gyoid unit to serve as a pore-forming unit of the porous structure 1, and the curved surface equation of the three-period minimum curved surface unit is correspondingly changed when the control equation is constructed.
Example 3:
based on the embodiment 1, as shown in fig. 12, the gradient porous cervical interbody fusion cage is changed into a structure without the bone grafting window 4.
The foregoing detailed description of the preferred embodiments of the invention has been presented. It should be understood that numerous modifications and variations could be devised by those skilled in the art in light of the present teachings without departing from the inventive concepts. Therefore, the technical solutions available to those skilled in the art through logic analysis, reasoning and limited experiments based on the prior art according to the concept of the present invention should be within the scope of protection defined by the claims.

Claims (1)

1. A design method of a gradient porous cervical vertebra interbody fusion cage comprises a porous structure, a first tooth structure, a second tooth structure and a bone grafting window; the porous structure is a porous hexahedral member, the upper surface and the front surface of the porous structure are arc surfaces, the rest surfaces of the porous structure are inclined planes, the surfaces of the porous structure are in smooth transition, and the transition between the surfaces of the porous structure conforms to the human anatomy design; the first tooth structure is arranged on the upper surface of the porous structure, and the second tooth structure is arranged on the lower surface of the porous structure; the bone grafting window is a through hole communicated with the upper surface and the lower surface of the porous structure, the bone grafting window is arranged in the middle of the upper surface and the lower surface of the porous structure, the porosity of the porous structure close to the bone grafting window is high, the porosity of the porous structure far away from the bone grafting window is low, the porosity of the porous structure is uniformly distributed in the height direction of the porous structure, the height direction of the porous structure is perpendicular to the upper surface and the lower surface of the porous structure, the porosity of the porous structure is in gradient arrangement, the gradient ascending direction of the porosity of the porous structure is perpendicular to the direction of the outer edge line of the gradient porous cervical vertebra fusion device, a groove with a threaded hole is arranged at the front part of the porous structure, the pore diameter and the rod diameter of the pore of the porous structure are in gradient distribution, and the pore diameter of the pore of the porous structure is in direct proportion to the porosity of the porous structure, the rod diameter of the gap of the porous structure is inversely proportional to the porosity of the porous structure, the pore diameter range of the gap of the porous structure is 150-800 microns, the rod diameter range of the gap of the porous structure is 100-600 microns, the gap of the porous structure is obtained by adopting a pore-forming unit, the pore-forming unit is obtained by continuously biasing and closing on a two-dimensional plane based on a three-period minimum curved surface, the period of the three-period minimum curved surface is 0.5-2 mm, the size of the length, the width and the height of a cube surrounding box of the pore-forming unit is 0.5-2 mm, and the period of the three-period minimum curved surface is consistent with the size of the length, the width and the height of the cube surrounding box of the pore-forming unit; the method is characterized by comprising the following steps:
step 1: initially constructing an integral structure;
designing a rough drawing of an outer edge line of the porous structure according to the axial two-dimensional size of the porous structure by using three-dimensional modeling software, and inwards offsetting the outer edge line of the porous structure by 2-4 mm to obtain a rough drawing of an inner offset line, wherein the middle area of the outer edge line and the inner offset line is a design area of the porous structure, and the inner offset line is internally provided with the bone grafting window;
step 2: constructing a porosity distribution hierarchy of the porous structure;
in a closed area defined by the outer edge line and the inner bias line of the porous structure, the outer edge line of the porous structure is biased inwards at equal intervals, the range of the bias distance is 0.5-1 mm, 6 curves including the inner bias line and the outer edge line are obtained, and the closed curves from inside to outside are respectively named as a curve 1, a curve 2, a curve 3, a curve 4, a curve 5 and a curve 6;
and step 3: constructing coordinate data;
respectively taking data points on the curves 1 to 6 at equal intervals, selecting 10-30 points on each curve, wherein a point set on the curve 1 is called a point set 1, a point set on the curve 2 is called a point set 2, a point set on the curve 3 is called a point set 3, a point set on the curve 4 is called a point set 4, a point set on the curve 5 is called a point set 5, a point set on the curve 6 is called a point set 6, and respectively deriving coordinates of all the point sets to serve as data files;
and 4, step 4: designing a gradient value;
each of the curves 1 to 6 in the step 2 represents a porosity value, and the point set 1 to the point set 6 in the step 3 are used to replace the curves 1 to 6 to control the porosity distribution of the porous structure; the porosity of the curve 1 is set to 80%, the porosity of the curve 2 is set to 70%, the porosity of the curve 3 is set to 60%, the porosity of the curve 4 is set to 50%, the porosity of the curve 5 is set to 40%, and the porosity of the curve 6 is set to 30%, under which setting a gradient decreasing distribution of the porosity of the porous structure from inside to outside is achieved;
and 5: designing a control equation;
selecting a Gyoid unit in a three-period minimum curved surface unit as a pore-forming unit of the porous structure; the Gyoid unit is formed by a Gyoid surface, and the basic equation of the Gyoid surface with the period of 1 can be described as follows:
cos(2πx)sin(2πy)+cos(2πy)sin(2πz)+cos(2πz)sin(2πx)＝0；
defining the Gyoid curved surface as an interface of a solid part and a pore part of the porous structure,
the solid part of the porous structure is:
cos(2πx)sin(2πy)+cos(2πy)sin(2πz)+cos(2πz)sin(2πx)＜0；
the pore portion of the porous structure is:
cos(2πx)sin(2πy)+cos(2πy)sin(2πz)+cos(2πz)sin(2πx)＞0；
the offset design of the three-cycle infinitesimal curved surface unit moves the Gyoid curved surface to two sides by changing the basic equation of the Gyoid curved surface and the numerical values on the right sides of the solid part of the porous structure and the pore inequality, wherein the basic equation of the Gyoid curved surface and the numerical values on the right sides of the solid part of the porous structure and the pore inequality are called offset constants; according to the step 4, the porosities of the point sets 1 to 6 are respectively 80%, 70%, 60%, 50%, 40% and 30%, so that the bias constants are respectively 0.91,0.61,0.30,0, -0.30 and-0.61, and the control equation of the point set 1 is:
Figure FDA0003069793400000021
the control equation for calculating the point set 2 is:
Figure FDA0003069793400000022
the control equation for counting the point set 3 is:
Figure FDA0003069793400000023
the control equation for calculating the point set 4 is:
Figure FDA0003069793400000024
the control equation for counting the point set 5 is:
Figure FDA0003069793400000025
the governing equation for counting the point set 6 is:
Figure FDA0003069793400000026
step 6: establishing a global structural equation;
according to the above-mentioned step 3 to the above-mentioned step 5,
all coordinates of the point set 1 are counted as (x)1i,y1i) Wherein i is 1,2,3 … N, N is the number of points in the point set 1,
coordinate notation (x) for said set of points 22i,y2i) Wherein i is 1,2,3 … N, N is the number of points in the point set 2,
coordinate notation (x) for the set of points 33i,y3i) Wherein i is 1,2,3 … N, N is the number of points in the point set 3,
the coordinates of the set of points 4 are counted as (x)4i,y4i) Wherein i is 1,2,3 … N, N is the number of points in the point set 4,
the coordinates of the set of points 5 are counted as (x)5i,y5i) Wherein i is 1,2,3 … N, N is the number of points in the point set 5,
the coordinates of the set of points 6 are counted as (x)6i,y6i) Wherein i is 1,2,3 … N, N is the number of points in the point set 6,
and calculating a global structure equation as follows based on an inverse distance weighted interpolation algorithm of the space points:
Figure FDA0003069793400000031
in the formula, λjAs a weighting factor，
Figure FDA0003069793400000032
Figure FDA0003069793400000033
Wherein p is 2-4; epsilon is a small constant for preventing introduction of denominator 0, and epsilon is 0.0001-0.001
Figure FDA0003069793400000034
Determined for said step 5
Figure FDA0003069793400000035
Taking the three-period minimum curved surface unit curved surface
Figure FDA0003069793400000036
Is the boundary between the solid portion of the porous structure and the pore portion of the porous structure, and
Figure FDA0003069793400000037
is a solid part of the porous structure,
Figure FDA0003069793400000038
is a pore portion of the porous structure;
and 7: preliminarily constructing the porous structure;
writing the porous structure modeling program based on the three-cycle minimal curved surface unit according to the global structure equation, defining a calculation domain, realizing the porous structure modeling program based on the global structure equation and a Marching cube algorithm, and preliminarily constructing the porous structure by using three-dimensional modeling software;
and 8: further constructing the porous structure;
preliminarily perfecting a macroscopic model of the porous structure by using the three-dimensional modeling software, wherein the upper surface and the front surface of the porous structure are arc surfaces, and the rest surfaces of the porous structure are planes with a certain inclination angle; further constructing the porous structure by intersecting the macroscopic model of the porous structure with the step 6;
and step 9: building up the first tooth structure and the second tooth structure;
establishing the first tooth structure and the second tooth structure by using the three-dimensional modeling software, wherein the tooth heights of the first tooth structure and the second tooth structure are both 0.5-0.8 mm, the tooth rows of the first tooth structure and the second tooth structure are both 5-8, the tooth widths of two rows of teeth close to the front surface of the porous structure and one row of teeth close to the rear surface of the porous structure are consistent with the position widths of two side edges of the macroscopic model of the porous structure constructed in the step 8, and the tooth widths of the rest first tooth structure and the rest second tooth structure are both 2-3 mm;
step 10: constructing the groove with the threaded hole;
constructing the groove with the threaded hole on the front surface of the porous structure by using the three-dimensional modeling software;
step 11: performing Boolean operation;
and combining the porous structure obtained in the step 8, the first tooth structure and the second tooth structure obtained in the step 9, and the groove with the threaded hole obtained in the step 10 into a whole through Boolean operation.
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