CN110179570A - A kind of gradient porous cervical fusion cage and its design method - Google Patents

A kind of gradient porous cervical fusion cage and its design method Download PDF

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Publication number
CN110179570A
CN110179570A CN201910512299.1A CN201910512299A CN110179570A CN 110179570 A CN110179570 A CN 110179570A CN 201910512299 A CN201910512299 A CN 201910512299A CN 110179570 A CN110179570 A CN 110179570A
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porous
point
curve
toothing
porosity
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李祥
陈华江
高芮宁
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Shanghai Jiaotong University
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Shanghai Jiaotong University
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2/30942Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455Joints 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772Apertures or holes, e.g. of circular cross section
    • A61F2002/30784Plurality of holes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30818Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves castellated or crenellated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3093Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue
    • A61F2002/30945

Abstract

The invention discloses a kind of gradient porous cervical fusion cage and its design methods, are related to orthopaedics implant field, including porous structure, the first toothing, the second toothing, bone grafting window;The porous structure is porous hexahedron component, and the upper surface of the porous structure and front surface are arc surface, and the remaining surface of the porous structure is inclined plane, is seamlessly transitted between each surface of the porous structure;The upper surface of the porous structure is arranged in first toothing, and the lower surface of the porous structure is arranged in second toothing;The bone grafting window is the through-hole of the upper and lower surfaces of porous structure described in connection;Cervical fusion cage disclosed by the invention and its design method, the pore structure with gradient distribution, can effectively facilitate Invasive lumbar fusion device and be integrated with spinal fusion, reduce the advantages of stress is concentrated, has both good biomechanical property and biocompatibility.

Description

A kind of gradient porous cervical fusion cage and its design method
Technical field
The present invention relates to orthopaedics implant field more particularly to a kind of gradient porous cervical fusion cage and its design sides Method.
Background technique
Currently, cervical spine degeneration accounts for 50% or more in middle-aged population.Common cervical spine degeneration includes Cervical Disk Herniation, bone It is superfluous to be formed, after ligament fertilizer etc..Cervical spine degeneration often results in nerve dysfunction, needs to perform the operation when serious and be treated.Preceding road cervical vertebra Disc excision decompression and fusion is a kind of common surgical for treating cervical spine degeneration, and the purpose of operation is to obtain Bony union. Using cervical fusion cage, the bone graft that can be avoided in self bone fusion falls off, the risk of collapsing, restores intervertebral disc of cervical vertebra Highly, it relieves pain, releases the symptoms such as neurothlipsis, and promote the growth of bone, enhance the stability of centrum.
Porous structure is applied in the design of Invasive lumbar fusion device, can make Invasive lumbar fusion device that there is lot of advantages, main table It is existing are as follows: porous structure had both reduced the rigidity of fusion device material itself, avoided stress-shielding effect;Facilitate again bone tissue to It inside grows into hole, forms the entirety combined closely with fusion device, enhance its long-term stability.Good bone gap point Cloth can ensure that requirement and osteoacusis and the bone inductive effect of Invasive lumbar fusion device biomechanical property, be a kind of reason The Invasive lumbar fusion device structure thought.
Before the application day, the Invasive lumbar fusion device clinically used typically no pore structure, more not no gradient distribution Pore structure causes osteocyte that can not grow into fusion device, i.e., Invasive lumbar fusion device can not be integrated with spinal fusion and intervertebral melts The long-time stability of clutch are bad;Porous Invasive lumbar fusion device design disclosed in minority, pore structure used is all soft by CAD Part models to obtain, and there are a large amount of wedge angles for inside, causes stress concentration phenomenon fairly obvious, so that the weakening of intensity and toughness is caused, Its anti-fatigue performance is also very weak.
Therefore, those skilled in the art is dedicated to developing a kind of gradient porous cervical fusion cage and its design side Method promotes Invasive lumbar fusion device to be integrated with spinal fusion, stress concentration phenomenon is small, has both using the pore structure of gradient distribution Good biomechanical property and biocompatibility.
Summary of the invention
In view of the above drawbacks of the prior art, the technical problem to be solved by the present invention is to existing porous Invasive lumbar fusion devices Existing stress concentration phenomenon, intensity, rigidity and anti-fatigue performance be not high, and biomechanical property is low with biocompatibility.
To achieve the above object, the invention discloses a kind of gradient porous cervical fusion cages, which is characterized in that including Porous structure, the first toothing, the second toothing, bone grafting window;The porous structure is porous hexahedron component, described porous The upper surface of structure and front surface are arc surface, and the remaining surface of the porous structure is inclined plane, the porous knot It is seamlessly transitted between each surface of structure, the transition between each surface of the porous structure meets human anatomy design; The upper surface of the porous structure is arranged in first toothing, and second toothing is arranged under the porous structure Surface;The bone grafting window is the through-hole of the upper and lower surfaces of porous structure described in connection, and the bone grafting window is arranged described The middle part of porous structure upper and lower surfaces, porosity of the porous structure close to bone grafting window region is high, described more Porosity of the pore structure far from bone grafting window region is low, and the porosity of the porous structure is in the height side of the porous structure It is evenly distributed upwards, the short transverse of the porous structure is perpendicular to the upper surface of the porous structure and the side of lower surface To.
Further, the porosity of the porous structure is arranged in gradient, and the porosity gradient of the porous structure rises Direction is vertical with the border line direction of the gradient porous cervical fusion cage.
Further, the front of the porous structure is provided with groove with threaded hole.
Further, the aperture of the porous structure hole and the equal distribution gradient of bar diameter, the porous structure hole Aperture is directly proportional to the porosity of the porous structure, the bar diameter of the porous structure hole and the porosity of the porous structure It is inversely proportional, the pore diameter range of the porous structure hole is 150~800 μm, and the bar diameter range of the porous structure hole is 100 ~600 μm.
Further, the porous structure hole is obtained using pore-creating unit, and the pore-creating unit, which uses, was based on for three periods Minimal surface continuous biased closed on two-dimensional surface obtains, and the period of the three periods minimal surface is 0.5~2mm, described The square bounding box length and width of pore-creating unit and high size are 0.5~2mm, the period of the three periods minimal surface and institute The length and width for stating the square bounding box of pore-creating unit is consistent with high size.
Further, a height of 0.5~0.8mm of section tooth of the tooth of first toothing and second toothing, institute The range of numbers of teeth for stating the first toothing and second toothing is 6~10.
Further, porosity of the porous structure close to bone grafting window region is 70%~90%, described porous Structural edge region porosity is 15%~35%.
Further, the size range between the upper and lower surfaces of the gradient porous cervical fusion cage is 4 ~13mm, the size range between the front surface and rear surface of the gradient porous cervical fusion cage is 10~16mm, institute Stating the size range between the left surface of gradient porous cervical fusion cage and right surface is 12~18mm.
A kind of design method of gradient porous cervical fusion cage, which comprises the following steps:
Step 1: Primary Construction overall structure;
Using 3 d modeling software, the outer rim of the porous structure is designed according to the axial two-dimensional of the porous structure The border line of the porous structure is inwardly biased 2~4mm and obtains interior biasing line sketch by line sketch, the border line with Interior biasing line intermediate region is the design section of the porous structure, is the bone grafting window within the interior biasing line;
Step 2: constructing the porosity distribution level of the porous structure;
In the enclosed region that the border line of the porous structure and the interior biasing line surround, by the porous knot The inside iso-metric offset of the border line of structure, the range of offset or dish are 0.5~1mm, are obtained comprising the interior biasing line and described outer Totally 6 curves including edge line, closed curve from inside to outside are respectively designated as curve 1, curve 2, curve 3, curve 4, curve 5 With curve 6;
Step 3: building coordinate data;
It equidistantly fetches on the 1~curve of curve 6 respectively strong point, 10~30 points, the song is chosen on every curve Point set on line 1 is referred to as point set 1, and the point set on the curve 2 is referred to as point set 2, and the point set on the curve 3 is referred to as point set 3, institute It states the point set on curve 4 and is referred to as point set 4, the point set on the curve 5 is referred to as point set 5, and the point set on the curve 6 is referred to as point set 6, it regard the coordinate export of all point sets as data file respectively;
Step 4: design gradient value;
Every curve of curve 1 described in the step 2~curve 6 represents a porosity value, utilizes the step 1~the point set of point set 6 in rapid 3 controls the porosity distribution of the porous structure instead of the 1~curve of curve 6 System;The porosity of curve 1 is set as 80%, and the porosity of curve 2 is set as 70%, and the porosity of curve 3 is set as 60%, song The porosity of line 4 is set as 50%, and the porosity of curve 5 is set as 40%, and the porosity of curve 6 is set as 30%, this Under setting, the gradient decline distribution of the porosity of the porous structure from inside to outside is realized;
Step 5: design governing equation;
Choose pore-creating unit of the Gyoid unit in the three periods minimal surface unit as the porous structure;Institute It states Gyoid unit to be formed by Gyoid curved surface, the Gyoid curved surface fundamental equation that the period is 1 can be described as:
Cos (2 π x) sin (2 π y)+cos (2 π y) sin (2 π z)+cos (2 π z) sin (2 π x)=0;
The interface of entity part and aperture sections that the Gyoid curved surface is the porous structure is defined,
The entity part of the porous structure are as follows:
cos(2πx)sin(2πy)+cos(2πy)sin(2πz)+cos(2πz)sin(2πx)<0;
The aperture sections of the porous structure are as follows:
cos(2πx)sin(2πy)+cos(2πy)sin(2πz)+cos(2πz)sin(2πx)>0;
The offset design of the three periods minimal surface unit, by changing the Gyoid curved surface fundamental equation and institute The numerical value of the entity part of porous structure and the right of hole inequality is stated, to the Gyoid curved surface be moved to two sides, institute The numerical value for stating the entity part of Gyoid curved surface fundamental equation and the porous structure and the right of hole inequality is known as biasing Constant;According to the step 4, the corresponding porosity of the 1~point set of point set 6 is respectively 80%, 70%, 60%, 50%, 40%, 30%, therefore the offset constant is respectively 0.91,0.61,0.30,0, -0.30, -0.61, counts the control of the point set 1 Equation processed are as follows:
Count the governing equation of the point set 2 are as follows:
Count the governing equation of the point set 3 are as follows:
Count the governing equation of the point set 4 are as follows:
Count the governing equation of the point set 5 are as follows:
Count the governing equation of the point set 6 are as follows:
Step 6: establishing global structure equation;
According to the step 3~step 5,
All coordinates of the point set 1 are counted as (x1i,y1i), i=1 in formula, 2,3 ... N, N are 1 midpoint of point set Number,
The coordinate of the point set 2 is counted as (x2i,y2i), i=1 in formula, 2,3 ... N, N are the number at 2 midpoint of point set,
The coordinate of the point set 3 is counted as (x3i,y3i), i=1 in formula, 2,3 ... N, N are the number at 3 midpoint of point set,
The coordinate of the point set 4 is counted as (x4i,y4i), i=1 in formula, 2,3 ... N, N are the number at 4 midpoint of point set,
The coordinate of the point set 5 is counted as (x5i,y5i), i=1 in formula, 2,3 ... N, N are the number at 5 midpoint of point set,
The coordinate of the point set 6 is counted as (x6i,y6i), i=1 in formula, 2,3 ... N, N are the number at 6 midpoint of point set,
Inverse distance weighted interpolation algorithm based on spatial point, global structure equation is counted as:
In formula, λjFor weighted factor,
P=2~4 in formula;ε is 0 to prevent denominator The small constant introduced, ε=0.0001~0.001,For described in the step 4 determination~describedTake described three Period minimal surface unit curved surfaceFor point of the aperture sections of the entity part and porous structure of the porous structure Boundary line, andFor the entity part of the porous structure,For the aperture sections of the porous structure;
Step 7: porous structure described in Primary Construction;
According to the global structure equation, it is based on the three periods minimal surface unit, writes the porous structure modeling Program, and computational domain is defined, the porous structure modeling program is based on the global structure equation and MarchingCubes is calculated Method is realized, porous structure described in 3 d modeling software Primary Construction is utilized;
Step 8: further constructing the porous structure;
The macromodel that the porous structure is tentatively improved using the 3 d modeling software enables the upper of the porous structure Surface and front surface are arc surface, and the remaining surface of the porous structure is the plane with certain inclination angle;By the porous knot The macromodel of structure and the step 6, which seek common ground, further constructs the porous structure;
Step 9: constructing first toothing and second toothing;
First toothing and second toothing, first toothing are established using the 3 d modeling software Tooth height with second toothing is 0.5~0.8mm, and the tooth row number of first toothing and second toothing is equal For 5~8 rows, a toothrow of two toothrows close to the front surface of the porous structure and the rear surface close to the porous structure The facewidth of the facewidth and porous structure corresponding position equivalent width, remaining described first toothing and second toothing is equal For 2~3mm;
Step 10: the building groove with threaded hole;
The groove with threaded hole is constructed in the front surface of the porous structure using the 3 d modeling software;
Step 11: Boolean calculation;
First toothing and described second that the porous structure that the step 8 obtains, the step 9 are obtained Toothing, the groove with threaded hole obtained with the step 10, are merged into a single whole by Boolean calculation.
Further, in the step 5, D, P or IWP unit chosen in the three periods minimal surface unit replace institute Gyoid unit is stated, as the pore-creating unit.
Compared with prior art, beneficial effects of the present invention are as follows:
1, Invasive lumbar fusion device is designed as porous structure by the present invention, and retains bone grafting window, avoids stress shielding phenomenon, is promoted Into the rapid fusion of bone, the stability of long-term treatment increases;
2, porous structure is designed as gradient porous structure by the present invention, and the porous structure porosity close to bone grafting window is high, outside Fringe region porosity is low, and porosity gradient ascent direction is vertical with border line direction.The design of gradient porous structure can be same When meet biology and the requirement of mechanical performance.Center high porosity region is conducive to the migration of osteocyte, proliferation and differentiation, edge The region of low porosity then ensure that enough bearing requirements, and bone grafting window up and down promotes the rapid fusion of bone.
3, the present invention uses the pore-creating unit based on curved-surface structure, using three periods minimal surface pore-creating unit, inside Duct is continuous, without wedge angle, stress concentration is reduced, to improve intensity and anti-fatigue performance.
Detailed description of the invention
Fig. 1 is the gradient porous Invasive lumbar fusion device schematic diagram of a preferred embodiment of the invention;
Fig. 2 is the top view illustration of the gradient porous Invasive lumbar fusion device of a preferred embodiment of the invention;
Fig. 3 is the sectional view schematic diagram of the gradient porous Invasive lumbar fusion device of a preferred embodiment of the invention;
Fig. 4 is the pore-creating cell schematics of the gradient porous Invasive lumbar fusion device of a preferred embodiment of the invention;
Fig. 5 is the border line and inner edge line two-dimensional silhouette schematic diagram of a preferred embodiment of the invention;
Fig. 6 is the schematic diagram after the inside iso-metric offset curve of border line of a preferred embodiment of the invention;
Fig. 7 is the signal that point set is equidistantly taken on border line and its bias curve of a preferred embodiment of the invention Figure;
Fig. 8 is the skeleton pattern schematic diagram of the porous structure part of a preferred embodiment of the invention;
Fig. 9 is the porous structure schematic diagram of the belt edge characteristic face of a preferred embodiment of the invention;
Figure 10 is gradient porous the first toothing of neck Invasive lumbar fusion device and the second tooth of a preferred embodiment of the invention Structural schematic diagram;
Figure 11 is the threaded groove schematic diagram of a preferred embodiment of the invention;
Figure 12 is the gradient porous Invasive lumbar fusion device schematic diagram of another preferred embodiment of the invention.
Specific embodiment
Multiple preferred embodiments of the invention are introduced below with reference to Figure of description, keep its technology contents more clear and just In understanding.The present invention can be emerged from by many various forms of embodiments, and protection scope of the present invention not only limits The embodiment that Yu Wenzhong is mentioned.
In the accompanying drawings, the identical component of structure is indicated with same numbers label, everywhere the similar component of structure or function with Like numeral label indicates.The size and thickness of each component shown in the drawings are to be arbitrarily shown, and there is no limit by the present invention The size and thickness of each component.Apparent in order to make to illustrate, some places suitably exaggerate the thickness of component in attached drawing.
Embodiment 1:
In the present embodiment, patients with cervical disc height is 6mm, therefore taking Invasive lumbar fusion device height is 6mm, can also root Personalized customization is carried out according to patient's intervertenral space feature.
As shown in Figure 1, a kind of gradient porous cervical fusion cage provided in this embodiment includes porous structure 1, first Toothing 2, the second toothing 3, bone grafting window 4;Porous structure 1 is porous hexahedron component, and the upper surface of porous structure 1 is with before Surface is arc surface, and the remaining surface of porous structure 1 is inclined plane, smoothed between each surface of porous structure 1 It crosses, the transition between each surface of porous structure 1 meets human anatomy design;First toothing 2 is arranged in porous structure 1 Upper surface, the lower surface of porous structure 1 is arranged in the second toothing 3;As shown in Fig. 2, bone grafting window 4 is connection porous structure 1 Upper and lower surfaces through-hole, the middle part of 1 upper and lower surfaces of porous structure is arranged in bone grafting window 4, and porous structure 1 leans on The porosity in nearly 4 region of bone grafting window is high, and porosity of the porous structure 1 far from 4 region of bone grafting window is low, porous structure in the present embodiment Porosity close to bone grafting window region is 80%, and porous structure fringe region porosity is 30%, and gradient porous cervical intervertebral is melted Size a between the front surface and rear surface of clutch is 10mm, the left surface of gradient porous cervical fusion cage and right surface Between size b be 12mm.As shown in figure 3, the porosity of porous structure 1 is evenly distributed in the short transverse of porous structure 1, The short transverse of porous structure 1 is perpendicular to the upper surface of porous structure 1 and the direction of lower surface, and gradient porous cervical intervertebral is melted Size e between the upper and lower surfaces of clutch is 6mm.
The porosity of porous structure 1 is arranged in gradient, and the porosity gradient ascent direction of porous structure 1 is in gradient porous neck Vertebra Invasive lumbar fusion device border line direction is vertical.
The front of porous structure 1 is provided with groove with threaded hole.
1 hole of porous structure is obtained using pore-creating unit, as shown in figure 4, pore-creating cellular construction used by this example is Gyoid unit in three period minimal surface units, wherein pore-creating unit bounding box size is 1mm, the i.e. length of cellular construction body F, wide g, high h are 1mm.Unit porosity is 30%~90%, and the unit bounding box size of different porosities is 1mm.
The aperture of 1 hole of porous structure and the equal distribution gradient of bar diameter, the aperture of 1 hole of porous structure and porous structure 1 Porosity it is directly proportional, the bar diameter and the porosity of porous structure 1 of 1 hole of porous structure are inversely proportional, the hole of 1 hole of porous structure Diameter range is 150~800 μm, and the bar diameter range of 1 hole of porous structure is 100~600 μm.
First toothing 2 and the second toothing 3 all have 7 toothrows, and the high k of tooth is 0.5~0.8mm, and facewidth m is 2~ 3mm。
The design method of the gradient porous cervical fusion cage of the present embodiment the following steps are included:
Step 1: Primary Construction overall structure;
As shown in figure 5, designing porous structure 1 according to the axial two-dimensional of porous structure 1 using 3 d modeling software The border line of porous structure 1 is inwardly biased 3.5mm design interior biasing line sketch, the border line of porous structure 1 by border line sketch It is the design section of porous structure 1 with interior biasing line intermediate region, is bone grafting window 4 within interior biasing line;
Step 2: the porosity distribution level of building porous structure 1;
As shown in fig. 6, in the border line and the enclosed region that surrounds of interior biasing line of porous structure 1, by porous structure 1 The inside iso-metric offset of border line goes out 5 curves, from 3.5mm offset or dish is 0.7mm, closing from inside to outside according to interior offset distance It closes curve and is respectively designated as curve 1, curve 2, curve 3, curve 4, curve 5 and curve 6;
Step 3: building coordinate data;
As shown in fig. 7, the strong point n that equidistantly fetches on 1~curve of curve 6 respectively, 20 points are chosen on every curve, it will be bent Point set on line 1 is referred to as point set 1, and so on, and it regard the coordinate export of all point sets as data file respectively;
Step 4: design gradient value;
Every curve of 1~curve of curve 6 represents a porosity value in step 2, and using the point set 1 in step 3~ Point set 6 controls the porosity distribution of porous structure 1 instead of 1~curve of curve 6;Curve 1 is set as 80%, 2 hole of curve Gap rate is again set at 70%, and 3 porosity of curve is set as 60%, and the porosity of curve 4 is set as 50%, the hole of curve 5 Rate is set as 40%, and the porosity on curve 6 is set as 30%, under this setting, realize the porosity of porous structure 1 by Gradient from inside to outside declines distribution;
Step 5: design governing equation;
Choose pore-creating unit of the Gyoid unit in three period minimal surface units as porous structure 1;Gyoid unit It is formed by Gyoid curved surface, the Gyoid curved surface fundamental equation that the period is 1 can be described as:
Cos (2 π x) sin (2 π y)+cos (2 π y) sin (2 π z)+cos (2 π z) sin (2 π x)=0;
The interface of entity part and aperture sections that Gyoid curved surface is porous structure 1 is defined,
The entity part of porous structure 1 are as follows:
cos(2πx)sin(2πy)+cos(2πy)sin(2πz)+cos(2πz)sin(2πx)<0;
The aperture sections of porous structure 1 are as follows:
cos(2πx)sin(2πy)+cos(2πy)sin(2πz)+cos(2πz)sin(2πx)>0;
The offset design of three period minimal surface units, by changing Gyoid curved surface fundamental equation and porous structure 1 The numerical value on the right of entity part and hole inequality, to Gyoid curved surface be moved to two sides, Gyoid curved surface fundamental equation And the numerical value on the right of the entity part and hole inequality of porous structure 1 is known as offset constant;According to step 4, point set 1~ The corresponding porosity of point set 6 is respectively 80%, 70%, 60%, 50%, 40%, 30%, therefore offset constant is respectively 0.91, 0.61,0.30,0, -0.30, -0.61, the governing equation of enumeration collection 1 are as follows:
Count the governing equation of the point set 2 are as follows:
Count the governing equation of the point set 3 are as follows:
Count the governing equation of the point set 4 are as follows:
Count the governing equation of the point set 5 are as follows:
Count the governing equation of the point set 6 are as follows:
Step 6: establishing global structure equation;
According to step 3~step 5,
All coordinates of point set 1 are counted as (x1i,y1i), i=1 in formula, 2,3 ... N, N are the number at 1 midpoint of point set,
The coordinate of point set 2 is counted as (x2i,y2i), i=1 in formula, 2,3 ... N, N are the number at 2 midpoint of point set,
The coordinate of point set 3 is counted as (x3i,y3i), i=1 in formula, 2,3 ... N, N are the number at 3 midpoint of point set,
The coordinate of point set 4 is counted as (x4i,y4i), i=1 in formula, 2,3 ... N, N are the number at 4 midpoint of point set,
The coordinate of point set 5 is counted as (x5i,y5i), i=1 in formula, 2,3 ... N, N are the number at 5 midpoint of point set,
The coordinate of point set 6 is counted as (x6i,y6i), i=1 in formula, 2,3 ... N, N are the number at 6 midpoint of point set,
Inverse distance weighted interpolation algorithm based on spatial point, global structure equation is counted as:
In formula, λjFor weighted factor,
P=2~4 in formula;ε is 0 to prevent denominator The small constant introduced, ε=0.0001~0.001,It is determined for step 4Take three period minimal surface units Curved surfaceFor the line of demarcation of the aperture sections of the entity part and porous structure 1 of porous structure 1, andIt is porous The entity part of structure 1,For the aperture sections of porous structure 1;
Step 7: Primary Construction porous structure 1;
According to global structure equation, three period minimal surface units are based on, write 1 modeling program of porous structure, and define Computational domain, which is based on global structure equation and Marching Cubes algorithm is realized, preliminary using 3 d modeling software Construct porous structure 1;STL model is directly exported by modeling program;
Step 8: further building porous structure 1;
As shown in figure 8, tentatively improving the macromodel of porous structure 1 using 3 d modeling software, the upper of porous structure 1 is enabled Surface and front surface are arc surface, and the surface of remaining porous structure 1 is the plane with certain inclination angle;Internal run-through hole is as plant Bone window 4;As shown in figure 9, the macromodel of porous structure 1 and step 6, which are sought common ground, further constructs porous structure 1;
Step 9: the first toothing 2 of building and the second toothing 3;
As shown in Figure 10, the first toothing 2 and the second toothing 3 are established using 3 d modeling software, tooth a height of 0.5~ 0.8mm, number of rows are 7 rows, in the first toothing 2 and the second toothing 3, close to porous structure 1 front surface two toothrows with Close to the facewidth and 1 corresponding position equivalent width of porous structure of a toothrow of the rear surface of porous structure 1, remaining first toothing The facewidth with the second toothing is 2~3mm;
Step 10: constructing groove with threaded hole;
As shown in figure 11, groove with threaded hole is constructed using 3 d modeling software;
Step 11: Boolean calculation;
The first toothing 2 and the second toothing 3 that porous structure 1 that step 8 obtains, step 9 are obtained, with step 10 The groove with threaded hole arrived, is merged into a single whole by Boolean calculation.
Embodiment 2:
In the present embodiment, patients with cervical disc height is 4mm, therefore taking Invasive lumbar fusion device height is 4mm, can also root Personalized customization is carried out according to patient's intervertenral space feature.
On the basis of embodiment 1, porosity of the porous structure close to bone grafting window region is 90%, porous structure marginal zone Domain porosity is 20%, and the size a between the front surface and rear surface of gradient porous cervical fusion cage is 16mm, and gradient is more Size b between the left surface of hole cervical fusion cage and right surface is 18mm.
Under the design method of the gradient porous cervical fusion cage of the present embodiment carries out like that on the basis of embodiment 1 Change: in steps of 5, the D unit or P unit or IWP unit chosen in three period minimal surface units replace Gyoid unit, As the pore-creating unit of porous structure 1, change the curved surface side of three period minimal surface units when constructing governing equation accordingly Journey.
Embodiment 3:
On the basis of embodiment 1, as shown in figure 12, gradient porous cervical fusion cage is changed to the knot of no bone grafting window 4 Structure.
The preferred embodiment of the present invention has been described in detail above.It should be appreciated that the ordinary skill of this field is without wound The property made labour, which according to the present invention can conceive, makes many modifications and variations.Therefore, all technician in the art Pass through the available technology of logical analysis, reasoning, or a limited experiment on the basis of existing technology under this invention's idea Scheme, all should be within the scope of protection determined by the claims.

Claims (10)

1. a kind of gradient porous cervical fusion cage, which is characterized in that including porous structure, the first toothing, the second tooth knot Structure, bone grafting window;The porous structure is porous hexahedron component, and the upper surface of the porous structure and front surface are circular arc Face, the remaining surface of the porous structure are inclined plane, are seamlessly transitted between each surface of the porous structure, institute It states the transition between each surface of porous structure and meets human anatomy design;First toothing is arranged described porous The lower surface of the porous structure is arranged in the upper surface of structure, second toothing;The bone grafting window is more described in connection The through-hole of the upper and lower surfaces of pore structure, the bone grafting window are arranged in the porous structure upper and lower surfaces Portion, porosity of the porous structure close to bone grafting window region is high, and the porous structure is far from bone grafting window region Porosity is low, and the porosity of the porous structure is evenly distributed in the short transverse of the porous structure, the porous structure Short transverse be perpendicular to the upper surface of the porous structure and the direction of lower surface.
2. a kind of gradient porous cervical fusion cage as described in claim 1, which is characterized in that the hole of the porous structure Gap rate is arranged in gradient, the porosity gradient ascent direction of the porous structure and the gradient porous cervical fusion cage Border line direction is vertical.
3. a kind of gradient porous cervical fusion cage as claimed in claim 2, which is characterized in that before the porous structure Portion is provided with groove with threaded hole.
4. a kind of gradient porous cervical fusion cage as claimed in claim 3, which is characterized in that the porous structure hole Aperture and the equal distribution gradient of bar diameter, the aperture of the porous structure hole is directly proportional to the porosity of the porous structure, The bar diameter and the porosity of the porous structure of the porous structure hole are inversely proportional, the pore diameter range of the porous structure hole It is 150~800 μm, the bar diameter range of the porous structure hole is 100~600 μm.
5. a kind of gradient porous cervical fusion cage as claimed in claim 4, which is characterized in that the porous structure hole It is obtained using pore-creating unit, the pore-creating unit is used to be obtained based on three period minimal surfaces continuous biased closed on two-dimensional surface It arrives, period of the three periods minimal surface is 0.5~2mm, the square bounding box length and width of the pore-creating unit and high big Small is 0.5~2mm, the length and width and height of the square bounding box of the period of the three periods minimal surface and the pore-creating unit Size it is consistent.
6. a kind of gradient porous cervical fusion cage as claimed in claim 5, which is characterized in that first toothing and A height of 0.5~the 0.8mm of section tooth of the tooth of second toothing, the number of teeth of first toothing and second toothing Range is 6~10.
7. a kind of gradient porous cervical fusion cage as claimed in claim 6, which is characterized in that the porous structure is close The porosity in bone grafting window region is 70%~90%, and the porous structure fringe region porosity is 15%~35%.
8. a kind of gradient porous cervical fusion cage as claimed in claim 7, which is characterized in that the gradient porous cervical vertebra Size range between the upper and lower surfaces of Invasive lumbar fusion device is 4~13mm, the gradient porous cervical fusion cage Front surface and rear surface between size range be 10~16mm, the left surface of the gradient porous cervical fusion cage and Size range between right surface is 12~18mm.
9. the design method of the gradient porous cervical fusion cage as described in claim 5 to 8 is any, which is characterized in that packet Include following steps:
Step 1: Primary Construction overall structure;
Using 3 d modeling software, the border line grass of the porous structure is designed according to the axial two-dimensional of the porous structure The border line of the porous structure is inwardly biased 2~4mm and obtains interior biasing line sketch by figure, the border line with it is described Interior biasing line intermediate region is the design section of the porous structure, is the bone grafting window within the interior biasing line;
Step 2: constructing the porosity distribution level of the porous structure;
In the enclosed region that the border line of the porous structure and the interior biasing line surround, by the porous structure The inside iso-metric offset of border line, the range of offset or dish are 0.5~1mm, are obtained comprising the interior biasing line and the border line Totally 6 curves inside, closed curve from inside to outside are respectively designated as curve 1, curve 2, curve 3, curve 4, curve 5 and song Line 6;
Step 3: building coordinate data;
It equidistantly fetches on the 1~curve of curve 6 respectively strong point, chooses 10~30 points on every curve, on the curve 1 Point set be referred to as point set 1, the point set on the curve 2 is referred to as point set 2, and the point set on the curve 3 is referred to as point set 3, the song Point set on line 4 is referred to as point set 4, and the point set on the curve 5 is referred to as point set 5, and the point set on the curve 6 is referred to as point set 6, point The coordinate export of all point sets is not regard it as data file;
Step 4: design gradient value;
Every curve of curve 1 described in the step 2~curve 6 represents a porosity value, using in the step 3 The 1~point set of point set 6 porosity distribution of the porous structure is controlled instead of the 1~curve of curve 6;Curve 1 porosity is set as 80%, and the porosity of curve 2 is set as 70%, and the porosity of curve 3 is set as 60%, the hole of curve 4 Gap rate is set as 50%, and the porosity of curve 5 is set as 40%, and the porosity of curve 6 is set as 30%, under this setting, Realize the gradient decline distribution of the porosity of the porous structure from inside to outside;
Step 5: design governing equation;
Choose pore-creating unit of the Gyoid unit in the three periods minimal surface unit as the porous structure;It is described Gyoid unit is formed by Gyoid curved surface, and the Gyoid curved surface fundamental equation that the period is 1 can be described as:
Cos (2 π x) sin (2 π y)+cos (2 π y) sin (2 π z)+cos (2 π z) sin (2 π x)=0;
The interface of entity part and aperture sections that the Gyoid curved surface is the porous structure is defined,
The entity part of the porous structure are as follows:
cos(2πx)sin(2πy)+cos(2πy)sin(2πz)+cos(2πz)sin(2πx)<0;
The aperture sections of the porous structure are as follows:
cos(2πx)sin(2πy)+cos(2πy)sin(2πz)+cos(2πz)sin(2πx)>0;
The offset design of the three periods minimal surface unit, by changing the Gyoid curved surface fundamental equation and described more The numerical value on the right of the entity part and hole inequality of pore structure, thus the Gyoid curved surface is mobile to two sides, it is described The numerical value on the right of the entity part and hole inequality of Gyoid curved surface fundamental equation and the porous structure is known as biasing normal Number;According to the step 4, the corresponding porosity of the 1~point set of point set 6 is respectively 80%, 70%, 60%, 50%, 40%, 30%, therefore the offset constant is respectively 0.91,0.61,0.30,0, -0.30, -0.61, counts the governing equation of the point set 1 Are as follows:
Count the governing equation of the point set 2 are as follows:
Count the governing equation of the point set 3 are as follows:
Count the governing equation of the point set 4 are as follows:
Count the governing equation of the point set 5 are as follows:
Count the governing equation of the point set 6 are as follows:
Step 6: establishing global structure equation;
According to the step 3~step 5,
All coordinates of the point set 1 are counted as (x1i,y1i), i=1 in formula, 2,3 ... N, N are the number at 1 midpoint of point set,
The coordinate of the point set 2 is counted as (x2i,y2i), i=1 in formula, 2,3 ... N, N are the number at 2 midpoint of point set,
The coordinate of the point set 3 is counted as (x3i,y3i), i=1 in formula, 2,3 ... N, N are the number at 3 midpoint of point set,
The coordinate of the point set 4 is counted as (x4i,y4i), i=1 in formula, 2,3 ... N, N are the number at 4 midpoint of point set,
The coordinate of the point set 5 is counted as (x5i,y5i), i=1 in formula, 2,3 ... N, N are the number at 5 midpoint of point set,
The coordinate of the point set 6 is counted as (x6i,y6i), i=1 in formula, 2,3 ... N, N are the number at 6 midpoint of point set,
Inverse distance weighted interpolation algorithm based on spatial point, global structure equation is counted as:
In formula, λjFor weighted factor,
P=2~4 in formula;ε is 0 introduction to prevent denominator A small constant, ε=0.0001~0.001,For described in the step 4 determination~describedTake three period Minimal surface unit curved surfaceFor the boundary of the aperture sections of the entity part and porous structure of the porous structure Line, andFor the entity part of the porous structure,For the aperture sections of the porous structure;
Step 7: porous structure described in Primary Construction;
According to the global structure equation, it is based on the three periods minimal surface unit, writes the porous structure modeling program, And computational domain is defined, the porous structure modeling program is based on the global structure equation and Marching Cubes algorithm is real It is existing, utilize porous structure described in 3 d modeling software Primary Construction;
Step 8: further constructing the porous structure;
The macromodel that the porous structure is tentatively improved using the 3 d modeling software enables the upper surface of the porous structure It is arc surface with front surface, the remaining surface of the porous structure is the plane with certain inclination angle;By the porous structure Macromodel and the step 6, which seek common ground, further constructs the porous structure;
Step 9: constructing first toothing and second toothing;
First toothing and second toothing, first toothing and institute are established using the 3 d modeling software The tooth height for stating the second toothing is 0.5~0.8mm, and the tooth row number of first toothing and second toothing is 5 The tooth of one toothrow of~8 rows, two toothrows close to the front surface of the porous structure and the rear surface close to the porous structure It is wide with porous structure corresponding position equivalent width, the facewidth of remaining described first toothing and second toothing is 2~3mm;
Step 10: the building groove with threaded hole;
The groove with threaded hole is constructed in the front surface of the porous structure using the 3 d modeling software;
Step 11: Boolean calculation;
First toothing and the second tooth knot that the porous structure that the step 8 obtains, the step 9 are obtained Structure, the groove with threaded hole obtained with the step 10, are merged into a single whole by Boolean calculation.
10. the design method of gradient porous cervical fusion cage as claimed in claim 9, which is characterized in that the step 5 In, D, P or IWP unit chosen in the three periods minimal surface unit replace the Gyoid unit, as the pore-creating list Member.
CN201910512299.1A 2019-06-13 2019-06-13 A kind of gradient porous cervical fusion cage and its design method Pending CN110179570A (en)

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