CN104318009B - A kind of personalized Invasive lumbar fusion device design method - Google Patents
A kind of personalized Invasive lumbar fusion device design method Download PDFInfo
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Abstract
The present invention relates to a kind of personalized Invasive lumbar fusion device design method, centrum is carried out CT scan by methods described, then CT Serial slices of image data are subjected to reconstructing three-dimensional model, and vertebral model is measured, including measurement centrum sagittal diameter, the horizontal shape footpath of centrum, disc height etc..Personalized designs and the implantation of Invasive lumbar fusion device are carried out on the basis of measurement parameter, the foundation of FEM model is completed by mesh generation and smooth, material assignment and boundary condition setting etc., finally carry out the solution and analysis of FEM model, foundation is provided for the Optimal improvements of Invasive lumbar fusion device, and finally realizes and had both considered geometric match it is further contemplated that the design of the personalized Invasive lumbar fusion device of function match.
Description
Technical field
The present invention relates to a kind of personalized Invasive lumbar fusion device design method, CT images are based on more particularly to one kind
The method that three-dimensional reconstruction and e measurement technology, finite element analysis technology carry out personalized designs to Invasive lumbar fusion device.
Background technology
In clinical interbody fusion, implantation, size, spatial form and neurotrosis, the plant of Invasive lumbar fusion device
Enter stability, intervertebral bone graft amount closely related.But, because physiological parameter and the difference of vivo environment individualized feature compared with
Greatly, standardization, mass, the interaction of the Invasive lumbar fusion device and human body of serializing production are difficult to optimize, and cause some vertebras
Between after fusion device enters in vivo, occur excessive wear, fatigue failure etc..Therefore, the design of Invasive lumbar fusion device must be personalized
's.Invasive lumbar fusion device faces the ambient stress of complexity in vivo, and what these stress can both influence Invasive lumbar fusion device self structure can
By property, also the normal performance of Invasive lumbar fusion device function and surrounding host tissue can be influenceed to change reconstruction, be Invasive lumbar fusion device success or failure
One of key factor.Therefore, the performance of Invasive lumbar fusion device will not only consider that its material type selecting, preparation and surface are modified, and should also
Take into full account that it turns into the configuration of medicine equipment and designed, and its interaction between surrounding host tissue.At present, mostly
The design of several Invasive lumbar fusion devices is based on geometric match demand, is not carried out based on function match design.
The content of the invention
In order to overcome the design of current most Invasive lumbar fusion device to be based on geometric match demand, it is not carried out being based on function
The problem of matched design, the invention discloses a kind of personalized Invasive lumbar fusion device design method, methods described is by using CT
Three-dimensional reconstruction, the anatomical structure feature of prevertebrate is gone back under digital virtual environment and three-dimensional measurement is carried out, in this base
Personalized designs and the implantation of Invasive lumbar fusion device are carried out on plinth, designed intervertebral is melted with personalized finite element analysis technology
Clutch is analyzed and improved.
The present invention according to actual needs, imports the view data such as CT/MRI in the software CageDesigner developed,
The segmentation of spinal vertebral is automatically carried out, the geometrical model of backbone is set up, the mesh generation of model is automatically carried out, and can be simulated
Spinal interbody fusion surgical procedure and progress finite element analysis, reference is provided for the personalized designs of Invasive lumbar fusion device.
The invention discloses a kind of personalized Invasive lumbar fusion device design method, following steps are specifically included:
1) IMAQ and pretreatment：Vertebra is subjected to CT scan, the original for the vertebra for then obtaining CT scanner
Beginning data import in software and carry out auto-sequencing and judgement to image according to the numbering of image.Then the CT images of importing are entered
Row medium filtering, gaussian filtering and binary conversion treatment.
2) segmentation of centrum image and the foundation of threedimensional model：One is selected manually initially in software level face view area first
Lamella starts cutting procedure, and then the centrum general profile of the initial lamella of manual drawing pass through iteration using Level Set Method
Obtain the centrum precise boundary of initial lamella.Hereafter cutting procedure will be by starting point of reference layer from upper and lower both direction
Cutting operation is carried out to all lamellas.Because the amplitude of variation of centrum CT image adjacent sheets targets is smaller, therefore handy it can locate
Profile obtained by the segmentation result of lamella is managed as the initial profile of adjacent sheets, then all centrums are obtained with Level Set Method
Precise boundary.Finally, acquired profile can be modified using manual method.For the result of segmentation, using body painting
Method processed is drawn, and is shown in the window.
3) vertebral model is measured：Centrum sagittal diameter and the horizontal shape footpath of centrum are obtained in the upper soleplate plane of vertebral model
Take.Using the cutting function of software, cutting three-dimensional vertebral model obtains soleplate plane on vertebral model.Looked in soleplate plane
To anterior-posterior axle of the vertebral model into left and right two halves is divided equally, the distance between measurement anterior-posterior axle and the intersection point of vertebral model edge two should
Distance as centrum sagittal diameter.Distance between measurement and the perpendicular intersection point of straight line vertebral model edge two of anterior-posterior axle, its middle-range
From the maximum as horizontal shape footpath of centrum.The height of intervertenral space is measured in vertebral model median sagittal plane.In median sagittal plane
The upper front and rear edges point and soleplate central point for obtaining terminal plate of vertebral body manually.The distance of terminal plate of vertebral body leading edge point is above and below measurement
Intervertenral space leading edge height, the distance of 2 terminal plate of vertebral body trailing edge points is intervertenral space trailing edge height, and the distance of two soleplate central points is
For intervertenral space centre-height.
4) design and implantation of Invasive lumbar fusion device：In existing Invasive lumbar fusion device model library, according to the upper limb solution of centrum
Form (curve, platform) is cutd open, the geometry (radian) of fusion device is selected, the height of Invasive lumbar fusion device is determined according to disc height
Degree, according to centrum transverse diameter, centrum radius vector determines the length and width of Invasive lumbar fusion device.The principle of design is to paste Invasive lumbar fusion device
Anatomical structure is closed, bigger contact area is reached, mechanical strength is met, promotes fusion.It is for double pieces of Invasive lumbar fusion devices, its is right
It is latter half of that title is implanted in centrum.For single fusion cage, it is tiltedly implanted into centrum center.
5) FEM meshing and smooth：Mesh generation is carried out to centrum using the Meshing Method based on voxel.
First by the pixel of each several part with different coded representations；Then 8 adjacent pixels of levels are connected into 1 as node
Voxel, remove redundancy voxel, using remaining voxel as eight nodes hexahedral element.In model surface and different materials
Expect that the pixel coder of eight nodes of the unit of interface is different, now using the method for mirror image subdivision each border
Hexahedral element is decomposed into 5 tetrahedron elements, and the flat of interface is then carried out by the node of these mobile tetrahedron elements
It is sliding；In order to reduce amount of calculation, it will be merged as needed for some consistent units of material.Using the method for mapping by
The finite element grid of Modular Intervertebral fusion device model in some Invasive lumbar fusion device model libraries is mapped to designed personalized vertebra
Between on fusion device, realize the mesh generation of Invasive lumbar fusion device.
6) assignment of material and boundary condition are set：The modulus of elasticity of range site node densitometer calculated unit, is set
Model thickness of cortex of bone and Minor articulus coefficient of friction, it is assumed that cancellous bony material is isotropism, between Invasive lumbar fusion device and centrum
Using surface-to-surface contact.All frees degree of lower soleplate of hypocentrum are all fixed, and the upper soleplate central point R of centrum, passes through in selection
On R apply downward pressure simulation centrum load-bearing, apply torque simulation it is anteflexion, after stretch, lateral bending, torsion.It is complete by above-mentioned steps
Into the foundation for the centrum FEM model for being implanted with Invasive lumbar fusion device.
7) solution and analysis of FEM model：Centrum FEM model is entered using voxel FEM model derivation algorithm
Row is solved, and obtains maximum principal stress, and equivalent stress is sunk and displacement, for evaluating the stress distribution of centrum and Invasive lumbar fusion device
Situation and misalignment, so that it is determined that whether design is reasonable.For irrational design, return to step 4 pair design and repair
Change, and finally realize and both considered geometric match it is further contemplated that the design of the personalized Invasive lumbar fusion device of function match.Final design
Personalized Invasive lumbar fusion device is exported with STL forms.
Personalization Invasive lumbar fusion device design method advantage of the invention includes：
1st, consider geometric match and function match comprehensively in the design, personalized finite element analysis technology is incorporated into intervertebral
In the design of fusion device.
2nd, the horizontal shape footpath of parameter such as centrum that display vertebra shape measures reaction vertebral body structure feature comprehensively can be visualized,
Centrum sagittal diameter, disc height etc.；
3rd, design method is easy, and the operating time is short, it is easy to clinical expansion.
Brief description of the drawings
Fig. 1 is personalized Invasive lumbar fusion device design specific implementation flow chart according to an embodiment of the invention；
Fig. 2 is that the soleplate plane according to an embodiment of the invention on centrum carries out parameter measurement schematic diagram；
Fig. 3 is according to an embodiment of the invention in centrum median plane progress parameter measurement schematic diagram；
Fig. 4 is double piece Invasive lumbar fusion device implantation position schematic diagrames of the present invention；
Fig. 5 is the single fusion cage implantation position schematic diagram of the present invention；
Fig. 6 is the centrum mesh generation result figure of one embodiment of the present of invention；
Fig. 7 is the personalized Invasive lumbar fusion device designed by one embodiment of the present of invention.
Embodiment
As shown in figure 1, being personalized Invasive lumbar fusion device design specific implementation flow according to an embodiment of the invention
Figure, comprises the following steps：
Step 101：IMAQ and pretreatment.
CT scan is carried out to vertebra, vertebra CT images are obtained.The raw image data of the vertebra of acquisition is imported soft
Auto-sequencing and judgement are carried out to image in part and according to the numbering of image.Then the CT images of importing are carried out medium filtering,
Gaussian filtering and binary conversion treatment.
Step 102：The segmentation of centrum image and the foundation of threedimensional model.
Select an initial lamella manually to start cutting procedure in software level face view area first, manual drawing is initial
The centrum general profile of lamella, then obtains the centrum precise boundary of initial lamella using Level Set Method by iteration.Hereafter
Cutting procedure will by starting point of reference layer from upper and lower both direction to all lamellas carry out cutting operation.Due to centrum
The amplitude of variation of CT image adjacent sheets targets is smaller, thus can handy processed lamella segmentation result obtained by profile as adjacent
The initial profile of lamella, then obtains the precise boundary of all centrums with Level Set Method.Finally, manual method pair can be used
Acquired profile is modified.For the result of segmentation, drawn, and shown in the window using object plotting method
Show.
Step 103：Vertebral model is measured.
Centrum sagittal diameter and horizontal shape footpath are obtained in the upper soleplate plane of vertebral model.Using the cutting work(of software
Can, cutting three-dimensional vertebral model obtains the upper soleplate plane (Fig. 2) of centrum.Found in soleplate plane and divide vertebral model Cheng Zuo equally
The anterior-posterior axle L (Fig. 2) of right two halves, the distance between measurement anterior-posterior axle L and vertebral model edge two intersection point C, D (Fig. 2), the distance
The as sagittal diameter of centrum.Measurement and the distance between the perpendicular straight lines of anterior-posterior axle L and the intersection point of vertebral model edge two, wherein
Distance between two maximum point A, B (Fig. 2) of distance is the horizontal shape footpath of centrum.The height of intervertenral space is in vertebral model median sagittal plane
(Fig. 3) is measured.Obtain front and rear edges point E, F, G, H (Fig. 3) and soleplate of terminal plate of vertebral body manually on median sagittal plane
Central point I, J (Fig. 3).The distance of terminal plate of vertebral body leading edge point F, H (Fig. 3) is intervertenral space leading edge height, two centrums above and below measurement
Soleplate trailing edge point E, G (Fig. 3) distance are intervertenral space trailing edge height, and two soleplate central point I, J (Fig. 3) distance is intervertebral
Gap centre-height.
Step 104：The design and implantation of Invasive lumbar fusion device.
In existing Invasive lumbar fusion device model library, according to the upper limb anatomic form (curve, platform) of centrum, selection fusion
The geometry (radian) of device, the height of Invasive lumbar fusion device is determined according to disc height, according to centrum transverse diameter, centrum radius vector
Determine the length and width of Invasive lumbar fusion device.The principle of design is to make Invasive lumbar fusion device laminating anatomical structure, reaches bigger connect
Contacting surface is accumulated, and meets mechanical strength, promotes fusion.For double pieces of Invasive lumbar fusion devices, it is symmetrically implanted in the latter half of (figure of centrum
4).Vertebral rim is inside contracted 1/3rd first, the gray area shown in Fig. 4 is obtained, Invasive lumbar fusion device can not be implanted into the part.
One piece of Invasive lumbar fusion device is alignd with point D (Fig. 4), moved to the right, until it is contacted with gray area, this piece of intervertebral is completed
The determination of the implantation position of fusion device, is then symmetrically positioned another piece of Invasive lumbar fusion device.For single fusion cage, by it
Tiltedly implantation centrum center (Fig. 5).Intervertebral is melted into 45 degree of placements in Invasive lumbar fusion device major axis h directions and centrum sagittal diameter first
Clutch trailing edge is overlapped with point D (Fig. 5), then moves in parallel Invasive lumbar fusion device to side, until Invasive lumbar fusion device major axis h passes through vertebra
Body center O (Fig. 5), completes the implantation of single fusion cage.
Step 105：FEM meshing and smooth.
Mesh generation is carried out to centrum using the Meshing Method based on voxel.It is first that the pixel of each several part is different
Coded representation；Then 1 voxel is connected into using 8 adjacent pixels of levels as node, removes the voxel of redundancy, will be surplus
Remaining voxel as eight nodes hexahedral element.In eight nodes of the unit of model surface and different materials interface
Pixel coder be different, each border hexahedral element is now decomposed into using the method for mirror image subdivision by 5 four sides
Body unit, then carries out the smooth of interface by the node of these mobile tetrahedron elements；In order to reduce amount of calculation, for material
Some consistent units of material will be merged as needed.Using the method for mapping by existing Invasive lumbar fusion device model library
The finite element grid of Modular Intervertebral fusion device model is mapped on designed personalized Invasive lumbar fusion device, realizes Invasive lumbar fusion device
Mesh generation.One fructufy of FEM meshing is for example shown in Fig. 6.
Step 106：The assignment and boundary condition of material are set.
The modulus of elasticity of range site node densitometer calculated unit, sets model thickness of cortex of bone and Minor articulus friction system
Number, it is assumed that cancellous bony material is isotropism, uses surface-to-surface contact between Invasive lumbar fusion device and centrum.The lower soleplate of hypocentrum
All frees degree are all fixed, the upper soleplate central point R of centrum in selection, held by applying downward pressure simulation centrum on R
Weight, apply torque simulation it is anteflexion, after stretch, lateral bending, torsion.By above-mentioned steps, the centrum for completing to be implanted with Invasive lumbar fusion device is limited
The foundation of meta-model.
Step 107：The solution and analysis of FEM model.
Conventional algorithm EBE-PCG (element by element precon- are solved using voxel FEM model
Ditioned conjugate gradient) algorithm solved, and obtains maximum principal stress, and equivalent stress is sunk and displacement,
For evaluating the stress distribution situation and misalignment of centrum and Invasive lumbar fusion device, so that it is determined that whether design is reasonable.For not
Rational design, return to step 4 pair design and modify, and finally realize and both considered geometric match it is further contemplated that function match
The design of personalized Invasive lumbar fusion device.The personalized Invasive lumbar fusion device of final design exports (Fig. 7) with STL forms.
The design of embodiment personalization lumbar intervertebral fusion device
L3-L4 lumbar vertebraes are subjected to CT scan, sweep parameter:Thickness 0.63mm, layer is away from 0.63mm, bulb voltage
120kV, electric current 225mAs, resolution ratio 512*512pxl, obtain 150 lumbar vertebrae CT images.This 150 CT data are imported into software
Middle progress medium filtering, gaussian filtering and binary conversion treatment.
A picture with centrum and vertebral arch is selected manually in software level face view area first as initial lamella to come
Start cutting procedure, then the centrum general profile of the initial lamella of manual drawing is obtained just using Level Set Method by iteration
The centrum precise boundary of beginning lamella.Hereafter cutting procedure will be by starting point of reference layer from upper and lower both direction to all
Lamella carries out cutting operation.
Using the cutting function of software, cutting three-dimensional vertebral model obtains the upper soleplate plane (Fig. 2) of centrum.It is flat in soleplate
The anterior-posterior axle L (Fig. 2) for dividing vertebral model equally into left and right two halves is found on face, measurement anterior-posterior axle L is handed over vertebral model edge two
Distance between point C, D (Fig. 2), obtains centrum sagittal diameter.Measurement and straight line perpendicular anterior-posterior axle L and the intersection point of vertebral rim two
Between distance, wherein the distance between two maximum point A, B (Fig. 2) of distance is the horizontal shape footpath of centrum.On median sagittal plane manually
Obtain front and rear edges point E, F, G, H (Fig. 3) and soleplate central point I, J (Fig. 3) of terminal plate of vertebral body.Above and below measurement before terminal plate of vertebral body
Edge point F, H (Fig. 3) distance obtain intervertenral space leading edge height, and two terminal plate of vertebral body trailing edge point E, G (Fig. 3) distance obtains intervertenral space
Trailing edge height, two soleplate central point I, J (Fig. 3) distance obtains intervertenral space centre-height.
Choose JAGUARTMLUMBAR I/F CAGE (sizes:Height=9mm, wide=9mm, length=25mm, modulus of elasticity:
3600MPa, Poisson's ratio:0.25) as reference model, new Invasive lumbar fusion device is designed according to the horizontal shape footpath of measured centrum
Length, the height of new Invasive lumbar fusion device is set according to disc height.
Double pieces of Invasive lumbar fusion devices are implanted in centrum latter half of.Mesh generation is carried out to model and smooth.Minor articulus is set
Coefficient of friction is 0.1, it is assumed that cancellous bony material is isotropism, and surface-to-surface contact is used between Invasive lumbar fusion device and centrum.L4 vertebras
All frees degree of lower soleplate of body are all fixed, choose the upper soleplate central point R of L3 centrums, downward by applying 400N on R
Pressure simulation centrum load-bearing, apply 10N-m torques simulation it is anteflexion, after stretch, lateral bending, torsion.
Conventional algorithm EBE-PCG (element by element precon- are solved using voxel FEM model
Ditioned conjugate gradient) algorithm solved, and obtains maximum principal stress, and equivalent stress is sunk and displacement,
For evaluating the stress distribution situation and misalignment of centrum and Invasive lumbar fusion device, so that it is determined that whether design is reasonable.For not
Rational design, return to step 4 pair design and modify, and finally realize and both considered geometric match it is further contemplated that function match
The design of personalized Invasive lumbar fusion device.The personalized Invasive lumbar fusion device of final design exports (Fig. 7) with STL forms.
It should be appreciated that only being illustrated rather than to the description that the present invention is carried out in described above and explanation limited
, and on the premise of the present invention limited such as appended claims is not departed from, above-described embodiment can be carried out various
Change, deform, and/or correct.
Drawing reference numeral explanation
101st, IMAQ and pretreatment 102, the segmentation of centrum image and the foundation of threedimensional model
103rd, vertebral model measurement 104, the design and implantation of Invasive lumbar fusion device
105th, FEM meshing and the smooth 106, assignment of material and boundary condition are set
107th, the solution and analysis of FEM model.
Claims (4)
1. a kind of design method of personalized Invasive lumbar fusion device model, it is characterised in that comprise the following steps：
1) IMAQ and pretreatment：Vertebra is subjected to CT scan, the vertebra initial data for then obtaining CT scanner
Image preprocessing is carried out, so as to obtain centrum image；
2) segmentation of centrum image and the foundation of threedimensional model：Select an initial lamella to start cutting procedure manually, paint by hand
The centrum general profile of initial lamella is made, the centrum for then obtaining initial lamella by iteration using Level Set Method is accurately taken turns
Exterior feature, cutting procedure hereafter will carry out cutting operation by starting point of reference layer from upper and lower both direction to all lamellas, adopt
Acquired profile is modified in manual methods, for the result of segmentation, drawn using object plotting method, and in window
Shown in mouthful；
3) centrum threedimensional model is measured：Cutting three-dimensional vertebral model, obtains soleplate plane on vertebral model, is looked in soleplate plane
To anterior-posterior axle of the vertebral model into left and right two halves is divided equally, the distance between anterior-posterior axle and the intersection point of vertebral model edge two is measured, i.e.,
For centrum sagittal diameter, the distance between measurement and the perpendicular intersection point of straight line vertebral model edge two of anterior-posterior axle, wherein distance is maximum
Be the horizontal shape footpath of centrum, the height of intervertenral space measures in vertebral model median sagittal plane, on median sagittal plane manually
The distance for obtaining terminal plate of vertebral body leading edge point above and below the front and rear edges point and soleplate central point of terminal plate of vertebral body, measurement is intervertenral space
Leading edge height, the distance of 2 terminal plate of vertebral body trailing edge points is intervertenral space trailing edge height, and the distance of two soleplate central points is intervertebral
Gap centre-height；
4) design and implantation of Invasive lumbar fusion device model：In existing Invasive lumbar fusion device model library, according to centrum threedimensional model
Upper limb anatomic form, select fusion device model geometry, the height of Invasive lumbar fusion device model is determined according to disc height
Degree, the length and width of Invasive lumbar fusion device model are determined according to centrum transverse diameter, centrum radius vector, make Invasive lumbar fusion device laminating dissection knot
Structure, reaches bigger contact area, according to the quantity of the Invasive lumbar fusion device model of implantation, is implanted into centrum threedimensional model
Different parts, it is for double pieces of Invasive lumbar fusion device models, its symmetrical implantation centrum threedimensional model is latter half of, melt for single piece of intervertebral
Clutch model, centrum threedimensional model center is tiltedly implanted into by it；
5) FEM meshing and smooth：Finite element grid is carried out to centrum threedimensional model and Invasive lumbar fusion device model respectively to draw
Divide and smooth；
6) assignment of material and boundary condition are set：The material properties and boundary condition of centrum threedimensional model each several part are set, led to
Above-mentioned steps are crossed, complete to be implanted with the foundation of the centrum FEM model of Invasive lumbar fusion device model；
7) solution and analysis of FEM model：Centrum FEM model is asked using voxel FEM model derivation algorithm
Solution, solving result is used for evaluating the stress distribution situation and misalignment of centrum threedimensional model and Invasive lumbar fusion device model, so that
It is determined that whether design is reasonable；For irrational design, step 4 is returned to) design to be modified, final realize both considered
Geometric match is it is further contemplated that the design of the personalized Invasive lumbar fusion device model of function match.
2. the design method of personalized Invasive lumbar fusion device model according to claim 1, it is characterised in that 1) described in step
Image preprocessing include medium filtering, gaussian filtering and binary conversion treatment.
3. the design method of personalized Invasive lumbar fusion device model according to claim 1, it is characterised in that 5) described in step
FEM meshing and smooth concrete mode are：Net is carried out to centrum threedimensional model using the Meshing Method based on voxel
Lattice are divided and smooth, and mesh generation is carried out to designed Invasive lumbar fusion device model using the method for mapping.
4. the design method of personalized Invasive lumbar fusion device model according to claim 1, it is characterised in that 7) described in step
Solving result specifically includes maximum principal stress, and equivalent stress is sunk and displacement.
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| US11793577B1 (en) | 2023-01-27 | 2023-10-24 | Carlsmed, Inc. | Techniques to map three-dimensional human anatomy data to two-dimensional human anatomy data |
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| CN102920537A (en) * | 2012-11-01 | 2013-02-13 | 上海理工大学 | Double safety and effectiveness inspection method of human lumbar bone and implant |
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| 人体颈椎有限元建模及仿生颈椎椎间融合器研究;王甲甲;《中国博士学位论文全文数据库工程科技II辑》;20140915(第9期);摘要，第1.4节，第2.4.3节，第3.2节-3.3.2节，第4.4节 * |
| 基于体素的牙种植体及颌骨的有限元建模;蒲放 等;《航天医学与医学工程》;20040630;第17卷(第3期);全文 * |
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