CN106236256B - A kind of production method of personalization Thoracolumbar disk sagittal curvature mould stick - Google Patents
A kind of production method of personalization Thoracolumbar disk sagittal curvature mould stick Download PDFInfo
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- CN106236256B CN106236256B CN201510724642.0A CN201510724642A CN106236256B CN 106236256 B CN106236256 B CN 106236256B CN 201510724642 A CN201510724642 A CN 201510724642A CN 106236256 B CN106236256 B CN 106236256B
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00526—Methods of manufacturing
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Abstract
The present invention relates to a kind of production method of personalized Thoracolumbar disk sagittal curvature mould stick, the sagittal curvature mould stick production method is：Based on medical image, computer software rebuilds the threedimensional model for intending fixed-segment Thoracolumbar disk；Analog reset is carried out on threedimensional model；Individuation sagittal curvature mould stick stl files are made in computer software according to Thoracolumbar disk sagittal curvature after reset；Finally manufactured using 3D printing or other quick molding methods.The sagittal curvature mould stick assists operation tool for individuation, restores the height of centrum and intervertenral space while index point is ensured in individuation recovery sagittal curvature in addition designing pedicle screw on mould stick and strutting or pressurize；The subjectivity and blindness of pre-bending pitman in art are eliminated, reduces C-arm in art and has an X-rayed number；Suitable for a variety of situations such as thoracolumbar fracture, slippage, intervertebral disc of lumbar vertebra protrusions；It is easy to operate, relatively low, reduction operation risk is required doctor, improves procedure efficiency, and then reduction operation cost.
Description
Technical field
The present invention relates to computer aided technique and medical instruments field more particularly to a kind of personalized Thoracolumbar disk sagittal are bent
Spend the production method of mould stick.
Background technology
Thoracolumbar fracture refers to cause the successional destruction of Thoracolumbar disk sclerotin due to external force.This is most common backbone damage
Wound.In between twenty and fifty patient, high-energy damage is its main Risk Factors, such as traffic accident, high falling wound etc..Gerontal patient due to
, there are osteoporosis, Risk Factors are mostly low violence damage, such as slip, fall for itself.Patients with thoracolumbar fracture often merges god
Through function damage, and since Risk Factors are essentially high-energy injury, often merge other organs damage, this brings greatly for treatment
Difficulty and challenge.
Spine fracture, slippage, disc herniation etc. are clinically common.The type disease generally requires operative treatment, treatment
Mesh be that reseting fracture or dislocation are fixed and restore spinal stability and release nerve compression.Fixed system in posterior Pedicle
System is the preferred measure for handling such damage by implementing the reset to fracturing and dislocating to the hold of three column of backbone, but chest
The sagittal Curvature change of lumbar vertebrae is larger, each patient vertebral height is also not quite similar, how in art individuation restores it
Normal sagittal curvature and recovery and centrum（Intervertenral space）Height be clinically more stubborn problem.
Currently used Via Posterior Spinal Approach internal fixation device is GSS pedicle screw systems, its tail portion and company after screw lock
It takes over the baton vertical, therefore the sagittal curvature of fixed-segment can be adjusted by the radian of pitman, but connect in actual clinical operation
Most of pre-bending taken over the baton is operated by surgical experience, is lacked objectivity, is inevitably caused in art in this way
Blindness curved rod makes operating time accordingly extend repeatedly, and postoperative sagittal curvature restores undesirable.
Invention content
In order to solve the above technical problems, Thoracolumbar disk sagittal curvature mould stick of the present invention by preoperative analysis personalized designs
Mechanical characteristic under states of physiologic function provides a kind of a kind of convenient, efficient personalized Thoracolumbar disk sagittal curvature mould stick
Production method effectively improves sagittal curvature and centrum in operation to reach（Intervertenral space）The recovery of height, without surgery is required to cure
Life receives special training, so that it may reach and fast and accurately operate, improve safety, reduce operation cost.
A kind of personalized Thoracolumbar disk sagittal curvature mould stick in the present invention of solution more than technical problem and preparation method thereof,
It is characterized in that：Include the following steps：
（1）Fixed-segment Thoracolumbar disk is intended to patient and carries out CT scan, obtains DICOM format data：
（2）It imports data in 3 d modeling software Mimics, rebuilds Thoracolumbar disk threedimensional model；
（3）To fracture or dislocate, centrum is split modeling as boundary：
The erasing function in cover tool is covered using Mimics software modifications, centrum lower articular is dashed forward as boundary to fracture or dislocate
Separation by hand successively detaches its side end to end, then be respectively formed not using region tool for increasing and Boolean calculation by hand that is, in software
With illiteracy cover, the threedimensional model that cover establishes different colours is covered with this；
Model is one, and with different color segmentations convenient for resetting, the number of different color segmentations is 2 or more than 2, than
It such as can for two colors of the patient of slippage.
（4）Simulation operation corrects dislocation and restores fractured vertebral body height and simulate implantation pedicle screw：
In step（3）Operation is simulated in threedimensional model after middle segmentation, restores normal sagittal curvature and centrum intervertenral space
Highly；With best pedicle screw entry point board design pedicle screw into nail channel；Intend fixed knot after measuring simulation operation
Section and needs the distance between fixed-segment total length and each segment pedicle screw, and record its number at Thoracolumbar disk sagittal curvature
Value；
For the patient of fracture meet simulation postop fracture centrum front and rear edges height be respectively its end to end before pleurocentrum,
The mean value of rear height meets simulation operation backward dislocation correction and dislocation centrum completely side intervertebral end to end for the patient of dislocation
Gap front and rear edges height is respectively it adjacent to normal intervertenral space front and rear edges height.
The side of correcting vertebral and front and rear dislocation are simulated using mobile tool first in above-mentioned threedimensional model, uses rotation
Tool, respectively by sick vertebra lower articular dash forward centered on rotate, correct sagittal plane angle, aforesaid operations meet simulation postop fracture
Centrum front and rear edges height is respectively the mean value of its pleurocentrum front and rear edges height end to end, dislocation vertebra side intervertenral space front and rear edges end to end
Highly be respectively its adjacent to normal intervertenral space front and rear edges height.
STL formatted files are imported into reverse engineering software Geomagic, position three-dimensional reference planes, fixed-segment is intended in design
The entry point of centrum pedicle of vertebral arch and screw way direction simultaneously simulate and put nail, and it is whole on pleurocentrum end to end that definition simulation operation consent intends fixed-segment
The angle of plate vertical line is to intend fixed-segment sagittal curvature, then to intend the normal sagittal curvature of fixed-segment as individuation sagittal curvature mould
The radian of stick, using the mutual distance of the sagittal plain screw line of centres as the distracted length of pitman；
（5）Sagittal curvature mould stick designs：
In software Geomagic, with step（4）Middle sagittal curvature and length make the mould stick three-dimensional mould of an a diameter of 6mm
Type, and index point is made on its surface, save as STL formatted files；
（6）Incoming 3D printer carries out printing in kind.
The step（1）Middle CT scan thickness be 0.625mm, matrix 512512.
Matrix is equivalent to pixel, refers to the pixel that image is 512*512, and thickness is thinner, and that brings is accurate higher, and CT is swept
The time retouched is longer.But thickness can not be too thin.
The step（2）Middle bone breaks analog reset concrete operations to select threshold value select tool, obtains and intends fixed Thoracolumbar disk original
Begin to cover cover, then reduced with region tool for increasing and change above-mentioned illiteracy cover, generate and newly cover cover；Then, this new three-dimensional for covering cover is selected to build
Mould simultaneously makees Thoracolumbar disk threedimensional model of the smoothing processing to get required fixed-segment；
The step（4）Middle sagittal plain screw goes up that soleplate is parallel and same centrum bilateral pedicle of vertebral arch screw into nail direction and centrum
Nail is consistent with the vertical range of upper soleplate.
The step（4）The curvature of middle sagittal curvature mould stick design intends fixed-segment Thoracolumbar disk sagittal after meeting simulation operation
Curvature.
The step（5）In its surface make index point meet the distance that each screw of preoperative planning struts or pressurizes
（The distance between each screw）.The making of sagittal curvature mould stick does not need to fit closely with above-mentioned mark.
The step（6）Middle printing material therefor in kind is photosensitive resin material.Other materials, such as Buddhist nun can also be used
Dragon, and the biological nature of nylon is more preferable, it can be with the of short duration contact of human body.
Personalized sagittal curvature mould stick obtains the ideal sagittal curvature ginseng of patient with preoperative simulation operation in the present invention
Number, material object is printed as by this parameter by way of 3D printing, by assisting the pre- of pitman in art after this material object disinfection
It is curved, postoperative patient is made to obtain ideal sagittal curvature.Also it obtains ideal pedicle screw and struts height, by this parameter
It is marked by way of 3D printing on above-mentioned sagittal curvature mould stick, by the way that additional screws strut in art after this material object disinfection
And pressurization, while the selection of implantation pitman total length can also be assisted.Mould stick amplitude is to simulate surgery individual sagittal curvature
It makes, index point distance is made with simulating the distance of surgery individual pedicle screw.
The accurate validity for Thoracolumbar disk sagittal curvature mould stick model of geometry is extremely important.It uses on this model
Special material shifts to an earlier date " customized ".It is introduced that Thoracolumbar disk sagittal curvature mould stick state customized has followed primary skeleton anatomical features, protect
Function has been held, there is personalized, customization advantage, while operation wound is small.
The production method of personalized Thoracolumbar disk sagittal curvature mould stick in the present invention, by the preoperative CT data of patient, rebuilds
Spinal three-dimensional model measures related data, and simulation on computers corrects for dislocation and restores patient based on this data
Sagittal curvature obtains the related data of the normal sagittal curvature of accurate fixed-segment, finally by 3D printing individuation
Sagittal curvature mould stick and photoelectric navigation system have implemented to these data in clinical operation.The pre-bending for eliminating pitman is subjective
Property, repeated multiple times operation perspective etc.；Suitable for a variety of situations such as spine fracture, distortion, slippage, pedicle of vertebral arch fractures；It is easy to operate,
Relatively low, reduction operation risk is required doctor, improves procedure efficiency, and then reduction operation cost.The interactive designed
Property sagittal curvature mould stick, auxiliary operation in pitman pre-bending and centrum（Intervertenral space）The recovery of height is restoring centrum just
Normal structure improves patients ' life quality.
Specific embodiment：
In order to illustrate more clearly about the embodiment of the present invention or technical scheme of the prior art, letter will be made to embodiment below
Singly introduce, it should be apparent that, patent of the present invention includes but is not limited only to the embodiments described below.
Embodiment 1
Restore fractured vertebral body height and sequence for individuation better in operation, it is preoperative to pass through Mimics softwares
The simulation surgical functions of (Materialise, Switzerland) obtain patient and intend fixed-segment normal vertebral body height and sagittal curvature, simulation
It puts nail and plans operation, the making of personalized sagittal curvature mould stick is as follows：
（1）64 row's CT scans are carried out to patient's Thoracolumbar disk, obtain DICOM data：
The 64 row's CT scan inspection of pre-operative patients row, thickness 0.625mm, matrix 512512, use Mimics
14.11 softwares import this original Dicom formatted data.
（2）The foundation and measurement of threedimensional model：
First, threshold value select tool (Thresholding) is selected, obtains and intends the original illiteracy cover of fixed Thoracolumbar disk；Then, constituency
Domain tool for increasing (Rregion growing) reduces and changes above-mentioned illiteracy cover, generates new cover and covers；After again, the three of this new illiteracy cover is selected
Dimension modeling (Calculate 3D from Mask) simultaneously does respective smoothed processing, finally obtains the Thoracolumbar disk of required fixed-segment
Threedimensional model；Finally, it is accurate on this model to measure sick vertebra pleurocentrum height and disc height end to end.
（3）Modeling is split by boundary of fracture dislocation centrum：
Cover tool is covered using modification（Edit mask）In erasing（Erase）Function, with fracture dislocation centrum lower articular
It dashes forward and detaches its side end to end by hand for boundary, again with region growth technique (Rregion growing) and Boolean calculation
（Boolean Operations）3 new illiteracy covers are respectively formed, the threedimensional model that cover establishes 3 different colours is covered with this.
（4）Simulation operation corrects dislocation and restores fractured vertebral body height
First using mobile tool in above-mentioned threedimensional model（Move）The side of correcting vertebral and front and rear dislocation are simulated, is made
With rotation tool（Rotate）, respectively by sick vertebra lower articular dash forward centered on rotate, correct sagittal plane angle, aforesaid operations meet
Simulation postop fracture centrum front and rear edges height is respectively the mean value of its pleurocentrum front and rear edges height end to end, dislocation vertebra side end to end
Intervertenral space front and rear edges height is respectively it adjacent to normal intervertenral space front and rear edges height.
For the patient of fracture meet simulation postop fracture centrum front and rear edges height be respectively its end to end before pleurocentrum,
The mean value of rear height meets simulation operation backward dislocation correction and dislocation centrum completely side intervertebral end to end for the patient of dislocation
Gap front and rear edges height is respectively it adjacent to normal intervertenral space front and rear edges height.
The side of correcting vertebral and front and rear dislocation are simulated using mobile tool first in above-mentioned threedimensional model, uses rotation
Tool, respectively by sick vertebra lower articular dash forward centered on rotate, correct sagittal plane angle, aforesaid operations meet simulation postop fracture
Centrum front and rear edges height is respectively the mean value of its pleurocentrum front and rear edges height end to end, dislocation vertebra side intervertenral space front and rear edges end to end
Highly be respectively its adjacent to normal intervertenral space front and rear edges height.
STL formatted files are imported into reverse engineering software Geomagic, position three-dimensional reference planes, fixed-segment is intended in design
The entry point of centrum pedicle of vertebral arch and screw way direction simultaneously simulate and put nail, and it is whole on pleurocentrum end to end that definition simulation operation consent intends fixed-segment
The angle of plate vertical line is to intend fixed-segment sagittal curvature, then to intend the normal sagittal curvature of fixed-segment as individuation sagittal curvature mould
The radian of stick, using the mutual distance of the sagittal plain screw line of centres as the distracted length of pitman.
（5）Sagittal curvature mould stick designs：
Above-mentioned model is exported in Mimics with STL forms, and imports 2013 softwares of Geomagic Studio
（Geomagic, the U.S.）In, three-dimensional reference planes are positioned, the best entry point and screw way of fixed-segment centrum pedicle of vertebral arch are intended in design
It simultaneously simulates and puts nail in direction, it is desirable that sagittal plain screw goes up that soleplate is parallel and same centrum bilateral pedicle screw into nail direction and centrum
It is consistent with the vertical range of upper soleplate.
Definition simulation operation consent intends fixed-segment, and the angle of soleplate vertical line is fixed-segment sagittal curvature on pleurocentrum end to end,
Intending fixed-segment after simulation operation, the angle of soleplate vertical line is " intending the normal sagittal curvature of fixed-segment " on pleurocentrum end to end.With
" intending the normal sagittal curvature of fixed-segment " is the radian of individuation sagittal curvature mould stick（Curvature）, with the sagittal plain screw line of centres
Mutual distance be the distracted length of pitman.
（6）Incoming 3D printer carries out printing in kind.Material object is brought into after can sterilizing in operation, intuitive auxiliary operation.It is real
Object printing material therefor is photosensitive resin material.Other materials, such as nylon can also be used, and the biological nature of nylon is more
It is good, it can be with the of short duration contact of human body.
The making of 3D printing individuation mould stick：In Geomagic, make an a diameter of 6mm's with above-mentioned radian and length
Threedimensional model, and the index point that the preoperative each screw of planning of instruction struts distance is made on its surface, save as STL formatted files biography
Enter 3D printer and carry out 3D material object printings.The design logo point on sagittal mould stick objective can be controlled by these index points in art
The distance that struts or pressurize of system dislocation centrum.Mould stick diameter 6mm, indicates spot diameter 4mm, and mould stick amplitude is to simulate surgery individual
Sagittal curvature makes, and index point distance is made with simulating the distance of surgery individual pedicle screw.
Personalized sagittal curvature mould stick state has followed primary skeleton anatomical features, maintains bone function, and it is personalized, fixed to have
Inhibition and generation advantage, while operation wound is small.
The performance indicator of personalized sagittal curvature mould stick is fracture strength, stress-strain distribution, service life etc..Mechanics
The dummy biomechanical property of the ratio of design after analysis simply by virtue of Experience Design is better, uses about more than 20 examples so far
Patient observes about 2 years, does not have the generation of the bad complication such as fracture, exposure, also in further clinical observation.
Experiment one：
If experimental group and control group, the content in experimental group concrete operations such as embodiment 1.
Experimental period and object：In May, 2012 in September, -2014,84 lumber spondylolisthesis patients are included into research, tradition
PLIF operations group (control group) 44 is performed the operation using 3D printing individuation sagittal curvature mould stick and optical navigation technology row PLIF
Group (observation group) 40.
The general information such as age, gender, slippage segment, type, the pain in waist and lower extremities VAS scorings of two groups of patients compare, and difference is equal
It is not statistically significant（P>0.05）, it is comparable.Record two groups of corrective surgery times, intraoperative blood losses.Pass through postoperative image
Data compares two groups of sagittal plane screw merging angles, puts nail accuracy rate, slippage rate, disc height recovery rate, fixed-segment sagittal
Curvature recovery rate and pain in waist and lower extremities VAS scorings.
Control group and experimental group operating time are respectively（151.7±19.3）、（153.9±17.3）Min, amount of bleeding difference
For（625.5±125.0）、（610.0±75.0）Ml, two groups of comparing differences are not statistically significant（P>0.05）；But control group is saturating
Depending on number and sagittal plane screw placement angle（Sagittal screw angle, SSA）Respectively（8.5±2.7）Secondary,（8.5±
3.7）°, it is significantly higher than experimental group（5.6±1.4）Secondary,（2.0±1.8）°, difference is statistically significant（P<0.05）；It is accurate to put nail
True rate 84.0%（121/144）, substantially less than experimental group 91.7%（110/120）, difference is statistically significant（P<0.05）.Experiment
Group is postoperative immediately, last follow-up when slippage rate, disc height recovery rate, sagittal curvature recovery rate slippage rate be significantly better than
Control group, comparing difference are respectively provided with statistical significance（P<0.05）.The postoperative rate of slippage immediately, disc height recovery rate, sagittal
The extensive rate of curvature, postoperative last pain in the back VAS scorings, control group is respectively 9.1 ± 3.2%, 80.8 ± 3.2%, 82.5 ± 7.9% and 3.7
± 2.5 points, experimental group is respectively 3.1 ± 1.5%, 92.7 ± 7.2% and 93.9 ± 4.9% and 1.2 ± 1.1 points, and two comparison among groups have
Significant difference（P ＜0.05）.
From the above, it can be seen that 3D printing individuation sagittal curvature mould stick and photoelectricity are applied in lumber spondylolisthesis posterior approach
Airmanship, relative to traditional operation, intraoperative hemorrhage and operating time are essentially identical, but can preferably correct dislocation and recovery
Sagittal curvature improves patient's Lumbar pain after operation symptom.
The production method of personalized sagittal curvature mould stick in the present invention in the preoperative by software simulation operation obtain compared with
For accurate sagittal curvature data（It is measured with soleplate vertical line in adjacent vertebral）, and this data is produced by 3D printer
The sagittal curvature mould stick that is of convenient length；Pitman selects length and pre-bending that can obtain good clinic by above-mentioned mould stick in art
As a result；In addition this mould stick is simple to operate, and patient, which need not receive special training, to be used, and quickly, accurately can assist connecting
The pre-bending and selection of stick improve procedure efficiency, reduce operation risk；Based on digitized design and manufacture, long-range association can be realized
It helps and designs and produces, hospital need not purchase rapidform machine and related software, reduce hospital costs.Can reduce operating time and
Intraoperative hemorrhage, better reseting fracture and dislocation and recovery sagittal curvature, postoperative patient can also obtain better nervous function,
Improve patient's Lumbar pain after operation symptom.
The foregoing description of the disclosed embodiments enables those skilled in the art to realize or use the present invention.To this
A variety of modifications of a little embodiments will be apparent for those skilled in the art, as defined herein general
Principle can be realized in other embodiments without departing from the spirit or scope of the present invention.Therefore, the present invention will not
It can be intended to be limited to the embodiments shown herein, and be to fit to consistent with the principles and novel features disclosed herein
Most wide range.
Claims (3)
1. a kind of production method of personalization Thoracolumbar disk sagittal curvature mould stick, it is characterised in that：Include the following steps：
（1）Fixed-segment Thoracolumbar disk is intended to patient and carries out CT scan, obtains DICOM format data：
（2）It imports data in 3 d modeling software Mimics, rebuilds Thoracolumbar disk threedimensional model；
（3）To fracture or dislocate, centrum is split modeling as boundary：
The erasing function in cover tool is covered using Mimics software modifications, is dashed forward with centrum lower articular of fracturing or dislocate as boundary's craft
Its side end to end is detached, then different illiteracy covers is respectively formed using region tool for increasing and Boolean calculation, cover is covered with this and establishes difference
The threedimensional model of color；
（4）Simulation operation corrects dislocation and restores fractured vertebral body height and simulate implantation pedicle screw：
In step（3）Operation is simulated in threedimensional model after middle segmentation, restores normal sagittal curvature and centrum disc height,
With pedicle screw entry point board design pedicle screw into nail channel, intend fixed-segment Thoracolumbar disk arrow after measuring simulation operation
Shape curvature needs the distance between fixed-segment total length and each segment pedicle screw, and records its numerical value；For fracture
Patient meets the mean value that simulation postop fracture centrum front and rear edges height is respectively its pleurocentrum front and rear edges height end to end, right
Meet simulation operation backward dislocation correction and dislocation centrum completely side intervertenral space front and rear edges height point end to end in the patient of dislocation
Not Wei its adjacent to normal intervertenral space front and rear edges height；
（5）Sagittal curvature mould stick designs：
In software Geomagic, with step（4）Middle sagittal curvature and length make mould stick threedimensional model, and are made on its surface
Index point, the index point that surface makes meet the distance that each screw of preoperative planning struts or pressurizes, and save as STL forms text
Part；
（6）Incoming 3D printer carries out printing in kind；
The step（2）Middle threedimensional model establishes concrete operations to select threshold value select tool, and it is original to obtain the fixed Thoracolumbar disk of plan
Cover is covered, then is reduced with region tool for increasing and changes above-mentioned illiteracy cover, generates new illiteracy cover；Then, this new three-dimensional modeling for covering cover is selected
And make Thoracolumbar disk threedimensional model of the smoothing processing to get required fixed-segment；
The step（4）Middle sagittal plain screw is parallel into the upper soleplate of nail direction and centrum and same centrum bilateral pedicle screw and
The vertical range of upper soleplate is consistent.
2. according to a kind of production method of personalized Thoracolumbar disk sagittal curvature mould stick described in claim 1, it is characterised in that：
The step（1）Middle CT scan thickness is 0.625mm, matrix 512*512.
3. according to a kind of production method of personalized Thoracolumbar disk sagittal curvature mould stick described in claim 1, it is characterised in that：
The step（6）Middle printing material therefor in kind is photosensitive resin material.
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| US10869722B2 (en) | 2016-11-02 | 2020-12-22 | Rochester Institute Of Technology | Method and fixture for guided pedicle screw placement |
| CN109124763B (en) * | 2018-09-20 | 2020-09-08 | 创辉医疗器械江苏有限公司 | Personalized spinal column orthopedic rod and manufacturing method thereof |
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