CN106236256A - A kind of manufacture method of personalized Thoracolumbar disk sagittal curvature mould rod - Google Patents
A kind of manufacture method of personalized Thoracolumbar disk sagittal curvature mould rod Download PDFInfo
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- 238000000034 method Methods 0.000 title claims abstract description 22
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
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- 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
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Abstract
The present invention relates to the manufacture method of a kind of personalized Thoracolumbar disk sagittal curvature mould rod, described sagittal curvature mould rod manufacture method is: based on medical image, computer software rebuilds the threedimensional model intending fixed-segment Thoracolumbar disk；Threedimensional model carries out analog reset；In computer software, individuation sagittal curvature mould rod stl file is made according to Thoracolumbar disk sagittal curvature after resetting；Finally utilize 3D to print or other quick molding methods manufacture.Described sagittal curvature mould rod is individuation assisted surgery instrument, and on mould rod, additionally design pedicle screw struts or the index point that pressurizes guarantees to recover vertebral body and the height of intervertebral space while individuation recovers sagittal curvature；Eliminate subjectivity and the blindness of pre-bending pitman in art, decrease C-arm perspective number of times in art；It is applicable to the multiple situations such as lumbar vertebra compression fracture, slippage, intervertebral disc of lumbar vertebra be prominent；Easy and simple to handle, doctor is required relatively low, reduce operation risk, improve procedure efficiency, and then reduce operation cost.
Description
Technical field
The present invention relates to computer aided technique and medical instruments field, particularly relate to a kind of personalized Thoracolumbar disk sagittal bent
The manufacture method of degree mould rod.
Background technology
Lumbar vertebra compression fracture refers to owing to external force causes the successional destruction of Thoracolumbar disk sclerotin.This is that modal spinal column damages
Wound.In between twenty and fifty patient, high-energy damage is its main causative factors of injury, such as traffic accident, high falling wound etc..Gerontal patient due to
Itself there is osteoporosis, causative factors of injury mostly are low violence damage, as slipped, falling.Patients with thoracolumbar fracture often merges god
Through function damage, and owing to causative factors of injury are essentially high-energy injury, often merging other organs damage, this brings greatly for treatment
Difficulty and challenge.
Spinal fracture, slippage, intervertebral disk hernia etc. are the most common.The type disease generally requires operative treatment, treatment
Mesh be that reseting fracture or dislocation are fixing and recover spinal stability and make nerve compression release.Fixing system in posterior Pedicle
Unite by the hold of spinal column three post is implemented fracture and the reset of dislocation, be the first-selected measure processing this type of damage, but breast
The sagittal Curvature change of lumbar vertebra is relatively big, the vertebral height of each patient is also not quite similar, and how in art, individuation recovers it
Normal sagittal curvature and recover and the height of vertebral body (intervertebral space) is the most more stubborn problem.
The most conventional Via Posterior Spinal Approach internal fixation device is GSS pedicle screw system, its afterbody and company after screw lock
Take over the baton vertical, therefore can be adjusted the sagittal curvature of fixed-segment by the radian of pitman, but connect in actual clinical operates
The pre-bending great majority taken over the baton operate by surgical experience, lack objectivity, the most inevitably cause in art
Blindly curved rod makes operating time extend accordingly repeatedly, and postoperative sagittal curvature recovers undesirable.
Summary of the invention
In order to solve above technical problem, the present invention Thoracolumbar disk sagittal curvature mould rod by preoperative analysis personalized designs
Mechanical characteristic under states of physiologic function, it is provided that a kind of a kind of personalized Thoracolumbar disk sagittal curvature mould rod convenient, efficient
Manufacture method, to reach to be effectively improved sagittal curvature and the recovery of vertebral body (intervertebral space) height in operation, it is not necessary to require that surgery is cured
Life accepts special training, so that it may reach to operate fast and accurately, improves safety, reduces operation cost.
Solve personalized Thoracolumbar disk sagittal curvature mould rod of the one in the present invention of above technical problem and preparation method thereof,
It is characterized in that: comprise the following steps:
(1) patient is intended fixed-segment Thoracolumbar disk and carries out CT scan, acquisition DICOM format data:
(2) import data in 3 d modeling software Mimics, rebuild Thoracolumbar disk threedimensional model；
(3) cutting constructing mould is carried out for boundary with fracture or dislocation vertebral body:
Use Mimics software modification to cover the erasing function in cover instrument, dash forward manual into boundary with fracture or dislocation vertebral body lower articular
Separate, i.e. software successively separates its side end to end by hand, then it is different to use region tool for increasing and Boolean calculation to be formed respectively
Cover cover, cover cover with this and set up the threedimensional model of different colours；
Model is one, is easy to reset with different color segmentations, and the number of different color segmentations is 2 or more than 2, the most right
The most permissible in two colors of patient slipped.
(4) sham operated is corrected dislocation and recovers fractured vertebral body height and simulate implantation pedicle screw:
Sham operated in threedimensional model after segmentation, recovers normal sagittal curvature and vertebral body disc height in step (3)；
Enter to follow closely passage with optimal pedicle screw entry point board design pedicle screw；Measure analog Post operation intends fixed-segment breast waist
Vertebra sagittal curvature and need the distance between fixed-segment total length and each sections pedicle screw, and record its numerical value；
After patient for fracturing meets sham operated, fractured vertebral body front and rear edges height is respectively its pleurocentrum front and rear edges end to end
The average of height, meets sham operated backward dislocation for the patient of dislocation and corrects completely and dislocate vertebral body side intervertebral space end to end
Front and rear edges height is respectively it adjacent to normal intervertebral space front and rear edges height.
Above-mentioned threedimensional model is simulated the side of correcting vertebral first by mobile instrument and front and back dislocates, uses and rotate
Instrument, rotates centered by sick vertebra lower articular is prominent respectively, corrects sagittal plane angle, and aforesaid operations is fractured after meeting sham operated
Vertebral body front and rear edges height is respectively the average of its pleurocentrum front and rear edges height end to end, vertebra side intervertebral space front and rear edges end to end of dislocating
Highly it is respectively it adjacent to normal intervertebral space front and rear edges height.
STL formatted file imports reverse engineering software Geomagic, and the three-dimensional reference plane in location, fixed-segment is intended in design
The entry point of vertebral body pedicle of vertebral arch and nail direction, road simulation put nail, intend on fixed-segment pleurocentrum end to end whole before definition sham operated
The angle of plate vertical line is to intend fixed-segment sagittal curvature, then to intend fixed-segment normal sagittal curvature for individuation sagittal curvature mould
The radian of rod, the length strutted for pitman with the mutual distance of the sagittal plain screw line of centres；
(5) sagittal curvature mould rod design:
In software Geomagic, make the mould rod threedimensional model of an a diameter of 6mm with sagittal curvature and length in step (4),
And index point is made on its surface, save as STL formatted file；
(6) incoming 3D printer carries out printing in kind.
In described step (1), Spiral CT scan thickness is 0.625mm, and matrix is 512??512.
Matrix is equivalent to pixel, refers to the pixel that image is 512*512, and thickness is the thinnest, and that brings is the highest, and CT sweeps
The time retouched is the longest.But thickness can not be the thinnest.
In described step (2), bone breaks analog reset concrete operations for selecting threshold value select tool, it is thus achieved that intend fixing Thoracolumbar disk former
Begin to cover cover, then reduce and revise above-mentioned illiteracy cover with region tool for increasing, produce and newly cover cover；Then, this new three-dimensional covering cover is selected to build
Mould also does smoothing processing, obtains the Thoracolumbar disk threedimensional model of required fixed-segment；
In described step (4) sagittal plain screw enter to follow closely upper the soleplate parallel and same vertebral body bilateral pedicle screw of direction and vertebral body with
The vertical dimension of upper soleplate is consistent.
In described step (4), the curvature of sagittal curvature mould rod design intends fixed-segment Thoracolumbar disk sagittal after meeting sham operated
Curvature.
The index point that in described step (5), its surface makes meets the distance that each screw of preoperative planning struts or pressurizes
(distance between each screw).The making of sagittal curvature mould rod need not fit tightly with above-mentioned mark.
In described step (6), the material therefor that prints in kind is photosensitive resin material.Can also use other materials, such as Buddhist nun
Dragon, and the biological nature of nylon is more preferable, can of short duration with human body contact.
In the present invention, personalized sagittal curvature mould rod obtains, with preoperative sham operated, the sagittal curvature ginseng that patient is ideal
Number, is printed as material object by this parameter by the way of 3D prints, by assisting the pre-of pitman in art after this sterilization in kind
Curved, make postoperative patient obtain preferable sagittal curvature.Also obtain ideal pedicle screw and strut height, by this parameter
Be marked at by the way of 3D prints on above-mentioned sagittal curvature mould rod, by after this sterilization in kind in art the strutting of additional screws
And pressurization, the selection implanting pitman total length can also be assisted simultaneously.Mould rod amplitude is with sham operated individuation sagittal curvature
Making, index point distance makes with the distance of sham operated individuation pedicle screw.
The accurate effectiveness for Thoracolumbar disk sagittal curvature mould rod model of geometry is extremely important.Use on this model
Special material is in advance " customized ".It is introduced, Thoracolumbar disk sagittal curvature mould rod state customized have followed primary skeleton anatomical features, protects
Having held function, had personalization, customization advantage, operation wound is little simultaneously.
In the present invention, the manufacture method of personalized Thoracolumbar disk sagittal curvature mould rod, by the CT data before operation in patients, rebuilds
Spinal three-dimensional model, measures related data, and simulation on computers correct for dislocation and recovers patient based on these data
Sagittal curvature, it is thus achieved that the accurately related data of fixed-segment normal sagittal curvature, prints individuation finally by 3D
These data have been implemented in clinical operation by sagittal curvature mould rod and photoelectric navigation system.The pre-bending eliminating pitman is subjective
Property, repeated multiple times operation perspective etc.；Be applicable to spinal fracture, distort, slip, the multiple situation such as pedicle of vertebral arch fracture；It is easy and simple to handle,
Doctor is required relatively low, reduce operation risk, improve procedure efficiency, and then reduce operation cost.An interactive designed
Property sagittal curvature mould rod, the pre-bending of pitman and the recovery of vertebral body (intervertebral space) height in assisted surgery, just recovering vertebral body
Often structure, improves patients ' life quality.
Detailed description of the invention:
In order to be illustrated more clearly that the embodiment of the present invention or technical scheme of the prior art, embodiment will be made simply below
Introduce, it should be apparent that, but patent of the present invention includes being not limited only to the embodiments described below.
Embodiment 1
Fractured vertebral body height and sequence is recovered for more preferable individuation in operation, preoperative by Mimics software
The sham operated function of (Materialise, Switzerland) obtains patient and intends fixed-segment normal vertebral body height and sagittal curvature, simulation
Putting nail and plan operation, the making of its personalized sagittal curvature mould rod specifically comprises the following steps that
(1) patient chest lumbar vertebra is carried out 64 row's Spiral CT scan, acquisition DICOM data:
Pre-operative patients row 64 row's Spiral CT scan checks, thickness is 0.625mm, and matrix is 512??512, with Mimics 14.11
Software imports this original Dicom formatted data.
(2) foundation of threedimensional model and measurement:
First, threshold value select tool (Thresholding) is selected, it is thus achieved that intend original illiteracy of fixing Thoracolumbar disk and cover；Then, favored area increases
Long instrument (Rregion growing), reduces and revises above-mentioned illiteracy cover, produces and newly covers cover；After again, this new three-dimensional covering cover is selected to build
Mould (Calculate 3D from Mask) also does respective smoothed process, and the Thoracolumbar disk finally giving required fixed-segment is three-dimensional
Model；Finally, sick vertebra pleurocentrum height and disc height end to end are accurately measured on this model.
(3) cutting constructing mould is carried out with fracture dislocation vertebral body for boundary:
Using amendment to cover erasing (Erase) function in cover instrument (Edit mask), dashing forward with fracture dislocation vertebral body lower articular is
Boundary is manual separates its side end to end, and deployment area increases technology (Rregion growing) and Boolean calculation (Boolean again
Operations) form 3 new illiteracy covers respectively, cover cover with this and set up the threedimensional model of 3 different colours.
(4) sham operated is corrected dislocation and recovers fractured vertebral body height
Above-mentioned threedimensional model is simulated the side of correcting vertebral first by mobile instrument (Move) and front and back dislocates, uses rotation
Changing a job tool (Rotate), rotate respectively, correct sagittal plane angle centered by sick vertebra lower articular is prominent, aforesaid operations meets simulation
Postop fracture vertebral body front and rear edges height is respectively the average of its pleurocentrum front and rear edges height end to end, vertebra side intervertebral end to end of dislocating
Gap front and rear edges height is respectively it adjacent to normal intervertebral space front and rear edges height.
After sham operated is met for the patient of fracture fractured vertebral body front and rear edges height be respectively its end to end before pleurocentrum,
The average of trailing edge height, meets sham operated backward dislocation for the patient of dislocation and corrects completely and dislocate vertebral body side intervertebral end to end
Gap front and rear edges height is respectively it adjacent to normal intervertebral space front and rear edges height.
Above-mentioned threedimensional model is simulated the side of correcting vertebral first by mobile instrument and front and back dislocates, uses and rotate
Instrument, rotates centered by sick vertebra lower articular is prominent respectively, corrects sagittal plane angle, and aforesaid operations is fractured after meeting sham operated
Vertebral body front and rear edges height is respectively the average of its pleurocentrum front and rear edges height end to end, vertebra side intervertebral space front and rear edges end to end of dislocating
Highly it is respectively it adjacent to normal intervertebral space front and rear edges height.
STL formatted file imports reverse engineering software Geomagic, and the three-dimensional reference plane in location, fixed-segment is intended in design
The entry point of vertebral body pedicle of vertebral arch and nail direction, road simulation put nail, intend on fixed-segment pleurocentrum end to end whole before definition sham operated
The angle of plate vertical line is to intend fixed-segment sagittal curvature, then to intend fixed-segment normal sagittal curvature for individuation sagittal curvature mould
The radian of rod, the length strutted for pitman with the mutual distance of the sagittal plain screw line of centres.
(5) sagittal curvature mould rod design:
In Mimics, derive above-mentioned model with STL form, and import Geomagic Studio 2013 software (Geomagic,
The U.S.) in, the three-dimensional reference plane in location, design is intended the optimal entry point of fixed-segment vertebral body pedicle of vertebral arch and follows closely direction, road and simulate
Put nail, it is desirable to sagittal plain screw enters to follow closely direction soleplate parallel and same vertebral body bilateral pedicle screw upper with vertebral body and upper soleplate
Vertical dimension is consistent.
Intending the angle of soleplate vertical line on fixed-segment pleurocentrum end to end before definition sham operated is fixed-segment sagittal curvature,
Intending the angle of soleplate vertical line on fixed-segment pleurocentrum end to end after sham operated is " intending fixed-segment normal sagittal curvature ".With
" intending fixed-segment normal sagittal curvature " is the radian (curvature) that individuation sagittal curvature mould is excellent, with the sagittal plain screw line of centres
Mutual distance be the length that pitman struts.
(6) incoming 3D printer carries out printing in kind.Material object can be brought into after sterilizing in operation, assisted surgery directly perceived.Real
It is photosensitive resin material that thing prints material therefor.Can also use other materials, such as nylon, and the biological nature of nylon is more
Good, can of short duration with human body contact.
3D prints the making of individuation mould rod: in Geomagic, make an a diameter of 6mm's with above-mentioned radian and length
Threedimensional model, and the index point indicating each screw of preoperative planning to strut distance is made on its surface, save as STL formatted file and pass
Enter 3D printer and carry out 3D material object printing.Design logo point on sagittal mould rod, can objective be controlled by these index points in art
The distance that struts or pressurize of system dislocation vertebral body.Mould rod diameter 6mm, indicates spot diameter 4mm, and mould rod amplitude is with sham operated individuation
Sagittal curvature makes, and index point distance makes with the distance of sham operated individuation pedicle screw.
Personalized sagittal curvature mould rod state have followed primary skeleton anatomical features, maintains bone function, has personalization, determines
Inhibition and generation advantage, operation wound is little simultaneously.
The performance indications of personalized sagittal curvature mould rod are fracture strengths, stress-strain distribution, service life etc..Mechanics
The ratio of the design after analysis is more good simply by virtue of the dummy biomechanical property of Experience Design, uses about more than 20 examples so far
The generation of the bad complication such as patient, observes about 2 years, do not have fracture, exposure, also in further clinical observation.
Test one:
If experimental group and matched group, the content in experimental group concrete operations such as embodiment 1.
Experimental period and object: in May, 2012 in JIUYUE ,-2014,84 example lumbar spondylolisthesis patients are included into research, tradition
PLIF operation group (matched group) 44 example, application 3D prints individuation sagittal curvature mould rod and optical navigation technology row PLIF operation
Group (observation group) 40 example.
The physical data such as the age of two groups of patients, sex, slippage sections, type, lumbago and skelalgia VAS scoring compare, and difference is equal
Not statistically significant (P > 0.05), has comparability.Record two groups of corrective surgery times, intraoperative blood losses.By postoperative image
Data compares two groups of sagittal plane screws and inserts angle, puts nail accuracy rate, slippage rate, disc height recovery rate, fixed-segment sagittal
Curvature recovery rate and lumbago and skelalgia VAS scoring.
Matched group and experimental group operating time are respectively (151.7 ± 19.3), (153.9 ± 17.3) min, and amount of bleeding is respectively
For (625.5 ± 125.0), (610.0 ± 75.0) ml, two groups of comparing difference not statistically significants (P > 0.05)；But matched group is saturating
Secondary depending on number of times and sagittal plane screw placement angle (sagittal screw angle, SSA) respectively (8.5 ± 2.7), (8.5 ±
3.7) °, be significantly higher than experimental group (5.6 ± 1.4) secondary, (2.0 ± 1.8) °, difference statistically significant (P < 0.05)；Put nail standard
Really rate 84.0%(121/144), substantially less than experimental group 91.7%(110/120), difference statistically significant (P < 0.05).Experiment
Organize postoperative immediately, last slippage rate when following up a case by regular visits to, disc height recovery rate, sagittal curvature recovery rate slippage rate be all significantly better than
Matched group, comparing difference is respectively provided with statistical significance (P < 0.05).Postoperative slippage rate immediately, disc height recovery rate, sagittal
The extensive rate of curvature, the scoring of postoperative last lumbago VAS, matched 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 comparing between two groups has
Significant difference (P ＜0.05).
From the above, it can be seen that apply 3D to print individuation sagittal curvature mould rod and optical navigation in lumbar spondylolisthesis posterior approach
Technology, essentially identical relative to traditional operation, intraoperative hemorrhage and operating time, but can preferably correct dislocation and recover sagittal
Curvature, improves Lumbago shape after operation in patients.
The manufacture method of the personalized sagittal curvature mould rod in the present invention is obtained relatively by software sham operated in the preoperative
For sagittal curvature data accurately (measuring with soleplate vertical line in adjacent vertebral bodies), and these data are produced by 3D printer
The sagittal curvature mould rod being of convenient length；In art, pitman selects length and pre-bending can obtain good clinic by above-mentioned mould rod
Result；Additionally this mould rod is simple to operation, and patient can use without accepting special training, can quickly, accurately assist connection
The pre-bending of rod and selection, improve procedure efficiency, reduces operation risk；Manufacture and design based on digitized, it is possible to achieve remotely assist
Helping and design and produce, hospital need not purchase rapidform machine and related software, reduces hospital costs.Can reduce operating time and
Intraoperative hemorrhage, more preferable reseting fracture and dislocation and recovery sagittal curvature, postoperative patient also can obtain more preferable function of nervous system,
Improve Lumbago shape after operation in patients.
Described above to the disclosed embodiments, makes those skilled in the art be capable of or uses the present invention.To this
The multiple amendment of a little embodiments will be apparent from for those skilled in the art, as defined herein typically
Principle can realize without departing from the spirit or scope of the present invention in other embodiments.Therefore, the present invention will not
Can be intended to be limited to the embodiments shown herein, and be to fit to consistent with principles disclosed herein and features of novelty
The widest scope.
Claims (7)
1. the manufacture method of a personalized Thoracolumbar disk sagittal curvature mould rod, it is characterised in that: comprise the following steps:
(1) patient is intended fixed-segment Thoracolumbar disk and carries out CT scan, acquisition DICOM format data:
(2) import data in 3 d modeling software Mimics, rebuild Thoracolumbar disk threedimensional model；
(3) cutting constructing mould is carried out for boundary with fracture or dislocation vertebral body:
Use Mimics software modification to cover the erasing function in cover instrument, dash forward manual into boundary with fracture or dislocation vertebral body lower articular
Separate its side end to end, then use region tool for increasing and Boolean calculation to form different illiteracy covers respectively, cover cover with this and set up difference
The threedimensional model of color；
(4) sham operated is corrected dislocation and recovers fractured vertebral body height and simulate implantation pedicle screw:
Sham operated in threedimensional model after segmentation, recovers normal sagittal curvature and vertebral body disc height in step (3),
Entering to follow closely passage with pedicle screw entry point board design pedicle screw, measure analog Post operation is intended fixed-segment Thoracolumbar disk and is vowed
Shape curvature, need the distance between fixed-segment total length and each sections pedicle screw, and record its numerical value；
(5) sagittal curvature mould rod design:
In software Geomagic, make mould rod threedimensional model with sagittal curvature in step (4) and length, and make on its surface
Index point, saves as STL formatted file；
(6) incoming 3D printer carries out printing in kind.
2. according to the manufacture method of a kind of personalized Thoracolumbar disk sagittal curvature mould rod described in claim 1, it is characterised in that:
In described step (1), Spiral CT scan thickness is 0.625mm, and matrix is 512??512.
3. according to the manufacture method of a kind of personalized Thoracolumbar disk sagittal curvature mould rod described in claim 1, it is characterised in that:
In described step (2), bone breaks analog reset concrete operations for selecting threshold value select tool, it is thus achieved that intend the original cover that covers of fixing Thoracolumbar disk, then
Reduce and revise above-mentioned illiteracy cover with region tool for increasing, produce and newly cover cover；Then, select this new three-dimensional modeling covering cover and do smooth
Process, obtain the Thoracolumbar disk threedimensional model of required fixed-segment.
4. according to the manufacture method of a kind of personalized Thoracolumbar disk sagittal curvature mould rod described in claim 1, it is characterised in that:
In described step (4), sagittal plain screw entered to follow closely direction soleplate parallel and same vertebral body bilateral pedicle screw upper with vertebral body and upper end
The vertical dimension of plate is consistent.
5. according to the manufacture method of a kind of personalized Thoracolumbar disk sagittal curvature mould rod described in claim 5, it is characterised in that:
The curvature that in described step (4), sagittal curvature mould rod designs meets patient and intends fixed-segment normal sagittal curvature.
6., according to the manufacture method of 1 described in claim a kind personalized Thoracolumbar disk sagittal curvature mould rod, its feature exists
In: the index point that in described step (5), its surface makes meets the distance that each screw of preoperative planning struts or pressurizes.
7. according to the manufacture method of a kind of personalized Thoracolumbar disk sagittal curvature mould rod described in claim 1, it is characterised in that:
In described step (6), the material therefor that prints in kind is photosensitive resin material.
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