CN103099669B - Single-side pedicle screw-driving auxiliary device and manufacturing method thereof - Google Patents
Single-side pedicle screw-driving auxiliary device and manufacturing method thereof Download PDFInfo
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Abstract
The invention relates to a single-side pedicle screw-driving auxiliary device and a manufacturing method thereof. The device comprises a guide hole, a sleeve, a first clamping piece, a second clamping piece, a cross shaft and a torsion spring. The invention also discloses the manufacturing method of the device. The manufacturing method comprises the following steps of: firstly, acquiring three-dimensional data of a vertebral body through CT (computed tomography) scanning, and three-dimensionally constructing a three-dimensional model of the vertebral body; secondly, fitting the clamping pieces which are complementary with anatomic form curved surfaces of a cone plate and an acantha by using engineering software; and finally, producing the device by using a rapid forming technology. The single-side pedicle screw-driving auxiliary device has the beneficial effects of being convenient and simple to use, shortening the average operation time, improving the efficiency, reducing the risk of exposure infection, avoiding traction injuries to surrounding tissues, and the like.
Description
Technical field
The present invention relates to medical instruments field, be specifically related to, a kind of one-sided pedicle screw enters to follow closely auxiliary device and preparation method thereof, described in enter to follow closely auxiliary device be utilize prepare from Computer-aided Design Technology, reverse Engineering Technology and rapid shaping technique.
Background technology
Along with renewal and the development of technology, pedicle screw internal fixation technology is applied to spinal column degeneration gradually, slippage, spinal canal stenosis, vertebral fracture, deformity, metastatic tumor of bone, among the operative treatment of the spinal diseases such as spinal instability, the development and progress for spinal surgery serves indelible effect.
Biomechanics experiment proves, screw is only had accurately to insert along the dissection major axis passage that pedicle of vertebral arch is unique and reach depth desired, the stability of guarantee nail-stick system and desirable clinical efficacy [LAW M, TENCERA F, ANDERSON P A.Caudo-cephalad loading of pedicle screws:mechanisms of loosening and methods of augmentation.Spine, 1993,18 (16): 2438-2443], this uniqueness causes the operation easier making operation to increase.For improving the accuracy inserted of pedicle screw, Chinese scholars to entering to follow closely position, angle, the degree of depth carried out a lot of correlational study.This type of research makes doctor recognize, and the larger variability of pedicle of vertebral arch its own shape existence puts nail fault rate one of unsafty most important reason all the time.
Pedicle screw internal fixation technological core be insert screw must according to pedicle of vertebral arch long axis ray by this narrow and small bone pipeline, and make screw under the prerequisite not passing pedicle of vertebral arch cortex, radius is large as far as possible, so both can avoid accidentally injuring vital tissue structure around, the intensity of internal fixtion can have been ensured again simultaneously.Therefore, what the key problem in technology of pedicle screw internal fixtion was screw enters to follow closely position, direction and the degree of depth.
Nail method of putting conventional at present mainly contains: anatomic landmark point method, vertebral lamina fenestration method, X-ray examination auxiliary law, computer assisted navigation method etc.Although various anatomic landmark point method entry point, to enter to follow closely angle different.But their common feature is the entry point of pedicle screw, enter to follow closely direction to judge mainly through the experience of patient, the feeling of the main dependence feel of patient and the opposed nail passage of pedicle of vertebral arch probe ensures accurately inserting of pedicle screw, correlational study is reported, the screw misplace rate of anatomic landmark point method is at about 20%-30% [SCHULZE C J, MUNZINGER E, WEBER U.Clinical relevance of accuracy of pedicle screw placement.A computed tomographic-supported analysis.Spine, 1998, 23 (20): 2215-20], even can up to 40% [REICHLE E in thoracic pedicle screw misplace rate, SELLENSCHLOH K, MORLOCK M, et al.Placement of pedicle screws using different navigation systems.A laboratory trial with 12 spinal preparations.DER
2002,31 (4): 368-371].The accuracy and safety use that can improve and put nail is inserted by carrying out pedicle screw under the direct-view of part vertebrae plate resection.But this method is higher to the skill requirement of patient equally, vertebral lamina fenestration inevitably increases operating time and intraoperative blood loss simultaneously.It is long to there is operation time in X-ray examination auxiliary law, the deficiencies such as x-ray radiation amount is larger are subject in patient and operator art, and because of vertebral body skeleton complex contour, the existence of X-ray examination angle difference and artifact, there is very high false positive rate and false negative rate, Weinstein [WEINSTEIN J N, SPRATT K F, SPENGLER D, et al.Spinal pedicle fixation:reliability and validity of roentgenogram-based assessment and surgical factors on successful screw placement.Spine, 1988, 13 (9): 1012-1018] accuracy that dissec pedicle screw is inserted is researched and analysed, find that there is 21% wear out pedicle of vertebral arch cortex.Illustrate that this kind is put the in fact very difficult raising of nail method and once put nail success rate.
In recent years, computer assisted navigation method starts to obtain application gradually in pedicle of lumbar vertebral arch screw internal fixtion, the pedicle of vertebral arch iconography information that the method makes patient that patient can be utilized instant carrys out real-time instruction operation, forward-looking, real-time, insert technical elements instructing pedicle screw and obtain huge success, relevant report shows, the misplace rate that appliance computer assisting navigation technology puts nail can obviously decline, reduce the risk of nerve injury, decrease the time of doctor and patient contact ray, there is the unrivaled advantage of additive method.But vertebral arch pedicle of vertebral column positioning navigating device is expensive, higher to devices call, learning cycle is long, easily produces error during conical surface registration, therefore, still need inquire into further have simple and convenient, science is reliable, accuracy is high, the advantage such as practical put nail method.
Result of study display [Suk KS previously, Lee HM, Kim NH, et al.Unilateral versus bilateral pedicle screw fixation in lumbar spinal fusion.Spine (Phila Pa 1976), 2000, 25 (14): 1843-1847.] when carrying out pedicle screw and fixing, adopt one-sided and that bilateral is fixing effect no significant difference, but adopt one-sided fixing time operation wound relatively little, intraoperative blood loss is less, and patient's post-operative recovery is very fast, hospital stays is shorter, required medical expense is less.So other needs the disease of side Lumbar Fusion in treatment prolapse of lumbar intervertebral disc etc., one-sided pedicle screw internal fixation has advantage more better than bilateral pedicle screw internal fixation.
Summary of the invention
For solving the problem of one-sided pedicle screw internal fixation accuracy, the invention discloses a kind of one-sided pedicle screw and entering to follow closely auxiliary device and preparation method thereof and lead to, described enter to follow closely auxiliary device easy to use, and effectively can improve pedicle of vertebral arch and implant accuracy rate.
Above-mentionedly enter to follow closely auxiliary device and comprise: pilot hole, sleeve pipe, the first intermediate plate, the second intermediate plate, transverse axis, torsionspring, wherein pilot hole is connected with bottom the first intermediate plate, first intermediate plate and the second middle part pressed from both sides have brace, brace has hole, and transverse axis is successively through the hole of the hole of the first intermediate plate brace, torsionspring and the second intermediate plate.Angle [alpha] between first intermediate plate and the second intermediate plate preferably 25 ° ~ 65 °.
Sleeve pipe comprises union body and casing head, and casing head is directly connected with union body, and the hole wherein on casing head communicates with the internal diameter of union body internal gutter.Described union body inserts in pilot hole, and wherein union body external diameter is identical with the diameter length of pilot hole internal diameter, and the internal diameter of union body has different size, described union body internal diameter preferably 0.5 ~ 20mm.When changing the pedicle screw screw tap of Kirschner wire and different size in operation process, change the sleeve pipe mated with it accordingly, the external diameter of the pedicle screw screw tap of the internal diameter of described coupling fingerstall body and Kirschner wire and different size is equal.Its effect of described sleeve pipe assists the pedicle screw screw tap of Kirschner wire and different size through vertebral body more accurately.
First the present invention applies Pro/E Wildfire 4.0 individuation designed containing the one-sided pedicle of vertebral arch positioning guide hole of single vertebral body on the lumbar vertebra Digital anatomy model of three-dimensional reconstruction and enters to follow closely auxiliary device, then by laser successively curing molding technology of irradiating, template is produced, when clinical practice, template and corresponding lumbar vertebra rear portion bone anatomical structure are fitted, positioning guide hole along template just can carry out locating and orienting accurately to each pedicle of vertebral arch, guarantee each piece of screw correct put people position and direction.Select suitable to put people's screw diameter and length in conjunction with three-dimensional measuring result again, really embody the principle of individuation that pedicle screw is inserted.
The present invention further discloses a kind of one-sided pedicle screw and enter to follow closely method prepared by auxiliary device, comprise following concrete steps:
1) foundation of vertebral body Three-dimension Reconstruction Model: CT scan is carried out to vertebral body, after CT Serial slices of image data are preserved in dicom format, import three-dimensional reconstruction software as: carry out reconstructing three-dimensional model in Mimics10.01, and derive the continuous curve surface model of IGES form, this form is a kind of general format of three-dimensional CAD file, can be directed at present multiple main flow Three-dimensional Design Software in the world.
Wherein carry out reconstructing three-dimensional model in Mimics10.01, its concrete reconstruction parameter is as follows:
(1) interpolation method (Interpolation method): because the method based on voxel (Gray value) is closer to the home position of real pixel and model, therefore in order to improve certainty of measurement, select the method;
(2) fairing (Smoothing): iterations (Iterations) selects 15 times, the fairing factor (Smooth factor) is set to 0.5;
(3) matrix compression (Matrix reduction): XY flat resolution selects 2 times of pixel values, and Z axis resolution selects 1 times of layer distance;
(4) matrix compression option (Prefer): select Accuracy algorithm, can make model accuracy keep higher;
Tri patch reduction (Triangle reduction): Advanced edge pattern is selected in reduction pattern (Reducing mode), acceptable error (Tolerance) selects 1/8 size of pixel value, coterminal angles degree (Edge angle) selects 15 °, and iterations (Iterations) selects 15 times.
2) locate and design screw positioning guide hole: by the above-mentioned 1st) model that obtains of step three-dimensional reconstruction imports Pro/E Wildfire4.0 software, process is optimized to model, comprise generation collector, finishing, relax, wherein 4X subdivision is selected in finishing, lax selection 15 iterationses, extract the tringle coal in the pedicle isthmus region, threedimensional model both sides after described optimization process, the tri patch that other are unnecessary removes, respectively left and right sides pedicle isthmus model is analyzed and measured, pedicle of vertebral arch front and rear edge contour line is adjusted to the direction overlapped as far as possible, and define the direction of now vertical screen for nail road axis direction, be parallel to screen and do a projection plane, by on model projection so far plane, and the contour line inside extraction, then on this projection plane, do this contour line maximum inscribed circle, determine the position (as shown in Figure 1) of its center of circle and circumference, this inscribed circle is stretched along nail road axis direction, obtain a cylindrical structural, be theoretical pedicle screw trajectory, with the cylinder pipeline that the best of pedicle screw nail road axis is benchmark generation hollow, the internal diameter of pipeline should be greater than the diameter of pedicle screw thread-cutting tool, and screw tap can be passed through smoothly, later lamina surface is the hollow circular cylinder pipeline that benchmark crops in vertebral body inside, and the pipeline of vertebral body outside is pedicle screw positioning guide hole, and the length of pilot hole is selected according to practical situation, preferably 1.5 ~ 2.5cm.
3) bottom of the first intermediate plate and the second intermediate plate is designed: extract the anatomic form curved surface of rear vertebral plate and spinous process and cutting is carried out to it, obtain desirable patch, next patch is thickeied 2-3mm process laterally, and by looking unfamiliar into entity, this entity is divided into two parts, a part is connected with the pilot hole of previous step, another part and the complementation of spinous process other side anatomical shape, the bottom of described first intermediate plate and the second intermediate plate and rear vertebral plate and spinous process root both sides anatomical shape complementary, seamless surface laminating can be realized.
4) the first intermediate plate and the second intermediate plate connecting portion and top is designed: the top of the first intermediate plate extends by bottom direction, and the second intermediate plate top and the first intermediate plate top extend at an angle, described angle [alpha] preferably 25 ° ~ 65 °.Respectively stretch out fan-shaped laminated structure in the middle of first intermediate plate and in the middle of the second intermediate plate, and laminated structure there is cavity, passes for transverse axis.
5) one-sided pedicle screw enters to follow closely making molding prepared by auxiliary device: adopt rapid shaping technique the pilot hole of above-mentioned design, the first intermediate plate and the second intermediate plate to be made as laser irradiates successively curing molding method, use giant to clean after molding, after removing backing material, put into ultrasonic washing unit cleaning.Pilot hole, the first intermediate plate and the second clip material can be medical photosensitive resin or Titanium.
6) one-sided pedicle screw enters to follow closely assembling prepared by auxiliary device: the sleeve pipe preparing transverse axis, torsionspring different size respectively, and with the 5th) step pilot hole, the first intermediate plate and the second intermediate plate prepared assemble and can obtain one-sided pedicle screw of the present invention and enter to follow closely auxiliary device.
One-sided pedicle screw prepared by the present invention enters to follow closely auxiliary device and has following beneficial effect:
1) put nail accuracy rate, screw can receptance and operation safety high;
2) shorten mean operative time, improve efficiency, reduce the risk exposing and infect;
3) enter to follow closely auxiliary device in operation easy to use, simple, only template closely need be fitted in corresponding anatomical structure, the accurate locating and orienting to art district can be completed;
4) postoperative need are clutched intermediate plate top and can be taken off easily into nail auxiliary device, tractive will be caused to injure to surrounding tissue.
5) enter to follow closely auxiliary device to cause because the phase para-position in operation between position chanP and adjacent vertebral bodies is dynamic and locate unsuccessfully, can change arbitrarily patient body position in operation, avoiding navigating affects its accuracy when patient body position changes;
6) bone structure is had to the patient of regression, deformity, hypertrophy, the inconvenient patient of point location of anatomic landmark, can use equally;
7) do not need the equipment such as the navigation system of other computers, do not take the corresponding special space of operating room; Sterilization is convenient, as long as Form board tape is entered operating room oxirane disinfection by operation consent.
Accompanying drawing explanation
The most nearside wheel profile of Fig. 1 pedicle isthmus model projection and maximum inscribed circle thereof;
Figure is seen above Fig. 2 lumbar vertebra three dimensions orthogonal basis directrix plane;
Figure is seen on Fig. 3 lumbar vertebra three dimensions orthogonal basis directrix plane left side, and A point is vertebral body frontal cortex outer rim, and B point is cortex outer rim after vertebral body, and C point is vertebral plate frontal cortex outer rim;
Figure is seen on Fig. 4 vertebral body sagittal diameter (CSD) and vertebral foramen sagittal diameter (SCSD) left side;
Fig. 5 interpedicular distance (DMBP) sees figure below;
The one-sided pedicle screw of Fig. 6 enters to follow closely auxiliary device overall schematic;
The one-sided pedicle screw of Fig. 7 enters to follow closely auxiliary device and splits rear schematic diagram.
Detailed description of the invention
Below in conjunction with accompanying drawing, the present invention will be further described, and following examples are the preferred embodiment of the present invention, is not limitation of the invention.
The one-sided pedicle screw of embodiment 1 enters to follow closely the structure of auxiliary device
As shown in Figure 6 and Figure 7, one-sided pedicle screw of the present invention enters to follow closely auxiliary device and comprises: pilot hole 1, sleeve pipe 2, first intermediate plate 3, second intermediate plate 4, torsionspring 5, transverse axis 6, wherein pilot hole 1 31 to be connected with bottom the first intermediate plate, first intermediate plate and the second middle part pressed from both sides have brace 32 and 42, brace has hole, and transverse axis 6 is successively through the hole of the hole of the first intermediate plate brace, torsionspring 5 and the second intermediate plate.Angle [alpha] between first intermediate plate and the second intermediate plate preferably 25 ° ~ 65 °.
Sleeve pipe 2 comprises casing head 21 and union body 22, and casing head is directly connected with union body, and wherein on casing head, the hole of 21 communicates with the internal gutter of union body 22 and diameters is equal.Described union body 22 inserts in pilot hole 1, and wherein the external diameter of union body 22 is identical with the internal diameter numerical value of pilot hole 1, and the internal diameter of union body 22 has different size, described union body internal diameter preferably 0.5 ~ 20mm.When changing the pedicle screw screw tap of Kirschner wire and different size in operation process, change the sleeve pipe mated with it accordingly, the external diameter of the pedicle screw screw tap of the internal diameter of described coupling fingerstall body and Kirschner wire and different size is equal.Its effect of described sleeve pipe assists the pedicle screw screw tap of Kirschner wire and different size through vertebral body more accurately.
The one-sided pedicle screw of embodiment 2 enters to follow closely the preparation of auxiliary device
One, materials and methods
1, material
Dry bone specimen 1 example of the in vitro lumbar vertebra of the adult normal of 10% formalin process of learning from else's experience, anatomical isolation also removes its attached soft tissue structure.Specimen is dissected teaching and research room by Beijing Union Medical College and is provided.
SIEMENS/Sensation64 layer CT machine, sweep parameter: thickness 2mm, layer distance 2mm, bulb voltage 120kV, electric current 225mAs, resolution 512*512pxl
Objet EDEN250 three-dimensional reconstruction printer, technical parameter: molding resolution X-axis: 600dpi:42u, Y-axis: 300dpi:84u, Z axis: 1600dpi:16u, (precision depends on body form to precision 0.1-0.2mm, parts purposes and stamp with the size), power supply 110-240VAC50/60Hz1.5KW, operating environment 18-25 DEG C, relative humidity 30%-70%
The medical transparent molding material of FullCure720:Objet company.
2, method
The present invention further discloses a kind of one-sided pedicle screw and enter to follow closely method prepared by auxiliary device, comprise following concrete steps:
1) foundation of vertebral body Three-dimension Reconstruction Model: CT scan is carried out to vertebral body, after CT Serial slices of image data are preserved in dicom format, import three-dimensional reconstruction software as: carry out reconstructing three-dimensional model in Mimics10.01, and derive the continuous curve surface model of IGES form, this form is a kind of general format of three-dimensional CAD file, can be directed at present multiple main flow Three-dimensional Design Software in the world.
Wherein carry out reconstructing three-dimensional model in Mimics10.01, its concrete reconstruction parameter is as follows:
(1) interpolation method (Interpolation method): because the method based on voxel (Gray value) is closer to the home position of real pixel and model, therefore in order to improve certainty of measurement, select the method;
(2) fairing (Smoothing): iterations (Iterations) selects 15 times, the fairing factor (Smooth factor) is set to 0.5;
(3) matrix compression (Matrix reduction): XY flat resolution selects 2 times of pixel values, and Z axis resolution selects 1 times of layer distance;
(4) matrix compression option (Prefer): select Accuracy algorithm, can make model accuracy keep higher;
(5) tri patch reduction (Triangle reduction): Advanced edge pattern is selected in reduction pattern (Reducing mode), acceptable error (Tolerance) selects 1/8 size of pixel value, coterminal angles degree (Edge angle) selects 15 °, and iterations (Iterations) selects 15 times.
According to above-mentioned parameter, three-dimensional reconstruction calculating is carried out to area-of-interest, the model calculated is carried out the double optimization process such as parcel again, final derivation form is the 3D model file of ASC II STL form, for further application engineering software Pro/E Wildfire4.0 carries out model optimization process, analysis, measures, determines that nail locus, road etc. provides original figure data.
Next, enter Pro/E Wildfire4.0 working environment, create the entity component template that a form is mmns_part_solid wherein, import the 3D model of the ASCIISTL form rebuild through Mimics, process is optimized to model, comprise spanning set, finishing, relax, wherein 4X subdivision is selected in finishing, lax selection 15 iterationses.According to the morphosis of vertebral body, take vertebral body as benchmark, when its upper and lower endplate surface contour line is overlapped as far as possible, normal to screen direction is z-axis direction, and in this side up definition sagittal benchmark midline plane, crown benchmark midline plane, make another according to above-mentioned two planes again and be defined as horizontal plane with datum plane all vertical both it, more than determine the three dimensions orthogonal basis directrix plane (as Fig. 2) of model for this reason.And according to seeing (Top View) above the contextual definition of face, face, seeing (Back View), left side sight (Left View) three visual directions below, convenient analysis to measure after this.
Model is carried out cutting along saggital midline datum plane, definition hatching curve, the leftmost point of this hatching and vertebral body frontal cortex outer rim is selected under Left View visual angle, be defined as A point, after defining vertebral body again on this section accordingly, cortex outer rim is B point, and vertebral plate frontal cortex outer rim is C point (as Fig. 3).
In like manner, model is carried out cutting along coronal midline datum plane, cortex outer rim inside the pedicle of vertebral arch of left and right can be found under Back View visual angle, be defined as D point respectively, E point.Then measure, wherein the line of A and B length of Projection Line Segment on transverse section is defined as vertebral body sagittal diameter (CSD), and the line Projection Line Segment length in the horizontal plane of B and C is defined as vertebral foramen sagittal diameter (SCSD) (as Fig. 4).Equally, the horizontal plane Projection Line Segment length of D and E line is defined as interpedicular distance (DMBP) (as Fig. 5), carries out respectively measuring and record.
Above-mentioned vertebral body sagittal diameter (CSD), vertebral foramen sagittal diameter (SCSD) and interpedicular distance (DMBP) are defined as follows: vertebral foramen sagittal diameter (spinal canal sagittal diameter, SCSD): the distance after vertebral body between cortex and vertebral plate frontal cortex outer rim;
Vertebral body sagittal diameter (centrum sagittal diameter, CSD): the distance before and after vertebral body between cortex outer rim;
Interpedicular distance (the distance between medical borders of pedicles, DMBP): the distance inside the pedicle of vertebral arch of both sides between cortex outer rim.
2) locate and design screw positioning guide hole: threedimensional model to be redefined and the tringle coal extracting pedicle isthmus region, both sides is region of interest, the tri patch that other are unnecessary removes, respectively left and right sides pedicle isthmus model is analyzed and measured, be described for side below, pedicle of vertebral arch front and rear edge contour line is adjusted to the direction overlapped as far as possible, and define the direction of now vertical screen for nail road axis direction, be parallel to screen and do a projection plane, by on model projection so far plane, and the contour line inside extraction, then on this projection plane, do this contour line maximum inscribed circle, determine the position (as Fig. 1) of its center of circle and circumference, this inscribed circle is stretched along nail road axis direction, obtain a cylindrical structural, be theoretical pedicle screw trajectory.
With the cylinder pipeline that the best of pedicle screw nail road axis is benchmark generation hollow, the internal diameter of pipeline should be greater than the diameter of pedicle screw thread-cutting tool, and screw tap can be passed through smoothly; Later lamina surface is the hollow circular cylinder pipeline that benchmark crops in vertebral body inside, and the pipeline of vertebral body outside is pedicle screw positioning guide hole, altogether two, left and right, and the length of pilot hole is selected according to practical situation, preferably 1.5 ~ 2.5cm.
3) bottom of the first intermediate plate and the second intermediate plate is designed: extract the anatomic form curved surface of rear vertebral plate and spinous process and cutting is carried out to it, obtain desirable patch, next patch is thickeied 2-3mm process laterally, and by looking unfamiliar into entity, this entity is divided into two parts, a part is connected with the pilot hole of previous step, another part and the complementation of spinous process other side anatomical shape, the bottom of described first intermediate plate and the second intermediate plate and rear vertebral plate and spinous process root both sides anatomical shape complementary, seamless surface laminating can be realized.
4) the first intermediate plate and the second intermediate plate connecting portion and top is designed: the top of the first intermediate plate extends by bottom direction, and the second intermediate plate top and the first intermediate plate top extend at an angle, described angle [alpha] preferably 25 ° ~ 65 °.Respectively stretch out fan-shaped laminated structure in the middle of first intermediate plate and in the middle of the second intermediate plate, and laminated structure there is cavity, passes for transverse axis.
5) one-sided pedicle screw enters to follow closely making molding prepared by auxiliary device: adopt laser to irradiate successively curing molding art and the pilot hole of above-mentioned design, the first intermediate plate and the second intermediate plate are made, use giant to clean after molding, after removing backing material, put into ultrasonic washing unit cleaning.
6) one-sided pedicle screw enters to follow closely assembling prepared by auxiliary device: the sleeve pipe preparing transverse axis, torsionspring different size respectively, and with the 5th) step pilot hole, the first intermediate plate and the second intermediate plate prepared assemble and can obtain one-sided pedicle screw of the present invention and enter to follow closely auxiliary device.
The one-sided pedicle screw that the present embodiment makes enters to follow closely auxiliary device, and wherein pilot hole, the first intermediate plate and the second clip material can be medical photosensitive resin or Titanium.
The preferred FullCure720 of its material (the medical photosensitive resin moulding material of Objet company), the advantage of this material is:
1) selection of material can the extensive application of subject range
2) model solidified completely takes off from pallet and can carry out carrying and touching, without the need to processing afterwards
3) easily remove gel-like support material, so there is no hard corner
4) model curved surface easily adsorbs paint, therefore can make outward appearance model true to nature
5) modeling material also can carry out processing, hole, chromium plating or be used as mould
6) easily change between different materials.
Two, result
According to said method, to design and the one-sided pedicle screw that completed enters to follow closely auxiliary device, as shown in Figure 6 and Figure 7.
The present invention enters to follow closely auxiliary device by above-mentioned preparation, in vertebral body specimen, implant pedicle screw, and experimental result shows, and pedicle screw is accurately implanted in vertebral body, does not pass the pedicle isthmus of vertebral body specimen.So prepared by method of the present invention enter to follow closely auxiliary device, pedicle of vertebral arch can be improved and implant the safety of vertebral body.
Claims (8)
1. one-sided pedicle screw enters to follow closely a preparation method for auxiliary device, specifically comprises the following steps:
(1) foundation of vertebral body Three-dimension Reconstruction Model: carry out CT scan to vertebral body, carries out reconstructing three-dimensional model by CT Serial slices of image data importing three-dimensional reconstruction software, and derives continuous curve surface model;
(2) locate and design screw positioning guide hole: by the above-mentioned 1st) model that obtains of step three-dimensional reconstruction imports Pro/E Wildfire 4.0 software, process is optimized to model, comprise generation collector, finishing, relax, wherein 4X subdivision is selected in finishing, lax selection 15 iterationses, extract the tringle coal in the pedicle isthmus region, threedimensional model both sides after described optimization process, the tri patch that other are unnecessary removes, respectively left and right sides pedicle isthmus model is analyzed and measured, pedicle of vertebral arch front and rear edge contour line is adjusted to the direction overlapped as far as possible, and define the direction of now vertical screen for nail road axis direction, be parallel to screen and do a projection plane, by on model projection so far plane, and the contour line inside extraction, then on this projection plane, do this contour line maximum inscribed circle, determine the position of its center of circle and circumference, this inscribed circle is stretched along nail road axis direction, obtain a cylindrical structural, be theoretical pedicle screw trajectory, with the cylinder pipeline that the best of pedicle screw nail road axis is benchmark generation hollow, the internal diameter of pipeline should be greater than the diameter of pedicle screw thread-cutting tool, and screw tap can be passed through smoothly, later lamina surface is the hollow circular cylinder pipeline that benchmark crops in vertebral body inside, and the pipeline of vertebral body outside is pedicle screw positioning guide hole,
(3) bottom of the first intermediate plate and the second intermediate plate is designed: extract the anatomic form curved surface of rear vertebral plate and spinous process and cutting is carried out to it, obtain desirable patch, next patch is thickeied 2-3mm process laterally, and by looking unfamiliar into entity, this entity is divided into two parts, a part is connected with the pilot hole of previous step, another part and the complementation of spinous process other side anatomical shape, the bottom of described first intermediate plate and the second intermediate plate and rear vertebral plate and spinous process root both sides anatomical shape complementary, seamless surface laminating can be realized;
(4) the first intermediate plate and the second intermediate plate connecting portion and top is designed: the top of the first intermediate plate extends by bottom direction, second intermediate plate top and the first intermediate plate top extend at an angle, described angle [alpha] is 25 ° ~ 65 °, fan-shaped laminated structure is respectively stretched out in the middle of first intermediate plate and in the middle of the second intermediate plate, and laminated structure has cavity, pass for transverse axis;
(5) one-sided pedicle screw enters to follow closely making molding prepared by auxiliary device: adopt rapid shaping technique the pilot hole of above-mentioned design, the first intermediate plate and the second intermediate plate to be made as laser irradiates successively curing molding method, use giant to clean after molding, after removing backing material, put into ultrasonic washing unit cleaning;
(6) one-sided pedicle screw enters to follow closely assembling prepared by auxiliary device: the sleeve pipe preparing transverse axis, torsionspring and different size respectively, and with the 5th) step pilot hole, the first intermediate plate and the second intermediate plate prepared assemble.
2. three-dimensional reconstruction software preparation method according to claim 1, is characterized in that, the 1st) described in step is Mimics10.01, and the concrete reconstruction parameter when three-dimensional reconstruction is as follows:
(1) interpolation method (Interpolation method): because the method based on voxel (Gray value) is closer to the home position of real pixel and model, therefore in order to improve certainty of measurement, select the method;
(2) fairing (Smoothing): iterations (Iterations) selects 15 times, the fairing factor (Smooth factor) is set to 0.5;
(3) matrix compression (Matrix reduction): XY flat resolution selects 2 times of pixel values, and Z axis resolution selects 1 times of layer distance;
(4) matrix compression option (Prefer): select Accuracy algorithm, can make model accuracy keep higher; Tri patch reduction (Triangle reduction): Advanced edge pattern is selected in reduction pattern (Reducing mode), acceptable error (Tolerance) selects 1/8 size of pixel value, coterminal angles degree (Edge angle) selects 15 °, and iterations (Iterations) selects 15 times.
3. be optimized process to model preparation method according to claim 1, is characterized in that, the 2nd) described in step, specifically comprise and generate collector, finishing, lax, wherein 4X subdivision is selected in finishing, lax selection 15 iterationses.
4. preparation method according to claim 1, is characterized in that, the 2nd) described in step, pilot hole length is 1.5 ~ 2.5cm.
5. one-sided pedicle screw prepared by the preparation method according to claim 1-4 any one enters to follow closely auxiliary device, it is characterized in that, described device comprises: pilot hole, sleeve pipe, the first intermediate plate, the second intermediate plate, transverse axis, torsionspring, wherein pilot hole is connected with bottom the first intermediate plate, first intermediate plate and the second middle part pressed from both sides have brace, brace has hole, and transverse axis is successively through the hole of the hole of the first intermediate plate brace, torsionspring and the second intermediate plate;
Described sleeve pipe comprises union body and casing head, and casing head is directly connected with union body, and the hole wherein on casing head communicates with the internal diameter of union body internal gutter; Described union body inserts in pilot hole, and wherein union body external diameter is identical with the diameter length of pilot hole internal diameter.
6. one-sided pedicle screw according to claim 5 enters to follow closely auxiliary device, it is characterized in that, the angle c between the first described intermediate plate and the second intermediate plate is 25 ° ~ 65 °.
7. one-sided pedicle screw according to claim 5 enters to follow closely auxiliary device, it is characterized in that, the internal diameter of described union body has different size, and described union body internal diameter is 0.5 ~ 20mm.
8. the one-sided pedicle screw in claim 6-7 described in any 1 enters to follow closely auxiliary device, it is characterized in that, the material that described one-sided pedicle screw enters to follow closely auxiliary device is medical photosensitive resin or Titanium.
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| CN103690278B (en) * | 2013-12-16 | 2016-03-02 | 深圳市第二人民医院 | The preparation method of the bionical vertebra system of the personalization based on 3D printing technique |
| CN105342689A (en) * | 2014-08-24 | 2016-02-24 | 方学伟 | Method for designing assistant positioning sleeve of personalized navigation template |
| CN104224306B (en) * | 2014-09-30 | 2017-08-01 | 华蓥市人民医院 | The threedimensional model of the optimal access point of pedicle screw is inserted for finding |
| CN104622535B (en) * | 2015-02-28 | 2017-01-04 | 武晓炜 | Spinal column surface of bone coincide location drilling guide apparatus and preparation method thereof |
| CN106137305B (en) * | 2015-10-30 | 2018-02-13 | 自贡市第四人民医院 | A kind of Thoracolumbar disk deformity is through way of escape individuation osteotomy navigation template preparation method |
| WO2017186799A1 (en) | 2016-04-28 | 2017-11-02 | Koninklijke Philips N.V. | Determining an optimal placement of a pedicle screw |
| CN107007344B (en) * | 2017-05-31 | 2020-09-01 | 上海光韵达数字医疗科技有限公司 | Percutaneous nail-placing guide plate |
| CN112022344A (en) * | 2020-07-22 | 2020-12-04 | 自贡市第四人民医院(自贡市急救中心) | Determination and verification method of orthopedic surgery nail placing channel based on three-dimensional modeling |
| CN112315581B (en) * | 2020-09-29 | 2022-05-06 | 上海霖晏医疗科技有限公司 | Method and device for determining pedicle screw feeding point |
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| CN2407724Y (en) * | 1999-12-31 | 2000-11-29 | 邢台矿业(集团)有限责任公司总医院 | Stereo positioing needle for pedicle of vertebral arch |
| CA2556102C (en) * | 2004-02-20 | 2012-07-17 | Hector O. Pacheco | Method for improving pedicle screw placement in spinal surgery |
| CN201275138Y (en) * | 2008-10-30 | 2009-07-22 | 于杰 | Three-dimensional adjustable screw locater for vertebral pedicle |
| CN201404283Y (en) * | 2009-04-13 | 2010-02-17 | 郑明辉 | Locating device of vertebral pedicle nail |
| US20130053896A1 (en) * | 2011-08-29 | 2013-02-28 | Jean-Marc VOYADZIS | Adaptable systems, methods, and devices for percutaneously implanting a spinal screw |
| CN203252720U (en) * | 2013-03-06 | 2013-10-30 | 吴志宏 | Nail entrance navigation device |
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