CN106691562B - Personalized pedicle of vertebral arch with Quick-change drill bush puts nail bit mould and preparation method thereof - Google Patents

Personalized pedicle of vertebral arch with Quick-change drill bush puts nail bit mould and preparation method thereof Download PDF

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Publication number
CN106691562B
CN106691562B CN201611012148.2A CN201611012148A CN106691562B CN 106691562 B CN106691562 B CN 106691562B CN 201611012148 A CN201611012148 A CN 201611012148A CN 106691562 B CN106691562 B CN 106691562B
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China
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pedicle
vertebral arch
nail
targeted vertebra
drill bushing
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CN106691562A (en
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胡良斌
李必文
秦元帅
邓骞
李军
周炬
谭文甫
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University of South China
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University of South China
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7074Tools specially adapted for spinal fixation operations other than for bone removal or filler handling
    • A61B17/7076Tools specially adapted for spinal fixation operations other than for bone removal or filler handling for driving, positioning or assembling spinal clamps or bone anchors specially adapted for spinal fixation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/90Guides therefor

Abstract

Personalized pedicle of vertebral arch with Quick-change drill bush puts nail bit mould and preparation method thereof, and the personalized pedicle of vertebral arch, which puts nail bit mould, includes body and drill bushing;Body lower end is provided with bone binding face and bottom surface, and upper end, which is provided with, puts nail plane, and front and rear sides wall is cheated provided with finger pressure, is put nail channel provided with two in body, is put nail channel one end and penetrate to nail plane is put, the other end is penetrated to bottom surface;Drill bushing is arranged on and put in nail channel, and the two forms interference fits.The method have the advantages that the physical dimension and bone binding face of body are designed all in accordance with the form of targeted vertebra, size and with the position relationship of adjacent vertebrae, there is obvious personalized customization feature.The thread Pilot hole of pedicle screw is drilled out by drill bushing, replant into pedicle screw, both can ensure not wearing out pedicle of vertebral arch cortex, ensure that screw has larger diameter in the range of the permission of vertebral arch radical space, so as to have firm three-dimensional fixed effect after guarantee implantation to large extent, replicating again for vertebral joint biomechanics characteristic is realized.

Description

Personalized pedicle of vertebral arch with Quick-change drill bush puts nail bit mould and preparation method thereof
Technical field
The present invention relates to technical field of medical instruments, more particularly to a kind of personalized pedicle of vertebral arch with Quick-change drill bush puts nail bit Mould and preparation method thereof.
Background technology
Fixed surgical indication closes suitable for the tumor of spinal cord of backbone, retrogression pathological changes, rheumatoid in pedicle screw Section inflammation and infectious diseases, especially resetted, in corrective procedure in treatment vertebral slippage, pedicle of Vertebral Arch Fixation is the most reliable Fixed form.Because pedicle screw can play three-dimensional fixation, have mechanical strength is high, fixed and Fusion levels are few, The advantages that deformity of spine rectification effect is good, its clinical practice are more and more extensive.
Biomechanics experiment proves, only inserts screw along the dissection major axis of pedicle of vertebral arch and reaches depth desired, can just obtain Obtain preferable clinical effectiveness.Spinal vertebral surrounding anatomical structures are complicated, and front is adjacent with big blood vessel, internal organs, are on the inside of pedicle of vertebral arch Canalis spinalis, lower section are nerve root, and can the success or failure key of the pedicle screw internal fixation operation of pedicle is accurately by certainly Attack screw pedicle and be screwed into centrum, do not wear out pedicle of vertebral arch cortex.Screw is put by mistake can cause spinal cord, nerve damage, internal organs, blood Pipe damages, or even threat to life.Moreover, upward from lumbar vertebrae, thoracic vertebrae, the pedicle diameter of cervical vertebra are gradually reduced, and cause operation difficult Degree increase, operation risk improve.And personal vertebral arch root morphology has larger variability, screw is caused to put nail fault rate liter It is high.Cause the clinical report of the complication such as neurotrosis, pedicle screw loosening because pedicle screw implantation site is improper simultaneously It is not rare.Therefore, related medical technology and engineering technology how are relied on, helps doctor to complete operation pathway planning, accurately draw The implantation of implants is led, is always the problem that domestic and international basis is extremely paid close attention to clinical research.
At present, determine that pedicle screw enters to follow closely angle and the main method of entry point and had:Anatomic landmark point method, vertebral lamina fenestration Method, X-ray examination method, computer navigation method, navigation template method etc..The entry point of anatomic points notation, enter to follow closely angle and mainly pass through The experience of patient judges that accurate say isByThe opposed nail channel of feel and pedicle probe of patient is felt to ensure vertebral arch The accurate of root screw is inserted, and requires higher to the clinical experience of doctor, and precision is difficult to ensure that.Vertebral lamina fenestration is inevitably Increase operating time and intraoperative blood loss.The operating time of X-ray examination auxiliary law is longer, the x-ray that patient and medical personnel are subject to Amount of radiation is larger.Gradually applied during computer navigation method is fixed in pedicle screw in recent years, it is real-time using patient Pedicle of vertebral arch image information carrys out guided operation, reduces operation risk, reduces the time of doctor and patient contact ray, has larger Advantage, but navigation equipment is expensive, complex operation, and clinic popularization still suffers from difficulty.Navigation template method is based on 3D printing skill Art produces navigation template, has and operation quick response and efficiency-cost ratio advantage, existing individuation navigation template are primarily present The problem of three aspects:First, template thickness is relatively thin, rigidity is poor, be not easy to hold in art, during drilling template be also easy to produce deformation and Rock;Second, without the conduit of the navigation template of sleeve is easy to wear and fusing, and its sleeve of the navigation template with sleeve and template Between for gap coordinate and have relative rotation, this can influence orientation accuracy and using effect;Third, pedicle of vertebral arch puts the rule of nail channel Draw and lack effective theoretical and means support, its optimization method, operating efficiency and planning effect have much room for improvement.
Therefore, need badly design it is a set of can accurately, efficiently plan pedicle screw entry point, insert angle, diameter with The method of length, and the result of calculation based on this method prepare applied to operation " nail bit mould is put in personalization ", in order to Pedicle screw is inserted in pedicle screw internal fixation operation safety and precise, realizes replicating again for vertebra biomechanics characteristic, Improve patients ' life quality.
The content of the invention
The purpose of the present invention is to overcome the shortcomings of existing method and technology, and provides a kind of personalized vertebra with Quick-change drill bush Nut puts nail bit mould and preparation method thereof, puts nail bit mould by the personalized pedicle of vertebral arch with Quick-change drill bush, patient is in pedicle of vertebral arch It can fast and accurately implement into nail in ligamentopexis, realize that complicated operation safe, key operation simplification, apparatus cost are cheap Change.
The technical scheme is that:Personalized pedicle of vertebral arch with Quick-change drill bush puts nail bit mould, including body and drill bushing;This Body lower end is provided with bone binding face and bottom surface, and upper end, which is provided with, puts nail plane, and body front and rear sides wall is cheated provided with finger pressure, is set in body There are two to put nail channel, put nail channel one end and penetrate to nail plane is put, the other end is penetrated to bottom surface;Drill bushing is arranged on and puts nail channel Interior, the two forms interference fits.
Further technical scheme is the present invention:Drill bushing is shorter in length than the length for putting nail channel, is put when drill bushing is arranged on In nail channel, put one section of nail channel and contacted with drill bushing, another section does not contact with drill bushing, puts one section that nail channel does not contact with drill bushing For chip removal chamber, chip removal chamber is communicated to bottom surface.
Further technical scheme is the present invention:Bone binding face can be with targeted vertebra vertebral plate, transverse process rear portion and spinous process root The profile of portion's dorsal part, which attaches, to coincide;When bone binding face and targeted vertebra, which attach, coincide, the central axis and target of nail channel are put The axis of the maximum inscribed Elliptic Cylinder of pedicles of vertebrae overlaps;The adjacent vertebrae is below targeted vertebra and and target One piece of vertebra of vertebrae adjacent.
Technical scheme of the invention further is:Wall avoids with body bottom surface intersection provided with transverse process at left and right sides of body Chamfering;The position that bone binding face corresponds to targeted vertebra spinous process top is provided with spinous process avoidance groove;Bone binding face corresponds to adjacent vertebrae The position of processus articular superior is provided with processus articular superior and avoids groove.
The preparation method that the described personalized pedicle of vertebral arch with Quick-change drill bush puts nail bit mould is as follows:
S01, obtain targeted vertebra medical image:Transfer spiral CT examination data or nuclear magnetic resonance before patient's diagnosis Data are checked, select the data of operative region targeted vertebra, save as the recognizable form of medical image software;
S02, reconstruct the threedimensional model and central point point set of targeted vertebra:The medical image of targeted vertebra is imported into doctor Image software Mimics is learned, rebuilds the threedimensional model of targeted vertebra, then obtain the central point point set of targeted vertebra, central point point set It is made up of the discrete point that spacing is a, threedimensional model and central point point set is saved as into STL forms, IGS forms respectively;
In this step, a interval is 0.01mm~0.1mm;
S03, create and to be modified once enter staple line:Threedimensional model and central point point set data file are imported into reverse-engineering In software I mageware, the central point point set in the pedicle of vertebral arch length range of side is then chosen, creates nurbs curve, M equidistant point is taken on nurbs curve, and makes tangent line of the nurbs curve this m positions, this m point is crossed and is respectively created Perpendicular to a m normal sections of each tangent line, the n individual one including being extracted in a m normal sections comprising pedicle isthmus Secondary normal section, nurbs curve form n intersection point with this n normal sections, obtain the least-squares line of this n intersection point, i.e., Once to enter staple line;
In this step, n >=7, m >=n;
S04, create it is secondary enter staple line:By n intersection point in S03 steps, it is respectively created perpendicular to the n for once entering staple line Individual secondary normal section;Extract the outer contour of pedicle of vertebral arch respectively on n secondary normal sections, then created in each outer contour Maximum inscribed circle is built out, the center of circle of each maximum inscribed circle is sequentially connected, a space broken line is formed, obtains the space broken line Least-squares line, as it is secondary enter staple line;
In this step, it is secondary enter staple line be that final pedicle screw enters to follow closely route;
S05, it is determined that along it is secondary enter staple line direction the maximum inscribed Elliptic Cylinder of pedicle of vertebral arch cross section:Pass through S03 steps In n intersection point, be respectively created perpendicular to it is secondary enter staple line n three times normal sections, carried respectively on normal section three times at this n Take the outer contour of pedicle of vertebral arch, then by the n outer contour extracted along it is secondary enter staple line vector direction, near mesh Mark vertebra centrum is projected on normal section three times, is internally formed a closed interval after projection superposition, is made the enclosed area In maximum inner ellipse, the maximum inner ellipse be along it is secondary enter staple line direction the maximum inscribed Elliptic Cylinder of pedicle of vertebral arch Cross section;
S06, determine pedicle screw and put the interval of nail channel diameter:Using the center of the maximum inner ellipse as Center, r are semi-minor axis length, and h is semimajor axis length, make concentration ellipse in maximum inner ellipse, and ensure concentration ellipse Short axle is overlapping with the short axle of maximum inner ellipse, by the minor axis length of the concentration ellipse and pharmaceuticals industry standard YY0018-2002 The external thread diameter size of the metal bone screw of defined is compared and downward rounding, determines that pedicle screw external screw thread is straight Footpath d1, the diameter of thread d2 taken corresponding to d1 is looked into, the basic size using d2 as drill bushing internal diameter, using d2+2 δ as drill bushing external diameter Basic size, then according to drill bushing and put nail channel matching relationship determine put nail channel diameter;
In this step, r=b-x-y;h=c-x-y;B is the semi-minor axis length of maximum inner ellipse, and c is maximum inner ellipse Semimajor axis length, x be targeted vertebra pedicle of vertebral arch thickness of cortex of bone statistical value, y be body drilling offset distance, y value area Between be 0.3~0.5mm;δ is the wall thickness of drill bushing, and δ interval is 1.5~1.75mm;
S07, S03~S06 is repeated in, obtains the opposite side pedicle of vertebral arch relative with " side pedicle of vertebral arch " in S03 steps It is secondary enter staple line, pedicle screw and the interval for putting nail channel diameter;
S08, establish this body three-dimensional models:The threedimensional model file of targeted vertebra and its adjacent vertebrae is imported into PRO/E In;According to the form of targeted vertebra, size and position relationship with adjacent vertebrae, body initial configuration model is established, further according to It is secondary enter staple line linear equation and selection put nail channel diameter, established on body initial configuration model and put nail channel, then The body initial configuration model for targeted vertebra and band being put in Mimics nail channel is matched, using Boolean calculation in body Lower end generates the reverse curved surface of targeted vertebra locating surface, as the bone binding face of body, so as to realize building for this body three-dimensional models It is vertical;
S09, manufacture personalized pedicle of vertebral arch and put nail bit mould:Designed body three-dimensional models are produced with 3D printing technique Come, and designed drill bushing is also manufactured, while produce the 3D printing model of targeted vertebra, be easy to the preoperative experiment of doctor With assessment.
It is preferred that in step S08, when establishing body initial configuration model, the convenience of clamping is considered, in body front and rear sides Finger pressure is set to cheat on wall, holding position when nail bit die worker makees is put in finger pressure hole as personalized pedicle of vertebral arch.
It is preferred that in step S08, when establishing body initial configuration model, carry out empty avoiding at three and handle, at described three at empty avoiding Reason is included in wall at left and right sides of body and sets transverse process to avoid chamfering with bottom surface intersection, to avoid the transverse process position pair of adjacent vertebrae The interference of body installation positioning;The position that bone binding face corresponds to targeted vertebra spinous process top sets spinous process to avoid groove, to avoid The interference effect that spinous process lateral protrusions position to bone binding face curved surface;Bone binding face corresponds to close on adjacent vertebrae processus articular superior position Section is prominent to avoid groove, bone binding face curved surface is positioned with to avoid the relative motion change in location between targeted vertebra and adjacent vertebrae Interference effect.
The present invention has the following advantages that compared with prior art:
1st, using the preparation method in the present invention, it can produce to attach with targeted vertebra positioning curved surface and coincide good and have The personalized pedicle of vertebral arch that high accuracy puts nail channel puts nail bit mould.Patient can accurately and rapidly implement pedicle of vertebral arch screw by this drill jig Internal fixation is followed closely, both improves procedure efficiency, has ensured the accuracy and security of operation again.
2nd, the bone binding face of the physical dimension of body and body lower end all in accordance with the form of targeted vertebra, size and with it is adjacent The position relationship of vertebra is designed, and has obvious personalized customization feature.Body interior put nail channel space angle and Diameter is that the respective algorithms in preparation method are calculated.Can be in targeted vertebra pedicle of vertebral arch by the drill bushing of body interior The thread Pilot hole of pedicle screw is inside drilled out, the pedicle screw being implanted into by thread Pilot hole, can both ensure not wear out pedicle of vertebral arch Cortex, ensure that screw has larger diameter in the range of the permission of vertebral arch radical space, so as to ensure to plant to large extent There is excellent biomechanics characteristic and firm three-dimensional fixed effect after entering, realize the multiple again of vertebral joint biomechanics characteristic System.
3rd, finger pressure hole is provided with the wall of body front and rear sides, meets ergonomics, can easily enter when drill jig works Row is held and pressure, not only can effectively reduce the vibration of drill jig, moreover it is possible to effectively prevent between drill jig and targeted vertebra, patient Skidding occurs between finger and drill jig.
4th, the put drill bushing provided with metal material, the drill bushing in nail channel of body are shorter in length than the length for putting nail channel, when Drill bushing be arranged on put in nail channel, put one section of nail channel and contacted with drill bushing, another section does not contact with drill bushing, put nail channel not with brill One section of set contact is chip removal chamber, and chip removal chamber can accommodate the bone bits drilled out, bit cutting blade tip when effectively can avoid spudding in again Scratch of the angle to drill bushing endoporus.During drill bushing uses prepared by carbon quenched and tempered steel (45 steel or medium carbon alloy steel 40Cr), it had both been had good Good comprehensive mechanical performance and wearability, it is easy to use definite value reamer to carry out Precision Machining to its small size internal diameter again.Performing the operation Middle drill bushing not only drills out screw thread bottom outlet in pedicle of vertebral arch for drill bit and provides accurate guide effect, and can keep good size Stability, so as to ensure to be formed between drill bit and drill bushing it is high-precision coordinate (the ratio between chip clearance and bit diameter for 0.5~ 1).Metal drill bushing can quick dispatch, reusable, both improve procedure efficiency, reduce apparatus cost again.
5th, body, which is provided with three, optimizes structure:Wall is provided with transverse process with bottom surface intersection and avoids chamfering at left and right sides of body, It can avoid the transverse process position of adjacent vertebrae that the interference of positioning is installed to body;Bone binding face corresponds to the portion on targeted vertebra spinous process top Position is provided with spinous process and avoids groove, the interference effect that spinous process lateral protrusions can be avoided to position bone binding face curved surface;Bone binding face pair Answer the position of adjacent vertebrae processus articular superior to be provided with processus articular superior and avoid groove, can avoid relative between targeted vertebra and adjacent vertebrae Interference effect of the movement position change to the positioning of bone binding face curved surface.
Below in conjunction with figure, the invention will be further described with embodiment.
Brief description of the drawings
Fig. 1 is the front view that the personalized pedicle of vertebral arch with Quick-change drill bush puts nail bit mould;
Fig. 2 is Fig. 1 top view;
Fig. 3 is Fig. 1 left view;
Fig. 4 is the dimensional structure diagram that the personalized pedicle of vertebral arch with Quick-change drill bush puts nail bit mould;
Fig. 5 is the use state diagram that the personalized pedicle of vertebral arch with Quick-change drill bush puts nail bit mould;
Fig. 6 is the structural representation of body;
Fig. 7 is targeted vertebra and the position relationship schematic diagram of adjacent vertebrae;
Fig. 8 is matching status schematic diagram of the threedimensional model with its central point point set of targeted vertebra;
Fig. 9 is the generation view for once entering staple line to be modified;
Figure 10 be it is secondary enter staple line generation view;
Figure 11 is the generation view of normal section three times;
Figure 12 enters nail channel for safety and generates view.
Explanation:For the structure of more intuitive show ontology, Fig. 3 uses broken section putting at nail channel.
Part marginal data:Body 1;Bone binding face 11;Put nail plane 12;Put nail channel 13;Finger pressure hole 14;Bottom surface 15; Transverse process avoids chamfering 16;Spinous process avoids groove 17;Processus articular superior avoids groove 18;Drill bushing 2;Ring-shaped step 21;Targeted vertebra 31; Spinous process 311;Central point point set 32;Nurbs curve 33;Once enter staple line 34;Normal section 35;Secondary normal section 36;It is maximum Inscribed circle 37;Space broken line 38;It is secondary enter staple line 39;Normal section 40 three times;Maximum inner ellipse 41;Concentration ellipse 42;It is adjacent Vertebra 9;Transverse process 91;Processus articular superior 92.
Embodiment
Embodiment 1:
As shown in figs. 1 to 6, the personalized pedicle of vertebral arch with Quick-change drill bush puts nail bit mould, including body 1 and drill bushing 2.
The lower end of body 1 is provided with bone binding face 11 and bottom surface 15, and upper end, which is provided with, puts nail plane 12.Body puts nail provided with two Passage 13, put the one end of nail channel 13 and penetrate to nail plane 12 is put, the other end is penetrated to bottom surface 15.Bone binding face 11 and targeted vertebra The profile of 31 vertebral plates, transverse process rear portion and spinous process root dorsal part, which attaches, to coincide.It is coincide when bone binding face 11 and targeted vertebra 31 attach When, the central axis 132 for putting nail channel 13 overlaps with the axis of the maximum inscribed Elliptic Cylinder of the pedicle of vertebral arch of targeted vertebra 31.
Drill bushing 2 is arranged on and put in nail channel 13, and the two forms interference fits, that is, forms gap or interference fit (may be selected H8/js7 or H8/k7), but gap value or the equal very little of the magnitude of interference, it is easily installed and dismantles again while orientation accuracy is ensured.
It is preferred that the edge of the front and rear sides wall of body 1 is provided with finger pressure hole 14.
Step surface 131 is provided with it is preferred that it is shoulder hole to put nail channel 13, in it, the outer wall of drill bushing 2 is provided with ring-shaped step 21; Put when drill bushing 2 is arranged in nail channel 13, drill bushing 2 is by ring-shaped step 21 thereon and puts the step surface 131 in nail channel 13 It is in contact and is axially located.
It is preferred that as shown in Fig. 2,7, the left and right sides wall of body 1 is provided with transverse process with the intersection of bottom surface 15 and avoids chamfering 16, can keep away The position of transverse process 91 for exempting from adjacent vertebrae 9 is installed by the interference of positioning to body;On the corresponding spinous process 311 of targeted vertebra 31 of bone binding face 11 The position in portion is provided with spinous process and avoids groove 17, the interference effect that spinous process lateral protrusions can be avoided to position the curved surface of bone binding face 11; The position of the corresponding processus articular superior 92 of adjacent vertebrae 9 of bone binding face 11 is provided with processus articular superior and avoids groove 18, can avoid targeted vertebra The interference effect that relative motion change in location between 31 and adjacent vertebrae 9 positions to the curved surface of bone binding face 11.
The described preparation method that nail bit mould is put with Quick-change drill bush personalization pedicle of vertebral arch is as follows:
S01, obtain targeted vertebra medical image:Transfer spiral CT examination data or nuclear magnetic resonance before patient's diagnosis Data are checked, select the data of operative region targeted vertebra, medical image software Mimics is saved as and can recognize that form.
S02, reconstruct the threedimensional model and central point point set of targeted vertebra:The medical image of targeted vertebra 31 is imported Medical image software Mimics, filtering, noise reduction means is taken to carry out the pre-treatment of two dimensional image, further according to the wheel of targeted vertebra 31 Exterior feature carries out threshold value separation, establishes mask, rebuilds the threedimensional model of targeted vertebra 31, then pass through " the center line plan built in Mimics The central point point set 32 of conjunction " function generation targeted vertebra 31, central point point set 32 are made up of the discrete point that spacing is 0.05mm, will The threedimensional model and central point point set 32 of targeted vertebra 31 save as STL forms, IGS forms respectively.
In this step, a interval is 0.01mm~0.1mm;The central point point set 32 is the barycenter of targeted vertebra 31 The point set of composition.
S03, create and to be modified once enter staple line:The threedimensional model of targeted vertebra 31 and central point point set 32 are imported inverse Into engineering software Imageware (as shown in Figure 8), the central point point set 32 in the pedicle of vertebral arch length range of side is then chosen, Nurbs curve 33 is created, 21 equidistant points are taken on nurbs curve, and make nurbs curve 33 in this 21 positions 21 normal sections 35 perpendicular to each tangent line are respectively created in tangent line, excessively this 21 points, are extracted in 21 normal sections Normal section (as shown in Figure 9) of 7 gone out including pedicle isthmus;According to nurbs curve and 7 normal sections The D coordinates value of 7 intersection points, the M files based on Matlab obtain its least-squares line equation, and are painted in Imageware The least-squares line is made, the least-squares line is once to enter staple line 34 (as shown in Figure 9).
In this step, the nurbs curve is non-homogeneous B spline curve, is the central point point with pedicle area Integrate as node, the continuous smooth curve of created in Imageware.The isthmus is one section of most narrow area of pedicle of vertebral arch Domain, the 5%~15% of pedicle of vertebral arch total length is accounted for, on the premise of central point spacing densification, be easy to obtain in a m normal sections.
S04, create it is secondary enter staple line:Created by 7 intersection points being formed in S03 steps perpendicular to once entering staple line 34 7 secondary normal sections 36, the outer contour of pedicle of vertebral arch is extracted respectively on 7 secondary normal sections 36, then in each foreign steamer Maximum inscribed circle 37 is created that in profile, the center of circle of 7 maximum inscribed circles is sequentially connected, forms a space broken line 38 (such as Shown in Figure 10);M files based on Matlab obtain the least-squares line equation of space broken line 38;Drawn in Imageware Go out the least-squares line of space broken line 38, the least-squares line be it is secondary enter staple line 39 (as shown in Figure 10).
In this step, it is secondary enter staple line 39 be that final pedicle screw enters to follow closely route.
S05, it is determined that along it is secondary enter staple line direction the maximum inscribed Elliptic Cylinder of pedicle of vertebral arch cross section:Pass through S03 steps In 7 intersection points, be respectively created perpendicular to it is secondary enter 7 of staple line 39 normal section 40 three times, at 7 three times on normal section 40 point Indescribably take the outer contour (as shown in figure 11) of pedicle of vertebral arch, then by extract 7 outer contours along it is secondary enter staple line vector Direction, projected on the normal section three times 40 near the centrum of targeted vertebra 31, one is internally formed after 7 projection superpositions Closed interval (according to medical statistics, this closed interval forms a similar elliptical shape), makes in the closed interval most Big inner ellipse 41 (as shown in figure 12), the minor axis length of maximum inner ellipse 41 is 8.2mm, long axis length 10.2mm, is somebody's turn to do Maximum inner ellipse 41 be along it is secondary enter staple line direction the maximum inscribed Elliptic Cylinder of pedicle of vertebral arch cross section.
S06, determine pedicle screw and put the interval of nail channel diameter:Using the center of maximum inner ellipse 41 in The heart, 2.1mm are semi-minor axis length, and 3.1mm is semimajor axis length, makees (such as Figure 12 of concentration ellipse 42 in maximum inner ellipse 41 It is shown), and ensure that the short axle of concentration ellipse 42 is overlapping with the short axle of maximum inner ellipse 41, the short axle of the concentration ellipse 42 is grown Degree and pharmaceuticals industry standard YY0018-2002《Synosteosis implant metal bone screw》The outer spiral shell of the metal bone screw of defined Line diameter dimension is compared, and downward rounding, is inquired about and is determined the model HA4.0 of pedicle screw, its external thread diameter D1 is 4.0mm, and diameter of thread d2 is 2.9mm, so that it is determined that the basic size of drill bushing internal diameter and the drill bit for drilling out thread Pilot hole are straight Footpath is 2.9mm;Using d2+2 δ (the wall thickness δ of drill bushing is 1.5mm) as the basic size of drill bushing external diameter, so that it is determined that it is logical to put nail The diameter in road and the basic size of drill bushing external diameter are 5.9mm.
In this step, the statistical value x of the section pedicle of vertebral arch thickness of cortex of bone is 1.7mm, and the drilling offset distance y of body is 0.3mm, the semi-minor axis length b of maximum inner ellipse 41 is 4.1mm, and the semimajor axis length c of maximum inner ellipse 41 is 5.1mm, The semi-minor axis length of concentration ellipse 42 is r, and the semimajor axis length of concentration ellipse 42 is h, is calculated according to formula r=b- (x+y) The semi-minor axis length r of concentration ellipse 42 is 2.1mm, and the semi-major axis that concentration ellipse 42 is calculated according to formula h=c- (x+y) is grown Degree h is 3.1mm.
S07, S03~S06 is repeated in, obtains the opposite side pedicle of vertebral arch relative with " side pedicle of vertebral arch " in S03 steps It is secondary enter staple line, pedicle screw and the interval for putting nail channel diameter.
S08, establish the threedimensional model of body:By targeted vertebra 31 and its threedimensional model file (the STL lattice of adjacent vertebrae 9 Formula) it imported into PRO/E;According to the form of targeted vertebra 31, size and position relationship with adjacent vertebrae 9, at the beginning of establishing body Beginning structural model, further according to both sides pedicle of vertebral arch it is secondary enter staple line linear equation and selection put nail channel diameter, at the beginning of body Established on beginning structural model and put nail channel 13, the body for then targeted vertebra 31 and band being put in Mimics nail channel 13 is initial Structural model is matched, and is generated the reverse curved surface of the locating surface of targeted vertebra 31 in the lower end of body 1 using Boolean calculation, is used as this The bone binding face 11 of body 1, so as to realize the foundation of this body three-dimensional models.
S09, manufacture the personalized pedicle of vertebral arch with Quick-change drill bush and put nail bit mould:Personalized pedicle of vertebral arch with Quick-change drill bush is put The threedimensional model file (STL forms) of nail bit mould is imported in 3D printing software Cura, carries out 3D printing manufacture, and will be designed Drill bushing also manufactures, while produces the 3D printing model of targeted vertebra, is easy to the preoperative experiment of doctor and assesses.
The planning for putting nail channel in preparation method of the present invention to body employs the cad technique of uniqueness, is effectively lifted The quality and efficiency of planning.The key that nail channel is put in planning is that Elliptic Cylinder is inscribed in the maximum for finding pedicle of vertebral arch, according to this really Determine pedicle screw to enter to follow closely direction and screw diameter.
This preparation method is primarily based on the central point point set data in the pedicle of vertebral arch length range automatically generated in Mimics, The pedicle of vertebral arch center line of nurbs curve form is created in Imageware, pedicle of vertebral arch is maximum to be inscribed cylindroid in this, as seeking The primary data of body axis, avoiding problems the blindness and arbitrariness to the maximum inscribed Elliptic Cylinder initial plan of pedicle of vertebral arch.
If next consider only maximum inscribed ellipse to set pedicle of vertebral arch to the normal of nurbs curve normal section with isthmus The axis vector of cylinder, then do not have ergodic, therefore choose n characteristic point of nurbs curve in pedicle of vertebral arch length range Solve and draw out least-squares line, as staple line is once entered, complete to entering to follow closely direction that is, maximum inscribed Elliptic Cylinder axle The first time amendment of line vector.
It should be noted that as important mathematical modeling, least square method because theoretical ripe, algorithm is simple and easy to do and It is used widely in survey engineering, standard GB/T/T 1958-2004《Product geometric sense technical specification(GPS)Shape and position Put tolerance detection regulation》Also illustrate, on the premise of functional requirement is met, it is allowed to replace minimal condition to comment using approximation method Determine form error, including axis straightness error.
Next, it is contemplated that once enter the initial data of staple line from n not parallel section in pedicle of vertebral arch length range The central point in face (normal section), i.e. center of mass point, although the initial plan for the maximum inscribed Elliptic Cylinder of pedicle of vertebral arch provides It is convenient, but if using its as finally enter to follow closely direction, then due to the complexity of pedicle of vertebral arch anatomic morphological occur it is larger Vector error, the center of circle of the maximum inscribed circle in n secondary normal sections along once enter the projective distribution of staple line vector one compared with In big scope, this larger dislocation causes the diameter for the maximum inscribed Elliptic Cylinder of pedicle of vertebral arch made less than normal, therefore correctly may be used Capable way is the circle center line connecting by asking for maximum inscribed circle, further asks for the least-squares line of the line as secondary Enter staple line, second of amendment to entering to follow closely direction that is, maximum inscribed Elliptic Cylinder axis vector is completed, in the vector direction energy Obtain the maximum inscribed Elliptic Cylinder diameter of bigger pedicle of vertebral arch.
By virtual experimental, find such as using it is secondary enter staple line isthmus normal section maximum inscribed circle as pedicle of vertebral arch most Elliptic Cylinder diameter inscribed greatly, can produce slight broken wall phenomenon, therefore the pedicle of vertebral arch outline that will first be extracted three times on normal section Line along it is secondary enter staple line vector direction project and be superimposed, found by Practice in Computer Graphics, n outer contour projection superposition Afterwards, internal closed area is similar to an ellipse, therefore, can ask for the maximum inner ellipse in closed interval, as along two It is secondary enter staple line direction pedicle of vertebral arch maximum inscribed Elliptic Cylinder cross section, the Virtual Test Validation security of this method.
Then make concentration ellipse in maximum inner ellipse, be that screw can not penetrate vertebra because when implementing pedicle of vertebral arch operation Nut cortex bone, thus subtract on the basis of maximum inner ellipse pedicle of vertebral arch thickness of cortex of bone and drilling offset distance obtain it is concentric ellipse Circle, the pedicle of vertebral arch body that can implement to perform the operation is only, as long as pedicle screw enters to follow closely scope and fallen in concentration ellipse during operation All it is allowed, it has the tolerance band of certain error.
In summary, what is proposed in preparation method of the present invention carries out second-order correction and acquisition pedicle of vertebral arch maximum to entering to follow closely direction The technology path of inscribed Elliptic Cylinder, it is the built-in work(of the anatomic morphological based on pedicle of vertebral arch, Least Square Theory and CAD software Can and carry out, effectively improve put nail channel planning quality and efficiency.

Claims (4)

1. the personalized pedicle of vertebral arch with Quick-change drill bush puts nail bit mould, it is characterized in that:Including body (1) and drill bushing (2);Body (1) Lower end is provided with bone binding face (11) and bottom surface (15), and upper end, which is provided with, puts nail plane (12), and body (1) front and rear sides wall, which is provided with, to be referred to Load mould (14), body (1) is interior to put nail channel (13) provided with two, puts nail channel (13) one end and penetrates to nail plane (12) is put, separately One end is penetrated to bone binding face (11);Drill bushing (2), which is arranged on, to be put in nail channel (13), and the two forms interference fits;
Drill bushing (2) is shorter in length than the length for putting nail channel (13), is put when drill bushing (2) is arranged in nail channel (13), it is logical to put nail (13) one sections of road contacts with drill bushing (2), and another section does not contact with drill bushing (2), puts nail channel (13) does not contact with drill bushing (2) one Section is chip removal chamber (133), and chip removal chamber (133) is communicated to bottom surface (15);
Bone binding face (11) can attach with the profile of targeted vertebra (31) vertebral plate, transverse process rear portion and spinous process root dorsal part to coincide;When When bone binding face (11) attaches identical with targeted vertebra (31), the central axis (132) and targeted vertebra of nail channel (13) are put (31) axis of the maximum inscribed Elliptic Cylinder of pedicle of vertebral arch overlaps;
Wall is provided with transverse process with body (1) bottom surface (15) intersection and avoids chamfering (16) at left and right sides of body (1);Bone binding face (11) The position on corresponding targeted vertebra (31) spinous process top is provided with spinous process and avoids groove (17);The corresponding adjacent vertebrae of bone binding face (11) (9) position of processus articular superior is provided with processus articular superior and avoids groove (18);The adjacent vertebrae (9) is under targeted vertebra (31) Side and the one piece vertebra adjacent with targeted vertebra (31).
2. a kind of prepare the method that the personalized pedicle of vertebral arch with Quick-change drill bush puts nail bit mould as claimed in claim 1, its feature It is to comprise the following steps:
S01, obtain targeted vertebra medical image:Transfer spiral CT examination data or nuclear magnetic resonance check before patient's diagnosis Data, the data of operative region targeted vertebra are selected, save as the recognizable form of medical image software;
S02, reconstruct the threedimensional model and central point point set of targeted vertebra:The medical image of targeted vertebra is imported into medical science shadow As software Mimics, rebuild the threedimensional model of targeted vertebra, then obtain the central point point set of targeted vertebra, central point point set by Away from the discrete point composition for a, threedimensional model and central point point set are saved as into STL forms, IGS forms respectively;
In this step, a interval is 0.01mm~0.1mm;
S03, create and to be modified once enter staple line:Threedimensional model and central point point set data file are imported into reverse engineering software In Imageware, the central point point set in the pedicle of vertebral arch length range of side is then chosen, creates nurbs curve, it is bent in NURBS M equidistant point is taken on line, and makes tangent line of the nurbs curve in this m position, cross this m point be respectively created perpendicular to A m normal sections of each tangent line, n including being extracted in a m normal sections comprising pedicle isthmus are once abscissused Face, nurbs curve form n intersection point with this n normal sections, obtain the least-squares line of this n intersection point, as once Enter staple line;
In this step, n >=7, m >=n;
S04, create it is secondary enter staple line:By n intersection point in S03 steps, it is respectively created perpendicular to the n individual two for once entering staple line Secondary normal section;Extract the outer contour of pedicle of vertebral arch respectively on n secondary normal sections, be then created that in each outer contour Maximum inscribed circle, the center of circle of each maximum inscribed circle is sequentially connected, forms a space broken line, obtain the minimum of the space broken line Two multiply straight line, as it is secondary enter staple line;
In this step, it is secondary enter staple line be that final pedicle screw enters to follow closely route;
S05, it is determined that along it is secondary enter staple line direction the maximum inscribed Elliptic Cylinder of pedicle of vertebral arch cross section:Pass through the n in S03 steps Individual intersection point, be respectively created perpendicular to it is secondary enter staple line n three times normal sections, extract vertebra on normal section respectively three times at this n The outer contour of nut, then by the n outer contour extracted along it is secondary enter staple line vector direction, near target vertebra Bone centrum is projected on normal section three times, is internally formed a closed interval after projection superposition, is made in the closed interval Maximum inner ellipse, the maximum inner ellipse be along it is secondary enter staple line direction the maximum inscribed Elliptic Cylinder of pedicle of vertebral arch horizontal stroke Section;
S06, determine pedicle screw and put the interval of nail channel diameter:Using the center of the maximum inner ellipse in The heart, r are semi-minor axis length, and h is semimajor axis length, make concentration ellipse in maximum inner ellipse, and ensure the short of concentration ellipse Axle is overlapping with the short axle of maximum inner ellipse, by the minor axis length of the concentration ellipse and pharmaceuticals industry standard YY0018-2002 institutes The external thread diameter size of defined metal bone screw is compared and downward rounding, determines pedicle screw external thread diameter D1, the diameter of thread d2 taken corresponding to d1 is looked into, the basic size using d2 as drill bushing internal diameter, using d2+2 δ as drill bushing external diameter Basic size, then determine to put nail channel diameter with putting the matching relationship of nail channel according to drill bushing;
In this step, r=b-x-y;h=c-x-y;B is the semi-minor axis length of maximum inner ellipse, and c is the half of maximum inner ellipse Long axis length, x are the statistical value of targeted vertebra pedicle of vertebral arch thickness of cortex of bone, and y is the drilling offset distance of body, and y interval is 0.3~0.5mm;δ is the wall thickness of drill bushing, and δ interval is 1.5~1.75mm;
S07, S03~S06 is repeated in, obtains the secondary of the opposite side pedicle of vertebral arch relative with " side pedicle of vertebral arch " in S03 steps Enter staple line, pedicle screw and the interval for putting nail channel diameter;
S08, establish this body three-dimensional models:The threedimensional model file of targeted vertebra and its adjacent vertebrae is imported into PRO/E;Root According to the form of targeted vertebra, size and position relationship with adjacent vertebrae, establish body initial configuration model, further according to it is secondary enter Nail channel diameter is put in staple line linear equation and selection, is established on body initial configuration model and is put nail channel, Ran Hou The body initial configuration model for targeted vertebra and band being put in Mimics nail channel is matched, using Boolean calculation under body The reverse curved surface of end generation targeted vertebra locating surface, as the bone binding face of body, so as to realize the foundation of this body three-dimensional models;
S09, manufacture the personalized pedicle of vertebral arch with Quick-change drill bush and put nail bit mould:By designed body three-dimensional models 3D printing skill Art is manufactured, and designed drill bushing is also manufactured, while produces the 3D printing model of targeted vertebra, is easy to doctor Preoperative experiment and assessment.
3. the method that the personalized pedicle of vertebral arch with Quick-change drill bush puts nail bit mould is prepared as claimed in claim 2, it is characterized in that:Step In rapid S08, when establishing body initial configuration model, consider the convenience of clamping, set finger pressure to cheat on the wall of body front and rear sides, Holding position when nail bit die worker makees is put as the personalized pedicle of vertebral arch with Quick-change drill bush in finger pressure hole.
4. the method that the personalized pedicle of vertebral arch with Quick-change drill bush puts nail bit mould, its feature are prepared as claimed in claim 2 or claim 3 It is:In step S08, when establishing body initial configuration model, carry out empty avoiding at three and handle, empty avoiding, which is handled, at described three is included in this Wall sets transverse process to avoid chamfering with bottom surface intersection at left and right sides of body, fixed to avoid the transverse process position of adjacent vertebrae from installing body The interference of position;The position that bone binding face corresponds to targeted vertebra spinous process top sets spinous process to avoid groove, to avoid spinous process laterally convex Play the interference effect to the positioning of bone binding face curved surface;It is recessed that bone binding face corresponds to adjacent vertebrae processus articular superior position processus articular superior avoidance Groove, to avoid the interference effect that the relative motion change in location between targeted vertebra and adjacent vertebrae positions to bone binding face curved surface.
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CN2840938Y (en) * 2005-07-29 2006-11-29 太原市绿波机电科技有限公司 Vertebral body internal fixation guider and depthkeeping drill bit and pedicle screw device
CN101390773B (en) * 2007-09-19 2010-11-10 陆声 Production method of navigation template for positioning the pediculus arcus vertebrae
US20120136398A1 (en) * 2010-05-28 2012-05-31 Jean-Pierre Mobasser Awl-tipped pedicle screw and method of implanting same
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