CN106510833A - Double-side positioning type pediculus arcus vertebrae screw implanting aiming device and preparation method thereof - Google Patents
Double-side positioning type pediculus arcus vertebrae screw implanting aiming device and preparation method thereof Download PDFInfo
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- CN106510833A CN106510833A CN201611011800.9A CN201611011800A CN106510833A CN 106510833 A CN106510833 A CN 106510833A CN 201611011800 A CN201611011800 A CN 201611011800A CN 106510833 A CN106510833 A CN 106510833A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/90—Guides therefor
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B33Y80/00—Products made by additive manufacturing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B2017/564—Methods for bone or joint treatment
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Abstract
The invention relates to a double-side positioning type pediculus arcus vertebrae screw implanting aiming device and a preparation method thereof. The preparation method comprises the following steps of obtaining targeted vertebra medical image data; reconstructing a three-dimensional model and a point set of center points of a targeted vertebra; creating a primary screw feeding line to be corrected; creating a secondary screw feeding line; determining the diameter of a maximum inscribed cylinder of the pediculus arcus vertebrae in the direction along the secondary screw feeding line; determining the value taking interval of the diameter of a pediculus arcus vertebrae screw and a screw implanting passage; building a body three-dimensional model; and manufacturing the double-side positioning type pediculus arcus vertebrae screw implanting aiming device. By using the preparation method provided by the invention, the double-side positioning type pediculus arcus vertebrae screw implanting aiming device which has good attaching fitness with a target vertebra positioning curve surface and has the high-precision screw implanting passage can be manufactured. An operator can accurately and fast perform the pediculus arcus vertebrae screw inner fixation operation by using the aiming device; the operation efficiency is improved; and the precision and the safety of the operation are also guaranteed.
Description
Technical field
The present invention relates to technical field of medical instruments, more particularly to a kind of bilateral location type pedicle of vertebral arch put nail sight and its
Preparation method.
Background technology
In pedicle screw, fixed surgical indication is applied to the tumor of spinal cord of backbone, retrogression pathological changes, rheumatoid and closes
Section inflammation and infectious diseases, especially in treatment vertebral slippage reset, corrective procedure, pedicle of Vertebral Arch Fixation is the most reliable
Fixed form.As pedicle screw can play three-dimensional fixation, with mechanical strength it is high, fixed and Fusion levels are few,
The advantages of deformity of spine rectification effect is good, its clinical practice are more and more extensive.
Biomechanics experiment proves that only the dissection major axis along pedicle of vertebral arch is inserted screw 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, on the inside of pedicle of vertebral arch is
Canalis spinalis, lower section are nerve root, and can the success or failure of the pedicle screw internal fixation operation of pedicle it is critical only that 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 and can cause spinal cord, nerve damage, internal organs, blood
Pipe is damaged, or even threat to life.And, thoracic vertebrae, the pedicle diameter of cervical vertebra are gradually reduced from lumbar vertebrae upwards, cause operation difficult
Degree increase, operation risk are improved.And the vertebral arch root morphology of individual has larger variability, cause screw to put nail fault rate and carry
It is high.Cause the clinical report of the complication such as neurotrosis, pedicle screw loosening as 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
Lead the implantation of implants, the problem that always basis and clinical research are extremely paid close attention to both at home and abroad.
At present, determine that pedicle screw enters to follow closely angle and the main method of entry point and has：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 accurately says it is that the opposed nail channel of feel and pedicle probe by patient is felt to ensure pedicle of vertebral arch judging
Screw is accurately inserted, and the clinical experience of doctor is required higher, and precision is difficult to ensure that.Vertebral lamina fenestration inevitably increases
Plus operating time and intraoperative blood loss.The operating time of X-ray examination auxiliary law is longer, the x-ray spoke that patient and medical personnel are subject to
The amount of penetrating is larger.Gradually applied during computer navigation method is fixed in pedicle screw in recent years, using the real-time vertebra of patient
Nut image information carrys out guided operation, reduces operation risk, reduces the time that doctor and patient contacts ray, with larger excellent
Gesture, but navigator is expensive, complex operation, and clinical popularization still suffers from difficulty.Navigation template method is based on 3D printing technique
Navigation template is produced, with to quick response and the efficiency-cost ratio advantage of performing the operation, existing individuation navigation template is primarily present three
The problem of aspect：One is that template thickness is relatively thin, rigid poor, is held in being not easy to art, and during drilling, template is also easy to produce deformation and shakes
It is dynamic；Two be the navigation template without sleeve conduit is easy to wear and fusing, and between its sleeve of the navigation template with sleeve and template
Coordinate for gap and have relative rotation, this can affect orientation accuracy and using effect；Three is the planning that pedicle of vertebral arch puts nail channel
Lack effectively theoretical and means to support, its optimization method, operating efficiency and planning effect have much room for improvement.
Therefore, need badly and design that a set of energy is accurate, efficiently plan pedicle screw entry point, insert angle, diameter with
The method of length, and " nail sight is put in personalization " for being applied to perform the operation is prepared based on the result of calculation of the method, in order to
Insert pedicle screw in pedicle screw internal fixation operation safety and precise, realize the multiple again of vertebra biomechanics characteristic
System, improves 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 bilateral location type pedicle of vertebral arch and put nail
Sight and preparation method thereof, puts nail sight by bilateral location type pedicle of vertebral arch, and patient can be fast in pedical screw instrumentation
Speed, accurately implement into nail, realize complicated operation safe, key operation simplification, apparatus cost-effective.
The technical scheme is that：Bilateral location type pedicle of vertebral arch puts nail sight, including body and fairlead；Under body
End is provided with bone binding face and bottom surface, and upper end is provided with puts nail plane, and this is provided with two in vivo and puts nail channel, puts the insertion of nail channel one end
To nail plane is put, other end insertion is to bottom surface；Fairlead is arranged on and puts in nail channel, and the two forms interference fits.
Further technical scheme is the present invention：It is shoulder hole to put nail channel, is provided with step surface, on fairlead outer wall in which
It is provided with ring-shaped step；Put in nail channel when fairlead is arranged on, fairlead by ring-shaped step thereon with put in nail channel
Step surface contacts and positions.
Further technical scheme is the present invention：Before and after body, two side is provided with finger pressure hole.
Further technical scheme of the invention is：Fairlead is shorter in length than the length for putting nail channel, when fairlead is pacified
Be mounted in and put in nail channel, put one section of nail channel and contact with fairlead, another section is not contacted with fairlead, put nail channel not with guiding
One section of set contact is chip removal chamber, and chip removal chamber is communicated to bottom surface.
Further technical scheme of the invention is：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 is attached and is coincide；When bone binding face and targeted vertebra are attached coincide, the central axis and target of nail channel are put
The axis of pedicles of vertebrae maximum inscribed cylinder overlaps；The adjacent vertebrae is below targeted vertebra and and targeted vertebra
One piece of adjacent vertebra.
Further technical scheme of the invention is：Body left and right sides wall is provided with transverse process avoidance with body bottom surface intersection
Chamfering；The position on bone binding face correspondence targeted vertebra spinous process top is provided with spinous process and avoids groove；Bone binding face correspondence adjacent vertebrae
The position of processus articular superior is provided with processus articular superior and avoids groove.
The preparation method that described bilateral location type pedicle of vertebral arch puts nail sight is as follows：
S01, obtains targeted vertebra medical image：Transfer spiral CT examination data or nuclear magnetic resonance check before patient's diagnosis
Data, select the data of operative region targeted vertebra, save as the discernible form of medical image software；
S02, reconstructs 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
Constitute away from the discrete point for a, threedimensional model and central point point set are saved as into STL forms, IGS forms respectively；
In this step, the interval of a is 0.01mm～0.1mm；
S03, what establishment was 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, create nurbs curve, it is bent in NURBS
M equidistant point is taken on line, and makes tangent line of the nurbs curve this m point position, cross this m point be respectively created perpendicular to
A m normal section of each tangent line, extracts the n comprising pedicle isthmus in a m normal section and once abscissuses
Face, nurbs curve form n intersection point with this n normal section, obtain the least-squares line of this n intersection point, as once
Enter staple line；
In this step, n >=7, m >=n；The isthmus is the most narrow one section of region of pedicle of vertebral arch, account for pedicle of vertebral arch total length 5%～
15%；
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 on n secondary normal section respectively, be then created that in each outer contour
Maximum inscribed circle A, the center of circle of each maximum inscribed circle A is sequentially connected, and is formed a space broken line, is obtained the space broken line most
A young waiter in a wineshop or an inn takes advantage of straight line, as it is secondary enter staple line；
In this step, it is secondary enter staple line be final pedicle screw and enter to follow closely route；
S05, it is determined that along it is secondary enter staple line direction pedicle of vertebral arch maximum inscribed circle cylinder diameter：Handed over by n in S03 steps
Point, be respectively created perpendicular to it is secondary enter staple line n three normal sections, extract pedicle of vertebral arch respectively on this n three normal sections
Outer contour, then by the n outer contour for extracting along it is secondary enter staple line vector direction, near targeted vertebra vertebra
Projected on three normal sections of body, a closed interval is internally formed after projection superposition, is made in the closed interval most
The diameter of big inscribed circle B, maximum inscribed circle B be along it is secondary enter staple line direction pedicle of vertebral arch maximum inscribed circle cylinder diameter；
S06, determines pedicle screw and puts the interval of nail channel diameter：Maximum inscribe is made inwardly by offset distance value of x+y
The concentric circles of circle B, by concentric diameter of a circle and the outer spiral shell of the metal bone screw of pharmaceuticals industry standard YY0018-2002 defined
Line diameter dimension is compared, and rounding downwards, determines pedicle screw external thread diameter d1, looks into the screw thread taken corresponding to d1 little
Footpath d2, using d2 as fairlead internal diameter basic size, using d2+2 δ as fairlead external diameter basic size, then according to leading
Determine with the matching relationship for putting nail channel to set and put nail channel diameter；
In this step, statistical values of the x for targeted vertebra pedicle of vertebral arch thickness of cortex of bone, when targeted vertebra is cervical vertebra, the interval of x
For 0.8～1.4mm, when targeted vertebra is thoracic vertebrae, the interval of x is 1.2～1.6mm, and when targeted vertebra is lumbar vertebrae, x's takes
It is 1.5～2.5mm that value is interval；Y is body because of manufacture, installation and using the possible caused drilling offset distance of error, the interval of y
For 0.3～0.5mm；Wall thickness of the δ for fairlead, the interval of δ is 1.5～1.75mm；
S07, is repeated in S03～S06, 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 put the interval of nail channel diameter；
S08, sets up this body three-dimensional models：The threedimensional model file of targeted vertebra and its adjacent vertebrae is imported in PRO/E；Root
Position relationship according to the form of targeted vertebra, size and with adjacent vertebrae, sets up body initial configuration model, further according to it is secondary enter
Nail channel diameter is put in staple line linear equation and selection, sets up put nail channel, Ran Hou on body initial configuration model
The body initial configuration model that targeted vertebra and band put nail channel is matched in Mimics, using Boolean calculation under body
End generates the reverse curved surface of 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 bilateral location type pedicle of vertebral arch put nail sight：This body three-dimensional models for designing are manufactured with 3D printing technique
Out, and by the fairlead for designing also manufacture, while producing the 3D printing model of targeted vertebra, be easy to doctor preoperative
Test and assessment.
It is preferred that, in step S08, when setting up body initial configuration model, it is considered to the convenience of clamping, the both sides before and after body
Finger pressure hole is set on wall, and holding position when nail sight works is put in finger pressure hole as bilateral location type pedicle of vertebral arch.
It is preferred that, in step S08, when setting up body initial configuration model, carry out empty avoiding at three and process, at described three at empty avoiding
Reason is included in body left and right sides wall and arranges transverse process avoidance chamfering with bottom surface intersection, to avoid the transverse process position pair of adjacent vertebrae
Body installs the interference of positioning；The position on bone binding face correspondence targeted vertebra spinous process top arranges spinous process and avoids groove, to avoid
The interference effect that spinous process lateral protrusions are positioned to bone binding face curved surface；Bone binding face correspondence adjacent vertebrae processus articular superior is closed on position
Section is prominent to avoid groove, to avoid what the relative motion change in location between targeted vertebra and adjacent vertebrae was positioned to bone binding face curved surface
Interference effect.
The present invention is had the advantage that compared with prior art：
1st, using the preparation method in the present invention, can produce to attach with targeted vertebra positioning curved surface and coincide good and have high-precision
Degree is put the bilateral location type pedicle of vertebral arch of nail channel and puts nail sight.Patient can accurately and rapidly implement vertebral arch by this sight
Root screw internal fixation, had both improved procedure efficiency, had 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, with obvious personalized customization feature.Body interior put nail channel space angle and
Diameter is calculated according to the respective algorithms in preparation method.Can be in targeted vertebra vertebral arch by the fairlead of body interior
The thread Pilot hole of pedicle screw is got out in root, the pedicle screw being implanted into by thread Pilot hole can both ensure not wearing out vertebral arch
Root skin matter, ensures that screw has maximum gauge in the range of vertebral arch radical space is allowed, so as to ensure to plant to greatest extent
There is after entering excellent biomechanics characteristic and firm three-dimensional fixed effect, the multiple again of vertebral joint biomechanics characteristic is realized
System.
3rd, finger pressure hole is provided with before and after body on two side, meets ergonomics, can be when sight works easily
Held and pressed, not only can effectively be reduced the vibration of sight, moreover it is possible to be effectively prevented sight and targeted vertebra it
Between, there is skidding between patient's finger and sight.
4th, body puts the fairlead that metal material is provided with nail channel, and fairlead is shorter in length than the length for putting nail channel
Degree, is put in nail channel when fairlead is arranged on, puts one section of nail channel and contacted with fairlead, and another section is not contacted with fairlead, is put
Nail channel do not contact with fairlead one section is chip removal chamber, and chip removal chamber can accommodate the bone bits for getting out, can be prevented effectively from again and spud in
When scratch of the drill edge wedge angle to fairlead endoporus.Fairlead carbon quenched and tempered steel (45 steel or medium carbon alloy steel 40Cr) using in
Prepare so as to both with good comprehensive mechanical performance and wearability, be easy to use definite value reamer again and its small size internal diameter is entered
Row Precision Machining.In operation, fairlead not only gets out screw thread bottom outlet in pedicle of vertebral arch for drill bit and provides accurate guiding work
With, and good dimensional stability can be kept, so as to ensure that high-precision cooperation (chip clearance is formed between drill bit and fairlead
With the ratio of bit diameter be 0.5～1).Metal fairlead can quick dispatch, reusable, both improved procedure efficiency, dropped again
Low apparatus cost.
5th, body is provided with optimization structure at three：Body left and right sides wall is provided with transverse process with bottom surface intersection and avoids chamfering,
Can avoid the transverse process position of adjacent vertebrae that the interference for positioning is installed to body；The portion on bone binding face correspondence 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 avoidance groove, can avoid relative between targeted vertebra and adjacent vertebrae
Interference effect of the movement position change to bone binding face curved surface positioning.
Below in conjunction with figure, the invention will be further described with embodiment.
Description of the drawings
Fig. 1 is the front view that bilateral location type pedicle of vertebral arch puts nail sight；
Top views of the Fig. 2 for Fig. 1；
Left views of the Fig. 3 for Fig. 1；
Fig. 4 is the dimensional structure diagram that bilateral location type pedicle of vertebral arch puts nail sight；
Fig. 5 is the use state schematic diagram that bilateral location type pedicle of vertebral arch puts nail sight；
Structural representations of the Fig. 6 for body；
Fig. 7 is the position relationship schematic diagram of targeted vertebra and adjacent vertebrae；
Matching status schematic diagrames of the Fig. 8 for the threedimensional model and its central point point set of targeted vertebra；
Fig. 9 is the to be modified generation view for once entering staple line；
Figure 10 be it is secondary enter staple line generation view；
Figure 11 is the generation view of three normal sections；
Figure 12 enters nail channel for safety and generates view.
Explanation：For the structure of more intuitive show ontology, Fig. 6 adopt at nail channel broken section putting.
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；Fairlead 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；Most
Big inscribed circle A37；Space broken line 38；It is secondary enter staple line 39；Three normal sections 40；Maximum inscribed circle B41；Concentric circles 42；It is adjacent
Vertebra 9；Transverse process 91；Processus articular superior 92.
Specific embodiment
Embodiment 1：
As shown in figs. 1 to 6, bilateral location type pedicle of vertebral arch puts nail sight, including body 1 and fairlead 2.
1 lower end of body is provided with bone binding face 11 and bottom surface 15, and upper end is provided with puts nail plane 12.Body is provided with two and puts nail
Passage 13, puts 13 one end insertion of nail channel to nail plane 12 is put, and other end insertion is 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 is attached and is coincide.It coincide when bone binding face 11 is attached with targeted vertebra 31
When, the central axis 132 for putting nail channel 13 is overlapped with the axis of 31 pedicle of vertebral arch maximum inscribed cylinder of targeted vertebra.
Fairlead 2 is arranged on and puts in nail channel 13, and the two forms interference fits, that is, form gap or interference fit is (optional
Select H8/js7 or H8/k7), but gap value or the equal very little of the magnitude of interference, while orientation accuracy is ensured it is easily installed again and dismantles.
It is preferred that, before and after body 1, the edge of two side is provided with finger pressure hole 14.
It is preferred that, it is shoulder hole to put nail channel 13, and step surface 131 is provided with which, and 2 outer wall of fairlead is provided with ring-shaped step
21；Put in nail channel 13 when fairlead 2 is arranged on, fairlead 2 by ring-shaped step 21 thereon with put the platform in nail channel 13
Terrace 131 contacts and is axially located.
It is preferred that, as shown in Fig. 2,7,1 left and right sides wall of body is provided with transverse process with 15 intersection of bottom surface and avoids chamfering 16, can keep away
91 position of transverse process for exempting from adjacent vertebrae 9 is installed by the interference of positioning to body；On correspondence 31 spinous process 311 of targeted vertebra 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 11 curved surface of bone binding face；
The position of correspondence 9 processus articular superior 92 of adjacent vertebrae 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 is positioned to 11 curved surface of bone binding face.
The preparation method that described bilateral location type pedicle of vertebral arch puts nail sight is as follows：
S01, obtains targeted vertebra medical image：Transfer spiral CT examination data or nuclear magnetic resonance check before patient's diagnosis
Data, select the data of operative region targeted vertebra, save as the recognizable forms of medical image software Mimics.
S02, reconstructs the threedimensional model and central point point set of targeted vertebra：The medical image of targeted vertebra 31 is imported
Medical image software Mimics, takes filtering, noise reduction means 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, sets up mask, rebuilds the threedimensional model of targeted vertebra 31, then by Mimics built-in " center line plan
Conjunction " function generates the central point point set 32 of targeted vertebra 31, and discrete point of the central point point set 32 by spacing for 0.05mm is constituted, will
The threedimensional model and central point point set 32 of targeted vertebra 31 saves as STL forms, IGS forms respectively.
In this step, the interval of a is 0.01mm～0.1mm；The central point point set 32 is 31 barycenter of targeted vertebra
The point set of composition.
S03, what establishment was to be modified once enter staple line：The threedimensional model of targeted vertebra 31 and central point point set 32 are imported inverse
To in 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, and equidistant 21 point is taken on nurbs curve, and nurbs curve 33 is made in this 21 point positions
Tangent line, crosses this 21 points and is respectively created 21 normal sections 35 perpendicular to each tangent line, extract in 21 normal sections
Go out including 7 normal sections (as shown in Figure 9) including pedicle isthmus；According to nurbs curve and 7 normal sections
The D coordinates value of 7 intersection points, obtains its least-squares line equation based on the M files of Matlab, and paints 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 create in Imageware.The isthmus is one section of most narrow area of pedicle of vertebral arch
Domain, accounts for the 5%～15% of pedicle of vertebral arch total length, on the premise of the densification of center dot spacing, it is easy to obtain in a m normal section.
S04, create it is secondary enter staple line：Created perpendicular to once entering staple line 34 by 7 intersection points formed in S03 steps
7 secondary normal sections 36, extract the outer contour of pedicle of vertebral arch, on 7 secondary normal sections 36 respectively then in each foreign steamer
Maximum inscribed circle A37 is created that in profile, the center of circle of 7 maximum inscribed circle A37 is sequentially connected, form a space broken line 38
(as shown in Figure 10)；The least-squares line equation of space broken line 38 is obtained based on the M files of Matlab；In Imageware
Draw 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 final pedicle screw and enter to follow closely route.
S05, it is determined that along it is secondary enter staple line direction pedicle of vertebral arch maximum inscribed circle cylinder diameter：By 7 in S03 steps
Individual intersection point, be respectively created perpendicular to it is secondary enter staple line 39 7 three normal sections 40, carried on 7 three normal sections 40 respectively
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 three normal sections 40 near 31 centrum of targeted vertebra, after 7 projection superpositions, be internally formed a closing
Interval (as shown in figure 12), makes the maximum inscribed circle B41 of the closed interval, and the diameter 8.6mm of maximum inscribed circle B41 is along two
It is secondary enter staple line direction pedicle of vertebral arch maximum inscribed circle cylinder diameter.
S06, determines pedicle screw and puts the interval of nail channel diameter：Maximum is made inwardly by offset distance value of 2mm
The concentric circles 42 (as shown in figure 12) of inscribed circle B41,42 a diameter of 4.6mm of concentric circles, by concentric circular diameter 4.6mm and medicine
Professional standard YY0018-2002《Synosteosis implant metal bone screw》The external thread diameter of the metal bone screw of defined
Size is compared, and rounding downwards, inquires about and determine model HA4.5 of pedicle screw, and its external thread diameter d1 is
4.5mm, diameter of thread d2 are 3mm, so that it is determined that the basic size of fairlead internal diameter is equal with the bit diameter for getting out thread Pilot hole
For 3mm；Using d2+2 δ (the wall thickness δ of fairlead is 1.5mm) as the basic size of fairlead external diameter, so that it is determined that putting nail channel
Diameter and the basic size of fairlead external diameter be 6mm.
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, calculates offset distance value for 2mm according to formula x+y.
S07, is repeated in S03～S06, obtains the opposite side pedicle of vertebral arch relative with " side pedicle of vertebral arch " in S03 steps
It is secondary to enter staple line, pedicle screw and to put the interval of nail channel diameter.
S08, sets up the threedimensional model of body：By threedimensional model file (the STL lattice of targeted vertebra 31 and its adjacent vertebrae 9
Formula) import in PRO/E；Form, size according to targeted vertebra 31 and the position relationship with adjacent vertebrae 9, set up at the beginning of 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
Set up on beginning structural model and put nail channel 13, the body that targeted vertebra 31 and band are put nail channel 13 in Mimics then is initial
Structural model is matched, and generates the reverse curved surface of targeted vertebra 31 locating surface in 1 lower end of body using Boolean calculation, 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 bilateral location type pedicle of vertebral arch put nail sight：Bilateral location type pedicle of vertebral arch is put into the three-dimensional of nail sight
Model file (STL forms) is imported in 3D printing software Cura, carries out 3D printing manufacture, and the fairlead for designing also is manufactured
Out, while producing the 3D printing model of targeted vertebra, it is easy to the preoperative test of doctor and assessment.
The cad technique of uniqueness is employed in preparation method of the present invention to the planning for putting nail channel of body, is effectively lifted
The quality and efficiency of planning.The maximum inscribed circle cylinder that it is critical only that searching pedicle of vertebral arch of nail channel is put in planning, determines according to this
Pedicle screw enters to follow closely direction and screw diameter.
Central point point set data in the pedicle of vertebral arch length range that this preparation method is automatically generated in being primarily based on Mimics,
The pedicle of vertebral arch center line of nurbs curve form is created in Imageware, in this, as seeking pedicle of vertebral arch maximum inscribed circle cylinder
The primary data of axis, avoiding problems blindness and arbitrariness to pedicle of vertebral arch maximum inscribed circle cylinder initial plan.
Next if considering only with isthmus to the normal of nurbs curve normal section to set pedicle of vertebral arch maximum inscribed circle
The axis vector of cylinder, then in pedicle of vertebral arch length range do not have ergodic, therefore n characteristic point for choosing nurbs curve asked
Solve and draw out least-squares line, as staple line is once entered, complete to enter to follow closely direction that is, maximum inscribed circle column axis to
The first time amendment of amount.
It should be noted that as important Mathematical Modeling, least square method because theoretical ripe, algorithm is simple and easy to do
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 pedicle of vertebral arch maximum inscribed circle cylinder is provided just
Profit, but if entering follow closely direction as final using which, then due to the complexity of pedicle of vertebral arch anatomic morphological occur it is larger to
Amount error, the center of circle of the maximum inscribed circle in n secondary normal section are larger at one along the projective distribution for once entering staple line vector
In the range of, this larger dislocation causes the diameter of the pedicle of vertebral arch maximum inscribed circle cylinder made less than normal, therefore correct feasible
Way is the circle center line connecting by asking for maximum inscribed circle A, further ask for the least-squares line of the line as it is secondary enter
Staple line, completes, to entering to follow closely second amendment in direction that is, maximum inscribed circle column axis vector, to obtain in the vector direction
Bigger pedicle of vertebral arch maximum inscribed circle cylinder diameter.
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
Imperial palace connects cylinder diameter, can produce slight broken wall phenomenon, therefore the pedicle of vertebral arch outer contour that first will be extracted on three normal sections
Along it is secondary enter staple line vector direction project and be superimposed, ask for the maximum inscribed circle B of its internal closed interval, as along it is secondary enter nail
The cross section of the maximum inscribed circle cylinder in line direction, the Virtual Test Validation security of this method.
Then to make concentric circles in maximum inscribed circle B, when being because that implementing pedicle of vertebral arch performs the operation, screw can not penetrate vertebral arch
Root cortex bone, therefore the concentric circles that pedicle of vertebral arch thickness of cortex of bone and drilling offset distance are obtained is deducted on the basis of maximum inscribed circle B,
It is the pedicle of vertebral arch body that can implement to perform the operation.
In sum, 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 circle cylinder, is the build-in function based on the anatomic morphological of pedicle of vertebral arch, Least Square Theory and CAD software
And carry out, effectively improve the quality and efficiency for putting nail channel planning.
Claims (10)
1. bilateral location type pedicle of vertebral arch puts nail sight, it is characterized in that：Including body (1) and fairlead (2)；Body (1) lower end
Be provided with bone binding face (11) and bottom surface (15), upper end is provided with to put and two is provided with nail plane (12), body (1) and puts nail channel
(13), put nail channel (13) one end insertion to put nail plane (12), other end insertion to bone binding face (11)；Fairlead (2) is pacified
It is mounted in and puts in nail channel (13), the two forms interference fits.
2. bilateral location type pedicle of vertebral arch as claimed in claim 1 puts nail sight, it is characterized in that：It is ladder to put nail channel (13)
Hole, is provided with step surface (131) in which, fairlead (2) outer wall is provided with ring-shaped step (21)；When fairlead (2) is installed in putting nail
In passage (13), fairlead (2) is contacted with the step surface (131) put in nail channel (13) by ring-shaped step (21) thereon
And position.
3. bilateral location type pedicle of vertebral arch as claimed in claim 2 puts nail sight, it is characterized in that：Both sides before and after body (1)
Wall is provided with finger pressure hole (14).
4. bilateral location type pedicle of vertebral arch as claimed in claim 3 puts nail sight, it is characterized in that：The length of fairlead (2) is short
In the length for putting nail channel (13), when fairlead (2) is installed in putting in nail channel (13), (13) one sections of nail channel and fairlead are put
(2) contact, another section contact with fairlead (2), it is chip removal chamber to put one section that nail channel (13) do not contacted with fairlead (2)
(133), chip removal chamber (133) are communicated to bottom surface (15).
5. the bilateral location type pedicle of vertebral arch as any one of claim 1-4 puts nail sight, it is characterized in that：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 and coincide；When bone binding face (11)
When attaching identical with targeted vertebra (31), the central axis (132) for putting nail channel (13) is maximum with targeted vertebra (31) pedicle of vertebral arch
The axis of inscribed circle post overlaps；The adjacent vertebrae (9) be below targeted vertebra (31) and with targeted vertebra (31) phase
One piece of adjacent vertebra.
6. the bilateral location type pedicle of vertebral arch as described in claim 1-4 puts nail sight, it is characterized in that：Body (1) left and right sides
Wall is provided with transverse process with body (1) bottom surface (15) intersection and avoids chamfering (16)；Bone binding face (11) correspondence targeted vertebra (31) spine
The position on prominent (311) top is provided with spinous process and avoids groove (17)；Bone binding face (11) correspondence adjacent vertebrae (9) processus articular superior (92)
Position be provided with processus articular superior avoid groove (18).
7. bilateral location type pedicle of vertebral arch as claimed in claim 5 puts nail sight, it is characterized in that：Body (1) left and right sides wall
Transverse process is provided with body (1) bottom surface (15) intersection and avoids chamfering (16)；Bone binding face (11) correspondence targeted vertebra (31) spinous process
(311) position on top is provided with spinous process and avoids groove (17)；Bone binding face (11) correspondence adjacent vertebrae (9) processus articular superior (92)
Position is provided with processus articular superior and avoids groove (18).
8. a kind of method that bilateral location type pedicle of vertebral arch prepared as any one of claim 1-7 puts nail sight, its
It is characterized in that, comprises the steps：
S01, obtains targeted vertebra medical image：Transfer spiral CT examination data or nuclear magnetic resonance check before patient's diagnosis
Data, select the data of operative region targeted vertebra, save as the discernible form of medical image software；
S02, reconstructs 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
Constitute away from the discrete point for a, threedimensional model and central point point set are saved as into STL forms, IGS forms respectively；
In this step, the interval of a is 0.01mm～0.1mm；
S03, what establishment was 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, create nurbs curve, it is bent in NURBS
M equidistant point is taken on line, and makes tangent line of the nurbs curve this m point position, cross this m point be respectively created perpendicular to
A m normal section of each tangent line, extracts the n comprising pedicle isthmus in a m normal section and once abscissuses
Face, nurbs curve form n intersection point with this n normal section, obtain the least-squares line of this n intersection point, as once
Enter staple line；
In this step, n >=7, m >=n；The isthmus is the most narrow one section of region of pedicle of vertebral arch, account for pedicle of vertebral arch total length 5%～
15%；
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 on n secondary normal section respectively, be then created that in each outer contour
Maximum inscribed circle A, the center of circle of each maximum inscribed circle A is sequentially connected, and is formed a space broken line, is obtained the space broken line most
A young waiter in a wineshop or an inn takes advantage of straight line, as it is secondary enter staple line；
In this step, it is secondary enter staple line be final pedicle screw and enter to follow closely route；
S05, it is determined that along it is secondary enter staple line direction pedicle of vertebral arch maximum inscribed circle cylinder diameter：Handed over by n in S03 steps
Point, be respectively created perpendicular to it is secondary enter staple line n three normal sections, extract pedicle of vertebral arch respectively on this n three normal sections
Outer contour, then by the n outer contour for extracting along it is secondary enter staple line vector direction, near targeted vertebra vertebra
Projected on three normal sections of body, a closed interval is internally formed after projection superposition, is made in the closed interval most
The diameter of big inscribed circle B, maximum inscribed circle B be along it is secondary enter staple line direction pedicle of vertebral arch maximum inscribed circle cylinder diameter；
S06, determines pedicle screw and puts the interval of nail channel diameter：Maximum inscribe is made inwardly by offset distance value of x+y
The concentric circles of circle B, by concentric diameter of a circle and the outer spiral shell of the metal bone screw of pharmaceuticals industry standard YY0018-2002 defined
Line diameter dimension is compared, and rounding downwards, determines pedicle screw external thread diameter d1, looks into the screw thread taken corresponding to d1 little
Footpath d2, using d2 as fairlead internal diameter basic size, using d2+2 δ as fairlead external diameter basic size, then according to leading
Determine with the matching relationship for putting nail channel to set and put nail channel diameter；
In this step, statistical values of the x for targeted vertebra pedicle of vertebral arch thickness of cortex of bone, drilling offset distances of the y for body, the value area of y
Between be 0.3～0.5mm；Wall thickness of the δ for fairlead, the interval of δ is 1.5～1.75mm；
S07, is repeated in S03～S06, 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 put the interval of nail channel diameter；
S08, sets up this body three-dimensional models：The threedimensional model file of targeted vertebra and its adjacent vertebrae is imported in PRO/E；Root
Position relationship according to the form of targeted vertebra, size and with adjacent vertebrae, sets up body initial configuration model, further according to it is secondary enter
Nail channel diameter is put in staple line linear equation and selection, sets up put nail channel, Ran Hou on body initial configuration model
The body initial configuration model that targeted vertebra and band put nail channel is matched in Mimics, using Boolean calculation under body
End generates the reverse curved surface of 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 bilateral location type pedicle of vertebral arch put nail sight：This body three-dimensional models for designing are manufactured with 3D printing technique
Out, and by the fairlead for designing also manufacture, while producing the 3D printing model of targeted vertebra, be easy to doctor preoperative
Test and assessment.
9. the method that bilateral location type pedicle of vertebral arch puts nail sight is prepared as claimed in claim 8, be it is characterized in that：Step S08
In, when setting up body initial configuration model, it is considered to the convenience of clamping, finger pressure hole, finger pressure are set on two side before and after body
Cheat holding position when nail sight work is put as bilateral location type pedicle of vertebral arch.
10. the bilateral location type pedicle of vertebral arch for preparing as described in claim 9 or 8 puts the method for following closely sight, it is characterized in that：Step
In S08, when setting up body initial configuration model, carry out empty avoiding at three and process, empty avoiding at described three is processed and is included in body or so
Two side arranges transverse process with bottom surface intersection and avoids chamfering, is done with avoiding the transverse process position of adjacent vertebrae from installing positioning to body
Relate to；The position on bone binding face correspondence targeted vertebra spinous process top arranges spinous process and avoids groove, to avoid spinous process lateral protrusions to bone
The interference effect of binding face curved surface positioning；Bone binding face correspondence adjacent vertebrae processus articular superior position processus articular superior avoids groove, with
The interference effect for avoiding the relative motion change in location between targeted vertebra and adjacent vertebrae from positioning bone binding face curved surface.
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| CN109199603A (en) * | 2018-08-31 | 2019-01-15 | 浙江大学宁波理工学院 | A kind of optimal intelligent locating method for setting nail point of pedicle screw |
| 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 |
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