CN109330677A - A kind of personalization atlas and axis pedicle screw navigation template device and preparation method thereof step by step - Google Patents
A kind of personalization atlas and axis pedicle screw navigation template device and preparation method thereof step by step Download PDFInfo
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- 238000002360 preparation method Methods 0.000 title claims description 5
- 238000010079 rubber tapping Methods 0.000 claims abstract description 60
- 238000005553 drilling Methods 0.000 claims abstract description 41
- 230000007246 mechanism Effects 0.000 claims description 96
- 238000000034 method Methods 0.000 claims description 41
- 230000008569 process Effects 0.000 claims description 33
- NJPPVKZQTLUDBO-UHFFFAOYSA-N novaluron Chemical compound C1=C(Cl)C(OC(F)(F)C(OC(F)(F)F)F)=CC=C1NC(=O)NC(=O)C1=C(F)C=CC=C1F NJPPVKZQTLUDBO-UHFFFAOYSA-N 0.000 claims description 21
- 238000013461 design Methods 0.000 claims description 20
- 238000004088 simulation Methods 0.000 claims description 18
- 210000000988 bone and bone Anatomy 0.000 claims description 11
- 238000010146 3D printing Methods 0.000 claims description 10
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- 238000002591 computed tomography Methods 0.000 claims description 3
- 238000007639 printing Methods 0.000 claims description 3
- 230000003362 replicative effect Effects 0.000 claims description 3
- 108010048734 sclerotin Proteins 0.000 abstract description 8
- 230000008859 change Effects 0.000 abstract description 4
- 238000005516 engineering process Methods 0.000 abstract description 2
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/88—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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Abstract
The invention belongs to the field of medical instrument technology, more particularly to a kind of personalized atlas and axis pedicle screw navigation template device step by step, it is characterized by: this system includes " positioning guide plate ", " drilling guide plate " and " tapping guide plate ", above-mentioned template by set nail sequence one by one additional screws merging every single stepping, expand step by step, improves accuracy.Centering guide of the present invention is independently attached on sclerotin, the case where cannot tightly attaching will not occurs with the change of position in art, is set nail accuracy rate and is reached 100%, there is good accuracy.
Description
Technical field
The invention belongs to the field of medical instrument technology more particularly to a kind of personalized atlas and axis pedicle screw to navigate step by step
Plate device and preparation method thereof.
Background technique
Upper cervical spine includes atlas and dentata, is the important feature for maintaining head and body, and the factors such as severe trauma can cause extensive region
Axis fractures, dislocation eventually lead to patient's paralysis, crisis life etc., therefore, it is necessary to being diagnosed, being handled in time, restoring its knot
Structure is stablized.Currently, posterior transpedicle internal fixation by nail-stick system is the ordinary operation for treating atlas axis fracture, dislocation, but due to
Atlas and axis anatomical structure is complex, and close to important features such as spinal cord, vertebral arterys, and screw once sets nail fault, can lead
Cause severe complication.Tan Mingsheng etc. is 84 pieces total by being placed in pedicle screw to 42 atlantoaxial dislocation patients, wherein 4 pieces go out
The phenomenon that existing vertebral artery perforation；Zhang Binglei etc. proposes vertebral plate spiral shell by the measurement to lamina of axis and pedicle of vertebral arch anatomical parameters
Nail is relative to pedicle screw, and vertebral artery injuries possibility is smaller, but its mechanical stability can also be wait inquire into；Chen Qixin etc. passes through
Radiological measurement establishes lateral mass of atlas screw into the safety zone of nail, and this method is suitable for 93% patient, but its safety zone
It is very narrow, it preoperative need to confirm repeatedly, height be required to doctor's technical ability and clinical experience, therefore how to improve atlas and axis pedicle of vertebral arch and set
The safety of nail and accuracy are particularly important.
As 3D printing technique is in the popularization of medical field, realize that personalized precisely operation is current using digitizing technique
The important directions of spinal surgery development, 3D printing navigation template are also gradually applied to cervical operation.Personalization in conventional method
3D printing navigation template the merging of atlas and axis screw can be assisted in art, but have deficiency in actual operation.Because of pedicle of vertebral arch
The merging step of screw includes following closely point into screw to determine, expand etc. multiple steps into nail walking direction and screw way, and initial stage is single to lead
Model plane plate (hereinafter referred to as: initial stage guide plate) can not guide screw to be placed in the implementation of each step, and guide plate guiding is easy to appear in art
Too long placement difficulty is managed, deforms, change screw way difficulty etc. in art, causes to set nail fault.
The anatomical structure of atlas and axis complexity increases the difficulty of pedicle screw merging, how to be safely and accurately placed in vertebra
Pedicle screw is the key that the dislocation of clinical treatment atlas axis fracture.
Summary of the invention
In order to solve the above technical problems, the present invention provides a kind of personalized atlas and axis pedicle screw navigation template step by step
Device, additional screws merging, safety and accuracy are very high, and substantially fault rate is zero.
Solving a kind of personalized atlas and axis pedicle screw of the above technical problem, navigation template device, feature exist step by step
In: including being equipped with screw positioning guide plate, guide plate and tapping guide plate, the pilot hole/pipe size of drilling expand step by step, by set nail sequence by
One additional screws are placed in centrum, and nail is set in completion.
I.e. positioning guide plate pilot hole internal diameter < drilling guide plate guiding bore < tapping guidance guide plate is oriented to bore.
The screw positioning guide plate is equipped with positioning mechanism, entry point location hole and horizontal connection structure, location hole and is located at localization machine
On structure, positioning mechanism is applied on atlas and axis back side, and the vertebral plate and articular process of form centrum corresponding to preoperative simulation operation are complete
Full fitting；Heng Lian mechanism both ends are connected with positioning mechanism respectively, and the positioning mechanism of two sides is linked into an integrated entity.
The drilling guide plate is equipped with positioning mechanism, drilling guide pipe and horizontal connection structure, guide pipe be located on positioning mechanism and
Positioning mechanism is connected as a body, and positioning mechanism is applied on atlas and axis back side, form centrum corresponding to preoperative simulation operation
Vertebral plate and articular process are bonded completely；The guide pipe that drills is interior to be equipped with guiding tube passage, runs through drilling guide pipe and positioning mechanism；It is horizontal
Even mechanism both ends are connected with positioning mechanism respectively, and the positioning mechanism of two sides is linked into an integrated entity.The guide pipe guidance hand vertebra that drills bores
Hole.
The tapping guide plate, which is equipped with, is located at positioning equipped with positioning mechanism, tapping guide pipe and horizontal connection structure, tapping guide pipe
It is connected as a body in mechanism with positioning mechanism, positioning mechanism is applied on atlas and axis back side, form and preoperative simulation operation phase
The vertebral plate and articular process for answering centrum are bonded completely；It is equipped with tapping channel in tapping guide pipe, runs through tapping guide pipe and positioning
Mechanism；Heng Lian mechanism both ends are connected with positioning mechanism respectively, and the positioning mechanism of two sides is linked into an integrated entity.The guidance of tapping guide pipe
Hand vertebra tapping.
The positioning mechanism includes being equipped with vertebral plate positioning mechanism and articular process positioning mechanism, vertebral plate positioning mechanism and articular process
Positioning mechanism links into an integrated entity, and the vertebral plate of centrum corresponding to preoperative simulation operation and articular process are bonded form completely respectively.
Positioning guide plate be responsible for determining screw into fixed point, therefore the not guide pipe of channeling direction.Drilling guidance guide plate and
Tapping guidance guide plate is responsible for the guidance of screw orientation, therefore has guide pipe.
Positioning mechanism is used to position atlas and axis pedicle screw entry point in the present invention, determines the position of Screw entrance point；
Screw guide-localization hole determines screw into nail direction.Positioning mechanism attaches face and contains the important anatomic landmark of atlas and axis, as after
Bend lower separation structure.Atlas does not have a spinous process, and upper point has vertebral artery, comprising separation structure under cantle improve the stability placed in art and
Accuracy.
The Heng Lian mechanism is equipped with footstock, horizontal company and tranverse connecting rod, and footstock connects two sides tranverse connecting rod, tranverse connecting rod one end and footstock
It is connected, the other end is connected with positioning mechanism, and horizontal chord support structure is located at below footstock, and both ends are fixed with two tranverse connecting rods respectively
Connection.
The horizontal connection structure for passing through navigation template device in the present invention, can remove less soft tissue, be convenient for navigation template
Placement, improve accuracy.Footstock and horizontal even support structure are convenient for finger pressing in art to fix and mark the name and section of patient
Section, tranverse connecting rod one end is connected with footstock, and the other end is connected with positioning mechanism, and horizontal vicinal is in footstock lower section, and both ends are respectively with two
Root tranverse connecting rod is fixedly connected.The positioning mechanism of horizontal connection structure connection bilateral, becomes an entirety；And it can be with hand when performing the operation
Finger pressure is held, plays the role of being auxiliarily fixed using its progress, convenient for fixed in art.Footstock facilitates operation and the finger force in art
And finger pressure.The horizontal connection structure of assistant's persistent pressure resting guide is needed in art, guarantees the tight fitting of its attaching face and sclerotin.
The horizontal company and footstock angle > 90 DEG C.The footstock is equipped with home block, to distinguish.
The location hole internal diameter 2.2-2.7mm, drilling guiding bore are 3.2-3.8mm, and tapping hole guiding bore is
3.8-4.2mm；In prioritization scheme, location hole internal diameter 2.5mm, drilling guiding bore is 3.5mm, and tapping hole guiding bore is
4mm。
The drilling guiding pipe outside diameter is 10-14mm, length 8-12mm；Drilling guiding pipe outside diameter is in prioritization scheme
12mm, length 10mm.
The tapping guiding pipe outside diameter is 11-13mm, length 14-16mm；In prioritization scheme, tapping guiding pipe outside diameter is
12mm, length 15mm.
The base thickness is 2.8-3.2mm, is 3mm in prioritization scheme.
Pilot hole, guide pipe internal diameter be according to using internal fixation device Aided design, to enable to operate instrument smoothly
By and obviously do not shake, if the internal diameter designed when using other Products should than its operate instrument it is 0.2mm big.
Screw positioning guide plate, drilling guidance guide plate and tapping guidance guide plate are applied to atlas and axis same area one by one respectively.
Screw duct, it is necessary to first determine entry point, then determine direction, then expand one by one.
By Design and 3D printing " positioning guide plate ", " drilling guide plate " and " tapping guide plate " in the present invention, in art
Every single stepping that above-mentioned template is attached at the auxiliary pedicle screw merging of cervical vertebra rear portion sclerotin by nail sequence is set one by one, step by step
Expand, the clinical effectiveness achieved.
The preparation method of a kind of personalization atlas and axis pedicle screw navigation template device step by step in the present invention, including it is following
Step:
(1) reconstructing three-dimensional model of atlas and axis: the preoperative cervical vertebra CT scanning of patient's row leads the original DICOM data of cervical vertebra CT
Enter Minics19.0 software (Materialise, Belgium)；Choosing the newly-built two-dimentional mask of Bone CT threshold value (can be according to patient bone
Density appropriate adjustment threshold value), atlas and axis is split by " segment " module, extracts atlas and axis two dimension mask, and carry out
Three-dimensional reconstruction obtains the threedimensional model of atlas and axis.
(2) nail is set in simulation: in " MedCAD " module, selecting cylindrical body to represent screw, and simulate in Mimics software
Set nail；Cylinder diameter is set, is placed in along atlas and axis pedicle of vertebral arch direction by rear, and in cross section, coronal-plane, sagittal plane adjustment
Screw position, guarantee cylindrical body are breakthrough cortical bone in above three section.Above-mentioned threedimensional model and cylindrical body are saved as into STL
File.
(3) design of guide plate system step by step: 1. above-mentioned stl file import 11.0 software of 3-matic (Materialise,
Belgium)；2. being spread centered on Screw entrance point to surrounding on atlas and axis surface and carrying out " mark " label, extract atlas and axis
Surface texture, and negative drawing at appropriate thickness obtain the attaching pedestal of guide plate Yu centrum rear；3. according to the entirety of centrum
Form and spinous process structure delineate sketch along spinous process direction, and convert physical model, the i.e. horizontal company of guide plate and support knot for sketch
Structure；4. replicating cylindrical body, and diameter is set, attaches pedestal and subtracts the cylindrical body, just obtains pedestal only comprising location hole, will lead
The horizontal company of plate, support construction merge with pedestal progress boolean is attached, and (no guide pipe) is completed in " positioning guide plate " design；5. 2 duplications
Its diameter is respectively set in cylindrical body, and the cylindrical body of minor diameter is subtracted with pedestal in the cylindrical body of major diameter and " 2. ", is just wrapped
Attaching pedestal containing guide pipe equally merges it with the horizontal company of guide plate, support construction boolean, and " drilling guide plate " design is completed；⑥
The design that repeats the above steps " tapping guide plate ".
(4) 3D printing and post-processing of guide plate system and cervical vertebra model: above-mentioned guide plate saves as stl file, is passed to 3D printing
Mechanism makees and post-processing.
Extraordinary effect is achieved in the present invention:
1. nail is accurate higher: all guide plates are independently attached on sclerotin, and will not occur with the change of position in art cannot
Tight the case where attaching, sets nail accuracy rate and reaches 100%, the accuracy having had.
2. Design accurately can be matched: " positioning guide plate " be not because have guide-tube structure, not by surrounding soft tissue in device
Influence, therefore be easily placed in art, guiding hole site can also be directly observed when determining entry point, avoids determining
It is deviated when entry point because of shearing, entry point offset is only 0.78 ± 0.70mm in this group；" drilling guide plate " is led
Bore is that can just accommodate diameter 2.0mm hand drill in 2.2mm art, and catheter length is shorter, is relatively easy to place, therefore can be compared with
To be closely attached on sclerotin, the accuracy for setting nail direction is improved, YOZ, XOY plane angular deviation relatively compare in this group
Group is small, it was demonstrated that its angular deviation is smaller；" tapping guide plate " has that internal diameter is bigger can accommodate screw tapping, it is ensured that in tapping process
The change in direction, and the fine tuning in direction can be carried out, improve precision.
It is required 3. aging performance meets operation.
Detailed description of the invention
Fig. 1 is plate device structural schematic diagram in the present invention
Fig. 2 is the integrated structure schematic diagram of screw positioning guide plate and centrum in the present invention
Fig. 3 is the integrated structure schematic diagram of drilling guidance guide plate and centrum in the present invention
Fig. 4 is the integrated structure schematic diagram that tapping guides guide plate and centrum in the present invention
Fig. 5 is the integrated structure schematic diagram of plate device of the present invention and centrum
Fig. 6 is the pedicle screw striograph being implanted into art
Wherein, it identifies specifically:
1. location hole, 2. articular process positioning mechanisms, 3. vertebral plate positioning mechanisms, 4. footstocks, 5. horizontal chord support mechanisms, 6. drillings
Guide pipe, 7. guiding tube passages, 8. horizontal companies, 9. tranverse connecting rods, 10. tapping guide pipes, 11. tapping channels, 12. positioning mechanisms, 13.
Screw positioning guide plate, 14. drilling guidance guide plates, 15. tapping guide guide plate, 16. location structures, 17. centrums, 18. tapping guidance
Guide plate guidance hand vertebra determines pedicle of vertebral arch screw nail channel, 19. home blocks
Specific embodiment
Invention is further explained With reference to embodiment:
Embodiment 1
A kind of personalization atlas and axis pedicle screw navigation template device step by step, is equipped with screw positioning guide plate, drill guide plate
With tapping guide plate, pilot hole (pipe) size expands step by step, and by nail sequence is set, additional screws are placed in centrum one by one, and nail is set in completion.I.e.
Positioning guide plate pilot hole internal diameter < drilling guide plate guiding bore < tapping guidance guide plate is oriented to bore.
Screw positioning guide plate is equipped with positioning mechanism, entry point location hole and horizontal connection structure, location hole and is located on positioning mechanism,
Positioning mechanism is applied on atlas and axis back side, and the vertebral plate and articular process of form centrum corresponding to preoperative simulation operation paste completely
It closes；Heng Lian mechanism both ends are connected with positioning mechanism respectively, and the positioning mechanism of two sides is linked into an integrated entity.Positioning guide hole guides spiral shell
Follow closely the determination into nail.
Drilling guide plate is equipped with positioning mechanism, drilling guide pipe and horizontal connection structure, guide pipe and is located on positioning mechanism and positions
Mechanism is connected as a body, and positioning mechanism is applied on atlas and axis back side, the vertebral plate of form centrum corresponding to preoperative simulation operation
It is bonded completely with articular process；The guide pipe that drills is interior to be equipped with guiding tube passage, runs through drilling guide pipe and positioning mechanism；Horizontal even machine
Structure both ends are connected with positioning mechanism respectively, and the positioning mechanism of two sides is linked into an integrated entity.Drill guide pipe guidance hand vertebra drilling, really
Determine screw orientation.
Tapping guide plate, which is equipped with, is located at positioning mechanism equipped with positioning mechanism, tapping guide pipe and horizontal connection structure, tapping guide pipe
Upper and positioning mechanism is connected as a body, and positioning mechanism is applied on atlas and axis back side, form vertebra corresponding to preoperative simulation operation
The vertebral plate and articular process of body are bonded completely；It is equipped with tapping channel in tapping guide pipe, runs through tapping guide pipe and positioning mechanism；
Heng Lian mechanism both ends are connected with positioning mechanism respectively, and the positioning mechanism of two sides is linked into an integrated entity.Tapping guide pipe guides hand vertebra
Tapping expands screw way.
Positioning mechanism includes being equipped with vertebral plate positioning mechanism and articular process positioning mechanism, vertebral plate positioning mechanism and articular process positioning
Mechanism links into an integrated entity, and the vertebral plate of centrum corresponding to preoperative simulation operation and articular process are bonded form completely respectively.
Heng Lian mechanism is equipped with footstock, horizontal company and tranverse connecting rod, and footstock connects two sides tranverse connecting rod, tranverse connecting rod one end and footstock phase
Even, the other end is connected with positioning mechanism, and horizontal chord support structure is located at below footstock, and both ends are fixed with two tranverse connecting rods connect respectively
It connects.
Positioning mechanism is used to position atlas and axis pedicle screw entry point, determines the position of Screw entrance point；Screw guiding
Location hole determines screw into nail direction.Positioning mechanism attaches face and contains the important anatomic landmark of atlas and axis, such as lower point of cantle knot
Structure.Atlas does not have spinous process, and upper point has vertebral artery, improves the stability and accuracy placed in art comprising separation structure under cantle.
Location hole internal diameter 2.5mm, drilling guiding bore are 3.5mm, and it is 4mm that tapping hole, which is oriented to bore,.
Drilling guiding pipe outside diameter is 12mm, length 10mm.It is 12mm, length 15mm that tapping, which is oriented to pipe outside diameter,.Tapping
Its conduit of guide plate is slightly long, keeps channeling direction more acurrate.Base thickness is 3mm.
Pilot hole, guide pipe internal diameter be according to using internal fixation device Aided design, to enable to operate instrument smoothly
By and obviously do not shake, it is proposed that if the internal diameter designed when using other Products should than its operate instrument it is 0.2mm big.
Screw positioning guide plate, drilling guidance guide plate and tapping guidance guide plate are applied to atlas and axis same area one by one respectively.
Screw duct, it is necessary to first determine entry point, then determine direction, then expand one by one.
Preparation method such as following steps:
(1) reconstructing three-dimensional model of atlas and axis: the preoperative cervical vertebra CT scanning of patient's row, surface sweeping parameter are as follows: voltage 120kv,
Electric current 185.25mAs, 512 × 512 pixel of matrix, thickness 0.625mm；The original DICOM data of cervical vertebra CT are imported
Minics19.0 software (Materialise, Belgium)；Choosing the newly-built two-dimentional mask of Bone CT threshold value (can be close according to patient bone
Spend appropriate adjustment threshold value), atlas and axis is split by " segment " module, extracts atlas and axis two dimension mask, and carry out three
Dimension is rebuild, and the threedimensional model of atlas and axis is obtained.
(2) nail is set in simulation: in " MedCAD " module, selecting cylindrical body to represent screw, and simulate in Mimics software
Set nail；Cylinder diameter is set as 3.5mm, is placed in along atlas and axis pedicle of vertebral arch direction by rear, and in cross section, coronal-plane, arrow
Shape face adjusting screw position, guarantee cylindrical body are breakthrough cortical bone in above three section.By above-mentioned threedimensional model and cylinder
Body saves as stl file.
(3) design of guide plate system step by step: 1. above-mentioned stl file import 11.0 software of 3-matic (Materialise,
Belgium)；2. being spread centered on Screw entrance point to surrounding on atlas and axis surface and carrying out " mark " label, extract atlas and axis
Surface texture, and with the thickness negative drawing of 3mm, obtain the attaching pedestal of guide plate Yu centrum rear；3. according to the entirety of centrum
Form and spinous process structure delineate sketch along spinous process direction, and convert physical model, the i.e. horizontal company of guide plate and support knot for sketch
Structure；4. replicating the cylindrical body of 3.5mm, 2.2mm is set by its diameter, pedestal is attached and subtracts the cylindrical body, just only included
The pedestal of location hole merges the horizontal company of guide plate, support construction with pedestal progress boolean is attached, and (nothing is completed in " positioning guide plate " design
Guide pipe)；5. its diameter is respectively set to 6mm and 2.2mm by 2 duplication cylindrical bodies, with 6mm cylindrical body and
" 2. " pedestal subtracts 2.2mm cylindrical body in, just obtains the attaching pedestal comprising guide pipe, equally by itself and guide plate cross
Even, support construction boolean merges, and " drilling guide plate " (guiding bore 2.2mm, be oriented to pipe range 10mm) design is completed；6. repeating
State step design " tapping guide plate " (guiding bore 3.5mm, be oriented to pipe range 15mm).
(4) 3D printing and post-processing of guide plate system and cervical vertebra model: above-mentioned guide plate saves as stl file, is passed to 3D printing
Machine carries out printing and post-processing in kind.
Embodiment 2
In other contents such as embodiment 1, wherein
Horizontal company and footstock angle > 90 DEG C, horizontal even height > patient spinous process height.Footstock is equipped with home block, to distinguish.
Location hole internal diameter 2.2 or 2.7mm, drilling guiding bore are 3.2 or 3.8mm, and it is 3.8 that tapping hole, which is oriented to bore,
Or 4.2mm.Drilling guiding pipe outside diameter is 10 or 14mm, and length is 8 or 12mm.
It is 11 or 13mm that tapping, which is oriented to pipe outside diameter, and length is 14 or 16mm.Base thickness is 2.8 or 3.2mm.
Test one
If test group and control group, in which:
Test group: being placed in vertebral plate and spinous process rear portion for above-mentioned guide plate one by one, observes guide plate and whether model combines closely；
Entry point is determined by " positioning guide plate "；Diameter 2.0mm Kirschner wire is pierced by " drilling guide plate "；It is carried out by " tapping guide plate "
Screw way tapping.Visually observe in above-mentioned steps, if having a breakthrough of cortical bone, preoperative verifying navigation template system step by step it is accurate
Degree.
Control group: it is preoperative that only initial stage guide plate is attached and simulates operation on model, observe screw way situation.Preoperative navigation template
And model sterilized by plasma low-temperature it is spare.
Test to picture: 33 atlas axis fractures, dislocation patient, follow up time 12~40 months.Test group: application is led step by step
Plate assists atlas and axis pedicle screw fixation operation 19, male 11, female 8；It is age 29~64 years old, 37.53 years old average；Dentata tooth
The prominent fracture 7 of shape, odontoid fracture are dislocated 6 with dislocation 6, fracture of atlas.Control group: atlas and axis is assisted using initial stage guide plate
Pedicle screw fixation operation 14, male 8, female 6；It is age 23~54 years old, 39.21 years old average；Fracture of odontoid process of vertebra dentata 6,
Odontoid fracture is dislocated 3 with dislocation 5, fracture of atlas.Two groups of Genders, age, damage segment and type etc. generally provide
Expect that comparing difference is not statistically significant (P > 0.05), is comparable.
Operation method
All operations are completed by same operator doctor, are inside fixed as Beijing prestige Francis Koo development corporation, Ltd. product.Patient
General anesthesia, dorsal position, dislocation patient's skull traction maintain reset state.
Test group: neck upper back hits exactly approach, appears atlas and axis rear portion bony structure, attaches pedestal according to guide plate step by step and exists
The muscle and ligament of attachment are carefully removed in position and size on sclerotin.It disposes " positioning guide plate " first: its pedestal is attached into extensive region
Lamina of axis, spinous process rear, observe its compactness, and assistant presses horizontal-associate structure above guide plate and maintains the tight of guide plate and sclerotin
Fitting, patient's High speed drill or Kirschner wire (diameter is 2.0mm) determine entry point position by the pilot hole on pedestal；So
Replacement " drilling guide plate " afterwards, reaffirms that maintenance is bonded with the tight of sclerotin, is determined by its guide pipe into nail side using hand drill
To, and deepen screw way one by one to increase 2mm every time, detecting screw way using probe before deepening each time, whether there is or not break through cortical bone；
" tapping guide plate " finally is replaced, replacement screw screw tap expands screw way under the guidance of its guide pipe.After probe's confirmation is broken through without cortex
It is placed in diameter 3.5mm Universal pedicle screw, after the completion of setting nail, " C " arm X-ray machine perspective screw position is satisfied and dislocation is entangled
Just.Atlas and axis is carried out using the good pitman of pre-bending to fix.Irrigate suture, and art finishes.
Control group: the same test group of operative approach, it is identical to set nail mode, underlying nail is assisted in guide plate.
Post surgery treatment
Postoperative patient bed, braking are axial to turn over.Prophylactic postoperative application antibiotic 1~2 time, postoperative 2d, observation wound
How much mouth drainage flow, pull out drainage tube depending on drainage flow.Have the postoperative routine application hormone of the patient of neurotrosis and dehydrating agent 3~
5d.Postoperative 3d brace protects out-of-bed activity.Postoperative all patient's conventional line X-ray films and CT examination.Neck brace or brace fix 3
Month.
Evaluation index
1. Safe screw: evaluating the relative position of postoperative CT screw and pedicle of vertebral arch with the methods of Kawaguchi.0 grade: spiral shell
Nail is entirely located in pedicle of vertebral arch；I grade: screw is pierced by pedicle wall < 2mm, does not occur complication；II grade: screw is pierced by pedicle of vertebral arch
Wall >=2mm, does not occur complication；III grade: the severe complications such as vertebral artery, nerve root injury occur.
2. Screw entrance point accuracy: the original DCIOM formatted data of the postoperative CT of patient is imported in Mimics software, it is three-dimensional
Rebuild atlas and axis threedimensional model and pedicle screw.Preoperative simulation is placed in cylindrical body by " image registration "
Project file also imports together, and carries out image registration with postoperative project file.After registration, after surveying in screw and cylindrical body
Distance of the heart when entering cortex bone, as postoperative Screw entrance point deviation.
3. screw angle accuracy: being in a manner described registrated the atlas and axis threedimensional model for performing the operation forward and backward.It is measured after registration
The angle difference of postoperative screw and simulation merging center in three-dimensional system of coordinate on X, Y, Z axis direction, as postoperative spiral shell
Follow closely the deviation of directivity.Calculation is as follows: all coordinate values are based on world coordinate system, x1,y1,z1It is the three-dimensional that screw way enters pin mark
Coordinate, x2,y2,z2Screw way is the three-dimensional coordinate of pin mark out；Screw way ZOY plane angular deviation calculation formula, XOY plane,
The angle calculation formula of YOZ plane is similarly:
Statistical analysis
Applied statistics software SPSS19.0 is analyzed.All measurement data means standard deviationsIt indicates, between group
Measurement data compares to be examined using independent sample double sample t.Enumeration data indicates that enumeration data compares using card side between group with rate
It examines；All inspection levels of signifiance are that 95%, P < 0.05 thinks there is statistical difference.
Test result
The design of test group guide plate and print time amount to 7~9h, and control group is 6~8h, and 33 patients design simultaneously altogether
Printing 142, guide plate is implanted into 132 pieces of pedicle screw altogether, and all patients smoothly complete operation, such as Fig. 6.
Two groups of Gender (χ2=0.002, p=1), the age (T=-0.63, p=0.53), damage segment (χ2=0.42,
P=0.81 difference) is not statistically significant (table 1), and two groups are comparable.This group of patient obtains follow-up, follow up time
> December；No important blood vessels damage and neurotrosis aggravate case.Operating time is respectively 100.62 ± 12.27min, 112.76
± 19.93min, intraoperative blood loss are respectively 183.76 ± 53.90ml, 247.48 ± 80.88ml, and two groups of comparing differences have statistics
Learn meaning.(P < 0.05, table 1)
Postoperative X line and CT show that dislocation is corrected.76 screw of test group is fully located in pedicle of vertebral arch cortex (0 grade), sets
Following closely safety is 100%；Control group 52 do not make a decision object for appreciation go be located at vertebral arch root skin within (0 grade), set nail safety be 91.07% liang
Group statistically significant (p=0.03, table 1).The postoperative Screw entrance point offset of test group and XOY, YOZ, XOZ planar offset angle
Degree is respectively 0.78 ± 0.70mm, 1.38 ± 1.41 °, 1.01 ± 0.45 °, 0.75 ± 1.23 °；And control group These parameters are distinguished
For 1.47 ± 1.48mm, 2.10 ± 1.25 °, 0.91 ± 0.63 °, 1.48 ± 0.49 °, entry point offset, YOZ plane, XOY are flat
Angular deviation two groups of comparing differences in face are statistically significant, entry point offset, X-axis, two groups of X-axis angular deviation it is poor
Different statistically significant (table 3).Show that guide plate has relative to initial stage guide plate step by step and preferably set nail safety, and more can be accurate
With Design screw way.
1 two groups of patients of table are preoperative, general information compares in art
Note: a gender is described by male/female；B damages segment by fracture of odontoid process of vertebra dentata/odontoid fracture with dislocation/lepospondylous bone
Folding dislocation description；Gender and damage segment use Chi-square Test, and age, operating time and amount of bleeding use independent sample double sample
T examines (test group-control group)；Operating time, two groups of amount of bleeding compare, difference is statistically significant (P < 0.05).
2 atlas and axis of table is set nail safety and is compared
In 3 test group of table, preoperative, postoperative atlas and axis Screw entrance point and angular deviation are compared
Note: test group-control group is taken in independent sample double sample t inspection
As can be seen from the above expansion type 3D printing navigation template system assists atlas and axis pedicle of vertebral arch screw step by step in the present invention
The dislocation of internal fixation treatment atlas axis fracture is followed closely, operating time and intraoperative hemorrhage can be lacked relative to initial stage single navigation template, is improved
Nail safety is set, Design more can be more accurately matched, there is certain clinical generalization value.Meet determining entry point simultaneously, refer to
The operation such as nail direction and auxiliary tapping is introduced, " the navigation template system step by step " of more guide plates can be further improved accuracy.
Basic principles and main features and advantages of the present invention of the invention, above-described embodiment has been shown and described above
It is merely illustrated the principles of the invention with described in specification, without departing from the spirit and scope of the present invention, the present invention
It will also have various changes and improvements, these changes and improvements are fallen in scope of the claimed invention.The present invention claims
The range of protection is defined by the appending claims and its equivalent thereof.
Claims (9)
1. a kind of personalization atlas and axis pedicle screw navigation template device step by step, it is characterised in that: including screw positioning guide plate,
Drilling guidance guide plate and tapping guide guide plate, and volume size expands step by step, and by nail sequence is set, additional screws are placed in centrum one by one, complete
It is followed closely at setting.
2. navigation template device, feature exist a kind of personalized atlas and axis pedicle screw according to claim 1 step by step
In: the screw positioning guide plate is equipped with positioning mechanism, entry point location hole and horizontal connection structure, location hole and is located on positioning mechanism,
Positioning mechanism is applied on atlas and axis back side, and the vertebral plate and articular process of form centrum corresponding to preoperative simulation operation paste completely
It closes；Heng Lian mechanism both ends are connected with positioning mechanism respectively, and the positioning mechanism of two sides is linked into an integrated entity.
3. navigation template device, feature exist a kind of personalized atlas and axis pedicle screw according to claim 1 step by step
In: the drilling guide plate is equipped with positioning mechanism, drilling guide pipe and horizontal connection structure, and drilling guide pipe is located on positioning mechanism and determines
Position mechanism is connected as a body, and positioning mechanism is applied on atlas and axis back side, the vertebra of form centrum corresponding to preoperative simulation operation
Plate and articular process are bonded completely；The guide pipe that drills is interior to be equipped with guiding tube passage, runs through drilling guide pipe and positioning mechanism；Horizontal company
Mechanism both ends are connected with positioning mechanism respectively, and the positioning mechanism of two sides is linked into an integrated entity.
4. navigation template device, feature exist a kind of personalized atlas and axis pedicle screw according to claim 1 step by step
In: the tapping guide plate is equipped with to be located on positioning mechanism equipped with positioning mechanism, tapping guide pipe and horizontal connection structure, tapping guide pipe
It is connected as a body with positioning mechanism, positioning mechanism is applied on atlas and axis back side, form centrum corresponding to preoperative simulation operation
Vertebral plate and articular process be bonded completely；It is equipped with tapping channel in tapping guide pipe, runs through tapping guide pipe and positioning mechanism；It is horizontal
Even mechanism both ends are connected with positioning mechanism respectively, and the positioning mechanism of two sides is linked into an integrated entity.
5. navigation template fills a kind of personalization atlas and axis pedicle screw according to any one of claim 2-4 step by step
Set, it is characterised in that: the positioning mechanism include be equipped with vertebral plate positioning mechanism and articular process positioning mechanism, vertebral plate positioning mechanism and
Articular process positioning mechanism links into an integrated entity, and form respectively paste completely by the vertebral plate of centrum corresponding to preoperative simulation operation and articular process
It closes.
6. navigation template fills a kind of personalization atlas and axis pedicle screw according to any one of claim 2-4 step by step
It sets, it is characterised in that: the Heng Lian mechanism is equipped with footstock, horizontal company and tranverse connecting rod, and footstock connects two sides tranverse connecting rod, tranverse connecting rod one end
Be connected with footstock, the other end is connected with positioning mechanism, and horizontal chord support structure is located at below footstock, and both ends respectively with two horizontal companies
Bar is fixedly connected.
7. navigation template device, feature exist a kind of personalized atlas and axis pedicle screw according to claim 1 step by step
In: the location hole internal diameter 2.2-2.7mm, drilling guiding bore are 3.2-3.8mm, and it is 3.8- that tapping hole, which is oriented to bore,
4.2mm；In prioritization scheme, location hole internal diameter 2.5mm, drilling guiding bore is 3.5mm, and it is 4mm that tapping hole, which is oriented to bore,.
8. navigation template device, feature exist a kind of personalized atlas and axis pedicle screw according to claim 1 step by step
In: the drilling guiding pipe outside diameter is 10-14mm, length 8-12mm；Drilling guiding pipe outside diameter is 12mm in prioritization scheme, long
Degree is 10mm；The tapping guiding pipe outside diameter is 11-13mm, length 14-16mm；In prioritization scheme, tapping is oriented to pipe outside diameter
For 12mm, length 15mm.
9. a kind of preparation side of personalized atlas and axis pedicle screw according to claim 1 navigation template device step by step
Method, it is characterised in that: the following steps are included:
(1) reconstructing three-dimensional model of atlas and axis: the preoperative cervical vertebra CT scanning of patient's row imports the original DICOM data of cervical vertebra CT
Minics19.0 software is chosen the newly-built two-dimentional mask of Bone CT threshold value, is split by " segment " module to atlas and axis,
Atlas and axis two dimension mask is extracted, and carries out three-dimensional reconstruction, obtains the threedimensional model of atlas and axis；
(2) nail is set in simulation: in " MedCAD " module, cylindrical body being selected to represent screw, and nail is set in simulation in Mimics software；
Cylinder diameter is set, is placed in along atlas and axis pedicle of vertebral arch direction by rear, and in cross section, coronal-plane, sagittal plane adjusting screw
Position, guarantee cylindrical body are breakthrough cortical bone in above three section；Above-mentioned threedimensional model and cylindrical body are saved as into STL text
Part；
(3) design of guide plate system step by step: 1. above-mentioned stl file imports 11.0 software of 3-matic；2. on atlas and axis surface, with
It is spread centered on Screw entrance point to surrounding and carries out " mark " label, extract atlas and axis surface texture, and is anti-at appropriate thickness
To stretching, the attaching pedestal of guide plate Yu centrum rear is obtained；3. according to the configuration of centrum and spinous process structure, along spinous process direction
Sketch is delineated, and converts physical model, the i.e. horizontal company of guide plate and support construction for sketch；4. replicating cylindrical body, and diameter is set,
Attach pedestal subtract the cylindrical body, just obtain only include location hole pedestal, by the horizontal company of guide plate, support construction and attach pedestal into
Row boolean merges, and completes positioning guide plate design；5. 2 duplication cylindrical bodies, are respectively set its diameter, with the cylindrical body of major diameter and
" 2. " pedestal subtracts the cylindrical body of minor diameter in, just obtains the attaching pedestal comprising guide pipe, equally by itself and the horizontal company of guide plate, branch
Support structure boolean merges, and " drilling guide plate " design is completed；6. the design that repeats the above steps " tapping guide plate "；
(4) 3D printing and post-processing of guide plate system and cervical vertebra model: above-mentioned guide plate saves as stl file, be passed to 3D printer into
Row printing and post-processing.
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