CN103860295A - Digital design and manufacturing method for knee joint tibia prosthesis - Google Patents
Digital design and manufacturing method for knee joint tibia prosthesis Download PDFInfo
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- CN103860295A CN103860295A CN201410082871.2A CN201410082871A CN103860295A CN 103860295 A CN103860295 A CN 103860295A CN 201410082871 A CN201410082871 A CN 201410082871A CN 103860295 A CN103860295 A CN 103860295A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/38—Joints for elbows or knees
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
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- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
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Abstract
The invention relates to a digital design and manufacturing method for a knee joint tibia prosthesis. The method comprises the steps of (1) establishing a knee joint tibia three-dimensional digital model according to medical image data based on the knee joint tibia of healthy people; (2), performing digital simulation of tibia rear end osteotomy according to a knee joint arthroplasty surgery scheme and measuring the design-related geometric parameter of the tibia prosthesis; (3), obtaining the geometric shape parameters of the tibia prosthesises of different genders and models according to the statistical analysis, and drawing the tibia prosthesis design model; (4) manufacturing the knee joint tibia prosthesis according to the tibia prosthesis design model through a 3D (three-dimensional) printing technology. According to the digital design and manufacturing method for the knee joint tibia prosthesis, the tibia prosthesises of different genders and models can be obtained, the prosthesises can be matched with the anatomic form features of different knee joint tibia skeletons of male and female in China, and the coverage rate between the prosthesises and the osteotomy section of the knee joint tibia and the good rate of surgeries are improved.
Description
Technical field
The present invention relates to a kind of design and manufacture method of artificial knee joint prosthesis, Design of digital and the manufacture method of the knee joint tibial prosthesis using in a kind of whole knee artificial joint replacement operation of specific design.
Background technology
Knee osteoarthritis (knee osteoarthritis, KOA) is a kind of degeneration taking articular cartilage, destruction and the hyperosteogeny chronic joint disease as feature, has become one of modal reason of the chronic disability of middle-aged and elderly people.Total knee replacement is a kind of bone surgery very ripe, that extensively should carry out, has become the arthropathic effective ways for the treatment of kneecap in late period, can alleviate patient's slight illness, improves the quality of living.
Studies show that not agnate crowd, the kneed anatomic form of same ethnic masculinity and femininity all have certain difference.The knee joint tibial prosthesis overwhelming majority using in China market is at present from American-European manufacturer or domesticly imitate American-European manufacturer, these prostheses are taking American-European crowd's knee-joint anatomy form as basic engineering, poor with Aisan knee-joint anatomy form matching.In addition, these tibial prosthesis are not considered male and women's Tibia Anatomy morphological differences yet, the tibial prosthesis that masculinity and femininity application of shape is identical, thereby cause tibial prosthesis not mate with tibia form, cause prosthese cover incomplete or hang, and then the wearing and tearing, service life that cause prosthese shorten and joint replacement patella pain, swelling etc., the possibility that even causes prosthese to overhaul.Therefore be necessary the sex difference tibial prosthesis that design is mated with knee joint tibia form, improve surgical effect, reduce complication.
3D printing technique becomes one of manufacturing Important Techmical Progress in recent years, and successful Application at medical domain.Laser selective melting technical spirit is for increasing material manufacture, piling up molding, by the model data obtaining by Medical Image Processing and reverse Engineering Technology, melt layer by layer and pile up finished parts product with medical powder material, change traditional standardized, die casting, machined manufacture, started out a kind of novel medical science and manufacture field.
Summary of the invention
For the problems referred to above, the object of this invention is to provide a kind of Design of digital and manufacture method that is applicable to treat the knee joint tibial prosthesis using in the arthropathic total knee replacement of kneecap in late period.
For achieving the above object, the present invention takes following technical scheme: a kind of Design of digital of knee joint tibial prosthesis and manufacture method, it is characterized in that, and comprising:
1) medical image data based on Healthy People knee joint tibia is set up the step of knee joint tibia three-dimensional digitalization model;
2) carry out digital simulation proximal tibia osteotomy according to replacement knee in arthroplasty scheme, and measure the step of tibial prosthesis design interrelated geometrical parameters;
3) obtain the geometric shape parameters of the tibial prosthesis of different sexes, different model by statistical analysis, and draw the step that tibial prosthesis designs a model;
4) design a model according to tibial prosthesis and manufacture the step of knee joint tibial prosthesis by 3D printing technique.
Described step 1) is specially: the CT/MRI tomoscan image of the DICOM form based on Health China human knee joint tibia, use medical image software Mimics, the feature that shows different gray scales according to soft tissue from skeleton in image carries out that image is cut apart, after repairing treatment, carry out three-dimensionalreconstruction to obtain knee joint tibia three-dimensional digitalization model, and be output as PLY formatted file.
Described step 2) be specially: the PLY file of knee joint tibia three-dimensional digitalization model is imported to Geomagic Studio software, the mechanical axis of model tibia, then taking tibia mechanical axis as Z axis, surgery epicondyle line is X-axis, sets up three-dimensional system of coordinate according to right-handed Cartesian coordinate system rule; Complete behind the location of tibia, carry out digital simulation proximal tibia osteotomy according to the operation plan of total knee replacement; After completing, simulation osteotomy carries out the collection of tibial prosthesis design interrelated geometrical parameters.
Tibial prosthesis design interrelated geometrical parameters comprises tibial plateau internal-and external diameter, platform middle part anteroposterior diameter, inner side platform anteroposterior diameter and outside platform anteroposterior diameter.
Described step 3) is specially: utilize statistics software SPSS to carry out statistical analysis to the interrelated geometrical parameters utilization gathering, the geometric shape parameters that obtains different sexes, different model knee joint tibial prosthesis, utilizes three-dimensional mapping software to draw tibial prosthesis and designs a model.
Described step 4) comprises the following steps: 1. tibial prosthesis is designed a model to import in rapid shaping assistant software MaterialiseMagics and process, comprise and put location, interpolation support and layering, and the hierarchical file obtaining is saved as to STL form; 2. hierarchical file is imported to the setting of carrying out scan mode selection and sweep span in RPPath software, obtain importing to rapid prototyping system after two-dimension data, pass into noble gas, the 3D that carries out laser selective melting prints and manufactures; 3. take out the tibial prosthesis test specimen that 3D prints, implement the operation of subsequent heat treatment, sandblast and polishing, complete the manufacture of knee joint tibial prosthesis finished product.
Described step 2. in, the 3D of laser selective melting prints to manufacture and is specially: flexible Pu Fen mechanism is entirely laid on powder on substrate, then laser scans according to the two-dimension data after model layering under computer control, after powder smelting, condense on lower one deck matrix, then moulding cylinder decline powder cylinder rises, the powder feeding again of paving powder system, paving powder, melting powder, repeat this process, until manufactured.
In a preferred embodiment, it is orthogonal scanning that 3D prints the scan mode of manufacturing, and sweep span is set to 0.08mm, processing bed thickness 0.035mm, scanning speed 700mm/s, laser power 160W.
In a preferred embodiment, noble gas is nitrogen or argon, and powder is that 316L rustless steel and cochrome powder mix.
The present invention is owing to taking above technical scheme, it has the following advantages: the medical image data that 1, the present invention is based on Health China human knee joint tibia is set up knee joint tibia three-dimensional digitalization model, obtain the tibial prosthesis of different sexes, different model by digital simulation proximal tibia osteotomy and statistical analysis, this prosthese can mate the different knee joint tibia skeleton anatomic form feature of compatriots' masculinity and femininity, improves prosthese and the coverage rate of knee joint Tibial osteotomy face and the acceptance rate of operation.2, the present invention adopts 3D printing technique to manufacture knee joint tibial prosthesis, break standardization formulation, turned over the unfavorable factors such as the precision that the technique such as die cast, mechanical process has is not high, the process-cycle is grown, involve great expense, start out a kind of novel medical science and manufacture field, not only be applicable to processed complex constitutional detail, and the process-cycle is short, individual character fit is high, and the personalization that is applicable to very much small lot is customized, and also demonstrating personalization becomes the feasibility of following artificial prosthesis developing direction.
Brief description of the drawings
Below in conjunction with accompanying drawing, the present invention is carried out to detailed describing.But only the providing in order to understand better the present invention of accompanying drawing is provided, they not should be understood to limitation of the present invention.
Fig. 1 is schematic flow sheet of the present invention;
Fig. 2 is male's tibial prosthesis of the present invention schematic diagram that designs a model;
Fig. 3 is women's tibial prosthesis of the present invention schematic diagram that designs a model;
Fig. 4 is the tibial prosthesis of the present invention front schematic view that designs a model;
Fig. 5 is the tibial prosthesis of the present invention side schematic view that designs a model.
Detailed description of the invention
Below in conjunction with drawings and Examples, the present invention is described in detail.
As shown in Figure 1, the Design of digital of knee joint tibial prosthesis provided by the invention and manufacture method, comprise the following steps:
1, the CT/MRI tomoscan image of the DICOM form based on Health China human knee joint tibia, use medical image software Mimics, the feature that shows different gray scales according to soft tissue from skeleton in image carries out that image is cut apart, after repairing treatment, carry out three-dimensionalreconstruction to obtain knee joint tibia three-dimensional digitalization model, and be output as PLY formatted file.
2, the PLY formatted file of knee joint tibia three-dimensional digitalization model is imported to Geomagic Studio software, the mechanical axis of model tibia, then taking tibia mechanical axis as Z axis, surgery epicondyle line is X-axis, sets up three-dimensional system of coordinate according to right-handed Cartesian coordinate system rule; Complete behind the three-dimensional coordinate location of tibia, carry out digital simulation proximal tibia osteotomy according to the operation plan of total knee replacement; After simulation osteotomy completes, carry out the collection of tibial prosthesis design interrelated geometrical parameters, comprise tibial plateau internal-and external diameter, tibia middle deck anteroposterior diameter, medial tibial plateau anteroposterior diameter and Lateral tibial plateau anteroposterior diameter.
3, the interrelated geometrical parameters gathering is utilized to statistics software SPSS(Statistical Product and Service Solutions, statistical product and service solution) carry out statistical analysis, obtain the geometric shape parameters of different sexes, different model knee joint tibial prosthesis, utilize three-dimensional mapping software to draw tibial prosthesis and design a model (as shown in Figure 2-5).
4, design a model according to tibial prosthesis and manufacture knee joint tibial prosthesis by 3D printing technique, it specifically comprises the following steps:
1) tibial prosthesis is designed a model import in rapid shaping assistant software MaterialiseMagics and process, comprise and put location, add support and layering, and the hierarchical file obtaining is saved as to STL form.
2) hierarchical file is imported to the setting of carrying out scan mode selection and sweep span in RPPath software, obtain importing to rapid prototyping system Dimel-100 after two-dimension data, pass into noble gas, the 3D that carries out laser selective melting prints and manufactures to complete the tibial prosthesis test specimen that is applicable to different sexes difference.
Wherein, the 3D of laser selective melting prints to manufacture and is specially: flexible Pu Fen mechanism is entirely laid on powder on substrate, then laser scans according to the two-dimension data after model layering under computer control, after powder smelting, condense on lower one deck matrix, then moulding cylinder decline powder cylinder rises, the powder feeding again of Pu Fen mechanism, paving powder, melting powder, repeat this process, until manufactured.Above-mentioned flexible Pu Fen mechanism, moulding cylinder and powder cylinder all belong to the parts in rapid prototyping system Dimel-100, therefore repeat no more.
In a preferred embodiment, it is orthogonal scanning that 3D prints the scan mode of manufacturing, and sweep span is set to 0.08mm, processing bed thickness 0.035mm, scanning speed 700mm/s, laser power 160W.Need to illustrate, above-mentioned technological parameter is not fixing requirement, can change and correspondingly adjust according to rapid shaping processing environment.
In a preferred embodiment, noble gas is nitrogen or argon, and powder is that 316L rustless steel and cochrome powder mix.
3) take out the tibial prosthesis test specimen that 3D prints, implement the operations such as subsequent heat treatment, sandblast and polishing, complete the manufacture of knee joint tibial prosthesis finished product.
The various embodiments described above are only for further describing object of the present invention, technical scheme and beneficial effect; be not limited to the present invention; within the spirit and principles in the present invention all; any amendment of making, be equal to replacement, improvement etc., within protection scope of the present invention all should be included in.
Claims (9)
1. the Design of digital of knee joint tibial prosthesis and a manufacture method, is characterized in that, comprising:
1) medical image data based on Healthy People knee joint tibia is set up the step of knee joint tibia three-dimensional digitalization model;
2) carry out digital simulation proximal tibia osteotomy according to replacement knee in arthroplasty scheme, and measure the step of tibial prosthesis design interrelated geometrical parameters;
3) obtain the geometric shape parameters of the tibial prosthesis of different sexes, different model by statistical analysis, and draw the step that tibial prosthesis designs a model;
4) design a model according to tibial prosthesis and manufacture the step of knee joint tibial prosthesis by 3D printing technique.
2. the Design of digital of a kind of knee joint tibial prosthesis as claimed in claim 1 and manufacture method, it is characterized in that, described step 1) is specially: the CT/MRI tomoscan image of the DICOM form based on Health China human knee joint tibia, use medical image software Mimics, the feature that shows different gray scales according to soft tissue from skeleton in image carries out that image is cut apart, after repairing treatment, carry out three-dimensionalreconstruction to obtain knee joint tibia three-dimensional digitalization model, and be output as PLY formatted file.
3. the Design of digital of a kind of knee joint tibial prosthesis as claimed in claim 2 and manufacture method, it is characterized in that, described step 2) be specially: the PLY file of knee joint tibia three-dimensional digitalization model is imported to Geomagic Studio software, the mechanical axis of model tibia, then taking tibia mechanical axis as Z axis, surgery epicondyle line is X-axis, sets up three-dimensional system of coordinate according to right-handed Cartesian coordinate system rule; Complete behind the three-dimensional coordinate location of tibia, carry out digital simulation proximal tibia osteotomy according to the operation plan of total knee replacement; After completing, simulation osteotomy carries out the collection of tibial prosthesis design interrelated geometrical parameters.
4. the Design of digital of a kind of knee joint tibial prosthesis as claimed in claim 3 and manufacture method, it is characterized in that, tibial prosthesis design interrelated geometrical parameters comprises tibial plateau internal-and external diameter, platform middle part anteroposterior diameter, inner side platform anteroposterior diameter and outside platform anteroposterior diameter.
5. the Design of digital of a kind of knee joint tibial prosthesis as claimed in claim 3 and manufacture method, it is characterized in that, described step 3) is specially: utilize statistics software SPSS to carry out statistical analysis to the interrelated geometrical parameters utilization gathering, the geometric shape parameters that obtains different sexes, different model knee joint tibial prosthesis, utilizes three-dimensional mapping software to draw tibial prosthesis and designs a model.
6. the Design of digital of a kind of knee joint tibial prosthesis as claimed in claim 5 and manufacture method, is characterized in that, described step 4) comprises the following steps:
1. tibial prosthesis is designed a model to import in rapid shaping assistant software MaterialiseMagics and process, comprise and put location, interpolation support and layering, and the hierarchical file obtaining is saved as to STL form;
2. hierarchical file is imported to the setting of carrying out scan mode selection and sweep span in RPPath software, obtain importing to rapid prototyping system after two-dimension data, pass into noble gas, the 3D that carries out laser selective melting prints and manufactures;
3. take out the tibial prosthesis test specimen that 3D prints, implement the operation of subsequent heat treatment, sandblast and polishing, complete the manufacture of knee joint tibial prosthesis finished product.
7. the Design of digital of a kind of knee joint tibial prosthesis as claimed in claim 6 and manufacture method, it is characterized in that, described step 2. in, the 3D of laser selective melting prints to manufacture and is specially: flexible Pu Fen mechanism is entirely laid on powder on substrate, then laser scans according to the two-dimension data after model layering under computer control, after powder smelting, condense on lower one deck matrix, then moulding cylinder decline powder cylinder rises, the powder feeding again of paving powder system, paving powder, melting powder, repeat this process, until manufactured.
8. the Design of digital of a kind of knee joint tibial prosthesis as claimed in claim 7 and manufacture method, is characterized in that, it is orthogonal scanning that 3D prints the scan mode of manufacturing, sweep span is set to 0.08mm, processing bed thickness 0.035mm, scanning speed 700mm/s, laser power 160W.
9. a kind of Design of digital of knee joint tibial prosthesis and manufacture method as claimed in claim 7 or 8, is characterized in that, noble gas is nitrogen or argon, and powder is that 316L rustless steel and cochrome powder mix.
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| CN201410082871.2A CN103860295A (en) | 2014-03-07 | 2014-03-07 | Digital design and manufacturing method for knee joint tibia prosthesis |
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Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104498940A (en) * | 2014-12-03 | 2015-04-08 | 中国航空工业集团公司北京航空材料研究院 | Method of manufacturing titanium-alloy artificial joints by virtue of laser material increase |
| TWI514316B (en) * | 2014-10-09 | 2015-12-21 | Xyzprinting Inc | Method for arranging joints to 3D model, arranging apparatus for the method, and application program for using the same |
| CN106127856A (en) * | 2016-06-27 | 2016-11-16 | 长安大学 | The method containing crack column strata model based on CT scan and 3D printing and making |
| CN107174378A (en) * | 2017-05-19 | 2017-09-19 | 华南理工大学 | One kind rotation clamping type Total knee arthroplasty tibia support and tibial insert assembling structure and implementation method |
| CN107397589A (en) * | 2017-06-28 | 2017-11-28 | 芜湖启泽信息技术有限公司 | A kind of 3D printing navigation template and its manufacture method for aiding in shin bone prosthesis |
| CN107397583A (en) * | 2017-06-28 | 2017-11-28 | 芜湖启泽信息技术有限公司 | A kind of medical shin bone fixing device of 3D printing and preparation method thereof |
| CN107684479A (en) * | 2016-08-04 | 2018-02-13 | 山东威高骨科材料股份有限公司 | For manufacturing the method for knee prosthesis implant and implant for knee prosthesis |
| CN108926411A (en) * | 2018-07-25 | 2018-12-04 | 嘉思特华剑医疗器材(天津)有限公司 | Fixed platform type separate room knee-joint prosthesis and tibial plateau prosthetic designs method |
| CN109549763A (en) * | 2019-01-09 | 2019-04-02 | 上海交通大学医学院附属第九人民医院 | A kind of distal femur list condyle of 3D printing personalization rebuilds prosthese and preparation method thereof |
| CN111685917A (en) * | 2019-03-15 | 2020-09-22 | 北京纳通科技集团有限公司 | Method for matching tibial prosthesis and tibia and processor |
| CN112113836A (en) * | 2020-03-02 | 2020-12-22 | 四川大学 | Intra-articular pressure and bone non-contact strain measurement system based on 3D printing |
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| CN103584932A (en) * | 2013-10-23 | 2014-02-19 | 华南理工大学 | Designing method and manufacturing method of knee joint femoral prosthesis used for total knee arthroplasty |
| CN103584930A (en) * | 2013-10-23 | 2014-02-19 | 华南理工大学 | Reverse design and production method of individual total knee prosthetic implant |
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| CN103584931A (en) * | 2013-10-23 | 2014-02-19 | 华南理工大学 | Bionic gradient knee femoral prosthesis structure and a production method thereof |
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Cited By (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI514316B (en) * | 2014-10-09 | 2015-12-21 | Xyzprinting Inc | Method for arranging joints to 3D model, arranging apparatus for the method, and application program for using the same |
| CN104498940A (en) * | 2014-12-03 | 2015-04-08 | 中国航空工业集团公司北京航空材料研究院 | Method of manufacturing titanium-alloy artificial joints by virtue of laser material increase |
| CN106127856A (en) * | 2016-06-27 | 2016-11-16 | 长安大学 | The method containing crack column strata model based on CT scan and 3D printing and making |
| CN107684479A (en) * | 2016-08-04 | 2018-02-13 | 山东威高骨科材料股份有限公司 | For manufacturing the method for knee prosthesis implant and implant for knee prosthesis |
| CN107174378A (en) * | 2017-05-19 | 2017-09-19 | 华南理工大学 | One kind rotation clamping type Total knee arthroplasty tibia support and tibial insert assembling structure and implementation method |
| CN107174378B (en) * | 2017-05-19 | 2023-04-21 | 华南理工大学 | Rotary clamping type full knee replacement tibia support and tibia gasket assembly structure and implementation method |
| CN107397583A (en) * | 2017-06-28 | 2017-11-28 | 芜湖启泽信息技术有限公司 | A kind of medical shin bone fixing device of 3D printing and preparation method thereof |
| CN107397589A (en) * | 2017-06-28 | 2017-11-28 | 芜湖启泽信息技术有限公司 | A kind of 3D printing navigation template and its manufacture method for aiding in shin bone prosthesis |
| CN108926411A (en) * | 2018-07-25 | 2018-12-04 | 嘉思特华剑医疗器材(天津)有限公司 | Fixed platform type separate room knee-joint prosthesis and tibial plateau prosthetic designs method |
| CN109549763A (en) * | 2019-01-09 | 2019-04-02 | 上海交通大学医学院附属第九人民医院 | A kind of distal femur list condyle of 3D printing personalization rebuilds prosthese and preparation method thereof |
| CN109549763B (en) * | 2019-01-09 | 2021-03-23 | 上海交通大学医学院附属第九人民医院 | 3D printing personalized femoral distal unicondylar reconstruction prosthesis and preparation method thereof |
| CN111685917A (en) * | 2019-03-15 | 2020-09-22 | 北京纳通科技集团有限公司 | Method for matching tibial prosthesis and tibia and processor |
| CN111685917B (en) * | 2019-03-15 | 2023-09-29 | 北京纳通医疗科技控股有限公司 | Method and processor for matching tibial prosthesis with tibia |
| CN112113836A (en) * | 2020-03-02 | 2020-12-22 | 四川大学 | Intra-articular pressure and bone non-contact strain measurement system based on 3D printing |
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Application publication date: 20140618 |
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