CN103340705A - Personalized lumbar intervertebral disc artificial nucleus prosthesis manufacturing device and method - Google Patents

Personalized lumbar intervertebral disc artificial nucleus prosthesis manufacturing device and method Download PDF

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Publication number
CN103340705A
CN103340705A CN2013103083976A CN201310308397A CN103340705A CN 103340705 A CN103340705 A CN 103340705A CN 2013103083976 A CN2013103083976 A CN 2013103083976A CN 201310308397 A CN201310308397 A CN 201310308397A CN 103340705 A CN103340705 A CN 103340705A
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artificial nucleus
intervertebral disc
personalized
printer
nucleus prosthesis
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CN2013103083976A
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CN103340705B (en
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林杨
曹汉辉
张忠峰
付源博
髙瑾
林均利
董长和
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Priority to PCT/CN2013/001250 priority patent/WO2015010223A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2/30942Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108Shapes
    • A61F2002/30199Three-dimensional shapes
    • A61F2002/30291Three-dimensional shapes spirally-coiled, i.e. having a 2D spiral cross-section
    • A61F2002/30293Cylindrical body made by spirally rolling up a sheet or a strip around itself
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2/30942Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30948Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using computerized tomography, i.e. CT scans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2002/30985Designing or manufacturing processes using three dimensional printing [3DP]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442Intervertebral or spinal discs, e.g. resilient
    • A61F2002/444Intervertebral or spinal discs, e.g. resilient for replacing the nucleus pulposus

Abstract

The invention relates to a personalized lumbar intervertebral disc artificial nucleus prosthesis manufacturing device and method. The personalized lumbar intervertebral disc artificial nucleus prosthesis manufacturing device comprises an information collector, a central processor and a 3D printer. The information collector is connected with the 3D printer through the central processor, and a printing head of the 3D printer is provided with medical polymer materials. A manufactured artificial nucleus prosthesis is long-bar-shaped, width of the manufactured artificial nucleus prosthesis is 2-6 mm, the thickness of the manufactured artificial nucleus prosthesis is 5-9 mm, and the overall appearance of the artificial nucleus prosthesis is in a spiral state. According to the appearance dimension after spiraling, the longitudinal diameter is 8-22 mm, and the horizontal diameter is 18-38 mm. The invention further provides a personalized lumbar intervertebral disc artificial nucleus prosthesis manufacturing method. The personalized lumbar intervertebral disc artificial nucleus prosthesis manufacturing device manufactures artificial nucleus prostheses meeting the requirements according to nucleus sizes of different users in a personalized mode, and is used for treatment of lumbar intervertebral disc diseases, overcomes the defects that an existing artificial nucleus prosthesis can only manufacture prostheses of fixed several specifications and cannot meet practical needs, and solves the problems that the interior of the disc is unstable and displacement happens due to fact that the sizes of the artificial nucleus prostheses are not fit with the users.

Description

A kind of personalized intervertebral disc artificial nucleus prosthese manufacturing installation and method
Technical field
The invention belongs to medical instruments field, relate to a kind of personalized intervertebral disc artificial nucleus prosthese manufacturing installation and method.
Background technology
Intervertebral disc is the vesselless tissue of human body maximum, is the high special structure that is made of multiple connective tissue, comprises vertebral pulp, fibrous ring and cartilage endplate, the physiological function that these structurally ordered rational arrangements are brought into normal play intervertebral disc.Because extraneous factor is or/and increase the age institute aging intervertebral disc generation degenerative change that makes extremely, its clinical manifestation is waist, the pain that has a pain in the leg, intervertebral disc afunction in the time of seriously.
At present, traditional therapy to the intervertebral disc degeneration illness is intervertebral disc marrow nuclear excising art or spinal fusion, the former needs the surgical removal vertebral pulp, the excision of functional nucleus pulposus will inevitably cause intervertebral height to reduce, very easily cause the forfeiture of the original biomechanical property of intervertebral disc, potential the risk that causes intervertebral disc further to degenerate; The latter is because the skeletonization between soleplate has been brought out in the fusion of vertebral body, although can the stable disease zone, but reduced the range of movement of spinal column, because the compensation of spinal column can cause the generation of neighbouring section regression, and because itself being a kind of height aggressive art formula, operation wound is bigger, though therefore above-mentioned two kinds of methods can be removed patient's pain to a certain extent, all exists such or such complication.
Reaching in the time in 75 years, many surgeon and engineers and technicians attempt design, development artificial intervertebral disk, to keep the mobility of pathological interspinal dish sections, prevent other sections intervertebral disc degeneration.Chapter 13 the 3rd joint by in golden the earth, Qu Dongbin, Charles D.Ray chief editor " vertebral column intervertebral joint urethroptasty " according to the printing and publishing in June, 2004 of scientific and technical literature publishing house is put down in writing, nearly 100 kinds of artificial intervertebral disks are patented, but only a few is by platform load test, cadaver sample or animal Implantation Test, and the product that is put into clinical trial is very few.The 4th joint of this book provides a kind of lumbar intervertebral disc artificial nucleus prosthese, it is by the half mobile hydrogel nucleus of high-molecular polythene overcoat and Qi Nei (poly-third ethylene nitrile-polyacrylamide copolymer), its profile is two kinds in wedge shape and rectangle, by Charles doctor D.Ray is invented, it also is at present unique clinical artificial nucleus prosthese that is applied to.Moisture that can the weight 80% of absorption own after the complete expansion of this intervertebral disc artificial nucleus, and its volume can change with load, during use with special-purpose fibrous ring expander, vertebral plate dilator, prosthese examination film, implant guide, to hold apparatuses such as prosthese pincers, round end propeller, elbow localizer supporting.The extensive use in Europe of above-mentioned lumbar intervertebral disc artificial nucleus prosthese, the existing 3000 many cases patients in the whole world have accepted this prosthese implant surgery.The follow-up investigation of postoperative finds that its clinical effectiveness does not make us extremely being satisfied with yet, and the problem of existence is the prostheses migration of implanting; In addition, when implanting this lumbar intervertebral disc artificial nucleus prosthese, its art formula and conventional way of escape vertebral lamina fenestration, resection of nucleus pulposus are identical, and the row laminectomy is removed osseous tissue and reached the wide service aisle of 12mm at least and could insert operating apparatus, so wound is big.
At the problems referred to above, Chinese patent ZL200620020591.X has designed the artificial nucleus prosthese that a kind of percutaneous puncture is implanted intervertebral disc, this prosthese is elongated, integral body is bank position, uses this utility model not need surgical operation, the service aisle of setting up when utilizing percutaneous puncture to extract vertebral pulp, this utility model is drawn back, implant by service aisle, simple to operate, wound is little; It is complete not influence intervertebral disc structure after the implantation, and good stability can effectively guarantee the biomechanics function of normal disc after the recovery.Though this kind prosthese can overcome the big problem of wound of implanting of operating on, but because size, the form of human intervertebral disc have nothing in common with each other, this kind prosthese also just can roughly be made several specifications according to the measurement of human body, can not satisfy clinical actual requirement, if and prosthesis size is not inconsistent, bring a lot of drawbacks easily, for example shakiness, displacement etc. in the dish.Therefore, need a kind of intervertebral disc artificial nucleus prosthese manufacturing installation that can carry out personalized design according to different patient's characteristics of design.
The 3D printer, i.e. a kind of machine of Rapid Prototyping technique, it is that a kind of mathematical model file is the basis, but uses jointing materials such as powdery metal or plastics, comes the technology of constructed object by the mode of successively printing.The fields such as mould manufacturing, industrial design of being everlasting in the past are used to modeling, and the existing direct manufacturing that is used for some products just gradually means that this technology is universal.In medical field, perhaps can provide new approaches for personalized design intervertebral disc artificial nucleus prosthese with the 3D printer applications.
Summary of the invention
The purpose of this invention is to provide a kind of personalized intervertebral disc artificial nucleus prosthese manufacturing installation, solving existing artificial nucleus prosthese can not carry out personalized design according to patient's characteristics, easily because size is not inconsistent problems such as causing coiling interior shakiness, displacement.
Another object of the present invention provides a kind of personalized intervertebral disc artificial nucleus prosthese manufacture method.
The present invention is achieved through the following technical solutions:
One, a kind of personalized intervertebral disc artificial nucleus prosthese manufacturing installation, this device comprises information gathering instrument, central processing unit and 3D printer, the information gathering instrument is connected with the 3D printer by central processing unit, and the printhead of 3D printer is equipped with medical macromolecular materials; The artificial nucleus prosthese that produces is strip, and width is 2-6mm, and thickness is 5-9mm, and overall appearance is bank position, and the overall dimensions after spiraling is that vertical diameter is 8-22mm, and trans D is 18-38mm.
Described information gathering instrument is nuclear magnetic resonance imaging system (being called for short MRI) or computed tomography system (being called for short CT).
Described medical macromolecular materials are polyvinyl alcohol hydrogel.
As a further improvement on the present invention, also comprise the data base, the data compilation that described data base is gathered by the information gathering instrument forms.
Two, a kind of personalized intervertebral disc artificial nucleus prosthese manufacture method, this method may further comprise the steps:
(1) information gathering instrument image data, and be transferred to the 3D printer by central processing unit;
(2) the 3D printer with the medical macromolecular materials printing shaping, produces the artificial nucleus prosthese according to data;
(3) data sink that the information gathering instrument is collected is weaved into database stores.
Adopt the good effect of technique scheme: the present invention can produce satisfactory artificial nucleus prosthese according to different patients' vertebral pulp size personalization, be used for the treatment of lumbar vertebral disc disease, overcome existing artificial nucleus prosthese and can only produce fixing several specifications, can not satisfy the problem of actual needs, thereby solved because the artificial nucleus prosthesis size is not inconsistent problems such as shakiness, displacement in the dish that causes; In addition, the patient data that collects is assembled into the data base, is convenient to follow-up comparison work, if run into the patient that data overlap again, directly print nucleus prosthesis and get final product, do not need repetition work before, time saving and energy saving.
Description of drawings
Fig. 1 is sketch map of the present invention;
Fig. 2 is the artificial nucleus prosthese deployed condition sketch map that produces;
Fig. 3 is the artificial nucleus prosthese that the produces view of spiraling.
Among the figure, 1 information gathering instrument, 2 central processing units, 3 3D printers, 4 artificial nucleus prostheses, 5 data bases.
The specific embodiment
Below by embodiment and test example technical scheme of the present invention is described further, but should not be construed as limitation of the present invention:
Embodiment 1
Fig. 1 is sketch map of the present invention, Fig. 2 is the artificial nucleus prosthese deployed condition sketch map that produces, Fig. 3 is the artificial nucleus prosthese that the produces view of spiraling, in conjunction with Fig. 1, Fig. 2, shown in Figure 3, a kind of personalized intervertebral disc artificial nucleus prosthese manufacturing installation, this device comprises information gathering instrument 1, central processing unit 2 and 3D printer 3, and information gathering instrument 1 is connected with 3D printer 3 by central processing unit 2, and the printhead of 3D printer 3 is equipped with medical macromolecular materials.Described information gathering instrument 1 is nuclear magnetic resonance imaging system (being called for short MRI) or computed tomography system (being called for short CT), MRI and CT are used for gathering the sized data of human body vertebral pulp, send 3D printer 3 to by central processing unit 2, provide the data basis for 3D printer 3 prints the artificial nucleus prosthese.Medical macromolecular materials can use some high polymers, for example, polyethylene, polypropylene etc., the medical macromolecular materials among the present invention are polyvinyl alcohol hydrogel, through clinical proof its to human body nonhazardous effect, be service life 50 years.The artificial nucleus prosthese 4 that produces is strip, and width is 2-6mm, and thickness is 5-9mm, and overall appearance is bank position, and the overall dimensions after spiraling is that vertical diameter is 8-22mm, and trans D is 18-38mm.The advantage of this kind artificial nucleus prosthese 4 is not need surgical operation, the artificial nucleus prosthese is drawn back, the service aisle of setting up when utilizing percutaneous puncture to extract vertebral pulp is then implanted, simple to operate, wound is little, and the artificial nucleus prosthese after the implantation is spiral and is full of intercalated disc in intercalated disc, and it is complete not influence intervertebral disc structure, good stability can effectively guarantee the biomechanics function of normal disc after the recovery.
As a further improvement on the present invention, also comprise data base 5, the data compilation that described data base 5 is gathered by information gathering instrument 1 forms.Because entire making process is consuming time long, therefore, the benefit of making the data base is to store the patient data that collects to a greater extent, when collecting patient data again, can be in advance with the data base in available data compare, and if existing data occur overlapping, then do not need redesign, only need direct printing and making to get final product, time saving and energy saving.
Embodiment 2
A kind of personalized intervertebral disc artificial nucleus prosthese manufacture method, this method may further comprise the steps:
(1) information gathering instrument 1 image data, and be transferred to 3D printer 3 by central processing unit 2, for printing the artificial nucleus prosthese, the 3D printer provides the data basis;
(2) data that collect according to information gathering instrument 1 of 3D printer 3 with the medical macromolecular materials printing shaping, produce artificial nucleus prosthese 4;
(3) data sink that information gathering instrument 1 is collected is weaved into data base's 5 storages, for later work provides the data support, when collecting patient data again, can be in advance with the data base in available data compare, if and overlapping appears in existing data, then do not need redesign, only need direct printing and making to get final product.
The test example
Technical scheme of the present invention is through fresh cadaver test, because fresh cadaver is near the human body normal condition, result of study is reliable.Measure through the corpse vertebral pulp of MRI size, go out to meet the artificial nucleus prosthese of corpse vertebral pulp size according to this design data, after implanting the artificial nucleus prosthese in the corpse body, MRI is image data again, compare with above-mentioned data, find that prosthese is implanted the back and intervertebral disc is identical good, reach target in advance.Then corpse is dissected, find to implant the back prosthese and do not have displacement or unstable phenomenon.
Verified, the present invention can carry out personalized design according to the different size of patient's vertebral pulp, produce the artificial nucleus prosthese that precision meets patient's size, overcome the problem that artificial nucleus prosthese in the past has only several fixedly specifications, effectively prevented because prosthesis size is not inconsistent problems such as shakiness, displacement in the dish of appearance.

Claims (5)

1. personalized intervertebral disc artificial nucleus prosthese manufacturing installation, it is characterized in that: this device comprises information gathering instrument (1), central processing unit (2) and 3D printer (3), information gathering instrument (1) is connected with 3D printer (3) by central processing unit (2), and the printhead of 3D printer (3) is equipped with medical macromolecular materials; The artificial nucleus prosthese (4) that produces is strip, and width is 2-6mm, and thickness is 5-9mm, and overall appearance is bank position, and the overall dimensions after spiraling is that vertical diameter is 8-22mm, and trans D is 18-38mm.
2. personalized intervertebral disc artificial nucleus prosthese manufacturing installation according to claim 1 is characterized in that: described information gathering instrument (1) is nuclear magnetic resonance imaging system or computed tomography system.
3. personalized intervertebral disc artificial nucleus prosthese manufacturing installation according to claim 1, it is characterized in that: described medical macromolecular materials are polyvinyl alcohol hydrogel.
4. personalized intervertebral disc artificial nucleus prosthese manufacturing installation according to claim 1 is characterized in that: also comprise data base (5), the data compilation that described data base (5) is gathered by information gathering instrument (1) forms.
5. personalized intervertebral disc artificial nucleus prosthese manufacture method, it is characterized in that: this method may further comprise the steps:
(1) information gathering instrument (1) image data, and be transferred to 3D printer (3) by central processing unit (2);
(2) 3D printer (3) with the medical macromolecular materials printing shaping, produces artificial nucleus prosthese (4) according to data;
(3) data sink that information gathering instrument (1) is collected is weaved into data base (5) storage.
CN201310308397.6A 2013-07-23 2013-07-23 Personalized lumbar intervertebral disc artificial nucleus prosthesis manufacturing device and method Active CN103340705B (en)

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PCT/CN2013/001250 WO2015010223A1 (en) 2013-07-23 2013-10-15 Apparatus and method for fabricating personalized intervertebral disc artificial nucleus prosthesis

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WO2015010223A1 (en) * 2013-07-23 2015-01-29 Lin Yang Apparatus and method for fabricating personalized intervertebral disc artificial nucleus prosthesis
CN108355168A (en) * 2018-05-14 2018-08-03 上海交通大学医学院附属第九人民医院 A kind of method that combination three-dimensional printing technology prepares nucleus pulposus time implant

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JP2018537235A (en) 2015-12-16 2018-12-20 ニューヴェイジヴ,インコーポレイテッド Porous spinal fusion implant
CN110464875A (en) * 2019-09-05 2019-11-19 上海交通大学医学院附属第九人民医院 A kind of artificial intervertebral's disc carrier of electrostatic curly wire 3 D-printing and preparation method thereof

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US20110144752A1 (en) * 2008-08-14 2011-06-16 Defelice Scott F Customized implants for bone replacement
CN103150442A (en) * 2013-03-15 2013-06-12 常州华森医疗器械有限公司 Manufacturing technique of digitally customizing orthopedic implants
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WO2015010223A1 (en) * 2013-07-23 2015-01-29 Lin Yang Apparatus and method for fabricating personalized intervertebral disc artificial nucleus prosthesis
CN103860294A (en) * 2014-03-07 2014-06-18 北京大学第三医院 Individualized design and manufacturing system and method for full knee joint replacing prosthesis
CN108355168A (en) * 2018-05-14 2018-08-03 上海交通大学医学院附属第九人民医院 A kind of method that combination three-dimensional printing technology prepares nucleus pulposus time implant

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