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CN103340705B - 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
CN103340705B
CN103340705B CN201310308397.6A CN201310308397A CN103340705B CN 103340705 B CN103340705 B CN 103340705B CN 201310308397 A CN201310308397 A CN 201310308397A CN 103340705 B CN103340705 B CN 103340705B
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artificial nucleus
intervertebral disc
data
personalized
printer
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CN201310308397.6A
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Chinese (zh)
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CN103340705A (en
Inventor
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

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Neurology (AREA)
  • Physics & Mathematics (AREA)
  • Geometry (AREA)
  • Manufacturing & Machinery (AREA)
  • Prostheses (AREA)

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 maximum vesselless tissue of human body, is the high special structure be made up of multiple connective tissue, comprises vertebral pulp, fibrous ring and cartilage endplate, the physiological function that these structurally ordered rational arrangements make intervertebral disc bring into normal play.Due to extraneous factor or/and increase institute in age extremely aging to make intervertebral disc generation degenerative change, its clinical manifestation is waist, has a pain in the leg bitterly, intervertebral disc afunction time serious.
At present, intervertebral disc marrow nuclear excising art or spinal fusion to the traditional therapy of degenerative disc illness, the former needs surgical removal vertebral pulp, the excision of functional intervertebral disc vertebral pulp will inevitably cause intervertebral height to reduce, the original biomechanical property of intervertebral disc is very easily caused to be lost, potential the risk causing intervertebral disc to degenerate further; The latter induces the skeletonization between soleplate due to the fusion of vertebral body, although can stable disease region, but decrease the range of movement of spinal column, compensation due to spinal column can cause the generation of Adjacent segment degeneration, and because itself being a kind of Highly invasive art formula, operation wound is comparatively large, though therefore above-mentioned two kinds of methods can remove patient pain to a certain extent, all there is such or such complication.
In the time reaching 75 years, many surgeon and engineers and technicians attempt design, development artificial intervertebral disk, to maintain the mobility of pathological interspinal dish sections, prevent other sections intervertebral disc degeneration.According to chapter 13 Section three record in " the vertebral column intervertebral joint urethroptasty " edited by gold the earth, Qu Dongbin, Charles D.Ray of the printing and publishing in June, 2004 of scientific and technical literature publishing house, 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 being put into clinical trial is very few.Section four of this book provides a kind of lumbar intervertebral disc artificial nucleus prosthese, it is the half mobility hydrogel nucleus (poly-third ethylene nitrile-polyacrylamide amine copolymer) by high-molecular polythene overcoat and Qi Nei, its profile is wedge shape and two kinds, rectangle, by Charles doctor D.Ray is invented, be also uniquely be applied to clinical artificial nucleus prosthese at present.The moisture of the own weight 80% of Absorbable rod after this intervertebral disc artificial nucleus expands completely, and its volume can change with load, during use and special fibrous ring expander, Laminoplasty spreader, prosthese try film, implant guide, to hold the apparatuses such as prosthese clamps, 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 receive the operation of this Using prosthesis.Postoperative follow-up investigation finds that its clinical effectiveness is not of great satisfaction yet, and Problems existing is the prostheses migration implanted; 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, row laminectomy remove osseous tissue at least reach the wide service aisle of 12mm could update apparatus, therefore wound is large.
For the problems referred to above, Chinese patent ZL200620020591.X devises the artificial nucleus prosthese that a kind of percutaneous puncture implants intervertebral disc, this prosthese is elongated, overall state in spiral shape, uses this utility model not need surgical operation, the service aisle set up when utilizing percutaneous puncture to extract vertebral pulp, this utility model is pulled open, implanted by service aisle, simple to operate, wound is little; Do not affect intervertebral disc structure after implantation complete, good stability, after recovery, effectively can ensure the biomechanical function of normal disc.Although this kind of prosthese can overcome to operate on implant the large problem of wound, but because the size of human intervertebral disc, form are different, this kind of prosthese also just can roughly make several specification according to the measurement of human body, clinical actual requirement can not be met, and if prosthesis size is not inconsistent, easily bring a lot of drawback, such as shakiness, displacement etc. in dish.Therefore, need to design a kind of intervertebral disc artificial nucleus prosthese manufacturing installation that can carry out personalized designs according to different patient features.
3D printer, i.e. a kind of machine of Rapid Prototyping technique, it is based on a kind of mathematical model file, uses powdery metal or plastics etc. can jointing material, is carried out the technology of constructed object by the mode successively printed.The field such as Making mold, industrial design of being everlasting in the past is used to modeling, existing just gradually for the direct manufacture of some products, means that this technology is popularized.By 3D printer applications in medical field, perhaps new approaches can be provided for personalized designs intervertebral disc artificial nucleus prosthese.
Summary of the invention
The object 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 designs according to the feature of patient, easily because size is not inconsistent and causes coiling the problems such as interior shakiness, displacement.
Another object of the present invention is to provide 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 acquiring instrument, central processing unit and 3D printer, information acquiring instrument is connected with 3D printer by central processing unit, and the printhead of 3D printer is equipped with medical macromolecular materials; The artificial nucleus prosthese produced is strip, and width is 2-6mm, and thickness is 5-9mm, overall appearance state in spiral shape, and the overall dimensions after spiraling is longitudinal diameter is 8-22mm, and trans D is 18-38mm.
Described information acquiring 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 data base, the data compilation that described data base is gathered by information acquiring instrument forms.
Two, a personalized intervertebral disc artificial nucleus prosthese manufacture method, the method comprises the following steps:
(1) information acquiring instrument image data, and be transferred to 3D printer by central processing unit;
(2) 3D printer is according to data, by medical macromolecular materials printing shaping, produces artificial nucleus prosthese;
(3) data that information acquiring instrument collects are assembled into data base's storage.
Adopt the good effect of technique scheme: the present invention can produce satisfactory artificial nucleus prosthese according to the vertebral pulp size personalization of different patient, be used for the treatment of lumbar vertebral disc disease, overcome existing artificial nucleus prosthese can only produce fixing several specifications, the problem of actual needs can not be met, thus solve because artificial nucleus prosthesis size is not inconsistent the problems such as dish interior shakiness, the displacement caused; In addition, the patient data collected is assembled into data base, is convenient to follow-up comparison work, if again run into the patient of data coincidence, directly print nucleus prosthesis, the work before not needing repetition, time saving and energy saving.
Accompanying drawing explanation
Fig. 1 is schematic diagram of the present invention;
Fig. 2 is the artificial nucleus prosthese deployed condition schematic diagram produced;
Fig. 3 is that the artificial nucleus prosthese produced spirals view.
In figure, 1 information acquiring instrument, 2 central processing units, 3 3D printers, 4 artificial nucleus prostheses, 5 data bases.
Detailed description of the invention
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 schematic diagram of the present invention, Fig. 2 is the artificial nucleus prosthese deployed condition schematic diagram produced, Fig. 3 is that the artificial nucleus prosthese produced spirals view, shown in composition graphs 1, Fig. 2, Fig. 3, a kind of personalized intervertebral disc artificial nucleus prosthese manufacturing installation, this device comprises information acquiring instrument 1, central processing unit 2 and 3D printer 3, and information acquiring 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 acquiring 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 is for gathering the sized data of human body vertebral pulp, send 3D printer 3 to by central processing unit 2, provide data basis for 3D printer 3 prints artificial nucleus prosthese.Medical macromolecular materials can use some high polymers, and such as, polyethylene, polypropylene etc., the medical macromolecular materials in the present invention are polyvinyl alcohol hydrogel, and through clinical proof, it acts on human non-toxic's evil, is 50 years service life.The artificial nucleus prosthese 4 produced is strip, and width is 2-6mm, and thickness is 5-9mm, overall appearance state in spiral shape, and the overall dimensions after spiraling is longitudinal diameter is 8-22mm, and trans D is 18-38mm.The advantage of this kind of artificial nucleus prosthese 4 does not need surgical operation, artificial nucleus prosthese is pulled open, the service aisle set up when then utilizing percutaneous puncture to extract vertebral pulp is implanted, simple to operate, wound is little, and the artificial nucleus prosthese after implantation is in spiral shape in intercalated disc is full of intercalated disc, does not affect intervertebral disc structure complete, good stability, effectively can ensure the biomechanical function of normal disc after 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 acquiring instrument 1 forms.Because whole manufacturing process is consuming time long, therefore, the benefit making data base can store the patient data collected to a greater extent, when Resurvey is to patient data, available data can compare in advance and in data base, and if existing data occur overlapping, then do not need to redesign, only need direct printing and making, time saving and energy saving.
embodiment 2
A kind of personalized intervertebral disc artificial nucleus prosthese manufacture method, the method comprises the following steps:
(1) information acquiring instrument 1 image data, and be transferred to 3D printer 3 by central processing unit 2, provide data basis for 3D printer prints artificial nucleus prosthese;
(2) data that collect according to information acquiring instrument 1 of 3D printer 3, by medical macromolecular materials printing shaping, produce artificial nucleus prosthese 4;
(3) data that information acquiring instrument 1 collects are assembled into data base 5 to store, for later work provides Data support, when Resurvey is to patient data, available data can compare in advance and in data base, if with overlapping appears in existing data, then do not need to redesign, only need direct printing and making.
test example
Technical scheme of the present invention is through fresh cadaver test, and because fresh cadaver is close to human normal state, result of study is reliable.Through MRI, corpse vertebral pulp size is measured, the artificial nucleus prosthese of corpse vertebral pulp size is gone out to meet according to this design data, after in artificial nucleus Using prosthesis corpse body, MRI Resurvey data, contrast with above-mentioned data, coincide with intervertebral disc after finding Using prosthesis good, reach target in advance.Then corpse is dissected, find to implant rear prosthese without displacement or unstable phenomenon.
Verified, the present invention can carry out personalized designs according to the different size of patient's vertebral pulp, produce the artificial nucleus prosthese that precision meets patient size's size, overcome the problem that artificial nucleus prosthese in the past only has several fixing specification, effectively prevent because prosthesis size is not inconsistent the problem such as shakiness, displacement in the dish occurred.

Claims (4)

1. a personalized intervertebral disc artificial nucleus prosthese manufacturing installation, it is characterized in that: this device comprises information acquiring instrument (1), central processing unit (2) and 3D printer (3), information acquiring 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) produced is strip, and width is 2-6mm, and thickness is 5-9mm, overall appearance state in spiral shape, and the overall dimensions after spiraling is longitudinal diameter is 8-22mm, and trans D is 18-38mm; Also comprise data base (5), the data compilation that described data base (5) is gathered by information acquiring instrument (1) forms, when Resurvey is to patient data, available data can compare in advance and in data base, if with overlapping appears in existing data, then do not need to redesign, only need direct printing and making.
2. personalized intervertebral disc artificial nucleus prosthese manufacturing installation according to claim 1, is characterized in that: described information acquiring 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, is characterized in that: described medical macromolecular materials are polyvinyl alcohol hydrogel.
4. a personalized intervertebral disc artificial nucleus prosthese manufacture method, is characterized in that: the method comprises the following steps:
(1) information acquiring instrument (1) image data, and be transferred to 3D printer (3) by central processing unit (2);
(2) 3D printer (3) is according to data, by medical macromolecular materials printing shaping, produces artificial nucleus prosthese (4);
(3) data that information acquiring instrument (1) collects are assembled into data base (5) storage;
(4) when Resurvey is to patient data, available data can compare in advance and in data base, and if existing data occur overlapping, then do not need to redesign, only need direct printing and making.
CN201310308397.6A 2013-07-23 2013-07-23 Personalized lumbar intervertebral disc artificial nucleus prosthesis manufacturing device and method Expired - Fee Related CN103340705B (en)

Priority Applications (2)

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CN201310308397.6A CN103340705B (en) 2013-07-23 2013-07-23 Personalized lumbar intervertebral disc artificial nucleus prosthesis manufacturing device and method
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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CN103340705B (en) * 2013-07-23 2015-05-20 林杨 Personalized lumbar intervertebral disc artificial nucleus prosthesis manufacturing device and method
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
CN108601662B (en) 2015-12-16 2021-01-12 纽文思公司 Porous spinal fusion implant
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
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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CN203341867U (en) * 2013-07-23 2013-12-18 林杨 Individual intervertebral disc artificial nucleus prosthesis manufacturing device

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