CN107661160A - A kind of bone repairing support and preparation method thereof - Google Patents

A kind of bone repairing support and preparation method thereof Download PDF

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Publication number
CN107661160A
CN107661160A CN201610608414.1A CN201610608414A CN107661160A CN 107661160 A CN107661160 A CN 107661160A CN 201610608414 A CN201610608414 A CN 201610608414A CN 107661160 A CN107661160 A CN 107661160A
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CN
China
Prior art keywords
support
duct
bone
bone repairing
cylindrical
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Pending
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CN201610608414.1A
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Chinese (zh)
Inventor
李波
张国伟
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Beijing Shape Dream Information Technology Co Ltd
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Beijing Shape Dream Information Technology Co Ltd
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Publication date
Application filed by Beijing Shape Dream Information Technology Co Ltd filed Critical Beijing Shape Dream Information Technology Co Ltd
Priority to CN201610608414.1A priority Critical patent/CN107661160A/en
Priority to PCT/CN2017/094196 priority patent/WO2018019215A1/en
Publication of CN107661160A publication Critical patent/CN107661160A/en
Pending legal-status Critical Current

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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
    • A61F2/28—Bones
    • 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
    • A61F2/28—Bones
    • A61F2/2846—Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
    • A61L27/04—Metals or alloys
    • A61L27/06—Titanium or titanium alloys
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y10/00—Processes of additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y50/00—Data acquisition or data processing for additive manufacturing
    • 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
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • A61F2240/002—Designing or making customized prostheses

Abstract

The invention belongs to technical field of biomedical materials, and in particular to a kind of bone repairing support and preparation method thereof.A kind of bone repairing support, the support are the loose structure to match with the size at the Cranial defect position of patient.A kind of preparation method of bone repairing support, including step：S100, the design entity of the support is built by Three-dimensional Design Software；S110, build the threedimensional model of porous matrix structure construction unit；S200, by Three-dimensional Design Software, with the construction unit filling design entity of threedimensional model, design entity is produced as porous matrix structure；S300, by 3D printer, more matrix structures are printed, obtain printout.Support of the present invention can be used for repairing bone defect, skeletonization can be strengthened into the ability of blood vessel, in the cavity formed at implantable large segmental bone defect or after early ischemic necrosis of femoral head focal cleaning, play a part of biomethanics support and promote blood vessel and bone tissue to grow into.

Description

A kind of bone repairing support and preparation method thereof
Technical field
The invention belongs to technical field of biomedical materials, and in particular to a kind of bone repairing support and preparation method thereof.
Background technology
Large segmental bone defect caused by the diseases such as wound, infection, tumour is still the great challenges of clinical treatment, therapeutic effect One of the reason for bad is exactly the avascular of bone graft or bone alternate material：And effective disperse of oxygen and nutriment in vivo Distance only 200um.Traditional bone graft and organizational project bone alternate material is no microcirculqtory system mostly.Graft Central area can not obtain required oxygen and nutriment, so as to easily causing Bone graft healing to fail.
Caput femoris necrosis is the common and refractory disease of field of orthopaedics.If without effectively treatment, about 80% patient's meeting Collapse of femoral head, subsequent articular dysfunction occurred in 4 years, final patient has to receive artificial joint replacement, manually The high cost of joint replacement brings huge financial burden to patient and society, and because joint prosthesis has certain longevity Life, the problem of often also facing joint mobilization after the joint replacement of middle-young patients, joint prosthesis, which will be overhauled, further to be aggravated Financial burden and the quality of life for reducing patient.Therefore early treatment caput femoris necrosis, to retain the treatment in patient itself joint Method receives much concern always.
Early stage removes focus, the use of be implanted into material filling support defect area and promote osteanagenesis is current research and clinic One of focus for the treatment of.Stem-cell therapy, artificial filling material of bone and stent in the treatment etc. are taken in the investigation of materials of the past, so And gratifying therapeutic effect is not obtained.Because the Important cause of disease of caput femoris necrosis be in its lesion region blood supply it is impaired or Interrupt, although these materials are with good support or promote bone formation performance, it can be difficult to rebuilding the microcirculation system of lesion region System, therefore necessary nutrition and removing metabolic waste can not be provided for the stem cell of injection or the bone tissue of new life, so that can not Obtain preferable therapeutic effect.
In summary, that repairs large segmental bone defect and femoral head osteonecrosis focuses on solving following three problems：
1st, the biomethanics support in Cranial defect region；2nd, the reconstruction of local microcirculation system；3rd, the regeneration of bone tissue is promoted Repair.
The content of the invention
In view of the above-mentioned problems, the present invention proposes a kind of bone repairing support and preparation method thereof, the support can be used for repairing Multiple Cranial defect, can strengthen skeletonization into the ability of blood vessel.
A kind of bone repairing support, the support are the loose structure to match with the size at the Cranial defect position of patient.
A kind of preparation method of bone repairing support, including step：S100, the support is built by Three-dimensional Design Software Design entity；S110, build the threedimensional model of porous matrix structure construction unit；S200, by Three-dimensional Design Software, with three-dimensional The construction unit filling design entity of model, porous matrix structure is produced as by design entity；S300 is right by 3D printer More matrix structures are printed, and obtain printout.
Support of the present invention is porous support, at implantable large segmental bone defect or early ischemic necrosis of femoral head disease In the cavity that stove is formed after removing, play a part of biomethanics support and promote blood vessel and bone tissue to grow into；In loose structure Portion can load bioactivity growth factor (such as BMP-2/VEGF etc.) or stem cell so as to further strengthen its promotion osteanagenesis Ability；The single through hole being provided with the support can carry out bone collection or vasotransplantation, strengthen bone tissue and blood vessel is repaiied Reactivation power；Two ducts run through are provided with the support, arteriovenous combined transplantation can be achieved, to promote support and diseased region Blood vessel in domain is grown into, and realizes the reconstruction of necrotic zone microcirculqtory system, for freshman bone tissue provide needed for nutriment and Remove local metabolic waste.
Brief description of the drawings
Fig. 1 is a kind of embodiment of the cylindric porous titanium alloy support of the present invention.
Fig. 2 is the another embodiment of the cylindric porous titanium alloy support of the present invention.
Fig. 3 is a kind of embodiment of the column shape porous titanium alloy support of the present invention.
Fig. 4 is the another embodiment of the column shape porous titanium alloy support of the present invention.
Fig. 5 is the another embodiment of the column shape porous titanium alloy support of the present invention.
Fig. 6 is the schematic diagram of loose structure in Fig. 1 medium-height trestles.
Fig. 7 is the schematic diagram of loose structure in Fig. 2 medium-height trestles.
Fig. 8 is the schematic diagram of loose structure in Fig. 3 medium-height trestles.
Fig. 9 is the schematic diagram of loose structure in Fig. 4 medium-height trestles.
Figure 10 is the schematic diagram of loose structure in Fig. 5 medium-height trestles.
Figure 11 is the structure chart of porous matrix structure unit in the present invention.
Figure 12 is another structure chart of porous matrix structure unit in the present invention.
Figure 13 is the schematic diagram that medium-height trestle of the present invention carries out duct in bone collection fore-stock.
Figure 14 is the schematic diagram that medium-height trestle of the present invention carries out duct in bone collection after-poppet.
Embodiment
Embodiments of the present invention are described with reference to the accompanying drawings, wherein identical part is presented with like reference characters.
Support of the present invention can be used for repairing bone defect, such as large segmental bone defect and femoral head osteonecrosis.Below Some embodiments that the support is column structure are only provided, certain support is not limited only to column structure, the support Appearance and size should be depending on the appearance and size at Cranial defect position, such as large segmental bone defect region, femoral head necrosis pressure reduction are controlled The size of cavity and femoral head neck windowed regions is remained after treatment, can be using CT scan as foundation.
Fig. 1-2 is two kinds of embodiments that support of the present invention is cylindric porous titanium alloy support.The support Appearance and size is depending on Cranial defect position, length and profile, for example, as reparation large segmental bone defect, the size Ying Yu great of support The size in section Cranial defect region matches；When reparation carries out caput femoris necrosis focus in a manner of core decompression removes, support Size should with after patient femur's head necrosis decompression treatment remain cavity match.In Fig. 1-2, the size of cylinder racks can For：A diameter of 10-12mm of support, the length of support is 70-130mm.In Fig. 1, it is provided with a longitudinal direction in the inside of support Cylindrical vent, duct internal diameter can be 5-10mm.In fig. 2, the cylindrical vent of two longitudinal directions is provided with the inside of support, Duct internal diameter can be 3-4mm.
Fig. 3-5 is three kinds of embodiments that support of the present invention is column shape porous titanium alloy support.The support Appearance and size is depending on Cranial defect position, length and profile, for example, as reparation large segmental bone defect, the size Ying Yu great of support The size in section Cranial defect region matches；Caput femoris necrosis focus removing is carried out in a manner of femoral head neck decompression by fenestration when repairing When, the size of support should be depending on the size of patient femur's neck windowed regions.In figs. 3-5, the size of columnar bracket is found Can be：15×25×15mm3.In figure 3, the duct of a straight is provided with the inside of support, duct internal diameter can be 5-10mm. In Fig. 4, two cylindrical vents are provided with the inside of support, duct internal diameter can be 3-5mm.In Figure 5, in the inside of support Duct provided with two arcs, duct internal diameter are 3-5mm.
As illustrated in figures 6-10, the support in Fig. 1-5 is the support with loose structure, has hole post in support, hole post The a width of 100-1000um (intermediate value 300um) of post, aperture are 300-3000um (intermediate value 1000um), and the porosity of support is 70-90%, it is to be imitated with what the filling of porous matrix structure unit, extension obtained with what Cranial defect region profile matched with mechanics The above-mentioned support of natural disposition energy.Wherein, porous matrix structure unit as depicted in figs. 11-12, the knot being of course not solely limited in Figure 11-12 Structure unit.
Support of the present invention is porous titanium alloy support, the material of certain support be alternatively pure titanium, cobalt alloy, tantalum, Titanium tantalum alloy, calcium phosphate, PLA (PLA), poly lactic coglycolic acid (PLGA), poly- acetic acid lactones (PCL), coral, life The bone biologic materials such as thing ceramics, as long as there can be the material of the bionical performance of mechanics.The described support of the present invention can In the cavity formed at implantation large segmental bone defect or after early ischemic necrosis of femoral head focal cleaning, biomethanics branch is played Support and the effect for promoting blood vessel and bone tissue to grow into.Bone Ingrowth is promoted by the design of loose structure, and can be in loose structure Load bioactivity growth factor (such as BMP-2/VEGF) or stem cell are so as to further strengthen its ability for promoting osteanagenesis.
In figures 1 and 3, internal stent has a duct, and the both ends in duct are above support and following, duct Inside can be used for carrying out bone implantation or vasotransplantation (as illustrated in figs. 13-14), to strengthen the local Bone Defect Repari ability in lesion, branch Frame can then play a part of biomethanics support and promote blood vessel and bone tissue to grow into.As shown in Fig. 2, Fig. 4 and Fig. 5, in support Portion has two ducts, and the both ends in duct are above cylinder racks and following in fig. 2, in Fig. 4 the both ends in duct Above vertical columnar bracket and below, in Figure 5 duct both ends stand columnar bracket above and side, wherein, one Transplanting and the blood vessel of arterial anastomosis are used as blood supply passage in duct, and the blood vessel of transplanting and venous anastomosis is as blood in another duct The outlet of confession.By two ducts that blood vessel (such as great saphenous vein or neighbouring arteriolovenular beam) is implanted into insertion in support It is interior, and with blood supply system existing near large segmental bone defect or around hip joint (before such as shin/shin after arteriovenous system, outside rotation stock Side arteriovenous system) it coincide, the vascularization of support is realized, is stent area to promote the reconstruction of focus local microcirculation system Stem cell and freshman bone tissue provide needed for nutriment and remove metabolic waste in time.It is pointed out that in support The size in portion duct should match with the bone tissue or blood vessel for needing to be implanted into, thus the size knot being not limited only in accompanying drawing Structure.
The present invention also proposes a kind of preparation method of bone repairing support, and this method can be used for preparing above-mentioned support, certainly not It is only limitted to the support of above-mentioned size.
In one embodiment, step includes：
1) by proe Three-dimensional Design Softwares, the design entity (such as Fig. 1-5) of above-mentioned supporting structure is established in a computer；
2) threedimensional model (such as Fig. 6-10) of porous matrix structure construction unit is built, the unit key element of construction unit is more Hole matrix structure (such as Figure 11-12), the hole post of porous matrix structure is 100-1000um (intermediate value 300um), aperture 200- 3000um (intermediate value 1000um), the porosity 70-90% of support；
3) according to the three-dimensional construction unit in step 2), step is filled with construction unit by magics Three-dimensional Design Softwares 1) design entity of medium-height trestle, design entity is produced as porous matrix structure；
4) according to the porous matrix structure in step 3), using 3D printer, with the bone biology material such as titanium alloy (Ti6Al4V) Material is printed, and printing thickness is 0.025mm；
5) printout that step 4) obtains is heat-treated in stove, under argon gas protective condition, heated up in 4 hours To 840 degrees Celsius, and kept for 2 hours, take out printout after in-furnace temperature then is cooled into 500 degrees Celsius, be put in workbench Go up and naturally cool to room temperature；
6) printout that step 5) obtains is used into wire cutting, cut from workbench；
7) printout that step 6) obtains is used into blasting treatment, removes print surface and glue molten unnecessary raw material；
8) printout that step 7) obtains is cleaned using ultrasonic wave, removes surface impurity；
9) printout is put into high temperature and high pressure steam sterilizer and sterilized, and independent packing is handled.
Embodiment described above, it is the present invention more preferably embodiment, those skilled in the art is at this The usual variations and alternatives carried out in the range of inventive technique scheme should all include within the scope of the present invention.

Claims (10)

  1. A kind of 1. bone repairing support, it is characterised in that：
    The support is the loose structure to match with the size at the Cranial defect position of patient.
  2. 2. bone repairing support according to claim 1, it is characterised in that：
    The material of the support is bone biologic material.
  3. 3. bone repairing support according to claim 1, it is characterised in that：
    The internal stent has one or two ducts for running through support.
  4. 4. bone repairing support according to claim 1, it is characterised in that：
    The porosity of the loose structure is 70-90%,
    Preferably, the size of the hole post of the loose structure is：Post a width of 100-1000um, aperture 300-3000um,
    Preferably, a width of 300um of the post of the hole post, the aperture of hole post is 1000um.
  5. 5. bone repairing support according to claim 4, it is characterised in that：
    The support is columned porous titanium alloy support, and a diameter of 10-12mm of support, the length of support is 70- 130mm, internal stent are provided with a duct for running through cylindrical-shaped structure, and the internal diameter in duct is 5-10mm, or internal stent is set There are two ducts for running through cylindrical-shaped structure, the internal diameter in duct is 3-4mm；Or
    The support is the porous titanium alloy support of column shape, and the size of support is 15 × 25 × 15mm3, internal stent is provided with one Individual the internal diameter in duct be 5-10mm through the duct of vertical column structure, or internal stent is provided with two through founding column structure Duct, the internal diameter in duct is 3-5mm.
  6. 6. a kind of preparation method of bone repairing support, it is characterised in that including step：
    S100, the design entity of the support is built by Three-dimensional Design Software；
    S110, build the threedimensional model of porous matrix structure construction unit；
    S200, by Three-dimensional Design Software, with the construction unit filling design entity of threedimensional model, design entity is produced as more Hole matrix structure；
    S300, by 3D printer, more matrix structures are printed, obtain printout.
  7. 7. the preparation method of bone repairing support according to claim 6, it is characterised in that：
    In step S110, the size of the hole post of the porous matrix structure is：Post a width of 100-1000um, aperture 300- 3000um, it is preferable that a width of 300um of post of hole post, the aperture of hole post is 1000um；The porosity of the porous matrix structure is 70-90%；The unit key element of the construction unit is porous matrix structure unit.
  8. 8. the preparation method of bone repairing support according to claim 6, it is characterised in that：In step S100,
    The threedimensional model is cylindrical-shaped structure, and a diameter of 10-12mm of cylindrical-shaped structure, the length of cylindrical-shaped structure is 70- 130mm, is provided with a duct for running through cylindrical-shaped structure inside cylindrical-shaped structure, and the internal diameter in duct is 5-10mm, or cylinder Shape inside configuration is provided with two ducts for running through cylindrical-shaped structure, and the internal diameter in duct is 3-4mm；Or
    The threedimensional model is vertical column structure, and the size for founding column structure is 15 × 25 × 15mm3, column shape inside configuration sets There is one through the duct of vertical column structure, the internal diameter in duct is 5-10mm, or column shape inside configuration runs through provided with two The duct of vertical column structure, the internal diameter in duct is 3-5mm.
  9. 9. the preparation method of bone repairing support according to claim 6, it is characterised in that：
    In step S300, the raw material using bone biologic material as printing, printing thickness is 0.025mm.
  10. 10. the preparation method of bone repairing support according to claim 6, it is characterised in that also including step：
    S400, under argon gas protection, printout is heat-treated,
    Preferably, step S400 includes step successively：
    S410,840 degrees Celsius were warming up in 4 hours；
    S420, kept for 840 degrees Celsius 2 hours；
    S430, temperature is cooled to 500 degrees Celsius；
    S440, naturally cool to room temperature.
    Preferably, in addition to step：
    S600, remove printout surface and glue molten unnecessary raw material；And/or
    S700, remove the impurity on printout surface；And/or
    S800, sterilization treatment is carried out to printout；And/or
    S900, packing processing is carried out to printout.
CN201610608414.1A 2016-07-29 2016-07-29 A kind of bone repairing support and preparation method thereof Pending CN107661160A (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN201610608414.1A CN107661160A (en) 2016-07-29 2016-07-29 A kind of bone repairing support and preparation method thereof
PCT/CN2017/094196 WO2018019215A1 (en) 2016-07-29 2017-07-25 Bone repair stent and preparation method therefor

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201610608414.1A CN107661160A (en) 2016-07-29 2016-07-29 A kind of bone repairing support and preparation method thereof

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WO (1) WO2018019215A1 (en)

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CN109481108A (en) * 2018-09-28 2019-03-19 西安点云生物科技有限公司 A kind of bioceramic scaffold and preparation method thereof with lateral apertures structure
CN109513050A (en) * 2018-12-17 2019-03-26 广东省新材料研究所 Depth-graded porous structure personalization tantalum implant and the preparation method and application thereof
CN109966027A (en) * 2019-04-28 2019-07-05 华南协同创新研究院 A kind of Bone Defect Repari Gradient Unit, porous support and preparation method
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CN111973810B (en) * 2019-05-23 2022-05-24 浙江大学 Porous hollow tubular material for regeneration, repair and reconstruction of large-section bone defects of limbs and preparation method thereof

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CN103767807A (en) * 2014-01-10 2014-05-07 中国医学科学院整形外科医院 Novel vascularized tissue-engineered bone and construction method thereof
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CN109481108A (en) * 2018-09-28 2019-03-19 西安点云生物科技有限公司 A kind of bioceramic scaffold and preparation method thereof with lateral apertures structure
CN109513050A (en) * 2018-12-17 2019-03-26 广东省新材料研究所 Depth-graded porous structure personalization tantalum implant and the preparation method and application thereof
CN109966027A (en) * 2019-04-28 2019-07-05 华南协同创新研究院 A kind of Bone Defect Repari Gradient Unit, porous support and preparation method
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CN112168429B (en) * 2020-10-14 2021-12-31 华中科技大学 Sea urchin thorn-shaped continuous gradient change-simulating biological scaffold and application thereof

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Application publication date: 20180206