CN1669538A - Artificial bone with biology imitating structure, preparation method and application thereof - Google Patents
Artificial bone with biology imitating structure, preparation method and application thereof Download PDFInfo
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- CN1669538A CN1669538A CN 200510025002 CN200510025002A CN1669538A CN 1669538 A CN1669538 A CN 1669538A CN 200510025002 CN200510025002 CN 200510025002 CN 200510025002 A CN200510025002 A CN 200510025002A CN 1669538 A CN1669538 A CN 1669538A
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Images
Classifications
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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
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
Landscapes
- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The invention relates to the preparing method and the application of the imitation biological structural artificial bone. The artificial bone can copy the body skeleton anatomy configuration and size, and be matching with the bone defection or renovation part. Meanwhile, the intercommunicating pipe system and microcirculation system are formed in the artificial bone, so the endocytosis and organizations can grow into the material, and it can gain enough nutrition to form the functional organizations. The prepare steps and technological process of the invention is to do CT scan to the tendon side anatomy structure, to dispose and converse imitate the acquisition data, to reconstruc the three-dimensional anatomy structure images, to make three-dimensional anatomy structure model by using image data and rapid-speed forming technology, then to make the corresponding model. Make three-dimensional organic network holder according to the designed density distribution and data of vessel. Finally the imitation biological structure artificial bone is produced, and applied to the restore of the bone defection and the remodel of the anatomy structure in orthopedics department, plastic surgery department, dentofacial surgery department, department of eyes, ears, nose, lips and throat, and brain surgery department.
Description
Technical field
The present invention relates to a kind of artificial bone, preparation method and application thereof of biomimetic structure, the present invention relates to the artificial bone and the processing technology of a kind of imitated skeleton anatomical structure and blood circulation system or rather, the product that this technology is made can be applicable to medical domain, especially at orthopaedics, plastic surgery, decorative sursery, department of eye and department of cerebral surgery etc., carry out the damaged reparation of big section and bulk bone and the reconstruction of anatomical structure.Belong to the biomaterial for medical purpose field.
Technical background
Skeleton is the supporting construction of human body, and for damage among a small circle, osseous tissue has self repair ability.But self be difficult to finish reparation for big section (more than 20 millimeters) bone defective bone, need to use the substitution material of bone to repair.This kind repair materials must comprise three big key elements: 1) anatomical structures such as suitable dimension size, geometry and bindiny mechanism are arranged; 2) the suitable tissue growth of material bio-compatible and micro structure; 3) can set up blood circulation, make cell and be organized in the material to obtain enough nutrition supplies.
Along with the continuous development of life sciences and engineering science, people carry out 3D image reconstruction by computer with medical image, and applying fast-forming fabrication techniques threedimensional model solves the anatomical structure profile subsequently.This technology only is used for metal and organic material at present, because their casting and machining ratio are easier to.
Biomaterial has been widely used in clinical medicine, and the porous material of the second filial generation is also accepted by clinicians.But it is damaged only to be used for little bone, plays and fills and the bone guided effect.People want to induce by bone marrow stem cell and somatomedin the formation of bone simultaneously.Still can't solve big bone is damaged, problem is how to ensure the cell and the histotrophic nutrition supply in biomaterial deep, just must set up blood circulation and nutrition supply system in material.
Summary of the invention
The purpose of this invention is to provide a kind of biomimetic structure artificial bone and preparation method, it carries out 3D image reconstruction by computer with medical image, applying fast-forming fabrication techniques threedimensional model is made the anatomical structure profile that bone defect repair position is complementary subsequently.And the blood circulation of skeleton inside is set up in simulation.By setting up intercommunity mesh duct structure, form this blood circulation.Material internal is made porous microstructure simultaneously, makes it form microcirculqtory system.Finally make cell and tissue can grow among the material, and can obtain the tissue that enough nutrition is formed with function.
According to biomimetic structure artificial bone provided by the invention, it is characterized in that:
1. the dissection profile of this artificial bone and size are complementary fully with the defect repair position.This is by the binaryzation data of strong side anatomical structure CT scan collection are carried out 3D image reconstruction and reverse (Fig. 1).Adopt Rapid Prototyping technique to make 3 D anatomy structure model (Fig. 2) and corresponding mould then, also can utilize 3 d image data directly to make mould, the dissection profile and the size (Fig. 3) of making artificial bone by program controlled machine tool.
2. there is intercommunity mesh duct structure (being vascular system) this artificial bone inside.Adopt the pipeline distribution density and the size data of design, make three-dimensional organic network by Rapid Prototyping technique.This framework is disappeared by gasification in the artificial bone forming process, and remaining gap will become tubing (Fig. 4).
3. there is intercommunity porous microstructure (being microcirculqtory system) this artificial bone inside.Be partly dissolved plastic grain or add binding agent by heating and chemical method, make the bonding formation porous of plastic grain framework thing.Bonding environment of scalable granule and time, control the size of granule bounding point, just with the interior connection of metapore.In the framework thing, pour into ceramic serosity subsequently, dry back is heated to 200 ℃ to 400 ℃ and eliminates organic substance in sintering furnace, continue to be warmed up to 800 to 1800 ℃ subsequently, make it sinter the individuation biomimetic structure artificial bone (Fig. 4) that adapts to different patient crowds, different parts needs into.
4. column compact substance pottery enhancing body can be set up in this artificial bone inside, makes mechanical strength increase by 10 times to 100 times than single porous material.Its method is in porous framework thing manufacturing process, reserves the pipeline gap of 1 millimeter to 50 millimeters of 1 to 10 diameter.This pipeline will be formed the compact substance pottery by ceramic serosity complete filling behind the high temperature sintering when grouting.
The preparation method of biomimetic structure artificial bone provided by the invention comprises following nine steps:
1. strong side anatomical structure is carried out CT scan, require interlamellar spacing little, with the accuracy that guarantees to rebuild.General bed thickness is chosen for 0.3-0.5mm and is advisable.
2. the CT binaryzation data that obtain are handled and reverse reconstruction of three-dimensional anatomical structure image.
3. according to 3 d image data, make the 3 D anatomy structure model by Rapid Prototyping technique.Here must make used material shrinkage factor according to artificial bone and add amplification coefficient (1% to 50%).
4. according to the 3 D anatomy structure model, make corresponding mould by turning over modeling method; Also can utilize 3 d image data directly to make mould by program controlled machine tool.
5. according to the vascularity density and the size data of design, applying fast-forming technology or plastics silk Method for bonding are made three-dimensional organic network.
6. organic network after will pruning and metal bar (1 millimeter to 50 millimeters of diameter) are put in the mold cavity, insert plastic grain, filling organic solvent or heating is partly dissolved plastic grain or binding agent bonding (1 minute to 200 minutes time), add water and remove solvent or binding agent or cooling, the demoulding and removal metal bar obtain porous framework thing, put into drying baker (40 ℃ to 75 ℃) dry 6 hours to 48 hours.
7. ceramic powder stock (as hydroxyapatite, tricalcium phosphate) and water are prepared in 10% to 90% ratio, stirred the serosity that formed flow-like in 1 hour to 10 hours.
8. in mould, slurry filling is arrived in the porous framework thing drying at room temperature demoulding in 1 hour to 48 hours and refacing.
9. will pour into dried framework thing and be placed in the sintering furnace, and progressively be warmed up to 200 ℃ to 400 ℃ gasifications and eliminate organic substance, and continue to be warmed up to 800 ℃ to 1800 ℃ subsequently and sinter the individuation biomimetic structure artificial bone that is fit to the different crowd demand into.
In the present invention, the material of making three-dimensional organic network can use polystyrene, polyethylene, polypropylene, polrvinyl chloride, polyamide, polyurethane and polymethyl methacrylate etc.This material does not stay any harmful substance behind high temperature sintering, also not with artificial bone generation chemical reaction.This support can be to have geometrical rule to arrange in length and breadth, also disorderly and unsystematic arrangement.The monofilament cross section of this support can be circle, ellipse, square, triangle and irregular shape etc., 10 microns to 5000 microns of its diameters.
In the present invention, selection can be by the regular and irregular plastic grain of organic solvent and heating for dissolving, preferred plastic grain raw material has polystyrene, polyethylene, polypropylene, polrvinyl chloride, polyamide, polyurethane and polymethyl methacrylate etc., and it does not stay any harmful substance through high-temp combustion.The thermosol point of plastic grain should be at 100 ℃ to 400 ℃.The plastic grain diameter is at 100 microns to 1000 microns.Organic solvent can be selected acetone, diacetone, bromochloromethane, hexone, chloroform etc. for use according to the plastic grain composition.Binding agent should be selected the granule of the bonding above-mentioned raw materials of energy for use.
In the present invention, strengthen body at the inner column compact substance pottery that adds of artificial bone.Each this artificial bone has 1 to 10 to strengthen body, and each strengthens 1 millimeter to 50 millimeters of body diameter, and its cross section is shapes such as circle, ellipse, side, trigonometric sum are irregular.This strengthens the body distribution can vertical, horizontal, oblique and cross arrangement.
In the present invention, mold materials has no particular limits, and can use used solvent is chemically inert material formation, for example rustless steel, pottery, glass, Gypsum Fibrosum etc.This mould must have one or more feeding ports.Mold must become vertically halfbody or multi-section split, involutory very driving fit between the each several part.Facilitate for the demoulding of porous framework thing like this.
In the present invention, there is no particular limitation to used ceramic powders, as long as can satisfy biocompatibility, as pure ha or doped hydroxyapatite, pure phosphoric acid DFP or doping phosphoric acid DFP, pure calcium carbonate or doping calcium carbonate, pure alumina or doped aluminium, pure zirconia or doped zirconia, titanium dioxide, magnesium aluminate spinel etc.Used ceramic powders should be able to mix the formation serosity with water.
In the present invention, pour into the elimination of being gasified of dried framework thing organic substance in the process of progressively heating, its treatment temperature and time are gasified totally to eliminate with organic substance and are as the criterion, and are controlled at usually more than 200 ℃, continue 12 hours to 48 hours.In sintering process, its programming rate, temperature and sintering time should be determined according to used ceramic powder stock, are controlled at usually more than 900 ℃, continue 4 hours to 12 hours.
The reconstruction of three-dimensional anatomical structure image of mentioning in the preparation process of above-mentioned biomimetic structure artificial bone (separate case application) comprising:
(1) CT Image Acquisition:
1, scanning position is the knee joint sagittal plane, and the knee joint near end of thighbone scans several layer data as much as possible; Be used to design determining of the marrow being invaded by pathogen cavity direction;
2, work station download CT initial data is the BMP file format, and bed thickness is chosen for 0.3～0.5mm and is advisable;
(2) Flame Image Process:
Purpose: the profile that had both comprised femur in the CT image, comprise patella, cartilage and other soft tissues again, need take rational image processing techniques that each tomographic image is carried out dividing processing, obtain the clear pattern of femur profile, carry out the vector graphics that binary conversion treatment further obtains the femur profile thereupon.Use Image Manager software processes.
(3) the some cloud is handled
Use surfacer software processes (importing cloud data) with the asc form.
(4) surface reconstruction
Use Surfacer software reconfiguration curved surface.
In view of the complexity of distal femoral surface cloud data, realize simultaneously and the seamless link of common CAD software that the present invention adopts NURBS (non-uniform Rational B-Spline) curve/surface methodology that the three dimensional point cloud of dog femoral is carried out match structure face.Consider the complexity of articular surface, adopt 1. point data to paste and free form surface (fit freeform) 2. point data and boundary curve construction curved surface (fit freeform with cloud ﹠amp the cloud data of articular surface; Boundary curve) structure face mode structure face, because femoral shaft part cloud data is level and smooth relatively, the present invention has adopted traditional LOFT structure face mode.
(5) CAD entity design
After surface reconstruction is finished, the curved surface data of reconstruct in the Surfacer software is converted into the iges file format, carries out femur CAD entity design in the input Unigraphics II software.Be output as Rpdata acceptable stl file and be used for processing.
In sum, press the artificial bone of the biomimetic structure of the above-mentioned preparation method of the present invention, it is characterized in that:
(1) artificial bone of described biomimetic structure can duplicate human body skeleton dissection profile and size fully, be complementary with bone defect repair position, and establish two systems of intercommunity pipeline and micro-system in artificial bone inside, cell and tissue are grown in the material, and can obtain enough nutrition, be formed with the tissue of function;
(2) the inner column compact substance pottery that adds of this artificial bone strengthens body; The intercommunity pipeline is netted;
(3) described artificial bone, each has 1-10 to strengthen body, and each strengthens the body diameter is the 1-5 millimeter, and its cross section is circular, oval, square, triangle or irregularly shaped; Strengthening body distributes and can be in vertical, horizontal, oblique or the cross arrangement any one;
(4) described intercommunity tubing or regular geometric are arranged in length and breadth, are disorderly and unsystematic arrangements; 10 to 5000 microns of this pipe diameters, tubular is circle, ellipse, side, triangle or irregularly shaped, about the pipeline and between left and right apart from 10 to 2000 microns;
(5) described microcirculqtory system is the porous microstructure of intercommunity, is connected 5 to 500 microns in footpath in 100 to 1000 microns of porositys 50% to 90%, aperture and the hole; Hole shape is a kind of in spherical, cube or the irregular shape.
Description of drawings
Fig. 1 is according to right side femoral inferior segment CT scan data, rebuilds left side femoral inferior segment 3 D anatomy structure image in computer;
Fig. 2 is according to the computer reconstruction view data, makes the photo of 3 D anatomy structure model by Rapid Prototyping technique;
Fig. 3 is according to 3 D anatomy structure modelling left side femoral inferior segment biomimetic structure artificial bone photo;
Fig. 4 shows tubing (1) and equally distributed spherical porous structure (2) that rule is arranged in length and breadth for the section micro structure of the biomimetic structure artificial bone of the present invention of observation under the scanning electron microscope.
The specific embodiment
The employing hydroxyapatite is a Ceramic Material, and making length is the biomimetic structure artificial bone of 22 centimetres human body left side femoral inferior segment anatomic form.Be connected 80 microns to 120 microns in footpath in 400 microns to 600 microns of the porositys 65% to 70% of this artificial bone, aperture and the hole.Intercommunity mesh duct system requirements is up and down and between left and right apart from being 2.5 millimeters, and become rule in length and breadth three-dimensional geometry arrange.The circular monofilaments diameter is 250 microns.Concrete steps are as follows:
1) the right side femoral inferior segment carries out CT scan;
2) the CT binaryzation data of Huo Deing are handled and reverse, rebuild left side femoral inferior segment 3-D view;
3) add 15% material shrinkage factor according to this view data, by Rapid Prototyping technique with polymethyl methacrylate (PMMA) material 3 D anatomy structure model;
4) according to the corresponding mould of this mould plaster material;
5) according to the mesh duct systematic parameter of determining, by the Rapid Prototyping technique three-dimensional organic network of PMMA material;
6) metal bar of organic network and 4 millimeters of 4 diameters of being equally spaced is put in the mold cavity, PMMA spheroidal particle with 560 microns to 790 microns of diameters fills up the entire die chamber, filling acetone is until overflowing, wait for that adding the water flushing after 20 minutes removes acetone, the demoulding of porous framework thing and removal metal bar were put into 50 ℃ of dryings of drying baker 14 hours;
7) 600 gram hydroxyapatite powder raw materials and 400 gram water are put into beaker with agitator stirring 2 hours, make it become serosity.
8) in mould with slurry filling in the porous framework thing, drying at room temperature is after 30 hours, the demoulding and refacing.
9) the framework thing after the grouting and drying is placed in the sintering furnace, progressively is warmed up to 200 ℃, keep gasification in 24 hours to eliminate Organic substance, continue to be warmed up to 1200 ℃ subsequently, sintering made it become the biomimetic structure artificial bone of left side hypomere femur form in 8 hours.
Adopting tricalcium phosphate or doping phosphoric acid DFP is Ceramic Material, and making length is the biomimetic structure artificial bone of 15 centimetres human body left side tibia epimere anatomic form.The micro structure of this artificial bone and intercommunity mesh duct system structure are with embodiment 1.Concrete steps only have the difference of Ceramic Material (tricalcium phosphate) and sintering temperature (1100 ℃ continue 6 hours), and other is with embodiment 1.
Embodiment 3
The employing hydroxyapatite is a Ceramic Material, and making length is the biomimetic structure artificial bone of 6 centimetres mandibular bone stage casing, human body right side anatomic form.The micro structure of this artificial bone, intercommunity mesh duct system structure and concrete steps are with embodiment 1.
Embodiment 4
One example suffers from 15 years old patient male of left side distal femur osteogenic sarcoma, in operation, this femoral inferior segment is excised for long 22 centimetres fully, substitute with the biomimetic structure artificial bone that embodiment 1 makes in this bone defect, and add at the joint face and to use metal prostheses, adopt intramedullary pin and plate screw to fix.Two week back patients are can following ground movable, and back X-ray sheet shows new bone formation all around.
Embodiment 5
One example suffers from 26 years old patient male of left side proximal tibia osteochondrosarcoma, in operation, segment length on this tibia is excised for 15 centimetres fully, substitute with the biomimetic structure artificial bone that embodiment 2 makes in this bone defect, and add at the joint face and to use metal prostheses, adopt intramedullary pin and plate screw to fix.
Claims (10)
1, a kind of artificial bone of biomimetic structure, the artificial bone that it is characterized in that described biomimetic structure can duplicate human body skeleton dissection profile and size fully, be complementary with bone defect repair position, and establish two systems of intercommunity pipeline and micro-system in artificial bone inside, cell and tissue are grown in the material, and can obtain enough nutrition, be formed with the tissue of function.
2,, it is characterized in that the inner column compact substance pottery that adds of this artificial bone strengthens body by the artificial bone of the described biomimetic structure of claim 1; The intercommunity pipeline is netted.
3, by the artificial bone of the described biomimetic structure of claim 2, it is characterized in that described artificial bone, each has 1-10 to strengthen body, and each strengthens the body diameter is the 1-5 millimeter, and its cross section is circular, oval, square, triangle or irregularly shaped; Strengthening body distributes and can be in vertical, horizontal, oblique or the cross arrangement any one.
4, biomimetic structure artificial bone according to claim 1 and 2 is characterized in that described intercommunity tubing or regular geometric arrange in length and breadth, is disorderly and unsystematic arrangement; 10 to 5000 microns of this pipe diameters, tubular is circle, ellipse, side, triangle or irregularly shaped, about the pipeline and between left and right apart from 10 to 2000 microns.
5, the artificial bone of biomimetic structure according to claim 1 is characterized in that described microcirculqtory system is the porous microstructure of intercommunity, is connected 5 to 500 microns in footpath in 100 to 1000 microns of porositys 50% to 90%, aperture and the hole; Hole shape is a kind of in spherical, cube or the irregular shape.
6, preparation is characterized in that as the method for the artificial bone of each biomimetic structure in the claim 1 to 5 it may further comprise the steps:
(a) strong side anatomical structure is carried out CT scan, interlamellar spacing is 0.3-0.5mm, with the accuracy that guarantees to rebuild;
(b) the CT binaryzation data that obtain are handled and reverse reconstruction of three-dimensional anatomical structure image;
(c), make the 3 D anatomy structure model by Rapid Prototyping technique, and should make used material shrinkage factor adding amplification coefficient according to artificial bone according to 3 d image data;
(d), make corresponding mould by turning over modeling method according to the 3 D anatomy structure model; Or utilize 3 d image data, directly make mould by program controlled machine tool;
(e) according to the vascularity density and the size data of design, applying fast-forming technology or plastics silk Method for bonding are made three-dimensional organic network;
(f) metal bar of 1 millimeter to 50 millimeters of organic network after at first will pruning and diameter is put in the mold cavity, inserts plastic grain, and filling organic solvent or binding agent or heating are partly dissolved plastic grain; Add water and remove solvent or binding agent or cooling formation porous framework thing.This framework thing demoulding and removal metal bar are put into inherent 40 ℃ to the 75 ℃ scopes of drying baker, dry 6 hours to 48 hours;
(g) Ceramic Material and water are prepared in 10% to 90% ratio, stirred the serosity that formed flow-like in 1 hour to 10 hours;
(h) in mould slurry filling is arrived in the porous framework thing, natural drying is 1 hour to 48 hours under the room temperature, the demoulding and refacing;
(i) will pour into dried framework thing and be placed in the sintering furnace, progressively be warmed up to 200 ℃ to 400 ℃, make the organic substance elimination that is gasified totally; Continue to be warmed up to 800 ℃ to 1800 ℃ subsequently, make it sinter individuation biomimetic structure artificial bone into.
7, by the preparation method of the artificial bone of the described biomimetic structure of claim 6, it is characterized in that described organic network be in polystyrene, polyethylene, polypropylene, polyvinyl chloride, polyamide, polyurethane or the polymethyl acrylate any.
8, press the preparation method of the artificial bone of claim 6 or 7 described biomimetic structures, it is characterized in that
(a) filling plastic grain diameter 100-1000 micron in organic network;
(b) described heat fusion joint be 100-400 ℃ of plastic grain be in polystyrene, polyethylene, polypropylene, polyvinyl chloride, polyamide, polyurethane or the polymethyl acrylate any one;
(c) organic solvent of selecting for use according to the plastic grain composition is a kind of in acetone, diacetone, bromochloromethane, hexone or the chloroform.
9, by the preparation method of the artificial bone of claim 6 or 7 described biomimetic structures, it is characterized in that described Ceramic Material be in hydroxyapatite, adulterated hydroxyapatite, tricalcium phosphate, doping phosphoric acid DFP, calcium carbonate, doping calcium carbonate, aluminium oxide or doped aluminium, zirconium oxide, doped zirconia, titanium dioxide or the magnesium aluminate spinel any one.
10, each described biomimetic structure artificial bone is used for the bone defect repair and dissects the application of structural remodeling in the claim 1 to 5 in orthopaedics, plastic surgery, decorative sursery, department of eye and department of cerebral surgery.
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