CN110981459A - High-strength degradable hollow bar and manufacturing method thereof - Google Patents

High-strength degradable hollow bar and manufacturing method thereof Download PDF

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CN110981459A
CN110981459A CN201911169959.7A CN201911169959A CN110981459A CN 110981459 A CN110981459 A CN 110981459A CN 201911169959 A CN201911169959 A CN 201911169959A CN 110981459 A CN110981459 A CN 110981459A
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hollow bar
strength degradable
rod
bar
manufacturing
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CN110981459B (en
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邵惠锋
贺永
傅建中
龚友平
刘海强
陈慧鹏
李文欣
陈国金
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Hangzhou Dianzi University
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    • C04B35/00—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products
    • C04B35/01—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics
    • C04B35/16—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics based on silicates other than clay
    • C04B35/22—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics based on silicates other than clay rich in calcium oxide, e.g. wollastonite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary pins, nails or other devices
    • C—CHEMISTRY; METALLURGY
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    • C04B35/00—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products
    • C04B35/622—Forming processes; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products
    • C—CHEMISTRY; METALLURGY
    • C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
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    • C04B35/00—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products
    • C04B35/622—Forming processes; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products
    • C04B35/626—Preparing or treating the powders individually or as batches ; preparing or treating macroscopic reinforcing agents for ceramic products, e.g. fibres; mechanical aspects section B
    • C04B35/62605—Treating the starting powders individually or as mixtures
    • C04B35/62625—Wet mixtures
    • C04B35/6264—Mixing media, e.g. organic solvents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526—Methods of manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
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    • C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B2235/00—Aspects relating to ceramic starting mixtures or sintered ceramic products
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    • C04B2235/3427—Silicates other than clay, e.g. water glass
    • C04B2235/3436—Alkaline earth metal silicates, e.g. barium silicate
    • C04B2235/3445—Magnesium silicates, e.g. forsterite
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    • C04B2235/00—Aspects relating to ceramic starting mixtures or sintered ceramic products
    • C04B2235/60—Aspects relating to the preparation, properties or mechanical treatment of green bodies or pre-forms
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    • C04B2235/6022—Injection moulding

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Abstract

The invention discloses a high-strength degradable hollow bar and a manufacturing method thereof, wherein the bar is prepared by adopting calcium magnesium silicate through biological ink preparation, freeze drying and shaping and high-temperature sintering, the manufactured hollow bar has high mechanical strength, is straight, has a uniform cross section, is lighter than a conventional solid bar, can be continuously absorbed in vivo, and is beneficial to bone conduction due to the generation of a phosphate layer in the absorption and degradation process. The manufacturing method of the high-strength degradable hollow bar is convenient to operate and low in manufacturing cost, and can be used for randomly changing the diameter of the bar and manufacturing hollow bars with different diameters.

Description

High-strength degradable hollow bar and manufacturing method thereof
Technical Field
The invention relates to an apparatus in the technical field of medical apparatus and instruments and a manufacturing method thereof, in particular to a high-strength degradable hollow bar and a manufacturing method thereof.
Background
With the development of social economy and the improvement of social level, people pay more and more attention to their medical health career, and new medical instruments are continuously developed. With the aging population, the number of fracture cases caused by bone weakness of the elderly increases year by year, and the number of fracture cases caused by accidents increases day by day. Bone nail, bone stick, intramedullary nail and other orthopedic materials are all indispensable medical instrument in the orthopedic operation, and wherein the intramedullary nail is fixed to central axial bone nail, and is more stable, can greatly reduced outer periosteum and blood circulation destruction degree. Intramedullary nails are commonly used for straight fractures and fractures with slight radian, and have good treatment effect in clinical application.
Intramedullary nails currently in clinical use are mainly made of stainless steel, titanium alloys. The elasticity modulus of the alloy is far higher than that of human bones, the mechanical strength is high, the stress shielding effect can be generated while the bone healing is assisted, the effective stress stimulation cannot be obtained on fracture parts, and finally the fracture healing effect is poor or even fails. Meanwhile, after the implant is implanted into a human body, toxic ions or particles can be slowly released, chronic inflammation is caused, and the implant is not easy to cure. Moreover, in the repair process after the intramedullary nail fixation operation, the operation of taking out the locking nail and the operation of taking out all the parts after healing are required, thereby increasing the economic burden and the pain of the patient. The absorbable intramedullary nail adopted in recent years can solve the problems of alloy nails to a certain extent, but the existing clinical absorbable instrument is basically made of polymer materials, such as polylactic acid, polyvinyl alcohol, chitosan and the like, and has low strength and difficult meeting the requirements on mechanical properties, and acidic substances generated in the absorption process can also cause rejection reaction.
Therefore, there is a need to create a high strength degradable intramedullary nail implant that gradually disintegrates in the body as the bone heals, does not require surgical removal, is non-toxic, has high mechanical strength and good bioactivity, and promotes bone healing.
Disclosure of Invention
Aiming at the defects in the prior art, the invention provides a high-strength degradable hollow bar and a manufacturing method thereof.
In order to achieve the purpose, the technical scheme adopted by the invention is as follows:
a high-strength degradable hollow bar is straight, uniform in cross section and hollow inside and is made of a bioactive material; the bioactive material is calcium magnesium silicate, and the mass percentage of magnesium in the calcium magnesium silicate is 0.22-3.2%. When calcium silicate powder is prepared by a chemical precipitation method, a certain amount of magnesium ion aqueous solution is added in proportion, and magnesium is used for replacing calcium, so that calcium-magnesium silicate is finally obtained.
Preferably, the high-strength degradable hollow bar is provided with holes, the diameter of each hole is 1 mm-10 mm, and the number of the holes can be 2, 4 or more. The holes may be perpendicular to the axis of the rod or may be angled.
Preferably, one end of the high-strength degradable hollow bar is provided with a straight groove, and the number of the grooves can be one or 2.
Preferably, the inner diameter of the high-strength degradable hollow bar is 1/10-2/5 of the outer diameter.
Preferably, the present invention relates to a method for manufacturing the high-strength degradable hollow bar, comprising the steps of:
1) and uniformly mixing the biological material with the solvent to obtain the uniformly dispersed biological ink.
2) And calculating the inner diameter and the outer diameter of the blank rod according to the shrinkage rate of the material, and customizing corresponding inner rod, outer rod and end cover.
3) Assembling the inner rod, the outer rod and the end cover together to form a mould, injecting the bio-ink obtained in the step 1) into the mould, and freezing for 2-12 hours.
4) And (4) freezing and drying the frozen sample to obtain a hollow bar blank.
5) And (3) placing the hollow bar blank into a high-temperature furnace for high-temperature calcination, and finally cooling to obtain the high-strength degradable hollow bar.
Preferably, the solvent is a combination of a binder, a dispersing agent, a defoaming agent and deionized water, the binder can be polyvinyl alcohol, carboxymethyl cellulose and the like, the dispersing agent can be polyacrylic acid, and the defoaming agent can be Surfynol.
Further, the concentration of polyvinyl alcohol is 5% -15%, the concentration of carboxymethyl cellulose is 0.5% -5%, the mass percentage of all materials in the biological ink is 50% -60% of biological materials, 1% -4% of binders, 0.3% -0.9% of dispersing agents and 0.3% -0.9% of defoaming agents, and the balance is deionized water.
Preferably, the end cover is tightly matched with the inner rod and the outer rod, and one or 2 convex linear protrusions are arranged on one side, close to the outer rod, of the end cover.
Furthermore, the end cover inside have 2 parallel panels, be the through-hole in the middle of the panel, interior stick and end cover cooperation back, through the design of two through-holes on the end cover for interior stick is parallel with outer stick.
Preferably, the outer rod is a hollow rod, the inner wall of the outer rod and the outer wall of the inner rod are both smooth, and after the sample is freeze-dried, the biological ink can be separated from the outer rod and the inner rod, and the biological ink can be a glass tube, a quartz tube and the like.
Further, the wall thickness of the outer rod is 1-4 mm.
Furthermore, the diameter of the blank of the hollow bar can be directly changed by changing the inner diameter of the outer rod and the outer diameter of the inner rod, thereby affecting the size of the final hollow bar, and the sizes of the outer rod and the inner rod can be easily changed, so that hollow bars of any size can be easily manufactured.
Preferably, the freezing process is quick freezing, and the quick freezing temperature is 70 ℃ below zerooC-80oAnd C, rapidly shaping the biological ink, and then freeze-drying to obtain a dried biological ink hollow bar blank.
Preferably, the calcination temperature is 1150oC-1200oC, the temperature rising speed is 2 to 3oC/min, and the heat preservation time is 2-4 hours.
Compared with the prior art, the invention has the following advantages:
the invention can manufacture high-strength bioactive degradable hollow bars, makes up the defects of degradable polymer materials, and has good straightness and uniform section.
Secondly, the method for manufacturing the high-strength degradable hollow bar is convenient to operate and low in manufacturing cost.
Thirdly, the high-strength degradable hollow bar material manufactured by the invention can be continuously absorbed in vivo, and a phosphate layer is generated in the absorption and degradation process, thereby being beneficial to bone conduction.
The degradable hollow bar manufactured by the invention has high mechanical strength, and is lighter and more material-saving than a solid bar.
Drawings
FIG. 1 is a schematic flow chart of the manufacturing method of the high-strength degradable hollow bar material of the invention;
FIG. 2 is a schematic structural view of a high-strength degradable hollow bar of the present invention;
FIG. 3 is a schematic cross-sectional view of a high strength degradable hollow rod of the present invention;
FIG. 4 is a schematic view of the combined structure of the outer rod, the inner rod and the end cap of the present invention;
FIG. 5 is a top view of the outer rod, inner rod and end cap combination of the present invention;
FIG. 6 is a schematic view of the end cap construction of the present invention;
FIG. 7 is a cross-sectional view of the end cap of the present invention;
FIG. 8 is a schematic view of the combined structure of the outer rod, the inner rod, the end cap and the lock hole rod of the present invention;
wherein: 1 is an end cover, 2 is an outer rod, 3 is an inner rod, 4 is a convex block, 5 is a through hole, and 6 is a lockhole rod.
Detailed Description
The following examples are given for the detailed implementation and specific operation of the present invention, but the scope of the present invention is not limited to the following examples.
As shown in figures 2 and 3, the high-strength degradable hollow bar is straight, uniform in cross section and hollow inside, and is made of a bioactive material, wherein the bioactive material is calcium magnesium silicate, and the mass percentage of magnesium in the calcium magnesium silicate is 0.22-3.2%. When calcium silicate powder is prepared by a chemical precipitation method, a certain amount of magnesium ion aqueous solution is added in proportion, and magnesium is used for replacing calcium, so that calcium-magnesium silicate is finally obtained.
Be equipped with the hole on the hollow rod of high strength degradable, the diameter of this hole is 1mm ~10mm, can be 2, 4 or more. The holes may be perpendicular to the axis of the rod or may be angled.
One end of the high-strength degradable hollow bar is provided with a straight groove which can be one or 2.
The inner diameter of the high-strength degradable hollow bar is 1/10-2/5 of the outer diameter.
As shown in fig. 1, the method for manufacturing a high-strength degradable hollow bar according to the present invention comprises the following steps:
1) and uniformly mixing the biological material with the solvent to obtain the uniformly dispersed biological ink.
2) And calculating the inner diameter and the outer diameter of the blank rod according to the shrinkage rate of the material, and customizing corresponding inner rod, outer rod and end cover.
3) Assembling the inner rod, the outer rod and the end cap together into a mold, as shown in fig. 4 and 5, injecting the bio-ink of step 1) into the mold, and then freezing for 2-12 hours.
4) And (4) freezing and drying the frozen sample to obtain a hollow bar blank.
5) And (3) placing the hollow bar blank into a high-temperature furnace for high-temperature calcination, and finally cooling to obtain the high-strength degradable hollow bar.
The solvent is a combination of a binder, a dispersing agent, a defoaming agent and deionized water, the binder can be polyvinyl alcohol, carboxymethyl cellulose and the like, the dispersing agent can be polyacrylic acid, and the defoaming agent can be Surfynol. The bio-ink comprises, by mass, 5-15% of polyvinyl alcohol, 0.5-5% of carboxymethyl cellulose, 50-60% of a biological material, 1-4% of a binder, 0.3-0.9% of a dispersant, 0.3-0.9% of an antifoaming agent and the balance deionized water.
The end caps are fitted tightly to the inner and outer bars, and as shown in fig. 6 and 7, have a raised line shape, which may be one, or 2. The end cover is internally provided with 2 parallel panels, a through hole is formed in the middle of each panel, and after the inner rod is matched with the end cover, the inner rod is parallel to the outer rod through the design of the two through holes in the end cover.
The outer stick is hollow stick, and the inner wall of outer stick and the outer wall of interior stick are all smooth, and sample freeze-drying finishes the back, can make biological ink and outer stick and interior stick separation, can be glass pipe, quartz capsule etc..
Furthermore, the wall thickness of the outer rod is 1-4 mm.
Furthermore, the diameter of the blank of the hollow bar can be directly changed by changing the inner diameter of the outer rod and the outer diameter of the inner rod, thereby affecting the size of the final hollow bar, and the sizes of the outer rod and the inner rod can be easily changed, so that hollow bars of any size can be easily manufactured.
The freezing process is quick freezing at-70 deg.CoC-80oAnd C, rapidly shaping the biological ink, and then freeze-drying to obtain a dried biological ink hollow bar blank.
Calcination temperature of 1150oC-1200oC, the temperature rising speed is 2 to 3oC/min, and the heat preservation time is 2-4 hours.
Example 1
1) The calcium magnesium silicate powder with the magnesium content of 1.5 percent, the polyvinyl alcohol of 2.4 percent, the polyacrylic acid of 0.5 percent, the Surfynol of 0.5 percent and the deionized water of 38.6 percent are prepared into the uniform biological ink according to the mass percentage.
2) According to the shrinkage rate of the calcium-magnesium silicate bio-ink, an inner rod with the diameter of 5mm, an outer rod with the inner diameter of 12.7mm and the wall thickness of 3mm and an end cover matched with the outer rod and the inner rod are customized.
3) Combining the inner rod, the outer rod and the end cover together, and then injecting the biological ink prepared in the step 1) into a combined die at-70 DEGoAnd C, quick freezing for 6 hours in the environment.
4) And (3) freeze-drying the sample subjected to quick freezing in the step 3), and taking out the hollow rod blank from the combined die.
5) The hollow bar blank is placed in a high temperature furnace via 1150oAnd C, calcining at high temperature for 3 hours, and cooling to obtain the high-strength degradable calcium-magnesium silicate hollow bar with the outer diameter of 10mm, the inner diameter of 4mm and the length of 90 mm.
Example 2
1) The calcium magnesium silicate powder with the magnesium content of 1.8 percent, the carboxymethyl cellulose of 0.5 percent, the polyacrylic acid of 0.5 percent, the Surfynol of 0.5 percent and the deionized water of 43.5 percent are prepared into the uniform biological ink according to the mass percentage.
2) According to the shrinkage rate of the calcium-magnesium silicate bio-ink, an inner rod with the diameter of 5.2mm, an outer rod with the inner diameter of 13.1mm and the wall thickness of 3mm and an end cover matched with the outer rod and the inner rod are customized.
3) Combining the inner rod, the outer rod and the end cover together, and then injecting the biological ink prepared in the step 1) into a combined die at-70 DEGoAnd C, quick freezing for 6 hours in the environment.
4) Freeze-drying the sample after quick freezing in the step 3), and taking out the blank of the hollow rod from the combined die;
5) the hollow bar blank is placed in a high temperature furnace via 1150oAnd C, calcining at high temperature for 3 hours, and cooling to obtain the high-strength degradable calcium-magnesium silicate hollow bar with the outer diameter of 10mm, the inner diameter of 4mm and the length of 90 mm.
Example 3
1) Preparing uniform biological ink by 58 mass percent of calcium magnesium silicate powder with the magnesium content of 1.5 percent, 2.4 mass percent of polyvinyl alcohol, 0.5 mass percent of polyacrylic acid, 0.5 mass percent of Surfynol and 38.6 mass percent of deionized water;
2) according to the shrinkage rate of the calcium-magnesium silicate biological ink, an inner rod with the diameter of 5mm, an outer rod with the inner diameter of 12.7mm and the wall thickness of 3mm, end covers matched with the outer rod and the inner rod, a through hole on the outer rod, and a lock hole rod matched with the outer rod are customized.
3) As shown in fig. 8, the inner rod, the outer rod, the end cap and the keyhole rod are combined together, and then the bio-ink prepared in the step 1) is injected into the combined mould at-80 DEGoAnd C, quick freezing for 8 hours in the environment.
4) And (3) freeze-drying the sample subjected to quick freezing in the step 3), and taking out the hollow rod blank from the combined die.
5) The hollow bar blank is placed in a high temperature furnace via 1150oAnd C, calcining at high temperature for 3 hours, and cooling to obtain the high-strength degradable calcium-magnesium silicate hollow bar with the outer diameter of 10mm, the inner diameter of 4mm and the length of 90 mm.
The bar prepared by the embodiment has high mechanical strength, round section, straight bar, no bending, degradability in vivo and good bioactivity.

Claims (10)

1. The high-strength degradable hollow bar is characterized in that the bar is straight, uniform in cross section and hollow inside, and is made of a bioactive material, wherein the bioactive material is calcium magnesium silicate, and the mass percentage of magnesium in the calcium magnesium silicate is 0.22-3.2%.
2. The high-strength degradable hollow bar of claim 1, wherein the high-strength degradable hollow bar has holes with a diameter of 1mm to 10mm, and the number of the holes is two or four.
3. The high strength degradable hollow bar of claim 1 wherein one end of the high strength degradable hollow bar is provided with a straight groove, and one or two of the straight grooves are provided.
4. The high-strength degradable hollow bar of claim 1, wherein the inner diameter of the high-strength degradable hollow bar is 1/10-2/5 of the outer diameter.
5. A method of manufacturing the high strength degradable hollow bar of claim 1 comprising the steps of:
1) uniformly mixing the biological material with a solvent to obtain uniformly dispersed biological ink;
2) calculating the inner diameter and the outer diameter of the blank rod according to the shrinkage rate of the material, and customizing corresponding inner rod, outer rod and end cover;
3) assembling the inner rod, the outer rod and the end cover together to form a mould, injecting the bio-ink obtained in the step 1) into the mould, and then freezing for 2-12 hours;
4) freezing and drying the frozen sample to obtain a hollow bar blank;
5) and (3) placing the hollow bar blank into a high-temperature furnace for high-temperature calcination, and finally cooling to obtain the high-strength degradable hollow bar.
6. The method of claim 5, wherein the solvent is a combination of a binder, a dispersant, a defoaming agent and deionized water, the binder is polyvinyl alcohol or carboxymethyl cellulose, the dispersant is polyacrylic acid, and the defoaming agent is Surfynol.
7. The method of claim 5, wherein the end cap is tightly fitted to the inner rod and the outer rod, the end cap has a protruding linear protrusion, one or two linear protrusions are provided on the end cap, two parallel panels are provided inside the end cap, and a through hole is provided in the middle of the panels.
8. The method for manufacturing the high-strength degradable hollow bar according to claim 5, wherein the freezing is quick freezing, and the quick freezing temperature is 70 ℃ below zerooC-80oC。
9. The method for manufacturing a high-strength degradable hollow bar according to claim 5, wherein the calcination temperature is 1150%oC-1200oC, literThe temperature and speed is 2-3oC/min, and the heat preservation time is 2-4 hours.
10. The method for manufacturing a high-strength degradable hollow bar according to claim 5, wherein the wall thickness of the outer bar is 1-4 mm.
CN201911169959.7A 2019-11-26 2019-11-26 High-strength degradable hollow bar and manufacturing method thereof Active CN110981459B (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105194728A (en) * 2015-10-12 2015-12-30 浙江大学 Degradable bioactive porous ceramic material, preparation method and application of degradable bioactive porous ceramic material
CN106348785A (en) * 2015-07-21 2017-01-25 浙江大学 Bioactive porous ceramic tubular bar material as well as preparation method and application thereof

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106348785A (en) * 2015-07-21 2017-01-25 浙江大学 Bioactive porous ceramic tubular bar material as well as preparation method and application thereof
CN105194728A (en) * 2015-10-12 2015-12-30 浙江大学 Degradable bioactive porous ceramic material, preparation method and application of degradable bioactive porous ceramic material

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
赵康等: "冷冻干燥法制备羟基磷灰石多孔支架", 《硅酸盐学报》 *

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