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Composite material used for interbody fusion cage and its preparation method

An intervertebral cage and composite material technology, which is applied in the field of composite materials and preparation of absorbable intervertebral cages, can solve the problems of lack of osteogenic activity, insufficient material crystallinity, and poor strength of the cage, and achieve good bone quality. Induced activity, simple preparation method, and good interfacial bonding effect

Active Publication Date: 2012-01-18
ZHEJIANG APELOA JIAYUAN BIOMEDICAL MATERIAL +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Chinese Patent Publication Nos. CN1436518A and CN2561364A respectively announced the development process of cages made of polylactic acid or added hydroxyapatite as materials, but their strength and degradation performance need to be further improved, and the cages lack osteogenic activity.
However, the product still has the disadvantages of unstable mechanical properties, poor bone conduction ability, and inappropriate degradation rate.
Chinese Patent Publication No. CN101450015A relates to an intervertebral cage made of polylactic acid / glycolic acid copolymer PLGA and hydroxyapatite, but the mass ratio of LA and GA in PLGA is 50:50 to 90:10, and the added Hydroxyapatite is only nanoparticles, and the added content is 5-20%. In addition, its fusion vessel processing method is limited to the fluidized bed tablet method; meanwhile, because the LA content in PLGA is not very high (less than 90%), The crystallinity of the overall material is not high enough, resulting in its strength not as good as PLLA homopolymer
At present, PLGA with a high content of LA monomer (greater than 90%) is used as a matrix, and the literature and patents of adding a high content of HA to make a fusion device have not been reported.

Method used

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  • Composite material used for interbody fusion cage and its preparation method
  • Composite material used for interbody fusion cage and its preparation method
  • Composite material used for interbody fusion cage and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] L-PLGA (the molar ratio of LA / GA is 98 / 2) polymer molecular weight is 350,000, accounts for 95% by weight of finished product, is dissolved in methylene chloride, and concentration is 5g / 100ml; Mixed solvent with dichloromethane (volume ratio: 1:1) was ultrasonically dispersed to form a suspension, and then filtered with 0.22um filter paper. The HA content is measured at 5% of the weight of the finished product, and the L-PLGA solution and the HA solution are mixed under ultrasonic stirring, and the above-mentioned compound solution is continued to be ultrasonically stirred for 2 hours, then precipitated with excess absolute ethanol, left to stand and filtered, and washed with absolute ethanol Washed 3 times and dried in vacuum to obtain L-PLGA / HA composite material.

[0025] The intervertebral fusion cage was made by molding with an injection machine at an injection temperature of 190°C. The intervertebral fusion cage is a hollow cylinder with a quadrangular or hexago...

Embodiment 2

[0027] L-PLGA (the molar ratio of LA / GA is 95 / 5) polymer molecular weight is 320,000, accounts for 70% by weight of finished product, is dissolved in methylene chloride, and concentration is 8g / 100ml; The mixed solvent of dichloromethane (volume ratio is 2: 1) is ultrasonically dispersed into a suspension, filtered with 5um filter paper, and the HA content is 30% based on the weight of the finished product, and added to the dichloromethane solution of L-PLGA under ultrasonic stirring , continue to ultrasonically stir the above composite solution for 3 hours, precipitate with excess absolute ethanol in the above composite solution, stand and filter, wash with absolute ethanol 3 times, and vacuum dry to obtain the L-PLGA / HA composite material.

[0028] Molding by injection machine, injection temperature is 200 ℃, to make intervertebral fusion device. After testing, the finished product has a compression resistance of 11440N and an elastic modulus of 4.9GPa, see Table 1.

Embodiment 3

[0030]L-PLGA (the molar ratio of LA / GA is 92 / 8) polymer molecular weight is 320,000, and HA content accounts for 50% by weight of finished product, is dissolved in methylene chloride, and concentration is 10g / 100ml; The HA whisker After ultrasonically dispersing into a suspension with a mixed solvent of ethanol and dichloromethane (volume ratio is 5:3), filter with 20um filter paper, account for 50% by weight of the finished product, add the dichloromethane solution of L-PLGA under ultrasonic stirring In the process, the above composite solution was continued to be ultrasonically stirred for 4 hours, precipitated with excess petroleum ether in the above composite solution, left to filter, washed 3 times with absolute ethanol, and vacuum-dried to obtain the L-PLGA / HA composite material.

[0031] The intervertebral fusion cage was made by molding with an injection machine at an injection temperature of 210°C. After testing, the finished product has a compression resistance of 10...

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Abstract

The invention discloses a composite material used for an interbody fusion cage and its preparation method. The composite material comprises by weight: 50-98% of poly(L-lactic acid-co-glycolic acid) (L-PLGA), and 2-50% of hydroxyapatite (HA). With high strength and good osteoinductive activity, the fusion cage of the invention can be fully degraded and absorbed in vivo, thus being a new generation of absorbable interbody fusion cage which is of high strength and high bone fusion rate and can meet clinical application requirements.

Description

technical field [0001] The invention belongs to the technical field of medical material manufacturing, and in particular relates to a high-strength bioactive absorbable intervertebral fusion device composite material and a preparation method. Background technique [0002] The intervertebral disc herniation and intervertebral instability caused by spinal degeneration are common and frequently-occurring diseases that plague human beings in today's society. After intervertebral disc herniation, it often causes instability between the vertebral bodies or narrowing of the intervertebral space. The intervertebral disc herniation compresses the nerves and causes long-term pain, which seriously affects the work and life of the patient. Over time, spondylolisthesis may occur , and even more serious consequences such as paralysis. Patients who do not respond to conservative treatment usually require intervertebral fusion surgery. Autologous bone grafting is the gold standard for spi...

Claims

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Application Information

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IPC IPC(8): A61L31/12
Inventor 庞秀炳蒋柳云李庆齐雪飞周伟吴侃熊成东
Owner ZHEJIANG APELOA JIAYUAN BIOMEDICAL MATERIAL
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