Patent ID: 9642937
Date: 2017-05-09
CPC Classifications: A61L

Claim:
1. A preparation method for an implantable medical biological material of animal origin, comprising the following steps: step 1, pre-processing, separating and washing of animal tissue material taking out fresh animal tissue and washing the flesh animal tissue with injection water for 3 times to obtain washed animal tissue; step 2; inactivating virus inactivating the virus in the washed animal tissue obtained in the step 1 by using ethanol solution with a low concentration of peracetic acid to obtain inactivated material; conducting a cleaning step in an oscillation ultrasonic cleaner at a constant temperature; wherein the peracetic acid takes up a percentage of 0.05˜0.2% by volume, an inactivation time ranges from 1 h to 2 hours; wherein the constant temperature ranges from 4° C. to 40° C.; cleaning the inactivated material in a phosphate buffer solution for 2˜5 times; wherein each time the cleaning lasts for 15 minutes; detecting a pH value of the phosphate buffer solution after each time of the cleaning: when a pH value reaches a range from 6.5 to 7.5, cleaning the inactivated material with flow injection water until a conductivity is lower than 1.5 um/s, such that a first cleaned material is obtained; step 3, decellularizing cell wherein the step 3 is conducted in an oscillation sink having an ultrasonic cleaner at a constant temperature; placing the first cleaned material obtained in the step 2 into the oscillation sink; injecting a sodium hydroxide solution into the oscillation sink, and turning on the ultrasonic cleaner; wherein a cleaning time by using the sodium hydroxide solution ranges from 5 to 30 minutes: wherein a concentration of the sodium hydroxide solution ranges from 5 mmol/L to 100 mmol/L; turning off the ultrasonic cleaner; pouring out the sodium hydroxide solution; injecting a phosphate buffer solution into the ultrasonic cleaner and turning on the ultrasonic cleaner; wherein a cleaning time by using the phosphate buffer solution ranges from 5 minutes to 20 minutes; repeating the cleaning with the sodium hydroxide solution for 2˜5 times to obtain a second cleaned material; detecting a pH value of the phosphate buffer solution after each time of the cleaning; cleaning the second cleaned material by using a flowing injection water when the pH value of the phosphate buffer solution is in a range from 6.5 to 7.5; terminating the cleaning until a conductivity is lower than 1.5 um/s; step 4, sodium chloride treating wherein the step 4 is conducted in the oscillation sink having the ultrasonic cleaner at a constant temperature; injecting a sodium chloride solution into the oscillation sink, and turning on the ultrasonic cleaner to obtain a third cleaned material; wherein a cleaning time by using the sodium chloride solution ranges from 5-30 minutes; wherein a concentration of the sodium chloride solution is 0.015 mol/L or 2 mol/L, and a pH value of the sodium chloride solution is less than 7.8; washing the third cleaned material with the flowing injection water until a conductivity is lower than 1.5 um/s, such that a fourth cleaned material is obtained; step 5, molding step fixing the fourth cleaned material obtained in the step 4 to a plurality of devices, freezing and drying the fourth cleaned material, and drilling a plurality of micro holes on the fourth cleaned material using a laser; wherein sizes and shapes of the plurality of devices vary in accordance with different product requirements; securing the fourth cleaned material onto the plurality of devices and washing the fourth cleaned material by flowing injected water, such that a washed material is obtained; placing the washed material into a freeze drying machine and securing; performing a pre-designed lyophilization process to obtain a lyophilized material; wherein the pre-designed lyophilization process includes drilling a plurality of micro holes on the lyophilized material using a laser such that a drilled material is obtained: wherein a diameter of each of the plurality of micro holes of the drilled material ranges from 0.05 to 1 mm; wherein a distance between adjacent micro holes ranges from 0.1 cm to 2 cm: step 6, packaging sterilization performing a packaging step in a sterile condition; wherein a first layer of a packaging is a tyvek paper, a second layer of the packaging is a polyethylene plastic layer; performing an ethylene oxide sterilization after the packaging step.