Preparation method for implantable medical biological materials of animal origin

A preparation method for an implantable medical biological material of animal origin, characterized in comprising the following steps:

• 1) pre-processing, separating and washing of a plurality of animal tissue materials
• taking out fresh animal tissue and washing the animal tissue with injection water for 3 times;
• 2) inactivating virus
• inactivating the virus by using ethanol solution with a low concentration of peracetic acid;
• a cleaning step is conducted in an oscillation ultrasonic cleaners with a constant temperature;
• wherein the peracetic acid takes up a percentage of 0.05˜0.2% by volume and an inactivation time ranges from 1 h˜2 h;
• wherein the constant temperature ranges from 4° C. to 40° C.;
• then cleaning the inactivated materials in a phosphate buffer solution for 2˜5 times, wherein each of the cleaning time is 15 minutes;
• detecting a pH value of the phosphate buffer solution after the cleaning;
• when a pH value reaches a range from 6.5 to 7.5, cleaning the material with flow injection water until a conductivity is lower than 1.5 um/s;
• 3) decellularizing cell
• this step is conducted in an oscillation sink having a ultrasonic cleaners with a constant temperature;
• placing above materials into the oscillation sink, and then injecting a sodium hydroxide solution into the oscillation sink, and turning on the cleaners;
• wherein a cleaning time ranges from 5 to 30 minutes;
• the concentration of the sodium hydroxide solution ranges from 5 mmol/L to 100 mmol/L;
• turning off the cleaners and pouring out the sodium hydroxide solution;
• injecting a phosphate buffer solution into the cleaner and turning on the cleaner;
• a cleaning time ranges from 5 minutes to 20 minutes, repeating the cleaning with the sodium hydroxide solution for 2˜5 times;
• detecting a pH value of the phosphate buffer solution after cleaning;
• cleaning above material by using a flowing injection water when the pH value of the detected 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;
• 4) sodium chloride treating
• this step is conducted in the oscillation sink having an ultrasonic cleaners with a constant temperature;
• injecting a sodium chloride solution into the oscillation sink, and turning on the cleaners;
• wherein the cleaning time ranges from 5-30 minutes;
• wherein the concentration of the sodium chloride solution is 0.015 mol/L or 2 mol/L, the pH value is less than 7.8;
• then washing above materials with the flowing injection water until a conductivity is lower than 1.5 um/s;
• 5) molding step
• this step further comprises the following three steps:
• fastening a plurality of devices, freezing and drying, and drilling a plurality of micro holes using a laser;
• wherein sizes and shapes of the plurality of devices vary in accordance with different product requirements:
• securing above materials onto the plurality of device and washing by flowing injected water;
• placing above washed materials into a freeze drying machine and securing;
• performing a lyophilization process as pre-designed;
• wherein the pre-designed lyophilization process is:
• pre-cooling the material to −25˜−50° C. and conducting a heat conservation for 0.5˜4 hours;
• rising a temperature of 15° C. and conducting a heat conservation for 4˜12 hours;
• rising a temperature of 15° C. and conserving for 0.5˜4 hours;
• rising to 25° C. and conserving for 4 hours;
• drilling a plurality of micro holes on above material using a laser after the lyophilization;
• wherein the aperture of a drilled material ranges from 0.05 to 1 mm;
• wherein the distance between the adjacent drilled holes ranges from 0.1 cm to 2 cm;
• 6) packaging sterilization
• a packaging step is performed in a sterile condition;
• wherein one layer of the packaging is a tyvek paper, the other layer is a polyethylene plastic layer;
• an ethylene oxide sterilization is performed after the packaging step.