The skull, as the protective shield of the human brain, assumes the most important responsibility for life activities. According to the statistics, there are more than 3 million patients with cranial defects due to traffic accidents and accidents every year, and cranial defects are the more common sequelae of post-injury and post-operative patients with craniosynostosis. As the brain tissue loses the shielding role of normal skull and is easily injured twice, and the skull defect can cause various symptoms and affect the appearance, it is often necessary to perform skull repair and shaping to restore the normal stable state of intracranial pressure as soon as possible and reduce the continuous severe damage and functional effects on the brain due to the daily drastic changes of brain pressure caused by the skull defect. How to make the patient’s defective skull bone get the maximum repair is the focus of clinical translational medicine research of Tsinghua University Medical Center and Department of Materials for many years.
Products have been approved by Chinese and US FDA
The bionic bone material with the same composition and nanostructure as natural human bone, researched by the Materials Department of Tsinghua University, is the most ideal material for human cranial bone repair at present. After years of systematic research with the most advanced electron microscope in the world, the Department of Materials of Tsinghua University finally discovered the complex and orderly hierarchical structure of natural bone, unveiled the mystery of bone formation and deciphered the “code” of human bone assembly structure. Through the orderly mineralization of collagen with nano-sized hydroxyapatite crystals, we have synthesized a bionic bone that is closest to human bone outside the human body, and connected the bionic bone to the autologous bone seamlessly, which is the first of its kind in the world. This technology not only won several 863 projects in China, but also won the second prize of National Technical Invention in 2008, the second prize of National Natural Science in 2011 (the first prize is vacant), four Chinese invention patents and one US invention patent. The internationally renowned journal “Nature Materials” also gave the product high praise. It is the only product among China’s Class III implants to receive such an award, and it has become a key product project supported by the state because of its fully independent intellectual property rights technology. It has been successfully approved by the Chinese and US FDA.
Tsinghua high-tech material benefits many pediatric patients
The use of titanium mesh for skull repair in China is relatively mature, but it can mostly only be used on adults and is not suitable for children. Because children’s skull is growing, using titanium mesh instead of skull, titanium mesh cannot expand with the growth of skull, which often causes skull deformation and limits brain development in children. As the skull and brain are in the growth and development stage during childhood, the skull defect left after surgery will gradually change with growth and development, so most doctors believe that it is appropriate to repair skull defects in children when they become adults, or to wait until the skull of children over 12 years old is close to that of adults. For example, children within 3~5 years old, if they unfortunately have skull defects, they usually have to wait for up to 7~9 years to catch up with the suitable treatment period for surgery. 7~9 years, the child’s skull already has defects, but because of the lack of timely repair will not only affect the functional recovery, such as poor limb function, strabismus, facial palsy, dizziness, ataxia, etc., which is medically called “decompression window syndrome”, and the loss of cranial protection increases the possibility of directly endangering the child’s life in the event of an external injury. And below the scalp is the fragile brain tissue, just like a house with less solid roof and only a layer of cloth, which is very dangerous, and a little shock may damage the brain tissue. Our new bionic bone material has excellent biocompatibility, no rejection reaction, no thermal conductivity, no influence on nuclear magnetic examination, and the bionic bone can fuse and grow with the skull at the edge of the defect without affecting the growth and development of children’s skull and brain, which is the most ideal material for children’s skull repair and fills the gap in this field in China.
New thinking of clinical surgery leads integrated innovation
Based on a large number of clinical cases practice, we summarized the “Tsinghua University Cranial Repair Surgery Plan”, patients and families can do the best choice according to age, defect size, defect site, overall condition and family economic status, etc.
1.Program 1: Titanium mesh
Advantages: thin plates, light texture, high hardness, and low price.
Disadvantages: children’s cranium is in the developmental stage, the cranium will continue to grow and change, metal materials can not fuse with their own tissue growth, will cause cranial asymmetry affect the beauty, limit brain development, produce deformity is not suitable for children; metal materials, sieve-like, thin thickness, can not rebuild the normal cranial plate barrier and the inner plate, for cranial incomplete repair, and direct contact with brain tissue, to the external cold, heat, electricity, sound, magnetic changes, brain protection is not good. It is sensitive to external cold, heat, electricity, sound and magnetic changes, and the brain protection is not good.
2.Program 2: Bionic material skull repair
Advantages.
Same thickness as own skull, excellent strength and toughness, can resist certain external force and noise impact.
Good histocompatibility, no allergen, no human rejection.
Poor cold and heat conductivity, close to human cortical bone, no stimulation to brain tissue.
non-electromagnetic conductivity, inert material, does not affect X-ray and MRI examinations
can fuse and grow with the edge of human own skull defect, more suitable for pediatric patients
3D shaping and printing according to the doctor’s requirements, also can be trimmed at will during the operation, easy to install.
3.Titanium mesh + bionic material inner plate
Advantages.
Increase the growth of autologous osteoblasts in the repair of the defect and increase the thickness to strengthen the brain protection against external hot and cold sun.
Double protection of human brain, especially suitable for adult patients with large skull defects.
With the best resistance to external impact, heat, cold, electromagnetic intense sun radiation and strong acoustic shock.
4.The ultimate perfect repair solution
Advantages.
Extra-mud shaping of artificial bone (cosmetic repair of the most common clinical temporal muscle atrophy after local disfigurement), combined with bionic artificial bone in surgery, with perfect cosmetic plastic effect.
The patient’s autologous bone marrow stromal cells are extracted and planted in the skeletal gold artificial bone at multiple points to form multiple osteogenic centers, ultimately achieving the most comprehensive anatomical repair of human skull and perfect reconstruction of physiological functions.