An innovation in vertebroplasty for osteoporotic vertebral compression fracture—— new curved percutaneous vertebroplasty system

Lin Hong, PhD, Dong Jian, PhD, Tian Bo, PhD, Wang Zixiang, MM, Zhuang Chenyang, MM, Jiang Libo, PhD, Li Juan, MD, Zhongshan Hospital of Fudan University; Li Zhenyu, MSME, Peng Yaoer, MSME, Yang Shaolian, MSME, Shanghai Chuangchen Biotechnology Co., Ltd.

Abstract: In the current aging process, osteoporosis has become a crucial public health problem globally. Vertebral compression fracture is one of the most common and serious complications of osteoporosis, which can cause pain, restricted movement, and even death due to complications. Percutaneous vertebroplasty (PVP) is an effective minimally invasive treatment for osteoporotic vertebral compression fractures (OVCFs), and it is in a rapidly developing stage at present. Most of the traditional PVP surgical instruments have disadvantages such as bone cement leakage, recurrence of compression fractures in adjacent segments, greater trauma to patients, and long operation time due to technical limitations. This project chooses nickel-titanium alloy as the raw material to study the shaping, rolling, welding, and sterilization methods. Relying on the Zhongshan Hospital of Fudan University, we innovatively design and develop a new type of curved PVP system, which can reach contralateral centrum by unilateral puncture, reduce trauma, realize directing, positioning, multi-point and precise injection, effectively reduce blood vessel damage, local hematoma and bone cement leakage rate, arc-shaped disperse to fill bone cement, provide ideal biomechanical support, reduce the incidence of secondary fractures, and orderly utilize bone cement from mixing to injection steps. A survey showed a potential of approximate 100,000 consumers just in Shanghai, let alone nationwide and worldwide. While saving economic cost, it also helps numerous patients reduce postoperative complications and speed up the recovery process.