An assessment of market opportunities for bone tape: a novel cranio-maxillofacial surgical device

CMF骨折是由面部和/或头部外伤引起的常见损伤。目前，CMF骨折的治疗采用由金属板和螺钉组成的内固定装置，以在愈合期间对齐和稳定骨折部位。弯曲和塑形钢板型材以使其与断裂部位的几何形状对齐需要专门的轮廓工具、经验和大量的时间投入。术后并发症包括疼痛、体温不耐受和触感，导致再手术率高达50%。这些金属板的高刚性也可能有助于应力屏蔽，从而降低自然骨形成和愈合速度。此外，金属钢板与螺钉的固定只有在骨厚度和密度足够的区域才可行。解剖位置和损伤模式会影响骨质量，从而危及这些部位放置螺钉的适宜性。* * * *

CMF fractures are common injuries resulting from trauma to the face and/or head. CMF fractures are currently treated with internal fixation devices consisting of metallic plates and screws to align and stabilize the fracture site(s) during healing. Bending and shaping plate profiles to align with the fracture site geometry requires specialized contouring tools, experience and significant time input. Post-operative complications including pain, temperature intolerance and palpability, resulting in re-operation rates as high as 50% for removal of hardware. The high rigidity of these metallic plates may also contribute to stress shielding, consequently reducing natural bone formation and healing rates. Furthermore, fixation of metallic plates with screws is only possible in regions containing adequate bone thickness and density. The anatomic location and injury pattern can impact bone quality and subsequently jeopardize suitability of these sites for screw placement. ****