Controllable cured calcium sulfate bone-cementing agent and its preparation method

Abstract

The related preparation method for a controllable solidifying CaSO4 bone adhesive comprises: mixing 40-80wt% dehydrated CaSO4 and 1-20wt% adjuvant to age for 1-48h, mixing material and 10-50wt% solidifying solution for 2-5min, and hydrating to obtain the slurry. This invention has well performance for medical purpose.

Description

technical field [0001] The invention relates to the technical field of medical materials, in particular to a controllable curing calcium sulfate bone adhesive and a preparation method thereof. Background technique [0002] In clinical treatment, for severe comminuted fractures, bone loss in the fracture area, or osteoporosis, it is difficult to fix with plaster alone, and the risk of secondary displacement and malunion of the fracture is high, and internal fixation techniques are often required; in addition, Abnormal curvature of the spine, spinal trauma, spinal infection or tumor will all cause spinal lesions, and further common clinical diseases such as spondylolisthesis and lumbar disintegration will occur. , the method of autologous or allogeneic bone graft repair; although autologous bone is the most ideal bone graft material, on the one hand, due to its limited source, it cannot meet the cases requiring a large number of bone grafts; on the other hand, it will cause va...

AI Technical Summary

Problems solved by technology

[0002] In clinical treatment, for severe comminuted fractures, bone loss in the fracture area, or osteoporosis, it is difficult to fix with plaster alone, and the risk of secondary displacement and malunion of the fracture is high, and internal fixation techniques are often required; in addition, Abnormal curvature of the spine, spinal trauma, spinal infection or tumor will all cause spinal lesions, and further common clinical diseases such as spondylolisthesis and lumbar disintegration will occur. , the method of autologous or allogeneic bone graft repair; although autologous bone is the most ideal bone graft material, on the one hand, due to its limited source, it cannot meet the cases requiring a large number of bone grafts; on the other hand, it will cause various complications in the bone harvesting area. disease, which not only brings extra pain to patients, but also affects the timely functional recovery of patients after surgery; allogeneic bone mainly comes from corpses, animals, and family members of patients. Although the source is relatively sufficient, allogeneic bone is prone to immune rejection, infection of hepatitis, HIV, etc., the graft failure rate is also high; and the allograft bone is replaced slowly, and the new bone volume is relatively small

In order to solve the repair and fixation of these bone defect areas, a large number of new artificial materials have been studied. At present, polymethyl methacrylate (PMMA) bone cement is commonly used, although it has good adhesion and good mechanical properties. , but because it cannot be degraded, there is a problem of taking out the implant in a second operation, and the deviation of biocompatibility will cause fibrosis at the implantation site

Although polylactic acid material has good biocompatibility and mechanical properties, it can only be molded in vitro and then implanted in the body for bone repair, which limits its application in bone adhesive materials and reducing surgical trauma.

Calcium phosphate bone cement materials have been studied more recently, and some products are also on the market at home and abroad, but their existing strength is relatively low, and because of their fast curing speed, they cannot meet the requirements of surgical operations, resulting in short operation time and cannot be used as a good bone cement. Use of a Bone Adhesive

Domestic patent CN1446588 (glass-based nano-hydroxyapatite biocement and its preparation method) and other synthetic bone adhesives have a short operating time, and due to the change of pH value during the curing process, some inflammatory reactions in the human body will be caused. , and faster curing speed will bring greater heat release, increasing the patient's discomfort

Calcium sulfate materials have been studied for nearly a hundred years. As early as 1928, some scholars used calcium sulfate to treat bone infection in dogs. In 1964, LEONARD F. et al. studied the use of calcium sulfate for bone repair. After the 1980s, various calcium sulfate products emerged one after another, but the controllability of the curing time of the material and the mechanical properties of the material after curing were not ideal.