Tracheal stents are often used to maintain the patency of the trachea and bronchia in patients suffering from central airway lesions. Metallic tracheal stents are now widely used in the clinical setting, but these types of stents can cause many intractable material-related complications. Biodegradable tracheal stents are made of biodegradable polymer materials with good mechanical strength for maintaining the patency of the lesion segment during a certain period of time, and then they can be gradually degraded into harmless products in human body. Compared with conventional metallic tracheal stent, biodegradable tracheal stents have a good prospect in clinic. In this article, we review the choice of biodegradable tracheal stent materials, experimental progress in biodegradable tracheal stent as well as the challenges we are facing.
Objective To evaluate the internal fixation effect, degradation, and biocompatibility of polylactic-co-glycolic acid/hydroxyapatite (PLGA/HA) absorbable cannulated screws in treatment of lateral femoral condyle fracture of canine so as to provide the theory basis for their further improvement and clinical application. Methods Sixteen adult male Beagles (weighing, 9-12 kg) were selected to prepare the models of bilateral lateral femoral condyle fracture; left fracture was fixed with PLGA/HA absorbable cannulated screws as experimental group and right fracture with metal screws as control group. At 2, 4, 8, and 12 weeks after operation, general observation was done and X-ray films were taken for observing fracture healing; bone mineral density was measured; the histological examination was performed; and the degradation property of absorbable cannulated screws was detected. Results All animals survived to the end of the experiment. General observations showed that no fracture displacement occurred and fracture healed at 12 weeks in 2 groups; no breakage, displacement, or loosening of screws was observed in experimental group. X-ray films results showed that the absorbable cannulated screws could not be found out by X-ray in experimental group, but metal screws could be found out in control group; fracture healed with time in 2 groups. The bone mineral density reached the peak at 8 weeks in 2 groups, and no significant difference was found between 2 groups and among different time points in the same group (P gt; 0.05). Histological examination showed that 2 groups had similar fracture healing process at different time points; no obvious inflammatory reaction was found around absorbable cannulated screws in experimental group. The degradation results of absorbable cannulated screws showed that the intrinsic viscosity and molecular weight distribution obviously decreased at 2 weeks; the number average molecular weight and the weight average molecular weight markedly decreased at 4 weeks; and the maximum shear force did not decrease obviously at 8 weeks, and then decreased significantly. Significant differences were found in all indexes among different time points in the same group (P lt; 0.05). Conclusion PLGA/HA absorbable cannulated screws and metal screws show similar fracture healing process for fixing lateral femoral condyle fracture of canine, and the absorbable canulated screws have good biocompatibility. The maximum shear force of PLGA/HA absorbable cannulated screw has no obvious decrease during 8 weeks after operation, so it can ensure full healing of fracture.
To investigate the cl inical results and the mechanism of bone heal ing for the repair of bone defects following tumor resection with novel interporous TCP bone graft, and to test the hypothesis of “structural transplantation”. Methods From January 2003 to December 2005, 61 cases of various bone defects following the curettage of the benign bone tumors were treated with interporous TCP, with 33 males and 28 females, including bone fibrous dysplasiain 8 cases, bone cyst in 23 cases, eosinophil ic granuloma in 12 cases, enchondroma in 13 cases, non-ossifying fibroma in 2 cases, and osteoblastoma in 3 cases. Tumor sizes varied from 1.5 cm × 1.0 cm to 7.0 cm × 5.0 cm. The plain X-ray, single photon emission computed tomography (SPECT) and histology examination were obtained at various time points after operation. The in vivo biodegradation rate of the implanted TCP was evaluated based on a semi-quantitive radiographic analyzing method. Histopathology examination was performed in 1 revision case. Results All the patients were followed up for 5 to 24 months after operation. They all had good wound heal ing and bone regeneration. There was neither significant reverse reaction to the transplanted material nor locally inflammatory reaction in all of the cases. The bone defects were repaired gradually from 1 to 6 months after operation (bone heal ing at average 2.6 months after surgery) with a bone heal ing rate up to 96.7%. There was only 1 recurrence case (eosinophil ic granuloma in ischium) 3 months after operation. Given revision operation, this case gained bone heal ing. Radiographically, the interface between the implanted bone and host bone became fuzzy 1 month after implantation, indicating the beginning of new bone formation. Three months later, the absorption of the interporous TCP was noticed from peripheral to the center of the implanted bone evidenced by the vague or fuzzy realm. New bone formation could be seen both in peri pheral and central areas. Six months later, implanted bone and host bone merged together and the bone defect was totally repaired, with 78.9% degradation rate of the implanted TCP. Twelve months later, the majority of the implanted bone was absorbed and bone remodel ing was establ ished. In the cases that were followed up for 24 months, the function of affectedextremity was excellent with good bone remodel ing without recurrence. In 2 cases, SPECT showed that nucl ide uptake could be observed in implanted site and the metabol ic activity was high both in the central as well as the peripheral areas of the graft 1 month after implantation, which was an evidence of osteogenesis. Pathologically, the interporous TCP closely contacted the host bone inside the humerus 1 month after grafting. The interface between the implanted bone and host bone became fuzzy, and vascularized tissue began growing inside the implanted graft as a “l ining” structure. Conclusion The interporous TCP proves to be effective for cl inical reparation of bone defects following tumor resection. The inside three-dimensional porous structure simulates the natural bionic bone structure which is suitable for recruitment related cells in-growth into the scaffold, colonizing and prol iferation companied with the process of vascularize, finally with the new bone formation. The novel interporous TCP may boast both bone conductive and bone inductive activities, as an appeal ing “structural transplantation” bone graft.
The stiffness of an ideal fracture internal fixation implant should have a time-varying performance, so that the fracture can generate reasonable mechanical stimulation at different healing stages, and biodegradable materials meet this performance. A topology optimization design method for composite structures of fracture internal fixation implants with time-varying stiffness is proposed, considering the time-dependent degradation process of materials. Using relative density and degradation residual rate to describe the distribution and degradation state of two materials with different degradation rates and elastic modulus, a coupled mathematical model of degradation simulation mechanical analysis was established. Biomaterial composite structures were designed based on variable density method to exhibit time-varying stiffness characteristics. Taking the bone plate used for the treatment of tibial fractures as an example, a composite structure bone plate with time-varying stiffness characteristics was designed using the proposed method. The optimization results showed that material 1 with high stiffness formed a columnar support structure, while material 2 with low stiffness was distributed at the degradation boundary and inside. Using a bone remodeling simulation model, the optimized bone plates were evaluated. After 11 months of remodeling, the average elastic modulus of callus using degradable time-varying stiffness plates, titanium alloy plates, and stainless steel plates were 8 634 MPa, 8 521 MPa, and 8 412 MPa, respectively, indicating that the use of degradable time-varying stiffness plates would result in better remodeling effects on the callus.