[Research on Chemical Equivalence Characteristics of Polylactic Acid in Medical Devices].

Polylactic acid is synthesized indirectly by the polymerization method, according to the standard GB/T 16886.18-2011, the evaluation parameters and methods about chemical characterization of polylactic acid have been established. By using rigorous and comprehensive comparative analysis, the chemical equivalency of domestic and imported polylactic acid materials has been proved, along with the "Medical Device Biology Evaluation and Review Guide", paving the way of using domestic polylactic acid in implantable medical devices.

Hybrid interpenetrating network of polyester coronary stent with tunable biodegradation and mechanical properties.

Poly(l-lactide) (PLLA) is an important candidate raw material of the next-generation biodegradable stent for percutaneous coronary intervention, yet how to make a polyester stent with sufficient mechanical strength and relatively fast biodegradation gets to be a dilemma. Herein, we put forward a hybrid interpenetrating network (H-IPN) strategy to resolve this dilemma. As such, we synthesize a multi-functional biodegradable macromer of star-like poly(d,l-lactide-co-ɛ-caprolactone) with six acrylate end groups, and photoinitiate it, after mixing with linear PLLA homopolymer, to trigger the free radical polymerization. The resultant crosslinked polymer blend is different from the classic semi-interpenetrating network, and partial chemical crosslinking occurs between the linear polymer and the macromer network. Combined with the tube blow molding and the postprocessing laser cutting, we fabricate a semi-crosslinked-polyester biodegradable coronary stent composed of H-IPN, which includes a physical network of polyester spherulites and a chemical crosslinking network of copolyester macromers and a part of homopolymers. Compared with the currently main-stream PLLA stent in research, this H-IPN stent realizes a higher and more appropriate biodegradation rate while maintaining sufficient radial strength. A series of polymer chemistry, polymer physics, polymer processing, and in vitro and in vivo biological assessments of medical devices have been made to examine the H-IPN material. The interventional implanting of the H-IPN stent into aorta abdominalis of rabbits and the follow-ups to 12 months have confirmed the safety and effectiveness.

Calcium-cation-doped polydopamine-modified 2D black phosphorus nanosheets as a robust platform for sensitive and specific biomolecule sensing.

Many polymer decorated/modified 2D nanomaterials have been developed as enhanced drug delivery systems and photothermal theranostic nanoagents. However, few reports describe the use of these novel nanomaterials as nanoplatforms for biomolecule sensing. Herein, we used calcium-cation-doped polydopamine-modified (PDA-modified) 2D black phosphorus (BP) nanosheets (BP@PDA) as a sensing nanoplatform for the detection of nucleic acids and proteins in complex biological samples. Fluorescent-dye-labeled single-strand DNA aptamer/probes are adsorbed by the Ca2+-doped BP@PDA mediated by calcium-cation coordination. The PDA coating enhances the stability of the inner BP, provides binding sites to DNA nucleobases, and quenches fluorescence. Without any chemical conjugation, this sensing nanoplatform selectively and specifically detects protein (human thrombin, linear range: 10-25 nM, detection limit: 0.02 nM), single-strand DNA (linear range: 1-10 nM, detection limit: 0.52 nM) in 1% serum diluted samples, and senses intracellular mRNAs (C-myc, and actin) in living cells. The nanoplatform exhibits the advantages of both the 2D nanomaterial (BP) and the coating polymer (PDA), naturally enters living cells unaided by transfection agents, resists enzymatic lysis and shows high biocompatibility. This nanoplatform design contributes towards future biomolecule analytical method development based on polymer decorated/modified 2D nanomaterials.

Biodegradable atrial septal defect occluders: A current review.

Atrial septal defect (ASD) is a common structural congenital heart disease. With the development of interventional closure devices and transcatheter techniques, interventional closure therapy has become the most well-accepted therapeutic alternative worldwide, as it offers a number of advantages over conventional therapies such as improved safety, easier operation, lower complication rates and invasiveness, and shorter anesthetic time and hospitalizations. During the past decades, various types of occluders based on nondegradable shape memory alloys have been used in clinical applications. Considering that the permanent existence of foreign nondegradable materials in vivo can cause many potential complications in the long term, the research and development of biodegradable occluders has emerged as a crucial issue for interventional treatment of ASD. This review aims to summarize partially or fully biodegradable occlusion devices currently reported in the literature from the aspects of design, construction, and evaluation of animal experiments. Furthermore, a comparison is made on the advantages and disadvantages of the materials used in biodegradable ASD occlusion devices, followed by an analysis of the problems and limitations of the occlusion devices. Finally, several strategies are proposed for future development of biodegradable cardiac septal defect occlusion devices. STATEMENT OF SIGNIFICANCE: Although occlusion devices based on nondegradable alloys have been widely used in clinical applications and saved numerouspatients, biodegradable occlusion devices may offer some advantages such as fewer complications, acceptable biocompatibility, and particularly temporary existence, thereby leaving "native" tissue behind, which will certainly become the development trend in the long term. This review summarizes almost all partially or fully biodegradable occlusion devices currently reported in the literature from the aspects of design, construction, and evaluation of animal experiments. Furthermore, a comparison is made on the advantages and disadvantages of the materials used in biodegradable ASD occlusion devices, followed by an analysis of the problems and limitations of the occlusion devices. Finally, several strategies are proposed for future development of biodegradable cardiac septal defect occlusion devices.

Design and evaluation of a novel biodegradable inferior vena cava filter.

Inferior vena cava filter has been increasingly applied in clinical practice to prevent pulmonary embolism. Nowadays, various complications after implanting conventional filters seriously hinder clinical applications. Therefore, in this paper, a novel biodegradable inferior vena cava filter was designed based on biodegradable materials, which is an hourglass-like filter anchored inside a stent structure fixed by connecting fibers. Firstly, mechanical tests in crimp were performed to study the expansion properties of the filter, showing that the biodegradable inferior vena cava filter could achieve self-expansion easily. Furthermore, the biodegradable inferior vena cava filters and fibers were incubated in phosphate buffer media (pH = 7.4 ± 0.2) at 37°C for six months. Scanning electron microscope micrograph showed that the stents exhibited no significant dimensional and structural changes and had enough radial force to support the vessel. During the degradation period, the results of scanning electron microscope, gel permeation chromatography, differential scanning calorimetry and tensile strength analysis confirmed that the degradation rate of the hourglass-like filter was faster than the connecting fibers, achieving progressive degradation and thus avoiding the polymer fragments from blocking vessel. Cytotoxicity and hemolysis assay demonstrated good biocompatibility of the filter. For 5 mm × 10 mm sized thrombus, in vitro simulated thrombus capture test showed that the mean trapping efficiency of the filter was 90%, which was comparable to traditional inferior vena cava filter. In conclusion, all results exhibited that the as-designed biodegradable inferior vena cava filter has a potential in clinical application for patients who are at temporary high risk of venous thromboembolism.

[Study of DNA examination in trace sample by carrier method].

OBJECTIVE: To solve the problems of DNA testing in trace sample. METHODS: Applying original carrier method to detect known trace blood DNA and to compare it with the results obtained by high effective DNA extracting method of Chelex-100. RESULTS: The carrier method not only could obtain the right STR genotype in the trace blood sample, but also was twice as sensitive as the Chelex-100 method. CONCLUSION: The carrier method could improve the DNA detection in trace sample. It is easy to operate and is much more valuable in the forensic case analysis.

Effects of NasoPore packing in the middle ear cavity of the guinea pig.

OBJECTIVE: To evaluate the effects of NasoPore after packing of the middle ear in guinea pigs. STUDY DESIGN: A randomized, prospective, controlled animal study. SETTING: University laboratory. SUBJECTS AND METHODS: Forty-one guinea pigs were divided into 3 groups. In group 1(n=12), the middle ears of animals were unilaterally implanted with NasoPore, leaving the contralateral middle ears packed with absorbable gelatin sponge soaked in a solution containing kanamycin and furosemide as an ototoxicity-positive control; group 2 (n = 17) underwent the same experimental protocol as group 1, except the gelatin sponge was unsoaked; in group 3 (n = 12), NasoPore was inserted unilaterally and no packing material was placed into the contralateral ear. Auditory brainstem responses (ABRs) were performed preoperatively and 3 months after the procedure. The surface preparation and scanning electron microscopy (SEM) were assessed 3 months postoperatively, whereas pathology of middle ear was analyzed in 5 samples of group 2. RESULTS: ABR thresholds of the contralateral ear significantly increased in group 1 and were slightly shifted in group 2 compared with the NasoPore-packed and nonpacked ears 3 months postoperatively. The NasoPore-packed middle ears were found to have less fibrosis and inflammation and less thickened bone and tympanic membranes than Gelfoam-packed ears. Surface preparations and SEM showed no ototoxicity in the inner ear of NasoPore-packed ears. CONCLUSION: NasoPore appears to be effective for use in otosurgery. It caused less fibrosis in the middle ear than conventional packing agents and no ototoxicity to the inner ear.

Rac/Rho pathway regulates actin depolymerization induced by aminoglycoside antibiotics.

Stress stimuli can lead to remodeling of the actin cytoskeleton and subsequent alteration of cell adhesion and permeation as well as cell functions and cell fate. We investigated redox-dependent Rho GTPase-linked pathways controlling the actin cytoskeleton in the inner ear of the CBA mouse, by using aminoglycoside antibiotics as a noxious stimulus that causes loss of sensory cells via the formation of reactive oxygen species. Kanamycin treatment in vivo interfered with the formation of F-actin, disturbed the arrangement of beta-actin in the stereocilia of outer hair cells, and altered the intermittent adherens junction/tight junction complexes between outer hair cells and supporting cells. The drug treatment also activated Rac1 and promoted the formation of the complex of Rac1 and p67phox while decreasing the activity of RhoA and reducing the formation of the RhoA/p140mDia complex. In inner-ear-derived cell lines, expression of mutated Rac1 changed the structural arrangement of F-actin and diminished the immunoreactivity of p140mDia. These findings suggest that actin depolymerization induced by kanamycin is mediated by Rac1 activation, followed by the formation of superoxide by NADPH oxidase. These changes will ultimately contribute to aminoglycoside-induced loss of hair cells.