In this paper, industry development and market tendency, supervision and standardization of nanomaterial-contained medical devices are overviewed comprehensively based on a large number of reference data including national and international information. Furthermore, the consideration about standardization of biological evaluation for nanomaterial-contained medical devices is discussed by combined some works performed in our laboratory.
Device Approval ; Equipment and Supplies ; standards ; Nanostructures ; standards

The serum sialic acid level and its relation to stroke in syndrome X was observed in 21 syndrome X patients with history of stroke,21 syndrome X patients without history of stroke, 21 simple NIDDM patients and 21 healthy subjects matched for age, sex, duration of diabetes and HBAlc level.The results showed that the serum sialic acid level was significantly higher in all NIDDM patients than in normal subjects(P

Intervertebral disc (IVD) degeneration is considered to be the main cause of low back pain (LBP),however,there are lack of long-lasting and effective methods of clinical treatment.Tissue engineering technique based on stem cells becomes an essential research direction on repair of IVD degeneration at present,and its effectiveness and feasibility have been confirmed,but it is difficult to maintain the sufficiency and vitality of stem cells in IVD.Previous studies showed that stem cells existed naturally in IVD,and stem cells from stem cell niche could migrate to IVD physiologically to maintain the IVD environment balance under the adverse microenvironment.Unfortunately,these behaviors cannot preclude IVD degeneration.Therefore,theoretical basis for the regeneration of nucleus pulposus (NP) in situ can be obtained from studying the mechanism that the endogenous repair failure during IVD degeneration,the cell death and the migration of stem cells in IVD,and the key regulatory targets to sustain the quantity and quality of the stem cells.Although there have been few researches to study the mechanism of the cell death and the migration of stem cells in IVD so far,studies demonstrated that the major inducing factors of IVD degeneration (pressure and hypoxia) could decrease the number of NP cells by autophagy,apoptosis and necroptosis,and chemokines and their receptors played a critical role in the migration of mesenchymal stem cells.These researches provide a clue for studying the mechanism of endogenous repair failure during IVD degeneration.We reviewed the current research situation and progress of the mechanism that endogenous repair failure during IVD degeneration in the following articles.First,we exhibited the potential of IVD stem cells in IVD degeneration repair.Second,the effect of the adverse microenvironment (pressure,hypoxia,etc) on the migration of IVD stem cells was discussed.Third,the mechanism of the stem cell death,autophagy,apoptosis and necroptosis under the adverse (pressure,hypoxia,etc.) microenvironment,and the correlation between the IVD stem cells migration and autophagy,apoptosis and necroptosis was studied.And then tissue engineering of NP was also discussed to achieve the endogenous repair of IVD degeneration.These studies will provide an innovative research direction on endogenous repair and a new strategy of early therapy for IVD degeneration.

With the appearance and development of ultrasonic surgical installation, ultrasonic therapy enters on a new epoch. High-amplitude and high-power ultrasonic vibration produced during the operation, ultrasonic surgical installation can be used to decrease the amount of bleeding or stop bleeding according to the acoustic properties of different tissues. The part where pathological changes happen can be excised selectively by ultrasonic surgical installation. This article introduces the principle, structure, classification and clinical application of ultrasonic surgical installation in detail.

Objective To analyze the balance function of injured lower lim b by dynam ic posturography. Methods Using the dynam ic posturography instrum ent, the postural evoked responses of sixty-two norm al people and two hundred and fifty-eight people with injured lower lim b bones and joints were detected. The test was included sensory organization test(SO T) and adaption test(ADT).The results of two groups were com pared by t test. Results Com pared with the norm al people, the im paired people had significant statistical differences in balance scores of SO T3-SO T6 and proportion score of dynam ic proprioception (P<0.05). There was no obvious decrease in ADT. Conclusion The balance function of injured lower lim b significantly decreases.

Objective To discuss the technique′s characteristics, manifestation, clinical application, and limit in normal and abnormal pediatric airway by using CTVB (CT virtual bronchoscopy) in comparison with FOB (fiberoptic bronchoscopy). Methods Spiral scans were performed by a GE Hispeed spiral scanner in 113 pediatric chests The reformed images of 45 patients were transported to a workstation by which 3 D reconstructions were performed with a software named Navigator and CTVB was generated Results Bronchi were manifested 100% in grades Ⅰ-Ⅲ, 46 7% and 13 3% were revealed in grade Ⅳ and V with CTVB, respectively FOB can only enter grade Ⅰ-Ⅲ bronchi, only 62 2% of the lobar bronchi can be manifested by FOB The findings of CTVB were stenosis ( n =34), occlusion ( n =11), and mass ( n =16) Only 3 radiotransparent foreign bodies and 2 inflammatory emboli were misdiagnosed as tumors, the rest was consistent with FOB Conclusion CTVB is an important supplement to conventional CT, CTVB can detect intraluminal space occupying lesions and occlusions or stenosises caused by all kinds of causes,but lack specificity CTVB can fly through the occlusions or stenosises of the lumen and enter the distal bronchi, thus can make up for the disadvantages of FOB It can′t make the diagnosis independently and must join together the CT primitive the diagram resemble or rebuild the diagram resemble proceeds to synthesize the analysis

BACKGROUND: Bone exposed wounds are frequently required to deal with in orthopaedic surgeries, involving the treatment of open fractures, bone tumors, osteomyelitis, and many other diseases, in which the defect of soft tissue caused by open fractures is the most difficult to deal with. Conventional debridement or negative pressure closed drainage technology is difficult to make bone exposed wounds heal, and the process is extremely cumbersome, during which,patients suffer a lot of pain.OBJECTIVE: To evaluate the advantages and disadvantages of the various types of dressings, and review the application of new hydrogel dressing in bone exposed wounds based on its advantages, such as keeping wound environment moisture, restoring skin physical barrier, contributing to routine dressing change.METHODS: A computer-based online retrieval of PubMed and CNKI databases was performed to search papers published between 2000 and 2016 using the key words hydrogel dressing, bone exposed wound, traditional wound dressing, antibiotic in English and Chinese, respectively. A total of 55 papers suitable for final analysis from the application of traditional and new dressings in bone tissue engineering were reviewed.RESULTS AND CONCLUSION: The treatment of bone exposed wounds involves the treatment of many diseases, such as open fractures, bone tumors, osteomyelitis, which is still an orthopedic problem to solve. The novel hydrogel dressings with unique advantages are able to provide better plans for bone exposed wounds, and the use of these dressings solves the regeneration and repair of exposed bone, and improves the infection of antibiosis. In addition, the gel dressings currently have become a hot spot of research because of the characteristics of sustained-release.

Objective To explore the clinical outcomes of treating unstable intertrochanteric fractures with proximal femoral locking plate (PFLP) in the elderly patients.Methods From January 2010 to June 2015,380 elderly patients with unstable intertrochanteric fracture were treated with PFLP and successfully followed up at our department.They were 171 men and 209 women,from 60 to 89 years of age (average,68.7 years).By AO classification,there were 58 cases of AO31-A2.2,87 ones of 31-A2.3,130 ones of 31-A3.1,63 ones of 31-A3.2,and 42 ones of 31-A3.3.Operation time,incision length,length of hospital stay,fracture healing time,postoperative complications and hip joint Harris scores were recorded.Results This cohort was followed up for an average of 13.3 months (range,from 8 to 21 months).Their operation time averaged 53.2 min,X-ray exposure 12.2 times,intraoperative blood loss 92.7 mL,incision length 12.6 cm,postoperative drainage volume 54.7 mL,and length of hospital stay 9.2 days.Pulmonary infection was observed in 3 cases,fixation loosening in 8,fixation breakage in 2,hip varus in 9,and fracture nonunion in 4,yielding a total complication rate of 6.8％ (26/380).No operative incision infection was observed.The average fracture healing time was 11.8 weeks (range,from 7 to 48 weeks) after operation.The average Harris score one year postoperation for the 380 patients was 86.3 ± 6.1,significantly higher than the preoperative value (43.6±4.4) (P ＜0.05).There were 96 excellent,231 good,42 fair and 11 poor cases,giving an excellent to good rate of 86.1％.Conclusion Since PFLP has advantages of limited invasion,blood loss and complications,a high rate of fracture healing,and good functional recovery of the hip,it may be a good treatment for unstable intertrochanteric fractures in the elderly patients.

Objective To investigate the clinical characteristics, diagnosis, treatment and prognosis of hepatic angiomyolipoma (HAML). Methods The clinical data of 14 patients with hepatic angiomyolipoma admitted in our hospital from 1989 to 2007 were analyzed retrospectively. Result There were 4 male patients and 10 female patients. Median age was 41 years old. The lesions located in right lobe in 8 patients, and in left lobe in 6 patients. B-US was taken in 12 patients before operation, and other examinations included CT in 8 patients, MRI in 7 patients and angiography in 2 patients. Five patients were diagnosed with HAML by imagine features. Fine needle biopsy was taken in 1 patient with no definite diagnosis. All patients underwent resection and got the histopathologic diagnosis with HAML. All specimens were HMB-45 positive. S-100 and SMA were tested in 7 and 6 patients respectively, and were positive in all those patients. All cases were followed up for 6 months to 18 years (median time was 3 years). 13 patients were still alive without recurrence and 1 patient died of postoperative DIC and heart failure. Conclusion There was marked female predominance in HAML. Imaging features are helpful for preoperative diagnosis of HAML, but correct diagnosis was achieved in only a fraction of patients. HMB-45 positive was definitive proof for histopathologic diagnosis of HAML. Hepatectomy was an effective treatment for HAML.

The aim of this study was to establish an assessment method for determining α-Gal (α-1, 3-galactosyle) epitopes contained in animal tissue or animal tissue-derived biological materials with ELISA inhibition assay. Firstly, a 96 well plate was coated with Gal α-1, 3-Gal/bovine serum albumin (BSA) as a solid phase antigen and meanwhile, the anti-α-Gal M86 was used to react with α-Gal antigens which contained in the test materials. Then, the residual antibodies (M86) in the supernatant of M86-Gal reaction mixture were measured using ELISA inhibition assay by the α-Gal coating plate. The inhibition curve of the ELISA inhibition assay, the R2 = 0.999, was well established. Checking using both α-Gal positive materials (rat liver tissues) and α-Gal negative materials (human placenta tissues) showed a good sensitivity and specificity. Based on the presently established method, the α-Gal expression profile of rat tissues, decellular animal tissue-derived biological materials and porcine dermal before and after decellular treatment were determined. The M86 ELISA inhibition assay method, which can quantitatively determine the α-Gal antigens contained in animal tissues or animal tissue-derived biomaterials, was refined. This M86 specific antibody based-ELISA inhibition assay established in the present study has good sensitivity and specificity, and could be a useful method for determining remnant α-1, 3Gal antigens in animal tissue-derived biomaterials.
Animals ; Antibodies ; Biocompatible Materials ; Enzyme-Linked Immunosorbent Assay ; methods ; Epitopes ; analysis ; Humans ; Rats ; Sensitivity and Specificity ; Serum Albumin, Bovine ; Trisaccharides ; analysis