Suzhou Origin Medical Technology Co.

Suzhou, China

Suzhou Origin Medical Technology Co.

Suzhou, China
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This invention discloses a directionally biodegradable metallic ligating clip and its preparation method. Said ligating clipcomprises the upper arm, the lower arm and the tail O-type structure for closing blood vessels; before its closing, the upper arm, lower arm and the tail O structure is V-shaped. The upper arm and lower arm are designed with self-lock structures at the ends. When using the clip, place a blood vessel between the upper arm and the lower arm of the V-shaped structure, and squeeze the upper arm and lower arm to gradually decrease their included angle until the self-lock structures of the upper arm and lower arm are interlocked and closed. The inside and outside of said upper arm and lower arm have different microstructures and potentials, the outside grain size is larger than the inside grain size, and the potential of the outside is lower than that of the inside, so as to realize the directional degradation in the direction from blood outside to inside after the closure of ligating clip. This present invention changes the potential through directional changes to the organization structure difference in different parts of the ligating clip material, so as to realize the directional degradation in a different degradation order.


Xia J.,Nanjing Medical University | Chen H.,Nanjing General Hospital | Yan J.,Shanghai JiaoTong University | Wu H.,Shanghai JiaoTong University | And 4 more authors.
ACS Applied Materials and Interfaces | Year: 2017

Magnesium-based materials are promising biodegradable implants, although the impact of magnesium on rectal anastomotic inflammation is poorly understood. Thus, we investigated the inflammatory effects of high-purity Mg staples in rectal anastomoses by in vivo luciferase reporter gene expression in transgenic mice, hematoxylin-eosin staining, immunohistochemistry, and Western blotting. As expected, strong IL-1β-mediated inflammation and inflammatory cell infiltration were observed 1 day after rectal anastomoses were stapled with high-purity Mg or Ti. However, inflammation and inflammatory cell infiltration decreased more robustly 4-7 days postoperation in tissues stapled with high-purity Mg. This rapid reduction in inflammation was confirmed by immunohistochemical analysis of IL-6 and TNF-α. Western blot also suggested that the reduced inflammatory response is due to suppressed TLR4/NF-κB signaling. In contrast, MCP-1, uPAR, and VEGF were abundantly expressed, in line with the notion that expression of these proteins is regulated by feedback between the VEGF and NF-κB pathways. In vitro expression of MCP-1, uPAR, and VEGF was also similarly high in primary rectal mucosal epithelial cells exposed to extracts from Mg staples, as measured by antibody array. Collectively, the results suggest that high-purity Mg staples suppress the inflammatory response during rectal anastomoses via TLR4/NF-κB and VEGF signaling. © 2017 American Chemical Society.


Chen Y.,Nanjing Medical University | Sun N.,Nanjing Medical University | Zhang J.,Nanjing Medical University | Zhang S.,Suzhou Origin Medical Technology Co. | And 2 more authors.
Experimental and Therapeutic Medicine | Year: 2017

To investigate the effects of Mg-6Zn alloy on the healing of the common bile duct (CBD), Mg-6Zn alloy stents were implanted into the CBDs of rabbits. Stainless steel stents were transplanted into a second group of rabbits to serve as a control. Computed tomography (CT) scanning was performed and weight loss was recorded to evaluate the in vivo degradation process. Hematoxylin and eosin staining and immunohistochemical analyses were performed to determine the expressions of transforming growth factor (TGF)-β, vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) and evaluate CBD healing. The Mg-6Zn stents maintained ~82 and ~50% of the original length, and ~90 and ~43% of the original CT value at 1 and 2 weeks post-operatively, respectively. The residual weights of the Mg-6Zn stents were ~89, ~42 and ~9% of the original weights at 1, 2 and 3 weeks post-operatively, respectively. At 3 weeks post-surgery, the CBD was completely healed, with no wounds observed in the 3 groups. VEGF expression in the Mg-6Zn stent group was lower than that in the stainless steel stent group at 3 weeks post-surgery (P=0.002). No significant differences were observed between the mean expressions of the TGF-β1 and bFGF genes at 1 and 2 weeks post-surgery. The results of the present study suggest that degradation of the Mg-6Zn alloy may not affect healing of the CBD. © 2017, Spandidos Publications. All rights reserved.


Han P.,Shanghai JiaoTong University | Tan M.,Shanghai Institute of Technology | Zhang S.,Suzhou Origin Medical Technology Co. | Ji W.,Shanghai JiaoTong University | And 6 more authors.
International Journal of Molecular Sciences | Year: 2014

A type of specially designed pin model of Mg-Zn alloy was implanted into the full thickness of lesions of New Zealand rabbits' femoral condyles. The recovery progress, outer surface healing and in vivo degradation were characterized by various methods including radiographs, Micro-CT scan with surface rendering, SEM (scanning electron microscope) with EDX (Energy Dispersive X-ray analysis) and so on. The in vivo results suggested that a few but not sufficient bridges for holding force were formed between the bone and the implant if there was a preexisting gap between them. The rapid degradation of the implantation in the condyle would result in the appearance of cavities. Morphological evaluation of the specially designed pins indicated that the cusp was the most vulnerable part during degradation. Furthermore, different implantation sites with distinct components and biological functions can lead to different degradation rates of Mg-Zn alloy. The rate of Mg-Zn alloy decreases in the following order: implantation into soft tissue, less trabecular bone, more trabecular bone, and cortical bone. Because of the complexities of in vivo degradation, it is necessary for the design of biomedical Mg-Zn devices to take into consideration the implantation sites used in clinics. © 2014 by the authors; licensee MDPI, Basel, Switzerland.


PubMed | Peking University, Shanghai JiaoTong University, Shanghai Institute of Technology and Suzhou Origin Medical Technology Co.
Type: Journal Article | Journal: International journal of molecular sciences | Year: 2014

A type of specially designed pin model of Mg-Zn alloy was implanted into the full thickness of lesions of New Zealand rabbits femoral condyles. The recovery progress, outer surface healing and in vivo degradation were characterized by various methods including radiographs, Micro-CT scan with surface rendering, SEM (scanning electron microscope) with EDX (Energy Dispersive X-ray analysis) and so on. The in vivo results suggested that a few but not sufficient bridges for holding force were formed between the bone and the implant if there was a preexisting gap between them. The rapid degradation of the implantation in the condyle would result in the appearance of cavities. Morphological evaluation of the specially designed pins indicated that the cusp was the most vulnerable part during degradation. Furthermore, different implantation sites with distinct components and biological functions can lead to different degradation rates of Mg-Zn alloy. The rate of Mg-Zn alloy decreases in the following order: implantation into soft tissue, less trabecular bone, more trabecular bone, and cortical bone. Because of the complexities of in vivo degradation, it is necessary for the design of biomedical Mg-Zn devices to take into consideration the implantation sites used in clinics.


PubMed | Shanghai JiaoTong University, Suzhou Origin Medical Technology Co. and Peking University
Type: | Journal: Biomaterials | Year: 2016

Interference screw in the fixation of autologous tendon graft to the bone tunnel is widely accepted for the reconstruction of anterior cruciate ligament (ACL), but the regeneration of fibrocartilaginous entheses could hardly be achieved with the traditional interference screw. In the present work, biodegradable high-purity magnesium (HP Mg) showed good cytocompatibility and promoted the expression of bone morphogenetic protein-2 (BMP-2) and vascular endothelial growth factor (VEGF), fibrocartilage markers (Aggrecan, COL2A1 and SOX-9), and glycosaminoglycan (GAG) production invitro. The HP Mg screw was applied to fix the semitendinosus autograft to the femoral tunnel in a rabbit model of ACL reconstruction with titanium (Ti) screw as the control. The femur-tendon graft-tibia complex was retrieved at 3, 6, 9 and 12 weeks. Gross observation and range of motion (ROM) of the animal model reached normal levels at 12 weeks. No sign of host reaction was found in the X-ray scanning. The HP Mg group was comparable to the Ti group with respect to biomechanical properties of the reconstructed ACL, and the ultimate load to failure and stiffness increased 12 weeks after surgery. In the histological analysis, the HP Mg group formed distinct fibrocartilage transition zones at the tendon-bone interface 12 weeks after surgery, whereas a disorganized fibrocartilage layer was found in the Ti group. In the immunohistochemical analysis, highly positive staining of BMP-2, VEGF and the specific receptor for BMP-2 (BMPR1A) was shown at the tendon-bone interface of the HP Mg group compared with the Ti group. Furthermore, the HP Mg group had significantly higher expression of BMP-2 and VEGF than the Ti group in the early phase of tendon-bone healing, followed by enhanced expression of fibrocartilage markers and GAG production. Therefore we proposed that the stimulation of BMP-2 and VEGF by Mg ions was responsible for the fibrochondrogenesis of Mg materials. HP Mg was promising as a biodegradable interference screw with the potential to promote fibrocartilaginous entheses regeneration in ACL reconstruction.


Cheng P.,Shanghai JiaoTong University | Zhao C.,Shanghai JiaoTong University | Han P.,Shanghai JiaoTong University | Ni J.,Shanghai JiaoTong University | And 4 more authors.
Journal of Materials Science and Technology | Year: 2016

Magnesium (Mg) has been widely accepted as osteoconductive biomaterial, but osseointegration of Mg device at different implantation sites is still unclear. In the present study, high-purity magnesium (HP Mg) pins were implanted into femoral shaft and condyle of New Zealand rabbits concurrently. 2, 8, 12 and 16 weeks after surgery, rabbit femurs were harvested for micro-computed tomography (micro-CT) scanning and subsequent histological examinations. HP Mg pins were retrieved for scanning electron microscope and energy dispersive spectrum (SEM/EDS) analyses. HP Mg pins at both implantation sites performed stable corrosion with mineral deposition and bone incorporation on surface. However, difference in distribution of contact osteogenesis centers and biological properties of peri-implant bone tissues was detected between femoral shaft and femoral condyle. In femoral condyle, contact osteogenesis centers originated from both periosteum and cancellous bones and the whole HP Mg pin was encapsuled in trabecular bone at 16 weeks. Meanwhile, bone volume to total bone volume (BV/TV) and bone mineral density (BMD) of peri-implant bone tissues were above those of normal bone tissues. In femoral shaft, contact osteogenesis centers were only from periosteum and direct bone contact was confined in cortical bone, while BV/TV and BMD kept lower than normal. Furthermore, new formation of peri-implant bone tissues was more active in femoral condyle than in femoral shaft at 16 weeks. Therefore, although HP Mg performed good biocompatibility and corrosion behavior in vivo, its bioadaption of osseointegration at different implantations sites should be taken into consideration. Bone metaphysic was suitable for Mg devices where peri-implant bone tissues regenerated rapidly and the biological properties were close to normal bone tissues. © 2016.


Wang Z.,Shanghai JiaoTong University | Yan J.,Shanghai JiaoTong University | Li J.,Shanghai JiaoTong University | Zheng Q.,Shanghai JiaoTong University | And 2 more authors.
Materials Science and Engineering B: Solid-State Materials for Advanced Technology | Year: 2012

In this study, intestinal epithelial cells (IEC)-6 were cultured in different concentration extracts of Mg-6Zn alloys for different time periods. To achieve a total of three concentrations (100%, 60% and 20% concentration), the extracts were serially diluted with Dulbecco's modified Eagle medium High Glucose to observe a dose-response relationship. We studied the indirect effects of Mg-6Zn alloys on IEC-6 cells apoptosis. The apoptosis of IEC-6 cells was measured using flow cytometry. And the apoptosis of IEC-6 cells was evaluated by investigating the expression of caspase-1and Bcl-2 using real-time polymerase chain reaction (PCR) and Western blotting tests. It was found that the levels of apoptosis in IEC-6 cells cultured in 100% Mg-6Zn alloy extracts were significantly higher than those in 60% and 20% extracts; the 100% extract can down-regulate expression of Bcl-2 after culture. The in vitro results indicated that the conspicuous alkaline environment and excessive Mg concentration, even Zn concentration caused by rapid corrosion of Mg-6Zn alloys promote IEC-6 cells apoptosis, although further experiments will be necessary to formally prove our conclusions. Therefore, the adjustment of the degradation rate is needed for using Mg-Zn alloy as a surgical suture material. © 2012 Elsevier B.V. All rights reserved.


Chen Y.,Shanghai JiaoTong University | Yan J.,Shanghai JiaoTong University | Zhao C.,Shanghai JiaoTong University | Zhang S.,Suzhou Origin Medical Technology Co. | And 5 more authors.
Journal of Materials Science: Materials in Medicine | Year: 2014

There is a great clinical need for biodegradable bile duct stents. Biodegradable stents made of an Mg-6Zn alloy were investigated in both vivo animal experiment and in vitro cell experiments. During the in vivo experiments, blood biochemical tests were performed to determine serum magnesium, serum creatinine (CREA), blood urea nitro-gen (BUN), serum lipase (LPS), total bilirubin (TB) and glutamic-pyruvic transaminase (GPT) levels. Moreover, tissue samples of common bile duct (CBD), liver and kidney were taken for histological evaluation. In the in vitro experiments, primary mouse extrahepatic bile duct epithelial cells (MEBDECs) were isolated and cultured. Cytotoxicity testing was carried out using the MTT method. Flow cytometry analyses with propidium iodide staining were performed to evaluate the effect of Mg-6Zn alloy extracts on cell cycle. The in vivo experiments revealed no significant differences (P > 0.05) in serum magnesium, CREA, BUN, LPS, TB or GPT before and after the operation. Based on the HE results, hepatocytes, bile duct epithelial cells, renal glomerulus and renal tubule tissues did not present significant necrosis. In the in vitro experiments, the cell relative growth rate curve did not change significantly from 20 to 40 % extracts. In vitro experiments showed that 20-40 % Mg-6Zn extracts are bio-safe for MEBDECs. In vivo experiments showed that Mg-6Zn stents did not affect several important bio-chemical parameters or, harm the function or morphology of the CBD, kidney, pancreas and liver. Our data suggested that this Mg-6Zn alloy is a safe biocompatible material for CBD. © 2013 Springer Science+Business Media New York.


Han P.,Shanghai JiaoTong University | Cheng P.,Shanghai JiaoTong University | Zhao C.,Shanghai JiaoTong University | Zhang S.,Suzhou Origin Medical Technology Co. | And 4 more authors.
Journal of Materials Science and Technology | Year: 2016

Bone screws encounter complex mechanical environment in fracture fixation of weight-bearing bone. In the present study, high-purity magnesium (HP Mg) screws were applied in fixation of rabbit femoral intracondylar fracture with 3 mm gap. In the control group, HP Mg screws of the same design were implanted at corresponding position of contralateral leg. At 4, 8 and 16 weeks after surgery, retrieved femurs went through micro-computed tomography (micro-CT) scanning and hard tissue processing. Under mechanical stress involved in fracture fixation, bending of screw bolt was observed at the portion exposed to facture gap at 4 weeks. Then local corrosion at the same portion was detected 16 weeks after surgery, which indicated the accumulation effect of mechanical stress on Mg corrosion. HP Mg screws in the fracture group had no significant difference with the control group in screw volume, surface area, surface-to-volume ratio (S/. V). And peri-implant bone volume/tissues volume (BV/TV) and bone volume density (BMD) in the fracture group was comparable to that in the control group. Furthermore, histological analysis showed new formed bone tissues in fracture gap and fracture healing 16 weeks after surgery. Under mechanical stress, HP Mg screw suffered bolt bending and local corrosion at the portion exposed to fracture gap. But it had no influence on the integral corrosion behaviors, osseointegration of HP Mg screw and the fracture healing. Therefore, HP Mg screws possessed good potential in fracture fixation of weight-bearing bones. © 2016.

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