The new-generation coronary stents are expected to be biodegradable, and then the biocompatibility along with biodegradation becomes more challenging. It is a critical issue to choose appropriate biomimetic conditions to evaluate biocompatibility. Compared with other candidates for biodegradable stents, iron-based materials are of high mechanical strength, yet have raised more concerns about biodegradability and biocompatibility. Herein, a metal-polymer composite strategy is applied to accelerate the degradation of iron-based stents in vitro and in a porcine model. Furthermore, it is found that serum, the main environment of vascular stents, ensured the safety of iron corrosion through its antioxidants. This work highlights the importance of serum, particularly albumin, for an in vitro condition mimicking blood-related physiological condition, when reactive oxygen species, inflammatory response, and neointimal hyperplasia are concerned. The resultant metal-polymer composite stent is implanted into a patient in clinical research via interventional treatment, and the follow-up confirms its safety, efficacy, and appropriate biodegradability.
The aortic dissection (AD) is a life-threatening disease. The transcatheter endovascular aortic repair (EVAR) affords a minimally invasive technique to save lives of these critical patients, and an appropriate stent-graft gets to be the key medical device during an EVAR procedure. Herein, we report a trilayer stent-graft and corresponding delivery system used for the treatment of the AD disease. The stent-graft is made of nitinol stents with an asymmetric Z-wave design and two expanded polytetrafluoroethylene (ePTFE) membranes. Each of inner and outer surfaces of the stent-graft was covered by an ePTFE membrane, and the two membranes were then sintered together. The biological studies of the sintered ePTFE membranes indicated that the stent-graft had excellent cytocompatibility and hemocompatibility in vitro. Both the stent-graft and the delivery system exhibited satisfactory mechanical properties and operability. The safety and efficacy of this stent-graft and the corresponding delivery system were demonstrated in vivo. In 9 canine experiments, the blood vessels of the animals implanted with the stent-grafts were of good patency, and there were no thrombus and obvious stenosis by angiography after implantation for 6 months. Furthermore, all of the 9 clinical cases experienced successful implantation using the stent-graft and its post-release delivery system, and the one-year follow-ups indicated the preliminary safety and efficacy of the trilayer stent-graft with an asymmetric Z-wave design for interventional treatment.
We report the clinical observation of the effect on 53 surgical cases with Helium-Neon laser local irradiation therapy. Of those cases 15 were suffered from chronic and acute infection, 5 were traumatic, 15 of hernangioma had been treated by solid CO freezing therapy and scierosing injection previously. 18 cases were received incisional irradiation postoperatively. All showed remarkable results. There were no infection, and the healing process was shortened by Helium-Neon laser local irradiation for 2-3 days. The results showed that the curative rate was 88 .68% , the marked effective rate was 9.43 % , and the fair was 1.89%.We emphasize that because of the characteristics of anatomical physiology and histology in children. So the result in children is better than in adults. Thus, we strongly recommend using Helium-Laser local irradiation in surgical pediatric field. It is reliable, safe, painless, convenient, economic, and no side effects at all.
Structurally retrievable drug-eluting stents may have valuable clinical applications because they do not leave any foreign materials inside the patient's body. This article presents a novel design of retrievable peripheral vascular stent and the results from biomechanical analysis of its performance. Using the finite element analysis method, principal parameters of the stent were studied. Moreover, to ensure the practicability of the retrieval process, simulation, and in vitro experiments were performed. The retrieval force reached the maximum value when the whole retrievable part had been retrieved. Furthermore, the force was gradually increased during the retrieval process and remained constant after the main part had been retrieved. When the stent was being compressed, the maximum strain of the stent occurred at the connection between the stent's retrieval part and the main body part, at a value of 4%. The index of nonuniformity of the stent was too small to be counted both at the end of the compression and self-expansion processes. With the increase of moment, the bending stiffness (EI) of the stent decreased gradually. After bending moment was applied, the large strain region was mainly located in the stent's main body part rather than the retrieval part. The results of preliminary stent retrieval experiments demonstrated that the stent could be retrieved successfully. This novel retrievable stent displays promising biomechanical performance. The preliminary experiments demonstrated that the stent could be retrieved smoothly from the blood vessels.
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