Innovative technology for elimination of microbubbles during hemodialysis treatments

项目摘要 美国约有40万名患者，全世界至少有500万名患者每周接受血液透析 (HD)，不可逆转肾功能衰竭的标准长期治疗方法。尽管它通过以下方式彻底改变了这一领域 增加患者的寿命，技术和设备的改进一直停滞不前 几十年。此外，与一般人群相比，HD的过早死亡率仍然很高 患者的症状负担很大，需要频繁住院，并显著 会降低患者的整体生活质量。人们一致认为，导致患者症状的主要因素之一 负担来自房屋署本身的治疗。识别和消除生物应激源的主要困难是 HD治疗产生的问题是，它们中的大多数似乎是微小的低强度不完善的程序 这只会导致健康问题，因为频繁和累积的暴露时间(&gt；600小时/年) HD患者要接受。其中一种应激源被认为是房署治疗不可避免的危险 是空气微泡输液。HD微泡输注主要影响肺部--导致内皮损伤， 动脉粥样硬化、肺血管重塑和呼吸困难--但也在心脏和大脑中发现 病人的数量。目前还没有技术或技术能够从HD中消除大部分 小于100微米的微气泡。Sil Technologies提出了一种声学加速的微气泡 扩散技术，将消除大多数，如果不是所有的微泡存在于体外管内 高清设备。这项拟议的技术使用声学强迫将微气泡推向 可透气的硅胶管。硅胶管被脱气水包围。这两种技术的结合 声学强迫和气体浓度差(气泡和脱气水之间)提供了很强的 扩散驱动力，即使穿过厚膜(厚度大于0.5 mm)也能工作。我们 希望通过完成以下具体目标来证明该技术的可行性：i)声学 共振室的设计将通过以下方式最大化声力和气泡扩散锚定位置 有限元模拟。Ii)i)中设计的装置将被建造并在线安装到流体回路上 由蠕动泵提供动力，充满透明的模拟血液液体。脉冲多普勒微泡 将在设备的入口和出口位置放置柜台，以收集必要的数据以确定 概念的有效性。最后，iii)液体回路将充满真实的血液和实验 在II中进行的将重复进行。血意志仪作用效果的统计分析 以及基本的血细胞完整性测试，以有一个初步的安全性评估建议 技术

Project Summary Around 400,000 patients in the US and at least 5 million world-wide, receive weekly sessions of hemodialysis (HD), the standard long-term treatment for irreversible kidney failure. Although it has revolutionized the field by increasing the longevity of patients, improvements in the technique and equipment have been stagnant for decades. Besides from still suffering from high premature mortality rate compared to the general population, HD patients carry a high burden symptomatology which requires frequent hospitalizations and significantly deteriorate the patient’s overall quality of life. It is agreed upon that a major contributor to the patients’ symptom burden arises from the HD treatment itself. The main difficulty in identifying and eliminating bio-stressors that arise from the HD treatment is that most of them appear to be minute low intensity imperfections of the procedure that only cause health problems because of the frequent and cumulative exposure time (>600hrs/year) to which HD patients are subjected to. One of these stressors considered as an unavoidable hazard of the HD treatment is air microbubble infusion. Microbubble infusion by HD affects mostly the lungs- causing endothelial damage, atherosclerosis, pulmonary vascular remodeling, and dyspnea- but have also been found in the heart and brain of patients. There is currently no technique or technology capable of eliminating from HD the majority of microbubbles of sizes below 100 µm. SIL Technologies is proposing an acoustically expedited microbubble diffusion technology that would eliminate most, if not all, microbubbles present in the extracorporeal tubing of HD equipment. The proposed technology uses acoustic forcing to “push” microbubbles against the wall of a silicone tube which is gas permeable. The silicone tube is surrounded by degassed water. The combination of acoustic forcing and gas concentration difference (between air bubble and degassed water) provide a strong diffusion driving force, capable of working even through thick membranes (thicknesses larger than 0.5 mm). We expect to prove the feasibility of the technology by completing the following specific aims: i) An acoustic resonance chamber will be designed to maximize the acoustic force and bubble-diffusion anchoring sites by finite-element simulations. ii) The device designed in i) will be constructed and in-line installed to a fluid circuit powered by a peristaltic pump and filled with a transparent blood mimicking fluid. Pulse-Doppler microbubble counters will be placed at the entrance and exit sites of the device to collect the necessary data to determine the effectiveness of the concept. And finally, iii) the fluid circuit will be filled with real blood and the experiments carried out in ii will be repeated. A statistical analysis of the effectiveness of the device operating on blood will be determined as well as basic blood cell integrity tests to have a preliminary safety assessment of the proposed technology.