Innovative technology for elimination of microbubbles during hemodialysis treatments

血液透析治疗过程中消除微泡的创新技术

• 批准号: 10546568
• 负责人: Manuel Rivera
• 金额: $ 15万
• 依托单位: SIL TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10546568
• 关键词: Acoustics; Address; Affect; Air; Air Embolism; Atherosclerosis; Attention; Behavior; Blood; Blood Cells; Blood Circulation; Blood Platelets; Blood Vessels; Blood flow; Blood specimen; Brain; Cells; Clinical; Closure by clamp; Data; Data Analyses; Decompression Sickness; Device Designs; Devices; Diffuse; Diffusion; Dyspnea; Elements; Embolism; Endothelium; Equipment; Exposure to; Gases; General Population; Health; Heart; Hematological Disease; Hemodialysis; Hospitalization; Hour; Iatrogenesis; In Vitro; Infusion procedures; Intervention; Kidney Failure; Knowledge; Laws; Liquid substance; Longevity; Lung; Medical; Membrane; Methodology; Microbubbles; Minor; Monitor; Morbidity - disease rate; Operative Surgical Procedures; Patients; Permeability; Phase; Physiologic pulse; Platelet aggregation; Population; Positioning Attribute; Premature Mortality; Procedures; Process; Pump; Quality of life; Research; Safety; Silicon; Silicones; Site; Statistical Data Interpretation; Surface; Symptoms; System; Techniques; Technology; Testing; Thick; Time; Transducers; Tube; Validation; Venous; Water; design; driving force; effectiveness analysis; effectiveness evaluation; experimental study; feasibility testing; hazard; innovation; innovative technologies; medical specialties; phase 1 testing; prototype; pulmonary vascular remodeling; safety assessment; side effect; simulation; stressor; symptomatology; technology diffusion

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.

项目摘要 美国约有40万患者，全球至少有500万患者每周接受血液透析 (HD)，不可逆肾衰竭的标准长期治疗。尽管它已经彻底改变了这个领域， 为了延长病人的寿命，技术和设备的改进一直停滞不前， 几十年除了与普通人群相比仍然遭受高过早死亡率之外， 患者承受着高负担的外科学，这需要频繁住院， 降低患者的整体生活质量。人们一致认为，患者症状的主要原因 负担来自HD治疗本身。识别和消除生物应激源的主要困难是， 从HD治疗中产生的是，它们中的大多数似乎是程序的微小低强度缺陷 这只会导致健康问题，因为频繁和累积的接触时间（> 600小时/年）， HD患者会受到。这些应激源之一被认为是HD治疗不可避免的危险 是空气微泡注入。通过HD输注微泡主要影响肺-引起内皮损伤， 动脉粥样硬化，肺血管重塑和呼吸困难-但也发现在心脏和大脑 病人。目前还没有技术或技术能够从HD中消除大部分的 微气泡的尺寸小于100 µm。SIL技术公司提出了一种声学加速微泡 扩散技术，将消除大多数，如果不是全部，存在于体外管路中的微泡， 高清设备。所提出的技术使用声学强制将微泡“推”到 可透气硅树脂管。硅胶管被脱气水包围。的组合 声强迫和气体浓度差（气泡和脱气水之间）提供了强的 扩散驱动力，甚至能够通过厚膜（厚度大于0.5 mm）工作。我们 我希望通过完成以下具体目标来证明该技术的可行性： 共振室将被设计成最大化声学力和气泡扩散锚定位置， 有限元模拟ii）i）中设计的装置将被构造并在线安装到流体回路 由蠕动泵提供动力并充满透明的血液模拟流体。脉冲多普勒微泡 计数器将放置在设备的入口和出口处，以收集必要的数据， 概念的有效性。最后，iii）流体回路将充满真实的血液， 将重复在第二阶段进行的工作。对器械在血液上运行的有效性进行统计分析， 以及基本的血细胞完整性测试，以进行初步的安全性评估 技术.