Novel Biomimetic Coating for Circulatory Devices

用于循环装置的新型仿生涂层

• 批准号: 7287781
• 负责人: JAN JERZY LEWANDOWSKI
• 金额: $ 106.61万
• 依托单位: ELECTROSONICS MEDICAL INC.
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-06 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7287781
• 关键词: Adsorption; Adverse effects; Affect; Anaphylaxis; Animal Model; Applications Grants; Attention; Award; Biological; Biomimetics; Blood; Blood Coagulation Disorders; Blood Platelets; Blood typing procedure; Bos taurus; Cardiac Surgery procedures; Cardiopulmonary; Cardiopulmonary Bypass; Cattle; Cerebrum; Clinical Research; Coagulation Process; Compatible; Complement; Data; Devices; Effectiveness; Evaluation; Family suidae; Fibrinolysis; Functional disorder; Gases; Goals; Guidelines; Heart; Hemolysis; Heparin; Human; In Vitro; Inflammatory Response; Investigation; Kidney; Leukocytes; Life; Literature; Lung; Medical Device; Membrane; Membrane Oxygenators; Modeling; Numbers; Operative Surgical Procedures; Oxygenators; Patients; Performance; Phase; Physiological; Polymers; Process; Production; Property; Pump; Purpose; Rate; Recommendation; Recovery; Reporting; Research; Research Personnel; Risk; Safety; Screening procedure; Sleep Disorders; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Standards of Weights and Measures; Support System; Surface; Surgical complication; Sus scrofa; System; Testing; Time; Toxic effect; Toxicity Tests; Treatment Cost; United States Food and Drug Administration; base; biomaterial compatibility; blood pump; cost; design; hemodynamics; improved; in vivo; neutrophil; novel; prevent; programs; respiratory assist; surfactant; ventricular assist device

DESCRIPTION (provided by applicant): Circulatory and respiratory assist devices, such as cardiopulmonary bypass circuits (CPB), ventricular assist devices (VAD's) and blood membrane (ECMO's) are routinely used in cardiac surgery and to support patient impaired physiological functions. Inadequate biocompatibility of foreign surfaces contacting the patient's blood contributes to the activation of blood proteolytic systems such as coagulation, complements, fibrinolysis and also activates cellular blood components. This can result in a potentially life threatening systemic inflammatory response. BIOMEC has developed a novel and promising type of surfactant polymer coating (SPC), which can be used to substantially improve the biocompatibility of these devices. As a result of our Phase II SBIR effort, BIOMEC has improved the process of surfactant polymer synthesis, which allows for reproducible production of larger volumes of the material necessary for extensive coating and testing. In vitro performance of SPC coated blood pumps in human blood was compared to the uncoated pumps (negative control) and to heparin coated pumps (positive control). We demonstrated that SPC prevents surface platelet and neutrophils adsorption with efficacy at least equivalent and generally better than heparin coating. The surfactant coating also significantly lowers the hemolysis rate in comparison to heparin-coated pumps. Preliminary toxicity testing and in vivo studies (pig model) indicate that the coating is biologically safe and does not affect the pump hemodynamic performance. An additional advantage of SPC over heparin coatings is its extreme simplicity of application to existing commercial devices, and hence its low cost. In this project phase we propose to continue biological safety evaluation of SPC according to FDA requirements. Further, upon approval of an Investigational Device Exemption we will conduct a pilot clinical study to conclusively demonstrate the in vivo safety and effectiveness of SPC coated cardiopulmonary bypass circuit. As the result of these efforts, BIOMEC will have developed an effective yet inexpensive blood compatible coating for blood contacting devices.

描述（由申请人提供）： 循环和呼吸辅助装置，例如心肺旁路回路（CPB）、心室辅助装置（VAD）和血膜（ECMO）通常用于心脏手术并支持患者受损的生理功能。接触患者血液的异物表面的生物相容性不足会导致血液蛋白水解系统的激活，例如凝血、补体、纤维蛋白溶解，并且还会激活细胞血液成分。这可能导致潜在危及生命的全身炎症反应。 BIOMEC 开发了一种新型且有前景的表面活性剂聚合物涂层 (SPC)，可用于大幅提高这些设备的生物相容性。由于我们第二阶段 SBIR 的努力，BIOMEC 改进了表面活性剂聚合物合成工艺，从而可以重复生产大量涂层和测试所需的材料。 将 SPC 涂层血泵在人体血液中的体外性能与未涂层泵（阴性对照）和肝素涂层泵（阳性对照）进行比较。我们证明，SPC 可以防止表面血小板和中性粒细胞吸附，其功效至少与肝素涂层相当，并且通常更好。与肝素涂层泵相比，表面活性剂涂层还显着降低了溶血率。初步毒性测试和体内研究（猪模型）表明该涂层具有生物安全性，不会影响泵的血流动力学性能。与肝素涂层相比，SPC 的另一个优点是其在现有商业设备上的应用极其简单，因此成本较低。 在本项目阶段，我们建议根据FDA的要求继续对SPC进行生物安全性评价。此外，在研究设备豁免获得批准后，我们​​将进行一项试点临床研究，以最终证明 SPC 涂层心肺旁路回路的体内安全性和有效性。作为这些努力的结果，BIOMEC 将为血液接触装置开发出一种有效且廉价的血液相容涂层。

项目成果

In vivo evaluation of a new surfactant polymer coating mimicking the glycocalyx of endothelial cells.

模拟内皮细胞糖萼的新型表面活性剂聚合物涂层的体内评估。

• DOI: 10.1097/mat.0b013e318229ac9c
• 发表时间: 2011
• 期刊: ASAIO journal (American Society for Artificial Internal Organs : 1992)
• 作者: Shiose,Akira;Takaseya,Tohru;Kim,Hyun-Il;Kobayashi,Mariko;Horai,Tetsuya;Rao,Santosh;Arakawa,Yoko;Fujiki,Masako;McCarthy,MarkA;Liu,Yubiao;Lewandowski,JanJ;Davis,Amy;Fukamachi,Kiyotaka
• 通讯作者: Fukamachi,Kiyotaka