Cost Effective Trileaflet BioPolymeric Heart Valve For India

印度具有成本效益的三叶生物聚合心脏瓣膜

基本信息

批准号：
9147571
负责人：
Lakshmi Prasad Dasi
金额：
$ 12.05万
依托单位：
OHIO STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-09-25 至 2018-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9147571
关键词：
Adhesions Adolescent Adsorption Age Animals Anticoagulation Area Artificial Heart Aspirin Biocompatible Biocompatible Materials Biomechanics Bioprosthesis device Blood Blood Platelets Blood Vessels Blood coagulation Cardiovascular Surgical Procedures Cardiovascular system Cattle Characteristics Charge Chitra Clinical Trials Coagulation Process Collaborations Data Development Devices Disease Effectiveness Engineering Entrepreneurship Environment Face Family suidae Fatigue Female of child bearing age Fibrinogen Goals Health Healthcare Healthcare Market Heart Valve Prosthesis Heart Valves Hospitals Human Hyaluronan In Vitro India Infection Inferior Institutes Joints Kinetics Knowledge Length Leukocytes Life Liquid substance Manufacturer Name Marketing Measures Mechanics Medical Molecular Operative Surgical Procedures Orthopedics Pathologist Patients Performance Plasma Platelet Activation Polyethylenes Polymers Polysaccharides Production Property Prosthesis Regimen Religion and Spirituality Research Research Personnel Risk Safety Science Scientist Secondary to Sheep Surface Surgeon Technology Technology Transfer Testing Thrombosis Time Tissues Translating United States Validation Whole Blood Work age group animal facility antithrombin III-protease complex authority base biomaterial compatibility calcification commercialization cost cost effective crosslink cytotoxicity density design experience flexibility hemodynamics improved in vitro testing in vivo innovation manufacturing process member mid-career faculty minimally invasive nanoengineering next generation novel operation patient population pre-clinical trial preference pressure programs response shear stress tissue fixing

项目摘要

DESCRIPTION: All present day prosthetic heart valves have issues regarding blood compatibility and risk of thromboembolic complications. India's low cost Chitra mechanical heart valve that requires strong life-long anti-coagulation therapy is the only valve that presently caters to the predominantly young heart valve patient in India. Therefore, most Indian patients have no choice but to face the risks of life long anti-coagulation therapy. Bio-prosthetic heart valves are either too expensive or the patients do not prefer the prospect of re-operation secondary to relatively poor durability of these valves and high rate of infection in Indian hospitals. Further there exists concern arising from personal religious preference related to use of porcine or bovine tissue. Recent development of minimally invasive technology in the United States is not as attractive to India due to the patient age, and more severe durability concerns. What is needed is a low-cost non-tissue based biocompatible tri-leaflet heart valve. Polymeric heart valves have the promise to bring the best of mechanical valves and bio-prosthetic heart valves. Our lab has developed a novel biomaterial, Bio-Poly, which involves the engineering of polymeric materials that are, at a molecular level, interlocked with hyaluronan (HA, a naturally occurring polysaccharide) to make highly hydrophilic hemo- and bio-compatible polymer leaflets with the durability of engineered synthetic polymers. Preliminary work has shown that Bio-Poly leaflets have a remarkably hemo-compatible compared to plain polymer leaflets. Further, we have already demonstrated the feasibility of assembling Bio-Poly leaflets into implantable tri-leaflet valve prosthesis with excellent hemodynamic characteristics. The present R03 study aims to test and optimize Bio-Poly valves as the next generation low-cost and superior heart valve. Our central hypothesis is: that Bio-poly is an effective and low-cost biomaterial for tri-leaflet heart valve prosthesis with aspirin regimen anticoagulation only. This is tested in three aims. Aim 1 focuses on hemodynamic and durability testing of the new valves while optimizing leaflet cooptation characteristics. Aim 2 focuses on optimizing the materials manufacturing process to maximize hemo-compatibility of these valves. Aim 3 focuses on commencing animal trials to validate hemocompatibility and calcification in vivo and lay the groundwork for commercialization in India. These studies are jointly conducted by the US and Indian teams in collaboration with our commercial partner, TTK Healthcare. TTK Healthcare is a major valve manufacturer in India that is committed to commercialize our low-cost technology to cater to the Indian market. Our approach is innovative with the use of HA, as the agent that brings hemo-compatibility to otherwise non-compatible, durable hydrophobic polymer leaflets that have the potential for scaling towards mass production at low-cost and high design tolerance.

描述：目前所有的人工心脏瓣膜都存在血液相容性和血栓栓塞并发症风险方面的问题。印度低成本的 Chitra 机械心脏瓣膜需要终生强力抗凝治疗，是目前唯一适合印度年轻心脏瓣膜患者的瓣膜。因此，大多数印度患者别无选择，只能面临终生抗凝治疗的风险。生物人工心脏瓣膜要么过于昂贵，要么由于这些瓣膜的耐用性相对较差以及印度医院的感染率较高，患者不希望再次手术。此外，还存在与使用猪或牛组织相关的个人宗教偏好引起的担忧。由于患者年龄和更严重的耐用性问题，美国最近发展的微创技术对印度没有那么有吸引力。所需要的是一种低成本的非组织基生物相容性三叶心脏瓣膜。聚合物心脏瓣膜有望带来最好的机械瓣膜和生物假体心脏瓣膜。我们的实验室开发了一种新型生物材料 Bio-Poly，它涉及高分子材料的工程设计，这些材料在分子水平上与透明质酸（HA，一种天然存在的多糖）互锁，以制造高度亲水性的血液和生物相容性聚合物小叶具有工程合成聚合物的耐用性。初步研究表明，与普通聚合物小叶相比，Bio-Poly 小叶具有显着的血液相容性。此外，我们已经证明了将 Bio-Poly 小叶组装成具有优异血流动力学特性的植入式三叶瓣膜假体的可行性。目前的 R03 研究旨在测试和优化 Bio-Poly 瓣膜作为下一代低成本优质心脏瓣膜。我们的中心假设是：Bio-poly 是一种有效且低成本的生物材料，用于仅使用阿司匹林方案抗凝的三叶心脏瓣膜假体。这是在三个目标上进行测试的。目标 1 重点关注新瓣膜的血流动力学和耐久性测试，同时优化瓣叶配合特性。目标 2 侧重于优化材料制造工艺，以最大限度地提高这些瓣膜的血液相容性。目标 3 侧重于开始动物试验，以验证体内血液相容性和钙化，并为在印度的商业化奠定基础。这些研究由美国和印度团队与我们的商业合作伙伴 TTK Healthcare 合作共同进行。 TTK Healthcare 是印度一家主要的阀门制造商，致力于将我们的低成本技术商业化，以满足印度市场的需求。我们的方法是创新的，使用HA作为一种试剂，为原本不相容的耐用疏水性聚合物小叶带来血液相容性，这些小叶有可能以低成本和高设计公差进行大规模生产。