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

• 批准号: 8607819
• 负责人: Lakshmi Prasad Dasi
• 金额: $ 12.32万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-25 至 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8607819
• 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; 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; Solutions; 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; minimally invasive; nanoengineering; next generation; novel; operation; patient population; preclinical study; preference; pressure; professor; programs; public health relevance; response; shear stress; tissue fixing

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：所有当今的假肢心脏瓣膜都存在有关血液兼容性和血栓栓塞并发症风险的问题。印度的低成本Chitra机械心脏瓣膜需要强大的终身抗癌疗法是目前唯一适应印度主要年轻心脏瓣膜患者的瓣膜。因此，大多数印度患者别无选择，只能面对寿命长的抗癌疗法的风险。生物周期心脏瓣膜要么太昂贵，要么患者不希望将这些瓣膜耐用性相对较差和印度医院的高感染率继发于相对较差的前景。此外，存在与使用猪或牛组织有关的个人宗教偏爱引起的。由于患者的年龄以及更严重的耐用性问题，在美国，最小侵入性技术的最新发展对印度没有吸引力。需要的是低成本非组织的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旋转心脏瓣膜。我们的实验室已经开发了一种新型的生物材料生物聚糖，其中涉及在分子水平的聚合物材料的工程化，该聚合物材料与透明质酸（HA，一种天然存在的多糖）相互关联，以使高度水生活性血液和生物兼容的血液和生物兼容的聚合物与工程构成的Polimersers的耐用性。初步工作表明，与普通的聚合物小叶相比，生物多的小叶具有明显的血液兼容。此外，我们已经证明了将生物多叶小叶组装成具有出色的血液动力学特征的植入三叶瓣体假体的可行性。目前的R03研究旨在测试和优化生物阀作为下一代低成本和上级心脏瓣膜。我们的中心假设是：生物聚集是一种有效且低成本的生物材料，用于三叶心脏瓣膜假体，仅使用阿司匹林方案抗凝治疗。这在三个目标中进行了测试。 AIM 1专注于新阀的血流动力和耐用性测试，同时优化传单套的特征。 AIM 2专注于优化材料制造工艺，以最大程度地提高这些瓣膜的血液兼容。 AIM 3的重点是开始动物试验，以验证体内的血液相容性和钙化，并为印度的商业化奠定了基础。这些研究是由美国和印度团队与我们的商业合作伙伴TTK Healthcare合作进行的。 TTK Healthcare是印度的主要阀门制造商，致力于将我们的低成本技术商业化，以迎合印度市场。我们的方法是使用HA的创新性，它是将血液兼容带到其他不兼容，耐用的疏水聚合物小叶中的药物，具有在低成本和高设计耐受性下朝着质量产生扩展的潜力。