Apical Access System with Universal Connector for Beating Heart LVAD Implantation

带有用于跳动心脏 LVAD 植入的通用连接器的心尖接入系统

基本信息

批准号：
8454767
负责人：
Jorge Hernan Jimenez
金额：
$ 52.57万
依托单位：
APK ADVANCED MEDICAL TECHNOLOGIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-03-01 至 2014-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8454767
关键词：
Acute Adoption Adverse event Air Animal Experiments Animal Testing Animals Apical Biomedical Engineering Blood Blood donor Cadaver Cannulas Cardiopulmonary Bypass Cardiovascular system Caring Cattle Cells China Chronic Clinical Clinical Engineering Clinical Trials Computer Simulation Coupling Development Devices Disease Engineering Exposure to Extravasation Fatigue Finite Element Analysis Freezing Future Goals Government Agencies Health Healthcare Healthcare Systems Heart Heart Transplantation Heart failure Hemorrhage Hemostatic Agents Hospitals Human Implant India Institutes Intervention Lead Left Left ventricular structure Legal patent Marketing Measurable Medical Medical Technology Metric Modeling Morbidity - disease rate Myocardium Operative Surgical Procedures Outcome Patients Phase Postoperative Period Procedures Quality of life Recovery Research Personnel Resources Retrieval Risk Role Safety Secure Small Business Innovation Research Grant Spatial Distribution Staging Sterilization Study models Surgical incisions Surgical sutures Suture Techniques System Techniques Technology Testing Time Translating Treatment Cost Underserved Population Validation biomaterial compatibility clinical practice commercialization cost design follow-up good laboratory practice implantation improved in vivo innovation meetings miniaturize minimally invasive mortality outcome forecast pre-clinical prevent product development prototype public health relevance seal tool ventricular assist device verification and validation

项目摘要

DESCRIPTION (provided by applicant): The objective of this proposal is to complete development of a long-term, universal Apical Access System (AAS) to improve clinical outcomes and expand the role of left ventricular assist device (LVAD) therapy. The treatment of end stage heart failure (HF) is the greatest challenge, both clinically and economically to the U.S. health care system today. With >800,000 people suffering with end stage HF and only 2,300 heart transplants and 4,600 LVADs implanted annually there is large a population underserved. LVAD implantation requires a major operative procedure with significant peri- and post-operative bleeding complications, mortality, and treatment costs. APK Advanced Medical Technologies, Inc. AAS System will allow current LVADs and future "Mini-VADs" to be implanted suture-less through a minimally invasive incision without placing the patient on cardiopulmonary bypass (CPB). By eliminating CPB, reducing access time and reducing bleeding, a significant and measurable impact on patient health and procedural cost will be achieved. The different components of the AAS System have been tested previously on the bench, in FEA computational models, and through acute and chronic (up to 12 weeks) animal experiments with positive results. The specific aims of the current proposal are: Phase I-Aim 1: Complete fabrication of the integrated components for the re-designed AAS System and demonstrate feasibility for LVAD therapy in acute bovine model (n=2) and human cadaver (n=2). Phase II-Aim 1: Complete the engineering development and design freeze of the LVAD AAS in compliance with Good Manufacturing Practices (GMP) specifications for a human implant quality system. Aim 2: Demonstrate safety and efficacy of the AAS System by completing risk analysis driven validation and verification testing. Testing to include: 600 Millio cycle fatigue, leakage/burst testing in pressurized hearts, Finite element analysis of anchoring components, sterilization validation and biocompatibility, anatomical fit and surgical procedure study (human cadaver, n=8), and in vivo acute (n=6), 14-day (n=6), and 30-day (n=6) in a chronic bovine model with HM II (Thoratec) and HVAD (HeartWare) devices. Successful outcomes will be quantified by metrics to include; incision size, ease of use, implantation time, blood loss, durability (fatigue on clinical-grade components), need for CPB, conformance to biocompatibility and sterilization ISO standards, and secure connection without air entrainment or leakage. Aim 3: Demonstrate long-term safety and reliability of the LVAD AAS in 30-day pre-GLP (n=2) and GLP (n=4) chronic bovine model study to support an IDE application for a clinical trial in patients with advanced heart failure receiving LVAD implantation only. The successful execution of this SBIR project will lead to development of a new clinical paradigm in the treatment of HF. Specifically the AAS will reduce surgical complexity and make LVAD therapy affordable leading to improved patient outcomes and quality of life. Ultimately, clinical acceptance to treat earlier stage HF patients and expansion into global markets can be achieved.

描述（由申请人提供）：该提案的目的是完整开发长期的普遍顶端接入系统（AAS），以改善临床结果并扩大左心室辅助设备（LVAD）治疗的作用。当今，在临床和经济上，终结阶段心力衰竭（HF）的治疗是当今美国医疗保健系统的最大挑战。 > 800,000人患有终阶段HF，只有2,300次心脏移植和4,600 LVAD植入，每年植入大量人口。 LVAD植入需要进行重大的手术程序，并具有明显的术后出血并发症，死亡率和治疗成本。 APK Advanced Medical Technologies，Inc。AAS系统将允许当前的LVAD和未来的“迷你vads”通过微创切口植入无缝合线，而无需将患者放置在心肺旁路（CPB）上。通过消除CPB，减少访问时间并减少出血，将对患者的健康和程序成本产生重大且可衡量的影响。 AAS系统的不同组件先前已经在台式上，FEA计算模型以及急性和慢性（长达12周）动物实验中进行了测试，并取得了阳性结果。当前建议的具体目的是：I-AIM 1：为重新设计的AAS系统的集成组件的完整制造，并证明了急性牛模型（n = 2）和人尸体（n = 2）的LVAD治疗可行性。 II-II-AIM 1：根据人类植入质量系统的良好制造实践（GMP）规格，完成了LVAD AAS的工程开发和设计冻结。目标2：通过完成风险分析驱动验证和验证测试来证明AAS系统的安全性和功效。测试包括：600毫入循环疲劳，加压心脏中的泄漏/爆发测试，锚定成分的有限元分析，灭菌验证和生物相容性，解剖结构拟合和手术程序研究（人尸体，n = 8）以及体内急性（n = 6），14天（n = 6），n = 6），n = 6 = 6）（Thoratec）和HVAD（Heartware）设备。成功的结果将通过指标量化；切口大小，易用性，植入时间，失血，耐用性（临床级成分的疲劳），需要CPB，符合生物相容性和灭菌ISO标准，以及没有空气夹带或泄漏的安全连接。目标3：证明LVAD AAS在30天前GLP（n = 2）和GLP（n = 4）慢性牛模型研究中的长期安全性和可靠性，以支持仅接受LVAD植入LVAD植入的晚期心力衰竭患者的IDE应用。该SBIR项目的成功执行将导致在HF治疗中开发新的临床范式。特别是AAS将降低手术复杂性，并使LVAD疗法负担得起，从而改善了患者的结果和生活质量。最终，可以实现治疗早期HF患者并扩展到全球市场的临床接受。