Development of a Partial Occlusion Device to Aid in Coring and Anastomsis of the Aorta

开发部分闭塞装置以辅助主动脉的取芯和吻合术

• 批准号: 10010033
• 负责人: Landon Heath Tompkins
• 金额: $ 27.85万
• 依托单位: MYOCARDIAL ASSIST SYSTEMS AND TECHNOLOGY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-21 至 2022-08-20
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10010033
• 关键词: Anastomosis - action; Animal Model; Aorta; Area; Balloon Occlusion; Blood Vessels; Cadaver; Caliber; Cardiopulmonary Bypass; Cardiovascular system; Catheters; Cause of Death; Cessation of life; Clinical; Clinical Trials; Closure by clamp; Coupled; Custom; Data; Development; Device Designs; Devices; Dissection; Distal; Drops; Embolism; Engineering; Environment; Family suidae; Freezing; Goals; Heart; Heart Transplantation; Heart failure; Hemostatic Agents; Hemostatic function; Human; Implant; Implantation procedure; Incidence; Institutes; Investigation; Length of Stay; Liquid substance; Mechanics; Modeling; Monitor; Operative Surgical Procedures; Outcome; Patient-Focused Outcomes; Patients; Perfusion; Phase; Polyesters; Polyurethanes; Positioning Attribute; Preclinical Testing; Procedures; Pump; Quality of life; Recovery; Research Personnel; Risk; Safety; Silicones; Small Business Innovation Research Grant; Stents; Sternotomy; Structure; Study models; Surgeon; System; Techniques; Technology; Testing; Thoracotomy; Tissues; Translating; United States Food and Drug Administration; United States National Institutes of Health; Universities; Visualization; Work; alternative treatment; arm; ascending aorta; axillary artery; base; blood perfusion; calcification; clinical practice; clinically relevant; design; good laboratory practice; implantable device; implantation; improved; in vitro testing; innovation; left ventricular assist device; minimally invasive; mortality; novel; patient population; phase 2 study; pressure; prototype; seal; tool; verification and validation

Heart failure (HF) accounts for 1 in 4 deaths in the US each year, making it the leading cause of death with a HF patient population of over 6.5 million people. Due to a scarcity of donor hearts, left ventricular assist devices (LVADs) have gained clinical acceptance as an alternative treatment option to heart transplantation due to their durability and long-term viability. Improved survival and reduced mortality have been associated with less invasive and off-pump approaches. Current clinically-approved LVADs require aortic partial clamping to facilitate outflow graft anastomosis and may also require cross-clamping of the aorta and cardiopulmonary bypass (CPB) during LVAD implantation. To improve clinical outcomes, MAST LLC (Louisville, KY) is developing a two-balloon partial occlusion device (CardiAction) designed to provide a safe, reliable, and effective hemostatic field that allows for the anastomosis of an LVAD outflow graft without the need for external clamping. The CardiAction system internally occludes the ascending aorta (clamping), creating a hemostatic pocket for which an anastomosis can be placed, while still allowing vessel perfusion (up to 5 L/min flow, < 5 mmHg) without vessel tissue damage. CardiAction is a catheter-based system comprised of a balloon-stent structure, multi-lumen conduit, and a delivery sheath. The balloon-stent structure, which consists of two polyurethane, toroidal balloons positioned on the ends of a woven-polyester covered self-expanding and collapsible stent, will provide aortic occlusion enabling the perfusion through the device lumen. The balloons are inflated until sufficient vessel wall contact is achieved, creating a static environment between the balloons. The multi-lumen conduit and delivery sheath will assist in device placement, deployment, and retraction. The proposed tool will be a less invasive 18Fr sheath catheter-based solution. The stent cover provides a central lumen for perfusion, eliminating risks associated with complete vessel occlusion. The inflated balloons provide intravascular occlusion that maintains the natural vascular structure, thereby creating a static environment that will provide the surgeon with a leak-free area to operate on the vessel while also reducing the potential for tissue damage. In this SBIR phase I proposal, we will demonstrate feasibility of the CardiAction system, and then plan to submit a phase II proposal to complete engineering development to achieve a design freeze of the CardiAction system and complete pre-clinical testing to demonstrate efficacy, safety, and reliability. The phase II experimental data will be used to support an Investigational Device Exemption (IDE) application to the Food and Drug Administration (FDA) for clinical trials.

在美国，每年有四分之一的人死于心力衰竭（HF），使其成为心脏病的主要死因

项目成果

Development of Inspired Therapeutics Pediatric VAD: Benchtop Evaluation of Impeller Performance and Torques for MagLev Motor Design.

• DOI: 10.1007/s13239-021-00578-z
• 发表时间: 2022-04
• 期刊: Cardiovascular engineering and technology
• 影响因子: 1.8
• 作者: Tompkins LH;Prina SR;Gellman BN;Morello GF;Roussel T;Kopechek JA;Williams SJ;Petit PC;Slaughter MS;Koenig SC;Dasse KA
• 通讯作者: Dasse KA

Feasibility Testing of the RT Cardiac Systems Percutaneous Mechanical Circulatory Support Device.

RT 心脏系统经皮机械循环支持装置的可行性测试。

• DOI: 10.1097/mat.0000000000001887
• 发表时间: 2023
• 期刊: ASAIO journal (American Society for Artificial Internal Organs : 1992)
• 作者: Monreal,Gretel;Koenig,StevenC;Taskin,MustafaErtan;ShambaughJr,Charles;LaRose,JeffreyA;Slaughter,MarkS
• 通讯作者: Slaughter,MarkS

Feasibility testing of the Inspired Therapeutics NeoMate mechanical circulatory support system for neonates and infants.

• DOI: 10.1371/journal.pone.0266822
• 发表时间: 2022
• 期刊: PLOS ONE
• 影响因子: 3.7
• 作者: Monreal, Gretel;Koenig, Steven C.;Slaughter, Mark S.;Morello, Gino F.;Prina, Steven R.;Tompkins, Landon H.;Huang, Jiapeng;Gellman, Barry N.;Dasse, Kurt A.
• 通讯作者: Dasse, Kurt A.