Development of a Partial Occlusion Device to Aid in Coring and Anastomsis of the Aorta
Development of a Partial Occlusion Device to Aid in Coring and Anastomsis of the Aorta
批准号:
10010033
负责人:
Landon Heath Tompkins
金额:
$27.85万
依托单位国家:
美国
项目类别:
财政年份:
2020
资助国家:
美国
项目状态:
已结题
起止时间:
2020-08-21 至 2022-08-20
关键词:
Anastomosis - actionAnimal ModelAortaAreaBalloon OcclusionBlood VesselsCadaverCaliberCardiopulmonary BypassCardiovascular systemCathetersCause of DeathCessation of lifeClinicalClinical TrialsClosure by clampCoupledCustomDataDevelopmentDevice DesignsDevicesDissectionDistalDropsEmbolismEngineeringEnvironmentFamily suidaeFreezingGoalsHeartHeart TransplantationHeart failureHemostatic AgentsHemostatic functionHumanImplantImplantation procedureIncidenceInstitutesInvestigationLength of StayLiquid substanceMechanicsModelingMonitorOperative Surgical ProceduresOutcomePatient-Focused OutcomesPatientsPerfusionPhasePolyestersPolyurethanesPositioning AttributePreclinical TestingProceduresPumpQuality of lifeRecoveryResearch PersonnelRiskSafetySiliconesSmall Business Innovation Research GrantStentsSternotomyStructureStudy modelsSurgeonSystemTechniquesTechnologyTestingThoracotomyTissuesTranslatingUnited States Food and Drug AdministrationUnited States National Institutes of HealthUniversitiesVisualizationWorkalternative treatmentarmascending aortaaxillary arterybaseblood perfusioncalcificationclinical practiceclinically relevantdesigngood laboratory practiceimplantable deviceimplantationimprovedin vitro testinginnovationleft ventricular assist deviceminimally invasivemortalitynovelpatient populationphase 2 studypressureprototypesealtoolverification and validation
中文摘要
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
英文摘要
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.
期刊论文(3)
专著(0)
科研奖励(0)
会议论文
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)
影响因子:
--
作者:
[Monreal,Gretel, Koenig,StevenC, Taskin,MustafaErtan, ShambaughJr,Charles, LaRose,JeffreyA, Slaughter,MarkS]
通讯作者:
Slaughter,MarkS
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.
海外基金