Intravenous delivery of oxygen microbubbles for the treatment of hypoxia and ARDS
静脉输送氧气微泡治疗缺氧和急性呼吸窘迫综合征
基本信息
- 批准号:10384013
- 负责人:
- 金额:$ 30.55万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-09-20 至 2024-08-31
- 项目状态:已结题
- 来源:
- 关键词:AcuteAcute Lung InjuryAcute Respiratory Distress SyndromeAcute myocardial infarctionAdoptionAdverse effectsAffectAirAlveolarAnimalsBeakBehaviorBiocompatible MaterialsBloodBlood CirculationBypassCOVID-19CannulasCarbon DioxideCardiacCardiopulmonaryCardiovascular systemCatastrophic IllnessCathetersCell Membrane PermeabilityChargeChemicalsChinaChronic DiseaseChronic Obstructive Pulmonary DiseaseClinicalCongestive Heart FailureContinuous InfusionContinuous Positive Airway PressureCritical IllnessDangerousnessDevelopmentDevicesDiagnosticDiffuseDiffusionDoseDysbarismEffectivenessEmbolismExtracorporeal Membrane OxygenationFDA approvedFamily suidaeFemoral veinFluid overloadFutureGasesGoalsHeartHeart failureHourHypercapniaHypoxemiaHypoxemic Respiratory FailureHypoxiaIatrogenesisInferior vena cava structureInfusion PumpsInfusion proceduresInjectionsIntravenousIschemic StrokeKnowledgeLiquid substanceLungMeasuresMechanical ventilationMechanicsMetabolicMetalsMethodsMicrobubblesModelingMyocardialMyocardial InfarctionNitrogen DioxideNoseOxygenPatientsPeripheralPhasePhysiologicalPractice ManagementPre-Clinical ModelProceduresPropertyPulmonary FibrosisRampRenal functionSafetySample SizeScientistSeptic ShockSheepSurfaceSystemSystems DevelopmentTechniquesTechnologyTestingTherapeuticTissuesTranslatingTreatment EfficacyVariantabsorptionalternative treatmentclinical practicecostcritical limb Ischemiaeffective therapyhemocompatibilityhemodynamicshigh riskhyperbaric chamberimprovedimproved outcomein vitro Modelin vivoinnovationlung injuryminimally invasivenormoxianoveloxygen toxicityporcine modelpreclinical studypressurepreventprototyperespiratory assistrisk minimizationsuccessultrasound
项目摘要
PROJECT SUMMARY
The goal of this Phase 1 project is to develop the AS-O2-001 System for intravenous, gaseous oxygen
microbubble delivery for treatment of hypoxia. Hypoxia is a catastrophic illness that can result from acute
respiratory distress syndrome (ARDS), chronic obstructive pulmonary disease (COPD), pulmonary fibrosis,
COVID-19, congestive heart failure and myocardial infarction. Current treatment options for severely affected
patients include extracorporeal membrane oxygenation (ECMO) and mechanical ventilation, which are both
invasive, expensive, and have iatrogenic sequalae. Agitated Solutions Inc. is developing a novel, minimally
invasive alternative: the AS-O2-001 system delivers gaseous oxygen microbubbles into the inferior vena cava to
delay or prevent mechanical ventilation or ECMO.
Gaseous oxygen delivery has historically resulted in emboli formation; however, improved technology today
enables the delivery of microbubbles (<100 µm). Microbubbles have unique properties, including their shrinking
collapse, accelerated diffusion of gases, and negatively charged surface that prevents coalescence into emboli.
Supersaturated oxygen is one such therapy that utilizes microbubbles of oxygen and has seen success in acute
treatments (e.g. myocardial infarctions), but cannot readily be applied for chronic illness such as hypoxia due to
fluid overload. Other alternative treatments in development, such as chemically coated microbubbles or
intravascular respiratory assist catheters, have seen adverse metabolic effects or cardiac intolerance that
prevent their clinical adoption.
The AS-O2-001 system is promising because it utilizes the safety and efficacy of microbubbles in supersaturated
oxygen but removes the overburden of fluids which would be deleterious in severely ill patients with hypoxia.
Furthermore, the AS-O2-001 system is applied in the inferior vena cava and takes lessons learned from
intravascular respiratory assist catheters in order to prevent cardiac intolerance, including a small form factor, a
small insertion size, and the use of biocompatible materials.
In Aim 1, the AS-O2-001 System will be developed and tested in an in vitro model to characterize its safety in
preventing formation of air emboli and its effectiveness in delivering a therapeutic relevant dose. In Aim 2, the
System will be evaluated in vivo to demonstrate the safety and proof of concept of intravenous delivery of oxygen
in a porcine model of normoxemia and hyperoxemia. Successful completion of this project will demonstrate the
feasibility of this novel and innovative method of delivering therapeutic oxygen as intravenously injected
microbubbles.
项目摘要
本第1阶段项目的目标是开发用于静脉内气态氧的AS-O2-001系统
用于治疗缺氧的微泡递送。缺氧是一种灾难性的疾病,可导致急性
呼吸窘迫综合征(ARDS),慢性阻塞性肺病(COPD),肺纤维化,
COVID-19、充血性心力衰竭和心肌梗死。严重受影响患者的现有治疗方案
患者包括体外膜氧合(ECMO)和机械通气,这两者都是
侵入性、昂贵且具有医源性后遗症。Agitated Solutions Inc正在开发一部小说,
有创替代方案:AS-O2-001系统将气态氧微泡输送到下腔静脉,
延迟或阻止机械通气或ECMO。
气态氧输送在历史上曾导致栓塞形成;然而,如今技术的改进
能够输送微泡(<100 µm)。微泡具有独特的性质,包括其收缩性,
塌陷、气体的加速扩散和防止聚结成栓子的带负电荷的表面。
过饱和氧是利用氧气微泡的一种这样的疗法,并且已经在急性呼吸道疾病中取得了成功。
治疗(如心肌梗塞),但不能轻易地应用于慢性疾病,如缺氧,由于
液体超载。正在开发的其他替代治疗方法,如化学涂层微泡或
血管内呼吸辅助导管已经出现了不利的代谢作用或心脏不耐受,
阻止其临床应用。
AS-O2-001系统是有前途的,因为它利用了微泡在过饱和环境中的安全性和有效性。
氧气,但去除了在患有缺氧的重症患者中有害的液体的过量。
此外,AS-O2-001系统应用于下腔静脉,并吸取了
血管内呼吸辅助导管,以防止心脏不耐受,包括小形状因子,
小的插入尺寸和生物相容性材料的使用。
在目标1中,将在体外模型中开发和测试AS-O2-001系统,以表征其在以下情况下的安全性:
防止空气栓塞的形成及其在输送治疗相关剂量方面的有效性。在目标2中,
将在体内对系统进行评价,以证明静脉输注氧气的安全性和概念验证
在正常氧血症和高氧血症的猪模型中。该项目的成功完成将证明
通过静脉注射输送治疗用氧气的新方法的可行性
微泡
项目成果
期刊论文数量(0)
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