Fluid channel Array Brick (FAB) Blood-Gas Exchangers for building Artificial Lungs for Critical Respiratory Failure Treatment
用于构建人工肺以治疗危重呼吸衰竭的流体通道阵列砖 (FAB) 血气交换器
基本信息
- 批准号:10668676
- 负责人:
- 金额:$ 25.96万
- 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:2022-06-01 至 2023-06-30
- 项目状态:已结题
- 来源:
- 关键词:AdultAffectAreaBloodBlood coagulationBlood flowBlood gasCarbon DioxideCoagulation ProcessComplicationCustomDevelopmentDevice DesignsDevicesDiffuseDropsEngineeringEquipmentEvaluationFamilyFiberFrequenciesFundingFutureGasesGoalsGovernmentHealthHealth Care CostsHealth PersonnelHeartHemorrhageHemostatic AgentsHourHypertensionIn VitroLaboratoriesLeadLegal patentLicensingLifeLiquid substanceLungLung TransplantationManufacturer NameMedical DeviceMicrofluidicsModelingMorbidity - disease rateMultiple Organ FailureOperative Surgical ProceduresOutcomeOxygenatorsPatientsPatternPerformancePersonsPhasePorosityProceduresProtocols documentationReadinessRecoveryResearchRespiratory FailureRiskRisk FactorsSafetySelf-Help DevicesSeriesSmall Business Innovation Research GrantStressSurfaceTechnologyTestingTransfusionTreatment FailureVenousWorkartificial lungbaseblood damageblood productcommercial applicationcommercializationcostdesignimprovedin vivo evaluationinfection riskinnovationminiaturized devicemortalitynovelphase 1 studypredictive toolspressureprototypescale upshear stresstime use
项目摘要
Project Summary/Abstract
Essential life-maintaining O2 and CO2 gas exchange for over 1 million patients worldwide with critical
respiratory failure or undergoing heart/lung surgery is provided by flowing blood through an extracorporeal
circuit containing an oxygenator. Commercially available oxygenators use proprietary spaced assemblies of
Hollow Fibers (HFs) as blood-gas exchangers. Blood flows turbulently around the outside of these HFs while a
sweep gas flows through their hollow channels. Through the microporous HF walls, O2 diffuses into the blood,
and CO2 diffuses out, converting venous blood into arterial blood. Key hemostatic complication risk factors of
oxygenators, like blood-contact area, priming volume, turbulent and high-pressure flow conditions,
accumulated shear stress, and gas transfer rate decay pose continuous health risks that affect costs,
treatment, and recovery, and further aggravated by prolonged use, contribute significantly to morbidity and
mortality. HF oxygenator technology has only incrementally improved over the last decade and alternative
technologies that could significantly improve performance and/or safety are still in their low flow capacity stage.
The goal of this SBIR proposal is to develop optimized novel Fluid channel Array Brick (FAB) blood-gas
exchangers, for maximizing safety gains and use time for an optimized family of safer FAB-Oxygenators.
FABs have a patterned array of straight fluid channels with laminar blood flow paths, higher porosity for gas
exchange, and a higher surface-area-to-volume ratio compared to an equivalent HF assembly. Optimized
higher efficiency FABs will lead to significant extracorporeal oxygenator safety gains. This will decrease blood
damage and coagulation risk, unlock longer usage potential, reduce blood product transfusions, and
replacement frequency during long-term use, which further reduces healthcare costs and infection risks. The
long-term goal of the SBIR proposal is to enable the development of a family of safer FAB-Oxygenators, with
each device tailored to the needs of a specific patient class. FAB-Oxygenator scale-up to adult patient class,
together with fully optimized FABs, under a future development, could lead to an extracorporeal artificial lung.
In Phase I, we will design/manufacture a series of FABs with different fluid channel array patterns and test
them inside FAB-Oxygenators for up to 6 hours. These results will be used to develop a performance
prediction for an optimized, full adult FAB-Oxygenators incorporating respective optimized FABs. Feasibility
will be established by in vitro evaluation under the FDA-recommended AAMI 7199 test protocol of optimized
FABs, modeling, and adult FAB-Oxygenator design performance prediction comparison to commercially HF
oxygenators. Phase II funding will allow to develop and test further improved and/or antithrombotic coated
FABs for up to 7 days of use, and to conduct first in vivo testing to refine safety gain advantages. We plan to
establish licensing and FAB-supply partnerships with oxygenator manufacturers and to assemble a team of
experts, clinicians, marketers, manufacturers, and engineers who can jointly bring FAB-Oxygenators to market.
项目总结/摘要
为全球超过100万名危重患者提供维持生命的基本氧气和二氧化碳气体交换
呼吸衰竭或经历心脏/肺手术的患者通过使血液流过体外循环系统来提供
包含氧合器的回路。市售的氧合器使用专有的间隔组件,
中空纤维(HF)作为血气交换器。血液在这些HF的外部恶性流动,
吹扫气体流过它们的中空通道。通过微孔HF壁,O2扩散到血液中,
二氧化碳扩散出来,将静脉血转化为动脉血。关键止血并发症风险因素
氧合器,如血液接触面积、预充体积、湍流和高压流动条件,
累积的剪切应力和气体传输速率衰减造成影响成本的持续健康风险,
治疗和恢复,并进一步加剧了长期使用,大大有助于发病率和
mortality. HF氧合器技术在过去十年中仅逐步改进,
能够显著提高性能和/或安全性的技术仍处于其低流量阶段。
该SBIR提案的目标是开发优化的新型流体通道阵列砖(FAB)血气
交换器,以最大限度地提高安全收益和使用时间,优化更安全的FAB氧合器系列。
FAB具有直线流体通道的图案化阵列,具有层流血液流动路径,气体的孔隙率较高,
交换,和更高的表面积与体积比相比,一个等效的HF组件。优化
更高效率的FAB将导致显著的体外氧合器安全增益。这将减少血液
损伤和凝血风险,释放更长的使用潜力,减少血液制品输血,以及
在长期使用过程中的更换频率,这进一步降低了医疗成本和感染风险。的
SBIR提案的长期目标是开发更安全的FAB氧合器系列,
每种设备都是针对特定患者类别的需求而定制的。FAB-氧合器放大至成人患者类别,
与完全优化的FAB一起,在未来的发展中,可以导致体外人工肺。
在第一阶段,我们将设计/制造一系列具有不同流体通道阵列图案的FAB,并测试
在FAB-氧合器中长达6小时。这些结果将用于开发性能
预测优化的、完整的成人FAB氧合器,其中包含相应的优化FAB。可行性
将根据FDA推荐的AAMI 7199优化试验方案通过体外评价确定
FAB、建模和成人FAB-氧合器设计性能预测与市售HF的比较
氧合器第二阶段的资金将允许开发和测试进一步改善和/或抗血栓涂层
FAB长达7天的使用,并进行首次体内测试,以完善安全性增益优势。我们计划
与氧合器制造商建立许可和FAB供应伙伴关系,并组建一个团队,
专家、临床医生、营销人员、制造商和工程师,他们可以共同将FAB氧合器推向市场。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Karlheinz Strobl其他文献
Karlheinz Strobl的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('Karlheinz Strobl', 18)}}的其他基金
Development of higher efficiency and safer Oxygenators for Critical Respiratory Failure Treatment and Heart/Lung Surgery Assist
开发更高效、更安全的氧合器,用于危重呼吸衰竭治疗和心/肺手术辅助
- 批准号:
10484485 - 财政年份:2022
- 资助金额:
$ 25.96万 - 项目类别:
相似海外基金
How Does Particle Material Properties Insoluble and Partially Soluble Affect Sensory Perception Of Fat based Products
不溶性和部分可溶的颗粒材料特性如何影响脂肪基产品的感官知觉
- 批准号:
BB/Z514391/1 - 财政年份:2024
- 资助金额:
$ 25.96万 - 项目类别:
Training Grant
BRC-BIO: Establishing Astrangia poculata as a study system to understand how multi-partner symbiotic interactions affect pathogen response in cnidarians
BRC-BIO:建立 Astrangia poculata 作为研究系统,以了解多伙伴共生相互作用如何影响刺胞动物的病原体反应
- 批准号:
2312555 - 财政年份:2024
- 资助金额:
$ 25.96万 - 项目类别:
Standard Grant
RII Track-4:NSF: From the Ground Up to the Air Above Coastal Dunes: How Groundwater and Evaporation Affect the Mechanism of Wind Erosion
RII Track-4:NSF:从地面到沿海沙丘上方的空气:地下水和蒸发如何影响风蚀机制
- 批准号:
2327346 - 财政年份:2024
- 资助金额:
$ 25.96万 - 项目类别:
Standard Grant
Graduating in Austerity: Do Welfare Cuts Affect the Career Path of University Students?
紧缩毕业:福利削减会影响大学生的职业道路吗?
- 批准号:
ES/Z502595/1 - 财政年份:2024
- 资助金额:
$ 25.96万 - 项目类别:
Fellowship
感性個人差指標 Affect-X の構築とビスポークAIサービスの基盤確立
建立个人敏感度指数 Affect-X 并为定制人工智能服务奠定基础
- 批准号:
23K24936 - 财政年份:2024
- 资助金额:
$ 25.96万 - 项目类别:
Grant-in-Aid for Scientific Research (B)
Insecure lives and the policy disconnect: How multiple insecurities affect Levelling Up and what joined-up policy can do to help
不安全的生活和政策脱节:多种不安全因素如何影响升级以及联合政策可以提供哪些帮助
- 批准号:
ES/Z000149/1 - 财政年份:2024
- 资助金额:
$ 25.96万 - 项目类别:
Research Grant
How does metal binding affect the function of proteins targeted by a devastating pathogen of cereal crops?
金属结合如何影响谷类作物毁灭性病原体靶向的蛋白质的功能?
- 批准号:
2901648 - 财政年份:2024
- 资助金额:
$ 25.96万 - 项目类别:
Studentship
Investigating how double-negative T cells affect anti-leukemic and GvHD-inducing activities of conventional T cells
研究双阴性 T 细胞如何影响传统 T 细胞的抗白血病和 GvHD 诱导活性
- 批准号:
488039 - 财政年份:2023
- 资助金额:
$ 25.96万 - 项目类别:
Operating Grants
New Tendencies of French Film Theory: Representation, Body, Affect
法国电影理论新动向:再现、身体、情感
- 批准号:
23K00129 - 财政年份:2023
- 资助金额:
$ 25.96万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
The Protruding Void: Mystical Affect in Samuel Beckett's Prose
突出的虚空:塞缪尔·贝克特散文中的神秘影响
- 批准号:
2883985 - 财政年份:2023
- 资助金额:
$ 25.96万 - 项目类别:
Studentship