SBIR Phase I: Development of a textile-based retrievable stent for stroke that can be personalized to a patient's clot burden and retrieve long clots using torsion.

SBIR 第一阶段：开发一种用于中风的基于织物的可回收支架，可以根据患者的血栓负荷进行个性化设计，并通过扭转来回收长血栓。

• 批准号: 1819491
• 负责人: Vallabh Janardhan
• 金额: $ 22.17万
• 依托单位: Insera Therapeutics Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-01 至 2018-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1819491&HistoricalAwards=false
• 关键词: SBIR; Phase; Development; textile; based

The broader impact/commercial potential of this Small Business Innovation Research(SBIR) project is significant as it offers a disruptive new mechanical approach to stroketreatment. Each year, 795,000 strokes occur in the U.S., 1.7 million strokes in Europe, andnearly 20.5 million strokes worldwide. This public-private partnership is expected to have animportant positive societal impact on the community by saving lives especially the elderly anddecreasing the economic burden of stroke on the taxpayer. This life-saving device has a uniquevalue proposition for health-systems with lower inventory costs from a single size device, andfor patients with better vessel re-opening rates, thereby saving brain cells. This textile-basedbraided retrievable stent, also known as an embolus retriever or thrombectomy-assist device isan innovation that will enhance scientific and technological understanding of how personalizedmedicine can transform the care of stroke patients in the U.S. and worldwide.This SBIR Phase I project proposes to bring to market the industry?s longest blood clotor embolus retriever for removal of short and long clots that can be customized by the operatorbased on each patient?s clot burden. In addition, it is the first textile-based braided retrievablestent which works well in conjunction with standard catheter-based aspiration systems for stroketreatment developed in the U.S. that can be personalized to all clot lengths. Stroke is a majorproblem causing 5.5 million deaths worldwide and currently there is no cost-effective andefficacious treatments. The mean lifetime healthcare cost per stroke patient is $140,048. Thistextile-based clot retrieval device (aka thrombectomy-assist device) is a cost-effective medicaldevice that can help save a stroke patient?s life. The methods and approaches of this project isto compare via pre-clinical tests the ability of a textile-based medical device to re-open vesselsblocked with clots compared with existing approved treatments. The goals and scope of theresearch will focus on the ability to rapidly re-open vessels that are blocked by clots. This pavesthe way for personalized medicine with a customizable stroke treatment device that can betailored to a patient?s clot burden.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这个小企业创新研究（SBIR）项目的更广泛的影响/商业潜力是重要的，因为它提供了一种破坏性的新的机械方法来治疗中风。美国每年有79.5万人中风，1.7在欧洲有100万人中风，在全世界有2050万人中风。这种公私伙伴关系有望通过挽救生命，特别是老年人的生命和减少纳税人中风的经济负担，对社区产生重要的积极社会影响。这一救生设备对于医疗系统具有很高的价值，因为单一尺寸的设备具有更低的库存成本，并且对于患者具有更好的血管重新开放率，从而节省脑细胞。这种基于纺织品的编织可回收支架，也称为栓子回收器或血栓切除辅助装置，是一项创新，将增强对个性化医疗如何改变美国和全球中风患者护理的科学和技术理解。SBIR第一阶段项目提议将该行业推向市场？最长的血栓取栓器，用于清除短凝块和长凝块，可由术者根据每位患者定制？s凝块负担。此外，它是第一个基于纺织品的编织可回收支架，与美国开发的用于中风治疗的标准导管抽吸系统配合使用效果良好，可以根据所有凝块长度进行个性化设置。中风是一个主要的问题，在全球造成550万人死亡，目前还没有成本效益和有效的治疗方法。每位中风患者的平均终身医疗费用为140，048美元。这种基于纺织品的凝块取出装置（又称血栓切除辅助装置）是一种具有成本效益的医疗装置，可以帮助挽救中风患者？的生活。本项目的方法和途径是通过临床前试验比较基于纺织品的医疗器械与现有获批治疗方法重新打开血栓阻塞血管的能力。研究的目标和范围将集中在快速重新打开被血栓阻塞的血管的能力上。这为个性化医疗铺平了道路，可定制的中风治疗设备，可以为患者量身定制？该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

项目成果

Optimizing Radial Force Of Braided Thrombectomy-assist Devices Compared To Laser-cut Stent Retrievers In The MCA.

与 MCA 中的激光切割支架回收器相比，优化编织血栓切除辅助装置的径向力。

• 发表时间: 2018
• 期刊: Society of Vascular & Interventional Neurology (SVIN
• 作者: Katz, Jeffrey M;Chebl, Alex A;Janardhan, Vikram;Janardhan, Vallabh.
• 通讯作者: Janardhan, Vallabh.

Customizable Uniform and Cyclical Aspiration Thrombectomy Using a Digital Smart Pump: An In-Vitro Feasibility Study.

使用数字智能泵进行可定制的均匀和周期性抽吸血栓切除术：体外可行性研究。

• 发表时间: 2018
• 期刊: Society of Vascular & Interventional Neurology (SVIN
• 作者: Jagadeesan, Bharathi D;Chebl, Alex A;Janardhan, Vikram;Janardhan, Vallabh
• 通讯作者: Janardhan, Vallabh

Radial Force of Braided Thrombectomy-Assist Devices Vis-à-Vis Laser-cut Stent Retrievers in the ICA and Basilar.

ICA 和基底动脉中编织血栓切除辅助装置 Vis-à-Vis 激光切割支架回收器的径向力。

• 发表时间: 2018
• 期刊: Society of Vascular & Interventional Neurology (SVIN
• 作者: Chebl, Alex A;Katz, Jeffrey M;Janardhan, Vikram;Janardhan, Vallabh.
• 通讯作者: Janardhan, Vallabh.

Complete clot ingestion with cyclical ADAPT increases first-pass recanalization and reduces distal embolization

• DOI: 10.1136/neurintsurg-2018-014625
• 发表时间: 2019-09-01
• 期刊: JOURNAL OF NEUROINTERVENTIONAL SURGERY
• 影响因子: 4.8
• 作者: Arslanian, Rose A.;Marosfoi, Miklos;Chueh, Ju-Yu
• 通讯作者: Chueh, Ju-Yu

E-106 Feasibility of automation of staged balloon guide catheter (BGC) aspiration during stroke thrombectomy using a customizable Ipad app and a bluetooth-enabled smart pump: an in-vitro study

E-106 — 使用可定制的 iPad 应用程序和支持蓝牙的智能泵，在中风血栓切除术期间自动进行分阶段球囊引导导管 (BGC) 抽吸的可行性：一项体外研究

• DOI: 10.1136/neurintsurg-2018-snis.182
• 发表时间: 2018
• 期刊: Journal of neurointerventional surgery
• 影响因子: 4.8
• 作者: Jagadeesan, Bharathi D;Janardhan, Vikram;Janardhan, Vallabh.
• 通讯作者: Janardhan, Vallabh.