An Organ Perfusion Stent as an Alternative to Surgery in Donor Organ Recovery

器官灌注支架作为供体器官恢复手术的替代方案

• 批准号: 9770857
• 负责人: Young Jae Chun
• 金额: $ 34.4万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2020-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9770857
• 关键词: 3-Dimensional; 3D Print; Abdomen; Address; Anatomy; Angiography; Arteries; Biopsy; Blood; Blood Circulation; Blood Pressure; Blood Vessels; Blood flow; Cadaver; Cardiac; Cardiac Death; Cardiopulmonary; Catheters; Clinical; Consent; Control Animal; Critical Illness; Custom; Devices; Dialysis procedure; Engineering; Ensure; Ethics; Evaluation; Excision; Family; Family suidae; Fluoroscopy; Gold; Healthcare Systems; Heart; Histologic; Human; Hybrids; Imaging Device; In Vitro; Injury; Intervention; Intubation; Investigation; Laboratories; Life; Liquid substance; Liver; Logistics; Mechanics; Modeling; Monitor; Needlestick Injuries; Operative Surgical Procedures; Organ; Organ Donor; Organ Model; Organ Transplantation; Outcome; Pancreas; Patients; Pattern; Performance; Perfusion; Physiology; Pilot Projects; Polytetrafluoroethylene; Positioning Attribute; Postoperative Period; Prevention; Property; Recovery; Reperfusion Injury; Reporting; Research; Retrieval; Roentgen Rays; Solid; Source; Stents; Structure; Techniques; Time; Transplantation; Transplantation Surgery; United States; Vascular Endothelium; Visceral; base; blood perfusion; cost; design; design and construction; end of life care; heart function; hemodynamics; improved; in vivo; innovation; kidney biopsy; mechanical properties; miniaturize; novel; organ ethics; portability; prevent; prototype; radio frequency; scaffold

PROJECT SUMMARY In the United States, there is a critical shortage of organs for transplant, with only a quarter of the 120,000 patients in need of an organ actually receiving one. The cost of patients awaiting transplant to the healthcare system totals tens of billions of dollars each year. Meanwhile, thousands of organs are discarded each year as a result of injury from inadequate blood flow (ischemic injury) as the donor is dying. The traditional paradigm for consented Donation after Cardiac Death donors has been to discontinue cardiopulmonary life support, leaving organs without adequate blood perfusion until the heart stops. This contrasts with the usual end of life care options for patients who are not donors, in which patients and their families can elect to withhold life support for some body functions (CPR, agents to maintain blood pressure, dialysis, or intubation) while at the same time maintaining life support for other organs. Our proposal details an innovative needlestick approach to maintain selective blood flow to the organs while allowing the donor heart to fail on its own terms. This contrasts to previously reported approaches which would accelerate cardiac death, against ethical principles. We have examined a commercial hybrid prototype Organ Perfusion Stent (OPS) in a pilot study and shown improved blood delivery to organs without a negative impact on cardiac function. Recognizing the logistical challenges of current imaging for device placement in a critically ill patient, such as a donor, we have also developed a portable radiofrequency (RF) approach for stent positioning at bedside. The primary objective of the current approach is to demonstrate that a novel custom made OPS provides objective protection against ischemic organ injury. Our investigation will begin with optimizing the mechanical properties of this novel dual-chambered stent to ensure rapid deployment, successful isolation of the visceral arteries, and simplified retrieval. Next, we will optimize the hemodynamics of the stent to ensure uniform blood flow to the organs. A miniaturized RF antenna will then be directly printed onto the stent structure. In a porcine model of the organ donor, an OPS will be deployed by a needlestick access while under close cardiac monitoring. Positioning approaches using both portable X-ray and RF tag approaches will be compared to gold standard angiography for device positioning. Following a 60 minute period of simulated malperfusion with interval biopsies, both stented and control animals will be recovered with daily assessment to monitor organ function. At two days postoperatively, liver, pancreas and kidney biopsies will be evaluated for ischemic changes histologically. To investigate this device in a human context, an OPS calibrated for human anatomy will then be evaluated for successful deployment and organ perfusion in a heart beating human cadaver model. In summary, we expect that ultimately, an Organ Perfusion Stent may allow every consented donor to successfully donate organs for transplant while respecting the ethics of organ recovery.

项目摘要 在美国，移植器官的严重短缺，只有四分之一 需要一个器官的120,000名患者实际上接受了一个。等待移植到的患者的费用 医疗系统每年总计数百亿美元。同时，丢弃了成千上万的器官 每年由于供体死亡而导致血流不足（缺血性损伤）受伤。这 心脏死亡捐助者已经停止的传统范式用于同意捐赠 心肺生命的支持，使器官无足够的血液灌注，直到心脏停止。这 与非捐助者的患者通常的生命护理选择相反，患者及其患者 家庭可以选择保留某些身体功能的生命支持（CPR，维持血压的代理， 透析或插管）同时维持对其他器官的生命支持。我们的建议详细介绍了 创新的针刺方法，以保持有机器官的选择性血流，同时允许供体心脏 按照自己的条款失败。这与先前报道的方法会加速心脏死亡的方法形成鲜明对比， 反对道德原则。我们检查了商业混合原型器官灌注支架（OP） 一项试点研究，并显示出对器官的血液递送改善，对心脏功能没有负面影响。 认识到当前成像在重症患者中设备放置的后勤挑战，例如 捐助者，我们还开发了一种便携式射频（RF）方法，用于在床边定位支架。 当前方法的主要目的是证明一种新颖的自定义行动 提供对缺血器官损伤的客观保护。我们的调查将从优化 这种新型双座支架的机械性能，以确保快速部署，成功隔离 内脏动脉和简化检索。接下来，我们将优化支架的血液动力学，以确保 均匀的血液流向器官。然后将微型的RF天线直接印刷到支架上 结构。在器官捐赠者的猪模型中，针刺访问将部署OPS 在密切的心脏监测下。使用便携式X射线和RF标签方法的定位方法将 与用于设备定位的金标准血管造影相比。经过60分钟的模拟 通过间隔活检的疏松率，将在日常评估中回收支架和对照动物 监视器官功能。术后两天，将评估肝脏，胰腺和肾脏活检 对于缺血性变化在组织学上。为了在人类的情况下调查该设备，对OPS进行了校准 然后，将评估人体解剖结构，以在心脏跳动中成功部署和器官灌注 人尸体模型。总而言之，我们希望最终，器官灌注支架可能允许每个 同意捐助者成功地捐赠了器官进行移植，同时尊重器官恢复的道德规范。