Novel Micro-Implant to Measure Intracardiac Pressure in Congenital Heart Patients

用于测量先天性心脏病患者心内压的新型微型植入物

• 批准号: 8538493
• 负责人: Martin Bocks
• 金额: $ 60.93万
• 依托单位: INTEGRATED SENSING SYSTEMS, INC. (ISSYS)
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8538493
• 关键词: Acute; Adult; Adverse effects; Anatomy; Animals; Attention; Biocompatible; Birth; Blood; Blood flow; Cardiac; Cardiac Catheterization Procedures; Caring; Child; Childhood; Chronic; Clinical Trials; Clinical trial protocol document; Coagulation Process; Common Ventricle; Communication; Complex; Complication; Congenital Abnormality; Contracts; Data; Development; Device Safety; Devices; Early Intervention; Electronics; Ensure; Excision; Feasibility Studies; Financial compensation; Fontan Procedure; Freezing; Funding; Goals; Guidelines; Head; Healthcare; Heart; Hematology; Hemi-Fontan Procedure; High temperature of physical object; Human; Implant; Indwelling Catheter; Infant; Institution; Laboratories; Lead; Life; Lung; Measurement; Measures; Mechanics; Medical; Michigan; Monitor; Morbidity - disease rate; Neck; Obstruction; Operative Surgical Procedures; Orphan; Outpatients; Pathway interactions; Patients; Performance; Pharmaceutical Preparations; Phase; Physicians; Physiology; Postoperative Period; Preparation; Process; Protocols documentation; Pulmonary Circulation; Pulmonary Thromboembolism; Pulmonary Vascular Resistance; Pulmonary artery structure; Pump; Pyrogens; Recommendation; Reporting; Research Personnel; Resources; Risk; Risk Assessment; Route; Safety; Series; Shapes; Staging; Sterilization; System; Systemic venous structure; Temperature; Testing; Thrombosis; Thrombus; Time; Tissues; Universities; Veins; Venous; Venous Thrombosis; Ventricular; Ventricular Dysfunction; Wireless Technology; animal facility; animal tissue; base; biomaterial compatibility; congenital heart disorder; design; hemodynamics; high risk; implantable device; improved; in vivo; infancy; intracardiac pressure; manufacturing process; meetings; miniaturize; mortality; novel; operation; palliation; patient population; pre-clinical; pressure; product development; prototype; response; sensor; sterility testing; success; trend

DESCRIPTION (provided by applicant): Congenital heart disease patients with functional single ventricle (FSV) anatomy usually require a series of surgeries during infancy and childhood in order to provide them with a chance to survive into adulthood. The second stage surgery, termed the hemi-Fontan procedure (HFP) re-routes systemic venous blood from the upper body and head into the pulmonary circulation without passing through an intervening ventricular chamber. Because blood flow into the lungs is largely a passive process, any anatomic obstruction within the pulmonary vasculature, elevated pulmonary vascular resistance, or significant ventricular dysfunction can result in patients having elevated hemi-Fontan pressures. Problems that develop within the hemi-Fontan pathway early in the staged palliation process can result in an increased risk for complications during the Fontan operation and throughout a Fontan patient's life. Therefore, maintaining optimal hemi-Fontan anatomy and physiology is important for long term success and survival for FSV patients. Currently, it is not standard practice at most institutions to routinely measure hemi-Fontan pathway pressures in the immediate post- operative period or in the ambulatory setting while awaiting the Fontan. Post-operative monitoring of the hemi- Fontan pressures requires an indwelling catheter in an upper body or neck vein. This has the potential to lead to complete thrombosis of the systemic vein, which is a devastating complication for the hemi-Fontan patient. Furthermore, serial outpatient cardiac catheterizations to measure hemi-Fontan pressures place infants at risk for procedural complications. Therefore, to provide clinicians in the ICU and in the ambulatory setting with the means to measure hemi-Fontan pressures, investigators are developing a miniaturized pressure sensor that can be implanted directly into the hemi-Fontan pathway at the time of the second stage operation. The proposed implantable pressure monitor will provide readily available hemodynamic assessment of the hemi- Fontan pathway during the immediate post-operative period without the risk of systemic venous thrombosis. Interval testing of the hemi-Fontan pathway pressure in the ambulatory setting will allow clinicians to observe for rising pressure trends, which may provide early indication of a problem that is developing and allow for earlier intervention before irreversible damage has occurred. This will be accomplished without the risk associated with cardiac catheterization. During this study investigators will complete the development of a miniature implantable wireless pressure sensor. Final design freeze will be achieved, and design control requirements, including risk analysis, biocompatibility testing, sterility, and manufacturing processes, will be completed to satisfy FDA requirements. Preclinical animal studies will be carried out, including a chronic GLP animal study, to determine the device's in vivo biocompatibility, functionality, and safety profile. Finally, this study will support investigators during the application process to obtain Investigational Device Exemption from the FDA for the initial feasibility studies in infants with these complex forms of congenital heart disease.

描述（由申请人提供）：具有功能性单脑室（FSV）解剖结构的先天性心脏病患者通常需要在婴儿期和童年期间进行一系列手术，以便为他们提供生存到成年的机会。第二阶段的手术​​称为半联邦手术（HFP），从上半身重新释放了全身性静脉血，并前往肺部循环，而无需穿过中间的心室腔室。由于流入肺部的血液在很大程度上是一种被动过程，因此肺血管内的任何解剖阻塞，肺血管耐药性升高或明显的心室功能障碍都会导致患者的半联邦抗压升高。在上演的抚慰过程中，在半联邦大通路中出现的问题会导致方坦操作期间以及整个方坦患者的寿命增加并发症的风险。因此，维持最佳的半联邦解剖结构和生理学对于FSV患者的长期成功和存活至关重要。目前，在大多数机构中，在等待丰坦的同时，通常在手术后或门诊环境中常规衡量半联邦通路压力并不是标准做法。对半叉压力的术后监测需要在上半身或颈部静脉中留置导管。这有可能导致全身性静脉的完全血栓形成，这对半联邦省患者来说是毁灭性的并发症。此外，串行的门诊心脏导管测量半联邦的压力使婴儿处于程序并发症的风险。因此，为了在ICU和门诊环境中为临床医生提供测量半联邦压力的手段，研究人员正在开发一个微型压力传感器，该压力传感器可以在第二阶段操作时直接植入半联邦的途径。拟议的可植入压力监测仪将在术后立即提供容易获得的血液动力学评估，而不会出现全身性静脉血栓形成的风险。在门诊环境中半联邦通路压力的间隔测试将使临床医生能够观察到压力趋势的上升，这可能会提供正在出现的问题的早期指示，并在发生不可逆损害之前允许较早的干预。这将在没有与心脏导管插入术相关的风险的情况下完成。在这项研究中，研究人员将完成微型植入无线压力传感器的开发。最终的设计将冻结，并将完成设计控制要求，包括风险分析，生物相容性测试，不育和制造过程，以满足FDA要求。将进行临床前动物研究，包括一项慢性GLP动物研究，以确定该设备的体内生物相容性，功能和安全性。最后，这项研究将在申请过程中支持研究人员，以获得FDA的研究设备豁免，以对具有这些复杂形式的先天性心脏病的婴儿进行最初的可行性研究。