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）：具有功能性单心室（FSV）解剖结构的先天性心脏病患者通常需要在婴儿期和儿童期进行一系列手术，以便为他们提供生存到成年的机会。第二阶段手术称为半丰坦手术 (HFP)，将全身静脉血从上半身和头部重新引导至肺循环，而不通过中间的心室。由于血液流入肺部很大程度上是一个被动过程，因此肺血管系统内的任何解剖学阻塞、肺血管阻力升高或明显的心室功能障碍都可能导致患者半侧 Fontan 压力升高。在分阶段姑息治疗过程的早期，半 Fontan 通路内出现的问题可能会导致 Fontan 手术期间以及 Fontan 患者一生中发生并发症的风险增加。因此，维持最佳的半 Fontan 解剖学和生理学对于 FSV 患者的长期成功和生存非常重要。目前，在术后立即或在等待 Fontan 期间的动态环境中常规测量半 Fontan 通路压力并不是大多数机构的标准做法。术后监测半侧 Fontan 压力需要在上身或颈部静脉留置导管。这有可能导致全身静脉完全血栓形成，这对于半侧 Fontan 患者来说是一种毁灭性的并发症。此外，连续门诊心导管插入术测量半方丰坦压力会使婴儿面临手术并发症的风险。因此，为了向 ICU 和门诊环境的临床医生提供测量半 Fontan 压力的方法，研究人员正在开发一种小型压力传感器，可以在第二阶段手术时直接植入半 Fontan 通路。所提出的植入式压力监测仪将在术后立即提供半 Fontan 通路的现成血流动力学评估，而没有全身静脉血栓形成的风险。在门诊环境中对半丰唐通路压力进行间隔测试将使临床医生能够观察压力上升的趋势，这可能会提供正在发生的问题的早期指示，并允许在发生不可逆转的损害之前进行早期干预。这将在没有心导管插入术相关风险的情况下完成。在这项研究期间，研究人员将完成微型植入式无线压力传感器的开发。将实现最终设计冻结，并完成设计控制要求，包括风险分析、生物相容性测试、无菌和制造工艺，以满足 FDA 的要求。将进行临床前动物研究，包括长期 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，这项研究将支持研究人员在申请过程中获得 FDA 的研究设备豁免，以对患有这些复杂形式的先天性心脏病的婴儿进行初步可行性研究。