Non Magnetic MRI Conditional External Defibrillator with Reduced Skeletal Muscle Contraction

减少骨骼肌收缩的非磁 MRI 条件性体外除颤器

• 批准号: 10698845
• 负责人: ALBERT Clark LARDO
• 金额: $ 25.93万
• 依托单位: CORAM TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-11 至 2024-09-10
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10698845
• 关键词: Abdomen; Ablation; Acceleration; Adverse event; American; Anesthesia procedures; Anesthetics; Arrhythmia; Award; Biopsy; Childhood; Claustrophobias; Clinical; Congresses; Defibrillators; Development; Diagnosis; Diagnostic; Electric Countershock; Electrocardiogram; Environment; Equipment; Event; Excision; External Defibrillator; Family suidae; Frequencies; Head; Heart Arrest; Intervention; Learning Disorders; Legal patent; Licensing; Life; Location; MRI Scans; Magnetic Resonance Imaging; Manuals; Marketing; Mediation; Medical emergency; Methods; Modernization; Morphologic artifacts; Motion; Movement Disorders; Muscle; Muscle Contraction; Operative Surgical Procedures; Outcome; Pain; Patient Monitoring; Patients; Pediatrics; Pelvis; Phase; Positioning Attribute; Procedures; Property; Radiation; Radiology Specialty; Ramp; Resuscitation; Risk; Safety; Scanning; Secure; Sedation procedure; Shock; Skeletal Muscle; Specific qualifier value; System; Technology; Testing; Thermal Ablation Therapy; Uncertainty; United States; Universities; Ventricular Fibrillation; Ventricular Tachycardia; Vertebral column; anesthesia complication; commercialization; conditioning; congenital heart disorder; experience; high risk; magnetic field; mortality; nervous system disorder; phase 1 study; prevent; programs; prototype; safety testing; tumor; ventilation

There are over 36 million MRI scans done each year in the United States, and anesthesia or sedation is used in a significant number of those scans. This is especially true in pediatrics where as many as 28% of MRI scans are done with anesthesia, and the increased use of anesthesia has increased the utilization of MRI. It has long been known that cardiac arrest from ventricular fibrillation can complicate anesthesia administration. Even with modern methods, cardiac arrest still can occur during anesthesia management, with mortality as high as 30%. In addition, cardiac arrest can occur during MRI scans even without anesthesia. There are also MRI-guided interventions that are not currently being performed, such as ablation of ventricular tachycardia, because of the high risk of ventricular fibrillation, and the lack of the availability of immediate defibrillation. Delays in defibrillation occur due to the need for removal of the patient from the scanner, placement onto a stretcher, and relocation to a nearby environment stocked with resuscitation equipment. The defibrillator cannot be near the scanner since the magnet can draw a defibrillator into the bore of the scanner. Defibrillation can be further delayed by uncertainty in diagnosing lethal arrhythmias due to MRI-induced ECG artifacts. Each minute in delay to defibrillation can reduce survival by 5-10%. The unmet clinical need, therefore, is the lack of availability of a system that would allow defibrillation in the scanner room, and ideally in the bore of the scanner itself, thereby minimizing delays in defibrillation. The central hypothesis is that we can develop a defibrillator that would allow defibrillation in the MRI scanner, reducing delays, and also allowing procedures with a higher risk of arrhythmias to be done under MRI guidance. Defibrillation can be done in the scanner because of the MRI compatible properties of the system, and because motion of the patient caused by the shock is substantially reduced by a pre-shock waveform that reduces skeletal muscle contraction, preventing the patient from “jumping” into the scanner bore walls. The overall objective of this proposal is to construct such a defibrillator system, and test the system in swine studies. Coram Technologies has the expertise to accomplish this objective. The preliminary studies that have been done show the feasibility of the critical subsystems. In addition, there likely will be strong patent protection for this technology. The Specific Aims are: Aim 1: To develop a functional prototype of an MRI conditional external defibrillator incorporating the pre-shock muscle conditioning waveform. Aim 2: To test the functionality of the prototype in swine in and out of the MRI scanner. The expected outcomes from this program include the development of a functional prototype that can defibrillate swine both outside and inside the MRI scanner, and is safe to use in the MRI environment at 1.5 and 3T. An exclusive license for a patent covering the technology is also expected to be secured. A commercial version of the prototype will be developed and validated in Phase II. If this project is successful, this defibrillator will likely become a “must have” for any MRI scanner where patient monitoring equipment is used, which is approximately 50% of the total number of MRI scanners.

美国每年进行超过 3600 万次 MRI 扫描，并且需要麻醉或镇静 在大量扫描中使用。这在儿科尤其如此，其中多达 28% 的 MRI 扫描是在麻醉下完成的，麻醉使用的增加也增加了 MRI 的利用率。它有 人们早就知道心室颤动导致的心脏骤停会使麻醉管理变得复杂。甚至 采用现代方法，麻醉期间仍可能发生心脏骤停，死亡率高达 30%。此外，即使没有麻醉，MRI 扫描期间也可能发生心脏骤停。还有MRI引导的 目前尚未实施的干预措施，例如室性心动过速消融，因为 心室颤动的高风险，并且缺乏立即除颤的可能性。除颤延迟 发生的原因是需要将患者从扫描仪中移出、放置到担架上以及转移到 附近配备有复苏设备的环境。除颤器不能靠近扫描仪，因为 磁铁可以将除颤器吸进扫描仪的孔中。除颤可以进一步延迟 由于 MRI 引起的心电图伪影，诊断致死性心律失常存在不确定性。每延迟一分钟 除颤可使生存率降低 5-10%。因此，未满足的临床需求是缺乏可用的 允许在扫描仪室除颤的系统，最好是在扫描仪本身的孔内除颤，从而 最大限度地减少除颤延迟。中心假设是我们可以开发一种除颤器，它可以让 MRI 扫描仪中的除颤，减少延误，并允许心律失常风险较高的手术 需在 MRI 引导下进行。由于兼容 MRI，除颤可以在扫描仪中完成 系统的特性，并且因为由冲击引起的患者运动被显着减少 预电击波形可减少骨骼肌收缩，防止患者“跳入” 扫描仪钻孔墙壁。该提案的总体目标是构建这样一个除颤器系统，并测试 猪研究系统。 Coram Technologies 拥有实现这一目标的专业知识。初步的 已完成的研究表明了关键子系统的可行性。此外，很可能还会有强 该技术的专利保护。具体目标是： 目标 1：开发 MRI 的功能原型 条件性体外除颤器包含预电击肌肉调节波形。目标 2：测试 猪进出 MRI 扫描仪时原型的功能。该计划的预期成果 包括开发一种功能原型，可以在 MRI 外部和内部对猪进行除颤 扫描仪，可在 1.5 和 3T 的 MRI 环境中安全使用。专利的独家许可涵盖 预计技术也将得到保障。将开发并验证原型的商业版本 在第二阶段。如果这个项目成功，这款除颤器可能会成为任何 MRI 扫描仪的“必备品” 使用患者监护设备的地方约占 MRI 扫描仪总数的 50%。