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.

在美国，每年进行超过3600万次MRI扫描，麻醉或镇静是 在其中大量扫描中使用。这在儿科尤其如此，其中多达28%的MRI 扫描是在麻醉下进行的，麻醉的使用增加了MRI的使用。它有 长期以来已知心室纤维性颤动引起的心脏骤停会使麻醉给药复杂化。甚至 使用现代方法，在麻醉管理期间仍然可能发生心脏骤停，死亡率高达 百分之三十此外，即使没有麻醉，MRI扫描也可能发生心脏骤停。也有MRI引导的 目前未进行的介入治疗，例如室性心动过速消融术， 心室颤动的高风险，以及缺乏立即除颤的可用性。除颤延迟 由于需要将患者从扫描仪中取出，放置在担架上，并重新安置到 附近有复苏设备的地方除颤器不能靠近扫描仪，因为 磁体可以将除颤器吸引到扫描器的孔中。除颤可以进一步延迟， MRI诱导的ECG伪影导致的致命性心律失常诊断的不确定性。每延迟一分钟， 除颤会使存活率降低5- 10%。因此，未满足的临床需求是缺乏可用的 该系统将允许在扫描室中除颤，并且理想地在扫描仪本身的孔中除颤，从而 最小化除颤延迟。核心假设是我们可以开发出一种除颤器， 在MRI扫描仪中进行除颤，减少延迟，并允许心律失常风险较高的手术 在MRI引导下完成。除颤可以在扫描仪中完成，因为MRI兼容 系统的特性，并且因为由电击引起的患者的运动被显著地减少， 电击前波形可减少骨骼肌收缩，防止患者“跳”入 扫描器钻墙本提案的总体目标是构建这样的除颤器系统，并测试 猪的研究。Coram Technologies拥有实现这一目标的专业知识。初步 已经进行的研究表明，关键子系统是可行的。此外，可能会有强大的 这项技术的专利保护。具体目标是：目标1：开发MRI的功能原型 结合电击前肌肉调节波形的条件性体外除颤器。目标2：测试 原型在猪进出MRI扫描仪中的功能。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扫描， 扫描仪，并在1.5和3 T的MRI环境中安全使用。一项专利的独占许可， 技术也有望得到保障。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，这款除颤器将有可能成为任何核磁共振扫描仪的“必备品” 其中使用患者监测设备，约占MRI扫描仪总数的50%。