Steerable MEMS Instruments for Precise Intracardiac Surgery

描述(申请人提供)：在许多影响胎儿、儿科和成人患者的情况下，现有的修复心脏内部结构的工具和技术导致了不太理想的介入时机和方法。虽然基于导管的技术改变了某些疾病的治疗方法，但毫米和亚毫米级传统制造方法的崩溃严重限制了导管输送仪器的复杂性，从而限制了它们的实用性。相比之下，开放的外科手术允许复杂的重建和患者定制的修复，然而，它们涉及大量的创伤和风险。所需要的是一种器械技术，它结合了微创手术的有限的附带组织损伤和开放手术方法的灵活性和定制适合性。我们建议通过将工具和植入物安装在高精度可定向针尖上来开发这种技术，这些工具和植入物使用3D微电子机械系统(MEMS)技术构建。这些针由弯曲的超弹性管的同心组合建造而成，它们将能够蜿蜒穿过心腔到达手术部位。与传统的MEMS器件不同，我们将使用的EFAB MEMS工艺将使我们能够用金属构建完全组装的复杂毫米级机械装置，这些金属可以从其基板上移除以用于针安装。为工具提供动力的控制线可以穿过针腔，类似于现有的手持和机器人微创仪器。三维MEMS技术有可能给微创工具和植入物的设计带来革命性的变化。3DMEMS设备的多功能性可能会使新的微创程序成为可能，并提高当前程序的精度。利用端口接入，可定向的针将提供一个高度精确的平台，将工具定位在心脏内，并将足够坚硬，以施加操纵组织所需的力。这个问题的复杂性非常适合于BRP。PI组建了一个多学科团队，并在行业工程师(MicroFaba)、临床研究人员(波士顿儿童医院)和大学工程师(波士顿大学)之间建立了独特的合作伙伴关系。我们将共同开发这项技术，以满足以下具体目标：目标1-开发用于儿童/成人心内组织摘除的可定向MEMS器械。目的2-研制用于儿童/成人心内组织逼近的可控式MEMS器械。目的3-研制一种可操控的MEMS胎儿心内组织摘除器。

DESCRIPTION (provided by applicant): In many situations affecting fetal, pediatric and adult patients, existing tools and techniques for repairing structures inside the heart result in suboptimal interventional timing and approach. While catheter-based techniques have transformed the treatment of certain conditions, the breakdown of traditional manufacturing methods at the millimeter and sub-millimeter scale has placed severe limitations on the complexity of catheter-delivered instruments and consequently on their utility. In contrast, open surgical procedures permit complex reconstruction and patient-tailored repairs, however, they involve substantial trauma and risk. What is needed is an instrument technology which combines the limited collateral tissue damage of a minimally invasive procedure with the dexterity and custom fit afforded by the open surgical approach. We propose to develop such a technology by mounting tools and implants constructed using 3D microelectromechanical systems (MEMS) technology on the tips of high-precision steerable needles. Constructed from the concentric combination of curved superelastic tubes, these needles will be able to snake their way through the heart's chambers to a surgical site. And unlike traditional MEMS devices, the EFAB MEMS process we will use will allow us to construct fully-assembled complex millimeter-scale mechanisms from metals which can be removed from their substrate for needle mounting. Control wires to power the tools can be run through the needle's lumen similar to existing handheld and robotic minimally invasive instruments. Three-dimensional MEMS technology has the potential to revolutionize the design of minimally invasive tools and implants. The versatility of 3D MEMS devices is likely to enable new minimally invasive procedures and to improve the precision of current procedures. Using port access, the steerable needles will provide a highly precise platform for positioning the tools within the heart and will be stiff enough to apply the forces necessary to manipulate the tissue. The complexity of this problem is well suited to a BRP. The PI has assembled a multidisciplinary team and established a unique partnership among industry-based engineers (Microfabrica), clinical investigators (Children's Hospital, Boston) and university-based engineers (Boston University). Together, we will develop this technology by addressing the following specific aims: Aim 1 - Develop Steerable MEMS Instruments for Pediatric / Adult Intracardiac Tissue Removal. Aim 2 - Develop Steerable MEMS Instruments for Pediatric / Adult Intracardiac Tissue Approximation. Aim 3 - Develop a Steerable MEMS Instrument for Fetal Intracardiac Tissue Removal.