Steerable MEMS Instruments for Precise Intracardiac Surgery

描述（由申请人提供）：在影响胎儿、儿童和成人患者的许多情况下，现有的修复心脏内部结构的工具和技术导致介入时机和方法不理想。虽然基于导管的技术已经改变了某些疾病的治疗，但传统制造方法在毫米和亚毫米尺度上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，开放式外科手术允许复杂的重建和患者定制的修复，然而，它们涉及巨大的创伤和风险。我们所需要的是一种仪器技术，它能将微创手术中有限的侧支组织损伤与开放手术方法所提供的灵活性和定制性相结合。我们建议通过在高精度导向针的尖端安装使用3D微机电系统（MEMS）技术构建的工具和植入物来开发这种技术。由弯曲的超弹性管组成的同心组合，这些针将能够穿过心脏腔室到达手术部位。与传统的MEMS器件不同，我们将使用的EFAB MEMS工艺将允许我们从金属中构建完全组装的复杂毫米级机构，这些机构可以从基板上移除以进行针安装。与现有的手持式和机器人微创仪器类似，驱动工具的控制线可以穿过针腔。三维MEMS技术有可能彻底改变微创工具和植入物的设计。3D MEMS器件的多功能性可能会使新的微创手术成为可能，并提高当前手术的精度。使用端口通道，可操纵的针头将提供一个高度精确的平台，用于在心脏内定位工具，并且足够坚硬，可以施加必要的力量来操纵组织。这个问题的复杂性非常适合BRP。PI已经组建了一个多学科团队，并在基于工业的工程师（Microfabrica）、临床研究人员（波士顿儿童医院）和基于大学的工程师（波士顿大学）之间建立了独特的伙伴关系。我们将共同开发这项技术，以解决以下具体目标：目标1 -开发用于儿科/成人心内组织切除的可控MEMS仪器。目标2 -开发用于儿科/成人心内组织近似的可操纵MEMS仪器。目的3 -开发一种用于胎儿心脏内组织移除的可操纵MEMS仪器。

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.