Linear Lesion Device

描述(申请人提供)：心房颤动是一种电性 心脏上泵房故障导致重大医疗事故 以及生活方式的问题。目前的治疗方法是药物(副作用 和最小的有效性)，起搏器(在摧毁电气系统之后 心脏，价格昂贵，效果适中)，电隔离 使用迷宫程序的心脏区域-外科手术切割心脏和 缝合在一起产生疤痕组织以阻止故障的电 小路。这个迷宫程序被证明几乎百分之百有效， 然而，这是一个漫长且异常困难的过程。由于前景看好的概念， 这种方法正在积极地研究，使用消融导管和 用探头来制造损伤。然而，为了隔离电路径，一个完整的 必须在组织中制造电块，而这些技术是有限的 他们制造跨壁损伤的能力。有了这些技术， 会发生烧焦和广泛的心房损伤，这可能会增加中风的风险。 我们的技术通过将射频双极能量整合到 该设备将快速而安全地创建跨壁线性损伤，从 心内膜至心外膜，单次应用，同时保护 周围的组织。在第一阶段，我们将制造一个原型并评估我们的 穿壁损伤和电隔离组织的能力。 建议的商业应用： 我们的技术将克服目前治疗心房颤动(房颤)方法的局限性，并可用于在心内直视手术期间治疗房颤，并减少术后房颤发作的发生。仅这个市场每年就超过1.2bb美元。使用这种技术开发的设备有很大的潜力被纳入微创程序中，为市场潜力增加1.5美元。

DESCRIPTION (provided by applicant): Atrial Fibrillation is an electrical malfunction of the upper pumping chambers of the heart causing major medical and lifestyle problems. The current treatments are pharmaceutical (side effects and minimal effectiveness), pacemakers (after destroying the electrical system of the heart, expensive and moderately effective), and electrically isolating areas of the heart using the MAZE procedure - surgically cutting the heart and sewing back together creating scar tissue to block malfunctioning electrical pathways. This MAZE procedure has proven to be nearly 100 percent effective, however it is long and extraordinarily difficult. Due to the promising concept, this approach is aggressively being investigated using ablation catheters and probes to create lesions. However, to isolate electrical pathways, a complete electrical block in the tissue must be made and these technologies are limited in their ability to create transmural lesions. With these technologies, charring and extensive atrial damage occur, which can increase risk of stroke. Our technology addresses these issues by incorporating RF Bipolar energy into a device that will quickly and safely create a transmural linear lesion, from endocardium to epicardium, in a single application while protecting the surrounding tissue. In Phase I we will fabricate a prototype and evaluate our lesions for transmurally and ability to electrically isolate tissue. PROPOSED COMMERCIAL APPLICATION: Our technclogy will overcome the limitations of the current methods of treating atrial fibrillation (AF) and can be used to treat AF during open-heart procedures and to reduce the occurrence of post-operative AF episodes. This market alone exceeds $1.2 BB/year. The devices that can be developed using this technology have a strong potential of being incorporated into minimally invasive procedures adding an additional $1.5 BB to the market potential.