Simple & Safe Implantable Device for Treatment of Gastroesophageal Reflux Disease

描述(申请人提供)：这个项目的最终目标是开发一种简单的腹腔镜产品(部分袖套)来治疗胃食道反流病(GERD)或酸反流。在目前通过终生药物控制症状的4000万美国Gerd患者中，至少有450万人将需要额外或替代疗法，另有400万人对他们的药物治疗方案不满意。虽然胃底折叠术是唯一的治愈方法，但其严重性、风险和生理干扰是超过99%的患者采用的障碍。GERD是所有胃肠道疾病中最昂贵的，仅在处方药上每年就花费超过60亿美元，而且这个数字还在增长。由于这个市场的规模，大大小小的公司都开发了许多侵入性较小的、主要是经口腔的内窥镜手术。它们的目的是达到与手术相同的目的，增加下食道括约肌(LES)的约束。这些程序中的大多数都是重大的技术挑战，临床结果不太令人满意，而且没有一个得到广泛采用。部分袖套的设计是在腹腔镜下，通过点击其特殊的放置手柄，简单而直接地将其放置在食道上，从而避免了将胃的一段包裹在食道上的繁琐手术。一旦应用，成形和灵活的部分袖带拥抱食道，并对LES的一部分施加即时约束，类似于Touet部分胃底折叠术。这使得LES的不受约束的部分仍然能够自然打开，例如在吞咽或打嗝时。当组织生长在大约8周内完成时，部分袖套在LES壁中变得完整，进一步赋予其约束作用。这一简单而直接的治疗程序将困扰当前手术和经口腔手术的挑战降至最低。拟议的部分袖带是为了提高生活质量，减轻数百万GERD患者对药物的终身依赖。这反过来将导致国家医疗成本的大幅降低。对于第一阶段，我们建议将我们的概念提升到工作设备上。它们将在台式模型上进行测试，并在活体猪身上进行研究，以验证工作假设，评估生物兼容性，以及设备是否保持在适当的位置。LES的解剖学和病理生理学方面的初步工作已经完成，包括对类似的尿失禁模型进行有限元分析。设备系统的三个部分将如上所述进行工程设计、制造、组装和测试。完成这一第一阶段将使我们能够在临床可行性研究中进一步验证这一点，并在第二阶段满足FDA的许可要求。

DESCRIPTION (provided by applicant): The ultimate goal of this project is to develop a simple laparoscopic product (Partial Cuff) to treat gastroesophageal reflux disease (GERD) or acid reflux. Of the 40 million U.S. GERD sufferers currently manage their symptoms by life-time medications, at least 4.5 million will require additional or alternative remedies, while another 4 million are not satisfied with their medication regimen. Though fundoplication surgery is the only cure, its severity, risks and physiological perturbations are barriers to adoption by over 99% of patients. GERD represents the most expensive of all of the GI diseases, with over $6 billion spent annually just in prescription medications alone, and this number is growing. Because of the size of this market, many less invasive and mostly trans-oral endoscopic procedures have been developed by large and small companies. They aim to achieve the same objective as surgery in increasing the constraints of the lower esophageal sphincter (LES). Most of these procedures represent significant technical challenges with less than satisfactory clinical outcomes and none of them have been widely adopted. Partial Cuff is designed to be placed laparoscopically, simply and directly onto the esophagus with a click of its special placement handle, thereby circumventing the cumbersome surgery of wrapping a segment of the stomach over the esophagus. Once applied, the shaped and flexible Partial Cuff hugs the esophagus and imparts an immediate constraint over a portion of the LES similar to the Toupet partial fundoplication procedure. This allows the unconstrained portion of the LES still be able to open naturally, such as during swallowing or burping. When tissue ingrowth completes in about 8 weeks, the Partial Cuff becomes integral in the LES wall, further imparting its constraining utilit. This simple and direct treatment procedure minimizes challenges plaguing current surgeries and trans- oral procedures. The proposed Partial Cuff is to improve the quality of life and mitigate life-long dependence on medications for millions of GERD sufferers. This in turn will result in a substantial reduction in national healthcare costs. For Phase I, we propose to advance our concept to working devices. They will be tested on a bench top model and in an in vivo pigs study to verify the working hypothesis, assess biocompatibility and whether the device stays in place. Preliminary work has been completed on the anatomy and pathophysiology of the LES including a finite element analysis on an analogous model of urethral incontinence. The three parts of the device system will be engineered, made, assembled and tested as stated above. Completing this Phase I will allow us to further validate this in a clinical feasibility stuy and to fulfill requirements towards FDA allowance in Phase II.