Simple & Safe Implantable Device for Treatment of Gastroesophageal Reflux Disease

简单的

• 批准号: 8590618
• 负责人: Claude NMN Tihon
• 金额: $ 19.11万
• 依托单位: CT RESOURCES, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-01 至 2014-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8590618
• 关键词: Acids; Adopted; Adoption; Adverse effects; Adverse event; Affect; Anatomy; Animals; Autopsy; Caliber; Clinical; Contracts; Country; Deglutition; Dependence; Development; Devices; Disease; Engineering; Esophagus; Evaluation; Family suidae; Finite Element Analysis; Functional disorder; Fundoplication; Gastroesophageal reflux disease; Gastrointestinal Diseases; Glues; Goals; Government; Health Care Costs; Histocompatibility; Human; Implant; Incontinence; Inferior esophageal sphincter structure; Life; Marketing; Measurement; Measures; Medication Management; Modeling; Operative Surgical Procedures; Oral; Organ; Outcome; Patients; Persons; Pharmaceutical Preparations; Phase; Physiological; Plague; Polypropylenes; Procedures; Quality of life; Reflux; Regimen; Resources; Risk; Sampling; Severities; Shapes; Silicones; Simulate; Small Business Innovation Research Grant; Sphincter; Sterility; Stomach; Surgeon; Symptoms; System; Testing; Time; Tissues; Urethra; Vendor; Vision; Work; base; biomaterial compatibility; cost; design; ergonomics; flexibility; implantable device; improved; in vivo; meetings; nitinol; pressure; prototype; public health relevance; repaired; success

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.

描述（由申请人提供）：本项目的最终目标是开发一种简单的腹腔镜产品（部分袖带），用于治疗胃食管反流病（GERD）或酸反流。目前，在美国4000万GERD患者中，至少有450万人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疗方法，但其严重性，风险和生理扰动是超过99%的患者采用的障碍。GERD是所有胃肠道疾病中最昂贵的，每年仅处方药就花费超过60亿美元，而且这个数字还在增长。由于这个市场的规模，许多较小的侵入性和大多数经口腔内窥镜手术已经由大型和小型公司开发。他们的目标是达到与手术相同的目的，增加下食管括约肌（LES）的限制。这些手术中的大多数代表了重大的技术挑战，临床结局不太令人满意，并且没有一种被广泛采用。部分袖带设计用于在腹腔镜下简单直接地放置在食管上，只需点击其特殊的放置手柄，从而避免了将胃段包裹在食管上的繁琐手术。一旦应用，成形和柔性的部分套囊就可以包裹食管，并对LES的一部分施加直接约束，类似于Toupet部分胃底折叠术。这允许LES的不受约束的部分仍然能够自然地打开，例如在吞咽或打嗝期间。当组织长入在约8周内完成时，部分袖带在LES壁中成为整体，进一步赋予其约束作用。这种简单而直接的治疗过程最大限度地减少了目前手术和经口手术的挑战。申报的部分袖带旨在改善数百万GERD患者的生活质量并减轻其对药物的终身依赖。这反过来又将导致国家医疗保健费用的大幅降低。对于第一阶段，我们建议将我们的概念推广到工作设备。将在实验室模型和体内猪研究中对其进行测试，以验证工作假设，评估生物相容性以及器械是否保持原位。初步工作已经完成的LES的解剖学和病理生理学，包括一个类似的模型尿道失禁的有限元分析。器械系统的三个部分将按照上述进行设计、制造、组装和测试。完成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，并满足FDA在第二阶段的要求。