Manual Control of the Upper Esophageal Sphincter

食管上括约肌的手动控制

• 批准号: 8257912
• 负责人: Peter Belafsky
• 金额: $ 33.47万
• 依托单位: UNIVERSITY OF CALIFORNIA AT DAVIS
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-15 至 2015-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8257912
• 关键词: Adverse effects; Affect; Alzheimer' s Disease; American; Amyotrophic Lateral Sclerosis; Aspiration Pneumonia; Biomechanics; Bolus Infusion; Cartilage; Cessation of life; Chronic; Clinical Research; Clinical Trials; Craniocerebral Trauma; Cricoid cartilage structure; Deglutition; Deglutition Disorders; Dehydration; Device Removal; Devices; Diet Modification; Disease; Elderly; Excision; Functional disorder; Goals; Head and Neck Cancer; Health Expenditures; High Prevalence; Human; Implant; Incidence; Individual; Infection; Injury; Investigation; Larynx; Lead; Malnutrition; Manuals; Medical Device; Modeling; Morbidity - disease rate; Multiple Sclerosis; Muscle; Muscular Dystrophies; Myasthenia Gravis; Operative Surgical Procedures; Oropharyngeal Dysphagia; Parkinson Disease; Patients; Penetration; Pharyngeal structure; Phase; Pseudobulbar Palsy; Quality of life; Research; Risk; Safety; Sheep; Stroke; Testing; Therapeutic; Time; Tissues; Translational Research; United States National Institutes of Health; Upper Esophageal Sphincter; base; body system; feeding; follow-up; improved; innovation; mortality; novel; public health relevance; therapy design

DESCRIPTION (provided by applicant): Dysphagia, or difficulty swallowing, is a devastating disorder that affects over 10 million Americans each year. Untreated dysphagia can lead to dehydration, malnutrition, aspiration pneumonia, and death. The overall goal of this project is to develop innovative, new treatment options for patients with profound dysphagia via clinical and translational research. Although there have been great advances in medical devices for other organ systems, there is currently no device available to assist with the act of deglutition. Current therapeutic options include swallowing therapy, diet modification, non-oral feeding and invasive surgery. Regardless of our best efforts, these treatments fail in a significant percentage of individuals. The particular hypothesis of this proposal is that long-term profound oropharyngeal dysphagia (OPD) can be treated by manually opening the upper esophageal sphincter (UES). The hypothesis will be tested with an ovine model of OPD and a swallow expansion device that manually opens the UES. The specific aims of the proposal are to determine: 1) the force necessary to maximally open the UES by pulling the cricoid cartilage anteriorly; 2) sustained improvement in swallowing by manual opening of the UES with the swallow expansion device; 3) damage to the cricoid cartilage or adjacent tissue and organ systems as evidenced by injury or infection with use of the swallow expansion; and 4) safe removal of the swallow expansion device without damage to the cricoid cartilage or adjacent tissues. At the completion of these studies, it will have been rigorously determined whether manual opening of the UES is safe and efficacious for treating OPD. Results from this proposal will impact the research field through increased understanding of how the cricoid cartilage responds to the biomechanical force necessary to treat OPD, leading to innovative and optimally designed therapy. If the results are positive, this investigation will form the basis for Phase I human clinical trials. PUBLIC HEALTH RELEVANCE: Oropharyngeal dysphagia is a devastating swallowing disorder associated with a high degree of morbidity and mortality. Although there have been great advances in medical devices for other organ systems, there is currently no device available to assist with the act of swallowing. We propose to study a novel medical device, the swallow expansion device, to treat this devastating disorder in a sheep model of oropharyngeal dysphagia, which if successful, will establish the basis for human clinical trials.

描述（由申请人提供）：吞咽困难或吞咽困难是一种毁灭性的疾病，每年影响超过 1000 万美国人。未经治疗的吞咽困难可导致脱水、营养不良、吸入性肺炎和死亡。该项目的总体目标是通过临床和转化研究为患有严重吞咽困难的患者开发创新的新治疗方案。尽管用于其他器官系统的医疗设备已经取得了巨大进步，但目前还没有可用于辅助吞咽行为的设备。目前的治疗选择包括吞咽治疗、饮食调整、非经口喂养和侵入性手术。尽管我们尽了最大努力，这些治疗在很大一部分人身上还是失败了。该提案的具体假设是，可以通过手动打开食管上括约肌（UES）来治疗长期严重口咽吞咽困难（OPD）。该假设将通过 OPD 绵羊模型和手动打开 UES 的吞咽扩张装置进行测试。该提案的具体目标是确定：1​​）通过向前拉动环状软骨来最大程度地打开 UES 所需的力； 2) 通过使用吞咽扩张装置手动打开 UES 来持续改善吞咽； 3) 使用吞咽扩张器导致环状软骨或邻近组织和器官系统损伤或感染； 4)安全移除吞咽扩张装置而不损伤环状软骨或邻近组织。这些研究完成后，将严格确定手动打开 UES 对于治疗 OPD 是否安全有效。该提案的结果将通过加深对环状软骨如何响应治疗 OPD 所需的生物力学力的理解来影响研究领域，从而带来创新和优化设计的治疗方法。如果结果是积极的，这项研究将成为一期人体临床试验的基础。 公共卫生相关性：口咽性吞咽困难是一种破坏性吞咽障碍，发病率和死亡率很高。尽管用于其他器官系统的医疗设备已经取得了巨大进步，但目前还没有可用于辅助吞咽行为的设备。我们建议研究一种新型医疗设备，即吞咽扩张装置，以在绵羊口咽吞咽困难模型中治疗这种破坏性疾病，如果成功，将为人体临床试验奠定基础。