Development of novel, biophysically designed fluids for swallowing disorders

描述(申请人提供)：吞咽障碍，称为吞咽困难，与死亡率和发病率增加有关，包括营养不良、脱水、肺部并发症和生活质量下降。超过1800万成年人(以及数百万儿童)患有吞咽困难。吞咽困难通常会导致吞咽过程中吸入或误导稀薄的液体(如水、咖啡)进入呼吸道，导致吸入性肺炎的重大风险。在过去十年中，以吸入性肺炎为主要诊断的医疗保险受益人的出院率上升了93.5%；住院时间和死亡率也增加了。治疗老年人肺炎每年的医疗费用为44亿美元，肺炎每年导致急诊室、医院和诊所就诊450万人次。粘度较大(“较稠”)的液体不太可能进入呼吸道，因为它们比稀液体移动得更慢、更有凝聚力，从而有更多的时间进行充分的呼吸道保护。吞咽困难的诊断包括对吞咽机制进行动态放射学(透视)评估，使用含硫酸钡颗粒的不透射线的液体。成功的吞咽困难治疗策略包括使处方的饮食增稠液体与标准化诊断钡混合物的流变学参数相匹配。然而，目前可用的膳食液体与诊断液体的流变特性不匹配，导致诊断和治疗实践之间的严重脱节。这使患者面临更大的吸入和吞咽困难相关的负面健康后遗症(如肺炎)的风险。此第一阶段SBIR提交的目标是开发稳定、可安全吞咽、吸引人的水化液体，并具有与标准化诊断钡产品一致的预先确定的流变性。这一目标分为两个任务：(1)开发满足确定的流变学标准(表观粘度、流动行为和表观屈服应力)并与商业上可用的诊断标准相匹配的六种流体原型；(2)评估原型的货架期(流变学稳定性和感官变化)、吞咽安全性和感官感知(后两项在人体中)。燕子解决方案有限责任公司拥有填补临床需求和现有产品之间差距的知识和技能，并开发新产品，为吞咽困难患者提供足够的水分和营养，并避免与抽吸相关的严重且代价高昂的健康问题。这一专家多学科团队处于理想的位置，通过为吞咽困难患者开发商业上可用的、生物物理设计的、基于科学的液体，为临床实践建立科学基础。

DESCRIPTION (provided by applicant): Swallowing disorders, known as dysphagia, are associated with increased mortality and morbidity, including malnutrition, dehydration, pulmonary complications, and reduced quality of life. More than 18 million adults (and millions more children) suffer from dysphagia. Dysphagia commonly causes thin liquids (e.g., water, coffee) to be aspirated or misdirected into the airway during swallowing, leading to significant risk of aspiration pneumonia. Rates of hospital discharge for Medicare beneficiaries with aspiration pneumonia as a primary diagnosis have risen by 93.5% in the last decade; the length of hospital stay and death rates has also increased. Annual healthcare costs of treating pneumonia in elders are $4.4 billion and pneumonia is responsible for 4.5 million visits to Emergency Rooms, hospitals, and clinics annually. Liquids that are more viscous ("thicker") are less likely to enter the airway because they move more slowly and cohesively than thin liquids allowing more time for sufficient airway protection. Dysphagia diagnosis involves undergoing a dynamic radiographic (fluoroscopic) evaluation of the swallowing mechanism, using fluids made radiopaque with barium sulfate particles. Successful dysphagia management strategy involves having prescribed dietary thickened liquids match the rheological parameters of the standardized diagnostic barium mixtures. However, currently available dietary liquids do not match the rheological characteristics of the diagnostic fluids, causing a critical disconnect between diagnosis and treatment practices. This disconnects places patients at greater risk for aspiration and dysphagia-related negative health sequelae (e.g., pneumonia). The goal of this Phase I SBIR submission is to develop fluids for hydration that are stable, safe to swallow, appealing, and possess pre-determined rheological properties consistent with standardized diagnostic barium products. This Aim is divided into two tasks: (1) Develop six fluid prototypes that meet identified rheological criteria (apparent viscosity, flow behavior and apparent yield stress) and match commercially available diagnostic standards and (2) Evaluate prototypes for shelf-life (rheological stability and organoleptic changes), swallowing safety and sensory perception (the latter two in human subjects). Swallow Solutions LLC has the knowledge and skills to bridge the gap between clinical need and existing products and to develop new products to provide dysphagic patients with adequate hydration and nutrition and to avoid the serious, costly health problems associated with aspiration. This expert multi-disciplinary team is ideally positioned to build the scientific foundation for clinical practice by developing commercially available, biophysically-designed, scientifically-based fluids for individuals with dysphagia.