Multi-Stable Compliant-Mechanism-Based Mattress for Bedsore Prevention

基于多稳定顺应机制的床垫，用于预防褥疮

• 批准号: 10546717
• 负责人: BRAD E. DICIANNO
• 金额: $ 67.32万
• 依托单位: K MEDICAL LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10546717
• 关键词: Address; Affect; Air; American; Area; Back; Beds; Categories; Computer software; Computers; Consumption; Custom; Data; Evaluation; Evaluation Studies; Exhibits; Extravasation; Frequencies; Grant; Height; Inflammation; Injury; Ischemia; Knowledge; Learning; Loudness; Machine Learning; Mattresses; Measures; Medical; Online Systems; Outcome Measure; Patients; Pattern; Persons; Phase; Prevention; Production; Quebec; Recommendation; Reporting; Scourge; Self-Help Devices; Skin Temperature; Somatotype; System; Testing; Thick; Tissues; United States National Aeronautics and Space Administration; Wheelchairs; Work; Workload; aging population; base; cost; decubitus ulcer; design; indexing; manufacturing process; pressure; prevent; primary outcome; prototype; research clinical testing; satisfaction; sensor; smartphone Application; tool; usability

Abstract Pressure injuries (i.e., bedsores) affect 2.5 million Americans every year and 60,000 die from them. Although several commercial alternating-pressure and low air-loss mattress products already exist to address this scourge, these products are not optimally effective and lack the evidence to deserve a strong medical recommendation. Moreover, they are expensive, heavy, and loud, and can exhibit lack of air- permeation, air leakage issues, and round-the-clock power consumption. We propose a multi-stable compliant-mechanism-based (MSCMB) mattress to overcome these issues and optimally prevent prolonged levels of harmful pressure in the existing immobile and aging population. During Phase I of our current grant, which began May 1st, 2021, we successfully fabricated a bed that consists of 1,260 linear actuator pistons that can be controlled by a computer to impart any undulating pressure pattern on a patient’s back. By the end of Phase I (April 30th, 2022), we will have used this bed to complete a study, which involves machine learning to determine (i) what factors predominantly affect bedsore prevention in alternating pressure approaches, and (ii) what the optimal height of (i.e., amplitude) and distance between (i.e., pitch) each pressure peak should be for different categories of patients. We will use this information to inform the design of the final products that will be prototyped and perfected in Phase II. During Phase I, we also generated a MATLAB tool that was used to design a large portion of our proposed MSCMB mattress concept and have prototyped it to demonstrate its functionality and to collect preliminary data. The design tool and the lessons learned during the fabrication and testing of the prototype will be heavily leveraged in Phase II to successfully perform the proposed aims. These aims are to (i) create the final MSCMB mattress products that best reduce pressure injuries for different categories of patients, (ii) produce a smart phone app and a web-based computer software that can be used to remotely set the switching frequency of the actuated versions of the MSCMB mattress designs, (iii) conduct a study to identify the most effective kind and thickness of foam pad to use on top of each MSCMB mattress product, (iv) determine and perfect the final process for manufacturing the MSCMB mattresses, and (v) perform a user evaluation study of the MSCMB mattress products.

摘要 压力伤害（即，褥疮）每年影响250万美国人，6万人死于褥疮。 尽管已经存在几种商用的交变压力和低空气损失床垫产品， 解决这一祸害，这些产品不是最佳的有效性，缺乏证据，值得一个强有力的 医疗建议。此外，它们昂贵、沉重、吵闹，并且可能表现出缺乏空气- 渗透、漏气问题和全天候功耗。我们提出了一个多稳态 基于顺应性机制（MSCMB）的床垫，以克服这些问题，并最佳地防止 现有的不流动和老龄化人口长期承受有害压力。在第一阶段， 目前的赠款，开始2021年5月1日，我们成功地制作了一张床，包括1,260线性 致动器活塞可以由计算机控制，以将任何波动的压力模式施加在 病人的背部。到第一阶段结束时（2022年4月30日），我们将使用这张床完成一项研究， 其涉及机器学习以确定（i）哪些因素主要影响褥疮预防， 交变压力接近，以及（ii）最佳高度（即，振幅）和距离 (i.e.,音高）每个压力峰值应当针对不同类别的患者。我们将使用以下信息 为最终产品的设计提供信息，最终产品将在第二阶段进行原型制作和完善。在第一阶段， 我们还生成了一个MATLAB工具，用于设计我们提出的MSCMB的大部分 床垫的概念，并已原型，以证明其功能，并收集初步数据。 设计工具和在原型制造和测试过程中吸取的经验教训将在很大程度上 在第二阶段中，成功地实现了拟议的目标。这些目标是：（一）创造最后的 MSCMB床垫产品最能减少不同类别患者的压力损伤，（ii） 开发一个智能手机应用程序和一个基于网络的计算机软件，可以用来远程设置 MSCMB床垫设计的致动版本的切换频率，（iii）进行研究， 确定在每个MSCMB床垫产品上使用的最有效的泡沫垫类型和厚度， (iv)确定并完善制造MSCMB床垫的最终工艺，以及（v）执行 MSCMB床垫产品的用户评价研究。