Comprehensive Positioning Management System

描述（由申请人提供）： Vesticon, Inc. 正在开发一种针对前庭疾病位置表现的综合评估和管理系统（综合位置管理系统）（CPM 系统），以应用于医疗和研究机构。头晕和平衡障碍是美国医疗保健中最常见的问题之一，有 620 万年龄在 40 岁至 69 岁之间的美国人长期受到头晕和平衡障碍的影响，其中大多数 70 岁以上的人都存在平衡问题，其中与平衡相关的跌倒占老年人意外死亡的一半以上。最常见的前庭疾病是良性阵发性位置性眩晕（BPPV）。目前可用的诊断和患者护理管理协议限制了最佳医疗护理和预防不良后果（包括老年人跌倒）。此外，现有的医疗技术是在 BPPV 被充分理解之前开发的，因此在诊断效用方面受到限制，并且不是最佳的，也没有被 FDA 批准用于治疗。 拟议的 CPM 系统将利用能够安全地对 BPPV 及其变异患者进行自动定位和体位操作的技术。它将在所有三个旋转维度上进行此操作，并且与 3D 记录相结合，将允许对具有平衡问题最常见原因的患者进行定量和一致的评估和治疗。 最近，多轴椅子原型的重新设计第一阶段工作已经完成，其中3D运动控制和额外的3D眼动分析系统与用于交互式显示和控制的基本软件组件集成。所有第一阶段目标均已达到或超过。 在第二阶段，我们将制定： a) 使用原始原型的 1000 份患者记录，并与独立专家审查协商，并遵循循证方法，制定诊断、治疗和随访监测方案； b) 实施协议、图形用户界面、打印报告和数据存储/检索以及专家决策支持系统的软件； c) 用户可选择决策支持系统推荐的操作自动化级别； d) 更轻、可运输的 CPM 系统硬件生产模型。最后，我们将在 PL 诊所和三个独立的 beta 站点展示改进的临床应用，以在大量受试者群体中进行人体研究。

DESCRIPTION (provided by applicant): Vesticon, Inc. is developing a comprehensive evaluation and management system for positional manifestations of vestibular disorders (Comprehensive Positional Management System) (CPM System) for application at medical and research facilities. Dizziness and balance disorders are among the most common problems in US healthcare, with 6.2 million chronically affected Americans between ages 40 and 69, and a majority of those over age 70 reporting balance problems, where balance-related falls account for more than half of the accidental deaths in the elderly. The most common vestibular disorder is Benign Paroxysmal Positional Vertigo (BPPV). Currently available diagnostic and patient care management protocols limit optimal medical care and prevention of untoward consequences, including falls in the elderly. In addition, existing medical technology was developed before BPPV was well understood, and is therefore limited in diagnostic utility and not optimal, nor cleared by the FDA, for treatment. The proposed CPM System will utilize technology that can safely carry out automated positioning and positional maneuvers in patients with BPPV and variants. It will do so in all three rotational dimensions, and, coupled with 3-D recordings, will permit quantitative and consistent evaluation and treatment of patients with the most common causes of balance problems. Recently, Phase I work for the re-engineering of the prototype multi-axial chair was completed, where 3-D motion control and an additional 3-D eye movement analysis system were integrated with basic software components for interactive display and control. All Phase I goals were met or exceeded. During Phase II, we will develop: a) protocols for diagnosis, treatment and follow-up monitoring using the original prototype's 1000+ patient records in consultation with independent expert review, and subject to evidence-based methodology; b) software to implement protocols, graphical user interfaces, printed reports and data storage/retrieval and expert decision-support system; c) user-selectable levels of automation of maneuvers recommended by the decision support system; and d) a lighter, transportable production model of the CPM System hardware. Finally, we will demonstrate improved clinical applications at the Pl's clinic and three independent beta sites to carry out human studies in a large subject population.