A device to treat high-tone pelvic floor dysfunction in women

摘要 BOLD Type正在开发“SmartWand”，这是一种互动的、联网的盆底系统(设备和 移动应用程序)，指导患者在家中进行盆底理疗(PT)。PT 是治疗高张力盆底功能障碍(HTPFD)的高效和一线药物，HTPFD是导致 慢性盆腔疼痛(CPP)，在美国高达15%的女性受到影响。尽管已经证明了有效性，但只有 20%的妇女完成PT治疗疗程，其中包括家庭锻炼部分和外部锻炼 和内部锻炼养生法。女性报告继续进行PT的限制因素包括时间、成本、获得治疗的机会、 缺乏来自家庭项目的直接反馈，也无法衡量家庭的进展。 Bold Type的团队在医疗器械、质量和监管方面拥有数十年的产品开发经验 婚外情。我们开发了专有硬件和软件开发套件，使我们能够设计和 通过利用可重复使用的子系统高效实施医疗设备，这些子系统旨在 遵守FDA的规定。为了满足对无障碍和改进PT的迫切需求，我们假设： (1)符合人体工程学的棒设计将提高可用性，(2)执行PT的创新系统可以 开发为物理治疗师和患者提供指导和生物反馈；以及(3)患者将被 能够利用平台提供的指导和生物反馈有效地进行PT。 我们为这个项目提出了以下具体目标：1)完成了三个初步的魔杖设计 设计样机时采用人的因素验证测试。三个初步的形成性可用性评估 将在15名有机械棒经验的HTPFD患者中进行棒原型试验，以确定首选 设计特点。我们将在盆底物理治疗师的监督下使用模拟使用测试 使用无电设备原型系统地收集测试参与者的数据；2)开发一种无线设备， 手持“SmartWand”和移动应用程序，(1)记录压力和位置(深度和方向) 女性骨盆相对于盆底肌肉，(2)为用户提供关于棒的音频和视觉反馈 压力、位置和方向，以及(3)将数据传输到数据库以进行存储和分析；以及3)验证 该系统是专门针对10名健康女性和10名HTPFD女性开发的。女人 &gt；18年将被Grace物理治疗和治疗师招募，分配给他们进行压痛 关于魔杖使用的阈值和说明。Aim 3的成功衡量标准是，在应用程序的指导下， 参与者将能够以最小的差异进行魔杖练习，而不是进行测量 通过PT(在施加压力的15%范围内、角度/方向的5度范围内和插入深度的8 mm范围内)。

Abstract Bold Type is developing the “SmartWand”, an interactive, connected pelvic floor system (device and mobile app) to guide patients through pelvic floor physical therapy (PT) in the privacy of their home. PT is a highly effective and first-line treatment for high tone pelvic floor dysfunction (HTPFD), a major contributor to chronic pelvic pain (CPP), affecting up to 15% of women in the United States. Despite proven effectiveness, only 20% of women complete the PT treatment course, which includes a home exercise component with an external and internal exercise regimen. Women report limitations in continuing PT as time, cost, access to therapy, the lack of direct feedback from the home program and the inability to measure progress at home. Bold Type’s team has decades of product development experience with medical devices, quality, and regulatory affairs. We have developed proprietary hardware and software development kits that allow us to design and implement medical devices efficiently by leveraging reusable subsystems that are designed and documented to comply with FDA regulations. To meet the critical need for accessible and improved PT, we hypothesize that: (1) an ergonomic wand design will improve usability, (2) an innovative system for performing PT can be developed that provides guidance and biofeedback to physical therapists and patients; and (3) patients will be able to effectively perform PT using the guidance and biofeedback provided by the platform. We propose the following Specific Aims for this project: 1) Finalize the wand design from three preliminary design prototypes using human factors validation testing. A formative usability evaluation of three preliminary wand prototypes will be conducted in 15 mechanical wand experienced HTPFD patients to identify preferred design features. We will use simulated-use testing under the supervision of a pelvic floor physical therapist and systematically collect data from test participants using the unpowered device prototype; 2) Develop a wireless, handheld “SmartWand” and mobile app that (1) records pressure and location (depth and orientation) in the female pelvis in relation to the pelvic floor muscles, (2) provides the user audio and visual feedback on wand pressure, position, and orientation, and (3) transfers data to a database for storage and analysis; and 3) Validate the system developed in Specific Aim 2 on a group of 10 healthy women and 10 women with HTPFD. Women >18 years will be recruited by Grace Physical Therapy and therapists assigned to perform pressure pain thresholds and instruct on wand use. The success metric for Aim 3 is that with guidance from the app, the participants will be able to perform wand exercises with minimal variance as compared to measurements made by the PT (within 15% of applied pressure, 5 degrees of angle/orientation and within 8 mm of insertion depth).