Intravaginal device for the treatment of pelvic pain and dyspareunia in female cancer survivors

摘要：超过一半的女性癌症幸存者将经历慢性盆腔疼痛和性交困难(疼痛) 性交)由于他们的癌症治疗。随着癌症幸存者的数量继续增长， 需要对这一改变生活的疾病进行有效治疗的妇女人数。盆底理疗师 目前在门诊和家庭治疗期间使用几种不同的设备(阴道扩张器，骨盆魔杖， 振动装置)，但这些装置不受监管，缺乏适当的人体工程学，也不考虑 全面的功能、患者特定的需求以及癌症幸存者常见的身体挑战。 幸存者寻求有效的多式联运解决方案，同时为他们提供知识、技能和 自信地倡导自己的性健康。Cervu公司正在开发一种正在申请专利的阴道内装置 专为癌症女性幸存者的高度个性化需求而设计，专为扩张、振动、 肌筋膜释放，触发点按摩疗法。到目前为止，原型外形系数设计已经是3D的 打印并通过多轮用户测试邮寄给患者和提供者，导致向下选择 以供进一步开发的候选设计。此第一阶段SBIR提案的目标是确认可行性 在候选外形尺寸范围内的功能，并在设计之前获得进一步的用户反馈 冻结进行第一次人体研究。目标1.开发并验证功能阿尔法原型。我们会 与设计和制造合作伙伴协作(1)解决剩余的设计问题，如选择 适当的材料，指定偏心旋转质量振动马达和电气部件，以及 最终确定手柄-扩张器连接机构；(2)制造最小可行产品；以及(3)验证 通过广泛的台架测试，功能与规格相符。目标：(1)设备满足形式和 功能规格包括手柄和扩张器的尺寸和曲率公差，手柄的节距和滚动范围 运动、振动频率、充电速度、视觉指示器、扩张器硬度计、手柄安装/拆卸 力、重量分布和质量一致性；(2)生产满足或超过的5个阿尔法原型 规格。目的2.演示阿尔法原型满足用户需求的能力。我们将验证设计 通过形成性用户测试对10名受试者形成协议，包括盆底理疗师和 患有性交困难的女性癌症幸存者。受试者将收到原型，并将就具体问题接受采访 设备特点以及进行治疗的预期能力。目标：超过80%的用户对每项功能进行评分 利克特评分为5分的≥3。这项拟议的工作有望证明，一个功能强大的设备可以 在确保用户接受的外形尺寸内实施。影响：这款设备有可能 转化性交困难治疗，这是影响女性癌症患者生活质量的最常见情况之一 幸存者。

Summary: More than half of female cancer survivors will experience chronic pelvic pain and dyspareunia (painful intercourse) due to their cancer treatments. As the number of cancer survivors continues to grow, so too will the number of women in need of effective treatments for this life-altering condition. Pelvic floor physical therapists currently use several different devices during in-clinic and at-home therapy (vaginal dilators, pelvic wands, vibration devices) but these devices are unregulated, lack appropriate ergonomics, and do not consider comprehensive functionality, patient-specific needs, and the physical challenges common to cancer survivors. Survivors seek an effective multimodal solution that also provides them with the knowledge, skills, and confidence to advocate for their own sexual health. Cervu, Inc. is developing a patent-pending intravaginal device for the highly individualized needs of female cancer survivors that is uniquely designed for dilation, vibration, myofascial release, and trigger point massage therapies. To date, prototype form factor designs have been 3D printed and mailed to patients and providers through multiple rounds of user testing, resulting in down-selection to a candidate design for further development. The objective of this Phase 1 SBIR proposal is to confirm feasibility of function within the confines of the candidate form factor, and to acquire further user feedback prior to design freeze for first-in-human studies. Aim 1. Develop and validate a functional alpha prototype. We will collaborate with design and manufacturing partners to (1) resolve remaining design questions such as selecting appropriate materials, specifying eccentric rotating mass vibration motor and electrical components, and finalizing the handle-dilator attachment mechanism; (2) manufacture a minimum viable product; and (3) validate function agreement with specifications through extensive bench testing. Goals: (1) Device meets form and function specifications including handle and dilator size and curvature tolerance, handle pitch and roll range of motion, vibration frequency, charging speed, visual indicators, dilator durometer, handle attachment/detachment force, weight distribution, and quality consistency; (2) Production of 5 alpha prototypes that meet or exceed specifications. Aim 2. Demonstrate ability of alpha prototype to meet user needs. We will validate design form agreement through formative user testing in 10 total subjects including pelvic floor physical therapists and female cancer survivors with dyspareunia. Subjects will receive prototypes and will be interviewed on the specific device features as well as anticipated ability to perform therapy. Goal: More than 80% of users rate each feature ≥ 3 on a 5-point Likert scale. The proposed work is expected to demonstrate that a functional device can be implemented within a form factor that ensures user acceptance. Impact: This device has the potential to transform dyspareunia treatment, one of the most common conditions affecting quality of life in female cancer survivors.