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

总结：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 由于他们的癌症治疗。随着癌症幸存者人数的持续增长， 需要有效治疗这种改变生活的疾病的妇女人数。骨盆底物理治疗师 目前在诊所和家庭治疗期间使用几种不同的装置（阴道扩张器，骨盆棒， 振动装置），但是这些装置不受管制，缺乏适当的人体工程学，并且不考虑 综合功能、患者特定需求以及癌症幸存者常见的身体挑战。 幸存者寻求一种有效的多模式解决方案，同时为他们提供知识、技能和 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 为女性癌症幸存者的高度个性化需求而设计， 肌筋膜松解和触发点按摩疗法。到目前为止，原型形状因子设计已经是3D的 通过多轮用户测试打印并邮寄给患者和提供者，导致向下选择 一个候选设计以供进一步开发。第1阶段SBIR提案的目的是确认可行性 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 用于首次人体研究目标1.开发并验证功能性alpha原型。我们将 与设计和制造合作伙伴协作，以（1）解决剩余的设计问题，如选择 适当的材料，规定偏心旋转质量振动电机和电气部件，以及 最终确定球囊扩张器连接机制;（2）制造最小可行产品;（3）确认 通过广泛的台架测试，功能符合规格。目标：（1）器械符合要求， 功能规范，包括手柄和扩张器尺寸和曲率公差、手柄俯仰和滚动范围 运动、振动频率、充电速度、视觉指示器、扩张器硬度、手柄连接/分离 力、重量分布和质量一致性;（2）生产5个alpha原型，满足或超过 规范.目标2.展示alpha原型满足用户需求的能力。我们将验证设计 通过对10名受试者（包括骨盆底物理治疗师和 患有性交困难的女性癌症幸存者受试者将收到原型，并将接受采访的具体 器械特征以及预期的治疗能力。目标：超过80%的用户对每个功能进行评分 5分制李克特量表≥ 3分。拟议的工作预计将证明，一个功能设备可以 在确保用户接受的形式因素内实现。影响：该器械有可能 转化性交困难治疗，影响女性癌症患者生活质量的最常见疾病之一 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.