Evaluation of a Robotic Assisted Surgical System for Hearing Loss

听力损失机器人辅助手术系统的评估

• 批准号: 9346740
• 负责人: Allan Henslee
• 金额: $ 70.96万
• 依托单位: IOTAMOTION, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-04-06 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9346740
• 关键词: Acoustics; Address; Aging; Animal Model; Animal Testing; Animals; Area; Automobile Driving; Biological Preservation; Cadaver; Capital; Clinical; Clinical Trials; Clinical Trials Design; Cochlea; Cochlear Implants; Cochlear implant procedure; Data; Development; Devices; Ear; Electrodes; Ensure; Environment; Evaluation; Funding; Goals; Gold; Health; Hearing; Histology; Human; Implant; Implantation procedure; In Vitro; Incidence; Individual; Instruction; International; Investments; Letters; Manuals; Modeling; Operative Surgical Procedures; Outcome; Patient-Focused Outcomes; Patients; Phase; Positioning Attribute; Postoperative Period; Private Sector; Procedures; Production; Productivity; Property; Quality of life; Recording of previous events; Residual state; Risk; Robotics; Safety; Secure; Sheep; Small Business Innovation Research Grant; Sterilization; Surgeon; System; Systems Development; Techniques; Technology; Testing; Trauma; Work; base; biomaterial compatibility; commercialization; design; experience; experimental study; hearing impairment; implantation; improved; in vivo; man; microCT; prospective; prototype; research and development; robot control; seal; success

Abstract: Since their clinical introduction over 30 years ago, cochlear implants (CIs) have had a remarkable impact on patients experiencing moderate-to-profound hearing loss. Recent advances in technology have driven the development of “hearing preservation” implants and procedures designed to preserve the residual acoustic hearing of patients while treating the damaged areas of the ear with an electrically stimulated CI. Despite these advances, over half of patients undergoing this procedure will eventually lose residual hearing months to years after surgery likely due to cochlear trauma sustained during the surgery. Additionally, because current techniques do not allow the electrode to be inserted farther into the cochlea to reach now dysfunctional regions, patients either require additional surgery or live with suboptimal hearing once again. iotaMotion is developing an implantable robotic-assisted positioning system to enable precise control of intracochlear electrodes both intra- and post-operatively to reduce the effects of post-surgical hearing loss. The anticipated impact of this technology will be to improve the long-term outcomes of patients undergoing “hearing preservation” cochlear implantation as well as increase the candidacy range for this procedure. The overall goal of this Direct-to-Phase II SBIR project is to further develop and ultimately commercialize iotaMotion's proprietary technology. During “Phase I-equivalent SBIR” studies, iotaMotion developed and characterized an initial prototype to establish proof of concept and feasibility in cadaveric models. Following that success, Phase II will continue to develop the technology toward commercialization with the following specific aims: 1) Verify device compatibility and “open” platform with commercially available cochlear implants . Using 3 clinically available electrodes, we will establish the procedure, instructions, and ease of use for integrating each electrode within the device, then determine the maximum stall force that can occur with each device/electrode combination. 2) Establish that the iotaMotion pilot-line system meets functional, quality, safety, and biocompatibility requirements in a GLP environment. Using a combination of international standards and in-house experiments, we will demonstrate that the device can be sterilized, is biocompatible, and can remain functional in the body for up to 6 months. Quality standards will be implemented to ensure valid data are collected for eventual regulatory submission. 3) Evaluate the efficacy of the iotaMotion robotic-assisted surgical system in a long-term large-animal model. Phase II will conclude with an evaluation of the device efficacy in an established sheep model over 3 months. Completing these aims will set the stage for our system development and production in a GMP environment with private-sector partnering and execution of a prospective clinical trial designed to establish safety and efficacy in humans. The phase II project enables iotaMotion to achieve significant commercialization milestones, driving the company forward toward improving the hearing and quality of life for millions worldwide.

摘要：人工耳蜗术自30多年前临床应用以来，取得了令人瞩目的成就。 对经历中度至重度听力损失的患者的影响。最近的技术进步使 推动“听力保护”植入物和程序的发展，以保护残留物 患者在使用电刺激CI治疗耳部受损区域时的听力。 尽管取得了这些进展，但接受这种手术的患者中，超过一半的人最终会失去残余听力。 手术后几个月到几年，可能是由于手术中遭受的耳蜗伤。另外，因为 目前的技术不允许将电极进一步插入耳蜗处以达到现在的功能障碍 在不同的地区，患者要么需要额外的手术，要么再次生活在听力不佳的情况下。ItaMotion是 开发一种植入式机器人辅助定位系统，以实现对 术中和术后应用耳廓内电极减少术后听力的影响 损失。这项技术的预期影响将是改善患者的长期结果 做“听力保留型”人工耳蜗植入术并扩大候选范围 这一过程。这个直接到第二阶段的SBIR项目的总体目标是进一步开发和最终 将iotaMotion的专有技术商业化。在“第一阶段-相当于SBIR”的研究中，iotaMotion 开发和表征一个初始原型，以在身体上建立概念和可行性的证明 模特们。在取得成功后，第二阶段将继续开发该技术，以实现商业化 以下具体目标：1)验证设备兼容性并与商业上的“开放”平台 可供选择的人工耳蜗。使用3个临床可用的电极，我们将建立该程序， 说明和集成设备内每个电极的易用性，然后确定最大值 每个器件/电极组合可能产生的失速力。2)建立iotaMotion试点线路 系统满足GLP环境中的功能、质量、安全和生物兼容性要求。 使用国际标准和内部实验相结合的方式，我们将证明该设备 可以灭菌，具有生物相容性，并可在体内保持功能长达6个月。质量标准 将被实施，以确保收集到有效的数据，以便最终提交监管机构。 3)评估 ItaMotion机器人辅助手术系统在长期大动物模型中的有效性。第二阶段 将在3个月内对该装置在已建立的绵羊模型中的疗效进行评估。 完成这些目标将为我们在GMP环境下开发和生产系统奠定基础 与私营部门合作并执行一项前瞻性临床试验，旨在建立安全性和 对人类的功效。第二阶段项目使iotaMotion能够实现重大商业化 里程碑，推动公司朝着改善全球数百万人的听力和生活质量的方向前进。