Development of Minimally-Invasive Cartilage Reshaping Device

描述(申请人提供)：每年进行超过60万例手术，以改变耳(耳成形术)和鼻(鼻成形术和鼻中隔成形术)的结构软骨框架的形状，以达到功能和美观的目的，支出超过10亿美元。目前重塑头部、面部和上呼吸道软骨的方法需要切割、切割、缝合或粉碎这种粘弹性生物电荷。 将聚合物制成新的所需形状，以平衡抵抗变形的先天力量。结果是高度可变的，取决于外科医生的技能和技巧。除了与传统手术干预相关的常见风险因素外，由于住院费用和患者停机恢复时间(例如，麻醉费、手术费、过夜住宿)造成的生产力损失，医疗保健成本增加。Praxis Biosciences，LLC的目标是开发和提供一种范式转换的微创机电软骨重塑设备，而不需要传统“切割和缝合”手术的不必要的风险和成本。此外，拟议技术的微创超低成本性质将允许外科医生对给定的患者进行滴定和随着时间的推移进行连续治疗，以便以有节制的步进式方式改变面部软骨形状，避免传统手术发生的剧烈和明显的变化。所提出的装置是基于这样一个事实，即软骨的机械性能随着低水平、小电流的直流电场的响应而改变。有效性已经在活体动物模型中得到了证明。在这一阶段的SBIR方案中，我们将构建并测试一个可用于临床的软骨重塑原型。在成功完成后，该装置将用于在未来的第二阶段提案中进行第一次试点人体试验。 与公共卫生相关：每年有60多万例手术用于治疗鼻道阻塞或矫正外耳畸形。这些外科手术干预 可能会增加护理成本和患者停机时间。拟议的产品基于一种新的软骨机电成型技术，将以负担得起的成本实现基于办公室的微创治疗。

DESCRIPTION (provided by applicant): Every year, more than 600,000 operations are performed to alter the shape of the structural cartilage frameworks of the ear (otoplasty) and nose (rhinoplasty and septoplasty) for both functional and aesthetic purposes, accounting for more than $1 billion in expenditure. Current methods of reshaping cartilage in the head, face and upper airway require carving, cutting, suturing, or crushing this viscoelastic biologic charged polymer into a new desired shape in order to balance the innate forces that resist deformation. The results are highly variable and dependent on the skills and techniques of the surgeon. In addition to the usual risk factors related to conventional surgical interventions, there is an increased healthcare cost due to hospital expenses and loss of productivity due to patient down-time for recovery (e.g., anesthesia, O.R. fees, overnight stays). Praxis Biosciences, LLC aims to develop and deliver a paradigm-shifting minimally-invasive electromechanical cartilage re-shaping device without the unnecessary risks and costs of traditional "cut and suture" surgery. In addition, the minimally invasive ultra low-cost nature of the proposed technology will allow surgeons to "titrate" and perform sequential treatments over time on a given patient in order to alter facial cartilage shape in a measured step-wise fashion, avoiding drastic and noticeable changes that occur with conventional surgery. The proposed device is based on the fact that cartilage mechanical properties change in response to low-level, low-current DC electric fields. Efficacy has already been demonstrated in vivo animal models. In this phase I SBIR proposal, we will build and test a clinic-ready prototype for cartilage re-shaping. Upon successful completion, the device will be used to carry out a first pilot human trial in future Phase II proposals. PUBLIC HEALTH RELEVANCE: More than 600,000 operations are performed each year to treat nasal airway obstruction or to correct external ear deformities. These surgical interventions can add to the cost of care and patient down-time. The proposed product based on a novel electro-mechanical forming of cartilage will enable office-based minimally- invasive treatments at affordable cost.