Development of Minimally-Invasive Cartilage Reshaping Device

微创软骨重塑装置的研制

• 批准号: 8252944
• 负责人: Joon You
• 金额: $ 15.76万
• 依托单位: PRAXIS BIOSCIENCES, LLC
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-02-10 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8252944
• 关键词: Accounting; Anesthesia procedures; Animal Model; Biological Models; California; Cartilage; Charge; Clinic; Clinical; Clinical Trials; Conventional Surgery; Deformity; Development; Devices; Ear; Electrodes; Environment; Equilibrium; Esthetics; Expenditure; External Ear; Face; Failure; Family suidae; Fees; Fluorescence; Future; Goals; Guidelines; Head; Health Care Costs; Histology; Hospitals; Human; Image; Injury; Institutes; Investigation; Laboratories; Lasers; Left; Legal patent; Length; Life; Measurable; Measures; Mechanics; Methods; Microscopy; Molds; Moulage; Nature; Needles; Nose; Operative Surgical Procedures; Oryctolagus cuniculus; Outcome; Patient Care; Patients; Performance; Phase; Polymers; Process; Property; Recovery; Relative (related person); Relaxation; Reporting; Risk; Risk Factors; Safety; Scanning; Sequential Treatment; Shapes; Skin; Small Business Innovation Research Grant; Specimen; Stress; Surgeon; Surgical sutures; System; Techniques; Technology; Testing; Thick; Time; Tissues; Universities; Validation; Work; airway obstruction; amperage; base; cost; design; design and construction; electric field; electrical potential; graphical user interface; hazard; in vivo; minimally invasive; neurophysiology; novel; operation; patient safety; productivity loss; programs; prototype; quality assurance; research clinical testing; research study; response; rhinoplasty; skills; two-photon; voltage

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.

描述（由申请人提供）：每年有超过600，000例手术进行，以改变耳朵（耳成形术）和鼻子（鼻成形术和鼻中隔成形术）的结构软骨框架的形状，用于功能和美学目的，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雕刻、切割、挤压或粉碎这种粘弹性生物填料， 为了平衡抵抗变形的固有力，将聚合物拉伸成新的期望形状。结果是高度可变的，取决于外科医生的技能和技术。除了与常规外科手术干预相关的常见风险因素之外，由于医院费用和由于患者恢复的停工时间（例如，麻醉手术室费用，过夜）。Praxis Biosciences，LLC旨在开发和提供一种范式转变的微创机电软骨重塑设备，而无需传统“切割和缝合”手术的不必要风险和成本。此外，所提出的技术的微创超低成本性质将允许外科医生随着时间的推移对给定患者进行“滴定”和顺序治疗，以便以测量的逐步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。所提出的设备是基于软骨机械特性响应于低水平、低电流DC电场而改变的事实。疗效已在体内动物模型中得到证实。在第一阶段SBIR提案中，我们将构建并测试用于软骨重塑的临床就绪原型。成功完成后，该设备将用于在未来的第二阶段提案中进行首次试点人体试验。 公共卫生关系：每年有超过60万例手术用于治疗鼻气道阻塞或矫正外耳畸形。这些外科手术 会增加护理成本和患者停工时间。基于软骨的新型机电成型的申报产品将以可承受的成本实现基于办公室的微创治疗。