Electromechanical reshaping of tissue

描述（由申请人提供）：一个多世纪以来，外科医生一直设想不使用手术刀和缝合线来重塑组织。最近，随着多种治疗方式的发展，通过开发新的程序、微创仪器和治疗皮肤和其他组织的创新设备，使这一愿景更接近现实；每一种都利用这些模式的能力来改变组织的内在材料特性。在头颈部，软骨组织是特别有趣的，因为它具有功能和结构作用，包括支持软组织（耳和鼻）、气道通畅（气管）、发声（喉）和关节运动（即TMJ）。由于癌症、创伤或先天性畸形导致的这些器官的缺陷目前是通过“切割缝合”手术来矫正的，这种手术有许多缺点，包括形状记忆、供体部位发病率，通常需要全身麻醉。我们已经开发了机电重塑（EMR），这是一种新颖的微创技术，将机械变形与非常低电流的直流电场的应用相结合。在EMR中，通过夹具将软骨弯曲成新的形状，将铂针电极插入内应力增加的区域，并提供小电流（<25 mA）。夹具被移除，软骨呈现出一个新的稳定形状。EMR是一项新颖而引人注目的技术，它利用软骨的固有特性，通过简单地改变与带电软骨组织基质相互作用的电和化学环境来改变其机械状态。为了推动这项技术的发展，我们的目标是：1)确定EMR过程中形状变化、电压和应用时间之间的关系；2)确定EMR过程中组织损伤程度与电压和施加时间的函数关系；3)在兔体内模型中确定电成型软骨移植物的稳定性、功能和长期行为。与所有新兴的外科技术一样，必须在动物模型中证明其有效性，以激发临床兴趣，并为开展更广泛的基础研究提供合理的动力，重点关注机制和优化。了解EMR后软骨如何愈合、重塑和保持形状将为进一步开发和研究理解、优化和控制这一过程的方法提供动力，并最终迎来一种新的治疗外科方式。EMR是一种优雅、简单、低成本的技术，有可能成为一种临床有用的外科治疗方式，就像Bovie烧刀、外科吻合器或内窥镜在重建手术中普遍存在一样。

DESCRIPTION (provided by applicant): For more than a century, surgeons have envisioned reshaping tissue without the use of scalpels and sutures. Recently, developments with multiple therapeutic modalities have brought this vision closer to reality through development of new procedures, minimally invasive instrumentation, and innovative devices for treating skin and other tissues; each of which exploits the ability of these modalities to alter the intrinsic material properties of the tissue. In the head and neck, cartilage tissue is of particular interest as it serves functional and structural roles, including the support of soft tissue (ear and nose), airway patency (trachea), phonation (larynx), and joint movement (i.e.,TMJ). The defects that result from cancer, trauma, or congenital malformations in these organs are currently corrected by "cut and suture" surgery, which has numerous disadvantages including shape memory, donor site morbidity, and usually general anesthesia. We have developed electromechanical reshaping (EMR), a novel minimally invasive technique that combines mechanical deformation with the application of very low-current DC electric fields. In EMR cartilage is bent into a new shape by a jig, platinum needle electrodes are inserted into regions of increased internal stress, and a small current (<25 mA) is delivered. The jig is removed, and the cartilage assumes a new stable shape. EMR is a novel and compelling technology that exploits the native properties of cartilage to change its mechanical state by simply altering the electrical and chemical milieu that interacts with the charged cartilage tissue matrix. To drive this technology forward, we aim to: 1) determine the relationships between shape change, voltage, and application time during EMR; 2) determine the degree of tissue damage produced during EMR as a function of voltage and application time; and 3) determine the stability, functionality, and long-term behavior of electroformed cartilage grafts in an in vivo rabbit model. As with all emerging surgical technologies, efficacy must be demonstrated in an animal model to fuel clinical interest and provide justifiable motivation to pursue more extensive basic studies focusing on both mechanisms and optimization. Knowing how cartilage heals, remodels, and maintains shape after EMR will provide impetus to further develop and investigate methods to understand, optimize, and control this process and ultimately usher in a new therapeutic surgical modality. EMR is an elegant and simple, low-cost technology, and has the potential to become a clinically useful surgical treatment modality as ubiquitous as the Bovie cautery, surgical stapler, or endoscope in reconstructive surgery. PUBLIC HEALTH RELEVANCE: Deformities of the ear, nose, and airway are common and surgery to correct these disorders requires general anesthesia, incisions, sutures and bleeding. The development of the technology proposed in this grant is aimed at advancing this simple, non-surgical method to reshape tissue in these organs in the face, head, and neck. This technology is potentially simpler, safer, and less expensive than current existing surgical techniques.