Design and Development of Sprayable Surgical Adhesive

描述（由申请人提供）：本项目的长期目标是创建一种可喷涂的外科粘合剂，该粘合剂将满足外科手术对强力、易于使用的粘合剂的需求，以粘合平面组织瓣。这种新型粘合剂将通过消除伤口中的死腔并保持组织处于自然愈合的位置来减少手术后的液体积聚。血清肿形成是最常见的术后并发症之一，在某些外科手术中发生率高达50%。传统的伤口闭合方法（如缝线）提供点对点固定，这不足以完全粘附平面表面。外科医生需要的是一种可喷涂的“胶水”，它可以完全粘附组织的平面皮瓣，而不需要与组织直接接触。拟议的I期研究项目的假设是，Cohera专有的生物相容性聚氨酯组织粘合剂可以设计成一种可喷涂的配方，根据其物理特性、输送过程和粘合强度，该配方可有效闭合平面组织。在手术室环境中通过喷雾输送粘性流体所需的物理限制将需要在产品配方和装置设计方面进行重大创新。为了检验这一假设，将实现以下具体目标：1）优化用于喷雾递送的组织粘合剂的物理特性。简而言之，粘合剂的物理特性（例如粘度、杨氏模量、固化时间和拉伸强度）必须被设计成生产可以在手术室环境中通过喷雾以小体积递送同时满足既定性能要求的粘合剂。2)开发输送装置原型，将粘合剂均匀地喷涂到平面上。将开发一种喷雾尖端，其在附接到注射器递送装置时可以可预测地且可靠地分散粘性流体。3)确定使用喷雾输送系统可以达到足够的粘合强度。将使用新型给药装置对新型制剂进行试验，以确定产品在使用新型给药装置给药时性能充分。在项目的第二阶段，将在体内测试可喷涂粘合剂，以证明其在平面组织闭合和防止术后液体积聚方面的功效。该研究项目将包括最终确定产品规格，包括产品配方和输送装置，在可接受的动物模型中进行血清肿预防的有效性试验，并在人体中进行可行性研究，以向FDA提供数据，支持上市前批准（PMA）。.血清肿形成是最常见的术后并发症之一，在某些外科手术中发生率高达50%。该项目的长期目标是创造一种可喷涂的外科粘合剂，该粘合剂将满足外科手术对牢固、易于使用的粘合剂的需求，以接合平面组织瓣。这种新型粘合剂将通过消除伤口中的死腔并保持组织处于自然愈合的位置来减少手术后的液体积聚。

DESCRIPTION (provided by applicant): The long-term goal of this project is to create a sprayable surgical adhesive which would satisfy the surgical need for a strong, easy-to-use adhesive to adhere planar flaps of tissue. This novel adhesive will reduce fluid accumulation after surgery by eliminating dead space in the wound and maintaining tissues in position for natural healing to occur. Seroma formation is among the most common post-surgical complications, occurring in up to 50% of certain surgical procedures. Traditional wound closure approaches such as sutures provide point-to-point fixation, which is inadequate to fully adhere planar surfaces. What surgeons require is a sprayable "glue" that can fully adhere planar flaps of tissue without requiring direct contact with the tissue. The hypothesis of the proposed Phase I research project is that Cohera's proprietary biocompatible polyurethane tissue adhesive can be engineered into a sprayable formulation that will be effective in closure of planar tissues based on its physical properties, delivery process and adhesive strength. Accommodating the physical constraints required to deliver a viscous fluid by spray in the operating room environment will require significant innovation in both product formulation and device design. To test this hypothesis, the following specific aims will be accomplished: 1) Optimize the physical characteristics of the tissue adhesive for spray delivery. In brief, the physical characteristics of the adhesive (such as viscosity, Young's modulus, cure time and tensile strength) must be engineered to produce an adhesive that can be delivered in small volumes by spray in an operating room environment while meeting established performance requirements. 2) Develop delivery device prototypes to spray adhesive evenly onto planar surfaces. A spray tip will be developed which can predictably and reliably disperse a viscous fluid when attached to a syringe delivery device. 3) Establish that adequate bonding strength can be achieved using spray delivery system. The novel formulation will be tested with the novel delivery device to establish that the product performs adequately when delivered by the new device. During Phase II of the project, the sprayable adhesive will be tested in vivo to demonstrate efficacy in closure of planar tissues and preventing post-surgical fluid accumulation. This research project will include finalizing the product specifications including both product formulation and delivery device, performing efficacy testing in an accepted animal model for seroma prevention, and performing feasibility studies in humans to provide data to the FDA in support of a Pre-market Approval (PMA). . Seroma formation is among the most common post-surgical complications, occurring in up to 50% of certain surgical procedures. The long-term goal of this project is to create a sprayable surgical adhesive which would satisfy the surgical need for a strong, easy-to-use adhesive to coapt planar flaps of tissue. This novel adhesive will reduce fluid accumulation after surgery by eliminating dead space in the wound and maintaining tissues in position for natural healing to occur.