Design and Development of Sprayable Surgical Adhesive

描述(申请人提供)：该项目的长期目标是创造一种可喷雾的手术粘合剂，以满足外科手术对粘合平面组织瓣的强力、易用粘合剂的需要。这种新型粘合剂将通过消除伤口中的死腔和保持组织处于自然愈合的位置来减少手术后液体的积累。浆膜瘤形成是最常见的术后并发症之一，在某些外科手术中发生的比例高达50%。传统的伤口闭合方法，如缝合，提供点对点固定，这不足以完全粘连平面表面。外科医生需要的是一种可以完全粘合平面组织瓣而不需要与组织直接接触的可喷雾“胶”。拟议的第一阶段研究项目的假设是，Cohera专有的生物兼容聚氨酯组织粘合剂可以被设计成一种可喷雾的配方，根据其物理特性、输送过程和粘合强度，将有效地封闭平面组织。要适应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设备设计方面进行重大创新。为了验证这一假设，将实现以下具体目标：1)优化用于喷雾输送的组织粘合剂的物理特性。简而言之，胶粘剂的物理特性(如粘度、杨氏模数、固化时间和拉伸强度)必须经过精心设计，以生产一种可以在手术室环境中通过喷雾小批量输送的胶粘剂，同时满足既定的性能要求。2)开发输送装置原型，将粘合剂均匀地喷洒在平面上。将开发一种喷嘴，当连接到注射器输送装置上时，可以预测和可靠地分散粘性液体。3)确定使用喷雾输送系统可以获得足够的粘结强度。新配方将用新的输送装置进行测试，以确定产品在通过新装置输送时性能良好。在该项目的第二阶段，这种可喷雾粘合剂将在体内进行测试，以证明关闭平面组织和防止术后积液的有效性。这项研究项目将包括最终确定产品规格，包括产品配方和递送设备，在公认的预防血清瘤的动物模型中进行有效性测试，以及在人体上进行可行性研究，以向FDA提供数据，以支持上市前批准(PMA)。。浆膜瘤形成是最常见的术后并发症之一，在某些外科手术中发生的比例高达50%。该项目的长期目标是创造一种可喷涂的手术粘合剂，以满足手术对粘合平面组织瓣的坚固、易于使用的粘合剂的需求。这种新型粘合剂将通过消除伤口中的死腔和保持组织处于自然愈合的位置来减少手术后液体的积累。

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.