SBIR Phase I: Bioresorbable Polyurethane Scaffold Materials for Regenerative Applications in Advanced Wound Healing

这个小型企业创新研究(SBIR)第一阶段项目旨在开发一种可生物吸收的支架材料，用于高级伤口愈合，如糖尿病溃疡和压疮。具体目标是开发一种具有双功能的高度多孔的生物材料，即用作真空疗法(负压创伤疗法)治疗的伤口的敷料材料，同时也用作组织再生的支架。研究表明，接受NPWT治疗的患者必须经历几次痛苦的敷料更换，因为目前的敷料中会出现组织内生。此外，换药过程中的反复损伤进一步推迟了愈合。该项目将通过开发一种可吸收的敷料支架材料来满足这一重要的未得到满足的需求，这种材料将允许在NPWT期间植入，然后以所需的速度降解，使正常组织能够在伤口内再生和组织起来。这项技术满足了高级伤口愈合方面临床上尚未满足的主要需求，并将显著降低治疗成本，同时提高这些虚弱伤口患者的生活质量。这项研究的更广泛影响是在普通外科、心胸外科和整形外科的组织再生和修复、创伤、运动医学和骨折愈合的各种应用中。这项新的支架技术将在使用工业发泡和热网技术的大规模泡沫制造方法的框架内开发。这还将降低生物材料的成本，并对美国广泛的临床应用领域的医疗支出产生重大影响。

This Small Business Innovation Research (SBIR) Phase I project aims to develop a bioresorbable scaffold material for applications in advanced wound healing, i.e., diabetic ulcers and pressure sores. The specific goal is to develop a highly porous biomaterial that is bifunctional, i.e., used as a dressing material for wounds treated with vacuum therapy (Negative Pressure Wound Therapy-NPWT), and also serve as a scaffold for tissue regeneration. Research shows that patients treated with NPWT have to undergo several painful dressing changes due to the tissue ingrowth that occurs into current dressings. Further, this repeated injury during dressing changes further delays healing. The project will address this important unmet need by developing a resorbable dressing-scaffold material that will allow ingrowth during NPWT, and then degrade at a desired rate to allow normal tissue to be regenerated and organized within the wounds. The technology addresses major clinical unmet needs in advanced wound healing and will produce significant reductions in treatment costs while improving the quality of life for patients who suffer from these debilitating wounds.The broader impacts of this research are in a variety of applications in tissue regeneration and repair for general, cardiothoracic, and plastic surgery; trauma, sportsmedicine, and fracture healing. This novel scaffold technology will be developed within the framework of large scale foam manufacturing methods using industrial foaming and thermal reticulation techniques. This will also reduce the cost of the biomaterial and substantially impact healthcare spending across a broad range of clinical application areas in the US.