SBIR Phase II: Development of a Barrier Film to Prevent Post-operative Internal Scarring

SBIR 第二阶段：开发隔离膜以防止术后内部疤痕

• 批准号: 1660209
• 负责人: Erik Robinson
• 金额: $ 74.82万
• 依托单位: Sintact Medical Systems, LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-04-01 至 2020-03-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1660209&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Development; Barrier

This Small Business Innovation Research (SBIR) Phase II Project will continue development of a non-resorbable surgical film which prevents internal tissue-attachment. The proposed device will improve post-surgical outcomes from patients who suffer from internal tissue-attachment triggered by cardiothoracic or neurological surgery. Patients who undergo surgery are at risk for developing unwanted tissue-attachment due to trauma as a result of surgical intervention. This tissue-attachment can lead to severe complications and increase the burden of post-operative care resulting additional expenditures through extended hospital stays, readmissions, and increased morbidity and mortality rates. In addition, undesirable tissue attachment can obstruct the surgical field upon re-operation when necessary. Surgical related tissue-attachment is a problem amongst many surgical procedures in a number of areas. However, cardiothoracic and neurological procedures are often more complicated than gastrointestinal or gynecologic procedures, making any complications more expensive and risky to providers, payers and patients. Additionally, re-operations in cardiac or neuro-spine cases are extremely difficult, which underscore the need for an effective solutions to prevent this malady even more urgent. A product that can effectively prevent undesirable tissue-attachment and provide the surgeon with a clear surgical field and plane of view would be highly desirable in both cardio-thoracic and neurological surgery.The proposed project will conduct additional pre-clinical work leading to a regulatory submission for a cardio-thoracic indication and additional validation within the neurological field. Positive animal studies completed during Phase I & IB efforts revealed the capacity of the Sintact Film? to reduce tissue attachment and provide for a clear field of view upon re-entry or re-operation. Initial Phase II work will examine the feasibility of scaling-up certain manufacturing and production processes resulting in a clinical grade product which will undergo sterility, safety, animal, biocompatibility, and mechanical testing. This testing will be compared directly to a predicate or equivalent approved medical device. Results will need to show equivalency of the Sintact Film? to the predicate device across all testing metrics. Additional Phase II work will enable further validation of the Sintact Film? for neurological indications. A larger definitive neurological study will be completed to address the capability of the Sintact Film? to be deployed effectively in a neurological setting. Positive results from this study will provide a basis for pursuing expanded indications and additional market opportunities. If successful the implications that a non-resorbable product can be an effective countermeasure in these areas would alter the current methodology in the field.

该小型企业创新研究 (SBIR) 第二阶段项目将继续开发一种不可吸收的手术薄膜，以防止内部组织附着。该装置将改善因心胸或神经手术引发的内部组织附着的患者的术后结果。接受手术的患者存在因手术干预造成的创伤而产生不必要的组织附着的风险。这种组织附着可能导致严重的并发症，并增加术后护理的负担，从而导致住院时间延长、再入院以及发病率和死亡率增加等额外支出。此外，必要时再次手术时，不良组织附着可能会阻塞手术区域。手术相关的组织附着是许多领域的许多外科手术中的一个问题。然而，心胸和神经系统手术通常比胃肠道或妇科手术更复杂，这使得任何并发症对提供者、付款人和患者来说都更加昂贵和风险。此外，心脏或神经脊柱病例的再次手术极其困难，这凸显了更加迫切需要有效的解决方案来预防这种疾病。一种能够有效防止不良组织附着并为外科医生提供清晰的手术视野和视野的产品在心胸外科和神经外科手术中都是非常理想的。拟议的项目将进行额外的临床前工作，从而获得监管提交心胸适应证和神经学领域的额外验证。在 I 期和 IB 期工作中完成的积极动物研究揭示了 Sintact Film 的能力？减少组织附着并在重新进入或重新手术时提供清晰的视野。最初的第二阶段工作将检查扩大某些制造和生产工艺的可行性，从而产生临床级产品，该产品将接受无菌、安全、动物、生物相容性和机械测试。该测试将直接与谓词或同等批准的医疗设备进行比较。结果需要显示与 Sintact 薄膜的等效性吗？跨所有测试指标的谓词设备。额外的第二阶段工作将进一步验证 Sintact 薄膜？用于神经系统适应症。将完成一项更大规模的明确神经学研究来解决 Sintact 薄膜的功能？在神经系统环境中有效部署。这项研究的积极结果将为寻求扩大适应症和额外的市场机会提供基础。如果成功，不可吸收产品可以成为这些领域的有效对策，这将改变该领域当前的方法。