组织容纳系统（TCS）是医疗器械，可在微创腹腔镜手术中摩擦切割过程中使用。TCS不是新设备，但其作为潜在缓解病变在纤维瘤和/或子宫腔镜摩擦切割过程中蔓延的工具备受关注。在接受腹腔镜子宫切除术的女性中，先前未被发现的肉瘤升级的报告之后。建立标准化测试方法和接受标准来评估这些设备的安全性和性能将加快发展，使更多设备受益于患者。作为这项研究的一部分，开发了一系列预临床实验台式试验方法，以评估可能用于动力摩擦切割过程中的TCS的机械和泄漏性能。实验测试被开发来评估TCS的机械完整性，例如拉伸，爆裂，刺穿和穿透强度，以及漏洞完整性，例如TCS的染料和微生物泄漏（都作为代理人来自血液和癌细胞）。此外，为了将机械完整性和泄漏完整性作为组合方法进行评估，对TCS进行了部分穿孔和染料泄漏的评估，以评估由于手术工具造成的部分损伤而导致泄漏的潜力。对来自7种不同TCS的样品进行了临床前台式测试，以评估泄漏和机械性能。TCS的性能在不同品牌之间有很大差异。7种TCS品牌的泄漏压力在26和> 1293 mmHg之间变化。同样，破坏拉力，爆破压力和穿刺力分别在14和80 MPa，2和78 psi，2.5 N和47 N之间变化。 TCS的机械失效和泄漏性能对于均质和复合TCS是不同的。本研究所报道的测试方法可以促进这些设备的开发和监管审查，可以帮助比较设备之间的TCS性能，并提高提供者和患者对改进的组织容纳技术的可访问性。 ©2023。这是一项美国政府工作，不受美国版权保护限制; 可能适用于外国版权保护。

Tissue containment systems (TCS) are medical devices that may be used during morcellation procedures during minimally invasive laparoscopic surgery. TCS are not new devices but their use as a potential mitigation for the spread of occult malignancy during laparoscopic power morcellation of fibroids and/or the uterus has been the subject of interest following reports of upstaging of previously undetected sarcoma in women who underwent a laparoscopic hysterectomy. Development of standardized test methods and acceptance criteria to evaluate the safety and performance of these devices will speed development, allowing for more devices to benefit patients. As a part of this study, a series of preclinical experimental bench test methods were developed to evaluate the mechanical and leakage performance of TCS that may be used in power morcellation procedures. Experimental tests were developed to evaluate mechanical integrity, e.g., tensile, burst, puncture, and penetration strengths for the TCS, and leakage integrity, e.g., dye and microbiological leakage (both acting as surrogates for blood and cancer cells) through the TCS. In addition, to evaluate both mechanical integrity and leakage integrity as a combined methodology, partial puncture and dye leakage was conducted on the TCS to evaluate the potential for leakage due to partial damage caused by surgical tools. Samples from 7 different TCSs were subjected to preclinical bench testing to evaluate leakage and mechanical performance. The performance of the TCSs varied significantly between different brands. The leakage pressure of the TCS varied between 26 and > 1293 mmHg for the 7 TCS brands. Similarly, the tensile force to failure, burst pressure, and puncture force varied between 14 and 80 MPa, 2 and 78 psi, and 2.5 N and 47 N, respectively. The mechanical failure and leakage performance of the TCS were different for homogeneous and composite TCSs. The test methods reported in this study may facilitate the development and regulatory review of these devices, may help compare TCS performance between devices, and increase provider and patient accessibility to improved tissue containment technologies.© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.