Center for Devices and Radiological Health, Food & Drug Administration, Silver Spring, MD, USA.
Sci Rep. 2023 Mar 29;13(1):5104. doi: 10.1038/s41598-023-31847-7.
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.
组织封闭系统（Tissue containment systems，TCS）是一种医疗器械，可能在微创腹腔镜手术的旋切术中使用。TCS 并不是新设备，但在报道腹腔镜子宫切除术患者隐匿性恶性肿瘤分期升高后，它们作为一种减少腹腔镜动力旋切子宫肌瘤和/或子宫时隐匿性恶性肿瘤播散的潜在缓解方法，引起了人们的关注。开发标准化测试方法和验收标准来评估这些设备的安全性和性能将加速设备的开发，使更多的设备使患者受益。作为这项研究的一部分，开发了一系列临床前实验台架测试方法，以评估可能用于动力旋切术的 TCS 的机械和泄漏性能。开发了实验测试来评估 TCS 的机械完整性，例如拉伸、爆裂、穿刺和穿透强度，以及泄漏完整性，例如通过 TCS 的染料和微生物泄漏（两者都可作为血液和癌细胞的替代品）。此外，为了评估机械完整性和泄漏完整性作为一种综合方法，对 TCS 进行了部分穿刺和染料泄漏测试，以评估由于手术工具造成的部分损坏导致泄漏的可能性。对 7 种不同 TCS 的样本进行了临床前台架测试，以评估泄漏和机械性能。不同品牌的 TCS 性能差异很大。7 种 TCS 品牌的 TCS 泄漏压力在 26 至>1293mmHg 之间。同样，拉伸破坏力、爆裂压力和穿刺力分别在 14 至 80MPa、2 至 78psi 和 2.5N 至 47N 之间变化。同质和复合 TCS 的 TCS 机械故障和泄漏性能不同。本研究报告的测试方法可能有助于这些设备的开发和监管审查，有助于比较设备之间的 TCS 性能，并增加提供者和患者获得改进的组织封闭技术的机会。
