In Vitro Leakage Testing of Tissue Containment Bags When Subjected to Power Morcellation Forces

Herman, Alexander; Duraiswamy, Nandini; Nandy, Poulomi; Myers, Matthew R.; Price, Veronica; Gibeily, George; Hariharan, Prasanna

doi:10.1016/j.jmig.2019.05.006

Cited by 3 publications

(12 citation statements)

References 17 publications

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“…The acceptance criteria tend to be device and material speci c and could depend on several factors such as device design, indications for use, choice of comparator device, etc. However, it would be bene cial for the manufacturers to derive appropriate device safety factors [45] by comparing the device's test-to-failure metrics obtained after bench testing with clinically relevant forces encountered by the TCS material during actual surgical procedures. Previous studies have used force sensors to measure the force imparted by the clinicians on the surgical tools during medical procedures.…”

Section: Discussionmentioning

confidence: 99%

“…9) shows that the polymer side was either very thin or completely missing at some locations. Additional details about the SEM data on different TCSs are presented in Herman et al [45].…”

Section: Physical Characteristics Evaluationmentioning

confidence: 99%

“…Label Material Leakage at 2 psi [40] Leakage pressure (psi) [45] TC Dye Penetration Testing after Partial Puncture…”

Section: Tablementioning

confidence: 99%

“…The TCS specimen was then exposed to a pressure of 2 psi for 1 minute. Although, the insu ation pressure during power morcellation can be up to 0.5 psi, the net instantaneous pressure experienced during the procedure when power morcellation forces are included is of the same order as 2 psi [45].…”

Section: Dye Penetration Testing After Partial Puncturementioning

confidence: 99%

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Evaluating the Performance of Tissue Containment Systems: Mechanical and Leakage Integrity Testing Considerations

Herman

Duraiswamy

Nandy

et al. 2022

Preprint

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Background: 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. Methods: 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. Results: The performance of the TCSs varied significantly between different brands. The leakage pressure of the TCS varied between 26 mmHg and >1293 mmHg for the 7 TCS brands. Similarly, the tensile force to failure, burst pressure, and puncture force varied between 14 MPa and 80 MPa, 2.5 and 78 psi, and 2.5 N and 45 N, respectively. The mechanical failure and leakage performance of the TCS were different for homogeneous and composite TCSs. Conclusions: Test methods have been developed to evaluate the mechanical and leakage performance of TCS. These test methods 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.

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Section: Discussionmentioning

confidence: 99%

“…9) shows that the polymer side was either very thin or completely missing at some locations. Additional details about the SEM data on different TCSs are presented in Herman et al [45].…”

Section: Physical Characteristics Evaluationmentioning

confidence: 99%

“…Label Material Leakage at 2 psi [40] Leakage pressure (psi) [45] TC Dye Penetration Testing after Partial Puncture…”

Section: Tablementioning

confidence: 99%

Section: Dye Penetration Testing After Partial Puncturementioning

confidence: 99%

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Evaluating the Performance of Tissue Containment Systems: Mechanical and Leakage Integrity Testing Considerations

Herman

Duraiswamy

Nandy

et al. 2022

Preprint

Self Cite

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“…5 ). For procedural details on dye penetration testing, please see Herman et al 45 . The sensitivity of the dye test method was validated using microbiological penetration testing.…”

Section: Methodsmentioning

confidence: 99%

Mechanical and leakage integrity testing considerations for evaluating the performance of tissue containment systems

Herman

Duraiswamy

Nandy

et al. 2023

Sci Rep

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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.

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Risk of leakage with a new detachable multi-hard-port containment system for power morcellation during gynecologic laparoscopy: An in vitro study

Zhao,

Wang,

Ling

et al. 2023

BMC Surg

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Background Laparoscopic surgery has been a milestone for minimally invasive surgeries. But safe removal of large uterine tissue is a challenge for minimally invasive procedures, and there still exists concern about the dissemination of benign or occult malignant uterine tissue during the use of the morcellator. Different tissue containment systems have been used in laparoscopic power morcellation. However, a risk of leakage still exists in clinical practice. In this study, we aimed to evaluate leakage and tissue dissemination associated with a new detachable multi-hard-port containment system for tissue removal during laparoscopic myomectomy morcellation. Methods Beef tongue specimens were stained with methylene blue solution and morcellated in a plastic trainer box under laparoscopic guidance. The morcellation test in vitro conditions comprised two different containment systems to simulate laparoscopic power morcellation, specifically a polyurethane bag with two pipes (control group) and a detachable multi-hard-port containment system (experimental group). Insufflation pressure was set at 14 mmHg. Three methods are used to detect the leakage The procedure times were recorded. Thirty trials were performed using a multi-port approach and the two tissue containment systems. Results The leakage rate was 0.03% (n = 30) for the experimental group and 26.6% (n = 30) for the control group (p < 0.005). Morcellation time was significantly shorter in the experimental group than in the control group (p < 0.001). Median bag introduction time was shorter in the experimental group than in the control group; however, removal time differences were not significant. Conclusions This study quantified the low leakage rate during morcellation and the improved convenience of operation provided by a new tissue containment system.

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In Vitro Leakage Testing of Tissue Containment Bags When Subjected to Power Morcellation Forces

Cited by 3 publications

References 17 publications

Evaluating the Performance of Tissue Containment Systems: Mechanical and Leakage Integrity Testing Considerations

Evaluating the Performance of Tissue Containment Systems: Mechanical and Leakage Integrity Testing Considerations

Mechanical and leakage integrity testing considerations for evaluating the performance of tissue containment systems

Risk of leakage with a new detachable multi-hard-port containment system for power morcellation during gynecologic laparoscopy: An in vitro study

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