Laparoscopic surgery offers significant benefits to patients in low-resource settings compared to open surgery such as faster recovery, less pain, and lower infection rate. However, there exist significant barriers to the safe introduction of laparoscopy such as high costs and limited availability of trained staff. Low- and middle-income country (LMIC) hospitals suffer from higher post-surgical infection which might be due to the limited facilities for the sterile reprocessing of laparoscopic instruments. To design a solution to this issue, a detailed understanding of local settings was needed. Therefore, this research applied a context-driven design approach, based on the Roadmap for Design of Surgical Equipment for Safe Surgery Worldwide. Over several design phases, the need for a reprocessing device was established. An analysis of the sterile reprocessing of laparoscopic instruments led to a list of context-specific design requirements. These were translated to a final conceptual design of a laparoscopic instrument cleaner using a waterfall design method. Finally, a usability study of the loading system of the device was conducted with nurses in four Indian hospitals. A root-cause analysis of the usability study showed that the device was not intuitive enough to use for Indian nurses. A redesign of the loading system was made to improve its ease of use. The design process used in this study can be used as an example for designers wanting to address the critical issue of context-specific medical devices worldwide, or more specifically, the sterile supply of surgical instruments in resource-constrained environments.

Background: During minimal access surgery, surgical smoke is produced which can potentially be inhaled by the surgical team, leading to several health risks. This smoke can escape from the abdominal cavity into the operating room due to trocar leakage. The trocars and insufflator that are used during surgery influence gas leakage. Therefore, this study compares particle escape from a valveless (Conmed AirSeal iFS), and a conventional (Karl Storz Endoflator) system. Materials and methods: Using an in vitro model, a conventional and a valveless trocar system were compared. A protocol that simulated various surgical phases was defined to assess the surgical conditions and particle leakage. Insufflation pressures and instrument diameters were varied as these are known to affect gas leakage. Results: The conventional trocar leaked during two distinct phases. Removal of the obturator caused a sudden release of particles. During instrument insertion, an average of 211 (IQR 111) particles per second escaped when using the 5 mm diameter instrument. With the 10 mm instrument, 50 (IQR 13) particles per second were measured. With the conventional trocar, a higher abdominal pressure increased particle leakage. The valveless trocar demonstrated a continuously high particle release during all phases. After the obturator was removed, particle escape increased sharply. Particle escape decreased to 1276 (IQR 580) particles per second for the 5 mm instrument insertion, and 1084 (IQR 630) particles per second for 10 mm instrument insertion. With the valveless trocar system, a higher insufflation pressure lowered particle escape. Conclusions: This study shows that a valveless trocar system releases more particles into the operating room environment than a conventional trocar. During instrument insertion, the leakage through the valveless system is 6 to 20 times higher than the conventional system. With a valveless trocar, leakage decreases with increasing pressure. With both trocar types leakage depends on instrument diameter.

Background: During laparoscopic surgery, CO₂ insufflation gas could leak from the intra-abdominal cavity into the operating theater. Medical staff could therefore be exposed to hazardous substances present in leaked gas. Although previous studies have shown that leakage through trocars is a contributing factor, trocar performance over longer periods remains unclear. This study investigates the influence of prolonged instrument manipulation on gas leakage through trocars. Methods: Twenty-five trocars with diameters ranging from 10 to 15 mm were included in the study. An experimental model was developed to facilitate instrument manipulation in a trocar under loading. The trocar was mounted to a custom airtight container insufflated with CO₂ to a pressure of 15 mmHg, similar to clinical practice. A linear stage was used for prolonged instrument manipulation. At the same time, a fixed load was applied radially to the trocar cannula to mimic the reaction force of the abdominal wall. Gas leakage was measured before, after, and during instrument manipulation. Results: After instrument manipulation, leakage rates per trocar varied between 0.0 and 5.58 L/min. No large differences were found between leakage rates before and after prolonged manipulation in static and dynamic measurements. However, the prolonged instrument manipulation did cause visible damage to two trocars and revealed unintended leakage pathways in others that can be related to production flaws. Conclusion: Prolonged instrument manipulation did not increase gas leakage rates through trocars, despite damage to some individual trocars. Nevertheless, gas leakage through trocars occurs and is caused by different trocar-specific mechanisms and design issues.

Background: Laparoscopy is a minimally-invasive surgical procedure that uses long slender instruments that require much smaller incisions than conventional surgery. This leads to faster recovery times, fewer post-surgical wound infections and shorter hospital stays. For these reasons, laparoscopy could be particularly advantageous to patients in low to middle income countries (LMICs). Unfortunately, sterile processing departments in LMIC hospitals are faced with limited access to equipment and trained staff which poses an obstacle to safe surgical care. The reprocessing of laparoscopic devices requires specialised equipment and training. Therefore, when LMIC hospitals invest in laparoscopy, an update of the standard operating procedure in sterile processing is required. Currently, it is unclear whether LMIC hospitals, that already perform laparoscopy, have managed to introduce updated reprocessing methods that minimally invasive equipment requires. The aim of this study was to identify the laparoscopic sterile reprocessing procedures in rural India and to test the effectiveness of the sterilisation equipment. Methods: We assessed laparoscopic instrument sterilisation capacity in four rural hospitals in different states in India using a mixed-methods approach. As the main form of data collection, we developed a standardised observational checklist based on reprocessing guidelines from several sources. Steam autoclave performance was measured by monitoring the autoclave cycles in two hospitals. Finally, the findings from the checklist data was supported by an interview survey with surgeons and nurses. Results: The checklist data revealed the reprocessing methods the hospitals used in the reprocessing of laparoscopic instruments. It showed that the standard operating procedures had not been updated since the introduction of laparoscopy and the same reprocessing methods for regular surgical instruments were still applied. The interviews confirmed that staff had not received additional training and that they were unaware of the hazardous effects of reprocessing detergents and disinfectants. Conclusion: As laparoscopy is becoming more prevalent in LMICs, updated policy is needed to incorporate minimally invasive instrument reprocessing in medical practitioner and staff training programmes. While reprocessing standards improve, it is essential to develop instruments and reprocessing equipment that is more suitable for resource-constrained rural surgical environments.

This paper presents the static balancing design of a special reconfigurable linkage that can switch between two one-degree-of-freedom (DoF) working configurations. We will show that the studied dual-mode linkage only requires one mechanical spring or one counterweight for completely balancing its gravitational effect in theory at both modes. First, the theoretical models of the spring-based and the counterweight-based designs are derived. The proposed design concepts were then demonstrated by a numerical example and validated by software simulation. Experimental tests on both designs were also performed. The result of this study shows that a reconfigurable mechanism with N working configurations can be completely statically balanced by using less than N passive energy elements.