Recently, the world population has crossed 8 million people and it is estimated that out of every three persons two cannot afford surgery (Meara et al., 2015a). Surgery is the primary treatment for one-third of the diseases (Quene et al., 2022), but since 6 percent of all procedures are performed in the poorest countries, where more than one third of the world’s population lives (Meara et al., 2015). This creates a need for accessible surgery.
Laparoscopic surgery is a commonly used surgery technique to replace open surgery on the abdominal region. Research shows that this method gas multiple benefits over conventional laparoscopy , including: lower infection rates, shorter hospital stay, faster return to normal activity, improved cosmetics, reduced postoperative pain and medication use (2013; Chao et al., 2016; Epstein et al., 2013; Kalser, 1993; Murphy et al., 1992; Solomon Bekele & Hagos Biluts, 2012; Straub et al., 2011; Udwadia, 2001; Zadey et al., 2023). However, in low resource countries, without advanced technology like robot arms, laparoscopes are hold by healthcare assistants. A field study showed that these healthcare assistants need to hold and manoeuvre the laparoscope in the abdominal without support. Resulting in fatigue that hinders the movement of the laparoscopic instruments and vision on the operation area. Therefore, the goal of this study is to
‘Design a product to improve the ergonomics for healthcare personnel that holds a laparoscope during surgery in low resource settings’.
To provide a thorough solution for this design goal incorporating the local context, a framework is chosen. The first four steps follow a Roadmap for safe (Oosting, 2019), covering: 0) identify need 1) understanding of the local context, 2) determine design requirements, 3) concept development and validation. Two following steps are added based on (Webb et al., 2022) 4) refine through design to manufacture 5) clinical validation. In this study, the last step is modified by a phantom test.
Step 0 concludes the reason for this study, the ergonomics of the healthcare assistants needs to be improved. Followed by gaining contextual insight though field studies in India. This results in preliminary design requirements that will updated during the study. This field study showed that it is desirable to have a holder that supports the laparoscope during surgery. The ideal location is below the RAIS abdominal ring (top of the incision) and above the laparoscopic instruments (placed at the bottom of the incision) and connected to the RAIS device. A second field study for Phase 3 at a WHO conference and rural hospitals in India is used to iterate and validate the concepts. In this step, an ideal design is made that form fits easily on the abdominal ring of the RAIS device and that provides a stable support for the laparoscope. In the fourth step, this design is refined for manufacturing. A medical grade material selection is performed which resulted into AISI 316L stainless steel that is able to be manipulated by cold forming and welding if needed. With this material and production method in mind, the holder is designed according to ISO 7153-1 to make sure the holder remains hygienic. An Indian manufacturer can produce the holder for around 200 Indian Rupees, meaning just above two euro, which is within the requirement of 5 Euros per piece.
A phantom test with an Indian surgeon is conducted to test the performance of the holder. The vertical force on the holder during surgery is measured and used for a final FEM analysis. The FEM analysis shows a stress well below the fatigue stress for 1e7 cycles. The phantom test concluded that the holder is suitable to support the laparoscope reducing the stress on the laparoscopic assistant. Secondly, the holder is suitable for implementation in low resource settings.
To conclude, the designed holder improves the ergonomics for the healthcare assistants during operation, its price to produce is well below 5 Euros and is therefore suitable for low resource settings. Initially it was desired to make a holder that could fix the laparoscope by a surgeon during single surgery, this demand was deemed unnecessary because the field study showed that enough personnel was available. However, introducing this option could also improve the ergonomics, but at the cost of complexity.