Five billion people do not have access to safe surgery, two billion have no access at all, and three billion have access to some kind of surgery, but it is not really safe. Lack of surgery and also poor surgical conditions are neglected global health problems affecting the world’s poorest people. In LMICs (Lower, Middle-Income Countries), operative mortality is high (5–10%), with the majority related to infections, anaesthesia complications, and haemorrhage.
It has been shown that, even in low-resource settings, MIS (Minimally Invasive Surgery) would provide many advantages over open surgery, such as decreased risk of infection, decreased blood loss, reduced postoperative pain, improved bed utilization, shorter hospital stay and rapid return to work. These advantages are even more important in low-resource settings where sanitary conditions are poor, blood banks not available and distances to hospitals are large.
Compared to open procedures, the MIS procedure implies many limitations for the surgeon. Long instruments are inserted through a small incision, resulting in limited movement possibilities, and in scaling and mirroring of movements. An endoscope (camera) is inserted presenting a 2D image on the screen. Due to misalignment of the natural line of sight with the camera orientation, misorientation can occur, limiting the ease of manipulation of the instruments. To improve tissue manipulation capabilities, better tip/tissue alignment due to a steering mechanism between tip and shaft is needed as found in e.g. robotic surgery; however, it is not feasible to use complex and expensive robotic master-slave systems in hospitals in LMICs.
We propose to develop a surgical equipment system which will allow minimally invasive surgery without the need for a sterile operating room and will have lesser dependence on operator skills. We will use a human-centric design approach and co-creation involving clinicians, designers, entrepreneurs and engineers to develop easy-to-manufacture, easy-to-use and easy-to-clean instrument. Prototype testing will be done together with clinical groups in South Asia / Africa, (new) spin-off companies and surgical device certification experts. After benchtop/cadaver testing, the developed instruments will be ready for pilot clinical testing.
The project plan would look like this:
- Year One:
Quarter 1: Study of various laparoscopic procedures and tools for abdominal surgeries.
Quarter 2: Immersion in Operating Rooms of LMIC (India/Nigeria/Sierra Leone/Nepal)
Quarter 3: Review paper submission on the gaps in Minimally Invasive Surgery in Operating Rooms of LMIC
Quarter 4: Development of specifications of the tool to be developed as a part the PhD program
- Year Two:
First half of Year two: In-silico design of mechanical aspect of the laparoscopic equipment
Second half of Year two: Material selection and 3D printing of forms of the equipment
- Year Three:
Quarter 1: Validation of the novel equipment with surgeons and other stakeholders
Quarter 2: Improvement of the tool by incorporation of feedback
Second half of Year three: Cadaver / Bench top study of the tool and developing a manuscript of the results. Application for a patent for the novel tool.
- Year Four:
Quarter 1: Submission of the manuscript for publication; Poster presentation in a conference for minimally invasive surgery. Planning an animal / first-in-man trial for the tool.
Quarter 2: Initiation of the clinical trial process and health technology assessment for the tool.