Clinical (re)use of modular robotic surgical system: how to ensure sterility

Clinical (re)use of modular robotic surgical system: how to ensure sterility

Berendsen, Jasmijn (TU Delft Mechanical, Maritime and Materials Engineering)

Horeman, T. (mentor)
Dankelman, J. (mentor)

Delft University of Technology

Biomedical Engineering

2018-05-07

The medical device market is continuously innovating to improve the outcome in the treatment of patients. One of these innovations is minimally invasive robot-assisted surgical systems to assist in performing laparoscopic surgical procedures and to allow surgeons to perform the most complex and delicate surgeries with pinpoint precision in very tight spaces in the body.

The sweeping and rapid innovations in surgery can almost universally be seen as an advanced surgical treatment. However, there is a downside. The surgical instruments have become increasingly complex and therefore more and more difficult to clean. The reuse of improperly reprocessed reusable instruments may lead to surgical site infections and spread of diseases. This is an major public health concern, since the consequences of reprocessing failures are severe.

The increasing difficulties of proper cleaning of complex instruments is often due to a lack of knowledge and understanding of the reprocessing process by the manufacturer. As is concluded in the literature review of Berendsen, the manufacturers must stop the downward spiral of developing increasingly impossible reprocessable devices and therefore the unnecessary purchase of expensive new reprocessing machines by hospitals. Berendsen recommended ''Design for Reprocessing'', which focuses on the design of simplified devices containing easy to clean design features which can be disassembled, or prevent hard to clean parts from getting contaminated.

This fundamental aspect has been applied to the design and development of the Portable Laparoscopic Robotic System (PoLaRS) to ensure sterile (re)use in clinical applications. PoLaRS is a light weight, portable tele-surgical system developed for performing extra-luminal procedures with low costs in comparison with existing systems. The newly developed PoLaRS's instruments have a system which may be separated into different parts and are connected with the implementation of a Coupling Mechanism. The Coupling Mechanism is located in between the instrument and the Control Box. It is designed to prevent body fluids reaching the hard to clean Control Box due to blood flow through the instrument lumena towards the Box caused by the intra-abdominal pressure. Furthermore, it must prevent blood reaching the Control Box (manipulator arm) due to blood spattering or contamination from the sterile assistant's hand. Therefore, the complex Control Box does not need to be reprocessed, but only the remaining easy to clean instrument parts. In addition, the Coupling Mechanism must be user-friendly for the sterile assistant and the sterile processing staff.
The Coupling Mechanism design must fulfil these multiple requirements to function accordingly. The critical features, such as the function of the sterile barrier and the use of the Coupling Mechanism, are evaluated to assess the system. Design improvements based on the experiments are implemented in the final Coupling Mechanism prototype.

The final Coupling Mechanism has embodied a frictionless solution by releasing blood that enters the Coupling Mechanism to the outer environment via outflow-openings. This facilitates the transfer of movements from the Control Box to the instrument. The complex hard to clean parts of the PoLaRS are covered by the Coupling Mechanism. The results of the usability experiment regarding the experienced workload and the required time for assembling and dismantling the PoLaRS mock-up version were very promising.

Future research should focus on experiments executed with the complete assembled PoLaRS including the final Coupling Mechanism to substantiate the promising results of the pilot study.

PoLaRS
SATA-RT instrument
Control Box
Coupling Mechanism
robotic surgery
cleanability
detachable
modular

http://resolver.tudelft.nl/uuid:b8663fef-3db9-4492-a0a4-38c425811017

2023-05-01

Student theses

master thesis

© 2018 Jasmijn Berendsen