Clinical Considerations for Flexible Access Surgery

Abstract

The expectation of excellence in health care in modern times continues to be challenged. Government and patients alike continue to demand superior health care with excellent treatment outcomes at minimal expense to their time and convenience. Although surgery is the most definitive treatment option in modern medicine, it can be the most demanding both physically and psychologically. The less invasive the procedure offered the more acceptable it has been shown to be to the patient more often with fewer complications attributed and a faster return to health (1). The positive impact of the minimally invasive concept on the healthcare system has been unfathomable. The domino effect created by the early results from laparoscopic surgery was felt not only across the surgical community but also the medical. Across different specialties, alternative novel therapeutic techniques were devised to overcome problems relating to the large operative procedures which struggled to cross over to the laparoscopic approach. The best example of this is in cardiovascular surgery, where image guided endovascular techniques have overcome the need for many of the once extensive operative procedures including the abdominal aortic aneurysm repair and the coronary bypass procedure. The risks and complications from these operative interventions remain significant and are still performed, though far less frequently than in the past. Selective aneurysms as well as primary coronary events are managed routinely through the endovascular technique with surgery being retained for the complex cases or the non-responders. It seems obvious in hindsight that given the choice of a small 5mm groin incision over a large 30cm open chest or abdominal incision which the public would choose, even with the greater long term benefits sometimes favoring the open approaches. Gastrointestinal endoscopy has the potential to move in the same direction. The use of the endoscope as a surgical tool rather than simply an investigative device has only recently been recognized, promoted through the concept of Natural Orifice Translumenal Endoscopic Surgery (NOTES). The technique aims to provide a cosmetic enhancement to routine surgical procedures by creating the access incision within a natural orifice. The endoscope provides the vision and the biopsy channels in-built are able to guide operative instruments to the target site to enable a therapeutic procedure to be undertaken. However, it would be naïve to believe that in the current state NOTES is anything but a fashionable research technique and far from routine clinical use. However, it’s most superior element, which has the potential to extend the boundaries of surgery aside from all else, is the flexibility of the platform. This thesis provides a detailed investigation into the use of the flexible endoscope as a surgical platform. It defines Flexible Access Surgery (FAS) as an all encompassing surgical technique which utilizes flexible platforms at its heart, describes some novel applications representative as examplars of the technique and explores the significant challenges which would hinder clinical translation. These challenges are described and integrated into two novel enhanced mechatronic flexible access surgical platforms which are further validated and trialed within the pre-clinical in-vivo setting as the future of flexible surgery. The major original contributions of this thesis include the description and definition of the flexible access technique with novel clinical applications. The design, construction and validation of a flexible access box simulator for describing flexible endoscopic navigation within a spatial environment highlighting the challenge this encompasses for many clinicians. The instrumental requirements are explored through the evaluation of the force requirements within the preclinical setting and the instrument refinement both in design and practice that can be adopted to optimize the force delivery particularly when relating to novel flexible platform designs. Finally, the thesis describes the integrated clinical design and validation of two enhanced mechatronic flexible access platforms and describes their clinically driven construction through a series of pre-clinical live in-vivo trials. The evolution of each device is described with performance evaluation and clinical exemplars undertaken. The impact of the results presented within this thesis and the potential for further high impact research is centered on the design and integration of future flexible robotic platforms for minimally invasive surgery. The clinical and mechanical requirements essential for optimal clinical performance will enable designs to be more clinically relevant and ultimately more clinically translatable in the future. Defining these requirements has entailed the use of mapping and sensing the relevant tools which has in turn exposed future potential research avenues to be opened into the perhaps more relevant real time evaluation of the surgical workflow, enabling clinical skills to be more reliably quantified during laparoscopic and endoscopic procedures.