Lighting Pelvic Surgeries

This report aims in one hand to demonstrate the carried out iterative process of product development including the chosen framework, decision validation, tests and conclusions. On the other hand it intends to be a contribution for the creation of specific standards for surgical illumination. The premise of this project was the insufficient visualization in the deep pelvis during open surgery. The deep pelvis has a complex anatomy because it includes a great number of organs in a particularly small and curved cavity. Shadows, blood obstruction and procedure limitations are permanent challenges a surgeon must face when operating in this region. The available lighting options do not solve the problem since they provide no adequate light focus and are not designer to manoeuvre within space limitations. Other solutions in the market as specific small illuminators are considered to expensive or uncomfortable to use. Chapter 1 introduces the approach undertaken to the claimed problem. This analysis is structured in four main aspects that surround the field of design concerns in order to create a framework around which to work. The context topic is related to the experience of getting in touch with the medical subject for the first time. It is a complex field of specific scientific knowledge and strict rules which are fundamental to understand and be familiar with, in order to properly locate the designed product. Light is the particular domain of this assignment. A study of basic knowledge about light is introduced followed by the characterization of medical lighting. This study revealed its importance not only for the choice of an adequate light technology but also for the fact that the lessons learned in this chapter’s topic were decisive for the development of the final design solution. The understanding of the behaviour of light and the working principle of optical fibres allowed a creative move towards a new product, based in a simple theory. In addition the light requirements for medical purpose were found to have few specialized standards. This project started up an inventory of important measurements to contribute for the surgical lighting knowledge necessary to develop good products. An overview of the existing products available in market made possible to understand that mostly optical fibre and LED light sources have potential for lighting a surgical scene. This is basically due to their size, minimal heat emission and light quality. Both technology and associated products have advantages and drawbacks that were considered for the development of this product. The topic about environment makes a call of attention to the problems related with the lifecycle of current products, such as plastic disposables, and their respective waste streams in particular the demanding biomedical waste management. An overview of the available options for the today’s products disposal is made with the respective characterization. Solutions can and must be found in strategies of shared responsibility and contribution that start with designers, in collaboration with a network of professional, and end in the final user. The design of a new product must take in account this prior knowledge in order to perform better in the future. Throughout the complete chapter 1 several cross references are made to the appendix report. This document is, especially for the initial approach, an essential complement since it contains all the support information for the learning process in an extensive guide of in depth information. In chapter 2 the previous topics are synthesized in three different design opportunities which are related with the scope of the project. These were important in order to establish and communicate a stepwise decision process with the participation of the user. Additional ideas concerning the functionality of different products are reported, demonstrating that the operating room has space for several design improvements, from the logistic point of view to a technical product level. Chapter 3 reports the idea phase where the chosen design direction was further explored with an additional study of patents and idea generation. The sketch results lead to the development of the two more promising concepts that have integrative functions and don’t imply the replacement of surgical tools but rather function together with them. The user is once again involved for a discussion of values for each solution. The choices made in this chapter are based in the main interest of the user. Performance/usability, commercial interest and light adequacy are the three main product characteristics that allow a good comparison between the presented options. Since there are no specific standards to compare the final choice with, a list of requirements of qualitative character is formulated. This list introduces for first time the most relevant evaluation factors used in both, development decisions and later assessment of the product. The factors are: (1) functionality – from ergonomics point of view: efficiency, safety and comfort, – (2) cost and (3) environment. The Extender add on is a concept dedicated to the perineal incision made in a Abdomino-Perineal approach where a rectal self retaining retractor is permanently used. The concept consists of a cordless, user independent device that integrates the illuminating feature with the elongation of the retractor’s performance. Chapter 4 initiates the product development in detail. From the previous list of requirements a quantitative criteria is created that relates each qualitative requirement to specific knowledge gathered all through the analysis phase. In this way the product development finds fundament in required tangible features that allow the progress from a rough concept proposal to a final design. Choices are made relative to material, light and power sources and in the end, construction considerations are made defining the final product. This phase required the construction of small models to exemplify the Total Internal Reflection principle, measurements of light and force in context. The main challenges faced during this stage were the dimensioning of the product, the choice of a power source and its sterile use. A battery solution is suggested for current application but an advice is kept for the future application of better solutions, not yet available in market, as the free form Lithium polymer batteries. The product, Indirect, is designed according to manufacturing and to use limitations and is later modelled in Solid Works. Chapter 5 is dedicated to the evaluation of the designed product. This phase is meant firstly to verify that the intended use is accepted by the user. A product prototype is also built for tests related with the involved electronics addressing in particular the heat management of the light source. Finally chapter 6 makes the overview of the project with the most relevant conclusions and recommendations of different nature. The further development of the product is advised, namely with more accurate, perhaps official, tests and also additional research, as the lifecycle analysis of the device for a proper performance evaluation. This report encloses the complete undertaken process, from a first approach to the comprehensive results of a design project. The results are considered fruitful. This project was always faced as a part of a larger project that includes a complete inventory of ideas to improve the OR and the surgeon’s profession. At times where high technology is given the highlights it is most important not to forget the backstage design which still moves the people and the world with well designed usable products.