E.B. van der Houwen

Animal models for tracheal research.

Tracheal research covers two main areas of interest: tracheal reconstruction and tracheal fixation. Tracheal reconstructions are aimed at rearranging or replacing parts of the tracheal tissue using implantation and transplantation techniques. The indications for tracheal reconstruction are numerous: obstructing tracheal tumors, trauma, post-intubation tissue reactions, etc. Although in the past years much progress has been made, none of the new developed techniques have resulted in clinical application at large scale. Tissue engineering is believed to be the technique to provide a solution for reconstruction of tracheal defects. Although developing functional tracheal tissue from different cultured cell types is still a challenge. Tracheal fixation research is relatively new in the field and concentrates on solving fixation-related problems for laryngectomized patients. In prosthetic voice rehabilitation tracheo-esophageal silicon rubber speech valves and tracheostoma valves are used. This is often accompanied by many complications. The animal models used for tracheal research vary widely and in most publications proper scientific arguments for animal selection are never mentioned. It showed that the choice on animal models is a multi-factorial process in which non-scientific arguments tend to play a key role. The aim of this study is to provide biomaterials scientists with information about tracheal research and the animal models used.

Difficulties in the fixation of prostheses for voice rehabilitation after laryngectomy

In most patients with advanced or recurrent laryngeal or hypopharyngeal cancer, total laryngectomy is indicated. This means the loss of three main functions: phonation; respiration; and the prevention of aspiration during deglutition. Laryngectomy patients have various options to restore phonation: an oesophageal voice; an electrolaryngeal voice; or a tracheo-oesophageal voice. In the last case a silicone rubber shunt valve is placed in the tracheo-oesophageal wall and phonation is generated when exhaled air is forced through the oesophagus and neopharynx. This method is widely applied in Western Europe. In this paper we review the literature on fixation problems with shunt valves, tracheostoma valves and heat and moisture exchange (HME) filters. Tracheo-oesophageal speech without a valve is not considered. Despite 22 years of experience with the implantation of tracheo-esophageal shunt valves and many improvements in the design, problems still remain, such as biofilm formation with subsequent leakage through the valve, the need for frequent and inconvenient replacements, fistula enlargement leading to leakage around the device and reduced fixation, and infections. The high cost of shunt valves is a drawback to their use worldwide. To enable hands-free speech, different types of tracheostoma valve have been developed. These valves are fixed to the skin or to the tracheostoma by means of an intra-tracheal device. An HME filter is used to protect the airway and maintain physiological balance. Such devices are only suitable for a selected group of patients as fixation to the skin or trachea can be a major problem. Speaking and coughing cause pressure increases, which often result in mucous leakage and disconnection of the valve and/or HME filter. Recommendations are made for future improvements in fixation techniques.

Does the patch fit the stoma? A study on peristoma geometry and patch use in laryngectomized patients

Clin. Otolaryngol. 2011, 36, 235–241

Functional buckling behavior of silicone rubber shells for biomedical use

BACKGROUND The use of soft elastic biomaterials in medical devices enables substantial function integration. The consequent increased simplification in design can improve reliability at a lower cost in comparison to traditional (hard) biomaterials. Functional bi-stable buckling is one of the many new mechanisms made possible by soft materials. The buckling behavior of shells, however, is typically described from a structural failure point of view: the collapse of arches or rupture of steam vessels, for example. There is little or no literature about the functional elastic buckling of small-sized silicone rubber shells, and it is unknown whether or not theory can predict their behavior. Is functional buckling possible within the scale, material and pressure normally associated with physiological applications? An automatic speech valve is used as an example application. METHOD OF APPROACH Silicone rubber spherical shells (diameter 30mm) with hinged and double-hinged boundaries were subjected to air pressure loading. Twelve different geometrical configurations were tested for buckling and reverse buckling pressures. Data were compared with the theory. RESULTS Buckling pressure increases linearly with shell thickness and shell height. Reverse buckling shows these same relations, with pressures always below normal buckling pressure. Secondary hinges change normal/reverse buckling pressure ratios and promote symmetrical buckling. All tested configurations buckled within or closely around physiological pressures. CONCLUSIONS Functional bi-stable buckling of silicone rubber shells is possible with adjustable properties in the physiological pressure range. Results can be predicted using the proposed relations and equations.

In vitro evaluation of the iValve: a novel hands-free speech valve.

Objectives: We performed in vitro evaluation of a novel, disposable, automatic hands-free tracheostoma speech valve for laryngectomy patients based upon the principle of inhalation. The commercially available automatic speech valves close upon strong exhalation and open again when the pressure drops. This method makes long sentences or pauses difficult. The novel iValve is designed to allow almost natural speech, with mid-sentence pausing and whispering. Methods: The inhalation closing flows and exhalation opening pressures of 6 iValve prototype versions at different settings were compared with physiological values. The airflow resistance at inhalation was compared to physiological values and to commercial valve values. Results: The iValve prototypes showed flow and pressure ranges in concordance with the physiological values in the literature. The airflow resistance in the breathing mode was within the physiological airflow resistance range, yet above the values from the two commercial valves. The resistance in the speaking mode was above the physiological airflow resistance range. Conclusions: In vitro tests show that the iValve versions can be selected and adjusted to operate within the physiological range. The airflow resistance in the breathing mode is good. In speaking mode, inhalation should, and can, be decreased. The iValve should offer the patient a more intuitively useable alternative with more dynamic speech. Its low cost allows disposability and wider use.

Redesign of Indonesian-made osteosynthesis plates to enhance their mechanical behavior

Mechanical properties determined by fatigue strength, ductility, and toughness are important measures for osteosynthesis plates in order to tolerate some load-bearing situations caused by muscle contractions and weight-bearing effects. Previous study indicated that Indonesian-made plates showed lower mechanical strength compared to the European AO standard plate. High stress under load-bearing situations often starts from surface of the plate; we therefore refined the grain size of the surface by using shot peening and surface mechanical attrition treatment (SMAT). Single cycle bending tests showed that shot-peened and SMAT-treated plates had significantly higher load limit and bending stress compared to the original plates (p<0.05). Weibull analysis confirmed the improvement of proportional load limit of SMAT-treated plates. Fatigue limit also increased upon shot-peening and SMAT treatment (improvement ratio 18% and 27%, respectively). Significant improvement ratio of fatigue tests can be observed in SMAT-treated plates compared to the untreated and shot-peened plates. Fatigue performance demonstrated equivalent results between SMAT-treated and standard plate. These designated that mechanical properties of Indonesian-made plates can be improved upon SMAT treatment leading to significant enhancement of mechanical strength thus is comparable to the standard plate. Our findings highlight the benefits of SMAT treatment to improve mechanical strength of Indonesian-made osteosynthesis plates.

Mechanical properties of Indonesian-made narrow dynamic compression plate.

Osteosynthesis plates are clinically used to fixate and position a fractured bone. They should have the ability to withstand cyclic loads produced by muscle contractions and total body weight. The very high demand for osteosynthesis plates in developing countries in general and in Indonesia in particular necessitates the utilisation of local products. In this paper, we investigated the mechanical properties, i.e. proportional limit and fatigue strength of Indonesian-made Narrow Dynamic Compression Plates (Narrow DCP) as one of the most frequently used osteosynthesis plates, in comparison to the European AO standard plate, and its relationship to geometry, micro structural features and surface defects of the plates. All Indonesian-made plates appeared to be weaker than the standard Narrow DCP because they consistently failed at lower stresses. Surface defects did not play a major role in this, although the polishing of the Indonesian Narrow DCP was found to be poor. The standard plate showed indications of cold deformation from the production process in contrast to the Indonesian plates, which might be the first reason for the differences in strength. This is confirmed by hardness measurements. A second reason could be the use of an inferior version of stainless steel. The Indonesian plates showed lower mechanical behaviour compared to the AO-plates. These findings could initiate the development of improved Indonesian manufactured DCP-plates with properties comparable to commonly used plates, such as the standard European AO-plates.

Poetry as a cross-cultural analysis and sensitizing tool in design

The overall trend toward globalization in design, greatly enhanced by digital technologies, has raised issues and challenges on how to preserve the cultural differences and values of different societies. There is a tendency to lose touch with local cultural values when designing artefacts for global use, and social nuances and traditions risk to be flattened or stereotyped in the pursuit of developing new technologies and products for the global society. Attempts to reduce the tension between the global and the local in design can be seen in the development of standards and guidelines for cross-cultural design, that are mostly focused on (online) user interface design. However, when moving from preferences, metaphors, appearance, and navigation toward cultural models of interaction and physical design, new methodologies and tools for cross-cultural design are needed. This paper describes a poetry-inspired design method for cross-cultural sharing within the design process. The approach uses poetry to sensitize the designer to the subtleties and diversity of a (new or known) culture so that the design can be given new aesthetic and cultural significance. The methodology is exemplified by actual design cases developed within the course “Cultural Sensitivity” of the Master’s Degree Program in Industrial Design at Eindhoven University of Technology, where poetry was used for uncovering underlying or implicit assumptions, intercultural differences and similarities, as well as for general sensitization of young designers.

In vivo test of a new hands-free tracheostoma inhalation valve, a randomised crossover study

*Department of Otorhinolaryngology/Head & Neck Surgery, University of Groningen, University Medical Center Groningen, Groningen, DQI group, Department of Industrial Design, Eindhoven University of Technology, Eindhoven, Department of Biomedical Engineering, University of Groningen, UniversityMedical Center Groningen, Groningen, and Faculty of Engineering Technology, University of Twente, Enschede, the Netherlands

The iValve Hands-Free Speech Valve for Laryngectomized Patients. In Vitro Test of a Novel Device of Revolutionary Design

Background. Speech valves help restore speech after surgical removal of the larynx (laryngectomy). Laryngectomized Patients breathe through an artificial opening (tracheostoma) in the neck. A shunt valve is routinely inserted between oesophagus and trachea to restore speech. At closure of the stoma with a finger, exhaled air is rerouted into the oesophagus, which will vibrate and form the new voice. Manual closure of the stoma attracts attention, requires one free hand and is unhygienic. Therefore automatic, hands-free speech valves are preferred. Present valves automatically close upon strong exhalation and open again when the pressure drops. This method wastes valuable air during closure and pressure should be maintained during speech, making long sentences or pauses impossible. The new iValve closes at strong inhalation. In speech mode, inhalation mid sentence is now made possible. The patient can speak almost as natural, pausing and whispering at will. The iValve automatic inhalation valve is a full silicone rubber, hands-free speech valve. The switching mechanism consists of a silicone rubber bi-stable valve shell. A prototype was tested in vitro.