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İnan Güler - One of the best experts on this subject based on the ideXlab platform.

Sabri Koçer - One of the best experts on this subject based on the ideXlab platform.

Gerard M. Lyons - One of the best experts on this subject based on the ideXlab platform.

  • the application of a use case task based approach in the development of software for a portable Neuromuscular Stimulator device
    Medical Engineering & Physics, 2007
    Co-Authors: K. Furey, Richard Conway, Derek T Okeeffe, Gerard M. Lyons
    Abstract:

    This paper describes the use of a use case/task based method in the development of a portable Neuromuscular Stimulator device. The developed unit allows a variety of stimulus delivery algorithms to be incorporated dependent on the patient's requirements. The developed system consists of a Stimulator unit, Stimulator firmware, external sensors, a programmer unit, two stimulation channels and electrodes. A clinician specifies a suitable algorithm for a particular patient and then selects the relevant stimulus parameters for that algorithm using the programmer unit. The Stimulator unit's architecture supports the addition of future algorithms. The device was developed in accordance with the European Medical Devices Directive 93/42/EEC resulting in the need for a well-defined development lifecycle during the design and development of the Neuromuscular Stimulator. This development lifecycle must place emphasis on the need to identify potential hazards. Therefore, the adoption of a use case/task driven approach as one of the strategies in eliciting the requirements, both functional and non-functional and specification stages of the development lifecycle resulted in a more rigid hazard/risk analysis leading ultimately to a more robust final system. A comprehensive review of the literature has revealed that use cases have been in use in other contexts but not so in a biomedical context. Therefore, this is a novel strategy to the development of a device in this field. A brief background on the historical development of drop foot Stimulators shall be presented thereby displaying the benefits of the programmability feature of our Stimulator.

  • The application of a use case/task based approach in the development of software for a portable Neuromuscular Stimulator device.
    Medical engineering & physics, 2006
    Co-Authors: K. Furey, Richard Conway, Derek T. O’keeffe, Gerard M. Lyons
    Abstract:

    This paper describes the use of a use case/task based method in the development of a portable Neuromuscular Stimulator device. The developed unit allows a variety of stimulus delivery algorithms to be incorporated dependent on the patient's requirements. The developed system consists of a Stimulator unit, Stimulator firmware, external sensors, a programmer unit, two stimulation channels and electrodes. A clinician specifies a suitable algorithm for a particular patient and then selects the relevant stimulus parameters for that algorithm using the programmer unit. The Stimulator unit's architecture supports the addition of future algorithms. The device was developed in accordance with the European Medical Devices Directive 93/42/EEC resulting in the need for a well-defined development lifecycle during the design and development of the Neuromuscular Stimulator. This development lifecycle must place emphasis on the need to identify potential hazards. Therefore, the adoption of a use case/task driven approach as one of the strategies in eliciting the requirements, both functional and non-functional and specification stages of the development lifecycle resulted in a more rigid hazard/risk analysis leading ultimately to a more robust final system. A comprehensive review of the literature has revealed that use cases have been in use in other contexts but not so in a biomedical context. Therefore, this is a novel strategy to the development of a device in this field. A brief background on the historical development of drop foot Stimulators shall be presented thereby displaying the benefits of the programmability feature of our Stimulator.

M. Rahmi Canal - One of the best experts on this subject based on the ideXlab platform.

F. Penninckx - One of the best experts on this subject based on the ideXlab platform.

  • Fecal incontinence: Indications for repairing the anal sphincter
    World Journal of Surgery, 1992
    Co-Authors: F. Penninckx
    Abstract:

    Incontinent patients should be comprehensively investigated by objective tests, especially manometry, continence tests, and electromyography. Manometry can be used to predict the functional outcome and to calibrate the sphincter repair. Pure anatomical defects of the anal and pelvic musculature deserve surgical correction with or without overlapping the muscle ends. If the repair is delayed it should be done after a 3 month interval. A protective colostomy has to be performed in complex cases and in cases with septic complications. Before closing the colostomy, the ano-rectal function should be assessed. Acceptable continence can be restored in the majority of the patients, the outcome depending on the extent of local defects and the severity of concomitant pelvic floor neuropathy. Skeletal muscle transposition remains an esoteric approach to be used only in selected patients; the implantation of a Neuromuscular Stimulator seems to be warranted. In the presence of important functional deficits, sphincter repair may create a situation where additional conservative measures become more effective. A post-anal repair may be considered 3–12 months after rectopexy or sphincter repair. Incontinence based on pure functional defects is initially treated conservatively. A post-anal repair may improve the situation in two thirds of the patients but fails to help those who need it most. Failure seems to be related to a continuing neuropathic process. A peri-anal prosthetic band implant may be a valuable alternative in such patients. A sigmoidostomy is a measure of last resort. The prevention of fecal incontinence is most important and concerns surgeons, obstetricians, and physicians. L'exploration de l'incontinence anale doit comporter de nombreux examens objectifs et notamment la manométrie, les tests de continence, et l'électromyographie. La manométrie sert à prédire l'avenir fonctionnel et à calibrer la réparation sphinctérienne. Les défects anatomiques purs de la musculature anale et pelvienne méritent une correction chirurgicale avec ou sans suture en paletot des extrémités musculaires. Pour les réparations en deux temps, l'intervalle séparant les deux étapes devrait être au moins de trois mois. Il faut fabriquer une colostomie de protection dans certains cas complexes et en cas de complication septique. Avant de proposer la fermeture de la colostomie, il faut ré-évaluer la fonction ano-rectale. On arrive à restaurer une continence acceptable chez la plupart des patients, le résultat définitif dépendant surtout de l'importance du défect local et de la sévérité de la neuropathie associée du plancher pelvien. La transposition d'un muscle squelettique reste une méthode esotérique, à n'utiliser que chez certains patients bien sélectionnés; l'implantation d'un stimulateur neuromusculaire paraît justifiée. En présence d'anomalies fonctionnelles sphinctériennes importantes, d'autres méthodes conservatrices sont plus efficaces. Une réparation post-anale est à envisager 3 à 12 mois apès une rectopexie ou une reconstruction sphinctérienne. L'incontinence, basée sur des données purement fonctionnelles, doit être traitée d'abord par des méthodes conservatrices. Une réparation post-anale peut améliorer la situation chez deux-tiers des patients, mais généralement ne réussit pas chez les patients qui en ont le plus besoin. Les échecs sont surtout en rapport avec la continuation du processus neuropathique. L'implantation d'une prothèse péri-anale est une alternative valable dans de tels cas. La sigmoidostomie est une solution radicale de dernier ressort. La prévention de l'incontinence fécale est le facteur le plus important et concerne tous les chirurgiens, obstétriciens et médecins. Los pacientes incontinentes deben ser investigados en forma comprensiva mediante pruebas objetivas, especialmente la mamometría, los examenes de continencia y la electromiografía. La mamometría es de utilidad en la predicción del resultado funcional y en la calibración de una reparación del esfínter. Los defectos anatómicos puros de la musculatura anal y pélvica merecen corrección quirúrgica con y sin superposición de los cabos de los músculos. Si se decide posponer la reparación, ésta debe entonces hacerse luego de un intervalo de tres meses. En los casos complejos y en aquellos con complicaciones sépticas se debe construir una colostomía protectora; en tales pacientes se debe valorar la función ano-rectal antes de proceder con el cierre de la colostomía. Se puede restaurar continencia de grado aceptable en la mayoría de los pacientes, peroel resultado depende de la magnitud de los defectos locales y de la gravedad de la neuropatía concomitante del piso pélvico. La transposición del músculo esquelético sigue representando un aproche esotérico que debe ser usado solamente en pacientes seleccionados; parece justificada la implantación de un estimulador Neuromuscular. En presencia de déficits funcionales importantes la reparación del esfínter puede dar lugar a una situación en la cual medidas conservadoras adicionales resultan más efectivas. Una reparación post-anal puede ser considerada 3–12 meses después de une rectopexia o de una reparación del esfínter. La incontinencia por defectos funcionales puros es tratada en forma conservadora en un principio. Una reparación post-anal puede mejorar la situación en dos tercios de los pacientes, pero falla en los pacientes que más la necesitan. La falla parece estar relacionada con el proceso neuropático continuado. Una alternativa válida puede ser el implante de una banda perianal protésica. La sigmoidostomía es un procedimiento que sólo debe ser emprendido en última instancia. La prevención de la incontinencia fecal es de la mayor importancia y concierne a los cirujanos, obstetras e internistas.