Minimally Invasive Surgery (MIS) is a growing field including both laparoscopic androbotic operations. Surgeons and engineers are making continual efforts to reduce the negative effects of procedures on patients. Reducing the size of the surgical instruments is one effective method pursued in this effort. When the instruments approach 3 mm in diameter, they reach a threshold where the entry incisions can be small enough that no scar is left on the patient. Laparoscopic instruments on this scale exist but typically lack wrist articulation and only have 1 degree of freedom (DoF). Alternatively, robotic surgical instruments can achieve high levels of dexterity but at a greater diameter. Smaller diameter robotic instruments employ snake wrists but this results in large swept volumes. There is a need for smaller robotic instruments with 3 DoF that preserve a small operational volume. Several unique challenges result when trying to develop small-scale instruments. Friction forces due to the relative motion of actuation cables and other parts in the mechanisms become more significant, as do the challenges of producing and assembling parts with extremely small features. These challenges have been limiting factors for the size of instruments. Traditional mechanisms use pin joints and pulleys which result in higher part counts and higher internal friction. To overcome these challenges, two alternative designs that reduce part count and minimize friction are presented as potential mechanisms that could be used as surgical instruments on the mesoscale (1-5 mm). Both designs implement rolling contact and gearing in place of pin joints and pulleys to realize their motion. Additionally, alternative manufacturing methods that are ideally suited to mesoscale production are presented. Micro metal laser sintering and composite carbon nanotude structures are shown to have the resolution required to create the detailed features necessary for these new designs. The result are two mechanisms suited to be produced as mesoscale, robotically actuated, surgical instruments. One of the two designs has been physically prototyped and has demonstrated clinical capabilities at 4 and 5 mm diameter instrument sizes.

This study was an investigation into the cost-effectiveness of using re-usable instrumentation in laparoscopic surgery. The model used for the study was the laparoscopic cholecystectomy which is the commonest laparoscopic procedure performed by the general surgeons. The study was done at KZNGOV Hospital in Kwazulu Natal, one of the largest tertiary hospitals in the province. The research done was both qualitative and quantitative. An exploratory study was conducted initially by drawing up the case study, and then quantitative and qualitative research was conducted to evaluate the use of re-usable instrumentation in laparoscopic surgery. In order to conduct a more focused design, the three most commonly used laparoscopic instruments were evaluated. These were the trocars (sizes 11.0mm and 5.0mm), the endoshears / scissors and the clip applicators. The study aimed to assess whether the use of the re-usable instruments was more cost-effective, whether their use in minimal access surgery was feasible, and whether the use of re-usable instrumentation compromised patient well-being. Information for the case study was obtained from the hospital notes of the patients who had a laparoscopic cholecystectomy at KZNGOV Hospital, and from interviews with experienced surgeons. The study found that the re-usable instrumentation used at KZNGOV Hospital had no adverse effects on the patients. The Department of Surgery and the theatre committee at this hospital have chosen an excellent and cost-effective protocol for laparoscopic surgery, and the choice of instrumentation cannot be faulted. Analysis of the results showed a large cost saving obtained by using the re-usable laparoscopic instrumentation, with no adverse patient outcomes. / Thesis (MBA)-University of KwaZulu-Natal, Durban, 2003.

As progressivas inovações tecnológicas, na área de projeto mecânico, contribuem para a adoção de novos procedimentos cirúrgicos relacionados à ortopedia. Este trabalho trata do projeto, desenvolvimento e fabricação de dispositivos de usinagem e instrumentais cirúrgicos para aplicação em cirurgias de recapeamento da cabeça femoral em humanos e animais, buscando aperfeiçoar tal procedimento no que diz respeito a tecnologias voltadas à modelagem óssea e furação centralizada com a cabeça femoral. Nesse contexto, a relação tempo x precisão foi muito bem explorada, de forma a auxiliar com eficiência os cirurgiões e os pacientes que necessitam dessa cirurgia reduzindo a interferência da habilidade do cirurgião no resultado final da cirurgia. A fresa multilaminar sequencial, criada para usinar a cabeça femoral conforme geometria interna da prótese de recapeamento de quadril é uma importante ferramenta para redução do tempo de cirurgia, uma vez que é necessária a troca de ferramentas durante os procedimentos cirúrgicos como mostrado nesta tese. O instrumental cirúrgico, responsável para o funcionamento correto desses dispositivos de usinagem, é um guia de furação personalizado capaz de alinhar a broca e a fresa durante a modelagem da cabeça femoral, de acordo com o ângulo do colo femoral de cada paciente. Assim, este trabalho trata da concepção, desenvolvimento e fabricação de protótipos de um dispositivo de usinagem e instrumentais cirúrgicos que promovam a usinagem centralizada seguindo o ângulo do colo femoral, redução do tempo de cirurgia e da aplicação cirúrgica com prótese de recapeamento artroplastia de recapeamento canina. Os produtos desenvolvidos nesse trabalho serão nomeados como \"fresa multilaminar sequencial\", \"máscara para furação centralizada\" e \"prótese e instrumentais cirúrgicos para cães\", para a artroplastia de recapeamento de quadril. Com os desenvolvimentos, é esperada uma redução no tempo da cirurgia, bem como um aumento na segurança, possibilitando maior sucesso nesses procedimentos em humanos, bem como trás nova tecnologia para a medicina veterinária. / Progressive technological innovations in the area of mechanical design, contribute to the adoption of new surgical procedures related to orthopedics. This work addresses the design development and manufacture of machining devices and surgical instruments to be used in resurfacing surgeries of the femoral head in humans and animals, seeking to improve this procedure in regards to a new technology related to bone structure for machining and drilling aligned with the femoral head. In this context, the relation time c accuracy was very well explored, in order to assist with efficiency surgeons and patients requiring surgery that reduces the interference on the skill of the surgeon on the surgery outcome. The simultaneous development of the multilaminar-mill, designed to machine the femoral head matching the internal geometry of the resurfacing prosthesis is an important tool for reducing the surgery time, as the tool changes during surgery as shown this thesis. The surgical instrument responsible for the proper operation of these machining devices is a customized guide drill mark capable of aligning the drill and the mill during drilling and milling of the femoral head, according to the angle of the femoral neck of each patient. This work deals with the design, development and manufacturing of a machining device prototype and surgical instruments to promote the centralized machining following the angle of the femur neck the reduction of surgery time and the innovate arthroplasty surgery in humans animals. The products developed in this work are named as \"sequential multilaminar mill\", \"drilling centering mask\" and \"prosthesis and instrumental for dogs\", for hip resurfacing arthroplasty. With the developments, it is expected to reduce the surgical time, as well increasing safety, allowing greater success in these procedures.

As progressivas inovações tecnológicas, na área de projeto mecânico, contribuem para a adoção de novos procedimentos cirúrgicos relacionados à ortopedia. Este trabalho trata do projeto, desenvolvimento e fabricação de dispositivos de usinagem e instrumentais cirúrgicos para aplicação em cirurgias de recapeamento da cabeça femoral em humanos e animais, buscando aperfeiçoar tal procedimento no que diz respeito a tecnologias voltadas à modelagem óssea e furação centralizada com a cabeça femoral. Nesse contexto, a relação tempo x precisão foi muito bem explorada, de forma a auxiliar com eficiência os cirurgiões e os pacientes que necessitam dessa cirurgia reduzindo a interferência da habilidade do cirurgião no resultado final da cirurgia. A fresa multilaminar sequencial, criada para usinar a cabeça femoral conforme geometria interna da prótese de recapeamento de quadril é uma importante ferramenta para redução do tempo de cirurgia, uma vez que é necessária a troca de ferramentas durante os procedimentos cirúrgicos como mostrado nesta tese. O instrumental cirúrgico, responsável para o funcionamento correto desses dispositivos de usinagem, é um guia de furação personalizado capaz de alinhar a broca e a fresa durante a modelagem da cabeça femoral, de acordo com o ângulo do colo femoral de cada paciente. Assim, este trabalho trata da concepção, desenvolvimento e fabricação de protótipos de um dispositivo de usinagem e instrumentais cirúrgicos que promovam a usinagem centralizada seguindo o ângulo do colo femoral, redução do tempo de cirurgia e da aplicação cirúrgica com prótese de recapeamento artroplastia de recapeamento canina. Os produtos desenvolvidos nesse trabalho serão nomeados como \"fresa multilaminar sequencial\", \"máscara para furação centralizada\" e \"prótese e instrumentais cirúrgicos para cães\", para a artroplastia de recapeamento de quadril. Com os desenvolvimentos, é esperada uma redução no tempo da cirurgia, bem como um aumento na segurança, possibilitando maior sucesso nesses procedimentos em humanos, bem como trás nova tecnologia para a medicina veterinária. / Progressive technological innovations in the area of mechanical design, contribute to the adoption of new surgical procedures related to orthopedics. This work addresses the design development and manufacture of machining devices and surgical instruments to be used in resurfacing surgeries of the femoral head in humans and animals, seeking to improve this procedure in regards to a new technology related to bone structure for machining and drilling aligned with the femoral head. In this context, the relation time c accuracy was very well explored, in order to assist with efficiency surgeons and patients requiring surgery that reduces the interference on the skill of the surgeon on the surgery outcome. The simultaneous development of the multilaminar-mill, designed to machine the femoral head matching the internal geometry of the resurfacing prosthesis is an important tool for reducing the surgery time, as the tool changes during surgery as shown this thesis. The surgical instrument responsible for the proper operation of these machining devices is a customized guide drill mark capable of aligning the drill and the mill during drilling and milling of the femoral head, according to the angle of the femoral neck of each patient. This work deals with the design, development and manufacturing of a machining device prototype and surgical instruments to promote the centralized machining following the angle of the femur neck the reduction of surgery time and the innovate arthroplasty surgery in humans animals. The products developed in this work are named as \"sequential multilaminar mill\", \"drilling centering mask\" and \"prosthesis and instrumental for dogs\", for hip resurfacing arthroplasty. With the developments, it is expected to reduce the surgical time, as well increasing safety, allowing greater success in these procedures.

Patients who have undergone treatment that has included the surgical implantation of a prosthetic device can become dissatisfied for many reasons. One cause for dissatisfaction is any adverse event where there is a demonstrable causal nexus with the failure of a device that is defective or at risk of being so. The magnitude of therapeutic product failure is considerable and therapeutic goods such as Vioxx, Thalidomide, silicon-gel-filled breast implants, contaminated blood products, cardiac pacemakers and valves, and orthopaedic devices are testimony to this. Many of these events have exposed a greyish area of Australian law that balances medical negligence with consumer protection and contract law. Australian product liability legislation that regulates the use of therapeutic goods is a complex amalgam of law that has at its foundations the Trade Practices Act 1974 (Cth) and the Therapeutic Goods Act 1989 (Cth). When a surgical device fails there can be exposure to liability. This thesis explores those important issues that can impact on individuals or on organisations and it is evident that where issues of product liability concern implanted surgical devices the current regulations for consumer protection may not always be the most appropriate. It is evident that there is a culture of under-reporting of adverse events to a Therapeutic Good Administration that does not have the resources to investigate the cause for failure of a surgical device. Furthermore, there is a potential for bias and conflict of interest in an environment where the regulator depends on the regulated for the funding of its existence. Other issues include the complex and often undesirable consequences of those partnerships that can evolve with the development of an implantable device and with the undertaking of clinical trials, the role of the learned intermediary, that interface between manufacturer and consumer, and the role of the expert witness, that interface between justice and injustice. These and other matters that can significantly influence any debate of implantable surgical device product liability are explored and recommendations are made that might form the basis of a Therapeutic Goods (Safe Medical Devices) Amendment Act.

Patients who have undergone treatment that has included the surgical implantation of a prosthetic device can become dissatisfied for many reasons. One cause for dissatisfaction is any adverse event where there is a demonstrable causal nexus with the failure of a device that is defective or at risk of being so. The magnitude of therapeutic product failure is considerable and therapeutic goods such as Vioxx, Thalidomide, silicon-gel-filled breast implants, contaminated blood products, cardiac pacemakers and valves, and orthopaedic devices are testimony to this. Many of these events have exposed a greyish area of Australian law that balances medical negligence with consumer protection and contract law. Australian product liability legislation that regulates the use of therapeutic goods is a complex amalgam of law that has at its foundations the Trade Practices Act 1974 (Cth) and the Therapeutic Goods Act 1989 (Cth). When a surgical device fails there can be exposure to liability. This thesis explores those important issues that can impact on individuals or on organisations and it is evident that where issues of product liability concern implanted surgical devices the current regulations for consumer protection may not always be the most appropriate. It is evident that there is a culture of under-reporting of adverse events to a Therapeutic Good Administration that does not have the resources to investigate the cause for failure of a surgical device. Furthermore, there is a potential for bias and conflict of interest in an environment where the regulator depends on the regulated for the funding of its existence. Other issues include the complex and often undesirable consequences of those partnerships that can evolve with the development of an implantable device and with the undertaking of clinical trials, the role of the learned intermediary, that interface between manufacturer and consumer, and the role of the expert witness, that interface between justice and injustice. These and other matters that can significantly influence any debate of implantable surgical device product liability are explored and recommendations are made that might form the basis of a Therapeutic Goods (Safe Medical Devices) Amendment Act.

Thesis--University of Oklahoma. / Bibliography: leaves 77-85.

Over the past two decades a body of evidence concerning residual biological contamination on cleaned surgical instruments has accumulated. This is substantiated by the number of yearly surgery cancellations due to visible residue on instruments in surgical packs and incidences of iatrogenic Creutzfeldt-Jakob disease (iCJD). It is therefore imperative to develop a method of protein detection for use in clinical sterile services departments (SSDs) for monitoring of decontamination quality. This Thesis describes the development and use of an epifluorescence surface scanner (EFScan) technology in the assessment of proteinaceous residue on surgical instruments, by detecting protein pre-labelled with fluorescein isothiocyanate (FITC), and exploratory studies on the feasibility of label-free detection, using intrinsic protein fluorescence. Measurements using FITC labelling showed that residual protein on the order of micrograms can be found on new, single-use instruments (i.e. prior to use). This is comparable to the amount of residual protein found on retired, reusable instruments. To confirm the suitability of fluorescence techniques in the detection and quantification of proteinaceous residue, a blind, pilot study was carried out in conjunction with groups from Queen Mary University and the University of Southampton. Each University used a different labelling and detection method, and results showed good agreement between these methods. This showed that fluorescence is a suitable technique for the detection and quantification of proteinaceous contamination on surgical instruments. The next step in the project focussed on detection of contamination via intrinsic protein fluorescence from tryptophan residues, with a view to elimination of the labelling step. Intrinsic fluorescence of proteins in solution is widely characterised; however, fluorescence characteristics of solid or surface-bound protein have been little studied. Therefore, the characterisation of solid protein fluorescence and the emission characteristics of protein adsorbed onto stainless steel was undertaken. Analysis of the commonly used protein standard bovine serum albumin (BSA) showed that the two tryptophan residues it contains are highly susceptible to photo-oxidation in the solid state, resulting in conversion to the fluorescent photoproducts n-formylkynurenine (NFK) and kynurenine. Therefore, BSA is not suitable for use as a standard in the development of intrinsic fluorescence detection of surface-bound protein. The 72-tryptophan protein fibrinogen, as well as a series of other multi-tryptophan proteins, were assessed and it was found that photo-oxidation of the tryptophan residues did not occur on the irradiation timescale of 1 hour utilized. Therefore, it was concluded that lysozyme or gamma-globulins, a prominent group of serum proteins, would be more suitable candidates as a standard in subsequent research into the intrinsic detection and quantification of proteinaceous contamination. A third study explored the potential use of fluorescence in the early diagnosis of cataract. This involved the fluorescence characterisation of healthy porcine lenses and the use of UV irradiation of the lens to attempt to create cataract in vitro. There was found to be a large variation in fluorescence characteristics from lens to lens, suggesting that fluorophore concentrations can vary significantly. This implies that identification of a suitable standard for the early detection of cataract may be problematic. Attempts to create cataract resulted in the photo-oxidation pathway which had been observed in BSA, and although NFK and kynurenine play a role in cataractogenesis, the accumulation of these photoproducts is not analogous to a natural cataract. It was found that these products could be destroyed by irradiation of the lens at appropriate photo-bleaching wavelengths. However, this also destroyed intrinsic, protective fluorophores within the lens, suggesting that a light-based method of cataract treatment may not be achievable.

Neste trabalho foram utilizados os conceitos de célula flexível de manufatura e de automação utilizando a robótica para desenvolver uma célula robotizada de acabamento de instrumentos cirúrgicos forjados, com o objetivo de obter aumento de produção e flexibilizar o sistema de manufatura. Na produção manual de acabamento dos instrumentos cirúrgicos incluídos no estudo são realizados processos de lixamento, eletropolimento, polimento vibratório, jateamento e polimento com manta sintética e escova. Foi identificado que o sistema utilizando trabalho manual restringe a produtividade a um número de pinças insuficiente para atender à demanda do mercado. Desse modo, foi desenvolvida uma célula robotizada de acabamento, com a intenção de suprir a necessidade do aumento de produção dos instrumentos cirúrgicos. Em paralelo ao desenvolvimento da célula flexível de manufatura, estudaram-se os processos de acabamento utilizados, resultando na eliminação de etapas de acabamento no processo automatizado. Com a célula flexível de manufatura desenvolvida se obteve um aumento de produção de 96,87 % e uma redução nos custos de 50,53 % em relação à linha manual. Os produtos cuja manufatura se deseja automatizar são pinças hemostáticas, de apreensão e de campo que foram selecionadas através da análise da demanda produtiva. A matéria-prima utilizada nestes instrumentos é aço inoxidável martensítico, de denominação AISI 420D. O processo de fabricação utilizado nos componentes é o forjamento, que permite a melhora das propriedades mecânicas, modificando a disposição dos constituintes do material deformado. No entanto, foi avaliada de forma experimental a viabilidade de substituição do forjamento pelo corte laser, visando a eliminação do processo de lixamento dos componentes, com consequente aumento na taxa de produção, o que não foi possível devido à menor resistência obtida pelos componentes assim produzidos. / In this study, were used the concepts of flexible cell manufacturing and automation using robotics to develop a finishing in forged surgical instruments robot cell, in order to get increased production and a more flexible manufacturing system. On completion of the manual production of surgical instruments included in the study of processes are performed grinding, electropolishing, vibratory polishing, sandblasting and polishing synthetic blanket and brush. Was identified that the system using manual labor productivity to a limited number of tweezers insufficient to meet market demand. Thus, was developed a robotic finishing cell, with the intention of meeting the need for increasing production of surgical instruments. In parallel to the development of flexible manufacturing cell, were studied the finishing processes used, resulting in the elimination of finishing steps in the automated process. With the flexible manufacturing cell development was obtained an increase of 96.87% and production cost savings of 50.53% compared to the online manual. The products whose manufacture is desirable to automate hemostat, apprehension and field tweezers that were selected by analyzing the production demand. The raw material used in these instruments is martensitic stainless steel, designations AISI 420D. The manufacturing process used in the components is forginig, which allows the improvement of mechanical properties by modifying the arrangement of the constituents of the deformed material. However, it was experimentally evaluated the feasibility of replacing the forging by laser cutting, in order to eliminate the process of grinding the components, with consequent increase in production rate, which was not possible due to a lower resistance obtained by the components thus produced.

Neste trabalho foram utilizados os conceitos de célula flexível de manufatura e de automação utilizando a robótica para desenvolver uma célula robotizada de acabamento de instrumentos cirúrgicos forjados, com o objetivo de obter aumento de produção e flexibilizar o sistema de manufatura. Na produção manual de acabamento dos instrumentos cirúrgicos incluídos no estudo são realizados processos de lixamento, eletropolimento, polimento vibratório, jateamento e polimento com manta sintética e escova. Foi identificado que o sistema utilizando trabalho manual restringe a produtividade a um número de pinças insuficiente para atender à demanda do mercado. Desse modo, foi desenvolvida uma célula robotizada de acabamento, com a intenção de suprir a necessidade do aumento de produção dos instrumentos cirúrgicos. Em paralelo ao desenvolvimento da célula flexível de manufatura, estudaram-se os processos de acabamento utilizados, resultando na eliminação de etapas de acabamento no processo automatizado. Com a célula flexível de manufatura desenvolvida se obteve um aumento de produção de 96,87 % e uma redução nos custos de 50,53 % em relação à linha manual. Os produtos cuja manufatura se deseja automatizar são pinças hemostáticas, de apreensão e de campo que foram selecionadas através da análise da demanda produtiva. A matéria-prima utilizada nestes instrumentos é aço inoxidável martensítico, de denominação AISI 420D. O processo de fabricação utilizado nos componentes é o forjamento, que permite a melhora das propriedades mecânicas, modificando a disposição dos constituintes do material deformado. No entanto, foi avaliada de forma experimental a viabilidade de substituição do forjamento pelo corte laser, visando a eliminação do processo de lixamento dos componentes, com consequente aumento na taxa de produção, o que não foi possível devido à menor resistência obtida pelos componentes assim produzidos. / In this study, were used the concepts of flexible cell manufacturing and automation using robotics to develop a finishing in forged surgical instruments robot cell, in order to get increased production and a more flexible manufacturing system. On completion of the manual production of surgical instruments included in the study of processes are performed grinding, electropolishing, vibratory polishing, sandblasting and polishing synthetic blanket and brush. Was identified that the system using manual labor productivity to a limited number of tweezers insufficient to meet market demand. Thus, was developed a robotic finishing cell, with the intention of meeting the need for increasing production of surgical instruments. In parallel to the development of flexible manufacturing cell, were studied the finishing processes used, resulting in the elimination of finishing steps in the automated process. With the flexible manufacturing cell development was obtained an increase of 96.87% and production cost savings of 50.53% compared to the online manual. The products whose manufacture is desirable to automate hemostat, apprehension and field tweezers that were selected by analyzing the production demand. The raw material used in these instruments is martensitic stainless steel, designations AISI 420D. The manufacturing process used in the components is forginig, which allows the improvement of mechanical properties by modifying the arrangement of the constituents of the deformed material. However, it was experimentally evaluated the feasibility of replacing the forging by laser cutting, in order to eliminate the process of grinding the components, with consequent increase in production rate, which was not possible due to a lower resistance obtained by the components thus produced.