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Universal expandable acetabular reamer for total hip arthroplasty

Grant number: 15/01003-9
Support type:Research Grants - Innovative Research in Small Business - PIPE
Duration: February 01, 2016 - May 31, 2017
Field of knowledge:Engineering - Biomedical Engineering - Medical Engineering
Principal researcher:Carlos Roberto Fernandes
Grantee:Carlos Roberto Fernandes
Company:Bioemergens Brasil Ltda
City: São José do Rio Preto

Abstract

Total hip arthroplasty (THA) is a widely used surgical procedure, it represents a major advance in biomedical technology and is currently one of the most successful orthopedic procedures. An estimated 285,000 hip arthroplasties are performed each year in the United States, with a fixed cost in surgical instrumental order of $ 400 million dollars. With a THA incidence of 0.04% in the general population, it is expected that up to 81 000 THA will be performed in Brazil every year. The Brazilian Public Health Care system (SUS) has spent US $ 1.2 billion with procedures involving prosthetics, orthotics and special devices in 2013 alone. An essential step in the surgical procedure is the preparation of the acetabular socket and the femoral canal by extracting sufficient bone to receive the prosthetic implants. Acetabular reamers currently used as surgical instruments for bone preparation in THA have several drawbacks such as imperfections in the reamed bony surfaces ( grooves and ridges ) that hinder the perfect fit of the prosthesis ( which may cause the failure of the arthroplasty ). Moreover, the cleaning and sterilization of the various components and the compulsory redundancy of all reamer diameters increase the indirect cost of the implant. We have conducted a preliminary QFD study (Quality Function Deployment) with stakeholders related to the acetabular reamers (surgeons, nurses, cleaning and sterilization personnel, hospital administrators and industry representatives) who identified their needs and their relative importance with respect to the surgical instrumentation. The solution proposed (PI) consists of a universal variable diameter acetabular reamer consisting of a blade assembly, a piston system which activates the system and the adjusting capability provided by a morse-type fixation system that locks the blades in a desired position. Based on this study, we submit this project which involves the final development and improvement of a new universal variable diameter acetabular reamer for hip arthroplasty. The reamer concept has already been validated in previous experimental tests where a fixed diameter simplified prototype confirmed the blades system efficacy. Thus, the overall objective of the project is to improve the existing prototype of the universal reamer by improving the design and the ergonomics of the instrument, by producing a working industrial pre-series prototype and by testing their accuracy and quality characteristics of the reamed surfaces using polyurethane models. This surgical instrument has important advantages over currently marketed tools by reducing the time required for acetabular reaming , the space used in an operating room , the preparation time of the instruments table by the nurse and the time of cleaning and sterilization of instruments. In addition, this instrument fits into the trend of minimally invasive surgery and in the definition of "smart tools" He can fill the needs of the users involved by providing a lower risk of surgical errors, a competitive advantage for the surgical instrumentation and hip prostheses companies, and by offering a competitive edge over the competition both in the final cost of the implant and in user satisfaction. Finally, the success of the project will allow Bioemergens Brazil to enhance the property value and the commercial potential of the invention, accelerating the technology transfer process. The medium term objective (Pipe phase 2 to come) will be to validate its effectiveness and reproducibility on a bovine bone model by comparing their performance with that of a standard commercial reamer. Moreover, to establish an industrial collaboration with a company in hip arthroplasty or surgical instrumentation in Brazil and/or abroad to start pre-series prototype production and to perform industrial and clinical validation (wherever necessary) and for future commercial distribution. (AU)

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