Produktutveckling av suturankare för artroskopi

Sammanfattning: ABSTRACT The following report is a part of a thesis project for product development at an undergraduate level. The originator of the project is Orthopedic Care Scandinavia AB that is located in Stockholm and is focused on medical technology. The thesis comprises 15 credits and is carried out the spring semester of 2015 by the two authoring mechanical engineering students at Mälardalen University. The mission includes a product development concept of a surgical instrument detail used in endoscopic surgery. The detail is a suture anchor that is especially adapted to attach sutures for arthroscopic surgery, mostly for hip and shoulder repairs. The product development project has been conducted after an extensive study in medical technology and the regulations that are relevant for working in this subject area. The originator Ortopedic Care Scandinavia AB ordered the project with the hope of getting a concept that they would be able to patent, manufacture and produce for resale. The originator wanted a suture anchor with a simple mounting method, and with smaller dimensions than the suture anchors they are currently using. The product development study was based on the following problem formulation: • Does the product simplify the technical procedure for attachment of the suture when working with arthroscopy? • What is the most e fficient way to optimize the tension in the thread while putting the suture anchor into place? • What kind of changes of existing technical solutions is required for a new suture anchors to achieve a sufficient inventive step to be patentable? To achieve the goal of creating a new type of suture anchors the product development group made a comprehensive theoretical framework that includes both medical technology and product development. In order to scientifically establish its result a number of product development tools were used, including a competitive analysis of existing products in the market which analyze different types of fastening techniques and validate various properties of suture anchors. The result of the project work became the suture anchor Enkel Infästning that is presented in rendered CAD images and a description of the intended fastening technology. Arguments for height of the technical solution and what makes this invention patentable is presented in the results. Manufacturing method and strength strain is presented using computer-aided design tools where the simulation of injection molding is made and FEM analysis demonstrates that the construction of the product will contain for the intended purpose.