Design process is putting together of program or tentative projects with an aim of creating a product. Along with basic elements of design process are the enterprise of objectives and criteria, synthesis, analysis, construction, testing and evaluation. In the case of this project, the process involves a simulation of the Gore Excluder AAA End prosthesis with the aim of using it to correct an abdominal aortic aneurysm.
The process involves series of activities and steps as outlined below: RESEARCH This is a performance research. This aims toward upgrades of the Excludercreated by Gore so as to demonstrate how it can be able to treat the life threatening abdominal aortic aneurysm. The parameters and concepts that rule the design step is the analysis of blood flow into the thoracic aorta and into the abdominal aorta which the centre of focus. DESIGN The Design Step carries an idea of a finished set of drawings or other media that administer how to build a physical sample. Preliminary Design: This step sets the goal for the appearance and performance of the Gore Excluder AAA End prosthesis, with less concern about how to manufacture. The result becomes the framework to organize and direct a detailed, final design.
the model requires the following for its manufacture; Mechanical -There must be blood flow within the model -The model must have an aorta looking feature -The model must have a clear incasing for protection and demonstrative purposes Constraints -Be aesthetically pleasing -Successfully simulate an abdominal aortic aneurysm -Be easy to transport with minimal chords protruding from the model -The model must be 50 lbs or lighter -Must have thoracic aorta, abdominal aorta, right and left common iliac arteries -Body must be similar to human tissue -The heart beat must resemble an average human’s heartbeat which is about 74 beats per minute -Body must also be clear to see the procedure as it progresses -Must be kept around 98.6 degrees Fahrenheit Electrical: -The three sensors needed are: o The blood flow rate o The temperature of the model o The pressure in the aorta -The sensors must be able to send data to a TV, laptop, smart phones, LCD screen, or any other similar electronic devices -There must be at least one switch for turning off and on the power to the model -The model must be able to fully function off of the power supplied by a standard outlet Constraints -Must have FPGA to display outputs and to control the system -FPGA could get hot, so might need a cooling system such as an electrical fan Environment -The model must be able to withstand a minimum range of temperatures from 52 to 92 degrees Fahrenheit externally -The model must be able to withstand minimal shock and vibration and if it cannot, it must have a casing or protective cover to do so Final Design It specifis everything needed to manage production. 1. Dry Seal Sheath and GoreDry Seal Valve tools 2.
GoreExcluderAAA End prosthesis Bill of quantities DESIGN ANALYSES These verify performance, like fit or strength or weight, prior to building a physical prototype. This step lowers the cost and performance risks associated with prototype and test. Under this step the following are factored in; Sustainability; -The model must be able to function through a span of 10 to 20 years -The model must be “waterproof” internally and a little externally -The model must be able to sustain minimal damage it may take over time from users and unexpected incidences TESTING: This model is solely used for demonstration purposes to show people how the Gore® Excluder® AAA End prosthesis works. During this procedure, the model must have an opening by the groin so the demonstrator can perform the procedure as realistically as possible.
The rest of the features of the model must also represent the real life procedure. For example, when the device is inserted into the groin, it must be able to travel up to the aorta and lower the pressure in the aorta. To make it as realistic as possible, the model must be able to be operated on by standard medical tools used on real patients. - The model must be able to simulate the real life procedure - The model must be able to be operated on by the same tools used on real patients HAZARD ANALYSIS: The goal of the hazard analysis is to identify any potential safety issues that may be presented by the product. Health and Safety: -The model must not produce any dangerous chemicals, substances, or air pollutants -The model must not be flammable -The model must have protection in case of surges in the electrical source -The model must externally be fully protected by any of the electrical components inside that could cause harm -The model must be safe to put together Social: -The model must not be offensive to the general public in anyway o The model must not include any inappropriate body parts o The model must not have any religious markings -The model must be presentable in the appropriate situation such as a hospital -The model must not portray a certain group of people MANUFACTURE AND RELEASE: The final part of the development process is placing the product into production and presenting it to the market.