fabio project: development of innovative customized medical devices through new biomaterials and additive manufacturing technologies.
In the short term, current clinical vision includes the gradual inclusion of adapted and customized medical devices for patients in surgical and rehabilitation treatments.
Nowadays, patients have higher requirements for the quality, function and safety of treatment.
These goals must be achieved without a biological compatibility problem.
To successfully meet these requirements, the best way to do so is through the complete personalisation of medical devices.
However, a medical staff member
Equipment manufactured with traditional technology may mean economic and time costs that industry cannot afford.
Therefore, the new additive manufacturing technology is the best choice for obtaining such products.
Additive manufacturing refers to the name of all technologies that can directly produce parts or final products.
Get the entire 3D part by adding material layer by layer from the 3D CAD file.
The main advantage of this technology is that it can be freely designed and built in one stage without the need for tools (molds,etc. )
Design complex pieces or final items.
In many cases, they are unique manufacturing solutions (
In addition, compared to other manufacturing technologies such as injection molding or CNC milling, they constitute an economical alternative for manufacturing small series of products with complex geometry, as do custom products.
With the development of manufacturing technology, the success is complete.
Functional custom products with applications in many industrial fields.
However, in the field of biomedicine, especially in the field of implants, the biological compatibility of materials is necessary.
Therefore, it limits the scope of medical application of existing additive manufacturing technology.
At present, there are very few compatible biological materials-
Processed by additional manufacturing technology--
Allows the development of customized medical devices for patients while meeting quality, functionality, safety and biocompatibility requirements.
In addition, in the case of materials that can be processed, the cost of product certification--
The necessary steps before putting it on the market-
In order to compensate for this cost, we are always forced to consider a large series of products.
In this case, the FABIO project was proposed with the aim of demonstrating the ability to develop and apply new biological materials and additive manufacturing technologies to obtain innovative customized medical device production.
To this end, three extensive, differentiated and interrelated studies were conducted :(i)
Identification and generation of metal and polymer biological materials that can be treated by additive technology; (ii)
At present, the application of additive technology in biological material processingand, (iii)
Develop design methods for new custom medical device generation. 2.
Development of work
The plan for the Fabio project is built at the following stages, as shown in Figure 1, interdependent.
Four customized medical devices were selected and developed to show that the target was met.
These examples include (see Figure 2)
Ankle-socket for amputees through the shin
Foot surgery to repair joint rigidity, bone replacement of bone defect at critical size and femoral stem of hip prosthesis. [
Figure 1 slightly][
Development process of cross-tibia litter (
External medical devices for polymer materials)
And the hip joint (
Implantable medical devices for metal materials)
Described in the paragraph below.
The Trans-tibia litter is a basic part of the prosthetic limb of the member amputee at the Trans-tibia level.
It must provide the surface and transfer the body weight from the stump to the prosthesis.
The development process of customized socket through tibia amputee (Figure 2)
Start with data collection from Manual 3-
Size optical scanning of the patient.
Computer-aided design software (3D CAD)
Digital for patient residual limb geometry.
By best fitting the load transfer between the pile and the pile, the design of the pile is determined.
A post-analysis evaluation of the design was performed using a finite element model.
The Transtibial socket CADdesign file is used to build parts directly with polymer resin in stereo molding (SLA)
According to Spanish standard UNE-, the product is carried out under static mechanical testing and cyclic loading
En iso 10328: 2007, passed the test smoothly.
The medical staff and the end patient evaluated the product to check whether the product was correctly adjusted and functional during use.
The femoral stem is a hip prosthesis that replaces the femoral head.
Customized development of the femoral stem for hipprostsis (Figure 2)
From a cat. scan (
The patient\'s leg.
The femur is divided using a specific image processing software.
After the segmentation is completed, in order to design the hip prosthesis, the data is imported into CAD software.
Make the geometry of the femoral stem as consistent as possible with the patient\'s femoral channel.
A interconnected porous region was designed with the help of a computer to enable the bone to grow appropriately towards the internal region of the femoral stem, thus keeping the implant in place and increasing its stability.
Just like the cross-tibia litter, the design was analyzed and evaluated before the product was manufactured with a finite element model.
Using the CAD design file of the Strand piston rod, the parts with implanted titanium alloy were directly constructed during electron beam smelting (EBM)
According to international standard ISO 7206-place the femoral handle under mechanical test
4: 2002, the result is satisfactory, the product can withstand normal mechanical operation once implanted. 3.
Conclusion The goal of the FABIO project is to obtain a new customized medical device product that can be manufactured with the economic and time costs that the industry can bear.
These products can improve welfare, reduce troubles, shorten recovery time, reduce the possibility of requiring a second surgical intervention, and improve the quality of life of patients.
The four prototypes developed within the framework of the project meet the requirements for the quality, safety, functionality and biocompatibility of customized medical devices, a necessary step before they can be brought to market.
In addition, with its high added value, it is able to increase the supply of biological materials, manufacturing technology and highly competitive customized medical devices.
Everything is delivered to the industry through an integrated service and support chain through a collaborative platform.
The services generated in the Fabio project can also be used in the future by other industrial sectors that require personalized products. 4.
Other participants in FABIOproject must be specifically mentioned: Liceth Rebolledo (ASCAMM)
Inigo Morales (IBV)
And EnriquePinazar (INASMET).
Special mention must also be made of the great contribution of Louis Potter (AIMME)
Carlos in a double observation (IBV)
Whether it\'s their knowledge or their rich experience. 5.
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