At the beginning of the journey, the headband shape was chosen as the ELVIS V concept, as it reflects the overall ideology of the ELVIS V product as closely as possible.
The red hoop was the first concept for the ELVIS V system, and it was in this form that the first prototypes of the system were developed, which the project team demonstrated at many events and exhibitions.
Subsequently, the hoop concept was heavily redesigned and the new prototypes (blue design) have a more anatomical shape and a significantly optimised internal layout.
The belt unit in the blue version of the design also underwent a large number of changes, but retained its layout and basic electronics.
ERGONOMICS (2021 – 2022)
Fixation options on the patient's head
After a large number of tests, the hoop concept proved to be the most optimal, but the next technological issue was the secure fixation of the system on the patient's head.
As a result, the design of the hoop (blue version) was modified to ensure a better fit of the system to the patient's head, and a new special mechanism for fixation on the head was designed and implemented.
FIXATION HOOP
The first hoop models were tested on a large number of virtual patient ‘heads’ in a simulation environment. Different designs were also tested for stiffness in CAD/CAM systems.
The prototypes were further tested on a large number of volunteers. The system of fixing the hoop on the head showed good results.
CURRENT DESIGN (2023 – 2024)
The most secure fixation
The hoop variants were well received by the patients and volunteers we recruited to test the prototypes. However, the project team was still looking for the best way to fit the transmitting part of the hoop (located on the back of the head) to the receiving unit in the patient's head.
As a result, the design and construction of the head portion of the system was again modified. In order to test the hypothesis that the transmitter unit would fit securely on the head, the design of the wearable part was completely changed. In the course of the experiments, the volunteers were not only used to test the various modifications of the system, they also served as models for the three–dimensional models of the patients' heads that the project team created.
Experimentation resulted in a head–worn part design as an intermediate version, which is very different from previous instances (hoops). The key difference was a stronger attachment and fixation system on the head, due to opposing attachment points on the head (forehead and occiput).
In numerous experiments, it has been confirmed that this method allows the ELVIS V system to be fixed sufficiently securely to the patient's head and gives the necessary degree of fixation to the occipital part.
Supplement
Options that don't exist
Many of the things developed in the process are not approved by the team and are not taken into further work for various reasons. The process of medical device development requires a company to take into account a huge number of different factors.
And much remains in design and will never be realised in the form of prototypes and real devices.
Implantable part
A separate big scientific challenge
In this article we have only touched upon the design of the external (non–implantable) part of the system. A separate team is working hard to take into account all the nuances in the design of the implantable module. We will talk about this task in a new article.
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