Abstract
The non-invasive intracranial pressure (NIICP) method based on a skull deformation has been proven to be a significant tool for an assessment of the intracranial pressure (ICP) and compliance. Herein, we present the development and characterization of a novel wireless sensor that uses this method as its working principle and was designed to be easy to use, to have a high resolution, and to achieve a good accessibility. Initially, a brief review of the physiology fundamentals of the ICP and the historic evolution of the NIICP method are mentioned. The sensor architecture and the rationale for the chosen components are then presented, aiming to ensure nanometer displacement measurements, the conversion of analog resolution to digital at a high speed, the fewest amount of distortion, wireless communication, and signal calibration. The NIICP signal has a typical amplitude of <inline-formula xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink"> <tex-math notation="LaTeX">$5~\mu \text{m}$ </tex-math></inline-formula> , and thus a resolution of at least 1% of this amplitude is required for an NIICP waveform analysis. We also demonstrate a 40-nm resolution of the sensor using a nanometric displacement test system that can also respond dynamically for NIICP signals from 50 to 180 bpm without any significant distortion (maximum deviation of P2/P1 ratio of 2.6%). The future applications for this device are broad and can enhance a clinical assessment of the intracranial dynamics.
Highlights
I NNOVATION applied to neurology and neurosurgery advanced in the 1970s with the invention of computedManuscript received April 29, 2021; revised June 9, 2021; accepted June 10, 2021
We describe here the development of a medical device using a nanometer resolution wireless sensor for non-invasive intracranial pressure (ICP) (NIICP) monitoring based on the principles presented by Oliveira et al [47]
These non-invasive intracranial pressure (NIICP) studies [74]–[77] presented good evidence that the method is strong in an ICP waveform analysis, allowing the development of a medical device applying a noninvasive assessment of intracranial dynamics and compliance in a commercial manner
Summary
I NNOVATION applied to neurology and neurosurgery advanced in the 1970s with the invention of computed. Expanding this hypothesis, a further in vivo experiment conducted by Vilela et al [75] validated a minimally invasive ICP monitoring method through a comparison to the standard IICP. None of the studies mentioned [74]–[76] were able to establish a direct relationship between NIICP and the absolute values of IICP These NIICP studies [74]–[77] presented good evidence that the method is strong in an ICP waveform analysis, allowing the development of a medical device applying a noninvasive assessment of intracranial dynamics and compliance in a commercial manner. The transducer working principle (Subsection III-B) of the first NIICP wired sensor (Model BcSs-PICNI2000, Braincare Desenvolvimento e Inovação Tecnológica S.A., Sao Carlos, Brazil) launched commercially in 2017 was applied to the current wireless version described below (Model BcSs-PICNIW-1000, Braincare Desenvolvimento e Inovação Tecnológica S.A., Sao Carlos, Brazil)
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