ES2975667A2 - Non-invasive cerebrospinal fluid monitoring devices - Google Patents

Abstract

The invention relates to non-invasive cerebrospinal fluid monitoring devices, comprising a non-invasive cerebrospinal fluid monitor and a multifunctional support base to attempt to improve interventional approaches in the field of anaesthesiology. The monitor performs the function of real-time non-invasive quantification of the flow and pressure of cerebrospinal fluid in the subarachnoid space in the brain, eye and spinal cord, and the multifunctional support base is primarily intended to support the non-invasive cerebrospinal fluid monitor and to modify the hands-free technique in ultrasound-guided anaesthetic procedures.

Description

DESCRIPTION

NON-INVASIVE CEREBROSPINAL FLUID MONITOR AND PROCEDURE

MEASUREMENT OF INTRACRANIAL PRESSURE

BACKGROUND REGARDING INTRACRANIAL PRESSURE AND CEREBROSPINAL FLUID

The following medical data, although different from what is expressed in the present context, are related to current intracranial pressure monitoring, in addition, the medical literature below is intended to serve as references to the present topic related to the assessment of cerebrospinal fluid.

According to the monitoring of Intracranial pressure monitoring published online on the prestigious website MedlinePlus (dated and reviewed on April 21, 2019) and the textbooks cited therein:

> Huang MC, Wang VY, Manley GT. Intracranial pressure monitoring. In: Winn HR, ed.

Youmans and Winn Neurological Surgery. 7th ed. Philadelphia, PA: Elsevier; 2017:chap15.

> Oddo M, Vincent J-L. Intracranial pressure monitoring. In: Vincent J-L, Abraham E, Moore FA, Kochanek PM, Fink MP, eds. Textbook of Critical Care. 7th ed. Philadelphia, PA: Elsevier; 2017: chap E20.

> Rabinstein AA, Fugate JE. Principles of neurointensive care. In: Daroff RB, Jankovic J, Mazziotta JC, Pomeroy SL, eds. Bradley's Neurology in Clinical Practice. 7th ed. Philadelphia, PA: Elsevier; 2016:chap 55.

> Robba C. Intracranial pressure monitoring. In: Prabhakar H, ed. Neuromonitoring Techniques. 1st ed. Philadelphia, PA: Elsevier; 2018:chap 1.

> Handbook of Neurosurgery By Mark S. Greenberg, MD (8th Edition)

There are currently three invasive ways to quantify intracranial pressure according to the article (Intracranial pressure monitoring by MedlinePlus); these are done through the insertion of invasive intracerebral sensors, which include:

a) Intraventricular catheter (most accurate invasive monitoring method)

b) Subdural thyme (bolt)

c) Epidural sensor

All of these previous procedures require craniotomy-type approaches (cranial drilling) for the placement of these sensors, then intracranial pressure is monitored through intracerebral cerebrospinal fluid.

Another different way of measuring intracranial pressure by assessing cerebrospinal fluid is by performing a lumbar puncture; then, an invasive spinal catheter is inserted to obtain the cerebrospinal fluid pressure, as described in the online medical article entitled: Lumbar Puncture and Cerebrospinal Fluid Measurement; written by doctors Alfonso Verdú and María Rosario Cazorla; from the Pediatric Neurology section, Gregorio Marañón Hospital, Madrid, Spain; and the Neuropediatrics Unit of Virgen de la Salud Hospital, Toledo, Spain.

In this same aspect and currently, ICP (intracranial pressure) is also assessed indirectly and noninvasively through the thickness and diameter of the optic nerve sheath by means of ocular ultrasound (considering a DVNO or normal optic nerve sheath diameter when it has a length of 3-4.9 mm). In this sense, specifically and only the diameter of the sheath that covers the optic nerve at the intraocular level (DVNO) is measured by ultrasound.

Another different method to assess intracranial pressure is to examine the arterial system of the circle of Willis using ultrasound or transcranial Doppler ultrasound, this technique also measures blood flow to and within the brain.

In another different study related to the qualitative aspect of certain specific components of the cerebrospinal fluid in newborn children, a team of three Spanish scientists and one British; Javier Jiménez, Carlos Castro, Berta Martí and Ian Butterworth; have developed a device that allows the diagnosis of Bacterial Meningitis in newborns using the high-resolution ultrasound technique through the cranial fontanelles in newborns. These scientists successfully evaluated newborns with the aim of diagnosing meningitis at the La Paz University Hospital, Madrid, Spain.

Other advances are Smart Lenses (contact lenses), which are modalities that cover different topics from the analysis of glucose, cholesterol, alcohol, intraocular pressure mediated mainly by the ocular aqueous humor (useful in the evaluation of glaucoma), augmented reality, three-dimensional visual surround, taking photos and videos.

Another research, different from the approaches to measure intracranial pressure, is being carried out in Vilnius, Lithuania, by neurosurgeon Dr. Saulius Rocka. In this regard, the team of scientists in Lithuania are calculating blood flow parameters in two different regions of the ophthalmic artery using ocular vascular ultrasound in order to determine intracranial pressure.

DEVICE DESCRIPTION

0) It consists of a device related to the field of medicine, which will monitor the cerebrospinal fluid in a noninvasive manner. This monitor will be accompanied by an accessory piece or multifunctional support base.

The device is more specifically related to the area of anesthesiology.

1) The monitor will be able to continuously monitor the pressure of the cerebrospinal fluid in real time and in a non-invasive manner using ultrasound as the technology of choice. The device will determine the force exerted by this fluid in the subarachnoid space of the brain, the eye and at the level of the spinal cord. In addition, the non-invasive monitor will be able to quantify the flow of the cerebrospinal fluid in milliliters.

2) Regarding the multifunctional support base, it will be an accessory piece and is mainly designed to hold the noninvasive cerebrospinal fluid monitor. In addition, this multifunctional support base will be able to correctly modify the hands-free technique in ultrasound anesthetic procedures, since it will be designed to hold both the noninvasive monitor and the ultrasound transducers in anesthesiology.

TECHNOLOGIES IN MEDICINE AND DEVELOPMENT OF NON-INVASIVE CEREBROSPINAL FLUID MONITORING

Regarding the development and functionality of noninvasive cerebrospinal fluid monitoring, two types of medical technologies have basically been selected:

3) First choice ultrasound

4) Laser Doppler (second option), among other technologies in medicine

For reasons inherent to their biophysical properties in medicine, both ultrasound and laser Doppler have the ability to penetrate and trace the meningeal coverings including the interior of the subarachnoid space (space between the arachnoid meninges and pia mater) compartments through which cerebrospinal fluid circulates dynamically.

In this order, there are other technologies that would enter the stage concerning the prototyping of the noninvasive cerebrospinal fluid monitor after the two selected medical alternatives (ultrasound and lasers) have been exhausted. Some of these other medical technologies are: intense pulsed light modified for this case in question, infrared variety, ocular micro pressure techniques and strain gauge type sensors, optical or other digital pressure sensors and finally a modality that includes a combination of ultrasound and lasers.

ULTRASOUND IN THE DEVELOPMENT OF NON-INVASIVE MONITOR

5) Ultrasound has been selected as the first option for the development and operation of the monitor. The device will consist of an ultrasound transmitter and receiver that will provide the Doppler effect and spectrum when emitted by the monitor to the subarachnoid space and general circulation of the cerebrospinal fluid, in such a way and through this mechanism, to scan the flow, speed and pressure of the cerebrospinal fluid. The quantification of the cerebrospinal fluid will be done in different sections of the subarachnoid space continuously and in real time, both at the level of the brain, the second cranial nerve and the spinal cord. The mechanism will consist of quantifying the tension by evaluating the collisions and force exerted between the arachnoid meninges and the pia mater by the cellular and molecular set that make up the entire cerebrospinal fluid or a representative fraction of it on a given area in the subarachnoid space, in such a way, the noninvasive monitor will quantify the kinetics or pressure of the cerebrospinal fluid. An ultrasonic microprocessor unit integrated into the device equipment will be able to evaluate the figures corresponding to the cerebrospinal fluid tension, expressing the results in mm of H20.

6) In this order, the flow rate of the cerebrospinal fluid will be quantified based on the Doppler flow, by evaluating the difference between the flow times in the direction of the circulatory current through which the cerebrospinal fluid travels or against the current or circulation, this in turn will depend on the speed of the flow of the cerebrospinal fluid in the subarachnoid space. Some conditions influence its flow rate, such as the normal or pathological daily production of cerebrospinal fluid in the choroid plexuses of the lateral ventricles of the 3rd cerebral ventricle.

The noninvasive monitor will quantify the flow of cerebrospinal fluid in milliliters.

7) The second viable option for the development of the device, due to advances in the area of biotechnology, is photoemission spectroscopy (photo-emitter and photo-receiver) modality that includes laser doppler. In this case, laser spectroscopy is capable of tracking the perioptic subarachnoid space at the ocular level. In addition, laser doppler can penetrate body tissues up to the craniocerebral meninges among other anatomical structures.

8) Although laser Doppler is not ruled out for the functional development of the monitor, ultrasound is the first option, since it provides greater safety and security in all physiological tissue systems, including the gestational period in women and all pediatric stages of human development, as well as providing greater safety in the period related to old age. Consequently, ultrasound has been selected as the first alternative for the functionality of the noninvasive cerebrospinal fluid monitor.

PRESSURE WAVE GRAPH ON NON-INVASIVE CEREBROSPINAL FLUID MONITOR

9) The non-invasive cerebrospinal fluid monitor will display the results both in numerical figures of pressure (mm H20), in milliliters (its flow rate) and on a graphic screen; the latter, by showing the wave of its own pressure. The constant movement of the cerebrospinal fluid throughout its path and its passage through various anatomical structures with different diameters and lengths, from its ultrafiltration and production by the lateral ventricles of the 3rd cerebral ventricle to its final journey in the spinal cord through the foramina of Luschka and Magendie, and the cerebral obex; provide the CSF (cerebrospinal fluid) with an important part of its circulatory activity represented by its speed, flow rate and pressure. Although the subarachnoid space is similar to the venous system, anatomically there is no proven pulsatility to date, but under normal conditions there is an active flow exclusively at the expense of the cerebrospinal fluid, which exerts a direct force on the internal structures and membranes that make up the subarachnoid space, a space through which it continuously circulates through a complex system of partitions, trabeculae, cisterns and foramina. The contractility and pumping of the left ventricle of the heart plus the cerebral arterial pressure system are key factors that also participate in the circulatory mechanism of the cerebrospinal fluid. Plasma filtration by the choroid plexuses and therefore the production of cerebrospinal fluid also depends on a differential pressure mechanism at the cerebral arteriolar level among other metabolic factors. Therefore, and in a general sense, the circulation of cerebrospinal fluid is not static and therefore, it does not remain immobile, stagnant or adynamic, merely occupying a space, but its dynamics are kept in constant movement, exerting a certain degree of friction, force or pressure on the structures through which it moves. In this regard, it is conceived to design a graph on the monitor that shows the pressure wave or force of the cerebrospinal fluid as a result of its active circulation when traveling through the cerebral subarachnoid space and continuing its dynamism through the internal meningeal structures of the spinal cord. The importance of developing graphic vectors as results of the tension of the cerebrospinal fluid and its noninvasive quantification would be to analyze the patterns, behaviors or tensional splittings of the cerebrospinal fluid in the face of different pathological entities that occur with subarachnoid hemorrhages, thrombotic stroke, cerebral edema, among other pathologies. In addition, the dynamics of cerebrospinal fluid would be evaluated in different general anesthetic procedures including conductive spinal anesthesia.

MONITORING AT THE OPTIC NERVE LEVEL

10) Regarding the approach for noninvasive measurement of cerebrospinal fluid pressure, it can be quantified through the perioptic subarachnoid space, a space that surrounds the entire path of the optic nerve. Thus, and due to the short length of the optic nerve, monitoring can be done through any of its sections, either through the intraocular segment, its continuity in its path through the intraorbital portion or its canalicular segment including the optic chiasma. The noninvasive monitor can analyze the cerebrospinal fluid tension of both the right and left optic nerve by being able to track the subarachnoid space in a given section within its total meningeal length of approximately 4 to 5 cm.

MEDICAL APPLICATIONS OF NON-INVASIVE CEREBROSPINAL FLUID MONITORING

11) The applications of the monitor in medicine would be: in procedures related to neuroanesthesia and neurosurgery with the objective of continuously monitoring the CSF (cerebrospinal fluid) pressure figures both during and after surgery.

12) Continuous noninvasive monitoring of cerebrospinal fluid pressure levels for the purpose of maintaining close clinical surveillance in patients being treated for intracranial hypertension due to tumoral, neurotraumatic causes and neurological pathologies related to intracranial hypertension.

13) In addition to other clinical and diagnostic parameters, the noninvasive monitor can corroborate the clinical existence of intracranial hypertension.

14) To assess the flow rate in milliliters of cerebrospinal fluid and to detect a decrease in the same due to leakage through the spinal meninges as a consequence of procedures such as: lumbar puncture, epidural spinal anesthesia and traumatic subarachnoid spinal anesthetic blocks. Also, it will be possible to quantify the restoration of normal levels of cerebrospinal fluid (its normal total volume being 100 to 150 milliliters in adults) after spinal anesthetic procedures and treatment related to Spinal Blood Patch for the treatment of post-lumbar puncture headache.

15) Prospective analysis and studies on pathologies that present with dynamic dysfunction or abnormal production of cerebrospinal fluid. Also, in neuropharmacology, for example, drugs that could induce alterations in intracranial pressure at the expense of cerebrospinal fluid dynamics.

16) Monitoring instruments for evaluations in patients related to critical medicine or intensive care units.

17) Initial baseline monitoring of cerebrospinal fluid pressure and flow in patients admitted to hospitals via emergency services due to trauma or neurological injuries with the aim of creating a history or evolutionary pattern of these parameters from the time of admission, stay and discharge from the health center.

18) The device will also be able to assess differential cerebrospinal fluid pressure levels between the subarachnoid segments of the brain and the spinal cord neuroaxis.

ACCESSES RELATED TO MONITORING USING THE NON-INVASIVE CEREBROSPINAL FLUID MONITOR

19) Conventional transcranial ultrasound windows will serve as reference points, since by placing electrodes or noninvasive digital sensors in these windows it will be possible to address and quantify the pressure and flow of cerebrospinal fluid in both adults and pediatrics. These ultrasound windows related specifically to this noninvasive monitor are:

❖ Transtemporal and temporoparietal windows

❖ Transorbital

❖ Frontoparietal region

❖ Sub-occipital

❖ Spinal: in the case of patients with cranial deformity and active bleeding due to severe head trauma including trauma to the base of the skull and as a consequence preventing the placement of electrodes or the approach in this area, therefore, monitoring may be chosen through the subarachnoid space at the level of the spinal cord, the lumbar space being the most suitable anatomical topographic area. Also, the cervical, thoracic or dorsal routes in the spinal neuraxis are feasible for monitoring, in case there is a contraindication due to injuries in the lumbar area.

20) The noninvasive monitor can assess the pressure and flow of the cerebrospinal fluid in the patient in three ways, these approaches being:

21) Using electrodes connected from the monitor wiring system to the anatomical-topographic surfaces of the patient.

22) Digitally, without direct contact or wiring, this device will send a remote signal to a transmitter - receiver placed in an anatomical topographic area to be monitored.

23) Digital only (no wiring or electrodes) by directing the ultrasonic beams (emitter and receiver) and/or the laser spectroscopy source from the non-invasive monitor to the anatomical topographic area to be monitored.

Functions of the Multifunctional Support Base

24) The main function of this accessory piece is to serve as a support for the noninvasive cerebrospinal fluid monitor, but this piece will also be multifunctional as it can hold both the monitor and ultrasound transducers in procedures related to the area of ultrasound-guided anesthesiology, including intravascular access using ultrasound.

25) Some of these bases, supports or holders for ultrasound transducers were registered in a brief and partial manner at the National Copyright Office (ONDA), Dominican Republic; in the form of a medical essay, an essay that has not yet been published.

26) In the same order, another function of this multifunctional support base is to correctly modify the current hands-free technique in interventional anesthetic procedures using ultrasound, since it can hold the ultrasound transducers in anesthetic procedures using ultrasound, in addition to the monitor itself. The hands-free technique (currently used technique) consists of holding the ultrasound transducer with one hand while the ultrasound-guided procedure is performed with the other free hand. This technique is described in the text: Louis L.J. Musculoskeletal Ultrasound Intervention: Principles and Advances. Radiol Clin N Am. 2008; 46:5-533.

27) Another academic example in which the free-hand technique is described is in the medical article entitled: Ultrasound-guided interventions: what every radiologist should know. This interesting and complete medical article is authored by doctors: J.L. Del Cura, R. Zabalaa and I. Cortaa; from the Radiodiagnosis Service, Basurto Hospital, Bilbao, Spain, and the Department of Radiology, Surgery and Physical Medicine, University of the Basque Country - Euskalherriko Unibertsitatea, Donostia-San Sebastián, Spain.

28) Specifically and related to the area of interventional anesthesiology using ultrasound, the hands-free technique is also detailed in different anesthetic procedures on the channels and videos of the prestigious website www youtube.com in the following links:

❖ Ultrasound-Guided Femoral Nerve Block by NYSORA Continuing Medical Education

❖ Common Upper Extremity Blocks through ultrasound by University of Kentucky Department of Anesthesiology (Matthew Baker M.D.)

❖ Continuous Caudal Block Guided by Dr. Vicente Roques Escolar ❖ Sciatic Nerve Block by Dr. David Auyong, MD (anesthesiologist) SonoSite FUJIFILM Spain

❖ Ultrasound-Guided Transcaudal Spinal Block by Dr. Vicente Roques Escolar

❖ ASPUARD ultrasound-guided brachial plexus block

❖ Ultrasound-Guided Supraclavicular Brachial Plexus Block by NYSORA Continuing Medical Education

❖ Ultrasound Guidance for Central Venous Access - Part 1 and 2 - SonoSite, Inc.

❖ Ultrasound Guided Subclavian Central Lines -- BAVLS American Thoracic Society (2018)

❖ NYSORA - Regional Anesthesia Ultrasound-Guided Continuous Interscalene Brachial Plexus Block

29) In this aspect, the function of the multifunctional support base will be to hold the ultrasound transducer in a predetermined anatomical topographic area selected by the person performing the interventional procedure. In this way, the support base will allow the anesthesiology staff to have both hands truly free and available to perform the ultrasound-guided anesthetic approach while the ultrasound transducer rests on this support piece.

30) This multifunctional base will be designed at its distal and terminal end with a mobile head on which the ultrasound transducer and/or the noninvasive monitor will be placed and adjusted. This mobile head of the support arm will allow 360-degree movements both clockwise and counterclockwise, having the capacity to allow movements in all directions including diagonal turns forward and backward, or to be able to rotate and move on its own mobile central axis towards any topographic-anatomical point.

31) The multifunctional base can be in two ways:

32) Simple multifunctional support base (without power supply) and,

33) Base with double screen: in this mode, the monitored cerebrospinal fluid values will be reflected on its cross-piece from the monitor via a wireless connection. In this case, this cross-piece of the multifunctional support base will have an additional integrated screen which will receive the results corresponding to the assessment of the cerebrospinal fluid from the monitor.

TECHNOLOGICAL DETAILS AND DESIGNS RELATED TO THE NON-INVASIVE CEREBROSPINAL FLUID MONITOR AND MULTIFUNCTIONAL SUPPORT BASE

34) Due mainly to the different anatomical pathways that exist and are necessary to analyze cerebrospinal fluid, the electrodes of the noninvasive device will be designed according to the anatomical topographic area to be evaluated. For this reason, some monitor and electrode designs may be:

35) Eye patch type electrodes made of foam and silicone lined with moist gel (pediatric and adults) to be placed at the level of the eyeball, eye mask and virtual ocular glasses with ultrasound and/or mixed technologies with laser Doppler to be placed in both the right and left ocular area, pediatric ultrasonic headband with integrated screen in order to position it over the parietotemporal area, disposable electrodes type contact lenses. Spinal electrodes made of foam and silicone with moist gel to be connected by cables from the monitor to the spine.

36) The operational system and internal functional circuit of the noninvasive cerebrospinal fluid monitor may be integrated with any other monitor in the area of anesthesiology.

37) All monitors shall have rechargeable power systems, micro and standard USB ports, battery charge indicator and output for printing CSF flow and pressure figures. The device wiring may be unfolded and coiled within its own compartment or monitor housing. Portable monitors shall be fitted into their own base, which shall serve as an electrical recharger of the battery.

38) The ultrasonic frequencies of the monitor will range from 2, 5, 8 to more than 20 MHz, although during the manufacturing process other ranges or MHz different from those described above may be chosen. These will be in accordance with the various anatomical areas (superficial or deep) to be monitored, therefore being a multi-frequency ultrasound monitor.

39) Correctly, the first generation of noninvasive monitors can be designed showing only the quantification of the flow and pressure of the cerebrospinal fluid (without the pressure graph).

40) The multifunctional double-screen support base may be located in the front area of the anesthesiology service, and may be compatible with other anesthesiology monitors and reflect the other anesthesiology monitoring parameters on its cross-piece and drop-down screen. This drop-down screen may be designed in any dimension or size to facilitate its readability. One of the advantages of this modality would be that the monitored medical parameters would be supervised in front (in view) of the anesthesiology service throughout the anesthetic surgical procedure and not in the back (back area) or side of the anesthesiologists as is currently the custom.

41) The multifunctional support base will be placed on the side rail of the surgical stretcher, and may also be located and designed on a mobile pedestal base with wheels, which will be in contact with the floor, allowing it to be moved from one operating room to another. This multifunctional support base will also have supports for extensions and anesthetic infusions.

42) The non-invasive cerebrospinal fluid monitor will have a backlit LED/LCD graphic display with a multilingual menu and a memory capacity of 100 to 250 measurements, recording the date and time at the time of activation. It will also have an alarm indicating abnormal blood pressure values. The figures and results of the non-invasive monitor can also be reviewed remotely (Wi-Fi - Bluetooth).

43) The non-invasive monitor will allow time intervals to be selected and in this way it will be possible to program how often (seconds, minutes and hours) the device would automatically proceed to quantify the cerebrospinal fluid.

44) This noninvasive device will measure cerebrospinal fluid pressure in mm H20, but can also convert the results to mmHg, Torr, Pascal, Kpa, atm (atmosphere), mbar, Bar, PSi.

45) A rear anchor on the back of the monitor housing (support pin) will allow the device to be attached to vertical surfaces or perpendicular to the floor.

46) The noninvasive cerebrospinal fluid monitor may be designed in different shapes or models, dimensions and/or sizes; thus maintaining the purpose of its function (quantifying the flow and tension of the cerebrospinal fluid). For example, there is in the present textual content a model of a portable wireless pen-type monitor with the objective of being used at an optical level for noninvasive recording of the cerebrospinal fluid in emergency areas or in the medical office. In this regard, another different design will be adjusted in the retroauricular region (ears) for transcranial cerebrospinal fluid monitoring due to the anatomy and relationship of the inner ear, through which the cochlear aqueduct connects the bony labyrinth (filled with perilymph) with the subarachnoid space corresponding to the craniocerebral meninges.

As a complement to certain items of the above, the following is added:

Regarding item 0, the device will have 4 images or icons that represent the anatomical regions through which it will be possible to approach the subarachnoid space. These images on the monitor are: eyeball (second cranial nerve), auricle (space between the inner ear and the cerebral meninges), spinal column (spinal cord) and brain (lateral ventricle). By selecting and pressing one of these images, the monitor will start an automated scan of the subarachnoid space according to the selected icon, displaying on its screen the clinical parameters related to the pressure, flow rate and pressure waves of the cerebrospinal fluid.

In general, the device will consist of a module and an integrated electronic circuit, the basic components of which are: Micro Amplifier plus electronic noise filters, band pass filters, a separator for the flow direction of the cerebrospinal fluid, integrated microcontroller and microprocessor which will be programmed to execute and interpret all the functions of the device, backlit graphic and numerical display, bidirectional Doppler processor system of the subarachnoid space, quartz or ceramic crystal oscillators to emit and receive low and high frequency ultrasonic pulses, transducers, active laser medium generating near-infrared photons (in the case of the laser spectroscopic monitor) and finally ultrasonic and laser application software including digital spectrograms for the graphic representation of the pressure waves of the cerebrospinal fluid, and also to analyze, process and verify the dynamic pressure of the subarachnoid space due to sensors for detecting the density of the cerebrospinal fluid content.

Regarding item 1, indicate that the monitor will be capable of continuously monitoring, in real time and in a non-invasive manner, the dynamic tension, pressure waves and flow rate of the cerebrospinal fluid in the cerebral and ocular subarachnoid space and at the level of the spinal cord; expressing on the screen the results of pressure in mm H2O, the pressure waves in the digital spectrogram and the flow rate in milliliters per minute respectively.

An integrated system of non-invasive detectors will reliably confirm each scanned parameter. Within these detectors, there is an image sensor plus image recognition memory related to artificial intelligence, which will have the function of capturing, archiving, comparing and recognizing high-resolution images of the different areas to be evaluated in the subarachnoid space by the device. In this regard, the monitor will be able to store in its micro memory the morphological images of the meninges of each scanned subarachnoid space, from its initial condition to its final submission, and through plugins and an output assistant integrated into the circuit of the monitor, it will be possible to examine the scanned images using PCs, computers, mobile phones; both by direct connection from the non-invasive cerebrospinal fluid monitor and also wirelessly or telematically.

Regarding item 4, it should be noted that, with regard to the use of laser Doppler, Laser Doppler will be of near-infrared spectrometry. In this regard, two different models of invasive monitor will be developed first, the first will be developed using the ultrasound technique, the second device will be based on near-infrared spectrometry.

The reasons for building the device with two different hardware are related to its biophysical properties in medicine, since both ultrasound and near-infrared laser spectrometry are noninvasive.

Furthermore, it should be noted that other common characteristics are that both medical technologies (ultrasound and near-infrared spectrometry) are non-ionizing techniques, which do not emit radioactivity. Therefore, when developing the noninvasive device with both different techniques separately, the same purposes related to the real-time quantification of the pressure, flow rate and pressure wave of the cerebrospinal fluid will be pursued. For this reason, between the two technologies, the one that shows greater fidelity, medical precision and advantages in the aspect of noninvasive neuro-monitoring of the cerebrospinal fluid through this device will be evaluated.

Regarding item 5, indicate that the device will consist of an ultrasonic transmitter and receiver that will provide the Doppler effect and spectrum by emitting ultrasonic pulses to the subarachnoid space and general circulation of the cerebrospinal fluid.

The monitor will have the ability to discriminate between ultrasound interfaces originating from non-target anatomical areas or areas that are not relevant to the analysis in question; for example, the device will reject echo reception originating from blood vessels, anatomical structures occupying the anterior chamber of the eye (cornea, iris, lens, etc.) in the eyeball, and also from the epidural or peridural space in the spinal cord area, since cerebrospinal fluid does not circulate through these anatomical areas. This ultrasonic discrimination is based on the interpretation capacity of the device's microprocessor to recognize the return time in echo emission-reception when the ultrasound passes through the different anatomical interfaces from the skin surface to the subarachnoid space to be evaluated, in addition to the echogenic characteristics of each one of them.

The quantification of cerebrospinal fluid will be carried out in different sections of the subarachnoid space continuously and in real time, both at the level of the lateral ventricle of the brain, the second cranial nerve and the spinal cord. The mechanism will consist of quantifying the tension by evaluating the collisions and force exerted between the arachnoid meninges and the pia mater by the cellular and molecular set that make up the entire cerebrospinal fluid or a representative fraction of it on a given area in the subarachnoid space, in such a way, the noninvasive monitor will quantify the kinetics or pressure of the cerebrospinal fluid.

The mechanisms by which the noninvasive device will interpret the hydrodynamics of pressure, flow and graphic pressure waves of the cerebrospinal fluid will be:

a) Processing of the echo reception from the patient using an ultrasound application program (software) which will analyze and calculate the distances, intensities and times of the echoes received from the patient under physiological conditions as well as in circumstances where there are pathological ultrasound patterns concerning the pressure and flow of the cerebrospinal fluid.

b) A set of ultrasonic micro sensors for both pressure and density detection will capture changes in the density of the cerebrospinal fluid, identifying any pathological variants that occur with abnormal densities of the cerebrospinal fluid, such as, for example, subarachnoid hemorrhage. The monitor, using an application of algorithms in the program of the microcontroller and microprocessor of the device, will be able to perform calculations based on the characteristics and patterns of normal and pathological echogenicity of the cerebrospinal fluid, both in terms of density and pressure, with the device recognizing in its memory the normal reference for both parameters, which range between 1003 g/ml - 1010 g/ml (density) and 70 to 200 mmH2O in pressure.

c) Therefore, the noninvasive device will also interpret and calculate the changes in echogenic impedance related to abnormal changes in pressure, velocity and flow rate of the cerebrospinal fluid, displaying on its screen the results according to the clinical condition of the patient. Therefore, the monitor will be able to capture in its scan any increase in ultrasonic impedance due to abnormal cellular increase in the content of the cerebrospinal fluid. The most important pathological causes of the increase in density plus concomitant increase in the pathophysiological cellular content are: hemorrhagic stroke, neurotrauma, infectious diseases, neoplasia, among other conditions.

The imperative reason why this device will determine the density of the cerebrospinal fluid in the subarachnoid space is because the dynamic pressure is determined by the density of a fluid, in this specific case the cerebrospinal fluid, divided by the velocity per m/s of the fluid in question. For this reason, the device will have an integrated ultrasonic density sensor in order to truthfully confirm the ultrasonic impedance coming from the subarachnoid space under any pathological condition. Dynamic pressure is often expressed in Pascals, although the device will display the results in mm H2O based on the assumption that 1 mmH2O = 9.80665 pascals (Pa) or, 1 mm H2O = 9.8 pascals (Pa).

In this aspect, the microprocessor unit integrated into the device's equipment will be able to calculate, using its algorithm, the figures corresponding to the cerebrospinal fluid tension, expressing the results in mm H2O.

Regarding item 6, it should be noted that, in terms of volume, the device will noninvasively assess the flow rate of cerebrospinal fluid, determining the volume circulating in real time through a given segment of the subarachnoid space per unit of time, which will be quantified in milliliters per second and/or minute. In this regard, cerebrospinal fluid circulates under normal conditions and in adults at a speed of 20 ml per minute, a parameter taken as a normal reference by the device to calculate its transit at the cranial-spinal level. At the perioptic level of the second cranial nerve, the subarachnoid space contains an approximate volume of 0.1 ml of cerebrospinal fluid.

In this regard, the volumes to be determined are those that circulate at the level of the cerebral subarachnoid space, perioptic space and spinal cord. These volumes will be quantified based on the flow or Doppler effect by evaluating the difference between the ultrasonic times of flows in the direction of the circulatory current through which the cerebrospinal fluid travels or against the current or circulation, this in turn will depend on the speed of the flow of the cerebrospinal fluid in the subarachnoid space. Due to the bidirectional Doppler processor system of this noninvasive device, the direction of flow of the dynamic circulation can be detected mainly in the spinal cord. Physiologically, the flow of CSF alternates the direction of its circulation in a caudal direction with a cephalic direction. The main circulatory flow is in a cranial-caudal direction and the cephalic reflux is produced by turbulence. In the spinal cord there is a continuous bidirectional flow which consists of a caudal direction on the dorsal surface and a cephalic direction on the anterior or ventral surface; which will be processed by the monitor's bidirectional Doppler system. Quantification of flow and pressure at the spinal cord level in adults will be performed through transcutaneous electrodes which will be connected by a micro-wiring system to the non-invasive device. This connection will emit ultrasonic pulses to the spinal region to be scanned, since a selector and filter of ultrasonic bands inside the device will be automatically activated when the monitor operator chooses the anatomical approach to be scanned. The spinal cutaneous electrodes will preferably be placed between the L3 - L4 or L4 - L5 interspaces, taking the Tuffier line as an anatomical reference. Once positioned in this region, the monitor will automatically use an ultrasound frequency between 1 and 5 MHz in order to identify the subarachnoid space and the cerebrospinal fluid. In contrast, in pediatrics the device will use a high frequency between 7 and 12 MHz because the distance in the antero-posterior plane or between the skin and the subarachnoid space is smaller and more superficial than in adults due to the process of biological development or growth in pediatrics.

Regarding item 7, it should be noted that laser spectroscopy is capable of tracking the perioptic subarachnoid space at the ocular, spinal cord and cerebral levels.

Regarding item 8, it should be noted that, in relation to the previous aspect, two types of monitors will be developed with different technologies. The first, as explained, will be carried out using ultrasound, since they would provide greater safety and security in all physiological tissue systems, including the gestational period in women and all pediatric stages in human development, in addition to providing greater safety in the period related to old age.

In contrast, the second device will be built using near-infrared photons (spectroscopy) with the purpose of establishing a multi-center medical protocol to determine the disadvantages and benefits related to neuromonitoring between both medical technologies.

The mechanism by which the noninvasive monitor would quantify the pressure and flow of the cerebrospinal fluid through the photoemission and photoreception of near-infrared photons is based on:

The present device will use two transcutaneous sensors where each sensor will consist of a light emitting source with two different types of wavelengths and two photodetectors. Regarding the two photodetectors, the one closest to the light emitter will measure the most superficial tissue layers (not the target tissue or cerebrospinal fluid) and the furthest photodetector combined with the device's optical density and pressure sensor will scan the subarachnoid space and the cerebrospinal fluid, providing pressure and flow results due to the difference in photonic absorption between the light emitted in nanometers and that absorbed by the cerebrospinal fluid. For this reason, the mechanism by which the device would work is the following:

❖ The interaction of the monitor with the proteins contained in the cerebrospinal fluid, since these proteins also have two types of chromophores in their structure, biochemical components capable of interacting with the photoemission of photons, the peptide bond itself, inherent to the formation of a polypeptide chain, and the side chains of its aromatic amino acids. The total value of the proteins that normally make up the cerebrospinal fluid is: 15 to 60 mg/dl. In addition, the Myelin Basic Protein with a value < 1.5 ng/ml. The photons emitted by the photo-emitter will be dispersed in the tissue bed including the subarachnoid space and the cerebrospinal fluid; those that are not absorbed are returned to the transcutaneous photodetector placed on the skin. Then, the quantification of the device would represent the amount of light or photons absorbed by the cerebrospinal fluid.

❖ Under normal conditions there are no red blood cells in the cerebrospinal fluid, although in the case of subarachnoid hemorrhage or other hemorrhagic pathological entity in the subarachnoid space, the spectroscopic interaction by means of the device will be carried out with the hemoglobin (protein) of the red blood cell, producing as a consequence this pathological situation, greater absorption of the wavelength or photons emitted by the device compared to the normal absorption of photons related to the normal protein quantity that exists in the cerebrospinal fluid. In the case of infectious disease, the white blood cells that normally make up the cerebrospinal fluid will produce antibodies (immunoglobulins with protein chains) as a defense mechanism against infectious attacks, this will also trigger an increase in photon absorption which will be reflected in the photodetector of the device when capturing the photons that return to it.

In order to develop this device, the absorptions of different wavelengths will be tested in order to analyze the photons that pass through the various anatomical surfaces until they interact with the subarachnoid space and cerebrospinal fluid. The purpose is to accurately determine the type of wavelength (nm) and the differences between the uptake of photons in the different tissue compartments that also contain proteins and which are located more external and proximal between the cutaneous surface and the subarachnoid space, which is located deeper from the anteroposterior cutaneous plane. The device will quantify the radius of photonic absorption according to its wavelength. In this case, wavelengths ranging from 730 nm to 2,600 nm (nanometers) will be used. An integrated software application (spectroscopic) will analyze and calculate each parameter to be scanned, taking as a normal reference the index or ratio of photonic absorption in addition to the quantity of emitted beams that are not absorbed by the tissue compartments throughout the path to the subarachnoid space and cerebrospinal fluid. Patients with normal pressure and flow will be compared, in which the photo-emitted-received interaction is physiological, and will be compared with the photonic absorptions in pathological conditions that do alter the pressure and flow of the cerebrospinal fluid. Also, the photoreceptors, through an application program, will be able to discriminate wavelengths from non-target tissues.

❖ It has been determined that the normal amount of cerebrospinal fluid in adults ranges between 100 and 150 ml, with the main component being water due to plasma ultrafiltration. In medicine, certain photonic wavelengths interact with tissue water, for this reason, the flow rate of cerebrospinal fluid will be scanned using photosensors that emit wavelengths greater than 900 nm (nanometers) because they interact with organic tissue water.

Spectrograms related to cerebrospinal fluid pressure waves will be performed in real time together with programmable algorithms in the application software based on optical spectrophotometry.

Regarding item 9, it should be noted that in the dynamics of the cerebrospinal fluid, due to Bernoulli's principle, the fluid circulates continuously through a complex system of partitions, trabeculae, cisterns and foramina. Therefore, and in a general sense, the circulation of the cerebrospinal fluid is not static and therefore, it does not remain immobile, stagnant or adynamic, merely occupying a space, but its dynamics are kept in constant movement, exerting a certain degree of friction, force and pressure on the structures through which it moves. In this regard, it is conceived to design a graph on the monitor that shows the pressure wave as a result of its active circulation when traveling through the cerebral subarachnoid space and continuing its dynamics through the spinal cord.

The importance of developing graphic vectors using digital spectrograms on the device screen would be to analyze the patterns, behaviors or tension splittings of the cerebrospinal fluid in different pathological entities that occur with subarachnoid hemorrhages, thrombotic stroke, cerebral edema, among other pathologies. In addition, the dynamics of the cerebrospinal fluid by pulsatile waves in different general anesthetic procedures including conductive spinal anesthesia would be evaluated. Type A or plateau waves, B and C waves can be monitored, archived and recorded by this device. The digital spectrogram will be presented in real time on the high-resolution screen of the device using an algorithm based on a succession of Fourier Transforms.

Regarding item 10, please note that prior to approaching the eye with the non-invasive device, the eye function of the device will be selected, and the device will then use high-frequency ultrasound, which will range from 5 - 7.5 to 20 MHz. Scanning will begin when the device and its transducer or electrodes are placed in contact with the upper eyelid. In both cases, placement should be transverse over the naso-orbital skin portion of the upper eyelid (whether in the left or right eye). The device will then begin an automated scan of the ocular subarachnoid space using an integrated ultrasonic depth gauge, which will automatically measure the junction of the retina with the optic nerve first transversely and then perpendicularly towards the meningeal covers (classic standard technique at the eye level). This action will be assisted by the ultrasound beams of the echo transmitter-receiver (in the ultrasound device) with the objective of jointly tracking and identifying the area corresponding to the posterior ocular pole, the anatomical region where the papillary zone and the beginning of the optic nerve path and subarachnoid space are located. In this regard, the device will have three ways to identify the subarachnoid space and its content, the cerebrospinal fluid, which are:

• Through the times and echogenic characteristics due to the pulses of the echo emission - reception through the anatomical interfaces scanned by the device.

• Image sensor plus integrated image recognition program (artificial intelligent memory) which will allow recognition of the subarachnoid space and cerebrospinal fluid.

• The application program established in the microcontroller and microprocessor will be able to perform automated measurement by ultrasound and laser spectroscopy of the dilation of the meningeal lining due to intracranial hypertension at the level of the perioptic subarachnoid space of the second cranial nerve. This function can be analyzed from the noninvasive cerebrospinal fluid device using any computer or mobile device with a screen through the external auxiliary unit of the noninvasive cerebrospinal fluid monitor or telematically.

Regarding the medical applications of the noninvasive cerebrospinal fluid monitor, the functional application of this noninvasive device would be to maintain continuous and precise monitoring of intracranial pressure without causing additional risks of morbidity and mortality in patients due to the noninvasive approach. In this regard, different situations and pathological entities are briefly stated in which the noninvasive cerebrospinal fluid device would serve as guidance, monitoring and medical decision-making related to the continuous monitoring of pressure, flow rate (speed - quantity) and pulse waves of cerebrospinal fluid.

Regarding item 15, non-hemorrhagic subarachnoid pathologies and certain drugs administered intrathecally may also be monitored.

In general, the enumeration of medical applications of the device has been made with the intention of maintaining a schematic order as well as specifying the medical purpose for which the present device has been conceived.

Regarding item 19, in the case of access through transtemporal and temporo-parietal windows, it should be noted that, through the Transtemporal window (temporal scales), the lateral cerebral ventricle will be assessed following the current medical protocol, placing the sensors - electrodes in an axial plane with an oblique cut in this area to identify the third ventricle using the device's image recognition system. The third cerebral ventricle is the target to be scanned since it is occupied by cerebrospinal fluid.

Regarding item 22, it should be noted that, in the case of ocular scanning, eyelid tarsal microelectrodes will be prepared based on nanotechnology, which will contain an echo transmitter-receiver for the constant monitoring of the subarachnoid perioptic space at the level of the optic nerve. These electrodes will be placed in the tarsal skin area of the upper eyelid or in the eyelid fold, mainly in patients with Asian phenotypic features. A motion detector integrated into the device will verify the blinking times in order to analyze the parameters to be evaluated by the device when the patient is at any score corresponding to the ocular response of the Glasgow scale. The microelectrodes will send the scanned echo reception to the device via a wireless signal.

Regarding item 23, indicate that a directional or focused ultrasound system will be developed integrated into the monitor using the sonic modulation and amplification technique by which the ultrasounds emitted from the echo emitter will penetrate towards the corresponding anatomical topography area up to the subarachnoid space to be scanned without the need for wiring or electrodes, this methodology will follow the Huygens-Fresnel principle and the study of Francis Galton in 1876, the latter confirmed the stratification and focusing of sounds including the range of ultrasonic levels. In this case of monitoring without electrodes and for visual orientation, the skin surface to be scanned will be illuminated through a micro LED photodiode which will act as a point-like light indicator in the topographic area to be evaluated by the device.

In the case of near-infrared spectroscopy, the sensor or photoemitter and the two transcutaneous photoreceptors can be placed at a distance of 1 millimeter to 15 centimeters between the patient's skin surface and the noninvasive device.

Regarding item 34, it should be noted that transcutaneous sensors with emitters of two and three different types of wavelengths can also be used, each with its own photodetector (for laser devices).

DESCRIPTION OF FIGURES

Figure 1.- Shows a view of the device to quantify the flow and pressure of the Cerebrospinal Fluid in a noninvasive manner.

Figure 2.- Shows a view of the use of the monitor of the invention.

Figure 3.- Shows a variant of the portable Pen-type Wireless Monitor.

Figure 4.- shows a view of the placement of a sensor in a patient's eye.

Figure 04 (B).-Shows the quantification of cerebrospinal fluid at ocular level using a noninvasive portable monitor.

Figure 5.-Shows a simple configuration multifunctional support base.

Figure 6.-Shows a multifunctional support base with a double screen.

Figure 7.-Shows a multifunctional support base and its function as an ultrasound transducer support in anesthesiology.

Figure 8.-Shows a multifunctional support base holding the noninvasive cerebrospinal fluid monitor

DESCRIPTION EXAMPLE EMBODIMENT OF THE INVENTION

Starting with Figure 1, the following elements can be seen:

01) Monitor housing

02) Backlit display

03) Unit of measurement for pressure and flow

04) Graphical representation of the dynamics of the Cerebrospinal Fluid

05) Port for electric power

06) USB port

07) Output port for printing

08) Connector for wiring the device electrodes

09) Wireless remote signal transmitter of the device

10) Selector or button for measuring flow and pressure of cerebrospinal fluid

11) On/Off Button

12) Cerebrospinal Fluid (CSF) Text Indicator

13) Hand holder

14) Real-time numerical indicator of LCR figures

15) Remote and telematic signal from the device

16 and 17) Wireless electrode with ultrasonic transmitter - receiver respectively

18 and 19) Wiring and Electrode of the device

Figure 2 shows:

20 and 21) Device and monitor screen

22) Remote monitor signals

23) Spinal electrode of the device

24) Lumbar spinal region (L4 indicating reference point of the fourth lumbar vertebra and topographic area where electrodes are placed for monitoring). Spinal cord in blue.

25) Spine (cervical, thoracic, lumbar and sacro-coccygeal vertebrae, vertebral bodies and spinal canal. (Lateral view)

26) Pia mater (Longitudinal section of the meninges in the spinal cord at the level of L4 or fourth lumbar vertebra)

27) Subarachnoid space (Anatomical area to monitor)

28) Arachnoid

29) Dura mater

Figure 3 shows a variant of the Pen-type Portable Wireless Monitor, with:

30 and 31) Device screen

30 b) On/Off button

32) Microprocessor unit of the device

33) Ultrasonic transmitter and receiver

Figure 4 shows:

34 and 34 B) Electrode in ocular area

35) Vitreous humor

36) Optic Nerve

37) Optic subarachnoid space (Target to be monitored)

Figure 04 (B) shows the quantification of cerebrospinal fluid at ocular level using a noninvasive portable monitor.

Figure 5 shows a (simple) Multifunctional Support base with:

38 and 39) Connector for the non-invasive device and/or ultrasound transducer located at the distal end of the multifunctional support base with a displacement piece and rotations of movements in all directions including 360 degree angles.

40) Multifunctional support base cross piece

41) Circular piece for moving forward and backward.

42) Multifunctional support base rising piece

43) Base support piece (shows figure indicating that it allows 360 degree rotations clockwise and counterclockwise)

44) Removable connector, which allows the multifunctional support base to be connected to the surgical stretcher

Figure 6 shows a Multifunctional Support base with double screen, with:

45) Operating room stretcher

46 Operating room stretcher railings

47) Device (screen omitted)

48, 49, 51,52, 53, 54 and 55) Parts in common with the simple multifunctional support base

50) Dual screen (Screen Mirroring) on the cross piece of the support base. Its function is to receive the results from the monitor on your screen wirelessly.

50 (b) Extended dual screen (Screen Mirroring).

Figure 7 shows a multifunctional support base and its function as an ultrasound transducer support in anesthesiology, with:

56) Multifunctional support base connector holding an ultrasound transducer (image shows indicator of movements in all directions on its own central axis including 360 degree rotations to the right and left)

57) Double screen (Screen Mirroring) on the cross piece of the multifunctional support base through wireless connection to the non-invasive device.

58) Noninvasive device (screen omitted in this drawing)

59) Multifunctional base connector to the operating table (with 360-degree movement indicator with right and left turns and forward and backward movements of the support base on the surgical table).

A multifunctional support base holding the noninvasive cerebrospinal fluid monitor can be seen in Figure 8.

Claims (47)

1.- Non-invasive cerebrospinal fluid monitor characterized by comprising a monitor that includes sensors for continuous, real-time and non-invasive monitoring of at least one of the following parameters: -the pressure of the cerebrospinal fluid in the subarachnoid space of the brain, eyes and at the level of the spinal cord, and -the flow rate of cerebrospinal fluid; 2.- Non-invasive cerebrospinal fluid monitor according to claim 1, comprising a multifunctional support base, comprising a support for the monitor and supports for ultrasound transducers in anesthesiology. 3. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, where the sensors, software and ultrasonic application algorithms comprise sensors with ultrasonic densitometer effect and Doppler effect. 4. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, where the sensors comprise Doppler effect laser sensors. 5. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, where the sensors comprise sensors selected from: • modified intense pulsed light, • infrared variety or near-infrared spectroscopy, • micro ocular pressure techniques, • strain gauges, optical or other digital pressure sensors, and • combination of ultrasonic and laser sensors. 6. - Non-invasive cerebrospinal fluid monitor according to any of claims 3 to 5, where the Doppler effect sensors are associated with an integrated ultrasonic microcontroller and microprocessor to quantify the pressure of the cerebrospinal fluid by evaluating the collisions and force exerted between the arachnoid meninges and the pia mater by the cellular and molecular set that compose it in its entirety and to quantify the flow rate of the cerebrospinal fluid by evaluating the difference between the flow times in the direction of the circulatory current through which the cerebrospinal fluid travels or against the current or circulation by means of the Doppler flow, and also, to analyze, process and verify the dynamic pressure of the subarachnoid space due to sensors for detecting the density of the content of the cerebrospinal fluid. 7. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, comprising at least one graphic display. 8. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, comprising approaching through the perioptic subarachnoid space, by means of any of its sections, being able to track the subarachnoid space in a given section within its total meningeal length of approximately 4 to 5 cm. 9. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, which is used in procedures related to neuroanesthesia and neurosurgery with the aim of continuously monitoring the CSF (cerebrospinal fluid) pressure levels both during and after surgery. 10. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, used for the purpose of maintaining close clinical surveillance in patients being treated for intracranial hypertension due to tumoral, neurotraumatological causes and neurological pathologies related to intracranial hypertension. 11. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims that, together with other clinical and diagnostic parameters, corroborates the clinical existence of intracranial hypertension. 12. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, which is used to assess the flow rate in milliliters of cerebrospinal fluid and detect a decrease in it or its restoration to normal levels after procedures. 13. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, which is used as a monitoring instrument for evaluations in patients related to critical medicine or intensive care units. 14. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, used in initial baseline monitoring of cerebrospinal fluid pressure and flow in patients admitted to hospitals via emergency services. 15. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, used to assess differential pressure levels of the cerebrospinal fluid between the subarachnoid segments of the brain and the spinal cord neuroaxis. 16. - Noninvasive cerebrospinal fluid monitor according to any of the preceding claims that uses conventional transcranial ultrasonic windows as reference points for placement of noninvasive electrodes or sensors. 17. - Noninvasive cerebrospinal fluid monitor according to claim 16, where the transcranial ultrasonic windows comprise: • Transtemporal and temporo-parietal windows • Transorbital • Frontoparietal region • Sub-occipital • Spinal 18. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, comprising: • electrodes connected by wiring to the monitor, which can be placed on the patient's anatomical-topographic surfaces. • Transmitters-receivers placed in anatomical topographic areas to be monitored, wirelessly connected to the monitor • Ultrasonic emitters or laser spectroscopy sources integrated into the monitor capable of directing their beams to the anatomical topographic area to be monitored. 19. - Non-invasive cerebrospinal fluid monitor according to any of claims 2 to 18, where the multifunctional support base comprises a support for the monitor, and additional supports for ultrasound transducers in procedures related to the area of ultrasound-guided anesthesiology, including intravascular access by ultrasound. 20. - Non-invasive cerebrospinal fluid monitor according to any of claims 2 to 19, wherein the multifunctional support base comprises additional supports for the ultrasound transducer in a predetermined anatomical topographic area to allow the anesthesiology staff to have both hands free and available to perform the ultrasound-guided anesthetic approach while the ultrasound transducer rests on this support piece. 21. - Non-invasive cerebrospinal fluid monitor according to any of claims 2 to 20, where the multifunctional base comprises at its distal and terminal end a mobile head in which the ultrasound transducer and/or the non-invasive monitor are placed and adjusted. 22. - Non-invasive cerebrospinal fluid monitor according to claim 21, where the movable head of the support arm is movable in 360 degree movements both clockwise and counterclockwise. 23.- Non-invasive cerebrospinal fluid monitor according to any of claims 2 to 22, where the multifunctional support base is simple, without electrical power supply. 24.- Non-invasive cerebrospinal fluid monitor according to any of claims 2 to 22, where the multifunctional support base comprises a double screen, one of them representing the monitored figures of the cerebrospinal fluid on its cross piece coming from the monitor through a wireless connection, and an additional one representing the results corresponding to the assessment of the cerebrospinal fluid from the monitor, mounted on the cross piece of the multifunctional support base. 25. -Noninvasive cerebrospinal fluid monitor according to claim 24, where the multifunctional double-screen support base can be located in the front area of the anesthesiology service. 26. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, comprising electrodes designed according to the anatomical topographic area to be evaluated. 27. -Noninvasive cerebrospinal fluid monitor according to claim 26, where the electrodes are selected from: • foam and silicone eye patch electrodes lined with moist gel (pediatric and adult) to be placed at the level of the eyeball, • a mask and virtual ocular glasses with ultrasound and/or mixed technologies with Doppler laser to be placed on both the right and left ocular area, • a pediatric ultrasound headband with an integrated screen to be positioned over the parietotemporal area, • disposable electrodes like contact lenses. • foam and silicone spinal electrodes with moist gel to be connected by cables from the monitor to the spine. 28. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, where the operational system and internal functional circuit of the non-invasive cerebrospinal fluid monitor may be integrated into any other monitor in the area of anesthesiology. 29. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, comprising rechargeable power systems, micro port and standard USB port, battery charge indicator and output for printing results of the flow rate and pressure figures of the CSF (cerebrospinal fluid). 30. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, comprising winders for the wiring in its own compartment or housing. 31. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, which is materialized in a portable format comprising battery recharging connections that can be attached to its base. 32. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims comprising ultrasonic frequencies ranging from 2, 5, 8 to more than 20 MHz 33. --Noninvasive cerebrospinal fluid monitor according to any of claims 2 to 32, wherein the multifunctional support base comprises: -anchors for the side rail of the surgical stretcher, -a mobile pedestal base with wheels, which will be in contact with the ground 34. - Non-invasive cerebrospinal fluid monitor according to any of claims 2 to 33, where the multifunctional support base will also have supports for extensions and anesthetic infusions. 35. - Non-invasive cerebrospinal fluid monitor according to any of claims 7 to 34, where the screens comprise backlit LED/LCD graphic screens with a multilingual menu and memory capacity from 100 to 250 measurements, including an alarm indicating abnormal blood pressure figures and telematic connection. 36. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, comprising a time interval selector. 37. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, comprising a cerebrospinal fluid pressure unit converter. 38. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, comprising a rear anchorage in the rear part of its casing. 39. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, comprising different shapes or models, dimensions and/or sizes. 40. -Noninvasive cerebrospinal fluid monitor according to claim 1, comprising a wireless portable pen-type format. 41.-Noninvasive cerebrospinal fluid monitor according to claim 1, comprising a portable format adjusted to the retroauricular region. 42.- Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, comprising an application program and algorithms for the assessment of photonic absorption and interpretation of the normal and abnormal protein content of the subarachnoid space by means of near-infrared spectrometry and its direct relationship with the pressure and flow dynamics of the cerebrospinal fluid. 43.- Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, comprising an application program and algorithms for the assessment and interpretation of the aqueous content of the cerebrospinal fluid and its flow rate, using near-infrared spectrometry. 44.- Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, comprising an application program and algorithms for automatically selecting photonic beams measured in nanometers capable of penetrating, studying and tracking the subarachnoid space and its content, the cerebrospinal fluid. 45.- Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, comprising a memory and artificial intelligence for the recognition of physiological, morphological and pathological images of the subarachnoid space, the latter due to conditions of intracranial hypertension. 46. - Non-invasive cerebrospinal fluid monitor according to any of the preceding claims, comprising an image recognition memory for the automated detection and identification of the subarachnoid space at the periocular, cerebral and spinal cord levels by the device. 47. - Intracranial pressure measurement procedure characterized by the measurement of the pressure and dynamics of the cerebrospinal fluid in the subarachnoid space using noninvasive sensors selected from: • Modified intense pulsed light sensors • Infrared range sensors or near-infrared spectroscopy, • Laser Doppler sensors, • micro ocular pressure techniques, • strain gauges, optical or other digital pressure sensors, and • combination of ultrasonic and laser sensors.