ES2975667B2 - Non-invasive cerebrospinal fluid monitor and intracranial pressure measurement procedure - Google Patents

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 the monitoring of current intracranial pressure. 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 intracranial pressure monitoring report published online on the prestigious MedlinePlus website (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 methods for measuring intracranial pressure, according to the MedlinePlus article (Intracranial Pressure Monitoring). These methods are performed by inserting invasive intracerebral sensors, which include:

a) Intraventricular catheter (more 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 the intracerebral cerebrospinal fluid.

Another way to measure intracranial pressure by assessing cerebrospinal fluid is through a spinal lumbar puncture. A spinal catheter is then invasively inserted to obtain cerebrospinal fluid pressure, as described in the online medical article titled: Lumbar Puncture and Cerebrospinal Fluid Measurement, written by physicians Alfonso Verdú and María Rosario Cazorla of the Pediatric Neurology Department at Gregorio Marañón Hospital, Madrid, Spain, and the Neuropediatrics Unit at Virgen de la Salud Hospital, Toledo, Spain.

In this same aspect and currently, ICP (intracranial pressure) is also assessed indirectly and non-invasively through the thickness and diameter of the optic nerve sheath using ocular ultrasound (a NOVD or Normal Optic Nerve Sheath Diameter is considered when it has a length of 3-4.9 mm). In this sense, the diameter of the sheath that covers the optic nerve at the intraocular level (NOVD) is specifically and only measured by ultrasound.

Another method for assessing 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 a separate study related to the qualitative aspects of certain specific components of cerebrospinal fluid in newborns, a team of three Spanish scientists and one British scientist—Javier Jiménez, Carlos Castro, Berta Martí, and Ian Butterworth—developed a device that allows for the diagnosis of bacterial meningitis in newborns using high-resolution ultrasound through the cranial fontanelles. These scientists successfully evaluated the device in newborns for the purpose of diagnosing meningitis at La Paz University Hospital in Madrid, Spain.

Other advances include Smart Contact 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 visualization, taking photos and videos.

Another study, different from the approach to measuring intracranial pressure, is being conducted in Vilnius, Lithuania, led by neurosurgeon Dr. Saulius Rocka. In this regard, the team of scientists in Lithuania is calculating blood flow parameters in two different regions of the ophthalmic artery using ocular vascular ultrasound to determine intracranial pressure.

DESCRIPTION OF THE DEVICE

0) It consists of a medical device that noninvasively monitors cerebrospinal fluid. This monitor will be accompanied by an accessory device or multifunctional support base.

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

1) The monitor will be able to continuously monitor cerebrospinal fluid pressure in real time and noninvasively, using ultrasound as the first-line technology. The device will determine the force exerted by this fluid in the subarachnoid space of the brain, the eye, and the spinal cord. In addition, the noninvasive monitor will be able to quantify cerebrospinal fluid flow in milliliters.

2) Regarding the multifunctional support base, this will be an accessory and is primarily designed to hold the noninvasive cerebrospinal fluid monitor. Furthermore, this multifunctional support base will be able to successfully modify the hands-free technique in ultrasound anesthesia procedures, as it will be designed to hold both the noninvasive monitor and the ultrasound transducers used in anesthesiology.

TECHNOLOGIES IN MEDICINE AND DEVELOPMENT OF THE NON-INVASIVE CEREBROSPINAL FLUID MONITOR

Regarding the development and functionality of the non-invasive cerebrospinal fluid monitor, two types of medical technologies have been selected:

3) First-line 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 track the meningeal coverings, including the interior of the subarachnoid space (the space between the arachnoid meninges and the pia mater), compartments through which cerebrospinal fluid dynamically circulates.

In this regard, there are other technologies that would enter the prototyping stage of the noninvasive cerebrospinal fluid monitor after the two selected medical alternatives (ultrasound and lasers) have been exhausted. Some of these other medical technologies include: intense pulsed light modified for this case, a variety of infrared, ocular micropressure 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 THE 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 cerebrospinal fluid circulation. This mechanism will scan the flow rate, velocity, and pressure of the cerebrospinal fluid. Cerebrospinal fluid will be quantified in different sections of the subarachnoid space continuously and in real time, at the level of the brain, the second cranial nerve, and the spinal cord. The mechanism will consist of quantifying tension by evaluating the collisions and force exerted between the arachnoid meninges and the pia mater by the cellular and molecular complex that makes up the entire cerebrospinal fluid, or a representative fraction thereof, on a specific area within the subarachnoid space. In this way, the noninvasive monitor will quantify the kinetics or pressure of the cerebrospinal fluid. An ultrasonic microprocessor unit integrated into the device's equipment will be able to assess the figures corresponding to the cerebrospinal fluid tension, expressing the results in mm H20.

6) In that order, the cerebrospinal fluid flow rate will be quantified based on Doppler flow, by evaluating the difference between the flow times in the direction of the circulatory current through which the cerebrospinal fluid transits or against the current or circulation, this in turn, will depend on the speed of the cerebrospinal fluid flow 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 rate of cerebrospinal fluid in milliliters.

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

8) Although laser Doppler is not ruled out for the functional development of the monitor, ultrasound is the first option, as it provides greater safety and security in all physiological tissue systems, including the gestational period in women and all pediatric stages of human development. It also provides greater safety during the elderly period. Therefore, ultrasound has been selected as the first alternative for the functionality of the noninvasive cerebrospinal fluid monitor.

PRESSURE WAVE GRAPH ON THE 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 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 similar to the venous system, anatomically speaking, the subarachnoid space has no proven pulsatility. However, under normal conditions, active flow exists exclusively through cerebrospinal fluid, which exerts 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 septa, trabeculae, cisterns, and foramina. The contractility and pumping of the left ventricle of the heart, along with the cerebral arterial pressure system, are key factors that also participate in the cerebrospinal fluid circulation. 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, in a general sense, cerebrospinal fluid circulation is not static, and therefore, it does not remain motionless, stagnant, or adynamic, merely occupying a space. Rather, its dynamics remain in constant motion, exerting a certain degree of friction, force, or pressure on the structures through which it moves. In this regard, a graphic is designed on the monitor that shows the pressure wave or force of the cerebrospinal fluid as a result of its active circulation as it travels through the cerebral subarachnoid space and continues its dynamism through the internal meningeal structures of the spinal cord. The importance of developing graphic vectors as results of cerebrospinal fluid tension and its noninvasive quantification would be to analyze the patterns, behaviors, or tensional unfoldings of the cerebrospinal fluid in the face of different pathological entities that present with subarachnoid hemorrhages, thrombotic stroke, cerebral edema, among other pathologies. In addition, the dynamism of cerebrospinal fluid would be evaluated in different general anesthetic procedures, including conductive spinal anesthesia.

OPTIC NERVE LEVEL MONITORING

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

MEDICAL APPLICATIONS OF THE NON-INVASIVE CEREBROSPINAL FLUID MONITOR

11) The medical applications of the monitor 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 non-invasive monitoring of cerebrospinal fluid pressure levels for the purpose of maintaining close clinical surveillance in patients being treated for intracranial hypertension due to tumor causes, neurotraumatological causes, and neurological pathologies related to intracranial hypertension.

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

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

15) Analysis and prospective studies on pathologies that present with dynamic dysfunction or abnormal cerebrospinal fluid production. 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 rate in patients admitted to hospitals via emergency due to traumatic or neurological injuries with the objective of creating a history or evolutionary pattern of these parameters from the moment of admission, stay and discharge from the health center.

18) The device can also assess differential pressure levels of cerebrospinal fluid between cerebral subarachnoid segments 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. By placing noninvasive digital electrodes or sensors in these windows, it will be possible to measure and quantify cerebrospinal fluid pressure and flow in both adults and pediatrics. These ultrasound windows specifically related 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 skull base trauma, and consequently preventing the placement of electrodes or the approach in this area, therefore, it may be possible to choose to perform monitoring through the subarachnoid space at the level of the spinal cord, the lumbar space being the most suitable anatomical topographic area. Also, the cervical and thoracic or dorsal pathways in the spinal neuroaxis are feasible for monitoring, in case there is a contraindication due to injuries in the lumbar area.

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

21) By means of electrodes connected from the monitor's wiring system to the patient's anatomical-topographic surfaces.

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 (transmitter 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 non-invasive cerebrospinal fluid monitor, but this piece will also be multifunctional by being able to 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 briefly and partially with the National Copyright Office (ONDA) in the Dominican Republic in the form of a medical essay, which has not yet been published.

26) Along the same lines, another function of this multifunctional support base is to correctly modify the current hands-free technique for 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 (the technique currently used) 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 hands-free technique is described is the medical article entitled: Ultrasound-Guided Interventional Surgery: What Every Radiologist Should Know. This interesting and comprehensive medical article was written by Drs. J.L. Del Cura, R. Zabalaa, and I. Cortaa, from the Radiodiagnostic 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 through ultrasound, the hands-free technique is also detailed in different anesthetic procedures in 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, Ultrasound 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 regard, 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 non-invasive monitor will be placed and adjusted. This mobile head of the support arm will allow 360-degree movement both clockwise and counterclockwise, with the ability to allow movements in all directions, including diagonal turns forward and backward, or to rotate and move on its own mobile central axis to any topographical-anatomical point.

31) The multifunctional base may be of two types:

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

33) Dual-screen base: in this mode, the monitored cerebrospinal fluid values will be displayed on its crosspiece, transmitted from the monitor via a wireless connection. In this case, this crosspiece of the multifunctional support base will have an additional integrated screen that will receive the results of the cerebrospinal fluid assessment from the monitor.

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

34) Due primarily to the different anatomical pathways required for cerebrospinal fluid analysis, the electrodes of the noninvasive device will be designed according to the anatomical topographic area to be evaluated. Therefore, some monitor and electrode designs may be:

35) Eye patch type electrodes made of foam and silicone lined with moist gel (pediatric and adult) to be placed at the level of the eyeball, eye mask and virtual glasses with ultrasonic and/or mixed technologies with laser Doppler to be placed in both the right and left ocular area, pediatric headband (ultrasonic headband) with integrated screen with the aim of positioning it over the parietotemporal area, disposable electrodes like 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 non-invasive cerebrospinal fluid monitor may be integrated into any other monitor in the area of anesthesiology.

37) All monitors will have rechargeable power supplies, a micro USB port and standard USB port, a battery charge indicator, and an output for printing CSF (cerebrospinal fluid) flow rate and blood pressure readings. The device's cabling can be unfolded and coiled within its own compartment or monitor housing. Portable monitors will be attached to their base, which will be used for electrical battery recharging.

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

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

40) The multifunctional dual-screen support base can be located in the front area of the anesthesiology service. It can be compatible with other anesthesiology monitors and display the other anesthesiology monitoring parameters on its crosspiece and fold-out screen. This fold-out screen can be designed in any size or dimension for easy readability. One advantage of this modality is that the monitored medical parameters would be supervised in front of (in plain view of) the anesthesiology service throughout the anesthetic surgical procedure, and not behind (the back area) or to the sides of the anesthesiologists, as is currently the case.

41) The multifunctional support base will be placed on the side rail of the surgical stretcher. It may also be located and designed on a mobile pedestal base with casters, 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 include supports for extension cords and anesthetic infusions.

42) The noninvasive 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 upon activation. It will also include an alarm indicating abnormal blood pressure readings. The readings and results from the noninvasive monitor can also be reviewed remotely (Wi-Fi or Bluetooth).

43) The non-invasive monitor will allow you to select time intervals 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 non-invasive device will measure cerebrospinal fluid pressure in mm H20, but can also convert the results into 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 or perpendicular surfaces 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 rate and tension of the cerebrospinal fluid). For example, in the present textual content there is a model of a wireless portable pen-type monitor with the objective of being used at an optical level for noninvasive recording of cerebrospinal fluid in emergency areas or in the doctor's office. In this regard, another different design will fit 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 above, the following is added:

Regarding item 0, the device will have 4 images or icons that will 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), spine (spinal cord), and brain (lateral ventricle). By selecting and pressing one of these images, the monitor will initiate 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 integrated electronic circuit, the basic components thereof being: Micro Amplifier plus electronic noise filters, band pass filters, a cerebrospinal fluid flow direction separator, microcontroller and integrated microprocessor which will be programmed to execute and interpret all the functions of the device, graphic and numerical backlit 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 cerebrospinal fluid pressure waves, and in addition, 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, the monitor will be capable of continuously monitoring, in real time and noninvasively, the dynamic tension, pressure waves, and flow rate of cerebrospinal fluid in the subarachnoid space of the brain, the eye, and the spinal cord. The pressure results will be displayed on the screen in mm H2O, the pressure waves in a digital spectrogram, and the flow rate in milliliters per minute, respectively.

An integrated system of noninvasive detectors will reliably confirm each scanned parameter. These detectors contain an image sensor and image recognition memory linked to artificial intelligence. These detectors will capture, archive, compare, and recognize high-resolution images of the different areas of the subarachnoid space to be evaluated by the device. In this regard, the monitor will be able to store the morphological images of the meninges of each scanned subarachnoid space in its micromemory, from its initial condition to its final resolution. Through plugins and an output assistant integrated into the monitor's circuit, it will be possible to examine the scanned images using PCs, computers, and mobile phones, both by direct connection from the noninvasive cerebrospinal fluid monitor and also wirelessly or remotely.

Regarding item 4, please note that the use of laser Doppler will be based on near-infrared spectrometry. Two different models of invasive monitor will be developed. The first will be developed using ultrasound, while 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, by developing the noninvasive device using both different techniques separately, the same objectives will be pursued related to the real-time quantification of cerebrospinal fluid pressure, flow rate, and pressure waveform. Therefore, the two technologies that demonstrate greater fidelity, medical precision, and advantages in the area of noninvasive cerebrospinal fluid neuromonitoring 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 ultrasonic interfaces coming from non-target anatomical areas or areas that are not relevant to the analysis in question, for example, the device will reject echo reception coming from blood vessels, anatomical structures that occupy 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 because 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 the echo emission-reception when the ultrasounds pass through the different anatomical interfaces from the cutaneous surface to the subarachnoid space to be evaluated, in addition to the echogenic characteristics of each of them.

Cerebrospinal fluid quantification will be performed in different sections of the subarachnoid space continuously and in real time, both at the level of the cerebral lateral ventricle, the second cranial nerve, and the spinal cord. The mechanism will consist of quantifying tension by evaluating the collisions and force exerted between the arachnoid meninges and the pia mater by the cellular and molecular complex that makes up the cerebrospinal fluid in its entirety, or a representative fraction thereof, on a specific area in the subarachnoid space. In this way, the noninvasive monitor will quantify the kinetics or pressure of the cerebrospinal fluid.

The mechanisms by which the non-invasive 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 software program 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 densities of the cerebrospinal fluid, obtaining, if they exist, pathological variants that occur with abnormal densities of the cerebrospinal fluid, as is the case, for example, of subarachnoid hemorrhage. The monitor, through 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 pressure from 70 to 200 mmH2O.

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

The imperative reason why the present 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 ratify the ultrasonic impedance coming from the subarachnoid space under any pathological condition. Dynamic pressure is frequently expressed in Pascal, although the device will display the results in mm H2O based on the fact that 1 mmH2O = 9.80665 pascals (Pa) or, 1 mm H2O = 9.8 pascals (Pa).

In this regard, 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, note that, in terms of volume, the device will noninvasively assess cerebrospinal fluid flow rate, determining the volume circulating in real time through a specific segment of the subarachnoid space per unit of time. This volume will be quantified in milliliters per second and/or minute. Under normal conditions and in adults, cerebrospinal fluid circulates at a rate of 20 ml per minute, a parameter used as a normal reference by the device to calculate its transit time 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 circulating in the subarachnoid space of the brain, the perioptic space, and the spinal cord. These volumes will be quantified based on the Doppler flow or effect by evaluating the difference between the ultrasonic 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 flow velocity of the cerebrospinal fluid in the subarachnoid space. Due to the bidirectional Doppler processor system of the present non-invasive device, the flow direction of dynamic circulation can be detected mainly in the spinal cord. Physiologically, CSF flow alternates the direction of its circulation in a caudal direction with a cephalic direction. The main circulatory flow is in a craniocaudal direction and cephalic reflux is produced by turbulence. In the spinal cord, there is a continuous bidirectional flow consisting of a caudal direction on the dorsal surface and cephalic 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 connected by a micro-wiring system to the non-invasive device. This connection will emit ultrasonic pulses to the spinal region to be scanned. 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 ultrasonic frequencies between 1 and 5 MHz to identify the subarachnoid space and cerebrospinal fluid. In contrast, in pediatrics the device will use 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 biological development or growth process in pediatrics.

Regarding item 7, please note that laser spectroscopy is capable of tracking the perioptic subarachnoid space at the ocular, spinal cord and brain levels.

Regarding item 8, indicate that, related 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) for the purpose of establishing a multicenter 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 cerebrospinal fluid through the photoemission and photoreception of near-infrared photons is based on:

This device will use two transcutaneous sensors, each consisting of a light source with two different wavelengths and two photodetectors. The photodetector closest to the light emitter will measure the most superficial tissue layers (not the target tissue or cerebrospinal fluid), and the photodetector farther away, combined with the device's optical density and pressure sensor, will scan the subarachnoid space and cerebrospinal fluid, yielding pressure and flow rates due to the difference in photon absorption between the light emitted in nanometers and that absorbed by the cerebrospinal fluid. Therefore, the device's operating mechanism is as follows:

❖ 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, essential 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 disperse 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. Therefore, the device's quantification 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 through the device will be carried out with the hemoglobin (protein) of the red blood cell, producing as a consequence of 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 amount 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 aggressions, this will also trigger an increase in photonic absorption which will be reflected in the device's photodetector when capturing the photons that return to it.

To develop this device, the absorption 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 skin 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, lengths ranging from 730 nm to 2,600 nm (nanometers) will be used. Integrated software for optical (spectroscopic) applications will analyze and calculate each parameter to be scanned, using as a normal reference the photon absorption index or ratio, as well as the amount of emitted beams not absorbed by tissue compartments throughout the path to the subarachnoid space and cerebrospinal fluid. Patients with normal pressure and flow rates, in which the photo-emitted-received interaction is physiological, will be compared with photon absorption rates in pathological conditions that alter cerebrospinal fluid pressure and flow rates. Photoreceptors will also be able to discriminate wavelengths originating from non-target tissues using an application program.

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

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

Regarding item 9, note that the dynamics of cerebrospinal fluid, due to Bernoulli's principle, continuously circulates through a complex system of septa, trabeculae, cisterns, and foramina. Therefore, and in a general sense, cerebrospinal fluid circulation is not static, and therefore, it does not remain motionless, stagnant, or adynamic, merely occupying a space. Rather, its dynamics remain in constant motion, exerting a certain degree of friction, force, and pressure on the structures through which it moves. In this regard, a graphic is designed on the monitor to show the pressure wave as a result of its active circulation as it travels through the subarachnoid space of the brain and continues its dynamics through the spinal cord.

The importance of developing graphic vectors using a digital spectrogram on the device's screen would be to analyze the patterns, behaviors, or tensional splits of cerebrospinal fluid in the presence of different pathological entities that present with subarachnoid hemorrhage, thrombotic stroke, cerebral edema, among other conditions. Furthermore, the dynamics of cerebrospinal fluid pulsatile waves would be evaluated in different general anesthetic procedures, including conductive spinal anesthesia. Type A or plateau waves, B and C waves could be monitored, archived, and recorded by this device. The digital spectrogram will be presented in real time on the device's high-resolution screen using an algorithm based on a sequence of Fourier Transforms.

Regarding item 10, indicate that, prior to the ocular approach using the non-invasive device, the ocular function of the same will be selected, then the device will use high frequency ultrasound, which will range between 5 - 7.5 up to 20 MHz. The scanning will begin when the device and its transducer or its electrodes are placed in contact with the upper eyelid, in both cases the placement must be transversely over the naso-orbital cutaneous part of the upper eyelid (either in the left or right eye), then the device will 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 ocular level). This action will be assisted by the echo-emitter-receiver ultrasound beams (in the ultrasound device) to jointly track and identify the area corresponding to the posterior ocular pole, the anatomical region where the papillary zone and the beginning of the optic nerve path are located, as well as the subarachnoid space. In this regard, the device will have three ways to identify the subarachnoid space and its contents, the cerebrospinal fluid:

• Through the echogenic timing and characteristics due to the echo emission-reception pulses 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 installed in the microcontroller and microprocessor will be able to perform automated ultrasound and laser spectroscopic measurements of meningeal encasement dilation 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 monitor using any computer or mobile device with a screen, via the external auxiliary unit of the noninvasive cerebrospinal fluid monitor, or remotely.

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, various situations and pathological entities are briefly outlined 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 the cerebrospinal fluid.

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

In general, the listing of medical applications of the device has been done with the intention of maintaining a schematic order in addition to specifying the medical purpose for which this device has been conceived.

Regarding item 19, in the case of access through the transtemporal and temporoparietal windows, please note that the lateral cerebral ventricle will be evaluated through the transtemporal window (temporal scales) following current medical protocol, placing the sensors and 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 for scanning, as it is occupied by cerebrospinal fluid.

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

Regarding item 23, indicate that a directional or focused ultrasound system integrated into the monitor will be developed using the sonic modulation and amplification technique by which the ultrasounds emitted from the emitting echo 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 pinpoint light indicator in the topographic area that would 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, indicate that transcutaneous sensors with emitters of two and three different types of wavelengths can also be used, each with its own photodetector (for laser device).

DESCRIPTION OF THE FIGURES

Figure 1.- Shows a view of the device to quantify the flow and pressure of cerebrospinal fluid in a non-invasive 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 the ocular level using a non-invasive 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 non-invasive 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 cerebrospinal fluid

05) Port for electric power

06) USB port

07) Output port for printing

08) Connector for wiring the device's electrodes

09) Wireless remote signal transmitter of the device

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

11) On/Off button

12) Textual indicator of Cerebrospinal Fluid (CSF)

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) Device Wiring and Electrode

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 the reference point of the fourth lumbar vertebra and the topographic area where the monitoring electrodes are placed). Spinal cord in blue.

25) Vertebral column (cervical, thoracic, lumbar and sacrococcygeal 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 be monitored)

28) Arachnoids

29) Dura mater

Figure 3 shows a variant of the Portable Pen-Type 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 the ocular level using a non-invasive 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 rotation of movements in all directions including 360-degree angles.

40) Cross piece of the multifunctional support base

41) Circular piece for forward and backward movements and displacements.

42) Rising piece of the multifunctional support base

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 joined 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 mirroring on the crosspiece of the support base. Its function is to wirelessly receive the results from the monitor on your screen.

50 (b) Enlarged 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 (the image shows indicator movements in all directions on its own central axis including 360 degree rotations to the right and left)

57) Dual screen (Screen Mirroring) on the crosspiece of the multifunctional support base via wireless connection with the non-invasive device.

58) Non-invasive device (screen omitted in this drawing)

59) Connector of the multifunctional base to the operating room stretcher (with 360-degree movement indicator with right and left turns and forward and backward movements of the support base on the surgical stretcher).

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

Claims (35)

1.- Non-invasive cerebrospinal fluid monitoring equipment comprising a monitor comprising 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; characterized in that it also includes an application program and algorithms for the assessment of photon absorption and interpretation of the normal and abnormal protein content of the subarachnoid space using near-infrared spectrometry and its direct relationship with the pressure and flow dynamics of the cerebrospinal fluid. 2. - Non-invasive cerebrospinal fluid monitoring equipment according to claim 1, comprising a multifunctional support base which, in turn, comprises a support for the monitor and supports for the ultrasound transducers in anesthesiology. 3. - Non-invasive cerebrospinal fluid monitoring equipment according to any of the preceding claims, wherein the ultrasonic sensors, software and application algorithms comprise sensors with ultrasonic densitometer effect and Doppler effect. 4. - Non-invasive cerebrospinal fluid monitoring equipment according to any of the preceding claims, wherein the sensors comprise Doppler effect laser sensors. 5. - Non-invasive cerebrospinal fluid monitoring equipment according to any of the preceding claims, wherein the sensors comprise sensors selected from: • modified intense pulsed light, • infrared variety or near-infrared spectroscopy, • ocular micropressure techniques, • strain gauges, optical or other digital pressure sensors, and • combination of ultrasonic and laser sensors. 6. - Non-invasive monitoring equipment for cerebrospinal fluid according to any of claims 3 to 5, wherein 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 composes 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 in addition, to analyze, process and verify the dynamic pressure of the subarachnoid space due to sensors for detecting the density of the contents of the cerebrospinal fluid. 7. - Non-invasive cerebrospinal fluid monitoring equipment according to any of the preceding claims, comprising at least one graphic display. 8. - Non-invasive cerebrospinal fluid monitoring equipment according to any of the preceding claims, comprising the approach through the perioptic subarachnoid space, by means of any of its sections, being able to track the subarachnoid space in a determined section within its total meningeal length of approximately 4 to 5 cm. 9. - Non-invasive cerebrospinal fluid monitoring equipment 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 the same or its restoration to normal levels after procedures. 10. - Non-invasive cerebrospinal fluid monitoring equipment according to any of the preceding claims, which uses conventional transcranial ultrasound windows as reference points for placement of non-invasive electrodes or sensors. 11. - Non-invasive cerebrospinal fluid monitoring equipment according to claim 10, wherein the transcranial ultrasound windows comprise: • Transtemporal and temporo-parietal windows; • transorbital; • frontoparietal region; • sub-occipital; and • spinal. 12. - Non-invasive cerebrospinal fluid monitoring equipment 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 and receivers placed in anatomical topographic areas to be monitored, wirelessly connected to the monitor; or • Ultrasonic emitters or laser spectroscopy sources integrated into the monitor capable of directing their beams to the anatomical topographic area to be monitored. 13. - Non-invasive cerebrospinal fluid monitoring equipment according to any of claims 2 to 12, wherein 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. 14. - Non-invasive cerebrospinal fluid monitoring equipment according to any of claims 2 to 13, 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. 15. - Non-invasive cerebrospinal fluid monitoring equipment according to any of claims 2 to 14, wherein the multifunctional base comprises at its distal and terminal end a mobile head in which the ultrasound transducer and/or the non-invasive monitor is placed and adjusted. 16. - Non-invasive cerebrospinal fluid monitoring equipment according to claim 15, wherein the mobile head of the support arm can be moved in 360-degree movements both clockwise and counterclockwise. 17. - Non-invasive cerebrospinal fluid monitoring equipment according to any of claims 2 to 16, wherein the multifunctional support base lacks an electrical power supply. 18. - Non-invasive cerebrospinal fluid monitoring equipment according to any of claims 2 to 16, wherein 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. 19. - Non-invasive cerebrospinal fluid monitoring equipment according to any of the preceding claims, comprising electrodes designed according to the anatomical topographic area to be evaluated, where said electrodes are selected from: • Eye patch electrodes made of foam and silicone lined with moist gel (pediatric and adult) to be placed at the level of the eyeball, • an eye mask and virtual glasses with ultrasonic and/or mixed technologies with laser Doppler to be placed on both the right and left ocular area, • an ultrasonic pediatric headband with an integrated screen with the aim of positioning it over the parietotemporal area, • disposable contact lens-type electrodes, and • Foam and silicone spinal electrodes with moist gel to be connected via cables from the monitor to the spine. 20. - Non-invasive cerebrospinal fluid monitoring equipment 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 flow rate and pressure figures of cerebrospinal fluid. 21. - Non-invasive cerebrospinal fluid monitoring equipment according to any of the preceding claims, comprising reels for the wiring in its own compartment or housing. 22. - Non-invasive cerebrospinal fluid monitoring equipment according to any of the preceding claims, which is materialized in a portable format comprising battery electric recharging connections attachable to its base. 23. - Non-invasive cerebrospinal fluid monitoring equipment according to any of the preceding claims, comprising ultrasonic frequencies ranging from 2, 5, 8 to more than 20 MHz 24. - Non-invasive cerebrospinal fluid monitoring equipment according to any of claims 2 to 23, wherein the multifunctional support base comprises: -anchors for the side rail of the surgical stretcher, and -a mobile pedestal base with casters, which will be in contact with the ground 25. - Non-invasive cerebrospinal fluid monitoring equipment according to any of claims 2 to 24, wherein the multifunctional support base will also consist of supports for anesthetic extensions and infusions. 26. - Non-invasive cerebrospinal fluid monitoring equipment according to any of claims 7 to 25, wherein the screens comprise backlit LED/LCD graphic screens with a multilingual menu and have storage media with a memory capacity of 100 to 250 measurements, comprising an alarm indicating abnormal blood pressure figures and a telematic connection. 27. - Non-invasive cerebrospinal fluid monitoring equipment according to any of the preceding claims, comprising a time interval selector 28. - Non-invasive cerebrospinal fluid monitoring equipment according to any of the preceding claims, comprising a cerebrospinal fluid pressure unit converter. 29. - Non-invasive cerebrospinal fluid monitoring equipment according to any of the preceding claims, comprising a rear anchor in the rear part of its housing. 30. - Non-invasive cerebrospinal fluid monitoring equipment according to claim 1, comprising a wireless portable pen-type format. 31. - Non-invasive cerebrospinal fluid monitoring equipment according to claim 1, comprising a portable format fitted to the retroauricular region. 32. - Non-invasive cerebrospinal fluid monitoring equipment 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. 33. - Non-invasive cerebrospinal fluid monitoring equipment 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 contents, the cerebrospinal fluid. 34. - Non-invasive cerebrospinal fluid monitoring equipment according to any of the preceding claims, comprising a memory and artificial intelligence for the recognition of physiomorphological and pathological images of the subarachnoid space, the latter due to conditions of intracranial hypertension. 35. - Non-invasive cerebrospinal fluid monitoring equipment 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.