RU2797239C2 - Method and system for non-invasive treatment and monitoring of intracranial pressure and device for measuring change in skull volume - Google Patents

Abstract

FIELD: medical devices.

SUBSTANCE: invention describes a method and system for non-invasive treatment and monitoring of intracranial pressure and a device for measuring changes in skull volume. The group of inventions describes a method and system for non-invasive treatment and monitoring of intracranial pressure and a device for measuring changes in the volume of the skull. A system is proposed for implementing the method, the method including the steps of the following: detecting signals by means of a detecting device located on the user's head, wherein the following steps are carried out: converting analog signals into digital ones; digital signal filtering, which filters a subset of the least significant bits of the digital signals, said filtering step comprising: identifying trigger events based on the digital signals; wherein the software determines the correct placement of the detecting device on the user's head in the following steps: i. comparison by software during initial setup of the most significant bits of the digital signal with a predetermined threshold value to determine when the detecting device has been properly mounted on the user's head; and ii. initially transmitting by the transmitter, in accordance with the software, the entire digital signal, and then transmitting only the least significant bits until the software detects the removal of the detecting device; and transmitting the processed signals containing only the least significant bits by means of a transmitter to a preset receiver, wherein the transmitter and preset receiver are in wireless communication; moreover, the processed signals containing only the least significant bits are transmitted until another trigger event is detected, and the pre-configured receiver is configured to recover the entire digital signal; however, after the software detects another trigger event, the entire digital signal is transmitted by the transmitter to the preconfigured receiver.

EFFECT: group of inventions provides non-invasive treatment and monitoring of intracranial pressure.

15 cl, 25 dwg

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority from Brazilian application No. 1020170238792, filed November 6, 2017. The disclosure of the above application is incorporated herein by reference in its entirety.

FIELD OF TECHNOLOGY

[0002] The present invention describes a method and system for non-invasive treatment and monitoring of skull volume change and a device for measuring skull volume change. In particular, the invention comprises detecting a change in the volume of the skull in an analog signal, processing this signal, and transmitting this signal to another electronic device or to a cloud server. The present invention relates to the field of medicine, biomedicine, neurology, measurement of physical quantity and electrical engineering.

BACKGROUND OF THE INVENTION

[0003] Most human organs show an external blood perfusion pressure close to or below atmospheric pressure. However, in the central nervous system, which includes the brain and spinal cord, the external pressure is different because it is protected by the intracranial cavity and spinal canal. This pressure is called intracranial pressure.

[0004] Intracranial pressure (ICP) is one of the most important physiological parameters of animals and humans, and its morphology is very important. However, the conventional methods for detecting, monitoring and treating the user's intracranial pressure are mainly invasive methods, while the current state of the art requires non-invasive systems, which expands the field of research related to an important neurological parameter that is not studied enough due to the invasive method of monitoring intracranial pressure. .

[0005] For example, it is well known that the variability of cardiac activity and other complex parameters can determine the future clinical condition of the patient and the onset of fatal outcomes. For patients with neurological risks, analysis of the correspondence between intracranial pressure and blood pressure provides information about cerebral homeostasis, which is a decisive factor in the decision-making process regarding the choice of the best treatment to be applied. However, in practice, analysis is rarely used to obtain relevant information for hospital staff.

[0006] Currently, monitoring the physiological parameters of patients in intensive care units provides a very large amount of data for the decision-making process, which is usually not used enough by hospital staff. The tools currently in use, such as multi-parameter monitor alarm protocols that are triggered when physiological parameters deviate from the standard pattern, are obviously more disruptive than helpful: less than 10% of the alarms generated in intensive care units are clinically significant. It is estimated that 28% of ICU diagnoses in the US are erroneous, 8% of these errors are fatal. In pediatric intensive care units, 19.6% of diagnoses are misdiagnosed, 4.5% are fatal. Consequently, more than 40,000 people die each year in intensive care units in the United States due to misdiagnosis.

[0007] In order to optimize treatment protocols, improve patients' quality of life, and reduce misdiagnosis and hospital costs, it is necessary to provide better diagnostic tools for healthcare professionals to deliver relevant critical patient information and facilitate decision making. Common methods for monitoring intracranial pressure include penetrating the skull and inserting a catheter to measure ICP. This procedure is invasive and involves risks of complications of cerebral edema, parenchymal injury, intracerebral hemorrhage, and intracranial infection, the latter being the most common. In view of all the disadvantages mentioned, there is a very strong need for monitoring intracranial pressure in a non-invasive way that would avoid the complications created by penetration into the skull, since this method opens up new areas of research related to this important physiological parameter, which have almost not been developed due to invasive monitoring method. In addition, with the development of non-invasive monitoring methods, the practical value of the invasive method will increase due to the need to confirm the monitoring of absolute intracranial pressure.

[0008] The current state of the art further requires a system for wireless monitoring of intracranial pressure in order to contribute to the performance of the system in different circumstances.

[0009] A search of the scientific and patent literature has highlighted documents relevant to the present invention, which are described below:

[0010] WO 2013041973 A2 presents a system for measuring and monitoring intracranial pressure in a non-invasive manner, with the system connected by cables for monitoring intracranial pressure, which makes it difficult to adapt the system to a variety of situations, and transporting the system can harm the system.

[0011] Document CN 106618490 A presents a minimally invasive system for determining the temperature and intracranial pressure of a patient using a different method of processing data and transmitting signals wirelessly. The minimally invasive system still needs to be inserted into the patient's body, making it too dangerous in some situations or to be used every time the patient needs it. In addition, the CN 106618490 A system generates a large amount of irrelevant data transmitted to the receiver in such a way that a minimally invasive system needs suitable equipment capable of handling a large amount of transmitted information traffic. As a result, it is practically impossible for the user to handle the system.

[0012] Document CN 202458347 U presents a system for monitoring intracranial pressure in an indirect manner, wherein the document presents a method for determining a plurality of physiological parameters, and processing the plurality of these parameters represents the intracranial pressure of a patient. Said system needs to determine many parameters and does not determine the intracranial pressure directly, since the applicant emphasizes that the system is intended to measure the blood pressure, electrocardiogram, electroencephalogram, bioimpedance and oxygen saturation of the patient and, after that, to conclude the patient's intracranial pressure.

[0013] Document CN 106361320 A presents a minimally invasive system for monitoring intracranial pressure, with the sensor located directly on the patient's skull, requiring an incision in the patient's head, which makes the system according to this document practically unusable in every case where it is necessary to monitor intracranial patient pressure. This solution provides an invasive procedure for collecting information related to the patient's health status.

[0014] As can be inferred from the literature, there are no documents proposing or planning the ideas of the present invention, so the solution proposed in this application is characterized by novelty and inventive step compared to the state of the art.

SUMMARY OF THE INVENTION

[0015] The present invention solves the technical problems of the state of the art by providing a system and method for non-invasive treatment and monitoring of intracranial pressure and a device for measuring changes in skull volume. In particular, the present invention includes detecting and receiving an analog signal of a change in the volume of a user's skull, processing this signal, and wirelessly transmitting the processed signal to a pre-configured receiver. The proposed solution allows non-invasive determination of the deformation of the user's skull and high-precision monitoring of intracranial pressure.

[0016] In one aspect, the present invention provides a method for non-invasive treatment and monitoring of intracranial pressure, the method comprising the following steps:

a. detecting analog signals from a user by means of a detecting device;

b. receiving the detected analog signals by the receiver, each of the signals depending on the intracranial pressure of the user;

c. processing by the processor of the detected analog signals, with the formation of the processed signals; And

d. transmitting the processed signals via a transmitter to a pre-configured receiver, wherein the transmitter and the pre-configured receiver are wirelessly connected.

[0017] In a second aspect, the present invention provides a system for non-invasive treatment and monitoring of intracranial pressure, the system comprising:

a. a detecting device for detecting analog signals of changes in the volume of the skull;

b. a receiver in communication with the detecting device and receiving analog signals related to the user's intracranial pressure;

c. a processor comprising at least a tool for processing signals associated with the user's intracranial pressure, the processor being in communication with a receiver; And

d. a transmitter, wherein the transmitter is in communication with the processor and includes a module for wirelessly transmitting the processed signals.

[0018] In a third aspect, the present invention provides a device for measuring skull volume change, comprising:

a. a change transducer (8) comprising a change detector provided with a first end configured to sense a deviation depending on a change in skull volume, the change transducer (8) converting the detected change into an electrical signal; And

b. housing, and the measuring transducer (8) changes is located inside the housing.

[0019] The above and other aspects of the invention will be immediately appreciated by a person skilled in the art and companies having an interest in this product segment, and will be set forth in sufficient detail in the following description.

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The examples given in this application are intended only to illustrate some ways of implementing the present invention, but without limiting its scope. On the drawings:

[0021] FIG. 1 is a flow chart of a method according to an embodiment of the present invention for non-invasive treatment and monitoring of skull volume change, wherein the detected analog signal is processed to represent skull volume change signals in units such as volts.

[0022] FIG. 2 is a flowchart of a method according to another embodiment of the present invention for non-invasive treatment and monitoring of skull volume change, wherein the detected analog signal is further processed to represent skull volume change signals in units such as micrometers.

[0023] FIG. 3 is a flowchart of a method according to another embodiment of the present invention for non-invasive treatment and monitoring of skull volume change, wherein a plurality of detected analog signals are processed to represent skull volume change signals in units such as micrometers and suppress environmental noise. in an analog signal depending on the ICP of the user.

[0024] FIG. 4 is a schematic representation of one embodiment of the system, showing the operation of the system.

[0025] FIG. 5-7 are exploded perspective views of an embodiment of the present invention for non-invasive detection and monitoring of skull volume change, where FIG. 7 is an exemplary view of FIG. 5 for a clearer description of the embodiment.

[0026] FIG. 8 shows an embodiment of a device for measuring changes in skull volume.

[0027] FIG. 9-12 are views of an embodiment of a system for non-invasive treatment and monitoring of skull volume changes.

[0028] FIG. 13-17 are views of an embodiment of a system for non-invasive treatment and monitoring of changes in the volume of the skull, located in the girth of the user's head.

[0029] FIG. 18-20 are views of another embodiment of a system for non-invasive treatment and monitoring of changes in the volume of the skull, located in the girth of the user's head.

[0030] FIG. 21 - circulation of cerebrospinal fluid in the central nervous system.

[0031] FIG. 22 is a plot of a Landfitt curve where the y-axis represents intracranial pressure and the x-axis represents intracranial volume.

[0032] FIG. 23 is a graph of intracranial pressure over time, where the upper curve represents a satisfactory homeostasis and the lower curve represents an unsatisfactory homeostasis.

[0033] FIG. 24 is a plot of the Lundberg A curve, a plateau showing the change in intracranial pressure over time.

[0034] FIG. 25 is a plot of the Lundberg B curve, pulses, showing the change in intracranial pressure over time.

DETAILED DESCRIPTION OF THE INVENTION

[0035] Intracranial pressure usually has a value below 10-15 mm Hg. Art. in adults, and the intracranial contents are protected by the skull, which is a rigid structure with an internal volume of 1400-1700 ml. Under normal conditions, intracranial contents contain by volume: brain parenchyma from 80% to 85%, cerebrospinal fluid from 5% to 10%, blood from 8% to 12%.

[0036] Cerebrospinal fluid is a colorless water-based fluid with small amounts of protein, potassium, glucose, and sodium chloride that occupies the subarachnoid space and ventricular cavities, while cerebrospinal fluid performs mainly the function of protecting the central nervous system and distributing pressure along Pascal's principle, and equally distributed over all points of the skull indicated in Fig. 21 where the arrows show the direction in which the fluid flows. Thus, the cerebrospinal fluid acts as a shock-absorbing system of the central nervous system, since the central nervous system is immersed in fluid, which reduces the risk of brain injury that occurs with direct contact with the skull. If the brain parenchyma or blood vessels increase in volume, then the fluid is drained and the intracranial pressure is reduced to a certain limit in order to regulate the volume in the skull.

[0037] From a neurological point of view, one of the most important aspects for the intracranial cavity is that the cavity is completely closed, which does not allow a significant change in volume, however, the change is sufficient to be detected using the method, system and device of the present invention. An increase in the volume of any component is transmitted to other components, resulting in an increase in intracranial pressure, as shown in FIG. 22 where the x-axis represents volume and the y-axis represents ICP. Tumors, hematomas and other intracranial volume-expansive processes compress not only the affected areas, but also all structures in the intracranial cavity.

[0038] A normal ICP curve is shown in FIG. 23, it is a modified arterial pulse and consists of 3 characteristic peaks. Peak P1 is called the first main sphygmographic wave and is caused by blood pressure transmitted from the choroid plexus. Peak P2 is called the second additional sphygmographic wave, which varies depending on cerebral homeostasis, and is an echo of P1. The P3 peak is called the dicrotic wave and precedes the closure of the aortic valve.

[0039] If monitoring of intracranial pressure is recorded over time, then some waveforms may be clearly distinguished. Lundberg waves can be divided into 3 types. As seen in FIG. 24, curves A, plateau, always represent abnormal increases in intracranial pressure within the range of 100 mmHg. Art. within 2-20 minutes, with a sharp drop to the initial level, possibly reflecting the expansion of cerebral vessels, and are interpreted as threatening signals of decompensation of intracranial pressure. As seen in FIG. 25, curve B, pulses appear 0.5-2 times per minute, with an amplitude of up to 50 mm Hg. Art., reflecting the effect of the respiratory cycle on intracranial pressure. These signals are observed in normal individuals, but indicate intracranial pathology when the amplitude exceeds 10 mm Hg. Art. Curves A and B are alarms of a possible violation of homeostasis. Curve C occurs 4-8 times per minute and refers to the Traub-Goering-Meier blood pressure curves.

[0040] Intracranial pressure monitoring can measure pressure and provide important information about intracranial dynamics and brain homeostasis through waveform analysis. ICP analysis provides information that identifies users with low adaptive potential (poor homeostasis scores) who are sensitive to increases in ICP and increases in cerebral perfusion pressure.

[0041] Thus, in one aspect, the present invention provides a method for non-invasive treatment and monitoring of intracranial pressure, the method comprising the following steps:

a. detecting analog signals from a user by means of a detecting device;

b. receiving the detected analog signals by the receiver, each of the signals depending on the intracranial pressure of the user;

c. processing by the processor of the detected analog signals with the formation of the processed signals; And

d. transmitting the processed signals via a transmitter to a pre-configured receiver, wherein the transmitter and the pre-configured receiver are wirelessly connected.

[0042] The term user in the present invention refers to a human or animal on which the system is capable of detecting a change in skull volume.

[0043] The stage of detecting analog signals from the user comprises detecting a change in the volume of the skull and / or deformation of the skull, while its change causes a deviation of the pin, and the said deviation is positive or negative, and since the change transducer (8) is connected to the pin, the pin deforms the change transducer (8), and the change transducer (8) generates a differential voltage signal related to the user's intracranial pressure. This differential voltage signal is received by the receiver and signal processing begins.

[0044] In an embodiment, the detected signals from the change transducer (8) are sent to a receiver, which is transmitted to the processor.

[0045] The step of receiving the detected analog signal by the receiver comprises the ability to perceive any analog signal sent by the detecting device, without limitation, in any manner performed by the detecting device. At this stage, the detected analog signals pass through an electronic circuit that can generate information in an electronic form that can be read by the processor. In an embodiment, the received analog signal is detected by a pressure sensor, a mechanical sensor, an inductive sensor, a liquid crystal sensor, a laser sensor, a strain gauge, an optical sensor, or a combination thereof.

[0046] In another embodiment, the receiver includes the ability to receive multiple analog signals, wherein the receiver may receive the signals via serial communication or parallel communication. In an embodiment, the plurality of analog signals may be, without limitation, signals related to temperature, ambient pressure, humidity, orientation, angular velocity, acceleration, magnetic field, and geolocation.

[0047] The processing step performed by the processor limits the type of processor and tools that are required in the processing step. The processor contains at least one tool for processing said analog signals, the tools being described below.

[0048] A tool for converting detected analog signals into digital signals related to the user's intracranial pressure without losing the effectiveness of monitoring the intracranial pressure. In an embodiment, the tool is an analog-to-digital converter.

[0049] In an embodiment, the processor uses one of its user ICP signal processing tools to convert the detected signals into digital signals, and amplifies those signals using other tools to obtain a processed signal for wireless transmission by a transmitter. similar to that in FIG. 1 shows the transformation before the additional tool step.

[0050] A tool for filtering digital signals for transmission by a transmitter, said filtering being performed by firmware to filter the most relevant information from the digital signals. In an embodiment, the tool is a filter, wherein the filter performs filtering on the digital signals for transmission by the transmitter.

[0051] In an embodiment, the filtering performs event-based sorting on an event-based tool protocol, wherein the firmware identifies the change of the most relevant digital signal information and transmits the processed signals.

[0052] In one exemplary embodiment, the analog signals from the detecting device are converted to digital signals by means of an analog-to-digital converter, for example, with 32-bit resolution. After the detecting device is correctly placed on the patient, changes in the measurement data are only expected in a subset of bits (eg, 12 least significant bits). To improve wireless communications, firmware is designed to transmit the most relevant information (ie, a subset of the least significant bits), while filtering out less relevant information (eg, the remaining more significant bits).

[0053] During the initial device setup, the firmware analyzes the entire digital signal to identify trigger events. Detecting the correct placement of the detecting device on a patient is one exemplary event. During the initial setup of the device, the detecting device is moved and the digital signals will undergo significant amplitude changes; and once the detecting device is properly placed on the patient, the digital signal will experience much smaller amplitude changes, especially in the most significant bits of the digital signals. By comparing the most significant bits of the digital signals with a predetermined threshold, the firmware can identify when the detection device is correctly placed on the patient. That is, the detecting device is considered to be properly placed on the patient when the amplitude changes of the most significant bits become less than a predetermined threshold. Additionally or alternatively, the detection device may use input from a built-in motion sensor (eg, an accelerometer) to determine when the detection device is correctly placed on the patient.

[0054] After detecting the correct placement of the detecting device on the patient, the firmware may first transmit the entire measured signal (i.e., all 32 bits) to the receiver and subsequently transmit only a subset of bits (i.e., 12 least significant bits) to receiver until another triggering event is detected (eg removal of the detecting device). The receiver, in turn, can restore the full scale of data, without loss of information. Thus, less data is transmitted and the wireless communication between transmitter and receiver is improved. In the present disclosure, other types of sorting and filtering of measurement data are contemplated.

[0055] In another embodiment, the filtering performs dynamic sorting according to the dynamic tool protocol, wherein the firmware sorts the most relevant information and the least relevant information from the digital signals and transmits the processed signals. In another embodiment, the filtering performs a combined tool protocol, wherein the combined protocol comprises at least a combination of the previously mentioned protocols.

[0056] A tool for converting digital signals into digital volumetric signals, the units of the processed signals being the meter or its modifications, for example, micrometers, centimeters, nanometers, etc. In an embodiment, the instrument is a transducer, wherein the transducer converts the digital signals to digital volume change signals in the micrometer range.

[0057] In an embodiment, the detected analog signals are converted to digital signals and then converted by a digital to digital volume change conversion tool, wherein the processed signals comprise at least a measurement describing displacement due to volume change of the skull, as shown in FIG. 2.

[0058] A tool for modulating digital signals, digital volumetric signals, or analog signals for transmission by a transmitter. In an embodiment, there are different modulation tools for each of the different types of signals. In another embodiment, the tool is a modulation block, where the modulation block modulates at least one of a variety of signals.

[0059] In a further embodiment, the processor modulates said digital signals for transmission by a transmitter, wherein the modulated signals contain processed signals to be received by a preconfigured receiver.

[0060] In another embodiment, the processor modulates the received analog signals for transmission by the transmitter, wherein the modulated signals contain processed signals to be received by a preconfigured receiver.

[0061] Modulating a digital signal comprises at least modifying an incoming digital signal to transmit a digital signal to enable a transmitter to wirelessly communicate with a communication channel, such as a receiver, a pre-configured receiver, a network containing a band pass filter, or the like.

[0062] Modulating an analog signal consists of at least modifying an incoming analog signal to transmit an analog signal with a different frequency, phase, amplitude, quadrature, or angle to enable wireless communication of the transmitter with the communication channel.

[0063] A correction signal tool, wherein the processor detects signals represented by at least one correction sensor. In an embodiment, after detecting signals provided by at least one correction sensor, the processor processes the correction signal and adjusts the digital signals output from the detection device to generate a corrected digital signal related to the user's intracranial pressure, as shown in FIG. 3. In an embodiment, this tool is a correction block for detecting a correction signal.

[0064] The correction sensor is any device capable of detecting signals that are associated with the physiological parameters of the user, while the signals may interfere with the measurement of intracranial pressure, or detect signals that are associated with the operation of the detecting device. In an embodiment, the correction sensor is an environmental sensor, wherein the environmental sensor comprises at least a temperature sensor or a barometer or a hygrometer.

[0065] In another embodiment, the correction sensor is a motion sensor, wherein the motion sensor comprises at least a gyroscope or an accelerometer or a magnetometer. In another embodiment, the correction sensor is a global positioning system for geolocation. In another embodiment, the correction sensor is at least a motion sensor, an environmental sensor, a global positioning system, or a combination thereof.

[0066] In an embodiment, the signals detected by the at least one correction sensor, when processed by the correction signal tool, remove noise and interference from the signal detected by the detection device, for example, when the user changes the home position at which monitoring started, wherein the correction signal tool uses the signals detected by the at least one correction sensor to eliminate noise and interference that said change may cause.

[0067] In the step of transmitting the processed signals from the transmitter to the preset receiver, the processed signal is sent from the transmitter to the preset receiver via signals containing information regarding the user's intracranial pressure. In an embodiment, the wireless communication between the transmitter and the preset receiver is near field wireless communication. In another embodiment, the wireless communication between the transmitter and the pre-configured receiver is RF definition. In another embodiment, the transmitter communicates with a preconfigured receiver using the Bluetooth® standard protocol.

[0068] In an embodiment, the present method performs all steps of detecting analog signals, receiving, processing and transmitting these signals in real time, wherein said steps are performed continuously.

[0069] In a second aspect, the present invention provides a system for non-invasive treatment and monitoring of intracranial pressure, the system comprising:

a. a detecting device for detecting analog signals of changes in the volume of the skull;

b. a receiver in communication with the detecting device and receiving analog signals related to the user's intracranial pressure;

c. a processor comprising at least a tool for processing signals associated with the user's intracranial pressure, the processor being in communication with a receiver; And

d. a transmitter, wherein the transmitter is in communication with the processor and includes a module for wirelessly transmitting the processed signals.

[0070] In an embodiment, the system further comprises at least one preconfigured receiver. A preset receiver is any receiver that is in communication with a transmitter, wherein the preset receiver is configured to communicate with at least one electronic device to input the received processed signals to the electronic device for further processing the processed signal and transmitting said signal to cloud service.

[0071] The system further comprises a head for placing at least one device around the user's head. In an embodiment, the head portion is a narrow plate for accommodating at least the device around the user's head, comprising a fastener, wherein the fastener fits the narrow plate to the user's head. In a further embodiment, the narrow plate is flexible and fits around the user's head.

[0072] In an embodiment, the detecting device is a device for measuring changes in skull volume.

[0073] In a third aspect, the present invention provides a device for measuring skull volume change, comprising:

a. a change transducer (8) comprising a change detector provided with a first end configured to sense a deviation depending on a change in skull volume, the change transducer (8) converting the detected change into an electrical signal; And

b. housing, and the measuring transducer (8) changes is located inside the housing.

[0074] The change detector is any object capable of transmitting energy, determined as a result of a change in the volume of the skull, to the change transducer (8). In an embodiment, the change detector comprises a pin, said pin being connected to the change measuring transducer (8), the pin detecting the change and deforming said change measuring transducer (8) for conversion into an electrical signal.

[0075] In an embodiment, the change transducer (8) comprises an electrical circuit connected to the flexible material, wherein the deformation of the flexible material is detected by the electrical circuit.

[0076] The housing is any material or set of materials structurally arranged so as to protect the change transducer (8) and capable of containing said change transducer (8). In an embodiment, the housing comprises at least one enclosing portion around the change detector, wherein the enclosing portion protects the alteration detector from unnecessary movement.

[0077] In a further embodiment, the guard portion is positioned around the change detector, wherein the guard portion blocks movement of the change detector when the device is rotated and limits the maximum strain that the change transducer (8) can achieve.

[0078] The guard is any material within the housing that prevents erroneous movement of the change transducer (8) and provides protection from direct impact.

[0079] In an embodiment, the housing comprises a switch (5), a limit guard (6), and a locking device (7), wherein the locking device (7) locks the pin when the power is turned off to protect the device, and when the power is turned off , limiting guard (6) limits the deformation of the transducer (8) changes.

Example:

[0080] The examples provided in this application are intended only to illustrate one of several ways of using the present invention, but without limiting its scope.

[0081] The system for monitoring and treating intracranial pressure is non-invasive and designed to provide ease and convenience of use, strength and effectiveness. The system contains: low power architecture, defibrillation protection, built-in patient isolation, external biosensor circuitry for non-invasive transducer (8) changes, configurable three-color (RGB) LED, low power power management, long life battery, with lithium ion battery using internal battery (9) and external battery (15), internal fault monitors, advanced encryption standard hardware based on Embedded Arm Cortex-M4f processor, containing digital signal processor, tools with one an instruction stream and several data streams for processing signals related to the user's intracranial pressure, for example:

[0082] An analog-to-digital converter having a high accuracy and resolution architecture with a differential input, automatic gain control, automatic correction, low heating temperatures, zero drift and gain change.

[0083] A correction unit containing an internal temperature sensor, environmental sensors, for example, a temperature sensor, a humidity sensor, a pressure sensor, motion sensors, for example, an accelerometer, a gyroscope, a magnetometer, a location system sensor for geolocation.

[0084] Digital Signal Processing Instructions, Floating Point Unit (FPU), Single Cycle Multiply and Accumulate, Hardware Division for Power-Saving Computational Operations.

[0085] The firmware that performs all the functions protected by the hardware. Taking into account the low energy profile, the software and hardware provides the full operating principle with efficient energy consumption. All connections are optimized to consume less power. The non-volatile hardware memory contains all the information needed to automatically pair the device.

[0086] In an embodiment, the firmware filters said digital signals, the filtering using an event-based tool protocol, the firmware comprising a change detector for the most relevant information of the digital signals. Through the change detector, the firmware filters the signals based on the change of the most relevant information.

[0087] In another embodiment, the firmware filters said digital signals, the filtering using a dynamic tool protocol, the firmware comprising a sorter that sorts the most relevant information and the least relevant information of their digital signals.

[0088] In another embodiment, the firmware filters said digital signals, wherein the filtering uses a combination of the above protocols. In a further embodiment, the processor converts the digital signals to digital volume change signals, the digital volume change signals being measured in the micrometer range.

[0089] The system is powered by a long life battery, with a lithium ion battery and using an internal battery (9) and an external battery (15), while the external battery (15) is the primary power source for the system and recharges said internal battery (9), and when the external battery is recharged via the USB bus with a charge indicator, the internal battery (9) is used as the system's secondary power supply.

[0090] For data transmission, the system further comprises: wireless connectivity via wireless antenna (13), Bluetooth(5.0, near field wireless tag in-circuit, pre-configured receiver, secure authenticated pairing between two pre-configured devices, CPU, high bandwidth, advertising extensions, Bluetooth power saving mode (BLE), u.fl connector for external omnidirectional antenna.

[0091] In an embodiment, the system has a high priority in the stages of receiving, processing and transmitting signals to a pre-configured receiver connected to the central processing unit. Data transmission is dynamic, real-time, without loss of relevant data and with data encryption to prevent interception of collected signals.

[0092] The firmware update is performed via an application over the air. The system is initially configured with a bootloader that allows maintenance and repair of firmware.

[0093] The preset receiver has the function of recovering the analog ICP-dependent signal received by the preset receiver and feeding the signal to the monitor, application, or CPU.

[0094] In an embodiment, the system comprises a database with rules, functions, and pre-described methods implemented to facilitate access to reading and entering a new tool configuration. Tools, such as an analog-to-digital converter with a serial peripheral communication interface, contain a variety of groups of filter configurations, sample rates, automatic gain control, and automatic equalization. These tools can be called in read mode and perform processing in write mode, allowing remote dynamic configuration.

[0095] For further explanation of the embodiment, the device is shown in FIG. 5. In an embodiment, the housing comprises an upper protective piece (1) coupled to a lower base (3) to enclose and protect the components, with the lower base in contact with the user's skin when using the device.

[0096] In this embodiment, the processor containing the signal processing tools is the main sensor circuit board (2) and is in communication with the change transducer (8), with one of the auxiliary screws (10) acting as the device change detector. The measuring transducer (8) of the change is cantilevered on the base (4), while this base contains a circuit board of at least one correction sensor located on the base (4), acting as a correction unit connected by auxiliary screws (10) to the body , receives analog signals from the correction sensors and communicates with the circuit board (2) of the main sensor in order to process intracranial pressure with greater accuracy, or to transmit the received analog signals from at least one correction sensor.

[0097] In an embodiment, the locking device is provided with a first end containing a trigger element (7.1) and a second end opposite the first end and containing an opening (7.2), while the opening (7.2) is configured to interface with a change detector. In an embodiment, the hole (7.2) mates with the pin, with the pin having a gap to mate with the hole (7.2) between two raised lugs near it to block movement perpendicular to the hole (7.2) and pin mate. In an embodiment, the hole (7.2) mates with the pin, with the pin having a gap to mate with the hole (7.2) above the raised lip to block pin movement that could deform the change transducer (8). In an embodiment, a hole (7.2) mates with a pin, whereby the pin and hole have circular perimeters, but the pin has a larger diameter than the hole (7.2) and, when mated, friction interferes with movement perpendicular to the hole (7.2) and pin mate .

[0098] In an embodiment, the boundary fence (6) is located opposite the first end of the change detector, and the boundary fence (6) contains a restrictive element (6.1). In an additional embodiment, the housing contains a safety gap between the boundary fence (6) and the change transducer (8), while the safety gap ensures safe deformation of the change transducer (8).

[0099] In the embodiment, the switch (5) contains a hole (5.1) of the trigger element, formed with the possibility of pairing with the trigger element (7.1), while the trigger element (7.1) is located inside the hole (5.1) of the trigger element, and the said switch ( 5) has an offset limited by the limiting element (6.1).

[0100] The internal battery (9) is inside the housing. Screws (11) secure the system to allow connection of each component, and the support part (12) is located above the circuit board of at least one correction sensor located on the base (4). The wireless antenna (13) acts as the transmitter of the system, is located inside the housing, communicates with the circuit board (2) of the main sensor and transmits the processed signals to a pre-configured receiver.

[0101] The outer protective piece (14) covers the upper protective piece (1) for protection together with the upper protective piece (1) of the external battery (15) attached to the upper protective piece (1). The spring (16) connected to the mating closures (19) and in combination with the connecting closures (17) is capable of securing and releasing the external battery (15) to the housing. The battery connectors (18) attached to the circuit board (2) of the main sensor provide communication between the external battery (9) and the circuit board (2) of the main sensor. The lower protective piece (20) located between the circuit board (2) of the main sensor and the upper protective piece (1) protects the circuit board (2) of the main sensor from direct impact.

[0102] In another exemplary embodiment, the method is performed as shown in FIG. 1, a change in the volume of the user's skull causes the pin of the detection device to deflect. The pin transmits deflection to deform the change transducer generating a differential voltage signal related to the user's intracranial pressure.

[0103] This signal is analog and is received by the receiver and then sent to the processor to convert the analog signal to a digital signal. In this example, the processor uses the ADC tool for this conversion. The digital signal is modulated to form a processed signal ready for transmission by the transmitter. The transmitter transmits the processed signal wirelessly to a preconfigured receiver.

[0104] In another exemplary embodiment, the method is performed as shown in FIG. 2, a change in the volume of the user's skull causes the pin of the detection device to deflect. The pin transmits deflection to deform the change transducer generating a differential voltage signal related to the user's intracranial pressure.

[0105] This signal is analog and is received by the receiver and then sent to the processor to convert the analog signal to a digital signal and to amplify said digital signal. In this example, the processor uses the ADC tool for this conversion. The processor then executes another tool to convert the digital signals to digital volume change signals in the micrometer range. The digital volume change signals are modulated for transmission by the transmitter. The transmitter then wirelessly transmits the digital volume changes to a preconfigured receiver.

[0106] In another exemplary embodiment, the method is performed as shown in FIG. 3. A change in the volume of the user's skull causes the pin of the detecting device to deviate. The pin transmits deflection to deform the change transducer generating a differential voltage signal related to the user's intracranial pressure.

[0107] In parallel with the detection of a change in the volume of the skull, a plurality of environmental sensors and an inertial sensor register pressure, humidity, temperature, acceleration, geolocation, and magnetic field and transmit these signals to the processor.

[0108] The differential voltage signal is analog and is received by the receiver, then sent to the processor to convert the analog signal to a digital signal and to amplify said digital signal. The processor further processes the digital signal using a converter tool to convert the digital signals into a digital volume change signal in the micrometer range. The processor correction tool then processes the digital volume change signal and the signals recorded by the plurality of environmental sensors and the inertial sensor to generate a correction signal that removes noise caused by user movement or other user monitoring decompensation, such as user movement from a sunny location to a location. under the roof, with signal processing detecting a temperature change influencing the physical change that may be caused by that temperature change. The correction signal is modulated for transmission by the transmitter. The transmitter then wirelessly transmits the correction signal to the preconfigured receiver.

[0109] Specialists in the art will appreciate the information provided in this application, and will be able to reproduce the invention in the proposed manner and in other ways, not departing from the scope of the attached claims.

Claims (55)

1. A method for non-invasive monitoring of intracranial pressure, which includes the following steps: detecting analog signals from the user by means of a detecting device located on the user's head and detecting a change in skull volume, the detecting device being provided with a change sensor; receiving the detected analog signals by a receiver, each of the detected analog signals being associated with the user's intracranial pressure; characterized in that it includes the steps: processing by the processor of the detected analog signals, generating processed signals, the processing comprising converting by the processor of the detected analog signals into digital signals related to the intracranial pressure of the user; wherein the processor comprises a digital signal filtering tool, wherein the filtering tool is firmware that filters a subset of the least significant bits of the digital signals, said filtering step comprising: event-based sorting, wherein the software identifies a trigger event based on the digital signals, wherein the trigger event is a change in the digital signals; moreover, the software determines the correct placement of the detecting device on the user's head at the stages: i. comparison by software during initial setup of the most significant bits of the digital signal with a predetermined threshold value to determine when the detecting device has been properly mounted on the user's head; And ii. initially transmitting by the transmitter, in accordance with the software, the entire digital signal, and then transmitting only the least significant bits until the software detects the removal of the detecting device; And transmitting the processed signals containing only the least significant bits by means of a transmitter to a pre-configured receiver, wherein the transmitter and pre-configured receiver are in wireless communication; moreover, the processed signals containing only the least significant bits are transmitted until another trigger event is detected, and the pre-configured receiver is configured to recover the entire digital signal; however, after the software detects another trigger event, the entire digital signal is transmitted by the transmitter to the preconfigured receiver. 2. The method according to claim 1, characterized in that the processor further comprises the following: a tool for converting digital voltage signals into digital signals of changes in the volume of the skull; a tool for modulating digital signals for transmission by a transmitter; a tool for modulating digital signals of skull volume changes for transmission by a transmitter; a tool for modulating analog signals for transmission by a transmitter; a compensating signal, wherein the processor detects signals represented by at least one correction sensor; And their combinations. 3. The method of claim 1, wherein the software filtering further includes a dynamic sorting step in which the software sorts the least significant bits and most significant bits from the digital signals and transmits the processed signals. 4. Method according to claim 2, characterized in that at least one correction sensor is at least one of the following: an ambient sensor, the ambient sensor comprising at least a temperature sensor or a barometer or a hygrometer; a motion sensor, the motion sensor comprising at least a gyroscope or an accelerometer or a magnetometer; And global positioning system for geolocation. 5. The method according to claim. 2, characterized in that the conversion of digital signals into digital signals of the change in the volume of the skull includes at least a measurement describing the displacement as a result of the change in the volume of the skull. 6. The method according to claim. 1, characterized in that the step of detecting analog signals from the user by means of a detecting device includes detecting a change in the volume of the skull, while the change in the volume of the skull causes a deviation of the pin, which transmits this deviation, to deform the change transducer, and the transducer changes generates a differential voltage signal related to the user's intracranial pressure. 7. The method according to claim. 1, characterized in that the steps are performed in real time. 8. A system for non-invasive monitoring of intracranial pressure, comprising: a detection device located on the user's head for detecting analog signals from a change in skull volume, the detection device being provided with a change sensor; a receiver that communicates with the detecting device and receives the detected analog signals generated by the sensor changes associated with the user's intracranial pressure, characterized in that it contains: a processor comprising at least a tool for processing detected analog signals related to the user's intracranial pressure, wherein the processor is in communication with a receiver, the tool for processing analog signals related to the user's intracranial pressure comprises an analog-to-digital converter, and firmware, wherein the firmware filters a subset of the least significant bits of the digital signals, wherein the software includes an event-based detection protocol, and the software includes a change detector and identifies a trigger event based on digital signals; wherein the trigger event is a change in the digital signals; at the same time, the software detects the correct placement of the detecting device on the user's head, while: i. during the initial setup, the software compares the most significant bits of the digital signal with a pre-set threshold to determine when the detection device has been correctly placed on the user's head; And ii. after the transmission of the entire digital signal, the software filters only the least significant bits for transmission until the removal of the detecting device is detected; And a transmitter in communication with the processor and containing a module for wirelessly transmitting the processed signals to a pre-configured receiver, the processed signals containing only the least significant bits, and the pre-configured receiver is configured to recover the entire digital signal; while the processed signals containing only the least significant bits are transmitted until another trigger event is detected, performed by the event-based tool protocol; moreover, after the software detects another trigger event, the entire digital signal is transmitted by the transmitter to the preconfigured receiver. 9. The system according to claim. 8, characterized in that the means for processing signals related to the intracranial pressure of the user further comprises at least one of the following: a transducer, wherein the transducer converts digital voltage signals into digital displacement signals associated with a change in skull volume; modulating unit, wherein the modulating unit modulates at least one of the following: - digital voltage signals for transmission by the transmitter, - digital displacement signals with a change in the volume of the skull for transmission by a transmitter or - analog signals for transmission by the transmitter; their combinations. 10. The system of claim 8, wherein the software further comprises a dynamic instrument protocol, wherein the software comprises a sorter that sorts the least significant bits and most significant bits from the digital signals. 11. The system according to claim 8, characterized in that the detecting device comprises at least one correction sensor in communication with a tool for processing signals related to the user's intracranial pressure, and the tool for processing signals related to the user's intracranial pressure , contains a compensation unit communicated with the correction sensor, and the correction sensor is a temperature sensor. 12. The system according to claim. 11, characterized in that at least one correction sensor contains at least one of the following: an ambient sensor, the ambient sensor comprising at least a temperature sensor or a barometer or a hygrometer; a motion sensor, the motion sensor comprising at least a gyroscope or an accelerometer or a magnetometer; And global positioning system for geolocation. 13. The system according to claim 8, characterized in that the detecting device contains: a change transducer comprising a change detector provided with a first end capable of sensing a deviation dependent on a change in cranial volume, the change transducer converting the detected change into an electrical signal; And housing, and the change transducer is located inside the housing. 14. The system of claim. 8, characterized in that it further comprises at least one preset receiver, while the transmitter communicates with at least one preset receiver. 15. The system according to claim 8, characterized in that it is configured to perform the method of non-invasive monitoring of intracranial pressure according to claim 1.

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