Methods and systems for non-invasive management and monitoring of intracranial pressure, and devices for measuring changes in cranial volume.

Abstract

To provide a device for measuring a change in an intracranial volume.SOLUTION: Provided is a device for measuring a change in an intracranial volume. The device includes a. a change transducer that includes a change detector provided with a first end portion configured to receive flexure related to a change in an intracranial volume, and converts the detected change into an electric signal, and b. a housing that stores therein the change transducer.SELECTED DRAWING: Figure 4

Description

Technical Field

[0001] Cross - reference to related applications This application claims the benefit and priority of Brazilian Patent Application No. 1020170238792, filed on November 6, 2017. The entire disclosure of the above application is incorporated herein by reference.

[0002] The present invention describes methods and systems for non - invasive management and monitoring of cranial volume changes, as well as devices for measuring cranial volume changes. Specifically, it includes detecting cranial volume changes by an analog signal and processing this signal to transmit it to another electronic device or a cloud server. The present invention belongs to the fields of medicine, biomedicine, neuroscience, physical quantity measurement, and electrical engineering.

Background Art

[0003] In most human organs, the ambient pressure against blood perfusion is below atmospheric pressure. However, in the central nervous system, including the brain and spinal cord, due to the protection by the cranial cavity and spinal canal, the ambient pressure is different. This pressure is referred to as intracranial pressure.

[0004] Intracranial pressure (ICP) is one of the major physiological parameters of animals and humans, and its morphology is extremely important. However, the conventional methods for detecting, monitoring, and managing a user's intracranial pressure are almost invasive. In contrast, non - invasive is required as an advanced technology. Therefore, the scope of the research field regarding this important neurological parameter, which has not been advanced because invasive methods have been adopted for intracranial pressure, is expanded.

[0005] For example, it is well known that changes in the heart and other complex parameters can predict a patient's clinical condition and the occurrence of fatal conditions. For patients with neurological risks, analysis of the correlation between intracranial pressure and arterial pressure can provide information about the brain's autoregulatory function. This information is crucial for the decision-making process regarding the selection of the best treatment to apply. However, in practice, this analysis is rarely performed to generate information relevant to hospital staff.

[0006] Currently, monitoring the physiological parameters of patients in intensive care units generates a vast amount of data for decision-making processes. However, this data is generally not effectively utilized by hospital staff. Current tools, such as alarm protocols for multi-parameter monitors that are triggered by deviations from standard patterns of physiological parameters, are undoubtedly more inconvenient than beneficial. Less than 10% of alarms issued in the ICU are clinically relevant. In the United States, it is estimated that 28% of diagnoses in the ICU are wrong, and 8% of those are fatal. In pediatric ICUs, 19.6% of diagnoses are wrong, and 4.5% of those are fatal. As a result, more than 40,000 people die each year in US ICUs due to misdiagnosis.

[0007] To optimize treatment protocols, improve patients' quality of life, and reduce misdiagnosis and hospital costs, there is a need to provide healthcare professionals with better diagnostic tools to deliver information relevant to the patient's clinical condition and contribute to the decision-making process. Conventional intracranial pressure monitoring methods involve perforation of the skull and insertion of a catheter to measure ICP. This procedure is invasive and carries the risk of worsening cerebral edema, parenchymal damage, intracranial hemorrhage, and intracranial infection. The last one is the most likely to occur. Considering all the aforementioned drawbacks, one of the important needs is to monitor intracranial pressure in a non-invasive way that does not involve the complications that occur in the case of skull perforation. This will open up a new field of research on this important physiological parameter that has been understudied due to the adoption of invasive monitoring methods. Furthermore, the development of non-invasive monitoring methods will simultaneously enhance the usefulness of invasive methods, as confirmation is required for monitoring absolute intracranial pressure.

[0008] Further advanced technology requires a system that wirelessly monitors intracranial pressure. This system would be highly convenient in a variety of different situations.

[0009] Through a search of technical and patent documents, the following were identified as relevant documents for the present invention.

[0010] International Publication No. 2013041973A2 discloses a system for non-invasive measurement and monitoring of intracranial pressure. The system monitors intracranial pressure via a wired connection. Therefore, it is difficult to apply this system to a variety of situations. Furthermore, the system may be damaged during transport.

[0011] Chinese Published Patent No. 106618490A discloses a minimally invasive system for detecting a patient's body temperature and intracranial pressure using different processing methods. In this system, signals are transmitted wirelessly. However, even though it is a minimally invasive system, it still requires insertion into the patient's body, making it too risky to use in certain situations or on an as-needed basis. Furthermore, Chinese Published Patent No. 106618490A transmits a large amount of unnecessary data to the receiver. Therefore, this minimally invasive system requires appropriate means to handle high-traffic information flows. Consequently, the system and processing become impractical for users.

[0012] The specification of Chinese utility model application No. 202458347U describes a system for indirectly monitoring intracranial pressure. The document also describes a method for detecting multiple physiological parameters. By processing these multiple parameters, the patient's intracranial pressure is determined. This system requires the detection of multiple parameters and does not directly detect intracranial pressure. This is because the applicant emphasizes that the system detects the patient's blood pressure, electrocardiogram, electroencephalogram, bioelectrical impedance, and oxygen, and derives conclusions about the patient's intracranial pressure from these.

[0013] The Chinese published patent specification No. 106361320A describes a minimally invasive system for monitoring intracranial pressure. Because the sensor is placed directly into the patient's skull, a craniotomy is required. Therefore, this specification cannot be used to perform intracranial pressure monitoring as needed by the patient. This method provides an invasive procedure for collecting information about the patient's health.

[0014] As can be inferred from the literature, nothing suggests or assumes the teachings of the present invention. Therefore, the methods proposed herein possess novelty and inventiveness not found in the advanced art. [Prior art documents] [Patent Documents]

[0015] [Patent Document 1] International Publication No. 2013041973A2 Pamphlet [Patent Document 2] Chinese Published Patent No. 106618490A Specification [Patent Document 3] Chinese Utility Model Application No. 202458347U Specification [Patent Document 4] Chinese Published Patent No. 106361320A Specification [Overview of the project]

[0016] This invention solves technical problems of advanced technology by providing a system and method for the non-invasive management and monitoring of intracranial pressure, as well as a device for measuring changes in cranial volume. Specifically, the invention includes detecting and receiving an analog signal of a user's cranial volume change, processing the signal, and transmitting the processed signal wirelessly to a pre-configured receiver. The proposed method enables the non-invasive detection of a user's cranial deformation and accurate monitoring of intracranial pressure.

[0017] Therefore, in one aspect, the present invention provides a method for non-invasive management and monitoring of intracranial pressure. This method is a. A step of detecting an analog signal from the user using a detection device. b. The receiver receives an analog signal related to the intracranial pressure of each detected user, c. A step of processing the detected analog signal with a processor to generate a processed signal, d. The step of transmitting the processed signal to a pre-configured receiver via the transmitter, The transmitter and pre-configured receiver communicate wirelessly.

[0018] In a second aspect, the present invention provides a system for the non-invasive management and monitoring of intracranial pressure. This system is a. A detection device for detecting analog signals from changes in cranial volume, b. A receiver that communicates with the detection device and receives an analog signal related to the intracranial pressure of the user; c. A processor that communicates with the receiver and includes tools for processing at least a signal related to the intracranial pressure of the user; d. A transmitter that communicates with the processor and includes a module for wirelessly transmitting the processed signal. It is provided with the above.

[0019] In a third aspect, the present invention provides a device for measuring cranial volume changes. The device a. Includes a change detector provided with a first end configured to receive deflection related to cranial volume changes, and a change transducer (8) that converts the detected changes into electrical signals; b. A housing that houses the change transducer (8) inside. It is provided with the above.

[0020] The above and other aspects of the present invention will be immediately understood by those skilled in the art and enterprises interested in the product state, and will be described in sufficient detail in the following description to be reproducible.

[0021] The examples shown in this specification are only intended to illustrate only some of the ways to implement the present invention and do not limit its scope.

Brief Description of the Drawings

[0022] [Figure 1] A flowchart of an embodiment of the present invention for non-invasive management and monitoring of cranial volume changes is shown. Using volts as the unit of measurement, the analog signal detected to indicate the signal of cranial volume change is processed. [Figure 2] A flowchart of another embodiment of the present invention for non-invasive management and monitoring of cranial volume changes is shown. Using micrometers as the unit of measurement, the detected analog signal is further processed to indicate the signal of cranial volume change. [Figure 3]A flowchart of another embodiment of the present invention for non-invasive management and monitoring of cranial volume changes is shown. Multiple detection analog signals are processed to show signals of cranial volume changes with micrometers as the unit of measurement, and to remove environmental noise in the analog signals associated with the user's ICP. [Figure 4] A schematic diagram of one of the system's embodiments is shown to illustrate the system's performance. [Figure 5] An exploded view of an embodiment of the present invention for non-invasive detection and monitoring of changes in cranial volume is shown. [Figure 6] An exploded view of an embodiment of the present invention for non-invasive detection and monitoring of changes in cranial volume is shown. [Figure 7] Figure 5 shows an exploded view of an embodiment of the present invention for non-invasive detection and monitoring of changes in cranial volume, and an enlarged view of Figure 5 is shown to further clarify the embodiment. [Figure 8] An embodiment of a device for measuring changes in cranial volume is shown. [Figure 9] A diagram illustrating an embodiment of a system for the non-invasive management and monitoring of cranial volume changes is shown. [Figure 10] A diagram illustrating an embodiment of a system for the non-invasive management and monitoring of cranial volume changes is shown. [Figure 11] A diagram illustrating an embodiment of a system for the non-invasive management and monitoring of cranial volume changes is shown. [Figure 12] A diagram illustrating an embodiment of a system for the non-invasive management and monitoring of cranial volume changes is shown. [Figure 13] A diagram shows an embodiment of a system for the non-invasive management and monitoring of cranial volume changes, positioned around the user's head. [Figure 14] A diagram shows an embodiment of a system for the non-invasive management and monitoring of cranial volume changes, positioned around the user's head. [Figure 15] A diagram shows an embodiment of a system for the non-invasive management and monitoring of cranial volume changes, positioned around the user's head. [Figure 16]A diagram shows an embodiment of a system for the non-invasive management and monitoring of cranial volume changes, positioned around the user's head. [Figure 17] A diagram shows an embodiment of a system for the non-invasive management and monitoring of cranial volume changes, positioned around the user's head. [Figure 18] A diagram shows another embodiment of a system for non-invasive management and monitoring of cranial volume changes, positioned around the user's head. [Figure 19] A diagram shows another embodiment of a system for non-invasive management and monitoring of cranial volume changes, positioned around the user's head. [Figure 20] A diagram shows another embodiment of a system for non-invasive management and monitoring of cranial volume changes, positioned around the user's head. [Figure 21] This shows the circulation of cerebrospinal fluid in the central nervous system. [Figure 22] The graph shows the Langfitt curve. The y-axis represents intracranial pressure, and the x-axis represents cranial volume. [Figure 23] This graph shows intracranial pressure over time. The upper curve indicates a state of good autoregulation, while the lower curve indicates a state of impaired autoregulation. [Figure 24] This graph shows the Lundberg curve A (plateau), which illustrates intracranial pressure over time. [Figure 25] This graph shows the Lundberg curve B (pulse wave) indicating intracranial pressure over time. [Modes for carrying out the invention]

[0023] Intracranial pressure is normally less than 10 to 15 mmHg in adults, and the cranial contents are protected by the skull, a rigid structure with an internal volume of 1400 to 1700 ml. Under normal conditions, cranial contents include brain parenchyma (80 to 85 volume percent), cerebrospinal fluid (5 to 10 volume percent), and blood (8 to 12 volume percent).

[0024] Cerebrospinal fluid (CSF) is a colorless aqueous fluid containing small amounts of protein, potassium, glucose, and sodium chloride, which occupy the subarachnoid and ventricular spaces. The primary function of CSF is to protect the central nervous system, distributing pressure according to Pascal's principle, as shown in Figure 21. The pressure is distributed in all directions within the skull. In the figure, arrows indicate the direction of fluid flow. Therefore, by immersing the central nervous system in this fluid, CSF acts as a buffer system for the CSF, reducing the risk of cerebral injury from direct contact with the skull. As the volume of brain parenchyma or blood vessels increases, this fluid is drained, reducing intracranial pressure to a certain lower limit. In this way, the volume within the skull is regulated.

[0025] From a neurological perspective, one of the most important features of the cranial cavity is that it is a completely closed cavity. This means that volume changes do not become large, but occur to an extent detectable by the methods, systems, and devices proposed in this invention. An increase in the volume of one component propagates to other components, resulting in an increase in intracranial pressure. This is illustrated in Figure 22, where the X-axis represents volume and the Y-axis represents ICP. Tumors, birthmarks, and other intracranial expansion phenomena compress not only the affected area but also all structures within the cranial cavity.

[0026] A typical ICP curve is shown in Figure 23. This is a transformed arterial pulse wave and consists of three distinct peaks. P1 is called the percussion wave and is due to arterial pressure transmitted from the choroid plexus. P2 is called the tidal wave and is the reverberation of P1, which changes in response to the brain's autoregulatory function. P3 is called the dicrotic wave and occurs prior to the closure of the aortic valve.

[0027] When intracranial pressure monitoring is recorded over a long period, distinct features can be observed in several wave curves. Lundberg waves can be divided into three types. As shown in Figure 24, curve A (plateau) always indicates a pathological state. That is, intracranial pressure increases by 100 mmHg over 2 to 20 minutes and then suddenly drops to the baseline. This is presumed to indicate cerebral vasodilation and is interpreted as a significant signal indicating intracranial pressure decompensation. As shown in Figure 25, curve B (pulse) consists of pulse waves with amplitudes of up to 50 mmHg occurring 0.5 to 2 times per minute, reflecting the effect of the respiratory cycle on intracranial pressure. These signals are seen in normal individuals, but amplitudes exceeding 10 mmHg indicate intracranial lesions. Curves A and B are warning signals indicating potential impairment of autoregulation. Curve C occurs 4 to 8 times per minute and is related to the Traube-Henring-Meier arterial curve.

[0028] Monitoring intracranial pressure allows for the measurement of pressure and analysis of its waveform, providing crucial information about intracranial dynamics and the brain's self-regulatory function. Analysis of intracranial pressure provides information to identify users with low adaptive capacity (weak self-regulatory function) who are susceptible to the effects of elevated intracranial pressure and decreased cerebral perfusion pressure.

[0029] Therefore, in one aspect, the present invention provides a method for non-invasive management and monitoring of intracranial pressure. This method is a. A step of detecting an analog signal from the user using a detection device, b. The receiver receives an analog signal related to the intracranial pressure of each detected user, c. A step of processing the detected analog signal with a processor to generate a processed signal, d. The process includes transmitting the processed signal to a pre-configured receiver via a transmitter, wherein the transmitter and the pre-configured receiver communicate wirelessly.

[0030] In this invention, the term "user" refers to a human or animal capable of detecting changes in cranial volume by the system.

[0031] The step of detecting an analog signal from the user includes detecting changes in cranial volume and / or cranial deformation, which impart a positive or negative deflection to the pin. If a variable transducer (8) is connected to the pin, the deflection deforms the variable transducer (8), thereby causing the variable transducer (8) to generate a differential voltage signal related to the user's intracranial pressure. This differential voltage signal is received by the receiver, and signal processing begins.

[0032] In one embodiment, the signal detected from the variable transducer (8) is transmitted to a receiver that communicates with the processor.

[0033] The step of receiving the detected analog signal by a receiver includes the ability to receive any analog signal transmitted by the detection device, without being restricted to any method performed by the detection device. In this step, the detected analog signal passes through an electronic circuit capable of generating processor-readable electronic information. In one embodiment, the received analog signal is detected by a pressure sensor, mechanical sensor, induction sensor, liquid crystal sensor, laser sensor, strain gauge sensor, optical sensor, or a combination thereof.

[0034] In another embodiment, the receiver is equipped with the ability to receive multiple analog signals. The receiver can receive multiple signals via serial or parallel communication. In one embodiment, the multiple analog signals may be, but are not limited to, signals relating to temperature, ambient pressure, humidity, orientation, angular velocity, acceleration, magnetism, and geolocation information.

[0035] The processing steps performed by the processor define the type of processor and the tools required for those processing steps. The processor includes at least one tool for processing the analog signals described above. This tool is described below.

[0036] A tool for converting detected analog signals into digital signals related to the user's intracranial pressure without compromising the effectiveness of intracranial pressure monitoring. In one embodiment, this tool is an AD converter.

[0037] In one embodiment, the processor uses one of its tools to process signals related to the user's intracranial pressure, converting the detected signals into digital signals. Other tools are then used to amplify these signals and obtain the processed signals. The processed signals are then wirelessly transmitted by a transmitter. Figure 1 illustrates the conversion without further processing steps by other tools.

[0038] A tool for filtering digital signals for transmission by a transmitter. This filtering is performed by firmware to filter out the most relevant information from the digital signal. In one embodiment, the tool is a filter, which performs the filtering of digital signals for transmission by a transmitter.

[0039] In one embodiment, filtering performs event-based classification via an event-based tool protocol. The firmware identifies the most relevant information changes in the digital signal and transmits the processed signal.

[0040] In one exemplary embodiment, an analog signal from a detection device is converted to a digital signal using an AD converter with, for example, 32-bit resolution. When the detection device is properly positioned on the patient, it is assumed that changes in the measurement occur in only a subset of bits (e.g., 12 least significant bits). To improve wireless communication, the firmware transmits the most relevant information (i.e., a subset of the least significant bits) while filtering out less relevant information (e.g., the remaining higher bits).

[0041] During device initialization, the firmware analyzes the entire digital signal to identify trigger events. One exemplary event is detecting proper placement of the detection device to a patient. During device initialization, the detection device is moved, and the amplitude of the digital signal changes significantly. On the other hand, when the detection device is properly placed to a patient, the change in the amplitude of the digital signal is drastically reduced, particularly in the most significant bit of the digital signal. By comparing the most significant bit of the digital signal to a predetermined threshold, the firmware can determine when the detection device is properly placed to the patient. That is, the detection device is considered to be properly placed to the patient if the change in the amplitude of the most significant bit is below a predetermined threshold. Furthermore / or, the detection device may use input from an integrated motion sensor (e.g., an accelerometer) to determine when the detection device is properly placed to the patient.

[0042] Once the detection device detects that it is properly positioned on the patient, the firmware first sends the entire measurement signal (i.e., all 32 bits) to the receiver, and then sends only a subset of the bits (i.e., the 12 least significant bits) to the receiver until another trigger event (e.g., removal of the detection device) is detected. The receiver can then completely reconstruct the date without any information being lost. This reduces the amount of data transmitted and improves wireless communication between the transmitter and receiver. Other types of classification and filtering of measurement data are possible in this disclosure.

[0043] In another embodiment, filtering performs dynamic sorting through a tool dynamic protocol. That is, the firmware classifies the most relevant and least relevant information from the digital signal and transmits the processed signal. In another embodiment, filtering performs a tool combination protocol. The combination protocol includes at least a combination of each of the protocols described above.

[0044] A tool for converting a digital signal into a digital signal of volume change. The unit of measurement for the processed signal is meters or similar units (e.g., micrometers, centimeters, nanometers, etc.). In one embodiment, this tool is a converter that converts a digital signal into a digital signal of volume change in the micrometer range.

[0045] In one embodiment, the detected analog signal is converted to a digital signal, which is then converted by a tool that converts the digital signal to a digital signal of volume change. The processed signal includes at least the measured values ​​representing the variation in cranial volume change. This is shown in Figure 2.

[0046] A tool for modulating digital signals, volume-changing digital signals, or analog signals for transmission by a transmitter. In one embodiment, each of different types of signals is modulated by a different tool. In another embodiment, the tool becomes a modulation unit that modulates at least one of different types of signals.

[0047] In a further embodiment, the processor modulates these digital signals for transmission by a transmitter. This modulated signal becomes the processed signal received by a pre-configured receiver.

[0048] In another embodiment, the processor modulates the analog signal received for transmission by the transmitter. This modulated signal becomes the processed signal received by the pre-configured receiver.

[0049] Modulation of a digital signal includes at least modifying an incoming digital signal for transmission in order to enable wireless communication between a transmitter and a communication channel (e.g., a network including a receiver, a pre-configured receiver, and a bandpass filter).

[0050] Modulation of an analog signal consists of at least altering an incoming analog signal to transmit it at different frequencies, phases, amplitudes, perpendicular phases, or angles, enabling wireless communication between a transmitter and a communication channel.

[0051] A tool for compensation signals. The processor detects a signal provided by at least one compensation sensor. In one embodiment, as shown in Figure 3, after detecting a signal provided by at least one compensation sensor, the processor processes the compensation signal, adjusts the digital signal emitted from the detection device, and generates a compensation digital signal related to the user's intracranial pressure. In one embodiment, the tool is a compensation unit for detecting the compensation signal.

[0052] The correction sensor is any device capable of detecting signals related to the user's physiological parameters that may interfere with intracranial pressure measurement, or detection signals related to the function of the detection device. In one embodiment, the correction sensor is an environmental sensor, which includes at least a temperature sensor, or a barometer, or a hygrometer.

[0053] In another embodiment, the correction sensor is a motion sensor, which includes at least a gyroscope, or an accelerometer, or a magnetometer. In another embodiment, the correction sensor is a global positioning system for geolocation. In yet another embodiment, the correction sensor is at least a motion sensor, an environmental sensor, a global positioning system, or a combination thereof.

[0054] In one embodiment, the signal detected by at least one compensation sensor is processed by a tool for the compensation signal to remove noise and interference from the signal detected by the detection device. For example, if the user changes the initial position in which the tool began monitoring, the tool for the compensation signal utilizes the signal detected by at least one compensation sensor to remove any noise and interference that may result from this change.

[0055] In the step of transmitting the processed signal to the pre-configured receiver via the transmitter, the processed signal is transferred from the transmitter to the pre-configured receiver via a signal containing information about the user's intracranial pressure. In one embodiment, the wireless communication between the transmitter and the pre-configured receiver is short-range wireless communication. In another embodiment, the wireless communication between the transmitter and the pre-configured receiver is RFID. In another embodiment, the transmitter communicates with the pre-configured receiver by the Bluetooth® standard protocol.

[0056] In one embodiment, the method performs all of the steps of detecting analog signals and processing and transmitting these signals in real time, and these steps are performed without interruption.

[0057] In a second aspect, the present invention provides a system for the non-invasive management and monitoring of intracranial pressure. This system is a. A detection device for detecting analog signals from changes in cranial volume, b. A receiver that communicates with a detection device and receives an analog signal related to the user's intracranial pressure, c. A processor that communicates with a receiver, which includes tools for processing signals related to the user's intracranial pressure, d. A transmitter including a module for communicating with the processor and wirelessly transmitting the processed signal, It is equipped with.

[0058] In one embodiment, the system further includes at least one pre-configured receiver, which is any receiver that communicates with the transmitter. The pre-configured receiver is configured to communicate with at least one electronic device and insert the received processed signal into the electronic device. There the processed signal is further processed and transmitted to a cloud server.

[0059] The system further includes a headpiece for accommodating at least one device around the user's head. In one embodiment, the headpiece is a strip for attaching the device around at least the user's head, the strip having a fastener that adjusts the strip over the user's head. In a further embodiment, the strip is flexible and attaches around the user's head on its own.

[0060] In one embodiment, the detection device is a device for measuring changes in cranial volume.

[0061] In a third aspect, the present invention provides a device for measuring changes in cranial volume. The device is a. A change detector comprising a first end configured to receive deflections related to changes in cranial volume, and a change transducer (8) that converts the detected changes into electrical signals, b. A housing that houses the variable transducer (8) inside, It is equipped with.

[0062] A change detector is any object capable of transmitting energy detected from changes in cranial volume to a change transducer (8). In one embodiment, the change detector includes a pin, which is connected to a change transducer (8), and the pin detects the change and generates a deformation in the change transducer (8) for conversion into an electrical signal.

[0063] In one embodiment, the variable transducer (8) includes an electrical circuit connected to a flexible material, and the deformation of the flexible material is detected by the electrical circuit.

[0064] The housing is positioned as a design feature to protect the change transducer (8) and is made of any material or set of materials capable of housing the change transducer (8). In one embodiment, the housing includes at least one enclosure portion around the change detector, the enclosure portion protecting the change detector from unwanted movement.

[0065] In a further embodiment, the enclosure portion is positioned around the change detector, and the enclosure portion stops the movement of the change detector when the device is turned off, and defines the maximum possible deformation range of the change transducer (8).

[0066] The enclosure portion is any material within the housing that prevents the variable transducer (8) from moving unintentionally and protects it from direct impact.

[0067] In one embodiment, the enclosure comprises a switch (5), a range-defining enclosure (6), and a locking device (7). The locking device (7) includes locking a pin when the power is off for device protection. When the power is off, the range-defining enclosure (6) defines the deformable range of the variable transducer (8). [Examples]

[0068] The examples provided herein are intended to illustrate only one of several ways in which the present invention can be carried out, but are not intended to limit its scope.

[0069] The system for monitoring and managing intracranial pressure is non-invasive, and its purpose is to be simple, easy to use, robust, and efficient. The system features a low-energy structure, defibrillation protection, a built-in patient isolation device, a front-end biosensing circuit for a non-invasive change transducer (8), configurable RGB LEDs for specific indicators, low-energy power management, long-life lithium battery life with an internal battery (9) and an external battery (15), an internal fault monitoring device, and advanced encryption standard hardware based on an embedded processor Arm Cortex-M4F including a digital signal processor, and single-instruction multiplexing data. Furthermore, it includes tools for processing the following intracranial pressure-related signals:

[0070] It is an AD converter with a high-precision and high-resolution architecture featuring differential input, automatic gain, automatic offset, low temperature, and offset and gain drift.

[0071] A compensation unit equipped with an internal temperature sensor, environmental sensors (temperature sensor, humidity sensor, pressure sensor, etc.), motion sensors such as an accelerometer, gyroscope, and magnetometer, and GPS for geolocation.

[0072] Digital signal processing instructions, floating-point units (FPUs), single-cycle multiplication and accumulation, hardware partitioning for energy-efficient processing of computationally intensive operations.

[0073] Firmware that enables hardware to perform its intended functions. Based on a low-power profile, the firmware incorporates all operational methods aimed at efficient energy costs. All access is optimized for energy conservation. The hardware's non-volatile memory contains all the information necessary for automatically pairing the device.

[0074] In one embodiment, the firmware filters these digital signals, and this filtering utilizes a tool protocol based on events. The firmware includes a change detector for the most relevant information in the digital signals. Through the change detector, the firmware filters the signals based on the most relevant information changes.

[0075] In another embodiment, the firmware filters these digital signals, and this filtering utilizes a tool dynamic protocol. The firmware includes a classification device that sorts the digital signals into the most relevant and least relevant information.

[0076] In another embodiment, the firmware filters these digital signals, and this filtering utilizes the combination of protocols described above. In yet another embodiment, the processor converts the digital signals into digital signals of volume change, which are measurements in the micrometer range.

[0077] The system is powered by the long battery life of the lithium-ion battery, consisting of an internal battery (9) and an external battery (15). The external battery (15) is the first power source of the system and charges the internal battery (9). When the external battery is being charged via USB with a charge gauge, the internal battery (9) serves as the second power source of the system. The system further comprises the following:

[0078] The system further includes, for data transmission, a wireless connection via a wireless antenna (13), Bluetooth® 5.0, an on-chip short-range wireless communication tag, a pre-configured receiver, secure authentication pairing between two pre-configured devices, a central processing unit, high throughput, advertising extension, Bluetooth Low Energy (BLE), and a U.FL connector for an external omnidirectional antenna.

[0079] In one embodiment, the system has high priority in the steps of receiving, processing, and transmitting signals to a pre-configured receiver connected to a central processing unit. Real-time, fluid data transmission is achieved by utilizing data encryption to prevent interception of the collected signals without losing relevant data.

[0080] Firmware updates are performed wirelessly via an app. The system is initially configured with a bootloader, which allows for firmware maintenance and repair.

[0081] The pre-configured receiver is responsible for reconstructing the analog signals related to intracranial pressure collected via the pre-configured receiver and distributing those signals to a monitor, app, or central processing unit.

[0082] In one embodiment, the system includes a database with rules, functions, and the aforementioned methods implemented to facilitate access to the reading and input of new configurations of the tools. Tools such as AD converters via serial peripheral interface communication have various configurations of filters, sample rates, auto-gain, and auto-offset. These tools can be accessed via read mode and processed via write mode, thus enabling remote dynamic configuration.

[0083] For further explanation of the embodiments, the device is shown in Figure 5. In one embodiment, the housing includes an upper protective section (1) connected to a lower base (3) to enclose and protect the components, the lower base connecting to the user's skin when the device is in use.

[0084] In this embodiment, the processor, which includes tools for processing signals, is the circuit board of the main sensor (2) and communicates with the variable transducer (8). One of the auxiliary screws (10) functions as a change detector for the device. The variable transducer (8) is cantilevered to the base (4). The base includes the circuit board of at least one compensation sensor located on the base (4) and functions as a compensation unit connected to the housing via the auxiliary screw (10), and communicates with the circuit board of the main sensor (2) to receive analog signals from the compensation sensors and to process intracranial pressure more accurately, or to transmit analog signals received from at least one compensation sensor.

[0085] In one embodiment, the locking device is provided with a first end containing a trigger (7.1) and a second end opposite the first end containing an opening (7.2), the opening (7.2) being configured to be associated with a change detector. In one embodiment, the opening (7.2) is connected to a pin, the pin having a gap for connecting the opening (7.2) between two raised peaks around it to prevent movement perpendicular to the connection between the opening (7.2) and the pin. In one embodiment, the opening (7.2) is connected to a pin, the pin having a gap for connecting the opening (7.2) above a raised peak to prevent movement of the pin that could deform a change transducer (8). In one embodiment, the opening (7.2) is connected to a pin, the pin and the opening have a circular circumference, the pin having a larger diameter than the opening (7.2), and when connected, friction prevents movement perpendicular to the connection between the opening (7.2) and the pin.

[0086] In one embodiment, the range-defining enclosure (6) is located opposite the first end of the change detector, and the range-defining enclosure (6) includes a restricting element (6.1). In a further embodiment, the housing includes a safety space between the range-defining enclosure (6) and the change transducer (8), the safety space enabling safe deformation of the change transducer (8).

[0087] In one embodiment, the switch (5) includes a trigger opening (5.1) configured to be associated with a trigger (7.1), the trigger (7.1) being located inside the trigger opening (5.1), and the displacement of the switch (5) being restricted by a restricting element (6.1).

[0088] The internal battery (9) is located inside the housing. Screws (11) secure the system and ensure all components are securely connected. A support component (12) is located on top of the circuit board of at least one correction sensor, which is positioned on the base (4). A wireless antenna (13) acts as the system's transmitter, is located inside the housing, communicates with the circuit board of the main sensor (2), and transmits the processed signal to a pre-configured receiver.

[0089] The external protection unit (14) covers the upper protection unit (1) to protect the external battery (15) connected to the upper protection unit (1) together with the upper protection unit (1). A spring (16) connected to the linked enclosure (19) works in conjunction with the bond enclosure (17) to lock and unlock the external battery (15) to the housing. A battery connector (18) fixed to the circuit board of the main sensor (2) enables communication between the circuit board of the main sensor (2) and the external battery (9). The lower protection unit (20), positioned between the circuit board of the main sensor (2) and the upper protection unit (1), protects the circuit board of the main sensor (2) from direct impact.

[0090] In another exemplary embodiment, the method is performed as shown in Figure 1, where a change in the user's cranial volume causes a deflection in the pins of the sensing device. The pins transmit this deflection, thereby deforming a change transducer and generating a differential voltage signal related to the user's intracranial pressure.

[0091] This signal is analog and is received by a receiver, which then sends it to a processor to convert the analog signal to a digital signal. In this example, the processor uses an ADC tool for this conversion. The digital signal is modulated to produce a processed signal that can be transmitted by the transmitter. The transmitter then wirelessly transmits the processed signal to a pre-configured receiver.

[0092] In another exemplary embodiment, the method is performed as shown in Figure 2, where a change in the user's cranial volume causes a deflection in the pins of the sensing device. The pins transmit this deflection, thereby deforming a change transducer and generating a differential voltage signal related to the user's intracranial pressure.

[0093] This signal is analog and is received by a receiver, which then converts the analog signal to a digital signal and sends it to a processor for amplification. In this example, the processor uses an ADC tool for this conversion. Next, the processor runs another tool to convert the digital signal into a digital signal of volume changes in the micrometer range. The digital signal of volume changes is modulated for transmission by a transmitter. The transmitter then wirelessly transmits the digital signal of volume changes to a pre-configured receiver.

[0094] In another exemplary embodiment, this method is performed as shown in Figure 3. A change in the user's cranial volume causes a deflection in the pins of the sensing device. The pins transmit this deflection, thereby deforming a change transducer and generating a differential voltage signal related to the user's intracranial pressure.

[0095] In parallel with the detection of changes in cranial volume, multiple environmental and inertial sensors detect pressure, humidity, temperature, acceleration, geolocation information, and magnetism, and transmit these signals to the processor.

[0096] The differential voltage signal is analog and is received by the receiver, which then converts the analog signal to a digital signal and sends it to the processor for amplification. The processor further processes the digital signal using a conversion tool to convert it into a digital signal of volume change in the micrometer range. Next, the processor's compensation unit tool processes the digital signal of volume change and signals detected by multiple environmental and inertial sensors to generate a compensation signal, thereby eliminating noise from user movement and other loss of compensation in user monitoring. For example, if the user moves to a covered area in the sun, the signal processing detects the temperature change and controls any physical changes that this temperature change may cause. The compensation signal is modulated for transmission by the transmitter. The transmitter then wirelessly transmits the compensation signal to a pre-configured receiver.

[0097] Those skilled in the art can evaluate the knowledge herein and reproduce the present invention in the provided methods and other modifications included within the appended claims.

Claims

1. A device for measuring changes in cranial volume, a. A change transducer comprising a change detector having one end on the cranial side and the other end on the opposite side thereof, wherein the change transducer is configured to receive deflection related to changes in cranial volume and converts the detected change into an electrical signal, b. A housing comprising a locking device having a first end including a trigger and a second end opposite the first end including an opening, wherein the opening is configured to be connected to the change detector, and the housing further comprises a range-defining enclosure located at the other end of the change detector, the range-defining enclosure comprising a restricting element, A device equipped with the following features.

2. The device according to claim 1, wherein the change detector includes a pin provided at one end, the pin is connected to the change transducer, the pin detects a change and causes deformation in the change transducer for conversion into an electrical signal, and the pin is connected to the opening of the locking device, and is configured such that movement in a direction perpendicular to the connection portion with the opening is prevented by friction.

3. The device according to claim 1, wherein the enclosure includes a safety space between the range-defining enclosure and the variable transducer, and the safety space enables the safe deformation of the variable transducer.

4. The device according to claim 1, wherein the housing comprises a switch having a trigger opening configured to be associated with the trigger, the trigger being located within the trigger opening, and the restricting element restricting the displacement of the switch so that the amount of displacement of the switch falls within a predetermined range.

5. The device according to claim 4, wherein the variable transducer is fixed to the base in a cantilevered manner.

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