Wireless implantable intracranial probe system integrated with multi-parameter monitoring

Abstract

The invention relates to the technical field of neurosurgery medical monitoring equipment, and discloses an integrated multi-parameter monitoring wireless implantable intracranial probe system which comprises a probe interface box, and a probe signal acquisition board, a main control module and a non-invasive blood oxygen detection module are arranged in the probe interface box. The probe signal acquisition board is electrically connected with the probe through a data transmission cable, the main control module is in wireless communication connection with the display terminal, and the probe is integrated with a piezoresistive intracranial pressure sensor, a thermistor temperature sensor, an electrochemical brain oxygen sensor and a graphene-polydopamine composite electrode array. According to the application, direct connection of a lead to monitoring equipment is completely avoided, limitation of doctor nursing operation or patient action caused by cable pulling is fundamentally eliminated, meanwhile, a patient gets rid of constraint of the lead, the head and the body can freely move, nursing and rehabilitation training are facilitated, and patient experience is remarkably improved. The intracranial pressure, intracranial temperature, brain tissue oxygen partial pressure, local brain tissue blood oxygen saturation and rebleeding monitoring can be achieved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of neurosurgical and neurological monitoring devices, in particular to a wireless implantable intracranial probe system integrated with multi-parameter monitoring. BACKGROUND

[0002] Elevated intracranial pressure is a serious complication of various brain diseases (such as traumatic brain injury, cerebral hemorrhage, brain tumor, hydrocephalus, etc.), which can lead to brain herniation and even death. Continuous and accurate monitoring of intracranial pressure and temperature is crucial for guiding clinical treatment and evaluating prognosis. Postoperative rebleeding is a serious and rapid threat to patient safety. Rebleeding can cause a sharp rise in intracranial pressure and induce fatal brain herniation, causing devastating neurological damage, which is one of the key factors leading to postoperative patient death. Even if the patient ultimately survives, it will still cause a series of serious sequelae, usually permanent disability (such as paralysis, aphasia, dementia, and vegetative state), and greatly increase the difficulty and cost of treatment. The occurrence of intracranial rebleeding during surgery and postoperatively seriously affects the prognosis of patients and the judgment of the patient's condition by doctors.

[0003] The current standard implantable intracranial pressure monitoring probe (such as optical fiber probe, piezoelectric probe) usually needs to be connected to the external monitor through the lead wire passing through the scalp and skull. This wired connection method has significant drawbacks: due to the long cable connection, the fragile probe is easily pulled and damaged, which severely limits the surgical implementation during the operation; secondly, the patient's activity is limited, and the lead wire restricts the patient's head movement, increasing the difficulty of nursing and the patient's discomfort; accidental falling risk, the lead wire may be accidentally pulled, causing the probe to shift or fall, which may cause additional risks when moving. The current intracranial pressure probe only has a single intracranial pressure parameter, which is not sufficient to fully reflect the physiological state of the brain. Monitoring of cerebral tissue oxygenation (blood oxygen saturation) and postoperative rebleeding are two key indicators, especially in brain injury, cerebral hemorrhage, and cerebral ischemic diseases. Simultaneous monitoring of intracranial pressure and cerebral tissue oxygenation and rebleeding has important value for evaluating cerebral autoregulation function and guiding individualized treatment.

[0004] Wireless data transmission technology is increasingly widely used in medical devices, which can effectively solve many problems caused by wired connection, but there is currently no mature, reliable, and integrated intracranial wireless probe system for monitoring intracranial pressure, temperature, non-invasive local brain tissue oxygen saturation, and postoperative intracranial rebleeding. SUMMARY

[0005] In view of the above technical problems in the related art, the present application provides a wireless implantable intracranial probe system integrated with multi-parameter monitoring, which can solve the above problems.

[0006] To achieve the above technical purposes, the technical scheme of the present application is as follows: A wireless implantable intracranial probe system integrated with multi-parameter monitoring, comprising a probe interface box, a probe signal acquisition board, a main control module and a non-invasive blood oxygen detection module are arranged in the box of the probe interface box, the probe signal acquisition board is electrically connected with the probe through a data transmission cable, the main control module is wirelessly connected with a display terminal, and the probe is integrated with a piezoresistive intracranial pressure sensor, a thermistor temperature sensor, an electrochemical brain oxygen sensor and a graphene-polydopamine composite electrode array.

[0007] Further, the probe signal acquisition board comprises an analog front-end circuit, an analog-to-digital converter, a temperature compensation unit, a rebleeding low-frequency excitation circuit and a receiving circuit, the non-invasive blood oxygen detection module, the piezoresistive intracranial pressure sensor, the thermistor temperature sensor, the electrochemical brain oxygen sensor and the graphene-polydopamine composite electrode array are all electrically connected with the probe signal acquisition board through the data transmission cable.

[0008] Further, the probe signal acquisition board is electrically connected with the main control module, the main control module is integrated with a wireless Bluetooth transmission unit, and the main control module is wirelessly connected with the display terminal through the wireless Bluetooth transmission unit.

[0009] Further, one end of the side of the probe is provided with the piezoresistive intracranial pressure sensor, the probe is internally provided with the thermistor temperature sensor, and the front end of the probe is provided with the electrochemical brain oxygen sensor and the graphene-polydopamine composite electrode array.

[0010] Further, the graphene-polydopamine composite electrode array is deposited on a PDMS substrate with a thickness of 50 μm to form a micro-sensing unit with a diameter of 0.4 mm, and the graphene-polydopamine composite electrode array comprises a transmitting electrode and a receiving electrode.

[0011] Further, the probe is further provided with a bionic capillary structure for tissue passive sampling and transmission, and the detection part of the electrochemical brain oxygen sensor and the graphene-polydopamine composite electrode array is communicated with the bionic capillary structure.

[0012] Further, the probe has a diameter of 1.0 mm, a length of 4.5 mm and a weight of <0.9 g, is packaged with biocompatible polymer, and the surface is modified with an antibacterial nano-silver coating.

[0013] Further, the box of the probe interface box is further provided with a power module, the power module comprises a power supply and a power management chip, the outside of the box of the probe interface box is provided with a fitting structure for fitting the forehead of a patient, the fitting structure is made of medical soft silicone material, and an optical window opposite to the detection part of the non-invasive blood oxygen detection module is formed on the box body of the probe interface box.

[0014] The beneficial effects of this invention are as follows: This application completely avoids direct connection of wires to monitoring equipment, fundamentally eliminating the restrictions on doctor's nursing operations or patient's movement caused by cable pulling. Simultaneously, patients are freed from the constraints of wires, allowing for free movement of the head and body, facilitating nursing care and rehabilitation training, and significantly improving the patient experience. This application can achieve monitoring of intracranial pressure, intracranial temperature, brain tissue oxygen partial pressure, local brain tissue blood oxygen saturation, and rebleeding, making intracranial monitoring more comprehensive. Attached Figure Description

[0015] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0016] The present invention will now be described in further detail with reference to the accompanying drawings.

[0017] Figure 1 This is an architecture diagram of a wireless implantable intracranial probe system integrating multi-parameter monitoring, as described in an embodiment of the present invention. Figure 2 This is a schematic diagram of the probe interface box according to an embodiment of the present invention; Figure 3 This is a schematic diagram of the probe structure according to an embodiment of the present invention; Figure 4 This is an application scenario diagram of a wireless implantable intracranial probe system integrating multi-parameter monitoring, as described in an embodiment of the present invention.

[0018] In the picture: 1. Probe signal acquisition board; 2. Main control module; 3. Non-invasive blood oxygen detection module; 4. Data transmission cable; 5. Probe; 6. Piezoresistive intracranial pressure sensor; 7. Thermistor temperature sensor; 8. Graphene-polydopamine composite electrode array; 9. Probe interface box. Detailed Implementation

[0019] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention are within the scope of protection of the present invention.

[0020] like Figures 1-4As shown, the present invention discloses a wireless implantable intracranial probe system integrating multi-parameter monitoring, including a probe interface box 9. The probe interface box 9 is provided with a probe signal acquisition board 1, a main control module 2 and a non-invasive blood oxygen detection module 3. The probe signal acquisition board 1 is electrically connected to the probe 5 through a data transmission cable 4. The main control module 2 is wirelessly connected to a display terminal. The probe 5 integrates a piezoresistive intracranial pressure sensor 6, a thermistor temperature sensor 7, an electrochemical brain oxygen sensor and a graphene-polydopamine composite electrode array 8.

[0021] In one specific embodiment of this application, the probe signal acquisition board 1 includes an analog front-end circuit, an analog-to-digital converter (ADC), a temperature compensation unit, a rebleeding low-frequency excitation circuit, and a receiving circuit. The analog front-end circuit amplifies and filters the weak intracranial pressure, intracranial temperature, brain oxygenation, and blood oxygenation signals transmitted from the probe, as well as the circuit signals from the rebleeding low-frequency excitation circuit and the receiving circuit. The ADC converts the amplified and filtered analog signals into digital signals. The temperature compensation module uses the reading of the thermistor temperature sensor 7 to perform real-time temperature drift compensation on the output of the intracranial pressure sensor, improving the accuracy of ICP measurement. The rebleeding low-frequency excitation circuit and the receiving circuit use a microarray electrode to emit low-frequency pulse signals at one end and receive them at the other, analyzing the received low-frequency pulse signals to detect whether fresh rebleeding has occurred in the patient's intracranial cavity.

[0022] In one specific embodiment of this application, the main control module 2 integrates a wireless Bluetooth transmission unit. This unit modulates and encrypts (optionally) the processed digital signals (including ICP, temperature, blood oxygen data, brain tissue oxygen partial pressure, and detection results of whether rebleeding has occurred) and transmits them via a wireless channel. Preferably, the proprietary low-power, short-range Bluetooth (BLE) wireless communication protocol is used.

[0023] In one specific embodiment of this application, a piezoresistive intracranial pressure sensor 6 (accuracy ±0.5 mmHg) is provided at one end of the side of the probe 5 for monitoring intracranial pressure. A thermistor temperature sensor 7 is provided inside the probe 5 for monitoring intracranial temperature. An electrochemical brain oxygen sensor is provided at the front end of the probe 5 for monitoring the partial pressure of oxygen in intracranial brain tissue. A graphene-polydopamine composite electrode array 8 is also provided at the front end of the probe 5. The graphene-polydopamine composite electrode array 8 is patterned on a 50 μm thick PDMS substrate, forming a miniature sensing unit with a diameter of 0.4 mm. The graphene-polydopamine composite electrode array 8 includes a transmitting electrode (transmitting a signal) and a receiving electrode (receiving a signal), enabling online monitoring of microbleeds. This application designs a biomimetic capillary structure (15-30 μm in diameter) on the probe 5, which enables passive sampling and transmission of brain tissue from the electrochemical brain oxygen sensor and the graphene-polydopamine composite electrode array 8 without the need for an external pump. The probe 5 has a diameter of 1.0 mm, a length of 4.5 mm, and a weight of <0.9 g. It is encapsulated with a biocompatible polymer and has an antibacterial nano-silver coating on its surface. It is required to undergo biocompatibility testing and antibacterial testing.

[0024] In one specific embodiment of this application, the LED (660nm red light and 890nm infrared light) and photodetector of the non-invasive pulse oximetry module 3 are integrated on the back of the main control module 2. An optical window is provided on the probe interface box 9, opposite to the detection part of the non-invasive pulse oximetry module 3. The optical window is sealed with a biocompatible material with good light transmittance. A fitting structure for fitting the patient's forehead is provided on the outside of the probe interface box 9. The fitting structure is made of medical soft silicone material and will not damage the patient. At the same time, an elastic strap can be connected to the body of the probe interface box 9, which can be used to bind the probe interface box 9 to the patient's head, allowing the patient to move freely.

[0025] In one specific embodiment of this application, the display terminal can be a dedicated monitor or a cloud server. After receiving data, the display terminal decodes, stores, displays (real-time waveforms and values), analyzes (such as trend charts and alarm calculations), and / or remotely transmits (to a medical workstation or the cloud). Alarm thresholds for various parameters can be set.

[0026] In summary, this application has the following characteristics: Wireless operation significantly reduces the risk of infection: It completely avoids direct wire connection to monitoring equipment, fundamentally eliminating the restrictions on doctor care operations or patient movement caused by cable pulling.

[0027] Achieving multi-parameter integration: Intracranial pressure (ICP), intracranial temperature (Temp), and local brain tissue oxygen saturation were simultaneously measured within a single miniature probe. Monitoring of brain tissue oxygen partial pressure (PbtO2) provides more comprehensive brain physiological information.

[0028] Integrated rebleeding monitoring: A patterned graphene-polydopamine composite electrode array is deposited on a PDMS substrate with a thickness of only 50μm to form a miniature sensing unit with a diameter of 0.4mm. Low-frequency pulse signals are emitted from one end of the electrode and received and analyzed at the other end to monitor whether intracranial rebleeding has occurred in real time, thereby monitoring the patient's postoperative condition, reminding doctors of appropriate treatment measures, and improving postoperative prognosis.

[0029] Improved patient comfort and freedom of movement: Patients are freed from the constraints of wires, allowing them to move their head and body freely, facilitating care and rehabilitation training, and significantly improving the patient experience.

[0030] Remote monitoring capability: Data can be uploaded to the network via external terminals to enable remote monitoring, which is particularly suitable for patients who require long-term monitoring or transfer.

[0031] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A wireless implantable intracranial probe system integrating multi-parameter monitoring, characterized in that, The device includes a probe interface box (9), which contains a probe signal acquisition board (1), a main control module (2) and a non-invasive blood oxygen detection module (3). The probe signal acquisition board (1) is electrically connected to the probe (5) via a data transmission cable (4). The main control module (2) is wirelessly connected to a display terminal. The probe (5) integrates a piezoresistive intracranial pressure sensor (6), a thermistor temperature sensor (7), an electrochemical brain oxygen sensor and a graphene-polydopamine composite electrode array (8).

2. The wireless implantable intracranial probe system integrating multi-parameter monitoring according to claim 1, characterized in that, The probe signal acquisition board (1) includes an analog front-end circuit, an analog-to-digital converter, a temperature compensation unit, a rebleeding low-frequency excitation circuit, and a receiving circuit. The non-invasive blood oxygen detection module (3), the piezoresistive intracranial pressure sensor (6), the thermistor temperature sensor (7), the electrochemical brain oxygen sensor, and the graphene-polydopamine composite electrode array (8) are all electrically connected to the probe signal acquisition board (1) through the data transmission cable (4).

3. The wireless implantable intracranial probe system integrating multi-parameter monitoring according to claim 1, characterized in that, The probe signal acquisition board (1) is electrically connected to the main control module (2). The main control module (2) integrates a wireless Bluetooth transmission unit. The main control module (2) is wirelessly connected to the display terminal through the wireless Bluetooth transmission unit.

4. The wireless implantable intracranial probe system integrating multi-parameter monitoring according to claim 1, characterized in that, The probe (5) has a piezoresistive intracranial pressure sensor (6) on one side, a thermistor temperature sensor (7) inside the probe (5), and an electrochemical brain oxygen sensor and a graphene-polydopamine composite electrode array (8) at the front end of the probe (5).

5. The wireless implantable intracranial probe system integrating multi-parameter monitoring according to claim 1, characterized in that, The graphene-polydopamine composite electrode array (8) is deposited on a PDMS substrate with a thickness of 50 μm to form a micro sensing unit with a diameter of 0.4 mm. The graphene-polydopamine composite electrode array (8) includes an emitting electrode and a receiving electrode.

6. The wireless implantable intracranial probe system integrating multi-parameter monitoring according to claim 5, characterized in that, The probe (5) is also provided with a biomimetic capillary structure for passive tissue sampling and transmission. The detection part of the electrochemical brain oxygen sensor and the graphene-polydopamine composite electrode array (8) is connected to the biomimetic capillary structure.

7. The wireless implantable intracranial probe system integrating multi-parameter monitoring according to claim 1, characterized in that, The probe (5) has a diameter of 1.0 mm, a length of 4.5 mm, and a weight of <0.9 g. It is encapsulated with a biocompatible polymer and has an antibacterial nano-silver coating on its surface.

8. The wireless implantable intracranial probe system integrating multi-parameter monitoring according to claim 1, characterized in that, The probe interface box (9) is also equipped with a power module inside the box. The power module includes a power supply and a power management chip. The probe interface box (9) is equipped with a fitting structure for fitting the patient's forehead outside the box. The fitting structure is made of medical soft silicone material. The probe interface box (9) is equipped with an optical window on the box body that is opposite to the detection part of the non-invasive blood oxygen detection module (3).

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