US-20260123847-A1 - FLEXIBLE HYBRID ELECTRONIC SYSTEM FOR INTRAOPERATIVE INTRACRANIAL MONITORING

US20260123847A1US 20260123847 A1US20260123847 A1US 20260123847A1US-20260123847-A1

Abstract

Disclosed is a flexible hybrid electronic system for intraoperative intracranial monitoring. The system includes a flexible front-end signal collection circuit, a back-end signal processing circuit and a computer system, wherein the front-end signal collection circuit includes a flexible substrate, an electroencephalogram layer, a flexible sensor array, a temperature-controlled hydrogel interface layer, and an electrothermal film. The flexible sensor array is used for collecting pressure, temperature, electroencephalographic and cerebral tissue oxygen saturation signals, and the electrothermal film regulating the adhesion and peeling of the temperature-controlled hydrogel interface layer and cerebral tissue. The signal processing circuit is electrically connected to the signal collection circuit, so as to receive signals collected by the flexible sensor array and the electroencephalographic layer, analyze then transmit to the computer system. When the pressure data exceed a preset normal threshold, the alarm module is triggered to alert the surgeon to the cranial status.

Inventors

Hao Wu
Bo PANG
Ganguang Yang
Tao He

Assignees

HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY

Dates

Publication Date: 20260507
Application Date: 20260101
Priority Date: 20231231

Claims (10)

1 . A flexible hybrid electronic system for intraoperative intracranial monitoring, comprising a flexible front-end signal collection circuit, a back-end signal processing circuit, and a host computer system; wherein the flexible front-end signal collection circuit comprises a flexible framework body formed by a top encapsulation layer, an intermediate encapsulation layer, and a bottom substrate layer arranged from top to bottom, an electroencephalographic layer arranged between the intermediate encapsulation layer and the top encapsulation layer, a flexible sensor array disposed on an upper surface of the bottom substrate layer, a temperature-controlled hydrogel interface layer integrated above the top encapsulation layer, and an electrothermal film integrated below the bottom substrate layer, the electroencephalographic layer comprises a top substrate layer and an electroencephalographic electrode array and an internal circuit disposed on the top substrate layer, the electroencephalographic electrode array passes through the flexible framework body and connects with the temperature-controlled hydrogel interface layer, the flexible sensor array connects with the electroencephalographic layer through the intermediate encapsulation layer, the flexible sensor array is provided to detect a pressure signal, a temperature signal, and a cerebral tissue oxygen saturation signal, the electrothermal film controls adhesion of the temperature-controlled hydrogel interface layer through temperature, achieving adhesion and peeling of the temperature-controlled hydrogel interface layer with a cerebral tissue; the back-end signal processing circuit is electrically connected with the flexible front-end signal collection circuit to receive the pressure signal, the temperature signal, an electroencephalographic signal, and the cerebral tissue oxygen saturation signal, analyse and process the signals, and then transmit the signals to the host computer system through wireless or wired transmission method.
2 . The flexible hybrid electronic system for intraoperative intracranial monitoring according to claim 1 , wherein the flexible sensor array comprises a pressure sensor array, a temperature sensor array, and a cerebral tissue oxygen sensor, which are respectively electrically connected with the back-end signal processing circuit.
3 . The flexible hybrid electronic system for intraoperative intracranial monitoring according to claim 2 , wherein a plurality of pressure sensors in the pressure sensor array are all flexible pressure sensors.
4 . The flexible hybrid electronic system for intraoperative intracranial monitoring according to claim 2 , wherein the back-end signal processing circuit comprises a collection circuit, a core processing circuit, a multiplexer switch, a flexible battery, a power management chip, and a wireless transmitter, the flexible battery achieves power supply to the wireless flexible hybrid electronic system through the power management chip, the flexible sensor array and the electroencephalographic electrode array are respectively electrically connected with the collection circuit, the collection circuit is connected to the core processing circuit through the multiplexer switch, the collection circuit is configured to receive the pressure signal, the temperature signal, the electroencephalographic signal, and the cerebral tissue oxygen saturation signal and transmit the signals to the core processing circuit through the multiplexer switch, the core processing circuit is configured to process the signals transmitted by the collection circuit and send the signals to the host computer system.
5 . The flexible hybrid electronic system for intraoperative intracranial monitoring according to claim 4 , wherein the collection circuit comprises an operational amplifier, an electroencephalogram collection front-end, and a cerebral oxygen collection front-end, the operational amplifier is electrically connected with the pressure sensor array and the temperature sensor array, the electroencephalogram collection front-end is electrically connected with the electroencephalographic electrode array, the cerebral oxygen collection front-end is electrically connected with the cerebral tissue oxygen sensor.
6 . The flexible hybrid electronic system for intraoperative intracranial monitoring according to claim 4 , wherein the core processing circuit transmits the processed signals to the host computer system through the wireless transmission module or through a serial port.
7 . The flexible hybrid electronic system for intraoperative intracranial monitoring according to claim 1 , wherein materials of the top encapsulation layer, the intermediate encapsulation layer, the bottom substrate layer, and the top substrate layer in the flexible front-end signal collection circuit are all polydimethylsiloxane, the electroencephalographic electrode array, the internal circuit, and wires connecting various components of the wireless flexible hybrid electronic system are all prepared from flexible composite conductive materials.
8 . The flexible hybrid electronic system for intraoperative intracranial monitoring according to claim 1 , wherein the temperature-controlled hydrogel interface layer comprises a plurality of temperature-controlled hydrogel patches corresponding to electroencephalographic electrodes one by one in the electroencephalographic electrode array, the plurality of temperature-controlled hydrogel patches respectively cover the corresponding electroencephalographic electrodes, the temperature-controlled hydrogel patches are formed through photo-initiated polymerization using poly(ethylene glycol) diacrylate as an initiator and poly(3,4-ethylenedioxythiophene) and poly(styrene acid) as blending components.
9 . The flexible hybrid electronic system for intraoperative intracranial monitoring according to claim 8 , wherein a thermally-induced actuator is disposed in the electrothermal film, heating sites of the thermally-induced actuator correspond to positions of the temperature-controlled hydrogel patches one by one.
10 . The flexible hybrid electronic system for intraoperative intracranial monitoring according to claim 1 , wherein the host computer system is provided with an alarm module, when pressure data received in the host computer system is higher than a preset normal pressure, the alarm module activates an alarm.

Description

CROSS-REFERENCE TO RELATED APPLICATION The present application is a continuation of international PCT application serial No. PCT/CN2025/078874 filed on Feb. 24, 2025, which claims the priority benefit of China application No. 202311868676.8 filed on Dec. 31, 2023. The entirety of the above-mentioned patent application is incorporated herein by reference and made a part of this specification. TECHNICAL FIELD The present disclosure relates to the biomedical devices, and specifically relates to a flexible hybrid electronic system for intraoperative intracranial monitoring. DESCRIPTION OF RELATED ART The human brain, as the advanced central nervous system of the human body, is one of the most critical organs, characterized by its exceedingly complex structure and including a plurality of functional areas. According to data from the International Agency for Research on Cancer, there were 308,102 new cases of central nervous system brain cancer reported in 2020, with 25,139 deaths attributed to brain tumors. The incidence and mortality rates of brain tumors in China rank among the highest globally. Additionally, the mortality rate for patients with severe cranial trauma exceeds 20%, with a severe disability rate of more than 50%. Neurosurgical craniotomy is a crucial method for treating brain tumors and cranial trauma, serving as a necessary intervention when conventional treatments prove ineffective. Given the intricate structure of the cranial brain, which includes numerous central nerves, arterial and venous blood vessels, and functional areas responsible for language and movement, as well as the inherently fragile nature of a cerebral tissue, craniotomy is regarded as one of the most challenging and complex surgical procedures in clinical practice. Craniotomy primarily involves professional physicians and medical instruments to open the patient's cranial bone, followed by the excision of pathological tissues within the cranial cavity, thereby achieving therapeutic objectives. Craniotomy may be classified into bone window craniotomy and bone flap craniotomy, and it is utilized for treating diseases related to the cranium and brain. Craniotomy is a common neurosurgical procedure. The success rate of craniotomy varies depending on the specific disease being treated. Data indicate that the success rate of craniotomy for the removal of brain tumors is approximately 90%, while the success rate for craniotomy addressing cerebrovascular diseases generally ranges from 90% to 95%. However, the success rate may be lower for craniotomy performed on functional system diseases. One of the most common reasons for failure during the intracranial surgical phase is brain contusion and hemorrhage caused by the traction of the cerebral tissue. To provide the operator with sufficient visibility, it is necessary to retract the intracranial cerebral tissue during craniotomy. If the cerebral tissue is retracted improperly or for an inappropriate duration during the surgery, it could lead to cerebral tissue hemorrhage, resulting in brain contusion and hemorrhage. In severe cases, complications such as hypothalamic dysfunction may occur. Given the fragile nature of the cerebral tissue, utmost care should be taken to protect the cerebral tissue during craniotomy. Therefore, when necessary retraction is performed, cottonoid patties should be placed at the retraction site. The existing cottonoid patties are primarily composed of medical degreased patties or spunlace non-woven fabric. Serving as a thin and soft cushioning layer, these patties mitigate the pressure exerted by surgical instruments on the surrounding intracranial tissues during surgical procedures, thus safeguarding the neural tissues within the surgical area. This protection significantly reduces the risks of postoperative hemorrhage, cerebral contusions, and other complications. Direct contact between surgical instruments and cerebral tissues presents a substantial mechanical disparity between the conventional materials used in brain retractors and brain electrodes and the cerebral tissues themselves, which may easily lead to tissue damage. Improper handling during such operations considerably elevates the risk of postoperative complications and increases the likelihood of fatal or disabling outcomes. Due to the difficulty and complexity of neurosurgical craniotomy procedures, it is imperative for surgeons to constantly ensure during the operation that the surgical steps being undertaken do not cause damage to the patient's nerves, to ascertain whether the patient's vital signs are stable, and to ensure the accuracy of critical cerebral parameters to prevent postoperative complications. In addition to utilizing microscopic observation, intraoperative neurophysiological monitoring (IONM) may detect information imperceptible to the naked eye, thus reflecting various physiological indicators of the human body. Consequently, during surgery, it is essential to monitor and promp