A tackable, regulated hydrogel electrode clamp for intraoperative nerve potential monitoring

Abstract

The application provides a viscosity-controllable hydrogel electrode clamp for intraoperative nerve potential monitoring, which comprises a hand-held part, a fluid assembly, two clamp arms, two electrode probes and two probe sleeves; the fixed ends of the two clamp arms are fixedly connected with the hand-held part, and the clamping ends are oppositely arranged; the tail parts of the two electrode probes are connected with the clamping ends of the corresponding clamp arms; the two probe sleeves are respectively sleeved on the electrode probes; the probe sleeves are made of temperature-sensitive conductive hydrogel; the electrode probes sleeved with the probe sleeves are clamped on nerves and measure nerve potentials; and the fluid injection assembly is used for injecting fluids of different temperatures at the interface where the probe sleeves contact with the nerves to control the viscosity of the temperature-sensitive conductive hydrogel. In the process of clamping the nerves to perform intraoperative nerve potential monitoring, the electrode clamp is attached to the nerves with high fidelity to collect potential signals, and after the collection is completed, the electrode clamp can be separated from the nerves in a benign manner and the nerves can be protected from being damaged.

Description

Technical Field

[0001] This invention relates to the field of biomedical device technology, specifically to an adhesive, adjustable hydrogel electrode clip for intraoperative nerve potential monitoring. Background Technology

[0002] The nervous system, comprising the central and peripheral nervous systems, performs incredibly complex functions, transmitting nerve impulses and controlling overall bodily behavior. The brain contains hundreds of billions of neurons, connected by trillions of synapses to form a vast neural network, making it the most complex organ in the human body. This network is structurally highly complex and functionally extremely flexible, rapidly responding to environmental changes and adapting to diverse task requirements; its mechanisms and functions far exceed current human understanding. However, abnormal neuronal discharges lead to diseases of the central and peripheral nervous systems, such as Parkinson's disease, epilepsy, trigeminal neuralgia, and sciatica. Globally, hundreds of millions suffer from these neurological disorders, imposing trillions of dollars in economic burden on society annually. Neurosurgery is a crucial treatment for neurological diseases. It involves exposing the nerve and surrounding lesions to decompress the nerve and performing procedures like deep vein scintillation (DBS) implantation, thereby minimizing postoperative pain and controlling opioid abuse.

[0003] Currently, the success rate of neurosurgical treatment of nerve lesions relies primarily on specialists to assess the presence of abnormalities in the nervous system during surgery. However, this success rate is inconsistent across different diseases. For example, surgeries on deep brain functional areas are more complex, resulting in a lower success rate compared to surgeries on the cerebral cortex. Trigeminal neuralgia, for instance, is typically caused by abnormal electrical discharges due to compression of the nerve by blood vessels or other tissues. These discharges are transmitted to the sensory cortex, causing pain. The signals from these abnormal discharges are extremely subtle and difficult to detect because they occur within the brain tissue. Clinically, microvascular decompression is commonly used, with the primary goal of surgically removing or repositioning the blood vessels compressing the nerve to reduce pressure. However, surgeons rely solely on experience to assess the treatment's effectiveness during surgery. The re-emergence of abnormal nerve discharge signals is crucial for surgical success, but these signals are often unavailable during the procedure. Therefore, a comprehensive evaluation of the patient's prognosis after suturing is usually required to determine surgical success. This presents significant inconvenience for both surgeons and patients, potentially necessitating a second surgery.

[0004] During neurosurgery, exposing the lesion location allows for direct and precise localization of the nerve lesion, facilitating signal acquisition. Due to the high difficulty and complexity of these surgeries, flexible materials are typically used to cover the tissue surface to provide cushioning and protection against nerve damage. Besides visual observation of the patient's condition during surgery, intraoperative electrophysiology can detect nerve potentials. This is usually achieved by indirectly measuring evoked potential signals using a nerve probe, a method generally used to protect the nerve, provide timely feedback on physiological indicators, and ensure the smooth progress of the surgery. However, there are still no methods to monitor and differentiate abnormal discharge signals detected intraoperatively. This is because existing nerve probes use rigid materials, which are severely mismatched with the modulus of tissues and nerves. This heterogeneity and heterogeneity easily leads to damage. Therefore, the nerve electrophysiological probes cannot be fully clamped to the nerve root, cannot make complete contact with the nerve, and the measured signal artifacts are large, completely masked by noise, making it impossible to judge abnormal nerve signals. Thus, using existing nerve electrophysiological probes for intraoperative electrophysiological monitoring makes it difficult to determine the prognosis caused by problems in the patient's nervous system. In neurosurgery, identifying abnormal discharge signals and eliminating or reducing these abnormal discharges caused by nerve compression during surgery is crucial for surgical success. Therefore, there is an urgent need for a device that can fully contact the nerve safely and reliably without causing nerve damage to obtain stable potential signals.

[0005] For the identification of abnormal neural signals, electromyography (EMG) and evoked potential (EPP) instruments are currently commonly used. Signals from different locations can be categorized into nerve conduction velocity measurement, somatosensory evoked potentials (SEP), auditory evoked potentials (AEP), visual evoked potentials (VAP), motor evoked potentials (MAP), and electroencephalography (EEG). These testing methods cover various neural measurement scenarios. However, the host computer mostly sends raw signals for the doctor's interpretation and lacks automatic analysis capabilities. For intraoperative neural potentials, in order not to affect the operation, it is generally necessary to promptly assess the success of the surgery. This requires simultaneously clamping the nerve to obtain stable signals and promptly identifying abnormal neural potentials. Summary of the Invention

[0006] To address the problems existing in the background art, the present invention provides an adhesive adjustable hydrogel electrode clip for intraoperative nerve potential monitoring. Because the probe is nested with a probe sleeve made of temperature-sensitive conductive hydrogel, the electrode clip adheres to the nerve to collect high-fidelity potential signals during the intraoperative nerve potential monitoring process. After the acquisition is completed, it achieves benign separation from the nerve and protects the nerve from damage.

[0007] The technical solution of the present invention to solve the above-mentioned technical problems is as follows:

[0008] This invention provides an adhesive, adjustable hydrogel electrode clip for intraoperative nerve potential monitoring, comprising a handheld part, a fluid injection component, two clamping arms, two electrode probes, and two probe sleeves. Each clamping arm includes a fixed end and a clamping end. The fixed ends of the two clamping arms are fixedly connected to the handheld part, and the clamping ends are arranged opposite each other. The two electrode probes are arranged one-to-one with the two clamping arms, and the tail of each electrode probe is connected to the clamping end of its corresponding clamping arm. The two probe sleeves are arranged one-to-one with the two electrode probes and are fitted onto their corresponding electrode probes. The two electrode probes with probe sleeves are used to clamp the nerve during surgery and measure nerve potential. The probe sleeves are made of temperature-sensitive conductive hydrogel, which has temperature responsiveness and different viscosity and hydrophilicity at different phase transition temperatures. The fluid injection component is used to inject fluids of different temperatures at the interface between the probe sleeves and the nerve, thereby controlling the temperature of the probe sleeves and thus controlling their viscosity, achieving close adhesion and non-destructive separation from the nerve.

[0009] During surgery, a viscous, adjustable hydrogel electrode clip for intraoperative nerve potential monitoring is held at the nerve root. At this time, the ambient temperature is below the phase transition temperature of the thermosensitive conductive hydrogel. The thermosensitive conductive hydrogel has a hydrophilic surface and high viscosity, allowing it to contact and adhere to the nerve. A probe sleeve made of the thermosensitive conductive hydrogel transmits the nerve electrical signal into the electrode probe, completing the acquisition of intraoperative nerve potentials. After signal measurement, a fluid above the phase transition temperature is introduced through a fluid injection component. The fluid is dripped between the probe sleeve and the nerve interface, and the temperature of the thermosensitive conductive hydrogel is controlled. As the temperature rises, a phase transition occurs, resulting in hydrophobicity and reduced viscosity, allowing the electrode clip to detach from the nerve without adhesion. Since multiple nerves need continuous monitoring during the procedure, the electrode clip is then applied to the next nerve to be monitored. A fluid below the phase transition temperature is introduced, causing the temperature of the thermosensitive conductive hydrogel to decrease and its viscosity to increase, allowing it to adhere tightly to the nerve for nerve potential measurement and acquisition. After measurement, a fluid above the phase transition temperature is introduced to separate the hydrogel from the nerve. This process is repeated until the potential monitoring of all nerves is completed.

[0010] The beneficial effects of this invention are:

[0011] 1) The adhesive adjustable hydrogel electrode clip of the present invention for intraoperative nerve potential monitoring achieves nerve clamping for intraoperative nerve potential monitoring by covering the electrode probe with a probe sleeve made of temperature-sensitive conductive hydrogel. The hydrogel has the characteristics of low modulus and small volume. On the one hand, it can sensitively sense temperature changes and make corresponding shrinkage or expansion deformation responses according to temperature changes, and regulate its hydrophilicity, hydrophobicity and viscosity to achieve safe and non-destructive conformal coupling and benign separation between the hydrogel and the nerve. On the other hand, it plays a buffering and protective role in the process of clamping the nerve. The electrode clip can achieve high-fidelity anti-artifact nerve potential signal acquisition while effectively protecting the nerve in the exposed state during surgery.

[0012] 2) By using fluid introduction for temperature regulation, continuous and precise temperature control is ensured, and the operation is simple, ensuring the safety and effectiveness of the surgical procedure.

[0013] According to the above scheme, the fluid injection assembly includes two fluid pipes respectively arranged on the two clamping arms along the length direction, with open ends. The outlet ends are respectively located above the corresponding probe sleeves, and the inlet end can be connected to an external circulation pump for injecting fluids of different temperatures.

[0014] According to the above scheme, the probe sleeve is prepared by 3D printing mold, and the two probe sleeves are nested and covered on the corresponding electrode probes respectively.

[0015] According to the above scheme, the temperature-sensitive conductive hydrogel includes a hydrogel framework composed of amide monomers, zwitterionic monomers and chitosan-gallic acid, and conductive fillers dispersed in the hydrogel framework.

[0016] According to the above scheme, the amide monomer is one or more of N-vinylcaprolactam, acrylamide, or N-isopropylacrylamide; the zwitterionic monomer is 2-methacryloyloxyethylphosphorylcholine (MPC) or sulfobetaine methacrylate (SBMA); and the conductive filler is any one or more of PEDOT:PSS, polypyrrole, polyaniline, and their derivatives.

[0017] According to the above scheme, the temperature-sensitive conductive hydrogel also includes a crosslinking agent and an initiator for achieving chemical crosslinking of amide monomers.

[0018] According to the above scheme, the crosslinking agent is polyethylene glycol diacrylate (PEGDA).

[0019] According to the above scheme, the initiator is one or more of α-ketoglutaric acid, Irgacure2959, Irgacure1173, TPO and LAP.

[0020] According to the above scheme, in the thermosensitive conductive hydrogel, the mass fractions of the amide monomer, zwitterionic monomer, chitosan-gallic acid, conductive filler, initiator and crosslinking agent are 25 wt%-35 wt%, 5 wt%-15 wt%, 5 wt%-10 wt%, 2 wt%-8 wt%, 0.02 wt%-0.08 wt%, and 0.02 wt%-0.1 wt%, respectively.

[0021] Thermosensitive conductive hydrogels are formed by UV-initiated polymerization of amide monomers, zwitterionic monomers, chitosan-gallic acid, conductive fillers, initiators, and crosslinking agents. The initiator decomposes under UV irradiation to generate highly reactive free radicals, which initiate chain addition polymerization of the monomers. Simultaneously, the crosslinking agent crosslinks the polymer chains together, forming a three-dimensional crosslinked network. During this process, the thermosensitive polyamide polymers integrated into the crosslinked network through free radical reactions influence the hydrogel's temperature responsiveness, hydrophilicity, and viscosity. The zwitterionic monomers enhance the hydrophilicity and lubricity of the hydrogel and regulate its anti-swelling ability. Chitosan-gallic acid (CS-GA) further enhances the hydrogel's viscosity, and the conductive filler, uniformly dispersed within the hydrogel, imparts excellent conductivity.

[0022] The temperature responsiveness of the aforementioned thermosensitive conductive hydrogel is caused by a temperature-mediated hydrophilic-hydrophobic transition in the polymer chains.

[0023] Specifically, the thermosensitive amide polymer chain possesses both hydrophobic isopropyl groups and hydrophilic amide groups. When nerve potential testing is required during surgery, the ambient temperature is controlled below the phase transition temperature. At this time, the pyrogallol groups in the thermosensitive conductive hydrogel form Michael addition, Schiff base reactions, and hydrogen bonds with the nerve interface. The zwitterionic groups form electrostatic coupling effects with the carboxyl and amino groups at the nerve interface. The amide groups in the thermosensitive amide polymer chain form hydrogen bonds with solvent molecules, increasing the affinity between the polymer chain and the solvent, causing the polymer chain to extend. Accompanying the increase in the macroscopic volume of the gel, the thermosensitive conductive hydrogel exhibits hydrophilic properties, reduced impedance, and increased viscosity. It comes into contact with the nerve and adheres to it. The conductive filler transmits the signal to the electrode probe, thus completing the acquisition of nerve potential signals. After the signal measurement is completed, a fluid above the phase transition temperature is introduced into the fluid pipeline to raise the temperature of the thermosensitive conductive hydrogel. When the hydrogel temperature exceeds the phase transition temperature, the long chains of the polyamide polymer aggregate, the hydrogel undergoes a phase transition, resulting in an increase in the interfacial layer modulus, tighter chain entanglement, and disruption of hydrogen bonds. The amide groups in the thermosensitive amide polymer chains dehydrate, leading to enhanced hydrophobic interactions between the isopropyl side chains. The polymer chains form a tightly contracted state, and the probe sleeve made of the thermosensitive conductive hydrogel exhibits a hydrophobic state. The hydrogen bonds inside the hydrogel break, expelling water, reducing viscosity, and preventing adhesion to the nerve, allowing the electrode clip to be removed from the nerve measurement location.

[0024] The fluid used to regulate the temperature of the temperature-sensitive conductive hydrogel can be selected from buffer solution or physiological saline; specifically, the buffer solution can be PBS buffer. In one specific embodiment, the phase transition temperature of the temperature-sensitive conductive hydrogel is 37°C, the high-temperature fluid is 39°C, and the low-temperature fluid is 33°C.

[0025] In one specific embodiment, the above-mentioned thermosensitive conductive hydrogel is prepared by using N-isopropylacrylamide (NIPAM) as the amide monomer, 2-methacryloyloxyethylphosphorylcholine amphoteric monomer (MPC) as the zwitterionic monomer, PEDOT:PSS as the conductive filler, polyethylene glycol diacrylate (PEGDA) as the crosslinking agent, and α-ketoglutaric acid as the initiator. The preparation method of the thermosensitive conductive hydrogel is as follows:

[0026] S1: Dissolve 5-10 mmol of 2-morpholinoethanesulfonic acid (MES) and 5-10 mmol of NaCl in 100 ml of deionized water and adjust the pH to 5.5 to obtain MES buffer solution;

[0027] S2: Dissolve 2-4g of chitosan (CS) in the above MES solution with a pH of 5.5 and stir thoroughly until it is completely dissolved;

[0028] S3: Slowly dissolve 10-20 mmol of gallic acid (GA) in 20 ml of MES solution, add 5-10 ml of ethanol, add 10-20 mmol of 1-ethyl-(3-dimethylaminopropyl)carbodiimide hydrochloride and 10-20 mmol of N-hydroxythiosuccinimide, and stir magnetically for 0.5-1 h to activate the carboxyl group;

[0029] S4: Add the above gallic acid (GA) solution to the chitosan (CS) solution, mix thoroughly, degas, seal and stir thoroughly for 12 hours, dialyze for 48 hours and freeze dry to obtain chitosan-gallic acid (CS-GA) polymer chains;

[0030] S5: Dissolve 4g of N-isopropylacrylamide (NIPAM) monomer, 1g of 2-methacryloyloxyethylphosphorylcholine zwitterionic monomer (MPC), and 4 mmol-16 mmol of PEDOT:PSS in 10ml of deionized water. Stir magnetically until the solution is homogeneous. Then add 1g of chitosan-gallic acid (CS-GA) adhesive functional polymer chain and stir magnetically until homogeneous.

[0031] S6: Add 0.02-0.1 wt% polyethylene glycol diacrylate (PEGDA) and 0.02-0.08 wt% α-ketoglutaric acid to the above solution in sequence. After stirring magnetically until fully dissolved, degas for 10-15 min. Continue stirring in the dark to mix evenly and obtain a pregel solution.

[0032] S7: Pour the above pregel solution into a mold and place it under a UV lamp with a wavelength of 360 nm for UV curing for 15 min. Then demold to obtain a thermosensitive conductive hydrogel.

[0033] According to the above scheme, the head of the electrode probe is a small head, the tail is a large head, and the inner surface that contacts the nerve is an arc surface. Its head is semi-circular or spherical to avoid stress concentration and cause craniocerebral injury.

[0034] The distance between the tails of the two electrode probes, which are fitted with probe sleeves, is less than the diameter of the nerve, while the distance between the heads is greater than the diameter of the nerve.

[0035] According to the above scheme, the adhesive adjustable hydrogel electrode clip for intraoperative nerve potential monitoring also includes a back-end signal processing system and a host computer system. The back-end signal processing system is electrically connected to the electrode probe through a data connection line set in the clip arm to receive nerve potential signals, and after analyzing and processing them, transmits them to the host computer system through wireless or wired transmission.

[0036] According to the above scheme, the back-end signal processing system includes a potential acquisition front-end module, a core processing module, a flexible battery, a power management chip, a wireless transmission module and / or a standard wired interface. The flexible battery supplies power to the adhesively adjustable hydrogel electrode clip through the power management chip. The potential acquisition front-end module is connected to the electrode probe and the core processing module respectively, and is used to receive the neural potential signals acquired by the electrode probe and transmit them to the core processing module. The core processing module is used to process the signals transmitted by the potential acquisition front-end module and send them to the host computer system.

[0037] According to the above scheme, the host computer system includes a front-end display module and a back-end data processing and classification module. The front-end display module is used to view the current signal waveform and nerve potential status. The back-end data processing and classification module is used to process the nerve potential signal, distinguish between abnormal and normal nerve potential signals, score and map them with the patient's prognosis, realize the intraoperative judgment of nerve potential, and provide functions for adding, deleting, modifying, querying, storing and exporting patient information.

[0038] The electrode clip body consists of an electrode probe, probe sleeve, clamp arm, fluid pipe, handheld part, and data connection cable. Through the electrode clip body, back-end signal processing system, and host computer system, real-time monitoring of nerve potentials during surgery can be achieved. By evaluating and analyzing the data, it can assist in assessing the nerve status during surgery, providing certain assistance and support to the surgeon. It can also judge the success of the surgery from the perspective of nerve potentials, thereby improving the success rate of surgery, avoiding secondary surgery due to nerve abnormalities, and helping the patient's prognosis and recovery. Attached Figure Description

[0039] Figure 1 This is a schematic diagram of the adhesive-adjustable hydrogel electrode clip for intraoperative nerve potential monitoring according to Embodiment 1 of the present invention.

[0040] Figure 2 This is a schematic diagram of the adhesive-adjustable hydrogel electrode clip for intraoperative nerve potential monitoring according to Embodiment 2 of the present invention.

[0041] Figure 3 This is a schematic diagram of the interface of the temperature-sensitive conductive hydrogel in Embodiment 1 of the present invention;

[0042] Figure 4 This is a schematic diagram of the preparation process of the temperature-sensitive conductive hydrogel in Embodiment 1 of the present invention;

[0043] Figure 5 This is a schematic diagram illustrating the viscosity control principle of the temperature-sensitive conductive hydrogel in Embodiment 1 of the present invention.

[0044] Figure 6This is a schematic diagram illustrating the method of using the adhesive adjustable hydrogel electrode clip for intraoperative nerve potential monitoring according to Embodiment 2 of the present invention.

[0045] Figure 7 This is a schematic diagram of the rear end of the adhesive adjustable hydrogel electrode clip for intraoperative nerve potential monitoring according to Embodiment 2 of the present invention.

[0046] Figure 8 This is a schematic diagram of the adhesive, adjustable hydrogel electrode clip for nerve conduction measurement used in intraoperative nerve potential monitoring according to the present invention.

[0047] In all the accompanying drawings, the same reference numerals are used to denote the same elements or structures, wherein: 101 is a probe sleeve; 102 is an electrode probe; 103 is a clamping arm; 104 is a fluid conduit; 105 is a handheld part; 106 is a data connection cable; 107 is a back-end signal processing system; 108 is a host computer system; 201 is poly(N-isopropylacrylamide) PNIPAM; 202 is 2-methacryloyloxyethylphosphorylcholine (MPC). 203 is chitosan-gallic acid (CS-GA); 204 is poly(3,4-ethylenedioxythiophene)-polystyrene sulfonic acid PEDOT:PSS; 205 is hydrogen bond; 206 is polyethylene glycol diacrylate PEGDA; 301 is MES mixture; 302 is chitosan (CS) solution; 303 is gallic acid (GA) solution; 304 is original mixture; 305 is pre-gelling solution; 306 is UV lamp; 307 is 3D printing mold; 308 is temperature-sensitive conductive water. Gel; 501 is the hand; 502 is the nerve; 503 is the electrode clip body; 603 is the fluid; 605 is the potential acquisition front-end module; 606 is the core processing module; 607 is the clock crystal oscillator module; 608 is the power management chip; 609 is the program download module; 610 is the wireless transmission module; 611 is the serial port; 612 is the USB interface; 613 is the algorithm classification; 615 is the flexible battery; 801 is the electromyography evoked potential stimulator; 802 is the electrical stimulation current; 803 is the nerve acquisition point. Detailed Implementation

[0048] The principles and features of the present invention are described below with reference to the accompanying drawings and specific embodiments. The examples given are only for explaining the present invention and are not intended to limit the scope of the present invention.

[0049] Example 1

[0050] like Figure 1As shown, this embodiment provides an adhesively adjustable hydrogel electrode clip for intraoperative nerve potential monitoring, including a handle 105, a fluid injection assembly, two clamping arms 103, two electrode probes 102, and two probe sleeves 101. The handle 105 is for the surgeon to hold. Each clamping arm 103 includes a fixed end and a clamping end. The fixed ends of the two clamping arms 103 are fixedly connected to the handle 105, and the clamping ends are arranged opposite each other. The two electrode probes 102 are arranged one-to-one with the two clamping arms 103, and their tails are fixedly connected to the clamping ends of their corresponding clamping arms 103. The two probe sleeves 101 are arranged one-to-one with the two electrode probes 102, and are fitted onto their corresponding electrodes by an interference fit. The electrode probe 102 is physically connected to the clamping arm, which is integrally molded and electrically connected. It is used to clamp the nerve, measure nerve potential, and transmit potential signals. The two electrode probes 102, which are fitted with probe sleeves 101, are used to clamp the nerve during the operation and measure nerve potential. The probe sleeves 101 are made of temperature-sensitive conductive hydrogel. The temperature-sensitive conductive hydrogel has temperature responsiveness and different viscosity and hydrophilicity at different phase transition temperatures. The fluid injection component is used to inject fluids of different temperatures at the interface between the probe sleeves 101 and the nerve to regulate the temperature of the probe sleeves 101 and thus regulate its viscosity to achieve close contact and non-destructive separation with the nerve.

[0051] Since the temperature of cranial tissue is around 37°C, the phase transition temperature of the aforementioned temperature-sensitive conductive hydrogel is set to 36~38°C. Below the phase transition temperature, the probe sleeve 101 made of the temperature-sensitive conductive hydrogel exhibits hydrophilicity and high viscosity, and adheres tightly to the nerve. Above the phase transition temperature, the probe sleeve 101 made of the temperature-sensitive conductive hydrogel exhibits hydrophobicity and low viscosity, and detaches from the nerve.

[0052] The clamp arm 103 is equipped with a data connection cable 106, one end of which is connected to the electrode probe 102, and the other end passes through the handheld part 105.

[0053] During the surgery, a viscous, adjustable hydrogel electrode clip for intraoperative nerve potential monitoring is held at the nerve root. At this time, the ambient temperature is lower than the phase transition temperature of the thermosensitive conductive hydrogel. The surface of the thermosensitive conductive hydrogel is hydrophilic and highly viscous, making contact with and adhering to the nerve. The nerve signal is transmitted into the electrode through the conductive filler to complete the acquisition of intraoperative nerve potentials. After the signal measurement is completed, a fluid with a temperature higher than the phase transition temperature is introduced through the fluid injection component. The temperature of the thermosensitive conductive hydrogel rises, undergoes a phase transition, becomes hydrophobic, and its viscosity decreases, achieving non-adhesion and detachment from the nerve. The electrode clip can then be removed from the nerve measurement location. Because multiple nerves need to be continuously monitored during the procedure, the electrode clips are continued to be clamped onto the next nerve to be monitored. At this time, the temperature of the thermosensitive conductive hydrogel is higher than the phase transition temperature, and it is not sticky. It can easily wrap around the nerve without causing damage to the nerve. A fluid below the phase transition temperature is introduced, which lowers the temperature of the thermosensitive conductive hydrogel, causes a rapid phase transition, increases its viscosity, and allows it to adhere tightly to the nerve, helping to hold the nerve for nerve potential measurement and acquisition. After the measurement is completed, a fluid above the phase transition temperature is introduced, and the hydrogel simultaneously detaches and automatically separates from the nerve. The above process is repeated until the potential monitoring of all the nerves to be tested is completed.

[0054] The present invention relates to an adhesive adjustable hydrogel electrode clip for intraoperative nerve potential monitoring. By attaching a probe sleeve 101 made of temperature-sensitive conductive hydrogel to the electrode probe 102, the nerve is clamped for intraoperative nerve potential monitoring. The hydrogel has the characteristics of low modulus and small volume, which plays a buffering and protective role in the process of clamping the nerve. It can also sensitively sense temperature changes and make corresponding deformation responses of contraction or expansion according to temperature changes, and adjust its hydrophilicity, hydrophobicity and viscosity to achieve safe and non-destructive conformal coupling and benign separation between the hydrogel and the nerve. While achieving high-fidelity anti-artifact nerve potential signal acquisition, it can also effectively protect the nerve in the exposed state during surgery.

[0055] By using fluid to regulate temperature, continuous and precise temperature control is ensured, and the operation is simple, guaranteeing the safety and effectiveness of the surgical procedure.

[0056] Preferably, the fluid assembly includes two fluid pipes 104 respectively disposed on two clamping arms 103 along the length direction, with open ends. The outlet ends are respectively located above the corresponding probe sleeves 101, and the inlet ends are used to inject fluids of different temperatures. The fluid pipes 104 pass through the handle part 105 and are fixed by the handle part 105. Fluids of different temperatures are injected through the inlet ends, and the fluids are dripped onto the interface between the probe sleeve 101 and the nerve through the outlet ends. The temperature of the probe sleeve 101 is adjusted, which affects the hydrophilicity, hydrophobicity and viscosity of the temperature-sensitive conductive hydrogel, thereby achieving its close adhesion and separation from the nerve.

[0057] Preferably, the probe sleeve 101 is prepared by 3D printing mold, and the two probe sleeves 101 are nested and covered on the corresponding electrode probes 102 respectively.

[0058] Preferably, the fluid conduit 104 is made of polydimethylsiloxane (PDMS), and the mass ratio of the PDMS prepolymer to the curing agent is 10:1. The PDMS is added sequentially to a plastic cup and stirred continuously for 5 minutes to ensure uniform mixing of the curing agent and prepolymer. The mixture is then heated at 90°C for 2 hours using an existing mold, and the fluid conduit 104 is poured out. The fluid flowing through the fluid conduit 104 is a buffer solution (such as PBS buffer) or physiological saline. Different temperatures are pumped in to raise and lower the temperature, thereby controlling the hydrogel phase transition through heat transfer.

[0059] Preferably, the temperature-sensitive conductive hydrogel comprises a hydrogel framework composed of amide monomers, zwitterionic monomers and chitosan-gallic acid, and conductive fillers dispersed in the hydrogel framework.

[0060] Preferably, the amide monomer is one or more of N-vinylcaprolactam, acrylamide, or N-isopropylacrylamide; the zwitterionic monomer is 2-methacryloyloxyethylphosphorylcholine (MPC) or sulfobetaine methacrylate (SBMA); and the conductive filler is any one or more of PEDOT:PSS, polypyrrole, polyaniline, and their derivatives.

[0061] Preferably, the temperature-sensitive conductive hydrogel further includes a crosslinking agent and an initiator for achieving chemical crosslinking of amide monomers.

[0062] Preferably, the crosslinking agent is polyethylene glycol diacrylate (PEGDA).

[0063] Preferably, the initiator is one or more of α-ketoglutaric acid, Irgacure 2959, Irgacure 1173, TPO, and LAP.

[0064] Preferably, in the thermosensitive conductive hydrogel, the mass fractions of the amide monomer, zwitterionic monomer, chitosan-gallic acid, conductive filler, initiator, and crosslinking agent are 25 wt%-35 wt%, 5 wt%-15 wt%, 5 wt%-10 wt%, 2 wt%-8 wt%, 0.02 wt%-0.08 wt%, and 0.02 wt%-0.1 wt%, respectively.

[0065] The aforementioned amide monomers, phosphorylcholine zwitterionic monomers, chitosan-gallic acid, conductive fillers, initiators, and crosslinking agents are polymerized under ultraviolet light to form the aforementioned thermosensitive conductive hydrogel. The initiator decomposes under ultraviolet light irradiation to generate highly reactive free radicals. These free radicals initiate chain addition polymerization of the monomers. Simultaneously, the crosslinking agent crosslinks the polymer chains together, forming a three-dimensional crosslinked network. During this process, the thermosensitive polyamide polymers integrated into the crosslinked network through free radical reactions affect the hydrogel's temperature responsiveness and hydrophilicity. The zwitterionic monomers enhance the hydrophilicity and lubricity of the hydrogel and regulate its anti-swelling ability. Chitosan-gallic acid (CS-GA) further enhances the hydrogel's viscosity, and the conductive filler, uniformly dispersed within the hydrogel, imparts excellent conductivity.

[0066] The modulus of the aforementioned thermosensitive conductive hydrogel matches that of the tissue, which can play a buffering and protective role during clamping. The conductive filler in the hydrogel provides ion channels to transmit nerve electrical signals to the electrode probe 102.

[0067] The temperature responsiveness of the aforementioned thermosensitive conductive hydrogel is caused by a temperature-mediated hydrophilic-hydrophobic transition in the polymer chains. The principle of viscosity modulation of the temperature-responsive hydrogel is illustrated in the diagram below. Figure 5 As shown, specifically, the thermosensitive amide polymer chain has both hydrophobic isopropyl groups and hydrophilic amide groups. When it is necessary to test nerve potentials during surgery, the ambient temperature is controlled below the phase transition temperature. At this time, the pyrogallol groups in the thermosensitive conductive hydrogel form Michael addition, Schiff base reaction and hydrogen bonds. The zwitterionic groups form electrostatic coupling effects with the carboxyl and amino groups at the nerve interface. The amide groups in the thermosensitive amide polymer chain form hydrogen bonds with solvent molecules, which increases the affinity between the polymer chain and the solvent, causing the polymer chain to extend. With the increase of the macroscopic volume of the gel, the thermosensitive conductive hydrogel 308 before the phase transition exhibits hydrophilic properties, with reduced impedance and increased viscosity. It comes into contact with the nerve and adheres to the nerve. The conductive filler transmits the signal to the electrode probe, which can complete the acquisition of nerve potential signals. After the signal measurement is completed, a fluid above the phase transition temperature is introduced into the fluid pipe 104. The fluid flows to the interface between the probe sleeve 101 and the nerve, causing the temperature of the thermosensitive conductive hydrogel to rise. When the hydrogel temperature exceeds the phase transition temperature, the long chains of the polyamide polymer aggregate, and the hydrogel undergoes a phase transition, resulting in an increase in the interfacial layer modulus, tighter chain entanglement, and the destruction of hydrogen bonds. The amide groups in the thermosensitive amide polymer chains dehydrate, leading to enhanced hydrophobic interactions between the isopropyl side chains. The polymer chains form a tightly contracted state. The probe sleeve 101 made of the thermosensitive conductive hydrogel 308 after the phase transition exhibits a hydrophobic state. The hydrogen bonds inside the hydrogel break, expelling water, reducing viscosity, and detaching from the nerve. The electrode clip can then be removed from the nerve measurement location.

[0068] Preferably, the amide monomer is N-vinylcaprolactam (PNIPAM), the initiator is α-ketoglutarate, the crosslinking agent is PEGDA, and the conductive filler is PEDOT:PSS. Taking this example, the preparation method of the thermosensitive conductive hydrogel is described, and the preparation process is as follows: Figure 4 As shown:

[0069] S1: Dissolve 5-10 mmol of 2-morpholinoethanesulfonic acid (MES) and 5-10 mmol of NaCl in 100 ml of deionized water and adjust the pH to 5.5 to obtain MES mixture 301;

[0070] S2: Dissolve 2-4g of chitosan (CS) in the above MES mixture 301 with a pH of 5.5 and stir thoroughly until uniformly dissolved to obtain chitosan (CS) solution 302;

[0071] S3: Slowly dissolve 10-20 mmol of gallic acid (GA) in 20 ml of MES solution, add 5-10 ml of ethanol, add 10-20 mmol of 1-ethyl-(3-dimethylaminopropyl)carbodiimide hydrochloride and 10-20 mmol of N-hydroxythiosuccinimide, stir magnetically for 0.5-1 h to activate the carboxyl group, and obtain gallic acid (GA) solution 303;

[0072] S4: Add the above gallic acid (GA) solution 303 to chitosan (CS) solution 302, mix thoroughly, degas, seal and stir thoroughly for 12 hours, dialyze for 48 hours and freeze dry to obtain chitosan-gallic acid (CS-GA) polymer chains.

[0073] S5: Dissolve 2g of N-isopropylacrylamide (NIPAM) monomer, 0.2g of 2-methacryloyloxyethylphosphorylcholine (MPC) zwitterionic monomer, and 4 mmol-16 mmol of PEDOT:PSS in 10ml of deionized water to obtain the original mixture 304. Stir magnetically until the solution is uniformly mixed, then add chitosan-gallic acid (CS-GA) polymer chain and stir magnetically until uniform.

[0074] S6: Add 0.02-0.04 wt% polyethylene glycol diacrylate (PEGDA) and 0.03-0.05 wt% α-ketoglutaric acid to the above solution in sequence. After stirring magnetically until fully dissolved, degas for 10-15 min. Continue stirring in the dark to mix evenly to obtain pregel solution 305.

[0075] S7: Pour the above pregel solution 305 into the 3D printing mold 307 and place it under a UV lamp 306 with a wavelength of 360 nm for UV curing for 15 min. Then demold to finally obtain the temperature-sensitive conductive hydrogel 308.

[0076] A schematic diagram of the structure of the thermosensitive conductive hydrogel prepared above is shown in the figure. Figure 3 As shown, the hydrophilicity and hydrophobicity of the thermosensitive conductive hydrogel, poly(N-isopropylacrylamide) PNIPAM 201, are controlled by hydrogen bonds 205. The UV-photopolymerization mechanism involves the decomposition of a photoinitiator (α-ketoglutarate) under UV irradiation to generate free radicals. During this process, N-isopropylacrylamide, as a hydrophilic monomer, is integrated into the crosslinked network through reaction with free radicals on the polyethylene glycol diacrylate (PEGDA) 206 chain, affecting the gel's temperature responsiveness and hydrophilicity. These highly reactive free radicals then combine with the acrylate double bonds (C=C) in the N-isopropylacrylamide molecule, initiating a chain addition polymerization reaction. Since polyethylene glycol diacrylate (PEGDA)... Each molecule of 206 contains two acrylate groups, allowing these long chains to crosslink and form a three-dimensional crosslinked network, thus obtaining a thermosensitive conductive hydrogel. 2-Methacryloxyethylphosphorylcholine (MPC) 202 and chitosan-gallic acid (CS-GA) 203 are integrated into the three-dimensional crosslinked network. Poly(3,4-ethylenedioxythiophene)-polystyrene sulfonic acid PEDOT:PSS 204, as a conductive polymer, does not directly participate in the free radical polymerization reaction, but can be uniformly dispersed in the gel as a dispersed phase, giving the gel excellent conductivity.

[0077] The fluid introduced to regulate the temperature of the temperature-sensitive conductive hydrogel can be selected from buffer solution or physiological saline. Specifically, the buffer solution can be PBS buffer. Preferably, the phase transition temperature of the temperature-sensitive conductive hydrogel is 37°C, the high-temperature fluid introduced is 39°C, and the low-temperature fluid is 33°C.

[0078] Preferably, the electrode probe 102 has a small head and a large tail, with an arc-shaped inner surface in contact with the nerve. Its head is semi-circular or spherical to avoid stress concentration and potential brain injury. Specifically, the main body of the electrode probe can be conical or frustum-shaped. The distance between the tails of the two electrode probes 102, which are fitted with probe sleeves 101, is less than the diameter of the nerve, while the distance between their heads is greater than the diameter of the nerve, preventing external force from damaging the nerve.

[0079] Example 2

[0080] like Figure 2 and Figure 7As shown, this embodiment provides an adhesive adjustable hydrogel electrode clip for intraoperative nerve potential monitoring. Based on the structure of Embodiment 1, it also includes a back-end signal processing system 107 and a host computer system 108. The back-end signal processing system 107 is electrically connected to the electrode probe 102 through a data connection line 106 disposed in the clip arm 103 to receive nerve potential signals, analyze and process them, and then transmit them to the host computer system 108 for display and analysis via wireless or wired transmission.

[0081] According to the above scheme, the back-end signal processing system 107 includes a potential acquisition front-end module 605, a core processing module 606, a flexible battery 615, a power management chip 608, a wireless transmission module 610, and / or a standard wired interface. The flexible battery supplies power to the adhesively adjustable hydrogel electrode clip through the power management chip 608. The potential acquisition front-end module 605 is connected to the electrode probe 102 and the core processing module 606 respectively, and is used to receive the neural potential signals acquired by the electrode probe 102 and transmit them to the core processing module 606. The core processing module 606 is used to process the signals transmitted by the potential acquisition front-end module 605 and send them to the host computer system 108 through the wireless transmission module, or send them to the host computer system 108 through the standard wired interface.

[0082] The potential acquisition front-end module 605 integrates an operational amplifier, filter, and digital-to-analog converter to preprocess noisy data and extract the effective signal.

[0083] The back-end signal processing system 107 also includes a clock crystal module 607 and a program download module 609, which are respectively connected to the core processing module 606.

[0084] Optionally, standard wired interfaces include a serial port 611 and / or a USB interface 612.

[0085] According to the above scheme, the host computer system 108 includes a front-end display module and a back-end data processing and classification module. The front-end display module is used to view the current signal waveform and nerve potential status. The back-end data processing and classification module is used to process the nerve potential signal, distinguish between abnormal nerve potential signals and normal nerve potential signals, and score, map and bind them with the patient's prognosis, so as to realize the intraoperative judgment of nerve potential and provide functions for adding, deleting, modifying and querying, storing and exporting patients.

[0086] The nerve potential signal is amplified, filtered, and converted into a digital signal by the potential acquisition front-end module 605. After further processing by the core processing module 606, it is transmitted to the host computer system via the wireless transmission module 610 and / or a standard wired interface. The host computer analyzes the data in real time and performs signal review, waveform transformation, and classification to determine the current state of the nervous system. If an abnormal potential discharge signal is found, the operator is prompted to decide whether to continue the operation until the next nerve potential assessment.

[0087] The electrode clamp body 503 consists of an electrode probe 102, a probe sleeve 101, a clamp arm 103, a fluid pipe 104, a handheld part 105, and a data connection cable 106. The electrode clamp body 503, the back-end signal processing system 107, and the host computer system 108 can realize real-time monitoring of nerve potentials during surgery. By evaluating and analyzing the data, it can assist in assessing the nerve status during surgery, providing certain assistance and support to the surgeon. It can also judge the success of the surgery from the perspective of nerve potentials, thereby improving the success rate of surgery, avoiding secondary surgery due to nerve abnormalities, and helping the patient's prognosis and recovery.

[0088] The method of using electrode clips is as follows Figure 6 As shown, during the operation, the hand 501 holds the handpiece 105 of the instrument and maintains the holding state for at least 30 seconds to obtain a stable potential signal. The electrode clip body 503 is clamped to the root of the nerve 502. Because the nerve is fragile and sensitive, the temperature-sensitive conductive hydrogel interface remains in an adhesive state during the clamping process, so that the original potential signal can be transmitted normally to the back-end signal processing system 107 through the data connection line 106.

[0089] The back-end signal processing system 107 for the adhesive, adjustable hydrogel electrode clips used for intraoperative nerve potential monitoring Figure 7As shown, the temperature-sensitive conductive hydrogel 308 controls its phase transition by adjusting the temperature of the fluid 603 within the fluid conduit 104, thereby regulating its viscosity. The hydrogel transmits signals to the electrode probe 102 via an ion-conducting pathway. The clamp arm 103 is covered with insulating material and contains internal data connection lines. The electrode probe 102 is electrically connected to the potential acquisition front-end module 605 via data connection lines 106. The potential acquisition front-end module uses a dedicated chip, ADS1299, which can perform multi-channel 16kHz sampling rate data acquisition. The acquired signals are generally analog signals, which are converted into analyzable digital signals through analog-to-digital conversion (ADC). The converted signals communicate with the ADS1299 core processing module 606 via the SPI protocol. The core processing module 606 uses ADS1299 and integrates a clock management module, Bluetooth module, multiple ADCs, and rich interfaces such as SPI and I2C. The clock crystal oscillator module 607 includes a 32.768kHz timer clock circuit and a 32kHz high-speed clock. The backend signal processing system 107 is powered by a lithium-ion battery, button battery, or USB, and a stable voltage is provided by a power management chip 608, which uses both DC-DC and LDO methods. The core processing module 606 transmits data to the host computer via a wireless transmission module 610 and an RF antenna. The RF antenna supports multiple communication protocols, such as NFC, Bluetooth, and Wi-Fi bands, and employs AES encryption, RSA encryption, and MD5 verification to ensure data transmission security and stability. For ease of debugging, a wired communication interface, such as a serial port 611 (UART) or a USB interface 612, can also be provided for wired communication with the host computer. In one embodiment, the core processing module 606 requires the program to be burned and downloaded to the computer before data acquisition can be completed. The acquired data is transmitted to the host computer system 108. The host computer system 108 has an algorithm classification 613, and the specific algorithms include low-pass filtering, notch filtering, wavelet transform, binary classification, and tri-class classification. At the same time, the host computer system 108 has an alarm module. When there is an abnormality in the potential signal data received by the host computer system 108, the alarm module will activate the alarm.

[0090] The host computer system for the adhesive adjustable hydrogel electrode clip used for intraoperative nerve potential monitoring includes a host computer visualization interface written in Python and an internal algorithm program written in C++. The visualization interface includes a host computer waveform display interface, host computer setting control switches, and a status display bar. The host computer waveform display interface displays the currently measured potential waveform, allowing the doctor to determine the position of the clamped nerve in real time and providing the original abnormal discharge signal waveform. The signal includes two channels, channel_1 and channel_2, corresponding to the data collected by the two electrode probes 102 of the electrode clip, respectively. The host computer setting control switches include tools such as range display, setting, reminder, refresh, calibration, and export, providing corresponding interfaces for adding, deleting, modifying, and querying internal data streams. The status display bar includes three states: safe, warning, and abnormal, used to indicate the current measured state of the nerve location. If an abnormal potential signal is present, the doctor needs to intervene and adjust the tissue and nerve according to the surgical situation.

[0091] In addition to recording potential signals, the adhesive adjustable hydrogel electrode clip for intraoperative nerve potential monitoring can also connect the data connection line 106 to a stimulator to electrically stimulate the nerve, thereby inhibiting nerve conduction. Furthermore, the stimulation of nerve signals by the electrical stimulator can examine the conduction of the central and peripheral nerves and determine the location of nerve damage.

[0092] like Figure 8 The diagram shows a viscous, adjustable hydrogel electrode clip used for intraoperative nerve potential monitoring, which measures nerve conduction. A ~4.7Hz, ~10mA electrical stimulation current 802 is applied to both ends of the electrode clip using an electromyography evoked potential stimulator 801. Evoked potential signals are obtained at the nerve acquisition point 803 at the other end. The speed of nerve conduction can be obtained by measuring the distance and time between the two ends. This value is compared with conventional values ​​to determine whether nerve damage has occurred.

[0093] This invention utilizes nerve clamping during surgery to acquire the most original abnormal nerve potential signals. All components are sterile and fabricated using a mixture of rigid and flexible materials. The electrode probe 102, clamp arm 103, and handheld part 105 are made of rigid materials, meeting the needs of large-scale mass production. The surface hydrogel provides protection for the nerve and allows for high-quality signal acquisition and on-demand detachment through viscosity adjustment, ensuring safety and effectiveness. The system employs an ergonomic design, facilitating the surgeon's grip on the instruments and minimizing signal interference from external factors. The highly integrated back-end signal processing system 107 and data connection cable 106 form a stable electrical connection via soldering, ensuring high-fidelity data transmission. The electrode clamp features high fidelity, wide linear range, and low artifacts. The highly integrated board transmits signals to the host computer system 108 for display via reliable transmission protocols such as Bluetooth, Wi-Fi, and USB, allowing the surgeon to monitor the nerve clamping signal in real time, helping to determine surgical success and analyze abnormal nerve discharge states. This invention can collect abnormal data in a timely manner and provide alarm prompts, simultaneously informing the surgeon. This avoids surgical failure caused by abnormal potential signals remaining after suturing in neurosurgery. It also helps patients assess their prognosis and provides a monitoring method to improve surgical success rates and avoid secondary surgeries. It has profound significance in the protection of neurosurgical patients.

[0094] 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 viscous, adjustable hydrogel electrode clip for intraoperative nerve potential monitoring, characterized in that, include: Handheld part; Two clamping arms, each clamping arm including a fixed end and a clamping end, the fixed ends of the two clamping arms are respectively fixedly connected to the hand-held part, and the clamping ends are arranged opposite to each other; Two electrode probes are provided, each corresponding to one of the two clamping arms, with the tail of each electrode probe connected to the clamping end of its corresponding clamping arm. Each probe sleeve corresponds to one of the two electrode probes. Each probe sleeve is fitted onto its corresponding electrode probe and is in contact with the electrode probe. The two electrode probes with the probe sleeves are used to clamp the nerve during the operation and measure the nerve potential. The probe sleeves are made of temperature-sensitive conductive hydrogel, which has different viscosity at the phase transition temperature. A fluid injection assembly is used to inject fluids of different temperatures at the interface between the probe sleeve and the nerve, thereby controlling the temperature of the probe sleeve and its viscosity to achieve close contact and non-destructive separation between the probe sleeve and the nerve. The fluid injection assembly includes two fluid pipes arranged along the length of the two clamping arms. The outlet ends of the fluid pipes are located above the corresponding probe sleeves, and the inlet ends of the fluid pipes are used to inject fluids of different temperatures.

2. The adhesive-adjustable hydrogel electrode clip for intraoperative nerve potential monitoring according to claim 1, characterized in that, The temperature-sensitive conductive hydrogel comprises a hydrogel framework composed of amide monomers, zwitterionic monomers and chitosan-gallic acid, and conductive fillers dispersed in the hydrogel framework.

3. The adhesive-adjustable hydrogel electrode clip for intraoperative nerve potential monitoring according to claim 2, characterized in that, The amide monomer is one or more selected from N-vinylcaprolactam, acrylamide, or N-isopropylacrylamide; The zwitterionic monomer is 2-methacryloyloxyethyl phosphorylcholine or sulfobetaine methacrylate. The conductive filler is any one or more of PEDOT:PSS, polypyrrole, polyaniline and its derivatives.

4. The adhesive-adjustable hydrogel electrode clip for intraoperative nerve potential monitoring according to claim 2, characterized in that, The temperature-sensitive conductive hydrogel also includes a crosslinking agent and an initiator for achieving chemical crosslinking of amide monomers.

5. The adhesive-adjustable hydrogel electrode clip for intraoperative nerve potential monitoring according to claim 4, characterized in that, In the thermosensitive conductive hydrogel, the mass fractions of the amide monomer, zwitterionic monomer, chitosan-gallic acid, conductive filler, initiator, and crosslinking agent are 25 wt%-35 wt%, 5 wt%-15 wt%, 5 wt%-10 wt%, 2 wt%-8 wt%, 0.02 wt%-0.08 wt%, and 0.02 wt%-0.1 wt%, respectively.

6. The adhesive-adjustable hydrogel electrode clip for intraoperative nerve potential monitoring according to claim 1, characterized in that, The electrode probe has a small head and a large tail. The inner surface that contacts the nerve is curved. The head is semi-circular or spherical. The distance between the tails of the two electrode probes covered with probe sleeves is less than the diameter of the nerve, while the distance between the heads is greater than the diameter of the nerve.

7. The adhesive-adjustable hydrogel electrode clip for intraoperative nerve potential monitoring according to any one of claims 1 to 6, characterized in that, It also includes the back-end signal processing system and the host computer system; The back-end signal processing system is electrically connected to the electrode probe via a data connection line set in the clamp arm to receive nerve potential signals, analyze and process them, and then transmit them to the host computer system via wireless or wired transmission.

8. The adhesive-adjustable hydrogel electrode clip for intraoperative nerve potential monitoring according to claim 7, characterized in that, The back-end signal processing system includes a potential acquisition front-end module, a core processing module, a flexible battery, a power management chip, a wireless transmission module, and / or a standard wired interface. The flexible battery supplies power to the adhesively adjustable hydrogel electrode clips through the power management chip. The potential acquisition front-end module is connected to both the electrode probe and the core processing module, and is used to receive the neural potential signals acquired by the electrode probe and transmit them to the core processing module. The core processing module is used to process the signals transmitted by the potential acquisition front-end module and send them to the host computer system.

9. The adhesive-adjustable hydrogel electrode clip for intraoperative nerve potential monitoring according to claim 7, characterized in that, The host computer system includes a front-end display module and a back-end data processing and classification module. The front-end display module is used to view the current signal waveform and nerve potential status. The back-end data processing and classification module is used to process the nerve potential signal, distinguish between abnormal and normal nerve potential signals, score and map them with the patient's prognosis, realize the intraoperative judgment of nerve potential, and provide functions for adding, deleting, modifying, querying, storing and exporting patient information.

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