Viscous regulation and control hydrogel electrode clamp for monitoring intraoperative neural potential

Abstract

The invention provides a viscidity-adjustable hydrogel electrode holder for monitoring intraoperative neural potential. The viscidity-adjustable hydrogel electrode holder comprises a handheld part, a fluid assembly, two clamping arms, two electrode probes and two probe sleeves, the fixed ends of the two clamping arms are respectively and fixedly connected with the handheld part, the clamping ends of the two clamping arms are oppositely arranged, the tail parts of the two electrode probes are connected with the clamping ends of the corresponding clamping arms, the two probe sleeves are respectively sleeved on the electrode probes, the probe sleeves are made of temperature-sensitive conductive hydrogel, and the electrode probes sleeved with the probe sleeves are clamped on nerves and are used for measuring nerve potential. And the fluid injection assembly is used for injecting fluids with different temperatures into the contact interface of the probe sleeve and the nerve to regulate and control the viscosity of the temperature-sensitive conductive hydrogel. In the process that the electrode clamp clamps a nerve to perform intraoperative nerve potential monitoring, the electrode clamp adhesively adheres to the nerve to collect a high-fidelity potential signal, benign separation from the nerve is achieved after collection is finished, and the nerve is protected against damage.

Description

Technical Field

[0001] The present invention relates to the technical field of biomedical instruments, and in particular to a viscous and adjustable hydrogel electrode clip for intraoperative nerve potential monitoring. Background Art

[0002] The nervous system, comprising the central and peripheral nervous systems, performs highly complex functions, transmitting neural electrical signals and controlling human behavior. The brain contains hundreds of billions of neurons, connected by tens of trillions of synapses to form a vast neural network, making it the most complex organ in the human body. This network is structurally complex and functionally flexible, capable of rapidly responding to environmental changes and adapting to diverse tasks. Its working mechanisms and functions far exceed current human understanding. However, abnormal neuronal discharges lead to central and peripheral nervous system diseases such as Parkinson's disease, epilepsy, trigeminal neuralgia, and sciatica. These diseases affect hundreds of millions of people worldwide and impose a trillion-dollar annual economic burden on society. Neurosurgery is a key treatment for neurological diseases. It involves exposing the nerves and surrounding lesions, decompressing them, and implanting DBS, thereby minimizing postoperative pain and controlling opioid abuse.

[0003] Currently, neurosurgery for treating nerve lesions primarily relies on specialized physicians to determine whether there are any neurological abnormalities during surgery. This success rate is difficult to guarantee for different conditions. For example, surgery for neurological disorders involving the deep functional areas of the brain is more complex, resulting in lower success rates than for disorders involving the cerebral cortex. Trigeminal neuralgia is often caused by compression of nerves by blood vessels or tissue, leading to abnormal discharges that are transmitted to the sensory cortex and cause pain. These abnormal discharge signals are extremely small and difficult to detect because they are located within the brain tissue. Clinically, microvascular decompression is commonly used for treatment, with the primary goal of surgically removing or repositioning the vessels compressing the nerves, thereby reducing compression. However, during surgery, physicians rely solely on experience to determine the effectiveness of the treatment. The recurrence of abnormal discharge signals is crucial to the success of the surgery, but these signals cannot be obtained during surgery. Therefore, the success of the surgery is typically determined only after a comprehensive assessment of the patient's prognosis after suturing. This is extremely inconvenient for both the surgeon and the patient, and may necessitate a second surgery.

[0004] During neurosurgery, the location of the lesion is exposed, and the location of the nerve lesion can be directly and accurately located, which provides convenient conditions for obtaining signals. Due to the high difficulty and complexity of the operation, in order to avoid damaging the nerves, some flexible materials are usually used to cover the surface of the tissue to have a certain buffering effect, thereby achieving the purpose of protection. In addition to observing the patient's condition during surgery with the naked eye, intraoperative electrophysiology can perceive information about nerve potentials. Usually, a nerve probe is used to indirectly measure whether the evoked potential signal is abnormal. This method is usually used to protect nerves, provide timely feedback on human physiological indicators, and ensure the smooth progress of the operation. However, there is still no means of monitoring and judging to distinguish abnormal discharge signals found during surgery. This is because existing nerve probes are made of hard, rigid materials that are severely mismatched with the modulus of tissues and nerves. This heterogeneous and isomerous problem can easily lead to damage. As a result, the neuroelectrophysiological probe cannot fully clamp to the nerve root and cannot fully contact the nerve. The measured signal artifacts are large and completely covered by noise, making it impossible to complete the judgment of abnormal nerve signals. Therefore, using existing neuroelectrophysiological probes for intraoperative electrophysiological monitoring makes it difficult to determine the prognosis due to problems with the patient's own nervous system. In neurosurgery, identifying abnormal discharge signals and eliminating or weakening such abnormal discharges caused by nerve compression during surgery are extremely important for the success of the operation. Therefore, there is an urgent need for a device that can fully contact the nerve and is safe, reliable, and does not cause damage to the nerve to obtain stable potential signals.

[0005] Currently, myoelectric evoked potential (EMP) devices are commonly used to identify abnormal nerve signals. Signals at different locations can be divided into nerve conduction velocity, somatosensory evoked potentials, auditory evoked potentials, visual evoked potentials, motor evoked potentials, and electroencephalograms (EEGs). These testing methods cover a wide range of nerve measurement scenarios. However, the host computer typically transmits raw signals to the physician for evaluation and lacks automated analysis capabilities. Intraoperative nerve potentials require prompt assessment of surgical success to ensure they do not disrupt the procedure. This requires clamping the nerve to obtain a stable signal while also identifying abnormal nerve potentials. Summary of the Invention

[0006] In order to solve the problems existing in the background technology, the present invention provides a sticky and adjustable hydrogel electrode clamp for intraoperative nerve potential monitoring. Since the electrode clamp has a probe cover made of temperature-sensitive conductive hydrogel embedded on the probe, it can be adhesively attached to the nerve to collect high-fidelity potential signals during the process of clamping the nerve for intraoperative nerve potential monitoring. After the collection is completed, it can achieve benign separation from the nerve and protect the nerve from damage. The technical solution of the present invention to solve the above technical problems is as follows: The present invention provides a viscosity-regulatable hydrogel electrode clamp for intraoperative nerve potential monitoring, comprising a handheld part, a fluid injection assembly, two clamping arms, two electrode probes and two probe covers; each clamping arm comprises a fixed end and a clamping end, the fixed ends of the two clamping arms are respectively fixedly connected to the handheld part, the clamping ends are arranged opposite to each other, the two electrode probes are arranged in a one-to-one correspondence with the two clamping arms, the tail of each electrode probe is connected to the clamping end of its corresponding clamping arm, the two probe covers are arranged in a one-to-one correspondence with the two electrode probes, and are sleeved on the corresponding electrode probes and fit the electrode probes, the two electrode probes sleeved with the probe covers are used to clamp nerves during surgery and measure nerve potentials, the probe covers are made of temperature-sensitive conductive hydrogel, the temperature-sensitive conductive hydrogel is temperature-responsive, and has different viscosity and hydrophilicity above and below the phase change temperature, the fluid injection assembly is used to inject fluids of different temperatures at the interface where the probe cover contacts the nerve, regulate the temperature of the probe cover, and then regulate its viscosity, so as to achieve close fit and lossless separation with the nerve.

[0007] During surgery, the adhesive controllable hydrogel electrode clamp used for intraoperative nerve potential monitoring is clamped at the nerve root. At this time, the ambient temperature is lower than the phase change temperature of the thermosensitive conductive hydrogel. The surface of the thermosensitive conductive hydrogel is hydrophilic and highly viscous. It contacts and adheres to the nerve. The neural electrical signal is transmitted into the electrode probe through the probe cover made of the thermosensitive conductive hydrogel to complete the acquisition of the intraoperative nerve potential. After the signal measurement is completed, a fluid with a temperature higher than the phase change temperature is introduced through the fluid injection component. The fluid is dripped between the probe cover and the nerve interface. The temperature of the thermosensitive conductive hydrogel The temperature of the temperature-sensitive conductive hydrogel rises, a phase change occurs, and the hydrophobicity is manifested, and the viscosity is reduced, so that the electrode clamp is not adhered to the nerve and can be removed from the nerve measurement position; because multiple nerves need to be continuously monitored during the operation, the electrode clamp is continued to be clamped on the next nerve to be monitored, and a fluid below the phase change temperature is introduced to reduce the temperature of the temperature-sensitive conductive hydrogel and increase the viscosity, so that the hydrogel is closely attached to the nerve for measurement and collection of nerve potentials. After the measurement is completed, a fluid above the phase change temperature is introduced to separate the hydrogel from the nerve, and the above process is repeated until the potential monitoring of all nerves to be measured is completed.

[0008] Beneficial effects of the present invention: 1) The present invention's adhesively regulated hydrogel electrode clamp for intraoperative nerve potential monitoring achieves nerve clamping for intraoperative nerve potential monitoring by sheathing a probe cover made of a temperature-sensitive conductive hydrogel over an electrode probe. The hydrogel has the characteristics of low modulus and small volume. On the one hand, it can keenly sense temperature changes, responding to temperature changes by shrinking or expanding, and regulating its hydrophilicity and viscosity to achieve safe and non-destructive conformal coupling and benign detachment between the hydrogel and the nerve. On the other hand, it acts as a buffer and protector during the nerve clamping process. While achieving high-fidelity, artifact-free nerve potential signal acquisition, the electrode clamp can effectively protect the nerve during intraoperative exposure. 2) Temperature regulation by introducing fluid ensures continuous and precise temperature control, and is simple to operate, ensuring the safety and effectiveness of the surgical process.

[0009] 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 both ends open. The outlet ends are respectively located above the corresponding probe covers, and the inlet ends can be connected to an external circulation pump for injecting fluids of different temperatures.

[0010] According to the above scheme, the probe covers are prepared by a 3D printing mold, and the two probe covers are respectively nested and covered on the corresponding electrode probes.

[0011] According to the above scheme, the temperature-sensitive conductive hydrogel includes a hydrogel skeleton composed of amide monomers, zwitterionic monomers and chitosan-gallic acid, and conductive fillers dispersed in the hydrogel skeleton.

[0012] According to the above scheme, the amide monomer is one or more of N-vinylcaprolactam, acrylamide or N-isopropylacrylamide; the zwitterionic monomer is 2-methacryloyloxyethyl phosphorylcholine (MPC) or sulfobetaine methacrylate (SBMA); and the conductive filler is any one or more of PEDOT:PSS, polypyrrole, polyaniline and their derivatives.

[0013] According to the above solution, the temperature-sensitive conductive hydrogel further includes a cross-linking agent and an initiator for achieving chemical cross-linking of amide monomers.

[0014] According to the above scheme, the cross-linking agent is polyethylene glycol diacrylate (PEGDA).

[0015] According to the above scheme, the initiator is one or more of α-ketoglutaric acid, Irgacure 2959, Irgacure 1173, TPO and LAP.

[0016] According to the above scheme, in the temperature-sensitive conductive hydrogel, the mass fractions of the amide monomer, zwitterionic monomer, chitosan-gallic acid, conductive filler, initiator and cross-linker 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.

[0017] The thermosensitive conductive hydrogel is formed by UV-initiated polymerization of amide monomers, zwitterionic monomers, chitosan-gallic acid, conductive fillers, initiators, and crosslinkers. The initiator decomposes under UV light to produce highly reactive free radicals, which initiate chain addition polymerization of the monomers. Simultaneously, the crosslinker crosslinks the polymer chains together, forming a three-dimensional crosslinked network. During this process, the thermosensitive polyamide polymer, incorporated into the crosslinked network through free radical reactions, influences the hydrogel's temperature responsiveness, hydrophilicity, and viscosity. The zwitterionic monomer enhances the hydrogel's hydrophilicity and lubricity, regulating its anti-swelling properties. Chitosan-gallic acid (CS-GA) further enhances the hydrogel's viscosity. The conductive filler, uniformly dispersed throughout the hydrogel, imparts excellent conductivity to the hydrogel.

[0018] The temperature responsiveness of the thermosensitive conductive hydrogel is caused by the hydrophilic-hydrophobic transition of the polymer chain mediated by temperature.

[0019] Specifically, the thermosensitive amide polymer chain has both hydrophobic isopropyl groups and hydrophilic amide groups. When the nerve potential needs to be tested during surgery, the ambient temperature is controlled to be lower than the phase transition temperature. At this time, the pyrogallol groups in the thermosensitive conductive hydrogel form Michael addition, Schiff base reaction and hydrogen bonds with the nerve interface, and the zwitterionic groups form an electrostatic coupling effect with the carboxyl and amino groups at the nerve interface. The amide groups in the thermosensitive amide polymer chain form hydrogen bonds with the solvent molecules, increasing the affinity between the polymer chain and the solvent, causing the polymer chain to stretch. As the macroscopic volume of the gel increases, the thermosensitive conductive hydrogel exhibits hydrophilic properties, reduced impedance, enhanced viscosity, contacts the nerve and adheres to the nerve. The conductive filler transmits the signal to the electrode probe, thereby completing the collection of nerve potential signals. After the signal measurement is completed, a fluid with a temperature higher than the phase transition temperature is introduced into the fluid pipeline to increase the temperature of the thermosensitive conductive hydrogel. When the temperature of the hydrogel exceeds the phase transition temperature, the long chains of the polyamide polymers agglomerate and the hydrogel undergoes a phase change, resulting in an increase in the modulus of the interface layer, tighter chain entanglement, and destruction of hydrogen bonds. The amide groups in the thermosensitive amide polymer chains are dehydrated, resulting in an enhanced hydrophobic effect between the isopropyl side chains, and the polymer chains form a tightly contracted state. The probe cover made of the thermosensitive conductive hydrogel exhibits a hydrophobic state, the hydrogen bonds inside the hydrogel are broken, the water is discharged, the viscosity is reduced, and it is detached from the nerve, and the electrode clamp can be removed from the nerve measurement position.

[0020] The fluid introduced to control the temperature of the thermosensitive conductive hydrogel can be selected from a buffer solution or physiological saline solution. Specifically, the buffer solution can be PBS buffer. In one embodiment, the phase transition temperature of the thermosensitive conductive hydrogel is 37°C, the high-temperature fluid introduced is 39°C, and the low-temperature fluid introduced is 33°C.

[0021] In a specific embodiment, the amide monomer is N-isopropylacrylamide (NIPAM), the zwitterionic monomer is 2-methacryloyloxyethylphosphorylcholine zwitterionic monomer (MPC), the conductive filler is PEDOT:PSS, the crosslinking agent is polyethylene glycol diacrylate (PEGDA), and the initiator is α-ketoglutaric acid to prepare the above-mentioned temperature-sensitive conductive hydrogel. The preparation method of the temperature-sensitive conductive hydrogel is: S1: Dissolve 5-10 mmol 2-morpholinoethanesulfonic acid (MES) and 5-10 mmol NaCl in 100 ml deionized water and adjust the pH to 5.5 to prepare MES buffer. S2: Dissolve 2-4 g of chitosan (CS) in the above MES solution with a pH of 5.5 and stir thoroughly until uniformly dissolved; S3: Slowly dissolve 10-20 mmol of gallic acid (GA) in 20 ml of MES solution, add 5-10 ml of ethanol, 10-20 mmol of 1-ethyl-(3-dimethylaminopropyl)carbodiimide hydrochloride, and 10-20 mmol of N-hydroxysulfosuccinimide, and stir magnetically for 0.5-1 h to activate the carboxyl groups. 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 then freeze-dry to obtain chitosan-gallic acid (CS-GA) polymer chain; S5: Dissolve 4 g of N-isopropylacrylamide (NIPAM) monomer, 1 g of 2-methacryloyloxyethyl phosphorylcholine zwitterionic monomer (MPC), and 4 mmol-16 mmol of PEDOT:PSS in 10 ml of deionized water. Stir magnetically until the solution is uniformly mixed. Then, add 1 g of chitosan-gallic acid (CS-GA) adhesive functional polymer chain and stir magnetically until uniform. S6: 0.02-0.1 wt% polyethylene glycol diacrylate (PEGDA) and 0.02-0.08 wt% α-ketoglutaric acid were added to the above solution in sequence, and the mixture was thoroughly stirred with magnetic stirring and then degassed for 10-15 minutes. Stirring was continued in the dark to obtain a pre-gel solution; S7: Pour the above pre-gel solution into a mold and place it under a UV lamp with a wavelength of 360 nm for UV curing for 15 minutes, then demold the mold to finally obtain a temperature-sensitive conductive hydrogel.

[0022] According to the above scheme, the head of the electrode probe is small, the tail is large, the inner side contacting the nerve is an arc surface, and the head is a semicircular head or a spherical head to avoid stress concentration causing brain damage.

[0023] The distance between the tails of the two electrode probes covered with the probe cover is smaller than the nerve diameter, and the distance between the heads is larger than the nerve diameter.

[0024] According to the above scheme, the adhesive controllable hydrogel electrode clamp used 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 arranged in the clamp arm to receive the nerve potential signal, and transmits it to the host computer system through wireless or wired transmission after analysis and processing.

[0025] 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 powers the viscosity-regulating hydrogel electrode clamp 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 signal collected by the electrode probe and transmit it to the core processing module. The core processing module is used to process the signal transmitted by the potential acquisition front-end module and send it to the host computer system.

[0026] 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, and the back-end data processing and classification module is used to process the nerve potential signal to distinguish between abnormal nerve potential signals and normal nerve potential signals, and to score, map and bind them with the patient's prognosis to realize the intraoperative judgment of the nerve potential, and provide the functions of adding, deleting, modifying, checking, storing and exporting patient information.

[0027] The electrode clamp body consists of an electrode probe, a probe cover, a clamp arm, a fluid pipeline, a handpiece and a data connection line. The electrode clamp body, the back-end signal processing system and the host computer system can realize real-time monitoring of intraoperative nerve potentials. By evaluating and analyzing the data, it assists in evaluating the nerve status during surgery, provides certain assistance and support to the surgical operator, and can judge the success of the operation from the perspective of nerve potential, thereby improving the success rate of the operation, avoiding secondary surgery due to nerve abnormalities, and helping the patient's prognosis recovery. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 This is a schematic structural diagram of an adhesively adjustable hydrogel electrode clip for intraoperative nerve potential monitoring according to Example 1 of the present invention; Figure 2 This is a schematic structural diagram of an adhesively adjustable hydrogel electrode clip for intraoperative nerve potential monitoring according to Example 2 of the present invention; Figure 3 Schematic diagram of the interface of the temperature-sensitive conductive hydrogel according to Example 1 of the present invention; Figure 4 Schematic diagram of the preparation process of the temperature-sensitive conductive hydrogel according to Example 1 of the present invention; Figure 5 This is a schematic diagram of the viscosity control principle of the temperature-sensitive conductive hydrogel according to Example 1 of the present invention; Figure 6 This is a schematic diagram of a method for using the adhesively adjustable hydrogel electrode clip for intraoperative nerve potential monitoring according to Example 2 of the present invention; Figure 7This is a rear-end electrical schematic diagram of the adhesively adjustable hydrogel electrode clip for intraoperative nerve potential monitoring according to Example 2 of the present invention; Figure 8 Schematic diagram of nerve conduction measurement using an adhesively adjustable hydrogel electrode clamp for intraoperative nerve potential monitoring according to the present invention.

[0029] In all figures, the same reference numerals are used to represent the same elements or structures, where: 101 is a probe cover; 102 is an electrode probe; 103 is a clamp arm; 104 is a fluid pipeline; 105 is a handheld part; 106 is a data connection line; 107 is a back-end signal processing system; 108 is a host computer system; 201 is poly (N-isopropylacrylamide) PNIPAM; 202 is 2-methacryloyloxyethyl phosphorylcholine (MPC) ; 203 is chitosan-gallic acid (CS-GA); 204 is poly (3,4-ethylenedioxythiophene) - polystyrene sulfonate PEDOT:PSS; 205 is hydrogen bond; 206 is polyethylene glycol diacrylate PEGDA; 301 is MES mixed solution; 302 is chitosan (CS) solution; 303 is gallic acid (GA) solution; 304 is the original mixed solution; 305 is pre-gel 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 clamp 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 DESCRIPTION

[0030] 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 used to explain the present invention and are not used to limit the scope of the present invention.

[0031] Example 1 like Figure 1As shown, this embodiment provides a sticky controllable hydrogel electrode clamp for intraoperative nerve potential monitoring, including a handheld portion 105, a fluid injection component, two clamping arms 103, two electrode probes 102 and two probe covers 101; the handheld portion 105 is used 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 handheld portion 105, and the clamping ends are arranged opposite to each other, the two electrode probes 102 are arranged in a one-to-one correspondence with the two clamping arms 103, and their tails are fixedly connected to the clamping ends of the corresponding clamping arms 103, the two probe covers 101 are arranged in a one-to-one correspondence with the two electrode probes 102, and are sleeved on the corresponding electrode probes by interference fit. The pole probe 102 is physically connected to the electrode probe 102, and the electrode probe 102 and the clamping arm are electrically connected using an integrated molding process, which is used to clamp nerves, measure nerve potentials and transmit potential signals. The two electrode probes 102 with the probe cover 101 are used to clamp nerves during surgery and measure nerve potentials. The probe cover 101 is made of a temperature-sensitive conductive hydrogel, which is temperature-responsive and has different viscosity and hydrophilicity above and below the phase change temperature. The fluid injection component is used to inject fluids of different temperatures into the interface where the probe cover 101 contacts the nerve, regulates the temperature of the probe cover 101, and then regulates its viscosity to achieve close fit and lossless separation with the nerve.

[0032] Since the temperature of the brain tissue is about 37°C, the phase transition temperature of the above-mentioned temperature-sensitive conductive hydrogel is set to 36~38°C. When the temperature is lower than the phase transition temperature, the probe cover 101 made of the temperature-sensitive conductive hydrogel is hydrophilic, has high viscosity, and is tightly attached to the nerves; when the temperature is higher than the phase transition temperature, the probe cover 101 made of the temperature-sensitive conductive hydrogel is hydrophobic, has low viscosity, and is debonded from the nerves.

[0033] A data connection line 106 is provided in the clamping arm 103 , one end of which is connected to the electrode probe 102 , and the other end of which passes through the handheld portion 105 .

[0034] During surgery, the sticky, controllable hydrogel electrode clamp used for intraoperative nerve potential monitoring is clamped at the nerve root. At this time, the ambient temperature is lower than the phase change temperature of the thermosensitive conductive hydrogel. The surface of the thermosensitive conductive hydrogel is hydrophilic and highly viscous. It contacts the nerve and adheres to the nerve. The nerve signal is transmitted into the electrode through the conductive filler to complete the collection of intraoperative nerve potential. After the signal measurement is completed, a fluid with a temperature higher than the phase change temperature is introduced through the fluid injection component. The temperature of the thermosensitive conductive hydrogel rises, a phase change occurs, and it becomes hydrophobic and the viscosity decreases, achieving non-adhesion and detachment from the nerve. The electrode clamp can be removed from the nerve measurement position. Since multiple nerves need to be continuously monitored during the operation, the electrode clamp continues to be clamped on the next nerve that needs to be monitored. At this time, the temperature of the thermosensitive conductive hydrogel is higher than the phase change temperature and has no viscosity. It can be easily wrapped around the nerve without causing damage to the nerve. Fluid below the phase change temperature is introduced to lower the temperature of the thermosensitive conductive hydrogel, causing a rapid phase change and increased viscosity, allowing it to adhere tightly to the nerve, assisting in clamping the nerve for measurement and collection of nerve potentials. After the measurement is completed, fluid above the phase change temperature is introduced, causing the hydrogel to debond synchronously and automatically detach from the nerve. The above process is repeated until the potential monitoring of all nerves to be tested is completed.

[0035] The present invention provides a hygroscopically regulated hydrogel electrode clamp for intraoperative nerve potential monitoring. By sheathing a probe cover 101 made of a temperature-sensitive conductive hydrogel over an electrode probe 102, the clamp achieves nerve clamping for intraoperative nerve potential monitoring. The hydrogel has the characteristics of low modulus and small volume, providing a buffering and protective effect during nerve clamping. Furthermore, the hydrogel can sensitively sense temperature changes, responding to temperature changes by contracting or expanding, and regulating its hydrophilicity and viscosity to achieve safe and lossless conformal coupling and benign separation between the hydrogel and the nerve. This allows for the acquisition of high-fidelity, artifact-free nerve potential signals while effectively protecting the nerve during intraoperative exposure. By introducing fluid to adjust the temperature, it ensures sustainable and precise temperature control and is easy to operate, thus ensuring the safety and effectiveness of the surgical process.

[0036] Preferably, the fluid component includes two fluid pipes 104 respectively arranged on the two clamping arms 103 along the length direction, with both ends open, the outlet ends are respectively located above the corresponding probe covers 101, and the inlet ends are used to inject fluids of different temperatures. The fluid pipes 104 pass through the handheld part 105 and are fixed by the handheld part 105. Fluids of different temperatures are injected through the inlet ends, and the fluids are dripped onto the interface where the probe cover 101 contacts the nerve through the outlet ends, thereby regulating the temperature of the probe cover 101, affecting the hydrophilicity and viscosity of the temperature-sensitive conductive hydrogel, and thereby achieving its close fit and separation with the nerve.

[0037] Preferably, the probe covers 101 are formed by a 3D printing mold, and the two probe covers 101 are nested and covered on the corresponding electrode probes 102 respectively.

[0038] Preferably, fluid conduit 104 is made of polydimethylsiloxane (PDMS), with a mass ratio of 10:1 between the PDMS prepolymer and the curing agent. The mixture 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 passed through a mold, heated at 90°C for 2 hours, and poured out of the corresponding fluid conduit 104. Fluids such as buffer (e.g., PBS buffer) and saline are introduced into the fluid conduit 104. Fluids of varying temperatures are pumped in to increase and decrease the temperature, thereby controlling the hydrogel phase transition through heat transfer.

[0039] Preferably, the temperature-sensitive conductive hydrogel includes a hydrogel skeleton composed of amide monomers, zwitterionic monomers and chitosan-gallic acid, and a conductive filler dispersed in the hydrogel skeleton.

[0040] Preferably, the amide monomer is one or more of N-vinylcaprolactam, acrylamide or N-isopropylacrylamide; the zwitterionic monomer is 2-methacryloyloxyethyl phosphorylcholine (MPC) or sulfobetaine methacrylate (SBMA); and the conductive filler is any one or more of PEDOT:PSS, polypyrrole, polyaniline and their derivatives.

[0041] Preferably, the temperature-sensitive conductive hydrogel further comprises a cross-linking agent and an initiator for achieving chemical cross-linking of amide monomers.

[0042] Preferably, the cross-linking agent is polyethylene glycol diacrylate (PEGDA).

[0043] Preferably, the initiator is one or more of α-ketoglutaric acid, Irgacure 2959, Irgacure 1173, TPO and LAP.

[0044] Preferably, in the temperature-sensitive conductive hydrogel, the mass fractions of the amide monomer, zwitterionic monomer, chitosan-gallic acid, conductive filler, initiator and cross-linker 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.

[0045] The thermosensitive conductive hydrogel is formed by UV-initiated polymerization of the amide monomers, phosphorylcholine zwitterionic monomers, chitosan-gallic acid, conductive fillers, initiators, and crosslinkers. The initiator decomposes under UV light to produce highly reactive free radicals, which initiate chain addition polymerization of the monomers. Simultaneously, the crosslinker crosslinks the polymer chains together to form a three-dimensional crosslinked network. During this process, the thermosensitive polyamide polymer, incorporated into the crosslinked network via free radical reactions, influences the hydrogel's temperature responsiveness and hydrophilicity. The zwitterionic monomers enhance the hydrogel's hydrophilicity and lubricity, regulating its anti-swelling properties. The chitosan-gallic acid (CS-GA) further enhances the hydrogel's viscosity. The conductive filler, uniformly dispersed throughout the hydrogel, imparts excellent conductivity to the hydrogel.

[0046] The modulus of the temperature-sensitive conductive hydrogel matches the tissue modulus, and can play a buffering and protective role during the clamping process. The conductive filler in the hydrogel provides an ion channel to transmit neural electrical signals to the electrode probe 102.

[0047] The temperature responsiveness of the thermosensitive conductive hydrogel is caused by the hydrophilic-hydrophobic transition of the polymer chain mediated by temperature. The principle diagram of the viscosity regulation of the temperature-responsive hydrogel is shown in the figure below. Figure 5 As shown, specifically, the thermosensitive amide polymer chain has both hydrophobic isopropyl groups and hydrophilic amide groups. When the nerve potential needs to be tested during surgery, the ambient temperature is controlled to be lower than the phase transition temperature. At this time, the pyrogallol groups in the thermosensitive conductive hydrogel form Michael addition, Schiff base reaction and hydrogen bonds, and the zwitterionic groups form an electrostatic coupling effect with the carboxyl and amino groups at the interface of the nerve. The amide groups in the thermosensitive amide polymer chain form hydrogen bonds with the solvent molecules, which increases the affinity between the polymer chain and the solvent, allowing the polymer chain to stretch. As the macroscopic volume of the gel increases, the thermosensitive conductive hydrogel 308 before the phase change shows hydrophilic properties, reduced impedance, enhanced viscosity, contacts with the nerve and adheres to the nerve. The conductive filler transmits the signal to the electrode probe, which can complete the collection of the nerve potential signal. After the signal measurement is completed, a fluid with a temperature higher than the phase transition temperature is introduced into the fluid conduit 104. The fluid flows to the interface between the probe cover 101 and the nerve, causing the temperature of the thermosensitive conductive hydrogel to rise. When the temperature of the hydrogel exceeds the phase transition temperature, the long chains of the polyamide polymers agglomerate and the hydrogel undergoes a phase transition, resulting in an increase in the modulus of the interface layer, tighter chain entanglement, and destruction of hydrogen bonds. The amide groups in the thermosensitive amide polymer chains are dehydrated, resulting in an enhanced hydrophobic effect between the isopropyl side chains, and the polymer chains form a tightly contracted state. The probe cover 101 made of the thermosensitive conductive hydrogel 308 after the phase transition exhibits a hydrophobic state, the hydrogen bonds inside the hydrogel are broken, the water is discharged, the viscosity is reduced, and it is no longer adhered to the nerve and detached, and the electrode clip can be removed from the nerve measurement position.

[0048] Preferably, the amide monomer is N-vinyl caprolactam (PNIPAM), the initiator is α-ketoglutaric acid, the crosslinker is PEGDA, and the conductive filler is PEDOT:PSS. The preparation method of the temperature-sensitive conductive hydrogel is described as follows: Figure 4 As shown: S1: Dissolve 5-10 mmol 2-morpholineethanesulfonic acid (MES) and 5-10 mmol NaCl in 100 ml deionized water and adjust the pH to 5.5 to obtain a MES mixture 301; S2: Dissolve 2-4 g of chitosan (CS) in the MES mixed solution 301 with a pH of 5.5 and stir thoroughly until uniformly dissolved to obtain a chitosan (CS) solution 302; S3: Slowly dissolve 10-20 mmol of gallic acid (GA) in 20 ml of MES solution, add 5-10 ml of ethanol, 10-20 mmol of 1-ethyl-(3-dimethylaminopropyl)carbodiimide hydrochloride, and 10-20 mmol of N-hydroxysulfosuccinimide. Stir magnetically for 0.5-1 h to activate the carboxyl groups, obtaining gallic acid (GA) solution 303. S4: Add the gallic acid (GA) solution 303 to the chitosan (CS) solution 302, mix thoroughly, degas, seal, and stir thoroughly for 12 hours, dialyze for 48 hours, and then freeze-dry to obtain a chitosan-gallic acid (CS-GA) polymer chain; S5: 2 g of N-isopropylacrylamide (NIPAM) monomer, 0.2 g of 2-methacryloyloxyethyl phosphorylcholine (MPC) zwitterionic monomer, and 4 mmol-16 mmol of PEDOT:PSS were dissolved in 10 ml of deionized water to obtain the original mixed solution 304. The solution was magnetically stirred until the solution was uniformly mixed, and then chitosan-gallic acid (CS-GA) polymer chain was added and magnetically stirred until uniformly mixed. S6: 0.02-0.04 wt% polyethylene glycol diacrylate (PEGDA) and 0.03-0.05 wt% α-ketoglutaric acid were added to the above solution in sequence, and the mixture was thoroughly stirred with magnetic stirring and then degassed for 10-15 min. Stirring was continued in the dark to obtain a pre-gel solution 305; S7: Pour the pre-gel solution 305 into a 3D printing mold 307 and place it under a UV lamp 306 with a wavelength of 360 nm for UV curing for 15 minutes, then demold the mold to finally obtain a temperature-sensitive conductive hydrogel 308.

[0049] The structural diagram of the thermosensitive conductive hydrogel prepared above is shown in FIG. Figure 3As shown, the poly (N-isopropylacrylamide) PNIPAM 201 of the thermosensitive conductive hydrogel controls its hydrophilicity and hydrophobicity through hydrogen bonds 205. The UV polymerization mechanism is that the photoinitiator (α-ketoglutaric acid) decomposes under UV light to produce free radicals. In this process, N-isopropylacrylamide, as a hydrophilic monomer, reacts with free radicals on the polyethylene glycol diacrylate PEGDA 206 chain and is integrated into the cross-linked network, affecting the temperature responsiveness and hydrophilicity of the gel; the highly active free radicals then combine with the acrylate double bond (C=C) in the N-isopropylacrylamide molecule to initiate a chain addition polymerization reaction. Due to the Each molecule of 206 contains two acrylate groups, so these long chains can be cross-linked to form a three-dimensional cross-linked network, thereby obtaining a thermosensitive conductive hydrogel. 2-Methacryloyloxyethyl phosphorylcholine (MPC) 202 and chitosan-gallic acid (CS-GA) 203 are integrated into the three-dimensional cross-linked network. Poly(3,4-ethylenedioxythiophene)-polystyrenesulfonic 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 in the form of a dispersed phase to give the gel excellent conductivity.

[0050] The fluid introduced into the thermosensitive conductive hydrogel to control its temperature can be selected from a buffer solution or physiological saline solution. Specifically, the buffer solution can be PBS. Preferably, the phase transition temperature of the thermosensitive conductive hydrogel is 37°C, the high-temperature fluid introduced is 39°C, and the low-temperature fluid introduced is 33°C.

[0051] Preferably, the electrode probe 102 has a small head and a large tail. The inner side that contacts the nerve is a curved surface. The head is semicircular or spherical to avoid stress concentration and brain damage. Specifically, the main body of the electrode probe can be conical or truncated cone-shaped. The distance between the tails of the two electrode probes 102, which are covered with the probe cover 101, is less than the diameter of the nerve, while the distance between the heads is greater than the diameter of the nerve to avoid damage to the nerve caused by external forces.

[0052] Example 2 like Figure 2 and Figure 7 As shown, this embodiment provides a sticky controllable hydrogel electrode clamp for intraoperative nerve potential monitoring. Based on the structure of Example 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 via a data connection line 106 provided in the clamp arm 103 to receive the nerve potential signal, and after analyzing and processing the signal, transmits it to the host computer system 108 for display and analysis via wireless or wired transmission.

[0053] 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 powers 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 signal collected by the electrode probe 102 and transmit it to the core processing module 606. The core processing module 606 is used to process the signal transmitted by the potential acquisition front-end module 605 and send it to the host computer system 108 through the wireless transmission module, or send it to the host computer system 108 through the standard wired interface.

[0054] The potential acquisition front-end module 605 integrates an operational amplifier, a filter, and a digital-to-analog conversion device to pre-process the noisy data to extract the effective signal.

[0055] The back-end signal processing system 107 further includes a clock crystal oscillator module 607 and a program download module 609 , which are connected to the core processing module 606 respectively.

[0056] Optionally, the standard wired interface includes a serial port 611 and / or a USB port 612 .

[0057] 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, and the back-end data processing and classification module is used to process the nerve potential signal to distinguish between abnormal nerve potential signals and normal nerve potential signals, and to score, map and bind them with the patient's prognosis to realize the intraoperative judgment of the nerve potential, and provide the functions of adding, deleting, modifying, checking, storing and exporting patients.

[0058] 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, reviews the signal, transforms the waveform, and classifies it to determine the current state of the nervous system. If abnormal potential discharge signals are detected, the operator is prompted to decide whether to continue the operation until the next nerve potential determination.

[0059] The electrode probe 102, probe cover 101, clamp arm 103, fluid pipeline 104, handheld part 105 and data connection line 106 constitute the electrode clamp body 503. Through the electrode clamp body 503, the back-end signal processing system 107 and the host computer system 108, real-time monitoring of intraoperative nerve potential can be achieved. Through the evaluation and analysis of the data, it assists in the evaluation of the nerve status during the operation, provides certain assistance and support to the surgical operator, and can judge the success of the operation from the perspective of nerve potential, thereby improving the success rate of the operation, avoiding secondary surgery due to nerve abnormalities, and contributing to the patient's prognosis recovery.

[0060] How to use the electrode clamp Figure 6 As shown, during the operation, the hand 501 holds the handpiece 105 of the instrument, and its holding state is maintained unchanged for at least 30 seconds to obtain a stable potential signal. The electrode clamp body 503 is clamped to the root of the nerve 502. Since the nerve is fragile and sensitive, the temperature-sensitive conductive hydrogel interface remains in an adhesion state during the clamping process, so that the original potential signal can be normally transmitted to the back-end signal processing system 107 through the data connection line 106.

[0061] Back-end signal processing system 107 of adhesively regulated hydrogel electrode clamp for intraoperative neural potential monitoring Figure 7As shown, the temperature-sensitive conductive hydrogel 308 controls its phase change by the temperature of the fluid 603 in the fluid conduit 104, thereby regulating its viscosity. The hydrogel transmits signals to the electrode probe 102 through an ionic conductive pathway. The clamping arm 103 is covered with an insulating material and internally provided with a data connection line. The electrode probe 102 is electrically connected to the potential acquisition front-end module 605 via the data connection line 106. The potential acquisition front-end module uses a dedicated chip ADS1299, which can perform multi-channel data acquisition at a 16kHz sampling rate. 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 the ADS1299 and integrates a clock management module, a Bluetooth module, multiple ADCs, and a variety of 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 back-end signal processing system 107 is powered by a lithium-ion battery, button cell, or USB. A stable voltage is provided by the power management chip 608, which utilizes a DC-DC converter and low-dropout (LDO) approach. The core processing module 606 transmits data to a host computer via a wireless transmitter module 610 and a radio frequency antenna. The radio frequency antenna supports a variety of communication protocols, such as NFC, Bluetooth, and Wi-Fi. It utilizes AES encryption, RSA encryption, and MD5 integrity verification to ensure data transmission security and stability. To facilitate debugging, a wired communication interface, such as a serial port 611 (UART) or USB port 612, is also provided for wired communication with the host computer. In one embodiment, the core processing module 606 requires the program to be downloaded to the computer before data collection can be completed. The collected data is transmitted to the host computer system 108. The host computer system 108 is internally provided with an algorithm classification 613. The specific algorithms include low-pass filtering, notch filtering, wavelet transform, binary classification, ternary classification, etc. At the same time, the host computer system 108 is provided with an alarm module. When there is an abnormality in the potential signal data received in the host computer system 108, the alarm module activates the alarm.

[0062] The host computer system of the adhesive controllable hydrogel electrode clamp for intraoperative nerve potential monitoring includes a host computer visualization interface written in Python and an algorithm program written in internal C++. The visualization interface includes a host computer waveform display interface, a host computer setting control switch, and a status display bar. The host computer waveform display interface is used to display the currently measured potential waveform, which allows doctors to determine the position of the clamped nerve in real time and provide the original abnormal discharge signal waveform. The signal includes two channels, channel_1 and channel_2, which correspond to the data collected by the two electrode probes 102 of the electrode clamp respectively. The host computer setting control switch includes range display, setting, reminder, refresh, calibration, export and other tools, which provide corresponding interfaces for adding, deleting, modifying and checking internal data streams. The status display bar includes three states, namely safety, warning and abnormality, which are used to indicate the status measured at the current nerve point. If there is an abnormal potential signal, the doctor needs to intervene and adjust the tissue and nerve according to the situation of the operation.

[0063] In addition to recording potential signals, the adhesive controllable hydrogel electrode clamp used for intraoperative nerve potential monitoring can also connect the data connection line 106 to the stimulator to electrically stimulate the nerves, thereby inhibiting nerve conduction. In addition, the stimulation of nerve signals by the electrical stimulator can check the conduction of the central nervous system and peripheral nerves and determine the location of nerve damage.

[0064] like Figure 8 Figure 2 shows a schematic diagram of measuring nerve conduction using a sticky, controllable hydrogel electrode clamp for intraoperative nerve potential monitoring. Electromyographic evoked potential stimulators 801 are used to inject a ~4.7 Hz, ~10 mA electrical stimulation current 802 at both ends of the electrode clamp, and an evoked potential signal is obtained at the nerve collection point 803 at the other end. The speed of nerve conduction can be obtained by comparing the distance and time between the two ends with conventional values ​​to determine whether the nerve is damaged.

[0065] The present invention utilizes a clamped nerve during surgery to capture the most pristine abnormal neural potential signals. All components can be sterilized and are made from a mixture of rigid and flexible materials. The electrode probe 102, clamp arm 103, and handpiece 105 are made of rigid materials, meeting the requirements of large-scale mass production. The surface hydrogel provides protection for the nerve, and the viscosity can be adjusted to achieve high-quality signal acquisition and on-demand detachment at the interface, ensuring safety and effectiveness. The system utilizes an ergonomic design, making it easier for the operator to maintain a firm grip on the instrument, thus eliminating unnecessary signal interference from external factors. The highly integrated back-end signal processing system 107 and data connection cable 106 can be welded to form a stable electrical connection, ensuring reliable data transmission. The electrode clamp features high fidelity, a wide linear range, and low artifacts. The highly integrated board transmits signals to a host computer system 108 for display via reliable commercially available transmission protocols such as Bluetooth, Wi-Fi, and USB. This ensures that the surgeon can observe the clamped nerve signal in real time, helping them determine the success of the surgery and analyze abnormal nerve discharges in real time. The present invention can collect abnormal data in a timely manner, give an alarm prompt, and inform the surgeon simultaneously, avoiding surgical failure due to the presence of abnormal potential signals after suturing in neurosurgery. It also helps patients evaluate their prognosis and provides a monitoring method to improve the success rate of surgery and avoid secondary surgery for patients. It has far-reaching significance in protecting patients undergoing neurosurgery.

[0066] 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 in the scope of protection of the present invention.

Claims

1. A viscous and controllable hydrogel electrode clip for intraoperative nerve potential monitoring, characterized in that: include: Handheld part; Two clamping arms, each of the clamping arms comprising a fixed end and a clamping end, the fixed ends of the two clamping arms being fixedly connected to the handheld portion respectively, and the clamping ends being arranged opposite to each other; Two electrode probes corresponding to the two clamping arms one by one, the tail of each electrode probe being connected to the clamping end of its corresponding clamping arm; Probe covers corresponding to the two electrode probes, each probe cover being mounted on and in contact with the corresponding electrode probe. The two electrode probes covered with the probe covers are used to clamp nerves during surgery and measure nerve potentials. The probe covers are made of a temperature-sensitive conductive hydrogel, which has different viscosities above and below the phase transition temperature. The fluid injection component is used to inject fluids of different temperatures into the interface where the probe cover contacts the nerve, thereby regulating the temperature of the probe cover and then regulating its viscosity to achieve close fit and lossless separation between the probe cover and the nerve.

2. The adhesively controllable hydrogel electrode clip for intraoperative nerve potential monitoring according to claim 1, characterized in that: The fluid injection assembly includes two fluid pipes arranged on the two clamping arms along the length direction, the outlet ends of the fluid pipes are respectively located above the corresponding probe covers, and the inlet ends of the fluid pipes are used to inject fluids of different temperatures.

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

4. The adhesively controllable hydrogel electrode clip for intraoperative nerve potential monitoring according to claim 3, characterized in that: The amide monomer is N- vinyl caprolactam, acrylamide or N-isopropyl acrylamide in one or more; The zwitterionic monomer is 2-methacryloyloxyethyl phosphorylcholine or sulfobetaine methacrylate; The conductive filler is any one or more of PEDOT:PSS, polypyrrole, polyaniline and derivatives thereof.

5. The adhesively controllable hydrogel electrode clip for intraoperative nerve potential monitoring according to claim 3, characterized in that: The temperature-sensitive conductive hydrogel further includes a cross-linking agent and an initiator for achieving chemical cross-linking of amide monomers.

6. The adhesively controllable hydrogel electrode clip for intraoperative nerve potential monitoring according to claim 5, characterized in that: In the temperature-sensitive conductive hydrogel, the mass fractions of the amide monomer, the zwitterionic monomer, the chitosan-gallic acid, the conductive filler, the initiator, and the cross-linking 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.

7. The adhesively controllable 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 side in contact with the nerve is an arc surface. The head is a semicircular head or a spherical head. The distance between the tails of the two electrode probes covered with the probe cover is smaller than the nerve diameter, and the distance between the heads is larger than the nerve diameter.

8. The adhesively controllable hydrogel electrode clip for intraoperative nerve potential monitoring according to any one of claims 1 to 7, characterized in that: It also includes back-end signal processing system and host computer system; The back-end signal processing system is electrically connected to the electrode probe via a data connection line provided in the clamping arm to receive the nerve potential signal, and transmits the signal to the host computer system via wireless or wired transmission after analyzing and processing the signal.

9. The adhesively controllable hydrogel electrode clip for intraoperative nerve potential monitoring according to claim 8, 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 powers the viscosity-regulating hydrogel electrode clamp 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 signal collected by the electrode probe and transmit it to the core processing module. The core processing module is used to process the signal transmitted by the potential acquisition front-end module and send it to the host computer system.

10. The adhesively controllable hydrogel electrode clip for intraoperative nerve potential monitoring according to claim 8, 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 to distinguish between abnormal nerve potential signals and normal nerve potential signals, and to score, map and bind them with the patient's prognosis to realize the intraoperative judgment of the nerve potential, and provide the functions of adding, deleting, modifying, checking, storing and exporting patient information.

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