A high-throughput deep brain electrode commissioning, sterilization and intraoperative access device

Abstract

The application belongs to the technical field of electrophysiological detection, and relates to a high-throughput deep cortex electrode debugging, sterilization and intraoperative use device.The device comprises a transparent hole shell, a silica gel separation plate with a clamping groove and an ethylene oxide compatible hub module.Test results show that the transparent hole shell and the silica gel separation plate with the clamping groove completely fix the electrode, and can avoid the tip of the electrode from being accidentally touched with the shell or other parts during the whole process of debugging, transportation, sterilization or use.The device can directly perform ethylene oxide sterilization on the connection of each module of the electrode without opening the shell, and obviously saves the time for assembling the electrode modules and debugging during the operation.Using the ethylene oxide compatible hub module can quickly release the data line during the operation, and the data line is mechanically protected and electromagnetically shielded, and is suitable for the complex electromagnetic environment and mechanical environment in the operating room.

Description

Technical Field

[0001] This invention belongs to the field of electrophysiological detection technology, and relates to an electrode adjustment, sterilization and intraoperative collection device, particularly a device for preoperative adjustment, ethylene oxide sterilization and intraoperative collection of a high-throughput single neuron probe in human craniotomy. Background Technology

[0002] Existing technologies have revealed that the rise of high-throughput deep cortical electrode (DCE) technology will significantly advance the spatial resolution of electrophysiological recordings. However, practical experience shows that this technology places extremely high demands on electrode implantation, especially during intraoperative implantation in human patients. Due to their extremely small cross-section (tens of micrometers), DCE electrodes are very fragile against lateral shear forces, and even slight mishandling during sterilization can lead to accidental contact and damage. Furthermore, the auxiliary components of DCE electrodes (including preamplifiers, analog-to-digital converters, and output leads) are typically small in size and complex in shape, making them difficult to secure. If placed in a standard surgical instrument case, slippage and collisions during sterilization and transport can also damage these components. Moreover, repeated loading and unloading are often required for equipment adjustments. Therefore, practical experience demonstrates an urgent need for a dedicated sterilization and intraoperative retrieval device for DCE electrodes.

[0003] Currently reported high-throughput deep cortical electrode sterilization devices use latex columns. The electrodes are held in place within the gaps between the latex columns using the elasticity of the latex columns, but this is not completely fixed, leaving the possibility of accidental damage from contact with the latex columns, the bottom of the latex column box, or the lid. Furthermore, the space inside the latex column box is relatively small, making placement and removal difficult. Electrodes, amplifiers, connecting wires, and clamps must be sterilized separately, and after sterilization, they must be assembled and tested in a sterile area during surgery. This poses a risk of poor contact and difficulty in adjustment, potentially prolonging the surgical procedure.

[0004] Based on the current state of the technology, the inventors of this application intend to provide an electrode adjustment, sterilization and intraoperative retrieval device, especially a device for preoperative adjustment, ethylene oxide sterilization and intraoperative retrieval of a high-throughput single neuron probe in human craniotomy. Summary of the Invention

[0005] The technical problem this invention aims to solve is to provide a novel high-throughput deep cortical electrode sterilization device for human craniotomy, based on the current state of existing technology. Specifically, it relates to a device for electrode adjustment, sterilization, and intraoperative retrieval, particularly a device for preoperative adjustment, ethylene oxide sterilization, and intraoperative retrieval of a high-throughput single-neuron probe during human craniotomy. This device is suitable for preparing for the implantation of high-throughput deep cortical electrodes during neurosurgery, achieving both effective sterilization and electrode protection while ensuring ease of operation.

[0006] To address the aforementioned technical problems, this application provides a high-throughput deep cortical electrode device. This device includes a transparent perforated housing, silicone separators with slots, and an ethylene oxide-compatible wiring module. In this device, the transparent perforated housing facilitates the complete entry of ethylene oxide into the sterilization zone and allows for easy observation of the ethylene oxide indicator strip's color change. The housing contains two silicone separators, each with two circular slots for securing the wiring harness and electrodes, and dividing the housing into three sections. This prevents parts from other sections from accidentally entering the electrode section, thus avoiding electrode damage. After the electrodes, electrode holders, preamplifier, and connecting wires are assembled, the battery holder can be inserted into the corresponding slots of the two separators for fixation. The electrode tip is located in a relatively open area within the housing, avoiding any possible contact with the surrounding environment. This facilitates complete ethylene oxide sterilization and also prevents accidental contact during transportation or handling that could damage the electrode. The ethylene oxide-compatible data cable module consists of a segmented protective mesh sleeve, a data cable strap, an ethylene oxide sterilization indicator strip, and an external adhesive tape fixing strap. Ensuring thorough sterilization, it is used for rapid release and retrieval of the data cable during surgery, preventing tangling or damage from the surgical microscope moving and crushing the cable. The shorter segmented protective mesh sleeve at the end is secured to the top cover of the housing with an external adhesive tape strap, facilitating adjustments without opening the housing.

[0007] The device applied for underwent a safety test: the results showed that, when using this device, no damage or misuse occurred to the electrodes during adjustment, sterilization, transfer, and intraoperative retrieval, demonstrating superior safety compared to traditional sterilization devices (latex cartridges). In a four-time ethylene oxide sterilization test using a traditional device, the electrodes experienced one displacement and one damage during sterilization and transfer.

[0008] The device in this application underwent a convenience test: the device sterilized and packaged using traditional methods was used three times during surgery, including three steps: intraoperative retrieval, suture handling, and connection and adjustment, which took 8-12 minutes; the device used was used three times during surgery, which took 3-4 minutes. Using this device can save 5-10 minutes of time, shorten the operation time, and reduce the difficulty of operation.

[0009] The device applied for underwent sterilization safety testing: Six ethylene oxide sterilization tests were performed using this device, while four tests were performed using a conventional device; the test strips indicated thorough sterilization in all cases. Bacterial cultures taken from the electrode base brush after ethylene oxide sterilization using both devices, in ordinary broth culture, all showed a concentration of ≤0 CFU / cm³. 2 This indicates that the disinfection effect of this device meets the standard and is no worse than that of traditional methods.

[0010] The device for adjusting, sterilizing, and retrieving deep cortical electrodes provided in this application includes a transparent perforated housing, a silicone partition with slots, and an ethylene oxide-compatible hub module. Test results show that, unlike existing technologies, the transparent perforated housing and silicone partition with slots in this application completely fix the electrodes, preventing accidental contact between the electrode tips and the housing or other parts during adjustment, transportation, sterilization, or retrieval. This device allows for direct ethylene oxide sterilization of the entire module without opening the housing, significantly saving time during intraoperative assembly and adjustment of the electrode modules. The ethylene oxide-compatible hub module allows for rapid intraoperative release of the data cable and provides mechanical protection and electromagnetic shielding for the data cable, making it suitable for the complex electromagnetic and mechanical environments of operating rooms. Attached Figure Description

[0011] To more clearly illustrate the technical solutions in this application, the accompanying drawings required in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort. Wherein:

[0012] Figure 1 This is a schematic diagram of the structure of each part of the high-throughput deep cortical electrode adjustment, sterilization and intraoperative retrieval device of this application and the composition of the deep cortical electrode elements;

[0013] Figure 2 This is a flowchart illustrating the specific implementation method of the high-throughput deep cortical electrode adjustment, sterilization, and intraoperative retrieval in this application. Detailed Implementation

[0014] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.

[0015] Example 1

[0016] Please see Figure 1 , Figure 1This is a schematic diagram of the structure of the various parts of the high-throughput deep cortical electrode adjustment, sterilization, and intraoperative retrieval device of this application, and the composition of the deep cortical electrode elements. The tissue preservation and transport device includes: a transparent porous shell 1 made of SSPE material, shown as a bottom 1.1 and a cover 1.2 (the shell 1 is divided into three sections by two silicone partitions 2 with arthroscopic endoscope slots to form a shield around it). The assembled electrode elements, including probes 0.1, electrode support rods 0.2, preamplifiers 0.3, and data cables 0.4, are placed in the slots. The data cable is housed in an ethylene oxide-compatible hub module 3, which includes a segmented protective mesh sleeve (copper mesh plated with silver) 3.1, a hub strap made of 2mm thick aluminum foil 3.2, an ethylene oxide sterilized indicator strip 3.3, and an external adhesive tape fixing strap 3.4.

[0017] Step S201: Assembly: Assemble the electrode, preamplifier, electrode holder, and data cable into a single unit and insert it into one of the slots. Wrap the electrode and data cable with a segmented protective mesh sleeve, and then store them together with the cable tie and ethylene oxide test paper before inserting them into the other slot.

[0018] Step S202: Debugging: Close the cover, connect the data cable to the computer through the groove between the cover and the housing, and check the probe connection. If there is an indicator light on the electrode, you can also observe the indicator light of the preamplifier through the transparent housing. After debugging, use external tape to fix the end of the data cable to the cover.

[0019] Step S203: Sterilization: After the shell is wrapped in a transparent bag, it is treated at 49.0°C and 60% relative humidity, with a vacuum setpoint of 1.3 psia and a humidity setpoint of 2.3 psia for 30 minutes, and a vacuum pressurization rate of 25 psia / min. Next, in the EO exposure phase, 100% ethylene oxide is used at a gas concentration of 600 mg / L, the temperature is maintained at 49.0°C, the sterilizing agent setpoint is 7.6 psia, the exposure time is 120 minutes, and the vacuum pressurization rate is also 25 psia / min. After confirming a color change in the ethylene oxide test strip, it is ventilated at ambient temperature for 23 hours and 23 minutes.

[0020] Step S204: Retrieval: During the procedure, the surgeon removes the external adhesive tape, opens the cover, presses the end of the electrode holder to tilt the electrode tip upwards, and then removes the electrode element. Remove the data cable harness, tear off the cable tie, and the data cable can be quickly released.

[0021] Test results show that the transparent perforated shell and the silicone separator with slots of this device completely fix the electrodes, preventing accidental contact between the electrode tips and the shell or other parts during debugging, transportation, sterilization, or handling. This device allows for direct ethylene oxide sterilization of the entire module without opening the shell, significantly saving time during intraoperative assembly and debugging of electrode modules. Using an ethylene oxide-compatible hub module allows for rapid release of data cables during surgery, while also providing mechanical protection and electromagnetic shielding, making it suitable for the complex electromagnetic and mechanical environments of operating rooms.

[0022] The above description is merely an embodiment of this application and does not limit the patent scope of this application. Any equivalent structural or procedural transformations made using the content of this application's specification and drawings, or direct or indirect applications in other related technical fields, are similarly included within the patent protection scope of this application.

Claims

1. A high-throughput deep cortical electrode adjustment, sterilization, and intraoperative retrieval device, characterized in that, The device includes a transparent perforated housing (1), a silicone partition plate with slots (2), and an ethylene oxide-compatible hub module (3). The housing has two built-in silicone partitions, each with two circular slots for fixing the wiring harness and electrodes, and dividing the housing into three sections. After the electrodes, electrode holders, preamplifiers, and connecting wires are assembled, the battery holders are inserted into the corresponding slots of the two partitions for fixation. The electrode tips are located in a relatively open position in the housing to avoid any possible contact with the surrounding area. The ethylene oxide compatible wiring module consists of a segmented protective mesh sleeve, wiring straps, ethylene oxide sterilization indicator strips, and external adhesive tape fixing straps. The segmented protective mesh sleeve at the end is shorter and is fixed to the top cover of the housing by the external adhesive tape fixing straps, which facilitates debugging without opening the housing.

2. The high-throughput deep cortical electrode adjustment, sterilization, and intraoperative retrieval device according to claim 1, characterized in that, The transparent porous shell (1) consists of a bottom (1.1) and a cover (1.2). The shell (1) is divided into three sections by two silicone partitions (2) with arthroscopic endoscope slots.

3. The high-throughput deep cortical electrode adjustment, sterilization, and intraoperative retrieval device according to claim 1, characterized in that, The assembled electrode components, including probes (0.1), electrode support rods (0.2), preamplifiers (0.3), and data cables (0.4), are placed in the slot of the silicone partition plate (2).

4. The high-throughput deep cortical electrode adjustment, sterilization, and intraoperative retrieval device according to claim 1, characterized in that, The ethylene oxide compatible hub module (3) consists of a segmented protective mesh sleeve, a hub belt, an ethylene oxide sterilization indicator strip, and an external adhesive tape fixing belt.

Images