A high-flux deep brain electrode implantation device and electrode reinforcement method

Abstract

The application belongs to the technical field of electrophysiological detection, and relates to an intraoperative electrode implanting device and a reinforcing method thereof. The application provides an intraoperative implanting device for high-throughput deep cortex electrode, which comprises a puncture universal arm, a puncture universal arm adapter, a micrometer sliding table, an electrode holder fastening device and a front probe protection-electromagnetic shielding two-in-one element. The reinforcing method for the high-throughput deep cortex electrode comprises the steps of hanging, dispensing, fine adjustment and fixing. The test and use results show that the Neuropixels1.0 high-throughput cortex electrode reinforced by the reinforcing method can complete cortex implanting without breakage in the implanting process. The method can effectively overcome the defect that breakage occurs in the implanting process of the prior art. The method can meet the requirements of aseptic operation, safety and convenience in the whole implanting process.

Description

Technical Field

[0001] This invention belongs to the field of electrophysiological detection technology, and relates to clinical neurophysiological recording technology, and in particular to a high-throughput single neuron probe reinforcement method for intracranial surgery recording. Background Technology

[0002] The rise of high-throughput deep cortical electrode technology will propel the spatial resolution of electrophysiological recordings to a new level. However, this technology places extremely high demands on electrode implantation, especially during intraoperative implantation in human patients. Unlike surface cortical electrodes (ECoG), which only involve attachment of electrodes above the pia mater, or stereotactic electroencephalography (SEEG), which has strong rigidity and deep insertion depth (generally several centimeters below the cortex), high-throughput deep cortical electrodes, due to their extremely small cross-section (tens of micrometers), are very vulnerable to lateral stress. They require insertion and fixation at a specific depth (generally only 2-8 mm) within the cortex under highly collimated conditions after piatomy for signal acquisition. Furthermore, unlike implantation devices in small animals (such as rodents), intraoperative implantation devices in human patients must be easy to sterilize, compatible with other surgical instruments and navigation devices, easy to install and remove, and not obstruct the surgical field of view.

[0003] Currently used high-throughput deep cortical electrode implantation devices are modified from animal experimental three-dimensional stereotactic positioning equipment, designed for rodents. They employ multiple sets of stereotactic guide rails to provide implantation freedom, resulting in a large and complex overall structure that is difficult to implement using traditional aseptic surgical methods. Furthermore, they require fixation on a specialized vibration-damping experimental table, making them incompatible with the operating room environment. In addition, the device's operating space and field of view are very limited, making it impossible to perform pia mater dissections or handle potential complications such as intraoperative bleeding. Moreover, the electrode implantation range is determined by mouse brain atlases, and the spatial freedom cannot meet the requirements for intraoperative implantation in the human brain. According to literature, the rise of high-throughput deep cortical electrode technology will push the spatial resolution of in vivo electrophysiological recording to a new level, but the related technology places extremely high demands on electrode implantation, especially during intraoperative implantation in human patients. Research has confirmed that, unlike small animals (such as rodents), the human brain is exceptionally developed, covered by a relatively tough pia mater, and the brain surface has considerable mobility due to respiration and vascular fluctuations. High-throughput deep cortical electrodes are typically made of silicon, which has poor ductility and high brittleness. Literature reports that they are prone to breakage when subjected to lateral shear forces (such as penetrating the pia mater or when there is high brain surface mobility) (especially microelectrodes with a cross-sectional thickness of <100μm). However, increasing the cross-section of the electrode implantation portion during electrode fabrication to improve stress resistance would increase the risk of injury and surgery.

[0004] Based on the current state of the technology, the inventors of this application intend to provide a high-throughput deep cortical electrode intraoperative implantation device and electrode reinforcement method, especially for high-throughput deep cortical electrode intraoperative reinforcement method. The method of the present invention can improve the electrode's tolerance to transverse shear force without increasing the cross-sectional area of ​​the electrode implantation part. Summary of the Invention

[0005] The purpose of this invention is to provide a high-throughput deep cortical electrode intraoperative implantation device and electrode reinforcement method, based on the current state of the technology, particularly for the intraoperative reinforcement of high-throughput deep cortical electrodes. This invention provides a novel high-throughput deep cortical electrode implantation device for human craniotomy, used for the implantation of high-throughput deep cortical electrodes during neurosurgery, meeting the requirements of aseptic operation, safety, and convenience throughout the implantation process.

[0006] Specifically,

[0007] This invention provides a high-throughput deep cortical electrode intraoperative implantation device, the device comprising a puncture universal arm, a puncture universal arm adapter, a micrometer slide, an electrode holder locking device, and a front probe protection-electromagnetic shielding dual-function element.

[0008] The universal arm adapter includes: a slide rail matching plate, a universal arm connecting column, and a alignment groove; the slide rail matching plate is fixedly connected to the slide rail side of the micrometer slide table, the universal arm connecting column is set on the back of the micro-operation bracket, the universal arm connecting column is connected to the sleeve of the puncture universal arm, and the universal arm connecting column has an alignment groove.

[0009] The micrometer slide includes: a micrometer advance head, a slide side, and a slide rail side; the slide side is connected to the electrode holder locking device, and the slide rail side is connected to the universal arm adapter.

[0010] The electrode clamping device for electrode implantation includes: a slide matching plate, a triangular locking groove, and a clamping element; the triangular locking groove matches the triangular locking groove on the clamping element, and the clamping element is fixedly connected to the slide matching plate.

[0011] The pre-probe protection-electromagnetic shielding dual-function component is fixed at a high or low position on the support rod, including: an electrode support rod sleeve, a hand-tightening set bolt hole, and a shielding and protection frame; the electrode support rod sleeve is adapted to the electrode support rod, and the electrode support rod sleeve has a hand-tightening set bolt hole, and the shielding and protection frame is connected to the lower end of the electrode support rod sleeve.

[0012] Ideally, the slide rail matching plate of the universal arm adapter and the slide rail side of the micrometer slide, the clamping element in the electrode holder of the electrode implantation device and the slide matching plate, and the electrode support rod sleeve in the pre-probe protection-electromagnetic shielding dual-function component are all screwed together.

[0013] Ideally, the screws connecting the slide rail matching plate to the slide rail side of the micrometer slide table are stainless steel screws.

[0014] Ideally, in the electrode clamping device of the electrode implantation apparatus, the clamping element and the slide matching plate are connected by bolts and hand-tightened nuts.

[0015] In a better integrated component for front probe protection and electromagnetic shielding, the electrode support rod sleeve and the electrode support rod are connected by the threaded hole of the hand-tightening set bolt on the electrode support rod sleeve.

[0016] A better approach is to include a perforated, moist gauze pad in the pre-probe protection-electromagnetic shielding combination element, which abuts against the shielding and protective frame. This not only keeps the brain surface moist during surgery, reducing potential damage, but also helps lower the risk of infection.

[0017] Ideally, the shielding and protection frame should be covered with a copper mesh.

[0018] Preferably, the kit includes the aforementioned high-throughput deep cortical electrode intraoperative implantation device. Through the assembly and use of the various components of the high-throughput deep cortical electrode intraoperative implantation device, aseptic operation throughout the surgical procedure can be achieved. Based on this, the risk of infection can be reduced and the safety of the surgical procedure can be improved.

[0019] The method of using the high-throughput deep cortical electrode intraoperative implantation device of the present invention is as follows:

[0020] Step S501: Before sterilization, connect the high-throughput cortical electrode to the matching electrode holder, and place the pre-probe protection-electromagnetic shielding dual-module in the low position so that the electrode is completely located in the shielding and protection frame. Then, lock the knob by turning it to fix the module in the low position, which protects the electrode. Fix the puncture universal arm adapter, micrometer slide, and electrode holder locking module together with stainless steel screws. Sterilize together with the perforated gauze for later use.

[0021] Step S502: During the surgery, fix the puncture universal arm to the head frame, insert the universal arm connecting post of the puncture universal arm adapter into the universal arm sleeve, so that the collimation groove is aligned with the guide post of the universal arm sleeve, and lock the set screw on the universal arm sleeve; loosen the set nut of the electrode holder fastening device, put the upper part of the electrode holder into the triangular locking groove, and then lock the set nut; loosen the hand-tightened set screw on the pre-probe protection-electromagnetic shielding two-in-one module, place the module in a high position, and tighten it after fully exposing the electrode; after completing the pia mater dissection, align the holes of the perforated wet gauze with the area to be implanted and lay it on the brain surface;

[0022] Step S503: During implantation, adjust the universal arm so that the electrode is aligned with the hole in the perforated wet gauze. Rotate the micrometer of the slide to allow the electrode to enter the dermis. Loosen the hand-tightening screw on the pre-probe protection-electromagnetic shielding dual-function module, place the module in the low position, press down the perforated wet gauze, and complete the implantation.

[0023] The electrode implantation device provided by this invention includes a universal arm adapter for puncture, a micrometer for micromanipulation, an electrode holder and locking device, a combined front probe protection and electromagnetic shielding device, and perforated gauze. The universal arm adapter, while ensuring alignment accuracy and implantation freedom, replaces the three-dimensional directional guide rail, miniaturizing the device, fully exposing the surgical field and visual field, and facilitating sterilization. The electrode holder and locking device is compatible with various types of electrode support rods, facilitating intraoperative loading and unloading. The combined front probe protection and electromagnetic shielding module not only prevents accidental electrode contact and damage during transport but also provides electromagnetic shielding and fixation of the brain surface during surgery, improving signal quality. The perforated moist gauze helps maintain brain surface moisture during surgery, reducing potential damage.

[0024] The method of this invention consists of four steps: suspension, dispensing, fine-tuning, and fixing. Suspension refers to loading a photocurable polymer gel medium into a specially designed injection device, keeping the injection head of the device suspended, and injecting an appropriate amount of the photocurable polymer gel medium, causing the medium to suspend on the injection head and form a droplet. Dispensing refers to using the injection head to carry the droplet close to the electrode base, and quickly removing the injection head once the droplet adheres to the interface between the electrode base and the substrate. Fine-tuning refers to gently pushing the droplet with a thin nylon thread, causing part of the droplet to suspend above the electrode base, where it wraps around the electrode base under gravity. Fixing refers to using a curing electromagnetic wave generator with a specific wavelength range to generate curing electromagnetic waves, which act on the gel medium droplet wrapping the electrode base, causing the curing components in the medium to cross-link and achieve curing.

[0025] The present invention was tested and used to perform cortical implantation on two human patients and one Labrador Retriever using the Neuropixels 1.0 high-throughput cortical electrode reinforced by the present reinforcement method. The results showed that no breakage occurred during the implantation process, while related literature reported that 3 out of 7 patients experienced breakage during implantation.

[0026] The beneficial effects of this invention are as follows: The Neuropixels 1.0 high-throughput cortical electrodes reinforced by this method underwent cortical implantation without any breakage during the implantation process. This effectively overcomes the defect of breakage during implantation in existing technologies. Furthermore, it meets the requirements for aseptic operation, safety, and convenience throughout the implantation process. Attached Figure Description

[0027] To more clearly illustrate the technical solution of the present invention, the drawings used in the embodiments will be briefly introduced below. Obviously, each drawing described below is for a part of the embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0028] Figure 1 This is a schematic diagram of the universal arm adapter for puncture of the high-throughput deep cortical electrode implantation device of the present invention.

[0029] Figure 2 This is a schematic diagram of the micrometer micromanipulation structure of the high-throughput deep cortical electrode implantation device of the present invention.

[0030] Figure 3 This is a schematic diagram of the electrode holder and fastening device structure of the high-throughput deep cortical electrode implantation device of the present invention.

[0031] Figure 4 This is a schematic diagram of the pre-probe protection-electromagnetic shielding dual-module of the high-throughput deep cortical electrode implantation device of the present invention.

[0032] Figure 5 This is a flowchart illustrating a high-throughput deep cortical electrode reinforcement method.

[0033] Figure 6 This is a flowchart illustrating a specific implementation of the high-throughput deep cortical electrode implantation device of the present invention.

[0034] The accompanying drawings are described below:

[0035] 11 - Micro-operation bracket, 12 - Universal arm connecting column, 13 - Collimation groove;

[0036] 21 - Micrometer feed head; 22 - Slide side; 23 - Slide rail side;

[0037] 31 - Slide matching plate, 32 - Triangular locking through groove, 33 - Locking element;

[0038] 41 - Electrode support rod sleeve; 42 - Hand-tightened set bolt thread hole; 43 - Shielding and protection frame. Detailed Implementation

[0039] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0040] Example 1

[0041] The high-throughput deep cortical electrode device of the present invention includes a puncture universal arm, a puncture universal arm adapter, a micrometer micromanipulation device, an electrode holder locking device, a front probe protection-electromagnetic shielding dual device, and perforated gauze.

[0042] like Figure 1 As shown, the adapter of the present invention includes: a slide rail matching plate 31, which is connected to the slide rail side of the micrometer slide table by stainless steel screws; a universal arm connecting post 12 on the back of the micro-operation bracket 11, which is used to connect to the sleeve of the puncture universal arm; the universal arm connecting post 12 has a alignment groove 13, which can match the guide post on the inner surface of the puncture universal arm sleeve to ensure that the device is aligned and to prevent slippage in the event of tightening failure.

[0043] like Figure 2 As shown, the slide in this invention includes: a micrometer advance head 21, a slide side 22 connected to an electrode holder clamping device, and a slide rail side 23 connected to a universal arm adapter, which can achieve submicron level implantation depth control.

[0044] like Figure 3 As shown, the fastening device in this invention includes: a slide matching plate 31, which is connected to the slide side of the micrometer slide by stainless steel screws; a triangular locking groove 32 that matches the triangular locking groove on the fastening element 33, which is suitable for electrode support rods of various lengths, cross-sectional shapes and sizes, while ensuring alignment accuracy; and a fastening element 33 that is connected to the slide matching plate by bolts and hand-tightened nuts, which enables convenient loading and unloading during surgery.

[0045] like Figure 4 As shown, in the electrode implantation device of this invention, the pre-probe protection-electromagnetic shielding integrated module includes: an electrode support rod sleeve 41, adaptable to various sizes of electrode support rods; the electrode support rod sleeve 41 has hand-tightening screw holes 42 for fixing the component at the high and low positions of the support rod; and a shielding and protection frame 43 connected to the lower end of the electrode support rod sleeve 41 to achieve electrode protection and electromagnetic shielding (a copper mesh can be used as a cover if necessary). This part also holds the porous wet gauze, helping to keep the brain tissue moist during surgery and reduce interference from brain surface activity on electrode recording.

[0046] like Figure 5 As shown, the high-throughput deep cortical electrode reinforcement method of the present invention includes the following steps:

[0047] Suspension: The high-polymer light-curing gel medium is loaded into a special injection device. The injection head of the medium injection device is kept suspended in the air, and an appropriate amount of high-polymer light-curing gel medium is injected, so that the medium is suspended on the injection head and forms droplets.

[0048] Dispensing: Use the injection head to carry the droplet close to the base of the electrode, and quickly remove the injection head once the droplet adheres to the base of the electrode.

[0049] Fine-tuning: Use a thin nylon thread to gently push the droplet, causing part of the droplet to suspend at the base of the electrode, and then wrap around the base of the electrode under the action of gravity.

[0050] Fixation: A curing electromagnetic wave generator with a specific wavelength range is used to generate curing electromagnetic waves, which act on the medium droplets surrounding the electrode base to cure the medium.

[0051] Using a puncture universal arm instead of a three-dimensional directional guide rail exposes a wider surgical field while maintaining freedom of movement. The collimation groove of the universal arm adapter ensures extremely high overall collimation accuracy of the implanted device, while preventing slippage due to accidental loosening of the set screws. The universal arm adapter connects to a micrometer for micro-manipulation, enabling sub-micron level implantation accuracy of the electrodes within the dermis. The electrode clamping and tightening device, with its double-sided triangular locking through-slot design, is compatible with electrode support rods of various lengths, cross-sectional shapes, and sizes, while maintaining collimation accuracy. A hand-tightened nut is used for tightening, facilitating intraoperative loading and unloading. The pre-probe protection-electromagnetic shielding dual-function component can be adjusted to a low position by hand-tightening the set screw before operation to prevent accidental electrode contact and damage during handling. It can be adjusted to a high position during implantation and lowered back to a low position after implantation. The copper mesh covering its front end protects the analog circuitry below the ADC module from external electromagnetic interference. A perforated, moist gauze pad covers the brain surface, exposing only the implantation site. This helps maintain brain tissue moisture during surgery, while the pre-mounted probe protects the gauze with an electromagnetic shielding module, reducing interference from brain surface activity on electrode recording. The device structure (except for the perforated, moist gauze pad) consists entirely of aluminum alloy and stainless steel components, making it lightweight and resistant to common surgical instrument sterilization methods such as autoclaving.

[0052] In the description of this invention, the terms "comprising," "including," or any other variations thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising a reference structure" does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element. It should be noted that, herein, relational terms such as "first," "second," etc., are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations.

[0053] The embodiments described above are merely specific implementations of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be conceived by those skilled in the art within the scope of the technology disclosed in the present invention without creative effort should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of protection of the claims in the present invention.

Claims

1. A high-throughput deep cortical electrode intraoperative implantation device, characterized in that, The device includes a puncture universal arm, a puncture universal arm adapter, a micrometer slide, an electrode holder locking device, and a front probe protection-electromagnetic shielding dual-function component; wherein... The universal arm adapter includes: a slide rail matching plate, a universal arm connecting column, and a alignment groove; the slide rail matching plate is fixedly connected to the slide rail side of the micrometer slide table, the universal arm connecting column is set on the back of the micro-operation bracket, the universal arm connecting column is connected to the sleeve of the puncture universal arm, and the universal arm connecting column has an alignment groove. The micrometer slide includes: a micrometer advance head, a slide side, and a slide rail side; the slide side is connected to the electrode holder locking device, and the slide rail side is connected to the universal arm adapter. The electrode clamping device for electrode implantation includes: a slide matching plate, a triangular locking groove, and a clamping element; the triangular locking groove matches the triangular locking groove on the clamping element, and the clamping element is fixedly connected to the slide matching plate. The front probe protection-electromagnetic shielding dual-function component is fixed at the high or low position of the support rod, including: electrode support rod sleeve, hand-tightening set bolt holes, and shielding and protection frame; the electrode support rod sleeve is adapted to the electrode support rod, the electrode support rod sleeve has hand-tightening set bolt holes, and the shielding and protection frame is connected to the lower end of the electrode support rod sleeve; During the procedure, the puncture universal arm is fixed to the head frame, and the universal arm connecting post of the puncture universal arm adapter is placed into the universal arm sleeve, so that the collimation groove is aligned with the guide post of the universal arm sleeve. The upper part of the electrode clamp is placed into the triangular locking groove, and the pre-probe protection-electromagnetic shielding dual-module is placed in the high position. After fully exposing the electrode, it is tightened. During implantation, the micrometer of the slide is rotated to allow the electrode to enter the dermis. The pre-probe protection-electromagnetic shielding dual-module is then placed in the low position to complete the implantation.

2. The high-throughput deep cortical electrode intraoperative implantation device according to claim 1, characterized in that, The slide rail matching plate of the universal arm adapter and the slide rail side of the micrometer slide table, the clamping element in the electrode holder of the electrode implantation device and the slide table matching plate, and the electrode support rod sleeve in the front probe protection-electromagnetic shielding dual-integrated element are all screwed together.

3. The high-throughput deep cortical electrode intraoperative implantation device according to claim 2, characterized in that, The screws connecting the slide rail matching plate to the slide rail side of the micrometer slide table are stainless steel screws.

4. The high-throughput deep cortical electrode intraoperative implantation device according to claim 2, characterized in that, In the electrode clamping device of the electrode implantation apparatus, the clamping element and the slide matching plate are connected by bolts and hand-tightened nuts.

5. The high-throughput deep cortical electrode intraoperative implantation device according to claim 2, characterized in that, In the aforementioned pre-probe protection-electromagnetic shielding dual-function component, the electrode support rod sleeve and the electrode support rod are connected through the threaded hole of the hand-tightening set bolt on the electrode support rod sleeve.

6. The high-throughput deep cortical electrode intraoperative implantation device according to claim 1, characterized in that, The aforementioned pre-probe protection-electromagnetic shielding dual-function element also includes a perforated wet gauze, which abuts against the shielding and protection frame.

7. The high-throughput deep cortical electrode intraoperative implantation device according to claim 1, characterized in that, The shielding and protection frame is covered with copper mesh.

8. A kit for intraoperative implantation of a deep cortical electrode, characterized in that, The kit includes the high-throughput deep cortical electrode intraoperative implantation device as described in claim 1.

9. A method for reinforcing high-throughput deep cortical electrodes, characterized in that, The following steps can be taken to improve the electrode's resistance to lateral shear forces without increasing the cross-sectional area of ​​the implanted portion: S101, load the polymer photocurable gel medium into the injection device, keep the injection head of the medium injection device suspended, inject an appropriate amount of polymer photocurable gel medium, so that the medium hangs on the injection head and forms droplets. S102, use the injection head to carry the droplet close to the electrode base, and quickly remove the injection head when the droplet adheres to the junction of the electrode base and the base. S103, fine adjustment refers to using a thin nylon thread to gently push the droplet, so that part of the droplet is suspended in the air to the base of the electrode, and wraps around the base of the electrode under the action of gravity; S104 uses a curing electromagnetic wave generator with a specific wavelength range to generate curing electromagnetic waves, which act on the gel-like medium droplets surrounding the electrode base, causing the curing components in the medium to cross-link and achieve curing.

10. The high-throughput deep cortical electrode reinforcement method according to claim 9, characterized in that, The injection device uses the high-throughput deep cortical electrode intraoperative implantation device as described in claim 1.

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