Intraoperative nerve continuous stimulation device

Abstract

The invention relates to an intraoperative nerve continuous stimulation device, comprising: a clamp main body, the clamp main body comprising a clamping arm capable of being opened and closed, the clamping arm being used for clamping a tested nerve; the clamping part of the clamping arm is provided with an electrode slice which can be attached to a tested nerve, an electrical connection assembly is arranged in the clamping arm, the clamping arm is connected with a cable, the electrical connection assembly is electrically connected between the electrode slice and the cable, and the cable is externally connected with a stimulation current generating device; and the clamping device further comprises penetrating through holes which are formed in the clamping arms and are used for the suture lines to pass through. According to the device, a doctor can be assisted in taking and placing the nerve electrical stimulation electrode in an operation, the nerve electrical stimulation electrode can be sutured and fixed on other tissues near a nerve, and nerve continuous stimulation monitoring can be stably and continuously performed in the operation.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an intraoperative nerve continuous stimulation device. BACKGROUND

[0002] Intraoperative nerve electrical stimulation monitoring is an indispensable technical means in modern surgery, and its core significance lies in real-time assessment of nerve function and maximum reduction of iatrogenic nerve damage, thereby improving surgical safety and patient prognosis quality.

[0003] Intraoperative nerve continuous stimulation monitoring is an advanced technology of traditional intraoperative nerve monitoring. Continuous nerve stimulation during surgery is an important nerve monitoring and positioning technology, mainly used to protect nerve function, confirm nerve anatomy or evaluate nerve conduction integrity. Through continuous and dynamic nerve electrical stimulation and real-time feedback, surgical safety is significantly improved, especially in high-risk nerve damage surgeries such as thyroid, skull base, spine and peripheral nerves.

[0004] The ring-shaped nerve electrode with publication number CN117297618A and CN105536141A has a certain flexibility, realizes nerve stimulation while protecting the nerve from damage, but it is an implantable design without a structure design to assist the surgeon in placing or removing the electrode during surgery, and cannot meet the demand of convenient electrode placement during surgery. SUMMARY

[0005] The purpose of the present application is to provide an intraoperative nerve continuous stimulation device that can assist the surgeon in placing and removing the nerve electrical stimulation electrode during surgery, and can suture and fix the nerve electrical stimulation electrode to other tissues near the nerve, so that continuous nerve stimulation monitoring can be stably and continuously performed during surgery.

[0006] To achieve the above purpose, the present application provides an intraoperative nerve continuous stimulation device, comprising: a clamp body, the clamp body comprising a clamping arm that can be opened and closed, the clamping arm being used to clamp the measured nerve; The clamping part of the clamping arm is provided with an electrode sheet capable of being attached to the measured nerve, and an electrical connection assembly is arranged inside the clamping arm, the clamping arm is connected with a cable, and the electrical connection assembly is electrically connected between the electrode sheet and the cable, and the cable is externally connected with a stimulating current generating device; It also includes a through hole on the clamping arm through which a suture line can pass, and the suture line is sutured to the tissue near the measured nerve, so as to fix the clamp body.

[0007] In an optional embodiment, the clamp body comprises a whole X-shaped silica gel clamp, the silica gel clamp comprises main clamping arms and auxiliary clamping arms with different lengths, and the ends of the main clamping arms and the auxiliary clamping arms are respectively provided with relatively occlusive clamps, and the clamps are respectively provided with clamping grooves to form clamping positions of the measured nerves.

[0008] In an optional embodiment, the clamping grooves comprise symmetrically arranged arc grooves, and the electrode pieces comprise symmetrically arranged arc metal pieces which are correspondingly attached to the groove surfaces of the arc grooves.

[0009] In an optional embodiment, the main clamping arms and the auxiliary clamping arms have the same width, and the electrode pieces are arranged in pairs between the main clamping arms and the auxiliary clamping arms.

[0010] In an optional embodiment, the electrical connection assembly comprises a flexible circuit board or a flexible wire which is encapsulated in the clamping arms.

[0011] In an optional embodiment, the electrode pieces comprise a single group, and the single group of the electrode pieces is arranged at the central position in the width direction of the clamping arms; the flexible circuit board comprises a pair of two pieces which are connected between the cable and the electrode pieces, or the flexible wire comprises a pair of two lines which are connected between the cable and the electrode pieces.

[0012] In an optional embodiment, the electrode pieces comprise multiple groups, and the multiple groups of the electrode pieces are arranged at intervals along the width direction of the clamping arms. The flexible circuit board comprises multiple pairs which are connected between the cable and the electrode pieces, or the flexible wire comprises multiple pairs which are connected between the cable and the electrode pieces, and the multiple pairs of the flexible wires are bundled in the cable.

[0013] In an optional embodiment, each group of the electrode pieces is independently controlled, the flexible circuit board or the flexible wire comprises multiple pairs of independent correspondences, and each group of the electrode pieces is correspondingly connected to the flexible circuit board or the flexible wire.

[0014] In an optional embodiment, the through holes comprise multiple through holes, and each of the multiple through holes comprises a through hole channel which is arranged through the clamping arms. The multiple through hole channels are arranged in parallel, or the multiple through hole channels are arranged in a square shape on the clamping arms. The suture passes through the through hole channel and is sutured to the surrounding tissue of the measured nerve.

[0015] In an optional embodiment, the silica gel clamp is made of medical-grade silica gel, and the surface of the clamps at the clamping positions is provided with anti-slip textures.

[0016] The adjustable clamping arms allow for clamping of the nerve being tested, ensuring stable and continuous stimulation monitoring.

[0017] By incorporating electrode pads at the clamping points of the clamping arm, the electrode pads can adhere to the nerve being measured, achieving stable and continuous neural electrode function.

[0018] By setting an electrical connection component inside the clamping arm, and connecting the clamping arm to the cable, the electrical connection component is electrically connected between the electrode pad and the cable, which can form a continuous electrical connection path, facilitating the conduction of stimulation current. Combined with connecting the cable to an external stimulation current generating device, the external stimulation current can be ultimately conducted to the electrode pad, thereby completing the construction of the main function of the intraoperative continuous nerve stimulation device.

[0019] In order to keep the main body of the clamp in a stable fixed state and free the operator's hands, through-holes are provided on the clamping arms for sutures to pass through. The sutures outside the through-holes can be sutured to the tissue near the nerve being tested, thereby fixing the main body of the clamp.

[0020] Furthermore, once the continuous nerve stimulation monitoring is completed, the clamp body can be released from its fixed state by removing the sutures at the additional site, allowing for convenient placement and removal of the continuous nerve stimulation device in a non-implantable installation manner.

[0021] Other features and advantages of this application will be described in detail in the following detailed description section. Attached Figure Description

[0022] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0023] Figure 1 This is a side view schematic diagram of the intraoperative continuous nerve stimulation device of this application; Figure 2 This is a schematic diagram of a single set of electrode sheets on the fixture body; Figure 3 This is a schematic diagram of the structure of multiple sets of electrode sheets on the fixture body.

[0024] icon: 1-Clamp body; 11-Clamping arm; 111-Main clamping arm; 112-Secondary clamping arm; 113-Pliers; 114-Clamping groove; 2-Electrode sheet; 3-Electrical connection components; 4-Cables; 5-Through-through hole. Detailed Implementation

[0025] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, 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. The components of the embodiments of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0026] In the description of this application, it should be noted that the terms "inner" and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product is in use. They are used only for the convenience of describing this application and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application. Furthermore, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0027] In the description of this application, it should also be noted that, unless otherwise expressly specified and limited, the terms "setup" and "connection" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0028] The intraoperative continuous nerve stimulation device in this application is mainly used for intraoperative continuous nerve stimulation monitoring. By improving the structural composition of the device body and setting necessary details, a continuous stimulation current path is formed, so that the electrode can contact the nerve being tested in a non-implantable clamping and release form. Furthermore, the device body can be detachably fixed to the tissue near the nerve being tested, thereby maintaining the device body in a fixed state during the operation.

[0029] See Figure 1- Figure 3 The intraoperative continuous nerve stimulation device in this application mainly includes a clamp body 1, electrode pads 2, electrical connection components 3, cables 4, and through holes 5.

[0030] The clamp body 1 serves as the main structure and includes a pair of openable clamping arms 11. The clamping arms 11 are used to clamp the nerve to be tested. Through the openable clamping arms 11, and combined with the electrode pads 2 that can fit with the nerve to be tested at the clamping part of the clamping arms 11, the nerve to be tested can be quickly clamped and released, which greatly facilitates the placement and removal of the stimulation electrode during the operation, and overcomes the irreversible installation disadvantage of existing implantable stimulation electrodes.

[0031] Electrode 2 is disposed at the clamping part of clamping arm 11, specifically by embedding or attaching to the clamping part. Electrical connection component 3 is disposed inside clamping arm 11. Cable 4 is connected to clamping arm 11. Electrical connection component 3 is electrically connected between electrode 2 and cable 4 to establish electrical connection between electrode 2 and external cable 4, so that cable 4, electrical connection component 3 and electrode 2 form a continuous current conduction path.

[0032] By connecting cable 4 to an external stimulation current generator (not shown in the figure), the stimulation current generated by the stimulation current generator can be conducted to electrode 2 for continuous and stable nerve stimulation monitoring.

[0033] A through-hole 5 is provided on the clamping arm 11, allowing sutures to pass through. Specifically, the through-hole 5 can be a through-channel that penetrates the clamping arm 11. During surgery, after the surgeon clamps the clamp body 1 onto the nerve being measured, sutures can be passed through the through-channel and then sutured to the tissue near the nerve. This provides a mechanical anchoring effect to the clamp body 1, effectively preventing electrode displacement or detachment caused by traction, irrigation, or tissue movement during surgery, ensuring the stability and reliability of the stimulation position throughout the monitoring process.

[0034] In this application, the openable clamping arm 11 structure enables rapid clamping and release of the measured nerve, which greatly facilitates the removal and placement of electrodes during surgery. By threading sutures and suturing and fixing the nerve in the tissue near the nerve, the problem of displacement of the clamp body 1 that may occur when relying solely on clamping force is solved, which significantly improves the stability of the monitoring process.

[0035] The clamp body 1 includes an overall X-shaped silicone clamp made of medical-grade silicone, which has good biocompatibility and flexibility. The silicone clamp includes a longer main clamping arm 111 and a shorter secondary clamping arm 112, which are ergonomically designed for easy gripping and operation by doctors, providing a structural basis for convenient operation.

[0036] The ends of the main clamping arm 111 and the auxiliary clamping arm 112 are respectively provided with clamps 113 that engage with each other. Each clamp 113 has a clamping groove 114 on its inner side (i.e., the opposite surface). The two opposing clamping grooves 114 together form a clamping part for accommodating and clamping the nerve being tested, which further increases the contact area and fit with the nerve, improves the stability of the clamping, and reduces the risk of damage to the nerve being tested by rigid clamping.

[0037] To enhance clamping stability and prevent slippage, the clamping surface of the clamp 113 located on the non-electrode plate 2 can be provided with anti-slip texture (not shown in the figure), such as tiny dot-shaped or grid-shaped protrusions, which can prevent clamping misalignment between the clamps 113.

[0038] The clamping groove 114 includes symmetrically arranged arc-shaped grooves, and the electrode pad 2 includes symmetrically arranged arc-shaped metal sheets, such as those made of 316L material. Furthermore, the arc-shaped metal sheets are embedded in or adhered to the groove surface of the clamping groove 114 to better conform to the nerve being tested through the formed arc-shaped or circular space. The curvature of the arc-shaped metal sheets matches the arc-shaped grooves, ensuring that the electrode pad 2 can achieve stable contact with the epineurium of the nerve at the maximum area when clamping the nerve, thereby ensuring effective transmission of the electrical stimulation signal.

[0039] In the specific configuration, the curved groove is designed as a semi-circular arc with a diameter of approximately 1 mm. In its natural state, the two clamps 113 at the bottom of the silicone clamp are either in contact or have a gap of approximately 0.1 mm, which, combined with the curved groove, avoids hard compression on the nerve tissue. The two electrode pads 2 in each group are symmetrically distributed, and the electrode pads 2 are designed as semi-circular arcs with a diameter of approximately 1 mm.

[0040] The curved groove and the curved metal sheet maximize and optimize the contact between the electrode and the nerve surface, which helps to reduce contact resistance, improve stimulation efficiency, and reduce potential damage to the nerve caused by excessive local current density due to point contact or line contact.

[0041] Both the main clamping arm 111 and the auxiliary clamping arm 112 are clamping structures with a certain width, and the main clamping arm 111 and the auxiliary clamping arm 112 have the same width. The electrode plates 2 are arranged in pairs between the main clamping arm 111 and the auxiliary clamping arm 112.

[0042] On the one hand, it can make the width direction of the clamping arm 11 form the length range of the clamping part, ensuring contact clamping of the nerve being tested. On the other hand, it can also facilitate the arrangement of electrode pads 2 to meet the needs of different arrangement states.

[0043] The electrical connection assembly 3 is encapsulated inside the clamping arm 11 and is used to establish an electrical connection between the electrode plate 2 and the external cable 4. Considering that the clamping arm 11 needs to open and close, the electrical connection assembly 3 preferably adopts a flexible structure, such as an FPC flexible circuit board or multi-strand flexible wires encapsulated inside the silicone arm. One end of the flexible circuit board or flexible wire is connected to the back of the electrode plate 2, and the other end converges and bundles in the cable 4, ensuring the reliability of the electrical connection while taking into account the mobility of the clamping arm 11, and ensuring the stability and effectiveness of the circuit connection under the opening and closing movement of the clamping wall.

[0044] The flexible circuit board or flexible wire serves as the electrical connection component 3, which adapts to the bending deformation when the clamping arm 11 opens and closes, avoiding the risk of electrical connection failure caused by repeated bending, and improving the durability and safety of the product.

[0045] The outer sheath of cable 4 is preferably made of medical-grade silicone. Cable 4 extends from the root of the clamping arm 112 of the clamp body 1 and is connected to the stimulation current generating device. The electrical stimulation signal generated by the stimulation current generating device is transmitted to the electrode pad 2 through cable 4 and electrical connection assembly 3 and applied to the nerve being tested.

[0046] The configuration of the electrode sheet 2 and the electrical connection assembly 3 can include different implementations: Combination Figure 2 In one embodiment, an electrode pad 2 is disposed at the center of the clamping portion of the main clamping arm 111 and the auxiliary clamping arm 112, forming a single set of stimulation electrodes. In this case, the electrical connection component 3 can be a pair of two independent flexible circuit boards or a pair of two independent flexible wires, with the flexible circuit boards or flexible wires connecting the two electrode pads 2 to the corresponding wires in the cable 4. This central arrangement of a single set of electrodes can meet the basic stimulation requirements, providing a simple and effective solution for basic continuous neural stimulation monitoring.

[0047] Combination Figure 3 In another embodiment, in order to achieve selective stimulation of different branches or different sites of the nerve, multiple sets of electrode pads 2 can be arranged at intervals along the width direction of the clamping arm 11.

[0048] For example, two or more pairs of electrode plates 2 can be provided. In this case, the electrical connection assembly 3 also needs corresponding multiple pairs of flexible circuit boards or multiple pairs of flexible wires to independently connect each set of electrode plates 2.

[0049] When multiple pairs of flexible wires are set, they need to be bundled together in cable 4 to complete the connection between electrode plate 2 and cable 4.

[0050] The stimulation current generator can be configured with multi-channel output to achieve independent control of each set of electrode pads 2, thereby enabling more precise monitoring of neural function.

[0051] Each set of electrode plates 2 is controlled independently. The flexible circuit board or flexible wire includes multiple independent pairs, and each set of electrode plates 2 is connected to the flexible circuit board or flexible wire respectively.

[0052] This configuration endows the device with spatial resolution capabilities, allowing doctors to selectively stimulate different parts of the nerve. This is crucial for locating specific functional bundles within the nerve, assessing the extent of nerve damage, or conducting more complex neurological function monitoring, greatly enhancing the device's functionality and clinical application value.

[0053] By designing multiple sets of electrode pads 2 as independently selectable, electrodes at different locations can be selected for precise local stimulation of the nerve or for monitoring conduction function along the nerve pathway without moving the clamp. This not only enhances the spatial resolution of nerve function monitoring and assessment, achieving multiple uses with a single device and reducing the hassle of changing instruments during surgery, but also, combined with a structure that facilitates easy suture fixation, improves the efficiency and accuracy of surgical monitoring, demonstrating the synergy between functional expandability and operational efficiency.

[0054] From the perspective of fixing the clamp body 1, the through holes 5 specifically include multiple through holes 5, each of which is configured as a through channel passing through the clamping arm 11, and the diameter of the through channel is approximately 1 mm. Preferably, the multiple through channels can be arranged in parallel, or they can be arranged in a square or other shapes on the clamping arm 11.

[0055] By using different settings for the suture channels, a variety of suture fixation options are provided. Doctors can choose the most suitable suture point and direction according to the anatomical structure of the surgical area, making fixation more flexible and reliable. Square arrangements and other methods enhance the stability of fixation.

[0056] By using multiple fixation points, the sutures can fix the main body of the clamp 1 to the surrounding tissue in a more balanced manner. This not only avoids the clamp rotation or loosening that may be caused by single-point fixation, but also ensures stable contact between the electrode pad 2 and the nerve, thereby improving the reliability of the stimulation signal. At the same time, the multi-point suture fixation method provides doctors with more flexible and stable intraoperative operation options, simplifies the fixation steps, and achieves an effective synergy between ease of operation and fixation stability.

[0057] The silicone clamp is made of medical-grade silicone, ensuring biosafety. The gripping surface of the clamp 113 has an anti-slip texture, which further enhances the reliability of the gripping and effectively improves the stability and reliability of the basic gripping function.

[0058] Utilizing biocompatible silicone, which provides moderate clamping force through its material texture, the device works in conjunction with the clamping groove 114 and the arc-shaped electrode pad 2 to ensure stable contact between the electrode and the nerve for effective electrical stimulation while minimizing the risk of mechanical damage to nerve tissue. The anti-slip texture further enhances clamping stability and prevents slippage. This allows the device to achieve its core function of continuous and reliable stimulation while also addressing the fundamental goal of intraoperative nerve protection, achieving a deep synergy between functional effectiveness and safety.

[0059] During use, manually or with a clamping instrument, press the upper two arms of the silicone clip to open the lower two arms. Then, place the electrode pads 2 of the silicone clip on both sides of the nerve tissue being tested. Release the upper part of the silicone clip, allowing it to spring back naturally and clamp the nerve tissue. At this point, each electrode pad 2 is in contact with the nerve tissue. Turn on the stimulation current; the current is conducted through the wires to the electrode pads 2, achieving nerve electrical stimulation. After confirming that the nerve tissue electrical stimulation function is working normally, use a surgical suture needle to guide the suture thread through the through-hole in the upper part of the silicone clip, suturing and fixing the silicone clip to other tissues near the nerve. This prevents relative movement between the silicone clip and the nerve tissue during continuous nerve electrical stimulation during the procedure. After completing the nerve electrical stimulation, cut the suture thread, manually or with a clamping instrument, clamp the upper part of the silicone clip to open the lower two arms, and remove the silicone clip from the nerve tissue.

[0060] The intraoperative continuous nerve stimulation device of this application, through the synergistic effect of an openable clamping structure, an optimized and fitting electrical contact interface, a built-in flexible electrical connection structure, and a suture fixation mechanism, enables the surgeon to quickly, conveniently, and non-invasively place and remove the stimulation electrodes, while maintaining the stability of the device body and the reliability of electrical contact in complex surgical environments.

[0061] The X-shaped silicone clip and clamping groove 114 make placement simple and quick, reducing operation time. At the same time, the flexible and biocompatible material minimizes the risk of mechanical damage to nerves.

[0062] The curved electrode and anti-slip texture provide stability to electrode pad 2, while the suture fixation mechanism of the through-hole 5 provides even greater stability, together ensuring continuous and reliable data during long-term surgery. The multi-electrode array design further elevates the function from simple stimulus-response monitoring to the level of neurospatial monitoring.

[0063] It should be noted that, where there is no conflict, the features in the embodiments of this application can be combined with each other.

[0064] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A device for continuous intraoperative nerve stimulation, characterized in that, include: The clamp body includes an openable clamping arm for clamping the nerve being tested; The clamping part of the clamping arm is provided with an electrode pad that can fit against the nerve being tested. An electrical connection component is provided inside the clamping arm. The clamping arm is connected to a cable. The electrical connection component is electrically connected between the electrode pad and the cable. A stimulation current generating device is connected to the cable. It also includes a through hole on the clamping arm through which the suture thread can pass.

2. The intraoperative continuous nerve stimulation device according to claim 1, characterized in that, The clamp body includes an X-shaped silicone clamp, which includes a main clamping arm and a secondary clamping arm of different lengths. The ends of the main clamping arm and the secondary clamping arm are respectively provided with clamping clamps that bite against each other. Each clamp is provided with a clamping groove to form a clamping part for the nerve being tested.

3. The intraoperative continuous nerve stimulation device according to claim 2, characterized in that, The clamping groove includes symmetrically arranged arc-shaped grooves, and the electrode sheet includes symmetrically arranged arc-shaped metal sheets, which are correspondingly attached to the groove surface of the arc-shaped groove.

4. The intraoperative continuous nerve stimulation device according to claim 2, characterized in that, The main clamping arm and the auxiliary clamping arm have the same width, and the electrode plates are arranged in pairs between the main clamping arm and the auxiliary clamping arm.

5. The intraoperative continuous nerve stimulation device according to claim 1, characterized in that, The electrical connection assembly includes a flexible circuit board or flexible wire encapsulated inside the clamping arm.

6. The intraoperative continuous nerve stimulation device according to claim 5, characterized in that, The electrode sheet includes a single set, and the single set of electrode sheets is disposed at the center of the clamping arm in the width direction; the flexible circuit board includes a pair of two pieces connected between the cable and the electrode sheet, or the flexible wire includes a pair of two lines connected between the cable and the electrode sheet.

7. The intraoperative continuous nerve stimulation device according to claim 5, characterized in that, The electrode sheet includes multiple sets, and the multiple sets of electrode sheets are spaced apart along the width direction of the clamping arm; The flexible circuit board includes multiple pairs connected between the cable and the electrode sheet, or the flexible wire includes multiple pairs connected between the cable and the electrode sheet, and the multiple pairs of flexible wires are bundled together in the cable.

8. The intraoperative continuous nerve stimulation device according to claim 7, characterized in that, Each group of electrode sheets is controlled independently, and the flexible circuit board or the flexible wire includes multiple independent pairs, with each group of electrode sheets connected to the flexible circuit board or the flexible wire respectively.

9. The intraoperative continuous nerve stimulation device according to claim 1, characterized in that, The through holes include multiple through holes, and each of the multiple through holes includes a through hole channel that passes through the clamping arm; The plurality of the through holes are arranged in parallel, or the plurality of the through holes are arranged in a square on the clamping arm; The suture passes through the insertion channel and is sutured to the tissue near the nerve being tested.

10. The intraoperative continuous nerve stimulation device according to claim 2, characterized in that, The silicone clamp is made of medical-grade silicone, and the surface of the clamping part is provided with anti-slip texture.

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