Testing device

Abstract

The embodiment of the invention discloses a testing device. The testing device comprises a cable, a connecting assembly and a stimulating assembly which are connected in sequence. Wherein the connecting assembly is provided with a limiting groove for limiting and fixing the implantable electrode, a plurality of conductive elastic sheets in conductive connection with the cable are arranged in the limiting groove, and the conductive elastic sheets are used for being detachably and electrically connected with a wire of the implantable electrode, so that the implanted implantable electrode is tested. The stimulation assembly is provided with a conductive probe electrically connected with the cable, and can apply a test electric signal to the nervous tissue to carry out a stimulation reaction test, thereby assisting in accurately confirming the position of the target spot. According to the testing device, the electrode testing function and the nerve stimulation testing function are integrated into a single device, the structure is compact, operation is visual, and the accuracy, smoothness and convenience of an operation are remarkably improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically to a testing device. Background Technology

[0002] Neuromodulation therapy is a neuromodulation treatment method that effectively treats related diseases by stimulating nerves with electrical pulses. The neuromodulation system required for this therapy typically includes a pulse generator and electrodes. The pulse generator is implanted subcutaneously, and the electrodes are implanted around the relevant nerve tissue. During the surgical implantation process, it is necessary not only to determine the electrode placement to ensure the correct nerve location, but also to test the entire implantation system to verify its therapeutic effect. Currently, most commercially available systems use a single test cable, which can only connect the electrode to the test stimulator for system testing after implantation. If the nerve target is not adequately verified before electrode implantation, and the test reveals poor placement or ineffectiveness after implantation, the electrode must be removed and reimplanted. This process not only prolongs the surgical time but also causes unnecessary secondary trauma and risks to the patient. Summary of the Invention

[0003] In view of this, the purpose of the present invention is to provide a testing device that can solve the problems of existing test cables having limited testing functions, low operating efficiency, and cumbersome operation.

[0004] This invention provides a testing apparatus, which includes: Cables; A connecting component is connected to one end of a cable. The connecting component has a limiting groove for fixing the implanted electrode. The limiting groove has multiple conductive springs that are electrically connected to the cable. The stimulation component is connected to the end of the connection component away from the cable, and the stimulation component is provided with a conductive probe that is electrically connected to the cable.

[0005] Optionally, the connecting assembly includes a first insulating housing connected to the cable, a limiting groove disposed on the first insulating housing, a circuit board electrically connected to the cable disposed inside the first insulating housing, and a conductive spring contact electrically connected to the circuit board.

[0006] Optionally, the first insulating shell is cylindrical, and the limiting groove extends along the length of the first insulating shell.

[0007] Optionally, the limiting groove is provided with symmetrical clearance grooves on both sides, the clearance grooves are laterally connected to the limiting groove, and the position of the clearance grooves corresponds to the position of the conductive spring.

[0008] Optionally, the conductive spring includes a clamping part and a connecting part. The clamping part is located in the limiting groove and has a U-shaped structure with its opening facing the opening of the limiting groove. One end of the connecting part is connected to the clamping part, and the other end extends to be connected to the circuit board.

[0009] Optionally, the stimulation component includes a second insulating housing wrapped around a conductive probe. The second insulating housing is connected to the end of the first insulating housing away from the cable. One end of the conductive probe extends into the first insulating housing and is electrically connected to the circuit board, while the other end extends out of the second insulating housing to form a probe contact.

[0010] Optionally, the limiting groove is provided with two conductive springs, and the stimulation component has two conductive probes. The two conductive springs and the two conductive probes are electrically connected in a one-to-one correspondence.

[0011] Optionally, the second insulating housing includes a bent portion and a fixed portion, the fixed portion being wrapped around the end of the conductive probe away from the connecting assembly, and the bent portion being located between the fixed portion and the first insulating housing.

[0012] Optionally, the second insulating housing is an insulating soft rubber housing.

[0013] Optionally, the testing apparatus also includes a plug connected to the end of the cable away from the connecting component.

[0014] The testing device provided in this invention includes a cable, a connecting component, and a stimulation component connected in sequence. The connecting component has a limiting groove for fixing the implanted electrode, and multiple conductive springs electrically connected to the cable are located within the limiting groove. This connecting component can be detachably electrically connected to the lead wire of the implanted electrode, thereby enabling testing of the implanted electrode. The stimulation component has conductive probes electrically connected to the cable, capable of applying test electrical signals to nerve tissue to perform stimulation response testing, thereby assisting in the accurate confirmation of target location. The testing device of this invention integrates electrode testing and nerve stimulation testing functions into a single device, with a compact structure and intuitive operation, significantly improving the accuracy, smoothness, and convenience of surgery. Attached Figure Description

[0015] The above and other objects, features and advantages of the present invention will become clearer from the following description of embodiments of the invention with reference to the accompanying drawings, in which: Figure 1 This is a schematic diagram of the overall structure of the testing device according to an embodiment of the present invention; Figure 2 This is a schematic diagram of the connection component and stimulation component structure according to an embodiment of the present invention; Figure 3 This is an exploded structural diagram of the connection component and the stimulation component according to an embodiment of the present invention.

[0016] Figure label: 10-Cable; 11-Limiting protrusion; 20-Connecting assembly; 21-First insulating shell; 211-Limiting groove; 212-Allowing groove; 22-Conductive spring; 221-Clamping part; 222-Connecting part; 30-Stimulation assembly; 31-Second insulating shell; 311-Bending part; 312-Fixing part; 32-Conductive probe; 321-Probe contact; 40-Circuit board; 50-Plug. Detailed Implementation

[0017] The present invention is described below based on embodiments, but the invention is not limited to these embodiments. In the detailed description of the invention below, certain specific details are described in detail. Those skilled in the art will fully understand the invention even without these details. To avoid obscuring the essence of the invention, well-known methods, processes, flows, elements, and circuits are not described in detail.

[0018] Furthermore, those skilled in the art should understand that the accompanying drawings provided herein are for illustrative purposes only and are not necessarily drawn to scale.

[0019] Unless otherwise expressly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0020] Unless the context explicitly requires it, words such as "including" or "comprising" throughout the invention document should be interpreted as including rather than exclusive or exhaustive; that is, meaning "including but not limited to".

[0021] In the description of this invention, it should be understood that the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance. Furthermore, in the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0022] Reference Figure 1 The testing device of the present invention includes an electrically connected cable 10, a connecting component 20, and a stimulation component 30. The cable 10, the connecting component 20, and the stimulation component 30 are arranged sequentially along the length of the cable 10. The overall structure of the testing device follows the design principles of linearity and integration, making the overall structure of the device simple, suitable for the limited space and flexible operating environment in the operating room, and also easy to sterilize.

[0023] The connecting component 20 is connected to one end of the cable 10 and has a limiting groove 211 for fixing the implantable electrode. The limiting groove 211 also contains multiple conductive spring contacts 22 that can be electrically connected to the implantable electrode. The connecting component 20 can be detachably electrically connected to the implantable electrode. The stimulation component 30 is connected to the connecting component 20 and has a conductive probe 32. The conductive probe 32 is used to directly contact the exposed nerve tissue and apply a test electrical signal to it to perform a stimulation response test on the nerve tissue in the area before implantation of the implantable electrode. This helps to accurately confirm the target location, improve the accuracy of electrode implantation, and avoid re-implantation of the implantable electrode due to inaccurate nerve location determination. This testing device is compact and easy to operate, and can simultaneously achieve two testing modes, significantly improving the smoothness, accuracy, and overall safety of neuromodulation surgery.

[0024] Furthermore, the testing device in this embodiment also includes a plug 50, which is connected to the end of the cable 10 away from the connecting component 20 for electrical connection with an external nerve testing stimulator, thereby transmitting the electrical signal emitted by the stimulator to the implanted electrode to perform testing on the implanted electrode. Optionally, in other embodiments, the other end of the cable 10 can also be directly and fixedly connected to a corresponding stimulation connector inside or outside the testing stimulation device, which helps to achieve device integration.

[0025] Reference Figure 2 and Figure 3 The connecting assembly 20 includes a first insulating housing 21 and a plurality of conductive springs 22 disposed within the first insulating housing 21. A circuit board 40 electrically connected to the cable 10 is also disposed within the first insulating housing 21. A limiting groove 211 is provided on the first insulating housing 21, and one end of each conductive spring 22 is electrically connected to the circuit board 40.

[0026] The first insulating housing 21 is cylindrical in shape for easy gripping and operation. A limiting groove 211 extends along the length of the first insulating housing 21, accommodating and guiding the assembly of the implantable electrode. The dimensions of the limiting groove 211 are closely fitted to the dimensions of the implantable electrode to maintain stable positioning. This design ensures that when the implantable electrode is inserted into the limiting groove 211 and contacts the conductive spring 22, the overall length of the implantable electrode is naturally aligned with the length of the cable 10, facilitating intraoperative operation.

[0027] The first insulating housing 21 has a receiving space (not shown in the figure), within which the circuit board 40 is fixed and limited. One end of the first insulating housing 21 near the cable 10 has a connection hole (not shown in the figure) communicating with the receiving space, through which one end of the cable 10 extends into the receiving space. Furthermore, a portion of the cable 10 located within the first insulating housing 21 is fitted with a limiting protrusion 11, the size of which is larger than the size of the connection hole, to effectively limit the connection and ensure the stability of the connection between the first insulating housing 21 and the cable 10.

[0028] The conductive core of cable 10 extends into the first insulating housing 21 and is electrically connected to the circuit board 40. A limiting groove 211 is recessed inward from the surface of the first insulating housing 21, and a through hole is provided at the bottom of the limiting groove 211 to communicate with the receiving space, facilitating the electrical connection between the conductive spring 22 and the circuit board 40. In this embodiment, the connecting assembly 20 includes two conductive springs 22 to respectively connect to two metal conductive rings on the connecting end of the implanted electrode. The two conductive springs 22 are spaced apart within the limiting groove 211 to avoid contact with each other and causing a short circuit.

[0029] Reference Figure 3 The conductive spring 22 includes a clamping portion 221 and a connecting portion 222. The clamping portion 221 is located within the limiting groove 211 and has a U-shaped structure, with its opening facing the opening of the limiting groove 211. The U-shaped structure forms an elastic clamp with automatic centering and self-adaptive capabilities. When the implanted electrode is inserted from the opening, it can be stably clamped by the clamping portion 221 and an electrical connection can be achieved. The connecting portion 222 is a conductive arm extending from the clamping portion 221, and in this embodiment, the clamping portion 221 and the connecting portion 222 are integrally formed. One end of the connecting portion 222 is connected to the clamping portion 221, and the other end extends to connect with the circuit board 40.

[0030] Furthermore, symmetrical clearance grooves 212 are provided on both sides of the limiting groove 211. The clearance grooves 212 are laterally connected to the limiting groove 211, and their positions correspond to the positions of the conductive spring 22. When the implanted electrode is inserted into the limiting groove 211, the U-shaped clamping portion 221 of the conductive spring 22 is compressed and expands to both sides, deforming. The clearance grooves 212 provide the necessary space to accommodate the elastic deformation of the clamping portion 221. This avoids increased insertion resistance due to insufficient deformation space in the clamping portion 221, ensuring that the conductive spring 22 can always apply a stable and uniform clamping force to the implanted electrode.

[0031] The stimulation assembly 30 includes a conductive probe 32 and a second insulating housing 31 surrounding the conductive probe 32. (See reference...) Figure 3The second insulating housing 31 is connected to the end of the first insulating housing 21 away from the cable 10. One end of the conductive probe 32 extends into the first insulating housing 21 and is electrically connected to the circuit board 40, while the other end extends out of the second insulating housing 31, forming a probe contact 321 for direct contact with nerve tissue.

[0032] The second insulating shell 31 includes a bending portion 311 and a fixing portion 312. The fixing portion 312 wraps around the end of the conductive probe 32 away from the connecting assembly 20, and the fixing portion 312 is isosceles trapezoidal in shape, which can stabilize the position of the probe contact 321 and facilitate handheld operation. The bending portion 311 is located between the fixing portion 312 and the first insulating shell 21. Its material is flexible and can be bent at will, so that the stimulation assembly 30 as a whole has an ergonomic operating angle, which facilitates precise positioning of nerve tissue during surgery.

[0033] In this embodiment, the second insulating shell 31 is an insulating soft rubber shell, such as a medical-grade silicone shell or a thermoplastic elastic shell. This structure has good insulation, flexibility, and grip comfort, allowing the bending part 311 to bend freely according to surgical needs, facilitating flexible use in various surgical scenarios. The first insulating shell 21 can be made of the same material as the second insulating shell 31 and manufactured using an integral molding process to achieve seamless connection and integrity of the structure. The first insulating shell 21 can be made with increased wall thickness or internal reinforcing ribs to provide sufficient structural rigidity while maintaining overall grip comfort. This design also allows the first insulating shell 21 to stably support the internal circuit board 40 and conductive spring 22, and ensure the dimensional accuracy of the limiting groove 211. Alternatively, the first insulating shell 21 can also be made of high-hardness medical-grade plastic and reliably connected to the second insulating shell 31 via injection molding, adhesive, or mechanical snap-fit ​​structures.

[0034] In this embodiment, the stimulation component 30 includes two conductive probes 32, which are spaced apart. Two conductive springs 22 are electrically connected to the two conductive probes 32 in a one-to-one correspondence, ensuring that the electrical signal paths are independent and do not interfere with each other.

[0035] Specifically, one conductive probe 32 and one conductive spring 22 are connected to the same electrical node on the circuit board 40 via leads, spring pins, or direct soldering. This electrical node is electrically connected to the first conductive core of the cable 10. Another conductive probe 32 and another conductive spring 22 are connected to another electrical node on the circuit board 40 in the same manner. This electrical node is electrically connected to the second conductive core of the cable 10. The first and second conductive cores of the cable 10 are used to connect to two independent channels of an external device (such as a test stimulator) to conduct electrical signals emitted by the test stimulator.

[0036] This clear and defined current path effectively ensures that test signals are transmitted through a complete circuit when testing neural tissue or implanted electrodes. This design guarantees testing accuracy, safety, and ease of switching between the two testing modes, thus enhancing system security.

[0037] It is understood that the number and connection relationship of the conductive spring 22 and the conductive probe 32 can be set according to specific circumstances, and the circuit connection between the connection component 20 and the stimulation component 30 is not limited to the connection structure described in the above embodiments.

[0038] In other embodiments, a mechanical selection switch can also be provided on the first insulating housing 21 or the second insulating housing 31. By manually toggling this switch, the signal path is switched to the conductive probe 32 or the conductive spring 22, thereby selecting the mode between nerve stimulation testing and electrode testing. Furthermore, a modular design can be adopted, with the connecting assembly 20 and the stimulation assembly 30 designed as detachable, independent functional modules. Each module interfaces with the front end of the cable 10 via a standard electrical interface (such as a miniature connector). Users can plug in different functional modules according to testing needs to switch to the corresponding testing mode, further improving the flexibility and adaptability of use.

[0039] The specific operation of the testing device of the present invention in neuromodulation implantation surgery is as follows: During surgery, once the target nerve tissue is exposed, it is necessary to confirm whether it is the correct stimulation target. At this time, the plug 50 of the testing device is connected to the testing stimulator. The operator holds the testing device and flexibly adjusts the bending part 311 to a suitable angle according to the specific stimulation site of the patient, so that the two probe contacts 321 can gently and stably contact the surface of the nerve tissue to be tested. Subsequently, the testing stimulator outputs a preset microcurrent stimulation signal. By observing whether the patient produces the expected physiological stimulation response, it can be determined whether the current nerve location is the target implantation site. If the location is confirmed to be accurate, the implantable electrode is implanted and brought out and fixed through a subcutaneous tunnel.

[0040] After identifying the target site and implanting the electrode, further verification of the electrode implantation and electrical connection is required. The operator aligns the lead wire of the implanted electrode with the conductive spring 22 in the testing device and embeds it into the limiting groove 211, thereby achieving a rapid electrical connection between the implanted electrode and the testing device. Reactivating the test stimulator outputs an electrical signal; if it still elicits a corresponding stimulation response, it indicates that the implanted electrode is correctly positioned and the electrical connection is good.

[0041] In this invention, the target nerve can be the hypoglossal nerve or the vagus nerve.

[0042] The testing device of this invention allows for flexible switching between two testing modes via a shared cable. It enables target localization and efficacy verification before implantable electrode placement, and rapid system-level testing after electrode placement. This avoids repeat surgeries due to target localization errors or electrode failure, significantly improving the efficiency and safety of neuromodulation surgery.

[0043] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. For those skilled in the art, the present invention can be modified and varied in various ways. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principle of the present invention should be included within the scope of protection of the present invention.

Claims

1. A testing device, characterized in that, The testing apparatus includes: Cable (10); A connecting component (20) is connected to one end of the cable (10). The connecting component (20) is provided with a limiting groove (211) for limiting and fixing the implanted electrode. The limiting groove (211) is provided with a plurality of conductive springs (22) that are electrically connected to the cable (10). Stimulation component (30) is connected to the end of connection component (20) away from cable (10), and stimulation component (30) is provided with conductive probe (32) electrically connected to cable (10).

2. The testing apparatus according to claim 1, characterized in that, The connection assembly (20) includes a first insulating housing (21) connected to the cable (10), a limiting groove (211) is disposed on the first insulating housing (21), a circuit board (40) electrically connected to the cable (10) is disposed inside the first insulating housing (21), and a conductive spring (22) is electrically connected to the circuit board (40).

3. The testing apparatus according to claim 2, characterized in that, The first insulating shell (21) is cylindrical, and the limiting groove (211) extends along the length of the first insulating shell (21).

4. The testing apparatus according to claim 3, characterized in that, The limiting groove (211) is symmetrically provided with clearance grooves (212) on both sides. The clearance grooves (212) are laterally connected to the limiting groove (211), and the position of the clearance grooves (212) corresponds to the position of the conductive spring (22).

5. The testing apparatus according to claim 2, characterized in that, The conductive spring (22) includes a clamping part (221) and a connecting part (222). The clamping part (221) is located in the limiting groove (211) and the clamping part (221) is a U-shaped structure with its opening facing the opening of the limiting groove (211). One end of the connecting part (222) is connected to the clamping part (221), and the other end extends to be connected to the circuit board (40).

6. The testing apparatus according to claim 2, characterized in that, The stimulation component (30) includes a second insulating shell (31) wrapped around the conductive probe (32). The second insulating shell (31) is connected to the end of the first insulating shell (21) away from the cable (10). One end of the conductive probe (32) extends into the first insulating shell (21) and is electrically connected to the circuit board (40). The other end extends out of the second insulating shell (31) to form a probe contact (321).

7. The testing apparatus according to claim 6, characterized in that, The limiting groove (211) is provided with two conductive springs (22), and the stimulation component (30) is provided with two conductive probes (32). The two conductive springs (22) and the two conductive probes (32) are electrically connected in a one-to-one correspondence.

8. The testing apparatus according to claim 6, characterized in that, The second insulating housing (31) includes a bent portion (311) and a fixing portion (312), the fixing portion (312) wrapping around the end of the conductive probe (32) away from the connecting assembly (20), and the bent portion (311) being located between the fixing portion (312) and the first insulating housing (21).

9. The testing apparatus according to claim 6, characterized in that, The second insulating shell (31) is an insulating soft rubber shell.

10. The testing apparatus according to any one of claims 1 to 9, characterized in that, The testing device also includes a plug (50) connected to one end of the cable (10) away from the connecting assembly (20).

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