Implant device and implant system

Abstract

This disclosure provides an implantation device and an implantation system. The implantation device includes: a receiving mechanism, the receiving mechanism including a first receiving portion; and an implantation component, the implantation component being housed in the first receiving portion, at least a portion of the implantation component being movable relative to the first receiving portion to drive the movement of electrodes attached to the implantation component; wherein the electrodes are capable of acquiring electrical signals from biological tissue or applying electrical stimulation to biological tissue. The solution of this disclosure can reliably improve at least one of implantation efficiency and implantation accuracy.

Description

Technical Field

[0001] This disclosure relates to the field of brain-computer interface technology, and more particularly to an implantation device and implantation system. Background Technology

[0002] Early brain-computer interface (BCI) technologies used rigid electrodes, primarily made of rigid metals and semiconductor materials such as gold and tungsten. These electrodes have a high Young's modulus, which differs significantly from the Young's modulus of soft brain tissue. This can lead to rejection reactions within the biological system, causing electrode failure. Furthermore, rigid electrodes are prone to damaging biological tissue during implantation and use, affecting the long-term stability of EEG signals. In addition, insufficient rigidity of metal electrodes can affect the accuracy of electrode implantation, and the assembly process is complex, making precise alignment of rigid electrodes difficult. These problems directly impact the quality and efficiency of signal transmission between biological tissue and electrodes. To address the problems of traditional rigid electrodes, flexible electrodes (also known as flexible microelectrodes) have emerged. Flexible electrodes are typically made of soft materials such as polyethylene glycol, silk fibroin, polystyrene, polyetherimide polymers, and hydrogels.

[0003] With the development of brain-computer interface technology, both scientific research and clinical applications require the implantation of flexible electrodes to be completed in the shortest possible time. On the one hand, shortening the operation time can reduce the risks to patients during the procedure, such as the side effects caused by prolonged anesthesia; on the other hand, for scientific research experiments, improving implantation efficiency can accelerate the experimental process and reduce experimental costs.

[0004] Implanting only a single flexible electrode can only collect a small amount of neural signals from a single point, which is insufficient to support a high-performance brain-computer interface. Implanting multiple flexible electrodes can cover more neurons, increasing the richness of neural signals and thus providing a more accurate and comprehensive source of neural signals for the brain-computer interface, enabling more complex functions such as more precise motor control and richer sensory feedback. Therefore, a technology that can implant multiple flexible electrodes simultaneously or sequentially is needed.

[0005] Flexible electrodes are extremely small and soft, about the width of a human hair and only about one-tenth the thickness. Accurate implantation into specific areas of the brain requires extremely high navigation precision. On the one hand, the brain's structure is highly complex, with different areas having different functions; only by accurately implanting the electrode into the target functional area can the required neural signals be acquired. On the other hand, the brain has abundant blood vessels and nerve tissue; precise navigation during implantation is essential to avoid damaging these vital structures and ensure patient safety and normal postoperative neurological function. Even with flexible electrode wires, the precision and safety of implantation surgery remain critical issues.

[0006] In summary, how to implant electrodes into the target location more quickly, efficiently, and accurately, while avoiding damage to surrounding brain tissue, is a direction that requires continued research. Summary of the Invention

[0007] The technical problem solved by this disclosure is to provide an improved implantation device and implantation system.

[0008] To address the aforementioned technical problems, a first aspect of this disclosure provides an implantation device, comprising: a receiving mechanism including a first receiving portion; and an implantation component housed in the first receiving portion, wherein at least a portion of the structure of the implantation component is movable relative to the first receiving portion to drive the movement of an electrode attached to the implantation component; wherein the electrode is capable of acquiring electrical signals from biological tissue or applying electrical stimulation to biological tissue.

[0009] Optionally, the implantation assembly includes: a plurality of implantation needles, each of the implantation needles extending along a first direction and having opposing first and second ends, an electrode attached to the first end, and the second end for receiving a driving force along the first direction, the driving force being capable of triggering and / or controlling the movement of the implantation needle in the first direction.

[0010] Optionally, a plurality of receiving holes are provided on the first receiving portion, and the plurality of receiving holes correspond one-to-one with the plurality of implantation needles, with at least a portion of the implantation needles being received in the corresponding receiving holes.

[0011] Optionally, the first receiving portion can rotate or translate in a plane perpendicular to the first direction, and each of the plurality of receiving holes can move sequentially to a corresponding preparatory position as the first receiving portion moves. When the receiving hole is in the corresponding preparatory position, the implantation needle corresponding to the receiving hole can be triggered and / or controlled by the driving force so that the implantation needle moves in the first direction.

[0012] Optionally, the plurality of receiving holes are distributed in a single row or multiple rows in a plane perpendicular to the first direction.

[0013] Optionally, when the plurality of receiving holes are distributed in multiple rows in a plane perpendicular to the first direction, adjacent rows of receiving holes are arranged alternately.

[0014] Optionally, the multiple rows of receiving holes are arranged in concentric arcs.

[0015] Optionally, the second end of the implantation needle can receive a driving force from the implantation rod along the first direction, the implantation rod having opposing third and fourth ends, the third end being used to cooperate with the second end to trigger and / or control the movement of the implantation needle in the first direction.

[0016] Optionally, an actuation mechanism is provided on the third end of the implantation rod, the actuation mechanism being used to cooperate with the second end of the implantation needle to trigger and / or control the movement of the implantation needle in the first direction.

[0017] Optionally, the actuating mechanism can be connected to the second end of the implantation needle in a concave-convex fit or in a surface contact manner, so that the force transmission direction between the actuating mechanism and the implantation needle is aligned with the axial direction of the implantation needle, wherein the force transmission direction is consistent with the first direction.

[0018] Optionally, the first receiving portion includes: a first main body portion, wherein the plurality of receiving holes are disposed through the first main body portion along the first direction, the first main body portion having a first side and a second side opposite to each other along the first direction, and the first side being closer to the third end of the implant rod than the second side.

[0019] Optionally, the inner diameter of the receiving hole is interference-fitted with the outer diameter of the implantation needle.

[0020] Optionally, the rotation or translation movement is achieved by rotating the first receiving portion by a predetermined angle or moving it by a predetermined distance.

[0021] Optionally, the receiving mechanism further includes a second receiving portion for receiving redundant sections of the electrode.

[0022] Optionally, the electrode includes a flexible electrode wire, with redundant sections of the flexible electrode wire folded and housed within the second accommodating portion. The folded shape includes a plurality of U-shaped bends arranged sequentially along the length direction of the second accommodating portion, with adjacent U-shaped bends having opposite opening directions. The redundant sections are folded and housed within the second accommodating portion under conditions where a liquid medium is present within the second accommodating portion. Furthermore, the flexible electrode wire is configured such that when the distal end of the flexible electrode wire is pulled in a distal direction, the flexible electrode wire can be gradually released from the second accommodating portion and extend in a generally straight line.

[0023] Optionally, the second accommodating portion includes: a second main body portion; at least one receiving slot formed in the second main body portion and open toward at least one side, the redundant section being accommodated in the receiving slot; and a constraint cover for constraining the redundant section from one side.

[0024] Optionally, the implantation needle includes a needle body and a tungsten needle assembly located at an end of the needle body along the first direction, wherein the end of the tungsten needle assembly away from the needle body is adapted to form a first end, and the end of the needle body away from the tungsten needle assembly is adapted to form a second end.

[0025] Optionally, the needle body includes: a central tube, which is solid or has a solid shaft inside, and the central tube is fixedly connected to the tungsten needle assembly; and an outer tube, which is sleeved on the central tube, and the central tube can reciprocate within the outer tube along the first direction.

[0026] Optionally, the implanted needle further includes: an elastic structure sleeved on the central tube and located inside the outer tube, the elastic deformation direction of the elastic structure being parallel to the first direction; and a limiting ring located on the outer surface of the central tube; wherein, the two ends of the elastic structure along the elastic deformation direction respectively abut against the lower end of the outer tube along the first direction and the limiting ring, or are fixedly connected to the limiting ring and the upper end of the outer tube along the first direction.

[0027] Optionally, the accommodating mechanism includes a third accommodating portion independent of the first accommodating portion, the third accommodating portion being used to accommodate a signal acquisition / stimulator body coupled to the electrode.

[0028] Optionally, the first accommodating portion and the third accommodating portion are integrally formed.

[0029] Optionally, the accommodating spaces formed by the first accommodating portion and the third accommodating portion are arranged opposite to each other.

[0030] Optionally, the receiving mechanism includes a base, and the mutually opposing sides of the base are respectively adapted to form the first receiving portion and the third receiving portion.

[0031] Optionally, the third receiving portion includes: a third main body portion having a receiving space to receive the signal acquisition / stimulator body; and a retaining structure via which the signal acquisition / stimulator body is detachably held in the third main body portion.

[0032] Optionally, the retaining structure includes: a clamping portion movable relative to the third main body portion; and a retaining mechanism for holding the clamping portion in a first position, wherein the clamping portion in the first position is adapted to fix the signal collector / stimulator body to the third main body portion.

[0033] Optionally, the holding structure further includes an operating part for triggering the clamping part to move relative to the third main body to release or clamp the signal collector / stimulator body.

[0034] Optionally, the electrode includes multiple electrode wires, wherein each electrode wire has a fifth end and a sixth end along its extension direction, the fifth end of the electrode wire is physically connected to the implanted component, and the sixth end of the electrode wire is coupled to the signal acquisition / stimulator body.

[0035] Optionally, the implantation device further includes a cover detachably connected to the first receiving portion to cover at least a portion of the structure of the implantation component.

[0036] Optionally, the housing has an observation window through which the connection area between the implanted component and the electrode is visible to the outside.

[0037] To address the aforementioned technical problems, a second aspect of this disclosure provides an implantation system, which includes the implantation device described in the first aspect.

[0038] Compared with the prior art, the technical solutions of the embodiments of this disclosure have the following beneficial effects: By employing the scheme disclosed herein, a large number of electrodes can be rapidly and efficiently implanted through the coordinated movement of the implantation component and the first receiving portion.

[0039] Specifically, the implantation component includes multiple implantation needles, and the first receiving portion is provided with multiple receiving holes to receive or fix the multiple implantation needles, thereby achieving compact, high-density reception and fixation of multiple implantation needles. For example, the number of implantation needles that the implantation component of this disclosure can accommodate in a single operation is far greater than the maximum number of implantation needles that traditional implantation devices can accommodate in a single operation (1-6 needles), significantly improving the space utilization rate of the implantation device. Therefore, a larger number of electrode wires can be implanted in a single implantation operation, enabling high-throughput or even ultra-high-throughput electrode implantation in a short time during a single implantation operation, which is beneficial to significantly improving implantation efficiency.

[0040] Furthermore, a single implantation needle can move along a first direction under the action of a driving force, and the first receiving portion can move as a whole in a plane perpendicular to the first direction, so as to apply a driving force to each implantation needle individually. This enables rapid needle changing and reliably improves implantation efficiency.

[0041] The present invention employs a dedicated second receiving section on the receiving mechanism to receive redundant sections of the electrode. The redundant section refers to the section where the flexible electrode wire naturally falls out after being pre-connected to the implantation needle.

[0042] In existing technologies, after the electrode wire and the implantation needle are pre-connected, there may be a long redundant length of the electrode wire. If this redundant length is not handled properly, it can significantly reduce implantation efficiency and even lead to implantation failure. This is especially true when there is more than one electrode wire to be implanted, requiring better handling measures for this redundant length. In contrast, the solution disclosed in this invention provides an additional second receiving part on the receiving mechanism, which does not interfere with the first receiving part. The redundant section of the flexible electrode wire is reliably and independently housed in the second receiving part, preventing the redundant sections of adjacent flexible electrode wires from tangling due to uncontrolled scattering, and also helping to prevent the redundant sections from interfering with the movement of the implantation needle and / or the first receiving part. Therefore, the problem of uncontrolled scattering of the redundant part of the flexible electrode wire can be reliably handled, ensuring successful implantation of the flexible electrode wire without affecting the implantation depth, while simultaneously guaranteeing success rate and implantation efficiency.

[0043] The implantation needle using this disclosure includes a needle body and a tungsten needle assembly connected to its end. The needle body is solid at least in the central region to ensure stability of movement along the axial direction (i.e., the first direction). Through the cooperation of the elastic structure and the limiting ring, the needle body and the tungsten needle assembly reciprocate along the first direction to complete the implantation action.

[0044] The present invention incorporates a third receiving portion on the receiving mechanism, which is independent of the first receiving portion and configured to accommodate the signal acquisition / stimulator body. Thus, the implantation component and the signal acquisition / stimulator body are integrated simultaneously on the receiving mechanism without interference. Both the electrode and the signal acquisition / stimulator body are housed within the receiving mechanism and are movable as a whole. During implantation, the operator can freely move the implantation device without pulling on the electrode, preventing unintended detachment from the implantation needle. Attached Figure Description

[0045] Figure 1 This is a schematic diagram of an implantation system according to an embodiment of the present disclosure; Figure 2 This is a schematic diagram of an implantation device according to an embodiment of the present disclosure; Figure 3 yes Figure 2 Exploded view of the structure shown; Figure 4 yes Figure 2 A schematic diagram of the implanted component from another perspective; Figure 5 yes Figure 4 A cross-sectional view of the structure shown along the first direction; Figure 6 This is a schematic diagram of an implantation needle according to an embodiment of the present disclosure; Figure 7 yes Figure 6Exploded view of the structure shown; Figure 8 yes Figure 2 A schematic diagram of the implanted component from another perspective; Figure 9 This is an assembly schematic diagram of a microelectrode driver and implantation device according to an embodiment of the present disclosure; Figure 10 yes Figure 9 Enlarged view of a portion of the central structure; Figure 11 yes Figure 10 An exploded view of the upper part of the structure shown. Figure 12 yes Figure 11 Exploded view of the implanted rod; Figure 13 This is a schematic diagram of a calibrator according to an embodiment of the present disclosure. Detailed Implementation

[0046] To make the above-mentioned objectives, features and beneficial effects of this disclosure more apparent and understandable, specific embodiments of this disclosure will be described in detail below with reference to the accompanying drawings.

[0047] Figure 1 This is a schematic diagram of an implantation system 100 according to an embodiment of the present disclosure.

[0048] This solution can be applied to the field of invasive brain-computer interfaces, utilizing the implantation system 100 to implant an implant into a target region of biological tissue. The implant may include at least a portion of a medical device structure, such as a microelectrode. The microelectrode, for example, includes electrode 3 (e.g., Figure 2 As shown, electrode 3 can collect electrical signals from biological tissue or apply electrical stimulation to biological tissue. The implantation system 100 is configured to implant the electrode wire 31 of electrode 3 into a target area. In this embodiment, electrode 3 is preferably a flexible electrode, and correspondingly, the electrode wire 31 implanted into the target area via implantation system 100 is a flexible electrode wire. Biological tissue can be, for example, brain tissue, spinal cord nerve tissue, or peripheral nerve tissue.

[0049] In one embodiment, the signal acquisition / stimulator of the brain-computer interface includes, for example, an electrode 3 and a signal acquisition / stimulator body 32. The electrode 3, also referred to as an electrode unit, may include one or more electrode wires 31. The multiple electrode wires 31 are coupled to the signal acquisition / stimulator body 32. Specifically, the electrode wires 31 may have opposing distal ends (also referred to as the fifth end) and proximal ends (also referred to as the sixth end) along their extension direction. The signal acquisition / stimulator body 32 is located at and coupled to the proximal end of the electrode wires 31, and the distal end of the electrode wires 31 is adapted to be implanted into a target region. The target region may include a target location, or one target region corresponds to one target location. The target region or target location refers to the area or location of biological tissue where electrical signals need to be acquired or where electrical stimulation is applied.

[0050] For ease of description, the direction in which the control electrode 3 moves to implant into the target area during the implantation operation of the implantation system 100 is denoted as the first direction D1. Here, "above" and "upper side" refer to the opposite direction of the first direction D1, and "below" and "lower side" refer to the positive direction of the first direction D1 (i.e., the direction of the arrow). Next, an exemplary demonstration and explanation will be given using the implantation system 100 for implanting the electrode wire 31 into brain tissue. In this application scenario, the target area of ​​the brain tissue to which the electrode wire 31 will be implanted is typically located below the structure of the implantation system 100 carrying the electrode 3 along the first direction D1.

[0051] Specifically, refer to Figure 1 The implantation system 100 may include an implantation device 100A, a microelectrode driver 100B, a fixation platform 100C, and a control terminal (not shown).

[0052] The implantation device 100 may also be referred to as a multi-needle array signal acquisition / stimulator mounting accessory (which may be simply referred to as a "mounting accessory" or "mounting module"). The implantation device 100 is configured to carry one or more implantation needles 21 (e.g., Figure 2 (As shown). Multiple implantation needles 21 correspond one-to-one with multiple electrodes 3, wherein each implantation needle 21 is pre-connected to the electrode wire 31 of the corresponding electrode 3. Alternatively, two electrode wires 31 may correspond to one implantation needle 21.

[0053] The micro-motor driver 100B can also be referred to as a multi-axis motion platform. The microelectrode driver 100B is configured to adjust the implantation position of multiple electrode wires 31, quickly change the implantation needle 21, and complete the implantation of the electrode wires 31. The implantation device 100A is detachably connected to the microelectrode driver 100B. Driven by the microelectrode driver 100B, the implantation device 100A can adjust its relative position to the target area in three dimensions and move along the first direction D1 to complete the implantation of the electrode wires 31.

[0054] The fixed platform 100C is configured to provide a fixed initial position, also referred to as the base position or reference position of the implantation system 100. The microelectrode actuator 100B is mounted on the fixed platform 100C. The fixed platform 100C may include a mobile trolley 101, a robotic arm 102, etc. The robotic arm 102 may be, for example, the robotic arm of an implantation robot or other auxiliary implantation device. The mobile trolley 101 is supported on the ground and can move the implantation device 100A, the microelectrode actuator 100B, and the robotic arm 102 as a whole.

[0055] The control terminal is electrically and / or communicatively connected to the microelectrode driver 100B. The control terminal is configured to control the movement of the microelectrode driver 100B to achieve at least one of the following actions: position adjustment, rapid needle change, and implantation. The control terminal may include a control box and a handle. The control box may integrate an operating system such as a microcontroller. The operator manipulates the handle to control the microelectrode driver 100B to perform corresponding actions via the control box.

[0056] Next, combined Figures 2 to 5 The specific structure of the implantable device 100A is described in detail.

[0057] Specifically, the implantation device 100A includes a receiving mechanism 1 and an implantation component 2. The receiving mechanism 1 is adapted to form a base for the implantation device 100A and is at least configured to fix the implantation component 2. For example, the receiving mechanism 1 includes a first receiving portion 11 for receiving the implantation component 2. The implantation component 2 is pre-attached with an electrode 3. For example, the implantation component 2 is pre-connected to the electrode wire 31 of the electrode 3. Furthermore, the distal end of the implantation component 2 is pre-physically connected to the electrode wire 31.

[0058] Furthermore, at least a portion of the structure of the implantation component 2 is movable relative to the first receiving portion 11 to drive the electrode 3 attached to the implantation component 2 to move.

[0059] In one specific embodiment, the implantation component 2 may include a plurality of implantation needles 21, wherein each implantation needle 21 extends along a first direction D1 and has a first end 21A and a second end 21B opposite to each other. The first end 21A is located below the second end 21B.

[0060] Electrode 3 is attached to the first end 21A, such as Figure 4 As shown. For example, the distal end of the electrode wire 31 may be provided with an electrode ring (also referred to as an electrode wire hole), which is sleeved on the first end 21A. As another example, the first end 21A and the distal end of the electrode wire 31 may be connected by a biodegradable, biocompatible adhesive.

[0061] The second end 21B is used to receive a driving force along the first direction D1, which can trigger and / or control the movement of the implantation needle 21 in the first direction D1. In some embodiments, the driving force can be applied to the second end 21B by the microelectrode driver 100B.

[0062] Continue to refer to Figures 2 to 4 The base 1A of the receiving mechanism 1 is generally elongated in shape, extending along a first direction D1. The length of the base 1A extending along the first direction D1 is adapted to the length of the implantation needle 21. In some embodiments, the first receiving portion 11 and the base 1A are separate components, connected to the base 1A by fasteners 14 such as screws. In some embodiments, the first receiving portion 11 and the base 1A may be integrally formed.

[0063] Furthermore, the base 1A along the first direction D1 may include adjacent first segment 1Aa and second segment 1Ab, wherein the first segment 1Aa is located below the second segment 1Ab. The first segment 1Aa is generally plate-shaped and is used to connect with the first receiving portion 11. There is a large gap between the first segment 1Aa and the implantation needle 21. The second segment 1Ab is generally semi-cylindrical and is abutted or adjacent to the implantation needle 21.

[0064] Furthermore, a plurality of receiving holes 111 may be formed on the first receiving portion 11, and the plurality of receiving holes 111 correspond one-to-one with a plurality of implantation needles 21. At least a portion of the implantation needle 21 is received in the corresponding receiving hole 111. For example, the end of the first receiving portion 11 away from the second segment 1Ab may protrude outward in a plane perpendicular to the first direction D1 to form a first main body portion 114. A plurality of holes extending along the first direction D1 are formed on the first main body portion 114 to form receiving holes 111. The first end 21A of the implantation needle 21 passes through the corresponding receiving hole 111 along the first direction D1. The electrode 3 is connected to the corresponding implantation needle 21 on the side of the first main body portion 114 facing the first direction D1.

[0065] In some embodiments, the inner diameter of the receiving hole 111 is interference-fitted with the outer diameter of the implantation needle 21. As a result, the maximum distance by which the implantation needle 21 extends out of the corresponding receiving hole 111 along the first direction D1 and its displacement in a plane perpendicular to the first direction D1 are both limited, preventing the implantation needle 21 from unexpectedly falling off or wobbling from the receiving mechanism 1.

[0066] In some embodiments, the end of the first receiving portion 11 near the second segment 1Ab can protrude outward to form a mating body portion 115. The mating body portion 115 also has a plurality of through holes extending along the first direction D1. The plurality of through holes correspond one-to-one with a plurality of implantation needles 21. The second end 21B of the implantation needle 21 passes through the corresponding through hole, so that a portion of the implantation needle 21 near the second end 21B is located near the second segment 1Ab. Thus, the implantation needle 21 is fixed at multiple points along its length by the first receiving portion 11 to ensure the reliability of the fixation. Furthermore, the receiving hole 111 corresponding to the same implantation needle 21 and the through hole opened on the mating body portion 115 are precisely aligned in the first direction D1 to ensure that the extension direction of the implantation needle 21 housed in the receiving mechanism 1 is parallel to the first direction D1, so as to facilitate the precise movement of the implantation needle 21 along the first direction D1 during subsequent implantation operations.

[0067] Further, refer to Figure 3 The first receiving portion 11 is generally plate-shaped with both ends folded to form semi-circular flanges. Through holes are provided on the semi-circular flanges for the implantation needle 21 to pass through. A gap exists between the plate-shaped structure and the implantation needle 21. This ensures reliable reception of the implantation needle 21 while also saving material.

[0068] In some embodiments, the plurality of receiving holes 111 are distributed in a single row or multiple rows in a plane perpendicular to the first direction D1. Figures 2 to 5 The following example illustrates a single-row distribution. Specifically, the cross-section of the first main body 114 and the mating main body 115 along the first direction D1 can be arc-shaped, and the plurality of receiving holes 111 and the plurality of through holes can be arranged in a semi-circular, at least partially circular, or arc-shaped manner along the outer contour of the arc. Correspondingly, the plurality of implantation needles 21 are arranged in an arc shape.

[0069] In one variation, when the multiple receiving holes 111 are distributed in multiple rows in a plane perpendicular to the first direction D1, adjacent rows of receiving holes 111 are staggered. This facilitates increasing the number of implantation needles 21 that the first receiving portion 11 can accommodate in a single procedure, thereby increasing the number of electrodes 3 implanted in a single procedure.

[0070] In some embodiments, the multiple rows of receiving holes 111 may be arranged in concentric arcs. The first receiving portion 11 can rotate about its own axis to move the receiving holes 111 one by one to the corresponding preparatory positions described below, thereby realizing the implantation of the electrode 3.

[0071] In some embodiments, the first receiving portion 11 is capable of rotational or translational movement in a plane perpendicular to the first direction D1. Each of the plurality of receiving holes 111 can sequentially move to a corresponding preparatory position as the first receiving portion 11 moves. When the receiving hole 111 is in the corresponding preparatory position, the implantation needle 21 corresponding to the receiving hole 111 can be triggered and / or controlled by the aforementioned driving force to move the implantation needle 21 in the first direction D1. Specifically, this rotational or translational movement can be achieved by rotating the first receiving portion 11 by a predetermined angle or moving it by a predetermined distance.

[0072] Specifically, the corresponding preparatory position can be associated with the implantation rod 511 mentioned below (e.g. Figure 10 The position corresponds to that shown. The implantation rod 511 is configured to move along the first direction D1 to apply a driving force to the implantation needle 21 located below it. Accordingly, the current position of the implantation needle 21 located below the implantation rod 511 is the corresponding preparatory position (ready to receive the driving force). During the implantation operation, multiple implantation needles 21 move sequentially to the corresponding preparatory positions, and the second end 21B of the implantation needle 21 receives the driving force from the implantation rod 511 along the first direction D1, thereby implanting the electrode 3 attached to its first end 21A into the target area.

[0073] Combination Figures 10 to 12 The implantation rod 511 may extend along the first direction D1 and have opposing third ends 511A and fourth ends 511B, wherein the third end 511A is located below the fourth end 511B. The third end 511A is used to cooperate with the second end 21B to trigger and / or control the movement of the implantation needle 21 in the first direction D1.

[0074] Furthermore, an actuation mechanism 513 may be provided on the third end 511A of the implantation rod 511. The actuation mechanism 513 is used to cooperate with the second end 21B of the implantation needle 21 to trigger and / or control the movement of the implantation needle 21 in the first direction D1.

[0075] In some embodiments, the actuating mechanism 513 may be connected to the second end 21B of the implantation needle 21 in a concave-convex fit or in surface contact, such that the force transmission direction between the actuating mechanism 513 and the implantation needle 21 is aligned with the axial direction of the implantation needle 21, wherein the force transmission direction is consistent with the first direction D1. For example, refer to Figure 12The actuation mechanism 513 may include a recessed portion extending from the third end 511A toward the fourth end 511B, and correspondingly, the second end 21B of the implantation needle 21 may protrude in a direction away from the first end 21A to form a protrusion. As the implantation rod 511 moves along the first direction D1 and contacts the implantation needle 21 which has moved to the corresponding preparatory position, the recessed portion and the protrusion engage with each other. This engagement is effective throughout the entire movement of the implantation rod 511 driving the implantation needle 21 along the first direction D1. Both the recessed portion and the protrusion may be spherical.

[0076] This increases the contact area between the implantation rod 511 and the implantation needle 21, preventing deformation or wear of the implantation needle 21 or failure of force transmission due to excessive local stress, uneven force distribution, or alignment errors. Furthermore, the implantation needle 21 can receive the driving force applied by the implantation rod 511, for example, with its second end 21B embedded in the implantation rod 511, which helps prevent slippage of the implantation needle 21 during the pushing process. The concave structure also has an automatic alignment function, which can automatically compensate for minor coaxiality deviations during assembly, ensuring that the driving force is transmitted along the first direction D1, preventing radial wobbling of the implantation needle 21 due to force point offset, and ensuring the accuracy of the electrode 3 implantation position.

[0077] In some embodiments, the diameter of the implantation rod 511 may be larger than the diameter of the implantation needle 21. In other words, the implantation rod 511 is thicker than the implantation needle 21. The implantation rod 511 is directly driven by the motor (not shown) of the microelectrode driver 100B. Designing the implantation rod 511 to be thicker helps ensure its overall strength and avoids insufficient strength or even accidental breakage. Furthermore, the thicker implantation rod 511 can also increase the contact area with the implantation needle 21, ensuring that the driving force is reliably and smoothly transmitted to the implantation needle 21.

[0078] Therefore, by adopting this embodiment, multiple implantation needles 21 can be compacted, accommodated, and fixed in a high-density manner. For example, the number of implantation needles 21 that the implantation component 2 of this disclosed embodiment can accommodate in a single operation is far greater than the maximum number of implantation needles that traditional implantation devices can accommodate in a single operation (1-6 needles), significantly improving the space utilization rate of the implantation device 100A. As a result, a greater number of flexible electrode wires can be implanted in a single implantation operation, thereby enabling high-throughput or even ultra-high-throughput electrode 3 implantation in a short time during a single implantation operation, which is beneficial to significantly improving implantation efficiency.

[0079] Furthermore, a single implantation needle 21 can move along the first direction D1 under the action of a driving force, and the first receiving portion 11 can move as a whole in a plane perpendicular to the first direction D1, so as to apply a driving force to each implantation needle 21 one by one. As a result, rapid needle changing can be achieved, and implantation efficiency can be reliably improved.

[0080] In one specific embodiment, reference continues to... Figures 2 to 5 The receiving mechanism 1 may include a second receiving portion 12, which is configured to receive a redundant section of the electrode 3. The redundant section refers to the section that naturally falls out after the electrode wire 31 (e.g., a flexible electrode wire) is pre-connected to the implantation needle 21, that is, the section located between the distal and proximal ends and exposed to the outside.

[0081] refer to Figure 4 and Figure 5 The redundant section of the electrode wire 31 is folded and accommodated within the second receiving portion 12. This folding configuration may include multiple U-shaped bends 311 arranged sequentially along the length of the second receiving portion 12, with adjacent U-shaped bends 311 having opposite opening directions. For example, refer to... Figure 5 Adjacent U-shaped bends 311 can open towards each other.

[0082] Furthermore, the redundant section is folded and housed within the second accommodating portion 12, which can be formed under conditions where a liquid medium is present within the second accommodating portion 12. The liquid medium can be, for example, pure water or physiological saline.

[0083] Furthermore, the electrode wire 31 can be configured such that when the distal end of the electrode wire 31 is pulled in the distal direction, the electrode wire 31 can be gradually released from the second receiving portion 12 and extend in a generally straight line. During implantation, the implantation needle 21, which has reached the corresponding preparatory position, moves along the first direction D1 under the driving force applied by the implantation rod 511. The distal end of the electrode wire 31 attached to the first end 21A is pulled by the implantation needle 21 and moves synchronously along the first direction D1. As the implantation needle 21 moves, each U-shaped bend 311 is pulled out of the second receiving portion 12 one by one, and the redundant section of the electrode wire 31 is gradually pulled out from the folded state stored in the second receiving portion 12 and extended in a generally straight line.

[0084] In some embodiments, the second receiving portion 12 may include a second body portion 121. The second body portion 121 may be integrally formed on the first receiving portion 11. For example, the end of the first receiving portion 11 away from the second segment 1Ab is formed with the first body portion 114 and the second body portion 121 respectively, opposite to each other, adjacent to each other, or staggered in a plane perpendicular to the first direction D1. The second body portion 121 is closer to the interior of the base 1A (e.g., the axis of rotation of the first receiving portion 11) than the first body portion 114. In the first direction D1, the first body portion 114 is closer to the mating body portion 115 than the second body portion 121. In other words, the second body portion 121 protrudes downward from the first body portion 114 to accommodate the first end 21A of the implantation needle 21 exiting the receiving hole 111. This reduces the length of the electrode wire 31 exposed outside and accommodates as much redundant segment as possible in the second receiving portion 12.

[0085] Furthermore, at least one receiving slot 122 may be formed on the second main body 121, and the redundant section is accommodated within the receiving slot 122. Multiple receiving slots 122 are arranged at intervals along the arrangement direction of the multiple implantation needles 21. Each receiving slot 122 corresponds one-to-one with a single implantation needle 21. Alternatively, multiple implantation needles 21 may correspond to the same receiving slot 122. Furthermore, the receiving slot 122 is open towards at least one side of the second main body 121. For example, the receiving slot 122 is open towards the first direction D1 and towards the first main body 114. The portion of the redundant section of the electrode wire 31 closest to its proximal end enters the receiving slot 122 through the opening of the receiving slot 122 towards the first direction D1. After reciprocating U-shaped bends along the first direction D1 and its opposite direction within the receiving slot 122 to form a multi-layered folded structure, the portion closest to its distal end exits the receiving slot 122 through the opening of the receiving slot 122 towards the first main body 114. Thus, the portion of the redundant section closest to the proximal end and the portion closest to the distal end each reach the first end 21A of the signal collector / stimulator body 32 and the implantation needle 21 with the shortest distance.

[0086] The receiving tank 122 can be filled with a liquid medium, which is beneficial for maintaining or releasing the folded shape of the redundant sections. For example, the liquid medium can prevent electrostatic adsorption, reduce friction, and maintain the orderly folding by utilizing surface tension.

[0087] Furthermore, the second receiving portion 12 may also include a constraint cover 123 for constraining the redundant section from one side. For example, continuing to refer to Figure 5 A constraint cap 123 is detachably disposed on the side of the second main body 121 facing the first main body 114 to close the opening of the receiving groove 122 facing the first main body 114. The opening of the receiving groove 122 facing the first direction D1 is always open, and the size of this opening is significantly smaller than the size of the opening closed by the constraint cap 123, preventing the redundant segment from unexpectedly falling off the receiving groove 122. During implantation, the redundant segment, which is pulled along the first direction D1, is gradually released from the opening of the receiving groove 122 facing the first direction D1.

[0088] In one variation, one of the second main body portion 121 and the constraint cover 123 may be disposed on the base 1A, such as in the first section 1Aa, while the other may be disposed on the first receiving portion 11. Alternatively, both the second main body portion 121 and the constraint cover 123 may be disposed on the first section 1Aa.

[0089] Therefore, this solution additionally provides a second receiving part 12 on the receiving mechanism 1, which does not interfere with the first receiving part 11. The redundant sections of the electrode wire 31 are reliably and independently housed in the second receiving part 12, preventing the redundant sections of adjacent electrode wires 31 from becoming entangled due to uncontrolled scattering, and also helping to prevent the redundant sections from interfering with the movement of the implantation needle 21 and / or the first receiving part 11. Thus, the problem of uncontrolled scattering of the redundant parts of the electrode wire 31 can be reliably addressed, ensuring successful implantation of the electrode wire 31 without affecting its implantation depth, while simultaneously guaranteeing success rate and implantation efficiency.

[0090] In one specific embodiment, reference Figure 6 and Figure 7 The implantation needle 21 may include a needle body 211 and a tungsten needle assembly 212 located at the end of the needle body 211 along a first direction D1. The end of the tungsten needle assembly 212 away from the needle body 211 is adapted to form a first end 21A, and the distal end of the electrode wire 31 is attached to the end of the tungsten needle assembly 212 away from the needle body 211 (i.e., the needle tip of the tungsten needle assembly 212). The end of the needle body 211 away from the tungsten needle assembly 212 is adapted to form a second end 21B, and the implantation rod 511 applies a driving force to the end of the needle body 211 away from the tungsten needle assembly 212.

[0091] Specifically, the needle body 211 may include a central tube 2111, which has a hollow structure and contains a solid shaft 2113. The ends of the central tube 2111 and / or the solid shaft 2113 away from the tungsten needle assembly 212 are adapted to form a second end 21B. The solid shaft 2113 is fixedly connected to the tungsten needle assembly 212, and the central tube 2111 is fixedly connected to the solid shaft 2113. Furthermore, the central tube 2111 may also be fixedly connected to the tungsten needle assembly 212. That is, the solid shaft 2113 and the tungsten needle assembly 212 are not only fixedly connected to each other, but also fixedly connected to the central tube 2111 inside the central tube 2111. The central tube 2111, the tungsten needle assembly 212, and the solid shaft 2113 can be relatively fixedly connected by means of bonding, welding, threaded connection, or snap-fit, especially in a series fixed connection in a center-aligned manner. In this design, the central tube 2111 and the solid shaft 2113 are designed as separate nested structures for easy processing.

[0092] Furthermore, the needle body 211 may also include an outer sleeve 2112, which has a hollow structure and is fitted onto the central tube 2111. The central tube 2111 can reciprocate within the outer sleeve 2112 along a first direction D1. Figure 2 and Figure 6The extension length of the outer tube 2112 is shorter than the extension length of the central tube 2111. The central tube 2111 extends along its length across the first segment 1Aa and the second segment 1Ab, while the outer tube 2112 extends mainly along the first segment 1Aa. The outer tube 2112 is located in the first receiving portion 11, and its two ends along the extension direction are respectively constrained by the first main body portion 114 and the mating main body portion 115.

[0093] In one variation, the central tube 2111 itself can be a solid structure; in other words, the central tube 2111 and the solid shaft 2113 can be integrated into a single unit. For example, the central tube 2111 can be directly and fixedly connected to the tungsten needle assembly 212 carrying the electrode wire 31. Furthermore, a blind hole can be formed at the end of the central tube 2111 away from the second end 21B, and the tungsten needle assembly 212 can be inserted into the blind hole and fixedly connected.

[0094] In some embodiments, the extension length of the solid shaft 2113 may be slightly shorter than the extension length of the central tube 2111, with the central tube 2111 protruding forward from the solid shaft 2113, particularly on the side near the first end 21A. Thus, the difference in length between the central tube 2111 and the solid shaft 2113 allows the two, which are nested as a single unit, to fit together at one end near the tungsten needle assembly 212 to form a structure similar to the aforementioned blind hole, facilitating the installation and fixation of the tungsten needle structure 212.

[0095] In some embodiments, the tungsten needle assembly 212 may be made of metallic tungsten.

[0096] In some embodiments, the solid central tube 2111 or the solid shaft 2113 may be made of stainless steel.

[0097] In some embodiments, the implantation needle 21 may further include an elastic structure 213, which is sleeved on the central tube 2111 and located inside the outer tube 2112. For example, the elastic structure 213 may include a spring constrained between the central tube 2111 and the outer tube 2112. The elastic deformation direction of the elastic structure 213 may be parallel to the first direction D1. Thus, the implantation needle 21 may also be referred to as a spring needle, which enables the implantation of the electrode wire 31 and its own repositioning.

[0098] Furthermore, the implantation needle 21 may also include a limiting ring 214 located on the outer surface of the central tube 2111. The limiting ring 214 is circumferentially clamped onto at least a portion of the outer surface of the central tube 2111. The limiting ring 214 can be fixedly connected to the central tube 2111. For example, the limiting ring 214 can be laser-welded to the central tube 2111. Another example is that the limiting ring 214 and the central tube 2111 can be interference-fitted. The inner diameter of the limiting ring 214 is interference-fitted with the outer diameter of the central tube 2111, thereby achieving a reliable fixed connection between the two. Yet another example is that the limiting ring 214 and the central tube 2111 can be integrally formed.

[0099] The limiting ring 214 is configured to cooperate with the elastic structure 213 so that the elastic structure 213 can accumulate a restoring force during the movement of the central tube 2111 (and solid shaft 2113) relative to the outer tube 2112 under the action of the driving force, and drive the central tube 2111 (and solid shaft 2113) to return to the original position based on the restoring force after the driving force is removed.

[0100] In some embodiments, the two ends of the elastic structure 213 along the elastic deformation direction can respectively abut against the lower end of the outer sleeve 2112 along the first direction D1 and the limiting ring 214. Thus, repositioning is achieved by the compression deformation of the elastic structure 213. For example, by applying a driving force to the central tube 2111 (and solid shaft 2113) of the implantation needle 21 through the implantation rod 511, the central tube 2111 (and solid shaft 2113) moves along the first direction D1 to implant the electrode wire 31 into the biological tissue. During this process, the elastic structure 213 is subjected to axial (i.e., first direction D1) compressive force. After the implantation operation is completed, by slowly releasing the central tube 2111 (and solid shaft 2113), the elastic structure 213 can automatically reposition itself under its own restoring force, thereby allowing the central tube 2111 (and solid shaft 2113) to automatically reposition itself.

[0101] In one variation, the two ends of the elastic structure 213 along the elastic deformation direction can be fixedly connected to the limiting ring 214 and the upper end of the outer sleeve 2112 along the first direction D1, respectively. Thus, repositioning is achieved by utilizing the tensile deformation of the elastic structure 213. For example, by applying a driving force to the central tube 2111 (and solid shaft 2113) of the implantation needle 21 through the implantation rod 511, the central tube 2111 (and solid shaft 2113) moves along the first direction D1 to implant the electrode wire 31 into the biological tissue. During this process, the elastic structure 213 is subjected to an axial (i.e., first direction D1) tensile force. After the implantation operation is completed, by slowly releasing the central tube 2111 (and solid shaft 2113), the elastic structure 213 can automatically reposition itself under its own restoring force, thereby allowing the central tube 2111 (and solid shaft 2113) to automatically reposition itself.

[0102] In some embodiments, continue to refer to Figure 6 and Figure 7 The implantation needle 21 may also include a pair of plugs 215, which are respectively disposed at both ends of the outer tube 2112 along the extension direction and fixedly connected to the corresponding ends.

[0103] Furthermore, a restrictive through hole can be provided on the plug 215. This restrictive through hole is configured to allow the central tube 2111 (and the solid shaft 2113) to pass through, but not to allow the limiting ring 214 to pass through. In this solution, the maximum travel of the central tube 2111 (and the solid shaft 2113) relative to the outer tube 2112 along the first direction D1 and its opposite direction is limited by the cooperation of the limiting ring 214 and the plug 215, thereby preventing the central tube 2111 (and the solid shaft 2113) from unexpectedly falling out of the outer tube 2112.

[0104] In one specific embodiment, reference Figures 2 to 5 and Figure 8 The accommodating mechanism 1 may further include a third accommodating portion 13 independent of the first accommodating portion 11. The accommodating spaces formed by the first accommodating portion 11 and the third accommodating portion 13 may be arranged opposite to each other. In some embodiments, the opposite sides of the base 1A are adapted to form the first accommodating portion 11 and the third accommodating portion 13, respectively. For example, in a plane perpendicular to the first direction D1, the first segment 1Aa has opposite sides, one side of which is adapted to form or mount the first accommodating portion 11, and the other side can be used to form the third accommodating portion 13. In some embodiments, the first accommodating portion 11 and the third accommodating portion 13 may be integrally formed.

[0105] Furthermore, the third receiving portion 13 can be used to accommodate the signal acquisition / stimulator body 32. For example, the signal acquisition / stimulator body 32 is detachably disposed in the third receiving portion 13. For example, during implantation, the signal acquisition / stimulator body 32 can be fixed to the third receiving portion 13. After implantation, the signal acquisition / stimulator body 32 can be removed from the third receiving portion 13 and installed in the organism to which the electrode wire 31 has been implanted.

[0106] Therefore, the implantation component 2 and the signal acquisition / stimulator can be integrated simultaneously on the receiving mechanism 1 without interference. The signal acquisition / stimulator includes a signal acquisition / stimulator body 32 and an electrode 3. Both the electrode 3 and the signal acquisition / stimulator body 32 are housed in the receiving mechanism 1 and can move as a whole. During the implantation operation, the operator can move the implantation device 100A at will without pulling on the electrode 3, causing it to break or unexpectedly fall off from the implantation needle 21.

[0107] Furthermore, the first receiving portion 11 and the third receiving portion 13 can be integrated into the same structure (i.e., the base 1A), so that the relative positions of the implantation component 2 and the signal acquisition / stimulator body 32, which are respectively housed in these two structures, can be kept fixed. Thus, both the implantation needle 21 and the electrode wire 31 to be implanted can enter the ready state for implantation.

[0108] In some embodiments, continue to refer to Figure 3 and Figure 8 The third receiving portion 13 may include a third main body portion 131, which has a receiving space to receive the signal acquisition / stimulator body 32. Figure 8 The structure of base 1A without the signal acquisition / stimulator body 32 is shown as an example, with a focus on the structure of the area where the third receiving part 13 is located.

[0109] Specifically, a third main body portion 131 is formed on the side of the first section 1Aa away from the first receiving portion 11. The first section 1Aa is generally plate-shaped and protrudes at its end along the first direction D1 towards the side away from the first receiving portion 11 to form a protrusion. The protrusion and the large surface of the first section 1Aa together form a receiving space that opens towards the side away from the first receiving portion 11.

[0110] The third main body 131 may be provided with a slot structure that resembles the outer contour shape of the signal acquisition / stimulator body 32. For example, if the outer contour of the signal acquisition / stimulator body 32 is circular, the third main body 131 may be provided with a circular slot. The signal acquisition / stimulator body 32 may be accommodated within this circular slot.

[0111] Furthermore, the third receiving portion 13 may also include a retaining structure 132, through which the signal acquisition / stimulator body 32 is detachably connected to the third body portion 131. The retaining structure 132 may be disposed in the first segment 1Aa. Along the first direction D1, the retaining structure 132 may be located between the third body portion 131 and the second segment 1Ab.

[0112] In some embodiments, the retaining structure 132 may include: a clamping portion 1321, which is movable relative to the third body portion 131; and a retaining mechanism 1322, which is used to hold the clamping portion 1321 in a first position, wherein the clamping portion 1321 in the first position is adapted to fix the signal acquisition / stimulator body 32 to the third body portion 131.

[0113] For example, the clamping part 1321 may include a push button, and the holding mechanism 1322 may include a spring. The push button may be provided with a spring mounting hole and a sliding support structure, so that the push button can slide in the groove 15 of the first section 1Aa. The groove 15 may extend along a first direction D1, and the push button may move along the groove 15 in a direction away from or towards the third body part 131. The two ends of the spring along the elastic deformation direction abut against the end of the first section 1Aa near the second section 1Ab and the spring mounting hole, respectively. When no external force is applied, the spring applies a holding force toward the third body part 131 to hold the push button in the first position.

[0114] Furthermore, the retaining structure 132 may also include an operating part 1323 for triggering movement of the clamping part 1321 relative to the third body part 131 to release or clamp the signal acquisition / stimulator body 32. For example, the end of the push button along the direction of movement may protrude outward to form a protrusion adapted to form the operating part 1323. The operator's finger can push outward or retract the protrusion to operate the push button.

[0115] Furthermore, the retaining structure 132 may also include a push-button cover 1324, which is fixed to the first section 1Aa by a fastener 1325. A through groove 1326 extending along a first direction D1 may be provided on the push-button cover 1324. This through groove 1326 extends through the push-button cover 1324 in the direction from the third receiving portion 13 to the first receiving portion 11. The through groove 1326 is open on the side facing the third main body portion 131. The push button at least partially passes through the through groove 1326 and extends into the slide groove 15. Thus, the push-button cover 1324, together with the slide groove 15, can act as a guide and limiter, guiding the push button to move smoothly along the first direction D1 relative to the third main body portion 131. The fastener 1325 may be, for example, a screw.

[0116] In one specific embodiment, reference continues to... Figure 2 The implantation device 100A may also include a housing 4, which is detachably connected to the first receiving portion 11 to cover at least a portion of the structure of the implantation assembly 2. For example, the housing 4 covers at least the first receiving portion 11 and the portion of the implantation needle 21 that extends beyond the receiving hole 111.

[0117] Furthermore, the housing 4 may have an observation window 41, through which the connection area between the implantation component 2 and the electrode 3 is visible. The observation window 41 can be used to observe the connection status between the electrode wire 31 and the corresponding implantation needle 21. For example, the operator can observe through the observation window 41 whether the electrode wire 31 is pre-connected to the implantation needle 21, whether the electrode wire 31 has detached from the implantation needle 21, or whether the electrode wire 31 is entangled with the implantation needle 21, without exposing the connection area between the implantation needle 21 and the electrode 3.

[0118] Thus, by detachably providing a cover 4 on at least a portion of the outer periphery of the implantation device 100A, the electrode wire 31 and the tungsten needle assembly 212 can be protected from impact damage.

[0119] In some embodiments, the material of the housing 4 may be medical-grade polyetheretherketone (PEEK).

[0120] Next, combine Figures 9 to 13 The specific structure of the microelectrode driver 100B is described in detail.

[0121] Specifically, the microelectrode driver 100B may include a drive mechanism 5, which is used to move the electrode 3 to a target position. The drive mechanism 5 may be drively connected to the implantation needle 21 carrying the electrode 3. In this embodiment, the drive mechanism 5 drives the implantation needle 21 to move, thereby moving the electrode 3 to the target position. Furthermore, the drive mechanism 5 is adapted to control the movement of the implantation needle 21 in three-dimensional space to precisely move the electrode 3 to the target position.

[0122] In this solution, the drive mechanism 5 precisely and quickly moves the electrode 3 to the target position, achieving efficient and high-precision implantation of the electrode 3. The drive mechanism 5 is connected to the implantation needle 21 attached to the electrode 3 to ensure reliable transmission of driving force. Under the driving force applied by the drive mechanism 5, the implantation needle 21 moves to the target position to implant the electrode 3 into that target position.

[0123] In one specific embodiment, reference continues to... Figures 9 to 12 The drive mechanism 5 may include a first drive shaft 51. The first drive shaft 51 is used to drive the implantation needle 21 to move along a first direction D1. The direction of the axial driving force provided by the first drive shaft 51 is aligned with the axial direction of the implantation needle 21. Based on the axial driving force provided by the first drive shaft 51 to the implantation needle 21, the implantation of the electrode wire 31 can be realized.

[0124] Specifically, the first drive shaft 51 may include an implantation rod 511. During implantation, the implantation rod 511 is held above the target position. The implantation rod 511 moves along a first direction D1, and the third end 511A of the implantation rod 511 engages with the second end 21B of the implantation needle 21 to trigger and / or control the movement of the implantation needle 21 in the first direction D1.

[0125] Furthermore, the first drive shaft 51 may also include an implantation shaft 512. The implantation shaft 512 is fixedly connected to the implantation rod 511. The implantation shaft 512 may include a motor for providing a driving force along the first direction D1 to drive the implantation rod 511 to move synchronously, thereby triggering and / or controlling the corresponding movement of the implantation needle 211. In this solution, the linear movement of the implantation rod 511 driven by the implantation shaft 512 provides axial driving force for the implantation of the electrode wire 31. In some embodiments, encoder feedback can be used to achieve precise control of the implantation stroke, avoiding brain tissue damage due to excessive stroke or insufficient implantation depth of the electrode wire 31 due to insufficient stroke.

[0126] In some embodiments, the implantation rod 511 may include a push rod cap 5111, which is disposed on the output shaft of the implantation shaft 512. In a plane perpendicular to the first direction D1, the push rod cap 5111 protrudes outward to form an actuating mechanism 513. The push rod cap 5111 and the implantation shaft 512 can be fixedly connected by welding, gluing, screws, or other methods. In this embodiment, the push rod cap 5111 serves as a power transmission intermediary between the implantation shaft 512 and the implantation needle 21, enabling the smooth transmission of the linear driving force output by the implantation shaft 512 to the solid shaft 2113 of the implantation needle 21.

[0127] Furthermore, the implantation rod 511 may also include a guide post 5112 extending from the push rod cap 5111 in a direction away from the third end 511A. The guide post 5112 extends from the push rod cap 5111 along the outer surface of the implantation shaft 512. The extension direction of the guide post 5112 is parallel to the first direction D1. The extension length of the guide post 5112 may be at least half the extension length of the implantation shaft 512. In some embodiments, in a plane perpendicular to the first direction D1, the actuation mechanism 513 and the guide post 5112 are located on opposite sides of the push rod cap 5111.

[0128] The microelectrode driver 100B may include a cap 52. The cap 52 is disposed on the outer surface of the implantation rod 511 and has a receiving channel 521 extending along a first direction D1. Further, the receiving channel 521 is open on one side of the cap 52 along the first direction D1, and the implantation rod 511 is at least partially received within the receiving channel 521 and is movable along the receiving channel 521.

[0129] For example, the pressure cap 52 is positioned on the side where the guide post 5112 is located; that is, the guide post 5112 is located between the pressure cap 52 and the implantation shaft 512. The receiving channel 521 is at least adapted to accommodate the guide post 5112. During the overall movement of the implantation rod 511 under the power support of the implantation shaft 512, the guide post 5112 moves along the receiving channel 521. The extending direction of the receiving channel 521 may be parallel to the first direction D1 to guide and limit the guide post 5112. This ensures that the implantation rod 511 always moves smoothly along the first direction D1. The pressure cap 52 provides spatial protection for the first drive shaft 51.

[0130] In some embodiments, the push cap 5111 may always be located outside the receiving channel 521. For example, refer to Figure 10 Most of the structure of the implant rod 511 is covered by the cap 52, with only part of the structure of the push rod cap 5111, especially the trigger mechanism 513, exposed.

[0131] In other embodiments, the implantation rod 511 can be entirely within the coverage area of ​​the pressure cap 52 when not driven by the implantation shaft 512. This is beneficial for better protection of the implantation rod 511 from accidental damage.

[0132] In one specific embodiment, reference continues to... Figures 9 to 11 The drive mechanism 5 may include a second drive shaft 53. The second drive shaft 53 is used to drive the implantation needle 21 to move in a plane perpendicular to the first direction D1.

[0133] Specifically, the second drive shaft 53 can be fixedly connected to the first receiving portion 11. Under the driving force of the second drive shaft 53, the first receiving portion 11 can translate or rotate to move the multiple implantation needles 21 one by one to the corresponding preparatory positions. The corresponding preparatory position is located above the target position. The first drive shaft controls and / or triggers the movement of the implantation needle 21 currently located at the corresponding preparatory position along the first direction D1 to implant the electrode wire 31 carried by the implantation needle 21 into the target position.

[0134] For example, refer to Figure 11 The second drive shaft 53 may include a rotating shaft 531. The rotating shaft 531 can drive the first accommodating portion 11 to rotate in a plane perpendicular to the first direction D1. Specifically, the end of the base 1A opposite to the first direction D1 extends outward to form a receiving shaft 16. The rotating shaft 531 is mated with and locked to the receiving shaft 16 by a locking structure 54. Rotation of the output shaft of the rotating shaft 531 can drive the receiving shaft 16, which is locked to it, to rotate, thereby driving the first accommodating portion 11 integrated into the base 1A to rotate synchronously.

[0135] For example, the second drive shaft 53 may include a translation shaft (not shown). The translation shaft can drive the first receiving portion 11 to translate in a plane perpendicular to the first direction D1.

[0136] Therefore, the driving of the implantation needle 21 can be decomposed into two dimensions: along the first direction D1 and perpendicular to the first direction D1, and driven by independent drive shafts respectively. For example, the implantation needle 21 is driven to move along the first direction D1 based on the first drive shaft 51 (e.g., implantation shaft 512), and the first receiving part 11 that houses the implantation needle 21 is driven to move in a plane perpendicular to the first direction D1 based on the second drive shaft 53 (e.g., rotation axis 531 or translation axis). The first receiving part 11 can accommodate multiple implantation needles 21, which can move sequentially under the drive of the drive mechanism 5 to implant the electrodes 3 they carry into the target position. During the implantation process, after driving one implantation needle 21 to move downward along the first direction D1 to reach the target position, driving the first receiving part 11 to rotate or translate as a whole can align the next implantation needle 21 with the target position, and then driving the next implantation needle 21 to move along the first direction D1 to reach the target position. In this solution, the second drive shaft 53 enables rapid needle replacement, and the first drive shaft 51 enables reliable movement of each implantation needle 21 along the first direction D1, so as to ensure accurate implantation of the electrode 3.

[0137] In one specific embodiment, reference continues to... Figure 10 and Figure 11 The microelectrode driver 100B may include a fourth main body portion 6. The fourth main body portion 6 is used to house the drive mechanism 5. Specifically, the fourth main body portion 6 may include a first plate portion 61 and a second plate portion 62 that are intersecting. The first plate portion 61 extends parallel to a first direction D1, and the second plate portion 62 extends perpendicular to the first direction D1. The first plate portion 61 may be located on one side of the second plate portion 62. In some embodiments, the first plate portion 61 and the second plate portion 62 may be integrally formed, that is, the fourth main body portion 6 is a single piece. In some embodiments, the first plate portion 61 and the second plate portion 62 may be fixed together by a fixing structure such as screws.

[0138] Furthermore, the first drive shaft 51 and the second drive shaft 53 can be respectively disposed on opposite sides of the fourth main body 6. The microelectrode driver 100B can accommodate the first drive shaft 51 and the second drive shaft 53 in an integrated manner through the fourth main body 6. Thus, the relative positions of the two drive shafts are fixed and do not interfere with each other, ensuring that the axial driving force provided by the first drive shaft 51 can be reliably transmitted to the implantation needle 21 accommodated on the first receiving part 11 which is fixed relative to the second drive shaft 53.

[0139] In some embodiments, the first drive shaft 51 may be disposed on the side of the first plate portion 61 opposite to the second plate portion 62. Specifically, a fixing groove 611 is provided on the side of the first plate portion 61 opposite to the second plate portion 62. The first drive shaft 51 is fixed to the fixing groove 611. For example, the implantation shaft 512 is embedded in the fixing groove 611 with the side opposite to the guide post 5112 facing the fixing groove 611. A baffle 612 may be provided at one end of the fixing groove 611 along the extending direction. The baffle 612 is adapted to limit the maximum travel of the implantation shaft 512 in the opposite direction of the first direction D1.

[0140] In some embodiments, the second drive shaft 52 may be disposed on the second plate portion 62. For example, the second plate portion 62 may have a through hole 621. The output shaft of the rotating shaft 531 can pass through the through hole 621 and be locked to the receiving shaft 16 on one side of the second plate portion 62 along the first direction D1 via a locking structure 54.

[0141] In one specific embodiment, reference continues to... Figure 10 and Figure 11 The microelectrode actuator 100B may include a three-dimensional motion axis 7. The three-dimensional motion axis 7 can drive the drive mechanism 5 to move within a three-dimensional plane. In this design, the three-dimensional motion axis 7 enables the microelectrode actuator 100B to move freely in three directions, thus ensuring that the microelectrode actuator 100B has at least three degrees of freedom of movement. Furthermore, the drive mechanism 5, driven by the three-dimensional motion axis 7, can achieve millimeter- to centimeter-level spatial movement within a three-dimensional plane, with micrometer-level stepping accuracy. For example, the linear stroke can reach 1 mm to 50 mm, and the minimum stepping resolution can reach 0.1 mm. Therefore, precise displacement control of the microelectrode actuator 100B can be achieved.

[0142] In some embodiments, the motion coordination control of the three-dimensional motion axis 7 and the second drive axis 53 can be achieved by controlling the microelectrode driver 100B. For example, the implantation action is automatically initiated after the second drive axis 53 completes the needle replacement.

[0143] In this solution, for example, the first drive shaft 51 can be mounted on the fourth main body 6 to achieve coordinated motion control of the three-dimensional motion axis 7, the second drive shaft 52, and the first drive shaft 51, thereby realizing integrated automatic control of implantation position adjustment, needle replacement, and implantation action. This enables automatic motion control of the implantation action in five motion dimensions.

[0144] In one specific embodiment, reference continues to... Figure 11 and Figure 13The microelectrode driver 100B may include a calibration mechanism 8. The calibration mechanism 8 is used to calibrate the initial position of the implantation needle 21 so that the initial position is aligned with the target position. The initial position refers to the position of the first end 21A when the implantation needle 21 is initially installed into the first receiving portion 11. In some embodiments, through the cooperation of the receiving shaft 16, the second drive shaft 53, and the locking structure 54, the implantation device 100A can be detachably connected to the microelectrode driver 100B, and multiple implantation needles 21 are pre-accommodated in the first receiving portion 11 before the implantation device 100A is connected to the microelectrode driver 100B. Accordingly, the initial position described in this embodiment refers to the position of the first implantation needle 21 to be implanted among the multiple implantation needles 21 when the implantation device 100A is initially connected to the microelectrode driver 100B. It can be understood that the initial position is the corresponding pre-position of the first implantation needle 21 to be implanted.

[0145] In some embodiments, the calibration mechanism 8 may include a pair of laser emitters 81. The pair of laser emitters 81 emit laser beams 811 at an angle, and the intersection of the two laser beams 811 is used to indicate the target position of the electrode 3. Furthermore, the travel distance between the initial position and the target position can be visually determined by observing the travel distance between the intersection of the pair of laser beams 811 and the current position of the tip of the implantation needle 21 to be implanted. The operator can move the position of the microelectrode driver 100B by controlling the three-dimensional motion axis 7, so that the implantation needle 21 carried on the implantation device 100A connected to it gradually approaches the target position until the intersection of the pair of laser beams 811 coincides with the target implantation site on the biological tissue.

[0146] Specifically, refer to Figure 13 A pair of receiving slots 63 may be provided on the fourth main body 6. The receiving slots 63 extend at an angle relative to the first direction D1 and are used to receive the laser emitters 81. The fourth main body 6 can provide fixed support for the calibration mechanism 8. The pair of receiving slots 63 extending in a specific direction can achieve specific beam convergence and positioning, that is, ensure that the pair of laser beams 811 emitted by the pair of laser emitters 81 can intersect at the target position.

[0147] Furthermore, the pair of receiving grooves 63 are spatially symmetrical with respect to the axial central axis of the implantation needle 21. The intersection of the extension directions of the pair of receiving grooves 63 intersects the axial central axis of the implantation needle 21 at the target location.

[0148] The receiving groove 63 can be formed on the fourth main body 6 by machining a part. For example, see reference. Figure 11 and Figure 13The receiving groove 63 is disposed on the side of the first plate portion 61 facing the second plate portion 62. Furthermore, the receiving groove 63 is located below the second plate portion 62. After the implantation device 100A is mounted onto the microelectrode driver 100B, a pair of laser emitters 81 are substantially above the implantation assembly 2 and substantially directly above the implantation needle 21.

[0149] During the calibration process before the actual implantation of electrode wire 31, the movement of drive mechanism 5 in the first direction D1 and its opposite direction is adjusted by the three-dimensional motion axis 7, so that the intersection point of a pair of laser beams 811 falls on the target position on the central axis of the first implantation needle 21 to be implanted. Specifically, during the design, installation and debugging process, the axial angle and installation position of a pair of laser emitters 81 are preset and fixed by designing the position and tilt extension angle of a pair of receiving slots 63, and the pair of laser beams 811 intersect at a point, i.e., the convergence point, which corresponds to the target implantation site (i.e., the target position). The implantation needle 21 to be implanted is placed at a preset starting point (i.e., the initial position). The axial central axis of the implantation needle 21 to be implanted is consistent with its implantation direction, and both the preset starting point and the target implantation site are located in this implantation direction.

[0150] During installation and debugging, firstly, a preset distance is established between the preset starting point and the target implantation site. This preset distance is, for example, between 10mm and 50mm, preferably 25mm or 30mm. Then, by manually adjusting the position of the three-dimensional motion axis 7 in three dimensions, the convergence point of a pair of laser beams 811 is gradually brought closer to the target implantation site until the convergence point coincides with the target implantation site. The position of the implantation needle 21 to be implanted at this point is the preset starting point. When the convergence point completely coincides with the target implantation site, the installation and debugging are completed. When adjusting the three-dimensional motion axis 7, it is preferable to adjust the Z-axis first, and then adjust the X-axis and Y-axis. The Z-axis is parallel to the first direction D1, and the X-axis and Y-axis are perpendicular to the first direction D1 and are also perpendicular to each other.

[0151] Thus, with the aid of the calibration mechanism 8, precise alignment of the implantation needle 21 with the implantation site (i.e., the target site) and precise navigation of the tip of the implantation needle 21 toward the implantation site can be achieved. The calibration mechanism 8 preferably provides precise positioning and navigation based on laser emitters 81. On the one hand, this enables the entire implantation system 100 to achieve precise positioning relative to the implanted object (e.g., neural tissue, such as animal brain tissue). On the other hand, it enables the implantation needle 21 to achieve precise navigation relative to the ideal implantation site (i.e., the target site), and can accurately detect the distance between the tip of the implantation needle 21 (which is pre-connected to the electrode wire 31 to be implanted) and the ideal implantation point. Furthermore, a pair of laser emitters 81 can also be used to achieve precise positional navigation of the implantation needle 21 relative to the implanted object. Laser navigation positioning greatly reduces the difficulty of implantation and significantly improves the efficiency of finding the implantation point, i.e., the positioning efficiency of the implantation point.

[0152] In some embodiments, the microelectrode driver 100B can be detachably connected to the fixed platform 100C via a quick-release structure 9. In this design, the quick-release structure 9 makes the connection between the microelectrode driver 100B and the fixed platform 100C not only robust and reliable but also flexible and adaptable. Quick-release replacement can be achieved when needed.

[0153] In some embodiments, by rotating at a specific angle using a rotary motor mounted on the microelectrode driver 100B, rapid rotational needle changing for different implantation needles 21 on the implantation device 100 can be achieved, thereby enabling rapid and efficient implantation of multiple electrode wires 31.

[0154] In some embodiments, by performing a translational action with a specific displacement by a linear motor disposed on the microelectrode driver 100B, it is possible to quickly translate and change different implantation needles 21 on the implantation device 100, thereby enabling rapid and efficient implantation of multiple electrode wires 31.

[0155] While the above disclosure is provided, it is not limited thereto. Any person skilled in the art may make various alterations and modifications without departing from the spirit and scope of this disclosure; therefore, the scope of protection of this disclosure shall be determined by the scope defined in the claims.

Claims

1. An implant device, characterized in that, The implant device comprises: a housing mechanism comprising a first housing portion; an implant assembly accommodated in the first housing portion, at least part of the structure of the implant assembly being movable relative to the first housing portion to drive movement of an electrode attached to the implant assembly; wherein the electrode is capable of collecting electrical signals of biological tissue or applying electrical stimulation to biological tissue.

2. The implant device of claim 1, wherein, The implant assembly comprises a plurality of implant needles, each of the implant needles extends along a first direction and has opposite first and second ends, the electrode is attached to the first end, and the second end is configured to receive a driving force along the first direction, the driving force being capable of triggering and / or controlling movement of the implant needle in the first direction.

3. The implant device of claim 2, wherein, A plurality of accommodation holes are formed on the first housing portion, the plurality of accommodation holes correspond to the plurality of implant needles one by one, and at least part of the implant needles are accommodated in the corresponding accommodation holes.

4. The implant device of claim 3, wherein, The first housing portion is capable of rotational or translational movement in a plane perpendicular to the first direction, and each of the plurality of accommodation holes is capable of moving to a corresponding standby position in sequence with the movement of the first housing portion, when the accommodation hole is in the corresponding standby position, the implant needle corresponding to the accommodation hole can be triggered and / or controlled by the driving force to move in the first direction.

5. The implant device of claim 3, wherein, The plurality of accommodation holes are distributed in a single row or multiple rows of accommodation holes in a plane perpendicular to the first direction.

6. The implant device of claim 5, wherein, When the plurality of accommodation holes are distributed in multiple rows of accommodation holes in a plane perpendicular to the first direction, the adjacent two rows of accommodation holes in the multiple rows of accommodation holes are staggered; and / or The multiple rows of accommodation holes are arranged in concentric circular arcs.

7. The implant device of claim 3, wherein, The second end of the implant needle is capable of receiving a driving force along the first direction from an implant rod, the implant rod has opposite third and fourth ends, and the third end is configured to cooperate with the second end to trigger and / or control movement of the implant needle in the first direction.

8. The implant device of claim 7, wherein, A triggering mechanism is arranged on the third end of the implant rod, and the triggering mechanism is configured to cooperate with the second end of the implant needle to trigger and / or control movement of the implant needle in the first direction.

9. The implant device of claim 8, wherein, The triggering mechanism is capable of being drivingly connected to the second end of the implant needle in a concave-convex cooperation or a surface contact manner, so that the force transmission direction between the triggering mechanism and the implant needle is aligned with the axial direction of the implant needle, and the force transmission direction is consistent with the first direction.

10. The implant device of claim 7, wherein, The first housing portion comprises: a first body portion, the plurality of accommodation holes are arranged through the first body portion along the first direction, and the first body portion has opposite first and second sides along the first direction, and the first side is closer to the third end of the implant rod than the second side.

11. The implant device of claim 10, wherein, The inner diameter of the accommodation hole is in interference fit with the outer diameter of the implant needle.

12. The implant device of claim 4, wherein, The rotational or translational movement is achieved by rotating the first housing portion by a predetermined angle or moving the first housing portion by a predetermined distance.

13. The implant device of claim 1, wherein, The housing mechanism further comprises a second housing portion configured to accommodate a redundant section of the electrode.

14. The implant device of claim 13, wherein, The electrode comprises a flexible electrode wire, and a redundant section of the flexible electrode wire is accommodated in the second accommodating portion in a folded manner, the folded manner comprising a plurality of U-shaped bending portions arranged in sequence along the length direction of the second accommodating portion, and adjacent U-shaped bending portions are opposite in opening direction; The redundant section is accommodated in the second accommodating portion in a folded manner under the condition that liquid medium exists in the second accommodating portion; The flexible electrode wire is configured to be gradually released from the second accommodating portion and extend in a substantially straight line when the distal end of the flexible electrode wire is pulled in the distal direction.

15. The implant device of claim 13, wherein, The second accommodating portion comprises: a second main body portion; at least one receiving groove opened to at least one side of the second main body portion, and the redundant section is accommodated in the receiving groove; a constraint cover for constraining the redundant section from one side.

16. The implant device of claim 2, wherein, The implant needle comprises a needle body and a tungsten needle assembly located at the end of the needle body in the first direction, and the end of the tungsten needle assembly away from the needle body is adapted to form the first end, and the end of the needle body away from the tungsten needle assembly is adapted to form the second end.

17. The implant device of claim 16, wherein, The needle body comprises: a center tube in a solid structure or provided with a solid shaft, and the center tube is fixedly connected with the tungsten needle assembly; an outer sleeve sleeved on the center tube, and the center tube can reciprocate in the outer sleeve along the first direction.

18. The implant device of claim 17, wherein, The implant needle further comprises an elastic structure sleeved on the center tube and located in the outer sleeve, and the elastic deformation direction of the elastic structure is parallel to the first direction; and a limiting ring located on the outer surface of the center tube; wherein the two ends of the elastic structure along the elastic deformation direction are respectively abutted on the lower end of the outer sleeve along the first direction and the limiting ring, or are fixedly connected on the limiting ring and the upper end of the outer sleeve along the first direction.

19. The implant device of claim 1, wherein, The accommodating mechanism comprises a third accommodating portion independent of the first accommodating portion, and the third accommodating portion is used to accommodate a signal collector / stimulator body coupled with the electrode.

20. The implant device of claim 19, wherein, The first accommodating portion and the third accommodating portion are integrally formed; and / or The accommodating spaces formed by the first accommodating portion and the third accommodating portion are arranged away from each other; and / or The accommodating mechanism comprises a base, and the two sides of the base away from each other are adapted to form the first accommodating portion and the third accommodating portion, respectively.

21. The implant device of claim 19, wherein, The third accommodating portion comprises: a third main body portion having an accommodating space to receive the signal collector / stimulator body; a retaining structure, and the signal collector / stimulator body is detachably retained in the third main body portion via the retaining structure.

22. The implant device of claim 21, wherein, The retaining structure comprises: a clamping portion movable relative to the third main body portion; a retaining mechanism for retaining the clamping portion in a first position, and the clamping portion in the first position is adapted to fix the signal collector / stimulator body to the third main body portion.

23. The implant device of claim 22, wherein, The holding structure further comprises an operation portion for triggering movement of the clamping portion relative to the third body portion to release or clamp the signal collector / stimulator body.

24. The implant device of claim 19, wherein, The electrode comprises a plurality of electrode wires, wherein each electrode wire has opposite fifth and sixth ends along an extension direction, the fifth end of the electrode wire is physically connected with the implant assembly, and the sixth end of the electrode wire is coupled with the signal collector / stimulator body.

25. The implant device of claim 1, wherein, The implant device further comprises a cover detachably connected to the first accommodating portion to cover at least part of the structure of the implant assembly.

26. The implant device of claim 25, wherein, The cover is provided with an observation window, and a connection area of the implant assembly and the electrode is visible externally via the observation window.

27. An implant system, characterized by The implant system comprises the implant device according to any one of claims 1 to 26.

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