Guiding device, implantation system and guiding method for flexible electrodes

Abstract

This disclosure discloses a guiding device, implantation system, and guiding method for flexible electrodes. The guiding device includes: a guiding needle comprising a needle body and a needle tip located at the front end of the needle body, a recess comprising opposing first and second side surfaces located near the front end of the needle body, wherein the first side surface is closer to the front end of the needle body, and a protrusion extending toward the first side surface and capable of passing through a through-hole of the flexible electrode; and a needle sheath having a hollow structure to provide a channel within the needle sheath allowing the guiding needle to move therethrough, a first opening at the front end of the needle sheath allowing the engagement portion of the flexible electrode to slide into the recess of the guiding needle via the first opening, and the protrusion of the guiding needle to pass through the through-hole of the flexible electrode to carry the flexible electrode. This disclosure utilizes the cooperation between the guiding needle and the needle sheath to facilitate the engagement and disengagement of the guiding needle and the flexible electrode, reducing the probability of damage to the flexible electrode and mechanical disturbance to biological tissue.

Description

Technical Field

[0001] This disclosure relates to the field of brain-computer interface technology, and more specifically, to a guiding device, implantation system and guiding method for flexible electrodes. Background Technology

[0002] Flexible electrodes, as an important emerging tool in the field of brain-computer interfaces, offer superior biocompatibility and long-term stability compared to traditional rigid electrodes, and are less prone to scarring in brain tissue. However, due to their inherent low mechanical strength and susceptibility to deformation, flexible electrodes are prone to breakage during implantation into brain tissue, making it difficult to directly penetrate the meninges and enter the brain tissue. Therefore, the implantation of flexible electrodes has always been a significant technical challenge in this field.

[0003] US11103695B2 discloses a system and method for implanting a device into biological tissue (e.g., brain tissue). US11103695B2 uses clamps to assist in the engagement of a needle with the receiving feature of a probe. Specifically, the clamps can grip the receiving feature of the probe against the needle to secure the probe to the needle, allowing the probe to enter the biological tissue along with the needle. The clamps can then detach the receiving feature of the probe from the needle and leave it in the target location, while allowing the needle to withdraw. This method relies on high-precision coordinated movement between the two independent components, the needle and the clamps; any deviation in control timing or position can lead to implantation failure. More importantly, after implantation, the clamps themselves need to detach from the probe and withdraw from the biological tissue. If these actions are performed in a confined space, they are highly susceptible to scraping or snagging with the already positioned probe, leading to probe twisting, displacement, or even breakage. Performing these actions in a larger space causes significant trauma to the biological tissue. In addition, the entire implantation process is complicated by the linkage of multiple components, which not only prolongs the operation time, but also increases the risk of unnecessary secondary damage to surrounding tissues due to excessive mechanical operation. Summary of the Invention

[0004] A brief overview of this disclosure is given below to provide a basic understanding of some aspects of it. However, it should be understood that this overview is not an exhaustive summary of this disclosure. It is not intended to identify key or essential parts of this disclosure, nor is it intended to limit the scope of this disclosure. Its purpose is merely to present certain concepts of this disclosure in a simplified form as a prelude to the more detailed description that follows.

[0005] The purpose of this disclosure is to provide a guiding device, implantation system, and guiding method for flexible electrodes to reduce damage to the flexible electrodes and biological tissues (e.g., brain tissue) during implantation.

[0006] According to a first aspect of this disclosure, a guiding device for a flexible electrode is provided, the flexible electrode having a joint including a through hole, the guiding device comprising: a guiding needle including a needle body and a needle tip located at a front end of the needle body, a recess provided on the needle body near the front end of the needle body, the recess including opposing first side surfaces and second side surfaces, the first side surface being closer to the front end of the needle body than the second side surface, the second side surface having a protrusion extending toward the first side surface, the protrusion being configured to pass through the through hole of the flexible electrode; and a needle sleeve having a hollow structure to provide a channel inside the needle sleeve, the channel being configured to allow the guiding needle to move therethrough, a first opening provided at the front end of the needle sleeve, the first opening being configured to allow the joint of the flexible electrode to slide into the recess of the guiding needle via the first opening, such that the protrusion of the guiding needle can pass through the through hole of the flexible electrode to carry the flexible electrode along with the guiding needle.

[0007] In some embodiments, the first opening includes a first portion spaced apart from the front surface of the needle sheath, the width of the first portion being greater than or equal to the width of the engagement portion of the flexible electrode.

[0008] In some embodiments, the first opening further includes a second portion communicating with the first portion of the first opening and extending to the front surface of the needle sheath, the width of the second portion being smaller than the width of the engagement portion of the flexible electrode.

[0009] In some embodiments, the flexible electrode includes an electrode body, the junction being located at the front end of the electrode body, wherein the width of the second portion is greater than or equal to the width of the electrode body of the flexible electrode.

[0010] In some embodiments, the first opening further includes a transition portion located between the first portion and the second portion, the transition portion having a width that gradually increases from the front end to the rear end.

[0011] In some embodiments, the inner edge of the first opening is chamfered or rounded.

[0012] In some embodiments, the first side surface of the recess of the guide needle is inclined toward the front end of the needle body relative to the bottom surface of the recess.

[0013] In some embodiments, the second side surface of the recess of the guide needle is inclined toward the rear end of the needle body relative to the bottom surface of the recess.

[0014] In some embodiments, the inner surface of the protrusion of the guide pin is inclined outward at the front end of the protrusion, such that the distance from the inner surface of the protrusion to the bottom surface of the recess gradually increases at the front end of the protrusion.

[0015] In some embodiments, the outer surface of the protrusion of the guide pin is flush with the surface of the guide pin.

[0016] In some embodiments, the tip of the guide needle includes multiple bevels.

[0017] In some embodiments, the angle of each of the plurality of bevels of the guide pin is different from that of each other.

[0018] In some embodiments, a second opening is provided on the bottom surface of the recess of the guide pin.

[0019] In some embodiments, the width of the second opening is smaller than the width of the junction of the flexible electrode and larger than the width of the protrusion of the guide pin.

[0020] In some embodiments, the diameter of the guide pin is in the range of 50 to 500 micrometers.

[0021] In some embodiments, the length of the guide pin is in the range of 10 to 200 mm.

[0022] In some embodiments, the guide pin is made of at least one of tungsten and tungsten alloys.

[0023] In some embodiments, the diameter of the channel of the needle sheath is in the range of 60 to 600 micrometers.

[0024] In some embodiments, the wall thickness of the needle sheath is in the range of 0.05 to 0.5 mm.

[0025] In some embodiments, the needle sheath is made of at least one of stainless steel and titanium alloy.

[0026] In some embodiments, the front end of the needle sheath has a bevel, and the first opening is disposed on the bevel.

[0027] In some embodiments, the rigidity of the guide needle material is greater than the rigidity of the needle sheath material.

[0028] According to a second aspect of this disclosure, an implantation system for a flexible electrode is provided, the implantation system comprising: a fixation module configured to removably fix a flexible electrode having an engagement portion including a through hole; an implantation module including a guiding device according to any embodiment of the first aspect of this disclosure and a driving device for driving the guiding device, the guiding device being configured to engage with the engagement portion of the flexible electrode to guide the flexible electrode for implantation; an imaging module configured to acquire images of the engagement portion of the flexible electrode and the recess of the guide needle of the guiding device; and a movement module configured to move the guiding device.

[0029] In some embodiments, the implantation system further includes: a control module, comprising a host computer and a slave computer, the host computer communicating with the slave computer, wherein: the host computer is configured to receive and display images from the imaging module, receive status data of the implantation module and the motion module sent by the slave computer, and send control commands to the slave computer in automatic mode; and the slave computer is configured to control the implantation module and the motion module in response to receiving control commands from the host computer in automatic mode, or in response to user operation in manual mode.

[0030] According to a third aspect of this disclosure, a guiding method for a flexible electrode is provided, the guiding method using a guiding device to guide the flexible electrode, the guiding device being a guiding device according to any embodiment of the first aspect of this disclosure, the flexible electrode having an engagement portion including a through hole, and the guiding method comprising: driving the guide pin of the guiding device to a first position, at the first position, the recess of the guide pin being located at a first opening of a needle sheath and the protrusion of the guide pin not being exposed to the first opening of the needle sheath; causing relative movement between the guiding device and the flexible electrode such that the engagement portion of the flexible electrode slides into the recess of the guide pin through the first opening of the needle sheath; and driving the guide pin from the first position to a second position along a first direction such that the protrusion of the guide pin is exposed to the first opening of the needle sheath and passes through the through hole of the flexible electrode, thereby enabling the flexible electrode to be carried along with the guide pin, wherein the first direction points from the rear end of the needle sheath to the front end of the needle sheath.

[0031] In some embodiments, at the second position, the recess of the guide needle extends out of the needle sheath.

[0032] In some embodiments, the guiding method further includes: driving the guide needle from a second position to a third position along a first direction, at the third position, where the engagement portion of the flexible electrode carried by the guide needle leaves the first opening of the needle sheath; and driving the guide needle along a second direction opposite to the first direction, such that the flexible electrode disengages from the protrusion of the guide needle.

[0033] The guiding device, implantation system, and guiding method disclosed herein can conveniently achieve the engagement and separation of the guiding needle and the flexible electrode by using the cooperation of the guiding needle and the needle sheath, reducing the probability of damage to the flexible electrode and mechanical disturbance to biological tissues (e.g., brain tissue), improving implantation reliability and reducing the risk of damage. Attached Figure Description

[0034] The foregoing and other features and advantages of this disclosure will become clear from the following description of embodiments illustrated in conjunction with the accompanying drawings. The drawings, incorporated herein and forming a part of the specification, are further used to explain the principles of this disclosure and to enable those skilled in the art to make and use it.

[0035] Figure 1 This is a schematic front view of a guiding device for a flexible electrode according to some embodiments of the present disclosure.

[0036] Figure 2 It is shown schematically. Figure 1 Side view of the guide device shown.

[0037] Figure 3 This is a schematic front view of the needle sleeve of a guide device according to some embodiments of the present disclosure.

[0038] Figure 4 This is a schematic perspective view of a flexible electrode according to some embodiments of the present disclosure.

[0039] Figure 5 This is a schematic perspective view of the needle sleeve of a guide device according to some embodiments of the present disclosure.

[0040] Figure 6 This is a schematic perspective view of the needle sleeve of a guide device according to some embodiments of the present disclosure.

[0041] Figure 7 This is a schematic side view of the recess of the guide pin of a guide device according to some embodiments of the present disclosure.

[0042] Figure 8 The diagram schematically shows a front view and a 45° view of the guide pin of a guide device according to some embodiments of the present disclosure.

[0043] Figure 9 This is a schematic front view of the recess of a guide pin according to some embodiments of the present disclosure.

[0044] Figure 10 This is a flowchart illustrating a method for guiding a flexible electrode according to some embodiments of the present disclosure.

[0045] Figure 11 It shows Figure 10 A schematic diagram of an example of the first position in the guided method shown.

[0046] Figure 12 It shows Figure 10 A schematic diagram of an example of the second position in the guided method shown.

[0047] Figure 13 It shows Figure 10 A schematic diagram of another example of the second position in the guided method shown.

[0048] Figure 14 This shows the application of it. Figure 10 The diagram illustrates an example process of the bootstrapping method.

[0049] Figure 15 This is a schematic block diagram illustrating an implantation system for flexible electrodes according to some embodiments of the present disclosure.

[0050] Figure 16 It is shown schematically. Figure 15 A perspective view of an example of an implantation system shown.

[0051] Figure 17 This is an illustrative representation of some embodiments according to the present disclosure. Figure 16 A perspective view of the fixation module of the implantation system shown.

[0052] Figure 18 This is an illustrative representation of some embodiments according to the present disclosure. Figure 16 The diagram shows a perspective view of the implantation module of the implantation system.

[0053] Figure 19 This is an illustrative representation of some embodiments according to the present disclosure. Figure 16 A perspective view of the imaging module of the implantation system shown.

[0054] Figure 20 This is an illustrative representation of some embodiments according to the present disclosure. Figure 16 A perspective view of the mobile module of the implantation system shown.

[0055] Figure 21 This is a schematic structural diagram illustrating a control module for an implantation system for flexible electrodes according to some embodiments of the present disclosure.

[0056] Note that in the embodiments described below, the same reference numerals are sometimes used across different figures to denote the same parts or parts having the same function, and repeated descriptions are omitted. In this specification, similar reference numerals and letters are used to denote similar items; therefore, once an item is defined in one figure, it does not need to be discussed further in subsequent figures.

[0057] For ease of understanding, the positions, dimensions, and extents of the structures shown in the accompanying drawings and other materials may not represent actual positions, dimensions, and extents. Therefore, the disclosed invention is not limited to the positions, dimensions, and extents disclosed in the accompanying drawings and other materials. Furthermore, the drawings are not necessarily drawn to scale, and some features may be enlarged to show details of specific components.

[0058] The reference numerals in the figure are as follows:

[0059] 10: Guiding device;

[0060] 100: Guide pin, 100-1: Surface of guide pin, 110, 110A, 110B, 110C: Needle tip, 110A-1, 110B-1, 110B-2, 110C-1, 110C-2, 110C-3: Bevel of needle tip, 120: Needle body, 130: Recess, 131: First side surface, 132: Second side surface, 133: Protrusion, 133-1: Inner surface of protrusion, 133-2: Outer surface of protrusion, 134: Bottom surface, 140: Second opening, D: Distance between the inner surface of protrusion and the bottom surface of recess near the rear end, D': Distance between the inner surface of protrusion and the bottom surface of recess near the front end, W6: Width of second opening, W7: Width of protrusion;

[0061] 200: Needle sheath, 210: Channel, 220: First opening, 221: First portion of the first opening, W1: Width of the first portion of the first opening, 222: Second portion of the first opening, W2: Width of the second portion of the first opening, 223: Transition portion of the first opening, W3: Width of the transition portion of the first opening, 224: Inner edge of the first opening, 230: Bevel of the needle sheath, 240: Front surface of the needle sheath;

[0062] 20: Flexible electrode, 21: Joint, W4: Width of joint, 21-1: Through hole, 22: Electrode body, W5: Width of electrode body;

[0063] 40: Implantable system;

[0064] 41: Fixation module; 411: Base of fixation module; 412: Support; 413: Positioning feature; 414: Carrier plate; 50: Implant;

[0065] 42: Implantation module; 421: Cover plate; 422: Base of implantation module; 423: Drive device; 424: Guide pin base; 425: Pressure plate;

[0066] 43: Imaging module; 431: Imaging module base; 432: Camera base; 433: Miniature slide; 434: Camera; 435: Camera lens; 436: Cable groove.

[0067] 44: Moving module; 441: Base of moving module; 442: X-axis motor; 443: Y-axis motor; 444: Z-axis motor; 445: Assembly platform;

[0068] 45: Control module. Detailed Implementation

[0069] Various exemplary embodiments of the present disclosure will now be described in detail with reference to the accompanying drawings. It should be noted that, unless otherwise specifically stated, the relative arrangement, numerical expressions, and values ​​of the components and steps set forth in these embodiments do not limit the scope of the present disclosure.

[0070] The following description of at least one exemplary embodiment is merely illustrative and is in no way intended to limit this disclosure or its application or use. Those skilled in the art will understand that they merely illustrate exemplary ways that can be used to implement this disclosure, and are not exhaustive.

[0071] Techniques, methods, and equipment known to those skilled in the art may not be discussed in detail, but where appropriate, such techniques, methods, and equipment should be considered part of the specification.

[0072] In all examples shown and discussed herein, any specific values ​​should be interpreted as merely exemplary and not as limitations. Therefore, other examples of exemplary embodiments may have different values.

[0073] In this article, "front" can refer to the side that will be closer to the biological tissue and farther from the operator during implantation, and "back" can refer to the side that will be farther from the biological tissue and closer to the operator during implantation.

[0074] The guiding device for flexible electrodes according to various embodiments of the present disclosure will now be described in detail with reference to the accompanying drawings. It will be understood that actual guiding devices may include other components, which are not shown in the drawings and will not be discussed herein in order to avoid obscuring the key points of the disclosure.

[0075] Figure 1 and Figure 2 The guide device 10 is schematically shown according to some embodiments of the present disclosure. Figure 1 A front view of the guide device 10 is shown, and Figure 2 A side view of the guide device 10 is shown. It can be understood that... Figure 1 and Figure 2 From this perspective, "front" refers to the bottom of the image, and "back" refers to the top. The guiding device 10 can be used to guide the implantation of a flexible electrode, which may have a joint including a through-hole. See [example of flexible electrode] for details. Figure 4 The flexible electrode 20 includes a junction 21 and an electrode body 22. The junction 21 is located at the front end of the electrode body 22 and includes a through hole 21-1.

[0076] like Figure 1 and Figure 2 As shown, the guiding device 10 includes a guiding needle 100 and a needle sleeve 200.

[0077] The guide needle 100 includes a needle body 120 and a needle tip 110 located at the front end of the needle body 120. For example, the guide needle 100 may have a circular cross-section with a diameter ranging from 50 to 500 micrometers, but this disclosure is not limited thereto, and the guide needle 100 may have other suitable cross-sectional shapes such as elliptical or polygonal. In some examples, the length of the guide needle 100 may range from 10 to 200 millimeters, depending on actual needs. In some examples, the material of the guide needle 100 includes at least one of tungsten and tungsten alloys. The guide needle 100 may also be made of other high-rigidity materials. For example, the guide needle 100 may be fabricated using suitable processes such as laser processing or machining. The needle tip 110 can be used to puncture biological tissue (e.g., meninges).

[0078] A recess 130 is provided near the front end of the needle body 120. The recess 130 includes a first side surface 131 and a second side surface 132. The first side surface 131 is closer to the front end of the needle body 120 than the second side surface 132. A protrusion 133 is provided on the second side surface 132 extending toward the first side surface 131 (downward in the figure), and the protrusion 133 is configured to pass through the through hole 21-1 of the flexible electrode 20. The recess 130 can provide a receiving space for the engagement portion 21 of the flexible electrode 20 even when the protrusion 133 has passed through the through hole 21-1 of the flexible electrode 20.

[0079] The needle sheath 200 has a hollow structure to provide a channel 210 inside the needle sheath 200. The channel 210 is configured to allow the guide needle 100 to move through it. For example, the guide needle 100 can retract the needle sheath 200 so that the tip 110 of the guide needle 100 can be fully received in the channel 210 of the needle sheath 200, and the guide needle 100 can also extend out of the needle sheath 200, for example, by moving to... Figure 1 The position shown is such that the recess 130 of the guide needle 100 is fully exposed outside the needle sheath 200.

[0080] The shape and size of the channel 210 of the needle sleeve 200 can be designed to fit the shape and size of the guide needle 100. For example, the channel 210 can have a circular cross-section, and the diameter of the channel 210 can be in the range of 60 to 600 micrometers. In some examples, the wall thickness of the needle sleeve 200 can be in the range of 0.05 to 0.5 millimeters. It is understood that those skilled in the art can specifically set the shape and size of the guide needle 100 and the needle sleeve 200 according to actual needs. In some examples, the material of the needle sleeve 200 can include at least one of stainless steel and titanium alloy. The needle sleeve 200 can also be made of other rigid materials. In some embodiments, the rigidity of the material of the guide needle 100 can be greater than the rigidity of the material of the needle sleeve 200. The needle sleeve 200 can be manufactured by suitable processes such as 3D printing or machining.

[0081] A first opening 220 is provided at the front end of the needle sheath 200. The first opening 220 is configured to allow the engagement portion 21 of the flexible electrode 20 to slide into the recess 130 of the guide needle 100 through the first opening 220, so that the protrusion 133 of the guide needle 100 can pass through the through hole 21-1 of the flexible electrode 20 to carry the flexible electrode 20 and move together with the guide needle 100. The first opening 220 can be shaped to provide a support surface for the engagement portion 21 of the flexible electrode 20 to slide thereon, which can both guide the engagement portion 21 of the flexible electrode 20 into the recess 130 of the guide needle 100 and prevent the engagement portion 21 of the flexible electrode 20 from falling out when it is at least partially accommodated in the recess 130 of the guide needle 100.

[0082] Figure 3 Several non-limiting examples of the first opening 220 are depicted. In some embodiments, such as... Figure 3 As shown in part (A), the first opening 220 includes a first portion 221 spaced apart from the front surface 240 (lower surface in the figure) of the needle sheath 200. The width W1 of the first portion 221 may be greater than or equal to the width W4 of the engagement portion 21 of the flexible electrode 20 (e.g., Figure 4(As shown). In some cases, considering that the flexible electrode 20 is flexible and easily flexible, the width W4 of the joint 21 of the flexible electrode 20 can also be slightly larger than the width W1 of the first portion 221 without hindering the joint 21 of the flexible electrode 20 from passing through the first portion 221 of the first opening 220. The leading edge (lower edge in the figure) of the first portion 221 of the first opening 220 can provide a support surface for the joint 21 of the flexible electrode 20. For example, in such an embodiment, when the through hole 21-1 of the joint 21 of the flexible electrode 20 is passed through the protrusion 133 of the guide needle 100 so that the joint 21 of the flexible electrode 20 moves with the guide needle 100 to extend out of the needle sleeve 200, the joint 21 of the flexible electrode 20 can also drive the electrode body 22 of the flexible electrode 20 into the first opening 220 and then out of the needle sleeve 200 along the channel 210.

[0083] In some embodiments, such as Figure 3 As shown in part (B), the first opening 220 includes a first portion 221 spaced apart from the front surface 240 of the needle sheath 200, and also includes a second portion 222 communicating with the first portion 221 of the first opening 220 and extending to the front surface 240 of the needle sheath 200. The width W2 of the second portion 222 may be smaller than the width W4 of the joint 21 of the flexible electrode 20. This width setting ensures that, without external force or when the external force is small, the joint 21 of the flexible electrode 20 will not fall from the first portion 221 of the first opening 220 to the second portion 222, and the front edge (lower edge in the figure) of the first portion 221 of the first opening 220 can still provide a supporting surface for the joint 21 of the flexible electrode 20. For example, in such an embodiment, after the engagement portion 21 of the flexible electrode 20 engages with the protrusion 133 of the guide needle 100, the guide needle 100 moves downward, applying a downward force to the engagement portion 21, causing it to bend and deform, thereby entering the second portion 222 and ultimately disengaging from the needle sheath 200 via the second portion 222. This can be advantageous when the flexible electrode 20 is also connected to other devices (e.g., sensors) at the rear end of its electrode body 22.

[0084] In some embodiments, such as Figure 3As shown in section (C), the first opening 220 includes a first portion 221 spaced apart from the front surface 240 of the needle sheath 200 and a second portion 222 communicating with the first portion 221 and extending to the front surface 240 of the needle sheath 200, and also includes a transition portion 223 located between the first portion 221 and the second portion 222. The transition portion 223 may have a width W3 that gradually increases from the front end to the rear end. The transition portion 223 can provide an inclined support surface for the joint 21 of the flexible electrode 20, which can further guide the joint 21 to bend and deform in the desired direction, so that it folds into the second portion 222 in an inverted arch shape with a low center and high sides, thereby smoothly disengaging from the needle sheath 200, and is less likely to get stuck at the connection between the first portion 221 and the second portion 222, which may lead to excessive external force and damage to the flexible electrode 20. In addition, such a transition portion 223 can also help strengthen the needle sheath 200 at the circumference where the second portion 222 of the first opening 220 is located, especially when the height of the second portion 222 is small.

[0085] In some embodiments, the width W2 of the second portion 222 may be greater than or equal to the width W5 of the electrode body 22 of the flexible electrode 20 (e.g., Figure 4 (As shown). In such an embodiment, after the engagement portion 21 of the flexible electrode 20 engages with the protrusion 133 of the guide needle 100, when the guide needle 100 moves downward so that the engagement portion 21 enters the channel 210 from the first portion 221 of the first opening 220 and exits the needle sheath 200 via the channel 210, the electrode body 22 does not need to follow the engagement portion 21 from the first portion 221 of the first opening 220 into the channel 210, but can exit the needle sheath 200 via the second portion 222. In this way, the flexible electrode 20 can directly detach from the needle sheath 200 without significant deformation, thereby reducing the risk of mechanical damage to the flexible electrode 20. In some cases, considering that the flexible electrode 20 is flexible and easily flexible, the width W5 of the electrode body 22 of the flexible electrode 20 can also be slightly larger than the width W2 of the second portion 222 without hindering the electrode body 22 of the flexible electrode 20 from passing through the second portion 222 of the first opening 220.

[0086] Figure 5 This is a perspective view showing a non-limiting example of the needle sleeve 200. (See image) Figure 5 As shown, the inner edge 224 of the first opening 220 is constructed to be angular. In order to further protect the flexible electrode 20 during the engagement of the guide device 10 with the flexible electrode 20, in some embodiments, the inner edge 224 of the first opening 220 may be chamfered or rounded. Figure 6This is a perspective view showing another non-limiting example of the needle sheath 200. In this example, the inner edge 224 of the first opening 220 is chamfered, i.e., beveled, thereby reducing the likelihood of the flexible electrode 20 being scratched when it contacts the inner edge 224. Figure 12 The illustration depicts a scenario where the inner edge 224 of the first opening 220 is rounded. For example, chamfering or rounding can be achieved through laser processing.

[0087] In some embodiments, the first side surface 131 of the recess 130 of the guide needle 100 is inclined relative to the bottom surface 134 of the recess 130 toward the front end of the needle body 120, such as... Figure 2 As shown. In other words, the angle between the first side surface 131 and the bottom surface 134 of the recess 130 can be an obtuse angle. Such a ramp structure can guide the flexible electrode 20 to move upward or bend more smoothly after entering the recess 130. This reduces the risk of the flexible electrode 20 getting stuck or failing to be fully positioned at the entrance of the recess 130 due to alignment errors in micron-level precision operations, thereby reducing the requirements for the stability of the high-precision robotic arm or operator's hand and improving the operational fault tolerance and reliability of the joining process.

[0088] In some embodiments, the second side surface 132 of the recess 130 of the guide needle 100 is inclined relative to the bottom surface 134 of the recess 130 toward the rear end of the needle body 120, such as... Figure 2 As shown. In other words, the angle between the second side surface 132 and the bottom surface 134 of the recess 130 can be an obtuse angle. This increases the connection area between the protrusion 133 and the second side surface 132, reduces the risk of breakage of the protrusion 133, and improves the reliability of the guide pin 100. In addition, as the flexible electrode 20 moves forward with the guide pin 100, such a second side surface 132 makes it easier for the engagement portion 21 to abut against it, thereby providing stable support and limiting for the engagement portion 21, and preventing it from easily shifting position relative to the guide pin 100.

[0089] Figure 7 This is a partially enlarged side view of the recess 130 of the guide pin 100 according to some embodiments of the present disclosure. In some embodiments, the inner surface 133-1 of the protrusion 133 of the guide pin 100 is inclined outward at the front end of the protrusion 133, such that the distance from the inner surface 133-1 of the protrusion 133 to the bottom surface 134 of the recess 130 gradually increases at the front end of the protrusion 133. Figure 7As shown, the distance D between the inner surface 133-1 of the protrusion 133 and the bottom surface 134 of the recess 130 near the rear end is smaller than the distance D' near the front end. Having such a bevel at the front end of the protrusion 133 increases the space in the recess 130 near the front end of the protrusion 133, facilitating the accommodation of the joint 21 of the flexible electrode 20, and also makes it easier for the protrusion 133 to pass through the through hole 21-1 of the flexible electrode 20. Furthermore, beveling the front end of the protrusion 133 without beveling the main body of the protrusion 133 allows the main body of the protrusion 133 to have a sufficiently large cross-section, resulting in greater rigidity and reducing the risk of breakage.

[0090] In some embodiments, the outer surface 133-2 of the protrusion 133 of the guide needle 100 is flush with the surface 100-1 of the guide needle 100. That is, there is no step at the connection between the protrusion 133 and the needle body 120. This reduces the additional resistance and jamming caused by surface discontinuities when the guide needle 100 carries the flexible electrode 20 through the needle sheath 200 or is implanted into biological tissue, and facilitates the flexible electrode 20 to abut against it for stable support, protecting the flexible electrode 20 and biological tissue from damage. For example, the protrusion 133 of the guide needle 100 can be integrally formed with the body of the guide needle 100. In some examples, the protrusion 133 can also be a separately manufactured component attached to the second side surface 132 of the recess 130 of the guide needle 100. In addition, positioning the protrusion 133 as outward as possible on the second side surface 132 can increase the space inside the protrusion 133 of the recess 130 to accommodate the engagement portion 21 of the flexible electrode 20.

[0091] The needle tip 110 can be implemented in various ways. In some embodiments, the needle tip 110 of the guide needle 100 includes one or more bevels. Figure 8 Several non-limiting examples of the needle tip 110 are shown (distinguished by the suffixes A, B, and C, respectively, rather than being limiting), among which Figure 8 Part (A) shows a bevel 110A-1 of the needle tip 110A. Figure 8 Part (B) shows the two bevels 110B-1 and 110B-2 of the needle tip 110B. Figure 8 Section (C) shows three bevels 110C-1, 110C-2, and 110C-3 of the needle tip 110C. Increasing the number of bevels of the needle tip 110 makes the needle tip 110 sharper, reducing the contact area between the needle tip 110 and biological tissue, thereby helping to reduce resistance during puncture and reduce damage to biological tissue. Different numbers and angles of the bevels of the needle tip 110 can achieve different puncture effects. In some embodiments, the angle of each of the multiple bevels of the needle tip 110 of the guide needle 100 is different from each other. Figure 8Taking part (B) as an example, the inclination of the bevel 110B-1 of the needle tip 110B is greater than that of the bevel 110B-2 of the needle tip 110B. This asymmetrical needle tip design allows the guide needle 100 to actively and slightly turn towards the gentler bevel side during insertion, while concentrating the main tissue cutting and tearing on the steeper bevel side to reduce damage to important tissues on the other side. For example, the bevel of the needle tip 110 can be laser-processed, and the processing angle of the bevel of the needle tip 110 can be in the range of 5 to 85°.

[0092] Figure 9 This is a partially enlarged front view of the recess 130 of the guide pin 100 according to some embodiments of the present disclosure. In some embodiments, a second opening 140 may be provided on the bottom surface 134 of the recess 130 of the guide pin 100. Providing the second opening 140 allows the operator or imaging device to additionally observe the protrusion 133 of the guide pin 100 through the second opening 140, improving the visualization of the engagement and implantation process. For example, refer to... Figure 2 The protrusion 133 can be viewed directly from right to left, or from left to right through the second opening 140. In some embodiments, the width W6 of the second opening 140 can be greater than the width W7 of the protrusion 133 of the guide pin 100. In some embodiments, the second opening 140 can extend further forward than the protrusion 133, such as... Figure 9 As shown. This allows for a more comprehensive observation of the protrusion 133.

[0093] Furthermore, providing a second opening 140 can increase the space for accommodating the joint 21 of the flexible electrode 20 (for example, the second opening 140 can accommodate the arched portion of the joint 21), thereby allowing the guide pin 100 to accommodate joints 21 of more different sizes. In some embodiments, the width W6 of the second opening 140 is smaller than the width W4 of the joint 21 of the flexible electrode 20. This width setting can prevent the joint 21 of the flexible electrode 20 from exiting the guide pin 100 directly from the second opening 140, thus affecting the bonding operation.

[0094] In some embodiments, the front end of the needle sleeve 200 has a bevel, and the first opening 220 is disposed on the bevel. For example... Figure 1 and Figure 2As shown, the bevel 230 of the needle sleeve 200 can be created by beveling the front end of the needle sleeve 200. Since the guide device 10 and the flexible electrode 20 are relatively small, and the imaging devices used to observe them often have a limited depth of field, the area that can achieve sharp focus is very small. Setting the bevel 230 of the needle sleeve 200 makes it easier for the area where the first opening 220 is located to fall within the sharp focus range of the imaging device, thereby allowing the image captured by the imaging device to more clearly show the state of the joint 21 of the flexible electrode 20 in the first opening 220, facilitating observation and subsequent operations.

[0095] In another aspect, this disclosure provides a guiding method for a flexible electrode (e.g., flexible electrode 20) that uses a guiding device 10 according to any embodiment of this disclosure to guide the flexible electrode. Figure 10 This is a flowchart illustrating a guiding method 30 for a flexible electrode according to some embodiments of the present disclosure. Figure 10 As shown, the guiding method 30 includes steps S302 to S306.

[0096] In step S302, the guide needle 100 of the guide device 10 is driven to a first position. At the first position, the recess 130 of the guide needle 100 is located at the first opening 220 of the needle sleeve 200 and the protrusion 133 of the guide needle 100 is not exposed to the first opening 220 of the needle sleeve 200.

[0097] Figure 11 A non-limiting example of the first position is shown. For example... Figure 11 As shown, in the first position, the protrusion 133 substantially does not extend beyond the rear edge of the first opening 220, thereby allowing the flexible electrode 20 to be inserted into the recess 130. In some cases, the front end of the protrusion 133 may protrude slightly, as long as it does not affect the insertion of the flexible electrode 20 into the recess 130.

[0098] In step S304, a relative movement is caused between the guide device 10 and the flexible electrode 20, so that the joint portion 21 of the flexible electrode 20 slides into the recess 130 of the guide needle 100 through the first opening 220 of the needle sleeve 200.

[0099] In step S306, the guide needle 100 is driven from a first position to a second position along a first direction, such that the protrusion 133 of the guide needle 100 is exposed to the first opening 220 of the needle sleeve 200 and passes through the through hole 21-1 of the flexible electrode 20, thereby enabling the flexible electrode 20 to move together with the guide needle 100. The first direction points from the rear end of the needle sleeve 200 to the front end of the needle sleeve 200, i.e., the forward direction.

[0100] In some embodiments, at the second position, the recess 130 of the guide pin 100 extends out of the needle sleeve 200 to engage with the first opening 220 to lock the engagement portion 21 of the flexible electrode 20, thereby securely attaching the flexible electrode 20 to the guide pin 100 so that it moves with the guide pin. Non-limiting examples of the second position include... Figure 12 and Figure 13 As shown, the rear end of the protrusion 133 may extend at least beyond the front edge of the first portion 221 of the first opening 220 (e.g., Figure 12 As shown), even extending beyond the front surface 240 of the needle sheath 200 (as shown). Figure 13 (As shown).

[0101] In some embodiments, the guiding method 30 further includes: driving the guide needle 100 from a second position to a third position along a first direction, at the third position, where the engagement portion 21 of the flexible electrode 20 carried by the guide needle 100 exits the first opening 220 of the needle sheath 200. For example, referring to the various embodiments described above with respect to the first opening 220, when the guide needle 100 moves to the third position, the engagement portion 21 of the flexible electrode 20 can be pulled into the channel 210 and then exit the needle sheath 200 via the channel 210, or the engagement portion 21 of the flexible electrode 20 can be pulled from the first portion 221 of the first opening 220 into the second portion 222 and then exit the needle sheath 200 via the second portion 222.

[0102] In some embodiments, the guiding method 30 further includes driving the guide pin 100 in a second direction opposite to the first direction (e.g., a rearward direction) such that the flexible electrode 20 disengages from the protrusion 133 of the guide pin 100. In this case, the inclined first side surface 131 of the recess 130 facilitates the smooth slippage of the flexible electrode 20.

[0103] Figure 14 A schematic diagram illustrating the process of applying the guiding method 30 is shown. For example... Figure 14 As shown in part (A), the engagement portion 21 of the flexible electrode 20 has slid into the recess 130 of the guide needle 100 through the first opening 220 of the needle sleeve 200, and the protrusion 133 of the guide needle 100 has passed through the through hole 21-1 of the engagement portion 21 of the flexible electrode 20. The recess 130 and protrusion 133 of the guide needle 100, together with the first opening 220 of the needle sleeve 200, together limit the engagement portion 21 of the flexible electrode 20.

[0104] like Figure 14As shown in section (B), the guide needle 100 has been driven to the third position. The flexible electrode 20 is not limited by the combined action of the recess 130 and protrusion 133 of the guide needle 100 and the first opening 220 of the needle sleeve 200, but rather abuts against the protrusion 133 due to the downward (first direction) movement of the guide needle 100. Note that for ease of illustration, the flexible electrode 20 is depicted as horizontal, but in reality it can rest against the outer surface of the needle sleeve 200. To separate the flexible electrode 20 from the guide needle 100, simply drive the guide needle 100 backward, and the flexible electrode 20 will automatically detach from the protrusion 133.

[0105] Therefore, the guiding device disclosed herein, through the mechanical structure of the guide needle and the needle sleeve cooperating, can conveniently and smoothly realize the engagement and separation of the flexible electrode and the guiding device without the assistance of other separate mechanisms. It is simple to operate, reliable, has a low probability of damaging the flexible electrode, and generates little mechanical disturbance.

[0106] In another aspect, this disclosure proposes an implantation system for flexible electrodes. Figure 15 An implantation system 40 for a flexible electrode according to some embodiments of the present disclosure is shown. For example... Figure 15 As shown, the implantation system 40 includes a fixation module 41, an implantation module 42, an imaging module 43, and a movement module 44. The fixation module 41 is configured to removably fix a flexible electrode (e.g., one or more flexible electrodes 20), the flexible electrode having a joint including a through-hole. The implantation module 42 includes a guide device 10 and a drive device 423 for driving the guide device 10. The guide device 10 is configured to engage with the joint 21 of the flexible electrode 20 to guide the flexible electrode 20 for implantation. The imaging module 43 is configured to acquire images of the joint 21 of the flexible electrode 20 and the recess 130 of the guide needle 100 of the guide device 10. The movement module 44 is configured to move the guide device 10.

[0107] For the purpose of non-restrictive description, Figure 16 An example of the implantation system 40 is shown. (e.g.) Figure 16 As shown, the implantation system 40 includes a fixation module 41, an implantation module 42, an imaging module 43, and a movement module 44. For example, Figure 16 The implantation system 40 shown can be mounted as a whole on the robotic arm to achieve a greater range of displacement.

[0108] Figure 17 It shows Figure 16An example implementation of the fixation module 41 of the implantation system 40 is shown. The fixation module 41 may include a base 411, a support 412 disposed on the base 411, and a positioning feature 413 disposed on the support 412. The base 411 and the support 412 of the fixation module 41 may be fixedly connected by screws or integrally formed by 3D printing. The positioning feature 413 is configured to fix the implant 50 and the carrier plate 414 (e.g., a silicon plate) for arranging the flexible electrodes 20. The positioning feature 413 may fix the carrier plate 414 and the implant 50 by means of adhesive or vacuum adsorption. One or more flexible electrodes 20 may be pre-assembled on the carrier plate 414 to form a complete implantation unit with the implant 50 (which may be mechanically and electrically connected to the flexible electrodes 20, such as a sensor), and at least a portion (e.g., the tip) of the flexible electrodes 20 on the carrier plate 414 may be in a released state. Figure 17 Part (A) shows the entirety of the fixing module 41, part (B) shows an enlarged view of the positioning feature 413, and part (C) shows an enlarged view of the multiple flexible electrodes 20 arranged on the carrier plate 414.

[0109] Figure 18 It shows Figure 16 The illustration shows an example implementation of the implantation module 42 of the implantation system 40. The implantation module 42 may include a cover plate 421, a base 422 of the implantation module 42, a drive device 423 (e.g., which may be implemented as a stepper motor, and thus also referred to as an implantation motor), a guide needle base 424, a pressure plate 425, a needle sheath 200, and a guide needle 100. The base 422 and the cover plate 421 of the implantation module 42 form a housing for accommodating the drive device 423 and the guide device (“guide needle 100 + needle sheath 200”). The drive device 423 and the guide needle base 424 may be mounted on the base 422 of the implantation module 42. The needle sheath 200 may be fixed to the base 422 of the implantation module 42 by the pressure plate 425. The guide needle 100 may be mounted via the guide needle base 424 and, guided and protected by the needle sheath 200, driven by the drive device 423 to perform precise implantation actions (e.g., forward) and withdrawal actions (e.g., backward). For example, the drive device 423 has an accuracy of 1–10 micrometers and a stroke of 5–50 millimeters. The cover plate 421, the base 422 of the implantation module 42, the guide pin base 424, and the pressure plate 425 can be made of materials such as titanium, stainless steel, or polyetheretherketone, and can be manufactured by 3D printing or machining. Figure 18 Part (A) shows the entire implantation module 42, part (B) shows the implantation module 42 after the cover plate 421 is removed, and part (C) shows an enlarged view of the guide device with guide needle 100 and needle sheath 200.

[0110] Figure 19 It shows Figure 16The illustrated implantation system 40 includes an example implementation of the imaging module 43. The imaging module 43 may include a base 431, a camera base 432, a miniature slide 433, a camera 434, a camera lens 435, and a cable groove 436. The base 431 of the imaging module 43 may have adjustable screw holes arranged in an M×N matrix (M and N can both range from 2 to 10). The camera base 432 can be selectively connected to adjacent or spaced screw holes to achieve fixation and pose adjustment with the base 431 of the imaging module 43. The miniature slide 433 can be mounted on the camera base 432 with screws. The camera 434 is fixed to the miniature slide 433 and equipped with a camera lens 435 (e.g., a telephoto lens) for real-time visual monitoring and positioning. The two cameras 434 can be arranged in a mirror-symmetrical manner, and the tilt angle of the camera base 432 of each camera 434 can be between 45 degrees and 120 degrees. The base 431 of the imaging module 43 and the camera base 432 can be made of metals such as titanium and stainless steel, and can be manufactured by 3D printing or machining. The camera lens 435 can integrate visible light, ultraviolet light, and / or infrared light sources, and its focal length range can be 20–100 nanometers. All cables can be neatly led out through preset cable channels 436 to keep the working area clean and avoid signal interference. The implanted module 42 can be connected to the imaging module 43, and the imaging module 43 can be connected to the moving module 44.

[0111] Figure 20 It shows Figure 16 The illustrated example implementation of the moving module 44 of the implantation system 40 is shown. The moving module 44 may include a base 441, an X-axis motor 442, a Y-axis motor 443, a Z-axis motor 444, and an assembly platform 445. The base 441 of the moving module 44 can be fixed to the main frame with screws, and the base 411 of the fixing module 41 can be connected to the base 441 of the moving module 44 with screws. The base 441 of the moving module 44 may be made of titanium alloy, stainless steel, or other high-strength materials and is fabricated through machining or 3D printing. The assembly platform 445 can be fixedly connected to the base 431 of the imaging module 43 with screws. For example, the X-axis motor 442, Y-axis motor 443, and Z-axis motor 444 may be high-precision stepper motors with a motion accuracy range of 1–10 micrometers, a stroke range of 5–50 millimeters, and a maximum load capacity of 10 kg.

[0112] In some embodiments, the implantation system for flexible electrodes may further include a control module. The control module may include a host computer and a slave computer. The host computer communicates with the slave computer. The host computer may be configured to receive and display images from the imaging module, receive status data of the implantation module and the movement module sent by the slave computer, and send control commands to the slave computer in automatic mode. The slave computer may be configured to control the implantation module and the movement module in response to receiving control commands from the host computer in automatic mode, or in response to user operation in manual mode.

[0113] Figure 21 It shows Figure 16 The illustration shows an example implementation of the control module 45 of the implantation system 40. The host computer can be dedicated software running on a personal computer (PC), responsible for receiving and displaying images from the two cameras 434 (camera 1 and camera 2) in real time, allowing the operator or control program to determine the relative position of the flexible electrode 20 and the guiding device (specifically, the guiding needle 100). Simultaneously, the host computer can communicate with the slave computer via serial port 1, receiving motor status data (including the implanted motor in the drive device 423 of the implantation module 42, and the X-axis motor 442, Y-axis motor 443, and Z-axis motor 444 of the movement module 44), and can send target position, speed settings, and emergency stop commands to the slave computer. The slave computer program can be implemented based on the STM32F407VET6 development board, with both automatic and manual operating modes. In automatic mode, the host computer generates control commands (target position, speed setting, emergency stop command, etc.) based on the image and status data. The slave computer receives the commands from the host computer and drives the motor to automatically run to the set position at the set speed, or to stop urgently. In manual mode, the operator can perform manual operations based on the images displayed on the host computer: for example, by using a four-dimensional joystick with an insertion button (which communicates with the lower-level computer via serial port 2) to control the forward movement of the X-axis motor 442, Y-axis motor 443, and Z-axis motor 444 of the moving module 44, as well as the implantation motor in the drive device 423 of the implantation module 42, and by using buttons (e.g., insertion button, withdrawal button, and emergency stop button) to control the implantation, withdrawal, and stopping of the guide needle 100. Furthermore, the motor power switch can also be used as a hardware emergency stop button.

[0114] For illustrative purposes, a non-limiting example process for implementing the guidance method 30 using the implantation system 40 is described below.

[0115] First, the implantation module 42 is moved close to the fixing module 41 by the moving module 44 (e.g., X-axis motor 442, Y-axis motor 443, and Z-axis motor 444) so ​​that the tip of the flexible electrode 20 to be implanted is aligned with the first opening 220 of the needle sleeve 200, and the guide needle 100 is driven to the first position (e.g., as shown in the image) by the driving device 423 in the implantation module 42. Figure 11 As shown), the recess 130 of the guide needle 100 is located at the first opening 220 of the needle sheath 200 and the protrusion 133 of the guide needle 100 is not exposed to the first opening 220 of the needle sheath 200.

[0116] Then, the camera 434 of the imaging module 43 acquires images of the guide needle 100 and the flexible electrode 20 (specifically, images of the recess 130 of the guide needle 100 and the joint 21 of the flexible electrode 20) to determine their relative positions. The control module 45 controls the movement module 44 to move, so that the flexible electrode 20 slides accurately into the recess 130 of the guide needle 100 through the first opening 220 of the needle sheath 200. Further, the driving device 423 in the implantation module 42 drives the guide needle 100 forward so that the protrusion 133 of the guide needle 100 is exposed to the first opening 220 of the needle sheath 200 and passes through the through hole 21-1 of the flexible electrode 20. After that, it continues to be driven to a second position (e.g., as shown in the image). Figure 12 or Figure 13 As shown), it engages with the first opening 220 of the needle sleeve 200 to hold the joint 21 of the flexible electrode 20.

[0117] Next, the implantation module 42 (with the flexible electrode 20 attached to its guide needle 100) is moved by the moving module 44 to a position directly above the target location (e.g., 5–20 mm). The target location can be an external location set for testing or debugging the implantation system 40, or a target implantation point within biological tissue. After pressing the needle insertion button, the guide needle 100 carries the flexible electrode 20 to the target location. During this process, the flexible electrode 20 is smoothly detached from the carrier plate 414. Finally, the guide needle 100 is withdrawn from the target location by pressing the needle withdrawal button, and the flexible electrode 20 automatically detaches from the protrusion 133 (if the target location is within the target biological tissue, the flexible electrode 20 will remain within the biological tissue). Thus, a single implantation is completed; repeating this process allows for the implantation of multiple flexible electrodes 20.

[0118] This disclosure utilizes a combination of a guide needle and a needle sheath, eliminating the need for complex transmission mechanisms. All necessary actions for flexible electrode implantation can be completed with simple axial movement, reducing the risk of mechanical failure and improving overall operational stability. During implantation, the multi-beveled structure of the guide needle tip allows for smoother puncture of the meninges, effectively reducing puncture resistance and physical damage to brain tissue. Simultaneously, the inner edge of the needle sheath is chamfered or rounded to prevent the flexible electrode from rubbing against or snagging on sharp edges, protecting the physical morphology and functional integrity of the flexible electrode. Thus, the entire approach significantly reduces the possibility of damage to the flexible electrode while ensuring implantation accuracy and minimizing mechanical disturbance to brain tissue during the procedure.

[0119] The terms “left,” “right,” “front,” “back,” “top,” “bottom,” “upper,” “lower,” “high,” “lower,” etc., used in the specification and claims, if present, are for descriptive purposes and not necessarily for describing unchanging relative positions. It should be understood that such terms are interchangeable where appropriate, enabling embodiments of this disclosure described herein to operate, for example, in orientations different from those shown or otherwise described herein. For example, when the device in the drawings is reversed, a feature previously described as “above” other features may now be described as “below” other features. The device may also be oriented in other ways (rotated 90 degrees or in other orientations), in which case the relative spatial relationships will be interpreted accordingly.

[0120] In the specification and claims, when an element is described as being "on top of," "attached to," "connected to," "coupled to," or "in contact with" another element, the element may be directly located on top of, directly attached to, directly connected to, directly coupled to, or directly in contact with the other element, or one or more intermediate elements may be present. Conversely, when an element is described as being "directly" located on top of, directly attached to, directly connected to, directly coupled to, or directly in contact with another element, no intermediate elements are present. In the specification and claims, when a feature is arranged "adjacent" to another feature, it may mean that a feature has a portion overlapping with the adjacent feature or a portion located above or below the adjacent feature.

[0121] As used herein, the term “exemplary” means “serving as an example, instance, or illustration” and not as a “model” to be precisely copied. Any implementation described herein by example is not necessarily to be construed as preferred or advantageous over other implementations. Moreover, this disclosure is not limited to any theory expressed or implied as given in the field of art, background art, summary of invention, or detailed description.

[0122] As used herein, the term "substantially" means any minor variation resulting from design or manufacturing defects, device or component tolerances, environmental influences, and / or other factors. The term "substantially" also allows for differences from the perfect or ideal situation due to parasitic effects, noise, and other practical considerations that may exist in the actual implementation.

[0123] Additionally, terms such as “first,” “second,” etc., may be used herein for reference only and are therefore not intended to be limiting. For example, unless the context clearly indicates otherwise, the words “first,” “second,” and other such numerical terms relating to structures or elements do not imply order or sequence. It should also be understood that the term “including / contains,” when used herein, indicates the presence of the indicated feature, whole, step, operation, unit, and / or component, but does not preclude the presence or addition of one or more other features, wholes, steps, operations, units, and / or components, and / or combinations thereof.

[0124] In this disclosure, the term “provide” is used broadly to cover all ways of obtaining an object, and therefore “provide an object” includes, but is not limited to, “purchasing,” “preparing / manufacturing,” “arranging / setting up,” “installing / assembling,” and / or “ordering” an object.

[0125] As used herein, the term “and / or” includes any and all combinations of one or more of the listed items in association. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of this disclosure. As used herein, the singular forms “a,” “an,” and “the” are also intended to include the plural forms unless the context clearly indicates otherwise.

[0126] Those skilled in the art will recognize that the boundaries between the above operations are merely illustrative. Multiple operations may be combined into a single operation, a single operation may be distributed among additional operations, and operations may be performed with at least partial overlap in time. Moreover, alternative embodiments may include multiple instances of a particular operation, and the order of operations may be changed in various other embodiments. However, other modifications, variations, and substitutions are equally possible. Aspects and elements of all the embodiments disclosed above may be combined in any way and / or in combination with aspects or elements of other embodiments to provide multiple additional embodiments. Therefore, this specification and the accompanying drawings should be considered illustrative rather than restrictive.

[0127] While specific embodiments of this disclosure have been described in detail by way of example, those skilled in the art should understand that the examples are for illustrative purposes only and not intended to limit the scope of this disclosure. The various embodiments disclosed herein can be combined in any way without departing from the spirit and scope of this disclosure. Those skilled in the art should also understand that various modifications can be made to the embodiments without departing from the scope and spirit of this disclosure. The scope of this disclosure is defined by the appended claims.

Claims

1. A guiding device for a flexible electrode, characterized in that, The flexible electrode has a joint including a through hole, and the guiding device includes: A guide needle, comprising a needle body and a needle tip located at the front end of the needle body, a recessed portion provided near the front end of the needle body, the recessed portion comprising opposing first and second side surfaces, the first side surface being closer to the front end of the needle body than the second side surface, and a protrusion extending toward the first side surface provided on the second side surface, the protrusion being configured to pass through the through-hole of the flexible electrode; and A needle sheath having a hollow structure to provide a channel inside the needle sheath, the channel being configured to allow the guide needle to move through it, and a first opening provided at the front end of the needle sheath, the first opening being configured to allow the engagement portion of the flexible electrode to slide into the recess of the guide needle via the first opening, such that the protrusion of the guide needle can pass through the through-hole of the flexible electrode to carry the flexible electrode along with the guide needle.

2. The guiding device according to claim 1, characterized in that, The first opening includes a first portion spaced apart from the front surface of the needle sheath, the width of the first portion being greater than or equal to the width of the engagement portion of the flexible electrode.

3. The guiding device according to claim 2, characterized in that, The first opening further includes a second portion communicating with the first portion of the first opening and extending to the front surface of the needle sheath, the width of the second portion being smaller than the width of the engagement portion of the flexible electrode.

4. The guiding device according to claim 3, characterized in that: The flexible electrode includes an electrode body, and the junction is located at the front end of the electrode body, wherein the width of the second portion is greater than or equal to the width of the electrode body of the flexible electrode; and / or The first opening also includes a transition portion located between the first portion and the second portion, the transition portion having a width that gradually increases from the front end to the rear end.

5. The guiding device according to claim 1, characterized in that: The inner edge of the first opening is chamfered or rounded; and / or The front end of the needle sheath has a bevel, and the first opening is disposed on the bevel.

6. The guiding device according to claim 1, characterized in that: The first side surface of the recess of the guide needle is inclined toward the front end of the needle body relative to the bottom surface of the recess; and / or The second side surface of the recess of the guide needle is inclined toward the rear end of the needle body relative to the bottom surface of the recess.

7. The guiding device according to claim 1, characterized in that, The inner surface of the protrusion of the guide pin is inclined outward at the front end of the protrusion, such that the distance from the inner surface of the protrusion to the bottom surface of the recess gradually increases at the front end of the protrusion.

8. The guiding device according to claim 1, characterized in that, The tip of the guide needle includes multiple bevels, wherein the angle of each bevel is different from that of the others.

9. The guiding device according to claim 1, characterized in that, A second opening is provided on the bottom surface of the recess of the guide pin, wherein the width of the second opening is smaller than the width of the joint of the flexible electrode and larger than the width of the protrusion of the guide pin.

10. The guiding device according to claim 1, characterized in that: The diameter of the guide pin is in the range of 50 to 500 micrometers; and / or The length of the guide pin is in the range of 10 to 200 mm; and / or The guide pin is made of at least one of tungsten and tungsten alloys; and / or The diameter of the channel in the needle sheath is in the range of 60 to 600 micrometers; and / or The wall thickness of the needle sheath is in the range of 0.05~0.5 mm; and / or The needle sheath is made of at least one of stainless steel and titanium alloy.

11. An implantation system for flexible electrodes, characterized in that, The implantation system includes: A fixing module is configured to removably fix a flexible electrode, the flexible electrode having a joint including a through hole; An implantation module includes a guiding device according to any one of claims 1 to 10 and a driving device for driving the guiding device, the guiding device being configured to engage with the junction of the flexible electrode to guide the flexible electrode for implantation; An imaging module is configured to acquire images of the junction of the flexible electrode and the recess of the guide pin of the guiding device; and A moving module is configured to move the guiding device.

12. The implantation system according to claim 11, characterized in that, The implantation system also includes: The control module includes a host computer and a slave computer, wherein the host computer communicates with the slave computer, wherein: The host computer is configured to receive and display images from the imaging module, receive status data of the implantation module and the motion module sent by the slave computer, and send control commands to the slave computer in automatic mode; and The lower-level machine is configured to control the implanted module and the mobile module in response to receiving a control command from the upper-level machine in automatic mode, or in response to a user operation in manual mode.

13. A method for guiding a flexible electrode, characterized in that, The guiding method uses a guiding device to guide the flexible electrode, the guiding device being the guiding device according to any one of claims 1 to 10, the flexible electrode having a joint including a through hole, and the guiding method comprising: The guide needle of the guiding device is driven to a first position, in which the recess of the guide needle is located at the first opening of the needle sheath and the protrusion of the guide needle is not exposed to the first opening of the needle sheath. This causes relative movement between the guiding device and the flexible electrode, such that the engagement portion of the flexible electrode slides into the recess of the guiding needle through the first opening of the needle sheath; and The guide needle is driven from the first position to the second position along a first direction, such that the protrusion of the guide needle is exposed to the first opening of the needle sleeve and passes through the through hole of the flexible electrode, thereby enabling the flexible electrode to move together with the guide needle. The first direction points from the rear end of the needle sheath to the front end of the needle sheath.

14. The guiding method according to claim 13, characterized in that, At the second position, the recess of the guide needle extends out of the needle sheath.

15. The guiding method according to claim 13, characterized in that, The guiding method also includes: The guide needle is driven from the second position to the third position along the first direction, at which the engagement portion of the flexible electrode carried by the guide needle exits the first opening of the needle sheath; and The guide pin is driven in a second direction opposite to the first direction, causing the flexible electrode to disengage from the protrusion of the guide pin.

Images