Flexible electrode implant assembly, temporary neurostimulator system, and implantable neurostimulator system

Abstract

The application provides a flexible electrode implanting assembly, a temporary nerve stimulator system and an implantable nerve stimulator system. The flexible electrode implanting assembly comprises a flexible paddle electrode, a flexible traction tube and a first guide wire. The flexible paddle electrode comprises a distal contact portion, and the distal contact portion is provided with an auxiliary fixing portion. The flexible traction tube is provided with a distal outlet and a distal inlet. The first guide wire is movably arranged in the flexible traction tube, the distal end of the first guide wire is connected with the auxiliary fixing portion after being led out of the distal outlet, and the first guide wire is led back into the lumen through the distal inlet, so that a detachable traction ring portion is formed outside the flexible traction tube to constrain the auxiliary fixing portion to the outer wall of the flexible traction tube. The above structure can realize reliable delivery through the flexible traction tube and the first guide wire when the flexible paddle electrode is delivered, and the distal end of the flexible paddle electrode is attached to the outer wall of the flexible traction tube, which can effectively solve the problem that the flexible paddle electrode cannot be minimally invasively and accurately implanted into the target position due to its own size.

Description

Technical Field

[0001] This application relates to the field of flexible electrode implantation technology, and in particular to a flexible electrode implantation component, a temporary neurostimulator system, and an implantable neurostimulator system. Background Technology

[0002] Spinal cord stimulation (SCS) modulates the nervous system by implanting electrodes in the epidural space of the spinal cord and outputting electrical pulses through a pulse generator. It has been used to treat conditions such as chronic intractable pain. Currently, paddle electrodes (or surgical electrodes) are used clinically to provide greater stimulation coverage and a lower risk of displacement. However, paddle electrodes are typically 3–14 mm wide and about 2 mm thick, often with 8 or 16 contacts. When precise placement of the paddle electrode in the target tissue is required, its large width and thickness necessitate more complex techniques for implantation, such as precise navigation, image guidance, or other methods to aid in localization, increasing the difficulty and complexity of accurate surgical placement. Furthermore, paddle electrode implantation often requires open surgery such as laminectomy / spinal incision, which is more invasive to the patient, affecting treatment effectiveness and patient safety. Summary of the Invention

[0003] In view of the above-mentioned technical problems existing in the prior art, this application provides a flexible electrode implantation component, a temporary neurostimulator system, and an implantable neurostimulator system.

[0004] This application provides a flexible electrode implantation assembly, including:

[0005] A flexible paddle electrode includes a proximal contact portion, a lead wire connection portion, and a distal contact portion connected sequentially along the length direction of the flexible paddle electrode. The distal contact portion includes at least one electrode contact for applying electrical stimulation to tissue at a target location and / or acquiring potential signals, and the distal contact portion is provided with an auxiliary fixing portion.

[0006] A flexible traction tube has a pair of distal outlets and distal inlets on its tube wall. The flexible paddle electrode is located outside the flexible traction tube, and the auxiliary fixing part covers the tube wall area between the distal outlet and the distal inlet.

[0007] The first guide wire is movably inserted into the lumen of the flexible traction tube. The distal end of the first guide wire passes through the distal outlet and is connected to the auxiliary fixing part. It then passes back into the lumen through the distal inlet, thereby forming a detachable traction ring on the outside of the flexible traction tube to constrain the auxiliary fixing part to the outer wall of the flexible traction tube, so as to pull the distal contact part of the flexible paddle electrode to the target position via the flexible traction tube.

[0008] In some embodiments, there are multiple auxiliary fixing parts, and the multiple auxiliary fixing parts are spaced apart at least along the length direction of the flexible paddle electrode.

[0009] In some embodiments, the flexible traction tube has multiple pairs of distal outlets and distal inlets sequentially arranged on its wall, and the multiple pairs of distal outlets and distal inlets are arranged one-to-one with multiple auxiliary fixing parts.

[0010] In some embodiments, the first guidewire passes sequentially through each pair of distal outlets, corresponding auxiliary fixation portions, and corresponding distal inlets to form a plurality of detachable traction ring portions along the length direction of the flexible traction tube, thereby fitting and constraining the distal contact portion of the flexible paddle electrode to the outer wall of the flexible traction tube to prevent the flexible paddle electrode from deflecting or twisting relative to the axis of the flexible traction tube during implantation.

[0011] In some embodiments, the first guidewire is one or more.

[0012] In some embodiments, the auxiliary fixing part is a through connection hole, and the distal end of the first guide wire passes through the through connection hole to connect with the auxiliary fixing part, so that a detachable traction ring is formed between the first guide wire and the auxiliary fixing part.

[0013] In some embodiments, the through connection hole of the auxiliary fixing part is disposed at the farthest end of the flexible paddle electrode, and the far end of the first guidewire passes through the far end outlet, the through connection hole and the far end inlet in sequence back into the lumen, so that a detachable traction ring is formed between the first guidewire and the auxiliary fixing part.

[0014] In some embodiments, the through connection hole of the auxiliary fixing part includes a pair of through-hole bodies and through-hole bodies, and the distal end of the first guide wire passes through the distal outlet, the through-hole body, the through-hole body and the distal inlet in sequence back into the lumen, so that a detachable traction ring is formed between the first guide wire and the auxiliary fixing part.

[0015] In some embodiments, there are multiple pairs of through-holes and through-holes, and the first guidewire passes through each pair of through-holes and through-holes in sequence.

[0016] In some embodiments, the flexible electrode implantation assembly further includes a second guidewire disposed within the lumen of the flexible traction tube, and the second guidewire is used to provide axial support force to the flexible traction tube.

[0017] In some embodiments, the bending stiffness of the second guidewire is greater than that of the first guidewire.

[0018] In some embodiments, the proximal end of the first guidewire is connected to the proximal end of the second guidewire so as to drive the first guidewire to move synchronously along the length direction of the second guidewire via the second guidewire.

[0019] In some embodiments, the flexible electrode implantation assembly further includes a positioning guide sheath having an inner cavity extending through both ends thereof, the inner cavity of the positioning guide sheath being used to accommodate the flexible paddle electrode and the flexible traction tube to provide a percutaneous puncture pathway for the flexible paddle electrode and the flexible traction tube.

[0020] In some embodiments, the distal end face of the positioning guide sheath is spiked.

[0021] In some embodiments, the distal end of the positioning guide sheath has a curved structure with the opening of the curved structure facing the target position, so as to guide the movement direction of the flexible paddle electrode and the flexible traction tube after they pass through the positioning guide sheath via the curved structure.

[0022] In some embodiments, the width of the distal contact portion of the flexible paddle electrode is greater than the inner diameter of the positioning guide sheath; and / or, the width of the distal contact portion of the flexible paddle electrode is less than the inner circumference of the positioning guide sheath.

[0023] In some embodiments, the flexible paddle electrode has a curled state and a flat state. The flexible paddle electrode is in the curled state, which is curled along its width direction, within the inner cavity of the positioning guide sheath. After passing through the positioning guide sheath, the flexible paddle electrode unfolds to the flat state.

[0024] In some embodiments, the distal contact portion of the flexible paddle electrode is provided with at least one deformation guide portion, which is used to provide a deformable region for bending of the flexible paddle electrode along its width direction and / or length direction.

[0025] In some embodiments, the deformation guide is configured as an elongated structure, and the length direction of the deformation guide is the same as the length direction of the flexible paddle electrode.

[0026] In some embodiments, the deformation guide is a slit structure that extends through the thickness direction of the flexible paddle electrode.

[0027] In some embodiments, the deformation guide is a groove disposed on the surface of the flexible paddle electrode, and the groove is located on the outer side of the flexible paddle electrode when it is bent along its length direction.

[0028] In some embodiments, the flexible paddle electrode includes a first insulating layer, a conductive layer, and a second insulating layer stacked sequentially, the groove being formed on the first insulating layer and / or the second insulating layer, and the groove depth being less than the sum of the thicknesses of the first insulating layer and the second insulating layer.

[0029] In some embodiments, there are multiple deformation guides, and the multiple deformation guides are spaced apart along the length direction of the flexible paddle electrode; or, there are multiple deformation guides, and the multiple deformation guides are spaced apart along the length direction and width direction of the flexible paddle electrode.

[0030] In some embodiments, the proximal opening of the positioning guide sheath forms an flared structure with a gradually increasing inner diameter from far to near.

[0031] In some embodiments, the flexible traction tube is provided with a first imaging mark at a position where the distance between its distal end and the positioning guide sheath is a preset length; and / or, the distal contact portion of the flexible paddle electrode is provided with a plurality of second imaging marks.

[0032] In some embodiments, the lead connection portion of the flexible paddle electrode is provided with a stitching structure on one or both edges in the width direction. The stitching structure is used to pass through a suture to fix the flexible paddle electrode at the target position.

[0033] In some embodiments, the width of the distal contact portion of the flexible paddle electrode is greater than the outer diameter of the flexible traction tube.

[0034] In some embodiments, the distal end of the flexible traction tube is configured as a closed, smooth structure.

[0035] This application also provides a temporary neurostimulator system, including the flexible electrode implantation assembly described in any of the above embodiments, and an external stimulator, the external stimulator including an electrical stimulation circuit and / or a data acquisition circuit, the external stimulator being detachably connected to the flexible paddle electrode.

[0036] This application also provides an implantable neurostimulator system, including the flexible electrode implantation assembly described in any of the above embodiments, and an implantable stimulator, wherein the implantable stimulator includes an electrical stimulation circuit and / or a data acquisition circuit, and the implantable stimulator is detachably connected to the flexible paddle electrode.

[0037] Compared with the prior art, the beneficial effects of the embodiments of this application are as follows: The distal end of the first guidewire of this application can pass through the distal outlet on the flexible traction tube and connect with the auxiliary fixing part, and pass back into the tube cavity through the distal inlet, thereby forming a detachable traction ring part outside the flexible traction tube to constrain the auxiliary fixing part to the outer wall of the flexible traction tube. This enables reliable delivery of the flexible paddle electrode through the flexible traction tube and the first guidewire. The distal end of the flexible paddle electrode is attached to the outer wall of the flexible traction tube, which can effectively solve the problem of inaccurate implantation to the target position due to the size of the flexible paddle electrode itself. Furthermore, the first guidewire can achieve controllable release and rapid decoupling of the flexible paddle electrode, possessing detachability and robustness. It ensures reliable axial linkage during the delivery stage and can quickly release the fixation of the flexible paddle electrode after implantation to the target position, thereby leaving only the flexible paddle electrode at the target position. In addition, the distal end of the first guidewire is always contained within the lumen of the flexible traction tube. During the delivery phase, the flexible paddle electrode can be stably tractioned, and potential damage to the tissue by the tip of the first guidewire can be avoided. Once in place, the fixation can be released and the flexible traction tube can be retrieved simply by pulling back the first guidewire from the proximal end. Attached Figure Description

[0038] In drawings that are not necessarily drawn to scale, the same reference numerals may describe similar parts in different views. The drawings generally illustrate various embodiments by way of example rather than limitation and are used, together with the description and claims, to illustrate the disclosed embodiments. Where appropriate, the same reference numerals are used in all drawings to refer to the same or similar parts. Such embodiments are illustrative and not intended to be exhaustive or exclusive embodiments of the apparatus or method.

[0039] Figure 1 This is an exploded view of the flexible electrode implantation assembly according to an embodiment of this application;

[0040] Figure 2 This is a schematic diagram of the structure of the flexible paddle-shaped electrode of the flexible electrode implantation assembly according to an embodiment of this application;

[0041] Figure 3 This is a schematic diagram of the structure of the distal contact portion of the flexible paddle-shaped electrode in the flexible electrode implantation assembly of this application embodiment;

[0042] Figure 4 This is a schematic diagram of the proximal contact portion of the flexible paddle-shaped electrode in the flexible electrode implantation assembly of this application embodiment;

[0043] Figure 5 This is a schematic diagram of the structure of the flexible electrode implantation assembly according to an embodiment of this application;

[0044] Figure 6 This is a magnified view of a partial structure of the flexible electrode implantation assembly according to an embodiment of this application;

[0045] Figure 7 This is an exploded view of the flexible electrode implantation assembly according to an embodiment of this application, showing a second guidewire and a positioning guide sheath;

[0046] Figure 8 This is a cross-sectional view of the internal structure of the flexible electrode implantation assembly according to an embodiment of this application;

[0047] Figure 9 This is a schematic diagram illustrating the process of implanting a flexible paddle-shaped electrode into a positioning guide sheath according to an embodiment of this application;

[0048] Figure 10 for Figure 9 Enlarged view of a local structure in the middle;

[0049] Figure 11 This is a structural block diagram of a temporary neurostimulator system according to an embodiment of this application;

[0050] Figure 12 This is a structural block diagram of an implantable neurostimulator system according to an embodiment of this application.

[0051] The components indicated by the reference numerals in the figure:

[0052] 100. Flexible paddle-shaped electrode; 110. Proximal contact portion; 111. Proximal interface contact; 120. Lead wire connection portion; 130. Distal contact portion; 131. Electrode contact; 140. Auxiliary fixing portion; 141. Through connection hole; 142. Exit hole body; 143. Insertion hole body; 150. First insulating layer; 160. Conductive layer; 170. Second insulating layer; 180. Deformation guide portion; 190. Second imaging mark; 200. Flexible traction tube; 201 1. Tip structure; 210. Distal exit; 220. Distal inlet; 240. First imaging marker; 300. First guidewire; 400. Second guidewire; 500. Positioning guide sheath; 510. Proximal opening; 520. Distal opening; 521. Spike-like structure; 522. Curved structure; 530. Flaring structure; 1. Flexible electrode implantation assembly; 2. Temporary neurostimulator system; 3. External stimulator; 4. Implantable neurostimulator system; 5. Implantable stimulator. Detailed Implementation

[0053] To enable those skilled in the art to better understand the technical solutions of this application, the application will be described in detail below with reference to the accompanying drawings and specific embodiments. The embodiments of this application will be further described in detail below with reference to the accompanying drawings and specific examples, but these are not intended to limit the scope of this application.

[0054] The terms "first," "second," and similar words used in this application do not indicate any order, quantity, or importance, but are merely used to distinguish different parts. Words such as "including" or "contains" mean that the element preceding the word encompasses the element listed after it, and do not exclude the possibility of encompassing other elements as well. Terms such as "above," "below," "left," and "right" are used only to indicate relative positional relationships; when the absolute position of the described object changes, this relative positional relationship may also change accordingly.

[0055] In this application, when a specific device is described as being located between a first device and a second device, an intermediary device may or may not be present between the specific device and the first or second device. When a specific device is described as being connected to other devices, the specific device may be directly connected to the other devices without an intermediary device, or it may not be directly connected to the other devices but may have an intermediary device.

[0056] All terms used in this application (including technical or scientific terms) have the same meaning as understood by one of ordinary skill in the art to which this application pertains, unless otherwise specifically defined. It should also be understood that terms defined in general dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and not as having an idealized or highly formalized meaning, unless expressly defined herein.

[0057] 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.

[0058] In this application, the term "proximal" is intended to refer to the end closer to the operator (e.g., a physician) performing the implantation procedure, while the term "distal" is intended to refer to the side closer to the target location of the flexible paddle electrode 100 to be implanted.

[0059] This application provides a flexible electrode implantation assembly 1. For example... Figures 1 to 6As shown, the flexible electrode implantation assembly 1 includes a flexible paddle electrode 100, a flexible traction tube 200, and a first guidewire 300. The flexible paddle electrode 100 includes a proximal contact portion 110, a lead wire connection portion 120, and a distal contact portion 130 connected sequentially along the length of the flexible paddle electrode 100. The distal contact portion 130 includes at least one electrode contact 131 for applying electrical stimulation to tissue at a target location and / or acquiring potential signals. The distal contact portion 130 is provided with an auxiliary fixation portion 140. The flexible traction tube 200 has a paired distal outlet 210 and distal inlet 220 on its wall. The flexible paddle electrode 100 is located outside the flexible traction tube 200, and the auxiliary fixation portion 140 covers the tube wall area between the distal outlet 210 and the distal inlet 220. The first guidewire 300 is movably inserted into the lumen of the flexible traction tube 200. The distal end of the first guidewire 300 passes through the distal outlet 210 and connects to the auxiliary fixation part 140, and then passes back into the lumen through the distal inlet 220, thereby forming a detachable traction ring on the outside of the flexible traction tube 200 to constrain the auxiliary fixation part 140 to the outer wall of the flexible traction tube 200, so as to traction the distal contact part 130 of the flexible paddle electrode 100 to be implanted into the target position via the flexible traction tube 200. The target area where the target position is located includes, but is not limited to, the epidural space of the spinal cord, peripheral nerves, and intracranial / extracranial nerves.

[0060] The flexible paddle electrode 100 described above uses a flexible material with good conductivity and biocompatibility, ensuring stable operation of the flexible paddle electrode 100 over a long period of time. It also possesses a certain degree of flexibility, allowing it to deform with the movement of human tissue after implantation. Of course, the flexible paddle electrode 100 can be made of metallic materials, non-metallic materials, or a combination of both. This application does not specifically limit the material used in the flexible paddle electrode 100.

[0061] The flexible paddle electrode 100 can be in the shape of a long strip. The proximal contact portion 110, the lead wire connection portion 120 and the distal contact portion 130 are connected sequentially along the length of the flexible paddle electrode 100. The proximal contact portion 110, the lead wire connection portion and the distal contact portion 130 are all in the shape of long strips. The auxiliary fixing portion 140 provided on the distal contact portion 130 can be constructed as a hole structure or a groove structure.

[0062] The aforementioned proximal contact portion 110 may include a proximal interface contact 111. The electrode contact 131 of the distal contact portion 130 may be electrically connected to the proximal interface contact 111 of the proximal contact portion 110 via the lead wire connection portion 120. The electrode contact 131 may be used to apply electrical stimulation to the tissue at the target location, or to collect the potential signal of the tissue at the target location. The number of electrode contacts 131 may be determined according to the required electrical stimulation coverage and the resolution of the recorded signal to ensure its functionality in various application scenarios.

[0063] The width of the lead wire connection 120 can vary at different positions, and its structural design is specifically a layered design, that is, it is formed by multiple layers of stacked structures.

[0064] The aforementioned flexible traction tube 200 can be understood as having an internal hollow structure, with a pair of distal outlets 210 and distal inlets 220 arranged on its tube wall, both of which are connected to its cavity. When the flexible paddle electrode 100 is fixed to the outside of the flexible traction tube 200, the flexible traction tube 200 can pull the flexible paddle electrode 100 to the target position. When the distal contact portion 130 of the flexible paddle electrode 100 reaches the target position, the first guide wire 300 is pulled proximally to disengage it from the auxiliary fixing portion 140, thereby releasing the fixation between the flexible paddle electrode 100 and the flexible traction tube 200 and retrieving the flexible traction tube 200, leaving the distal contact portion 130 at the target position.

[0065] The aforementioned flexible traction tube 200 can be made of flexible material. Furthermore, the hardness of the proximal end of the flexible traction tube 200 can be greater than that of the distal end, so that the proximal end (i.e., the external operating end) of the flexible traction tube 200 can provide pushing and bending resistance support, while the distal end of the flexible traction tube 200 can have compliance and safety within the body.

[0066] For example, the proximal end of the flexible traction tube 200 is made of a material with higher hardness, such as TPU A80–A90 (thermoplastic polyurethane with a hardness range between Shore A 80 and Shore A 90), while the distal end is made of a material with lower hardness, such as TPU A60–A70 (thermoplastic polyurethane with a hardness range between Shore A 60 and Shore A 70). The length of the hardness transition zone between the proximal and distal ends of the flexible traction tube 200 can be 30mm to 50mm, specifically using a linear gradient or nested co-extrusion method. This ensures both the pushing force and flexural strength of the proximal end of the flexible traction tube 200, and the compliance and safety of the distal end.

[0067] The fact that the distal end of the first guide wire 300 passes through the distal outlet 210 and returns to the lumen through the distal inlet 220 can be understood as the first guide wire 300 forming a detachable traction ring that can pull the flexible paddle electrode 100. In this way, the first guide wire 300 can effectively limit the distal contact portion 130 of the flexible paddle electrode 100 through the actions of passing through and entering. Furthermore, the way the first guide wire 300 passes through the distal outlet 210 and returns to the distal inlet 220 can make the flexible paddle electrode 100 flat and reliably attached to the outer wall of the flexible traction tube 200.

[0068] The distal end of the first guidewire 300 is kept hidden within the lumen of the flexible traction tube 200 during traction, which can effectively avoid potential damage to the tissue by the distal end of the first guidewire 300.

[0069] The first guidewire 300 can be made of any of the following materials: nickel-titanium, 304 stainless steel, or 316L stainless steel. The cross-sectional diameter of the first guidewire 300 can be between 0.15 mm and 0.25 mm. The first guidewire 300, by passing through the distal outlet 210 and returning to the distal inlet 220, can apply a traction force of ≥0.2 N to the flexible paddle electrode 100, allowing the flexible paddle electrode 100 to be stably implanted under the traction force. Especially in scenarios using the positioning guide sheath 500 (described below), the flexible paddle electrode 100, under the traction of the first guidewire 300 and the flexible traction tube 200, can effectively overcome the frictional force within the positioning guide sheath 500, ensuring effective delivery of the flexible paddle electrode 100. In this way, without increasing the size of the percutaneous puncture pathway, the flexible paddle electrode 100 can be stably advanced and oriented through the first guidewire 300 and the flexible traction tube 200, thereby ensuring the accuracy of implantation.

[0070] The cross-section of the aforementioned flexible traction tube 200 can be circular, elliptical, or other shapes to provide good passageability, visibility, and uniform stress distribution. The cross-section of the flexible traction tube 200 can be irregular, such as a racetrack-shaped cross-section, which has a flat central portion and curved edges; that is, the two ends of the racetrack-shaped cross-section are semicircular, and the sides are straight. A circular cross-section of the flexible traction tube 200 offers advantages such as reduced friction and ease of manufacturing. An elliptical cross-section of the flexible traction tube 200 can maintain the cavity area while reducing the external dimensions in a certain direction, which is beneficial for reducing the size of the percutaneous puncture passage. Under a given width constraint, the racetrack-shaped cross-section can provide a larger effective cavity area and higher circumferential anti-collapse capability. Furthermore, the paired distal outlet 210 and distal inlet 220 on the tube wall can reduce stress concentration and the attenuation of the tube wall strength of the flexible traction tube 200, thereby improving the stability of the detachable traction ring and the structural margin for arranging multiple detachable traction rings.

[0071] For example, when the cross-section of the flexible traction tube 200 is circular, the outer diameter of the cross-section can range from 1.5 mm to 3.5 mm, and the inner diameter can range from 0.8 mm to 3.0 mm; when the cross-section of the flexible traction tube 200 is elliptical, the length of the major axis of the elliptical cross-section is 1.1 to 1.5 times the length of the minor axis; when the cross-section of the flexible traction tube 200 is racetrack-shaped, the radii at both ends of the racetrack-shaped cross-section are 0.4 to 0.8 times the width of the short side, and the length of the straight side section accounts for 30% to 60% of the total perimeter of the racetrack-shaped cross-section.

[0072] The distal end of the first guide wire 300 of this application can pass through the distal outlet 210 on the flexible traction tube 200 and connect with the auxiliary fixing part 140, and pass back into the tube cavity through the distal inlet 220, thereby forming a detachable traction ring part outside the flexible traction tube 200 to constrain the auxiliary fixing part 140 to the outer wall of the flexible traction tube 200. This enables reliable delivery of the flexible paddle electrode 100 through the flexible traction tube 200 and the first guide wire 300. The distal end of the flexible paddle electrode 100 is attached to the outer wall of the flexible traction tube 200, which can effectively solve the problem of inaccurate implantation to the target position due to the size of the flexible paddle electrode 100 itself. Furthermore, the first guide wire 300 can achieve controllable release and rapid decoupling of the flexible paddle electrode 100, and has detachability and robustness. It can ensure reliable axial linkage during the delivery stage and quickly release the fixation of the flexible paddle electrode 100 after implantation to the target position, thereby leaving only the flexible paddle electrode 100 at the target position. In addition, the distal end of the first guidewire 300 is always housed within the lumen of the flexible traction tube 200. During the delivery phase, the flexible paddle electrode 100 can be stably tractioned, and potential damage to the tissue by the distal end of the first guidewire 300 can be avoided. Once in place, the fixation can be released and the flexible traction tube 200 can be retrieved simply by pulling back the proximal end of the first guidewire 300.

[0073] In some embodiments, such as Figure 5 and Figure 6 As shown, there are multiple auxiliary fixing parts 140, and the multiple auxiliary fixing parts 140 are arranged at least at intervals along the length direction of the flexible paddle electrode 100.

[0074] In this way, the connection stability between the first guide wire 300 and the flexible paddle electrode 100 can be improved by multiple auxiliary fixing parts 140, and the relative slippage during the delivery process can be effectively suppressed.

[0075] When there are multiple auxiliary fixing parts 140, the first guide wire 300 can be connected to each of the auxiliary fixing parts 140 in sequence, so that the first guide wire 300 can perform distributed constraint on the flexible paddle electrode 100 at different positions of the flexible paddle electrode 100, thereby ensuring the stable positioning of the flexible paddle electrode 100 by the first guide wire 300.

[0076] For example, two to four auxiliary fixing parts 140 are provided along the length direction of the flexible paddle electrode 100 to distribute the axial load as evenly as possible. The multi-point connection between the auxiliary fixing parts 140 and the first guide wire 300 can significantly suppress the slippage and warping of the flexible paddle electrode 100 relative to the flexible traction tube 200 in long-distance propulsion or complex curved paths, so as to reduce the yaw problem that may occur when the flexible paddle electrode 100 is being pulled.

[0077] The aforementioned auxiliary fixing parts 140 can be arranged in an array, that is, the auxiliary fixing parts 140 are not only spaced apart along the length direction of the flexible paddle electrode 100, but also spaced apart along the width direction of the flexible paddle electrode 100. The first guide wire 300 can be connected to each of the auxiliary fixing parts 140 in sequence, thereby further ensuring the installation stability of the first guide wire 300 and the flexible paddle electrode 100.

[0078] In some embodiments, such as Figure 5 and Figure 6 As shown, the flexible traction tube 200 has multiple pairs of distal outlets 210 and distal inlets 220 arranged sequentially on its tube wall. The multiple pairs of distal outlets 210 and distal inlets 220 are arranged in a one-to-one correspondence with multiple auxiliary fixing parts 140.

[0079] In this way, multiple detachable traction rings can be formed by multiple pairs of distal outlets 210 and distal inlets 220, so that the first guide wire 300 passes through each pair of distal outlets 210 and distal inlets 220 in sequence, thereby achieving stable constraint of the flexible paddle electrode 100 and effectively improving connection stability.

[0080] In some embodiments, the first guide wire 300 passes sequentially through each pair of distal outlets 210, the corresponding auxiliary fixing portion 140 and the corresponding distal inlet 220 to form a plurality of detachable traction ring portions in the length direction of the flexible traction tube 200, thereby attaching and constraining the distal contact portion 130 of the flexible paddle electrode 100 to the outer wall of the flexible traction tube 200.

[0081] Understandably, after the first guide wire 300 passes through the distal outlet 210 of one pair, it can be connected to the auxiliary fixing part 140 on the flexible paddle electrode 100. After connection, it passes back into the tube through the distal inlet 220 of the pair, and then passes out through the distal outlet 210 of the next pair. After connecting with the auxiliary fixing part 140, it passes back into the tube through the distal inlet 220 of the pair again. This process is repeated multiple times through each pair of distal outlets 210 and distal inlets 220, so that the distal end of the flexible paddle electrode 100 can be stably attached to the outer wall of the flexible traction tube 200 by the first guide wire 300.

[0082] The spacing between multiple pairs of remote outlets 210 and remote inlets 220 ranges from 10mm to 40mm.

[0083] In some embodiments, the first guide wire 300 may be one or more, to adapt to a scheme where a single detachable traction ring or multiple detachable traction rings are connected to the flexible paddle electrode 100. When the first guide wire 300 is a single wire, the single wire can be connected in series to form a detachable traction ring; when the first guide wire 300 is multiple wires, the multiple wires can each form a detachable traction ring to facilitate stable connection with the flexible paddle electrode 100.

[0084] For scenarios with multiple guidewires, the cross-sectional diameter of a single guidewire can range from 0.12mm to 0.18mm to reduce the total cross-sectional area of ​​the first guidewire 300, thereby reducing friction between guidewires.

[0085] In some embodiments, the proximal end of the flexible traction tube 200 is provided with a proximal outlet and a proximal inlet (not shown in the figure). The proximal end of the first guide wire 300 passes through the proximal outlet and is connected to the proximal contact portion 110, and passes back into the lumen through the proximal inlet, so that the proximal end of the flexible paddle electrode 100 is flatly attached to the outer wall of the flexible traction tube 200.

[0086] In this way, a stable connection between the flexible traction tube 200 and the proximal contact portion 110 can be ensured through the proximal outlet and proximal inlet, so as to achieve stable control of the proximal contact portion 110 through the flexible traction tube 200, thereby improving the implantation reliability.

[0087] An auxiliary connection portion may be provided on the aforementioned proximal contact portion 110. After the proximal end of the first guide wire 300 passes through the proximal outlet, it can be connected to the auxiliary connection portion and then pass back into the lumen through the proximal inlet after connection.

[0088] The aforementioned auxiliary connection can be constructed as a hole structure or a groove structure.

[0089] The aforementioned proximal outlet and proximal inlet can be arranged in pairs, and the proximal end of the flexible traction tube 200 is provided with multiple pairs of proximal outlets and proximal inlets in sequence. The proximal end of the first guide wire 300 can pass through each pair of proximal outlets and proximal inlets in sequence to further ensure a stable connection between the flexible traction tube 200 and the proximal contact portion 110.

[0090] In some embodiments, such as Figure 2 , Figure 5 and Figure 6 As shown, the auxiliary fixing part 140 is a through connection hole 141. The distal end of the first guide wire 300 passes through the through connection hole 141 to connect with the auxiliary fixing part 140, so that a detachable traction ring is formed between the first guide wire 300 and the auxiliary fixing part 140.

[0091] Thus, the first guide wire 300 can be stably connected to the auxiliary fixing part 140 by passing the first guide wire 300 through the through connection hole 141. The connection method between the auxiliary fixing part 140 and the first guide wire 300 facilitates the connection and detachable engagement between the two, which can stably pull the flexible paddle electrode 100 and also eliminate the need for the flexible paddle electrode 100 to be permanently attached to the flexible traction tube 200.

[0092] The aforementioned through-hole 141 is preferably located on the central axis of the distal contact portion 130 or at a position ±0.5 mm from the central axis of the distal contact portion 130. The diameter of the through-hole 141 ranges from 0.3 mm to 1 mm, and the edge of the through-hole 141 can be designed with a rounded radius of 50 μm to 150 μm to disperse stress and prevent cracks from forming in the first insulating layer 150 and the second insulation layer described below.

[0093] The aforementioned through connection hole 141 can be understood as being located at the farthest end of the flexible paddle electrode 100. The first guide wire 300 smoothly mounts and pulls the flexible paddle electrode 100 from the farthest end of the flexible paddle electrode 100, thereby enabling the flexible paddle electrode 100 to achieve stable deflection under the drive.

[0094] In some embodiments, such as Figure 2 and Figure 3 As shown, the through connection hole 141 of the auxiliary fixing part 140 is located at the farthest end of the flexible paddle electrode 100. The far end of the first guide wire 300 passes through the far end outlet 210, the through connection hole 141 and the far end inlet 220 in sequence back into the cavity of the flexible traction tube 200, so that a detachable traction ring is formed between the first guide wire 300 and the auxiliary fixing part 140.

[0095] The shape of the aforementioned through-hole 141 can be circular, elliptical, polygonal, or any combination of the above shapes, to take into account the advantages of processing feasibility, smooth force distribution, and local stress dispersion. Among them, in addition to circular, elliptical through-hole 141 can provide lower tangential stress in the drawing direction, while polygonal through-hole 141 (such as hexagonal) facilitates laser micromachining and positioning. Through-hole 141 of different shapes or combinations thereof can be adapted to different diameters of the first guide wire 300 and the orientation of the detachable traction ring, which can reduce wear on the hole edge.

[0096] In some embodiments, the through connection hole 141 of the auxiliary fixing part 140 includes a pair of through-hole bodies 142 and through-hole bodies 143. The distal end of the first guide wire 300 passes through the distal outlet 210, through-hole body 142, through-hole body 143 and distal inlet 220 in sequence back into the cavity of the flexible traction tube 200, so that a detachable traction ring is formed between the first guide wire 300 and the auxiliary fixing part 140.

[0097] In this way, the connection stability between the auxiliary fixing part 140 and the first guide wire 300 can be further improved by the pair of through holes 142 and through holes 143.

[0098] The spacing between the paired through-hole bodies 142 and through-hole bodies 143 can range from 0.6 mm to 2 mm, which facilitates better control of the edge of the wide flexible paddle electrode 100.

[0099] In some embodiments, there are multiple pairs of exit holes 142 and inlets 143, and the first guide wire 300 passes through each pair of exit holes 142 and inlets 143 in sequence.

[0100] In this way, the connection stability between the auxiliary fixation part 140 and the first guide wire 300 can be further improved by multiple pairs of through holes 142 and through holes 143, thereby forming multiple detachable traction rings in the length direction of the flexible traction tube 200, and attaching and constraining the distal contact part 130 of the flexible paddle electrode 100 to the outer wall of the flexible traction tube 200 to prevent the flexible paddle electrode 100 from deflecting or twisting relative to the axis of the flexible traction tube 200 during implantation.

[0101] In some embodiments, when there are multiple pairs of exit holes 142 and insertion holes 143, the insertion hole 143 in the farthest pair of exit holes 142 and insertion holes 143 may not be provided. After the distal end of the first guidewire 300 passes through the exit hole 142 in this pair, it can be directly returned to the lumen of the flexible traction tube 200 through the distal inlet 220. Specifically, it can be combined with Figure 6 The figure shows three pairs of exit holes 142 and entry holes 143. The entry hole 143 in the farthest pair is not provided. The far end of the first guidewire 300 passes through the far end outlet 210 of the first pair, the exit holes 142 of the first pair, the entry holes 143 of the first pair, the far end inlet 220 of the first pair, the far end outlet 210 of the second pair, the exit holes 142 of the second pair, the entry holes 143 of the second pair, the far end inlet 220 of the second pair, the far end outlet 210 of the third pair, the exit holes 142 of the third pair, the entry holes 143 of the second pair, the far end inlet 220 of the third pair, the far end outlet 210 of the third pair, the exit holes 142 of the third pair, and the far end inlet 220 of the third pair back into the lumen.

[0102] In some embodiments, such as Figures 7 to 9 As shown, the flexible electrode implantation assembly 1 also includes a second guide wire 400, which is disposed in the lumen of the flexible traction tube 200 and is used to provide axial support force to the flexible traction tube 200.

[0103] In this way, by setting the second guide wire 400, a stable axial support force can be provided to the flexible traction tube 200, so that the flexible traction tube 200 can have sufficient axial support force and bending resistance. Especially for long-path scenarios, the flexible traction tube 200 can be pushed forward smoothly and controllably.

[0104] The diameter of the second guide wire 400 can range from 0.35 mm to 0.8 mm, and the material can be ultra-elastic nickel-titanium or high-elastic stainless steel.

[0105] After the distal contact portion 130 of the flexible paddle electrode 100 is implanted into the target position, the operator can pull the first guide wire 300 at the proximal end to disconnect the first guide wire 300 from the auxiliary fixation portion 140, and then retrieve the flexible traction tube 200, the first guide wire 300 and the second guide wire 400, so that only the flexible paddle electrode 100 remains at the target position.

[0106] In some embodiments, the bending stiffness of the second guidewire 400 is greater than that of the first guidewire 300.

[0107] In this way, by limiting the bending stiffness, the second guide wire 400 can undertake the main support and orientation functions during the conveying stage, while the first guide wire 300 can ensure the formation of a detachable traction ring to stably limit the position of the flexible paddle electrode 100.

[0108] The ratio of the bending stiffness of the second guide wire 400 to that of the first guide wire 300 can be greater than or equal to 2:1, thereby ensuring that the second guide wire 400 dominates the support during the conveying stage.

[0109] In some embodiments, the proximal end of the first guidewire 300 is connected to the proximal end of the second guidewire 400 so that the first guidewire 300 can move synchronously along the length direction of the second guidewire 400 via the second guidewire 400.

[0110] Thus, by fixing the proximal end of the first guidewire 300 to the proximal end of the second guidewire 400, the first guidewire 300 and the second guidewire 400 can move synchronously along their length direction during advance and retraction, which facilitates the coordinated control of the first guidewire 300 and the second guidewire 400 during proximal operation.

[0111] The proximal connection of the first guide wire 300 and the second guide wire 400 can be achieved by crimping or laser welding, so that the first guide wire 300 and the second guide wire 400 move synchronously during advance and retraction, reducing the possibility of wire tangling and misoperation.

[0112] In some embodiments, such as Figures 7 to 10As shown, the flexible electrode implantation assembly 1 also includes a positioning guide sheath 500, which has an inner cavity extending through both ends. The inner cavity of the positioning guide sheath 500 is used to accommodate the flexible paddle electrode 100 and the flexible traction tube 200, providing a percutaneous puncture pathway for the flexible paddle electrode 100 and the flexible traction tube 200. It should be noted that after the flexible paddle electrode 100 is pulled through the positioning guide sheath 500, the flexible traction tube 200 can continue to pull the flexible paddle electrode 100 to the target position.

[0113] Thus, the positioning guide sheath 500 can provide a stable percutaneous puncture path for the implantation of the flexible paddle electrode 100, which not only ensures accurate positioning during the implantation of the flexible paddle electrode 100, but also effectively reduces the risks and discomfort during the puncture process. By guiding the flexible paddle electrode 100 to accurately enter the target position along the predetermined path, the positioning guide sheath 500 has the advantages of low incision and low displacement, thereby providing a controllable operating environment for implantation and improving the success rate of implantation.

[0114] The aforementioned flexible electrode implantation component 1 enables the flexible paddle electrode 100 to be delivered and deployed in sequence through coiling and shrinking, insertion into the sheath, deflection and withdrawal from the sheath, flattening and unfolding, and moving forward against the wall, without additional enlarging of the wound.

[0115] The aforementioned flexible paddle electrode 100 is attached to the outer wall of the flexible traction tube 200 and extends into the inner cavity of the positioning guide sheath 500. This allows for reliable delivery, controllable release, and rapid decoupling of the flexible paddle electrode 100 without increasing the size of the percutaneous puncture pathway.

[0116] The thickness of the aforementioned flexible paddle electrode 100 can range from 10 micrometers to 1 millimeter, covering different thickness ranges from ultra-thin flexibility to high support, so that the flexible paddle electrode 100 can both curl into the positioning guide sheath 500 and maintain stability against the outer wall of the flexible traction tube 200 after unfolding.

[0117] The aforementioned positioning guide sheath 500 has a proximal opening 510 and a distal opening 520. The inner cavity size of the positioning guide sheath 500 is suitable for accommodating the flexible traction tube 200, that is, the inner cavity size of the positioning guide sheath 500 is larger than the outer wall size of the flexible traction tube 200, and the gap between the two should be suitable for accommodating the flexible paddle electrode 100.

[0118] The aforementioned positioning guide sheath 500 is a rigid structure to provide the necessary shape retention and pointing accuracy during percutaneous puncture pathway establishment and targeting. Specifically, the positioning guide sheath 500 can be made of one of the following materials: 304L stainless steel, 316L stainless steel, nickel-titanium, and reinforced polymer materials. Thus, the rigid structure of the positioning guide pin and the flexible structure of the flexible traction tube 200 can simultaneously establish a stable percutaneous puncture pathway and increase the structural compliance during the traction phase.

[0119] The outer diameter of the aforementioned positioning guide sheath 500 ranges from 2 mm to 6 mm, the inner diameter ranges from 1.6 mm to 5 mm, and the effective length ranges from 80 mm to 150 mm. The proximal opening 510 and the distal opening 520 of the positioning guide sheath 500 are both deburred and mirror polished. The inner surface roughness of the positioning guide sheath 500 is ≤0.1 μm, in order to establish a stable and low-friction percutaneous puncture pathway.

[0120] The fit gap between the outer wall of the flexible traction tube 200 and the positioning guide sheath 500 is preferably 0.05mm to 0.3mm, so as to take into account low friction propulsion while minimizing the vibration of the flexible traction tube 200 within the positioning guide sheath 500.

[0121] The center-to-center distance between the adjacent auxiliary fixing parts 140 can range from 10 mm to 40 mm, and the distance between the farthest auxiliary fixing part 140 and the distal edge of the flexible paddle electrode 100 ranges from 1 mm to 3 mm. This ensures that the distal end of the flexible paddle electrode 100 can be subjected to edge force balance when it is removed from the positioning guide sheath 500, and provides sufficient freedom for the distal edge of the flexible paddle electrode 100 to turn, reducing the risk of local tearing.

[0122] In some embodiments, such as Figure 7 and Figure 9 As shown, the distal end face of the positioning guide sheath 500 is spike-shaped, that is, the distal end of the positioning guide sheath 500 has a spike-shaped structure 521.

[0123] In this way, the resistance of the positioning guide sheath 500 when entering the tissue can be reduced by the spiked distal end face, and the deflection of the flexible paddle electrode 100 and the flexible traction tube 200 at the moment of sheath exit provides effective guidance.

[0124] The tilt angle of the distal end face of the positioning guide sheath 500 can be between 15° and 30°, and the distal end face of the positioning guide sheath 500 can form a continuous arc transition of 2mm to 5mm, the radius of curvature of which can be between 1mm and 5mm.

[0125] In some embodiments, such as Figure 7 and Figure 9As shown, a curved structure 522 is formed at the distal end of the positioning guide sheath 500. The opening of the curved structure 522 is set towards the target position so as to guide the movement direction of the flexible paddle electrode 100 and the flexible traction tube 200 after they pass through the positioning guide sheath 500 via the curved structure 522.

[0126] Thus, the bending structure 522 can guide the movement direction of the flexible traction tube 200 and the flexible paddle electrode 100 after they are unsheathed, so that the flexible traction tube 200 and the flexible paddle electrode 100 can deflect and exit the sheath along the bending direction of the bending structure 522.

[0127] The aforementioned curved structure 522 can be understood as a curved structure 522 with a continuous curved transition. That is, the curved structure 522 adopts a smooth and gradual bending method in shape, rather than a sudden or sharp angle change, so that when the flexible traction tube 200 and the flexible paddle electrode 100 pass through the distal opening 520 of the positioning guide sheath 500, the moving direction of the flexible traction tube 200 and the flexible paddle electrode 100 will be deflected in a predetermined manner.

[0128] The continuous bending transition of the aforementioned bending structure 522 from one side to the other along the axis of the positioning guide sheath 500 can be designed as a spatial arc or spline. Specifically, the equivalent radius of curvature of the bending structure 522 can range from 10 mm to 40 mm, and the length of the bending section can range from 5 mm to 20 mm.

[0129] In some embodiments, the width of the distal contact portion 130 of the flexible paddle electrode 100 is greater than the inner diameter of the positioning guide sheath 500; and / or, the width of the distal contact portion 130 of the flexible paddle electrode 100 is less than the inner circumference of the positioning guide sheath 500.

[0130] In this way, the flexible paddle-shaped electrode 100 can pass through the positioning guide sheath 500 in a coiled manner with a reduced diameter, and automatically re-unfold after exiting the sheath, so as to achieve the purpose of paddle-shaped coverage.

[0131] In some embodiments, the flexible paddle electrode 100 has a curled state and a flat state. The flexible paddle electrode 100 is in a curled state along its width direction within the inner cavity of the positioning guide sheath 500. After passing through the positioning guide sheath 500, the flexible paddle electrode 100 unfolds from the curled state to the flat state.

[0132] Thus, through the structural design of the flexible paddle electrode 100 in both curled and flat states, the flexible paddle electrode 100 can be curled up and stored inside the positioning guide sheath 500, thereby reducing the wound caused by the implantation of the flexible paddle electrode 100. Furthermore, after the positioning guide sheath 500 is removed, it can be flattened to achieve the purpose of paddle-shaped coverage.

[0133] Understandably, after the flexible paddle electrode 100 passes through the distal opening 520 of the positioning guide sheath 500, it will automatically return to a planar structure or a basically flat state to be arranged according to the predetermined electrode contacts 131, thereby reducing the problem of uneven charge density caused by local warping of the flexible paddle electrode 100.

[0134] The width of the distal contact portion 130 of the aforementioned flexible paddle electrode 100 is smaller than the circumference of the inner cavity of the positioning guide sheath 500, ensuring that the flexible paddle electrode 100 can pass smoothly through the inner cavity without closing into a full circle when it is rolled up inside the positioning guide sheath 500, effectively reducing the risk of friction and jamming of the flexible paddle electrode 100 inside the positioning guide sheath 500.

[0135] When the inner diameter of the positioning guide sheath 500 is in the range of 3 mm to 4.5 mm, the width of the distal contact portion 130 of the flexible paddle electrode 100 is preferably 6 mm to 12 mm, so that the flexible paddle electrode 100 can automatically re-unfold after being rolled into the sheath and then unrolled.

[0136] When the flexible paddle electrode 100 is pulled to the target position after it is unsheathed, the flexible traction tube 200 can still gently advance the flexible paddle electrode 100 20mm to 80mm in the epidural cavity to achieve precise positioning of the flexible paddle electrode 100.

[0137] In some embodiments, such as Figure 3 and Figure 7 As shown, the distal contact portion 130 of the flexible paddle electrode 100 is provided with at least one deformation guide portion 180, which is used to provide a deformable area for the flexible paddle electrode 100 to bend along its width direction and / or length direction.

[0138] Thus, by setting the deformation guide 180, the flexible paddle electrode 100 can have controlled deformation capability, so that the flexible paddle electrode 100 will deform preferentially in the deformable area during turning and re-extension, thereby reducing the risk of instability, wrinkling and breakage of the flexible paddle electrode 100 and improving the predictability and stability of the flexible paddle electrode 100 turning and sticking to the wall.

[0139] Furthermore, through the passive compliance of the flexible traction tube 200, the detachable and stable mounting of the detachable traction ring formed by the first guide wire 300, and the deformation guidance design of the distal end of the flexible paddle electrode 100, controllable steering, reliable wall adhesion, and rapid release can be achieved in the percutaneous puncture pathway.

[0140] The aforementioned deformation guide 180 can provide a preferred deformation path for the flexible paddle electrode 100 throughout the entire process of curling into the sheath, turning out of the sheath, and re-unfolding and adhering to the wall. Specifically, it can concentrate the arc length difference generated by bending into the deformable area, suppress the random wrinkling and in-plane bulging of the flexible paddle electrode 100, and ensure the stability of the electrode contact 131.

[0141] In some embodiments, such as Figure 3 and Figure 7 As shown, the deformation guide 180 is constructed as a long strip structure, and the length direction of the deformation guide 180 is the same as the length direction of the flexible paddle electrode 100.

[0142] Thus, by setting the length direction of the deformation guide 180 to be the same as the length direction of the flexible paddle electrode 100, the flexible paddle electrode 100 can release the arc length difference required for bending in the length direction, thereby enhancing the bending compliance of the flexible paddle electrode 100.

[0143] The width of the aforementioned deformation guide 180 can range from 70μm to 120μm, and the length can range from 5mm to 30mm. The edges of the deformation guide 180 can be polished, and the elongated structure can provide a reversible gap that can be unfolded and closed, reducing overall bending stress.

[0144] In some embodiments, such as Figure 3 and Figure 7 As shown, the deformation guide 180 is a slit structure that penetrates the thickness direction of the flexible paddle electrode 100, so as to better guide the flexible paddle electrode 100 to deform.

[0145] The aforementioned deformation guide 180 particles are conductive structures that do not penetrate the flexible paddle electrode 100, such as the conductive layer 160 described below, to ensure the continuity of electrical function and the integrity of insulation in the deformable region.

[0146] In some embodiments, the deformation guide 180 is a groove provided on the surface of the flexible paddle electrode 100, and the groove is located on the outer side of the flexible paddle electrode 100 when it is bent along its length direction.

[0147] In this way, the flexible paddle electrode 100 can be controlled to bend in the length direction by opening and closing the deformation guide part 180, so that the flexible paddle electrode 100 can pass smoothly through the bending structure 522 at the distal end of the positioning guide sheath 500, and smoothly complete the turning and wall contact after exiting the sheath.

[0148] The aforementioned deformation guide portion 180 is configured as a groove provided along the length direction of the flexible paddle electrode 100, which can provide a controlled deformable area by reducing the local bending stiffness of the flexible paddle electrode 100.

[0149] The aforementioned groove can be understood as a localized thinning structure on the flexible paddle electrode 100, which does not easily penetrate the flexible paddle electrode 100, so as to provide a deformable area that meets the bending requirements while ensuring the structural strength of the flexible paddle electrode 100.

[0150] In some embodiments, such as Figures 1 to 4 As shown, the flexible paddle electrode 100 includes a first insulating layer 150, a conductive layer 160 and a second insulating layer 170 stacked sequentially. A groove is formed on the first insulating layer 150 and / or the second insulating layer 170, and the groove depth is less than the sum of the thicknesses of the first insulating layer 150 and the second insulating layer 170.

[0151] Thus, by setting grooves formed on the first insulating layer 150 and / or the second insulating layer 170, the local bending stiffness of the flexible paddle electrode 100 can be effectively reduced, and the grooves are arranged on the conductive layer 160, so that the flexible paddle electrode 100 can be compliantly bent without exposing the conductive layer 160.

[0152] The aforementioned first insulating layer 150, conductive layer 160, and second insulating layer 170 can be understood as being stacked sequentially in the thickness direction. The flexible paddle electrode 100 employs a three-layer stacked structure of "insulating / conductive / insulating," for example, using polyimide as the material for the first insulating layer 150 and the second insulating layer 170, with optional deposition of parylene as a surface passivation coating on both sides. The conductive layer 160 is made of materials such as platinum, platinum-iridium, or gold, and its wiring and contacts are formed by sputtering and / or electroplating processes. The total thickness of the first insulating layer 150 and the second insulating layer 170 of the flexible paddle electrode 100 is preferably 10 μm to 50 μm (with a single layer thickness of 5 μm to 25 μm), and the thickness of the conductive layer 160 is 0.2 μm to 5 μm.

[0153] The grooves described above may be shallow groove structures etched within the first insulating layer 150 and / or the second insulating layer 170, wherein the depth of the shallow groove structure is less than the sum of the thicknesses of the first insulating layer 150 and the second insulating layer 170.

[0154] In some embodiments, such as Figure 3 As shown, there are multiple deformation guides 180, and the multiple deformation guides 180 are spaced apart along the length direction of the flexible paddle electrode 100; or, there are multiple deformation guides 180, and the multiple deformation guides 180 are spaced apart along the length direction and width direction of the flexible paddle electrode 100.

[0155] Thus, by means of multiple deformation guides 180, segmented or multi-point deformable regions can be formed in the area where the distal contact portion 130 is located, thereby improving the fact that the distal contact portion 130 of the flexible paddle electrode 100 preferentially deforms in the deformable region, and improving the predictability and stability of the flexible paddle electrode 100 when turning and adhering to the wall.

[0156] When the aforementioned plurality of deformation guides 180 are spaced apart along the length direction, the spacing between the plurality of deformation guides 180 can range from 5 mm to 25 mm. Furthermore, the plurality of deformation guides 180 can be arranged in a pattern of denser front and sparser back or in an equidistant pattern according to the expected turning radius, thereby further improving the turning smoothness of the distal contact portion 130 of the flexible paddle electrode 100.

[0157] In some embodiments, such as Figure 7 As shown, the proximal opening 510 of the positioning guide sheath 500 forms a flared structure 530 with an increasing inner diameter from far to near.

[0158] Thus, the design of the flared structure 530 can improve the guidance of the flexible paddle electrode 100 into the positioning guide sheath 500 and reduce propulsion friction, which is conducive to the flexible paddle electrode 100 entering the positioning guide sheath 500.

[0159] The length of the aforementioned flared structure 530 can range from 3mm to 10mm, and the flaring angle can range from 5° to 15°. The flared structure 530 can reduce the difficulty and scratches of accommodating the flexible traction tube 200.

[0160] In some embodiments, such as Figure 9 and Figure 10 As shown, the flexible traction tube 200 has a first imaging mark 240 at a position where the distance between its distal end and the positioning guide sheath 500 is a preset length; and / or, as shown Figure 3 As shown, the distal contact portion 130 of the flexible paddle electrode 100 is provided with a plurality of second imaging marks 190.

[0161] Thus, a first imaging mark 240 is provided on the flexible traction tube 200, and / or a second imaging mark 190 is provided on the distal contact portion 130 of the flexible paddle electrode 100. This allows for rapid identification and positioning of the flexible traction tube 200 and the flexible paddle electrode 100, such as indicating the depth of the flexible traction tube 200 relative to the positioning guide sheath 500 and whether it has penetrated the positioning guide sheath 500, thereby improving the accuracy and efficiency of the operation.

[0162] The aforementioned first imaging mark 240 and / or second imaging mark 190 may specifically be X-ray imaging marks.

[0163] The second imaging marker 190 disposed at the distal end of the aforementioned flexible paddle electrode 100 can form a "grating" effect during fluoroscopy, which can be used to estimate the extent of deployment of the flexible paddle electrode 100 and the coverage of the target tissue during surgery. In postoperative follow-up scenarios, where there are multiple second imaging markers 190, changes in the spacing or relative angle between adjacent second imaging markers 190 can be used to determine whether the flexible paddle electrode 100 has shifted or twisted.

[0164] The aforementioned second development mark 190 may be an asymmetrical structure along the width direction of the flexible paddle electrode 100, used to distinguish the rotational posture of the flexible paddle electrode 100 about the length axis and to indicate the front and back and the left and right edge orientations.

[0165] The aforementioned second imaging marker 190 may be multiple and arranged in an array along the length and / or width direction of the flexible paddle electrode 100, so that the surgeon can determine the orientation of the distal end of the flexible paddle electrode 100 and its posture around the length axis under fluoroscopy.

[0166] The aforementioned second imaging mark 190 can be an asymmetrical imaging structure, such as an offset "F-shape", "L-shape" or eccentric ring pattern. Specifically, the second imaging mark 190 can be asymmetrically distributed along the width direction, thus showing obvious differences under anteroposterior / lateral fluoroscopy. This allows the surgeon to quickly determine the rotational posture of the flexible paddle electrode 100 around its length axis, reducing repeated rotational attempts.

[0167] The aforementioned second imaging markers 190 can be spaced out along the length direction with a spacing of 10mm to 30mm, allowing for real-time observation of the implantation depth of the flexible paddle electrode 100 during the procedure.

[0168] The aforementioned first development mark 240 can be multiple and spaced apart along the length direction to provide multi-point linear references for estimating attitude and displacement. A first development mark 240 can be arranged every 10mm to 30mm along the length direction, thereby forming a linear scale under fluoroscopy to estimate the displacement and attitude changes of the flexible traction tube 200, improving the visualization of remote control.

[0169] The aforementioned first imaging mark 240 is preferably set at a position corresponding to the effective length of the positioning guide sheath 500 at the distal end of the flexible traction tube 200, with an annular visual mark (such as sprayed medical annular ink or embedded tantalum / stainless steel micro ring), and can be superimposed with a millimeter scale band, so that the advancement depth of the flexible traction tube 200 can be quickly judged by naked eye or fluoroscopy during the operation, avoiding excessive advancement or premature release.

[0170] The material of the first developing mark 240 can be tantalum, platinum-iridium or tungsten sheet / wire, and the size of a single first developing mark 240 ranges from 0.3 mm to 1 mm.

[0171] In some embodiments, the lead connection portion 120 of the flexible paddle electrode 100 is provided with a stitching structure (not shown in the figure) on one or both edges in the width direction. The stitching structure is used to pass through the stitches to fix the flexible paddle electrode 100 at the target position.

[0172] In this way, the lead wire connection 120 can be fixed at the target position through the stitching structure, thereby increasing the long-term stability of the flexible paddle electrode 100 at the target position.

[0173] The aforementioned stitching structure can be constructed as a through slit extending along the length of the flexible paddle electrode 100, so that the stitches can pass through and form a linear anchor. This provides high pull-out strength and ease of operation, and avoids the disruption of the conductive path and sudden changes in local stiffness caused by drilling holes in the area where the distal contact portion 130 is located.

[0174] The aforementioned through slit can penetrate the first insulating layer 150 and the second insulating layer 170, but does not pass through the conductive layer 160, to ensure that the suture truly passes through the flexible paddle electrode 100, significantly improving the anchoring strength while avoiding damage to the conductive traces or causing electrochemical leakage and short circuit risks, thus maintaining electrical performance and long-term reliability.

[0175] The aforementioned through-slit can penetrate the first insulating layer 150 and the second insulating layer 170, but does not pass through the conductive layer 160. Laser through-cutting and real-time temperature control can be used to avoid carbonization and burrs in the heat-affected zone, ensuring that the suture passes through the flexible paddle electrode 100 to form a tissue anchor with high pull-out strength.

[0176] The outer edge of the above-mentioned stitching structure shall retain an insulating safety band of ≥0.5mm to 1mm from the outermost wiring to prevent indentation, wear or electrochemical corrosion channels from being created on the wiring during stitching.

[0177] In some embodiments, the width of the distal contact portion 130 of the flexible paddle electrode 100 is greater than the outer diameter of the flexible traction tube 200. This allows the area covered by the unfolded distal contact portion 130 to be significantly larger than the external dimensions of the flexible traction tube 200, which is beneficial for obtaining a larger effective stimulation area or acquisition area.

[0178] When the outer diameter of the flexible traction tube 200 is between 1.3 mm and 3 mm, the distal contact portion 130 should preferably be 3 mm to 12 mm wide, so that the coverage width of the unfolded flexible paddle electrode 100 is greater than or equal to 2 to 4 times the diameter of the flexible traction tube 200. This can significantly expand the effective stimulation area or collection area without increasing the puncture channel and reduce the charge density per unit area.

[0179] In some embodiments, such as Figure 1 and Figure 7As shown, the distal end of the flexible traction tube 200 is a closed, smooth structure 201. This design reduces the risk of tissue damage, allowing the distal end of the flexible traction tube 200 to slide smoothly within the body cavity without generating sharp pressure. Furthermore, throughout the implantation process, the distal ends of the first guidewire 300 and the second guidewire 400 are both placed inside the flexible traction tube 200, effectively preventing the sharp ends of the structure from being exposed and causing pressure or scratches to the dura mater or blood vessels.

[0180] The implantation method based on the above-described flexible electrode implantation component 1 is described below: First, under image guidance, the positioning guide sheath 500 is percutaneously inserted to the target depth, and the spike-like structure 521 of the positioning guide sheath 500 is oriented towards a predetermined deflection direction. The flexible traction tube 200, to which the flexible paddle-shaped electrode 100 is fixed, is inserted into the inner cavity of the positioning guide sheath 500 from the proximal opening 510 and pushed in the distal direction. When the flexible paddle-shaped electrode 100 enters the positioning guide sheath 500, it curls in the width direction and moves forward through the inner cavity of the positioning guide sheath 500 in a curled state, and then exits from the distal opening 520 of the positioning guide sheath 500 and undergoes directional deflection. Further pushing continues until the distal contact portion 130 of the flexible paddle-shaped electrode 100 completely leaves the distal opening 520 of the positioning guide sheath 500 and automatically returns to a planar or substantially flat state. After the flexible paddle electrode 100 reaches the target position, without moving the flexible paddle electrode 100 and the flexible traction tube 200, the positioning guide sheath 500 is pulled out from the proximal end until it is completely withdrawn and separated from the flexible traction tube 200 and the flexible paddle electrode 100. The first guide wire 300 is pulled from the proximal end to release the connection with the auxiliary fixing part 140, thereby releasing the fixation of the flexible paddle electrode 100 and the flexible traction tube 200. Then, the flexible traction tube 200, the first guide wire 300 and the second guide wire 400 are pulled out from the proximal end, and finally the distal contact part 130 of the flexible paddle electrode 100 is left in the target position.

[0181] This application also provides a temporary neurostimulator system 2. For example... Figure 11 As shown, the temporary neurostimulator system 2 includes the flexible electrode implantation assembly 1 of any of the above embodiments, and also includes an external stimulator 3. The external stimulator 3 includes an electrical stimulation circuit and / or a data acquisition circuit, and is detachably connected to the flexible paddle electrode 100. The target area where the target location is located includes, but is not limited to, the epidural space of the spinal cord, peripheral nerves, and intracranial / extracranial nerves.

[0182] The aforementioned external stimulator 3 includes electrical stimulation and / or acquisition circuitry, supporting constant current or constant voltage modes (e.g., supporting 0.1mA to 10mA, 50μs to 1000μs, 2Hz to 2000Hz).

[0183] The aforementioned temporary neurostimulator system 2 may also include electrode connecting wires. The external stimulator 3 is detachably connected to the flexible paddle electrode 100 via the electrode connecting wires, facilitating flexible placement of the surface device and the internal electrode. Preferably, the electrode connecting wires have a multi-core spiral cable structure (e.g., an outer diameter of 2mm to 3mm, silicone insulation, and a length of 1mm to 1.5m), with a built-in shielding braided layer to reduce external electromagnetic interference. The presence of the electrode connecting wires allows for flexible positioning of the external stimulator 3, facilitating postoperative body movement.

[0184] The aforementioned temporary neurostimulator system 2 may also include an electrode extension line with an outer diameter ranging from 2 mm to 3.5 mm. Both ends of the extension line are equipped with detachable medical-grade connectors that are respectively connected to the flexible paddle electrode 100 and the external stimulator 3 to maintain the electrode targeting position while placing the pulse source in a body cavity that is easy to access and maintain surgically, thereby taking into account safety, maintainability and signal integrity.

[0185] The aforementioned temporary neurostimulator system 2 may also include an electrode extension line, which uses a medical silicone sheath and a multi-strand silver / copper alloy conductor, with an outer diameter of 2 mm to 3.5 mm.

[0186] The aforementioned temporary neurostimulator system 2 may further include a protective tube for covering and guiding the lead connection portion 120 of the flexible paddle electrode 100, preventing the lead connection portion 120 from being compressed, rubbed, or entangled within the subcutaneous channel, while providing anti-bending and stress buffering functions to improve the mechanical and electrical stability of long-term implantation. The protective tube may be made of medical-grade silicone or TPU, with an outer diameter of 2mm to 5mm, an inner diameter with a clearance of 0.1mm to 0.5mm between its inner diameter and the outer diameter of the lead connection portion 120, and a length of 5mm to 25cm. The proximal end of the protective tube may be fixedly or detachably connected to the housing interface of the external stimulator 3, and the distal end of the protective tube covers the proximal segment of the lead connection portion 120 of the flexible paddle electrode 100.

[0187] The lead connection portion 120 of the aforementioned flexible paddle electrode 100 is disposed inside the protective tube in a bent shape (e.g., wavy, S-shaped, or serpentine) to form a controllable margin and strain absorption channel, so that the relative displacement of subcutaneous tissue, changes in body position, or respiratory movements is preferentially dissipated in the space inside the protective tube.

[0188] The distal end of the first guidewire 300 of the temporary neurostimulator system 2 using the aforementioned flexible electrode implantation assembly 1 can pass through the distal outlet 210 on the flexible traction tube 200 and connect to the auxiliary fixation part 140, and then pass back into the lumen through the distal inlet 220, thereby forming a detachable traction ring on the outside of the flexible traction tube 200 to constrain the auxiliary fixation part 140 to the outer wall of the flexible traction tube 200. This allows for reliable delivery of the flexible paddle electrode 100 through the flexible traction tube 200 and the first guidewire 300. The distal end of the paddle-shaped electrode 100, when attached to the outer wall of the flexible traction tube 200, effectively solves the problem of inaccurate implantation to the target position due to the size of the flexible paddle-shaped electrode 100 itself. Furthermore, the first guidewire 300 allows for controllable release and rapid decoupling of the flexible paddle-shaped electrode 100, providing both detachability and robustness. This ensures reliable axial linkage during the delivery phase and allows for rapid release of the fixation on the flexible paddle-shaped electrode 100 after implantation at the target position, leaving only the flexible paddle-shaped electrode 100 at the target location. Additionally, the distal end of the first guidewire 300 is always contained within the lumen of the flexible traction tube 200, ensuring stable traction of the flexible paddle-shaped electrode 100 during delivery and preventing potential tissue damage from the distal end of the first guidewire 300. After placement, only proximal retraction of the first guidewire 300 is needed to release the fixation and retrieve the flexible traction tube 200.

[0189] This application also provides an implantable neurostimulator system 4. For example... Figure 12 As shown, the implantable neurostimulator system 4 includes the flexible electrode implantation assembly 1 of any of the above embodiments, and also includes an implantable stimulator 5. The implantable stimulator 5 includes an electrical stimulation circuit and / or a data acquisition circuit, and the implantable stimulator 5 is detachably connected to the flexible paddle electrode 100.

[0190] The aforementioned implantable stimulator 5 is a pulse generator with a titanium alloy shell, which supports rechargeable batteries and transdermal inductive charging. Its output parameters are the same as or wider than those of the external host. Specifically, it can be connected to the flexible paddle electrode 100 via a detachable electrical connection to achieve long-term neural modulation and signal acquisition. This detachable design facilitates the replacement of the pulse source without disturbing the flexible paddle electrode 100.

[0191] The aforementioned implantable neurostimulator system 4 may further include electrode connecting wires. The implantable stimulator 5 is detachably connected to the flexible paddle-shaped electrode 100 via the electrode connecting wires, facilitating flexible placement of the surface device and the internal electrode. Preferably, the electrode connecting wires have a multi-core spiral cable structure (e.g., an outer diameter of 2mm to 3mm, silicone insulation, and a length of 1mm to 1.5m), with an internal shielding braided layer to reduce external electromagnetic interference. The presence of the electrode connecting wires allows for flexible positioning of the implantable stimulator 5, facilitating postoperative body movement.

[0192] The aforementioned implantable neurostimulator system 4 may also include an electrode extension line with an outer diameter ranging from 2 mm to 3.5 mm. Both ends of the extension line are equipped with detachable medical-grade connectors that are respectively connected to the flexible paddle electrode 100 and the implantable stimulator 5. This ensures that the electrode is in the target position while placing the pulse source in a body cavity that is easy to access and maintain during surgery, thereby balancing safety, maintainability, and signal integrity.

[0193] The aforementioned implantable neurostimulator system 4 may also include an electrode extension line, which uses a medical silicone sheath and a multi-strand platinum-iridium alloy conductor, with an outer diameter ranging from 2 mm to 3.5 mm.

[0194] The aforementioned implantable neurostimulator system 4 may further include a protective tube for covering and guiding the lead connection portion 120 of the flexible paddle electrode 100, preventing the lead connection portion 120 from being compressed, rubbed, or entangled within the subcutaneous channel, while providing anti-bending and stress buffering functions to improve the mechanical and electrical stability of long-term implantation. The protective tube may be made of medical-grade silicone or TPU, with an outer diameter of 2mm to 5mm, an inner diameter with a clearance of 0.1mm to 0.5mm between its inner diameter and the outer diameter of the lead connection portion 120, and a length of 5mm to 25cm. The proximal end of the protective tube may be fixedly or detachably connected to the shell interface of the implantable stimulator 5, and the distal end of the protective tube covers the proximal segment of the lead connection portion 120 of the flexible paddle electrode 100.

[0195] The lead connection portion 120 of the aforementioned flexible paddle electrode 100 is disposed inside the protective tube in a bent shape (e.g., wavy, S-shaped, or serpentine) to form a controllable margin and strain absorption channel, so that the relative displacement of subcutaneous tissue, changes in body position, or respiratory movements is preferentially dissipated in the space inside the protective tube.

[0196] The distal end of the first guidewire 300 of the implantable neurostimulator system 4 using the aforementioned flexible electrode implantation assembly 1 can pass through the distal outlet 210 on the flexible traction tube 200 and connect to the auxiliary fixation part 140, and then pass back into the lumen through the distal inlet 220, thereby forming a detachable traction ring on the outside of the flexible traction tube 200 to constrain the auxiliary fixation part 140 to the outer wall of the flexible traction tube 200. This allows for reliable delivery of the flexible paddle electrode 100 through the flexible traction tube 200 and the first guidewire 300. The distal end of the paddle-shaped electrode 100, when attached to the outer wall of the flexible traction tube 200, effectively solves the problem of inaccurate implantation to the target position due to the size of the flexible paddle-shaped electrode 100 itself. Furthermore, the first guidewire 300 allows for controllable release and rapid decoupling of the flexible paddle-shaped electrode 100, providing both detachability and robustness. This ensures reliable axial linkage during the delivery phase and allows for rapid release of the fixation on the flexible paddle-shaped electrode 100 after implantation at the target position, leaving only the flexible paddle-shaped electrode 100 at the target location. Additionally, the distal end of the first guidewire 300 is always contained within the lumen of the flexible traction tube 200, ensuring stable traction of the flexible paddle-shaped electrode 100 during delivery and preventing potential tissue damage from the distal end of the first guidewire 300. After placement, only proximal retraction of the first guidewire 300 is needed to release the fixation and retrieve the flexible traction tube 200.

[0197] Furthermore, although exemplary embodiments have been described herein, their scope includes any and all embodiments based on this application that have equivalent elements, modifications, omissions, combinations (e.g., schemes involving intersections of various embodiments), adaptations, or alterations. Elements in the claims will be interpreted broadly based on the language used in the claims and are not limited to the examples described in this specification or during the implementation of this application, and such examples will be interpreted as non-exclusive.

[0198] The above description is intended to be illustrative and not restrictive. For example, the above examples (or one or more of them) can be used in combination with each other. Other embodiments can be used by those skilled in the art when reading the above description. Furthermore, in the above detailed description, various features may be grouped together to simplify the application. This should not be construed as an intention that a disclosed feature not claimed is necessary for any claim. Rather, the subject matter of the application may be less than all the features of a particular disclosed embodiment. Thus, the claims are incorporated herein by reference as examples or embodiments, wherein each claim is an independent, separate embodiment, and these embodiments are contemplated as being able to be combined with each other in various combinations or arrangements. The scope of this application should be determined by reference to the appended claims and the full scope of their equivalents.

[0199] The above embodiments are merely exemplary embodiments of this application and are not intended to limit this application. The scope of protection of this application is defined by the claims. Those skilled in the art can make various modifications or equivalent substitutions to this application within its substance and scope of protection, and such modifications or equivalent substitutions should also be considered to fall within the scope of protection of this application.

Claims

1. A flexible electrode implantation assembly, characterized in that, include: A flexible paddle electrode includes a proximal contact portion, a lead wire connection portion, and a distal contact portion connected sequentially along the length direction of the flexible paddle electrode. The distal contact portion includes at least one electrode contact for applying electrical stimulation to tissue at a target location and / or acquiring potential signals, and the distal contact portion is provided with an auxiliary fixing portion. A flexible traction tube has a pair of distal outlets and distal inlets on its tube wall. The flexible paddle electrode is located outside the flexible traction tube, and the auxiliary fixing part covers the tube wall area between the distal outlet and the distal inlet. The first guide wire is movably inserted into the lumen of the flexible traction tube. The distal end of the first guide wire passes through the distal outlet and is connected to the auxiliary fixing part. It then passes back into the lumen through the distal inlet, thereby forming a detachable traction ring on the outside of the flexible traction tube to constrain the auxiliary fixing part to the outer wall of the flexible traction tube, so as to pull the distal contact part of the flexible paddle electrode to the target position via the flexible traction tube.

2. The flexible electrode implantation assembly according to claim 1, characterized in that, There are multiple auxiliary fixing parts, and the multiple auxiliary fixing parts are arranged at least at intervals along the length direction of the flexible paddle electrode.

3. The flexible electrode implantation assembly according to claim 2, characterized in that, The flexible traction tube has multiple pairs of distal outlets and distal inlets arranged sequentially on its wall, and each pair of distal outlets and distal inlets is corresponding to one of the multiple auxiliary fixing parts.

4. The flexible electrode implantation assembly according to claim 2 or 3, characterized in that, The first guide wire passes sequentially through each pair of distal outlets, corresponding auxiliary fixing parts, and corresponding distal inlets to form multiple detachable traction rings along the length of the flexible traction tube, thereby fitting and constraining the distal contact portion of the flexible paddle electrode to the outer wall of the flexible traction tube.

5. The flexible electrode implantation assembly according to claim 4, characterized in that, The first guidewire may be one or more.

6. The flexible electrode implantation assembly according to claim 1, characterized in that, The auxiliary fixing part is a through connection hole, and the distal end of the first guide wire passes through the through connection hole to connect with the auxiliary fixing part, so that a detachable traction ring is formed between the first guide wire and the auxiliary fixing part.

7. The flexible electrode implantation assembly according to claim 6, characterized in that, The through-connection hole of the auxiliary fixing part is located at the farthest end of the flexible paddle electrode. The far end of the first guide wire passes through the far end outlet, the through-connection hole and the far end inlet in sequence back into the lumen, so that a detachable traction ring is formed between the first guide wire and the auxiliary fixing part.

8. The flexible electrode implantation assembly according to claim 6, characterized in that, The through connection hole of the auxiliary fixing part includes a pair of through-hole bodies and through-hole bodies. The distal end of the first guide wire passes through the distal outlet, the through-hole body, the through-hole body and the distal inlet in sequence back into the lumen, so that a detachable traction ring is formed between the first guide wire and the auxiliary fixing part.

9. The flexible electrode implantation assembly according to claim 8, characterized in that, There are multiple pairs of exit holes and insertion holes, and the first guide wire passes through each pair of exit holes and insertion holes in sequence.

10. The flexible electrode implantation assembly according to claim 1, characterized in that, The flexible electrode implantation assembly further includes a second guidewire, which is disposed within the lumen of the flexible traction tube and is used to provide axial support force to the flexible traction tube.

11. The flexible electrode implantation assembly according to claim 10, characterized in that, The bending stiffness of the second guidewire is greater than that of the first guidewire.

12. The flexible electrode implantation assembly according to claim 10, characterized in that, The proximal end of the first guidewire is connected to the proximal end of the second guidewire so that the first guidewire is driven to move synchronously along the length direction of the second guidewire via the second guidewire.

13. The flexible electrode implantation assembly according to claim 1, characterized in that, The flexible electrode implantation assembly also includes a positioning guide sheath having an inner cavity extending through both ends thereto, the inner cavity of which is used to accommodate the flexible paddle electrode and the flexible traction tube, thereby providing a percutaneous puncture pathway for the flexible paddle electrode and the flexible traction tube.

14. The flexible electrode implantation assembly according to claim 13, characterized in that, The distal end face of the positioning guide sheath is spike-shaped.

15. The flexible electrode implantation assembly according to claim 13, characterized in that, The distal end of the positioning guide sheath has a curved structure with the opening of the curved structure facing the target position, so as to guide the movement direction of the flexible paddle electrode and the flexible traction tube after they pass through the positioning guide sheath via the curved structure.

16. The flexible electrode implantation assembly according to claim 13, characterized in that, The width of the distal contact portion of the flexible paddle electrode is greater than the inner diameter of the positioning guide sheath; and / or, the width of the distal contact portion of the flexible paddle electrode is less than the inner circumference of the positioning guide sheath.

17. The flexible electrode implantation assembly according to claim 13, characterized in that, The flexible paddle electrode has a curled state and a flat state. The flexible paddle electrode is in the curled state along its width direction inside the cavity of the positioning guide sheath. After passing through the positioning guide sheath, the flexible paddle electrode unfolds from the curled state to the flat state.

18. The flexible electrode implantation assembly according to claim 1, characterized in that, The distal contact portion of the flexible paddle electrode is provided with at least one deformation guide portion, which is used to provide a deformable area for bending of the flexible paddle electrode along its width direction and / or length direction.

19. The flexible electrode implantation assembly according to claim 18, characterized in that, The deformation guide is constructed as a long strip, and the length direction of the deformation guide is the same as the length direction of the flexible paddle electrode.

20. The flexible electrode implantation assembly according to claim 18, characterized in that, The deformation guide is a slit structure that extends through the thickness direction of the flexible paddle electrode.

21. The flexible electrode implantation assembly according to claim 18, characterized in that, The deformation guide is a groove provided on the surface of the flexible paddle electrode, and the groove is located on the outer side of the flexible paddle electrode when it is bent along its length direction.

22. The flexible electrode implantation assembly according to claim 21, characterized in that, The flexible paddle electrode includes a first insulating layer, a conductive layer, and a second insulating layer stacked sequentially. The groove is formed on the first insulating layer and / or the second insulating layer, and the groove depth is less than the sum of the thicknesses of the first insulating layer and the second insulating layer.

23. The flexible electrode implantation assembly according to claim 18, characterized in that, The deformation guide portion is multiple, and the multiple deformation guide portions are spaced apart along the length direction of the flexible paddle electrode; or, There are multiple deformation guides, and the multiple deformation guides are spaced apart along the length and width directions of the flexible paddle electrode.

24. The flexible electrode implantation assembly according to claim 13, characterized in that, The positioning guide sheath has a flared structure with an increasing inner diameter at its proximal opening.

25. The flexible electrode implantation assembly according to claim 13, characterized in that, The flexible traction tube has a first imaging mark at its distal end, at a position where the distance between it and the positioning guide sheath is a preset length; and / or, The distal contact portion of the flexible paddle electrode is provided with multiple second imaging marks.

26. The flexible electrode implantation assembly according to claim 1, characterized in that, The lead connection portion of the flexible paddle electrode has a stitching structure on one or both edges in the width direction. The stitching structure is used to pass through the stitches to fix the flexible paddle electrode at the target position.

27. The flexible electrode implantation assembly according to claim 1, characterized in that, The width of the distal contact portion of the flexible paddle electrode is greater than the outer diameter of the flexible traction tube.

28. The flexible electrode implantation assembly according to claim 1, characterized in that, The distal end of the flexible traction tube has a closed, smooth structure.

29. A temporary neurostimulator system, characterized in that, The device includes a flexible electrode implantation assembly as described in any one of claims 1 to 28, and further includes an external stimulator, the external stimulator including an electrical stimulation circuit and / or a data acquisition circuit, the external stimulator being detachably connected to the flexible paddle electrode.

30. An implantable neurostimulator system, characterized in that, The device includes a flexible electrode implantation assembly as described in any one of claims 1 to 28, and further includes an implantable stimulator, the implantable stimulator including an electrical stimulation circuit and / or a data acquisition circuit, the implantable stimulator being detachably connected to the flexible paddle electrode.

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