Flexible electrode telescopic delivery device and flexible electrode delivery method

Abstract

The present disclosure provides a flexible electrode telescopic delivery device and a flexible electrode delivery method, relates to the technical field of manipulators, in particular to a needle manipulator for surgery, and more particularly to a flexible electrode telescopic delivery device and a flexible electrode delivery method, and the implementation scheme is as follows: the device comprises a sleeve (1), an electrode belt assembly and a driving assembly; the electrode belt assembly is movably arranged in the sleeve in the axial direction and can move between a retracted position accommodated in the sleeve (1) and an extended position extending from the distal end of the sleeve (1), the electrode belt assembly comprises a flexible electrode belt (3) and a puncture member (8) penetrating the front end of the flexible electrode belt; the driving assembly is arranged in the sleeve and connected to the electrode belt assembly, and is used for driving the electrode belt assembly to move relative to the sleeve between the extended position and the retracted position in response to the operation of an operator, so that the flexible electrode belt can extend out of the sleeve (1) with the puncture member (8) and puncture to a target position and retract after delivery is completed.

Description

Technical Field

[0001] This disclosure relates to the field of manipulator technology, specifically to surgical needle manipulators, and more particularly to a flexible electrode telescopic delivery device and a flexible electrode delivery method. Background Technology

[0002] In related technologies, flexible electrodes, due to their good mechanical flexibility and high modulus matching with biological tissues, have been used in long-term recording and closed-loop stimulation of neural electrical signals. However, flexible electrodes themselves lack sufficient axial stiffness, making direct self-puncture implantation difficult. They typically rely on rigid shuttle needles as delivery carriers: the flexible electrode is temporarily fixed to a metal puncture needle, punctured to the target point, and then the needle is withdrawn, leaving the flexible electrode in place. Related delivery methods often employ disposable cannulas, surgical guides, or manually clamped needle-electrode combinations.

[0003] The methods described in this section are not necessarily methods that had been previously conceived or adopted. Unless otherwise specified, no method described in this section should be assumed to be prior art simply because it is included in this section. Similarly, unless otherwise specified, the issues mentioned in this section should not be considered to be accepted in any prior art. Summary of the Invention

[0004] To address the issues of numerous operational steps and low delivery efficiency in the delivery of flexible electrodes in related technologies, this disclosure provides a flexible electrode telescopic delivery device and a flexible electrode delivery method.

[0005] According to one aspect of this disclosure, a flexible electrode telescopic delivery device includes: a cannula, which is an axially extending tubular shell having opposing distal and proximal ends, the distal end constituting an insertion end of the cannula and the proximal end constituting an operating end of the cannula; an electrode band assembly, axially movably disposed within the cannula, the electrode band assembly being movable between a retracted position housed within the cannula and an extended position extending from the distal end of the cannula, the electrode band assembly including a flexible electrode band and a puncture member passing through the front end of the flexible electrode band, the puncture member being used to provide axial stiffness to the flexible electrode band and establish a puncture channel during delivery; and a drive assembly disposed within the cannula and connected to the electrode band assembly, the drive assembly being configured to, in response to an operator's operation, drive the electrode band assembly relative to the cannula to move between the extended and retracted positions, so that the flexible electrode band can extend out of the cannula with the puncture member and puncture to the target location, and retract after delivery. In surgical procedures, the operator can extend the flexible electrode strip from the distal end of the cannula and puncture the target tissue by operating the drive component. After delivery, the electrode strip assembly can be retracted, achieving one-click extension and retraction and single-handed operation, which effectively simplifies the delivery process and improves surgical efficiency.

[0006] In some embodiments, the device further includes an electrode protection device located at the distal end of the cannula. When the electrode band assembly is in the retracted position, the electrode protection device closes the distal opening of the cannula; when the electrode band assembly is in the extended position, the electrode protection device opens the distal opening. In clinical use, when the flexible electrode is in the retracted state, the electrode protection device seals the electrode tip within the cannula, preventing the electrode from bending, becoming contaminated, or getting snagged during transportation, installation, or adjustment. When the electrode needs to be delivered, the electrode band assembly extends and automatically pushes open the protection device, without affecting normal delivery operations. This ensures both safe storage of the electrode and automatic opening during delivery, requiring no additional operation.

[0007] In some embodiments, the electrode protection device is a two-lobed elastic cover. When the electrode strip assembly is in the retracted position, the two lobes are closed; when the electrode strip assembly moves from the retracted position to the extended position, the electrode strip assembly pushes the two lobes open. In a specific structure, the two lobes of the cover always maintain a closed tendency under the action of the elastic element. When the electrode strip assembly extends, it overcomes the elastic force by its own forward movement and pushes the two lobes open. The structure is simple and the linkage is reliable.

[0008] In some embodiments, the drive assembly includes a push rod, a button, and a resilient reset member. The push rod is axially disposed within the cannula, with its distal end connected to the electrode strip assembly. The button is connected to the proximal end of the push rod and is at least partially exposed outside the proximal end of the cannula. The resilient reset member is disposed within the cannula and acts on the push rod, configured to apply a reset force to the push rod to move it from an extended position to a retracted position. In use, the operator presses the button to drive the push rod forward, extending the electrode strip assembly; upon releasing the button, the resilient reset member automatically pushes the push rod back, retracting the electrode strip assembly. This one-button operation method facilitates single-handed operation and is particularly suitable for surgical environments where the operator needs to simultaneously manage other instruments.

[0009] In some embodiments, a resilient reset element is sleeved on the front end of the push rod, with one end of the resilient reset element abutting against a fixing shoulder provided on the inner wall of the sleeve. By placing the reset spring in the narrow space at the front end of the sleeve and arranging it around the push rod, the internal space of the sleeve is fully utilized, making the overall structure of the device compact.

[0010] In some implementations, the flexible electrode strip includes a front end segment and an extension segment, which are integrally connected. In neural signal recording or stimulation applications, the front end segment is implanted into the target tissue, while the extension segment is led out to connect to an external signal processing device. The integral structure eliminates solder joints or connection breaks between the electrode strip and the extension lead in traditional solutions, avoiding signal interruption due to connection failure and improving long-term reliability.

[0011] In some implementations, the front end and the extension are integrally formed from the same flexible insulating substrate. For example, a single flexible film can be used to form a continuous, integral structure through cutting or etching processes, eliminating any physical breaks in the signal transmission path.

[0012] In some embodiments, the flexible insulating substrate is a polyimide film. Polyimide possesses excellent flexibility, insulation, and biocompatibility, meeting the requirements for long-term implantation.

[0013] In some embodiments, the distal end of the front end segment has a perforation through which the puncture member passes, the puncture member being inserted into the perforation with its distal end extending beyond the front end segment. During delivery, the puncture member and the flexible electrode band move forward as a whole. The tip of the puncture member first contacts the tissue and establishes a puncture channel, followed by the flexible electrode band entering the target position. The puncture member provides axial stiffness to the flexible electrode, enabling it to pass smoothly through the tissue without bending.

[0014] In some embodiments, the puncture component is a tungsten needle. Tungsten needles have high hardness and elastic modulus, maintain sufficient axial stiffness even at micro-diameters, and have good biocompatibility, allowing them to withdraw smoothly after puncture guidance is completed.

[0015] In some embodiments, the surface of the front end segment is provided with multiple electrode contacts. These contacts are used to form electrical contact with the target nerve tissue after implantation, so as to realize the acquisition of nerve signals or the application of electrical stimulation.

[0016] In some implementations, the electrode contacts are made of gold or platinum-iridium. Both gold and platinum-iridium have excellent conductivity and corrosion resistance, and can maintain stable electrical properties over long periods in bodily fluid environments.

[0017] In some embodiments, the proximal region of the cannula has an exit opening, and the flexible electrode band has an extension extending from the electrode band assembly towards the proximal end, the extension extending through the exit opening to the outside of the cannula. During the procedure, the extension can be directly connected to the acquisition device after being led out from the proximal end of the cannula, eliminating the need for a lead wire to run from the front end, avoiding traction interference from the implanted site, and facilitating real-time monitoring of signal quality during the procedure.

[0018] In some implementations, the lead-out opening is located on the top wall of the proximal region of the sleeve, and the extension extends upward from the top wall. This lead-out direction ensures that the routing of the extension does not interfere with the operator's grip on the sleeve and button operation.

[0019] In some embodiments, a removable sealing plug is provided at the outlet, which is configured to seal the outlet when not connected to an external device. When no external device connection is required, the sealing plug prevents tissue fluid or contaminants from entering the cannula, keeping the cannula's interior clean.

[0020] In some implementations, the extension extends through an exit opening and connects to an external device, which can be any one of a neural signal acquisition chip, an electrical stimulator, or an adapter interface board. The operator can select the appropriate external device according to the specific surgical needs; for example, connecting the acquisition chip in recording mode and the electrical stimulator in treatment mode.

[0021] In some implementations, the flexible electrode strip is a multi-channel parallel structure, with multiple puncture components corresponding one-to-one with the perforations of the multi-channel parallel structure. For applications requiring multi-point recording or stimulation (e.g., electrocorticometry arrays), the multi-channel parallel structure can complete the simultaneous implantation of multiple electrode channels in a single delivery operation.

[0022] In some embodiments, the sleeve is made of polyetheretherketone, polycarbonate, or titanium alloy. These materials all have good biocompatibility and mechanical strength, and can be selected based on the sterilization method (high-temperature steam sterilization, ethylene oxide sterilization, etc.) and cost requirements.

[0023] According to another aspect of this disclosure, a flexible electrode delivery method is provided, comprising the following steps: a drive assembly, in response to an operator's operation, moves an electrode strip assembly from a retracted position to an extended position; the flexible electrode strip carries a puncture member extending axially from the cannula; the puncture member first contacts the target tissue and establishes a puncture channel; the flexible electrode strip then enters the target tissue; the puncture member is then withdrawn from the flexible electrode strip, and the tip of the flexible electrode strip remains in place and adheres to the target tissue due to friction with the target tissue and its own flexibility. This method achieves integrated operation of electrode delivery and puncture guidance, eliminating the need for pre-placement of guidewires or exchange instruments.

[0024] In some implementations, after the puncture component is withdrawn, an extension of the flexible electrode band is connected to an external device through an exit opening in the proximal region of the cannula. The extension extends from the electrode band assembly toward the proximal end of the cannula. Because the external interface is located at the proximal end of the cannula, the operator can establish a signal acquisition link without interfering with the implantation site.

[0025] In some implementations, the external device is any one of a neural signal acquisition chip, an electrical stimulator, or an adapter board.

[0026] In some implementations, after the electrode band assembly is in the extended position, a drive component moves the electrode band assembly from the extended position to the retracted position to adjust the implantation depth or protect the tip of the indwelling flexible electrode band. In clinical practice, if the initial implantation position is not ideal, the operator can retract and re-extend the electrode band assembly to repeatedly fine-tune the implantation depth until a satisfactory delivery result is achieved.

[0027] It should be understood that the description in this section is not intended to identify key or essential features of the embodiments of this disclosure, nor is it intended to limit the scope of this disclosure. Other features of this disclosure will become readily apparent from the following description. Attached Figure Description

[0028] The accompanying drawings exemplify embodiments and form part of the specification, serving together with the textual description to explain exemplary implementations of the embodiments. The illustrated embodiments are for illustrative purposes only and do not limit the scope of the claims. Throughout the drawings, the same reference numerals refer to similar but not necessarily identical elements.

[0029] The embodiments of this application will now be described in detail with reference to the accompanying drawings, so that those skilled in the art can more clearly understand the above and other features and advantages of this application, in which: Figure 1 A schematic diagram of the transverse structure of a flexible electrode telescopic delivery device, which is an exemplary embodiment of the present disclosure; Figure 2 A longitudinal structural schematic diagram of a flexible electrode telescopic delivery device, which is an exemplary embodiment of the present disclosure; Figure 3 for Figure 1 A partially enlarged schematic diagram illustrating the opening and closing principle of the middle electrode protection device; Figure 4 for Figure 1 A partially enlarged schematic diagram showing the flexible electrode fixed to the tungsten needle through a perforation. Figure 5 for Figure 1 A partially enlarged schematic diagram of the opening at the pressing end of the middle sleeve and the external interface; Figure 6 A flowchart illustrating a flexible electrode delivery method as an exemplary embodiment of this disclosure.

[0030] The markings in the diagram are as follows: 1-Sheath; 2-Electrode protection device; 3-Flexible electrode strip; 31-Front end section; 32-Extension section; 4-Push rod; 5-Elastic reset component; 6-Button; 7-Opening; 8-Piercing component; 11-Perforation; 12-Electrode contact; 13-Sealing plug; 14-Fixing shoulder. Detailed Implementation

[0031] The following descriptions of exemplary embodiments refer to the accompanying drawings. These exemplary embodiments are merely specific implementations of this disclosure and are not intended to limit the scope of this disclosure in any way. Directional terms used in this disclosure, such as "up," "down," "front," "rear," "left," "right," "inner," "outer," and "side," refer only to directions referenced in the accompanying drawings. Therefore, the directional terms used are for illustration and understanding of this disclosure and not for limiting it. In the drawings, structurally similar units are denoted by the same reference numerals. In the drawings, for clarity and ease of description, the dimensions of some components have been exaggerated and / or the structures of some components simplified. That is, the dimensions and structures of each component shown in the drawings are schematic and are not intended to limit the scope of this disclosure.

[0032] In related technologies, when using disposable cannulas, surgical guides, or manually clamped needle-electrode combinations for flexible electrode delivery, delivery and external connection are performed in separate steps. This requires sequentially inserting the needle, placing the electrode, withdrawing the needle, and connecting the interface, resulting in numerous steps, low efficiency, and increased risk of electrode contamination and tissue damage from repeated operations. Flexible electrodes lack effective protective devices before and after delivery, and the exposed electrode tip is prone to bending, contamination, or snagging. Electrode strips and extension leads are often separate connections, resulting in solder joints or connection breaks, leading to poor long-term reliability. External interfaces typically need to be led out separately from the front or rear of the device. Leading out from the front can interfere with the implanted target area, while leading out from the rear is hampered by the button mechanism, making wiring difficult.

[0033] Therefore, this disclosure proposes a flexible electrode telescopic delivery device. (Reference) Figure 1 and Figure 2 The device may include a sleeve 1, an electrode strip assembly, and a drive assembly. The sleeve 1 may be an axially extending tubular shell having a relatively distal end (i.e., Figure 1 The left end (the end closest to the target tissue) and the proximal end (i.e. Figure 1The distal end (the end closest to the operator) can be the insertion end of the cannula 1, while the proximal end can be the operating end of the cannula 1. The electrode band assembly is axially movably disposed within the cannula 1, allowing it to move between a retracted position within the cannula 1 and an extended position extending from the distal end of the cannula 1. The electrode band assembly may include a flexible electrode band 3 and a puncture member 8 passing through the front end of the flexible electrode band 3. In this example, the puncture member 8 can be used to provide axial stiffness to the flexible electrode band 3 and establish a puncture channel during delivery. A drive assembly may be disposed within the cannula 1 and connected to the electrode band assembly, and may be configured (e.g., in response to operator input) to drive the electrode band assembly relative to the cannula 1 between an extended and retracted position. This allows the flexible electrode band 3 to extend from the cannula 1 with the puncture member 8 and puncture to the target location, and then retract after delivery. In surgical procedures, the operator can extend the flexible electrode band from the distal end of the cannula and puncture the target tissue by manipulating the drive component. After delivery, the electrode band assembly can be retracted, achieving one-click extension and retraction and single-handed operation, effectively simplifying the delivery process and improving surgical efficiency. The following is a further detailed description of each component and its additional features with reference to the accompanying drawings.

[0034] Electrode protection device In some implementations, such as Figures 1 to 3 As shown, the device may also include an electrode protection device 2 disposed at the distal end of the sleeve 1. Figure 3 The left side schematically shows the electrode protection device 2 in a closed state to protect the electrode strip assembly. At this time, the electrode strip assembly is retracted, and the electrode protection device 2 seals the sleeve 1 to prevent dust. Figure 3 The right side schematically shows the electrode protection device 2 in the open position, allowing the electrode band assembly to extend. In this position, the electrode band assembly extends along with the puncture component (e.g., a needle). When the electrode band assembly is in the retracted position, the electrode protection device 2 closes the distal opening of the cannula 1; when the electrode band assembly is in the extended position, the electrode protection device 2 opens the distal opening. In clinical use, when the flexible electrode is in the retracted position, the electrode protection device can seal the electrode tip within the cannula, preventing the electrode from bending, becoming contaminated, or getting snagged during transport, installation, or adjustment. When the electrode needs to be delivered, the electrode band assembly extends and automatically pushes open the protection device, without affecting normal delivery operations.

[0035] In some implementations, such as Figure 3As shown, the electrode protection device 2 can be a two-lobed elastic cover. As used herein, when referring to a "two-lobed elastic cover," it can mean a cover structure composed of two lobed components that can open and close under elastic force. When the electrode band assembly is in the retracted position, the two lobes can close under elastic force; when the electrode band assembly moves from the retracted position to the extended position, the electrode band assembly can push the two lobes open. In a specific structure, the two-lobed cover can always maintain a closed tendency under the action of an elastic element (such as a torsion spring or a spring sheet). When the electrode band assembly extends, it overcomes the elastic force by its own forward movement to push the two lobes open. The structure is simple and the linkage is reliable.

[0036] Driver components In some implementations, such as Figure 1 and Figure 2 As shown, the drive assembly may include a push rod 4, a button 6, and a resilient reset member 5. The push rod 4 may be axially disposed within the cannula 1, with its distal end connected to the electrode strip assembly. The button 6 may be connected to the proximal end of the push rod 4, at least partially exposed outside the proximal end of the cannula 1, for operator pressing. The resilient reset member 5 may be disposed within the cannula 1 and act on the push rod 4, configured to apply a reset force to the push rod 4 to move it from the extended position to the retracted position. In use, the operator presses the button to drive the push rod forward, extending the electrode strip assembly; upon releasing the button, the resilient reset member automatically pushes the push rod back, retracting the electrode strip assembly. This one-button operation method facilitates single-handed operation and is particularly suitable for surgical environments where the operator needs to simultaneously manage other instruments.

[0037] In some implementations, such as Figure 1 As shown, the elastic reset member 5 can be sleeved on the front end of the push rod 4, and one end of the elastic reset member 5 can abut against the fixing shoulder 14 provided on the inner wall of the sleeve 1. By setting the elastic reset member in the narrow space at the front end of the sleeve and arranging it around the push rod, the internal space of the sleeve can be fully utilized, making the overall structure of the device compact. In the example, the elastic reset member can be a helical compression spring.

[0038] Flexible electrode strip In some implementations, such as Figure 1 and Figure 4 As shown, the flexible electrode strip 3 may include a front end segment 31 and an extension segment 32, which can be integrally formed and connected. In neural signal recording or stimulation applications, the front end segment is used for implantation into the target tissue, while the extension segment needs to be led out to connect to an external signal processing device. The integrally formed structure eliminates the solder joints or plug-in breaks between the electrode strip and the extension lead in traditional solutions, avoiding signal interruption due to connection failure and improving the reliability of long-term use.

[0039] In some embodiments, the front end segment 31 and the extension segment 32 can be integrally formed from the same flexible insulating substrate. For example, a continuous integral structure can be formed from the same flexible film through cutting or etching processes, so that there are no physical breaks in the signal transmission path.

[0040] In some embodiments, the flexible insulating substrate can be a polyimide film. Polyimide possesses excellent flexibility, insulation, and biocompatibility, meeting the requirements for long-term implantation. It is understood that flexible insulating materials with similar properties, such as parylene, can also be used as alternatives.

[0041] puncture component Figure 4 The illustration schematically shows the perforation fixation of the flexible electrode band and the puncture component. In some embodiments, such as Figure 4 As shown, the distal end of the front end segment 31 may have a perforation 11 for the puncture member to pass through. The puncture member 8 can be inserted into the perforation 11, and the distal end of the puncture member 8 can extend out of the front end segment 31. During delivery, the puncture member and the flexible electrode band move forward as a whole. The tip of the puncture member first contacts the tissue and establishes a puncture channel. The flexible electrode band then enters the target position. The puncture member provides axial stiffness for the flexible electrode, enabling it to pass smoothly through the tissue without bending.

[0042] In some embodiments, the puncture member 8 may be a tungsten needle. As used herein, when referring to a "tungsten needle," it may mean an elongated needle-like member made of tungsten material. Tungsten needles have high hardness and elastic modulus, sufficient axial stiffness even at micro-diameters (e.g., on the order of tens of micrometers), and good biocompatibility, allowing for smooth withdrawal after puncture guidance. It is understood that stainless steel needles or other medical metal puncture needles with sufficient stiffness may also be used as alternatives. The aperture of the perforation 11 matches the diameter of the puncture member, ensuring reliable anchoring and allowing the puncture member to withdraw smoothly after reaching the target point, while the flexible electrode remains in place due to friction with the tissue and its own flexibility.

[0043] Electrode contacts In some embodiments, the surface of the front end segment 31 may be provided with multiple electrode contacts 12. These contacts can be used to form electrical contact with the target nerve tissue after implantation to achieve the acquisition of nerve signals or the application of electrical stimulation. The number, arrangement, and size of the electrode contacts 12 can be designed according to specific application requirements (e.g., the number of recording channels, target size).

[0044] In some embodiments, the electrode contact 12 may be made of gold or platinum-iridium. Both gold and platinum-iridium have excellent conductivity and corrosion resistance, and can maintain stable electrical performance over a long period of time in bodily fluid environments.

[0045] Leading out an opening In some implementations, such as Figure 1 , Figure 2 and Figure 5 As shown, the proximal region of the cannula 1 may have an exit opening 7. As used herein, when referring to an "exit opening," it may refer to a through-hole structure formed in the cannula wall for the extension segment to pass through. The flexible electrode band 3 may have an extension segment 32 extending proximally from the electrode band assembly, and the extension segment 32 can pass through the exit opening 7 to the outside of the cannula 1. During the operation, the extension segment can be directly connected to the acquisition device after being led out from the proximal end of the cannula, without the need for a lead wire to run from the front end, avoiding traction interference from the implanted site, and facilitating real-time monitoring of signal quality during the operation.

[0046] In some implementations, such as Figure 5 As shown, the lead-out opening 7 can be opened on the top wall of the proximal region of the sleeve 1, and the extension section 32 can be led out upward from the top wall. This lead-out direction ensures that the routing of the extension section will not interfere with the operator's grip on the sleeve and button operation.

[0047] In some implementations, such as Figure 5 As shown, a removable sealing plug 13 can be provided at the outlet opening 7. The sealing plug 13 can be configured to block the outlet opening 7 when not connected to an external device. When no external device is required, the sealing plug 13 can prevent tissue fluid or contaminants from entering the cannula, keeping the inner cavity of the cannula clean.

[0048] In some embodiments, the extension 32 of the flexible electrode strip 3 can be connected to an external device after passing through the lead-out opening 7. The external device can be any one of a nerve signal acquisition chip, an electrical stimulator, or an adapter interface board. The operator can select the appropriate external device according to the specific surgical needs, for example, connecting the acquisition chip in recording mode and the electrical stimulator in treatment mode.

[0049] Multi-channel variant In some implementations, the flexible electrode strip 3 can be a multi-channel parallel structure, and the number of puncture components 8 can be multiple, each corresponding to a puncture hole 11 in the multi-channel parallel structure. For applications requiring multi-point recording or stimulation (e.g., electrocorticometry arrays), the multi-channel parallel structure can complete the simultaneous implantation of multiple electrode channels in a single delivery operation.

[0050] Material selection In some embodiments, the sleeve 1 can be made of polyetheretherketone, polycarbonate, or titanium alloy. These materials all have good biocompatibility and mechanical strength, and can be selected according to the sterilization method (high-temperature steam sterilization, ethylene oxide sterilization, etc.) and cost requirements.

[0051] delivery method Figure 6This is a schematic flowchart of a flexible electrode delivery method 600, which is an exemplary embodiment of this disclosure. Figure 6 As shown, method 600 may include steps S610 to S620.

[0052] In step S610, the electrode band assembly can be moved from a retracted position to an extended position by a drive component (e.g., in response to an operator's action). The flexible electrode band, carrying the puncture member (e.g., axially), extends out of the cannula and punctures the target tissue. As an example, and not a limitation, the puncture member may first contact the target tissue and establish a puncture channel, after which the flexible electrode band 3 enters the target tissue. In practice, the operator can press a button to move the push rod forward, opening the two halves of the electrode protection device, which are then pushed open by the electrode band assembly. The flexible electrode band extends from the distal end of the cannula together with the puncture member, and the tip of the puncture member first pierces the tissue and establishes a puncture channel.

[0053] In step S620, the puncture member can be withdrawn from the flexible electrode band, with the tip of the flexible electrode band (e.g., due to friction with the target tissue and its own flexibility) remaining in place and adhering to the target tissue. The puncture member can be withdrawn after reaching the target point, and due to the flexibility of the flexible electrode, the friction between it and the tissue is sufficient to keep it in place after the puncture member is withdrawn.

[0054] In some embodiments, method 600 may further include connecting the extension segment to an external device. The extension segment may be led out through an exit opening in the proximal region of the cannula and connected to a neural signal acquisition chip or an electrical stimulator for signal recording or stimulation.

[0055] In some embodiments, method 600 may further include: after the electrode band assembly is in the extended position, driving the electrode band assembly from the extended position to the retracted position via a driving component to adjust the implantation depth or protect the tip of the indwelling flexible electrode band. In clinical practice, if the initial implantation position is not ideal, the operator can retract and re-extend the electrode band assembly to achieve repeated fine-tuning of the implantation depth until a satisfactory delivery effect is achieved.

[0056] The foregoing description enables others to make or use the disclosed subject matter. Modifications to the embodiments are readily apparent, and the basic principles can be applied to other embodiments without departing from the spirit or scope of the foregoing description. Therefore, the foregoing description should not be strictly limited to the embodiments shown, but should be interpreted in the broadest scope consistent with the disclosed principles and novel features. In this document, unless explicitly stated otherwise, references to elements in the singular form do not imply exclusivity, but rather include “one or more.” Similarly, unless explicitly stated otherwise, the term “some” refers to one or more instances. All structural and functional equivalents of the elements described in the foregoing description are expressly incorporated by reference and are intended to be covered by the claims. Furthermore, the disclosure herein should not be construed as making the disclosed subject matter exclusive to the public, regardless of whether such disclosure is expressly mentioned in the claims. Claims should not be construed as means plus function unless the element is expressly declared using the phrase “means for…”. It should be understood that the order of steps in the disclosed method is purely for illustrative purposes. The order of steps in the method may be rearranged according to design preferences while remaining within the scope of the foregoing description.

[0057] While this disclosure has been described in conjunction with what are considered to be the most practical and preferred embodiments, it should be understood that this disclosure is not limited to the disclosed embodiments, but is intended to cover various arrangements made without departing from the broadest interpretation of the appended claims. The above description is merely a preferred embodiment of the invention and is not intended to limit the invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the invention should be included within the scope of protection of the invention.

Claims

1. A flexible electrode telescopic delivery device, characterized in that, include: The sleeve (1) is a tubular shell extending along the axial direction, having a distal end and a proximal end, the distal end constituting the insertion end of the sleeve (1), and the proximal end constituting the operating end of the sleeve (1). An electrode band assembly is movably disposed within the sheath (1) along the axial direction. The electrode band assembly is movable between a retracted position housed within the sheath (1) and an extended position extending from the distal end of the sheath (1). The electrode band assembly includes a flexible electrode band (3) and a puncture member (8) passing through the front end of the flexible electrode band (3). The puncture member (8) is used to provide axial stiffness to the flexible electrode band (3) and establish a puncture channel during delivery. A drive assembly, disposed within the cannula (1) and connected to the electrode band assembly, is configured to, in response to an operator's operation, drive the electrode band assembly to move relative to the cannula (1) between the extended position and the retracted position, so that the flexible electrode band (3) can extend from the cannula (1) with the puncture member (8) and puncture to the target position, and retract after delivery.

2. The flexible electrode telescopic delivery device according to claim 1, characterized in that, It also includes an electrode protection device (2) disposed at the distal end of the sleeve (1). When the electrode strip assembly is in the retracted position, the electrode protection device (2) closes the distal opening of the sleeve (1); when the electrode strip assembly is in the extended position, the electrode protection device (2) opens the distal opening.

3. The flexible electrode telescopic delivery device according to claim 2, characterized in that, The electrode protection device (2) is a two-lobed elastic cover. When the electrode band assembly is in the retracted position, the two lobes are closed; when the electrode band assembly moves from the retracted position to the extended position, the electrode band assembly pushes open the two lobes.

4. The flexible electrode telescopic delivery device according to claim 1, characterized in that, The driving component includes: A push rod (4) is disposed in the sleeve (1) along the axial direction, and the distal end of the push rod (4) is connected to the electrode strip assembly; Button (6) is connected to the proximal end of the push rod (4) and is at least partially exposed outside the proximal end of the sleeve (1); An elastic reset member (5) is disposed inside the sleeve (1) and acts on the push rod (4). The elastic reset member (5) is configured to apply a reset force to the push rod (4) to move from the extended position to the retracted position.

5. The flexible electrode telescopic delivery device according to claim 4, characterized in that, The elastic reset member (5) is sleeved on the front end of the push rod (4), and one end of the elastic reset member (5) abuts against the fixing shoulder (14) provided on the inner wall of the sleeve (1).

6. The flexible electrode telescopic delivery device according to claim 1, characterized in that, The flexible electrode strip (3) includes a front end section (31) and an extension section (32), wherein the front end section (31) and the extension section (32) are integrally connected.

7. The flexible electrode telescopic delivery device according to claim 6, characterized in that, The front end segment (31) and the extension segment (32) are integrally formed from the same flexible insulating substrate.

8. The flexible electrode telescopic delivery device according to claim 7, characterized in that, The flexible insulating substrate is a polyimide film.

9. The flexible electrode telescopic delivery device according to claim 6, characterized in that, The distal end of the front end segment (31) is provided with a perforation (11) through which the puncture member passes, the puncture member (8) passes through the perforation (11) and the distal end of the puncture member (8) extends out of the front end segment (31).

10. The flexible electrode telescopic delivery device according to claim 1, characterized in that, The puncture component (8) is a tungsten needle.

11. The flexible electrode telescopic delivery device according to claim 6, characterized in that, The surface of the front end segment (31) is provided with multiple electrode contacts (12).

12. The flexible electrode telescopic delivery device according to claim 11, characterized in that, The electrode contacts (12) are made of gold or platinum-iridium.

13. The flexible electrode telescopic delivery device according to claim 1, characterized in that, The proximal region of the sleeve (1) is provided with an outlet opening (7), and the flexible electrode strip (3) has an extension section (32) extending from the electrode strip assembly toward the proximal end, the extension section (32) passing through the outlet opening (7) to the outside of the sleeve (1).

14. The flexible electrode telescopic delivery device according to claim 13, characterized in that, The lead-out opening (7) is located on the top wall of the proximal region of the sleeve (1), and the extension section (32) extends upward from the top wall.

15. The flexible electrode telescopic delivery device according to claim 13, characterized in that, A pluggable sealing plug (13) is provided at the outlet opening (7), and the sealing plug (13) is configured to block the outlet opening (7) in a non-external state.

16. The flexible electrode telescopic delivery device according to claim 13, characterized in that, The extension section (32) passes through the lead-out opening (7) and is connected to an external device, which is any one of a neural signal acquisition chip, an electrical stimulator, or an adapter interface board.

17. The flexible electrode telescopic delivery device according to claim 1, characterized in that, The flexible electrode strip (3) has a multi-channel parallel structure, and the number of puncture components (8) is multiple and they are set one-to-one with the perforations (11) of the multi-channel parallel structure.

18. The flexible electrode telescopic delivery device according to claim 1, characterized in that, The sleeve (1) is made of polyetheretherketone, polycarbonate or titanium alloy.

19. A method for delivering a flexible electrode, characterized in that, The flexible electrode telescopic delivery device as described in any one of claims 1 to 18 includes the following steps: The drive assembly responds to the operator's operation by moving the electrode band assembly from the retracted position to the extended position. The flexible electrode band (3) carries the puncture member (8) and extends it out of the cannula (1) along the axial direction. The puncture member (8) first contacts the target tissue and establishes a puncture channel. The flexible electrode band (3) then enters the target tissue. The puncture member (8) is removed from the flexible electrode band (3), and the front end of the flexible electrode band (3) remains and adheres to the target tissue due to friction with the target tissue and its own flexibility.

20. The flexible electrode delivery method according to claim 19, characterized in that, After the puncture component (8) is withdrawn, the extension section (32) of the flexible electrode strip (3) is connected to the external device through the lead-out opening (7) in the proximal region of the cannula (1). The extension section (32) extends from the electrode strip assembly to the proximal end of the cannula (1).

21. The flexible electrode delivery method according to claim 20, characterized in that, The external device is any one of a neural signal acquisition chip, an electrical stimulator, or an adapter board.

22. The flexible electrode delivery method according to claim 19, characterized in that, After the electrode strip assembly is in the extended position, the drive assembly drives the electrode strip assembly to move from the extended position to the retracted position in order to adjust the implantation depth or protect the front end of the indwelling flexible electrode strip (3).

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