Implantable device and method of manufacturing the same

Abstract

An implantable device and a manufacturing method thereof, wherein the implantable device comprises: a first electrode, the first electrode comprising: a catheter, the catheter having opposite first and second ends in an axial direction, the catheter having at least one built-in channel, wherein the built-in channel extends from the second end towards the first end and extends towards a tube wall of the catheter, and the tube wall is provided with an opening in communication with the built-in channel; a plurality of electrode rings, the plurality of electrode rings being arranged on an outer surface of the catheter in the axial direction of the catheter and being closer to the first end than to the second end; and at least one second electrode, the at least one second electrode being accommodated in the at least one built-in channel, the second electrode comprising at least one electrode site, and the second electrode being capable of extending out of the opening of the corresponding built-in channel. The microelectrode can reliably and smoothly extend out of the side of the macroelectrode, the position and angle of the implantable device in the target brain area can be enriched, and the neuron range and monitoring effect of the brain electrical monitoring can be improved.

Description

Technical Field

[0001] This invention relates to the field of neural electrode technology, and more specifically to an implantable device and its manufacturing method. Background Technology

[0002] Deep intracranial electrodes are the most valuable auxiliary diagnostic and therapeutic tool in the preoperative surgical evaluation of refractory epilepsy. Using deep intracranial electrodes, action field potentials in the brain tissue discharge initiation zone of epilepsy patients can be recorded, helping to identify areas of functional abnormality and irritability, and can be used to determine the intensity and extent of suspected epileptogenic cortical abnormal discharges. Because deep intracranial electrodes are in direct contact with the cerebral cortex, the electrical signals they acquire can directly reflect the actual electrophysiological activity of the implanted brain region. Therefore, stereotactic electroencephalography (SEEG) recording methods can achieve excellent monitoring of cortical neurophysiological activity in three-dimensional space with high regional accuracy. These characteristics make it irreplaceable in both clinical lesion localization and basic neuroscience research.

[0003] In clinical practice, medical professionals use deep intracranial electrodes with multiple macroelectrodes to focus on and differentiate epileptiform abnormal discharges occurring during and between seizures, including spike waves, sharp waves, spike-and-slow wave complexes, and sharp-and-slow wave complexes. By analyzing the generation and propagation patterns of these epileptiform abnormal discharges within the brain, medical professionals can identify epileptic structures in the brain of epilepsy patients, thereby determining the location and extent of the epileptogenic focus, supporting further ablation surgery.

[0004] In clinical practice, it is often necessary to record 3 to 5 spontaneous seizures consistent with the usual pattern of seizures to provide sufficient data for medical professionals to confirm the location and extent of the epileptogenic focus. This necessitates prolonged intracranial EEG monitoring after implantation of deep intracranial electrodes to capture a sufficient number of seizure events. This prolonged monitoring not only increases the consumption of medical resources but also raises the risk of infection and other complications. In some cases, epilepsy patients do not experience any seizures during the entire EEG monitoring process, leading to diagnostic failure. The root cause of this situation is that existing deep intracranial electrodes can only acquire local field potential signals at specific locations within the brain, forcing medical professionals to rely on the limited information provided by these local field potentials for diagnosis and analysis.

[0005] On the other hand, various patterns of rhythmic oscillations exist within the brain. These periodic oscillations, with different frequency ranges, provide temporal synchronization for the encoding, storage, and retrieval of neural information by groups of neurons in the brain, and also reflect different activity patterns in the information processing of the brain's neural networks. Compared to macroelectrodes, microelectrodes can record potential changes at a smaller scale, such as individual nerve cells, and can also record signals with higher frequencies, thus achieving higher resolution.

[0006] Because microelectrodes can effectively supplement electrical signals that macroelectrodes cannot capture, thus better locating epileptic lesions, macro-microelectrodes, which combine microelectrodes and macroelectrodes, have become one of the important future development directions for implantable devices. Current macro-microelectrodes generally employ a method where the microelectrode is placed within the macroelectrode, and the microelectrode can extend from within the macroelectrode to the outside of it for implantation.

[0007] However, the extension positions of microelectrodes in existing macroelectrodes are relatively limited. For example, the opening is usually at the end of the macroelectrode, and the microelectrode can only extend from the front end of the macroelectrode to be implanted into the target brain region. This combination greatly restricts the implantation angle and position of the microelectrode, resulting in insufficient range of neurons that the microelectrode can record within the target brain region, and in severe cases, it can even lead to the failure of EEG monitoring.

[0008] Therefore, improving the flexibility of microelectrode implantation, enabling implantable devices to reach a wider range of implantation sites, is one of the urgent technical problems to be solved today. Summary of the Invention

[0009] The technical problem solved by this invention is how to improve the flexibility of microelectrode implantation in the brain, so that implantable devices can reach a wider range of implantation sites.

[0010] To address the aforementioned technical problems, embodiments of the present invention provide an implantable device, comprising: a first electrode, the first electrode comprising: a catheter having a first end and a second end opposite to each other along an axial direction, the catheter having at least one internal channel, wherein the internal channel extends from the second end toward the first end and toward the wall of the catheter, the wall having an opening communicating with the internal channel; a plurality of electrode rings, the plurality of electrode rings being spaced apart along the axial direction of the catheter on the outer surface of the catheter, the plurality of electrode rings being closer to the first end than the second end; and at least one second electrode, the at least one second electrode being accommodated within the at least one internal channel, the second electrode including at least one electrode site, the second electrode being able to extend from the opening of the corresponding internal channel.

[0011] Optionally, the opening is formed on the tube wall between adjacent electrode rings, or the opening is formed on the electrode ring.

[0012] Optionally, the conduit has multiple built-in channels, and the conduit wall is correspondingly provided with multiple openings communicating with the built-in channels. At least a portion of the multiple openings are opened on the conduit wall between two adjacent electrode rings and are located at different positions along the circumference of the conduit wall; or, at least a portion of the multiple openings are opened at different positions along the circumference of the same electrode ring.

[0013] Optionally, the conduit has multiple built-in channels, and the conduit wall is correspondingly provided with multiple openings communicating with the built-in channels. At least a portion of the multiple openings are opened at different positions on the conduit wall along the circumference of the conduit, and / or, at least a portion of the multiple openings are opened at different positions on the conduit wall along the axial direction of the conduit.

[0014] Optionally, the built-in channel includes an extension section extending axially along the conduit, and a curved section extending obliquely from the extension section toward the conduit wall, the curved section being closer to the first end than the extension section.

[0015] Optionally, the catheter has multiple built-in channels, at least a portion of which share the same extension segment, or the multiple built-in channels are independent of each other.

[0016] Optionally, the angle between the extension direction of the curved section and the axial direction of the conduit is less than 30 degrees, 45 degrees, or 60 degrees.

[0017] Optionally, the curved segment is arc-shaped.

[0018] Optionally, the diameter of the conduit is less than 1.8 mm, and / or the electrode ring is made of platinum, iridium, platinum alloy, iridium alloy, or platinum-iridium alloy.

[0019] Optionally, the at least one second electrode and the at least one built-in channel correspond one-to-one, or at least two second electrodes are housed within the same built-in channel.

[0020] Optionally, the first electrode further includes: a plurality of first wires, which are insulated from each other and embedded in the wall of the conduit, and the plurality of first wires are coupled to the plurality of electrode rings in a one-to-one correspondence.

[0021] Optionally, the catheter further has a cavity extending along the axial direction of the catheter, and the first electrode further includes a plurality of first wires, which are insulated from each other and housed within the cavity and coupled to the plurality of electrode rings in a one-to-one correspondence.

[0022] Optionally, the cavity and the at least one built-in channel are independent of each other, or the at least one built-in channel is housed within the cavity.

[0023] Optionally, the implantable device further includes: at least one guiding mechanism, wherein the at least one guiding mechanism and the at least one second electrode are respectively housed within the at least one built-in channel.

[0024] Optionally, the guiding mechanism includes: a guide pin, which is physically connected to the corresponding second electrode; and a guide wire, which extends from the guide pin along the corresponding built-in channel toward the second end.

[0025] Optionally, the implantable device further includes: a bifurcated compartment disposed at the second end, the bifurcated compartment including an input branch, a first output branch and a second output branch, the input branch, the first output branch and the second output branch converging within the compartment cavity of the bifurcated compartment, the second end extending from the input branch into the compartment cavity, multiple first wires extending from the second end extending into the first output branch, and at least one second electrode extending from the second end extending into the second output branch, the multiple first wires and the multiple electrode rings being coupled one-to-one.

[0026] Optionally, the implantable device further includes a signal transmission module, at least a portion of which extends into the second output branch and is coupled to the at least one second electrode.

[0027] Optionally, the plurality of first wires extend beyond the branch compartment from the first output branch.

[0028] Optionally, the bifurcation chamber further includes a third output branch, which intersects with the input branch within the chamber cavity. The implantable device also includes a push wire that extends from the third output branch through the chamber cavity into at least one built-in channel at the second end. The push wire is physically connected to the at least one second electrode and is used to guide the at least one second electrode to move along the at least one built-in channel.

[0029] Optionally, the implantable device further includes a sealing and fixing mechanism, which is disposed on the third output branch and sleeved on the push wire. The sealing and fixing mechanism is used to support and hold the push wire and seal the third output branch after the push wire is removed.

[0030] Optionally, the implantable device further includes: a push handle, which is fixed to the push wire; optionally, a scale is printed on the push wire to indicate the movement distance of the push wire.

[0031] Optionally, the second electrode can move between a retracted position and an extended position. When in the retracted position, the second electrode is housed within the corresponding built-in channel. When in the extended position, at least a portion of the second electrode extends out of the tube wall from the opening.

[0032] Optionally, the first electrode includes an intracranial brain electrode, and the second electrode includes a flexible electrode.

[0033] To address the aforementioned technical problems, this invention provides a method for manufacturing the implantable device, comprising: providing at least one inner liner tube, the inner liner tube being a hollow structure; placing the at least one inner liner tube into a catheter mold, wherein the inner liner tube is bent to a preset angle before or during placement, the catheter mold being used for injection molding to form a catheter; providing a plurality of electrode rings and placing them into the catheter mold; and injection molding a first electrode based on the catheter mold, wherein the at least one inner liner tube is located within the catheter and is adapted to form at least one internal channel, the internal channel being adapted to accommodate a second electrode, the plurality of electrode rings being sleeved on the catheter, and an opening communicating with the internal channel being provided on the wall of the catheter.

[0034] Optionally, before placing the at least one inner liner tube into the conduit mold, the manufacturing method further includes bending the inner liner tube to the preset angle.

[0035] Optionally, bending the inner liner tube to the preset angle includes bending the inner liner tube to the preset angle through heat treatment or stress deformation.

[0036] Optionally, the material of the inner liner is selected from at least one of the following: polymer materials and metal materials.

[0037] Optionally, the catheter is made of silicone material.

[0038] Optionally, placing the at least one inner liner tube into the conduit mold includes: injection molding a first portion of the conduit based on the conduit mold, the first portion having at least one receiving groove, wherein the extension direction of at least a portion of the receiving groove and the axial direction of the conduit have an angle with the preset angle; and placing the at least one inner liner tube into the at least one receiving groove respectively.

[0039] Optionally, before placing the at least one inner liner tube into the at least one receiving slot, the extension direction of the inner liner tube is parallel to the axial direction of the conduit.

[0040] Optionally, the opening is formed simultaneously during the step of injection molding the first electrode based on the conduit mold.

[0041] Optionally, the conduit mold has a pre-embedded hole corresponding to the opening.

[0042] Optionally, after the first electrode is formed by injection molding based on the conduit mold, the manufacturing method further includes: opening at least one opening in the wall of the conduit, wherein the at least one opening corresponds one-to-one with the at least one built-in channel.

[0043] Optionally, the opening is formed on the tube wall between adjacent electrode rings, or the opening is formed on the electrode ring.

[0044] Optionally, the manufacturing method further includes: inserting at least one second electrode into the at least one built-in channel to obtain the implantable device.

[0045] Optionally, inserting at least one second electrode into the at least one built-in channel includes: providing a bifurcation chamber, the bifurcation chamber including an input branch, a first output branch, and a second output branch, the input branch, the first output branch, and the second output branch converging within the chamber cavity of the bifurcation chamber; incorporating the first electrode into the input branch and extending the first electrode from the first output branch via the chamber cavity; providing a push wire, the tip of the push wire being physically connected to the corresponding second electrode; extending the tip of the push wire and the physically connected second electrode together via the chamber cavity into the at least one built-in channel, the at least one second electrode corresponding to the at least one built-in channel; and incorporating the rear portion of the at least one second electrode not connected to the push wire via the chamber cavity into the second output branch.

[0046] Optionally, the bifurcation chamber further includes a third output branch, which intersects with the input branch within the chamber cavity. The manufacturing method further includes: incorporating the push wire into the third output branch via the chamber cavity, wherein the axial direction of the third output branch coincides with or is parallel to the axial direction of the input branch; and pushing the push wire to move the at least one second electrode within the at least one built-in channel.

[0047] Compared with the prior art, the technical solution of the embodiments of the present invention has the following beneficial effects: This invention provides an implantable device comprising: a first electrode, the first electrode comprising: a catheter having a first end and a second end opposite each other along an axial direction, the catheter having at least one internal channel, wherein the internal channel extends from the second end toward the first end and toward the wall of the catheter, the wall having an opening communicating with the internal channel; a plurality of electrode rings spaced apart along the axial direction of the catheter on the outer surface of the catheter, the plurality of electrode rings being closer to the first end than the second end; and at least one second electrode, the at least one second electrode being accommodated within the at least one internal channel, the second electrode including at least one electrode site, the second electrode being able to extend from the opening of the corresponding internal channel.

[0048] Existing macroelectrodes and microelectrodes have relatively limited extension positions, restricting their flexibility in implantation within target brain regions. Furthermore, the uncontrollable extension direction of the microelectrode after extending from the macroelectrode results in insufficient capture range of neuronal electrical signals, impacting EEG monitoring effectiveness. In contrast, this implementation expands the extension positions of the microelectrode by providing a lateral opening on the first electrode (i.e., the macroelectrode) for the second electrode (i.e., the microelectrode), improving the flexibility of implantation and allowing the device to reach more areas of the target brain region. Furthermore, the inclusion of a bent, extended internal channel allows the second electrode to move along this channel, with a controllable extension direction beyond the first electrode. This facilitates precise implantation of the microelectrode at the desired location within the target brain region, expanding the detection range of neurons and obtaining a wider and / or more accurate range of neural signals. Thus, the microelectrode reliably and smoothly extends from the side of the macroelectrode, enriching the positions and angles the implantable device can reach in the target brain region, improving the neuronal range and monitoring effectiveness of EEG monitoring.

[0049] Furthermore, by adding multiple built-in channels and corresponding openings to the conduit, the number of microelectrodes integrated into the first electrode is increased. Moreover, microelectrodes extending from different openings can be implanted at different depths and orientations, further expanding the range of neuronal electrical signal capture by the microelectrodes and effectively supplementing neuronal electrical signals that cannot be captured by the macroelectrode.

[0050] Furthermore, by adjusting the bending angle of the built-in channel bending section, the angle and direction of the microelectrode extension can be flexibly adjusted and controlled to meet the actual situation or clinical needs of different patients.

[0051] Furthermore, the multiple built-in channels are set independently to ensure that the movement of multiple microelectrodes within their respective built-in channels will not interfere with each other, which helps to improve the stability of microelectrode implantation.

[0052] Furthermore, by setting a push wire, a driving force is generated on the microelectrode to assist the microelectrode in moving within the built-in channel, thereby facilitating the implantation of the microelectrode.

[0053] Furthermore, a sealing and fixing mechanism is fitted onto the push wire to stabilize it during the pushing operation. Additionally, after the push wire is withdrawn, the sealing and fixing mechanism can be locked to seal the third output branch corresponding to the push wire, preventing leakage of tissue fluid from the target brain region.

[0054] Furthermore, the push wire is marked with graduations to precisely control the push depth, ensuring that the microelectrode reaches a sufficient implantation depth without being implanted too deeply and damaging the brain.

[0055] Furthermore, by controlling the movement of the microelectrode between its retracted and extended positions, the microelectrode is ensured to remain in the retracted position during macroelectrode implantation, preventing premature extension of the microelectrode into the internal channel and potential damage to the brain. Additionally, after macroelectrode implantation, the microelectrode is controlled to move to the extended position, achieving effective implantation.

[0056] This invention also provides a method for manufacturing an implantable device, the method comprising: providing at least one inner liner tube, the inner liner tube being a hollow structure; placing the at least one inner liner tube into a catheter mold, wherein the inner liner tube is bent to a preset angle before or during placement, the catheter mold being used for injection molding to form a catheter; providing a plurality of electrode rings and placing them into the catheter mold; and injection molding a first electrode based on the catheter mold, wherein the at least one inner liner tube is located inside the catheter and is adapted to form at least one internal channel, the internal channel being adapted to accommodate a second electrode, the plurality of electrode rings being sleeved on the catheter, and the catheter wall having an opening communicating with the internal channel.

[0057] By forming the inner liner tube into a bent structure at a predetermined angle during the manufacturing process, a built-in channel with a predetermined angle is created within the macroelectrode for the movement of the microelectrode. This allows the second electrode to move along the built-in channel and extend beyond the first electrode at a predetermined angle, making the extension angle of the second electrode controllable. This facilitates the precise implantation of the microelectrode into the desired location in the target brain region, expanding the detection range of neurons in the target brain region and obtaining a wider range and / or more accurate neural signals. Consequently, the microelectrode reliably and smoothly extends from the side of the macroelectrode, enriching the positions and angles that the implantable device can reach in the target brain region, and improving the neuronal range and monitoring effect of EEG monitoring. Attached Figure Description

[0058] Figure 1 This is a schematic diagram of an implantable device according to an embodiment of the present invention; Figure 2 yes Figure 1A sectional view of region B in the middle; Figure 3 yes Figure 2 The implantable device shown is a cross-sectional view along the AA direction. Figure 4 yes Figure 2 A cross-sectional view along the AA direction in a variation of the implantable device shown. Figure 5 yes Figure 1 The middle region B contains a cross-sectional view of the second electrode; Figure 6 yes Figure 1 A sectional view of region C in the middle; Figure 7 yes Figure 6 Schematic diagram of the central sealing and fixing mechanism; Figure 8 This is a flowchart of a method for manufacturing an implantable device according to an embodiment of the present invention; Figure 9 This is a flowchart of the process of inserting a second electrode into the built-in channel in an embodiment of the present invention. Detailed Implementation

[0059] As mentioned in the background section, the extension position of microelectrodes in macroelectrodes is relatively limited. For example, the opening is usually at the end of the macroelectrode, and the microelectrode can only extend from the front end of the macroelectrode to be implanted into the target brain region. This combination greatly restricts the implantation angle and position of the microelectrode, resulting in insufficient range of neurons that the microelectrode can record in the target brain region, and in severe cases, it may even lead to the failure of EEG monitoring.

[0060] To address the aforementioned technical problems, embodiments of the present invention provide an implantable device, comprising: a first electrode, the first electrode comprising: a catheter having a first end and a second end opposite to each other along an axial direction, the catheter having at least one internal channel, wherein the internal channel extends from the second end toward the first end and toward the wall of the catheter, the wall having an opening communicating with the internal channel; a plurality of electrode rings, the plurality of electrode rings being spaced apart along the axial direction of the catheter on the outer surface of the catheter, the plurality of electrode rings being closer to the first end than the second end; and at least one second electrode, the at least one second electrode being accommodated within the at least one internal channel, the second electrode including at least one electrode site, the second electrode being able to extend from the opening of the corresponding internal channel.

[0061] This implementation expands the extension position of the microelectrode by providing a lateral opening on the first electrode (i.e., the macroelectrode) for the second electrode (i.e., the microelectrode) to extend, improving the flexibility of implantation and allowing the implantable device to reach more areas of the target brain region. Furthermore, the inclusion of a bent, extended internal channel allows the second electrode to move along this channel and extend beyond the first electrode in a controllable direction. This facilitates precise implantation of the microelectrode at the desired location in the target brain region, expanding the detection range of neurons in the target brain region and obtaining a wider and / or more accurate range of neural signals. Thus, the microelectrode reliably and smoothly extends from the side of the macroelectrode, enriching the positions and angles that the implantable device can reach in the target brain region, and improving the range of neurons and monitoring effectiveness of EEG monitoring.

[0062] To make the above-mentioned objects, features, and beneficial effects of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. The same reference numerals are used to denote the same parts in each figure. The embodiments are merely illustrative, and of course, partial substitutions or combinations can be made to the structures shown in different embodiments. In the variations, descriptions of matters common to the first embodiment are omitted, and only the differences are described. In particular, the same effects produced by the same structure will not be mentioned one by one in each embodiment.

[0063] Figure 1 This is a schematic diagram of an implantable device 100 according to an embodiment of the present invention. Figure 2 yes Figure 1 Sectional view of region B in the middle.

[0064] Specifically, refer to Figure 1 and Figure 2 The implantable device 100 described in this embodiment may include a first electrode 11, wherein the first electrode 11 may include a catheter 110, the catheter 110 having a first end 110a and a second end 110b opposite each other along the axial direction.

[0065] Wherein, the first end 110a is the implantation end, that is, the end of the first electrode 11 implanted into a biological body (e.g., the brain), or the first end 110a can also be called the distal end, which refers to the end that is far away from the doctor or operator.

[0066] Similarly, the second end 110b is the output end, that is, the end where the first electrode 11 outputs electrical signals to the outside through connection with other external devices, or the second end 110b can also be called the proximal end, which refers to the end that is close to the doctor or operator.

[0067] After the implantable device 100 is implanted into the target brain region, the first end 110a can be located inside the organism, and the second end 110b can be exposed outside the organism.

[0068] In some embodiments, the conduit 110 may be in the shape of a long, cylindrical column. For ease of description, the axial direction of the conduit 110 is referred to as the x-direction. In some embodiments, the conduit 110 may be made of an insulating material.

[0069] Furthermore, the diameter of the catheter 110 is less than 1.8 mm.

[0070] Furthermore, the conduit 110 has at least one internal channel 111, wherein the internal channel 111 extends from the second end 110b toward the first end 110a and toward the tube wall 110c of the conduit 110, and the tube wall 110c has an opening 112 communicating with the internal channel 111.

[0071] In other words, the built-in channel 111 can connect from the inside of the conduit 110 all the way to the opening 112 on the tube wall 110c.

[0072] Furthermore, the first electrode 11 may also include a plurality of electrode rings 113, which are spaced apart on the outer surface of the conduit 110 along the axial direction (e.g., the x-direction) of the conduit 110, and the plurality of electrode rings 113 are closer to the first end 110a than the second end 110b.

[0073] The catheter 110 can serve to fix and support multiple electrode rings 113 and enable the multiple electrode rings 113 to be implanted into the target brain region.

[0074] Multiple electrode rings 113 are closer to the first end 110a. That is, multiple electrode rings 113 are located on the side closer to the implantation end. In order to ensure that multiple electrode rings 113 are located in the target brain region after implantation, so as to contact cells deeper in the body as much as possible after the implantable device 100 is implanted into the organism, so as to facilitate the first electrode 11 to collect electrical signals.

[0075] Furthermore, the electrode ring 113 is made of platinum, iridium, platinum alloy, iridium alloy, or platinum-iridium alloy.

[0076] Furthermore, the first electrode 11 may include an intracranial brain electrode, such as the neural electrode used in SEEG technology. Accordingly, the electrode ring 113 may be used for signal recording (corresponding to SEEG).

[0077] Furthermore, the first electrode 11 also includes a plurality of first wires 114, which are embedded in the wall 110c of the conduit 110 insulated from each other, and the plurality of first wires 114 are coupled to the plurality of electrode rings 113 in a one-to-one correspondence.

[0078] Specifically, except for at least one built-in channel 111, the conduit 110 is injection molded into a solid state. The first wire 114 is wrapped inside during injection molding. The first wire 114 can be used to realize the signal transmission between the electrode ring 113 and the outside world.

[0079] For example, refer to Figure 2 The first wire 114, embedded in the wall 110c of the catheter 110, can extend generally along the x-direction. One end of the first wire 114 extending along the x-direction is coupled to the corresponding electrode ring 113, and the other end extends out of the catheter 110 from the second end 110b to be coupled to an external device (e.g., a processor, computer, or therapeutic instrument). Figure 2 Three first wires 114 are shown as an example, each coupled to one of three electrode rings 113.

[0080] In some embodiments, there is a certain distance between adjacent electrode rings 113, which can be used to avoid the location of the opening 112, or in other words, the opening 112 on the tube wall 110c can be opened between adjacent electrode rings 113.

[0081] In some embodiments, the opening 112 may be formed on the electrode ring 113. It is understood that the spacing between adjacent electrode rings 113 is not limited by the position and size of the opening. However, it should be noted that the opening 112 needs to avoid the connection point between the electrode ring 113 and the first wire 114, so as to avoid disrupting the electrical signal transmission of the electrode ring 113 through the first wire 114.

[0082] In some embodiments, the spacing between two adjacent electrode rings 113 may be the same or different. In some embodiments, the lengths of the multiple electrode rings 113 extending along the x-direction may be the same or different. Figure 1 and Figure 2 The following example uses three electrode rings 113. In practical applications, the number of electrode rings 113 and the spacing between adjacent electrode rings 113 can be adjusted as needed.

[0083] Furthermore, the implantable device 100 may also include at least one second electrode 12 (such as...). Figure 5 As shown), the at least one second electrode 12 is housed within the at least one built-in channel 111, the second electrode 12 includes at least one electrode site, and the second electrode 12 is capable of extending from the opening 112 of the corresponding built-in channel 111.

[0084] In one specific implementation, there can be at least one second electrode 12, but there can be multiple second electrodes 12. In practical applications, the number of second electrodes 12 placed within the built-in channel 111 can be adjusted as needed. Generally speaking, the more second electrodes 12 there are, the more electrode sites on the second electrodes 12, enabling the implanted device 100 to achieve electrical signal interaction with more brain cells in the target brain region. For example, the number of second electrodes 12 that can be placed can be determined based on the aperture of the conduit 110 and the size of the second electrodes 12 themselves.

[0085] In some embodiments, the at least one second electrode 12 and the at least one built-in channel 111 are in one-to-one correspondence.

[0086] In some embodiments, at least two of the second electrodes 12 are housed within the same built-in channel 111.

[0087] In some embodiments, the number of the at least one built-in channel 111 can be multiple, and the number of the second electrodes 12 accommodated in each of the multiple built-in channels 111 can be the same or different.

[0088] In some embodiments, the second electrode 12 may include a flexible electrode. Specifically, the flexibility of the flexible electrode can be reflected in the fact that the second electrode 12 is a flexible structure that can be bent / folded as needed.

[0089] In some embodiments, the second electrode 12 may be generally filamentous and extend within the built-in channel 111. Furthermore, the length of the second electrode 12 may be substantially equal to / slightly less than / slightly greater than the length of the built-in channel 111.

[0090] In some embodiments, the number and location of electrode sites on each second electrode 12 may be the same or different.

[0091] Furthermore, the electrode sites on each second electrode 12 can be distributed on the portion of the second electrode 12 extending beyond the conduit 110 from the opening 112, so as to achieve reliable contact with the organism after the implantable device 100 is implanted into the organism.

[0092] Furthermore, at least one of the plurality of second electrodes 12 may extend from the opening 112 by a different distance than the other second electrodes 12, which is advantageous for the implantable device 100 to reach different depth regions after being implanted into the organism.

[0093] In a variation embodiment, the distance by which the plurality of second electrodes 12 extend from the opening 112 may also be the same, which helps to reduce the difficulty of implantation into a biological organism.

[0094] In one specific embodiment, the second electrode 12 may further include at least one second wire (not shown), with each second wire corresponding to an electrode site of at least one second electrode 12. The second wire can be used for signal transmission between the back-end system and the corresponding electrode site of the second electrode 12.

[0095] Furthermore, the conduit 110 may also have multiple built-in channels 111, and the conduit wall 110c accordingly has multiple openings 112 communicating with the built-in channels 111.

[0096] In some embodiments, the plurality of openings 112 are formed on the tube wall 110c between two adjacent electrode rings 113, and are located at different positions along the circumference of the tube wall 110c. For example, the plurality of openings 112 may be arranged circumferentially around the tube wall 110c between two adjacent electrode rings 113. The spacing between two adjacent openings 112 may be equal or unequal.

[0097] In some embodiments, the plurality of openings 112 are formed at different positions along the circumference of the same electrode ring 113 along the conduit 110. The spacing between at least two adjacent openings 112 may be different from the spacing between other adjacent openings 112.

[0098] In some embodiments, a portion of the plurality of openings 112 are opened at different positions along the circumference of the conduit 110 on the tube wall 110c between two adjacent electrode rings 113, and another portion of the openings 112 are opened at different positions along the circumference of the conduit 110 on the same electrode ring 113.

[0099] In some embodiments, the plurality of openings 112 are formed at different positions on the tube wall 110c along the axial direction of the conduit 110. For example, the number of first electrodes can be three, spaced apart along the axial direction (e.g., the x-direction) at the first end 110a, and a portion of the plurality of openings 112 can be formed between the first two adjacent first electrodes, and another portion can be formed between the last two adjacent first electrodes. Furthermore, openings can also be formed on each of the three first electrodes.

[0100] In some embodiments, the plurality of openings 112 are formed on different electrode rings 113.

[0101] In some implementations, a portion of the plurality of openings 112 are located at different positions along the axial direction of the conduit 110 on the tube wall 110c, while another portion of the openings 112 are located on different electrode rings 113.

[0102] In some embodiments, at least a portion of the plurality of openings 112 are formed at different locations along the axial direction of the conduit 110 on the pipe wall 110c.

[0103] In other words, the plurality of openings 112 can be opened at any position along the axial or circumferential direction of the tube wall 110c of the catheter 110 and / or the electrode ring 113 (except for the connection point between the electrode ring 113 and the first wire 114), as well as any combination of positions, so that the plurality of second electrodes 12 can extend from the openings 112 at different positions, thereby allowing the second electrodes 12 to be implanted into the organism at different depths and in different orientations.

[0104] It should be noted that when the opening 112 is made on the electrode ring 113, it is necessary to avoid the connection point between the electrode ring 113 and the first wire 114 to avoid damaging the electrical connection between the first electrode 11 and the organism.

[0105] By adding multiple built-in channels 111 and corresponding openings 112 to the conduit 110, the number of second electrodes 12 (i.e., microelectrodes) integrated into the first electrode 11 is increased. Furthermore, the second electrodes 12 extending from different openings can be implanted at different depths and orientations, further expanding the range of neuronal electrical signal capture by the second electrodes 12 and effectively supplementing the neuronal electrical signals that the first electrode 11 (i.e., macroelectrode) cannot capture.

[0106] Furthermore, the built-in channel 111 includes an extension 111b extending along the axial direction (e.g., the x-direction) of the conduit 110, and a curved section 111a extending obliquely from the extension 111b toward the conduit wall 110c, the curved section 111a being closer to the first end 110a than the extension 111b.

[0107] Furthermore, the curved segment 111a is arc-shaped.

[0108] In some embodiments, when the catheter 110 has multiple built-in channels 111, the multiple built-in channels 111 can be independent of each other and do not affect each other.

[0109] Multiple built-in channels 111 are set independently to ensure that the movement of multiple second electrodes 12 (i.e., microelectrodes) within their respective built-in channels 111 will not interfere with each other, which is beneficial to improving the stability of the second electrode 12 during implantation.

[0110] Furthermore, the lengths of the various extension segments 111b of the multiple built-in channels 111 can be the same or different.

[0111] Similarly, the lengths of the various curved segments 111a of the multiple built-in channels 111 can be the same or different.

[0112] Furthermore, the angle between the extension direction of the curved section 111a and the axial direction of the conduit 110 can be less than 30 degrees, 45 degrees or 60 degrees.

[0113] In practical applications, when the catheter 110 has multiple internal channels 111, the angle between the extending direction of the curved section 111a of each internal channel 111 and the axial direction of the catheter 110 can be the same or different. For example, when the catheter 110 has three internal channels 111, the angles between the extending direction of the curved section 111a of the three internal channels 111 and the axial direction of the catheter 110 can be 25 degrees, 40 degrees, and 50 degrees, respectively.

[0114] By adjusting the bending angle of the curved section 111a of the built-in channel 111, the angle and direction of the second electrode 12 can be flexibly adjusted and controlled to meet the actual situation or clinical needs of different patients.

[0115] Furthermore, combined with Figure 3 and Figure 4 The conduit 110 may also have a cavity 115 extending along the axial direction (e.g., the x direction) of the conduit 110, wherein the first electrode 11 includes a plurality of first wires 114 which are insulated from each other and housed within the cavity 115 and coupled one-to-one with the plurality of electrode rings 113.

[0116] Furthermore, one end of the first wire 114 extends into the cavity 115 along the extension direction and is coupled to the corresponding electrode ring 113, while the other end extends out of the cavity 115 from the opening at the second end 110b.

[0117] In some embodiments, for example Figure 3 As shown, the cavity 115 and the at least one built-in channel 111 are independent of each other.

[0118] In some embodiments, for example Figure 4 As shown, the at least one built-in channel 111 is housed within the cavity 115.

[0119] In one specific embodiment, the implantable device 100 may further include a fixing part (not shown) disposed within the cavity 115, which can be used to fix at least one built-in channel 111. This prevents the built-in channel 111 from unexpectedly shifting within the cavity 115.

[0120] further, Figure 5 yes Figure 1 Region B contains a cross-sectional view of the second electrode 12, see reference. Figure 5The implantable device 100 may further include at least one guiding mechanism (not shown), wherein the at least one guiding mechanism and the at least one second electrode 12 are respectively housed within the at least one built-in channel 111.

[0121] Furthermore, the guiding mechanism may include a guide pin 122, which is physically connected to the corresponding second electrode 12.

[0122] Specifically, the physical connection may be, for example, bonding the guide needle 122 to the second electrode 12, thereby driving the second electrode 12 to move through the guide needle 122 to implant the second electrode 12 into the target brain region.

[0123] Alternatively, the second electrode 12 may have a wire hole at its front end. A guide needle 122 may be passed through the wire hole of the second electrode 12 beforehand, thereby driving the second electrode 12 to move through the wire hole and implanting the second electrode 12 into the target brain region.

[0124] In one specific implementation, for example, the needle body of the guide needle 122 can be designed as a cone shape. The diameter of the upper half of the conical guide needle 122 is smaller than the diameter of the wire hole of the second electrode 12, so that it is easy to insert into the wire hole. The diameter of the lower half of the conical guide needle 122 is larger than the diameter of the wire hole of the second electrode 12, ensuring that the guide needle 122 can drive the second electrode 12 to move synchronously through the wire hole, so as to be further implanted into the biological body.

[0125] The guiding mechanism may further include a guide wire 123, which extends from the guide needle 122 along the corresponding built-in channel 111 toward the second end 110b.

[0126] The guide wire 123 is used to pull the guide needle 122 out of the biological body along the built-in channel 111 after the guide needle 122 drives the second electrode 12 to complete the implantation.

[0127] In some embodiments, when the catheter 110 has multiple built-in channels 111, at least a portion of the multiple built-in channels 111 may share the same extension segment 111b.

[0128] Specifically, in the scenario where multiple built-in channels 111 share the same extension section 111b, the guiding mechanism can be a curved section 111a that is pre-inserted into the corresponding built-in channel 111. For example, the guide pin 122 and a portion of the guide wire 123 are pre-inserted into and remain in the curved section 111a.

[0129] In some embodiments, the guide needle 122 may also be made of a biodegradable material. In a typical application scenario, after the guide needle 122 implants the second electrode 12 into a living organism, the guide needle 122 gradually degrades upon contact with cerebrospinal fluid.

[0130] In some embodiments, the biodegradable material may be, for example, a magnesium alloy. Physiological salt ions in cerebrospinal fluid and other bodily fluids can corrode and accelerate the degradation of magnesium alloys.

[0131] In some embodiments, the biodegradable material may be, for example, a biodegradable polyurethane material.

[0132] In some embodiments, the size of the guide needle 122 can be determined based on the degradation rate of the biodegradable material used in the guide needle 122, so as to avoid the second electrode 12 degrading before reaching the target brain region, which would cause the guide needle 122 to separate from the second electrode 12 prematurely.

[0133] Furthermore, the second electrode 12 is movable between a retracted position and an extended position. When the second electrode 12 is in the retracted position, it is housed within the corresponding internal channel 111. When the second electrode 12 is in the extended position, at least a portion of it extends beyond the tube wall 110c from the opening 112.

[0134] Combination Figure 5 , Figure 5 In the embodiment shown, both the second electrode 12 and the guide pin 122 are in the retracted position, which is located within the bent section 111a. However, this is not the only case. In practical applications, the second electrode 12 in the retracted position can also be located within the extended section 111b.

[0135] For example, before and during implantation of the implantable device 100 into a biological body, the second electrode 12 can remain in the retracted position, that is, the second electrode 12 is completely housed within the built-in channel 111. After the catheter 110 reaches the target area of ​​the biological tissue, a guide wire 123 can be used to guide the guide needle 122 to extend the second electrode 12 out of the opening 112 to the extended position, and the second electrode 12 can be further implanted into the target brain region.

[0136] By controlling the movement of the second electrode 12 (i.e., the microelectrode) between its retracted and extended positions, the second electrode 12 is kept in the retracted position during the implantation of the first electrode 11 (i.e., the macroelectrode), preventing the second electrode 12 from prematurely extending out of the built-in channel 111 and being damaged or harmed to the brain. Furthermore, after the first electrode 11 is implanted, the second electrode 12 is controlled to move to the extended position, achieving effective implantation of the second electrode 12.

[0137] Figure 6This is a cross-sectional view of region C of an implantable device 100 according to an embodiment of the present invention. Figure 7 yes Figure 6 A schematic diagram of the sealing and fixing mechanism 15 of the implantable device 100.

[0138] refer to Figure 6 and Figure 7 The implantable device 100 further includes a branch compartment 13 disposed at the second end 110b, the branch compartment 13 including an input branch 130, a first output branch 131 and a second output branch 132.

[0139] The input branch 130, the first output branch 131 and the second output branch 132 converge within the cavity 13i of the branch compartment 13.

[0140] Specifically, the second end 110b extends from the input branch 130 into the cavity 13i, and multiple first wires 114 extending from the second end 110b extend into the first output branch 131, wherein the multiple first wires 114 and the multiple electrode rings 113 are coupled one-to-one.

[0141] Furthermore, the multiple first wires 114 extend from the first output branch 131 beyond the branch compartment 13, facilitating the connection of the multiple first wires 114 to the interfaces of other external devices (e.g., Type-C interfaces).

[0142] Similarly, the second end 110b extends from the input branch 130 into the cavity 13i, and the at least one second electrode 12 extending from the second end 110b extends into the second output branch 132.

[0143] Furthermore, the implantable device 100 may also include a signal transmission module 121, at least a portion of which extends into the second output branch 132 and is coupled to the at least one second electrode 12.

[0144] In some embodiments, the signal transmission module 121 may be a signal processing device and is directly connected to the second electrode 12.

[0145] In some embodiments, the signal transmission module 121 may be a signal processing device and is connected to the second electrode 12 via a flexible printed circuit (FPC).

[0146] Furthermore, the branch compartment 13 also includes a third output branch 133, which and the input branch 130 converge within the compartment 13i.

[0147] Furthermore, the implantable device also includes a push wire 14, which extends from the third output branch 133 through the cavity 13i into at least one built-in channel 111 at the second end 110b.

[0148] Specifically, the push wire 14 is physically connected to the at least one second electrode 12 and is used to guide the at least one second electrode 12 to move along the at least one built-in channel 111.

[0149] In practical applications, for example, at least one guide wire 123 can be twisted into a single strand to form a push wire 14.

[0150] For example, a push wire 14 with greater hardness and thickness than the guide wire 123 can be set separately, and at least one guide wire 123 is attached to the push wire 14, pushing the push wire 14 to drive all the guide mechanisms to move and complete the implantation.

[0151] By setting the push wire 14, a pushing force is generated on the second electrode 12, which assists the second electrode 12 to move within the built-in channel 111, thereby facilitating the implantation of the second electrode 12.

[0152] Furthermore, the implantable device 100 also includes a sealing and fixing mechanism 15, which is disposed on the third output branch 133 and sleeved on the push wire 14. The sealing and fixing mechanism 15 is used to support and hold the push wire 14 and seal the third output branch 133 after the push wire 14 is removed.

[0153] A sealing and fixing mechanism 15 is fitted onto the push wire 14 to keep the push wire 14 stable during the pushing operation. Furthermore, after the push wire 14 is withdrawn, it can be locked by the sealing and fixing mechanism 15 to seal the third output branch 133 corresponding to the push wire 14 and prevent the leakage of tissue fluid from the target brain region.

[0154] For example, refer to Figure 7 The sealing and fixing mechanism 15 may include a fixing bolt similar to a Luer needle cap, wherein the push wire 14 is loosely fitted, and the head near the cavity 13i is designed to open and close. As the fixing bolt is tightened toward the cavity 13i, the open and closeable head is gradually pressed radially until it clamps the push wire 14, thereby achieving fixation.

[0155] Furthermore, along the x-direction, the sealing and fixing mechanism 15 may also include a sealing ring 151 disposed between the fixing bolt and the chamber 13i. The sidewall of the chamber of the bifurcated chamber 13 for accommodating the sealing ring 151 may be conical. As the fixing bolt is tightened toward the chamber 13i, the sealing ring 151 is squeezed toward the sidewall with a smaller diameter, thereby achieving a sealing effect.

[0156] Furthermore, the implantable device 100 also includes a push handle 16, which is fixedly connected to the push wire 14 and is used to control the movement of the push wire 14.

[0157] Furthermore, a scale is printed on the push wire 14 to display the movement distance of the push wire 14.

[0158] This allows for precise control of the implantation depth, ensuring that the second electrode 12 reaches a sufficient implantation depth without being implanted too deeply and damaging the brain.

[0159] This implementation expands the extension position of the microelectrode by providing a lateral opening on the first electrode (i.e., the macroelectrode) for the second electrode (i.e., the microelectrode) to extend, improving the flexibility of implantation and allowing the implantable device to reach more areas of the target brain region. Furthermore, the inclusion of a bent, extended internal channel allows the second electrode to move along this channel and extend beyond the first electrode in a controllable direction. This facilitates precise implantation of the microelectrode at the desired location in the target brain region, expanding the detection range of neurons in the target brain region and obtaining a wider and / or more accurate range of neural signals. Thus, the microelectrode reliably and smoothly extends from the side of the macroelectrode, enriching the positions and angles that the implantable device can reach in the target brain region, and improving the range of neurons and monitoring effectiveness of EEG monitoring.

[0160] Reference Figure 8 , Figure 8 This is a flowchart illustrating a method for manufacturing an implantable device according to an embodiment of the present invention. This embodiment can be used to manufacture the aforementioned... Figures 1 to 7 The implantable device 100 is shown. The manufacturing method may include steps S101 to S104: Step S101: Provide at least one inner liner tube, wherein the inner liner tube is a hollow structure; Step S102: The at least one inner liner tube is placed into the conduit mold, wherein the inner liner tube is bent to a preset angle before or during placement, and the conduit mold is used for injection molding to form a conduit. Step S103: Provide multiple electrode rings and place them into the conduit mold; Step S104: A first electrode is formed by injection molding based on the conduit mold. The at least one inner liner tube is located inside the conduit and is adapted to form at least one built-in channel. The built-in channel is adapted to accommodate a second electrode. The plurality of electrode rings are sleeved on the conduit. An opening communicating with the built-in channel is opened on the wall of the conduit.

[0161] By forming a bent structure at a predetermined angle within the inner liner tube during manufacturing, a built-in channel with a predetermined angle is created within the macroelectrode for the movement of the microelectrode. This allows the second electrode to move along the built-in channel and extend beyond the first electrode at a predetermined angle, making the extension angle of the second electrode controllable. This facilitates the precise implantation of the microelectrode into the desired location within the target brain region, expanding the detection range of neurons in the target brain region and obtaining a wider range and / or more accurate neural signals. Consequently, the microelectrode reliably and smoothly extends from the side of the macroelectrode, enriching the positions and angles that the implantable device can reach in the target brain region, and improving the neuronal range and monitoring effect of EEG monitoring.

[0162] Furthermore, prior to step S102, the manufacturing method further includes bending the inner liner tube to the preset angle.

[0163] Specifically, this refers to bending the inner liner tube to the preset angle before it is placed into the conduit mold. In other words, the inner liner tube is placed into the conduit mold at the preset angle.

[0164] Furthermore, bending the inner liner tube to the preset angle includes bending the inner liner tube to the preset angle through heat treatment or stress deformation.

[0165] In practical applications, the preset angle to which at least one of the inner lining tubes is bent can be less than 30 degrees, 45 degrees or 60 degrees. The preset angles to which different inner lining tubes are bent can be the same or different.

[0166] Furthermore, the material of the inner liner is selected from at least one of the following: polymer materials and metal materials.

[0167] Furthermore, the catheter is made of silicone material.

[0168] Further, in step S102, placing the at least one inner liner tube into the conduit mold includes: injection molding a first part of the conduit based on the conduit mold, the first part having at least one receiving groove, wherein the extension direction of at least a portion of the receiving groove and the axial direction of the conduit have an angle with the preset angle; and placing the at least one inner liner tube into the at least one receiving groove respectively.

[0169] Wherein, the angle between the extension direction of at least a portion of the receiving groove and the axial direction of the conduit having the preset angle can be less than 30 degrees, 45 degrees or 60 degrees.

[0170] In some embodiments, there may be multiple receiving grooves, and the included angles between the different receiving grooves and the axial direction of the conduit may be the same or different.

[0171] In some embodiments, the plurality of receiving grooves may share the same portion, and the non-shared portions of the plurality of receiving grooves shall each have an angle with the axial direction of the conduit at the preset angle.

[0172] Furthermore, before placing the at least one inner liner tube into the at least one receiving groove, the extension direction of the inner liner tube is parallel to the axial direction of the conduit.

[0173] Specifically, before the at least one inner liner tube is placed into the at least one receiving groove, the at least one inner liner tube is straight. The inner liner tube has a certain degree of elasticity, and after being placed into the receiving groove, the included angle of the receiving groove causes the inner liner tube to deform. Thus, the inner liner tube is bent into a predetermined angle after being placed into the receiving groove. The predetermined angle to which the inner liner tube is bent is substantially the same as the predetermined angle of the receiving groove that receives the inner liner tube.

[0174] Furthermore, the opening is formed simultaneously during the step of injection molding the first electrode based on the conduit mold.

[0175] In one specific implementation, the conduit mold may have a protrusion corresponding to the opening, so that the opening is formed simultaneously during the step of injection molding the conduit mold to form the first electrode.

[0176] Furthermore, the conduit mold has pre-embedded holes corresponding to the opening.

[0177] In one specific implementation, a mold can be used to match the pre-embedded holes one by one to form a protrusion, thereby simultaneously forming the opening during the step of injection molding the first electrode in the conduit mold.

[0178] Different sizes and / or shapes of molds can be selected and matched with pre-embedded holes to form openings of different sizes and / or shapes to meet the needs of practical applications.

[0179] By selecting different numbers of molds to match with pre-embedded holes, the number and location of openings can be flexibly chosen to meet the needs of practical applications.

[0180] After injection molding is completed, the mold that matches the pre-embedded hole can be removed first, and then the subsequent demolding steps can be carried out, making demolding easier and improving the yield of finished products.

[0181] Furthermore, in step S104, after the first electrode is formed by injection molding based on the conduit mold, the manufacturing method further includes opening at least one opening in the wall of the conduit, wherein the at least one opening corresponds one-to-one with the at least one built-in channel.

[0182] Furthermore, the opening is formed on the tube wall between adjacent electrode rings, or the opening is formed on the electrode ring.

[0183] Furthermore, the manufacturing method further includes: inserting at least one second electrode into the at least one built-in channel to obtain the implantable device. In some embodiments, by performing the above... Figure 8 The steps of the illustrated embodiment can be used to prepare the following: Figure 1 The first electrode 11 of the implantable device 100 is shown. Then, in actual use (e.g., clinical application, when macro- and micro-electrode implantation is required), the procedure continues. Figure 9 The steps of the illustrated embodiment are to place the second electrode 12 into the first electrode 11 to obtain the following result: Figure 1 The implantable device 100 shown.

[0184] refer to Figure 9 , Figure 9 This is a flowchart of the process of placing at least one second electrode into at least one built-in channel in an embodiment of the present invention, which may specifically include steps S201 to S205: Step S201: Provide a branching compartment, the branching compartment including an input branch, a first output branch and a second output branch, the input branch, the first output branch and the second output branch converging within the compartment cavity of the branching compartment; Step S202: Incorporate the first electrode into the input branch and extend the first electrode from the first output branch through the cavity; Step S203: Provide a push wire, the front end of which is physically connected to the corresponding second electrode; Step S204: The tip of the push wire and the second electrode physically connected thereto are inserted together through the cavity into the at least one built-in channel, and the at least one second electrode corresponds one-to-one with the at least one built-in channel; Step S205: The rear end portion of the at least one second electrode that is not connected to the push wire is incorporated into the second output branch via the cavity.

[0185] Furthermore, the branch compartment also includes a third output branch, which intersects with the input branch within the compartment cavity.

[0186] In some embodiments, the manufacturing method of this embodiment further includes incorporating the push wire into the third output branch via the cavity, wherein the axial direction of the third output branch coincides with or is parallel to the axial direction of the input branch.

[0187] Furthermore, the push wire is pushed to move the at least one second electrode within the at least one built-in channel.

[0188] The second electrode moves along the corresponding built-in channel and can be delivered to a suitable position (e.g., the retracted position) by the pusher wire.

[0189] It should be understood that the term "and / or" in this article is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, or B existing alone. Additionally, the character " / " in this article indicates that the preceding and following related objects have an "or" relationship.

[0190] In the embodiments of this application, "multiple" refers to two or more.

[0191] The descriptions of "first," "second," etc., appearing in the embodiments of this application are for illustrative purposes and to distinguish the objects being described. They have no order and do not indicate any special limitation on the number of devices in the embodiments of this application, nor do they constitute any limitation on the embodiments of this application.

[0192] While the present invention has been disclosed above, it is not limited thereto. Any person skilled in the art can make various modifications and alterations without departing from the spirit and scope of the invention; therefore, the scope of protection of the present invention should be determined by the scope defined in the claims.

Claims

1. An implantable device, characterized in that, The implantable device includes: A first electrode, the first electrode comprising: A catheter having a first end and a second end opposite each other along an axial direction, the catheter having at least one internal channel, wherein the internal channel extends from the second end toward the first end and toward the wall of the catheter, the wall having an opening communicating with the internal channel; Multiple electrode rings are spaced apart along the axial direction of the conduit on the outer surface of the conduit, and the multiple electrode rings are closer to the first end than the second end; At least one second electrode, the at least one second electrode being housed within the at least one built-in channel, the second electrode including at least one electrode site, the second electrode being able to extend from an opening of a corresponding built-in channel.

2. The implantable device according to claim 1, characterized in that, The opening is formed on the tube wall between adjacent electrode rings, or the opening is formed on the electrode ring.

3. The implantable device according to claim 2, characterized in that, The conduit has multiple built-in channels, and the conduit wall has multiple openings communicating with the built-in channels. At least a portion of the multiple openings are opened on the conduit wall between two adjacent electrode rings and are located at different positions along the circumference of the conduit wall; or, at least a portion of the multiple openings are opened at different positions along the circumference of the same electrode ring.

4. The implantable device according to claim 1, characterized in that, The conduit has multiple built-in channels, and the conduit wall is correspondingly provided with multiple openings communicating with the built-in channels. At least a portion of the multiple openings are opened at different positions along the circumference of the conduit on the conduit wall, and / or, at least a portion of the multiple openings are opened at different positions along the axial direction of the conduit on the conduit wall.

5. The implantable device according to claim 1, characterized in that, The built-in channel includes an extension section extending axially along the conduit and a curved section extending obliquely from the extension section toward the conduit wall, the curved section being closer to the first end than the extension section.

6. The implantable device according to claim 5, characterized in that, The catheter has multiple internal channels, at least a portion of which share the same extension segment, or the multiple internal channels are independent of each other.

7. The implantable device according to claim 5, characterized in that, The angle between the extension direction of the curved section and the axial direction of the conduit is less than 30 degrees, 45 degrees, or 60 degrees.

8. The implantable device according to claim 5, characterized in that, The curved section is arc-shaped.

9. The implantable device according to claim 1, characterized in that, The diameter of the conduit is less than 1.8 mm, and / or the electrode ring is made of platinum, iridium, platinum alloy, iridium alloy, or platinum-iridium alloy.

10. The implantable device according to claim 1, characterized in that, The at least one second electrode and the at least one built-in channel correspond one-to-one, or at least two second electrodes are housed in the same built-in channel.

11. The implantable device according to claim 1, characterized in that, The first electrode further includes: multiple first wires, which are insulated from each other and embedded in the wall of the conduit, and the multiple first wires are coupled to the multiple electrode rings in a one-to-one correspondence.

12. The implantable device according to claim 1, characterized in that, The catheter also has a cavity extending along the axial direction of the catheter, and the first electrode further includes a plurality of first wires, which are insulated from each other and housed within the cavity and coupled one-to-one with the plurality of electrode rings.

13. The implantable device according to claim 12, characterized in that, The cavity and the at least one built-in channel are independent of each other, or the at least one built-in channel is housed within the cavity.

14. The implantable device according to claim 1, characterized in that, The implantable device also includes: At least one guiding mechanism, wherein the at least one guiding mechanism and the at least one second electrode are respectively housed within the at least one built-in channel.

15. The implantable device according to claim 14, characterized in that, The guidance mechanism includes: Guide pin, which is physically connected to the corresponding second electrode; A guide wire extends from the guide needle along a corresponding built-in channel toward the second end.

16. The implantable device according to claim 1, characterized in that, The implantable device also includes: A bifurcation compartment is disposed at the second end. The bifurcation compartment includes an input branch, a first output branch, and a second output branch. The input branch, the first output branch, and the second output branch converge within the compartment cavity of the bifurcation compartment. The second end extends from the input branch into the compartment cavity. Multiple first wires extending from the second end extend into the first output branch. At least one second electrode extending from the second end extends into the second output branch. The multiple first wires and the multiple electrode rings are coupled one-to-one.

17. The implantable device according to claim 16, characterized in that, The implantable device further includes a signal transmission module, at least a portion of which extends into the second output branch and is coupled to the at least one second electrode.

18. The implantable device according to claim 16, characterized in that, The plurality of first wires extend out of the branch compartment from the first output branch.

19. The implantable device according to claim 16, characterized in that, The bifurcation chamber also includes a third output branch, which intersects with the input branch within the chamber cavity. The implantable device also includes a push wire, which extends from the third output branch through the chamber cavity into at least one built-in channel at the second end. The push wire is physically connected to the at least one second electrode and is used to guide the at least one second electrode to move along the at least one built-in channel.

20. The implantable device according to claim 19, characterized in that, The implantable device further includes a sealing and fixing mechanism, which is disposed on the third output branch and sleeved on the push wire. The sealing and fixing mechanism is used to support and hold the push wire and seal the third output branch after the push wire is removed.

21. The implantable device according to claim 19, characterized in that, The implantable device further includes a push handle, which is fixedly connected to the push wire and is used to control the movement of the push wire.

22. The implantable device according to claim 19, characterized in that, The push wire is printed with graduations to indicate the distance the push wire travels.

23. The implantable device according to claim 1, characterized in that, The second electrode is movable between a retracted position and an extended position. When in the retracted position, the second electrode is housed within the corresponding built-in channel. When in the extended position, at least a portion of the second electrode extends out of the tube wall from the opening.

24. The implantable device according to claim 1, characterized in that, The first electrode includes an intracranial brain electrode, and the second electrode includes a flexible electrode.

25. A method for manufacturing an implantable device, characterized in that, The manufacturing method includes: Provide at least one inner liner tube, wherein the inner liner tube is a hollow structure; The at least one inner liner tube is placed into a conduit mold, wherein the inner liner tube is bent to a preset angle before or during placement, and the conduit mold is used for injection molding to form a conduit; Provide multiple electrode rings and place them into the conduit mold; The first electrode is formed by injection molding based on the conduit mold. The at least one inner liner tube is located inside the conduit and is adapted to form at least one built-in channel. The built-in channel is adapted to accommodate the second electrode. The plurality of electrode rings are sleeved on the conduit. An opening communicating with the built-in channel is opened on the wall of the conduit.

26. The manufacturing method according to claim 25, characterized in that, Before placing the at least one inner liner tube into the conduit mold, the manufacturing method further includes: The inner liner tube is bent to the preset angle.

27. The manufacturing method according to claim 26, characterized in that, The step of bending the inner liner tube to the preset angle includes bending the inner liner tube to the preset angle through heat treatment or stress deformation.

28. The manufacturing method according to claim 25, characterized in that, The material of the inner lining tube is selected from at least one of the following: polymer materials and metal materials.

29. The manufacturing method according to claim 25, characterized in that, The catheter is made of silicone material.

30. The manufacturing method according to claim 25, characterized in that, The step of placing the at least one inner liner tube into the conduit mold includes: The first part of the catheter is formed by injection molding based on the catheter mold. The first part has at least one receiving groove, wherein the extension direction of at least a portion of the receiving groove and the axial direction of the catheter have an angle of the preset angle. The at least one inner liner tube is placed into the at least one receiving tank.

31. The manufacturing method according to claim 30, characterized in that, Before the at least one inner liner is placed into the at least one receiving slot, the extension direction of the inner liner is parallel to the axial direction of the conduit.

32. The manufacturing method according to claim 25, characterized in that, The opening is formed simultaneously during the step of injection molding the first electrode based on the conduit mold.

33. The manufacturing method according to claim 32, characterized in that, The conduit mold has pre-embedded holes corresponding to the opening.

34. The manufacturing method according to claim 25, characterized in that, After the first electrode is formed by injection molding based on the conduit mold, the manufacturing method further includes: At least one opening is made in the wall of the conduit, and the at least one opening corresponds one-to-one with the at least one internal channel.

35. The manufacturing method according to claim 25, characterized in that, The opening is formed on the tube wall between adjacent electrode rings, or the opening is formed on the electrode ring.

36. The manufacturing method according to any one of claims 25 to 35, characterized in that, Also includes: At least one second electrode is inserted into the at least one built-in channel to obtain the implantable device.

37. The manufacturing method according to claim 36, characterized in that, The insertion of at least one second electrode into the at least one built-in channel includes: A bifurcation compartment is provided, the bifurcation compartment including an input branch, a first output branch and a second output branch, the input branch, the first output branch and the second output branch converging within the compartment cavity of the bifurcation compartment; The first electrode is incorporated into the input branch, and the first electrode extends from the first output branch via the cavity; A push wire is provided, the front end of which is physically connected to the corresponding second electrode; The tip of the push wire and the second electrode physically connected thereto are inserted together through the cavity into the at least one built-in channel, and the at least one second electrode corresponds one-to-one with the at least one built-in channel; The rear portion of the at least one second electrode that is not connected to the push wire is incorporated into the second output branch via the cavity.

38. The manufacturing method according to claim 37, characterized in that, The branched compartment further includes a third output branch, which converges with the input branch within the compartment cavity. The manufacturing method further includes: The push wire is fed into the third output branch via the chamber, and the axis of the third output branch coincides with or is parallel to the axis of the input branch. The push wire is pushed to move the at least one second electrode in the at least one built-in channel.

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