Electrode assembly

Abstract

The utility model discloses an electrode assembly. The electrode assembly comprises: an electrode wire, wherein the electrode wire comprises a guide wire and a stimulation end; the stimulation end is at least partially implanted into a target area, the stimulation end is provided with a plurality of stimulation contacts, and the stimulation contacts are electrically connected with the guide wire; the adjacent stimulation contacts are insulated and separated through an isolation structure, and the stimulation end is provided with at least one drug release channel; the medicine supply assembly comprises a medicine storage cavity and at least one medicine conveying channel, the medicine conveying channel is arranged in the electrode wire, one end of the medicine conveying channel is communicated with the medicine storage cavity, the medicine conveying channel is provided with at least one outer conveying channel, and the outer conveying channel is connected with the medicine release channel. According to the utility model, electric signal stimulation and drug release can be realized synchronously.

Description

Technical Field

[0001] This invention relates to the technical field of neural modulation and targeted drug delivery, and in particular to an electrode assembly. Background Technology

[0002] For motor disorders such as Parkinson's disease, epilepsy, dystonia, and spinal neuralgia, as well as mental illnesses such as depression, drug addiction, and obsessive-compulsive disorder, neurostimulation techniques (e.g., deep brain stimulation, spinal cord stimulation) are often used as supplementary or alternative treatments after drug therapy becomes less effective or develops resistance. Electrical stimulation modulates abnormal neural activity through specific frequency currents and has achieved significant therapeutic effects. However, single-mode electrical stimulation therapy still has limitations: for example, in late-stage Parkinson's disease patients with widespread dopaminergic neuronal degeneration, electrical stimulation is unlikely to completely improve non-motor symptoms (e.g., cognitive impairment); or for neuropathic pain accompanied by inflammation, simple electrical stimulation cannot block the abnormal release of neurotransmitters in the pain transmission pathway.

[0003] In existing technologies, to improve treatment efficacy, some clinical protocols employ a combination of electrical stimulation and drug therapy. For example, during electrical stimulation intervention, patients are required to take oral or injectable medications (e.g., levodopa, gabapentin). However, such protocols have the following significant drawbacks:

[0004] 1. Poor spatiotemporal coordination: There is a time delay and spatial misalignment between the effects of electrical stimulation and drug action. For example, spinal cord electrical stimulation needs to take effect immediately when pain signals are transmitted, while oral medications need to be digested and absorbed before entering the bloodstream, making precise synchronization difficult.

[0005] 2. Systemic side effects risk: Systemic administration (e.g., oral or intravenous injection) can cause the drug to spread to non-target areas, which may lead to gastrointestinal reactions, liver and kidney toxicity, etc., and the safety is particularly worrying for patients with chronic diseases who need long-term medication.

[0006] 3. Low patient compliance: Patients need to strictly follow the medication time and dosage, which can easily lead to fluctuations in efficacy due to missed doses or incorrect doses. In addition, frequent injection procedures increase the physiological and psychological burden.

[0007] To address at least one of the aforementioned technical problems, this application provides an electrode assembly. Utility Model Content

[0008] The purpose of this invention is to provide an electrode assembly that can simultaneously achieve electrical signal stimulation and drug release.

[0009] The objective of this utility model is achieved through the following technical solution:

[0010] On the one hand, this utility model provides an electrode assembly, including:

[0011] An electrode wire, comprising a guide wire and a stimulation end; the stimulation end is at least partially implanted in a target area, the stimulation end is provided with multiple stimulation contacts, the stimulation contacts are electrically connected to the guide wire; adjacent stimulation contacts are insulated and separated by an isolation structure, and the stimulation end is provided with at least one drug release channel;

[0012] A drug delivery assembly includes a drug storage chamber and at least one drug delivery channel. The drug delivery channel is disposed within the electrode wire, and one end of the drug delivery channel is connected to the drug storage chamber. The drug delivery channel is provided with at least one external transmission channel, which is connected to the drug release channel.

[0013] The beneficial effects of the above solution are as follows: This invention integrates the electrical stimulation contact and the drug delivery channel onto the same electrode, achieving simultaneous treatment of electrical stimulation and targeted drug delivery, reducing the risk of secondary surgery and improving treatment efficiency. By placing the drug delivery channel directly at the stimulation end, the drug can be precisely released to the area of ​​electrical stimulation, enhancing the synergistic effect (e.g., simultaneously releasing anticonvulsant drugs when inhibiting abnormal discharges in epileptic foci). Furthermore, by setting up an isolation structure to prevent current interference between adjacent contacts, and providing layout space for the drug delivery channel, excessive electrode diameter is avoided, reducing implantation trauma.

[0014] Furthermore, the stimulation end includes:

[0015] The outer layer of the stimulation end is composed of alternating stimulation contacts and isolation structures.

[0016] A filling layer that covers the guidewire and fills the internal space of the outer layer of the stimulation end;

[0017] The drug delivery channel is embedded in the filling layer.

[0018] The beneficial effects of the above solution are as follows: This utility model forms an outer layer by alternating stimulation contacts and isolation structures, which facilitates the customization of contact arrangement patterns (e.g., ring, spiral) to adapt to different brain region anatomical morphologies. In addition, by covering the guidewire with a filling layer and fixing the drug delivery channel, it prevents guidewire displacement from causing stimulation site shift, while isolating electrical signals and drug delivery paths to avoid mutual interference.

[0019] Furthermore, the stimulation end also includes an inner lumen tube, and the guidewire is wound around the inner lumen tube;

[0020] The filling layer is located between the inner lumen and the outer layer of the stimulation end.

[0021] The beneficial effects of the above solution are as follows: This utility model enhances the electrode's resistance to bending by forming a composite structure through the guidewire winding around the inner lumen, thus avoiding electrode deformation due to intracranial tissue resistance during implantation. Furthermore, the three-tiered structure of the inner lumen, filling layer, and outer layer achieves physical isolation between the guidewire, drug channel, and stimulation contact, reducing the risk of short circuits.

[0022] Furthermore, the drug delivery assembly includes multiple independent drug delivery channels, which are evenly distributed circumferentially in the filling layer, and the multiple drug delivery channels are used to deliver the same or different drugs.

[0023] The beneficial effects of the above solution are: This utility model supports the simultaneous delivery of antagonistic drugs (e.g., anti-inflammatory drugs + neurotrophic factors) through circumferentially distributed independent channels, or releases them on demand and in time-sharing, to meet complex treatment situations.

[0024] Furthermore, the drug delivery assembly also includes an infiltrator disposed within the drug release channel, enabling the drug to flow from the inside of the electrode to the outside of the electrode, and preventing tissue fluid from flowing from the outside of the electrode to the inside of the electrode.

[0025] The beneficial effects of the above solution are: the present invention allows for one-way sustained release of drugs through the permeator, while preventing tissue fluid backflow, avoiding channel blockage (e.g., crystallization caused by cerebrospinal fluid backflow) and the risk of infection caused by microbial invasion.

[0026] Furthermore, the permeate is a permeable membrane and / or a permeable sponge.

[0027] Furthermore, the drug delivery assembly also includes:

[0028] A control valve is connected to the output end of the drug storage chamber.

[0029] The beneficial effects of the above solution are: the present invention can realize remote wireless control through the control valve, and can administer drugs according to the treatment course at fixed times and in fixed quantities or in response to the treatment.

[0030] Furthermore, the drug delivery assembly also includes:

[0031] A transfer tube, one end of which is connected to the input end of the drug delivery channel, and the other end of which is connected to the output end of the drug storage chamber.

[0032] Furthermore, the electrode assembly also includes an electrode fixing device, the electrode fixing device comprising:

[0033] The cranial foramen ring has a lower surface with an arc that matches the curvature of the skull, a first through hole on the bottom surface of the cranial foramen ring, an electrode wire extending into the skull from the first through hole, and a second mounting port on the top surface of the cranial foramen ring.

[0034] An electrode lock is provided with a fixing part for holding the electrode wire. The electrode lock is embedded in the second mounting opening, and a drug storage cavity is provided between the electrode lock and the cranial foramen ring.

[0035] The beneficial effects of the above solution are: This utility model integrates the drug storage cavity with the cranial foramen ring and electrode lock, reducing the volume of additional subcutaneous implants and lowering the risk of rejection and skin breakdown. Furthermore, the curvature of the bottom surface of the cranial foramen ring matches the curvature of the skull, ensuring a stable fit and preventing postoperative electrode displacement.

[0036] Furthermore, the electrode lock is provided with a drug filling hole and a sealing plug that matches the drug filling hole, and the drug filling hole is connected to the drug storage cavity.

[0037] The beneficial effect of the above solution is that the present invention can replenish drugs through the drug filling hole, avoiding the need for craniotomy to replace the drug storage device.

[0038] Compared with the prior art, the beneficial effects of this utility model include at least the following:

[0039] This invention integrates the electrical stimulation contact and the drug delivery channel onto the same electrode, enabling simultaneous treatment with electrical stimulation and targeted drug delivery, reducing the risk of secondary surgery and improving treatment efficiency. By placing the drug delivery channel directly at the stimulation end, the drug can be precisely released to the area of ​​electrical stimulation, enhancing the synergistic effect (e.g., simultaneously releasing anticonvulsant drugs when suppressing abnormal discharges in epileptic foci). Furthermore, the isolation structure prevents current interference between adjacent contacts while providing layout space for the drug delivery channel, avoiding excessive electrode diameter increase and reducing implantation trauma. Attached Figure Description

[0040] Figure 1 This is a schematic diagram illustrating an application of the electrode assembly according to an embodiment of the present invention.

[0041] Figure 2 This is a schematic diagram of the structure of an electrode assembly according to an embodiment of the present invention.

[0042] Figure 3 This is a partial structural schematic diagram of the electrode assembly according to an embodiment of the present invention.

[0043] Figure 4 This is a utility model Figure 3 Cross-sectional view.

[0044] Figure 5 This is a utility model Figure 4 A magnified view of part A in the image.

[0045] In the diagram: 11. Electrode lead wire; 111. Guide wire; 112. Stimulation end; 1120. Outer layer of stimulation end; 1121. Stimulation contact; 1122. Isolation structure; 1123. Drug release channel; 1124. Filling layer; 1125. Inner lumen tube; 113. Middle section; 114. Plug end; 115. Guide head; 12. Drug supply assembly; 121. Drug storage chamber; 122. Drug delivery channel; 1221. External delivery channel; 123. Adaptor tube; 13. Electrode fixing device; 131. Foramen ring; 1311. Lower surface; 1312. First through hole; 1313. Second mounting port; 132. Electrode lock; 1321. Fixing part; 1322. Drug filling hole. Detailed Implementation

[0046] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. However, these exemplary embodiments can be implemented in many forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided to make the present invention more comprehensive and complete, and to fully convey the concept of the exemplary embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and therefore repeated descriptions of them will be omitted.

[0047] The terms used to describe position and direction in this utility model are illustrated with the accompanying drawings, but changes can be made as needed, and all such changes are included within the scope of protection of this utility model.

[0048] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. However, these exemplary embodiments can be implemented in many forms and should not be construed as limited to the embodiments set forth herein; rather, they are provided to make the invention more comprehensive and complete, and to fully convey the concept of the exemplary embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and therefore repeated descriptions of them will be omitted.

[0049] The terms used to express position and direction in this invention are illustrated with reference to the accompanying drawings, but changes can be made as needed, and all such changes are included within the scope of protection of this invention.

[0050] Below, we will first briefly describe one application area of ​​the present invention (i.e., implantable devices). An implantable neurostimulation system (an implantable medical system) mainly includes: a stimulator implanted in the patient's body and a programmed device placed outside the patient's body. Existing neuromodulation technology mainly involves implanting electrodes into specific structures (i.e., target points) within the body through stereotactic surgery, and then having the stimulator implanted in the patient's body send discharge pulses to the target points via the electrodes, thereby modulating the electrical activity and function of the corresponding neural structures and networks, thereby improving symptoms and relieving pain. The stimulator can be any one of an implantable neurostimulation device, an implantable cardiac stimulation system (also known as a pacemaker), an implantable drug delivery system (IDDS), or a lead adapter. Implantable neurostimulation devices include, for example, deep brain stimulation (DBS), cortical nerve stimulation (CNS), spinal cord stimulation (SCS), sacral nerve stimulation (SNS), and vagus nerve stimulation (VNS).

[0051] In some embodiments, the stimulator may include: an implantable pulse generator (IPG), electrode leads 11, and an extension lead disposed between the implantable pulse generator and the electrode leads 11, through which data interaction between the implantable pulse generator and the electrode leads 11 is achieved. The implantable pulse generator is disposed within the patient's body. Responding to programmed commands sent by a programmable device, controllable electrical stimulation energy is provided to the body's tissues via a sealed battery and circuitry. One or two controllable electrical stimuli are delivered to specific areas of the body's tissues via the implanted extension lead and electrode leads 11. The extension lead, used in conjunction with the implantable pulse generator, serves as a medium for transmitting electrical stimulation signals, conveying the electrical stimulation signals generated by the implantable pulse generator to the electrode leads 11. The electrode leads 11 deliver electrical stimulation to specific areas of the body's tissues through their electrode contacts. The stimulator is provided with one or more electrode leads 11 on one or both sides, and each electrode lead 11 has multiple electrode contacts.

[0052] In other embodiments, the stimulator may consist only of an implantable pulse generator and an electrode lead 11. The implantable pulse generator may be embedded in the patient's skull, and the electrode lead 11 may be implanted inside the patient's skull. In this case, the implantable pulse generator and the electrode lead 11 are directly connected, without the need for extension wires.

[0053] The electrode lead 11 can be a neurostimulation electrode, delivering electrical stimulation to a specific area of ​​tissue within the body via multiple electrode contacts. The stimulator has one or more electrode leads 11 on one or both sides, each with multiple electrode contacts arranged uniformly or non-uniformly around the circumference of the electrode lead 11. As an example, the electrode contacts can be arranged in a 4x3 array (a total of 12 electrode contacts) around the circumference of the electrode lead 11. The electrode contacts can include stimulation contacts 1121 and / or acquisition contacts. The electrode contacts can be, for example, sheet-like, ring-like, or dot-like shapes.

[0054] In some cases, the stimulated tissue can be the patient's brain tissue, and the stimulated site can be a specific area of ​​the brain tissue. The stimulated site generally differs depending on the patient's disease type, the number of stimulation contacts 1121 (single-source or multi-source), the application of one or more specific electrical stimulation signals (single-channel or multi-channel), and the stimulation parameter data. It can be assumed that using multiple stimulation contacts 1121 (multi-source, multi-channel) will generate a larger amount of data compared to using a single-source, single-channel approach.

[0055] This invention does not limit the types of diseases to which it is applicable, but can include those applicable to deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation. Specifically, DBS can be used to treat or manage diseases including, but not limited to: spastic disorders (e.g., epilepsy), pain, migraines, mental illnesses (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety disorders, post-traumatic stress disorder, mild depression, obsessive-compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental state disorders, mobility disorders (e.g., essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease, drug addiction, autism, or other neurological or psychiatric disorders and impairments.

[0056] Stimulation parameters may include: stimulation frequency (e.g., the number of electrical stimulation pulse width signals per unit time 1 second, in Hz), pulse width (the duration of each pulse width, in μs), current amplitude (generally expressed as voltage, i.e., the intensity of each pulse width, in V), timing (e.g., continuous or triggered), stimulation mode (including one or more of current mode, voltage mode, timed stimulation mode, and cyclic stimulation mode), physician control upper and lower limits (the range that physicians can adjust), and patient control upper and lower limits (the range that patients can adjust independently).

[0057] This invention introduces an electrode assembly. Traditional neuromodulation devices, such as deep brain stimulation electrodes, intervene in neural activity solely through electrical signals. This application integrates the electrical stimulation contact 1121 and the drug release channel 1123 within the same electrode lead 11, forming an electrode assembly capable of dual-modal therapy. Compared to existing technologies, it eliminates the need for additional drug pumps or catheters, avoiding secondary surgery and reducing infection risks and medical costs. Furthermore, the electrical stimulation and drug release act on the same target, avoiding the efficacy attenuation caused by spatial misalignment in traditional separate devices. For example, in epilepsy treatment, electrical stimulation inhibits abnormal discharges while simultaneously releasing antiepileptic drugs (e.g., sodium valproate) locally through the drug release channel 1123, blocking lesion spread. In Parkinson's disease treatment, deep brain stimulation (DBS) modulates neural circuits in the basal ganglia region, simultaneously releasing dopamine prodrugs (e.g., levodopa), compensating for the limitations of electrical stimulation on non-motor symptoms.

[0058] refer to Figure 2 The electrode assembly of this invention includes: an electrode lead wire 11 and a drug delivery assembly 12. Furthermore, the electrode assembly of this invention may also include: an electrode fixing device 13.

[0059] The electrode lead 11 of this invention includes a guide wire 111 and a stimulation end 112. Further, the electrode lead 11 of this invention may also include a middle section 113 and a plug end 114. Even further, the electrode lead 11 of this invention may also include a guide head 115.

[0060] In some embodiments, the stimulator is connected to a plug end 114, which is connected to an intermediate section 113, and the intermediate section 113 is connected to a stimulation end 112. (See reference) Figure 1 The stimulation end 112 and part of the intermediate segment 113 are located in the intracranial segment, while the remaining part of the intermediate segment 113 and the plug end 114 are located in the extracranial segment. In addition, the guide head 115 is connected to the first end of the stimulation end 112 and forms a sealing structure with the stimulation end 112 to prevent tissue fluid from entering the electrode lead 11.

[0061] In practical applications, the stimulation end 112 is at least partially implanted in the target area. The stimulation end 112 has multiple stimulation contacts 1121, and the plug end 114 has multiple connecting contacts. One end of the guide wire 111 is electrically connected to the stimulation contacts 1121, and the other end of the guide wire 111 is electrically connected to the connecting contacts, ensuring that each stimulation contact 1121 and each connecting contact is electrically connected. The multiple guide wires 111 are mutually insulated. Further, refer to... Figure 3 Adjacent stimulation contacts 1121 are insulated and separated by an isolation structure 1122, and the stimulation end 112 is provided with at least one drug release channel 1123.

[0062] In some embodiments, to adapt to different brain region anatomical morphologies, both the stimulation contact 1121 and the isolation structure 1122 can be dot-shaped, circular, rectangular, ring-shaped, or other irregular structures. Preferably, the stimulation contact 1121 is a rectangular or ring-shaped structure, and the isolation structure 1122 is a ring-shaped structure to isolate adjacent stimulation contacts 1121. It is worth noting that the insulating isolation structure 1122 between adjacent stimulation contacts 1121 not only prevents current diffusion and avoids overstimulation of healthy tissue, but also serves as physical support for the drug release channel 1123.

[0063] In some embodiments, the drug release channel 1123 is formed on the isolation structure 1122. Preferably, each isolation structure 1122 has a drug release channel 1123 for releasing drugs around the stimulation point. Furthermore, the number of drug release channels 1123 can be flexibly configured according to treatment needs; for example, a single channel can be used for local sustained release of antibiotics, while multiple channels can support combination therapy of anticancer drugs.

[0064] The stimulation end 112 of this invention includes an outer layer 1120 and a filling layer 1124. Further, the stimulation end 112 of this invention may also include an inner lumen 1125.

[0065] The outer layer 1120 of this invention is composed of alternating stimulation contacts 1121 and isolation structures 1122. The inner lumen tube 1125 is disposed inside the outer layer 1120, and the guide wire 111 is wound around the inner lumen tube 1125. The filling layer 1124 is located between the inner lumen tube 1125 and the outer layer 1120, and covers the guide wire 111 and fills the internal space of the outer layer 1120.

[0066] In application, the guidewire 111 is wound around the inner lumen tube 1125 to form a composite structure, which enhances the electrode's resistance to bending and avoids electrode deformation due to intracranial tissue resistance during implantation. In addition, the three-level structure of the inner lumen tube 1125-filling layer 1124-outer layer 1120 achieves physical isolation between the guidewire 111, the drug channel and the stimulation contact 1121, reducing the risk of short circuits and improving long-term reliability.

[0067] refer to Figure 4and Figure 5 The drug supply assembly 12 of this invention includes a drug storage chamber 121 and at least one drug delivery channel 122. Further, the drug supply assembly 12 of this invention may also include a permeator and a transfer tube 123. Even further, the drug supply assembly 12 of this invention may also include a control valve.

[0068] In application, the drug delivery channel 122 is used to deliver drugs from the outside of the electrode to the inside of the electrode, so as to reach the stimulation end 112 and act on the target area.

[0069] The drug delivery channel 122 of this utility model is set inside the electrode wire 11.

[0070] In application, the drug delivery channel 122 is pre-embedded in the filling layer 1124. The drug storage cavity 121 is directly connected to the drug release channel 1123 of the stimulation end 112 through the pre-embedded drug delivery channel 122, eliminating the risk of dislodgement and twisting that is common with traditional external catheters.

[0071] In some embodiments, by covering the guidewire 111 with the filling layer 1124 and fixing the drug delivery channel 122, it is possible to prevent the guidewire 111 from shifting and causing the stimulation site to deviate, while isolating the electrical signal from the drug delivery path to avoid mutual interference.

[0072] In practical applications, one end of the drug delivery channel 122 is connected to the drug storage cavity 121. The drug delivery channel 122 is provided with at least one external transmission channel 1221, which is connected to the drug release channel 1123.

[0073] As can be seen, the drug delivery channel 1123 of this invention is directly located at the stimulation end 112 and is connected to the drug delivery channel 122 through the external transmission channel 1221, realizing "point-to-point" drug delivery. It can bypass the blood-brain barrier and directly deliver large molecule drugs (e.g., monoclonal antibodies, neurotrophic factors) to the lesion, avoiding the inefficiency and toxic side effects of systemic administration.

[0074] In some embodiments, the drug delivery assembly 12 of this invention includes multiple independent drug delivery channels 122, which are uniformly distributed circumferentially in the filling layer 1124. These multiple channels 122 are used to deliver the same or different drugs. Specifically, the flow rate of different channels can be independently adjusted to achieve a gradient distribution of drug concentration, for example, differentiated drug delivery between the tumor periphery and center, improving efficacy and reducing side effects.

[0075] In some embodiments, the drug delivery channel 122 is made of a bio-inert material (e.g., polyether ether ketone - PEEK), which has both corrosion resistance and low protein adsorption properties to prevent drug denaturation or channel blockage.

[0076] The permeator of this invention is disposed within the drug release channel 1123, enabling the drug to flow from the inside of the electrode to the outside while preventing tissue fluid from flowing from the outside of the electrode to the inside. This avoids channel blockage, such as the risk of crystallization and microbial invasion caused by cerebrospinal fluid backflow. Furthermore, the passive permeation mechanism requires no external energy drive, making it suitable for long-term implantation scenarios and reducing system complexity.

[0077] In application, at least one external delivery through hole is provided on the drug release channel 1123, and the external delivery through hole extends to form a connecting pipe. The connecting pipe is connected to the drug release channel 1123, and the permeate is disposed in the connecting pipe.

[0078] In practical applications, the permeate is a permeable membrane and / or a permeable sponge. The permeable membrane (e.g., a semi-permeable membrane) provides a stable diffusion rate, while the permeable sponge (e.g., a porous material) enables pulsed release; the combination of the two can match pharmacokinetic characteristics. Furthermore, the membrane and sponge materials can be selected from hydrophilic or hydrophobic polymers to suit different drug physicochemical properties (e.g., lipid-soluble neurotransmitters or water-soluble protein formulations).

[0079] One end of the adapter tube 123 of this utility model is connected to the input end of the drug delivery channel 122, and the other end of the adapter tube 123 is connected to the output end of the drug storage chamber 121.

[0080] In application, one end of the adapter 123 is prefabricated in the middle section 113 of the electrode wire 11, and the other end of the adapter 123 passes through the outer layer 1120 of the middle section 113.

[0081] In some embodiments, when the prefabricated adapter 123 penetrates the outer layer 1120 of the electrode, a biocompatible sealant is used to ensure no leakage after long-term implantation and to prevent drugs from leaking into non-target areas.

[0082] In practical applications, adapter pipe 123 is an L-shaped pipe.

[0083] In some embodiments, the adapter tube 123 uses a standardized interface, such as a Luer connector, to facilitate intraoperative connection / replacement of the drug storage chamber 121 and reduce assembly difficulty.

[0084] The control valve of this utility model is connected to the output end of the drug storage chamber 121.

[0085] In application, the opening of the control valve can be controlled based on the electrical stimulation feedback (e.g., impedance change) of the target area, and the drug release dose can be adjusted in real time to control the drug delivery to the target area.

[0086] In some embodiments, a control valve is used to generate a constant driving force with an elastic diaphragm, ensuring continuous drug delivery without an external pump (especially suitable for chronic disease management requiring long-term administration over months to years).

[0087] refer to Figure 4 and Figure 5 The electrode fixing device 13 of this utility model includes: cranial foramen ring 131 and electrode lock 132.

[0088] The lower surface 1311 of the cranial foramen ring 131 of this utility model is provided with an arc that matches the curvature of the skull. The bottom surface of the cranial foramen ring 131 is provided with a first through hole 1312. The electrode wire 11 extends into the skull from the first through hole 1312. The top surface of the cranial foramen ring 131 is provided with a second mounting port 1313.

[0089] The electrode lock 132 of this utility model has a fixing part 1321, which is used to hold the electrode wire 11. The electrode lock 132 is embedded in the second mounting port 1313, and a drug storage cavity 121 is provided between the electrode lock 132 and the cranial foramen ring 131.

[0090] In application, the fixing part 1321 can be a fixing groove that matches the electrode wire 11.

[0091] In practical applications, the electrode lock 132 is provided with a drug filling hole 1322 and a sealing plug that matches the drug filling hole 1322. The drug filling hole 1322 is connected to the drug storage cavity 121. Preferably, a sealing ring is provided between the sealing plug and the drug filling hole 1322.

[0092] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and alterations to the above embodiments within the scope of the present invention without departing from the principles and spirit of the present invention, and all such changes should fall within the protection scope of the claims of the present invention.

Claims

1. An electrode assembly, characterized in that, include: An electrode wire (11) includes a guide wire (111) and a stimulation end (112); the stimulation end (112) is at least partially implanted in the target area, the stimulation end (112) is provided with a plurality of stimulation contacts (1121), the stimulation contacts (1121) are electrically connected to the guide wire (111); adjacent stimulation contacts (1121) are insulated and separated by an isolation structure (1122), and the stimulation end (112) is provided with at least one drug release channel (1123); The drug delivery assembly (12) includes a drug storage chamber (121) and at least one drug delivery channel (122). The drug delivery channel (122) is disposed in the electrode wire (11). One end of the drug delivery channel (122) is connected to the drug storage chamber (121). The drug delivery channel (122) is provided with at least one external transmission channel (1221), which is connected to the drug release channel (1123).

2. The electrode assembly according to claim 1, characterized in that, The stimulation end (112) includes: The outer layer (1120) is composed of alternating stimulating contacts (1121) and isolation structures (1122); A filler layer (1124) covers the guidewire (111) and fills the internal space of the outer layer (1120); The drug delivery channel (122) is embedded in the filling layer (1124).

3. The electrode assembly according to claim 2, characterized in that, The stimulation end (112) further includes an inner lumen tube (1125), and the guide wire (111) is wound around the inner lumen tube (1125); The filling layer (1124) is located between the inner tube (1125) and the outer layer (1120).

4. The electrode assembly according to claim 3, characterized in that, The drug delivery assembly (12) includes multiple independent drug delivery channels (122), which are evenly distributed circumferentially in the filling layer (1124). The multiple drug delivery channels (122) are used to deliver the same or different drugs.

5. The electrode assembly according to claim 1, characterized in that, The drug delivery assembly (12) also includes an infiltrator disposed within the drug release channel (1123) to allow the drug to flow from the inside of the electrode to the outside of the electrode and to prevent tissue fluid from flowing from the outside of the electrode to the inside of the electrode.

6. The electrode assembly according to claim 5, characterized in that, The permeate is a permeable membrane and / or a permeable sponge.

7. The electrode assembly according to claim 1, characterized in that, The drug delivery assembly (12) also includes: A control valve is connected to the output of the drug storage chamber (121).

8. The electrode assembly according to claim 1, characterized in that, The drug delivery assembly (12) also includes: A transfer tube (123) is provided, one end of which is connected to the input end of the drug delivery channel (122), and the other end of which is connected to the output end of the drug storage chamber (121).

9. The electrode assembly according to claim 1, characterized in that, The electrode assembly further includes an electrode fixing device (13), the electrode fixing device (13) comprising: A cranial foramen ring (131) has a lower surface (1311) with an arc matching the curvature of the skull, a first through hole (1312) on the bottom surface of the cranial foramen ring (131), an electrode wire (11) extending from the first through hole (1312) into the cranium, and a second mounting port (1313) on the top surface of the cranial foramen ring (131). An electrode lock (132) is provided with a fixing part (1321) for holding the electrode wire (11). The electrode lock (132) is embedded in the second mounting port (1313). A drug storage cavity (121) is provided between the electrode lock (132) and the cranial foramen ring (131).

10. The electrode assembly according to claim 9, characterized in that, The electrode lock (132) is provided with a drug filling hole (1322) and a sealing plug that matches the drug filling hole (1322). The drug filling hole (1322) is connected to the drug storage cavity (121).

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