Flexible stimulating electrode for magnetic control guided implantation

Abstract

The invention discloses a flexible stimulating electrode for magnetic control guide implantation, which comprises an electrode wire main body, a conical electrode tip is arranged at the end part of the electrode wire main body, and a cavity is formed in the electrode wire main body; the plurality of stimulation contacts are arranged at equal intervals along the length direction of the electrode wire main body; the multiple signal recording contacts are arranged in the length direction of the electrode wire body at equal intervals; the conductive wire is electrically connected with each stimulation contact and the signal recording contact; the guide magnet is mounted in the cavity of the electrode wire main body; and the magnetic control system is used for generating a magnetic field. The magnetic field generated by the magnetic control system can apply magnetic force to the electrode wire main body inserted into the body of a patient, so that the position of the electrode wire main body is finely adjusted; through the stimulation contacts arranged on the electrode wire body, different areas of a patient can be electrically stimulated, and output current is recorded through the signal recording contacts, so that the stimulation intensity of the stimulation contacts is controlled in a closed-loop mode, and precise stimulation is achieved.

Description

Technical Field

[0001] The present application relates to the field of medical technology, and in particular to a flexible stimulation electrode implanted under magnetic control guidance. Background Art

[0002] Deep brain stimulation is an invasive neuromodulation technology that electrically stimulates the target area by implanting electrodes and releasing pulsed currents with specific parameters (such as frequency, pulse width, current intensity, etc.). This technology is mainly used to treat neurological diseases that are difficult to control with drugs or have developed drug resistance, especially movement disorders and mental illnesses. In the treatment of Parkinson's disease, deep brain stimulation is widely used in patients in the middle and late stages, especially for symptoms such as bradykinesia and rigidity. In clinical practice, the subthalamic nucleus or the medial globus pallidus is usually selected as the stimulation target, and continuous high-frequency electrical stimulation (about 130-180Hz) is applied.

[0003] Currently, most deep brain stimulation electrodes used in clinical practice employ a multipolar design, typically containing four or more contacts, allowing for independent adjustment of stimulation to different regions, thereby optimizing therapeutic efficacy. However, because the electrodes have a single, long-axis structure, the intraoperative approach for subthalamic nucleus stimulation implantation, for example, is typically through the skull top, with insertion at an angle relative to the nucleus. While this maximizes the number of stimulation contacts and increases the contact area between the electrode and the nucleus, the lack of angle adjustment means that some contacts may be exposed outside the target area after implantation. This makes it difficult to localize the stimulation current within the target nucleus, potentially exposing non-target tissue to unwanted stimulation, leading to side effects or adverse reactions. The accuracy and stability of electrode implantation remain challenges. Despite precise implantation using stereotactic techniques, individual anatomical variations and subtle intraoperative deviations can cause electrode position shift, compromising targeted stimulation. Furthermore, after implantation, physiological movement or morphological changes in brain tissue (such as brain atrophy) can cause electrode position to shift over time, impacting long-term efficacy. For patients requiring long-term, continuous stimulation, electrode position shift may lead to decreased efficacy, and reimplantation surgery increases surgical risk and patient burden.

[0004] For patients with mid- to late-stage Parkinson's disease, the lateral subthalamic nucleus is usually selected as the optimal stimulation target. However, as treatment progresses and the disease progresses, pathological activity within the neural network may migrate, causing the initially set stimulation target to no longer be applicable. The stimulation position of the currently used electrodes can only be adjusted along the long axis of the electrode, such as by selecting the stimulation point through directional electrical stimulation. However, due to the long strip-like anatomical structure of the subthalamic nucleus and the limited implantation angle, it is impossible to effectively adjust the stimulation of other areas within the nucleus. This greatly limits the flexibility and effectiveness of long-term treatment. Summary of the Invention

[0005] This application aims to solve at least one of the technical problems existing in the prior art. To this end, this application proposes a magnetically guided implantable flexible stimulation electrode that can guide the stimulation electrode to a designated area for precise stimulation and can also be fine-tuned during surgery and subsequent treatment to adapt to changes in the stimulation location.

[0006] According to the first aspect of the present application, a flexible stimulation electrode for magnetically guided implantation includes:

[0007] An electrode wire body, the end of which is provided with a conical electrode tip, and the interior of the electrode wire body is provided with a cavity;

[0008] There are multiple stimulation contacts, which are equidistantly arranged along the length of the electrode wire body;

[0009] There are multiple signal recording contacts, which are equidistantly arranged along the length of the electrode wire body;

[0010] a conductive wire electrically connected to each of the stimulation contacts and the signal recording contacts, wherein the conductive wire is connected to an external electronic device;

[0011] a guide magnet installed in the cavity of the electrode wire body;

[0012] a magnetic control system, which is arranged outside the electrode wire body and is used to generate a magnetic field;

[0013] The guiding magnet is affected by the magnetic field generated by the magnetron system, and the magnetic field force acts on the electrode wire body through the guiding magnet to fine-tune the position of the electrode wire body.

[0014] The flexible stimulation electrode implanted under magnetic control guidance according to the embodiment of the present application has at least the following beneficial effects: the magnetic field generated by the magnetic control system can apply magnetic force to the electrode wire body that has been inserted into the patient's body, thereby fine-tuning the position of the electrode wire body; through the multiple stimulation contacts provided on the electrode wire body, different areas of the patient can be electrically stimulated, and the output current is recorded through the signal recording contacts, thereby closed-loop controlling the stimulation intensity of the stimulation contacts to achieve precise stimulation.

[0015] According to some embodiments of the present application, the guiding magnet is located at the tip of the electrode.

[0016] According to some embodiments of the present application, the magnetically guided implanted flexible stimulation electrode also includes a guide wire, one end of which is connected to the guiding magnet, and the other end of the guide wire extends from the cavity of the electrode wire body, and the guide wire is used to be pulled by medical staff to manually adjust the position of the electrode wire body.

[0017] According to some embodiments of the present application, the guide wire is detachably connected to the guide magnet, and the guide wire can be pulled out from the electrode wire body.

[0018] According to some embodiments of the present application, there are multiple conductive threads, and they are electrically connected to the stimulation contacts and the signal recording contacts in a one-to-one correspondence.

[0019] According to some embodiments of the present application, the stimulation contacts are provided in at least two groups, and the stimulation contacts in each group are distributed in a circular array around the central axis of the electrode wire body.

[0020] According to some embodiments of the present application, the signal recording contacts are located between each group of the stimulation contacts.

[0021] According to some embodiments of the present application, the number of the signal recording contacts and the number of the stimulation contacts in each group are both 4.

[0022] According to some embodiments of the present application, the electrode wire body is a flexible part.

[0023] According to some embodiments of the present application, the electrode wire body is cylindrical, and the electrode tip is conical.

[0024] Additional aspects and advantages of the present application will be given in part in the description below, and in part will become obvious from the description below, or will be learned through practice of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The accompanying drawings are used to provide a further understanding of the technical solutions disclosed in this application and constitute a part of the specification. Together with the embodiments disclosed in this application, they are used to explain the technical solutions disclosed in this application and do not constitute a limitation on the technical solutions disclosed in this application.

[0026] Figure 1 This is a cross-sectional view of a flexible stimulation electrode implanted under magnetic guidance according to an embodiment of the present application;

[0027] Figure 2 This is a schematic diagram of the connection between the stimulation contacts, signal recording contacts, and conductive wires in the flexible stimulation electrode implanted under magnetic guidance according to an embodiment of the present application;

[0028] Figure 3 This is a working diagram of a flexible stimulation electrode implanted under magnetic guidance according to an embodiment of the present application;

[0029] Figure 4 This is a workflow diagram of the magnetically guided implantation of flexible stimulation electrodes according to an embodiment of the present application.

[0030] Reference numerals: 100 - electrode wire body, 110 - electrode tip, 200 - stimulation contact, 300 - signal recording contact, 400 - conductive wire, 500 - guiding magnet, 600 - magnetic control system, 700 - guide wire. DETAILED DESCRIPTION

[0031] The following describes in detail embodiments of the present application. Examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present application and are not to be construed as limiting the present application.

[0032] In the description of this application, it should be understood that descriptions involving orientations, such as up, down, front, back, left, right, etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, they cannot be understood as limitations on this application.

[0033] In the description of this application, "several" means more than one, "plurality" means more than two, "greater than," "less than," and "exceed" are understood to exclude the number itself, while "above," "below," and "within" are understood to include the number itself. The use of "first" and "second" in the description is solely for the purpose of distinguishing technical features and should not be construed as indicating or implying relative importance, implicitly specifying the number of the indicated technical features, or implicitly specifying the order of the indicated technical features.

[0034] In the description of this application, unless otherwise clearly defined, terms such as setting, installing, and connecting should be understood in a broad sense, and technicians in the relevant technical field can reasonably determine the specific meanings of the above terms in this application based on the specific content of the technical solution.

[0035] In the description of this application, reference to the terms "one embodiment," "some embodiments," "illustrative embodiments," "examples," "specific examples," or "some examples" means that the specific features, structures, materials, or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of this application. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described can be combined in any appropriate manner in any one or more embodiments or examples.

[0036] Deep brain stimulation is an invasive neuromodulation technology that electrically stimulates the target area by implanting electrodes and releasing pulsed currents with specific parameters (such as frequency, pulse width, current intensity, etc.). This technology is mainly used to treat neurological diseases that are difficult to control with drugs or have developed drug resistance, especially movement disorders and mental illnesses. In the treatment of Parkinson's disease, deep brain stimulation is widely used in patients in the middle and late stages, especially for symptoms such as bradykinesia and rigidity. In clinical practice, the subthalamic nucleus or the medial globus pallidus is usually selected as the stimulation target, and continuous high-frequency electrical stimulation (about 130-180Hz) is applied.

[0037] Currently, most deep brain stimulation electrodes used in clinical practice employ a multipolar design, typically containing four or more contacts, allowing for independent adjustment of stimulation to different regions, thereby optimizing therapeutic efficacy. However, because the electrodes have a single, long-axis structure, the intraoperative approach for subthalamic nucleus stimulation implantation, for example, is typically through the skull top, with insertion at an angle relative to the nucleus. While this maximizes the number of stimulation contacts and increases the contact area between the electrode and the nucleus, the lack of angle adjustment means that some contacts may be exposed outside the target area after implantation. This makes it difficult to localize the stimulation current within the target nucleus, potentially exposing non-target tissue to unwanted stimulation, leading to side effects or adverse reactions. The accuracy and stability of electrode implantation remain challenges. Despite precise implantation using stereotactic techniques, individual anatomical variations and subtle intraoperative deviations can cause electrode position shift, compromising targeted stimulation. Furthermore, after implantation, physiological movement or morphological changes in brain tissue (such as brain atrophy) can cause electrode position to shift over time, impacting long-term efficacy. For patients requiring long-term, continuous stimulation, electrode position shift may lead to decreased efficacy, and reimplantation surgery increases surgical risk and patient burden.

[0038] For patients with mid- to late-stage Parkinson's disease, the lateral subthalamic nucleus is usually selected as the optimal stimulation target. However, as treatment progresses and the disease progresses, pathological activity within the neural network may migrate, causing the initially set stimulation target to no longer be applicable. The stimulation position of the currently used electrodes can only be adjusted along the long axis of the electrode, such as by selecting the stimulation point through directional electrical stimulation. However, due to the long strip-like anatomical structure of the subthalamic nucleus and the limited implantation angle, it is impossible to effectively adjust the stimulation of other areas within the nucleus. This greatly limits the flexibility and effectiveness of long-term treatment.

[0039] In this regard, the present application proposes a flexible stimulation electrode for magnetically guided implantation. The magnetic field generated by the magnetic control system can apply magnetic force to the electrode wire body that has been inserted into the patient's body, thereby fine-tuning the position of the electrode wire body; through multiple stimulation contacts set on the electrode wire body, different areas of the patient can be electrically stimulated, and the output current is recorded through the signal recording contacts, thereby closed-loop controlling the stimulation intensity of the stimulation contacts to achieve precise stimulation.

[0040] Reference Figure 1 The flexible stimulation electrode for magnetically guided implantation in the embodiment of the first aspect of the present application includes an electrode wire body 100, a stimulation contact 200, a signal recording contact 300, a conductive wire 400, a guiding magnet 500, and a magnetic control system 600 (refer to Figure 3 ) and a guide wire 700. Among them, the electrode wire body 100 is the main structure of the flexible stimulation electrode for magnetic control guided implantation. The stimulation contact 200 and the signal recording contact 300 are both arranged on the electrode wire body 100, and both are connected to external electronic equipment through the conductive wire 400. The stimulation contact 200 is used to output current to electrically stimulate the patient, and the signal recording contact 300 is used to detect the output current of the stimulation contact 200 to perform closed-loop control of the output power. The guide magnet 500 is installed in the electrode wire body 100. The magnetic field generated by the magnetic control system 600 can generate a magnetic force on the guide magnet 500, and then act on the electrode wire body 100 to fine-tune its position in the patient's body, thereby achieving the effect of precise stimulation.

[0041] Specifically, the end of the electrode wire body 100 is provided with a tapered electrode tip 110, which is used to reduce resistance during insertion into the patient's body, making it easier for the electrode wire body 100 to be inserted into the patient's body. The electrode wire body 100 has a cavity inside, which is used to accommodate components such as the stimulation contacts 200, signal recording contacts 300, and the guide magnet 500. One end of the cavity is open, allowing the conductive wire 400 to extend from the electrode wire body 100.

[0042] There are multiple stimulation contacts 200 , and they are all equidistantly arranged along the length direction of the electrode wire body 100 . Different stimulation contacts 200 can be selected for stimulation, thereby electrically stimulating areas at different depths.

[0043] There are multiple signal recording contacts 300, and they are all equidistantly arranged along the length direction of the electrode wire body 100. Different signal recording contacts 300 can be selected to detect the output current at different positions. Generally, the stimulation area of the stimulation contact 200 is detected, so as to perform closed-loop control on the output power of the stimulation contact 200.

[0044] The conductive wire 400 is electrically connected to each stimulation contact 200 and the signal recording contact 300, and is connected to an external electronic device. This allows the external electronic device to output current to the stimulation contacts 200 through the conductive wire 400 to complete the electrical stimulation process. The external electronic device can also obtain detection data from the signal recording contacts 300 through the conductive wire 400 and perform closed-loop control of the output power.

[0045] The guide magnet 500 is installed in the cavity of the wire body 100. The magnetron system 600 is located outside the wire body 100 and is used to generate a magnetic field. The guide magnet 500 is affected by the magnetic field generated by the magnetron system 600. The magnetic field force acts on the wire body 100 through the guide magnet 500 to fine-tune the position of the wire body 100.

[0046] Furthermore, the guide magnet 500 is located at the position of the electrode tip 110, so that the electrode tip 110 moves mainly under the influence of magnetic force. During the insertion process of the electrode wire body 100, the insertion position and insertion direction of the electrode wire body 100 can be more accurately adjusted by affecting the position of the electrode tip 110.

[0047] Furthermore, the magnetically guided implanted flexible stimulation electrode also includes a guide wire 700, one end of which is connected to the guiding magnet 500, and the other end of which extends from the cavity of the electrode wire body 100. The guide wire 700 is used to be pulled by medical personnel to manually adjust the position of the electrode wire body 100. Through the dual control of the guide wire 700 and the guiding magnet 500, more subtle adjustments can be made to the electrode wire body 100.

[0048] Furthermore, the guide wire 700 is detachably connected to the guide magnet 500 , and the guide wire 700 can be pulled out from the electrode wire body 100 , so that after the guide wire 700 is pulled out, the electrode wire body 100 can be subcutaneously fixed in the patient's body.

[0049] Further, refer to Figure 2 There are multiple conductive wires 400, which are electrically connected to the stimulation contacts 200 and the signal recording contacts 300 respectively. The conductive wires 400 are insulated from each other to avoid current interference between different contacts.

[0050] Furthermore, at least two groups of stimulation contacts 200 are provided, each group of stimulation contacts 200 being arranged in a circular array around the central axis of the electrode wire body 100, so that different groups of stimulation contacts 200 can electrically stimulate areas in different directions. The signal recording contacts 300 are located between each group of stimulation contacts 200.

[0051] Furthermore, in this embodiment, the number of the signal recording contacts 300 and the number of each group of stimulation contacts 200 are both four.

[0052] Furthermore, the electrode wire body 100 is a flexible member, which can reduce the discomfort caused to the patient after the electrode wire body 100 is inserted, and the flexible electrode wire body 100 can adapt to the curved insertion channel in the human body.

[0053] Furthermore, the electrode wire body 100 is cylindrical, and the electrode tip 110 is conical, which can reduce the sharp corners on the surface of the electrode wire body 100, thereby preventing the sharp corners from scratching the internal tissues of the human body.

[0054] The following describes the implantation method of the flexible stimulation electrode based on the magnetic control guided implantation:

[0055] Reference Figure 4 Preoperative CT, MRI, and CTA vascular imaging are performed under stereotactic control. CT images clearly capture the bony structure of the brain, while MRI images clearly display deep brain nuclei and can be used for nucleus segmentation. The combined use of CT and MRI can effectively obtain and reconstruct the location of nuclei. Furthermore, three-dimensional cerebral vascular reconstruction using CTA can obtain information on the distribution of brain blood vessels.

[0056] The spatial location of the nucleus will be accurately registered with the vascular information to establish a surgical coordinate system. Furthermore, an electrode implantation path that avoids blood vessels will be planned and formulated.

[0057] During the operation, under the fixation of the stereotactic frame, the magnetic control system 600 performs real-time spatial registration with the entire brain to match the coordinate system planned before the operation. The magnetic control system 600 controls the guide magnet 500 through an external magnetic field to guide the electrode to move along a predetermined trajectory. Synchronously, the computer system generates a three-dimensional visualization diagram in real time to intuitively display the implantation process. During the electrode implantation process, the magnetic control system 600 dynamically adjusts the magnetic field to compensate for the pulling effect of the electrode wire body 100 or the electrode tip 110 on the tissue, as well as the tissue displacement and vibration caused by the pulse fluctuation of the intracranial blood vessels, thereby correcting the trajectory error in real time. After the implantation process is completed, the magnetic control equipment is turned off, the MRI imaging system is started, and a final inspection of the electrode implantation site is performed.

[0058] Reference Figure 3 Under the guidance of the magnetic control system 600, the electrode tip 110 enters along the long axis (i.e., dorsolateral direction) of the subthalamic nucleus (as shown by the arrow) and is evenly distributed within the nucleus. The electrode wire body 100 is fixed by the cranial hole electrode lock at the cranial hole, and the conductive wire 400 is connected to the pulse generator or electrical signal recording equipment. After the implantation operation and imaging examination are completed, the guide wire 700 is slowly withdrawn, and the subcutaneous fixation of the electrode wire body 100 and the placement of the pulse generator are completed.

[0059] The embodiments of the present application have been described in detail above with reference to the accompanying drawings. However, the present application is not limited to the above embodiments. Various modifications can be made within the scope of knowledge possessed by ordinary technicians in the relevant technical field without departing from the purpose of the present application. In addition, the embodiments of the present application and the features of the embodiments can be combined with each other unless there is a conflict.

Claims

1. A flexible stimulation electrode implanted under magnetic guidance, characterized in that: include: An electrode wire body, the end of which is provided with a conical electrode tip, and the interior of the electrode wire body is provided with a cavity; There are multiple stimulation contacts, which are equidistantly arranged along the length of the electrode wire body; There are multiple signal recording contacts, which are equidistantly arranged along the length of the electrode wire body; a conductive wire electrically connected to each of the stimulation contacts and the signal recording contacts, wherein the conductive wire is connected to an external electronic device; a guide magnet installed in the cavity of the electrode wire body; a magnetic control system, which is arranged outside the electrode wire body and is used to generate a magnetic field; The guiding magnet is affected by the magnetic field generated by the magnetron system, and the magnetic field force acts on the electrode wire body through the guiding magnet to fine-tune the position of the electrode wire body.

2. The flexible stimulation electrode for magnetically guided implantation according to claim 1, characterized in that: The guide magnet is located at the tip of the electrode.

3. The flexible stimulation electrode for magnetically guided implantation according to claim 1, characterized in that: The magnetically guided implanted flexible stimulation electrode also includes a guide wire, one end of which is connected to the guiding magnet, and the other end of the guide wire extends from the cavity of the electrode wire body. The guide wire is used to be pulled by medical staff to manually adjust the position of the electrode wire body.

4. The flexible stimulation electrode for magnetically guided implantation according to claim 3, characterized in that: The guide wire is detachably connected to the guide magnet, and the guide wire can be pulled out from the electrode wire body.

5. The flexible stimulation electrode for magnetically guided implantation according to claim 1, characterized in that: There are multiple conductive threads, which are electrically connected to the stimulation contacts and the signal recording contacts in a one-to-one correspondence.

6. The flexible stimulation electrode for magnetically guided implantation according to claim 1, characterized in that: The stimulation contacts are provided in at least two groups, and the stimulation contacts in each group are distributed in a circular array around the central axis of the electrode wire body.

7. The flexible stimulation electrode for magnetically guided implantation according to claim 6, characterized in that: The signal recording contacts are located between each group of stimulation contacts.

8. The flexible stimulation electrode for magnetically guided implantation according to claim 6, characterized in that: The number of the signal recording contacts and the number of the stimulation contacts in each group are both 4.

9. The flexible stimulation electrode for magnetically guided implantation according to claim 1, characterized in that: The electrode wire body is a flexible part.

10. The flexible stimulation electrode for magnetically guided implantation according to claim 1, characterized in that: The electrode wire body is cylindrical, and the electrode tip is conical.

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