Magnetic control flexible electrode system

Abstract

The invention belongs to the technical field of medical instruments, and particularly discloses a magnetic control flexible electrode system which comprises a magnetic control flexible electrode unit, a signal acquisition unit and an external magnetic control unit. Each magnetic control flexible electrode unit comprises an insulating flexible stretchable magnetic substrate layer, a uniformly stretchable conductive layer and a stretchable insulating packaging layer which are arranged in sequence; an external magnetic field is applied to the magnetic control flexible electrode unit through the external magnetic control unit, so that the magnetic control flexible electrode unit is controlled to unfold, contract and rotate, and the position and form of the magnetic control flexible electrode unit are adjusted; the electrophysiological signals are collected through the signal collecting unit. The magnetic control flexible electrode system provided by the invention overcomes the defects of large trauma, poor adaptability, low signal quality and precision, complex operation and the like in the prior art.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of medical devices, and relates to a magnetic control flexible electrode system. BACKGROUND

[0002] Arrhythmia (such as ventricular tachycardia, atrial fibrillation) is a cardiovascular disease affecting a large number of patients worldwide, and accurate electrophysiological mapping is crucial for diagnosis and treatment. Current mapping methods mainly focus on endocardial catheter ablation. However, recent studies have shown that some complex arrhythmias (such as Brugada syndrome, idiopathic ventricular tachycardia, etc.) are closely related to epicardial electrical activity, so accurate monitoring of the epicardium becomes particularly important.

[0003] The existing cardiac electrophysiological mapping system has limitations in epicardial mapping and treating arrhythmia:

[0004] In terms of trauma, most of the existing technology relies on pericardiocentesis or open chest surgery for epicardial mapping, which not only causes great trauma to the patient, but also has a high risk of complications such as infection and bleeding;

[0005] In terms of adaptability, the rigid catheter or electrode array in the existing technology cannot flexibly adapt to the complex geometry of the heart surface, and can usually only cover part of the heart area, especially the epicardial electrophysiological signal acquisition capability is poor;

[0006] In terms of signal accuracy and acquisition capability, the electrode array of the existing technology usually cannot provide sufficient electrical signal density and resolution, thereby limiting the accuracy of the electrophysiological data;

[0007] In terms of operational convenience, traditional mapping systems usually rely on the coordinated work of multiple catheters, the operation process is cumbersome, and the angle and position of the equipment need to be adjusted multiple times, which not only increases the operation time, but also increases the difficulty of operation. SUMMARY

[0008] Therefore, the present application provides a magnetic control flexible electrode system, which overcomes the shortcomings of large trauma, poor adaptability, low signal quality and accuracy, and complex operation in the prior art.

[0009] To solve the above problems, the embodiment of the present application provides a magnetic control flexible electrode system, which is characterized in that:

[0010] The magnetic control flexible electrode system comprises a magnetic control flexible electrode unit, a signal acquisition unit and an external magnetic control unit.

[0011] The magnetic control flexible electrode unit comprises an insulating flexible stretchable magnetic substrate layer, a uniformly stretchable conductive layer and a stretchable insulating packaging layer arranged in sequence.

[0012] An external magnetic control unit is used to apply an external magnetic field to the magnetic control flexible electrode unit, so as to control the magnetic control flexible electrode unit to expand, shrink and rotate, and adjust the position and shape of the magnetic control flexible electrode unit; and an electrical physiological signal on the surface of the heart is collected by a signal collection unit.

[0013] Further, the insulating flexible stretchable magnetic substrate layer is made by mixing magnetic particles and elastomer materials.

[0014] Further, the magnetic particles and the elastomer materials are mixed uniformly and then spin-coated and solidified to form a thin film.

[0015] Further, the thickness of the thin film can be between 200-300um, and the width and length can be made or cut as needed, specifically according to the scene requirements, and the thin film has excellent flexibility and stretchability.

[0016] Further, the magnetic particles are NdFeB (neodymium iron boron), Fe3O4 and the like, and the elastomer material is an ecoflex 00-20 elastomer material.

[0017] Further, the insulating flexible stretchable magnetic substrate layer is magnetized to form an N, S magnetic pole arrangement arranged at intervals.

[0018] Further, the isotropically stretchable conductive layer comprises a plurality of electrodes, and the electrodes are stretchable conductive gold films, which ensure isotropic stretchable conductivity.

[0019] Further, the electrodes are vacuum evaporated on the insulating flexible stretchable magnetic substrate layer to obtain the isotropically stretchable conductive layer.

[0020] Further, the stretchable insulating packaging layer is made of an ecoflex 00-20 material or the like to package the electrodes.

[0021] Further, the electrodes in the isotropically stretchable conductive layer are connected to the signal collection unit through a flexible printed circuit board.

[0022] Compared with the prior art, the magnetic control flexible electrode system has at least the following beneficial effects:

[0023] In terms of trauma, the robot provided by the application introduces the device into the body through minimally invasive surgery, greatly reduces the trauma to the patient, and through external magnetic field control, the robot can be expanded from a cylindrical shape into a thin film, fully adapting to the complex three-dimensional structure of the surface of the heart, thus avoiding the large-area incision surgery in the traditional technology.

[0024] In terms of adaptability, the robot provided by this invention adopts a flexible electrode film design, which can flatten into an ultra-thin film under the action of a magnetic field, closely fit the surface of the heart, and cover more electrophysiological signal acquisition areas. The flexible design enables it to provide uniform electrode contact on the complex curved surface of the heart, significantly improving the integrity and quality of signal acquisition.

[0025] In terms of signal accuracy and acquisition capability, the robot provided by this invention is equipped with a high-density electrode array, which can simultaneously acquire electrophysiological signals from multiple points. Due to its flexible structure, it can provide higher acquisition density and signal resolution. Through a real-time transmission and data processing system, the robot can provide more accurate and real-time electrophysiological data, providing doctors with more comprehensive and effective diagnostic support.

[0026] In terms of ease of operation, the robot provided by this invention achieves automatic deployment and retraction through an external magnetic field control system, reducing operational complexity. Doctors only need to control the direction and intensity of the external magnetic field to precisely adjust the robot's position and shape, thereby greatly simplifying the surgical procedure and improving operational efficiency.

[0027] The above description is merely an overview of the technical solution of the present invention. In order to better understand the technical means of the present invention and to implement it in accordance with the contents of the specification, the preferred embodiments of the present invention are described in detail below with reference to the accompanying drawings. Attached Figure Description

[0028] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the following description of the embodiments will be briefly introduced. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0029] Figure 1 This is an exploded view of the magnetically controlled flexible electrode unit proposed in this invention;

[0030] Figure 2 This is a magnetic field distribution diagram of the insulating flexible stretchable magnetic substrate layer proposed in this invention;

[0031] Figure 3 This is a diagram showing the use of the magnetically controlled flexible electrode system proposed in this invention for epicardial mapping.

[0032] Figure 4 This is a schematic diagram of the motion mode of the magnetically controlled flexible electrode system proposed in this invention;

[0033] Figure 5 This is a schematic diagram illustrating the application of the magnetically controlled flexible electrode system proposed in this invention for epicardial mapping.

[0034] In the figure: 1. Magnetically controlled flexible electrode unit; 11. Insulating flexible stretchable magnetic substrate layer; 12. Unidirectionally stretchable conductive layer; 13. Stretchable insulating encapsulation layer. Detailed Implementation

[0035] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0036] Embodiments of the present invention provide a magnetically controlled flexible electrode system, including a magnetically controlled flexible electrode unit 1, a signal acquisition unit, and an external magnetic control unit. An external magnetic field is applied to the magnetically controlled flexible electrode unit by the external magnetic control unit, thereby controlling the expansion, contraction, and rotation of the magnetically controlled flexible electrode unit and adjusting its position and shape; the signal acquisition unit acquires electrophysiological signals from the surface of the heart.

[0037] See Figure 1 The magnetically controlled flexible electrode unit 1 includes, from bottom to top, an insulating flexible stretchable magnetic substrate layer 11, a uniformly stretchable conductive layer 12, and a stretchable insulating encapsulation layer 13.

[0038] Specifically, the insulating flexible stretchable magnetic substrate layer is made by mixing magnetic particles and elastomer materials. After the magnetic particles and elastomer materials are mixed evenly, they are spin-coated and cured to form a thin film.

[0039] The film thickness can be between 200-300 μm. The width and length can be manufactured or cut as needed, depending on the specific requirements of the application scenario, and it has excellent flexibility and stretchability.

[0040] Specifically, the magnetic particles are materials such as NdFeB (neodymium iron boron) and Fe3O4, and the elastomer material is ecoflex 00-20 elastic material.

[0041] Specifically, see Figure 2 The insulating, flexible, and stretchable magnetic substrate layer, after being magnetized, forms an N and S magnetic pole arrangement with intervals. Based on this specific magnetic field distribution, it can unfold or curl under extremely low frequencies of 0.1 Hz and extremely weak magnetic fields of 5 mT. The cylindrical robot moves and rotates under the influence of magnetic torque and gradient magnetic field forces. Furthermore, when driven in the opposite direction, it can unfold from a one-dimensional cylinder into a two-dimensional thin film. When used for epicardial mapping, it can stably adhere to the epicardium and connect to a backend signal acquisition device to achieve high-density, high-precision electrical signal acquisition.

[0042] Specifically, the uniformly stretchable conductive layer comprises multiple electrodes. A mask for fabricating the electrode pattern is designed to contain at least 4 electrodes / cm.2 A stretchable conductive material, such as gold or silver, is deposited (by vapor deposition or magnetron sputtering) on ​​an insulating, flexible, and stretchable magnetic substrate to ensure homogeneous stretchable conductivity, thus obtaining a homogeneous stretchable conductive layer.

[0043] Specifically, the stretchable insulating encapsulation layer uses ecoflex 00-20 material to encapsulate the electrodes.

[0044] Specifically, the electrodes in the uniformly stretchable conductive layer are connected to the signal acquisition unit via a flexible printed circuit board.

[0045] This invention proposes a magnetically controlled flexible electrode system. This system uses an external magnetically controlled unit to provide a magnetic field, controlling the flexible electrode unit to deform into a cylindrical shape for guidance and removal. It can also unfold into a thin film within the body to adapt to the complex three-dimensional morphology of the heart, enabling efficient electrophysiological data acquisition and real-time monitoring, thereby improving the accuracy of arrhythmia diagnosis and treatment. Different magnetically controlled layer materials or electrode array arrangements can be used in the magnetically controlled flexible electrode unit 1 to optimize its fit for different patients.

[0046] See Figures 3-4 After unfolding, the magnetically controlled flexible electrode unit's electrode array can closely conform to the uneven tissue surface, allowing for high-density, synchronous acquisition of electrophysiological signals from the heart's surface via a rear-end signal acquisition device. After signal acquisition, the unit is reversibly rolled back to its initial state by external magnetic field manipulation, utilizing the magnetic dipole moment. This facilitates removal from the body or re-unfolding and re-rolling to a different detection location.

[0047] The working principle and operation procedure of this magnetically controlled flexible electrode system for epicardial mapping are as follows:

[0048] 1) Preoperative preparation: The magnetically controlled flexible electrode unit is rolled into a cylindrical shape and inserted into the patient's body through a minimally invasive surgery, usually through a small incision into the pericardial cavity.

[0049] 2) Deployment process: The external magnetocontrol unit adjusts parameters such as the direction and intensity of the magnetic field to transform the magnetocontrollable flexible electrode unit from a cylindrical shape to a thin film shape, ensuring a close fit to the heart surface for efficient acquisition of electrophysiological signals. The deployed thin film has sufficient flexibility and elasticity to adapt to the complex geometry of the heart surface.

[0050] 3) Electrophysiological mapping: After deployment, the magnetically controlled flexible electrode unit acquires electrophysiological signals through its built-in electrode array, covering the epicardium region. The acquired electrical signals are transmitted in real time to external devices for monitoring and analysis via a back-end interface.

[0051] 4) Relocation and Removal Process: After completing the mapping at position 1, if a change of detection position is required, the robot can be rolled back into a cylindrical shape using a magnetic field provided by an external magnetic control unit, then moved to the new monitoring point and re-deployed for detection, repeating steps 2) and 3). After completing the mapping, the magnetic field is adjusted using the external magnetic control unit to roll the magnetically controlled flexible electrode unit back into a cylindrical shape, and it is removed through a minimally invasive incision to ensure minimal trauma. Figure 5 As shown.

[0052] In summary, the magnetically controlled flexible electrode system provided by this invention significantly outperforms existing cardiac electrophysiological mapping technologies in terms of reduced trauma, improved adaptability, enhanced signal acquisition accuracy, and simplified operation, offering an innovative and efficient solution for cardiac electrophysiological monitoring and treatment. This magnetically controlled flexible electrode system can also be used for acquiring other bioelectrical signals, such as cerebral cortex electrode monitoring, electromyography (EMG) signal acquisition, and gastrointestinal electrophysiology, thereby expanding its clinical applications.

[0053] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention in any way. Any simple modifications, equivalent changes and alterations made to the above embodiments based on the technical essence of the present invention shall still fall within the scope of the technical solution of the present invention.

Claims

1. A magnetically controlled flexible electrode system, characterized in that: It includes a magnetically controlled flexible electrode unit (1), a signal acquisition unit, and an external magnetic control unit; The magnetically controlled flexible electrode unit (1) includes an insulating flexible stretchable magnetic substrate layer (11), a uniformly stretchable conductive layer (12), and a stretchable insulating encapsulation layer (13) arranged sequentially. An external magnetic field is applied to the magnetically controlled flexible electrode unit (1) by an external magnetic control unit, thereby controlling the magnetically controlled flexible electrode unit (1) to unfold, contract and rotate, and adjusting the position and shape of the magnetically controlled flexible electrode unit (1); electrophysiological signals are collected by a signal acquisition unit.

2. The magnetically controlled flexible electrode system according to claim 1, characterized in that: The insulating flexible stretchable magnetic substrate layer (11) is made of a mixture of magnetic particles and elastomer materials.

3. The magnetically controlled flexible electrode system according to claim 2, characterized in that: The magnetic particles and elastomer material are mixed evenly and then spin-coated and cured to form a thin film.

4. The magnetically controlled flexible electrode system according to claim 3, characterized in that: The thickness of the film can be between 200-300 μm.

5. The magnetically controlled flexible electrode system according to claim 4, characterized in that: The magnetic particles are NdFeB or Fe3O4 materials, and the elastomer material is ecoflex 00-20 material.

6. The magnetically controlled flexible electrode system according to claim 5, characterized in that: After the insulating flexible stretchable magnetic substrate layer (11) is magnetized, it forms an N and S magnetic pole arrangement with intervals.

7. The magnetically controlled flexible electrode system according to any one of claims 1-6, characterized in that: The uniformly stretchable conductive layer (12) includes multiple electrodes, which are made of stretchable conductive material.

8. The magnetically controlled flexible electrode system according to claim 7, characterized in that: The electrode is vacuum-deposited at high temperature onto an insulating, flexible, stretchable magnetic substrate (11) to obtain a uniformly stretchable conductive layer (12).

9. The magnetically controlled flexible electrode system according to claim 8, characterized in that: The stretchable insulating encapsulation layer (13) encapsulates the electrodes using ecoflex material.

10. The magnetically controlled flexible electrode system according to claim 9, characterized in that: The electrodes in the uniformly stretchable conductive layer (12) are connected to the signal acquisition unit via a flexible printed circuit board.

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