A spin-out multi-electrode leadless pacemaker for left bundle branch region pacing
By leveraging the synergistic effect of the spiral rod and microelectrode bundle in the screw-out multi-electrode leadless pacemaker, the problems of unreliable fixation in the left bundle branch region and unadjustable pacing site in existing leadless pacemakers are solved. This achieves precise physiological pacing and stable anchoring, reduces the risk of dislocation, and improves the long-term reliability and operational flexibility of the device.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- THE SECOND XIANGYA HOSPITAL OF CENT SOUTH UNIV
- Filing Date
- 2025-12-15
- Publication Date
- 2026-07-07
AI Technical Summary
Existing leadless pacemakers have a single fixation method in the left bundle branch region, which makes it difficult to achieve reliable physiological pacing, poses a risk of dislocation, and the pacing site is not adjustable, resulting in poor fault tolerance.
It adopts a spiral-out multi-electrode structure, including a spiral rod and a bundle of microelectrodes. Multi-point anchoring is achieved through a drive mechanism. Combined with electrical testing and algorithm optimization, the optimal pacing electrode site is selected to form a three-dimensional anchoring network, providing multi-directional resistance to torsion and shear forces.
It achieves precise and reliable physiological pacing in the left bundle branch region, reduces the risk of dislocation, improves the long-term lifespan and reliability of the device, reduces surgical risks, and enables in vivo optimization of electrode sites, thereby enhancing operational flexibility and safety.
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Figure CN121371469B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of medical device technology, and in particular to a rotating multi-electrode leadless pacemaker for pacing the left bundle branch region. Background Technology
[0002] A pacemaker is a core device for treating arrhythmias such as bradycardia and heart block. Traditional pacing systems consist of a pulse generator in a subcutaneous pocket and an electrode lead implanted via a vein, but they carry long-term risks such as lead breakage, insulation damage, venous thrombosis, and pocket infection.
[0003] To overcome the aforementioned drawbacks, leadless pacemakers have emerged, such as Medtronic's Micra™ series (see patent document US20150374605A1) and Abbott's Aveir™ series. These products are delivered via catheter and implanted directly into the apex of the right ventricle or the interventricular septum. Their fixation methods are mainly divided into two categories: one is passive fixation using retractable nickel-titanium alloy "claws"; the other is active fixation using a single spiral electrode that can be screwed into the myocardium.
[0004] However, existing leadless pacemakers have the following inherent drawbacks due to structural limitations:
[0005] 1. Inability to achieve reliable His-Purkinje system physiological pacing: Existing products use an integrated design for both fixation and pacing (i.e., the fixation point is also the pacing point). Due to the deep anatomical location of the left bundle branch and significant individual variability, a single helical or claw electrode cannot accurately locate the left bundle branch region during initial implantation. Even if it is accidentally located close, site optimization is not possible, resulting in an inability to stably capture the left bundle branch and achieve true physiological pacing.
[0006] 2. Limited fixation methods and risk of dislocation: Whether it's "claw" fixation or simple spiral fixation, the contact points with the myocardium are limited. Under continuous and intense cardiac contractions, especially when located high in the interventricular septum, the torque provided by existing fixation methods is insufficient, posing a certain risk of mid-term dislocation.
[0007] 3. The pacing site is not adjustable, resulting in poor fault tolerance: Current leadless pacemakers have only one pacing electrode contact. After implantation, if problems such as increased pacing threshold, poor sensing, or diaphragmatic irritation occur at this site, the operator cannot adjust it within the body. It can only be removed and reimplanted through a complex and high-risk surgery.
[0008] The root cause of the above problems is that the anchoring structure of existing leadless pacemakers is singular and rigid, and does not have the ability to be dynamically adjusted and optimized within the target area.
[0009] Therefore, a rotating multi-electrode leadless pacemaker for pacing the left bundle branch region is proposed. Summary of the Invention
[0010] The purpose of this invention is to provide a rotating multi-electrode leadless pacemaker for pacing the left bundle branch region, aiming to solve at least the following problems of existing leadless pacemakers: (1) single fixation method and insufficient anti-dislocation ability; (2) fixed and unadjustable pacing site, making it impossible to achieve post-implantation optimization; (3) difficult to reliably achieve physiological pacing in the left bundle branch region.
[0011] To achieve the above objectives, the present invention provides the following solution: The present invention provides a rotating multi-electrode leadless pacemaker for left bundle branch region pacing, comprising:
[0012] The capsule shell contains an energy storage control system and a first drive mechanism.
[0013] A spiral rod, one end of which is connected to the output end of the first drive mechanism, and the other end of which slides out to the outside of the capsule shell; the spiral rod is hollow inside, and a plurality of guide channels are circumferentially opened on the outer wall of the side of the spiral rod away from the capsule shell, and the plurality of guide channels are arranged in a radiating manner;
[0014] A microelectrode bundle, comprising a plurality of microelectrodes, one side of which is fixedly connected and the other side of which extends into a plurality of guide channels; the microelectrodes are covered with an insulating layer, and the end of the microelectrode near the guide channel exposes the insulating layer;
[0015] The second drive mechanism is installed in the inner cavity of the screw rod, and the output end of the second drive mechanism is fixedly connected to the end of the micro electrode away from the guide channel.
[0016] Among them, several of the microelectrodes, the first driving mechanism and the second driving mechanism are all electrically connected to the energy storage control system.
[0017] According to the present invention, a screw-out multi-electrode leadless pacemaker for pacing in the left bundle branch region is provided. The energy storage control system includes a battery, a controller, and a wireless communication module. The battery, the wireless communication module, a plurality of microelectrodes, the first drive mechanism, and the second drive mechanism are all electrically connected to the controller.
[0018] The controller is used to control the second drive mechanism to push out the microelectrode, and then use the selected microelectrode as the pacing cathode to perform pacing threshold and electrode impedance tests, record the test data of each microelectrode, and select one or more optimal pacing electrode sites based on the test data according to a preset algorithm; the optimal pacing electrode sites are determined according to the position of the microelectrode.
[0019] According to the present invention, a screw-out multi-electrode leadless pacemaker for pacing in the left bundle branch region is provided, wherein the outer wall of the screw rod is provided with external threads.
[0020] According to the present invention, a screw-out multi-electrode leadless pacemaker for pacing the left bundle branch region is provided, wherein the microelectrode is made of a superelastic nickel-titanium alloy wire, and the end of the microelectrode near the guide channel is set in an arc shape or hook shape.
[0021] According to the present invention, a screw-out multi-electrode leadless pacemaker for pacing the left bundle branch region has a plurality of guide channels whose axes are distributed in a three-dimensional scattering manner, so that the protruding microelectrodes can be anchored in myocardial tissue at different depths to form a three-dimensional anchoring structure.
[0022] According to the present invention, a rotating multi-electrode leadless pacemaker for pacing the left bundle branch region is provided, wherein the insulating layer is a poly(p-xylene) biocompatible insulating layer.
[0023] According to the present invention, a screw-out multi-electrode leadless pacemaker for pacing the left bundle branch region is provided, wherein the end of the microelectrode protrudes 1 mm to 2 mm from the insulating layer.
[0024] According to the present invention, a screw-out multi-electrode leadless pacemaker for pacing the left bundle branch region is provided. The first drive mechanism includes a first micro motor and a first push rod. The first micro motor is installed inside the capsule shell and is electrically connected to the controller. The first micro motor is used to drive the first push rod to translate. The end of the first push rod away from the first micro motor is fixedly connected to the helical rod.
[0025] According to the present invention, a screw-out multi-electrode leadless pacemaker for pacing in the left bundle branch region includes a second drive mechanism comprising a second micro motor and a second push rod. The second micro motor is mounted inside the screw rod and is electrically connected to the controller. The second micro motor is used to drive the second push rod to translate. One end of the second push rod away from the second micro motor is fixedly connected to a plurality of the microelectrodes.
[0026] According to the present invention, a rotating multi-electrode leadless pacemaker for pacing the left bundle branch region is provided, wherein the number of microelectrodes is six.
[0027] According to the present invention, a screw-out multi-electrode leadless pacemaker for pacing the left bundle branch region is provided, wherein a plurality of microelectrodes are fitted with positioning rings, and the positioning rings are slidably connected to the inner wall of the spiral rod.
[0028] The present invention discloses the following technical effects:
[0029] This invention systematically solves the problem of stable pacing of the left bundle branch region in complex anatomical structures through the initial positioning of the helical rod and the synergistic effect of the micro-electrode bundle. It can reliably obtain the narrowest pacing QRS wave, maximize hemodynamic benefits, and achieve precise and reliable physiological pacing.
[0030] This invention provides axial tensile force through a helical rod, and several microelectrodes extend through guide channels in a radiating arrangement to provide three-dimensional anchoring points, forming a mace-like mechanical structure. It can achieve precise positioning of the left bundle branch region through a spiral-out multi-electrode array, counteracting stresses from heartbeats in all directions. The helical rod provides the main axial tensile force, and the three-dimensional anchoring network formed by the microelectrode bundle provides multi-directional torsional and shear resistance. Its fixation efficiency far exceeds that of a single helical or claw fixation, and theoretically, its dislocation risk can be reduced by an order of magnitude compared to traditional leadless pacemakers.
[0031] This invention utilizes several microelectrodes for in vivo electrical testing and optimization, avoiding functional failure caused by damage to a single electrode. It ensures that when the performance of a certain electrode site deteriorates during long-term use, it can switch to other microelectrodes, eliminating the need for repeated removal and reimplantation of the pacemaker due to the poor performance of a single electrode site. After implantation, it can select the electrode site with the best electrical characteristics for long-term pacing, achieving precise positioning, stable anchoring, and intelligent electrode site selection. This reduces surgical risks and effectively improves the long-term lifespan and reliability of the device. Attached Figure Description
[0032] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.
[0033] Figure 1 This is the front view of the present invention;
[0034] Figure 2 This is a schematic diagram of the internal structure of the present invention;
[0035] Figure 3 This is a schematic diagram of the internal structure of the screw rod in this invention;
[0036] Figure 4 This is a schematic diagram of the protruding microelectrodes in this invention;
[0037] Figure 5 This is a schematic diagram of the layout of the guide channels in this invention.
[0038] The components include: 1. Capsule shell; 2. First drive mechanism; 3. Spiral rod; 4. Guide channel; 5. Microelectrode; 6. Second drive mechanism; 7. Battery; 8. Controller; 9. Wireless communication module; and 10. Positioning ring. Detailed Implementation
[0039] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.
[0040] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.
[0041] Reference Figures 1-5 This invention provides a rotating multi-electrode leadless pacemaker for left bundle branch pacing, comprising:
[0042] Capsule shell 1, and an energy storage control system and a first drive mechanism 2 are installed inside the capsule shell 1;
[0043] The spiral rod 3 has one end connected to the output end of the first drive mechanism 2 and the other end sliding out to the outside of the capsule shell 1. The spiral rod 3 is hollow inside, and a number of guide channels 4 are circumferentially opened on the outer wall of the spiral rod 3 on the side away from the capsule shell 1. The number of guide channels 4 are arranged in a radiating manner.
[0044] The microelectrode bundle includes several microelectrodes 5, one side of which is fixedly connected and the other side extends into several guide channels 4; the microelectrodes 5 are covered with an insulating layer, and the end of the microelectrodes 5 near the guide channels 4 exposes the insulating layer.
[0045] The second drive mechanism 6 is installed in the inner cavity of the screw rod 3, and the output end of the second drive mechanism 6 is fixedly connected to the end of the micro electrode 5 away from the guide channel 4.
[0046] Among them, several microelectrodes 5, the first driving mechanism 2 and the second driving mechanism 6 are all electrically connected to the energy storage control system;
[0047] With this configuration, the present invention systematically solves the problem of stabilizing left bundle branch pacing in complex anatomical structures through the initial positioning of the helical rod 3 and the synergistic effect of the micro-electrode bundle. It can reliably obtain the narrowest pacing QRS wave, maximize hemodynamic benefits, and achieve precise and reliable physiological pacing.
[0048] This invention provides axial tensile force through a helical rod 3, and several microelectrodes 5 extend through guide channels 4 in a scattering arrangement to provide three-dimensionally distributed anchoring points, forming a mace-like mechanical structure. It can achieve precise positioning of the left bundle branch region through a spiral-type multi-electrode array, counteracting stresses in all directions caused by heartbeats. The helical rod 3 provides the main axial tensile force, and the three-dimensional anchoring network formed by the microelectrode bundle provides multi-directional anti-torsion and anti-shear forces. Its fixation efficiency far exceeds that of a single helical or claw fixation. Theoretically, its dislocation risk can be reduced by an order of magnitude compared to traditional leadless pacemakers.
[0049] This invention uses several microelectrodes 5 to perform electrical testing and optimization in vivo, avoiding functional failure caused by damage to a single electrode. It ensures that when the performance of a certain electrode site deteriorates during long-term use, it can switch to other microelectrodes 5. This eliminates the need for repeated removal and reimplantation of the pacemaker due to the poor performance of a single electrode site. After implantation, it can select the electrode site with the best electrical characteristics for long-term pacing, achieving precise positioning, stable anchoring, and intelligent electrode site selection. This reduces surgical risks and effectively improves the long-term lifespan and reliability of the device.
[0050] The scheme is further optimized. The energy storage control system includes a battery 7, a controller 8 and a wireless communication module 9. The battery 7, the wireless communication module 9, several microelectrodes 5, the first drive mechanism 2 and the second drive mechanism 6 are all electrically connected to the controller 8.
[0051] The controller 8 is used to control the second drive mechanism 6 to push out the microelectrode 5, and then use the selected microelectrode 5 as the pacing cathode to perform pacing threshold and electrode impedance tests, record the test data of each microelectrode 5, and select one or more optimal pacing electrode sites based on the test data according to the preset algorithm; the optimal pacing electrode site is determined according to the position of the microelectrode 5.
[0052] Battery 7 provides long-term power to the entire device, continuously supplying stable power to controller 8, wireless communication module 9, several microelectrodes 5, and two drive mechanisms, meeting the power needs of the device during long-term implantation. Controller 8, as the core control unit, collects electrical characteristic data of microelectrodes 5 in real time, precisely controlling the start / stop and amplitude of the first drive mechanism 2 and the second drive mechanism 6 (such as the screw depth of the screw rod 3 and the extension length of the microelectrodes 5). Simultaneously, it establishes a remote connection with external devices through wireless communication module 9, transmitting pacing parameters (such as QRS width and pacing threshold), electrode working status, and remaining battery power to the external terminal in real time. It can also receive control commands from the external device (such as adjusting the pacing frequency), enabling remote monitoring and parameter optimization of the device. Device debugging can be completed without a second surgery, improving the convenience and safety of clinical use.
[0053] Further optimization involves adding external threads to the outer wall of the screw rod 3. These threads enhance the mechanical engagement between the screw rod 3 and the myocardial tissue, allowing it to be more securely screwed into the myocardium and preventing loosening or displacement due to continuous cardiac pulsation. Compared to a threadless design, the external threads significantly improve the axial anchoring force of the screw rod 3, providing a more reliable initial positioning basis for the device. Simultaneously, in conjunction with the three-dimensional anchoring structure formed by the subsequent microelectrode 5, this further reduces the overall risk of dislocation, ensuring the device remains in the target position within the left bundle branch region throughout long-term pacing.
[0054] Further optimization of the scheme: the microelectrode 5 is made of a super-elastic nickel-titanium alloy wire, and the end of the microelectrode 5 near the guide channel 4 is set in an arc or hook shape.
[0055] The microelectrode 5 is made of a highly elastic nickel-titanium alloy wire. Its material properties are adapted to the physiological environment of dynamic cardiac pulsation. The superelasticity of the nickel-titanium alloy allows the microelectrode 5 to flexibly bend with the deformation of the myocardium, avoiding pacing failure caused by the breakage of rigid materials, while ensuring that the microelectrode 5 always maintains contact with the myocardial tissue. The end of the microelectrode 5 is designed as an arc or hook shape. On the one hand, it can increase the contact area between the electrode and the myocardial tissue, improve the stability of electrical signal acquisition (such as more accurate acquisition of myocardial electrical activity data) and the effectiveness of pacing signal release. On the other hand, the hook-shaped structure can be slightly embedded in the myocardial surface (without damaging the myocardial tissue), further enhancing the fixation effect of the electrode, preventing the electrode from slipping during cardiac pulsation, and ensuring the reliability of long-term pacing.
[0056] Further optimization of the scheme involves the axes of several guide channels 4 being distributed in a three-dimensional scattering pattern, enabling the extended microelectrodes 5 to be anchored in myocardial tissue at different depths, forming a three-dimensional anchoring structure.
[0057] Further optimization of the design involves using a parylene biocompatible insulating layer. Parylene possesses excellent biocompatibility and chemical stability, and as the insulating layer for the microelectrode 5, it can prevent tissue rejection or corrosion by body fluids after implantation, ensuring long-term safe implantation of the device. Simultaneously, the insulating layer only covers the area of the microelectrode 5 except for its tip, allowing the microelectrode 5 to contact the myocardial tissue only through its exposed tip. This prevents unnecessary electrical coupling between other parts of the electrode and surrounding tissues, concentrates pacing energy at the tip, improves pacing accuracy, and reduces stimulation of myocardial tissue outside the left bundle branch region.
[0058] The design was further optimized so that the end of the microelectrode 5 exposes 1mm to 2mm of the insulating layer.
[0059] Further optimization of the scheme: the first drive mechanism 2 includes a first micro motor and a first push rod. The first micro motor is installed inside the capsule shell 1 and is electrically connected to the controller 8. The first micro motor is used to drive the first push rod to translate. The end of the first push rod away from the first micro motor is fixedly connected to the spiral rod 3.
[0060] The first micro motor starts under the control of the controller 8, driving the first push rod to translate axially through the transmission structure. The first push rod is fixedly connected to the spiral rod 3, thereby causing the spiral rod 3 to extend or retract away from the capsule shell 1. The precise speed control of the first micro motor can achieve uniform translation of the first push rod, ensuring that the spiral rod 3 is screwed into the myocardial tissue at a controllable speed, avoiding myocardial damage due to excessive speed or affecting surgical efficiency due to excessive slowness. At the same time, the forward and reverse function of the motor can realize the screwing in and out of the spiral rod 3, improving the flexibility of device operation. Combined with the external thread of the spiral rod 3, the initial positioning process is more accurate and controllable.
[0061] Further optimization of the scheme: the second drive mechanism 6 includes a second micro motor and a second push rod. The second micro motor is installed inside the screw rod 3 and is electrically connected to the controller 8. The second micro motor is used to drive the second push rod to translate. The end of the second push rod away from the second micro motor is fixedly connected to several micro electrodes 5.
[0062] The second micro motor starts under the control of the controller 8, driving the second push rod to move along the inner cavity of the spiral rod 3. The second push rod is fixedly connected to several micro electrodes 5, and can synchronously drive all micro electrodes 5 to extend or retract along the guide channel 4. The high-precision control of the second micro motor can accurately adjust the extension length of the micro electrodes 5, ensuring that the electrodes form a preset scattering three-dimensional distribution after extension. The exit direction of the guide channel 4 is designed not to be on the same plane, to ensure that the micro electrodes 5 are three-dimensionally distributed after unfolding.
[0063] The scheme was further optimized so that the number of microelectrodes 5 was six.
[0064] In a further optimized design, a number of microelectrodes 5 are fitted with positioning rings 10, which are slidably connected to the inner wall of the screw rod 3. When the second drive mechanism 6 drives the microelectrodes 5 to move along the guide channel 4, the positioning rings 10 can limit the radial offset of each electrode, ensuring that all electrodes always extend along the preset direction of the guide channel 4, forming a uniform scattering distribution.
[0065] How to use:
[0066] Reference Figures 4-5 ,in, Figure 4 The microelectrode 5 extends through the guide channel 4 and forms a three-dimensional anchoring network due to its three-dimensional scattering distribution. This structure can effectively resist the multi-directional stress caused by heartbeat. Figure 5 This visually demonstrates that the axes of the guide channels 4 are not on the same plane, ensuring the three-dimensional spatial distribution of the microelectrodes 5;
[0067] Initial positioning and fixation: Under imaging guidance, the pacemaker is delivered to the target area on the right ventricular septum. The operator activates the first drive mechanism 2 via an external controller, causing the spiral rod 3 to be inserted into the myocardium. During this process, the system monitors the intracardiac electrogram and pacing capture threshold from the spiral rod 3 (as a temporary electrode) in real time.
[0068] • Precise Positioning and Array Deployment: When electrophysiological parameters indicating approach to the left bundle branch region are detected, such as characteristic signals of the left bundle branch potential (LBBAP) (e.g., sharp high-frequency potential deflection) or a significant narrowing of the pacing QRS wave morphology (e.g., narrower than 130 ms), the operator issues a command. The second drive mechanism 6 is activated, extending multiple (e.g., six) microelectrodes 5 from the guide channel 4 at the end of the helical rod 3. Due to their hyperelasticity and pre-formed design, the microelectrodes 5 naturally deploy in a three-dimensional radial pattern after deployment, with an anchoring range much larger than the cross-sectional area of the helical rod 3, resembling a 'mace,' deeply penetrating the surrounding myocardium to achieve secondary stable fixation, significantly enhancing resistance to torsion and pull-out.
[0069] • Significantly reduced risk of dislocation: After deployment, the controller 8 automatically executes a "site optimization program": This program sequentially uses each microelectrode 5 as the pacing cathode and the capsule shell 1 as the anode to test the pacing threshold (e.g., starting from 0.5V in 0.1V increments) and impedance (normal range approximately 300-1000Ω). Simultaneously, it records the sensing sensitivity of each microelectrode 5 under its own heart rhythm (typically required >2.0mV). The controller 8 performs a comprehensive score based on a preset algorithm (e.g., weighted calculation of threshold, impedance, and sensing sensitivity, and reference to the pacing QRS wave width), and recommends 1-3 optimal pacing sites and their test data to an external programmable device via the wireless communication module 9. The operator confirms the final pacing electrode based on the recommendations and real-time waveforms. If the initial test results are unsatisfactory (e.g., all site thresholds are >1.5V), the operator can instruct the controller 8 to retract the microelectrode 5, slightly adjust the angle or depth of the spiral rod 3, and then deploy the electrode bundle again for testing, greatly improving the fault tolerance and success rate of implantation.
[0070] In the description of this invention, it should be understood that the terms "longitudinal", "lateral", "up", "down", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this invention, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention.
[0071] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation of the present invention. For those skilled in the art, other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the claims of the present invention.
Claims
1. A rotating multi-electrode leadless pacemaker for pacing the left bundle branch region, characterized in that, include: Capsule shell (1), wherein an energy storage control system and a first drive mechanism (2) are installed inside the capsule shell (1); A spiral rod (3) is provided, one end of which is connected to the output end of the first driving mechanism (2), and the other end of which slides out to the outside of the capsule shell (1); the spiral rod (3) is hollow inside, and a plurality of guide channels (4) are provided circumferentially on the outer wall of the spiral rod (3) away from the capsule shell (1), and the plurality of guide channels (4) are arranged in a radiating manner; the outer wall of the spiral rod (3) is provided with external threads; A microelectrode bundle, comprising a plurality of microelectrodes (5), one side of the plurality of microelectrodes (5) being fixedly connected, and the other side extending into a plurality of guide channels (4); the microelectrodes (5) are covered with an insulating layer, and one end of the microelectrodes (5) near the guide channels (4) exposes the insulating layer. The second drive mechanism (6) is installed in the inner cavity of the screw rod (3), and the output end of the second drive mechanism (6) is fixedly connected to the end of the micro electrode (5) away from the guide channel (4); Among them, several of the microelectrodes (5), the first driving mechanism (2) and the second driving mechanism (6) are electrically connected to the energy storage control system.
2. The screw-out multi-electrode leadless pacemaker for left bundle branch pacing according to claim 1, characterized in that: The energy storage control system includes a battery (7), a controller (8), and a wireless communication module (9). The battery (7), the wireless communication module (9), a plurality of microelectrodes (5), the first drive mechanism (2), and the second drive mechanism (6) are all electrically connected to the controller (8). The controller (8) is used to control the second drive mechanism (6) to push out the microelectrode (5), and then use the selected microelectrode (5) as the pacing cathode to perform pacing threshold and electrode impedance tests, record the test data of each microelectrode (5), and select one or more optimal pacing electrode sites based on the test data according to the preset algorithm; the optimal pacing electrode site is determined according to the position of the microelectrode (5).
3. The screw-out multi-electrode leadless pacemaker for left bundle branch pacing according to claim 1, characterized in that: The microelectrode (5) is made of a super-elastic nickel-titanium alloy wire, and the end of the microelectrode (5) near the guide channel (4) is set in an arc shape or hook shape.
4. The screw-out multi-electrode leadless pacemaker for left bundle branch pacing according to claim 1, characterized in that: The axes of several of the guide channels (4) are distributed in a three-dimensional scattering pattern, so that the extended microelectrodes (5) can be anchored in myocardial tissue at different depths to form a three-dimensional anchoring structure.
5. The screw-out multi-electrode leadless pacemaker for left bundle branch pacing according to claim 1, characterized in that: The end of the microelectrode (5) protrudes 1 mm to 2 mm from the insulating layer.
6. The screw-out multi-electrode leadless pacemaker for left bundle branch pacing according to claim 2, characterized in that: The first drive mechanism (2) includes a first micro motor and a first push rod. The first micro motor is installed inside the capsule shell (1). The first micro motor is electrically connected to the controller (8). The first micro motor is used to drive the first push rod to translate. The end of the first push rod away from the first micro motor is fixedly connected to the spiral rod (3).
7. The screw-out multi-electrode leadless pacemaker for left bundle branch pacing according to claim 2, characterized in that: The second drive mechanism (6) includes a second micro motor and a second push rod. The second micro motor is installed inside the screw rod (3). The second micro motor is electrically connected to the controller (8). The second micro motor is used to drive the second push rod to translate. The end of the second push rod away from the second micro motor is fixedly connected to a plurality of the micro electrodes (5).
8. The screw-out multi-electrode leadless pacemaker for left bundle branch pacing according to claim 1, characterized in that: The number of microelectrodes (5) is six.
9. The screw-out multi-electrode leadless pacemaker for left bundle branch pacing according to claim 1, characterized in that: A positioning ring (10) is provided on the outer sleeve of several of the micro electrodes (5), and the positioning ring (10) is slidably connected to the inner wall of the spiral rod (3).