Flexible dual chamber leadless pacemaker

Abstract

The application discloses a flexible double-cavity leadless pacemaker, which comprises a battery, a flexible folding integrated circuit, a ventricular electrode needle and an atrial electrode needle. The flexible folding integrated circuit is in a contracted and folded state in a delivery state and is accommodated in a delivery catheter, and is in an unfolded state in a released state. The ventricular electrode needle can be pierced into and fixed to the interventricular septum of the right ventricle. The atrial electrode needle can be pierced into and fixed to the atrial septum of the right atrium. The atrial electrode needle and the ventricular electrode needle are provided with a plurality of stimulation points which are distributed along the axial direction at intervals. A fixed wing is used for embedding into myocardial trabeculae to form auxiliary fixation. The ventricular electrode needle and the atrial electrode needle are electrically connected with the flexible folding integrated circuit. The plurality of ventricular stimulation points and the plurality of atrial stimulation points are connected to a gating switch matrix through printed circuits respectively, so as to be combined and tested in operation and selectively combined as a pacing and sensing electrode point. The application has excellent cardiac mechanics adaptability, can significantly improve the space utilization and the service life, and has flexible pacing electrical performance.

Description

Technical Field

[0001] This invention belongs to the field of active implantable medical device technology, specifically relating to a flexible dual-chamber leadless pacemaker. Background Technology

[0002] A cardiac pacemaker is the primary medical device for treating bradycardia, atrioventricular block, and other slow arrhythmias. Traditional transvenous pacing systems consist of a pulse generator (including battery and circuitry) implanted in a subcutaneous pouch below the clavicle and pacing electrode leads implanted in the heart via a vein. This system has been used clinically for over half a century and is technologically mature, but its inherent drawbacks are also significant: the leads are constantly subjected to the repeated bending environment of cardiac contraction and relaxation, as well as neck / shoulder movements, posing a risk of insulation damage and conductor breakage; the subcutaneous pouch provides a breeding ground for bacteria, potentially leading to serious complications such as pouch infection and skin ulceration; furthermore, as a foreign body within the blood vessel, the leads can induce subclavian vein thrombosis and even superior vena cava syndrome. Once these complications occur, repeated surgical intervention is often required, significantly increasing patient suffering and the medical burden.

[0003] To fundamentally avoid lead-related complications, leadless pacemakers have emerged and become an important technological direction in the field of cardiac pacing. Currently, representative products that have achieved commercial application mainly include Medtronic's Micra VR series and Abbott's Aveir DR series.

[0004] Medtronic's Micra VR series features a unibody rigid metal casing with four hook-shaped anchors at the head end, which are used to anchor the device by hooking into the subendocardial trabeculae of the right ventricle. The internal circuit module and battery module are arranged in series along the longitudinal axis, with a volume ratio of approximately 1:1.

[0005] The Abbott Aveir DR series also employs a rigid packaging structure, achieving anchoring through a spiral metal fixation device at the head end that can actively screw into the myocardium. The volume ratio of its internal circuit module to the battery module is approximately 1:2, resulting in a slightly increased proportion of space occupied by the battery.

[0006] In the aforementioned existing products, the entire pacemaker body is rigidly housed within the protective sheath at the end of the delivery catheter during delivery, leaving extremely limited available space within the delivery system.

[0007] Based on existing leadless pacemaker technologies, such as Medtronic Micra VR and Abbott Aveir DR, their common technical shortcomings can be summarized as follows:

[0008] Firstly, the delivery passage is limited. The overall rigid encapsulation structure cannot conform to the natural curvature of blood vessels in the complex anatomical path of the femoral vein-inferior vena cava-right atrium. The delivery catheter has high resistance when turning and poor maneuverability, which not only prolongs the operation time, but may also damage the blood vessel wall or heart chamber structure, especially in infants and patients with small blood vessels.

[0009] Secondly, it is incompatible with the dynamic biomechanical environment of the heart. Rigid structures cannot adapt to the continuous alternating stress generated by cardiac contraction and relaxation. After implantation, stress concentration occurs at the fixation interface, which can easily lead to chronic compression of myocardial tissue, aggravated inflammatory response, and a significant increase in the risk of loosening or even dislocation of the fixation structure in the long term.

[0010] Third, the internal space utilization is low. The circuit module and battery module are each independently rigidly packaged and arranged in series inside the pacemaker housing, with a volume ratio of approximately 1:1 or 1:2. The circuit section occupies a large amount of valuable space. With the pacemaker's external dimensions limited by vascular delivery capacity, battery capacity is severely restricted, directly affecting the pacemaker's lifespan.

[0011] Fourth, the fixation structure is singular, resulting in insufficient anchoring reliability. Whether hook-shaped or spiral fixation is used, it is a single type of anchoring method. A single fixation structure has limited adaptability to myocardial tissue conditions. In cases of thin myocardium, poor trabecular development, or postoperative tissue remodeling, there is a risk of pacemaker displacement or dislodgement. If this occurs, a second surgery is required to remove and re-implant the pacemaker.

[0012] Fifth, the pacing / sensing point is singular, and electrical parameters cannot be optimized intraoperatively. The pacing electrode is set at only a single stimulation point, and the circuit cannot be adjusted and optimized intraoperatively based on the measured pacing threshold, sensing amplitude, and impedance value. This results in the pacing energy consumption not being reduced to the minimum, further shortening the actual working life of the pacemaker.

[0013] Sixth, the rigid structure poses a risk of damage to the delicate anatomical structures of the heart. When the rigid pacemaker body moves relative to the surrounding tissues during cardiac contraction, it can cause frictional or impact damage to delicate structures such as the conduction bundle, papillary muscles, and chordae tendineae, inducing additional complications.

[0014] Therefore, how to provide a flexible dual-chamber leadless pacemaker is a problem that urgently needs to be solved by those skilled in the art. Summary of the Invention

[0015] In view of this, the present invention provides a flexible dual-chamber leadless pacemaker with excellent delivery permeability and cardiac biomechanical compatibility, reliable fixation, significantly improved space utilization and service life, and flexible pacing electrical performance.

[0016] To achieve the above objectives, the present invention adopts the following technical solution: a flexible dual-chamber leadless pacemaker, comprising: A battery with lead-out electrodes; The flexible folding integrated circuit is electrically connected to the lead electrode of the battery. In the delivery state, the flexible folding integrated circuit is in a contracted folded state and stored in the delivery conduit. In the release state, the flexible folding integrated circuit is in an unfolded state, and the flexible substrate of the flexible folding integrated circuit can passively deform with the heartbeat. The ventricular electrode needle has a pointed structure that can be inserted into and fixed to the interventricular septum of the right ventricle. The ventricular electrode needle is provided with multiple ventricular stimulation points that are spaced apart along the axial direction. The atrial electrode needle has a pointed structure and can be inserted into and fixed in the interatrial septum of the right atrium. The atrial electrode needle is provided with multiple atrial stimulation points distributed along the axial direction. A fixed wing, disposed on the battery, is used to embed into the trabeculae of the myocardium to form auxiliary fixation; The ventricular electrode needle and the atrial electrode needle are respectively electrically connected to the flexible folding integrated circuit, and the flexible folding integrated circuit includes a gating switch matrix. Multiple ventricular stimulation points and multiple atrial stimulation points are respectively connected to the gating switch matrix through printed circuits to combine and test during surgery and selectively combine them as pacing sensing electrode points. The ventricular electrode needle can pace the right ventricle, and the atrial electrode needle can pace the right atrium, thus achieving atrioventricular sequential pacing.

[0017] The beneficial technical effects of this invention are as follows: the flexible foldable integrated circuit can shrink and fold during delivery and unfold after release, which can improve space efficiency and achieve flexible delivery. At the same time, it can also relatively increase the volume and capacity of the battery and extend its service life. The substrate can passively deform with the heartbeat, which has extremely strong biomechanical adaptability. Multi-point anchoring improves the fixation reliability of the entire pacemaker in the heart. It can also select the optimal pacing sensing electrode position during surgery, which improves the pacing electrical performance.

[0018] Preferably, in the transport state, the space occupied by the flexible folding integrated circuit within the transport conduit is smaller than the space occupied by the battery.

[0019] The resulting technical effect is that the flexible foldable integrated circuit provides a prerequisite for large-capacity batteries, breaking the inherent volume constraints of "rigid circuits". That is, the circuit actively makes room during the delivery stage, allowing the battery to be expanded, thereby achieving a significant extension of pacemaker life with the same delivery catheter volume.

[0020] Preferably, the thickness of the flexible substrate is 0.01mm to 0.5mm, and the bending radius of the flexible substrate is less than or equal to 1 / 3 of the inner diameter of the delivery conduit.

[0021] The resulting technical effect is that, without changing the structure and performance of the existing delivery catheter, the pacemaker is adapted to the performance of the delivery catheter. By limiting the thickness and bending radius of the flexible substrate, the mechanical effect is ensured that the substrate can be "folded tightly without breaking" during delivery and "bends without getting tired or breaking" after long-term implantation.

[0022] Preferably, the tip structure of the ventricular electrode needle is inserted into the interventricular septum of the right ventricle, the tip structure of the atrial electrode needle is inserted into the interatrial septum of the right atrium, and the fixed wing is embedded in the myocardial trabeculae to form multi-point anchoring.

[0023] The resulting technical effect is that by combining the actively screwed-in helical electrode with the passively embedded fixed wing, a multi-point, three-dimensional composite anchoring system is formed in the right ventricle and right atrium, thereby achieving long-term, stable, and safe fixation of the pacemaker in the dynamic mechanical environment of the heart, and providing reliable support for the pulsational compliance of the flexible circuit.

[0024] Preferably, there are multiple fixed wings, which are distributed at intervals along the circumference of the battery.

[0025] The resulting technical effect is that multiple fixed wings can prevent rotation in all directions, making the battery more stable, distributing the force, protecting tissue, and providing structural protection for the long-term stable anchoring of the pacemaker in the heart.

[0026] Preferably, at least a portion of the surface of the flexible foldable integrated circuit is covered with a paraffin coating, which provides electrical insulation and body fluid protection.

[0027] The resulting technical effect is that by introducing the Pyrelin coating, with the triple advantages of "dense insulation + biocompatibility + non-destructive process", it provides implantable-grade encapsulation protection for the flexible folding integrated circuit, enabling all electrical innovations of the pacemaker (flexible folding, switching matrix, multi-point stimulation) to operate stably for decades in the humid, dynamic, and corrosive environment of the heart chamber, while reducing inflammatory response and fibrous encapsulation, and extending the effective life of the device.

[0028] Preferably, the flexible substrate is made of polyimide.

[0029] The resulting technical effect is that polyimide, as the flexible substrate material, is the preferred material for the verification of implantable medical devices, and has multiple comprehensive advantages such as thermal stability, high flexibility, fatigue resistance, and easy mass production.

[0030] Preferably, the flexible folding integrated circuit further includes a pacing control circuit and a pacing drive circuit integrated on the flexible substrate.

[0031] The resulting technical effect is that by integrating the pacing control circuit and the drive circuit onto the flexible substrate, the flexible folding integrated circuit is upgraded from a "passive lead carrier" to an "active intelligent terminal". It not only undertakes the traditional pacing decision and pulse output functions, but also eliminates the volume redundancy of independent packaging through chip integration, providing a structural prerequisite for battery capacity expansion and circuit folding. At the same time, through built-in programmable logic, it realizes the point switching of the gating switch matrix and the timing control of atrioventricular sequential pacing.

[0032] Preferably, the flexible folding integrated circuit is provided with a imaging module for displaying the orientation of the flexible folding integrated circuit under X-ray.

[0033] The resulting technical effects are as follows: by setting an X-ray imaging module on the flexible folding integrated circuit, a "visual orientation mark" is provided for the flexible circuit body during and after surgery. This solves the problem of release and positioning caused by the invisibility of flexible materials during surgery, allowing the surgeon to confirm that the flexible circuit is fully unfolded and correctly oriented. After surgery, it supports long-term follow-up monitoring, assists in analyzing the long-term pacing performance of different anatomical locations, and provides anatomical orientation reference for the switching of stimulation points of the gating switch matrix.

[0034] Preferably, the battery is a high-capacity micro flexible battery. The battery housing space released by the flexible folding integrated circuit in the folded state increases the volume of the battery by 30% to 50% compared to using a rigid circuit board, while keeping the same pacemaker housing volume.

[0035] The resulting technological effect is to concentrate all the spatial benefits brought by flexible foldable integrated circuits into the core clinical value of "significantly increasing pacemaker lifespan under the same level of trauma". Attached Figure Description

[0036] Figure 1 This is a schematic diagram of the main structure of a flexible dual-chamber leadless pacemaker according to the present invention; Figure 2 This is a schematic diagram of a flexible dual-cavity leadless pacemaker of the present invention in delivery mode; Figure 3 This is a schematic diagram of a flexible dual-lumen leadless pacemaker of the present invention used in conjunction with a delivery catheter; Figure 4 This is an overall circuit diagram of a flexible integrated circuit for a flexible dual-cavity leadless pacemaker according to the present invention; Figure 5 This is a schematic diagram of the circuit structure layout of a flexible integrated circuit for a flexible dual-cavity leadless pacemaker according to the present invention. Figure 6 This is a schematic diagram illustrating the application of a flexible dual-chamber leadless pacemaker according to the present invention.

[0037] 1 Battery, 2 Flexible folding integrated circuit, 3 Ventricular electrode needle, 31 First ventricular electrode stimulation point, 32 Second ventricular electrode stimulation point, 33 Third ventricular electrode stimulation point, 34 Fourth ventricular electrode stimulation point, 4 Atrial electrode needle, 41 First atrial stimulation point, 42 Second atrial stimulation point, 5 Fixing wing, 6 Delivery catheter, 7 Protective sleeve, 8 Imaging module, 9 Wiring hole, 10 Tip structure, 101 Barb section, 11 Guide wire insertion hole. Detailed Implementation

[0038] 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.

[0039] See the appendix of this invention. Figures 1 to 6 According to an embodiment of the present invention, a flexible dual-chamber leadless pacemaker includes: Battery 1 has lead-out electrodes. In specific applications, a flexible battery can be selected to improve the overall adaptability of the pacemaker. The flexible folding integrated circuit 2, serving as the "nerve center" of the pacemaker, integrates all electronic functions on a flexible substrate. It is a dynamic circuit system with three states: foldable delivery, unfoldable operation, and deformable adaptation. Electrically connected to the lead-out electrodes of the battery 1, the flexible folding integrated circuit 2 is in a contracted folded state and housed within the delivery catheter 6, thus freeing up space for the battery to expand in size and capacity. In the unfolded state, the flexible folding integrated circuit 2 is in an unfolded state, and its flexible substrate can passively deform with heartbeats, exhibiting strong biological adaptability. Using the flexible folding integrated circuit increases the battery volume by 30% to 50% compared to a rigid pacemaker with a circuit-to-battery volume ratio of 1:1 or 1:2, correspondingly increasing the pacemaker's lifespan by 30% to 50%.

[0040] The ventricular electrode needle 3 has a tip structure 10, which can be inserted into and fixed to the interventricular septum of the right ventricle. The ventricular electrode needle 3 is provided with multiple ventricular stimulation points distributed along the axial direction. The atrial electrode needle 4 has a tip structure 10, which can be inserted into and fixed to the right atrial septum. The atrial electrode needle 4 is provided with multiple atrial stimulation points distributed along the axial direction. The tip structure 10 is also provided with a barb 101, which is used to prevent withdrawal after piercing the myocardium and to achieve a fixation effect; The fixed wing 5, which can be a hook, is mounted on the battery 1 and is used to embed into the myocardial trabeculae to form auxiliary fixation; Ventricular electrode needle 3 and atrial electrode needle 4 are electrically connected to flexible folding integrated circuit 2, and flexible folding integrated circuit 2 includes a gating switch matrix. Multiple ventricular stimulation points and multiple atrial stimulation points are connected to the gating switch matrix through printed circuits to combine and test during the operation and selectively combine them as pacing sensing electrode points. Ventricular electrode needle 3 can pace the right ventricle, and atrial electrode needle 4 can pace the right atrium, thus achieving atrioventricular sequential pacing.

[0041] The ventricular electrode needle 3 and the atrial electrode needle 4 are provided with guide wire insertion holes 11 at their tail ends. They are used in conjunction with guide wires to complete the process of pushing the electrode needles and inserting them into the myocardium.

[0042] In this embodiment, the matrix is ​​not a traditional single switch, but a switch array composed of multiple micro electronic switches.

[0043] Specifically, the gating switch matrix includes: Input port group: contains multiple independent input channels, each of which is connected to a ventricular stimulation point or atrial stimulation point through an independent wire.

[0044] Output port: Connected to the pacing control circuit and / or sensing amplifier circuit of the flexible folding integrated circuit 2.

[0045] Switch array: Located between the input port group and the output port, it consists of multiple transistor switches (such as MOSFETs, metal-oxide-semiconductor field-effect transistors) arranged in a matrix of rows and columns.

[0046] Decoding and driving circuit: used to receive external programmable commands or internal preset logic commands, and convert the commands into specific on / off control signals.

[0047] Working principle and intraoperative operation Working principle: After receiving the selection command, the decoding drive circuit controls the closure of specific horizontal and vertical switches in the switch array. Through this "row-column cross-selection" method, the system can connect any one or more input channels (i.e., stimulation points) to the output port, while unselected channels remain in a high-impedance state (physically disconnected).

[0048] Intraoperative combination test procedure: Release and initial testing: After the pacemaker is released and multi-point anchoring is completed, the physician first sends commands via an external programmer.

[0049] Test one by one: Control the gating switch matrix to sequentially select each independent stimulation point (e.g., point 1 → point 2 → point 3…), and record the key parameters such as intracardiac electrogram amplitude, pacing threshold and impedance for each point.

[0050] Combination screening: Based on the test data, the doctor selects the optimal single point or combination of points using a programmer (e.g., combining ventricular point 3 with atrial point 1). After receiving the combination command, the gating switch matrix will simultaneously activate the selected multiple input channels to the output port, forming a dedicated pacemaker sensing electrode pair.

[0051] Parameter solidification: After the test is completed, the gating combination state is stored in the non-volatile memory of the pacing control circuit as a fixed working mode for the patient's long-term treatment.

[0052] In other embodiments, in the transport state, the flexible folding integrated circuit 2 occupies less space within the transport conduit 6 than the battery 1.

[0053] In other specific embodiments, the thickness of the flexible substrate is 0.01mm to 0.5mm, and the bending radius of the flexible substrate is less than or equal to 1 / 3 of the inner diameter of the delivery conduit 6, so that no plastic deformation or damage to electrical performance occurs during the delivery process.

[0054] In some other embodiments, the tip structure of the ventricular electrode needle 3 is inserted into the interventricular septum of the right ventricle, the tip structure of the atrial electrode needle 4 is inserted into the interatrial septum of the right atrium, and the fixing wing 5 is embedded in the myocardial trabeculae to form multi-point anchoring.

[0055] In some other specific embodiments, there are multiple fixed wings 5, which are distributed at intervals along the circumference of the battery 1.

[0056] In some other embodiments, at least a portion of the surface of the flexible foldable integrated circuit 2 is covered with a paraffin coating, which provides electrical insulation and body fluid protection.

[0057] In practice, the flexible substrate is made of polyimide.

[0058] In some other embodiments, the flexible folding integrated circuit 2 also includes a pacing control circuit and a pacing drive circuit integrated on a flexible substrate.

[0059] In some other specific embodiments, the flexible folding integrated circuit 2 is provided with a developing module 8, which may specifically include a "D" developing mark, used to display the orientation of the flexible folding integrated circuit 2 under X-ray.

[0060] In some other embodiments, battery 1 is a high-capacity micro flexible battery. The battery housing space released by the flexible folding integrated circuit 2 in the folded state increases the volume of battery 1 by 30% to 50% compared to using a rigid circuit board, while keeping the same pacemaker housing volume.

[0061] An example of a high-capacity micro flexible battery is a thin-film battery with a five-layer stacked structure, which is tightly bonded by a hot-pressing lamination process, with a total thickness controlled at 0.4-0.7mm, combining ultra-thinness with high flexibility.

[0062] Specifically, from top to bottom, the structure consists of a medical-grade polymer upper encapsulation layer, a lithium metal foil negative electrode sheet, a PEO / LiTFSI-based composite solid electrolyte membrane, a core self-supporting flexible lithium fluoride carbon positive electrode sheet (prepared through a dry fiberization process, without metal current collectors), and a lower encapsulation layer. Each layer is integrally encapsulated by hot-pressing, with a total thickness controlled between 0.4-0.7 mm. In practical applications, these layers can be connected in parallel to increase the total capacity, providing the pacemaker with a lifespan of 8-12 years. Furthermore, its ultra-thin and flexible structure allows the entire device to be compacted during delivery, combining high energy density, high safety, excellent bending reliability, and minimally invasive implantation adaptability.

[0063] This invention replaces the traditional rigid circuit with a flexible folding integrated circuit. By folding the flexible circuit part and storing it in the delivery conduit system, it systematically solves the defects of the existing technology from three dimensions: structure, electricity and mechanics.

[0064] Structural dimension: The flexible circuit can be folded and retracted into the protective sleeve during delivery, freeing up internal space in the pacemaker body, increasing battery volume by 30% to 50%, and correspondingly increasing pacemaker life by 30% to 50%.

[0065] Mechanical dimension: The compliance of flexible circuits allows them to passively deform with the contraction and relaxation of the heart after implantation, solving the problem of mismatch between rigid structures and the dynamic mechanical environment of the heart.

[0066] Electrical dimension: Set multiple stimulation points (e.g., select any two out of four points), select the optimal pacing circuit through intraoperative combination testing, reduce contact impedance, and improve energy utilization efficiency.

[0067] Fixed dimension: The multi-point fixing structure (hook + double helix needle) is adopted, which significantly reduces the risk of detachment from a single fixing structure.

[0068] The working principle and clinical operation procedure of this invention are as follows.

[0069] Preoperative preparation The procedure was performed in the interventional catheterization lab. Local anesthesia was administered to the femoral vein puncture site while the patient was awake. The physician used an external programmer to communicate with the pacemaker and preset its parameters. The atrial and ventricular electrodes of the flexible dual-chamber leadless pacemaker, along with the flexible foldable integrated circuit (in a folded state) and the battery, were sequentially placed into the protective sleeve of the delivery catheter system. The atrial and ventricular electrodes were then secured to the guidewire in the delivery catheter system using a screw-on fixing structure.

[0070] Establish a pathway After puncture and dilation of the femoral vein sheath, the delivery system is inserted into the right atrium entrance via the femoral vein, iliac vein, and inferior vena cava to establish a pathway for pacemaker implantation.

[0071] Navigation and Positioning Under X-ray guidance, the delivery catheter containing the pacemaker is advanced along the pathway into the right ventricle. The catheter position is adjusted so that the tip of the pacemaker is aligned with the mid-septum of the right ventricle. Contrast agent is injected to confirm good contact between the catheter tip and the myocardium.

[0072] Release and fixation Operate the delivery system handle to push the pacemaker's battery out of the protective sleeve, first releasing the fixation wing so that the hooks engage with the myocardial trabeculae.

[0073] Gently pull back the conveyor system. Once you confirm that the battery is in a stable position, disconnect the pull rope connecting the conveyor system to the battery.

[0074] Release the ventricular electrode needle and push the control wire to insert it into the mid-septum of the right ventricle to complete ventricular fixation.

[0075] Adjust the delivery system to the right atrium, release the atrial electrode needle so that it pierces the interatrial septum of the right atrium, and complete the atrial fixation.

[0076] Electrical Testing and Multi-Point Optimization After all fixation is completed, electrical tests are performed using an external programmer. Taking the four stimulation points on the ventricular electrode needle as an example, two points are randomly selected, resulting in six combinations (e.g., points 31-32, 31-33, 31-34, 32-33, 32-34, 33-34). The pacing threshold, sensing amplitude, and impedance value are tested for each combination, and the two points with the best electrical test results (lowest pacing threshold, highest sensing amplitude, and moderate and stable impedance) are selected as long-term pacing sensing electrode points.

[0077] Withdrawal Conveyor System After the test is passed, the guidewire is disconnected from the electrode needle, the delivery catheter system is withdrawn, and pressure is applied to the puncture site to stop bleeding.

[0078] The apparatus and methods disclosed in the embodiments are described simply because they correspond to the methods disclosed in the embodiments. For relevant details, please refer to the method section.

[0079] The above description of the disclosed embodiments enables those skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A flexible dual chamber leadless pacemaker, characterized in that, include: Battery (1) has lead-out electrodes; The flexible folding integrated circuit (2) is electrically connected to the lead electrode of the battery (1). In the delivery state, the flexible folding integrated circuit (2) is in a contracted folded state and stored in the delivery conduit (6). In the release state, the flexible folding integrated circuit (2) is in an unfolded state, and the flexible substrate of the flexible folding integrated circuit (2) can passively deform with the heartbeat. The ventricular electrode needle (3) has a pointed structure that can be inserted into and fixed to the interventricular septum of the right ventricle. The ventricular electrode needle (3) is provided with multiple ventricular stimulation points that are spaced apart along the axial direction. The atrial electrode needle (4) has a pointed structure and can be inserted into and fixed in the interatrial septum of the right atrium. The atrial electrode needle (4) is provided with a plurality of atrial stimulation points distributed along the axial direction. A fixed wing (5) is disposed on the battery (1) and is used to embed into the myocardial trabeculae to form auxiliary fixation; The ventricular electrode needle (3) and the atrial electrode needle (4) are electrically connected to the flexible folding integrated circuit (2), and the flexible folding integrated circuit (2) includes a gating switch matrix. Multiple ventricular stimulation points and multiple atrial stimulation points are connected to the gating switch matrix through printed circuits to combine and test during surgery and selectively combine them as pacing sensing electrode points. The ventricular electrode needle (3) can pace the right ventricle, and the atrial electrode needle (4) can pace the right atrium, thus achieving atrioventricular sequential pacing.

2. A flexible dual chamber leadless pacemaker according to claim 1, characterized in that, In the transport state, the space volume occupied by the flexible folding integrated circuit (2) in the transport conduit (6) is smaller than the space volume occupied by the battery (1).

3. A flexible dual chamber leadless pacemaker according to claim 1, wherein, The thickness of the flexible substrate is 0.01mm to 0.5mm, and the bending radius of the flexible substrate is less than or equal to 1 / 3 of the inner diameter of the delivery conduit (6).

4. The flexible dual chamber leadless pacemaker of claim 1, wherein, The tip structure of the ventricular electrode needle (3) pierces the interventricular septum of the right ventricle, the tip structure of the atrial electrode needle (4) pierces the interatrial septum of the right atrium, and together with the fixed wing (5) embedded in the myocardial trabeculae, they form a multi-point anchoring.

5. The flexible dual chamber leadless pacemaker of claim 1, wherein, The number of fixed wings (5) is multiple, and the multiple fixed wings (5) are distributed at intervals along the circumference of the battery (1).

6. A flexible dual chamber leadless pacemaker according to claim 1, wherein, At least a portion of the surface of the flexible foldable integrated circuit (2) is covered with a paraffin coating, which provides electrical insulation and body fluid protection.

7. A flexible dual-chamber leadless pacemaker according to claim 1, characterized in that, The flexible substrate is made of polyimide.

8. A flexible dual-chamber leadless pacemaker according to claim 1, characterized in that, The flexible folding integrated circuit (2) also includes a pacing control circuit and a pacing drive circuit integrated on the flexible substrate.

9. A flexible dual-chamber leadless pacemaker according to claim 1, characterized in that, The flexible folding integrated circuit (2) is provided with a developing module (8) for displaying the orientation of the flexible folding integrated circuit (2) under X-ray.

10. A flexible dual-chamber leadless pacemaker according to any one of claims 1-9, characterized in that, The battery (1) is a high-capacity micro flexible battery. The battery-accommodating space released by the flexible folding integrated circuit (2) in the folded state increases the volume of the battery (1) by 30% to 50% compared to the use of a rigid circuit board, under the same pacemaker housing volume.

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