Implant delivery system, cardiac rhythm adjustment system, and cardiac rhythm adjustment method

Abstract

An implant delivery system, a cardiac rhythm adjustment system, and a cardiac rhythm adjustment method. The implant delivery system comprises a puncture sheath (20) and an implant. The puncture sheath (20) comprises a hollow tube body (12). The implant is releasably disposed in the tube body (12), a distal end of the tube body (12) is a puncture head (13) which can pierce into the ventricular muscle and guide the tube body (12) to pass through the ventricular muscle, and the length of the tube body (12) at least is able to extend into the ventricular muscle from the outside via the apex (4). The implant is an implantable electrode (60, 61, 62, 63, 64, 65, 66), and implantation via an intramyocardial route is used for the electrode (60, 61, 62, 63, 64, 65, 66), so as to achieve real physiological position pacing and biventricular electrical synchronization by means of program control of a pulse generator (80).

Description

Implant delivery system, cardiac rhythm adjustment system, and cardiac rhythm adjustment method Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to an implant delivery system, a cardiac rhythm adjustment system, and a cardiac rhythm adjustment method. Background Art

[0002] In the prior art, implants are usually delivered to the human myocardium via the endocardium, such as delivering hydrogels, drugs, and electrodes. Cardiac implantable device treatments include ordinary pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac synchronized three-chamber pacemakers (CRT / CRT-Ds), which are commonly used treatments for slow arrhythmias, prevention and treatment of malignant ventricular arrhythmias, and treatment of severe heart failure with left bundle branch block. Currently, the above-mentioned devices are mainly implanted via the endocardial route. One of the left ventricular electrode wires of CRT / CRT-D reaches the left ventricular epicardium mainly through the coronary venous system.

[0003] Conventional pacemakers that pace the heart through the endocardium are not physiological pacemakers. After the pacemaker lead is fixed to the endocardium, the initial electrical impulse directly excites the myocardial cells at the lead site, causing premature localized excitation. Simultaneously, the electrical signal is transmitted through intercardial signaling pathways and propagates to the surrounding area, triggering excitation of myocardial cells in other locations and producing cardiac contraction. This pacing method offers a simple, rapid, and reliable implantation method, enabling stable pacing thresholds and effectively treating bradyarrhythmias. However, it alters the normal electrophysiological activation sequence of the heart, leading to electrical desynchronization between the atrioventricular and biventricular compartments, and ultimately to mechanical desynchronization of cardiac contraction. Numerous clinical studies have confirmed that high-volume right ventricular pacing increases the incidence of atrial fibrillation and heart failure, impacting patients' long-term prognosis. Although His bundle pacing has become a new hot topic in recent years, the specific anatomy of the His bundle and its surrounding structures makes it difficult to perform, and its long-term efficacy and stability remain uncertain.

[0004] Cardioverter defibrillators (ICDs) have a higher risk of lead-related complications. In addition to the pacing function for slow arrhythmias, when a life-threatening malignant arrhythmia event is detected, the ICD will trigger electrical therapy according to the ICD's programmed parameters. The treatment methods include anti-tachycardia pacing, low-energy cardioversion, and high-energy defibrillation. Whether it is a single-chamber or dual-chamber ICD, the biggest difference between it and an ordinary pacemaker is that it requires a special right ventricular endocardial electrode. The right ventricular defibrillator electrode needs to withstand higher instantaneous high-energy discharges and is usually thicker and harder than ordinary right ventricular pacing electrodes. The incidence of complications related to the implantation of the right ventricular lead of the ICD is much higher than that of ordinary right ventricular pacing leads, including electrode breakage, insulation damage, vascular damage, etc. Once the defibrillation lead is abnormal, it may lead to serious consequences, such as ICD mis-discharge or non-discharge.

[0005] The efficacy of cardiac resynchronization therapy (CRT) is affected by multiple factors. Literature reports indicate that approximately 30% of heart failure patients receiving CRT have no response or a poor response to CRT. During CRT implantation, the left ventricular lead needs to be implanted into the left ventricular epicardium through the coronary venous system. The ideal implantation site for the left ventricular lead is the left ventricular late activation point. Whether the left ventricular lead can be implanted into this ideal site is highly dependent on the course of the coronary veins and the morphology of the coronary vein branches. It is generally recommended that the target vessel for left ventricular lead implantation be the lateral or posterior coronary vein. Once the patient's coronary venous anatomy exhibits severe variations, poor vascular conditions, or limitations such as phrenic nerve stimulation, the left ventricular lead cannot be directly implanted into the optimal target vessel through the coronary veins, and the response rate to CRT treatment will decrease. Technical issues

[0006] Although guidelines recommend direct fixation of the left ventricular lead to the epicardium of the left ventricular target vessel region under direct vision through cardiac surgery (thoracoscopic surgery), this approach remains challenging and limited in practice. Recent literature reports suggest that such patients can undergo direct left ventricular endocardial pacing via the atrial or ventricular septum, thereby achieving cardiac resynchronization therapy. However, it should be noted that patients receiving direct left ventricular endocardial pacing require long-term oral anticoagulation to prevent left ventricular systemic thrombosis. Technical Solutions

[0007] In order to solve the above technical problems, the present application provides an implant delivery system, comprising: a puncture sheath and an implant;

[0008] The puncture sheath includes a hollow tube body, the implant can be releasably placed in the tube body, the distal end of the tube body is a puncture head that can penetrate the ventricular myocardium and guide the tube body to pass through the ventricular myocardium, and the length of the tube body can at least extend from the outside of the body through the apex to the inside of the ventricular myocardium.

[0009] Preferably, the implant is a hydrogel or a therapeutic drug.

[0010] Preferably, a pushing device is slidably provided in the tube body, and the distal end of the pushing device can push the implant to release the tube body.

[0011] Preferably, the pushing device is tubular and has a guide channel inside. A connecting wire is fixed to the proximal end of the implant or is releasably provided with a connecting wire, and the connecting wire extends to the proximal end through the guide channel.

[0012] Preferably, the interior of the tube body includes a first cavity and a second cavity, the two cavities extending side by side from the distal end to the proximal end, and a plurality of implants are arranged in the first cavity along the length direction;

[0013] There is a partition between the two cavities, and the partition is arranged with multiple avoidance holes. For each implant, there is at least one avoidance hole on the proximal side of the implant. The connecting line of each implant extends from the avoidance hole to the second cavity, and extends from the second cavity to the proximal end of the tube body.

[0014] Preferably, an interactive damping structure is provided between the first cavity and each implant.

[0015] Preferably, a pushing device is provided in the second cavity, and the pushing device is tubular and used to receive the connecting line.

[0016] Preferably, the pushing device can enter the first cavity along the connecting line through the corresponding avoidance hole and push the corresponding implant. Preferably, the connecting line is a guide wire or a traction wire.

[0017] Preferably, a plurality of cavities are arranged side by side inside the tube body, and there are multiple implants, each implant being arranged in a different cavity;

[0018] A pushing device is slidably provided in the tube body, and the distal end of the pushing device can push the implant to release the implant from the tube body.

[0019] Preferably, the implant is an implanted electrode, the system further comprises a pulse generator, the electrode and the pulse generator are arranged separately, and the electrode has a smooth outer surface; or

[0020] The electrode and the pulse generator are integrated and have a smooth outer surface after integration.

[0021] Preferably, the implant is an implantable electrode, the system further comprises a pulse generator, the electrode has an anchoring member acting on surrounding tissues, and the electrode and the pulse generator are arranged separately or integrated.

[0022] Preferably, a bending adjustment wire is movably provided in the tube body, the distal end of the bending adjustment wire is connected to the inner wall of the puncture head, and the proximal end of the bending adjustment wire extends out of the tube body as a force-applying end for pulling the puncture head to change its direction.

[0023] Preferably, the implant delivery system further comprises a guiding device, the guiding device comprising a base fixable on the body surface and an adapter seat mounted on the base with an adjustable position, and the puncture sheath is assembled on the adapter seat.

[0024] Preferably, an arc-shaped guide rail is fixed on the base, the adapter seat is slidably positioned on the arc-shaped guide rail, and the puncture sheath is movably positioned and passed through the adapter seat.

[0025] Preferably, the implant delivery system further comprises an imaging system for guiding puncture of the puncture sheath and displaying the position of the implant;

[0026] The adapter is provided with an ultrasonic probe, which collects the implant position and puncture sheath posture in real time and simulates and displays them through the imaging system;

[0027] During simulation display, the implant position and the puncture sheath posture are displayed at corresponding positions of the pre-built heart model for comparison with the predetermined implant position.

[0028] Preferably, the implantation site of the implant is a predetermined electrical stimulation site, and the predetermined electrical stimulation site is located at at least one of the ventricular septum myocardium, the left ventricular free wall myocardium or the right ventricular free wall myocardium; one of the predetermined electrical stimulation sites is close to the terminal bifurcation of the His bundle, or one of the predetermined electrical stimulation sites is close to the left branch of the atrioventricular bundle or the right branch of the atrioventricular bundle.

[0029] At the same time, the present application also provides a cardiac rhythm adjustment system, including:

[0030] There is at least one electrode that can be placed in the ventricular myocardium;

[0031] a pulse generator connected to the electrode via a circuit, wherein the electrode and the pulse generator are arranged separately or integrated;

[0032] The puncture sheath comprises a hollow tubular body, in which the electrode is releasably placed, and the distal end of the tubular body is a puncture head that can penetrate the ventricular myocardium and guide the tubular body to pass through the ventricular myocardium. The length of the tubular body can at least extend from the outside of the body through the apex to the inside of the ventricular myocardium.

[0033] In the present application, after the electrode is implanted, it is located in the ventricular myocardium in the working state. By inputting a specified electrical signal to the electrode, electrical stimulation is applied to the corresponding position in the ventricular myocardium, i.e., the electrical stimulation site, to intervene in or adjust the heart rhythm. As for its working principle and circuit driving method, conventional technology can be used.

[0034] There is no strict limit to the number of electrodes, such as one or more than two, which are arranged at corresponding positions in the ventricular myocardium as needed.

[0035] Preferably, the electrode enters the ventricular myocardium from the epicardium and is located between the epicardium and the endocardium.

[0036] That is, the electrode has an implantation path from the epicardium into the ventricular myocardium, and is located between the epicardium and the endocardium in a working state.

[0037] In the present application, the electrode preferably enters the ventricular myocardium from the epicardium rather than from the endocardium. That is, the electrode has an implantation path from the epicardium into the ventricular myocardium, and after entering the ventricular myocardium, it should avoid passing out from the endocardium. That is, the electrode itself is between the epicardium and the endocardium. If the electrical signal is input by wire, the wire extends through the epicardium to the electrode in the ventricular myocardium.

[0038] Preferably, the electrodes are sequentially inserted into the ventricular myocardium through the body surface and the epicardium.

[0039] The preferred implantation route for the electrodes to contact and pass through the epicardium is from outside the body, for example, implanted between the ribs under the guidance of a puncture sheath.

[0040] Preferably, the electrode enters the ventricular myocardium from the epicardium at the apex of the heart.

[0041] The nerves at the apex of the heart are relatively sparse, so puncturing the epicardium and implanting electrodes at this location has less impact on the heart. The implantation route from the epicardium at the apex of the heart into the ventricular myocardium can avoid excessive stimulation of the heart during the operation.

[0042] Preferably, the electrode enters the ventricular septum myocardium from the epicardium at the apex of the heart.

[0043] The ventricular myocardium generally includes the ventricular septum myocardium located between the left and right ventricles and the free wall myocardium located on the periphery of each ventricle. Generally, the apex corresponds to the position of the ventricular septum myocardium. It is convenient to enter the ventricular septum myocardium from the epicardium at the apex, and the electrode position can be closer to the terminal bifurcation of the His bundle, which can affect the heart rhythm from the upstream of the neural signal conduction.

[0044] Preferably, the electrode enters the ventricular myocardium from the epicardium at the ventricular free wall.

[0045] Preferably, the electrode enters the free wall myocardium from the epicardium at the ventricular free wall.

[0046] When the electrode needs to be implanted at the ventricular free wall, a shorter implantation path can be selected, and the epicardium can be punctured through the ventricular free wall near the electrical stimulation site.

[0047] Whether entering the epicardium through the apex or the ventricular free wall, it is important to avoid touching the His bundle and its downstream branches as much as possible to improve the safety of the implantation operation.

[0048] Preferably, it also includes a reference electrode that can be placed in the right atrium to collect electrocardiographic signals.

[0049] To facilitate ECG signal acquisition to guide the timing and intensity of electrical stimulation by the electrodes, ECG signals can also be acquired using a reference electrode. The method and path for placing the reference electrode in the right atrium are also described in the prior art. In the preferred embodiment of this application, the implantation path of the reference electrode is improved, and it can also use a similar implantation path as the electrodes, simplifying the operation steps.

[0050] Unless otherwise specified in the present application, the electrodes are electrodes used for applying electrical stimulation and located in the ventricular myocardium. The position of the electrodes is the position after implantation, i.e., in the working state.

[0051] Preferably, the reference electrode is wirelessly connected to a pulse generator that receives the signal collected by the reference electrode.

[0052] Preferably, the reference electrode is connected to a pulse generator that receives the signal collected by the reference electrode in a wired manner.

[0053] After the reference electrode is implanted, it can communicate with the pulse generator in a wired or wireless manner. In this application, whether it is the electrode or the reference electrode, when a wired method is used, the connection method and insulation method of the wires can adopt existing technologies; when a wireless method is used, the selected communication module and power supply settings can adopt existing technologies and are not the focus of improvement in this application.

[0054] Preferably, the reference electrode penetrates from the ventricular septum myocardium to the right atrium.

[0055] In order to simplify the operation steps, especially when the electrode is also located in the ventricular septal myocardium, the implantation of the reference electrode and the electrode can be completed through a one-time puncture operation. At least when switching the implantation object, the puncture sheath does not need to be completely withdrawn from the epicardium, avoiding the adverse effects of multiple punctures.

[0056] In the working state, the specific position of the electrode in the ventricular myocardium can be selected in multiple locations according to needs.

[0057] Preferably, the implantation site of the electrode is a predetermined electrical stimulation site, and the predetermined electrical stimulation site is located at at least one of the ventricular septum myocardium, the left ventricular free wall myocardium or the right ventricular free wall myocardium; one of the predetermined electrical stimulation sites is close to the terminal bifurcation of the His bundle, or one of the predetermined electrical stimulation sites is close to the left branch of the atrioventricular bundle or the right branch of the atrioventricular bundle.

[0058] Preferably, the electrode is located in the ventricular septum myocardium.

[0059] Preferably, the free wall myocardium is the left and / or right ventricular free wall myocardium.

[0060] Preferably, the electrodes are located in the ventricular septum myocardium and / or in the ventricular free wall myocardium.

[0061] When there is only one electrode, it can be located in the ventricular septum myocardium, the left ventricular free wall myocardium or the right ventricular free wall myocardium. When there are multiple electrodes, they can all be arranged in one of the above three locations, or distributed in two or three locations.

[0062] When the electrode is located within the ventricular septum, the specific location can be:

[0063] Preferably, one of the electrodes is close to the terminal bifurcation of the His bundle.

[0064] Preferably, one of the electrodes is close to the left branch of the atrioventricular bundle or the right branch of the atrioventricular bundle.

[0065] In order to ensure the effect of heart rhythm adjustment, in the preferred embodiment, the position of the electrode in the working state is close to the terminal bifurcation of the His bundle or the left branch of the atrioventricular bundle or the right branch of the atrioventricular bundle. When multiple electrodes are used, it can be understood that at least one electrode is in one of the above positions.

[0066] Preferably, the electrode is located at the midpoint between the apex and the terminal bifurcation of the His bundle in the direction of the long axis of the ventricular septum; or slightly adjacent to the terminal bifurcation of the His bundle; or slightly adjacent to the apex.

[0067] The left and right branches of the atrioventricular bundle meet at the terminal bifurcation of the His bundle. Within the ventricular septum, between the left and right branches of the atrioventricular bundle, lies a relatively sparsely nerved area where one or more electrodes can be implanted. Electrodes can generally be divided into one or more groups based on their lead extension and bundle splitting. Within a group, the leads of each electrode are bundled together, for example, by arranging all leads side by side or nested inside and outside, facilitating the simultaneous implantation of all electrodes in the same group.

[0068] Preferably, the electrodes in the ventricular septum myocardium are arranged in one group or two or more groups, and the groups are distributed at intervals along the short axis of the ventricular septum.

[0069] Preferably, there are one or more electrodes in the same group, and the electrodes are spaced apart and distributed along the long axis of the ventricular septum.

[0070] Preferably, the electrodes in the ventricular free wall myocardium are one or more groups, and each group is distributed at intervals along the circumference of the ventricular free wall.

[0071] Preferably, there are one or more electrodes in the same group, and the electrodes are spaced apart and distributed along the long axis of the ventricular free wall.

[0072] Since the ventricular septum is not a regular shape, the arrangement direction between different groups should be understood as a general trend. The long axis and short axis of the ventricular septum are relative to each other. The long axis of the ventricular septum is roughly parallel to the long axis of the ventricular free wall. In general, the longitudinal direction is often regarded as the long axis.

[0073] Preferably, the electrode located in the ventricular septal myocardium is a pacemaker electrode.

[0074] Preferably, the electrodes located in the ventricular free wall myocardium are pacemaker electrodes and / or defibrillator electrodes.

[0075] Preferably, there are one or more electrodes, and all electrodes have the same polarity, or two adjacent electrodes are used as a pair, and the polarities of the electrodes in the pair are opposite.

[0076] Preferably, the electrodes are arranged in one or more groups, each group having one or more electrodes, and the electrodes in the same group correspond to an arrangement path in the ventricular myocardium.

[0077] Preferably, the same arrangement path extends substantially along a straight line.

[0078] When there are a large number of electrodes, they can be divided into multiple groups according to their distribution positions or wire bundles. The spatial connection or extension trend of the electrodes in the same group during use can be regarded as the arrangement path. The arrangement path can be a virtual spatial position relationship, or, in the case of wires, the direction of the wires of the electrodes in the same group passing through the ventricular myocardium.

[0079] Preferably, each arrangement path is distributed radially within the ventricular myocardium with the apex as the center.

[0080] Preferably, the arrangement paths are parallel to each other in the ventricular myocardium.

[0081] Preferably, each arrangement path is arranged in the ventricular myocardium along the long axis of the heart.

[0082] In the present application, the pulse generator can be implanted in the body to generate electrical stimulation. The pulse generator itself is prior art, and the electrodes are electrically connected to the pulse generator through a separate arrangement or an integrated arrangement.

[0083] Preferably, the electrodes and the pulse generator are arranged separately, and the electrodes and the pulse generator communicate wirelessly.

[0084] Preferably, the electrode and the pulse generator are arranged separately, and the electrode has a smooth outer surface; or

[0085] The electrode and the pulse generator are integrated and have a smooth outer surface after integration.

[0086] The outer surface of the electrode mentioned above can be understood as the distal end and the outer peripheral surface of the electrode, and the proximal end of the electrode can also be connected to a wire.

[0087] The above-mentioned split arrangement means that the pulse generator can be connected to each electrode by wire or wirelessly. The pulse generator is generally implanted subcutaneously for easy portability. It can adopt the existing conventional implantation position or be adaptively adjusted according to the insertion direction of the electrode wire.

[0088] The integrated arrangement means that the electrode and the pulse generator are integrated into one, forming a closed capsule-shaped integrated electrode.

[0089] When the electrodes are arranged separately, they all have smooth outer surfaces to facilitate puncture and implantation into the ventricular myocardium. In addition, due to the structural characteristics of the ventricular myocardium, the smooth electrodes can be fixed without the use of existing spiral fixation structures.

[0090] Preferably, when the electrode and the pulse generator are integrated, a capsule-shaped integrated electrode is formed, wherein a battery unit for storing and stably releasing electrical energy and a control unit for receiving, processing, and feeding back signals are integrated. The integrated electrode has a smooth, closed housing.

[0091] Preferably, the pulse generator is located within the ventricular myocardium.

[0092] Most existing pulse generators are located under the skin. With the development of miniaturization, in a preferred solution, they can also be implanted into the ventricular myocardium along the electrode implantation path.

[0093] Preferably, the pulse generator and the electrode have the same implantation path.

[0094] Preferably, the periphery of the pulse generator is wrapped with a flexible buffer material.

[0095] In order to alleviate the unnecessary friction between the pulse generator and the ventricular muscle caused by heartbeat movement, a buffer material can be set on the periphery of the pulse generator. The buffer material can absorb the movement of the ventricular muscle, reduce direct friction with the pulse generator, and further improve safety. The buffer material can be made of medically acceptable materials and wrapped before the pulse generator is implanted, or applied to the periphery of the pulse generator by injection after the pulse generator is implanted.

[0096] Preferably, the pulse generator adopts a built-in or external power supply. The built-in power supply can save power lines and further improve the integration.

[0097] In this application, the puncture sheath is a tubular structure with an interior that serves as a channel for delivering the electrode. The electrode is releasably placed within the tube, and the distal end is formed into a pointed tip by beveling or other polishing methods to facilitate puncture and entry into the body. The puncture sheath is made of a metal material with a certain degree of elasticity and necessary strength, and its diameter can be set according to the puncture target and the size of the electrode.

[0098] Preferably, the length of the tube is 12 to 20 cm.

[0099] Since it is necessary to enter the ventricular myocardium from outside the body, the tube body should have a sufficient length, which is also compatible and coordinated with the improvement of the electrode implantation path of the present application.

[0100] Preferably, a bending wire is movably provided in the tube body, the distal end of the bending wire is connected to the inner wall of the puncture head, and the proximal end of the bending wire extends out of the tube body as a force-applying end for pulling the puncture head to change its direction.

[0101] After the tube enters the body, especially after entering the ventricular myocardium, the angle of advancement may need to be changed during the puncture process. Since the tube itself is slender and elastic, pulling the bending wire at the proximal end can change the direction of the puncture head. The distal end of the bending wire can be fixed to the inner wall of the puncture head by welding or using a connector. The bending wire is made of a relatively thin and strong metal wire to avoid spatial interference with the electrodes and wires in the tube as much as possible.

[0102] Preferably, a fixed handle is provided, in which a transition cavity is provided. The proximal end of the tube body is sealed and inserted into the fixed handle, and the inner cavity of the tube body is connected to the transition cavity. An electrode input port connected to the transition cavity is provided on the fixed handle, and the proximal end of the bending wire extends out of the fixed handle.

[0103] The provision of a transition cavity can separate the guide wire and the bending wire at the proximal end to avoid mutual influence during operation.

[0104] Preferably, a branch pipe communicating with the transition cavity is provided on the side wall of the fixed handle, and the bending adjustment wire extends out of the fixed handle from the branch pipe.

[0105] Leading the bending wire out from the branch pipe on the side wall of the fixed handle makes it easier to push the electrode and the wire along the axial direction of the tube body.

[0106] Preferably, the cardiac rhythm adjustment system further comprises a guiding device, which comprises a base fixable on the body surface and an adapter seat mounted on the base with an adjustable position, and the puncture sheath is assembled on the adapter seat.

[0107] In the present application, the puncture sheath can be adjusted with the aid of a guiding device, which can be, for example, a manipulator movable in three dimensions, an adjusting bracket, etc. Different positions of the puncture sheath also correspond to different postures of the guiding device, which can be adjusted and controlled automatically or manually.

[0108] The guiding device of the present application comprises a base fixed to the body surface and an adaptor seat mounted on the base with adjustable position, wherein the puncture sheath is assembled to the adaptor seat. The guiding device is used to position the puncture sheath for puncture and maintain various working states, wherein the working state refers to the puncture state in which the puncture sheath moves relative to the guiding device.

[0109] Preferably, the guiding device is further used to keep the puncture sheath in various working states within the hemispherical space during the puncture process.

[0110] When the guiding device remains stationary as a whole, the puncture sheath can move within a certain plane relative to the guiding device, and the angle between the two extreme positions of the movement range is 180 degrees.

[0111] If the movement of the guiding device itself or at least the movement of the portion that carries the puncture sheath is taken into account, the puncture sheath can move within the hemispherical space.

[0112] Preferably, an arc-shaped guide rail is fixed on the base, the adapter seat is slidably positioned on the arc-shaped guide rail, and the puncture sheath is movably positioned and passed through the adapter seat.

[0113] Preferably, the arc-shaped guide rail defines a first plane, the bending wire pulls the puncture sheath to bend in a second plane at the distal end, and the first plane is perpendicular to the second plane.

[0114] Preferably, a fixed handle is provided at one end of the puncture sheath away from the puncture head, and the fixed handle cooperates with the guiding device.

[0115] Preferably, the tube body is provided with a scale indicating the relative position with respect to the guiding device.

[0116] Preferably, an imaging system is provided to guide puncture of the puncture sheath and to display the position of the electrode.

[0117] Preferably, the guiding device is provided with an ultrasonic probe, which transmits the real-time collected electrode position or distal posture of the puncture sheath to the imaging system. The imaging system is at least one of ultrasound, CT, and MRI, which is itself an existing technology and is used to monitor the puncture site during surgery and display the position of the puncture sheath and the electrode. The imaging system can collect and process data and display images. The sensing elements set inside and outside the patient's body to collect corresponding position state parameters can be connected to the imaging device as a detection unit. When the image is output through the display unit, the information collected by the sensing elements is added, which is more instructive.

[0118] Preferably, a simulation navigation system is provided to indicate the electrical stimulation position and the relative position of the electrodes in real time. The simulation navigation system may be one or more of magnetic navigation, infrared navigation, and optical navigation.

[0119] Preferably, the simulation navigation system pre-models the heart in three dimensions. When in use, the simulation navigation system uses an imaging system to collect electrode positions in real time and displays them on the corresponding locations of the heart model for comparison with the predetermined electrical stimulation positions. Basic heart data can be collected in advance, including four heart damage data (troponin I (TropI), myoglobin (Mb), creatine kinase isoenzyme mass (CK-MBmass), B-type pro-brain natriuretic peptide), heart rhythm, conventional and 24-hour dynamic electrocardiograms, echocardiograms, ventricular wall thickness, the location and extent of myocardial fibers, coronary artery shape, etc., to perform a three-dimensional reconstruction of the patient's heart to obtain a heart model. Furthermore, the needle position is collected and displayed in real time on the heart model for real-time monitoring and guidance. Basic data can be collected based on one or more of three-dimensional ultrasound, CT, or MRI, followed by three-dimensional heart modeling to display the structure of the heart, especially the ventricular septum, ventricular free wall, endocardium, and other relevant parts. In vitro experiments, animal experiments, and clinical records can be integrated to calculate the electrical stimulation position and plan the corresponding implantation path.

[0120] Preferably, a pushing device is slidably provided in the tube body, and the distal end of the pushing device can push the electrode to release the tube body.

[0121] During the release of the electrode, an appropriate pushing force needs to be applied to ensure that the electrode is completely implanted into the ventricular myocardium. Therefore, the cardiac rhythm adjustment system of the present application introduces a pushing device to facilitate pushing the electrode into the ventricular myocardium.

[0122] Preferably, the pushing device is tubular and has a guide channel inside. The electrode is connected to a connecting wire, and the connecting wire extends toward the proximal end through the guide channel.

[0123] In the present application, when faced with different scenarios of implanting one or more electrodes, the internal structure of the puncture sheath body is also improved accordingly to better adapt to different scenarios.

[0124] For example, the interior of the puncture sheath can be a single-lumen or multi-lumen structure, and electrodes can be arranged independently in each cavity, and can also serve as an extension channel for other components such as electrode wires, traction wires, and pushing devices.

[0125] Preferably, the tube body is a single-lumen tube, and the electrode is one or a plurality of electrodes arranged in sequence along the length direction of the tube body.

[0126] The tube body of multiple cavities can be provided with a variety of partition structures. For example, a partition can be provided in the tube body to divide the tube body into two cavities, or a plurality of independent auxiliary cavities can be provided in the tube body.

[0127] Preferably, the interior of the tube body includes a first cavity and a second cavity, the two cavities extend side by side from the distal end to the proximal end, and a plurality of electrodes are arranged along the length direction in the first cavity; there is a partition between the two cavities, and the partition is provided with a plurality of avoidance holes. For each electrode, there is at least one avoidance hole on the proximal side of the electrode, and each electrode is connected to a connecting line, and each connecting line extends from the avoidance hole to the second cavity, and extends from the second cavity out of the proximal end of the tube body.

[0128] Preferably, a damping structure interacting with each other is provided between the first cavity and each electrode to prevent displacement of the electrodes during puncture. The damping structure may be a raised point on the inner wall of the tube body that can retain the electrodes, or it may be an interference fit between the tube body and the electrodes to generate damping. Similar structures are not listed here.

[0129] Preferably, the second cavity is equipped with a pushing device, which is tubular and used to receive the connecting line.

[0130] Preferably, the pushing device can enter the first cavity along the connecting line through the corresponding avoidance hole and push the corresponding electrode.

[0131] The interior of the pushing device is a threading channel, and the connecting wire connected to the proximal end of the electrode extends toward the proximal end through the threading channel.

[0132] Preferably, a plurality of cavities are arranged side by side inside the tube, and each electrode is disposed in a corresponding cavity;

[0133] A pushing device is slidably provided in the tube body, and the distal end of the pushing device can push the electrode to release the tube body.

[0134] Preferably, the pushing device is a set and can be switched to each cavity, or the pushing device is a plurality of sets and is arranged in a corresponding cavity.

[0135] Preferably, the plurality of electrodes are staggered along the length direction of the tube body.

[0136] In this preferred embodiment, the pushing device may be in the shape of a tube having an internal through-channel. When the pushing device is switched to one of the cavities, the connection line of the corresponding electrode in the cavity extends toward the proximal end through the through-channel.

[0137] In the preferred embodiment of the multi-cavity structure, the electrode and the pulse generator can be arranged separately, and the electrode has a smooth outer surface; or the electrode and the pulse generator can be arranged in an integrated manner (i.e., forming an integrated electrode), and have a smooth outer surface after integration.

[0138] Preferably, the integrated electrode or electrode has a relative proximal end, a distal end and an outer peripheral surface extending from the distal end and the proximal end, the distal end and the outer peripheral surface are smooth, and the proximal end is provided with a first binding site for removable connection with the connecting wire.

[0139] Preferably, the first binding position may be a threading hole for the connecting wire to pass through.

[0140] The electrodes or integrated electrodes mentioned above are removably connected to the connecting wires. This means that the electrodes are provided with threading holes, through which the connecting wires are passed to connect the electrodes to the pusher. Once the electrodes are implanted, the connecting wires can be cut to remove them from the electrodes.

[0141] The present application also provides a heart rhythm adjustment method, wherein electrodes are implanted into predetermined electrical stimulation sites within the ventricular myocardium, and electrical stimulation is performed accordingly.

[0142] Preferably, when implanting the electrode, the puncture sheath is first used to puncture the body surface and the epicardium in sequence to reach the electrical stimulation site in the ventricular myocardium, and then the electrode is transported to the electrical stimulation site through the inner lumen of the puncture sheath.

[0143] Preferably, when the electrode is implanted at a predetermined electrical stimulation site in the ventricular myocardium, the method comprises:

[0144] Planning the implantation route;

[0145] A puncture sheath pre-installed with an electrode is provided, and the puncture sheath is inserted along the implantation path through the epicardial puncture approach until the distal end of the puncture sheath reaches the predetermined electrical stimulation position; the electrode is separated from the puncture sheath and maintained at the predetermined electrical stimulation position under the covering of the surrounding tissue.

[0146] Preferably, the planned implantation path includes:

[0147] Collect basic heart data;

[0148] Performing three-dimensional modeling of the heart to obtain a heart model; acquiring data based on one or more of three-dimensional ultrasound, CT, or MRI, and displaying the structures of the ventricular septum, ventricular free wall, and endocardium in the heart model;

[0149] Calculate the electrical stimulation site and plan the corresponding implantation path.

[0150] Preferably, when the puncture sheath is implanted along the epicardial puncture path, the real-time position of the puncture sheath is acquired, and the position of the puncture sheath is displayed in real time in the heart model through calculation and simulation. Preferably, a removable connecting wire is pre-connected to the proximal end of the electrode.

[0151] Preferably, when the electrode is separated from the puncture sheath, it is pushed toward the distal end along the connecting line of the electrode until the electrode is pushed out of the tube body.

[0152] Preferably, a pushing device is slidably provided in the puncture sheath, and the distal end of the pushing device can push the electrode to release the tube body.

[0153] Preferably, a first cavity and a second cavity are formed in the puncture sheath by a partition, a pushing device with a guide channel therein is slidably provided in the second cavity, a plurality of electrodes are arranged along the length direction of the first cavity, a plurality of avoidance holes are arranged in the partition, and a connecting wire is connected to the proximal end of each electrode and the connecting wire extends from the avoidance hole to the guide channel and extends out of the proximal end of the tube body, so that when the electrode is separated from the puncture sheath, it includes:

[0154] S100: The distal end of the puncture sheath reaches the most distal electrical stimulation position, and the pushing device is pushed distally along the connection line of the most distal electrode. The pushing device enters the first cavity through the corresponding avoidance hole and continues to push distally until the most distal electrode is pushed out of the puncture sheath;

[0155] S200: The puncture sheath is retracted proximally to the sub-distal electrical stimulation site, and then pushed distally along the connecting line of the sub-distal electrode. The pushing device enters the first cavity through the corresponding avoidance hole and continues to push distally until the sub-distal electrode is pushed out of the puncture sheath.

[0156] This process is repeated in this way until all electrodes are pushed out of the puncture sheath. Beneficial effects

[0157] The electrodes in this application are implanted via an intramyocardial pathway and, through pulse generator programming, achieve true physiological position pacing and biventricular electrical synchronization. Although the mechanisms of malignant ventricular arrhythmias vary, the substrate that causes malignant ventricular arrhythmias is often located in a fixed position, making it easy for intramyocardial pacing electrodes to reach this location. This can be achieved through local rapid pacing inhibition or low-energy defibrillation to suppress malignant ventricular arrhythmias. BRIEF DESCRIPTION OF THE DRAWINGS

[0158] FIG1 is a schematic diagram of electrode implantation positions in one embodiment of the present application;

[0159] FIG1a is a schematic diagram of the electrode puncture implantation process in FIG1 ;

[0160] FIG2 is a schematic diagram of electrode implantation positions in one embodiment;

[0161] FIG3 is a schematic diagram of electrode implantation positions in one embodiment;

[0162] FIG4 is a schematic diagram of electrode implantation positions in one embodiment;

[0163] 4a to 4d are schematic diagrams of the electrode puncture and implantation process in FIG4 ;

[0164] [Corrected 10.10.2024 according to Rule 91] Figure 4e is a schematic diagram of the puncture and implantation process of each electrode in one embodiment; [0164.1] [Corrected 10.10.2024 according to Rule 91] Figure 4f is a schematic diagram of the structure of electrodes in one embodiment;

[0165] FIG5 is a schematic diagram of electrode implantation positions in one embodiment;

[0166] FIG6 is a schematic diagram of another angle of the electrode implantation position in FIG5;

[0167] FIG7 is a schematic diagram of electrode implantation positions in one embodiment;

[0168] FIG8 is a schematic diagram of electrode implantation positions in one embodiment;

[0169] FIG9 is a schematic diagram of a reference electrode implantation position in one embodiment;

[0170] FIG10 is a schematic diagram of the implantation position of a pulse generator in one embodiment;

[0171] FIG11 is a schematic structural diagram of a puncture sheath;

[0172] FIG12 is a schematic structural diagram of a fixed handle of a puncture sheath;

[0173] FIG13 is a schematic diagram of the connection portion of the bending wire in the puncture sheath;

[0174] FIG14 is a schematic diagram of the change in position of the puncture sheath;

[0175] FIG15 is a schematic diagram of an imaging system;

[0176] FIG16 is a schematic diagram of a guiding device;

[0177] 17 to 19 are schematic diagrams of different connection methods of electrodes and pulse generators in this application;

[0178] [Corrected 10.10.2024 according to Rule 91] Figures 20 and 21 are schematic diagrams of different electrode structures in this application;

[0179] [Corrected 10.10.2024 according to Rule 91] FIG22 is a schematic diagram of the path for inserting an electrode into the left ventricle via the inferior venous vein in one embodiment of the present application; [0179.1][Corrected 10.10.2024 according to Rule 91] Figure 23 is a schematic diagram of the path for inserting electrodes into the right ventricle via the systemic vein in one embodiment of the present application.

[0180] The reference numerals in the figures are described as follows:

[0181] 1. Left ventricle; 11. Right atrium; 2. Right ventricle; 3. Interventricular septum; 4. Apex; 5. Epicardium; 6. Endocardium; 7. Ventricular free wall; 8. Bundle of His; 9. Right branch of the atrioventricular bundle; 10. Left branch of the atrioventricular bundle; 12. Body; 121. First cavity; 122. Second cavity; 123. Separator; 124. Avoidance hole; 124a. Avoidance hole; 13. Puncture tip; 14. Fixed handle; 16. End cap; 17. Branch tube; 18. Transition cavity; 19. Adjustment wire; 20 , puncture sheath; 21, guide wire; 30, guide device; 31, adapter; 32, base; 33, ultrasound probe; 40, imaging system; 50, pushing device; 51, pushing tube; 52, threading channel; 53, threading hole; 54, connecting line; 60, electrode; 601, anchor; 602, support body; 61, electrode; 62, electrode; 63, electrode; 64, electrode; 65, electrode; 66, electrode; 70, reference electrode; 80, pulse generator; 90, body surface. Modes for Carrying Out the Invention

[0182] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0183] It should be noted that when a component is referred to as being "connected" to another component, it may be directly connected to the other component or there may be an intermediate component. When a component is referred to as being "disposed on" another component, it may be directly disposed on the other component or there may be an intermediate component.

[0184] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this application pertains. The terms used herein in the specification of this application are for the purpose of describing specific embodiments only and are not intended to limit this application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0185] An embodiment of the present application provides a cardiac rhythm adjustment system and a cardiac rhythm adjustment method. When the specific method adopts transepicardial electrode implantation, it can also be understood as providing a transepicardial electrode implantation method. The relevant components in the cardiac rhythm adjustment system can also be combined with the relevant description of the implant delivery system (delivery system) below.

[0186] Refer to Figure 1, which shows the internal structure of the heart, in which the ventricular septum 3 is located between the left ventricle 1 and the right ventricle 2, the right atrium 11 is above the right ventricle 2, the inside and outside of the ventricular myocardium are the epicardium 5 and the endocardium 6 respectively, the bottom of the heart in the figure is the apex 4, the ventricular myocardium includes the ventricular septum 3 (ventricular septum myocardium) and the ventricular free wall 7 (free wall myocardium), and a conduction bundle extends in the ventricular myocardium (indicated by the dotted line), specifically including the His bundle 8, the end of the His bundle 8 is bifurcated into two branches, namely the left branch of the atrioventricular bundle 10 and the right branch of the atrioventricular bundle 9.

[0187] In order to regulate the heart rhythm, an electrode 60 is implanted at a position slightly close to the apex 4 of the ventricular septum 3. The implantation path L of the electrode 60 enters the ventricular myocardium through the body surface 90 and the apex 4. When the electrode is connected by wire, the part of the implantation path L in the ventricular myocardium can also be regarded as the extension direction of the wire. The internal structure of the electrode 60 has been described in the prior art.

[0188] In this embodiment, an electrode 60 is implanted. Electrode 60 can be located not only at the position shown in FIG1 , within the ventricular septum 3 and away from the His bundle 8, but also in other embodiments, within the ventricular septum 3 and near the terminal bifurcation of the His bundle 8, or within the ventricular free wall 7. However, in all cases, the electrode 60 is at least located within the ventricular myocardium between the epicardium 5 and the endocardium 6. The electrode 60 located within the ventricular septum can be a pacemaker electrode. The electrode 60 located within the ventricular free wall can be a pacemaker electrode and / or a defibrillator electrode.

[0189] During the implantation process of the electrode 60 , the operator implants the electrode 60 into the predetermined electrical stimulation site through the coordination of the guiding device, the puncture sheath, the pushing device, and the imaging system.

[0190] This embodiment also provides a method for implanting an implantable electrode:

[0191] S100: Through epicardial puncture (in some other embodiments below, a method of implanting electrodes via other interventional pathways is also provided) the delivery system reaches a predetermined first implantation position (electrical stimulation site) along the implantation pathway.

[0192] S101: releasing a first implanted electrode to a first implantation position;

[0193] S102: Retract the conveying system.

[0194] The implantation method of this embodiment further includes, before step S100, providing a puncture sheath pre-installed with electrodes: pre-installing the electrodes into the puncture sheath, and passing a connecting wire connected to the electrodes through the catheter body.

[0195] The above implantation method further includes, before the implantation step S100, planning the implantation path using an imaging system, specifically including:

[0196] Collect basic heart data: such as heart chamber size, heart long axis, short axis, etc.;

[0197] Perform three-dimensional cardiac modeling to obtain a cardiac model; based on one or more of three-dimensional ultrasound, CT, or MRI, the structures of the ventricular septum, ventricular free wall, and endocardium are displayed in the cardiac model;

[0198] Calculate the electrical stimulation site and plan the corresponding implantation path.

[0199] As shown in Figure 1a, the puncture sheath is inserted into the epicardium along the planned implantation path. The puncture sheath's puncture path is positioned on the planned implantation path L, and the sheath is maintained in a state of extending and puncturing along the implantation path L. When the puncture sheath is inserted into the epicardium along the implantation path, the real-time position of the puncture sheath can be acquired using an ultrasound probe or the like, and the position of the puncture sheath can be displayed in real time on the heart model through calculation and simulation.

[0200] When the implanted electrode and the pulse generator are separated and communicate with the pulse generator by wire, the above-mentioned implantation method also includes, after the implantation step S102, connecting the wire connected to the electrode with the pulse generator and implanting the pulse generator under the human skin.

[0201] When the implanted electrode and the pulse generator adopt separate wireless communication, the above implantation method further includes, after the implantation step S102, implanting the pulse generator subcutaneously in the human body.

[0202] When the implanted electrode is integrated with the pulse generator, in step S101, a removable connecting wire can be pre-connected to the proximal end of the electrode so that when the electrode is detached from the puncture sheath, it is pushed toward the distal end along the connecting wire of the electrode until the electrode is pushed out of the tube body.

[0203] The implantation method further includes, after the implantation step S101, withdrawing the delivery system to a second implantation location and releasing the second electrode at the second implantation location. After the second electrode is implanted, a third electrode may be released at a third implantation location according to the actual case.

[0204] In one embodiment, the delivery system is pre-installed with an implantable electrode. When one electrode is implanted, a second implantable electrode is loaded into the delivery tube. The following is a specific implementation method:

[0205] The electrode 60 can be releasably placed in the tube body of the puncture sheath, and the inner wall of the tube body can be provided with a damping structure, for example, a protrusion for limiting the sliding of the electrode 60.

[0206] The pushing device is a hollow pushing tube with a certain strength. The distal end of the pushing tube can also be releasably connected to the electrode 60. For example, a connecting line is fixed at the distal end of the pushing tube, and the proximal end of the connecting line passes through the electrode binding position and extends out of the proximal end of the pushing tube.

[0207] Specific operations include:

[0208] 1. Releasably connect the electrode 60 to the distal end of the push tube 51 via a connecting wire, with the electrode 60 embedded in the tube body and the proximal end of the push tube 51 extending out of the proximal end of the tube body;

[0209] 2. Through the guiding device 30, the puncture head 13 of the puncture sheath 20 directly reaches the electrical stimulation site along the implantation path L;

[0210] 3. The push tube 51 pushes the electrode 60 to the predetermined electrical stimulation position;

[0211] 4. Use imaging system to determine whether the release position is as expected;

[0212] 5. While maintaining the position between the electrode 60 and the push tube 51, remove the connecting wire. After the connecting wire is completely removed, simultaneously remove the puncture sheath 20 and the push tube 51 from the body surface.

[0213] The implantation positions of the multiple electrodes are described in detail below.

[0214] 2 , in this embodiment, at least two electrodes are implanted in the myocardium to regulate heart rhythm. Electrode 61 is implanted in the ventricular septum 3 near the terminal bifurcation of the His bundle 8 . The implantation path L1 of electrode 61 is from the body surface through the apex 4 into the ventricular septum 3 .

[0215] In addition, electrodes 62 and 63 are implanted in the ventricular free wall 7, respectively. Electrodes 62 and 63 correspond to implantation paths L2 and L3, respectively. Implantation paths L2 and L3 enter the ventricular free wall 7 on the corresponding side from the body surface and the apex 4. Paths L1, L2, and L3 enter the myocardium through the same puncture point.

[0216] In the case of wired connection, the portion of each implanted pathway within the ventricular myocardium can also be considered as the extension direction of the wire.

[0217] Each implantation path is located between the epicardium 5 and the endocardium 6 in the ventricular myocardium, and tries to avoid puncturing the conduction bundle. When switching different implantation paths during the implantation operation, the puncture sheath can always remain in the apex, and directly change its direction to switch the implantation path after withdrawing to the vicinity of the apex.

[0218] As one embodiment of the present application, different implantation pathways can also be used to enter the myocardium through different puncture points. Referring to FIG3 , in this embodiment, to regulate heart rhythm, an electrode 61 is implanted in the ventricular septum 3 near the terminal bifurcation of the His bundle 8. The implantation pathway L1 of electrode 61 is from the body surface and the cardiac apex 4 into the ventricular septum 3.

[0219] In addition, an electrode 62 is implanted in the ventricular free wall 7 . The electrode 62 corresponds to an implantation path L2 . The implantation path L2 sequentially enters the ventricular free wall 7 from the body surface and the epicardium at the ventricular free wall 7 .

[0220] As an embodiment of the present application, multiple electrodes can also be implanted along the same implantation pathway. Referring to Figure 4 , in this embodiment, electrode 61 is implanted in the ventricular septum 3 near the terminal bifurcation of the His bundle 8 to regulate cardiac rhythm. Electrode 63 is also implanted in the middle of the long axis of the ventricular septum 3 near the right branch of the atrioventricular bundle 9. Electrode 62 is also implanted in the ventricular septum 3 near the apex of the heart near the left branch of the atrioventricular bundle 10. In this embodiment, the electrodes are arranged in a generally linear arrangement and can be implanted along the same implantation pathway L4, for example, from the body surface and the apex 4 into the ventricular septum 3.

[0221] Referring to Figures 3 to 4, 4a to 4d, when the puncture sheath needs to implant multiple electrodes along one or more implantation paths, the interior of the tube body 12 includes a first cavity 121 and a second cavity 122. The two cavities extend side by side from the distal end to the proximal end, with a partition 123 between the two cavities, and multiple electrodes are arranged along the length direction in the first cavity.

[0222] The partition is arranged with multiple avoidance holes 124. For each electrode, there is at least one avoidance hole on the proximal side of the electrode. Each electrode is removably connected with a connecting wire 54, and each connecting wire extends through the avoidance hole to the second cavity and extends from the second cavity to the proximal end of the tube body.

[0223] When the puncture tip of the puncture sheath reaches the electrical stimulation site, a pushing device 50 is installed in the second cavity to push the electrode into the second cavity. The pushing device is a hollow tubular structure, such as the push tube 51 shown in the figure. The push tube contains a connecting wire threading channel 52. The pushing device can enter the first cavity along the connecting wire through the corresponding avoidance hole and push the corresponding electrode.

[0224] The specific implantation process of multiple electrodes is explained below.

[0225] In another embodiment, multiple electrodes are pre-installed simultaneously within the delivery system.

[0226] 4a to 4d, the guiding device 30 positions the puncture point and puncture angle of the puncture sheath. A plurality of electrodes are arranged along the length direction in the first cavity 121 of the puncture sheath: electrode 61, electrode 63 and electrode 62. The plurality of electrodes correspond to the predetermined implantation positions in sequence. A damping structure is provided between the first cavity and each electrode to prevent the electrodes from moving and misaligning during the puncture process.

[0227] Each electrode is pre-removably connected to a connecting wire 54. Each connecting wire extends from the avoidance hole closest to the proximal end of the corresponding electrode to the second cavity, and then extends from the second cavity to the proximal end of the tube body. As shown in Figures 4c and 4d, the connecting wire of electrode 61 extends from avoidance hole 124a to the second cavity, and the same applies to the other electrodes.

[0228] The pushing device 50 is assembled in the second cavity and can at least push the corresponding electrode along the connecting line through the corresponding avoidance hole. The pushing device is a pushing tube that slides with the connecting line, and the distal end of the pushing tube pushes the electrode.

[0229] The more specific implantation process of multiple electrodes is as follows:

[0230] S100: Puncture the epicardium to reach the predetermined implantation position (the puncture sheath reaches the most distal electrical stimulation position), push the pushing device distally along the connection line of the most distal electrode, and enter the first cavity through the corresponding avoidance hole. Continue to push distally until the most distal electrode is pushed out of the puncture sheath;

[0231] S200: The puncture sheath is retracted proximally to the sub-distal electrical stimulation site, and then pushed distally along the connecting line of the sub-distal electrode. The pushing device enters the first cavity through the corresponding avoidance hole and continues to push distally until the sub-distal electrode is pushed out of the puncture sheath.

[0232] The process is analogous to that described above, until all electrodes are pushed out of the puncture sheath, and finally the puncture sheath and the pushing device are withdrawn.

[0233] In another embodiment, as shown in Figure 4e, during the implantation of multiple electrodes, the tube body can also be configured with multiple cavities arranged side by side, with each electrode configured in a corresponding cavity. A pushing device is slidably provided within the tube body, and the distal end of the pushing device can push the electrode out of the tube body. The pushing device can be provided as a single set and can be switched between cavities, or multiple sets of pushing devices can be provided and arranged in corresponding cavities. The multiple electrodes can be staggered along the length of the tube body.

[0234] In another embodiment, as shown in FIG4f , multiple electrodes 60 can be located on a single support 602 . The support 602 is made of an acceptable biocompatible material and insulates the electrodes 60 from one another. The electrodes 60 are annular and fixed around the periphery of the support 602 . Two or three electrodes 60 can be arranged at intervals and implanted along with the support 602 . The end of the support 602 can be provided with a spirally coiled, convergent anchor 601 for screwing into the surrounding tissue and maintaining a predetermined position. The anchor 601 can be made of metal and can also be connected to a circuit and used as an electrode.

[0235] Of course, in other embodiments, one, two or more electrodes can be implanted according to the patient's symptoms. Multiple electrode implants can be implanted through the same puncture point and multiple implantation pathways, or through different puncture points and multiple implantation pathways.

[0236] 5 and 6 , in this embodiment, multiple electrodes A are implanted in the ventricular septum 3 to regulate heart rhythm. The multiple electrodes are divided into three groups, and the groups are arranged along the short axis X direction of the ventricular septum 3 . The three electrodes in the same group are arranged along the long axis Y direction of the ventricular septum 3 .

[0237] For example, electrodes 61, 62 and 63 are arranged as a group along the long axis Y direction of the ventricular septum 3, and the three electrodes in the adjacent group are electrodes 64, 65 and 66, which are also arranged along the long axis Y direction of the ventricular septum 3.

[0238] All three groups of electrodes can be implanted through apex 4 puncture. In this embodiment, each group of electrodes is roughly arranged in a straight line. Of course, in other embodiments, the number of groups and the number of electrodes in each group can also be adjusted according to needs and the characteristics of the lesion site. For example, it can be set to two or four groups, each group has two or four electrodes, and the number of electrodes in each group can be the same or different. For example, in this embodiment, the number of electrodes in the three groups can be one, two, or three respectively; or the number of electrodes in the three groups can be two, two, or three respectively, and so on.

[0239] As an embodiment of the present application, referring to FIG7 , relative to the embodiment shown in FIG5 , in this embodiment, the groups of electrodes in the ventricular septum 3 are arranged roughly in a straight line, and the three groups of electrodes are roughly radially distributed around the apex 4 , that is, they enter the ventricular septum along the same puncture point.

[0240] The middle group of electrodes is arranged along the long axis Y of the ventricular septum 3, and the groups on both sides are arranged obliquely relative to the long axis Y of the ventricular septum 3. For example, the arrangement path of electrodes 61, 62, and 63 in the left group has a certain angle with the long axis Y of the ventricular septum 3, for example, the angle can be 15 degrees to 60 degrees. As an embodiment of the present application, referring to Figure 8, in this embodiment, multiple electrodes are implanted in the ventricular free wall 7 to regulate the heart rhythm. This embodiment can also be combined with other embodiments, that is, on the basis of implanting electrodes in the ventricular septum, further electrodes are arranged in the ventricular free wall 7. Of course, electrodes can also be implanted only in the ventricular free wall 7.

[0241] Multiple electrodes are divided into two groups and are all located between the epicardium 5 and the endocardium 6. For example, electrode 61, electrode 62 and electrode 63 are arranged as a group along the long axis Y direction of the ventricular septum 3, and the three electrodes in the adjacent group are electrode 64, electrode 65 and electrode 66, and electrode 64, electrode 65 and electrode 66 are also arranged along the long axis Y direction of the ventricular septum 3.

[0242] The electrodes of the two groups are distributed circumferentially in the Z direction around the ventricular free wall 7. The implantation path of each group of electrodes can be based on the implantation path of the electrodes in the ventricular free wall 7 in the embodiment shown in FIG2 or FIG3.

[0243] In other embodiments, the number of reference electrodes may be increased as needed and implanted in corresponding positions.

[0244] Referring to FIG. 9 , in this embodiment, a reference electrode 70 is implanted in the right atrium 11 to obtain an electrocardiogram (ECG) signal as a reference for rhythm regulation. The implantation method and placement of the rhythm regulation electrode can be combined with other embodiments. In this embodiment, the reference electrode 70 is implanted along a path L extending from the body surface through the apex 4 and the ventricular septum 3 into the right atrium 11. The reference electrode 70 and the rhythm regulation electrode can be anchored using existing techniques, such as active or passive methods.

[0245] Referring to Figure 10, in order to drive the electrodes, a corresponding pulse generator must be matched. Most existing pulse generators are implanted subcutaneously. This application also provides an implementation method of implanting the pulse generator 80 in the ventricular myocardium. The implantation path of the pulse generator 80 is through the body surface and then through the apex 4 and into the interventricular septum. The position of the pulse generator 80 in the interventricular septum is preferably located at the apex where the conduction bundles are relatively sparse. In a preferred embodiment, the periphery of the pulse generator 80 is wrapped with a flexible cushioning material. The cushioning material can absorb the movement of the ventricular myocardium, reduce direct friction with the pulse generator, and further improve safety. The cushioning material can be made of medically acceptable materials and wrapped before the pulse generator is implanted, or applied to the periphery of the pulse generator by injection after the pulse generator is implanted. The pulse generator 80 uses a built-in or external power supply. The built-in power supply can eliminate the power cord and further improve the integration.

[0246] 11 to 13 , in order to facilitate the implantation operation, the puncture sheath includes a hollow tubular body 12 , the distal end of the tubular body 12 is a puncture head 13 that can penetrate the ventricular myocardium and guide the tubular body 12 to pass through the ventricular myocardium, and the proximal end of the tubular body 12 is a fixed handle 14 .

[0247] The puncture sheath is a tubular structure with an interior that serves as a channel for the electrode. The distal end is sharpened by beveling or other polishing methods to facilitate puncture and entry into the body. The puncture sheath is made of a metal material with a certain degree of elasticity and necessary strength, and its diameter can be customized according to the puncture target and electrode size.

[0248] The length of the tube 12 can be at least 12 to 20 cm, for example, extending from the outside of the body through the apex of the heart to the inside of the ventricular myocardium.

[0249] A transition chamber 18 is provided within the fixed handle 14, into which the tube body 12 is docked. A branch pipe 17 is provided on the sidewall of the fixed handle 14, communicating with the transition chamber 18. A plug 16 is threadedly mounted on the proximal end of the fixed handle 14, and the plug 16 has a through-hole communicating with the transition chamber 18. A connecting wire 21, or conductor, connected to the electrode can extend through the through-hole and out of the proximal end of the fixed handle 14.

[0250] During implantation, in order to adjust the implantation path, the delivery system also includes a bending adjustment device, which can be a bending adjustment wire. For example, as shown in FIG13 , a bending adjustment wire 19 is movably inserted into the tube body 12. The bending adjustment wire 19 is made of a relatively thin metal wire with sufficient strength. The distal end of the bending adjustment wire 19 is welded and fixed to the inner wall of the puncture head 13. The proximal end of the bending adjustment wire 19 extends from the fixed handle 14 as a force-applying end for pulling the puncture head 13 to change its direction (as shown in FIG13 ). The proximal end of the bending adjustment wire 19 extends from the branch tube 17 to the side wall of the fixed handle 14; or the connecting wire 21 connected to the electrode can extend from the branch tube 17 to the side wall of the fixed handle 14, and the bending adjustment wire 19 extends from the lead hole to the proximal end of the fixed handle 14 (as shown in FIG12 ).

[0251] The conductive wire 21 and the bending wire 19 are separated to avoid mutual influence during operation and to facilitate the axial pushing of the electrode and the connecting wire along the tube body 12 .

[0252] The present application provides an implant delivery system comprising a puncture sheath and an implant. The puncture sheath comprises a hollow tubular body, into which an implant is releasably placed. The distal end of the tubular body is a puncture tip that can penetrate the ventricular myocardium and guide the tubular body within the ventricular myocardium. The tubular body is at least long enough to extend from the outside of the body through the apex to the inside of the ventricular myocardium. The implant may comprise a hydrogel, a therapeutic drug, an electrode, or the like. The implant delivery system of the present application is suitable for implantation via an intramyocardial route, reducing operational difficulty.

[0253] Referring to Figures 14 to 16, in one embodiment, in order to achieve precise positioning during implantation, the implant delivery system further includes a guiding device 30, which is used to position the puncture sheath 20 for puncture and maintain various working states. The guiding device 30 can be, for example, a manipulator that can move in three-dimensional space, an adjustment bracket, or the like. For example, the guiding device 30 includes a base 32 that can be fixed to the body surface 90 and an adapter seat 31 that is adjustable in position and mounted on the base 32. The puncture sheath 20 is assembled on the adapter seat 31, and the base 32 that can be fixed to the body surface 90 is close to the body surface 90 and fixed in position relative to the body surface 90. The base 32 can be rigid or a flexible restraint.

[0254] The guiding device 30 is relatively fixed to the body surface 90 through the base 32, and the puncture sheath 20 is assembled on the adapter seat to position the puncture point and puncture angle of the puncture sheath 20. That is, through the cooperation of the adapter seat 31 and the base 32, the puncture path of the puncture sheath 20 can be positioned on the planned implantation path L, and the puncture sheath 20 can maintain a working state of extending puncture along the implantation path L.

[0255] In one embodiment, a curved guide rail is fixed to the base 32, the adapter 31 is slidably mounted on the curved guide rail, and the puncture sheath 20 is movably positioned and inserted into the adapter 31. The adapter 31 slides along the curved guide rail, and the arc defines a first plane. The bending wire 19 bends the puncture sheath 20 in a second plane at the distal end, and the first and second planes are perpendicular.

[0256] In this embodiment, the fixed handle of the puncture sheath 20 can be slidably mounted on the adapter seat 31 , and a scale indicating the relative position of the puncture sheath 20 and the guide device 30 is further provided on the tube body of the puncture sheath 20 .

[0257] 14 , a reference horizontal plane P can be assumed with the heart position O as a reference. Under the guidance of the guiding device 30 , the puncture sheath 20 can move in the hemispherical space above the reference horizontal plane P and maintain a predetermined angle.

[0258] If the adapter 31 of the guide device 30 remains stationary, the puncture sheath 20 can only slide, for example, moving back and forth along the implantation path L1. If the relative position of the puncture sheath 20 and the adapter 31 is maintained, and only the adapter 31 is moved, for example, simplifying the two-dimensional movement of the puncture sheath 20 in a certain plane, the angle M between the two extreme positions of the puncture sheath 20's movement range is 180 degrees. When it is necessary to switch the implantation path, the adapter 31 is driven to move the puncture sheath 20 along the implantation path L1, implantation path L2, or implantation path L3.

[0259] The system of the present application may also be provided with an imaging system 40 for real-time display of the treatment site and the puncture sheath, specifically at least one of ultrasound, CT, and MRI. The implant delivery system of the present application may also be provided with a simulation navigation system for real-time display of the treatment site and the puncture sheath.

[0260] The simulated navigation system pre-creates a three-dimensional model of the heart. During use, the system uses imaging equipment to capture the treatment needle position in real time and displays it on the corresponding location on the heart model. Preferably, the guidance device is equipped with an ultrasound probe 33, which transmits real-time information about the electrode position or distal position of the puncture sheath to the imaging system. The simulated navigation system plans the implantation path and electrical stimulation treatment positions based on the heart model and can control the guidance device to adjust the movement of the puncture sheath.

[0261] In one embodiment of this application, the system also features a biopsy needle for puncturing the ventricular myocardium for biopsy. Using this needle, tissue extraction can be performed before, during, and after surgery to assess changes in the lesion site and assess surgical outcomes. Tissues extracted can include body fluids, muscle, and more. The puncture sheath can also serve as the biopsy needle. The following describes the delivery system structure in detail, using the example of an implanted electrode.

[0262] The implant delivery system of the present application includes at least one electrode 60 that can be placed into the ventricular myocardium, a pulse generator 80, and a puncture sheath 20, wherein the pulse generator 80 is used to generate electrical stimulation, and the electrode 60 is electrically connected to the pulse generator 80 by a separate connection or an integrated manner.

[0263] As shown in Figure 17, the proximal end of the electrode 60 is connected to a connecting wire 54 through a threading hole 53. When the electrode 60 and the pulse generator 80 are integrated and packaged together, or when the electrode 60 is electrically connected and communicated with the pulse generator 80 wirelessly, the connecting wire 54 serves as a traction wire, connecting the electrode 60 to the delivery system. When the electrode 60 is delivered to the implantation site, the traction wire is withdrawn to release the electrode 60. When the electrode 60 and the pulse generator 80 are integrated and packaged together, the connecting wire 54 serves as a traction wire. When the electrode 60 is delivered to the implantation site, the traction wire is withdrawn to release the electrode 60. When the electrode 60 is electrically connected and communicated with the pulse generator 80 by wire, the connecting wire 54 serves as a conductor, used to establish an electrical connection between the electrode 60 and the pulse generator 80.

[0264] As shown in Figure 18, for example, in a split connection mode, the electrode 60 is electrically connected to the pulse generator 80 through a wire, or is electrically connected and communicated with the pulse generator wirelessly. During implantation, the pulse generator can be placed in a subcutaneous pouch next to the sternum using a common pacing electrode implantation method.

[0265] As shown in Figure 19 , in an integrated approach, the electrode 60 and pulse generator 80 are integrated and packaged together. For example, the device may include a housing and a pulse generator 80 located within the housing, with the electrode 60 exposed outside the housing. In one embodiment, the housing is capsule-shaped, with the electrode 60 extending from one end of the housing and exposed. The puncture sheath includes a hollow tube into which the electrode is releasably placed.

[0266] As shown in Figure 20, in one embodiment, in order to anchor the electrode 60 at a predetermined position after it is implanted in the body, the electrode 60 may also have an anchor 601. The anchor 601 is spiral and its outer diameter gradually converges. When the electrode 60 is implanted, the anchor 601 can be inserted into and fixed to the surrounding tissue by rotating the electrode 60.

[0267] Referring to Figure 21, in another embodiment, the anchor 601 is made of memory metal. When delivered in the body, the anchor 601 can be attached to the outer periphery of the electrode 60 under the restraint of the external tube. When it reaches the predetermined position, the restraint is released, and the anchor 601 restores the predetermined posture in the body, turns outward to form a barb structure, and is anchored to the surrounding tissue.

[0268] Referring to Figure 22, in another embodiment, other implantation paths for the electrode 60 are also provided, for example, the electrode 60 can be inserted into the inferior vena cava through surface puncture, enter the right atrium 11 through the inferior vena cava, then pass through the atrial septum to enter the left atrium, and then pass through the mitral valve to enter the left ventricle 1, and then the electrode 60 is released and anchored to the ventricular free wall 7. The number of electrodes 60 can be one or more, and the implantation position can be located on the ventricular free wall or ventricular septum as described in the above embodiments, and can be specifically combined with the above embodiments for interventional delivery.

[0269] Referring to Figure 23, in another embodiment, other implantation paths for the electrode 60 are provided. For example, the electrode 60 can be implanted through surface puncture into the inferior vena cava or the superior vena cava to enter the right atrium 11, and then pass through the tricuspid valve to enter the right ventricle 2. The electrode 60 is then released and anchored to the ventricular free wall of the right ventricle 2. The number of electrodes 60 can be one or more, and the implantation position can be located at the ventricular free wall or the ventricular septum as described in the above embodiments. Specifically, interventional delivery can be performed in combination with the above embodiments.

[0270] The technical features of the above-described embodiments may be combined in any manner. To simplify the description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as no contradiction exists between these combinations of technical features, they should be considered to be within the scope of this specification. When technical features of different embodiments are embodied in the same drawing, it can be deemed that the drawing also discloses examples of combinations of the various embodiments involved.

[0271] The above-described embodiments merely represent several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that a person skilled in the art may make various modifications and improvements without departing from the spirit of the present application, and such modifications and improvements are all within the scope of protection of the present application.

Claims

1. An implant delivery system, characterized in that: include: Transcatheter sheaths and implants; The puncture sheath comprises a hollow tube body, the implant is releasably placed in the tube body, the distal end of the tube body is a puncture head that can penetrate the ventricular myocardium and guide the tube body to pass through the ventricular myocardium, and the length of the tube body can at least extend from the outside of the body through the apex to the inside of the ventricular myocardium.

2. The implant delivery system according to claim 1, characterized in that A pushing device is slidably disposed in the tube body, and the distal end of the pushing device can push the implant to release the tube body; The pushing device is tubular and has a guide channel inside. A connecting wire is fixed to the proximal end of the implant or is releasably provided with a connecting wire, and the connecting wire extends to the proximal end through the guide channel.

3. The implant delivery system according to claim 1, characterized in that The interior of the tube body includes a first cavity and a second cavity, the two cavities extend side by side from the distal end to the proximal end, and a plurality of implants are arranged in the first cavity along the length direction; There is a partition between the two cavities, and the partition is arranged with multiple avoidance holes. For each implant, there is at least one avoidance hole on the proximal side of the implant. The connecting line of each implant extends from the avoidance hole to the second cavity, and extends from the second cavity to the proximal end of the tube body.

4. The implant delivery system according to claim 3, characterized in that: An interactive damping structure is provided between the first cavity and each implant.

5. The implant delivery system according to claim 3, characterized in that: A pushing device is arranged in the second cavity, and the pushing device is tubular and used for receiving the connecting line.

6. The implant delivery system according to claim 5, characterized in that: The pushing device can enter the first cavity along the connecting line through the corresponding avoidance hole and push the corresponding implant; the connecting line is a guide wire or a traction wire.

7. The implant delivery system according to claim 1, characterized in that The implant is an implantable electrode, the system further comprises a pulse generator, the electrode and the pulse generator are arranged separately, and the electrode has a smooth outer surface; or The electrode and the pulse generator are integrated and have a smooth outer surface after integration.

8. The implant delivery system according to claim 1, wherein: The implant is an implantable electrode. The system further comprises a pulse generator. The electrode is provided with an anchoring member acting on surrounding tissues. The electrode and the pulse generator are arranged separately or integratedly.

9. The implant delivery system according to claim 1, wherein: The length of the tube is 12 to 20 cm.

10. The implant delivery system according to claim 1, wherein: A bending adjustment wire is movably inserted into the tube body, the distal end of the bending adjustment wire is connected to the inner wall of the puncture head, and the proximal end of the bending adjustment wire extends out of the tube body as a force-applying end for pulling the puncture head to change its direction.

11. The implant delivery system according to claim 10, characterized in that: The implant delivery system also includes a fixed handle, a transition cavity is provided in the fixed handle, the proximal end of the tube body is sealed and inserted into the fixed handle, and the inner cavity of the tube body is connected to the transition cavity, an electrode input port connected to the transition cavity is provided on the fixed handle, and the proximal end of the bending wire extends out of the fixed handle.

12. The implant delivery system according to claim 11, characterized in that A branch pipe communicating with the transition cavity is provided on the side wall of the fixed handle, and the bending adjustment wire extends out of the fixed handle from the branch pipe.

13. A cardiac rhythm adjustment system, characterized in that: include: The electrode is at least one and can be placed in the ventricular myocardium; The puncture sheath comprises a hollow tube body, in which the electrode is releasably placed, the distal end of the tube body is a puncture head which can penetrate into the ventricular myocardium and guide the tube body to pass through the ventricular myocardium, and the length of the tube body can at least extend from outside the body to inside the ventricular myocardium.

14. The cardiac rhythm regulation system according to claim 13, characterized in that: The electrode is passed through the epicardium into the ventricular myocardium.

15. The cardiac rhythm regulation system according to claim 13, characterized in that: The electrode is passed through the endocardium and into the ventricular myocardium.

16. The cardiac rhythm regulation system according to claim 13, characterized in that: The implantation site of the electrode is a predetermined electrical stimulation site, and the predetermined electrical stimulation site is located at least one of the ventricular septum myocardium, the left ventricular free wall myocardium, or the right ventricular free wall myocardium.

17. The cardiac rhythm regulation system according to claim 16, characterized in that: The implantation site of the electrode is a predetermined electrical stimulation site, wherein one predetermined electrical stimulation site is close to the terminal bifurcation of the His bundle, or one predetermined electrical stimulation site is close to the left branch of the atrioventricular bundle or the right branch of the atrioventricular bundle.

18. The cardiac rhythm regulation system according to claim 16, characterized in that: There are one or more electrodes in the ventricular septum myocardium, and the electrodes are distributed at intervals along the long axis of the ventricular septum.

19. The cardiac rhythm regulation system according to claim 16, characterized in that: There are one or more electrodes in the ventricular free wall myocardium, and the electrodes are distributed at intervals along the long axis of the ventricular free wall.

20. The cardiac rhythm regulation system according to claim 16, characterized in that: The electrodes located in the ventricular septum myocardium are pacemaker electrodes, and the electrodes located in the ventricular free wall myocardium are pacemaker electrodes and / or defibrillator electrodes.

21. The cardiac rhythm regulation system according to claim 13, characterized in that: The electrodes are one group or more than two groups, and electrodes in different groups enter along the same puncture point.

22. The cardiac rhythm regulation system according to claim 13, characterized in that: The electrodes are in one group or more than two groups, each group of electrodes has one or more than two electrodes, and the electrodes in the same group correspond to an arrangement path in the ventricular myocardium, and the same arrangement path extends approximately along a straight line.

23. The cardiac rhythm regulation system according to claim 22, characterized in that: The arrangement paths are radially distributed in the ventricular muscle with the apex as the center; or the arrangement paths are parallel to each other in the ventricular muscle, and the arrangement paths are arranged in the ventricular muscle along the long axis of the heart.

24. The cardiac rhythm regulation system according to claim 13, characterized in that: The cardiac rhythm adjustment system also includes: A pulse generator is connected to the electrode through a circuit, and the electrode and the pulse generator are arranged separately or integrated.

25. The cardiac rhythm regulation system according to claim 13, characterized in that: The cardiac rhythm adjustment system also includes: The guiding device comprises a base that can be fixed on the body surface and an adapter seat that is mounted on the base and can adjust its position. The puncture sheath is assembled on the adapter seat.

26. The cardiac rhythm regulation system according to claim 25, characterized in that: An arc-shaped guide rail is fixed on the base, the adapter seat is slidably mounted on the arc-shaped guide rail, and the puncture sheath is movably positioned and penetrated through the adapter seat.

27. The cardiac rhythm regulation system according to claim 26, characterized in that: A bending wire is movably inserted into the tube body; The arc-shaped guide rail defines a first plane, the bending wire pulls the puncture sheath to bend in a second plane at the distal end, and the first plane is perpendicular to the second plane.

28. The cardiac rhythm regulation system according to claim 25, characterized in that: The cardiac rhythm adjustment system also includes: Imaging system, used to guide the puncture sheath and display the electrode position.

29. The cardiac rhythm regulation system according to claim 28, characterized in that: The adapter is provided with an ultrasonic probe, which collects the electrode position and the puncture sheath posture in real time and simulates and displays them through the imaging system; During simulation display, the electrode position and puncture sheath posture are displayed at corresponding positions of the pre-constructed heart model for comparison with the predetermined implantation position.

30. The cardiac rhythm regulation system according to claim 13, characterized in that: The implantation site of the electrode is a predetermined electrical stimulation site, and the cardiac rhythm adjustment system further comprises: The simulation navigation system is used to indicate the electrical stimulation position and the relative position of the electrodes in real time. The simulation navigation system pre-models the heart in three dimensions. When in use, the simulation navigation system collects the electrode position in real time through the imaging system and displays it at the corresponding position of the heart model for comparison with the predetermined electrical stimulation position.

31. The cardiac rhythm regulation system according to claim 13, characterized in that: The cardiac rhythm adjustment system also includes: The pushing device is tubular and has a guide channel inside. The electrode is connected to a connecting wire, and the connecting wire extends toward the proximal end through the guide channel.

32. The cardiac rhythm regulation system according to claim 13, characterized in that: The interior of the tube body includes a first cavity and a second cavity, and the two cavities extend side by side from the distal end to the proximal end. A plurality of electrodes are arranged in the length direction in the first cavity; a partition is provided between the two cavities, and a plurality of avoidance holes are arranged in the partition. For each electrode, there is at least one avoidance hole on the proximal side of the electrode, and each electrode is connected to a connecting wire, and each connecting wire extends from the avoidance hole to the second cavity, and extends from the second cavity out of the proximal end of the tube body.

33. A method for adjusting heart rhythm, characterized in that: include: Planning the implantation path; Providing a delivery system pre-installed with electrodes, and delivering the delivery system along an implantation path into the ventricular myocardium of a human heart; The electrode is released.

34. The heart rhythm adjustment method according to claim 33, characterized in that: The delivery system comprises a puncture sheath for loading the electrode, and the delivery of the electrode comprises puncturing the electrode through an epicardial approach to the distal end of the puncture sheath to reach a predetermined electrical stimulation site.

35. The heart rhythm adjustment method according to claim 33, characterized in that: The delivery system adopts a transcatheter approach, and the delivery of the electrode includes a transendocardial puncture route into the myocardium; The electrode is then released and maintained at a predetermined electrical stimulation position, and electrical stimulation is performed accordingly.

36. The heart rhythm adjustment method according to claim 33, characterized in that: The planned implantation path includes: Collect basic heart data; Performing three-dimensional modeling of the heart to obtain a heart model; performing acquisition based on one or more of three-dimensional ultrasound, CT, or MRI to display the structures of the ventricular septum, ventricular free wall, and endocardium in the heart model; Calculate the electrical stimulation site and plan the corresponding implantation path.

37. The heart rhythm adjustment method according to claim 33, characterized in that: The distal end of the delivery system is a puncture tip.

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