Intravenously implanted automatic disc tip fixation ventricular defibrillation pacing lead

Abstract

The invention relates to an intravenously implanted automatic disc tip fixation ventricular defibrillation pacing lead comprising a head, a body and a tail, wherein the body and the head are connectedby a male and female plug mode, the body and the tail are fixedly connected, an IS-1 connector is used at the tail, the body is made of a lead with the diameter of 1-2mm, a first independent electrode and a second independent electrode are arranged on the body, the distance between the first independent electrode and the head is 10-20mm, and the distance between the second independent electrode and the first independent electrode is 10-20mm. The head is 2 metal cages in the shape of a double-sided disc, the double-sided discs are connected by a cylindrical waist with the diameter of 2-4mm andthe length of 8-16mm, and each metal cage is made of a shape memory alloy wire. The lead has the advantages of effectively reducing the risk of thrombus adhesion events caused by the defibrillation placing lead as a cohesive core and reducing the occupying effect of the defibrillation pacing lead in the implanted blood vessel and the influence on blood flow.

Description

technical field [0001] The invention belongs to the technical field of medical devices, and in particular relates to a transvenous implantation of an automatic fixing disk-shaped head-end ventricular defibrillation pacing electrode lead. Background technique [0002] There are both theoretical and technical problems in the ventricular pacing and defibrillation lead wires selected in the installation of the existing implantable cardioverter defibrillator. [0003] The main deficiency in the implantation concept is that the structure pattern of the defibrillation electrode lead used for transvenous implantation is similar to the overall pattern structure of the head, body and tail of the pacing electrode lead, and the defibrillation electrodes are arranged in the The body of the lead wire is helically wound into a cylindrical shape, not a paddle defibrillation electrode. The corresponding transvenous implantation of defibrillation electrode lead implantation surgical methods,...

AI Technical Summary

Problems solved by technology

[0003] The main deficiency in the concept of implantation is that the structure model of defibrillation lead wires implanted through veins is similar to the integral model structure of head, body and tail of pacing lead wires, and the defibrillation electrodes are set at The body of the electrode lead, shaped as a helically wound cylinder, rather than a sheet-like defibrillation electrode

The corresponding transvenous defibrillation electrode lead implantation method, including the implantation site of the lead end and the fixation method of the lead end, cannot be accurately selected, and the perioperative complications of implantation surgery and Long-term complications are not easy to control

[0004] The main deficiencies in the implantation technique lie in delivering the defibrillation lead from the right atrium through the tricuspid valve to the right ventricular cavity, finding the ideal implant target site in the right ventricular cavity, readjusting and replacing the implant The manipulative operation process such as the target site completely depends on the operator's subjective thinking and experience accumulation, and there is no objective and accurate positioning method and corresponding auxiliary equipment to complete it accurately

[0008] (2) It is impossible to implant large-area sheet defibrillation electrodes into the heart chamber

[0012] The consequences of large power, on the one hand, the service life of the defibrillator battery will be shortened, on the other hand, the damage to the patient will be greater during defibrillation, and the pain experienced by the patient will be greater

[0013] (3) Impossible to accurately implant the position of the defibrillation electrode

[0014] The existing transvenous defibrillation lead implantation technology has the same operation method and available tools as the pacing lead implantation technology, and has certain defects. When the defibrillation lead enters from the short sheath into the superior vena cava or After the upper part of the right atrium, there is no sheath delivery device that restrains and restricts the tip of the defibrillation lead from running in the heart cavity, and there is no aiming measure. The subsequent process of implanting the tip of the defibrillation lead into the target point is completely dependent on the surgeon Man-made means of operation to achieve

However, the only tool that the surgeon can use is the guide wire that runs through the central cavity of the electrode lead, and lacks objective auxiliary tools or special instruments that can accurately control and limit the tip of the defibrillation lead.

Although the existing active fixed-tip ventricular defibrillation lead wires can be implanted at any position in the right ventricular cavity in principle, the selection of implantation targets is still random in general, and it is impossible to achieve superselective ventricular pacing. The tip of the defibrillation lead is implanted in a specific part of the ventricular muscle

The position of the tip of the electrode lead cannot be accurately selected, and the position of the defibrillation electrode located on the body in the right ventricular cavity cannot be precisely positioned. Moreover, the electrode lead must maintain a low tension state in the heart cavity so as not to be pulled pulls out of place, so, to some extent, the ventricular defibrillation electrodes are floating in the RV cavity

[0015] (4) Effective fixation of the tip of the ventricular defibrillation lead cannot be achieved

[0016] The implantable cardioverter-defibrillator implantation operation is completed by using the existing ventricular defibrillation lead. If the defibrillation lead is passively fixed at the tip, the principle of immediate fixation after implantation is to rely on the defibrillation lead tip. The temporary containment between the barbels at the end and the trabecular network on the concave-convex surface of the ventricular muscle cannot achieve high-strength effective fixation. Generally, the patient is required to immobilize on the bed for three days, and the normal activities of the upper limb on the operated side are restricted within one month.

If the defibrillation lead is actively fixed at the tip of the implant, the principle of immediate fixation after implantation is to rely on the screw unscrewed from the tip of the defibrillation lead to fix it on the ventricular muscle. Generally, it will not fall off easily. Due to the limited volume of the pinned myocardial tissue, the fixation is not firm, and the patient has to avoid normal activities of the limbs on the operated side during the perioperative period

These two methods have very weak fixation strength on the tip of the defibrillation electrode lead. Whether it is implanted immediately or in the long term, there will be dislocation or micro-dislocation (poor contact), which may cause ICD sensing and defibrillation function. obstacle

[0017] (5) Surgical complications such as diaphragm muscle and phrenic nerve stimulation, cardiac perforation, and electrode displacement cannot be avoided

[0018] The implantable cardioverter-defibrillator implantation operation completed by using the existing ventricular defibrillation electrode leads, no matter whether the implanted defibrillation electrode leads are passively fixed at the head end or actively fixed at the head end defibrillation electrode leads, due to the lack of ability to The ventricular defibrillation electrode wire with a relatively soft body can be conveniently, accurately and safely delivered to the ideal target site and immediately firmly fixed to the auxiliary delivery pipeline system and control device. It is inevitable to touch the ventricular free wall when selecting the target site. Avoid the complications of diaphragm phrenic nerve stimulation; due to the lack of special tools to precisely manipulate the tip of the defibrillation lead after entering the heart chamber from the outside, the only way to push the soft lead of the body is by manipulating the guide wire in the central cavity. Failure to grasp it may result in perforation of the ventricular free wall; due to the lack of a device that can firmly fix the tip of the defibrillation electrode lead on the implanted target site immediately after implantation, short-term and long-term electrode tip contact with myocardial tissue will inevitably occur after surgery. Poor contact between electrodes, causing the risk of electrode dislocation and microdislocation

[0019] (6) Unable to solve the problem that the diameter of the electrode wire is too large

Increased power consumption, decreased battery life, increased patient discomfort and pain

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