Intravenously implanted automatic tip fixation biventricular synchronous pacing lead

Abstract

The invention relates to an intravenously implanted automatic tip fixation biventricular synchronous pacing lead comprising a head, a body and a tail, wherein the body and the head are connected by amale 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, an independent electrode is arranged on the body, and the distance between the independent electrode and the head is 10-20mm. The head is a metal cage in the shape of a double-sided disc, a cylindrical waist with the diameter of 2mm and the length of 2-3mm is arranged between a front metal disc and a rear metal disc, and the metal cage is made of a shape memory alloy wire. The lead has the advantages of avoiding the risk of thrombosis due to the pacing lead floating in the left atrium cavity with high pressure and rapid blood flow due to the fact that the ventricular pacing lead is not required to be implanted via an arterialsystem to reach the left atrium cavity.

Description

Technical field [0001] The invention belongs to the technical field of medical devices, and specifically relates to a dual-atrium synchronous pacing electrode lead that is automatically fixed at the head end through vein implantation. Background technique [0002] The main shortcoming of the current concept of central atrial pacing electrode lead implantation for permanent artificial cardiac pacemaker installation is that the concept of the most ideal pacing target site in the atrium is not proposed, and there is no clear concept guideline. Therefore, the follow-up equipment cannot be matched and the operation technology cannot be realized. Therefore, so far, there is no clinical way to achieve atrial pacing for the most ideal target site. [0003] The main disadvantage of the existing permanent artificial heart pacemaker installation technique for central atrial pacing electrode lead implantation technology is that the artificial heart pacing electrode lead is manipulated by guidi...

AI Technical Summary

Problems solved by technology

[0002] The main deficiency in the concept of atrial pacing electrode lead implantation in the existing permanent artificial cardiac pacemaker installation is that the concept of the most ideal pacing target site in the atrium has not been proposed, and there is no clear concept guidance. Therefore, the follow-up equipment cannot be matched, and the operation technology cannot be realized. Therefore, so far, there is no way to achieve atrial pacing for the most ideal target site in clinical practice.

[0003] The main disadvantage of existing permanent artificial cardiac pacemaker installation in the atrial pacing electrode wire implantation technology is that the artificial cardiac pacing electrode wire is manipulated through the central cavity guide wire running through the tail of the lead body, Implantation of the head end at the target site of the atrial septum, readjustment and replacement of the implanted target site, etc., completely rely on the operator's subjective thinking and experience accumulation, without objective and accurate positioning methods and corresponding auxiliary equipment to complete accurately

However, under our current scientific and technological conditions, the head end of the atrial pacing lead wire implanted through the vein during the permanent artificial cardiac pacemaker installation can only be implanted into the right atrium cavity, that is to say, it can only be directly implanted into the right atrium. Pacing the right atrium, while the electrical and mechanical activities of the left atrium are first driven by the pacing of the right atrium, which is obviously not as effective as directly pacing the left atrium

With the development of science and technology so far, for direct pacing of the left atrium, the tip of the pacing lead wire implanted through the vein can only be implanted through the coronary venous system to pace the epicardium, and there is no one implanted through the vein. The atrial pacing lead can be used to directly pace the left atrial endocardium

[0007] (2) Large-area endocardial pacing cannot be achieved

[0009] (3) Unable to achieve superselective pacing in the earliest excited area of ​​the atrium

[0010] Due to the relationship between the shape design of the existing passive fixed head-end pacing electrode wire, it can only be implanted in the right atrial appendage, and cannot be fixed in any other position in the right atrium, let alone at the junction of the superior vena cava and the right atrium. Around the sinoatrial node; the existing active fixed-tip pacing lead wires can be implanted at any position in the right atrial cavity in principle, but the selection of implantation targets is still random in general, and superselective implantation cannot be achieved. The tip of the atrial pacing electrode lead is implanted in a specific part of the atrium, not to mention implanted in the earliest excited area of ​​the atrium

[0011] (4) It is impossible to implant a pacing electrode lead to simultaneously pace both sides of the atrium

[0012] The basic structure and tip shape characteristics of the atrial pacing lead in the existing artificial heart pacing system determine that implanting an atrial pacing lead can only pace one side of the atrium, and it is impossible to achieve simultaneous and synchronous start of both atria. fight

In the current feasible method, in order to achieve synchronous pacing of the left and right atrium, after implanting a pacing electrode lead in the right atrial cavity, an additional left atrial pacing electrode lead must be implanted. However, the left atrial pacing electrode The implantation site of the lead end cannot be selectively implanted in the left atrium cavity, and can only reach the target site with limited left atrial free wall along the branches of the coronary vein system, so only left atrial epicardial pacing can be achieved

[0013] (5) Immediate and effective fixation of the tip of the atrial pacing lead cannot be achieved

The artificial cardiac pacemaker implantation operation completed by using the existing atrial pacing lead wire, if the implanted pacing lead lead is passively fixed at the head end, the principle of immediate fixation after implantation is to rely on the inverted whisker at the head end of the pacing lead lead Temporary containment with the trabecular network on the surface of the atrial muscle in the right atrial appendage cannot achieve high-intensity effective fixation. Generally, the patient is required to immobilize on the bed for three days, and the strenuous activities of the upper limb on the operated side should be restricted within one month.

If the pacing electrode lead is actively fixed at the tip of the implant, the principle of immediate fixation is to rely on the helix that is unscrewed from the tip of the pacing electrode lead to fix it on the atrial muscle, and 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

[0014] (6) Complications such as cardiac perforation and electrode displacement cannot be avoided

The artificial cardiac pacemaker implantation operation completed by using the existing atrial pacing lead wires, no matter whether the implantation is passively fixing the head-end pacing lead wires or actively fixing the head-end pacing lead wires, due to the lack of ability to move the body Relatively soft atrial pacing lead wires are conveniently, accurately and safely delivered to the ideal target site. The auxiliary delivery pipeline system and control device cannot avoid contact with the atrial free wall when selecting the target site. The only way to push the soft electrode lead in the body is by manipulating the metal wire in the central cavity. If the strength is not well grasped, it may cause the perforation of the atrial free wall; due to the lack of the pacing lead lead Immediately after implantation, the tip can be firmly fixed on the implanted target site. Poor contact between the short-term and long-term electrode tip and myocardial tissue is unavoidable after surgery, resulting in the risk of electrode displacement.

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