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EP-4260814-B1 - PUNCTURABLE INTERATRIAL SEPTUM OCCLUDER

EP4260814B1EP 4260814 B1EP4260814 B1EP 4260814B1EP-4260814-B1

Inventors

  • PAN, WENZHI
  • ZHOU, Daxin
  • GE, JUNBO

Dates

Publication Date
20260506
Application Date
20210709

Claims (5)

  1. A puncturable atrial septal occluder, comprising a stent made by heat setting after integrally braiding a wire material with a memory property, the stent consisting of a left disc (1), a right disc (2), and a waist (3) that are connected, the occluder further comprising a central through hole (4) that penetrates the stent, and a notch formed at the centers of the left disc (1) and the right disc (2), wherein the left disc (1), right disc (2), and the waist (3) are of an integral mesh-shaped structure with a wire material as a memory alloy material, the left disc (1) and the right disc (2) both have a double-layer mesh-shaped structure, edges of notches at centers of the left disc (1) and the right disc (2) are both densely woven, a weaving density of a reinforced weaving area is 2-5 times as much as that of other common areas, the central through hole (4) has a diameter close to an inner diameter of the waist (3) to the greatest extent and is configured such that a puncture sheath is capable of passing therethrough, a baffle membrane (5) is provided inside the central through hole (4) to block the central through hole (4) from the inside thereof; a notch at the center of the right disc (2) is provided with a plurality of connecting wires (6), one end of each of the plurality of connecting wires (6) is converged and connected to a delivery component (7), and the other end of each of the plurality of the connecting wires (6) is radially connected to the right disc (2) with regards to the center of the right disc (2), characterized in that the plurality of the connecting wires (6) are distributed rotatably and symmetrically with respect to a delivery component (7) and the central through hole (4), and a gap through which the puncture sheathing canal can pass is provided between the adjacent connecting wires, a number of the connecting wires (6) is at most 12, and at least 3, the delivery component (7) is configured as a wire-clamping steel sleeve or a condensed ball, one end of the delivery component (7) is connected to the connecting wire, the other end of the delivery component (7) is a free end, and the free end is provided with a connecting port, and connected to a delivery system, so that the puncturable atrial septal occluder is capable of being pulled into or pushed out of a delivery sheath.
  2. The puncturable atrial septal occluder according to claim 1, wherein the occluder has morphological memory, with two morphologies of contraction and expansion.
  3. The puncturable atrial septal occluder according to claim 1, wherein the baffle membrane (5) has a sheet shape and is made of a polymer material or a degradable material, and the sheet-shaped morphology of the baffle membrane has a cross sectional shape being the same as the central through hole (4).
  4. The puncturable atrial septal occluder according to claim 1, wherein a connecting position of the connecting wire (6) on the right disc (2) is an outer layer of the right disc (2), and a connecting method is an integral weaving and shaping connection or a split-type physical connection, the connecting wire (6) of the split-type physical connection is made into an independent structure and made of metal or a polymer wire material or a degradable polymer material, and then connected to the right disc (2).
  5. The puncturable atrial septal occluder according to claim 4, wherein the split-type physical connection is specifically welding or braiding or suture.

Description

Technical Field The present invention relates to the field of medical device technologies, and more particularly, to a puncturable atrial septal occluder. Background of the Invention An atrial septal defect is a common congenital heart disease. A current mainstream treatment is to use an occluder to perform a percutaneous (a femoral vein) atrial septal occlusion. In this operation, the occluder is one of the most important medical device. The occluder currently in use is of an "H"-shaped double-disc and one-waist nickel-titanium alloy woven structure, and the safety and effectiveness of the structure have been widely clinically proven. Most of patients undergoing atrial septal defect occlusion are young patients, and there is a high probability of complications such as atrial fibrillation and mitral regurgitation in a later stage. These complicated diseases can be treated by radiofrequency ablation, left atrial appendage occlusion, mitral valve clamping, etc., which puncture an atrial septum again into a left atrium via a femoral vein for a minimally invasive interventional surgery. However, due to a large volume and a dense mesh of the occluder in a prior art, the entire atrial septum is almost filled up after implantation in the human body. A double-disc, four-layer, dense-mesh and small-mesh (φ2mm) design makes it impossible to puncture the atrial septum to deliver a sheathing canal (φ3-9mm) into the left atrium. As a result, the patient loses an interventional channel of the atrial septum, and also loses an opportunity of minimally invasive interventional treatments for the atrial fibrillation, the mitral valve regurgitation and other diseases. For example, an occluder a disclosed in the patent CN2524710Y (see FIG. 1) has a double-disc and one-waist structure, which is not provided with a central through hole, resulting in a puncture sheathing canal being unable to pass through the occluder a at all in later need to puncture. An occluder b disclosed in the patent CN101234042A (see FIG. 2) also has a double-disc and one-waist structure. Similarly, the occluder b is not provided with a central through hole, and a memory alloy wire is added in a waist. When the atrial septal puncture is needed later, the occluder b cannot be passed through at all. On the basis of the forgoing patent technology, the applicant designed an occluder c disclosed in the patent CN206228378U (see FIG. 3). The occluder has a small hole at the center thereof, which is designed to leave a small through hole for an incompletely enclosed atrial septum defect so that blood can still flow through the small through hole to relieve the patient's condition after the occurrence of pulmonary hypertension in a later stage. The occluder does not completely enclose a defective atrial septum, and a blood flow can still pass through the through hole, which causes a blocking effect to descend. The size of the central through hole is too small (φ5-8mm, a waist has a much greater diameter than the through hole), which makes it difficult for a delivery sheathing canal (φ3-9mm) to pass through the defect. Further, the through hole itself has a certain length and the delivery sheathing canal is curved, which further makes it difficult for the delivery sheathing canal to pass through the through hole. The occluder may even be driven by a hanging wall, causing more serious consequences. Patent document US20170273790A1 discloses a blood flow regulator device, intended for implantation in the atrial septum of the heart. The primary function of the device is to regulate blood flow and manage pressure differentials within the heart, which can be beneficial in treating conditions such as heart failure or pulmonary hypertension. The device features a proximal disc, a distal disc, and a neck section that forms a cavity to maintain the desired blood flow rate. The distal disc includes loops of wire that ensure a smooth surface to promote endothelialization and reduce the risk of emboli formation. To this end, it is very necessary to design an atrial septal occluder that can safely and easily puncture and keep the atrial septal occlusion safe and effective. Summary of the Invention The invention is set out in the appended set of claims. The present invention breaks through the problems of the prior art, and designs a safe and effective atrial septal occluder that can support an apparatus to be punctured at the center thereof and be delivered with a sheathing canal. Based on the premise of guaranteeing the atrial septal occluder to be safe and effective, the atrial septal occluder reserves a channel for an interval puncture intervention surgery, giving a patient the opportunity to perform a minimally invasive interventional surgery across an atrial septum. In order to achieve the forgoing objective, the present invention designs a puncturable atrial septal occluder, including a stent made by heat setting after integrally weaving a wire material with a memory proper