PUNCTURABLE ATRIAL SEPTUM OCCLUDER

Abstract

The present invention relates to the field of medical device technologies, and more particularly, to a puncturable atrial septal occluder. The main body of the puncturable atrial septal occluder is made by heat setting after integrally weaving a memory wire material. The occluder includes a stent formed by a left disc, a right disc, and a waist connected, a large central through hole penetrating the stent, and a notch formed at the centers of the left and right discs after the penetration. A baffle membrane is provided inside the central through hole. The notch at the center of the right disc is provided with a plurality of connecting wires. One end of each of the plurality of connecting wires is converged and connected to the delivery component, and the other end of each of the plurality of connecting wires is connected to the right disc in a radioactive manner.

Claims

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 central through hole (4) has a diameter close to an inner diameter of the waist (3) to the greatest extent, 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 part (7), and the other end of each of the plurality of the connecting wires (6) is connected to the right disc (2) in a radioactive manner.

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 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.

5. The puncturable atrial septal occluder according to claim 4, wherein the left disc (1) and the right disc (2) both have a double-layer mesh-shaped structure.

6. The puncturable atrial septal occluder according to claim 5, wherein edges of notches at centers of the left disc (1) and the right disc (2) are both densely woven.

7. 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.

8. The puncturable atrial septal occluder according to claim 7, wherein the connecting wire (6) is made of metal or a polymer wire material or a degradable polymer material when the connecting wire (6) uses the split-type physical connection.

9. The puncturable atrial septal occluder according to claim 7, wherein the split-type physical connection is specifically welding or braiding or suture.

10. The puncturable atrial septal occluder according to claim 1, wherein the connecting wires (6) are distributed rotatably and symmetrically with respect to a delivery component (7), and a gap through which a puncture sheathing canal can pass is provided between the adjacent connecting wires.

11. The puncturable atrial septal occluder according to claim 10, wherein a number of the connecting wires (6) is at most 12, and at least 3.

12. The puncturable atrial septal occluder according to claim 1, wherein 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.

13. The puncturable atrial septal occluder according to claim 8, wherein the connecting wires (6) are distributed rotatably and symmetrically with respect to a delivery component (7), and a gap through which a puncture sheathing canal can pass is provided between the adjacent connecting wires.

Description

BRIEF DESCRIPTION OF THE DIAGRAMS

[0025] FIG. 1 shows an atrial septal occluder a in a prior art.

[0026] FIG. 2 shows an atrial septal occluder b in the prior art.

[0027] FIG. 3 shows an atrial septal occluder c in the prior art.

[0028] FIG. 4 shows a top view of a puncturable atrial septal occluder according to a specific embodiment (a baffle membrane is not shown).

[0029] FIG. 5 shows a cross-sectional view of a puncturable atrial septal occluder in an expansion morphology (left and right discs are asymmetrical) according to a specific embodiment.

[0030] FIG. 6 shows a comparison diagram of a puncturable atrial septal occluder with a central encryption weaving design (left) and a non-central encryption weaving design according to a specific embodiment.

[0031] FIG. 7 shows a cross-sectional view of a puncturable atrial septal occluder in an expansion configuration (left and right discs are symmetrical) according to a specific embodiment.

[0032] FIG. 8 shows a cross-sectional view of a puncturable atrial septal occluder in a contraction configuration (left and right discs are asymmetrical) according to a specific embodiment.

[0033] Where, 1: left disc, 2: right disc, 3: waist, 4: central through hole, 5: baffle membrane, 6: connecting wire, 7: delivery component.

DETAILED DESCRIPTION OF EMBODIMENTS

[0034] The present invention is further described below in conjunction with the accompanying drawings, but is not taken as a limitation to the present invention.

[0035] It should be noted that the following detailed descriptions are all illustrative and are intended to provide further descriptions of the present invention. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by the person skilled in the art to which the present invention belongs.

[0036] It should be noted that the terms used here are only for describing specific embodiments, and are not intended to limit the exemplary embodiments according to the present invention.

[0037] In the present invention, orientation or positional relationships indicated by terms such as “upper”, “lower”, “front”, “rear”, “vertical”, “horizontal”, “side”, “bottom”, “top”, etc. are based on the orientation or positional relationship shown in the drawings. These relation terms are only determined to facilitate the description of the structural relationship of each component or element of the present invention, and do not specifically refer to any component or element in the present invention, and cannot be understood as a limitation to the present invention.

[0038] In the present invention, terms such as “fixedly connected”, “interconnected”, “connected”, etc. should be understood in a broad sense, indicating that “fixedly connected”, “interconnected”, “connected”, etc. can be a fixed connection, an integral connection or a detachable connection or can be directly connected, or be indirectly connected via an intermediate medium. For the relevant scientific research or the person skilled in the art, the specific meanings of the forgoing terms in the present invention can be determined according to the specific situation, and should not be understood as a limitation of the present invention.

[0039] In a specific embodiment, terms such as “left” and “right” correspond to left and right atrium directions in which a corresponding occluder is implanted into the heart, respectively. Left and right discs can be symmetrical discs or asymmetrical discs and can be selected according to the condition of atrial septal defect, see FIG. 5 and FIG. 7.

[0040] Referring to FIGS. 4 to 7, a puncturable atrial septal occluder is designed in a specific embodiment, and includes a left disc 1, a right disc 2, a waist 3, and a central through hole 4. The left disc 1 and the right disc 2 are connected with the waist 3. The central through hole 4 penetrates the left disc 1, the waist 3, and right disc 2 in sequence. A notch is formed at each of the centers of the left disc 1 and right disc 2. The central through hole has a diameter close to the inner diameter of the waist to the greatest extent, to ensure that a puncture sheath canal can safely and easily pass through the occluder and enter a left atrium. One to four layers of baffle membranes 5 are sewn in the central through hole 4 to completely block the central through hole 4 from the inside thereof, thereby blocking blood from circulating. The baffle membrane 5 can be made of any one of polymer materials such as a polyester tectorial membrane, a polyurethane tectorial membrane, a polytetrafluoroethylene tectorial membrane, etc., or made of a degradable material. The sheet-shape morphology of the baffle membrane has the same cross-sectional shape as the central through hole 4. Referring to FIG. 5, the central through hole 4 has a circular cross section in this embodiment, so the baffle membrane is also circular.

[0041] Referring to FIGS. 4 and 5, the notch at the center of the right disc 2 is provided with a connecting wire 6. One end of the connecting wire 6 is converged above the notch at the center of the right disc 2, and is connected to a delivery component 7. The other end of the connecting wire 6 is connected to the right disc 2 in a radioactive manner.

[0042] Preferably, the connecting position of the connecting wire 6 and the right disc 2 is an outer layer of the right disc, and a connecting method is an integral weaving and shaping connection or a split-type physical connection.

[0043] When the integral weaving and shaping connection is used for shaping, the connecting wire has the same material as a main body occluder.

[0044] When the split-type physical connection is used, the connecting wire is of an independent structure and can be made of metal or a polymer wire material or a degradable polymer material. Afterwards, the connecting wire is connected to the outer layer of the right disc by welding, weaving, or stitching. The outer layer refers to an outer surface layer in a double-layer structure of the right disc.

[0045] Preferably, the number of the connecting wires 6 is at most 12, and at least 3, and the connecting wires are arranged to be symmetrically and rotatably distributed relative to the delivery component 7. The connecting wire and the delivery component realize connection between the main body of the occluder and a delivery system, so that the occluder can be pulled in or retracted into a delivery sheath canal.

[0046] For the number of the connecting wires, too many connecting wires reduce the gap between adjacent connecting wires, resulting in the puncture sheath canal being unable to penetrate from the right disc into the central through hole or enter the left atrium. However, few connecting wires affect the delivery of the atrial septal occluder and the anchoring of the right disc in a right atrium. Therefore, with a lot of experiments, the preferred number of the connecting wires is 3 to 12.

[0047] Preferably, the left disc 1, the right disc 2, and the waist 3 are of an integral mesh-shaped structure. The integral mesh-shaped structure is made by heat setting after integrally weaving the wire material. The wire material is a memory alloy material, and preferably a nickel-titanium alloy, so that the occluder has morphological memory and hence can be allowed to be converted between a contraction morphology and an expansion morphology. Referring to FIG. 5, FIG. 7 and FIG. 8, the contraction morphology is a strip-shaped delivering morphology in which the occluder is compressed into the sheath canal. The expansion morphology is an “H”-shaped double-disc one-waist working morphology after free expansion. Since the occluder has the feature of morphology memory, the occluder can automatically restore to the working morphology from the delivering morphology, and the mesh-shaped weaving of the waist is beneficial to strengthening its support force and restoring memory morphology.

[0048] Preferably, both the left disc 1 and the right disc 2 are of a double-layer mesh-shaped structure. The double-layer structure helps strengthen the support force of the disc-shaped structure, and the mesh-shaped weaving is beneficial to the restoration of the memory morphology of the structure.

[0049] Preferably, densified weaving can be selectively used for edges of the notches at the centers of the left disc 1 and the right disc 2. Referring to FIG. 6, the weaving density of a reinforced weaving area is 2-5 times as much as that of other common areas to strengthen the ability of the occluder to restore the memory morphology.

[0050] Preferably, the delivery component 7 is configured as a wire-clamped steel sleeve or a condensed ball. One end of the delivery component 7 is connected to the connecting wire, and the other end of the delivery component 7 is a free end. The free end is provided with a connecting port and connected to the delivery system. Thus, the occluder can be pulled in or pushed out of the delivery sheath canal as a whole.

[0051] In a specific embodiment, the waist of the occluder designed in the present invention is a short waist with a length of only 2-8 mm. The central through hole is circular, so that the selected baffle membrane is also a circular sheet-shaped membrane to ensure that blood is blocked from circulating.

[0052] Further, for another special feature, the central through hole designed in the present invention has a much larger diameter than a mesh (2 mm) in the prior art. The diameter is close to the inner diameter of the waist to the greatest extent. In a specific embodiment, the diameter of the central through hole has a size between 8 mm and 46 mm, so as to ensure that the puncture sheath canal can safely and easily pass through the occluder and enter the left atrium.

[0053] The occluder designed in the present invention has many models, for example, the specifications are divided according to different diameters of the through hole. When in use, applicable models can be selected according to the condition of the atrial septal defect. In addition, the large through hole of the present invention significantly reduces the difficulty of a reserved puncture channel during puncture, and enhances the success rate of a subsequent atrial septal puncture interventional operation.

[0054] In a specific embodiment, the present invention maintains the traditional double-disc and one-waist structure and working principle to ensure the safety and effectiveness of the occluder. In addition, the large through hole with baffle membrane arranged at the center of the occluder can block the blood from flowing through the occluder. In addition, due to the fragility of the baffle membrane, the baffle membrane is easy to puncture and expand, making it very easy to puncture from the center of the occluder and deliver the sheathing canal. The present invention not only achieves the safe and effective treatment of the atrial septal defect, but also reserves the channel for a subsequent interventional operation via atrial septal puncture, thereby reserving an opportunity for the patient to perform a minimally invasive interventional operation across the atrial septal.

[0055] The forgoing is only the preferred embodiments of the present invention. It should be noted that the person skilled in the art can make a plurality of improvements and supplements without departing from the method of the present invention, and these improvements and supplements should also be considered as the protection scope of the present invention.