Novel single-disc patent foramen ovale plugging device

Abstract

The utility model belongs to the technical field of medical instruments, and particularly discloses a novel single-disc patent foramen ovale plugging device which structurally comprises a front disc, a rear support, a waist portion connecting the front disc and the rear support, a flow blocking film arranged in the front disc and wrapping the rear support, and a screw arranged on the outer side of the rear support. The front disc of the plugging device covers the left chamber outlet of the oval foramen after being unfolded, and shunting can be stopped as much as possible; the rear support in the right atrial septum is clamped on the right atrial septum after being unfolded, and the disc face of the left atrial septum is more tightly attached to the left atrial exit of the oval hole under the action of traction force of the rear support. Compared with a traditional foramen ovale plugging device, the foramen ovale plugging device can reduce shunting and thrombosis, and is better in applicability to long and narrow foramen ovale.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to a novel single-disc patent foramen ovale occluder. Background Art

[0002] At present, the main method of treating PFO is to implant a patent foramen ovale occluder through minimally invasive surgery. The occluders currently used are double-disc "I"-shaped structures woven from nickel-titanium alloy. The safety and effectiveness of this occluder have been confirmed by numerous clinical studies. However, it still has the following shortcomings: (1) Since the thickness of the septum at the oval fossa is lower than that of the surrounding atrial septum area, and the shape of the oval fossa is individualized and irregular, traditional occluders cannot fit tightly after implantation. Especially on the left atrial disk of the occluder, shunts often still occur after occlusion because the left atrial opening of the foramen ovale cannot be tightly wrapped. (2) Traditional occluders use a two-disc structure with a lot of metal material, which leads to a long postoperative endothelialization time, and the metal material has a large contact area with the blood, which can easily lead to thrombosis. (3) Traditional occlusion uses an atrial septal defect occluder with a wide waist, but the foramen ovale is narrow and long. Therefore, after the occluder is released, the expanded waist of the occluder will cause the front and rear discs of the occluder to deviate slightly from their positions, making the disc not tightly enough to occlude the foramen ovale outlet. Utility Model Content

[0003] In order to solve the above problems, the utility model provides a novel single-disc patent foramen ovale occluder, which uses less metal material while reducing shunt as much as possible and has better applicability to narrow and long foramen ovale.

[0004] In order to achieve the above purpose, the specific technical solutions adopted by the utility model are as follows:

[0005] A new single-disc patent foramen ovale occluder, comprising:

[0006] The front disc is a woven mesh structure that can be expanded and retracted, and is in the shape of a disc when expanded;

[0007] The rear support comprises a central connecting portion and a plurality of circumferential anchoring columns which are distributed in an umbrella shape and whose inner ends are connected to the central connecting portion, wherein the circumferential anchoring columns are made of elastic material so that they can be expanded and retracted;

[0008] A waist portion, connected to the front plate and the rear bracket, with two ends respectively fixed to the front plate and the central connecting portion;

[0009] The flow-blocking film comprises a first flow-blocking film arranged in the front disk and a second flow-blocking film wrapped in the rear support. The flow-blocking film is a film coated with endothelialization-promoting drugs.

[0010] The occluder structure is folded into the delivery sheath before use, and is pushed out of the delivery sheath by a push rod to unfold and function.

[0011] When the utility model performs the blocking operation, the front disc is unfolded to cover the left atrial outlet of the oval foramen, which can prevent shunt as much as possible; the rear stent in the right atrium is unfolded and stuck in the right atrial septum, and under the traction of the rear stent, the disc surface of the left atrium is more closely fitted to the left atrial outlet of the oval foramen; the waist is inserted into the oval foramen to connect the front disc and the rear stent. The inventor found that the front disc is more effective when placed in the left atrium. When the front disc is placed in the right atrium, some thrombi that have already formed will fall in the oval foramen, causing the patient to have migraine for a period of time after the blocking, while placing it in the left atrium can effectively avoid this problem.

[0012] Preferably, a screw is provided on one side of the central connection portion away from the waist. The screw is used to connect with a nut of a push rod. When the rear support is fully deployed, the push rod is rotated to release the occluder, and the occluder can be recovered by reconnecting the screw.

[0013] Preferably, the front disc, waist and rear bracket are all made of nickel-titanium alloy, and are all woven from nickel-titanium alloy wires. Nickel-titanium alloy is a memory alloy with good elasticity and deformation recovery ability, which can meet the requirements of the front disc and rear bracket for expansion and contraction. The rear bracket of the braided anchoring column structure uses less metal material than the rear disc of the traditional occluder, which can accelerate endothelialization and reduce thrombosis.

[0014] Preferably, the waist is a bundle of threads that naturally gathers from the center when the front disc is unfolded.

[0015] Preferably, the maximum radial dimension of the rear bracket does not exceed the diameter of the front disc.

[0016] Preferably, the diameter of the waist is 1-3 mm. Compared with the traditional occluder, the waist is set to be thinner to better adapt to the narrow and long oval foramen and avoid the wide waist affecting the occlusion effect.

[0017] Preferably, after the rear stent is deployed, the circumferential anchoring columns are inclined toward the front disc and are arc-shaped, so that the rear stent can be more tightly clamped in the right atrium.

[0018] The utility model has the following beneficial effects:

[0019] 1. The right atrial part of the occluder is not a disc-shaped structure, but a smaller umbrella-shaped stent structure woven from alloy wires composed of anchoring columns and wrapped with a flow-blocking membrane coated with endothelialization-promoting drugs. This can reduce the use of metal materials in the occluder, reduce the area of ​​contact between the exposed metal part of the occluder and the blood, reduce the formation of thrombus, accelerate endothelialization, and provide a puncture-able solution for future transseptal surgery.

[0020] 2. This occluder is different from most traditional occluders in that the front disc is small and the rear disc is large. Its front disc is larger, which can effectively prevent the existing thrombus in the foramen ovale from flowing out to the left heart system; the umbrella-shaped rear stent replaces the round rear disc, which can be tightly stuck in the right atrium, improving the stability of the occlusion.

[0021] 3. The waist of this occluder is smaller than that of traditional occluders and is more suitable for narrow and long foramen ovale. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 : Schematic diagram of the structure of the new single-disc patent foramen ovale occluder described in Example 1.

[0023] Figure 2 : Figure 1 Left view of .

[0024] In the figure: 1-front plate, 2-waist, 3-rear bracket, 4-screw; 31-center connecting part, 32-circumferential anchoring column. DETAILED DESCRIPTION

[0025] The present invention is further described below in conjunction with the accompanying drawings and specific embodiments.

[0026] Example

[0027] A new single-disc patent foramen ovale occluder, the structure of Figure 1-2 As shown, it includes a front disc 1, a waist 2, a rear bracket 3, a spoiler film and screws 4.

[0028] Specifically, the front disc 1, waist 2 and rear bracket 3 are all woven from nickel-titanium alloy wires. The front disc 1 is a net bag structure with a closed opening, which can be unfolded and folded. It is in the shape of a disc when unfolded and in the shape of a bundle when folded. A circular first flow-blocking membrane is arranged inside the front disc 1, and the first flow-blocking membrane is parallel to the disc surface of the front disc after unfolding. The waist 2 is a bundle of nickel-titanium alloy wires that is naturally gathered at its central closing when the front disc 1 is unfolded. The end of the waist 2 is connected to the rear bracket 3. In this embodiment, the diameter of the waist 2 is 2 mm. The rear bracket 3 includes a central connecting portion 31 and five circumferential anchoring columns 32 that are evenly distributed in an umbrella shape and connected to the central connecting portion 31 at the inner end and can be opened and closed due to elastic deformation; after the rear bracket 3 is unfolded, the circumferential anchoring columns 32 are inclined toward the direction of the front disc 1 and are arc-shaped. In addition, the maximum radial dimension of the rear bracket 3 after unfolding is smaller than the diameter of the front disc 1; the rear bracket 3 is also wrapped with a second flow-blocking membrane. The inner side of the central connecting portion 31 is fixedly connected to the waist portion 2 , and the screw 4 is disposed on a side of the central connecting portion 31 away from the waist portion 2 .

[0029] The working process of the novel single-disc patent foramen ovale occluder is as follows:

[0030] First, establish femoral vein access through the right cardiac catheter, fix the screw 4 on the rear side of the occluder on the nut of the push rod, and put the rear stent 3, waist 2, and front disc 1 into the delivery sheath in the order of the occluder. Send the delivery sheath into the left atrium through the oval foramen, release the front disc 1, and open the front disc 1 to cover the left atrium outlet of the PFO. After observing its stable shape, withdraw the delivery sheath to the right atrium and release the rear stent 3 in the right atrium of the occluder. After the umbrella-shaped stent of the right atrium of the occluder is unfolded, it is stuck on the right side, and the front disc 1 is pulled to cover the left atrium opening of the PFO tightly. Observe the residual shunt state under echocardiography until there is no shunt, release the occluder, and withdraw the delivery sheath and push rod.

[0031] This specific implementation method is only an explanation of the utility model, not a limitation of the utility model. Any changes made by those skilled in the art after reading the specification of the utility model will be protected by the patent law as long as they are within the scope of the claims of the utility model.

Claims

1. A novel single-disc patent foramen ovale occluder, characterized in that: include: The front disc (1) is a woven mesh structure that can be unfolded and folded, and is in the shape of a disc when unfolded; The rear support (3) comprises a central connecting portion (31) and a plurality of circumferential anchoring columns (32) distributed in an umbrella shape and having inner ends connected to the central connecting portion (31), wherein the circumferential anchoring columns (32) are made of elastic material so that they can be expanded and retracted; A waist portion (2) connected to the front plate (1) and the rear support (3), with two ends respectively fixed to the front plate (1) and the central connecting portion (31); A flow-blocking film, comprising a first flow-blocking film arranged in the front disk (1) and a second flow-blocking film wrapped around the rear bracket (3); When in use, the front disc (1) is unfolded to cover the left atrial outlet of the oval foramen, the waist (2) is inserted into the oval foramen, and the rear support (3) is unfolded to be stuck in the right atrial septum.

2. The novel single-disc patent foramen ovale occluder according to claim 1, characterized in that: A screw (4) is provided on a side of the central connecting portion (31) away from the waist portion (2).

3. The novel single-disc patent foramen ovale occluder according to claim 1, characterized in that: The front disc (1), waist (2) and rear support (3) are all made of nickel-titanium alloy and are all woven from nickel-titanium alloy wires.

4. The novel single-disc patent foramen ovale occluder according to claim 1, characterized in that: The waist (2) is a bundle of silk that naturally gathers from the center of the front disc (1) when the front disc (1) is unfolded.

5. The novel single-disc patent foramen ovale occluder according to claim 1, characterized in that: There are at least three circumferential anchoring columns (32) which are evenly distributed.

6. The novel single-disc patent foramen ovale occluder according to claim 1, characterized in that: The maximum radial dimension of the rear bracket (3) does not exceed the diameter of the front disc (1).

7. The novel single-disc patent foramen ovale occluder according to claim 1, characterized in that: The diameter of the waist (2) is 1-3 mm.

8. The novel single-disc patent foramen ovale occluder according to claim 1, characterized in that: After the rear bracket (3) is unfolded, the circumferential anchoring column (32) is inclined toward the front disc (1) and is in an arc shape.

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