CN115444470A - A patent foramen ovale occluder that does not affect atrial septal puncture - Google Patents

Abstract

The invention relates to a patent foramen ovale plugging device without affecting atrial septal puncture, and belongs to the technical field of medical instruments. The puncture sheath comprises a left disc, a right disc and a waist part between the left disc and the right disc, wherein the left disc and the right disc are in long strip shapes or oval shapes, and a space for the puncture sheath to pass through the atrial septal region again is fully reserved; the left disc, the right disc and the waist are respectively provided with a flow-resisting film. The invention not only maintains the structure of the traditional occluder and ensures the safety and effectiveness of the occluder, but also fully reserves the space for the puncture sheath to pass through the interatrial space again by arranging the disk surface of the occluder into a long strip shape or an oval shape; when blocking blood flow and passing through the occluder, the reserved interatrial space is easy to puncture and expand again, so that the puncture sheath can be easily punctured and fed in again from the reserved area around the occluder, a channel is reserved for the subsequent interatrial space puncture interventional operation, and the opportunity of performing the interatrial space minimally invasive interventional operation again is reserved for a patient.

Description

A patent foramen ovale occluder that does not affect atrial septal puncture

technical field

The invention relates to a patent foramen ovale occluder which does not affect atrial septal puncture, and belongs to the technical field of medical devices. In the present invention, the side close to the left atrium is left, and the side close to the right atrium is right.

Background technique

Patent foramen ovale (Patent Foramen Oval or PFO) is a common congenital heart disease. At present, the mainstream treatment method is to use an occluder to perform percutaneous (femoral vein) patent foramen ovale closure.

As shown in Figure 1, the occluders currently used are nickel-titanium alloy braided double discs and one waist "I"-shaped structure, and their safety and effectiveness have been widely clinically proven. Most of the patients undergoing patent foramen ovale closure are young patients, and the probability of atrial fibrillation, mitral valve regurgitation and other diseases in the later stage is high. These concurrent diseases can be treated with radiofrequency ablation, left atrial appendage closure, and mitral valve clipping Wait for the femoral vein to puncture the interatrial septum into the left atrium for minimally invasive interventional surgery for treatment.

However, due to the large volume and dense mesh of the current mainstream circular disk occluder, it almost occupies the entire interatrial septum after implantation in the human body. , making it impossible to puncture the atrial septum and send the sheath (φ3-9mm) into the left atrium in the subsequent operation, making the patient lose the intervening channel of the atrial septum, and also lose the minimally invasive interventional treatment of atrial fibrillation , Mitral regurgitation and other diseases.

For example, the occluder a disclosed in Chinese Patent No. CN201949173U (see Figure 1) has a double disc and one waist structure, and the circular occluder disc will occupy the entire interatrial septum, resulting in the need for puncture again later. , the puncture sheath simply cannot pass through the occluder.

The disclosed occluder of Chinese Patent No. CN211355623U (referring to Fig. 2), is the structure of two discs and one waist equally, and this occluder of the same is also a circular disc surface, although the left and right anchor valves are used for future atrial septal puncture pre-treatment. However, when atrial septal puncture is required in the later stage, it is still difficult to puncture the atrial septum through the extremely limited area of the petal, and the few metal wires in the petal cannot provide enough fixation force, making the blockage There is a risk of falling off. Therefore, there is an urgent need in the technical field for an atrial septal occluder that can safely and easily perform atrial septal puncture again after implantation and maintain a safe and effective atrial septal occlusion.

Contents of the invention

The object of the present invention is to solve the technical problem of an atrial septal occluder that can safely and easily perform atrial septal puncture again after implantation and maintain a safe and effective atrial septal occlusion.

In order to solve the above problems, the technical solution adopted by the present invention is to provide a patent foramen ovale occluder that does not affect the puncture of the atrial septum, that is, an occluder that does not affect the puncture sheath passing through the atrial septum, including the left disc, right disc, and the waist between the left and right discs, the left disc and the right disc are respectively located on both sides of the foramen ovale on the interatrial septum; Space for the puncture sheath to be passed again through the interatrial septal region.

Preferably, the left disc, the right disc and the waist are respectively provided with choke films.

Preferably, the flow blocking film is set in a sheet shape and made of polymer materials or degradable materials.

Preferably, the occluder is made of a wire material with memory through integral braiding and then heat setting.

Preferably, the left disc, the right disc and the waist are provided with an integrated grid-like structure.

Preferably, the left disk and the right disk are configured as a double-layer grid-like structure.

Preferably, the surface of the outer side of the right disk is provided with a conveying part for the braiding wires to converge and connect.

Preferably, the conveying part is set as a steel wire sheath or coagulation ball, one end of the conveying part is connected with the braided wire, the other end of the conveying part is set as a free end, and the free end is provided with a occluder conveying system. The connection port for the connection.

Compared with the prior art, the present invention has the following beneficial effects:

The present invention maintains the structure and working principle of the traditional occluder, ensures the safe and effective use of the occluder, and sets the disk of the occluder in a long strip or oval shape, fully reserving enough space for the puncture sheath to pass through again. The space in the atrial septum area; while blocking the blood flow through the occluder, the reserved atrial septal area is easy to be punctured and expanded again, so that the puncture sheath can be easily punctured again from the reserved area around the occluder It is sent in, and the channel is reserved for the subsequent implementation of atrial septal puncture interventional surgery.

Description of drawings

Fig. 1 is a structural schematic diagram 1 of an existing occluder.

FIG. 2 is a second structural schematic diagram of an existing occluder.

Fig. 3 is a first schematic diagram of the structure of the occluder of the present invention.

Fig. 4 is a second schematic diagram of the structure of the occluder of the present invention.

Reference signs: 1. left disk; 2. right disk; 3. waist; 4. choke film; 5. conveying part.

detailed description

In order to make the present invention more obvious and understandable, the preferred embodiments are described in detail as follows in conjunction with the accompanying drawings:

As shown in Figure 3-4, the present invention provides a patent foramen ovale occluder that does not affect atrial septal puncture, that is, an occluder that fully reserves the puncture sheath to pass through the atrial septal area again, including the left disc 1, The waist 3 between the right disc 2 and the left and right discs, the left disc 1 and the right disc 2 are respectively located on both sides of the foramen ovale on the interatrial septum; This provides space for the puncture sheath to pass through the interatrial septal region again. The left disc 1 , the right disc 2 and the waist 3 are respectively provided with flow blocking films 4 . The flow blocking film 4 is set in a sheet shape and is made of polymer material or degradable material. The left plate 1, the right plate 2 and the waist 3 are made of memory silk material through integral weaving and then heat-set, and are set in an integrated grid-like structure. The left disc 1 and the right disc 2 are set as a double-layer grid-like structure. The outer surface of the right disc 2 is provided with a conveying part 5 for converging and connecting braided yarns. The conveying part 5 is set as a steel wire sheath or coagulation ball, one end of the conveying part 5 is connected with the braided wire, the other end of the conveying part 5 is set as a free end, and the free end is provided with a connection port connected with the occluder delivery system .

As shown in Figure 3-4, the present invention designs a patent foramen ovale occluder that does not affect atrial septal puncture, which includes a stent made of integrally braided wire with memory and then heat-set. Disk 1, right disk 2, and waist 3 are connected; the occluder also includes a flow-blocking membrane 4, which blocks the left disk 1, right disk 2, and waist 3 from the inside to ensure that the blood flow is blocked, thereby ensuring the foramen ovale The unoccluded closure is safe and effective; several braided wires in the center of the right disc 2 are converged and connected to the delivery part 5, realizing the connection between the occluder and the delivery system, so that the occluder can be pulled into or retracted into the delivery sheath. The occluder has a shape memory function, and has two forms: contraction and expansion. The contraction form is the strip-shaped delivery form in which the occluder is compressed into the sheath, and the expansion form is the double-disc and one-waist form after free stretching. The working form of "工" shape. Since the occluder has a shape memory feature, the occluder can automatically restore from the delivery state to the working state. The shape of the choke film 4 is sheet-like, which is made of polymer materials or degradable materials. The purpose of blocking the blood flow is achieved inside the disc 2 and the waist 3 . The left plate 1, right plate 2, and waist 3 are an integrated grid-like structure, which is made of wire material which is braided and heat-set. The wire material is a memory alloy material, preferably nickel-titanium alloy material, and the memory alloy material has a memory function. , so that the manufactured occluder bracket has shape memory, and can automatically return to the working shape from the delivery state, and the grid-like weaving of the waist is conducive to strengthening its supporting force and restoring the memory shape. The left disc 1 and the right disc 2 both have a double-layer grid-like structure. The double-layer structure helps to strengthen the supporting force of the disc-like structure, and the grid-like weaving is conducive to the restoration of the memory shape of the structure. The left disc 1 and the right disc 2 are distributed in a strip shape or an ellipse. On the premise of ensuring effective occlusion, a space is fully reserved for the puncture sheath to pass through the atrial septal region, ensuring that the sheath can pass through the atrial septum smoothly. The septum is thus entered into the left atrium to complete the puncture. The size of the left disk 1 is equal to that of the right disk 2, or smaller than the size of the right disk 2. The conveying part 5 is a steel wire sheath or coagulation ball, one end of the conveying part 5 is connected with the braided wire of the right disc 2, and the other end of the conveying part 5 is a free end, which is provided with a connection port and connected with the conveying system.

Example

Referring to Fig. 3, in a specific embodiment, a patent foramen ovale occluder that does not affect atrial septal puncture is designed, including a left disc 1, a right disc 2 and a waist 3 that has supported and connected the left and right discs, and the left disc 1 1. The right disk 2 is distributed in a long strip or oval shape, fully reserved space for the puncture sheath to pass through the atrial septum area again, ensuring that the puncture sheath can pass through the atrial septum area safely and easily into the left atrium, and the left disk 1 , right panel 2 and waist 3 are sewn with 1-4 layers of flow-blocking film 4 to block blood circulation from inside; flow-blocking film 4 can be coated with polyester film, polyurethane film, polytetrafluoroethylene film, etc. Made of any one of polymer materials, or made of degradable materials, its sheet shape is the same as the cross-sectional shape of the left disk 1, right disk 2, and waist 3. In this embodiment, the cross-sections of the left disk 1 and the right disk 2 are elliptical, so the flow blocking films of the left disk 1 and the right disk 2 are also oval, and the cross-section of the waist 3 is circular, so the waist resistance The flow membrane is also circular.

Referring to FIGS. 3-4 , the braided wire in the center of the right disc 2 converges on the conveying component 5 .

The left plate 1, right plate 2, and waist 3 are of an integrated grid-like structure, which is made of wire material which is braided and then heat-set. The wire material is a memory alloy material, preferably nickel-titanium alloy, so that the occluder has shape memory. It can be converted between contraction and expansion. The contraction form is the strip-shaped delivery form in which the occluder is compressed into the sheath, and the expansion form is the "working" with double discs and one waist after free extension. The working form of the glyph. Since the occluder has the feature of shape memory, it can automatically return to the working shape from the delivery shape, and the grid-like weaving of the waist is conducive to strengthening its supporting force and restoring the memory shape.

The left disc 1 and the right disc 2 both have a double-layer grid-like structure. The double-layer structure helps to strengthen the supporting force of the disc-like structure, and the grid-like weaving is conducive to the restoration of the memory shape of the structure.

The conveying part 5 is a wire steel sleeve or a coagulation ball. One end of the conveying part 5 is connected with the braided wire, and the other end of the conveying part 5 is a free end. The occluder is pulled into or pushed out of the delivery sheath as a whole.

In a specific embodiment, the waist of the occluder designed in this embodiment is a short waist, the length is only 4 mm, and the diameter of the waist is about 5 mm.

The length of the elongated or elliptical disk designed by the present invention is consistent with that of the prior art, but the width of the disk is greatly reduced. In the specific embodiment, the length of the disk surface is set at about 25 mm, which is basically the same as the diameter of the disk surface of the existing occluder, ensuring the safety and effectiveness of foramen ovale closure; while the width of the disk surface is reduced to about 6 mm, fully reserved for puncture The sheath is again threaded through the interatrial septal space, thereby ensuring that the puncture sheath can be safely and easily passed through the interatrial septum into the left atrium.

The occluder designed by the present invention has many models, for example, the specifications are divided according to different waist diameters. In use, the suitable model can be selected according to the situation of the patent foramen ovale. At the same time, the elongated or elliptical disc surface of the present invention also significantly reduces the difficulty of puncturing the reserved puncture channel, and enhances the success rate of subsequent atrial septal puncture interventional operations.

In a specific embodiment, the present invention maintains the traditional structure and working principle of double disks and one waist, ensuring the safety and effectiveness of the occluder; at the same time, the occluder is designed as a strip or ellipse, and the left and right The discs with the same disc size block the blood flow through the occluder, and at the same time fully reserve the space for the puncture sheath to pass through the interatrial septal area, making the puncture sheath easy to puncture and expand, making it easier to puncture from the occluder It is very easy to put the sheath into the reserved area around the device. While achieving safe and effective treatment of the patent foramen ovale, the present invention reserves a channel for the subsequent interventional operation of transseptal puncture, and keeps the opportunity for patients to perform minimally invasive interventional operation of the atrial septum.

The foregoing is only a preferred embodiment of the present invention, and is not intended to limit the present invention in any form and in essence. Several improvements and supplements are made, and these improvements and supplements should also be regarded as the protection scope of the present invention. Those who are familiar with this profession, without departing from the spirit and scope of the present invention, when they can use the technical content disclosed above to make some changes, modifications and equivalent changes of evolution, are all included in the present invention. Equivalent embodiments; at the same time, all changes, modifications and evolutions of any equivalent changes made to the above-mentioned embodiments according to the substantive technology of the present invention still belong to the scope of the technical solution of the present invention.

Claims (8)

1. A patent foramen ovale plugging device which does not affect atrial septal puncture, namely a plugging device which fully reserves a puncture sheath and passes through an atrial septal region again, comprises a left disc, a right disc and a waist part between the left disc and the right disc, wherein the left disc and the right disc are respectively positioned at two sides of a foramen ovale on the atrial septal; the method is characterized in that: the left disc and the right disc are made into long strips or ellipses, and a space for the puncture sheath tube to pass through the atrial septal region again is fully reserved.

2. The patent foramen ovale occluder without affecting atrial septal puncture of claim 1, wherein: and the left disc, the right disc and the waist are respectively provided with a flow resistance film.

3. The patent foramen ovale occluder without affecting atrial septal puncture in claim 2, wherein: the flow resisting film is sheet and is made of high polymer material or degradable material.

4. The patent foramen ovale occluder without affecting atrial septal puncture of claim 3, wherein: the left disc, the right disc and the waist part of the plugging device are made of memory wire materials through integrated weaving and then heat setting.

5. The patent foramen ovale occluder without affecting atrial septal puncture of claim 4, wherein: the left disc, the right disc and the waist are of an integrated grid-like structure.

6. The patent foramen ovale occluder without affecting atrial septal puncture in claim 5, wherein: the left disc and the right disc are of double-layer grid-like structures.

7. The patent foramen ovale occluder without affecting atrial septal puncture of claim 6, wherein: and a conveying component for convergence and connection of the braided wires is arranged on the surface of the outer side of the right disc.

8. The patent foramen ovale occluder without affecting atrial septal puncture of claim 7, wherein: the conveying component is a wire-clamping steel sleeve or a coagulating sphere, one end of the conveying component is connected with the braided wire, the other end of the conveying component is a free end, and the free end is provided with a connecting port connected with the occluder conveying system.

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