CN112089453A

CN112089453A - Patent foramen ovale plugging device

Info

Publication number: CN112089453A
Application number: CN201910527911.2A
Authority: CN
Inventors: 李�瑞; 赵天力; 白云; 赵丹儒; 闫伟
Original assignee: Shanghai Push Medical Device Technology Co ltd
Current assignee: Shanghai Push Medical Device Technology Co ltd
Priority date: 2019-06-18
Filing date: 2019-06-18
Publication date: 2020-12-18

Abstract

The invention provides a patent foramen ovale occluder, which comprises a left disc, a right disc, a waist part connected between the left disc and the right disc, a left anchoring valve part connected on the left disc in a multi-valve manner, and a right anchoring valve part connected on the right disc in a multi-valve manner; the outer end of the left anchoring flap part extends out of the left disc, and a first empty area which is communicated from left to right is formed in the left anchoring flap part and between the two adjacent left anchoring flap parts; the outer end of the right anchoring petal part extends outwards from the right disc, and a second empty area which is communicated from left to right is formed in the right anchoring petal part and between the two adjacent right anchoring petal parts. The disc areas of the left disc and the right disc are reduced by more than 80% through the left anchoring valve part and the right anchoring valve part, and complications such as blood vessel abrasion and the like are avoided; and then, by combining the first dead zone and the second dead zone of the patent foramen ovale occluder, a puncture space is reserved for future atrial septal puncture, which is favorable for future operations.

Description

Patent foramen ovale plugging device

Technical Field

The invention relates to the field of medical instruments, in particular to a patent foramen ovale occluder used for interventional operation treatment.

Background

Patent Foramen Ovale (PFO) is the most common congenital heart abnormality in adults, and 1 in about 4 of the normal population is detected. 150 million patients with congenital heart disease exist in China, the morbidity of the congenital heart disease is 6.78% every year, up to 10-15 thousands of infants suffering from the congenital heart disease are born every year, and the patent number of a single foramen ovale accounts for about 10% of the congenital heart disease.

The oval hole is formed in the growth and development process of a fetus, when the embryo develops to the 6 th-7 th week, two intervals develop in sequence in the atrial interval, and the interval appearing first is the primary interval or the first interval. The primary septum grows in a half moon shape from the midline dorsal sidewall of the atrium, grows towards the atrioventricular tube, fuses with the endocardial pad, and leaves a small hole at the tail end of the atrial septum to form a primary hole. Before the primary opening is not closed, a hole is formed at the part of the primary hair near the head end, called a secondary opening, and is a normal blood channel in the fetal period. Meanwhile, a sickle-shaped septum is grown on the right side of the first side from the atrial wall and is called a second septum or a secondary septum, the secondary septum also grows towards the endocardium to cover the secondary hole but is not fused with the endocardial pad, but is sunken to form an oval shape called an oval fossa, and a small gap which is not bonded and fused between the primary septum and the secondary septum at the oval fossa is called an oval hole. The patent refers to the field of 'fetal health'.

Patent foramen ovale, a common problem, can lead to potentially serious complications. Many studies in recent years have shown that patent foramen ovale is closely related to stroke patients of unknown origin. For patent with patent foramen ovale, the remaining slit-like abnormal channels of the primary compartment and the secondary compartment are similar to a functional valve, and because the blood pressure in the left atrium of the heart is higher than that in the right atrium, the blood can flow from the left atrium to the right atrium through the patent foramen ovale, and the long-term left atrium flows to the right atrium, so that the blood volume in the right atrium is increased, the right ventricle is enlarged, and the lung circulation blood volume is increased. When right atrial pressure is higher than left atrial pressure, the weak primary septum on the left side is pushed open, and right-to-left shunting of blood occurs. The following emboli may enter the left cardiac system causing the corresponding clinical symptoms: 1. thrombosis of the deep veins or pelvic veins of the lower limbs; 2. air emboli resulting from caisson's disease or decompression sickness; 3. fatty emboli formed after surgery or trauma. The risk of recurrence remains high for patent foramen ovales with thrombotic episodes. Meanwhile, the long-term existence of patent foramen ovale is also found to cause symptoms such as migraine, cerebral ischemia, cerebral apoplexy, decompression sickness, decubitus respiratory upright hypoxia syndrome, altitude sickness and the like.

The traditional treatment mode of the patent foramen ovale is surgical operation. The treatment method of surgery is that the patient needs to be opened by surgery. The main drawbacks of surgery are: 1. extracorporeal circulation is needed during the operation, which may cause complications and death; 2. the surgical operation has large wound and scars are left after the operation; 3. the surgery is expensive.

With the development and improvement of interventional therapy technology, methods for treating PFO through minimally invasive interventional techniques are now well established. The minimally invasive interventional therapy has the advantages of no operation, small wound, less complication, quick recovery, good effect, wide range of indications, relatively low operation cost and the like. The current mainstream product in clinical practice is a traditional double-disc foramen ovale stopper, as shown in fig. 1, the traditional double-disc foramen ovale stopper has a double-disc structure, and comprises a left disc 100 and a right disc 200 which are bilaterally symmetrical, and a short waist part 300 connected between the left disc 100 and the right disc 200, wherein a protruding gathering end 400 is arranged in the middle of the left side of the left disc 100, and a protruding gathering end 400 is arranged in the middle of the right side of the right disc 200. However, the above-mentioned conventional double-disc foramen ovale occluder has more or less problems in clinical use.

1. If the oval hole is close to the superior and inferior vena cava or the main pulmonary artery, the edge of the occluder can abrade the blood vessel, resulting in failure of occlusion; if the occluder with the small disk surface size of the left disk 100 and the right disk 200 is selected, the anchoring effect of the occluder is poor, and the occlusion stability is poor.

2. The fossa ovalis is a puncture point for atrial septal puncture in a cardiac interventional operation, and for patent patients with potential patent foramen ovale interventional cardiac therapy, after the patent foramen ovale is plugged by the traditional plugging device, the situation that interventional therapy cannot be adopted due to difficult atrial septal puncture and a higher risk treatment method is used can be met.

Disclosure of Invention

In view of the above-mentioned drawbacks of the prior art, the present invention aims to provide a patent foramen ovale occluder which can avoid abrasion of blood vessels while ensuring anchoring effect, while preserving future atrial septal puncture possibilities.

In order to achieve the purpose, the invention provides a patent foramen ovale occluder, which comprises a left disc, a right disc, a waist part connected between the left disc and the right disc, a left anchoring flap part connected on the left disc in a multi-flap way, and a right anchoring flap part connected on the right disc in a multi-flap way; the outer end of the left anchoring petal part extends outwards out of the left disc, and a first empty area which is communicated from left to right is formed in the left anchoring petal part and between the two adjacent left anchoring petals; the outer end of the right anchoring petal part extends outwards from the right disc, and a second empty area which is communicated from left to right is formed in the right anchoring petal part and between the right anchoring petal parts of two adjacent petals.

Furthermore, the left disc and the right disc are all formed by weaving elastic metal wires, and the left anchoring flap portion and the right anchoring flap portion are formed by bending the elastic metal wires.

Further, the elastic metal wire is a nickel-titanium alloy metal wire.

Further, the patent foramen ovale occluder further comprises a near-end rivet sleeve, the waist is a constraint sleeve, the far-end face of the left disc is a flat face, the near end of the left disc is constrained and fixed by the waist, the far end of the right disc is constrained and fixed by the waist, and the near end of the right disc is constrained and fixed by the near-end rivet sleeve.

Further, the root of the left anchoring flap part is restrained and fixed in the waist part towards the proximal direction, and the root of the right anchoring flap part is restrained and fixed in the proximal rivet sleeve towards the proximal direction; and after the patent foramen ovale occluder is put into a conveying device, the left anchoring valve part and the right anchoring valve part are folded into a linear shape.

Further, the wire diameter of the elastic metal wire adopted by the left disc and the right disc is 0.1mm, and the wire diameter of the elastic metal wire adopted by the left anchoring flap part and the right anchoring flap part is 0.2 mm.

Further, the left and right anchoring petals are petal-shaped.

Further, the disc surface diameters R of the left disc and the right disc are both 12-20mm, the longest distance L1 between the left anchoring flap part and the center of the left disc is 9-15mm, and the longest distance L2 between the right anchoring flap part and the center of the right disc is 9-15 mm.

Further, the left and right anchoring petals each have 4 petals.

Further, the patent foramen ovale occluder also comprises a blood flow blocking film for blocking blood flow, and the blood flow blocking film is flatly fixed in the left disc and the right disc.

As described above, the patent foramen ovale occluder according to the present invention has the following beneficial effects:

in the application, the left anchoring valve part and the right anchoring valve part enable the patent foramen ovale occluder to reduce the disc area of the left disc and the right disc by more than 80% on the premise of ensuring the anchoring effect, so that the left disc and the right disc are prevented from wearing blood vessels, the volume of the occluder after stretching in the delivery process is reduced due to the reduction of the disc surface, the adaptive delivery system has smaller specification, and the occluder delivery system is prevented from potentially damaging blood vessels of a human body; in the implantation process of the patent foramen ovale occluder, the orientation of the left anchoring valve part and the orientation of the right anchoring valve part can be adjusted by rotating the patent foramen ovale occluder, and the abrasion of blood vessels on the outer edges (namely the left anchoring valve part and the right anchoring valve part) of the patent foramen ovale occluder is avoided, so that the blood vessels can be well avoided on the premise of ensuring the anchoring effect of the patent foramen ovale occluder, the abrasion of the blood vessels is avoided, and the occlusion effect is ensured. Particularly, the disc areas of the left disc and the right disc are reduced by more than 80%, and the puncture space is reserved for future atrial septal puncture by combining the first empty area and the second empty area of the patent foramen ovale occluder, so that future operations are facilitated.

Drawings

Figure 1 is a schematic illustration of the occlusion of a foramen ovale using a conventional double-disc foramen ovale occluder.

Fig. 2 is a schematic structural diagram of the patent foramen ovale occluder in the present application.

Fig. 3 is a front view of fig. 2.

Fig. 4 is a view taken along direction a of fig. 3.

Fig. 5 is a view from direction B of fig. 3.

Fig. 6 is a schematic view of the patent foramen ovale occluder of the present application fully retracted into the sheath.

Fig. 7 and 8 are schematic views illustrating the state that the patent foramen ovale occluder is partially released from the sheath in the present application.

Figure 9 is a schematic view of the patent foramen ovale closure using the patent foramen ovale closure device of the present application.

Description of the element reference numerals

1 left dish

2 Right dish

3 waist part

4 left anchoring flap part

5 Right anchoring flap

6 first dead zone

7 second vacant area

8 near-end rivet sleeve

9 sheath pipe

10 push rod

Detailed Description

The following description of the embodiments of the present invention is provided for illustrative purposes, and other advantages and effects of the present invention will become apparent to those skilled in the art from the present disclosure.

It should be understood that the structures, proportions, and dimensions shown in the drawings and described herein are for illustrative purposes only and are not intended to limit the scope of the present invention, which is defined by the claims, but rather by the claims. In addition, the terms such as "upper", "lower", "left", "right", "middle" and "one" used in the present specification are for convenience of description only and are not intended to limit the scope of the present invention, and changes or modifications of the relative relationship thereof may be made without substantial technical changes and modifications.

As shown in fig. 2 to 5, the present application provides a patent foramen ovale occluder, which includes a left disc 1, a right disc 2, a waist portion 3 connected between the left disc 1 and the right disc 2, a left anchoring flap portion 4 connected to the left disc 1 in a multi-flap manner, and a right anchoring flap portion 5 connected to the right disc 2 in a multi-flap manner, wherein the left disc 1 and the right disc 2 are respectively distributed at a distal end and a proximal end of the patent foramen ovale occluder, the distal end is an end of the patent foramen ovale occluder away from an operator, the proximal end is an end of the patent foramen ovale occluder close to the operator, or in the view shown in fig. 3, the left side of the paper surface is the proximal end of the patent foramen ovale occluder, and the right side of the paper surface is the distal end of the. Further, as shown in fig. 3 and 4, the outer end of the left anchoring flap portion 4 extends outward beyond the left disc 1, so that at least a part of the left anchoring flap portion 4 is located on the outer peripheral side of the left disc 1, and a first empty space 6 passing through the left and right is formed in the left anchoring flap portion 4 and between the adjacent two left anchoring flap portions 4. As shown in fig. 3 and 5, the outer end of the right anchoring flap portion 5 extends outward beyond the right disc 2, so that at least a part of the right anchoring flap portion 5 is located on the outer peripheral side of the right disc 2, and a second empty space 7 penetrating left and right is provided in the right anchoring flap portion 5 and between the right anchoring flap portions 5 of two adjacent flaps.

After the patent foramen ovale occluder is implanted into a human body through a conveying device, the patent foramen ovale is anchored through the left disc 1, the right disc 2, the waist 3, the left anchoring flap part 4 and the right anchoring flap part 5, and the patent foramen ovale is occluded, as shown in fig. 9. The left anchoring valve part 4 and the right anchoring valve part 5 increase the contact area between the patent foramen ovale occluder and the atrial septum, and reduce the disc area of the left disc 1 and the right disc 2 to the maximum extent on the premise of reliably anchoring the patent foramen ovale occluder at the patent foramen ovale, so that the disc area of the left disc 1 and the right disc 2 can be reduced by more than 80 percent, and the left disc 1 and the right disc 2 are prevented from wearing blood vessels; in the anchoring process after the patent foramen ovale occluder is implanted into a human body, the patent foramen ovale occluder can be rotated by the pushing rod 10, and then the orientations of the left anchoring flap part 4 and the right anchoring flap part 5 are adjusted, so that the first dead zone 6 between the two adjacent left anchoring flap parts 4 and the second dead zone 7 between the two adjacent right anchoring flap parts 5 face blood vessels, that is, the outer edges of the patent foramen ovale occluder (namely the left anchoring flap part 4 and the right anchoring flap part 5) are prevented from wearing the blood vessels, and therefore the patent foramen ovale occluder can be well prevented from being worn by the blood vessels on the premise of ensuring the anchoring effect of the patent foramen ovale occluder, the blood vessels are prevented from being worn, and the occlusion effect is ensured. The reduction of the area of the left disc 1 and the right disc 2 can also reduce the volume of the patent foramen ovale occluder, thereby reducing the size of the conveying device, reducing the potential injury of the conveying device to blood vessels of a human body, and particularly reducing the blood vessel injury of patients with low age such as babies. Particularly, the disc areas of the left disc 1 and the right disc 2 are reduced by more than 80%, and the first empty area 6 in the left anchoring flap part 4, the first empty area 6 between two adjacent left anchoring flap parts 4, the second empty area 7 in the right anchoring flap part 5 and the second empty area 7 between two adjacent right anchoring flap parts 5 are combined to reserve a puncture space for future atrial septal puncture, so that future surgery is facilitated. Therefore, the patent foramen ovale plugging device related to the application can guarantee anchoring and plugging effects, can avoid abrasion of blood vessels, and can keep atrial septal puncture possibility after plugging of the patent foramen ovale, thereby being beneficial to improving effectiveness and safety of interventional therapy of the patent foramen ovale of the heart and considering requirements of puncture of future rooms.

Preferably, in the present application, as shown in fig. 4 and 5, the disc surface diameters R of the left and

right discs

1 and 2 are 12 to 20mm, the longest distance L1 between the left anchoring flap 4 and the center of the left disc 1 is 9 to 15mm, the longest distance L2 between the right anchoring flap 5 and the center of the right disc 2 is 9 to 15mm, the widest width W1 of the left anchoring flap 4 is 6 to 12mm, and the widest width W2 of the right anchoring flap 5 is 6 to 12 mm.

As shown in fig. 2 to 5, the left disc 1 and the right disc 2 are both woven from elastic metal wires, the main bodies of the left disc 1 and the right disc 2 are of a flat cylinder disc structure, and the left anchoring flap portion 4 and the right anchoring flap portion 5 are both formed by bending the elastic metal wires, so that the left disc 1, the right disc 2, the left anchoring flap portion 4 and the right anchoring flap portion 5 have a self-expanding function, so that the patent foramen ovale occluder can be completely collected into a delivery device, and can be restored to the original form after being released from the delivery device. Preferably, the elastic metal wires that weave the left and

right discs

1 and 2, and the elastic metal wires that constitute the left and right anchoring

flap portions

4 and 5, are all nickel titanium alloy wires; the nickel-titanium alloy wire is a shape memory alloy, and the shape memory alloy is a special alloy which can automatically restore the self plastic deformation to the original shape at a certain specific temperature; the expansion and contraction rate is more than 20%, the fatigue life is extremely long, the damping characteristic is 10 times higher than that of a common spring, and the corrosion resistance of the spring is superior to that of the best medical stainless steel at present, so that the spring can meet the application requirements of various engineering and medicine, and is a very excellent functional material. In addition, the wire diameters of the elastic wires (i.e., nickel-titanium alloy wires) used for the left and

right discs

1 and 2 are 0.1mm, and the wire diameters of the elastic wires (i.e., nickel-titanium alloy wires) used for the left and right anchoring

flap portions

4 and 5 are 0.2 mm.

As shown in fig. 3 and 4, 4 left anchoring flap portions 4 are uniformly distributed on the outer periphery of the left disc 1, each left anchoring flap portion 4 is tightly attached to the proximal end surface of the left disc 1 and extends outwards along the radial direction of the left disc 1, and the included angle between the center lines of the left anchoring flap portions 4 of two adjacent flaps is 90 degrees; each left anchoring flap portion 4 is petal-shaped, and the left anchoring flap portion 4 causes the left disc 1 to have petal-shaped edges, so that the patent foramen ovale occluder shown in fig. 4 is in a flower-like structure; there may be a partial intersection between the roots of two adjacent left anchoring petals 4. Similarly, as shown in fig. 3 and 5, 4 right anchoring flap portions 5 are uniformly distributed on the outer periphery of the right disc 2, each right anchoring flap portion 5 is tightly attached to the proximal end face of the right disc 2 and extends outwards along the radial direction of the right disc 2, and the included angle between the center lines of the right anchoring flap portions 5 of two adjacent flaps is 90 degrees; each right anchoring flap portion 5 is petal-shaped, and the right anchoring flap portion 5 causes the right disc 2 to have a petal-shaped edge, so that the patent foramen ovale occluder shown in fig. 5 is in a flower-like structure; there may be a partial intersection between the roots of two adjacent right anchoring petals 5. In addition, in this application, left disc 1 and right disc 2 are parallel, and left anchor lamella portion 4 and right anchor lamella portion 5 symmetric distribution, and left anchor lamella portion 4 and right anchor lamella portion 5 both's structural dimension and the position of arranging are the same.

Furthermore, the patent foramen ovale occluder also comprises a blood flow blocking film which is flatly sewn and fixed in the left disc 1 and the right disc 2 to play a role in blocking horizontal blood flow. Preferably, the blood flow blocking membrane is polyester fiber non-woven fabric, and the polyester fiber non-woven fabric has good wrinkle resistance and shape retention, high strength and high elastic recovery capacity, and guarantees the effect of blocking blood flow, so that the blocking effect of the patent foramen ovale blocking device is guaranteed. The blood flow blocking film arranged in the left disc 1 and the right disc 2 can be a layer or a plurality of layers.

As shown in fig. 2 and 3, the patent foramen ovale occluder further comprises a proximal rivet sleeve 8, the waist 3 is a restraining sleeve made of metal, the distal end face of the left disc 1 is a flat face, the proximal end is restrained and fixed by the waist 3, the distal end of the right disc 2 is restrained and fixed by the waist 3, and the proximal end is restrained and fixed by the proximal rivet sleeve 8. Therefore, the patent foramen ovale occluder in the application is a structure with a single rivet at the near end and a rivet-free rivet at the far end, or the left disc 1 adopts a rivet-free design and the far end of the left disc 1 has a rivet-free point, so that endothelial cells can climb to the left disc, the endothelialization time is reduced, and meanwhile blood climbing and thrombosis possibility can be avoided.

Further, as shown in fig. 3, in knitting the patent foramen ovale occluder, the elastic wires constituting the left anchoring flap portion 4 are restrained and fixed in the waist portion 3 together with the elastic wires knitting the left disc 1, that is: the root of the left anchoring flap part 4 is constrained and fixed in the waist part 3 towards the proximal direction; the elastic wires that make up the right anchoring flap 5 are constrained together with the elastic wires that weave the right disc 2, fixed in the proximal rivet head sleeve 8, namely: the root of the right anchoring flap 5 is constrained and fixed in the proximal rivet sleeve 8 in the proximal direction. Therefore, in the process of taking the patent foramen ovale occluder into the delivery device, as shown in fig. 6, the left anchoring flap portion 4 and the right anchoring flap portion 5 are folded into a linear shape once stretched and taken into the delivery device in a linear shape; when the patent foramen ovale occluder is released from the delivery device at the lesion site, as shown in fig. 8, the left and right anchoring

petals

4 and 5 return to their original shape and assume a petal shape, so that the patent foramen ovale occluder assumes a flower shape both when viewed from the proximal side and when viewed from the distal side.

Preferably, the constraining sheath and the proximal rivet sheath 8 constituting the waist 3 both comprise an inner steel sheath and an outer steel sheath fixedly connected, and the ends of the plurality of elastic wires weaving the left disc 1 and the roots of the elastic wires constituting the left anchoring flap portion 4 may be fixed between the inner steel sheath and the outer steel sheath of the waist 3, or may be fixed in the inner steel sheath of the waist 3 with tight fit; similarly, the far ends of the plurality of elastic metal wires for weaving the right disc 2 can be fixed between the inner steel sleeve and the outer steel sleeve of the waist 3, and also can be fixed in the inner steel sleeve of the waist 3 in a tight fit manner; the proximal ends of the plurality of elastic wires that weave the right disc 2 and the roots of the elastic wires that constitute the right anchoring flap portion 5 may be fixed between the inner and outer steel sleeves of the proximal rivet head sleeve 8, or may be fixed in the inner steel sleeve of the proximal rivet head sleeve 8 with tight fit.

Furthermore, the inner wall of the near end of the outer steel sleeve of the near-end rivet sleeve 8 is provided with connecting threads for connecting with a pushing rod 10 in the conveying device, so that the conveying device is detachably connected with the patent foramen ovale plugging device. Preferably, as shown in fig. 3, the outer wall of the outer steel sleeve of the proximal rivet sleeve 8 is frustum-shaped, that is: the outer diameter of the outer steel sleeve of the proximal rivet sleeve 8 gradually decreases in the distal-to-proximal direction.

Preferably, as shown in fig. 6 to 8, the delivery device for delivering the patent foramen ovale occluder in the present application comprises a sheath 9 and a push rod 10, the push rod 10 is movably and rotatably disposed in the sheath 9, and the push rod 10 can be a thin rod or a steel cable.

The operation of pulling the patent foramen ovale occluder of the above-described structure into the sheath 9 of the delivery device is as follows: as shown in fig. 6, the distal end of the pushing rod 10 is connected to the proximal end of the proximal rivet sleeve 8 of the patent foramen ovale occluder, and when the pushing rod 10 is pulled to move the pushing rod 10 toward the operator, the pushing rod 10 drives the patent foramen ovale occluder to move synchronously toward the operator until the patent foramen ovale occluder is completely pulled into the sheath 9. In the process that the patent foramen ovale occluder is gradually pulled into the sheath 9, the proximal end of the right disc 2 firstly enters the sheath 9, and then the right anchoring flap part 5 and the right disc 2 start to deform from the proximal end to the distal end and are gradually stretched into a straight line to enter the sheath 9; then, the waist 3 is pulled into the sheath 9; finally, the left anchoring flap 4 and the left disc 1 start to deform from the proximal end to the distal end and are gradually stretched into a straight line and enter the sheath 9. Therefore, the patent foramen ovale occluder is housed in a sheath 9 of the delivery device in a straight line as a whole.

The specific operation of implanting the patent foramen ovale occluder into a patient by adopting the conveying device is as follows: as shown in fig. 7 and 8, in a state where the pushing rod 10 is connected to the proximal end of the patent foramen ovale occluder, the pushing rod 10 is pushed to move the pushing rod 10 in a direction away from the operator, and the pushing rod 10 drives the patent foramen ovale occluder to move synchronously in the direction away from the operator until the patent foramen ovale occluder is completely released from the sheath 9. In the process that the patent foramen ovale occluder is released from the sheath 9, the outer end of the left anchoring flap part 4 is firstly released from the sheath 9, then the distal end of the left disc 1 is released, under the action of the self-resilience force of the elastic metal wire, the left disc 1 and the left anchoring flap part 4 are restored to respective original shapes from a straight line shape, and the original shapes are preset expansion shapes when not being accommodated in the sheath 9; thereafter, the waist 3 is released from the sheath 9; finally, the right disc 2 and the right anchoring flap part 5 are released from the sheath 9 and restored to their original shapes, so that the patent foramen ovale occluder is entirely released from the sheath 9 and restored to a preset expanded shape; at this time, as shown in fig. 9, the patent foramen ovale occluder is fixed at the patent foramen ovale, and implantation and occlusion are realized.

In conclusion, the present invention effectively overcomes various disadvantages of the prior art and has high industrial utilization value.

The foregoing embodiments are merely illustrative of the principles and utilities of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical spirit of the present invention be covered by the claims of the present invention.

Claims

1. The patent foramen ovale occluder comprises a left disc (1), a right disc (2) and a waist part (3) connected between the left disc (1) and the right disc (2), and is characterized in that: the multi-valve anchoring disc also comprises a left anchoring valve part (4) connected to the left disc (1) in a multi-valve manner and a right anchoring valve part (5) connected to the right disc (2) in a multi-valve manner; the outer end of the left anchoring petal part (4) extends outwards out of the left disc (1), and a left empty area (6) which is communicated with the left and the right is arranged in the left anchoring petal part (4) and between the two adjacent left anchoring petals (4); the outer end of the right anchoring petal part (5) extends out of the right disc (2), and a second empty area (7) which is communicated from left to right is formed in the right anchoring petal part (5) and between the two adjacent right anchoring petal parts (5).

2. The patent foramen ovale occluder of claim 1, wherein: the left disc (1) and the right disc (2) are all formed by weaving elastic metal wires, and the left anchoring flap part (4) and the right anchoring flap part (5) are formed by bending the elastic metal wires.

3. The patent foramen ovale occluder of claim 2, wherein: the elastic metal wire is a nickel-titanium alloy metal wire.

4. The patent foramen ovale occluder of claim 2, wherein: still include near-end rivet head cover (8), waist (3) are the restraint cover, the distal end face of left side dish (1) is the planishing face, the near-end is fixed by waist (3) restraint, the distal end of right side dish (2) is fixed by waist (3) restraint, the near-end is fixed by near-end rivet head cover (8) restraint.

5. The patent foramen ovale occluder of claim 4, wherein: the root of the left anchoring flap part (4) is constrained and fixed in the waist part (3) towards the proximal direction, and the root of the right anchoring flap part (5) is constrained and fixed in the proximal rivet sleeve (8) towards the proximal direction; when the patent foramen ovale occluder is put into a conveying device, the left anchoring flap part (4) and the right anchoring flap part (5) are folded into a linear shape.

6. The patent foramen ovale occluder of claim 2, wherein: the wire diameter of the elastic metal wire adopted by the left disc (1) and the right disc (2) is 0.1mm, and the wire diameter of the elastic metal wire adopted by the left anchoring flap part (4) and the right anchoring flap part (5) is 0.2 mm.

7. The patent foramen ovale occluder of claim 1 or 2, wherein: the left anchoring petal part (4) and the right anchoring petal part (5) are in petal shapes.

8. The patent foramen ovale occluder of claim 1 or 2, wherein: the disc surface diameter R of the left disc (1) and the right disc (2) is 12-20mm, the longest distance L1 between the left anchoring flap part (4) and the center of the left disc (1) is 9-15mm, and the longest distance L2 between the right anchoring flap part (5) and the center of the right disc (2) is 9-15 mm.

9. The patent foramen ovale occluder of claim 1 or 2, wherein: the left anchoring flap portion (4) and the right anchoring flap portion (5) both have 4 flaps.

10. The patent foramen ovale occluder of claim 1 or 2, wherein: the blood flow blocking device further comprises a blood flow blocking film for blocking blood flow, and the blood flow blocking film is flatly fixed in the left disc (1) and the right disc (2).