Patent foramen ovale occluder

Abstract

The present invention provides a patent foramen ovale occluder, comprising a left disc, a right disc, a waist connected between the left disc and the right disc, a left anchoring flap part with multiple flaps connected to the left disc, and a right anchoring flap part with multiple flaps connected to the right disc; the outer end of the left anchoring flap part extends outward from the left disc, and the left anchoring flap part and the left anchoring flap parts of two adjacent flaps have a first empty area that runs through the left and right sides; the outer end of the right anchoring flap part extends outward from the right disc, and the right anchoring flap part and the right anchoring flap parts of two adjacent flaps have a second empty area that runs through the left and right sides. The left anchoring flap part and the right anchoring flap part can reduce the disc area of ​​the left and right discs by more than 80%, avoiding complications such as abrasion of blood vessels; combined with the first empty area and the second empty area of ​​the patent foramen ovale occluder, a puncture space is reserved for future atrial septal puncture, which is beneficial to future surgery.

Description

Technical Field

[0001] The invention relates to the field of medical devices, and in particular to a patent foramen ovale occluder used in interventional surgery. Background Art

[0002] Patent Foramen Oval (PFO) is the most common congenital heart anomaly in adults. In the normal population, about 1 in 4 people can be found to have this disease. There are 1.5 million patients with congenital heart disease in my country, and the annual prevalence of congenital heart disease is 6.78%. There are as many as 100,000 to 150,000 newborns with congenital heart disease each year, of which simple patent foramen ovale accounts for about 10% of congenital heart disease.

[0003] The foramen ovale is formed during the growth and development of the fetus. When the embryo develops to the 6th-7th week, two septa develop in the atrial septum. The first septum is the primary septum or the first septum. The primary septum grows from the dorsal wall of the atrial midline in a semilunar shape, grows toward the atrioventricular canal and fuses with the endocardial cushion, leaving a small hole at the end of the atrial septum, which becomes the primary foramen. Before the primary foramen is closed, a hole is formed near the head of the primary septum, called the secondary foramen, which is the normal blood channel during the fetal period. At the same time, a sickle-shaped septum grows from the atrial wall on the right side of the first side, called the second septum or secondary septum. The secondary septum also grows toward the endocardium, covering the secondary foramen, but does not fuse with the endocardial cushion, but is concave to form an oval shape called the oval fossa. The small crack between the primary septum and the secondary septum at the oval fossa that fails to adhere and fuse is called the oval foramen. The oval foramen is generally closed within one year after the fetus is born. If the oval foramen of a child older than three years old is still not closed, it is called a patent foramen ovale.

[0004] Patent foramen ovale is a common problem that may lead to potentially serious complications. Many studies in recent years have shown that there is a close connection between patent foramen ovale and patients with unexplained stroke. For patients with patent foramen ovale, the residual slit-like abnormal channel between the primary septum and the secondary septum is similar to a functional valve. Since the blood pressure in the left atrium of the heart is higher than that in the right atrium, blood may flow from the left atrium to the right atrium through the foramen ovale. Long-term blood flow from the left atrium to the right atrium leads to an increase in the blood volume of the right atrium, causing right ventricular hypertrophy and increased pulmonary circulation blood volume. When the right atrial pressure is higher than the left atrial pressure, the weak primary septum on the left side is pushed open, and blood shunts from right to left. The following emboli may enter the left heart system and cause corresponding clinical symptoms: 1. Thrombosis of the deep veins of the lower limbs or pelvic veins; 2. Air emboli caused by diving sickness or decompression sickness; 3. Fat emboli formed after surgery or trauma. For patients with patent foramen ovale who have experienced thrombotic events, the risk of recurrence is still very high. At the same time, it has been found that the long-term presence of patent foramen ovale can cause migraine, cerebral ischemia, stroke, decompression sickness, supine orthostatic hypoxia syndrome and altitude sickness.

[0005] The traditional treatment for patent foramen ovale is surgery. For surgical treatment, the patient needs to undergo a thoracotomy. The main disadvantages of surgery are: 1. Extracorporeal circulation is required during the operation, and the operation may cause complications and lead to death; 2. Surgery is very traumatic and leaves scars after the operation; 3. The cost of surgery is expensive.

[0006] With the development and improvement of interventional treatment technology, the method of treating PFO through minimally invasive interventional technology is now very mature. Minimally invasive interventional treatment has the advantages of no surgery, less trauma, fewer complications, faster recovery, better results, a wide range of indications and relatively low surgical costs. The mainstream product in clinical practice is the traditional double-disc foramen ovale occluder, such as Figure 1 As shown, the conventional double-disc foramen ovale occluder is a double-disc structure, comprising a left disk 100 and a right disk 200 that are symmetrical, and a short waist 300 connected between the left disk 100 and the right disk 200, and a protruding collection end 400 at the middle of the left side of the left disk 100, and a protruding collection end 400 at the middle of the right side of the right disk 200. However, the conventional double-disc foramen ovale occluder has more or less problems in clinical use.

[0007] 1. If the foramen ovale is close to the superior or inferior vena cava or the main pulmonary artery, the edge of the occluder may wear the blood vessels, resulting in occlusion failure; if an occluder with a smaller disk size of 100 on the left or 200 on the right is selected, the anchoring effect of the occluder is poor, resulting in poor occlusion stability.

[0008] 2. The fossa ovale is the puncture point for atrial septal puncture during cardiac interventional surgery. For patients with patent foramen ovale who have potential for interventional cardiac treatment, after occluding the foramen ovale with the above-mentioned traditional occluder, they will face the situation where they cannot use interventional treatment due to the difficulty in performing atrial septal puncture, and have to switch to a more risky treatment method. Summary of the invention

[0009] In view of the above-mentioned shortcomings of the prior art, an object of the present invention is to provide a patent foramen ovale occluder, which can avoid abrasion of blood vessels while ensuring the anchoring effect, while retaining the possibility of future atrial septal puncture.

[0010] To achieve the above-mentioned purpose, the present invention provides a patent foramen ovale occluder, comprising a left disc, a right disc, a waist connected between the left disc and the right disc, a left anchoring flap portion with multiple flaps connected to the left disc, and a right anchoring flap portion with multiple flaps connected to the right disc; the outer end of the left anchoring flap portion extends outward from the left disc, and a first empty area that runs through the left and right is provided in the left anchoring flap portion and between two adjacent left anchoring flap portions; the outer end of the right anchoring flap portion extends outward from the right disc, and a second empty area that runs through the left and right is provided in the right anchoring flap portion and between two adjacent right anchoring flap portions.

[0011] Furthermore, the left disc and the right disc are both woven from elastic metal wires, and the left anchoring petal portion and the right anchoring petal portion are both bent from elastic metal wires.

[0012] Furthermore, the elastic metal wire is a nickel-titanium alloy wire.

[0013] Furthermore, the patent foramen ovale occluder also includes a proximal rivet head sleeve, the waist is a restraining sleeve, the distal surface of the left disc is a flat surface, and the proximal end is restrained and fixed by the waist, and the distal end of the right disc is restrained and fixed by the waist, and the proximal end is restrained and fixed by the proximal rivet head sleeve.

[0014] Furthermore, the root of the left anchoring flap is constrained and fixed in the waist in the proximal direction, and the root of the right anchoring flap is constrained and fixed in the proximal rivet head cover in the proximal direction; when the patent foramen ovale occluder is received into the delivery device, the left anchoring flap and the right anchoring flap are both closed into a linear shape.

[0015] Furthermore, the diameter of the elastic metal wire used in the left disc and the right disc is 0.1 mm, and the diameter of the elastic metal wire used in the left anchoring petal and the right anchoring petal is 0.2 mm.

[0016] Furthermore, the left anchoring petal portion and the right anchoring petal portion are both petal-shaped.

[0017] Furthermore, the disk diameters R of the left disk and the right disk are both 12-20 mm, the longest distance L1 between the left anchoring petal and the center of the left disk is 9-15 mm, and the longest distance L2 between the right anchoring petal and the center of the right disk is 9-15 mm.

[0018] Furthermore, the left anchoring petal portion and the right anchoring petal portion each have four petals.

[0019] Furthermore, the patent foramen ovale occluder also includes a blood flow blocking membrane for blocking blood flow, and the blood flow blocking membrane is flatly fixed in the left disc and the right disc.

[0020] As described above, the patent foramen ovale occluder according to the present invention has the following beneficial effects:

[0021] In the present application, the left anchoring flap and the right anchoring flap enable the patent foramen ovale occluder to reduce the disc area of ​​the left and right discs by more than 80% while ensuring the anchoring effect, thereby avoiding the left and right discs from abrading the blood vessels, and because the disc surface is reduced, the volume of the occluder after stretching during the delivery process is reduced, and the adapted delivery system is smaller in specification, thereby avoiding the potential damage of the occluder delivery system to the human blood vessels; during the implantation of the patent foramen ovale occluder, the orientation of the left anchoring flap and the right anchoring flap can be adjusted by rotating the patent foramen ovale occluder, thereby avoiding the outer edge of the patent foramen ovale occluder (i.e., the left anchoring flap and the right anchoring flap) from abrading the blood vessels, thereby avoiding the blood vessels from being abraded while ensuring the anchoring effect of the patent foramen ovale occluder, thereby avoiding the blood vessels from being abraded, and ensuring the blocking effect. In particular, the disc area of ​​the left and right discs is reduced by more than 80%, and combined with the first empty area and the second empty area of ​​the patent foramen ovale occluder, it reserves puncture space for future atrial septal puncture, which is beneficial to future surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 Schematic diagram of using a traditional double-disc foramen ovale occluder to occlude the foramen ovale.

[0023] Figure 2 This is a schematic diagram of the structure of the patent foramen ovale occluder in this application.

[0024] Figure 3 for Figure 2 main view.

[0025] Figure 4 for Figure 3 A-direction view.

[0026] Figure 5 for Figure 3 B view.

[0027] Figure 6 This is a schematic diagram of the state in which the patent foramen ovale occluder in this application is completely inserted into the sheath.

[0028] Figure 7 and Figure 8 This is a schematic diagram of the state in which the patent foramen ovale occluder is partially released from the sheath in the present application.

[0029] Fig. 9 This is a schematic diagram of using the patent foramen ovale occluder in the present application to occlude the foramen ovale.

[0030] Component number description

[0031] 1 Left disk

[0032] 2 Right Plate

[0033] 3 Waist

[0034] 4 left anchoring flap

[0035] 5 Right anchor flap

[0036] 6 First empty area

[0037] 7 Second empty area

[0038] 8 Proximal rivet head cover

[0039] 9 Sheath

[0040] 10 Push rod DETAILED DESCRIPTION

[0041] The following is a description of the implementation of the present invention by means of specific embodiments. Those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification.

[0042] It should be noted that the structures, proportions, sizes, etc. drawn in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the limiting conditions for the implementation of the present invention, so they have no substantial technical significance. Any modification of the structure, change of the proportional relationship or adjustment of the size, without affecting the effects and purposes that can be achieved by the present invention, should still fall within the scope of the technical content disclosed by the present invention. At the same time, the terms such as "upper", "lower", "left", "right", "middle" and "one" quoted in this specification are only for the convenience of description, and are not used to limit the scope of the implementation of the present invention. The change or adjustment of their relative relationship should also be regarded as the scope of the implementation of the present invention without substantially changing the technical content.

[0043] like Figures 2 to 5 As shown, the present application provides a patent foramen ovale occluder, comprising a left disc 1, a right disc 2, a waist 3 connected between the left disc 1 and the right disc 2, a left anchoring flap 4 with multiple flaps connected to the left disc 1, and a right anchoring flap 5 with multiple flaps connected to the right disc 2, the left disc 1 and the right disc 2 are respectively distributed at the distal end and the proximal end of the patent foramen ovale occluder, the distal end refers to the end of the patent foramen ovale occluder away from the surgical operator, and the proximal end refers to the end of the patent foramen ovale occluder close to the surgical operator, or, Figure 3 In the view shown, the left side of the paper is the proximal end of the patent foramen ovale occluder, and the right side of the paper is the distal end of the patent foramen ovale occluder. Figure 3 and Figure 4 As shown, the outer end of the left anchoring petal 4 extends outward from the left disc 1, so at least a part of the left anchoring petal 4 is located on the outer peripheral side of the left disc 1, and the left anchoring petal 4 and the left anchoring petals 4 between two adjacent petals have a first empty area 6 that runs through from left to right. Figure 3 and Figure 5As shown, the outer end of the right anchoring petal 5 extends outward from the right disk 2, so at least a part of the right anchoring petal 5 is located on the outer peripheral side of the right disk 2, and a second empty area 7 that runs through the right anchoring petal 5 and between two adjacent right anchoring petals 5 is provided.

[0044] After the patent foramen ovale occluder is implanted into the human body via the delivery device, the patent foramen ovale is anchored at the patent foramen ovale through the left disc 1, the right disc 2, the waist 3, the left anchoring flap 4 and the right anchoring flap 5, and the foramen ovale is blocked. Fig. 9 As shown. The left anchoring flap 4 and the right anchoring flap 5 increase the contact area between the patent foramen ovale occluder and the atrial septum, and the disk area of ​​the left disk 1 and the right disk 2 is minimized under the premise that the patent foramen ovale occluder is reliably anchored at the patent foramen ovale. The present application can reduce the disk area of ​​the left disk 1 and the right disk 2 by more than 80%, and avoid the left disk 1 and the right disk 2 from abrading the blood vessels; and in the process of anchoring the patent foramen ovale occluder after implantation into the human body, the patent foramen ovale occluder can be rotated by the push rod 10, and then the orientation of the left anchoring flap 4 and the right anchoring flap 5 is adjusted, so that the first empty area 6 between the two adjacent left anchoring flaps 4 and the second empty area 7 between the two adjacent right anchoring flaps 5 are directed toward the blood vessels, that is, the outer edge of the patent foramen ovale occluder (i.e., the left anchoring flap 4 and the right anchoring flap 5) is prevented from abrading the blood vessels, so that the anchoring effect of the patent foramen ovale occluder can be ensured, and the blood vessels can be avoided to avoid abrasion of the blood vessels, and the blocking effect can be ensured. The reduction in the disc 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 delivery device and reducing the potential damage of the delivery device to human blood vessels, especially the damage to blood vessels of young patients such as infants. In particular, the disc area of ​​the left disc 1 and the right disc 2 is reduced by more than 80%. Combined with the first empty area 6 in the left anchoring flap 4, the first empty area 6 between the two adjacent left anchoring flaps 4, the second empty area 7 in the right anchoring flap 5, and the second empty area 7 between the two adjacent right anchoring flaps 5, it reserves puncture space for future atrial septal puncture, which is beneficial to future surgery. Therefore, the patent foramen ovale occluder involved in the present application can not only ensure the anchoring and occlusion effect, but also avoid abrasion of blood vessels, and can also retain the possibility of atrial septal puncture after occluding the foramen ovale, thereby helping to improve the effectiveness and safety of interventional treatment of patent foramen ovale in the heart, and can take into account the needs of future atrial puncture.

[0045] Preferably, in this application, if Figure 4 and Figure 5 As shown, the disk diameter R of the left disk 1 and the right disk 2 are both 12-20 mm, the longest distance L1 from the left anchoring petal 4 to the center of the left disk 1 is 9-15 mm, the longest distance L2 from the right anchoring petal 5 to the center of the right disk 2 is also 9-15 mm, the widest width W1 of the left anchoring petal 4 is 6-12 mm, and the widest width W2 of the right anchoring petal 5 is also 6-12 mm.

[0046] like Figures 2 to 5 As shown, 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 flat round mesh disc structures, and the left anchoring flap 4 and the right anchoring flap 5 are both bent from elastic metal wires. Therefore, the left disc 1, the right disc 2, the left anchoring flap 4 and the right anchoring flap 5 all have a self-expansion function, so that the patent foramen ovale occluder can be completely received into the conveying device, and the patent foramen ovale occluder can be restored to its original shape after being released from the conveying device. Preferably, the elastic metal wires used to weave the left disc 1 and the right disc 2, and the elastic metal wires used to form the left anchoring flap 4 and the right anchoring flap 5 are all nickel-titanium alloy wires; nickel-titanium alloy wires are a type of shape memory alloy, which is a special alloy that can automatically restore its own plastic deformation to its original shape at a certain temperature; its expansion rate is above 20%, its fatigue life is extremely long, its damping characteristics are 10 times higher than those of ordinary springs, and its corrosion resistance is better than the best medical stainless steel currently available, so it can meet the application requirements of various types of engineering and medicine, and is a very excellent functional material. In addition, the wire diameter of the elastic metal wires (i.e., nickel-titanium alloy wires) used in the left disc 1 and the right disc 2 is 0.1 mm, and the wire diameter of the elastic metal wires (i.e., nickel-titanium alloy wires) used in the left anchoring flap 4 and the right anchoring flap 5 is 0.2 mm.

[0047] like Figure 3 and Figure 4 As shown, four left anchoring petals 4 are evenly distributed on the outer periphery of the left disc 1, each of which is closely attached to the proximal end surface of the left disc 1 and extends radially outwardly from the left disc 1, and the angle between the center lines of two adjacent left anchoring petals 4 is 90°; each left anchoring petal 4 is petal-shaped, and the left anchoring petal 4 makes the left disc 1 have a petal-shaped edge, so that Figure 4 The patent foramen ovale occluder shown has a flower-like structure; the roots of the two adjacent left anchoring flaps 4 may be partially crossed. Figure 3 and Figure 5 As shown, four right anchoring petals 5 are evenly distributed on the outer periphery of the right disc 2, each right anchoring petal 5 is closely attached to the proximal end surface of the right disc 2 and extends radially outwardly of the right disc 2, and the angle between the center lines of two adjacent right anchoring petals 5 is 90°; each right anchoring petal 5 is petal-shaped, and the right anchoring petal 5 makes the right disc 2 have a petal-shaped edge, so that Figure 5 The patent foramen ovale occluder shown has a flower-like structure; the roots of the two adjacent right anchoring petals 5 may be partially crossed. In addition, in the present application, the left disc 1 and the right disc 2 are parallel, and the left anchoring petal 4 and the right anchoring petal 5 are symmetrically distributed, that is, the left anchoring petal 4 and the right anchoring petal 5 have the same structural size and arrangement position.

[0048] Furthermore, the patent foramen ovale occluder also includes a blood flow barrier membrane, which is flatly sutured and fixed in the left disc 1 and the right disc 2 to block horizontal blood flow. Preferably, the blood flow barrier membrane is a polyester fiber non-woven fabric, which has good wrinkle resistance and shape retention, as well as high strength and elastic recovery ability, ensuring the effect of blocking blood flow, thereby ensuring the blocking effect of the patent foramen ovale occluder. The blood flow barrier membrane set in the left disc 1 and the right disc 2 can be a single layer or multiple layers.

[0049] like Figure 2 and Figure 3 As shown, the patent foramen ovale occluder also includes a proximal rivet head cover 8, the waist 3 is a restraining cover made of metal, the distal surface of the left disc 1 is a flat surface, and the proximal end is restrained and fixed by the waist 3, and 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 head cover 8. Therefore, the patent foramen ovale occluder in the present application is a structure with a single rivet at the proximal end and no rivet at the distal end, or in other words, the left disc 1 adopts a rivet-free design, and the distal end of the left disc 1 has no rivet point, which is conducive to endothelial cell attachment and reduces endothelialization time, while avoiding blood attachment and reducing the possibility of thrombosis.

[0050] Furthermore, if Figure 3 As shown, when the patent foramen ovale occluder is woven, the elastic metal wire constituting the left anchoring petal 4 is constrained and fixed in the waist 3 together with the elastic metal wire woven with the left disc 1, that is, the root of the left anchoring petal 4 is constrained and fixed in the waist 3 in the proximal direction; the elastic metal wire constituting the right anchoring petal 5 is constrained and fixed in the proximal rivet head cover 8 together with the elastic metal wire woven with the right disc 2, that is, the root of the right anchoring petal 5 is constrained and fixed in the proximal rivet head cover 8 in the proximal direction. Therefore, when the patent foramen ovale occluder is received into the delivery device, as shown in FIG. Figure 6 As shown in FIG. 1 , the left anchoring flap 4 and the right anchoring flap 5 are both folded into a linear shape after being stretched, and are received into the delivery device in a linear shape; when the patent foramen ovale occluder is released from the delivery device at the lesion position, as shown in FIG. Figure 8 As shown, the left anchoring flap 4 and the right anchoring flap 5 will return to their original shapes and take on a petal shape, so that the patent foramen ovale occluder takes on a blooming shape when viewed from the proximal side or the distal side.

[0051] Preferably, the restraining sleeve and the proximal rivet head sleeve 8 constituting the waist 3 both include an inner steel sleeve and an outer steel sleeve that are fixedly connected. The ends of the multiple elastic metal wires of the braided left disc 1 and the roots of the elastic metal wires constituting the left anchoring petal 4 can be fixed between the inner steel sleeve and the outer steel sleeve of the waist 3, or they can be tightly fixed in the inner steel sleeve of the waist 3; similarly, the distal ends of the multiple elastic metal wires of the braided right disc 2 can be fixed between the inner steel sleeve and the outer steel sleeve of the waist 3, or they can be tightly fixed in the inner steel sleeve of the waist 3; the proximal ends of the multiple elastic metal wires of the braided right disc 2 and the roots of the elastic metal wires constituting the right anchoring petal 5 can be fixed between the inner steel sleeve and the outer steel sleeve of the proximal rivet head sleeve 8, or they can be tightly fixed in the inner steel sleeve of the proximal rivet head sleeve 8.

[0052] Furthermore, a connecting thread is provided on the proximal inner wall of the outer steel sleeve of the proximal rivet head sleeve 8, which is used to connect with the push rod 10 in the delivery device to achieve a detachable connection between the delivery device and the patent foramen ovale occluder. Figure 3 As shown, the outer wall of the outer steel sleeve of the proximal rivet head sleeve 8 is in a frustum shape, that is, the outer diameter of the outer steel sleeve of the proximal rivet head sleeve 8 gradually decreases from the distal end to the proximal end.

[0053] Preferably, if Figures 6 to 8 As shown, the delivery device for delivering the patent foramen ovale occluder in the present application includes a sheath tube 9 and a push rod 10. The push rod 10 is movably and rotatably arranged in the sheath tube 9. The push rod 10 can be a thin rod or a steel cable.

[0054] The operation of pulling the patent foramen ovale occluder of the above structure into the sheath tube 9 of the delivery device is as follows: Figure 6 As shown, the distal end of the push rod 10 is connected to the proximal end of the proximal rivet head cover 8 of the patent foramen ovale occluder, and the push rod 10 is pulled to move the push rod 10 toward the direction close to the surgical operator, and the push rod 10 drives the patent foramen ovale occluder to move synchronously toward the direction close to the surgical operator until the patent foramen ovale occluder is completely pulled into the sheath tube 9. In the process of the patent foramen ovale occluder being gradually pulled into the sheath tube 9, the proximal end of the right disc 2 first enters the sheath tube 9, and then the right anchoring flap 5 and the right disc 2 begin to deform from the proximal end to the distal end, and are gradually stretched into a straight line before entering the sheath tube 9; then, the waist 3 is pulled into the sheath tube 9; finally, the left anchoring flap 4 and the left disc 1 begin to deform from the proximal end to the distal end, and are gradually stretched into a straight line before entering the sheath tube 9. Therefore, the patent foramen ovale occluder is accommodated in the sheath tube 9 of the delivery device as a whole in a straight line.

[0055] The specific operation of implanting the patent foramen ovale occluder into the patient's body using the delivery device is as follows: Figure 7 and Figure 8As shown, when the push rod 10 is connected to the proximal end of the patent foramen ovale occluder, the push rod 10 is pushed to move away from the surgical operator, and the push rod 10 drives the patent foramen ovale occluder to move synchronously away from the surgical operator until the patent foramen ovale occluder is completely released from the sheath 9. In the process of releasing the patent foramen ovale occluder from the sheath 9, the outer end of the left anchoring flap 4 is first released from the sheath 9, followed by the distal end of the left disc 1. Under the action of the elastic metal wire's own resilience, the left disc 1 and the left anchoring flap 4 are restored from a straight line to their original shapes, which are also the preset extended shapes when not received in the sheath 9; then, the waist 3 is released from the sheath 9; finally, the right disc 2 and the right anchoring flap 5 are released from the sheath 9 and restored to their original shapes, so that the patent foramen ovale occluder is completely released from the sheath 9 and restored to the preset extended shape as a whole; at this time, as shown in FIG. Fig. 9 As shown, the patent foramen ovale occluder is fixed at the patent foramen ovale to achieve implantation and occlusion.

[0056] In summary, the present invention effectively overcomes various shortcomings of the prior art and has high industrial utilization value.

[0057] The above embodiments are merely illustrative of the principles and effects of the present invention, and are not intended to limit the present invention. Anyone familiar with the art may modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by a person of ordinary skill in the art without departing from the spirit and technical concept disclosed by the present invention shall still be covered by the claims of the present invention.

Claims

1. A patent foramen ovale occluder, comprising a left disc (1), a right disc (2), and a waist (3) connected between the left disc (1) and the right disc (2), characterized in that: It also comprises a left anchoring petal portion (4) connected to the left disc (1) with multiple petals, and a right anchoring petal portion (5) connected to the right disc (2) with multiple petals; the outer end of the left anchoring petal portion (4) protrudes outward from the left disc (1), and a first empty area (6) extending from left to right is provided in the left anchoring petal portion (4) and between two adjacent left anchoring petals (4); the outer end of the right anchoring petal portion (5) protrudes outward from the right disc (2), and a second empty area (7) extending from left to right is provided in the right anchoring petal portion (5) and between two adjacent right anchoring petals (5); The left disk (1) and the right disk (2) are both woven from elastic metal wires, the left anchoring petal portion (4) and the right anchoring petal portion (5) are both bent from elastic metal wires, the left anchoring petal portion (4) and the right anchoring petal portion (5) are added to reduce the disk area of ​​the left disk (1) and the right disk (2) by more than 80%, the disk surface diameter R of the left disk (1) and the right disk (2) are both 12-20 mm, the longest distance L1 of the left anchoring petal portion (4) from the center of the left disk (1) is 9-15 mm, and the longest distance L2 of the right anchoring petal portion (5) from the center of the right disk (2) is 9-15 mm; After the patent foramen ovale occluder is implanted, it is anchored by the left disc (1), the right disc (2), the waist (3), the left anchoring flap (4) and the right anchoring flap (5), and the first empty area (6) and the second empty area (7) are used to face the blood vessels and reserve puncture space for future atrial septal puncture.

2. The patent foramen ovale occluder according to claim 1, characterized in that: The elastic metal wire is a nickel-titanium alloy wire.

3. The patent foramen ovale occluder according to claim 1, characterized in that: It also includes a proximal rivet head sleeve (8), the waist (3) is a restraining sleeve, the distal end surface of the left disc (1) is a flat surface, and 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 head sleeve (8).

4. The patent foramen ovale occluder according to claim 3, characterized in that: The root of the left anchoring flap (4) is constrained and fixed in the waist (3) in the proximal direction, and the root of the right anchoring flap (5) is constrained and fixed in the proximal rivet head sleeve (8) in the proximal direction; when the patent foramen ovale occluder is received into the delivery device, the left anchoring flap (4) and the right anchoring flap (5) are both closed into a linear shape.

5. The patent foramen ovale occluder according to claim 1, characterized in that: The diameter of the elastic metal wire used in the left disk (1) and the right disk (2) is 0.1 mm, and the diameter of the elastic metal wire used in the left anchoring petal (4) and the right anchoring petal (5) is 0.2 mm.

6. The patent foramen ovale occluder according to claim 1, characterized in that: The left anchoring petal portion (4) and the right anchoring petal portion (5) are both in the shape of petals.

7. The patent foramen ovale occluder according to claim 1, characterized in that: The left anchoring petal portion (4) and the right anchoring petal portion (5) both have four petals.

8. The patent foramen ovale occluder according to claim 1, characterized in that: It also includes a blood flow barrier membrane for blocking blood flow, and the blood flow barrier membrane is flatly fixed in the left tray (1) and the right tray (2).

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