Oval foramen closer

Abstract

The invention provides an oval foramen closer, which belongs to the technical field of medical instruments and consists of a memory woven umbrella tray, a suture line and a puncture needle. The device further comprises an oval foramen closer conveying sheathing canal, an oval foramen closer loading sheathing canal, an oval foramen closer and a knotter. An oval foramen closer loading sheath tube is connected in the oval foramen closer conveying sheath tube in a sliding and penetrating manner; an oval foramen closer is loaded and slidably connected in the oval foramen closer loading sheath tube in a penetrating manner; the foramen ovale closer at least comprises a foramen ovale imbedding sheathing canal, an umbrella tray propeller and a memory woven umbrella tray. According to the invention, the operation of single-disc single-strand single-thread suture is preferably adopted, so that the foramen ovale can be completely closed. One-time operation is achieved, safety and reliability are achieved, the success rate of the operation can be increased, the medical quality level can be improved, and operation sequelae can be completely eradicated.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an oval foramen closure device. Background Technology

[0002] Generally, the foramen ovale is an open area in the middle of the atrial septum, located at the junction of the primary and secondary septa during embryonic development. The foramen ovale is usually covered by a thin membrane-like structure from the primary septum to the secondary septum. Before birth, the foramen ovale remains open due to right-to-left blood flow. After birth, as normal pulmonary circulation is established, the increased pressure in the left atrium forces the thin membrane-like structure from the primary atrial septum to adhere tightly to the secondary septum and adhere together, thus closing the foramen ovale. The foramen ovale usually closes within the first year of life. If the foramen ovale remains open in children older than 3 years, it is called patent foramen ovale (PFO). 20%–25% of adults have incompletely closed foramen ovale. PFO is the most common congenital heart defect in adults. It has been shown to be associated with various diseases, including cryptogenic stroke and migraine. Therefore, treating PFO is of great importance in preventing these diseases.

[0003] Current treatments for patent foramen ovale (PFO) mainly include open surgery with suturing, interventional closure with a double-disc occluder, and interventional closure with a stapler. Open surgery is too invasive for patients and has been largely phased out. Interventional closure with a stapler is just beginning clinical trials, and its effectiveness remains to be seen. Currently, interventional closure with a double-disc occluder is the mainstream procedure.

[0004] The double-disc occluder consists of two discs, a short waist between them, and a flow-blocking membrane in the center of the discs. The simplified procedure for occluding the foramen ovale using this occluder is as follows: The femoral or jugular vein is punctured, and the occluder is inserted through a delivery sheath into the foramen ovale. The first disc is placed on the left atrial side of the foramen ovale, and the second disc on the right atrial side. The short waist of the occluder is positioned within the foramen ovale, thus completing the occlusion treatment. Normally, endothelial tissue will cover the entire occluder within three to six months.

[0005] The foramen ovale is an overlapping structure (overlapping of the primary and secondary septa) with a certain width of slit (like a curtain), the overlap being approximately 10mm in length. However, in the aforementioned double-umbrella disc occluder, because the two discs are symmetrical, they are connected by a waist only 2-3mm long. This inevitably creates an overlapping septum, leading to curling and deformation due to traction, and preventing the occluder from reshaping. This is why even a foramen ovale of only 1-5mm can result in a larger residual shunt after occlusion. Statistics show that the incidence of residual shunts in interventional occluder procedures is as high as 20%. Residual shunts, along with the inability to reshape and properly adhere to the wall of the disc, continuously lead to thrombus formation. In cases intended to treat migraines, strokes, or other conditions, the patient's condition may worsen after surgery. Summary of the Invention

[0006] The technical objective of this invention is to overcome the shortcomings of the prior art and provide an oval foramen closure device.

[0007] The technical solution of the present invention is implemented in the following manner: the ovoid foramen closure device of the present invention comprises: Memory-woven umbrella discs used to cover and plug the overlapping parts of the primary and secondary septa of the patent foramen ovale; And at least one stitching thread that is fixedly connected to the memory woven umbrella disc; And the puncture needle used to puncture the secondary septum in conjunction with the suture; composition.

[0008] Its structure also includes: Foramen ovale closure device delivery sheath, foramen ovale closure device loading sheath, foramen ovale closure device, knotter; An ovoid aperture closure device loading sheath is slidably inserted inside the delivery sheath of the ovoid aperture closure device; The foramen ovale closure device is loaded inside the sheath and slides through it; An oval foramen closure device includes at least an oval foramen insertion sheath, a parasol advancer, and a memory braided parasol. The oval aperture inserts at least one memory woven umbrella disc insertion channel in the stretched and retracted state into the sheath body. An umbrella disc pusher is provided in the memory woven umbrella disc insertion channel in the stretched and retracted state. A memory woven umbrella disc that can be released and detached is provided at the top of the umbrella disc pusher. The end of the memory woven umbrella disc is equipped with an umbrella hoop that engages with / disengages from the umbrella disc pusher; The umbrella hoop body has a wire hole for threading the umbrella hoop; The oval foramen inserts into the sheath body and has at least one lead wire insertion channel. The lead wire insertion channel passes through the oval foramen inserts into the sheath body and opens from the top of the oval foramen inserts into the sheath body. The foramen ovale is inserted into the sheath body and has a puncture needle sliding cavity. A puncture needle is placed in the puncture needle sliding cavity. The main body of the puncture needle is a straight, rigid and tough body, and its top end is provided with a bend. The bend is bent back 180 degrees and extends into an extension section. At the end of the bend extension section, there is a slanted needle tip that is connected to / disconnects from the needle tip. The needle tip is provided with a lead wire buckle. An oblique needle channel is provided on one side wall of the top section of the oval orifice insertion sheath body; the oblique needle channel extends through the oval orifice insertion sheath body and opens on the surface of the side wall of the oval orifice insertion sheath. The needle tip is angled toward the outward extension direction of the angled needle guide channel, and the needle body is inserted into the angled needle guide channel; The top section of the oval orifice inserted into the sheath body has at least one lead wire outlet channel, which extends downward from the top opening of the oval orifice inserted into the sheath body and passes through the oblique needle channel. The suture insertion channel, umbrella hoop suture hole, suture exit channel, and oblique needle channel sequentially constitute the suture introduction channel; The suture is introduced through the suture inlet channel, passes through the umbrella hoop suture hole, passes through the suture outlet channel, passes through the suture connector of the needle, or is connected to the suture connector of the needle. A curved arm is separated from the side wall of the oval orifice insertion sheath body below the oblique needle channel; the root of the curved arm is hinged to the side wall of the oval orifice insertion sheath; the opening direction of the curved arm is towards the top of the oval orifice insertion sheath. The oval orifice insertion sheath body is provided with at least a hinged arm opening and closing mechanism; A suture guide channel is provided inside the body of the curved arm; the upper opening of the suture guide channel is provided on the inner surface of the curved arm, and a self-locking anti-disengagement buckle for inserting the needle is provided in the upper opening. When the hinge arm is opened to its maximum state, the self-locking anti-disengagement buckle of the needle tip in the upper opening faces the same direction as the oblique needle guide channel, and the two are collinear. When the hinge arm is opened to its maximum state via the hinge opening, the opening portion forms a secondary bite-proof entry point. The suture insertion channel extends along the upturned arm towards its root and passes through the root of the upturned arm; A suture return channel extending to the lower end of the insertion sheath is provided in the oval orifice below the root of the incision arm. The top of the suture thread is fixedly connected to the self-locking anti-dislodgement buckle into which the needle tip is embedded; The suture leads out through the suture introduction channel and the suture return channel, extending towards the lower end of the sheath body inserted into the oval foramen.

[0009] The top of the umbrella hoop and the umbrella disc pusher are screwed together by a threaded fit. The umbrella disc pusher is used to push the memory woven umbrella disc in the folded state. The memory woven umbrella disc can also be equipped with threads. The threads are placed inside the oval hole insertion sheath or the oval hole closure loading sheath. The threads are single-stranded double-stranded reciprocating threads used to pull and adjust the release or retraction of the memory woven umbrella disc.

[0010] Both the introduction suture and the exit suture are set to be single-stranded or double-stranded.

[0011] As the needle descends, it engages with the self-locking anti-disengagement buckle embedded in the supply needle, and the two engage in a self-locking engagement.

[0012] The woven mesh of the memory woven umbrella disc is made of non-degradable nickel-titanium alloy wire, or degradable metal wire, or degradable polymer composite filament material, and has the function of restoring the umbrella shape memory.

[0013] The memory woven umbrella disc uses a memory woven umbrella disc with a unique umbrella hoop. The umbrella hoop is located at the center of the lower surface of the unfolded umbrella disc. The umbrella hoop is used to restrain and fix the ends of the woven body of the memory woven umbrella disc at one point. or, The memory woven umbrella disc uses a memory woven umbrella disc with two umbrella hoops, one of which is located at the center of the upper surface of the unfolded umbrella disc, and the other is located at the center of the lower surface of the unfolded umbrella disc. The material of its umbrella hoop may be biodegradable or non-biodegradable.

[0014] The foramen ovale closure device delivery sheath is configured in the transfemoral cardiac access system for systemic procedures.

[0015] The application of the foramen ovale closure device in the foramen ovale sealing system.

[0016] The application of the foramen ovale closure device in the transfemoral vein cardiac access system.

[0017] The beneficial effects of this invention compared to the prior art are: Current technology necessitates the use of a large fimbriae to completely seal the main foramen ovale. If the fimbriae are not large enough to cover the foramen ovale in the left atrium, blood flow will still occur.

[0018] Generally, a larger umbrella disc is selected. However, if the umbrella disc is larger in size and has a larger diameter, the endothelial layer will have difficulty climbing over the oval pores during self-healing, and thus cannot form a complete epithelial growth that covers the umbrella disc. In other words, endothelialization is poor.

[0019] Besides being too large, the umbrella disc also has a high central bulge, creating a steep slope that prevents the inner skin from climbing up, resulting in poor endothelialization.

[0020] Sometimes, in the early or later stages, it is necessary to locate the fossa ovalis for a puncture of the atrial septum. Therefore, it is not advisable to implant a large and tall fimbriae in the secondary septum of the right atrium.

[0021] Patent foramen ovale (PFO) is a common type of congenital heart disease. It mainly forms during fetal growth and development. During embryonic development, a falx-shaped septum grows on the right side of the first septum, called the second septum or secondary septum. This septum also grows towards the endocardial cushion, covering the second atrial foramen, but does not fuse with the endocardial cushion, forming an oval-shaped opening called the foramen ovale.

[0022] Most existing suture devices involve suturing one stitch on the primary septum and then another on the secondary septum, tightening both ends, and then tying a knot. The position and state of the knot are difficult to control precisely, often resulting in misalignment of the primary and secondary septa. Since this misalignment exists, it's difficult to prevent the blood flow pathway from remaining within the foramen ovale and interatrial canal. This not only causes blood flow problems but also increases the risk of thrombus formation in both atria, especially near the foramen ovale in the left atrium, posing a potential risk to the body's blood circulation.

[0023] If a large device is placed beneath the foramen ovale (FOB) on top of the occluder disc, an overlap will form between the primary and secondary septa, creating a channel for blood flow. The primary and secondary septa fail to naturally adhere and fuse. Even if the procedure successfully seals the FOB site in the left atrium, a blood flow channel formed by the overlap of the primary and secondary septa remains within the FOB between the right and left atria, preventing complete closure of the FOB. This means that even after the procedure, residual shunting may still occur within the FOB channel using existing occluders.

[0024] The foramen ovale closure device of this invention preferably employs a single-disc, single-strand, single-suture technique. It utilizes a unique, single-memory woven umbrella disc, which is inserted from the right atrium through the foramen ovale into the left atrium, opening the umbrella. A single suture is originally placed on the umbrella disc. The puncture needle, carrying the suture, passes directly through the septum from the left atrium to the right atrium via the septum. Only one puncture is required. The suture is then pulled, and during this pulling process, the opened umbrella disc needs to cover the edge of the septum of the foramen ovale, sealing the foramen ovale. The umbrella clamp is positioned at the edge of the septum, without creating wrinkles or misalignment. The suture starting from the umbrella clamp passes directly through the septum, with the suture end inside the right atrium. The procedure involves pulling and knotting the suture with a knotter or inserting a clamp to tighten the suture. Through the action of the underside of the umbrella-shaped plate, the primary septum is smoothly laid over the secondary septum, preventing wrinkles and overlap between the two septa. This completely eliminates the possibility of blood flow pathways caused by overlap, ensuring a smooth suture between the two septa. Under the action of the umbrella-shaped plate, endothelialization of the cardiac wall tissue near the foramen ovale in the left atrium occurs, sealing the umbrella-shaped plate and creating a completely closed foramen ovale. Endothelialization of the cardiac tissue at the knot or clamp in the right atrium also occurs, further sealing the foramen ovale. This achieves complete closure of the foramen ovale. The procedure is performed in a single, safe, and reliable manner, improving the success rate, enhancing the quality of medical care, and preventing postoperative complications.

[0025] The orifice closure device of the present invention is reasonably designed, simple in structure, safe and reliable, easy to use and easy to maintain, and has great value for promotion and use. Attached Figure Description

[0026] Appendix Figure 1 This is a schematic diagram of the structure of the present invention; Appendix Figure 2 This is a schematic diagram of the structure of the present invention; Appendix Figure 3 This is a schematic diagram of the structure of the present invention; Appendix Figure 4 This is a schematic diagram of the structure of the present invention; Appendix Figure 5 This is a schematic diagram of the structure of the present invention; Appendix Figure 6 This is a schematic diagram of the structure of the present invention; Appendix Figure 7 This is a schematic diagram of the structure of the present invention; Appendix Figure 8 This is a schematic diagram of the procedure steps for single-disc, single-strand, double-thread suture of the present invention; Appendix Figure 9 This is a schematic diagram of the procedure steps for single-disc, single-strand, double-thread suture of the present invention; Appendix Figure 10 This is a schematic diagram of the procedure steps for single-disc, single-strand, double-thread suture of the present invention; Appendix Figure 11 This is a schematic diagram of the procedure steps for single-disc, single-strand, double-thread suture of the present invention; Appendix Figure 12 This is a schematic diagram of the procedure steps for single-disc, single-strand, double-thread suture of the present invention; Appendix Figure 13 This is a schematic diagram of the procedure for applying a single-disc, single-strand, double-thread suture with a clip or knot according to the present invention. Appendix Figure 14 This is a schematic diagram of the procedure for applying a single-disc, single-strand, double-thread suture with a clip or knot according to the present invention. Appendix Figure 15 This is a schematic diagram of the procedure steps for single-disc, single-strand, single-thread suture of the present invention; Appendix Figure 16 This is a schematic diagram of the procedure steps for single-disc, single-strand, single-thread suture of the present invention; Appendix Figure 17 This is a schematic diagram of the procedure steps for single-disc, single-strand, single-thread suture according to the present invention; Appendix Figure 18 This is a schematic diagram of the procedure steps for single-disc, single-strand, single-thread suture according to the present invention; Appendix Figure 19 This is a schematic diagram of the procedure steps for single-disc, single-strand, single-thread suture according to the present invention; Appendix Figure 20 This is a schematic diagram of the procedure steps for single-disc, single-strand, single-thread suture according to the present invention; Appendix Figure 21 This is a schematic diagram illustrating the procedure for applying the single-disc, single-strand, single-thread suture with clip of the present invention.

[0027] The markings in the attached diagram represent: 1. The foramen ovale closure device delivers the sheath; 2. The foramen ovale closure device loads the sheath. 3. Insert the sheath through the foramen ovale. 4. Insert the stretched and retracted memory woven umbrella disc into the channel. 5. Umbrella disc pusher; 6. Memory braided umbrella disc; 7. Umbrella hoop; 8. Umbrella hoop threading hole. 9. Thread the lead wire into the channel. 10. Puncture needle sliding cavity, 11. Puncture needle; 12. Straight, rigid body; 13. Bending section; 14. Bending extension section; 15. Needle tip; 16. Wire connector. 17. Slanted needle insertion channel, 18. Lead wire output channel, 19. The suture is introduced into the access channel. 20. Introduce sutures. 21. Curved arm; 22. Suture insertion channel; 23. Upper opening; 24. Self-locking anti-dislodgement buckle for needle insertion. 25. Suture return path. 26. Draw out the suture line. 27. Secondary bite entry, 28. Endothelialization, 29. Knots or clips, 30. Foramen ovale closure device 31. Primary septum; 32. Secondary septum. Detailed Implementation

[0028] The oval orifice closure device of the present invention will be described in detail below with reference to the accompanying drawings.

[0029] As shown in the attached figure, the foramen ovale closure device of the present invention has the following structure: the foramen ovale closure device includes at least a unique memory braided umbrella disc, a unique secondary septal puncture device, and at least one suture.

[0030] Foramen ovale closure device delivery sheath, foramen ovale closure device loading sheath, foramen ovale closure device, knotter; An ovoid aperture closure device loading sheath is slidably inserted inside the delivery sheath of the ovoid aperture closure device; The foramen ovale closure device is loaded inside the sheath and slides through it; An oval foramen closure device includes at least an oval foramen insertion sheath, a parasol advancer, and a memory braided parasol. The oval aperture inserts at least one memory woven umbrella disc insertion channel in the stretched and retracted state into the sheath body. An umbrella disc pusher is provided in the memory woven umbrella disc insertion channel in the stretched and retracted state. A memory woven umbrella disc that can be released and detached is provided at the top of the umbrella disc pusher. The end of the memory woven umbrella disc is equipped with an umbrella hoop that engages with / disengages from the umbrella disc pusher; The umbrella hoop body has a wire hole for threading the umbrella hoop; The oval foramen inserts into the sheath body and has at least one lead wire insertion channel. The lead wire insertion channel passes through the oval foramen inserts into the sheath body and opens from the top of the oval foramen inserts into the sheath body. The foramen ovale is inserted into the sheath body and has a puncture needle sliding cavity. A puncture needle is placed in the puncture needle sliding cavity. The main body of the puncture needle is a straight, rigid and tough body, and its top end is provided with a bend. The bend is bent back 180 degrees and extends into an extension section. At the end of the bend extension section, there is a slanted needle tip that is connected to / disconnects from the needle tip. The needle tip is provided with a lead wire buckle. An oblique needle channel is provided on one side wall of the top section of the oval orifice insertion sheath body; the oblique needle channel extends through the oval orifice insertion sheath body and opens on the surface of the side wall of the oval orifice insertion sheath. The needle tip is angled toward the outward extension direction of the angled needle guide channel, and the needle body is inserted into the angled needle guide channel; The top section of the oval orifice inserted into the sheath body has at least one lead wire outlet channel, which extends downward from the top opening of the oval orifice inserted into the sheath body and penetrates to the oblique needle channel. The suture insertion channel, umbrella hoop suture hole, suture exit channel, and oblique needle channel sequentially constitute the suture introduction channel; The suture is introduced through the suture inlet channel, passes through the umbrella hoop suture hole, passes through the suture outlet channel, passes through the suture connector of the needle, or is connected to the suture connector of the needle. A curved arm is separated from the side wall of the oval orifice insertion sheath body below the oblique needle channel; the root of the curved arm is hinged to the side wall of the oval orifice insertion sheath; the opening direction of the curved arm is towards the top of the oval orifice insertion sheath. The oval orifice insertion sheath body is provided with at least a hinged arm opening and closing mechanism; A suture guide channel is provided inside the body of the curved arm; the upper opening of the suture guide channel is provided on the inner surface of the curved arm, and a self-locking anti-disengagement buckle for inserting the needle is provided in the upper opening. When the hinge arm is opened to its maximum state, the self-locking anti-disengagement buckle of the needle tip in the upper opening faces the same direction as the oblique needle guide channel, and the two are collinear. When the hinge arm is opened to its maximum state via the hinge opening, the opening portion forms a secondary bite-proof entry point. The suture insertion channel extends along the upturned arm towards its root and passes through the root of the upturned arm; A suture return channel extending to the lower end of the insertion sheath is provided in the oval orifice below the root of the incision arm. The top of the suture thread is fixedly connected to the self-locking anti-dislodgement buckle into which the needle tip is embedded; The suture leads out through the suture introduction channel and the suture return channel, extending towards the lower end of the sheath body inserted into the oval foramen.

[0031] The top of the umbrella hoop and the umbrella disc pusher are screwed together by a threaded fit. The umbrella disc pusher is used to push the memory woven umbrella disc in the folded state. The memory woven umbrella disc can also be equipped with threads. The threads are placed inside the oval hole insertion sheath or the oval hole closure loading sheath. The threads are single-stranded double-stranded reciprocating threads used to pull and adjust the release or retraction of the memory woven umbrella disc.

[0032] Both the introduction suture and the exit suture are set to be single-stranded or double-stranded.

[0033] As the needle descends, it engages with the self-locking anti-disengagement buckle embedded in the supply needle, and the two engage in a self-locking engagement.

[0034] The woven mesh of the memory woven umbrella disc is made of non-degradable nickel-titanium alloy wire, or degradable metal wire, or degradable polymer composite filament material, and has the function of restoring the umbrella shape memory.

[0035] The memory woven umbrella disc uses a memory woven umbrella disc with a unique umbrella hoop. The umbrella hoop is located at the center of the lower surface of the unfolded umbrella disc. The umbrella hoop is used to restrain and fix the ends of the woven body of the memory woven umbrella disc at one point. or, The memory woven umbrella disc uses a memory woven umbrella disc with two umbrella hoops, one of which is located at the center of the upper surface of the unfolded umbrella disc, and the other is located at the center of the lower surface of the unfolded umbrella disc. The material of its umbrella hoop may be biodegradable or non-biodegradable.

[0036] The foramen ovale closure device delivery sheath is configured in the transfemoral cardiac access system for systemic procedures.

[0037] The application of the foramen ovale closure device in the foramen ovale sealing system.

[0038] The application of the foramen ovale closure device in the transfemoral vein cardiac access system.

Claims

1. An oval foramen closure device, characterized in that... The foramen ovale closure device is composed of: Memory-woven umbrella discs used to cover and plug the overlapping parts of the primary and secondary septa of the patent foramen ovale; And at least one stitching thread that is fixedly connected to the memory woven umbrella disc; And the puncture needle used to puncture the secondary septum in conjunction with the suture; composition.

2. The oval foramen closure device as described in claim 1, characterized in that... It also includes: Foramen ovale closure device delivery sheath, foramen ovale closure device loading sheath, foramen ovale closure device, knotter; An ovoid aperture closure device loading sheath is slidably inserted inside the delivery sheath of the ovoid aperture closure device; The foramen ovale closure device is loaded inside the sheath and slides through it; An oval foramen closure device includes at least an oval foramen insertion sheath, a parasol advancer, and a memory braided parasol. The oval aperture inserts at least one memory woven umbrella disc insertion channel in the stretched and retracted state into the sheath body. An umbrella disc pusher is provided in the memory woven umbrella disc insertion channel in the stretched and retracted state. A memory woven umbrella disc that can be released and detached is provided at the top of the umbrella disc pusher. The end of the memory woven umbrella disc is equipped with an umbrella hoop that engages with / disengages from the umbrella disc pusher; The umbrella hoop body has a wire hole for threading the umbrella hoop; The oval foramen inserts into the sheath body and has at least one lead wire insertion channel. The lead wire insertion channel passes through the oval foramen inserts into the sheath body and opens from the top of the oval foramen inserts into the sheath body. The foramen ovale is inserted into the sheath body and has a puncture needle sliding cavity. A puncture needle is placed in the puncture needle sliding cavity. The main body of the puncture needle is a straight, rigid and tough body, and its top end is provided with a bend. The bend is bent back 180 degrees and extends into an extension section. At the end of the bend extension section, there is a slanted needle tip that is connected to / disconnects from the needle tip. The needle tip is provided with a lead wire buckle. An oblique needle channel is provided on one side wall of the top section of the oval orifice insertion sheath body; the oblique needle channel extends through the oval orifice insertion sheath body and opens on the surface of the side wall of the oval orifice insertion sheath. The needle tip is angled toward the outward extension direction of the angled needle guide channel, and the needle body is inserted into the angled needle guide channel; The top section of the oval orifice inserted into the sheath body has at least one lead wire outlet channel, which extends downward from the top opening of the oval orifice inserted into the sheath body and penetrates to the oblique needle channel. The suture insertion channel, umbrella hoop suture hole, suture exit channel, and oblique needle channel sequentially constitute the suture introduction channel; The suture is introduced through the suture inlet channel, passes through the umbrella hoop suture hole, passes through the suture outlet channel, passes through the suture connector of the needle, or is connected to the suture connector of the needle. A curved arm is separated from the side wall of the oval orifice insertion sheath body below the oblique needle channel; the root of the curved arm is hinged to the side wall of the oval orifice insertion sheath; the opening direction of the curved arm is towards the top of the oval orifice insertion sheath. The oval orifice insertion sheath body is provided with at least a hinged arm opening and closing mechanism; A suture guide channel is provided inside the body of the curved arm; the upper opening of the suture guide channel is provided on the inner surface of the curved arm, and a self-locking anti-disengagement buckle for inserting the needle is provided in the upper opening. When the hinge arm is opened to its maximum state, the self-locking anti-disengagement buckle of the needle tip in the upper opening faces the same direction as the oblique needle guide channel, and the two are collinear. When the hinge arm is opened to its maximum state via the hinge opening, the opening portion forms a secondary bite-proof entry point. The suture insertion channel extends along the upturned arm towards its root and passes through the root of the upturned arm; A suture return channel extending to the lower end of the insertion sheath is provided in the oval orifice below the root of the incision arm. The top of the suture thread is fixedly connected to the self-locking anti-dislodgement buckle into which the needle tip is embedded; The suture leads out through the suture introduction channel and the suture return channel, extending towards the lower end of the sheath body inserted into the oval foramen.

3. The oval foramen closure device according to claim 1, characterized in that: The top of the umbrella hoop and the umbrella disc pusher are screwed together by a threaded fit. The umbrella disc pusher is used to push the memory woven umbrella disc in the folded state. The memory woven umbrella disc can also be equipped with threads. The threads are placed inside the oval hole insertion sheath or the oval hole closure loading sheath. The threads are single-stranded double-stranded reciprocating threads used to pull and adjust the release or retraction of the memory woven umbrella disc.

4. The oval foramen closure device according to claim 1, characterized in that: Both the introduction suture and the exit suture are set to be single-stranded or double-stranded.

5. The oval foramen closure device according to claim 1, characterized in that: As the needle descends, it engages with the self-locking anti-disengagement buckle embedded in the supply needle, and the two engage in a self-locking engagement.

6. The oval foramen closure device according to claim 1, characterized in that: The woven mesh of the memory woven umbrella disc is made of non-degradable nickel-titanium alloy wire, or degradable metal wire, or degradable polymer composite filament material, and has the function of restoring the umbrella shape memory.

7. The oval foramen closure device according to claim 1, characterized in that: The memory woven umbrella disc uses a memory woven umbrella disc with a unique umbrella hoop. The umbrella hoop is located at the center of the lower surface of the unfolded umbrella disc. The umbrella hoop is used to restrain and fix the ends of the woven body of the memory woven umbrella disc at one point. or, The memory woven umbrella disc uses a memory woven umbrella disc with two umbrella hoops, one of which is located at the center of the upper surface of the unfolded umbrella disc, and the other is located at the center of the lower surface of the unfolded umbrella disc. The material of its umbrella hoop may be biodegradable or non-biodegradable.

8. The oval foramen closure device according to claim 1, characterized in that: The foramen ovale closure device delivery sheath is configured in the transfemoral cardiac access system for systemic procedures.

9. The application of the foramen ovale closure device as described in claims 2 to 8 in a foramen ovale sealing system.

10. The foramen ovale closure device as described in claims 2 to 8, used in a transfemoral cardiac access system.

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