Patent foramen ovale closure device

Abstract

The present invention provides a patent foramen ovale plugging device, comprising: a delivery catheter; an elastic metal mesh with an annular cross section, the elastic metal mesh being able to radially stretch and contract under the action of an external force, so that the elastic metal mesh can be contracted in the delivery catheter, and can be expanded to a state matching the size of the oval foramen after being extended out of the delivery catheter; a connecting component connected to both ends of the elastic metal mesh to support and limit the elastic metal mesh, the connecting component being flexible and able to deform and extend into the delivery catheter, and being able to restore to its original structural state when extending out of the delivery catheter; and a pushing rod being able to extend into the delivery catheter and detachably connected to the connecting component, so as to cooperate with the delivery catheter to push the elastic metal mesh and the connecting component to the oval foramen, and push the elastic metal mesh and the connecting component out of the delivery catheter, so as to cooperate to plug the oval foramen. The patent foramen ovale plugging device of the present invention can plug the oval foramen more conveniently and effectively.

Description

Technical Field

[0001] The embodiments of the present invention relate to the technical field of medical devices, and in particular to a patent foramen ovale occluding device. Background Art

[0002] The foramen ovale is a physiological channel of the atrial septum during the embryonic period of the heart. It is located at the junction of the primary septum and the secondary septum during the embryonic period. It is usually covered by the thin sheet-like structure of the primary septum to form a slit-like abnormal channel, similar to a functional valve. Most people achieve anatomical closure one year after birth. Those who have not closed after the age of 3 are called patent foramen ovale (PFO), and the prevalence rate of the population is 20%-34%.

[0003] Stroke is one of the main causes of disability and death, and acute ischemic stroke accounts for about 80% of all strokes. Although imaging diagnostic technology continues to advance, the cause of ischemic stroke in 15% to 30% of patients is still unclear, that is, unexplained ischemic stroke. It is common in young and middle-aged patients (≤60 years old) with fewer traditional cardiovascular risk factors such as atherosclerosis, and manifests as non-lacunar infarction. Large-scale epidemiological studies in recent years have shown that PFO is a previously underestimated stroke mechanism and is closely related to unexplained stroke. Clinical studies in recent years have shown that percutaneous PFO closure has advantages in preventing stroke recurrence compared with non-specific stroke prevention strategies such as antiplatelet therapy alone.

[0004] Migraine is a common neurological disease characterized by recurrent, mostly unilateral, moderate to severe throbbing headaches, often accompanied by nausea, vomiting, photophobia, and phonophobia. The annual prevalence of migraine is 14.4%, including 18.9% in women and 9.8% in men, making it the second most common disabling neurological disease. The incidence of migraine in the PFO population is 5.13 times that of the normal population, the incidence of PFO in migraine patients is 2.54 times that of the normal population, and the incidence of PFO in patients with unexplained stroke and migraine is as high as 79%. Current clinical studies have shown that closing PFO can terminate or relieve migraine symptoms. Current clinical research results show that compared with drug treatment, percutaneous PFO closure can better improve migraine symptoms in patients with aura symptoms and combined cerebrovascular disease.

[0005] At present, percutaneous PFO closure is an effective treatment method. The disc-shaped occluder is placed at the unclosed foramen ovale through a catheter, guidewire, etc. to achieve the effect of closing the PFO. However, the delivery of the PFO occluder requires a delivery sheath of at least 9F (inner diameter 3mm), which causes great trauma to the femoral vein puncture site. At the same time, heparin should be used for anticoagulation during the operation to prevent thrombosis, which can easily cause bleeding at the puncture site. The current inner diameter of the PFO occluder is 18mm to 24mm. The diameter of the occluder is large, which may affect the mitral and tricuspid valves in some patients, leading to mitral and tricuspid regurgitation. The PFO occluder is permanently retained in the atrial septum and has a large diameter. If the patient needs a transseptal puncture due to other diseases (such as atrial fibrillation, severe mitral regurgitation), the occluder will cause difficulty or failure in transseptal puncture. Summary of the invention

[0006] The embodiment of the present invention provides a patent foramen ovale occluding device that can more conveniently and effectively occlude the foramen ovale.

[0007] In order to solve the above technical problems, an embodiment of the present invention provides a patent foramen ovale occlusion device, comprising:

[0008] delivery catheter;

[0009] An elastic metal mesh, the cross section of which is annular, can be stretched and contracted in the radial direction under the action of an external force, so that the elastic metal mesh can be contracted in the delivery catheter, and can be expanded to a state matching the size of the oval foramen after being extended out of the delivery catheter;

[0010] A connecting component connected to both ends of the elastic metal mesh to support and limit the elastic metal mesh, wherein the connecting component is flexible and can be deformed to extend into the delivery conduit and can be restored to its original structural state when extending out of the delivery conduit; and

[0011] The push rod can be inserted into the delivery catheter and detachably connected to the connecting component to cooperate with the delivery catheter to push the elastic metal mesh and the connecting component to the oval foramen, and push the elastic metal mesh and the connecting component out of the delivery catheter to cooperate in blocking the oval foramen.

[0012] In some embodiments, the connection assembly includes a first connection member and a second connection member, the first connection member and the second connection member are respectively connected to two ends of the elastic metal mesh, and the push rod is detachably connected to the first connection member.

[0013] In some embodiments, the first connecting member includes a first part and a second part, the first part is vertically connected to the second part, and the first part and the second part are interconnected, and the pushing rod is detachably connected to the first part.

[0014] In some embodiments, the first part is tubular, the second part is composed of at least two first slats, the first slats are made of flexible metal, and at least two of the first slats are cross-arranged so that the second part can be bent and abut against the second part, and can be unfolded in a scattered shape, the first part passes through the second part, the elastic metal mesh is sleeved on the first part and connected to the first part, and one end of the push rod passes through the second part and extends into the first part.

[0015] In some embodiments, the first portion is threadably connected to the push rod.

[0016] In some embodiments, the second connecting member includes a third part and a fourth part, the third part is vertically connected to the fourth part, the third part is tubular, and the fourth part is composed of at least two second slats, the second slats are made of flexible metal, and at least two of the second slats are cross-arranged so that the fourth part can be bent and abut against the third part, and can be unfolded into a scattered shape, and the elastic metal mesh is sleeved on the third part and connected to it.

[0017] In some embodiments, at least part of the first part and the third part are nested with each other and can move relative to each other to get closer or farther away. When the connecting component and the elastic metal mesh extend out of the delivery catheter, the elastic metal mesh inflates and extends into the oval foramen. After the first connecting member and the second connecting member are unfolded, they are located on both sides of the oval foramen. The first connecting member and the second connecting member move relative to each other to clamp the opposite sides of the oval foramen and at the same time compress the elastic metal mesh to block the oval foramen.

[0018] In some embodiments, the push rod is a hollow tube, and an auxiliary guide wire is inserted into the push rod. One end of the auxiliary guide wire extends into the third part and is detachably connected to the fourth part. The auxiliary guide wire is used to pull the second connecting member to move it toward the first connecting member, thereby clamping the two sides of the oval foramen ovale and compressing the elastic metal mesh at the same time.

[0019] In some embodiments, stop structures capable of abutting against each other are respectively provided in the third part and on the auxiliary guide wire.

[0020] In some embodiments, the delivery catheter is made of a flexible material, and an inner sheath is inserted into the delivery catheter to support and guide the delivery catheter to move to the foramen ovale, and the inner sheath is a hollow structure.

[0021] Based on the disclosure of the above embodiments, it can be known that the beneficial effects possessed by the embodiments of the present invention include that the overall device structure is flexible and can be folded, so that it is easy to be put into the delivery catheter, and can be delivered into the patient's body based on the delivery catheter. When the pushing device extends out of the delivery catheter, each structure is released in batches, so the overall inner diameter of the delivery catheter is required to be relatively low, and the delivery catheter is supported to be set to a smaller inner diameter, so the trauma to the patient's puncture site is relatively small, reducing the risk of bleeding. In addition, the occluding device of this embodiment also supports small size settings, and the diameter of the elastic metal mesh is variable, and it can match and adjust its own size according to the size of the oval foramen, so it has little effect on the mitral valve and tricuspid valve of the heart, and does not affect the function of the heart valve, especially when the patient needs a transatrial septal puncture due to other diseases, such as atrial fibrillation, severe mitral regurgitation, etc., the occluding device has little effect on the puncture, and the puncture can be carried out smoothly.

[0022] Other features and advantages of the present application will be described in the following description, and partly become apparent from the description, or be understood by practicing the present application. The purpose and other advantages of the present application can be realized and obtained by the structures specifically pointed out in the written description, claims, and drawings.

[0023] The technical solution of the present application is further described in detail below through the accompanying drawings and embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings in the following description are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0025] Figure 1 Schematic diagram of the structure of a patent foramen ovale occlusion device in an embodiment of the present invention.

[0026] Figure 2 It is a partial structural schematic diagram of a patent foramen ovale occlusion device in an embodiment of the present invention.

[0027] Figure 3 Schematic diagram of another part of the structure of the patent foramen ovale occlusion device in an embodiment of the present invention.

[0028] Figure 4 Schematic diagram of another part of the structure of the patent foramen ovale occlusion device in an embodiment of the present invention.

[0029] Reference numerals:

[0030] 1-delivery catheter; 2-elastic metal mesh; 3-first connecting piece; 4-second connecting piece; 5-push rod; 6-first part; 7-first slat; 8-third part; 9-second slat; 10-auxiliary guide wire; 11-stop structure; 12-inner sheath. DETAILED DESCRIPTION

[0031] The specific embodiments of the present invention are described in detail below with reference to the accompanying drawings, but are not intended to limit the present invention.

[0032] It should be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the following description should not be considered as limiting, but merely as an example of an embodiment. Other modifications within the scope and spirit of the present disclosure will occur to those skilled in the art.

[0033] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the present disclosure and, together with the general description of the present disclosure given above and the detailed description of the embodiments given below, serve to explain the principles of the present disclosure.

[0034] These and other characteristics of the invention will become apparent from the following description of a preferred form of embodiment given as a non-limiting example, with reference to the accompanying drawings.

[0035] It should also be understood that, although the invention has been described with reference to some specific examples, those skilled in the art will be able to realize many other equivalent forms of the invention that have the characteristics recited in the claims and are therefore within the scope of protection defined thereby.

[0036] The above and other aspects, features and advantages of the present disclosure will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings.

[0037] Specific embodiments of the present disclosure are described hereinafter with reference to the accompanying drawings; however, it should be understood that the disclosed embodiments are merely examples of the present disclosure, which may be implemented in a variety of ways. Well-known and / or repeated functions and structures are not described in detail to avoid obscuring the present disclosure with unnecessary or redundant details. Therefore, the specific structural and functional details disclosed herein are not intended to be limiting, but merely serve as a basis and representative basis for the claims to teach those skilled in the art to use the present disclosure in a variety of ways with substantially any suitable detailed structure.

[0038] This specification may use the phrases "in one embodiment," "in another embodiment," "in a further embodiment," or "in other embodiments," all of which may refer to one or more of the same or different embodiments according to the present disclosure.

[0039] The embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0040] The foramen ovale is a physiological channel of the atrial septum during the embryonic period of the heart. It is located at the junction of the primary septum and the secondary septum during the embryonic period. It is usually covered by the thin sheet-like structure of the primary septum to form a slit-like abnormal channel, similar to a functional valve. Most people achieve anatomical closure one year after birth. Those who have not closed after the age of 3 are called patent foramen ovale (PFO).

[0041] Currently, percutaneous PFO closure is an effective treatment method, which uses a catheter, guidewire, etc. to place a disc-shaped occluder at the unclosed foramen ovale to achieve the effect of closing the PFO. However, existing PFO closure devices generally have the following problems:

[0042] 1. The delivery of the PFO closure device requires a delivery sheath (delivery tube) of at least 9F (inner diameter 3mm), which causes great trauma to the femoral vein puncture site. Heparin is required for anticoagulation during the operation to prevent thrombosis, which can easily cause bleeding at the puncture site;

[0043] 2. The inner diameter of the current PFO occlusion device is 18mm to 24mm. The diameter of the occluder is relatively large. When used in some patients, it may affect the mitral valve and tricuspid valve of the heart, causing mitral valve and tricuspid valve regurgitation;

[0044] 3. After the PFO occlusion device is assembled, it will remain permanently in the atrial septum. However, due to its large diameter, when the patient needs atrial septal puncture due to other diseases (such as atrial fibrillation, severe mitral regurgitation), the occlusion device will cause difficulty or failure in atrial septal puncture.

[0045] To solve the above problems, Figure 1 and 2 As shown, an embodiment of the present invention provides a patent foramen ovale occlusion device, comprising:

[0046] Delivery catheter 1;

[0047] The elastic metal mesh 2 has a ring-shaped cross section, and the elastic metal mesh 2 can be stretched and contracted in the radial direction under the action of an external force, so that the elastic metal mesh 2 can be contracted in the delivery catheter 1, and can be expanded to a state matching the size of the oval foramen after being extended out of the delivery catheter 1;

[0048] A connecting component connected to both ends of the elastic metal mesh 2 to support and limit the elastic metal mesh 2, wherein the connecting component is flexible and can be deformed to extend into the delivery conduit 1, and can be restored to its original structural state when extending out of the delivery conduit 1; and

[0049] The push rod 5 can be inserted into the delivery catheter 1 and detachably connected to the connecting component to cooperate with the delivery catheter 1 to push the elastic metal mesh 2 and the connecting component to the oval foramen, and push the elastic metal mesh 2 and the connecting component out of the delivery catheter 1 to cooperate in blocking the oval foramen.

[0050] For example, the elastic metal mesh 2 and the connecting assembly in this embodiment cooperate to form an occluder, and the elastic metal mesh 2 and the connecting assembly can be gathered in the delivery catheter 1, and the push rod 5 extends into the delivery catheter 1 and is detachably connected to the connecting assembly. The medical staff can use the push rod 5 to send the occluder into the patient's body along the delivery catheter 1 to the oval foramen of the heart, and then push the occluder out of the delivery catheter 1. The occluder is not bound by the delivery catheter 1 and then swells up, thereby firmly blocking the oval foramen. At this time, the medical staff can extract the push rod 5 and the delivery catheter 1 from the patient's body to complete the oval foramen blocking operation.

[0051] The elastic metal mesh 2 in this embodiment is in a woven state, so it can shrink to various degrees in the axial and radial directions under the action of external force, and its size is variable, and the overall size can be changed according to the actual scene requirements. The connection component is flexible and can be a structural member made of flexible metal, so it has a strong deformation ability, supports folding and shrinking, and can make various degrees of deformation under the action of external force. In addition, the connection component in this embodiment can also automatically expand and return to the initial state when the external force is lost. For example, the connection component can be made of, but not limited to, memory metal.

[0052] Based on the disclosure of the above embodiments, it can be known that the beneficial effects of this embodiment include that the overall device structure is flexible and can be folded, so that it is easy to be put into the delivery catheter 1, so that it can be delivered into the patient's body based on the delivery catheter 1. When the pushing device extends out of the delivery catheter 1, each structure is released in batches, so the overall inner diameter of the delivery catheter 1 is required to be relatively low, and the delivery catheter 1 is supported to be set to a smaller inner diameter, so the trauma to the patient's puncture site is relatively small, reducing the risk of bleeding. In addition, the occluding device of this embodiment also supports small size settings, and the diameter of the elastic metal mesh 2 is variable, and it can match and adjust its own size according to the size of the oval foramen, so it has little effect on the mitral valve and tricuspid valve of the heart, and does not affect the function of the heart valve, especially when the patient needs a transatrial septal puncture due to other diseases, such as atrial fibrillation, severe mitral regurgitation, etc., the occluding device has little effect on the puncture, and the puncture can be carried out smoothly.

[0053] Further, the connection assembly includes a first connection member 3 and a second connection member 4, the first connection member 3 and the second connection member 4 are respectively connected to the two ends of the elastic metal mesh 2, and the push rod 5 is detachably connected to the first connection member 3. That is, the elastic metal mesh 2 is respectively connected to the first connection member 3 and the second connection member 4 at both ends to form an occluder for the oval foramen, wherein the first connection member 3 is located at the end close to the medical staff, and the push rod 5 is preferably connected to the first connection member 3 for easy connection and operation.

[0054] Specifically, Figure 1 and Figure 2 As shown, the first connecting member 3 includes a first part 6 and a second part, and the first part 6 is vertically connected to the second part, that is, the longitudinal sections of the first part 6 and the second part are approximately T-shaped. The first part 6 and the second part are interconnected, such as the first part 6 is the axial part of the T-shape, the second part is the radial part of the T-shape, the first part 6 is hollow and passes through the second part, and the push rod 5 is detachably connected to the first part 6.

[0055] Continue to combine Figure 1 , Figure 2 and Figure 3 As shown, the first part 6 in this embodiment is tubular, and the second part is composed of at least two first slats 7, and at least two first slats 7 are arranged crosswise, that is, forming an X shape. Of course, the number of first slats 7 can also be multiple, such as three, four, etc., and there is no specific limit, as long as the multiple first slats 7 can be smoothly folded and unfolded. The first slats 7 are made of flexible metal, such as memory metal, so that the first slats 7 can be folded and bent under the pressure of the conveying conduit 1, and then abut on the first part 6, and can automatically unfold in a scattered shape when it is moved out of the conveying conduit 1 and is no longer pressed by the conveying conduit 1, that is, automatically restore to the initial state, so that the multiple first slats 7 cooperate to form an umbrella shape. The first part 6 is preferably arranged at the center of the cross-arrangement of multiple first slats 7, and penetrates the central area, so that the first part 6 and the second part are connected to each other. The elastic metal mesh 2 is sleeved on the first part 6 and connected to the first part 6. One end of the push rod 5 passes through the second part and extends into the first part 6, and is detachably connected to the first part 6.

[0056] In an optional embodiment, the first part 6 is provided with an internal thread adjacent to the connection with the second part, and one end of the push rod 5 is provided with an external thread in a matching manner, and the threaded end of the push rod 5 is inserted into the first part 6 and screwed with the internal thread to achieve a detachable connection with the first part 6. Of course, the connection method is not limited thereto, and can also be other methods such as interference fit, snap connection, etc. As long as the push rod 5 can smoothly push the occluder to the oval foramen, and can facilitate medical personnel to separate the push rod 5 from the occluder and pull it out of the patient's body, any connection structure can be applicable and is within the protection scope required by this embodiment.

[0057] Further, combined with Figure 1 and Figure 2 As shown, the second connecting member 4 includes a third part 8 and a fourth part, the third part 8 is vertically connected to the fourth part, the third part 8 is tubular, and the fourth part is composed of at least two second slats 9, at least two second slats 9 are cross-arranged, that is, they also form an X shape. Of course, the number of second slats 9 can also be multiple, such as three, four, etc., and there is no specific limit, as long as the multiple second slats 9 can be smoothly folded and unfolded. The number and shape of the second slats 9 can be the same as or different from the number and shape of the first slats 7. In addition, the structural shapes of the multiple first slats 7 can be the same or different, and the structural shapes of the multiple second slats 9 can be the same or different, and there is no excessive restriction on this. In this embodiment, the second slats 9 are also made of flexible metal, such as memory metal, so that the second slats 9 can also be folded and bent under the pressure of the conveying conduit 1, and then abut against the third part 8, and can automatically unfold into a scattered shape when it is removed from the conveying conduit 1 and no longer under the pressure of the conveying conduit 1, that is, automatically restore to the initial state, so that the multiple second slats 9 cooperate to form an umbrella shape. The third part 8 is preferably arranged at the center of the intersection of multiple first slats 7 and does not pass through the fourth part. For example, the end of the third part 8 connected to the fourth part is a closed end, or the end of the third part 8 connected to the fourth part is an open end, and the fourth part covers the open end by connection, etc. The elastic metal mesh 2 is sleeved on the third part 8 and connected thereto.

[0058] In actual application, the diameter of the tube in the first connecting member 3 is about 1.1 mm, the diameter of the tube in the second connecting member 4 is about 1.3 mm, the diameter of the elastic metal mesh 2 is about 1.5 mm, the length is about 6 mm, the length of the first slat 7 is about 5 mm, the central through hole is about 1.5 mm, and the length of the second slat 9 is about 2 cm. The above dimensions are not fixed and can be flexibly adapted according to actual conditions. Here, they are only used as examples. In addition, the dimensions of the first slat 7 and the second slat 9 can also be set to the same form.

[0059] Continue to combine Figure 2 As shown, in order to enable the occluder to stably and firmly block the oval foramen, in this embodiment, at least part of the first part 6 and the third part 8 are mutually sleeved and can move relative to each other to get closer or farther away. That is, the first connecting member 3 and the second connecting member 4 are arranged in the form of partially opposing tube bodies, and the two tube bodies are of different sizes, so that the tube bodies of the first connecting member 3 and the second connecting member 4 are in a plug-in state, and can move axially relative to their respective tube bodies to adjust the interval between the first strip 7 and the second strip 9 in the first connecting member 3 and the second connecting member 4. The change of the interval directly affects the size of the elastic metal mesh 2 between the two connecting members. When the interval is reduced, the axial size of the elastic metal mesh 2 is reduced and the radial size is increased.

[0060] For example, when the occluder formed by the connection assembly and the elastic metal mesh 2 is pushed out of the delivery catheter 1 by the push rod 5, the second connection member 4 is first released and expanded to its initial scattered state, then the elastic metal mesh 2 is released and expanded to its initial scattered state, and then the first connection member 3 is released and expanded to its initial scattered state. Among them, since the delivery catheter 1 is adjacent to or passes through the oval foramen, as the occluder is pushed out and released, the first connection member 3 and the second connection member 4 are respectively located on opposite sides of the oval foramen, and the elastic metal mesh 2 is located inside the oval foramen. At this time, the interval between the first connecting member 3 and the second connecting member 4 will be greater than the wall thickness of the tissue where the oval foramen is located, so that the elastic metal mesh 2 cannot firmly block the oval foramen. Therefore, at this time, medical personnel can operate and drive the second connecting member 4 and the first connecting member 3 to move relative to each other, so that the two are close to each other and the interval is reduced, and at the same time axially compress the elastic metal mesh 2 to increase its radial size, and finally achieve the state where the first connecting member 3 and the second connecting member cooperate to clamp the opposite sides of the oval foramen, and at the same time compress the elastic metal mesh 2 to completely block the oval foramen. At this time, the occluder can firmly block the oval foramen.

[0061] Furthermore, when the effect of driving the first connecting member 3 and the second connecting member 4 to move relative to each other is achieved, as Figure 2As shown, the scheme adopted in this embodiment is to make the push rod 5 a hollow tube body, and an auxiliary guide wire 10 is inserted into the push rod 5, and one end of the auxiliary guide wire 10 extends into the third part 8 and is detachably connected to the fourth part, or is detachably connected to the third part 8. For example, the auxiliary guide wire 10 is a non-metallic wire, and the second connecting member 4 is in the connection between the third part 8 and the fourth part, which can be specifically on the fourth part, or on the third part 8. The connecting member can be a connecting ring, a connecting hook, etc., which is not limited to the specific. One end of the auxiliary guide wire 10 extends into the tube body of the second connecting member 4 through the first connecting member 3 and is connected to the connecting member, such as being tied to the connecting member, or a connecting hook is set, and the connecting hook is hooked with the connecting member, etc., so as to realize the detachable connection between the auxiliary guide wire 10 and the second connecting member 4. Of course, in actual application, it is not limited to the above-mentioned connecting mechanism, which is only used as an example here. After the occluder is released, medical personnel can pull the second connecting member 4 through the auxiliary guide wire 10 to move it towards the direction close to the first connecting member 3, and at the same time compress the elastic metal mesh 2, so that the first connecting member 3 and the second connecting member 4 clamp the two sides of the oval foramen, and at the same time adjust the size of the elastic metal mesh 2 to match the oval foramen, thereby achieving the effect of firmly and stably blocking the oval foramen.

[0062] Optionally, in another embodiment, the third part 8 and the first part 6 are respectively provided with a stop structure 11 that can abut against each other. The specific structure of the stop structure 11 is not limited, for example, it can be but not limited to an annular convex rib, a columnar protrusion, etc., as long as it can abut against each other to limit the positional relationship of the two connectors, prevent the two connectors from moving excessively and causing the tube body of the first connector 3 to push the second slat 9 of the second connector 4, causing it to slip out of the tube body of the second connector 4. In addition, the setting of the stop structure 11 can also limit the movement of the two connectors, avoiding the two connectors from excessively clamping the two sides of the oval foramen and causing tissue trauma. The specific setting position of the stop structure 11 is not fixed, and it can preferably be a position that can just clamp and fix the tissue where the oval foramen is located, ensuring that the oval foramen is stably blocked and does not cause damage to the tissue, and at the same time can cause the auxiliary guide wire 10 to separate from the second connector 4. That is, when the medical staff pulls the auxiliary guide wire 10 to move the two connectors to the desired position to achieve the occlusion of the oval foramen, the pulling force on the auxiliary guide wire 10 just reaches the critical force required to separate from the second connector 4. At this time, the auxiliary guide wire 10 is pulled out while the occlusion of the oval foramen is completed. Of course, if the auxiliary guide wire 10 is made of a non-toxic material that can dissolve in the body, the medical staff can directly cut the auxiliary guide wire 10, so that it will automatically dissolve and disappear in the body.

[0063] The delivery catheter 1 in this embodiment is made of flexible material, such as an MPA catheter with an outer diameter of 5F (about 1.67mm). The inner diameter of the delivery catheter 1 can be, but not limited to, 1.52mm, and the length can be 100cm. However, since the delivery catheter 1 is soft and has insufficient support, it is not easy to move in the patient's body and is easy to deform. Figure 4 As shown, in this embodiment, an inner sheath 12 is provided in the delivery catheter 1 to support and guide the delivery catheter 1 to move to the oval foramen, and the inner sheath 12 is a hollow structure to form a channel inside. Preferably, the two ends of the inner sheath 12 in this embodiment are of different sizes, and the size of the internal channel is also different, that is, the end of the inner sheath 12 that first extends into the patient's body is slightly pointed to facilitate extending into the patient's body, and the channel in the inner sheath 12 can be, but is not limited to, allowing a commonly used J-head guidewire and an ultra-smooth guidewire to pass through.

[0064] The above embodiments are only exemplary embodiments of the present invention and are not intended to limit the present invention. The protection scope of the present invention is defined by the claims. Those skilled in the art may make various modifications or equivalent substitutions to the present invention within the essence and protection scope of the present invention, and such modifications or equivalent substitutions shall also be deemed to fall within the protection scope of the present invention.

Claims

1. A patent foramen ovale occlusion device, characterized in that: include: delivery catheter; An elastic metal mesh, the cross section of which is annular, can be stretched and contracted in the radial direction under the action of an external force, so that the elastic metal mesh can be contracted in the delivery catheter, and can be expanded to a state matching the size of the oval foramen after being extended out of the delivery catheter; A connecting component connected to both ends of the elastic metal mesh to support and limit the elastic metal mesh, wherein the connecting component is flexible and can be deformed to extend into the delivery conduit and can be restored to its original structural state when extending out of the delivery conduit; as well as A push rod, which can be inserted into the delivery catheter and detachably connected to the connection assembly, so as to cooperate with the delivery catheter to push the elastic metal mesh and the connection assembly to the oval foramen, and push the elastic metal mesh and the connection assembly out of the delivery catheter to cooperate to block the oval foramen; The connecting component includes a first connecting member and a second connecting member, the first connecting member and the second connecting member are respectively connected to the two ends of the elastic metal mesh, the pushing rod is detachably connected to the first connecting member, the pushing rod is a hollow tube, an auxiliary guide wire is inserted into the pushing rod, one end of the auxiliary guide wire extends into the second connecting member and is detachably connected to the second connecting member, when the connecting component and the elastic metal mesh extend out of the delivery catheter, the elastic metal mesh inflates and extends into the oval foramen, the first connecting member and the second connecting member are located on both sides of the oval foramen after being unfolded, the auxiliary guide wire is used to pull the second connecting member to move it in a direction close to the first connecting member, thereby clamping the two sides of the oval foramen and compressing the elastic metal mesh to block the oval foramen.

2. The patent foramen ovale occlusion device according to claim 1, characterized in that: The first connecting member includes a first part and a second part, the first part is vertically connected to the second part, and the first part and the second part are communicated with each other, and the pushing rod is detachably connected to the first part.

3. The patent foramen ovale occlusion device according to claim 2, characterized in that: The first part is tubular, and the second part is composed of at least two first slats, which are cross-arranged. The first slats are made of flexible metal so that the first slats can be bent and abut against the first part, and can be unfolded in a scattered shape. The first part passes through the second part, and the elastic metal mesh is sleeved on the first part and connected to the first part. One end of the push rod passes through the second part and extends into the first part.

4. The patent foramen ovale occlusion device according to claim 3, characterized in that: The first part is threadedly connected to the push rod.

5. The patent foramen ovale occlusion device according to claim 3, characterized in that: The second connecting member includes a third part and a fourth part, the third part is vertically connected to the fourth part, the third part is tubular, and the fourth part is composed of at least two second slats, and at least two second slats are cross-arranged. The second slats are made of flexible metal so that the second slats can be bent and abut against the third part, and can be unfolded in a scattered shape. The elastic metal mesh is sleeved on the third part and connected to it.

6. The patent foramen ovale occlusion device according to claim 5, characterized in that: At least part of the first part and the third part are mutually sleeved and can move relative to each other to get closer or farther away.

7. The patent foramen ovale occlusion device according to claim 6, characterized in that: One end of the auxiliary guide wire extends into the third part and is detachably connected to the fourth part.

8. The patent foramen ovale occlusion device according to claim 7, characterized in that: The third part and the first part are respectively provided with stop structures capable of abutting against each other.

9. The patent foramen ovale occlusion device according to claim 1, characterized in that: The delivery catheter is made of flexible material, and an inner sheath for supporting and guiding the delivery catheter to move to the foramen ovale is inserted into the delivery catheter, and the inner sheath is a hollow structure.

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