Biodegradable patent foramen ovale plugging device with biocompatible coating

Abstract

The invention relates to the technical field of medical instruments, and discloses a biodegradable patent foramen ovale plugging device with a biocompatible coating, which comprises a plugging piece I, a plugging piece II, a connecting part and a frame wound outside the plugging piece I and the plugging piece II, the plugging piece I, the connecting part and the plugging piece II are connected in sequence to form a plugging device main body with a non-closed circular hole; a first jacking assembly used for supporting is installed in the first plugging piece, a second jacking assembly used for supporting is installed in the second plugging piece, a connecting rod is fixed to the inner side of the first plugging piece, and a clamping base connected with the connecting rod in a clamped mode is installed on the outer side of the second plugging piece. According to the patent foramen ovale plugging device, the connecting rod serves as the end connected with the outside, protrusions of the connecting ends of the two outer sides of the plugging piece are reduced, and therefore the situation that the degradation rates of the connecting ends are inconsistent in the degradation process can be avoided, and the using effect and the function stability of the patent foramen ovale plugging device are guaranteed.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, in particular to a biodegradable patent foramen ovale occluder with a biocompatible coating. Background Art

[0002] The foramen ovale is formed during the 6th to 7th week of embryonic development, during which the atrial septum develops two septa in sequence: the primum septum (first septum) and the secundum septum (second septum). The primum septum grows in a semilunar shape from the dorsal wall of the atrial midline, grows toward the atrioventricular canal and fuses with the endocardial cushions, leaving a small hole at the caudal end of the atrioventricular septum, called the primum septum. Before the closure of the primum septum, a hole is formed in the proximal part of the primum septum, called the secundum septum, which is the normal channel for blood circulation during the fetal period. At the same time, on the right side of the primum septum, a sickle-shaped septum grows on the atrial wall, called the secundum septum (second septum). The secundum septum does not continue to grow to completely separate the atria, but stops halfway, forming an oval depression called the fossa ovalis. The septum primum and septum secundum at the fossa ovalis fail to adhere and fuse, leaving a small gap called the foramen ovale. When a newborn is born, with the first cry, the pressure in the left atrium rises, causing the left primary septum to adhere to the right secondary septum, resulting in functional closure, which usually reaches anatomical closure within 1 year. If the foramen ovale of a child over 3 years old has not closed, it is called patent foramen ovale. In adults, about 20% to 25% of foramina ovale are not completely closed. Patent foramen ovale is currently the most common congenital heart abnormality in adults, and about 1 in 4 people in the normal population can be found to suffer from this disease.

[0003] Studies in recent years have shown that there is a close connection between patent foramen ovale and patients with unexplained stroke. This is because through the patent foramen ovale, emboli from the right heart system can enter the left heart system, causing corresponding clinical symptoms, such as thrombosis of the deep veins of the lower limbs or pelvic veins, air emboli caused by diving sickness or decompression sickness, and fat emboli formed after surgery or trauma. Moreover, for patients with patent foramen ovale who have experienced thrombotic events, the risk of recurrence is still very high. Therefore, targeted treatment of the cause and closing the open foramen ovale in high-risk groups are expected to reduce the incidence of patients. In addition, patent foramen ovale is also related to the onset of decompression sickness, migraine, etc.

[0004] An obvious technical problem with the current patent foramen ovale occluder is the design of its connection end. The existence of the connection end leads to unstable degradation behavior and functional performance of the occluder in actual use. Specifically, the connection end usually has a different thickness from the rest of the occluder and is structurally prominent.

[0005] The difference in thickness between the connector and the rest of the occluder can cause inconsistent degradation rates. Due to the different material thicknesses of the connector, its degradation process does not match the degradation rate of the main body of the occluder. This inconsistency causes some parts of the occluder to degrade too quickly or too slowly during use, thus affecting the functional performance and long-term effects of the occluder. Summary of the invention

[0006] In view of the deficiencies in the prior art, the present invention provides a biodegradable patent foramen ovale occluder with a biocompatible coating, which solves the problem that the existing patent foramen ovale occluder has obvious connecting ends, resulting in inconsistent degradation rates.

[0007] To achieve the above objectives, the present invention is implemented through the following technical solutions: a biodegradable patent foramen ovale occluder with a biocompatible coating, comprising an occluding member 1, an occluding member 2, a connecting portion and a frame wrapped around the outside of the occluding member 1 and the occluding member 2, wherein the occluding member 1, the connecting portion and the occluding member 2 are connected in sequence to form the main body of the patent foramen ovale occluder; a supporting jacking assembly 1 is installed inside the occluding member 1, a supporting jacking assembly 2 is installed inside the occluding member 2, a connecting rod is fixed on the inner side of the occluding member 1, and a clamping seat clamped with the connecting rod is installed on the outer side of the occluding member 2.

[0008] Preferably, the supporting assembly includes a restraining member, the restraining member is fixed to an inner wall of the blocking member, and an open end of the restraining member abuts against an inner wall of the blocking member.

[0009] Preferably, the supporting assembly 1 further comprises an elastic member 1, wherein the elastic member 1 is mounted on an inner wall of the blocking member 1, and an open end of the elastic member 1 abuts against an outer wall of the constricting member 1.

[0010] Preferably, the second supporting assembly comprises a second elastic member, the second elastic member is fixedly connected to the inner wall of the second blocking member, and the open end of the second blocking member abuts against the inner wall of the second blocking member.

[0011] Preferably, the second supporting assembly further comprises a second constricting member, the second constricting member is mounted on the inner wall of the second blocking member, and the open end of the second elastic member abuts against the inner wall of the second elastic member.

[0012] Preferably, the jacking component one and the jacking component two are arranged opposite to each other.

[0013] Preferably, a mounting groove is provided on the outer side of the second blocking member, and the clamping seat is installed on the side wall of the mounting groove.

[0014] Preferably, a plurality of clamping grooves are provided on the outer circumference of the connecting rod, a clamping opening is provided in the middle of the clamping seat, and the end of the clamping seat abuts against the inner wall of the clamping groove.

[0015] Preferably, the snap-fit ​​groove includes snap-fit ​​surface one, snap-fit ​​surface two and snap-fit ​​surface three, and the snap-fit ​​surface one, snap-fit ​​surface two and snap-fit ​​surface three are connected in sequence, the snap-fit ​​surface two is horizontal, the snap-fit ​​surface three is vertical, the snap-fit ​​surface one is inclined, and the inclination angle is adapted to the size of the open end of the snap-fit ​​seat.

[0016] Preferably, the patent foramen ovale occluder is entirely made of a material that can be absorbed by the human body, and a biocompatible coating is sprayed on the outer surface.

[0017] Working principle: When in use, the patent foramen ovale occluder is squeezed first and then placed in the catheter, and then the catheter is pushed to the heart through puncture. When the catheter reaches the foramen ovale position between the right atrium and the right atrium of the heart, the patent foramen ovale occluder is pushed out. At this time, the occluding piece 1 will be unfolded under the action of the contracting piece 1, and then the catheter is retracted to the other side of the foramen ovale, and the occluding piece 2 will be released. The occluding piece 2 will be unfolded under the action of the contracting piece 2 and the elastic piece 2. At this time, the connecting rod will also be docked with the clamping seat, and finally the connecting rod will be pulled toward the direction of the occluding piece 2, first acting on the clamping seat to make the open end of the clamping seat move along the clamping seat. The mouth is deformed, and when the clamping seat reaches the clamping groove position, the clamping seat contracts to clamp with the clamping groove, thereby completing the installation of the entire patent foramen ovale occluder, and at the same time, the elastic member 2 and the elastic member 1 can be driven to be squeezed while pulling the connecting rod, so that the blocking member 2 and the blocking member 1 are more fully abutted against the two sides of the oval foramen, thereby ensuring the stability of the installation, and at the same time, the catheter is directly connected to the connecting rod to reduce the protrusion of the connecting end, thereby avoiding the falling of foreign matter caused by the slow dissolution rate of the connecting end during the degradation and absorption process, thereby ensuring the use effect and functional stability of the patent foramen ovale occluder.

[0018] The invention provides a biodegradable patent foramen ovale occluder with a biocompatible coating.

[0019] It has the following beneficial effects:

[0020] 1. The present invention uses the connecting rod as the end connected to the outside to reduce the protrusion of the two outer connecting ends of the occluding member, thereby avoiding the situation where the degradation rate of the connecting ends is inconsistent during the degradation process, thereby ensuring the use effect and functional stability of the patent foramen ovale occluder.

[0021] 2. The present invention installs elastic member 1 and elastic member 2 inside the sealing member 1 and the sealing member 2 to provide support for the closing member 1 and the closing member 2, and squeezes the sealing member 1 and the closing member 2 toward the side wall of the oval foramen through the deformation of the elastic member 1 and the elastic member 2 themselves, thereby improving the stability after installation. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 A perspective view of the present invention;

[0023] Figure 2 It is a side perspective view of the present invention;

[0024] Figure 3 It is a schematic diagram of the cross-sectional structure of the present invention;

[0025] Figure 4 It is a structural schematic diagram of the connecting rod in the present invention;

[0026] Figure 5 It is an exploded schematic diagram of the position of the card connector in the present invention;

[0027] Figure 6 for Figure 3 Enlarged view of point A in the middle.

[0028] Among them, 1. Sealing part 1; 2. Sealing part 2; 3. Connecting part; 4. Frame; 5. Closing part 1; 6. Elastic part 1; 7. Closing part 2; 8. Elastic part 2; 9. Connecting rod; 10. Snap-fit ​​seat; 11. Mounting groove; 12. Bayonet; 13. Snap-fit ​​groove; 131. Snap-fit ​​surface 1; 132. Snap-fit ​​surface 2; 133. Snap-fit ​​surface 3. DETAILED DESCRIPTION

[0029] The following will be combined with the drawings in the specification of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0030] Example:

[0031] Please see attached Figure 1 -Attached Figure 3The embodiment of the present invention provides a biodegradable patent foramen ovale occluder with a biocompatible coating, comprising an occluding member 1, an occluding member 2, a connecting portion 3 and a frame 4 wrapped around the outside of the occluding member 1 and the occluding member 2. The occluding member 1, the connecting portion 3 and the occluding member 2 are sequentially connected to form a main body of the patent foramen ovale occluder. The occluding member 1, the occluding member 2 and the connecting portion 3 are integrally formed and connected through the external frame 4. After the patent foramen ovale occluder passes through the position of the occluding member, the occluding member 1 and the occluding member 2 are deformed. To respectively approach the two sides of the oval foramen, and complete the installation of the oval foramen occluder by squeezing; a supporting top support component 1 is installed inside the occluding piece 1, and the supporting top support component 1 can unfold the occluding piece 1 after deformation and squeeze it toward the oval foramen; a supporting top support component 2 is installed inside the occluding piece 2, and the supporting top support component 2 can unfold the occluding piece 2 after deformation and squeeze it toward the oval foramen; after the occluding pieces 1 and 2 are fully unfolded, the frame 4 can be squeezed to ensure that the frame 4 fully fits the side of the oval foramen. A connecting rod 9 is fixed on the inner side of the blocking piece 1, and a clamping seat 10 clamped with the connecting rod 9 is installed on the outer side of the blocking piece 2. The connecting rod 9 is connected to an external guide component. This guide component can be but not limited to a wire drawing in a catheter. After the blocking piece 1 and the blocking piece 2 are unfolded, the connecting rod 9 will also abut against the clamping seat 10. Under the action of the external wire drawing, the connecting rod 9 and the clamping seat 10 are clamped, thereby completing the installation and fixation of the entire patent foramen ovale occluder.

[0032] Please see attached Figure 3 The top supporting assembly 1 includes a contracting member 5, which is fixed to the inner wall of the plugging member 1, and the open end of the contracting member 5 abuts against the inner wall of the plugging member 1. The end of the contracting member 5 fixed to the plugging member 1 provides a force for deformation of the contracting member 5. After the plugging member 1 is unfolded, the contracting member 5 unfolds under its own action. After unfolding, the outer edge of the contracting member 5 acts on the center position of the plugging member 1 to make the plugging member 1 more fully extended. The top supporting assembly 1 also includes an elastic member 6, which is installed on the inner wall of the plugging member 1, and the open end of the elastic member 6 abuts against the outer wall of the contracting member 5. After the patent foramen ovale occluder is unfolded, the elastic member 6 will be squeezed by the inner wall of the plugging member 1 to act on the outer side of the contracting member 5, thereby making the contracting member 5 more closely fit the inner wall of the plugging member 1, thereby ensuring the stability of the structure of the plugging member 1 after unfolding.

[0033] Please see attached Figure 3The top supporting component 2 includes an elastic member 28, which is fixedly connected to the inner wall of the blocking component 22, and the open end of the blocking component 22 abuts against the inner wall of the blocking component 22. The closing member 27 has the same function as the closing member 15. After the blocking component 22 is unfolded, the closing member 22 is more fully extended by the closing member 27. The top supporting component 2 also includes a closing member 27, which is installed on the inner wall of the blocking component 22, and the open end of the elastic member 28 abuts against the inner wall of the elastic member 28. The function of the elastic member 28 is the same as that of the elastic member 16. After the blocking component 22 is unfolded and the connecting rod 9 is tightened, the elastic member 16 will push the closing member 27 outward under the action of itself and the limitation of the connecting part 3, to ensure that the closing member 27 is fully unfolded, thereby ensuring the stability of the structure of the blocking component 22 after it is unfolded.

[0034] The supporting components 1 and 2 are arranged relative to each other, which can ensure that after the patent foramen ovale occluder is deployed, the sealing component 1 and the sealing component 2 can fully contact the outer side of the foramen ovale, thereby ensuring the sealing effect of the foramen ovale.

[0035] Please see attached Figure 3 -Attached Figure 6 , the outer side of the plugging member 2 is provided with a mounting groove 11, and the clamping seat 10 is installed on the side wall of the mounting groove 11. After adding the mounting groove 11, the excessive protrusion of the connecting rod 9 after installation can be avoided, thereby avoiding the appearance of foreign matter due to the different degradation rates of the patent foramen ovale occluder. A plurality of clamping grooves 13 are provided on the outer periphery of the connecting rod 9, and a bayonet 12 is provided in the middle of the clamping seat 10. The end of the clamping seat 10 abuts against the inner wall of the clamping groove 13. After the connecting rod 9 passes through the middle of the clamping seat 10, the connecting rod 9 is pulled toward the plugging member 2. The connecting rod 9 first acts on the clamping seat 10 to deform and expand the open end of the clamping seat 10 along the bayonet 12. After the clamping seat 10 reaches the position of the clamping groove 13, the clamping seat 10 shrinks to clamp with the clamping groove 13, thereby completing the installation of the entire patent foramen ovale occluder. The snap-fit ​​groove 13 includes a snap-fit ​​surface 131, a snap-fit ​​surface 132 and a snap-fit ​​surface 3 133, which are connected in sequence. The snap-fit ​​surface 132 is horizontal, the snap-fit ​​surface 3 133 is vertical, the snap-fit ​​surface 131 is inclined, and the inclination angle is adapted to the size of the open end of the snap-fit ​​seat 10. Through the shape effect of the snap-fit ​​surface 131, the snap-fit ​​surface 132 and the snap-fit ​​surface 3 133, the snap-fit ​​seat 10 can approach the direction of the occluding member 1, but cannot retreat, thereby improving the stability of the patent foramen ovale occluder after installation.

[0036] The patent foramen ovale occluder is made of human-absorbable material and can be degraded and absorbed inside the heart, thereby reducing the number of surgeries. The outer surface is sprayed with a biocompatible coating to reduce the body's rejection reaction.

[0037] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A biodegradable patent foramen ovale occluder with a biocompatible coating, comprising an occluding member 1 (1), an occluding member 2 (2), a connecting portion (3), and a frame (4) wound around the occluding member 1 (1) and the occluding member 2 (2), It is characterized in that The blocking piece 1 (1), the connecting part (3) and the blocking piece 2 (2) are connected in sequence to form a main body of the circular hole unclosed blocking device; the blocking piece 1 (1) is internally installed with a supporting top support component 1, and the blocking piece 2 (2) is internally installed with a supporting top support component 2; a connecting rod (9) is fixed on the inner side of the blocking piece 1 (1), and a clamping seat (10) clamped with the connecting rod (9) is installed on the outer side of the blocking piece 2 (2).

2. The biodegradable patent foramen ovale occluder with a biocompatible coating according to claim 1, It is characterized in that The supporting assembly 1 comprises a cinching member 1 (5), the cinching member 1 (5) is fixed to the inner wall of the blocking member 1 (1), and the open end of the cinching member 1 (5) abuts against the inner wall of the blocking member 1 (1).

3. The biodegradable patent foramen ovale occluder with a biocompatible coating according to claim 1, It is characterized in that The supporting assembly 1 also includes an elastic member 1 (6), which is installed on the inner wall of the blocking member 1 (1), and the open end of the elastic member 1 (6) is in contact with the outer wall of the contracting member 1 (5).

4. The biodegradable patent foramen ovale occluder with a biocompatible coating according to claim 1, It is characterized in that The second supporting assembly comprises a second elastic member (8), the second elastic member (8) is fixedly connected to the inner wall of the second blocking member (2), and the open end of the second blocking member (2) abuts against the inner wall of the second blocking member (2).

5. The biodegradable patent foramen ovale occluder with a biocompatible coating according to claim 4, It is characterized in that The second supporting assembly further comprises a second closure member (7), which is mounted on the inner wall of the second blocking member (2), and the open end of the second elastic member (8) is in contact with the inner wall of the second elastic member (8).

6. The biodegradable patent foramen ovale occluder with a biocompatible coating according to claim 1, It is characterized in that The first supporting component and the second supporting component are arranged opposite to each other.

7. The biodegradable patent foramen ovale occluder with a biocompatible coating according to claim 1, It is characterized in that An installation groove (11) is provided on the outer side of the second sealing member (2), and the clamping seat (10) is installed on the side wall of the installation groove (11).

8. The biodegradable patent foramen ovale occluder with a biocompatible coating according to claim 1, It is characterized in that The outer circumference of the connecting rod (9) is provided with a plurality of clamping grooves (13), the middle of the clamping seat (10) is provided with a clamping opening (12), and the end of the clamping seat (10) abuts against the inner wall of the clamping groove (13).

9. The biodegradable patent foramen ovale occluder with a biocompatible coating according to claim 8, It is characterized in that The snap-fit ​​groove (13) comprises a snap-fit ​​surface 1 (131), a snap-fit ​​surface 2 (132) and a snap-fit ​​surface 3 (133); the snap-fit ​​surface 1 (131), the snap-fit ​​surface 2 (132) and the snap-fit ​​surface 3 (133) are connected in sequence; the snap-fit ​​surface 2 (132) is horizontal, the snap-fit ​​surface 3 (133) is vertical, the snap-fit ​​surface 1 (131) is inclined, and the inclination angle is adapted to the size of the open end of the snap-fit ​​seat (10).

10. The biodegradable patent foramen ovale occluder with a biocompatible coating according to claim 1, It is characterized in that The patent foramen ovale occluder is made entirely of human-absorbable material, and a biocompatible coating is sprayed on the outer surface.

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