An occluder assembly with unlocking function

Abstract

The present invention relates to an occluder assembly with an unlocking function, comprising an occluder body, a connecting ring, and a pull wire. One side of the occluder body has a connecting rivet head. The connecting ring includes a connecting wire and a circular ring. One end of the connecting wire is connected to the circular ring, and the other end of the connecting wire is connected to the inner side of the occluder body. The connecting rivet head has a connecting channel. The inner end of the connecting channel is directly connected to the interior of the occluder body, and the outer end of the connecting channel is directly connected to the external space of the occluder body. The pull wire includes a first and a second interconnected wire segment. The first wire segment is connected to a micro blade, and the second wire segment has no functional additional structure. The second wire segment passes through the circular ring. In a natural state, the outer diameter of the circular ring is larger than the inner diameter of the outer end of the connecting channel. The circular ring is made of a tough material so that the circular ring can be deformed. The purpose of unlocking the occluder body is achieved, and subsequent recovery of the occluder body is facilitated.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an occluder assembly with an unlocking function. Background Art

[0002] Cardiovascular diseases mainly include heart diseases and vascular diseases; heart diseases mainly include congenital heart diseases including ventricular septal defect, atrial septal defect, patent ductus arteriosus, patent foramen ovale and other types; among vascular diseases, aortic dissection refers to the blood in the aortic cavity entering the middle layer of the aortic wall through the rupture of the aortic intima, forming a dissection.

[0003] Cardiovascular diseases can now be treated with minimally invasive surgery. For example, in congenital heart defects, occluders are used to occlude the defect lesions. Similarly, occluders are also used to occlude aortic dissection ruptures. With breakthroughs in material technology, occluders are moving from the earliest nickel-titanium alloy metal materials to biodegradable materials. Since biodegradable materials are relatively soft compared to metal nickel-titanium alloy materials, they are not easy to shape and have low clamping force. Therefore, it is often necessary to add a locking device to solve the problems of occluder molding and clamping force. However, locking devices often bring many risks to clinical practice. For example, after locking, the occluder shifts and needs to be recovered and released again. Due to the inability to unlock, it cannot be recovered; after locking, the occluder is not suitable and needs to be replaced. Due to the inability to unlock, the replacement device fails, and many other problems. Summary of the Invention

[0004] In view of this, the present invention provides an occluder assembly with an unlocking function. After the occluder body is locked, if the position of the occluder body does not meet the requirements, the second line segment can be pulled so that the micro blade on the first line segment passes through the ring, thereby cutting the ring, so that the cut connecting ring can more easily enter the connecting channel, thereby achieving the purpose of unlocking the occluder body and facilitating the subsequent recovery of the occluder body.

[0005] The technical solution adopted by the present invention is:

[0006] An occluder assembly with an unlocking function comprises an occluder body, a connecting ring, and a pull wire. One side of the occluder body has a connecting rivet head. The connecting ring comprises a connecting wire and a circular ring. One end of the connecting wire is connected to the circular ring, and the other end of the connecting wire is connected to the inner side of the occluder body. A communication channel is defined within the connecting rivet head. The inner end of the communication channel is directly connected to the interior of the occluder body, and the outer end of the communication channel is directly connected to the external space of the occluder body. The pull wire comprises a first and a second interconnected wire segment. The first wire segment is connected to a micro blade, and the second wire segment has no functional additional structure. The second wire segment passes through the circular ring.

[0007] In a natural state, the outer diameter of the ring is larger than the inner diameter of the outer end of the communication channel, and the ring is made of a tough material so that the ring can be deformed;

[0008] The occluder assembly has a first state, a second state and a third state;

[0009] In the first state, the ring is located in the occluder body, the overlap of the pull wire intersects with the ring, and the overlap is located on the second line segment, and the first line segment and the second line segment pass through the connecting channel;

[0010] In the second state, the ring is pulled out of the communication channel. Since the outer diameter of the ring is larger than the inner diameter of the distal end of the communication channel, the ring is confined to the outer side of the distal end of the connecting rivet head, and the occluder body is pulled to a locked state through the connecting line.

[0011] In the third state, the second line segment is pulled toward the proximal end, so that the micro blades on the first line segment cut the ring, thereby releasing the lock of the occluder body.

[0012] Preferably, the micro blade is a blade group, which includes multiple blades. The blades are embedded in the first line segment, and the cutting edges of the blades are radially outward. Along the first direction, the multiple blades are arranged at intervals, and the radial height of the blades gradually increases; wherein, the first direction is the extension direction of the pull wire, and is along the second line segment toward the first line segment.

[0013] Preferably, the number of the micro blades is one, and the micro blade is cylindrical, comprising a base plate and a side plate, the side plate is annular, the base plate is circular, one side edge of the side plate is connected to the outer edge of the base plate, a through hole is provided in the center of the base plate, the first line segment passes through the through hole and is fixedly connected to the base plate, the side plate is located on the second direction side of the base plate, a U-shaped notch is provided on the edge of the base plate, the opening of the U-shaped notch faces the second direction, a cutting edge is formed at the U-shaped notch, which is used to cut the connection between the circular ring and the connecting line; wherein, the second direction is the extension direction of the pull line, and is along the direction of the first line segment toward the second line segment.

[0014] Preferably, there are multiple U-shaped notches, and a cutting edge is formed at each of the U-shaped notches. Multiple U-shaped notches are evenly arranged in the circumferential direction of the side plate.

[0015] Preferably, the inner diameter of the connecting channel gradually decreases from the inside to the outside, the inner diameter of the inner end is larger than the preset size, and the inner diameter of the outer end is smaller than the preset size; wherein, in the natural state, the outer diameter of the ring is the preset size.

[0016] Preferably, the inner diameter of the inner end is 1.01-1.1 times the preset size, and the inner diameter of the outer end is 0.5-0.8 times the preset size.

[0017] Preferably, the occluder body comprises a skeleton and a bluff body sewn to the inside of the skeleton, the skeleton is woven from PDO wire, the connecting rivet head is made of PDO, and the connecting rivet head is hot-melt connected to the skeleton.

[0018] Preferably, the occluder body is a left atrial appendage occluder or an atrial septum occluder.

[0019] Beneficial effects of the present invention:

[0020] After the occluder body is implanted in place through the delivery device, the occluder body needs to be locked so that the shape of the occluder body after expansion is fixed and it can be stably anchored in the target position. After the occluder body is locked, if the position of the occluder body cannot meet the requirements, the occluder body needs to be unlocked and the occluder body needs to be recovered. In the present invention, when it is necessary to unlock, the second line segment is pulled toward the proximal side so that the first line segment can pass through the ring. The first line segment is provided with a micro blade, so that the micro blade can cut the ring to break the ring. The cut connecting ring can easily enter the connecting channel, thereby achieving the purpose of unlocking the occluder body and facilitating the subsequent recovery of the occluder body. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The above and other objects, features and advantages of the present invention will become more apparent through the following description of the embodiments of the present invention with reference to the accompanying drawings, in which:

[0022] Figure 1 is a schematic structural diagram of the occluder assembly in the second state;

[0023] Figure 2 This is a diagram of the coordination between the pull wire and the ring. Figure 1 ;

[0024] Figure 3 It is a schematic diagram of cutting with a cylindrical micro blade;

[0025] Figure 4 This is a diagram of a cylindrical microblade. Figure 2 ;

[0026] Figure 5 This is the structural diagram of the occluder assembly in the second state. Figure 2 ;

[0027] Figure 6 is a schematic structural diagram of the occluder assembly in the third state;

[0028] Figure 7is a schematic diagram of the atrial septal occluder;

[0029] Figure 8 This is a schematic diagram of a left atrial appendage occluder.

[0030] In the figure: 1. Occluder body; 2. Connecting ring; 3. Pull wire;

[0031] 11. Connecting rivet head; 12. Connecting channel;

[0032] 21. Connecting line; 22. Ring;

[0033] 31. First line segment; 32. Second line segment; 33. Blade; 34. Base plate; 35. Side plate; 36. U-shaped notch. DETAILED DESCRIPTION

[0034] The present invention is described below based on the following embodiments, but the present invention is not limited to these embodiments. In the following detailed description of the present invention, some specific details are described in detail. In order to avoid obscuring the essence of the present invention, well-known methods, processes, procedures, and components are not described in detail.

[0035] Furthermore, persons of ordinary skill in the art will appreciate that the figures provided herein are for illustration purposes only and are not necessarily drawn to scale.

[0036] Unless the context clearly requires otherwise, throughout the specification and claims, the words "include," "comprising," and similar words should be construed in an inclusive sense rather than an exclusive or exhaustive sense; that is, in the sense of "including but not limited to."

[0037] In the description of the present invention, it should be understood that the terms "first", "second", etc. are used for descriptive purposes only and should not be understood to indicate or imply relative importance. In addition, in the description of the present invention, unless otherwise specified, "plurality" means two or more.

[0038] In the present invention, in a surgical situation, the end farther from the operator is referred to as “distal” (the side closer to the heart), and the side closer to the operator is referred to as “proximal” (the side farther from the heart).

[0039] See also Figures 1-8The present invention provides an occluder assembly with an unlocking function, comprising an occluder body 1, a connecting ring 2 and a pull wire 3, wherein the occluder body 1 has a connecting rivet head 11 on one side, the connecting ring 2 includes a connecting wire 21 and a circular ring 22, one end of the connecting wire 21 is connected to the circular ring 22, and the other end of the connecting wire 21 is connected to the inner side of the occluder body 1, the connecting rivet head 11 has a connecting channel 12, the inner end of the connecting channel 12 is directly connected to the interior of the occluder body, and the outer end of the connecting channel 12 is directly connected to the external space of the occluder body 1, the pull wire 3 includes a first line segment 31 and a second line segment 32 connected to each other, the first line segment 31 is connected to a micro blade 33, and the second line segment 32 has no functional additional structure; the second line segment 32 passes through the circular ring 22.

[0040] In a natural state, the outer diameter of the ring 22 is larger than the inner diameter of the outer end of the communication channel 12 . The ring 22 is made of a tough material, so that the ring 22 can be deformed.

[0041] The occluder assembly has a first state, a second state and a third state.

[0042] In the first state, the ring 22 is located in the occluder body 1 , and the overlap of the pull wire 3 intersects with the ring 22 . The overlap is located at the second line segment 32 , and the first line segment 31 and the second line segment 32 pass through the connecting channel 12 .

[0043] In the second state, the ring 22 is pulled out from the communication channel 12 and is stuck on the outside of the connecting rivet head 11 , and the occluder body 1 is pulled to a locked state through the connecting wire 21 .

[0044] In the third state, the second line segment 32 is pulled toward the proximal end, so that the micro blades 33 on the first line segment 31 cut the ring 22 , thereby releasing the lock of the occluder body 1 .

[0045] Taking the atrial septal occluder as an example, the overall structure of the occluder body 1 (in the expanded state) is composed of two disc structures and a waist structure, and the two disc structures are located on both sides of the waist structure; during the operation, the occluder body 1 is transported to the position of the atrial septal defect through the conveying device, and the occluder body 1 is released, and the occluder body 1 is completely extended from the distal end of the conveying device (the occluder is in a strip shape at this time); at this time, the occluder assembly is in the first working position, and the two ends of the pull wire 3 pass through the connecting channel 12 respectively and pass out of the conveying device; the two ends of the pull wire 3 are pulled toward the proximal side as a whole, so that the pull wire 3 will pull the ring 22 toward the proximal side. Since the pull wire 3 passes through the connecting channel 12, the ring 22 will be pulled to the connecting channel 12. Since the ring 22 is made of tough material, that is, in the absence of external force, the ring 22 is circular as a whole, under pressure The ring 22 can be deformed under pressure and become an oval as a whole. Therefore, when the ring 22 passes through the connecting channel 12, it is restricted by the connecting channel 12 and the ring 22 is an oval ring, so that the ring 22 can smoothly pass through the connecting channel 12. After the ring 22 completely passes through the connecting channel 12, the ring 22 will return to a circle. After the ring 22 is pulled to the outside of the connecting rivet head 11, it will no longer enter the connecting channel 12. Since the ring 22 is connected to the occluder body through the connecting line 21, the ring 22 will simultaneously pull part of the occluder body 1 during the pulling process, causing the occluder body 1 to unfold. Due to the restriction (locking) of the ring 22 and the connecting rivet head 11, the occluder body 1 will no longer return to a strip shape, and the defective edge is clamped by two disks (expanded state) to achieve the purpose of anchoring (second state).

[0046] In the above section, after the occluder body 1 is unfolded and locked, if the position of the occluder body 1 meets the requirements, the occluder can be left behind and the conveying device can be withdrawn; if the position of the occluder body 1 does not meet the requirements, the occluder body 1 needs to be withdrawn. The premise for withdrawing the occluder body 1 is that the occluder body 1 must be able to return to the strip shape so that the occluder body 1 can be recovered into the conveying device. However, since the occluder body 1 is locked, the occluder body 1 cannot be restored to the strip shape, which requires unlocking the occluder body 1.

[0047] In the present invention, by pulling the second line segment 32 toward the proximal side and releasing the restriction on the first line segment 31 at the same time, since the second line segment 32 is connected to the first line segment 31, the second line segment 32 will pull the first line segment 31 through the ring 22. Since the first line segment 31 is provided with a micro blade 33, the micro blade 33 will pass through the ring 22, thereby cutting the ring 22. After the cutting, the ring 22 will basically no longer be restricted by the connecting rivet head 11. Therefore, the connecting ring 2 can be completely received in the interior of the occluder body 1, thereby releasing the lock on the occluder body 1, allowing the occluder body 1 to be restored to a strip shape, which is convenient for the subsequent recovery of the occluder body 1.

[0048] Preferably, the micro blade 33 is a blade 33 group, and the blade 33 group includes multiple blades 33. The blades 33 are embedded in the first line segment 31, and the cutting edges of the blades 33 face radially outward. Along the first direction, multiple blades 33 are arranged at intervals, and the radial height of the blades 33 gradually increases; wherein, the first direction is the extension direction of the pull wire 3, and is along the second line segment 32 toward the direction of the first line segment 31.

[0049] The pulling wire 3 is preferably a polymer wire, and a plurality of blades 33 are inlaid on the first line segment 31. The blade 33 is triangular, for example, a right triangle, and its hypotenuse is the cutting edge of the blade 33. Its right-angled long side is connected to the first line segment 31, and the direction of the right-angled long side is consistent with the extension direction of the first line segment 31, and the cutting edge faces the first direction; in the circumferential direction of the first line segment 31, all the blades 33 are located in the same position. When the second line segment 32 is pulled, multiple blades 33 will pass through the ring 22 in turn. Since the positions of the blades 33 in the circumferential direction are consistent, the blades 33 will cut the same position of the ring 22 in turn, thereby ensuring that the ring 22 can be cut off.

[0050] In addition, in the first direction, the radial height of the blade 33 gradually increases (the length of the short side of the right angle gradually increases), so that the next blade 33 cuts the ring 22 at a greater depth than the previous blade 33, and the next blade 33 cuts along the cutting position of the previous blade 33, thereby ensuring that the ring 22 is effectively cut and that the ring 22 can be cut off.

[0051] Of course, in the first direction, the plurality of blades 33 may be arranged at equal intervals or at unequal intervals.

[0052] The short right-angled sides of the blades 33 can also be cutting edges. Therefore, when all the blades 33 have passed through the ring 22, if the ring 22 is still not cut off, the first line segment 31 can be pulled toward the proximal side to make multiple blades 33 move in the opposite direction, and the short right-angled sides can be used to cut the ring 22. In this way, the second line segment 32 and the first line segment 31 can be pulled alternately to ensure that the ring 22 is cut off.

[0053] Since the ring 22 is cut off, the cut portion is no longer subject to mutual constraints, so that the ring 22 is strip-shaped as a whole. Therefore, the ring 22 is basically no longer restricted by the connecting rivet head 11, so that the ring 22 can enter the connecting channel 12 again, thereby achieving the purpose of unlocking the occluder body 1.

[0054] The number of blades 33 can be 3, 4 or 5.

[0055] In another optional embodiment, the number of the micro blades 33 is one, and the micro blade 33 is cylindrical, comprising a base plate 34 and a side plate 35, the side plate 35 being annular, the base plate 34 being circular, one side edge of the side plate 35 being connected to the outer edge of the base plate 34, a through hole being provided in the center of the base plate 34, the first line segment 31 passing through the through hole and being fixedly connected to the base plate 34, the side plate 35 being located on the second direction side of the base plate 34, a U-shaped notch 36 being provided on the edge of the base plate 34, the opening of the U-shaped notch 36 being facing the second direction, a cutting edge being formed at the U-shaped notch 36 for cutting the connection between the circular ring 22 and the connecting line 21; wherein, the second direction is the extension direction of the pull wire 3, and is along the direction of the first line segment 31 toward the second line segment 32.

[0056] The diameter of the base plate 34 can be slightly larger than the outer diameter of the ring 22. Therefore, when the second line segment 32 is pulled, the micro blade 33 moves along the second direction, so that the micro blade 33 gradually approaches the ring 22. When reaching the ring 22, the U-shaped notch 36 is aligned with the connection between the ring 22 and the connecting line 21, and the ring 22 enters the side plate 35. Continue to pull the second line segment 32, and the cutting edge at the U-shaped notch 36 will cut the connection between the ring 22 and the connecting line 21, so that the ring 22 is separated from the connecting line 21. In this way, the ring 22 will no longer pull the occluder body 1, thereby achieving the purpose of unlocking.

[0057] Furthermore, there are multiple notches, each of which forms a cutting edge, and multiple cutting edges are evenly arranged around the circumference of the side plate 35. When cutting, it is only necessary to ensure that one of the U-shaped notches 36 is aligned with the connection between the ring 22 and the connecting line 21 to achieve the purpose of cutting, thereby improving redundancy.

[0058] From inside to outside, the inner diameter of the communication channel 12 gradually decreases, the inner diameter of the inner end is larger than the preset size, and the inner diameter of the outer end is smaller than the preset size; wherein, in the natural state, the outer diameter of the ring 22 is the preset size.

[0059] When switching from the first state to the second state, the inner diameter of the inner end is larger than the preset size. When the pull wire 3 is pulled, the ring 22 can easily enter the inner end. Continue to pull the pull wire 3, and the inner diameter of the connecting channel 12 gradually becomes smaller, thereby gradually compressing the ring 22, making the ring 22 become elliptical, thereby more conveniently guiding the ring 22 to pass through the connecting channel 12.

[0060] The inner diameter of the inner end is 1.01-1.1 times the preset size, and the inner diameter of the outer end is 0.5-0.8 times the preset size.

[0061] The occluder body 1 includes a skeleton and a bluff body sewn into the skeleton. The skeleton is woven from PDO wires. The connecting rivet head 11 is made of PDO. The connecting rivet head 11 is hot-melt connected to the skeleton.

[0062] Of course, the skeleton can also be woven from nickel-titanium alloy wires, in which case the connecting rivet head 11 and the skeleton are woven together.

[0063] The occluder body 1 is a left atrial appendage occluder or an atrial septum occluder.

[0064] It should be understood that the above-mentioned embodiments are merely illustrative and non-restrictive. Without departing from the basic principles of the present invention, various obvious or equivalent modifications or substitutions that can be made by those skilled in the art to the above-mentioned details will be included in the scope of the claims of the present invention.

Claims

1. An occluder assembly with an unlocking function, characterized in that: The device comprises an occluder body, a connecting ring and a pull wire. One side of the occluder body has a connecting rivet head. The connecting ring includes a connecting wire and a circular ring. One end of the connecting wire is connected to the circular ring, and the other end of the connecting wire is connected to the inner side of the occluder body. A communication channel is defined in the connecting rivet head. The inner end of the communication channel is directly connected to the interior of the occluder body, and the outer end of the communication channel is directly connected to the external space of the occluder body. The pull wire includes a first and a second interconnected wire segment. The first wire segment is connected to a micro blade, and the second wire segment has no functional additional structure. The second wire segment passes through the circular ring. In a natural state, the outer diameter of the ring is larger than the inner diameter of the outer end of the communication channel, and the ring is made of a tough material so that the ring can be deformed; The occluder assembly has a first state, a second state and a third state; In the first state, the ring is located in the occluder body, the overlap of the pull wire intersects with the ring, and the overlap is located on the second line segment, and the first line segment and the second line segment pass through the connecting channel; In the second state, the ring is pulled out of the communication channel. Since the outer diameter of the ring is larger than the inner diameter of the distal end of the communication channel, the ring is confined to the outer side of the distal end of the connecting rivet head, and the occluder body is pulled to a locked state through the connecting line. In the third state, the second line segment is pulled toward the proximal end, so that the micro blades on the first line segment cut the ring, thereby releasing the lock of the occluder body.

2. The occluder assembly with unlocking function according to claim 1, characterized in that: The micro blade is a blade group, which includes multiple blades. The blades are embedded in the first line segment, and the cutting edges of the blades face radially outward. Along the first direction, multiple blades are arranged at intervals, and the radial height of the blades gradually increases; wherein, the first direction is the extension direction of the pull wire, and is the direction along the second line segment toward the first line segment.

3. The occluder assembly with unlocking function according to claim 1, characterized in that: The number of the micro blades is one, and the micro blade is cylindrical, comprising a base plate and a side plate, the side plate being annular, the base plate being circular, one side edge of the side plate being connected to the outer edge of the base plate, a through hole being provided in the center of the base plate, the first line segment passing through the through hole and being fixedly connected to the base plate, the side plate being located on the second direction side of the base plate, a U-shaped notch being provided on the edge of the base plate, the opening of the U-shaped notch facing the second direction, a cutting edge being formed at the U-shaped notch for cutting the connection between the circular ring and the connecting line; wherein, the second direction is the extension direction of the pull line, and is along the direction of the first line segment toward the second line segment.

4. The occluder assembly with unlocking function according to claim 3, characterized in that: There are multiple U-shaped notches, and a cutting edge is formed at each of the U-shaped notches. In the circumferential direction of the side plate, multiple U-shaped notches are evenly arranged.

5. The occluder assembly with unlocking function according to any one of claims 1 to 4, characterized in that: From the inside to the outside, the inner diameter of the connecting channel gradually decreases, the inner diameter of the inner end is larger than the preset size, and the inner diameter of the outer end is smaller than the preset size; wherein, in the natural state, the outer diameter of the ring is the preset size.

6. The occluder assembly with unlocking function according to claim 5, characterized in that: The inner diameter of the inner end is 1.01-1.1 times the preset size, and the inner diameter of the outer end is 0.5-0.8 times the preset size.

7. The occluder assembly with unlocking function according to claim 6, characterized in that: The occluder body includes a frame and a bluff body sewn into the frame. The frame is woven from PDO wires. The connecting rivet head is made of PDO. The connecting rivet head is hot-melt connected to the frame.

8. The occluder assembly with unlocking function according to claim 1, characterized in that: The occluder body is a left atrial appendage occluder or an atrial septum occluder.

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