A PFO closure device with a centering structure

Abstract

This application relates to the field of medical devices, and particularly to a PFO closure device with a centering structure for closing a passage between a first tissue and a second tissue, including a centering structure and a needle insertion assembly. The centering structure includes a guide member, a guiding member, a first centering member, and a second centering member. The proximal ends of the guiding member, the first centering member, and the second centering member are connected to each other, and the distal end of the guiding member is connected to the needle insertion assembly. Moreover, the guide member is detachably connected to the middle or distal part of the first centering member and the middle or distal part of the second centering member.

Description

Technical Field

[0001] This application relates to the field of medical devices, and particularly to a PFO closure device with a centering structure. Background Art

[0002] The patent foramen ovale is a fissure located at the junction of the primary septum and the secondary septum of the interatrial septum. It is a blood supply channel in the heart formed during embryonic development. After birth, the blood supply channel changes and the patent foramen ovale closes naturally. If the patent foramen ovale has not closed by the age of 3, it is called patent foramen ovale not closed. Approximately 25% of the population has patent foramen ovale not closed. In recent years, with the continuous in-depth research on patent foramen ovale not closed, various clinical syndromes caused by patent foramen ovale not closed have received increasing clinical attention, including cryptogenic stroke, transient ischemic attack, migraine, platypnea-orthodeoxia syndrome, sleep apnea syndrome, myocardial infarction with normal coronary arteries, and decompression sickness. Especially cryptogenic stroke and migraine not only cause great physical pain and mental torture to patients, but also bring a heavy burden to families and society.

[0003] Common treatment methods for patent foramen ovale not closed include implanting a double-disk structure or suturing the unclosed channel. Since a relatively large piece of indigestible device will remain in the heart after the occlusion disk is implanted, it is not conducive to the recovery of patients and will affect other surgical treatments. Clinically, the suture method is often recommended.

[0004] Patent 202210946389.3 discloses a repair system facilitating puncture, which at least includes a double-puncture structure, a capture device, and a repair member. At least part of the repair member is sleeved in the double-puncture structure. The double-puncture structure can puncture two tissues with a gap back and forth during the repair process, and the capture device is arranged on the side of the first puncture starting point of the double-puncture structure and abuts against the tissue during the repair process, providing a supporting force for the tissue to be punctured for the second time by the double-puncture structure. Moreover, the double-puncture structure delivers the repair member to the target position during the puncture process, and the repair member connects the two punctured tissues to reduce or eliminate the gap. The design defects of this solution are as follows: First, when puncturing the secondary septum, it is impossible to ensure that the puncture point is located in the central area of the secondary septum, thus affecting the occlusion effect after single suture. Second, the puncture tube has no guiding structure, which will lead to instability, shaking, or displacement during puncture.

[0005] In summary, the following problems urgently need to be solved in the prior art: how to ensure puncture in the middle area of the target tissue, especially in the ideal area closer to the center, and be able to perform stable puncture without displacement. Summary of the Invention

[0006] In view of the above and other more ideas, this application is proposed.

[0007] One of the objectives of the present application is to overcome the deficiencies of the prior art. A closed instrument with a centering structure is provided to address the problems in the prior art where a closed instrument cannot simultaneously ensure puncture in the central area of the tissue and stable needle insertion without displacement during puncture.

[0008] The objective of the present invention is achieved through the following solutions:

[0009] A PFO closed instrument with a centering structure for closing a channel between a first tissue and a second tissue, including a pilot piece and a needle assembly. The centering structure includes a pilot piece, a guide piece, a first centering piece, and a second centering piece. The proximal ends of the guide piece, the first centering piece, and the second centering piece are connected to each other, and the distal end of the guide piece is connected to the needle assembly. Moreover, the pilot piece is detachably connected to the middle or distal end of the first centering piece and the middle or distal end of the second centering piece.

[0010] The objective of the present invention can also be further achieved through the following technical solutions:

[0011] In one embodiment, the first centering piece includes a first bending portion and a first connecting portion, and the second centering piece includes a second bending portion and a second connecting portion. The first connecting portion and the second connecting portion are detachably connected to the pilot piece. When the first connecting portion and the second connecting portion are connected to the pilot piece, the centering structure forms a closed loop, and the first bending portion and the second bending portion arch towards both sides. When the first connecting portion and the second connecting portion are separated from the pilot piece, the centering structure forms an open loop.

[0012] In one embodiment, the second connecting portion and the first connecting portion are sequentially sleeved outside the pilot piece, and the first connecting portion is located at the distal end of the second connecting portion.

[0013] In one embodiment, the length of the first centering piece is greater than the length of the second centering piece.

[0014] In one embodiment, the distal end of the guide piece is connected to the needle assembly, and the plane where the distal end of the guide piece is located intersects with the first bending portion and the second bending portion.

[0015] In another embodiment, the distal end of the guide piece is connected to the needle assembly, and the plane where the distal end of the guide piece is located is parallel to the first bending portion and the second bending portion.

[0016] In one embodiment, a needle insertion area is formed between the first bending portion and the second bending portion.

[0017] In one embodiment, the guide member is withdrawn, and the first connection portion and the second connection portion are detached from the guide member, wherein the first connection portion is a free end portion of the first centering member; and the first connection portion is detached from the guide member before the second connection portion.

[0018] In one embodiment, the distal end and the proximal end of the first connecting part, and the distal end and the proximal end of the second connecting part are both provided with guiding structures, and the guiding structures facilitate the delivery and withdrawal of the centering structure in a preset channel and / or human tissue.

[0019] In one embodiment, the guide structure is cylindrical or channel-shaped.

[0020] In one embodiment, the second connecting portion is a free end portion of the second centering member.

[0021] In one embodiment, when the first connecting portion is detached from the guide member, the first curved portion swings in a direction away from the guide member; when the second connecting portion is detached from the guide member, the second curved portion swings in a direction away from the guide member, and the swinging direction of the first curved portion is opposite to the swinging direction of the second curved portion.

[0022] In one embodiment, when the first curved portion and the second curved portion swing toward both sides, the oval foramen passage is expanded and stretched into a flat shape.

[0023] In one embodiment, the first curved portion includes a first outward expansion section, a first arc section and a first convergent section arranged in sequence from the proximal end to the distal end, and the second curved portion includes a second outward expansion section, a second arc section and a second convergent section arranged in sequence from the proximal end to the distal end.

[0024] In one embodiment, the plane where the distal end of the guide member is located intersects with the first arc portion and the second arc portion.

[0025] In one embodiment, when the first connecting portion, the second connecting portion and the guide member are connected, the first gathering section and the second gathering section form a first angle, and at this time, the first angle is less than 40°.

[0026] In one embodiment, the first angle is an acute angle; and after the first curved portion and the second curved portion are separated from the guide member, the first angle becomes smaller or the first gathering section is parallel to the second gathering section.

[0027] In another embodiment, the first angle is a right angle.

[0028] In another embodiment, the first angle is an obtuse angle.

[0029] In one embodiment, the centering structure further includes a sleeve member, which is located at the proximal end of the centering structure, the guide member, the first centering member and the second centering member are all connected to the sleeve member, and the first centering member and the second centering member are circumferentially arranged opposite to each other.

[0030] In one embodiment, after the first curved portion and the second curved portion are separated from the guide member, the first retracted segment and the second retracted segment expand the oval foramen channel, and the guide member and the sleeve member are automatically located in the central area of ​​the proximal surface of the secondary septum.

[0031] In one embodiment, the centering structure includes an adjusting piece, and a limiting connection structure is provided on the first arc segment and / or the second arc segment, and the adjusting piece is connected to the limiting connection structure; and pulling the adjusting piece can change the curvature of the first arc segment and / or the second arc segment.

[0032] In one embodiment, when the adjusting member is pulled, the first angle increases.

[0033] In another embodiment, a limiting connection structure is provided on the first arc segment and the second arc segment, and the adjusting member is connected to the limiting connection structure. When the adjusting member is pulled toward the proximal end, the first centering member and the second centering member will move toward the proximal end, and at the same time, the first arc segment and the second arc segment will be stretched toward both sides, so that the foramen ovale channel is unfolded and flattened, and the guide member is located in the central area of ​​the proximal surface of the secondary septum.

[0034] In one embodiment, the guide member is on a symmetric plane of both the first centering member and the second centering member.

[0035] In one embodiment, the closure device further comprises a delivery tube, wherein the delivery tube is connected to the sleeve member, and the delivery tube is sleeved outside the guide member.

[0036] In one embodiment, in a natural state, the guide member is parallel to the center line of the delivery tube.

[0037] In one embodiment, the horizontal distance between the guide member and the first curved portion and the second curved portion is small.

[0038] In one embodiment, the closure device further comprises a pre-installed tube, and the centering structure, the delivery tube and the needle assembly are sleeved in the pre-installed tube.

[0039] In one embodiment, the centering structure further includes a reinforcing unit connected to the first outwardly expanding section and the second outwardly expanding section, and at least a part of the reinforcing unit coincides with the guiding member on the projection plane.

[0040] In one embodiment, the reinforcing unit prevents the first outwardly expanding section and the second outwardly expanding section from being excessively deformed.

[0041] In one embodiment, the guiding member includes a limiting opening and a connecting hole, the needle inserting assembly includes a abutting tube and a needle inserting tube, the abutting tube is connected to the connecting hole, and the abutting tube moves within the limiting opening.

[0042] In one embodiment, the movement trajectory of the abutting tube forms a first plane, and the first plane is perpendicular to the plane where the first centering member and the second centering member are located.

[0043] In one embodiment, a suture member is provided inside the needle inserting tube.

[0044] In one embodiment, when the first connecting portion and the second connecting portion are connected to the guiding member, the needle inserting tube punctures the first tissue, and after the first connecting portion and the second connecting portion are separated from the guiding member, the centering structure is recovered.

[0045] In one embodiment, the needle inserting tube passes through the first tissue and the second tissue, that is, the needle inserting tube passes through the secondary septum tissue and the primary septum tissue.

[0046] In one embodiment, the reinforcing unit is shaped in the direction of the guiding member.

[0047] In one embodiment, after the guiding member is recovered, the reinforcing unit and the guiding member clamp the first tissue.

[0048] In one embodiment, after the guiding member is recovered, the first centering member, the second centering member and the guiding member cooperate to clamp the first tissue.

[0049] Compared with the prior art, the advantages of the technical solution of the present application at least include the following:

[0050] 1. It is usually difficult to determine the needle insertion position of the tissue to be closed with existing PFO closure devices, and the needle may be misaligned or fail to reach the target position. In addition, the abutment tube of the internal needle tube often cannot fit the target tissue, and the failure to abut is not conducive to stable needle insertion. The present application solves the above problems. First, the present application provides a centering structure with a guide member, a guide member, a first centering member and a second centering member. After the guide member passes through the first connecting portion and the second connecting portion, the centering structure is in a closed loop state, and the first curved portion and the second curved portion are arched toward both sides. After the centering structure enters the oval foramen channel and is released into a natural state, the centering structure has the effect of opening the oval foramen channel toward both sides. In addition, since the guide member is arranged at the first centering member and the second centering member, the centering structure is in a closed loop state, and the first curved portion and the second curved portion are arched toward both sides. After the centering structure enters the oval foramen channel and is released into a natural state, the centering structure has the effect of opening the oval foramen channel toward both sides. On the weighing surface, the guide piece will be located at the center of the oval foramen channel, thereby ensuring that the needle assembly punctures at the center of the secondary septum, and according to different lesion conditions, the operator can choose to operate the adjustment piece to change the shapes of the first centering piece and the second centering piece to adapt to the shape of the oval foramen, or directly choose to retract the guide piece to release the first centering piece and the second centering piece, and open the oval foramen channel by the swing of the first centering piece and the second centering piece; on the other hand, the guide piece will fit on the proximal surface of the secondary septum, and the centering piece will fit on the distal surface of the secondary septum, and the two will clamp and restrict the secondary septum, so that when the needle assembly is against the secondary septum, the secondary septum tissue will not shake, and the needle assembly can achieve stable needle insertion. Therefore, the design of the present application can simultaneously solve the problems of inability to center and inability to stabilize puncture.

[0051] 2. Different from the prior art, the first connection part, the second connection part and the guide piece of the present application are detachably connected. Only by retracting the guide piece, the first connection part and the second connection part will automatically separate from the guide piece, so that the first curved part and the second curved part swing to both sides, especially the first gathering section and the second gathering section can drive the oval foramen ​​channel from a circle to an "I" shape, so that the first curved part and the second curved part are stuck in the oval foramen ​​channel, and the horizontal distance between the guide piece and the first curved part and the second curved part is small, which is conducive to clamping the secondary partition.

[0052] 3. Different from the prior art, the centering structure of the present application also includes an adjusting piece. Pulling the adjusting piece can realize the shape change of the first arc segment and / or the second arc segment to adapt to oval foramen channels of different shapes, and the first centering piece and the second centering piece are clamped in the oval foramen channel. The three components of the guide piece, the first centering piece and the second centering piece are beneficial to provide a puncture support surface for the needle assembly, ensuring that the needle assembly is used for needle insertion within the needle insertion area.

[0053] 4. Different from the prior art, the suture of the present application will not interfere with the centering structure. After the suture passes through the secundum, the closed-loop centering structure cannot be withdrawn. However, due to the detachable connection relationship between the first connecting portion, the second connecting portion and the leading member, when the leading member is retrieved, the centering structure can be opened into a ring shape, and the centering structure can be successfully retrieved without affecting the position or fixing point of the suture on the lesion.

[0054] The embodiments of the present application can achieve other beneficial technical effects that are not listed one by one, and some of these other technical effects may be described below; and for those skilled in the art, they can be expected and understood after reading the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0055] By referring to the following description in conjunction with the drawings, the above features and advantages of these embodiments and other features and advantages, as well as the manner of achieving them, will become more apparent; and the embodiments of the present application can be better understood. In the drawings:

[0056] Figure 1 Schematic diagram of the overall structure of the closing instrument of the present invention.

[0057] Figure 2 Schematic diagram of the centering structure of the present invention.

[0058] Figure 3 For the working principle of the centering structure of the present invention Figure 1 .

[0059] Figure 4 For the working principle of the centering structure of the present invention Figure 2 .

[0060] Figure 5 Schematic diagram of the operation steps of the present invention Figure 1 .

[0061] Figure 6 Schematic diagram of the operation steps of the present invention Figure 2 .

[0062] Figure 7 Schematic diagram of the operation steps of the present invention Figure 3 .

[0063] Figure 8 Schematic diagram of the operation steps of the present invention Figure 4 .

[0064] Figure 9 Schematic diagram of the operation steps of the present invention Figure 5 .

[0065] Figure 10 Schematic diagram of the operation steps of the present invention Figure 6 .

[0066] Figure 11 The operation steps of the present invention are shown in FIG. Figure 7 .

[0067] Figure 12 The operation steps of the present invention are shown in FIG. Figure 8 .

[0068] Figure 13 The operation steps of the present invention are shown in FIG. Figure 9 .

[0069] Figure 14 Another embodiment of the present invention is shown in FIG. Figure 1 .

[0070] Figure 15 Another embodiment of the present invention is shown in FIG. Figure 2 .

[0071] Figure 16 Another embodiment of the present invention is shown in FIG. Figure 3 .

[0072] Figure 17 Another embodiment of the present invention is shown in FIG. Figure 4 .

[0073] The features indicated by the numbers in the accompanying drawings are as follows:

[0074] 1-first tissue, 2-second tissue, 3-centering structure, 31-pilot, 32-guide, 321-limiting port, 322-connecting hole, 33-first centering member, 331-first bending portion, 3311-first outward expansion section, 3312-first arc section, 3313-first gathering section, 332-first connecting portion, 34-second centering member, 341-second bending portion, 3411-second outward expansion section, 3412-second arc section, 3413-second gathering section, 342-second connecting portion, 35-adjusting member, 36-reinforcement unit, 4-sleeve connector, 5-needle puncture assembly, 51-rest tube, 52-needle puncture tube, 6-first angle, 7-delivery tube, 8-preinstalled tube, 9-control member. DETAILED DESCRIPTION

[0075] In the following description of the drawings and specific embodiments, the details of one or more embodiments of the present application will be described. From these descriptions, drawings and claims, other features, purposes and advantages of the present application can be clearly seen.

[0076] It should be understood that the phrases and terms used herein are for descriptive purposes and should not be considered restrictive. The use of "include", "comprises", or "having" and variations thereof herein is intended to be open-ended to include the items listed thereafter and their equivalents and additional items.

[0077] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the present application.

[0078] In the present application, the terms "proximal" or "proximal side" refer to the end or side closer to the surgical operator, and "distal" or "distal side" refer to the end or side farther from the surgical operator.

[0079] Embodiment 1

[0080] As Figure 1 and Figure 2 shown, when the solution of the present invention is used to close the foramen ovale tissue, a closing instrument with a centering structure 3 is illustrated according to an embodiment of the present application. To close the channel between the first tissue 1 and the second tissue 2, it includes a centering structure 3 and a needle assembly 5. The centering structure 3 includes a pilot member 31, a guiding member 32, a first centering member 33, and a second centering member 34. The proximal ends of the guiding member 32, the first centering member 33, and the second centering member 34 are connected to each other, and the needle assembly 5 is connected to the guiding member 32. Moreover, the pilot member 31 is detachably connected to the distal ends of the first centering member 33 and the second centering member 34.

[0081] In this first embodiment, the first centering member 33 includes a first bending portion 331 and a first connecting portion 332, and the second centering member 34 includes a second bending portion 341 and a second connecting portion 342. Moreover, the first connecting portion 332 and the second connecting portion 342 are detachably connected to the pilot member 31. When the first connecting portion 332 and the second connecting portion 342 are connected to the pilot member 31, the centering structure 3 is in a closed-loop shape, and the first bending portion 331 and the second bending portion 341 arch towards both sides. When the first connecting portion 332 and the second connecting portion 342 are separated from the pilot member 31, the centering structure 3 is in an open-loop shape.

[0082] In this first embodiment, the second connecting portion 342 and the first connecting portion 332 are sequentially sleeved outside the pilot member 31, and the first connecting portion 332 is located at the distal end of the second connecting portion 342.

[0083] In this first embodiment, the length of the first centering member 33 is greater than the length of the second centering member 34.

[0084] In this first embodiment, the distal end of the guiding member 32 is connected to the needle assembly 5, and the plane where the distal end of the guiding member 32 is located intersects with the first bending portion 331 and the second bending portion 341.

[0085] In this first embodiment, a needle insertion area is formed between the first bending portion 331 and the second bending portion 341.

[0086] In the first embodiment, the first tissue 1 is the secondary septum tissue, and the second tissue 2 is the primary septum tissue.

[0087] In the first embodiment, when the leading member 31 is retracted, the first connecting portion 332 and the second connecting portion 342 are disengaged from the leading member 31. The first connecting portion 332 is the free end of the first centering member 33, and the second connecting portion 342 is the free end of the second centering member 34; moreover, the first connecting portion 332 is disengaged from the leading member 31 prior to the second connecting portion 342.

[0088] In the first embodiment, the first bending portion 331 includes a first outward expansion section 3311, a first arc section 3312, and a first closing section 3313 arranged in sequence from the proximal end to the distal end. The second bending portion 341 includes a second outward expansion section 3411, a second arc section 3412, and a second closing section 3413 arranged in sequence from the proximal end to the distal end, as Figure 2 shown.

[0089] In the first embodiment, the plane where the distal end of the guiding member 32 is located intersects the first arc portion and the second arc portion.

[0090] In the first embodiment, when the first connecting portion 332 and the second connecting portion 342 are connected to the leading member 31, the first closing section 3313 and the second closing section 3413 form a first included angle 6. At this time, the first included angle 6 is less than 40°, as Figure 3 shown.

[0091] In the first embodiment, the centering structure 3 includes an adjusting member 35. Limiting connection structures are provided on the first arc section 3312 and the second arc section 3412. The adjusting member 35 is connected to the limiting connection structure, as Figure 2 shown; moreover, by pulling the adjusting member 35, the curvature of the first arc section 3312 and / or the second arc section 3412 can be changed, as Figure 3 and Figure 4 shown.

[0092] In the first embodiment, when the adjusting member 35 is pulled, the first included angle 6 increases.

[0093] In the first embodiment, when the adjusting member 35 is pulled proximally, both the first centering member 33 and the second centering member 34 move proximally. At the same time, the first arc section 3312 and the second arc section 3412 expand towards both sides, causing the oval foramen channel to unfold and flatten, and the guiding member 32 is located in the central region of the proximal end face of the secondary septum, as Figure 4 and Figure 9 shown.

[0094] In the first embodiment, the centering structure 3 further includes a socket part 4. The socket part 4 is located at the proximal end of the centering structure 3. The guiding part 32, the first centering part 33 and the second centering part 34 are all connected to the socket part 4, and the first centering part 33 and the second centering part 34 are arranged oppositely on the circumference.

[0095] In the first embodiment, the guiding part 32 is on the symmetry plane of the first centering part 33 and the second centering part 34.

[0096] In the first embodiment, the closing instrument further includes a delivery tube 7. The delivery tube 7 is connected to the socket part 4, and the delivery tube 7 is sleeved outside the leading part 31.

[0097] In the first embodiment, in the natural state, the guiding part 32 is parallel to the central axis of the delivery tube 7, and the horizontal distance between the guiding part 32 and the first bending part 331 and the second bending part 341 is small.

[0098] In the first embodiment, the closing instrument further includes a preloading tube 8. The centering structure 3, the delivery tube 7 and the needle puncturing assembly 5 are sleeved inside the preloading tube 8.

[0099] In the first embodiment, the centering structure 3 further includes a strengthening unit 36 connected to the first outward expansion section 3311 and the second outward expansion section 3411. The strengthening unit 36 at least partially coincides with the guiding part 32 on the projection plane, as Figure 3 shown.

[0100] In the first embodiment, the strengthening unit 36 is shaped towards the guiding part 32, and the strengthening unit 36 prevents the first outward expansion section 3311 and the second outward expansion section 3411 from being excessively deformed.

[0101] In the first embodiment, after the leading part 31 is recovered, the strengthening unit 36 and the guiding part 32 clamp the first tissue 1.

[0102] In the first embodiment, the guiding part 32 includes a limiting port 321 and a connection hole 322. The needle puncturing assembly 5 includes a abutting tube 51 and a needle puncturing tube 52. The abutting tube 51 is connected to the connection hole 322, and the abutting tube 51 moves inside the limiting port 321, as Figure 1 and Figure 2 shown.

[0103] In the first embodiment, a suture member is provided inside the needle puncturing tube 52.

[0104] In the first embodiment, when the first connecting portion 332, the second connecting portion 342 are connected to the guide member 31, the needle insertion tube 52 punctures the first tissue 1, and after the first connecting portion 332, the second connecting portion 342 are separated from the guide member 31, the centering structure 3 is recovered.

[0105] In the first embodiment, the needle insertion tube 52 passes through the first tissue 1 and the second tissue 2, that is, the needle insertion tube 52 passes through the secondary septal tissue and the primary septal tissue, as Figure 12 shown.

[0106] In the first embodiment, the connection hole 322 of the guiding member 32 is connected to the control member 9. By pulling the control member 9, the guiding member 32 swings towards the right atrium, as Figure 7 shown.

[0107] The exemplary operation process of the closure device in the first embodiment is as follows:

[0108] (1) Establish a PFO access channel, reserve the guide member 31, ensure that the distal end of the guide member 31 is at the position of the left atrium, and then insert the delivery tube 7 into the right atrium through the femoral vein access along the guide member 31, as Figure 5 and Figure 6 shown, and then push it to the position of the patent foramen ovale between the secondary septum and the primary septum near the atrial septum;

[0109] (2) Withdraw the delivery tube 7 to expose the centering structure 3. The centering structure 3 spreads out the foramen ovale channel, and pull the control member 9 to make the guiding member 32 swing towards the right atrium, as Figure 7 and Figure 8 shown;

[0110] (3) Pull the adjusting member 35, and the first arc segment 3312 and the second arc segment 3412 expand towards both sides, so that the foramen ovale channel unfolds and flattens, as Figure 9 shown. Release the control member 9, and the guiding member 32 is located in the central area of the proximal end face of the secondary septum, as Figure 10 shown;

[0111] (4) Operate the abutting tube 51 to move distally, and the abutting tube 51 fits with the secondary septum, as Figure 11 shown;

[0112] (5) Operate the needle insertion tube 52 to pass through the secondary septal tissue and the primary septal tissue, and send out the suture, as Figure 12 shown;

[0113] (6) Recover the guide member 31, the first bending portion 331 and the second bending portion 341 swing towards both sides, the centering structure 3 has no interference with the suture, and recover the centering structure 3;

[0114] (7) operating the suture to close the foramen ovale passage, such as Figure 13 shown.

[0115] Embodiment 2

[0116] The second embodiment is substantially the same as the first embodiment, except that the first curved portion 331 and the second curved portion 341 are aligned by natural shapes, such as Figure 14 and Figure 15 shown.

[0117] In this embodiment, a closing device with a centering structure 3 is introduced, which is used to close the channel between the first tissue 1 and the second tissue 2, including a centering structure 3 and a needle assembly 5, wherein the centering structure 3 includes a leading piece 31, a guide piece 32, a first centering piece 33 and a second centering piece 34, wherein the proximal end of the guide piece 32, the proximal end of the first centering piece 33 and the proximal end of the second centering piece 34 are connected, and the needle assembly 5 is connected to the guide piece 32; and the leading piece 31 is detachably connected to the distal ends of the first centering piece 33 and the second centering piece 34.

[0118] In the second embodiment, the first centering member 33 includes a first bending portion 331 and a first connecting portion 332, and the second centering member 34 includes a second bending portion 341 and a second connecting portion 342. In addition, the first connecting portion 332, the second connecting portion 342 and the pilot member 31 are detachably connected. When the first connecting portion 332, the second connecting portion 342 and the pilot member 31 are connected, the centering structure 3 is in a closed loop shape, such as Figure 14 As shown, the first curved portion 331 and the second curved portion 341 are arched toward both sides. When the first connecting portion 332 and the second connecting portion 342 are separated from the pilot member 31, the centering structure 3 is in an open ring shape. Figure 15 shown.

[0119] In the second embodiment, the guide member 31 is recovered after the centering structure 3 enters the foramen ovale passage.

[0120] In the second embodiment, when the first connecting portion 332 is detached from the guide member 31, the first bending portion 331 swings in a direction away from the guide member 31; when the second connecting portion 342 is detached from the guide member 31, the second bending portion 341 swings in a direction away from the guide member 31, and the swinging direction of the first bending portion 331 is opposite to the swinging direction of the second bending portion 341.

[0121] In the second embodiment, when the first curved portion 331 and the second curved portion 341 swing toward both sides, the oval foramen channel is stretched open and the oval foramen channel stretches into a flat shape.Figure 16 and 17 as shown

[0122] In the second embodiment, the first included angle 6 is an acute angle; and after the first bending portion 331 and the second bending portion 341 are separated from the guide member 31, the first included angle 6 becomes smaller or the first converging section 3313 is parallel to the second converging section 3413.

[0123] In the second embodiment, after the first bending portion 331 and the second bending portion 341 are separated from the guide member 31, the first converging section 3313 and the second converging section 3413 expand the oval foramen channel, and the guiding member 32 and the socket member 4 are automatically located in the central region of the near end surface of the secondary septum.

[0124] In the second embodiment, after the guide member 31 is retracted, the first centering member 33, the second centering member 34 and the guiding member 32 cooperate to clamp the secondary septal tissue.

[0125] In this regard, the relevant structures and concepts of the second embodiment are similar to those of the first embodiment, and thus will not be described again here.

[0126] The foregoing description of several embodiments of the present application has been presented for purposes of illustration. The foregoing description is not intended to be exhaustive nor to limit the present application to the precise configurations, structures, and / or steps disclosed, and obviously many modifications and variations are possible in light of the above teachings. The scope of the invention and all equivalents thereof are intended to be defined by the appended claims.

Claims

1. A PFO closure device with a centering structure, used to close a channel between a first tissue and a second tissue, comprising a centering structure and a needle assembly, characterized in that: The centering structure includes a leading piece, a guide piece, a first centering piece and a second centering piece, the proximal end of the guide piece, the proximal end of the first centering piece and the proximal end of the second centering piece are connected, and the distal end of the guide piece is connected to the needle assembly; and the leading piece is detachably connected to the middle or distal end of the first centering piece and the middle or distal end of the second centering piece; the first centering piece includes a first bending portion and a first connecting portion, and the second centering piece includes a second bending portion and a second connecting portion, and the first connecting portion and the second connecting portion are detachably connected to the leading piece; and when the first connecting portion and the second connecting portion are connected to the leading piece, the centering structure is in a closed loop shape, and the first bending portion and the second bending portion are arched toward both sides, and when the first connecting portion and the second connecting portion are separated from the leading piece, the centering structure is in an open loop shape; and the first centering piece and the second centering piece are arranged opposite to each other on the circumference; and the guide piece is on the symmetric plane of the first centering piece and the second centering piece.

2. The PFO closure device with a centering structure according to claim 1, characterized in that: The distal end of the guide is connected to the needle insertion assembly, and the plane where the distal end of the guide is located intersects with the planes where the first curved portion and the second curved portion are located; and a needle insertion area is formed between the first curved portion and the second curved portion.

3. The PFO closure device with a centering structure according to claim 1, characterized in that: The guide piece is withdrawn, and the first connection part and the second connection part are separated from the guide piece, wherein the first connection part is a free end part of the first centering piece; and the first connection part is separated from the guide piece before the second connection part.

4. The PFO closure device with a centering structure according to claim 1, characterized in that: The distal end and the proximal end of the first connecting part and the distal end and the proximal end of the second connecting part are both provided with guiding structures, and the guiding structures facilitate the delivery and withdrawal of the centering structure in a preset channel and / or human tissue.

5. The PFO closure device with a centering structure according to claim 1, characterized in that: When the first connecting portion is detached from the guide member, the first curved portion swings in a direction away from the guide member; when the second connecting portion is detached from the guide member, the second curved portion swings in a direction away from the guide member, and the swinging direction of the first curved portion is opposite to the swinging direction of the second curved portion.

6. The PFO closure device with a centering structure according to claim 1, characterized in that: The first curved portion includes a first outward expansion section, a first arc section and a first convergence section which are arranged in sequence from the proximal end to the distal end, and the second curved portion includes a second outward expansion section, a second arc section and a second convergence section which are arranged in sequence from the proximal end to the distal end; when the first connecting portion and the second connecting portion are connected to the guide piece, the first convergence section and the second convergence section form a first angle.

7. The PFO closure device with a centering structure according to claim 6, characterized in that: The first angle is an acute angle; and after the first curved portion and the second curved portion are separated from the guide member, the first angle becomes smaller or the first gathering section is parallel to the second gathering section.

8. The PFO closure device with a centering structure according to claim 6, characterized in that: The centering structure includes an adjusting piece, and a limiting connection structure is provided on the first arc segment and / or the second arc segment, and the adjusting piece is connected to the limiting connection structure; and pulling the adjusting piece can change the curvature of the first arc segment and / or the second arc segment; and pulling the adjusting piece increases the first angle.

9. The PFO closure device with a centering structure according to claim 1, characterized in that: The centering structure further includes a sleeve member, which is located at the proximal end of the centering structure. The guide member, the first centering member and the second centering member are all fixedly connected to the sleeve member.

10. The PFO closure device with a centering structure according to claim 2, characterized in that: The guide member includes a limiting opening and a connecting hole, the needle puncture assembly includes a supporting tube and a needle puncture tube, the supporting tube is connected to the connecting hole, and the supporting tube moves in the limiting opening; and a suture piece is arranged in the needle puncture tube.

11. The PFO closure device with a centering structure according to claim 10, characterized in that: The movement trajectory of the abutting tube forms a first plane, and the first plane is perpendicular to the plane where the first centering piece and the second centering piece are located.

12. The PFO closure device with a centering structure according to claim 10, characterized in that: When the first connection part and the second connection part are connected to the guide piece, the puncture tube punctures the first tissue, and the first connection part and the second connection part are separated from the guide piece and the centering structure is recovered.

13. The PFO closure device with a centering structure according to claim 6, characterized in that: The centering structure further includes a reinforcing unit connected to the first outward expansion section and the second outward expansion section, and the reinforcing unit and the guide member at least partially overlap on the projection surface.

14. The PFO closure device with a centering structure according to claim 13, characterized in that: The reinforcing unit is shaped toward the guide member; and after the guide member is recovered, the reinforcing unit and the guide member clamp the first tissue.

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