PFO closing instrument with centering structure

Abstract

The invention relates to the field of medical instruments, in particular to a PFO closing instrument with a centering structure, the PFO closing instrument is used for closing a channel between first tissue and second tissue, the PFO closing instrument comprises the centering structure and a needle inserting assembly, and the centering structure comprises a guiding part, a guiding part, a first centering part and a second centering part; the near end of the guiding piece, the near end of the first centering piece and the near end of the second centering piece are connected, and the far end of the guiding piece is connected with the needle inserting assembly; and the pilot piece is detachably connected with the middle part or the far end of the first centering piece and the middle part or the far end of the second centering piece.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to a PFO closure device with a centering structure. Background Art

[0002] The foramen ovale is a fissure located at the junction of the primary and secondary septa of the atrial septum. It is a blood supply channel for the heart formed during embryonic development. After birth, the blood supply channel will change and the foramen ovale will close naturally. If the foramen ovale has not closed after the age of 3, it is called a patent foramen ovale. About 25% of the population has a patent foramen ovale. In recent years, with the continuous deepening of research on patent foramen ovale, various clinical syndromes caused by patent foramen ovale have received more and more clinical attention, including cryptogenic stroke, transient ischemic attack, migraine, recumbent breathing-upright hypoxemia, sleep apnea syndrome, myocardial infarction with normal coronary arteries, and neurological decompression sickness. Cryptogenic stroke and migraine, in particular, not only cause great physical pain and mental torture to patients, but also bring heavy burdens to families and society.

[0003] Common treatments for patent foramen ovale include implanting a double disc structure or suturing the patent channel. However, since a large piece of indecomposable device will remain in the heart after the occlusion disc is implanted, it is not conducive to the patient's recovery and will affect other surgical treatments. Therefore, suturing is often recommended clinically.

[0004] Patent 202210946389.3 discloses a repair system that facilitates puncture, which includes at least a double puncture structure, a capture device and a repair component, wherein the repair component is at least partially sleeved in the double puncture structure, and the double puncture structure can puncture two tissues with gaps back and forth during the repair process, and the capture device is arranged on the starting point side of the first puncture of the double puncture structure during the repair process and presses against the tissue, providing support for the second puncture of the double puncture structure. The double puncture structure delivers the repair component to the target position during the puncture process, and the repair component connects the two punctured tissues to reduce or eliminate the gap; the design defects of this scheme are: first, when puncturing the secondary septum, it cannot be guaranteed that the puncture point is located in the central area of ​​the secondary septum, thereby affecting the post-suturing sealing effect of the single suture; secondly, the puncture tube has no guide structure, which will cause instability or shaking or displacement during puncture.

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

[0006] This application is proposed in view of the above and other more concepts.

[0007] One of the purposes of the present application is to overcome the deficiencies of the prior art. In view of the problems in the prior art that closing devices cannot simultaneously ensure puncture in the central area of ​​the tissue and the needle is unstable and displaced during puncture, a closing device with a centering structure is provided.

[0008] The object of the present invention is achieved through the following solutions: A PFO closure device with a centering structure is used to close a channel between a first tissue and a second tissue, comprising a guide member and a needle assembly, wherein the centering structure comprises a guide member, a guide, a first centering member and a second centering member, wherein the proximal end of the guide member, the proximal end of the first centering member and the proximal end of the second centering member are connected, and the distal end of the guide member is connected to the needle assembly; and the guide member is detachably connected to the middle or distal end of the first centering member and the middle or distal end of the second centering member.

[0009] The purpose of the present invention can be further achieved by the following technical solutions: In one embodiment, the first centering member includes a first bent portion and a first connecting portion, the second centering member includes a second bent portion and a second connecting portion, and the first connecting portion, the second connecting portion and the guide member are detachably connected; and when the first connecting portion, the second connecting portion are connected to the guide member, the centering structure is in a closed loop shape, and the first bent portion and the second bent portion are arched toward both sides; when the first connecting portion, the second connecting portion are separated from the guide member, the centering structure is in an open loop shape.

[0010] In one embodiment, the second connection portion and the first connection portion are sequentially sleeved outside the guide member, and the first connection portion is located at the distal end of the second connection portion.

[0011] In one embodiment, the length of the first centering member is greater than the length of the second centering member.

[0012] In one embodiment, the distal end of the guide is connected to the needle assembly, and the plane where the distal end of the guide is located intersects with the first curved portion and the second curved portion.

[0013] In another embodiment, the distal end of the guide is connected to the needle assembly, and the plane where the distal end of the guide is located is parallel to the first curved portion and the second curved portion.

[0014] In one embodiment, a needle insertion area is formed between the first curved portion and the second curved portion.

[0015] 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.

[0016] 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.

[0017] In one embodiment, the guide structure is cylindrical or channel-shaped.

[0018] In one embodiment, the second connecting portion is a free end portion of the second centering member.

[0019] 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.

[0020] 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.

[0021] 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.

[0022] 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.

[0023] In one embodiment, when the first connecting portion and the second connecting portion are connected to the guide member, the first gathering section and the second gathering section form a first angle, and at this time, the first angle is less than 40°.

[0024] 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.

[0025] In another embodiment, the first angle is a right angle.

[0026] In another embodiment, the first angle is an obtuse angle.

[0027] 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.

[0028] 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.

[0029] 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.

[0030] In one embodiment, when the adjusting member is pulled, the first angle increases.

[0031] 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.

[0032] In one embodiment, the guide member is on a symmetric plane of both the first centering member and the second centering member.

[0033] 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.

[0034] In one embodiment, in a natural state, the guide member is parallel to the center line of the delivery tube.

[0035] In one embodiment, the horizontal distance between the guide member and the first curved portion and the second curved portion is small.

[0036] 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.

[0037] In one embodiment, 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 plane.

[0038] In one embodiment, the reinforcing unit prevents the first expansion section and the second expansion section from being excessively deformed.

[0039] In one embodiment, the guide member includes a limiting opening and a connecting hole, and 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.

[0040] 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.

[0041] In one embodiment, a suture piece is disposed inside the needle puncture tube.

[0042] In one embodiment, when the first connection part and the second connection part are connected to the guide member, the puncture tube punctures the first tissue, and the first connection part and the second connection part are separated from the guide member and the centering structure is recovered.

[0043] In one embodiment, the puncture tube passes through the first tissue and the second tissue, that is, the puncture tube passes through the secondary septal tissue and the primary septal tissue.

[0044] In one embodiment, the reinforcing unit is shaped in the direction of the guide member.

[0045] In one embodiment, after the leading member is recovered, the reinforcing unit and the guiding member clamp the first tissue.

[0046] In one embodiment, after the leading member is retracted, the first centering member, the second centering member cooperate with the guiding member to clamp the first tissue.

[0047] Compared with the prior art, the advantages of the technical solution of the present application include at least the following: 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.

[0048] 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.

[0049] 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.

[0050] 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 secondary septum, the closed-loop centering structure cannot be withdrawn. However, due to the detachable connection between the first connecting part, the second connecting part and the guide piece, the guide piece can be recovered and the centering structure can be open-loop. The centering structure can be successfully recovered without affecting the position or fixing point of the suture on the lesion.

[0051] The embodiments of the present application can achieve other advantageous technical effects that are not listed one by one, and these other technical effects may be partially described below; and are predictable and understandable to those skilled in the art after reading this application. BRIEF DESCRIPTION OF THE DRAWINGS

[0052] The above features and advantages of these embodiments and other features and advantages and the manner in which they are achieved will become more apparent and the embodiments of the present application can be better understood by referring to the following description together with the accompanying drawings, in which:

[0053] Figure 1 A schematic diagram of the overall structure of the closure device of the present invention.

[0054] Figure 2 Schematic diagram of the centering structure of the present invention.

[0055] Figure 3 The working principle of the centering structure of the present invention is Figure 1 .

[0056] Figure 4 The working principle of the centering structure of the present invention is Figure 2 .

[0057] Figure 5 The operation steps of the present invention are shown in FIG. Figure 1 .

[0058] Figure 6 The operation steps of the present invention are shown in FIG. Figure 2 .

[0059] Figure 7 The operation steps of the present invention are shown in FIG. Figure 3 .

[0060] Figure 8 The operation steps of the present invention are shown in FIG. Figure 4 .

[0061] Fig. 9 The operation steps of the present invention are shown in FIG. Figure 5 .

[0062] Fig.10 The operation steps of the present invention are shown in FIG. Figure 6 .

[0063] Fig.11 The operation steps of the present invention are shown in FIG. Figure 7 .

[0064] Fig.12 The operation steps of the present invention are shown in FIG. Figure 8 .

[0065] Fig.13 The operation steps of the present invention are shown in FIG. Figure 9 .

[0066] Fig.14 Another embodiment of the present invention is shown in FIG. Figure 1 .

[0067] Fig.15 Another embodiment of the present invention is shown in FIG. Figure 2 .

[0068] Fig.16 Another embodiment of the present invention is shown in FIG. Figure 3 .

[0069] Fig.17 Another embodiment of the present invention is shown in FIG. Figure 4 .

[0070] The features indicated by the numbers in the accompanying drawings are as follows: 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

[0071] 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.

[0072] 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.

[0073] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the present application.

[0074] In the present application, the term “proximal end” or “proximal side” refers to an end or a side closer to a surgical operator, and the term “distal end” or “distal side” refers to an end or a side farther from a surgical operator.

[0075] Embodiment 1

[0076] like Figure 1 and Figure 2 As shown, when the scheme of the present invention is used to close the foramen ovale tissue, a closing device with a centering structure 3 according to an embodiment of the present application is illustrated, which is used to close the channel between the first tissue 1 and the second tissue 2, and includes a centering structure 3 and a needle assembly 5. The centering structure 3 includes a leading piece 31, a guide piece 32, a first centering piece 33 and a second centering piece 34. 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.

[0077] In the first embodiment, the first centering member 33 includes a first bent portion 331 and a first connecting portion 332, and the second centering member 34 includes a second bent portion 341 and a second connecting portion 342, and the first connecting portion 332, the second connecting portion 342 are detachably connected to the guide member 31. When the first connecting portion 332, the second connecting portion 342 are connected to the guide member 31, the centering structure 3 is in a closed loop shape, and the first bent portion 331 and the second bent portion 341 are arched toward both sides. When the first connecting portion 332, the second connecting portion 342 are separated from the guide member 31, the centering structure 3 is in an open loop shape.

[0078] In the first embodiment, the second connection portion 342 and the first connection portion 332 are sequentially sleeved outside the guide member 31 , and the first connection portion 332 is located at the distal end of the second connection portion 342 .

[0079] In the first embodiment, the length of the first centering member 33 is greater than the length of the second centering member 34 .

[0080] In the first embodiment, the distal end of the guide member 32 is connected to the needle assembly 5 , and the plane where the distal end of the guide member 32 is located intersects with the first curved portion 331 and the second curved portion 341 .

[0081] In the first embodiment, a needle insertion area is formed between the first curved portion 331 and the second curved portion 341 .

[0082] In the first embodiment, the first tissue 1 is a secondary septal tissue, and the second tissue 2 is a primary septal tissue.

[0083] In the first embodiment, the guide member 31 is withdrawn, and the first connection portion 332 and the second connection portion 342 are detached from the guide member 31. The first connection portion 332 is the free end portion of the first centering member 33, and the second connection portion 342 is the free end portion of the second centering member 34. Furthermore, the first connection portion 332 is detached from the guide member 31 before the second connection portion 342.

[0084] In the first embodiment, the first curved portion 331 includes a first outward expansion section 3311, a first arc section 3312 and a first convergence section 3313 arranged in sequence from the proximal end to the distal end, and the second curved portion 341 includes a second outward expansion section 3411, a second arc section 3412 and a second convergence section 3413 arranged in sequence from the proximal end to the distal end. Figure 2 shown.

[0085] In the first embodiment, the plane where the distal end of the guide member 32 is located intersects with the first arc portion and the second arc portion.

[0086] In the first embodiment, when the first connection portion 332 and the second connection portion 342 are connected to the guide member 31, the first retracted section 3313 and the second retracted section 3413 form a first angle 6, and the first angle 6 is less than 40°. Figure 3 shown.

[0087] In the first embodiment, the centering structure 3 includes an adjusting member 35, and a limiting connection structure is provided on the first arc segment 3312 and the second arc segment 3412, and the adjusting member 35 is connected to the limiting connection structure. Figure 2 and, pulling the adjustment member 35 can change the curvature of the first arc segment 3312 and / or the second arc segment 3412, such as Figure 3 and Figure 4 shown.

[0088] In the first embodiment, the adjusting member 35 is pulled, and the first angle 6 increases.

[0089] In the first embodiment, when the adjusting member 35 is pulled toward the proximal end, the first centering member 33 and the second centering member 34 will move toward the proximal end, and at the same time, the first arc segment 3312 and the second arc segment 3412 are stretched toward both sides, so that the oval foramen channel is unfolded and flattened, and the guide member 32 is located in the central area of ​​the proximal surface of the secondary septum, such as Figure 4 and Fig. 9 shown.

[0090] In the first embodiment, the centering structure 3 also includes a socket 4, which is located at the proximal end of the centering structure 3, and the guide member 32, the first centering member 33 and the second centering member 34 are all connected to the socket 4, and the first centering member 33 and the second centering member 34 are arranged opposite to each other on the circumference.

[0091] In the first embodiment, the guide member 32 is on a symmetrical plane between the first centering member 33 and the second centering member 34 .

[0092] In the first embodiment, the closure device further comprises a delivery tube 7 , which is connected to the sleeve member 4 , and is sleeved outside the guide member 31 .

[0093] In the first embodiment, in a natural state, the guide member 32 is parallel to the center line of the delivery pipe 7 , and the horizontal spacing between the guide member 32 and the first curved portion 331 and the second curved portion 341 is small.

[0094] In the first embodiment, the closure device further comprises a pre-installed tube 8 , and the centering structure 3 , the delivery tube 7 and the needle assembly 5 are sleeved in the pre-installed tube 8 .

[0095] In the first embodiment, the centering structure 3 further includes a reinforcing unit 36 ​​connected to the first expansion section 3311 and the second expansion section 3411, and the reinforcing unit 36 ​​and the guide member 32 at least partially overlap on the projection surface. Figure 3 shown.

[0096] In the first embodiment, the reinforcing unit 36 ​​is shaped toward the guiding member 32 , and the reinforcing unit 36 ​​prevents the first outward expansion section 3311 and the second outward expansion section 3411 from excessive deformation.

[0097] In the first embodiment, after the leading member 31 is recovered, the reinforcing unit 36 ​​and the guiding member 32 clamp the first tissue 1 .

[0098] In the first embodiment, the guide member 32 includes a limit opening 321 and a connecting hole 322, and the needle assembly 5 includes a support tube 51 and a needle tube 52. The support tube 51 is connected to the connecting hole 322, and the support tube 51 moves in the limit opening 321. Figure 1 and Figure 2 shown.

[0099] In the first embodiment, the puncture tube 52 is provided with a suture piece.

[0100] In the first embodiment, when the first connection part 332 and the second connection part 342 are connected to the guide member 31 , the puncture tube 52 punctures the first tissue 1 , and the first connection part 332 and the second connection part 342 are separated from the guide member 31 and the centering structure 3 is recovered.

[0101] In the first embodiment, the needle tube 52 passes through the first tissue 1 and the second tissue 2, that is, the needle tube 52 passes through the secondary septal tissue and the primary septal tissue. Fig.12 shown.

[0102] In the first embodiment, the connecting hole 322 of the guide member 32 is connected to the control member 9, and the control member 9 is pulled, and the guide member 32 swings toward the right atrium. Figure 7 shown.

[0103] The exemplary operation process of inserting the closure device of the first embodiment is as follows: (1) Establish a PFO access channel, reserve the guide piece 31, ensure that the distal end of the guide piece 31 is in the left atrium, and then pass the delivery tube 7 along the guide piece 31 through the femoral vein into the right atrium, as shown in FIG. Figure 5 and Figure 6 As shown, it is then pushed to the patent foramen ovale position between the secondary septum and the primary septum close to the atrial septum; (2) withdraw the delivery tube 7 to expose the centering structure 3, the centering structure 3 spreads the foramen ovale channel, and pulls the control member 9 to make the guide member 32 swing toward the right atrium, as shown in FIG. Figure 7 and Figure 8 As shown; (3) Pull the adjusting member 35, the first arc segment 3312 and the second arc segment 3412 are stretched toward both sides, so that the foramen ovale is expanded and flattened. Fig. 9 As shown, the control member 9 is released, and the guide member 32 is located in the central area of ​​the proximal end surface of the secondary septum, as shown in FIG. Fig.10 As shown; (4) The abutting tube 51 is operated to move toward the distal end, and the abutting tube 51 is fitted with the septum secundum. Fig.11 As shown; (5) Operate the puncture tube 52 to pass through the secondary septum and the primary septum tissue and deliver the suture piece, such as Fig.12 As shown; (6) The guide member 31 is recovered, the first curved portion 331 and the second curved portion 341 are swung toward both sides, the centering structure 3 does not interfere with the suturing member, and the centering structure 3 is recovered; (7) operating the suture to close the foramen ovale passage, such as Fig.13 shown.

[0104] Embodiment 2

[0105] 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 Fig.14 and Fig.15 shown.

[0106] 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.

[0107] 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 Fig.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. Fig.15 shown.

[0108] In the second embodiment, the guide member 31 is recovered after the centering structure 3 enters the foramen ovale passage.

[0109] 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.

[0110] 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. Fig.16 and 17 shown.

[0111] In the second embodiment, the first angle 6 is an acute angle; and after the first curved portion 331 and the second curved portion 341 are separated from the guide member 31 , the first angle 6 becomes smaller or the first retracted section 3313 is parallel to the second retracted section 3413 .

[0112] In the second embodiment, after the first curved portion 331 and the second curved portion 341 are separated from the guide member 31, the first retracted section 3313 and the second retracted section 3413 open the oval foramen channel, and the guide member 32 and the sleeve member 4 are automatically located in the central area of ​​the proximal surface of the secondary septum.

[0113] In the second embodiment, after the leading member 31 is recovered, the first centering member 33 and the second centering member 34 cooperate with the guiding member 32 to clamp the secondary septal tissue.

[0114] In this regard, the relevant structure and concept of the second embodiment are similar to those of the first embodiment, and thus will not be described again here.

[0115] The foregoing description of several embodiments of the present application is presented for illustrative purposes. The foregoing description is not intended to be exhaustive, nor is it intended to limit the present application to the precise configurations, constructions and / or steps disclosed, and it is apparent that many modifications and variations may be made in light of the teachings above. The scope of the present invention and all equivalents 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.

2. The PFO closure device with a centering structure according to claim 1, characterized in that: The first centering piece includes a first bent portion and a first connecting portion, the second centering piece includes a second bent portion and a second connecting portion, the first connecting portion, the second connecting portion and the guide piece are detachably connected; and when the first connecting portion, the second connecting portion are connected to the guide piece, the centering structure is in a closed loop shape, the first bent portion and the second bent portion are arched toward both sides, and when the first connecting portion, the second connecting portion are separated from the guide piece, the centering structure is in an open loop shape.

3. The PFO closure device with a centering structure according to claim 2, 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.

4. The PFO closure device with a centering structure according to claim 2, 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.

5. The PFO closure device with a centering structure according to claim 2, 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.

6. The PFO closure device with a centering structure according to claim 2, 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.

7. The PFO closure device with a centering structure according to claim 2, 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.

8. The PFO closure device with a centering structure according to claim 7, 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.

9. The PFO closure device with a centering structure according to claim 7, 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.

10. The PFO closure device with a centering structure according to claim 1, characterized in that: The centering structure also 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, and the first centering member and the second centering member are arranged opposite to each other on the circumference; and the guide member is on the symmetric plane of the first centering member and the second centering member.

11. 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.

12. The PFO closure device with a centering structure according to claim 11, 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.

13. The PFO closure device with a centering structure according to claim 11, 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.

14. The PFO closure device with a centering structure according to claim 7, 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.

15. The PFO closure device with a centering structure according to claim 14, 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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