Apical closure device

Abstract

The apical closure device of the present invention comprises a sheath tube, a puncture assembly and a suturing assembly. The sheath tube has a sheath tube cavity. The puncture assembly has a push channel. The push channel comprises a push inlet and a plurality of branch outlets communicating with the push inlet. The branch outlets have a push direction line for pushing outward along the central axis thereof, and the push inlet has a push direction line for pushing inward along the central axis thereof. There are a plurality of suturing assemblies, which can be slidably accommodated in the push channel. The suturing assembly comprises an outer suture and an inner suture. One end of the outer suture moves to the outer side of the heart through the branch outlet and is anchored, and the other end of the outer suture extends to the outer side of the heart through the push inlet. One end of the inner suture moves to the inner side of the heart through the branch outlet and is anchored, and the other end of the inner suture moves to the outer side of the heart through the branch outlet. The ends of each outer suture and each inner suture exposed to the outer side of the heart form a knot together outside the apical hole for locking.

Description

Technical Field

[0001] The invention belongs to the technical field of interventional medical equipment, and in particular relates to an apex closure device. Background Art

[0002] At present, with the gradual aging of the population in my country, more and more people suffer from heart valve diseases, especially mitral valve regurgitation, which seriously affects the quality of life and life expectancy of patients. With the advancement of technology, artificial heart valve replacement can be used clinically to replace the diseased valve to treat mitral valve regurgitation.

[0003] The most popular technology at present is to use transapical catheter to implant artificial valves. An opening needs to be made at the apex of the heart to allow the catheter to enter the heart chamber. After the artificial valve is implanted, the apex is closed by suturing the purse string method. Due to the small operating space and high difficulty, it is very dependent on the operator's experience. If the purse string is not tied tightly, there is a risk of apical bleeding. Summary of the invention

[0004] The purpose of the present invention is to at least solve the problem that the apical hole is not tightly closed after suturing, and this purpose is achieved by the following methods:

[0005] The present invention provides an apical closure device for closing the apical hole of the heart, comprising:

[0006] A sheath having a sheath lumen;

[0007] The puncture assembly has a push channel, the push channel includes a push inlet and a plurality of branch outlets communicated with the push inlet, the branch outlet has a push direction line pushed outward along its central axis, and the push inlet has a push direction line pushed inward along its central axis, when the puncture assembly slides relative to the sheath tube until the plurality of branch outlets are accommodated in the sheath tube cavity, the range of the accommodation angle θ1 formed by the push direction lines of the plurality of branch outlets and the push direction lines is [0°, 15°]; when the puncture assembly slides relative to the sheath tube so that the puncture assembly is in a natural state, the range of the rotation angle θ2 between the push direction lines of the plurality of branch outlets and the push direction lines is (90°, 180°];

[0008] A suturing assembly, wherein the number of the suturing assemblies is multiple, the number of the suturing assemblies is the same as the number of the branch outlets, and the suturing assemblies are arranged one-to-one with the branch outlets, the suturing assemblies can be slidably accommodated in the pushing channel, the suturing assembly includes an outer suture and an inner suture, one end of the outer suture moves to the outside of the heart through the branch outlet and is anchored, and the other end of the outer suture extends to the outside of the heart through the pushing inlet, one end of the inner suture moves to the inside of the heart through the branch outlet and is anchored, and the other end of the inner suture moves to the outside of the heart through the branch outlet, and the ends of each outer suture and each inner suture exposed to the outside of the heart form a knot together outside the apical hole for locking. According to the apical closure device of the present invention, by arranging a suturing assembly in the puncture assembly, when the apical hole needs to be sutured, the sheath tube is inserted into the apical hole, and then the branch tube of the puncture assembly is pushed from the inside of the sheath tube to the outside of the sheath tube, so that the puncture assembly is in a natural state and the branch tube is arranged from the inside of the heart to the outside, the sheath tube and the puncture assembly are moved toward the proximal end, so that the puncture assembly penetrates from the inside of the heart to the outside of the heart, and at the same time, one end of the outer suture moves to the outside of the heart through the branch outlet and is anchored, and then the sheath tube is moved toward the distal end. The branch tube is retracted to the inner side of the heart, and at the same time, one end of the inner suture moves to the inner side of the heart through the branch outlet and is anchored, so that the inner and outer sides of the heart are fixed at the same time by the outer suture and the inner suture. Since the other end of the outer suture extends to the outside of the heart through the push inlet, and the other end of the inner suture moves to the outside of the heart through the branch outlet, the ends of each outer suture and each inner suture exposed to the outside of the heart are formed into a knot outside the apical hole for locking, thereby achieving the closure of the apical hole, reducing the risk of bleeding, and facilitating the operation and saving operation time.

[0009] When the above-mentioned apical closure device is used, the suturing assembly is arranged in the puncture assembly, and the suturing assembly and the puncture assembly are both received in the sheath tube, the sheath tube carries the puncture assembly and the suturing assembly, one end of the sheath tube is inserted into the heart through the apical hole, the puncture assembly is operated to be unfolded in the heart, and then the puncture assembly is operated to puncture the heart and make at least a part of the branch outlet located outside the heart, one end of the outer suture is transported to the outside of the heart from the branch outlet and anchored with the myocardium, the other end of the outer suture is extended from the puncture assembly and the apical hole to the outside of the heart, one end of the inner suture is transported to the outside of the heart along the branch outlet and retained on the outside of the heart; then the puncture assembly is operated to make the branch outlet return to the heart, and then the inner suture is operated to make the other end move from the branch outlet to the heart, and the inner suture is anchored with the myocardium inside the heart, and then the outer suture and the inner suture exposed to the outside of the heart are knotted to close the apical hole. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Various other advantages and benefits will become apparent to those of ordinary skill in the art by reading the detailed description of the preferred embodiments below. The accompanying drawings are only for the purpose of illustrating the preferred embodiments and are not to be considered as limiting the present invention. Moreover, the same reference numerals are used throughout the accompanying drawings to represent the same components. Among them:

[0011] Figure 1 It is a schematic structural diagram of the apical closure device after the branch tubes are deployed in the first embodiment of the present invention;

[0012] Figure 2 for Figure 1 A schematic diagram of the structure of the puncture assembly when the middle branch tube is received in the sheath lumen;

[0013] Figure 3 for Figure 1 A schematic diagram of the structure of the puncture assembly in a natural state;

[0014] Figure 4 for Figure 1 The structure of the sutured component is intended;

[0015] Figure 5 for Figure 4 Schematic diagram of the structure of the mediolateral anchor;

[0016] Figure 6 for Figure 1 A schematic diagram of the relative position structure of the puncture component and the suturing component when the puncture component is in a natural state;

[0017] Figure 7 for Figure 1 A schematic diagram of the relative position structure of the puncture assembly and the suturing assembly when the middle branch tube is received in the sheath tube;

[0018] Figure 8 for Figure 1 Schematic diagram of the structure of the central apical closure device when inserted into the apical hole;

[0019] Fig. 9 for Figure 8 A schematic diagram of the relative position structure of the apex closure device and the apex of the heart after the middle branch tube is deployed;

[0020] Fig.10 for Figure 8 Schematic diagram of the structure when the middle branch tube is inserted into the myocardium;

[0021] Fig.11 for Figure 8 Schematic diagram of the structure when the middle and lateral anchors are anchored to the myocardium;

[0022] Fig.12 for Figure 8 Schematic diagram of the structure when the medial anchor is anchored to the myocardium;

[0023] Fig.13 for Figure 8 A schematic diagram of the structure of the outer side of the apex after the apical hole is sutured by the apical closure device;

[0024] Fig.14 A schematic structural diagram of the puncture assembly after the branch tubes are deployed in the second embodiment of the present invention;

[0025] Fig.15 To include Fig.14 A schematic diagram of the structure of the outer side of the apex after the apex hole is sutured by the apex closure device of the puncture assembly;

[0026] Fig.16 A schematic structural diagram of a gasket in a third embodiment of the present invention;

[0027] Fig.17 for Fig.16 AA section structure diagram of the middle gasket;

[0028] Fig.18 for Fig.16 Schematic diagram of the structure before the middle gasket is inserted into the apical hole;

[0029] Fig.19 for Fig.16 Schematic diagram of the structure after the middle gasket is inserted into the apical hole.

[0030] The symbols in the accompanying drawings are as follows:

[0031] 100: Apical closure device;

[0032] 10: sheath;

[0033] 20: puncture assembly, 21: main operation tube, 211: push inlet, 22: connection structure, 23: branch tube, 231: branch outlet;

[0034] 30: Push tube;

[0035] 40: suture assembly, 41: inner anchor, 411: inner connecting tube, 412: inner fixing claw, 413: inner flow-blocking membrane, 42: outer anchor, 421: outer connecting tube, 422: outer fixing claw, 423: outer flow-blocking membrane;

[0036] 51: lateral suture, 52: medial suture, 53: knotting point;

[0037] 60: gasket, 61: connecting hole, 62: connecting hole;

[0038] 200: Heart, 210: Myocardium, 220: Apical foramen. DETAILED DESCRIPTION

[0039] The exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present invention are shown in the accompanying drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided in order to enable a more thorough understanding of the present invention and to fully convey the scope of the present invention to those skilled in the art.

[0040] It should be understood that the terms used herein are only for the purpose of describing specific example embodiments and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "one", "an" and "said" as used herein may also be meant to include plural forms. The terms "include", "comprise", "contain", and "have" are inclusive, and therefore specify the existence of stated features, steps, operations, elements and / or parts, but do not exclude the existence or addition of one or more other features, steps, operations, elements, parts, and / or combinations thereof. The method steps, processes, and operations described herein are not interpreted as necessarily requiring them to be performed in the specific order described or illustrated, unless the execution order is clearly indicated. It should also be understood that additional or alternative steps may be used.

[0041] Although the terms first, second, third, etc. can be used in the text to describe multiple elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can only be used to distinguish an element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates, terms such as "first", "second" and other numerical terms do not imply order or sequence when used in the text. Therefore, the first element, component, region, layer or section discussed below can be referred to as the second element, component, region, layer or section without departing from the teaching of the example embodiments.

[0042] For ease of description, spatial relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figure, such as "inside", "outside", "inner side", "outer side", "below", "below", "above", "above", etc. Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure. For example, if the device in the figure is turned over, then the elements described as "below other elements or features" or "below other elements or features" will subsequently be oriented as "above other elements or features" or "above other elements or features". Therefore, the example term "below..." can include both upper and lower orientations. The device can be oriented otherwise (rotated 90 degrees or in other directions) and the spatial relative descriptors used in the text are interpreted accordingly.

[0043] In order to more clearly describe the structure of the suturing device, the terms "proximal end" and "distal end" are defined here as commonly used terms in the field of interventional medicine. Specifically, the "distal end" refers to the end away from the operator during the surgical operation, the "proximal end" refers to the end close to the operator during the surgical operation, the "axial" refers to its length direction, and the "radial" refers to the direction perpendicular to the "axial" direction.

[0044] Combination Figures 1 to 3 As shown, the apical closure device 100 of this embodiment includes a sheath tube 10, a puncture assembly 20, a push tube 30 and a suturing assembly 40. The sheath tube 10 has a sheath tube cavity, and the puncture assembly 20 is disposed in the sheath tube 10 and can move along the axial direction of the sheath tube cavity.

[0045] The puncture assembly 20 includes a main operating tube 21 and multiple branch tubes 23. Each branch tube 23 is connected to the main operating tube 21 through a connecting structure 22. The connecting structure 22 forms a connecting channel. The branch tube 23 forms a branch channel. Each branch channel is connected to the connecting channel one by one. The outlet of the branch tube 23 at its free end is a branch outlet 231. The main operating tube 21 forms a main channel. The inlet of the main operating tube 21 at its free end is a push inlet 211. Each branch channel is connected to the main channel through a connecting channel connected thereto. Each branch channel, each connecting channel and the main channel are connected and together form a push channel.

[0046] The push inlet 211 has an inward pushing direction line L1 along its central axis, and the branch outlet 231 has an outward pushing direction line L2 along its central axis. When the puncture assembly 20 slides relative to the sheath tube 10 until the multiple branch outlets 231 are accommodated in the sheath tube cavity, the range of the accommodation angle θ1 formed by the push direction lines L2 of the multiple branch outlets 231 and the push direction line L1 is [0°, 15°]; when the puncture assembly 20 slides relative to the sheath tube 10 so that the puncture assembly 20 is in a natural state, the range of the rotation angle θ2 between the push direction lines L3 of the multiple branch outlets 231 and the push direction line L1 is (90°, 180°).

[0047] Specifically, when the connecting structure 22 is accommodated in the sheath tube 10, the range of the accommodation angle θ1 is [0°, 15°]; when the puncture assembly 20 is in a natural state, the connecting structure 22 is curved, and the range of the rotation angle θ2 is (90°, 180°]. Preferably, when the connecting structure 22 is accommodated in the sheath tube cavity, the accommodation angle θ1 is equal to 0°; when the puncture assembly 20 is in a natural state, the connecting structure 22 is curved, and the rotation angle θ2 is equal to 180°.

[0048] In this embodiment, the direction of the pushing direction line L1 is the same as the axial direction of the main operating tube 21 and is set toward the distal end, and the direction of the pushing direction line L2 is the direction from the proximal end of the branch tube 21 toward the distal end. As the connecting structure 22 slides in the sheath cavity, the direction of the pushing direction line L2 will change.

[0049] There are multiple suture assemblies 40, and the number of suture assemblies 40 is the same as the number of branch outlets 231, and the suture assemblies 40 and the branch outlets 231 are arranged one by one. The suture assemblies 40 can be slidably accommodated in the push channel. The suture assemblies 40 include an inner suture 52 and an outer suture 51. One end of the outer suture 51 can move to the outside of the heart 200 through the branch outlet 23 and be anchored, and the other end of the outer suture 51 can extend to the outside of the heart 200 through the push inlet 211. One end of the inner suture 52 can move to the inside of the heart 200 through the branch outlet 231 and be anchored, and the other end of the inner suture 52 can move to the outside of the heart 200 through the branch outlet 231. The ends of each inner suture 52 and each outer suture 51 exposed to the outside of the heart 200 form a knot outside the apical hole 220 for locking.

[0050] According to the apical closure device 100 of the present invention, by setting the suturing assembly 40 in the puncture assembly 20, when the apical hole 220 needs to be sutured, the puncture assembly 20 is first stored in the sheath 10 outside the body, and then the sheath 10 is inserted into the apical hole 220, and then the branch tube 23 of the puncture assembly 20 is pushed from the inside of the sheath 10 to the outside of the sheath 10, so that the puncture assembly 20 is in a natural state and the branch tube 23 is set from the inside of the heart 200 to the outside (that is, the branch outlet 231 faces the outside). The puncture assembly 20 is moved toward the proximal end so that the puncture assembly 20 penetrates from the inside of the heart 200 to the outside of the heart 200, and the branch outlet 231 is located on the outside of the heart 200, and at the same time, one end of the outer suture 51 moves to the outside of the heart 200 through the branch outlet 231 and is anchored, and the other end of the outer suture 51 extends to the outside of the heart 200 through the push inlet, and one end of the inner suture 52 extends through the branch outlet 231 and is exposed to the outside of the heart 200, and then the puncture assembly 20 is moved toward the distal end so that the branch tube 23 and the branch outlet 231 are retracted to the inside of the heart 200, and at the same time, the other end of the inner suture 52 moves to the inside of the heart 200 through the branch outlet 231 and is anchored. For anchoring, the inner sutures 52 and the outer sutures 51 in the multiple groups of suture assemblies 40 simultaneously fix the inner and outer sides of the heart 200. Since one end of the outer suture 52 (i.e., the end other than the anchoring with the heart) extends to the outside of the heart 200 through the push inlet 211, and one end of the inner suture 52 (i.e., the end other than the anchoring with the heart) moves to the outside of the heart 200 through the branch outlet 231, the ends of each inner suture 52 and each outer suture 51 exposed to the outside of the heart 200 (i.e., the ends other than the anchoring with the heart) are formed into a knot outside the apical hole 220 for locking, thereby achieving the closure of the apical hole 220, reducing the risk of bleeding, and facilitating the operation, saving operation time.

[0051] Recombination Figures 1 to 3 As shown, the number of branch tubes 23 and connecting structures 22 in this embodiment are both two, and the two branch tubes 23 are symmetrically arranged. The connecting structure 22 is used to connect the main operation tube 21 and the branch tube 23. The connecting structure 22 is in a bent state in a natural state so that the distal end of the branch tube 23 is arranged toward the proximal end of the main operation tube 21. The push tube 30 can be slidably inserted into the push channel. The push tube 30 and the branch tube 23 are arranged one by one. The push tube 30 is inserted into the push inlet 211 and can be slidably arranged in the branch channel corresponding thereto, and can be inserted out of the branch outlet 231 to drive the suturing assembly 40 to anchor the inner and outer sides of the heart 200.

[0052] Combination Figure 4 and Figure 5As shown, the suture assembly 40 of this embodiment further includes an inner anchor 41 and an outer anchor 42, the inner anchor 41 is connected to the inner suture 52, and the outer anchor 42 is connected to the outer suture 51. When the suture assembly 40 is located in the push channel, the outer anchor 42 is closer to the branch outlet 231 than the inner anchor 41 located in the same branch channel. The inner suture 52 passes through the outer anchor 42 and passes through the distal end of the outer anchor 42; the outer suture 51 passes through the inner anchor 41 and the center of the push tube 30, and at least a portion of the outer suture 51 passes through the push inlet 211.

[0053] Among them, the inner anchor 41 includes an inner connecting tube 411, which is detachably connected to the push tube 30 and fixedly connected to the inner suture 52; the outer anchor 42 includes an outer connecting tube 421, which is detachably connected to the push tube 30 and fixedly connected to the outer suture 51.

[0054] In this embodiment, one end of the inner suture 52 is fixed to the inner connecting tube 41, and the other end passes through the lumen of the outer connecting tube 421 to the distal end, so that the inner suture 52 passes through the outer connecting tube 421 and is exposed to the outside of the heart. Specifically, the outer connecting tube 421 is provided with a perforation penetrating its tube wall, and the inner suture 52 can extend into the lumen of the outer connecting tube 421 through the perforation, and extend from the lumen of the outer connecting tube 421 to the outside of the heart.

[0055] One end of the outer suture 51 is fixed to the outer connecting tube 421 , and the other end passes through the inner connecting tube 411 from the lumen of the push tube 30 , and passes out from the proximal end of the push tube 30 and is exposed to the outside of the heart.

[0056] The inner anchor 41 also includes at least one inner fixing claw 412 elastically connected to the inner connecting tube 411. When the inner anchor 41 is in a natural state, the range of the angle θ3 formed by the inner fixing claw 412 and the inner connecting tube 411 is [90°, 0°]; the outer anchor 42 also includes at least one outer fixing claw 422 elastically connected to the outer connecting tube 421. When the inner anchor 41 is in a natural state, the range of the angle θ4 formed by the outer fixing claw 422 and the outer connecting tube 421 is [90°, 0°].

[0057] Further, an inner flow-blocking film 413 is coated between the multiple inner fixing claws 412. The inner flow-blocking film 413 is made of PET material, which covers the surface of the multiple inner fixing claws 412, thereby shielding the puncture hole formed by the puncture assembly 20 on the inner surface of the myocardium, reducing or preventing blood from leaking through the puncture hole. An outer flow-blocking film 423 is coated between the multiple outer fixing claws 422. The outer flow-blocking film 423 is made of PET material, which covers the surface of the multiple outer fixing claws 422, thereby shielding the puncture hole formed by the puncture assembly 20 on the outer surface of the myocardium, reducing or preventing blood from leaking through the puncture hole.

[0058] The main operation tube 21 of this embodiment is a hollow tubular structure with axial holes running through both ends along its axial direction. The connecting structure 22 can be made of a material with shape memory (such as nickel-titanium alloy). When the connecting structure 22 is in a natural state, the proximal end of the connecting structure 22 is connected to the distal end of the main operation tube 21, and the distal end of the connecting structure 22 is bent and extends to the outside of the main operation tube 21. The connecting structure 22 can be deformed to be parallel to the main operation tube 21 by radial force, so as to facilitate installation in the sheath tube 10. The cross-sectional shape of the connecting structure 22 is a semicircular arc, so that the connecting structure 22 has better bending performance.

[0059] The branch tube 23 is connected to the distal end of the connection structure 22, and the branch tube 23 is connected to the connection structure 22 in a one-to-one correspondence. When the connection structure 22 is deformed by the radial force to be parallel to the main operation tube 21, the connection structure 22 can drive the branch tube 23 to move parallel to the main operation tube 21, so that the puncture assembly 20 switches from an expanded state with a larger radial size to a contracted state with a smaller radial size, so that the puncture assembly 20 can be accommodated in the delivery cavity of the sheath tube 10 for delivery. The distal end of the branch tube 23 is a sharp structure to puncture the myocardium.

[0060] The connection structure 22 may be a bellows or a cut tube. The connection structure 22 is laser cut into a sheet from a metal tube (e.g., a nickel-titanium alloy tube) and then connected to the distal end of the main operation tube 21. The sheet-shaped connection structure 22 is then heat-formed to a desired bending shape, and then its distal end is connected to the branch tube 23. The connection method of the connection structure 22 to the main operation tube 21 and the branch tube 23 may be a fixed connection such as welding.

[0061] like Figure 3As shown, the outer suture 51 passes through the inside of the inner anchor 41 and is connected to the outer anchor 42, and the inner suture 52 passes through the inside of the outer anchor 42 and is connected to the inner anchor 41. After the suture assembly 40 fixes the myocardium on both sides of the apical hole, the inner anchor 41 is arranged on the inner side of the heart, and the outer anchor 42 is arranged on the outer side of the heart. When the outer anchor 42 is pulled by the outer suture 51, the outer anchor 42 moves toward the inner anchor 41 because the outer suture 51 passes through the inside of the inner anchor 41. When the inner anchor 41 is pulled by the inner suture 52 to move, the inner anchor 41 moves toward the outer anchor 42 because the inner suture 52 passes through the inside of the outer anchor 42, thereby tightening and squeezing the inner and outer sides of the heart, and forming a knot at the end of the multiple suture assemblies exposed to the outside of the heart, so that the apical hole can be closed.

[0062] Specifically, the inner connecting tube 411, the inner fixing claw 412, the outer connecting tube 421 and the outer fixing claw 422 are formed by heat setting of nickel-titanium alloy material, so that the inner connecting tube 411, the inner fixing claw 412, the outer connecting tube 421 and the outer fixing claw 422 have good biocompatibility and will be endothelialized after being implanted in the body for a period of time. The inner connecting tube 411 and the outer connecting tube 421 are hollow tubular structures with openings at both ends. A plurality of inner fixing claws 412 are arranged on the outer side of the end of the inner connecting tube 411 away from the outer anchor 42, and the other end is a free end, and the inner wall of the free end is provided with an internal thread (not shown in the figure), and the outer surface of part of the distal end of the push tube 30 is provided with an external thread matching the internal thread, and the push tube 30 is threadedly connected to the inner connecting tube 411, so as to facilitate the connection and disassembly between the push tube 30 and the inner anchor 41. A plurality of external fixing claws 422 are arranged on the outer side of the end of the external connecting tube 421 away from the inner anchor 41, and the other end is a free end. The inner wall of the free end is provided with an internal thread (not shown in the figure), and a part of the distal outer surface of the push tube 30 is provided with an external thread matching the internal thread. The push tube 30 and the external connecting tube 421 are threadedly connected, thereby facilitating the connection and disassembly between the push tube 30 and the outer anchor 42.

[0063] Combination Figure 6 and Figure 7As shown, when the inner fixing claw 412 is in a natural state, the inner fixing claw 412 and the inner connecting tube 411 are open at an angle. When the inner fixing claw 412 is subjected to radial compression, the angle between the inner fixing claw 412 and the inner connecting tube 411 decreases, and even deforms to 0°. That is, when the inner fixing claw 412 is subjected to radial compression, the inner fixing claw 412 can be attached to the outer surface of the inner connecting tube 411, so that the suturing assembly 40 can be accommodated in the lumen of the puncture assembly 20. When the inner fixing claw 412 is released from the puncture assembly 20, the inner fixing claw 412 can automatically open at an angle relative to the inner connecting tube 411, so that the inner anchor 41 can be attached to the inner side of the myocardium to form an anchor. The outer anchor 42 is consistent with the inner anchor 41 in the state after being subjected to force.

[0064] The push tube 30 in this embodiment is a hollow structure with openings at both ends. It has certain structural strength and flexibility, so that it can pass through the curved conveying path without being folded, and at the same time, it is convenient for the outer suture 51 to be inserted into the interior of the push tube 30 and connected to the outer anchor 42. The conveying and release of the suture assembly 40 are completed through the push tube 30. The outer surface of the push tube 30 is provided with two sections of threaded structures arranged at intervals, and the number of turns of the thread is 3-5 turns, so that it is easy to disassemble while ensuring the connection strength between the suture assembly 40 and the conveying member 30. The interval between the two sections of thread is about 10mm, and the two are threads in the same direction. The two sections of thread are matched with the internal threads of the connecting pipes of the inner anchor 41 and the outer anchor 42 respectively, so as to be used for the installation and release of the inner anchor 41 and the outer anchor 42.

[0065] Furthermore, the length of the push tube 30 in this embodiment is greater than the length of the sheath tube 10, so that after the puncture assembly 20 performs puncture, the push tube 30 can still be manipulated at the proximal end of the apical closure device 100, thereby completing the release process of the inner anchor 41 and the outer anchor 42.

[0066] Recombination Figure 6 and Figure 7As shown, during assembly, the push tube 30 is first inserted into the proximal port of the main operating tube 21 and exited from the distal port of the branch tube 23, and the inner anchor 41 and the outer anchor 42 are respectively connected to a portion of the distal end of the push tube 30. Then, the push tube 30 is pulled toward the proximal end of the push tube 30, and the inner anchor 41 and the outer anchor 42 are accommodated in the inner cavity of the branch tube 23 together with the push tube 30. Then, the whole formed by the puncture assembly 20, the suturing assembly 40 and the push tube 30 is accommodated together in the inner cavity of the sheath tube 10. Specifically, the proximal portion of the main operating tube 21 of the puncture assembly 20 is inserted into the sheath tube 10 from the distal end of the sheath tube 10, and passes through the proximal end of the sheath tube 10, pulling the proximal end of the main operating tube 21. During the movement of the main operating tube 21 toward the proximal end, the inner wall of the sheath tube 10 provides a radially inward force on the connecting structure 22, thereby deforming the connecting structure 22 (tending to a straight line shape), reducing the overall external size of the puncture assembly 20, and finally making the branch tube 23 parallel to the main operating tube 21, so that the puncture assembly 20 is accommodated in the interior of the sheath tube 10 as a whole. In this process, the main operating tube 21 of the puncture assembly 20 is at least partially exposed to the proximal end of the sheath tube 10, so as to facilitate the operation of the puncture assembly 20, and the push tube 30 and the traction member are at least partially exposed to the proximal end of the main operating tube 21, so as to facilitate the operation of the push tube 30 and the traction member.

[0067] Recombination Figures 8 to 11 As shown, when the apical hole 220 is sutured using the apical closure device 100 of this embodiment, the distal end of the sheath tube 10 is first inserted into the heart 200 along the apical hole 220, as shown in FIG. Figure 8 Keep the sheath tube 10 in place and push the main operating tube 21 to the distal end, so that the connecting structure 22 and the branch tube 23 of the puncture assembly 20 are expanded to a natural state in the heart 200, as shown. Fig. 9 After the puncture assembly 20 is fully deployed in the heart 200, the main operation tube 21 is pulled outward from the body, so that the branch tube 23 can puncture the myocardium 210 and at least the branch outlet of the branch tube 23 is exposed to the outside of the heart 200, and the push tube 30 is pushed toward the distal end to push the outer anchor 42 out of the branch tube 23, as shown in FIG. Fig.10 The puncture assembly 20 is pushed toward the distal end to make the outer anchor 42 hooked on the outer side of the myocardium 210, and the push tube 30 is rotated to release the outer anchor 42 on the outer side of the myocardium 210 from the push tube 30, and the inner suture 52 on the inner anchor 41 is kept on the outer side of the myocardium 210, as shown. Fig.11 The puncture assembly 30 is pushed distally again to withdraw the branch tube 23 from the myocardium 210 and place the branch tube 23 inside the heart 200, and then the push tube 30 is rotated to release the push tube 30 from the outer anchor 42, and then the push tube 30 is pushed distally to push the outer anchor 42 out of the branch tube 23 and make it abut against the inner side of the myocardium 210, as shown in FIG. Fig.12Then, the puncture assembly 20 is pulled toward the proximal end, and the puncture assembly 20 is returned to the sheath tube 10, and the puncture assembly 23 and the push tube 30 are withdrawn from the heart 200. Finally, the outer suture 51 and the inner suture 52 are tightened, and the outer suture 51 and the inner suture 52 located outside the myocardium 210 are knotted to form a knot point 53, so that the apical hole 220 can be closed. The external structure of the apical hole 220 after suturing is shown in FIG. Fig.13 shown.

[0068] Implementation Method 2

[0069] Combination Figure 1 , Fig.14 and Fig.15 As shown, the apical closure device 100 of this embodiment is basically the same as that of the embodiment 1, and includes a sheath tube 10, a puncture assembly 20, a suturing assembly 40 and a push tube 30. Among them, the puncture assembly 20 includes a main operation tube 21, a connecting structure 22 and a branch tube 23. The connecting structure 22 is used to connect the main operation tube 21 and the branch tube 23. The connecting structure 22 is in a bent state in a natural state so that the distal end of the branch tube 23 is arranged toward the proximal end of the main operation tube 21. The push tube 30 is penetrated inside the puncture assembly 20 and can move axially in the delivery channel of the puncture assembly 20. The suturing assembly 40 includes an inner anchor 41 and an outer anchor 42 that are arranged relatively. The inner anchor 41 and the outer anchor 42 are respectively connected to the distal end of the push tube 30 in a detachable manner. After the inner anchor 41 and the outer anchor 42 are separated from the push tube 30, they can tighten and fix the apical hole 220 from the outside and inside of the heart 200 respectively. Different from the first embodiment, the number of the connection structures 22 and the branch tubes 23 in this embodiment is more than two. For the convenience of description, in this embodiment, only six connection structures 22 and six branch tubes 23 are used as an example for explanation. Specifically, the six connection structures 22 are arranged in an annular shape at equal intervals in a bent state, and the six branch tubes 23 are arranged in an annular shape at equal intervals in a bent state of the connection structure 22, and each branch tube 23 is provided with a suture assembly 40. Therefore, in the process of closing the apical hole 220, the apical hole 220 can be anchored at six positions at the same time, making the anchoring position more uniform, and making the sutured apical hole 200 more closed, preventing the occurrence of bleeding.

[0070] Implementation Method 3

[0071] Combination Figure 1 , Fig.16 , Fig.17 , Fig.18 and Fig.19As shown, the apical closure device 100 of this embodiment is basically the same as that of the embodiment 1, and includes a sheath tube 10, a puncture assembly 20, a suturing assembly 40 and a push tube 30. Among them, the puncture assembly 20 includes a main operation tube 21, two connecting structures 22 and two branch tubes 23. The connecting structure 22 is used to connect the main operation tube 21 and the branch tube 23. The connecting structure 22 is in a bent state in a natural state so that the distal end of the branch tube 23 is arranged toward the proximal end of the main operation tube 21. The push tube 30 is penetrated inside the puncture assembly 20 and can move along the axial direction of the puncture assembly 20. The suturing assembly 40 includes an inner anchor 41 and an outer anchor 42 that are arranged relatively. The inner anchor 41 and the outer anchor 42 are respectively connected to the distal end of the push tube 30 in a detachable manner. After the inner anchor 41 and the outer anchor 42 are separated from the push tube 30, they can tighten and fix the apical hole 220 from the outer and inner sides of the heart 200 respectively. Furthermore, the apex closure device 100 of this embodiment further includes a gasket 60 .

[0072] The gasket 60 is provided with connecting holes, which are connecting holes 61 and connecting holes 62 in this embodiment. The number of connecting holes (61, 62) is the same as the number of outer sutures 51, or can be different from the number of outer sutures 51, as long as the outer sutures 51 can pass through the connecting holes.

[0073] In this embodiment, the number of the connecting holes is the same as the number of the outer sutures 51 and are arranged in a one-to-one correspondence.

[0074] The two outer sutures in this embodiment pass through the two connecting holes (61, 62) respectively, and the gasket 60 can slide along the outer suture 51 to the inside of the heart. When the ends of each outer suture 51 and each inner suture 52 exposed to the outside of the heart form a knot for locking, the gasket 60 can generate a radial restraining force on the outer suture, preventing the outer suture 51 from generating a radial outward expansion force on the myocardium at the apical hole, thereby preventing the outer suture 51 from expanding the apical hole.

[0075] Specifically, after the suture assembly 40 completes the anchoring of the apical hole 220, the puncture assembly 20 and the push tube 30 are withdrawn, and the gasket 60 is pushed into the sheath tube 10 from the proximal end of the sheath tube 10, and the proximal end of the outer suture 51 is passed through the gasket 60. Among them, the gasket 60 is provided with a first connection hole 61 and a second connection hole 62 arranged at intervals, and the number of the connection holes corresponds to the number of the suture assemblies 40. The proximal ends of the two inner sutures 52 on both sides of the apical hole 220 pass through the first connection hole 61 and the second connection hole 62 respectively. The gasket 60 is transported to the distal end of the sheath tube 10 along the axial direction of the sheath tube 10 and is located in the heart 200, and then the sheath tube 10 is withdrawn. Under the action of the blood pressure in the heart 200, the gasket 60 will be tightly attached to the edge of the apical hole 220, thereby being able to effectively disperse the radial pressure of the outer suture 51, reduce the radial squeezing force between the outer suture 51 and the apical hole 220, and prevent the outer suture 51 from expanding the apical hole outward.

[0076] The above is only a preferred specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed by the present invention should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. An apical closure device for closing the apical hole of the heart. It is characterized in that include: a sheath having a sheath lumen; The puncture assembly has a push channel, the push channel includes a push inlet and a plurality of branch outlets communicating with the push inlet, the branch outlets have a push direction line for pushing outward along the central axis thereof, and the push inlet has a push direction line for pushing inward along the central axis thereof, when the puncture assembly slides relative to the sheath tube until the plurality of branch outlets are accommodated in the sheath tube cavity, the range of the accommodation angle θ1 formed by the push direction lines of the plurality of branch outlets and the push direction lines is [0°, 15°]; when the puncture assembly slides relative to the sheath tube until the plurality of branch outlets are accommodated in the sheath tube cavity, the range of the accommodation angle θ1 formed by the push direction lines of the plurality of branch outlets and the push direction lines is [0°, 15°]; when the puncture assembly slides relative to the sheath tube When the sheath tube slides so that the puncture assembly is in a natural state, the range of the rotation angle θ2 between the push-out direction line of the plurality of branch outlets and the push-in direction line is (90°, 180°], wherein the puncture assembly comprises a plurality of connection structures, a main operation tube and a plurality of branch tubes, each of the branch tubes is connected to the main operation tube through a connection structure, and the outlet of the branch tube at its free end is the branch outlet, and when the puncture assembly is in a natural state, the plurality of connection structures are curved and arranged in an annular shape at equal intervals, and the plurality of branch tubes are arranged in an annular shape at equal intervals; A suturing assembly, wherein the number of the suturing assemblies is the same as the number of the branch outlets and the suturing assemblies are arranged one-to-one correspondingly to the branch outlets, the suturing assemblies can be slidably accommodated in the pushing channel, the suturing assembly comprises a plurality of outer sutures and a plurality of inner sutures, one end of the outer suture can be moved to the outside of the heart through the branch outlet and anchored, and the other end of the outer suture can be extended to the outside of the heart through the pushing inlet, one end of the inner suture can be moved to the inside of the heart through the branch outlet and anchored, and the other end of the inner suture can be moved to the outside of the heart through the branch outlet, and the ends of each outer suture and each inner suture exposed to the outside of the heart can form a knot together outside the apical hole for locking.

2. The apical closure device according to claim 1, It is characterized in that When the connecting structure is accommodated in the sheath cavity, the accommodation angle θ1 is equal to 0°; when the puncture assembly is in a natural state, the rotation angle θ2 is equal to 180°.

3. The apical closure device according to claim 1 or 2, It is characterized in that The connecting structure forms a connecting channel, the branch pipe forms a branch channel, each of the branch channels is connected to the connecting channel one-to-one, the main operating pipe forms a main channel, the entrance of the main operating pipe away from the branch outlet is the push entrance, each of the branch channels is connected to the main channel through the connecting channel connected thereto, each of the branch channels, each of the connecting channels and the main channel are connected and together form the push channel.

4. The apical closure device according to claim 3, It is characterized in that The connecting structure is a corrugated tube or a cutting tube.

5. The apical closure device according to claim 3, It is characterized in that The suturing assembly also includes an outer anchor and an inner anchor, the outer anchor is connected to the outer suture, and the inner anchor is connected to the inner suture. When the suturing assembly is located in the pushing channel, the outer anchor is closer to the branch outlet than the inner anchor located in the same branch channel, the outer suture passes through the inner anchor and out of the pushing entrance, the inner suture passes through the outer anchor, and at least a portion of the inner suture is closer to the branch outlet than the outer anchor.

6. The apical closure device according to claim 5, It is characterized in that The apex closure device also includes a plurality of push tubes, which are slidably arranged in the push channel. The number of the push tubes is the same as the number of the branch outlets, and the push tubes are arranged in a one-to-one correspondence with the branch tubes. The push tubes are inserted into the push inlet and are slidably arranged in the corresponding branch channel.

7. The apical closure device according to claim 6, It is characterized in that The outer anchor includes an outer connecting tube, which is detachably connected to the push tube and fixedly connected to the outer suture; the inner anchor includes an inner connecting tube, which is detachably connected to the push tube and fixedly connected to the inner suture, and the inner connecting tube is located proximal to the outer connecting tube.

8. The apical closure device according to claim 7, It is characterized in that The free end of the outer suture passes through the tube cavity of the push tube to the proximal side, and the free end of the inner suture passes through the tube cavity of the outer connecting tube to the distal side.

9. The apical closure device according to claim 7, It is characterized in that The outer anchor also includes at least one outer fixing claw elastically connected to the outer connecting tube. When the outer anchor is in a natural state, the range of the angle θ3 formed by the outer fixing claw and the outer connecting tube is 0°<θ3≤90°; the inner anchor also includes at least one inner fixing claw elastically connected to the inner connecting tube. When the inner anchor is in a natural state, the range of the angle θ4 formed by the inner fixing claw and the inner connecting tube is 0°<θ4≤90°.

10. The apical closure device according to claim 1, It is characterized in that The apex closure device also includes a gasket, which is provided with a connecting hole. The outer sutures are all passed through one of the connecting holes. The gasket can slide along the outer sutures to the inside of the heart. When the ends of each outer suture and each inner suture exposed to the outside of the heart form knots for locking, the gasket can generate radial restraint force on the outer sutures.

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