Patent foramen ovale suture device and patent foramen ovale suture system

Abstract

The present invention relates to a patent foramen ovale suture device and a patent foramen ovale suture system, wherein the patent foramen ovale suture device comprises a puncture needle, a control unit and a clamping unit that can be opened and closed radially, the clamping unit comprises a sheath and a clamping arm, the control unit comprises a first control rod and a second control rod, the clamping arm is hinged with the sheath, the first control rod is movably arranged in the sheath, the distal end of the first control rod is hinged with the clamping arm and can control the clamping arm and the sheath to switch between a closed state and an open state, the second control rod is movably arranged in the sheath, the distal end of the second control rod is connected to the puncture needle and can drive the puncture needle to move relative to the clamping arm, so as to drive the puncture needle to cooperate with the clamping arm in the open state to puncture and pass the suture thread through the primary septum or the secondary septum. According to the patent foramen ovale suture device of the present invention, it is not necessary to implant a large-sized occluder, avoid rejection reaction, will not cause a significant decrease in blood flow at the suture site, and does not require the use of anticoagulant drugs.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a patent foramen ovale suture device and a patent foramen ovale suture system. Background Art

[0002] Patent foramen oval (PFO) is a congenital heart disease characterized by the formation of a hole-like passage between the left atrium and the right atrium. The formation of the foramen ovale occurs when the embryo develops to the 6th or 7th week. The atrial septum gives off two septa in succession. The first septum is called the primary septum or the first septum, and the second septum is called the secondary septum or the second septum. The secondary septum stops growing and separates the atria, so that the primary septum and the secondary septum at the oval fossa fail to adhere and fuse, leaving a gap called the foramen ovale. Currently, the most mature treatment method is to place a metal occluder at the foramen ovale position through femoral vein intervention to close the passage between the original left atrium and the right atrium. However, the anatomical structure of the foramen ovale is often complex, and the risk of displacement of the occluder after implantation is high. In addition, in patients with some complex patent foramen ovale, such as long tunnels and tunnels longer than 9 mm, the occluder cannot be implanted. In addition, after the occluder is implanted in the human body, there are still problems such as rejection and the right atrial venous blood easily forming thrombi on the right disc side. Suturing the primary septum and the secondary septum together with sutures can make the primary septum and the secondary septum contact and adhere to each other, thereby blocking the foramen ovale, instead of using an occluder to block the foramen ovale. However, due to the complexity of the anatomical structure of the foramen ovale, how to pass the sutures through the primary septum or the secondary septum is a problem that needs to be solved. Summary of the invention

[0003] The purpose of the present invention is to at least solve the problem of how to thread the suture thread through the primary septum or the secondary septum. In view of the defects of the prior art, a patent foramen ovale suture device is provided.

[0004] The present invention solves the technical problem by the following technical solutions:

[0005] According to a first aspect of the present invention, a patent foramen ovale suture device is provided, the patent foramen ovale suture device comprising a puncture needle, a control portion and a clamping portion capable of radially opening and closing, the clamping portion comprising a sheath and a clamping arm, the clamping arm being hinged to the sheath, the control portion comprising a first control rod and a second control rod, the first control rod being movably disposed in the sheath, the distal end of the first control rod being hinged to the clamping arm and capable of controlling the clamping arm and the sheath to switch between a closed state and an open state, the second control rod being movably disposed in the sheath, the distal end of the second control rod being connected to the puncture needle and capable of driving the puncture needle to move relative to the clamping arm, so as to drive the puncture needle to cooperate with the clamping arm in the open state to puncture and pass the suture thread through the primary septum or the secondary septum.

[0006] In some embodiments, the control unit also includes: a handle, to which the proximal end of the sheath is connected; a first slider, slidably disposed on the handle along the axial direction, to which the proximal end of the first control rod is connected; and a second slider, slidably disposed on the handle along the axial direction, to which the proximal end of the second control rod is connected.

[0007] In some embodiments, the second slider is arranged closer to the proximal end of the handle than the first slider; the control part also includes a limiting spring piece, and in the direction from the distal end of the handle to the proximal end of the handle, the limiting spring piece includes a first section, a second section, a rotating connection section and a third section connected in sequence, and the rotating connection section is located between the first slider and the second slider and is hinged to the bottom wall of the handle; along the radial direction, the first section and the second section are located between the first slider and the bottom wall of the handle, and the first section is warped and bent in the direction close to the first slider; wherein, in the open state, the first slider abuts against the second section, and the proximal end of the third section avoids the second slider, and in the closed state, the first slider abuts against the first section, and the proximal end of the third section can abut against the distal end face of the second slider.

[0008] In some embodiments, the limiting spring sheet further includes an elastic section, the elastic section is connected to the first section, the elastic section is bent in a direction away from the first sliding block and abuts against a bottom wall of the handle.

[0009] In some embodiments, the limiting spring sheet is provided with a mounting hole, and the control part further includes a torsion spring, wherein the torsion spring is mounted on the rotating connection part and the swing arm of the torsion spring passes through the mounting hole and abuts against the handle, and the torsion spring applies an elastic force to the limiting spring sheet to drive the proximal end of the third section to rotate toward the bottom wall of the handle.

[0010] In some embodiments, one end of the first sliding block facing the limiting spring sheet is provided with a sliding portion protruding toward the limiting spring sheet, and the outer contour of the sliding portion is set to be an arc-shaped curved surface.

[0011] In some embodiments, a stop wall extending along the radial direction is provided inside the handle, the first slider is arranged closer to the distal end of the handle than the stop wall, and the second slider is arranged closer to the proximal end of the handle than the stop wall; the control part also includes an elastic member, which is arranged between the first slider and the stop wall along the axial direction and is respectively connected to the first slider and the second slider, and the elastic member applies an elastic force toward the distal end of the handle to the first slider.

[0012] In some embodiments, the stop wall is provided with a guide hole passing through the proximal end and the distal end of the stop wall, and the control part also includes a guide rod, which is slidably inserted into the guide hole, and the distal end of the guide rod is connected to the first slider, and the elastic member is sleeved outside the guide rod.

[0013] In some embodiments, the first control rod includes a flexible section connected to the first slider and a support section connected to the distal end of the flexible section, the distal end of the support section is hinged to the clamping arm, and the elastic deformation capacity of the flexible section along the axial direction is greater than the elastic deformation capacity of the support section along the axial direction.

[0014] According to a second aspect of the present invention, a patent foramen ovale suture system is further provided, the patent foramen ovale suture system comprising two patent foramen ovale suture instruments as described in the technical solution of the first aspect, the clamping arms of the patent foramen ovale suture instruments being provided with a first hinged portion and a second hinged portion arranged at intervals, the first hinged portion being hinged to the sheath, and the distal end of the first control rod being hinged to the second hinged portion; the clamping arm having a connecting end connected to the sheath and a free end not connected to the sheath; the first hinged portion of one of the two patent foramen ovale suture instruments being located between the free end and the second hinged portion and being used to capture the primary septum, and the second hinged portion of the other patent foramen ovale suture instrument being located between the free end and the first hinged portion and being used to capture the secondary septum.

[0015] According to the patent foramen ovale suture device proposed in the present invention, the clamping part is used to capture the primary septum or the secondary septum, and then the suture thread is passed through the primary septum or the secondary septum through the cooperation of the puncture needle and the clamping part, thereby providing a prerequisite for suturing the primary septum and the secondary septum, so as to replace the occluder for the treatment of patent foramen ovale. Therefore, compared with the occluder, it is not limited by the size of the patent foramen ovale and is suitable for the treatment of all patients with patent foramen ovale; there is no need to implant a large-sized occluder, which avoids rejection reaction, does not cause a significant decrease in blood flow at the suture site, has no risk of thrombosis, and does not require the use of anticoagulant drugs. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] 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:

[0017] Figure 1a It is a schematic structural diagram of a patent foramen ovale suture device for capturing and suturing a secondary septum according to an embodiment of the present invention;

[0018] Figure 1b It is a schematic structural diagram of a patent foramen ovale suture device for capturing and suturing a primary septum according to another embodiment of the present invention;

[0019] Figure 2 It is a schematic diagram of the suturing process of inserting a patent foramen ovale suture device along the inferior vena cava to the foramen ovale according to one embodiment of the present invention;

[0020] Figure 3a It is a schematic diagram of the process of suturing the septum secundum using a patent foramen ovale suture device according to an embodiment of the present invention;

[0021] Figure 3b A schematic diagram of a process of suturing a primary septum using a patent foramen ovale suture device according to another embodiment of the present invention;

[0022] Figure 4 It is a partial structural schematic diagram of a patent foramen ovale suture device for capturing and suturing a primary septum according to an embodiment of the present invention;

[0023] Figure 5 It is a partial structural schematic diagram of a patent foramen ovale suture device for capturing and suturing a secondary septum according to another embodiment of the present invention;

[0024] Figure 6 It is a schematic diagram of a clamping part of a patent foramen ovale suture device for capturing and suturing a primary septum in an open state according to an embodiment of the present invention;

[0025] Figure 7 It is a schematic diagram of a clamping part of a patent foramen ovale suture device for capturing and suturing a primary septum in a closed state according to an embodiment of the present invention;

[0026] Figure 8 It is a schematic diagram of suturing the primary septum using a patent foramen ovale suturer for capturing and suturing the primary septum according to one embodiment of the present invention;

[0027] Fig. 9 It is a schematic structural diagram of a control portion and a sheath tube of a patent foramen ovale suture device according to an embodiment of the present invention;

[0028] Fig.10 It is a schematic cross-sectional structure diagram of a control portion of a suture of a patent foramen ovale suture device according to an embodiment of the present invention;

[0029] Fig.11 It is a schematic structural diagram of a first slider, a first control knob, a second slider, and a second control knob according to an embodiment of the present invention;

[0030] Fig.12 It is a schematic structural diagram of a first control rod, a first slider, a first control knob, a stop wall and an elastic member according to an embodiment of the present invention;

[0031] Fig.13It is a schematic diagram of the handle and the first control knob of the patent foramen ovale suture device in a closed state according to an embodiment of the present invention;

[0032] Fig.14 It is a schematic diagram of the handle and the first control knob of the patent foramen ovale suture device in an open state according to an embodiment of the present invention;

[0033] Fig.15 It is a partially enlarged schematic diagram of the handle and the first control knob of the patent foramen ovale suture device in an open state according to an embodiment of the present invention;

[0034] Fig.16 It is a partially enlarged schematic diagram of the handle and the first control knob of the patent foramen ovale suture device in a closed state according to an embodiment of the present invention;

[0035] Fig.17 It is a schematic diagram of the internal structure of the handle of the patent foramen ovale suture device according to one embodiment of the present invention;

[0036] Fig.18 for Fig.17 A partial enlarged schematic diagram of part A;

[0037] Fig.19 It is a schematic structural diagram of a first slider, a second slider, a lower shell and a limiting spring piece of a patent foramen ovale suture device in an open state according to an embodiment of the present invention;

[0038] Fig. 20 It is a schematic structural diagram of a first slider, a second slider, a lower shell and a limiting spring piece of a patent foramen ovale suture device in a closed state according to an embodiment of the present invention;

[0039] Fig.21 A schematic structural diagram of a first sliding block according to an embodiment of the present invention;

[0040] Fig. 22 It is a schematic structural diagram of a limiting spring piece at a first viewing angle according to an embodiment of the present invention;

[0041] Fig.23 It is a schematic structural diagram of a limiting spring piece at a second viewing angle according to an embodiment of the present invention;

[0042] Fig.24 It is a schematic structural diagram of a limiting spring piece at a first viewing angle according to another embodiment of the present invention;

[0043] Fig.25 It is a schematic structural diagram of a limiting spring piece at a second viewing angle according to another embodiment of the present invention;

[0044] Fig.26 It is a schematic structural diagram of a limiting spring piece at a first viewing angle according to another embodiment of the present invention;

[0045] Fig. 27 It is a schematic structural diagram of a limiting spring piece at a second viewing angle according to another embodiment of the present invention;

[0046] Fig.28 A schematic structural diagram of a limiting spring piece at a first viewing angle according to yet another embodiment of the present invention;

[0047] Fig.29 It is a schematic structural diagram of a limiting spring piece at a second viewing angle according to yet another embodiment of the present invention;

[0048] Fig.30 It is a schematic structural diagram of a first control rod, a first slider, a first control knob, a second slider and a second control knob according to an embodiment of the present invention;

[0049] Fig.31 It is a schematic structural diagram of a first control rod, a first slider, a first control knob, a second slider and a second control knob according to another embodiment of the present invention.

[0050] The reference numerals in the accompanying drawings represent the following:

[0051] 100. Patent foramen ovale suture device;

[0052] 10. Clamping portion; 11. Sheath tube; 111. Distal segment; 1111. Accommodating groove; 1112. Puncture port; 112. Proximal segment; 114. Second channel; 115. Exhaust hole;

[0053] 12, clamping arm; 121, first hinged portion; 122, second hinged portion; 123, puncture hole; 1201, connecting end; 1202, free end;

[0054] 20. Control unit; 21. First control rod; 211. Flexible section; 212. Support section; 22. Second control rod;

[0055] 23, handle; 231, upper shell; 2311, slide hole; 2312, limit hole; 2313, first identification area; 2314, second identification area; 232, lower shell; 233, accommodating cavity; 234, stop wall; 2341, guide hole; 2301, bottom wall; 235, first slide; 236, second slide;

[0056] 24, first slider; 241, sliding portion; 242, through hole; 243, slide groove; 244, boss; 25, second slider;

[0057] 26, limit spring; 260, main board; 261, first section; 262, second section; 263, third section; 264, rotating connection part; 265, elastic section; 266, mounting hole;

[0058] 27, torsion spring; 271, swing arm; 28, elastic member; 29, guide rod; 210, first control knob; 2101, indicator needle; 2102, slide rail; 220, second control knob; 2201, driving unit; 230, connecting rod;

[0059] 30. puncture needle; 301. secundum septum; 302. primary septum; 303. foramen ovale. DETAILED DESCRIPTION

[0060] 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.

[0061] 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.

[0062] 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.

[0063] 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 rotated, 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 above and below orientations.

[0064] It should be noted that "distal" and "proximal" are used as directional terms, which are commonly used terms in the field of interventional medical devices, where "distal" refers to the end away from the doctor during the operation, and "proximal" refers to the end close to the doctor during the operation. The patent foramen ovale suture device has a proximal end and a distal end, where the axial direction is defined as the direction parallel to the line connecting the distal center and the proximal center of the patent foramen ovale suture device; the radial direction refers to the direction perpendicular to the above-mentioned axial direction.

[0065] According to the embodiment of the present invention, please combine Figure 1a , Figure 2 , Figure 3a , Figure 3b and Figure 6 As shown, a patent foramen ovale suture device 100 is proposed, comprising: a puncture needle 30, a control unit 20, and a clamping unit 10 that can be opened and closed in the radial direction. The control unit 20 can control the clamping unit 10 to switch between a closed state and an open state to capture the secondary septum 301 or the primary septum 302. In the open state, the control unit 20 can also control the puncture needle 30 to cooperate with the clamping unit 10 to pass the suture through the secondary septum 301 or the primary septum 302. The use of suturing instead of an occluder to treat patent foramen ovale is not limited by the size of the patent foramen ovale and is suitable for the treatment of all patients with patent foramen ovale; there is no need to implant a large-sized occluder, which avoids rejection reactions, does not cause a significant decrease in blood flow at the suture site, has no risk of thrombosis, and does not require the use of anticoagulant drugs.

[0066] Specifically, Figure 4 and Figure 5As shown, the clamping portion 10 includes a sheath 11 and a clamping arm 12, the control portion 20 includes a first control rod 21 and a second control rod 22, the sheath 11 includes a connected distal segment 111 and a proximal segment 112, the proximal end of the distal segment 111 is connected to the distal end of the proximal segment 112, the distal segment 111 is provided with a receiving groove 1111 extending along its axial direction, the receiving groove 1111 forms an opening on the outer peripheral surface of the distal segment 111, the clamping arm 12 and the distal segment 111 are hinged by a pin, the first control rod 21 can be movably penetrated in the sheath 11, the distal end of the first control rod 21 is hinged to the clamping arm 12 by a pin, when the first control rod 21 moves axially relative to the sheath 11, the first control rod 21 can drive the clamping arm 12 to rotate relative to the sheath 11, so that the clamping arm 12 and the sheath 11 are switched between a closed state and an open state. In the closed state, the clamping arm 12 is received in the receiving groove 1111. In the open state, the free end 1202 of the clamping arm 12 extends out of the receiving groove 1111, and one end between the clamping arm 12 and the distal segment 111 of the sheath tube 11 is open, so that the primary septum or the secondary septum can enter between the clamping arm 12 and the sheath tube 11 through the opening and be clamped and fixed by the clamping arm 12 and the sheath tube 11.

[0067] like Figure 2 As shown, during the process of inserting the distal end of the patent foramen ovale suture device 100 into the foramen ovale, it is necessary to control the clamping portion 10 to remain in a closed state, so as to facilitate passing through the tortuous blood vessels and smoothly reaching the foramen ovale. Figure 3a and Figure 3b As shown, after the clamping part 10 is inserted into the foramen ovale, the opening and closing action of the clamping part 10 is controlled by the first control rod 21, so that the secondary septum 301 or the primary septum 302 can enter into the clamping part 10 through its opening when the clamping part 10 is in an open state. After it is determined that the secondary septum 301 or the primary septum 302 enters into the clamping part 10, the secondary septum 301 or the primary septum 302 can be captured by precisely controlling the opening angle of the clamping arm 12 and the sheath 11, so as to achieve the capture of the secondary septum 301 or the primary septum 302.

[0068] Please combine Figure 7 , Figure 8 and Fig.11As shown, the second control rod 22 is movably disposed in the sheath tube 11, and the distal end of the second control rod 22 is connected to the puncture needle 30 and can drive the puncture needle 30 to move relative to the clamping arm 12, so as to drive the puncture needle 30 to cooperate with the clamping arm 12 in the open state for puncture. Specifically, the sheath tube 11 is provided with a first channel (not shown in the figure) and a second channel 114, the proximal end of the second channel 114 forms an opening at the proximal end of the sheath tube 11, and the distal end of the second channel 114 extends to the receiving groove 1111, the first control rod 21 is movably disposed in the second channel 114, the first channel extends along the axial direction of the sheath tube 11, the puncture needle 30 and the second control rod 22 are both disposed in the first channel, the distal end of the first channel forms a puncture opening 1112 on the outer peripheral surface of the sheath tube 11 for the puncture needle 30 to extend, and the clamping arm 12 is provided with a puncture hole 1111 that cooperates with the puncture needle 30. 23. After the clamping portion 10 captures the secondary septum 301 or the primary septum 302, the second control rod 22 is driven to move toward the distal end. The puncture needle 30 extends from the puncture port 1112 to penetrate the secondary septum 301 or the primary septum 302 and then extends into the puncture hole 123 of the clamping arm 12. The puncture hole 123 is provided with a suture. When the needle head of the puncture needle 30 is inserted into the puncture hole 123, the suture is hooked so that the suture can move with the needle head. The second control rod 22 is driven to move toward the proximal end. The puncture needle 30 drives the suture to pass through the secondary septum 301 or the primary septum 302 to complete the suturing operation.

[0069] In other embodiments, an anchor rod (not shown in the figure) is provided at the distal end of the inner cavity of the puncture needle 30, one end of the suture is connected to the anchor rod, and the other end of the suture extends from the anchor rod and is wound around a coil (not shown in the figure) disposed in the handle. When the puncture needle 30 passes through the primary septum or the secondary septum and is inserted into the puncture hole 123 of the clamping arm 12, the anchor rod is pushed out from the distal end of the puncture needle 30 by a driving rod (not shown in the figure) disposed in the puncture needle 30, and the anchor rod together with the suture is stuck in the puncture hole 123, so that the anchor rod is connected to the clamping arm 12 by clamping, and then the puncture needle 30 is withdrawn. At this time, the distal end of the suture is fixed to the clamping arm 12 through the anchor rod, and then during the process of withdrawing the patent foramen ovale suturer as a whole, the distal end of the suture is withdrawn with the clamping arm 12, and finally the suture in a folded state is left on the primary septum or the secondary septum.

[0070] In this embodiment, please combine Figure 4 and Figure 5 As shown, the clamping arm 12 is provided with a first hinged portion 121 and a second hinged portion 122 which are spaced apart. The first hinged portion 121 is hinged to the sheath tube 11 via a pin, and the distal end of the first control rod 21 is hinged to the second hinged portion 122. Thus, by driving the first control rod 21 to move axially relative to the sheath tube 11, the second hinged portion 122 can be driven to rotate around the first hinged portion 121, thereby causing the clamping arm 12 to rotate as a whole relative to the sheath tube 11 to switch between a closed state and an open state.

[0071] In some embodiments, the first hinged portion 121 is a first through hole (not shown in the figure) provided on the clamping arm 12, and a second through hole (not shown in the figure) opposite to the first through hole is provided on the sheath tube 11, and a pin is sequentially passed through the first through hole and the second through hole to achieve the hinge connection between the first hinged portion 121 and the sheath tube 11. The second hinged portion 122 is configured as a third through hole (not shown in the figure) provided on the clamping arm 12, and a fourth through hole (not shown in the figure) opposite to the third through hole is provided on the first control rod 21, and another pin is sequentially passed through the third through hole and the fourth through hole to achieve the hinge connection between the second hinged portion 122 and the first control rod 21.

[0072] In this embodiment, Figure 4 and Figure 5 As shown, the clamping arm 12 has a connection end 1201 connected to the sheath tube 11 and a free end 1202 not connected to the sheath tube 11 .

[0073] In some embodiments, please combine Figure 3a and Figure 5 As shown, the second hinged portion 122 is located between the free end 1202 and the first hinged portion 121, and the hinged position of the first hinged portion 121 and the sheath 11 is located at the proximal end of the accommodating groove 1111, and a V-shaped structure or a U-shaped structure with a distal opening is formed between the clamping arm 12 and the distal segment 111 of the sheath 11. The patent foramen ovale suture device 100 in this embodiment is used to capture the secondary septum 301 and pass the suture thread on the secondary septum 301.

[0074] In other embodiments, please combine Figure 3b and Figure 4 As shown, the first hinged portion 121 is located between the free end 1202 and the second hinged portion 122, and the hinged position of the first hinged portion 121 and the sheath 11 is located at the distal end of the accommodating groove 1111, and a V-shaped structure or a U-shaped structure with a proximal opening is formed between the clamping arm 12 and the distal segment 111 of the sheath 11. The patent foramen ovale suture device 100 in this embodiment is used to capture the primary septum 302 and pass the suture thread on the primary septum 302.

[0075] In this embodiment, Fig. 9 and Fig.10 As shown, the control unit 20 further includes a handle 23, a first slider 24, and a second slider 25. The handle 23 is convenient for the doctor to hold, and the handle 23 is used to operate and control the oval foramen suture surgery. Specifically, the handle 23 includes an upper shell 231 and a lower shell 232 that are snap-fitted together, and the upper shell 231 and the lower shell 232 jointly define a receiving cavity 233 for receiving the first slider 24 and the second slider 25.

[0076] The proximal end of the sheath tube 11 extends into the accommodating cavity 233 and is fixedly connected to the handle 23 by fasteners. The proximal end of the sheath tube 11 is provided with an exhaust hole 115 for exhausting the air in the sheath tube 11. The connector of the exhaust hole 115 can be a 6% standard Luer connector, or can be set to a Luer connector of other specifications according to requirements.

[0077] From the proximal end of the handle to the distal end of the handle 23, the second slider 25 and the first slider 24 are sequentially arranged in the accommodating cavity 233, the bottom wall 2301 of the lower shell 232 is provided with a first slide 235 and a second slide 236 arranged in a radial interval, the first slide 235 and the second slide 236 are arranged as a long strip structure extending in the axial direction, and the first slider 24 is provided with a boss 244 at one end facing the bottom wall 2301, the boss 244 is sandwiched between the first slide 235 and the second slide 236, and the first slider 235, the second slide 236 and the boss 244 are slidably matched to limit the first slider 24 from sliding in the accommodating cavity 233 in the axial direction. The proximal end of the first control rod 21 extends from the proximal end of the sheath tube 11 into the accommodating cavity 233 and is connected to the distal end of the first slider 24. The first slider 24 drives the first control rod 21 to move relative to the sheath tube 11 in the axial direction during the sliding process, thereby realizing the closing or opening of the clamping part 10.

[0078] like Fig.11 and Fig.12 As shown, a through hole 242 is provided on the first slider 24, and the proximal end of the second control rod 22 passes through the through hole 242 and is connected to the distal end of the second slider 25, wherein the second control rod 22 and the first slider 24 are clearance-matched, so that the second control rod 22 can slide in the through hole 242, so that the movement of the first slider 24 and the movement of the second control rod 22 do not interfere with each other. In this embodiment, the sliding connection structure between the second slider 25 and the lower shell 232 is the same as that of the first slider 24, and will not be repeated here. In the process of the second slider 25 sliding axially relative to the handle 23, the second slider 25 drives the second control rod 22 to move axially relative to the sheath 11, thereby realizing the puncture action of the puncture needle 30 and completing the suturing action.

[0079] In this embodiment, please combine Fig. 9 and Fig.11As shown, the control part 20 further includes a first control knob 210, a second control knob 220 and a connecting rod 230. The upper shell 231 of the handle 23 is provided with a sliding hole 2311 extending in the axial direction. The first control knob 210 can be slidably inserted into the sliding hole 2311 and connected to the first slider 24. By manipulating the first control knob 210, the first slider 24 can be driven to slide in the accommodating cavity 233. The second control knob 220 is hinged to the handle 23. The second control knob 220 is provided with a driving part 2201. The connecting rod 230 is hinged to the second slider 25 and the driving part 2201 respectively, and the driving part 2201 is arranged to deviate from the rotation axis of the second control knob 220. The handle 23, the second slider 25, the connecting rod 230 and the second control knob 220 jointly construct a crank slider mechanism. By rotating the second control knob 220, the second slider 25 can be driven to slide in the accommodating cavity 233. In this embodiment, a crank slider mechanism is constructed by the handle 23, the second slider 25, the connecting rod 230 and the second control knob 220. During the rotation of the second control knob 220, the axial sliding distance of the second slider 25 is controllable compared to the manual pushing of the second slider 25. This can effectively control the moving distance of the puncture needle 30 when performing the puncture action, thereby preventing the puncture needle 30 from injuring myocardial tissue in other areas except the secondary septum 301 and the primary septum 302.

[0080] In some embodiments, please combine Fig.13 , Fig.14 , Fig.15 and Fig.16 As shown, the first control knob 210 is provided with an indicator needle 2101, and the outer side wall of the handle 23 is also provided with a first identification area 2313 and a second identification area 2314 arranged in sequence along the axial direction. In the closed state, the indicator needle 2101 points to the first identification area 2313, and in the open state, the indicator needle 2101 points to the second identification area 2314. The first identification area 2313 and the second identification area 2314 can be set to different colors, for example, the first identification area 2313 is set to red, and the second identification area 2314 is set to blue. When the clamping arm 12 captures the secondary septum 301 or the primary septum 302, the clamping arm 12 cannot be closed. Accordingly, the first control knob 210 cannot move to the distal end. At this time, the first control knob 210 is located at the proximal end of the handle 23, and the indicator needle 2101 points to the blue area of ​​the identification, that is, the second identification area 2314. If the clamping arm 12 fails to capture the tissue, the clamping arm 12 is closed, and accordingly, the first control knob 210 can slide to the distal end, pointing to the red area, i.e., the first identification area 2313. In this embodiment, the capture state of the secondary septum 301 or the primary septum 302 can be accurately determined by setting the first identification area 2313 and the second identification area 2314, so as to assist the doctor in determining whether the suturing conditions are met, simplify the surgical operation, increase the determination of whether the capture is successful before puncture, avoid the situation of puncturing when the clamping is unsuccessful, and increase the success rate of suturing.

[0081] In other embodiments, the first identification area 2313 and the second identification area 2314 may not be provided, but the distal segment 111 and the clamping arm 12 of the sheath 11 may be provided as a developing member, that is, the distal segment 111 and the clamping arm 12 are made of developing materials. The developing materials include but are not limited to stainless steel, cobalt-chromium alloy, and nickel-titanium alloy. During the operation, DSA or / and ultrasound may be used to determine whether the clamping portion 10 captures tissues such as the secondary septum 301 or the primary septum 302. When the secondary septum 301 or the primary septum 302 is captured, under the imaging device, there is an obvious gap between the clamping arm 12 and the sheath 11. When the secondary septum 301 or the primary septum 302 is not captured, there is no gap between the clamping arm 12 and the sheath 11. Of course, the first identification area 2313 and the second identification area 2314 may be added on this basis, and puncture may be performed on the premise of double confirmation that both tissues have been successfully captured, which further improves the puncture success rate and increases the suture success rate again.

[0082] In some embodiments, the movement of the first slider 24 requires the doctor to push the first control knob 210 to move distally in the slide hole 2311, so that the clamping arm 12 has a clamping force to clamp the secondary septum 301 or the primary septum 302, or to keep the clamping part 10 in a closed state during the intervention process. Fig.30 As shown, the first control rod 21 has a certain flexibility. If the clamping arm 12 captures the secondary septum 301 or the primary septum 302, and continues to push the first control knob 210 to move toward the distal end, the first control rod 21 can be bent and deformed, so that when the clamping arm 12 clamps the secondary septum 301 or the primary septum 302, the first control knob 210 has a certain amount of activity in the axial direction, so as to avoid the clamping arm 12 from clamping the secondary septum 301 or the primary septum 302 when the first control knob 210 is continuously pushed toward the distal end. If the clamping arm 12 does not capture the tissue, the first control knob 210 can be continuously pushed to move toward the distal end to ensure that the clamping portion 10 is closed.

[0083] Furthermore, if Fig.31As shown, in order to ensure that after the clamping part 10 captures the secondary septum 301 or the primary septum 302, the first control knob 210 is pushed to the farthest end of the sliding hole 2311, and the clamping part 10 is still not closed under the blocking effect of the secondary septum 301 or the primary septum 302, the first control rod 21 includes a flexible section 211 connected to the first slider 24 and a support section 212 connected to the distal end of the flexible section 211, the distal end of the support section 212 is hinged to the clamping arm 12, and the flexible section 211 is axially movable. The elastic deformation capacity of the flexible section 211 in the axial direction is greater than the elastic deformation capacity of the support section 212 in the axial direction. The flexible section 211 can be compressed in the axial direction through the elastic deformation of the flexible section 211, thereby ensuring that the clamping section 10 is not closed under the blocking action of the secondary septum 301 or the primary septum 302. Therefore, even after the clamping section 10 captures the primary septum or the secondary septum, the doctor pushes the first control knob 210 to the farthest end of the sliding hole 2311 due to misoperation, and the primary septum or the secondary septum will not be injured. The flexible section 211 can be a spring structure, or it can be spliced ​​with materials with good flexibility.

[0084] In some embodiments, please combine Fig. 9 and Fig.12 As shown, the handle 23 is provided with a stop wall 234 extending in the radial direction, and the stop wall 234 is provided between the first slider 24 and the second slider 25. The control part 20 also includes an elastic member 28. In the axial direction, the elastic member 28 is provided between the first slider 24 and the stop wall 234 and respectively abuts against the first slider 24 and the stop wall 234. The elastic member 28 applies an elastic force toward the distal end to the first slider 24. It can be imagined that in this embodiment, in the absence of external force, the elastic force applied by the elastic member 28 to the first slider 24 is transmitted to the clamping arm 12 through the first slider 24 and the first control rod 21, so that the clamping arm 12 and the distal segment 111 of the sheath 11 maintain a closed state. During the operation, the doctor needs to apply a pushing or pulling force toward the proximal side to the first control knob 210 to overcome the elastic force so that the first control knob 210 drives the first slider 24 and the first control rod 21 to move toward the proximal end, thereby opening the clamping portion 10 and placing the clamping portion 10 in an open state.

[0085] In some embodiments, when the first control knob 210 is located at the proximal end of the slide hole 2311, the elastic member 28 is in a compressed state, and when the first control knob 210 is located at the distal end of the slide hole 2311, the elastic member 28 is in a naturally stretched state.

[0086] In other embodiments, when the first control knob 210 is located at the distal end of the slide hole 2311, the elastic member 28 is still in a compressed state. Therefore, based on the elastic force of the elastic member 28, the first slider 24 has a tendency to slide toward the distal end, so that when the clamping portion 10 is in a closed state, there is a pre-tightening force between the clamping arm 12 and the sheath tube 11 to maintain closure.

[0087] It should also be noted that, by providing the elastic member 28, the elastic force exerted by the elastic member 28 causes the first slider 24 and the first control rod 21 to always maintain a tendency to move toward the distal end, so that the elastic member 28 can be used to actively detect whether the clamping portion 10 has successfully captured the primary septum or the secondary septum, and combined with the relative position relationship between the indicator needle 2101 and the first identification area 2313 and the second identification area 2314, the controllable doctor can intuitively judge whether the current state has captured the primary septum or the secondary septum.

[0088] Furthermore, if Fig.12 As shown, the stop wall 234 is provided with a guide hole 2341 passing through the proximal end and the distal end thereof, and the control unit 20 further includes a guide rod 29, which is slidably disposed in the guide hole 2341, and the distal end of the guide rod 29 is connected to the first slider 24, and the elastic member 28 is a compression spring, and the elastic member 28 is sleeved outside the guide rod 29. The guide rod 29 is provided to guide the direction of the elastic force applied by the compression spring to the first slider 24, thereby improving the smoothness of the sliding of the first slider 24 driven by the elastic force of the elastic member 28.

[0089] Furthermore, please combine Fig. 9 , Fig.11 , Fig.12 , Fig.13 and Fig.14 As shown, the first slider 24 is provided with a radially extending slide groove 243 at one end facing the first control knob 210, and the first control knob 210 is provided with a slide rail 2102 matched with the slide groove 243, and the slide rail 2102 is slidably arranged in the slide groove 243. The upper shell 231 of the handle 23 is also provided with a radially extending limiting hole 2312, one end of the limiting hole 2312 is connected to the proximal end of the slide hole 2311, and the extending direction of the limiting hole 2312 is perpendicular to the extending direction of the slide hole 2311. When the clamping portion 10 is in the open state, the first control knob 210 can be pushed to slide radially relative to the first slider 24, and the first control knob 210 can be pushed to slide radially relative to the first slider 24, and the first control knob 210 can be pushed to slide radially relative to the first slider 24. 0 moves into the limiting hole 2312, and the limiting hole 2312 is used to limit the sliding of the first control twist 210 in the axial direction, so that the clamping part 10 remains in the open state. Therefore, the first control twist 210 is used to cooperate with the limiting hole 2312 to lock the clamping part 10 in the open state. In the process of capturing the primary septum 302 or the secondary septum 301, it is only necessary to push the clamping part 10 to move along the axial direction of the sheath tube 11, so that the primary septum 302 or the secondary septum 301 can enter from the opening of the clamping part 10 to between the clamping arm 12 and the sheath tube 11, so as to simplify the capturing steps of the primary septum 302 or the secondary septum 301 and reduce the difficulty of the operation.

[0090] In some embodiments, please combine Fig.17 , Fig.18 , Fig.19 , Fig. 20 and Fig.23 As shown, the control part 20 also includes a limiting spring piece 26, which is a long plate-like structure. The limiting spring piece 26 includes a main board body 260 and a rotating connection part 264 arranged on the main board body 260. The rotating connection part 264 is a tubular structure. The rotating connection part 264 is hinged to the bottom wall 2301 of the lower shell 232 through a pin shaft. The main board body 260 can rotate around the rotating connection part 264 relative to the handle 23.

[0091] Please combine Fig.19 , Fig. 20 , Fig. 22 and Fig.23 As shown, in the direction from the distal end of the handle 23 to the proximal end of the handle 23, the main body 260 includes a first section 261, a second section 262 and a third section 263 connected in sequence, and the rotation connection portion 264 is provided in the area where the second section 262 and the third section 263 are connected. In the axial direction, the rotation connection portion 264 is located between the first slider 24 and the second slider 25. When the puncture needle 30 is located in the first channel (not shown in the figure) and the second slider 25 is located at the proximal position of the axial movement range of the second slider 25 (that is, the state in which the puncture needle 30 is stored in the sheath 11), the proximal end of the third section 263 is located between the rotation connection portion 264 and the distal end of the second slider 25 in the axial direction.

[0092] In the radial direction, the first section 261 and the second section 262 are located between the first slider 24 and the bottom wall 2301 of the handle 23. In the direction from the proximal end of the first section 261 to the distal end of the first section 261, the first section 261 is warped and bent toward the direction close to the first slider 24. When the first slider 24 moves from the proximal end of the handle 23 to the distal end of the handle 23, the first slider 24 successively slides and contacts with the plate surfaces of the second section 262 and the first section 261. Since the first section 261 is configured to be warped and bent toward the direction of the first slider 24, the first section 261 is pushed to rotate toward the direction close to the bottom wall 2301 during the movement of the first slider 24 toward the distal end of the handle 23, thereby driving the proximal end of the third section 263 to move away from the bottom wall 2301 and warp upward.

[0093] Specifically, Fig.19 As shown, in the open state, the first slider 24 abuts against the second section 262, and the proximal end of the third section 263 is located between the first slider 24 and the bottom wall 2301 of the lower shell 232 in the radial direction, so that the proximal end of the third section 263 is in a state of avoiding the second slider 25. At this time, when the second slider 25 is driven to move toward the distal end of the handle 23, the puncture needle 30 can be extended from the puncture port 1112 on the sheath 11 to perform the puncture and suturing action.

[0094] like Fig. 20As shown, in the closed state, the first slider 24 abuts against the first section 261, and the proximal end of the third section 263 tilts in the direction away from the bottom wall 2301, so that the proximal end position of the third section 263 is higher than the bottom of the second slider 25, and the proximal end of the third section 263 can abut against the distal end face of the second slider 25. When the second slider 25 is driven to move toward the distal end of the handle 23, the proximal end of the third section 263 abuts against the distal end of the second slider 25, thereby preventing the second slider 25 from continuing to move toward the distal end of the handle 23, preventing the puncture needle 30 from extending out of the puncture port 1112 on the sheath 11 when the clamping portion 10 is in the closed state, and preventing the clamping portion 10 from causing the puncture needle 30 to perform a puncture action without capturing the secondary septum 301 or the primary septum 302, thereby preventing the damage to the inner wall tissue of the heart.

[0095] In this embodiment, Fig.19 As shown, the bottom wall 2301 is provided with an arc-shaped protrusion arched toward the upper shell 231, and the rotating connecting portion 264 is correspondingly arranged at the arc top position of the arc-shaped protrusion, so that the main board body 260 has a larger rotation space.

[0096] In some embodiments, Fig.19 and Fig. 22 As shown, the middle area of ​​the second section 262 is concavely bent in the direction away from the first slider 24, that is, from the proximal end of the handle 23 to the distal end of the handle 23, the second section 262 is first bent in the direction away from the first slider 24 and then bent in the direction close to the first slider 24. When the first slider 24 abuts against the plate surface of the second section 262, that is, the clamping portion 10 is in the open state, the proximal end of the third section 263 can maintain a sufficient distance from the end of the second slider 25 facing the bottom wall 2301 in the radial direction, preventing the proximal end of the third section 263 from interfering with and hindering the second slider 25 from sliding toward the distal end of the handle 23 during the puncture action performed by the clamping portion 10 in the open state.

[0097] In some embodiments, Fig.24 As shown, the limiting spring piece 26 also includes an elastic section 265, which is connected to the first section 261. The elastic section 265 is bent in a direction away from the first slider 24 and abuts against the bottom wall 2301. Under the action of the elastic section 265 and the handle 23, when the first slider 24 abuts against the second section 262, the limiting spring piece 26 can keep the proximal end of the third section 263 away from the second slider 25. If the first slider 24 slides toward the distal end of the handle 23 and abuts against the first section 261, the elastic section 265 can be deformed and flattened under the pressure applied by the first slider 24, so that the limiting spring piece 26 rotates around the rotating shaft hole, and then the proximal end of the third section 263 is tilted in a direction away from the bottom wall 2301.

[0098] The structure of the elastic section 265 can be set in various forms. In some embodiments, for example Fig.24 , Fig.25 As shown, the elastic section 265 has the same plate width as the first section 261, and the elastic section 265 and the first section 261 form an angle less than 180° and greater than 90°. For example, the angle between the elastic section 265 and the first section 261 can be set to 100°, 110°, 120°, 130°, 140°, 150°, etc. In other embodiments, such as Fig.26 , Fig. 27 As shown, the elastic section 265 has the same plate width as the first section 261, and the angle between the elastic section 265 and the first section 261 is greater than or equal to 180°. For example, the angle between the elastic section 265 and the first section 261 can be set to 180°, 190°, etc. In other embodiments, such as Fig.28 , Fig.29 As shown, partial areas on both sides of the width of the first section 261 are cut and folded back 180° to form elastic sections 265 .

[0099] In other embodiments, Fig.18 , Fig.19 , Fig.23 As shown, the elastic section 265 is not provided on the limiting spring piece 26, but the elastic section 265 is replaced by a torsion spring 27. Specifically, the limiting spring piece 26 is provided with a mounting hole 266, and the control part 20 further includes a torsion spring 27, which is mounted on the rotating connection part 264, and one of the rotating arms 271 of the torsion spring 27 abuts against the stop wall 234, and the other rotating arm 271 of the torsion spring 27 abuts against the third section 263, and the torsion spring 27 applies an elastic force to the limiting spring piece 26 to drive the proximal end of the third section 263 to rotate toward the bottom wall 2301. Under the action of the torsion spring 27, the limiting spring piece 26 maintains the stress of clockwise rotation, and if there is no intervention of the first slider 24 (that is, when the first slider 24 is located at the proximal end so that the clamping part 10 is in an open state), the limiting spring piece 26 maintains a state where the proximal end is low and the distal end is high, so that the proximal end of the third section 263 avoids the second slider 25.

[0100] For details, please refer to Fig.19 As shown, when the clamping portion 10 is in an open state, the first slider 24 is located at the proximal position and abuts against the second section 262, and the clamping portion 10 is in an open state, which also indicates that the clamping arm 12 and the sheath 11 have captured the secondary septum 301 or the primary septum 302. At this time, the suturing conditions are met, and the proximal end of the limiting spring piece 26 does not interfere with the second slider 25 of the needle. The second slider 25 can slide toward the distal end of the handle 23, that is, the puncture needle 30 is allowed to be removed for suturing.

[0101] Please refer to Fig. 20As shown, the clamping part 10 is in a closed state, the first slider 24 is at the distal position and abuts against the first section 261, indicating that the clamping arm 12 and the sheath tube 11 have not captured the secondary septum 301 or the primary septum 302, and the suturing conditions are not met. The distal end of the limiting spring piece 26 rotates counterclockwise around the pin shaft under the action of the first slider 24, and the proximal end of the limiting spring piece 26 is lifted and interferes with the second slider 25. The second slider 25 cannot move toward the distal end of the handle 23, and the puncture needle 30 cannot perform the puncture action, thereby avoiding suturing failure caused by misoperation.

[0102] Furthermore, if Fig. 20 and Fig.21 As shown, the end of the first slider 24 facing the limiting spring sheet 26 is provided with a sliding portion 241 protruding toward the limiting spring sheet 26, and the outer contour of the sliding portion 241 is set as an arc-shaped curved surface. Among them, the sliding portion 241 can also be set as a hemispherical structure, the purpose is to reduce the contact area between the first slider 24 and the limiting spring sheet 26, thereby reducing the resistance during the sliding process. Accordingly, the sliding portion 241 can be selected from a self-lubricating material, such as POM (Polyoxymethylene, polyoxymethylene), PTFE (Polytetrafluoroethylene, polytetrafluoroethylene), etc.

[0103] The patent foramen ovale suture device 100 proposed in this embodiment has the following advantages: a clamping arm 12 and a first control knob 210 are provided, which can assist the doctor in determining whether the suturing conditions are met before the puncture needle 30 is sutured, thereby simplifying the surgical operation and increasing the suturing success rate; the clamping arm 12 is in planar contact with the secondary septum 301 or the primary septum 302, and the contact surface is flat, thereby avoiding stress concentration, reducing the probability of damaging the secondary septum 301 or the primary septum 302 tissue, penetrating the secondary septum 301 or the primary septum 302 tissue, and failing to detect due to penetrating the secondary septum 301 or the primary septum 302 tissue; the capture status of the clamping part 10 is identified through DSA, ultrasonic equipment, handle 23 identification and other schemes, which has selection flexibility, simple and reliable identification, and also reduces the learning route of doctors; the clamping arm 12 is driven by the elastic member 28, which has a simple structure, simple operation, high sensitivity of the detection system, and avoids erroneous judgment caused by delay; an operating system is provided to prevent the puncture needle 30 from misoperating, which can avoid improper operation and cause suturing failure, thereby improving the success rate of the operation.

[0104] According to an embodiment of the present invention, a patent foramen ovale suture system is also provided. Figure 1a , Figure 1b and Figure 3a , Figure 3bAs shown, the patent foramen ovale suture system includes two patent foramen ovale suture instruments 100, wherein the clamping portion 10 of one of the patent foramen ovale suture instruments 100 is opened at the distal end in the open state and is used to capture the secondary septum 301, and the clamping portion 10 of the other patent foramen ovale suture instrument 100 is opened at the proximal end in the open state and is used to capture the primary septum 302.

[0105] Specifically, the second hinged portion 122 of one of the two patent foramen ovale suture devices 100 is located between the free end 1202 and the first hinged portion 121, and the hinged position of the first hinged portion 121 and the sheath 11 is located at the proximal end of the accommodating groove 1111, such as Figure 3a and Figure 5 The patent foramen ovale suture device 100 with the distal end of the clamping portion 10 opened is a suture device used to capture the septum secundum 301 and to thread a first suture line on the septum secundum 301 .

[0106] The first hinged portion 121 of the other one of the two patent foramen ovale suture devices 100 is located between the free end 1202 and the second hinged portion 122, and the hinged position of the first hinged portion 121 and the sheath tube 11 is located at the distal end of the accommodating groove 1111, as shown in FIG. Figure 3b and Figure 4 The patent foramen ovale suture device 100 with the proximal opening of the clamping portion 10 is a suture device for capturing the primary septum 302 and threading a second suture line on the primary septum 302 .

[0107] It should also be noted that after completing the operation of inserting the first suture and the second suture on the secondary septum 301 and the primary septum 302 respectively, it is necessary to select a suture locking device of appropriate type according to needs, and use the suture locking device to capture the first suture and the second suture and tighten and lock the two together to bring the secondary septum 301 and the primary septum 302 closer, so as to facilitate the subsequent fusion of the secondary septum 301 and the primary septum 302 to close the foramen ovale.

[0108] 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. A patent foramen ovale suture device, characterized in that: The patent foramen ovale suture device comprises a puncture needle, a control part and a clamping part which can be opened and closed in radial direction, the clamping part comprises a sheath tube and a clamping arm, the clamping arm is hinged to the sheath tube, the control part comprises a first control rod and a second control rod, the first control rod can be movably arranged in the sheath tube, the distal end of the first control rod is hinged to the clamping arm and can control the clamping arm and the sheath tube to switch between a closed state and an open state, the second control rod can be movably arranged in the sheath tube, the distal end of the second control rod is connected to the puncture needle and can drive the puncture needle to move relative to the clamping arm, so as to drive the puncture needle to cooperate with the clamping arm in the open state to puncture and pass the suture thread through the primary septum or the secondary septum; The control unit also includes: A handle, the proximal end of the sheath is connected to the handle; A first slider is slidably disposed on the handle along the axial direction, and the proximal end of the first control rod is connected to the first slider; A second slider is slidably disposed on the handle along the axial direction, and a proximal end of the second control rod is connected to the second slider; The second sliding block is arranged closer to the proximal end of the handle than the first sliding block; The control part further includes a limiting spring piece, and in the direction from the distal end of the handle to the proximal end of the handle, the limiting spring piece includes a first section, a second section, a rotation connection section and a third section which are connected in sequence, and the rotation connection section is located between the first slider and the second slider and is hinged to the bottom wall of the handle; Along the radial direction, the first section and the second section are located between the first slider and the bottom wall of the handle, and the first section is warped and bent toward a direction close to the first slider; Among them, in the open state, the first slider is against the second section, and the proximal end of the third section avoids the second slider. In the closed state, the first slider is against the first section, and the proximal end of the third section can be against the distal end face of the second slider.

2. The patent foramen ovale suture device according to claim 1, characterized in that: The limiting spring sheet further includes an elastic section, the elastic section is connected to the first section, the elastic section is bent in a direction away from the first sliding block and abuts against the bottom wall of the handle.

3. The patent foramen ovale suture device according to claim 1, characterized in that: The limiting spring piece is provided with a mounting hole, and the control part also includes a torsion spring, which is installed on the rotating connection part and the spiral arm of the torsion spring is passed through the mounting hole and abutted against the handle, and the torsion spring applies an elastic force to the limiting spring piece to drive the proximal end of the third section to rotate toward the bottom wall of the handle.

4. The patent foramen ovale suture device according to claim 1, characterized in that: One end of the first sliding block facing the limiting spring piece is provided with a sliding portion protruding toward the limiting spring piece, and the outer contour of the sliding portion is set to be an arc-shaped curved surface.

5. The patent foramen ovale suture device according to claim 1, characterized in that: A stop wall extending along the radial direction is provided inside the handle, the first slider is arranged closer to the distal end of the handle than the stop wall, and the second slider is arranged closer to the proximal end of the handle than the stop wall; The control part also includes an elastic member, which is arranged between the first slider and the stop wall along the axial direction and is respectively connected to the first slider and the second slider, and the elastic member applies an elastic force toward the distal end of the handle to the first slider.

6. The patent foramen ovale suture device according to claim 5, characterized in that: The stop wall is provided with a guide hole which passes through the proximal end and the distal end of the stop wall. The control part also includes a guide rod which is slidably inserted into the guide hole. The distal end of the guide rod is connected to the first slider. The elastic member is sleeved outside the guide rod.

7. The patent foramen ovale suture device according to claim 1, characterized in that: The first control rod includes a flexible section connected to the first slider and a support section connected to the distal end of the flexible section, the distal end of the support section is hinged to the clamping arm, and the elastic deformation capacity of the flexible section along the axial direction is greater than the elastic deformation capacity of the support section along the axial direction.

8. A patent foramen ovale suture system, characterized in that: The patent foramen ovale suturing system comprises two patent foramen ovale suturing devices according to any one of claims 1 to 7, wherein the clamping arms of the patent foramen ovale suturing devices are provided with a first hinged portion and a second hinged portion which are spaced apart, the first hinged portion is hinged to the sheath, and the distal end of the first control rod is hinged to the second hinged portion; The clamping arm has a connection end connected to the sheath tube and a free end not connected to the sheath tube; The first hinged portion of one of the two patent foramen ovale suture devices is located between the free end and the second hinged portion and is used to capture the primary septum, and the second hinged portion of the other patent foramen ovale suture device is located between the free end and the first hinged portion and is used to capture the secondary septum.

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