First stapling instrument and stapling system

Abstract

The utility model provides a first suturing instrument and a suturing system.The first suturing instrument comprises a conveying catheter, a fixing piece, a push rod, a puncture needle and an anchoring piece, the fixing piece is connected to the far end of the conveying catheter, an opening and closing arm used for bearing tissue is installed on the fixing piece, and a needle outlet hole used for the puncture needle to penetrate out is formed in the fixing piece; a first hole for a puncture needle to penetrate through is formed in the opening and closing arm; the push rod is arranged in the conveying catheter, is connected with the opening and closing arm and is used for opening or closing the opening and closing arm; the puncture needle is arranged in the conveying catheter; the anchoring piece is arranged at the far end of the puncture needle or connected with the far end of the puncture needle, and a suture is fixedly connected into the anchoring piece. According to the suture instrument, by arranging the conveying catheter, the fixing piece, the push rod, the puncture needle and the anchoring piece connected with the suture, the suture can be easily anchored to the tissue, and the technical problem that the suture instrument cannot anchor the suture to the tissue easily is solved.

Description

Technical Field

[0001] The present application belongs to the technical field of medical devices, and specifically, relates to a first suturing device and a suturing system. Background Art

[0002] This section merely provides background information related to the present disclosure and is not necessarily prior art.

[0003] Patent foramen ovale is currently the most common congenital heart abnormality in adults, accounting for about 20%-25%. Many studies in recent years have shown that there is a close connection between patent foramen ovale and patients with unexplained stroke. This is because through the patent foramen ovale, the following emboli can enter the left heart system and cause corresponding clinical symptoms: ① thrombosis in the deep veins of the lower limbs or pelvic veins; ② air emboli caused by decompression sickness or decompression sickness; ③ fat emboli formed after surgery or trauma.

[0004] The existing method for treating the above-mentioned disease is to use occlusion surgery to place a larger metal atrial septal defect occluder at the patent foramen ovale. The above-mentioned occluder is usually large in size and cannot be decomposed or absorbed by the body. In addition, due to the complex structure of the heart, placing the occluder in the heart may increase the risk of complications in the short or long term. Other existing methods for suturing the patent foramen ovale include a tissue suturing device via a catheter approach, which sews the suture to the primary septum or secondary septum of the foramen ovale, mainly by fixing one end of the suture on the deployment arm, and then driving the puncture needle through the tissue to successfully hook one end of the suture on the deployment arm, and then withdrawing the puncture needle, and then withdrawing the suture with the puncture needle, and anchoring the suture to the tissue. However, the device requires the puncture needle to hook the suture on the deployment arm, and the hooking accuracy of the puncture needle is extremely high. It is easy to have the risk of failing to successfully hook one end of the suture on the deployment arm, resulting in the inability to anchor the suture to the tissue. Utility Model Content

[0005] The present application provides a first suturing instrument and a suturing system, which at least solve the technical problem that the suturing instruments in the prior art are prone to being unable to anchor the suture thread to the tissue.

[0006] In a first aspect, a first suturing device is provided, comprising a delivery catheter, a fixing member, a push rod, a puncture needle and an anchor member, wherein the fixing member is connected to the distal end of the delivery catheter, an opening and closing arm for supporting tissue is installed on the fixing member, a needle exit hole for the puncture needle to pass through is provided on the fixing member, and a first hole for the puncture needle to pass through is provided on the opening and closing arm; the push rod is arranged in the delivery catheter, the push rod is connected to the opening and closing arm, and the push rod is used to open or close the opening and closing arm; the puncture needle is arranged in the delivery catheter; the anchor member is arranged at the distal end of the puncture needle or connected to the distal end of the puncture needle, and a suture is fixedly connected in the anchor member.

[0007] In a second aspect, a suture system is further provided, which includes a first suture instrument and a second suture instrument. The second suture instrument includes a second puncture needle and a puncture tube arranged side by side with the second puncture needle. A needle connecting member is fixed to the distal ends of the second puncture needle and the puncture tube. The second suture instrument further includes a second opening and closing arm, and a second hole for the second puncture needle to pass through is formed in the second opening and closing arm. The opening direction of the second opening and closing arm is opposite to that of the opening and closing arm of the first suture instrument. The second suture instrument further includes a second anchoring member disposed inside the distal end of the second puncture needle. The second suture instrument further includes a second control rod and a guiding rod arranged side by side with the second control rod. The guiding rod is disposed inside the puncture tube and is movable relative to the puncture tube. The second control rod is disposed inside the second puncture needle and is movable relative to the second puncture needle. The second control rod is used to separate the second anchoring member from the second puncture needle. A rod connecting member is fixed to the distal ends of the second control rod and the guiding rod.

[0008] With respect to the first suture instrument and the suture system of the present application, by providing a delivery catheter, a fixing member, a push rod, a puncture needle, and an anchoring member connected with a suture, as long as the puncture needle can puncture the opening and closing arm, the anchoring member and the suture can be fixed to the opening and closing arm, and then the suture can be anchored to the tissue, avoiding the technical problem that the existing suture instrument is prone to failure to anchor the suture to the tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the background art, the drawings required to be used in the embodiments of the present application or the background art will be described below.

[0010] Figure 1a Schematic structural diagram of the opening of the opening and closing arm of the first suture instrument in an embodiment of the present application;

[0011] Figure 1b Schematic structural diagram of the closing of the opening and closing arm of the first suture instrument in an embodiment of the present application;

[0012] Figure 1c Schematic diagram of the puncture needle of the first suture instrument passing out of the delivery catheter in an embodiment of the present application;

[0013] Figure 1d Schematic structural diagram of the puncture needle of the first suture instrument penetrating into the opening and closing arm in an embodiment of the present application;

[0014] Figure 2 Schematic sectional structural diagram of the first suture instrument in an embodiment of the present application;

[0015] Figure 3Schematic enlarged view of the opening and closing arm in an embodiment of the present application;

[0016] Figure 4 Schematic exploded view of the first suture instrument in an embodiment of the present application;

[0017] Figure 5 Schematic exploded view of the puncture needle, the anchor and the control rod in an embodiment of the present application;

[0018] Figure 6a Schematic view of the control rod and the anchor located inside the puncture needle in an embodiment of the present application;

[0019] Figure 6b Schematic view of the anchor being pushed out of the puncture needle by the control rod in an embodiment of the present application;

[0020] Figure 7a Schematic view of the puncture needle entering the opening and closing arm after puncturing the tissue in an embodiment of the present application;

[0021] Figure 7b Schematic view of the anchor being pushed out after the puncture needle has completed puncturing in an embodiment of the present application;

[0022] Figure 7c Schematic view of the puncture needle being withdrawn after the puncture needle has completed puncturing in an embodiment of the present application;

[0023] Figure 8 Schematic view of the anchor and the suture being limited in the opening and closing arm in an embodiment of the present application;

[0024] Figure 9 Schematic view of the first suture instrument entering the heart in an embodiment of the present application;

[0025] Figure 10a - 10d Illustrates the use process of the first suture instrument suturing the suture to the primary septum;

[0026] Figure 11 Schematic view of the puncture needle in an embodiment of the present application;

[0027] Figure 12a - 12c Schematic view of the puncture needle, the anchor and the control rod in an embodiment of the present application;

[0028] Figure 13a - 13c Schematic view of the puncture needle, the anchor and the control rod in another embodiment of the present application;

[0029] Figure 14a - 14d Schematic process view of the first suture instrument suturing the suture to the primary septum when both free ends of the suture are fixed inside the anchor in an embodiment of the present application;

[0030] Figure 15a - 15cSchematic diagram of the opening and closing arm in an embodiment of the present application;

[0031] Figure 15d - 15e Schematic diagram of the anchoring piece in an embodiment of the present application;

[0032] Figure 16a - 16b Schematic diagram of the opening and closing arm with a protective film in an embodiment of the present application;

[0033] Figure 17a Schematic diagram of the first hole of the opening and closing arm being a through hole in an embodiment of the present application;

[0034] Figure 17b Schematic diagram of the suture being fixed to the primary septum when the first hole of the opening and closing arm is a through hole;

[0035] Figure 18a Schematic diagram of the opening and closing arm in an embodiment of the present application;

[0036] Figure 18b Schematic diagram of the opening and closing arm, the anchoring piece and the puncture needle in an embodiment of the present application;

[0037] Figure 18c For Figure 18b Partial sectional structure schematic diagram;

[0038] Figure 18d Schematic diagram of the elastic member in an embodiment of the present application;

[0039] Figure 18e Schematic diagram of the anchoring piece penetrating into the opening and closing arm in an embodiment of the present application;

[0040] Figure 18f - 18g Schematic diagram of the anchoring piece in an embodiment of the present application;

[0041] Figure 18h - 18i Schematic diagram of the elastic member in an embodiment of the present application;

[0042] Figure 19a Schematic diagram of the second suturing instrument in a state of the suturing system of the present application;

[0043] Figure 19b Schematic diagram of the second suturing instrument in another state of the suturing system of the present application;

[0044] Figure 20a - 20c Illustrates the use process of the second suturing instrument suturing the suture to the secondary septum;

[0045] Figure 20d Schematic diagram illustrating the structure for suturing the unclosed patent foramen ovale.

[0046] The reference signs in the drawings are as follows:

[0047] 1. First suture instrument; 10. Opening and closing arm; 11. First hole; 111. Puncture hole; 112. Clamping hole; 113. Reverse hole; 114. Straight hole; 115. Through hole; 12. Installation groove; 13. Anchor piece; 14. Upper surface; 15. Lower surface; 16. Side surface; 17. Protective film; 18. Elastic member; 181. Limit hole; 1811. Inner hole; 1812. Outer hole; 1813. Convex tooth; 182. Crack; 19. Limit groove; 20. Puncture needle; 21. Fourth S buckle; 30. Fixing member; 31. Needle outlet hole; 32. Depressed part; 40. Push rod; 50. Anchor member; 51. First S buckle; 52. Third S buckle; 53. Taper section; 54. Waist section; 55. Limit section; 56. Connection section; 60. Delivery catheter; 70. Control rod; 71. Second S buckle; 91. Suture; 2. Primary septum; 3. Secondary septum; 4. Left atrium; 5. Left ventricle; 6. Right atrium; 7. Right ventricle. 8. Second suture instrument; 81. Second puncture needle; 82. Puncture tube; 83. Needle connecting piece; 84. Second opening and closing arm; 85. Second hole; 86. Second control rod; 87. Guide rod; 88. Rod connecting piece. Detailed implementation manners

[0048] The exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided so that the present disclosure can be more thoroughly understood and the scope of the present disclosure can be fully conveyed to those skilled in the art.

[0049] It should be understood that the terms used herein are only for the purpose of describing specific exemplary embodiments and are not intended to be limiting. Unless otherwise clearly indicated in the context, the singular forms "a", "an" and "the" as used herein may also include the plural forms. The terms "include", "comprise", "contain" and "have" are inclusive and thus specify the presence of the stated features, steps, operations, elements and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof.

[0050] Although the terms first, second, third, etc. may be used herein 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 may be used only to distinguish one element, component, region, layer, or section from another region, layer, or section. Unless the context clearly indicates otherwise, terms such as "first", "second", and other numerical terms do not imply an order or sequence when used in the text. Thus, the first element, component, region, layer, or section discussed below may be referred to as the second element, component, region, layer, or section without departing from the teachings of the exemplary embodiments.

[0051] For ease of description, spatial relative relationship terms may be used herein to describe the relationship of one element or feature shown in the figure to another element or feature, such relative relationship terms being, for example, "inside", "outside", "inner side", "outer side", "below", "beneath", "above", "over", etc. Such spatial relative relationship terms are intended to include different orientations of the device in use or operation other than the orientation depicted in the figure. For example, if the device in the figure is flipped, an element described as "below" or "beneath" another element or feature will then be oriented as "above" or "over" the other element or feature. Thus, the exemplary term "below" can include both upward and downward orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatial relative relationship descriptors used in the text are to be interpreted accordingly.

[0052] It should be noted that the terms "distal end" and "proximal end" are commonly used terms in the field of medical devices. The "distal end" refers to the end that is far from the operator during the surgical procedure, and the "proximal end" refers to the end that is close to the operator during the surgical procedure. The axial direction refers to the direction parallel to the line connecting the centers of the distal end and the proximal end of the medical device; the radial direction refers to the direction perpendicular to the above-mentioned axial direction.

[0053] Please refer to Figures 1a to 10d, the first suture instrument 1 of the present application is used for suturing the unclosed foramen ovale. The first suture instrument 1 includes a delivery catheter 60, a fixing member 30, a push rod 40, a puncture needle 20, and an anchoring member 50. The fixing member 30 is connected to the distal end of the delivery catheter 60. An opening and closing arm 10 for supporting tissue is installed on the fixing member 30. A needle outlet hole 31 for the puncture needle 20 to pass through is formed on the fixing member 30. A first hole 11 for the puncture needle 20 to pass through is formed on the opening and closing arm 10; the push rod is arranged in the delivery catheter 60, the push rod 40 is connected to the opening and closing arm 10, and the push rod 40 is used to open or close the opening and closing arm 10; the puncture needle 20 is arranged in the delivery catheter 60; the anchoring member 50 is arranged at the distal end of the puncture needle 20 or the anchoring member 50 is connected to the distal end of the puncture needle 20, and a suture 91 is fixedly connected in the anchoring member 50.

[0054] Specifically, a conical head may be provided at the distal end of the fixing member 30. The diameter of the conical head gradually decreases from the proximal end to the distal end, which helps the first suture instrument 1 to have better guiding effect and adaptability when entering the human body and is not easy to cause damage to tissues. The conical head can be doped with a certain amount of barium sulfate in the manufacturing process to be visible under ultrasound and make it more convenient to view the position of the first suture instrument 1 in the body during the operation. The delivery catheter 60 has a certain length and a certain flexibility, so that it can enter the heart through the femoral artery, femoral vein or other paths. In order to make the puncture and suturing process of the first suture instrument 1 more stable and the puncture position more accurate, the fixing member 30 can be made of a metal material. The connection method between the fixing member 30 and the delivery catheter 60 can be by fusion welding, soldering, hinged connection, pin connection, interference connection, convex groove cooperation, etc. There is no strict limitation on its connection method, as long as the fixing member 30 can be fixedly connected to the distal end of the delivery catheter 60. After the first suture instrument 1 enters the human body and reaches the target position, that is, after entering the foramen ovale position, the opening and closing arm 10 is opened by controlling the push rod 40. The specific way to control the push rod 40 can be through a handle, that is, a handle can be provided at the proximal end of the first suture instrument 1. After the opening and closing arm 10 is opened, one of the secondary septum 3 or the primary septum 2 is limited, such as Figures 10a to 10dShown is that the primary septum 2 is limited, and the opening and closing arm 10 has a certain supporting effect on the primary septum 2. Then, the puncture needle 20 is controlled to pass through the primary septum 2 (as shown in 10b) and enter the first hole 11 of the opening and closing arm 10. After the puncture needle 20 exits from the first hole 11, since the anchor 50 and the suture 91 will move out of the first hole 11 together with the puncture needle 20, then the puncture needle 20 is withdrawn proximally. When the puncture needle 20 is withdrawn, one end of the anchor 50 and the suture 91 remains on the opening and closing arm 10 or directly on the primary septum 2. After one end of the anchor 50 and the suture 91 remains on the opening and closing arm 10, the opening and closing arm 10 is withdrawn from the primary septum 2 and then closed, and then the first suture instrument 1 as a whole is slowly withdrawn from the body. During the withdrawal process, one end of the anchor 50 and the suture 91 is always arranged on the opening and closing arm 10. After the withdrawal is completed, one suture 91 is anchored to the primary septum 2. Subsequently, the secondary septum 3 can be sutured again, and one suture is also anchored to the secondary septum 3. Finally, the primary septum 2 and the secondary septum 3 are sutured by using a knotter to complete the closure of the patent foramen ovale. By this way of anchoring the suture 91 to the tissue, it is simple, stable and reliable, and has low alignment requirements for the puncture needle 20. It only requires the puncture needle 20 to be able to puncture the opening and closing arm 10, and does not require the puncture needle 20 to hook or grab any components on the opening and closing arm 10, improving the suture success rate.

[0055] Among them, one free end of the suture 91 can be fixedly connected inside the anchor 50, or two free ends of the suture 91 can be fixedly connected. The anchor 50 and the suture 91 can be fixedly connected by welding, cementing, fusing, tying a knot, etc. There is no strict limitation on its fixing method, as long as the fixed connection can be achieved.

[0056] In an embodiment of the first suture instrument 1 of the present application, the first suture instrument 1 further includes a control rod 70. The control rod 70 is arranged inside the puncture needle 20, and the control rod 70 is used to separate the anchor 50 from the puncture needle 20. Among them, the anchor 50 is arranged at the distal end inside the puncture needle 20, and the control rod 70 can move relative to the puncture needle 20. The control rod 70 is used to eject the anchor 50 from the puncture needle 20. Please refer to Figure 1b and Figure 9 The opening and closing arm 10 is in a closed state. In order to avoid scratching the tissue during the process of the first suture instrument 1 penetrating into the human body, the opening and closing arm 10 is in a closed state during this process. After the first suture instrument 1 reaches the target position, please refer to Figure 2 , the push rod 40 is movably connected to the opening and closing arm 10. During the process of controlling the movement of the push rod 40, the opening and closing arm 10 can rotate around the pin, and thus the opening and closing arm 10 can be opened or closed. Please refer to Figure 1a and Figure 10a, by controlling the push rod 40, the opening and closing arm 10 is opened. In the figure, the primary septum 2 is shown to be placed between the opening and closing arm 10 and the fixing member 30. After the position is determined, the puncture needle 20 is controlled to penetrate the opening and closing arm 10 as Figure 10b shown. Before penetrating the opening and closing arm 10, it also penetrates the primary septum 2, Figure 1c and Figure 1d only roughly shows the movement process of the puncture needle 20, and does not show the tissue (here the tissue can refer to the primary septum or the secondary septum or any human tissue that needs to be sutured with a suture). Please refer to Figures 4 to 7c , since one end of the suture 91 is fixed in the anchor 50, and the anchor 50 is arranged inside the distal end of the puncture needle 20. In order to prevent the anchor 50 from moving randomly inside the puncture needle 20, the anchor 50 can be temporarily fixed at the distal end inside the puncture needle 20 by means of an interference fit between the anchor 50 and the puncture needle 20. Although the anchor 50 is fixed at the distal end inside the puncture needle 20, the anchor 50 can still be ejected from the puncture needle 20 under the action of the control rod 70. Please refer to Figure 8 , the first hole 11 on the opening and closing arm 10 is a stepped hole. The stepped hole includes a puncture hole 111 and a clamping hole 112. The aperture of the clamping hole 112 is larger than the aperture of the puncture hole 111. Please refer to Figure 6b 、 7b and 10b. After the puncture needle 20 penetrates through the opening and closing arm 10, the anchor 50 and the suture 91 are ejected from the puncture needle 20 under the action of the control rod 70. After ejection, the puncture needle 20 is withdrawn. Please continue to refer to Figure 10c 、 7b -7c. When the puncture needle 20 is withdrawn, since the anchor 50 and the suture 91 are stuck in the stepped hole, in order to better limit the anchor 50 inside the opening and closing arm 10, the anchor 50 is stuck in the clamping hole 112, and the aperture of the puncture hole 111 is larger than the outer diameter of the puncture needle 20. In this way, the puncture needle 20 can smoothly penetrate through the opening and closing arm 10. At the same time, the aperture of the puncture hole 111 is smaller than the length of the anchor 50. In this way, the anchor 50 can be stuck on the opening and closing arm 10 and will not be withdrawn with the puncture needle 20. At the same time, because the anchor 50 and the suture 91 are ejected from the puncture needle 20 by the control rod 70, due to the forces in various directions such as gravity and the pulling of the suture 91, the anchor 50 will not maintain a direction parallel to the puncture needle 20, but will become as Figure 6b 、 7bThe states of the anchor 7c, so that when the puncture needle 20 is withdrawn, the anchor 50 and the suture 91 are limited within the stepped hole of the opening and closing arm 10. One end of the suture 91 is fixed within the anchor 50, and the other end of the suture 91 can be disposed within the delivery catheter 60 and can extend all the way to the handle of the first suturing instrument 1. A coil can be provided on the handle of the first suturing instrument 1, and the other end of the suture 91 can be disposed within the coil. After the puncture needle 20 is withdrawn, then the opening and closing arm 10 is slowly separated from the primary septum 2. After separation, the opening and closing arm 10 can be closed, and then the entire first suturing instrument 1 is slowly withdrawn. Since one end of the suture 91 has been on the opening and closing arm 10 all the time, when the first suturing instrument 1 is withdrawn outward, the portion of the suture 91 within the delivery catheter 60 continuously slides off the primary septum 2, so that the first suturing instrument 1 can smoothly withdraw the suture 91 on the opening and closing arm 10 from the body. After the first suturing instrument 1 is withdrawn from the body, the U-shaped end of one suture 91 is left on the primary septum 2 (such as Figure 10d ).

[0057] In one or more embodiments of the present application, please refer to Figure 11 , during the pushing process of the puncture needle 20, when the puncture needle 20 penetrates out of the needle outlet hole 31, a certain slope is provided within the needle outlet hole 31. In this way, after the puncture needle 20 penetrates out of the needle outlet hole 31, it can puncture towards the opening and closing arm 10. When the puncture needle 20 passes through the slope within the needle outlet hole 31, under the action of the slope, the puncture needle 20 has a certain deflection. In order to reduce the pushing resistance of the puncture needle 20, a flexible section can be added to the distal end of the puncture needle 20, that is, the puncture needle 20 is generally still a rigid structure, and only a flexible section is added to the distal end of the puncture needle 20. This flexible section can be processed by a material removal processing method. For example, laser cutting can be used at the distal end of the puncture needle 20 to machine spiral grooves on the surface so that a part of the puncture needle 20 is flexible. Of course, different pitches can also be set to achieve different hardnesses of the puncture needle 20, or it can be composed of a rigid puncture needle and a flexible material spliced together.

[0058] In one embodiment, please refer to Figures 12a to 12c, the anchor 50 is provided at the distal end of the puncture needle 20. A first S-shaped buckle 51 is formed at the proximal end of the anchor 50, and a second S-shaped buckle 71 that cooperates with the first S-shaped buckle 51 is formed at the distal end of the control rod 70. The control rod 70 is used to separate the anchor 50 from the puncture needle 20. One end of the suture 91 remains fixed within the anchor 50. The anchor 50 and the control rod 70 are disposed within the puncture needle 20. When the puncture needle 20 passes through the tissue and the opening and closing arm 10 and extends out from the opening and closing arm 10, the puncture needle 20 remains stationary. Then, continue to push the control rod 70 to move distally to push the anchor 50 out of the puncture needle 20, thereby limiting the anchor 50 and the suture 91 within the first hole 11 of the opening and closing arm 10. Then, withdraw the puncture needle 20 and the control rod 70 within the puncture needle 20. Of course, the anchor 50 can also be disengaged from the puncture needle 20 in another way. When the puncture needle 20 exits from the first hole 11 of the opening and closing arm 10, the puncture needle 20 can be slowly withdrawn. When the distal end of the puncture needle 20 is withdrawn to the distal end of the control rod 70, at this time, the anchor 50 is no longer within the puncture needle 20, and thus the first S-shaped buckle 51 and the second S-shaped buckle 71 are disengaged from each other automatically, that is, the anchor 50 and the control rod 70 are disengaged from each other. After the anchor 50 is disengaged from the puncture needle 20, continue to withdraw the puncture needle 20 to limit the anchor 50 and the suture 91 within the first hole 11 of the opening and closing arm 10. In this embodiment, the distal end of the anchor 50 is provided with a tip, and the taper of the distal end of the puncture needle 20 is the same as the taper of the tip of the anchor 50 to improve the puncture effect of the puncture needle 20.

[0059] In one or more embodiments, please refer to Figures 13a to 13c , the proximal end of the anchor 50 is connected to the distal end of the puncture needle 20. The distal end of the anchor 50 is provided with a pointed tip for puncturing tissue. A third S-shaped buckle 52 is formed at the proximal end of the anchor 50, and a fourth S-shaped buckle 21 that cooperates with the third S-shaped buckle 52 is formed at the distal end of the puncture needle 20. The control rod 70 can slide relative to the anchor 50 and the puncture needle 20. Here, the tissue can refer to the primary septum or the secondary septum or any human tissue that needs to be sutured with a suture. Specifically, the pointed tip of the anchor 50 can be understood as being similar to the needle tip of the puncture needle 20 in other embodiments. In this embodiment, the anchor 50, the puncture needle 20, and the control rod 70 pass through the tissue and the opening and closing arm 10 together and extend out from the opening and closing arm 10. Then, by controlling the control rod 70, the control rod 70 is withdrawn proximally, so that the third S-shaped buckle 52 and the fourth S-shaped buckle 21 are disengaged from each other, thereby separating the anchor 50 from the puncture needle 20. Then, withdraw the puncture needle 20 again, so that the anchor 50 and the suture 91 are limited within the first hole 11 of the opening and closing arm 10.

[0060] In another embodiment, please refer to Figures 14a to 14d, the suture 91 can be folded in half and both free ends of the suture 91 can be fixed to the anchor 50. The U-shaped end of the suture 91 is pre-installed in the delivery catheter 60, and the rest is the same as the above-described embodiment. After puncturing the tissue, two strands of suture 91 will be left on the tissue. The suture 91 left outside the body is two free ends and a U-shaped end. The two free ends can be bypassed around the U-shaped end, and then the two free ends are pulled, so that the U-shaped end is tightened and finally fixed to the tissue along the surgical access path, as Figure 14d shown.

[0061] In one or more embodiments of the present application, please refer to Figures 15a to 15e , in order to increase the stability of the anchor 50 limited to the opening and closing arm 10 and further prevent the anchor 50 from coming out of the first hole 11 of the opening and closing arm 10, an installation groove 12 can be provided on the opening and closing arm 10, and an anchor piece 13 is fixedly provided in the installation groove 12. The installation groove 12 is located between the puncture hole 111 and the clamping hole 112. The anchor piece 13 is made of a material with a certain elasticity. When the puncture needle 20 passes through the anchor piece 13, the hole on the anchor piece 13 expands to allow the puncture needle 20 to pass through. After the anchor 50 is separated from the puncture needle 20 and the puncture needle 20 is retracted, the hole on the anchor piece 13 contracts under its own elastic action and has an interference fit with the anchor 50, so that the anchor 50 cannot pass through the anchor piece 13, which further increases the stability of the anchor 50 anchored to the opening and closing arm 10 and further prevents the anchor 50 from falling off the opening and closing arm 10. The anchor piece 13 can be made of a rubber material with a certain thickness, such as silica gel, rubber, latex, etc., or it can be a felt piece, or it can be a film-like structure woven from polymers, such as PET film, PTFE film, etc. (such as Figure 15d ), or it can be a mesh structure woven from metal wires or elastic polymer wires (such as Figure 15e ).

[0062] In one or more embodiments of the present application, please continue to refer to Figure 16a and 16b , a recess 32 for accommodating the opening and closing arm 10 is provided on the fixing member 30. The opening and closing arm 10 has a lower surface 15 facing the recess 32 and an upper surface 14 opposite to the lower surface 15. There is a side surface 16 between the upper surface 14 and the lower surface 15. The side surface 16 connects the upper surface 14 and the lower surface 15. A protective film 17 is covered on the upper surface 14, the lower surface 15 and the side surface 16. After the protective film 17 is provided, the anchor 50 can be anchored on the protective film 17 after the puncture needle 20 passes through the opening and closing arm 10. In addition, by providing the protective film 17 on each surface of the opening and closing arm 10, the opening and closing arm 10 is softer when contacting the tissue, protecting the tissue from being damaged.

[0063] In one or more embodiments of the present application, such as Figure 17a and 17bAs shown, the first hole 11 of the opening and closing arm 10 is a through hole 115, and the apertures of the through holes 115 are the same. The first hole 11 has a clearance fit with both the anchoring member 50 and the puncture needle 20. Thus, after the puncture needle 20 punctures through the tissue and extends out of the opening and closing arm 10, the anchoring member 50 disengages from the puncture needle 20. Then, when the puncture needle 20 is withdrawn, the anchoring member 50 is directly anchored to the tissue.

[0064] In one or more embodiments of the present application, please refer to Figures 18a to 18i , the first hole 11 of the opening and closing arm 10 includes a reverse hole 113 and a straight hole 114 communicating with the reverse hole 113. The reverse hole 113 is tapered in the direction approaching the straight hole 114. The opening and closing arm 10 is provided with a limiting groove 19, and an elastic member 18 is fixedly arranged in the limiting groove 19. The limiting groove 19 is perpendicular to the straight hole 114 and is located in the middle of the axial direction of the straight hole 114. The anchoring member 50 includes a tapered section 53, a waist section 54, a limiting section 55, and a connecting section 56 arranged in sequence from the distal end to the proximal end. The connecting section 56 penetrates through the distal end of the puncture needle 20, and the diameter of the limiting section 55 is equal to the outer diameter of the distal end of the puncture needle 20. A limiting hole 181 for restricting the waist section 54 is provided on the elastic member 18. The limiting groove 19 can be provided on the side surface of the opening and closing arm 10, as shown in 18a and 18c, and the limiting groove 19 can penetrate through the side surface of the opening and closing arm 10, as shown in 18e. The elastic member 18 is provided with pin holes (as shown in Figure 18d and 18h ), and the elastic member 18 can be fixed in the limiting groove 19 of the opening and closing arm 10 through two pins. The tapered section 53 of the anchoring member 50 is used to puncture the tissue and extend into the opening and closing arm 10. When the anchoring member 50 punctures into the opening and closing arm 10, the anchoring member 50 is coaxially arranged with the reverse hole 113 and the straight hole 114. The elastic member 18 is a metal thin sheet structure with memory, and the material can be selected from stainless steel, nitinol alloy, etc. When the elastic member 18 is assembled into the opening and closing arm 10, the limiting hole 181 of the elastic member 18 is coaxially arranged with the straight hole 114 of the opening and closing arm 10. The anchoring member 50 and the puncture needle 20 are ejected from the needle outlet hole 31 of the fixing member 30 under the control of the first suture instrument 1. After the tapered section 53 of the anchoring member 50 passes through the reverse hole 113, it enters the straight hole 114, and then passes through the limiting hole 181 of the elastic member 18, so that the waist section 54 of the anchoring member 50 is clamped in the limiting hole 181. The connecting section 56 of the anchoring member 50 penetrates through the distal end of the puncture needle 20 and is connected to the puncture needle 20. The connecting section 56 can have an interference fit with the distal end of the puncture needle 20. When the puncture needle 20 is withdrawn, since the anchoring member 50 is clamped in the limiting hole 181 of the elastic member 18, the anchoring member 50 is separated from the puncture needle 20, and only the puncture needle 20 is withdrawn, so that the anchoring member 50 and the suture 91 are limited on the opening and closing arm 10.

[0065] In one embodiment, a crack 182 is formed in the elastic member 18. The crack 182 connects to the limiting hole 181 and extends to the outer periphery of the elastic member 18. By forming the crack 182 in the elastic member 18, when the anchoring member 50 and the puncture needle 20 pierce the opening and closing arm 10 together, when the tapered section 53 of the anchoring member 50 passes through the limiting hole 181, as the tapered section 53 continues to push towards the opening and closing arm 10, the crack 182 splits and widens under the action of the tapered section 53, thereby making the limiting hole 181 larger, enabling the tapered section 53 to pass through the limiting hole 181. After the narrow waist section 54 of the anchoring member 50 is stuck in the limiting hole 181, the elastic member 18 returns to its original state, and the crack 182 is no longer stretched open. Therefore, the anchoring member 50 is fixed to the opening and closing arm 10 due to the narrow waist section 54. When the puncture needle 20 is withdrawn, because the limiting hole 181 of the elastic member 18 clamps the narrow waist section 54 of the anchoring member 50, and the deformation force of the limiting hole 181 of the elastic member 18 is greater than the frictional force of the interference fit between the puncture needle 20 and the connecting section 56 of the anchoring member 50, when the puncture needle 20 is withdrawn, the puncture needle 20 separates from the anchoring member 50, the puncture needle 20 retracts, while the anchoring member 50 and the suture 91 are fixed to the opening and closing arm 10.

[0066] In another embodiment, the limiting hole 181 is a special-shaped hole. The limiting hole 181 includes an inner hole 1811 and an outer hole 1812 larger than the inner hole diameter. A deformable convex tooth 1813 is formed between the inner hole 1811 and the outer hole 1812. In this embodiment, when the anchoring member 50 and the puncture needle 20 are inserted into the opening and closing arm 10, when the tapered section 53 of the anchoring member 50 passes through the limiting hole 181 of the elastic member 18, due to continuous pushing of the puncture needle 20 and the anchoring member 50, the convex tooth 1813 deforms and the inner hole 1811 becomes larger, thereby enabling the tapered section 53 of the anchoring member 50 to pass through the limiting hole 181. After the tapered section 53 passes through the limiting hole 181, the narrow waist section 54 of the anchoring member 50 is stuck in the limiting hole 181. Due to the material memory of the elastic member 18, the elastic member 18 returns to its original state, the convex tooth 1813 becomes the initial state, the inner hole 1811 of the limiting hole 181 becomes smaller and clamps the anchoring member 50 in the elastic member 18 and is fixed to the opening and closing arm 10. When the puncture needle 20 is withdrawn, because the anchoring member 50 is fixed to the opening and closing arm 10, and the deformation force of the limiting hole 181 of the elastic member 18 is greater than the frictional force of the interference fit between the puncture needle 20 and the anchoring member 50, when the puncture needle 20 continues to be withdrawn, the puncture needle 20 separates from the anchoring member 50. After the puncture needle 20 is withdrawn, the anchoring member 50 and the suture 91 are fixed to the opening and closing arm 10.

[0067] The present application further provides a suture system, including a second suture instrument 8 and the first suture instrument 1 of any of the above embodiments. The second suture instrument 8 includes a second puncture needle 81 and a puncture tube 82 arranged side by side with the second puncture needle 81. A needle connecting member 83 is fixed to the distal ends of the second puncture needle 81 and the puncture tube 82. The second suture instrument 8 further includes a second opening and closing arm 84. A second hole 85 for the second puncture needle 81 to pass through is formed in the second opening and closing arm 84. The opening direction of the second opening and closing arm 84 is opposite to the opening direction of the opening and closing arm 10 of the first suture instrument 1. The second suture instrument 8 further includes a second anchor (not shown in the figure), and the second anchor is arranged inside the distal end of the second puncture needle 81. The second suture instrument 8 further includes a second control rod 86 and a guiding rod 87 arranged side by side with the second control rod 86. The guiding rod 87 is arranged inside the puncture tube 82 and can move relative to the puncture tube 82. The second control rod 86 is arranged inside the second puncture needle 81 and can move relative to the second puncture needle 81. The second control rod 86 is used to separate the second anchor from the second puncture needle 81. A rod connecting member 88 is fixed to the distal ends of the second control rod 86 and the guiding rod 87. Among them, the structure of the opening and closing arm 10 on the first suture instrument 1 above, the structures of the anchor 50, the puncture needle 20, and the control rod 70, and the mutual cooperation relationships therebetween, all corresponding embodiments thereof can be correspondingly applied to the second suture instrument 8, that is, the second opening and closing arm 84 of the second suture instrument 8 can be equivalent to the opening and closing arm 10 of the first suture instrument 1, the second puncture needle 81 of the second suture instrument 8 can be equivalent to the puncture needle 20 of the first suture instrument 1, and the second control rod 81 of the second suture instrument 8 can be equivalent to the control rod 70 of the first suture instrument 1. The first suture instrument 1 can be used to suture one of the primary septum 2 and the secondary septum 3, and the second suture instrument 8 can be used to suture the other of the secondary septum 3 and the primary septum 2. In the drawings, it is mainly shown that the first suture instrument 1 sutures the primary septum 2 (such as Figures 10a to 10d ), and the second suture instrument 8 sutures the secondary septum 3 (such as Figures 20a to 20c ).

[0068] Among them, the positional relationship between the unclosed foramen ovale and the left atrium 4, left ventricle 5, right atrium 6, and right ventricle 7 in the heart can be referred to Figure 9 shown. When specifically using the suture system to suture the unclosed foramen ovale, a suture 91 can be anchored on the primary septum 2 by using the first suture instrument 1 (such as Figures 10a to 10d ). The specific detailed process has been elaborated above and will not be repeated here. Then, another suture 91 is anchored on the secondary septum 3 by using the second suture instrument 8. Because the positions of the secondary septum 3 and the primary septum 2 are different, there are differences in the structures of the second suture instrument 8 and the first suture instrument 1. The main difference is that the opening direction of the second opening and closing arm 84 is opposite to the opening direction of the opening and closing arm 10 of the first suture instrument 1. Please refer to Figure 19a , 19bAs well as in FIGS. 1a - 1d, the process of the second suture instrument 8 suturing the septum secundum 3 is as follows. After reaching the in - vivo position, the second opening - and - closing arm 84 is opened. The placement position of the second suture instrument 8 can be Figure 20a as shown, or can be Figure 20b as shown. Then, the puncture tube 82 is controlled to move proximally. Since the needle connecting member 83 is fixed to the distal end of the second puncture needle 81 and the puncture tube 82, when the puncture tube 82 moves proximally, it drives the needle connecting member 83 to move proximally, and then drives the second puncture needle 81 to first puncture the septum secundum 3 and then extend into the second hole 85 of the second opening - and - closing arm 84. Then, the guide rod 87 is controlled to move proximally. Since the rod connecting member 88 is fixed to the distal end of the second control rod 86 and the guide rod 87, when the guide rod 87 moves proximally, it drives the rod connecting member 88 to move proximally (as Figure 19b shown), and then simultaneously drives the second control rod 86 to push the second anchor in the second puncture needle 81. A suture 91 is also fixedly connected inside the second anchor, so that the second anchor and the suture 91 are withdrawn from the second puncture needle 81. Then, the guide rod 87 is controlled to move distally, driving the rod connecting member 88 and the second control rod 86 to move distally. Then, the puncture tube 82 is controlled to move distally, driving the needle connecting member 83 and the second puncture needle 81 to move distally, so that the second puncture needle 81 is withdrawn into the delivery catheter of the second suture instrument 8, while the second anchor and the suture 91 are fixed to the second opening - and - closing arm 84. Then, the second suture instrument 8 is slowly withdrawn from the foramen ovale, the second opening - and - closing arm 84 is closed, and then the second suture instrument 8 is withdrawn from the human body as a whole, leaving a suture 91 on the septum secundum 3. That is, one suture 91 is anchored to the septum primum 2 through the first suture instrument 1 of the suture system, and one suture 91 is anchored to the septum secundum 3 through the second suture instrument 8 of the suture system. Finally, the two sutures 91 on the septum primum 2 and the septum secundum 3 are tightened by a knotter. The knotter can refer to the tightening and cutting device in CN115607208A. Of course, it can also refer to other existing knotters that can tighten and cut sutures, so as to leave a knot on the two sutures to achieve suturing the unclosed foramen ovale, and then close the foramen ovale. The above is only a preferred specific embodiment of the present application, but the protection scope of the present application is not limited thereto. Any changes or substitutions that can be easily thought of by those skilled in the art within the technical scope disclosed in the present application should be covered by the protection scope of the present application. Therefore, the protection scope of the present application should be subject to the protection scope of the claims.

Claims

1. A first suture instrument for suturing an unclosed patent foramen ovale, characterized in that, The first suture instrument includes: A delivery catheter; A fixing member connected to the distal end of the delivery catheter. An opening and closing arm for supporting tissue is mounted on the fixing member. A needle exit hole for a puncture needle to pass through is formed on the fixing member, and a first hole for the puncture needle to pass through is formed on the opening and closing arm; A push rod disposed inside the delivery catheter. The push rod is connected to the opening and closing arm and is used to open or close the opening and closing arm; A puncture needle disposed inside the delivery catheter; An anchoring member disposed at or connected to the distal end of the puncture needle. A suture is fixedly connected inside the anchoring member.

2. The first suturing instrument according to claim 1, wherein The first suture instrument further includes a control rod disposed inside the puncture needle. The control rod is used to disengage the anchoring member from the puncture needle.

3. The first suturing instrument according to claim 2, wherein, The anchoring member is disposed at the distal end inside the puncture needle. The control rod is movable relative to the puncture needle and is used to eject the anchoring member from inside the puncture needle.

4. The first suturing instrument according to claim 2, wherein, The anchoring member is disposed at the distal end of the puncture needle. A first S-shaped buckle is formed at the proximal end of the anchoring member, and a second S-shaped buckle that cooperates with the first S-shaped buckle is formed at the distal end of the control rod.

5. The first suturing instrument according to claim 2, wherein The proximal end of the anchoring member is connected to the distal end of the puncture needle. A pointed head for puncturing tissue is provided at the distal end of the anchoring member. A third S-shaped buckle is formed at the proximal end of the anchoring member, and a fourth S-shaped buckle that cooperates with the third S-shaped buckle is formed at the distal end of the puncture needle. The control rod is slidable relative to the anchoring member and the puncture needle.

6. The first suturing instrument according to any one of claims 1 to 5, characterized in that, The first hole is a stepped hole having a puncture hole and a clamping hole. The aperture of the clamping hole is larger than the aperture of the puncture hole.

7. The first suturing instrument according to claim 6, wherein The opening and closing arm is provided with a mounting groove, and an anchoring piece is fixedly provided in the mounting groove. The mounting groove is located between the puncture hole and the clamping hole.

8. The first suturing instrument according to any one of claims 1 to 5, characterized in that, A recessed portion for accommodating the opening and closing arm is formed on the fixing member. The opening and closing arm has a lower surface facing the recessed portion and an upper surface opposite to the lower surface. A side surface is provided between the upper surface and the lower surface, and the side surface connects the upper surface and the lower surface. A protective film is covered on the upper surface, the lower surface and the side surface.

9. The first suturing instrument according to claim 1, characterized in that, The first hole includes a tapered hole and a straight hole communicating with the tapered hole. The tapered hole is tapered in the direction close to the straight hole. The opening and closing arm is provided with a limiting groove, and an elastic member is fixedly provided in the limiting groove. The limiting groove is perpendicular to the straight hole and is located in the middle of the axial direction of the straight hole. The anchoring member includes a tapered section, a thin waist section, a limiting section and a connecting section arranged in sequence from the distal end to the proximal end. The connecting section passes through the distal end of the puncture needle. The diameter of the limiting section is equal to the outer diameter of the puncture needle. A limiting hole for restricting the thin waist section is formed on the elastic member.

10. The first suturing instrument according to claim 9, wherein, A crack is formed on the elastic member. The crack connects the limiting hole and extends to the outer periphery of the elastic member; Or the limiting hole is a special-shaped hole. The limiting hole includes an inner hole and an outer hole larger than the aperture of the inner hole. Deformable convex teeth are formed between the inner hole and the outer hole.

11. A suture system, characterized in that, Including the first suture instrument and the second suture instrument according to any one of claims 1 to 10, the second suture instrument includes a second puncture needle and a puncture tube arranged side by side with the second puncture needle. A needle connecting member is fixed to the distal ends of the second puncture needle and the puncture tube. The second suture instrument further includes a second opening and closing arm. The second opening and closing arm is provided with a second hole for the second puncture needle to pass through. The opening direction of the second opening and closing arm is opposite to the opening direction of the opening and closing arm of the first suture instrument. The second suture instrument further includes a second anchor. The second anchor is arranged inside the distal end of the second puncture needle. The second suture instrument further includes a second control rod and a guiding rod arranged side by side with the second control rod. The guiding rod is arranged inside the puncture tube and can move relative to the puncture tube. The second control rod is arranged inside the second puncture needle and can move relative to the second puncture needle. The second control rod is used to separate the second anchor from the second puncture needle. A rod connecting member is fixed to the distal ends of the second control rod and the guiding rod.

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