Suturing device

Abstract

At least one end of a suture line is located on a suture arm, the far end of a suture needle can be connected with the suture arm, at least one end of the suture line is drawn out of the suture arm, the suture device further comprises a first control piece and a line coil, one part of the suture line is wound on the line coil, and the other part of the suture line extends towards the suture arm. At least one end of the suture line is connected with the suture arm, the first control piece can control fixation or loosening of the wire coil, the wire coil has a fixed state and a loosened state, the first control piece has an initial state and a locked state, when the first control piece is in the initial state, the wire coil is in the fixed state, and when the first control piece is in the locked state, the wire coil is in the locked state. The wire coil is in the relaxed state, and the wire coil in the relaxed state can release the suture line, so that the problems that the wire coil is always in the relaxed state, the wire coil releases too much suture line, the too much suture line is easy to accumulate to cause a knotting condition, and other operations of the suture device are easy to interfere are avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a suture device. Background Art

[0002] Patent Foramen Ovale (PFO) was previously considered by many to be a benign variation without harm. With recent clinical research, experts have reached a consensus that Patent Foramen Ovale (PFO) is one of the causes of cryptogenic stroke, migraine, paradoxical embolism, etc. Therefore, PFO occlusion or closure is required.

[0003] In the prior art, the purpose of treatment is achieved by placing a occluder to occlude the Patent Foramen Ovale. Existing occluders generally include an integrated occluding body composed of two occluding disks. The two occluding disks are respectively located on both sides of the membranous wall to achieve the functions of fixing and occluding the occluder relative to the membranous wall. There is contact friction between the two occluding disks and the membranous wall, making it difficult to adjust the position of the occluder relative to the membranous wall, which affects the occluding effect of the occluder on the defect of the membranous wall. In addition, the distance between the two occluding disks of the integrated occluding body is constant and cannot be adjusted. If the membranous wall is thin, the occluder may not occlude firmly. If the membranous wall is thick, it may cause excessive extrusion of the membranous wall and cause damage, increasing the risk of complications. Summary of the Invention

[0004] To overcome the defects of the above prior art, the present application provides an interventional suture device.

[0005] The present invention solves its technical problems through the following technical solutions:

[0006] An embodiment of the present invention provides a suture device, including a suture needle, a suture arm, and a suture thread. At least one end of the suture thread is located on the suture arm. The distal end of the suture needle can be connected to the suture arm to draw at least one end of the suture thread out of the suture arm. The suture device further includes a first control member and a thread reel. A part of the suture thread is wound around the thread reel, and another part of the suture thread extends towards the suture arm to connect at least one end of the suture thread to the suture arm.

[0007] The first control member can control the fixation or relaxation of the thread reel. The thread reel has a fixed state and a relaxed state. The first control member has an initial state and a locked state. When the first control member is in the initial state, the thread reel is in the fixed state. When the first control member is in the locked state, the thread reel is in the relaxed state. The thread reel in the relaxed state can release the suture thread.

[0008] The above suture device, by providing a first control member having an initial state and a locked state, controls the conversion between the fixed state and the relaxed state of the wire reel, so as to prevent the wire reel from always being in the relaxed state, where the wire reel releases too much suture. Excessive suture is prone to accumulate and knot, and it is also likely to interfere with other operations of the suture device. When needed, the wire reel can be relaxed, making the operation more operable and controllable. Description of the Drawings

[0009] The present invention will be further described below in conjunction with the drawings and embodiments. In the drawings:

[0010] Figure 1 is a schematic structural diagram of a suture device or a conveying device according to an embodiment;

[0011] Figure 2 is a partial schematic structural diagram of a suture device or a conveying device having a suture arm in a deployed state according to an embodiment;

[0012] Figure 3 is an exploded structural diagram of a suture device or a conveying device according to an embodiment;

[0013] Figure 4 is Figure 3 an enlarged structural diagram of part A in

[0014] Figure 5 is a partial schematic structural diagram of a suture device or a conveying device according to an embodiment;

[0015] Figure 6 is a partial schematic cross-sectional diagram of a suture device or a conveying device having a first control member in an initial state according to an embodiment;

[0016] Figure 7 is a partial schematic cross-sectional diagram of a suture device or a conveying device having a first control member in a locked state according to an embodiment;

[0017] Figure 8a is a schematic structural diagram of a slider assembly 8 according to an embodiment; Figure 8b is an exploded structural diagram of a slider assembly 8 according to an embodiment of the present invention;

[0018] Figure 9 is a simple schematic structural diagram showing the movement relationship between the first control member and the first connecting member according to an embodiment;

[0019] Figure 10 is a simple schematic structural diagram showing the movement relationship between the first control member and the first connecting member according to another embodiment;

[0020] Figure 11 is a partial schematic structural diagram of a suture device or a conveying device according to an embodiment;

[0021] Figure 12a Partial structural cross-sectional view of a suturing device or a delivery device having a first control member in an initial state according to an embodiment; Figure 12b Partial structural cross-sectional view of a suturing device or a delivery device having a first control member in a locked state according to an embodiment;

[0022] Figure 13 Partial structural view of a suturing device or a delivery device having a deployed suturing arm according to another embodiment;

[0023] Figure 14 Partial structural view of a suturing device or a delivery device according to an embodiment;

[0024] Figure 15a Partial structural cross-sectional view of a suturing device or a delivery device at a certain moment according to an embodiment; Figure 15b Partial structural cross-sectional view of a suturing device or a delivery device at another moment according to an embodiment; Figure 15c Partial structural cross-sectional view of a suturing device or a delivery device at yet another moment according to an embodiment;

[0025] Figure 16a Partial structural view of a suturing device or a delivery device from one perspective according to an embodiment; Figure 16b Partial structural view of a suturing device or a delivery device from another perspective according to an embodiment; Figure 16c Partial structural cross-sectional view of a suturing device or a delivery device from yet another perspective according to an embodiment;

[0026] Figure 17a Partial structural cross-sectional view of a suturing device or a delivery device according to an embodiment; Figure 17b For Figure 17a Partial structural view in;

[0027] Figure 18a Partial structural cross-sectional view of a suturing device or a delivery device according to an embodiment; Figure 18b For Figure 18a Structural view of a perspective of the wire cutter in; Figure 18c For Figure 18a Structural view of another perspective of the wire cutter in;

[0028] Figure 19a Structural view of a first control member in an initial state cooperating with a spool according to an embodiment; Figure 19b Structural view of a first control member in a locked state cooperating with a spool according to an embodiment; Figure 19c Connection diagram of a spool and a suture according to an embodiment;

[0029] Figure 20 is Figure 3 an enlarged structural schematic diagram of part B in

[0030] Figure 21 an exploded partial structural schematic diagram of a suturing device or a delivery device of an embodiment;

[0031] Figure 22a a structural schematic diagram of a first control member in an initial state of an embodiment; Figure 22b a structural schematic diagram of a first control member in a locked state of an embodiment;

[0032] Figure 23a a partial structural cross-sectional schematic diagram of a suturing device or a delivery device with a first control member in an initial state of an embodiment; Figure 23b is Figure 23a a cross-sectional schematic diagram of the first control member in the initial state in Figure 23c a partial structural cross-sectional schematic diagram of a suturing device or a delivery device with a first control member in a locked state of an embodiment; Figure 23d is Figure 23c a cross-sectional schematic diagram of the first control member in the locked state in

[0033] Figure 24 a partial structural cross-sectional schematic diagram of a suturing device or a delivery device of an embodiment;

[0034] Figure 25a a partial structural schematic diagram of a suturing device or a delivery device of an embodiment; Figure 25b a schematic diagram of the knob in 25a;

[0035] Figure 26a a partial structural schematic diagram of a suturing device or a delivery device of an embodiment; Figure 26b is Figure 26a a partial structural schematic diagram of

[0036] Figure 27 an exploded partial structural schematic diagram of a suturing device or a delivery device of an embodiment;

[0037] Figure 28 a structural schematic diagram of a receiving structure of an embodiment;

[0038] Figure 29a a schematic diagram of the state of the suture at a certain moment during the process of suturing the foramen ovale by a suturing device or a delivery device of an embodiment; Figure 29b a schematic diagram of the state of the suture at a certain moment during the process of suturing the foramen ovale by a suturing device or a delivery device of an embodiment; Figure 29c a schematic diagram of the state of the suture at a certain moment during the process of suturing the foramen ovale by a suturing device or a delivery device of an embodiment. Specific Embodiments

[0039] For a clearer understanding of the technical features, objectives, and effects of the present invention, the specific embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

[0040] Exemplary embodiments of the present disclosure will now be described in more detail 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 may 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.

[0041] It should be understood that the terms used herein are for the purpose of describing specific example embodiments only and are not intended to be limiting. Unless the context clearly dictates otherwise, the singular forms "a", "an", and "the" as used herein may also include the plural forms. The terms "comprising", "including", "containing", and "having" 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. The method steps, processes, and operations described herein are not to be construed as necessarily requiring them to be performed in the particular order described or illustrated, unless the order of performance is explicitly stated. It should also be understood that additional or alternative steps may be used.

[0042] 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. Unless the context clearly indicates otherwise, terms such as "first", "second", and other numerical terms used herein do not imply an order or sequence. 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 example embodiments.

[0043] For ease of description, spatial relative relationship terms may be used in the text to describe the relationship of one element or feature shown in the figure with respect to another element or feature. These relative relationship terms are, for example, "inner", "outer", "inner side", "outer side", "below", "beneath", "above", "over", etc. Such spatial relative relationship terms are intended to include different orientations of the device during use or operation in addition to the orientations depicted in the figure. For example, if the device in the figure is flipped, an element described as "below" or "beneath" other elements or features will then be oriented as "above" or "over" other elements or features. Thus, the exemplary term "below" can include both upper and lower 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 interpreted accordingly.

[0044] It should be noted that the terms "distal end" and "proximal end" are used as orientation terms, which are commonly used terms in the field of interventional medical devices. Among them, the "distal end" refers to the end far from the operator during the surgical procedure, and the "proximal end" refers to the end 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.

[0045] The suture device in the embodiments of the present invention includes, but is not limited to, suturing patent foramen ovale, edge-to-edge suture repair of valves, chordae tendineae suture repair, vascular suture, etc.

[0046] Referring to Figure 1 and Figure 2 , in this embodiment, a suture device 100 is provided, which includes a handle 1 and a sheath 2 connected to each other. The suture device 100 further includes a suture needle 3, a suture arm 4, and a suture thread 5. At least one end of the suture thread 5 can be located on the suture arm 4. The suture arm 4 has a transport state and a deployed state that can be converted into each other. When in the deployed state, the distal end of the suture needle 3 can be connected to the suture arm 4 to draw at least one end of the suture thread 5 out of the suture arm 4. The suture needle 3 and the suture thread 5 are arranged in the sheath 2. The suture arm 4 is arranged at the distal end of the sheath 2 or a position close to the distal end. The proximal end of the suture needle 3 is arranged on the handle 1. Figure 1 This is the transport state of the suture arm 4. The suture arm 4 has not been deployed yet, and the suture needle 3 has not extended out. Figure 2 This is the deployed state of the suture arm 4. The suture needle 3 has extended out, and the distal end of the suture needle 3 is about to be connected to the suture arm 4.

[0047] Referring to Figures 3 to 7 , in one embodiment, the suture device 100 further includes a first connecting member 6, a second connecting member 7, a slider assembly 8, and a first control member 9. As Figure 8a and Figure 8bAs shown, the slider assembly 8 includes a first slider 81, a second slider 82 and an elastic member 83 which are connected to each other. The second slider 82 and the elastic member 83 are axially arranged within the first slider 81, and the second slider 82 is movable relative to the first slider 81. As Figure 4 , 6 and Figure 7 shown, two ends of the first connecting member 6 are respectively connected to the first slider 81 and the first control member 9, and two ends of the second connecting member 7 are respectively connected to the suture arm 4 and the second slider 82, so as to control the movement of the first slider 81 through the first control member 9. The first slider 81 drives the second slider 82 to move through the elastic member 83, thereby controlling the movement of the suture arm 4, that is, converting from the conveying state to the unfolding state.

[0048] Wherein, the first control member 9 has an initial state and a locked state. Figure 6 In Figure 7 , the first control member 9 is in the initial state, and in

[0049] Figure 2 Figure 4 and , the first control member 9 is in the locked state. During the process of the first control member 9 moving from the initial state to the locked state, the suture arm 4 converts from the conveying state to the unfolding state. The first control member 9 drives the first slider 81 to axially move in the first direction a through the first connecting member 6, forming a first movement stroke relative to the handle housing. The first slider 81 drives the second slider 82 to axially move in the first direction a through the elastic member 83, forming a second movement stroke relative to the handle housing. The first movement stroke is greater than the second movement stroke, so that the elastic member 83 can generate elastic deformation within the first slider 81.

[0050] It can be understood that since the second slider 82 is connected to the suture arm 4 through the second connecting member 7, when the second slider 82 moves axially in the first direction a, it drives the second connecting member 7 and the suture arm 4 to move axially in the first direction a until the suture arm 4 moves to abut against the inner wall of the opening 12 on the sheath tube 2. At this time, the second connecting member 7 and the suture arm 4 can no longer move in the first direction a, and the suture arm 4 is in the deployed state. It can be considered that the first control member 9 is in a pre-locked state at this time, and this pre-locked state is a certain state between the initial state and the locked state. In the pre-locked state, the second slider 82 connected to the second connecting member 7 is also stationary relative to the housing because the second connecting member 7 cannot continue to move in the first direction a, that is, the second slider 82 has completed the second movement stroke. However, at this time, the suture arm 4 can still be restored to the delivery state under the action of an external force, so the suture arm 4 is not in a truly locked state, and the first control member 9 has only reached the pre-locked state and has not reached the locked state. Next, if the first control member 9 is continuously moved in the original direction, the first connecting member 6 can be driven to drive the first slider 81 to continue to move axially in the first direction a, finally making the first movement stroke greater than the second movement stroke, resulting in elastic deformation of the elastic member 83 in the first slider 81 between the first slider 81 and the second slider 82. When the first control member 9 reaches the locked state, since the force exerted by the locked first control member 9 on the first slider 81, the force exerted by the elastic member that generates the above elastic deformation on the first slider 81, and the frictional force exerted by the handle housing 10 on the first slider 81 can achieve force balance, the first control member 9, the first connecting member 6, the first slider 81, the elastic member 83, and the second slider 82 can all remain stationary relative to the handle housing 10. That is to say, the first control member 9, the first connecting member 6, the first slider 81, the elastic member 83, and the second slider 82 can remain relatively fixed, which can prevent the suture arm 4 from rebounding back to the delivery state or an uncertain state between the delivery state and the deployed state, thereby realizing the relative fixation of the suture arm 4 and the handle housing 10. That is to say, by locking the first control member 9, the suture arm 4 in the deployed state can be locked, avoiding the uncertain movement of the second slider 82 under the action of an accidental external force, thereby facilitating the connection of the suture needle 3 and the suture arm 4 and improving the success rate of the operation.

[0051] It can be understood that before the elastic member 83 undergoes the above-mentioned elastic deformation, it may have a small initial compressive elastic deformation. The elastic member 83 with the initial elastic deformation is placed inside the first slider 81, and its two ends are respectively connected to the first slider 81 and the second slider 82. Since the initial elastic deformation is small, it cannot offset the static friction between the first slider 81 and the second slider 82, nor can it drive the sewing arm 4 to move. Therefore, before undergoing the above-mentioned elastic deformation, it cannot drive the second slider 82 and the sewing arm 4 to move, keeping the sewing arm 4 in the conveying state. In other embodiments, before the elastic member 83 undergoes the above-mentioned elastic deformation, the elastic member 83 can also be in a natural state without an initial elastic deformation. At this time, the elastic member can be located on the proximal side of the second slider or on the distal side of the second slider. In other embodiments, before the elastic member 83 undergoes the above-mentioned elastic deformation, it may have a small initial tensile elastic deformation. At this time, the second slider can be located on the distal side of the elastic member, the proximal end of the elastic member is connected to the first slider, and the distal end of the elastic member is connected to the second slider.

[0052] In this embodiment, please refer to Figure 5 , the first control member 9 includes a first operation portion 91 and a main body portion 92 that are connected to each other. The first operation portion 91 is for the operator to operate. Rotating the first operation portion 91 can drive the main body portion 92 to rotate, and the first connecting member 6 is connected to the main body portion 92. In other embodiments, the first operation portion 91 may not be provided, and the main body portion 92 can be directly rotated. When locking is required, the main body portion 92 can be locked by a separate locking member or directly by hand.

[0053] Refer to Figure 9 , Figure 9 which is a schematic trajectory diagram for explaining the movement of the first control member 9 from the initial state to the locked state. The connection point between the first connecting member 6 and the main body portion 92 is 61, and the connection point between the first connecting member 6 and the first slider 81 is 62. As the main body portion 92 rotates, the connection point 61 between the first connecting member 6 and the main body portion 92 rotates along the direction b, moving from 61a to 61b and finally reaching 61c. The connection point 61 makes a circular arc movement on the main body portion 92, forming a circular arc path S; the connection point 62 between the first connecting member 6 and the first slider 81 moves axially, moving from 62a to 62b and finally reaching 62c. With such a design, the circular arc movement can be converted into a linear movement, making the operability stronger and the user experience better.

[0054] Specifically, the arc path S includes a starting end 61a and an ending end 61c. The arc path S further includes a transition point 61b which is located between the starting end 61a and the ending end 61c in the arc path S. When one end of the first connecting member 6 connected to the main body portion 92 of the first control member 9 is located at the transition point 61b, the axial distance between the central rotation point O of the main body portion 92 of the first control member 9 and the first slider 81 is the largest. At this time, the axial movement distance of the first slider 81 is the farthest, and the degree of elastic deformation of the elastic member 83 is the largest. However, at this time, the first control member 9 does not reach the locking position, that is, it does not reach the locked state. The first control member 9 continues to move in the original direction, driving the first slider 81 to move in a direction opposite to the first direction a. At this time, the degree of elastic deformation of the elastic member 83 slightly becomes smaller until the first control member 9 reaches the locking position. At the locking position, the first control member 9 is limited or locked by other components (such as the handle housing), so that the elastically deformed elastic member 83 cannot drive the first slider 81 to move in a direction opposite to the first direction a, thus ensuring the locked state of the first control member 9. It can be understood that in the above process of "the elastically deformed elastic member 83 exerts a force on the first slider 81, thereby driving the first slider 81 to move in a direction opposite to the first direction a", even if the first slider 81 has moved a certain distance in a direction opposite to the first direction a, as long as the first movement stroke is still greater than the second movement stroke, that is, the distance that the first slider 81 moves in the first direction a is still greater than the distance that the second slider 82 moves in the first direction a, at this time, the acting force of the elastic deformation of the elastic member 83 still acts on the second slider 82 in the first direction a, so that the second slider 82 remains stationary, and the suture arm 4 connected to the second slider 82 remains in the unfolded state.

[0055] At Figure 9In the pre-locked state, the connection point of the first connecting member 6 and the main body portion 92 is located at the pre-locking point 61e, which may be located at a position between the starting end 61a and the transition point 61b in the arc path S. During the process of the connection point of the first connecting member 6 and the main body portion 92 moving from the starting end 61a to the pre-locking point 61e, the first slider 81 drives the second slider 82 to move together until the second slider 82 completes the second movement stroke, thereby driving the suture arm 4 to move from the conveying state to the unfolded state. However, the suture arm 4 cannot be locked in the unfolded state because there is no locking member designed specifically other than the resistance of the handle housing 10, so it can still move towards the conveying state under an accidental external force. During the process of the connection point of the first connecting member 6 and the main body portion 92 moving from the pre-locking point 61e to the end point 61c, the elastic member 83 undergoes elastic deformation within the first slider 81 until the first control member 9 is in the locked state. At this time, the suture arm 4 is also in the locked state and cannot move relative to the handle housing 10. Therefore, when the connection point of the first connecting member 6 and the main body portion 92 is located at a position after the pre-locking point 61e, the first control member 9 can be in the locked state. It can be understood that the transition point 61b is located between the pre-locking point 61e and the end point 61c.

[0056] See Figure 3 and Figure 5 , the handle 1 includes a handle housing 10, a slider assembly 8, a first connecting member 6, and a main body portion 92 are disposed within the handle housing 10, and a first operating portion 91 passes through the handle housing 10 and is disposed outside the handle housing 10. As Figure 5 shown, when the first operating portion 91 is in the locked state, the first operating portion 91 abuts against the handle housing 10. Specifically, see Figure 5 , Figure 11 and Figure 19a , the first operating portion 91 includes a first arm 911, a second arm 912, and a connecting arm 913. The connecting arm 913 connects one end of the first arm 911 and one end of the second arm 912 respectively. The other ends of the first arm 911 and the second arm 912 are respectively connected to the main body portion 92. The operator can hold the connecting arm 913 to operate the movement of the first operating portion 91, and the connecting arm 913 is used to abut against the handle housing 10.

[0057] Combined with Figure 7 and Figure 9The first control member 9 shown rotates continuously in the direction b until it abuts against the handle housing 10. The handle housing 10 prevents the first control member 9 from further rotating in the direction b. Due to the force generated by the elastic deformation of the elastic member 83, the first control member 9 cannot rotate in the direction opposite to the direction b either, thus achieving a force balance and realizing the locking of the first control member 9. In other embodiments, the first control member 9 can also be locked by separately providing a locking member and locking it through the connection between the locking member and the first control member 9.

[0058] Combined with Figure 9 , in this embodiment, since there is no locking member other than the handle housing designed to lock the first control member 9, the first control member 9 is mainly locked by the abutment between the handle housing 10 and the first control member 9. Additionally, when operating the first control member 9, during the process of rotating the first control member 9 from the initial state to the locked state, the end of the first connecting member 6 connected to the first control member 9 moves in an arc on the first control member 9. Therefore, when the first control member 9 is in the locked state in this embodiment, the end of the first connecting member 6 connected to the main body portion 92 of the first control member 9 needs to be located at the transition point 61b or a certain position (such as 61c) after the transition point 61b to ensure the locking performance. If the end of the first connecting member 6 connected to the main body portion 92 of the first control member 9 is located at a point Q before the transition point 61b and no external force is applied to the first control member 9, through the force analysis diagram, at point Q, the elastic member 83 that generates elastic deformation generates a force F on the main body portion 92 of the first control member 9 through the first connecting member 6. This force F has a component force F1 in the circumferential direction and towards the direction opposite to the b direction. This component force F1 can drive the end of the first connecting member 6 connected to the main body portion 92 of the first control member 9 to move in the direction opposite to the b direction, easily causing the end of the first connecting member 6 connected to the main body portion 92 of the first control member 9 to return to the starting end 61a. Therefore, point Q cannot achieve a force balance, and the first control member 9 cannot reach the locked state.

[0059] The main body portion 92 has a central rotation point O, and the main body portion 92 rotates around the central rotation point O. When the end of the first connecting member 6 connected to the main body portion 92 of the first control member 9 is located at the transition point 61b, the connection point 61b between the first connecting member 6 and the main body portion 92, the connection point 62b between the first connecting member 6 and the first slider 81, and the central rotation point O are on the same straight line.

[0060] In other embodiments, when the first control member 9 reaches the locked position, the end of the first connecting member 6 connected to the main body portion 92 of the first control member 9 can also be just located at the transition point 61b, that is, the end point 61c coincides with the transition point 61b.

[0061] In Figure 9In [the figure], the first connecting member 6 is generally linear. In one embodiment, referring to Figure 10 , the first connecting member 6 may generally be in a broken line shape. In other embodiments, the first connecting member 6 may also generally be in a curved shape.

[0062] In one embodiment, the two ends of the first connecting member 6 are respectively pivotally connected to the first control member 9 and the first slider 81, so as to have a more flexible connection method, which is beneficial to the connection of the first connecting member 6 with the first control member 9 and the first slider 81 at different angles, thus facilitating the relative movement among the first control member 9, the first connecting member 6 and the first slider 81.

[0063] In one embodiment, referring again to Figure 7 and Figure 8b , the second slider 82 is arranged inside the first slider 81, the fixing post 84 is arranged inside the second slider 82. The proximal end of the second connecting member 7 first penetrates into the first slider 81, then enters the second slider 82, passes through the fixing post 84, then penetrates out of the second slider 82. By rotating the fixing post 84, the second connecting member 7 is wound around the fixing post 84, and finally the fixing post 84 is fixed with a screw 85, so as to fix the second connecting member 7 on the second slider 82.

[0064] In one embodiment, the first direction a is the direction of movement from the first end to the second end. Referring to Figure 6 and Figure 7 , in this embodiment, the first direction a is the direction from the distal end to the proximal end. Among them, the elastic member 83 is a compression-type elastic member, and the elastic member 83 is arranged on one side close to the distal end inside the first slider 81. The compression-type elastic member (such as a compression spring) can be understood as compressing the elastic member, so that the elastic member is shortened and deformed, and the elastic member has a tendency to recover the deformation, so as to store the deformation energy. In another embodiment, the elastic member 83 is a tension-type elastic member, and the elastic member 83 is arranged on one side close to the proximal end inside the first slider 81. Among them, the tension-type elastic member (such as a tension spring) can be understood as stretching the elastic member, so that the elastic member is elongated and deformed, and the elastic member has a tendency to recover the deformation, so as to store the deformation energy. It can be understood that the first direction a can also be the direction from the proximal end to the distal end.

[0065] The suture device 100 includes a first control assembly (or suture arm control assembly) 101 and a second control assembly (or needle holder control assembly) 102. Referring to Figure 6 and Figure 7 , the first control assembly 101 includes the first connecting member 6, the second connecting member 7, the slider assembly 8 and the first control member 9. The first control assembly 101 is used to control the mutual conversion of the suture arm 4 between the conveying state and the unfolding state; referring to Figure 2 , Figure 3 , Figure 11As shown in FIGS. 11 and 12, the second control assembly 102 is connected to the suture needle 3 and is used to control the extension and retraction of the suture needle 3. When the suture needle 3 extends, the distal end of the suture needle 3 can be connected to the suture arm 4.

[0066] Among them, the first control member 9 has an axially penetrating through-hole 93. When the first control member 9 is in the locked state, the second control assembly 102 penetrates into the through-hole 93 for axial movement; when the first control member 9 is in the initial state, the second control assembly 102 is blocked from penetrating into the through-hole 93, restricting the axial movement of the second control assembly 102. Such a setting is to ensure that only when the suture arm 4 is in the unfolded state can the suture needle 3 be extended to connect with the suture arm 4, which can ensure that the suture arm 4 needs to be unfolded first and then the suture needle 3 is extended, avoiding the suture needle 3 being extended when the suture arm 4 is not unfolded, which may cause damage to the internal tissues by the suture needle 3.

[0067] In this embodiment, the first control member 9 is arranged on the distal side of the second control assembly 102. The second control assembly 102 drives the suture needle 3 to extend distally, so that the distal end of the suture needle 3 passes through the through-hole 93 and extends into the proximal end of the suture arm 4, and further at least one end of the suture thread 5 is drawn out from the suture arm 4.

[0068] In another embodiment, referring to Figure 13 , the distal end of the suture needle 3 can be constrained by the sheath 2 in the delivery state. The second control assembly 102 drives the suture needle 3 to move proximally. When it moves to the position of the opening 12, the distal part of the suture needle 3 extends and forms an everted shape. The second control assembly 102 continues to drive the suture needle 3 to move proximally until the suture needle 3 is connected to the suture arm 4. The second control assembly 102 further drives the suture needle 3 to move proximally, and the distal end of the suture needle 3 retracts in the C direction, so as to disengage from the suture arm 4, and at least one end of the suture thread 5 on the suture arm 4 is drawn out until the distal end of the suture needle 3 enters the sheath 2 again, and the distal part of the everted suture needle 3 is straightened. It can be understood that in this embodiment, the first control member 9 is arranged on the proximal side of the second control assembly 102. Only when the first control member 9 is in the locked state can the proximal end of the second control assembly 102 penetrate into the through-hole 93 for axial movement.

[0069] Referring to Figure 3 、 Figure 12a 、 Figure 12b and Figure 14, the second control component 102 includes a first gear 1021, a first rack 1022, and a needle holder 103. The first gear 1021 and the first rack 1022 are meshed with each other. The needle holder 103 is respectively connected to the suture needle 3 and the first rack 1022. By rotating the first gear 1021, the needle holder 103 is driven to move axially through the first rack 1022, so as to control the extension and retraction of the suture needle 3. When the suture needle 3 extends, the distal end of the suture needle 3 is connected to the suture arm 4, thereby realizing the precise movement control of the suture needle 3 and improving the operability. Further, the second control component 102 further includes a second operation part (or gear operation part) 1023, and the second operation part 1023 is connected to the first gear 1021. Operating the second operation part 1023 drives the first gear 1021 to rotate.

[0070] In one embodiment, the first rack 1022 includes an engagement section 10221 and a connection section 10222. The engagement section 10221 and the connection section 10222 are axially connected. The engagement section 10221 cooperates with the first gear 1021, and the connection section 10222 is connected to the proximal end of the suture needle 3. Among them, the engagement section 10221 is a groove structure on the first rack 1022, and the first gear 1021 is restricted to move in the groove structure.

[0071] In one embodiment, the first rack 1022 includes a penetration section 10223 and an engagement section 10221. The penetration section 10223 and the engagement section 10221 are axially connected. The engagement section 10221 cooperates with the first gear 1021, and the penetration section 10223 is used to penetrate the through hole 93 of the first control member 9 in FIG. 12.

[0072] In another embodiment, the first rack 1022 may include an engagement section 10221, a connection section 10222, and a penetration section 10223, which are axially connected in sequence.

[0073] In one embodiment, in combination with Figure 2 , Figure 3 , Figure 13 and Figure 14 , the suture needle 3 includes a first suture needle 31 and a second suture needle 32. The needle holder 103 includes a first needle holder 1031 and a second needle holder 1032. The first suture needle 31 is connected to the first needle holder 1031, and the second suture needle 32 is connected to the second needle holder 1032. The second control component 102 further includes a second gear 2021 and a second rack 2022 that cooperate with each other. By rotating the first gear 1021, the first needle holder 1031 is driven to move axially through the first rack 1022, so as to control the extension and retraction of the first suture needle 31; by rotating the second gear 2021, the second needle holder 1032 is driven to move axially through the second rack 2022, so as to control the extension and retraction of the second suture needle 32. Thus, separate operations can be performed on the first suture needle 31 and the second suture needle 32 respectively, with stronger flexibility and improved operability.

[0074] Combined with Figure 3 and Figure 14 Figure 3 and Figure 14 , the first rack 1022 and the second rack 2022 are arranged side by side within the handle housing 10. The first gear 1021 and the second gear 2021 are connected by a connecting rod 3021. The connecting rod 3021 passes through the first gear 1021 and the second gear 2021, and both ends of the connecting rod 3021 are fixed to the handle housing 10. The first gear 1021 and the second gear 2021 rotate around the connecting rod 3021 respectively.

[0075] In one embodiment, referring to Figure 15a 、 15b and 15c, the suturing device 100 further includes an actuating assembly 304, a first support member 301 and a second support member 302. The first support member 301 is movably connected to the needle holder 103. The actuating assembly 304 is used to control the extension and retraction of the suture needle 3 from the sheath tube. When the suture needle 3 extends, the distal end of the suture needle 3 is connected to the suture arm 4. The needle holder 103 is connected to the suture needle 3. The actuating assembly 304 and the needle holder 103 are detachably connected in a direction perpendicular to the axial direction.

[0076] After the actuating assembly 304 and the needle holder 103 are connected, the first support member 301 is located outside the needle holder 103, and the second support member 302 is located outside the actuating assembly 304. The straight line M in the axial direction where the first support member 301 is located and the straight line N in the axial direction where the second support member 302 is located are oppositely arranged in a direction perpendicular to the axial direction, and are used to support the actuating assembly 304 and the needle holder 103 in a direction perpendicular to the axial direction. The interconnected actuating assembly 304 and needle holder 103 can axially move between the first support member 301 and the second support member 302. When the first support member 301 moves proximally, the first support member 301 drives the needle holder 103 to move proximally, and the needle holder 103 drives the actuating assembly 304 to move proximally until the actuating assembly 304 and the needle holder 103 are disengaged. After the two are disengaged, the first support member 301 can still drive the needle holder 103 to continue moving proximally.

[0077] In this embodiment, the actuating assembly 304 may include a first gear 1021 and a first rack 1022 that mesh with each other. At this time, the first rack 1022 and the needle holder 103 are detachably connected in a direction perpendicular to the axial direction. When the first rack 1022 and the needle holder 103 are connected (as Figure 15aAs shown, the first support member 301 is located outside the needle holder 103 (i.e., below the needle holder 103 as shown in the figure), and the second support member 302 is located outside the first rack 1022 (i.e., above the first rack 1022 as shown in the figure). The straight line M in the axial direction where the first support member 301 is located and the straight line N in the axial direction where the second support member 302 is located are oppositely arranged in the direction perpendicular to the axial direction, so as to support the first rack 1022 and the needle holder 103 in the direction perpendicular to the axial direction, so that the interconnected first rack 1022 and needle holder 103 can axially move between the first support member 301 and the second support member 302. When the first support member 301 moves proximally, the first support member 301 drives the needle holder 103 to move proximally, and the needle holder 103 drives the first rack 1022 to move proximally until the first rack 1022 and the needle holder 103 are disengaged. After the two are disengaged, the first support member 301 can still drive the needle holder 103 to continue to move proximally.

[0078] In other embodiments, the actuating assembly 304 may not adopt the way of gear-rack meshing. The actuating assembly 304 may be a connecting structure. By pulling or pushing the connecting structure, the axial actuating function is realized to control the extension and retraction of the suture needle 3. The connecting structure may be a rod-shaped, block-shaped or other structures.

[0079] In this embodiment, first of all, in this embodiment, by providing the first support member 301 and the second support member 302, when the actuating assembly 304 is connected to the needle holder 103, the first support member 301 is located outside the needle holder 103, and the second support member 302 is located outside the actuating assembly 304. The straight line M in the axial direction where the first support member 301 is located and the straight line N in the axial direction where the second support member 302 is located are oppositely arranged in the direction perpendicular to the axial direction, and are used to support the actuating assembly 304 and the needle holder 103 in the direction perpendicular to the axial direction. That is, the first support member 301 is used to support the needle holder 103, and the second support member 302 is used to support the actuating assembly 304. The first support member 301, the needle holder 103, the actuating assembly 304 and the second support member 302 support each other on the same plane perpendicular to the axial direction, so that the four are kept from separating in the direction perpendicular to the axial direction, but does not affect the axially movable actuating assembly 304 and the needle holder 103 can axially move between the first support member 301 and the second support member 302, so as not to affect the control of the extension and retraction of the suture needle 3 by axially moving the actuating assembly.

[0080] Secondly, the first support member 301 is movably connected to the needle holder 103, and the actuating assembly 304 and the needle holder 103 are detachably connected in a direction perpendicular to the axial direction. When the first support member 301 moves proximally, the first support member 301 drives the needle holder 103 to move proximally. At this time, the first support member 301, the needle holder 103, the actuating assembly 304, and the second support member 302 still support each other on the same plane perpendicular to the axial direction. Even if there is an axial displacement among these four components, they still remain non-detached in the direction perpendicular to the axial direction. Moreover, the needle holder 103 can drive the actuating assembly 304 to move proximally. Since the actuating assembly 304 controls the extension and retraction of the suture needle 3 through the needle holder 103, before the actuating assembly 304 and the needle holder 103 are detached, the needle holder 103 can first drive the actuating assembly 304 to move proximally, thereby reducing the interference of the actuating assembly 304 on other components of the suture device 100 and improving the operating performance.

[0081] Thirdly, by connecting the needle holder 103 to the suture needle 3 and enabling the actuating assembly 304 and the needle holder 103 to be detached, not only can the suture needle 3 that has carried out the suture thread 5 (i.e., the suture needle 3 with the suture thread 5 that has completed the suture action in the body) be withdrawn from the body, but also when the suture needle 3 is withdrawn from the body, the partial suture thread 5 connected to the suture needle 3 can be withdrawn from the body, facilitating the operator to send the knotter into the body along the partial suture thread 5 withdrawn from the body, or directly tying the partial suture thread 5 withdrawn from the body and then pushing it into the body to complete the suture fixation.

[0082] The above-mentioned "can first drive the actuating assembly 304 to move proximally, and can reduce the interference of the actuating assembly 304 on other components of the suture device 100", when applied to specific embodiments, includes but is not limited to the following situations: Refer to Figure 12b , when the first control member 9 is in the locked state, the first rack 1022 of the second control assembly 102 penetrates into the through hole 93 for axial movement until the second control assembly 102 controls the suture needle 3 to complete the suture action. At this time, it is necessary to withdraw the first rack 1022 from the through hole 93, that is, it is necessary to drive the first rack 1022 to move proximally so that the first control member 9 can return to the initial state, thereby restoring the suture arm 4 to the conveying state, so as to facilitate withdrawal from the body. Therefore, during the process of withdrawing the suture needle, the actuating assembly 304 can be driven to move proximally, which can reduce the interference of the actuating assembly 304 on other components of the suture device 100 and has practical significance.

[0083] In one embodiment, refer to Figure 16a 、 16bAnd 16c, the suturing device 100 further includes a sleeve-like structure 401. The sleeve-like structure 401 includes a first support member 301. The sleeve-like structure 401 is movably connected to the needle holder 103. The proximal end of the needle holder 103 is disposed within the sleeve-like structure 401, and the distal end of the needle holder 103 can extend out of or retract into the sleeve-like structure 401. Among them, the first support member 301 can be the side wall of the sleeve-like structure 401 or an element disposed on the side wall of the sleeve-like structure 401.

[0084] In an embodiment, one of the sleeve-like structure 401 and the needle holder 103 is provided with a through-hole structure 1030, and the other of the sleeve-like structure 401 and the needle holder 103 is provided with a fixing structure 1033. The fixing structure 1033 is restricted to move within the through-hole structure 1030, realizing the movable connection between the sleeve-like structure 401 and the needle holder 103, that is, the movable connection between the first support member 301 and the needle holder 103. In one embodiment, the sleeve-like structure 401 is provided with an elongated through-hole structure 1030, and the needle holder 103 is provided with a fixing structure 1033. The fixing structure 1033 is a hook-like structure 10331. The hook-like structure 10331 can abut against the inner wall 10301 of the through-hole structure 1030, so that the hook-like structure 10331 is restricted to perform axial movement within the elongated through-hole structure 1030. In another embodiment, see Figure 17a and 17b , the sleeve-like structure 401 is provided with a fixing structure 1033. The fixing structure 1033 is a rod-like structure 10332. The needle holder 103 is provided with an elongated through-hole structure 1030. The rod-like structure 10332 is inserted into the elongated through-hole structure 1030 and can abut against the inner wall 10301 of the through-hole structure 1030, so that the rod-like structure 10332 is restricted to perform axial movement within the elongated through-hole structure 1030. If there are multiple needle holders 103, multiple fixing structures 1033 can be provided and respectively restricted in different through-hole structures 1030 to realize the independent movement of multiple needle holders 103.

[0085] In other embodiments, the first support member 301 may not be provided on the sleeve-like structure 401. The first support member 301 may be a planar structure, such as flat plates, rods, strips, blocks, etc. of various shapes. Connecting members are provided on the planar structure for movable connection with the needle holder 103.

[0086] See Figure 3 , the handle includes a detachably connected handle housing 10 and a sleeve-like structure housing 13. Combining with FIG. 16 and Figure 17a, the sheath structure housing 13 is connected to the sheath structure 401, and the sheath structure housing 13 is disposed outside the sheath structure 401. A connecting member 131 is provided on the sheath structure housing 13. The connecting member 131 is inserted into the handle housing 10 to fixedly connect the handle housing 10 and the sheath structure housing 13. A slit 132 is provided at the position where the connecting member 131 is disposed in the sheath structure housing 13. The slit 132 enables the position where the connecting member 131 is disposed in the sheath structure housing 13 to be relatively movable with respect to other positions in the sheath structure housing 13. When it is necessary to fix the handle housing 10 and the sheath structure housing 13 together, press inward in a direction perpendicular to the axial direction at the position where the connecting member 131 is disposed in the sheath structure housing 13, so that the connecting member 131 can be easily inserted into the handle housing 10. After the connecting member 131 is inserted into the handle housing 10, the connecting member 131 can recover its original shape outward in a direction perpendicular to the axial direction, so as to be able to engage with the handle housing 10 in a direction perpendicular to the axial direction, thereby realizing the fixation between the handle housing 10 and the sheath structure housing 13. When it is necessary to detach and remove the sheath structure housing 13 from the handle housing 10, press inward in a direction perpendicular to the axial direction at the position where the connecting member 131 is disposed in the sheath structure housing 13, so that the connecting member 131 can be easily disengaged from the handle housing 10, and then pull out the sheath structure housing 13 to achieve disengagement.

[0087] See Figure 15a , 15b and 15c, in one embodiment, the second support member 302 is disposed on the inner wall of the handle housing 10. Wherein, a first groove 3041 is provided on the actuating assembly 304, and the second support member 302 can be received in the first groove 3041. When the first support member 301 moves proximally, the first support member 301 drives the needle seat 103 to move proximally, and the needle seat 103 drives the actuating assembly 304 to move proximally until the second support member 302 is received in the first groove 3041, so that the actuating assembly 304 and the needle seat 103 are disengaged from each other. Specifically, as Figure 15a shown, at this time, the sheath structure housing 13 and the handle housing 10 have not been disengaged, the second support member 302 is not received in the first groove 3041, and the first support member 301, the needle seat 103, the actuating assembly 304 and the second support member 302 support and connect with each other on the same plane in a direction perpendicular to the axial direction. The actuating assembly 304 and the needle seat 103 connected to each other can axially move between the first support member 301 and the second support member 302. As Figure 15bAs shown, at this time, when the sleeve structure housing 13 is pulled proximally, the sleeve structure housing 13 is disengaged from the handle housing 10. However, the second support member 302 is not received in the first groove 3041. The first support member 301, the needle holder 103, the actuation assembly 304, and the second support member 302 still support each other on the same plane perpendicular to the axial direction. At this time, the actuation assembly 304 has completely moved out of the sleeve structure 401, and the needle holder 103 remains stationary relative to the housing 13. As Figure 15c As shown, as the sleeve structure housing 13 is continuously pulled proximally, the sleeve structure 401 drives the needle holder 103 to move proximally, and the needle holder 103 drives the actuation assembly 304 to move proximally until the second support member 302 is received in the first groove 3041. The balance of forces of the first support member 301, the needle holder 103, the actuation assembly 304, and the second support member 302 on the same plane perpendicular to the axial direction is gradually broken. In particular, the force provided by the second support member 302 on the part of the actuation assembly 304 connected to the needle holder 103 gradually decreases. Since the magnitude of the force of the needle holder 103 on the actuation assembly 304 perpendicular to the axial direction and towards the actuation assembly 304 does not change significantly, the actuation assembly 304 will pivot with the second support member 302 as the fulcrum, and the actuation assembly 304 will tilt in the direction perpendicular to the axial direction (i.e., the d direction) at the contact position between the needle holder 103 and the actuation assembly 304. Since the actuation assembly 304 has completely moved out of the sleeve structure 401, the disengagement between the actuation assembly 304 and the needle holder 103 can be completed very smoothly.

[0088] Further, one of the actuation assembly 304 and the needle holder 103 is provided with a protrusion 22, and the other of the actuation assembly 304 and the needle holder 103 is provided with a recess 33. The protrusion 22 and the recess 33 cooperate with each other to detachably connect the actuation assembly 304 and the needle holder 103 in the direction perpendicular to the axial direction, which can ensure effective connection when one of the actuation assembly 304 and the needle holder 103 drives the other to move. In other embodiments, the protrusion 22 and the recess 33 may not be provided, and the connection between the actuation assembly 304 and the needle holder 103 can be ensured only by the frictional force between the actuation assembly 304 and the needle holder 103. It can be understood that a rough surface can be provided on the contact surface of the actuation assembly 304 or / and the needle holder 103.

[0089] In another embodiment, the sleeve structure 401 further includes a second support member 302, that is, the second support member 302 is also disposed on the sleeve structure 401. At this time, the contact position between the needle seat 103 and the actuation assembly 304 needs to be located within the sleeve structure 401. After separating from the sleeve structure 401, the needle seat 103 and the actuation assembly 304 can be disengaged. Specifically, pulling the sleeve structure 401 proximally drives the needle seat 103 to move proximally, so that the actuation assembly 304 can also move proximally for a certain distance until the actuation assembly 304 can no longer move proximally. At this time, a positioning member 3040 can be provided to abut against the actuation assembly 304. For example, the positioning member 3040 within the handle housing 10 axially abuts against the convex portion 10220 of the first rack 1022 to control that the actuation assembly 304 cannot move too much proximally, and the actuation assembly 304 separates from the sleeve structure 401, thereby disengaging the needle seat 103 and the actuation assembly 304. In this embodiment, the above-mentioned convex portion 22 and concave portion 33 can also be provided. At this time, the convex portion 22 or the concave portion 33 can be an elastic structure. When pulling the sleeve structure housing 13 proximally, the sleeve structure 401 drives the needle seat 103 to move proximally, and the needle seat 103 drives the actuation assembly 304 to move proximally. Continuing to pull the sleeve structure housing 13 proximally until the connection position between the needle seat 103 and the actuation assembly 304 separates from the sleeve structure 401. Due to the provision of the convex portion 22 and the concave portion 33, the needle seat 103 and the actuation assembly 304 are still connected at this time. Since the convex portion 22 or the concave portion 33 is an elastic structure, further pulling the sleeve structure housing 13 proximally, during the axial pulling, the convex portion 22 can be easily separated from the concave portion 33, realizing the separation between the needle seat 103 and the actuation assembly 304. In other embodiments, the convex portion 22 and the concave portion 33 may not be provided, and only the frictional force between the actuation assembly 304 and the needle seat 103 can be used to ensure the connection between the actuation assembly 304 and the needle seat 103. It can be understood that a rough surface can be provided on the contact surface of the actuation assembly 304 or / and the needle seat 103.

[0090] In one embodiment, referring to Figure 18a 、 18bWith reference to FIGS. 18c, the suturing device 100 further includes a thread cutter 200. The thread cutter 200 is disposed on the suturing device 100. The thread cutter 200 includes a holding portion 201 and a cutting portion 202 that are connected to each other. The suture 5 passes through the cutting portion 202. By pulling the holding portion 201, the suture 5 is brought into contact with the cutting portion 202 to cut the suture 5. In this embodiment, the thread cutter 200 is disposed in the handle 1. The holding portion 201 is disposed within the handle housing 10, and the cutting portion 202 is disposed outside the handle housing 10. When the suture needle 3 drives the suture 5 to be drawn out, to prevent the suture 5 from being too long, the suture 5 remaining outside the body can be cut short. A strip-shaped hole 2020 is formed in the cutting portion 202, and a blade 2023 is disposed on the inner wall of the strip-shaped hole 2020.

[0091] In one embodiment, in combination with Figure 3 、 19a 、19b and 19c, the suturing device 100 further includes a thread reel 300. The suture 5 is wound around the thread reel 300. By rotating the thread reel 300, the suture 5 is released. The first control member 9 controls the fixing or loosening of the thread reel 300. The thread reel 300 has a fixed state and a loosened state, and the first control member 9 has an initial state and a locked state.

[0092] Referring to Figure 19a , when the first control member 9 is in the initial state, the thread reel 300 is in the fixed state; referring to Figure 19b , when the first control member 9 is in the locked state, the thread reel 300 is in the loosened state. Among them, the suture 5 is wound around the thread reel 300. A part of the suture 5 is wound around the thread reel 300, and another part of the suture 5 extends along the sheath tube 2 toward the suturing arm 4, so that at least one end of the suture 5 is connected to the suturing arm 4. In one embodiment, after the suture 5 is folded in half, both ends of the suture are connected to the suturing arm 4, and the folding position of the suture 5 is located on the thread reel 300. In another embodiment, one end of the suture 5 is connected to the suturing arm 4, and the other end of the suture 5 is located on the thread reel 300.

[0093] Among them, in one embodiment, referring again to Figure 19c, the thread spool 300 includes an upper convex ring 300a, a lower convex ring 300b, a thread winding portion 300c, and a separator 300d. The thread winding portion 300c is located between the upper convex ring 300a and the lower convex ring 300b. The upper convex ring 300a and the lower convex ring 300b are used to limit the position where the suture 5 is wound. The lower convex ring 300b can also be used to cooperate with the first control member 9 to fix or relax the thread spool 300 as described in the above embodiments. A damping structure is further provided on the lower convex ring 300b. For example, the outer surface of the lower convex ring 300b is set as a polyhedral surface 300b1 to increase the tightness of the cooperation between the lower convex ring 300b and the first control member 9. In addition, the separator 300d can be used to separate the thread winding portion 300c from the lower convex ring 300b to prevent the release of the suture 5 on the thread winding portion 300c from being affected when the lower convex ring 300b cooperates with the first control member 9. In another embodiment, referring to Figure 21 , the separator 300d may not be provided.

[0094] Referring to Figure 19c , a thread hooking member 3001 is further provided on the thread spool 300. The thread hooking member 3001 can be provided at any one or more positions on the upper convex ring 300a, the lower convex ring 300b, the thread winding portion 300c, and the separator 300d. When the suture 5 is folded in half, both ends of the suture 5 are connected to the suture arm 4. The folding position 501 of the suture 5 is located on the thread spool 300. At this time, in order to facilitate the winding of the folded suture 5 onto the thread spool 300, first hook the folding position 501 of the suture 5 on the thread hooking member 3001, and then start from the folding position 501 of the suture 5 hooked on the thread hooking member 3001, and then wind the folded suture 5 onto the thread spool 300 to complete the winding of the suture 5. Then, the other part of the suture 5 passes through the thread passing hole 502 on the handle housing 10 (referring to Figure 20 ), and then extends along the sheath 20 to the suture arm 4 and is connected to the suture arm 4. In this embodiment, the thread hooking member 3001 is a small convex block 3001a. Specifically, a small convex block 3001a is cut out on the upper convex ring 300a, and the small convex block 3001a is spaced from other parts of the upper convex ring 300a. In other embodiments, the thread hooking member 3001 can be a hook-shaped structure, a rod-shaped structure, etc. on or additionally installed on the thread spool 300 as long as it can hook the folding position 501 of the suture 5.

[0095] In this embodiment, the first control member 9 can also be used to control the conversion between the conveying state and the deployed state of the suture arm 4. For the specific control process, refer to the foregoing embodiment. When the first control member 9 is in the initial state, the suture arm 4 is in the conveying state and the spool 300 is in the fixed state; when the first control member 9 is in the locked state, the suture arm 4 is in the deployed state and the spool 300 is in the relaxed state. In other embodiments, the first control member 9 can only be used to control the fixing and relaxation of the spool 300. The suture arm 4 can be controlled by other components, or a protective structure is covered outside the suture arm 4. The suture arm 4 is always in the deployed state and does not need to control the state of the suture arm 4. Just remove the protective structure when reaching the target position.

[0096] In this embodiment, by providing the first control member 9 having an initial state and a locked state, the first control member 9 controls the conversion between the fixed state and the relaxed state of the spool 300, so as to prevent the spool 300 from being always in the relaxed state and releasing too much suture thread 5. Too much suture thread 5 is prone to accumulate and knot, and it is also easy to interfere with other operations of the suture device 100. When it is necessary to relax the spool 300, the operability and controllability are stronger.

[0097] In one embodiment, refer to Figure 19a and 19b , the first control member 9 includes a main body portion 92. The main body portion 92 includes a first main body member 921 and a second main body member 922. The first main body member 921 and the second main body member 922 are arranged opposite to each other. The spool 300 is arranged between the first main body member 921 and the second main body member 922. The first main body member 921 has a first main body inner wall 9210 on the side close to the spool 300, and the second main body member 922 has a second main body inner wall 9220 on the side close to the spool 300. The position where the spool 300 is arranged between the first main body member 921 and the second main body member 922 is the first position P. At the first position P, when the first control member 9 is in the initial state, the distance between the first main body inner wall 9210 and the second main body inner wall 9220 is smaller than the distance between the first main body inner wall 9210 and the second main body inner wall 9220 when the first control member 9 is in the locked state, so as to realize the fixing and relaxation of the spool 300 in the radial direction of the spool 300. When the distance between the first main body inner wall 9210 and the second main body inner wall 9220 is small, it can be used to clamp the spool 300 and the spool 300 remains in the fixed state; when the distance between the first main body inner wall 9210 and the second main body inner wall 9220 is large, it can be used to relax the spool 300 and the spool 300 remains in the relaxed state.

[0098] In this embodiment, by providing recesses 9211 at some positions on the inner wall 9210 of the first main body member, the distance between the inner wall 9210 of the first main body member and the inner wall 9220 of the second main body member is increased. When the first control member 9 is in the initial state, at the first position P, the part of the inner wall 9210 of the first main body member without the recess 9211 abuts against the wire reel 300; when the first control member 9 is in the locked state, at the first position P, the part of the inner wall 9210 of the first main body member with the recess 9211 abuts against the wire reel 300. In other embodiments, the inner wall 9220 of the second main body member may also be provided with recesses simultaneously, or only the inner wall 9220 of the second main body member is provided with recesses. In other embodiments, the overall thickness of the first main body member 921 / second main body member 922 is uniform without recesses, as long as the distance between the first main body member 921 and the second main body member 922 decreases when the first control member 9 is in the initial state and the distance between the first main body member 921 and the second main body member 922 increases when the first control member 9 is in the locked state at the first position P.

[0099] In this embodiment, operating the first operation portion 91 drives the interconnected first main body member 921 and second main body member 922 to rotate. In other embodiments, by providing different operation portions, one of the first main body member 921 and the second main body member 922 can be rotated, and the wire reel 300 is fixed or relaxed by changing the distance between the side walls of the two main body members. In other embodiments, the operation portion may not be provided, and the first main body member 921 or / and the second main body member 922 can be directly rotated.

[0100] Combined with Figure 3 Figure 19 and Figure 20 , in one embodiment, the wire reel 300 can be provided outside the handle housing 10, and the main body portion 92 is provided inside the handle housing 10. At the first position P, an opening 1011 is provided on the handle housing 10, and the inner wall 9210 of the first main body member can abut against the wire reel 300 through this opening 1011. It can be understood that at the first position P, another opening 1011 can also be provided on the handle housing 10, and the inner wall 9220 of the second main body member can abut against the wire reel 300 through this opening 1011. Refer to Figure 21 Figure 22, Figure 23, in one embodiment, the suturing device 100 further includes a fixed cover 330, and the fixed cover 330 covers the outside of the wire reel 300. Refer to Figure 23a And Figure 23b , when the first control member 9 is in the initial state, the first control member 9 abuts against one end of the wire reel 300, and the other end of the wire reel 300 is fixed to the fixed cover 330; refer to Figure 23c And Figure 23d, when the first control member 9 is in the locked state, the other end of the spool 300 is disengaged from the fixed cover 300. With this arrangement, it is possible to fix and release the spool 300 in the height direction of the spool 300. In this embodiment, the fixed cover 330 is fixedly connected to the handle housing 10 to keep the fixed cover 330 fixed.

[0101] In this embodiment, the first control member 9 includes an ejecting member 910. One end of the ejecting member 910 is provided with an ejecting portion 910a, and the first control member 9 is rotatable. When the first control member 9 is in the initial state, the ejecting portion 910a approaches one end of the spool 300 and abuts against the spool 300, thereby fixing the spool 300; when the first control member 9 rotates to the locked state, the ejecting portion 910a moves away from one end of the spool 300, thereby releasing the spool 300.

[0102] Further, the suturing device 100 further includes an elastic member 311. Both ends of the elastic member 311 are respectively connected to the fixed cover 330 and the spool 300. When the first control member 9 is in the initial state, the ejecting portion 910a approaches one end of the spool 300 and abuts against the spool 300, thereby fixing the spool 300. At this time, the elastic member 311 is compressed and stores elastic potential energy; when the first control member 9 rotates to the locked state, the ejecting portion 910a moves away from one end of the spool 300, and the compressed elastic member 311 releases elastic potential energy. This elastic potential energy acts on the spool 300, accelerating the separation of the spool 300 from the fixed cover 330, thereby accelerating the release of the spool 300.

[0103] Further, one end of the spool 300 is provided with a first fixing portion 111, and the fixed cover 330 is provided with a second fixing portion 112. One of the first fixing portion 111 and the second fixing portion 112 is a groove, and the other is a convex block. The convex block is connected to the groove, thereby improving the fixing performance between the spool 300 and the fixed cover 330.

[0104] In one embodiment, the fixing and releasing of the spool 300 can be achieved in both the radial direction of the spool 300 and the height direction of the spool 300 in the above manner. Specifically, it includes but is not limited to the following setting methods to achieve: the ejecting member 910 can be provided on the main body portion 92. In other embodiments, it is possible to choose to achieve the fixing and releasing of the spool 300 in either the radial direction of the spool 300 or the height direction of the spool 300.

[0105] Referring again to Figure 21 , at least a part of the spool 300 is disposed outside the handle housing 10. A first post 312 is provided on the handle housing 10. The spool 300 is inserted into the first post 312, and the spool 300 rotates around the first post 312 to release the suture 5.

[0106] Combined with Figure 21 andFigure 24 One end of the spool 300 close to the handle housing 10 is provided with an opening 313. A first damping structure 314 is arranged on the inner wall of the spool 300, that is, the first damping structure 314 is arranged on the inner wall around the opening 313. The handle housing 10 is provided with a second damping structure 315 that cooperates with the first damping structure 314. As the spool 300 rotates, the first damping structure 314 moves relative to the second damping structure 315, slowing down the rotation speed of the spool 300. In other embodiments, the first damping structure 314 is arranged on the outer wall of one end of the spool 300 close to the handle housing 10, and the handle housing 10 is provided with a second damping structure 315 that cooperates with the first damping structure 314.

[0107] During the operation, when the distal end of the suture needle 3 is connected to the suture arm 4 and at least one end of the suture thread 5 on the suture arm 4 is drawn out, and then the suture needle 3 is displaced, it will drive the displacement of the suture thread 5, and the suture thread 5 drives the spool 300 to rotate to release the suture thread 5 wound on the spool 300. Since the rotation of the spool 300 has inertia, the spool 300 is likely to rotate too fast, resulting in excessive release of the suture thread 5 wound on the spool. The excessively released suture thread is likely to accumulate and knot, and it is also likely to interfere with other operations of the suture device 100. Therefore, it is necessary to slow down the rotation speed of the spool 300 so that a reasonable amount of suture thread 5 can be released.

[0108] See Figure 25a Figure 26 and Figure 27 In one embodiment, the handle 1 further includes a receiving structure 122. The receiving structure 122 is fixedly connected to the sheath 2. The receiving structure 122 includes a first part 1221. The first part 1221 abuts against the handle housing 10. The first part 1221 is provided with a first mating structure 1222, and the handle housing 10 is provided with a second mating structure 1223. One of the first mating structure 1222 and the second mating structure 1223 is at least one convex block structure 1221a, and the other of the first mating structure 1222 and the second mating structure 1223 is a plurality of concave part structures 1221b. The plurality of concave part structures 1221b are arranged circumferentially. By rotating the receiving structure 122, the receiving structure 122 moves circumferentially relative to the handle housing 10, so that a convex block structure 1221a moves sequentially in the plurality of concave part structures 1221b.

[0109] See Figure 27, in this embodiment, by providing a receiving structure 122 which is connected to the sheath tube 2, rotating the receiving structure 122, the receiving structure 122 moves circumferentially relative to the handle housing 10. After the sheath tube is delivered into the body, by adjusting the circumferential relative position between the receiving structure 122 and the handle housing 10, the sheath tube 2 can be rotated to adjust the circumferential position of the sheath tube 2, more flexibly adapting to the internal environment of the body, and at the same time, other parts of the handle 1 can be kept stationary, facilitating the operation of other parts on the handle 1. In addition, by respectively providing a first mating structure 1222 on the first part 1221 of the receiving structure 122 and a second mating structure 1223 on the handle housing 10, one of the first mating structure 1222 and the second mating structure 1223 is at least one convex block structure 1221a, and the other of the first mating structure 1222 and the second mating structure 1223 is a plurality of concave structures 1221b. The plurality of concave structures 1221b are arranged circumferentially. Rotating the receiving structure 122, the receiving structure 122 moves circumferentially relative to the handle housing 10, causing a convex block structure 1221a to move sequentially among the plurality of concave structures 1221b, enabling the angle of circumferential rotation of the receiving structure 122 to be quantitatively controlled during the rotation process, so as to more precisely control the angle of circumferential rotation of the sheath tube 2, improving the accuracy of the surgical operation process and the surgical success rate. In this embodiment, the distal end of the sheath tube 2 has a bent portion or does not have a bent portion. In Figure 27 , the first mating structure 1222 is a concave structure 1221b, and the second mating structure 1223 is a convex block structure 1221a; referring to Figure 28 , in another embodiment, the first mating structure 1222 is a convex block structure 1221a, and it can be understood that the second mating structure 1223 is a concave structure 1221b.

[0110] In one embodiment, the concave structure 1221b includes a first concave portion 1221b1 and a second concave portion 1221b2 which are connected to each other. The convex block structure 1221a moves from the first concave portion 1221b1 to the second concave portion 1221b2 or from the second concave portion 1221b2 to the first concave portion 1221b1, driving the sheath tube 2 to rotate circumferentially clockwise or counterclockwise relative to the handle housing 10 by a first angle e. In this embodiment, by being able to rotate clockwise or counterclockwise, the angle of rotation of the sheath tube 2 can be adjusted more precisely, facilitating reversible adjustment or correction to a suitable angle during the surgical process when rotating in one direction is excessive.

[0111] In one embodiment, the receiving structure 122 further includes a second portion 1224. The second portion 1224 is fixedly connected to the sheath 2. The first portion 1221 is disposed on the outer surface of the second portion 1224, facilitating the connection between the receiving structure 122 and the sheath 2 and not affecting the cooperation between the receiving structure 122 and the handle housing 10. Specifically, at least a part of the second portion 1224 penetrates into the handle housing 10. The proximal end of the first portion 1221 abuts against the distal end of the handle housing 10. A first mating structure 1222 is provided at the proximal end of the first portion 1221, and a second mating structure 1223 is provided at the distal end of the handle housing 10. In other embodiments, the receiving structure 122 may not include the second portion 1224 and only include the first portion 1221. One end of the first portion 1221 can be connected to the sheath 2, and the other end of the first portion 1221 cooperates with the handle housing 10.

[0112] See Figure 25a and Figure 25b , in one embodiment, the handle 1 further includes a knob 123. The knob 123 is sleeved and fixed on the receiving structure 122, facilitating the rotation of the receiving structure 122 through the knob 123. In other embodiments, the knob 123 may not be included, and the receiving structure 122 can be directly rotated.

[0113] The knob 123 is provided with a knob stop 1231, and the handle housing 10 is provided with a housing stop 1232. The knob 123 is sleeved on the receiving structure 122. When the knob 123 is rotated in the first direction Q, the knob stop 1231 and the housing stop 1232 are circumferentially stopped against each other, preventing the knob 123 from continuing to rotate in the first direction Q. The first direction Q can be a clockwise or counterclockwise direction.

[0114] The knob stop 1231 includes a first knob stop 1231a and a second knob stop 1231b, and the housing stop 1232 moves between the first knob stop 1231a and the second knob stop 1231b; or, the housing stop 1232 includes a first housing stop 1232a and a second housing stop 1232b, and the knob stop 1231 moves between the first housing stop 1232a and the second housing stop 1232b. With such a setting, the circumferential rotation between the knob stop 1231 and the housing stop 1232 can be controlled within a certain range in the entire circumference, so that the knob stop 1231 cannot rotate relative to the housing stop 1232 for a full circle, that is, the knob 123 rotates relative to the handle housing 10 within a certain range in the entire circumference, thereby controlling the circumferential rotation angle of the sheath 2.

[0115] In another embodiment, the knob 123 has an initial state. The knob 123 is provided with a first positioning member 1233, and the receiving structure 122 is provided with a second positioning member 1234. When the knob 123 and the receiving structure 122 are connected to each other, the first positioning member 1233 and the second positioning member 1234 are connected and fixed to each other, so that the knob 123 is in the initial state when it cooperates with the handle housing 10. During the installation process, the receiving structure 122 can be connected to the handle housing 10, and then the knob 123 can be connected to the receiving structure 122 through the cooperation of the first positioning member 1233 and the second positioning member 1234. Therefore, by controlling the initial connection position of the knob 123 and the receiving structure 122, the initial connection position of the knob stopper and the handle housing 10 can be controlled, thereby controlling the circumferential distance between the knob stopper 1231 and the housing stopper 1232, and further controlling the angular range of rotation of the knob 123, and further accurately controlling the angular range of circumferential rotation of the sheath tube 2. In other embodiments, a first knob stopper 1231a, a second knob stopper 1231b, a first positioning member 1233 and a second positioning member 1234 can be provided simultaneously, or a first housing stopper 1232a, a second housing stopper 1232b, a first positioning member 1233 and a second positioning member 1234 can be provided simultaneously, so as to more accurately control the angular range of circumferential rotation of the sheath tube 2.

[0116] In another embodiment, it can be understood that the stopper can also be provided on the receiving structure 122. Specifically, it can be understood that the receiving structure 122 can be provided with a receiving structure stopper, and the handle housing 10 is provided with a housing stopper 1232. When the knob 123 is rotated in the first direction, the receiving structure stopper and the housing stopper 1232 are circumferentially stopped against each other, preventing the receiving structure from continuing to rotate in the first direction.

[0117] See Figure 27 , in order to better fix the receiving structure 122 and the handle housing 10 together, fixing elements 1225 and 1226 are respectively provided on the receiving structure 122 and the handle housing 10. The fixing element 1225 of the receiving structure 122 is a groove structure, and the fixing element 1226 of the handle housing 10 is a convex block structure, and the groove structure and the convex block structure are connected in cooperation with each other. See Figure 28 , in one embodiment, the fixing element 1225 of the receiving structure 122 is a convex block structure, and the fixing element 1226 of the handle housing 10 is a groove structure, and the groove structure and the convex block structure are connected in cooperation with each other.

[0118] In the present embodiment, in the embodiment having the receiving structure 122, the receiving structure 122 can be applied to the suturing device 100, and it can be understood that it can also be applied to any conveying device. See Figure 1 , the conveying device 1000 includes a handle 1 and a sheath tube 2 that are connected to each other.

[0119] Taking the closure of patent foramen ovale with the suture device 100 in this embodiment as an example, the number of suture needles 3 is two, namely the first suture needle 31 and the second suture needle 32. Refer to Figure 29a , both ends 5a and 5b of the suture thread 5 are located on both sides of the suture arm 4, and the middle part 5c of the suture thread 5 extends proximally along the sheath tube 2 until it can be wound around the spool 300. The general operation process may be: delivering the suture device 100 to the target position along the guide wire, the distal end of the suture device 100 passes through the patent foramen ovale, and then the suture arm 4 is deployed. Both sides of the suture arm 4 respectively abut against the septum primum 600 and the septum secundum 700 at the position of the patent foramen ovale. Then refer to Figure 29b , extending the first suture needle 31 through the septum primum 600 and connecting it to one side of the suture arm 4, thereby pulling out one end 5a of the suture thread 5 from the suture arm 4, extending the second suture needle 32 through the septum secundum 700 and connecting it to the other side of the suture arm 4, thereby pulling out the other end 5b of the suture thread 5 from the suture arm 4. The first suture needle 31 and the second suture needle 32 respectively carry the two ends 5a, 5b of the suture thread 5 and slowly retract proximally into the sheath tube 2 until they are retracted outside the body. At the same time, the middle part 5c of the suture thread 5 is slowly disengaged from the spool 300 and then slowly moves distally until it reaches the position of the septum primum and the septum secundum (refer to Figure 29c ), and finally, a knotter is sent into the body along the two ends 5a, 5b of the suture thread 5, and the redundant part of the suture thread 5 is cut to complete the closure of the patent foramen ovale. In order to make the figure simpler and easier to understand, in Figure 29a , 29b and 29c, the first suture needle 31, the second suture needle 32, the suture arm 4, the sheath tube 2 and the spool 300 are not drawn. For the relevant structures, please refer to the foregoing embodiments.

[0120] 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 those skilled in the art within the technical scope disclosed by the present invention should be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention should be subject to the protection scope of the claims.

Claims

1. A suturing device, comprising a suture needle, a suture arm and a suture thread, at least one end of the suture thread being located on the suture arm, the distal end of the suture needle being connectable to the suture arm to withdraw at least one end of the suture thread from the suture arm, characterized in that, The suture device further includes a first control member and a spool. A part of the suture is wound around the spool, and the other part of the suture extends towards the suture arm, so that at least one end of the suture is connected to the suture arm. The first control member can control the fixation or relaxation of the spool. The spool has a fixed state and a relaxed state. The first control member has an initial state and a locked state. When the first control member is in the initial state, the spool is in the fixed state. When the first control member is in the locked state, the spool is in the relaxed state. The spool in the relaxed state can release the suture.

2. The suture device according to claim 1, characterized in that, The first control member includes a main body portion. The main body portion includes a first main body member and a second main body member. The first main body member and the second main body member are disposed opposite to each other. The spool is disposed between the first main body member and the second main body member. The first main body member has a first inner wall on the side close to the spool, and the second main body member has a second inner wall on the side close to the spool. The position where the spool is disposed between the first main body member and the second main body member is the first position. At the first position, the distance between the first inner wall of the first main body member and the second inner wall of the second main body member when the first control member is in the initial state is smaller than the distance between the first inner wall of the first main body member and the second inner wall of the second main body member when the first control member is in the locked state.

3. The suture device according to claim 2, wherein, At least one of the first main body member and the second main body member is rotatable. By rotating the first main body member and / or the second main body member, the spool can be fixed or relaxed.

4. The suture device according to claim 1, wherein The suture device further includes a fixing cover, and the fixing cover covers the outside of the spool. When the first control member is in the initial state, the first control member abuts against one end of the spool, and the other end of the spool is fixed to the fixing cover. When the first control member is in the locked state, the other end of the spool is disengaged from the fixing cover.

5. The suturing device according to claim 4, wherein The first control member includes an ejecting member. One end of the ejecting member is provided with an ejecting portion. When the first control member is in the initial state, the ejecting portion is close to and abuts against one end of the spool. When the first control member rotates to the locked state, the ejecting portion is away from one end of the spool.

6. The suture device according to claim 4, wherein The suture device further includes an elastic member, and both ends of the elastic member are respectively connected to the fixing cover and the spool.

7. The suture device according to claim 4, wherein The other end of the spool is provided with a first fixing portion, and the fixing cover is provided with a second fixing portion. One of the first fixing portion and the second fixing portion is a groove, and the other is a protrusion, and the protrusion is connected to the groove.

8. The suturing device according to claim 2, wherein The suture device further includes a fixing cover, and the fixing cover covers the outside of the spool. When the first control member is in the initial state, the first control member abuts against one end of the spool, and the other end of the spool is fixed to the fixing cover. When the first control member is in the locked state, the other end of the spool is disengaged from the fixing cover.

9. The suture device according to claim 1, wherein The suture device further includes a handle, the first control member and the thread spool are arranged on the handle, the handle includes a handle housing, at least part of the thread spool is arranged outside the handle housing, a first post is arranged on the handle housing, the thread spool is inserted into the first post, and the thread spool can rotate around the first post.

10. The suturing device according to claim 9, wherein, A first damping structure is arranged at one end of the thread spool close to the handle housing, and the handle housing is provided with a second damping structure cooperating with the first damping structure. As the thread spool rotates, the first damping structure moves relative to the second damping structure to slow down the rotation speed of the thread spool.

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