CN120227087A

CN120227087A - Suture device

Info

Publication number: CN120227087A
Application number: CN202311844438.3A
Authority: CN
Inventors: 汤麟
Original assignee: Shenzhen Bihe Medical Co ltd
Current assignee: Shenzhen Bihe Medical Co ltd
Priority date: 2023-12-28
Filing date: 2023-12-28
Publication date: 2025-07-01
Also published as: WO2025139995A1

Abstract

The present invention discloses a suturing device, which also includes an actuating assembly, a needle seat, a first support member and a second support member. The first support member is movably connected to the needle seat, the needle seat is connected to the suturing needle, the actuating assembly and the needle seat are detachably connected in a direction perpendicular to the axial direction, when the suturing needle is extended, the distal end of the suturing needle can be connected to the suturing arm, when the actuating assembly and the needle seat are connected, the first support member is located outside the needle seat, the second support member is located outside the actuating assembly, a straight line in the axial direction where the first support member is located and a straight line in the axial direction where the second support member is located are arranged relative to each other in a direction perpendicular to the axial direction, and are used to support the actuating assembly and the needle seat in a direction perpendicular to the axial direction, the mutually connected actuating assembly and the needle seat can move axially between the first support member and the second support member, when the first support member moves toward the proximal end, the first support member drives the needle seat to move toward the proximal end, and the needle seat drives the actuating assembly to move toward the proximal end until the actuating assembly and the needle seat are disengaged.

Description

Suturing device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a suturing device.

Background

Patent Foramen Ovale (PFO), which has been considered to be benign and harmless in many cases, has been a common cause for experts in recent clinical studies, and is one of causes of cerebral apoplexy, migraine, contradictory embolism, etc. which are unknown causes. Thus, PFO occlusion or closure is required.

In the prior art, the treatment purpose is achieved by placing a plugging device to plug the oval foramen. The existing plugging device generally comprises an integrated plugging main body consisting of two plugging discs, wherein the two plugging discs are respectively positioned at two sides of the membrane wall so as to realize the functions of fixing and plugging the plugging device relative to the membrane wall, contact friction exists between the two plugging discs and the membrane wall, the position of the plugging device relative to the membrane wall is difficult to adjust, and the plugging effect of the plugging device on the defect part of the membrane wall is influenced. In addition, the distance between the two plugging discs of the integrated plugging main body is constant and cannot be adjusted, if the membrane wall is thin, the plugging device may not be firmly plugged, and if the membrane wall is thick, excessive extrusion on the membrane wall may be caused to cause damage, and the occurrence risk of complications is increased.

Disclosure of Invention

In order to overcome the above-described drawbacks of the prior art, the present application provides an interventional suturing device.

The invention solves the technical problems by the following technical proposal:

An embodiment of the present invention provides a suturing device comprising a suturing needle, a suturing arm and a suture, at least one end of the suture being located on the suturing arm, a distal end of the suturing needle being connectable to the suturing arm for withdrawing the at least one end of the suture from the suturing arm, characterized in that the suturing device further comprises an actuation assembly, a hub, a first support and a second support, the first support being movably connected to the hub,

The needle seat is connected with the suture needle, the actuating component and the needle seat are detachably connected in the direction vertical to the axial direction, the actuating component controls the extension and retraction of the suture needle through the needle seat, when the suture needle extends, the distal end of the suture needle can be connected with the suture arm,

When the actuating assembly is connected with the needle seat, the first supporting piece is positioned outside the needle seat, the second supporting piece is positioned outside the actuating assembly, the straight line of the axial direction of the first supporting piece and the straight line of the axial direction of the second supporting piece are oppositely arranged in the direction vertical to the axial direction and used for supporting the actuating assembly and the needle seat in the direction vertical to the axial direction, the actuating assembly and the needle seat which are connected with each other can axially move between the first supporting piece and the second supporting piece,

When the first supporting piece moves towards the proximal end, the first supporting piece drives the needle seat to move towards the proximal end, and the needle seat drives the actuating assembly to move towards the proximal end until the actuating assembly and the needle seat are separated.

In the suturing device, after the actuating assembly is connected with the needle seat, the first supporting piece is positioned outside the needle seat, the second supporting piece is positioned outside the actuating assembly, and the straight line of the axial direction of the first supporting piece and the straight line of the axial direction of the second supporting piece are oppositely arranged in the direction vertical to the axial direction and are used for supporting the actuating assembly and the needle seat in the direction vertical to the axial direction, namely, the first supporting piece is used for supporting the needle seat, the second supporting piece is used for supporting the actuating assembly, and the first supporting piece, the needle seat, the actuating assembly and the second supporting piece are mutually supported on the same plane vertical to the axial direction, so that the four pieces are kept not separated in the direction vertical to the axial direction, but the interconnected actuating assembly and the needle seat can move axially between the first supporting piece and the second supporting piece, so that the extending and retracting of the suturing needle can be controlled without influencing the axial movement of the actuating assembly; secondly, the first supporting piece is movably connected with the needle seat, the actuating component and the needle seat are detachably connected in the direction vertical to the axial direction, when the first supporting piece moves proximally, the first supporting piece drives the needle seat to move proximally, at the moment, the first supporting piece, the needle seat, the actuating component and the second supporting piece are still mutually supported on the same plane vertical to the axial direction, even if axial displacement occurs between the four pieces, the four pieces still keep not separated in the direction vertical to the axial direction, and the needle seat can drive the actuating component to move proximally, because the actuating component controls the extension and retraction of the suture needle through the needle seat, the actuating component and the needle seat can drive the actuating component to move proximally before being separated, the interference of the actuating component on other parts of the suture device can be reduced, the needle seat is connected with the suture needle, and the actuating assembly and the needle seat can be separated, so that the suture needle with the suture thread (namely the suture needle with the suture thread which has completed the suture action in the body) can be pulled out of the body, the suture needle can be pulled out of the body, part of the suture thread connected with the suture needle can be withdrawn from the body, an operator can conveniently send the knotter into the body along the part of the suture thread withdrawn from the body, or the part of the suture thread withdrawn from the body can be directly pushed into the body after being knotted, and suture fixation is completed.

Drawings

The invention will be further described with reference to the accompanying drawings and examples, in which:

FIG. 1 is a schematic view of a suturing or delivery device according to one embodiment;

FIG. 2 is a schematic view of a portion of a suturing device or delivery device having suturing arms in an expanded state, according to one embodiment;

FIG. 3 is a schematic view of an exploded construction of a suturing or delivery device of an embodiment;

FIG. 4 is an enlarged schematic view of the portion A in FIG. 3;

FIG. 5 is a schematic view of a portion of a suturing or delivery device of an embodiment;

FIG. 6 is a schematic cross-sectional view of a portion of the suturing or delivery device having a first control member in an initial state in accordance with one embodiment;

FIG. 7 is a schematic cross-sectional view of a portion of the suturing or delivery device of an embodiment having a first control member in a locked condition;

FIG. 8a is a schematic diagram of a slider assembly 8 according to an embodiment of the present invention, FIG. 8b is a schematic diagram of an exploded structure of the slider assembly 8 according to an embodiment of the present invention;

FIG. 9 is a simplified schematic diagram illustrating a movement relationship between the first control member and the first connecting member according to an embodiment;

FIG. 10 is a simplified schematic diagram illustrating a movement relationship between a first control member and a first link according to another embodiment;

FIG. 11 is a schematic view of a portion of a suturing or delivery device of an embodiment;

FIG. 12a is a schematic cross-sectional view of a portion of a suturing or delivery device having a first control member in an initial state, and FIG. 12b is a schematic cross-sectional view of a portion of a suturing or delivery device having a first control member in a locked state;

FIG. 13 is a schematic view of a portion of a suturing device or delivery device having suturing arms in a deployed state in accordance with another embodiment;

FIG. 14 is a schematic view of a portion of a suturing or delivery device of an embodiment;

FIG. 15a is a schematic cross-sectional view of a portion of one embodiment of a suturing or delivery device at one point in time, FIG. 15b is a schematic cross-sectional view of another embodiment of a suturing or delivery device at another point in time, FIG. 15c is a schematic cross-sectional view of a portion of one embodiment of a suturing or delivery device at another point in time;

FIG. 16a is a schematic view of a portion of a suturing or delivery device from one perspective, FIG. 16b is a schematic view of a suturing or delivery device from another perspective, FIG. 16c is a schematic view of a suturing or delivery device from another perspective;

FIG. 17a is a schematic cross-sectional view of a portion of a suturing or delivery device of an embodiment, FIG. 17b is a schematic cross-sectional view of a portion of FIG. 17 a;

FIG. 18a is a schematic view of a portion of a suture device or delivery device according to one embodiment, FIG. 18b is a schematic view of a view of the thread trimmer of FIG. 18a, and FIG. 18c is a schematic view of another view of the thread trimmer of FIG. 18 a;

Fig. 19a is a schematic structural view of an embodiment of the first control member having an initial state and matching with a wire coil, fig. 19b is a schematic structural view of an embodiment of the first control member having a locking state and matching with a wire coil, and fig. 19c is a schematic structural view of an embodiment of the connection of a wire coil and a suture;

FIG. 20 is an enlarged schematic view of the portion B of FIG. 3;

FIG. 21 is an exploded view of a portion of the structure of a suturing or delivery device of an embodiment;

FIG. 22a is a schematic view of a first control member with an initial state according to an embodiment, and FIG. 22b is a schematic view of a first control member with a locked state according to an embodiment;

FIG. 23a is a schematic cross-sectional view showing a portion of the suturing or delivery device having a first control member in an initial state according to one embodiment, FIG. 23b is a schematic cross-sectional view showing the first control member in an initial state according to FIG. 23a, FIG. 23c is a schematic cross-sectional view showing a portion of the suturing or delivery device having a first control member in a locked state according to one embodiment, FIG. 23d is a schematic cross-sectional view showing the first control member in a locked state according to FIG. 23 c;

FIG. 24 is a schematic cross-sectional view of a portion of the structure of a suturing or delivery device of an embodiment;

FIG. 25a is a schematic view of a portion of a suturing or delivery device of an embodiment, FIG. 25b is a schematic view of a knob in FIG. 25 a;

FIG. 26a is a schematic view of a portion of a suturing or delivery device of an embodiment, FIG. 26b is a schematic view of a portion of FIG. 26 a;

FIG. 27 is an exploded view of a portion of the structure of a suturing or delivery device of an embodiment;

FIG. 28 is a schematic view of a receiving structure according to an embodiment;

Fig. 29a is a schematic view showing a state of a suture thread at a certain time during the suturing of an oval hole by the suturing device or the transporting device according to an embodiment, fig. 29b is a schematic view showing a state of a suture thread at a certain time during the suturing of an oval hole by the suturing device or the transporting device according to an embodiment, and fig. 29c is a schematic view showing a state of a suture thread at a certain time during the suturing of an oval hole by the suturing device or the transporting device according to an embodiment.

DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION

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

Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "includes," "including," and "having" are inclusive and therefore specify the presence of 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 groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order described or illustrated, unless an order of performance is explicitly stated. It should also be appreciated that additional or alternative steps may be used.

Although the terms first, second, third, etc. may be used herein to describe various 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 only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.

For ease of description, spatially relative terms, such as "inner," "outer," "lower," "below," "upper," "above," and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "below" may 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 herein interpreted accordingly.

It should be noted that "distal end" and "proximal end" are used as terms of orientation, which are terms commonly used in the field of interventional medical devices, where "distal end" refers to an end that is away from an operator during a surgical procedure and "proximal end" refers to an end that is near the operator during a surgical procedure. Axial refers to the direction parallel to the line connecting the distal center and the proximal center of the medical instrument, and radial refers to the direction perpendicular to the axial direction.

Suturing devices in embodiments of the present invention include, but are not limited to, those used to suture patent foramen ovale, valve edge-to-edge suture repair, chordae tendineae suture repair, vascular suturing, and the like.

Referring to fig. 1 and 2, the present embodiment provides a suturing device 100 comprising a handle 1 and a sheath 2 connected to each other. The suturing device 100 further comprises a suturing needle 3, a suturing arm 4 and a suturing thread 5, at least one end of the suturing thread 5 being locatable on the suturing arm 4, the suturing arm 4 having a mutually switched delivery state and a deployed state, in which the distal end of the suturing needle 3 is connectable to the suturing arm 4, at least one end of the suturing thread 5 being withdrawn from the suturing arm 4. A suture needle 3 and a suture 5 are provided in the sheath 2, a suture arm 4 is provided at or near the distal end of the sheath 2, and the proximal end of the suture needle 3 is provided on the handle 1. Fig. 1 shows the transport state of the suture arm 4, the suture arm 4 has not yet been deployed and the suture needle 3 has not yet been extended, and fig. 2 shows the deployment state of the suture arm 4, the suture needle 3 has been extended and the distal end of the suture needle 3 is about to be connected to the suture arm 4.

Referring to fig. 3-7, in one embodiment, the suturing device 100 further includes a first connector 6, a second connector 7, a slider assembly 8, and a first control member 9. As shown in fig. 8a and 8b, the slider assembly 8 includes a first slider 81, a second slider 82 and an elastic member 83 connected to each other, the second slider 82 and the elastic member 83 are axially disposed in the first slider 81, and the second slider 82 and the first slider 81 are relatively movable. As shown in fig. 4, 6 and 7, two ends of the first connecting piece 6 are respectively connected to the first sliding block 81 and the first control piece 9, two ends of the second connecting piece 7 are respectively connected to the suture arm 4 and the second sliding block 82, so that the first sliding block 81 is controlled to move through the first control piece 9, and the first sliding block 81 drives the second sliding block 82 to move through the elastic piece 83, so that the movement of the suture arm 4 is controlled, namely, the suture arm is switched from the conveying state to the unfolding state.

The first control member 9 has an initial state and a locked state, the first control member 9 is in the initial state in fig. 6, and the first control member 9 is in the locked state in fig. 7. In the process that the first control member 9 moves from the initial state to the locking state, the suture arm 4 is converted from the conveying state to the unfolding state, the first control member 9 drives the first sliding block 81 to axially move towards the first direction a through the first connecting piece 6 to form a first movement stroke relative to the handle shell, the first sliding block 81 drives the second sliding block 82 to axially move towards the first direction a through the elastic piece 83 to form a second movement stroke relative to the handle shell, and the first movement stroke is larger than the second movement stroke, so that the elastic piece 83 can elastically deform in the first sliding block 81.

In this embodiment, referring to fig. 2 and 4, the suture arm 4 is converted from the delivery state to the deployment state by moving the second connector 7 along the first direction a, driving the suture arm 4 to move along the sliding rail 11 on the inner wall of the sheath 2 in the first direction a, and the sheath 2 is further provided with an opening 12, so that the suture arm 4 can slowly deploy through the opening 12 during the movement until the suture arm 4 moves to abut against the inner wall of the opening 12 on the sheath 2, where in this embodiment, the first direction a is a distal-to-proximal direction. In other embodiments, the first direction a may be a proximal-to-distal direction.

It will be appreciated that, since the second slider 82 is connected to the suture arm 4 by the second connector 7, the second slider 82 moves axially in the first direction a, driving the second connector 7 and the suture arm 4 to move axially in the first direction a until the suture arm 4 moves against the inner wall of the opening 12 in the sheath 2, at which time the second connector 7 and the suture arm 4 cannot move in the first direction a any more, the suture arm 4 is in the unfolded state, and the first control member 9 can be considered to be in a pre-locking state, which is a state between the initial state and the locking state, and in the pre-locking state, the second slider 82 connected to the second connector 7 is still relatively to the housing because the second connector 7 cannot continue to move in the first direction a, that is, the second slider 82 has completed the second movement stroke, however, at which time the suture arm 4 can still be restored to the delivery state under the external force, and therefore the suture arm 4 is not in the true locking state, and the first control member 9 also reaches only the pre-locking state and does not reach the locking state. Next, if the first control member 9 is further moved in the original direction, the first connecting member 6 may be made to drive the first sliding block 81 to further move axially in the first direction a, so as to finally realize that the first movement stroke is greater than the second movement stroke, thereby causing the elastic member 83 between the first sliding block 81 and the second sliding block 82 to generate elastic deformation in the first sliding block 81. When the first control member 9 reaches the locked state, the force applied to the first sliding block 81 by the first control member 9 in the locked state, the force applied to the first sliding block 81 by the elastic member generating the elastic deformation, and the friction force applied to the first sliding block 81 by the handle housing 10 can be balanced, so that the first control member 9, the first connecting member 6, the first sliding block 81, the elastic member 83 and the second sliding block 82 can be kept stationary relative to the handle housing 10, that is, the first control member 9, the first connecting member 6, the first sliding block 81, the elastic member 83 and the second sliding block 82 can be kept relatively fixed, and the suture arm 4 can be prevented from rebounding back to the delivery state, or a certain uncertain state between the delivery state and the unfolding state, so that the relative fixation of the suture arm 4 and the handle housing 10 is realized, that is, the suture arm 4 with the unfolding state is locked by locking the first control member 9, the suture arm 4 is prevented from being uncertainly moved under the unexpected external force, so that the connection of the suture needle 3 and the suture arm 4 is facilitated, and the success rate of the surgery is improved.

It will be appreciated that the elastic member 83 may have a smaller initial compression elastic deformation before the elastic deformation is generated, the elastic member 83 having an initial elastic deformation is disposed in the first slider 81, and two ends of the elastic member are respectively connected to the first slider 81 and the second slider 82, and the initial elastic deformation is smaller, so that the static friction force of the first slider 81 and the second slider 82 cannot be counteracted, and the suture arm 4 cannot be driven to move, so that the second slider 82 and the suture arm 4 cannot be driven to move before the elastic deformation is generated, and the suture arm 4 is kept in a conveying state. In other embodiments, the elastic member 83 may be in a natural state without initial elastic deformation before the elastic deformation, and the elastic member may be located on the proximal side of the second slider or on the distal side of the second slider. In other embodiments, the elastic member 83 may have a smaller initial tensile elastic deformation before the elastic deformation is generated, at this time, the second slider may be located at 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.

In this embodiment, referring to fig. 5, the first control member 9 includes a first operating portion 91 and a main body portion 92 that are connected to each other, the first operating portion 91 is used for an operator to operate, rotating the first operating 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 when the main body portion 92 is directly rotated and locking is required, the main body portion 92 may be locked by a separate locking member or directly by hand.

Referring to fig. 9, fig. 9 is a schematic view for explaining a trajectory of the first control member 9 moving from the initial state to the locked state, wherein a connection point of the first connection member 6 to the main body 92 is 61, and a connection point of the first connection member 6 to the first slider 81 is 62. With the rotation of the main body 92, the connection point 61 of the first connecting piece 6 and the main body 92 rotates along the direction b, from 61a to 61b to 61c, the connection point 61 moves in an arc on the main body 92 to form an arc path S, and the connection point 62 of the first connecting piece 6 and the first sliding block 81 moves axially, from 62a to 62b to 62c. By the design, the arc motion can be converted into linear motion, so that the operability is stronger, and the use feeling is better.

Specifically, the circular arc path S includes a start end 61a and an end 61c, the circular arc path S further includes a transition point 61b, the transition point 61b is located between the start end 61a and the end 61c of the circular arc path S, when one end of the first connecting member 6 connected to the main body 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 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, the elastic member 83 elastically deforms to the greatest extent, but at this time, the first control member 9 does not reach the locking position, that is, does not reach the locking state, and the first control member 9 continues to move in the original direction, driving the first slider 81 to move in the opposite direction to the first direction a, at this time, the elastic deformation degree of the elastic member 83 slightly decreases until the first control member 9 reaches the locking position, at which the first control member 9 is limited or locked by other elements (such as a handle housing), so that the elastically deformed elastic member 83 cannot drive the first slider 81 to move in the opposite direction to the first direction a, guaranteeing the locking state of the first control member 9. It will be appreciated that the above-mentioned "the elastic member 83 elastically deformed applies a force to the first slider 81 to drive the first slider 81 to move in the direction opposite to the first direction a", and during this process, even if the first slider 81 undergoes a movement in the direction opposite to the first direction a for a certain distance, the suture arm 4 connected to the second slider 82 remains in the unfolded state as long as the first movement stroke is maintained to be greater than the second movement stroke, that is, the first slider 81 moves in the first direction a for a distance still greater than the second slider 82 moves in the first direction a, and at this time, the elastic deformation force of the elastic member 83 still acts on the second slider 82 in the first direction a.

In fig. 9, in the pre-locking state, the connection point of the first connecting element 6 and the main body 92 is located at the pre-locking point 61e, the pre-locking point 61e may be located at a position between the start end 61a and the transition point 61b in the circular arc path S, and during the movement of the connection point of the first connecting element 6 and the main body 92 from the start end 61a to the pre-locking point 61e, the first slider 81 moves the second slider 82 together until the second slider 82 completes the second movement stroke, so that the suture arm 4 may be moved from the delivery state to the deployment state, but the suture arm 4 may not be locked in the deployment state, and may still be moved towards the delivery state under unexpected external force, because no locking member other than the handle housing 10 is specially designed. During the movement of the connection point of the first connection member 6 and the main body 92 from the pre-locking point 61e to the final end 61c, the elastic member 83 is elastically deformed in the first slider 81 until the first control member 9 is in the locked state, and at this time, the suture arm 4 is also in the locked state and cannot move relative to the handle housing 10. The first control member 9 can thus have a locked state only when the point of connection of the first connection member 6 with the main body portion 92 is located at a position behind the predetermined locking point 61 e. It will be appreciated that the transition point 61b is located between the pre-lock point 61e and the terminus 61 c.

Referring to fig. 3 and 5, the handle 1 includes a handle housing 10, the slider assembly 8, the first connector 6, and the main body 92 are disposed in the handle housing 10, and the first operating portion 91 passes through the handle housing 10 and is disposed outside the handle housing 10, and as shown in fig. 5, when the first operating portion 91 is in the locked state, the first operating portion 91 abuts against the handle housing 10. Specifically, referring to fig. 5, 11 and 19a, the first operation portion 91 includes a first arm 911, a second arm 912 and a connection arm 913, the connection arm 913 is connected to one end of the first arm 911 and one end of the second arm 912, respectively, the other end of the first arm 911 and the other end of the second arm 912 are connected to the main body portion 92, respectively, and an operator can hold the connection arm 913 on the hand to operate the movement of the first operation portion 91, the connection arm 913 being adapted to abut against the handle housing 10.

The first control member 9 shown in fig. 7 and 9 is rotated in the direction b until the first control member 9 is rotated against the handle housing 10, and the handle housing 10 prevents the first control member 9 from being rotated further in the direction b, and the force generated by the elastic deformation of the elastic member 83 cannot rotate the first control member 9 in the direction opposite to the direction b, so that the balance of the force is achieved, and the locking of the first control member 9 is realized. In other embodiments, the way of locking the first control element 9 can also be achieved by providing a separate locking element, by means of which the connection of the locking element to the first control element 9 locks.

Referring to fig. 9 again, in this embodiment, since the locking member other than the handle housing is not separately designed to lock the first control member 9, the locking of the first control member 9 is mainly achieved by abutting the handle housing 10 against the first control member 9, and in addition, during the process of moving the first control member 9 from the initial state to the locked state when the first control member 9 is operated, the end of the first connecting member 6 connected to the first control member 9 moves in an arc shape on the first control member 9, so that when the first control member 9 is in the locked state, 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 position (e.g. 61 c) behind the transition point 61b, so that the locking performance can be ensured. If the end of the first connecting member 6 connected to the main body 92 of the first control member 9 is located at a point Q before the transition point 61b without applying an external force to the first control member 9, the elastic member 83, which is elastically deformed, generates a force F on the main body 92 of the first control member 9 through the first connecting member 6 at the point Q according to the force analysis chart, the force F has a component force F1 in the circumferential direction and in the direction opposite to the direction b, and the component force F1 can drive the end of the first connecting member 6 connected to the main body 92 of the first control member 9 to move in the direction opposite to the direction b, so that the end of the first connecting member 6 connected to the main body 92 of the first control member 9 easily returns to the starting end 61a, and therefore the point Q cannot reach the force balance, and the first control member 9 cannot reach the locked state.

Wherein the main body 92 has a center rotation point O, the main body 92 rotates around the center rotation point O, and when one end of the first connector 6 connected to the main body 92 of the first control member 9 is located at the transition point 61b, the connection point 61b of the first connector 6 to the main body 92, the connection point 62b of the first connector 6 to the first slider 81, and the center rotation point O are on the same straight line.

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

In fig. 9, the first connecting member 6 is linear as a whole. In one embodiment, referring to fig. 10, the first connector 6 may be generally in the shape of a fold line, and in other embodiments, the first connector 6 may be generally in the shape of a curve.

In an embodiment, two ends of the first connecting piece 6 are respectively pivotally connected with the first control piece 9 and the first sliding block 81, so that a more flexible connection manner is provided, and the first connecting piece 6 is beneficial to connecting with the first control piece 9 and the first sliding block 81 at different angles, so that the relative movement among the first control piece 9, the first connecting piece 6 and the first sliding block 81 is convenient.

In an embodiment, referring again to fig. 7 and 8b, the second slider 82 is disposed in the first slider 81, the fixing post 84 is disposed in the second slider 82, the proximal end of the second connector 7 first penetrates into the first slider 81, then enters into the second slider 82, passes through the fixing post 84, then penetrates out of the second slider 82, winds the second connector 7 around the fixing post 84 by rotating the fixing post 84, and finally fixes the fixing post 84 with the screw 85, thereby fixing the second connector 7 to the second slider 82.

In an embodiment, the first direction a is a direction in which the first end moves toward the second end, referring to fig. 6 and 7, and in this embodiment, the first direction a is a direction from the distal end to the proximal end, wherein the elastic member 83 is a compression elastic member, and the elastic member 83 is disposed in the first slider 81 at a side near the distal end. A compression-type elastic member (e.g., a compression spring) is understood to be a member that compresses the elastic member, shortens the elastic member, and deforms the elastic member, and has a tendency to recover deformation, thereby enabling storage of deformation energy. In another embodiment, the elastic member 83 is a tensile elastic member, and the elastic member 83 is disposed on a side near the proximal end in the first slider 81. A tensile elastic member (e.g., a tension spring) is understood to be an elastic member that is stretched to deform the elastic member, and has a tendency to recover deformation, thereby being capable of storing deformation energy. It will be appreciated that the first direction a may also be a direction from the proximal end to the distal end.

Suturing device 100 includes a first control assembly (or suturing arm control assembly) 101 and a second control assembly (or hub control assembly) 102. Referring to fig. 6 and 7, a first control assembly 101 comprises the first connector 6, the second connector 7, the slider assembly 8 and the first control member 9, the first control assembly 101 is used for controlling the suture arm 4 to be mutually converted in a delivery state and an unfolding state, and referring to fig. 2, 3, 11 and 12, a second control assembly 102 is connected with the suture needle 3 and used for controlling the extension and retraction of the suture needle 3, and when the suture needle 3 is extended, the distal end of the suture needle 3 can be connected with the suture arm 4.

The first control member 9 has a through hole 93 passing through it axially, when the first control member 9 is in a locked state, the second control member 102 penetrates through the through hole 93 to perform axial movement, and when the first control member 9 is in an initial state, the second control member 102 is prevented from penetrating through the through hole 93 to restrict the second control member 102 from performing axial movement. The arrangement is that the suture needle 3 can be stretched out to be connected with the suture arm 4 only when the suture arm 4 is in a stretched state, so that the suture arm 4 can be ensured to be stretched out firstly and then the suture needle 3 can be stretched out, and the suture needle 3 is prevented from being damaged by the suture needle 3 due to the fact that the suture arm 4 is not stretched out and the suture needle 3 is stretched out.

In this embodiment, the first control member 9 is disposed at the distal end side of the second control member 102, and the second control member 102 drives the suture needle 3 to extend distally, so that the distal end of the suture needle 3 extends from the proximal end of the suture arm 4 after passing through the through hole 93, and further at least one end of the suture 5 is pulled out from the suture arm 4.

In another embodiment, referring to fig. 13, the distal end of the suture needle 3 can be bound by the sheath 2 in the delivery state, the second control component 102 drives the suture needle 3 to move proximally to the position of the opening 12, the distal end portion of the suture needle 3 stretches out to take the everted shape, the second control component 102 continues to drive the suture needle 3 to move proximally until the suture needle 3 is connected with the suture arm 4, the second control component 102 further drives the suture needle 3 to move proximally, the distal end of the suture needle 3 withdraws in the direction C and is separated from the suture arm 4, at least one end of the suture 5 on the suture arm 4 is pulled out until the distal end of the suture needle 3 enters the sheath 2 again, and the distal end portion of the everted suture needle 3 is straightened. It will be appreciated that in this embodiment, the first control member 9 is disposed on the proximal side of the second control member 102, and that the proximal end of the second control member 102 is able to pass through the through-hole 93 for axial movement only when the first control member 9 is in the locked condition.

Referring to fig. 3, 12a, 12b and 14, the second control assembly 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 engaged with each other, the needle holder 103 is connected with the suture needle 3 and the first rack 1022, the first gear 1021 is rotated, the needle holder 103 is driven to axially move by the first rack 1022 to control the extension and retraction of the suture needle 3, and when the suture needle 3 extends, the distal end of the suture needle 3 is connected with the suture arm 4, thereby realizing the control of the precise movement of the suture needle 3 and improving the operability. Further, the second control assembly 102 further includes a second operation portion (or gear operation portion) 1023, where the second operation portion 1023 is connected to the first gear 1021, and the second operation portion 1023 is operated to rotate the first gear 1021.

In one embodiment, first rack 1022 includes an engagement section 10221 and a connection section 10222, engagement section 10221 and connection section 10222 being axially coupled, engagement section 10221 being mated to first gear 1021, connection section 10222 being coupled to the proximal end of suture needle 3. Wherein the engagement section 10221 is a section of a groove structure on the first rack 1022, and the first gear 1021 is limited to move in the groove structure.

In one embodiment, the first rack 1022 includes a penetrating section 10223 and an engaging section 10221, the penetrating section 10223 is axially connected to the engaging section 10221, the engaging section 10221 is engaged with the first gear 1021, and the penetrating section 10223 is configured to penetrate the through hole 93 of the first control member 9 in fig. 12.

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.

In an embodiment, referring to fig. 2, 3, 13 and 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 with the first needle holder 1031, the second suture needle 32 is connected with the second needle holder 1032, the second control assembly 102 further includes a second gear 2021 and a second rack 2022 which are matched with each other, the first gear 1021 is rotated, the first needle holder 1031 is driven by the first rack 1022 to axially move to control the extension and retraction of the first suture needle 31, the second gear 2021 is rotated, the second needle holder 1032 is driven by the second rack 2022 to axially move to control the extension and retraction of the second suture needle 32, so that independent operations can be respectively performed on the first suture needle 31 and the second suture needle 32, and the operability is improved.

Referring to fig. 3 and 14, the first rack 1022 and the second rack 2022 are disposed in the handle housing 10 side by side, the first gear 1021 and the second gear 2021 are connected by a link 3021, the link 3021 passes through the first gear 1021 and the second gear 2021, both ends of the link 3021 are fixed to the handle housing 10, and the first gear 1021 and the second gear 2021 rotate around the link 3021, respectively.

In an embodiment, referring to fig. 15a, 15b and 15c, suturing device 100 further comprises an actuation assembly 304, a first support 301 and a second support 302, the first support 301 being movably connected to hub 103, the actuation assembly 304 being adapted to control the extension and retraction of the suture needle 3, the distal end of the suture needle 3 being connected to the suturing arm 4 when the suture needle 3 is extended, hub 103 being connected to the suture needle 3, the actuation assembly 304 and hub 103 being detachably connected in a direction perpendicular to the axial direction.

When the actuating assembly 304 and the needle holder 103 are connected, the first supporting member 301 is located outside the needle holder 103, the second supporting member 302 is located outside the actuating assembly 304, a straight line M in the axial direction of the first supporting member 301 and a straight line N in the axial direction of the second supporting member 302 are oppositely arranged in the direction perpendicular to the axial direction, the actuating assembly 304 and the needle holder 103 are supported in the direction perpendicular to the axial direction, and the interconnected actuating assembly 304 and needle holder 103 can axially move between the first supporting member 301 and the second supporting member 302. When the first supporting member 301 moves proximally, the first supporting 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 separated, and after the actuating assembly 304 and the needle holder 103 are separated, the first supporting member 301 still can drive the needle holder 103 to move proximally continuously.

In this embodiment, actuation assembly 304 may include first gear 1021 and first rack 1022 engaged with each other, where first rack 1022 and hub 103 are detachably coupled in a direction perpendicular to the axial direction. When the first rack 1022 and the hub 103 are coupled (as shown in fig. 15 a), the first support 301 is located outside the hub 103 (i.e., below the hub 103 as shown in the drawing), the second support 302 is located outside the first rack 1022 (i.e., above the first rack 1022 as shown in the drawing), and the straight line M of the axial direction in which the first support 301 is located and the straight line N of the axial direction in which the second support 302 is located are oppositely disposed in the direction perpendicular to the axial direction to support the first rack 1022 and the hub 103 in the direction perpendicular to the axial direction, so that the first rack 1022 and the hub 103 coupled to each other can move axially between the first support 301 and the second support 302. When the first supporting member 301 moves proximally, the first supporting 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 separated, and after the first rack 1022 and the needle holder 103 are separated, the first supporting member 301 still can drive the needle holder 103 to move proximally continuously.

In other implementations, the actuating assembly 304 may not be engaged by a rack and pinion, the actuating assembly 304 may be a connection structure that may be rod-shaped, block-shaped, or the like, by pulling or pushing on the connection structure to perform an axial actuating function to control the extension and retraction of the needle 3.

In this embodiment, first, by providing the first support 301 and the second support 302, when the actuating assembly 304 and the needle holder 103 are connected, the first support 301 is located outside the needle holder 103, and the second support 302 is located outside the actuating assembly 304, and the straight line M of the axial direction in which the first support 301 is located and the straight line N of the axial direction in which the second support 302 is located are disposed opposite each other in the direction perpendicular to the axial direction, so as to support the actuating assembly 304 and the needle holder 103 in the direction perpendicular to the axial direction, that is, the first support 301 is used to support the needle holder 103, and the second support 302 is used to support the actuating assembly 304, and the first support 301, the needle holder 103, the actuating assembly 304 and the second support 302 are mutually supported on the same plane perpendicular to the axial direction, so that the four are kept from being separated in the direction perpendicular to the axial direction, but the actuating assembly 304 and the needle holder 103 connected to each other are axially movable between the first support 301 and the second support 302, so as not to affect the axial movement of the actuating assembly to control the extension and retraction of the suture needle 3.

Second, first support 301 is movably connected to hub 103, actuating assembly 304 and hub 103 are detachably connected in a direction perpendicular to the axial direction, when first support 301 moves proximally, first support 301 drives hub 103 to move proximally, and at this time, four of first support 301, hub 103, actuating assembly 304 and second support 302 still support each other on the same plane perpendicular to the axial direction, even if axial displacement occurs between these four, four remain unchanged in the direction perpendicular to the axial direction, and hub 103 can drive actuating assembly 304 to move proximally, because actuating assembly 304 controls extension and retraction of suture needle 3 through hub 103, actuating assembly 304 and hub 103 can drive actuating assembly 304 to move proximally before disengaging, thereby reducing interference of actuating assembly 304 on other components of suturing device 100 and improving operability.

Again, by providing the needle holder 103 connected to the suture needle 3, the actuating assembly 304 and the needle holder 103 can be separated from each other, so that not only the suture needle 3 having the suture thread 5 carried out (i.e., the suture needle 3 having the suture thread 5 completed in the body) can be withdrawn from the body, but also the suture needle 3 can be withdrawn from the body, a portion of the suture thread 5 connected to the suture needle 3 can be withdrawn from the body, the operator can conveniently send the knotter into the body along with the portion of the suture thread 5 withdrawn from the body, or the portion of the suture thread 5 withdrawn from the body can be directly pushed into the body after being knotted, and suture fixation can be completed.

The above-mentioned "can first drive the actuating component 304 to move proximally, so as to reduce the interference of the actuating component 304 on other components of the suturing device 100", which is applied to the specific embodiment, includes, but is not limited to, referring to fig. 12b, when the first control member 9 is in the locked state, the first rack 1022 of the second control component 102 penetrates the through hole 93 to perform the axial movement until the second control component 102 controls the suturing needle 3 to complete the suturing action, at this time, the first rack 1022 needs to be withdrawn from the through hole 93, that is, the first rack 1022 needs to be driven to move proximally, and the first control member 9 can only restore the initial state, so as to restore the suturing arm 4 to the delivery state, thereby being capable of conveniently withdrawing from the body. Therefore, the actuation assembly 304 may be moved proximally during the needle withdrawal process, thereby reducing interference of the actuation assembly 304 with other components of the suturing device 100.

In one embodiment, referring to fig. 16a, 16b and 16c, suturing device 100 further comprises a sleeve-like structure 401, sleeve-like structure 401 comprising first support 301, sleeve-like structure 401 movably coupled to hub 103, the proximal end of hub 103 disposed within sleeve-like structure 401, and the distal end of hub 103 may extend out of or into sleeve-like structure 401. The first supporting member 301 may be a side wall of the sleeve-like structure 401, or may be an element disposed on a side wall of the sleeve-like structure 401.

In an embodiment, one of the sleeve-like structure 401 and the needle holder 103 is provided with a through hole structure 1030, the other one of the sleeve-like structure 401 and the needle holder 103 is provided with a fixing structure 1033, and the fixing structure 1033 is limited to move in the through hole structure 1030, so that the sleeve-like structure 401 is movably connected with the needle holder 103, that is, the first supporting member 301 is movably connected with the needle holder 103. In an embodiment, the sleeve-shaped structure 401 is provided with an elongated through hole structure 1030, and the needle holder 103 is provided with a fixing structure 1033, where the fixing structure 1033 is a hook-shaped structure 10331, and the hook-shaped structure 10331 can abut against an inner wall 10301 of the through hole structure 1030, so that the hook-shaped structure 10331 is limited in the elongated through hole structure 1030 to perform axial movement. In another embodiment, referring to fig. 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, and 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 limited in the elongated through hole structure 1030 to perform axial movement. If multiple hubs 103 are provided, multiple securing structures 1033 may be provided that are each constrained within a different through-hole structure 1030, allowing for individual movement of multiple hubs 103.

In other embodiments, the first support 301 may not be disposed on the sleeve-like structure 401, and the first support 301 may be a planar structure, such as a flat plate or bar or block of various shapes. A connector is provided on the planar structure so as to be movably connected with the needle holder 103.

Referring to fig. 3, the handle includes a handle housing 10 and a sleeve-like structure housing 13 which are detachably connected. Referring to fig. 16 and 17a, the sleeve-like structure housing 13 is connected to the sleeve-like structure 401, and the sleeve-like structure housing 13 is disposed outside the sleeve-like structure 401. The sleeve-shaped structure shell 13 is provided with the connecting piece 131, the connecting piece 131 is inserted into the handle shell 10, the handle shell 10 is fixedly connected with the sleeve-shaped structure shell 13, the position of the sleeve-shaped structure shell 13, where the connecting piece 131 is arranged, is provided with the cutting seam 132, and the cutting seam 132 enables the position of the sleeve-shaped structure shell 13, where the connecting piece 131 is arranged, to be relatively movable relative to other positions in the sleeve-shaped structure shell 13. When the handle housing 10 and the sleeve-shaped structure housing 13 need to be fixed together, the position, in which the connecting piece 131 is arranged, of the sleeve-shaped structure housing 13 is pressed inwards in the axial direction, so that the connecting piece 131 is easy to insert into the handle housing 10, after the connecting piece 131 is inserted into the handle housing 10, the connecting piece 131 can restore to the original form outwards in the axial direction, and therefore the connecting piece can be clamped with the handle housing 10 in the axial direction, and the fixation between the handle housing 10 and the sleeve-shaped structure housing 13 is realized. When the sleeve-like structure housing 13 is required to be detached from the handle housing 10, the position of the sleeve-like structure housing 13, where the connecting piece 131 is arranged, is pressed inwards perpendicular to the axial direction, so that the connecting piece 131 is easily detached from the handle housing 10, and then the sleeve-like structure housing 13 is pulled out, thereby realizing detachment.

Referring to fig. 15a, 15b and 15c, in one embodiment, a second support 302 is provided on the inner wall of the handle housing 10. Wherein, the actuating assembly 304 is provided with a first groove 3041, the second supporting member 302 can be accommodated in the first groove 3041, when the first supporting member 301 moves proximally, the first supporting 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 second supporting member 302 is accommodated in the first groove 3041, so that the actuating assembly 304 and the needle holder 103 are separated. Specifically, as shown in fig. 15a, at this time, the sleeve-like structure housing 13 and the handle housing 10 have not been released, the second support 302 is not received in the first groove 3041, the first support 301, the needle mount 103, the actuating assembly 304 and the second support 302 are mutually supported on the same plane perpendicular to the axial direction, and the interconnected actuating assembly 304 and needle mount 103 are axially movable between the first support 301 and the second support 302. At this point, as shown in fig. 15b, the sleeve-like structure housing 13 is pulled proximally, the sleeve-like structure housing 13 is disengaged from the handle housing 10, but the second support member 302 is not received in the first recess 3041, and the first support member 301, the needle hub 103, the actuating assembly 304 and the second support member 302 remain mutually supported on the same plane perpendicular to the axial direction, at which point the actuating assembly 304 has been completely removed from the sleeve-like structure 401, and the needle hub 103 remains stationary relative to the housing 13. As shown in fig. 15c, as sleeve-like structure housing 13 continues to be pulled proximally, sleeve-like structure 401 drives hub 103 to move proximally, hub 103 drives actuating assembly 304 to move proximally until second support 302 is received in first groove 3041, the balance of forces on the same plane perpendicular to the axial direction of first support 301, hub 103, actuating assembly 304 and second support 302 is gradually broken, and in particular, the force provided by second support 302 on the portion of actuating assembly 304 connected to hub 103 is gradually reduced, and as the magnitude of force of hub 103 to actuating assembly 304 perpendicular to the axial direction and toward actuating assembly 304 is not significantly changed, actuating assembly 304 is tilted in the perpendicular axial direction (i.e. d direction) at the point where both hub 103 and actuating assembly 304 are in contact, with second support 302 as a fulcrum, actuating assembly 304 has been completely removed from sleeve-like structure 401, thereby enabling very smooth completion of the disengagement between actuating assembly 304 and hub 103.

Further, one of the actuating assembly 304 and the needle seat 103 is provided with the protruding portion 22, the other one of the actuating assembly 304 and the needle seat 103 is provided with the recessed portion 33, and the protruding portion 22 and the recessed portion 33 are matched with each other, so that the actuating assembly 304 and the needle seat 103 are detachably connected in the direction perpendicular to the axial direction, and effective connection can be realized when the other one of the actuating assembly 304 and the needle seat 103 moves. In other embodiments, protrusions 22 and depressions 33 may not be provided, the connection between actuation assembly 304 and hub 103 may be ensured solely by the friction between actuation assembly 304 and hub 103, and it will be appreciated that roughened surfaces may be provided on the surfaces of actuation assembly 304 and/or hub 103 that contact.

In another embodiment, sleeve-like structure 401 further includes second support 302, i.e., second support 302 is also disposed on sleeve-like structure 401, where both hub 103 and actuation assembly 304 contact each other at a location that is desired to be within sleeve-like structure 401, and after removal from sleeve-like structure 401, hub 103 and actuation assembly 304 can be disengaged. Specifically, pulling sleeve-like structure 401 proximally drives hub 103 to move proximally, so that actuating assembly 304 can also move proximally for a certain period until actuating assembly 304 cannot continue to move proximally, at which time, by setting detent 3040 against actuating assembly 304, for example, detent 3040 in handle housing 10 axially abuts against boss 10220 of first rack 1022, actuating assembly 304 cannot be moved proximally too much, actuating assembly 304 is disengaged from sleeve-like structure 401, and thus hub 103 and actuating assembly 304 are disengaged. In this embodiment, the above-mentioned protruding portion 22 and the recess portion 33 may also be provided, at this time, the protruding portion 22 or the recess portion 33 may be an elastic structure, when the sleeve-shaped structure housing 13 is pulled proximally, the sleeve-shaped structure 401 drives the needle holder 103 to move proximally, the needle holder 103 drives the actuating assembly 304 to move proximally, and the sleeve-shaped structure housing 13 is pulled proximally until the connection position between the needle holder 103 and the actuating assembly 304 is separated from the sleeve-shaped structure 401, and because the protruding portion 22 and the recess portion 33 are provided, at this time, the needle holder 103 and the actuating assembly 304 are still connected, and because the protruding portion 22 or the recess portion 33 is an elastic structure, the sleeve-shaped structure housing 13 is pulled proximally further, and the protruding portion 22 and/or the recess portion 33 may be separated from the recess portion 33 relatively easily in axial pulling, so as to realize separation between the needle holder 103 and the actuating assembly 304. In other embodiments, protrusions 22 and depressions 33 may not be provided, the connection between actuation assembly 304 and hub 103 may be ensured solely by the friction between actuation assembly 304 and hub 103, and it will be appreciated that roughened surfaces may be provided on the surfaces of actuation assembly 304 and/or hub 103 that contact.

In one embodiment, referring to fig. 18a, 18b and 18c, the suturing device 100 further comprises a thread cutter 200, the thread cutter 200 being disposed on the suturing device 100, the thread cutter 200 comprising a grip 201 and a cutting portion 202 connected to each other, the suture 5 passing through the cutting portion 202, pulling the grip 201 to bring the suture 5 into abutment with the cutting portion 202, cutting the suture 5. In the present embodiment, the wire cutter 200 is provided in the handle 1, the grip 201 is provided inside the handle housing 10, and the cutout 202 is provided outside the handle housing 10. When the suture needle 3 drives the suture 5 to be drawn out, the suture 5 is prevented from being too long, and the suture 5 left outside the body can be cut short. The shearing portion 202 is provided with a strip-shaped hole 2020, and a blade 2023 is provided on an inner wall of the strip-shaped hole 2020.

In one embodiment, and in conjunction with fig. 3, 19a, 19b and 19c, the suturing device 100 further comprises a wire coil 300, the suture 5 is wound on the wire coil 300, the wire coil 300 is rotated to release the suture 5, the first control member 9 controls the fixation or release of the wire coil 300, the wire coil 300 has a fixed state and a released state, and the first control member 9 has an initial state and a locked state.

Referring to fig. 19a, the wire coil 300 is in a fixed state when the first control member 9 is in an initial state, and referring to fig. 19b, the wire coil 300 is in a relaxed state when the first control member 9 is in a locked state. Wherein the suture 5 is wound on the wire coil 300, a portion of the suture 5 is wound on the wire coil 300, and another portion of the suture 5 extends along the sheath 2 toward the suture arm 4, so that at least one end of the suture 5 is connected to the suture arm 4. In one embodiment, after the suture 5 is folded in half, both ends of the suture are connected to the suture arms 4, and the folded position of the suture 5 is located on the wire coil 300. In another embodiment, one end of suture 5 is connected to suture arm 4 and the other end of suture 5 is positioned on wire coil 300.

Wherein, in one embodiment, referring again to fig. 19c, the wire coil 300 comprises an upper cam ring 300a, a lower cam ring 300b, a winding portion 300c and a separator 300d, wherein the winding portion 300c is positioned between the upper cam ring 300a and the lower cam ring 300b, wherein the upper cam ring 300a and the lower cam ring 300b are used to limit the winding position of the suture 5, wherein the lower cam ring 300b can also be used to cooperate with the first control member 9 to achieve the fixation or release of the wire coil 300 described in the above embodiment, wherein the lower cam ring 300b is further provided with a damping structure, such as arranging the outer surface of the lower cam ring 300b as a polyhedron surface 300b1 to increase the tightness of the cooperation of the lower cam ring 300b with the first control member 9. In addition, a spacer 300d may be used to separate the wire wrap portion 300c from the lower cam ring 300b to avoid affecting the release of the suture 5 on the wire wrap portion 300c when the lower cam ring 300b is mated with the first control member 9. In another embodiment, referring to fig. 21, the separator 300d may not be provided.

Referring to fig. 19c, the wire coil 300 is further provided with a hooking member 3001, wherein the hooking member 3001 may be disposed at any one or more positions on the upper bead 300a, the lower bead 300b, the winding portion 300c, and the separator 300 d. When the suture 5 is folded in half, both ends of the suture 5 are connected with the suture arm 4, the folding position 501 of the suture 5 is located on the wire coil 300, at this time, in order to facilitate winding of the folded suture 5 onto the wire coil 300, the folding position 501 of the suture 5 is firstly hooked on the hooking member 3001, then the folded suture 5 is wound on the wire coil 300 with the folding position 501 of the suture 5 hooked on the hooking member 3001 as a starting point, winding of the suture 5 is completed, and then another part of the suture 5 is extended to the suture arm 4 along the sheath 20 and connected with the suture arm 4 through the threading hole 502 (see fig. 20) on the handle housing 10. In this embodiment, the hooking member 3001 is a small bump 3001a, specifically, a small bump 3001a is cut on the upper collar 300a, and the small bump 3001a is spaced from other portions of the upper collar 300a, and in other embodiments, the hooking member 3001 may be a hook structure, a rod structure, or the like on the wire coil 300 or otherwise mounted on the wire coil 300, so long as the folded position 501 of the suture thread 5 can be hooked.

In this embodiment, the first control member 9 may also be used to control the transition between the delivery state and the deployment state of the stapling arm 4, for a specific control procedure, see the previous embodiments. When the first control member 9 is in the initial state, the suture arm 4 is in the delivery state, the wire coil 300 is in the fixed state, and when the first control member 9 is in the locking state, the suture arm 4 is in the unfolded state, and the wire coil 300 is in the relaxed state. In other embodiments, the first control member 9 may be used only to control the fixation and release of the wire coil 300, the suture arm 4 may be controlled by another element, or the suture arm 4 is covered with a protecting structure, and the suture arm 4 is always in a unfolded state, so that the state of the suture arm 4 is not required to be controlled, and the protecting structure is removed to reach the target position.

In this embodiment, by providing the first control member 9 having the initial state and the locked state, the first control member 9 controls the transition between the fixed state and the released state of the wire coil 300 to avoid the wire coil 300 from being in the released state all the time, releases the excessive sutures 5, causes the excessive sutures 5 to be easily piled up to be knotted, and easily interferes with other operations of the suturing device 100. The wire coil 300 is loosened when needed, and the operability and controllability are enhanced.

In an embodiment, referring to fig. 19a and 19b, the first control member 9 includes a main body 92, the main body 92 includes a first main body 921 and a second main body 922, the first main body 921 and the second main body 922 are disposed opposite to each other, the wire coil 300 is disposed between the first main body 921 and the second main body 922, the first main body 921 has a first main body inner wall 9210 on a side close to the wire coil 300, the second main body 922 has a second main body inner wall 9220 on a side close to the wire coil 300, and a position where the wire coil 300 is disposed between the first main body 921 and the second main body 922 is the first position P. In the first position P, the distance between the first body member inner wall 9210 and the second body member inner wall 9220 when the first control member 9 is in the initial state is smaller than the distance between the first body member inner wall 9210 and the second body member inner wall 9220 when the first control member 9 is in the locked state, so that the fixation and release of the wire coil 300 in the radial direction of the wire coil 300 are achieved. The wire coil 300 can be clamped when the distance between the first body member inner wall 9210 and the second body member inner wall 9220 is small, and the wire coil 300 can be released when the distance between the first body member inner wall 9210 and the second body member inner wall 9220 is large, and the wire coil 300 can be kept in a released state.

In this embodiment, by providing the recess 9211 at a part of the first body member inner wall 9210, the distance between the first body member inner wall 9210 and the second body member inner wall 9220 is made large. When the first control member 9 is in the initial state, the part of the first body member inner wall 9210 where the concave portion 9211 is not provided abuts against the wire coil 300 in the first position P, and when the first control member 9 is in the locked state, the part of the first body member inner wall 9210 where the concave portion 9211 is provided abuts against the wire coil 300 in the first position P. In other embodiments, the second body member inner wall 9220 may be provided with recesses at the same time, or only the second body member inner wall 9220 may be provided with recesses. In other embodiments, the overall thickness of the first body member 921/the second body member 922 is uniform without providing a recess, so long as the distance between the first body member 921 and the second body member 922 decreases when the first control member 9 is in the initial state at the first position P, and the distance between the first body member 921 and the second body member 922 increases when the first control member 9 is in the locked state.

In the present embodiment, the first operating portion 91 is operated to rotate the first and second body members 921 and 922 connected to each other. In other embodiments, by providing different operating portions, one of the first body member 921 and the second body member 922 may be rotated to secure or release the wire coil 300 by changing the distance between the side walls of the two body members. In other embodiments, the first body member 921 and/or the second body member 922 may be directly rotated without providing an operation portion.

Referring to fig. 3, 19 and 20, in one embodiment, the wire coil 300 may be disposed on the exterior of the handle housing 10, and the body 92 may be disposed on the interior of the handle housing 10, with an opening 1011 disposed in the handle housing 10 at the first position P, and the first body member inner wall 9210 may be disposed through the opening 1011 and abut the wire coil 300. It will be appreciated that in the first position P, the handle housing 10 may be further provided with a further aperture 1011 through which the second body member inner wall 9220 can be passed against the wire coil 300. Referring to fig. 21, 22, and 23, in one embodiment, the suturing device 100 further includes a stationary cover 330, the stationary cover 330 covering the exterior of the wire tray 300. Referring to fig. 23a and 23b, when the first control member 9 is in the initial state, the first control member 9 is pushed against one end of the wire coil 300, the other end of the wire coil 300 is fixed with the fixed cover 330, and referring to fig. 23c and 23d, when the first control member 9 is in the locked state, the other end of the wire coil 300 is separated from the fixed cover 300. So arranged, the fixation and release of the wire coil 300 can be achieved in the height direction of the wire coil 300. In this embodiment, the fixed cover 330 is fixedly connected to the handle housing 10, so that the fixed cover 330 is kept fixed.

In this embodiment, the first control member 9 includes an ejector member 910, an ejector portion 910a is provided at one end of the ejector member 910, and the first control member 9 is rotatable. When the first control member 9 is in the initial state, the ejection portion 910a is adjacent to one end of the wire coil 300 and abuts against the wire coil 300, thereby fixing the wire coil 300, and when the first control member 9 is rotated to the locked state, the ejection portion 910a is distant from one end of the wire coil 300, thereby releasing the wire coil 300.

Further, the suturing device 100 further includes an elastic member 311, and both ends of the elastic member 311 are connected to the fixed cover 330 and the wire coil 300, respectively. When the first control member 9 is in the initial state, the ejection part 910a is close to one end of the wire coil 300 and pushes against the wire coil 300, thereby fixing the wire coil 300, at this time, the elastic member 311 is compressed, and elastic potential energy is stored, and when the first control member 9 is rotated to the locked state, one end of the ejection part 910a, which is far away from the wire coil 300, releases elastic potential energy, which acts on the wire coil 300, thereby accelerating the wire coil 300 to be separated from the fixed cover 330, and accelerating the release of the wire coil 300.

Further, the other end of the wire coil 300 is provided with a first fixing portion 111, the fixing 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, the other one of the first fixing portion 111 and the second fixing portion 112 is a bump, and the bump is connected with the groove, so that the fixing performance of the wire coil 300 and the fixing cover 330 is improved.

In one embodiment, the fixation and release of the wire coil 300 can be achieved in the radial direction of the wire coil 300 and the height direction of the wire coil 300 at the same time in the above-described manner. Specifically, this may be accomplished by including, but not limited to, the placement of the ejection member 910 on the body portion 92. In other embodiments, the securing and releasing of the wire coil 300 may be accomplished in either the radial direction of the wire coil 300 or the height direction of the wire coil 300.

Referring again to fig. 21, the wire coil 300 is at least partially disposed outside the handle housing 10, a first post 312 is disposed on the handle housing 10, the wire coil 300 is inserted into the first post 312, and the wire coil 300 is rotated about the first post 312 to release the suture 5.

Referring to fig. 21 and 24, an opening 313 is formed at one end of the wire coil 300 near the handle housing 10, a first damping structure 314 is formed on the inner wall of the wire coil 300, that is, a first damping structure 314 is formed on the inner wall around the opening 313, a second damping structure 315 matched with the first damping structure 314 is formed on the handle housing 10, and the first damping structure 314 moves relative to the second damping structure 315 along with the rotation of the wire coil 300, so that the rotation speed of the wire coil 300 is slowed down. In other embodiments, the outer wall of the wire coil 300 near one end of the handle housing 10 is provided with a first damping structure 314, and the handle housing 10 is provided with a second damping structure 315 that mates with the first damping structure 314.

In operation, when the distal end of the suture needle 3 is connected to the suture arm 4, at least one end of the suture thread 5 on the suture arm 4 is pulled out, and then the suture needle 3 is displaced, the suture thread 5 is driven to displace, and the suture thread 5 drives the wire coil 300 to rotate, so as to release the suture thread 5 wound on the wire coil 300. Because of the inertia of the rotation of the wire coil 300, the wire coil 300 is easily rotated too fast, so that too many sutures 5 wound on the wire coil are released, too many released sutures are easily piled up to form a knot, and other operations of the suturing device 100 are easily disturbed. It is therefore necessary to slow the rotational speed of the wire coil 300 so that a reasonable amount of suture 5 can be released.

Referring to fig. 25a, 26 and 27, in an embodiment, the handle 1 further includes a receiving structure 122, the receiving structure 122 is fixedly connected with the sheath tube 2, the receiving structure 122 includes a first portion 1221, the first portion 1221 abuts against the handle housing 10, the first portion 1221 is provided with a first mating structure 1222, 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 bump structure 1221a, 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 circumferentially arranged, the receiving structure 122 is rotated, and the receiving structure 122 moves circumferentially relative to the handle housing 10, so that one bump structure 1221a moves sequentially in the plurality of concave structures 1221 b.

Referring to fig. 27, in this embodiment, by setting the receiving structure 122, the receiving structure 122 is connected with the sheath tube 2, rotating the receiving structure 122, the receiving structure 122 moves circumferentially relative to the handle housing 10, so that after the sheath tube is conveyed into the body, the circumferential relative position of the receiving structure 122 and the handle housing 10 can be adjusted, so as to rotate the sheath tube 2, adjust the circumferential position of the sheath tube 2, adapt to the internal environment more flexibly, and simultaneously keep other parts of the handle 1 motionless, and facilitate the operation of other parts on the handle 1. In addition, by providing the first fitting structure 1222 and the second fitting structure 1223 on the first portion 1221 of the receiving structure 122 and the handle housing 10, respectively, one of the first fitting structure 1222 and the second fitting structure 1223 is at least one bump structure 1221a, and the other of the first fitting structure 1222 and the second fitting structure 1223 is a plurality of concave structures 1221b, and the plurality of concave structures 1221b are circumferentially disposed, and the receiving structure 122 is rotated, and the receiving structure 122 circumferentially moves relative to the handle housing 10, so that the bump structure 1221a sequentially moves in the plurality of concave structures 1221b, thereby quantitatively controlling the circumferential rotation angle of the receiving structure 122 during the rotation process, so as to more precisely control the circumferential rotation angle of the sheath tube 2, improve the accuracy of the surgical operation process, and improve the surgical success rate. In this embodiment, the distal end of the sheath 2 has a curved portion, or has no curved portion. In fig. 27, the first mating structure 1222 is a recess structure 1221b, the second mating structure 1223 is a bump structure 1221a, and referring to fig. 28, in another embodiment, the first mating structure 1222 is a bump structure 1221a, it can be appreciated that the second mating structure 1223 is a recess structure 1221b.

In an embodiment, the recess structure 1221b includes a first recess 1221b1 and a second recess 1221b2 connected to each other, and the bump structure 1221a moves from the first recess 1221b1 to the second recess 1221b2 or from the second recess 1221b2 to the first recess 1221b1, bringing the sheath 2 to rotate clockwise or counterclockwise circumferentially relative to the handle housing 10 by a first angle e. In this embodiment, the rotating angle of the sheath tube 2 can be adjusted more precisely by rotating clockwise or counterclockwise, so that the sheath tube can be adjusted or corrected to a proper angle reversibly due to overlarge rotation in one direction in the operation process.

In an embodiment, the receiving structure 122 further includes a second portion 1224, where the second portion 1224 is fixedly connected to the sheath 2, and the first portion 1221 is disposed on an outer surface of the second portion 1224, so as to facilitate connection of the receiving structure 122 to the sheath 2, and not affect the cooperation between the receiving structure 122 and the handle housing 10. Specifically, the second portion 1224 is at least partially disposed through the handle housing 10, the proximal end of the first portion 1221 abuts against the distal end of the handle housing 10, the proximal end of the first portion 1221 is provided with a first mating structure 1222, and the distal end of the handle housing 10 is provided with a second mating structure 1223. In other embodiments, the receiving structure 122 may not include the second portion 1224, but may include only the first portion 1221, wherein one end of the first portion 1221 may be connected to the sheath 2 and the other end of the first portion 1221 may mate with the handle housing 10.

Referring to fig. 25a and 25b, in one embodiment, the handle 1 further comprises a knob 123, wherein the knob 123 is sleeved and fixed on the receiving structure 122, so that the receiving structure 122 can be conveniently rotated by the knob 123. In other embodiments, knob 123 may not be included and receiving structure 122 may be rotated directly.

Knob 123 is provided with knob stopper 1231, and handle shell 10 is provided with shell stopper 1232, and knob 123 cover is established on accepting structure 122, rotates knob 123 towards first direction Q, and knob stopper 1231 and shell stopper 1232 circumference backstop each other, prevent knob 123 to continue to rotate towards first direction Q. Wherein the first direction Q may be a clockwise or counter-clockwise direction.

The knob stopper 1231 includes a first knob stopper 1231a and a second knob stopper 1231b, the housing stopper 1232 moves between the first knob stopper 1231a and the second knob stopper 1231b, or the housing stopper 1232 includes a first housing stopper 1232a and a second housing stopper 1232b, and the knob stopper 1231 moves between the first housing stopper 1232a and the second housing stopper 1232 b. So configured, the circumferential rotation between the knob stopper 1231 and the housing stopper 1232 can be controlled within a certain range in the entire circumference such that the knob stopper 1231 cannot rotate one full turn with respect to the housing stopper 1232, that is, the knob 123 rotates within a certain range in the entire circumference with respect to the handle housing 10, thereby controlling the angle of the circumferential rotation of the sheath 2.

In another embodiment, the knob 123 has an initial state, the knob 123 is provided with a first positioning member 1233, the receiving structure 122 is provided with a second positioning member 1234, and when the knob 123 is connected to the receiving structure 122, the first positioning member 1233 and the second positioning member 1234 are connected to each other and fixed, so that the knob 123 is in the initial state when being matched with the handle housing 10. In the installation, can be with accepting structure 122 and handle shell 10 connection, rethread first setting element 1233 and second setting element 1234 cooperate and be connected knob 123 to accepting structure 122 on, consequently can be through the initial hookup location of control knob 123 with accepting structure 122 to can control knob stopper and handle shell 10 initial hookup location, thereby can control the circumference distance between knob stopper 1231 and the shell stopper 1232, thereby control knob 123 rotatory angle scope, further can accurate control sheath 2 circumference pivoted angle scope. In other embodiments, the first knob stopper 1231a, the second knob stopper 1231b, the first positioning member 1233, and the second positioning member 1234 may be simultaneously provided, or the first housing stopper 1232a, the second housing stopper 1232b, the first positioning member 1233, and the second positioning member 1234 may be simultaneously provided, thereby more precisely controlling the angular range of the circumferential rotation of the sheath 2.

In another embodiment, it is understood that a stop may also be provided on the receiving structure 122, in particular, it is understood that the receiving structure 122 may be provided with a receiving structure stop, the handle housing 10 is provided with a housing stop 1232, rotating the knob 123 in the first direction, the receiving structure stop and the housing stop 1232 stopping the receiving structure from continuing to rotate in the first direction.

Referring to fig. 27, in order to better secure the receiving structure 122 and the handle housing 10 together, securing elements 1225, 1226 are provided on the receiving structure 122 and the handle housing 10, respectively. 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 bump structure, and the groove structure and the bump structure are mutually matched and connected. Referring to fig. 28, in one embodiment, the securing element 1225 of the receiving structure 122 is a bump structure, and the securing element 1226 of the handle housing 10 is a groove structure, which are cooperatively connected with each other.

In this embodiment, in embodiments having a receiving structure 122, the receiving structure 122 may be applied to the suturing device 100, and it will be appreciated that any delivery device may be used, and that the delivery device 1000 includes a handle 1 and a sheath 2 coupled to one another, as seen in FIG. 1.

Taking the example of suturing the patent foramen ovale with suturing device 100 in this embodiment, in which the number of suturing needles 3 is two, first suturing needle 31 and second suturing needle 32, respectively, referring to fig. 29a, two ends 5a and 5b of suture 5 are located on either side of suturing arm 4, respectively, and a middle portion 5c of suture 5 extends proximally along sheath 2 until it can be wound on wire coil 300. The general procedure may be to deliver the suturing device 100 to the target site along a guidewire, to pass the distal end of the suturing device 100 through the foramen ovale, to deploy the suturing arm 4, to abut against the native septum 600 and the secondary septum 700, respectively, on both sides of the suturing arm 4, to then, with reference to fig. 29b, to extend the first suturing needle 31 through the native septum 600 to connect one side of the suturing arm 4, to withdraw one end 5a of the suture 5 from the suturing arm 4, to extend the second suturing needle 32 through the secondary septum 700 to connect the other side of the suturing arm 4, to withdraw the other end 5b of the suture 5 from the suturing arm 4, to then withdraw the first and second suturing needles 31, 32, respectively, proximally into the sheath 2 until the two ends 5a, 5b of the suture 5 are withdrawn, respectively, and at the same time, the intermediate portion 5c of the suture 5 is slowly released from the wire coil 300, to then slowly moved distally until the native septum and secondary septum position is reached (see fig. 29 c), to finally, to withdraw the other end 5b of the suture 5 from the suturing arm 4, to cut the portion of the suture 5, and to complete the patent foramen ovale. Wherein for simplicity of illustration, the first needle 31, the second needle 32, the suture arm 4, the sheath 2 and the coil 300 are not shown in fig. 29a, 29b and 29c, and the related structures are referred to in the previous embodiments.

The above-mentioned embodiments are only preferred embodiments of the present invention, but the protection scope of the present invention is not limited thereto, and any changes or substitutions easily conceivable by those skilled in the art within the technical scope of the present invention should be covered in the protection scope of the present invention. Therefore, the protection scope of the invention is subject to the protection scope of the claims.

Claims

1. A suturing device comprising a suturing needle, a suturing arm and a suture thread, at least one end of the suture thread being located on the suturing arm, a distal end of the suturing needle being connectable to the suturing arm for withdrawing the at least one end of the suture thread from the suturing arm, characterized in that the suturing device further comprises an actuation assembly, a needle hub, a first support and a second support, the first support being movably connected to the needle hub,

2. The suturing device of claim 1, further comprising a sheath structure including the first support, the sheath structure being movably coupled to the hub, the proximal end of the hub being disposed within the sheath structure, the distal end of the hub being extendable out of or into the sheath structure.

3. The suturing device of claim 2 wherein one of the hub and hub is provided with a through-hole structure and the other of the hub and hub is provided with a securing structure that is constrained to move within the through-hole structure.

4. The suturing device of claim 2, further comprising a handle comprising a detachably connected handle housing and a sleeve housing, the actuation device moving within the handle housing, the sleeve housing being connected to the sleeve, the sleeve housing being disposed outside the sleeve.

5. The suturing device of claim 4 wherein the sheath housing is provided with a connector which is inserted into the handle housing to fixedly connect the handle housing to the sheath housing, the sheath housing being provided with a slit at a location thereof at which the connector is provided, the slit enabling relative movement of the sheath housing at the location thereof at which the connector is provided with respect to other locations of the sheath housing.

6. The suturing device of claim 2, further comprising a handle housing, wherein the second support is disposed on an inner wall of the handle housing.

7. The suturing device of claim 6, wherein the actuation assembly includes a first recess in which the second support is receivable, the first support moving the hub proximally when the first support moves proximally, the hub moving the actuation assembly proximally until the second support is received in the first recess to disengage the actuation assembly from the hub.

8. The suturing device of claim 2, wherein the sheath structure further comprises the second support.

9. The suturing device of claim 1, wherein one of the actuation assembly and the hub is provided with a boss and the other of the actuation assembly and the hub is provided with a recess, the boss and the recess cooperating to detachably connect the actuation assembly and the hub in a direction perpendicular to the axial direction.

10. The suturing device of claim 1, further comprising a thread cutter disposed on the suturing device, the thread cutter including a gripping portion and a cutting portion interconnected, the suture passing through the cutting portion, pulling the gripping portion to engage the suture with the cutting portion to cut the suture.