Tissue closure device and closure method

Abstract

The invention discloses a tissue closing device and a closing method, the tissue closing device is provided with a far end and a near end which are opposite, and the tissue closing device comprises a handle provided with a driving mechanism; the delivery assembly has a shape suitable for intervention, and the near end of the delivery assembly is connected with the handle; the two arms are installed at the far end of the delivery assembly and controlled by the corresponding driving mechanisms through the delivery assembly, each arm is provided with a needle holding mechanism, the two arms are configured to be capable of moving relatively, and in the relative movement process, the two arms interact through the respective needle holding mechanisms to be used for threading suture needles to tissue. The tissue closing device and the closing method are convenient to operate, are more suitable for large-diameter tissue suturing, can shorten the hemostasis time after an interventional therapy operation, simplify the operation process and reduce the infection risk.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a tissue closure device and a closure method. Background Art

[0002] Traditional vascular hemostasis methods usually involve manual compression, assisted by mechanical forceps and hemostatic pads. The biggest disadvantage is the lack of direct observation of the groin area. It needs to be carefully placed on the surface of the arteriotomy hole, and manually pressed for tens of minutes with a hemostatic pad with a coagulant to achieve the purpose of hemostasis. With the innovation of technology, various specially designed devices have begun to be used to achieve the closure of vascular wounds left by transcatheter surgery. An ideal vascular closure device should provide effective and rapid hemostasis, be simple to use, produce fewer complications, and have a good hemostatic effect.

[0003] The existing vascular closure devices can be roughly divided into three categories according to the hemostatic treatment method: suture, embolization, and staple clips. Embolism often uses degradable substances, and the decomposition of such substances may cause more risks, such as transportation and storage, and the formation of blood clots. Staple clip products are limited by the shape and size of the staple clips themselves, usually with a fixed caliber and a small caliber. Suture-type vascular closure devices are generally composed of sutures and suture trimmers. The suture uses pre-embedded suture technology, including two stainless steel needles and sutures, to achieve single-handle two-point suturing. Compared with incision and suture, it has the advantages of reducing the chance of complications, shortening patient immobilization and hospitalization time, etc., and can be widely used in coronary intervention, radiofrequency ablation, structural heart disease, extracorporeal circulation and other heart-related procedures.

[0004] However, the prior art still has the following defects:

[0005] 1) Maintain a uniform and steady increase in force during operation

[0006] When puncturing a pre-stitched suture, if the needle hits a hard object such as calcification, and the force applied is high and fast, it will cause the needle to bend, which will cause the sleeve to dislocate;

[0007] 2) The stitching is easy to break

[0008] The guide rail of the needle is very fragile when the stitch foot is opened. The cross-section of the stitch foot shows that the front and rear ends of the stitch foot have different shapes. The cross-section of the rear end of the stitch foot is smaller, so this part is more likely to break, causing the needle to deviate.

[0009] 3) When suturing a large diameter (larger than 8F), at least two sutures are required, and there is a chance that other occlusion devices will be needed to stop bleeding again after suturing. Summary of the invention

[0010] The present application provides a tissue closure device and a closure method, which are not only convenient to operate, but also more suitable for suturing large-caliber tissues.

[0011] The present application discloses a tissue closing device having a distal end and a proximal end opposite to each other, and the tissue closing device comprises:

[0012] A handle, configured with a driving mechanism;

[0013] a delivery assembly having a shape suitable for intervention and connected proximally to the handle;

[0014] An arm is mounted at the distal end of the delivery assembly, and a first needle holding mechanism is provided on the arm, wherein the first needle holding mechanism comprises:

[0015] A needle slot, provided in the arm, for receiving a suture needle in a detachable manner;

[0016] A movable pin is passed through the arm, and one end of the movable pin is a working end for locking or releasing the sewing needle.

[0017] Several optional methods are also provided below, but they are not intended to be additional limitations on the above-mentioned overall solution, but are merely further supplements or preferences. Under the premise that there are no technical or logical contradictions, each optional method can be combined with the above-mentioned overall solution separately, and multiple optional methods can also be combined.

[0018] Optionally, a single suture needle is also included, which is in the shape of a straight rod and has two opposite ends, and each end can be detachably inserted into a corresponding needle holding mechanism.

[0019] Optionally, the outer peripheral wall of the suture needle has a coupling groove, and the movable pin cooperates with the coupling groove.

[0020] Optionally, the inner wall of the needle groove is provided with a pin hole, and the working end of the movable pin can move in and out of the pin hole;

[0021] The arm has an extension channel in the interior thereof which is connected with the pin hole. The other end of the movable pin opposite to the working end extends toward the proximal end via the extension channel and is controlled by a driving mechanism.

[0022] Optionally, there are two arms, one of which is provided with the first needle holding mechanism, and the other is provided with a second needle holding mechanism, and the second needle holding mechanism includes:

[0023] A needle slot, provided in the arm, for receiving a suture needle in a detachable manner;

[0024] A fixed convex point is convexly arranged on the inner wall of the needle groove to squeeze the outer peripheral wall of the sewing needle;

[0025] The elastic member and the fixed protrusion act on both sides of the sewing needle in the radial direction.

[0026] Optionally, the delivery assembly includes a first delivery shaft that is slidably fitted and a second delivery shaft that is located within the first delivery shaft, and the two arms include:

[0027] a first arm fixed to the distal end of the first delivery shaft;

[0028] The second arm is hinged to the distal end of the second delivery shaft, and the distal end of the second delivery shaft extends beyond the first delivery shaft.

[0029] Optionally, the delivery assembly further comprises a third delivery shaft, the third delivery shaft is inserted into the interior of the first delivery shaft, the distal end of the third delivery shaft is connected to the second arm, and drives the second arm to swing relative to the second delivery shaft;

[0030] The proximal end of the third delivery shaft is connected to a corresponding driving mechanism.

[0031] Optionally, a swing axis of the second arm relative to the second delivery axis is perpendicular to an extension direction of the second delivery axis.

[0032] Optionally, the delivery assembly further includes a fourth delivery shaft, the distal end of the fourth delivery shaft is connected to the movable pin, and the proximal end of the fourth delivery shaft is connected to a corresponding driving mechanism.

[0033] The present application also provides a tissue closure method implemented based on the tissue closure device described in the present application, which is used to close the suture area on the tissue by means of sutures, comprising:

[0034] The suture is passed along the edge of the suture area several times in a sinking and floating manner;

[0035] Tighten the two ends of the suture and tie a knot to keep the suture area closed.

[0036] Optionally, the path along which the suture needle passes the suture into the tissue is a straight line.

[0037] The tissue closure device and closure method of the present application are not only easy to operate, but also more suitable for large-caliber tissue suturing, which can shorten the postoperative hemostasis time of interventional treatment, simplify the surgical process and reduce the risk of infection. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 A schematic diagram of the structure of a tissue closure device according to an embodiment of the present application;

[0039] Figure 2 A schematic diagram of the structure of a tissue closure device according to an embodiment of the present application;

[0040] Figure 3 A schematic diagram of the structure of a tissue closure device according to an embodiment of the present application;

[0041] Figure 4 for Figure 1 Exploded view of the tissue closure device;

[0042] Figure 5 for Figure 1 a cross-sectional view of a tissue closure device;

[0043] Figure 6 for Figure 5 A magnified view of middle;

[0044] Figure 7 is a schematic diagram of the structure of a suture needle;

[0045] Figure 8a to Figure 8f It is a schematic diagram of the structure of the two arms of the tissue closure device interlacing sutures when the tissue closure device is extended into the tissue wound;

[0046] Fig. 9 for Figure 5 Enlarged view of middle B;

[0047] Fig.10 It is a schematic diagram of the structure in which the operating handle extends out of the housing;

[0048] Fig.11 for Fig.10 The structural schematic diagram of the shell is omitted;

[0049] Fig.12 for Fig.11 A schematic diagram of the structure from another perspective;

[0050] Fig.13 This is a structural schematic diagram of the cooperation between the dial button and the connecting socket according to an embodiment of the present application;

[0051] Fig.14 for Fig.13 A schematic diagram of the structure from another perspective;

[0052] Fig.15 for Fig.13 Schematic diagram of the structure of the middle shift button and the connecting seat;

[0053] Fig.16 This is a schematic diagram of the structure of the cooperation between the dial button and the connecting socket in another embodiment of the present application;

[0054] Fig.17 for Fig.16 A structural schematic diagram showing a partial cross-section of the dial button;

[0055] Fig.18 for Fig.16 Schematic diagram of the structure of the middle shift button and the connecting seat;

[0056] Fig.19 A partial schematic diagram of a tissue closure device according to an embodiment of the present application with the housing omitted;

[0057] Fig. 20 A partial schematic diagram of a tissue closure device according to an embodiment of the present application with half of the shell omitted;

[0058] Fig.21 for Fig. 20 A schematic diagram of the structure of an operating handle with a limiter;

[0059] Fig. 22 It is a structural schematic diagram of the limit head at the end of the second slideway;

[0060] Fig.23 It is a structural schematic diagram of the limit head in the intersection area;

[0061] Fig.24 It is a structural schematic diagram of the limit head being at the upper end of the first slideway;

[0062] Figure 25a to Figure 25e It is a schematic diagram of the structure of the corresponding arms interacting with the needles when the operating handle is toggled;

[0063] Fig.26 An exploded view of a tissue closure device according to an embodiment of the present application;

[0064] Fig. 27 A partial cross-sectional view of a tissue closure device according to an embodiment of the present application;

[0065] Fig.28 A flowchart of a tissue closure method according to an embodiment of the present application;

[0066] Fig.29 Schematic diagram of the structure of suturing tissue using the sinking and floating method;

[0067] Fig.30 Schematic diagram of the structure when the suture is tightened.

[0068] The reference numerals in the figures are described as follows:

[0069] 10, distal end; 20, proximal end;

[0070] 100, handle; 110, housing; 111, window; 120, driving mechanism; 121a, operating handle; 121b, operating handle; 122, operating end; 123a, connecting rod; 123b, connecting rod; 124a, dial button; 124b, dial button; 125a, support; 125b, support; 126, avoidance; 127, baffle; 128, protrusion; 129, positioning port; 130, pivot;

[0071] 200, delivery assembly; 210, first delivery axis; 211a, sleeve; 211b, sleeve; 212a, connection seat; 212b, connection seat; 213a, mounting hole; 213b, mounting hole; 214, adjustment position; 215, positioning block; 220, second delivery axis; 230, third delivery axis; 240, fourth delivery axis; 250, interlocking structure; 251, retaining frame; 252, guide slide; 2521, first slide; 2522, second slide; 253, stopper; 255, stopper head; 2551, extension; 256, intersection;

[0072] 310, first arm; 320, second arm; 321, mounting hole; 330, needle holding mechanism; 331, needle holding mechanism; 340, needle slot; 341, clamping slot; 350, fixed convex point; 360, elastic member; 370, movable pin; 371, working end; 380, extension channel;

[0073] 400, suture needle; 401, groove; 402, thread hole; 403, suture; 404, tissue; 410, coupling groove; 420, suture area. DETAILED DESCRIPTION

[0074] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0075] It should be noted that when a component is referred to as being "connected" to another component, it may be directly connected to the other component or there may be a central component. When a component is referred to as being "disposed on" another component, it may be directly disposed on the other component or there may be a central component at the same time.

[0076] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art to which this application belongs. The terms used herein in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0077] In this application, the terms "first", "second", etc. are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number or order of the indicated technical features. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0078] In this application, the terms "comprises" and "having" and any variations thereof are intended to cover non-exclusive inclusions, for example, a system, product or device comprising a series of units is not necessarily limited to those units explicitly listed, but may include other units not explicitly listed or inherent to these products or devices.

[0079] An embodiment of the present application provides a tissue closure device, which is particularly suitable for suturing large-caliber tissues due to its structural improvement. The tissue below takes the blood vessel wall as an example, and the tissue wound is the incision or puncture made in the blood vessel wall during surgery.

[0080] refer to Figure 1 to Figure 7 , a tissue closure device having a distal end 10 and a proximal end 20 opposite to each other, the tissue closure device comprising:

[0081] The handle 100 is provided with a driving mechanism 120;

[0082] A delivery assembly 200 having a shape suitable for intervention and a proximal end 20 connected to the handle 100;

[0083] The two arms are mounted at the distal end 10 of the delivery assembly 200 and are controlled by the corresponding driving mechanism 120 via the delivery assembly 200. A needle holding mechanism is provided on each arm. The two arms are configured to move relative to each other, and during the relative movement, the suture needle 400 is interactively used to thread the suture 403 into the tissue through their respective needle holding mechanisms.

[0084] The distal end 10 in this embodiment is understood to be the end pointing to the tissue (wound) during suturing, that is, the end away from the operator, and the proximal end 20 corresponds to the end close to the operator. The handle 100 is used for holding, and the delivery assembly 200 is controlled by the driving mechanism 120 so that the corresponding needle holding mechanisms of the two arms alternately suture the tissue.

[0085] In the prior art, the mechanism of the alternating suture needles (equivalent to the two arms) is relatively fixed, and the alternation of the suture needles is completed by pushing the suture needles against the movable parts installed inside each mechanism, but the fixed arrangement cannot adapt to the tissue parts with large size changes. In this embodiment, the two movable arms can use the arms facing the suture needles to press against the tissues when the suture needles are alternating, which facilitates the accurate puncture of the suture needles and reduces the deformation of the puncture parts.

[0086] Interactive sutures can be understood as the tissue to be sutured is located between two needle holding mechanisms, one of the needle holding mechanisms 330 holding the suture needle 400 punctures the tissue under the action of the driving mechanism 120 and delivers the suture needle 400 to the other needle holding mechanism 331, and then the other needle holding mechanism 331 moves to the next position, punctures the tissue again and delivers the suture needle 400 to the original needle holding mechanism 330, and the above steps are repeated to complete the threading.

[0087] The tissue closure device of the present application can sew tissues of different sizes by reciprocating multi-point suturing according to actual needs, and the suturing process only requires a single tissue closure device, which is more convenient and quick to operate. During surgery, only a single suture needle 400 is required for reciprocating threading. The suture needle 400 can be in the shape of a straight rod and have two opposite ends, each end of which can be detachably plugged into a corresponding needle holding mechanism. As a surgical consumable, the suture needle 400 is separable from the tissue closure device of the present application and does not need to be pre-installed by a professional, and can be stored separately. Of course, it can also be pre-installed in the corresponding needle slot as part of the tissue closure device.

[0088] The binding force between the needle holding mechanism on each arm and the suture needle 400 changes relatively during the process of exchanging the suture needle 400. In order to smoothly exchange the suture needle 400, the binding force of the needle holding mechanism receiving the suture needle 400 is greater than the needle holding mechanism delivering the suture needle 400. When the two interact, the binding force between the needle holding mechanism receiving the suture needle 400 and the suture needle 400 is greater, and the suture needle 400 can be separated from the original needle holding mechanism, and vice versa. Of course, in order to achieve the above functions, the binding force between the needle holding mechanism on at least one arm and the suture needle 400 is actively adjusted.

[0089] The delivery assembly 200 includes a plurality of delivery shafts that are slidably matched, and each arm is respectively installed on the corresponding delivery shaft, so that each arm can move independently, that is, the relative movement path of the two arms is a straight line parallel to the delivery shaft. Specifically, the delivery assembly 200 includes a first delivery shaft 210 and a second delivery shaft 220 that are slidably matched. The first delivery shaft 210 and the second delivery shaft 220 can be arranged side by side or nested with each other, for example, the second delivery shaft 220 is located inside the first delivery shaft 210. The cross-sectional shape of each delivery shaft is not strictly limited. When no other components are installed inside, the delivery shaft can also be a solid rod.

[0090] The two arms include:

[0091] The first arm 310 is fixed to the distal end 10 of the first delivery shaft 210, that is, the first arm 310 is fixedly arranged relative to the handle through the delivery assembly;

[0092] The second arm 320 is hinged to the distal end 10 of the second delivery shaft 220 , and the distal end 10 of the second delivery shaft 220 extends out of the first delivery shaft 210 .

[0093] The delivery assembly 200 also includes a third delivery shaft 230, which is inserted into the interior of the first delivery shaft 210. For example, a sleeve 211a fixed relatively to the second delivery shaft 220 may be provided in the first delivery shaft 210, and the third delivery shaft 230 is movably inserted in the sleeve 211a. The third delivery shaft 230 is an elastic wire, and the distal end 10 is connected to the second arm 320, driving the second arm 320 to swing relative to the second delivery shaft 220. For example, a mounting hole 321 is provided on the second arm 320, and the distal end 10 of the elastic wire is inserted and fixed in the mounting hole 321, which can be fixed by welding, riveting, etc. The elastic wire can be adaptively bent or straightened at the hinged portion between the second arm 320 and the second delivery shaft 220.

[0094] The proximal end 20 of the third delivery shaft 230 is connected to the corresponding driving mechanism 120. That is, the third delivery shaft 230 can be controlled by the driving mechanism 120 to swing with the second arm 320. Of course, the purpose of the swing is to facilitate the second arm 320 to be straightened and extended into the wound, and to bend at a predetermined position to achieve a spatial posture relative to the first arm 310, so as to facilitate the mutual suture.

[0095] In this embodiment, the first arm 310 is set at an angle relative to the first delivery axis 210, for example, vertically. In order to facilitate the delivery of the suture needle 400, the two arms are set in parallel when working in the wound, so that when one arm delivers the suture needle 400, the other arm is against the tissue, reducing the stress on the surrounding tissue during wound tissue puncture. Further, the swing axis of the second arm 320 relative to the second delivery axis 220 is perpendicular to the extension direction of the second delivery axis 220.

[0096] In order to hold the suture needle 400, the needle holding mechanism 331 includes:

[0097] The needle slot 340 is provided in the corresponding arm for receiving the end of the suture needle 400. In order to avoid interference of the suture 403 when the two needle holding mechanisms are sutured alternately, the suture 403 can be connected to the middle of the length direction of the suture needle 400.

[0098] The specific connection method can be that the suture needle 400 has a thread hole 402 for passing the suture 403, or the end of the suture 403 is bonded to the suture needle 400, or the suture needle 400 is locally deformed to clamp and fix the suture 403, and additional components can also be used for binding and fixing.

[0099] The other end of the suture 403 can extend outward from the inside of the first delivery shaft 210 until it is led out of the handle 100. A threading tube can be provided in the first delivery shaft 210 to limit the extension path of the suture 403 to avoid excessive winding, etc.

[0100] The fixed protrusion 350 is convexly arranged on the inner wall of the needle groove 340 to squeeze the outer peripheral wall of the sewing needle 400. Accordingly, the sewing needle 400 may have a groove 401 that matches the fixed protrusion 350. Of course, in order to increase the pre-tightening force between the sewing needle 400 and the needle holding mechanism 331, the needle holding mechanism 331 also includes an elastic member 360. The elastic member 360 and the fixed protrusion 350 act on both sides of the radial direction of the sewing needle 400. The side wall of the needle groove 340 may be provided with a card slot 341, and the elastic member 360 is fixedly placed in the card slot 341. Further, the elastic member 360 partially convexly projects toward the side of the needle groove 340, so that a certain force is required when the sewing needle 400 is inserted into or out of the needle groove 340 to prevent it from being easily out of the way.

[0101] In one embodiment, the binding force between the needle holding mechanism and the suture needle 400 is actively adjusted. For example, in the first arm 310, the needle holding mechanism 330 includes:

[0102] A needle slot 340 is provided in the arm for receiving the end of a sewing needle 400;

[0103] The movable pin 370 and the outer peripheral wall of the suture needle 400 are provided with a coupling groove 410 , and the movable pin 370 matches with the coupling groove 410 .

[0104] The needle groove 340 roughly matches the size of the suture needle to avoid being too loose and to facilitate positioning. In this embodiment, the diameter of the suture needle is 0.5mm~1mm, and the total length is approximately 7mm. The general preset value from skin to blood vessel is 5mm~6mm, which can be reduced to less than 4mm by squeezing. Therefore, the suture needle length of this embodiment is more suitable.

[0105] Compared with the needle holding mechanism 330 , the needle holding mechanism 331 fixes the suture needle by means of the fixed protrusion 350 , which can be regarded as a passive adjustment method, that is, the operator cannot actively control the fixed protrusion 350 .

[0106] The active adjustment method can be implemented not only in the first arm 310, but also in the second arm 320, and even the needle holding mechanisms in both arms can be adjusted in an active manner. The operation steps, component structure, and size can be adjusted accordingly.

[0107] The delivery assembly 200 further includes a fourth delivery shaft 240, the distal end 10 of the fourth delivery shaft 240 is connected to the movable pin 370, and the proximal end 20 of the fourth delivery shaft 240 is connected to the corresponding driving mechanism 120. The fourth delivery shaft 240 is arranged inside the first delivery shaft 210, for example, a sleeve 211b fixed relatively to the first delivery shaft 210 may be arranged inside the first delivery shaft 210, and the fourth delivery shaft 240 is movably arranged inside the sleeve 211b.

[0108] In this embodiment, the needle holding mechanism 330 is disposed on the first arm 310 , and the needle holding mechanism 331 is disposed on the second arm 320 .

[0109] refer to Figure 8a to Figure 8d , the principle of the needle holding mechanism is explained below in conjunction with the interactive suture process. During the specific operation, the second arm 320 is extended into the wound of the tissue 404 (at this time, the axis of the second arm 320 and the second delivery shaft 220 are roughly on the same straight line), and then the third delivery shaft 230 is driven to make the second arm 320 perpendicular to the extension direction of the second delivery shaft 220, and then the first delivery shaft 210 is driven to make the suture needle 400 of its needle holding mechanism 330 puncture the tissue 404 until the suture needle 400 is combined with the fixed protrusion 350 of the needle holding mechanism 331, and at this time, the fourth delivery shaft 240 is driven to disengage the movable pin 370 from the coupling groove 410, and the suture needle 400 is held by the needle holding mechanism 331.

[0110] During the next interaction, the second delivery shaft 220 is driven to move the needle holding mechanism 331 toward the first arm 310 until the suture needle 400 abuts against the needle holding mechanism 331. At this time, the movable pin 370 is matched with the coupling groove 410, and the first arm 310 is lifted. Since the binding force between the movable pin 370 and the coupling groove 410 is greater than the binding force between the groove 401 and the fixed protrusion 350, the suture needle 400 is separated from the second arm 320 and moves with the first arm 310. Repeat the above steps to complete the interactive suture needle. Figures 9 to 12 , the handle 100 comprises:

[0111] The housing 110, the proximal end 20 of the delivery assembly 200 is movably inserted into the housing 110, and the housing 110 can be in a split buckle-fitting manner;

[0112] A plurality of drive mechanisms 120 respectively control corresponding delivery axes.

[0113] The driving mechanism 120 is configured for at least two arms:

[0114] Two operating handles, one end of each operating handle extends out of the operating end 122 of the housing 110, and the other end is hinged in the housing 110 through a pivot 130, and the two operating handles are respectively an operating handle 121a for controlling the second delivery shaft 220 and an operating handle 121b for controlling the first delivery shaft 210;

[0115] A connecting rod is hinged between the corresponding operating handle and the delivery shaft.

[0116] In order to facilitate one-handed operation, the operating end 122 is ring-shaped, which can be inserted by a single finger. The housing 110 has a clearance opening 126 for avoiding the operating handle. The operating handle is located in the housing 110 and a blocking piece 127 is fixed near the clearance opening 126, so that when the operating handle moves, the blocking piece 127 always blocks the clearance opening 126. In one embodiment, the distal end of the housing 110 converges into a tubular shape to guide the movement of the first delivery shaft 210.

[0117] The driving mechanism 120 further includes a dial button for driving the third delivery shaft 230 and the fourth delivery shaft 240 respectively. The shape of the dial button is not limited to being a sliding force-applying member. For ease of operation, a window 111 for avoiding the dial button is provided on the housing 110. For ease of distinguishing the two dial buttons, the two dial buttons are arranged on opposite sides of the driving mechanism 120 and are arranged at intervals in the height direction, wherein the dial button 124a driving the third delivery shaft 230 is located higher than the other dial button 124b.

[0118] refer to Figures 13 to 19 The proximal ends 20 of the first delivery shaft 210 and the second delivery shaft 220 are respectively fixed with connecting seats, and each dial button is slidably installed on the corresponding connecting seat.

[0119] A gear position limiting structure that cooperates with each other is provided between the dial button and the corresponding connecting seat. For example, the connecting seat 212a has a plurality of adjustment positions 214, which are slots in the figure, and the dial button 124a has a protrusion 128 that cooperates with the adjustment position 214. When the dial button 124a slides, the protrusion 128 can be placed in the adjustment position 214 at different positions to achieve positioning.

[0120] The connection seat 212b is provided with a positioning block 215, and the dial button 124b is provided with a plurality of positioning holes 129 that match the positioning block 215. The positioning holes 129 are arranged along the axial direction of the delivery axis. When the dial button 124b slides, the positioning block 215 can be placed in the positioning holes 129 at different positions and achieve positioning. Of course, the specific number of the adjustment position 214 and the positioning hole 129 is not required and can be set according to the needs. In this embodiment, the number of the adjustment position 214 and the positioning hole 129 is 2 respectively.

[0121] The operating handle and the corresponding delivery shaft are also transmitted through a connecting seat. For example, the operating handle is provided with a laterally extending support at a position adjacent to the pivot 130, and the operating end and the support are on the same side of the pivot 130. The connecting rod is hinged between the corresponding support and the connecting seat. In the figure, the operating handle 121a is provided with a support 125a, and the support 125a is connected to the connecting seat 212a through the connecting rod 123a, thereby realizing the transmission from the operating handle 121a to the second delivery shaft 220.

[0122] Similarly, the operating handle 121b is provided with a support 125b, and the support 125b is connected to the connecting seat 212b via a connecting rod 123b, thereby realizing the transmission from the operating handle 121b to the first delivery shaft 210.

[0123] In order to facilitate the extension of the third delivery shaft 230 and the fourth delivery shaft 240, the connection seat 212a has a mounting hole 213a, one end of the third delivery shaft 230 is fixed to the dial button 124a, and enters the sleeve 211a through the mounting hole 213a. The connection seat 212b has a mounting hole 213b, one end of the fourth delivery shaft 240 is fixed to the dial button 124b, and enters the sleeve 211b through the mounting hole 213b.

[0124] refer to Figure 20 to Figure 24 The proximal ends 20 of the first delivery shaft 210 and the second delivery shaft 220 are provided with mutually matching interlocking structures 250, so that either one of them can move. That is, relative to the housing 110, the interlocking structure 250 only allows one (the operating handle 121a or the operating handle 121b) to move.

[0125] The interlocking structure 250 includes:

[0126] A holder 251 fixed to one of the delivery shafts. The holder 251 is a frame structure as a whole, and a guide slide 252 is provided inside. In this embodiment, the holder 251 is fixed to the connecting seat 212a at the top of the second delivery shaft 220;

[0127] The limiting member 253 is fixed to the operating handle 121 b linked to the first delivery shaft 210 , and the limiting member 253 has a limiting head 255 inserted into the guide slide 252 .

[0128] One end of the limiting member 253 extends to the retaining frame 251 and has a limiting head 255 . The limiting head 255 is hook-shaped and has an extension portion 2551 protruding from the limiting member 253 toward the guide slide 252 . The limiting head 255 is inserted into the guide slide 252 through the extension portion 2551 .

[0129] The guide slideway 252 includes a first slideway 2521 and a second slideway 2522 which are connected to each other, wherein:

[0130] The extension direction of the first slideway 2521 is consistent with the movement direction of the retaining frame 251 relative to the handle 100;

[0131] The extension direction of the second slideway 2522 is consistent with the movement direction of the limiting head 255 relative to the handle 100 .

[0132] The first slideway 2521 and the second slideway 2522 are connected via an intersection area 256 having a shape corresponding to the limiting head 255 .

[0133] The guide slide 252 is roughly "r"-shaped. When the operating handle 121b drives the limit member to the end of the second slide 2522, the limit head 255 is engaged with the two sides of the second slide 2522. At this time, the retaining frame 251 cannot move up and down (that is, along the axial direction of the delivery axis, the distal position is down and the proximal position is up), that is, the operating handle 121a is in a locked state, and when the limit head 255 moves with the operating handle 121b and is in the intersection area 256, the shape of the intersection area 256 is adapted to the shape of the limit head 255, which can avoid the limit head 255 from shaking and misaligning relative to the retaining frame 251, and only allow the retaining frame 251 to move relatively downward.

[0134] Once the retaining frame 251 moves downward relatively, that is, the limiting head 255 enters the first slideway 2521, since both sides of the first slideway 2521 abut against the limiting head 255, the operating handle 121b is in a locked state, that is, the interlocking structure 250 can only move one way.

[0135] The interlocking structure 250 can facilitate the relative stability of the spatial posture of the shell 110 and the distal part when operated with one hand, avoiding the need to use the other hand or other auxiliary tooling for fixation during use, reducing the possibility of misoperation, making the operation simpler and more convenient for one-handed use.

[0136] To further illustrate the principle of the interlocking structure 250, the following table shows the corresponding delivery axis and arm movement direction when each operating handle swings. The relative position relationship of each component can be referred to Figure 25a to Figure 25e The changes in the position of the sewing needle are also shown in each figure. For the interaction process of the sewing needle, please refer to the above.

[0137]

[0138] The above embodiments are based on two clamping arms that cooperate with each other to implement suturing. In other embodiments, a single-arm structure can also be used, and other instruments can be used in conjunction with the single arm, or even two sets of tissue closure devices with single-arm structures can be used. In the single-arm structure, the movement of the arm can be simplified, and even relative movement of the handle is not required, but at least one needle holding mechanism is actively controlled. Based on this embodiment, a tissue closure device is also provided, reference Figure 26-27 , having opposite distal and proximal ends 10 and 20, the tissue closure device comprises:

[0139] The handle 100 is provided with a driving mechanism 120;

[0140] The delivery assembly 200 has a shape suitable for intervention and is proximally connected to the handle 100;

[0141] An arm is mounted at the distal end of the delivery assembly 200, and a needle holding mechanism is provided on the arm, and the needle holding mechanism includes:

[0142] A needle slot 340 is provided in the arm for receiving a suture needle 400 in a detachable manner;

[0143] The movable pin 370 is passed through the arm, and one end of the movable pin is a working end 371 for locking or releasing the suture needle 400.

[0144] The needle slot 340 and the movable pin 370 can be matched in the same manner as in the above embodiments, for example, the inner wall of the needle slot 340 is provided with a pin hole, the working end 371 of the movable pin 370 can move in and out of the pin hole, and the arm is provided with an extension channel 380 connected to the pin hole, and the other end opposite to the working end 371 of the movable pin 370 extends toward the proximal end through the extension channel 380 and is controlled by a corresponding driving mechanism. The driving mechanism can use a control component movably mounted on the handle 100 to drive the movable pin 370, and can be specifically combined with the above embodiments.

[0145] The arm in this embodiment can utilize the first delivery axis and be fixed to the distal end of the first delivery axis, or can be hingedly mounted to the distal end of the first delivery axis and driven to flip using the third delivery axis.

[0146] In this embodiment, the suture needle 400 is detachable from the arm and the movable pin in the needle holding mechanism is used to lock or release the suture needle 400. Of course, this embodiment can also be combined with the two-arm structure mentioned above to cooperate with each other to implement suturing.

[0147] refer to Figure 28 to Figure 30 This embodiment also discloses a tissue closing method for closing a suture area 420 on a tissue 404 by using a suture 403. The tissue closing device of each embodiment described above may be used in the specific implementation. The tissue closing method includes:

[0148] The suture 403 is threaded along the edge of the suture area 420 multiple times in a sinking and floating manner. With respect to the tissue, threading downward is sinking, and threading upward is floating. For details, please refer to Figure 29 to Figure 30 The suture 403 sinks under the tissue 404 at the O-shaped mark and floats above the tissue 404 at the X-shaped mark. The operation of the tissue closure device during each threading can be referred to above and will not be repeated here.

[0149] After the suture 403 is threaded, the two ends of the suture 403 are tightened and knotted to keep the suture area 420 closed.

[0150] In this embodiment, in combination with the extension direction of the suture 403 relative to the suture area 420, a purse-string pre-embedded suture is adopted. This suturing method reduces the probability of device failure and is particularly suitable for large-caliber tissues.

[0151] The tissue closure method of the present application can perform single-needle reciprocating multi-point suturing. After all the sutures are buried around the tissue wound that needs to be sutured, the suture 403 is tightened, and the wound is tightened accordingly to complete the suturing, and the sealing performance is better.

[0152] The tissue closure device and tissue closure method of the present application can achieve large-caliber tissue suturing by continuous needle removal and multi-point suturing, reduce the operation of exchanging instruments during surgery, simplify the surgical process and reduce the risk of infection.

[0153] The technical features of the above-mentioned embodiments can be combined arbitrarily. To make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification. When the technical features in different embodiments are embodied in the same figure, it can be regarded that the figure also discloses the combination examples of the various embodiments involved.

[0154] The above-mentioned embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the patent application. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application.

Claims

1. A tissue closure device having opposed distal and proximal ends, characterized in that: The tissue closure device comprises: A handle, configured with a driving mechanism; a delivery assembly having a shape suitable for intervention and connected proximally to the handle; An arm is mounted at the distal end of the delivery assembly, and a first needle holding mechanism is provided on the arm, wherein the first needle holding mechanism comprises: A needle slot, provided in the arm, for receiving a suture needle in a detachable manner; A movable pin is passed through the arm, and one end of the movable pin is a working end for locking or releasing the sewing needle.

2. The tissue closure device according to claim 1, characterized in that: The tissue closing device also includes a single suture needle, which is in the shape of a straight rod and has two opposite ends, each end of which can be detachably plugged into a corresponding needle holding mechanism.

3. The tissue closure device according to claim 2, characterized in that: The outer peripheral wall of the sewing needle is provided with a coupling groove, and the movable pin matches with the coupling groove.

4. The tissue closing device according to claim 3, characterized in that: The inner wall of the needle groove is provided with a pin hole, and the working end of the movable pin can move in and out of the pin hole; The arm has an extension channel in the interior thereof which is connected with the pin hole. The other end of the movable pin opposite to the working end extends toward the proximal end via the extension channel and is controlled by a driving mechanism.

5. The tissue closing device according to claim 1, characterized in that: There are two arms, one of which is provided with the first needle holding mechanism, and the other is provided with the second needle holding mechanism, wherein the second needle holding mechanism comprises: A needle slot, provided in the arm, for receiving a suture needle in a detachable manner; A fixed convex point is convexly arranged on the inner wall of the needle groove to squeeze the outer peripheral wall of the sewing needle; The elastic member and the fixed protrusion act on both sides of the sewing needle in the radial direction.

6. The tissue closing device according to claim 5, characterized in that: The delivery assembly includes a first delivery shaft that is slidably fitted and a second delivery shaft that is within the first delivery shaft, and the two arms include: a first arm fixed to the distal end of the first delivery shaft; The second arm is hinged to the distal end of the second delivery shaft, and the distal end of the second delivery shaft extends beyond the first delivery shaft.

7. The tissue closing device according to claim 6, characterized in that: A swing axis of the second arm relative to the second delivery axis is perpendicular to an extension direction of the second delivery axis.

8. The tissue closing device according to claim 6, characterized in that: The delivery assembly further includes a third delivery shaft, the third delivery shaft is disposed inside the first delivery shaft, the distal end of the third delivery shaft is connected to the second arm, and drives the second arm to swing relative to the second delivery shaft; The proximal end of the third delivery shaft is connected to a corresponding driving mechanism.

9. The tissue closing device according to claim 8, characterized in that: The delivery assembly also includes a fourth delivery shaft, the distal end of the fourth delivery shaft is connected to the movable pin, and the proximal end of the fourth delivery shaft is connected to a corresponding driving mechanism.

10. A tissue closing method implemented by the tissue closing device according to any one of claims 1 to 9, for closing a sutured area on a tissue by means of sutures, comprising: The suture is passed along the edge of the suture area several times in a sinking and floating manner; Tighten the two ends of the suture and tie a knot to keep the suture area closed.

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