Closing device for tissue suturing and tissue closing method

Abstract

The invention discloses a closing device for tissue suturing and a tissue closing method.The closing device for tissue suturing is provided with a far end and a near end which are opposite, and the closing device comprises a handle provided with a driving mechanism; the near end of the catheter is fixed on the handle; the two operating arms are connected to the far end of the catheter, each operating arm is controlled by the driving mechanism, each operating arm is provided with a needle holding mechanism, and each operating arm is provided with a connecting end matched with the catheter in a rotating mode and a free end swinging around the rotating axis; and the free ends of the two operating arms are interacted through respective needle holding mechanisms in the relative swinging process and are used for threading a suture needle of a suture to tissues. According to the closing device, more tissue closing scene requirements can be met by improving the movement modes of the two operation arms, and in addition, the operation synchronism and the structure simplification are guaranteed by aiming at the arrangement of the driving mechanism.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a closure device and a tissue closure method for suturing tissue. 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, and produce fewer complications.

[0003] The existing vascular closure devices can be roughly divided into three categories according to the hemostatic treatment method: suturing, embolization, and staple clips. Embolization often uses degradable substances. Although this method may be effective, there are many problems, such as the inability to provide hemostasis due to poor embolization positioning, and the subsequent formation of hematoma and / or pseudoaneurysm; possible embolism downstream, causing vascular occlusion; thrombosis on the surface of the embolic body protruding into the lumen causes stenosis and obstructs normal blood flow. Staple clip products are limited by the shape and size of the staple clip itself, usually with a fixed caliber and a small caliber.

[0004] Although suturing has been significantly improved compared to manual compression and the use of staple clips and embolization-type vascular closure devices, the existing technology still has the following defects:

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

[0006] When the suture is inserted, if the needle hits a hard object such as calcification, and the force applied is large 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 closure device and a tissue closure method for tissue suturing, and is more suitable for suturing large-caliber tissues.

[0011] The present application discloses a closure device for tissue suturing, which has a distal end and a proximal end opposite to each other, and comprises:

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

[0013] a catheter, the proximal end of which is fixed to the handle;

[0014] Two operating arms are connected to the distal end of the catheter, each operating arm is controlled by the driving mechanism, and each operating arm is provided with a needle holding mechanism. The operating arm has a connecting end that rotates with the catheter and a free end that swings around a rotation axis. The free ends of the two operating arms are used to interactively guide the suture needles of the suture into the tissue through their respective needle holding mechanisms during the relative swinging process.

[0015] 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.

[0016] Optionally, the catheter has a first axis extending at the distal end and the proximal end, the rotation axis of the operating arm is a second axis, and the angle between the second axis and the first axis is 45 to 90 degrees; the two operating arms swing around the same axis.

[0017] Optionally, the two operating arms have a first state in which the free ends are away from each other, and a second state in which the free ends are close to each other;

[0018] An elastic member is provided between the two operating arms, or between the conduit and at least one operating arm, for acting on at least one operating arm to move toward the first state.

[0019] Optionally, the elastic member is fixed to one of the operating arms and movably abuts against the other operating arm; or the two operating arms are respectively provided with the elastic member, and in the second state, the elastic members of the two operating arms approach and abut against each other.

[0020] Optionally, two traction cables are configured for the same operating arm, the proximal end of each traction cable is connected to the corresponding driving mechanism, the distal end of each traction cable is connected to the operating arm, and the proximal end of each traction cable moves synchronously to drive the operating arm to switch states.

[0021] Optionally, for the same operating arm, the distal ends of the traction cables are respectively fixed to the operating arm, or are mutually intersected into an integrated structure;

[0022] The operating arm is provided with a receiving groove at a position adjacent to the connecting end, and at least a part of the traction rope is fixed in the receiving groove.

[0023] Optionally, the binding force between the needle holding mechanism on each operating arm and the suture needle may vary relatively during the interactive suture process; the binding force between the needle holding mechanism on at least one operating arm and the suture needle is actively adjusted.

[0024] Optionally, the needle holding mechanism comprises:

[0025] A needle slot is provided on the operating arm and is used to receive the end of the sewing needle;

[0026] A movable pin is arranged in the catheter, the outer peripheral wall of the suture needle is provided with a coupling groove, the distal end of the movable pin matches with the coupling groove, and the proximal end of the movable pin is connected to the corresponding driving mechanism.

[0027] Optionally, the movable pins on the two operating arms move synchronously to switch the matching state with the sewing needle;

[0028] A pin hole is formed on the slot wall of the needle slot, and the distal end of the movable pin enters or withdraws from the needle slot via the pin hole.

[0029] The present application also provides a tissue closure method implemented based on the closure device described in the present application, which is used to close the suture area on the tissue by means of sutures, comprising:

[0030] The suture is passed along the edge of the suture area several times in a sinking and floating manner;

[0031] Tighten the two ends of the suture and tie a knot to keep the suture area closed.

[0032] The closure device of the present application can be adapted to more tissue closure scenario requirements by improving the movement mode of the two operating arms. In addition, the setting of the driving mechanism ensures the synchronization of operation and the simplification of structure. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 A schematic diagram of the structure of a closing device according to an embodiment of the present application;

[0034] Figure 2 A schematic structural diagram of a closing device according to an embodiment of the present application from another perspective;

[0035] Figure 3 An exploded view of a closing device according to an embodiment of the present application;

[0036] Figure 4 for Figure 3 A magnified view of middle;

[0037] Figure 5 is a schematic structural diagram of the free ends of the two operating arms being in a first state;

[0038] Figure 6is a schematic structural diagram of the free ends of the two operating arms being in the second state;

[0039] Figure 7 It is a schematic diagram of the structure of two operating arms;

[0040] Figure 8 It is a schematic diagram of a structure in which two traction members are on the same operating arm;

[0041] Fig. 9 It is a schematic diagram of a structure in which there is only one traction member on the same operating arm;

[0042] Fig.10 is a cross-sectional view of a manipulator arm;

[0043] Fig.11a is a schematic diagram of the structure of a suture needle;

[0044] Fig.11b for Fig.11a Schematic diagram of the mechanism of the suture needle from another perspective;

[0045] Fig.12 for Figure 1 Schematic diagram of the structure of the middle catheter;

[0046] Figure 13a to Figure 13g It is a schematic diagram of the structure of each operating arm when the sewing needle interacts;

[0047] Fig.14 A partial exploded view of a closing device according to an embodiment of the present application;

[0048] Fig.15 A schematic diagram of a portion of the structure of a closing device provided in an embodiment of the present application when half of the shell is omitted;

[0049] Fig.16 is a structural schematic diagram of a second driving mechanism;

[0050] Fig.17 for Fig.16 Schematic diagram of the structure after the middle operating component is pressed;

[0051] Fig.18a for Fig.16 A cross-sectional view of the second driving mechanism;

[0052] Fig.18b for Fig.16 Exploded view of the switch;

[0053] Fig.19 A cross-sectional view of a closure device according to an embodiment of the present application with the catheter omitted;

[0054] Fig. 20 It is a structural schematic diagram of the cooperation between the two first driving mechanisms and the linkage mechanism;

[0055] Fig.21a for Fig. 20 An exploded view of the first driving mechanism and the linkage mechanism;

[0056] Figure 21b for Fig. 20 A schematic diagram of the structure in which the driven members of the two first driving mechanisms are connected to the traction members;

[0057] Fig. 22 is a schematic diagram of the structure of the drive ring;

[0058] Fig.23 is a schematic diagram of the structure of the outer tube;

[0059] Fig.24 A flowchart of a tissue closure method according to an embodiment of the present application;

[0060] Fig.25 A schematic diagram of the process of suturing tissue using an existing closure device;

[0061] Fig.26 A schematic diagram of the process of suturing tissue using a closure device according to an embodiment of the present application.

[0062] The reference numerals in the figures are described as follows:

[0063] 11. distal end; 12. proximal end;

[0064] 100, handle; 110, housing; 111, slideway; 112, blocking step; 120, driving mechanism; 130a, first driving mechanism; 130b, first driving mechanism; 131, active member; 131a, active member; 131b, active member; 132, operating part; 133, driven member; 133a, driven member; 133b, driven member; 133c, driven member; 133d, driven member; 140, second driving mechanism; 141a, linkage block; 141b, linkage block; 142, operating assembly; 14 3. Synchronous parts; 144. Switch; 145. Avoidance hole; 146. Channel; 148. Reset assembly; 149. Positioning column; 150. Linkage mechanism; 151. Inner tube; 152. Outer tube; 153. Shrapnel; 154. Driving ring; 155. Protruding structure; 156. Buffer sleeve; 157. Anti-skid teeth; 158. Friction plate; 159. Slot; 160. Bump; 161. Push rod; 162. Bottom cover; 163. Ratchet seat; 164. Button; 165. Rotating shaft; 166. Inner spring; 167. Outer spring;

[0065] 200, catheter; 210, traction member; 210a, traction member; 210b, traction member; 210c, traction member; 210d, traction member; 220, cavity; 220a, cavity; 220b, cavity; 220c, cavity; 220d, cavity; 220e, cavity; 220f, cavity; 220g, cavity;

[0066] 300, operating arm; 300a, operating arm; 300b, operating arm; 301, connecting end; 302, free end; 303, accommodating groove; 310a, needle holding mechanism; 310b, needle holding mechanism; 311, needle groove; 312, movable pin; 312a, movable pin; 312b, movable pin; 313, pin hole; 314, extension channel; 320, elastic member; 321, avoidance hole;

[0067] 400, suture needle; 401, suture thread; 402, coupling groove; 410, tissue wound; 411, suture area. DETAILED DESCRIPTION

[0068] 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.

[0069] 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.

[0070] 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.

[0071] 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 the present invention, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0072] 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.

[0073] An embodiment of the present application provides a closure device for tissue suturing. With regard to the improvement of its structure, it is particularly suitable for suturing large-caliber tissues. 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.

[0074] refer to Figure 1 to Figure 4 , a closure device for tissue suturing, having a distal end 11 and a proximal end 12 opposite to each other, specifically comprising:

[0075] The handle 100 is provided with a driving mechanism 120;

[0076] The catheter 200 has a proximal end fixed to the handle 100;

[0077] Two operating arms 300 are connected to the distal end of the catheter 200, and each operating arm 300 is controlled by a driving mechanism 120. Each operating arm 300 is provided with a needle holding mechanism. The operating arm 300 has a connecting end 301 that rotates with the catheter 200 and a free end 302 that swings around a rotation axis. During the relative swinging process, the free ends 302 of the two operating arms 300 are interactively used to guide the suture needle 400 of the suture 401 into the tissue through their respective needle holding mechanisms 310.

[0078] The distal end 11 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 12 corresponds to the end close to the operator. The handle 100 is used for holding, and the traction member 210 is controlled by the driving mechanism 120, so that the corresponding needle holding mechanisms of the two operating arms 300 alternately suture the tissue 401.

[0079] The interactive suture 401 can be understood as the tissue to be sutured is located between two needle holding mechanisms, one of the needle holding mechanisms 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 (the suture needle 400 correspondingly detaches from the original needle holding mechanism), and then the other needle holding mechanism moves to the next position, punctures the tissue again and delivers the suture needle 400 to the original needle holding mechanism, and the above steps are repeated to complete multiple threadings.

[0080] In this embodiment, the two operating arms 300 are movably arranged relative to the catheter 200, that is, they swing around the rotation axis. The rotation axes of the two operating arms 300 can be arranged in parallel, either collinearly or non-collinearly. When swinging, the free end 302 has a larger displacement relative to other positions of the operating arm, which can adapt to different tissue thicknesses at the puncture site.

[0081] The 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 closure device, which is more convenient and quick to operate.

[0082] The catheter 200 has a first axis extending between the distal end 11 and the proximal end 12, and the rotation axis of the operating arm is the second axis (the first axis and the second axis can be specifically referred to in Figure 4 In the figure, the angle between the second axis and the first axis is 45 to 90 degrees, for example, 75 to 90 degrees, and is substantially 90 degrees.

[0083] In order to simplify the structure, the two operating arms 300 swing around the same axis, for example, they are mounted on the distal end 11 of the catheter 200 through the same pivot (that is, the operating arms 300 swing around the second axis). Since the two operating arms 300 have a certain angle limit when rotating at the free end 302 when the two operating arms 300 alternately sew the needle 400, the two operating arms 300 can be symmetrically arranged relative to the first axis to ensure the necessary opening range.

[0084] refer to Figures 5 to 9 , there is a first state between the two operating arms 300 in which the free ends 302 are away from each other, and a second state in which the free ends 302 are close to each other. In order to maintain the first state of the two, an elastic member 320 is provided between the two operating arms 300, or between the catheter 200 and at least one operating arm, which acts on at least one operating arm to move toward the first state. Specifically, the elastic member 320 is fixed to one of the operating arms, and movably abuts against the other operating arm. Further, one end of the elastic member 320 is fixed to a position adjacent to the connection end 301 of the operating arm, and the other end of the elastic member 320 movably abuts against a position adjacent to the free end 302 of the other operating arm.

[0085] In another embodiment, the two operating arms 300 are respectively provided with elastic members 320. In the second state, the elastic members 320 of the two operating arms 300 approach each other and deform to store energy, which is used to assist in driving the two operating arms 300 to reset, that is, enter the first state. In the first state, the elastic members 320 are separated from each other. Preferably, in the first state, the distal ends 11 of the two elastic members 320 are arranged in parallel, and the parallel arrangement can have a certain gap for the two free ends to approach each other, and can also be used to clamp tissues to reduce deformation of the suture needle 400 during puncture.

[0086] In order to facilitate the sewing needle 400 to pass through the elastic member 320 , the operating arm 300 is provided with a needle groove 311 for receiving the sewing needle 400 at a position adjacent to the free end 302 , and the elastic member 320 is provided with an avoidance hole 321 corresponding to the position of the needle groove 311 .

[0087] Considering the problem of facilitating the connection between the traction member 210 and the operating arm 300, the operating arm 300 is provided with a receiving groove 303 at a position adjacent to the connecting end 301. The traction member 210 is a flexible member and the distal end 11 is wound around the corresponding receiving groove 303. At least a portion of the traction member 210 can be fixed to the receiving groove 303 or tightened in a tight fit manner, both of which can drive the operating arm 300.

[0088] In one embodiment, for the same operating arm 300, the traction member 210 is two traction cables, the proximal end of each traction cable is connected to the corresponding driving mechanism 120, the distal end of each traction cable is connected to the operating arm 300, and the proximal end of each traction cable moves synchronously to drive the operating arm to switch states. When moving synchronously, they have opposite movement trends, for example, one traction cable is delivered to the distal end, and the other traction cable is withdrawn to the proximal end, which just conforms to the movement trend of both sides of the operating arm, ensuring the accuracy of movement control.

[0089] In another embodiment, for the same operating arm 300, the distal ends of the traction cables are respectively fixed to the operating arm 300, and the distal ends of the two traction cables can also intersect each other to form an integrated structure, that is, the entire structure is one, but can be dynamically divided into two according to the movement trend. At least a portion of the traction member 210 is fixed to the receiving groove 303. For example Fig. 9 In the figure, the traction rope is just one rope in terms of component composition, but there are two ropes in terms of movement trend. When one rope moves toward the proximal end, the other rope moves toward the distal end, and as the movement changes, the intersection of the two ropes is dynamic.

[0090] The binding force between the needle holding mechanism on each operating arm 300 and the suture needle 400 can be relatively changed 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 operating arm and the suture needle 400 is actively adjusted.

[0091] refer to Figure 10 to Figure 12 In order to hold the suture needle 400, the needle holding mechanism includes:

[0092] The needle slot 311 is provided in the operating arm 300 and is used to receive the end of the sewing needle 400. In order to avoid interference of the sewing thread 401 when the two needle holding mechanisms mutually sew the sewing thread 401, the sewing thread 401 is connected to the middle of the length direction of the sewing needle 400, for example, by tying, bonding, setting a needle hole for threading, etc.;

[0093] The movable pin 312 is disposed in the catheter 200 , and the outer peripheral wall of the suture needle 400 is provided with a coupling groove 402 . The distal end of the movable pin 312 cooperates with the coupling groove 402 , and the proximal end of the movable pin 312 is connected to the corresponding driving mechanism 120 .

[0094] In a preferred embodiment, the catheter 200 is a multi-lumen tube, and each of the puller, the movable pin 312 , and the suture 401 extends through an independent lumen 220 .

[0095] For example, the cross section of the catheter 200 has a total of 7 lumens 220 (see Fig.12 ), the two proximal ends of the movable pin 312 (i.e., movable pin 312a and movable pin 312b) are connected to the corresponding driving mechanism through the cavity 220a and cavity 220b respectively, and the traction member (i.e., traction member 210a and traction member 210b) that controls one of the operating arms 300 is connected to the corresponding driving mechanism through the cavity 220c and cavity 220d. Similarly, the traction member (i.e., traction member 210c and traction member 210d) that controls the other operating arm is connected to the corresponding driving mechanism through the cavity 220e and cavity 220f. One end of the suture 401 is fixed to the suture needle 400, and the other end extends through the cavity 220g. Of course, the specific connection method is not unique and can be set according to needs. The above embodiments are only for reference, and this application does not make specific limitations.

[0096] The suture needle 400 is in the shape of a straight rod or a curved rod. Of course, in order to cooperate with the movement of the two operating arms, both ends of the suture needle 400 are bent in the same direction, roughly in an arc shape. The arc is greater than 0 and less than or equal to 1 (unit is π), for example, 1 / 8 to 5 / 8, and another example is 3 / 8 to 4 / 8. The length of the suture needle along its own extension direction is 5-8mm, and the outer diameter (OD) is 0.6-0.8mm. For example, the length is 6mm and the OD is 0.7mm.

[0097] In order to simplify the operation, the movable pins 312 on the two operating arms 300 move synchronously to switch the matching state with the suture needle 400. That is, both ends of the suture needle 400 are provided with a coupling groove 402 respectively matched with the two operating arms 300, and when the movable pin 312 moves, it can be matched with the corresponding coupling groove 402 respectively. Specifically, when the needle holding mechanism of the delivery suture needle 400 interacts with the needle holding mechanism of the receiving suture needle 400, the movable pin 312 is adjusted. At this time, the movable pin 312 in the needle holding mechanism of the delivery suture needle 400 is disengaged from the coupling groove 402, and the movable pin 312 in the needle holding mechanism of the receiving suture needle 400 extends into the corresponding coupling groove 402, that is, the suture needle 400 and the original needle holding mechanism 310 are released from the force and allowed to be separated, and vice versa.

[0098] In another embodiment, a pin hole 313 is opened on the groove wall of the needle groove 311, and an extension channel 314 connected to the pin hole 313 is provided inside the operating arm 300. The movable pin 312 is inserted into the extension channel 134, and the distal end of the movable pin 312 enters or withdraws from the needle groove 311 through the pin hole 313.

[0099] In this embodiment, the needle holding mechanism 310a is disposed on the operating arm 300a, and the needle holding mechanism 310b is disposed on the operating arm 300b.

[0100] refer to Figures 13a to 13g The principle of the needle holding mechanism is explained below in conjunction with the process of interacting the suture needles 400. During the specific operation, the operating arm 300a is extended into the tissue wound 410 (at this time, the two operating arms are in the first state, and the suture needle 400 is set on the operating arm 300b), and then the traction member 210 is adjusted by the driving mechanism 120 to make the suture needles 400 interact (the two operating arms are in the second state), and then the movable pin 312 is driven to make the suture needle 400 engage with the operating arm 300a and disengage from the operating arm 300b. At this time, when the two operating arms are restored to the first state, the suture needle 400 is held by the needle holding mechanism 310a.

[0101] During the next interaction, the traction member 210 is driven, the two operating arms interact (the two operating arms are in the second state), and then the movable pin 312 is driven to make the sewing needle 400 combine with the operating arm 300b and detach from the operating arm 300a. At this time, when the two operating arms are set to the first state, the sewing needle 400 is held by the needle holding mechanism 310b, and the above steps are repeated to complete the interaction of the sewing needle 400.

[0102] In the first state, the angle between the two operating arms and the catheter 200 can be pre-adjusted by the traction member 210. For example, the symmetry axis of the two operating arms (which can also be understood as the opening direction of the two operating arms) is used as a reference. The symmetry axis and the catheter 200 can be roughly perpendicular or roughly parallel without strict restrictions.

[0103] refer to Figure 14 to Figure 18b , the handle 100 comprises:

[0104] A housing 110, a proximal end of the catheter 200 is fixed to the housing 110;

[0105] The driving mechanism 120 is configured with multiple sets, which respectively control the corresponding traction members 210 and movable pins 312.

[0106] Specifically, the driving mechanism 120 includes a first driving mechanism for driving the operating arm 300 , and a second driving mechanism 140 for driving the movable pin 312 .

[0107] The first driving mechanism includes two sets (specifically, the first driving mechanism 130a and the first driving mechanism 130b), each corresponding to one of the operating arms. In addition, considering the convenience of operation in actual operation, the driving mechanism 120 is also provided with a linkage mechanism 150 acting between the two sets of first driving mechanisms. When the linkage mechanism 150 acts on the two first driving mechanisms, the two operating arms can realize synchronous and reverse rotation, so as to improve the coordination of the cooperation and reduce the operation steps.

[0108] The second driving mechanism 140 includes:

[0109] Two linkage blocks are slidably mounted in the housing 110, and the proximal ends of the movable pins 312 in each operating arm are respectively connected to the corresponding linkage blocks;

[0110] The operating assembly 142 synchronously drives the two linkage blocks to slide along their respective first directions;

[0111] The reset assembly 148 synchronously drives the two linkage blocks to slide along their respective second directions. For the same linkage member, the first direction is opposite to the second direction. During the movement of the linkage member, the movable pin 312 is correspondingly driven to switch the matching state with the sewing needle 400.

[0112] In this embodiment, the two linkage blocks are arranged opposite to each other, the linkage block 141a is arranged at the near end, and the linkage block 141b is arranged at the far end. Fig.17 , the first direction of the linkage block 141a is X1, and the second direction is Y1; the first direction of the linkage block 141b is X2, and the second direction is Y2. That is, for the linkage block 141a itself, the first direction X1 is opposite to the second direction Y1, and the same is true for the linkage block 141b. Regarding the first direction and the second direction of the two linkage blocks, the first direction X1 in the linkage block 141a and the first direction X2 in the linkage block 141b are opposite to each other. Similarly, the second direction Y1 in the linkage block 141b and the second direction Y2 in the linkage block are opposite to each other. Among them, the proximal end of the movable pin 312a is connected to the linkage block 141a, and the proximal end of the movable pin 312b is connected to the linkage block 141b. Of course, in order to facilitate the connection, a avoidance hole 145 for the movable pin 312a to pass through is also provided on one side of the linkage block 141b to avoid interference with other components. In the initial state, the movable pin 312 is arranged at one end of the suture needle 400 (cooperating with the coupling groove 402). After pressing the operating component 142, the two linkage blocks move away from each other. At this time, the movable pin 312 withdraws from the coupling groove 402 at one end of the suture needle 400 and cooperates with the coupling groove at the other end to realize the switching cooperation between the movable pin 312 and the suture needle 400.

[0113] In one embodiment, the reset assembly 148 is a pair of springs, which act on the corresponding linkage blocks respectively. The two linkage blocks are driven to approach each other. In order to prevent the springs from deflecting during the movement, a positioning column 149 is extended from one end of the two linkage blocks facing away from the operating assembly 142. The springs are respectively inserted into the positioning column 149 and are restrained against the corresponding linkage blocks.

[0114] In order to allow the linkage block to move in a predetermined route, a slideway 111 is provided in the housing 110 , and the two linkage members are slidably fitted in the slideway 111 , and the extension direction of the slideway 111 is the axial direction of the catheter 200 .

[0115] Furthermore, in order to allow the reset assembly 148 to reset itself, blocking steps 112 are provided at both ends of the slideway 111, and one end of each spring abuts against the corresponding blocking step 112, and the other end abuts against the corresponding linkage block. When the operating assembly 142 is pressed, the linkage blocks move toward their respective blocking steps 112, and the springs are compressed at this time. When the force applied to the operating assembly 142 is removed, the linkage blocks reset under the elastic potential energy of the springs.

[0116] The operation component 142 includes:

[0117] The synchronizer 143 is located between the two linkage blocks and has double inclined surfaces, each of which acts on the linkage block on the corresponding side. Accordingly, the matching parts of the linkage block and the synchronizer 143 also adopt inclined surfaces with complementary shapes.

[0118] The switch 144 drives the synchronous member 143 to reciprocate.

[0119] The switch 144 is a linear spring switch. When the linear spring switch is triggered, it drives the synchronizer 143 to press down to separate the two linkage blocks and keep them in the pressed position. When the linear spring switch is triggered next time, the downward pressure is released, allowing the two linkage blocks to move closer to each other and reset under the action of the spring. Of course, the synchronizer 143 can also be operated in other ways to achieve reciprocating motion and state retention.

[0120] As for the linear spring switch itself, existing technology can be used, for example, a push-pull button assembly is used, including a push rod 161, a bottom cover 162, a ratchet seat 163, a button 164, a rotating shaft 165, an inner spring 166 and an outer spring 167. The button 164 has a columnar protrusion on the outside for pressing operation, and the bottom is serrated, which matches the serrated pattern on the outside of the rotating shaft 165. At the same time, the ratchet seat 163 is cylindrical inside and has a track, and the button 164 and the rotating shaft 165 can move in the track. The upper end of the push rod 161 is a bifurcated protrusion, which passes through the notch of the inner cavity of the rotating shaft 165 and is fixed in the rotating shaft 165 through the inner spring 166, and the other end of the inner spring 166 is fixed on the ratchet seat 163. One end of the outer spring 167 is fixed to the lower part of the notch of the rotating shaft 165, and the other end is fixed to the bottom cover 162. The lower part of the push rod 161 is connected to the synchronizer 143, and the synchronizer 143 is located between the two linkage blocks.

[0121] refer to Figure 19 to Figure 21b In one embodiment, the first driving mechanism includes an active member 131 and a driven member 133 that are threaded together, wherein the driven member 133 is fixed to the proximal end of the corresponding traction member 210 .

[0122] The traction member 210 configured for the same operating arm is two traction ropes (the distal end of which may be an integral structure) to control different swing directions. There are two corresponding followers 133, each connected to the proximal end of a corresponding traction rope.

[0123] Specifically, the first driving mechanism 130a includes an active member 131a, a driven member 133a and a driven member 133b, and the first driving mechanism 130b includes an active member 131b, a driven member 133c and a driven member 133d. A hole is provided at the bottom of each driven member, and each traction member (i.e., traction rope) is fixed to the corresponding driven member through each hole. For example, the traction member 210a is connected to the driven member 133a, the traction member 210b is connected to the driven member 133b, the traction member 210c is connected to the driven member 133c, and the traction member 210d is connected to the driven member 133d. Of course, the connection method is not unique and can be set according to needs.

[0124] Furthermore, in order to improve the integration, two corresponding channels 146 are opened in the axial direction of the driven member 133c and / or the driven member 133d to guide the traction member 210a and the traction member 210b to pass through, so as to avoid interference between the traction members.

[0125] Of course, in order to prevent the four traction members from interfering with each other, there are joint surfaces between the same pair of passive members, and the joint surfaces between the two pairs of passive members have an angle, preferably vertical, to facilitate the threading of the traction member 210.

[0126] A portion of the active member 131 itself is exposed to the housing 110 as the operating portion 132 , or a force-applying member is fixed to the active member 131 , and a portion of the force-applying member is exposed to the housing 110 as the operating portion.

[0127] For the same active member 131 , the operating parts are provided at two sides, and are located at two opposite sides of the housing 110 in the radial direction.

[0128] The two sets of first driving mechanisms are arranged axially along the catheter 200. In this embodiment, the active members 131a and the active members 131b of the two sets of first driving mechanisms are arranged adjacent to each other.

[0129] In one embodiment, in order to accurately control the synchronous reverse movement of the two driven members 133 in the same set of first driving mechanism, the active member 131 and the driven member 133 are matched with threads, for example, threads with opposite spiral directions are arranged at different parts of the active member 131. In order to further reduce the axial length of the handle 100, the thread matching adopts Tang's thread, and the inner wall of the same section of the active member 131 is configured with two threads with opposite directions, and the corresponding external threads of the two driven members 133 are in opposite directions. The integrated structure is added, and the operation can be performed with one hand, which simplifies the steps and makes it more flexible.

[0130] The two driven members 133 are radially buckled into a columnar shape and slide relative to each other along the axial direction of the housing 110. For example, the driving member 131 is a sleeve with internal threads, and the driven member 133 includes two semi-cylindrical sliders installed in the sleeve and with external threads.

[0131] On the contrary, the active member 131 may be a screw rod, and the driven member 133 includes two semicircular sliders installed outside the screw rod.

[0132] When the active member 131 is operated, due to the characteristics of the Tang's thread, one of the two driven members 133 moves toward the proximal end 12 and the other moves toward the distal end 11, thereby driving the corresponding traction member 210 to move and causing the operating arm 300 to rotate.

[0133] In order to realize the linkage of the two first driving mechanisms, the linkage mechanism 150 acts between the active components 131 of the two sets of first driving mechanisms.

[0134] The linkage mechanism 150 comprises:

[0135] The inner tube 151 is fixed to the active member 131a of one set of the first driving mechanism 130a;

[0136] The outer tube 152 is fixed to the active member 131b of another set of the first driving mechanism 130b, and is movably sleeved on the outside of the inner tube 151;

[0137] The spring piece 153 is fixed to the outer tube 152;

[0138] The driving ring 154 is sleeved on the outer circumference of the outer tube 152. The inner wall of the driving ring 154 has a protruding structure 155. When the driving ring 154 rotates, the protruding structure 155 acts on the spring piece 153 and correspondingly locks the linked inner tube 151, or unlocks and releases the inner tube 151. In this embodiment, the number of the protruding structures 155 is two, and they are symmetrically distributed.

[0139] A buffer sleeve 156 made of elastic material is further disposed between the inner tube 151 and the outer tube 152 , and the protruding structure 155 is pressed against the outer wall of the inner tube 151 through the buffer sleeve 156 .

[0140] In this embodiment, the spring piece 153 and the outer tube 152 are an integral structure, and the outer periphery of the spring piece 153 is a strip-shaped opening opened in a part of the outer tube 152 to release the deformation stress of the spring piece 153. Considering the increase of friction between the inner and outer tubes 152, the inner side of the spring piece 153 is provided with anti-slip teeth 157.

[0141] One side of the drive ring 154 is provided with a friction plate 158 that acts with the outer tube 152 to rotate with the outer tube 152. The drive ring 154 is correspondingly provided with a slot 159 that matches the friction plate 158, and the friction plate 158 is fixed in the corresponding slot 159. In this embodiment, the number of the friction plate 158 and the slot 159 are both two, and they are symmetrically distributed, so that the circumferential force of the drive ring 154 is more uniform.

[0142] One axial end of the outer tube 152 is provided with a protrusion 160 which is frictionally engaged with the friction plate 158 .

[0143] When the two first driving mechanisms are not linked, the outer tube 152 of the first driving mechanism 130b can drive the driving ring 154 to move together due to the cooperation between the protrusion 160 and the friction plate 158. Therefore, the spring sheet 153 and the protrusion structure 155 have no relative movement, and the two do not interfere with each other and will not affect the other first driving mechanism 130a.

[0144] When the two first driving mechanisms need to be linked, force is applied to the outer tube 152 and the driving ring 154. At this time, the friction plate 158 and the protrusion 160 rotate relative to each other, that is, the outer tube 152 and the driving ring 154 move relative to each other. The protruding structure 155 of the driving ring 154 acts on the spring sheet 153, so that the spring sheet 153 presses the buffer sleeve 156 inward until it is engaged with the inner tube 151. At this time, the two first driving mechanisms can be linked, that is, driving the first driving mechanism 130a or the first driving mechanism 130b can realize the simultaneous movement of the two operating arms.

[0145] refer to Fig.25It is a schematic diagram of a closure device in the prior art that uses sutures 401 to gather the suture area 411 on the tissue. Specifically, only two points can be sutured (one suture is used for each two points, and two points form a group. When there are multiple groups of suture points, there are corresponding numbers of sutures). When suturing a large diameter wound, multiple devices are required.

[0146] And reference Fig.26 This embodiment also discloses a tissue closing method, which is used to close the suture area 411 on the tissue by means of suture 401. When it is implemented, the closing devices of the above embodiments can be used. The suture is a single-line suture. The tissue closing method includes:

[0147] The suture 401 is threaded multiple times along the edge of the suture area 411 in a sinking and floating manner. Sinking and floating are relative to the tissue. Threading downward is sinking, and threading upward is floating. When the suture 401 is a dotted line, it sinks below the tissue. When the suture 401 is a solid line, it floats above the tissue. The operation of the closing device during each threading can be referred to above and will not be repeated here.

[0148] After the suture 401 is threaded, the two ends of the suture 401 are tightened and knotted to keep the suture area closed. After inserting a row of sutures at one time, the present invention can use a single device to suture a wound within a preset diameter range, and a tightening track is preset, so the docking effect is better.

[0149] In this embodiment, combined with the extension direction of the suture 401 relative to the suture area 411, a purse-string pre-embedded suture or the like can be used. This suturing method reduces the risk of the blade cutting the suture during puncture, that is, the probability of instrument failure, and is particularly suitable for large-caliber tissues.

[0150] The tissue closure method of the present application can continuously remove the needle and perform multi-point suturing. When all the sutures are buried around the tissue wound that needs to be sutured, the suture 401 is tightened, and the wound is tightened accordingly to complete the suturing, and the sealing performance is better.

[0151] The 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.

[0152] 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.

[0153] 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 closure device for tissue suturing, having opposite distal and proximal ends, characterized in that: The closure device comprises: A handle, configured with a driving mechanism; a catheter, the proximal end of which is fixed to the handle; Two operating arms are connected to the distal end of the catheter, each operating arm is controlled by the driving mechanism, and each operating arm is provided with a needle holding mechanism. The operating arm has a connecting end that cooperates with the catheter for rotation and a free end that swings around a rotation axis. During the relative swinging process, the free ends of the two operating arms are interactively used to guide the suture needles of the suture into the tissue through their respective needle holding mechanisms.

2. The closure device according to claim 1, characterized in that The catheter has a first axis extending at the distal end and the proximal end, the rotation axis of the operating arm is the second axis, and the angle between the second axis and the first axis is 45 to 90 degrees; the two operating arms swing around the same axis.

3. The closure device according to claim 1, characterized in that: The two operating arms have a first state in which the free ends are away from each other, and a second state in which the free ends are close to each other; An elastic member is provided between the two operating arms, or between the conduit and at least one operating arm, for acting on at least one operating arm to move toward the first state.

4. The closure device according to claim 3, characterized in that The elastic member is fixed to one of the operating arms and movably abuts against the other operating arm; or the two operating arms are respectively provided with the elastic member, and in the second state, the elastic members of the two operating arms approach and abut against each other.

5. The closure device according to claim 1, characterized in that: Two traction cables are configured for the same operating arm, the proximal end of each traction cable is connected to the corresponding driving mechanism, the distal end of each traction cable is connected to the operating arm, and the proximal end of each traction cable moves synchronously to drive the operating arm to switch states.

6. The closure device according to claim 5, characterized in that For the same operating arm, the distal ends of the traction cables are respectively fixed to the operating arm, or intersect with each other to form an integrated structure; The operating arm is provided with a receiving groove at a position adjacent to the connecting end, and at least a part of the traction rope is fixed in the receiving groove.

7. The closure device according to claim 1, characterized in that The binding force between the needle holding mechanism on each operating arm and the suture needle can be relatively changed during the interactive suture process; the binding force between the needle holding mechanism on at least one operating arm and the suture needle is actively adjusted.

8. The closure device according to claim 1, characterized in that The needle holding mechanism comprises: A needle slot is provided on the operating arm and is used to receive the end of the sewing needle; A movable pin is arranged in the catheter, the outer peripheral wall of the suture needle is provided with a coupling groove, the distal end of the movable pin matches with the coupling groove, and the proximal end of the movable pin is connected to the corresponding driving mechanism.

9. The closure device according to claim 8, characterized in that The movable pins on the two operating arms move synchronously to switch the matching state with the sewing needle; A pin hole is formed on the slot wall of the needle slot, and the distal end of the movable pin enters or withdraws from the needle slot via the pin hole.

10. A tissue closing method implemented by the closing device according to any one of claims 1 to 9, for closing a sutured area on a tissue by means of sutures, characterized in that: include: 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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