System for clamping tissue

Abstract

The present invention provides a system for clamping tissue, the system for clamping tissue being a fixation device including a clamping mechanism for closing tissue and a support mechanism for mounting the clamping mechanism, the support mechanism including a fixation device including a drive unit for driving the clamping mechanism to open and close, a push shaft for pushing the fixation device to a predetermined position, and a movement control device including a separation device for separably joining the push shaft and the fixation device, the clamping mechanism including a pair of closing members, the closing members being provided with a guide groove including at least one non-linear portion, the support mechanism being provided with a groove driving member at least a part of which is located within the guide groove, the groove driving member being reciprocatingly slidable within the guide groove, and being capable of driving the two closing clamping members to move closer to or farther apart. By improving the driving method, the stability and reliability of gripping the leaflets are improved.

Description

Technical Field

[0001] The present invention relates to medical devices, and particularly to a system for clamping tissue.

Background Art

[0002] With the progress of medical technology, traditional high-risk surgeries are being replaced by minimally invasive catheter surgeries. Currently, the minimally invasive intervention techniques mainly developed and applied in the market include indirect annuloplasty, direct annuloplasty, edge-to-edge repair, and chordae tendineae repair.

[0003] The edge-to-edge repair technology has gradually matured through clinical practice in treating mitral valve regurgitation in surgery and shows good treatment effects.

[0004] The valve clip device developed based on the principle of the edge-to-edge suture technology of the surgical valve membrane is currently the most affirmed because of its high safety, simple technical principle, and high feasibility.

[0005] In the prior art, when using a valve clip device system, the valve clip device needs to be moved to a predetermined position of the heart by a moving unit, and after being clamped and fixed by the valve clip device, the valve clip device needs to be left in the heart as an implant. On the other hand, the moving unit needs to be separated from the valve clip device by a separating device. However, in the prior art, since the clip needs to pass through a narrow passage and bend, there is a certain limit to the length of the clip, and furthermore, the grasping distance is limited. In the prior art, generally, the inversion angle of the clip is also limited by a link mechanism for driving the clip, and the difficulty of grasping the valve leaflet is improved. In short, there is room for improvement in its driving method and separating method.

Summary of the Invention

Problems to be Solved by the Invention

[0006] To solve the above problems, the present invention provides a system for clamping tissue that improves the stability and reliability of the grasping of the valve leaf by improving the driving method.

Means for Solving the Problems

[0007] Specifically, it includes the following aspects. A system for clamping tissue, A fixing device including a clamping mechanism for closing the tissue and a support mechanism for attaching the clamping mechanism, wherein the support mechanism includes a fixing device including a driving unit for driving the clamping mechanism to open and close, A push shaft for pushing the fixing device to a predetermined position, and a separation device movement control device for detachably joining the push shaft and the fixing device, The clamping mechanism includes a pair of closing members, the closing members are provided with a guide groove including at least one non-linear portion, the support mechanism is provided with a groove driving member at least a part of which is located in the guide groove, and the groove driving member is reciprocally slidable in the guide groove, thereby driving the two closing clamping portions to approach or separate relatively.

[0008] Furthermore, the clamping mechanism includes a pair of closing members and a pair of grasping members installed corresponding to each of the closing members, the closing members include a closing connection portion and a closing clamping portion, and the closing clamping portion is used to clamp the tissue in cooperation with the grasping members, The guide groove is provided in the closing connection portion.

[0009] Furthermore, the support mechanism includes a fixed connection unit, the fixed connection unit is provided with a groove driving member at least a part of which is located in the guide groove, the driving unit is connected to the two closing connection portions, and when the driving unit moves relative to the fixed connection unit, the groove driving member is configured to reciprocally slide in the guide groove.

[0010] Furthermore, the guide groove includes at least two communicating guide grooves, and the radian of the first guide groove is larger than that of the second guide groove.

[0011] Furthermore, it further includes a third guide groove communicating with the second guide groove and having a radian larger than that of the second guide groove, and the second guide groove is located between the first guide groove and the third guide groove.

[0012] Furthermore, the separation device includes an operating rod that is non-rotatable relative to the drive unit and is axially separably joined thereto, and the operating rod drives the axial movement of the drive unit by rotating. The operating rod is configured to disengage the separation device from the fixing device when moving to the proximal end as preset.

[0013] Furthermore, the support mechanism includes a fixed connection unit and a drive unit that is relatively movable with respect to the fixed connection unit, and the fixed connection unit includes a base separation end. The separation device includes a joint base separably joined to the base separation end, an engagement member connecting the base separation end and the joint base, and the operating rod capable of supplying a driving force to the drive unit. The operating rod includes an operating rod separation end that is axially separable and non-rotatably connected to the drive unit, and the operating rod is configured to be movable between a first position and a second position with respect to the engagement member, and when the operating rod moves to the proximal end at the second position, the operating rod support portion can relatively separate the joint base and the base separation end by simultaneously moving the engagement member to the proximal end.

[0014] Furthermore, the joint base includes a joint base connection end, a joint base separation end, and a joint base chamber penetrating through the joint base. The engaging member is provided in the joint base chamber. The joint base separation end is connected to the base separation end through the engaging member. The joint base connection end is used to be connected to a moving device.

[0015] Furthermore, the movement control device further includes an operation wire for controlling the opening and closing of the gripping member of the clamping mechanism. The Joint base includes an operation wire limiting groove. When the joint base is connected to the base separation end, the operation wire limiting groove restricts the detachment of the operation wire.

[0016] Furthermore, the fixed connection unit includes a base housing. A base chamber is provided in the base housing. A base screw portion is provided in the base chamber. The drive unit includes a drive shaft. The drive shaft includes a drive screw portion that engages with the base screw portion. The lead angle at which the base screw portion and the drive screw portion engage is smaller than the friction angle.

Advantages of the Invention

[0017] As described above, the present invention has the following beneficial effects. 1) By improving the driving method so as to use a guide groove having a non-linear portion for driving, the opening angle and the gripping distance of the closing member are improved. As a result, it becomes easier to grip the valve leaf, the valve leaf contact surface becomes longer, and it is possible to grip the valve leaf more firmly. 2) By sequentially providing the arc-shaped first guide groove, the linear second guide groove, and the arc-shaped third guide groove, when opening the closing member from the initial position and when at the maximum opening angle position, the required moment is smaller and the change speed is faster than in the intermediate gripping process. On the other hand, at the gripping portion, with a slow angle change, it facilitates the fine operation of the surgeon and enhances the reliability of the system. 3) In the process of separating the operating rod separation end and the transmission rod separation end, the joint base and the base separation end can also be separated simultaneously, eliminating the need to release the connection relationships of various components through multiple complex steps and enabling the entire separation operation to be completed in one step. 4) When stopping the base housing or the drive shaft, even if only an axial force is applied to the base housing or the drive shaft, they will not displace axially. Unlike the prior art, there is no need for self-locking by a leaf spring or other structures, and they can be stopped at any position by screw threading.

Brief Description of the Drawings

[0018] To more clearly illustrate the technical solution means of the present invention, the following briefly describes the drawings necessary for the description of the embodiments or the prior art. Obviously, the drawings in the following description are only some embodiments of the present invention, and those skilled in the art can also obtain other drawings based on these drawings without creative efforts.

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Mode for Carrying Out the Invention

[0019] The following will clearly and completely describe the technical solution of the embodiments of the present invention with reference to the drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, not all of the embodiments. In this embodiment, the "proximal end" described refers to the direction approaching the operator, and the "distal end" refers to the direction away from the operator. All other embodiments obtained by those skilled in the art without creative efforts based on the embodiments of the present invention belong to the patent scope of the present invention.

[0020] Example 1 In this example, a system for clamping tissue is provided. Specifically, this system is a fixing device including a clamping mechanism 1000 for closing the tissue and a support mechanism 2000 for attaching the clamping mechanism 1000, and the support mechanism 2000 is a fixing device including a drive unit 2200 for driving the opening and closing of the clamping mechanism 1000, a push shaft 600 for pushing the fixing device to a predetermined position, and a movement control device including a separation device 3000 for detachably joining the push shaft 600 and the fixing device. The clamping mechanism 1000 includes a pair of closing members 1100. The closing members 1100 are provided with guide grooves 1121 each including at least one non-linear portion. The support mechanism 2000 is provided with groove driving members 850 at least partially located within the guide grooves 1121. The groove driving members 850 are reciprocally slidable within the guide grooves 1121 and drive the two closing clamping portions 1110 to approach or separate relative to each other.

[0021] In this embodiment, specifically, the clamping mechanism 1000 includes a pair of closing members 1100 and a pair of gripping members 1200 installed corresponding to each closing member 1100. The closing members 1100 are opened and closed by a drive unit 2200, and the gripping members 1200 are opened and closed by an operating wire 610. When clamping tissue, clamping is achieved by a combination of the inward movement of the closing members 1100 and the outward movement of the gripping members 1200. In this embodiment, taking the clamping of a heart valve as an implementation scenario, the specific operating principle of the fixing device for clamping the tissue of the present application will be described. As shown in FIG. 1, the fixing device of the present application is moved to a predetermined position of the heart by a movement control unit. Specifically, the movement control unit includes a push shaft 600 for pushing the fixing device to a predetermined position and a separation device 3000 that detachably joins the push shaft 600 and the fixing device. In an embodiment of the present invention, the push shaft 600 is a rod-shaped or hollow tubular body having a chamber inside and is made of a biocompatible material. In this embodiment, the engaging shaft 820 is rod-shaped or tubular, and the surface of the push shaft 600 is smooth, thereby avoiding the push shaft 600 from damaging the valve leaflets or catching the chordae tendineae. Here, the push shaft 600 first enters the surgical passage together with the catheter 500. After reaching near the lesion, the push shaft 600 extends out of the catheter 500 and moves the fixing device to the mitral valve. The distal end of the fixing device, that is, the distal end of the clamping mechanism 1000, is preferably covered with a protective coating layer. The protective coating layer is made of a biocompatible material and completely covers the outer periphery of the clamping mechanism 1000, and can prevent the device from damaging the tissue. When the fixing device is left in the heart as an implant, the outer surface of the fixing device can be completely protected by the protective coating layer.

[0022] After the fixing device reaches the lesion position, due to the cooperation between the closing member 1100 and the gripping member 1200 of the clamping mechanism 1000 in this embodiment, the anterior leaflet and the posterior leaflet of the heart valve can be clamped at positions where they cannot be properly aligned, so that the positions of the parts that cannot be properly aligned are aligned, thereby completely closing the mitral valve or reducing the opening area, and treating or alleviating "mitral regurgitation".

[0023] After the clamping of the mitral valve is completed, the fixing device is separated from the movement control unit by the separating device 3000, whereby the fixing device is left in the lesion to maintain the fixation of the valve.

[0024] The guide groove 1121 includes at least two guide grooves, namely a first guide groove and a second guide groove that communicate with each other, and the radian of the first guide groove is larger than the radian of the second guide groove. Fig. 6(a) is a diagram showing an implementation form of the guide groove of the first embodiment of the present application. This guide groove is divided into a first guide groove, a second guide groove, and a third guide groove from the separated end to the proximate end. The first guide groove and the third guide groove are arc-shaped parts, and the second guide groove is a straight part. Here, the characteristics of the arc part are that there is a change in the inversion angle with a larger magnitude, but the moment is small, the moment changes non-linearly, and the change range is small, and there is a dead point where the moment is zero. On the other hand, the characteristics of the straight part are that the moment is large, the moment changes linearly and stably, the change range is large, there is no moment dead point, but the change in the inversion angle is small. Therefore, by sequentially providing the arc-shaped first guide groove, the straight second guide groove, and the arc-shaped third guide groove in the guide groove 1121, when opening the closing member at the initial position and when at the position of the maximum opening angle, the required moment is smaller and the change speed is faster than in the intermediate gripping process. On the other hand, in the gripping part, the angle change is slow, facilitating the fine operation of the surgeon and enhancing the reliability of the system.

[0025] As shown in FIGS. 6(a), 6(c), and 6(d), the groove driving member 850 is circular in cross-section and is located within the guide groove 1121, and the width of the guide groove 1121 matches the outer diameter of the groove driving member 850. When in the non-open initial position, the groove driving member 850 is at the closest end and is located at the closest end of the third guide groove as shown in FIG. 6(c). At this time, the distance between the groove driving member 850 and the closing member cooperation part 2320 is h1. During the process of the closing clamping part 1110 opening, the groove driving member 850 slides towards the separated end in the third guide groove and enters the second guide groove at the most separated end of the third guide groove. At this time, the angle by which the closing clamping part 1110 has rotated is α1. The groove driving member 850 further slides towards the separated end. When the groove driving member 850 is located at the most separated end of the second guide groove, i.e., the end of the straight part, the angle by which the closing clamping part 1110 has rotated is α2. At this time, the distance between the groove driving member 850 and the closing member cooperation part 2320 is h2 as shown in FIG. 6(d). When the groove driving member 850 further slides towards the separated end in the first guide groove and reaches the most separated end of the guide groove 1121, the angle by which the closing clamping part 1110 has rotated is α3. However, the ranges of the values of α1, α2, α3, h1, and h2 can all be selected based on actual needs. In this embodiment, preferably, the range of the value of α1 is 30° - 45°, more preferably 35° - 40°, and even more preferably 40°; the range of the value of α2 is 55° - 70°, more preferably 60° - 70°, and even more preferably 65°; the range of the value of α3 is 120° - 150°, more preferably 125° - 135°, and even more preferably 130°; the range of the value of h1 is preferably 15 - 16 mm, more preferably 15.5 mm; the distance of h2 is 5 - 7 mm, more preferably 6 mm. As can be understood from the above description, to rotate the closing clamping part 1110 by an angle of α2, it is necessary to drive the closing member cooperation part 2320 so that the groove driving member 850 moves by a distance of h2 - h1. When α2 is 65°, h1 is 15.5 mm, and h2 is 6 mm, that is, when the two closing clamping parts 1110 open towards each other by 130°, the moving distance of the closing member cooperation part 2320 is 9.5 mm.The combination of the arcuate first guide groove, the straight second guide groove, and the arcuate third guide groove causes the closing member to open at a faster rate of change when opening from the initial position and when at the maximum opening angle position than during the intermediate grasping process. In the grasping portion, the rate of change of the angle becomes slower, the grasping becomes more stable, and in the present application, the driving distance required to reach the preset grasping angle is smaller than in the case of a normal straight groove, and at positions where fine operation is required, it is safer and more reliable than in the case of a curved groove.

[0026] FIG. 6(b) is a diagram showing an implementation form of the guide groove 1121 of another embodiment of the present application. This guide groove 1121 is divided into a first guide groove and a second guide groove from the separated end toward the proximity end. The first guide groove is an arcuate portion, and the second guide groove is a straight portion. This is mainly the result of considering that when the grasping position reaches the maximum opening angle, it can quickly close, while when grasping the tissue, the straight portion reduces the rate of change of the angle in the grasping portion, thereby making the grasping more stable. Specifically, in this way, the change in the angle from the closest portion of the guide groove 1121 to the boundary between the first guide groove and the second guide groove is θ1, the change angle of the groove driving member 850 in the straight portion of the guide groove 1121 is θ1, and when further moving to the most separated end, the opening angle of one of the closing clamping portions 1110 is θ2. Preferably, the range of the value of θ1 is 40° to 60°, and the range of the value of θ2 is 120° to 140°.

[0027] As shown in FIGS. 3 and 8, the driving unit 2200 includes a moving base 2300. Specifically, it includes a driving connection block 2310. The side surface of the driving connection block 2310 includes a first mounting surface and a second mounting surface that are perpendicular to each other. The driving connection block 2310 is hinge-connected to the closing connection portion 1120 via a closing member cooperation portion 2320 provided on the first mounting surface, thereby driving the movement of the closing member cooperation portion 2320 and further realizing the relative movement between the guide groove 1121 and the groove driving member 850.

[0028] Furthermore, as shown in FIG. 7, in the present application, the gripping member 1200 includes a rigid gripping portion 1210, a flexible connection portion 1220, and a gripping connection portion 1230 that are connected in sequence. The flexible connection portion 1220 is located between the rigid gripping portion 1210 and the gripping connection portion 1230, and the second attachment surface is fixedly connected to the gripping connection portion 1230. In this embodiment, the gripping member cooperates with the closing member and is used to grip the movable valve leaf. The gripped valve leaf is located between the closing member and the gripping member. The gripping connection portion is used to be connected to the second attachment surface. The natural state of the gripping member presents the shape of an unfolded bird's wing. Here, the flexible connection portion is specifically a component that can be deformed but has a certain repulsive force. When an external reversing force is applied to the rigid gripping portion, the flexible connection portion elastically deforms, changes the angle between the rigid gripping portion and the axial direction, realizes the reversal of the gripping member. When the movable valve leaf to be gripped is located above the closing member on one side of the gripping member, if the external reversing force is removed, the elastic flexible connection portion instantaneously performs an operation to recover the shape in the natural state. At this time, the valve leaf is gripped between the closing member and the rigid gripping portion. During the gripping of the valve membrane, the rigid gripping portion is mainly used to fix the movable valve membrane, and its structure needs to have a certain rigidity, thereby avoiding the gripped valve leaf from pushing away the gripping member and escaping.

[0029] More preferably, the rigid gripping portion 1210 includes a rigid surface 1211 and a gripping protrusion 1212 provided outside the rigid surface. The rigid surface 1211 has a uniform thickness and is formed in a curved shape. The rigid surface 1211 has the characteristics of a rigid cross-section, and its cross-sectional shape is curved as shown in FIG. 7(b) or bent as shown in FIG. 7(c). In this structure, due to the curved or bent portion, similar to adding a reinforcing rib to the main body, the cross-section of the sheet-shaped thin wall has a high flexural section modulus, and there is no need to further add a layer of components to increase the stiffness, which increases the stiffness of the rigid gripping portion. Also, in this embodiment, by pushing and pulling the operating wire in the movement control unit, a force is applied to the gripping member with the wire guide hole 1213 through the operating wire to realize the reversal operation of the gripping member.

[0030] In this embodiment, the two gripping members 1200 share one gripping connection portion 1230. The gripping connection portion 1230 is U-shaped, and its symmetrical vertical portions are fixedly connected to the symmetrically arranged second mounting surfaces of the drive connection blocks 2310 respectively. The gripping connection portion 1230 can be fixedly connected to the drive connection block 2310 by hinge connection, rivet connection or welding, etc. Thereby, the gripping member 1200 can operate axially together with the drive connection block 2310. Taking the groove drive member 850 as a reference point, when the drive connection block 2310 approaches axially in the direction of the groove drive member 850, the closing member 1100 performs a deployment and inversion operation, and the entire gripping member 1200 also performs an axial movement approaching in the direction of the groove drive member 850. At the same time, when an inversion external force in the direction of the groove drive member 850 is applied to the rigid gripping portion of the gripping member 1200, the gripping member 1200 inverses in the direction of the groove drive member 850. When it contacts the closing member 1100 with appropriate valve leaves deployed, the inversion external force on the gripping member 1200 is removed, and the valve leaves are clamped between the closing member 1100 and the gripping member 1200. In one embodiment, the natural state of the gripping member 1200 is an open state. The operating wire 610 is used to restrain the gripping member 1200 in a constricted state, and by removing the restraining force of the operating wire 610, the inversion of the gripping member 1200 can be realized. In another embodiment, the gripping member 1200 may be a flexible member, and the inversion gripping is realized directly by pushing the operating wire 610.

[0031] Furthermore, when the drive connection block 2310 begins to move axially away from the groove drive member 850, the closing member 1100 causes the gripping member 1200, which is deployed together with the gripped valve leaf, to perform a closing reverse operation. At the same time, the drive connection block 2310 moves axially in a direction away from the groove drive member 850 together with the entire gripping member 1200. At this time, the gripping member 1200 is displaced relative to the valve leaf or tends to be displaced relative to the valve leaf. The pressure generated due to the elastic deformation of the gripping member 1200 is applied to the valve leaf, and a frictional force is generated at the contact surface between the displaced gripping member 1200 and the valve leaf. The direction of the frictional force applied from the gripping member 1200 to the valve leaf is the direction toward the drive connection block 2310. As a result, the gripping member has an operating characteristic of "pulling" on the valve leaf. By adding several friction increasing elements or protruding elements, such as the gripping protrusion 1212 in this embodiment, to the rigid gripping portion of the gripping member 1200, the effect of "pulling" the valve leaf becomes remarkable. In the present invention, compared with the proximal element that only performs the reverse operation of the background art, the connection between the valve leaf and the fixing device is made stronger.

[0032] Furthermore, in this embodiment, as shown in FIG. 3, the closing and clamping portion 1110 includes a free end and a connection end connected to the closing connection portion 1120. The outer surface of the closing and clamping portion 1110 tends to contract inward at least partially in the direction from the connection end to the free end. The closing and clamping portion 1110 has the characteristics of the mouth of a cup, and due to its characteristic structure with a concave inner side, when clamping the valve membrane, the contact area with the valve leaf can be increased. When cooperating with the gripping member 1200 to clamp and fix the valve membrane, by clamping the valve membrane in the recess of the mouth of the cup, the radial displacement of the fixing device at the valve leaf can be restricted. The characteristic structure of the flange of the closing and clamping portion 1110 avoids damage to the valve membrane by the edge of the closing and clamping portion 1110. After the fixing device finally closes the valve leaf, due to the characteristic structure in which the inner side of the closing and clamping portion 1110 is bent, a constriction is formed at the ends of the closing and clamping portions on both sides, thereby locking the valve leaf more firmly in the axial direction. Also, the clamping mechanism 1000 of other embodiments of the present invention is also used to relieve or treat "tricuspid regurgitation". That is, in order to treat "tricuspid regurgitation", in addition to the conventional pair of closing members 1100 and gripping members 1200, one more is added. Its principle and structure are the same as the principle and structure for solving mitral regurgitation in the embodiments of the present invention, and will not be described in detail here. As can be understood, other embodiments of the present invention can be used in other minimally invasive surgical procedures that need to clamp a plurality of leaf-shaped tissues, and the number of the closing members 1100 and the gripping members 1200 varies according to actual usage needs.

[0033] In this embodiment, the separation device 3000 includes an operating rod 3100 that is non-rotatably and axially separably joined to the drive unit 2200. The operating rod 3100 drives the axial movement of the drive unit 2200 by rotating, and the operating rod 3100 is configured to disengage the separation device 3000 from the fixing device when moving to the proximal end as preset. Hereinafter, with specific reference to FIGS. 3, 8, and 10, the separation principle of the separation device 3000 and the support mechanism 2000 will be explained.

[0034] Here, the support mechanism 2000 for attaching the clamping mechanism 1000 includes a fixed connection unit 2100 and a drive unit 2200 that is relatively movable with respect to the fixed connection unit 2100. Here, specifically, the drive unit 2200 includes a drive shaft 2230. The drive shaft 2230 includes a drive screw portion 2231 that engages with a base screw portion 2131. By having a rotational movement between the drive output shaft 2210 and the base housing, the axial movement of the drive shaft 2230 is realized. The rotation of the drive output shaft is realized by applying a rotational moment via an operation rod 3100 in the separation device 3000. Specifically, the operation rod 3100 includes an operation rod separation end 3120 that is axially separable from and non-rotatable relative to the drive unit 2200, and an operation rod support portion 3130. Specifically, the drive unit 2200 includes a transmission rod separation end 2220. The operation rod separation end 3120 is non-rotatably connected to the transmission rod separation end 2220. When the tension between the operation rod separation end 3120 and the transmission rod separation end 2220 is greater than a preset value, the operation rod separation end 3120 disengages from the transmission rod separation end 2220. Here, since the spiral angle of the spiral ring groove is smaller than the friction angle between the contact surfaces of the two spiral grooves, when the base housing or the drive shaft 2230 is stopped, even if only an axial force is applied to the base housing or the drive shaft 2230, they do not displace axially. Therefore, when it is necessary to separate the operation rod separation end 3120 and the transmission rod separation end 2220, if the operation rod 3100 is pulled axially toward the proximal end while the separation end of the transmission rod separation end 2220 remains stationary, it can be disengaged when the preset value is reached.

[0035] Specifically, in this embodiment, the specific realization structure for disengaging when the preset value is reached is as follows.

[0036] A deformable clip 3121 is provided on one of the operation rod separation end 3120 and the transmission rod separation end 2220. The deformable clip 3121 may be made of an elastic biocompatible material, for example, some biocompatible polymer materials. A separation and joining groove 2222 is provided on the other. An engaging shaft 820 that can be fitted and connected with the deformable clip 3121 is provided in the separation and joining groove 2222. The engaging shaft 820 is inserted into the coupling shaft hole 222. Specifically, the deformable clip 3121 has an engaging port 3122 and an engaging hole 3123 that matches the engaging shaft 820 after passing through the engaging port 3122. The operation rod separation end 3120 and the transmission rod separation end 2220 are connected via the deformable clip 3121 and the engaging shaft 820. When the tension between the operation rod separation end 3120 and the transmission rod separation end 2220 is greater than a preset value, the deformable clip 3121 disengages from the engaging shaft 820. In this embodiment, the deformable clip 3121 is installed at the operation rod separation end 3120, and the separation and joining groove 2222 is installed at the transmission rod separation end 2220. It may be installed conversely.

[0037] In the process of separating the operation rod separation end 3120 and the transmission rod separation end 2220, in order to separate the outer housing of the support mechanism 2000 from the outer housing of the separation device 3000, specifically, in this embodiment, the separation device 3000 is further provided with a joint base 3300 that is separably joined to the base separation end 2120, and an engaging member 3200 that connects the base separation end 2120 and the joint base 3300. The operation rod 3100 is configured to be movable between a first position and a second position with respect to the engaging member 3200. When the operation rod 3100 moves to the proximal end at the second position, the operation rod support portion 3130 can simultaneously move the engaging member 3200 to the proximal end, thereby making the joint base 3300 and the base separation end 2120 relatively separable, and thereby realizing that the joint base 3300 and the base separation end 2120 can be separated simultaneously in the process of separating the operation rod separation end 3120 and the transmission rod separation end 2220. Specifically, in this embodiment, the joint base 3300 includes a joint base connection end 3310, a joint base separation end 3320, and a joint base chamber 3330 that penetrates the joint base 3300. The engaging member 3200 is provided in the joint base chamber 3330. The joint base separation end 3320 is connected to the base separation end 2120 via the engaging member 3200. The joint base connection end 3310 is used to be connected to the moving device.

[0038] The body of the base separation end 2120 is an extension of the tubular structure of the base. The joint base separation end 3320 may be externally fitted to the base separation end 2120 or inserted into the base separation end 2120. The contact surfaces of the two separation ends are respectively called the base fitting surface and the joint base fitting surface. Here, a base engaging hole 2121 is provided in the radial direction of the base fitting surface, and a joint base engaging hole 3321 in the same direction is provided in the radial direction of the corresponding joint base fitting surface. The joint base engaging hole 3321 is provided in the joint base separation end 3320, and a base engaging hole 2121 corresponding to the joint base engaging hole 3321 is provided in the base separation end 2120. The engaging member 3200 includes a clip 3220 that relatively fixes the joint base 3300 and the base separation end 2120 by simultaneously penetrating the joint base engaging hole 3321 and the base engaging hole 2121. The clip 3220 is configured such that when the engaging member 3200 moves toward the proximal end with respect to the joint base 3300, the clip 3220 disengages from the joint base engaging hole 3321 and / or the base engaging hole 2121, so that the joint base 3300 and the base separation end 2120 can be relatively separated.

[0039] Clip 3220 is made of a flexible material. When the engaging member 3200 moves towards the proximal end with respect to the joint base 3300, the clip 3320 deforms. As a result, the clip can directly disengage from the joint base engaging hole 3321 and the base engaging hole 2121 and cannot recover and effectively separate. The material of the clip 3220 is made of a biocompatible plastic or metal that does not recover after being bent.

[0040] Furthermore, in this embodiment, the engaging member 3200 further includes an engaging claw bottom ring 3230 and an engaging claw connecting rod 3210 that has the same number as the clips 3220 and connects the clips 3220 and the engaging claw bottom ring 3230. A bottom ring hole is provided in the engaging claw bottom ring 3230. The number of the engaging claw connecting rods 3210 is from 3 to 6 and is uniformly distributed and connected to the side surface of the engaging claw bottom ring 3230. Preferably, the number of the engaging claw connecting rods 3210 is 3. Here, the radial surface of the shaft-shaped or rod-shaped operation rod support portion 3130 restricts the movement of the clip 3220 towards the center, restricts the clip 3220 from accidentally slipping out of the base engaging hole 2121 and the joint base engaging hole 3321, and can further maintain the connection between the base separation end 2120 and the joint base 3300. The operation rod 3100 further includes an operation rod connection end 3110 connected to the proximal end of the operation rod support portion 3130. The proximal end of the operation rod connection end 3110 is connected to the drive source after passing through the bottom ring hole. The outer diameter of the proximal end of the operation rod support portion 3130 is larger than the inner diameter of the bottom ring hole.

[0041] The length of the operation rod support portion 3130 is smaller than the length of the engagement claw connection rod 3210, and the outer diameter of the operation rod support portion 3130 is configured such that when the operation rod support portion 3130 is positioned in the joint base engagement hole 3321, the outer surface of the operation rod support portion 3130 prevents the clip 3220 from detaching from the joint base engagement hole 3321 and the base engagement hole 2121. Therefore, when the operation rod support portion 3130 contacts the engagement claw bottom ring 3230 and further moves toward the proximal end, the clip 3220 deforms.

[0042] Based on the above structure, when attempting to separate the base separation end 2120 and the joint base 3300, the operation rod moves in the direction of the engagement claw bottom ring 3230 under the action of an axial force. At the same time, the engagement claw bottom ring 3230 is pressed by the operation rod, and the operation rod support portion 3130 disengages from the clip 3220, and its radial movement is no longer restricted. Under the condition of sufficient external force, the clip 3220 can be pulled out from the base engagement hole 2121 and the joint base engagement hole 3321, thereby realizing the separation of the base separation end 2120 and the joint base 3300.

[0043] To further explain the above embodiment, the joint base separation end 3320 is externally fitted to the base separation end 2120. As shown in FIG. 11, Joint base 3300 includes an operation wire limiting groove 3322. There is an expansion portion at the head of the operation wire 610 for opening and closing the gripping member 1200 of the clamping mechanism 1000 in the movement control unit. This expansion portion is disposed within the base end hole 2122, and its minimum dimension is larger than the operation wire limiting groove 3322 and smaller than the base end hole 2122. When the joint base 3300 is connected to the base separation end 2120, the operation wire limiting groove 3322 restricts the detachment of the operation wire 610. In one embodiment, a channel that penetrates and communicates from the proximal end to the operation rod separation end 3120 is provided within the operation rod 3100. Since there is no need to make the operation rod solid and connect it with screws as in the prior art, in this application, in order to fit into the deformable clip 3121 through the separation joint groove 2222, the inside of the operation rod is made hollow, and a soft shaft for controlling the direction can be installed, thereby saving the external operation structure for controlling bending.

[0044] Then, with reference to FIGS. 3 and 8, the structure and principle of the support mechanism 2000 will be described. The support mechanism 2000 includes a fixed connection unit 2100 and a drive unit 2200 that is relatively movable with respect to the fixed connection unit 2100. When the separation end of the drive unit 2200 is connected to the two closing members 1100, the opening and closing of the closing members 1100 are controlled when the drive unit 2200 moves with respect to the fixed connection unit 2100. Specifically, the closing member 1100 of the clamping mechanism 1000 includes a closing connection portion 1120 and a closing clamping portion 1110. The closing clamping portion 1110 is used in cooperation with the gripping member 1200 to clamp tissue. A guide groove 1121 is provided in the closing connection portion 1120. The fixed connection unit 2100 is provided with a groove drive member 850 at least a part of which is located within the non-linear guide groove 1121. The guide groove 1121 includes at least a part of a non-linear portion. The drive unit 2200 is connected to the two closing connection portions 1120, and when the drive unit 2200 moves with respect to the fixed connection unit 2100, the groove drive member 850 reciprocally slides within the guide groove 1121 to drive the two closing clamping portions 1110 to approach or separate relatively.

[0045] Furthermore, the base housing further includes a base support ear 2110 provided at the separation end, and the groove drive member 850 is provided outside the base support ear 2110. By controlling the drive unit 2200 to move with respect to the groove drive member 850, the opening and closing of the closing member 1100 are controlled.

[0046] Specifically, the fixed connection unit 2100 includes a base housing, a base chamber 2130 is provided in the base housing, a base screw portion 2131 is provided in the base chamber 2130, the drive unit 2200 includes a drive shaft 2230, and the drive shaft 2230 includes a drive screw portion 2231 that is screwed with the base screw portion 2131. The lead angle at which the base screw portion 2131 and the drive screw portion 2231 are screwed together is smaller than the friction angle.

[0047] In this embodiment, after the drive screw portion 2231 and the base screw portion 2131 are screwed together, since they have the same pitch and cross-sectional shape, by rotating the base housing or the drive shaft 2230, the relative axial movement between the base housing and the drive shaft 2230 can be realized. Since the helix angle of the spiral ring groove is smaller than the friction angle between the two spiral groove contact surfaces, when the base housing or the drive shaft 2230 is stopped, even if only an axial force is applied to the base housing or the drive shaft 2230, they will not displace axially. Thus, without realizing self-locking by a leaf spring or other structures as in the prior art, the self-locking function is realized, and it can stop at any position by screwing.

[0048] The drive unit 2200 further includes a drive output shaft 2210 provided at the separated end of the drive shaft 2230, and the outer diameter of the drive output shaft 2210 is smaller than that of the drive shaft 2230. The drive connection block 2310 is provided with a connection guide hole 2311 whose inner diameter matches that of the drive output shaft 2210, and the drive output shaft 2210 is rotationally fitted with the connection guide hole 2311 in the axial direction. The drive unit 2200 further includes a positioning sleeve 810 provided on the separated end side of the drive connection block 2310. After passing through the connection guide hole 2311, the drive output shaft 2210 is inserted into the positioning sleeve mounting hole 811 of the positioning sleeve 810 and fixedly connected to the positioning sleeve 810.

[0049] As can be seen from the description of the above structure, in this embodiment, an operation fitting method between the drive output shaft 2210 and the drive connection block 2310 is disclosed. The output end of the drive output shaft 2210 outputs thrust and tension to the drive connection block 2310 to realize the axial movement of the drive connection block 2310. However, since the drive output shaft 2210 and the base housing rotate, and the drive connection block 2310 and the base housing do not rotate and displace, by adopting the above structure, the rotation drive process can be realized without rotating the clamping mechanism, and the clamping mechanism operates stably in the axial direction. The positioning sleeve 810 may be a tubular member, and the axial end faces on both sides are the end faces of the positioning sleeve 810. The fixed connection between the positioning sleeve 810 and the output end of the drive output shaft 2210 may adopt a welding or interference fitting method, or a mechanical connection method. One mechanical connection method is disclosed below. A positioning sleeve positioning hole 812 is installed in the radial direction of the positioning sleeve 810, and a drive output shaft positioning hole 2211 is installed in the radial direction of the fitting portion between the output end of the drive output shaft 2210 and the positioning sleeve 810. A pin shaft 840 is inserted into the positioning sleeve positioning hole 812 and the drive output shaft positioning hole 2211.

[0050] Regarding the clamping mechanism 1000, referring to FIGS. 4 to 9 and FIGS. 12 to 13, in this embodiment, specifically, the separated end of the closed connection part 1120 is rotatably connected to the drive unit 2200. Specifically, it is rotatably connected to the separated end of the drive unit 2200. In this embodiment, a connection part shaft hole 1122 is provided in the closed connection part 1120 and is connected to the drive unit 2200 via a rotating shaft. In other embodiments, other hinge connection methods may be selected. Before the fixing device is moved to a predetermined position, the closed clamping part 1110 is located at the initial position, in the state of FIG. 12(a). The groove drive member 850 is located at the proximal end of the guide groove 1121. At this time, the closed clamping part 1110 is in the closed state. Under the drive of the drive unit 2200, since the groove drive member 850 and the guide groove 1121 are engaged, when the rotatable connection point between the drive unit 2200 and the closed connection part 1120 moves to the proximal end, that is, when the connection part shaft hole 1122 moves to the proximal end, the guide groove 1121 tends to move to the proximal end synchronously therewith. Since the groove drive member 850 does not operate, that is, the groove drive member 850 moves away from the proximal end with respect to the guide groove 1121, the closed clamping part 1110 changes to adapt to this distance. The groove drive member 850 appropriately rotates the groove 1121 with respect to the connection part shaft hole 1122, and further realizes the rotation of the closed clamping part 1110 with the connection part shaft hole 1122 as the center. The closed clamping part 1110 reverses outward with the connection part shaft hole 1122 as the axis, thereby reaching the states of FIGS. 12(b) and (c). Further driving the connection part shaft hole 1122 to move to the proximal end, the closed clamping part 1110 can reach the state of FIG. 12(d). At this time, the two closed clamping parts 1110 face each other to form a clamping angle of 180°, and the distance between the ends reaches the maximum clamping distance.

[0051] Due to the design of the guide groove 1121, after the two closed clamping parts 1110 form an included angle of 180° facing each other and then further reverse, they can open to form an obtuse angle as shown in Fig. 13(a) facing each other. It can be applied when it is necessary to withdraw the fixing device from the heart due to inaccurate positioning or other problems. Since the two closed clamping parts 1110 face each other to form an obtuse angle, during withdrawal, it tends to incline outward with the tissue contact surface, and without hooking on the tissue, the withdrawal process is smooth and safe. Specifically, the principle of the process in which the closed clamping part 1110 realizes the above opening angle by the cooperation of the groove driving member 850 and the guide groove 1121 will be described in detail later.

[0052] In this embodiment, the opening and closing process of the closed clamping part 1110 operates on the groove driving member 850 through the driving unit 2200. Since the groove driving member 850 and the fixed connection unit 2100 connected thereto do not operate, during the process of the closed clamping part 1110 of the closing member 1100 moving from the initial position to the open position, the closed connection part 1120 at its separated end moves towards the proximal end. Compared with the fact that the clamping element in the prior art can only perform a deployment and reverse operation, in the present invention, at this time, due to the two composite operations of the closing member 1100, the closing member 1100 can obtain a wider deployment distance in the radial direction. When it is in the initial position, there is no additional other mechanism for the closed connection part 1120, so the height of the entire fixing device is reduced, making it easier to bend during movement. Based on this, the length of the closing member 1100 can be made longer, thereby having a larger grasping distance.

[0053] After the closed clamping part 1110 cooperates with the grasping member 1200 to clamp the tissue, the closed clamping part 1110 needs to be further tightened. During the tightening process, since the closed connection part 1120 at its separated end moves towards the separated end, the closed clamping part 1110 has an effect of pulling towards the separated end. Based on the premise that the closing process has an "occluding" operating characteristic and the clamping of the tissue is firm, the valve leaf in the closed clamping part 1110 obtains a "pulling" effect, making the contact between the valve leaf and the closed clamping part 1110 stronger.

[0054] To specifically describe the specific application of the device in this embodiment during surgery, hereinafter, with reference to the structure specifically described in this embodiment, taking the repair process of the mitral valve as an example, the operation method of the system for clamping the tissue of the present application will be described.

[0055] First step: Use the push shaft 600 to push the fixing device connected thereto from the left atrium, pass through the mitral valve, and reach the left ventricle. At this time, the closing member 1100 of the clamping mechanism 1000 is in a constricted state as shown in Fig. 12(a).

[0056] Second step: By adjusting the relative position between the valve fixing device and the mitral valve with the push shaft 600, the two closing members 1100 of the fixing device are respectively brought close to the anterior leaf and the posterior leaf of the mitral valve, and then rotate the drive shaft 2230. When the base screw part 2131 is screwed with the drive screw part 2231, the drive connection block 2310 is moved to the separated end. With the groove drive member 850 as the reference point, when the drive connection block 2310 approaches axially in the direction of the groove drive member 850, the closing member 1100 performs a deployment inversion operation, thereby reaching the states shown in Figs. 12(b) and (c), and the closing member can be further inverted to the state shown in Fig. 12(d). At this time, the ends of the two closing members 1100 have the maximum distance, and the two closing clamping parts 1110 form an included angle of 180° facing each other. After further inversion, they can be opened to form an obtuse angle facing each other as shown in Fig. 13(a). This can be applied when it is necessary to withdraw the fixing device from the heart due to inaccurate positioning or other problems. Since the two closing clamping parts 1110 form an obtuse angle facing each other, during withdrawal, the tissue contact surface tends to tilt outwards, and the tissue will not be caught, and the withdrawal process is smooth and safe.

[0057] Third step: After the two closing members 1100 hold the valve leaf, control the operation wire 610 to invert the clamping member 1200 in the direction of the closing clamping part 1110, and the valve leaf is clamped between the closing member 1100 and the clamping member 1200 as shown in Fig. 13(b).

[0058] Fourth step: When the drive connection block 2310 starts to move axially away from the direction of the groove drive member 850, the closing member 1100 performs a closing reverse operation on the grasped valve leaf and the deployed grasping member 1200. At the same time, the drive connection block 2310 axially operates the entire grasping member 1200 away from the direction of the groove drive member 850, reaching the states shown in FIGS. 13(c) and (d). At this time, the grasping member 1200 is displaced relative to the valve leaf or tends to be displaced relative to the valve leaf. The pressure generated due to the elastic deformation of the grasping member 1200 is applied to the valve leaf, and a frictional force is generated on the contact surface between the relatively displaced grasping member 1200 and the valve leaf. The direction of the frictional force of the valve leaf applied by the grasping member 1200 is the direction towards the drive connection block 2310. Thereby, the grasping seat has an operating characteristic of "pulling" on the valve leaf.

[0059] The heart valve is repaired by a system for clamping the tissue of the present application. The closing clamping portion has an effect of pulling towards the separated end, so that the closing process has an operating characteristic of "biting", on the premise that the clamping of the tissue is firm. The valve leaf in the closing clamping portion obtains a "pulling" effect. By using a guide groove with a non-linear portion for driving, the opening angle and the grasping distance of the closing member are increased, making it easier to grasp the valve leaf, making the valve leaf contact surface longer, and making the grasped valve leaf stronger.

[0060] In this specification, the orientation terms such as before, after, above, and below are defined based on the positions of the components in the drawings and the positions of the components relative to each other, and are only for making the technical solution clear and easy to understand. It should be noted that the use of the above orientation terms should not limit the scope claimed by the present application.

[0061] When there is no contradiction, the above embodiments and the features of the embodiments in this specification can be combined with each other.

[0062] The above disclosure is only a preferred embodiment of the present invention. Of course, it cannot limit the scope of the claims of the present invention. Therefore, equivalent changes according to the claims of the present invention still belong to the scope covered by the present invention.

Claims

1. A system for clamping tissue, comprising: A fixing device including a clamping mechanism (1000) for closing the tissue and a support mechanism (2000) for attaching the clamping mechanism (1000), wherein the support mechanism (2000) includes a fixed connection unit (2100) and a drive unit (2200) that is relatively movable with respect to the fixed connection unit (2100) and drives the clamping mechanism (1000) to open and close; A movement control device including a push shaft (600) for pushing the fixing device to a predetermined position and a separation device (3000) for detachably joining the push shaft (600) and the fixing device; The clamping mechanism (1000) includes a pair of closing members (1100), the closing members (1100) include a closing connection part (1120) and a closing clamping part (1110), a guide groove (1121) including at least one non-linear part is provided in the closing connection part (1120), and a groove driving member (850) at least a part of which is located in the guide groove (1121) is provided in the fixed connection unit (2100); The fixed connection unit (2100) includes a base housing, a base chamber (2130) is provided in the base housing, and a base screw part (2131) is provided in the base chamber (2130); The drive unit (2200) includes a drive screw part (2231) screwed with the base screw part (2131), thereby including a drive shaft (2230) that is rotatable and axially relatively movable with respect to the fixed connection unit (2100), and a drive connection block (2310) connected to the two closing connection parts (1120); When the drive shaft (2230) rotates with respect to the fixed connection unit (2100) and axially moves relatively, the drive unit (2200) causes the drive connection block (2310) to move relative to the groove driving member (850), and the guide groove (1121) slides relative to the groove driving member (850), thereby driving the two closing clamping parts (1110) to relatively approach or separate, and enabling the two closing clamping parts (1110) to open at an angle greater than 180° with respect to each other; The lead angle at which the base screw part (2131) and the drive screw part (2231) are screwed together is smaller than the friction angle. A system for clamping tissue, characterized by the above.

2. The clamping mechanism (1000) includes a pair of closing members (1100) and a pair of gripping members (1200) installed corresponding to each of the closing members (1100). The closing clamping part (1110) is used to clamp tissue in cooperation with the gripping members (1200). The system for clamping tissue according to claim 1, characterized by the above.

3. The guide groove (1121) includes at least a first guide groove and a second guide groove that communicate with each other, and the radian of the first guide groove is larger than the radian of the second guide groove. The system for clamping tissue according to claim 1 or 2, characterized by the above.

4. The system for clamping tissue according to claim 3, characterized by including a third guide groove that communicates with the second guide groove and has a radian larger than the radian of the second guide groove, and the second guide groove is located between the first guide groove and the third guide groove.

5. The separating device (3000) includes an operating rod (3100) that is non-rotatable relative to the driving unit (2200) and is detachably joined in the axial direction. The operating rod (3100) drives the axial movement of the driving unit (2200) by rotating. The system for clamping tissue according to claim 1, characterized in that when the operating rod (3100) moves to the proximal end as preset, the separating device (3000) is configured to be detached from the fixing device.

6. The supporting mechanism (2000) includes a fixed connection unit (2100) and a driving unit (2200) that is movable relative to the fixed connection unit (2100). The fixed connection unit (2100) includes a base separation end (2120). The separating device (3000) includes a joint base (3300) that is detachably joined to the base separation end (2120), an engaging member (3200) that connects the base separation end (2120) and the joint base (3300), and an operating rod (3100) that can supply a driving force to the driving unit (2200). The operation rod (3100) includes an operation rod separation end (3120) that is axially separable and non-rotatable relative to the drive unit (2200), and an operation rod support portion (3130). The operation rod (3100) is configured to be movable between a first position and a second position with respect to the engagement member (3200). When the operation rod (3100) moves to the proximal end at the second position, the operation rod support portion (3130) simultaneously moves the engagement member (3200) to the proximal end, making the joint base (3300) and the base separation end (2120) relatively separable. A system for clamping tissue according to claim 5, characterized in that.

7. The joint base (3300) includes a joint base connection end (3310), a joint base separation end (3320), and a joint base chamber (3330) that penetrates the joint base (3300). The engagement member (3200) is provided in the joint base chamber (3330). The joint base separation end (3320) is connected to the base separation end (2120) via the engagement member (3200). The joint base connection end (3310) is used for connection to a moving device. A system for clamping tissue according to claim 6, characterized in that.

8. The movement control device further includes an operation wire (610) for controlling the opening and closing of the gripping member (1200) of the clamping mechanism (1000). The joint base (3300) includes an operation wire limiting groove (3322). When the joint base (3300) is connected to the base separation end (2120), the operation wire limiting groove (3322) restricts the detachment of the operation wire (610). A system for clamping tissue according to claim 7, characterized in that.

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