WO2022142259A1

WO2022142259A1 - Tissue fixation device with self-locking function

Info

Publication number: WO2022142259A1
Application number: PCT/CN2021/105802
Authority: WO
Inventors: 王凯; 陈剑锋; 张一�
Original assignee: 沛嘉医疗科技(苏州)有限公司
Priority date: 2020-12-30
Filing date: 2021-07-12
Publication date: 2022-07-07
Also published as: CN114680955A

Abstract

A tissue fixation device with a self-locking function, the device comprising a holding mechanism (1000) and a supporting mechanism (2000), wherein the holding mechanism (1000) comprises a pair of closure members (1100) and a capturing member (1200) arranged corresponding to each closure member (1100); the supporting mechanism (2000) comprises a fixed connection assembly (2100) and a driving assembly (2200); the driving assembly (2200) controls the closure members (1100) to open or close; the fixed connection assembly (2100) comprises a base housing, in which a base inner cavity (2130) having a base threaded portion (2131) is provided; the driving assembly (2200) comprises a driving shaft (2230); and the driving shaft (2230) comprises a driving threaded portion (2231) cooperated with the base threaded portion (2131), a lead angle of the base threaded portion (2131) cooperated with the driving threaded portion (2231) being smaller than a frictional angle. By means of the cooperation of the base threaded portion (2131) and the driving threaded portion (2231), when the base housing or the driving shaft (2230) is stopped, if an axial force is only applied to the base housing or the driving shaft (2230), the base housing or the driving shaft will not be axially displaced.

Description

A tissue fixation device with self-locking function

technical field

The present invention relates to medical instruments, in particular to a tissue fixing device with self-locking function.

Background technique

The most common treatments for mitral valve regurgitation rely on prosthetic valve replacement, as well as valvuloplasty, such as rectangular posterior leaflet excision, chordae folds, edge-to-edge (edge-to-edge) repair techniques, prosthetic chordae implantation techniques , Replacement and Repair These techniques typically rely on open-heart surgery, in which the patient's chest is opened, usually through a sternotomy, and the patient is placed on a cardiopulmonary bypass.

With the advancement of medical technology, minimally invasive catheter surgery is gradually replacing traditional high-risk surgical procedures. The minimally invasive interventional techniques currently carried out and applied in the market include: indirect annuloplasty, direct annuloplasty, edge-to-edge repair, and chordae tendineae repair.

Edge-to-edge repair technology has gradually matured in the clinical practice of surgical treatment of mitral regurgitation, and has shown good therapeutic effects.

The valve clamp instrument developed according to the principle of surgical valve edge-to-edge suture technology is currently the most recognized because of its high safety, simple technical principle and great feasibility.

In the prior art, in order to prevent the clamping mechanism from opening in advance before reaching the predetermined position, a corresponding locking mechanism needs to be provided. For example, an elastic sheet can be used for initial locking. The screw groove is used to fix the position of the pull rod and then lock the opening and closing of the distal element. When the distal element needs to be opened and closed, an external force must be used to compress the elastic body to release the stuck part. The disadvantage of this structure is that the locking force depends on the elastic force of the elastic body. If the elastic force is too small, the locking force will be insufficient, and if the elastic force is too large, the external force required for unlocking will be increased.

SUMMARY OF THE INVENTION

In order to solve the above technical problems, the present invention provides a tissue fixation device with a self-locking function. The helix angle of the helical ring groove is smaller than the friction angle between the contact surfaces of the two helical grooves. If only an axial force is applied to the base housing or the drive shaft, there will be no axial displacement. Thereby, the self-locking function is realized, and the self-locking function does not need to be realized by means of spring sheets or other structures as in the prior art, and it can stay at any position through screw fitting.

Specifically, it includes the following solutions:

A tissue fixation device with self-locking function, comprising:

A clamping mechanism for closing tissue, comprising a pair of closure members and a catch member corresponding to each closure member for cooperating with the closure members to clamp tissue;

a support mechanism for installing the clamping mechanism, and the support mechanism includes a fixed connection assembly and a drive assembly capable of relative movement with the fixed connection assembly, the distal end of the drive assembly is connected with the two closure members, so as to control the opening or closing of the closure when the drive assembly is relatively moved relative to the fixed connection assembly;

The fixed connection assembly includes a base housing, the base housing is provided with a base inner cavity, and the base inner cavity is provided with a base threaded portion, and the drive assembly includes a drive shaft, and the drive shaft It comprises a driving thread part matched with the base thread part, wherein the thread lead angle of the base thread part and the drive thread part is smaller than the friction angle.

Further, the closure member includes a closed connecting portion and a closed clamping portion;

The drive assembly includes a drive connection block, and the side surface of the drive connection block includes a first mounting surface;

The driving connecting block is hinged with the closing connecting portion through a closing fitting fitting portion provided on the first mounting surface.

Further, the side surface of the drive connection block further includes a second installation surface perpendicular to the first installation surface;

The catching member includes a rigid catching part, a flexible connecting part and a catching connecting part, the flexible connecting part is located between the rigid catching part and the catching connecting part; the second mounting surface is connected with the catching connection The rigid gripping portion is used to cooperate with the closed gripping portion to grip tissue.

Further, the two catching members share one catching connecting portion, and the catching member connecting portion is U-shaped and the symmetrical vertical portions are respectively symmetrically arranged with the second driving connecting block. Mounting surface fixed connection.

Further, the drive connection block is connected with the drive assembly for relative rotation and anti-axial movement.

Further, the drive assembly further includes a drive output shaft with an outer diameter smaller than the drive shaft, and the drive connection block is provided with a connection guide hole whose inner diameter matches the drive output shaft, so The drive output shaft is axially rotatably matched with the connection guide hole.

Further, the drive assembly further includes a positioning sleeve disposed on one side of the distal end of the drive connecting block, and the drive output shaft is fixedly connected to the positioning sleeve through the connection guide hole.

Further, a guide chute is provided on the closed connection part;

The fixed connection assembly is provided with a chute drive member at least partially located in the guide chute, the guide chute at least includes a non-linear segment, and the drive assembly connects the two closed connection parts and is set to When the driving assembly moves relative to the fixed connection assembly, the sliding groove driving member can relatively slide in the guide sliding groove, so as to drive the two closed clamping parts to approach or move away from each other relatively.

Further, the closed connection portion is rotatably connected with the drive assembly, and the connection portion is located on the side of the chute drive member close to the distal end.

Further, the guide chute at least communicates with the first guide groove and the second guide groove, and the arc of the first guide groove is larger than that of the second guide groove.

As mentioned above, the present invention has the following beneficial effects:

(1) When the base housing or the drive shaft is stopped, if only an axial force is applied to the base housing or the drive shaft, there will be no axial displacement, and there is no need to pass a spring sheet or other The structure realizes self-locking, and can stay in any position through screw fit.

(2) After the driving threaded part and the base threaded part are matched, the axial relative movement between the base housing and the driving shaft can be realized by rotating the base housing or the driving shaft. The distance control is more precise and reliable.

(3) Through the setting relationship between the drive connecting block and the positioning sleeve, there is rotational movement between the drive output shaft and the base housing, but there is no rotational displacement between the drive connecting block and the base housing, and the above structure can be used to achieve rotation The driving process does not drive the clamping mechanism to rotate, and the clamping mechanism is moving stably in the axial direction.

(4) Through the improvement of the driving method, the wire chute with non-linear segment is used to cooperate with the driving, which improves the opening angle and capturing distance of the closure, making it easier to capture the leaflet, and the longer the leaflet contacts, making the capture The living valve leaflets are stronger.

Description of drawings

In order to illustrate the technical solutions of the present invention more clearly, the following briefly introduces the accompanying drawings that are required in 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 for those of ordinary skill in the art, other drawings can also be obtained from these drawings without creative effort.

1 is a schematic structural diagram of the clamping mechanism of the application at the mitral valve;

2 is a schematic diagram of the overall structure of the application;

3 is a partial cross-sectional view of the overall structure of the application;

FIG. 4 is a schematic diagram of the principle of the apprehension pieces being located at different positions;

Figure 5(a) is a side view of the closure of the application;

Figure 5(b) is a schematic structural diagram of the closure of the application;

Figure 6 (a)-(d) schematic diagrams of the principle of the closure of the present application;

FIG. 7(a) is a schematic structural diagram of the arresting piece of the present application;

Figure 7(b) is a cross-sectional view of a catch member according to an embodiment of the present application;

Figure 7(c) is a cross-sectional view of a catch member according to another embodiment of the present application;

Figures 8(a)-(e) are parts diagrams of the supporting mechanism of the application;

Figures 9(a)-(c) are schematic diagrams of the movement of the closure member and the catch member of the present application during the blessing process;

Figures 10(a)-(d) are parts diagrams of the clutch mechanism of the application;

Figure 11 is a partial enlarged view of the position where the control wire is disengaged;

Figures 12(a)-(d) are diagrams showing the movement process of the clamping mechanism of the present application to release the closure;

Figures 13(a)-(d) are diagrams showing the movement process of the gripping mechanism of the present application for capturing and fixing.

Detailed ways

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, but not all of the embodiments. In this embodiment, the "proximal end" described refers to the direction close to the operator; the "distal end" refers to the direction away from the operator. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative work fall within the protection scope of the present invention.

Example 1:

In this embodiment, a tissue fixation device with a self-locking function is described. Specifically, the tissue fixation device includes a clamping mechanism 1000 for closing tissue; a supporting mechanism 2000 for installing the clamping mechanism 1000; 2000 Distal clutch mechanism 3000 for implementing detachable connection with the delivery control assembly of the delivery and control tissue closure device.

In this embodiment, before describing the supporting mechanism 2000, the specific structure of the clamping mechanism 1000 needs to be clearly explained: in this embodiment, specifically, the clamping mechanism 1000 includes a pair of closure members 1100 and a pair of closure members 1100 and each closure member. 1100 corresponds to a pair of catching members 1200; the closure member 1100 is opened and closed by the drive assembly 2200, and the catching member 1200 is opened and closed by the manipulation wire 610. When clamping the tissue, the inner side of the closure member 1100 and the catching member The fit on the outside of the 1200 enables clamping. In this embodiment, the heart valve clamping is used as the implementation scene to illustrate the specific usage principle of the fixation device for clamping tissue in the present application. Referring to FIG. Specifically, the conveying control assembly includes a push shaft 600 for pushing the fixing device to a designated position and a clutch mechanism 3000 for detachably connecting the pushing shaft 600 and the fixing device; in an embodiment of the present invention, the pushing shaft 600 has an inner The lumen rod or hollow tubular body, made of biocompatible material. In this embodiment, the clamping shaft is in the shape of a round rod or a round tube, and the surface of the pushing shaft 600 is smooth, so as to prevent the pushing shaft 600 from damaging the valve leaflets or hooking the chordae tendineae. The push shaft 600 first enters the surgical channel 600 together with the catheter 500, and after reaching the attachment to the lesion, the push shaft 600 extends out of the catheter 500 to deliver the fixation 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 covering layer, which is made of a biocompatible material and completely covers the periphery of the clamping mechanism 1000. The layer can prevent the device from damaging the tissue, and the outer surface of the fixation device can be completely protected by the protective covering when the fixation device is left in the heart as an implant.

After reaching the position of the lesion, the position where the anterior leaflet and the posterior leaflet of the heart valve cannot be properly aligned can be clamped through the cooperation of the closure member 1100 and the catch member 1200 of the clamping mechanism 1000 in this embodiment, so that the non-aligned Parts are brought together to allow the mitral valve to close completely or open to a smaller area, thereby reducing or treating "mitral regurgitation."

After the mitral valve is clamped, the fixation device is separated from the delivery control assembly through the clutch mechanism 3000, and the fixation device remains at the lesion to maintain the fixation of the valve.

After explaining the basic structure of the clamping mechanism, the structure and principle of the supporting mechanism 2000 will be described with reference to Fig. 3 and Fig. 8 according to the foregoing. The support mechanism 2000 includes a fixed connection assembly 2100 and a drive assembly 2200 that can move relative to the fixed connection assembly 2100. The distal end of the drive assembly 2200 is connected with the two closure members 1100, so that when the drive assembly 2200 moves relative to the fixed connection assembly 2100, Control the opening or closing of the closure member 1100; specifically: the closure member 1100 of the clamping mechanism 1000 includes a closed connection part 1120 and a closed clamping part 1110, and the closed clamping part 1110 is used to cooperate with the grasping member 1200 to clamp tissue . The closed connection part 1120 is provided with a guide chute 1121; the fixed connection assembly 2100 is provided with a chute driving member 850 which is at least partially located in the non-linear guide chute 1121. The two closed connecting parts 1120 are connected and arranged so that when the driving assembly 2200 is relatively moved relative to the fixed connecting assembly 2100, the sliding groove driving member 850 can slide relatively in the guiding sliding groove 1121, so as to drive the two closed clamping parts 1110 to be relatively close or keep away.

Further, the base housing further includes a base support lug 2110 disposed at the distal end, and the chute driving member 850 is disposed outside the base support lug 2110 . By controlling the relative movement of the drive assembly 2200 relative to the chute drive member 850 , the opening or closing of the closure member 1100 is controlled.

Specifically, the fixed connection assembly 2100 includes a base housing, the base housing is provided with a base inner cavity 2130, and the base inner cavity 2130 is provided with a base threaded portion 2131, the driving assembly 2200 includes a driving shaft 2230, and the driving shaft 2230 It includes a driving thread portion 2231 matched with the base thread portion 2131, wherein the thread lead angle of the base thread portion 2131 and the drive thread portion 2231 is smaller than the friction angle.

In this example, after the driving threaded portion 2231 and the base threaded portion 2131 are matched, since they have the same thread pitch and cross-sectional shape, the base housing and the driving shaft 2230 can both be realized by rotating the base housing or the driving shaft 2230. axial relative motion. Because the helix angle of the helical ring groove is smaller than the friction angle between the contact surfaces of the two helical grooves, when the base housing or the drive shaft 2230 is stopped, if only an axial force is applied to the base housing or the drive shaft 2230, It also does not experience axial displacement. Thereby, the self-locking function is realized, and the self-locking function does not need to be realized by means of spring sheets or other structures as in the prior art, and it can stay at any position through screw fitting.

The drive assembly 2200 also includes a drive output shaft 2210 with an outer diameter smaller than the drive shaft 2230 at the distal end of the drive shaft 2230. The drive connection block 2310 is provided with a connection guide hole 2311 whose inner diameter matches the drive output shaft 2210. The connection guide hole 2311 is axially rotatably fitted. The drive assembly 2200 further includes a positioning sleeve 810 disposed on the distal side of the drive connecting block 2310 . The drive output shaft 2210 extends through the connecting guide hole 2311 and then extends into the positioning sleeve mounting hole 811 of the positioning sleeve 810 to be fixedly connected to the positioning sleeve 810 . .

According to the above structural description, the present embodiment discloses the motion cooperation between the drive output shaft 2210 and the drive connection block 2310 , and the output end of the drive output shaft 2210 outputs the pushing force and the pulling force to the drive connection block 2310 to realize the drive connection block 2310 Axial movement, but since there is rotational movement between the drive output shaft 2210 and the base housing, and there is no rotational displacement between the drive connection block 2310 and the base housing, the above structure can be used to realize the process of rotational driving, but it is not The clamping mechanism will be driven to rotate, and the clamping mechanism is moving stably in the axial direction. The positioning sleeve 810 can be a tubular part, 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 can be by welding, interference fit, or mechanical connection. A mechanical connection method is disclosed as follows: the positioning sleeve 810 can be provided with a positioning sleeve positioning hole 812 in the radial direction, and at the same time, a driving output shaft positioning hole 2211 is radially provided at the position where the output end of the driving output shaft 2210 and the positioning sleeve 810 cooperate. The pin shaft 840 is built into the positioning hole 812 and the driving output shaft positioning hole 2211 .

Regarding the clamping mechanism 1000 , referring to FIGS. 4-9 and FIGS. 12-13 again, in this embodiment, specifically, the distal end of the closed connection portion 1120 is rotationally connected with the drive assembly 2200 , specifically, with the drive assembly 2200 . For the distal rotational connection, in this embodiment, the closed connection portion 1120 is provided with a connection portion shaft hole 1122, which is connected to the drive assembly 2200 through a rotating shaft. In other embodiments, other hinged manners may also be selected. Before the fixing device is delivered to the designated position, the closing gripping portion 1110 is at the initial position, as shown in FIG. 12( a ), the chute driving member 850 is located at the proximal end of the guiding chute 1121 , and the closing gripping portion 1110 is at this time. In the closed state, under the drive of the drive assembly 2200, due to the cooperation of the chute driver 850 and the guide chute 1121, when the rotational connection between the drive assembly 2200 and the closed connection part 1120 moves toward the proximal end, that is, the connection part shaft hole 1122 When moving toward the proximal end, the guide chute 1121 moves with the trend toward the proximal end synchronously. Since the chute driving member 85 does not move, that is, the chute driving member 85 is moving distally relative to the guiding chute 1121, and the clamp is closed. In order to adapt to the change of the distance of the holding portion 1110 , the chute driving member 850 will force the chute 1121 to rotate moderately with respect to the connecting portion shaft hole 1122 , thereby realizing the closed clamping portion 1110 to rotate around the connecting portion shaft hole 1122 . The closing clamping portion 1110 will turn outward with the shaft hole 1122 of the connecting portion as the axis, so as to reach the state shown in FIG. 12(b) and (c), and further drive the shaft hole 1122 of the connecting portion to move toward the proximal end, closing the clamping portion 1110 can reach the state as shown in FIG. 12(d), at this time, the two closed clamping parts 1110 form an included angle of 180° relative to each other, and the distance between the ends reaches the maximum distance from the capture.

Due to the design of the guide chute 1121, after the two closed clamping parts 1110 form an included angle of 180°, they can be further turned so as to open up to an obtuse angle as shown in FIG. When the fixation device needs to be withdrawn from the heart due to accuracy or other problems, since the two closed clamping parts 1110 are relatively obtuse, during the withdrawal process, the contact surface with the tissue tends to incline outward, and the tissue will not be caught and withdrawn. The process is smooth and safe. Specifically, the principle of the process of closing the clamping portion 1110 to realize the above-mentioned process of opening the angle through the mutual cooperation between the chute driving member 850 and the guide chute 1121 will be described in detail later.

In this embodiment, the opening and closing process of the closing clamping portion 1110 is performed by the driving component 2200 moving relative to the chute driving component 850, while the sliding channel driving component 850 and the fixed connection component 2100 connected thereto do not move. Therefore, during the process from the initial position of the closed clamping portion 1110 of the closure member 1100 to the open position, the closed connecting portion 1120 at the distal end thereof is moved toward the proximal end. In the present invention, the closure member 1100 has two kinds of compound motions, which enables the closure member 1100 to obtain a wider deployment distance in the radial direction. And when it is in the initial position, the closing connection part 1120 has no additional other mechanism, so the height of the overall fixing device is reduced, which is more convenient for turning during transportation. Based on this, the closing part 1100 can also be set with a larger length accordingly. Thereby having a larger capture distance.

After the closing gripping portion 1110 cooperates with the grasping member 1200 to grip the tissue, the closing gripping portion 1110 needs to be further folded. The clamping part 1110 has the effect of pulling to the distal end, so that the closing process has a "biting" motion characteristic. On the premise that the tissue is firmly clamped, the valve leaflet on the closing clamping part 1110 will obtain a "pulling" effect, The leaflets and closure clip 1110 are brought into firmer contact.

The guide chute 1121 includes at least two guide grooves, a first guide groove and a second guide groove that are communicated with each other, and the arc of the first guide groove is larger than that of the second guide groove. Figure 6(a) is the realization form of the wire chute according to the first embodiment of the application, which is divided into a first guide groove, a second guide groove and a third guide groove from the distal end to the proximal end. The first guide groove And the third guide groove is an arc segment, and the second guide groove is a straight line segment. Among them, the arc feature has a larger change in the flip angle, but the moment is small, the moment changes nonlinearly, and the variation range is small, and there is a moment of In the straight line feature, the moment is large, and the moment changes linearly and stably, the variation range is large, there is no moment dead point, but the change of the flip angle is small, therefore, the guide chute 1121 is set in turn with an arc-shaped first guide The slot, the straight second guide slot and the arc-shaped third guide slot make the opening of the closure at the initial position and the maximum opening angle position require less torque and faster transformation speed than the middle capturing process. In the capture stage, the system reliability is improved, and the slower angle change is convenient for the operator to operate finely.

6( a ) combined with FIGS. 6( c ) and ( d ), the chute driving member 850 is in the shape of a circular axis and is located in the guiding chute 1121 , and the width of the guiding chute 1121 matches the outer diameter of the chute driving member 850 , in the initial unopened position, the chute driving member 850 is located at the proximal end, as shown in FIG. 6(c), that is, the most proximal end of the third guide slot, and at this time the sliding slot driving member 850 and the closing member matching portion 2320 are located The distance between them is h1. During the process of opening the closed clamping portion 1110, the sliding groove driving member 850 slides to the distal end of the third guide groove, and enters the second guide groove at the farthest end of the third guide groove. When the closed clamping portion 1110 has already rotated at an angle of α1, the chute driving member 850 slides further to the distal end, and when the sliding chute driving member 850 is located at the farthest end of the second guide slot, that is, the end of the straight section, it is closed at this time. The clamping portion 1110 has been rotated by an angle of α2, and the distance between the chute driving member 850 and the closing member matching portion 2320 is h2, as shown in FIG. 6(d); When the groove slides to the far end to reach the farthest end of the guide chute 1121, the closed clamping part 1110 has already rotated by an angle of α3; among them, the value ranges of α1, α2, α3, h1, and h2 can be selected according to actual needs , in this embodiment, preferably the value range of α1 is 30°～45°, more preferably 35°～40°, and even more preferably 40°; the value range is 55°～70°, Further preferably, it is 60° to 70°, even more preferably 65°; the value range of α3 is 120° to 150°, more preferably 125° to 135°, and even more preferably 130°; Preferably, the value range of h1 is 15-16mm, more preferably 15.5mm, the distance of h2 is 5-7mm, more preferably 6mm; according to the above description, it can be seen that the closing clamping part 1110 needs to be driven to close the rotation angle α2 The moving distance of the fitting portion 2320 relative to the chute driving member 850 is h2-h1. When α2 is 65°, h1 is 15.5mm, and h2 is 6mm, that is, when the two closing clamping portions 1110 are relatively opened at 130°, the moving distance of the closing element matching portion 2320 is 9.5 mm. Due to the matching of the arc-shaped first guide groove, the straight second guide groove and the arc-shaped third guide groove, not only the closing member is opened at the initial position and the maximum opening angle position is compared with the middle capturing process, the speed of change Faster, and the angle changing speed is slowed down in the capture section, making the capture more stable, and compared with the ordinary linear chute, the driving distance required by the present application to reach the preset capture angle is smaller, and the precision The operating position is more secure and reliable than the curve groove.

Fig. 6(b) is the realization form of the guide chute 1121 of another embodiment of the application, the distal end to the proximal end are divided into a first guide groove and a second guide groove, the first guide groove arc The guide groove is a straight segment, and its main consideration is that it can be quickly retracted when the maximum angle is opened to the capture position, and in the process of capturing tissue, the angle change speed is slowed down in the capture segment through the straight segment, making the capture more stable. Specifically, the corresponding angle change from the closest section of the guide chute 1121 to the junction of the first guide slot and the second guide slot is θ1, and the change angle of the straight section of the chute driver 850 in the guide chute 1121 is θ1, When further moving to the farthest end, the opening angle of the single closed clamping portion 1110 is θ2, wherein, preferably, the value range of θ1 is 40°˜60°, and the value range of θ2 is 120°˜140°.

3 and 8, the drive assembly 2200 includes a movable seat 2300, and specifically includes a drive connection block 2310. The side surface of the drive connection block 2310 includes a first installation surface and a second installation surface that are perpendicular to each other. The drive connection block 2310 passes through The closure fitting part 2320 provided on the first installation surface is hingedly connected with the closure connecting part 1120 , so as to drive the movement of the closure fitting fitting part 2320 , and further realize the relative movement of the guide chute 1121 and the chute driving member 850 .

Further, referring to FIG. 7 , in the present application, the catching member 1200 includes a rigid catching portion 1210 , a flexible connecting portion 1220 , and a catching connecting portion 1230 connected in sequence, and the flexible connecting portion 1220 is located between the rigid catching portion 1210 and the catching connecting portion 1230 . between the catching connection parts 1230; the second installation surface is fixedly connected with the catching connection part 1230;

In this example, the catch is used to cooperate with the closure to capture the active leaflets, and the captured leaflets will be located between the closure and the catch. The catch connecting part is used for connecting with the second mounting surface. The natural state of the catcher shows the unfolded bird wings. Here, the flexible connection part is specifically a deformable but resilient part. When an external force is applied to the rigid part of the catcher, the flexible connection part will be elastic. Deformation, changing the angle between the rigid part of the catch and the axial direction, and realizing the flip of the catch. When the movable leaflet to be captured is located above the closure on one side of the catch, it is only necessary to remove the external force of its inversion, and the elastic deflection The sexual part will momentarily perform the action of restoring its natural state shape, at which point the leaflet will be captured between the closure and the rigid part of the catch. The rigid part in the valve capture is mainly used to fix the movable valve, and its structure must have a certain rigidity to prevent the captured valve leaflets from pushing away the capture member and escaping.

Further preferably, the rigid catching portion 1210 includes a rigid surface 1211 and a catching protruding thorn 1212 disposed outside the rigid surface, and the rigid surface 1211 has a uniform thickness and is arranged in a bent shape,

The rigid surface 1211 of the grabbing clip has the characteristics of rigid cross-section, and its cross-sectional shape is curved as shown in 7(b) or bent as shown in 7(c). The rib makes the thin-walled section of the sheet have a high flexural section coefficient, which improves the rigidity of the rigid part of the gripping clip without the need to add an additional layer of rigidity-enhancing components. The control wire in the assembly is controlled, so that the control wire exerts a force on the catch clip at the guide wire hole 1213 to realize the overturning motion of the catch clip.

In this example, the two catching members 1200 share one catching connecting portion 1230 , and the catching member connecting portions 1230 are U-shaped and symmetrical vertical portions are respectively fixedly connected to the second mounting surfaces symmetrically arranged on the driving connecting block 2310 . The catching connecting portion 1230 can be fixedly connected with the driving connecting block 2310 by hinged, riveted or welding, so that the catching member 1200 can move axially with the driving connecting block 2310 . Taking the chute driving member 850 as a reference point, when the driving connecting block 2310 is axially approached in the direction of the chute driving member 850 , the closure member 1100 will perform the unfolding and flipping motion, and the catch member 1200 as a whole also has an approach close to the chute driving member 850 . Axial movement. At the same time, if a turning force toward the chute driving member 850 is applied to the rigid part of the catch member 1200 at the same time, the catch member 1200 will be turned over in the direction of the chute driving member 850 . The flipping force on the catch 1200 is removed, and the leaflets are clamped between the closure 1100 and the catch 1200 . In one of the embodiments, the natural state of the catch 1200 is an open state, and the manipulation wire 610 is used to constrain the catch 1200 to a retracted state. In another embodiment, the catching member 1200 may also be a flexible member, and the flipping catching can be realized directly by pushing the manipulation wire 610 .

Further, when the drive link block 2310 begins to move away from the chute drive member 850 in the axial direction, the closure member 1100 will perform a closing flipping motion with the captured leaflets and the deployed catch member 1200, while the drive link block 2310 will also With the entirety of the catch 1200 moving axially in the direction away from the chute driving member 850, at this time, the catch 1200 and the valve leaflets will also produce relative displacement, or have a tendency to relative displacement. And because the pressure generated by the elastic deformation of the catch member 1200 is exerted on the valve leaflet, frictional force will be generated on the contact surface between the catch member 1200 and the valve leaflet that is relatively displaced, and the friction force of the valve leaflet applied by the catch member 1200 will be generated. The direction is towards the drive link block 2310, which gives the catcher blade a "pulling" motion characteristic to the leaflets. Adding some friction-increasing features or spur features on the rigid portion of the catch member 1200, such as the catch spur 1212 in this embodiment, will make the effect of “pulling” the valve leaflets more obvious. The moving proximal element, the present invention will make the combination of the leaflet and the fixation device more secure.

Further, in this embodiment, referring to FIG. 3 , the closed clamping portion 1110 includes a free end and a connecting end connected to the closed connecting portion 1120 , and the outer surface of the closed clamping portion 1110 is at least partially in a direction from the connecting end to the free end. Inward contraction trend. Due to the concave feature of the cup opening of the closed clamping portion 1110, the contact area with the valve leaflet can be increased when the valve is clamped. When the valve is clamped and fixed with the catch member 1200, the valve clamped in the concave mouth of the cup can limit the radial displacement of the fixing device on the valve leaflet. The flanging feature is used to avoid damage to the valve from the edge of the closed clip 1110 . After the fixing device finally closes the valve leaflets, the inwardly curved feature of the closing clamping portion 1110 is closed, so that a cuff is formed at the ends of the closing clamping rod portions on both sides, which makes the valve leaflet clamp more firmly in the axial direction.

In addition, the clamping mechanism 1000 of other embodiments of the present invention can also be used to alleviate or treat "tricuspid regurgitation", that is, an additional one is added to the original pair of the closure member 1100 and the capture member 1200 , for the treatment of "tricuspid regurgitation". The principle and structure thereof are the same as those used to solve the mitral valve regurgitation in the embodiment of the present invention, and are not repeated here. It can be understood that other embodiments of the present invention can also be applied to other minimally invasive surgical operations that need to clamp several sheets of tissue, and the number of the closure member 1100 and the catch member 1200 is based on actual use Demand changes.

The present invention also provides a system for clamping tissue, specifically a system for clamping a valve in this embodiment, including the aforementioned fixing device, that is, including a clamping mechanism 1000 for closing tissue, for The supporting mechanism 2000 of the clamping mechanism 1000 is installed, and the supporting mechanism 2000 includes a driving assembly 2200 for driving the clamping mechanism 1000 to open and close;

and the conveying control assembly, the conveying control assembly includes a push shaft 600 for pushing the fixing device to a designated position and a clutch mechanism 3000 for detachably connecting the pushing shaft 600 and the fixing device;

In this embodiment, the clutch mechanism 3000 includes a joystick 3100 that is anti-rotationally and axially detachable from the drive assembly 2200, and the joystick 3100 rotates to drive the drive assembly 2200 to move axially; When moving toward the proximal end, the clutch mechanism 3000 is driven to disengage from the fixing device. The separation principle of the clutch mechanism 3000 and the support mechanism 2000 will be explained below specifically with reference to Figure 3, Figure 8 and Figure 10:

Wherein, the support mechanism 2000 for installing the clamping mechanism 1000 includes a fixed connection assembly 2100 and a drive assembly 2200 that can move relatively with the fixed connection assembly 2100, wherein, specifically, the drive assembly 2200 includes a drive shaft 2230, and the drive shaft 2230 includes The drive thread part 2231 matched with the base thread part 2131, there is a rotational movement between the drive output shaft 2210 and the base housing to realize the shaft movement of the drive shaft 2230, and the rotation of the drive output shaft is realized through the joystick in the clutch mechanism 3000 3100 applies a rotational moment, and specifically includes a joystick clutch end 3120 and a joystick support portion 3130 that is axially detachable and anti-rotationally connected to the drive assembly 2200; The end 3120 is connected with the clutch end 2220 of the transmission rod in an anti-rotational manner. When the tension between the clutch end 3120 of the joystick and the clutch end 2220 of the transmission rod is greater than the preset value, the clutch end 3120 of the joystick is separated from the clutch end 2220 of the transmission rod; The helix angle of the helical ring groove is smaller than the friction angle between the contact surfaces of the two helical grooves, so when the base housing or the drive shaft 2230 is stopped, if only an axial force is applied to the base housing or the drive shaft 2230, it will also No axial displacement will occur. Therefore, when it is necessary to separate the clutch end 3120 of the lever from the clutch end 2220 of the transmission lever, it is only necessary to pull the lever 3100 toward the proximal end in the axial direction, and the clutch end of the clutch end 2220 of the transmission lever remains stationary. You can pull it off when the preset value is reached.

Specifically, in this embodiment, the specific implementation structure of pulling off when the preset value is reached is as follows:

One of the clutch end 3120 of the joystick and the clutch end 2220 of the transmission rod is provided with a deformable buckle 3121, and the deformable buckle 3121 can be made of elastic biocompatible materials, such as some biocompatible polymer materials, and another One is provided with a clutch connection groove 2222. The clutch connection groove 2222 is provided with a clamping shaft 820 that is matched and connected with the deformable buckle 3121. The clamping shaft 820 is inserted into the coupling shaft hole 222. Specifically, the deformable buckle 3121 It has a bayonet 3122 and a bayonet 3123 which is matched with the clamping shaft 820 after passing through the bayonet 3122; When the tension between the clutch end 3120 of the rod and the clutch end 2220 of the transmission rod is greater than the preset value, the deformable buckle 3121 is disengaged from the clamping shaft 820. In this embodiment, the deformable buckle 3121 is arranged on the clutch end 3120 of the joystick. The clutch connection groove 2222 is provided on the clutch end 2220 of the transmission rod, and can also be provided in reverse.

In order to separate the outer casing of the support mechanism 2000 from the outer casing of the clutch mechanism 3000 during the separation process between the clutch end 3120 of the joystick and the clutch end 2220 of the transmission lever, specifically, in this embodiment, the clutch mechanism 3000 is also provided with There is a coupling seat 3300 detachably connected with the base clutch end 2120, a clip 3200 for connecting the base clutch end 2120 with the coupling seat 3300; Move between the second positions, and when the joystick 3100 moves proximally from the second position, the joystick support portion 3130 can drive the clip 3200 to move proximally at the same time, so that the coupling seat 3300 and the base clutch end 2120 It can be relatively separated, so that the coupling seat 3300 and the base clutch end 2120 can also be separated synchronously during the separation process of the clutch end 3120 of the joystick and the clutch end 2220 of the transmission rod;

Specifically, in this embodiment, the coupling seat 3300 includes a coupling seat connecting end 3310, a coupling seat clutch end 3320, and a coupling seat inner cavity 3330 penetrating the coupling seat 3300. The clip 3200 is arranged in the coupling seat inner cavity 3330, and the coupling seat The clutch end 3320 is connected to the base clutch end 2120 through the clip 3200, and the coupling base connection end 3310 is used to connect with the conveying device.

The main body of the base clutch end 2120 is an extension of the base tubular structure. The coupling base clutch end 3320 can be sleeved on the base clutch end 2120 or inserted into the base clutch end 2120. The contact surfaces of the two clutch ends are respectively called the base mating surface. and the mating surface of the coupling seat, wherein the mating surface of the base is provided with a base clamping hole 2121 in the radial direction, the corresponding coupling seat mating surface is provided with a coupling seat clamping hole 3321 with the same orientation in the radial direction, and the coupling end 3320 of the coupling seat is provided with a coupling The seat clamping hole 3321, the base clutch end 2120 is provided with a base clamping hole 2121 corresponding to the coupling seat clamping hole 3321; The buckle 3220 is relatively fixed with the clutch end 2120 of the base; and the buckle 3220 is arranged so that when the clip 3200 moves proximally relative to the coupling seat 3300, the buckle 3220 is disengaged from the coupling seat hole 3321 and/or the base The latching hole 2121 enables the coupling seat 3300 to be relatively separated from the clutch end 2120 of the base.

The buckle 3220 is made of a flexible material. When the clip 3200 moves proximally relative to the coupling seat 3300, the buckle 3320 is deformed, so that the buckle can directly disengage from the coupling seat hole 3321 and the base hole 2121 And there will be no springback to cause effective separation. The material of the buckle 3220 is made of biocompatible plastic or metal that does not rebound after bending.

Further, in this embodiment, the clamping member 3200 further includes a clamping claw bottom ring 3230 and a clamping claw connecting rod 3210 which is the same in number as the clamping buckle 3220 and connects the clamping buckle 3220 and the clamping claw bottom ring 3230. The clamping claw bottom ring 3230 There is a bottom ring opening; the number of the jaw connecting rods 3210 is 3-6, and they are evenly connected to the side of the jaw bottom ring 3230 . Preferably, the number of the claw connecting rods 3210 is 3; wherein, the axial or rod-shaped joystick support portion 3130, whose radial surface resists the movement of the buckle 3220 toward the center, can limit the buckle 3220 from being clamped from the base. The hole 2121 and the coupling seat clamping hole 3321 are accidentally disengaged, thereby maintaining the connection between the base clutch end 2120 and the coupling seat 3300;

The joystick 3100 further includes a joystick connecting end 3110 connected to the proximal end of the joystick support portion 3130 , the proximal end of the joystick connecting end 3110 is used to connect with the driving source after passing through the opening of the bottom ring, and the proximal end of the joystick support portion 3130 The outer diameter is larger than the inner diameter of the bottom ring opening.

The length of the joystick support portion 3130 is smaller than the length of the claw connecting rod 3210, and the outer diameter of the joystick support portion 3130 is set so that when the joystick support portion 3130 is located in the coupling seat hole 3321, the outer surface of the joystick support portion 3130 blocks the card The buckle 3220 is disengaged from the coupling seat clip hole 3321 and the base clip hole 2121 , so the clip 3220 is deformed only when the lever support 3130 contacts the pawl bottom ring 3230 and moves further proximally.

Based on the above structure, when the base clutch end 2120 and the coupling seat 3300 need to be separated, the joystick moves toward the jaw bottom ring 3230 under the action of the axial force. When the jaw bottom ring 3230 is squeezed by the joystick At the same time, the joystick support part 3130 is also separated from the buckle 3220, and does not restrict its radial movement. Under the condition of sufficient external force, the buckle 3220 can be pulled off from the base hole 2121 and the coupling seat hole 3321, and then The separation of the base clutch end 2120 and the coupling seat 3300 is achieved.

To further illustrate the above example, the clutch end 3320 of the coupling seat is sleeved on the clutch end 2120 of the base. As shown in FIG. 11 , the clip 3200 includes a control wire limit groove 3322, which is used in the conveying control assembly to control the clamping mechanism 1000. The head end of the control wire 610 opened and closed by the catch member 1200 has an expansion feature, which is arranged in the base end hole 2122 , and its minimum size is larger than the control wire limit groove 3322 and smaller than the base end hole 2122 . When the coupling seat 3300 is connected with the clutch end 2120 of the base, the control wire 610 is restricted from being disengaged by the control wire limiting groove 3322;

In one of the embodiments, the joystick 3100 is provided with a lumen that communicates through its proximal end to the joystick clutch end 3120 , because unlike the prior art, the joystick needs to be solid and then connected by threads, the present application Since the clutch connection slot 2222 is matched with the deformable buckle 3121 in the middle, the joystick can be hollow inside, and then a flexible shaft for controlling the direction is arranged, thereby saving the external operation structure for controlling turning.

In order to specifically illustrate the specific application of the device of this embodiment in the operation process, by combining the structure specifically described in this embodiment, the following takes the mitral valve repair process as an example to illustrate the operation method of the system for clamping tissue of the present application :

Step 1: The fixation device attached thereto is advanced through the pusher shaft 600 from the left atrium, through the mitral valve to the left ventricle. At this time, the closure member 1100 of the clamping mechanism 1000 is in a folded state, as shown in FIG. 12( a ).

Step 2: Adjust the relative position of the valve fixing device and the mitral valve by pushing the shaft 600, so that the two closing parts 1100 of the fixing device are respectively close to the anterior leaflet and the posterior leaflet of the mitral valve, and then rotate the drive shaft 2230, the base The threaded portion 2131 cooperates with the driving threaded portion 2231 to make the driving connecting block 2310 move to the distal end. Taking the sliding groove driving member 850 as the reference point, when the driving connecting block 2310 is axially approached in the direction of the sliding groove driving member 850, the closing member 1100 will move. Deploy the flipping motion to reach the state shown in Figure 12(b) and (c), and the closure member can also be further flipped to the state shown in Figure 12(d), at this time, the ends of the two closure members 1100 have a maximum distance, After the two closed clamping parts 1110 form a relative angle of 180°, they can be further flipped, so as to open up to an obtuse angle as shown in Figure 13(a), which can be used for inaccurate positioning or other problems that require fixing When the device is withdrawn from the heart, since the two closed clamping portions 1110 are relatively obtuse, during the withdrawal process, the contact surface with the tissue tends to incline outward, and the tissue will not be caught, and the withdrawal process is smooth and safe.

Step 3: After the two closure members 1100 capture the valve leaflets, the control wire 610 is used to make the capture member 1200 flip toward the closing clamping portion 1110, and the valve leaflet is clamped between the closure member 1100 and the capture member 1200. As shown in Figure 13(b);

Step 4: When the driving connecting block 2310 starts to move axially away from the direction of the chute driving member 850, the closing member 1100 will carry out the closing and flipping motion with the captured leaflets and the unfolded capturing member 1200, and at the same time, the driving connecting block 2310 also The catching member 1200 will move axially away from the direction of the chute driving member 850 as a whole to reach the state shown in Figure 13(c), (d), at this time, the catching member 1200 will also have a relative displacement with the valve leaflet. , or the relative displacement trend. And because the pressure generated by the elastic deformation of the catch member 1200 is exerted on the valve leaflet, frictional force will be generated on the contact surface between the catch member 1200 and the valve leaflet that is relatively displaced, and the friction force of the valve leaflet applied by the catch member 1200 will be generated. The direction is towards the drive link block 2310, which gives the catcher blade a "pulling" motion characteristic to the leaflets.

Through the system for clamping tissue of the present application to repair the heart valve, closing the clamping part has the effect of pulling the distal end, so that the closing process has a "biting" motion characteristic. On the premise that the tissue is firmly clamped, the closing clamp The leaflets on the holder will have a "pulling" effect, using a guide wire chute with a non-straight segment to cooperate with the drive, which improves the opening angle and capture distance of the closure, making it easier to capture the leaflets, longer valve Leaflet contact makes the captured leaflets more secure.

In this document, the related terms such as front, rear, upper and lower are defined by the positions of the components in the drawings and the positions between the components, which are only for the clarity and convenience of expressing the technical solution. It should be understood that the use of the locative words should not limit the scope of protection claimed in this application.

The above-described embodiments and features of the embodiments herein can be combined with each other without conflict.

The above disclosure is only a preferred embodiment of the present invention, and of course, it cannot limit the scope of the rights of the present invention. Therefore, the equivalent changes made according to the claims of the present invention are still within the scope of the present invention.

Claims

A tissue fixation device with a self-locking function, characterized in that it comprises:

A clamping mechanism (1000) for closing tissue, comprising a pair of closure members (1100) and a gripper provided corresponding to each closure member (1100) for cooperating with the closure member (1100) to clamp tissue catch(1200);

A supporting mechanism (2000) for installing the clamping mechanism (1000), and the supporting mechanism (2000) includes a fixed connection assembly (2100) and a drive assembly (2100) capable of relative movement with the fixed connection assembly (2100). 2200), the distal end of the drive assembly (2200) is connected with the two closure members (1100), so that when the drive assembly (2200) is relatively moved relative to the fixed connection assembly (2100), the control of the opening or closing of the closure (1100);

The fixed connection assembly (2100) comprises a base shell, a base inner cavity (2130) is arranged in the base shell, and a base threaded portion (2131) is arranged in the base inner cavity (2130), The drive assembly (2200) includes a drive shaft (2230), and the drive shaft (2230) includes a drive thread portion (2231) that cooperates with the base thread portion (2131), wherein the base thread portion (2131) is connected to the base thread portion (2131). The lead angle of the driving thread (2231) is smaller than the friction angle.
A tissue fixation device with self-locking function according to claim 1, characterized in that:

The closure member (1100) comprises a closed connection part (1120) and a closed clamping part (1110);

The drive assembly (2200) includes a drive connection block (2310), and a side surface of the drive connection block (2310) includes a first mounting surface;

The driving connecting block (2310) is hinged with the closing connecting part (1120) through a closing fitting fitting part (2320) provided on the first installation surface.
A tissue fixation device with self-locking function according to claim 2, characterized in that:

The side surface of the drive connection block (2310) further includes a second mounting surface perpendicular to the first mounting surface;

The catching member (1200) includes a rigid catching part (1210), a flexible connecting part (1220) and a catching connecting part (1230), and the flexible connecting part (1220) is located between the rigid catching part (1210) and the catching part (1230). between the catching connecting parts (1230); the second mounting surface is fixedly connected with the catching connecting part (1230), and the rigid catching part (1210) is used to cooperate with the closing clamping part (1110) Clamp the tissue.
The tissue fixation device with a self-locking function according to claim 3, characterized in that, the two catching members (1200) share one of the catching connecting parts (1230), and the catching members are connected to The parts (1230) are U-shaped and the symmetrical vertical parts are respectively fixedly connected to the second installation surfaces symmetrically arranged on the drive connecting block (2310).
The tissue fixation device with a self-locking function according to any one of claims 2-4, characterized in that the drive connecting block (2310) and the drive assembly (2200) rotate relative to each other and resist axial movement connect.
A tissue fixation device with a self-locking function according to claim 5, characterized in that, the drive assembly (2200) further comprises an outer diameter disposed at the distal end of the drive shaft (2230) smaller than the drive shaft (2230) of the drive output shaft (2210), the drive connection block (2310) is provided with a connection guide hole (2311) whose inner diameter matches the drive output shaft (2210), and the drive output shaft (2210) is connected to the drive output shaft (2210). The connection guide hole (2311) is axially rotatably fitted.
The tissue fixation device with a self-locking function according to claim 6, wherein the driving assembly (2200) further comprises a positioning sleeve (810) disposed on the distal end side of the driving connecting block (2310). ), the drive output shaft (2210) is fixedly connected to the positioning sleeve (810) through the connection guide hole (2311).
A tissue fixation device with self-locking function according to claim 1, characterized in that:

A guide chute (1121) is provided on the closed connecting portion (1120);

The fixed connection assembly (2100) is provided with a chute driving member (850) at least partially located in the guide chute (1121), and the guide chute (1121) includes at least a non-linear segment, and the drive The assembly (2200) connects the two closed connection parts (1120) and is arranged so that when the drive assembly (2200) moves relative to the fixed connection assembly (2100), the chute drive member (850) can be The guide chute (1121) slides relatively inside, so as to drive the two closed clamping parts (1110) to be relatively close to or away from each other.
The tissue fixation device with a self-locking function according to claim 8, wherein the closed connection portion (1120) is rotatably connected with the drive assembly (2200), and the connection is located at the chute drive The side of the piece (850) near the distal end.
The tissue fixation device with a self-locking function according to claim 8, characterized in that, the guide chute (1121) is at least a first guide slot and a second guide slot that are connected, and the first guide slot The arc is greater than the second guide groove.