Valve repair instrument

Abstract

A valve repair instrument is provided that includes a leaflet capture assembly and a suture implant assembly. The valve leaflet capturing assembly comprises a first clamping piece, a second clamping piece, a limiting piece and a transmission assembly, through transmission of the transmission assembly, the second clamping piece can be opened relative to the first clamping piece to form an included angle, or can be closed to capture valve leaflets of a valve, and the limiting piece is used for limiting the valve leaflets of the valve. The restriction member restricts the captured leaflet between the first clamp member and the second clamp member. The suture implanting assembly comprises a puncture needle and a suture which is contained in the puncture needle and can be pushed, the first clamping piece is provided with a guide groove, after the valve leaflet capturing assembly captures and clamps the valve leaflet, the puncture needle penetrates out of the guide groove to puncture the valve leaflet, and the suture is pushed out of the puncture needle to the other side of the valve leaflet.

Description

Technical Field

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

[0002] The atrioventricular valves such as the mitral valve and tricuspid valve are one-way valves in the heart. Normal and healthy atrioventricular valves can control the flow of blood from the atria to the ventricles, while preventing blood from flowing from the ventricles to the atria. Figure 1 As shown, the mitral valve MV is a one-way valve located between the left atrium LA and the left ventricle LV of the heart, which can control the blood flow from the left atrium LA to the left ventricle LV, and prevent the blood from flowing from the left ventricle LV to the left atrium LA; the tricuspid valve TV is a one-way valve located between the right atrium RA and the right ventricle RV of the heart, which can control the blood flow from the right atrium RA to the right ventricle RV, and prevent the blood from flowing from the right ventricle RV to the right atrium RA.

[0003] See also Figure 2 , a normal healthy mitral valve or tricuspid valve has multiple tendon chordae L. Taking the mitral valve as an example, the mitral valve leaflets are divided into anterior leaflet and posterior leaflet. When the left ventricle is in diastole, both are in open state, and blood flows from the left atrium to the left ventricle; when the left ventricle is in contraction, the tendons are stretched to ensure that the leaflets will not be washed to the atrial side by the blood flow, and the anterior and posterior leaflets are well closed, thereby ensuring that blood flows from the left ventricle through the aortic valve to the aorta. If there is a lesion in the chordae tendineae or papillary muscles, such as Figure 3 The chordae tendineae of the posterior leaflet shown in the figure are ruptured. When the left ventricle is in a contracted state, the mitral valve cannot return to a closed state as in a normal state. The force of blood flow will further cause the valve leaflet to dislocate into the left atrium, causing blood reflux.

[0004] After the chordae tendineae are diseased or ruptured, they cannot repair themselves. Even if a few chordae tendineae are ruptured, the tension of other chordae tendineae may increase and new chordae tendineae may rupture. Currently, chordae tendineae lesions are usually treated by surgical implantation of sutures, or sutures are used to replace the chordae tendineae. Invasive thoracotomy techniques are required, and general anesthesia and moderate hypothermia extracorporeal circulation are used as auxiliary support. This type of surgical procedure has the disadvantages of complex surgical procedures, high surgical costs, high degree of patient trauma, high risk of complications, long hospitalization time, and painful recovery process for patients.

[0005] There is currently an instrument that implants sutures in a minimally invasive manner. The instrument clamps the leaflets with a distal clamp and a proximal clamp. During the process of capturing the leaflets, the clamping surface of the capturing clamp is at a specific design angle and cannot be adjusted, which makes capturing the leaflets difficult, the surgical operation is cumbersome, and the risk of surgical failure is high. Moreover, after the capturing clamp holds the leaflets, the clamp needs to be axially withdrawn to clamp the leaflets. At this time, as the leaflets beat, the capturing clamp is easily separated from the leaflets, resulting in difficulty in capturing. Furthermore, when the capturing clamp is withdrawn, it is in a "barbed hook shape", which leads to the risk of hooking the chordae and leaflets during the withdrawal process, affecting the surgical operation. Summary of the invention

[0006] The technical problem to be solved by the present application is to provide a valve repair device that changes the existing capture and puncture methods of the valve leaflets during suture implantation.

[0007] In order to achieve the above purpose, the implementation method of this application adopts the following technical solutions:

[0008] A valve repair device, comprising:

[0009] A leaflet capturing component, comprising a first clamping member, a second clamping member, a limiting member, and a transmission component, wherein the second clamping member can be opened relative to the first clamping member to form an angle, or closed to capture the leaflets of the valve, and the limiting member limits the captured leaflets between the first clamping member and the second clamping member through transmission of the transmission component; and

[0010] A suture implantation assembly, the suture implantation assembly includes a puncture needle and a suture accommodated in the puncture needle and capable of being pushed; the first clamping member is provided with a guide groove; after the leaflet capturing assembly captures and clamps the leaflet, the puncture needle passes through the guide groove and punctures the leaflet, and the suture is pushed out of the puncture needle to the other side of the leaflet.

[0011] In a preferred embodiment, the surfaces facing each other of the first clamping member and the second clamping member are both provided with a clamping area and a non-clamping area, and the clamping area of ​​at least one of the first clamping member and the second clamping member is provided with clamping teeth to provide clamping force to the leaflet; when the first clamping member and the second clamping member are relatively closed, there is a gap between the non-clamping areas of the first clamping member and the second clamping member to accommodate a part of the leaflet that is not clamped; and the guide groove is connected to the non-clamping area of ​​the first clamping member.

[0012] In a preferred embodiment, the first clamping member and the second clamping member are respectively provided with connecting parts, the connecting parts are located on the side of the clamping area away from the non-clamping area, the connecting part of the second clamping member is hinged on the connecting part of the first clamping member, and one end of the transmission assembly is connected to the connecting part of the second clamping member to drive the second clamping member to open and close relative to the first clamping member.

[0013] In a preferred embodiment, a transmission channel is provided in the first clamping member, the transmission channel is communicated with the clamping area of ​​the first clamping member and extends to the connecting portion, the transmission assembly includes a transmission shaft and a transmission connecting member, the transmission shaft is movably received in the transmission channel and extends through the connecting portion, one end of the transmission connecting member is pivotally connected to the second clamping member through a first hinge shaft, and the other end of the transmission connecting member is pivotally connected to an end of the transmission shaft exposed from the connecting portion through a second hinge shaft.

[0014] In a preferred embodiment, the first clamping member is a block-shaped base, the second clamping member is a sheet-shaped cover, the connecting portion of the second clamping member has two ribs that are relatively spaced apart, one end of the two ribs away from the clamping area is hinged to the two sides of the connecting portion of the first clamping member through a rotating shaft, and one end of the two ribs close to the clamping area is pivotally connected to the transmission connecting member through the first hinge shaft.

[0015] In a preferred embodiment, the clamping areas of the first clamping member and the second clamping member are provided with a plurality of clamping teeth that match each other, the transmission channel forms an opening in the clamping area of ​​the first clamping member, the clamping area of ​​the first clamping member includes a first clamping tooth area and a second clamping tooth area located at two opposite sides of the opening, the clamping teeth of the first clamping member are located in the first clamping tooth area and the second clamping tooth area, and the clamping teeth of the second clamping member extend from one side of the clamping area to the other side.

[0016] In a preferred embodiment, convex parts are respectively arranged between the first clamping tooth area, the second clamping tooth area and the connecting part, the height of the convex parts is higher than the height of the clamping teeth, and a groove adapted to the convex part is arranged between the clamping area and the connecting part of the second clamping member.

[0017] In a preferred embodiment, a limiting member accommodating groove spanning the opening is formed between the first clamping tooth area and the second clamping tooth area, the first clamping member is provided with a traction line channel, the limiting member is accommodated in the limiting member accommodating groove, one end of the limiting member is fixed to the connecting portion of the first clamping member, and the other end is controlled by the traction line passing through the traction line channel.

[0018] In a preferred embodiment, the limiting member is provided with an opening corresponding to the opening, the opening extends to one end of the limiting member fixed to the first clamping portion, the limiting member accommodating groove is lower than the first clamping tooth area and the second clamping tooth area, and the limiting member is provided with an anchor member facing the second clamping member at a position corresponding to the clamping area, and the end of the anchor member is basically flush with the end of the clamping tooth of the first clamping member.

[0019] In a preferred embodiment, the limiting member is hinged at one end of the first clamping portion and has a pre-shaped section so that when the traction line is relaxed, the limiting member tends to be oriented toward the second clamping member, and the opening divides the pre-shaped section into a first arm and a second arm, and the first arm and the second arm are elastic so that when the traction line is tensioned, the limiting member is flatly accommodated in the limiting member accommodating groove.

[0020] In a preferred embodiment, the unopened end of the limiting member is provided with two traction wire through-holes, the traction wire passes through the traction wire through-holes, and both ends of the traction wire are located on the side where the anchor member is located, and both ends of the traction wire extend to the traction wire channel.

[0021] In a preferred embodiment, the non-clamping areas of the first clamping member and the second clamping member are respectively inclined relative to the clamping area, and the non-clamping areas of the first clamping member and the second clamping member are parallel to each other, and the non-clamping area of ​​the second clamping member is provided with a limiting groove penetrating the second clamping member and open at one end toward the end direction, the limiting groove is aligned with the guide groove, the puncture needle punctures the leaflet in the limiting groove, and the puncture angle is between 45-90 degrees.

[0022] In a preferred embodiment, an open groove is formed on a surface of the first clamping member facing away from the second clamping member, and the open groove is used to observe the connection state between the transmission shaft and the transmission connecting member.

[0023] In a preferred embodiment, the end of the first clamping member away from the second clamping member has a cylindrical end and a connector, the non-clamping area of ​​the first clamping member is formed on the side of the cylindrical end facing the second clamping member, and the connector is formed on the other side of the cylindrical end, when the second clamping member is closed relative to the first clamping member, the apex of the cylindrical end is higher than the apex of the second clamping member, the guide groove, the transmission channel and the imaging channel extend from the connector through the cylindrical end to the side of the non-clamping area, the guide groove is in an open state at the connector, and the connector is used to connect a delivery catheter.

[0024] The valve repair device provided by the present invention has the following beneficial effects:

[0025] One of the clamping members of the leaflet capture assembly of the valve repair device can be opened relative to the other to form an angle or closed to clamp the leaflet between the two. The relative opening angle of the two clamping members can be controlled and adjusted, and when the clamping position is not appropriate, the two can be reopened and closed relative to each other; the restriction of the restriction member makes the clamping more stable; the suture can be implanted as an artificial chordae to the other side of the leaflet, and can also be used as a suture for repairing the valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 This is a schematic diagram of the mitral valve and tricuspid valve in normal state;

[0027] Figure 2 is a schematic diagram of normal chordae tendineae in the heart;

[0028] Figure 3 is a schematic diagram of a ruptured chordae tendineae in the heart;

[0029] Figure 4 is a partial schematic diagram of a valve repair device provided by an embodiment of the present invention;

[0030] Figure 5 yes Figure 4 A three-dimensional schematic diagram of the second clamping member of the leaflet capture assembly of the valve repair device being opened relative to the first clamping member;

[0031] Figure 6 yes Figure 5 An exploded schematic diagram of a valve repair device;

[0032] Figure 7 yes Figure 6 An enlarged schematic diagram of the first clamping member in FIG.

[0033] Figure 8 yes Figure 7 A cross-sectional view of the first clamping member along the central axis;

[0034] Fig. 9 yes Figure 6 An enlarged schematic diagram of the second clamping member in FIG.

[0035] Fig.10 yes Figure 6 An enlarged schematic diagram of the transmission assembly in FIG.

[0036] Fig.11 yes Fig.10 A schematic diagram of the connection between the transmission assembly and the second clamping member;

[0037] Fig.12 yes Figure 6 An enlarged schematic diagram of the restriction member in FIG.

[0038] Fig.13 yes Fig.12 A schematic diagram of assembling the limiting member and the first clamping member;

[0039] Fig.14 yes Fig.13 The limiting member is further assembled with the second clamping member and the transmission assembly to form a schematic diagram of a leaflet capture assembly;

[0040] Fig.15 yes Fig.14A partial cross-sectional schematic diagram of the valve leaflet capture assembly and the delivery catheter after the traction line of the restriction member passes through the delivery catheter and the traction line is not tensioned;

[0041] Fig.16 yes Fig.15 A partial cross-sectional schematic diagram of a leaflet capture assembly when a traction line of the restriction member is tensioned;

[0042] Fig.17 It is a partial schematic diagram of the second clamping member of the leaflet capturing assembly of the valve repair device provided by an embodiment of the present invention when it is closed relative to the first clamping member;

[0043] Fig.18 yes Figure 4 A schematic top view of a valve repair device;

[0044] Fig.19 yes Figure 7 A schematic diagram of the first clamping member from another angle;

[0045] Fig. 20 yes Figure 4 A schematic diagram of a delivery catheter for a valve repair device;

[0046] Fig.21 yes Figure 4 A schematic diagram of a valve repair device including an operating handle;

[0047] Fig. 22 yes Fig.21 A partial cross-sectional view of a valve repair device at the operating handle;

[0048] Fig.23 yes Fig.21 A schematic diagram of a valve repair device after removing the housing, operating button and suture implantation assembly from the operating handle;

[0049] Fig.24 yes Fig.23 A partial cross-sectional view showing a puncture needle of a valve repair device further extending to a valve leaflet capture component;

[0050] Fig.25 It is a schematic diagram of a state in which the valve repair device provided by an embodiment of the present invention is loaded with a first bending adjustment sheath and a second bending adjustment sheath to deliver a valve leaflet capture component to heart tissue;

[0051] Fig.26 yes Fig.25 A schematic diagram of a state in which the second clamping member of the leaflet capturing assembly of the valve repair device is opened relative to the first clamping member to form a clamping angle;

[0052] Fig. 27 yes Fig.26 A schematic diagram of a state in which a leaflet capturing component of a valve repair device is aligned with the leaflet and received in the leaflet;

[0053] Fig.28 yes Fig. 27 A schematic diagram of a state in which a limiting member of a leaflet capturing assembly of a valve repair device clamps a leaflet;

[0054] Fig.29 yes Fig.28 A schematic diagram of a state in which a leaflet capturing component of a valve repair device clamps a leaflet;

[0055] Fig.30 yes Fig. 27 An enlarged schematic diagram of the valve repair device when the valve leaflets initially fall between the valve leaflet capture components;

[0056] Fig.31 yes Fig.30 An enlarged schematic diagram of a valve repair device clamping a valve leaflet with a restriction member;

[0057] Fig.32 yes Fig.31 An enlarged schematic diagram of the valve repair device puncturing the valve leaflet after the valve leaflet capture component is closed. DETAILED DESCRIPTION

[0058] In order to make the objectives, technical solutions and advantages of the present application clearer, the present application will be further described in detail below in conjunction with the accompanying drawings.

[0059] It should be understood that expressions such as "including" and "may include" that may be used in the present application indicate the existence of the disclosed functions, operations, or constituent elements, and do not limit one or more additional functions, operations, and constituent elements. In the present disclosure, terms such as "including" and / or "having" may be interpreted as indicating specific characteristics, numbers, operations, constituent elements, components, or combinations thereof, but may not be interpreted as excluding the existence or possibility of adding one or more other characteristics, numbers, operations, constituent elements, components, or combinations thereof.

[0060] In addition, in the present application, the expression "and / or" includes any and all combinations of the associated listed words. For example, the expression "A and / or B" may include A, may include B, or may include both A and B.

[0061] In the present application, expressions including ordinal numbers such as "first" and "second" can modify various elements. However, such elements are not limited by the above expressions. For example, the above expressions do not limit the order and / or importance of the elements. The above expressions are only used to distinguish one element from other elements. Similarly, without departing from the scope of the present disclosure, the first element can be referred to as the second element, and similarly, the second element can also be referred to as the first element.

[0062] When a component is referred to as being "connected" or "accessed" to another component, it should be understood that the component is not only directly connected to or accessed to the other component, but also another component may exist between the component and the other component. On the other hand, when a component is referred to as being "directly connected" or "directly accessed" to another component, it should be understood that there is no component between them.

[0063] In the field of interventional medical device technology, the direction close to the operator is generally defined as the proximal end, and the direction away from the operator is defined as the distal end. The direction of the rotation center axis of an object such as a cylinder or a tube is defined as the axial direction. The circumferential direction is the direction around the axis of an object such as a cylinder or a tube (perpendicular to the axis and also perpendicular to the cross-sectional radius).

[0064] See also Figure 4 and Figure 5 The valve repair device 100 provided in one embodiment of the present application includes a leaflet capture component 10 and a suture implantation component 20. The leaflet capture component 10 includes a first clamp 11, a second clamp 12, a transmission component 13 and a limiting component 14. Through the transmission of the transmission component 13, the second clamp 12 can be opened to a certain angle relative to the first clamp 11, or closed to capture and clamp the leaflet between the first clamp 11 and the second clamp 12.

[0065] In this embodiment, the first clamping member 11 is a block-shaped base, the second clamping member 12 is a sheet-shaped cover on the first clamping member 11, and one end of the first clamping member 11 is connected to the delivery conduit 16. The second clamping member 12 is hinged on the first clamping member 11, and the transmission assembly 13 is located between the first clamping member 11 and the second clamping member 12, and one end of the transmission assembly 13 is connected to the second clamping member 11, and the other end is movably transmitted in the first clamping member 11.

[0066] For details, please refer to Figures 6 to 9 The first clamping member 11 is provided with a connection portion 112, a clamping area 114 and a non-clamping area 116 from the far end away from the operator to the proximal end close to the operator; the second clamping member 12 is provided with a connection portion 122, a clamping area 124 and a non-clamping area 126 from the far end away from the operator to the proximal end close to the operator. The clamping area 114 of the first clamping member 11 faces the clamping area 124 of the second clamping member 12, and the non-clamping area 116 of the first clamping member 11 faces the non-clamping area 126 of the second clamping member 12, and when the first clamping member 11 and the second clamping member 12 are relatively closed, there is a gap between the non-clamping areas 126 of the first clamping member 11 and the second clamping member 12 (see Fig.17 ).

[0067] At least one of the clamping area 114 of the first clamping member 11 and the clamping area 116 of the second clamping member 12 is provided with clamping teeth to provide clamping force to the leaflets. In this embodiment, the clamping area 114 of the first clamping member 11 and the clamping area 124 of the second clamping member 12 are respectively provided with clamping teeth, and there is a tooth groove between two adjacent clamping teeth. When the first clamping member 11 and the second clamping member 12 are relatively closed, the clamping teeth 110 of the first clamping member 11 are meshed with the tooth groove 121 of the second clamping member 12, and the tooth groove 111 of the first clamping member 11 is meshed with the clamping teeth 120 of the second clamping member 12.

[0068] In this embodiment, the clamping teeth 110 of the first clamping member 11 are located at two opposite sides of the clamping area 114, forming a first clamping tooth area 114a and a second clamping tooth area 114b spaced apart from each other. The clamping teeth 120 of the second clamping member 12 are arranged side by side transversely along the surface of the clamping area 124, and extend from one side of the clamping area to the other side.

[0069] The connecting portion 122 of the second clamping member 12 has two ribs 122a arranged at intervals. The connecting portion 112 of the first clamping member 11 is block-shaped. The two ribs 122a have an end away from the clamping area 124 and an axial hole 122c. Then, the ribs 122a are hinged to the axial holes 112a on both sides of the connecting portion 112 of the first clamping member 11 through a rotating shaft 11b, so that the second clamping member 12 can be rotated relative to the first clamping member 11 to be relatively opened or closed. The two ribs 122a have a certain inclination toward the first clamping member 11 relative to the clamping area 124. The two side edges of the connecting portion 112 of the first clamping member 11 have inclined supporting portions 112b respectively. When the first clamping member 11 and the second clamping member 12 do not clamp the leaflets and are relatively closed, the two ribs 122a are just accommodated on the supporting portions 112b, so that the entire leaflet capturing assembly 10 has a smaller size.

[0070] The first clamping member 11 is provided with a transmission channel 115 from the proximal end to the distal end. The transmission channel 115 is communicated with the clamping area 114 and has an opening in the clamping area 114 , and the opening extends to the connecting portion 112 .

[0071] Please also read Figure 6 , Fig.10 and Fig.11The transmission assembly 13 includes a transmission shaft 132 and a transmission connector 134. The transmission shaft 132 is movably received in the transmission channel 115. Specifically, its first end 132b is located in the transmission channel 115 of the first clamping member 11, and the opposite second end 132a extends out of the distal end of the first clamping member 11. The first end 132b is used to be threadedly connected to a drive shaft 136 extending into the transmission channel 115 of the first clamping member 11 (see Fig.24 ), the drive shaft 136 further extends to the operating handle (see Fig.21 The second end 132a is inserted into the fixing hole 135a of the base 135 for fixing. The surface of the first clamping member 11 facing away from the second clamping member 12 is provided with an open groove 130 (see Figure 8 and Fig.24 ), the open slot 130 is used to observe the connection status between the transmission shaft 132 and the drive shaft 136, including whether they are connected in place and whether there are any abnormal conditions.

[0072] The base 135 also has an axial hole 135c for connecting the transmission connecting member 134. The first end of the transmission connecting member 134 is hinged to the second clamping member 12 on the hinge shaft 134b. Since the connecting portion 122 of the second clamping member 12 is two ribs 122a arranged relatively spaced apart, the first end of the transmission connecting member 134 is provided with a connecting column 134a, and the connecting column 134a has an axial hole 134d inside, which is hinged to the axial holes 122b at the ends of the two ribs 122a near the clamping area 124 through the first hinge shaft 134b. The second end opposite to the transmission connecting member 134 has two spaced axial holes 134c, and the axial hole 135c of the base 135 is placed between the two axial holes 134c. After the axial hole 135c of the base 135 is sleeved on the second hinge shaft 135b, the two axial holes 134 of the transmission connecting member 134 are hinged on the second hinge shaft 135b. The first hinge shaft 134b and the second hinge shaft 135b may both be pins.

[0073] The hinge described in the embodiment of the present application is a movable connection, and the hinge can be a connection between two parts with a certain degree of freedom, and one of the parts can be rotatable. The base 135 in the embodiment of the present application is fixed to the end of the transmission shaft 132, and is driven by the drive shaft 136 together with the transmission shaft 132. When the drive shaft 136 pulls the transmission shaft 132 and the base 135 to move axially, for example, in the proximal direction, the transmission connection 134 will rotate outward around the base 135, and due to the pulling of the transmission connection 134 and the hinge connection between the second clamping member 12 and the rotating shaft 11b, the second clamping member 12 will rotate around the rotating shaft 11b, so that the second clamping member 12 opens relative to the first clamping member 11; when the drive shaft 136 pulls the transmission shaft 132 and the base 135 to move in the distal direction, the transmission connection 134 will rotate inward around the base 135, and push the second clamping member 12 to rotate inward, so that the second clamping member 12 closes relative to the first clamping member 11, so that the relative opening and closing between the second clamping member 12 and the first clamping member 11 can be achieved, and the transmission component 13 also becomes the opening and closing control element of the leaflet capture component 10.

[0074] See also Figure 6-8 as well as Figure 12-14 A limiting member accommodating groove 113 is formed between the first clamping tooth area 114a and the second clamping tooth area 114b of the first clamping member 11. The limiting member accommodating groove 113 is lower than the first clamping tooth area 114a and the second clamping tooth area 114b, and spans the opening of the transmission channel 115 in the clamping area 114. Preferably, the limiting member accommodating groove 113 is symmetrically located on both sides of the opening of the transmission channel 115 in the clamping area 114.

[0075] The limiting member receiving groove 113 is used to receive the limiting member 14. The limiting member 14 is made of an integral elastic material, and an opening 14a is provided in the middle of the limiting member 14, and the opening 14a extends to one end of the limiting member 14, so that the limiting member 14 is formed in a form with one end open and the other end not open, and the open end forms two spaced-apart first arms 141 and second arms 142. The unopened end of the limiting member 14 has two traction wire through holes 144, and the first clamping member 11 is provided with two traction wire channels 15a. One end of the traction wire 15 passes through one of the traction wire through holes 144 of the limiting member 14 from the side of the limiting member 14 facing the second clamping member 12 to reach the other side of the limiting member 14 away from the second clamping member 12, and then extends along the other side to the other traction wire through hole 144, and passes through the other traction wire through hole 144 so that the two ends of the traction wire 15 are located on the same side of the limiting member 14 facing the second clamping member 12, and then the two ends of the traction wire 15 are extended to the operating handle through the traction wire channel 15a (see Fig.21 ).

[0076] The pulling wire 15b is not limited to the above threading method, and both ends of the pulling wire 15b can be simultaneously passed from the other side of the limiting member 14 away from the second clamping member 12 to the side of the limiting member 14 facing the second clamping member 12, so that both ends of the pulling wire 15 are located on the same side of the limiting member 14 facing the second clamping member 12, and the side of the limiting member 14 facing the second clamping member 12 is the clamping side of the limiting member 14. The two ends of the pulling wire 15 are located on the same side of the limiting member 14 facing the second clamping member 12, so that the limiting member 14 can be maximally compactly attached to the first clamping member 11 when the pulling wire 15 is tightened.

[0077] The ends of the first arm 141 and the second arm 142 are respectively provided with an axial hole 143, and the axial hole 143 is fixed to the fixing hole 112c of the connecting portion 112 of the first clamping member 11 through a pin 14b. The first arm 141 and the second arm 142 have a pre-shaped section near the end, please refer to Fig.14 and Fig.15 The shaping section makes the traction line 15 in a relaxed state when the limiting member 14 is not pulled by the traction line 15 (see Fig.15 ), the limiting member 14 has a tendency to move toward the second clamping member 12. Since the limiting member 14 is made of elastic material and the opening 14a makes the first arm 141 and the second arm 142 more elastic, when the traction force of the traction line 15 is tightened (see Fig.16 ), the limiting member 14 can be flatly accommodated in the limiting member accommodating groove 113, and at this time, the unopened end of the limiting member 14 closes the partial transmission channel 115.

[0078] The first arm 141 and the second arm 142 are respectively provided with anchor members 145 facing the second clamping member 12 from the unopened end to the opened end of the limiting member 14. The height of the anchor member 145 protruding from the surface of the limiting member 14 is such that the end of the anchor member 145 is basically flush with the end of the clamping tooth 110 of the first clamping member 11, so that the anchor member 145 will not be too long to hook the leaflet and the chordae tendineae.

[0079] In the leaflet capture assembly 10 of this embodiment, in addition to the clamping teeth of the first clamping member 11 and the second clamping member 12 cooperating to clamp the leaflet, the limiting member 14 also forms a certain clamping with the second clamping member 12 using the anchoring member 145 between the first clamping tooth area 114a and the second clamping tooth area 114b, thereby playing the role of limiting the leaflet and making the clamping more stable.

[0080] Please refer again Figure 7 , Fig. 9 , Fig.13 and Fig.16, a convex part 119 is provided between the clamping area 114 and the connecting part 112 of the first clamping member 11, and the height of the convex part 119 is higher than the height of the clamping teeth 110, and a groove 125 is provided between the clamping area 124 and the connecting part 122 of the second clamping member 12. In this embodiment, the convex part 119 and the groove 125 are respectively provided with two, and the two convex parts 119 are respectively located between the first clamping tooth area 114a and the second clamping tooth area 114b and the connecting part 112, and the convex part 119 is adjacent to the clamping teeth 110. When the first clamping member 11 and the second clamping member 12 do not clamp the leaflet and are relatively closed, the convex part 119 is received in the groove 125. When there are leaflets between the convex part 119 and the groove 125, the first clamping member 11 and the second clamping member 12 cannot be completely closed. In this way, the convex part 119 can be used as a detection mark to detect whether the leaflets are clamped in the appropriate position. For example, when it is found that the first clamping member 11 and the second clamping member 12 cannot be closed, it may be because too many leaflets are accumulated between the convex part 119 and the groove 125. At this time, the first clamping member 11 and the second clamping member 12 of the leaflet capture component 10 can be reopened so that the leaflets fall mainly between the clamping area 114 of the first clamping member 11 and the clamping area 124 of the second clamping member 12. The situation that too many leaflets are accumulated between the convex part 119 and the groove 125 can also be observed through medical images of the surgical process. The height of the convex part 119 is higher than the height of the clamping teeth 110, so it is recognizable under medical images. The depth of the groove 125 can be smaller than the sum of the thickness of the convex part 119 and the leaflets. In this way, when leaflets are accumulated between the convex part 119 and the groove 125, the convex part 119 cannot be completely accommodated in the groove 125, that is, the first clamping member 11 and the second clamping member 12 cannot be completely closed when closed.

[0081] The convex part 119 is preferably a trihedron or a tetrahedron so as to have better recognition under medical images. Of course, it can also be a cylindrical shape, and the positions of the convex part 119 and the groove 125 can also be interchanged.

[0082] Please also read Fig.16 and Fig.17 , the non-clamping area 116 of the first clamping member 11 is an inclined surface as a whole, which is inclined from the clamping area 114 to the proximal direction; the non-clamping area 126 of the second clamping member 12 is also an inclined surface as a whole, which is inclined from the clamping area 124 to the proximal direction, and the non-clamping area 116 of the first clamping member 11 is oriented toward and parallel to the non-clamping area 126 of the second clamping member 12. In other embodiments, the non-clamping area 116 and the non-clamping area 126 may also be partially inclined and parallel.

[0083] The length L31 of the clamping area 114 of the first clamping member 11 from the distal end to the proximal end and the length L32 of the clamping area 124 of the second clamping member 12 from the distal end to the proximal end are respectively between 3-5 mm, and the length L31 of the clamping area 114 and the length L32 of the clamping area 124 can be equal or unequal. The length L11 of the non-clamping area 116 of the first clamping member 11 from the distal end to the proximal end and the length L12 of the non-clamping area 126 of the second clamping member 12 from the distal end to the proximal end are respectively between 2-5 mm. The length L12 of the non-clamping area 126 can be slightly larger than the length L11 of the non-clamping area 116, so that when the second clamping member 12 is closed on the surface of the first clamping member 11, the top of the non-clamping area 126 is higher than the top of the non-clamping area 116. The gap L2 between the non-clamping area 116 of the first clamping member 11 and the non-clamping area 126 of the second clamping member 12, that is, the gap L2 between the inclined surfaces is between 0.5-2 mm to accommodate the thickness of the heart valve leaflet.

[0084] The first clamping member 11 and the second clamping member 12 have a clamping force on the leaflets when closed. The clamping teeth 110 of the first clamping member 11, the clamping teeth 120 of the second clamping member 12 and the limiting member 14 make the clamping more stable. The non-clamping area 116 of the first clamping member 11 and the non-clamping area 126 of the second clamping member 12 have no clamping force on the leaflets, but have a certain supporting effect.

[0085] After the capture component 10 of the valve repair device 100 of the embodiment of the present invention captures the valve leaflet, the suture implantation component 20 implants sutures into the captured valve leaflet. The suture implantation component 20 punctures the valve leaflet with a puncture needle, and then pushes the suture from the inside of the puncture needle to the outside to reach the other side of the valve leaflet.

[0086] Please refer again Figure 7 , Fig. 9 and Fig.18, the non-clamping area 116 of the first clamping member 11 is provided with a guide groove 117, and the guide groove 117 has an opening in the non-clamping area 116. In this embodiment, the guide groove 117 is located above the non-clamping area 116, and the non-clamping area 126 of the second clamping member 12 is provided with a limiting groove 127 that penetrates the second clamping member 12 and is open at one end in the proximal direction, that is, the end direction of the second clamping member 12. When the second clamping member 12 and the first clamping member 11 are closed, the limiting groove 127 is lower than the guide groove 117 and is aligned with the guide groove 117, and the width or diameter D2 of the limiting groove 127 is greater than the diameter D1 of the puncture needle, so that the puncture needle can pass through the limiting groove 127, and the limiting groove 127 has a certain accommodation for the leaflet, so that the puncture needle is not easy to slip when puncturing the leaflet. The puncture needle has a certain needle tip, and the puncture point of the needle tip at the valve leaflet is optimally located at the middle point of the limiting groove 127, or two-thirds of the area of ​​the puncture needle is accommodated by the limiting groove 127 so that the needle tip can puncture the valve leaflet, so that the puncture needle will not slip and the puncture is stable.

[0087] Please refer again Figure 4 and Figure 8 , the non-clamping area 126 of the second clamping member 12 has an inclination angle A relative to the clamping area 124, and the non-clamping area 116 of the first clamping member 11 is parallel to the non-clamping area 126 of the second clamping member 12, so the non-clamping area 116 of the first clamping member 11 also has an inclination angle A relative to the clamping area 114. The guide groove 117 includes an inclination section 117a adjacent to the non-clamping area 116 of the first clamping member 11, and the inclination section 117a is inclined upward relative to the inclination starting point of the guide groove 117 in the first clamping member 11 to form an inclination angle B relative to the inclination starting point, and the inclination angle B makes the needle exit angle of the puncture needle appropriately raised. The angle C between the needle tip and the leaflet when the puncture needle punctures the leaflet satisfies C=A+B. Preferably, the inclination angle A of the non-clamping area 116 is between 45 and 70 degrees, the inclination angle B of the guide groove 117 is between 0 and 20 degrees, and the angle C of the puncture needle puncturing the leaflet is between 45 and 90 degrees. In this embodiment, the inclination angle A of the non-clamping area 116 is 70 degrees or close to 70 degrees, the inclination angle B of the guide groove 117 is 20 degrees or close to 20 degrees, and the angle C of the puncture needle puncturing the leaflet is 90 degrees or close to 90 degrees, that is, the puncture needle is in a state of puncturing the leaflet basically vertically, which helps to prevent the needle from slipping during puncture, and the needle will not slip and injure the leaflet, causing secondary damage to the leaflet.

[0088] See also Fig.19The end of the first clamping member 11 away from the second clamping member 12, that is, the proximal end of the first clamping member 11 has a connector 150, and the guide groove 117, the transmission channel 115 and the traction line channel 15a extend from the connector 150 to one side of the non-clamping area 116. The connector 150 is used to connect the delivery catheter 16 (see Fig. 20 ).

[0089] The proximal end of the first clamping member 11 has a cylindrical end 150a, and the non-clamping area 116 of the first clamping member 11 is formed on one side of the cylindrical end 150a facing the second clamping member 12, and the connector 150 is formed on the other side of the cylindrical end 150a. The top of the cylindrical end 150a is the highest point of the first clamping member 11. When the second clamping member 12 and the first clamping member 11 are closed, the top of the cylindrical end 150a is higher than the top of the second clamping member 12, which is beneficial during transportation, and the movable second clamping member 12 will not be hit by the transportation sheath. The connector 150 is recessed downward relative to the cylindrical end 150a to be used for sleeve-mounting the transportation catheter 16. After the transportation catheter 16 is sleeved with the connector 150, the transportation catheter 16 is substantially flush with the surface of the cylindrical end 150a. The guide groove 117, the transmission channel 115 and the traction line channel 15a extend from the connector 150 through the cylindrical end 150a to one side of the non-clamping area 116. The transmission channel 115 and the two traction line channels 15a are in the form of through holes in the connector 150, and the guide groove 117 is in the form of an incomplete arc opening at the connector 150. Since the guide groove 117 is bent upward at the inclined section 117a of the first clamping member 11, there may be more resistance when the puncture needle moves. Therefore, the open form of the connector 150 helps to reduce the resistance when the puncture needle moves.

[0090] See also Fig. 20 The delivery conduit 16 is made of polymer material and is slender and flexible. One end 165 of the delivery conduit 16 can cover the inwardly recessed portion of the connector 150 by hot melting. The delivery conduit 16 has a plurality of mutually spaced cavities, which correspond to the guide groove 117, the transmission channel 115 and the two traction line channels 15a connected to the first clamp 11. The transmission cavity 161 of the delivery conduit 16 corresponding to the transmission channel 115 is used to accommodate the drive shaft 136. The drive shaft 136 can be a metal rod, which passes through the delivery conduit 16 and is connected to the operating handle 18 (see Fig.21 ) The needle insertion cavity 162 of the corresponding guide groove 117 of the delivery catheter 16 is used to accommodate the puncture needle, and the puncture needle is also connected to the operating handle. The traction wire cavity 163 of the corresponding traction wire channel 15a of the delivery catheter 16 is used to pass the traction wire to the operating handle.

[0091] See also Fig. 22 The proximal end of the delivery catheter 16 away from the leaflet capture assembly 10 is connected to the operating handle 18. The operating handle 18 has a button 181 connected to the drive shaft 136. The housing 180 of the operating handle 18 can be provided with a slide groove for the button 181 to slide. By pressing and pushing the button 181, the drive shaft 136 can be driven to move axially, thereby driving the transmission shaft 132 to move axially. The movement of the transmission shaft 132 causes the hinged transmission connection 134 to pull or push the second clamping member 12 to open or close relative to the first clamping member 11. The operating handle 18 also has a limiting member control assembly 182, which can adjust the tension and relaxation of the traction line 15 of the limiting member 14, so as to control the clamping of the leaflet by the limiting member 14. The operating end of the suture implantation assembly 20 can be movably mounted at the end of the housing 180 of the operating handle 18.

[0092] Please also read Figure 22 to Figure 24 The suture implantation assembly 20 includes a puncture needle assembly 21 and a suture push assembly 22. The puncture needle assembly 21 includes a puncture needle push handle 211, a guide assembly 212 and a puncture needle 213. The puncture needle push handle 211 is movably accommodated in the housing 180 of the operating handle 18. The puncture needle 213 is fixedly connected to the puncture needle push handle 211. The guide assembly 212 includes a guide sleeve 212a and a guide shaft 212b. The guide sleeve 212a is fixedly connected to the puncture needle push handle 211. The guide shaft 212b is fixed in the housing 180 of the operating handle 18, and one end of the guide sleeve 212a is accommodated in the guide sleeve 212a. The inner diameter of the guide sleeve 212a is slightly larger than the outer diameter of the puncture needle 213, but it can support the puncture needle 213, so as to guide the puncture needle 213. When the puncture needle pushing handle 211 is pushed, the guide sleeve 212a moves axially along the outer diameter of the guide shaft 212b, and the puncture needle 213 is pushed along the inner diameter of the guide shaft 212b through the delivery catheter 16 to reach the guide groove 117 of the leaflet capture assembly 10.

[0093] The suture push assembly 22 includes a push handle 221, a push shaft 222 and a push catheter 223. The push handle 221 may be a ring. One end of the push shaft 222 is fixedly connected to the push handle 221, and the other end extends into the puncture needle push handle 211 and is fixedly connected to the push catheter 223. The push catheter 223 is movably accommodated in the puncture needle 213. The suture 225 may be loaded in the push catheter 223, and the suture 225 does not need to be fixed in the push catheter 223. The end of the suture 225 extends out of the push catheter 223 and is accommodated in the puncture needle 213. The suture 225 may be threaded on a gasket, which is placed at the end of the push catheter 223, and the end of the suture 225 may be knotted, so that it is convenient to be pushed out of the puncture needle 213 by the push catheter 223.

[0094] Please also read Figures 25 to 32 The delivery catheter 16 of the valve repair device 100 can be loaded in the bending sheath, and the bending sheath can include a first bending sheath 200 and a second bending sheath 200. The first bending sheath 200 and the second bending sheath 200 play a role in guiding and bending in the heart tissue during the delivery process of the valve repair device. The first bending sheath 200, the second bending sheath 200 and the valve repair device 100 can be operated independently in vitro, and the leaflet capture assembly 10 is delivered to the upper part of the heart leaflet 400 to be repaired under the observation of medical images. Then, the second clamping member of the leaflet capture assembly 10 is opened relative to the first clamping member. At this time, the operating handle of the valve repair device 100 can be fine-tuned to make the second clamping member be at an angle substantially perpendicular to the leaflet to align with the leaflet and receive the leaflet. At this time, the leaflet capture assembly 10 is closed to clamp the leaflet, and then the suture implantation assembly 20 can be operated to puncture the leaflet with the puncture needle 213, and the suture is pushed out to the other side of the leaflet.

[0095] After the suture implantation assembly 20 of the valve repair device 100 of the embodiment of the present invention pushes the suture to the other side of the valve leaflet, the suture can be fixed to the heart tissue by another device to play a suturing role, or the suture can directly replace the work of the native chordae tendineae of the heart, that is, it can be fixed to the papillary muscle as an artificial chordae tendineae. The material of the suture can be PTFE, e-PTFE, PET, UHMWPE, etc.

[0096] After the suture implantation of the valve repair device 100 according to the embodiment of the present invention is completed, the suture is left in the heart tissue, the puncture needle is withdrawn, and then the leaflet capture assembly 10 is withdrawn, so that the valve repair device 100 is separated from the heart tissue as a whole and withdrawn.

[0097] It is understandable that the above diagram only uses the puncture direction of the valve leaflet from the atrial side to the ventricular side when the suture is implanted as an example. The valve repair device of the present application can also be used to puncture the valve leaflet from the ventricular side to the atrial side, for example, using a delivery path through the right ventricle-ventricular septum-left ventricle-mitral valve, or a delivery path through the apex-left ventricle-mitral valve. Of course, the valve repair device of the present application can also be used for suture implantation of the tricuspid valve. Except for the difference in the path of the interventional surgery, the structure of the tricuspid valve repair device is the same as that of the mitral valve repair device, which will not be repeated here.

[0098] The above are only the preferred implementation modes of the present application, and are not intended to limit the present application in any form. Although the present application has been disclosed as above in terms of the preferred implementation modes, it is not intended to limit the present application. Any technician familiar with the art can use the methods and technical contents disclosed above to make many possible changes and modifications to the technical solutions of the present application, or modify them into equivalent implementation modes with equivalent changes, without departing from the scope of the technical solutions of the present application. Therefore, any simple modifications, equivalent changes and modifications made to the above implementation modes based on the technical essence of the present application, which do not depart from the contents of the technical solutions of the present application, are still within the scope of protection of the technical solutions of the present application.

Claims

1. A valve repair device, characterized in that: It includes: A leaflet capturing component, comprising a first clamping member, a second clamping member, a limiting member, and a transmission component, wherein the second clamping member can be opened relative to the first clamping member to form an angle, or closed to capture the leaflets of the valve, and the limiting member limits the captured leaflets between the first clamping member and the second clamping member through transmission of the transmission component; and A suture implantation assembly, the suture implantation assembly includes a puncture needle and a suture accommodated in the puncture needle and capable of being pushed; the first clamping member is provided with a guide groove; after the leaflet capturing assembly captures the leaflet, the puncture needle passes through the guide groove and punctures the leaflet, and the suture is pushed out of the puncture needle to the other side of the leaflet.

2. The valve repair device according to claim 1, characterized in that: The surfaces facing each other of the first clamping member and the second clamping member are both provided with a clamping area and a non-clamping area, the guide groove is connected with the non-clamping area of ​​the first clamping member, at least one of the clamping areas is provided with clamping teeth, and when the first clamping member and the second clamping member are relatively closed, there is a gap between the non-clamping areas of the first clamping member and the second clamping member to accommodate a part of the leaflet that is not clamped, and the gap is between 0.5-2mm.

3. The valve repair device according to claim 2, characterized in that: The first clamping member and the second clamping member are respectively provided with connecting parts, and the connecting parts are located on the side of the clamping area away from the non-clamping area. The connecting part of the second clamping member is hinged on the connecting part of the first clamping member, and one end of the transmission assembly is connected to the connecting part of the second clamping member to drive the second clamping member to open and close relative to the first clamping member.

4. The valve repair device according to claim 3, characterized in that: A transmission channel is provided in the first clamping member, the transmission channel is communicated with the clamping area of ​​the first clamping member and extends to the connecting portion, the transmission assembly includes a transmission shaft and a transmission connecting member, the transmission shaft is movably received in the transmission channel and extends through the connecting portion, one end of the transmission connecting member is hinged to the second clamping member through a first hinge shaft, and the other end of the transmission connecting member is hinged to an end of the transmission shaft exposed from the connecting portion through a second hinge shaft.

5. The valve repair device according to claim 4, characterized in that: The connecting portion of the second clamping member has two ribs that are relatively spaced apart, and one end of the two ribs away from the clamping area is hinged to the two sides of the connecting portion of the first clamping member through a rotating shaft, and one end of the two ribs close to the clamping area is pivotally connected to the transmission connecting member through the first hinge shaft.

6. The valve repair device according to claim 4, characterized in that: The clamping areas of the first clamping member and the second clamping member are provided with a plurality of clamping teeth that match each other, the transmission channel forms an opening in the clamping area of ​​the first clamping member, the clamping area of ​​the first clamping member includes a first clamping tooth area and a second clamping tooth area located at two opposite sides of the opening, the clamping teeth of the first clamping member are located in the first clamping tooth area and the second clamping tooth area, and the clamping teeth of the second clamping member extend from one side of the clamping area to the other side.

7. The valve repair device according to claim 6, characterized in that: Convex parts are respectively arranged between the first clamping tooth area, the second clamping tooth area and the connecting part, and the height of the convex parts is higher than the height of the clamping teeth. A groove adapted to the convex part is arranged between the clamping area and the connecting part of the second clamping member.

8. The valve repair device according to claim 6, characterized in that: A limiting member accommodating groove spanning the opening is formed between the first clamping tooth area and the second clamping tooth area. The first clamping member is provided with a traction line channel. The limiting member is accommodated in the limiting member accommodating groove, and one end is fixed to the connecting portion of the first clamping member, and the other end is controlled by the traction line passing through the traction line channel.

9. The valve repair device according to claim 8, characterized in that: The limiting member is provided with an opening corresponding to the opening, and the opening extends to one end of the limiting member fixed to the first clamping part, the limiting member accommodating groove is lower than the first clamping tooth area and the second clamping tooth area, and the limiting member is provided with an anchor member facing the second clamping member at a position corresponding to the clamping area, and the end of the anchor member is basically flush with the end of the clamping tooth of the first clamping member.

10. The valve repair device according to claim 9, characterized in that: The limiting member is hinged at one end of the first clamping portion and has a pre-shaped section so that the limiting member tends to move toward the second clamping member when the traction line is relaxed, and the opening divides the pre-shaped section into a first arm and a second arm, and the first arm and the second arm are elastic so that the limiting member is flatly accommodated in the limiting member accommodating groove when the traction line is tensioned.

11. The valve repair device according to claim 10, characterized in that: The unopened end of the restriction member is provided with two traction wire through-holes, the traction wire passes through the traction wire through-holes, and both ends of the traction wire are located on the side where the anchor member is located, and both ends of the traction wire extend to the traction wire channel.

12. The valve repair device according to claim 2, characterized in that: The non-clamping areas of the first clamping member and the second clamping member are respectively inclined relative to the clamping area, and the non-clamping areas of the first clamping member and the second clamping member are parallel to each other. The non-clamping area of ​​the second clamping member is provided with a limiting groove penetrating the second clamping member and open at one end toward the end direction. The limiting groove is aligned with the guide groove. The puncture needle punctures the leaflet in the limiting groove, and the puncture angle is between 45-90 degrees.

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