Valve repair devices

Abstract

The present application provides a valve repair device, which includes a leaflet capture component and a suture implantation component. The leaflet capture component includes a first clamp, a second clamp, a limiting component and a transmission component. Through the transmission of the transmission component, the second clamp can be opened relative to the first clamp to form an angle, or closed to capture the leaflets of the valve, and the limiting component limits the captured leaflets between the first clamp and the second clamp. The suture implantation component includes a puncture needle and a suture that can be pushed and accommodated in the puncture needle. The first clamp is provided with a guide groove. After the leaflet capture component 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.

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 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 blood from flowing from the right ventricle RV to the right atrium RA.

[0003] See Figure 2 A normal and healthy mitral or tricuspid valve has multiple chordae tendineae 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 chordae tendineae are stretched to ensure that the leaflets are not 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] Chordae tendineae cannot repair themselves after they become diseased or ruptured. Even if a few chordae rupture, the tension in other chordae can increase, leading to new ruptures. Currently, chordalopathy is typically treated with surgical suture implantation, or sutures are used to replace the chordae tendineae. This requires invasive thoracotomy, general anesthesia, and moderate hypothermia with extracorporeal circulation as support. This type of surgery has drawbacks such as a complex procedure, high surgical cost, high patient trauma, high risk of complications, long hospital stays, and a painful recovery process.

[0005] There is currently an instrument that implants sutures in a minimally invasive manner. The instrument clamps the leaflets with distal and proximal clamps. During the process of capturing the leaflets, the clamping surface of the capture 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 capture clamp supports the leaflets, the clamp needs to be axially retracted to clamp the leaflets. At this time, as the leaflets beat, the capture clamp and the leaflets are easily separated, making capture difficult. In addition, when the capture clamp is retracted, it is in a "hook shape", which leads to the risk of hooking the chordae tendineae and the leaflets during the retraction 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 objectives, the embodiments of the present application adopt the following technical solutions:

[0008] A valve repair device, comprising:

[0009] A leaflet capture assembly, comprising a first clamping member, a second clamping member, a limiting member, and a transmission assembly, 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 by the transmission assembly; and

[0010] A suture implantation assembly includes a puncture needle and a suture accommodated in the puncture needle that can be pushed. The first clamping member is provided with a guide groove. After the leaflet capture 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 facing surfaces 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; 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 a connecting portion, the connecting portion is located on the side of the clamping area away from the non-clamping area, the connecting portion of the second clamping member is hinged to the connecting portion of the first clamping member, and one end of the transmission assembly is connected to the connecting portion 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 the 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, and the connecting portion of the second clamping member has two ribs arranged 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.

[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 on 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 provided between the first clamping tooth area, the second clamping tooth area and the connecting portion, and the height of the convex parts is higher than the height of the clamping teeth, and a groove adapted to the convex part is provided between the clamping area and the connecting portion 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, 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.

[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 hinge of the limiting member at one end of the first clamping portion has a pre-shaped section so that the limiting member has a tendency 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 have elasticity so that the limiting member is flatly accommodated in the limiting member accommodating groove when the traction line is tensioned.

[0020] In a preferred embodiment, 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.

[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 areas of the second clamping member are 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 status of 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, and the guide groove, transmission channel and radiography 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 open relative to the other to form an angle or close 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 inappropriate, 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 and tricuspid valves in their 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 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] Figure 9 yes Figure 6 an enlarged schematic diagram of the second clamping member in FIG;

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

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

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

[0038] Figure 13 yes Figure 12 a schematic diagram of an assembly of the limiting member and the first clamping member;

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

[0040] Figure 15 yes Figure 14A partial cross-sectional schematic diagram of the valve leaflet capture assembly after being assembled with the delivery catheter, with the traction line of the restriction member passing through the delivery catheter and the traction line not being tensioned;

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

[0042] Figure 17 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] Figure 18 yes Figure 4 A schematic top view of a valve repair device;

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

[0045] Figure 20 yes Figure 4 Schematic diagram of a delivery catheter for a valve repair device;

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

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

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

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

[0050] Figure 25 This is a schematic diagram of a valve repair device provided by an embodiment of the present invention, wherein the first bending adjustment sheath and the second bending adjustment sheath are loaded to deliver the valve leaflet capture component to the heart tissue;

[0051] Figure 26 yes Figure 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] Figure 27 yes Figure 26 A schematic diagram of a valve leaflet capture component of a valve repair device aligning with and retracting the leaflet;

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

[0054] Figure 29 yes Figure 28 A schematic diagram of a valve leaflet capture component of a valve repair device clamping a valve leaflet;

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

[0056] Figure 31 yes Figure 30 An enlarged schematic diagram of the valve repair device clamping the valve leaflet at the restriction member;

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

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

[0059] It should be understood that expressions such as "including" and "may include" used in this 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 this 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 this 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 this application, expressions including ordinal numbers such as "first" and "second" may 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 this disclosure, a first element may be referred to as a second element, and similarly, a second element may be referred to as a 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 that 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 to" or "directly accessed" to another component, it should be understood that no component exists between them.

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

[0064] See also Figure 4 and Figure 5 A valve repair device 100 provided in one embodiment of the present application includes a leaflet capture assembly 10 and a suture implant assembly 20. The leaflet capture assembly 10 includes a first clamping member 11, a second clamping member 12, a transmission assembly 13, and a limiting member 14. Driven by the transmission assembly 13, the second clamping member 12 can open to a certain angle relative to the first clamping member 11, or close to capture and clamp the leaflet between the first clamping member 11 and the second clamping member 12.

[0065] In this embodiment, the first clamping member 11 is a block-shaped base, and the second clamping member 12 is a sheet-shaped member covering the first clamping member 11. One end of the first clamping member 11 is connected to the delivery conduit 16. The second clamping member 12 is hinged to the first clamping member 11. The transmission assembly 13 is located between the first clamping member 11 and the second clamping member 12. One end of the transmission assembly 13 is connected to the second clamping member 11, and the other end is movable and driven within the first clamping member 11.

[0066] For details, please refer to Figures 6 to 9 The first clamping member 11 is provided with a connecting portion 112, a clamping area 114, and a non-clamping area 116 from the distal end away from the operator to the proximal end close to the operator; the second clamping member 12 is provided with a connecting portion 122, a clamping area 124, and a non-clamping area 126 from the distal 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. 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 Figure 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 a clamping force on the leaflet. 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 each provided with clamping teeth, and a tooth groove is formed 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 engage with the tooth groove 121 of the second clamping member 12, and the tooth groove 111 of the first clamping member 11 engages 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 on 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 laterally along the surface of the clamping area 124, extending from one side of the clamping area to the other.

[0069] The connecting portion 122 of the second clamping member 12 has two ribs 122a spaced apart from each other. The connecting portion 112 of the first clamping member 11 is block-shaped. The two ribs 122a have axial holes 122c at one end away from the clamping area 124. The ribs 122a are hinged to the axial holes 112a on both sides of the connecting portion 112 of the first clamping member 11 via a rotating shaft 11b. In this way, the second clamping member 12 can rotate relative to the first clamping member 11 to open or close. The two ribs 122a are inclined relative to the clamping area 124 toward the first clamping member 11. The two side edges of the connecting portion 112 of the first clamping member 11 have inclined support portions 112b. When the first and second clamping members 11 and 12 are not clamping the leaflets and are relatively closed, the two ribs 122a are precisely accommodated on the support portions 112b, making the entire leaflet capture assembly 10 smaller in size.

[0070] The first clamping member 11 defines a transmission channel 115 extending from the proximal end to the distal end. The transmission channel 115 communicates with the clamping region 114 and has an opening in the clamping region 114 , which extends to the connecting portion 112 .

[0071] Please also refer to Figure 6 、 Figure 10 and Figure 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 Figure 24 ), the drive shaft 136 further extends to the operating handle (see Figure 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 Figure 24 ), the open slot 130 is used to observe the connection status of the transmission shaft 132 and the drive shaft 136, including whether they are connected in place and whether there are any abnormalities.

[0072] The base 135 also has an axial hole 135c for connecting to the transmission connector 134. The first end of the transmission connector 134 is hinged to the second clamping member 12 on a hinge axis 134b. Because the connecting portion 122 of the second clamping member 12 is composed of two ribs 122a spaced apart from each other, the first end of the transmission connector 134 is provided with a connecting column 134a. The connecting column 134a defines an axial hole 134d therein. The connecting column 134a is hingedly connected to the axial holes 122b at the ends of the two ribs 122a near the clamping area 124 via a first hinge axis 134b. The second, opposite end of the transmission connector 134 has two spaced axial holes 134c. The axial hole 135c of the base 135 is positioned between the two axial holes 134c. After the axial hole 135c of the base 135 is inserted onto the second hinge axis 135b, the two axial holes 134 of the transmission connector 134 are hinged to the second hinge axis 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. A hinge can be a connection between two parts with a certain degree of freedom. It can be a hinge in which one of the parts is rotatable. In the embodiment of the present application, the base 135 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 together with the base 135 to move axially, for example, when moving 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 together with 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 second clamping member 12 and the first clamping member 11 can be opened and closed relative to each other, so that 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 a one-piece elastic material. An opening 14a is provided in the middle of the limiting member 14. The opening 14a extends to one end of the limiting member 14, so that the limiting member 14 is open at one end and closed at the other end. 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 facing the second clamping member 12 to 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 extend to the operating handle through the traction wire channel 15a (see FIG. Figure 21 ).

[0076] The pulling wire 15b is not limited to the above-described threading method. Alternatively, both ends of the pulling wire 15b may be threaded simultaneously from the other side of the restricting member 14 facing away from the second clamping member 12 to the side of the restricting 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 restricting member 14 facing the second clamping member 12. The side of the restricting member 14 facing the second clamping member 12 is the clamping side of the restricting member 14. Having both ends of the pulling wire 15 located on the same side of the restricting member 14 facing the second clamping member 12 allows the restricting member 14 to be maximally adhered to the first clamping member 11 when the pulling wire 15 is tensioned.

[0077] The ends of the first arm 141 and the second arm 142 are respectively provided with an axis hole 143, which 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 Figure 14 and Figure 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 Figure 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 Figure 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 anchoring members 145 facing the second clamping member 12 from the unopened end to the open end of the limiting member 14. The height of the anchoring member 145 protruding from the surface of the limiting member 14 is such that the end of the anchoring member 145 is basically flush with the end of the clamping tooth 110 of the first clamping member 11, so that the anchoring 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 anchor 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 、 Figure 9 、 Figure 13 and Figure 16A convex component 119 protrudes between the clamping area 114 and the connecting portion 112 of the first clamping member 11. The height of the convex component 119 is higher than the height of the clamping teeth 110. A groove 125 is provided between the clamping area 124 and the connecting portion 122 of the second clamping member 12. In this embodiment, two convex components 119 and two grooves 125 are provided. The two convex components 119 are respectively located between the first clamping tooth area 114a and the second clamping tooth area 114b and the connecting portion 112, and the convex components 119 are adjacent to the clamping teeth 110. When the first clamping member 11 and the second clamping member 12 are not clamping the leaflet and are relatively closed, the convex component 119 is received in the groove 125. When leaflets are present between the convex component 119 and the groove 125, the first clamping member 11 and the second clamping member 12 cannot completely close. Thus, the convex component 119 can be used as a detection mark to detect whether the leaflets are clamped in the proper position. For example, if the first clamping member 11 and the second clamping member 12 cannot close, it may be due to excessive leaflets being accumulated between the convex component 119 and the groove 125. In this case, the first clamping member 11 and the second clamping member 12 of the leaflet capture assembly 10 can be reopened, allowing the leaflets to fall primarily between the clamping area 114 of the first clamping member 11 and the clamping area 124 of the second clamping member 12. The accumulation of excessive leaflets between the convex component 119 and the groove 125 can also be observed through medical imaging of the surgical procedure. The height of the convex component 119 is higher than that of the clamping teeth 110, making it easily recognizable in medical imaging. The depth of the groove 125 can be less than the sum of the thickness of the convex part 119 and the leaflet. In this way, when the 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 part 11 and the second clamping part 12 cannot be completely closed when closed.

[0081] The convex component 119 is preferably a trihedron or a tetrahedron for better recognition under medical imaging. Of course, it can also be a cylindrical shape, etc. The positions of the convex component 119 and the groove 125 can also be interchanged.

[0082] Please also refer to Figure 16 and Figure 17 The non-clamping area 116 of the first clamping member 11 is formed as a whole into an inclined surface, sloping from the clamping area 114 toward the proximal end; the non-clamping area 126 of the second clamping member 12 is also formed as a whole into an inclined surface, sloping from the clamping area 124 toward the proximal end, 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 areas 116 and 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. 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] When the first clamping member 11 and the second clamping member 12 are closed, they have a clamping force on the leaflet. The clamping teeth 110 of the first clamping member 11 and the clamping teeth 120 of the second clamping member 12 as well as 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 leaflet, but have a certain supporting effect.

[0085] After the capture assembly 10 of the valve repair device 100 of the embodiment of the present invention captures the valve leaflet, the suture implantation assembly 20 implants sutures into the captured valve leaflet. The suture implantation assembly 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 、 Figure 9 and Figure 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, in the distal 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 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. The limiting groove 127 has a certain capacity 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 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 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. 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 inclined section 117a adjacent to the non-clamping area 116 of the first clamping member 11. The inclined section 117a is inclined upward relative to the starting point of the guide groove 117 within the first clamping member 11, forming an inclination angle B relative to the starting point. This inclination angle B appropriately raises the needle exit angle of the puncture needle. When the puncture needle punctures the leaflet, the angle C between the needle tip and 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 at which the puncture needle punctures 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 at which the puncture needle punctures the leaflet is 90 degrees or close to 90 degrees, that is, the puncture needle is in a state of substantially vertically puncturing the leaflet, which helps prevent the needle from slipping during puncture and prevents the needle from slipping and injuring the leaflet, causing secondary damage to the leaflet.

[0088] See also Figure 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 Figure 20 ).

[0089] The proximal end of the first clamping member 11 has a cylindrical end 150a. The non-clamping area 116 of the first clamping member 11 is formed on the 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. This is beneficial for preventing the movable second clamping member 12 from being hit by the delivery sheath during delivery. The connector 150 is recessed downward relative to the cylindrical end 150a for being used to be sleeved onto the delivery catheter 16. After the delivery catheter 16 is sleeved onto the connector 150, the delivery catheter 16 is substantially flush with the surface of the cylindrical end 150a. The guide groove 117, transmission channel 115, and pull wire channel 15a extend from the connector 150 through the cylindrical end 150a toward one side of the non-clamping area 116. The transmission channel 115 and the two pull wire channels 15a are in the form of through holes in the connector 150, and the guide groove 117 is in the form of an open incomplete arc at the connector 150. Because the guide groove 117 is curved upward at the inclined section 117a of the first clamping member 11, it may cause more resistance when the puncture needle moves. Therefore, the open form of the connector 150 helps reduce the resistance during the puncture needle's movement.

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

[0091] See also Figure 22 The proximal end of the delivery catheter 16 away from the leaflet capture assembly 10 is connected to an 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 limiter control assembly 182, which can adjust the tension and relaxation of the traction line 15 of the limiter 14, thereby controlling the clamping of the leaflet by the limiter 14. The operating end of the suture implantation assembly 20 can be movably mounted on the end of the housing 180 of the operating handle 18.

[0092] Please also refer to Figures 22 to 24 The suture implantation assembly 20 includes a puncture needle assembly 21 and a suture pusher assembly 22. The puncture needle assembly 21 includes a puncture needle pusher handle 211, a guide assembly 212, and a puncture needle 213. The puncture needle pusher 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 pusher 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 pusher 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 212b is slightly larger than the outer diameter of the puncture needle 213, but can support the puncture needle 213, thereby guiding 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 pushing assembly 22 includes a pushing handle 221, a pushing shaft 222, and a pushing catheter 223. The pushing handle 221 can be simply a ring. One end of the pushing shaft 222 is fixedly connected to the pushing handle 221, and the other end extends into the puncture needle pushing handle 211 and is fixedly connected to the pushing catheter 223. The pushing catheter 223 is movably accommodated in the puncture needle 213. The suture 225 can be loaded into the pushing catheter 223, and the suture 225 does not need to be fixed in the pushing catheter 223. The end of the suture 225 extends out of the pushing catheter 223 and is accommodated in the puncture needle 213. The suture 225 can be passed through a gasket, which is placed at the end of the pushing catheter 223. The end of the suture 225 can be knotted, which facilitates the suture to be pushed out of the puncture needle 213 by the pushing catheter 223.

[0094] Please also refer to Figures 25 to 32 The delivery catheter 16 of the valve repair device 100 can be loaded into a bending adjustment sheath, which can include a first bending adjustment sheath 200 and a second bending adjustment sheath 200. The first bending adjustment sheath 200 and the second bending adjustment sheath 200 serve to guide and bend the valve repair device within cardiac tissue during delivery. The first bending adjustment sheath 200, the second bending adjustment sheath 200, and the valve repair device 100 can be independently operated in vitro. Under medical imaging observation, the leaflet capture assembly 10 is delivered above the heart valve leaflet 400 to be repaired. The second clamping member of the leaflet capture assembly 10 is then opened relative to the first clamping member. The operating handle of the valve repair device 100 can then be fine-tuned to position the second clamping member at a substantially perpendicular angle to align and retract the leaflet. The leaflet capture assembly 10 is then closed to secure the leaflet. The suture implantation assembly 20 can then be operated to puncture the leaflet with the puncture needle 213 and push the suture to the other side of the leaflet.

[0095] After the suture implant assembly 20 of the valve repair device 100 of the present invention pushes the suture to the other side of the valve leaflet, another device can be used to secure the suture to the heart tissue, acting as a suturing device. Alternatively, the suture can directly replace the heart's native chordae tendineae, acting as an artificial chordae tendineae to secure the suture to the papillary muscles. The suture can be made of materials such as PTFE, e-PTFE, PET, and UHMWPE.

[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 and withdrawn.

[0097] It is understood that the above diagrams only illustrate the puncture direction of the valve leaflets from the atrial side to the ventricular side during suture implantation. The valve repair device of the present application can also be used to puncture the valve leaflets 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, and will not be described in detail here.

[0098] The above is only a preferred embodiment of the present application and does not constitute any formal limitation to the present application. Although the present application has been disclosed as above in terms of a preferred embodiment, it is not intended to limit the present application. Any technician familiar with the art can, without departing from the scope of the technical solution of the present application, use the methods and technical contents disclosed above to make many possible changes and modifications to the technical solution of the present application, or modify it into an equivalent embodiment of an equivalent change. Therefore, any simple modification, equivalent change and modification made to the above embodiment based on the technical essence of the present application without departing from the content of the technical solution of the present application still falls within the scope of protection of the technical solution of the present application.

Claims

1. A valve repair device, characterized in that: It includes: A leaflet capture assembly, comprising a first clamping member, a second clamping member, a limiting member, and a transmission assembly, 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 by the transmission assembly; and a suture implantation assembly, the suture implantation assembly comprising a puncture needle and a suture accommodated in the puncture needle and capable of being pushed; the first clamping member being provided with a guide groove; after the leaflet capture 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; The first clamping member and the second clamping member are both provided with a clamping area, and the first clamping member and the second clamping member are respectively provided with a connecting portion, and the clamping areas of the first clamping member and the second clamping member are provided with a plurality of clamping teeth that adapt to each other, and the clamping area of ​​the first clamping member includes a first clamping tooth area and a second clamping tooth area, and a limiting member accommodating groove is formed between the first clamping tooth area and the second clamping tooth area, and the limiting member accommodating groove is lower than the first clamping tooth area and the second clamping tooth area, and the first clamping member is provided with a traction line channel, and the limiting member is accommodated in the limiting member accommodating groove, and one end is fixed on the connecting portion of the first clamping member, and the other end is controlled by the traction line passing through the traction line channel.

2. The valve repair device according to claim 1, wherein: The facing surfaces of the first clamping member and the second clamping member are both provided with the clamping area and the non-clamping area, the guide groove is connected with the non-clamping area of ​​the first clamping member, and at least one of the clamping areas is provided with clamping teeth. 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 connecting portion is located on a side of the clamping area away from the non-clamping area, the connecting portion of the second clamping member is hinged to the connecting portion of the first clamping member, and one end of the transmission assembly is connected to the connecting portion 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 the 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 arranged at relative intervals, 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 transmission channel forms an opening in the clamping area of ​​the first clamping member, the first clamping tooth area and the second clamping tooth area are respectively located on 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: A convex component is respectively provided between the first clamping tooth area, the second clamping tooth area and the connecting portion, and the height of the convex component is higher than the height of the clamping teeth. A groove adapted to the convex component is provided between the clamping area and the connecting portion of the second clamping member.

8. The valve repair device according to claim 6, characterized in that: The restriction member receiving groove spans the opening.

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 member. 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 hinge of the limiting member has a pre-shaped section at one end of the first clamping member so that the limiting member has a tendency to move toward the second clamping member when the traction line is relaxed. The opening divides the pre-shaped section into a first arm and a second arm. 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, wherein: 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, wherein: 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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