Valve repair devices

Abstract

The present application provides a valve repair device, which includes: a main body, a capture member, and a suture implantation assembly, wherein the capture member can be rotated to open or close relative to the main body to capture the leaflets of the valve between the main body and the capture member, the main body is provided with a guide groove, and the capture member is provided with a leaflet retaining groove, one end of the leaflet retaining groove is open and the other end is closed, and when the capture member and the main body are relatively closed, the guide groove extends from the open end of the leaflet retaining groove into the leaflet retaining groove. The suture implantation assembly includes a puncture needle and a suture pushing assembly, the puncture needle passes through the guide groove and punctures the leaflet in the leaflet retaining groove, and the suture pushing assembly pushes the suture out of the puncture needle to reach 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, one aspect of the present application provides a valve repair device, comprising:

[0008] Main body;

[0009] a capture member, the capture member being rotatable relative to the main body to open or close so as to capture the leaflets of the valve between the main body and the capture member, the main body being provided with a guide groove, the capture member being provided with a leaflet retaining groove, and the guide groove extending from an open end of the leaflet retaining groove into the leaflet retaining groove when the capture member and the main body are relatively closed;

[0010] Sutures;

[0011] A suture implantation assembly comprises a puncture needle and a suture pushing assembly, wherein the puncture needle is configured to movably pass through the guide groove and puncture the leaflet in the leaflet limiting groove, and the suture pushing assembly is used to push the suture out of the puncture needle to reach the other side of the leaflet.

[0012] In a preferred embodiment, the capture member includes a first clamping piece and a second clamping piece, one end of the first clamping piece and the second clamping piece are respectively hinged to the main body, and the other ends of the first clamping piece and the second clamping piece are respectively used to cooperate with the main body to clamp the leaflet, and the leaflet limiting groove is formed between the first clamping piece and the second clamping piece.

[0013] In a preferred embodiment, when the capturing member and the main body are relatively closed, the open end of the leaflet limiting groove faces the guide groove, the first clamping piece and the second clamping piece are connected at the bottom of the leaflet limiting groove to form the other closed end of the leaflet limiting groove, and when the capturing member and the main body are relatively closed, the guide groove extends from the open end of the leaflet limiting groove into the leaflet limiting groove.

[0014] In a preferred embodiment, the main body and the capture member both include a connecting area and a clamping area, the bottom of the leaflet limiting groove separates the connecting area and the clamping area of ​​the capture member, one end of the connecting area of ​​the first clamping piece and the second clamping piece is hinged to the connecting area of ​​the main body, the clamping areas of the main body and the capture member cooperate to clamp the leaflets, the guide groove extends from one end of the main body into the clamping area, and is inclined upward relative to the bottom surface of the main body in the clamping area.

[0015] In a preferred embodiment, the bottom of the leaflet limiting groove has a first slope surface, the end point of the guide groove is located between the main body and the clamping area of ​​the capture member, the main body has a second slope surface adjacent to the end point of the guide groove, the first slope surface and the second slope surface are arranged opposite to each other to form a leaflet puncture area, and the main body is also provided with an extension area adjacent to the second slope surface to accommodate the captured leaflet.

[0016] In a preferred embodiment, it also includes a driving unit, which includes a detachably connected driving shaft and a transmission shaft, one end of the transmission shaft is connected to the connection area of ​​the capture member through a connecting rod, when the driving shaft drives the transmission shaft away from the connection area in the main body, the connecting rod pulls the capture member to rotate and open relative to the main body, and when the driving shaft drives the transmission shaft close to the connection area, the connecting rod pushes the capture member to rotate and close relative to the main body.

[0017] In a preferred embodiment, matching portions are provided on two opposite sides of the clamping area of ​​the main body, and the matching portions are provided with first clamping teeth, and the clamping areas of the first clamping piece and / or the second clamping piece are provided with second clamping teeth that cooperate with the first clamping teeth, and the capturing member first rises and then falls relative to the bottom surface of the main body from the end of the connecting area to the end of the clamping area, so that when the capturing member and the main body are relatively closed, the ends of the first clamping piece and the second clamping piece tend to be close to the main body.

[0018] In a preferred embodiment, the main body has a fixed end close to the clamping area, the fixed end includes a base and a connector, the clamping area and the connector are respectively arranged on both sides of the base, the connector is used to connect the delivery catheter, the guide groove extends from the connector through the fixed end to the clamping area, the outer diameter of the base is larger than the outer diameter of the connector, and is larger than the sum of the outer diameters of the capture member and the main body when the capture member and the main body are closed.

[0019] In a preferred embodiment, the mating portion is provided with a contrast agent groove inwardly, and the contrast agent groove extends from the connecting head through the base to the mating portion, and the first clamping piece and the second clamping piece are concave in shape, and when the capturing member is relatively closed to the main body, the first clamping piece and the second clamping piece at least partially cover the contrast agent groove.

[0020] In a preferred embodiment, the clamping area of ​​the main body is provided with flap limiting surfaces on both sides of the guide groove, and the flap limiting surfaces are inclined toward the matching portion. When the capture member and the main body are relatively closed, the first clamping piece and the second clamping piece at least partially cover the flap limiting surfaces.

[0021] In a preferred embodiment, the distal end of the driving shaft is connected to a fixing seat, the distal end of the connecting rod is hinged to the fixing seat, and the proximal end of the connecting rod is fixedly connected to the connecting area of ​​the capturing member.

[0022] In a preferred embodiment, the main body has a front surface and a bottom surface, and when the capturing member is relatively closed to the main body, the capturing member covers the front surface of the main body, the front surface of the main body and the inner surface of the capturing member form the clamping area, and the bottom surface of the main body and the outer surface of the capturing member are smooth, and the bottom surface of the main body is also provided with an open groove, and the open groove is used to observe the connection status of the transmission shaft and the drive shaft.

[0023] Another aspect of the present application provides a valve repair device, comprising:

[0024] Main body;

[0025] a capture member, which can be rotated relative to the main body to open or close to capture the leaflets of the valve between the main body and the capture member, the main body being provided with a guide groove, and the capture member being provided with a leaflet limiting groove;

[0026] artificial chordae tendineae;

[0027] An artificial chord tendon implantation assembly comprises a puncture needle and an artificial chord tendon pushing assembly, wherein the puncture needle is movable through the guide groove and punctures the leaflet in the leaflet limiting groove, and the artificial chord tendon pushing assembly is used to push the artificial chord tendon out of the puncture needle to reach the other side of the leaflet.

[0028] The valve repair device provided by the present invention has the following beneficial effects:

[0029] One of the clamping parts of the leaflet capture assembly of the valve repair device can be rotated relative to the other to open to form an angle or closed to clamp the leaflet between the two. The leaflet limiting groove has a certain limiting effect on the leaflet, making it less likely to slip during puncture; 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

[0030] Figure 1 This is a schematic diagram of the mitral and tricuspid valves in their normal state;

[0031] Figure 2 is a schematic diagram of normal chordae tendineae in the heart;

[0032] Figure 3 is a schematic diagram of a ruptured chordae tendineae in the heart;

[0033] Figure 4 is a partial three-dimensional schematic diagram of a valve repair device provided by an embodiment of the present invention;

[0034] Figure 5 yes Figure 4 A three-dimensional schematic diagram of a valve repair device with a capture member opened relative to the main body;

[0035] Figure 6 yes Figure 4 A three-dimensional schematic diagram of the valve repair device without the puncture needle;

[0036] Figure 7 yes Figure 4 A three-dimensional schematic diagram of the valve repair device from another angle after the puncture needle is removed;

[0037] Figure 8 yes Figure 7 An exploded schematic diagram of the leaflet capture component assembly;

[0038] Figure 9 yes Figure 8 An enlarged schematic diagram of the main body of FIG;

[0039] Figure 10 yes Figure 8 An enlarged schematic diagram of the capture member in FIG.

[0040] Figure 11 yes Figure 7 A schematic diagram of the driving unit driving the capture member to rotate and open relative to the main body;

[0041] Figure 12 yes Figure 11 A schematic diagram of the capture member rotating and opening to the maximum angle relative to the main body when the driving unit moves to the farthest end;

[0042] Figure 13 yes Figure 4A cross-sectional view of a valve repair device;

[0043] Figure 14 yes Figure 13 A schematic cross-sectional view of a valve repair device;

[0044] Figure 15 yes Figure 4 A schematic diagram of a valve repair device including an operating handle;

[0045] Figure 16 yes Figure 15 A partial cross-sectional view of the valve repair device at the operating handle;

[0046] Figure 17 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;

[0047] Figure 18 yes Figure 17 A schematic diagram of a state in which the capture member of the leaflet capture assembly of the valve repair device is opened relative to the main body to form a clamping angle;

[0048] Figure 19 yes Figure 18 A schematic diagram of a state in which a capture member of a valve repair device is aligned with and retracted into a valve leaflet;

[0049] Figure 20 yes Figure 19 A schematic diagram of a valve leaflet capture component of a valve repair device clamping a valve leaflet;

[0050] Figure 21 yes Figure 20 An enlarged schematic diagram of the puncture needle of the valve repair device puncturing the valve leaflet.

[0051] Explanation of Figure Numbers

[0052] Valve repair device 100 Leaflet capture assembly 10 Suture implant assembly 20

[0053] Main body 11 Capturing member 12 Driving unit 13

[0054] Connecting area 112, 122 Clamping area 114, 124 Fixed end 116

[0055] Delivery tube 16 Clamping teeth 110, 120 Matching portion 114a

[0056] First clamping piece 124a Second clamping piece 124b Leaflet limiting groove 126

[0057] Opening 126a First slope 126b Guide groove 117

[0058] End point 117a Leaflet puncture area 126c Extension area 118

[0059] Leaflet limiting surface 119 Contrast agent channel 115 Base 116a

[0060] Connector 116b Transmission channel 113 Ribs 122a, 133c

[0061] Pins 122b, 133a, 133b Spring tube 131a Drive shaft 131

[0062] Transmission shaft 132 Connecting rod 133 First shaft hole 132c

[0063] Second axial hole 132d Open slot 113a Leaflet 400

[0064] Puncture needle 213 Suture 225 Operating handle 18

[0065] Housing 180 Button 181 Contrast medium operation unit 182

[0066] Puncture needle assembly 21 Suture pusher assembly 22 Puncture needle pusher handle 211

[0067] Guide assembly 212 guide sleeve 212a guide shaft 212b

[0068] Suture pushing handle 221 pushing shaft 222 pushing catheter 223

[0069] First bending sheath 200 Second bending sheath 300 DETAILED DESCRIPTION

[0070] 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.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] 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.

[0075] 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).

[0076] See also Figure 4 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 main body 11, a capture member 12, and a drive unit 13. Driven by the drive unit 13, the capture member 12 can be opened to a certain angle relative to the main body 11, or closed to capture and clamp the leaflets between the main body 11 and the capture member 12.

[0077] In this embodiment, the main body 11 is a block-shaped base, the capturing member 12 covers the main body 11 and is hinged to the main body 11, one end of the driving unit 13 is connected to the capturing member 12, and the other end is movably transmitted in the main body 11.

[0078] For details, please refer to Figures 5 to 10 The main body 11 is provided with a connection area 112, a clamping area 114, and a fixed end 116, respectively, from the distal end away from the operator to the proximal end closer to the operator. The capture member 12 is provided with a connection area 122 and a clamping area 124, respectively, from the distal end away from the operator to the proximal end closer to the operator. The connection area 122 of the capture member 12 is hingedly connected to the connection area 112 of the main body 11, and the clamping area 124 of the capture member 12 faces the clamping area 114 of the main body 11. The fixed end 116 of the main body 11 is connected to a delivery catheter 16.

[0079] At least one of the clamping area 114 of the main body 11 and the clamping area 124 of the capture member 12 is provided with clamping teeth to provide a clamping force on the leaflet. In this embodiment, the clamping area 114 of the main body 11 is provided with clamping teeth 110, and the clamping area 124 of the capture member 12 is provided with clamping teeth 120. There is a tooth groove between two adjacent clamping teeth. When the main body 11 and the capture member 12 are relatively closed, the clamping teeth 110 of the main body 11 engage with the tooth groove of the capture member 12, and the tooth groove of the main body 11 engages with the clamping teeth 120 of the capture member 12. In this embodiment, the clamping teeth 110 of the main body 11 are located on two opposite sides of the clamping area 114, and the clamping teeth 110 on each side are arranged longitudinally. The clamping teeth 120 of the capture member 12 also include two rows, arranged longitudinally from the proximal end to the distal end along the inner surface of the clamping area 124.

[0080] Please also refer to Figure 5 、 Figure 7 and Figure 10 In this embodiment, the two sides of the clamping teeth 110 of the main body 11 form a matching portion 114a that matches with the capture member 12. The capture member 12 has a first clamping piece 124a and a second clamping piece 124b. The two rows of clamping teeth 120 of the capture member 12 are respectively located on one side of the first clamping piece 124a and the second clamping piece 124b. The inner surfaces of the first clamping piece 124a and the second clamping piece 124b have a certain concave shape (see Figure 5 ), when the capture member 12 and the main body 11 are relatively closed, the first clamping piece 124a and the second clamping piece 124b cover the mating portion 114a. The ends of the first clamping piece 124a and the second clamping piece 124b are spaced a certain distance from the fixed end 116 of the main body 11, so that the movement of the first clamping piece 124a and the second clamping piece 124b is not hindered by the fixed end 116.

[0081] A leaflet limiting groove 126 is formed between the first clamping piece 124a and the second clamping piece 124b, and the leaflet limiting groove 126 is open at the ends of the first clamping piece 124a and the second clamping piece 124b to form an opening 126a. In this embodiment, the other end of the leaflet limiting groove 126 opposite to the opening 126a is closed to form the bottom of the leaflet limiting groove 126, and the first clamping piece 124a and the second clamping piece 124b are connected at the bottom of the leaflet limiting groove 126 to form a whole.

[0082] Please also refer to Figure 8 and Figure 9The main body 11 is provided with a guide groove 117 for guiding a puncture needle or other suture implantation assembly 20. When the capture member 12 and the main body 11 are relatively closed, the guide groove 117 extends from the opening 126a of the leaflet retaining groove 126 into the leaflet retaining groove 126. The depth of the leaflet retaining groove 126 is defined by the distance from the first clamping piece 124a and the second clamping piece 124b at the end of the clamping area 114 to the bottom of the leaflet retaining groove 126. This depth can be determined based on the required travel of the puncture needle or other suture implantation assembly 20. In addition, the guide groove 117 is designed to be inclined, that is, the guide groove 117 is inclined upward relative to one end of the main body 11 or relative to the bottom surface of the main body 11 in the clamping area 114. In this way, when the leaflet is captured in the clamping area 114, the leaflet is pressed between the guide groove 117 and the leaflet retaining groove 126, thereby clamping it more tightly, facilitating puncture of the suture implant assembly 20 such as a puncture needle. The inclination angle of the guide groove 117 in the clamping area 114 is preferably between 20 and 60 degrees.

[0083] In this embodiment, the leaflet limiting groove 126 is relatively narrow and long, and the end position 117a of the guide groove 117 in the clamping area 114 is a certain distance away from the bottom of the leaflet limiting groove 126 (see Figure 6 The bottom of the leaflet retaining groove 126 has a first slope 126b, and the main body 11 has a second slope 117b adjacent to the end point 117a of the guide groove 117. The first slope 126b and the second slope 117b at the bottom of the leaflet retaining groove 126 face each other to form a leaflet puncture area 126c. The main body 11 also has an extension area 118 adjacent to the second slope 118b. The extension area 118 is substantially planar and is used to accommodate the leaflets extending into the extension area 118.

[0084] The clamping area 114 of the main body 11 is provided with flap-restricting surfaces 119 on both sides of the guide groove 118. When the capture member 12 and the main body 11 are relatively closed, the first clamping piece 124a and the second clamping piece 124b partially cover the flap-restricting surfaces 119. The flap-restricting surfaces 119 are inclined toward the mating portion 114a. When the flap is clamped between the capture member 12 and the main body 11, a portion of the flap is covered by the first clamping piece 124a and the second clamping piece 124b on the flap-restricting surfaces 119. In this way, the flap-restricting surfaces 119 play a role in flap restriction.

[0085] A contrast agent channel 115 is provided at a position adjacent to the clamping teeth 110 on the mating portion 114a of the main body 11. The contrast agent channel 115 extends from the fixed end 116 into the clamping area 114. The contrast agent channel 115 can be used to place a contrast agent tube (not shown). Contrast agent flows into the clamping area 114 through the contrast agent tube. When the capture member 12 captures the leaflets and closes the leaflets on the main body 11, the contrast agent will be blocked by the leaflets. The blocked contrast agent can be observed under medical imaging, thereby verifying that the leaflets are captured and clamped in the appropriate position.

[0086] The fixed end 116 of the main body 11 includes a base 116a and a connector 116b. The clamping area 114 and connector 116b are respectively disposed on either side of the base 116b. The connector 116b is used to connect to and securely attach to the delivery catheter 16. The guide groove 117 extends from the connector 116b through the fixed end 116 to the clamping area 114. The contrast agent channel 115 also extends from the connector 116b through the fixed end 116 to the clamping area 114. The outer diameter of the base 116a is larger than that of the connector 116b and larger than the sum of the outer diameters of the capture member 12 and the main body 11 when the capture member 12 and the main body 11 are closed. This ensures that the maximum outer diameter of the valve repair device 100 is the outer diameter of the base 116b. This prevents the capture member 12 from becoming caught on the delivery sheath during delivery.

[0087] The first clamping piece 124a and the second clamping piece 124b are formed as two spaced-apart ribs 122a at one end of the connecting section 122. The ends of the ribs 122a are hingedly connected to the connecting section 112 of the main body 11. The hinged connection can be achieved by inserting a pin 122b into the axial holes of the ribs 122a and the connecting section 112. This hinged connection allows the capture member 12 to rotate open or close relative to the main body 11 under the action of an external force.

[0088] Please see again Figure 8 The main body 11 further includes a transmission channel 113 extending from the connector 116b through the fixed end 116 to the connection area 112. The drive unit 13 includes a drive shaft 131 and a transmission shaft 132. The drive shaft 131 and the transmission shaft 132 are detachably connected and movable within the transmission channel 113. The drive shaft 131 may be a metal wire, and a spring tube 131a may be sheathed on the outside. The spring tube 131a protects the drive shaft 131 and helps the drive shaft 131 return to its normal position when deflected or bent.

[0089] One end of the transmission shaft 132 is connected to the connection area 122 of the capture member 12 through a connecting rod 133. Specifically, the distal end of the transmission shaft 132 is connected to a fixed seat 132a, and the distal end of the connecting rod 133 is hinged to the fixed seat 132a through a pin 133a. This hinge enables the distal end of the connecting rod 133 to rotate open or close relative to the fixed seat 132a under the action of an external force. The proximal end of the connecting rod 133 is fixedly connected to the connection area 122 of the capture member 12 through a pin 133b. Refer to Figure 8 , in this embodiment, the distal end of the connecting rod 133 has two opposite ribs 133c, and the proximal end of the connecting rod 133 has a cylinder 133d with a shaft hole. The fixed seat 132a has a first shaft hole 132c and a second shaft hole 132d. The first shaft hole 132c is used for inserting and fixing the transmission shaft 132, and the second shaft hole 132d is used for clamping between the two ribs 133c of the connecting rod 133. The second shaft hole 132d can be fixed to the pin 133a.

[0090] When the capture member 12 is closed relative to the main body 11, the distance L2 between the pins 133a and 133b is equal to the sum of the distance L1 between the pin 133b and the pin 122b and the distance L3 between the pin 133a and the pin 122b, that is, L2 = L1 + L3 at this time. Please refer to Figure 11 , when the drive shaft 131 drives the transmission shaft 132 away from the connection area 112 of the main body 11, the connecting rod 133 pulls the capture member 12 to rotate the capture member 12 around the pin 133b, so that the capture member 12 rotates open relative to the main body 11; or at this time, the drive shaft 131 drives the transmission shaft 132 closer to the connection area 112, and the connecting rod 133 pushes the capture member 12 to rotate the capture member 12 around the pin 133b, so that the capture member 12 rotates closed relative to the main body 11. In this state, L2 < L1 + L3. Please refer to <000,0237>, the drive shaft 131 can drive the transmission shaft 132 away from the connection area 112 of the main body 11 to the farthest state, and at this time the capture member 12 is opened relative to the main body 11 to the maximum angle.

[0091] Please refer to Figure 7 and <, Figure 10 , the capture member 12 is designed to rise first and then fall from the end of the connection area 122 to the end of the clamping area 124, so that when the capture member 12 is closed relative to the main body 11, the ends of the first clamping piece 124a and the second clamping piece 124b have a tendency to stick to the main body 11, so that the first clamping piece 124a and the second clamping piece 124b are not easily opened by mistake. Specifically, as Figure 7As shown, the bottom surface of the main body 11 can be used as a reference. The capture member 12 goes through two high points A and B from the end of the connection area 122 to the end of the clamping area 124. The capture member 12 is in an ascending shape from the end of the connection area 122 to point A, and is relatively smooth from point A to point B. The shape of point B makes its outer surface reach the highest point, and it is in a slightly descending shape from point B to the end of the clamping area 124. In this way, when the capture member 12 and the main body 11 are relatively closed, the ends of the first clamping piece 124a and the second clamping piece 124b tend to be close to the main body 11.

[0092] Please also refer to Figure 4 、 Figure 13 and Figure 14 The bottom surface of the main body 11 is provided with an open groove 113a, and the open groove 113a is used to observe the connection state of the drive shaft 131 and the transmission shaft 132. In this embodiment, the drive shaft 131 and the transmission shaft 132 are threadedly connected (see Figure 13 The bottom surface of the main body 11 and the outer surface of the capture member 12 are both rounded, so that the entire leaflet capture assembly 10 is not easily hooked by the delivery sheath or the chordae tendineae of the heart. More specifically, the bottom surface of the main body 11 and the outer surface of the capture member 12 can both be designed to be rounded.

[0093] After the capture member 12 cooperates with the main body 11 to capture the leaflet 400, the suture implantation assembly implants the suture 225 into the captured leaflet 400. The suture implantation assembly uses the puncture needle 213 to puncture the leaflet, and then pushes the suture 225 from the inside of the puncture needle 213 to the outside to reach the other side of the leaflet. The puncture needle has a specific needle tip, and the needle tip's puncture point at the leaflet is optimally located at the middle point of the leaflet retaining groove 126, or two-thirds of the puncture needle's area is accommodated by the leaflet retaining groove 126 to allow the needle tip to puncture the leaflet, preventing the puncture needle from slipping and ensuring stable puncture.

[0094] Please also refer to Figure 13 、 Figure 15 and Figure 16The delivery catheter 16 is an elongated polymer material catheter, and its proximal end 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 131. 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 131 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 connecting rod 133 to pull or push the capture member 12 to open or close relative to the main body 11. The operating handle 18 is further provided with a contrast agent operating portion 182 for introducing contrast agent. 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.

[0095] In this embodiment, 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 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 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.

[0096] The suture pushing assembly 22 includes a suture pushing handle 221, a pushing shaft 222 and a pushing catheter 223. The suture pushing handle 221 can be only an annular tube. 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 gasket can be, for example, a non-deformable cylindrical or block-shaped. The end of the suture 225 can be knotted (see Figure 14 ), which helps the pushed catheter 223 to be pushed out of the puncture needle 213.

[0097] Please also refer to Figures 17 to 21The delivery catheter 16 of the valve repair device 100 can be loaded into a bending sheath, which can include a first bending sheath 200 and a second bending sheath 300. The first bending sheath 200 and the second bending sheath 300 serve to guide and bend the valve repair device within cardiac tissue during delivery. The first bending sheath 200, the second bending sheath 300, 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 insert the puncture needle 213 through the leaflet and push the suture through the puncture needle 213 to the other side of the leaflet.

[0098] 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.

[0099] 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.

[0100] 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.

[0101] 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: Main body; a capture member, the capture member being rotatable relative to the main body to open or close so as to capture the leaflets of the valve between the main body and the capture member, the main body being provided with a guide groove, the capture member being provided with a leaflet retaining groove, one end of the leaflet retaining groove being open and the other end being closed, and when the capture member and the main body are relatively closed, the guide groove extends from the open end of the leaflet retaining groove into the leaflet retaining groove; Sutures; a suture implantation assembly, the suture implantation assembly comprising a puncture needle and a suture pushing assembly, the puncture needle being configured to movably pass through the guide slot and puncture the leaflet in the leaflet retaining slot, the suture pushing assembly being used to push the suture out of the puncture needle to reach the other side of the leaflet; The cam is configured to have a first end for camming the second end of the guide rail and a second end for camming the second end of the guide rail.

2. The valve repair device according to claim 1, characterized in that: One end of the first clamping piece and the second clamping piece are respectively hinged to the main body, and the other ends of the first clamping piece and the second clamping piece are respectively used to cooperate with the main body to clamp the leaflet.

3. The valve repair device according to claim 2, characterized in that: When the capture member is relatively closed to the main body, the open end of the leaflet limiting groove faces the guide groove, and the first clamping piece and the second clamping piece are connected at the bottom of the leaflet limiting groove to form the other closed end of the leaflet limiting groove.

4. The valve repair device according to claim 3, characterized in that: The bottom of the leaflet limiting groove separates the connection area and the clamping area of ​​the capture member, one end of the connection area of ​​the first clamping piece and the second clamping piece is hinged to the connection area of ​​the main body, the main body and the clamping area of ​​the capture member cooperate to clamp the leaflet, and the guide groove extends from one end of the main body into the clamping area, and is inclined upward relative to the bottom surface of the main body in the clamping area.

5. The valve repair device according to claim 4, characterized in that: The bottom of the leaflet limiting groove has a first slope surface, the end point of the guide groove is located between the main body and the clamping area of ​​the capture member, the main body has a second slope surface adjacent to the end point of the guide groove, the first slope surface and the second slope surface are arranged opposite to each other to form a leaflet puncture area, and the main body is also provided with an extension area adjacent to the second slope surface to accommodate the captured leaflet.

6. The valve repair device according to claim 4, characterized in that: It also includes a driving unit, which includes a detachably connected driving shaft and a transmission shaft, one end of the transmission shaft is connected to the connection area of ​​the capture member through a connecting rod, when the driving shaft drives the transmission shaft away from the connection area in the main body, the connecting rod pulls the capture member to rotate and open relative to the main body, and when the driving shaft drives the transmission shaft close to the connection area, the connecting rod pushes the capture member to rotate and close relative to the main body.

7. The valve repair device according to claim 1, wherein: The main body has a fixed end close to the clamping area, and the fixed end includes a base and a connector. The clamping area and the connector are respectively arranged on both sides of the base. The connector is used to connect the delivery catheter. The guide groove extends from the connector through the fixed end to the clamping area. The outer diameter of the base is larger than the outer diameter of the connector, and is larger than the sum of the outer diameters of the capture member and the main body when the capture member and the main body are closed.

8. The valve repair device according to claim 7, characterized in that: The mating portion is provided with a contrast agent groove inwardly, and the contrast agent groove extends from the connecting head through the base to the mating portion. The first clamping piece and the second clamping piece are concave in shape. When the capturing member and the main body are relatively closed, the first clamping piece and the second clamping piece at least partially cover the contrast agent groove.

9. The valve repair device according to claim 6, characterized in that: The distal end of the driving shaft is connected to a fixing seat, the distal end of the connecting rod is hinged to the fixing seat, and the proximal end of the connecting rod is fixedly connected to the connecting area of ​​the capturing member.

10. The valve repair device according to claim 6, wherein: The main body has a front surface and a bottom surface. When the capturing member is relatively closed to the main body, the capturing member covers the front surface of the main body. The front surface of the main body and the inner surface of the capturing member form the clamping area. The bottom surface of the main body and the outer surface of the capturing member are smooth. The bottom surface of the main body is also provided with an open groove, and the open groove is used to observe the connection status of the transmission shaft and the drive shaft.

11. A valve repair device, characterized in that: It includes: Main body; a capture member, the capture member being rotatable relative to the main body to open or close so as to capture the leaflets of the valve between the main body and the capture member, the main body being provided with a guide groove, and the capture member being provided with a leaflet retaining groove, wherein one end of the leaflet retaining groove is open and the other end is closed; artificial chordae tendineae; an artificial chord tendon implantation assembly, the artificial chord tendon implantation assembly comprising a puncture needle and an artificial chord tendon pushing assembly, the puncture needle being movable through the guide groove and puncturing the leaflet in the leaflet limiting groove, the artificial chord tendon pushing assembly being used to push the artificial chord tendon out of the puncture needle to reach the other side of the leaflet; The cam is configured to have a first end for camming the second end of the guide rail and a second end for camming the second end of the guide rail.

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