Valve repair instrument

Abstract

The invention provides a valve repairing instrument which comprises a main body part, a capturing part and a suture implanting assembly, the capturing part can be rotationally opened or closed relative to the main body part so as to capture a valve leaflet of a valve between the main body part and the capturing part, the main body part is provided with a guide groove, the capturing part is provided with a valve leaflet limiting groove, and the suture implanting assembly is arranged in the guide groove. One end of the valve leaflet limiting groove is open, the other end of the valve leaflet limiting groove is closed, and when the capturing piece and the main body part are relatively closed, the guide groove extends into the valve leaflet limiting groove from the open end of the valve leaflet limiting groove. The suture implanting assembly comprises a puncture needle and a suture pushing assembly, the puncture needle penetrates through the guide groove and punctures the valve leaflet in the valve leaflet limiting groove, and the suture pushing assembly pushes a suture out of the puncture needle to reach the other side of the valve leaflet.

Description

Technical Field

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

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

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

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

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

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

[0007] In order to achieve the above-mentioned object, one aspect of the present application provides a valve repair device, which comprises:

[0008] Main body;

[0009] A capture member, 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, the capture member is provided with a leaflet limiting groove, and when the capture member and the main body are relatively closed, the guide groove extends from an open end of the leaflet limiting groove into the leaflet limiting groove;

[0010] Sutures;

[0011] A suture implantation assembly, comprising 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 capturing member comprises 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, 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 leaflets, 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 plate and the second clamping plate 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 capturing 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 capturing member, one end of the connecting area of ​​the first clamping plate and the second clamping plate are both hinged to the connecting area of ​​the main body, the clamping areas of the main body and the capturing member cooperate to clamp the leaflets, the guide groove extends from one end of the main body into the clamping area, and in the clamping area is inclined upward relative to the bottom surface of the main body.

[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 adjacent to the end point of the guide groove has a second slope surface, 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 adjacent to the second slope surface is also provided with an extension area 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 connecting area of ​​the capture member through a connecting rod, when the driving shaft drives the transmission shaft away from the connecting 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 connecting area, the connecting rod pushes the capture member to rotate and close relative to the main body.

[0017] In a preferred embodiment, matching parts are provided on two opposite sides of the clamping area of ​​the main body, and the matching parts 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 matching 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 and the main body are relatively closed, 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, respectively, and the flap limiting surfaces are inclined toward the matching portion, and 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, and 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 an open groove is also provided on the bottom surface of the main body, 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 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 limiting groove;

[0026] Artificial chordae;

[0027] An artificial chord implantation assembly, the artificial chord implantation assembly comprising a puncture needle and an artificial chord pushing assembly, the puncture needle can movably pass through the guide groove and puncture the leaflet in the leaflet limiting groove, and the artificial chord pushing assembly is used to push the artificial chord 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 difficult to slip during puncture; the suture can be implanted as an artificial chord 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 valve and tricuspid valve in 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 in which a capture member is opened relative to a 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 in FIG.

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

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

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

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

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

[0043] Fig.14 yes Fig.13 A cross-sectional schematic diagram of a valve repair device;

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

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

[0046] Fig.17 It is a schematic diagram of a state in which the valve repair device provided by an embodiment of the present invention is loaded with a first bending adjustment sheath and a second bending adjustment sheath to deliver a valve leaflet capture component to heart tissue;

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

[0048] Fig.19 yes Fig.18 A schematic diagram of a state in which a capture member of a valve repair device is aligned with a valve leaflet and is received in the valve leaflet;

[0049] Fig. 20 yes Fig.19 A schematic diagram of a state in which a leaflet capturing component of a valve repair device clamps a leaflet;

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

[0051] Description 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 medium channel 115 Base 116a

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

[0061] Pin 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 push assembly 22 Puncture needle push handle 211

[0068] Guide assembly 212 Guide sleeve 212a Guide shaft 212b

[0069] Suture push handle 221 push shaft 222 push catheter 223

[0070] First bending sheath 200 Second bending sheath 300 DETAILED DESCRIPTION

[0071] In order to make the objectives, technical solutions and advantages of the present application clearer, the present application will be further described in detail below in conjunction with the accompanying drawings.

[0072] It should be understood that expressions such as "including" and "may include" that may be used in the present application indicate the existence of the disclosed functions, operations, or constituent elements, and do not limit one or more additional functions, operations, and constituent elements. In the present disclosure, terms such as "including" and / or "having" may be interpreted as indicating specific characteristics, numbers, operations, constituent elements, components, or combinations thereof, but may not be interpreted as excluding the existence or possibility of adding one or more other characteristics, numbers, operations, constituent elements, components, or combinations thereof.

[0073] In addition, in the present application, the expression "and / or" includes any and all combinations of the associated listed words. For example, the expression "A and / or B" may include A, may include B, or may include both A and B.

[0074] In the present application, expressions including ordinal numbers such as "first" and "second" can modify various elements. However, such elements are not limited by the above expressions. For example, the above expressions do not limit the order and / or importance of the elements. The above expressions are only used to distinguish one element from other elements. Similarly, without departing from the scope of the present disclosure, the first element can be referred to as the second element, and similarly, the second element can also be referred to as the first element.

[0075] When a component is referred to as being "connected" or "accessed" to another component, it should be understood that the component is not only directly connected to or accessed to the other component, but also another component may exist between the component and the other component. On the other hand, when a component is referred to as being "directly connected" or "directly accessed" to another component, it should be understood that there is no component between them.

[0076] In the field of interventional medical device technology, the direction close to the operator is generally defined as the proximal end, and the direction away from the operator is defined as the distal end. The direction of the rotation center axis of an object such as a cylinder or a tube is defined as the axial direction. The circumferential direction is the direction around the axis of an object such as a cylinder or a tube (perpendicular to the axis and also perpendicular to the cross-sectional radius).

[0077] See also Figure 4 The valve repair device 100 provided in one embodiment of the present application includes a leaflet capture component 10 and a suture implantation component 20. The leaflet capture component 10 includes a 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 at a certain angle relative to the main body 11, or closed to capture and clamp the leaflet between the main body 11 and the capture member 12.

[0078] In this embodiment, the main body 11 is a block-shaped base, the capture member 12 covers the main body 11 and is hinged on the main body 11, one end of the driving unit 13 is connected to the capture member 12, and the other end is movably transmitted in the main body 11.

[0079] For details, please refer to Figures 5 to 10The main body 11 is provided with a connection area 112, a clamping area 114 and a fixed end 116 from the distal end away from the operator to the proximal end close to the operator. The capture member 12 is provided with a connection area 122 and a clamping area 124 from the distal end away from the operator to the proximal end close to the operator. The connection area 122 of the capture member 12 is hinged 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.

[0080] 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 clamping force to 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, and 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 are engaged with the tooth groove of the capture member 12, and the tooth groove of the main body 11 is engaged with the clamping teeth 120 of the capture member 12. In this embodiment, the clamping teeth 110 of the main body 11 are located at two opposite sides of the clamping area 114, and the clamping teeth 110 of each side are arranged in the longitudinal direction. The clamping teeth 120 of the capture member 12 also include two rows, which are arranged in the longitudinal direction from the proximal end to the distal end along the inner surface of the clamping area 124.

[0081] Please also read Figure 5 , Figure 7 and Fig.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 are in 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 matching 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 will not be hindered by the fixed end 116.

[0082] 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.

[0083] Please also read Figure 8 and Fig. 9 The main body 11 is provided with a guide groove 117 for guiding the puncture needle and other suture implantation components 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 limiting groove 126 into the leaflet limiting groove 126. The depth of the leaflet limiting groove 126 is from the end of the first clamping piece 124a and the second clamping piece 124b at the clamping area 114 to the bottom of the leaflet limiting groove 126, and the depth can be determined according to the travel requirements of the puncture needle and other suture implantation components 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, so that when the leaflet is captured in the clamping area 114, the leaflet is pressed between the guide groove 117 and the leaflet limiting groove 126, so that it is clamped more tightly, which is conducive to the puncture of the suture implantation assembly 20 such as the puncture needle. The inclination angle of the guide groove 117 in the clamping area 114 is preferably between 20-60 degrees.

[0084] 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 limiting groove 126 has a first slope 126b, and the main body 11 has a second slope 117b adjacent to the end position 117a of the guide groove 117. The first slope 126b and the second slope 117b at the bottom of the leaflet limiting groove 126 are arranged opposite to each other to form a leaflet puncture area 126c. The main body 11 is also provided with an extension area 118 adjacent to the second slope 118b. The extension area 118 is substantially flat and is used to accommodate the leaflet extending into the extension area 118.

[0085] The clamping area 114 of the main body 11 is provided with flap limiting surfaces 119 on both sides of the guide groove 118, and the first clamping piece 124a and the second clamping piece 124b cover part of the flap limiting surface 119 when the capture member 12 and the main body 11 are relatively closed. The flap limiting surface 119 is inclined toward the direction of the matching portion 114a, and when the flap is clamped between the capture member 12 and the main body 11, part of the flap is covered by the first clamping piece 124a and the second clamping piece 124b on the flap limiting surface 119, so that the flap limiting surface 119 plays a role in flap limiting.

[0086] A contrast medium channel 115 is provided at a position of the matching portion 114a of the main body 11 adjacent to the clamping teeth 110, and the contrast medium channel 115 extends from the fixed end 116 into the clamping area 114. The contrast medium channel 115 can be used to place a contrast medium tube (not shown), and the contrast medium flows into the clamping area 114 through the contrast medium tube. When the capture member 12 captures the leaflet and closes the leaflet on the main body 11, the contrast medium will be blocked by the leaflet. The blocked contrast medium that cannot flow can be observed under medical imaging, thereby verifying that the leaflet is captured and clamped at a suitable position.

[0087] The fixed end 116 of the main body 11 includes a base 116a and a connector 116b. The clamping area 114 and the connector 116b are respectively arranged on both sides of the base 116b. The connector 116b is used to connect and fix with 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 medium 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 the outer diameter of the connector 116b, and is 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, so that the maximum outer diameter of the valve repair device 100 is the outer diameter of the base 116b, so that the capture member 12 will not be hooked by the delivery sheath during delivery.

[0088] The first clamping piece 124a and the second clamping piece 124b are formed as two ribs 122a arranged at intervals relative to each other at one end of the connection area 122, and the ends of the ribs 122a are hinged to the connection area 112 of the main body 11. The hinge can be inserted into the axial holes of the ribs 122a and the connection area 112 by a pin 122b, and the hinge enables the capture member 12 to rotate relative to the main body 11 to open or close under the action of an external force.

[0089] Please see again Figure 8, a transmission channel 113 is further provided inside the main body portion 11. The transmission channel 113 extends from the connection head 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 within the transmission channel 113 and are movable within the transmission channel 113. The drive shaft 131 can be a wire, and a spring tube 131a can be sleeved outside it. The spring tube 131a protects the drive shaft 131 and causes the drive shaft 131 to return to its original position when it deflects and bends.

[0090] 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. 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 is two opposite ribs 133c, and the proximal end of the connecting rod 133 is a cylinder 133d with a shaft hole. There are a first shaft hole 132c and a second shaft hole 132d on the fixed seat 132a. The first shaft hole 132c is for the transmission shaft 132 to be inserted and fixed, and the second shaft hole 132d is for clamping between the two ribs 133c of the connecting rod 133. The second shaft hole 132d can be fixed to the pin 133a.

[0091] When the capture member 12 is closed relative to the main body portion 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 Fig.11 , when the drive shaft 131 drives the transmission shaft 132 away from the connection area 112 of the main body portion 11, the connecting rod 133 pulls the capture member 12 to make the capture member 12 rotate around the pin 133b, so that the capture member 12 rotates and opens relative to the main body portion 11; or at this time, when the drive shaft 131 drives the transmission shaft 132 close to the connection area 112, the connecting rod 133 pushes the capture member 12 to make the capture member 12 rotate around the pin 133b, so that the capture member 12 rotates and closes relative to the main body portion 11. In this state, L2 < L1 + L3. Please refer to Fig.12 , the drive shaft 131 can drive the transmission shaft 132 away from the connection area 112 of the main body portion 11 to the farthest state, and at this time, the capture member 12 is opened relative to the main body portion 11 to the maximum angle.

[0092] Please also read Figure 7 and Fig.10 The capture member 12 is designed to first rise 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 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, so that the first clamping piece 124a and the second clamping piece 124b are not easily opened by mistake. Specifically, Figure 7 As 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 connecting area 122 to the end of the clamping area 124. The capture member 12 is in an ascending shape from the end of the connecting area 122 to point A, and the distance from point A to point B is relatively gentle. 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.

[0093] Please also read Figure 4 , Fig.13 and Fig.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 Fig.13 ). The bottom surface of the main body 11 and the outer surface of the capture member 12 are both smooth, so that the entire leaflet capture assembly 10 is not easily hooked by the delivery sheath or the tendons of the heart. More specifically, the bottom surface of the main body 11 and the outer surface of the capture member 12 can be designed to be circular.

[0094] 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 certain needle tip, and the needle tip is optimally located at the middle point of the leaflet limiting groove 126 at the puncture point of the leaflet, or two-thirds of the area of ​​the puncture needle is accommodated by the leaflet limiting groove 126 to enable the needle tip to puncture the leaflet, so that the puncture of the puncture needle will not slip and the puncture is stable.

[0095] Please also read Fig.13 , Fig.15 and Fig.16The delivery catheter 16 is an elongated polymer material catheter, and its proximal end away from the leaflet capture component 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 part 182 for introducing contrast agent. The operating end of the suture implantation component 20 can be movably mounted at the end of the housing 180 of the operating handle 18.

[0096] In this embodiment, the suture implantation assembly 20 includes a puncture needle assembly 21 and a suture push assembly 22. The puncture needle assembly 21 includes a puncture needle push handle 211, a guide assembly 212 and a puncture needle 213. The puncture needle push handle 211 is movably accommodated in the housing 180 of the operating handle 18, and the puncture needle 213 is fixedly connected to the puncture needle push handle 211. The guide assembly 212 includes a guide sleeve 212a and a guide shaft 212b. The guide sleeve 212a is fixedly connected to the puncture needle push handle 211. The guide shaft 212b is fixed in the housing 180 of the operating handle 18, and one end of the guide sleeve 212a is accommodated in the guide sleeve 212a. The inner diameter of the guide sleeve 212a is slightly larger than the outer diameter of the puncture needle 213, but it can support the puncture needle 213, so as to guide the puncture needle 213. When the puncture needle pushing handle 211 is pushed, the guide sleeve 212a moves axially along the outer diameter of the guide shaft 212b, and the puncture needle 213 is pushed along the inner diameter of the guide shaft 212b through the delivery catheter 16 to reach the guide groove 117 of the leaflet capture assembly 10.

[0097] The suture push assembly 22 includes a suture push handle 221, a push shaft 222, and a push catheter 223. The suture push handle 221 can be only an annular tube. One end of the push shaft 222 is fixedly connected to the push handle 221, and the other end extends into the puncture needle push handle 211 and is fixedly connected to the push catheter 223. The push catheter 223 is movably accommodated in the puncture needle 213. The suture 225 can be loaded into the push catheter 223, and the suture 225 does not need to be fixed in the push catheter 223. The end of the suture 225 extends out of the push catheter 223 and is accommodated in the puncture needle 213. The suture 225 can be inserted on a gasket, which is placed at the end of the push catheter 223. The gasket can be, for example, a non-deformed cylindrical or block-shaped. The end of the suture 225 can be knotted (see Fig.14 ), which helps the pushed catheter 223 to be pushed out of the puncture needle 213.

[0098] Please also read Figures 17 to 21The delivery catheter 16 of the valve repair device 100 can be loaded in the bending sheath, and the bending sheath can include a first bending sheath 200 and a second bending sheath 300. The first bending sheath 200 and the second bending sheath 300 play a role in guiding and bending in the heart tissue during the delivery process of the valve repair device. The first bending sheath 200, the second bending sheath 300 and the valve repair device 100 can be operated independently in vitro, and the leaflet capture assembly 10 is delivered to the upper part of the heart leaflet 400 to be repaired under the observation of medical images. Then, the second clamping member of the leaflet capture assembly 10 is opened relative to the first clamping member. At this time, the operating handle of the valve repair device 100 can be fine-tuned to make the second clamping member be at an angle substantially perpendicular to the leaflet to align with the leaflet and receive the leaflet. At this time, the leaflet capture assembly 10 is closed to clamp the leaflet, and then the suture implantation assembly 20 can be operated to puncture the leaflet with the puncture needle 213, and the suture is pushed out of the puncture needle 213 to the other side of the leaflet.

[0099] After the suture implantation assembly 20 of the valve repair device 100 of the embodiment of the present invention pushes the suture to the other side of the valve leaflet, the suture can be fixed to the heart tissue by another device to play a suturing role, or the suture can directly replace the work of the native chordae tendineae of the heart, that is, it can be fixed to the papillary muscle as an artificial chordae tendineae. The material of the suture can be PTFE, e-PTFE, PET, UHMWPE, etc.

[0100] After the suture implantation of the valve repair device 100 according to the embodiment of the present invention is completed, the suture is left in the heart tissue, the puncture needle is withdrawn, and then the leaflet capture assembly 10 is withdrawn, so that the valve repair device 100 is separated from the heart tissue as a whole and withdrawn.

[0101] It is understandable that the above diagram only uses the puncture direction of the valve leaflet from the atrial side to the ventricular side when the suture is implanted as an example. The valve repair device of the present application can also be used to puncture the valve leaflet from the ventricular side to the atrial side, for example, using a delivery path through the right ventricle-ventricular septum-left ventricle-mitral valve, or a delivery path through the apex-left ventricle-mitral valve. Of course, the valve repair device of the present application can also be used for suture implantation of the tricuspid valve. Except for the difference in the path of the interventional surgery, the structure of the tricuspid valve repair device is the same as that of the mitral valve repair device, which will not be repeated here.

[0102] The above are only the preferred implementation modes of the present application, and are not intended to limit the present application in any form. Although the present application has been disclosed as above in terms of the preferred implementation modes, it is not intended to limit the present application. Any technician familiar with the art can use the methods and technical contents disclosed above to make many possible changes and modifications to the technical solutions of the present application, or modify them into equivalent implementation modes with equivalent changes, without departing from the scope of the technical solutions of the present application. Therefore, any simple modifications, equivalent changes and modifications made to the above implementation modes based on the technical essence of the present application, which do not depart from the contents of the technical solutions of the present application, are still within the scope of protection of the technical solutions of the present application.

Claims

1. A valve repair device, characterized in that: It includes: Main body; A capture member, 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, the capture member is provided with a leaflet limiting groove, one end of the leaflet limiting 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 limiting groove into the leaflet limiting groove; Sutures; A suture implantation assembly, comprising 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.

2. The valve repair device according to claim 1, characterized in that: 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, 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.

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 main body and the capturing 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 capturing member, one end of the connecting area of ​​the first clamping plate and the second clamping plate are both hinged to the connecting area of ​​the main body, the main body and the clamping areas of the capturing 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.

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 adjacent to the end point of the guide groove has a second slope surface, 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 adjacent to the second slope surface is also provided with an extension area 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 connecting area of ​​the capture member through a connecting rod, when the driving shaft drives the transmission shaft away from the connecting 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 to approach the connecting 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 4, characterized in that: The clamping area of ​​the main body is provided with matching parts on two opposite sides, and the matching parts 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 matching 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 is relatively closed to the main body, the ends of the first clamping piece and the second clamping piece tend to be close to the main body.

8. The valve repair device according to claim 7, characterized in that: 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.

9. The valve repair device according to claim 8, 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, and the first clamping piece and the second clamping piece are concave in shape, and 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.

10. The valve repair device according to claim 7, characterized in that: The clamping area of ​​the main body is provided with leaflet limiting surfaces on both sides of the guide groove, respectively, and the leaflet 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 leaflet limiting surfaces.

11. 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.

12. The valve repair device according to claim 6, characterized in that: 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. An open groove is also provided on the bottom surface of the main body. The open groove is used to observe the connection status of the transmission shaft and the drive shaft.

13. A valve repair device, characterized in that: It includes: Main body; A capture member, 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, the capture member is provided with a leaflet limiting groove, one end of the leaflet limiting groove is open and the other end is closed; Artificial chordae; An artificial chord implantation assembly, the artificial chord implantation assembly comprising a puncture needle and an artificial chord pushing assembly, the puncture needle can movably pass through the guide groove and puncture the leaflet in the leaflet limiting groove, and the artificial chord pushing assembly is used to push the artificial chord out of the puncture needle to reach the other side of the leaflet.

Images