Leaflet extension device

Abstract

The invention provides a valve leaflet lengthening device which comprises a conveying catheter, a first clamping arm, a second clamping arm, an opening and closing rod and a locking assembly, the first clamping arm is fixedly arranged at the far end of the conveying catheter, and the second clamping arm is rotationally connected to the near end of the first clamping arm; the opening and closing rod is connected to the near end of the second clamping arm and used for opening or closing the second clamping arm; the locking assembly comprises a blocking piece and a push rod connected with the blocking piece. The push rod is used for driving the blocking piece to move to prevent the second clamping arm from being opened. According to the valve leaflet extension device, the opening and closing rod and the locking assembly are arranged, so that the push rod drives the blocking piece to move so as to prevent the second clamping arm from being opened, and the technical problem that the second clamping arm is expanded and cocked up in the puncture process, and consequently an operation fails is solved.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular, relates to a valve leaflet extension device. Background Art

[0002] This section merely provides background information related to the present disclosure and is not necessarily prior art.

[0003] Mitral regurgitation is one of the most common heart valve diseases today. The main causes are rheumatic heart disease, myxoid degeneration of the mitral valve, ischemic heart disease, myocardial lesions, etc., which lead to lesions in the valve ring, valve leaflets, chordae tendineae and papillary muscles in the mitral valve structure, resulting in the inability of the mitral valve leaflets to close completely. Surgery is one of the effective methods for treating mitral regurgitation, but due to the large trauma caused by surgery to the human body, it is not suitable for elderly patients and patients with many complications. Most of them are now treated with minimally invasive interventional surgery, which is the better choice for most heart diseases. For mitral regurgitation, in some cases, artificial valve leaflets can be fixed on the native valve leaflets to increase the overall length of the mitral valve leaflets, so that the problem of insufficient valve leaflet apposition and incomplete closure can be solved. However, in the process of adding artificial valve leaflets to the native valve leaflets, when the native valve leaflets are punctured, there is a problem that the clamp arm is stretched and tilted during the puncture process, resulting in surgical failure. Summary of the invention

[0004] The present invention provides a valve leaflet extension device, the purpose of which is to at least solve the technical problem that the clamp arm is stretched and tilted during the puncture process, resulting in surgical failure. This purpose is achieved through the following technical solutions:

[0005] The leaflet extension device provided by the present invention comprises:

[0006] delivery catheter;

[0007] A first clamping arm, fixedly mounted on the distal end of the delivery catheter;

[0008] A second clamp arm, rotatably connected to the proximal end of the first clamp arm;

[0009] an opening and closing rod connected to the proximal end of the second clamp arm and used for opening or closing the second clamp arm;

[0010] The locking assembly comprises a blocking member and a push rod connected to the blocking member, wherein the push rod is used to drive the blocking member to move so as to prevent the second clamp arm from opening.

[0011] The leaflet extension device of the present invention is provided with a delivery catheter, a first clamp arm, a second clamp arm, an opening and closing rod and a locking assembly, so that after the first clamp arm and the second clamp arm successfully capture the native leaflet, the second clamp arm can be locked by the locking assembly before puncturing the native leaflet, thereby solving the technical problem that the second clamp arm will not be stretched and tilted by external force during the puncture process, resulting in failure of the operation.

[0012] In addition, the leaflet extension device according to the embodiment of the present invention may also have the following additional technical features:

[0013] In some embodiments of the present invention, the second clamp arm includes a pushing portion connected to the opening and closing rod, and a rotating portion extending proximally from one side of the pushing portion, and the blocking member is used to block the rotating portion from rotating to prevent the second clamp arm from opening.

[0014] In some embodiments of the present invention, the distal end of the blocking member is tapered to form an inclined surface.

[0015] In some embodiments of the present invention, a first fixing member and a second fixing member which is at a certain distance from the first fixing member are fixed to the proximal end of the opening and closing rod, a first sliding block is sleeved on the opening and closing rod, the first sliding block is arranged between the first fixing member and the second fixing member and can move axially on the opening and closing rod, and a first elastic member is also sleeved on the opening and closing rod, the first elastic member is arranged between the first fixing member and the first sliding block.

[0016] In some embodiments of the present invention, a third fixing member and a fourth fixing member at a certain distance from the third fixing member are fixed to the proximal end of the push rod, a second sliding block is sleeved on the push rod, the second sliding block is arranged between the third fixing member and the fourth fixing member and can move axially on the push rod, and a second elastic member is also sleeved on the push rod, the second elastic member is arranged between the fourth fixing member and the second sliding block.

[0017] In some embodiments of the present invention, the blocking member includes a locking block and a pushing block for pushing the locking block to move, the pushing rod is arranged at the proximal end of the pushing block, the pushing block is provided with a boss, the locking block is provided with a groove for the boss to move, the boss moves in the groove and thus drives the locking block to move, the second clamping arm includes a pushing portion connected to the opening and closing rod, and a rotating portion extending from one side of the pushing portion to the proximal end, and the locking block is used to block the pushing portion from rotating to prevent the second clamping arm from opening.

[0018] In some embodiments of the present invention, the push block includes a first sub-push block and a second sub-push block integrally formed with the first sub-push block, the boss is protruding from the second sub-push block, the locking block includes a first sub-locking block and a second sub-locking block integrally formed with the first sub-locking block, and the sum of the thicknesses of the second sub-locking block and the second sub-push block is equal to the thickness of the first sub-push block.

[0019] In some embodiments of the present invention, the first sub-locking block has a first inclined surface facing the pushing portion, the first sub-locking block also has a second inclined surface connected to the first inclined surface, the pushing portion has a third inclined surface opposite to the first inclined surface, the first inclined surface and the third inclined surface are parallel, and the second inclined surface forms a certain angle with the third inclined surface.

[0020] In some embodiments of the present invention, the leaflet extension device further comprises a plate fastener, and the plate fastener can control the opening and closing rod and the push rod to move in opposite directions.

[0021] In some embodiments of the present invention, the leaflet extension device includes a first control member and a second control member, the first control member controls the opening and closing rod to move proximally or distally, and the second control member controls the push rod to move proximally or distally. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] By reading the detailed description of the preferred embodiment below, various other advantages and benefits will become clear to those of ordinary skill in the art. The accompanying drawings are only used for the purpose of illustrating the preferred embodiment and are not considered to be limitations of the present invention. Moreover, the same reference numerals are used to represent the same components throughout the accompanying drawings.

[0023] In the attached picture:

[0024] Figure 1 The overall structural diagram of the valve leaflet extension device of the present invention is shown;

[0025] Figure 2 A schematic diagram of the exploded structure of the valve leaflet extension device of the present invention is shown;

[0026] Figure 3 A schematic diagram of the structure of the relevant components for controlling the opening and closing of the second clamping arm in the valve leaflet extension device of the present invention is shown;

[0027] Figure 4 A schematic diagram of the structure of the relevant components for controlling the movement of the blocking member in the leaflet extension device of the present invention is shown;

[0028] Figure 5 The schematic diagram of the structure of the implant anchor, artificial valve leaflet, artificial chordae and fasteners in the valve leaflet extension device of the present invention is shown;

[0029] Figure 6 The schematic diagram of the structure of the valve leaflet extension device of the present invention before the fastening member moves toward the implantation anchor and before puncture is shown;

[0030] Figure 7 A schematic diagram of the structure of the valve leaflet extension device of the present invention after the fastening member moves toward the implant anchor, i.e. after puncture;

[0031] Figure 8 The schematic diagram of the structure after the artificial valve leaflet is connected to the native valve leaflet is shown;

[0032] Fig. 9 A schematic diagram of the structure in which the second clamping arm of the valve leaflet extension device of the present invention is completely closed and locked and cannot be opened;

[0033] Fig.10 A schematic diagram of the structure of the valve leaflet extension device of the present invention when the second clamp arm is unlocked and fully opened;

[0034] Fig.11 A schematic diagram of the structure in which the first clamping arm and the second clamping arm of the valve leaflet extension device of the present invention clamp the native valve leaflet and the second clamping arm is completely closed and locked;

[0035] Fig.12 A schematic diagram showing the structure of the valve leaflet extension device of the present invention, when the first clamping arm and the second clamping arm clamp a thicker native valve leaflet, the second clamping arm is closed and locked;

[0036] Fig.13 A schematic diagram of the structure of the second clamp arm being locked after being closed in another embodiment of the leaflet extension device of the present invention is shown;

[0037] Fig.14 The structural schematic diagram of the locking block in the leaflet extension device of the present invention is shown;

[0038] Fig.15 A schematic structural diagram of a push block in the leaflet extension device of the present invention from one viewing angle is shown;

[0039] Fig.16 A schematic structural diagram of a push block in the leaflet extension device of the present invention from another perspective is shown;

[0040] Fig.17 A structural schematic diagram showing a perspective view of a locking block in the leaflet extension device of the present invention extending from a first clamp arm to block the rotation of a second clamp arm;

[0041] Fig.18 for Fig.17 A schematic diagram of the enlarged structure at A in the middle;

[0042] Fig.19A schematic structural diagram of another perspective showing that the locking block in the leaflet extension device of the present invention extends from the first clamp arm to block the rotation of the second clamp arm;

[0043] Fig. 20 A structural schematic diagram illustrating a perspective view of the valve leaflet extension device of the present invention in which the locking block is retracted into the first clamp arm to unlock the second clamp arm so that the second clamp arm can rotate;

[0044] Fig.21 A schematic structural diagram showing another perspective of the valve leaflet extension device of the present invention in which the locking block is retracted into the first clamp arm to unlock the second clamp arm so that the second clamp arm can rotate;

[0045] Fig. 22 for Fig.21 Schematic diagram of the enlarged structure at point B in the middle.

[0046] The symbols in the accompanying drawings are as follows:

[0047] 1. leaflet extension device; 10. first clamping arm; 11. first receiving groove; 20. second clamping arm; 21. through hole; 22. pushing portion; 221. third inclined surface; 23. rotating portion; 24. second receiving groove; 30. opening and closing rod; 40. blocking member; 41. inclined surface; 42. locking block; 421. groove; 422. first sub-locking block; 4221. first inclined surface; 4222. second inclined surface; 423. second sub-locking block; 43. pushing block; 431. boss; 432. first A push block; 433, a second push block; 50, a push rod; 60, a first fixing member; 61, a second fixing member; 62, a first sliding block; 63, a first elastic member; 64, a third fixing member; 65, a fourth fixing member; 66, a second sliding block; 67, a second elastic member; 70, a plate fastener; 71, a release rod; 72, a fastener; 73, an implant anchor; 74, a driving rod; 75, a driving unit; 80, a delivery catheter; 2, an artificial valve leaflet; 3, an artificial chordae; 4, a native valve leaflet. DETAILED DESCRIPTION

[0048] The exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided in order to enable a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art.

[0049] It should be understood that the terms used herein are for the purpose of describing specific example embodiments only and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "a", "an", and "said" as used herein may also be meant to include plural forms. The terms "comprise", "include", "contain", and "have" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts, and / or combinations thereof.

[0050] Although the terms first, second, third, etc. can be used in the text to describe multiple elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can only be used to distinguish an element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates, terms such as "first", "second" and other numerical terms do not imply order or sequence when used in the text. Therefore, the first element, component, region, layer or section discussed below can be referred to as the second element, component, region, layer or section without departing from the teaching of the example embodiments.

[0051] For ease of description, spatial relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figure, such as "inside", "outside", "inner side", "outer side", "below", "below", "above", "above", etc. Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure. For example, if the device in the figure is turned over, then the elements described as "below other elements or features" or "below other elements or features" will subsequently be oriented as "above other elements or features" or "above other elements or features". Therefore, the example term "below..." can include both upper and lower orientations. The device can be oriented otherwise (rotated 90 degrees or in other directions) and the spatial relative descriptors used in the text are interpreted accordingly.

[0052] It should be noted that "distal" and "proximal" are used as directional terms, which are commonly used in the field of interventional medical devices, where "distal" refers to the end away from the operator during surgery, and "proximal" refers to the end close to the operator during surgery. The direction of the central axis of rotation of an object such as a cylinder or a tube is defined as the axial direction, and the radial direction refers to the direction perpendicular to the axial direction (along the radius of the cross section).

[0053] See also Figures 1 to 8The leaflet extension device 1 of the present invention includes a delivery catheter 80, a first clamp arm 10, a second clamp arm 20, an opening and closing rod 30 and a locking assembly. The first clamp arm 10 is fixed to the distal end of the delivery catheter 80, the second clamp arm 20 is rotatably connected to the proximal end of the first clamp arm 10, the opening and closing rod 30 is connected to the proximal end of the second clamp arm 20, and is used to open or close the second clamp arm 20. The locking assembly includes a blocking member 40 and a push rod 50 connected to the blocking member 40, and the push rod 50 is used to drive the blocking member 40 to move to prevent the second clamp arm 20 from opening.

[0054] The first clamp arm 10 is provided with a first receiving groove 11, which is used to receive the buckle 72; the second clamp arm 20 is provided with a second receiving groove 24, which is used to receive the implant anchor 73, and the implant anchor 73 is pre-connected with the artificial valve leaf 2; the valve leaf extension device 1 also includes a release rod 71, which is inserted into the delivery catheter 80 and can move in the delivery catheter 80, and the distal end of the release rod 71 is used to insert the implant anchor 73 to implant the implant anchor 73. Fixed in the second accommodating groove 24 of the second clamp arm 20; the leaflet extension device 1 also includes a driving rod 74 and a driving part 75 arranged at the distal end of the driving rod 74, the driving rod 74 and the driving part 75 can move in the delivery catheter 80 and the first clamp arm 10, and the driving part 75 is provided with a limiting groove for limiting the fastening member 72, and the driving part 75 is used to move the fastening member 72 toward the implantation anchor 73 under the drive of the driving rod 74 and then fix the fastening member 72 on the implantation anchor 73. The process of extending the native leaflet 4 by the leaflet extension device 1 is roughly as follows: 1. The leaflet extension device 1 enters the heart, and when it reaches the vicinity of the target position, it opens the second clamp arm 20, and the first clamp arm 10 and the second clamp arm 20 are used to capture the native leaflet 4, and close the second clamp arm 20 after capturing it in place; 2. Figure 6 The figure shows the state where the first clamp arm 10 and the second clamp arm 20 capture the native valve leaflet 4 and then close the second clamp arm 20. At this time, the release rod 71 has fixed the implant anchor 73 in the second receiving groove 24, and then drives the driving rod 74 to move proximally. The driving rod 74 is fixedly connected to the driving part 75, so that the driving part 75 moves proximally to the position shown in FIG. Figure 7, at which time the fastener 72 is inserted into the implant anchor 73, so that the fastener 72 and the implant anchor 73 fix the native valve leaflet 4 and the artificial valve leaflet 2 together; 3. After the fastener 72 and the implant anchor 73 are fixed to each other, the release rod 71 is driven to move proximally, so that the release rod 71 is withdrawn from the implant anchor 73, and the implant anchor 73 is no longer restricted by the release rod 71 and is confined in the second accommodating groove 24, and then the second clamp arm 20 is opened, and at this time the implant anchor 73 is disengaged from the second accommodating groove 24, and the fastener 72 can also be disengaged from the first accommodating groove 11, so that the implant anchor 73 and the fastener 72 remain on the native valve leaflet 4 and the artificial valve leaflet 2, and then the second clamp arm 20 and the first clamp arm 10 are slowly withdrawn from the body, so that the artificial valve leaflet 2 can be connected to the native valve leaflet 4, as shown in FIG. Figure 8 As shown, the length of the native leaflet 4 is lengthened, which can be used to avoid the problem of insufficient leaflet coaptation height caused by insufficient leaflet length, thereby avoiding the problem of incomplete leaflet closure caused by insufficient coaptation height.

[0055] During the movement of the snap-fit ​​member 72 toward the implantation anchor 73 in the above leaflet extension device 1, when the snap-fit ​​member 72 punctures the native leaflet 4 and the artificial leaflet 2 and enters the implantation anchor 73, there is a problem that the second clamp arm 20 is stretched and tilted, resulting in the inability to accurately insert the snap-fit ​​member 72 into the implantation anchor 73, thereby causing the failure of the operation. To address this problem, the leaflet extension device 1 is provided with a locking assembly, which includes a blocking member 40 and a push rod 50 connected to the blocking member 40, and the push rod 50 is used to drive the blocking member 40 to move to prevent the second clamp arm 20 from opening. Specifically, after the first clamp arm 10 and the second clamp arm 20 successfully capture the native leaflet 4, before the snap-fit ​​member 72 moves toward the implantation anchor 73, the push rod 50 drives the blocking member 40 to move to a position that blocks the second clamp arm 20 from opening, thereby ensuring that the second clamp arm 20 will not be tilted during the puncture process, thereby improving the success rate of the operation.

[0056] Artificial chordae 3 may be pre-connected to the artificial valve leaflet 2, so that when the native chordae in the human body break and lose their function, the artificial valve leaflet 2 can achieve better opening and closing effects during the contraction and expansion periods by adding artificial chordae 3. There is no limitation on the way of setting the artificial chordae 3 on the artificial valve leaflet 2, and the artificial chordae 3 may be knotted on the artificial valve leaflet 2, or other connection methods may be used, as long as the artificial chordae 3 can be connected to the artificial valve leaflet 2 in advance.

[0057] Specifically, the delivery catheter 80 has a distal end and a proximal end. The distal end of the delivery catheter 80 may be formed with a protective head. In order to avoid damaging tissues when entering the body, the distal end surface of the protective head is preferably set to a smooth round surface. The first clamp arm 10 is fixedly arranged at the distal end of the delivery catheter 80, which may refer to that the first clamp arm 10 is fixedly connected to the distal end of the delivery catheter 80, or that the first clamp arm 10 is formed at the distal end of the delivery catheter 80. The artificial valve leaflets 2 in the present application may be understood as artificial valves, and the native valve leaflets 4 may also be understood as native valves, wherein the native valve leaflets 4 may refer to mitral valves, tricuspid valves, pulmonary valves, aortic valves, etc.

[0058] In one or more embodiments of this application, please refer to Figure 3 , Figures 9 to 12 The second clamp arm 20 includes a push portion 22 connected to the opening and closing rod 30, and a rotating portion 23 extending from one side of the push portion 22 to the proximal end. The blocking member 40 is used to block the rotating portion 23 from rotating to block the second clamp arm 20 from opening. A through hole 21 is provided at the intersection of the push portion 22 and the rotating portion 23. A rotating shaft can be provided in the through hole 21. The second clamp arm 20 can rotate around the rotating shaft to open or close the second clamp arm 20. Figure 4 The blocking member 40 is roughly in the shape of a rectangular parallelepiped. The figure is only one example. The blocking member 40 can also be a cylinder, a prism, etc. There is no limitation on it, as long as the blocking member 0 can block the rotation of the rotating part 23 when it moves to a certain position and thus block the second clamping arm 20 from opening.

[0059] Furthermore, in one embodiment, the distal end of the blocking member 40 is tapered to form an inclined surface 41. When the thickness of the native leaflet 4 clamped by the first clamp arm 10 and the second clamp arm 20 is relatively thin, such as Fig.11As shown, the second clamp arm 20 can be closed relatively horizontally, at which time the inclined surface 41 of the blocking member 40 does not contact the rotating portion 23, and the distance that the blocking member 40 moves to the distal end is relatively long. However, the thickness of each person's native leaflets is different, and some native leaflets are thicker. In order to adapt to native leaflets of different thicknesses, native leaflets of different thicknesses can be effectively captured without causing certain squeezing and damage to the native leaflets. When the native leaflets 4 clamped by the second clamp arm 20 are thicker, the second clamp arm 20 can be closed to form a certain angle with the horizontal, thereby avoiding the second clamp arm 20 still maintaining a horizontal clamping effect when clamping the thicker native leaflets 4, which is easy to cause damage to the native leaflets 4. By setting an inclined surface 41 at the distal end of the blocking member 40, when the blocking member 40 blocks the rotating part 23, the rotating part 23 can be blocked by utilizing the inclined surface 41 of the blocking member 40, that is, the rotating part 23 abuts against the inclined surface 41, thereby ensuring that the second clamping arm 20 can maintain a certain angle, while ensuring that the native leaflet 4 is stably clamped, and during the puncture process, ensuring that the second clamping arm 20 will not be further tilted, thereby improving the success rate of the operation.

[0060] In one or more embodiments of this application, please refer to Figure 3 The proximal end of the opening and closing rod 30 is fixed with a first fixing member 60 and a second fixing member 61 which is at a certain distance from the first fixing member 60. The opening and closing rod 30 is sleeved with a first sliding block 62, which is arranged between the first fixing member 60 and the second fixing member 61 and can move axially on the opening and closing rod 30. The opening and closing rod 30 is also sleeved with a first elastic member 63, which is arranged between the first fixing member 60 and the first sliding block 62. The first elastic member 63 can be a compressible silicone member or a compression spring, etc. There is no strict restriction on the specific structure of the first elastic member 63, as long as it can be compressed and can be restored to its original state after compression. Figure 3As shown, the leaflet extension device 1 also includes a plate fastener 70, which is connected to the first sliding block 62. The figure shows that the plate fastener 70 is indirectly connected to the first sliding block 62 through other connecting parts. The plate fastener 70 can control the movement of the first sliding block 62 and thereby drive the opening and closing rod 30 to move proximally or distally. Before opening the second clamp arm 20, the blocking member 40 is driven by the push rod 50 to move proximally into the delivery catheter 80 without blocking the opening of the second clamp arm 20. Then the plate fastener 70 rotates to drive the first sliding block 62 to move distally. The first sliding block 62 is arranged on the opening and closing rod 30, thereby driving the opening and closing rod 30 to move distally and thus opening the second clamp arm 20. It is then used to clamp native leaflets 4 of different thicknesses. When closing the second clamp arm 20, the plate fastener 70 rotates to drive the first sliding block 62 to move proximally, thereby driving the opening and closing rod 30 to move proximally and thus driving the second clamp arm 20 to close. After clamping the thick native leaflet 4, the second clamp arm 20 can have a certain angle with the horizontal direction when clamping (such as Fig.12 As shown in the figure, due to the provision of the first elastic member 63, the first sliding block 62 can compress the first elastic member 63 so that the first sliding block 62 can move between the first fixing member 60 and the second fixing member 61, and does not drive the opening and closing rod 30 to continue to move proximally. By providing the first elastic member 63, it is avoided that when the second clamping arm 20 clamps the thick native leaflet 4, the second clamping arm 20 is still closed to a horizontal state and the native leaflet 4 is overly compressed, thereby preventing the native leaflet 4 from being damaged.

[0061] In one or more of these embodiments, see Figure 4 ,as well as Figures 9 to 12 , a third fixing member 64 and a fourth fixing member 65 which is at a certain distance from the third fixing member 64 are fixed to the proximal end of the push rod 50, a second sliding block 66 is sleeved on the push rod 50, the second sliding block 66 is arranged between the third fixing member 64 and the fourth fixing member 65 and can move axially on the push rod 50, and a second elastic member 67 is sleeved on the push rod 50, the second elastic member 67 is arranged between the fourth fixing member 65 and the second sliding block 66. The second elastic member 67 can be a compressible silicone member or a compression spring, etc. There is no strict restriction on the specific structure of the second elastic member 67, as long as it can be compressed and can restore to its original state after compression. The leaflet extension device 1 may include a control member, so that the control member controls the movement of the second sliding block 66 and thereby drives the push rod 50 to move distally or proximally. When the second clamp arm 20 clamps the native leaflet 4 of normal thickness, the second sliding block 66 moves distally, driving the push rod 50 and the blocking member 40 to move to the farthest position, such as Fig.11In the position shown, the second clamp arm 20 clamps the native valve leaflet 4 of normal thickness, and the rotating part 23 has no squeezing force on the blocking part 40, so that the blocking part 40 can be located at the farthest position to prevent the second clamp arm 20 from tilting during the puncture process. When the second clamp arm 20 clamps the thicker native valve leaflet 4, the second sliding block 66 moves distally, driving the push rod 50 and the blocking part 40 to move distally. At this time, because the native valve leaflet 4 clamped by the second clamp arm 20 is thicker, the second clamp arm 20 has a certain angle with the horizontal direction, and the second clamp arm 20 will be slightly opened, as shown in FIG. Fig.12 As shown, at this time, the rotating portion 23 of the second clamp arm 20 has a certain squeezing force on the blocking member 40. After the squeezing force is greater than the pre-installed force of the second elastic member 67, the second elastic member 67 is compressed, causing the blocking member 40 to move a certain distance toward the proximal end, so that the rotating portion 23 abuts against the inclined surface 41 of the blocking member 40. In this way, when the second clamp arm 20 clamps the thicker native valve leaflet 4, due to the setting of the second elastic member 67, the blocking member 40 is adaptively withdrawn a certain distance toward the proximal end, thereby preventing the blocking member 40 from forcibly blocking the second clamp arm 20 to a horizontal position, and also preventing the second clamp arm 20 from forcibly pressing the native valve leaflet 4, thereby preventing the native valve leaflet 4 from being squeezed and damaged. At the same time, the blocking member 40 still maintains a blocking effect on the second clamp arm 20, thereby preventing the second clamp arm 20 from being stretched and tilted during the puncture process.

[0062] In another embodiment, see Figures 13 to 22 The blocking member 40 includes a locking block 42 and a pushing block 43 for pushing the locking block 42 to move. The push rod 50 is disposed at the proximal end of the pushing block 43. The pushing block 43 is provided with a boss 431. The locking block 42 is provided with a groove 421 for the boss 431 to move. The boss 431 moves in the groove 421 and drives the locking block 42 to move. The second clamping arm 20 includes a pushing portion 22 connected to the opening and closing rod 30, and a rotating portion 23 extending from one side of the pushing portion 22 to the proximal end. The locking block 42 is used to prevent the pushing portion 22 from rotating to prevent the second clamping arm 20 from opening. Fig.13 and Fig.19The schematic diagram shows the state of blocking the second clamp arm 20 from rotating. After the locking block 42 extends from the first clamp arm 10, it blocks the push part 22 from rotating, so that the second clamp arm 20 cannot rotate, thereby ensuring that after the first clamp arm 10 and the second clamp arm 20 successfully capture the native valve leaflet 4, before the fastening member 72 moves toward the implant anchor 73, the locking block 42 blocks the second clamp arm 20 from rotating, thereby ensuring that the second clamp arm 20 will not be stretched and tilted during the puncture process, thereby improving the success rate of the operation. The locking block 42 extends from the first clamp arm 10, and the boss 431 on the push block 43 moves in the groove 421 of the locking block 42, thereby driving the locking block 42 to extend from the first clamp arm 10 and retract into the first clamp arm 10, thereby achieving the effect that when the locking block 42 extends from the first clamp arm 10, the second clamp arm 20 can be blocked from rotating, and when it is retracted into the first clamp arm 10, the second clamp arm 20 can be smoothly rotated and opened. The movement of the push block 43 can be driven by the movement of the push rod 50 . The push rod 50 and the push block 43 can be integrally formed or fixedly connected to each other.

[0063] Furthermore, the push block 43 includes a first sub-push block 432 and a second sub-push block 433 integrally formed with the first sub-push block 432, the boss 431 is protruding from the second sub-push block 433, the locking block 42 includes a first sub-locking block 422 and a second sub-locking block 423 integrally formed with the first sub-locking block 422, and the sum of the thicknesses of the second sub-locking block 423 and the second sub-push block 433 is equal to the thickness of the first sub-push block 432. In order to make the locking block 42 and the pushing block 43 cooperate better, a first sub-push block 432, a second sub-push block 433, a first sub-locking block 422 and a second sub-locking block 423 are provided, so that the first sub-locking block 422 mainly plays the role of blocking the second clamping arm 20 from rotating, and the groove 421 of the locking block 42 is opened on the second sub-locking block 423, and the boss 431 on the second sub-push block 433 moves in the groove 421 on the second sub-locking block 423, thereby driving the entire locking block 42 to move, so as to achieve the effect of blocking the second clamping arm 20, that is, locking the second clamping arm 20, or unlocking the second clamping arm 20 so that it can be opened smoothly. The sum of the thicknesses of the second sub-locking block 423 and the second sub-pushing block 433 is equal to the thickness of the first sub-pushing block 432, so that after the boss 431 is placed in the groove 421, that is, after the second sub-pushing block 433 and the second sub-locking block 423 are stacked, the thicknesses of the second sub-pushing block 433 and the second sub-locking block 423 are the same as the thickness of the first sub-pushing block 432. In addition, the thicknesses of the second sub-pushing block 433 and the second sub-locking block 423 may also be the same as the thickness of the first sub-locking block 422, so that the overall thicknesses of the pushing block 43 and the locking block 42 are unified, which is convenient for installation, and it is convenient to leave a certain space in the first clamp arm 10 for placing the pushing block 43 and the locking block 42, thereby saving space and reducing the overall volume of the leaflet extension device 1. Figure 20 to Figure 22 The locking block 42 is in a state where it does not block the second clamp arm 20, and the locking block 42 is retracted into the first clamp arm 10, and the pushing block 43 moves to the farthest position; Figures 17 to 19 The locking block 42 is in a state of blocking the second clamping arm 20. At this time, the locking block 42 extends from the first clamping arm 10, thereby blocking the rotation of the pushing portion 22 and blocking the rotation of the second clamping arm 20. At this time, the pushing block 43 moves to the nearest position; the locking state and unlocking state of the locking block 42 can be achieved by only pushing the pushing block 43 under the action of the pushing rod 50.

[0064] Further, the first sub-locking block 422 has a first inclined surface 4221 facing the pushing portion 22, and the first sub-locking block 422 also has a second inclined surface 4222 connected to the first inclined surface 4221, and the pushing portion 22 has a third inclined surface 221 opposite to the first inclined surface 4221, the first inclined surface 4221 and the third inclined surface 221 are parallel, and the second inclined surface 4222 forms a certain angle with the third inclined surface 221. That is, the second inclined surface 4222 of the first sub-locking block 422 is gradually reduced in the direction away from the second sub-locking block 423. By providing the first sub-locking block 422 with a first inclined surface 4221 and a second inclined surface 4222, and arranging the first inclined surface 4221 to be parallel to the third inclined surface 221, and forming a certain angle between the second inclined surface 4222 and the third inclined surface 221, the first sub-locking block 422 can reach different extension degrees when extending from the first clamping arm 10. When extending, only the second inclined surface 4222 is exposed from the first clamping arm 10. At this time, the second inclined surface 4222 of the first sub-locking block 422 blocks the pushing portion 22 because the second inclined surface 4222 is 4222 and the third inclined surface 221 have a certain angle, so that the push part 22 can be slightly rotated at this time, that is, the second clamp arm 20 can be slightly opened, so that in this case, when the first clamp arm 10 and the second clamp arm 20 clamp the thicker native valve leaflet 4, it can also prevent the second clamp arm 20 from forcibly pressing the native valve leaflet 4, and prevent the native valve leaflet 4 from being squeezed and damaged, so that the second clamp arm 20 has a certain angle with the horizontal direction when it is closed, that is, the second clamp arm 20 is slightly opened, avoiding the dead pressure on the thicker native valve leaflet 4. At the same time, in this state, the first sub-locking block 422 still has a blocking effect on the second clamp arm 20, and also ensures that the second clamp arm 20 will not be tilted during the puncture process, thereby improving the success rate of the operation. When clamping the native leaflet 4 of normal thickness, the first sub-locking block 422 can make the first inclined surface 4221 and the second inclined surface 4222 simultaneously exposed from the first clamping arm 10 when extending from the first clamping arm 10. At this time, the first inclined surface 4221 of the first sub-locking block 422 blocks the push part 22, and the first inclined surface 4221 is parallel to the third inclined surface 221 of the push part 22, so that in this state, the push part 22 cannot rotate, and the second clamping arm 20 can reach a horizontal closed state when closed, ensuring the capture effect of the native leaflet 4 of normal thickness. In this way, by providing the first sub-locking block 422 with the first inclined surface 4221 and the second inclined surface 4222, the leaflet extension device 1 can clamp the native leaflets 4 of different thicknesses, which greatly improves the applicability of the device. In this embodiment, the proximal end of the push rod 50 may also be provided with a third fixing member 64, a fourth fixing member 65, a second sliding block 66 and a second elastic member 67 as described in the above embodiment to achieve the same effect as in the above embodiment, which will not be repeated here.

[0065] In one or more embodiments of the present application, the leaflet extension device 1 further includes a plate fastener 70, which can control the opening and closing rod 30 and the push rod 50 to move in opposite directions. Figure 3 and Figure 4 As shown, when controlling the movement of the opening and closing rod 30 and the push rod 50, the plate fastener 70 can be connected to both the first sliding block 62 and the second sliding block 66, so that when the control plate fastener 70 is rotated, the opening and closing rod 30 and the push rod 50 can be moved at the same time. Because the opening and closing rod 30 is used to open the second clamp arm 20, and the push rod 50 is used to block the second clamp arm 20 from opening, the movement of the two is set to opposite directions. In this way, when the opening and closing rod 30 opens the second clamp arm 20, the push rod 50 moves to a position that does not block the opening of the second clamp arm 20, and when the second clamp arm 20 is closed, the push rod 50 moves to a position that blocks the opening of the second clamp arm 20.

[0066] In one or more embodiments of the present application, the leaflet extension device 1 includes a first control member and a second control member, wherein the first control member controls the opening and closing rod 30 to move toward the proximal end or the distal end, and the second control member controls the push rod 50 to move toward the proximal end or the distal end. In order to facilitate the use of the operator and avoid confusion about the movement directions of the opening and closing rod 30 and the push rod 50, the first control member and the second control member can be respectively provided to control the movement of the opening and closing rod 30 and the push rod 50, so as to achieve the effect of opening the second clamp arm 20 or blocking the second clamp arm 20 from opening.

[0067] The above are only preferred specific embodiments of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed by the present invention should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. A leaflet extension device, characterized in that: The leaflet extension device comprises: delivery catheter; A first clamping arm is fixedly mounted on the distal end of the delivery catheter; A second clamp arm, rotatably connected to the proximal end of the first clamp arm; an opening and closing rod, connected to the proximal end of the second clamp arm and used for opening or closing the second clamp arm; The locking assembly comprises a blocking member and a push rod connected to the blocking member, wherein the push rod is used to drive the blocking member to move so as to prevent the second clamp arm from opening.

2. The leaflet extension device according to claim 1, characterized in that: The second clamp arm includes a pushing portion connected to the opening and closing rod, and a rotating portion extending from one side of the pushing portion to the proximal end, and the blocking member is used to block the rotating portion from rotating to block the second clamp arm from opening.

3. The leaflet extension device according to claim 2, characterized in that: The distal end of the blocking member is tapered to form an inclined surface.

4. The leaflet extension device according to claim 1, characterized in that: A first fixing member and a second fixing member which is at a certain distance from the first fixing member are fixed to the proximal end of the opening and closing rod. A first sliding block is sleeved on the opening and closing rod. The first sliding block is arranged between the first fixing member and the second fixing member and can move axially on the opening and closing rod. A first elastic member is also sleeved on the opening and closing rod. The first elastic member is arranged between the first fixing member and the first sliding block.

5. The leaflet extension device according to claim 1, characterized in that: A third fixing member and a fourth fixing member at a certain distance from the third fixing member are fixed to the proximal end of the push rod, a second sliding block is sleeved on the push rod, the second sliding block is arranged between the third fixing member and the fourth fixing member and can move axially on the push rod, and a second elastic member is also sleeved on the push rod, the second elastic member is arranged between the fourth fixing member and the second sliding block.

6. The leaflet extension device according to claim 1, characterized in that: The blocking member includes a locking block and a pushing block for pushing the locking block to move, the pushing rod is arranged at the proximal end of the pushing block, the pushing block is provided with a boss, the locking block is provided with a groove for the boss to move, the boss moves in the groove and thus drives the locking block to move, the second clamping arm includes a pushing portion connected to the opening and closing rod, and a rotating portion extending from one side of the pushing portion to the proximal end, the locking block is used to block the pushing portion from rotating to prevent the second clamping arm from opening.

7. The leaflet extension device according to claim 6, characterized in that: The pushing block includes a first sub-push block and a second sub-push block integrally formed with the first sub-push block, the boss is convexly arranged on the second sub-push block, the locking block includes a first sub-locking block and a second sub-locking block integrally formed with the first sub-locking block, and the sum of the thicknesses of the second sub-locking block and the second sub-push block is equal to the thickness of the first sub-push block.

8. The leaflet extension device according to claim 7, characterized in that: The first sub-locking block has a first inclined surface facing the pushing portion, and the first sub-locking block also has a second inclined surface connected to the first inclined surface. The pushing portion has a third inclined surface opposite to the first inclined surface. The first inclined surface and the third inclined surface are parallel, and the second inclined surface and the third inclined surface form a certain angle.

9. The leaflet extension device according to claim 1, characterized in that: The leaflet extension device also includes a plate fastener, which can control the opening and closing rod and the push rod to move in opposite directions.

10. The leaflet extension device according to claim 1, characterized in that: The leaflet extension device comprises a first control member and a second control member, wherein the first control member controls the opening and closing rod to move toward the proximal end or the distal end, and the second control member controls the push rod to move toward the proximal end or the distal end.

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