Artificial valve release device

Abstract

The application provides an artificial valve release device, which comprises a mounting piece and a supporting arm, the mounting piece is connected with an artificial valve leaf, the supporting arm is provided with a limiting part for limiting the mounting piece, a puncture tube is arranged in the supporting arm, an anchor and a push rod are arranged in the puncture tube, the push rod is located at the proximal end of the anchor, the puncture tube is used for puncturing the artificial valve leaf and a native valve, after the puncture is completed, the puncture tube is withdrawn into a puncture channel of the supporting arm, in the process of withdrawing the puncture tube into the puncture channel, the push rod abuts against the anchor to prevent the anchor from being withdrawn with the puncture tube, and then the anchor is penetrated out of the puncture tube, the anchor is then connected with the artificial valve leaf and the native valve after being penetrated out of the puncture tube, the mounting piece is then separated from the limiting part after being fixedly connected, the artificial valve leaf is also separated from the supporting arm along with the mounting piece, and then the artificial valve leaf and the native valve are fixedly connected, so that the technical problem that the artificial valve is difficult to be released from the device and connected to the native valve is solved.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to an artificial valve release device. Background Technology

[0002] This section provides only background information relevant to this disclosure and is not necessarily prior art.

[0003] Natural heart valves (namely, the aortic valve, pulmonary valve, tricuspid valve, and mitral valve) play a crucial role in ensuring an adequate supply of blood through the cardiovascular system. These valves can become less effective due to congenital malformations, inflammatory processes, infectious conditions, or diseases. Treatment for such conditions can involve surgical repair or replacement of the valves through open-heart surgery, or the introduction and implantation of prosthetic devices using transcatheter or transapical techniques, which are far less invasive than open-heart surgery.

[0004] The heart's natural mitral valve connects the left atrium to the left ventricle. The mitral valve consists of an annulus and a pair of leaflets. The annulus is the natural valve tissue surrounding the mitral orifice, and the leaflets extend downwards from the annulus into the left ventricle. However, some valves fail to close properly during the systolic phase of heart contraction, causing valvular regurgitation (regurgitation) as blood flows from the left ventricle into the left atrium. Mitral regurgitation has various causes, and some solutions involve adding artificial leaflets to the natural mitral valve leaflets to ensure complete closure of the leaflets and prevent regurgitation. However, when adding artificial leaflets to the natural leaflets, the artificial leaflets are difficult to remove from the device and may not connect smoothly to the natural leaflets. Summary of the Invention

[0005] This invention provides an artificial valve release device, aiming to at least solve the technical problem of the difficulty in detaching an artificial valve from a medical device and connecting the artificial valve to a natural valve. This objective is achieved through the following technical solution:

[0006] The artificial valve release device provided by the present invention includes:

[0007] An installation component, on which an artificial leaflet is connected;

[0008] The support arm has a limiting part at its distal end for limiting the position of the mounting component. The support arm supports the native valve through the mounting component. The support arm contains a puncture tube and a puncture channel for the puncture tube to pass through. The puncture tube can pass through the puncture channel and then sequentially pass through the mounting component, the artificial valve leaflet, and the native valve. The puncture tube contains an anchor and a push rod. The push rod is located at the proximal end of the anchor. When the puncture tube punctures the artificial valve leaflet and the native valve and is withdrawn into the puncture channel, the push rod is used to press against the anchor to push the anchor out of the puncture tube. After the anchor is pushed out of the puncture tube, it is used to fix the artificial valve leaflet and the native valve together.

[0009] The artificial valve release device of the present invention comprises an installation component and a support arm. The installation component is connected to an artificial valve leaflet, and the support arm has a limiting part for limiting the installation component. A puncture tube is provided inside the support arm, and an anchor and a push rod are provided inside the puncture tube. The push rod is located at the proximal end of the anchor. The puncture tube is used to puncture the artificial valve leaflet and the native valve. After the puncture is completed, the puncture tube is withdrawn into the puncture channel of the support arm. During the withdrawal of the puncture tube into the puncture channel, the push rod presses against the anchor, preventing the anchor from withdrawing with the puncture tube, thereby allowing the anchor to pass through the puncture tube. After the anchor passes through the puncture tube, it fixes the artificial valve leaflet and the native valve together. After the fixation, the installation component detaches from the limiting part, and the artificial valve leaflet also detaches from the support arm along with the installation component, thereby fixing the artificial valve leaflet and the native valve together. This solves the technical problem that it is difficult to detach the artificial valve from the device and connect the artificial valve to the natural valve.

[0010] In addition, the artificial valve release device according to embodiments of the present invention may also have the following additional technical features:

[0011] In some embodiments of the present invention, the anchoring element includes an anchor wire and a clip fixedly connected to the proximal end of the anchor wire. The anchor wire includes a disc-shaped segment and a straight segment connected to the proximal end of the disc-shaped segment. The clip is fixedly connected to the proximal end of the straight segment. The puncture tube and the support arm are provided with a groove for the clip to pass through.

[0012] In some embodiments of the present invention, the limiting part is a rotating member, which is rotatably connected to the supporting arm. The rotating member includes a protruding part and a locking part for engaging with the mounting member. The mounting member has a slot for the protruding part to be inserted into, and the locking part engages with the slot wall of the slot.

[0013] In some embodiments of the present invention, the mounting member includes a support plate and a support column disposed at an obtuse angle to the support plate, and the slot is formed in the support column.

[0014] In some embodiments of the present invention, the limiting part is a limiting groove formed on the support arm, the mounting member has a puncture hole for the puncture tube to pass through, the mounting member has a groove for the distal end of the support arm to be inserted, the groove wall of the groove is formed with a first inclined surface, and the groove wall of the limiting groove is formed with a second inclined surface for cooperating with the first inclined surface.

[0015] In some embodiments of the present invention, the groove is a U-shaped groove.

[0016] In some embodiments of the present invention, the limiting part is a fixing tube sleeved on the outer periphery of the puncture tube, the mounting member has an assembly hole that is interference-fitted with the fixing tube, and the proximal end face of the mounting member is parallel to the distal end face of the support arm.

[0017] In some embodiments of the present invention, the mounting member includes a support plate that conforms to the artificial leaflet and a mating post extending from one side of the support plate.

[0018] In some embodiments of the present invention, the mounting component is provided with fixing holes for connecting with artificial leaflets.

[0019] In some embodiments of the present invention, after the anchoring member extends from the puncture tube, it secures the original valve, the artificial valve leaflet, and the mounting member between the disc segment and the clip. Attached Figure Description

[0020] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Furthermore, the same reference numerals denote the same parts throughout the drawings.

[0021] In the attached diagram:

[0022] Figure 1 This diagram illustrates the structure of the mounting component being fixed and limited to the support arm in the first embodiment of the artificial valve release device of the present invention.

[0023] Figure 2 This diagram illustrates the installation structure of the mounting component, artificial valve leaflet, and rotating component in the first embodiment of the artificial valve release device of the present invention.

[0024] Figure 3 This diagram illustrates a cross-sectional view of the installation component being fixed to the support arm in the first embodiment of the artificial valve release device of the present invention.

[0025] Figure 4This diagram illustrates the structure of the puncture tube puncturing distally in the first embodiment of the artificial valve release device of the present invention.

[0026] Figure 5 This diagram illustrates the structure of the artificial valve release device of the present invention, showing the puncture tube being retracted into the puncture channel in the first embodiment.

[0027] Figure 6 This diagram illustrates the structure after puncture and anchoring is completed in the first embodiment of the artificial valve release device of the present invention.

[0028] Figure 7 This diagram illustrates the structure of the mounting component being fixed to the support arm in the second embodiment of the artificial valve release device of the present invention.

[0029] Figure 8 This diagram illustrates the structure between the mounting component and the support arm in the second embodiment of the artificial valve release device of the present invention.

[0030] Figure 9 This diagram illustrates a cross-sectional view of the installation component being fixed to the support arm in the second embodiment of the artificial valve release device of the present invention.

[0031] Figure 10 This diagram illustrates the structure of the puncture tube puncturing distally in the second embodiment of the artificial valve release device of the present invention.

[0032] Figure 11 This diagram illustrates the structure of the second embodiment of the artificial valve release device of the present invention, showing the puncture tube being retracted into the puncture channel.

[0033] Figure 12 This diagram illustrates the structure of the artificial valve release device of the present invention, showing the installation component detaching from the support arm in the second embodiment.

[0034] Figure 13 This diagram illustrates the structure after puncture and anchoring in the second embodiment of the artificial valve release device of the present invention.

[0035] Figure 14 This diagram illustrates the structure of the mounting component being fixed to the support arm in the third embodiment of the artificial valve release device of the present invention.

[0036] Figure 15 This diagram illustrates the structure between the mounting component and the support arm in the third embodiment of the artificial valve release device of the present invention.

[0037] Figure 16 This diagram illustrates a cross-sectional view of the installation component being fixed to the support arm in the third embodiment of the artificial valve release device of the present invention.

[0038] Figure 17This diagram illustrates the structure of the puncture tube puncturing distally in the third embodiment of the artificial valve release device of the present invention.

[0039] Figure 18 This diagram illustrates the structure of the artificial valve release device of the present invention in the third embodiment, showing the puncture tube being retracted into the puncture channel.

[0040] Figure 19 This diagram illustrates the structure after puncture and anchoring is completed in the third embodiment of the artificial valve release device of the present invention.

[0041] Figure 20 This diagram illustrates the structure of the artificial valve release device of the present invention as it enters the heart.

[0042] The markings in the attached diagram are as follows:

[0043] 1. Artificial valve release device; 10. Support arm; 11. Puncture channel; 12. Puncture tube; 13. Anchor; 131. Anchor wire; 131a. Disc-shaped segment; 131b. Straight segment; 132. Locking element; 14. Push rod; 15. Slide groove; 16. Rotating element; 161. Protruding part; 162. Locking part; 163. Rotating hole; 17. Limiting groove; 171. Second inclined surface; 18. Fixing tube; 20. Installation part; 21. Locking groove; 22. Support plate; 23. Support column; 24. Puncture hole; 25. Groove; 251. First inclined surface; 26. Support plate; 27. Matching column; 28. Assembly hole; 29. ​​Fixing hole; 3. Artificial valve leaflet; 4. Native valve; 5. Native chordae tendineae; 6. Papillary muscle. Detailed Implementation

[0044] Exemplary embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

[0045] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also mean including the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof.

[0046] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0047] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would 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 may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0048] It should be noted that the terms "distal" and "proximal" are used as directional terms, which are commonly used in the field of interventional medical devices. "Distal" refers to the end furthest from the operator during the procedure, while "proximal" refers to the end closest to the operator. The direction of the rotational axis of objects such as cylinders and tubes is defined as the axial direction, and the radial direction refers to the direction perpendicular to the axial direction (along the cross-sectional radius).

[0049] Please see Figures 1 to 20The artificial valve release device 1 of the present invention includes an mounting component 20 and a support arm 10. An artificial valve leaflet 3 is pre-connected to the mounting component 20. The distal end of the support arm 10 is provided with a limiting portion for limiting the mounting component 20. The support arm 10 is used to support the native valve 4 through the mounting component 20. A puncture tube 12 is provided inside the support arm 10, and a puncture channel 11 is opened inside the support arm 10 for the puncture tube 12 to pass through. The puncture tube 12 can then pass through the puncture channel 11. The puncture tube 12 passes sequentially through the mounting component 20, the artificial valve leaflet 3, and the native valve 4. An anchor 13 and a push rod 14 are provided inside the puncture tube 12. The push rod 14 is located near the end of the anchor 13. When the puncture tube 12 punctures the artificial valve leaflet 3 and the native valve 4 and is withdrawn into the puncture channel 11, the push rod 14 is used to hold the anchor 13 to push the anchor 13 out of the puncture tube 12. After the anchor 13 is pushed out of the puncture tube 12, it is used to fix the artificial valve leaflet 3 and the native valve 4.

[0050] Specifically, an artificial valve leaflet 3 is pre-connected to the mounting component 20. The limiting portion at the distal end of the support arm 10 can limit the mounting component 20, initially restricting the mounting component 20 and the artificial valve leaflet 3 to the distal end of the support arm 10. Once the support arm 10 restricts the mounting component 20 to its distal end via the limiting portion, the support arm 10 can then support the native valve 4 (e.g., [missing information]) through the mounting component 20 and the artificial valve leaflet 3. Figure 3 , Figure 9 and Figure 16 (As shown). This can be understood as follows: intact, non-prolapsed native chordae tendineae 5 are connected to each native valve 4. Please refer to... Figure 20One end of the native chordae tendineae 5 is connected to the native valve 4, and the other end of the native chordae tendineae 5 is connected to the papillary muscle 6 of the heart. The native chordae tendineae 5 has a certain traction effect on the native valve 4, so that when the support arm 10 supports the native valve 4, the puncture tube 12 can complete the puncture of the artificial leaflet 3 and the native valve 4. After supporting the native valve 4, the puncture tube 12 located in the puncture channel 11 can pass out from the puncture channel 11 and pass through the mounting component 20, the artificial valve leaflet 3 and the native valve 4 in sequence. The puncture tube 12 is provided with an anchor 13 and a push rod 14. The push rod 14 is located at the proximal end of the anchor 13. When the puncture tube 12 has punctured the artificial valve leaflet 3 and the native valve 4, during the process of withdrawing the puncture tube 12 back to the puncture channel 11, the push rod 14 pushes against the anchor 13 so that the anchor 13 does not withdraw to the proximal end with the puncture tube 12, thereby causing the anchor 13 to be pushed out from the puncture tube 12. After the anchor 13 passes out from the puncture tube 12, it fixes the artificial valve leaflet 3 and the native valve 4. After the fixed connection, the mounting piece 20 detaches from the limiting part, and the artificial leaflet 3 also detaches from the support arm 10 along with the mounting piece 20. This allows the anchoring piece 13 to fix the native valve 4, the artificial leaflet 3, and the mounting piece 20 together, solving the technical problem of the difficulty in detaching the artificial valve from the device and connecting it to the natural valve. Simultaneously, by increasing the length of the artificial leaflet on the native valve, the problem of incomplete leaflet closure caused by excessively short leaflets is solved. Furthermore, by fixing the artificial leaflet on the native valve, the problem of mitral valve leaflet closure insufficiency caused by ventricular dilation leading to annular enlargement can also be solved, thereby regurgitation caused by mitral valve leaflet closure insufficiency during ventricular systole. In this application, the artificial leaflet can be understood as an artificial valve, and the native valve can also be understood as the native leaflet. The native valve can refer to the mitral valve, tricuspid valve, pulmonary valve, aortic valve, etc. Alternatively, artificial chordae tendineae can be pre-connected to the artificial leaflets. When chordae tendineae prolapse and artificial chordae tendineae need to be added, artificial chordae tendineae can be added at the same time as artificial leaflets.

[0051] Furthermore, the anchoring component 13 includes an anchoring wire 131 and a clamping component 132 fixedly connected to the proximal end of the anchoring wire 131. The anchoring wire 131 includes a disc-shaped segment 131a and a straight segment 131b connected to the proximal end of the disc-shaped segment 131a. The clamping component 132 is fixedly connected to the proximal end of the straight segment 131b. The puncture tube 12 and the support arm 10 are provided with a groove 15 for the clamping component 132 to pass through. The clamping component 132 and the anchoring wire 131 can be fixedly connected by welding, crimping, bonding, or other methods. The anchor wire 131 is a shape memory alloy wire, such as nickel-titanium wire, which can be shaped by nickel-titanium. In the free state, the disc-shaped segment 131a of the anchor wire 131 will unfold into a large-area ring, which plays a limiting role. When the disc-shaped segment 131a is in the assembled state, that is, when it is located in the puncture tube 12, the disc-shaped segment 131a can be extended into a straight wire and placed in the puncture tube 12. The straight segment 131b of the anchor wire 131 is a straight wire in both the free state and when it is located in the puncture tube 12. After the puncture cannula 12 passes through the puncture channel 11 to puncture the artificial valve leaflet 3 and the original valve 4, during the puncture process, the anchor 13 and the push rod 14 move distally along with the puncture cannula 12 to complete the puncture. After the puncture is completed, the puncture cannula 12 retracts proximally. During the proximal retraction of the puncture cannula 12, the anchor 13 does not retract with the puncture cannula 12, but is held in place by the push rod 14, which keeps the anchor 13 and the push rod 14 in place. Alternatively, the push rod 4 can be controlled to push the anchor 13 distally as needed. After withdrawal, because the anchor 13 remains stationary, or because the anchor 13 moves a certain distance distally under the push of the push rod 14, the anchor 13 exits from the puncture tube 12, causing the disc-shaped segment 131a of the anchor wire 131 to be released and become a free disc, anchored to the native valve 4. The straight segment 131b then passes through the artificial leaflet 3 and the mounting piece 20. Finally, the anchor 13 fixes the native valve 4, the artificial leaflet 3, and the mounting piece 20 between its disc-shaped segment 131a and the clamp 132, completing the fixed connection of the native valve 4 and the artificial leaflet 3 (e.g., Figure 6 , Figure 13 and Figure 19 (As shown). The puncture tube 12 and the support arm 10 are provided with grooves 15 for the clamp 132 to pass through. This allows the clamp 132 and the puncture tube 12 to move smoothly relative to the support arm 10 when they move simultaneously distally. Simultaneously, when the puncture tube 12 is withdrawn proximally, the clamp 132 can also move relative to the puncture tube 12 within the tube. To ensure better fit between the native valve 4, the artificial leaflet 3, and the mounting member 20, the sum of the thickness of the native valve 4, the thickness of the artificial leaflet 3, and the length between the proximal and distal ends of the mounting member 20 can be set equal to the length of the straight segment 131b of the anchor wire 131.

[0052] Example 1

[0053] Please see Figures 1 to 6 A limiting part located at the distal end of the support arm 10 is a rotating member 16. The rotating member 16 is rotatably connected to the support arm 10. The rotating member 16 includes a protruding part 161 and a locking part 162 for engaging with the mounting member 20. The mounting member 20 has a slot 21 for inserting the protruding part 161, and the locking part 162 engages with the groove wall of the slot 21. Figure 2 As shown, the mounting component 20 has fixing holes 29, which are used to pre-connect the artificial valve leaflet 3 to the mounting component 20. The artificial valve leaflet 3 and the mounting component 20 can be fixed together by sewing, or by bonding or other methods. There are no strict restrictions on the connection method, as long as it can be fixed. One or more support arms 10 can be provided. Figure 1 The support arm 10 shown has three parts. When there are multiple support arms 10, multiple support arms 10 can jointly support an artificial leaflet 3. At the same time, multiple anchoring elements 13 can be anchored on an artificial leaflet 3 and a native valve 4, so that the connection between the artificial leaflet 3 and the native valve 4 is more fixed. Figure 1 The diagram shows the mounting component 20 and the artificial leaflet 3 being positioned on the support arm 10. The rotating component 16 is rotatably connected to the support arm 10. A rotating hole 163 can be provided on the rotating component 16, and a hole coaxial with the rotating hole 163 can be provided on the support arm 10. Then, a pin or rotating shaft can be inserted into the rotating hole 163 and the hole on the support arm 10, so that the rotating component 16 is rotatably connected to the support arm 10.

[0054] Furthermore, when the mounting component 20 is constrained on the support arm 10, such as Figure 3 As shown, the protruding part 161 of the rotating part 16 is inserted into the slot 21 of the mounting part 20, and the locking part 162 of the rotating part 16 overlaps the groove wall of the slot 21, so that both the protruding part 161 and the locking part 162 are locked into the slot 21, thereby fixing the mounting part 20 and the artificial petiole 3 on the support arm 10. Figure 4 As shown, after the puncture tube 12 exits from the puncture channel 11, it passes sequentially through the mounting component 20, the artificial valve leaflet 3, and the native valve 4. When passing through the mounting component 20, the puncture tube 12 pushes open the protrusion 161, causing the protrusion 161 to rotate and disengage from the slot 21. The locking part 162 also disengages from the slot 21 and no longer overlaps the slot wall. This allows the mounting component 20 to be released freely, no longer confined to the support arm 10. Please refer to... Figure 5As shown, after the puncture tube 12 is inserted, during the process of withdrawing it to the puncture channel 11, the push rod 14 and the anchor 13 remain stationary and do not retract with the puncture tube 12. The push rod 14 presses against the locking piece 132 of the anchor 13, and the push rod 14 can also be controlled to push the locking piece 132 distally. As the puncture tube 12 is withdrawn from the puncture channel 11, the disc-shaped segment 131a of the anchor wire 131 is freed from the restriction of the puncture tube 12 and freely releases and unfolds above the original valve 4. The disc-shaped anchor wire 131 has a straight segment 131b that passes through the native valve 4, the artificial leaflet 3, and the mounting element 20. Then, the disc-shaped segment 131a of the anchor wire 131 engages with the locking piece 132 below the mounting element 20 to anchor the native valve 4 and the artificial leaflet 3. Simultaneously, the mounting element 20 detaches from the support arm 10, and the artificial leaflet 3 also detaches from the support arm 10 along with the mounting element 20, solving the problem of the artificial valve being difficult to detach from the device. After the puncture and anchoring are completed... Figure 6 As shown, the anchor 13 and the mounting part 20 are left inside the body to fix the original valve 4 and the artificial leaflet 3, which further realizes the connection of the artificial leaflet to the original valve to solve the problem of incomplete leaflet closure caused by the leaflet being too short.

[0055] Furthermore, the mounting component 20 includes a support plate 22 and a support column 23 set at an obtuse angle to the support plate 22, with a slot 21 formed on the support column 23. The support plate 22 increases the contact area between the mounting component 20 and the artificial leaflet 3, making the connection more stable. After the anchoring component secures the original valve 4, the artificial leaflet 3, and the mounting component 20 together, the larger contact area between the mounting component 20 and the artificial leaflet 3 during leaflet movement prevents tearing forces and protects the artificial leaflet 3 from damage. The obtuse angle between the support column 23 and the support plate 22 allows the slot 21 on the support column 23 to better engage with the rotating component 16, while the support plate 22 also provides better support to the distal end of the support arm 10.

[0056] Example 2

[0057] Please see Figures 7 to 13 The limiting part is a limiting groove 17 formed on the support arm 10. The mounting part 20 has a piercing hole 24 for the piercing tube 12 to pass through, and a groove 25 for the distal end of the support arm 10 to be inserted. The groove wall of the groove 25 is formed with a first inclined surface 251, and the groove wall of the limiting groove 17 is formed with a second inclined surface 171 for cooperating with the first inclined surface 251. Figure 7 and Figure 8The diagram illustrates that there are multiple support arms 10, specifically three, and the corresponding number of mounting parts 20 is also three. This allows for the anchoring of anchoring parts 13 and mounting parts 20 at three locations on the artificial leaflet 3 and the native valve 4, resulting in a more stable connection between the artificial leaflet 3 and the native valve 4. Figure 7 The diagram shows the overall configuration of the mounting component 20 and the artificial leaflet 3 initially being fixedly connected to the support arm 10. Figure 8 The diagram shown is an exploded view of the structure between the mounting component 20 and the support arm 10.

[0058] The release process of artificial valve release device 1 is roughly as follows: Please refer to Figure 9 The distal end of the puncture tube 12 is initially inserted into the puncture hole 24 at the proximal end of the mounting member 20 and into the distal end of the support arm 10, thus initially limiting and fixing the mounting member 20 to be connected to the support arm 10. A groove 25 is provided on the mounting member 20 for the distal end of the support arm 10 to be inserted, while the first inclined surface 251 and the second inclined surface 171 are in contact. Then please refer to the connection... Figure 10 The puncture cannula 12 is inserted distally, passing through the artificial valve leaflet 3 and the original valve 4. During the distal insertion of the puncture cannula 12, the push rod 14 and the anchor 13 also move distally synchronously with the puncture cannula 12; please refer to Figure 11 After the puncture tube 12 is inserted, it is retracted into the puncture channel 11 of the support arm 10. During the retraction of the puncture tube 12, the push rod 14 and the anchoring element 13 remain stationary and do not retract with the puncture tube 12. The push rod 14 presses against the locking piece 132 of the anchoring element 13. Alternatively, the push rod 14 can be controlled to push the locking piece 132 distally. As the puncture tube 12 is retracted into the puncture channel 11, the disc-shaped segment 131a of the anchoring wire 131, freed from the restriction of the puncture tube 12, freely releases and unfolds into a disc ring above the native valve 4. The straight segment 131b of the anchoring wire 131 passes through the native valve 4, the artificial leaflet 3, and the mounting element 20. Then, the disc-shaped segment 131a of the anchoring wire 131 engages with the locking piece 132 below the mounting element 20 to complete the anchoring of the native valve 4 and the artificial leaflet 3. Please refer to [link to relevant documentation]. Figure 12 Guided by the first inclined plane 171 and the second inclined plane 251, the valve slides away from the support arm 10, thus releasing the mounting piece 20 and the artificial valve leaflet 3 from the support arm 10, solving the problem of the artificial valve being difficult to detach from the device. After puncture and anchoring... Figure 13 As shown, the anchor 13 and the mounting part 20 are left inside the body to fix the original valve 4 and the artificial leaflet 3, which further realizes the connection of the artificial leaflet to the original valve to solve the problem of incomplete leaflet closure caused by the leaflet being too short.

[0059] By directly creating a limiting groove 17 on the support arm 10, the mounting component 20 is initially confined within the support arm 10, avoiding the need for additional components, saving space and instrument weight, and reducing the volume and weight of the artificial valve release device 1, thus facilitating operation and surgery. Furthermore, by forming a first inclined surface 251 on the groove wall of the mounting component 20's groove 25, and a second inclined surface 171 on the groove wall of the limiting groove 17 that mates with the first inclined surface, the mounting component 20 can simply slide away from the support arm 10 under the guidance of these two inclined surfaces when detaching. Furthermore, the groove on the mounting component is a U-shaped groove, which helps the distal end of the support arm 10 to smoothly insert into the groove 25, making operation even more convenient.

[0060] Example 3

[0061] Please see Figures 14 to 19 The limiting part is a fixing tube 18 sleeved around the puncture tube 12. The mounting part 20 has an assembly hole 28 that is interference-fitted with the fixing tube 18. The proximal end face of the mounting part 20 is parallel to the distal end face of the support arm 10. The mounting part 20 has a fixing hole 29 for connecting with the artificial valve leaflet 3. The artificial valve leaflet 3 is pre-connected to the mounting part 20 through the fixing hole 29. Figure 14 and Figure 15 The illustration shows that there are multiple support arms 10, specifically three, and the corresponding number of mounting parts 20 is also three. This allows for the anchoring of anchoring parts 13 and mounting parts 20 at three locations on the artificial leaflet 3 and the native valve 4, making the connection between the artificial leaflet 3 and the native valve 4 more stable. Figure 14 The diagram shows the overall configuration of the mounting component 20 initially fixedly connected to the support arm 10, with the artificial leaflet 3 fixedly connected to the mounting component 20; as shown Figure 15 The diagram shows the connection between the mounting component 20 and the support arm 10. The diagram shows that there are three support arms 10 and three corresponding mounting components 20. To more clearly show the relationship between the mounting component 20 and the support arm 10, the mounting component is not shown on one of the support arms 10.

[0062] The release process of the artificial valve release device 1 in this embodiment is roughly as follows: Please refer to Figure 16This is a schematic diagram showing the initial positioning and fixing of the mounting component 20 to the support arm 10. The fixing tube 18 is located within the puncture channel 11 of the support arm 10, and is sleeved around the outer periphery of the puncture tube 12. The distal end of the fixing tube 189 is inserted into the assembly hole 28 of the mounting component 20. Here, the fixing tube 18 and the assembly hole 28 of the mounting component 20 are interference-fitted, which does not mean that they cannot be separated, but that there is a certain tightness between them. The mounting component 20 cannot be easily detached from the fixing tube 18. The mounting component 20 has a fixing hole 29 for connecting with the artificial leaflet 3. The artificial leaflet 3 is pre-connected to the mounting component 20 through the fixing hole 29. Please refer to [link to relevant documentation]. Figure 17 The puncture cannula 12 is inserted distally, passing through the artificial valve leaflet 3 and the original valve 4. During the distal insertion of the puncture cannula 12, the push rod 14 and the anchor 13 also move distally synchronously with the puncture cannula 12; please refer to Figure 18 After the puncture tube 12 is inserted, it is withdrawn into the puncture channel 11 of the support arm 10. During the withdrawal of the puncture tube 12, the push rod 14 and the anchor 13 remain stationary and do not withdraw with the puncture tube 12. The push rod 14 presses against the locking piece 132 of the anchor 13. Alternatively, the push rod 14 can be controlled to push the locking piece 132 distally. As the puncture tube 12 is withdrawn into the puncture channel 11, the disc-shaped segment 131a of the anchor wire 131, freed from the restriction of the puncture tube 12, freely releases and unfolds into a disc ring above the native valve 4. The straight segment 131b of 131 passes through the native valve 4, the artificial leaflet 3, and the mounting component 20. The puncture tube 12 is withdrawn into the puncture channel 11, and then the fixation tube 18 is controlled to retract proximally, that is, the distal end of the fixation tube 18 is withdrawn from the mounting component 20 into the puncture channel 11 of the support arm 10, because the proximal end face of the mounting component 20 is parallel to the distal end face of the support arm 10. Then the disc-shaped segment 131a of the anchor wire 131 cooperates with the clip 132 below the mounting component 20 to complete the anchoring of the native valve 4 and the artificial leaflet 3. Because the proximal face of the mounting component 20 is parallel to the distal face of the support arm 10, when the fixing tube 18 is retracted proximally, the distal face of the support arm 20 abuts against the proximal face of the mounting component 20, keeping the support arm 10 and the mounting component 20 stationary. This allows the fixing tube 18 to detach from the assembly hole 18 and retract into the puncture channel 11. Thus, the mounting component 20 is no longer restricted by the fixing tube 18, and it is released from the support arm 10. The artificial valve leaflet 3 is also released from the support arm 10, solving the problem of the artificial valve being difficult to detach from the instrument. After both the puncture tube 12 and the fixing tube 18 are retracted into the puncture channel 11, the disc-shaped segment 131a of the anchor wire 131 engages with the clip 131 below the mounting component 20 to complete the anchoring of the native valve 4 and the artificial valve leaflet 3. Figure 19As shown, after the puncture and anchoring are completed, the anchoring member 13 and the mounting member 20 are left in the body to jointly fix the native valve 4 and the artificial leaflet, further realizing the connection of the artificial leaflet 3 to the native valve 4 to solve the problem of incomplete leaflet closure caused by the leaflet being too short. Furthermore, the mounting member 20 includes a support plate 26 that fits against the artificial leaflet 3 and a mating post 27 extending from one side of the support plate 26. The support plate 26 increases the contact area between the mounting member 20 and the artificial leaflet 3, making the connection more stable. After the anchoring member 13 fixes the native valve 4, the artificial leaflet 3, and the mounting member 20 together, the larger contact area between the mounting member 20 and the artificial leaflet 3 during leaflet movement avoids tearing forces on the artificial leaflet 3, protecting it from damage. At the same time, the setting of the column 27 better matches the far end of the support arm 10, making it easier to limit and fix the mounting part 20 to the support arm 10 at the beginning, and after the puncture is completed, the mounting part 20 can also be easily detached from the support arm 10.

[0063] The above are merely preferred embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in the present invention should be included within the scope of protection of the present invention.

Claims

1. A prosthetic valve deblocking device, comprising: The artificial valve relief device comprises: a mounting member to which an artificial valve leaflet is connected; a supporting arm, a distal end of which is provided with a limiting part for limiting the mounting member, the supporting arm being used for supporting a native valve through the mounting member, a puncture tube being arranged in the supporting arm, a puncture channel being formed in the supporting arm for the puncture tube to pass through, the puncture tube being capable of sequentially passing through the mounting member, the artificial valve leaflet and the native valve after being punctured out of the puncture channel, an anchor and a push rod being arranged in the puncture tube, the push rod being located at a proximal end of the anchor, the push rod being used for pushing the anchor to be punctured out of the puncture tube when the puncture tube is withdrawn into the puncture channel after puncturing the artificial valve leaflet and the native valve, the anchor being used for fixedly connecting the artificial valve leaflet and the native valve after being punctured out of the puncture tube. The anchor comprises an anchor wire and a clamping member fixedly connected to a proximal end of the anchor wire, the anchor wire comprising a disc-shaped section and a straight section connected to a proximal end of the disc-shaped section, the clamping member being fixedly connected to a proximal end of the straight section, a sliding groove being formed in the puncture tube and the supporting arm for the clamping member to pass through. The anchor is fixedly connected between the disc-shaped section and the clamping member after being punctured out of the puncture tube.

2. The prosthetic valve liberation device of claim 1, wherein, The limiting part is a rotating member, the rotating member being rotatably connected to the supporting arm, the rotating member comprising a convex blocking part and a clamping part used for clamping the mounting member, a clamping groove being formed in the mounting member for the convex blocking part to insert into, the clamping part being clamped to a groove wall of the clamping groove.

3. The prosthesis release device of claim 2, wherein the at least one flexible member is a wire. The mounting member comprises a supporting plate and a supporting column arranged at an obtuse angle with the supporting plate, the clamping groove being formed in the supporting column.

4. The prosthetic valve liberation device according to claim 1, characterized in that The limiting part is a limiting groove formed in the supporting arm, a puncture hole being formed in the mounting member for the puncture tube to pass through, a recess being formed in the mounting member for the distal end of the supporting arm to insert into, a first inclined surface being formed on a groove wall of the recess, a second inclined surface being formed on a groove wall of the limiting groove for cooperating with the first inclined surface.

5. The prosthetic valve liberation device according to claim 4, characterized in that The recess is a U-shaped groove.

6. The prosthetic valve liberation device according to claim 1, wherein, The limiting part is a fixing tube sleeved on an outer periphery of the puncture tube, an assembly hole being formed in the mounting member for interference fit with the fixing tube, a proximal end surface of the mounting member being parallel to a distal end surface of the supporting arm.

7. The prosthetic valve liberation device according to claim 6, characterized in that The mounting member comprises a supporting plate abutting the artificial valve leaflet and a cooperating column extending from one side of the supporting plate.

8. The prosthetic valve liberation device according to claim 1, wherein, A fixing hole is formed in the mounting member for connecting with the artificial valve leaflet.

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