Artificial heart valve and implantation and recovery method of positioning key of artificial heart valve

Abstract

The invention relates to the technical field of medical instruments, and discloses an artificial heart valve and an implantation and recovery method of an artificial heart valve positioning key, the artificial heart valve comprises a valve stent, a positioning key and a connecting mechanism; the connecting mechanism comprises a sliding assembly connecting line and an auxiliary recovery connecting line; one end of the sliding assembly connecting line is fixed to the valve support, and the other end of the sliding assembly connecting line is in sliding connection with the positioning key. The auxiliary recovery connecting line is connected with the positioning key and the valve stent and is configured to be pushed by the end part of the outer sheath tube to pull the positioning key to be recovered into the outer sheath tube; when the positioning key is released, the positioning key is configured to slide towards the far end of the valve stent along the outer layer of the valve stent under the action of the assembly connecting wire to complete self-assembly; or the auxiliary recovery connecting line is configured to be pushed by the end part of the outer sheath tube so as to force the positioning key to slide towards the far end of the valve stent along the outer layer of the valve stent to finish assembly. Open type self-assembly is adopted in the device, meanwhile, external force application assembly is compatible, and the positioning key can be recycled after being completely released.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to an implantation and retrieval method of an artificial heart valve and an artificial heart valve positioning key. Background Art

[0002] In the field of transcatheter aortic valve replacement (TAVR) for treating aortic valve regurgitation, the aortic valve positioning key is mainly used for positioning and anchoring during and after the valve implantation process. However, there are some deficiencies in the existing connection methods between the positioning key and the valve. For example:

[0003] It is difficult to completely retrieve the positioning key: For the connection method with the positioning key at the proximal end, after the existing technology positioning key is completely released, it cannot be retrieved into the delivery system again, reducing the success rate of the operation.

[0004] Risk of in vivo assembly operation: When the positioning key is at the proximal end, the length of the TIP end of the delivery system can be effectively shortened, but the difficulty of in vivo overlapping assembly is relatively large, and external force needs to be applied to the positioning key to complete the overlapping assembly of the positioning key and the valve.

[0005] Risk of damaging the cardiac apex when the positioning key is at the distal end: When the positioning key is at the distal end, the overlapping assembly of the positioning key and the valve can be completed in vivo through the pushing system, but it will increase the length of the TIP end of the delivery system. For patients with a smaller ventricular cavity, during the implantation process, due to the longer TIP end of the delivery system, there may be a risk of puncturing the cardiac apex.

[0006] In summary, how to reduce the length of the TIP end of the delivery system to avoid the risk of intraoperative puncturing of the cardiac apex, while achieving the simplicity and safety of in vivo assembly of the positioning key and the complete retrievability of the positioning key is an urgent problem to be solved at present. Summary of the Invention

[0007] In view of this, the present invention provides an implantation and retrieval method of an artificial heart valve and an artificial heart valve positioning key to solve the problem of how to reduce the length of the TIP end of the delivery system to avoid the risk of intraoperative puncturing of the cardiac apex, while achieving the simplicity and safety of in vivo assembly of the positioning key and the complete retrievability of the positioning key.

[0008] In a first aspect, the present invention provides an artificial heart valve, comprising:

[0009] A valve stent,

[0010] A positioning key, the positioning key is sleeved on the outer layer of the valve stent;

[0011] A connection mechanism, the connection mechanism includes a sliding assembly connection line and an auxiliary retrieval connection line;

[0012] One connection end of the sliding assembly connection line is fixed to the valve support, and the other connection end of the sliding assembly connection line is slidingly connected to the positioning key;

[0013] The auxiliary recovery connection line connects the positioning key and the valve stent, and the auxiliary recovery connection line is configured to be pushed by the end of the outer sheath tube to pull the positioning key back into the outer sheath tube of the delivery system;

[0014] Wherein, when the positioning key is released, the positioning key is configured to restore the deformation and slide along the outer layer of the valve stent toward the distal end of the valve stent under the action of the assembly connection line to complete self-assembly; or

[0015] When the positioning key is released, the auxiliary recovery connection line is configured to be pushed by the end of the outer sheath tube to force the positioning key to slide along the outer layer of the valve stent toward the distal end of the valve stent to complete the assembly.

[0016] During the implantation and recovery process of the artificial heart valve, its working mode and effect are specifically reflected as follows: when the positioning key is released from the outer sheath, on the one hand, the positioning key restores the preset elastic deformation due to being free from the constraint of the outer sheath. At this time, the sliding assembly connection line generates tension to guide the positioning key to slide autonomously along the outer layer of the valve stent toward the distal direction until a stable overlapping assembly is formed with the valve stent. This process utilizes the deformation power of the positioning key itself and the guiding effect of the sliding connection line to achieve precise self-assembly without external force intervention.

[0017] On the other hand, if the self-assembly power is insufficient, the outer sheath can continue to be pushed to the distal end, and its end directly pushes against the auxiliary recovery connection line, converting the pushing force into a pulling force on the positioning key, forcing the positioning key to slide along the outer layer of the valve stent to the assembly position, forming a dual drive mechanism to ensure assembly reliability. This method also completes the assembly of the positioning key and the valve under the application of external force, but unlike the prior art, it does not increase the complexity of the delivery system structure, and at the same time, the assembly is achieved in the open state when the positioning key is released.

[0018] In the recovery scenario, when the outer sheath is pushed, its end continuously pushes against the auxiliary recovery connecting line, causing the connecting line to generate traction, guiding the positioning key to shrink and deform, and finally completely withdraw into the outer sheath.

[0019] The above working method realizes the possibility of complete recovery of the positioning key after release through the synergistic effect of elastic deformation power, connection line mechanical transmission and instrument push, and ensures that the self-assembly process has both active drive and passive coercion. It significantly reduces the risk of improper assembly of the positioning key due to jamming or displacement deviation. The fully recoverable performance improves the surgical fault tolerance. At the same time, there is no need to rely on complex release mechanisms or internal constraint structures of the sheath, which simplifies the operation process and improves system reliability.

[0020] In an alternative embodiment, the positioning key is in a broken line shape; the sliding assembly connecting line includes:

[0021] A horizontal line disposed horizontally on the positioning key, with both ends of the horizontal line slidably disposed on two V-shaped connecting portions of the positioning key; the bent portions of the two V-shaped connecting portions face the proximal end;

[0022] A vertical line, one end of which is connected to the valve stent, and the other end of the vertical line is connected to the horizontal line;

[0023] When the positioning key is released, the horizontal line slides on the two V-shaped connecting portions, and forces the positioning key to slide along the outer layer of the valve stent towards the distal end of the valve stent.

[0024] When the positioning key is released from the outer sheath, the positioning key expands during the deployment process. At this time, both ends of the horizontal line of the sliding assembly connecting line slide along the inclined surfaces of the V-shaped connecting portions; at the same time, the vertical line is fixed to the horizontal line and connected to the valve stent. When the positioning key is deployed, due to the horizontal line being pulled by the vertical line and the length of the horizontal line remaining unchanged, as the positioning key is deployed, the included angle between the two V-shaped connecting portions gradually increases. Therefore, in order to adapt to the length of the horizontal line, the two V-shaped connecting portions will slide distally relative to the horizontal line, that is, the positioning key is configured to recover its deformation and slide along the outer layer of the valve stent towards the distal end of the valve stent under the action of the assembly connecting line to complete self-assembly. In this process, without an additional pushing mechanism, precise and reliable self-assembly is completed only by relying on structural deformation and connecting line traction.

[0025] In an alternative embodiment, a plurality of first round holes are evenly distributed in the circumferential direction at the proximal end of the valve stent, a plurality of second round holes are provided at the proximal end of the positioning key, and the auxiliary recovery connecting line is sequentially passed through the first round holes and the second round holes.

[0026] In an alternative embodiment, the first round holes and the second round holes are axially misaligned on the valve stent, or the auxiliary recovery connecting line bypasses the first round holes on the proximal side of the second round holes.

[0027] In an alternative embodiment, the auxiliary recovery connecting line is a multi-strand braided line or a single-strand line, and the material is a high molecular polymer or a metal wire.

[0028] In a second aspect, the present invention also provides an implantation and recovery method for an artificial heart valve positioning key for the above-mentioned artificial heart valve, including the following steps:

[0029] Connect the positioning key and the valve stent through a sliding assembly connecting line and an auxiliary recovery connecting line, and press and hold them on the balloon of the delivery system, and the positioning key is wrapped with an outer sheath;

[0030] After pushing the outer sheath tube to the target position, retract the outer sheath tube to release the positioning key;

[0031] During the release process, under the guidance of the sliding assembly connection line, the positioning key slides distally along the axis of the valve stent to complete the overlapping self-assembly of the positioning key and the valve stent.

[0032] When the positioning key and the valve stent are assembled through the connection mechanism and crimped on the balloon of the delivery system, the outer sheath tube wraps the positioning key to maintain its crimped state; when the outer sheath tube is pushed to the target position and retracted for release, the positioning key recovers its elastic deformation due to the release from the sheath tube constraint. At this time, the sliding assembly connection line, through its fixed connection with the valve stent and sliding fit with the positioning key, converts the deformation expansion force of the positioning key into the driving force for sliding distally along the axis of the valve stent, forcing the positioning key to automatically displace to the preset overlapping position at the moment of release to complete the self-assembly; during this process, the sliding assembly connection line restricts the sliding trajectory of the positioning key through its laterally arranged guiding structure, ensuring that the displacement direction is strictly along the axis of the valve stent to avoid deviation or torsion; at the same time, since the sliding of the positioning key completely depends on its own deformation and the mechanical guidance of the connection line, without the need for an additional pushing mechanism or in-sheath tube constraint, it not only simplifies the structure of the delivery system but also ensures the immediacy and accuracy of the self-assembly action. The effect is that through the self-driving sliding mechanism in the release stage, rapid and stable overlapping assembly of the positioning key and the valve stent is achieved, significantly reducing the risk of positioning deviation caused by insufficient manual intervention; at the same time, the axial sliding path design of the positioning key minimizes the length of the tip of the delivery system, avoiding piercing the apex of the heart due to an overly long tip during the operation and improving the safety of the operation.

[0033] In an alternative embodiment, the step of, during the release process, under the guidance of the sliding assembly connection line, making the positioning key slide distally along the axis of the valve stent to complete the overlapping self-assembly of the positioning key and the valve stent further includes:

[0034] During the release process, push the outer sheath tube of the delivery system so that the outer sheath tube abuts against the auxiliary recovery connection line, and the auxiliary recovery connection line pulls the positioning key to slide distally along the outer layer of the valve stent to finally complete the assembly.

[0035] When the outer sheath tube is actively pushed, its end contacts the auxiliary recovery connection line and applies an axial thrust. At this time, the connection line generates a tensile tension due to the continuous pressing of the sheath tube, converting the linear pushing force of the sheath tube into a directional pulling force of the auxiliary recovery connection line on the proximal end of the positioning key, forcing the positioning key to stably slide distally along the axis with the sliding assembly connection line; during this process, the auxiliary recovery connection line forms a rigid traction path through its fixed points passing through the valve stent and the positioning key, ensuring that the pushing force is accurately transmitted to the positioning key in a linear manner. This method provides a controllable external driving force by actively pushing the outer sheath tube, forming a complementary mechanism with the elastic self-driving force of the positioning key: when the self-assembly power of the positioning key is limited due to tissue resistance or insufficient material deformation, the active pushing of the outer sheath tube can immediately supplement the driving force to ensure the forced completion of the assembly action. The effect is that through the synergistic effect of pushing the outer sheath tube and pulling the connection line, the adaptability of the assembly drive is expanded (compatible with self-elastic drive and external force forced drive), significantly reducing the need for secondary adjustment caused by jamming or displacement deviation of the positioning key, thereby shortening the operation time and improving the implantation success rate.

[0036] In an alternative embodiment, during the release process, through the guidance of the sliding assembly connection line, when the positioning key slides distally along the axis of the valve stent to complete the overlapping self-assembly step of the positioning key and the valve stent, it includes:

[0037] Using the instantaneous elastic force when the positioning key disengages from the outer sheath tube to automatically slide distally towards the valve stent.

[0038] When the outer sheath tube is retracted to release the positioning key, the positioning key instantaneously recovers its preset elastic deformation due to being released from the restraint of the sheath tube, and the radial expansion elastic force generated during the release process is converted into a sliding driving force along the distal end of the axis of the valve stent; at this time, the sliding assembly connection line, through its connection relationship with the fixed end of the valve stent and the sliding end of the positioning key, restricts the acting direction of the elastic force to be strictly along the distal end of the axis, forcing the positioning key to slide directionally along the outer layer of the valve stent immediately upon release until it completely overlaps with the preset position at the distal end to complete self-assembly. During this process, the elastic deformation of the positioning key not only provides the initial sliding power, but its deformation recovery trajectory matches the guiding path of the sliding assembly connection line, enabling the sliding process to be independent of an external pushing mechanism and achieving precise displacement only through the synergistic effect of material elasticity and connection line guidance; at the same time, the rapid release characteristic of the instantaneous elastic force causes the positioning key to start sliding immediately after disengaging from the sheath tube, avoiding displacement deviation or mid-course jamming caused by delay. The effect is that through the coupling mechanism of elastic force drive and connection line guidance, the rapidity and direction controllability of the self-assembly of the positioning key are achieved, significantly reducing the need for manual intervention; and since the elastic force comes from the deformation recovery of the positioning key itself, no additional driving structure is required, simplifying the design of the delivery system.

[0039] In an alternative embodiment, it further includes:

[0040] Retrieve the positioning key: Push the outer sheath tube until it contacts the auxiliary retrieval connecting line, and continue to push the outer sheath tube. Use the guiding effect of the auxiliary retrieval connecting line to pull the positioning key into the outer sheath tube;

[0041] After completely retrieving the positioning key, withdraw the delivery system.

[0042] In an alternative embodiment, the auxiliary retrieval connecting line remains in a relaxed state during self-assembly and becomes taut during the retrieval of the positioning key, for transmitting the pushing force to the positioning key. Description of the Drawings

[0043] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for use in the description of the specific embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0044] Figure 1 Structural schematic diagram of an artificial heart valve according to an embodiment of the present invention (before crimping);

[0045] Figure 2 Structural schematic diagram of an artificial heart valve according to an embodiment of the present invention (after crimping);

[0046] Figure 3 Schematic diagram of the state of the positioning key after an artificial heart valve according to an embodiment of the present invention is released in vivo;

[0047] Figure 4 Schematic diagram of the process of assembling an artificial heart valve according to an embodiment of the present invention by applying an external force in vivo;

[0048] Figure 5 Schematic diagram of the process of retrieving the positioning key of an artificial heart valve according to an embodiment of the present invention.

[0049] Description of the reference numerals:

[0050] 1. Valve stent; 2. Positioning key; 3. Sliding assembly connecting line; 4. Auxiliary retrieval connecting line; 5. First round hole; 6. Second round hole; 7. Outer sheath tube; 8. Balloon. Detailed Embodiments

[0051] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Apparently, the described embodiments are some, but not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0052] For convenience of description, in this embodiment, the end close to the operator is defined as the proximal end, and the end far from the operator is defined as the distal end.

[0053] In the field of transcatheter aortic valve replacement (TAVR) for treating aortic valve regurgitation, the aortic valve positioning key is mainly used for positioning and anchoring during and after valve implantation. However, there are some deficiencies in the connection methods between the existing positioning keys and the valve. For example:

[0054] It is difficult to fully retract the positioning key: For the connection method where the positioning key is located at the proximal end, after the existing technology positioning key is fully released, it cannot be retracted into the delivery system again, reducing the success rate of the operation.

[0055] Risk of in-vivo assembly operation: When the positioning key is located at the proximal end, the length of the TIP end of the delivery system can be effectively shortened, but the difficulty of in-vivo overlapping assembly is relatively large, and an external force needs to be applied to the positioning key to complete the overlapping assembly of the positioning key and the valve.

[0056] Risk of damaging the apex when the positioning key is located at the distal end: When the positioning key is located at the distal end, the in-vivo overlapping assembly of the positioning key and the valve can be completed by pushing the system, but it will increase the length of the TIP end of the delivery system. For patients with a small ventricular cavity, during the implantation process, due to the long TIP end of the delivery system, there may be a risk of puncturing the apex.

[0057] In summary, how to reduce the length of the TIP end of the delivery system to avoid the risk of intraoperative puncturing the apex, while achieving the simplicity and safety of in-vivo assembly of the positioning key and the full retrievability of the positioning key is an urgent problem to be solved at present.

[0058] The following combines Figures 1 to 5 , to describe the embodiments of the present invention.

[0059] According to an embodiment of the present invention, an artificial heart valve is provided, comprising a valve stent 1, a positioning key 2 and a connecting mechanism, wherein the positioning key 2 is sleeved on the outer layer of the valve stent 1; the connecting mechanism comprises a sliding assembly connecting line 3 and an auxiliary recovery connecting line 4, wherein one connecting end of the sliding assembly connecting line 3 is fixed to the valve stent 1, and the other connecting end of the sliding assembly connecting line 3 is slidingly connected to the positioning key 2; the auxiliary recovery connecting line 4 connects the positioning key 2 and the valve stent 1, and the auxiliary recovery connecting line 4 is configured to be pushed by the end of the outer sheath tube 7 to pull the positioning key 2 back into the outer sheath tube 7 of the conveying system; wherein, when the positioning key 2 is released, the positioning key 2 is configured to restore the deformation and slide along the outer layer of the valve stent 1 toward the distal end of the valve stent 1 under the action of the assembly connecting line to complete self-assembly; or when the positioning key 2 is released, the auxiliary recovery connecting line 4 is configured to be pushed by the end of the outer sheath tube 7 to force the positioning key 2 to slide along the outer layer of the valve stent 1 toward the distal end of the valve stent 1 to complete assembly.

[0060] When the positioning key 2 is released from the outer sheath 7, on the one hand, the positioning key 2 restores the preset elastic deformation due to being free from the constraint of the outer sheath 7. At this time, the sliding assembly connecting line 3 generates a pulling force to guide the positioning key 2 to slide autonomously along the outer layer of the valve stent 1 toward the distal direction until a stable overlapping assembly is formed with the valve stent 1. This process utilizes the deformation power of the positioning key 2 itself and the guiding effect of the sliding connecting line to achieve precise self-assembly without external force intervention.

[0061] On the other hand, if the self-assembly power is insufficient, the outer sheath 7 can continue to be pushed to the distal end, and its end directly pushes against the auxiliary recovery connection line 4, converting the pushing force into a pulling force on the positioning key 2, forcing the positioning key 2 to slide along the outer layer of the valve stent 1 to the assembly position, forming a dual drive mechanism to ensure assembly reliability. This method also completes the assembly of the positioning key 2 and the valve under the application of external force, but unlike the prior art, it does not increase the complexity of the delivery system structure, and at the same time, the assembly is achieved in the open state where the positioning key 2 is released.

[0062] In the recovery scenario, when the outer sheath tube 7 is pushed, its end continues to push against the auxiliary recovery connection line 4, so that the auxiliary recovery connection line 4 generates traction, guides the positioning key 2 to shrink and deform, and finally completely withdraws into the outer sheath tube 7.

[0063] The above working method realizes the possibility of complete recovery of the positioning key 2 after release through the synergistic effect of elastic deformation power, connection line mechanical transmission and instrument push, and ensures that the self-assembly process has both active drive and passive coercion. It significantly reduces the risk of improper assembly of the positioning key 2 due to jamming or displacement deviation. The fully recoverable performance improves the surgical fault tolerance. At the same time, there is no need to rely on complex release mechanisms or internal constraints of the sheath, which simplifies the operation process and improves system reliability.

[0064] In one embodiment, Figure 1As shown, the positioning key 2 is in a zigzag shape. The sliding assembly connecting line 3 includes a horizontal line horizontally arranged on the positioning key 2 and a vertical line connecting the horizontal line and the valve stent 1. Both ends of the horizontal line are slidably arranged on two V-shaped connecting parts of the positioning key 2; the bending part of the two V-shaped connecting parts faces the proximal end; one end of the vertical line is connected to the valve stent, and the other end of the vertical line is connected to the horizontal line; when the positioning key 2 is released, the horizontal line slides on the two V-shaped connecting parts and forces the positioning key 2 to slide along the outer layer of the valve stent 1 towards the distal end of the valve stent 1. Preferably, the other end of the vertical line is connected to the middle part of the horizontal line.

[0065] In the above embodiment, as Figure 1 shown in the structure, the upper part is the proximal end and the lower part is the distal end. The zigzag design of the positioning key 2 realizes the directional sliding and assembly functions through the structural characteristics of its two V-shaped connecting parts. Among them, the two connecting parts are rod-shaped parts with two ends connected, and both ends of the horizontal line of the sliding assembly connecting line 3 are slidably arranged on the two rod-shaped parts.

[0066] When the positioning key 2 is released from the outer sheath 7, the positioning key 2 expands during the unfolding process. At this time, both ends of the horizontal line of the sliding assembly connecting line 3 slide along the inclined surface of the V-shaped connecting part; at the same time, the vertical line is fixed to the horizontal line and connected to the valve stent 1, as Figure 2 shown as the structural diagram when the artificial heart valve is crimped. When the crimping is completed, the operator moves the distal part of the positioning key 2 to the horizontal line to form the position as Figure 2 shown. When the positioning key 2 unfolds, as the positioning key 2 unfolds, the included angle between the two V-shaped connecting parts gradually increases. The horizontal line is pulled by the vertical line to keep the position unchanged. At the same time, as the included angle between the two V-shaped connecting parts gradually increases, in order to adapt to the length of the horizontal line, the two V-shaped connecting parts will slide relative to the horizontal line towards the distal end of the valve stent 1, that is, the positioning key 2 is configured to recover the deformation and slide along the outer layer of the valve stent 1 towards the distal end of the valve stent 1 under the action of the assembly connecting line to complete self-assembly. In this process, without an additional pushing mechanism, precise and reliable self-assembly is completed only by relying on structural deformation and connecting line traction.

[0067] In one embodiment, a plurality of first round holes 5 are evenly distributed in the circumferential direction of the proximal end of the valve stent 1, a plurality of second round holes 6 are arranged at the proximal end of the positioning key 2, and the auxiliary recovery connecting line 4 is sequentially passed through the first round holes 5 and the second round holes 6.

[0068] In the above embodiments, the auxiliary recovery connecting line 4 passes through the first round holes 5 at the proximal end of the valve stent 1 and the second round holes 6 at the proximal end of the positioning key 2 to form a multi-point distributed connection structure. When the end of the outer sheath tube 7 pushes against the auxiliary recovery connecting line 4, the pushing force of the outer sheath tube 7 is converted into a uniform pulling force on the positioning key 2; since the first round holes 5 are evenly distributed along the circumferential direction of the proximal end of the valve stent 1 and the connecting line is threaded through each hole, the positioning key 2 is always subjected to multi-directional balanced traction during the recovery process, avoiding offset or tilt caused by unilateral force. At the same time, the second round holes 6 at the proximal end of the positioning key 2 provide fixed anchor points for the auxiliary recovery connecting line 4. When recovering, the auxiliary recovery connecting line 4 is tightened after being pushed against, forcing the proximal end of the positioning key 2 to gather towards the proximal end of the valve stent 1 and slide axially into the outer sheath tube 7. This design precisely converts the linear pushing movement of the outer sheath tube 7 into the axial recovery action of the positioning key 2 through the mechanical transmission mechanism of multi-hole threading, ensuring that the positioning key 2 can still be stably and controllably retracted into the sheath tube after being fully released, while avoiding the fracture of the auxiliary recovery connecting line 4 due to local stress concentration, thereby improving the safety and reliability of the recovery process while simplifying the operation process.

[0069] In one embodiment, the first round holes 5 and the second round holes 6 are axially misaligned on the valve stent 1, or the auxiliary recovery connecting line 4 bypasses the first round holes 5 on the proximal side of the second round holes 6.

[0070] In the above embodiments, the axial misalignment of the first round holes 5 and the second round holes 6 or the design of the auxiliary recovery connecting line 4 bypassing the first round holes 5 on the proximal side of the second round holes 6 optimizes the threading path of the connecting line. When the outer sheath tube 7 pushes against the auxiliary recovery connecting line 4, if the first round holes 5 and the second round holes 6 are axially misaligned, the connecting line forms an oblique traction path after passing through the two holes.

[0071] In one embodiment, the auxiliary recovery connecting line 4 is a multi-strand braided wire or a single-strand wire, and the material is a high molecular polymer or a metal wire.

[0072] In the above embodiments, the multi-strand braided structure of the auxiliary recovery connection line 4 is formed by the twisting of multiple fibers or filaments to achieve high flexibility and fatigue resistance. During the recovery process, it can evenly disperse the concentrated stress generated by the pushing of the outer sheath tube 7, avoiding the risk of fracture caused by local overload. The single-strand wire structure, on the other hand, provides a straight mechanical transmission path without bifurcation through the continuous extension characteristics of a single material, ensuring that the pushing force of the outer sheath tube 7 is accurately converted into the axial traction force on the positioning key 2. When a polymer material is used, its elastic modulus characteristics enable the connection line to withstand tensile loads during recovery and return to a relaxed state after the positioning key 2 slides into the sheath tube. If a metal wire material is selected, its high tensile strength and deformation recovery ability ensure the structural stability of the connection line during repeated pushing and recovery operations. The combination of the above materials and structures enables the connection line to adapt to the mechanical requirements in different surgical scenarios and improves the controllability and durability of the recovery process by optimizing stress distribution and movement guidance.

[0073] According to an embodiment of the present invention, on the other hand, a method for implanting and recovering the positioning key 2 of an artificial heart valve is also provided for the above artificial heart valve, including the following steps:

[0074] Connect the positioning key 2 and the valve stent 1 through the sliding assembly connection line 3 and the auxiliary recovery connection line 4, and press and hold them on the balloon 8 of the delivery system. The positioning key 2 is wrapped with the outer sheath tube 7;

[0075] After pushing the outer sheath tube 7 to the target position, retract the outer sheath tube 7 to release the positioning key 2;

[0076] During the release process, under the guidance of the sliding assembly connection line 3, the positioning key 2 slides axially distally along the valve stent 1 to complete the overlapping self-assembly of the positioning key 2 and the valve stent 1.

[0077] In the implanting and recovering method, its working mode and effect are specifically manifested as follows: When the positioning key 2 and the valve stent 1 are assembled through the connection mechanism and pressed and held on the delivery system balloon 8, the outer sheath tube 7 wraps the positioning key 2 to maintain Figure 2The shown pressing and holding state; when the outer sheath tube 7 is pushed to the target position and retracted for release, the positioning key 2 restores its elastic deformation due to getting out of the sheath tube constraint. At this time, the sliding assembly connecting wire 3, through its fixed connection with the valve stent 1 and sliding fit with the positioning key 2, converts the deformation expansion force of the positioning key 2 into the driving force for sliding axially distally along the valve stent 1, forcing the positioning key 2 to automatically displace to the preset overlapping position instantly at the moment of release, thus completing the self-assembly. During this process, the sliding assembly connecting wire 3 restricts the sliding track of the positioning key 2 through its laterally arranged guiding structure, ensuring that the displacement direction is strictly along the axis of the valve stent 1, avoiding deviation or torsion. At the same time, since the sliding of the positioning key 2 completely depends on its own deformation and the mechanical guidance of the sliding assembly connecting wire 3, without an additional pushing mechanism or in-sheath tube constraint, it not only simplifies the structure of the delivery system but also ensures the immediacy and accuracy of the self-assembly action. The effect is as follows: through the self-driven sliding mechanism in the release stage, the rapid and stable overlapping assembly of the positioning key 2 and the valve stent 1 is realized, significantly reducing the risk of positioning deviation caused by insufficient manual intervention. At the same time, the axial sliding path design of the positioning key 2 minimizes the tip length of the delivery system, avoiding piercing the apex of the heart due to an overly long tip during the operation and improving the surgical safety.

[0078] In one embodiment, during the release process, under the guidance of the sliding assembly connecting wire 3, the positioning key 2 slides distally along the axis of the valve stent 1. The steps for the overlapping self-assembly of the positioning key 2 and the valve stent 1 further include: during the release process, the outer sheath tube 7 of the delivery system is pushed, so that the outer sheath tube 7 presses against the auxiliary recovery connecting wire 4, and the auxiliary recovery connecting wire 4 pulls the positioning key 2 to slide distally along the outer layer of the valve stent 1 until the assembly is finally completed.

[0079] During the assembly process of the above embodiment, its working mode and effect are specifically embodied as: as Figure 4As shown, when the outer sheath tube 7 is actively pushed, its end contacts the auxiliary recovery connection line 4 and applies an axial thrust. At this time, the connection line generates a tensile tension due to the continuous pressing of the sheath tube, converting the linear pushing force of the sheath tube into a directional pulling force of the auxiliary recovery connection line 4 on the proximal end of the positioning key 2, forcing the positioning key 2 to slide stably along the axis of the valve stent 1 towards the distal end with the sliding assembly connection line 3; during this process, the auxiliary recovery connection line 4 forms a rigid traction path through its fixed points passing through the valve stent 1 and the positioning key 2, ensuring that the pushing force is accurately transmitted to the positioning key 2 in a linear manner. This method provides a controllable external driving force by actively pushing the outer sheath tube 7, forming a complementary mechanism with the elastic self-driving force of the positioning key 2: when the self-assembly power of the positioning key 2 is limited due to tissue resistance or insufficient material deformation, the active pushing of the outer sheath tube 7 can immediately supplement the driving force to ensure the forced completion of the assembly action. The effect is that: through the synergistic effect of pushing the outer sheath tube 7 and pulling the connection line, the adaptability of the assembly drive is extended (compatible with self-elastic drive and external force forced drive), significantly reducing the need for secondary adjustment caused by jamming or displacement deviation of the positioning key 2, thereby shortening the operation time and increasing the implantation success rate.

[0080] In one embodiment, during the release process, under the guidance of the sliding assembly connection line 3, the positioning key 2 slides along the axis of the valve stent 1 towards the distal end. In the overlapping self-assembly step of the positioning key 2 and the valve stent 1, it includes: using the instantaneous elastic force when the positioning key 2 disengages from the outer sheath tube 7 to automatically slide towards the distal end of the valve stent 1.

[0081] During the release process of the above embodiment, its working method and effect are specifically manifested as follows: when the outer sheath tube 7 is retracted to release the positioning key 2, the positioning key 2 instantly recovers its preset elastic deformation due to being released from the sheath tube constraint, and the radial expansion elastic force generated during the release process is converted into a sliding driving force along the distal end of the axis of the valve stent 1; at this time, the sliding assembly connection line 3, through its connection relationship with the fixed end of the valve stent 1 and the sliding end of the positioning key 2, restricts the acting direction of the elastic force to be strictly along the distal end of the axis, forcing the positioning key 2 to slide directionally along the outer layer of the valve stent 1 immediately at the moment of release until it completely overlaps with the preset position at the distal end to complete self-assembly. During this process, the elastic deformation of the positioning key 2 not only provides the initial sliding power, but its deformation recovery trajectory matches the guiding path of the sliding assembly connection line 3, enabling the sliding process to be independent of external pushing mechanisms and achieving precise displacement only through the synergistic effect of material elasticity and connection line guidance; at the same time, the fast release characteristic of the instantaneous elastic force enables the positioning key 2 to start sliding immediately after disengaging from the sheath tube, avoiding displacement deviation or mid-course jamming caused by delay. The effect is that: through the coupling mechanism of elastic force drive and connection line guidance, the rapidity and direction controllability of the self-assembly of the positioning key 2 are realized, significantly reducing the need for manual intervention; and since the elastic force comes from the deformation recovery of the positioning key 2 itself, no additional driving structure is required, simplifying the design of the delivery system.

[0082] In one embodiment, the implantation and recovery method of the artificial heart valve positioning key 2 also includes recovering the positioning key 2: pushing the outer sheath 7 until it contacts the auxiliary recovery connection line 4, continuing to push the outer sheath 7, and using the guiding effect of the auxiliary recovery connection line 4 to pull the positioning key 2 into the outer sheath 7; after completely recovering the positioning key 2, withdrawing the delivery system.

[0083] like Figure 5 As shown, when the outer sheath 7 is actively pushed to contact the auxiliary recovery connection line 4, the thrust at the end of the sheath is converted into a pulling force on the positioning key 2 through the connection line, forcing the positioning key 2 to shrink and deform, and finally completely retract into the inner cavity of the sheath; the sheath and the positioning key 2 are wrapped together to further compress its deformation, ensuring that there is no structural exposure after recovery. This method realizes mechanical transmission, deformation contraction and structural storage synchronously through a single sheath pushing action, without relying on additional release equipment or complicated operation steps, simplifying the recovery process, and realizing fast and thorough recovery of the positioning key 2 and system withdrawal.

[0084] In one embodiment, the auxiliary recovery connection line 4 remains in a relaxed state during the self-assembly process, and is turned into a tensioned state during the recovery process of the positioning key 2 , so as to transmit a pushing force to the positioning key 2 .

[0085] In the above embodiment, the working state of the auxiliary recovery connection line 4 is dynamically switched according to the operation stage: during the self-assembly process, the auxiliary recovery connection line 4 remains loose, so that it does not generate additional resistance or pulling force on the sliding of the positioning key 2, and the positioning key 2 only relies on its own deformation power and the guidance of the sliding assembly connection line 3 to complete the axial displacement, thereby ensuring the freedom and smoothness of the self-assembly process; when the self-assembly is not in place, the pushing force of the outer sheath tube 7 acts on the auxiliary recovery connection line 4, so that it changes from a loose state to a tensioned state, and transmits the linear pushing force of the outer sheath tube 7 to the positioning key 2 in a nearly lossless manner, forcing the positioning key 2 to slide to the distal end and overlap with the valve stent 1 for assembly; when recovery is required, the pushing force of the outer sheath tube 7 acts on the auxiliary recovery connection line 4, so that it changes from a loose state to a tensioned state, forcing the positioning key 2 to retract into the outer sheath tube 7.

[0086] Although the embodiments of the present invention have been described in conjunction with the accompanying drawings, those skilled in the art may make various modifications and variations without departing from the spirit and scope of the present invention, and such modifications and variations are all within the scope defined by the appended claims.

Claims

1. An artificial heart valve, characterized in that, Comprising: A valve stent (1), A positioning key (2), the positioning key (2) being sleeved on the outer layer of the valve stent (1); A connecting mechanism, the connecting mechanism comprising a sliding assembly connecting wire (3) and an auxiliary recovery connecting wire (4); One connecting end of the sliding assembly connecting wire (3) is fixed to the valve stent (1), and the other connecting end of the sliding assembly connecting wire (3) is slidably connected to the positioning key (2); The auxiliary recovery connecting wire (4) connects the positioning key (2) and the valve stent (1), and the auxiliary recovery connecting wire (4) is configured to be pushed by the end of the outer sheath (7) to pull the positioning key (2) back into the outer sheath (7) of the delivery system; Wherein, when the positioning key (2) is released, the positioning key (2) is configured to recover its deformation and slide distally along the outer layer of the valve stent (1) under the action of the assembly connecting wire to complete self-assembly; Or When the positioning key (2) is released, the auxiliary recovery connecting wire (4) is configured to be pushed by the end of the outer sheath (7) to force the positioning key (2) to slide distally along the outer layer of the valve stent (1) to complete assembly.

2. The artificial heart valve according to claim 1, characterized in that, The positioning key (2) is in a zigzag shape; the sliding assembly connecting wire (3) comprises: A horizontal line disposed horizontally on the positioning key (2), both ends of the horizontal line being slidably disposed on two V-shaped connecting portions of the positioning key (2); the bends of the two V-shaped connecting portions face the proximal end; A vertical line, one end of which is connected to the valve stent (1), and the other end of the vertical line is connected to the horizontal line; When the positioning key (2) is released, the horizontal line slides on the two V-shaped connecting portions, and forces the positioning key (2) to slide distally along the outer layer of the valve stent (1).

3. The artificial heart valve according to claim 1 or 2, characterized in that, A plurality of first round holes (5) are evenly distributed in the circumferential direction at the proximal end of the valve stent (1), a plurality of second round holes (6) are provided at the proximal end of the positioning key (2), and the auxiliary recovery connecting wire (4) is sequentially passed through the first round holes (5) and the second round holes (6).

4. The artificial heart valve according to claim 3, characterized in that, The first round holes (5) and the second round holes (6) are axially offset on the valve stent (1), or the auxiliary recovery connecting wire (4) bypasses the first round holes (5) on the proximal side of the second round holes (6).

5. The artificial heart valve according to any one of claims 1-4, characterized in that, The auxiliary recovery connecting wire (4) is a multi-strand braided wire or a single-strand wire, and the material is a polymer or a metal wire.

6. A method for implanting and retrieving a positioning key of an artificial heart valve, which is used for the artificial heart valve according to any one of claims 1-5, characterized in that, Including the following steps: Connect the positioning key (2) and the valve stent (1) through the sliding assembly connecting wire (3) and the auxiliary recovery connecting wire (4), and press and hold them on the balloon (8) of the delivery system, and the positioning key (2) is wrapped with the outer sheath (7); After pushing the outer sheath (7) to the target position, withdraw the outer sheath (7) to release the positioning key (2); During the release process, under the guidance of the sliding assembly connecting wire (3), the positioning key (2) slides distally along the axis of the valve stent (1) to complete the overlapping self-assembly of the positioning key (2) and the valve stent (1).

7. The implantation and retrieval method of the positioning key of the artificial heart valve according to claim 6, characterized in that, During the release process, guided by the sliding assembly connecting wire (3), the positioning key (2) slides distally along the axis of the valve stent (1). The step of completing the overlapping self-assembly of the positioning key (2) and the valve stent (1) further includes: During the release process, push the outer sheath (7) of the delivery system so that the outer sheath (7) abuts against the auxiliary recovery connecting wire (4), and the auxiliary recovery connecting wire (4) pulls the positioning key (2) to slide distally along the outer layer of the valve stent (1) to finally complete the assembly.

8. The implantation and retrieval method of the positioning key of the artificial heart valve according to claim 6, characterized in that, During the release process, guided by the sliding assembly connecting wire (3), when the positioning key (2) slides distally along the axis of the valve stent (1) to complete the overlapping self-assembly step of the positioning key (2) and the valve stent (1), it includes: Utilize the instantaneous elastic force when the positioning key (2) disengages from the outer sheath (7) to automatically slide distally towards the valve stent (1).

9. The implantation and retrieval method of the positioning key of the artificial heart valve according to claim 6, characterized in that, It further includes: Recover the positioning key (2): Push the outer sheath (7) until it contacts the auxiliary recovery connecting wire (4), and continue to push the outer sheath (7). Utilize the guiding action of the auxiliary recovery connecting wire (4) to pull the positioning key (2) into the outer sheath (7). After completely recovering the positioning key (2), withdraw the delivery system.

10. The method for implanting and retrieving the positioning key of the artificial heart valve according to claim 9, characterized in that, The auxiliary recovery connecting wire (4) remains in a relaxed state during the self-assembly process and turns into a tensioned state during the recovery process of the positioning key (2) to transmit the pushing force to the positioning key (2).

Images