Implant conveying device and system application method

Abstract

The invention relates to the technical field of medical instruments, in particular to an application method adopting an implant conveying device.The method comprises the steps that an implant (3) is conveyed to a targeted part through the conveying device, the implant (3) is released at the targeted part, and the implant conveying device comprises a handle (2) and a tube body (1); an implant (3) is arranged in the tube body (1), the tube body (1) is arranged at the far end of the handle, the handle (2) drives the tube body (1), the tube body (1) containing the implant (3) is pushed to a targeted part by operating the handle (2), and the tube body (1) releases the implant (3). According to the method, the implant can be anchored on the valve ring, the problem of valve leaflet pairing is solved by reducing the size of the tricuspid valve ring, the valve cannot be narrowed or locked, the valve leaflet prolapse cannot be caused, and the autologous tricuspid valve leaflet cannot be damaged.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and specifically to an application method using an implant delivery device and system. Background Technology

[0002] The tricuspid valve is a one-way valve that allows blood to flow from the atria to the ventricles and then to the lungs. If a patient has tricuspid regurgitation, where blood is forced from the heart towards the lungs, blood leaks back into the right atrium due to the valve defect, causing fluid buildup and weakness.

[0003] Extensive literature on surgical procedures shows that valve repair yields better results than valve replacement. Furthermore, catheter-based interventional therapy avoids the significant risks and intolerances associated with open-heart surgery in older patients. This patent provides an implant delivery device for tricuspid valve repair via interventional procedures.

[0004] Current transcatheter tricuspid valve repair methods mainly involve using valve clips to repair the leaflets edge-to-edge. However, the implanted valve clips are relatively large, which may cause stenosis and atresia, and the large weight of the valve clips may cause leaflet prolapse.

[0005] ZL201310456429.7 discloses a folding lock delivery system capable of percutaneously delivering suture lock components.

[0006] ZL201420291000.7 discloses a suture cutter. The suture cutter may include an actuator, an intermediate sleeve, and a movable cutting assembly. The cutting assembly, operatively coupled to the actuator, includes a cutting element. Summary of the Invention

[0007] In view of the above-mentioned technical status, this invention provides a new method for applying interventional devices. The implant is anchored to the valve annulus, and then the regurgitation orifice area of ​​the valve is reduced by annular contraction to repair the valve. Compared with valve clips, the implant is anchored to the valve annulus rather than the valve leaflets, thus avoiding valve stenosis or occlusion, as well as leaflet prolapse.

[0008] The present invention provides an application method of an implant delivery device, the method comprising using the delivery device to deliver an implant to a target site and releasing the implant at the target site, the delivery device comprising a handle and a tube, the tube comprising the implant, the tube being disposed at the distal end of the handle, the handle driving the tube, and by operating the handle pushing the tube containing the implant to the target site, the tube releasing the implant.

[0009] In the method of the present invention, as one of the implementation schemes, the tube body mainly consists of three layers, including a screw-in tube, a puncture tube, and a push tube, wherein the screw-in tube is located in the outermost layer of the tube body, the puncture tube is located in the middle layer of the tube body, and the push tube is located in the inner layer of the tube body. The tube body includes the push tube, and the puncture tube contains the implant inside the tube body.

[0010] In the method of the present invention, as one of the implementation schemes, the screw-in tube is composed of a metal tube covered with a heat-shrinkable protective tube. Preferably, the metal tube includes a seamless steel tube at the near end, a laser-cut section on the seamless steel tube in the middle section, a tightly wound spring tube at the far end, and a spring tube with an increased pitch at the tip. Preferably, the tip of the screw-in tube is ground into a triangular face to form a sharp corner.

[0011] In one embodiment of the present invention, the puncture tube is composed of a metal tube covered with a heat-shrinkable protective tube. The proximal end of the metal tube is a seamless steel tube, the middle section is a tightly wound spring tube, and the tip is a syringe needle tip structure.

[0012] In one embodiment of the present invention, the pushing tube is composed of a metal tube covered with a heat-shrinkable protective tube, with the near end of the metal tube being a seamless steel tube and the far end being a tightly wound spring tube.

[0013] In one embodiment of the method of the present invention, the implant is located inside the puncture tube and at the front end of the push tube.

[0014] In one embodiment of the method of the present invention, the implant includes an anchoring component and a pull wire. Preferably, the anchoring component is a perforated metal sheet structure, a textile structure, or a textile-wrapped metal sheet structure. The pull wire passes through the inner cavity of the push tube and the center hole of the proximal end cap of the push tube sealing seat and is connected to the pull wire module where the pull wire knob on the handle is located.

[0015] In this invention, as one embodiment, the outermost layer of the tube body is a screw-in tube, composed of a metal tube covered with a heat-shrinkable protective tube. The proximal end of the metal tube is a seamless steel tube to ensure its rigidity. The middle section consists of a laser-cut notch added to the seamless steel tube, giving it both rigidity and flexibility, allowing for a certain degree of bending. The distal end is a tightly wound spring tube, which is more flexible and easier to bend and twist than a laser-cut hypotube. The tip is a spring tube with an increased pitch, and the very tip is ground into a triangular facet to form a sharp angle. The middle layer of the tube body is a puncture tube, composed of a metal tube covered with a heat-shrinkable protective tube. The proximal end of the metal tube is a seamless steel tube, the middle section is a tightly wound spring tube, and the tip has a syringe needle tip structure. The inner layer of the tube body is a push tube, composed of a metal tube covered with a heat-shrinkable protective tube. The proximal end of the metal tube is a seamless steel tube, and the distal end is a tightly wound spring tube.

[0016] In this invention, the implant comprises an anchoring portion and a suture. The anchoring portion is a perforated metal sheet structure, a textile structure, or a textile-wrapped metal sheet structure. The suture passes through the inner cavity of the push tube and the central hole of the proximal end cap of the push tube sealing seat, and is connected to the suture module where the suture knob is located. The textile is polyester, PET, or polyethylene terephthalate. The metal in the metal sheet structure is made of a biocompatible material, such as stainless steel, nickel-titanium, or cobalt-chromium alloy. The holes on the metal sheet are threading holes, through which the suture connects to the anchoring portion, or the suture is directly sewn onto the textile and connected to the anchoring portion. The anchoring portion is straight or foldable. The suture is an ePTFE or polyester surgical suture. The straight portion can be, but is not limited to, a non-foldable sheet shape.

[0017] In one embodiment of the method of the present invention, the handle portion includes a screw-in tube knob, a locking pin, a puncture tube knob, a linkage button, a push tube button, a control rod, a pull wire knob, a handle upper cover, and a handle lower cover. The handle portion can drive the tube body, enabling the anchoring of the implant.

[0018] In one embodiment of the method of the present invention, the screw-in tube knob is located at the distal end of the handle portion and can drive the screw-in tube forward or backward; the screw-in tube knob, puncture tube knob, and push tube button control the forward or backward movement of the tube body portion; the locking pin controls the activation and deactivation of the screw-in tube knob and the push tube button; the puncture tube knob and the push tube knob can only rotate after the locking pin is removed. The puncture tube knob and the push tube button can rotate in unison or independently under the control of the linkage button; the control lever is a brake that controls the rotation of the pull-wire knob.

[0019] In one embodiment of the present invention, the distal end of the screw-in tube knob is provided with a countersunk hole and a guide opening, the middle is a small through hole, and the proximal end is a cavity with an internally threaded helix. The screw-in tube is inserted into the countersunk hole at the distal end and extends into the cavity. Glue is injected through the countersunk hole and the guide opening to fix the screw-in tube and the screw-in tube knob together. The distal outer walls of the upper and lower handle covers are respectively provided with externally threaded helical lines that match the helix of the screw-in tube knob cavity. When the handle is fixed, the screw-in tube knob drives the screw-in tube to move forward and backward along the helix of the thread.

[0020] In the method of this invention, as a preferred embodiment, the proximal end of the screw-in tube and the internal puncture and push tube enter the screw-in tube sealing seat. The screw-in tube sealing seat consists of a distal cap, a main body, and a proximal cap. The distal cap, proximal cap, and main body can be connected by screws or adhesive. The proximal boss of the distal cap and the countersunk hole at the distal end of the main body form a cavity for placing a distal O-ring for sealing. The main body has side holes for connecting a tubing to inject physiological saline or heparinized physiological saline into the sealing seat to flush the inner cavity of the screw-in tube. The distal boss of the proximal cap and the stepped hole at the proximal end of the main body form a cavity for placing a silicone hemostatic valve for sealing.

[0021] In one embodiment of the method of the present invention, the screw-in tube, the puncture tube, and the push tube are not fixedly connected to the screw-in tube sealing seat, which can ensure that the screw-in tube, the puncture tube, and the push tube can move back and forth when the screw-in tube sealing seat remains stationary.

[0022] In the method of the present invention, as one of the embodiments, the handle part further includes a puncture tube drive frame, a puncture tube retaining ring, a push tube retaining ring, and a push tube drive frame; wherein, the puncture tube passes through the screw-in tube sealing seat, the proximal end extends to the puncture tube retaining ring and is fixed, the puncture tube retaining ring is placed in the groove of the puncture tube drive frame, the side of the puncture tube drive frame has a rack, and the bottom of the puncture tube knob (23) has the tooth shape of a gear, and the two mesh with each other to perform transmission.

[0023] In one embodiment of the present invention, the push tube passes through the screw-in tube sealing seat and the puncture tube retainer and is fixed to the push tube retainer, with the proximal end inserted into the inner cavity of the push tube sealing seat. The push tube retainer is placed in the groove of the push tube drive frame. The side of the push tube drive frame has a rack, and the bottom of the push tube knob has the tooth shape of a gear. The two mesh with each other to perform transmission. The push tube knob transmits the push tube drive frame through the gear.

[0024] In the method of the present invention, as one of the implementation schemes, the proximal end of the push tube (13) enters the push tube sealing seat; the push tube sealing seat is composed of a distal end cap, a main body and a proximal end cap; the distal end cap, the proximal end cap and the main body can be connected by screws or glued; the proximal countersunk hole of the distal end cap and the distal boss of the main body form a cavity for placing a distal O-ring for sealing; there is a side hole near the proximal end of the main body for connecting a tubing to inject physiological saline or heparinized physiological saline into the sealing seat to flush the inner cavity of the push tube; the distal boss of the proximal end cap and the stepped hole at the proximal end of the main body form a cavity for placing a silicone hemostatic valve for sealing.

[0025] In one embodiment of the present invention, the suture of the implant passes through the inner cavity of the push tube and extends out from the central hole of the proximal cap of the push tube sealing seat to the suture module where the suture knob is located. In another embodiment, when the linkage button is in its initial position (raised), the puncture tube and the push tube can be linked for control; that is, rotating the puncture tube knob or the push tube knob can move the puncture tube and the push tube forward or backward together. When the linkage button is pressed, the linkage is released.

[0026] In one embodiment of the present invention, the linkage button has a large spring at its bottom and two sets of small springs at its top. The linkage button has a gear structure inside. Preferably, the upper part of the linkage button has a horizontal through hole, and a cylindrical beam is placed in the through hole. Deep blind holes are opened at both ends of the beam, and a small spring is placed in the blind hole. One end of the small spring contacts the bottom of the blind hole, and a metal ball is placed at the other end. The metal ball is pushed by the small spring and will press against the recess in the handle cover. When the linkage button is in the initial position, the metal ball presses against the upper recess in the handle cover, and at this time the large spring at the lower end of the linkage button is in its original length and is not compressed.

[0027] In the method of the present invention, as one of the implementation schemes, when the linkage button is pressed, the small spring pushes the metal ball downwards until the metal ball is stuck in the lower recess of the handle cover; the large spring at the lower end of the linkage button is in a compressed state, and the teeth below the linkage button disengage from the teeth below the puncture tube knob and the push tube knob, so that the puncture tube and the push tube can be controlled independently.

[0028] In one embodiment of the present invention, the handle portion includes a pull-wire module with a pull-wire knob located at its proximal end. This pull-wire module comprises a pull wire, a spool, a spool gear, a spool lock, a tension spring, and a control rod. The pull wire of the implant extends from the central hole of the proximal end cap of the push tube sealing seat and is wound around the spool. A non-standard involute toothed spool gear is placed below the spool. The teeth are asymmetrical, ensuring that the gear drives the spool to rotate only in one direction when meshing with the teeth on the spool lock. This gear is used to fold the foldable anchoring portion of the implant. The implant is folded by tightening the pull wire. The portion of the implant to be folded is pushed out of the puncture tube and folded at the beveled tip of the puncture tube. The spool knob is placed above the spool but is not fixedly connected; it is secured to the handle cover by the spool knob end cap to prevent it from being moved arbitrarily.

[0029] In one embodiment of the method of the present invention, the spool lock is tightened on the handle cover by a tension spring to ensure that the teeth on the spool lock mesh with the teeth of the spool gear; when the implant has been implanted at the target position, the upward undulating control rod is fixed to the corresponding protrusion on the handle cover; at this time, the spool lock disengages from the spool gear, the entire instrument is retracted, and the spool will rotate rapidly to separate the pull wire on the spool from the spool.

[0030] In one embodiment of the present invention, the screw-in tube knob has a countersunk hole and a guide opening at its distal end, a small through hole in the middle, and a cavity with an internally threaded helix at its proximal end. The screw-in tube is inserted into the countersunk hole at the distal end and passes through the hole, extending into the cavity. Glue can be injected through the countersunk hole and the guide opening of the countersunk hole to fix the screw-in tube and the screw-in tube knob together.

[0031] In the method of the present invention, as one of the implementation schemes, glue is injected only at the countersunk hole at the far end of the screw-in tube knob to fix the tube body to the handle part, while other parts of the handle are not fixedly connected to the tube body and can move back and forth.

[0032] In the method of the present invention, the handle part is provided with an upper cover and a lower cover. The upper cover and the lower cover are fastened together to fix the internal structure and the tube part of the handle part inside. The outer walls of the far ends of the upper cover and the lower cover are respectively provided with external threaded spiral lines that match the spiral line of the screw-in tube knob cavity. That is, the screw-in tube knob firmly fastens and fixes the upper cover and the lower cover together through the threaded lines.

[0033] In the method of the present invention, the handle portion is provided with a screw-in tube sealing seat and a push tube sealing seat. Both the screw-in tube sealing seat and the push tube sealing seat are composed of three parts: a distal end cap, a proximal end cap, and a main body. The distal end cap and the main body form a cavity, and a sealing ring is provided in the cavity. The proximal end cap and the other side of the main body form a cavity, and a hemostatic valve is provided in the cavity. The main body is provided with a side hole, through which liquid can be injected into the sealing seat to flush the inner cavity of the screw-in tube. The liquid is preferably injectable physiological saline or heparinized physiological saline. The distal end cap, the proximal end cap, and the main body are fixedly connected, preferably by screw connection or adhesive connection.

[0034] In the method of the present invention, as one of the preferred embodiments, in the screw-in tube sealing seat: the proximal boss of the distal end cap and the countersunk hole at the distal end of the main body form a cavity, and a distal O-ring is placed in the cavity. The material of the sealing ring includes, but is not limited to, silicone, rubber, and elastomer materials. The distal boss of the proximal end cap and the stepped hole at the proximal end of the main body form a cavity, and a silicone hemostatic valve is placed in the cavity. The main body is provided with side holes and countersunk holes, through which liquid can be injected into the sealing seat to flush the inner cavity of the screw-in tube. The proximal end of the screw-in tube and the puncture tube and push tube inside it penetrate into the screw-in tube sealing seat but are not fixedly connected to the screw-in tube sealing seat, which can ensure that when the sealing seat remains stationary, the screw-in tube, puncture tube, and push tube can move back and forth.

[0035] In one embodiment of the present invention, in the push tube sealing seat: the proximal countersunk hole of the distal end cap and the distal end boss of the main body form a cavity, and a distal O-ring seal is placed in the cavity. There is a side hole near the proximal end of the main body for connecting a tubing to inject physiological saline or heparinized physiological saline into the sealing seat to flush the inner cavity of the push tube. The distal end boss of the proximal end cap and the stepped hole at the proximal end of the main body form a cavity, and a silicone hemostatic valve is placed in the cavity.

[0036] In the method of the present invention, the handle portion further includes a puncture tube drive frame, a puncture tube retaining ring, a push tube retaining ring, and a push tube drive frame. The puncture tube passes through the screw-in tube sealing seat, extends proximally to the puncture tube retaining ring, and is fixed thereto. The puncture tube retaining ring is placed in the groove of the puncture tube drive frame. The side of the puncture tube drive frame has a rack, and the bottom of the puncture tube knob has a gear tooth shape. The puncture tube knob can drive the puncture tube drive frame through the gear.

[0037] In the method of the present invention, the push tube passes through the screw-in tube sealing seat and the puncture tube retaining ring and is fixed with the push tube retaining ring, and the proximal end is inserted into the inner cavity of the push tube sealing seat. The push tube retaining ring is placed in the groove of the push tube drive frame. The side of the push tube drive frame has a rack, and the bottom of the push tube knob has the tooth shape of a gear. The push tube knob drives the push tube drive frame through the gear.

[0038] In one embodiment of the present invention, the linkage button is provided with a large spring at the bottom and two sets of small springs at the top. The linkage button has a gear structure inside. Preferably, the linkage button is provided with a horizontal through hole at the top, and a cylindrical beam is provided in the through hole. Blind holes are opened at both ends of the beam. A set of small springs is placed in each blind hole. One end of the small spring contacts the bottom of the blind hole, and a metal ball is placed at the other end. The large spring is provided at the bottom.

[0039] In one embodiment of the present invention, the handle portion is further provided with a pull-wire module containing a pull-wire knob at its proximal end. The pull-wire module includes a pull wire, a spool, a spool gear, a spool lock, a tension spring, and a control lever. The pull wire is wound around the spool. A non-standard involute toothed spool gear is placed below the spool. The teeth are asymmetrical. When meshing with the teeth on the spool lock, it ensures that the gear drives the spool to rotate only in one direction. The spool knob is located above the spool but is not fixedly connected. It is secured to the handle cover by the spool knob end cap to ensure that it cannot be moved arbitrarily.

[0040] In one embodiment of the present invention, the spool lock is tightened to the handle cover by a tension spring to ensure that the teeth on the spool lock mesh with the teeth of the spool gear.

[0041] In one embodiment of the present invention, the implant delivery device is used in conjunction with an adjustable large sheath, an adjustable small sheath, an implant locking device, and a wire cutting device.

[0042] As one embodiment of the method of the present invention, the present invention also provides an application method of an implant delivery system, the method comprising using the implant delivery system to deliver an implant to a target site and releasing the implant at the target site, the implant delivery system comprising the delivery device described in the present invention and an adjustable curved sheath.

[0043] In the method of the present invention, as one of the implementation schemes, the adjustable bending sheath includes, but is not limited to, an adjustable bending small sheath and an adjustable bending large sheath.

[0044] In one embodiment of the method of the present invention, the implant delivery system includes the delivery device, the adjustable bending sheath, and the device for locking the implant as described in the present invention.

[0045] In one embodiment of the method of the present invention, the implant delivery system includes the delivery device, adjustable bending sheath, and wire cutting and pulling instrument described in the present invention.

[0046] Compared with the prior art, the application method of the implant delivery device and system described in this invention has the following advantages:

[0047] 1. Compared with valve clips, implants are smaller in size and weight. They can reliably tighten the valve annulus by folding and tightening, while avoiding the risk of valve clips falling off.

[0048] 2. Compared with valve clips, the implant contains less metal, effectively reducing the damage to the body caused by excessive metal ion release.

[0049] 3. Polyester and surgical sutures have good biocompatibility and can be quickly and completely endothelialized with autologous tissue when implanted at the valve annulus.

[0050] 4. Valve size varies from person to person, but the length of the valve clip arm is fixed, which may lead to improper clipping during surgery. However, the implant can be precisely positioned by intraoperative ultrasound to identify the target location, combined with the screw-in cannula screwing into the valve annulus, and there is sufficient room for adjustment to avoid adverse events.

[0051] 5. All catheters used in the implant delivery and deployment process are operated on the atrial side and do not enter the ventricle, so they will not affect the ventricle or the chordae tendineae inside the ventricle.

[0052] 6. Over 90% of tricuspid regurgitation is functional (secondary), mostly caused by annular dilation leading to poor leaflet occlusion. This method uses a catheter-based approach to perform tricuspid annular reduction, improving leaflet occlusion by shrinking the tricuspid annulus, without causing any damage to the patient's own tricuspid valve leaflets. Attached Figure Description

[0053] Figure 1 : Overall view of the implant delivery device including the handle and the tube body;

[0054] Figure 2 Schematic diagram of the side cross section of the pipe body;

[0055] Figure 3 : Schematic diagram of the implant and suture structure (anchoring part is straight);

[0056] Figure 4 : Schematic diagram of the implant and suture structure (the anchoring part is foldable);

[0057] Figure 5 : Schematic diagram of the handle's structure;

[0058] Figure 6 : Schematic diagram of the connection between the handle and the screw-in tube;

[0059] Figure 7 : Schematic diagram of the connection structure between the handle and the puncture tube and the push tube;

[0060] Figure 8 : Schematic diagram of the connection structure between the push tube and the handle;

[0061] Figure 9 : Schematic diagram of the linkage control of the linkage button, puncture tube knob and push tube knob;

[0062] Figure 10 : Schematic diagram of individual control of the linkage button, puncture tube knob and push tube knob;

[0063] Figure 11 Perspective view of the internal structure of the wire-drawing module;

[0064] Figure 12 : A schematic diagram of the pull-cord module structure, including the pull-cord knob;

[0065] Figure 13 : Schematic diagram of the adjustable curved sheath and target position;

[0066] Figure 14 : Schematic diagram of the connection between the adjustable large sheath, the adjustable small sheath, and the implant delivery device;

[0067] Figure 15 : Schematic diagram showing how the spiral needle is inserted into the valve annulus tissue from the atrial side by rotating the cannula at the target location;

[0068] Figure 16 : A schematic diagram showing the puncture cannula entering the ventricle through the valve annulus tissue on the atrial side via the inner lumen of the screw-in cannula and spiral needle;

[0069] Figure 17 The push tube pushes the implant along the puncture tube into the ventricle, completing the ventricular side implant deployment diagram;

[0070] Figure 18 : Schematic diagram of implant puncture and deployment completed, with the cannula retracted and screwed in;

[0071] Figure 19 : A schematic diagram of a tricuspid valve with two implants deployed;

[0072] Figure 20 : Schematic diagram of the connection between the adjustable curved sheath and the locking implant;

[0073] Figure 21 : A schematic diagram of a device implanted into a lock body using a lock body implant;

[0074] Figure 22 : Schematic diagram of the connection between the adjustable curved sheath and the cutting guide wire;

[0075] Figure 23 : Schematic diagram of the valve ring retraction after the lock body release cable has been cut;

[0076] Figure 24 Schematic diagram of the screw-in tube structure;

[0077] Figure 25 : Schematic diagram of the puncture tube structure;

[0078] Figure 26 Schematic diagram of the push tube structure.

[0079] Figure reference numerals: 0. Implant delivery device; 1. Tube body; 2. Handle; 3. Implant; 11. Screw-in cannula; 12. Puncture cannula; 13. Push cannula; 31. Anchoring part; 32. Pull cable; 21. Screw-in cannula knob; 22. Locking pin; 23. Puncture cannula knob; 24. Linkage button; 25. Push cannula knob; 26. Control lever; 27. Pull cable knob; 28. Handle upper cover; 29. ​​Handle lower cover; 41. Screw-in cannula sealing seat; 42. Puncture cannula drive frame. ; 43 Puncture tube clamping ring; 44 Push tube clamping ring; 45 Push tube drive frame; 46 Push tube sealing seat; 51 Crossbeam; 52 Large spring; 53 Small spring; 54 Metal ball; 281 Spool knob end cap; Pulling wire module 6; 61 Spool lock; 62 Spool; 63 Spool gear; 64 Tension spring; 71 Adjustable large sheath; 72 Adjustable small sheath; 8 Spiral needle; 10 Locking body; 91 Instrument for locking implants; 92 Instrument for cutting and pulling wires;

[0080] 101 Center hole; 102 Countersunk hole; 103 Guide port; 104 Through hole; 105 Cavity; 106 Helix; 107 Distal cap; 108 Body; 109 Proximal cap of screw-in tube sealing seat; 110 Proximal boss; 111 Countersunk hole; 112 Measuring hole; 113 Distal boss; Groove 115; Rack 116; Groove 117; 118 Distal cap; 119 Body; 120 Proximal cap of push tube sealing seat; 121 Proximal countersunk hole; 122 Distal boss; 123 O-ring; 124 Side hole; 125 Distal boss; 126 Stepped hole; 127 Transverse through hole; 128 Blind hole; 129 Recess; 130 Recess; 131 Raised point.

[0081] 1111: Triangular facet at the tip of a screw-in tube; 1112: Bourdon tube with increased pitch; 1113: Seamless steel tube with laser-cut notch; 1114: Close-wound Bourdon tube; 1115: Heat-shrinkable protective tube; 1116: Seamless steel tube;

[0082] 1221: Syringe needle tip structure; 1222: Closely wound spring tube; 1223: Heat shrinkable protective tube; 1224: Seamless steel tube;

[0083] 1331: Close-wound spring tube; 1332: Heat-shrinkable protective tube; 1333: Seamless steel pipe. Detailed Implementation

[0084] The following embodiments, in conjunction with the accompanying drawings, are used to further illustrate the present invention, but do not limit the scope of the invention in any way.

[0085] In specific embodiments, the "distal end" of the present invention refers to the end away from the operator when the operator holds the handle during the operation, and the "proximal end" refers to the end close to the operator when the operator holds the handle during the operation. The terms "upper," "lower," "left," "right," "front," "back," "top," "bottom," "inner," "outer," "middle," etc., used in the present invention to indicate orientation or positional relationships are based on the orientation or positional relationships shown in the accompanying drawings. These terms are mainly used to better describe the present invention and its embodiments, and are not intended to limit the indicated device, nor do they constitute a limitation on the present invention.

[0086] Furthermore, the terms "set", "equipped", "connected", and "connected" used in this invention should be interpreted broadly. They can refer to fixed connections or non-fixed connections, mechanical connections or any other type of connection, direct connections or indirect connections through a medium. Connection methods commonly used by those skilled in the art are all within the scope of protection of this invention.

[0087] The materials used in the device in this embodiment are merely illustrative and do not imply that the device can only be made of that material.

[0088] like Figure 1 As shown, in the method of the present invention, as one of the implementation schemes, the implant delivery device of the present invention mainly consists of a handle part 2 and a tube part 1. The tube 1 includes an implant 3. The tube 1 is located at the distal end of the handle. The handle 2 drives the tube 1. By operating the handle 2, the tube 1 is pushed to the target site, and the implant 3 inside the tube 1 is released at the target position.

[0089] like Figure 2 , Figures 24-26 As shown, in the method of the present invention, as one of the implementation schemes, the tube body is mainly composed of three layers: screw-in tube 11, puncture tube 12 and push tube 13, wherein the screw-in tube 11 is located in the outermost layer of the tube body 1, the puncture tube 12 is located in the middle layer of the tube body 2, and the push tube 13 is located in the inner layer of the tube body 1.

[0090] In one embodiment of the present invention, the outermost layer is a screw-in tube 11, which consists of a metal tube covering a heat-shrinkable protective tube 1115. Preferably, the metal tube includes a seamless steel tube 1116 at the near end, a laser-cut section 1113 on the seamless steel tube in the middle section, a tightly wound spring tube 1114 at the far end, and a spring tube 1112 with an increased pitch at the tip. Preferably, the tip of the screw-in tube is triangular, forming a sharp angle 1111.

[0091] The middle layer is the puncture tube 12, which consists of a metal tube covered with a heat-shrinkable protective tube 1223. The proximal end of the metal tube is a seamless steel tube 1224, the middle section is a tightly wound spring tube 1222, and the tip is a syringe needle tip structure 1221. The puncture tube 12 includes the implant 3. The proximal end of the metal tube is a seamless steel tube, which ensures its rigidity. The middle section is a laser-cut section on the seamless steel tube, which has both a certain degree of rigidity and flexibility, allowing it to perform a certain degree of bending. The distal end is a tightly wound spring tube, which is more flexible and easier to bend and twist than the laser-cut thiocyanate tube. The tip is a spring tube with an increased pitch, and the very tip is ground into a triangular facet to form a sharp angle.

[0092] In the method of the present invention, as one of the implementation schemes, the inner layer is a push tube 13, which is composed of a metal tube covering a heat-shrinkable protective tube 1332. The near end of the metal tube is a seamless steel tube 1333, and the far end is a tightly wound spring tube 1331.

[0093] In one embodiment of the present invention, an implant 3 is placed inside the puncture tube and at the front end of the push tube.

[0094] In one embodiment of the method of this invention, when the distal end of the tube reaches the target location, the tip of the screw-in can be screwed into the selected position of the valve annulus, gripping the valve annulus and providing precise positioning for subsequent puncture procedures. After the tip of the screw-in cannulus grips the valve annulus, the puncture tube and the push tube move forward together with the implant 3 until the valve annulus is punctured by the puncture tube, forming a channel between the atrium and ventricle. Afterwards, the puncture tube stops moving, and the push tube moves forward alone, pushing the implant out of the tube and anchoring it at the target location. (The repetition of the first paragraph is likely an error in the original text.)

[0095] In the method of this invention, as one of the implementation schemes, such as Figures 3-4 As shown, the implant consists of two parts: an anchoring portion 31 and a guide wire 32. The anchoring portion is a metal sheet structure with a threading hole, such as... Figure 3 As shown; the metal can be biocompatible stainless steel, nickel-titanium, or cobalt-chromium alloy, or a metal sheet covered with a more biocompatible textile; or it can be made directly from textiles. The anchoring portion can be straight, such as... Figure 3 As shown, it can also be foldable, such as... Figure 4 As shown. The suture is connected to the anchoring portion through a thread hole or directly sewn onto the fabric; the suture can be an ePTFE or polyester surgical suture.

[0096] In the method of this invention, as one of the implementation schemes, such as Figure 5 As shown, the handle can drive the tube body, enabling the anchoring of the implant. The insertion tube knob 21 can move the insertion tube forward or backward. Only after the locking pin 22 is removed can the puncture tube knob 23 and the push tube knob 25 rotate. When the linkage button 24 is in its initial position (raised), the puncture tube and push tube can be linked for control; that is, rotating the puncture tube knob or the push tube knob can move the puncture tube and push tube forward or backward together. When the linkage button is pressed, the linkage is released. At this time, the puncture tube knob can move the puncture tube forward or backward, and the push tube knob can move the push tube forward or backward.

[0097] In the method of the present invention, as one of the implementation schemes, when the control lever 26 is in the initial position, it can act as a transport brake, and the cable pull knob 27 will not rotate arbitrarily; at the same time, the cable pull knob can be forcefully rotated to tighten the cable 32, but when the control lever is fixed up, the cable pull knob can be rotated arbitrarily to release the cable.

[0098] In the method of this invention, as one of the implementation schemes, such as Figure 6 As shown, the screw-in tube knob has a countersunk hole at the front end with a guide opening, a small through hole in the middle, and a cavity with an internally threaded helix at the near end. The screw-in tube passes through the countersunk hole and the through hole at the far end, extending into the cavity. Glue is injected into the countersunk hole and the guide opening to connect the screw-in tube and the screw-in tube knob. The outer walls of the upper handle cover 28 and the lower handle cover 29 have externally threaded helical lines that match the helix of the screw-in tube knob cavity. When the handle is stationary, the screw-in tube knob can move the screw-in tube forward and backward along the helix of the thread.

[0099] In one embodiment of the present invention, the proximal end of the screw-in tube and the internal puncture and push tubes enter the screw-in tube sealing seat 41. The screw-in tube sealing seat consists of three parts: a distal cap, a main body, and a proximal cap. The distal cap, proximal cap, and main body can be connected by screws or adhesive. The proximal boss of the distal cap and the countersunk hole at the distal end of the main body form a cavity for placing a distal O-ring for sealing. The main body has side holes for connecting a tubing to inject saline or heparinized saline into the sealing seat to flush the inner lumen of the screw-in tube. The distal boss of the proximal cap and the stepped hole at the proximal end of the main body form a cavity for placing a silicone hemostatic valve for sealing.

[0100] In one embodiment of the method of the present invention, the screw-in tube, the puncture tube, and the push tube are not fixedly connected to the screw-in tube sealing seat. This ensures that the screw-in tube, the puncture tube, and the push tube can move back and forth when the sealing seat remains stationary.

[0101] In the method of this invention, as one of the implementation schemes, such as Figure 7As shown, the puncture tube 12 passes through the screw-in tube sealing seat 41, extends proximally to the puncture tube retaining ring 43, and is secured therein. The puncture tube retaining ring is placed in a groove in the puncture tube drive frame 42. The side of the puncture tube drive frame has a rack, and the bottom of the puncture tube knob 23 has gear teeth, allowing the two to drive each other.

[0102] In the method of this invention, as one of the implementation schemes, such as Figure 8 As shown, the push tube 13 passes through the screw-in tube sealing seat and the puncture tube retainer, is fixed to the push tube retainer 44, and its proximal end penetrates the inner cavity of the push tube sealing seat 46. The push tube retainer is placed in the groove of the push tube drive frame 45. The side of the push tube drive frame has a rack, and the bottom of the push tube knob 25 has gear teeth, and the two can be driven.

[0103] In one embodiment of the present invention, the proximal end of the push tube 13 enters the push tube sealing seat 46. The push tube sealing seat consists of three parts: a distal end cap, a main body, and a proximal end cap. The distal end cap, proximal end cap, and main body can be connected by screws or adhesive. The proximal countersunk hole of the distal end cap and the distal boss of the main body form a cavity for placing a distal O-ring for sealing.

[0104] Near the proximal end of the main body, there is a side hole for connecting a tubing to inject saline or heparinized saline into the sealing seat, used to flush the inner lumen of the delivery tube. The distal boss of the proximal cap and the stepped hole at the proximal end of the main body form a cavity for placing a silicone hemostatic valve for sealing.

[0105] In the method of the present invention, as one of the implementation schemes, the pull wire 32 part of the implant passes through the inner cavity of the push tube and extends out from the center hole of the proximal end cap of the push tube sealing seat to the pull wire module where the pull wire knob 27 is located.

[0106] In the method of this invention, as one of the implementation schemes, such as Figure 9 As shown, when the linkage button 24 is in the initial position (i.e., when it is pushed up), the teeth below the puncture tube knob 23, the linkage button 24, and the push tube knob 25 are in an engaged state, and the puncture tube and the push tube can be controlled in a linked manner.

[0107] In the method of this invention, as one of the implementation schemes, such as Figure 9 As shown, there is a horizontal through hole at the top of the linkage button, and a cylindrical beam 51 is placed inside the through hole. Deep blind holes are opened at both ends of the beam, and a small spring 53 is placed inside each blind hole. One end of the small spring contacts the bottom of the blind hole, and a metal ball 54 is placed at the other end. The metal ball, pushed by the small spring, will press against a recess in the handle cover. When the linkage button is in its initial position, the metal ball presses against the upper recess of the handle cover, and at this time, the large spring 52 at the bottom of the linkage button is in its original length and not compressed.

[0108] In the method of this invention, as one of the implementation schemes, such as Figure 10 As shown, when the linkage button is pressed, the small spring pushes the metal ball downwards until the metal ball is stuck in the recess at the lower end of the handle cover. At this time, the large spring at the lower end of the linkage button is compressed, and the teeth below the linkage button disengage from the teeth below the puncture tube knob and the push tube knob, allowing the puncture tube and the push tube to be controlled independently.

[0109] In the method of this invention, as one of the implementation schemes, such as Figure 11-12 As shown, the implant's pull wire 32 extends from the center hole of the proximal end cap of the push tube sealing seat and is wound around the spool 62. A non-standard involute toothed spool gear 63 is placed below the spool; the teeth are asymmetrical. When meshing with the teeth on the spool lock 61, it ensures that the gear drives the spool to rotate only in one direction, used for folding the foldable anchoring part of the implant. The implant is folded by tightening the pull wire; the part of the implant to be folded is pushed out of the puncture tube and folded at the beveled tip of the puncture tube. The spool knob 27 is placed above the spool 62, but is not fixedly connected; it is secured to the handle cover by the spool knob end cap 281, ensuring it cannot be moved arbitrarily.

[0110] The spool lock 61 is tightened onto the handle cover by a tension spring 64, ensuring that the teeth on the spool lock mesh with the teeth of the spool gear. When the implant has been placed at the target site, the upward undulating control lever 26 is fixed to the corresponding protrusion on the handle cover. At this time, the spool lock disengages from the spool gear, the entire instrument is retracted, and the spool rotates rapidly, causing the pull wire on the spool to separate from the spool.

[0111] In the method of this invention, as one of the implementation schemes, such as Figure 13 As shown, during tricuspid valve annular repair, the adjustable large sheath is first inserted through the right jugular vein and delivered to the right atrium. Once the distal end of the adjustable large sheath reaches the right atrium, the distal end can be adjusted using a knob on the handle. The bend is controlled to make the distal end of the sheath point as close as possible to the target location. Generally, the junction of the posterior and anterior leaflets on the valve annulus, and the junction of the septal and posterior leaflets are selected as target locations.

[0112] In this invention, as one of the embodiments, as shown in the appendix Figure 14 As shown, the adjustable smaller sheath and implant delivery device are inserted along the adjustable larger sheath. When the distal end of the adjustable smaller sheath extends beyond the distal end of the adjustable larger sheath, the knob on the handle of the adjustable smaller sheath is operated to precisely position the distal end of the smaller sheath at the target location. Then, the handle of the implant delivery device is operated to release the implant at the target location.

[0113] Typically, the target location is at least two points: the junction of the posterior and anterior lobes on the valve annulus and the junction of the septal and posterior lobes on the valve annulus. These points are used to fold the posterior lobes to achieve the effect of reducing the valve annulus size, thereby reducing the valve orifice area and decreasing regurgitation.

[0114] In the method of this invention, as one of the implementation schemes, as shown in the appendix... Figure 15 As shown, after positioning the adjustable small sheath at the target puncture site using the adjustable large sheath, the tube is screwed in and rotated to allow the spiral needle to puncture the valve annulus tissue from the atrial side.

[0115] In the method of this invention, as one of the implementation schemes, as shown in the appendix... Figure 16 As shown, the puncture tube enters the ventricle through the puncture annulus tissue on the atrial side, along the inner lumen of the screw-in tube and spiral needle.

[0116] In the method of this invention, as one of the implementation schemes, as shown in the appendix... Figure 17 As shown, the push tube pushes the implant along the puncture tube into the ventricle, completing the ventricular side implant deployment.

[0117] In the method of this invention, as one of the implementation schemes, as shown in the appendix... Figure 18 , attached Figure 19 As shown, the insertion cannula is retracted sequentially, the puncture cannula enters the adjustable bendable sheath, and the atrial implant is released, completing the deployment of the implant at one point at the puncture site. The second intended puncture site is located in the same manner, and the implant at the second point is deployed.

[0118] In the method of this invention, as one of the implementation schemes, such as Figure 20 , attached Figure 21 As shown, after all target points are anchored to the implant, the adjustable bend sheath and implant delivery device are withdrawn. Then, along the implant's guide wire, the instrument used to lock the implant is inserted into the adjustable bend sheath, releasing the locking body and locking the folded state of the posterior valve, i.e., the constricted state of the valve annulus.

[0119] As one implementation scheme, the device for locking the implant can be a commonly used device for locking implants in the art, including but not limited to the device for locking implants disclosed in patent 201310456429.7.

[0120] In the method of this invention, as one of the implementation schemes, such as Figure 22 , attached Figure 23 As shown, after the locking body is released, the instrument locking the implant is withdrawn from the adjustable curved sheath, and the instrument for cutting the suture is inserted into the adjustable curved sheath along the suture until the distal end of the cutting instrument contacts the locking body. The handle of the cutting instrument is controlled to cut the suture proximal to the locking body, thus completing the valve annulus retraction.

[0121] As one implementation scheme, the device for cutting and pulling the wire can be a commonly used device for cutting and pulling the wire in the field, including but not limited to the device for cutting and pulling the wire disclosed in patent 201420291000.7.

Claims

1. A method for applying an implant delivery device, characterized in that, The method includes using a delivery device to deliver an implant (3) to a target site and release the implant (3) at the target site, wherein the delivery device includes a handle (2) and a tube (1), the tube (1) containing the implant (3) is located at the distal end of the handle, the handle (2) drives the tube (1), and by operating the handle (2) pushes the tube (1) containing the implant (3) to the target site, the tube (1) releasing the implant (3).

2. The method according to claim 1, characterized in that, The tube body (1) includes a screw-in tube (11), a puncture tube (12) and a push tube (13), wherein the screw-in tube (11) is located in the outermost layer of the tube body (1), the puncture tube (12) is located in the middle layer of the tube body (1), the push tube (13) is located in the inner layer of the tube body (1), and the puncture tube (12) contains an implant (3).

3. The method according to claim 2, characterized in that, The screw-in tube (11) is composed of a metal tube covered with a heat-shrinkable protective tube (1115). Preferably, the metal tube includes a seamless steel tube (1116) at the near end, a laser-cut section (1113) on the seamless steel tube in the middle section, a tightly wound spring tube (1114) at the far end, and a spring tube (1112) with an increased pitch at the tip. Preferably, the tip of the screw-in tube is a triangular facet forming a sharp angle (1111).

4. The method according to claim 2, characterized in that, The puncture tube (12) consists of a metal tube covered with a heat-shrinkable protective tube (1223). The near end of the metal tube is a seamless steel tube (1224), the middle section is a tightly wound spring tube (1222), and the tip is a syringe needle tip structure (1221).

5. The method according to claim 2, characterized in that, The push tube (13) is composed of a metal tube covered with a heat-shrinkable protective tube (1332), with the near end of the metal tube being a seamless steel tube (1333) and the far end being a tightly wound spring tube (1331).

6. The method according to claim 2, characterized in that, The implant (3) is located inside the puncture tube (12) and at the front end of the push tube (13).

7. The conveying device according to claim 1, characterized in that, The implant (3) includes an anchoring component (31) and a pull wire (32). Preferably, the anchoring component (31) is a perforated metal sheet structure, a textile structure, or a textile-wrapped metal sheet structure. The pull wire (32) passes through the inner cavity of the push tube (13) and the proximal end cap center hole (101) of the push tube sealing seat (46) and is connected to the pull wire module (6) where the pull wire knob (27) on the handle (2) is located.

8. The method according to claim 4, characterized in that, The metal is stainless steel, nickel-titanium, or a cobalt-chromium alloy.

9. The method according to claim 4, characterized in that, The holes on the metal sheet are threading holes, through which the pull wire is connected to the anchoring part or directly sewn onto the textile and connected to the anchoring part; the anchoring part is straight or foldable; the pull wire is ePTFE or polyester surgical suture.

10. The method according to claim 1, characterized in that, The handle (2) includes a screw-in tube knob (21), a locking pin (22), a puncture tube knob (23), a linkage button (24), a push tube button (25), a control lever (26), a pull wire knob (27), a handle upper cover (28), and a handle lower cover (29).

11. The method according to claim 10, characterized in that, The screw-in tube knob (21) is located at the far end of the handle (2) and can drive the screw-in tube (11) forward or backward; the screw-in tube knob (21), the puncture tube knob (23), and the push tube button (25) control the tube body (1) to move forward or backward; the locking pin (22) controls the starting and closing of the screw-in tube knob (21) and the push tube button (25); the puncture tube knob (23) and the push tube button (25) can rotate in conjunction or rotate independently under the control of the linkage button (24); the control rod (26) is a brake that controls the rotation of the pull wire knob (27).

12. The method according to claim 10, characterized in that, The screw-in tube knob (21) has a countersunk hole (102) and a guide port (103) at its distal end, a small through hole (104) in the middle, and a cavity (105) with an internally threaded helix (106) at its proximal end. The screw-in tube (11) is inserted into the countersunk hole (102) at the distal end and extends into the cavity. Glue is injected through the countersunk hole (102) and the guide port (103) to fix the screw-in tube (11) and the screw-in tube knob (21) together. The outer walls of the handle upper cover (28) and the handle lower cover (29) are respectively provided with externally threaded helical lines that match the helix of the screw-in tube knob cavity. When the handle is fixed, the screw-in tube knob (21) drives the screw-in tube (11) to move forward and backward along the helix of the thread.

13. The method according to claim 10, characterized in that, The proximal end of the screw-in tube (11) and the internal puncture tube (12) and push tube (13) enter the screw-in tube sealing seat (41). The screw-in tube sealing seat (41) consists of a distal cap (107), a main body (108), and a proximal cap (109) of the screw-in tube sealing seat. The distal cap, proximal cap, and main body can be connected by screws or adhesive. The proximal boss (110) of the distal cap (107) and the countersunk hole (111) at the distal end of the main body (108) form a cavity for placing a distal O-ring for sealing. There is a side hole (112) on the main body for connecting a tubing to inject physiological saline or heparinized physiological saline into the sealing seat to flush the inner cavity of the screw-in tube (11). The distal boss (113) of the proximal cap (109) of the screw-in tube sealing seat and the stepped hole (114) at the proximal end of the main body form a cavity for placing a silicone hemostatic valve for sealing.

14. The method according to claim 10, characterized in that, The screw-in tube (11), puncture tube (12) and push tube (13) are not fixedly connected to the screw-in tube sealing seat (41), which ensures that the screw-in tube (11), puncture tube (12) and push tube can move back and forth when the screw-in tube sealing seat (41) remains stationary.

15. The method according to claim 10, characterized in that, The handle portion also includes a puncture tube drive frame (42), a puncture tube retainer (43), a push tube retainer (44), and a push tube drive frame (45); wherein, the puncture tube (12) passes through the screw-in tube sealing seat (41), and the proximal end extends to the puncture tube retainer (43) and is fixed thereon. The puncture tube retainer (43) is placed in the groove (115) of the puncture tube drive frame (42). The side of the puncture tube drive frame (42) has a rack (116), and the bottom of the puncture tube knob (23) has the tooth shape of a gear. The two mesh with each other to perform transmission.

16. The method according to claim 10, characterized in that, The push tube (13) passes through the screw-in tube sealing seat (41) and the puncture tube retainer (43) and is fixed to the push tube retainer (44), and the proximal end is inserted into the inner cavity of the push tube sealing seat (46). The push tube retainer (44) is placed in the groove (117) of the push tube drive frame (45). The side of the push tube drive frame (45) has a rack, and the bottom of the push tube knob (25) has the tooth shape of a gear. The two mesh with each other to carry out transmission. The push tube knob drives the push tube drive frame through the gear.

17. The method according to claim 10, characterized in that, The proximal end of the push tube (13) enters the push tube sealing seat (46); the push tube sealing seat (46) is composed of a distal end cap (118), a main body (119) and a proximal end cap (120) of the push tube sealing seat; the distal end cap, the proximal end cap and the main body can be connected by screws or glued; the proximal countersunk hole (121) of the distal end cap (118) and the distal boss (122) of the main body (119) form a cavity for placing a distal O-ring (123) for sealing; there is a side hole (124) near the proximal end of the main body for connecting a tubing to inject physiological saline or heparinized physiological saline into the sealing seat to flush the inner cavity of the push tube (13); the distal boss (125) of the proximal end cap (120) of the push tube sealing seat and the stepped hole (126) at the proximal end of the main body form a cavity for placing a silicone hemostatic valve for sealing.

18. The method according to claim 10, characterized in that, The pull wire (32) of the implant (3) passes through the inner cavity of the push tube (13) and extends out from the proximal end cap center hole (101) of the push tube sealing seat (46) to the pull wire module where the pull wire knob (27) is located.

19. The method according to claim 10, characterized in that, When the linkage button (24) is in the initial position, i.e., when it is pushed up, the teeth below the puncture tube knob (23), linkage button (24) and push tube knob (25) are in an engaged state, and the puncture tube (12) and push tube (13) are linked and controlled.

20. The method according to claim 10, characterized in that, The linkage button has a large spring (52) at the bottom and two sets of small springs (53) at the top. The linkage button has a gear structure inside. Preferably, the upper part of the linkage button (24) has a horizontal through hole (127) and a cylindrical beam (51) is placed in the through hole. The two ends of the beam (51) have deep blind holes (128) and a small spring (53) is placed in the blind hole. One end of the small spring (53) contacts the bottom of the blind hole (128) and the other end has a metal ball (54). The metal ball (54) is pushed by the small spring (53) and will push against the recess (129) of the handle cover (28). When the linkage button (24) is in the initial position, the metal ball (54) is pushed against the upper recess (129) of the handle cover (28). At this time, the large spring (52) at the lower end of the linkage button (24) is in its original length and is not compressed.

21. The method according to claim 10, characterized in that, When the linkage button (24) is pressed, the small spring (53) pushes the metal ball (54) downward together until the metal ball is stuck in the lower recess (130) of the handle cover (28); the large spring (52) at the lower end of the linkage button (24) is in a compressed state, and the teeth below the linkage button (24) disengage from the teeth below the puncture tube knob (23) and the push tube knob (25), so that the puncture tube (12) and the push tube (13) can be controlled separately.

22. The method according to claim 10, characterized in that, The handle portion is also provided with a pull-wire module (6) with a pull-wire knob at the proximal end. The pull-wire module (6) includes a pull wire, a spool (62), a spool gear (63), a spool lock (61), a tension spring (64), and a control rod (26). The pull wire (32) of the implant (3) extends out from the proximal end cap center hole (101) of the push tube sealing seat (46) and is wound around the spool (62). A non-standard involute toothed spool gear (63) is placed below the spool. The teeth are asymmetrical. When it meshes with the teeth on the spool lock (61), it ensures that the gear drives the spool to rotate in only one direction. This is used to fold the foldable anchoring part of the implant. The implant (3) is folded by pulling the pull line (32). At this time, the part of the implant (3) to be folded is pushed out of the puncture tube (12) and folded by pressing against the oblique opening at the tip of the puncture tube. The spool knob (27) is placed above the spool (62), but there is no fixed connection. It is fastened to the handle cover by the spool knob end cap (281) to ensure that it cannot be moved at will.

23. The method according to claim 10, characterized in that, The spool lock (61) is tightened on the handle cover (28) by a tension spring (64) to ensure that the teeth on the spool lock (61) mesh with the teeth of the spool gear (63); when the implant (3) has been implanted at the target position, the upward swing control lever (26) is fixed to the corresponding protrusion (131) on the handle cover (28); at this time, the spool lock (61) disengages from the spool gear (63), the entire device is retracted, and the spool will rotate rapidly to separate the pull wire (32) on the spool from the spool (62).

24. An application method of an implant delivery system, characterized in that, The method includes using an implant delivery system to deliver an implant (3) to a target site and release the implant (3) at the target site, wherein the implant delivery system includes the delivery device as described in any one of claims 1 to 23 and an adjustable bending sheath.

25. The method according to claim 24, characterized in that, The adjustable bending sheath includes an adjustable small bending sheath, an adjustable large bending sheath, or a combination thereof, preferably a combination of an adjustable small bending sheath and an adjustable large bending sheath.

26. The method according to claim 24 or 25, characterized in that, The implant delivery system includes the delivery device, adjustable sheath, and implant locking device as described in any one of claims 1 to 23.

27. The method according to claim 24 or 25, characterized in that, The implant delivery system includes the delivery device as described in any one of claims 1 to 23, an adjustable bending sheath, and a device for cutting and pulling wires.

28. The application method according to claim 24, characterized in that, The method involves first inserting an adjustable large sheath through the right jugular vein into the right atrium. Once the distal end of the adjustable large sheath reaches the right atrium, the distal end can be bent by rotating a knob on the handle. The bend is controlled to make the distal end of the sheath point as close as possible to the target location. Generally, the junction of the posterior and anterior leaflets on the valve annulus and the junction of the septal and posterior leaflets are selected as target locations.

29. The application method according to claim 28, characterized in that, The method includes positioning an adjustable small sheath at the target puncture site using an adjustable large sheath, and then rotating the tube to allow the spiral needle to puncture the valve annulus tissue from the atrial side.

30. The application method according to claim 29, characterized in that, The method involves inserting a puncture tube along the inner lumen of the screw-in tube and the spiral needle, and then puncturing the valve annulus tissue from the atrial side to enter the ventricle.

31. The application method according to claim 30, characterized in that, The method includes pushing the implant along the puncture tube into the ventricle to complete the ventricular implant deployment.

32. The application method according to claim 31, characterized in that, The method includes sequentially retracting the screw-in cannula, inserting the puncture cannula into the adjustable bendable sheath, and releasing the atrial-side implant, thus completing the deployment of an implant at one point at the puncture site. The second intended puncture site is located in the same manner, and the second implant is deployed.

33. The application method according to claim 26, characterized in that, The method includes anchoring the implant at the target location, withdrawing the adjustable bend sheath and implant delivery device, and sending an instrument for locking the implant into the adjustable bend sheath along the implant's pull wire, and releasing the locking body.

34. The application method according to claim 27, characterized in that, The method includes, after the lock body is released, withdrawing the device for locking the implant from the adjustable curved sheath, and sending the device for cutting the pull wire into the adjustable curved sheath along the pull wire until the distal end of the tube of the cutting device contacts the lock body, controlling the handle of the cutting device to cut the pull wire at the proximal end of the lock body.

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