Arioventricular valve opening area reduction system

Abstract

The invention relates to an atrioventricular valve opening area reduction system which comprises an anchoring device and an interventional puncture suturing system. The anchoring device comprises an anchoring piece, an anchoring wire and an anchoring conveying piece, wherein the anchoring piece is used for being anchored on the free wall of the atrium. The puncture suturing system comprises a catheter, two sets of puncture needles, a line body, a push-pull piece and a line catching device connected with the far end of the push-pull piece. The push-pull piece, the thread capturing device and the puncture needle are movably contained in the catheter. The anchoring device is movably contained in the conveying cavity of the push-pull piece. And the thread capturing device comprises two groups of movable arms which can be switched between an initial state and an unfolded state under the action of the push-pull piece. And each group of movable arms is provided with a thread capturing piece. And when the movable arm is in an unfolded state, each group of puncture needles is ejected from the puncture channel and then is clamped with one corresponding thread capturing piece. By adopting the area reduction system to repair the atrioventricular valve opening, the integrity of the anatomical structure of a patient can be restored to the maximum extent.

Description

Technical Field

[0001] The invention relates to the field of heart atrioventricular valve repair, and in particular to an atrioventricular valve orifice area reduction system. Background Art

[0002] Atrioventricular valve regurgitation is one of the most common lesions in heart disease. It manifests as: during the heart's systole, the blood in the ventricle flows backward to the atrial side, causing high pressure on the atrial side. In the long run, it will lead to the risk of valve ring enlargement and heart failure. Currently, one of the most commonly used methods for surgical repair of the mitral valve and tricuspid valve is to reduce the atrioventricular valve orifice area, so that the valve commissure edge moves backward, thereby achieving the effect of valve closure during heart systole.

[0003] Chinese patent document CN113317910A discloses a method and device for reducing the valve area through minimally invasive intervention. Figure 1 The principle of this method is to first puncture the atrial septum to form a gap; then use a transfemoral interventional surgery to implant a rivet 2 into the atrial free wall through the gap; implant an atrial septal occluder 3 in the gap to close the gap; use a tensioned wire 10 to pull the rivet 2 and the occluder 3, and use a locking piece 4 to knot the wire 10 on the proximal surface of the occluder 3, thereby making the leaflets 142 and 141 closer to each other than before the operation, thereby reducing the valve orifice area, that is, the area of ​​the opening between the leaflets 142 and 141.

[0004] This method has the following defects: 1. The occluder is made of metal braided wire with elastic deformation, and is elastic as a whole. However, the tension at the valve ring is relatively large. If the occluder is pulled for a long time, it is easy to cause the occluder to shift and then fall off, requiring open-chest surgery, which increases the patient's pain; 2. The occluder relies on two self-expanding umbrella discs and waist to clamp on the atrial septal notch. The umbrella discs and waist need to be clamped with the atrial septum to achieve a stable connection, but this clamping will continuously squeeze the atrial septum and cause atrial fibrillation, and implanting an occluder into the human body is equivalent to implanting a foreign body, which will increase the risk of thrombosis and the burden on the natural beating of the heart; 3. The waist of the occluder is inserted into the atrial septal notch, which will cause the atrial septum to be permanently unable to close, change the anatomical structure of the atrial septum, and inevitably cause changes in hemodynamics; 4. The occluder blocks the surgical access through the atrial septum. If the patient needs to undergo another atrial septal surgery, there are fewer sites left for puncture in the atrial septum, which will cause certain difficulties for the operation. Summary of the invention

[0005] In view of the shortcomings of the existing technology in reducing the area of ​​the atrioventricular valve orifice, it is necessary to provide a system for reducing the area of ​​the atrioventricular valve orifice. With this system, sutures can be used to suture the gap formed by atrial septal surgery, and the sutures are connected to the anchors on the atrial free wall through the anchors, which can reduce the pressure on the atrial septal tissue, avoid the risk of implanted foreign bodies falling into the heart, and restore the integrity of the patient's own anatomical structure to the greatest extent.

[0006] The atrioventricular valve orifice area reduction system provided by a technical solution of the present invention includes an anchoring device and an interventional puncture suturing system. The anchoring device includes an anchoring member for anchoring on the free wall of the atrium, an anchoring line with a distal end fixed to the anchoring member, and an anchoring conveying member detachably connected to the anchoring member. The puncture suturing system includes: two groups of puncture needles, a line body, a catheter, a push-pull member and a line catching device. The catheter includes a receiving cavity penetrating its distal end surface and two puncture channels located on both sides of the receiving cavity. The distal end of the puncture channel passes through the distal end circumference of the catheter, and each of the puncture channels accommodates a group of the puncture needles. The push-pull member can be movably accommodated in the receiving cavity and has a conveying cavity extending along its axial direction and penetrating the distal end surface of the push-pull member. The anchoring device can be movably accommodated in the conveying cavity. The line catching device is connected to the push-pull member and includes two groups of movable arms configured to switch between an initial state and an expanded state under the push-pull of the push-pull member. Each group of movable arms is provided with a wire catching member; when the two groups of movable arms are in the unfolded state, each group of puncture needles is engaged with a corresponding wire catching member after being ejected from the puncture channel.

[0007] In the atrioventricular valve orifice area reduction system provided by this technical solution, the interventional puncture and suturing system has a simple structure and can be delivered to the atrium through the femoral vein to suture the gap formed by the atrial septum surgery. The atrial septum tissue connection after suturing is stable and not easy to shift. In addition, the wire body for suturing the atrial septum gap occupies less space in the atrial septum, which is beneficial for the patient to undergo a transatrial septum surgery again. The anchoring member and the anchoring delivery member can be delivered to the atrium through the delivery cavity of the push-pull member of the puncture system without the need to use a separate delivery system for delivering the anchoring device. Therefore, it can avoid trauma to the patient caused by changing surgical instruments during surgery, saving operation time. Moreover, the anchoring line can be used as a guide wire for the atrioventricular valve orifice area reduction system, so that the atrioventricular valve orifice area reduction system can quickly and accurately find the atrial septal defect.

[0008] In the atrioventricular valve orifice area reduction system provided in one embodiment of the present invention, the wire-catching device includes a first limiter fixed to the distal end of the push-pull member, a second limiter fixed to the push-pull member and closer to the proximal side than the first limiter, and the two groups of movable arms. Each group of movable arms includes a first movable arm and a second movable arm, and the distal ends of the two first movable arms converge at the first limiter and are movably connected to the first limiter. The two ends of each second movable arm are movably connected to the proximal end of one of the first movable arms and the second limiter, respectively. Each second movable arm is provided with a wire-catching member.

[0009] In the atrioventricular valve orifice area reduction system provided by the present invention, the wire catcher can be fixed to the second movable arm, or can be located at the second movable arm and detached from the second movable arm under the action of an external force. In the embodiment in which the wire catcher is detachably connected to the second movable arm, the wire catcher can pass through the gap formed by the puncture needle in the atrial septum and drive the wire body to pass through the atrial septum as the puncture needle is withdrawn, so that the wire body can be knotted and fixed to each other at the gap in the atrial septum.

[0010] In the atrioventricular valve orifice area reduction system provided in one embodiment of the present invention, the engagement of the wire-catching member and the puncture needle adopts the following technical solution: the wire-catching member includes a wire-accommodating cavity and two spring pieces whose roots are connected to the peripheral surface of the wire-catching member, and the two ends of the wire body are accommodated in the wire-accommodating cavity. The suspended end of the spring piece is located in the wire-accommodating cavity, and is used to hold the needle head of the puncture needle.

[0011] In the atrioventricular valve area reduction system provided in one embodiment of the present invention, when both ends of the wire body are constrained by the two wire catching members, a portion of the wire body not constrained by the wire catching members can be accommodated at the distal end of the catheter.

[0012] In the atrioventricular valve orifice area reduction system provided by the present invention, the puncture needle may be a solid structure or a hollow structure.

[0013] In the atrioventricular valve orifice area reduction system provided in one embodiment of the present invention, the wire catcher is fixed to the second movable arm, and the two groups of puncture needles are hollow structures. The wire body is a puncture wire body. Each group of puncture needles includes a needle body, a needle head and a push rod. The needle body has a cavity, and the proximal end of the needle head and the push rod are accommodated in the cavity. The distal end of the puncture wire body is fixed in the needle head. The needle head is configured to be detached from the needle body under the push of the push rod after being engaged with the wire catcher.

[0014] In the atrioventricular valve orifice area reduction system provided in one embodiment of the present invention, the wire catcher is detachably arranged on the second movable arm. The wire body includes a suture and a puncture wire body. One of the two groups of puncture needles is a hollow structure, and the other group is a solid structure. Both ends of the suture are constrained by the wire catcher. The hollow puncture needle includes a needle body, a needle head and a push rod. The needle body has a cavity, and the proximal end of the needle head and the push rod are accommodated in the cavity. The distal end of the puncture wire body is fixed to the needle head. The needle head is configured to be detached from the needle body under the push of the push rod after being engaged with the wire catcher. The wire catcher is detached from the second movable arm after being engaged with the needle head, and moves with the suture and puncture wire when the puncture needle is withdrawn.

[0015] In the atrioventricular valve orifice area reduction system provided in one embodiment of the present invention, the catheter further has a wire delivery cavity. The central axis of the wire delivery cavity is parallel to the central axis of the accommodation cavity of the catheter. When at least one of the two groups of puncture needles is a hollow structure, that is, when the wire body also includes a puncture wire body, in an embodiment in which the distal end of the puncture wire body is fixed in the needle head of the puncture needle, the rest of the puncture wire body except for the part fixed to the needle head can be accommodated in the wire delivery cavity of the catheter or in the puncture channel.

[0016] The connection mode of the wire catching member and the second movable arm can be: the second movable arm is provided with a limiting hole located in the ejection path of the puncture needle, and the wire catching member is detachably located in the limiting hole.

[0017] As an example, in the atrioventricular valve area reduction system provided in one embodiment of the present invention, the limiting hole is a blind hole extending from the proximal end face to the distal end face of the second movable arm, and the blind hole includes a first blind hole and a second blind hole radially connected to the first blind hole, the shape and size of the first blind hole are consistent with the shape and size of the wire catching member, the wire catching member is detachably located in the first blind hole, the end of the suture thread close to the wire catching member is accommodated in the second blind hole, and passes through the proximal end face from the second blind hole to exit the second movable arm.

[0018] In the atrioventricular valve area reduction system provided in one embodiment of the present invention, the limiting hole includes a first through hole and a second through hole both penetrating the proximal end face and the distal end face of the second movable arm, the apertures of the first through hole and the second through hole both gradually decrease from the proximal end face of the second movable arm toward the distal end face of the second movable arm, and the angle between the central axis of the first through hole and the projection of its hole wall on the second movable arm is 0° to 70°, the wire catching piece is detachably located in the first blind hole, the end of the suture thread close to the wire catching piece is accommodated in the second through hole, and passes through the proximal end face of the second movable arm from the second through hole.

[0019] In an atrioventricular valve area reduction system provided in one embodiment of the present invention, the limiting hole includes a stepped through hole and a detour hole that both penetrate the proximal end face and the distal end face of the second movable arm, the stepped through hole includes a third through hole that penetrates the proximal end face and a fourth through hole that is connected to the third through hole and penetrates the distal end face, the aperture of the third through hole is larger than the aperture of the fourth through hole, the wire catching member is accommodated in the third through hole, the wire catching member is detachably located in the third through hole, the end of the suture thread close to the wire catching member is received in the fourth through hole and passes through the proximal end face from the detour hole to exit the second movable arm. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 The present invention is a schematic diagram of the principle of an atrioventricular valve orifice area reduction surgery provided by the prior art.

[0021] Figure 2 A schematic diagram of the structure of a system for reducing the atrioventricular valve area provided in one embodiment of the present invention.

[0022] Figure 3 To release in the left atrium Figure 2 A schematic diagram of the wire capture device of the atrioventricular valve orifice area reduction system is shown.

[0023] Figure 4 A schematic structural diagram of an invasive puncture and suturing system in an atrioventricular valve area reduction system provided in one embodiment of the present invention.

[0024] Figure 5 for Figure 4 The suturing system shown is a schematic diagram of a puncture needle and a push-pull member after a portion of the catheter is cut off along the radial direction of the catheter.

[0025] Figure 6 for Figure 4 Radial cross-section of the catheter of the suturing system shown.

[0026] Figure 7 This is a schematic diagram of the catheter after it is cut open along the axial direction after the wire-catching device is removed.

[0027] Figure 8 yes Figure 7 A partial enlarged schematic diagram of the structure encircled by a circle.

[0028] Fig. 9 for Figure 2 A cross-sectional view of the interventional puncture suturing system of the atrioventricular valve area reduction system is shown.

[0029] Fig.10 for Figure 2The schematic diagram of the initial state of the wire capture device of the atrioventricular valve orifice area reduction system is shown.

[0030] Fig.11 for Fig.10 Schematic diagram of the line catching device in the unfolded state.

[0031] Fig.12 for Fig.11 The schematic diagram shows the engagement between the puncture needle of the interventional puncture and suturing system and the thread-catching member of the thread-catching device.

[0032] Fig.13 for Fig.11 Schematic diagram of the wire catching member and suture thread of the wire catching device shown.

[0033] Fig.14 for Fig.12 A schematic diagram of the engagement between the puncture needle and the thread-catching member of the interventional puncture and suturing system is shown.

[0034] Fig.15 A schematic diagram of the three-dimensional structure of a second movable arm of an interventional puncture and suturing system provided in one embodiment of the present invention.

[0035] Fig.16 for Fig.15 A cross-sectional view of the second movable arm is shown.

[0036] Fig.17 A schematic diagram of the combination of a thread-catching member and a second movable arm of an interventional puncture and suturing system provided in one embodiment of the present invention.

[0037] Fig.18 A cross-sectional view of a second movable arm of the atrioventricular valve area reduction system provided in yet another embodiment of the present invention.

[0038] Fig.19 A schematic diagram of the combination of a thread-catching member and a second movable arm of an interventional puncture and suturing system provided in one embodiment of the present invention.

[0039] Fig. 20 A cross-sectional view of a second movable arm of the atrioventricular valve area reduction system provided in yet another embodiment of the present invention.

[0040] Fig.21 A schematic diagram of the combination of a thread-catching member and a second movable arm of an interventional puncture and suturing system provided in one embodiment of the present invention.

[0041] Fig. 22 Schematic diagram of implantation of an anchor into the free wall of the left atrium.

[0042] Fig.23 After implantation of the anchor, it is delivered to the left atrium Figure 2 Schematic diagram of the interventional puncture suturing system shown.

[0043] Fig.24 To expand in the gap of the atrial septum Figure 2 Schematic diagram of the wire catching device shown.

[0044] Fig.25 It is a schematic diagram of the engagement of the puncture needle and the wire-catching member after the puncture needle is ejected from the notch in the atrial septum.

[0045] Fig.26 For withdrawal Figure 2 Schematic diagram of the interventional puncture suture system where the posterior suture thread passes through the atrial septum and converges with the anchoring thread.

[0046] Fig. 27 Schematic diagram of suturing the atrial septal breach by tying the suture and anchoring thread at the atrial septal breach using a locking device.

[0047] Fig.28 This is a cross-sectional view of an interventional puncture and suturing system according to another embodiment of the present invention, with the wire-catching device in an expanded state.

[0048] Fig.29 for Fig.28 A cross-sectional view of a group of puncture needles of the interventional puncture and suturing system is shown.

[0049] Fig.30 for Fig.29 Schematic diagram of the puncture needle after ejection.

[0050] Fig.31 for Fig.30 Schematic diagram of the puncture wire ejected from the puncture needle and the suture wire constrained by the wire-catching piece passing through the atrial septum.

[0051] Fig.32 A schematic diagram of an interventional puncture and suturing system according to another embodiment of the present invention showing the puncture needle being removed when the thread-catching device is deployed.

[0052] Fig.33 for Fig.32 The schematic diagram shown is a diagram of the engagement of the needle tip with the thread-catching member after the puncture needle tip is ejected.

[0053] Fig.34 For withdrawal Fig.32 The schematic diagram of the interventional puncture suture system forming four puncture lines at the atrial septal notch is shown.

[0054] Fig.35 A schematic diagram of suturing the atrial septal gap by tying a puncture wire and an anchoring wire at the atrial septal gap using a locking piece. DETAILED DESCRIPTION

[0055] Many specific details are set forth in the following description so that those skilled in the art can fully understand the present invention. However, it is to be understood that the described embodiments are only some embodiments of the present invention, rather than all embodiments. The present invention can be implemented in many other ways than those described herein.

[0056] Unless otherwise defined, all technical terms and scientific terms used in this specification have the same meanings as those commonly understood by those skilled in the art to which the present invention belongs. The terms used in this specification are only for describing specific embodiments and are not intended to limit the present invention.

[0057] It should be noted that all directional indications in the embodiments of the present invention are only used to explain the relative position relationship, movement status, etc. between various components in a certain specific posture. If the specific posture changes, the directional indication will also change accordingly.

[0058] In addition, in the present invention, descriptions such as "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of the present invention, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0059] The technical solutions of the various embodiments of the present invention may be combined with each other, but this must be based on the fact that they can be implemented by ordinary technicians in the field. When the combination of technical solutions is contradictory or cannot be implemented, it should be deemed that such combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0060] In this specification, "distal end" and "proximal end" are commonly used terms in the field of medical devices, where "distal end" refers to the end away from the operator during surgery, and "proximal end" refers to the end close to the operator during surgery. Axial refers to the direction parallel to the line connecting the center of the distal end and the center of the proximal end of the component; radial refers to the direction perpendicular to the above axial direction.

[0061] An atrioventricular valve area reduction system 400 provided in one embodiment of the present invention includes: Figure 2 The anchoring device shown and Figure 2 and Figure 4 The puncture suturing system 100 is shown.

[0062] See also Figure 4 The puncture suturing system 100 comprises a catheter 10, a wire catching device 20, two sets of puncture needles 30, a wire body 40, and Figure 5 The push-pull member 50 is shown.

[0063] See also Figure 2 , Figure 4 and Figure 6 The catheter 10 has a receiving cavity 104 arranged along its axial direction and penetrating its distal end surface and proximal end surface, two puncture channels 102 located on both sides of the receiving cavity 104 and axially symmetrically distributed with respect to the receiving cavity 104, and two wire delivery cavities 105 axially symmetrically distributed with respect to the receiving cavity 104. The catheter 10 can be used to implement a transfemoral vein puncture intervention operation. The wire catching device 20 and the push-pull member 50 connected to the wire catching device can be delivered into the body and withdrawn from the body along the receiving cavity 104.

[0064] See also Figure 2 , Figure 6 and Fig. 9 The proximal end of the puncture channel 102 passes through the proximal end surface of the catheter 10, and the distal end thereof passes through the distal peripheral surface of the catheter 10. The axis of the puncture channel 102 is substantially parallel to the axis of the container 104. The needle outlet 101 of the puncture channel 102 passes through the distal peripheral surface 103 of the catheter 10. The puncture channel 102 is used to accommodate the puncture needle 30 and provide an ejection path for the puncture needle 30.

[0065] See also Figure 5 and Figure 7 Each set of puncture needles 30 is accommodated in a corresponding puncture channel 102. The line delivery cavity 103 is used to deliver the line body 40 into the body.

[0066] Please also read Figure 2 , Figures 5 to 8 The push-pull member 50 can be movably accommodated in the accommodating cavity 104 under the push-pull of external force. The push-pull member 50 is a hollow tubular structure, and has a conveying cavity 51 that passes through its proximal end surface and distal end surface.

[0067] See also Figure 2 and Figure 3 The anchoring device includes an anchoring member 5, an anchoring delivery member 52 and an anchoring line 60. The anchoring device can be movably accommodated in the delivery cavity 51 of the push-pull rod 50. The anchoring delivery member 52 is tubular, and its distal end is detachably connected to the anchoring member 5 by a thread. The distal end of the anchoring line 60 is fixedly connected to the anchoring member 5, and the other end thereof extends outside the body through the delivery cavity 51. The anchoring member 5 is used to anchor in the free wall of the atrium after passing through the atrial septum tissue through atrial septal puncture.

[0068] When it is necessary to implant the anchor 5 in the atrial free wall, the anchor 5 can be delivered to the predetermined position of the atrium through the atrial septal notch by the anchor delivery member 52 along the delivery cavity 51 of the push-pull member 50. Then, the anchor delivery member 52 is released from the anchor 5 to anchor the anchor 5 in the atrial free wall. Then, the anchor delivery member 52 is withdrawn from the body along the delivery cavity 51.

[0069] Please also read Fig. 9 and Fig.10 The wire catching device 20 includes a first stopper 21, a second stopper 24, a plurality of pins 27, two groups of movable arms and two wire catching members 28. The first stopper 21 and the second stopper 24 are both fixedly connected to the distal circumference of the push-pull member 50, and the second stopper 24 is closer to the proximal side than the first stopper 21. The first stopper 21 and the second stopper 24 can be fixedly connected to the push-pull member 50 by welding, interference connection or integrated processing.

[0070] Each group of movable arms includes a first movable arm 22 and a second movable arm 23. The distal ends of the two first movable arms 22 converge at the first limiter 21 and are movably connected to the first limiter 22 through a pin 27. The two ends of the second movable arm 23 are movably connected to the proximal end of the first movable arm 22 and the second limiter 24 through a pin 27. In this way, the two groups of movable arms are symmetrically arranged about the push-pull member 50. Each group of movable arms is configured to switch between an initial state and an expanded state under the push and pull of the push-pull member 50. The initial state refers to the state in which the first movable arm 22 is in the state in which the first movable arm 22 is in the state in which the second movable arm 23 is in the state in which the first movable arm 22 is in the state in which the second movable arm 23 is in the state in which the first movable arm 22 is in the state in which the second movable arm 23 is in the state in which the second movable arm 23 is in the state in which the first movable arm 22 is in the state in which the second movable arm 24 ...4 is in the state in which the second movable arm 24 is in the state in which the first movable arm 22 is in the state in which the second movable arm 24 is in the state in which the second movable arm 24 is in the state in which the second movable arm 24 is in the state in which the first movable arm 22 is in Fig. 9 and Fig.10 The natural state of the wire catching device 20 shown in the figure when no external force is applied. The unfolded state refers to the shape formed by the two sets of movable arms unfolding and cooperating when the push-pull member 50 pulls the first limit member 21 toward the second limit member 24 to the extreme position, such as Fig.11 and Fig.12 shown.

[0071] Please also see Fig.11 and Fig.12 The two thread-catching members 28 are respectively arranged on the two second movable arms 23, and can be separated from the second movable arms 23 under the action of pulling force. When the second movable arms 23 are in the unfolded state, the two thread-catching members 28 face the puncture needle 30 and are located on the ejection path of the puncture needle 30. Therefore, after the puncture needle 30 is ejected from the needle outlet 101, its needle head can be inserted into the thread-catching member 28.

[0072] For details, see Figures 11 to 13 The wire catching member 28 is in the shape of a circular tube, and a U-shaped groove is provided on its circumference, thereby forming a spring piece 281 connected to the root. The suspended end of the spring piece 281 is located in the wire holding cavity of the wire catching member 28 (not shown). The two ends of the wire body 40 are respectively constrained by a wire catching member 28.

[0073] See also Fig.14The puncture needle 30 includes a needle body 31 and a needle head 32 connected to the distal end of the needle body 31. The needle head 32 is roughly wedge-shaped and includes a protrusion 321. When the puncture needle 30 is ejected toward the wire-catching member 28, the suspended end of the spring piece 281 undergoes elastic deformation to hold the protrusion 321, thereby engaging the needle head of the puncture needle 30 with the wire-catching member 28. Also, when the puncture needle 30 is withdrawn from the body, the spring piece 281 undergoes elastic deformation again, and the wire-catching member 28 can be released from the second movable arm 23 and withdrawn together, while releasing the wire body 40.

[0074] There are various detachable connection schemes between the wire catching member 28 and the second movable arm 23. As an example, the second movable arm 23 may have a limiting hole located in the ejection path of the puncture needle 30, and the wire catching member 28 is located in the limiting hole.

[0075] For details, see Fig.11 , Fig.12 , Fig.15 and Fig.16 The second movable arm 23 provided in one embodiment of the present invention, in its unfolded state, includes a proximal end surface 731 facing the distal end 12 of the catheter 10. Unless otherwise specified, the proximal end surface and the distal end surface of the second movable arm referred to in this specification refer to two opposite surfaces of the second movable arm defined relative to the distal end of the catheter when the wire-catching member is transported to the outside of the distal end extending out of the catheter and in the unfolded state of the second movable arm. Among the two opposite surfaces, the surface closer to the distal end of the catheter is the proximal end surface.

[0076] See also Fig.15 The second movable arm 23 is provided with a blind hole from the proximal end surface 731 to the distal end surface opposite to the proximal end surface 731. The blind hole includes a first blind hole 7311 and a second blind hole 7312 radially connected to the first blind hole 7311. The shape and size of the first blind hole 7311 are consistent with the shape and size of the wire catching member 28. See 16 and Fig.17 The wire catching member 28 is detachably located in the first blind hole 7311. The end of the wire body 40 close to the wire catching member 28 is accommodated in the second blind hole 7312, and passes through the second movable arm 23 from the proximal end surface 731 after winding.

[0077] In another embodiment of the present invention, please refer to Fig.18 and Fig.19The limiting hole is a through hole that passes through the proximal end face 8331 and the distal end face 8332 of the second movable arm 833. The through hole includes a first through hole 8311 and a second through hole 8312. The apertures of the first through hole 8311 and the second through hole 8312 gradually decrease from the proximal end face 8331 to the distal end face 8332, and the angle between the central axis of the first through hole 8311 and the projection of its hole wall on the second movable arm 833 is 0° to 70°. The end of the wire body 140 close to the wire catching member 228 is accommodated in the second through hole 8311 and passes through the second through hole 8312 from the proximal end face 8331 to the second movable arm 833. In this way, it is possible to avoid squeezing the wire body 140 when the puncture needle is ejected and engaged with the wire catching member 228. When the puncture needle is engaged with the wire-catching member 228, the tapered hole wall of the first through hole 8311 blocks the wire-catching member 228 from moving further and preventing it from falling off.

[0078] In yet another embodiment of the present invention, see Fig. 20 and Fig.21 The limiting hole includes a stepped through hole and a detour hole 9313 that penetrate the proximal end face 9331 and the distal end face 9332 of the second movable arm 933. The stepped through hole includes a third through hole 9311 and a fourth through hole 9312 that is axially connected to the third through hole 9311. The third through hole 9311 extends from the proximal end face 9331 to the distal end face 9332, and the fourth through hole 9312 is coaxial with the third through hole 9311 and penetrates the distal end face 9332. The aperture of the third through hole 9311 is larger than the aperture of the fourth through hole 9312. The wire catching member 328 is accommodated in the third through hole 9311, and the end of the wire body 290 close to the wire catching member 328 is accommodated in the fourth through hole 9312 and passes through the second movable arm 933 from the detour hole 9313 and the proximal end face 9331. In this way, the wire body 290 can be prevented from being damaged when the puncture needle and the wire catching member 328 are engaged, and the wire body 290 extends along the detour hole 9313 to the outside of the second movable arm 933, so that the wire catching member 328 obtains a larger axial assembly amount, thereby preventing the proximal end of the wire catching member 328 from being exposed outside the second movable arm 933, thereby causing the surface of the instrument to be uneven and damaging tissue.

[0079] The wire body 40 is a flexible material with good biocompatibility, which can be a polymer material such as PP, PET, PTFE, or a metal material such as stainless steel, nickel-titanium alloy, etc. Fig.11 and Fig.12 As shown, a portion of the thread body 40 not constrained by the thread catcher 28 can be accommodated at the distal end of the catheter 10. Unless otherwise specified, in this specification, before the puncture needle and the thread catcher are engaged with each other, that is, before the puncture needle is ejected from the catheter, the thread body directly constrained at both ends by the thread catcher is defined as a suture thread, and the thread body directly connected to the puncture needle is defined as a puncture thread body.

[0080] To facilitate further understanding of the atrioventricular valve orifice area reduction system provided in this embodiment, the following uses the suture of a nick in an atrial septal surgery as an example to illustrate the practical application of the atrioventricular valve orifice area reduction system provided in this embodiment in reducing the mitral valve orifice area.

[0081] The atrioventricular valve orifice area reduction system provided by the present invention is applicable to the mitral valve orifice area reduction surgery, which includes: punching a hole in the atrial septum to form a gap; anchoring at least one anchoring member in the free wall of the left atrium through the gap, and a flexible anchoring line is fixedly connected to the anchoring member, and the anchoring line passes through the gap in the atrial septum to reach the right atrium; using a wire body to sew two free edges of the atrial septum gap, and tightening the wire body to close the atrial septum gap; using a locking member to fix the anchoring line and the wire body for suturing the atrial septum at the atrial septum gap, and at the same time, the anchoring line located in the left atrium has a certain tension, so that the free wall of the left atrium and the atrial septum are close to each other, thereby reducing the mitral valve orifice area.

[0082] For details, please refer to Figure 2 , Figure 3 and Fig. 22 First, a gap 2 is made in the atrial septum 3 using the existing technology, and the anchor 5 is delivered to the predetermined position of the atrium through the gap in the atrial septum using the anchor delivery member 52 along the delivery cavity 51 of the push-pull member 50. Then, the anchor delivery member 52 is released from the anchor 5, and the anchor 5 is implanted in the free wall of the left atrium. The anchor line 1 connected to the anchor 5 enters the right atrium along the gap in the atrial septum 2 and extends to the outside of the body along the catheter 10.

[0083] Secondly, see Fig.23 The puncture and suturing system 100 provided in this embodiment is transported along the femoral vein and the atrial septal notch 2 until the wire-catching device 20 reaches the left atrium and is located near the atrial septal notch 2 .

[0084] Again, see Fig.24 , pull the push-pull member 50 from the external handle end (not shown) toward the proximal end, drive the first limit member 21 along the axial direction of the push-pull member 50 to approach the second limit member 24, and the first movable arm 22 will rotate around the pin 27 with the second movable arm 23 until it is fully opened and in an expanded state and the second movable arm 23 is close to the atrial septum 3.

[0085] Then, see Fig.25 , driving the puncture needle 30, the puncture needle 30 is ejected from the catheter 10, pierces the atrial septum 3, and is engaged with the wire catching member (not shown) of the wire catching device 20.

[0086] The push-pull member 50 is pushed to the distal end of the handle outside the body, driving the first limit member 21 away from the second limit member 24 along the axial direction of the push-pull member 50, and the first movable arm 22 and the second movable arm 23 rotate around the pin 27 until the thread-catching device 20 returns to the initial state. Fig.25 and Fig.26 The two ends of the wire body 40 pass through the atrial septum and connect the free edges near the atrial notch 2.

[0087] Finally, see Fig. 27 The anchor wire 1 and the wire body 40 are fixed together at the atrial septal notch by using the locking member 7 of the prior art, and the two free edges are pulled tight, so as to close the atrial septal notch 2. It can be understood that under the pulling of the anchor wire 1, the free wall of the left atrium and the atrial septum are brought closer to each other, and the area of ​​the mitral valve orifice will be reduced, thereby achieving the purpose of the operation.

[0088] Compared with the prior art, the atrioventricular valve area reduction system provided in this embodiment can directly suture the gap in the atrial septum without the need to implant an occluder, which reduces the burden on the heart, reduces the risk of surgery, and brings greater benefits to patients. The implanted suture has a small area of ​​action on the atrial septum and exerts little pressure on the atrial septum, which can reduce the risk of damage to the atrial septum and causing atrial fibrillation, and is beneficial for patients to undergo another atrial septal surgery.

[0089] In the atrioventricular valve area reduction system provided by the present invention, the puncture and suturing system may have a structure different from the puncture and suturing system 100 described in the above embodiment, which is further explained below with examples.

[0090] See also Fig.28 Another embodiment of the present invention provides a puncture suturing system 200, which includes a catheter 210, a wire catching device 220, two sets of puncture needles 230, a suture 240, and a push-pull member (not shown). The structures of the catheter 210, the wire catching device 220, the suture 240, and the push-pull member are the same as the structures of the corresponding components in the puncture suturing system 100, and will not be described in detail.

[0091] See also Fig.28 and Fig.29 One of the two groups of puncture needles 230 has the same structure as the puncture needles 30 in the puncture and suturing system 100, that is, a solid structure, but the other group of puncture needles is a hollow split structure, having a cavity 233 arranged along its length direction, including a needle body 231 and a needle head 232. The proximal end of the needle head 232 is detachably accommodated in the cavity 233 of the needle body 231, which has a wire groove 2321. The distal end of the puncture wire body 250 is fixed in the wire groove 2321 of the needle head 232, and the other end is received in the puncture channel 211 of the catheter 210. In other embodiments of the present invention, the end of the puncture wire body 250 that is not connected to the needle head 232 can be received in the catheter such as Figure 5 and Figure 6 In the wire delivery cavity 105 shown.

[0092] The push rod 280 is accommodated in the inner cavity 233 of the needle body 231 and can move in the cavity 233 under the action of external force.

[0093] See also Figure 28 to Figure 31 After the puncture needle 230 is ejected, it can drive the puncture wire 250 to puncture the atrial septum 3 and then engage with the wire catcher 228. The push rod 280 is driven to push the needle 232 toward the distal end, and the needle 232 will be separated from the needle body 231. The puncture wire 250 is connected to the suture 240 through the needle 232 and the wire catcher 228. When the two groups of puncture needles 230 are withdrawn from the body, the suture 240 and the puncture wire 250 penetrate the two free edges 3 and connect the free edges 3 in series. The method of gathering all the wires at the atrial septum notch 2 and tightening the free edges 3 is the same as the first embodiment, and will not be repeated.

[0094] See also Figure 32 to Figure 35 A puncture suturing system 300 provided in another embodiment of the present invention includes a catheter 310, a wire catching device 320, two sets of puncture needles 340, a puncture wire body 330 and a push-pull member 350. The structures of the catheter 310, the wire catching device 320, the puncture wire body 330 and the push-pull member 350 are the same as the structures of the corresponding components in the puncture suturing system 100, and are not described in detail.

[0095] The structures of the two groups of puncture needles 340 are the same as the structure of the puncture needles 230 in the puncture and suturing system 200 provided in the second embodiment, that is, both are hollow structures and both include needle heads 332 that can be detached from the needle body under the action of external force, which will not be repeated here.

[0096] Different from the above-mentioned embodiment, the thread catcher 328 is fixed to the second movable arm 323. The thread catcher 328 of the thread catcher 320 does not constrain the suture thread, but instead, the distal end of the puncture thread body 330 is fixed in the needle 332, and the proximal end extends outside the body along the puncture channel.

[0097] After the two sets of puncture needles 340 are ejected, the needle head 332 cooperates with the wire catching member 328 and is released from the needle body. Fig.34 The initial state shown in the figure, then the wire-catching device 320 is withdrawn to the outside of the body through the atrial septal notch 2, and the puncture wire body 330 penetrates the atrial septum 3 to form four strands of wire bodies at the atrial septal notch 2. The four strands of wire bodies and the anchor (not shown in the figure, see Figure 2 ) anchor line (not shown, see Figure 3 ) The locking method at the atrial septum gap 2 is the same as that described in the first embodiment and will not be repeated here.

[0098] In the atrioventricular valve orifice area reduction system provided by the present invention, the anchoring device is accommodated in the puncture suturing system, and does not need to be separately delivered to the atrium by a delivery system, thereby avoiding trauma to the patient caused by replacing surgical instruments during surgery and saving surgery time. In addition, the anchoring line can be used as a guide wire for the atrioventricular valve orifice area reduction system, so that the atrioventricular valve orifice area reduction system can quickly and accurately find the atrial septal defect.

[0099] It is worth mentioning that the atrioventricular valve orifice area reduction system provided by the present invention is not only applicable to the repair of the mitral valve. For patients with only dilated tricuspid valve orifice area and normal mitral valve orifice area, an anchor and an anchor line can be implanted in the free wall of the right atrium, and the anchor line and the suture line for suturing the atrial septal notch are fixed at the atrial septal notch, thereby reducing the tricuspid valve orifice area.

[0100] For patients with dilated tricuspid and mitral valve orifice areas, an anchor and anchor line can be implanted in the right atrial free wall and the left atrial free wall respectively, and both sets of anchor lines can be fixed at the atrial septal notch with the sutures used to suture the atrial septal notch, thereby reducing the tricuspid valve orifice area and the mitral valve orifice area.

[0101] For large or complex atrioventricular valve dilatation, such as complex mitral valve dilatation, multiple anchors and anchor lines can be implanted at multiple locations on the left atrium free wall and then fixed at the atrial septal notch with the sutures used to suture the atrial septum to reduce the mitral valve area.

[0102] The above is only a preferred specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed by the present invention should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. A system for reducing the area of ​​an atrioventricular valve orifice, comprising an anchoring device, wherein the anchoring device comprises an anchoring member implanted in the free wall of an atrium and an anchoring wire whose distal end is fixed to the anchoring member, characterized in that: The atrioventricular valve orifice area reduction system further comprises an anchoring delivery member detachably connected to the anchoring member, and an interventional puncture and suturing system; the puncture and suturing system comprises: Two sets of puncture needles; Line body; The catheter comprises a receiving cavity penetrating the distal end surface of the catheter and two puncture channels located on both sides of the receiving cavity, wherein the distal ends of the puncture channels pass through the distal circumference of the catheter, and each of the puncture channels accommodates a group of the puncture needles; A push-pull member movably accommodated in the accommodation cavity, the push-pull member having a delivery cavity extending along its axial direction and penetrating through the distal end surface of the push-pull member, the anchoring device movably accommodated in the delivery cavity; and A wire catching device is connected to the distal end of the push-pull member, and the wire catching device includes two groups of movable arms configured to switch between an initial state and an expanded state under the push and pull of the push-pull member, and each group of the movable arms is provided with a wire catching member; when the two groups of movable arms are in the expanded state, each group of puncture needles engages with a corresponding wire catching member after being ejected from the puncture channel.

2. The atrioventricular valve area reduction system according to claim 1, characterized in that: The wire catching device includes a first limit piece fixed to the distal end of the push-pull piece, a second limit piece fixed to the push-pull piece and closer to the proximal side than the first limit piece, and the two groups of movable arms; each group of the movable arms includes a first movable arm and a second movable arm, the distal ends of the two first movable arms converge at the first limit piece and are movably connected to the first limit piece; the two ends of each second movable arm are respectively movably connected to the proximal end of one of the first movable arms and the second limit piece; each second movable arm is provided with a wire catching piece.

3. The atrioventricular valve area reduction system according to claim 2, characterized in that: The thread-catching member is detachable from the second movable arm; the thread body comprises a suture thread, both ends of which are respectively restrained by one of the thread-catching members; when the puncture needle engaged with the thread-catching member is withdrawn, the thread-catching member is detached from the second movable arm.

4. The atrioventricular valve area reduction system according to claim 3, characterized in that: The second movable arm is provided with a limiting hole located on the ejection path of the puncture needle, and the wire catching member is detachably located in the limiting hole.

5. The atrioventricular valve area reduction system according to claim 4, characterized in that: The limiting hole is a blind hole extending from the proximal end surface to the distal end surface of the second movable arm, and the blind hole includes a first blind hole and a second blind hole radially connected to the first blind hole, the shape and size of the first blind hole are consistent with the shape and size of the wire catching member, the wire catching member is detachably located in the first blind hole, the end of the suture thread close to the wire catching member is accommodated in the second blind hole, and passes through the proximal end surface from the second blind hole to the second movable arm.

6. The atrioventricular valve area reduction system according to claim 4, characterized in that: The limiting hole includes a first through hole and a second through hole both penetrating the proximal end face and the distal end face of the second movable arm, the apertures of the first through hole and the second through hole both gradually decrease from the proximal end face of the second movable arm toward the distal end face of the second movable arm, and the angle between the center axis of the first through hole and the projection of its hole wall on the second movable arm is 0° to 70°, the wire catching piece is detachably located in the first blind hole, the end of the suture thread close to the wire catching piece is accommodated in the second through hole, and passes through the proximal end face from the second through hole to exit the second movable arm.

7. The atrioventricular valve area reduction system according to claim 4, characterized in that: The limiting hole includes a stepped through hole and a detour hole that both penetrate the proximal end face and the distal end face of the second movable arm, the stepped through hole includes a third through hole that penetrates the proximal end face and a fourth through hole that is connected to the third through hole and penetrates the distal end face, the aperture of the third through hole is larger than the aperture of the fourth through hole, the wire catching member is accommodated in the third through hole, the wire catching member is detachably located in the third through hole, the end of the suture thread close to the wire catching member is received in the fourth through hole and passes through the proximal end face from the detour hole to exit the second movable arm.

8. The atrioventricular valve area reduction system according to claim 3, characterized in that: The thread-catching member comprises a thread-accommodating cavity and two spring pieces whose roots are connected to the peripheral surface of the thread-catching member. The two ends of the suture thread are accommodated in the thread-accommodating cavity. The suspended end of the spring piece is located in the thread-accommodating cavity and is used to hold the needle head of the puncture needle.

9. The atrioventricular valve area reduction system according to claim 3, characterized in that: A portion of the suture not constrained by the wire-catching member is accommodated at the distal end of the catheter.

10. The atrioventricular valve area reduction system according to claim 2, characterized in that: The wire catching member is fixed to the second movable arm, the wire body is a puncture wire body, and each group of puncture needles includes a needle body, a needle head and a push rod; the needle body has a cavity, and the proximal end of the needle head and the push rod are accommodated in the cavity; the distal end of the puncture wire body is fixed in the needle head; the needle head is configured to be detached from the needle body under the push of the push rod after being engaged with the wire catching member.

11. The atrioventricular valve area reduction system according to claim 3, characterized in that: One of the two groups of puncture needles includes a needle body, a needle head and a push rod; the needle body has a cavity, and the proximal end of the needle head and the push rod are accommodated in the cavity; the wire body also includes a puncture wire body, and the distal end of the puncture wire body is fixed to the needle head; the needle head is configured to be detached from the needle body under the push of the push rod after being engaged with the wire catching member.

12. The atrioventricular valve area reduction system according to claim 10 or 11, characterized in that: The catheter also has a wire delivery cavity, the central axis of which is parallel to the central axis of the puncture channel, and the portion of the puncture wire body that is not directly connected to the needle is accommodated in the wire delivery cavity or in the puncture channel.

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