Valve ring contraction device

Abstract

The invention relates to a valve ring contraction device which comprises a main body, an upper clamping arm, a lower clamping arm and a suture anchoring system, wherein the far end of the main body is provided with a guide head; the upper clamping arm is provided with two clamping holes; the lower clamping arm is provided with two first puncture channels; the two clamping arms are respectively and rotatably connected with the main body, and both have a closed state and an opened state. The suture anchoring system comprises a puncture needle, an anchoring piece capable of moving along with the puncture needle, a suture and a gasket. The distal end of the suture is connected to the anchor, and the proximal end of the suture constrains the shim. When the two clamping arms are in an open state, the needle outlets of the first puncture channel correspond to the clamping holes of the upper clamping arm in a one-to-one mode, and the puncture needles can be ejected out of the needle outlets and drive the anchoring pieces to penetrate through the clamping holes. The anchoring piece can be transversely clamped on the upper clamping arm by pulling the suture towards the near end or closing the upper clamping arm. The valve ring contraction device is easy to operate, and the risk that the valve ring is torn can be remarkably reduced.

Description

Technical Field

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

[0002] The mitral valve is a part of the heart that sits between the left atrium and the left ventricle. Blood is pumped from the left atrium into the left ventricle. When the left ventricle contracts to pump blood out to the body, the mitral valve closes to prevent blood from being pumped back into the left atrium. The mitral valve consists of anterior and posterior leaflets. The anterior leaflet is closer to the aorta, while the posterior leaflet is on the opposite side of the anterior leaflet. Both the anterior and posterior leaflets of the mitral valve are connected by chordae tendineae. When the left ventricle contracts, the chordae tendineae limit the upward movement of the anterior and posterior leaflets beyond their sealing point, ensuring that the mitral valve closes completely. In some people, the mitral valve does not close properly, causing blood to be pumped into the atrium every time the heart muscle contracts, a condition known as regurgitation.

[0003] The most common method for restoring damaged mitral valve function is surgical valve replacement or repair. These procedures require creating an opening in the patient's chest to access the heart, extracorporeal circulation, the use of a ring around the mitral valve, suturing it, or replacing the mitral valve with a mechanical valve. These procedures are highly invasive. Patients with mitral regurgitation are often relatively fragile, making surgical procedures high-risk.

[0004] Treatment through minimally invasive interventional surgery is the better choice for most heart valve diseases. Minimally invasive interventional surgery uses a vascular pathway in the human body or a tiny opening at the apex of the heart to deliver the device to the designated location through a catheter, or the device directly enters the designated location. The main treatment methods include artificial chord implantation, annuloplasty and valve edge-to-edge repair. Among them, annuloplasty is mainly used to treat mitral regurgitation caused by valve ring expansion. Annuloplasty mainly uses minimally invasive devices to shrink the expanded mitral valve annulus so that the anterior and posterior leaflets can effectively connect when the ventricle contracts, that is, to solve the problem of mitral regurgitation by shrinking the annulus.

[0005] Annular constriction can be performed directly or indirectly. Indirect constriction involves tightening the vascular tissue surrounding the mitral valve to constrict the mitral annulus. Direct constriction can be categorized as either direct constriction of the annulus with a ring or partial constriction of the annulus to reduce the size of the mitral annulus and tighten the mitral leaflets.

[0006] Chinese patent documents CN104000627B and CN204293210U disclose a tissue anchor and anchoring system that can be used for interventional mitral valve ring reduction surgery. Specifically, through the femoral artery approach, a radiofrequency interventional puncture wire is passed through the mitral valve ring into the left atrium using radiofrequency energy, and a catheter with a pair of long gauze strips is passed through the mitral valve ring along the radiofrequency interventional puncture wire into the left atrium. Half of the gauze is folded into a gasket at the atrium, and then passed through the valve ring, and the other half of the gauze is folded into a gasket in the ventricle. Two tensioning lines are left on both gauze strips to be attached to the catheter. A special lock is used to pull the tensioning line to achieve the desired folding effect of the mitral valve ring, and the lock is placed to maintain the folding of the mitral valve ring.

[0007] The surgical procedure using this tissue anchor and anchoring system is complicated, and only one puncture guidewire can be passed through the annulus at a time, which is inefficient. In addition, after puncturing the annulus with radiofrequency energy, a catheter with a gauze strip needs to be passed through the annular puncture hole. The catheter has a large diameter, resulting in a larger puncture hole in the annulus and a high risk of annular tearing. In addition, after the gauze strip passes through the annulus, it needs to be folded at the atrium and ventricle to play a fixing role, but the gauze will inevitably be squeezed into the annular puncture hole, making the puncture hole in the annulus larger, which also leads to a high risk of annular tearing. Summary of the Invention

[0008] The present invention provides a valve ring shrinking device to solve the technical problems of the existing valve ring shrinking device, such as complicated operation and high risk of valve ring tearing.

[0009] A valve ring shrinkage device provided by a technical solution of the present invention includes a main body with a guide head at the distal end, an upper clamp arm with two retaining holes, a lower clamp arm and a suture anchoring system. The lower clamp arm has two first puncture channels, and the upper clamp arm and the lower clamp arm are rotatably connected to the main body respectively, and both have a closed state and an open state. The suture anchoring system includes a puncture needle, an anchor member that can move with the puncture needle, a suture and a gasket, the distal end of the suture is connected to the anchor member, and the proximal end of the suture constrains the gasket. When the upper clamp arm and the lower clamp arm are in the open state, the needle outlet of the first puncture channel corresponds one-to-one with the retaining hole of the upper clamp arm, the puncture needle can be ejected from the needle outlet and drive the anchor member to pass through the retaining hole, and pulling the suture toward the proximal end or closing the upper clamp arm can cause the anchor member to be laterally retained in the upper clamp arm.

[0010] The annulus shrinking device provided by this technical solution has a simple structure and is easy to operate. It can simultaneously form two puncture incisions at the location where the annulus is to be shrinked. Sutures, which are much thinner than gauze, can effectively reduce the diameter of the delivery catheter, thereby reducing the size of the puncture incision and preventing tearing of the annulus. Furthermore, using this annulus shrinking device, two sutures can be passed through the annulus at once under the guidance of a puncture needle. The two sutures are locked and the annulus is reduced by pulling the sutures, resulting in a highly efficient procedure.

[0011] In an annulus ring reduction device provided by one embodiment of the present invention, the puncture needle has a cavity extending axially thereof, and the suture anchoring system further includes a push rod. The push rod and the anchor are both movably disposed within the cavity of the puncture needle. After the puncture needle is ejected and passes through the retaining hole, the push rod is used to push the anchor out of the needle tip of the puncture needle. This facilitates the proximal pulling of the suture or the closing of the upper clamp arm, allowing the anchor to laterally retain the retaining hole, thereby positioning the distal end of the suture on the annulus.

[0012] The gasket can be accommodated in the lower clamp arm or in the gasket groove on the back of the main body. The back of the main body refers to the surface opposite to the peripheral surface of the main body where the upper clamp arm and the lower clamp arm are installed.

[0013] In the valve ring shrinkage device provided by one embodiment of the present invention, the back side of the main body opposite to the upper clamping arm and the lower clamping arm is provided with a suture groove extending along the axial direction of the main body, and a gasket groove communicating with the suture groove, the suture passes through the suture groove, and the gasket is located in the gasket groove.

[0014] In the valve ring shrinking device provided in one embodiment of the present invention, in order to prevent the gasket from sliding off the main body, two blocking bars extending along the axial direction of the main body are further provided on the back side of the main body, and the two blocking bars are respectively pressed on the opposite ends of the gasket.

[0015] In the valve ring shrinkage device provided in another embodiment of the present invention, the surface of the lower clamping arm facing the main body is provided with a gasket groove and a wire passage communicating with the gasket groove, the gasket is placed in the gasket groove, and the proximal end of the suture passes through the wire passage.

[0016] There are various ways in which the proximal end of the suture constrains the gasket so that the gasket can move with it. For example, in the valve ring contraction device provided in one embodiment of the present invention, the proximal end of the suture passes through the gasket and is knotted on the proximal side of the gasket.

[0017] For example, in the valve ring shrinkage device provided in another embodiment of the present invention, the two free ends of the suture pass through the gasket in the same direction and are respectively connected to the anchoring members, and the U-shaped closed end of the suture constrains the gasket.

[0018] There may be only one or two upper clamping arms. In the valve ring shrinking device provided by one embodiment of the present invention, there is only one upper clamping arm, which is roughly L-shaped, including two connecting parts whose proximal ends are rotatably connected to the main body, and a clamping part connected to the distal ends of the two connecting parts. The two clamping holes are provided in the clamping part. When the upper clamping arm and the lower clamping arm are in the closed state, the lower clamping arm is embedded in the clearance groove formed by the two connecting parts. With such a design, the volume of the lower clamping arm can be reduced, thereby reducing the radial size of the distal end of the entire shrinking device, thereby reducing the size of the apical puncture port of the patient during subsequent surgery and reducing the surgical risk.

[0019] In the valve ring shrinking device provided in another embodiment of the present invention, the upper clamping arm is two, including a first clamping arm and a second clamping arm that is symmetrical with the first clamping arm about the main body axis, the first clamping arm and the second clamping arm both include a connecting portion with a proximal end rotatably connected to the main body via a rotating shaft, and a clamping portion connected to the distal end of the connecting portion, the clamping portion is provided with a positioning hole, and the central axes of the two rotating shafts form an angle. In this way, the distance between the positioning holes of the two clamping arms in the open state of the upper clamping arm can be increased (this distance is actually the distance between the two puncture holes formed on the valve ring during the subsequent operation), thereby increasing the distance between the two puncture holes formed on the valve ring during the subsequent operation, and further avoiding the risk of valve ring tearing caused by the two puncture holes being too close.

[0020] In the valve ring shrinkage device provided by one embodiment of the present invention, when the first clamp arm, the second clamp arm and the lower clamp arm are in the closed state, the lower clamp arm is embedded in the yield groove formed by the two connecting parts to reduce the volume of the lower clamp arm, thereby reducing the radial dimension of the distal end of the entire shrinkage device, thereby reducing the size of the apical puncture port of the patient during subsequent surgery and reducing the surgical risk.

[0021] There are also multiple ways to route the suture, depending on how the gasket is accommodated. In an embodiment of the present invention, the valve ring shrinkage device provided by the present invention comprises a gasket placed in a gasket groove of the lower clamping arm, the lower clamping arm further comprising a suture passage, the suture passage extending through the gasket groove, and the U-shaped closed end of the suture sequentially passing through the gasket groove and the suture passage from the distal end to the proximal end.

[0022] The opening and closing of the upper and lower clamp arms, as well as the suture anchoring system, can be controlled by a control system. In an embodiment of the present invention, the annulus shrinkage device further comprises a handle, an upper clamp arm control wire connected to the upper clamp arm, and a lower clamp arm control wire connected to the lower clamp arm, wherein the handle is used to tighten or loosen the upper and lower clamp arm control wires so that the upper and lower clamp arms have the open and closed states relative to the main body, and to control the movement of the puncture needle and the push rod.

[0023] The routing of sutures, upper and lower clamp arm control wires, and accommodation of puncture needles can be achieved by providing multiple channels in the main body. For example, in an annulus compression device provided by one embodiment of the present invention, the main body further has multiple channels that all pass through its proximal end and extend along its axial direction, and the multiple channels include two second puncture channels, an upper clamp arm control wire channel, and a lower clamp arm control wire channel.

[0024] In the valve ring shrinkage device provided in another embodiment of the present invention, the valve ring shrinkage device also includes a multi-lumen tube whose distal end is connected to the proximal end of the main body, and the multi-lumen tube has a plurality of cavities extending along its axial direction, and the plurality of cavities include two puncture cavities, an upper clamp arm control wire cavity, a lower clamp arm control wire cavity, and a suture cavity.

[0025] In the valve ring contraction device provided in another embodiment of the present invention, along the direction from the distal end to the proximal end, the upper clamp arm control wire sequentially passes through the upper clamp arm control wire channel and the upper clamp arm control wire cavity and is then connected to the handle, the lower clamp arm control wire sequentially passes through the lower clamp arm control wire channel and the lower clamp arm control wire cavity and is then connected to the handle, and the proximal end of the suture passes through the suture cavity. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the structures shown in these drawings without paying any creative work.

[0027] Figure 1 The structure diagram of the valve ring shrinking device provided by the first embodiment of the present invention is schematically shown;

[0028] Figure 2 The diagram schematically shows the structure of the main body, upper clamping arm and lower clamping arm of the valve ring shrinking device provided by the first embodiment of the present invention in a closed state;

[0029] Figure 3The diagram schematically shows the structure of the upper clamping arm and the lower clamping arm of the valve ring shrinking device provided by the first embodiment of the present invention in the open state;

[0030] Figure 4 A schematic structural diagram of the main body of the valve ring shrinking device provided in the first embodiment of the present invention;

[0031] Figure 5 for Figure 4 A schematic diagram of the structure of the main body shown from another perspective;

[0032] Figure 6 for Figure 4 A schematic structural diagram of the back side of the main body shown;

[0033] Figure 7 The structure diagram of the upper clamping arm of the valve ring shrinking device provided by the first embodiment of the present invention is schematically shown;

[0034] Figure 8 for Figure 7 A schematic cross-sectional structure diagram of the upper clamping arm shown;

[0035] Figure 9 The structure diagram of the lower clamping arm of the valve ring shrinking device provided by the first embodiment of the present invention is schematically shown;

[0036] Figure 10 for Figure 9 A schematic cross-sectional structure diagram of the lower clamping arm shown;

[0037] Figure 11 The structure diagram of the multi-lumen tube of the valve ring shrinking device provided by the first embodiment of the present invention is schematically shown;

[0038] Figure 12 The figure schematically shows the structure of the upper clamping arm of the valve ring shrinking device provided by the first embodiment of the present invention in the open state;

[0039] Figure 13 The structure diagram of the upper clamping arm and the control wire of the valve ring shrinking device provided by the first embodiment of the present invention is schematically shown;

[0040] Figure 14 The figure schematically shows the installation diagram of the upper clamping arm of the valve ring shrinking device provided by the first embodiment of the present invention;

[0041] Figure 15 The structure diagram of the puncture needle of the valve ring reduction device provided by the first embodiment of the present invention is schematically shown;

[0042] Figure 16 The structure diagram of the anchoring member of the valve ring annulus contraction device provided by the first embodiment of the present invention is schematically shown;

[0043] Figure 17 Schematically shows Figure 16 Schematic diagram of the assembly of the anchor and suture shown;

[0044] Figure 18 A schematic diagram of the puncture needle, suture and anchor of the valve ring reduction device provided by the first embodiment of the present invention relative to the upper clamping arm before the needle is removed is shown;

[0045] Figure 19 The diagram schematically shows the puncture needle of the valve ring reduction device provided by the first embodiment of the present invention after it is removed;

[0046] Figure 20 Schematically shows Figure 19 The schematic diagram of the puncture needle after the needle is removed is shown with the anchor member laterally clamped on the upper clamp arm;

[0047] Figure 21 A schematic diagram schematically illustrates one manner of constraining a suture gasket of a valve ring annulus reduction device provided by the first embodiment of the present invention;

[0048] Figure 22 A schematic diagram schematically shows another manner of constraining the suture gasket of the valve ring annulus reduction device provided by the first embodiment of the present invention;

[0049] Figure 23 A schematic diagram schematically illustrates a manner in which the sutures and gaskets of the valve ring annulus reduction device provided by the first embodiment of the present invention are constrained by the main body;

[0050] Figure 24 Schematic diagram showing another way in which the sutures and gaskets of the valve ring annulus reduction device provided by the first embodiment of the present invention are constrained by the main body;

[0051] Figure 25 Schematically shows a schematic diagram of a puncture needle having punctured a valve ring when the valve ring annulus retraction device provided by the first embodiment of the present invention is used for surgery with the upper and lower clamping arms in the open state;

[0052] Figure 26 A schematic diagram showing the anchor member being clamped in the upper clamp arm after puncture by a puncture needle during surgery using the valve ring reduction device provided by the first embodiment of the present invention is shown;

[0053] Figure 27 Schematically shows a schematic diagram of withdrawing the device during surgery using the valve ring contraction device provided by the first embodiment of the present invention;

[0054] Figure 28 Schematically shows a schematic diagram of delivering a locking member during surgery using the valve ring shrinkage device provided by the first embodiment of the present invention;

[0055] Figure 29 A schematic diagram of using a locking member to lock two sutures to shrink the valve ring during surgery using the valve ring shrinking device provided by the first embodiment of the present invention is shown;

[0056] Figure 30 A schematic diagram schematically illustrates the manner in which the sutures of the valve ring annulus contraction device provided by the second embodiment of the present invention constrain the gasket;

[0057] Figure 31 Schematic diagram showing the sutures and gasket of the valve ring annulus contraction device provided by the second embodiment of the present invention being constrained by the main body;

[0058] Figure 32 A schematic diagram of using a locking member to lock four sutures to shrink the valve ring during surgery using the valve ring shrinking device provided by the second embodiment of the present invention is shown;

[0059] Figure 33 A schematic diagram of the main body of the valve ring shrinking device provided by the third embodiment of the present invention is schematically shown;

[0060] Figure 34 A schematic diagram schematically illustrates the positional relationship between the connecting hole (rotating shaft) of the upper clamping arm and the main body of the valve ring shrinking device provided by the third embodiment of the present invention;

[0061] Figure 35 The following schematically shows the structure of the lower clamping arm of the valve ring shrinking device provided by the third embodiment of the present invention;

[0062] Figure 36 The diagram schematically shows the structure of the upper and lower clamping arms of the valve ring shrinking device provided by the third embodiment of the present invention in the open state;

[0063] Figure 37 The structure diagram of the upper clamping arm of the valve ring shrinking device provided by the third embodiment of the present invention is schematically shown;

[0064] Figure 38 The following schematically shows the structure of the lower clamping arm of the valve ring shrinking device provided by the third embodiment of the present invention;

[0065] Figure 39 The diagram schematically shows the structure of the upper and lower clamping arms of the valve ring shrinking device provided by the third embodiment of the present invention in a closed state;

[0066] Figure 40 The figure schematically shows the structure of the assembled suture, gasket and puncture needle of the valve ring shrinking device provided by the third embodiment of the present invention;

[0067] Figure 41A schematic diagram of removing a puncture needle with the upper and lower clamping arms open during surgery using the valve ring reduction device provided by the third embodiment of the present invention is shown;

[0068] Figure 42 Schematically shows a schematic diagram of an anchor member being clamped on an upper clamp arm during surgery using the valve ring reduction device provided by the third embodiment of the present invention;

[0069] Figure 43 The diagram schematically shows the valve ring contraction device provided by the third embodiment of the present invention after the upper clamp arm is closed during surgery;

[0070] Figure 44 The diagram schematically shows a diagram of the valve ring shrinkage device provided by the third embodiment of the present invention being used to withdraw the device and the gasket being attached to the valve ring during surgery.

[0071] Description of Figure Numbers:

[0072] Main body: 1, 211, 311; Multi-lumen tube: 2; Control system: 3; Upper clamp arm: 4; Lower clamp arm: 5, 350; Suture anchor system: 6; Puncture needle: 61, 361; Anchor: 62, 362; Suture: 63, 163, 363; Push rod: 65; Gasket: 64, 164, 364; Guide head: 11; Mounting surface: 111; Upper clamp arm connecting hole: 112; Lower clamp arm connecting hole: 113; Proximal end surface: 118; Proximal end surface: 119; End: 12; second puncture channel: 114; upper clamp arm control wire channel: 115; lower clamp arm control wire channel: 116; suture groove: 117; boss: 119; gasket groove: 120, 220, 320; puncture cavity: 21; upper clamp arm control wire cavity: 22; lower clamp arm control wire cavity: 24; suture cavity: 23, 323; distal end surface: 25; groove: 26; handle: 31; upper clamp arm control wire: 42; lower clamp arm control wire: 52; upper Clamp arm shaft: 41; lower clamp arm shaft: 51; connection part: 47, 347; clamping part: 48, 348; positioning hole: 43, 343; clearance groove: 371, 471; control wire fixing hole: 44; first shaft hole: 45; side of upper clamp arm close to lower clamp arm: 431; side of upper clamp arm close to main body: 432; first puncture channel: 53, 355; gourd channel: 55; lower clamp arm control wire connection hole: 54; second shaft hole: 5 6; limiting groove: 311; upper clamp arm control wire connecting hole: 32; control wire sleeve: 31; pushing cavity: 612; needle: 613; wire groove: 611; fixing hole: 621; locking piece: 70, 170; leaflet: 101; valve ring: 102, 301; delivery catheter: 71; baffle: 222; first clamp arm: 340; second clamp arm: 341; upper clamp arm connecting hole: 312; wire passage: 378; suture passage: 317. DETAILED DESCRIPTION

[0073] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0074] It should be noted that all directional indications in the embodiments of the present invention are only used to explain the relative position relationship and movement status of various components in a certain specific posture. If the specific posture changes, the directional indication will also change accordingly.

[0075] In addition, the terms "first," "second," and so on, used in this disclosure are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referenced. Thus, a feature specified as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of this disclosure, "plurality" means at least two, such as two or three, unless otherwise specifically defined.

[0076] In the present invention, unless otherwise specified or limited, the terms "connection" and "fixation" should be understood in a broad sense. For example, "fixation" can mean fixed connection, detachable connection, or integration; mechanical connection or electrical connection; direct connection or indirect connection through an intermediate medium; internal communication between two elements or interaction between two elements, unless otherwise specified. Those skilled in the art will be able to understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0077] In addition, the technical solutions between the various embodiments of the present invention can be combined with each other, but it must be based on the fact that ordinary technicians in this field can implement it. When the combination of technical solutions is mutually contradictory or cannot be implemented, it should be deemed that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0078] It should be noted that the terms "distal" and "proximal" are commonly used in the medical device field. "Distal" refers to the end away from the operator during surgery, while "proximal" refers to the end closer to the operator. Axial refers to the direction parallel to the line connecting the distal and proximal centers of the medical device; radial refers to the direction perpendicular to the axial direction.

[0079] Example 1

[0080] This embodiment provides an interventional mitral valve annulus reduction device for reducing the size of the mitral valve annulus, increasing the coaptation surface between the anterior and posterior leaflets of the mitral valve annulus, and treating mitral valve regurgitation.

[0081] See also Figures 1 to 3 The valve ring shrinking device provided in this embodiment includes a main body 1, a multi-lumen tube 2, a control system 3, an upper clamping arm 4, a lower clamping arm 5, and Figure 18 The suture anchoring system 6 shown in FIG. Wherein, the suture anchoring system 6 includes a puncture needle 61, an anchor 62, a suture 63, Figure 19 The push rod 65 shown, as Figure 21 The spacer 64 is shown.

[0082] See also Figure 2 The distal end of the main body 1 has a smooth guide head 11 with a conical arc surface, which facilitates entering the left ventricle from the apex during surgery and passing through the valve from the left ventricle to the left atrium, mainly playing a guiding role.

[0083] See also Figure 4 The circumference of the middle section of the main body 1 (referring to the area excluding the proximal and distal ends) includes a mounting surface 111, and is provided with an upper clamping arm connecting hole 112 and a lower clamping arm connecting hole 113. Figure 5 The main body 1 includes a proximal end face 118, and its proximal end 12 is designed with 8 channels, including two second puncture channels 114, two upper clamp arm control wire channels 115, two lower clamp arm control wire channels 116, and two suture grooves 117. The 8 channels extend along the axial direction of the main body and pass through the proximal end face 118. A boss 119 is provided in the central area of ​​the proximal end face 118 of the main body 1. The boss 119 is used to engage with the multi-lumen tube 2. In other embodiments, the number of channels in the main body can be set according to the number of control wires of the upper and lower clamp arms.

[0084] Please also see Figure 2 and Figure 6 The peripheral surface of the main body 1 where the upper and lower clamping arms are not installed, that is, the back surface opposite to the mounting surface 111, is provided with two gasket grooves 120 for placing Figure 21 The gasket 64 shown in FIG. 1 and two suture slots 117. The proximal end of each suture slot 117 ends at the gasket slot 120 and communicates with the gasket slot 120. Each suture slot 117 is used to provide Figure 17 and Figure 18 The suture 63 shown provides a movement channel and an accommodation space so that the suture 63 can pass along the suture groove 117 to the back surface opposite to the mounting surface 111.

[0085] Please also refer to Figure 1 、 Figure 5 and Figure 11, the distal end of the multi-lumen tube 2 is connected to the proximal end of the main body 1, and has a plurality of cavities that pass through along its axial direction. Specifically, the multi-lumen tube 2 is provided with two puncture cavities 21 respectively communicating with the second puncture channel 114 of the main body 1, two upper clamping arm control wire cavities 22 respectively communicating with the upper clamping arm control wire channel 115 of the main body 1, two lower clamping arm control wire cavities 24 respectively communicating with the lower clamping arm control wire channel 116 of the main body 1, and two suture cavities 23 respectively communicating with the suture groove 117 of the main body 1. The number of channels of the multi-lumen tube 2 corresponds to the number of channels of the main body 1. In this way, the second puncture channel 114 and the puncture cavity 21 cooperate with each other to provide an accommodating space and a movement path for the puncture needle, and the upper clamping arm control wire channel 115 and the upper clamping arm control wire cavity 22 cooperate with each other to provide a suture groove 117 of the main body 1. Figure 2 The upper clamp arm control wire 42 shown provides an accommodating space and a movement path, and the lower clamp arm control wire channel 116 and the lower clamp arm control wire cavity 24 cooperate with each other to provide the upper clamp arm control wire 42 with an accommodating space and a movement path. Figure 2 The lower clamp arm control wire 52 shown provides an accommodating space and a movement path, and the suture groove 117 and the suture cavity 23 cooperate with each other to provide the following Figure 17 and Figure 18 The suture 63 shown provides accommodation space and movement path. In addition, the central area of ​​the distal end face 25 of the multi-lumen tube 2 is provided with Figure 5 The boss 119 of the main body 1 is shown to be matched with the groove 26. The boss 119 is inserted into the groove 26 to achieve a snap connection between the proximal end of the main body 1 and the distal end of the multi-lumen tube 2.

[0086] The control system 3 includes: Figure 1 The handle 31 shown, Figure 2 The upper clamp arm control wire 42 and the lower clamp arm control wire 52 are shown. The handle 31 is used to tighten or loosen the upper clamp arm control wire 42 and the lower clamp arm control wire 52 to control the closing and opening of the upper clamp arm 4 and the lower clamp arm 5, and to control the movement of the puncture needle 61. In other embodiments of the present invention, the handle 31 is also used to control the movement of the push rod 65 in the puncture needle 61, that is, to advance and retract the push rod 65 relative to the puncture needle 61.

[0087] See also Figure 2 The upper clamping arm 4 is rotatably connected to the main body 1 via an upper clamping arm shaft 41, near the circumference of the main body 1 near the guide head 11. The lower clamping arm 5 is rotatably connected to the circumference of the main body 1 near the multi-lumen tube 2 via a lower clamping arm shaft 51. The upper clamping arm 4 and the lower clamping arm 5 can be closed and opened by rotating relative to the main body 1. The angles of the upper clamping arm 4 and the lower clamping arm 5 relative to the main body 1 can range from 0° to 150°.

[0088] Please also see Figure 2 、 Figure 3 、 Figure 7 and Figure 8The upper clamping arm 4 is L-shaped as a whole, including two connecting parts 47 and a clamping part 48. The proximal end of each connecting part 47 is connected to the main body 1 through the upper clamping arm shaft 41, and the distal ends of the two connecting parts 47 extend together to form a clamping part 48. The clamping part 48 has two locking holes 43 passing through its two opposite surfaces. Figure 7 The two connecting parts 47 are separated from each other to enclose a clearance groove 471, and the proximal end not directly connected to the clamping part 48 is provided with a control wire fixing hole 44 and a first shaft hole 45 for accommodating the upper clamping arm shaft 41. Figure 2 The upper clamp arm control wire 42 and the lower clamp arm control wire 52 shown can be fixed to the upper clamp arm 4 and the lower clamp arm 5 respectively, and the upper clamp arm 4 and the lower clamp arm 5 can be controlled to rotate relative to the main body 1 by tightening or loosening the upper clamp arm control wire 42 and the lower clamp arm control wire 52 through the handle 31, thereby controlling the opening and closing of the two clamp arms. The clearance groove 471 makes way for the lower clamp arm 5 when closing the upper and lower clamp arms, that is, Figure 2 The suspended end of the lower clamp arm 5 shown is accommodated in the clearance groove 471, which can shorten the length of the main body 1, avoid the main body 1 being too long and hitting the left atrium during surgery, and reduce the volume of the lower clamp arm 5, thereby reducing the radial size of the distal end of the entire ring contraction device, thereby reducing the size of the apical puncture port of the patient during subsequent surgery and reducing the surgical risk.

[0089] Please also see Figure 3 and Figure 8 The positioning hole 43 of the upper clamping arm 4 is a tapered hole, that is, the hole diameter of the side 431 close to the lower clamping arm 5 is larger than the hole diameter of the side 432 close to the main body 1, so as to facilitate the passage of the puncture needle. Figure 19 The axial length of the anchor member 62 shown is such that the anchor member 62 can be clamped laterally on the upper clamp arm 4.

[0090] Please also refer to Figure 3 、 Figure 9 and Figure 10 The lower arm 5 is also roughly L-shaped, with two first puncture channels 53 extending through its proximal and distal ends. These two first puncture channels 53 are roughly parallel to each other, with a diameter 0.1-0.3 mm larger than that of the puncture needle, to accommodate the passage of the puncture needle. The diameter of the first puncture channel 53 at the bend of the lower arm 5 is larger than that at other locations, forming a gourd-shaped channel 55, ensuring smooth passage of the rigid front end of the puncture needle.

[0091] In this embodiment, the upper clamping arm 4 and the lower clamping arm 5 are respectively rotated relative to the main body 1 by two control wires. In other embodiments, the upper clamping arm 4 and the lower clamping arm 5 can be designed to rotate relative to the main body 1 by only one control wire. When the upper and lower clamping arms are both opened, as shown in FIG. Figure 3As shown, the two positioning holes 43 of the upper clamping arm 4 are coaxially aligned with the two needle outlet holes (actually the first puncture channels) 53 of the lower clamping arm 5, ensuring that the puncture needle can accurately reach the positioning holes 43 of the upper clamping arm 4 when it is ejected.

[0092] The main body 1, the upper clamping arm 4 and the lower clamping arm 5 are machined from medical implantable metal materials, such as stainless steel, cobalt-chromium alloy and the like.

[0093] Please also see Figure 2 and Figure 9 The tail of the lower clamping arm 5 connected to the main body 1 is provided with a control wire connection hole 54 and a second shaft hole 56. The control wire connection hole 54 is used to accommodate Figure 2 The lower clamp arm control wire 52 shown, the second shaft hole 56 is used to Figure 2 The lower clamping arm rotating shaft 51 shown provides an accommodating space to realize the rotational connection between the lower clamping arm 5 and the main body 1 .

[0094] The upper clamp arm control wire 42 and the lower clamp arm control wire 52 can be made of the same material and are collectively referred to as the clamp arm control wire. Figure 12 As shown, the connecting portion 47 of the upper clamping arm 4 and the lower clamping arm 5 move in a direction away from the mounting surface 111 of the main body 1, and the two clamping arms are opened to the required angle, that is, in the open state. At this time, the locking hole 43 of the upper clamping arm 4 and the needle outlet 53 of the lower clamping arm 5 are as shown in FIG. Figure 3 Coaxial alignment shown.

[0095] The clamp arm control wire can be made of a single implantable metal material, such as stainless steel wire. Figure 13 As shown, the clamp arm control wire passes through the corresponding clamp arm control wire connection hole and is welded to the lower clamp arm 5, for example, by laser welding. In other embodiments, the clamp arm control wire can be made of 3-10 strands of implantable metal multi-strand wire, such as stainless steel multi-strand wire. Multi-strand wire is highly flexible, allowing it to bend easily when closing the clamp arm, reducing the pushing force.

[0096] Alternatively, the clamp arm control wire can be made of a single superelastic shape memory metal material, such as nickel titanium wire, which is first shaped into the angle required when the clamp arm is closed, that is, between 10° and 90°. When the clamp arm control wire and the corresponding clamp arm material are different, welding is not suitable, and limit grooves can be opened on both sides of the clamp arm. Taking the above clamp arm 4 as an example, see Figure 9 and Figure 14, the limiting groove 311 is coaxial with the upper clamping arm control wire connecting hole 32. There is another control wire sleeve 31, which is also made of superelastic shape memory metal material, such as nickel titanium wire. The control wire sleeve 31 is coaxial with the control wire connecting hole 32, and its inner diameter is smaller than the inner diameter of the control wire connecting hole 32, but larger than the outer diameter of the clamping arm control wire. The outer diameter of the control wire sleeve 31 is larger than the inner diameter of the control wire connecting hole 32, but smaller than the inner diameter of the limiting groove 311. The control wire sleeve 31 is placed in the limiting groove 311, and the upper clamping arm control wire 42 is passed through the control wire connecting hole 32 and into the control wire sleeve 31, and then the control wire sleeve 31 and the upper clamping arm control wire 42 are welded. In this way, the control wire sleeve 31 is accommodated and fixed in the limiting groove 311, and the distal end of the upper clamping arm control wire 42 is fixed to the upper clamping arm 4.

[0097] The puncture needle 61 in the suture anchoring system can be movably received in the lower clamping arm 5. Figure 9 and Figure 10 The puncture needle channel 53 shown in FIG. Figure 5 The second puncture channel 114 and the multi-lumen tube 2 are shown as Figure 11 The puncture cavity 21 shown enters and withdraws from the lower clamp arm 5. The puncture needle 61 is made by cutting an intervening metal material tube, such as a stainless steel tube. A sharp needle 613 is cut at the distal end of the puncture needle 61. The puncture needle 61 is also provided with a push cavity 612, and a wire groove 611 is provided near the needle 613 for making way for the suture 63 later. The distal 3-10 mm of the puncture needle 61 is a rigid section, which mainly serves to enhance the puncture force of the puncture needle. The puncture needle 61 is a flexible section at the middle end, which is cut with a spiral pattern to enhance the flexibility of the puncture needle, so that it can smoothly turn and move forward when the lower clamp arm 5 is opened.

[0098] Please also see Figures 16 to 18 The anchor 62 is a tubular structure with an outer diameter slightly smaller than the inner diameter of the puncture needle 61. It is coaxially housed in the push cavity 612 of the puncture needle 61 and close to the needle head 613. The anchor 62 has two opposite thread fixing holes 621 cut radially in the central area of ​​its circumference. That is, the central axis of the thread fixing hole 621 is perpendicular to the central axis of the push cavity 612. The distal end of the suture 63 is passed through and fixed to the anchor 62. The suture 63 is led out from the thread groove 611 near the end of the needle head 613, as shown in FIG. Figure 15 and Figure 18 shown.

[0099] Anchor 62 can be made of metal materials such as stainless steel, cobalt-chromium, nickel-titanium, etc. Suture 63 can be made of polypropylene (PP), polyester (PET), or ultra-high molecular weight polyethylene (UHMWPE). Suture 63 is inserted through one of the anchor holes 621 and exits through the other. The distal end of suture 63 can be secured to anchor 62 by either high-temperature melting to form a ball or by directly tying a knot.

[0100] See also Figure 19 Push rod 65 is movably disposed within the pushing cavity of puncture needle 61. Push rod 65 is made of a metal material, such as stainless steel wire, cobalt-chromium wire, or nickel-titanium wire. The distal end of push rod 65 can abut against the proximal end of anchor 62, thereby pushing anchor 62 out of puncture needle 61 after puncture needle 61 pierces the annular tissue and reaches the retaining hole 43 of upper clamp arm 4. When upper clamp arm 4 is closed or suture 63 is pulled proximally, anchor 62 will be laterally retained in retaining hole 43 of upper clamp arm 4.

[0101] The distal end of the suture 63 is connected to the anchor 62, and the other end passes through the spacer 64, which is constrained by the proximal end of the suture 63, as shown in FIG. Figure 21 The gasket 64 is placed in the Figure 6 and Figure 23 The gasket 64 is made of an implantable polymer material, such as nylon PA, polyester fiber PET, etc. The gasket 64 is cut into a rectangular shape. In the initial state, the proximal end of the suture 63 (the end not connected to the anchor 62) is connected to the anchor 62. Figure 5 The first puncture channel 114 of the main body 1 shown in FIG. Figure 6 and Figure 23 The suture groove 117 shown in FIG. 1 is formed by passing through the central area of ​​the gasket 64 and the knotted thread end is received in the multi-lumen tube 2 as shown in FIG. Figure 11 The suture cavity 23 is shown.

[0102] In other embodiments, the proximal end of the suture 63 can be constrained by the gasket 64 in the following manner: the proximal end of the suture 63 can be passed through the gasket 64 using a Figure 22 The positioning sleeve 68 shown is used for positioning. The positioning sleeve 68 is made of metal material, such as stainless steel. The inner diameter of the positioning sleeve 68 is slightly larger than the suture 63, and the wall thickness is about 0.5-2mm. Similarly, the suture thread end fixed by the positioning sleeve 68 is accommodated in the multi-lumen tube 2. Figure 11 When the distal end of the suture 63 is pulled by the anchor 62 , one end of the suture 63 having the retaining sleeve 68 fixed thereto will be pulled out along the suture cavity 23 of the multi-lumen tube 2 and then be retained on the gasket 64 .

[0103] The steps of performing surgery using the valve ring shrinkage device provided in this embodiment include:

[0104] First, make an apical stoma in the patient, insert the device into the left ventricle from the notch on the apex of the heart, pull the lower clamp arm control wire 52, open the lower clamp arm 5, and the lower clamp arm 5 passes through the mitral valve chordae tendineae, supports the mitral valve leaflets 101, and reaches the lower root of the mitral valve annulus 102. After that, pull the upper clamp arm control wire 42, open the upper clamp arm 4, and clamp the leaflets 101 between the upper clamp arm 4 and the lower clamp arm 5. Control the puncture needle 61 to pass through the lower clamp arm 5, pass through the valve annulus 102, and then pass through the positioning hole 42 of the upper clamp arm 4. Control the push rod 65 in the puncture needle 61 to push forward and push out the anchor 62. Control the puncture needle 61 to retract into the lower clamp arm 5. The puncture needle 61 will go down with the suture 63, tighten the anchor 62, and the anchor 62 will be clamped horizontally on the upper clamp arm 4, as shown Figure 25 shown.

[0105] Move the upper clamp arm 4 to the second position of the valve ring 102 that needs to be retracted, control another set of puncture needles 61 to pass through the lower clamp arm 5, and then pass through the valve ring and through the positioning hole 43 of the upper clamp arm 4. Control the push rod 65 in the puncture needle 61 to push forward to push out the anchor 62. Control the puncture needle 61 to retract into the lower clamp arm 5. The puncture needle 61 will move downward with the suture 63, tighten the anchor 62, and the anchor 62 will be stuck horizontally on the upper clamp arm 4. Then push the upper clamp arm control wire 42 to close the upper clamp arm 4. The upper clamp arm 4 will pull the two sutures 63 toward the atrial side, see Figure 26 .

[0106] Withdraw the device toward the apex of the heart. When it is close to the apex of the heart, close the lower clamp arm 5 to prevent the lower clamp arm 5 from clamping the valve leaflet or chordae tendineae. Figure 27 As shown. Then the device is withdrawn from the heart, and the upper clamp arm 4 takes the suture with one end of the anchor 62 out of the body. Figure 6 The anchor is removed from the receiving groove shown, the suture at the end of the anchor is cut, and the suture is pulled to pull the gasket 64 under the valve ring 102, as shown in FIG. Figure 28 One end of the suture 63 with the anchor 62 remains outside the body.

[0107] Finally, use the existing locking member delivery catheter 71 to push the existing locking member 70 along the two sutures 63 to the left atrium, as shown in FIG. Figure 29 The two sutures 63 are tightened, and after the locking member locks the sutures 63, the sutures are cut. At this time, the valve ring will produce wrinkles 102a under the pull of the two sutures 63, thereby shrinking the mitral valve ring.

[0108] The annulus reduction device provided in this embodiment has a simple structure and is easy to operate. It replaces the gauze strips with sutures of a much smaller diameter than in existing techniques, reducing the diameter of the delivery catheter and creating a smaller puncture hole in the annulus, thus preventing annular tearing. Furthermore, the annulus reduction device allows two sutures to be passed through the annulus at once under the guidance of a puncture needle. The two sutures are then locked and the annulus is reduced by pulling the sutures, resulting in a highly efficient procedure.

[0109] Example 2

[0110] The annulus contraction device provided in this embodiment has a similar structure to that provided in the first embodiment, differing in the manner in which the sutures constrain the gasket and the structure on the back of the body for accommodating the gasket. The annulus contraction device provided in this embodiment shares the same structure as that provided in the previous embodiment and will not be further described here.

[0111] Compared with the embodiment 1 Figure 21 and Figure 22 The difference between the structures shown is that in the valve ring shrinking device provided in this embodiment, see Figure 30 The two free ends of the suture 163 pass through the gasket 164 in the same direction and form a U-shaped closed section at the proximal end.

[0112] See also Figure 31 , there are stop bars 222 at the left and right ends of the gasket groove 220 on the back of the main body 211. The gasket 164 is laid flat in the gasket groove 220 along the axial direction of the main body 211. The stop bars 222 press the gasket 164 to prevent the gasket 164 from falling out of the gasket groove 220. The two free ends of the suture 163 are on the outside of the gasket 164 and the main body 211, and are connected to the following after passing through the gasket 164: Figure 3 The lower clamp arm 5 shown in FIG. Figure 18 The U-shaped closed section of the suture 163 is located between the spacer 164 and the body 211 and is assembled to the anchor 62 in the two puncture needles 61 shown. Figure 11 In the suture lumen 23 of the multi-lumen tube 2 shown.

[0113] The steps for using the valve ring shrinking device provided in this embodiment are basically the same as those in the first embodiment, except that, after the lower clamp arm reaches the lower root of the mitral valve ring, the two puncture needles are controlled to pass through the lower clamp arm at the same time, and after passing through the valve ring, they pass through the positioning hole of the upper clamp arm. At the same time, the push rods in the two puncture needles are controlled to push forward to push out the anchor. The puncture needles are controlled to retract into the lower clamp arm, and the puncture needles will move downward with the suture, tighten the anchor, and the anchor will be stuck horizontally on the upper clamp arm. After closing the upper clamp arm and withdrawing the shrinking device from the heart, the gasket is removed from the device, the suture at the anchor end is cut, and the suture is pulled to pull the gasket under the valve ring inside the heart, and the end of the suture with the anchor remains outside the body.

[0114] Then, using another set of devices identical to the annulus shrinking device provided in this embodiment, two more sutures and a spacer are implanted at another location of the annulus that requires shrinking, as described in the previous paragraph. Finally, the locking member delivery catheter is used to push the locking member 170 along the four sutures to the left atrium. After tightening the four sutures and locking the sutures with the locking member 170, the sutures are cut. Figure 32 shown.

[0115] When performing surgery using the annulus contraction device provided in this embodiment, since four sutures are used to contract the mitral valve, the force on the annulus can be effectively dispersed, and each gasket uses one suture to pass through in a U-shape to become two sutures, which can prevent the suture from being pulled off the gasket and the gasket from being pulled through the annulus through the puncture hole of the annulus.

[0116] Example 3

[0117] The annulus shrinking device provided in this embodiment has a similar structure to that provided in Example 2, except that it has two upper clamping arms, two puncture needles protrude from the sides of the lower clamping arms, and a gasket is installed within the lower clamping arms. The annulus shrinking device provided in this embodiment has the same structure as that provided in Example 2 and will not be described in detail here.

[0118] For details, see Figure 33 and Figure 34 In this embodiment, the upper clamping arm includes a first clamping arm 340 and a second clamping arm 341 which is symmetrical with the first clamping arm 340 about the axis of the main body 311. The first clamping arm 340 and the second clamping arm 341 have the same Figure 3 and Figure 7 The upper clamp arm 4 shown in FIG. 4 is similar in structure and is L-shaped as a whole, including a connecting portion 347 connected to the periphery of the main body 311 at a proximal end, and a clamping portion 348 connected to the distal end of the connecting portion 347. The proximal end of each connecting portion 347 is accommodated in a Figure 36 The upper clamp arm shaft ( Figure 36 Not shown) is connected to the main body 311.

[0119] Each clamping portion 348 has a locking hole 343 extending through two opposite surfaces thereof. Figure 33 、 Figure 34 、 Figure 36 and Figure 39 The two connecting parts 347 are separated from each other to form a clearance groove 371. The clearance groove 371 can be used to make way for the lower clamping arm 350 when closing the upper and lower clamping arms, that is, Figure 39 The suspended end of the lower clamping arm 350 is shown to be received in the clearance slot 371 .

[0120] See also Figure 35 and Figure 36The middle section of the main body 311 (the portion between the proximal end and the distal end of the main body 311) is provided with an upper clamping arm connection hole 312. A rotating shaft in the upper clamping arm connection hole 312 in the main body 311 is inserted into the first clamping arm 340 and the second clamping arm 341, and the first clamping arm 340 and the second clamping arm 341 are rotatably fixed to the main body 311 to realize the opening and closing of the upper clamping arm. It is understandable that, if Figure 36 The two upper clamping arm connecting holes 312 are spaced apart from each other, and their central axes are angled relative to each other. This design allows the two locking holes 343 to be spaced relatively close together when the two upper clamping arms are closed, and to be spaced apart when the two upper clamping arms are opened. The angle formed by the two upper clamping arm connecting holes 312 is determined by the distance between the two upper clamping arms when they are opened. The main body 311 is also provided with a suture groove 317 for passing sutures from the upper clamping arms to the clamping arms. Figure 33 The lower clamping arm 350 is shown extending to the back of the main body 311.

[0121] Please also refer to Figure 33 and Figure 37 、 Figure 38 The distal end of the lower clamping arm 350 is designed to be smooth to prevent damage to the valve ring when it is pushed under the valve ring. The surface of the lower clamping arm 350 facing the main body 311 has a gasket groove 320 for placing a gasket. The length of the gasket groove 320 is about 0.5 to 2 mm larger than the width of the gasket, and the width is about 0.5 to 3 mm larger than the thickness of the gasket, ensuring that the suture can slide smoothly inside. The depth of the gasket groove 320 is about 0.5 to 2 mm larger than the length of the gasket. The lower clamping arm 350 is also provided with a wire channel 378 that communicates with the gasket groove 320, through which the suture can reach the main body 311. Figure 5 The suture groove 117 shown. The lower clamp arm 350 is provided with two first puncture channels 355 extending along its length. The overall diameter of each first puncture channel 355 is 0.1-0.3mm larger than the puncture needle. When the lower clamp arm 350 is closed, the side that is in contact with the main body 311 is the front of the lower clamp arm. When viewed from the side, the distal ends of the first puncture channels 355 are offset in the direction close to the gasket groove 320. When viewed from the front, the two first puncture channels 355 are offset in the direction away from each other at the distal ends, as shown in FIG. Figure 39 The two first puncture channels 355 are separated from each other at the distal end, so that the width of the lower clamping arm 350 can be reduced as much as possible, and the lower side of the valve ring can be smoothly penetrated through the chordae tendineae.

[0122] like Figure 39As shown, when the first clamp arm 340 and the second clamp arm 341 are in the open state, the distance between the two upper clamp arms becomes larger, the lower clamp arm 350 opens, and the needle outlets of the two first puncture channels 355 correspond one-to-one with the positioning holes 343 of the first clamp arm 340 and the second clamp arm 341, so that after the puncture needle comes out of the first puncture channel 355 of the lower clamp arm 350, it can pass through the valve ring and directly reach the positioning hole 343 of the upper clamp arm.

[0123] This design can increase the needle exit distance of the two puncture needles without increasing the distal outer diameter of the valve ring shrinkage device provided in this embodiment, and thus increase the distance between the puncture holes formed by the two groups of puncture needles on the valve ring. It can disperse the force on the valve ring as much as possible, and avoid excessive concentration of force on the valve ring when the suture is locked, which may cause the two puncture holes to tear and merge into one large hole.

[0124] The gasket can be placed vertically in the gasket groove 320 of the lower clamp arm 350. The way the stitches 363 restrain the gasket can be seen in Figure 30 As shown, the two free ends of a suture respectively pass through the gasket from the end close to the puncture needle and come out from the side of the gasket close to the main body. Figure 17 and Figure 18 As shown, after being connected with the anchor, it is assembled into a puncture needle. The U-shaped closed end of the suture enters the main body 311 along the wire channel 378 of the lower clamping arm 350. Figure 41 The suture channel 317 shown in FIG. Figure 41 The suture lumen 323 of the multi-lumen tubing is shown.

[0125] The steps of performing surgery using the valve ring shrinkage device provided in this embodiment include:

[0126] After the apical stoma is made, the device is inserted into the left ventricle from the apex of the heart. The lower clamp arm control wire is pulled to open the lower clamp arm 350. The lower clamp arm 350 passes through the mitral valve chordae tendineae, supports the mitral valve leaflets, and reaches the lower root of the mitral valve ring. After that, the upper clamp arm control wire is pulled to open the two upper clamp arms at the same time, clamping the valve leaflets between the upper clamp arm and the lower clamp arm 350. Figure 41 As shown. The two puncture needles 361 are controlled to pass through the lower clamp arm 350, pass through the valve ring 301, and then pass through the positioning hole 343 of the upper clamp arm. While the two puncture needles 361 drive the sutures 363 at both ends to pass through the valve ring 301, since the sutures at both ends are folded and pass through the gasket 364, the force on the sutures at both ends will pull the gasket 364 out of the accommodating groove of the lower clamp arm 350. Then the push rod in the puncture needle 361 is controlled to push forward to push out the anchor 362. The puncture needle 361 is controlled to retract into the lower clamp arm 350. The puncture needle 361 will move downward with the suture 363 to tighten the anchor 362. The anchor 362 is clamped horizontally on the upper clamp arm, as shown. Figure 42 shown.

[0127] Then push the upper clamp arm control wire to close the upper clamp arm, and the upper clamp arm pulls the two sutures 363 to move toward the atrial side. At this time, the U-shaped closed end of the suture 363 drives the gasket 364 to be pulled out along the suture channel until it is close to the lower side of the valve ring 301. Figure 43 and Figure 44 shown.

[0128] The gasket 364 is directly disengaged from the lower clamping arm 350 and reaches under the valve ring 301, which can effectively prevent the gasket 364 from getting caught on the chordae tendineae during the process of being pulled from outside the heart to under the valve ring.

[0129] The device is withdrawn toward the apex of the heart. Once close to the apex, the lower clamp arm 350 is closed to prevent the lower clamp arm 350 from clamping the valve leaflets or chordae tendineae. The suture at the anchor end is then cut outside the heart.

[0130] Next, another set of the annulus shrinking device provided in this embodiment is used, and the same method is used to sew two more sutures and a spacer at the next location of the annulus to be shrinked. Finally, a locking device delivery catheter is used to push the locking device along the four sutures to the left atrium. The four sutures are tightened, and after the locking device locks the sutures, the sutures are cut. After the sutures are tightened and locked, the annulus is wrinkled, thereby reducing the size of the mitral valve annulus.

[0131] The above describes the valve ring shrinking device provided by the present invention in more detail by taking the shrinking of the mitral valve ring as an example. It is understandable that the valve ring shrinking device provided by the present invention is also suitable for shrinking the tricuspid valve ring. Moreover, the above is only a preferred embodiment of the present invention, and does not limit the patent scope of the present invention. All equivalent structural transformations made by using the contents of the present invention's description and drawings under the inventive concept of the present invention, or direct / indirect application in other related technical fields are included in the patent protection scope of the present invention.

Claims

1. A valve ring shrinking device, comprising a main body with a guide head at the distal end, characterized in that: The device also includes: The upper clamping arm has two clamping holes; A lower clamp arm having two first puncture channels, wherein the upper clamp arm and the lower clamp arm are rotatably connected to the main body respectively, and both have a closed state and an open state; and A suture anchoring system, comprising a puncture needle, an anchor member movable with the puncture needle, a suture and a gasket, wherein the distal end of the suture is connected to the anchor member, and the proximal end of the suture constrains the gasket; When the upper clamp arm and the lower clamp arm are in the open state, the needle outlet of the first puncture channel corresponds one-to-one with the locking hole of the upper clamp arm, the puncture needle can be ejected from the needle outlet and drive the anchor to pass through the locking hole, and pulling the suture toward the proximal end or closing the upper clamp arm can cause the anchor to be laterally clamped on the upper clamp arm.

2. The valve ring shrinking device according to claim 1, characterized in that: The back side of the main body opposite to the upper clamp arm and the lower clamp arm is provided with a suture groove extending along the axial direction of the main body, and a gasket groove communicating with the suture groove, the suture passes through the suture groove, and the gasket is located in the gasket groove.

3. The valve ring shrinking device according to claim 2, characterized in that: The main body is further provided with two blocking bars extending along the axial direction of the main body, and the two blocking bars are respectively pressed on the opposite ends of the gasket.

4. The valve ring shrinking device according to claim 1, characterized in that: The proximal end of the suture is passed through the spacer and tied at the proximal side of the spacer.

5. The valve ring shrinking device according to claim 1, characterized in that: The two free ends of the suture pass through the gasket in the same direction and are respectively connected to the anchoring members, and the U-shaped closed end of the suture constrains the gasket.

6. The valve ring shrinking device according to claim 1, characterized in that: The upper clamp arm is L-shaped, and includes two connecting parts whose proximal ends are rotatably connected to the main body, and a clamping part connected to the distal ends of the two connecting parts. The two clamping holes are arranged on the clamping part. When the upper clamp arm and the lower clamp arm are in a closed state, the lower clamp arm is embedded in a yield groove formed by the two connecting parts.

7. The valve ring shrinking device according to claim 1, characterized in that: The upper clamp arm includes a first clamp arm and a second clamp arm that is symmetrical with the first clamp arm about the main body axis, the first clamp arm and the second clamp arm both include a connecting portion whose proximal end is rotatably connected to the main body via a rotating shaft, and a clamping portion connected to the distal end of the connecting portion, the clamping portion is provided with a positioning hole, and the central axes of the two rotating shafts form an angle.

8. The valve ring shrinking device according to claim 1, characterized in that: A gasket groove is provided on the surface of the lower clamping arm facing the main body, and the gasket is placed in the gasket groove.

9. The valve ring shrinking device according to claim 8, characterized in that: The two free ends of the suture pass through the gasket in the same direction and are connected to the anchor. The U-shaped closed end of the suture constrains the gasket. When the upper clamp arm and the lower clamp arm are in the open state, the distance between the two locking holes is equal to the distance between the two holes formed by the suture in the gasket.

10. The valve ring shrinking device according to claim 9, characterized in that: The lower clamping arm also includes a wire passing channel, which passes through the gasket groove. The U-shaped closed end of the suture passes through the gasket groove and the wire passing channel in sequence from the distal end to the proximal end.

11. The valve ring shrinking device according to any one of claims 1 to 10, characterized in that: The valve ring contraction device also includes a handle, an upper clamp arm control wire connected to the upper clamp arm, and a lower clamp arm control wire connected to the lower clamp arm. The handle is used to tighten or loosen the upper clamp arm control wire and the lower clamp arm control wire so that the upper clamp arm and the lower clamp arm have the open state and the closed state relative to the main body, and to control the movement of the puncture needle.

12. The valve ring shrinking device according to claim 11, characterized in that: The main body also has a plurality of channels which all pass through its proximal end and extend along its axial direction, and the plurality of channels include two second puncture channels, an upper clamp arm control wire channel, and a lower clamp arm control wire channel.

13. The valve ring shrinking device according to claim 12, characterized in that: The valve ring contraction device also includes a multi-lumen tube whose distal end is connected to the proximal end of the main body, and the multi-lumen tube has multiple cavities extending along its axial direction. The multiple cavities include two puncture cavities, an upper clamp arm control wire cavity, a lower clamp arm control wire cavity, and a suture cavity.

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