Annuloplasty device

Abstract

The invention relates to a valve annulus plication device, which comprises a main body with a guide head at a distal end, an upper clamping arm with two clamping holes, a lower clamping arm with two first puncture channels, and a suture anchoring system. The two clamping arms are rotatably connected to the main body and each has a closed state and an open state. The suture anchoring system comprises a puncture needle, an anchor movable with the puncture needle, a suture, and a spacer. The distal end of the suture is connected to the anchor, and the proximal end of the suture restrains the spacer. In the open state of the two clamping arms, the needle outlet of the first puncture channel corresponds to the clamping hole of the upper clamping arm one by one, the puncture needle can be ejected from the needle outlet and drive the anchor to pass through the clamping hole, and proximally pulling the suture or closing the upper clamping arm can make the anchor be transversely clamped on the upper clamping arm. The valve annulus plication device is simple to operate and can significantly reduce the risk of valve annulus tearing.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a valve annulus shrinkage device. Background Technology

[0002] The mitral valve is part of the heart, located between the left atrium and the left ventricle. Blood is pumped from the left atrium into the left ventricle. When the left ventricle contracts and pumps blood throughout 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, and the posterior leaflet is opposite the anterior leaflet. Both the anterior and posterior leaflets are connected to chordae tendineae. During left ventricular contraction, the chordae tendineae restrict the upward movement of the anterior and posterior leaflets across their junction, ensuring complete closure of the mitral valve. In some patients, the mitral valve does not close properly, causing blood to be pumped into the atrium with each heartbeat, a condition known as regurgitation.

[0003] The most common way to repair damaged mitral valve function is through surgical valve replacement or repair. These surgeries require creating an opening in the patient's chest into the heart, performing extracorporeal blood circulation, fixing and suturing the mitral valve with an angioplasty ring, or replacing the mitral valve with a mechanical valve. These are highly invasive procedures. Patients with mitral regurgitation are often relatively vulnerable, thus the surgical risks are high.

[0004] Minimally invasive interventional surgery is a better option for treating most valvular heart diseases. Minimally invasive interventional surgery involves creating a small opening in the blood vessel or at the apex of the heart, through which instruments are delivered via catheter to the designated location, or the instruments are directly inserted into the designated location. The main treatment methods include artificial chordae tendineae implantation, annuloplasty, and rim-to-rim repair. Annuloplasty is primarily used to treat mitral regurgitation caused by annular dilation. Annuloplasty mainly uses minimally invasive instruments to reduce the size of the dilated mitral valve annulus, allowing the anterior and posterior leaflets to effectively engage during ventricular contraction, thus resolving the mitral regurgitation problem through annular reduction.

[0005] Circumduction includes direct and indirect annulus reduction. Indirect annulus reduction works by tightening the blood vessels surrounding the mitral valve to constrict the mitral valve annulus. Direct annulus reduction can be divided into two types: the annulus reduction achieved by directly encircling the valve annulus with an annulus ring, and partial tightening of the valve annulus to reduce the size of the mitral valve annulus and close the mitral valve leaflets tightly.

[0006] Chinese patent documents CN104000627B and CN204293210U disclose a tissue anchor and anchoring system applicable to interventional mitral valve annulus contraction surgery. Specifically, via a femoral artery approach, a radiofrequency interventional puncture wire is inserted through the mitral valve annulus into the left atrium using radiofrequency energy. A catheter with a pair of long gauze strips is then inserted along the radiofrequency interventional puncture wire through the mitral valve annulus into the left atrium. One half of the gauze is folded into a pad in the atrium, then passed through the valve annulus, and the other half is folded into a pad in the ventricle. Two tension lines are left on both gauze strips and attached to the catheter. A special locking tension line is used to achieve the desired folding effect on the mitral valve annulus, and a lock is placed to maintain the folding of the mitral valve annulus.

[0007] Surgical procedures using this tissue anchor and stabilization system are complex, requiring only one guidewire to be inserted through the valve annulus at a time, resulting in low efficiency. Furthermore, after using radiofrequency energy to puncture the valve annulus, a catheter with a gauze strip needs to be inserted through the puncture site. The catheter's large diameter leads to an enlarged puncture site on the valve annulus, increasing the risk of annular tearing. Additionally, after the gauze strip is inserted through the valve annulus, it needs to be folded at the atrium and ventricle for fixation, but the gauze inevitably gets compressed into the puncture site, further enlarging the puncture site and increasing the risk of annular tearing. Summary of the Invention

[0008] This invention provides a valve annulus retraction device to solve the technical problems of complex operation and high risk of valve annulus tearing caused by existing valve annulus retraction devices.

[0009] The present invention provides a valve annulus retraction device, comprising a main body with a guide head at its distal end, an upper clamping arm with two locking holes, a lower clamping arm, and a suture anchoring system. The lower clamping arm has two first puncture channels. The upper and lower clamping arms are rotatably connected to the main body, each having a closed state and an open state. The suture anchoring system includes a puncture needle, an anchoring element that moves with the puncture needle, a suture, and a gasket. The distal end of the suture is connected to the anchoring element, and the proximal end of the suture constrains the gasket. In the open state of the upper and lower clamping arms, the needle outlets of the first puncture channels correspond one-to-one with the locking holes of the upper clamping arm. The puncture needle can exit from the needle outlet and drive the anchoring element through the locking hole. Pulling the suture proximally or closing the upper clamping arm allows the anchoring element to be laterally locked within the upper clamping arm.

[0010] The valve annulus retraction device provided by this technical solution has a simple structure and is easy to operate. It can create two puncture sites at the location where the valve annulus needs to be retracted in one go. Using sutures instead of gauze, and because the sutures are much thinner than gauze, it can effectively reduce the diameter of the delivery catheter, that is, reduce the size of the puncture sites and avoid tearing of the valve annulus. Furthermore, using this valve annulus retraction device, two sutures can be passed through the valve annulus in one go under the guidance of the puncture needle. Locking the two sutures and pulling them together can reduce the valve annulus size, resulting in high surgical efficiency.

[0011] In one embodiment of the valve annulus retraction device provided by the present invention, the puncture needle has a cavity extending along its axial direction, and the suture anchoring system further includes a push rod. Both the push rod and the anchoring member are movably disposed within the cavity of the puncture needle. After the puncture needle is ejected and passes through the locking hole, the push rod is used to push the anchoring member out of the needle tip of the puncture needle. Thus, when the suture is pulled proximally or the upper clamping arm is closed, the anchoring member can be laterally locked onto the locking hole, serving to position the distal end of the suture on the valve annulus.

[0012] The gasket can be accommodated within the lower clamping arm or within a gasket groove on the back of the main body. The back of the main body refers to the surface opposite to the circumferential surface of the main body where the upper and lower clamping arms are mounted.

[0013] In a valve annulus shrinkage device provided in an 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 passing through the suture groove and the gasket located in the gasket groove.

[0014] In a valve annulus shrinkage device provided in one embodiment of the present invention, in order to prevent the gasket from slipping off the body, two baffles extending along the axial direction of the body are provided on the back side of the body, and the two baffles press against the opposite ends of the gasket respectively.

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

[0016] There are several ways in which the proximal end of the suture constrains the pad so that the pad can move with it. For example, in a valve annulus retraction device provided in an embodiment of the present invention, the proximal end of the suture passes through the pad and is knotted on the proximal side of the pad.

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

[0018] The upper clamping arm can be single or two. In one embodiment of the valve annulus retraction device provided by the present invention, there is only one upper clamping arm, which is generally L-shaped and includes two connecting portions rotatably connected to the main body at their proximal ends, and a clamping portion connected to the distal ends of the two connecting portions. The two clamping holes are provided in the clamping portion. When the upper and lower clamping arms are in the closed state, the lower clamping arm is embedded in the clearance groove formed by the two connecting portions. This design can reduce the volume of the lower clamping arm, thereby reducing the radial dimension of the distal end of the entire annulus retraction device, and thus reducing the size of the apical puncture site during subsequent surgery, reducing surgical risks.

[0019] In another embodiment of the present invention, the valve annulus retraction device includes two upper clamping arms, comprising a first clamping arm and a second clamping arm symmetrical about the main body axis. Both the first and second clamping arms 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 has a locking hole, and the central axes of the two rotating shafts form an included angle. This increases the distance between the locking holes of the two clamping arms when the upper clamping arms are open (this distance is essentially the distance between the two puncture sites formed on the valve annulus during subsequent surgery), thereby increasing the distance between the two puncture sites formed on the valve annulus during subsequent surgery and further avoiding the risk of valve annulus tearing due to the two puncture sites being too close together.

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

[0021] The suture routing can also be varied, depending on the placement of the gasket. In a valve annulus shrinking device provided in one embodiment of the present invention, the gasket is placed in the gasket groove of the lower clamping arm, and the lower clamping arm further includes a suture passage channel that passes through the gasket groove. The U-shaped closed end of the suture passes through the gasket groove and the suture passage channel sequentially from the distal end to the proximal end.

[0022] The opening and closing of the upper and lower clamping arms, as well as the suture anchoring system, can be controlled by a control system. In one embodiment of the present invention, the valve annulus retraction device further includes a handle, an upper clamping arm control wire connected to the upper clamping arm, and a lower clamping arm control wire connected to the lower clamping arm. The handle is used to tighten or loosen the upper and lower clamping arm control wires, thereby allowing the upper and lower clamping arms to have the open and closed states relative to the body, and to control the movement of the puncture needle and the push rod.

[0023] The routing of sutures, upper clamp control wires, and lower clamp control wires, as well as the placement of puncture needles, can be achieved by providing multiple channels in the main body. For example, in a valve annulus retraction device provided in an embodiment of the present invention, the main body also has multiple channels, each penetrating its proximal end and extending along its axial direction, the multiple channels including two second puncture channels, an upper clamp control wire channel, and a lower clamp control wire channel.

[0024] In another embodiment of the present invention, the valve annulus retraction device further includes a multi-lumen tube whose distal end is connected to the proximal end of the body. The multi-lumen tube has multiple cavities extending along its axial direction, including two puncture cavities, an upper clamping arm control wire cavity, a lower clamping arm control wire cavity, and a suture cavity.

[0025] In another embodiment of the present invention, in the valve annulus shrinkage device, along the direction from the distal end to the proximal end, the upper clamping arm control wire sequentially passes through the upper clamping arm control wire channel and the upper clamping arm control wire cavity and is then connected to the handle, the lower clamping arm control wire sequentially passes through the lower clamping arm control wire channel and the lower clamping arm control wire cavity and is then connected to the handle, and the proximal end of the suture passes through the suture cavity. Attached Figure Description

[0026] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0027] Figure 1 A schematic diagram of the structure of the valve annulus shrinkage device provided in the first embodiment of the present invention is shown.

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

[0029] Figure 3The diagram schematically illustrates the structure of the upper and lower clamping arms of the annular retraction device provided in the first embodiment of the present invention in the open state.

[0030] Figure 4 This is a schematic diagram of the main body of the valve annulus shrinkage device provided in the first embodiment of the present invention;

[0031] Figure 5 for Figure 4 The diagram shows the main body from another perspective.

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

[0033] Figure 7 A schematic diagram of the upper clamping arm of the valve annulus shrinking device provided in the first embodiment of the present invention is shown.

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

[0035] Figure 9 A schematic diagram of the structure of the lower clamping arm of the valve annulus shrinking device provided in the first embodiment of the present invention is shown.

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

[0037] Figure 11 A schematic diagram of the multi-lumen tube structure of the valve annulus shrinkage device provided in the first embodiment of the present invention is shown.

[0038] Figure 12 The diagram schematically illustrates the structure of the upper clamping arm of the valve annulus retraction device provided in the first embodiment of the present invention in the open state;

[0039] Figure 13 A schematic diagram of the upper clamping arm and its control wire of the valve annulus shrinking device provided in the first embodiment of the present invention is shown.

[0040] Figure 14 The diagram illustrates the installation of the upper clamping arm of the valve annulus shrinking device provided in the first embodiment of the present invention.

[0041] Figure 15 A schematic diagram of the puncture needle of the valve annulus retraction device provided in the first embodiment of the present invention is shown.

[0042] Figure 16 A schematic diagram of the structure of the anchoring component of the petal annulus contraction device provided in the first embodiment of the present invention is shown.

[0043] Figure 17 schematically shown Figure 16 The diagram shows the assembly of the anchor and the seam.

[0044] Figure 18 The diagram illustrates the puncture needle, suture, and anchor of the valve annulus retraction device provided in the first embodiment of the present invention facing the upper clamping arm before the needle is withdrawn.

[0045] Figure 19 The diagram illustrates the puncture needle of the valve annulus retraction device provided in the first embodiment of the present invention after needle withdrawal.

[0046] Figure 20 schematically shown Figure 19 The diagram shows the anchoring element horizontally locking onto the upper clamping arm after the puncture needle is withdrawn.

[0047] Figure 21 The diagram schematically illustrates one embodiment of the suture constraint gasket of the valve annulus shrinkage device provided in the first embodiment of the present invention;

[0048] Figure 22 A schematic diagram illustrating another embodiment of the suture constraint gasket of the valve annulus shrinkage device provided in the first embodiment of the present invention is shown.

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

[0050] Figure 24 The diagram schematically illustrates another manner in which the sutures and gaskets of the valve ring shrinking device provided in the first embodiment of the present invention are constrained by the body;

[0051] Figure 25 The diagram illustrates the puncture needle puncturing the valve annulus retraction device provided in the first embodiment of the present invention when the upper and lower clamping arms are open during surgery.

[0052] Figure 26 The diagram illustrates the anchoring element being secured to the upper clamping arm after the puncture needle is inserted during surgery using the valve annulus retraction device provided in the first embodiment of the present invention.

[0053] Figure 27 A schematic diagram of the retraction device during surgery using the valve annulus retraction device provided in the first embodiment of the present invention is shown.

[0054] Figure 28 A schematic diagram illustrating the delivery of the locking element during surgery using the valve annulus retraction device provided in the first embodiment of the present invention is shown.

[0055] Figure 29 The diagram illustrates the process of using a locking element to tighten two sutures and shrink the valve annulus during surgery using the valve annulus shrinking device provided in the first embodiment of the present invention.

[0056] Figure 30 A schematic diagram illustrating the manner in which the suture constraint gasket of the valve ring shrinkage device provided in the second embodiment of the present invention is shown.

[0057] Figure 31 A schematic diagram illustrating the sutures and gaskets of the valve ring shrinking device provided in the second embodiment of the present invention being constrained by the main body is shown.

[0058] Figure 32 The diagram illustrates the use of a locking element to tighten four sutures and shrink the valve annulus during surgery using the valve annulus shrinking device provided in the second embodiment of the present invention.

[0059] Figure 33 A schematic diagram of the main body of the valve annulus shrinkage device provided in the third embodiment of the present invention is shown.

[0060] Figure 34 A schematic diagram illustrating 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 in the third embodiment of the present invention is shown.

[0061] Figure 35 A schematic diagram of the lower clamping arm of the valve annulus shrinking device provided in the third embodiment of the present invention is shown.

[0062] Figure 36 The diagram illustrates the structure of the upper and lower clamping arms of the valve annulus shrinking device provided in the third embodiment of the present invention in the open state.

[0063] Figure 37 A schematic diagram of the upper clamping arm of the valve annulus shrinking device provided in the third embodiment of the present invention is shown.

[0064] Figure 38 A schematic diagram of the lower clamping arm of the valve annulus shrinking device provided in the third embodiment of the present invention is shown.

[0065] Figure 39 The diagram schematically illustrates the structure of the upper and lower clamping arms of the valve annulus contraction device provided in the third embodiment of the present invention in the closed state;

[0066] Figure 40 The diagram illustrates the assembled structure of the suture, gasket, and puncture needle of the valve annulus shrinkage device provided in the third embodiment of the present invention.

[0067] Figure 41The diagram illustrates the needle exiting the puncture needle when the upper and lower clamping arms are open during surgery using the valve annulus retraction device provided in the third embodiment of the present invention.

[0068] Figure 42 The diagram illustrates the anchor being engaged in the upper clamping arm during surgery using the valve annulus retraction device provided in the third embodiment of the present invention.

[0069] Figure 43 The diagram illustrates the upper clamp arm after it is closed during surgery using the valve annulus retraction device provided in the third embodiment of the present invention.

[0070] Figure 44 The diagram illustrates the retraction of the pad onto the valve annulus during surgery using the valve annulus retraction device provided in the third embodiment of the present invention.

[0071] Explanation of icon numbers:

[0072] Main body: 1, 211, 311; Multi-lumen tube: 2; Control system: 3; Upper clamp arm: 4; Lower clamp arm: 5, 350; Suture anchoring 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 face: 118; End: 12; Second puncture channel: 114; Upper clamping arm control wire channel: 115; Lower clamping arm control wire channel: 116; Suture groove: 117; Boss: 119; Gasket groove: 120, 220, 320; Puncture chamber: 21; Upper clamping arm control wire chamber: 22; Lower clamping arm control wire chamber: 24; Suture chamber: 23, 323; Distal end face: 25; Groove: 26; Handle: 31; Upper clamping arm control wire: 42; Lower clamping arm control wire: 52; Upper Clamping arm pivot: 41; Lower clamping arm pivot: 51; Connecting part: 47, 347; Clamping part: 48, 348; Positioning hole: 43, 343; Relief groove: 371, 471; Control wire fixing hole: 44; First pivot hole: 45; Upper clamping arm side near lower clamping arm: 431; Upper clamping arm side near main body: 432; First puncture channel: 53, 355; Hoist channel: 55; Lower clamping arm control wire connecting hole: 54; Second pivot hole: 5 6; Limiting groove: 311; Upper clamping arm control wire connection hole: 32; Control wire sleeve: 31; Pushing cavity: 612; Needle: 613; Thread groove: 611; Fixing hole: 621; Locking parts: 70, 170; Leaflet: 101; Leaf ring: 102, 301; Delivery guide: 71; Stop bar: 222; First clamping arm: 340; Second clamping arm: 341; Upper clamping arm connection hole: 312; Thread passage: 378; Suture passage: 317. Detailed Implementation

[0073] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are 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 positional relationship and movement of the components in a specific posture. If the specific posture changes, the directional indications will also change accordingly.

[0075] Furthermore, in this invention, descriptions involving "first," "second," etc., are for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0076] In this invention, unless otherwise explicitly specified and limited, the terms "connection," "fixed," etc., should be interpreted broadly. For example, "fixed" can mean a fixed connection, a detachable connection, or an integral part; it can mean a mechanical connection or an electrical connection; it can mean a direct connection or an indirect connection through an intermediate medium; it can mean the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0077] Furthermore, the technical solutions of the various embodiments of the present invention can be combined with each other, but only if they are feasible for those skilled in the art. If the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such combination of technical solutions does not exist and is not within the scope of protection claimed by the present invention.

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

[0079] Example 1

[0080] This embodiment provides an interventional mitral valve annulus shrinkage device for shrinking the mitral valve annulus, increasing the occlusal surface of the anterior and posterior leaflets of the mitral valve annulus, and treating mitral regurgitation.

[0081] See Figures 1 to 3 The annular 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 as shown in the figure. Figure 18 The suture anchoring system 6 shown includes a puncture needle 61, an anchor 62, a suture 63, and so on. Figure 19 The push rod 65 shown is as follows: Figure 21 The gasket 64 is shown.

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

[0083] See Figure 4 The peripheral surface 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. See also Figure 5 The main body 1 includes a proximal end face 118, and its proximal end 12 is designed with eight channels, including two second puncture channels 114, two upper clamping arm control wire channels 115, two lower clamping arm control wire channels 116, and two suture grooves 117. These eight channels extend axially along the main body and penetrate the proximal end face 118. A boss 119 is provided in the central region of the proximal end face 118 of the main body 1. The boss 119 is used for engaging 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 in the upper and lower clamping arms.

[0084] Please see also Figure 2 and Figure 6 The circumferential surface of the main body 1 without the upper and lower clamping arms installed, i.e., the back surface opposite to the mounting surface 111, is provided with two gasket grooves 120 for placing such... Figure 21 The gasket 64 is shown, along with two suture grooves 117. The proximal end of each suture groove 117 terminates in and communicates with the gasket groove 120. Each suture groove 117 is used to provide... Figure 17 and Figure 18 The stitch 63 shown provides a movement channel and accommodating space so that the stitch 63 can pass along the stitch groove 117 to the back side opposite the mounting surface 111.

[0085] Please refer to the following: Figure 1 , Figure 5 and Figure 11The distal end of the multi-lumen tube 2 is connected to the proximal end of the main body 1, and it has multiple cavities extending along its axial direction. Specifically, the multi-lumen tube 2 has two puncture cavities 21 that communicate with the second puncture channel 114 of the main body 1, two upper clamping arm control wire cavities 22 that communicate with the upper clamping arm control wire channel 115 of the main body 1, two lower clamping arm control wire cavities 24 that communicate with the lower clamping arm control wire channel 116 of the main body 1, and two suture cavities 23 that communicate with the suture groove 117 of the main body 1. The number of channels in the multi-lumen tube 2 corresponds to the number of channels in the main body 1. Thus, the second puncture channel 114 and the puncture cavities 21 cooperate to provide a accommodating space and 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 to provide a accommodating space and movement path for the puncture needle. Figure 2 The upper clamping arm control wire 42, as shown, provides accommodating space and a movement path, while the lower clamping arm control wire channel 116 and the lower clamping arm control wire cavity 24 cooperate to provide... Figure 2 The lower clamping arm control wire 52 shown provides accommodating space and movement path, and the suture groove 117 and suture cavity 23 cooperate to provide... Figure 17 and Figure 18 The suture 63 shown provides accommodating space and a path of movement. Furthermore, the central region of the distal end face 25 of the multi-lumen tube 2 is provided with a similar arrangement as shown in the image. Figure 5 The boss 119 of the main body 1 shown is fitted with a groove 26. The boss 119 is inserted into the groove 26 to achieve a snap-fit ​​connection between the proximal end of the main body 1 and the distal end of the multi-cavity tube 2.

[0086] Control system 3 includes, for example Figure 1 The handle 31 shown is as follows: Figure 2 The upper clamping arm control wire 42 and the lower clamping arm control wire 52 are shown. The handle 31 is used to tighten or loosen the upper clamping arm control wire 42 and the lower clamping arm control wire 52 to control the closing and opening of the upper clamping arm 4 and the lower clamping arm 5, and to control the movement of the puncture needle 61. In other embodiments of the invention, the handle 31 is also used to control the movement of the push rod 65 within the puncture needle 61, i.e., the push rod 65 moves forward and backward relative to the puncture needle 61.

[0087] See Figure 2 The upper clamping arm 4 is rotatably connected to the main body 1 via an upper clamping arm pivot 41, located on the circumferential surface of the main body 1 near the guide head 11. The lower clamping arm 5 is rotatably connected to the circumferential surface of the main body 1 near the multi-cavity tube 2 via a lower clamping arm pivot 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 opening angle of the upper clamping arm 4 and the lower clamping arm 5 relative to the main body 1 can be between 0° and 150°.

[0088] Please see also Figure 2 , Figure 3 , Figure 7 and Figure 8The upper clamping arm 4 is L-shaped and includes two connecting parts 47 and a clamping part 48. The proximal end of each connecting part 47 is connected to the main body 1 via an upper clamping arm pivot 41, and the distal ends of the two connecting parts 47 extend together to form the clamping part 48. The clamping part 48 has two locking holes 43 penetrating its opposite surfaces. See also... Figure 7 Two connecting portions 47 are spaced apart from each other, forming a clearance groove 471. The proximal end, not directly connected to the clamping portion 48, is provided with a control wire fixing hole 44 and a first pivot hole 45 for accommodating the upper clamping arm pivot 41. Thus, as... Figure 2 The upper clamping arm control wire 42 and the lower clamping arm control wire 52 shown can be fixed to the upper clamping arm 4 and the lower clamping arm 5 respectively. The upper clamping arm 4 and the lower clamping arm 5 can be rotated relative to the main body 1 by tightening or loosening the upper clamping arm control wire 42 and the lower clamping arm control wire 52 via the handle 31, thereby controlling the opening and closing of the two clamping arms. The clearance groove 471 makes way for the lower clamping arm 5 when the upper and lower clamping arms are closed, i.e. Figure 2 The suspended end of the lower clamping arm 5 shown is housed in the relief groove 471, which shortens the length of the main body 1, avoids the main body 1 from hitting the left atrium due to being too long during surgery, and reduces the volume of the lower clamping arm 5, thereby reducing the radial dimension of the distal end of the entire annular device, and thus reducing the size of the apical puncture site in the patient during subsequent surgery, reducing the surgical risk.

[0089] Please see also Figure 3 and Figure 8 The locking hole 43 of the upper clamping arm 4 is a tapered hole, meaning the diameter of the hole 431 on the side closer to the lower clamping arm 5 is larger than the diameter of the hole 432 on the side closer to the main body 1, to facilitate the passage of the puncture needle. The minimum diameter of the locking hole 43 is smaller than... Figure 19 The axial length of the anchor 62 shown is such that the anchor 62 can be laterally engaged with the upper clamping arm 4.

[0090] Please refer to the following: Figure 3 , Figure 9 and Figure 10 The lower clamp arm 5 is also roughly L-shaped, with two first puncture channels 53 penetrating its proximal and distal ends. The two first puncture channels 53 are roughly parallel to each other, with a diameter 0.1-0.3 mm larger than 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 clamp arm 5 is larger than the diameter at other locations, i.e., it is designed as a gourd-shaped channel 55 to ensure that the rigid tip of the puncture needle can pass smoothly.

[0091] In this embodiment, the upper clamping arm 4 and the lower clamping arm 5 are rotated relative to the main body 1 via two control wires, respectively. 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 via only one control wire. When both the upper and lower clamping arms are open, as... Figure 3As shown, the two locking holes 43 of the upper clamping arm 4 are coaxially aligned with the two needle outlet holes (actually the first puncture channel) 53 of the lower clamping arm 5, ensuring that the puncture needle can accurately reach the locking holes 43 of the upper clamping arm 4 when it is inserted.

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

[0093] Please see also Figure 2 and Figure 9 The lower clamping arm 5, connected to the main body 1, has a control wire connection hole 54 and a second rotating shaft hole 56 at its tail end. The control wire connection hole 54 is used to accommodate, for example, Figure 2 The lower clamping arm control wire 52 shown, and the second rotating shaft hole 56 are used to provide... Figure 2 The lower clamping arm pivot 51 shown provides a space to accommodate the lower clamping arm 5 and the main body 1 for rotational connection.

[0094] The upper clamping arm control wire 42 and the lower clamping arm control wire 52 can be made of the same material and are collectively referred to here as clamping arm control wires. When the clamping arm control wires are tightened by the handle 31, as Figure 12 As shown, the connecting part 47 of the upper clamping arm 4 and the lower clamping arm 5 move away from the mounting surface 111 of the main body 1, and the two clamping arms open 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 follows: Figure 3 The alignment is shown as coaxial.

[0095] The clamp control wire can be made from a single implantable metal material, such as stainless steel wire. Taking the clamp control wire 52 below as an example, it can be... Figure 13 As shown, the control wire passes through the corresponding clamping arm control wire connection hole and is welded to the lower clamping arm 5, for example, using laser welding. In other embodiments, the clamping 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, and can be easily bent when the clamping arm is closed, requiring less pushing force.

[0096] Alternatively, the clamp control wire can be made of a single strand of ultra-elastic shape memory metal material, such as nickel-titanium wire. The nickel-titanium wire is first shaped to the angle required when the clamp is closed, i.e., between 10° and 90°. When the clamp control wire is made of a different material than the corresponding clamp material, welding is not recommended; instead, limiting grooves can be created on both sides of the clamp. See clamp arm 4 above as an example. Figure 9 and Figure 14The limiting groove 311 is coaxial with the upper clamping arm control wire connection hole 32. There is also a control wire sleeve 31, also made of a super-elastic shape memory metal material, such as nickel-titanium wire. The control wire sleeve 31 is coaxial with the control wire connection hole 32, and its inner diameter is smaller than the inner diameter of the control wire connection 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 connection hole 32, but smaller than the inner diameter of the limiting groove 311. The control wire sleeve 31 is placed into the limiting groove 311, and the upper clamping arm control wire 42 is passed through the control wire connection hole 32 and enters the control wire sleeve 31. Then, the control wire sleeve 31 is welded to the upper clamping arm control wire 42. Thus, the control wire sleeve 31 is housed and fixed within 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 stored in the lower clamp arm 5, as shown in the image. Figure 9 and Figure 10 The puncture needle channel 53 shown is located within the body 1, and can be inserted along the body 1 as shown. Figure 5 The second puncture channel 114 and the multi-lumen tube 2 shown are as follows: Figure 11 The puncture chamber 21 shown enters and exits the lower clamp arm 5. The puncture needle 61 is made of a cutting process using a metal tubing material, such as stainless steel. The distal end of the puncture needle 61 is cut with a sharp needle tip 613. The puncture needle 61 also has a pushing chamber 612 and a suture groove 611 near the needle tip 613 for subsequent placement of the suture 63. The distal 3-10mm of the puncture needle 61 is a rigid section, mainly used to enhance the puncture force. The middle end of the puncture needle 61 is a flexible section with a spiral pattern to enhance its flexibility, allowing it to smoothly bend and advance when the lower clamp arm 5 is opened.

[0098] Please see also Figures 16 to 18 The anchor 62 has a tubular structure with an outer diameter slightly smaller than the inner diameter of the puncture needle 61. It is coaxially housed within the push cavity 612 of the puncture needle 61 and close to the needle tip 613. The anchor 62 has two opposing suture holes 621 radially cut in the central region of its circumference. The central axis of the suture holes 621 is perpendicular to the central axis of the push cavity 612, allowing the distal end of the suture 63 to pass through and be fixed to the anchor 62. The suture 63 emerges from the suture groove 611 near the needle tip 613. Figure 15 and Figure 18 As shown.

[0099] The anchor 62 can be made of metal materials, such as stainless steel, cobalt-chromium, or nickel-titanium. The suture 63 can be made of polypropylene (PP), polyester fiber (PET), or ultra-high molecular weight polyethylene. The suture 63 is inserted into one fixing hole 621 of the anchor 62 and exits from the other fixing hole. A ball can be formed at the end of the suture by high-temperature melting, or a knot can be tied to fix the distal end of the suture 63 to the anchor 62.

[0100] See Figure 19 The push rod 65 is movably disposed within the push cavity of the puncture needle 61. The 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 the push rod 65 can abut against the proximal end of the anchor 62, and is used to push the anchor 62 out of the puncture needle 61 after the puncture needle 61 has pierced through the valve annulus tissue and reached the locking hole 43 of the upper clamp arm 4. When the upper clamp arm 4 is closed or the suture 63 is pulled proximally, the anchor 62 will be laterally locked in the locking hole 43 of the 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 gasket 64, which is constrained by the proximal end of the suture 63, for example, see [reference needed]. Figure 21 Gasket 64 is accommodated as follows Figure 6 and Figure 23 The gasket 64 is located within the groove 120 shown. 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... Figure 5 The first puncture channel 114 of the main body 1 is shown, and it enters the back of the main body 1 as shown. Figure 6 and Figure 23 Within the suture groove 117 shown, the knotted thread end passes through the central area of ​​the gasket 64 and is accommodated in the multi-lumen tube 2. Figure 11 The suture cavity 23 shown.

[0102] In other embodiments, the proximal restraint pad 64 of the suture 63 can also be constrained by: the suture passing through the proximal end of the pad 64 using a... Figure 22 The locking sleeve 68 is used for locking. The locking sleeve 68 is made of metal, such as stainless steel. The inner diameter of the locking sleeve 68 is slightly larger than the suture 63, and the wall thickness is approximately 0.5-2 mm. Similarly, the suture end fixed by the locking sleeve 68 is accommodated in the multi-lumen tube 2, as shown. Figure 11 The suture cavity 23 is shown. When the distal end of the suture 63 is pulled by the anchor 62, the end with the fixed locking sleeve 68 will be pulled out along the suture cavity 23 of the multi-cavity tube 2 and then locked onto the gasket 64.

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

[0104] First, a apical stoma is created in the patient. The device is inserted into the left ventricle through the notch at the apex of the heart. The lower clamp control wire 52 is pulled, opening the lower clamp 5. The lower clamp 5 passes through the mitral valve chordae tendineae, supporting the mitral valve leaflet 101, and reaches the lower root of the mitral valve annulus 102. Then, the upper clamp control wire 42 is pulled, opening the upper clamp 4, clamping the leaflet 101 between the upper clamp 4 and the lower clamp 5. The puncture needle 61 is controlled to exit from the lower clamp 5, pierce the annulus 102, and pass through the locking hole 42 of the upper clamp 4. The push rod 65 inside the puncture needle 61 is pushed forward, pushing out the anchor 62. The puncture needle 61 is controlled to retract into the lower clamp 5. The puncture needle 61, carrying the suture 63, moves downwards, tightening the anchor 62. The anchor 62 then locks horizontally onto the upper clamp 4, as if... Figure 25 As shown.

[0105] Move the upper clamp arm 4 to the second position on the valve annulus 102 where it needs to be constricted. Control another set of puncture needles 61 to exit from the lower clamp arm 5, pierce the valve annulus, and then pass through the locking hole 43 of the upper clamp arm 4. Control the push rod 65 inside the puncture needle 61 to push forward, pushing 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, tightening the anchor 62, which will then be horizontally locked onto 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 towards the atrium, see [link to relevant documentation]. Figure 26 .

[0106] Retract the device toward the apex of the heart. Once close to the apex, close the lower clamp arm 5 to prevent it from clamping the valve leaflets or chordae tendineae. Figure 27 As shown. The device is then removed from the heart, and the upper clamping arm 4 pulls the suture with the anchor 62 out of the body. The two pads are then removed from the back of the main body 1 as shown. Figure 6 Remove the anchor from the accommodating groove, cut the seam at the end of the anchor, pull the seam to pull the gasket 64 under the valve ring 102, as shown. Figure 28 As shown. One end of the suture 63 with the anchor 62 remains outside the body.

[0107] Finally, using the existing locking device delivery catheter 71, the existing locking device 70 is pushed along the two sutures 63 to the left atrium, as follows. Figure 29 Tighten the two sutures 63, lock the sutures 63 with the locking device, and then cut the sutures. At this time, the valve annulus will fold 102a under the pull of the two sutures 63, thereby reducing the size of the mitral valve annulus.

[0108] The valve annulus retraction device provided in this embodiment has a simple structure and is easy to operate. It uses sutures with a diameter much smaller than those in existing technologies instead of gauze strips, reducing the diameter of the delivery catheter and resulting in a smaller puncture hole on the valve annulus, thus avoiding annulus tearing. Furthermore, using this valve annulus retraction device, two sutures can be passed through the valve annulus in one go under the guidance of a puncture needle. Locking the two sutures and pulling them together can shrink the valve annulus, resulting in high surgical efficiency.

[0109] Example 2

[0110] The annular retraction device provided in this embodiment has a similar structure to the annular retraction device provided in Embodiment 1 above. The difference lies in the method of suture restraint of the gasket and the structure on the back of the main body for accommodating the gasket. The annular retraction device provided in this embodiment shares the same structure as the annular retraction device provided in the previous embodiment, and will not be described again here.

[0111] Compared with Example 1 Figure 21 and Figure 22 The difference in structure is that the annular shrinkage device provided in this embodiment, see [reference needed] Figure 30 The two free ends of the suture 163 pass through the pad 164 in the same direction and form a U-shaped closed segment at the proximal end.

[0112] See Figure 31 The back of the main body 211 has retaining strips 222 at both ends of the pad groove 220. The pad 164 lies flat within the pad groove 220 along the axial direction of the main body 211, and the retaining strips 222 press the pad 164 down to prevent it from falling out of the groove. The two free ends of the sewing thread 163 are on the outside of the pad 164 and the main body 211, and after passing through the pad 164, they connect to... Figure 3 As shown in the lower clamping arm 5, the inner... Figure 18 The anchor 62 is located within the two puncture needles 61 shown. The U-shaped closed section of the suture 163 is located between the gasket 164 and the body 211, and is assembled to... Figure 11 The suture cavity 23 of the multi-lumen tube 2 shown.

[0113] The steps for using the valve annulus retraction device provided in this embodiment are basically the same as in Embodiment 1. The difference is that, after the lower clamp arm reaches the lower root of the mitral valve annulus, two puncture needles are simultaneously controlled to exit from the lower clamp arm, pierce the valve annulus, and pass through the locking hole of the upper clamp arm. At the same time, the push rods inside the two puncture needles are controlled to push forward, pushing 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, tightening the anchor, and the anchor will be locked horizontally on the upper clamp arm. After closing the upper clamp arm and removing the annulus retraction device from the heart, the pad is removed from the device, the suture at the end of the anchor is cut, and the suture is pulled to pull the pad under the valve annulus inside the heart, with the end of the suture with the anchor remaining outside the body.

[0114] Then, using another device identical to the annular annular retraction device provided in this embodiment, as described above, two more sutures and a spacer are implanted at another location on the annulus requiring annular retraction. Finally, the locking element 170 is pushed along the four sutures to the left atrium using the locking element delivery catheter. After tightening the four sutures and locking the sutures with the locking element 170, the sutures are cut, as described above. Figure 32 As shown.

[0115] When performing surgery using the annular constriction device provided in this embodiment, the force on the annulus can be effectively distributed because four sutures are used for mitral valve annular constriction. Furthermore, each pad uses one suture to pass through in a U-shape, turning it into two sutures, which can prevent the suture from being pulled off the pad and the pad from being pulled through the puncture hole of the annulus.

[0116] Example 3

[0117] The annular retraction device provided in this embodiment has a similar structure to the annular retraction device provided in Embodiment 2. The difference is that the annular retraction device provided in this embodiment has two upper clamping arms, two puncture needles protruding from the two sides of the lower clamping arms, and a gasket installed inside the lower clamping arms. The structural similarities between the annular retraction device provided in this embodiment and the annular retraction device provided in Embodiment 2 will not be described again 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 symmetrical about the axis of the first clamping arm 340 about the main body 311. The first clamping arm 340 and the second clamping arm 341 have the following characteristics: Figure 3 and Figure 7 The upper clamping arm 4 shown has a similar structure, generally L-shaped, including a connecting portion 347 whose proximal end is connected to the circumferential surface of the main body 311, 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 clamping arm shaft shown in the upper clamping arm connecting hole 312 ( Figure 36 (Not shown) is connected to the main body 311.

[0119] Each clamping part 348 has a locking hole 343 extending through its two opposite surfaces. See also Figure 33 , Figure 34 , Figure 36 and Figure 39 The two connecting parts 347 are spaced apart to form a clearance groove 371. The clearance groove 371 can be used to allow the lower clamping arm 350 to move when the upper and lower clamping arms are closed, i.e. Figure 39 The suspended end of the lower clamping arm 350 shown is housed in the relief groove 371.

[0120] See Figure 35 and Figure 36The middle section of the main body 311 (referring to the portion located between the proximal and distal ends of the main body 311) is provided with an upper clamping arm connecting hole 312. A pivot shaft located within one of the upper clamping arm connecting holes 312 in the main body 311 is inserted into the first clamping arm 340 and the second clamping arm 341, thereby rotatably fixing the first clamping arm 340 and the second clamping arm 341 to the main body 311, realizing the opening and closing of the upper clamping arm. It is understood that, as... Figure 36 The two upper clamping arm connecting holes 312 shown are spaced apart, and their central axes are at an angle to each other. This design allows the distance between the two locking holes 343 to be small when the two upper clamping arms are closed, and to increase when the two upper clamping arms are open. The angle between the two upper clamping arm connecting holes 312 depends on the distance between the two upper clamping arms when they are open. The main body 311 also has a sewing groove 317 for guiding the sewing thread from... Figure 33 The lower clamping arm 350 shown leads to the back of the main body 311.

[0121] Please refer to the following: Figure 33 and Figure 37 , Figure 38 The lower clamp arm 350 features a rounded distal end to prevent damage to the valve annulus when it touches the annulus. The surface of the lower clamp arm 350 facing the main body 311 has a gasket groove 320 for placing a gasket. The length of the gasket groove 320 is approximately 0.5–2 mm longer than the width of the gasket, and the width is approximately 0.5–3 mm wider than the thickness of the gasket, ensuring smooth sliding of the suture within. The depth of the gasket groove 320 is approximately 0.5–2 mm deeper than the length of the gasket. The lower clamp arm 350 also has a thread passage 378 communicating with the gasket groove 320, through which the suture can reach the main body 311. Figure 5 The suture groove 117 is shown. The lower clamping arm 350 has two first puncture channels 355 extending along its length. The overall diameter of each first puncture channel 355 is 0.1-0.3 mm larger than the puncture needle. The side of the lower clamping arm 350 that is in contact with the main body 311 when closed is the front of the lower clamping arm. Viewed from the side, the distal end of the first puncture channel 355 is biased towards the direction closer to the pad groove 320. Viewed from the front, the two first puncture channels 355 are offset at their distal ends in directions away from each other, such as... Figure 39 As shown. The two first puncture channels 355 are far apart at the distal end, which can minimize the width of the lower clamp arm 350 and allow for smoother passage through the chordae tendineae to reach the lower side of the valve annulus.

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

[0123] This design can increase the distance between the two puncture needles without increasing the distal outer diameter of the valve annulus shrinkage device provided in this embodiment. In other words, it can increase the distance between the puncture holes formed by the two sets of puncture needles on the valve annulus. This can distribute the force on the valve annulus as much as possible and avoid the force on the valve annulus being too concentrated when the suture is tightened, which would 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 clamping arm 350. The method of securing the gasket with stitch 363 can be found in [reference needed]. Figure 30 As shown, the two free ends of a suture pass through the pad from the end closest to the puncture needle, and emerge from the side of the pad closest to the main body, respectively as shown in the diagram. Figure 17 and Figure 18 As shown, after being connected to the anchor, it is assembled into a puncture needle. The U-shaped closed end of the suture enters the main body 311 along the suture channel 378 of the lower clamp arm 350. Figure 41 The suture channel 317 shown in the figure then enters as follows Figure 41 The suture cavity 323 of the multi-lumen tube shown.

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

[0126] At the apical stoma, the device is inserted into the left ventricle through the apex of the heart. Pulling the lower clamp control wire opens the lower clamp 350, which passes through the mitral chordae tendineae, supporting the mitral valve leaflet and reaching the lower root of the mitral annulus. Then, pulling the upper clamp control wire opens both upper clamps simultaneously, clamping the leaflet between the upper and lower clamps 350. Figure 41 As shown. Two puncture needles 361 are controlled to exit from the lower clamping arm 350, pierce the valve annulus 301, and then pass through the locking hole 343 of the upper clamping arm. As the two puncture needles 361 drive the sutures 363 at both ends to pierce the valve annulus 301, the sutures at both ends are folded and pass through the gasket 364. The tension on the sutures at both ends pulls the gasket 364 out of the receiving groove of the lower clamping arm 350. Then, the push rod inside the puncture needles 361 is pushed forward, pushing out the anchor 362. The puncture needles 361 are then controlled to retract into the lower clamping arm 350. The puncture needles 361, along with the sutures 363, move downwards, tightening the anchor 362. The anchor 362 then locks horizontally onto the upper clamping arm, as shown. Figure 42 As shown.

[0127] Then, push the upper clamp control wire to close the upper clamp, which pulls the two sutures 363 towards the atrium. At this time, the U-shaped closed end of the suture 363 pulls the pad 364 out along the suture channel until it is pressed tightly against the underside of the valve annulus 301. Figure 43 and Figure 44 As shown.

[0128] The spacer 364 is dislodged directly from the lower clamp arm 350 to the valve annulus 301, which can effectively prevent the spacer 364 from getting caught on the chordae tendineae during the process of being pulled from outside the heart to the valve annulus.

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

[0130] Next, using another valve annulus retraction device provided in this embodiment, and employing the same method, two more sutures and a spacer are sutured at the next location on the valve annulus to be retracted. Finally, using a locking device delivery catheter, the locking device is pushed 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 tightening and locking the sutures, the valve annulus experiences a wrinkling effect, thereby achieving the purpose of reducing the size of the mitral valve annulus.

[0131] The above description, using the mitral valve annulus contraction as an example, provides a relatively detailed explanation of the annulus contraction device provided by this invention. It is understood that the annulus contraction device provided by this invention is also applicable to the contraction of the tricuspid valve annulus. Furthermore, the above are merely preferred embodiments of this invention and do not limit the scope of the patent. Any equivalent structural transformations made based on the inventive concept of this invention and the description and drawings, or direct / indirect applications in other related technical fields, are included within the scope of patent protection of this invention.

Claims

1. A valve annular retraction device, comprising a body having a guide head at its distal end, characterized in that, The device further includes: The upper clamping arm has two locking holes; The lower clamping arm has two first puncture channels. The upper and lower clamping arms are rotatably connected to the main body, and both have a closed state and an open state. The suture anchoring system includes a puncture needle, an anchor that can move 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 gasket. When the upper clamping arm and the lower clamping arm are open, the needle outlet of the first puncture channel corresponds one-to-one with the locking hole of the upper clamping arm. The puncture needle can be ejected from the needle outlet and drive the anchor to pass through the locking hole. Pulling the suture proximally or closing the upper clamping arm can cause the anchor to be laterally locked in the upper clamping arm. The valve annulus retraction device further includes a handle, an upper clamping arm control wire connected to the upper clamping arm, and a lower clamping arm control wire connected to the lower clamping arm. The handle is used to tighten or loosen the upper clamping arm control wire and the lower clamping arm control wire, so that the upper clamping arm and the lower clamping arm have the open state and the closed state relative to the main body, and to control the movement of the puncture needle.

2. The annular shrinkage device as described in claim 1, characterized in that, The back side of the main body opposite to the upper and lower clamping arms is provided with a stitch groove extending along the axial direction of the main body and a gasket groove communicating with the stitch groove. The stitch passes through the stitch groove and the gasket is located in the gasket groove.

3. The annular shrinkage device as described in claim 2, characterized in that, The main body is also provided with two baffles extending along the axial direction of the main body, the two baffles pressing against the opposite ends of the gasket respectively.

4. The annular shrinkage device as described in claim 1, characterized in that, The proximal end of the suture passes through the pad and is knotted on the proximal side of the pad.

5. The annular shrinkage device as described in claim 1, characterized in that, The two free ends of the suture pass through the gasket in the same direction and are connected to the anchor respectively, and the U-shaped closed end of the suture constrains the gasket.

6. The annular shrinkage device as described in claim 1, characterized in that, The upper clamping 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. Two locking 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.

7. The annular shrinkage device as described in claim 1, characterized in that, The upper clamping arm includes a first clamping arm and a second clamping arm symmetrical about the axis of the main body. Both the first and second clamping arms include a connecting part whose proximal end is rotatably connected to the main body via a rotating shaft, and a clamping part connected to the distal end of the connecting part. The clamping part is provided with a locking hole, and the central axes of the two rotating shafts form an included angle.

8. The annular shrinkage device as described in claim 1, characterized in that, The lower clamping arm has a gasket groove on its surface facing the main body, and the gasket is placed in the gasket groove.

9. The annular shrinkage device as described in 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 clamping arm and the lower clamping arm are open, the distance between the two locking holes is equal to the distance between the two holes formed by the suture on the gasket.

10. The annular shrinkage device as described in claim 9, characterized in that, The lower clamping arm also includes a thread passage channel that passes through the pad groove. The U-shaped closed end of the suture passes through the pad groove and the thread passage channel sequentially from the distal end to the proximal end.

11. The annular shrinkage device as claimed in claim 1, characterized in that, The body also has multiple channels that pass through its proximal end and extend along its axial direction, including two second puncture channels, an upper clamping arm control wire channel, and a lower clamping arm control wire channel.

12. The annular shrinkage device as described in claim 11, characterized in that, The valve annulus shrinkage device further includes a multi-lumen tube whose distal end is connected to the proximal end of the main body. The multi-lumen tube has multiple cavities extending along its axial direction, including two puncture cavities, an upper clamping arm control wire cavity, a lower clamping arm control wire cavity, and a suture cavity.

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