Valve ring contraction device

Abstract

The invention discloses a valve ring contraction device capable of avoiding tearing of a valve ring. The valve ring contraction device comprises a main body, an upper clamping arm, a lower clamping arm and a suture anchoring system, the upper clamping arm is provided with at least one capturing rope channel and at least one through hole, each capturing rope channel penetrates through the upper clamping arm, and the far end of each capturing rope channel intersects with the at least one through hole. The near ends of the upper clamping arm and the lower clamping arm are rotatably connected with the main body. The suture anchoring system comprises a puncture needle, an anchoring part, a suture line, a gasket and a capturing rope, wherein the far end of the suture line is connected with the anchoring part, and the near end of the suture line restrains the gasket. The ferrule of the capturing rope is located in the capturing rope channel and is opposite to the through hole. When the upper clamping arm and the lower clamping arm are in an open state, a needle outlet of the puncture channel corresponds to the through hole, and the anchoring piece and the suture are matched to be capable of being ejected out of the needle outlet along with the puncture needle, penetrate through the through hole and the ferrule and then are clamped on the upper clamping arm. And the capturing rope can be pulled out from the near end of the capturing rope channel along with the capturing rope.

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 an anterior leaflet that is closer to the aorta and a posterior leaflet that is on the opposite side of the anterior leaflet. Both the anterior and posterior leaflets of the mitral valve are connected by tendinous chordae. When the left ventricle contracts, the tendinous chordae limit the upward movement of the anterior and posterior leaflets past the sealing point where the two meet, ensuring that the mitral valve closes completely. In some patients, the mitral valve does not close properly, causing blood to be pumped into the atrium every time the heart muscle contracts, which is called regurgitation.

[0003] The most common method to repair the damaged mitral valve function is to perform valve replacement or valve repair through surgery, which requires an opening to enter the heart in the patient's chest, extracorporeal blood circulation, the use of a shaping ring to fix and sew around the mitral valve, or a mechanical valve to replace the mitral valve, which is a highly invasive surgery. Patients with mitral regurgitation are often relatively fragile, so surgical operations are high-risk.

[0004] Treatment through minimally invasive interventional surgery is the better choice for most heart valve diseases. Minimally invasive interventional surgery uses a tiny opening in the human body's vascular pathways or 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 ring so that the anterior and posterior leaflets can effectively engage when the ventricle contracts, that is, to solve the problem of mitral regurgitation by ring shrinkage.

[0005] Annular contraction includes direct annular contraction and indirect annular contraction. Indirect annular contraction is to contract the mitral valve ring by tightening the vascular tissue around the mitral valve. Direct annular contraction can be divided into direct annular contraction of the valve ring by the shaping ring, and tightening of part of the valve ring to reduce the mitral valve ring and close the mitral valve leaflets tightly.

[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 access, the radiofrequency interventional puncture wire is passed through the mitral valve ring and into the left atrium in the form of 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 and into the left atrium. Half of the gauze is folded into a gasket in 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 to be attached to the catheter. A special lock is used to pull the tensioning line so that the mitral valve ring achieves the desired folding effect, and the lock is placed to keep the folding of the mitral valve ring.

[0007] The surgical operation 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 puncture hole of the annulus. The catheter has a large diameter, resulting in a larger puncture hole formed on 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 fix it, but the gauze will inevitably be squeezed into the annular puncture hole, making the annular puncture hole larger, which also leads to a high risk of annular tearing. Summary of the invention

[0008] In order to solve the technical defects of the existing valve ring shrinkage devices, such as the complicated operation and high risk of valve ring tearing, a valve ring shrinkage device provided by a technical solution of the present invention includes a main body, an upper clamp arm, a lower clamp arm and a suture anchoring system. The upper clamp arm has at least one capture rope channel and at least one through hole, each of the capture rope channels passes through the upper clamp arm and its distal end intersects with at least one through hole. The lower clamp arm has at least one puncture channel, and the upper clamp arm and the lower clamp arm are adapted so that the proximal ends are rotatably connected to the main body respectively and have a closed state and an open state. The suture anchoring system includes a puncture needle, an anchor, a suture, a gasket and a capture rope, the distal end of the suture is connected to the anchor, the proximal end of the suture constrains the gasket, and the capture rope is located in the capture rope channel and its loop is opposite to the through hole. When the upper clamp arm and the lower clamp arm are in the open state, the needle outlet of each puncture channel corresponds to a through hole in the upper clamp arm, and the anchor and the suture are adapted to be ejected from the needle outlet along with the puncture needle and clamped on the upper clamp arm after passing through the through hole and the loop, and can be pulled out from the proximal end of the capture rope channel along with the capture rope.

[0009] In the valve ring contraction device provided by a technical solution of the present invention, the upper clamp arm has a capture rope channel and two through holes separated from each other, the capture rope channel intersects with both through holes, the capture rope loop surrounds the two through holes, and the lower clamp arm has two puncture channels, each of which contains a puncture needle.

[0010] In the valve ring contraction device provided by a technical solution of the present invention, the upper clamp arm has two mutually separated capturing rope channels and two mutually separated through holes, each capturing rope channel intersects with only one through hole, a capturing rope is arranged in each capturing rope channel and the loop surrounds the through hole corresponding thereto, and the lower clamp arm has two puncture channels, each of which contains a puncture needle.

[0011] In the valve ring contraction device provided by a technical solution of the present invention, the suture anchoring system also includes at least one capture tube located in the capture rope channel, each capture rope is accommodated in the capture tube, and the loop is exposed from the distal end of the capture tube.

[0012] In the valve ring contraction device provided by a technical solution of the present invention, the through hole includes a positioning hole and a conical hole opposite to the needle outlet, the aperture of the proximal end of the conical hole is larger than the aperture of the distal end, and the distal end of the conical hole and the proximal end of the positioning hole are respectively connected to the capture rope channel.

[0013] In the valve ring contraction device provided by a technical solution of the present invention, the distal end of the suture is fixed to the middle part of the anchor, and the anchor is adapted to be laterally clamped on the upper clamp arm after passing through the through hole.

[0014] In the valve ring contraction device provided by a technical solution of the present invention, the distal end of the suture is coaxially fixed to the proximal end of the anchor, the upper clamp arm includes a rubber sheet, the rubber sheet covers the distal end of the through hole, and the anchor is adapted to pass through the rubber sheet along with the puncture needle and pass back through the rubber sheet along the original path under the traction of external force.

[0015] In the valve ring contraction device provided by one technical solution of the present invention, the anchor is made of shape memory alloy, and its distal end is adapted to recover to a natural expanded state and be stuck on the rubber sheet after passing through the rubber sheet.

[0016] In the valve ring contraction device provided by a technical solution of the present invention, the upper clamp arm has a limiting groove. When the upper clamp arm and the lower clamp arm are in a closed state, the lower clamp arm and the upper clamp arm are against the main body, and the distal end of the lower clamp arm is located in the limiting groove.

[0017] In the valve ring contraction device provided by a technical solution of the present invention, the distal end of the capture rope channel includes a capture rope placement groove, and the capture rope placement groove intersects the through hole vertically.

[0018] In the valve ring contraction device provided by a technical solution of the present invention, the upper clamp arm includes a first upper clamp arm and a second upper clamp arm symmetrical with the first upper clamp arm about the main body axis, the first upper clamp arm and the second upper clamp arm each include a connecting portion, a clamping portion, a capture rope channel and a limiting groove, the through hole is provided in the clamping portion, the proximal end of the connecting portion is rotatably connected to the main body through an upper clamp arm rotating shaft, the central axes of the two upper clamp arm rotating shafts form an angle, the clamping portion is fixed to the distal end of the connecting portion, and cooperates with the connecting portion to form an L shape, and the two limiting grooves of the upper clamp arm cooperate to form the limiting groove.

[0019] In the valve ring contraction device provided by a technical solution of the present invention, a gasket groove is provided on one side of the lower clamping arm for abutting against the main body, and the gasket is placed in the gasket groove.

[0020] In the valve ring contraction device provided by a technical solution of the present invention, the valve ring contraction device also includes a multi-lumen tube connected to the proximal end of the main body, the main body has a capture channel, the multi-lumen tube has a capture cavity communicated with the capture channel, and the end of the capture rope that is not provided with the loop passes through the capture rope channel, the capture channel and the capture cavity.

[0021] Compared with the prior art, the beneficial technical effects of the annular contraction device provided by the present invention include but are not limited to: the puncture needle can pierce the annulus and can simultaneously bring the suture and the anchor through the annulus; the puncture needle has a small diameter, and the puncture opening formed on the annulus is small, which can reduce the risk of the annulus being torn; the through hole of the upper clamp arm is connected to the capture rope channel, which constrains the suture to be pulled out from the ventricular side along the capture rope channel and the path provided by the through hole, thereby preventing the suture from tilting and sliding on the annulus and tearing the annulus. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings required for use 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 ordinary technicians in this field, other accompanying drawings can be obtained based on the structures shown in these accompanying drawings without paying any creative work.

[0023] Figure 1 The structure diagram of the valve ring shrinking device provided by the first embodiment of the present invention is schematically shown;

[0024] Figure 2The schematic diagram shows the structure of the main body and two upper clamping arms and a lower clamping arm of the valve ring shrinking device provided by the first embodiment of the present invention in a closed state;

[0025] Figure 3 The schematic diagram shows the structure of the two upper clamping arms and the lower clamping arms of the valve ring shrinking device provided by the first embodiment of the present invention in an open state;

[0026] 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;

[0027] Figure 5 for Figure 4 A schematic diagram of the relative positions of the main body and the upper clamp arm shaft connecting hole shown;

[0028] Figure 6 for Figure 4 A schematic diagram of the structure of the subject shown in another perspective;

[0029] Figure 7 The structure diagram of the first upper clamping arm and the second upper clamping arm of the valve ring shrinking device provided by the first embodiment of the present invention is schematically shown;

[0030] Figure 8 for Figure 7 A schematic structural diagram of the two upper clamping arms from another perspective;

[0031] Fig. 9 Schematically shows Figure 8 A schematic cross-sectional view of the first upper clamping arm shown;

[0032] Fig.10 for Fig. 9 A schematic cross-sectional view of a partial structure of the first upper clamping arm;

[0033] Fig.11 Schematically shows Figure 3 A schematic diagram showing the first upper clamp arm abutting against the main body in a closed state;

[0034] Fig.12 Schematically shows Figure 3 A schematic diagram showing the positional relationship between the first upper clamp arm and the yielding section of the main body when the first upper clamp arm is in an open state;

[0035] Fig.13 The schematic diagram of the structure of the lower clamping arm of the valve ring shrinking device provided by the first embodiment of the present invention is shown;

[0036] Fig.14 Schematically shows Fig.13 A schematic diagram of another perspective of the lower clamp arm shown;

[0037] Fig.15 The schematic diagram shows the structure of the puncture needle of the valve ring shrinking device provided by the first embodiment of the present invention;

[0038] Fig.16 Schematically shows Figure 2 A cross-sectional schematic diagram of the first upper clamp arm, the second upper clamp arm and the lower clamp arm in an open state;

[0039] Fig.17 The schematic diagram of the structure of the distal end of the multi-lumen tube of the valve ring shrinking device provided by the first embodiment of the present invention is schematically shown;

[0040] Fig.18 A schematic diagram showing the suture anchoring system of the valve ring annulus contraction device provided by the first embodiment of the present invention relative to the first upper clamping arm is shown;

[0041] Fig.19 A schematic diagram showing the puncture needle of the valve ring shrinking device provided by the first embodiment of the present invention passing through the first upper clamping arm after being removed from the puncture needle;

[0042] Fig. 20 Schematically shows Fig.19 A schematic diagram showing that the puncture needle retreats after being removed and the anchor is laterally clamped in the first upper clamp arm;

[0043] Fig.21 The diagram schematically shows the assembly of the valve ring annulus contraction device provided by the first embodiment of the present invention with the gasket and the puncture needle after the suture passes through the first suture channel of the main body;

[0044] Fig. 22 A schematic diagram of a valve ring clamping device provided by a first embodiment of the present invention is schematically shown;

[0045] Fig.23 A schematic diagram showing the puncture needle of the valve ring shrinking device provided by the first embodiment of the present invention being withdrawn to the lower clamping arm after being removed and the gasket being pulled out of the lower clamping arm;

[0046] Fig.24 A schematic diagram showing a proximal end of a suture of a valve ring shrinking device provided by the first embodiment of the present invention being pulled out of the body and a gasket being closely attached to the lower part of the valve ring;

[0047] Fig.25 The schematic diagram shows the suture of the valve ring shrinking device provided by the first embodiment of the present invention being separated from the lower clamping arm and being attached to the lower side of the valve ring with the gasket;

[0048] Fig.26 A schematic diagram showing the suture of the valve ring annulus contraction device provided by the first embodiment of the present invention being withdrawn from the body and returned to the body;

[0049] Fig. 27 The schematic diagram shows the delivery of the locking element along the suture when performing a valve ring reduction surgery using the valve ring reduction device provided by the first embodiment of the present invention;

[0050] Fig.28 A schematic diagram showing a method of using a locking member to lock sutures to achieve contraction of the valve ring when performing surgery using the valve ring contraction device provided by the first embodiment of the present invention;

[0051] Fig.29a The figure schematically shows the assembly diagram of the upper clamping arm and the capture rope in the deformed structure of the valve ring shrinking device provided by the first embodiment of the present invention;

[0052] Fig.29 The schematic diagram of the assembly of the capture tube and the capture rope of the valve ring shrinking device provided by the second embodiment of the present invention is shown schematically;

[0053] Fig.30 A schematic diagram showing a valve ring shrinking device provided by the second embodiment of the present invention in which the puncture needle of the valve ring shrinking device is withdrawn to the lower clamping arm after being removed and the gasket is pulled out of the lower clamping arm by the suture and the capture rope;

[0054] Fig.31 A schematic diagram showing the anchoring member of the valve ring shrinking device provided by the second embodiment of the present invention being separated from the rubber sheet under the pulling of the capture rope;

[0055] Fig.32 A schematic diagram showing a valve ring contraction device according to a second embodiment of the present invention in which the suture is pulled out of the body and the gasket is closely attached to the lower part of the valve ring;

[0056] Fig.33 The structure diagram of the anchor and the suture in the deformed structure of the valve ring contraction device provided by the second embodiment of the present invention when not constrained by the puncture needle is schematically shown;

[0057] Fig.34 The schematic diagram of the structure of the anchor and the suture in the puncture needle in the deformed structure of the valve ring shrinking device provided by the second embodiment of the present invention is shown;

[0058] Fig.35 Schematically shows Fig.34 The schematic diagram of the structure of the anchoring member after being pushed out of the puncture needle;

[0059] Fig.36 The schematic diagram of the structure of the upper clamping arm of the valve ring shrinking device provided by the third embodiment of the present invention is shown;

[0060] Fig.37 The schematic diagram of the assembly of the upper clamping arm and the capture rope of the valve ring shrinking device provided by the third embodiment of the present invention is schematically shown;

[0061] Fig.38 Schematic diagram showing the structure of the lower clamp arm of the valve ring shrinking device provided by the third embodiment of the present invention

[0062] Fig.39 A schematic diagram of an upper clamping arm and a lower clamping arm of a valve ring shrinking device provided by a third embodiment of the present invention in an open state is shown schematically;

[0063] Fig.40 The diagram schematically shows the upper clamping arm and the lower clamping arm of the valve ring shrinking device provided by the third embodiment of the present invention in a closed state.

[0064] Description of Figure Numbers:

[0065] Mitral valve annulation device: 100; control system: 3; main body: 1; multi-lumen tube: 2; first upper clamp arm: 340; second upper clamp arm: 341; lower clamp arm: 5, 250; suture anchoring system: 6; handle: 31; upper clamp arm control wire: 42; lower clamp arm control wire: 51; lower clamp arm rotating shaft: 52; puncture needle: 61; push rod: 65; guide head: 11; yielding section: 14; installation section: 15; connection section: 12; upper clamp arm yielding groove: 111; Upper clamp arm shaft hole: 112; upper clamp arm connecting groove: 13; upper clamp arm positioning surface: 150; tapered hole: 43; capture channel: 120; first suture channel: 117; proximal end surface: 118; lower clamp arm connecting hole: 113; lower clamp arm positioning surface: 17; lower clamp arm connecting hole: 113; puncture channel: 114; upper clamp arm control wire channel: 115; lower clamp arm control wire channel: 116; boss: 119; connecting part: 47; clamping part: 50; First shaft hole: 45; limiting groove: 471; first control wire connection hole: 44; capture rope channel: 472; capture rope placement groove: 473; proximal end of tapered hole: 431; distal end of tapered hole: 432; positioning hole: 501; anchor: 62, 164; second control wire connection hole: 54; second shaft hole: 56; puncture needle channel: 55; needle outlet: 551; gasket groove: 320; second suture channel: 378; suture: 63, 1 63; fixed end: 631; puncture cavity: 21; upper clamp arm control wire cavity: 22; lower clamp arm control wire cavity: 24; suture cavity: 23; capture rope cavity: 28; groove: 26; capture rope: 60, 150; needle: 613; push cavity: 612; wire groove: 611; ring: 601, 1501; mitral valve ring: 101; delivery catheter: 71; locking piece: 70; capture tube: 151; rubber sheet: 280; upper clamp arm: 440. DETAILED DESCRIPTION

[0066] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0067] It should be noted that all directional indications in the embodiments of the present invention are only used to explain the relative position relationship, movement status, etc. between various components in a certain specific posture. If the specific posture changes, the directional indication will also change accordingly.

[0068] In addition, in the present invention, descriptions such as "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of the present invention, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0069] In the present invention, unless otherwise clearly specified and limited, the terms "connection", "fixation", etc. should be understood in a broad sense. For example, "fixation" can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0070] 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 the field can implement it. When the combination of technical solutions is contradictory or cannot be implemented, it should be deemed that such combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0071] It should be noted that "distal" and "proximal" are used as directional terms, which are commonly used terms in the field of medical devices, where "distal" refers to the end away from the operator during surgery, and "proximal" refers to the end close to the operator during surgery. Axial refers to the direction parallel to the line connecting the distal center and the proximal center of the medical device; radial refers to the direction perpendicular to the above axial direction.

[0072] The valve ring shrinking device provided by the present invention includes a main body, an upper clamp arm, a lower clamp arm and a suture anchoring system. The upper clamp arm has at least one capture rope channel and at least one through hole. The capture rope channel passes through the upper clamp arm and its distal end is connected to at least one through hole. Each through hole is used to provide a puncture path for the puncture needle and suture. The puncture needle in the suture anchoring system has a small diameter and is not easy to tear the valve ring during puncture; the capture rope can pull the suture out from the ventricle side along the capture rope channel on the atrial side, which can prevent the suture from tilting and sliding on the valve ring and tearing the valve ring.

[0073] The present invention can provide a variety of valve ring shrinking devices suitable for different application scenarios. For application scenarios where the valve ring needs to be sutured and shrunk multiple times, it is often required that the distal end of the device entering the heart has a smaller radial dimension and can leave two puncture holes with a large distance on the valve ring to avoid the two puncture holes being too close and merging into one due to stress concentration, thereby tearing the valve ring. Therefore, the suitable shrinking device provided by the present invention may have two upper clamping arms, each of which is provided with a through hole, and the lower clamping arm accommodates two puncture needles. The distance between the puncture holes left by the puncture needle on the valve ring is increased by increasing the distance between the two through holes after the two upper clamping arms are opened. Each upper clamping arm may be provided with a capture rope channel, and a capture rope is placed in each capture rope channel, and the loop of the capture rope is opposite to one of the through holes.

[0074] For application scenarios where only a small number of sutures are performed, such as two times, the valve ring shrinking device provided by the present invention may include only one upper clamping arm. The upper clamping arm may include a capture rope channel and two through holes separated from each other, the capture rope channel intersects with both through holes, a capture rope is placed in the capture rope channel and the capture rope loop surrounds the two through holes, and two puncture needles are placed in the lower clamping arm. In this way, a capture rope can be used to pull the sutures passing through the two through holes out of the body along the capture channel, saving surgical time. . Alternatively, the valve ring shrinking device provided by the present invention includes only an upper clamping arm having only one through hole, the upper clamping arm has a capture rope channel, and the lower clamping arm only accommodates one puncture needle.

[0075] The valve ring shrinking device provided by the present invention is described in detail below by taking a valve ring shrinking device with two upper clamping arms as an example.

[0076] The first embodiment of the present invention provides a mitral valve annulus shrinking device 100 for treating mitral valve regurgitation by shrinking the mitral valve annulus and increasing the coaptation surface between the anterior leaflet and the posterior leaflet of the mitral valve annulus.

[0077] See also Figures 1 to 3 The valve ring contraction device 100 includes a control system 3, a main body 1, a multi-lumen tube 2, a first upper clamp arm 340, a second upper clamp arm 341, a lower clamp arm 5, and two Fig.18 A suture anchor system 6 is shown.

[0078] 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 51 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 51 to control the closing and opening of the first upper clamp arm 340, the second upper clamp arm 341 and the lower clamp arm 5, and to control the movement of the puncture needle 61 and the movement of the puncture push rod 65 relative to the puncture needle 61.

[0079] See also Figure 2 The distal end of the main body 1 has a smooth guide head 11 with a conical arc surface, which mainly plays a guiding role to facilitate entering the left ventricle from the apex during surgery, and from the left ventricle through the valve to the left atrium.

[0080] See also Figure 4 The main body 1 includes a clearance section 14, a mounting section 15 and a connecting section 12 in order from the distal end to the proximal end. The clearance section 14 has an upper clamp arm clearance groove 111 extending in the axial direction. The first upper clamp arm 340 and the second upper clamp arm 341 are as shown in FIG. Figure 2 In the closed state shown, the first upper clamping arm 340 and the second upper clamping arm 341 are located in the upper clamping arm yielding groove 111 and abut against the yielding section 14 .

[0081] The distal end of the mounting section 15 is provided with a plurality of holes on both sides of the upper clamp arm clearance groove 111. Figure 5 The upper clamp arm shaft hole 112 shown in FIG. Figure 4 The upper clamp arm connecting groove 13 is shown. The distal end of the mounting section 15 protrudes from the clearance section 14, and its distal end surface forms an upper clamp arm positioning surface 150. The proximal end of the first upper clamp arm 340 and the proximal end of the second upper clamp arm 341 are respectively located in an upper clamp arm connecting groove 13, and the upper clamp arm shaft ( Figure 4 Not shown, see Figure 2 ) is rotatably fixed on the mounting section 15.

[0082] like Figure 5 As shown, the two upper clamp arm shaft holes 112 are separated from each other, and the central axes form an angle, that is, the central axes of the two upper clamp arm shafts 41 connecting the two upper clamp arms to the main body 1 form an angle. The degree of the angle formed by the central axes of the two upper clamp arm connecting holes 112 can be determined according to the distance required after the two upper clamp arms are opened, that is, the distance of the puncture holes required to be formed on the mitral valve ring of the patient. In this way, Figure 3 In the open state shown in FIG. 1 , the distance between the locking holes 501 of the two upper clamping arms is greater than that between the two upper clamping arms. Figure 2In the closed state shown, the distance between the two becomes larger, and together with the needle outlet 551 of the lower clamp arm 5, they are located on the needle outlet movement path of the puncture needle of the suture anchoring system 6, thereby increasing the distance between the puncture holes formed by the two puncture needles on the valve ring, avoiding the two puncture holes being too close to each other and merging into a larger puncture hole, thereby causing valve ring tearing, and reducing the radial size of the distal end of the device. Correspondingly, the size of the stoma at the patient's apex is smaller, thereby reducing the patient's pain.

[0083] Continue to see Figure 4 The main body 1 is also provided with two capture channels 120 and a first suture channel 117. Each capture channel 120 passes through the distal end face of the mounting section 15 and the proximal end face of the connecting section 12. The proximal end face of the connecting section 12 is the proximal end face 118 of the main body 1. The first suture channel 117 starts from the middle of the mounting section 15 and passes through the proximal end face of the connecting section 12, i.e., the proximal end face 118 of the main body 1, and is used to pass the suture 63 as shown in FIG. Fig.21 As shown, the main body 1 is led out and connected to the puncture needle 61.

[0084] The distal end of the connecting section 12 is provided with a lower clamp arm connecting hole 113, and has a distal end surface protruding from the proximal end of the mounting section 15, and the distal end surface constitutes a lower clamp arm positioning surface 17. The lower clamp arm 5 is connected to the lower clamp arm through the lower clamp arm connecting hole 113. Figure 4 Not shown, see Figure 2 ) is rotatably connected to the connecting section 12.

[0085] See also Figure 4 and Figure 6 The connecting section 12 is provided with 9 channels, including two puncture channels 114, two upper clamp arm control wire channels 115, two lower clamp arm control wire channels 116, a first suture channel 117, and two capture channels 120. The 9 channels extend along the axial direction of the main body and all pass through the proximal end surface 118. The connecting section 12 is provided with a boss 119 for connecting with the multi-lumen tube 2 in the central area of ​​the proximal end surface 118. The boss 119 can be connected with the multi-lumen tube 2 by snapping, or can be connected to each other through a rotating shaft.

[0086] See also Figure 2 and Figure 3The first upper clamp arm 340 and the second upper clamp arm 341 are arranged in mirror symmetry with respect to the main body 1, and both are L-shaped as a whole, and the structures of the two are the same. The two upper clamp arms can be closed and opened by rotating one end relative to the main body 1, and the angle of opening relative to the main body 1 can be between 0° and 150°. When the first upper clamp arm 340, the second upper clamp arm 341 and the lower clamp arm 5 are opened, the suspended ends of the two upper clamp arms and the suspended end of the lower clamp arm 5 will rotate in a direction close to each other. When the two upper clamp arms and the lower clamp arm 5 are in the open state, the suspended ends of the two upper clamp arms are opposite to the suspended end of the lower clamp arm 5. The structure of the first upper clamp arm 340 is described in detail below, and the structure of the second upper clamp arm 340 is not repeated.

[0087] The first upper clamp arm 340 is generally L-shaped and includes: Figure 3 and Figure 7 The connecting portion 47 shown in the figure and the clamping portion 50 fixed to the distal end surface of the connecting portion 47 and forming an angle with the distal end of the connecting portion 47. The first upper clamping arm 340 has the following Fig. 9 A capture line passage 472 is shown extending through its distal and proximal ends.

[0088] See also Figure 7 The proximal end of the connecting portion 47 is provided with Figure 5 The upper clamp arm shaft hole 112 shown in the figure matches the first shaft hole 45. The connecting portion 47 is inserted into the upper clamp arm shaft hole 112 and the first shaft hole 45 as shown in the figure. Figure 2 The upper clamp arm shaft 41 is rotatably connected to the main body 1. The connecting portion 47 is provided with a limiting groove 471 at its proximal end. Figure 2 In the closed state shown, the first upper clamp arm 340 and the second upper clamp arm 341 are pressed against each other, and the suspended end of the lower clamp arm 5 is located in the limiting groove formed by the limiting grooves 471 of the two upper clamp arms. This shortens the axial 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 clamp arm 5, thereby reducing the radial size of the distal end of the valve ring shrinking device 100, thereby reducing the size of the apical puncture in the patient during subsequent surgery, reducing the surgical risk. The proximal end of the connecting portion 47 is provided with a Figure 2 The upper clamp arm control wire 42 is connected to the first control wire connecting hole 44 shown.

[0089] See also Figure 2 , Fig.11 and Fig.12 The distal end of the upper clamp arm control wire 42 is fixed in the first control wire connection hole 44 of the first upper clamp arm 340. Fig.11In the closed state shown, the upper clamp arm control wire 42 can be pulled toward the proximal end by the handle 31 to control the rotation of the first upper clamp arm 340 relative to the connecting section 14 of the main body 1. Fig.12 When the first upper clamp arm 340 abuts against the upper clamp arm positioning surface 150 of the mounting section 15, the first upper clamp arm 340 rotates to the limit angle, and the first upper clamp arm 340 is in the open state. When the upper clamp arm control wire 42 is loosened toward the distal end, the first upper clamp arm 340 rotates toward the direction close to the main body 1 until it is opened again as shown in FIG. Fig.11 shown resting against the body 1. Fig. 9 The connecting portion 47 is also provided with a capture rope channel 472 that runs through its proximal end and distal end, for accommodating the capture rope and providing a movement path.

[0090] See also Fig. 9 , the capture rope channel 472 passes through the connecting portion 47 and the clamping portion 50. The distal section of the capture rope channel 472 located in the clamping portion 50 is the capture rope placement groove 473. The clamping portion 50 has a through hole 508 that passes through its two opposite surfaces and intersects with the distal end of the capture rope channel 472, namely the capture rope placement groove 473. In this way, it can be ensured that after the puncture needle completes puncturing the valve ring through the through hole 508, the suture can be pulled out from the ventricle side along the capture rope channel 472 along the capture rope channel 472, thereby preventing the suture from sliding obliquely on the valve ring and tearing the valve ring. Preferably, the capture rope placement groove 473 intersects with the through hole 508 at a right angle, which is equivalent to constraining the suture to be pulled out in a direction perpendicular to the valve ring, further preventing the suture from sliding along the valve ring.

[0091] The through hole 508 includes a conical hole 43 and a locking hole 501 coaxial with the conical hole 43. The distal end of the conical hole 43 and the proximal end of the locking hole 501 are respectively connected to the capture rope placement groove 473. The conical hole 43 plays a guiding role. The aperture of the proximal end 431 is larger than the aperture of the distal end 432 to facilitate the passage of the puncture needle. The projection of the capture rope placement groove 473 formed in the radial direction of the conical hole 43 is located outside the conical hole 43, so that after the capture rope 60 is installed, the ferrule at the distal end of the capture rope 60 can be Fig.10 The aperture of the positioning hole 501 is smaller than the minimum aperture of the tapered hole 43 and smaller than Fig. 20 The axial length of the anchor member 62 shown is to facilitate the anchor member 62 to be laterally clamped on the first upper clamp arm 340.

[0092] Please also read Figures 13 to 15 The lower clamp arm 5 is roughly L-shaped, with a smooth distal end to prevent damage to the valve ring when it is pushed under the valve ring, and a second control wire connecting hole 54 and a second shaft hole 56 are provided at its proximal end. Figure 2 The distal end of the lower clamp arm control wire 51 is fixed in the second control wire connection hole 54, as shown in FIG. Figure 2The lower clamp arm shaft 52 shown passes through the second shaft hole 56 , whereby the lower clamp arm 5 is rotatably connected to the main body 1 via the lower clamp arm shaft 52 and rotates relative to the main body 1 under the control of the lower clamp arm control wire 51 to achieve opening and closing of the lower clamp arm 5 .

[0093] The lower clamp arm 5 has two Fig.15 and Fig.16 The puncture needle channel 55 shown. Each puncture needle channel 55 passes through the lower clamp arm 5, and the overall diameter is 0.1-0.3mm larger than the diameter of the puncture needle, and is used to accommodate the puncture needle. Fig.15 As shown, the diameter of the puncture needle channel 55 at the distal end bend of the lower clamp arm 5 is larger than the diameter at other locations, that is, it is designed as a gourd-shaped channel to ensure that the rigid front end of the puncture needle can pass smoothly.

[0094] like Fig.16 As shown, the two puncture needle channels 55 are substantially parallel to each other and are offset in a direction away from each other at the distal end. The needle outlets 551 of the two puncture needle channels 55 are respectively located on two opposite sides of the lower clamp arm 5. Figure 2 The surface that abuts against the main body 1 in the closed state shown is the abutment surface, and the side surface here refers to the two surfaces of the lower clamp arm 5 that are respectively connected to the abutment surface and connect the proximal end and the distal end of the lower clamp arm 5. Since the first upper clamp arm 340 and the second upper clamp arm 341 are opened when the valve ring shrinking device 100 is working, the positioning holes 501 of the two are separated by a certain distance, and each needle outlet 551 of the lower clamp arm 5 needs to be coaxially opposite to a positioning hole 501 of the upper clamp arm. Therefore, this design can reduce the width of the lower clamp arm 5, which can not only pass through the tendons to reach the lower side of the valve ring more smoothly, but also reduce the radial size of the distal end of the device 100.

[0095] Continue reading Fig.14 and Fig.15 The lower clamp arm 5 is provided with a portion for placing a Fig.18 The spacer groove 320 of the spacer 64 shown in the figure, and the second suture channel 378. The spacer groove 320 is larger than the size of the spacer 64 to ensure that Fig.18 The suture 63 connected to the gasket 64 can slide smoothly in the gasket groove 320. The second suture channel 378 is connected to the gasket groove 320, so that the suture 63 can reach the main body 1. Figure 4 A first suture channel 117 is shown.

[0096] like Fig.16As shown, when the first upper clamp arm 340 and the second upper clamp arm 341 are in the open state, the distance between the two upper clamp arms becomes larger. When the lower clamp arm 5 is opened, the needle outlets 551 of the two puncture needle channels 55 therein are aligned one by one with the tapered holes 43 of the first upper clamp arm 340 and the second upper clamp arm 341, and are located on the movement path of the puncture needle, so that after the puncture needle comes out of the puncture needle channel 55 of the lower clamp arm 5, it can pass through the valve ring and then pass through the tapered holes 43 of each upper clamp arm. In this way, the needle outlet distance of the two puncture needles can be increased without increasing the distal outer diameter of the valve ring shrinking device 100, and the distance between the puncture holes formed by the two puncture needles on the valve ring can be increased, thereby dispersing the force on the valve ring and avoiding excessive concentration of the force on the valve ring when the suture is locked, which causes the two puncture holes to tear and merge into one large hole.

[0097] Please also read Figure 1 and Fig.17 The distal end of the multi-lumen tube 2 is connected to the proximal end of the main body 1, and corresponds to the main body 1, and has 9 cavities that penetrate along its axial direction. Figure 6 and Fig.17 The multi-lumen tube 2 is provided with two puncture cavities 21 respectively communicating with the puncture channel 114 of the main body 1, two upper clamp arm control wire cavities 22 respectively communicating with the upper clamp arm control wire channels 115 of the main body 1, two lower clamp arm control wire cavities 24 respectively communicating with the lower clamp arm control wire channels 116 of the main body 1, a suture cavity 23 communicating with the first suture channel 117 of the main body 1, and two capture rope cavities 28 respectively communicating with the capture channel 120 of the main body 1. In this way, the puncture channel 114 and the puncture cavity 21 cooperate with each other to provide a accommodating space and a conveying path for the puncture needle, and the upper clamp arm control wire channel 115 and the upper clamp arm control wire cavity 22 cooperate with each other to provide a puncture needle. Figure 2 The upper clamp arm control wire 42 shown provides a receiving space and a delivery 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 Figure 2 The lower clamp arm control wire 51 shown provides a receiving space and a delivery path, and the first suture channel 117 and the suture cavity 23 cooperate with each other to provide Fig.18 The suture 63 shown in the figure provides a space for accommodating and a delivery path. In addition, the multi-lumen tube 2 is provided with a central area of ​​its distal end face 25 as shown in the figure. Figure 6 The boss 119 of the main body 1 is shown to match the groove 26. The boss 119 is inserted into the groove 26 to achieve the connection between the main body 1 and the multi-lumen tube 2.

[0098] See also Fig.18 Each suture anchoring system 6 includes a puncture needle 61, an anchor 62, Fig.19 Push rod 65, spacer 64, suture 63 and capture rope 60 are shown.

[0099] The puncture needle 61 can be movably received in the lower clamp arm 5. Fig.16 The puncture needle 61 can be inserted into and withdrawn from the lower clamp arm 5 along the puncture channel 114 of the main body 1 and the puncture cavity 21 of the multi-lumen tube 2. The distal end of the puncture needle 61 has a sharp needle 613. The puncture needle 61 has a push cavity 612, and a thread groove 611 is provided near the needle 613 to make way for the suture 63. The 3-10 mm distal end of the puncture needle 61 is a rigid section, which mainly plays a role in enhancing 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 turn and move forward smoothly in the lower clamp arm 5 when the needle needs to be removed.

[0100] The anchor 62 is a tubular structure, the outer diameter of which is slightly smaller than the inner diameter of the puncture needle 61, and is coaxially received in the pushing cavity 612 of the puncture needle 61 and close to the needle head 613. Fig.19 , the diameter of the anchor 62 is smaller than the diameter of the positioning hole 501. Fig. 20 As shown, the length of the anchor 62 is greater than the aperture of the positioning hole 501. The anchor 62 can be made of metal materials, such as stainless steel, cobalt-chromium, nickel-titanium, etc., or a polymer sleeve, which can be connected to the suture 63 by crimping or bonding. The suture 63 can be made of polypropylene, polyester fiber or ultra-high molecular weight polyethylene.

[0101] See also Fig.19 The push rod 65 is movably disposed in the pushing cavity 612 of the puncture needle 61. 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 passes through the valve ring tissue and the positioning hole 501 of the clamping part 50. When the upper clamp arm is closed or the suture 63 is pulled toward the proximal end, the anchor 62 will Fig. 20 As shown, it is laterally clamped on the clamping hole 501 of the clamping portion 50 .

[0102] The gasket 64 is received in the lower clamp arm 5. Fig.14 and Fig.15 The gasket 64 is made of implantable polymer materials, such as nylon, polyester fiber, etc., which have good biocompatibility with human tissue.

[0103] Continue to see Fig.18 The two fixed ends 631 of the suture 63 pass through the gasket 64 in the same direction and are fixed to the middle part of an anchor 62 respectively, and are led out from the thread groove 611 of the puncture needle 61. As a result, the proximal end of the suture forms a U-shaped closed end, which enters the first suture channel 117 (such as the first suture channel 117 of the main body 1) along the second suture channel 378 of the lower clamp arm 5. Fig.21 As shown), then enter Fig.17 The suture lumen 23 of the multi-lumen tube 2 is shown.

[0104] See also Fig.18 , the distal end of the capture rope 60 has a loop 601. In the assembled state, the distal end of the capture rope 60 is mounted on each upper clamp arm such as Fig. 9 and Fig.10 The capture rope is shown placed in the groove 473, and the ring 601 surrounds the tapered hole 43 of the upper clamp arm. The diameter of the ring 601 is larger than the small end diameter of the tapered hole 43, so that the puncture needle 61 can pass through the ring 601. Fig. 22 As shown, the capture rope 60 can enter the capture channel (not shown) of the main body 1 and the capture rope cavity 28 of the multi-lumen tube 2 in sequence through the capture rope channel 472 of the upper clamp arm, and extend out of the body. The capture rope 60 can be a metal wire, such as nickel-titanium wire, stainless steel wire, etc., or a polymer wire, such as polypropylene wire, polyester wire, etc., which has a high tensile strength, is not easy to be broken, and has good flexibility to adapt to the bending of the device delivery path.

[0105] Taking the reduction of the mitral valve annulus as an example, the steps of performing surgery using the annulus reduction device 100 provided in this embodiment are described in detail below.

[0106] First, the patient's apical stoma is made, and the distal end of the device 100 is inserted into the left ventricle from the notch on the apex of the heart. The lower clamp arm control wire 51 is pulled to open the lower clamp arm 5. The lower clamp arm 5 passes through the mitral valve chordae tendineae and supports the mitral valve leaflets. The distal end of the lower clamp arm 5 reaches the lower root of the mitral valve ring 101. Then, the upper clamp arm control wire 42 is pulled to open the two upper clamp arms at the same time. Fig. 22 As shown, the leaflet is clamped by the first upper clamp arm 340 and the second upper clamp arm 341 ( Fig. 22 (not shown) and the lower clamping arm 5.

[0107] The two puncture needles 61 are controlled to be ejected from the lower clamp arm 5 at the same time. After piercing the valve ring 101, the puncture needles 61 sequentially pass through the tapered hole 42 of the upper clamp arm, the loop 601 of the capture rope 60, and the positioning hole 501. It can be understood that when the two puncture needles 61 drive the suture 63 to pierce the valve ring 101, the suture 63 is stressed, and the gasket 64 is pulled out of the gasket placement groove 320 of the lower clamp arm 5.

[0108] The push rod 65 in the puncture needle 61 is controlled to push the anchor 62 out of the puncture needle 61 toward the distal end. The puncture needle 61 is controlled to retract into the lower clamp arm 5, and the puncture needle 61 will move downward with the suture 63 to tighten the anchor 62, and the anchor 62 will be as Fig.23 As shown, it is laid horizontally and clamped on the clamping portion 50 of the upper clamping arm.

[0109] When the two capture ropes 60 are pulled outside the body, the capture ropes 60 will hook the suture 63 and move outside the body. One end of the suture 63 is clamped on the clamping part 50 through the anchor 62, and the other end slides outside the body along the capture rope channel of the device under the pull of the loop of the capture rope 60 until the suture 63 is separated from the lower clamp arm 5 and is closely attached to the lower part of the valve ring 101 with the gasket 64. Fig.24 shown.

[0110] Remove the capture rope 60 from the body, close the two upper clamp arms, and withdraw the distal end of the body 1 toward the apex of the heart. The suture 63 will return to the device 100 along the suture lumen 23 of the multi-lumen tube 2. Fig.25 As shown. When the main body 1 is withdrawn close to the apex, the lower clamp arm 5 is closed to prevent the lower clamp arm 5 from clamping the valve leaflets or chordae tendineae. After the distal end of the main body 1 is completely withdrawn from the heart, the suture 63 also follows the first suture channel 117 of the main body from the upper clamp arm ( Fig.25 Only the first upper clamp arm 340 is shown. Fig.26 shown.

[0111] The suture 63 at the end of the anchor 62 is cut off outside the heart, and the anchor 62 is recovered. After the suture 63 passes through the valve ring 101, the suture 63 is first pulled out of the body along the capture channel 120 of the upper clamp arm to ensure that the suture 63 slides in a direction perpendicular to the valve ring 101, thereby preventing the suture 63 from sliding on the valve ring 101 in a tilted direction relative to the valve ring 101, causing the valve ring 101 to tear at the puncture position.

[0112] Another set of valve ring shrinking device 100 is used and two more sutures and a gasket 64a are sewn at the position where the valve ring 101 is to be shrunk in the same way. The locking mechanism delivery catheter 71 is used to push the locking member 70 along the four sutures 63 to the left atrium, such as Fig. 27 The four sutures 63 are tightened and locked with the locking member 70, so that the valve ring 101 produces a wrinkled effect, thereby shrinking the mitral valve ring, as shown in FIG. Fig.28 shown.

[0113] The annular contraction device 100 provided in this embodiment includes the following advantages: two groups of puncture needles can pass through the annulus via the through holes on the upper clamp arm, and can directly pass sutures with a diameter much smaller than that of the gauze strip in the prior art through the annulus, and has a capture rope channel intersecting with the through holes, which can form two very small puncture holes and two groups of sutures on the annulus at one time, avoiding tearing of the annulus, saving time for the contraction operation, and reducing the pain of the patient; and the through holes and the capture rope channel of the upper clamp arm constrain the puncture needles to complete the puncture, and the sutures can only be pulled out from the ventricle side along the path provided by the capture rope channel and the through holes with the capture rope, further avoiding the sutures from tilting and sliding on the annulus and tearing the annulus.

[0114] It should be noted that in a modified structure of the valve ring contraction device 100 provided in this embodiment, the capture rope 60 is selectively accommodated in the capture rope channel 472 of the first upper clamping arm 340 or the second upper clamping arm 341, and its ring 601 is accommodated in the capture rope placement groove 473 and surrounds the tapered hole 43 of the first upper clamping arm 340 and the second upper clamping arm 341, such as Fig.29a As shown. With this arrangement, one capture rope 60 can be used to simultaneously carry two groups of sutures 63 ejected from two puncture needles 61 along the capture rope channel 472 along the capture rope 60. Fig.23 Pulling it out from the ventricle side as shown simplifies the surgical operation and improves the surgical efficiency.

[0115] The valve ring shrinking device provided in the second embodiment of the present invention has a similar structure to the valve ring shrinking device 100 provided in the first embodiment, and the differences include: Fig.29 As shown, each suture anchoring system includes a capture tube 151 in addition to a capture rope 150; and Fig.30 As shown, the anchor 164 is in the form of a sleeve, coaxially sleeved on one end of the suture 163 and fixedly connected to the distal end of the suture 163, rather than Fig.19 and Fig. 20 The middle portion of the anchor 62 is shown connected to the suture 63, and the anchor 62 can be as shown. Fig. 20 As shown, it can be clamped horizontally on the clamping part 50; and, the clamping hole 501 of the clamping part 50 is closed by the rubber sheet 280. The rubber sheet 280 can be made of silicone or other soft rubber to reduce the resistance of the puncture needle passing through. The rubber sheet 280 can also be pre-provided with a through hole (not shown) that is coaxially connected to the clamping hole 501 of the clamping part 50 to further reduce the resistance of the subsequent pulling back of the suture 163. Except for the capture rope and anchoring member, other components and structures of the valve ring contraction device of this embodiment that are not mentioned here can refer to the relevant text description and drawings of Example 1, and will not be repeated here.

[0116] The capture rope 150 is pre-installed in the capture tube 151 and can slide in the capture tube 151 under the pulling of external force, and its ring 1501 is located outside the far end of the capture tube 151.

[0117] The capture tube 151 has high flexibility to adapt to the curvature of the device delivery path, and can be a flexible polymer tube or a flexible cut metal tube, such as a stainless steel tube or a nickel titanium tube with a spiral pattern, or a spring tube wound with a metal wire. The capture tube 151 can be positioned on the upper clamp arm by other components such as Fig. 9 The capture rope passage 472 is shown in the figure, and its distal end face is close to the end of the capture rope passage 472 that communicates with the capture rope placement groove 473.

[0118] After the puncture needle 61 pierces the valve ring 101 and passes through the ring 1501, the positioning hole 501 of the clamping part 50 and the rubber sheet 280, the anchor 164 and the suture 163 are pushed out of the puncture needle 61, and the puncture needle 61 is retracted into the lower clamp arm 5, leaving only the anchor 164 and the suture 163 passing through the ring 1501 of the capture rope 150 and the rubber sheet 280. Since the rubber sheet 280 has a certain squeezing force on the suture 163, and the suture passing through the rubber sheet 280 has a certain length, if Fig.30 As shown, the distal end of the suture 163 does not retreat with the puncture needle 61.

[0119] Understandably, please also refer to Fig.30 and Fig.31 Since the capture tube 151 remains stationary in the first upper clamp arm 340, the ferrule 1501 is pulled toward the proximal end toward the distal end of the capture tube 151. Fig.31 As shown, the anchor 164 will pass over the rubber sheet 280, the ring 1501 will cooperate with the distal end of the capture tube 151, clamping the suture 163 at the distal end of the capture tube 151, and the gasket 64 will be pulled out from the second clamp arm 5 and move toward the direction close to the valve ring 101 driven by the suture 163.

[0120] The capture rope 150 and the capture tube 151 are simultaneously withdrawn from the body, and the suture 163 and the anchor 164 are pulled out of the body together. It is understandable that the suture 163 and the gasket 64 are closely attached to the lower side of the valve ring 101. Fig.32 As shown. The suture 163 is cut outside the body. Then the device is withdrawn from the body. As the device is withdrawn, the single suture 163 will return to the device along the multi-lumen tube, the main body and the suture channel of the lower clamp arm, and finally from the upper clamp arm. Fig. 9 The capture line passage 472 is shown emerging therefrom.

[0121] Another set of instruments and the same method are used to sew another two sutures and a gasket at the position where the valve ring 101 is to be shrunk. Finally, the locking mechanism is implanted to shrink the valve ring 101 using the same method as in the first embodiment.

[0122] Compared with the first embodiment, the valve ring contraction device of this embodiment uses the capture tube 151 to cooperate with the capture rope 150 to clamp the distal end of the suture 163 and pull the suture 163 out of the body. The suture 161 will not slide in the ring 1501, and only a single suture 163 moves in the capture rope channel, avoiding the mutual friction of the two sutures, reducing the friction force on the suture 163, thereby reducing the resistance of the capture rope 150, and only a small pulling force is needed to pull the capture rope out of the body, avoiding the breakage of the capture rope 150 and the suture 163 or generating large wear. In addition, compared with the two sutures in the first embodiment being pulled out of the body at the same time, the length of the required suture is also greatly reduced, avoiding material waste.

[0123] In order to further reduce the risk of the suture following the puncture needle and exiting the loop of the capture rope, in a deformation structure of the valve ring contraction device provided in this embodiment, the anchor 164 can be made of a shape memory alloy tube commonly used in the art, and in the naturally expanded state, the radial dimension of its distal end is larger than the diameter of the locking hole of the upper clamp arm, or it is adapted to restore the natural expanded state after passing through the rubber sheet and be locked at the distal end of the rubber sheet.

[0124] For example, the anchor 164 can be cut and shaped from a nickel titanium tube. Fig.33 When the anchor member 164 is as shown in FIG. Fig.18 When the anchor 164 is assembled in the puncture needle 61 as shown, it can be understood that the anchor 164 is constrained by the puncture needle 61 into a straight shape, and when the anchor 164 is pushed out of the puncture needle 61, the anchor 164 will restore its deformation in the natural state, that is, restore to a hook shape. When the puncture needle 61 passes through the rubber sheet 280 and retreats to the lower clamp arm 5 as described above, the anchor 164 is no longer constrained by the puncture needle 61 and restores to a hook shape, so that it can be stuck on the rubber sheet 280 and does not separate from the rubber sheet 280 as the puncture needle 61 retreats. When the capture rope 150 hooks the suture 163 and clamps the suture 163 together with the distal end of the capture tube 151, under a large pulling force, the anchor 164 will be pulled into a straight line shape and pass over the rubber sheet 280 and enter the capture tube 151 in the upper clamp arm 340 together with the suture 163, and then withdrawn from the body together.

[0125] In another variant structure of the valve ring shrinking device provided in this embodiment, the anchor 164 is also made of a shape memory alloy tube commonly used in the art, and its distal end not connected to the suture 163 is cut and shaped into a petal shape. Fig.34 As shown, the distal end of the anchor 164 is cut into two pieces along the axial direction. When assembled in the puncture needle 61, the anchor 164 will be constrained as shown in FIG. Fig.35 The anchor 164 is in the straight line shape shown. When the anchor 164 is pushed out of the puncture needle 61, the anchor 164 recovers its deformation to the petal shape in the natural state. Therefore, when the puncture needle 61 is completely removed and retracted to the lower clamp arm 5, the anchor 164 will recover its natural state due to the loss of the constraint of the puncture needle 61. Since its distal radial dimension is larger than the aperture of the puncture hole formed by the puncture needle on the rubber sheet 280, or the aperture of the clamping hole of the upper clamp arm, the anchor 164 will be stuck on the rubber sheet 280. When the capture rope 150 hooks the suture 163 and clamps the suture 163 together with the distal end of the capture tube 151, under a large pulling force, the anchor 164 will also be pulled into a straight line shape and pass through the rubber sheet 280 and enter the capture tube 151 in the upper clamp arm 340, and be withdrawn from the body together. In order to clamp the anchor 164 on the rubber sheet 280 more stably, the distal end of the anchor 164 can also be cut into multiple pieces along the axial direction.

[0126] The valve ring shrinking device provided in the third embodiment of the present invention has a structure similar to the valve ring shrinking device 100 provided in the first embodiment, and the differences include: there is only one upper clamping arm 440, and the structure of the lower clamping arm 250 is different from the structure of the lower clamping arm 5. The valve ring shrinking device of this embodiment, except for the upper clamping arm 440 and the lower clamping arm 250, has other components and structures not mentioned here, which can be referred to the relevant text description and drawings of the first embodiment, and will not be repeated here.

[0127] The upper clamp arm 440 may be Figure 2 As shown, the upper clamp arm is rotatably connected to the main body 1 through two upper clamp arm shafts 41 and an upper clamp arm control wire 42. The structure can be as follows: Figure 7 The first upper clamp arm 340 and the second upper clamp arm 341 are formed integrally along the mirror symmetry axis, but the size is reduced. Fig.36 As shown, the clamping portion 50 of the upper clamping arm 440 has only one Fig. 9 The through hole 508 shown in FIG. Fig.39 and Fig.40 The capture rope passage 472 is shown. The far end of the capture rope passage 472 is a capture rope placement slot 473. The through hole 508 intersects with the capture rope placement slot 473. Fig.37 As shown, the capture rope 60 is accommodated in the capture rope channel 472, and its loop 601 is located in the capture rope placement groove 473 and surrounds the through hole 580.

[0128] The structure of the lower clamp arm 250 is substantially the same as that of the lower clamp arm 5 in the first embodiment, except that Figures 38 to 40 , which has only one puncture needle channel 55, and the puncture needle channel 55 passes through the central area of ​​the distal end of the lower clamp arm 250. Fig.38 and Fig.39 The lower clamp arm 250 is provided with a portion for placing a Fig.18 The gasket 64 is shown with the gasket groove 320 and the second suture channel 378 .

[0129] In the open state of the upper clamp arm 440 and the lower clamp arm 250, see Fig.39 , the needle outlet of the puncture needle channel 55 is opposite to the tapered hole 43 of the upper clamp arm 440. When the upper clamp arm 440 and the lower clamp arm 250 are in the closed state, as shown in FIG. Fig.40 As shown, the distal end of the lower clamping arm 250 is received in the limiting groove 471 of the upper clamping arm 440 .

[0130] In addition, the main body 1 needs to reduce the number of control wire channels of the upper clamp arm accordingly, and the multi-lumen tube 2 needs to reduce the number of control wire lumens of the upper clamp arm accordingly.

[0131] The valve ring contraction device provided in this embodiment can be applied to application scenarios that require two suture contraction rings. Since there is only one upper clamping arm, the radial dimension of its distal end is smaller. Correspondingly, the stoma that needs to be formed at the apex of the heart is smaller, which can reduce the patient's pain and reduce the risk of surgery.

[0132] The above uses the contraction of the mitral valve ring as an example to explain the valve ring contraction device provided by the present invention in more detail. It can be understood that the valve ring contraction device provided by the present invention is also suitable for contracting 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 changes made by using the contents of the present invention specification 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, It is characterized in that include: main body; An upper clamp arm having at least one capture rope channel and at least one through hole, each capture rope channel passing through the upper clamp arm and having a distal end intersecting with at least one through hole; The lower clamp arm has at least one puncture channel, and the upper clamp arm and the lower clamp arm are adapted so that the proximal ends are rotatably connected to the main body respectively and have a closed state and an open state; and A suture anchoring system, comprising a puncture needle, an anchor, a suture, a gasket and a capture rope, wherein the distal end of the suture is connected to the anchor, the proximal end of the suture constrains the gasket, and the capture rope is located in the capture rope channel and its loop is opposite to the through hole; When the upper clamp arm and the lower clamp arm are in the open state, the needle outlet of each puncture channel corresponds to a through hole, and the anchor and the suture are adapted to be ejected from the needle outlet along with the puncture needle and clamped on the upper clamp arm after passing through the through hole and the loop, and can be pulled out from the proximal end of the capture rope channel along with the capture rope.

2. The valve ring shrinking device according to claim 1, It is characterized in that The upper clamp arm has a capture rope channel and two through holes separated from each other, the capture rope channel intersects with both through holes, the capture rope loop surrounds the two through holes, and the lower clamp arm has two puncture channels, each of which contains a puncture needle.

3. The valve ring shrinking device according to claim 1, It is characterized in that The upper clamp arm has two mutually separated capture rope channels and two mutually separated through holes, each capture rope channel intersects with only one through hole, a capture rope is arranged in each capture rope channel and the ferrule surrounds the corresponding through hole, and the lower clamp arm has two puncture channels, each of which contains a puncture needle.

4. The valve ring shrinking device according to any one of claims 1 to 3, It is characterized in that The suture anchoring system further comprises at least one capture tube located in the capture line channel, each capture line is accommodated in one capture tube, and the loop emerges from the distal end of the capture tube.

5. The valve ring shrinking device according to claim 4, It is characterized in that The through hole includes a locking hole and a conical hole opposite to the needle outlet, the aperture of the proximal end of the conical hole is larger than the aperture of the distal end, and the distal end of the conical hole and the proximal end of the locking hole are respectively communicated with the capture rope channel.

6. The valve ring shrinking device according to claim 4, It is characterized in that The distal end of the suture is fixed to the middle part of the anchor, and the anchor is adapted to be laterally clamped on the upper clamp arm after passing through the through hole.

7. The valve ring shrinking device according to claim 4, It is characterized in that The distal end of the suture is coaxially fixed to the proximal end of the anchor, the upper clamp arm includes a rubber sheet, the rubber sheet covers the distal end of the through hole, and the anchor is adapted to pass through the rubber sheet along with the puncture needle and pass back through the rubber sheet along the original path under the traction of external force.

8. The valve ring shrinking device according to claim 7, It is characterized in that The anchor is made of shape memory alloy, and the distal end of the anchor is adapted to restore a natural unfolding state after passing through the rubber sheet and be stuck at the distal end of the rubber sheet.

9. The valve ring shrinking device according to claim 1, It is characterized in that The upper clamp arm has a limiting groove. When the upper clamp arm and the lower clamp arm are in a closed state, the lower clamp arm and the upper clamp arm abut against the main body, and the distal end of the lower clamp arm is located in the limiting groove.

10. The valve ring shrinking device according to any one of claims 1 to 3, It is characterized in that The distal end of the capture rope channel comprises a capture rope placement slot, and the capture rope placement slot intersects the through hole perpendicularly.

11. The valve ring shrinking device according to claim 9, It is characterized in that The upper clamp arm includes a first upper clamp arm and a second upper clamp arm that is mirror-symmetrical to the first upper clamp arm with respect to the main body, the first upper clamp arm and the second upper clamp arm each include a connecting portion, a clamping portion, a catching rope channel and a limiting groove, the clamping portion has a through hole, the proximal end of the connecting portion is rotatably connected to the main body through an upper clamp arm rotating shaft, the central axes of the two upper clamp arm rotating shafts form an angle, the clamping portion is fixed to the distal end of the connecting portion, and cooperates with the connecting portion to form an L shape, and the two limiting grooves of the upper clamp arm cooperate to form the limiting groove.

12. The valve ring shrinking device according to claim 1, It is characterized in that The valve ring contraction device also includes a multi-lumen tube connected to the proximal end of the main body, the main body has a capture channel, the multi-lumen tube has a capture cavity communicated with the capture channel, and the end of the capture rope without the loop passes through the capture rope channel, the capture channel and the capture cavity.

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