Medical suturing device

Abstract

The application relates to the technical field of medical devices, and provides a medical suturing device, which comprises a delivery tube structure, the delivery tube structure is provided with a first through channel arranged along an axial direction of the delivery tube structure, and a first end of the delivery tube structure is provided with a receiving cavity; a fixing mechanism, the fixing mechanism comprises a fixing assembly, an anti-rotation piece and a fixing assembly control rod piece, the fixing assembly is rotatably arranged in the receiving cavity, the anti-rotation piece is rotatably arranged on the fixing assembly, the anti-rotation piece is used for fixing an artificial chordae tendinea, a rotation limiting structure for limiting the anti-rotation piece is arranged on a cavity wall of the receiving cavity, a first end of the fixing assembly control rod piece is connected with the fixing assembly, and when the fixing assembly control rod piece drives the fixing assembly to rotate around the axis of the delivery tube structure, the anti-rotation piece is limited by the rotation limiting structure and cannot rotate around the axis of the delivery tube structure; when the medical suturing device is applied to mitral valve posterior leaflet chordae tendinea implantation surgery, the artificial chordae tendinea can be prevented from being damaged, and the durability of the artificial chordae tendinea is ensured.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to a medical suture device. Background Technology

[0002] Mitral regurgitation is one of the most common valvular diseases today. The main causes include mitral annular dilatation, chordae tendineae insufficiency, mitral myxomatosis, leaflet prolapse, rheumatic valvular heart disease, and ischemic lesions. Open-heart mitral valve repair and artificial valve replacement are the most effective treatments for mitral regurgitation. However, because these surgeries require cardiopulmonary bypass, they are quite invasive and carry a high risk of complications and mortality, especially in elderly patients and those with multiple comorbidities.

[0003] Therefore, in recent years, medical and research personnel have explored transcatheter mitral valve repair techniques. The main interventional treatment methods include annulusoplasty, balloon dilation, mitral valve clipping, and artificial chordae tendineae implantation. Among these, artificial chordae tendineae implantation is considered the most promising mitral valve repair technique because it preserves the anatomical integrity of the mitral valve to the greatest extent, requires the least amount of implant, and does not affect other subsequent surgeries.

[0004] Prior art (CN 112203594 A) discloses a device for implanting artificial chordae tendineae via transseptal puncture. This device first implants a spiral rivet at the apex of the heart using a set of instruments. The spiral rivet is connected to a suture extending from the distal end to the proximal end. Then, a suture is implanted into the leaflet using another set of instruments. The principle of suture implantation is as follows: first, the spiral rivet anchors the leaflet for fixation and stability; then, a puncture needle coaxial with the rivet punctures from above the leaflet to below it, releasing the suture with a spacer. The spiral rivet is then retrieved, and the spacer and suture are implanted. The spacer is on the ventricular side, and the suture extends outward along the atrial side. Finally, a locking device fixes the two sutures on the ventricular side, and excess suture is removed.

[0005] The prior art (CN 114430674 A) discloses a chordae tendineae replacement device and method. The device comprises at least two sets of devices. One set, via an aortic route or percutaneous puncture, delivers a puncture needle with opposite magnetism to the left ventricle, then punctures the papillary muscle. A suture is embedded within the puncture needle, with a knot at its proximal end. The other set of devices, via an interatrial septum route, has a suture embedded within a magnetic puncture needle. The puncture needle punctures the valve leaflet and engages with another puncture needle to retrieve the device from the interatrial septum. The suture slides on the papillary muscle and valve leaflet. The suture on the papillary muscle side is fixed by a pre-set knot, and the suture on the valve leaflet is fixed by a re-implanted locking buckle.

[0006] The prior art (CN 112914635 A) discloses a transseptal chordae tendineae implantation device. After the valve leaflet is stabilized by a movable clamp, the device pushes the puncture needle to snap and pull back the suture pre-set in the lower clamp, forming a U-shaped suture on the valve.

[0007] A major drawback of existing artificial tendon chord implantation devices is that the rivet needs to be rotated to be inserted, and the rotation process causes the suture to twist, resulting in torsional stress on the suture and reducing its tensile strength. Summary of the Invention

[0008] The main objective of this invention is to provide a medical suture device that addresses the technical problem of stress caused by suture twisting in existing artificial tendon implantation devices.

[0009] To achieve the above objectives, the technical solution adopted by the present invention is: a medical suture device, comprising:

[0010] A conveying pipe structure having a first through channel arranged along its axial direction, and a receiving cavity at a first end of the conveying pipe structure;

[0011] The fixing mechanism includes a fixing component, an anti-rotation component, and a fixing component control rod penetrating the first through channel. The fixing component is rotatably disposed in the receiving cavity, and the anti-rotation component is rotatably mounted on the fixing component. The anti-rotation component is used to fix the artificial tendon chord. The cavity wall of the receiving cavity is provided with a rotation limiting structure that cooperates with the anti-rotation component. The first end of the fixing component control rod is connected to the fixing component. When the fixing component control rod drives the fixing component to rotate around the axis of the delivery pipe structure, the anti-rotation component is restricted by the rotation limiting structure and cannot rotate around the axis of the delivery pipe structure.

[0012] Furthermore, the fixing component includes a spiral nail, a first connector, and a second connector. The fixing component control rod includes a spiral nail drive rod and a positioning pin that passes through the spiral nail drive rod along its axis. The first connector is connected to the spiral nail, and the second connector is connected to the spiral nail drive rod. The first connector and the second connector can be connected to or separated from each other. When the first connector and the second connector are connected, the spiral nail drive rod can drive the second connector to rotate around the axis of the conveying pipe structure, thereby causing the first connector to rotate around the axis of the conveying pipe structure.

[0013] Furthermore, the first connector includes a first fastening portion, and the second connector includes a second fastening portion, wherein the first fastening portion and the second fastening portion are capable of fastening or separating from each other.

[0014] Furthermore, the outer periphery of the first connector has an annular groove, the anti-rotation component includes an annular ring and a tendon chord fixation component connected to the annular ring for fixing the artificial tendon chord, the rotation limiting structure is a limiting groove extending along the axial direction of the delivery pipe structure on the cavity wall of the receiving cavity, and the tendon chord fixation component is limited in the limiting groove.

[0015] Furthermore, the medical suture device includes a leaflet clamping mechanism, a clamping mechanism push rod, and a puncture needle. The delivery tube structure includes a clamping mechanism mounting cavity communicating with the receiving cavity. The delivery tube structure has a second through channel and a third through channel arranged along its axial direction. The leaflet clamping mechanism is hinged to the cavity wall of the clamping mechanism mounting cavity. The clamping mechanism push rod passes through the second through channel and is connected to the leaflet clamping mechanism. The puncture needle includes a puncture needle push rod passing through the third through channel and a hook portion located at the first end of the puncture needle push rod. The hook portion can extend into the leaflet clamping mechanism.

[0016] Furthermore, the delivery tube structure has a guide port that communicates with the third through channel, and the puncture needle push rod can be guided by the guide port to tilt outward toward the delivery tube structure and move toward the leaflet clamping mechanism.

[0017] Furthermore, the bottom surface of the guide port is an inclined surface, which gradually slopes outward from the second end of the conveying pipe structure toward the first end of the conveying pipe structure.

[0018] Furthermore, the hook portion is connected to the puncture needle push rod via an elastic element.

[0019] Furthermore, the leaflet clamping mechanism includes an opening and closing arm hinged to the cavity wall of the clamping mechanism mounting cavity and an elastic clamp mounted on the opening and closing arm. The first end of the clamping mechanism push rod is connected to the opening and closing arm. The second end of the opening and closing arm is further away from the delivery pipe structure than the elastic clamp. The opening and closing arm has an opening and closing arm through hole. The extension direction of the opening and closing arm through hole passes through the elastic clamp. The elastic clamp is connected to a pulling member. The delivery pipe structure has a fourth through channel arranged along its axial direction. The pulling member passes through the fourth through channel.

[0020] Furthermore, the through hole of the opening and closing arm sequentially includes a first hole, a second hole and a third hole along the direction away from the second end of the conveying pipe structure. The first hole is a trumpet hole that gradually narrows along the direction away from the second end of the conveying pipe structure. The diameter of the second hole is larger than the diameter of the third hole, and there is a step between the second hole and the third hole. The third diameter of the trumpet hole is the same as the diameter of the second hole.

[0021] Furthermore, the delivery pipe structure has a through-channel of sutures arranged along its axial direction.

[0022] Furthermore, the conveying pipe structure includes a flexible pipe and a rigid pipe head connected in sequence, with the rigid pipe head located at the first end of the conveying pipe structure.

[0023] The beneficial effects of the medical suture device provided in this application are as follows:

[0024] The medical suture device provided by this invention has an anti-rotation component for fixing the artificial chordae tendineae. When the fixing component control rod drives the fixing component to rotate around the axis of the delivery tube structure, the anti-rotation component is restricted by the rotation limiting structure and cannot rotate around the axis of the delivery tube structure. Therefore, when this medical suture device is applied to the implantation of the chordae tendineae of the posterior leaflet of the mitral valve, the artificial chordae tendineae will not be twisted and generate stress due to the implantation of the fixing mechanism, thus preventing damage to the artificial chordae tendineae and ensuring the durability of the artificial chordae tendineae.

[0025] In addition, this medical suture device requires only one implantation path, namely femoral vein puncture, which reduces trauma to the patient and facilitates postoperative recovery; the myocardial anchoring and suture leaflet are integrated into one device, avoiding the need to change instruments during the operation, saving operation time, and reducing the time the patient is exposed to radiation.

[0026] The valve opening and closing arm is equipped with an elastic clip to prevent the valve from dislodging from the arm, increasing the success rate of valve suturing. The artificial chordal connection method eliminates the need for internal suture removal after implantation, reducing intraoperative risks. The valve-myocardial fixation method prevents the artificial chordal from bypassing the valve edge, avoiding the risk of regurgitation caused by valve folding. Movable positioning pins can be used with spiral staples to prevent staple displacement or tearing during implantation. Clinically accepted e-PTFE sutures can be used to ensure long-term implantation safety. Low-cost sutures are used for the proximal end, saving on surgical costs. Attached Figure Description

[0027] To more clearly illustrate the technical solutions in the embodiments of this application, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0028] Figure 1 An exploded perspective view of a medical suture device provided for one embodiment of this application, wherein some structures are omitted;

[0029] Figure 2A partial view of a medical suture device provided for one embodiment of this application, wherein some components are omitted;

[0030] Figure 3 A cross-sectional view of a delivery conduit provided for one embodiment of this application;

[0031] Figure 4 A cross-sectional view of the conveyor pipe structure of a chain conveyor provided in one embodiment of this application;

[0032] Figure 5 A perspective view of a fixing mechanism provided for an embodiment of this application, wherein a first connector and a second connector are connected to each other;

[0033] Figure 6 for Figure 5 Enlarged view of point A in the middle;

[0034] Figure 7 A cross-sectional view of a fixing mechanism provided for one embodiment of this application;

[0035] Figure 8 Another perspective view of a fixing mechanism provided for an embodiment of this application, wherein the first connector and the second connector are disengaged from each other;

[0036] Figure 9 A partial perspective view of a medical suture device provided for one embodiment of this application;

[0037] Figure 10 A perspective view of a rivet structure in one state according to an embodiment of this application;

[0038] Figure 11 A perspective view of another state of the rivet structure provided in one embodiment of this application;

[0039] Figure 12 A mating view of a rivet structure and a positioning pin with an inner cavity provided in one embodiment of this application;

[0040] Figure 13 This is a schematic diagram of the structure of a puncture needle provided in one embodiment of this application;

[0041] Figure 14 A schematic diagram illustrating the engagement of a puncture needle and cannula according to an embodiment of this application;

[0042] Figure 15 Another schematic diagram of the fitting of the puncture needle and cannula provided for one embodiment of this application;

[0043] Figure 16A perspective view of the leaflet clamping mechanism and the clamping mechanism push rod provided in an embodiment of this application;

[0044] Figure 17 A perspective view of the relationship between the leaflet clamping mechanism and the clamping mechanism push rod and the leaflet, provided for an embodiment of this application;

[0045] Figure 18 A perspective view of an elastic clip provided for one embodiment of this application;

[0046] Figure 19 A perspective view of the elastic clip provided for other embodiments of this application;

[0047] Figure 20 A perspective view of an opening and closing arm provided for one embodiment of this application;

[0048] Figure 21 A cross-sectional view of an opening and closing arm provided for one embodiment of this application;

[0049] Figure 22 A schematic diagram illustrating the operation of some components of a medical suture device provided for one embodiment of this application;

[0050] Figure 23 A schematic diagram illustrating the operation of some components of a medical suture device provided for one embodiment of this application;

[0051] Figure 24 A schematic diagram illustrating the application of a medical suture device provided in an embodiment of this application in the first step of mitral valve posterior leaflet chordae tendineae implantation.

[0052] Figure 25 A schematic diagram illustrating the application of a medical suture device provided in an embodiment of this application in the second step of mitral valve posterior leaflet chordae tendineae implantation.

[0053] Figure 26 A schematic diagram of a medical suture device provided in one embodiment of this application being used in the third step of mitral valve posterior leaflet chordae tendineae implantation.

[0054] Figure 27 A schematic diagram of a medical suture device provided in one embodiment of this application being used in the fourth step of a mitral valve posterior leaflet chordae tendineae implantation procedure;

[0055] Figure 28 A schematic diagram of a medical suture device provided in one embodiment of this application being used in the fifth step of a mitral valve posterior leaflet chordae tendineae implantation procedure;

[0056] Figure 29 A schematic diagram of a medical suture device provided in one embodiment of this application being used in the sixth step of a mitral valve posterior leaflet chordae tendineae implantation procedure;

[0057] Figure 30 A schematic diagram of a medical suture device provided in one embodiment of this application being used in the seventh step of a mitral valve posterior leaflet chordae tendineae implantation procedure;

[0058] Figure 31 A schematic diagram of a medical suture device provided in one embodiment of this application being used in step eight of a mitral valve posterior leaflet chordae tendineae implantation procedure;

[0059] Figure 32 A schematic diagram illustrating a suture placement method provided in one embodiment of this application;

[0060] Figure 33 A schematic diagram illustrating the fixed fit between the suture and the opening / closing arm, provided for one embodiment of this application;

[0061] Figure 34 This is a schematic diagram illustrating the fixed fit between the suture and the opening / closing arm, provided for another embodiment of this application.

[0062] The details of the reference numerals used in the above figures are as follows:

[0063] 1-Artificial tendon chord; 2-Flexible cable; 3-Suture; 4-Cannula; 5-Flap; 7-Ring; 11-Stainless steel sleeve; 100-Delivery tube structure; 101-First through channel; 102-Receiving cavity; 103-Rigid tube head; 104-Delivery conduit; 105-Second through channel; 106-Third through channel; 107-Fourth through channel; 108-Suture through channel; 109-Clamping mechanism mounting cavity; 110-Limiting groove; 111-Guide port; 112-Inclined surface; 200-Fixing mechanism; 201-Anti-rotation component; 202-Fixing component control rod; 203-Spiral nail; 204-First connector; 205-The Two connecting parts; 206-Spiral nail drive rod; 207-Positioning pin; 208-Rivet structure; 209-Barbed spring; 210-Push rod; 211-First fastening part; 212-Second fastening part; 213-Annular groove; 214-Annular ring; 215-Tendon chord fixation part; 300-Flap clamping mechanism; 301-Opening and closing arm; 302-Elastic clamp; 303-Opening and closing arm through hole; 304-First hole; 305-Second hole; 306-Third hole; 308-Cable hole; 309-Slot; 400-Clamping mechanism push rod; 500-Punch needle; 501-Punch needle push rod; 502-Needle tip; 503-Barb; 504-Punch needle groove. Detailed Implementation

[0064] To make the technical problems, technical solutions, and beneficial effects to be solved by this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and are not intended to limit the scope of this application.

[0065] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on or indirectly on that other component. When a component is referred to as being "connected to" another component, it can be directly connected to or indirectly connected to that other component.

[0066] It should be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0067] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "multiple" means two or more, unless otherwise explicitly specified.

[0068] To illustrate the technical solutions described in this application, the following detailed description is provided in conjunction with specific drawings and embodiments.

[0069] See Figures 1 to 9 This invention provides a medical suture device, particularly suitable for, but not limited to, mitral valve posterior leaflet chordae tendineae implantation. The medical suture device includes:

[0070] The delivery tube structure 100 has a first through channel 101 arranged along its axial direction and a receiving cavity 102 at its first end. Specifically, the delivery tube structure 100 includes a flexible tube and a rigid tube head 103 connected in sequence. The rigid tube head 103 is located at the first end of the delivery tube structure 100. The rigid tube head 103 can be made of metal or a similar replaceable material. The flexible tube is a delivery catheter 104 with a certain degree of flexibility and a biocompatible polymer material, such as Pebax (nylon elastomer) or PA (polyamide), so that the medical suture device can conform to complex vascular pathways. The rigid tube head 103 and the delivery catheter 104 can be fixedly connected by means of fusion, welding, gluing, pin connection, etc.

[0071] The fixing mechanism 200 includes a fixing component, an anti-rotation component 201, and a fixing component control rod 202 that penetrates the first through channel 101. The fixing component is rotatably disposed in the receiving cavity 102, and the fixing component should be clearance-fitted with the receiving cavity 102 to facilitate the pushing of the fixing component. The anti-rotation component 201 is rotatably mounted on the fixing component and is used to fix the artificial tendon chord 1. The cavity wall of the receiving cavity 102 is provided with a rotation limiting structure that cooperates with the anti-rotation component 201. The first end of the fixing component control rod 202 is connected to the fixing component. When the fixing component control rod 202 drives the fixing component to rotate around the axis of the delivery pipe structure 100, the anti-rotation component 201 is restricted by the rotation limiting structure and cannot rotate around the axis of the delivery pipe structure 100.

[0072] In the medical suture device provided in this embodiment of the invention, because it has an anti-rotation component 201 for fixing the artificial chordae tendineae 1, when the fixing component control rod 202 drives the fixing component to rotate around the axis of the delivery tube structure 100, the anti-rotation component 201 is restricted by the rotation limiting structure and cannot rotate around the axis of the delivery tube structure 100. Therefore, when this medical suture device is applied to the mitral valve posterior leaflet chordae tendineae implantation surgery, the artificial chordae tendineae 1 will not be torsional and generate stress due to the implantation of the fixing mechanism 200, thus preventing damage to the artificial chordae tendineae 1 and ensuring the durability of the artificial chordae tendineae 1.

[0073] According to one embodiment of the present invention, the fixing assembly includes a spiral nail 203, a first connector 204, and a second connector 205. The fixing assembly control rod 202 includes a spiral nail drive rod 206 and a positioning pin 207 passing through the spiral nail drive rod 206 along its axis. The first connector 204 is connected to the spiral nail 203, and the second connector 205 is connected to the spiral nail drive rod 206. The first connector 204 and the second connector 205 can be connected to or separated from each other. When the first connector 204 and the second connector 205 are connected, the spiral nail drive rod 206 can drive the second connector 205 to rotate around the axis of the conveying pipe structure 100, thereby driving the first connector 204 to rotate around the axis of the conveying pipe structure 100.

[0074] In this embodiment, the spiral nail 203 is further disposed around the positioning pin 207 and is clearance-fitted with the positioning pin 207. The spiral nail 203 is clearance-fitted with the receiving cavity 102 within the receiving cavity 102. The spiral nail 203 can be cut from a tubular structure or wound from a filamentous structure, and its spiral direction is not limited to clockwise or counterclockwise. Preferably, the spiral nail 203 has a backing thread, which can prevent the spiral nail 203 from falling out of the tissue and increase the fatigue resistance of the spiral nail 203.

[0075] See Figures 10 to 12Of course, the spiral nail 203 can also be replaced by other fixing structures. For example, according to another embodiment of the present invention, the spiral nail 203 is replaced by a rivet structure 208. The rivet structure 208 is preferably made of a metal material with shape memory, such as a nickel-titanium alloy. The rivet structure 208 can be cut from a tubular structure. A barbed spring 209 is thermoplasticized in the circumferential direction. When the barbed spring 209 is subjected to circumferential force, it can shrink radially. The rivet after shrinkage is pre-installed in the positioning pin 207. The inner hole has a stepped surface, and the artificial tendon 1 can be fixed on the rivet structure 208. The positioning pin 207 is set outside the barbed spring 209. In this embodiment, the positioning pin 207 can be a tubular structure with an inner cavity. The positioning pin tip 502 is formed at the distal end by laser cutting or wire cutting. The raw material tube of the rivet structure 208 is fitted with the inner cavity of the positioning needle 207. The elasticity of the barbed spring 209, in conjunction with the inner cavity of the positioning needle 207, creates friction, preventing the rivet structure 208 from detaching from the inner cavity of the positioning needle 207. A push rod 210 is also provided within the inner cavity of the positioning needle 207, which can push the rivet structure 208 out of the inner cavity of the positioning needle 207 to release it. When a rivet needs to be implanted on the myocardial side, after pushing the device to the ventricular side, the positioning needle 207 is pushed to anchor it to the myocardium. Pushing the push rod 210 advances the rivet along the inner channel of the positioning needle 207 until it detaches from the positioning needle 207. Then, the barbed spring 209, under its own memory effect, expands into an umbrella shape and anchors itself to the myocardium.

[0076] See Figures 5 to 8 According to one embodiment of the present invention, the first connecting member 204 includes a first engaging portion 211, and the second connecting member 205 includes a second engaging portion 212. The first engaging portion 211 and the second engaging portion 212 can engage or disengage with each other. Both the first engaging portion 211 and the second engaging portion 212 can be formed as an arc-shaped concave-convex surface structure or other suitable engaging structure. The first connecting member 204 and the second connecting member 205 have through holes in their central axes. After the first connecting member 204 and the second connecting member 205 are engaged, a positioning pin 207 is inserted to engage the first connecting member 204 and the second connecting member 205. After the positioning pin 207 is retracted to a certain position, the first connecting member 204 and the second connecting member 205 are disengaged.

[0077] See Figure 6 and Figure 7According to one embodiment of the present invention, the outer periphery of the first connector 204 has an annular groove 213, the anti-rotation member 201 includes an annular ring 214 and a tendon chord fixation member 215 connected to the annular ring 214 for fixing the artificial tendon chord 1, the rotation limiting structure is a limiting groove 110 extending along the axial direction of the delivery pipe structure 100 on the cavity wall of the receiving cavity 102, the tendon chord fixation member 215 is limited in the limiting groove 110, the periphery of the tendon chord fixation member 215 may be provided with a slide, the slide cooperates with the limiting groove 110 on the rigid pipe head 103 to limit the circumferential rotation of the anti-rotation member 201, the middle part of the tendon chord fixation member 215 is a through hole, the artificial tendon chord 1 can pass through this through hole and be tied to the tendon chord fixation member 215. Of course, the limiting groove 110 can also be replaced by other limiting structures, such as limiting rails, limiting plates and other structures.

[0078] See Figures 13 to 17 According to one embodiment of the present invention, the medical suture device includes a leaflet clamping mechanism 300, a clamping mechanism push rod 400, and a puncture needle 500. The leaflet clamping mechanism 300 and the clamping mechanism push rod 400 constitute a stabilizing device for stabilizing tissue. The delivery tube structure 100 includes a clamping mechanism mounting cavity 109 communicating with the receiving cavity 102. The delivery tube structure 100 has a second through channel 105 and a third through channel 106 arranged along its axial direction. The leaflet clamping mechanism 300 is hinged to the cavity wall of the clamping mechanism mounting cavity 109, and the clamping mechanism push rod 400 passes through the second through channel. The third through channel 105 is connected to the leaflet clamping mechanism 300. The puncture needle 500 includes a puncture needle push rod 501 that passes through the third through channel 106 and a hook at the first end of the puncture needle push rod 501. The hook can extend into the leaflet clamping mechanism 300. The delivery tube structure 100 has a guide port 111 that communicates with the third through channel 106. The puncture needle push rod 501 can be guided by the guide port 111 to tilt towards the outside of the delivery tube structure 100 and move towards the leaflet clamping mechanism 300. The puncture needle 500 can be made of metal materials, such as stainless steel alloy, cobalt chromium alloy, etc. The hook portion may specifically include a needle tip 502 and a barb 503. The needle tip 502 is a sharp structure with a certain taper, used for puncturing the valve. The barb 503 is used to pull back the suture 3 pre-set in the opening and closing arm 301. The puncture needle push rod 501 may be integrally processed with the needle tip 502 or it may be processed separately and connected by welding, threaded connection or other methods. The puncture needle 500 should have a certain degree of flexibility to ensure that it can pass through the guide port 111 when the puncture needle 500 is pushed.

[0079] See Figure 14 and Figure 15According to another embodiment of the present invention, the puncture needle 500 is provided with a cannula 4, which is in clearance fit with the puncture needle 500, allowing the puncture needle 500 to extend and retract axially along the cannula 4. The cannula 4 can also move axially along the channel of the puncture needle 500. After the puncture needle 500 grasps the suture 3 on the opening and closing arm 301, it can retract into the cannula 4, sealing the puncture needle groove 504 at the barb 503, preventing the suture 3 from falling off the puncture needle 500, thereby improving the success rate of the surgery.

[0080] In a preferred embodiment of the present invention, the number of puncture needles 500 can be one. In other embodiments, two parallel puncture needles 500 can be used. Because the pressure in the left ventricle is relatively high during systole, and the mitral valve also experiences significant pressure, multiple sutures 3 are often needed to secure the artificial chordae tendineae 1 during surgical implantation to ensure its fatigue resistance. Since this embodiment uses two parallel puncture needles 500, the opening and closing arm 301 also has multiple artificial chordae tendineae 1 that cooperate with the puncture needles 500. This method allows for the implantation of multiple chordae tendineae on the valve, improving the fatigue resistance of the artificial chordae tendineae 1.

[0081] See Figure 4 According to one embodiment of the present invention, the bottom surface of the guide port 111 is an inclined surface 112. The inclined surface 112 gradually slopes outward from the second end of the delivery tube structure 100 toward the first end of the delivery tube structure 100. When the puncture needle 500 is pushed, it is guided by the inclined surface and gradually extends outward from the guide port 111 to the outside of the delivery tube structure 100.

[0082] According to one embodiment of the present invention, the hook portion is connected to the puncture needle push rod 501 by an elastic element, which may be a spring tube or a similar structure to improve the smoothness of the puncture needle 500 passing through the inclined surface 112.

[0083] See Figure 16 and Figure 17 According to one embodiment of the present invention, the leaflet clamping mechanism 300 includes an opening and closing arm 301 hinged to the cavity wall of the clamping mechanism mounting cavity 109 and an elastic clamp 302 mounted on the opening and closing arm 301. The first end of the clamping mechanism push rod 400 is specifically connected to the opening and closing arm 301 so as to drive the opening and closing arm 301 to swing. The second end of the opening and closing arm 301 is further away from the elastic clamp 302 from the delivery tube structure 100. The opening and closing arm 301 has an opening and closing arm through hole 303. The extension direction of the opening and closing arm through hole 303 passes through the elastic clamp 302. The elastic clamp 302 is connected to a pulling member (e.g., a flexible cable 2 or other alternative structure). The delivery tube structure 100 has a fourth through channel 107 arranged along its axial direction. The pulling member passes through the fourth through channel 107.

[0084] In the preferred embodiment of the present invention, the number of opening and closing arms 301 can be one. In other embodiments, two opening and closing arms 301 can be arranged circumferentially along the rigid tube head 103. Since some patients have a large mitral regurgitation area, implanting a chordae tendineae at a single location on the valve is insufficient for treating mitral regurgitation. During surgery, artificial chordae tendineae 1 are often implanted at multiple locations on the valve in the regurgitation area. Because this embodiment uses two opening and closing arms 301, the angle between the two arms 301 can be 30°~90° (but not limited to this range). Correspondingly, a corresponding puncture needle 500 is also provided on the delivery catheter 104. This method allows for the implantation of chordae tendineae at multiple locations on the valve, which can both increase the mitral valve closure area and disperse the traction force of the suture 3 on the valve, preventing valve tearing.

[0085] See Figure 2 , Figure 16 and Figure 17 In this embodiment, the clamping mechanism push rod 400 is a rod-shaped structure made of metal with a certain rigidity, which can transmit the pushing force at the proximal end (second end) to the opening and closing arm 301 at the distal end (first end). A first pin hole can be opened on the cavity wall of the mounting cavity, and a second pin hole can be opened on the opening and closing arm 301. Specifically, the opening and closing arm 301 can be hinged to the cavity wall of the clamping mechanism mounting cavity 109 by a pin passing through the first pin hole and the second pin hole. When the clamping mechanism push rod 400 is pushed, the opening and closing arm 301 can rotate (swing) around the axis of the pin. The opening and closing arm through hole 303 is used to fix the suture 3. When the puncture needle 500 is suturing, it can be pulled back through this through hole and then withdrawn.

[0086] See Figure 17 and Figure 18According to one embodiment of the present invention, the elastic clip 302 can be a structure made of a shape-memory metal alloy through a heat-setting process, such as a nickel-titanium alloy. The elastic clip 302 is generally a rod-shaped structure, such as a U-shaped rod, in which the hollow part of the U-shaped rod is precisely penetrated by the extension direction of the opening and closing arm through hole 303, avoiding obstruction of the operation of the puncture needle 500. The open end of the U-shaped rod can be fixedly connected to the body of the opening and closing arm 301 by welding, interference fit, or other means. The bottom of the U-shaped rod can be connected to a pulling element (such as a flexible cable 2). The flexible cable 2 can be a flexible stainless steel multi-strand flexible wire or a flexible polymer rope, such as PA (polyamide), PET (polyethylene terephthalate), PP (polypropylene), PTFE (polytetrafluoroethylene), etc. The flexible cable 2 is specifically movably inserted into the fourth through channel 107 and is clearance-fitted with the fourth through channel 107. When the flexible cable 2 is pulled, the elastic clip 302 forms a certain angle with the opening and closing arm 301, which facilitates the capture of the leaflet 5. When the cable tension is released, the elastic clip 302 closes with the opening and closing arm 301 under its own elasticity, thereby holding the valve leaflet and preventing the valve leaflet 5 from swinging in the blood flow and falling off the opening and closing arm 301.

[0087] See Figure 19 According to another embodiment of the present invention, the elastic clip 302 can also be processed from a sheet material using a material removal process. Compared to a rod-shaped metal spring, the sheet-shaped elastic clip 302 has a larger contact surface with the valve, that is, it obtains greater friction with the valve, further preventing the leaflet 5 from slipping off the opening and closing arm 301. The first end and proximal end of the elastic clip 302 are fixedly connected to the opening and closing arm 301, and the second end is provided with a cable hole 308 for connecting the flexible cable 2. It is also provided with a clearance through hole, and the extension direction of the opening and closing arm through hole 303 extends through the clearance through hole. The size of the clearance through hole is at least larger than the outer dimensions of the puncture needle 500, so that the puncture needle 500 can pass smoothly along the clearance through hole.

[0088] According to another embodiment of the present invention, the elastic clip 302 may also be provided with a barbed structure to prevent the leaflets 5 from falling off the opening and closing arm 301.

[0089] See Figure 20 and Figure 21According to one embodiment of the present invention, the opening / closing arm through-hole 303 sequentially includes a first hole 304, a second hole 305, and a third hole 306 along the direction away from the second end of the delivery tube structure 100. The first hole 304 is a trumpet-shaped hole that gradually narrows along the direction away from the second end of the delivery tube structure 100. The diameter of the second hole 305 is larger than the diameter of the third hole 306, and there is a step between the second hole 305 and the third hole 306. The diameter of the third hole 306 of the trumpet-shaped hole is the same as the diameter of the second hole 305. The function of the trumpet-shaped hole is that when the puncture needle 500 cooperates with the opening / closing arm through-hole 303, if there is a deviation in the alignment between the puncture needle 500 and the opening / closing arm through-hole 303, the puncture needle 500 can be corrected along the narrowing surface of the trumpet-shaped hole as it is advanced, thereby enabling normal cooperation with the opening / closing arm through-hole 303 and improving the success rate of the operation. One end of the suture 3 can be configured as a ring 7 structure, and the diameter of the third hole 306 is interference-fitted with the ring 7 of the suture 3. When the suture 3 is pre-installed, the ring 7 of the suture 3 is attached to the step between the second hole 305 and the third hole 306.

[0090] See Figure 3 In addition, the delivery pipe structure 100 has a suture passage 108 arranged along its axial direction for the passage of the suture 3. In a specific embodiment of this application, the suture passage 108, the first passage 101, the second passage 105, the third passage 106, and the fourth passage 107 all pass through the delivery conduit 104 along its axial direction and one end leads to the rigid pipe head 103.

[0091] See Figures 24 to 31 The following example, using mitral valve posterior leaflet chordae tendineae implantation, illustrates the method of using the medical suture device provided in this embodiment of the invention:

[0092] Step 1: The medical suture device is introduced through the femoral vein. The delivery tube structure 100 can advance on a moving guide wire. The first end of the delivery tube structure 100 passes through the interatrial septum, passes through the mitral valve MV, and reaches the left ventricle LV. LA refers to the left atrium.

[0093] Step 2: Push the positioning needle 207 so that it extends a certain length from the rigid tube head 103, and then push the medical suture device to fix the positioning needle 207 on the myocardium.

[0094] Step 3: Rotate and push the spiral nail 203 to fix the spiral nail 203 onto the myocardial tissue.

[0095] Step 4: Retract the positioning pin 207 to disengage the first connector 204 from the second connector 205; open the opening and closing arm 301, retract the medical suture device to stabilize the valve with the opening and closing arm 301, and then release the elastic clip 302 to fix the valve.

[0096] Step 5: Drive the puncture needle 500 through the valve;

[0097] Step 6: Withdraw the puncture needle 500, and its hook will pull back the suture 3 pre-installed in the opening and closing arm 301. At the same time, the artificial tendon chord 1 pre-loaded in the delivery catheter 104 is released.

[0098] Step 7: Close the opening and closing arm 301 and remove the medical suture device from the body;

[0099] Step 8: Fix the artificial chordae tendineae 1 to the atrium. Pull one end of the suture 3. The suture 3 can slide along the loop of the artificial chordae tendineae 1 until it is removed. The distance from the heart valve to the ventricular wall is 5cm~7cm. The length of the artificial chordae tendineae 1 is 8~10cm. The suture 3 that grows out in the atrium is only 1~5cm long and does not need to be removed.

[0100] In the above steps, if the anchoring position of the spiral nail 203 is found to be improper in the third step, the spiral nail 203 can be rotated in the opposite direction to detach it from the myocardial tissue. If the position of the opening and closing arm 301 capturing the valve leaflet 5 is improper in the fifth step, the flexible cable 2 can be stretched and the elastic clamp 302 can be opened again to repeatedly capture the valve.

[0101] Some specific embodiments regarding the installation method of the suture 3 pre-installed on the opening and closing arm 301 are as follows:

[0102] See Figure 32 A ring 7 is provided on the suture 3 pre-installed on the opening and closing arm 301. The ring 7 can be made by wrapping the suture 3 itself. The size of the ring 7 is interference-fitted with the puncture needle 500, and the two ends of the ring 7 are fixed with knots. During puncture, the distal cone of the puncture needle 500 enters the ring 7. The suture 3 is made of polymer material and has a certain degree of elasticity. It can expand radially under the action of the cone surface of the puncture needle 500 until it reaches the groove 504 of the puncture needle. The suture 3 then contracts radially to fit into the groove 504 of the puncture needle. When the puncture needle 500 is pulled back, the suture 3 can be hooked back.

[0103] In addition, the ring 7 can also be made of a metal wire with a certain degree of elasticity. A lug 8 is provided on the metal wire, and the other end is connected to the suture 3. The size of the ring 7 is an interference fit with the puncture needle 500. During puncture, under the action of the conical surface of the puncture needle 500, the lug 8 of the ring 7 can elastically expand, increasing the size of the ring 7. As the puncture needle 500 passes through the ring 7, the ring 7 contracts at the groove 504 of the puncture needle, engaging with the puncture needle 500. This method of using an elastic metal wire instead of the suture 3 coil provides better support and is less prone to deformation or detachment from the opening and closing arm 301.

[0104] In addition, the shape of the ring 7 is replaced with a spiral or folded structure, and the material is still a metal wire with a certain degree of elasticity. The advantage of this shape is that it can greatly improve the success rate of the puncture needle 500 and the ring 7, reduce the difficulty of instrument production, and improve the success rate of surgery.

[0105] Some specific embodiments of the connection between the suture 3 and the opening / closing arm 301 may be:

[0106] See Figure 20 , Figure 21 , Figure 22 and Figure 33 In one embodiment, the opening and closing arm 301 is provided with a slot 309, which extends along the direction of the opening and closing arm 301. One end of the slot 309 is connected to the through hole 303 of the opening and closing arm, and the other end extends through the opening and closing arm 301. Its width is interference-fitted with the knot of the suture 3, and its depth is tangent to the stepped surface connecting the second hole 305 and the third hole 306. Because the suture 3 has a certain elasticity, the knot of the suture 3 can be pre-installed in the slot 309 to prevent the suture from falling off. The ring 7 of the suture 3 is concentric with the through hole.

[0107] See Figure 34 In another embodiment, a stainless steel sleeve is used instead of a knot. Specifically, two strands of suture 3 are connected in series at the loop 7 of the suture 3 using a stainless steel sleeve 11. The stainless steel sleeve 11 is a tubular hollow structure. After the suture 3 passes through the stainless steel sleeve, it is fixedly connected by crimping, fusion, or welding. The axial length of the stainless steel sleeve is less than the axial length of the slot 309, and its outer diameter is an interference fit with the slot 309. When pre-installing the suture 3, the stainless steel sleeve is pre-installed in the slot 309, and the loop 7 of the suture 3 is concentric with the through hole 303 of the opening and closing arm, which can prevent the pre-installed suture 3 from falling off the opening and closing arm 301.

[0108] In another embodiment, the ring 7 is made of metal and has a certain rigidity. In addition to the above-mentioned fixing method, the ring 7 can be interference-fitted with the second hole 305. When the ring 7 is radially contracted and pre-installed in the second hole 305, the friction generated by the compression with the wall of the second hole 305 will fix it to the opening and closing arm 301.

[0109] The above description is merely an optional embodiment of this application and is not intended to limit this application. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A medical suture device, characterized in that, include: A conveying pipe structure having a first through channel arranged along its axial direction, and a receiving cavity at a first end of the conveying pipe structure; The fixing mechanism includes a fixing component, an anti-rotation component, and a fixing component control rod penetrating the first through channel. The fixing component is rotatably disposed in the receiving cavity, and the anti-rotation component is rotatably mounted on the fixing component. The anti-rotation component is used to fix the artificial tendon chord. The cavity wall of the receiving cavity is provided with a rotation limiting structure that cooperates with the anti-rotation component. The first end of the fixing component control rod is connected to the fixing component. When the fixing component control rod drives the fixing component to rotate around the axis of the delivery pipe structure, the anti-rotation component is restricted by the rotation limiting structure and cannot rotate around the axis of the delivery pipe structure.

2. The medical suture device according to claim 1, characterized in that, The fixing assembly includes a spiral nail, a first connector, and a second connector. The fixing assembly control rod includes a spiral nail drive rod and a positioning pin that passes through the spiral nail drive rod along its axis. The first connector is connected to the spiral nail, and the second connector is connected to the spiral nail drive rod. The first connector and the second connector can be connected to or separated from each other. When the first connector and the second connector are connected, the spiral nail drive rod can drive the second connector to rotate around the axis of the conveying pipe structure, thereby causing the first connector to rotate around the axis of the conveying pipe structure.

3. The medical suture device according to claim 2, characterized in that, The first connector includes a first fastening portion, and the second connector includes a second fastening portion, wherein the first fastening portion and the second fastening portion can be fastened or separated from each other.

4. The medical suture device according to claim 2, characterized in that, The outer periphery of the first connector has an annular groove. The anti-rotation component includes an annular ring and a tendon chord fixation component connected to the annular ring for fixing the artificial tendon chord. The rotation limiting structure is a limiting groove extending along the axial direction of the delivery pipe structure on the cavity wall of the receiving cavity. The tendon chord fixation component is limited in the limiting groove.

5. The medical suture device according to claim 1, characterized in that, The medical suture device includes a leaflet clamping mechanism, a clamping mechanism push rod, and a puncture needle. The delivery tube structure includes a clamping mechanism mounting cavity communicating with the receiving cavity. The delivery tube structure has a second through channel and a third through channel arranged along its axial direction. The leaflet clamping mechanism is hinged to the cavity wall of the clamping mechanism mounting cavity. The clamping mechanism push rod passes through the second through channel and is connected to the leaflet clamping mechanism. The puncture needle includes a puncture needle push rod passing through the third through channel and a hook portion located at the first end of the puncture needle push rod. The hook portion can extend into the leaflet clamping mechanism.

6. The medical suture device according to claim 5, characterized in that, The delivery tube structure has a guide port that communicates with the third through channel. The puncture needle push rod can be guided by the guide port to tilt outward toward the outside of the delivery tube structure and move toward the leaflet clamping mechanism.

7. The medical suture device according to claim 6, characterized in that, The bottom surface of the guide port is an inclined surface, which gradually slopes outward from the second end of the conveying pipe structure toward the first end of the conveying pipe structure.

8. The medical suture device according to claim 5, characterized in that, The hook is connected to the puncture needle push rod via an elastic element.

9. The medical suture device according to claim 5, characterized in that, The leaflet clamping mechanism includes an opening and closing arm hinged to the cavity wall of the clamping mechanism mounting cavity and an elastic clamp mounted on the opening and closing arm. The first end of the clamping mechanism push rod is connected to the opening and closing arm. The second end of the opening and closing arm is further away from the delivery pipe structure than the elastic clamp. The opening and closing arm has an opening and closing arm through hole. The extension direction of the opening and closing arm through hole passes through the elastic clamp. The elastic clamp is connected to a pulling member. The delivery pipe structure has a fourth through channel arranged along its axial direction. The pulling member passes through the fourth through channel.

10. The medical suture device according to claim 9, characterized in that, The opening and closing arm through hole includes a first hole, a second hole and a third hole in sequence along the direction away from the second end of the conveying pipe structure. The first hole is a trumpet hole that gradually narrows along the direction away from the second end of the conveying pipe structure. The diameter of the second hole is larger than the diameter of the third hole, and there is a step between the second hole and the third hole. The diameter of the third hole of the trumpet hole is the same as the diameter of the second hole.

11. The medical suture device according to any one of claims 1 to 10, characterized in that, The delivery pipe structure has a through-channel of sutures arranged along its axial direction.

12. The medical suture device according to any one of claims 1 to 10, characterized in that, The conveying pipe structure includes a flexible pipe and a rigid pipe head connected in sequence, with the rigid pipe head located at the first end of the conveying pipe structure.

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