Valve Suturing Device

Abstract

The present application provides a valve suture device, which includes a pushing device and a clamping device. The pushing device includes a pushing catheter. The clamping device includes a clamping push rod, a proximal chuck, a distal chuck, a clamping operating mechanism and an elastic mechanism. The clamping push rod is movably inserted into the pushing catheter. The proximal chuck is arranged at the distal end of the pushing catheter, and the distal chuck is arranged at the distal end of the clamping push rod. The elastic mechanism is fixedly connected to the proximal end of the clamping push rod, and the clamping operating mechanism is movably connected to the proximal end of the clamping push rod and the elastic mechanism. After the clamping operating mechanism drives the clamping push rod to move from the distal end to the proximal end to close the distal chuck and the proximal chuck, the clamping operating mechanism compresses the elastic mechanism, causing the clamping operating mechanism to displace proximally relative to the clamping push rod to give a sound feedback, thereby preventing the operator from forcibly moving the clamping operating mechanism proximally to obtain the sound feedback, so that the distal chuck and the proximal chuck overly clamp the valve leaflet and injure the valve leaflet.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and particularly to a valve suture device. Background Art

[0002] The mitral valve is a one-way "valve" between the left atrium (abbreviation: LA) and the left ventricle (abbreviation: LV), which can ensure that blood flows from the left atrium to the left ventricle. Please refer to Figure 1 , a normal and healthy mitral valve has multiple chordae tendineae. The valve leaflets of the mitral valve are divided into the anterior leaflet and the posterior leaflet. When the left ventricle is in a diastolic state, both are in an open state, and blood flows from the left atrium to the left ventricle; when the left ventricle is in a systolic state, the chordae tendineae are stretched to ensure that the valve leaflets will not be washed into the atrial side by the blood flow, and the anterior and posterior leaflets are closed well, so as to ensure that blood flows from the left ventricle through the aortic valve (abbreviation: AV) to the aorta. If the chordae tendineae or papillary muscles are diseased, for example Figure 2 as shown in the rupture of the posterior chordae tendineae, when the left ventricle is in a systolic state, the mitral valve cannot return to the closed state as in the normal state, and the impact of the blood flow will further cause the valve leaflets to prolapse into the left atrium, resulting in blood reflux.

[0003] Currently, surgical implantation of sutures is usually used to treat chordae tendineae diseases, which requires invasive thoracotomy technology and general anesthesia and moderate hypothermic cardiopulmonary bypass as auxiliary support. Such surgical operations have defects such as complex surgical procedures, high surgical costs, high patient trauma, high risk of complications, long hospital stays, and painful patient recovery processes.

[0004] There is a current instrument for implanting sutures in a minimally invasive manner. This instrument implants sutures by clamping the valve leaflets with a clamping device. The clamping device includes a clamping push rod, a distal clamp head and a proximal clamp head for cooperating to clamp the valve leaflets, and a clamping operation mechanism connected to the proximal end of the clamping push rod. The clamping operation mechanism moves from the distal end to the proximal end to close the distal clamp head and the proximal clamp head. When the clamping operation mechanism moves from the distal end to the proximal end to a predetermined position, a closing sound feedback is emitted. The operator can confirm whether the distal clamp head and the proximal clamp head are closed according to the sound feedback. However, due to the inevitable tolerance problem in the manufacturing process, the length of the clamping push rod may be insufficient, resulting in the situation that when the distal clamp head and the proximal clamp head clamp the valve leaflets and close, the clamping operation mechanism cannot move to the predetermined position to emit the sound feedback. And in order for the operator to confirm the closing of the distal clamp head and the proximal clamp head, if the clamping operation mechanism is forced to move proximally, it will cause the distal clamp head and the proximal clamp head to over-clamp the valve leaflets and damage the valve leaflets. Summary of the Invention

[0005] In order to avoid the problem of the distal clamp head and the proximal clamp head over-clamping the valve leaflets and damaging the valve leaflets, the present application provides a valve suture device.

[0006] In order to achieve the above object, the embodiments of the present application adopt the following technical solutions:

[0007] The present application provides a valve suture device, which includes a pushing device and a clamping device. The pushing device includes a pushing catheter; the clamping device includes a clamping push rod, a proximal clamp head, a distal clamp head, a clamping operating mechanism and an elastic mechanism. The clamping push rod is movably inserted into the pushing catheter. The proximal clamp head is arranged at the distal end of the pushing catheter. The distal clamp head is arranged at the distal end of the clamping push rod. The elastic mechanism is fixedly connected to the proximal end of the clamping push rod. The clamping operating mechanism is movably connected to the proximal end of the clamping push rod and the elastic mechanism. After the clamping operating mechanism drives the clamping push rod to move from the distal end to the proximal end to close the distal clamp head and the proximal clamp head, the clamping operating mechanism compresses the elastic mechanism, so that the clamping operating mechanism displaces proximally relative to the clamping push rod to give a sound feedback.

[0008] In the valve suture device provided by the present application, due to the provision of the elastic mechanism, when the length of the clamping push rod is not sufficient to enable the clamping operating mechanism to move from the distal end to the proximal end to a predetermined position to give a sound feedback, the elastic mechanism can be compressed so that the clamping operating mechanism displaces proximally relative to the clamping push rod to reach the predetermined position to give a sound feedback, thereby preventing the operator from forcibly moving the clamping operating mechanism proximally to obtain the sound feedback, causing the distal clamp head and the proximal clamp head to excessively clamp the valve leaflet and injuring the valve leaflet, and improving the safety and reliability of the surgery. Description of the Drawings

[0009] Figure 1 It is a schematic structural diagram of the human heart under normal and healthy conditions;

[0010] Figure 2 It is a schematic structural diagram of the human heart under the condition of posterior chordae tendineae rupture;

[0011] Figure 3 It is a three-dimensional schematic diagram of the valve suture device provided by an embodiment of the present application;

[0012] Figure 4 It is Figure 3 The exploded schematic diagram of the valve suture device shown;

[0013] Figure 5 It is a three-dimensional schematic diagram of the suture thread provided by an embodiment of the present application;

[0014] Figure 6a It is a three-dimensional schematic diagram of the probe part of the valve suture device provided by an embodiment of the present application extending out of the pushing catheter;

[0015] Figure 6b It is Figure 6a The enlarged schematic diagram of the local area I of

[0016] Figure 7aSchematic three-dimensional view of the probe of the valve suture device provided by an embodiment of the present application, with the probe completely located in the pushing catheter;

[0017] Figure 7b For Figure 7a Enlarged schematic view of local area II;

[0018] Figure 8 For Figure 6a Exploded schematic view of the valve suture device shown;

[0019] Figure 9 For Figure 7a Exploded schematic view of the valve suture device shown;

[0020] Figure 10 Exploded schematic view of the pushing handle provided by an embodiment of the present application;

[0021] Figure 11 Schematic three-dimensional view of the clamping operation mechanism of the clamping device provided by an embodiment of the present application;

[0022] Figure 12 Exploded schematic view of the clamping operation mechanism of the clamping device provided by an embodiment of the present application;

[0023] Figure 13 Schematic view of the puncture handle and the safety member in the locked state provided by an embodiment of the present application;

[0024] Figure 14 Schematic view of the puncture handle and the safety member in the unlocked state provided by an embodiment of the present application;

[0025] Figure 15 Schematic three-dimensional view of the puncture device and the safety member provided by an embodiment of the present application;

[0026] Figure 16 Another schematic view of the puncture handle and the safety member in the unlocked state provided by an embodiment of the present application;

[0027] Figure 17 Schematic three-dimensional view of the safety member provided by an embodiment of the present application;

[0028] Figure 18 Schematic three-dimensional view of the clamping auxiliary device provided by an embodiment of the present application;

[0029] Figure 19 Schematic three-dimensional view of the auxiliary operation mechanism of the clamping auxiliary device provided by an embodiment of the present application;

[0030] Figure 20 Schematic view of the clamping auxiliary member cooperating with the clamping device to clamp the valve leaflet provided by an embodiment of the present application;

[0031] Figure 21 A cross-sectional view of a push catheter provided by an embodiment of the present application;

[0032] Figures 22 - 33 A schematic diagram of the implementation process of implanting a suture into a valve leaflet by a valve suture device provided by an embodiment of the present application. Detailed implementation manners

[0033] In order to make the objectives, technical solutions, and advantages of the present application clearer, the present application will be further described in detail below with reference to the accompanying drawings.

[0034] It should be understood that expressions such as "including" and "may include" that can be used in the present application indicate the existence of disclosed functions, operations, or constituent elements, and do not limit one or more additional functions, operations, and constituent elements. In the present disclosure, terms such as "including" and / or "having" can be interpreted as indicating a specific characteristic, number, operation, constituent element, component, or a combination thereof, but cannot be interpreted as excluding the existence or possibility of addition of one or more other characteristics, numbers, operations, constituent elements, components, or a combination thereof.

[0035] In addition, in the present application, the expression "and / or" includes any and all combinations of related listed words. For example, the expression "A and / or B" may include A, may include B, or may include both A and B.

[0036] In the present application, expressions including ordinal numbers such as "first" and "second" may modify each element. However, such elements are not limited by the above expressions. For example, the above expressions do not limit the order and / or importance of the elements. The above expressions are only used to distinguish one element from other elements. Without departing from the scope of the present disclosure, the first element may be referred to as the second element, and similarly, the second element may also be referred to as the first element.

[0037] When a component is referred to as "connected" or "accessed" to another component, it should be understood that: the component can not only be directly connected to or accessed to the other component, but there may also be another component between the component and the other component. On the other hand, when a component is referred to as "directly connected" or "directly accessed" to another component, it should be understood that there is no component between them.

[0038] In the technical field of interventional medical devices, generally, the orientation close to the operator is defined as the proximal end, and the orientation far from the operator is defined as the distal end. The direction of the central axis of an object such as a cylinder or a tube is defined as the axial direction. The radial direction refers to the direction passing through the central axis in the radial plane, for example, the straight line direction along the diameter or radius, or the straight line direction perpendicular to the central axis.

[0039] Please refer to Figure 3 and Figure 4 , an embodiment of the present application provides a valve suturing device 100 for implanting a suture 60 (as shown in Figure 5 ) into a patient's body to replace a diseased or ruptured chordae tendineae in the patient's heart; or for implanting multiple sutures 60 into the patient's body and fixing them to each other to achieve edge-to-edge repair of a heart valve (such as a mitral valve or a tricuspid valve). The valve suturing device 100 includes a clamping device 10, a puncturing device 20, a pushing device 30, a clamping assisting device 40, and a detecting device 50. The pushing device 30 is used to transport the clamping device 10 to a predetermined position near the valve. The clamping device 10 is used to accommodate the suture 60 and clamp the valve leaflets. The clamping assisting device 40 is used to support the lower surface of the leaflet and cooperate with the clamping device 10 to clamp the leaflet. The detecting device 50 is used to detect whether the clamping device 10 clamps the valve leaflets and the clamping effect on the leaflets. The puncturing device 20 is used to puncture the valve after the clamping device 10 clamps the valve.

[0040] Taking the chordae tendineae repair of the valve with the suture 60 as an artificial chordae tendineae as an example, a detailed description will be given. Please refer to Figure 5 , the suture 60 includes a suture body 62 with flexibility. The suture body 62 has opposite first and second ends. The first end and / or the second end is connected with a fixing member 64. The fixing member 64 is used for non-removable or removable fixed connection with the puncturing device 20. The fixing member 64 can be arranged at both ends of the suture body 62, or only at one end of the suture body 62. In this embodiment, fixing members 64 are provided at both ends of the suture body 62. The number of sutures 60 can be one, two or multiple. The material of the suture body 62 can be a polymer material compatible with the human body or a relatively soft metal material, etc., preferably polymer materials such as polyethylene terephthalate (PET), expanded polytetrafluoroethylene (e-PTFE), etc. In this embodiment, the suture body 62 is used for implanting into the heart to replace the diseased chordae tendineae in the heart, that is, one end of the suture body 62 is fixed on the leaflet, and the other end is fixed on the ventricular wall or papillary muscle and other parts to replace the diseased chordae tendineae and maintain the tension between the leaflet and the ventricular wall.

[0041] Please refer to in combination Figures 6a to 10, the pushing device 30 includes a pushing catheter 32 and a pushing handle 34 connected to the proximal end of the pushing catheter 32. The pushing handle 34 is used to manipulate the entire valve suture device 100 to be pushed distally or retracted proximally. In this embodiment, the pushing handle 34 includes a first housing 342 and a second housing 344 detachably covering the first housing 342, and the pushing catheter 32 is a tubular body with a certain axial length or a rod-shaped body with an inner cavity.

[0042] Please refer to Figures 6a to 7b , the clamping device 10 includes a clamping push rod 12 accommodating a suture 60, a distal chuck 14 and a proximal chuck 16 for cooperating to clamp the valve leaflet. The distal chuck 14 is provided at the distal end of the clamping push rod 12, and the proximal chuck 16 is provided at the distal end of the pushing catheter 32. The clamping push rod 12 is movably inserted through the inner cavity of the pushing handle 34 and the pushing catheter 32.

[0043] The clamping push rod 12 is a tubular body or a hollow rod-shaped body with a certain axial length, and the cross-section is preferably oval or circular, and a suture channel 122 is provided axially in the clamping push rod 12 (as Figure 4 shown). Two suture receiving cavities 142 communicating with the suture channel 122 are provided in the distal chuck 14 (as Figure 7b shown), and the two suture receiving cavities 142 respectively penetrate to the clamping surface of the distal chuck 14. The suture body 62 of the suture 60 is received in the suture channel 122 and the suture receiving cavities 142. Two fixing cavities 144 for respectively accommodating two fixing members 64 of the suture 60 are further provided on the clamping surface of the distal chuck 14 (as Figure 7b shown). Each fixing cavity 144 is axially communicated with one suture receiving cavity 142.

[0044] Please refer to Figure 4 , Figure 11 and Figure 12 , the clamping device 10 further includes a clamping operation mechanism 18 and an elastic mechanism 19 connected to the proximal end of the clamping push rod 12. The clamping operation mechanism 18 is provided on the pushing handle 34. The clamping operation mechanism 18 is used to drive the distal chuck 14 and the proximal chuck 16 to close or separate. In this embodiment, the shapes of the proximal chuck 16 and the distal chuck 14 are matched with the shape of the pushing catheter 32, and the distal chuck 14 and the proximal chuck 16 form a smooth integral body after closing, so as to facilitate pushing and reduce the damage to the patient's wound.

[0045] The proximal end of the clamping push rod 12 extends from the proximal end of the self-propelling catheter 32. The elastic mechanism 19 is fixedly connected to the proximal end of the clamping push rod 12. The clamping operation mechanism 18 is movably connected to the proximal end of the clamping push rod 12 and the elastic mechanism 19. After the clamping operation mechanism 18 drives the clamping push rod 12 to move from the distal end to the proximal end to close the distal chuck 14 and the proximal chuck 16, the clamping operation mechanism 18 compresses the elastic mechanism 19, causing the clamping operation mechanism 18 to displace proximally relative to the clamping push rod 12 to give an audible feedback.

[0046] Since the valve suturing device 100 is provided with the elastic mechanism 19, when the length of the clamping push rod 12 is not sufficient to move the clamping operation mechanism 18 from the distal end to the proximal end to a predetermined position to give an audible feedback, the elastic mechanism 19 can be compressed so that the clamping operation mechanism 18 displaces proximally relative to the clamping push rod 12 to reach the predetermined position to give an audible feedback, thus preventing the operator from forcibly moving the clamping operation mechanism 18 proximally to obtain the audible feedback, causing the distal chuck 14 and the proximal chuck 16 to overly clamp the leaflet and injure the leaflet. In this way, the safety and reliability of the surgery are improved.

[0047] The inner surface of the second housing 344 of the pushing handle 34 is axially provided with a sliding groove 345 (as Figure 9 shown in Figure 10 ). The clamping operation mechanism 18 includes a connected sliding member 182 and an operating component 184. The sliding member 182 is slidably disposed in the sliding groove 345. The sliding groove 345 is used to guide and limit the movement of the sliding member 182. The elastic mechanism 19 is movably connected to the sliding member 182, and the elastic mechanism 19 is fixedly connected to the proximal end of the clamping push rod 12. The proximal end of the clamping push rod 12 abuts against the sliding member 182. The operating component 184 is used to drive the sliding member 182 to slide axially along the sliding groove 345. Specifically, the sliding member 182 is provided with a push rod mounting hole 1822. The proximal end of the clamping push rod 12 is received in the push rod mounting hole 1822 and abuts against the sliding member 182. A part of the elastic mechanism 19 is received in the push rod mounting hole 1822 and is fixedly connected to the proximal end of the clamping push rod 12. In this way, the elastic mechanism 19 and the clamping push rod 12 are partially inserted into the push rod mounting hole 1822 of the sliding member 182 for connection. The proximal end of the clamping push rod 12 abuts against the sliding member 182 and is held in the push rod mounting hole 1822. The sliding member 182 can compress the elastic mechanism 19 to cause the clamping operation mechanism 18 to displace proximally relative to the clamping push rod 12 to reach the predetermined position to give an audible feedback.

[0048] Further, the operating component 184 is elastically connected to the sliding member 182. The inner surface of the pushing handle 34 is further provided with a guiding groove 347. The operating component 184 is slidably disposed in the guiding groove 347 (as Figure 10As shown in the figure, the guiding groove 347 includes a connected radial guiding groove 3471 and an axial guiding groove 3473. The axial guiding groove 3473 is closer to the central axis of the pushing handle 34 than the radial guiding groove 3471. The guiding groove 347 is generally an L-shaped groove structure, and the radial guiding groove 3471 communicates with the proximal end of the axial guiding groove 3473. The operating assembly 184 can be switched between a natural state and a compressed state. When the operating assembly 184 moves from the axial guiding groove 3471 to the radial guiding groove 3473, the operating assembly 184 is switched from the compressed state to the natural state to impact the pushing handle 34 to generate a sound feedback.

[0049] For convenient operation, operating assemblies 184 are connected to both sides of the sliding member 182. An operating through groove 348 is further provided on the side surface of the pushing handle 34 (as Figure 9 shown in Figure 10 the figure). The operating assembly 184 includes a sliding plate 1841, an operating member 1843, and an elastic member 1845. The sliding plate 1841 is connected to the operating member 1843. The sliding plate 1841 is slidably disposed in the guiding groove 347. The operating member 1843 is clamped in the operating through groove 348 and exposed outside the pushing handle 34. The operating through groove 348 serves to limit the axial moving distance of the clamping operating mechanism 18. By operating the operating member 1843 to move in the operating through groove 348, the sliding member 182 is driven to move, thereby controlling the opening and closing of the distal chuck 14 and the proximal chuck 16. The elastic member 1845 is connected between the sliding member 182 and the sliding plate 1841. When the elastic member 1845 is switched from the compressed state to the natural state, the operating member 1843 impacts the pushing handle 34 to generate a sound feedback, which is convenient for the operator to confirm that the distal chuck 14 and the proximal chuck 16 are closed to clamp the valve leaflet.

[0050] The clamping operating mechanism 18 further includes a mounting rod 186. The mounting rod 186 is connected between the sliding member 182 and the operating member 1843. Specifically, mounting rods 186 are provided on both sides of the sliding member 182 along the radial direction, and the operating member 1841 is connected to the mounting rods 186. The elastic member 1845 is sleeved outside the mounting rod 186 and disposed between the sliding member 182 and the operating member 1843. In the illustrated example, the sliding plate 1841 and the operating member 1843 are integrated, that is, the mounting rod 186 is also connected between the sliding member 182 and the sliding plate 1841.

[0051] When the sliding plate 1843 is located in the radial guiding groove 3471, the distal chuck 14 and the proximal chuck 16 are closed; when the sliding plate 1843 is located in the axial guiding groove 3473, the distal chuck 14 and the proximal chuck 16 are separated. The operating assembly 184 is converted between a natural state and a compressed state through the deformation of the elastic member 1845. The elastic member 1845 can be a spring. When the elastic member 1845 is converted from the natural state to the compressed state, the sliding plate 1843 can move from the radial guiding groove 3471 to the axial guiding groove 3473; when the elastic member 1845 is converted from the compressed state to the natural state, the sliding plate 1843 moves from the axial guiding groove 3471 to the radial guiding groove 3473, so that the operating member 1841 impacts the pushing handle 34 to generate an audible feedback, prompting the operator that the distal chuck 14 and the proximal chuck 16 have been closed.

[0052] The operating member 1843 includes an operating portion 1846, a connecting portion 1847 and a feedback portion 1848 which are connected in sequence. The connecting portion 1847 passes through the operating through groove 348, the operating portion 1843 is located outside the pushing handle 34, and the feedback portion 1848 is received in the inner cavity of the pushing handle 34. When the elastic member 1845 is converted from the compressed state to the natural state, the feedback portion 1848 impacts the inner side surface of the pushing handle 34 to generate an audible feedback. In this embodiment, the feedback portion 1848 extends axially, and the feedback portion 1848 can abut against the inner side surface of the second housing 344 of the pushing handle 34 to enhance the stability of the clamping operation mechanism 18. The operating portion 1846, the connecting portion 1847 and the feedback portion 1848 can be integrally formed or separately provided independently. The present application does not limit the structure of the operating member 1843.

[0053] It can be understood that when the distal chuck 14 and the proximal chuck 16 are closed (as Figure 22 shown), the sliding plate 1841 is located in the radial guiding groove 3471. When the operating portion 1846 is pressed by the operator, the operating member 1843 compresses the elastic member 1845, so that the sliding plate 1841 can move from the radial guiding groove 3471 to the axial groove 3473. At this time, the operating member 1843 is controlled to drive the sliding member 182 and the clamping push rod 12 to move distally, so that the distal chuck 14 moves away from the proximal chuck 16, forming an open state as shown in Figure 23 shown, and a leaflet accommodating space is formed between the distal chuck 14 and the proximal chuck 16. After the distal end of the fine-tuning valve suture device 100 is adjusted so that the leaflet enters the leaflet accommodating space (as Figure 24 shown), the operating member 1843 is controlled to move proximally, the sliding plate 1841 can move from the axial guiding groove 3473 to the radial guiding groove 3471, and at the same time the sliding member 182 drives the clamping push rod 12 to move proximally, so that the distal chuck 14 approaches the proximal chuck 16, forming a state as shown in Figure 20 and Figure 25The clamping state shown. At this time, the valve leaflet is clamped and fixed by the clamping device 10. Since the sliding plate 181 is in the axial guiding groove 3473, the elastic member 1845 is compressed. When the sliding plate 1841 moves from the axial guiding groove 3473 to the radial guiding groove 3471, the elastic member 1845 returns to its natural state and generates an elastic force, causing the feedback portion 1848 to impact the inner side of the pushing handle 34 and giving a "click" sound feedback. When the operator or user hears the "click" sound, it can be determined that the distal chuck 14 and the proximal chuck 16 are closed to clamp the valve leaflet.

[0054] Due to the inevitable tolerance problem in the manufacturing process, there may be a situation where the length of the clamping push rod 12 is insufficient, resulting in that when the distal chuck 14 and the proximal chuck 16 clamp the valve leaflet and close, the sliding plate 1841 cannot move from the axial guiding groove 3473 to the radial guiding groove 3471 to give a sound feedback. However, the operator needs to confirm whether the distal chuck 14 and the proximal chuck 16 are closed according to the sound feedback. In this way, in order to hear the sound feedback, the operator will forcefully move the operating member 1843 proximally. In this application, the clamping push rod 12 and the sliding member 182 are elastically connected by an elastic mechanism 19. The elastic mechanism 19 is compressed to provide space so that when the length of the clamping push rod 12 is insufficient, the sliding plate 1841 can be driven by the operating member 1843 to move from the axial guiding groove 3473 to the radial guiding groove 3471 to give a sound feedback, preventing the distal chuck 14 and the proximal chuck 16 from clamping the valve leaflet too tightly and injuring the valve leaflet.

[0055] In this embodiment, the elastic mechanism 19 includes a first connecting member 191 and an elastic element 193. The first connecting member 191 is movably connected to the clamping operating mechanism 18, specifically movably connected to the sliding member 182 of the clamping operating mechanism 18. The distal end of the first connecting member 191 is fixedly connected to the proximal end of the clamping push rod 12. The proximal end of the clamping push rod 12 abuts against the clamping operating mechanism 18, specifically abuts against the sliding member 182 of the clamping operating mechanism 18. The elastic element 193 is sleeved outside the first connecting member 191 and is located between the proximal end of the first connecting member 191 and the clamping operating mechanism 18.

[0056] Specifically, the first connecting member 191 includes a main body 1911 and a flange 1913 provided at the proximal end of the main body 1911. The main body 1911 is movably inserted through the clamping operation mechanism 18, specifically through the sliding member 182 of the clamping operation mechanism 18. The distal end of the main body 1911 is fixedly connected to the proximal end of the clamping push rod 12. The elastic element 193 is sleeved outside the main body 1911, and the elastic element 193 is located between the flange 1913 and the clamping operation mechanism 18. Among them, the proximal end of the clamping push rod 12 is received in the push rod mounting hole 1822, the main body 1911 and the elastic element 193 are partially received in the push rod mounting hole 1822, the proximal end of the clamping push rod 12 is fixedly connected to the main body 1911 and abuts against the sliding member 182 to be held in the push rod mounting hole 1822. Due to the existence of the flange 1913, when the sliding member 182 moves from the distal end to the proximal end, the elastic element 193 can be compressed, so that the sliding plate 1841 can be driven by the operating member 1843 to move from the axial guide groove 3473 to the radial guide groove 3471 to give a sound feedback.

[0057] Further, the elastic mechanism 17 further includes a second connecting member 194 for accommodating the proximal end of the clamping push rod 12. The second connecting member 194 is fixedly connected between the distal end of the main body 1911 and the proximal end of the clamping push rod 12, that is, the distal end of the main body 1911 is fixedly connected to the second connecting member 194, and the proximal end of the clamping push rod 12 is fixedly connected to the second connecting member 194. Specifically, at least one connecting hole is provided at the distal end of the first connecting member 191, the second connecting member 194, and the proximal end of the clamping push rod 12, and the three can be fixedly connected by means of screws or rivets, etc. In Figure 12 the example of, it is fixedly connected by screws. The proximal end of the clamping push rod 12 is placed in the receiving groove of the second connecting member 194, and the screw sequentially passes through the clamping push rod 12, the second connecting member 194, and the first connecting member 191 to fixedly connect the three.

[0058] In another embodiment, a baffle (not shown in the figure) is provided on the inner surface of the pushing handle 34. The elastic mechanism 17 includes a first connecting member, and the first connecting member is movably connected to the clamping operation mechanism 18, specifically movably connected to the sliding member 182 of the clamping operation mechanism 18. The first connecting member includes an elastic part and a connecting part. The radial dimension of the elastic part is larger than that of the connecting part, the connecting part is fixedly connected to the proximal end of the clamping push rod 12, and the proximal end of the clamping push rod 12 abuts against the clamping operation mechanism 18, specifically against the sliding member 182 of the clamping operation mechanism 18. Both ends of the elastic part respectively abut against the sliding member 182 of the clamping operation mechanism 18 and the baffle.

[0059] Specifically, the proximal end of the clamping push rod 12 is received in the push rod mounting hole 1822, the connecting portion of the first connecting member is received in the push rod mounting hole 1822, the proximal end of the clamping push rod 12 is fixedly connected to the connecting portion and abuts against the sliding member 182 to be held in the push rod mounting hole 1822. The elastic portion of the first connecting member is located outside the push rod mounting hole 1822 and abuts against the sliding member 182. Due to the presence of the baffle, when the sliding member 182 moves from the distal end to the proximal end, it can compress the elastic portion of the first connecting member, so that the sliding plate 1841 can be driven by the operating member 1843 to move from the axial guiding groove 3473 to the radial guiding groove 3471 to give a sound feedback.

[0060] Please refer to again Figure 4 、 Figure 9 、 Figures 13 - 16 , the puncture device 20 penetrates axially through the inner cavity of the pushing handle 34 along the axial direction of the pushing handle 34 and is movably mounted in the pushing catheter 32. The puncture device 20 includes a puncture push rod 22 and a puncture needle 24 provided at the distal end of the puncture push rod 22.

[0061] In this embodiment, the positions of the two fixing cavities 144 formed in the clamping surface of the distal chuck 14 correspond to the positions of the two puncture needles 24 respectively. Thus, the two fixing members 64 of the suture 60 are respectively received in the distal chuck 14, and the proximal end of each fixing member 64 corresponds to a puncture needle 24 respectively. After the puncture needle 24 punctures the valve leaflet, it can be connected to the fixing member 64 of the suture 60 to pull the suture body 62 proximally. The puncture needle 24 and the fixing member 64 form a detachable or non-detachable fixed connection, for example, a threaded connection, an adhesive connection, a friction connection through a rough surface, an interference fit or a snap connection. The shape of the fixing member 64 is matched with different connection methods. Specifically, the outer part of the fixing member 64 is usually cylindrical, and the cross-sectional shape can be various shapes such as circular, oval, polygonal, etc., preferably circular or oval; the inner surface of the fixing member 64 is provided with grooves or holes, and the distal end of the puncture needle 24 is provided with at least one convex tooth or at least one circle of convex edges for forming an interference fit or a snap connection with the fixing member 64. In the illustrated example, the fixing member 64 is cylindrical, and three grooves are radially provided on the inner surface, which are engaged with the convex teeth or convex edges on the puncture needle 24.

[0062] The puncture device 20 further includes a puncture handle 26 connected to the proximal end of the puncture push rod 22. A through hole is provided at the proximal end of the push handle 34, through which the puncture handle 26 of the puncture device 20 can pass. The size of the through hole is adapted to the puncture handle 26. Part of the puncture handle 26 is located in the inner cavity of the push handle 34, and part is located outside the push handle 34. The proximal end of the puncture push rod 22 passes out of the proximal end of the push catheter 32 and is connected to the puncture handle 26. By axially moving the puncture handle 26, the puncture push rod 22 can be driven to axially move along the push catheter 32, thereby driving the puncture needle 24 to puncture distally or retract proximally. After the valve leaf is clamped by the clamping device 10, the puncture needle 24 can be driven by the puncture handle 26 to pierce the valve leaf and connect with the fixing member 64 of the suture 60. The puncture needle 24 and the suture 60 are connected as a whole through the fixing member 64, and the suture 60 is not easily separated from the puncture needle 24. The operator can conveniently and quickly pull one or both ends of the suture 60 connected to the fixing member 64 to the predetermined positions on the ventricular wall or papillary muscle.

[0063] The puncture device 20 further includes a safety member 28. The safety member 28 is movably sleeved outside the puncture handle 26 and movably penetrates through the push handle 34. The safety member 28 is used to lock the puncture handle 26 to restrict the axial movement of the puncture handle 26, so as to prevent the operator from accidentally triggering the puncture handle 26 when puncture is not required. In this embodiment, the safety member 28 can interfere with the puncture handle 26 to lock the puncture handle 26. The push handle 34 is provided with an installation groove 3422 (as shown in Figure 9 and Figure 10 ) that penetrates the inner and outer surfaces, and the safety member 28 penetrates through the installation groove 3422. The inner surface of the push handle 34 is provided with a support member 346 for supporting the puncture handle 26 and the puncture push rod 22, so that the height of the puncture handle 26 in the inner cavity of the push handle 34 is fixed. The support member 346 is provided with a card slot 3462 for accommodating part of the safety member 28.

[0064] Please refer to Figure 17 , the safety member 28 is integrally in an inverted convex shape. The safety member 28 includes a pressing portion 282 and a connecting portion 284 connected. The pressing portion 282 is used for the operator to press and operate. The connecting portion 284 includes a first connecting portion 2842 and a second connecting portion 2844 connected. The radial dimension of the first connecting portion 2842 is smaller than that of the second connecting portion 2844. The first connecting portion 2842 is slidably connected to the card slot 3462. The pressing portion 282 is connected to one end of the second connecting portion 2844 away from the first connecting portion 2842. When the puncture handle 26 and the safety member 28 are in a locked state, the pressing portion 282 is pressed to move the safety member 28 towards the bottom surface of the card slot 3462, so that the first connecting portion 2842 fills the card slot 3462, thereby unlocking the safety member 28 from the puncture handle 26.

[0065] The first connecting portion 2842 is provided with a first receiving groove 281, and the second connecting portion 2844 is provided with a second receiving groove 283 communicating with the first receiving groove 281. The radial space of the second receiving groove 283 is larger than that of the first receiving groove 281. The puncture handle 26 is movably inserted into the second receiving groove 283 and is in clearance fit with the second receiving groove 283. The puncture handle 26 is inserted into the safety member 28 and cooperates with the safety member 28 to reduce the fitting space between the two, which is beneficial to reducing the size of the valve suture device 100.

[0066] More specifically, please refer to again Figure 16 , on the side of the puncture handle 26 facing the card slot 3462, there is an interference portion 262. On both sides of the interference portion 262, depressions are formed to form a first convex block 2622 and a shoulder 2623. When the first convex block 2622 is inserted into the first receiving groove 281, the shoulder 2623 abuts against the first connecting portion 2842 to prevent the axial movement of the puncture handle 26, realizing the locking of the puncture handle 26 by the safety member 28, that is, the safety member 28 and the puncture handle 26 are in a locked state. In this embodiment, the overall radial dimension of the puncture handle 26 is matched with the radial dimension of the second receiving groove 283. When the first convex block 2622 is inserted into the second receiving groove 283, the shoulder 2623 is also located in the second receiving groove 283, and the shoulder 2623 does not abut against the first connecting portion 2842 and the second connecting portion 2844. The puncture handle 26 can move axially relative to the safety member 28 in the second receiving groove 283, that is, the safety member 28 and the puncture handle 26 are in an unlocked state.

[0067] Please refer to again Figure 13 and Figure 17 , on the side of the puncture handle 26 facing away from the card slot 3462, there is also a sliding groove 264, that is, on the side of the puncture handle 26 facing the pressing portion 282, there is a sliding groove 264. The second connecting portion 2844 is further provided with a third receiving groove 285, and the third receiving groove 285 communicates with one end of the second receiving groove 283 away from the first receiving groove 281. The inner surface of the third receiving groove 285 is provided with a second convex block 2822. When the puncture handle 26 is located in the second receiving groove 283 and the third receiving groove 285, at least part of the second convex block 2822 is received in the sliding groove 264. When the puncture handle 26 moves axially relative to the safety member 28, the second convex block 2822 can move along the sliding groove 264 to guide the movement of the puncture handle 26 relative to the safety member 28, improving the smoothness and stability of the movement of the puncture handle 26 relative to the safety member 28. In this embodiment, the radial space of the third receiving groove 285 is larger than that of the second receiving groove 283. It can be understood that the radial space of the third receiving groove 285 can be smaller than or equal to the radial space of the second receiving groove 283, as long as it is ensured that the second convex block 2822 can be inserted into the sliding groove 264. Of course, the third receiving groove 285 and the second convex block 2822 can be omitted.

[0068] When the insurance part 28 locks the puncture handle 26, the pressing part 282 is received in the installation groove 3422, and the pressing part 282 can drive the whole insurance part 28 to move towards the bottom surface of the clamping groove 3462 under force. In this embodiment, when the insurance part 28 and the puncture handle 26 are in a locked state, the pressing part 282 fills the installation groove 3422 and the surface of the pressing part 282 facing away from the clamping groove 3462 is substantially flush with the outer surface of the pushing handle 34. The first connecting part 2842 is clamped in the clamping groove 3462 and there is a certain distance between the surface of the first connecting part 2842 facing the bottom surface of the clamping groove 3462 and the bottom surface of the clamping groove 3462. At this time, the first convex block 2622 is located in the first accommodating groove 281, and the first connecting part 2842 and the shoulder 2623 prevent the puncture handle 26 from being pushed and moved distally.

[0069] When the valve suture device 100 needs to be punctured by the puncture device 20, the pressing part 282 is pressed and moves towards the clamping groove 3462 under force. The first connecting part 2842 fills the clamping groove 3462, and the surface of the first connecting part 2842 facing the bottom surface of the clamping groove 3462 contacts the bottom surface of the clamping groove 3462. At this time, the first convex block 2622 disengages from the first accommodating groove 281, and the whole puncture handle 26 is located in the second accommodating groove 283 and the third accommodating groove 281. The puncture handle 26 can be pushed and moved axially, and the second convex block 2822 slides in the sliding groove 264 to ensure the stability of the pushing of the puncture handle 26.

[0070] Please refer to again Figure 4 and Figure 8 Figure, the detection device 50 is used to detect whether the valve leaf is clamped between the distal clamp 14 and the proximal clamp 16. The detection device 50 includes at least one probe 52 and a probe control mechanism 54 connected to the proximal end of each probe 52. The probe 52 is movably inserted through the inner cavity of the pushing handle 54 and the pushing catheter 32 for detecting whether the clamping device 10 clamps the valve leaf of the valve and the clamping effect on the valve leaf. The probe control mechanism 54 is arranged on the pushing handle 34 and can move relative to the pushing handle 34 for driving the probe 52 to extend (move distally) out of the pushing catheter 32 or retract (move proximally) into the pushing catheter 32. In this embodiment, the detection device 50 includes two probes 52, the two probes 52 are arranged in parallel, and the distances between the two probes 52 and the clamping push rod 12 are substantially equal.

[0071] The axial length of the probe 52 is preferably greater than the axial length of the delivery catheter 32. The probe 52 is movably mounted in the delivery catheter 32. The clamping surface of the proximal chuck 16 is provided with a probe outlet 162 to facilitate the distal end of the probe 52 to extend out of the delivery catheter from the probe outlet 162. Correspondingly, the clamping surface of the distal chuck 14 is provided with a probe receiving cavity 146 opposite to the probe outlet 162 for receiving the distal end of the probe 52. When the proximal chuck 16 and the distal chuck 14 are closed, the distal end of the probe 52 extends out of the probe outlet 162 and is received in the probe receiving cavity 146.

[0072] The probe 52 includes a probe body having a certain length, and the probe body can be a solid or hollow structure. The probe body can be made of a metal material, a polymer material, or a metal-polymer material. For example, the probe body can be a solid rod-shaped or hollow tubular structure with a single-layer or multi-layer composite structure, and can also be formed by winding a single wire or multiple wires.

[0073] When the proximal chuck 16 and the distal chuck 14 are closed, if the valve leaflet is clamped between the proximal chuck 16 and the distal chuck 14 and the edge of the valve leaflet contacts the clamping push rod 12, the distal end of the probe 52 will be blocked by the valve leaflet and cannot continue to move distally after passing through the clamping surface of the proximal chuck 16, indicating that the clamping effect of the valve leaflet is good and puncture can be performed. In addition, when the distal end of the probe 52 is blocked by the valve leaflet and cannot enter the probe receiving cavity, it also indicates that the position between the edge of the valve leaflet and the suture body 62 is relatively fixed, improving the treatment effect. Therefore, the clamping effect of the valve leaflet can be effectively detected by the probe 52 with a mechanical structure, and the instrument has a simple structure and convenient operation.

[0074] Please refer to again Figure 9 、 Figure 13 and Figure 14 As shown in FIGS. 18 and 19, the probe manipulation mechanism 54 further includes a sliding member 542 fixedly connected to the proximal end of the probe 52. The sliding member 542 is axially slidably disposed on the delivery handle 34. When the sliding member 542 slides axially, it drives the probe 52 to move axially.

[0075] In this embodiment, the number of the probes 52 is two, and the number of the sliding members 542 corresponds to the number of the probes 52, which is two. The inner surface of the second housing 344 of the delivery handle 34 is provided with two sliding grooves 3441 symmetric about the central axis of the delivery handle 34 (as shown in FIGS. 18 and 19). Figure 9As shown, each sliding member 542 can move axially in the corresponding sliding groove 3441. The first housing 342 is further provided with two control through grooves 3426 corresponding to the two sliding grooves 3441 one by one. The probe control mechanism 54 further includes a control member 544 provided on the sliding member 542. The control member 544 is inserted through the control through groove 3426. The control member 544 is used to drive the sliding member 542 to slide axially along the push handle 34. The two control members 544 are respectively exposed from the two control through grooves 3426 and are clamped on the outer surface of the first housing 342. The control through groove 3426 can limit the axial movement distance of the probe control mechanism 54. The proximal end of each probe 52 is fixedly connected to the corresponding sliding member 542. When the operator controls the control member 544 axially, the sliding member 542 can be driven to move axially, so as to drive the probe 52 to penetrate out of the push catheter 32 or retract the probe 52 into the push catheter 32.

[0076] The control member 544 is provided with an indication portion 5442 on the side facing the central axis of the push handle 34 in the radial direction (as Figure 15 shown). A mark 341 is provided on the outer surface of the first housing 342 between the two control through grooves 3426 (as Figure 10 shown). In this embodiment, the mark 341 includes a first mark 3411 and a second mark 3412. The first mark 3411 and the second mark 3412 are two different colors. For example, the first mark 3411 is red and the second mark 3412 is green. Control the two control members 544 to move distally respectively. As Figure 26a 、 Figure 26b 、 Figure 26c shown, when at least one indication portion 5442 points to the first mark 3411, it indicates that the clamping effect of the valve leaf is poor; as Figure 27 shown, when both indication portions 5442 point to the second mark 3412, it indicates that the clamping effect of the valve leaf is good. It can be understood that the first mark 3411 and the second mark 3412 are not limited to colors, and the first mark 3411 and the second mark 3412 can be distinguished by other forms. For example, different letters, etc.

[0077] Please refer to again Figure 13 and Figure 14 , the probe control mechanism 54 further includes a guide rail 546 extending in the radial direction. The guide rail 546 is provided on the sliding member 542. The control member 544 is slidably connected to the guide rail 546. Specifically, the guide rail 546 has a guide groove 5460. The control member 544 can be clamped in the guide groove 5460 of the guide rail 546 and move in the radial direction. The control through groove 3426 is L-shaped and includes an axial groove 3427 and a radial groove 3428 connecting the proximal end of the axial groove 3427 (as Figure 10The radial groove 3428 is provided so that the operating member 544 can move radially. When the operating member 544 is in the radial groove 3428, the probe 52 is completely received in the push catheter 32. At this time, the operating member 544 cannot drive the sliding member 542 to move axially, so that the probe 52 can be kept received in the push catheter 32, thereby avoiding misoperation during surgery.

[0078] Furthermore, the inner surface of the second housing 344 of the push handle 34 is provided with a positioning groove 349 (such as Figure 10 As shown in the figure, the probe manipulation mechanism 54 also includes a positioning member 35 and a positioning rod 548. The positioning member 35 is clamped in the positioning groove 349, and the positioning member 35 is provided with a positioning hole 352 for the positioning rod 548 to pass through, and the distal end of the positioning rod 548 is fixed to the sliding member 542. The probe manipulation mechanism 54 also includes a pushing elastic member (such as a spring, not shown in the figure), and the positioning rod 548 is installed in the pushing elastic member, and the proximal end of the pushing elastic member is accommodated in the positioning hole 352 and the distal end abuts the pushing handle 34. When the manipulation member 544 is in the radial groove 3428, the probe 52 is completely located in the pushing catheter 32, and the positioning member 35 compresses the pushing elastic member; when the manipulation member 544 moves from the radial groove 3428 to the axial groove 3427, the distal end of the probe 52 extends from the distal end of the pushing catheter 32 under the elastic action of the pushing elastic member.

[0079] More specifically, in the initial state, the operating member 544 is in the radial groove 3428, the push elastic member on the positioning rod 548 is compressed, and the probe 52 is accommodated in the push catheter 32. When the operating member 544 is moved from the radial groove 3427 to the axial groove 3428, the push elastic member on the positioning rod 548 recovers from the compressed state to the natural state to generate elastic force, and the distal end of the probe 52 can be directly pushed out of the push catheter 32.

[0080] See also Figure 7b , Figure 18 and Figure 19 In order to further strengthen the clamping, the valve suture device 100 further includes a clamping auxiliary device 40. The clamping auxiliary device 40 includes at least one clamping auxiliary arm 42 ( Figure 18 The auxiliary clamping arm 42 is movably installed in the push catheter 32. The auxiliary clamping arm 42 is made of elastic and / or flexible material. The auxiliary clamping arm 42 is used to push the auxiliary clamping arm 42 connected thereto out of the distal end of the push catheter 32 or the distal end of the clamping device 10. The auxiliary clamping arm 42 is used to cooperate with the clamping device 10 to clamp the valve leaflet.

[0081] Further, please refer again to Figure 9 and Figure 18, the clamping assistance device 40 further includes an auxiliary operating mechanism 46 connected to the proximal end of the clamping assistance arm 42. The auxiliary operating mechanism 46 is disposed on the pushing handle 34. The proximal end of the clamping assistance arm 42 passes out of the pushing catheter 32 and the auxiliary operating mechanism 46 is provided. An auxiliary part outlet 321 is provided on the clamping surface of the proximal chuck 16, the side surface of the pushing catheter 32 or the side surface of the proximal chuck 16. Therefore, the auxiliary operating mechanism 46 can drive the clamping assistance arm 42 to push the clamping assistance part 44 out of the distal end of the pushing catheter 32 or the distal end of the clamping device 10.

[0082] An auxiliary arm receiving cavity 328 is axially provided in the pushing catheter 32. Before the puncturing device 20 of the valve suture instrument 100 punctures, both the clamping assistance part 44 and the clamping assistance arm 42 are received in the auxiliary arm receiving cavity 328. In this embodiment, the auxiliary part outlet 321 (as Figure 9 shown) is provided on the side surface of the proximal chuck 16, and the auxiliary part outlet 321 communicates with the auxiliary arm receiving cavity 328. The operator pushes the auxiliary operating mechanism 46 distally, which can drive the clamping assistance arm 42 to push the clamping assistance part 44 out of the auxiliary part outlet 321, so as to support on the lower surface of the valve leaflet, stabilize the pulsating valve leaflet, reduce the movement range of the valve leaflet, and cooperate with the clamping device 10 to clamp and fix the valve leaflet.

[0083] The clamping assistance arm 42 is a rod-shaped or tubular structure with a certain axial length, and has a certain hardness or stiffness to provide support and pushability. The clamping assistance arm 42 can be made of a metal rod or a polymer material rod with a hollow or solid structure of a single-layer or multi-layer composite structure, and can also be made of a single wire or multiple wires wound. The clamping assistance arm 42 can be made of a metal material, a polymer material or a metal-polymer composite material.

[0084] Please refer to Figure 20 , the clamping assistance part 44 supports on the lower surface of the valve leaflet 200 and cooperates with the clamping device 10 to clamp the valve leaflet 200. Since the clamping assistance part 44 is made of an elastic and / or flexible material, it can adapt to the anatomical structure of the valve leaflet 200 and the movement range of the valve leaflet 200, and avoid damaging the valve leaflet 200. The elastic material is preferably a shape memory material. The clamping assistance part 44 can be made of a metal material, a polymer material or a metal-polymer composite material. In this embodiment, the clamping assistance part 44 is made of an elastic nickel-titanium alloy with a shape memory function.

[0085] For easy pushing in the pushing catheter 32, the clamping auxiliary 44 includes a compressed state and an extended state in its natural state. When in the compressed state, the clamping auxiliary 44 can be received in the auxiliary arm receiving cavity 328 of the pushing catheter 22 and pushed. When the clamping auxiliary 44 extends out from the auxiliary outlet 321, it changes to the extended state and can support on the lower surface of the valve leaf 200 to stabilize the pulsating valve leaf 200. In this embodiment, the clamping auxiliary 44 is a mesh structure woven from multiple metal wires. The mesh structure can be further heat-set to form structures such as spherical, columnar, nest-shaped, and oblate spherical. Preferably, the clamping auxiliary 44 is a woven tennis ball-shaped structure. When in the compressed state, the woven tennis ball-shaped structure is radially compressed and received in the auxiliary arm receiving cavity 328; when in the extended state, the woven tennis ball-shaped structure is pushed out from the auxiliary outlet 321 and self-expands radially to form a spherical shape.

[0086] The contact surface of the clamping auxiliary 44 with a larger diameter and the valve leaf 200 is the plane where the clamping auxiliary 44 is located. Therefore, the contact area between the clamping auxiliary device 40 and the valve leaf is larger, which can better fit the valve leaf and improve the support of the clamping auxiliary device 40 for the valve leaf. The outer shape of the clamping auxiliary 44 is smooth. The distal end of the clamping auxiliary 44 can be formed into a smooth round head through processes such as laser spot welding, without defects such as burrs, edges, or corners. It can be understood that the present application is not limited to the clamping auxiliary 44 being a mesh structure. In other embodiments, the clamping auxiliary 44 may further include a support rod or a deformed structure composed of multiple support rods. The deformed structure is an open fork structure, umbrella structure, or closed-loop structure composed of multiple support rods. As long as the clamping auxiliary 44 can support on the lower surface of the valve leaf and cooperate with the clamping device 10 to clamp the valve leaf.

[0087] Please refer to again Figure 9 And Figure 18 , the auxiliary manipulation mechanism 46 is provided on the pushing handle 34. Specifically, a sliding groove 3448 (as shown in Figure 9 ) is provided on the inner surface of the second housing 344 of the pushing handle 34, and a corresponding manipulation through groove 3424 is provided on the first housing 342. The auxiliary manipulation mechanism 46 includes a sliding member 462 and a manipulation member 464 provided on the sliding member 462. The proximal end of the clamping auxiliary arm 42 is fixedly connected to the sliding member 462. The sliding member 462 can move axially in the sliding groove 3448, and the manipulation member 464 is exposed from the manipulation through groove 3424 and is clamped on the outer surface of the first housing 342. The manipulation through groove 3424 can limit the axial movement distance of the auxiliary manipulation mechanism 46. The axial movement of the manipulation member 464 along the manipulation through groove 3424 can drive the sliding member 462 to move axially in the sliding groove 3448, thereby pushing the clamping auxiliary arm 42 to drive the clamping auxiliary 44 to pass out from the auxiliary arm receiving cavity 328 through the auxiliary outlet 321 or retract the clamping auxiliary 44 into the auxiliary arm receiving cavity 328.

[0088] Furthermore, the auxiliary manipulation mechanism 46 further includes a guide rail 466 disposed on the sliding member 462. The guide rail 466 has a guide rail groove, and the manipulation member 464 can be clamped in the guide rail groove and move radially. The manipulation through groove 3424 is generally Z-shaped, including an axial through groove and a radial through groove connecting both ends of the axial through groove. The arrangement of the radial through groove of the manipulation through groove 3424 allows the manipulation member 464 to move radially. When the manipulation member 464 is in the radial through groove of the manipulation through groove 3424, the manipulation member 464 cannot drive the sliding member 462 to move axially. Thus, when it is necessary to keep the clamping auxiliary member 44 received in the auxiliary arm receiving cavity 328 or in the state where the clamping auxiliary member 44 penetrates out of the auxiliary member outlet 321, the operator can be prevented from accidentally operating and moving the manipulation member 464 axially.

[0089] Please refer to Figure 21 , a puncture push rod channel 322, a clamping push rod channel 324 and a probe channel 326 are axially provided in the push catheter 32. The clamping push rod 12 is inserted through the clamping push rod channel 324 of the push catheter 32, the puncture push rod 22 is inserted through the puncture push rod channel 322 of the push catheter 32, and the probe 52 is inserted through the probe channel 326 of the push catheter 32 to ensure that the axial directions of the clamping push rod 12, the puncture push rod 22 and the probe 52 are substantially parallel to the axial direction of the push catheter 32. The clamping push rod channel 324 is disposed on one side of the push catheter 32, and the two puncture push rod channels 322 are disposed on the other side of the push catheter 32. The probe channel 326 is disposed between the clamping push rod channel 324 and the puncture push rod channel 322, and the distance between the probe channel 326 and the clamping push rod channel 324 is less than the distance between the probe channel 326 and the puncture push rod channel 322. It can be understood that when the push catheter 32 further has an auxiliary arm receiving cavity 328, the auxiliary arm receiving cavity 328 is disposed between the clamping push rod channel 324 and the puncture push rod channel 322, the probe channel 326 is disposed between the clamping push rod channel 324 and the auxiliary arm receiving cavity 328, and the distance between the probe channel 326 and the clamping push rod channel 324 is less than the distance between the probe channel 326 and the puncture push rod channel 322.

[0090] The push catheter 32 can be a multi-lumen tube formed by integral molding, or an outer tube and an inner tube can be sleeved and fixed together to form the push catheter 32 with an integral structure. The push catheter 32 can be made of a biocompatible polymer material (for example, polyoxymethylene POM, polyethylene PE, nylon PA, polyvinyl chloride PVC, acrylonitrile-butadiene-styrene copolymer ABS, nylon elastomer Pebax or polyurethane PU), a metal material (for example, stainless steel or nitinol alloy) or a metal-polymer composite material.

[0091] The clamping operating mechanism 18, the auxiliary operating mechanism 46, and the probe control mechanism 54 are all arranged on the pushing handle 34. From the distal end to the proximal end, they are the clamping operating mechanism 18, the auxiliary operating mechanism 46, and the probe control mechanism in sequence. The sliding member 182 is provided with an axially extending through hole for the clamping auxiliary arm 42, the probe 52, and the puncture push rod 22 to pass through. On both sides of the central axis of the pushing handle 34, the sliding member 462 is respectively provided with axially extending through grooves and through holes for the probe 52 and the puncture push rod 22 to pass through. The sliding member 542 is provided with a support portion 5422 (as shown in Figure 15 ) radially towards the central axis of the pushing handle 34. The support portion 5422 has the same height as the support member 346, and they jointly support the puncture push rod 22 and the puncture handle 26.

[0092] Please refer to again Figure 8 , the pushing device 30 further includes a sealing tube 36 communicating with the pushing catheter 32. The sealing tube 36 is located in the inner cavity of the pushing handle 34 and is connected to the proximal end of the pushing catheter 32. The puncture device 20, the probe 52, the clamping push rod, and the clamping auxiliary arm are all movably inserted through the sealing tube 36. In this embodiment, the sealing tube 36 is provided with a Luer connector 362 for connecting an exhaust pipe (not shown in the figure) for exhausting gas. The sealing tube 36 is located in the inner cavity formed between the first housing 342 and the second housing 344. An installation hole 3440 is opened on the distal side surface of the pushing handle 34 for installing the Luer connector 362. The outer surface of the distal end of the sealing tube 36 is formed with a thread and is threadedly connected to a mounting member 38 with an internal thread, so as to fixedly connect the pushing catheter 32 to the pushing handle 34.

[0093] The distal end of the sealing tube 36 is communicated with the proximal end of the pushing catheter 32. The proximal end of the sealing tube 36 is open and filled with at least one sealing member 37. The sealing member 37 is provided with a through hole (not shown in the figure) for the puncture device 20, the probe 52, the clamping push rod, and the clamping auxiliary arm to pass through. In this embodiment, the sealing member 37 includes sealing silica gel. The sealing member 37 is fixed by a fixing nut 33 threadedly connected to the proximal end of the sealing tube 36. The pushing catheter 32 is provided with a plurality of axially arranged and mutually separated through cavities or channels. Correspondingly, the sealing member 37 is also provided with a plurality of mutually separated through holes. It can be understood that the material of the sealing member 37 is not limited in this application, and the connection method between the sealing member 37 and the sealing tube 36 is not limited. For example, in other embodiments, it can be bonded by a colloid or by clamping, etc.

[0094] Taking the chordae tendineae implantation for mitral posterior leaf clamping as an example, the implementation process of the valve suture device 100 provided in this embodiment is briefly described below.

[0095] The first step, please refer to Figure 22 , first push the valve suture device 100 into the left ventricle, and continue to push the valve suture device 100 until both the distal clamp 14 and the proximal clamp 16 are located in the left atrium.

[0096] For the second step, please refer to Figure 23 , control the operating member 1841 to move distally to push the clamping push rod 12 distally, so that the proximal chuck 16 is separated from the distal chuck 14. At this time, a leaflet accommodation space is formed between the proximal chuck 16 and the distal chuck 14.

[0097] For the third step, please refer to Figure 24 , control the operating member 464 to move distally to drive the clamping auxiliary arm 42 to push the clamping auxiliary member 44 out of the auxiliary member outlet 321. At this time, the clamping auxiliary member 44 supports on the lower surface of the leaflet to assist in stabilizing the pulsating leaflet. Keep the relative position between the operating member 1841 and the operating member 464 unchanged, and slowly move the entire instrument proximally until the leaflet enters the leaflet accommodation space formed between the proximal chuck 16 and the distal chuck 14, and the clamping auxiliary member 44 can provide a certain supporting force to the leaflet.

[0098] For the fourth step, please refer to Figure 25 , slightly move the distal end of the valve stapler 100 until the edge of the leaflet contacts the clamping push rod 12. At this time, withdraw the operating member 1841 proximally to drive the distal chuck 14 to move proximally until it closes with the proximal chuck 16, and the leaflet is clamped. If the operator finds that the leaflet is not effectively clamped, the relative position between the distal chuck 14 and the proximal chuck 16 can be finely adjusted to create a certain distance between them, and then the relative position between the clamping push rod 12 and the leaflet can be adjusted. During the adjustment process, since the clamping auxiliary device 40 below the leaflet has a certain supporting effect on the leaflet, it can prevent the leaflet from slipping out of the clamping device 10.

[0099] For the fifth step, keep the position of the pushing handle 34 unchanged, and respectively control the two operating members 544 to move distally to drive the probe 52 to move distally along the axial direction of the pushing catheter 32; as Figures 26a to 26c shown, if the leaflet clamping state is poor, that is, the leaflet does not completely cover the probe outlet 162 on the clamping surface of the proximal chuck 16, the distal end of the probe 52 can extend out of the probe outlet 162 and enter the probe receiving cavity 146 of the distal chuck 14, and the operations of the second to fourth steps need to be repeated to re-clamp the leaflet; as Figure 27 shown, if the leaflet clamping state is good, that is, the leaflet completely covers the probe outlet 162 on the clamping surface of the proximal chuck 16, the distal end of the probe 52 cannot extend out of the probe outlet 162 and enter the probe receiving cavity 146 of the distal chuck 14. At this time, operate the two operating members 544 proximally to the radial groove 3428 of the operating through groove 3426 to drive the probe 52 to retract into the pushing catheter 32, and then subsequent operations can be performed.

[0100] For the sixth step, as Figure 28As shown, press the pressing portion 282 of the safety member 28 to unlock the locked state of the puncture handle 26. At this time, the puncture handle 26 can be pushed distally to drive the puncture needle 24 to move distally until the puncture needle 24 passes through the valve leaflet 200 and forms a fixed connection with the fixing member 64 of the suture 60, as Figure 30 shown.

[0101] Step 7, refer to Figure 31 and Figure 32 , withdraw the puncture handle 26, so that the puncture needle 24 drives the fixing member 64 of the suture 60 and the suture body 62 connected to the fixing member 64 to pass through the valve leaflet 200 in sequence.

[0102] Step 8, continue to withdraw the puncture handle 26 until the fixing member 64 withdraws from the proximal end of the pushing handle 34, then withdraw the operating member 464 to drive the clamping auxiliary member 44 to retract into the auxiliary arm receiving cavity 328, withdraw the entire valve suture device 100, and adjust the length of the suture body 62 remaining in the heart, and fix the two ends of the suture body 62 on the ventricular wall respectively to complete the implantation of the suture 60 (as Figure 33 shown).

[0103] The above is only the preferred embodiment of the present application, and does not impose any form of limitation on the present application. Although the present application has been disclosed above in the preferred embodiment, it is not intended to limit the present application. Any person skilled in the art can make many possible changes and modifications to the technical solution of the present application by using the methods and technical contents disclosed above, or modify it into an equivalent embodiment with equivalent changes. Therefore, any simple modification, equivalent change and modification made to the above embodiment according to the technical essence of the present application without departing from the technical solution of the present application still fall within the scope of the protection of the technical solution of the present application.

Claims

1. A valve suture apparatus, characterized in that, Comprising: A pushing device, the pushing device including a pushing catheter and a pushing handle provided at the proximal end of the pushing catheter; And A clamping device, the clamping device including a clamping push rod, a proximal chuck, a distal chuck, a clamping operation mechanism and an elastic mechanism. The clamping push rod is movably inserted into the pushing catheter. The proximal chuck is provided at the distal end of the pushing catheter. The distal chuck is provided at the distal end of the clamping push rod. The clamping operation mechanism is provided on the pushing handle. The elastic mechanism is fixedly connected to the proximal end of the clamping push rod. The clamping operation mechanism is movably connected to the proximal end of the clamping push rod and the elastic mechanism. The elastic mechanism includes an elastic element or elastic part that can be compressed by the clamping operation mechanism. After the clamping operation mechanism drives the clamping push rod to move from the distal end to the proximal end to close the distal chuck and the proximal chuck, the clamping operation mechanism compresses the elastic element or the elastic part, causing the clamping operation mechanism to displace proximally relative to the clamping push rod, and the clamping operation mechanism impacts the pushing handle to give an audible feedback.

2. The valve suturing device according to claim 1, characterized in that, The elastic mechanism further includes a first connecting member, the first connecting member being movably connected to the clamping operation mechanism. The distal end of the first connecting member is fixedly connected to the proximal end of the clamping push rod. The proximal end of the clamping push rod abuts against the clamping operation mechanism. The elastic element is sleeved outside the first connecting member and is located between the proximal end of the first connecting member and the clamping operation mechanism.

3. The valve suture device according to claim 2, wherein The first connecting member includes a main body and a flange provided at the proximal end of the main body. The main body is movably inserted into the clamping operation mechanism. The distal end of the main body is fixedly connected to the proximal end of the clamping push rod. The elastic element is sleeved outside the main body. The elastic element is located between the flange and the clamping operation mechanism.

4. The valve suturing device according to claim 3, wherein, The elastic mechanism further includes a second connecting member, the second connecting member being fixedly connected between the distal end of the main body and the proximal end of the clamping push rod.

5. The valve suturing device according to claim 1, wherein, The inner surface of the pushing handle is provided with a baffle. The elastic mechanism includes a first connecting member, the first connecting member being movably connected to the clamping operation mechanism. The first connecting member further includes a connecting portion. The radial dimension of the elastic part is larger than the radial dimension of the connecting portion. The connecting portion is fixedly connected to the proximal end of the clamping push rod. The proximal end of the clamping push rod abuts against the clamping operation mechanism. The two ends of the elastic part respectively abut against the clamping operation mechanism and the baffle.

6. The valve suture instrument according to claim 1, characterized in that The inner surface of the pushing handle is axially provided with a sliding groove. The clamping operation mechanism includes a sliding member and an operation component connected thereto. The sliding member is slidably disposed in the sliding groove. The elastic mechanism is movably connected to the sliding member. The elastic mechanism is fixedly connected to the proximal end of the clamping push rod. The proximal end of the clamping push rod abuts against the sliding member. The operation component drives the sliding member to axially slide along the sliding groove.

7. The valve suture apparatus according to claim 6, wherein, The operating assembly is elastically connected to the sliding member. The inner surface of the pushing handle is further provided with a guiding groove, and the operating assembly is slidably disposed in the guiding groove. The guiding groove includes a radially connected guiding groove and an axially connected guiding groove. The axially connected guiding groove is closer to the central axis of the pushing handle than the radially connected guiding groove. The operating assembly can be switched between a natural state and a compressed state. When the operating assembly moves from the axially connected guiding groove to the radially connected guiding groove, the operating assembly is switched from the compressed state to the natural state to impact the pushing handle to generate a sound feedback.

8. The valve suturing device according to claim 7, characterized in that, The side surface of the pushing handle is further provided with an operating through groove. The operating assembly includes a sliding plate, an operating member, and an elastic member. The sliding plate is connected to the operating member. The sliding plate is slidably disposed in the guiding groove. The operating member is clamped in the operating through groove and exposed outside the pushing handle. The elastic member is connected between the sliding member and the sliding plate. When the elastic member is switched from the compressed state to the natural state, the operating member impacts the pushing handle to generate a sound feedback.

9. The valve suture device according to claim 8, wherein, The operating member includes an operating portion, a connecting portion, and a feedback portion connected in sequence. The connecting portion passes through the operating through groove. The operating portion is located outside the pushing handle. The feedback portion is received in the inner cavity of the pushing handle. When the elastic member is switched from the compressed state to the natural state, the feedback portion impacts the inner side surface of the pushing handle to generate a sound feedback.

10. The valve suturing device according to claim 8, wherein, The clamping operation mechanism further includes a mounting rod. The mounting rod is connected between the sliding member and the operating member. The elastic member is sleeved outside the mounting rod.

11. The valve suturing device according to claim 1, wherein, The pushing device further includes a sealing tube communicating with the pushing catheter. The sealing tube is located in the inner cavity of the pushing handle and is connected to the proximal end of the pushing catheter. The clamping push rod is movably inserted through the sealing tube.

12. The valve suture device according to claim 11, wherein The distal end of the sealing tube communicates with the proximal end of the pushing catheter. The proximal end of the sealing tube is open and filled with at least one sealing member. The sealing member is provided with a through hole for the clamping push rod to pass through.

13. The valve suture device according to claim 1, wherein, The valve suture device further includes a puncture device. The puncture device is movably inserted through the pushing catheter. The puncture device includes a puncture push rod and a puncture needle provided at the distal end of the puncture push rod.

14. The valve suturing device according to claim 1, wherein, The valve suture device further includes a detection device. The detection device includes at least one probe. The probe is movably inserted through the pushing catheter. The clamping surface of the proximal chuck is provided with a probe outlet. The clamping surface of the distal chuck is provided with a probe receiving cavity opposite to the probe outlet. When the distal chuck and the proximal chuck are closed, the distal end of the probe extends out of the probe outlet and is received in the probe receiving cavity.

15. The valve suturing device according to claim 1, wherein, The valve suture device further includes a clamping auxiliary device, the clamping auxiliary device includes at least one clamping auxiliary arm and a clamping auxiliary member provided at the distal end of the clamping auxiliary arm, the clamping auxiliary arm is movably mounted in the push catheter, the clamping auxiliary member is made of elastic and / or flexible material, the clamping auxiliary arm pushes the clamping auxiliary member connected thereto to penetrate out from the distal end of the push catheter or the distal end of the clamping device, and the clamping auxiliary member cooperates with the clamping device to clamp the valve leaflet.

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