A valve regurgitation blocking device

Abstract

The present invention relates to a valve regurgitation blocking device, belonging to the technical field of medical devices. It includes an upper clip assembly, a lower clip assembly, a base, a locking mechanism, a connecting rod arm and a blocking component; a movable locking mechanism is provided on the base, and a clamping component for clamping the valve is provided on one side of the outer periphery of the locking mechanism; the clamping component includes an upper clip assembly and a lower clip assembly on one side and a connecting rod arm for opening the lower clip assembly through a connecting rod mechanism; the other side of the outer periphery of the locking mechanism includes a lower clip assembly and a connecting rod arm, and a blocking component is provided on the lower clip assembly on this side. The present invention anchors the clamping component on one side at the position of the diseased valve, and the blocking component on the other side can block the blood reflux beam at the reflux orifice; and when the reflux is blocked by the blocking component, valve stenosis is not caused. The blocking component can be compressed, and the whole device can be deformed and reduced to be implanted through the femoral vein in a minimally invasive manner to repair the mitral and tricuspid valves.

Description

Technical Field

[0001] The present invention relates to a valve regurgitation blocking device, belonging to the technical field of medical devices. As used herein, "upper" refers to the end facing the atrium, and "lower" refers to the end facing the ventricle. Background Art

[0002] The atrioventricular valves include the mitral valve and the tricuspid valve, which are located between the atrium and the ventricle. The atrioventricular valves are one-way valves. When open, they allow blood to flow from the atrium to the ventricle; when closed, they should prevent blood from flowing back into the atrium. If there are structural or functional abnormalities, mitral and tricuspid valve regurgitation may occur. In response to this situation, the traditional treatment method is surgical, repairing or replacing the valve for the patient. In recent years, with the development of technology, medical device manufacturers at home and abroad have developed a batch of interventional devices for treating mitral regurgitation. There are mainly edge-to-edge repair technology, annuloplasty technology, annuloplasty, chordae tendineae implantation technology, etc. Among them, the edge-to-edge repair technology has a long history and better safety, and currently leads other repair technologies. Abbott MitraClip (CN 102395331B) and Edwards PASCAL (US 2019 / 0321166 A1) are typical representatives. When applying this type of technology, a special clip is used to deliver the clip through the catheter along the blood vessel to near the mitral valve and tricuspid valve, and the free edges of the valve leaflets are clamped and fixed, so that the valve leaflets are opposed at the end of systole, reducing regurgitation. However, when applying this type of technology, the opening of the valve during diastole is restricted, more or less causing valve stenosis. Therefore, there is an urgent need in this technical field for a valve repair device that can effectively treat valve regurgitation and avoid causing valve stenosis. Summary of the Invention

[0003] The object of the present invention is to solve the technical problem of how to overcome the deficiencies of the prior art and provide an interventional repair device for the mitral and tricuspid valves that can effectively treat valve regurgitation and avoid causing valve stenosis.

[0004] To achieve the above object, the technical solution adopted by the present invention is to provide a valve regurgitation blocking device, including a blocking component and a clamping component; the clamping component includes an upper clip assembly, a lower clip assembly, a base, a locking mechanism and a connecting rod arm; a movable locking mechanism is sleeved on the base, two openable and closable lower clip assemblies are arranged on the outer periphery of the locking mechanism, and a connecting rod arm for opening the lower clip assemblies through a connecting rod mechanism; an openable and closable upper clip assembly is arranged between one of the lower clip assemblies and the locking mechanism, and a blocking component is arranged on the other lower clip assembly; a space for clamping the valve is arranged between the upper clip assembly and a corresponding lower clip assembly.

[0005] Preferably, the base includes a base body and a base support rod, and the end of the base support rod close to the ventricle is vertically arranged on the base body.

[0006] Preferably, a locking mechanism is sleeved on the base support rod. The locking mechanism includes a locking seat movably connected to the base body. The locking seat is provided with a hollow cavity for passing through the base support rod. A convex platform for limiting is provided on the inner wall of the cavity. A connection hole for connecting with the lower clamping assembly is provided on the locking seat.

[0007] Preferably, an upper clamping assembly is sleeved on the base support rod. The upper clamping assembly includes an upper clamping connection bottom plate and an elastic upper clamping plate with a shape memory function provided at one end of the upper clamping connection bottom plate. A through hole for passing through the base support rod is provided on the upper clamping connection bottom plate. The elastic upper clamping plate is arranged outside the locking mechanism. A rough structure for clamping the valve is provided on the side of the elastic upper clamping plate away from the locking mechanism. The rough structure includes a toothed structure, a barbed structure or a convex structure. A threading hole is further provided on the elastic upper clamping plate. A pulling wire for pulling the elastic upper clamping plate is provided in the threading hole.

[0008] Preferably, the lower clamping assembly includes a lower clamping bottom plate and lower clamping side plates vertically arranged on both sides of the lower clamping bottom plate facing the locking mechanism. A cavity for clamping the valve is formed among the lower clamping bottom plate, the lower clamping side plates on both sides and the elastic upper clamping plate. The lower clamping side plate extends towards the ventricle side to be provided with a hinge plate. A hinge hole movably connected to the locking seat is provided on the hinge plate. A linkage hole movably connected to the connecting rod arm is further provided on the hinge plate.

[0009] Preferably, the connecting rod arm is arranged below the lower clamping assembly and includes a connecting rod bottom plate and connecting rod side plates perpendicular to the connecting rod bottom plate on both sides of the connecting rod bottom plate facing the locking mechanism. One end of the connecting rod side plate close to the ventricle is movably connected to the base body, and the other end of the connecting rod side plate away from the ventricle is movably connected to the hinge plate.

[0010] Preferably, the blocking component is arranged outside another lower clamping assembly away from the locking mechanism or on the front and back sides in the direction perpendicular to the opening and closing plane of the lower clamping assembly.

[0011] Preferably, the blocking component is a structure woven by shape memory metal, including a structure thermally formed by weaving nickel-titanium wires. The shape of the blocking component includes a flat spherical shape, a triangular shape, an elliptical spherical shape, a cylindrical shape, a pot lid shape, a hemispherical shape or a petal shape. A film of a polymer material is coated on the outer surface of the blocking component.

[0012] Preferably, the blocking component is a sheet-shaped biological tissue membrane, including a membrane tissue made of animal pericardium or an animal heart valve.

[0013] Preferably, the outer surfaces of the upper clamping assembly, the lower clamping assembly, the base, the locking mechanism, the connecting rod arm and the blocking component are coated with a biocompatible polymer coating.

[0014] Compared with the prior art, the present invention has the following beneficial effects:

[0015] The valve regurgitation blocking device provided by the present invention is anchored at the position of the diseased valve through a clamping component, and the blocking component can block the blood regurgitation beam at the valve regurgitation orifice; and when the regurgitation is blocked by the blocking component, valve stenosis is not caused. The blocking component can be compressed, and the clamping device can be deformed and reduced in size. The device can be implanted through the femoral vein in a minimally invasive manner to repair the mitral and tricuspid valves. Brief Description of the Drawings

[0016] Figure 1 It is a schematic structural diagram of a valve regurgitation blocking device of the present invention;

[0017] Figure 2 It is a schematic structural diagram of the upper clamping component of a valve regurgitation blocking device of the present invention;

[0018] Figure 3 It is a schematic structural diagram of the lower clamping component of a valve regurgitation blocking device of the present invention;

[0019] Figure 4 It is a schematic structural diagram of the unopened lower clamping component of a valve regurgitation blocking device of the present invention;

[0020] Figure 5 It is a schematic structural diagram of the blocking component of a valve regurgitation blocking device of the present invention;

[0021] Figure 6 It is a schematic overall structural diagram of a valve regurgitation blocking device of the present invention when the blocking component is a sheet-shaped biological tissue membrane;

[0022] Figure 7 It is a schematic structural diagram of a valve regurgitation blocking device of the present invention when working after being implanted into the human body.

[0023] Figure 8 It is a schematic exploded view of the clamping component of a valve regurgitation blocking device of the present invention;

[0024] Reference Numerals: 1. Upper clamping component; 11. Elastic upper clamping plate; 12. Thread passing hole; 13. Upper clamping connection bottom plate; 14. Rough structure; 15. Upper clamping through hole; 16. Upper clamping guiding and limiting hole; 2. Lower clamping component; 21. Lower clamping bottom plate; 22. Lower clamping side plate; 23. Hinge plate; 24. Hinge hole; 25. Linkage hole; 3. Base; 31. Base body; 32. Base support rod; 33. Base connection hole; 4. Locking mechanism; 41. Locking seat; 411. Locking seat bottom plate hole; 412. Locking hinge hole; 42. Boss; 5. Blocking component; 6. Linkage arm; 61. Linkage bottom plate; 62. Linkage side plate; 63. Linkage hinge hole; 64. Linkage linkage hole. Detailed Description of the Embodiments

[0025] To make the present invention more obvious and understandable, the following is a detailed description with preferred embodiments and in conjunction with the accompanying drawings:

[0026] such as Figure 1-8As shown in the figure, the present invention provides a valve regurgitation blocking device, which includes a blocking component 5 and a clamping component; the clamping component includes an upper clamping assembly 1, a lower clamping assembly 2, a base 3, a locking mechanism 4 and a connecting rod arm 6; a movable locking mechanism 4 is sleeved on the base 3, two openable and closable lower clamping assemblies 2 are arranged on the outer periphery of the locking mechanism 4, and a connecting rod arm 6 for opening the lower clamping assembly 2 through a connecting rod mechanism; an openable and closable upper clamping assembly 1 is arranged between one lower clamping assembly 2 and the locking mechanism 4, and a blocking component 5 is arranged on the other lower clamping assembly 2; a space for clamping the valve is arranged between the upper clamping assembly 1 and a corresponding lower clamping assembly 2. The base 3 includes a base body 31 and a base support rod 32, and one end of the base support rod 32 close to the ventricle is vertically arranged on the base body 31. The locking mechanism 4 is sleeved on the base support rod 32, and the locking mechanism 4 includes a locking seat 41 movably connected to the base body 31; the locking seat 41 is provided with a hollow cavity for passing through the base support rod 32; a limiting boss 42 is arranged on the inner wall of the cavity; a connection hole for connecting with the lower clamping assembly is arranged on the locking seat 41. The upper clamping assembly 1 is sleeved on the base support rod 32, and the upper clamping assembly 1 includes an upper clamping connection bottom plate 13 and an elastic upper clamping plate 11 with shape memory function arranged at one end of the upper clamping connection bottom plate 13; a through hole for passing through the base support rod 32 is arranged on the upper clamping connection bottom plate 13, and the elastic upper clamping plate 11 is arranged outside the locking mechanism 4; a rough structure ...... It should be noted that the original text seems to be incomplete at the end of the description of the rough structure 14 in the upper clamping plate 11. The translation is carried out according to the existing content. If you can provide the complete original text, a more accurate translation can be obtained.The outer surfaces of the upper clamping assembly 1, the lower clamping assembly 2, the base 3, the locking mechanism 4, the connecting rod arm 6 and the blocking member 5 are coated with a biocompatible polymer film.

[0027] Embodiment

[0028] As Figure 1-8 shown, a valve regurgitation blocking device provided by the present invention includes an upper clamping assembly 1, a lower clamping assembly 2, a base 3, a locking mechanism 4, a connecting rod arm 6 and a blocking member 5. After the valve regurgitation blocking device of the artificial heart valve is implanted into the human body through a minimally invasive surgical approach, it can effectively treat mitral regurgitation (MR) and tricuspid regurgitation (TR).

[0029] Among them, the lower clamping assembly 2 is provided in two groups and is symmetrically and movably connected to both sides of the locking mechanism 4. Of course, multiple ones can also be set according to actual needs. One side is provided with an upper clamping assembly 1 and a corresponding lower clamping assembly 2 that are opened and closed in a matching manner to form a clamping portion. The blocking member 5 is provided on the lower clamping assembly 2 on the other side.

[0030] The lower clamping assembly 2, the base 3, the locking mechanism 4 and the connecting rod arm 6 form a four-bar linkage mechanism, making the opening and closing of the valve regurgitation blocking device easier to operate.

[0031] Among them, the base 3 includes a base body 31 and a base support rod 32, and the base support rod 32 is vertically provided on the upper surface of the base body 31. Two base connection holes 33 are provided on the side surface of the base body 31.

[0032] The locking mechanism 4 is sleeved on the base support rod 32, and the bottom of the locking mechanism 4 is supported on the upper surface of the base body 31; the lower part of the upper clamping assembly 1 is fixedly provided on one side surface of the locking mechanism 4, and the lower clamping assembly 2 is movably connected to the locking mechanism 4 and is located below the upper clamping assembly 1. The locking mechanism 4 adopts mechanical locking. When the lower clamping assembly 2 is closed, the locking mechanism 4 is closed and tightly hugs the base support rod 32, thereby restricting the lower clamping assembly 2 from opening.

[0033] Among them, the base support rod 32 has different structural forms such as a threaded rod, a disc string rod or a straight column rod.

[0034] The blocking member 5 is arranged at the center of the valve, thereby reducing central regurgitation, reducing leaflet stress and avoiding leaflet damage.

[0035] The upper clamping assembly 1 includes an elastic upper clamping plate 11 with shape memory function. At least one wire threading hole 12 is formed on the plate body of the elastic upper clamping plate 11. A rough structure 14 is provided on the surface of the elastic upper clamping plate 11 facing the lower clamping assembly 2. The rough structure includes a tooth-like structure, a barbed structure or a convex structure, which can be a single-tooth parallel arrangement or a double-tooth side-by-side arrangement. The rough structure 14 can also be a plurality of spaced flat-tooth structures vertically protruding outward from the back of the elastic upper clamping plate 11, rectangular sheets or rectangular teeth protruding outward from the outer side surface of the elastic upper clamping plate 11 and arranged side by side, and arranged at equal intervals; it can also be arranged with the interval gradually decreasing or increasing from one end to the other end. The rough structure 14 is a row of sawteeth or barbs obliquely formed from the two side edges of the plate body of the elastic upper clamping plate 11, or a row of sawteeth structure that is continuous on both sides as a whole.

[0036] In one embodiment, the rough structure 14 is a row of sawteeth or barbs obliquely formed from the two side edges of the plate body of the elastic upper clamping plate 11. The rough structure 14 is used to improve the clamping force on the target tissue during clamping and enhance the stability of the captured leaflet during the operation. The protrusions of the rough structure 14 can be successively lengthened, shortened, unchanged, etc. from bottom to top, or can be arranged with one long and one short at intervals.

[0037] Among them, the wire threading hole 12 is used for threading a wire to perform fine adjustment during the operation, etc.

[0038] The upper clamping assembly 1 includes an elastic upper clamping plate 11 and is arranged on one side of the locking mechanism 4, and a lower clamping assembly 2 is correspondingly arranged.

[0039] The upper clamping assembly 1 further includes an upper clamping connection bottom plate 13. An elastic upper clamping plate 11 is arranged at one end of the upper clamping connection bottom plate 13. The upper clamping connection bottom plate 13 and the elastic upper clamping plate 11 are integrally connected and have a concave structure. An upper clamping through hole 15 is formed in the middle of the upper clamping connection bottom plate 13. The upper surface of the upper clamping connection bottom plate 13 is attached to the bottom surface of the locking mechanism 4, and the inner side surface of the lower part of the elastic upper clamping plate 11 is attached to the outer side surface of the locking mechanism 4.

[0040] The elastic upper clamping plate 11 with shape memory function has a preset expansion angle α, and α = 30 - 135°, preferably 90°.

[0041] During working application, the elastic upper clamping plate 11 is pulled by an independent control wire to reach the expansion angle α to control the captured leaflet.

[0042] The lower clamping assembly 2 includes a lower clamping bottom plate 21 and lower clamping side plates 22 vertically arranged on both sides of the lower clamping bottom plate 21; a receiving cavity for cooperating with the upper clamping assembly 1 is formed by the lower clamping bottom plate 21 and the lower clamping side plates 22 on one side of the locking mechanism 4. The lower part of the lower clamping side plate 22 is connected to a hinge plate 23 and is movably connected to the locking mechanism 4.

[0043] The through hinge holes 24 formed in the hinge plate 23 are used for connecting the lower clamping assembly 2 and the locking mechanism 4. Linkage holes 25 are also formed in the hinge plate 23.

[0044] In the receiving cavity, protrusions in shapes other than limited to strip shapes can be provided to make the clamping more stable.

[0045] The shape of the base body 31 of the base 3 can be a hemispherical body, a spherical crown, a warhead shape, a symmetrically flattened tip shape, or other structures.

[0046] The locking mechanism 4 includes a locking seat 41. A hollow locking cavity is formed in the lower part of the locking seat 41. An inclined surface boss 42 protrudes into the cavity on one side wall of the locking cavity. The inclined surface boss 42 is used to fit with the base support rod 32 so that the locking mechanism 4 is positioned on the base 3. A coupling channel is vertically and throughly formed in the locking seat 41. The base support rod 32 of the base 3 is inserted into the coupling channel through the locking seat bottom plate hole 411 at the bottom of the locking seat 41.

[0047] Locking hinge holes 412 are formed on the adjacent side surfaces of the locking seat 41 and the side surface of the upper clamping assembly 1 for the hinge plate 23 of the lower clamping assembly 2 to be movably connected to the corresponding side surface of the locking seat 41.

[0048] When the base support rod 32 uses a disk string type rod, two inclined surface bosses 42 are relatively flushly arranged in the lower locking cavity of the locking seat 41, which can also be planar bosses, for fitting and positioning the disk string on the base support rod 32 so that the locking mechanism 4 is positioned on the base 3. The above-mentioned movable connection includes but is not limited to hinge, pivot connection and other methods.

[0049] The valve regurgitation blocking device further includes a link arm 6. The link arm 6 includes a link bottom plate 61 and link side plates 62 vertically arranged perpendicular to the side edges of the link bottom plate 61. The lower part of the link side plates 62 is movably connected to the base body 31 of the base 3, and the upper part of the link side plates 62 is movably connected to the linkage holes 25 of the lower clamping assembly 2, thereby forming a four-bar linkage mechanism, and the receiving groove formed by the link bottom plate 61 and the link side plates 62 is accommodated and matched with the lower outer contour of the lower clamping assembly 2.

[0050] The link arm 6 further includes a link hinge hole 63 formed in the lower part of the link side plates 62 and a link linkage hole 64 formed in the upper part of the link side plates 62.

[0051] The lower part of the link side plates 62 is movably connected to the two base connection holes 33 of the base 3 through the link hinge hole 63, such as hinge, pivot connection, etc.

[0052] The expanded state of the blocking net of the blocking member 5 is in the shape of a hazelnut, a cylinder, a quasi-cylinder, an ellipsoid, a cone, a gold ingot, a pillow, a horn, a saddle, a sphere, a flattened sphere or an irregular shape. The blocking net is connected to the lower clamping assembly 2 through the ends of the net.

[0053] When not in use or during transportation, the occlusive braid can be compressed into a smaller sheath. After it expands, its shape can be set into various flat or ellipsoidal states, as long as it can expand to play an occlusive role.

[0054] The occlusive braid can be woven from shape memory metal and heat-treated into a specific shape, and it has a radial supporting force for self-supporting.

[0055] Therefore, the occlusive braid provided in the center of the valve has two functions: ① reducing the regurgitation in the central region; ② reducing the damage to the valve leaflets during the valve closing process.

[0056] A biocompatible PET film is coated on the outer surfaces of the upper clamping assembly 1, the lower clamping assembly 2, the base 3, the locking mechanism 4, the connecting rod arm 6 and the blocking component 5.

[0057] In another embodiment ( Figure 6 ), the blocking component 5 is provided as a sheet-shaped biological tissue membrane, including a membrane tissue made of animal pericardium or animal heart valve. The membrane tissue is connected to one side of the lower clamping assembly 2 by suture. The membrane tissue is connected to the clamping component and then connected to one leaflet of the human body itself, so as to increase the area of the self-valve, thereby increasing the coaptation area of the valve and reducing the regurgitation of the valve.

[0058] The above is only the preferred embodiment of the present invention, and it does not limit the present invention in any formal or substantial way. It should be pointed out that for those of ordinary skill in the art in this technical field, without departing from the premise of the present invention, several improvements and supplements can still be made, and these improvements and supplements should also be regarded as the protection scope of the present invention. For those who are familiar with the technology in this field, without departing from the spirit and scope of the present invention, any equivalent changes made by using the technical content disclosed above, such as slight modifications, decorations and evolutions, are all equivalent embodiments of the present invention; at the same time, any equivalent changes made to the above embodiments according to the essential technology of the present invention, such as modifications, decorations and evolutions, still fall within the scope of the technical solution of the present invention.

Claims

1. A valve regurgitation blocking device, characterized in that: It includes a blocking component and a clamping component. The clamping component includes an upper clamping assembly, a lower clamping assembly, a base, a locking mechanism, and a connecting rod arm. A movable locking mechanism is sleeved on the base. Two openable and closable lower clamping assemblies are arranged on the outer periphery of the locking mechanism, and a connecting rod arm for opening the lower clamping assemblies through a connecting rod mechanism. Only one lower clamping assembly is provided with an openable and closable upper clamping assembly between it and the locking mechanism, and a blocking component is arranged on the other lower clamping assembly. A space for clamping the valve is provided between the upper clamping assembly and a corresponding lower clamping assembly. The blocking component is only arranged on the outer side of the other lower clamping assembly away from the locking mechanism. The blocking component is set as a structure woven by shape memory metal, including a structure formed by heat setting the weaving of nickel-titanium wires. The shape of the blocking component includes a cylindrical shape, a quasi-cylindrical shape, a flat spherical shape, a triangular shape, an elliptical spherical shape, a pot lid shape, a hemispherical shape, or a petal shape. The outer surface of the blocking component is covered with a film of polymer material. Or, the blocking component is set as a sheet-shaped biological tissue membrane, including a membrane tissue made of animal pericardium or animal heart valve. The outer surfaces of the upper clamping assembly, the lower clamping assembly, the base, the locking mechanism, the connecting rod arm, and the blocking component are coated with a biocompatible polymer coating film, and the blocking component is arranged at the center of the valve.

2. The valve regurgitation blocking device according to claim 1, wherein: The base includes a base body and a base support rod. One end of the base support rod close to the ventricle is vertically arranged on the base body.

3. The valve regurgitation blocking device according to claim 2, characterized in that: The locking mechanism is sleeved on the base support rod. The locking mechanism includes a locking seat movably connected to the base body. The locking seat is provided with a hollow cavity for passing through the base support rod. A limiting boss is arranged on the inner wall of the cavity. A connecting hole for connecting with the lower clamping assembly is arranged on the locking seat.

4. The valve regurgitation blocking device according to claim 2, wherein: The upper clamping assembly is sleeved on the base support rod. The upper clamping assembly includes an upper clamping connecting bottom plate and an elastic upper clamping plate with a shape memory function arranged at one end of the upper clamping connecting bottom plate. A through hole for passing through the base support rod is arranged on the upper clamping connecting bottom plate. The elastic upper clamping plate is arranged outside the locking mechanism. A rough structure for clamping the valve is arranged on the side of the elastic upper clamping plate away from the locking mechanism. The rough structure includes a toothed structure or a barbed structure. A threading hole is also arranged on the elastic upper clamping plate. A pulling wire for pulling the elastic upper clamping plate is arranged in the threading hole.

5. The valve regurgitation blocking device according to claim 4, characterized in that: The lower clamping assembly includes a lower clamping bottom plate and lower clamping side plates vertically arranged on both sides of the lower clamping bottom plate facing the locking mechanism. A cavity for clamping the valve is formed between the lower clamping bottom plate, the lower clamping side plates on both sides, and the elastic upper clamping plate. The lower clamping side plate extends towards the ventricle side and is provided with a hinge plate. A hinge hole movably connected to the locking seat is arranged on the hinge plate. A linkage hole movably connected to the connecting rod arm is also arranged on the hinge plate.

6. The valve regurgitation blocking device according to claim 5, characterized in that: The connecting rod arm is arranged below the lower clamping assembly and includes a connecting rod bottom plate and connecting rod side plates perpendicular to the connecting rod bottom plate on both sides of the connecting rod bottom plate facing the locking mechanism. One end of the connecting rod side plate close to the ventricle is movably connected to the base body, and one end of the connecting rod side plate away from the ventricle is movably connected to the hinge plate.

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