Mitral valve clipping device and mitral valve clipping system

Abstract

The application discloses a mitral valve clamping device, which is implanted through a heart apex, and comprises an upper clamping assembly and a lower clamping assembly. The upper clamping assembly comprises a flexible clamping sheet and a first supporting piece, and the first supporting piece is connected with a distal end of the flexible clamping sheet. The lower clamping assembly comprises a first clamping arm, a second clamping arm and a second supporting piece. One end of the first clamping arm and one end of the second clamping arm are rotatably connected to form a first connecting part, and the first connecting part is connected with the second supporting piece. The second supporting piece is connected with a proximal end of the flexible clamping sheet. The flexible clamping sheet can be in a straight state and a folded state. When the flexible clamping sheet is in the folded state, a first clamping surface and a second clamping surface can be formed. The first clamping surface cooperates with the first clamping arm, and the second clamping surface cooperates with the second clamping arm to jointly clamp the mitral valve. The application further provides a mitral valve clamping system comprising the above-mentioned mitral valve clamping device.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a mitral valve clamping device and a mitral valve clamping system. Background Technology

[0002] This section provides only background information relevant to this disclosure and is not necessarily prior art.

[0003] The mitral valve is a part of the heart located between the left atrium and the left ventricle. Blood is pumped from the left atrium into the left ventricle, and the mitral valve closes to prevent blood from being pumped back into the left atrium as the left ventricle contracts and pumps blood throughout the body. In some patients, whether due to a genetic malformation, disease, or injury, the mitral valve cannot close properly, resulting in a condition called regurgitation, in which blood is pumped into the atrium with each contraction of the heart muscle. Regurgitation is a serious condition that often worsens rapidly, reduces circulatory efficiency, and must be corrected.

[0004] Mitral regurgitation is one of the most common valvular diseases today. The main causes include mitral annular dilatation, chordae tendineae insufficiency, mitral myxomatosis, leaflet prolapse, rheumatic valvular heart disease, and ischemic lesions. Open-heart mitral valve repair and artificial valve replacement are the most effective treatments for mitral regurgitation. However, because these surgeries require cardiopulmonary bypass, they are quite invasive and carry a high risk of complications and mortality, especially in elderly patients and those with multiple comorbidities.

[0005] Therefore, in recent years, medical and research personnel in various countries have explored transapical mitral valve repair techniques, with the main interventional treatment being mitral valve clamping. The mitral valve clamp is a device that allows an implantable clamp to be inserted near the mitral valve through the apex of the heart, clamping and fixing the free edges of the anterior and posterior leaflets to ensure good leaflet apposition at the end of systole and reduce regurgitation. Summary of the Invention

[0006] Based on this, the present invention proposes a mitral valve clamping device, which is implanted through the apex of the heart to solve the regurgitation problem caused by mitral valve insufficiency.

[0007] To achieve this objective, the present invention adopts the following technical solution:

[0008] This invention provides a mitral valve clamping device, which is implanted via the apex of the heart. The mitral valve clamping device includes:

[0009] An upper clamping assembly, the upper clamping assembly including a flexible clamping piece and a first support member, the first support member being connected to the distal end of the flexible clamping piece;

[0010] The lower clamping assembly includes a first clamping arm, a second clamping arm, and a second support member. One end of the first clamping arm and one end of the second clamping arm are rotatably connected to form a first connecting part. The first connecting part is connected to the second support member, and the second support member is connected to the proximal end of the flexible clamping piece.

[0011] When the first support moves the flexible clamping piece proximally and closes to the second support, the flexible clamping piece is folded and forms a first clamping surface and a second clamping surface. The first clamping surface cooperates with the first clamping arm and the second clamping surface cooperates with the second clamping arm to clamp the mitral valve. When the first support moves the flexible clamping piece distally, the flexible clamping piece is straightened.

[0012] The mitral valve clamping device of the present invention is implanted in the left ventricle via the apex and can clamp the mitral valve. The flexible clamping plate of the upper clamping component of the mitral valve clamping device is in a straight state and can be inserted between the valves of the mitral valve. When the flexible clamping plate of the mitral valve clamping device is in a folded state, the first clamping surface cooperates with the first clamping arm, and the second clamping surface cooperates with the second clamping arm to jointly clamp the mitral valve.

[0013] In some embodiments of the mitral valve clamping device of the present invention, the mitral valve clamping device further includes:

[0014] A first drive assembly is connected to the proximal end of the lower clamping assembly. The first drive component includes a linkage assembly, which is connected to the first clamping arm, the second clamping arm, and the second support member, respectively.

[0015] The linkage assembly can drive the second support member to move to the far end or near end, so that the first clamping arm and the second clamping arm open or close relative to the upper clamping assembly.

[0016] In some embodiments of the mitral valve clamping device of the present invention

[0017] The first drive assembly further includes a first base, which is connected to the proximal end of the flexible clamping piece;

[0018] The first clamping arm is further provided with a second connecting part, and the second clamping arm is further provided with a third connecting part;

[0019] The linkage assembly also includes:

[0020] A first control lever, the distal end of which is connected to a second support member, and a first base having a cavity through which the first control lever passes;

[0021] A first link, one end of which is rotatably connected to the second connecting part, the first link supporting the first clamping arm to rotate around the first connecting part;

[0022] The second link has one end rotatably connected to the third connecting part, and the second link supports the second clamping arm to rotate around the first connecting part.

[0023] In some embodiments of the mitral valve clamping device of the present invention, a locking structure is provided in the first base, the locking structure being used to clamp the first control rod to prevent relative movement between the first control rod and the first base.

[0024] In some embodiments of the mitral valve clamping device of the present invention, adjacent mounting grooves and a portion of an inverted conical cavity are sequentially arranged along the axial direction in the cavity of the first base. The locking structure includes a clamping member, which is sleeved on the first control rod. The clamping member is provided with an elastic part that can extend and retract axially and the elastic part is disposed in the mounting groove. The clamping member is provided with an extension end from the distal end to the proximal end.

[0025] Under the elastic force provided by the elastic part in the mounting groove, the proximal outer side of the protruding end abuts against the wall of the central region of the inverted conical cavity, and the proximal inner side of the protruding end can squeeze the first control rod.

[0026] In some embodiments of the mitral valve clamping device of the present invention, the distal end of the clamping member is provided with a flange, the flange is sleeved on the outside of the first control rod, the upper end face of the elastic part is connected to the flange, and the lower end face of the elastic part abuts against the axial end face of the mounting groove, or

[0027] The lower end face of the elastic part is connected to the flange, and the upper end face of the elastic part abuts against the axial end face of the mounting groove.

[0028] In some embodiments of the mitral valve clamping device of the present invention, the clamping member is provided with at least two protruding ends, and the protruding ends are equally spaced along the circumference of the first control rod.

[0029] In some embodiments of the mitral valve clamping device of the present invention, the first driving assembly further includes a first traction member, the distal end of the first traction member being connected to the distal end of the clamping member, and the elastic portion being axially extendable and retractable under the action of the first traction member.

[0030] In a second aspect, the present invention also provides a mitral valve clamping system for capturing and clamping the mitral valve in the left ventricle, the mitral valve clamping system comprising the mitral valve clamping device as described in any of the preceding claims.

[0031] The mitral valve clamping system also includes:

[0032] A catheter, the distal end of which is connected to the mitral valve clamping device;

[0033] An operating handle is connected to the proximal end of the catheter.

[0034] In some embodiments of the mitral valve clamping system of the present invention, the mitral valve clamping system further includes a second control rod disposed within the catheter, the distal end of the second control rod being threadedly connected to the proximal end of the first control rod.

[0035] In some embodiments of the mitral valve clamping system of the present invention, the catheter is provided with a guide at the side end of the mitral valve clamping device, the distal extension length of the guide is adapted to the valve length of the mitral valve, and the distal end of the guide is provided with a guide ring.

[0036] In some embodiments of the mitral valve clamping system of the present invention, the mitral valve clamping system further includes a second traction member, which passes sequentially through a first through hole in the first support member and the guide ring, and extends to the operating handle through the conduit.

[0037] In some embodiments of the mitral valve clamping system of the present invention, the distal end of the catheter is provided with a connecting rod, and the connecting end face of the connecting rod and the proximal end of the first base is S-shaped in the axial direction. Attached Figure Description

[0038] Figure 1 It shows an anatomical diagram of the human heart;

[0039] Figure 2a This illustrates the good mitral valve occlusion state of the human heart;

[0040] Figure 2b This illustrates the state where the mitral valves of the human heart cannot fully align.

[0041] Figure 3 This illustration shows one embodiment of the mitral valve clamping device of the present invention applied to a mitral valve clamping system;

[0042] Figure 4 This illustration shows one embodiment of the mitral valve clamping device of the present invention applied to a mitral valve clamping system;

[0043] Figure 5 The diagram illustrates the retracted state of the first and second clamping arms of the mitral valve clamping device of the present invention.

[0044] Figure 6aA top view of the mitral valve clamping device of the present invention is shown, wherein the first clamping arm and the second clamping arm are in a retracted state.

[0045] Figure 6b for Figure 6a AA section view;

[0046] Figure 7 This illustration shows one embodiment of the locking structure of the mitral valve clamping device of the present invention;

[0047] Figure 8 The diagram illustrates the clamping component of the mitral valve clamping device of the present invention;

[0048] Figure 9 The connection relationship between the mitral valve clamping device and the mitral valve clamping system of the present invention is illustrated.

[0049] Figure 10 The diagram illustrates the linkage assembly in the mitral valve clamping device of the present invention, wherein the clamping assembly is in an open state under the drive of the linkage assembly.

[0050] Figure 11 The linkage assembly of the mitral valve clamping device of the present invention is illustrated, wherein the clamping assembly is in a retracted state under the drive of the linkage assembly;

[0051] Figure 12 The diagram illustrates that the flexible clamping piece of the mitral valve clamping device of the present invention is in a folded state;

[0052] Figure 13 This illustration shows one embodiment of the first drive assembly of the mitral valve clamping device of the present invention;

[0053] Figure 14 This diagram illustrates the structure of the mitral valve clamping device of the present invention installed in a mitral valve clamping system.

[0054] Figure 15 The diagram illustrates an isometric view of the mitral valve clamping system of the present invention.

[0055] Figure 16 This diagram illustrates the state of the mitral valve clamping system of the present invention in the left ventricle near the mitral valve.

[0056] Figure 17 This diagram illustrates the state of the mitral valve clamping system of the present invention capturing the mitral valve in the left ventricle;

[0057] Figure 18 This diagram illustrates the state of the mitral valve clamping device clamping the mitral valve in the mitral valve clamping system of the present invention.

[0058] The attached figures are labeled as follows:

[0059] 100 mitral valve clamping device,

[0060] 110 Upper clamping assembly, 111 Flexible clamping piece, 112 First clamping surface, 113 Second clamping surface, 114 First support member, 115 First through hole, 116 Barb structure;

[0061] 120 Lower clamping assembly, 121 First clamping arm, 122 Second connecting part, 123 Second clamping arm, 124 Third connecting part, 125 Second support member, 126 First connecting part;

[0062] 130 First drive assembly, 131 First base, 132 Mounting slot, 133 Inverted conical cavity;

[0063] 140 Linkage assembly, 141 First control lever, 142 First link, 143 Second link;

[0064] 150 Locking structure, 151 Clamping element, 152 Elastic part, 153 Extended end, 154 Flange, 155 Proximal outer surface of the extended end, 156 Proximal inner surface of the extended end;

[0065] 160 First traction component;

[0066] 200 Mitral valve clamping system, 210 Catheter, 220 Operating handle, 230 Second control lever, 240 Guide element, 250 Guide ring;

[0067] 260 Second traction component, 270 Connecting rod, 271 "S" type connecting end face;

[0068] LA (left atrium), LV (left ventricle), MV (mitral valve), LF (left lateral valve). Detailed Implementation

[0069] To make the objectives, technical solutions, and advantages of this invention clearer, exemplary embodiments of this disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of this disclosure are shown in the drawings, it should be understood that this disclosure can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of this disclosure and to fully convey the scope of this disclosure to those skilled in the art.

[0070] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0071] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0072] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0073] Additionally, it should be noted that in the field of interventional medical devices, the end of a medical device implanted in the human or animal body, or the delivery system that delivers the medical device, closer to the operator is generally referred to as the "proximal end," and the end farther from the operator is referred to as the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device or delivery system are defined. "Axial direction" generally refers to the length direction of the medical device during delivery, and "radial direction" generally refers to the direction of the medical device perpendicular to its "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined.

[0074] This invention provides a mitral valve clamping device, which is implanted transapically and can clamp the mitral valve in the left ventricle. The mitral valve clamping device includes an upper clamping component and a lower clamping component, which cooperate to capture and clamp the mitral valve.

[0075] The upper clamping assembly includes a flexible clamping piece and a first support member. The distal end of the flexible clamping piece is connected to the first support member. The first support member drives the flexible clamping piece to move to the distal end, so that the flexible clamping piece is in a straight state. The first support member drives the flexible clamping piece to move to the proximal end, so that the flexible clamping piece is in a folded state.

[0076] The folded flexible clamping pieces are respectively above the first clamping arm and the second clamping arm, forming two layers of flexible clamping pieces by folding in half, wherein the fold line is located on the outside of the flexible clamping pieces;

[0077] When attempting to capture the valve, the flexible clamping piece is in a vertical position, at which point the length of the flexible clamping piece reaches its maximum and the contact area with the valve is also large. At this time, the first support member drives the flexible clamping piece to move and fold, which can efficiently complete the capture of the valve.

[0078] The lower clamping assembly includes a first clamping arm and a second clamping arm. One end of the first clamping arm and one end of the second clamping arm are rotatably connected. When the first clamping arm and the second clamping arm are open, the first clamping arm and the first clamping arm cooperate with the flexible clamping plate to capture the mitral valve in the left ventricle. When the first clamping arm and the second clamping arm are closed, the flexible clamping plate, together with the first clamping arm and the second clamping arm, clamps the mitral valve and closes the mitral valve.

[0079] The lower clamping assembly also includes a second support member, which is connected to the proximal end of the flexible clamping piece. When the first clamping member moves the flexible clamping piece proximal to the second support member, the flexible clamping piece is folded and forms a first clamping surface and a second clamping surface. The first clamping surface and the first clamping arm cooperate to clamp one mitral valve membrane, and the second clamping surface and the second clamping arm cooperate to clamp the other mitral valve membrane. Thus, the first clamping surface and the second clamping surface of the flexible clamping piece cooperate with the first clamping arm and the second clamping arm of the lower clamping assembly to jointly clamp the mitral valve.

[0080] During mitral valve surgery, the mitral valve clamping device provided by this invention is placed within a mitral valve clamping system. The mitral valve clamping system is implanted in the left ventricle near the mitral valve and transapical. An operating handle is located at the proximal end of the mitral valve clamping system. The operator can use the operating handle to first move the first support member distally, causing the flexible clamping plate to move distally with the first clamping member and straighten until it extends between the two mitral valves. Simultaneously, the first and second clamping arms of the lower clamping assembly open, gradually approaching the mitral valve in the left ventricle. Mitral valve; when the flexible clamping plate can capture the mitral valve membrane, the operator operates the handle to move the first support of the upper clamping assembly proximally. As the first support moves proximally, the flexible clamping plate gradually folds, and the first and second clamping arms of the lower clamping assembly gradually close, so that the first clamping arm and the first clamping surface of the flexible clamping plate cooperate to clamp one mitral valve membrane, and the second clamping arm and the second clamping surface of the flexible clamping plate cooperate to clamp the other mitral valve membrane. When the first and second clamping arms are fully closed, the mitral valve is clamped and closed.

[0081] The mitral valve clamping system includes a first driving component and a locking structure. The first driving component drives the upper clamping component and the lower clamping component of the mitral valve clamping device. Specifically, the first driving component drives the first support member to move the flexible clamping piece to the distal or proximal end, and the first driving component drives the first clamping arm and the second clamping arm of the lower clamping component to open or close. When the first clamping arm and the second clamping arm are fully closed, the locking structure can fix the closed first clamping arm and the second clamping arm to keep them in a locked state.

[0082] The mitral valve clamping system includes a guide component that engages with the flexible clamping plate in the extended state of the mitral valve clamping device to precisely capture the mitral valve membrane.

[0083] In one embodiment, the first driving component and locking structure described above can be disposed in the mitral valve clamping device. After the mitral valve clamping system completes clamping and fixing the mitral valve, the other components in the mitral valve clamping system are separated from the mitral valve clamping device and withdrawn from the left ventricle.

[0084] The mitral valve clamping device of the present invention and its operation in a mitral valve clamping system will be described below with reference to the accompanying drawings.

[0085] Figure 1 This diagram illustrates the anatomical structure of the human heart, where LA represents the left atrium, LV represents the left ventricle, and the mitral valve MV is located between the left atrium and the left ventricle. The mitral valve MV has two valves LF. Blood is pumped from the left atrium into the left ventricle LV through LA. When the left ventricle LV contracts and pumps blood into the whole body, the mitral valve MV closes to prevent blood from being pumped back into the left atrium. Figure 2a This illustrates the proper mitral valve occlusion in the human heart. Figure 2b This illustrates the state where the mitral valves of the human heart cannot fully align.

[0086] Figure 3 This illustration depicts one embodiment of the mitral valve clamping device of the present invention applied to a mitral valve clamping system, wherein the flexible clamping piece is in a folded state; as shown... Figure 3 As shown, the mitral valve clamping device of the present invention includes an upper clamping assembly and a lower clamping assembly. In the upper clamping assembly 110, the distal end of the flexible clamping piece 111 is connected to the first support member 114. In the lower clamping assembly 120, the first clamping arm 121 and the second clamping arm 122 are rotatably connected. The flexible clamping piece 111 is in a folded state, which can form a first clamping surface 112 and a second clamping surface 113. The first clamping surface 112 cooperates with the first clamping arm 121 to clamp one mitral valve membrane, and the second clamping surface 113 and the second clamping arm 122 cooperate to clamp the other mitral valve membrane.

[0087] Figure 4 This illustration shows one embodiment of the mitral valve clamping device of the present invention applied to a mitral valve clamping system, wherein the flexible clamping piece is in a straightened state; as shown Figure 4 As shown, when the first support moves to the distal end, the flexible clamping piece is in a straight state. A guide is provided on the side end of the mitral valve clamping device. The proximal end of the guide is connected to the catheter of the mitral valve clamping system. The extension length of the guide to the distal end is adapted to the valve length of the mitral valve. The guide and the flexible clamping piece can precisely extend together between the two valves of the mitral valve.

[0088] Since the surgery is performed while the heart is still beating, the mitral valve clamping device needs to accurately capture and clamp the valve during the opening or closing of the mitral valve. The guide provided by this invention can help the operator to effectively and accurately locate the valve from the apex of the heart, thereby efficiently capturing the valve leaflets.

[0089] like Figure 4The flexible clamping sheet is further provided with a barb structure for capturing and fixing the mitral valve membrane. The barb structure is formed on the first clamping surface and the second clamping surface of the flexible clamping sheet when it is in a folded state.

[0090] like Figure 3 and Figure 4 As shown, the first and second clamping arms of the lower clamping assembly are in the open state, combined with... Figure 16 and Figure 17 As can be seen, the mitral valve clamping device of the present invention is disposed in the mitral valve clamping system. When the first clamping arm and the second clamping arm of the mitral valve clamping device are in the open state and the flexible clamping piece is in the straight state, the guide and the flexible clamping piece can extend together precisely between the mitral valves.

[0091] Specifically, the process by which the first support member moves the flexible clamping piece to the distal end, bringing the flexible clamping piece into an extended state, is as follows:

[0092] The first support member of the mitral valve clamping device of the present invention is provided with a first through hole, and the catheter of the mitral valve clamping system is provided with a guide member. The guide member is provided at the side end of the mitral valve clamping device. Preferably, the first guide member and the second guide member are symmetrically arranged on both sides of the mitral valve clamping device. The distal extension length of the guide member or the first guide member or the second guide member is adapted to the valve length of the mitral valve. The distal end of the guide member or the first guide member is provided with a first guide ring, or the distal end of the second guide member is provided with a second guide ring. The mitral valve clamping device is also provided with a second traction member. The second traction member passes through the first through hole, the first guide ring, and the second guide ring in sequence. The two ends of the first flexible connector extend to the operating handle through the catheter.

[0093] The operator continuously pulls both ends of the first flexible connector in the operating handle of the mitral valve clamping system. The first flexible connector pulls the first support member to move to the distal end through the first through hole, thereby causing the flexible clamping piece to move to the distal end with the first support member and gradually straighten.

[0094] Figure 5 The diagram illustrates the retracted state of the first and second clamping arms of the mitral valve clamping device of the present invention, as shown below. Figure 5 As shown, the flexible clamping piece is folded and retracted between the first clamping arm and the second clamping arm, thus combining... Figure 18 As can be seen, when the first clamping arm and the second clamping arm are in the fully retracted state, the first clamping surface of the flexible clamping piece cooperates with the first clamping arm to clamp one valve of the mitral valve, and the second clamping surface of the flexible clamping piece cooperates with the second clamping arm to clamp the other valve of the mitral valve, so that the mitral valve clamping device clamps the mitral valve.

[0095] Figure 6aThe diagram illustrates a top view of the mitral valve clamping device of the present invention, wherein the first clamping arm and the second clamping arm are in a retracted state. Figure 6b for Figure 6a AA sectional view; such as Figure 6a and Figure 6b As shown, the mitral valve clamping device of the present invention includes an upper clamping assembly and a lower clamping assembly. In the upper clamping assembly, the distal end of the flexible clamping piece is connected to a first support member, and the proximal end of the flexible clamping piece is connected to a second support member. The second support member is also connected to a first connecting portion, which is formed by rotatably connecting one end of a first clamping arm and one end of a second clamping arm.

[0096] The mitral valve clamping device also includes a first driving assembly, which includes a first base. The distal end of the flexible clamping piece can also be connected to the first base, which can better fix the flexible clamping piece at the proximal end.

[0097] Figure 10 The diagram illustrates the linkage assembly in the mitral valve clamping device of the present invention, wherein the clamping assembly is in an open state under the drive of the linkage assembly, as shown in the diagram. Figure 10 As shown, the first driving assembly of the mitral valve clamping device of the present invention includes a first base and a connecting rod assembly, wherein the connecting rod assembly further includes a first control rod, a first connecting rod and a second connecting rod. The distal end of the first control rod is connected to the second support member, and the proximal end of the first control rod is connected to the catheter in the mitral valve clamping system. By controlling the operating handle of the mitral valve clamping system, the first control rod can drive the second support member to move to the distal or proximal end.

[0098] The first link is used to support the first clamping arm to rotate around the first connecting part. Specifically, the first clamping arm is provided with a second connecting part, one end of the first link is rotatably connected to the second connecting part, and the other end of the first link is rotatably connected to the first base.

[0099] The second link is used to support the second clamping arm to rotate around the first connecting part. Specifically, the second clamping arm is provided with a third connecting part, one end of the second link is rotatably connected to the third connecting part, and the other end of the second link is rotatably connected to the first base.

[0100] It should be noted that the rotatable connection between one end of the first connecting rod and the second connecting part, and the rotatable connection between the other end of the first connecting rod and the first base, can be arranged according to specific circumstances. For example, they can be hinged, a rotating shaft can be set in the second connecting part or the first base, and a bearing or bushing can be set on the first connecting rod. The bearing or bushing can cooperate with the rotating shaft to rotate. Similarly, a rotating shaft can be set on the first connecting rod, and a bearing or bushing can be set in the second connecting part or the first base.

[0101] It should be noted that the rotatable connection between one end of the second connecting rod and the third connecting part, and the rotatable connection between the other end of the second connecting rod and the first base, can be arranged according to specific circumstances. For example, they can be hinged; a rotating shaft can be set in the third connecting part or the first base, and a bearing or bushing can be set on the second connecting rod. The bearing or bushing can cooperate with the rotating shaft to rotate. Similarly, a rotating shaft can be set on the second connecting rod, and a bearing or bushing can be set in the third connecting part or the first base.

[0102] As can be seen from the above embodiments, in the mitral valve clamping device provided by the present invention, the linkage assembly in the first driving assembly is connected to the first clamping arm, the second clamping arm and the second support member respectively. The second linkage assembly can drive the second support member to move to the distal end so that the first clamping arm and the second clamping arm open relative to the upper clamping assembly. The second linkage assembly can drive the second support member to move to the proximal end so that the first clamping arm and the second clamping arm close relative to the upper clamping assembly.

[0103] The present invention provides the above-described preferred embodiments. In practical applications, the linkage assembly can be specifically arranged according to the technical teachings provided by the present invention to realize the opening or closing of the first clamping arm and the second clamping arm relative to the upper clamping assembly.

[0104] It should be understood that the first drive assembly or the linkage assembly in the first drive assembly can be used as part of the mitral valve clamping device or can be set in the mitral valve clamping system to connect the first drive component or the linkage assembly to the mitral valve clamping device before capturing and clamping the mitral valve.

[0105] Figure 11 The diagram illustrates the linkage assembly of the mitral valve clamping device of the present invention, wherein the clamping assembly is in a retracted state under the drive of the linkage assembly, as shown in the diagram. Figure 11 As shown, the mitral valve clamping device is installed in the mitral valve clamping system. By operating the handle at the proximal end of the mitral valve clamping system, the components in the linkage assembly can be rotated relative to each other, and the first clamping arm and the second clamping arm can be supported to rotate around the first connecting part. Finally, the first clamping arm and the second clamping arm are in a fully retracted state.

[0106] In one embodiment of the present invention, in the mitral valve clamping device, a locking structure is provided in the first base. The locking structure is used to clamp the first control rod in the linkage assembly to prevent relative movement between the first control rod and the first base or the lower clamping assembly. The locking structure can clamp the first control rod under normal conditions. When it is necessary to move the first control rod, the locking structure can be released to allow the first control rod to move freely to the proximal or distal end.

[0107] In another embodiment of the present invention, the locking structure can also clamp the first control member after the upper clamping component and the lower clamping component capture and clamp the mitral valve to prevent the first control member from moving relative to the first base or the lower clamping component, thereby preventing the possibility of the lower clamping component and the upper clamping component becoming loose.

[0108] In one embodiment of the present invention, such as Figure 6b As shown, in the mitral valve clamping device, the first driving assembly includes a first base and a first control rod. The first base has a cavity for the first control rod to pass through. The distal end of the first control rod is connected to a second support member. A locking structure is also provided in the first base. The locking structure is used to clamp the first control rod and can prevent the first control rod from moving axially relative to the first base or the lower clamping assembly. In this embodiment, when the first control rod drives the second support member to fully retract the first clamping arm and the second clamping arm, the locking structure fixes the first control rod relative to the first base or the lower clamping assembly to prevent the first control rod from driving the lower clamping assembly to move, thereby also preventing further relative rotation of the first clamping arm and the second clamping arm, making the clamping device clamp the mitral valve more firmly. In this embodiment, the mitral valve clamping device is further provided with a locking structure. When the clamping device captures and clamps the mitral valve, it ensures that the mitral valve clamping device can reliably clamp and prevent loosening.

[0109] In another embodiment of the invention, such as Figure 6b and Figure 7 As shown, in the mitral valve clamping device, an installation groove and a partial inverted conical cavity are provided in the cavity of the first base. The installation groove and the inverted conical cavity are arranged adjacent to each other. Along the axial direction of the first base, the installation groove is arranged on the distal side and the inverted conical cavity is arranged on the proximal side.

[0110] The locking structure also includes a clamping member, which has an axially telescopic elastic portion and an extended end extending from the distal end to the proximal end. The clamping member is sleeved on the first control rod. The elastic portion is disposed in the mounting groove of the first base and can provide axial elastic force. The extended end is at least partially located in the inverted conical cavity. Under the action of the elastic force of the elastic portion, the proximal outer surface of the extended end abuts against the wall of the central region of the inverted conical cavity, and the proximal inner surface of the extended end can squeeze the first control rod.

[0111] When the first control lever is pushed towards the distal end, the inner surface of the proximal end of the extended end clamps the first control lever, and the outer surface of the proximal end of the extended end abuts against the wall of the inverted conical cavity. Furthermore, the inner diameter of the inverted conical cavity gradually narrows from the proximal end to the distal end. Therefore, under the pressure of the wall of the inverted conical cavity of the first base and the first control lever, the clamping member is prevented from moving towards the distal end. At the same time, the inner surface of the proximal end of the extended end clamps the first control lever, which also prevents the first control lever from moving towards the distal end. However, when the first control lever is moved towards the proximal end, since the inner diameter of the inverted conical cavity gradually increases from the distal end to the proximal end, there is an effective space for the proximal end of the extended end to move outward within the inverted conical cavity. Therefore, the inner surface of the proximal end of the extended end no longer presses against the first control lever, thereby allowing the first control lever to move towards the proximal end.

[0112] In the above embodiments, the locking structure can prevent the first control member from moving relative to the first base by clamping the first control member. In the mitral valve clamping device, after the upper clamping component and the lower clamping component capture and clamp the mitral valve, due to the action of the locking structure, the first control member no longer has the possibility of moving further in the proximal or distal direction, thereby ensuring that the clamping device can stably clamp the mitral valve.

[0113] In one embodiment of the mitral valve clamping device of the present invention, the distal end of the clamping member is provided with a flange sleeved on the first control rod, the upper end face of the elastic part of the clamping member is connected to the flange, and the lower end face of the elastic part is connected to the axial end face of the mounting groove; under the compression of the flange and the axial end face of the mounting groove, the elastic part is in an axially compressed state to provide elastic force, so that the proximal outer side of the protruding end of the clamping member abuts against the wall surface of the middle region of the inverted conical cavity, and the proximal inner side of the protruding end can compress the first control rod.

[0114] In one embodiment of the mitral valve clamping device of the present invention, unlike the above embodiment, the lower end face of the elastic part is connected to the flange, the upper end face of the elastic part is connected to the axial upper end face of the mounting groove, and the elastic part is in an axially stretched state to provide elastic force. Similarly, the proximal outer side of the protruding end of the clamping member can abut against the wall of the middle region of the inverted conical cavity, and the proximal inner side of the protruding end can squeeze the first control rod.

[0115] It should be noted that in the above two embodiments, the elastic part of the clamping member can provide elastic force whether it is in a compressed state or a stretched state in the mounting groove. Relative to the first control rod, this elastic force is an axial traction force from the proximal end to the distal end, so that the protruding end of the clamping member can squeeze the inner wall of the inverted conical cavity on the outside of the protruding end and squeeze the first control member on the inside of the protruding end, thereby realizing the locking of the mitral valve clamping device.

[0116] In one embodiment of the mitral valve clamping device of the present invention, when the clamping member and the flange are two independent components, the flange can be fixedly connected to the first control rod. In this connection method, the first control rod can drive the flange to move axially from the distal end to the proximal end under the condition of overcoming the elastic force of the elastic part.

[0117] In another embodiment of the mitral valve clamping device of the present invention, the flange, as part of the clamping member, is sleeved on the first control rod. When the first control rod moves axially, it is necessary to release the clamping force of the protruding end of the clamping member on the first control member. Therefore, in this embodiment, the mitral valve clamping device is also provided with a first traction member. The distal end of the first traction member is connected to the flange of the clamping member, or the distal end of the first traction member is connected to the distal end of the protruding end of the clamping member. The proximal end of the first traction member extends toward the operating handle. By traction of the first traction member, the elastic force provided by the elastic part of the clamping member can be overcome, so as to release the squeezing or clamping of the protruding end of the clamping member on the first control member, so that the first control member can move to the distal end.

[0118] In one embodiment of the mitral valve clamping device of the present invention, two protruding ends of the clamping member are provided, and the two protruding ends can be symmetrically arranged on both sides of the first control rod, so as to better clamp the first control member.

[0119] In one embodiment of the mitral valve clamping device of the present invention, such as Figure 7 and Figure 8 As shown, the clamping member has three protruding ends, which are evenly spaced along the circumference of the first control rod. In this embodiment, the protruding ends can clamp the first control rod in three directions, thereby better preventing the first control rod from moving.

[0120] In the two embodiments described above, the clamping member provides clamping force in two or three directions to the first control rod. Compared with a single contact point and a single direction of locking force, the locking structure in the mitral valve clamping device of the present invention will not have the risk of falling off due to incomplete closure or opening.

[0121] In the mitral valve clamping device provided by the present invention, the flexible clamping piece can be made of nickel-titanium alloy material. When the elastic part in the clamping member is set as a spring, the spring can be made of stainless steel or nickel-titanium alloy material. The biocompatible nickel-titanium alloy material or stainless steel material can better integrate with human tissue.

[0122] The present invention also provides a mitral valve clamping system, see reference. Figures 15 to 18 The mitral valve clamping system can be used to deliver the mitral valve clamping device to the vicinity of the mitral valve in the left ventricle. By operating the operating handle of the mitral valve clamping system, the mitral valve clamping device can capture and clamp the mitral valve. Furthermore, by setting a locking structure, the mitral valve clamping device can be prevented from loosening.

[0123] In one embodiment of the mitral valve clamping system provided by the present invention, the mitral valve clamping system includes a mitral valve clamping device as described in any of the preceding claims, and further includes a catheter and an operating handle, wherein the distal end of the catheter is connected to the proximal end of the mitral valve clamping device, and more specifically, the distal end of the catheter may be connected to the proximal end of the first base of the mitral valve clamping device; the proximal end of the catheter is connected to the operating handle, and by controlling the operating handle, the mitral valve clamping device captures and clamps the mitral valve.

[0124] In one embodiment of the mitral valve clamping system provided by the present invention, a guide structure is also provided. Specifically, a guide member is provided at the distal end of the catheter. The guide member is located at the side end of the mitral valve clamping device. A guide ring is provided at the distal end of the guide member. The extension length of the guide member to the distal end is adapted to the valve length of the mitral valve. With the help of the guide structure, the first support member of the clamping device can be moved to the distal end, while the flexible clamping piece is in a straightened state.

[0125] In a more preferred embodiment, guide members are provided opposite to each other at the distal end of the catheter, the opposite guide members are arranged on both sides of the mitral valve clamping device, and guide rings are provided at the distal ends of the opposite guide members.

[0126] In one embodiment of the mitral valve clamping system provided by the present invention, a second traction member is further included. The second traction member passes sequentially through the guide ring of a guide member, the through hole of a first support member, and the guide ring of another guide member, and extends to the operating handle through a catheter. In this embodiment, a first through hole is also provided on the first support member of the mitral valve clamping device for the second traction member to pass through and pull the first support member to move distally.

[0127] In one embodiment of the mitral valve clamping system provided by the present invention, a connecting rod is provided at the distal end of the catheter, and the connecting rod is connected to the proximal end of the first base. The connecting end face can be configured to be curved. Preferably, the connecting end face is S-shaped in the axial direction. The connecting rod and the proximal end of the first base are connected with a curved cross-section to prevent loosening of the connection.

[0128] In one embodiment of the mitral valve clamping system provided by the present invention, a second control rod is provided inside the catheter, and the second control rod is threadedly connected to the first control rod; after the mitral valve clamping device completes the capture and clamping of the mitral valve, the first control rod and the second control rod can be separated more easily.

[0129] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A mitral valve clamping device, characterized in that, The mitral valve clamping device includes: An upper clamping assembly, the upper clamping assembly including a flexible clamping piece and a first support member, the first support member being connected to the distal end of the flexible clamping piece; The lower clamping assembly includes a first clamping arm, a second clamping arm, and a second support member. One end of the first clamping arm and one end of the second clamping arm are rotatably connected to form a first connecting part. The first connecting part is connected to the second support member, and the second support member is connected to the proximal end of the flexible clamping piece. A first drive assembly includes a linkage assembly and a first base, the first base being connected to the proximal end of the flexible clamping piece; the linkage assembly includes a first control rod, the distal end of the first control rod being connected to a second support member; the first base has a cavity for the first control rod to pass through, and a locking structure is provided inside the first base; adjacent mounting slots and a portion of an inverted conical cavity are sequentially provided along the axial direction in the cavity; the locking structure includes a clamping member, the clamping member being sleeved on the first control rod; the clamping member has an axially extendable elastic portion and the elastic portion is disposed within the mounting slot; the clamping member has an extension end from the distal end to the proximal end to prevent relative movement between the first control rod and the first base; Under the elastic force provided by the elastic part in the mounting groove, the proximal outer side of the protruding end abuts against the wall of the central region of the inverted conical cavity, and the proximal inner side of the protruding end can squeeze the first control rod. When the first support moves the flexible clamping piece proximally and closes to the second support, the flexible clamping piece is folded and forms a first clamping surface and a second clamping surface. The first clamping surface cooperates with the first clamping arm and the second clamping surface cooperates with the second clamping arm to clamp the mitral valve. When the first support moves the flexible clamping piece distally, the flexible clamping piece is straightened.

2. The mitral valve clamping device according to claim 1, characterized in that, The connecting rod assembly is connected to the first clamping arm, the second clamping arm, and the second support member, respectively. The linkage assembly can drive the second support member to move to the far end or near end, so that the first clamping arm and the second clamping arm open or close relative to the upper clamping assembly.

3. The mitral valve clamping device according to claim 2, characterized in that, The first clamping arm is further provided with a second connecting part, and the second clamping arm is further provided with a third connecting part; The linkage assembly also includes: A first link, one end of which is rotatably connected to the second connecting part, the first link supporting the first clamping arm to rotate around the first connecting part; The second link has one end rotatably connected to the third connecting part, and the second link supports the second clamping arm to rotate around the first connecting part.

4. The mitral valve clamping device according to claim 1, characterized in that, The distal end of the clamping member is provided with a flange, which is sleeved on the outside of the first control rod. The upper end face of the elastic part is connected to the flange, and the lower end face of the elastic part abuts against the axial end face of the mounting groove. The lower end face of the elastic part is connected to the flange, and the upper end face of the elastic part abuts against the axial end face of the mounting groove.

5. The mitral valve clamping device according to claim 4, characterized in that, The clamping member is provided with at least two protruding ends, and the protruding ends are equally spaced along the circumference of the first control rod.

6. The mitral valve clamping device according to any one of claims 1-5, characterized in that, The first drive assembly further includes a first traction member, the distal end of which is connected to the distal end of the clamping member. Under the action of the first traction member, the elastic part can extend and retract axially.

7. A mitral valve clamping system, characterized in that, The mitral valve clamping system is used to capture and clamp the mitral valve in the left ventricle, and the mitral valve clamping system includes the mitral valve clamping device according to any one of claims 1-6; The mitral valve clamping system also includes: A catheter, the distal end of which is connected to the mitral valve clamping device; An operating handle is connected to the proximal end of the catheter.

8. The mitral valve clamping system according to claim 7, characterized in that, The mitral valve clamping system also includes a second control rod disposed inside the catheter, the distal end of the second control rod being threadedly connected to the proximal end of the first control rod.

9. The mitral valve clamping system according to claim 7, characterized in that, The catheter is provided with a guide at the side end of the mitral valve clamping device. The distal extension length of the guide is adapted to the valve length of the mitral valve, and the distal end of the guide is provided with a guide ring.

10. The mitral valve clamping system according to claim 9, characterized in that, The mitral valve clamping system also includes a second traction member, which passes sequentially through the first through hole of the first support member and the guide ring, and extends to the operating handle through the conduit.

11. The mitral valve clamping system according to claim 7, characterized in that, The distal end of the conduit is provided with a connecting rod, and the connecting end face of the connecting rod and the proximal end of the first base is S-shaped in the axial direction.

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