WO2024067686A1 - Mitral valve clamping device and mitral valve clamping system - Google Patents

Abstract

Disclosed in the present application is a mitral valve clamping device (100). The mitral valve clamping device (100) is implanted through a cardiac apex. The mitral valve clamping device (100) comprises an upper clamping assembly (110) and a lower clamping assembly (120). The upper clamping assembly (110) comprises a flexible clamping piece (111) and a first supporting member (114). The first supporting member (114) is connected to the distal end of the flexible clamping piece (111). The lower clamping assembly (120) comprises a first clamping arm (121), a second clamping arm (123), and a second supporting member (125). One end of the first clamping arm (121) and one end of the second clamping arm (123) are rotatably connected to form a first connecting portion (126). The first connecting portion (126) is connected to the second supporting member (125). The second supporting member (125) is connected to the proximal end of the flexible clamping piece (111). When in a folded state, the flexible clamping piece (111) 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), and the second clamping surface (113) cooperates with the second clamping arm (123), so as to jointly clamp a mitral valve. The present application further provides a mitral valve clamping system (200), comprising said mitral valve clamping device (100).

Description

Mitral valve clipping device and mitral valve clipping system

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to and the benefit of the following patent applications, the entire contents of which are incorporated herein by reference:

A Chinese patent application entitled “Mitral Valve Clamping Device and Mitral Valve Clamping System”, with application number 202211215109.8, submitted to the State Intellectual Property Office of China on September 30, 2022.

Technical Field

The present application relates to the technical field of medical devices, and in particular, to a mitral valve clamping device and a mitral valve clamping system.

Background technique

This section merely provides background information related to the present disclosure and is not necessarily prior art.

The mitral valve is a part of the heart that sits between the left atrium and the left ventricle. Blood is pumped from the left atrium into the left ventricle, and when the left ventricle contracts to pump blood to the body, the mitral valve closes to prevent blood from being pumped back into the left atrium. In some patients, whether due to a genetic malformation, disease, or injury, the mitral valve does not close properly, resulting in a condition called regurgitation, in which blood is pumped into the atrium every time the heart muscle contracts. Regurgitation is a serious, often rapidly worsening condition that reduces circulation efficiency and must be corrected.

Mitral regurgitation is one of the most common valvular diseases today. The main causes include mitral ring dilatation, chordae insufficiency, mitral myxomatous degeneration, leaflet prolapse, rheumatic heart valve disease, ischemic lesions, etc. Mitral valvuloplasty and artificial valve replacement are the most effective methods for treating mitral regurgitation. However, since the operation requires extracorporeal circulation technology support, it causes great trauma to the human body. For elderly patients and patients with more complications, there is a relatively high complication and mortality rate.

Therefore, in recent years, medical personnel and researchers in various countries have explored transapical mitral valve repair technology, and the main interventional treatment method is mitral valve clamping. The mitral valve clamping delivers an implantable clip to the vicinity of the mitral valve through the apex of the heart, clamps and fixes the free edges of the anterior and posterior leaflets, so that the leaflets are well aligned at the end of contraction and regurgitation is reduced.

Summary of the invention

Based on this, the present application 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.

To achieve this goal, this application adopts the following technical solutions:

The present application provides a mitral valve clamping device, which is implanted through the apex of the heart. The mitral valve clamping device comprises:

An upper clamping assembly, the upper clamping assembly comprising a flexible clamping sheet and a first support member, wherein the first support member is connected to a distal end of the flexible clamping sheet;

A lower clamping assembly, the lower clamping assembly comprises 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 portion, the first connecting portion is connected to the second support member, and the second support member is connected to the proximal end of the flexible clamping sheet;

Among them, when the first support member drives the flexible clamping piece to move toward the proximal end and approach the second support member, the flexible clamping piece is in a folded state and can form 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 jointly clamp the mitral valve, and when the first support member drives the flexible clamping piece to move toward the distal end, the flexible clamping piece is in a straightened state.

The mitral valve clamping device of the present application is implanted through the apex of the left ventricle and can clamp the mitral valve. The flexible clamping piece of the upper clamping assembly of the mitral valve clamping device is in an extended state and can extend between the valves of the mitral valve. When the flexible clamping piece 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.

In some embodiments of the mitral valve clamping device of the present application, the mitral valve clamping device further comprises:

a first drive assembly, the first drive assembly is connected to the proximal end of the lower clamping assembly, the first drive member includes a connecting rod assembly, and the connecting rod assembly is respectively connected to the first clamping arm, the second clamping arm and the second support member,

Wherein, the connecting rod assembly can drive the second support member to move toward the distal end or the proximal end, so that the first clamping arm and the second clamping arm are opened or closed relative to the upper clamping assembly.

In some embodiments of the mitral valve clipping device of the present application,

The first drive assembly further includes a first base connected to the proximal end of the flexible clamping sheet;

The first clamping arm is further provided with a second connecting portion, and the second clamping arm is further provided with a third connecting portion;

The connecting rod assembly also includes:

a first control rod, wherein a distal end of the first control rod is connected to the second support member, and the first base is provided with a cavity for the first control rod to pass through;

a first connecting rod, one end of which is rotatably connected to the second connecting portion, and the first connecting rod supports the first clamping arm to rotate around the first connecting portion;

A second connecting rod, one end of which is rotatably connected to the third connecting portion, and the second connecting rod supports the second clamping arm to rotate around the first connecting portion.

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

In some embodiments of the mitral valve clamping device of the present application, adjacent mounting grooves and a partially inverted conical cavity are sequentially arranged in the axial direction in the cavity in the first base, the locking structure comprises a clamping member, the clamping member is sleeved on the first control rod, the clamping member is provided with an elastic portion capable of axial extension and contraction and the elastic portion is arranged in the mounting groove, and the clamping member is provided with a protruding end from the distal end to the proximal end;

Under the elastic force provided by the elastic part in the installation groove, the proximal outer side surface of the extended end abuts against the wall surface of the middle area of the inverted cone cavity, and the proximal inner side surface of the extended end can squeeze the first control rod.

In some embodiments of the mitral valve clamping device of the present application, a flange is provided at the distal end of the clamping member, the flange is sleeved on the outside of the first control rod, the upper end surface of the elastic portion is connected to the flange, and the lower end surface of the elastic portion is against the axial end surface of the mounting groove, or

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

In some embodiments of the mitral valve clamping device of the present application, the clamping member is provided with at least two protruding ends, and the protruding ends are arranged at equal intervals along the circumference of the first control rod.

In some embodiments of the mitral valve clamping device of the present application, the first drive assembly further includes a first traction member, a distal end of which is connected to a distal end of the clamping member, and under the action of the first traction member, the elastic portion can axially expand and contract.

In a second aspect of the present application, a mitral valve clamping system is further provided, the mitral valve clamping system is used to capture and clamp the mitral valve in the left ventricle, the mitral valve clamping system comprises the mitral valve clamping device as described in any one of the above items;

The mitral valve clamping system further comprises:

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.

In some embodiments of the mitral valve clamping system of the present application, the mitral valve clamping system further comprises a second control rod, wherein the second control rod is disposed in the catheter, and the distal end of the second control rod is threadedly connected to the proximal end of the first control rod.

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

In some embodiments of the mitral valve clamping system of the present application, the mitral valve clamping system further comprises a second traction member, which passes through the first through hole of the first support member and the guide ring in sequence, and passes through the catheter. Reach toward the operating handle.

In some embodiments of the mitral valve clamping system of the present application, a connecting rod is provided at the distal end of the catheter, and a connecting end surface between the connecting rod and the proximal end of the first base is S-shaped in the axial direction.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 shows the anatomical structure of the human heart;

FIG2 a shows a schematic diagram of a good mitral valve coaptation state of a human heart;

FIG2 b illustrates a state in which the mitral valve of a human heart cannot fully coapt;

FIG3 illustrates an embodiment of the mitral valve clamping device of the present application applied to a mitral valve clamping system;

FIG4 illustrates an embodiment of the mitral valve clamping device of the present application applied to a mitral valve clamping system;

FIG5 illustrates the folded state of the first clamping arm and the second clamping arm of the mitral valve clamping device of the present application;

FIG6a illustrates a top view of the mitral valve clamping device of the present application, wherein the first clamping arm and the second clamping arm are in a retracted state;

Fig. 6b is a cross-sectional view taken along line A-A of Fig. 6a;

FIG. 7 illustrates an embodiment of the locking structure of the mitral valve clamping device of the present application;

FIG8 illustrates a clamping member of the mitral valve clamping device of the present application;

FIG9 illustrates the connection relationship between the mitral valve clamping device and the mitral valve clamping system of the present application;

FIG10 illustrates a connecting rod assembly in the mitral valve clamping device of the present application, wherein the connecting rod assembly drives the lower clamping assembly to be in an open state;

FIG11 illustrates a connecting rod assembly of the mitral valve clamping device of the present application, wherein the connecting rod assembly drives the lower clamping assembly to be in a retracted state;

FIG12 illustrates the flexible clamping piece of the mitral valve clamping device of the present application in a folded state;

FIG13 illustrates an embodiment of a first driving assembly of the mitral valve clamping device of the present application;

FIG14 is a structural diagram showing the mitral valve clamping device of the present application installed in the mitral valve clamping system;

FIG15 illustrates an axonometric view of the mitral valve clamping system of the present application;

FIG16 illustrates a state diagram of the mitral valve clamping system of the present application in the left ventricle approaching the mitral valve;

FIG17 is a diagram showing a state in which the mitral valve clamping system of the present application captures the mitral valve in the left ventricle;

FIG. 18 illustrates a state diagram of the mitral valve clamping device in the mitral valve clamping system of the present application clamping the mitral valve.

The reference numerals are as follows:
100. Mitral valve clipping device;
110, upper clamping assembly; 111, flexible clamping sheet; 112, first clamping surface; 113, second clamping surface; 114, first support member; 115, first penetration hole; 116, barb structure;
120, lower clamping assembly; 121, first clamping arm; 122, second connecting portion; 123, second clamping arm; 124, third connecting portion; 125, second supporting member; 126, first connecting portion;
130, first driving assembly; 131, first base; 132, mounting groove; 133, inverted cone cavity;
140, connecting rod assembly; 141, first control rod; 142, first connecting rod; 143, second connecting rod;
150, locking structure; 151, clamping member; 152, elastic portion; 153, extension end; 154, flange; 155, proximal outer side surface of the extension end; 156, proximal inner side surface of the extension end;
160, first traction member;
200, mitral valve clamping system; 210, catheter; 220, operating handle; 230, second control rod; 240, guide member;
250, guide ring;
260, second traction member; 270, connecting rod; 271, "S"-shaped connecting end surface;
LA, left atrium; LV, left ventricle; MV, mitral valve; LF, valvular valve.

Detailed ways

In order to make the purpose, technical solutions and advantages of the present application clearer, exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although exemplary embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided in order to enable a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art.

It should be understood that the terms used in the text are only for the purpose of describing specific example embodiments, and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "one", "an" and "said" as used in the text may also be meant to include plural forms. The terms "include", "comprise", "contain", and "have" are inclusive, and therefore specify the existence of stated features, steps, operations, elements and/or parts, but do not exclude the existence or addition of one or more other features, steps, operations, elements, parts, and/or combinations thereof. The method steps, processes, and operations described in the text are not interpreted as necessarily requiring them to be performed in the specific order described or illustrated, unless the execution order is clearly indicated. It should also be understood that additional or alternative steps may be used.

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

For ease of description, spatial relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figure, such as "inside", "outside", "inner side", "outer side", "below", "below", "above", "above", etc. Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure. For example, if the device in the figure is turned over, then the elements described as "below other elements or features" or "below other elements or features" will 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 can be oriented otherwise (rotated 90 degrees or in other directions) and the spatial relative descriptors used in the text are interpreted accordingly.

In addition, it should be noted that in the field of interventional medical devices, the end of a medical device implanted in a human or animal body or a delivery system that delivers the medical device that is closer to the operator is generally called the "proximal end", and the end that is farther from the operator is called the "distal end", and the "proximal end" and "distal end" of any component of a medical device or delivery system are defined based on this principle. "Axial" generally refers to the length direction of the medical device when it is being delivered, and "radial" generally refers to the direction of the medical device that is perpendicular to its "axial direction", and the "axial" and "radial" of any component of a medical device are defined based on this principle.

Referring to Figures 1 to 5 and Figures 6a and 6b, the present application provides a mitral valve clamping device 100, which is implanted through the apex of the heart and can clamp the mitral valve in the left ventricle LV. The mitral valve clamping device 100 includes an upper clamping component 110 and a lower clamping component 120. The upper clamping component 110 and the lower clamping component 120 cooperate to capture the mitral valve LF and clamp the mitral valve.

Among them, the upper clamping assembly 110 includes a flexible clamping sheet 111 and a first support member 114. The distal end of the flexible clamping sheet 111 is connected to the first support member 114. The first support member 114 drives the flexible clamping sheet 111 to move toward the distal end, so that the flexible clamping sheet 111 is in an extended state. The first support member 114 drives the flexible clamping sheet 111 to move toward the proximal end, so that the flexible clamping sheet 111 is in a folded state.

The flexible clamping sheet 111 in the folded state is respectively above the first clamping arm 121 and the second clamping arm 123 , and is folded in half to form two layers of the flexible clamping sheet 111 , wherein the folding line is located on the outside of the flexible clamping sheet 111 .

When trying to capture the valve LF, the flexible clamping piece 111 is in a vertical state. At this time, the length of the flexible clamping piece 111 reaches the maximum and the contact area with the valve LF is also large. At this time, the first support member 114 drives the flexible clamping piece 111 to move and fold, so as to efficiently complete the capture of the valve LF.

The lower clamping assembly 120 includes a first clamping arm 121 and a second clamping arm 123. One end of the first clamping arm 121 and one end of the second clamping arm 123 are rotatably connected. When the first clamping arm 121 and the second clamping arm 123 are opened, the first clamping arm 121 and the first clamping arm 121 cooperate with the flexible clamping sheet 111 to capture the mitral valve LF in the left ventricle LV. When the first clamping arm 121 and the second clamping arm 123 are closed, the flexible clamping sheet 111 is respectively connected with the first clamping arm 121 and the second clamping arm 123. The mitral valve is closed while the mitral valve LF is clamped together.

The lower clamping assembly 120 also includes a second support member 125, which is connected to the proximal end of the flexible clamping sheet 111. When the first support member 114 drives the flexible clamping sheet 111 to move toward the proximal end and approach the second support member 125, the flexible clamping sheet 111 is in a folded state and forms a first clamping surface 112 and a second clamping surface 113, wherein the first clamping surface 112 and the first clamping arm 121 cooperate to clamp one valve LF of the mitral valve, and the second clamping surface 113 and the second clamping arm 123 cooperate to clamp the other valve LF of the mitral valve, so that the first clamping surface 112 and the second clamping surface 113 of the flexible clamping sheet 111 cooperate with the first clamping arm 121 and the second clamping arm 123 of the lower clamping assembly 120 to jointly clamp the mitral valve.

When performing surgery on the mitral valve, the mitral valve clamping device 100 provided in the present application is arranged in the mitral valve clamping system 200, and the mitral valve clamping system 200 is implanted in the left ventricle LV close to the mitral valve and through the apex; wherein the proximal end of the mitral valve clamping system 200 is provided with an operating handle 220, and the operator can use the operating handle 220 to first move the first support member 114 to the distal end, so that the flexible clamping sheet 111 moves toward the distal end with the first support member 114 and is in a straight state until it extends into between the two valves LF of the mitral valve, and at the same time, the first clamping arm 121 and the second clamping arm 123 of the lower clamping assembly 120 are in an open state, gradually approaching the mitral valve in the left ventricle LV; when the flexible clamping When the sheet 111 is able to capture the valve LF of the mitral valve, the operator operates the handle 220 to move the first support member 114 of the upper clamping assembly 110 proximally, and the flexible clamping sheet 111 is gradually folded as the first support member 114 moves proximally, and the first clamping arm 121 and the second clamping arm 123 of the lower clamping assembly 120 are gradually retracted, so that the first clamping arm 121 and the first clamping surface 112 of the flexible clamping sheet 111 cooperate to clamp one valve LF of the mitral valve, and the second clamping arm 123 and the second clamping surface 113 of the flexible clamping sheet 111 cooperate to clamp the other valve LF of the mitral valve. When the first clamping arm 121 and the second clamping arm 123 are fully retracted, the mitral valve is clamped and closed.

Among them, a first driving component 130 and a locking structure 150 are provided in the mitral valve clamping system 200, and the first driving component 130 is used to drive the upper clamping component 110 and the lower clamping component 120 of the mitral valve clamping device 100. Specifically, the first driving component 130 drives the first support member 114 to drive the flexible clamping plate 111 to move toward the distal end or the proximal end, and the first driving component 130 drives the first clamping arm 121 and the second clamping arm 123 of the lower clamping component 120 to open or retract; when the first clamping arm 121 and the second clamping arm 123 are fully retracted, the locking structure 150 can fix the retracted first clamping arm 121 and the second clamping arm 123 so that they are continuously in a locked state.

A guide member 240 is provided in the mitral valve clamping system 200 , and the guide member 240 cooperates with the flexible clamping piece 111 of the mitral valve clamping device 100 in a straightened state to accurately capture the valve LF of the mitral valve.

In one embodiment, the first drive assembly 130 and the locking structure 150 can be disposed in the mitral valve clamping device 100. After the mitral valve clamping system 200 completes clamping and fixing the mitral valve, the other components in the mitral valve clamping system 200 are separated from the mitral valve clamping device 100 and withdrawn from the left ventricle LV.

The following describes the mitral valve clamping device 100 of the present application and the working method of the mitral valve clamping system 200 used therein in conjunction with the accompanying drawings.

FIG1 illustrates the anatomical structure of the human heart, where LA is the left atrium, LV is the left ventricle, the mitral valve MV is located between the left atrium LA and the left ventricle LV, and the mitral valve MV has two membrane valves LF. Blood is pumped from the left atrium LA into the left ventricle LV. When the left ventricle LV contracts to pump blood into the body, the mitral valve MV closes to prevent blood from being pumped back into the left atrium LA. FIG2a illustrates the state of the mitral valve of the human heart being well coapted, and FIG2b illustrates the state of the mitral valve of the human heart not being fully coapted.

Figure 3 illustrates an embodiment of the mitral valve clamping device of the present application applied to the mitral valve clamping system, wherein the flexible clamping sheet 111 is in a folded state; in combination with Figure 3, the mitral valve clamping device 100 of the present application includes an upper clamping component 110 and a lower clamping component 120, in the upper clamping component 110, the distal end of the flexible clamping sheet 111 is connected to the first support member 114, and in the lower clamping component 120, the first clamping arm 121 and the second clamping arm 123 are rotatably connected; continuing to combine with Figure 12, wherein the flexible clamping sheet 111 is in a folded state, and can form a first clamping surface 112 and a second clamping surface 113, the first clamping surface 112 and the first clamping arm 121 are used to clamp one valve LF of the mitral valve, and the second clamping surface 113 and the second clamping arm 123 are used to clamp another valve LF of the mitral valve.

Figure 4 illustrates an embodiment of the mitral valve clamping device of the present application applied to the mitral valve clamping system, wherein the flexible clamping sheet 111 is in a straightened state; in combination with Figure 4, when the first support member 114 moves to the distal end, the flexible clamping sheet 111 is in a straightened state, and a guide member 240 is provided at the side end of the mitral valve clamping device 100, and the proximal end of the guide member 240 is connected to the catheter 210 of the mitral valve clamping system 200, and the extension length of the guide member 240 to the distal end is adapted to the length of the valve LF of the mitral valve, and the guide member 240 and the flexible clamping sheet 111 can accurately extend together between the two valves LF of the mitral valve.

Since the operation is performed while the heart is beating, the mitral valve clamping device 100 needs to accurately capture and clamp the valve LF during the opening or closing of the mitral valve. The guide member 240 provided in the mitral valve clamping device 100 provided in the present application can help the operator effectively complete the accurate positioning from the apex to the valve LF, thereby efficiently completing the leaflet capture.

4 , a barb structure 116 is further provided on the flexible clamping sheet 111 for capturing and fixing the mitral valve LF. The barb structure 116 is formed on the first clamping surface 112 and the second clamping surface 113 of the flexible clamping sheet 111 in a folded state.

Continuing with Figures 3 and 4, the first clamping arm 121 and the second clamping arm 123 of the lower clamping assembly 120 are in an open state. Combined with Figures 16 and 17, it can be seen that the mitral valve clamping device 100 of the present application is arranged in the mitral valve clamping system 200. When the first clamping arm 121 and the second clamping arm 123 of the mitral valve clamping device 100 are in an open state and the flexible clamping sheet 111 is in an extended state, the guide member 240 and the flexible clamping sheet 111 can be accurately extended together between the valves LF of the mitral valve.

Specifically, the process in which the first support member 114 drives the flexible clamping piece 111 to move toward the distal end so that the flexible clamping piece 111 is in a straightened state is as follows:

The first support member 114 of the mitral valve clamping device 100 of the present application is provided with a first through hole 115, and the catheter 210 of the mitral valve clamping system 200 is provided with a guide member 240, which is provided at the side end of the mitral valve clamping device 100, preferably The guide member 240 may include a first guide member and a second guide member, which are symmetrically arranged on both sides of the mitral valve clamping device 100. The extension length of the guide member 240 or the first guide member or the second guide member to the distal end is adapted to the valve LF length of the mitral valve. A guide ring 250 may also be provided at the distal end of the guide member 240, and the guide ring 250 is used to adjust the direction of the traction member at the distal end of the guide member 240. More specifically, a first guide ring is provided at the distal end of the first guide member, and a second guide ring is provided at the distal end of the second guide member. The mitral valve clamping device 100 is also provided with a second traction member 260, which passes through the first penetration hole 115, the first guide ring 250, and the second guide ring 250 in sequence, and then both ends of the second traction member 260 extend to the operating handle 220 through the catheter 210.

The operator continuously pulls the two ends of the second traction member 260 in the operating handle 220 of the mitral valve clamping system 200, and the second traction member 260 pulls the first support member 114 to move distally through the first through hole 115, so that the flexible clamping sheet 111 moves distally with the first support member 114 and gradually straightens.

Figure 5 illustrates the folded state of the first clamping arm and the second clamping arm of the mitral valve clamping device of the present application. In conjunction with Figure 5, the flexible clamping sheet 111 is in a folded state, folded between the first clamping arm 121 and the second clamping arm 123. In conjunction with Figure 18, it can also be seen that when the first clamping arm 121 and the second clamping arm 123 are in a completely folded state, the first clamping surface 112 of the flexible clamping sheet 111 and the first clamping arm 121 cooperate to clamp one valve LF of the mitral valve, and the second clamping surface 113 of the flexible clamping sheet 111 cooperates with the second clamping arm 123 to clamp the other valve LF of the mitral valve, so that the mitral valve clamping device 100 clamps the mitral valve.

Figure 6a shows a top view of the mitral valve clamping device of the present application, wherein the first clamping arm 121 and the second clamping arm 123 are in a retracted state, and Figure 6b is an A-A cross-sectional view of Figure 6a; in combination with Figure 6a and Figure 6b, the mitral valve clamping device 100 of the present application includes an upper clamping assembly 110 and a lower clamping assembly 120, wherein, in the upper clamping assembly 110, the distal end of the flexible clamping sheet 111 is connected to the first support member 114, and the proximal end of the flexible clamping sheet 111 is connected to the second support member 125, and the second support member 125 is also connected to the first connecting portion 126, and the first connecting portion 126 is composed of one end of the first clamping arm 121 and one end of the second clamping arm 123 rotatably connected, and the first connecting portion 126 may include a rotating shaft, which is rotatably connected to one end of the first clamping arm 121 and one end of the second clamping arm 123 respectively.

The mitral valve clamping device 100 further includes a first drive assembly 130, which includes a first base 131. The distal end of the flexible clamping sheet 111 can also be connected to the first base 131, so as to better fix the flexible clamping sheet 111 at the proximal end.

FIG9 illustrates the connection relationship between the mitral valve clamping device of the present application and the mitral valve clamping system, and FIG10 illustrates the connecting rod assembly in the mitral valve clamping device of the present application, wherein the connecting rod assembly 140 drives the lower clamping assembly 120 to be in an open state. In combination with FIG9 and FIG10, the first driving assembly 130 of the mitral valve clamping device 100 of the present application includes a first base 131 and a connecting rod assembly 140, wherein the connecting rod assembly 140 also includes a first control rod 141, a first connecting rod 142 and a second connecting rod 143, the distal end of the first control rod 141 is connected to the second support member 125, and the proximal end of the first control rod 141 is connected to the mitral valve clamping system 200. The catheter 210 is connected, and by controlling the operating handle 220 of the mitral valve clamping system 200, the first control rod 141 can drive the second support member 125 to move toward the distal end or the proximal end.

The first connecting rod 142 is used to support the first clamping arm 121 to rotate around the first connecting portion 126. Specifically, the first clamping arm 121 is provided with a second connecting portion 122. One end of the first connecting rod 142 is rotatably connected to the second connecting portion 122, and the other end of the first connecting rod 142 is rotatably connected to the first base 131.

The second connecting rod 143 is used to support the second clamping arm 123 to rotate around the first connecting portion 126. Specifically, the second clamping arm 123 is provided with a third connecting portion 124. One end of the second connecting rod 143 is rotatably connected to the third connecting portion 124, and the other end of the second connecting rod 143 is rotatably connected to the first base 131.

It should be noted that the rotatable connection between one end of the first connecting rod 142 and the second connecting part 122, and the rotatable connection between the other end of the first connecting rod 142 and the first base 131 can be arranged according to specific circumstances. For example, they can be hinged, and a rotating shaft can be set in the second connecting part 122 or the first base 131, and a bearing or a bushing can be set on the first connecting rod 142, and the bearing or the bushing can rotate in cooperation with the rotating shaft. Similarly, a rotating shaft can be set on the first connecting rod 142, and a bearing or a bushing can be set in the second connecting part 122 or the first base 131.

It should be noted that the rotatable connection between one end of the second connecting rod 143 and the third connecting part 124, and the rotatable connection between the other end of the second connecting rod 143 and the first base 131 can be arranged according to specific circumstances. For example, they can be hinged; a rotating shaft can be set in the third connecting part 124 or the first base 131, and a bearing or a bushing can be set on the second connecting rod 143, and the bearing or the bushing can be rotated in cooperation with the rotating shaft. Similarly, a rotating shaft can be set on the second connecting rod 143, and a bearing or a bushing can be set in the third connecting part 124 or the first base 131.

It can be seen from the above embodiments that in the mitral valve clamping device 100 provided in the present application, the connecting rod assembly 140 in the first drive assembly 130 is respectively connected to the first clamping arm 121, the second clamping arm 123 and the second support member 125, and the first control rod 141 can drive the second support member 125 to move distally so that the first clamping arm 121 and the second clamping arm 123 are opened relative to the upper clamping assembly 110. The first control rod 141 can also drive the second support member 125 to move proximally so that the first clamping arm 121 and the second clamping arm 123 are retracted relative to the upper clamping assembly 110, wherein Figure 13 illustrates an implementation scheme of the first drive assembly of the mitral valve clamping device of the present application.

The present application provides the above-mentioned preferred implementation mode. In applications, the connecting rod assembly 140 can be specifically arranged according to the technical inspiration provided by the present application to achieve the opening or closing of the first clamping arm 121 and the second clamping arm 123 relative to the upper clamping assembly 110.

It should be understood that the first drive component 130 or the connecting rod assembly 140 in the first drive component 130 can be used as a part of the mitral valve clamping device 100, and can also be arranged in the mitral valve clamping system 200. After the first drive component 130 or the connecting rod assembly 140 is connected to the mitral valve clamping device 100, the mitral valve is captured and clamped.

FIG. 11 illustrates a connecting rod assembly of the mitral valve clamping device of the present application, wherein the connecting rod assembly 140 drives the lower clamping assembly 120 is in a retracted state. Combined with Figure 11, the mitral valve clamping device 100 is arranged in the mitral valve clamping system 200. The proximal operating handle 220 of the mitral valve clamping system 200 can make the various components in the connecting rod assembly 140 rotate relative to each other, and support the first clamping arm 121 and the second clamping arm 123 to rotate around the first connecting portion 126. Finally, the first clamping arm 121 and the second clamping arm 123 are in a completely retracted state.

In one embodiment of the present application, in the mitral valve clamping device 100, a locking structure 150 is provided in the first base 131, and the locking structure 150 is used to clamp the first control rod 141 in the connecting rod assembly 140 to prevent the relative movement between the first control rod 141 and the first base 131 or the lower clamping assembly 120; wherein the locking structure 150 can clamp the first control rod 141 under normal conditions, and when the first control rod 141 needs to be moved, the locking structure 150 releases the first control rod 141, so that the first control rod 141 can move freely to the proximal end or the distal end.

In another embodiment of the present application, the locking structure 150 can also clamp the first control rod 141 after the upper clamping assembly 110 and the lower clamping assembly 120 capture and clamp the mitral valve to prevent the first control rod from moving relative to the first base 131 or the lower clamping assembly 120, thereby preventing the lower clamping assembly 120 and the upper clamping assembly 110 from loosening.

In one embodiment of the present application, in conjunction with FIG. 6 b , in the mitral valve clamping device 100, the first driving assembly 130 includes a first base 131 and a first control rod 141, the first base 131 is provided with a cavity for the first control rod 141 to pass through, the distal end of the first control rod is connected to the second support member 125, and a locking structure 150 is further provided in the first base 131, the locking structure 150 is used to clamp the first control rod 141, and the locking structure 150 can prevent the first control rod 141 from axially moving relative to the first base 131 or the lower clamping assembly 120. In this embodiment, when the first control rod 141 drives the second support member 125, After the first clamping arm 121 and the second clamping arm 123 are fully retracted, the locking structure 150 fixes the first control rod relative to the first base 131 or the lower clamping assembly 120 to prevent the first control rod from driving the lower clamping assembly 120 to move, thereby preventing the first clamping arm 121 and the second clamping arm 123 from further relative rotation, making the clamping device clamp the mitral valve more secure. In this embodiment, a locking structure 150 is further provided in the mitral valve clamping device 100. When the clamping device captures and clamps the mitral valve, it ensures that the mitral valve clamping device 100 can be more reliably maintained in a clamped state to prevent loosening.

In another embodiment of the present application, in combination with Figures 6b and 7, in the mitral valve clamping device 100, a mounting groove 132 and a partially inverted cone cavity 133 are arranged in the cavity of the first base 131, and the mounting groove 132 and the inverted cone cavity 133 are arranged adjacent to each other. Along the axial direction of the first base 131, the mounting groove 132 is arranged on the distal side, and the inverted cone cavity 133 is arranged on the proximal side.

The locking structure 150 also includes a clamping member 151, which has an axially retractable elastic portion 152 and an extended end 153 extending from the distal end to the proximal end. The clamping member 151 is sleeved on the first control rod 141, wherein the elastic portion 152 is arranged in the mounting groove 132 of the first base 131 and can provide axial elastic force, and the extended end 153 is at least partially located in the inverted cone cavity 133. Under the action of the elastic force of the elastic portion 152, the proximal outer side surface 155 of the extended end abuts against the wall surface of the middle area of the inverted cone cavity 133, and the proximal inner side surface 156 of the extended end can squeeze the first control rod 141.

When the first control rod 141 is pushed toward the distal end, the inner side surface 156 of the proximal end of the extended end clamps the first control rod 141, and the extended end The proximal outer side surface 155 of the end abuts against the wall surface of the inverted cone cavity 133, and the inner diameter of the inverted cone cavity 133 gradually narrows from the proximal end to the distal end. Therefore, under the extrusion of the wall surface of the inverted cone cavity 133 of the first base 131 and the first control rod 141, the clamping member 151 is prevented from moving toward the distal end. At the same time, the proximal inner side surface 156 of the protruding end clamps the first control rod 141 and also prevents the first control rod 141 from moving toward the distal end. However, when the first control rod 141 is moved toward the proximal end, since the inner diameter of the inverted cone cavity 133 gradually increases from the distal end to the proximal end, there is effective space in the inverted cone cavity 133 for the proximal end of the protruding end 153 to move outward. Therefore, the proximal inner side surface 156 of the protruding end no longer squeezes the first control rod 141, so that the first control rod 141 can move toward the proximal end.

In the above embodiment, the locking structure 150 can clamp the first control rod 141 and thereby prevent the first control rod 141 from moving relative to the first base 131. In the mitral valve clamping device 100, after the upper clamping assembly 110 and the lower clamping assembly 120 capture and clamp the mitral valve, due to the action of the locking structure 150, the first control rod 141 no longer has the possibility of further moving in the proximal direction or the distal direction, thereby ensuring that the clamping device can stably clamp the mitral valve.

In one embodiment of the mitral valve clamping device of the present application, a flange 154 is provided at the distal end of the clamping member 151 and is sleeved on the first control rod 141. The upper end surface of the elastic portion 152 of the clamping member 151 is connected to the flange 154, and the lower end surface of the elastic portion 152 is connected to the axial end surface of the mounting groove 132. Under the extrusion of the flange 154 and the axial end surface of the mounting groove 132, the elastic portion 152 is in an axial compression state to provide elastic force, so that the proximal outer surface 155 of the protruding end of the clamping member 151 abuts against the wall surface of the middle area of the inverted cone cavity 133, and the proximal inner surface 156 of the protruding end can squeeze the first control rod 141.

In one embodiment of the mitral valve clamping device of the present application, different from the above-mentioned embodiments, the lower end surface of the elastic portion 152 is connected to the flange 154, and the upper end surface of the elastic portion 152 is connected to the axial upper end surface of the mounting groove 132. The elastic portion 152 is in an axially stretched state to provide elastic force, and can also make the proximal outer side surface 155 of the protruding end of the clamping member 151 abut against the wall surface of the middle area of the inverted cone cavity 133, and the proximal inner side surface 156 of the protruding end can squeeze the first control rod 141.

It should be noted that in the above two embodiments, in the installation groove 132, the elastic portion 152 of the clamping member 151 can provide elastic force regardless of being in a compressed state or in a stretched state. Relative to the first control rod 141, this elastic force is an axial traction force from the proximal end to the distal end, so that the protruding end 153 of the clamping member 151 can squeeze the inner wall surface of the inverted conical cavity 133 on the outer side of the protruding end 153 within the limited space of the inverted conical cavity 133, and can squeeze the first control rod 141 on the inner side of the protruding end 153, thereby achieving the locking of the mitral valve clamping device 100.

In one embodiment of the mitral valve clamping device of the present application, when the clamping member 151 and the flange 154 are two independent components, the flange 154 can be fixedly connected to the first control rod 141. In this connection mode, the first control rod 141 can drive the flange 154 to move axially from the distal end to the proximal end while overcoming the elastic force of the elastic part 152.

In another embodiment of the mitral valve clamping device of the present application, the flange 154 is a part of the clamping member 151, which is sleeved on the first control rod 141. When the first control rod 141 moves axially, it is necessary to release the clamping force of the protruding end 153 of the clamping member 151 on the first control rod. Therefore, in this embodiment, the mitral valve clamping device 100 is further provided with a first traction member. 160, the distal end of the first traction member 160 is connected to the flange 154 of the clamping member 151, or the distal end of the first traction member 160 is connected to the distal end of the protruding end 153 of the clamping member 151, and the proximal end of the first traction member 160 extends toward the operating handle 220. By pulling the first traction member 160, the elastic force provided by the elastic portion 152 of the clamping member 151 can be overcome to release the squeezing or clamping of the protruding end 153 of the clamping member 151 on the first control rod 141, so that the first control rod 141 can move toward the distal end.

In one embodiment of the mitral valve clamping device of the present application, two protruding ends 153 of the clamping member 151 are provided, and the two protruding ends 153 can be symmetrically arranged on both sides of the first control rod 141, so as to better clamp the first control rod 141.

In one embodiment of the mitral valve clamping device of the present application, as shown in Figures 7 and 8, three protruding ends 153 of the clamping member 151 are arranged, and the three protruding ends 153 are arranged at equal intervals along the circumference of the first control rod 141. In this embodiment, the protruding ends 153 can clamp the first control rod 141 in three directions, thereby better preventing the first control rod 141 from moving.

In the above two embodiments, the clamping member 151 provides clamping forces in two or three directions to the first control rod 141. Compared with the locking force of a single contact point and a single direction, the locking structure 150 in the mitral valve clamping device 100 of the present application will not have the risk of falling off due to loose closing or opening.

In the mitral valve clamping device provided in the present application, the flexible clamping sheet 111 can be made of nickel-titanium alloy material, and when the elastic part 152 in the clamping member 151 is set as a spring, the spring can be made of stainless steel material or nickel-titanium alloy material. The biocompatible nickel-titanium alloy material or stainless steel material can better integrate with human tissue.

The present application also provides a mitral valve clamping system. Referring to Figures 15 to 18, the mitral valve clamping device 100 can be delivered to the vicinity of the mitral valve of the left ventricle LV with the help of the mitral valve clamping system 200. By operating the operating handle 220 of the mitral valve clamping system 200, the mitral valve clamping device 100 can capture and clamp the mitral valve, and by providing a locking structure 150, the mitral valve clamping device 100 can be prevented from loosening.

In one embodiment of the mitral valve clamping system provided in the present application, the mitral valve clamping system 200 includes a mitral valve clamping device 100 as described in any of the above items, and also includes a catheter 210 and an operating handle 220, wherein the distal end of the catheter 210 is connected to the proximal end of the mitral valve clamping device 100, more specifically, the distal end of the catheter 210 can be connected to the proximal end of the first base 131 of the mitral valve clamping device 100; the proximal end of the catheter 210 is connected to the operating handle 220, and by controlling the operating handle 220, the mitral valve clamping device 100 is capable of capturing and clamping the mitral valve, wherein Figure 14 shows a structural diagram of the mitral valve clamping device of the present application installed in the mitral valve clamping system.

In one embodiment of the mitral valve clamping system provided in the present application, a guide structure is also provided. Specifically, a guide member 240 is provided at the distal end of the catheter 210, and the guide member 240 is provided at the side end of the mitral valve clamping device 100. A wire ring 250 is provided at the distal end of the guide member 240, and the extension length of the guide member 240 to the distal end is adapted to the valve LF length of the mitral valve; with the aid of the guide structure, the first support member 114 of the mitral valve clamping device can be moved to the distal end, while the flexible clamping sheet 111 is in a straightened state.

In a more preferred embodiment, two guide members 240 are disposed opposite to each other at the distal end of the catheter 210. The guide members 240 are arranged on both sides of the mitral valve clipping device 100 , and guide rings 250 are provided at the distal ends of the two oppositely arranged guide members 240 .

In one embodiment of the mitral valve clamping system provided in the present application, it also includes a second traction member 260. The second traction member 260 passes through the guide ring 250 of one guide member 240, the first penetration hole 115 of the first support member 114, and the guide ring 250 of another guide member 240 in sequence, and then extends to the operating handle 220 through the catheter 210; in this embodiment, the first penetration hole 115 is also provided on the first support member 114 of the mitral valve clamping device 100, for the second traction member 260 to pass through to pull the first support member 114 to move distally.

In one embodiment of the mitral valve clamping system provided in the present application, a connecting rod 270 is provided at the distal end of the catheter 210, and the connecting rod 270 is connected to the proximal end of the first base 131, wherein the connecting end face can be configured to be curved. Preferably, the connecting end face is S-shaped in the axial direction, namely, an "S"-shaped connecting end face 271. The connecting rod 270 is connected to the proximal end of the first base 131 with a curved cross-section, which can prevent the connection from loosening.

In one embodiment of the mitral valve clamping system provided in the present application, a second control rod 230 is arranged in the catheter 210, and the second control rod 230 is threadedly connected to the first control rod 141; when the mitral valve clamping device 100 completes the capture and clamping of the mitral valve, the first control rod 141 and the second control rod 230 can be separated more conveniently.

The above-described embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be construed as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent application shall be subject to the attached claims.

Claims (13)

A mitral valve clamping device, characterized in that the mitral valve clamping device comprises: An upper clamping assembly, the upper clamping assembly comprising a flexible clamping sheet and a first support member, wherein the first support member is connected to a distal end of the flexible clamping sheet; A lower clamping assembly, the lower clamping assembly comprises 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 portion, the first connecting portion is connected to the second support member, and the second support member is connected to the proximal end of the flexible clamping sheet; Among them, when the first support member drives the flexible clamping piece to move toward the proximal end and approach the second support member, the flexible clamping piece is in a folded state and can form 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 jointly clamp the mitral valve, and when the first support member drives the flexible clamping piece to move toward the distal end, the flexible clamping piece is in a straightened state. The mitral valve clamping device according to claim 1, characterized in that the mitral valve clamping device further comprises: a first drive assembly, the first drive assembly is connected to the proximal end of the lower clamping assembly, the first drive member includes a connecting rod assembly, and the connecting rod assembly is respectively connected to the first clamping arm, the second clamping arm and the second support member, Wherein, the connecting rod assembly can drive the second support member to move toward the distal end or the proximal end, so that the first clamping arm and the second clamping arm are opened or closed relative to the upper clamping assembly. The mitral valve clamping device according to claim 2, characterized in that: The first drive assembly further includes a first base connected to the proximal end of the flexible clamping sheet; The first clamping arm is further provided with a second connecting portion, and the second clamping arm is further provided with a third connecting portion; The connecting rod assembly also includes: a first control rod, wherein a distal end of the first control rod is connected to the second support member, and the first base is provided with a cavity for the first control rod to pass through; a first connecting rod, one end of which is rotatably connected to the second connecting portion, and the first connecting rod supports the first clamping arm to rotate around the first connecting portion; A second connecting rod, one end of which is rotatably connected to the third connecting portion, and the second connecting rod supports the second clamping arm to rotate around the first connecting portion. The mitral valve clamping device according to claim 3 is characterized in that a locking structure is provided in the first base, and the locking structure is used to clamp the first control rod to prevent the relative movement between the first control rod and the first base. The mitral valve clamping device according to claim 4, characterized in that the inner edge of the cavity in the first base The mounting grooves and the partially inverted conical cavity are arranged in sequence in the axial direction, the locking structure comprises a clamping member, the clamping member is sleeved on the first control rod, the clamping member is provided with an elastic part capable of axial extension and contraction and the elastic part is arranged in the mounting groove, and the clamping member is provided with an extended end from the distal end to the proximal end; Under the elastic force provided by the elastic part in the installation groove, the proximal outer side surface of the extended end abuts against the wall surface of the middle area of the inverted cone cavity, and the proximal inner side surface of the extended end can squeeze the first control rod. The mitral valve clamping device according to claim 5 is characterized in that a flange is provided at the distal end of the clamping member, the flange is sleeved on the outside of the first control rod, the upper end surface of the elastic portion is connected to the flange, and the lower end surface of the elastic portion abuts against the axial end surface of the mounting groove, or The lower end surface of the elastic part is connected to the flange, and the upper end surface of the elastic part abuts against the axial end surface of the mounting groove. The mitral valve clamping device according to claim 6 is characterized in that the clamping member is provided with at least two protruding ends, and the protruding ends are arranged at equal intervals along the circumference of the first control rod. The mitral valve clamping device according to any one of claims 5-7 is characterized in that the first drive assembly also includes a first traction member, the distal end of the first traction member is connected to the distal end of the clamping member, and under the action of the first traction member, the elastic part can axially expand and contract. 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 comprises the mitral valve clamping device according to any one of claims 1 to 8; The mitral valve clamping system further comprises: 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. The mitral valve clamping system according to claim 9 is characterized in that the mitral valve clamping system also includes a second control rod, the second control rod is arranged in the catheter, and the distal end of the second control rod is threadedly connected to the proximal end of the first control rod. The mitral valve clamping system according to claim 9 is characterized in that a guide member is provided at the side end of the catheter of the mitral valve clamping device, the extension length of the guide member to the distal end is adapted to the valve length of the mitral valve, and a guide ring is provided at the distal end of the guide member. The mitral valve clamping system according to claim 9, characterized in that the mitral valve clamping system further comprises a second traction member, the second traction member sequentially passes through the first through hole of the first support member and the guide ring, and passes through the The catheter extends toward the operating handle. The mitral valve clamping system according to claim 9 is characterized in that a connecting rod is provided at the distal end of the catheter, and the connecting end surface between the connecting rod and the proximal end of the first base is S-shaped in the axial direction.