Clamping unit and heart valve clamping device

Abstract

The utility model provides a clamping unit and a heart valve clamping device. The clamping unit comprises a fixed shaft; one end of the clamping part is pivoted on the fixed shaft; the other end of the clamping part is pivoted on the fixed shaft; the adjusting seat can move close to the fixed shaft or away from the fixed shaft, so that the opening and closing angle of the clamping part is adjusted; the clamping part comprises a first clamping piece and a second clamping piece, and the first clamping piece and the second clamping piece are connected through a flexible piece; the flexible part can be bent so that the second clamping part can abut against the first clamping part. The first clamping piece and the second clamping piece are connected into a whole, so that when the clamping parts rotate, the first clamping piece and the second clamping piece move synchronously, the distance between the first clamping piece and the second clamping piece does not change obviously along with the cardiac pulsation process, valve leaflets are prevented from sliding between the two clamping parts, and therefore stable clamping force is ensured, and the valve leaflets are prevented from sliding. The separation between the valve leaflet and the clamping part is avoided.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to a clamping unit and a heart valve clamping device. Background Art

[0002] The mitral valve and tricuspid valve are one-way valves from the atria to the ventricles in the heart. When the leaflets of the mitral valve and tricuspid valve cannot align with each other during cardiac systole, blood will enter the atria from the gap between the leaflets, forming backflow. In the related art, clamping devices are often used to clamp the leaflets to prevent the formation of such backflow. However, such devices have many problems such as leaflet tearing and clip falling off after implantation. In fact, during cardiac beating, the myocardium continuously contracts and relaxes and pulls the leaflets, and there is a regularly changing pulling force between the leaflets and the clamping structure of the clip. Due to the pulling of the leaflets, the clamping arms in the clamping structure move away from the clamping members in the clamping structure, thereby increasing the distance between the clamping arms and the clamping members and reducing the clamping force of the clip. When the clip design makes the clamping force unable to resist the pulling force of the leaflets, the leaflets will detach from the clip, causing the clip to fall off and fail to function. At the same time, during the repeated pulling of the leaflet, the clamping arm repeatedly fits in and moves away from the clamping piece, and the barbs on the clamping piece insert into the leaflet. During the repeated pulling of the leaflet, the clamping piece will repeatedly insert into and move away from the leaflet, causing the leaflet to tear or even cause the leaflet to detach from the clamp. Utility Model Content

[0003] In order to overcome at least one of the problems in the related art, the first aspect of the present invention provides a heart valve clamping device.

[0004] Wherein, the heart valve clamping device comprises:

[0005] Fixed axis;

[0006] a clamping portion, one end of which is pivotally connected to the fixed shaft;

[0007] An adjustment seat, which can move closer to or away from the fixed axis to adjust the opening and closing angle of the clamping portion;

[0008] The clamping portion includes a first clamping member and a second clamping member, and the first clamping member and the second clamping member are connected by a flexible member; wherein the flexible member can be bent so that the second clamping member and the first clamping member abut against each other.

[0009] An optional embodiment further includes a support portion, one end of which is pivotally connected to the adjustment seat, and the other end of which is pivotally connected to the middle portion of the first clamping member.

[0010] In an optional embodiment, the support portion is made of an elastic material and can be in a compressed state or an extended state as the clamping portion pivots.

[0011] In an optional embodiment, the first clamping member, the second clamping member and the flexible member are an integrated component; or,

[0012] The first clamping member, the second clamping member and the flexible member are all independent components, and the first clamping member and the second clamping member are connected through the flexible member.

[0013] In an optional embodiment, the flexible member includes a hollow structure; and / or at least a portion of the clamping portion is made of a memory alloy.

[0014] In an optional embodiment, barbs are provided on the surface of the second clamping member facing the first clamping member.

[0015] In an optional embodiment, in an initial state, the first clamping member and the second clamping member are arranged in parallel or at a negative angle.

[0016] In an optional embodiment, a driving shaft is further included, wherein the driving shaft is disposed inside the fixed shaft, and an outer surface of the driving shaft is threadedly engaged with an inner surface of the fixed shaft;

[0017] The end of the driving shaft away from the fixed shaft is connected to the adjustment seat in a limiting manner, and the limiting connection limits the axial movement of the driving shaft relative to the adjustment seat.

[0018] In an optional embodiment, a retaining ring is provided at one end of the adjustment seat and a limiting pin is provided at the other end, and the end of the drive shaft away from the fixed shaft is limited between the retaining ring and the limiting pin.

[0019] An optional embodiment further includes a driving member, which is connected to the end of the driving shaft away from the adjustment seat, and is used to control the movement state of the driving shaft.

[0020] In an optional embodiment, the driving member includes a driving rod and a dissociation rod, wherein

[0021] The driving rod is engaged with the driving shaft;

[0022] The driving rod includes a through hole extending along the axis of the driving rod. The dissociation rod is arranged in the through hole and is detachably connected to the driving shaft to control the engagement or separation state between the driving rod and the driving shaft.

[0023] In an optional embodiment, at least one of the drive shaft and the drive rod is provided with a slot, and the other is provided with a buckle, and the slot and the buckle cooperate to enable the drive rod to be engaged and connected with the drive shaft.

[0024] A second aspect of the present invention provides a detachable clamping unit for a heart valve clamping device, comprising:

[0025] The second clamping member and the flexible member are integrated components. The flexible member can be bent so that the two ends of the flexible member are parallel to each other or close to each other.

[0026] In an optional embodiment, the flexible member includes a wave-shaped connecting member, and / or a reinforcing member is provided between the wave-shaped connecting members.

[0027] A third aspect of the present invention provides a heart valve clamping device, comprising:

[0028] Fixed axis;

[0029] a clamping portion, one end of which is pivotally connected to the fixed shaft;

[0030] An adjustment seat, which can move closer to or away from the fixed axis to adjust the opening and closing angle of the clamping portion;

[0031] The clamping portion includes a first clamping member and the detachable clamping unit described in any one of the second aspects, and the end of the flexible member away from the second clamping member is detachably connected to the first clamping member;

[0032] The flexible member can be bent so that the second clamping member and the first clamping member abut against each other.

[0033] In an optional embodiment, a first connecting portion is provided at the end of the flexible member away from the second clamping member, a second connecting portion is provided on the first clamping member, and the first connecting portion is detachably connected to the second connecting portion.

[0034] In an optional embodiment, one of the first connecting portion and the second connecting portion is a buckle, and the other is a slot.

[0035] In an optional embodiment, the flexible member includes a hollow structure; and / or at least a portion of the clamping portion is made of a memory alloy.

[0036] In an optional embodiment, in an initial state, the first clamping member and the second clamping member are arranged in parallel or at a negative angle.

[0037] The technical solution of the utility model has the following advantages or beneficial effects:

[0038] (1) The present invention facilitates the operator to control the instrument and improves the operating efficiency by reasonably adjusting the opening and closing angles of the clamping part. When the instrument is retrieved due to poor surgical results, a large opening and closing angle can reduce the risk of the clamping part hooking the tendon cord, thereby improving the safety and fault tolerance of the operation. When the clamping effect meets the requirements, the clamping part can be folded to reduce the space occupied by the instrument in the human body, thereby improving safety. The first clamping member and the second clamping member of the present invention are connected as a whole, so that when the clamping part rotates, the first clamping member and the second clamping member move synchronously, the motion trajectories of the two in space are highly overlapped, and the distance between the two does not change significantly with the heart beating process. In this case, when the leaflet pulls the clamping part to move or rotate, the synchronous movement of the first clamping member and the second clamping member will prevent the leaflet from sliding between the two clamping parts, thereby ensuring a stable clamping force and preventing the leaflet from detaching from the clamping part.

[0039] (2) The support portion of the present invention is elastic, so that it can adapt to the pulling force of the leaflet on the clamping portion during the heart beat, so that the clamping portion can provide a stable clamping force for the leaflet. The relative position of the leaflet clamped in the middle of the clamping portion and the clamping portion, especially the barb on the second clamping member, is stable, and the relative position of the two does not change with the beating of the heart, and the risk of the barb tearing the leaflet is significantly reduced.

[0040] (3) The clamping portion of the present invention can provide a stable clamping force. Therefore, compared with the prior art, the present invention only requires fewer barbs to anchor the leaflets to ensure the stability of the leaflet clamping. In addition, fewer barbs can reduce the risk of barbs damaging the leaflets during the release and re-implantation of the clamping device, thereby improving the safety and success rate of the operation and reducing the risk of barbs tearing the leaflets during cardiac pulsation.

[0041] (4) The drive member and the drive shaft of the present invention jointly control the opening and closing state of the clamping portion. After the clamping portion stably clamps the valve leaflet, the drive member can be removed, causing the drive shaft to self-lock on the fixed shaft to ensure the clamping function of the device. This reduces the weight of the device remaining in the human body, reduces the risk of valve leaflet tearing due to excessive clamping of the device, and improves the safety and reliability of the device. Furthermore, in the clamping state, the clamping portion is in a retracted state, making the overall structural size of the device smaller. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] The accompanying drawings are provided to facilitate a better understanding of the present invention and do not constitute an undue limitation of the present invention.

[0043] Figure 1 is a perspective schematic diagram of a heart valve clamping device according to one embodiment of the present utility model;

[0044] Figure 2is a front view schematic diagram of a heart valve clamping device according to one embodiment of the present invention;

[0045] Figure 3 is a cross-sectional schematic diagram of a heart valve clamping device in a clamped state according to one embodiment of the present invention;

[0046] Figure 4 is a schematic cross-sectional view of a heart valve clamping device in a clamped state according to another embodiment of the present invention;

[0047] Figure 5 is a perspective schematic diagram of a heart valve clamping device according to another embodiment of the present invention;

[0048] Figure 6 is a schematic cross-sectional view of a heart valve clamping device in a clamped state according to another embodiment of the present invention;

[0049] Figure 7 is an enlarged schematic diagram of a flexible member of a heart valve clamping device according to one embodiment of the present utility model;

[0050] Figure 8 is an enlarged schematic diagram of a flexible member of a heart valve clamping device according to another embodiment of the present invention;

[0051] Figure 9 is an enlarged cross-sectional schematic diagram of a clamping portion of a heart valve clamping device according to one embodiment of the present utility model;

[0052] Figure 10 This is a schematic diagram of adjusting the opening and closing angle of the clamping portion according to one embodiment of the present utility model;

[0053] Figure 11 is an enlarged schematic diagram of the clamping structure of the heart valve clamping device according to one embodiment of the present utility model;

[0054] Figure 12 is a partial schematic diagram of a clamping portion of a heart valve clamping device according to another embodiment of the present invention;

[0055] Figure 13 yes Figure 12 A schematic side view of the clamping portion;

[0056] Figure 14 This is a schematic diagram of the assembly of the first clamping member and the second clamping member according to another embodiment of the present utility model.

[0057] Description of reference numerals:

[0058] 101-second clamping member, 102-first clamping member, 103-one end of the support part, 104-support part, 105-the other end of the support part, 106-adjusting seat, 107-flexible member, 108-fixed shaft, 201-rotating shaft, 202-one end of the clamping part, 301-leaf, 401-driving shaft, 402-driving rod, 403-dissociation rod, 501-connecting hole, 601-blocking ring, 602-limiting pin, 603-rotating part, 701-wavy line, 801-connecting wire, 901-barb, 1101-buckle, 1102-slot, 1201-first connecting part. DETAILED DESCRIPTION

[0059] The following description of exemplary embodiments of the present invention is made in conjunction with the accompanying drawings, which include various details of the embodiments of the present invention to facilitate understanding. These details should be considered as merely exemplary. Therefore, those skilled in the art will recognize that various changes and modifications may be made to the embodiments described herein without departing from the scope and spirit of the present invention. Similarly, for the sake of clarity and conciseness, descriptions of well-known functions and structures are omitted in the following description.

[0060] The terms used in this application are for the purpose of describing specific embodiments only and are not intended to limit this application. As used in this application and the appended claims, the singular forms "a," "an," "the," and "the" are intended to include the plural forms, unless the context clearly indicates otherwise. It should also be understood that the term "and / or" as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items.

[0061] It should be understood that although the terms first, second, third, etc. may be used in this application to describe various information, such information should not be limited to these terms. These terms are merely used to distinguish information of the same type from one another. For example, first information may also be referred to as second information, and similarly, second information may also be referred to as first information, without departing from the scope of this application. Depending on the context, the term "if" as used herein may be interpreted as "when," "when," or "in response to determining."

[0062] As described in the background section, clamping devices are often used in the related art to clamp the leaflets to prevent the formation of regurgitation. However, such devices have many problems, such as leaflet tearing and clip detachment after implantation. Specifically, the clamping structure in the related art includes a clamping arm and a clamping member. The two are separate structures and are installed independently of each other. As a result, the clamping arm and the clamping member have different pivot points and completely different motion trajectories in space. As a result, when the clamping arm and the clamping member pivot, the clamping arm and the clamping member move asynchronously and experience significant relative motion. The distance between the clamping arm and the clamping member also changes continuously. For example, the myocardium continuously contracts and relaxes, pulling on the leaflets. The leaflets pull on the clamping structure, causing the clamping arms in the clamping structure to move away from the clamping members in the clamping structure, increasing the distance between the clamping arms and the clamping member and reducing the clamping force of the clamp. When the clamp design makes the clamping force unable to resist the pulling force of the leaflets, the leaflets will detach from the clamp, causing the clamp to detach and fail. At the same time, during the repeated pulling of the leaflet, the clamping arm repeatedly fits in and moves away from the clamping piece, and the barbs on the clamping piece insert into the leaflet. During the repeated pulling of the leaflet, the clamping piece will repeatedly insert into and move away from the leaflet, causing the leaflet to tear or even cause the leaflet to detach from the clamp.

[0063] To address the above-mentioned technical problems, the present invention provides a heart valve clamping device, comprising: a fixed shaft; a clamping portion, one end of which is pivotally connected to the fixed shaft; and an adjustment seat, which can move toward or away from the fixed shaft to adjust the opening and closing angle of the clamping portion. The clamping portion comprises a first clamping member and a second clamping member, the first clamping member and the second clamping member being connected by a flexible member; wherein the flexible member is bendable to cause the second clamping member to abut against the first clamping member.

[0064] like Figures 1 to 7 In the embodiment shown, the main body of the heart valve clamping device includes a fixed shaft 108, a clamping portion and an adjustment seat 106. One end 202 of the clamping portion is pivotally connected to the fixed shaft 108. For example, a mounting portion and a rotating shaft can be provided on the fixed shaft to rotatably connect the end of the clamping portion to the rotating shaft. Of course, there are usually two clamping portions, which are symmetrically arranged so as to clamp the edges of the two leaflets at the same time. The adjustment seat can move closer to or away from the fixed shaft to adjust the opening and closing angles of the clamping portion. Figure 1In the embodiment shown, the drive mechanism can be used to control the adjustment seat to move in a direction away from the fixed axis, so that the adjustment seat drives the clamping portion to move and rotate in a direction away from the fixed axis, thereby increasing the angle between the two clamping portions. On the contrary, when the drive mechanism is used to control the adjustment seat to move in a direction close to the fixed axis, the adjustment seat drives the clamping portion to rotate and rotate in a direction close to the fixed axis, thereby reducing the angle between the two clamping portions. Advantageously, by reasonably adjusting the opening and closing angles, it is convenient for the operator to control the instrument and improve operational efficiency. For example, when the operator retracts the instrument when he thinks the surgical effect is not good, the large opening and closing angle can reduce the risk of the clamping portion hooking the tendon cord, thereby improving surgical safety and fault tolerance. When the clamping effect meets the requirements, the operator can retract the clamping portion to reduce the space occupied by the instrument in the human body, thereby improving safety. In some embodiments, such as Figure 10 As shown, the two clamping parts can maintain a large opening and closing angle, for example, an angle of 270°-360° is formed between the two clamping parts, which effectively reduces the overall width of the clamping part and reduces the possibility of hooking the leaflet chordae tendineae when the instrument is retracted. Furthermore, the clamping part includes a first clamping member 102 and a second clamping member 101, and the first clamping member and the second clamping member are connected by a flexible member 107; wherein the flexible member can be bent so that the second clamping member and the first clamping member abut against each other. Figure 5 In the embodiment shown, the first clamping member and the second clamping member are connected as a whole, so that when the clamping portion rotates, the first clamping member and the second clamping member will move synchronously, the movement trajectories of the two in space are highly overlapped, and the distance between the two does not change significantly with the heart beating process. In this case, when the leaflet pulls the clamping portion to move or rotate, the synchronous movement of the first clamping member and the second clamping member will prevent the leaflet from sliding between the two clamping portions, thereby ensuring a stable clamping force and preventing the leaflet from detaching from the clamping portion. Figures 3 to 6 As shown, in the clamping state, the leaflet 301 is clamped between the first clamping member and the second clamping member. At this time, the first clamping member and the second clamping member abut against each other to provide a stable clamping force on the leaflet. Due to the presence of the flexible member 107, the second clamping member can be bent nearly 180 degrees to abut against the first clamping member.

[0065] In an optional embodiment, the device further comprises a support portion, one end of the support portion being pivotally connected to the adjustment seat and the other end being pivotally connected to the middle portion of the first clamping member. In an optional embodiment, the support portion is made of an elastic material and can be compressed or extended in response to the pivotal movement of the clamping portion.

[0066] like Figure 1In the embodiment shown, the support portion 104 is in a wavy shape, so that it has good elasticity. Furthermore, the support portion can also be made of elastic material, especially superelastic material, such as nickel-titanium alloy, so that it maintains good compression and extension properties. Furthermore, one end 103 of the support portion is pivotally connected to the middle part of the first clamping member, for example, through a rotating shaft 201, and the other end 105 is pivotally connected to the adjustment seat. The pivot connection allows the adjustment seat 106 to move away from and toward the fixed axis 108. The driving force can be transmitted to the clamping portion in sequence through the adjustment seat and the support portion 104, thereby driving the clamping portion to rotate around the hinge axis between it and the fixed axis. In addition, the support portion can also adapt to the pulling force of the leaflets on the clamping portion during the heart beat. Specifically, the elastic material of the support portion allows it to withstand large deformation and provide stable support force, thereby achieving the clamping repair device to adapt to the tension of the native leaflets. When the heart is in diastole, the leaflets are subjected to a greater pulling force, the deformation of the support portion increases, and the clamping portion moves in the direction away from the main body of the clamping repair device as the support portion deforms, thereby adapting to the pulling of the leaflets and reducing the clamping force required to overcome the greater pulling of the leaflets, avoiding the risk of leaflets falling off or tearing; and when the heart is in contraction, the leaflets are subjected to a smaller pulling force, the deformation of the support portion decreases, and the clamping portion moves in the direction close to the main body of the clamping repair device as the deformation of the support portion recovers, thereby adapting to the pulling of the leaflets. It can be seen from the above description that: because the support portion adapts to the pulling of the leaflets, the clamping portion can provide a stable clamping force for the leaflets, and the leaflets clamped in the middle of the clamping portion and the clamping portion, especially the barb 901 on its second clamping member (see Figure 9 ) are stable, and their relative positions do not change with the beating of the heart, and the risk of the barbs tearing the valve leaflets is significantly reduced.

[0067] In an optional embodiment, the first clamping member, the second clamping member and the flexible member are an integrated component; or, the second clamping member and the flexible member are an integrated component, and the end of the flexible member away from the first clamping member is detachably connected to the first clamping member; or, the first clamping member, the second clamping member and the flexible member are all independent components, and the first clamping member and the second clamping member are connected via a flexible member.

[0068] like Figures 1 to 9 In the embodiment shown, the first clamping member, the second clamping member and the flexible member are integrated components to avoid problems with the connection of parts, so that the structural strength of the clamping portion is high and it is easy to manufacture. Figure 12 and 13As shown, the second clamping member and the flexible member can be provided as an integrated component, and a first connecting portion 1201 can be provided at one end of the flexible member away from the second clamping member to be assembled with the second connecting portion of the first clamping member. One of the first connecting portion and the second connecting portion is a buckle, and the other is a slot, thereby realizing a snap connection between the two. Furthermore, the flexible member can be bent so that the two ends of the flexible member are parallel to each other or close to each other. Preferably, the close proximity only indicates that there is a tendency for the two to approach each other, but not to abut against each other. It can be understood that in order to improve the connection strength, two sets of connecting portions 1201 can be provided on the second clamping member, and a corresponding second connecting portion can be provided on the first clamping member shown, thereby realizing the connection between the first clamping member and the second clamping member. Specifically as shown Figure 14 As shown, it shows the installation state of the connecting part 1201 and the first clamping part. In this embodiment, the surfaces opposite to the first clamping part and the second clamping part are planes to reduce the damage to the leaflets during the clamping process. It should be noted that, in practice, the requirements for the manufacturing materials used for the first clamping part, the second clamping part and the flexible part are different. In particular, the second clamping part and the flexible part usually need to be made of memory alloy. Therefore, the use of such a split structure design component can take into account the difficulty of processing and connection, while also reducing the amount of special materials used and reducing production costs. In other embodiments, the three components can be further set as split structures, and then the components can be connected to form a complete clamping part. For example, the various parts can be fixedly connected by welding or other means.

[0069] In an optional embodiment, the flexible member includes a hollow structure; and / or at least a portion of the clamping portion is made of a memory alloy.

[0070] like Figure 7 In the structure shown, the flexible part includes a hollow structure to improve its flexibility. This design can also further reduce the stress concentration problem during the repeated bending of the flexible part, thereby improving the service life and reliability of the clamping part. Specifically, a wavy connecting structure can be provided in the flexible part to form the hollow structure. The wavy metal lines can be formed by laser cutting process. Figure 7In the illustrated embodiment, the wavy connectors, such as the wavy lines 701, are independent of each other and do not have any coupling effect with each other. In other embodiments, reinforcement members, such as connecting wires 801, may be added between the wavy connectors to improve the overall structural strength of the flexible member. In other embodiments, the clamping portion is at least partially made of a memory alloy. For example, the flexible member is made of a memory alloy, or both the flexible member and the second clamping portion are made of a memory alloy. The memory alloy makes the second clamping member and the flexible member tend to maintain a folded shape, so that the second clamping member can stably rest against the first clamping member and provide a stable and sufficient clamping force for the leaflet. Figure 9 The figure shows that in the initial state, the second clamping member is pressed against the first clamping member under the bending of the flexible member. Due to the inherent properties of the memory alloy, when the leaflet needs to be clamped inside the clamping portion, the first clamping member and the second clamping member need to be separated first. Specifically, Figure 5 As shown, a connection hole 501 can be provided on the second clamping member, and a pull wire in the delivery system is passed through the connection hole to pull the second clamping member, causing the second clamping member to rotate relative to the first clamping member. In practice, when it is necessary to clamp the leaflet, it is only necessary to pull the second clamping member away from the first clamping member via the pull wire, and adjust the position and posture of the device so that the leaflet is between the first and second clamping members. Then, the pull wire is released, and the properties of the memory alloy are utilized to move the second clamping member closer to the first clamping member to clamp the leaflet.

[0071] In an optional embodiment, barbs are provided on the surface of the second clamping member facing the first clamping member.

[0072] like Figure 9 As shown, after the leaflet is clamped, the clamping stability of the leaflet can be further improved by the barbs 901 on the second clamping member. The barbs protrude from the second clamping member in the direction of the first clamping member. In some preferred embodiments, in the initial state, the barbs penetrate into the hollow portion of the first clamping member. As mentioned above, the clamping portion in the present invention can provide a stable clamping force. Therefore, compared with the prior art, only fewer barbs are needed to anchor the leaflet in this embodiment to ensure the stability of the leaflet clamping. More advantageously, fewer barbs can reduce the risk of barbs damaging the leaflet during the release and re-implantation of the clamping repair device, improve the safety and success rate of the operation, and reduce the risk of barbs tearing the leaflet during heart beating.

[0073] In an optional embodiment, in an initial state, the first clamping member and the second clamping member are arranged in parallel or at a negative angle.

[0074] In practice, the first clamping member and the second clamping member can be kept in a parallel state to provide a stable clamping force for the leaflet. Especially when the bending radius of the flexible member is small, or the setting of the barb structure can ensure the stability of the leaflet clamping and solve the problem of the clamping part and the leaflet being separated. Of course, a certain negative angle can also be formed between the first clamping member and the second clamping member to increase the clamping force of the second clamping member on the leaflet. Figure 9 The negative angle shown can be understood as the second clamping member being bent further toward the first clamping member from its initial position relative to the first clamping member, forming a layout similar to structural interference. In other words, the extended surfaces of the two sides of the bent section of the flexible member intersect to form the negative angle.

[0075] In an optional embodiment, a drive shaft is further included, which is arranged inside the fixed shaft, and the outer surface of the drive shaft is threadedly engaged with the inner surface of the fixed shaft; the end of the drive shaft away from the fixed shaft is limitedly connected to the adjustment seat, and the limit connection limits the axial movement of the drive shaft relative to the adjustment seat.

[0076] like Figure 4 In the embodiment shown, the clamping device further includes a drive shaft 401. The drive shaft is connected to a driving member, and the rotation of the drive shaft is controlled by the driving member. Furthermore, the outer surface of the drive shaft is provided with an external thread, the fixed shaft has a through hole extending along its own axis, and the end of the through hole is provided with an internal thread, and the external thread and the internal thread cooperate to achieve a threaded connection between the drive shaft and the fixed shaft. The driving member can drive the drive shaft to rotate, so that the drive shaft rotates and moves axially relative to the fixed shaft, thereby changing the position of the drive shaft relative to the fixed shaft. Furthermore, the end of the drive shaft located in the adjustment seat is subject to the limiting effect of the adjustment seat. The limiting effect only limits the displacement of the drive shaft in the axial and radial directions, but does not limit its rotation. This arrangement allows the drive shaft to rotate in the adjustment seat and drive the axial movement of the adjustment seat relative to the fixed shaft, and then drives the clamping part to rotate relative to the fixed shaft through the support part, so as to achieve the purpose of adjusting the opening and closing angle of the clamping part. As Figure 6 In the illustrated embodiment, the drive shaft comprises two parts: a rotating portion 603 and a driving portion. The rotating portion rotates within the adjustment seat without axial movement, while the driving portion rotates and moves axially relative to the fixed shaft. The portion of the driving portion proximal to the rotating portion has external threads, while the end distal to the rotating portion is provided with a connecting portion for connection to the driver.

[0077] In an optional embodiment, a retaining ring is provided at one end of the adjustment seat and a limiting pin is provided at the other end, and the end of the drive shaft away from the fixed shaft is limited between the retaining ring and the limiting pin.

[0078] like Figure 6 In the illustrated embodiment, the adjustment seat includes a retaining ring 601. The retaining ring has an inner diameter smaller than the outer diameter of the rotating portion 603, thereby preventing the drive shaft from separating from the adjustment seat after passing through the inner hole of the adjustment seat. Furthermore, the adjustment seat is provided with a limit pin 602, which holds the rotating portion in place between the retaining ring and the retaining ring.

[0079] In an optional embodiment, a driving member is further included, and the driving member is connected to the end of the driving shaft away from the adjustment seat, and the driving member is used to control the movement state of the driving shaft. In an optional embodiment, the driving member includes a driving rod and a disengagement rod, wherein the driving rod is engaged and connected with the driving shaft; the driving rod includes a through hole extending along the axis of the driving rod, and the disengagement rod is arranged in the through hole and is detachably connected to the driving shaft to control the engagement or separation state between the driving rod and the driving shaft. In an optional embodiment, at least one of the driving shaft and the driving rod is provided with a card slot, and the other is provided with a buckle, and the card slot and the buckle cooperate to engage and connect the driving rod with the driving shaft.

[0080] like Figure 4 and Figure 10 In the embodiment shown, the driving member includes a driving rod 402 and a dissociation rod 403. A blind hole is provided on the end of the driving shaft 401 that cooperates with the dissociation rod, and an internal thread is provided in the blind hole. Correspondingly, the end of the dissociation rod is provided with an external thread to cooperate with the internal thread, thereby forming a detachable connection between the dissociation rod and the driving shaft. Furthermore, the driving rod is sleeved on the outside of the dissociation rod, and the end thereof is detachably connected to the driving shaft. Specifically, as Figure 11 As shown, draw-in groove 1102 can be set on described drive shaft 401, and buckle 1101 can be set on the end of described drive rod, and the cooperation of described draw-in groove and buckle realizes the detachable connection between the two. The arrangement mode of described draw-in groove and buckle is only a kind of exemplification, and in practice, buckle can be set on drive shaft, and draw-in groove is set on drive rod. It should be noted that when buckle cooperates with draw-in groove, it is also subject to the constraint of dissociation rod. Concrete, when dissociation rod exists, the outer wall of described dissociation rod will constrain the relative motion between buckle and draw-in groove, thereby avoids disengaging between the two. Only when dissociation rod is evacuated, can free separation be achieved between described buckle and draw-in groove.

[0081] In some embodiments, the outer diameter of the driver connected to the drive shaft is smaller than the diameter of the internal threads of the fixed shaft, allowing the driver to move freely forward and backward along the inner bore of the fixed shaft. In this case, when the clamping portion is opened to a large angle, the drive shaft will disengage from the fixed shaft. The driver can then quickly change the position of the adjustment seat, thereby quickly adjusting the opening and closing angle of the clamping portion. In some embodiments, when the clamping portion has clamped the leaflets, the threads of the drive shaft and the threads of the fixed shaft form a self-locking lock, thereby preventing the clamping portion from opening. At this point, the driver's disengagement rod and the drive rod can be disconnected from the drive shaft in sequence. As can be seen from the above description, the driver and the drive shaft of the present invention jointly control the opening and closing state of the clamping portion. Once the clamping portion has stably clamped the leaflets, the driver can be removed, allowing the drive shaft to self-lock with the fixed shaft to ensure the clamping function of the device. This reduces the weight of the device remaining in the human body, reduces the risk of leaflet tearing due to excessive clamping weight, and improves the safety and reliability of the device. Furthermore, in the clamped state, the clamping portion is in a retracted state, making the overall structure of the device smaller.

[0082] The above specific embodiments do not constitute a limitation on the scope of protection of the present utility model. After considering the specification and practicing the technical solutions disclosed in this application, those skilled in the art will easily think of other embodiments of the present disclosure. This application is intended to cover any variations, uses or adaptive changes of the present disclosure, which follow the general principles of the present disclosure and include common knowledge or customary technical means in the art that are not disclosed in this disclosure. The description and examples are to be regarded as exemplary only, and the true scope and spirit of the present disclosure are indicated by the following claims.

[0083] It should be understood that the present disclosure is not limited to the exact structures that have been described above and shown in the drawings, and that various modifications and changes can be made without departing from the scope thereof. The scope of the present disclosure is limited only by the appended claims.

Claims

1. A heart valve clamping device, characterized in that: include: Fixed axis; a clamping portion, one end of which is pivotally connected to the fixed shaft; An adjustment seat, which can move closer to or away from the fixed axis to adjust the opening and closing angle of the clamping portion; The clamping portion includes a first clamping member and a second clamping member, wherein the first clamping member and the second clamping member are connected by a flexible member; wherein the flexible member can be bent so that the second clamping member and the first clamping member abut against each other; The flexible member includes a hollow structure; In the initial state, the first clamping member and the second clamping member are arranged in parallel or at a negative angle.

2. The heart valve clamping device according to claim 1, characterized in that: It also includes a supporting portion, one end of which is pivotally connected to the adjusting seat, and the other end of which is pivotally connected to the middle portion of the first clamping member.

3. The heart valve clamping device according to claim 2, characterized in that: The supporting portion is made of elastic material and can be in a compressed state or an extended state as the clamping portion pivots.

4. The heart valve clamping device according to claim 1, wherein: The first clamping member, the second clamping member and the flexible member are an integrated component; or, The first clamping member, the second clamping member and the flexible member are all independent components, and the first clamping member and the second clamping member are connected through the flexible member.

5. The heart valve clamping device according to claim 4, characterized in that: At least a portion of the clamping portion is made of memory alloy.

6. The heart valve clamping device according to claim 1, characterized in that: The surface of the second clamping piece facing the first clamping piece is provided with barbs.

7. The heart valve clamping device according to claim 1, characterized in that: It also includes a driving shaft, wherein the driving shaft is arranged inside the fixed shaft, and the outer surface of the driving shaft is threadedly engaged with the inner surface of the fixed shaft; The end of the driving shaft away from the fixed shaft is connected to the adjustment seat in a limiting manner, and the limiting connection limits the axial movement of the driving shaft relative to the adjustment seat.

8. The heart valve clamping device according to claim 7, characterized in that: One end of the adjustment seat is provided with a retaining ring, and the other end is provided with a limiting pin, and the end of the driving shaft away from the fixed shaft is limited between the retaining ring and the limiting pin.

9. The heart valve clamping device according to claim 7, characterized in that: It also includes a driving member, which is connected to the end of the driving shaft away from the adjustment seat, and is used to control the movement state of the driving shaft.

10. The heart valve clamping device according to claim 9, characterized in that: The driving member includes a driving rod and a dissociation rod, wherein The driving rod is engaged with the driving shaft; The driving rod includes a through hole extending along the axis of the driving rod. The dissociation rod is arranged in the through hole and is detachably connected to the driving shaft to control the engagement or separation state between the driving rod and the driving shaft.

11. The heart valve clamping device according to claim 10, characterized in that: At least one of the driving shaft and the driving rod is provided with a slot, and the other is provided with a buckle, and the slot and the buckle cooperate to enable the driving rod to be engaged and connected with the driving shaft.

12. A detachable clamping unit for a heart valve clamping device, characterized in that: include: The second clamping member and the flexible member are integrated components. The flexible member can be bent so that the two ends of the flexible member are parallel to each other or close to each other.

13. The detachable clamping unit according to claim 12, characterized in that: The flexible member includes a wave-shaped connecting member, and / or a reinforcing member is provided between the wave-shaped connecting members.

14. A heart valve clamping device, characterized in that: include: Fixed axis; a clamping portion, one end of which is pivotally connected to the fixed shaft; An adjustment seat, which can move closer to or away from the fixed axis to adjust the opening and closing angle of the clamping portion; The clamping portion includes a first clamping member and the detachable clamping unit according to claim 12 or 13, and the end of the flexible member away from the second clamping member is detachably connected to the first clamping member; The flexible member can be bent so that the second clamping member and the first clamping member abut against each other.

15. The heart valve clamping device according to claim 14, characterized in that: The end of the flexible member away from the second clamping member is provided with a first connecting portion, the first clamping member is provided with a second connecting portion, and the first connecting portion is detachably connected to the second connecting portion.

16. The heart valve clamping device according to claim 15, characterized in that: One of the first connecting portion and the second connecting portion is a buckle, and the other is a slot.

17. The heart valve clamping device according to claim 14, wherein: The flexible member includes a hollow structure; and / or at least a portion of the clamping portion is made of a memory alloy.

18. The heart valve clamping device according to claim 17, characterized in that: In the initial state, the first clamping member and the second clamping member are arranged in parallel or at a negative angle.

Images