Artificial leaflet device to improve heart valve coaptation

Abstract

The present application relates to the field of medical devices, and in particular to an artificial leaflet device for improving the engagement of a heart valve, comprising a fixed frame, a coapting leaflet, a fixed needle, and a limiting wire, wherein the fixed frame is coated with a fabric layer, the fixed frame is anchored to an autologous valve ring or atrial tissue through the fixed needle, one end of the limiting wire is connected to the coapting leaflet, and the other end of the limiting wire is fixed to chordae tendineae or papillary muscles, and a fitting device is arranged on the fixed frame, the fitting device comprises a threaded needle and a lower pressing plate, wherein the lower pressing plate is located in the middle area of ​​the coapting leaflet, when implanted, the threaded needle passes through the fabric layer on the fixed frame and penetrates into the atrial tissue, the lower pressing plate is closely attached to the middle area of ​​the coapting leaflet and makes the middle area of ​​the coapting leaflet closely attached to the atrial tissue or the autologous valve leaflet; the present invention can effectively avoid gaps between the closing aid and the autologous valve leaflet, avoid blood leakage from both sides of the coapting leaflet, thereby effectively avoiding blood reflux, and has good clinical significance.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to an artificial leaflet device for improving coaptation of heart valves. Background Art

[0002] The mitral valve is located at the left atrioventricular orifice and is composed of five parts: the valve ring, valve leaflets, chordae tendineae, papillary muscles, and commissural connections. Its accurate anatomical name is the mitral apparatus (mitral apparatus) or mitral complex (mitral complex).

[0003] The tricuspid valve is located at the right atrioventricular orifice and has three nearly triangular sail-shaped valves. The base of the valve is attached to the fibrous ring of the atrioventricular orifice. Functionally, the fibrous ring, valve, chordae tendineae and papillary muscles can be seen, forming the tricuspid valve complex (tricuspidvalvarcomplex).

[0004] Mitral regurgitation can be divided into the following two types: 1. Rheumatic mitral regurgitation, mainly caused by mitral valve insufficiency, can cause blood to flow in reverse, thereby mixing different bloods, causing the heart to pump blood and oxygen delivery function to decline. 2. Non-rheumatic mitral regurgitation, usually refers to mitral regurgitation of varying degrees caused by abnormalities of the mitral valve itself and its surrounding anatomical structures in addition to rheumatic valvular disease. There are many causes of non-rheumatic mitral regurgitation, the more common ones are: mitral valve prolapse, papillary muscle insufficiency or chordae tendineae rupture, left atrial myxoma, valve ring calcification, congenital valve malformation, infective endocarditis, etc. Mitral regurgitation can also be divided into three types: functional, degenerative or mixed. The most common are degenerative and functional mitral regurgitation. Functional mitral regurgitation is generally secondary to impaired left ventricular wall motion, left ventricular dilatation, and papillary muscle dysfunction, and is generally seen in patients with heart failure. This group of patients also includes ischemic mitral regurgitation secondary to coronary artery disease and mitral regurgitation associated with non-ischemic cardiomyopathy. Degenerative mitral regurgitation disease is generally considered to be a pathological change in the valve structure or pathological changes in the subvalvular structure, including abnormal extension or rupture of the chordae tendineae.

[0005] When we use a treatment method of leaflet repair or replacement of a single autologous leaflet, we usually choose to repair or replace the posterior leaflet so that the implanted artificial leaflet can be aligned with the anterior leaflet. For example, patent CN202210058417.8 discloses a repair device with a bionic leaflet morphology, including a first skeleton and a closing aid. After the repair device is implanted, the first skeleton is fixed on the autologous valve annulus or atrial tissue, and the closing aid can move with the movement of the autologous valve leaflet. The repair device also includes a shape retaining member, one end of the shape retaining member is connected to the first skeleton, and the shape retaining member is attached to the closing aid. When the autologous valve is in a closed state, the part of the closing aid close to the autologous valve annulus is supported by the shape retaining member. Although the shape retaining member in the patent solution can provide effective shape support for the upper part of the closing aid, due to the lack of visibility during the surgical operation and the limited space for minimally invasive surgery, its first skeleton is difficult to be anchored close to the native valve ring. The fixed position of the first skeleton is usually above the native valve ring, which will cause a partial gap between the root area of ​​the closing aid and the root area of ​​the native valve ring. When the valve is closed, blood will flow into this space and further flow out to both sides of the closing aid, causing blood reflux. In addition, long-term blood accumulation will also cause calcification, thrombosis and other problems in this area.

[0006] Patent No. US15453518 discloses a prosthetic heart valve for treating diseased heart valves, the valve having natural anterior and posterior leaflets, the leaflets moving between an open position and a closed position to regulate the blood flow through the heart valve during the cardiac cycle of the heart. The artificial heart valve has a crescent-shaped stent, at least one artificial leaflet mounted on the inner surface of the stent, and at least one fork-shaped structure coupling a portion of the at least one artificial leaflet to the lower ventricular portion of the stent frame. The patent scheme adopts a method of pre-shaping the artificial leaflet, which can observe the patient's valve morphology through images before surgery, and formulate the shaping morphology of the artificial leaflet according to the patient's valve morphology, but this method needs to be reserved in advance for the patient to fit the patient's autologous leaflet, and its production cycle is long and the cost is high, making it difficult to promote commercialization; and the crescent-shaped stent fixation also has the problem of not being able to fit tightly with the autologous valve ring, resulting in a certain gap between the artificial leaflet and the root area of ​​the autologous leaflet, and this gap will also cause blood infiltration, and adverse conditions such as thrombosis will occur after long-term implantation.

[0007] In summary, the repair devices in the prior art have at least the following technical pain points: due to the fact that minimally invasive surgical operations are not visual, it is difficult to perfectly fit the fixed frame (the stent connected to the artificial leaflet) to the native valve ring only through images and its delivery system. Usually, the fixed frame is fixed above the native valve ring, which results in a gap space between the root area of ​​the artificial leaflet and the native valve ring. When the valve opens and closes, part of the blood will seep into this area, causing the blood accumulated in the root area to flow out from the two sides of the root of the closing aid, causing paravalvular leakage and affecting the repair effect. Summary of the invention

[0008] This application is proposed in view of the above and other more concepts.

[0009] One of the purposes of the present application is to overcome the deficiencies of the prior art, and to provide an artificial leaflet device for improving the coaptation of a heart valve, in order to address the problem of blood flow infiltration between the roots of the apposed leaflets and the roots of the native leaflets in the prior art, causing paravalvular leakage on both sides.

[0010] The technical solution adopted to solve the technical problem of the present invention is to provide an artificial leaflet device for improving the engagement of a heart valve, comprising a fixed frame, a coapting leaflet connected to the fixed frame, a fixing needle, and a limiting wire, wherein the fixed frame is covered with a fabric layer, and the fixed frame is anchored to the autologous valve ring or atrial tissue through the fixing needle, one end of the limiting wire is connected to the coapting leaflet, and the other end of the limiting wire is fixed to the chordae tendineae tissue or the papillary muscle, and a fitting device is provided on the fixed frame, and the fitting device comprises a threaded needle and a lower pressing plate connected to the threaded needle, wherein the lower pressing plate is located in the middle area of ​​the coapting leaflet, and when implanted, the threaded needle passes through the fabric layer on the fixed frame and penetrates into the atrial tissue, and the lower pressing plate is closely attached to the middle area of ​​the coapting leaflet and makes the middle area of ​​the coapting leaflet closely attached to the atrial tissue or the autologous valve leaflet.

[0011] As a further improvement of the present invention, the apposed leaves are made of biological materials (such as bovine pericardium or porcine pericardium), and of course, they can also be made of polymer materials.

[0012] As a further improvement of the present invention, the longer the stroke of the threaded needle piercing the atrial tissue is, the shorter the distance between the lower pressing plate and the atrial wall or the native valve leaflet is.

[0013] As a further improvement of the present invention, the operator can adjust the downward pressure of the lower pressure plate by adjusting the stroke length of the threaded needle in the atrial tissue with the help of images. When different operators operate the anchoring fixation frame, the height of the anchoring position is different. The threaded needle can also be adjusted to reduce or eliminate the gap between the middle area of ​​the apposed leaflet and the native valve leaflet, thereby greatly increasing the fault tolerance of the device. Similarly, in the face of differences in physiological and anatomical structures between different patients, the threaded needle can also be adjusted to effectively reduce blood congestion between the apposed leaflet and the native valve leaflet.

[0014] As a further improvement of the present invention, since it is not visible during the operation, the position of the fixing needle may be on the atrial wall, resulting in a certain height difference between the root of the apposed leaflet and the native valve ring, creating a layer space in which blood will accumulate. Therefore, the lower pressing plate is a hard part with a certain rigidity, so that the lower pressing plate can press down the middle area of ​​the apposed leaflet close to the native valve ring (the middle area is the main area for blood reflux), so that the middle area of ​​the apposed leaflet can be close to the heart tissue, preventing a large amount of blood from entering between the apposed leaflet and the native valve leaflet.

[0015] As a further improvement of the present invention, the lower pressing plate is connected to the fabric layer of the fixed frame by means of a stitch on one side.

[0016] As a further improvement of the present invention, the lower pressing plate includes a woven mesh with a rectangular structure and a biomaterial coated on the woven mesh, wherein the woven mesh is woven with memory metal wire, and the biomaterial can be bovine pericardium or porcine pericardium. The lower pressing plate is fixed to the fabric layer by sutures on one side of the fixed frame. When we operate the threaded needle to advance toward the atrial tissue, the lower pressing plate will move the middle area of ​​the apposed leaves toward the atrial tissue like a hinge.

[0017] As a further improvement of the present invention, a connecting hole is provided on the lower pressing plate, and a groove matching the connecting hole is provided at the tail of the threaded needle, so that the threaded needle is sleeved on the lower pressing plate. Since the lower pressing plate is rectangular in shape, one side of the lower pressing plate is fixed to the fabric layer by means of stitches. Therefore, when the operator operates and rotates the threaded needle, the lower pressing plate will not rotate circumferentially.

[0018] As a further improvement of the present invention, an anti-wrinkle rod is arranged on the opposing blades, and the anti-wrinkle rod is arranged on the opposing blades, wherein the anti-wrinkle rod divides the opposing blades into an upper area and a lower area, wherein the lower pressure plate is located in the upper area.

[0019] As a further improvement of the present invention, the anti-wrinkle rod is a rod made of memory metal material.

[0020] As a further improvement of the present invention, according to clinical anatomical knowledge, when the autologous valve is closed, the two-thirds of the lower part of the posterior leaflet is mainly in contact with the anterior leaflet. Therefore, we set the anti-wrinkle rod at the third part of the coapted leaflet, so that the axial length of the upper area accounts for one third of the axial length of the coapted leaflet. The purpose of this setting is to prevent the anti-wrinkle rod from interfering with and damaging the anterior leaflet when the valve is closed. Because the anti-wrinkle rod has a certain rigidity, if it touches the anterior leaflet when the leaflets are in contact, it will not only affect the coaptation effect, but also cause damage to the anterior leaflet after long-term implantation.

[0021] As a further improvement of the present invention, the anti-wrinkle rod is in an arched shape, and the anti-wrinkle rod makes the apposing leaflets in an arched shape (which can better simulate the shape of the native valve leaflets) so as to better mate with the native valve leaflets and prevent reflux. Moreover, the arched anti-wrinkle rod makes the upper area concave in the middle and bulging on both sides.

[0022] As a further improvement of the present invention, the middle region of the commissural leaflets is located in the P2 region of the native valve, and the width of the middle region is greater than or equal to the width of the P2 region of the native valve.

[0023] As a further improvement of the present invention, when the autologous valve is in a closed state, the left and right sides of the upper area fit the autologous leaflets, which makes the upper area of ​​the apposed leaflets present a shape with a concave middle and bulging on both sides, and the bulging sides on both sides fit the autologous leaflets. The purpose of this design is that when the valve is in a closed state, most of the blood flow at the posterior leaflet will impact the P2 area of ​​the autologous valve. We set the lower pressure plate to make the middle area of ​​the apposed leaflets close to the autologous leaflets to avoid blood infiltration between the apposed leaflets and the autologous leaflets, and to close the apposed leaflets. If the upper area of ​​the leaf is completely pressed down, the apposing leaflet will be over-pressed and cannot be completely apposed with the anterior leaflet, which will affect the shape of the apposing leaflet. Therefore, we choose to press down the middle area with a large blood flow impact and a large amount of blood. Since the blood flow impact is small and the blood volume is small in the areas on both sides, the bulges on both sides of the upper area are used to hold the blood to prevent the backflow of this part of the blood. In addition, the anti-wrinkle rod can maintain the arched shape of the apposing leaflet while preventing the bulges on both sides of the apposing leaflet from squeezing toward the middle area when the apposing leaflet is in apposition, causing the apposing leaf to deform and affecting the treatment effect.

[0024] As a further improvement of the present invention, the maximum width of the lower pressing sheet is less than or equal to two-thirds of the width of the upper region after unfolding.

[0025] Compared with the prior art, the advantages of the technical solution of the present application include at least the following:

[0026] 1. In the prior art, when the implant is anchored, the anchoring position of the fixing frame is generally higher than the native valve ring because the operation is not visible during the operation. This results in a gap between the root of the artificial valve leaflet and the root area of ​​the native valve leaflet, which causes blood to flow into the gap when the valve is closed, resulting in blood shunting from both sides of the closing aid, and adverse conditions such as valve reflux. According to one concept of the present application, a fitting device is provided in the upper area of ​​the apposing leaflet, and the fitting device is located in the middle area of ​​the apposing leaflet close to the native valve ring, so as to squeeze out the space between the root of the apposing leaflet and the root of the native valve ring, so that the root of the apposing leaflet can be close to the native valve ring or the atrial wall, effectively avoiding blood impact between the apposing leaflet and the native valve leaflet, avoiding reflux and thrombosis, etc., and the operator can also control the degree of downward pressure of the pressing plate by adjusting the stroke of the threaded needle inserted into the atrial tissue to adapt to the differences in physiological and anatomical structures between different patients, while also greatly improving the fault tolerance of the device and greatly increasing its clinical treatment success rate.

[0027] 2. According to one concept of the present application, the lower pressing plate is a hard part with a rectangular structure design, one side of which is connected to the fabric layer of the fixed frame by means of sutures, so that when the operator manipulates the rotating threaded needle, the lower pressing plate will not rotate, and pressure is applied to the apposing leaflets in a manner similar to the closing of a hinge, so that the middle area of ​​the apposing leaflets can be close to the native leaflet.

[0028] 3. According to one concept of the present application, the anti-wrinkle rod divides the apposing leaflets into an upper area and a lower area, wherein the axial length of the upper area accounts for one third of the axial length of the apposing leaflets. The purpose of this arrangement is to prevent the anti-wrinkle rod from interfering with and damaging the front leaflet when the valve is closed. Because the anti-wrinkle rod has a certain rigidity, if it touches the front leaflet when the leaflets are in apposition, it will not only affect the apposition effect, but also cause damage to the front leaflet after long-term implantation.

[0029] 4. According to an idea of ​​the present application, the anti-wrinkle rod is in an arched shape. When the native valve is in a closed state, the left and right sides of the upper area fit the native valve leaflets, which makes the upper area of ​​the apposed leaflets present a shape with a concave middle and bulging on both sides, and the bulging sides on both sides fit the native valve leaflets. The purpose of this design is that when the valve is in a closed state, most of the blood flow at the posterior leaflet will impact the P2 area of ​​the native valve. We set the lower pressure plate to make the middle area of ​​the apposed leaflets close to the native valve leaflets to avoid blood infiltration between the apposed leaflets and the native valve leaflets, and the upper area of ​​the apposed leaflets If the entire upper area is pressed down, the apposing leaflets will be over-pressed and unable to fully appose with the anterior leaflet, which will affect the shape of the apposing leaflets. Therefore, we choose to press down the middle area with a large blood flow impact and a large amount of blood to eliminate most of the blood flow impact. In the areas on both sides, since the blood flow impact is small and the blood volume is small, the bulges on both sides of the upper area are used to hold the blood to prevent the blood from flowing back. In addition, the anti-wrinkle rod can maintain the arched shape of the apposing leaflets while preventing the bulges on both sides of the apposing leaflets from squeezing toward the middle area when the apposing leaflets are in apposition, causing the apposing leaflets to deform and affecting the treatment effect.

[0030] The embodiments of the present application can achieve other advantageous technical effects that are not listed one by one. These other technical effects may be partially described below and are predictable and understandable to those skilled in the art after reading the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The above-mentioned features and advantages and other features and advantages of these embodiments and the manner in which they are achieved will become more apparent, and the embodiments of the present application can be better understood by referring to the following description together with the accompanying drawings, in which:

[0032] Figure 1 Schematic diagram of the overall structure of the artificial leaflet device of the present invention.

[0033] Figure 2~Figure 5 This is a schematic diagram of the overall structure of the artificial leaflet device of the present invention positioned in the heart.

[0034] Figure 6 Schematic diagram of a natural mitral valve from above.

[0035] Figure 7 It is a top view schematic diagram of the artificial leaflet device of the present invention after implantation.

[0036] Figure 8 Schematic diagram of the upper region of the coinciding blades of the present invention.

[0037] Fig. 9 It is a schematic structural diagram of the lower pressing sheet in the present invention.

[0038] The features indicated by the numbers in the accompanying drawings are as follows:

[0039] 1-fixed frame, 2-combined blades, 21-middle area, 22-upper area, 23-lower area, 3-fixed needle, 4-limiting wire, 5-fabric layer, 6-fitting device, 61-threaded needle, 62-lower pressing plate, 621-connecting hole, 7-anti-wrinkle rod. DETAILED DESCRIPTION

[0040] In the following description of the drawings and specific embodiments, the details of one or more embodiments of the present application will be described. From these descriptions, drawings and claims, other features, purposes and advantages of the present application can be clearly seen.

[0041] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments may be other embodiments and may be implemented or executed in various ways. Each example is provided by explaining the disclosed embodiments rather than limiting them. In fact, it will be apparent to those skilled in the art that various modifications and variations may be made to the embodiments of the present application without departing from the scope or essence disclosed in the present application. For example, a feature illustrated or described as part of an embodiment may be used together with another embodiment to still produce another embodiment. Therefore, the present application discloses and covers such modifications and variations within the scope of the appended claims and their equivalent elements.

[0042] Likewise, it is understood that the phrases and terms used herein are for descriptive purposes and should not be considered restrictive. The use of "include," "comprise," or "have" and variations thereof herein is intended to be open-ended to include the items listed thereafter and their equivalents and additional items.

[0043] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the present application.

[0044] One of the purposes of the embodiments described below is to address the above-mentioned deficiencies, as well as other problems.

[0045] Embodiment 1

[0046] like Figure 1As shown, an artificial leaflet device for improving heart valve coaptation according to an embodiment of the present application is illustrated, comprising a fixing frame 1, coapting leaflets 2 connected to the fixing frame 1, fixing needles 3, and limiting wires 4, wherein the limiting wires 4 are wires made of PTFE or other materials, the fixing frame 1 is made of nickel-titanium alloy material, the fixing frame 1 is covered with a fabric layer 5, the fixing frame 1 is anchored to the autologous valve ring or atrial tissue through the fixing needles 3, one end of the limiting wire 4 is connected to the coapting leaflets 2, and the other end of the limiting wire 4 is fixed to the chordae tendineae tissue or the papillary muscle, and the limiting wire 4 is a wire made of PTFE or other materials, the fixing frame 1 is made of nickel-titanium alloy material, the fixing frame 1 is covered with a fabric layer 5, the fixing frame 1 is anchored to the autologous valve ring or atrial tissue through the fixing needles 3, one end of the limiting wire 4 is connected to the coapting leaflets 2, and the other end of the limiting wire 4 is fixed to the chordae tendineae tissue or the papillary muscle, The function of the wire 4 is to simulate the tendon tissue to adjust the shape of the apposed leaflet 2. A fitting device 6 is provided on the fixed frame 1, and the fitting device 6 includes a threaded needle 61 and a lower pressing plate 62 connected to the threaded needle 61, wherein the lower pressing plate 62 is located in the middle area 21 of the apposed leaflet 2. When implanted, the threaded needle 61 passes through the fabric layer 5 on the fixed frame 1 and penetrates into the atrial tissue (specifically the atrial wall tissue), and the lower pressing plate 62 is pressed against the middle area 21 of the apposed leaflet 2 and makes the middle area 21 of the apposed leaflet 2 close to the atrial tissue or the autologous leaflet. This allows the middle area 21 of the apposed leaflet 2 to be in close contact with the autologous leaflet, thereby preventing a large amount of blood flow from impacting between the apposed leaflet 2 and the autologous leaflet when the valve is closed, thereby shunting to both sides of the apposed leaflet 2, causing blood reflux; Figure 2 As shown, during the operation, the operator first delivers the artificial leaflet device to the left atrium through the delivery system matched with the artificial leaflet device, observes the relative position of the fixed frame 1 and the native valve ring through the image, and after finding the appropriate position (the appropriate position is usually that the fixed frame 1 is 5 mm above the native valve ring), anchors the fixed frame 1 to the atrial tissue through the fixing needle 3, and then observes the blood reflux volume on both sides of the coapted leaflets 2 through ultrasound images, as shown in FIG. Figure 3 and Figure 4 As shown, by operating the threaded needle 61, the lower pressing piece 62 makes the middle area 21 of the coapted leaflet 2 close to the native valve leaflet. When the blood backflow on both sides of the coapted leaflet 2 is observed to be very little or disappears, the threaded needle 61 is stopped and the delivery system is withdrawn from the body to complete the implantation. Figure 5 shown.

[0047] In this embodiment, the symmetric blades 2 are made of biological materials (such as bovine pericardium or porcine pericardium), and of course, they can also be made of polymer materials.

[0048] In this embodiment, the longer the threaded needle 61 penetrates into the atrial tissue, the shorter the distance between the lower pressing plate 62 and the atrial wall or the native valve leaflet. Figure 4As shown, when the threaded needle 61 is rotated, the needle tip of the threaded needle 61 pierces the atrial tissue, thereby driving the lower pressing plate 62 to move toward the atrial wall, so that the middle area 21 of the upper area 22 of the appositive leaflet 2 fits the native valve leaflet.

[0049] In this embodiment, with the help of images, the operator can adjust the downward pressure of the lower pressure plate 62 by adjusting the stroke length of the threaded needle 61 in the atrial tissue. When different operators operate the anchoring fixation frame 1, the height of the anchoring position is different. The threaded needle 61 can also be adjusted to reduce or eliminate the gap between the middle area 21 of the apposed leaflet 2 and the native valve leaflet, thereby greatly increasing the fault tolerance of the device. Similarly, in the face of differences in physiological and anatomical structures between different patients, the threaded needle 61 can also be adjusted to effectively reduce blood congestion between the apposed leaflet 2 and the native valve leaflet.

[0050] In this embodiment, since it is not visible during the operation, the position of the fixing needle 3 may be on the atrial wall, resulting in a certain height difference between the root of the apposed leaflet 2 and the native valve ring, creating a layer space, and blood will accumulate in this space. Therefore, the lower pressing plate 62 is a hard part with a certain rigidity, so that the lower pressing plate 62 can press down the middle area 21 of the apposed leaflet 2 close to the native valve ring (the middle area 21 is the main area for blood accumulation), so that the middle area 21 of the apposed leaflet 2 can be close to the heart tissue, preventing a large amount of blood from entering between the apposed leaflet 2 and the native valve leaflet.

[0051] In this embodiment, the lower pressing plate 62 is connected to the fabric layer 5 of the fixing frame 1 by means of a stitch on one side.

[0052] In this embodiment, the lower pressing plate 62 includes a woven mesh with a rectangular structure and a biological material coated on the woven mesh, wherein the woven mesh is woven with memory metal wire, and the biological material can be bovine pericardium or porcine pericardium. The lower pressing plate 62 is fixed to the fabric layer 5 by sutures on one side of the fixed frame 1. When we operate the threaded needle 61 to advance toward the atrial tissue, the lower pressing plate 62 will move the middle area 21 of the apposed blade 2 closer to the atrial tissue like a hinge.

[0053] In this embodiment, if Fig. 9 As shown, a connecting hole 621 is provided on the lower pressing plate 62, and a groove matching with the connecting hole 621 is provided at the tail of the threaded needle 61, so that the threaded needle 61 is sleeved on the lower pressing plate 62. Since the lower pressing plate 62 is rectangular in shape, one side of the lower pressing plate 62 is fixed to the fabric layer 5 by means of sutures. Therefore, when the operator operates and rotates the threaded needle 61, the lower pressing plate 62 will not rotate circumferentially.

[0054] In this embodiment, an anti-wrinkle rod 7 is provided on the opposing blades 2, and the anti-wrinkle rod 7 is provided on the opposing blades 2, wherein the anti-wrinkle rod 7 divides the opposing blades 2 into an upper area 22 and a lower area 23, wherein the lower pressure plate 62 is located in the upper area 22.

[0055] In this embodiment, the anti-wrinkle rod 7 is a rod made of memory metal material.

[0056] In this embodiment, according to clinical anatomical knowledge, when the native valve is closed, the two-thirds of the lower part of the posterior leaflet is mainly in contact with the anterior leaflet. Therefore, we set the anti-wrinkle rod 7 at the third part of the coapted leaflet 2, so that the axial length of the upper area 22 accounts for one third of the axial length of the coapted leaflet 2. The purpose of this setting is to prevent the anti-wrinkle rod 7 from interfering with and damaging the anterior leaflet when the valve is closed. Because the anti-wrinkle rod 7 has a certain rigidity, if it touches the anterior leaflet when the leaflets are in contact, it will not only affect the coaptation effect, but also cause damage to the anterior leaflet after long-term implantation.

[0057] In this embodiment, the anti-wrinkle rod 7 is in an arched shape, and the anti-wrinkle rod 7 makes the apposing leaflets 2 in an arched shape (which can better simulate the shape of the native valve leaflets) so as to better mate with the native valve leaflets and prevent reflux. In addition, the arched anti-wrinkle rod 7 makes the upper area 22 concave in the middle and bulging on both sides.

[0058] In this embodiment, the middle region 21 of the commissural leaflets 2 is located in the P2 region of the native valve (eg Figure 6 As shown, the posterior leaflet of the native valve is divided into P1, P2, and P3, wherein the P1 and P3 regions are close to the junction of the leaflets, and the P2 region is located in the middle of the posterior leaflet, wherein when the valve is closed, the P2 region is also the region with the largest blood flow and the strongest blood flow impact), and the width of the middle region 21 is greater than or equal to the width of the P2 region of the native valve.

[0059] In this embodiment, if Figure 7 As shown, when the apposition leaflet 2 and the autologous anterior valve leaflet are appositioned, the apposition leaflet 2 mainly uses the lower area 23 to apposition with the autologous anterior valve leaflet. Therefore, even if the middle area 21 of the upper area 22 is pressed down by the lower pressing plate 62, it will not affect the apposition effect. However, if the lower pressing plate 62 presses down the entire upper area 22 of the apposition leaflet 2, it will cause the apposition leaflet 2 to be excessively pressed down and unable to completely apposition with the anterior valve leaflet, which will affect the shape of the apposition leaflet 2. Therefore, we choose to press down the middle area 21 with a large blood flow impact and a large amount of blood. When the autologous valve is in a closed state, the left and right sides of the upper area 22 fit the autologous valve leaflet, which makes the upper area 22 of the apposition leaflet 2 present a shape with a concave middle and bulging on both sides, as shown in FIG. Figure 8 As shown, the bulged sides on both sides are in close contact with the native valve leaflets. Since the blood flow in the two side areas is small and the impact is small, the blood is held by the bulged parts on both sides to prevent the backflow of this part of the blood. In addition, the anti-wrinkle rod 7 can maintain the arched shape of the apposing leaflets 2 while preventing the bulges on both sides of the apposing leaflets 2 from squeezing toward the middle area 21 when the apposing leaflets 2 are in engagement, causing deformation of the apposing leaflets 2 and affecting the treatment effect. This method not only avoids the blood from seeping into the space between the apposing leaflets 2 and the native valve leaflets to cause backflow on both sides, but also maintains the shape of the apposing leaflets 2 so that it can better align with the native anterior valve leaflet.

[0060] In this embodiment, the lower pressing plate 62 is mainly used for areas with large blood flow and strong impact force, and cannot affect the shape of the apposed leaves 2. Therefore, the maximum width of the lower pressing plate 62 is less than or equal to two-thirds of the width of the upper area 22 after expansion.

[0061] The foregoing description of the above-described embodiments of the present application is presented for illustrative purposes. The foregoing description is not intended to be exhaustive, nor is it intended to limit the present application to the precise configurations, constructions, and / or steps disclosed, and it is apparent that many modifications and variations may be made in light of the teachings above. The scope of the present invention and all equivalents are intended to be defined by the appended claims.

Claims

1. An artificial leaflet device for improving heart valve coaptation, comprising a fixing frame, coapting leaves connected to the fixing frame, fixing pins, and limiting wires, wherein the fixing frame is covered with a fabric layer, the fixing frame is anchored to an autologous valve ring or atrial tissue through the fixing pins, one end of the limiting wire is connected to the coapting leaves, and the other end of the limiting wire is fixed to chordae tendineae or papillary muscles, characterized in that: A fitting device is provided on the fixed frame, and the fitting device includes a threaded needle and a lower pressing plate connected to the threaded needle, wherein the lower pressing plate is a hard part, wherein the lower pressing plate is located in the middle area of ​​the apposing leaflets. During implantation, the threaded needle passes through the fabric layer on the fixed frame and penetrates into the atrial tissue, and the lower pressing plate is closely attached to the middle area of ​​the apposing leaflets and makes the middle area of ​​the apposing leaflets close to the atrial tissue or the autologous valve leaflets.

2. An artificial leaflet device for improving heart valve coaptation according to claim 1, characterized in that: The longer the stroke of the threaded needle piercing the atrial tissue is, the shorter the distance between the lower pressing plate and the atrial wall or the native valve leaflet is.

3. An artificial leaflet device for improving heart valve coaptation according to claim 1, characterized in that: The lower pressing plate is connected to the fabric layer of the fixed frame by means of a stitch on one side.

4. An artificial leaflet device for improving heart valve coaptation according to claim 3, characterized in that: The lower pressing plate is provided with a connecting hole, and the tail of the threaded needle is provided with a groove matched with the connecting hole, so that the threaded needle is sleeved on the lower pressing plate.

5. The artificial leaflet device for improving heart valve coaptation according to claim 1, characterized in that: The opposing blades are provided with an anti-wrinkle rod, wherein the anti-wrinkle rod divides the opposing blades into an upper area and a lower area, and the lower pressing plate is located in the upper area.

6. An artificial leaflet device for improving heart valve coaptation according to claim 5, characterized in that: The axial length of the upper region accounts for one third of the axial length of the opposing blades.

7. An artificial leaflet device for improving heart valve coaptation according to claim 5, characterized in that: The anti-wrinkle rod is in an arched shape, so that the upper area is concave in the middle and bulged on both sides.

8. An artificial leaflet device for improving heart valve coaptation according to claim 7, characterized in that: When the native valve is in a closed state, the left and right sides of the upper region fit the native valve leaflets.

9. An artificial leaflet device for improving heart valve coaptation according to claim 5, characterized in that: The maximum width of the lower pressing sheet is less than or equal to two-thirds of the width of the upper region after unfolding.

10. The artificial leaflet device for improving heart valve coaptation according to claim 1, characterized in that: The lower pressing plate includes a woven mesh in a rectangular structure and a biological material coated on the woven mesh, wherein the woven mesh is woven with memory metal wire.

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