A heart valve repair system

Abstract

This application relates to the field of medical devices, and particularly to a cardiac valve forming system, which includes a contraction framework, a covering layer covering the contraction framework, a wire for controlling the contraction of the contraction framework, and a fixing element for anchoring the contraction framework to cardiac tissue. The wire includes a control part and a connection part. The connection part is connected to the contraction framework, and the control part is arranged between two ends of the contraction framework. Moreover, operating the control part causes the connection part to pull the contraction framework to contract. Wherein, after the contraction framework is implanted, one end of each of the first contraction member and the second contraction member adjacent to each other is respectively arranged at two ends of the support framework. The solution of the present invention can not only significantly increase the coaptation area between adjacent valve leaflets, but also avoid excessive traction of the anterior valve leaflet, avoid affecting the aortic valve, and reduce postoperative complications.

Description

Technical Field

[0001] This application relates to the field of medical devices, and particularly to a cardiac valve repair system. Background Art

[0002] With the advent of population aging, the incidence of heart valve diseases has increased significantly. In particular, mitral regurgitation (MR) has an incidence more than five times that of patients with aortic valve stenosis. It is estimated that there are more than 10 million severe MR patients in China. MR is caused by changes in the mitral leaflets and their structures, resulting in poor anastomosis of the anterior and posterior mitral leaflets, and blood flowing back from the left ventricle to the left atrium, thus causing some symptoms. According to the pathogenesis, MR can be divided into primary (organic) and secondary (functional), each accounting for about 50%. Mild MR patients may not show clinical symptoms for a long time and have a good prognosis. Severe MR patients may be accompanied by symptoms such as palpitations, chest tightness, and shortness of breath. Acute severe MR patients have very poor tolerance and are prone to death. Clinical studies have shown that drug treatment can only improve the symptoms of patients, but cannot extend their survival time or the timing of surgery. Surgical valve repair or replacement is recognized as the standard method for treating MR and has been proven to relieve patients' symptoms and extend their survival time. However, surgical treatment has the disadvantages of large trauma, slow postoperative recovery, obvious postoperative pain, and high risks. At the same time, 50% of MR patients are not suitable for surgery due to high-risk factors such as low cardiac function, advanced age, and a history of thoracotomy and cannot receive effective treatment. In the past decade or so, transcatheter mitral valve intervention technology has developed rapidly. In particular, the listing of MitraClip has brought hope to many patients. The latest research shows that MitraClip has a better treatment effect on functional regurgitation than drug treatment. Facing the huge market, major enterprises and capital have flocked to the field of MR treatment.

[0003] Patent CN2022101932385 discloses an implantable device for repairing a valve, including a shaping device, a control element for controlling the contraction of the shaping device, and a fixing element for anchoring the shaping device to cardiac tissue. The shaping device includes at least two shrinking ring members, and the at least two shrinking ring members are adjacently anchored to the autologous annulus or atrial tissue through the fixing element. The control element is manipulated to cause the shrinking ring members to contract, and the adjacent ends of the shrinking ring members all move closer to the center of the autologous valve. However, the applicant found in the experiment that the following technical problems exist: 1. Although the two ends move significantly towards the valve center after shrinking the ring, since the anterior leaflet area is close to the aortic valve, if the movement amplitude in the anterior leaflet area is too large, it will affect the blood flow supply of the aorta and cause complications; 2. The control wire is arranged at the end of the shrinking ring member. When contracting, the force at the end is concentrated, which poses a great test to the strength of the control wire.

[0004] In summary, although the above technologies have achieved some clinical results, they all have deficiencies. There is an urgent need for a new cardiac valve plasty system to solve the above problems. Summary of the Invention

[0005] In view of the above and other concepts, this application is proposed. The main purpose of this application is to overcome some problems and deficiencies of the prior art.

[0006] In the application of atrioventricular valve surgery, this application aims to provide a cardiac valve plasty system for patients with diseased cardiac valves who require interventional treatment, thereby solving problems such as a relatively large movement distance in the anterior leaflet region and affecting the blood flow supply to the aortic valve in the prior art.

[0007] The technical solution adopted to solve the technical problems of the present invention is: a cardiac valve plasty system, including a contraction framework, a covering layer covering the contraction framework, a wire for controlling the contraction of the contraction framework, and a fixing element for anchoring the contraction framework to the cardiac tissue. The wire includes a control part and a connection part. The connection part is connected to the contraction framework, and the control part is arranged between the two ends of the contraction framework. Moreover, operating the control part causes the connection part to pull the contraction framework to contract. Among them, after the contraction framework is implanted, one end of the first contraction part and the second contraction part adjacent to each other are respectively arranged at both ends of the support framework.

[0008] As a further improvement of the present invention, the first contraction part and the second contraction part are respectively provided with wires for controlling contraction, and the wires are in a closed-loop structure; after the first contraction part and the second contraction part are anchored on the annulus, by twisting the control part, the connection part drives the first contraction part and the second contraction part to contract.

[0009] As a further improvement of the present invention, the connection part of the wire is fixed to the first contraction part or the second contraction part along the edge of the first contraction part or the second contraction part; fixing along the edge for one week can make the force application points of the wire more and more uniform when pulling the first contraction part or the second contraction part.

[0010] As a further improvement of the present invention, the length of the control part from the adjacent ends of the first contraction part and the second contraction part accounts for two-thirds of the transverse length of the first contraction part or the second contraction part.

[0011] As a further improvement of the present invention, both the first contraction member and the second contraction member include a front contraction portion and a rear contraction portion, and the control portion is disposed at the junction of the front contraction portion and the rear contraction portion. By operating the control portion, after the first contraction member and the second contraction member contract, the contraction stroke of the rear contraction portion is greater than that of the front contraction portion; this causes the P2 region of the posterior leaflet to move significantly towards the center of the valve, while the anterior leaflet region moves slightly towards the center of the valve, which can effectively increase the coaptation area between the leaflets and avoid problems with aortic blood flow supply caused by excessive movement of the anterior leaflet region.

[0012] As a further improvement of the present invention, the stiffness of the front contraction portion is greater than that of the rear contraction portion, so that after the first contraction member or the second contraction member contracts, the swing amplitude of the rear contraction portion towards the center of the valve is greater than that of the front contraction portion towards the center of the valve.

[0013] As a further improvement of the present invention, it further includes a support framework, and the support framework is an open-loop structure. Among them, the support framework is respectively connected to the first contraction member and the second contraction member, and the adjacent ends of the first contraction member and the second contraction member are respectively disposed at both ends of the support framework.

[0014] As a further improvement of the present invention, the support framework is composed of several support units in the shape of "Ω", and the stiffness of the support units corresponding to each region of the autologous annulus is different. Among them, the stiffness of the support units located in the set annulus reduction region is less than that of the support units at the leaflet junction.

[0015] As a further improvement of the present invention, at least one fixing element is anchored in the front contraction portion region, and at least two fixing elements are anchored in the rear contraction portion region.

[0016] As a further improvement of the present invention, the covering layer is a fabric, and the covering layer is a closed-loop structure adapted to the shape of the annulus; this enables the entire ring to be directly buckled onto the autologous annulus during implantation without relying too much on imaging for positioning.

[0017] As a further improvement of the present invention, when used for mitral valve treatment, the set annulus reduction region is located in the P2 region of the autologous annulus, and the adjacent ends of the first contraction member and the second contraction member are disposed in the P2 region of the autologous annulus. When it contracts, the P2 region will move significantly towards the center of the valve, thereby driving the posterior leaflet to abut against the anterior leaflet and increasing the coaptation area between the leaflets, thus effectively treating regurgitation.

[0018] Compared with the prior art, the advantages and beneficial technical effects of the present application at least include the following:

[0019] 1. In the prior art, when the plasty device contracts, although it can significantly move the P2 region of the autologous annulus closer to the valve center, due to the interaction of forces, it also causes the anterior annulus region to move excessively towards the valve center. Although it can increase the coaptation area of the autologous leaflets, the excessive traction of the anterior leaflet will inevitably affect the aortic valve and cause complications. Therefore, in an embodiment of the present application, the length of the control part from the adjacent ends of the first contraction member and the second contraction member accounts for two-thirds of the transverse length of the first contraction member or the second contraction member. This makes the local contraction amplitude of the first contraction member or the second contraction member different during contraction, such that the amplitude of the P2 region of the annulus moving towards the valve center is significantly greater than the amplitude of the anterior annulus region moving towards the valve center. This can not only effectively increase the coaptation area between the leaflets, reduce valve regurgitation, but also avoid excessive movement of the anterior annulus region, which affects the aortic valve and effectively reduces postoperative complications, having good clinical significance.

[0020] 2. Different from the prior art, in an embodiment of the present application, a support framework is provided. The support framework is an open-loop structure, and one end of each of the first contraction member and the second contraction member adjacent to each other is respectively arranged at both ends of the support framework. Also, since one end of the first contraction member and the second contraction member adjacent to each other is arranged in the set annulus reduction region, when it contracts and forms, the set annulus reduction region part (i.e., the P2 region) will significantly move closer to the valve center. And for the anterior annulus region, the force provided by the support framework can offset part of the force of the annulus reduction member during contraction, such that the distance of the anterior annulus region moving towards the valve center is not large, thus effectively avoiding the impact on the aortic valve. At the same time, the atrioventricular valve annuloplasty device is an integral ring structure, making it unnecessary to rely too much on imaging for positioning during implantation. Moreover, the integral ring structure is beneficial for the anchoring of the stent during subsequent replacement treatment, having good clinical significance.

[0021] 3. Different from the prior art, in an embodiment of the present application, the stent framework is composed of several support units, and the stiffness of the support units in different regions is not the same. For example, the stiffness of the support units located in the set annulus reduction region is less than the stiffness of the support units at the leaflet junction. This makes the annulus reduction member non-uniformly contract after contraction, and the contraction distance of the set annulus reduction region (i.e., the P2 region) is greater than the contraction distance of the anterior annulus region, avoiding the influence on the blood flow supply of the aortic valve due to excessive movement of the anterior annulus.

[0022] The embodiments of the present application can achieve other beneficial technical effects not listed one by one. Some of these other technical effects may be partially described below, and can be expected and understood by those skilled in the art after reading the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The above features and advantages of these embodiments, as well as other features and advantages and the ways to achieve them, will become more apparent by referring to the following description in conjunction with the accompanying drawings, and the embodiments of the present application can be better understood. In the drawings:

[0024] Figures 1a to 1d It is a schematic structural diagram of the device for shrinking the mitral annulus of the present invention, where Figure 1d It is a schematic diagram of the form of the wire.

[0025] Figures 2a to 2d It is a schematic diagram of the process of shrinking the mitral annulus by the heart valve plasty system of the present invention. Among them, 2b is a schematic diagram of the device for tightening the annulus on the mitral annulus when the control wire is not tightened, Figure 2d It is a schematic diagram of the device for tightening the annulus on the mitral annulus after the control wire is tightened.

[0026] The names of the parts referred to by each number in the drawings are as follows: 1 - contraction skeleton, 11 - first contraction member, 12 - second contraction member, 13 - front contraction part, 14 - rear contraction part, 2 - covering layer, 3 - wire, 31 - control part, 32 - connection part, 4 - fixing element, 5 - support skeleton, 51 - support unit. Embodiment Embodiment mode

[0027] In the following description of the drawings and specific embodiments, details of one or more embodiments of the present application will be set forth. From these descriptions, drawings, and claims, other features, objects, and advantages of the present application can be clearly understood.

[0028] It should be understood that the embodiments illustrated and described 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 drawings. The illustrated embodiments can be other embodiments and can be implemented or carried out in various ways. Each example is provided by way of explanation rather than limitation of the disclosed embodiments. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of the present application without departing from the scope or essence of the disclosure of the present application. For example, features illustrated or described as part of one embodiment can be used with another embodiment to still produce additional embodiments. Therefore, the disclosure of the present application covers such modifications and variations that fall within the scope of the appended claims and their equivalent elements.

[0029] Similarly, it can be understood that the phrases and terms used herein are for the purpose of description and should not be considered restrictive. The use of "including", "comprising", or "having" and their variants herein is intended to open - endedly include the items listed thereafter and their equivalents, as well as possible additional items.

[0030] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the present application.

[0031] In the present application, the proximal end refers to the end close to the surgical operator, and the distal end refers to the end far from the surgical operator.

[0032] In the prior art, during the process of atrioventricular valve replacement, the autologous valve usually cannot function properly, and this traditional treatment method will cause the entire valve to be in an open reflux state during the replacement process, resulting in a very short operation time and high risk, and may cause various diseases. Embodiment

[0033] As Figures 1a to 1d shown, a cardiac valve plasty system includes a device for contracting the autologous annulus and a delivery device for delivering the device into the heart. The device includes a contraction framework 1, a covering layer 2 covering the contraction framework 1, a wire 3 for controlling the contraction of the contraction framework 1, and a fixing element 4 for anchoring the contraction framework 1 to the heart tissue. Among them, the contraction framework 1 includes a first contraction member 11 and a second contraction member 12. The first contraction member 11 and the second contraction member 12 are respectively provided with a wire 3 for controlling the contraction. And the wire 3 includes a control part 31 and a connection part 32. The connection part 32 refers to the part connected to the first contraction member 11 or the second contraction member 12, and the control part 31 is the part for operating to cause the contraction member to contract. After the contraction framework 1 is delivered to the target position in the heart (at the autologous annulus) through the delivery device, the contraction framework 1 is anchored to the autologous annulus by using the fixing element 4. At this time, one end where the first contraction member 11 and the second contraction member 12 are adjacent is located in the P2 area of the autologous annulus (i.e., the set annulus reduction area), as Figure 2b shown. Subsequently, by turning the control part 31, the connection part 32 drives the first contraction member 11 and the second contraction member 12 to contract, further driving the autologous annulus to achieve constriction, as Figure 2c and 2d shown. And the control part 31 is such that the length from the adjacent end of the first contraction member 11 and the second contraction member 12 accounts for two-thirds of the transverse length of the first contraction member 11 or the second contraction member 12, as Figure 1b shown. Therefore, the distance that the P2 area part of the autologous annulus moves towards the valve center is greater than the distance that the anterior leaflet area moves towards the valve center. This can not only effectively increase the coaptation area between the leaflets, reduce valve regurgitation, but also avoid excessive movement of the anterior leaflet area, affecting the aortic valve, and effectively reduce postoperative complications, having good clinical significance.

[0034] In this embodiment, the wire 3 has a closed-loop structure, as Figure 1dAs shown, the conveyor is provided with a control rod detachably connected to the wire 3. The wire 3 is tightened by rotating the control rod, so that the wire 3 is gradually tightened, further driving the contraction skeleton 1 and the autologous valve ring to achieve tightening and complete the ring shrinkage.

[0035] In this embodiment, the connecting portion 32 of the wire 3 is fixed to the first contraction piece 11 or the second contraction piece 12 along the edge of the first contraction piece 11 or the second contraction piece 12; being fixed along the edge can make the wire 3 have more and more uniform force points when pulling the first contraction piece 11 or the second contraction piece 12.

[0036] In this embodiment, the first contraction member 11 and the second contraction member 12 both include a front contraction portion 13 and a rear contraction portion 14, and the control portion 31 is disposed at the junction of the front contraction portion 13 and the rear contraction portion 14. Figure 1a and 1b As shown, the control unit 31 is operated so that after the first contraction member 11 and the second contraction member 12 are contracted, the contraction stroke of the rear contraction member 14 is greater than the contraction stroke of the front contraction member 13, as shown in FIG. Figure 2c and 2d As shown; this causes the P2 area of ​​the posterior leaflet to move significantly toward the valve center, while the anterior leaflet area moves slightly toward the valve center, which can effectively increase the coaptation area between the leaflets and avoid problems with aortic blood supply caused by excessive movement of the anterior leaflet area.

[0037] In this embodiment, the stiffness of the front contraction part 13 is greater than the stiffness of the rear contraction part 14, so that after the first contraction member 11 or the second contraction member 12 contracts, the swing amplitude of the rear contraction part 14 toward the valve center is greater than the swing amplitude of the front contraction part 13 toward the valve center.

[0038] In this embodiment, the support frame 5 is composed of a plurality of support units 51 in the shape of "Ω", such as Figure 1c As shown, the stiffness of the support unit 51 corresponding to each area of ​​the autologous valve ring is different, wherein the stiffness of the support unit 51 located in the set shrinking ring area is smaller than the stiffness of the support unit 51 at the junction of the leaflets.

[0039] In the present embodiment, at least one fixing element 4 is anchored in the region of the front constriction 13 , and at least two fixing elements 4 are anchored in the region of the rear constriction 14 .

[0040] In this embodiment, the covering layer 2 is fabric, and is a closed-loop structure adapted to the shape of the valve ring; this allows the entire ring to be directly buckled onto the autologous valve ring during implantation without over-reliance on images for positioning.

[0041] An exemplary operation process for repairing the mitral valve of the first embodiment of this cardiac valve plasty system is as follows:

[0042] 1. Operate the delivery system to enter the right atrium from the superior vena cava, and then pass through the interatrial septum to reach the left atrium;

[0043] 2. Release the device for tightening the annulus from the delivery device. At this time, the device is in a ring structure and covers the autologous annulus tissue. Further operate the delivery system to output its fixing element 4 and pass through the fabric layer to anchor the device on the autologous annulus, as Figure 2a and 2b shown;

[0044] 3. Tighten the wire 3 for controlling contraction, so that the first contraction member 11 and the second contraction member 12 contract the annulus, as Figure 2c and 2d shown. Through imaging observation, when the first contraction member 11 and the second contraction member 12 contract to the appropriate position, the delivery device is disassembled from the wire 3 and the delivery system is withdrawn to complete the operation.

[0045] The product of the present invention is not only applicable to repairing mitral valve diseases, but also applicable to tricuspid valve diseases.

[0046] Finally, it should be noted that the above are only the preferred embodiments of the present invention, and do not limit the present invention. Any modifications, equivalent replacements, and improvements within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A heart valve forming system, comprising a contraction framework, a covering layer covering the contraction framework, a wire for controlling the contraction of the contraction framework, a fixing element for anchoring the contraction framework to heart tissue, and a support framework, characterized in that: The wire includes a control part and a connection part. The connection part is connected to the contractile framework. The control part is arranged between two ends of the contractile framework. And by operating the control part, the connection part pulls the contractile framework to contract. The contractile framework includes a first contractile member and a second contractile member. Wherein, after the contractile framework is implanted, one end of the first contractile member and the second contractile member adjacent to each other are respectively arranged at two ends of the support framework. And the length of the control part from the adjacent ends of the first contractile member and the second contractile member accounts for two-thirds of the transverse length of the first contractile member or the second contractile member. The first contractile member and the second contractile member are respectively provided with wires for controlling contraction. And the wires are in a closed-loop structure. The first contractile member and the second contractile member both include a front contractile part and a rear contractile part. And the control part is arranged at the junction of the front contractile part and the rear contractile part. At least one fixing element is anchored in the front contractile part area. And at least two fixing elements are anchored in the rear contractile part area. The stiffness of the front contractile part is greater than that of the rear contractile part. So that after the first contractile member or the second contractile member contracts, the swing amplitude of the rear contractile part towards the valve center is greater than that of the front contractile part towards the valve center.

2. The cardiac valve forming system according to claim 1, characterized in that: By operating the control part, after the first contractile member and the second contractile member contract, the contraction stroke of the rear contractile part is greater than that of the front contractile part.

3. A heart valve forming system according to claim 1, characterized in that: The support framework is in an open-loop structure. Wherein, the support framework is respectively connected to the first contractile member and the second contractile member. And one end of the first contractile member and the second contractile member adjacent to each other are respectively arranged at two ends of the support framework.

4. A heart valve forming system according to claim 1, characterized in that: The support framework is composed of several support units in an "Ω" shape. And the stiffness of the support units corresponding to each area of the autologous valve annulus is different.

5. A heart valve forming system according to claim 1, wherein: The covering layer is a fabric. And the covering layer is in a closed-loop structure adapted to the shape of the valve annulus. And when used for mitral valve treatment, the set annulus contraction area is located in the P2 area of the autologous valve annulus.

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