An implantable device for treating valvular regurgitation

Abstract

The present application relates to the field of medical devices, and in particular to an implantable device for treating valvular regurgitation, comprising a fixing bracket, a closing aid, a fixing member and an adjustment mechanism, wherein the closing aid is anchored to atrial tissue through the fixing member, one end of the adjustment mechanism is connected to the closing aid, and one end of the adjustment mechanism is fixed to ventricular tissue or apical tissue, the closing aid comprises an upper region and a lower region, the fixing bracket is connected to the upper region, and one end of the adjustment mechanism is connected to the lower region, wherein both sides of the upper region are concave toward the center of the upper region, and a shape retaining member is provided at the junction of the upper region and the lower region; the present invention can effectively avoid interference between the closing aid and the native anterior valve leaflet, resulting in wrinkles, thrombus accumulation, calcification and other adverse conditions of the closing aid, and has great clinical significance.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to an implantable device for treating valvular regurgitation. 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 valve base 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 two types: 1. Rheumatic mitral regurgitation, primarily caused by mitral valve insufficiency, results in reverse blood flow, resulting in mixing of different blood types and impaired heart pumping and oxygen delivery. 2. Non-rheumatic mitral regurgitation, generally refers to varying degrees of mitral regurgitation caused by abnormalities of the mitral valve itself and surrounding anatomical structures, in addition to rheumatic valvular disease. Non-rheumatic mitral regurgitation has many causes, the most common of which include mitral valve prolapse, papillary muscle insufficiency or chordae tendineae rupture, left atrial myxoma, annular calcification, congenital valve malformations, and infective endocarditis. Mitral regurgitation can also be categorized as 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 commonly 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 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 the mitral valve is diseased, we usually replace the diseased posterior leaflet so that the implanted patch is aligned with the anterior leaflet. For example, patent CN202210378044.2 discloses a patch for repairing mitral regurgitation, including a positioning part, a supporting part and a moving part. After the patch is implanted, the positioning part is fixed on the native valve ring or atrial tissue, the supporting part is arranged in a grid-like structure, the surface of the supporting part is covered with a film, and the supporting part has a predetermined shape; the moving part is made of a flexible biomaterial or a polymer material, and the moving part can move with the movement of the native leaflet; when the native valve is in a closed state, the supporting part and the moving part are both in contact with the adjacent native leaflet; when the native valve is in an open state, the position of the supporting part remains unchanged, and the moving part moves with the movement of the native leaflet, so that blood can flow from the left atrium to the left ventricle; and this patent solution Although the inner and outer skeletons can provide effective morphological support for the upper part of the patch, so that it can better achieve alignment with the anterior leaflet, when the valve is closed, the outer skeleton will collide with the anterior leaflet, causing damage to the anterior leaflet. In addition, since the shape of the anterior leaflet is not a one-segment arc when the valve is closed (when viewed from above the autologous valve ring), but a three-segment arc (specifically, the three areas corresponding to A1, A2, and A3), when the patch is closed, it will contact and squeeze the anterior leaflet in the A1 and A3 areas, causing the two sides of the patch to be squeezed, resulting in wrinkles in the patch, which is not conducive to the alignment between the leaflets, and is prone to blood accumulation, resulting in thrombosis, calcification and other problems.

[0006] In summary, existing repair devices have at least the following technical pain points: 1. When the existing closing aid is engaged with the anterior valve leaflet, the two sides of the closing aid will be squeezed by the anterior valve leaflet (areas A1 and A3), resulting in wrinkles, blood accumulation, thrombosis, calcification and other problems; 2. Although the shape retaining member provided on the upper half of the closing aid can maintain the arched shape (helping to prevent blood reflux), the shape retaining member is prone to collision with the anterior valve leaflet during engagement, causing damage to the anterior valve leaflet and thus affecting the repair effect. Summary of the Invention

[0007] This application is proposed in view of the above and other more concepts.

[0008] One of the purposes of this application is to overcome the shortcomings of the existing technology. For example, in the existing technology, how can the closing aid in closing be effectively aligned with the anterior valve leaflet while reducing or avoiding unnecessary contact and collision with the anterior valve leaflet? An implant device for treating valvular regurgitation is provided.

[0009] The technical solution adopted to solve the technical problem of the present invention is to provide an implantable device for treating valvular regurgitation, including a fixing bracket, a closing aid, a fixing member and an adjustment mechanism, wherein the closing aid is anchored to atrial tissue through the fixing member, one end of the adjustment mechanism is connected to the closing aid, and one end of the adjustment mechanism is fixed to ventricular tissue or apical tissue, the closing aid includes an upper area and a lower area, the fixing bracket is connected to the upper area, and one end of the adjustment mechanism is connected to the lower area, wherein both sides of the upper area are concave toward the center of the upper area, and a shape retaining member is provided at the junction of the upper area and the lower area.

[0010] As a further improvement of the present invention, the shape retaining member is arranged at the lower edge of the upper area, and the shape retaining member is in an arched shape.

[0011] As a further improvement of the present invention, when the native valve is closed, the native annulus, viewed from the atrium looking down upon the native valve annulus, is divided into three regions, A1, A2, and A3, specifically a three-segment arcuate structure. The native posterior leaflet corresponds to three regions, P1, P2, and P3. Clinical data show that the probability of lesions in the P2 region is much greater than in the P1 and P3 regions. Therefore, repair is primarily performed on the P2 region, while simultaneously avoiding interference with the apposition of the A1, A3 regions with the P1 and P3 regions (because when the closing aid covers the P1 and P3 regions and appositions with the A1 and A3 regions, the A1 and A3 regions would squeeze the sides of the closing aid, causing wrinkles on both sides of the closing aid and affecting the repair effect). Therefore, the sides of the upper region are concave toward the center of the upper region, so that neither side of the upper region contacts the adjacent native leaflet, thereby preventing the native anterior leaflet from squeezing the sides of the upper region.

[0012] As a further improvement of the present invention, the shape retaining member has a certain rigidity, and the upper area and the lower area are divided by the shape retaining member, which enables the shape retaining member to provide effective shape support to the lower edge area of ​​the upper area and the upper edge area of ​​the lower area. At the same time, when the autologous valve is closed, the shape retaining member does not contact the autologous anterior leaflet, thereby playing a shape support effect without causing damage to the autologous anterior leaflet.

[0013] As a further improvement of the present invention, the two sides of the upper region are concave arc structures. When the valve is closed, the upper region bulges outward so that the upper region replaces the P2 area of ​​the native posterior leaflet and mates with its native anterior leaflet. The two sides of the upper region make room for the native leaflets in the P1 and P3 areas, so that they mate with the A1 and A3 areas of the native anterior leaflet. This can prevent the native anterior leaflet from squeezing the two sides of the closing aid and the occurrence of wrinkles, while effectively repairing the regurgitation area.

[0014] As a further improvement of the present invention, the height of the upper area is 4-10 mm, and a shape retaining member is provided at the lower edge of the upper area. Furthermore, the height value range of the upper area is 4-10 mm, which enables the shape retaining member to provide effective shape support while effectively avoiding the collision between the shape retaining member and the autologous anterior leaflet when the closing aid is closed, thereby effectively protecting the native leaflet and ensuring a long-term repair effect.

[0015] As a further improvement of the present invention, a curling structure is provided on the left and right sides of the upper area, and the curling structure makes the left and right sides of the upper area curl backward. When the valve is closed, the blood will hit the middle position of the upper area and will be diverted to both sides. In order to avoid being squeezed by the native anterior valve leaflet, the two sides of the upper area are "cut off" a part. Therefore, the reflux pressure on both sides of the upper area will be relatively large, and the curling structure on both sides of the upper area can just allow the diverted blood to flow to the rear of the closing aid, effectively avoiding the blood from flowing back from both sides of the upper area, avoiding squeezing and interference of the native valve leaflet, and providing effective guidance for the shunting of blood to avoid reflux.

[0016] As a further improvement of the present invention, the width of the upper region is smaller than the width of the native valve ring P2 region.

[0017] As a further improvement of the present invention, the lower area is generally designed as a rectangular structure, and the left and right sides of the lower edge of the lower area are provided with chamfers. The chamfer design is to prevent the closing aid from being hooked with the tendon tissue of the autologous posterior valve leaflet when opening and closing. In addition, the width of the lower edge of the lower area does not exceed 35 mm. This is to prevent the lower area from being too wide when the ventricle contracts, which may cause the lower area to collide with the myocardium in the ventricle and cause damage to the myocardium.

[0018] As a further improvement of the present invention, the lower edge of the lower area is provided with a first adjustment unit, a second adjustment unit, a third adjustment unit, a first connecting section and a second connecting section, the second adjustment unit and the third adjustment unit are respectively arranged on the left and right sides of the first adjustment unit, wherein the first adjustment unit is connected to the second adjustment unit and the third adjustment unit through the first connecting section and the second connecting section respectively.

[0019] As a further improvement of the present invention, the stiffness of the first adjustment unit, the second adjustment unit and the third adjustment unit is greater than the stiffness of the first connecting section and the second connecting section.

[0020] As a further improvement of the present invention, the first connecting segment and the second connecting segment are flexible segments, and when the closing aid is impacted by blood flow, the first connecting segment and the second connecting segment will deform in accordance with the impact of the blood flow.

[0021] As a further improvement of the present invention, the first connecting segment and the second connecting segment are elastic, so that the first connecting segment and the second connecting segment can return to a preset shape after being deformed by blood flow impact.

[0022] Compared with the prior art, the advantages of the technical solution of this application include at least the following:

[0023] In the prior art, when the valve of the closing aid is closed, the autologous anterior valve leaflet will squeeze the two sides of the closing aid, causing wrinkles in the closing aid, which will in turn cause blood to accumulate in the wrinkles, resulting in adverse conditions such as thrombosis and calcification. At the same time, although the shape retaining member on the closing aid can maintain the shape of the valve leaflet, it is easy to collide with the anterior valve leaflet and damage the anterior valve leaflet. According to one concept of the present application, the two sides of the upper area are concave toward the center of the upper area, which effectively avoids the autologous anterior valve leaflet squeezing the two sides of the closing aid when the closing aid is closed. At the same time, the shape retaining member can provide effective morphological support for the closing aid while avoiding damage to the autologous anterior valve leaflet, which is beneficial to the long-term repair effect of the device and has good clinical significance.

[0024] According to one concept of the present application, a curling structure is provided on the left and right sides of the upper area. The advantage of this design is that when the valve is closed, the blood will be diverted to both sides after hitting the middle position of the upper area, and in order to avoid being squeezed by the native anterior valve leaflet, the two sides of the upper area are "cut off" in part. Therefore, the reflux pressure on both sides of the upper area will be relatively large, and the curling structure on both sides of the upper area can just allow the diverted blood to flow to the back of the closing aid, effectively avoiding the blood from flowing back from both sides of the upper area, avoiding squeezing and interference of the native valve leaflet, and providing effective guidance for the shunting of blood to avoid reflux.

[0025] According to one concept of the present application, the lower area is provided with chamfers on the left and right sides of the lower edge. The chamfer design is to prevent the closing aid from being hooked with the chordae tendineae of the autologous posterior valve leaflet when opening and closing. In addition, the width of the lower edge of the lower area does not exceed 35 mm. This is to prevent the lower area from being too wide when the ventricle contracts, which may cause the lower area to collide with the myocardium in the ventricle and cause damage to the myocardium.

[0026] According to one concept of the present application, a first adjustment unit, a second adjustment unit, a third adjustment unit, a first connecting section, and a second connecting section are provided at the lower edge of the lower area, so that when the closing aid is subjected to blood flow impact, each adjustment unit can effectively adjust its corresponding area relatively independently. At the same time, the connecting section can not only ensure the relative independence of each adjustment unit, but also play an effective supporting role for the distal part of the closing aid, further ensuring that the closing aid can buffer and adapt to its deformation after being subjected to different degrees of blood flow impact, avoiding stress concentration in certain local areas of the closing aid and causing damage to the closing aid. Moreover, after the blood flow impact fades, the closing aid can quickly return to its original state, effectively avoiding wrinkles in the closing aid, which may lead to adverse conditions such as thrombus accumulation and calcification in the long run, and has great clinical significance.

[0027] 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 can be anticipated and understood by those skilled in the art after reading this application. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The above features and advantages of these embodiments and other features and advantages and the manner in which they are achieved will become more apparent, and the embodiments of the present application may be better understood, by referring to the following description taken in conjunction with the accompanying drawings, in which:

[0029] Figure 1 Schematic diagram of the overall structure of the implant device of the present invention.

[0030] Figure 2 It is a side view of the implant device of the present invention.

[0031] Figure 3 This is a schematic diagram of the overall structure of the implantable device of the present invention positioned in the heart.

[0032] Figure 4 Schematic diagram of the curled structure diverting blood when blood flows into the upper area.

[0033] Figure 5 Schematic diagram of the mitral valve area.

[0034] Figure 6 This is a schematic diagram of the closure aid and the anterior leaflet after the implant device is implanted.

[0035] Figure 7 This is a schematic diagram showing that when the closing aid is impacted by blood flow, the second connecting section deforms in accordance with the impact of blood flow.

[0036] Figure 8 for Figure 7 rear view.

[0037] The features indicated by the numbers in the accompanying drawings are as follows:

[0038] 1-Fixed bracket, 2-Closing aid, 21-Upper area, 22-Lower area, 23-Shape retaining member, 24-Curling structure, 25-Chamfer, 3-Fixed member, 4-Adjustment mechanism, 5-First adjustment unit, 6-Second adjustment unit, 7-Third adjustment unit, 8-First connecting section, 9-Second connecting section Implementation Method

[0039] In the following description of the drawings and specific embodiments, details of one or more embodiments of the present application will be described. Other features, purposes and advantages of the present application will be clear from these descriptions, drawings and claims.

[0040] 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 can be implemented or executed in various ways. Each example is provided in an explanation of the disclosed embodiments, not in a limiting manner. 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 of the disclosure of the present application. For example, a feature illustrated or described as part of one embodiment may be used in conjunction with another embodiment to still produce another embodiment. Therefore, the present application discloses such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0041] 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," "comprising," or "having" and variations thereof herein is intended to encompass the items listed thereafter and their equivalents as well as additional items.

[0042] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the application.

[0043] In this application, the term "the other end" or "proximal end" or "proximal side" refers to the end or side closer to the centrifugal tip, and "one end" or "distal end" or "distal side" refers to the end or side farther from the centrifugal tip.

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

[0045] like Figure 1 and Figure 2As shown, an implant device for treating valvular regurgitation according to an embodiment of the present application is illustrated, which is used to repair the mitral valve. Common methods for repairing the mitral valve include clipping leaflets, shrinking rings, etc. The repair route adopted in this solution is to replace the posterior leaflet of the native valve and increase the area of ​​​​coaptation with the native anterior leaflet to reduce regurgitation. According to clinical data, the area where the native posterior leaflet mainly prolapses is in the P2 area, so the target area for repair is in the P2 area. It is necessary to minimize the interference of the P1 and P3 areas and avoid the interference of the native anterior leaflet A1 and A3 areas on both sides of the closing aid 2. Specifically, the implant device for treating valvular regurgitation includes a fixed bracket 1, a closing aid 2, a fixing member 3 and an adjustment mechanism 4. The closing aid 2 is anchored on the atrial tissue through the fixing member 3. One end of the adjustment mechanism 4 is connected to the closing aid 2, and one end of the adjustment mechanism 4 is fixed on the papillary muscle tissue. Figure 3 As shown, the closing aid 2 includes an upper region 21 and a lower region 22. The fixing bracket 1 is connected to the upper region 21, and one end of the adjustment mechanism 4 is connected to the lower region 22. The two sides of the upper region 21 are concave toward the center of the upper region 21. A shape retaining member 23 is provided at the junction of the upper region 21 and the lower region 22. The shape retaining member 23 is provided at the lower edge of the upper region 21 and has an arched shape.

[0046] In this embodiment, when the native valve is closed, from the perspective of looking down at the native valve annulus from the atrium, the native anterior leaflet is divided into three areas A1, A2, and A3, specifically a three-segment arc structure, such as Figure 5 As shown in FIG, the autologous posterior leaflet corresponds to the three regions P1, P2, and P3. According to clinical data, the probability of lesions in the P2 region is much greater than that in the P1 and P3 regions. Therefore, we mainly repair the P2 region, and at the same time, we cannot interfere with the alignment of the A1, A3 and P1 and P3 regions (because when the closing aid 2 covers the P1 and P3 regions and is aligned with the A1 and A3 regions, the A1 and A3 regions will squeeze the two sides of the closing aid 2, causing wrinkles on both sides of the closing aid 2, affecting the repair effect). Therefore, the two sides of the upper region 21 are concave toward the center of the upper region 21, so that the two sides of the upper region 21 do not contact the adjacent autologous leaflet, avoiding the compression of the two sides of the upper region 21 by the autologous anterior leaflet. Figure 6 shown.

[0047] In this embodiment, the shape retaining member 23 has a certain rigidity, and the upper area 21 and the lower area 22 are divided by the shape retaining member 23, so that the shape retaining member 23 can provide effective shape support to the lower edge area of ​​the upper area 21 and the upper edge area of ​​the lower area 22. At the same time, when the autologous valve is closed, the shape retaining member 23 does not contact the autologous anterior leaflet, thereby playing a shape support effect without causing damage to the autologous anterior leaflet.

[0048] In this embodiment, the two sides of the upper region 21 are concave arc-shaped structures. When the valve is closed, the upper region 21 bulges outward so that the upper region 21 replaces the P2 area of ​​the native posterior leaflet and mates with its native anterior leaflet. The two sides of the upper region 21 make room for the native leaflets in the P1 and P3 areas, so that they mate with the A1 and A3 areas of the native anterior leaflet. This can prevent the native anterior leaflet from squeezing the two sides of the closing aid 2, avoid the occurrence of wrinkles, and effectively repair the regurgitation area.

[0049] In this embodiment, the height of the upper region 21 is 4-10 mm, and a shape retaining member 23 is provided at the lower edge of the upper region 21. Furthermore, the height value range of the upper region 21 is 4-10 mm, which enables the shape retaining member 23 to provide effective shape support while effectively preventing the shape retaining member 23 from colliding with the native anterior leaflet when the closing aid 2 is closed, thereby effectively protecting the native leaflet and ensuring a long-term repair effect.

[0050] In this embodiment, if Figure 1 and Figure 2 As shown, the left and right sides of the upper region 21 are provided with curling structures 24, and the curling structures 24 make the left and right sides of the upper region 21 curl backward. When the valve is closed, the blood will flow to both sides after impacting the middle position of the upper region 21, as shown in FIG. Figure 4 As shown, in order to avoid being squeezed by the native anterior leaflet, the two sides of the upper region 21 are partially "cut off". Therefore, the reflux pressure on both sides of the upper region 21 will be relatively large. The curled structures 24 on both sides of the upper region 21 can just allow the shunted blood to flow to the rear of the closing aid 2, effectively preventing the blood from reflux from both sides of the upper region 21, avoiding squeezing and interference by the native leaflet, and providing effective guidance for the shunted blood to prevent reflux.

[0051] In this embodiment, the width of the upper region 21 is smaller than the width of the native valve ring P2 region.

[0052] In this embodiment, the lower region 22 is generally designed as a rectangular structure, and the lower region 22 is provided with chamfers 25 on the left and right sides of the lower edge. The chamfers 25 are designed to prevent the closing aid 2 from being hooked with the chordae tendineae of the native posterior leaflet during opening and closing. In addition, the width of the lower edge of the lower region 22 does not exceed 35 mm. This is to prevent the lower region 22 from being too wide during ventricular contraction, which may cause the lower region 22 to collide with the myocardium in the ventricle and cause damage to the myocardium.

[0053] In this embodiment, the lower edge of the lower area 22 is provided with a first adjustment unit 5, a second adjustment unit 6, a third adjustment unit 7, a first connecting segment 8 and a second connecting segment 9, the second adjustment unit 6 and the third adjustment unit 7 are respectively arranged on the left and right sides of the first adjustment unit 5, wherein the first adjustment unit 5 is connected to the second adjustment unit 6 and the third adjustment unit 7 through the first connecting segment 8 and the second connecting segment 9, respectively. Figure 1 shown.

[0054] In this embodiment, the stiffness of the first adjustment unit 5 , the second adjustment unit 6 , and the third adjustment unit 7 is greater than the stiffness of the first connecting section 8 and the second connecting section 9 .

[0055] In this embodiment, the first connecting section 8 and the second connecting section 9 are flexible sections, and when the closing aid 2 is impacted by blood flow, the first connecting section 8 and the second connecting section 9 will deform in accordance with the impact of the blood flow. Figure 7 and Figure 8 shown.

[0056] In this embodiment, the first connecting section 8 and the second connecting section 9 are elastic, so that the first connecting section 8 and the second connecting section 9 can return to a preset shape after being deformed by blood flow impact. Figure 1 shown.

[0057] An exemplary operation process of repairing a mitral valve using an implantable device for treating valvular regurgitation according to the first embodiment is as follows:

[0058] 1. The delivery system is delivered via a transapical approach through the patient's left ventricle to the left atrium;

[0059] 2. Positioning the fixing stent 1 at the native valve annulus, and further releasing the fixing member 3 so that the fixing member 3 passes through the fixing stent 1 and penetrates the native valve annulus tissue to achieve anchoring;

[0060] 3. Gradually release the closing aid 2 from the distal end to the proximal end, and fix the proximal end of the adjustment mechanism 4 to the papillary muscle. At this point, the anti-reflux prosthesis replaces the function of a single native valve and achieves coaptation with adjacent native valve leaflets.

[0061] 4. Withdraw the delivery device of the implantable device for treating valvular regurgitation, completing the operation.

[0062] The foregoing description of the embodiments of the present application has been presented for illustrative purposes. The foregoing description is not intended to be exhaustive or to limit the present application to the precise configurations, constructions, and / or steps disclosed. Obviously, many modifications and variations are possible in light of the above teachings. It is intended that the scope of the present invention and all equivalents thereof be defined by the appended claims.

Claims

1. An implantable device for treating valvular regurgitation, comprising a fixing bracket, a closing aid, a fixing member, and an adjustment mechanism, wherein the closing aid is anchored to atrial tissue via the fixing member, one end of the adjustment mechanism is connected to the closing aid, and one end of the adjustment mechanism is fixed to ventricular tissue or apical tissue, characterized in that: The closing aid includes an upper region and a lower region, the fixing bracket is connected to the upper region, and one end of the adjustment mechanism is connected to the lower region, wherein both sides of the upper region are concave toward the center of the upper region, and a shape retaining member is provided at the junction of the upper region and the lower region, the shape retaining member is provided at the lower edge of the upper region, and the shape retaining member is arched. When the native valve is closed, the lower edge of the upper region and both sides of the upper region do not contact the adjacent native valve leaflets; and the left and right sides of the upper region are provided with a curling structure, and the curling structure causes the left and right sides of the upper region to curl backward.

2. The implantable device for treating valvular regurgitation according to claim 1, characterized in that: Both sides of the upper area are in an inwardly concave arc structure.

3. The implantable device for treating valvular regurgitation according to claim 1, characterized in that: The height of the upper region is 4-10 mm.

4. The implantable device for treating valvular regurgitation according to claim 1, characterized in that: The width of the upper region is smaller than the width of the native valve ring P2 region.

5. The implantable device for treating valvular regurgitation according to claim 1, characterized in that: The lower region has chamfers on both sides of the lower edge, and the width of the lower edge of the lower region does not exceed 35 mm.

6. The implantable device for treating valvular regurgitation according to claim 5, characterized in that: The lower edge of the lower area is provided with a first adjustment unit, a second adjustment unit, a third adjustment unit, a first connecting section and a second connecting section, the second adjustment unit and the third adjustment unit are respectively arranged on the left and right sides of the first adjustment unit, wherein the first adjustment unit is connected to the second adjustment unit and the third adjustment unit through the first connecting section and the second connecting section respectively.

7. The implantable device for treating valvular regurgitation according to claim 6, characterized in that: The stiffness of the first adjustment unit, the second adjustment unit, and the third adjustment unit is greater than the stiffness of the first connecting section and the second connecting section.

8. The implantable device for treating valvular regurgitation according to claim 6, characterized in that: The first connecting section and the second connecting section are flexible sections, and when the closing aid is impacted by blood flow, the first connecting section and the second connecting section will deform in accordance with the impact of the blood flow.

9. The implantable device for treating valvular regurgitation according to claim 6, characterized in that: The first connecting segment and the second connecting segment are elastic, so that the first connecting segment and the second connecting segment can return to a preset shape after being deformed by blood flow impact.

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