Implanting instrument for treating valve regurgitation

Abstract

The invention relates to the field of medical instruments, in particular to an implantation instrument for treating valve regurgitation, which comprises a fixing support, a closure assisting part, a fixing part and an adjusting mechanism, the closure assisting part is anchored on atrial tissue through the fixing part, one end of the adjusting mechanism is connected with the closure assisting part, one end of the adjusting mechanism is fixed on ventricular tissue or cardiac apex tissue, and the other end of the adjusting mechanism is connected with the fixing part. The closing assisting part comprises an upper area and a lower area, the fixing support is connected with the upper area, one end of the adjusting mechanism is connected with the lower area, the two sides of the upper area are inwards concave towards the center of the upper area, and a shape maintaining part is arranged at the junction of the upper area and the lower area; according to the invention, unfavorable conditions of wrinkling, thrombus accumulation, calcification and the like of the closure assisting part caused by mutual interference between the closure assisting part and the autologous anterior valve leaflet can be effectively avoided, and good clinical significance is achieved.

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 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 the mitral valve is diseased, we usually replace the diseased posterior leaflet so that the implanted patch can be aligned with the anterior leaflet. For example, patent CN202210378044.2 discloses a patch for repairing mitral regurgitation, including a positioning portion, a supporting portion and a moving portion. After the patch is implanted, the positioning portion is fixed on the native valve ring or atrial tissue, the supporting portion is arranged in a grid-like structure, the surface of the supporting portion is covered with a film, and the supporting portion has a predetermined shape; the moving portion is made of a flexible biomaterial or a polymer material, and the moving portion can move with the movement of the native leaflets; when the native valve is in a closed state, the supporting portion and the moving portion are both in contact with the adjacent native leaflets; when the native valve is in an open state, the position of the supporting portion remains unchanged, and the moving portion moves with the movement of the native leaflets, so that blood can flow from the left atrium to the left ventricle; and this patent scheme Although the exoskeleton can provide effective morphological support for the upper part of the patch, so that it can better align with the anterior leaflet, when the valve is closed, the exoskeleton 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-stage arc when the valve is closed (when viewed from a bird's-eye view of the native valve ring), but a three-stage 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 areas A1 and A3, causing both sides of the patch to be squeezed, resulting in wrinkles in the patch, which is not conducive to the alignment of the leaflets, and is prone to blood accumulation, resulting in thrombosis, calcification and other problems.

[0006] In summary, the repair devices in the prior art have at least the following technical pain points: 1. When the existing closing aid is aligned 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 upper part of the closing aid is provided with a shape retaining member to maintain the arched shape (which is conducive to blocking blood reflux), the shape retaining member is easy to collide with the anterior valve leaflet when aligned, causing damage to the anterior valve leaflet, thereby 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 the present application is to overcome the deficiencies of the prior art, and to provide an implant device for treating valvular regurgitation, for example, to address the problems of how the closing aid in the prior art can effectively engage with the anterior valve leaflet when closing, while reducing or avoiding unnecessary contact and collision with the anterior valve leaflet.

[0009] The technical solution adopted to solve the technical problem of the present invention is to provide an implant device for treating valvular regurgitation, including a fixing bracket, a closing aid, a fixing member and an adjusting mechanism, wherein the closing aid is anchored on the atrial tissue through the fixing member, one end of the adjusting mechanism is connected to the closing aid, and one end of the adjusting mechanism is fixed to the ventricular tissue or the 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 adjusting 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, from the perspective of looking down at the native valve ring from the atrium, the native anterior leaflet is divided into three areas, A1, A2, and A3, which are specifically a three-section arc structure. The native posterior leaflet corresponds to three areas, P1, P2, and P3. According to clinical data, the probability of lesions in the P2 area is much greater than that in the P1 and P3 areas. Therefore, we mainly repair the P2 area, and at the same time, we cannot interfere with the alignment of the A1, A3 and P1, P3 areas (because when the closing aid covers the P1, P3 areas and is aligned with the A1, A3 areas, the A1, A3 areas will squeeze the two sides of the closing aid, causing wrinkles on both sides of the closing aid, affecting the repair effect). Therefore, the two sides of the upper area are concave toward the center of the upper area, so that the two sides of the upper area are not in contact with the adjacent native leaflets, avoiding the squeezing of the two sides of the upper area by the native anterior leaflet.

[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, so that the shape retaining member can 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 valve leaflet, thereby achieving a shape support effect without causing damage to the autologous anterior valve leaflet.

[0013] As a further improvement of the present invention, the two sides of the upper area are concave arc structures. When the valve is closed, the upper area bulges outward so that the upper area replaces the P2 area of ​​the native posterior valve leaflet to match with its native anterior valve leaflet, and the two sides of the upper area make room for the native valve leaflets in the P1 and P3 areas, so that they can match with the A1 and A3 areas of the native anterior valve leaflet. This can avoid the native anterior valve 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 4-10mm, and a shape retaining member is arranged at the lower edge of the upper area. Furthermore, the height value of the upper area ranges from 4-10mm, 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 valve leaflet when the closing aid is closed, thereby effectively protecting the native valve 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 then be diverted to both sides. In order to avoid being squeezed by the anterior leaflet of the autologous valve, 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 leaflets, 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 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 chord tissue of the autologous posterior valve leaflet when opening and closing, and 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 will 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, 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, and 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 due to blood flow impact. Compared with the prior art, the advantages of the technical solution of the present application include at least the following: In the prior art, when the closing aid is in valve closure, the autologous anterior valve leaflet will squeeze the two sides of the closing aid, causing wrinkles in the closing aid, which will lead to blood accumulation in the wrinkles, thrombosis, calcification and other adverse conditions. 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 an idea 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 shape 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.

[0022] According to an idea of ​​the present application, a curling structure is provided on the left and right sides of the upper region. The advantage of such a design is that when the valve is closed, the blood will be shunted to both sides after impacting the middle position of the upper region, and in order to avoid being squeezed by the anterior valve leaflet of the native body, the two sides of the upper region are "cut off" a part. Therefore, the reflux pressure on both sides of the upper region will be relatively large, and the curling structure on both sides of the upper region can just allow the shunted blood to flow to the rear of the closing aid, effectively avoiding the reflux of blood from both sides of the upper region, avoiding squeezing and interference of the native valve leaflets, and providing effective guidance for the shunting of blood to avoid reflux.

[0023] 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 chamfers are designed to prevent the closing aid from being hooked with the chordal 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.

[0024] According to one concept of the present application, 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, so that when the closing aid is impacted by blood flow, each adjustment unit can effectively adjust the 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 impacted by different degrees of blood flow, avoiding stress concentration in certain local areas of the closing aid and causing damage to the closing aid, and after the blood flow impact fades, the closing aid can quickly return to its initial state, effectively avoiding wrinkles in the closing aid, which will lead to adverse conditions such as thrombus accumulation and calcification in the long run, and has good clinical significance.

[0025] 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

[0026] 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: Figure 1 It is a schematic diagram of the overall structure of the implant device of the present invention.

[0027] Figure 2 It is a side view of the implant device of the present invention.

[0028] Figure 3 It is a schematic diagram of the overall structure of the implantable device of the present invention positioned in the heart.

[0029] Figure 4 Schematic diagram of the curled structure diverting blood when blood flows into the upper area.

[0030] Figure 5 Schematic diagram of the mitral valve area.

[0031] Figure 6 This is a schematic diagram of the closure aid and the anterior valve leaflet coapting after the implant device is implanted.

[0032] Figure 7 It 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.

[0033] Figure 8 for Figure 7 Rear view of.

[0034] The features indicated by the numbers in the accompanying drawings are as follows: 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

[0035] 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.

[0036] 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.

[0037] 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.

[0038] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the present application.

[0039] In the present 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.

[0040] One of the purposes of the embodiments described below is to address the above-mentioned deficiencies, as well as other problems. Example

[0041] 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 clamping leaflets, shrinking rings, etc. The repair route adopted in this scheme is to replace the posterior leaflet of the native valve and increase the area of ​​​​coupling with the native anterior leaflet to reduce regurgitation. According to clinical data, the main area of ​​prolapse of the native posterior leaflet is in the P2 area, so the targeted 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 A1 and A3 areas of the native anterior leaflet 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 to 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 to the papillary muscle tissue, as shown in FIG. Figure 3 As shown, the closing aid 2 includes an upper area 21 and a lower area 22, the fixing bracket 1 is connected to the upper area 21, and one end of the adjustment mechanism 4 is connected to the lower area 22, wherein both sides of the upper area 21 are concave toward the center of the upper area 21, and a shape retaining member 23 is provided at the junction of the upper area 21 and the lower area 22, the shape retaining member 23 is provided at the lower edge of the upper area 21, and the shape retaining member 23 is in an arched shape.

[0042] In this embodiment, when the native valve is closed, from the perspective of looking down at the native valve ring from the atrium, the native front leaflet is divided into three areas A1, A2, and A3, specifically a three-section arc structure, such as Figure 5 As shown in the figure, the autologous posterior leaflet corresponds to the three areas of P1, P2, and P3. According to clinical data, the probability of lesions in the P2 area is much greater than that in the P1 and P3 areas. Therefore, we mainly repair the P2 area, and at the same time, we cannot interfere with the occlusion of the A1, A3 and P1 and P3 areas (because when the closing aid 2 covers the P1 and P3 areas and occludes the A1 and A3 areas, the A1 and A3 areas 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 area 21 are concave toward the center of the upper area 21, so that the two sides of the upper area 21 do not contact the adjacent autologous leaflets, avoiding the compression of the two sides of the upper area 21 by the autologous anterior leaflet, as shown in FIG. Figure 6 shown.

[0043] 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 valve leaflet, thereby playing a shape support effect without causing damage to the autologous anterior valve leaflet.

[0044] In this embodiment, the two sides of the upper region 21 are inwardly concave arc 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 valve leaflet and matches with its native anterior valve leaflet, while the two sides of the upper region 21 make room for the native valve leaflets in the P1 and P3 areas, so that they can match with the A1 and A3 areas of the native anterior valve leaflet. This can prevent the native anterior valve leaflet from squeezing the two sides of the closing aid 2 and the occurrence of wrinkles, while effectively repairing the regurgitation area.

[0045] 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 of the upper region 21 is in the range of 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.

[0046] 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 backwards. When the valve is closed, 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 valve leaflet, the two sides of the upper area 21 are "cut off" a part, so the reflux pressure on the two sides of the upper area 21 will be relatively large, and the curling structure 24 on the two sides of the upper area 21 can just allow the shunted blood to flow to the rear of the closing aid 2, effectively avoiding the blood from flowing back from the two sides of the upper area 21, avoiding squeezing and interference of the native valve leaflet, and providing effective guidance for the shunting of blood to avoid reflux.

[0047] In this embodiment, the width of the upper region 21 is smaller than the width of the native valve ring P2 region.

[0048] In this embodiment, the lower area 22 is generally designed as a rectangular structure, and the lower area 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 autologous posterior valve leaflet when opening and closing. In addition, the width of the lower edge of the lower area 22 does not exceed 35 mm. This is to prevent the lower area 22 from being too wide when the ventricle contracts, which may cause the lower area 22 to collide with the myocardium in the ventricle and cause damage to the myocardium.

[0049] In this embodiment, the lower edge of the lower region 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.

[0050] In this embodiment, the rigidity of the first adjustment unit 5 , the second adjustment unit 6 and the third adjustment unit 7 is greater than the rigidity of the first connecting section 8 and the second connecting section 9 .

[0051] 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.

[0052] 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 be restored to a preset shape after being deformed by blood flow impact. Figure 1 shown.

[0053] An exemplary operation process of repairing a mitral valve of an implantable device for treating valvular regurgitation in the first embodiment is as follows: 1. The delivery system is delivered through the patient's left ventricle to the left atrium via a transapical approach. 2. Positioning the fixing stent 1 at the autologous valve annulus, and further releasing the fixing member 3, so that the fixing member 3 passes through the fixing stent 1 and penetrates into the autologous valve annulus tissue to achieve anchoring; 3. The closing aid 2 is gradually released from the distal end to the proximal end, and the proximal end of the adjustment mechanism 4 is fixed to the papillary muscle. At this time, the anti-reflux prosthesis replaces the function of a single autologous valve and achieves coaptation with adjacent autologous valve leaflets; 4. Withdraw the delivery device of the implantable device for treating valvular regurgitation to complete the operation.

[0054] 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 implantable device for treating valvular regurgitation, comprising a fixing bracket, a closing aid, a fixing member and an adjusting mechanism, wherein the closing aid is anchored on atrial tissue through the fixing member, one end of the adjusting mechanism is connected to the closing aid, and one end of the adjusting mechanism is fixed on ventricular tissue or apical tissue, characterized in that: 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.

2. An implantable device for treating valvular regurgitation according to claim 1, characterized in that: The shape retaining member is arranged at the lower edge of the upper region, and the shape retaining member is in an arched shape.

3. An implantable device for treating valvular regurgitation according to claim 2, characterized in that: When the native valve is closed, the lower edge of the upper region and both sides of the upper region are not in contact with the adjacent native valve leaflets.

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

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

6. An implantable device for treating valvular regurgitation according to claim 1, characterized in that: The left and right sides of the upper region are provided with curling structures, and the curling structures enable the left and right sides of the upper region to curl backwards.

7. An 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.

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

9. An implantable device for treating valvular regurgitation according to claim 8, characterized in that: 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, 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.

10. An implantable device for treating valvular regurgitation according to claim 9, characterized in that: The rigidity of the first adjustment unit, the second adjustment unit and the third adjustment unit is greater than the rigidity of the first connecting section and the second connecting section.

11. An implantable device for treating valvular regurgitation according to claim 9, 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.

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

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