Implant capable of avoiding interlayer reflux

Abstract

The invention relates to the field of medical instruments, in particular to an implant capable of avoiding interlayer regurgitation, which comprises an anchoring device, a closure assisting part and an adjusting mechanism, the closure assisting part is fixed on atrial tissue through the anchoring device, one end of the adjusting mechanism is connected with the closure assisting part, and the other end of the adjusting mechanism is connected with the closure assisting part. One end of the adjusting mechanism is fixed to ventricular tissue or cardiac apex tissue, the closure assisting piece comprises a first patch and a second patch, the side, close to the anchoring device, of the first patch is a root part, the side, away from the anchoring device, of the first patch is a head part, the first patch is arranged above the second patch, and the second patch is arranged above the head part. The first patch and the second patch are matched to form a pocket structure with an opening facing the head; the closure assisting device can effectively avoid the unfavorable conditions of thrombus accumulation, calcification and the like caused by the fact that blood flows into a gap due to the gap between the closure assisting part and the autologous valve leaflet, and has very good clinical significance.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to an implant capable of avoiding interlaminar reflux. 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 CN202210058417.8 discloses a repair device with a bionic leaflet morphology, including a first skeleton and a closing aid. After the repair device is implanted, the first skeleton is fixed to the native valve annulus or atrial tissue, and the closing aid can move with the movement of the native valve leaflet. The repair device also includes a shape retaining member, one end of which is connected to the first skeleton, and the shape retaining member is attached to the closing aid. When the native valve is in a closed state, the part of the closing aid close to the native valve annulus is supported by the shape retaining member. Although the shape retaining member in the patent solution can provide effective shape support for the upper part of the closing aid, its first skeleton is difficult to be anchored close to the native valve ring due to the invisible reason during the surgical operation. The fixed position of the first skeleton is usually above the native valve ring, which will cause partial space between the root area of ​​the closing aid and the root area of ​​the native valve ring. When the valve is closed, blood will flow into this space and further flow out to both sides of the closing aid, causing blood reflux. In addition, long-term blood accumulation will also cause calcification, thrombosis and other problems in this area. Secondly, the shape retaining member cannot adjust the shape of the valve leaflet according to the rate of intracardiac blood flow, but can only maintain an inherent shape and does not have adaptive ability.

[0006] In summary, the repair devices in the prior art have at least the following technical pain points: 1. How to solve the problem of blood flow backflow between the root of the closing aid and the root of the native valve leaflet; 2. How to make the closing aid have the ability to adaptively adjust its shape so that it fits more closely with the native valve leaflet. 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 that can avoid interlaminar reflux, for example, in view of the problem of blood flow reflux between the root of the closing aid and the root of the native valve leaflet in the prior art.

[0009] The technical solution adopted to solve the technical problem of the present invention is to provide an implant that can avoid interlaminar reflux, including an anchoring device, a closing aid, and an adjustment mechanism, wherein the closing aid is fixed to the atrial tissue through the anchoring device, one end of the adjustment mechanism is connected to the closing aid, and one end of the adjustment mechanism is fixed to the ventricular tissue or the apical tissue, the closing aid includes a first patch and a second patch, the side of the first patch close to the anchoring device is a root, and the side of the first patch away from the anchoring device is a head, wherein the first patch is arranged above the second patch, and the first patch and the second patch cooperate to form a pocket structure with the opening facing the direction of the head.

[0010] As a further improvement of the present invention, the anchoring device includes a fixing bracket and a fixing piece, wherein the fixing bracket is a sheet-shaped bracket or a ring-shaped bracket, and the fixing piece is an anchoring needle.

[0011] As a further improvement of the present invention, the pocket structure is only provided with an opening facing the head direction, that is, one side of the second patch close to the root and both the left and right sides are sealed and connected to the first patch.

[0012] As a further improvement of the present invention, two sides of the second patch are connected to two sides of the first patch.

[0013] As a further improvement of the present invention, when the native valve is closed, blood flows into the pocket structure, so that the first patch is filled to achieve adaptive contact with the native valve leaflet.

[0014] As a further improvement of the present invention, blood flows continuously into the pocket structure, so that the first patch is filled and pushed toward the atrium, and the degree of pushing changes with the blood flow rate, so that the first patch can achieve adaptive adhesion with the native valve leaflet.

[0015] As a further improvement of the present invention, the second patch is fixed to the root area of ​​the first patch. The purpose of this design is to prevent blood from entering between the second patch and the autologous valve leaflet, forming interlayer vortices, causing blood reflux, thrombosis and other problems, and the side of the second patch is connected to the side of the first patch.

[0016] As a further improvement of the present invention, the adjustment mechanism includes a first adjustment component and a second adjustment component, the first adjustment component is connected to the first patch, and the second adjustment component is connected to the second patch.

[0017] As a further improvement of the present invention, the length of the second patch is smaller than the length of the first patch.

[0018] As a further improvement of the present invention, the width of the second patch is smaller than that of the first patch, and the second patch is fixed to a specific area of ​​the first patch to form a regional pocket structure. For example, a pocket structure is set at two side positions of the first patch to specifically prevent the backflow of blood on the sides.

[0019] As a further improvement of the present invention, when the native valve is closed, at least a portion of the second patch fits with the replaced native valve leaflet.

[0020] As a further improvement of the present invention, two sides of the upper region of the closing aid are folded backwards to form a recessed portion.

[0021] As a further improvement of the present invention, when the autologous valve is closed, from the perspective of looking down at the autologous valve ring from the atrium, the autologous anterior valve leaflet is divided into three areas A1, A2, and A3, specifically a three-segment arc structure, and the autologous posterior valve 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 A1, A3 and P1, P3 areas (because when When the closing aid covers the P1 and P3 regions and matches the A1 and A3 regions, the A1 and A3 regions will squeeze the two sides of the closing aid, causing wrinkles on both sides of the closing aid, affecting the repair effect). Therefore, the width of the upper region of the closing aid is less than or equal to the width of the native valve P2 region, so that both sides of the upper region of the closing aid are not in contact with the adjacent native valve leaflets, avoiding squeezing of the two sides of the upper region by the native front valve leaflets, thereby effectively avoiding unfavorable situations such as squeezing and wrinkling of the closing aid after implantation.

[0022] As a further improvement of the present invention, when the native valve is closed, the length of the second patch is not shorter than the distance from the native valve ring to the junction of the leaflets.

[0023] As a further improvement of the present invention, one end of the second adjusting member is connected to the second patch, the other end of the second adjusting member is fixed on the apical tissue or the papillary muscle, and the opening size of the pocket structure can be adjusted by pulling the second adjusting member. 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 implant is anchored, the anchoring position of the fixing bracket is generally higher than the native valve ring because the operation is not visible during the operation. This results in a gap between the root of the closing aid and the root area of ​​the native valve leaflet, which causes blood to flow into the gap when the valve is closed, resulting in blood shunting from both sides of the closing aid, and adverse conditions such as valve reflux. According to an idea of ​​the present application, the closing aid is divided into a first patch and a second patch, and the second patch cooperates with the first patch to form a pocket structure with an opening facing the head of the first patch, so that when the valve is closed, the blood between the root of the native valve leaflet and the closing aid will flow into the pocket structure, and the continuous inflow of blood makes the pocket structure full, thereby enabling the first patch to fully swell and fully match the native valve leaflet, ensuring its anti-reflux performance. At the same time, the degree of bulging of the first patch will also change with the flow rate of blood in the heart, so that the first patch can produce the function of adaptively fitting the native valve leaflet, which has good clinical significance.

[0024] According to one concept of the present application, one end of the second adjustment member is connected to the second patch, and the other end is fixed on the apex or the papillary muscle. The second patch fits the replaced native valve leaflet, which can effectively isolate the interlayer space caused by the height difference between the anchoring position of the fixed stent and the native valve ring, and effectively prevent blood from entering between the closing aid and the native valve leaflet.

[0025] According to an idea of ​​the present application, both sides of the upper area of ​​the closing aid are folded backwards to form a recessed portion. The advantage of such a design is that when the valve is closed, the blood will be diverted to both sides after impacting the middle position of the upper area, and in order to avoid being squeezed by the native anterior valve leaflet, both 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 recessed portions 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 by the native valve leaflet, and providing effective guidance for the shunting of blood to avoid reflux.

[0026] 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

[0027] 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 and Figure 2 It is a schematic diagram of the overall structure of the implant of the present invention.

[0028] Figure 3 This is a schematic diagram of the overall structure of the implant of the present invention positioned in the heart, wherein the direction of the arrow indicates the direction of blood flow.

[0029] Figure 4 for Figure 3 The enlarged view of part A in the middle shows the direction of blood flow.

[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 Schematic diagram of the dimples diverting blood when blood impacts the upper area.

[0033] Figure 8 FIG. 1 is a schematic diagram of an implant according to another embodiment of the present invention.

[0034] The features indicated by the numbers in the accompanying drawings are as follows: 1-fixing bracket, 2-closing aid, 21-first patch, 211-head, 212-root, 22-second patch, 23-pocket structure, 24-opening, 3-fixing member, 4-adjusting mechanism, 41-first adjusting component, 42-second adjusting component. 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] One of the purposes of the embodiments described below is to address the above-mentioned deficiencies, as well as other problems. Example

[0040] like Figure 1 and Figure 2 As shown, an implant capable of avoiding interlaminar reflux according to an embodiment of the present application is illustrated, comprising a fixing bracket 1, a closing aid 2, a fixing member 3 and an adjusting mechanism 4, wherein the closing aid 2 is anchored on the atrial tissue through the fixing member 3, one end of the adjusting mechanism 4 is connected to the closing aid 2, and one end of the adjusting mechanism 4 is fixed on the ventricular tissue or the apical tissue, the closing aid 2 comprises a first patch 21 and a second patch 22, wherein a side of the first patch 21 close to the fixing bracket 1 is a root 212, and a side of the first patch 21 away from the fixing bracket 1 is a head 211, wherein the first patch 21 is arranged above the second patch 22, and the first patch 21 and the second patch 22 are connected to each other. The second patch 22 cooperates to form a pocket structure 23 with an opening 24 facing the direction of the head 211, wherein the adjustment mechanism 4 includes a first adjustment component 41 and a second adjustment component 42, the first adjustment component 41 is connected to the first patch 21, the second adjustment component 42 is connected to the second patch 22, one end of the second adjustment component is connected to the second patch 22, the other end of the second adjustment component is fixed to the apical tissue or the papillary muscle, and the size of the opening 24 of the pocket structure 23 can be adjusted by pulling the second adjustment component, when the native valve is closed, blood flows into the pocket structure 23, so that the first patch 21 is filled to achieve adaptive adhesion with the native valve leaflet, such as Figure 3 and Figure 4 shown.

[0041] In this embodiment, the pocket structure 23 is only provided with an opening 24 facing the head 211 , that is, the second patch 22 is sealedly connected to the first patch 21 on one side close to the root 212 and on both the left and right sides.

[0042] In this embodiment, both the first patch 21 and the second patch 22 are made of biological pericardial material, such as bovine pericardium or porcine pericardium.

[0043] In another embodiment, the first patch 21 and the second patch 22 may also be made of polymer materials.

[0044] In this embodiment, blood flows continuously into the pocket structure 23, so that the first patch 21 is filled and pushed toward the atrium, and the degree of pushing changes with the blood flow rate, so that the first patch 21 can achieve adaptive contact with the native valve leaflet, which enables the closing aid 2 to automatically adjust its bulging degree according to the blood flow rate in the patient's heart in real time, so as to better achieve apposition with the native valve leaflet. Figure 3 and Figure 4 shown.

[0045] In this embodiment, the second patch 22 is fixed to the root 212 area of ​​the first patch 21. The purpose of this design is to prevent blood from entering between the second patch 22 and the native valve leaflet and forming interlayer vortexes, causing blood reflux, thrombosis and other problems. In addition, the side of the second patch 22 is connected to the side of the first patch 21.

[0046] In this embodiment, one end of the second adjusting member is connected to the second patch 22, and the other end is fixed on the apex or the papillary muscle. The second patch 22 fits the replaced native valve leaflet, which can effectively isolate the interlayer space caused by the height difference between the anchoring position of the fixed stent 1 and the native valve ring, and effectively prevent blood from entering between the closing aid 2 and the native valve leaflet.

[0047] In this embodiment, the length of the second patch 22 is smaller than the length of the first patch 21 .

[0048] In this embodiment, when the native valve is closed, at least a portion of the second patch 22 is in contact with the replaced native valve leaflet.

[0049] In this embodiment, both sides of the upper region of the closing aid 2 are folded back to form a recessed portion. Figure 7 shown.

[0050] 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-segment arc structure, and the native posterior leaflet corresponds to three areas P1, P2, and P3. Figure 5As shown, 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 2 covers the P1, P3 areas and aligns with the A1, A3 areas, the A1, 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 width of the upper area of ​​the closing aid 2 is less than or equal to the width of the native valve P2 area, so that both sides of the upper area of ​​the closing aid 2 do not contact the adjacent native valve leaflets, avoiding the squeezing of the two sides of the upper area by the native front valve leaflets, thereby effectively avoiding the unfavorable situations such as squeezing and wrinkling of the closing aid 2 after implantation. Figure 6 shown.

[0051] In this embodiment, when the native valve is closed, the length of the second patch 22 is not shorter than the distance from the native valve ring to the junction of the valve leaflets. Example

[0052] The second embodiment is substantially the same as the first embodiment, except that in this embodiment the width of the second patch 22 is smaller than the width of the first patch 21 , and the second patch 22 is only disposed in a certain specific / specified area of ​​the first patch 21 .

[0053] In this embodiment, the width of the second patch 22 is smaller than the width of the first patch 21, and the second patch 22 is fixed to a specific area of ​​the first patch 21 to form a regional pocket structure 23, such as Figure 8 shown.

[0054] In this embodiment, pocket structures 23 are provided at two side positions of the first patch 21 to specifically prevent the backflow of blood at the side.

[0055] In this regard, the relevant structure and concept of the second embodiment are similar to those of the first embodiment, and thus will not be described again here.

[0056] 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 implant capable of preventing interlaminar reflux, comprising an anchoring device, a closing aid, and an adjusting mechanism, wherein the closing aid is fixed to atrial tissue via the anchoring device, one end of the adjusting mechanism is connected to the closing aid, and one end of the adjusting mechanism is fixed to ventricular tissue or apical tissue, characterized in that: The closing aid comprises a first patch and a second patch, wherein the side of the first patch close to the anchoring device is a root, and the side of the first patch away from the anchoring device is a head, wherein the first patch is arranged above the second patch, and the first patch and the second patch cooperate to form a pocket structure with an opening facing the head direction.

2. An implant capable of avoiding interlaminar reflux according to claim 1, characterized in that: The pocket structure is only provided with an opening facing the head.

3. An implant capable of avoiding interlaminar reflux according to claim 1, characterized in that: When the native valve is closed, blood flows into the pocket structure, causing the first patch to fill up and achieve adaptive contact with the native valve leaflet.

4. An implant capable of avoiding interlaminar reflux according to claim 1, characterized in that: The second patch is fixed to the root area of ​​the first patch, and the side edge of the second patch is connected to the side edge of the first patch.

5. An implant capable of avoiding interlaminar reflux according to claim 1, characterized in that: The adjustment mechanism includes a first adjustment component and a second adjustment component, the first adjustment component is connected to the first patch, and the second adjustment component is connected to the second patch.

6. An implant capable of avoiding interlaminar reflux according to claim 4, characterized in that: The length of the second patch is smaller than the length of the first patch.

7. An implant capable of avoiding interlaminar reflux according to claim 1, characterized in that: When the native valve is closed, at least a portion of the second patch is in contact with the replaced native valve leaflet.

8. An implant capable of avoiding interlaminar reflux according to claim 1, characterized in that: Both sides of the upper region of the closing aid are folded back to form a recessed portion.

9. An implant capable of avoiding interlaminar reflux according to claim 7, characterized in that: The width of the upper region of the closing aid is less than or equal to the width of the native valve P2 region.

10. An implant capable of avoiding interlaminar reflux according to claim 7, characterized in that: When the native valve is closed, the length of the second patch is not shorter than the distance from the native valve ring to the junction of the valve leaflets.

11. An implant capable of avoiding interlaminar reflux according to claim 5, characterized in that: One end of the second adjusting member is connected to the second patch, and the other end of the second adjusting member is fixed on the apical tissue or the papillary muscle, and the opening size of the pocket structure can be adjusted by pulling the second adjusting member.

Images