Repair instrument capable of avoiding interlayer reflux

Abstract

The invention relates to the field of medical instruments, in particular to a repair instrument capable of avoiding interlayer reflux, which comprises a closure assisting part and an anchoring device used for fixing the closure assisting part on atrial tissue, the closure assisting part comprises a first patch and a second patch, one side, close to the anchoring device, of the first patch is a root part, and the other side, close to the anchoring device, of the second patch is a root part; the side, away from the anchoring device, of the first patch is a head, the first patch is arranged above the second patch, the first patch and the second patch are matched to form a pocket structure with an opening facing the head, and in the natural state, the pocket structure is in an open state. 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 a repair device 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 a repair device 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 a repair device that can avoid interlaminar reflux, including a closing aid and an anchoring device for fixing the closing aid on the atrial tissue, the closing aid including 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, the first patch and the second patch cooperate to form a pocket structure with an opening facing the head direction, and, in a natural state, the pocket structure is in an expanded state.

[0010] As a further improvement of the present invention, after the repair device is implanted, the second patch always fits the replaced native valve leaflet; this ensures that there is no interlayer gap between the closing aid and the native valve leaflet, effectively preventing blood from entering between the closing aid and the native valve leaflet, causing adverse conditions such as blood accumulation, reflux and tissue calcification.

[0011] As a further improvement of the present invention, the repair device further comprises an adjustment mechanism, one end of which is connected to the first patch, and the other end of which is fixed on the ventricular tissue or the apical tissue.

[0012] 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.

[0013] As a further improvement of the present invention, when the fixing bracket is a sheet-shaped bracket, the fixing bracket is composed of three diamond-shaped grids, and each diamond-shaped grid is correspondingly configured with an anchoring needle.

[0014] As a further improvement of the present invention, when the fixed stent is an annular stent, the fixed stent is a self-expanding stent, and after being released, the fixed stent is supported at the native valve ring.

[0015] As a further improvement of the present invention, 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.

[0016] 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.

[0017] 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.

[0018] As a further improvement of the present invention, a supporting structure is provided in the pocket structure, and the supporting structure is arranged on both sides of the second patch.

[0019] As a further improvement of the present invention, the support structure includes a plurality of support wires, and the support wires include a first support portion, a second support portion, and a spring segment arranged between the first support portion and the second support portion.

[0020] 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.

[0021] 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.

[0022] As a further improvement of the present invention, the length of the second patch is smaller than the length of the first patch.

[0023] 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.

[0024] 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.

[0025] As a further improvement of the present invention, the width of the upper region of the closing aid is less than or equal to the width of the native valve P2 region.

[0026] 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 valve leaflets. 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 repair device is anchored, the anchoring position of the fixed support 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. When the valve is closed, blood will flow into the gap, causing blood to be shunted from both sides of the closing aid, and the valve will have adverse conditions such as regurgitation. 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. The support structure allows the pocket structure to remain in an expanded state, so that after the closing aid is implanted, its second patch can fit the replaced autologous valve leaflet. At the same time, when the autologous valve is closed, it can ensure that blood flows into the pocket structure. The continuous inflow of blood makes the pocket structure full, so that the first patch can fully swell and fully match with the autologous valve leaflet, ensuring its anti-reflux performance. At the same time, the degree of swelling 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 autologous valve leaflet, which has great clinical significance.

[0027] According to one concept of the present application, the support structure has an adaptive height adjustment function, which can ensure that its second patch fits the native valve leaflet and prevent the support structure from causing damage to the native valve leaflet and its annular tissue due to excessive rigidity.

[0028] 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.

[0029] 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

[0030] 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 an overall schematic diagram of the repair device of the present invention.

[0031] Figure 3 It is a schematic side view of the support wire in the repair device of the present invention.

[0032] Figure 4 It is a top view schematic diagram of the support wire in the repair device of the present invention.

[0033] Figure 5 This is a schematic diagram of the overall structure of the repair device of the present invention positioned in the heart, wherein the direction of the arrow indicates the direction of blood flow.

[0034] Figure 6 for Figure 5 The enlarged view of part A in the middle shows the direction of blood flow.

[0035] Figure 7 This is a schematic diagram of the closure aid and the anterior valve leaflet coapting after the implant device is implanted.

[0036] Figure 8 Schematic diagram of the dimples diverting blood when blood impacts the upper area.

[0037] Fig. 9 It is a schematic diagram of a closing aid in another embodiment of the present invention.

[0038] 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, 5-supporting structure, 51-supporting wire, 511-first supporting part, 512-second supporting part, 513-spring segment. Implementation

[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 can be clearly seen from these descriptions, drawings and claims. 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.

[0040] 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.

[0041] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the present application.

[0042] One of the purposes of the embodiments described below is to address the above-mentioned deficiencies, as well as other problems. Example

[0043] like Figure 1 and Figure 2 As shown, a repair device 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, the side of the first patch 21 close to the fixing bracket 1 is a root 212, and the side of the first patch 21 away from the fixing bracket 1 is a head The first patch 21 is arranged above the second patch 22, and the first patch 21 cooperates with the second patch 22 to form a pocket structure 23 with an opening 24 facing the direction of the head 211, and in a natural state, the pocket structure 23 is in an open state. When the repair device is implanted and the native valve is closed, the second patch 22 fits the native posterior leaflet, and blood continues to flow into the pocket structure 23, making the pocket structure 23 filled, and the first patch 21 bulges toward the atrium, and further matches with the native anterior leaflet, such as Figure 5 and Figure 6 As shown, not only the interlaminar space caused by the height difference between the anchoring position and the native valve ring is eliminated, preventing blood from entering between the closing aid 2 and the native valve leaflet, thereby shunting to both sides of the closing aid 2 and causing backflow, but also the first patch 21 can adjust the degree of bulging according to the flow rate of blood, so as to better achieve alignment with the native anterior valve leaflet.

[0044] 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.

[0045] In another embodiment, the first patch 21 and the second patch 22 may also be made of polymer materials.

[0046] In this embodiment, after the repair device is implanted, the second patch 22 always fits the replaced native valve leaflet; this ensures that there is no interlayer gap between the closing aid 2 and the native valve leaflet, effectively preventing blood from entering between the closing aid 2 and the native valve leaflet, causing adverse conditions such as blood accumulation, reflux and tissue calcification.

[0047] In this embodiment, the second patch 22 is fixed to the root 212 area of ​​the first patch 21 , and the side edge of the second patch 22 is connected to the side edge of the first patch 21 .

[0048] 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.

[0049] In this embodiment, if Figures 2 to 4 As shown, a support structure 5 is provided in the pocket structure 23 , and the support structure 5 is arranged on both sides of the second patch 22 .

[0050] In this embodiment, the support structure 5 includes a plurality of support wires 51, and the support wires 51 include a first support portion 511, a second support portion 512, and a spring segment 513 arranged between the first support portion 511 and the second support portion 512. The spring segment 513 can be compressed to form. When the repair device is implanted, the second patch 22 fits the native valve leaflet, and the spring segment 513 is in a compressed state, which makes the second patch 22 always fit the native valve leaflet when the native valve is opened or closed. In addition, the deformation of the spring segment 513 can prevent the support structure 5 from being too rigid, thereby preventing damage to the closing aid 2 or the native valve leaflet, thereby ensuring the safety of the device.

[0051] In this embodiment, when the native valve is closed, blood flows into the pocket structure 23, so that the first patch 21 is filled to achieve adaptive contact with the native valve leaflet.

[0052] 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 adhesion 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 alignment with the native valve leaflet.

[0053] In this embodiment, the length of the second patch 22 is smaller than the length of the first patch 21 .

[0054] In this embodiment, both sides of the upper region of the closing aid 2 are folded back to form a recessed portion. Figure 8 shown.

[0055] In this embodiment, 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 occlusion of the A1, A3 and P1, P3 areas (because when the closing aid 2 covers When the P1 and P3 regions are 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 width of the upper region of the closing aid 2 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 2 do not contact the adjacent native valve leaflets, avoiding the squeezing of the two sides of the upper region 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 7 shown.

[0056] In this embodiment, the width of the upper region of the closing aid 2 is less than or equal to the width of the native valve P2 region.

[0057] 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

[0058] 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 .

[0059] 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 Fig. 9 shown.

[0060] 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.

[0061] 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.

[0062] 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. A repair device capable of avoiding interlaminar reflux, comprising a closure aid and an anchoring device for fixing the closure aid on atrial 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 toward the head, and, in a natural state, the pocket structure is in an expanded state.

2. A repair device capable of avoiding interlaminar backflow according to claim 1, characterized in that: The anchoring device comprises 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.

3. A repair device capable of avoiding interlaminar backflow according to claim 1, characterized in that: The second patch always adheres to the replaced native valve leaflet.

4. A repair device capable of avoiding interlaminar backflow according to claim 1, characterized in that: A supporting structure is provided in the pocket structure, and the supporting structure is arranged on both sides of the second patch.

5. A repair device capable of avoiding interlaminar backflow according to claim 4, characterized in that: The support structure includes a plurality of support wires, wherein the support wires include a first support portion, a second support portion, and a spring segment disposed between the first support portion and the second support portion.

6. A repair device capable of avoiding interlaminar backflow 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.

7. A repair device capable of avoiding interlaminar backflow 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.

8. A repair device capable of avoiding interlaminar backflow according to claim 1, characterized in that: The length of the second patch is smaller than the length of the first patch.

9. A repair device capable of avoiding interlaminar backflow 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.

10. A repair device capable of avoiding interlaminar backflow according to claim 9, 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.

11. A repair device capable of avoiding interlaminar backflow according to claim 9, 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.

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