An implant that can prevent interlaminar reflux

Abstract

The application relates to the field of medical devices, in particular to an implant capable of avoiding interlayer reflux, which comprises an anchoring device, a closing aid, and an adjusting mechanism, the closing aid is fixed on atrial tissue through the anchoring device, one end of the adjusting mechanism is connected with the closing aid, and the other end of the adjusting mechanism is fixed on ventricular tissue or apical tissue, the closing aid comprises a first patch and a second patch, one side of the first patch close to the anchoring device is a root, and the other 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 direction towards the head direction; the application can effectively avoid the existence of a gap between the closing aid and the autologous valve leaflet, so that blood flowing into the gap can be prevented from being accumulated into thrombus, calcified and other adverse conditions, and the application has good clinical significance.

Description

Technical Field

[0001] This application relates to the field of medical devices, and more particularly to an implant that can prevent interlaminar reflux. Background Technology

[0002] The mitral valve is located at the left atrioventricular orifice and consists of five parts: the valve annulus, leaflets, chordae tendineae, papillary muscles, and commissural junction. Its accurate anatomical name is the mitral apparatus or mitral complex.

[0003] The tricuspid valve is located at the right atrioventricular orifice and has three approximately triangular velamentous valves. The base of the valves is attached to the fibrous annulus at the atrioventricular orifice. Functionally, the fibrous annulus, valves, chordae tendineae, and papillary muscles are visible, forming the tricuspid valve complex.

[0004] Mitral regurgitation can be divided into two types: 1. Rheumatic mitral regurgitation, mainly caused by mitral valve insufficiency, which can cause blood to flow in the opposite direction, resulting in the mixing of different blood types and a decrease in the heart's pumping and oxygen-carrying capacity. 2. Non-rheumatic mitral regurgitation, which usually refers to varying degrees of mitral regurgitation caused by abnormalities in the mitral valve itself and its surrounding anatomical structures, excluding rheumatic valvular disease. There are many causes of non-rheumatic mitral regurgitation, the most common being: mitral valve prolapse, papillary muscle dysfunction or chordae tendineae rupture, left atrial myxoma, valvular annular calcification, congenital valvular malformations, and infective endocarditis. Mitral regurgitation can also be classified into three types: functional, degenerative, and mixed. The most common are degenerative and functional mitral regurgitation. Functional mitral regurgitation is generally secondary to impaired left ventricular wall motion function, left ventricular dilation, and papillary muscle dysfunction, and is commonly seen in patients with heart failure. This group of patients also includes ischemic mitral regurgitation secondary to coronary artery disease and mitral regurgitation related to non-ischemic cardiomyopathy. Degenerative mitral regurgitation is generally considered to be caused by pathological changes in the valve structure or subvalvular structures, including abnormal extension or rupture of the chordae tendineae.

[0005] When the mitral valve becomes diseased, we usually replace the diseased posterior leaflet so that the implanted patch aligns with the anterior leaflet. For example, patent CN202210058417.8 discloses a repair device with a biomimetic leaflet shape, including a first skeleton and a closure aid. After the repair device is implanted, the first skeleton is fixed to the autologous valve annulus or atrial tissue. The closure aid can move with the movement of the autologous valve leaflet. The repair device also includes a shape retainer. One end of the shape retainer is connected to the first skeleton, and the shape retainer fits against the closure aid. When the autologous valve is in the closed state, the portion of the closure aid near the autologous valve annulus is supported by the shape retainer. While the shape-maintaining component in this patented solution can provide effective shape support for the upper part of the closure aid, its first skeleton is difficult to anchor tightly against the autologous valve annulus due to the lack of visibility during the surgical procedure. The first skeleton is usually fixed above the autologous valve annulus, which results in a space between the root region of the closure aid and the root region of the autologous valve annulus. When the valve closes, blood flows into this space and further outwards to both sides of the closure aid, causing blood backflow. Furthermore, long-term blood accumulation can lead to problems such as calcification and thrombosis in this area. Secondly, the shape-maintaining component cannot adjust the shape of the valve leaflets according to the rate of intracardiac blood flow; it can only maintain a fixed shape and lacks self-adaptive capability.

[0006] In summary, existing repair devices have at least the following technical challenges: 1. How to solve the problem of blood backflow at the root of the closure aid and the root of the autologous valve leaflet; 2. How to enable the closure aid to adaptively adjust its shape so that it fits more closely with the autologous valve leaflet. Summary of the Invention

[0007] This application is made in view of the above and other ideas.

[0008] One of the purposes of this application is to overcome the shortcomings of the prior art and provide an implant that can avoid interlaminar reflux, addressing issues such as the blood reflux between the root of the closure aid and the root of the autologous valve 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 closure aid, and an adjustment mechanism. The closure aid is fixed to the atrial tissue by the anchoring device. One end of the adjustment mechanism is connected to the closure aid and fixed to the ventricular tissue or the apical tissue. The closure aid includes a first patch and a second patch. The side of the first patch closer to the anchoring device is the root, and the side of the first patch away from the anchoring device is the head. The first patch is disposed above the second patch, and the first patch and the second patch cooperate to form a pocket structure with an opening facing the head.

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

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

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

[0013] As a further improvement of the present invention, when the autologous valve closes, blood flows into the pocket structure, causing the first patch to fill in order to achieve adaptive contact with the autologous valve leaflet.

[0014] As a further improvement of the present invention, blood flows continuously into the pocket structure, causing the first patch to fill and push towards the atrium, and the degree of pushing is different from the blood flow rate, so that the first patch can achieve adaptive contact with the autologous valve leaflet.

[0015] As a further improvement of the present invention, the second patch is fixed to the root region 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 eddies, causing blood backflow, thrombosis and other problems. Furthermore, 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, wherein 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 less 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 the width 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 provided at two side positions of the first patch to specifically prevent blood backflow from the side.

[0019] As a further improvement of the present invention, when the autologous valve closes, at least a portion of the second patch adheres to the replaced autologous valve leaflet.

[0020] As a further improvement of the present invention, the upper region of the closure aid is folded back on both sides to form a recessed portion.

[0021] As a further improvement of this invention, when the autologous valve closes, viewed from the atrium looking down at the autologous valve annulus, the anterior leaflet is divided into three regions: A1, A2, and A3, specifically a three-segment arc-shaped structure. The posterior leaflet corresponds to regions P1, P2, and P3. Clinical data shows that the probability of lesions in region P2 is much higher than in regions P1 and P3. Therefore, we primarily target the repair of region P2, while avoiding interference with the alignment of regions A1, A3, and P1, P3 (because when...). When the closure aid covers regions P1 and P3 and aligns with regions A1 and A3, regions A1 and A3 will compress the sides of the closure aid, causing wrinkles on both sides and affecting the repair effect. Therefore, the width of the upper region of the closure aid is less than or equal to the width of the autologous valve region P2, so that the sides of the upper region of the closure aid do not contact the adjacent autologous leaflets, avoiding compression of the sides of the upper region by the autologous anterior leaflet, thereby effectively avoiding adverse situations such as compression and wrinkling after the closure aid is implanted.

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

[0023] As a further improvement of the present invention, one end of the second adjustment member is connected to the second patch, the other end of the second adjustment member is fixed to the apical tissue or papillary muscle, and pulling the second adjustment member can adjust the opening size of the pocket structure.

[0024] Compared with the prior art, the advantages of the technical solution of this application include at least the following:

[0025] In existing technologies, during the anchoring of implants, due to the lack of visualization during surgery, the anchoring position of the fixation stent is generally higher than the autologous valve annulus. This results in a gap between the root of the closure aid and the root region of the autologous valve leaflet. When the valve closes, blood flows into this gap, causing blood to divert from both sides of the closure aid and leading to adverse conditions such as valve regurgitation. According to a concept of this application, the closure aid consists of a first patch and a second patch. The second patch and the first patch cooperate to form a pocket structure with an opening facing the head of the first patch. This allows blood between the root of the autologous valve leaflet and the closure aid to flow into this pocket structure when the valve closes. The continuous inflow of blood fills the pocket structure, allowing the first patch to fully bulge and fully align with the autologous valve leaflet, ensuring its anti-regurgitation performance. At the same time, the degree of bulging of the first patch changes with the intracardiac blood flow velocity, enabling the first patch to adaptively conform to the autologous valve leaflet, which has significant clinical implications.

[0026] According to one concept of this application, one end of the second adjustment member is connected to the second patch, and the other end is fixed to the apex of the heart or papillary muscle. The second patch fits the replaced autologous valve leaflet, which can effectively isolate the interlaminar space caused by the height difference between the anchoring position of the fixation bracket and the autologous valve annulus, and effectively prevent blood from entering between the closure aid and the autologous valve leaflet.

[0027] According to a concept of this application, the upper region of the valve closure aid folds backward on both sides to form a recessed portion. The advantage of this design is that when the valve closes, the blood impacts the middle of the upper region and then flows to both sides. To avoid being squeezed by the original anterior leaflet, the two sides of the upper region are "cut off" to a certain extent. Therefore, the backflow pressure on the two sides of the upper region will be relatively large. The recessed portion on both sides of the upper region can allow the shunted blood to flow to the rear of the valve closure aid, effectively preventing blood from flowing back from the two sides of the upper region. This avoids squeezing and interference from the original leaflet while providing effective guidance for the shunting of blood and preventing backflow.

[0028] The embodiments of this application can achieve other advantageous technical effects not listed one by one. These other technical effects may be partially described below and can be expected and understood by those skilled in the art after reading this application. Attached Figure Description

[0029] The above-described features and advantages, as well as other features and advantages, and the ways in which they are implemented, of these embodiments will become more apparent and the embodiments of this application will be better understood by referring to the following description in conjunction with the accompanying drawings, in which:

[0030] Figure 1 and Figure 2 This is a schematic diagram of the overall structure of the implant of the present invention.

[0031] Figure 3 This is a schematic diagram of the overall structure of the implant of the present invention positioned in the heart, where the arrows indicate the direction of blood flow.

[0032] Figure 4 for Figure 3 Enlarged view of section A, where the arrows indicate the direction of blood flow.

[0033] Figure 5 This is a schematic diagram of the mitral valve region.

[0034] Figure 6 This is a schematic diagram showing the closure aid aligning with the anterior leaflet after the implantation of the device.

[0035] Figure 7 This is a schematic diagram showing how the concave region diverts blood flow when it impacts the upper region.

[0036] Figure 8 This is a schematic diagram of an implant according to another embodiment of the present invention.

[0037] The features represented by the numbers in the attached diagram are as follows:

[0038] 1-Fixed bracket, 2-Closing aid, 21-First patch, 211-Head, 212-Root, 22-Second patch, 23-Pocket structure, 24-Opening, 3-Fixed member, 4-Adjustment mechanism, 41-First adjustment assembly, 42-Second adjustment assembly. Implementation

[0039] The details of one or more embodiments of this application will be set forth in the following description of the accompanying drawings and specific embodiments. Other features, objects, and advantages of this application will become clear from these descriptions, drawings, and claims.

[0040] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments may be other embodiments and can be implemented or performed in various ways. The examples are provided by way of explanation rather than limitation of the disclosed embodiments. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of this application without departing from the scope or spirit of this disclosure. For example, features illustrated or described as part of one embodiment may be used with another embodiment to still produce another embodiment. Therefore, this disclosure covers such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0041] Similarly, it is understood that the phrases and terms used in this document are for descriptive purposes and should not be considered restrictive. The use of “including,” “contains,” or “has,” and their variations, in this document is intended to include, in an open-ended manner, the items listed thereafter, their equivalents, and any additional items.

[0042] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0043] One of the objectives of the embodiments described below is to address the aforementioned deficiencies, as well as other problems. Example

[0044] like Figure 1 and Figure 2 The illustration shows an implant that can prevent interlaminar reflux according to an embodiment of this application, including a fixation bracket 1, a closure aid 2, a fixation member 3, and an adjustment mechanism 4. The closure aid 2 is anchored to atrial tissue by the fixation member 3. One end of the adjustment mechanism 4 is connected to the closure aid 2, and the other end is fixed to ventricular tissue or apical tissue. The closure aid 2 includes a first patch 21 and a second patch 22. The side of the first patch 21 closest to the fixation bracket 1 is the root 212, and the side of the first patch 21 furthest from the fixation bracket 1 is the head 211. The first patch 21 is positioned above the second patch 22, and the first patch 21 is connected to the second patch 22. The second patch 22 cooperates to form a pocket structure 23 with an opening 24 facing the head 211. 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, and 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, and the other end is fixed to the apical tissue or papillary muscle. Pulling the second adjustment component adjusts the size of the opening 24 of the pocket structure 23. When the autologous valve closes, blood flows into the pocket structure 23, causing the first patch 21 to fill and achieve adaptive contact with the autologous valve leaflet. Figure 3 and Figure 4 As shown.

[0045] In this embodiment, the pocket structure 23 is only provided with an opening 24 facing the head 211. That is to say, the second patch 22 is sealed to the first patch 21 on the side near the root 212 and on both the left and right sides.

[0046] In this embodiment, both the first patch 21 and the second patch 22 are made of biological pericardial materials, such as bovine pericardium or porcine pericardium.

[0047] In another embodiment, the first patch 21 and the second patch 22 may also be made of polymer materials.

[0048] In this embodiment, blood continuously flows into the pocket structure 23, causing the first patch 21 to inflate and push towards the atrium. The degree of this upward movement changes with the blood flow rate, allowing the first patch 21 to adaptively conform to the autologous valve leaflet. This enables the closure aid 2 to automatically adjust its inflation level in real time according to the patient's intracardiac blood flow rate, facilitating better alignment with the autologous valve leaflet. Figure 3 and Figure 4 As shown.

[0049] In this embodiment, the second patch 22 is fixed to the root 212 region of the first patch 21. The purpose of this design is to prevent blood from entering between the second patch 22 and the autologous valve leaflet, forming interlayer eddies, causing blood backflow, thrombosis and other problems. Furthermore, the side of the second patch 22 is connected to the side of the first patch 21.

[0050] In this embodiment, one end of the second adjustment member is connected to the second patch 22, and the other end is fixed to the apex of the heart or papillary muscle. The second patch 22 fits the replaced autologous valve leaflet, which can effectively isolate the gap space caused by the height difference between the anchoring position of the fixation bracket 1 and the autologous valve annulus, and effectively prevent blood from entering between the closure aid 2 and the autologous valve leaflet.

[0051] In this embodiment, the length of the second patch 22 is less than the length of the first patch 21.

[0052] In this embodiment, when the autologous valve closes, at least a portion of the second patch 22 adheres to the replaced autologous valve leaflet.

[0053] In this embodiment, the upper region of the closure aid 2 is folded back on both sides to form a recessed portion, such as... Figure 7 As shown.

[0054] In this embodiment, when the autologous valve closes, viewed from the atrium looking down at the autologous valve annulus, the anterior leaflet is divided into three regions: A1, A2, and A3, specifically a three-segment arc-shaped structure. The posterior leaflet corresponds to regions P1, P2, and P3. Figure 5As shown, clinical data indicates that the probability of lesions in the P2 region is much higher than in the P1 and P3 regions. Therefore, our primary focus is on repairing the P2 region. Simultaneously, we must avoid interfering with the alignment of the A1, A3, and P1, P3 regions (because when the closure aid 2 covers the P1, P3 regions and aligns with the A1, A3 regions, the A1, A3 regions will compress the sides of the closure aid 2, causing wrinkles on both sides and affecting the repair effect). Therefore, the width of the upper region of the closure aid 2 is less than or equal to the width of the autologous valve P2 region, ensuring that the sides of the upper region of the closure aid 2 do not contact the adjacent autologous leaflets, preventing compression of the upper region by the autologous anterior leaflets. This effectively avoids adverse situations such as compression and wrinkling after implantation of the closure aid 2. Figure 6 As shown.

[0055] In this embodiment, when the autologous valve is closed, the length of the second patch 22 is not shorter than the distance from the autologous valve annulus to the leaflet junction. Example

[0056] Embodiment 2 is largely the same as Embodiment 1, except that 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 specific / designated area of ​​the first patch 21.

[0057] 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 As shown.

[0058] In this embodiment, pocket structures 23 are provided on the two sides of the first patch 21 to specifically prevent blood backflow from the sides.

[0059] In this regard, the relevant construction and concept of Embodiment 2 are similar to those of Embodiment 1, and therefore will not be described again here.

[0060] The foregoing description of the embodiments described above is provided for illustrative purposes. This foregoing description is not intended to be exhaustive, nor is it intended to limit the application to the precise configurations, constructions, and / or steps disclosed. Clearly, many modifications and variations can be made in light of the teachings above. The scope of the invention and all its equivalents are intended to be defined by the appended claims.

Claims

1. An implant that prevents interlaminar reflux, comprising an anchoring device, a closure aid, and an adjustment mechanism, wherein the closure aid is fixed to atrial tissue via the anchoring device, one end of the adjustment mechanism is connected to the closure aid, and one end of the adjustment mechanism is fixed to ventricular tissue or apical tissue, characterized in that: The closing aid comprises a first patch and a second patch, a root of the first patch is close to one side of the anchoring device, a head of the first patch is away from the other side of the anchoring device, 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 towards the head direction, when the native valve is closed, blood flows into the pocket structure, so that the first patch is filled to achieve self-adaptive abutment with the native valve leaflet, the corresponding native posterior leaflet is P1, P2 and P3 three regions, P2 is the middle region, the width of the upper region of the closing aid is less than or equal to the width of the P2 region of the native valve.

2. The implant of claim 1, wherein: The pocket structure is only provided with an opening towards the head direction.

3. The implant of claim 1, wherein: The second patch is fixed at the root region of the first patch, and the side edges of the second patch are connected with the side edges of the first patch.

4. The implant of claim 1, wherein: The adjusting mechanism comprises a first adjusting assembly and a second adjusting assembly, the first adjusting assembly is connected with the first patch, and the second adjusting assembly is connected with the second patch.

5. The implant of claim 3, wherein: The length of the second patch is less than the length of the first patch.

6. The implant of claim 1, wherein: When the native valve is closed, at least part of the second patch abuts the replaced native valve leaflet.

7. The implant of claim 1, wherein: The two sides of the upper region of the closing aid are folded back and form a nest-shaped part.

8. The implant of claim 6, wherein: When the native valve is closed, the length of the second patch is not shorter than the distance from the native annulus to the junction of the leaflet.

9. The implant of claim 4, wherein: One end of the second adjusting assembly is connected with the second patch, the other end of the second adjusting assembly is fixed on the apex tissue or papillary muscle, and pulling the second adjusting assembly can adjust the opening size of the pocket structure.

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