A valve prosthesis for treating a tricuspid valve

Abstract

The application belongs to the field of medical devices, and particularly relates to a valve prosthesis for treating a tricuspid valve, comprising a stent and artificial valve leaflets, wherein the stent comprises a braided ring and a valve sewing segment, the braided ring is connected with the valve sewing segment, the braided ring comprises a ventricular part, an annulus part and an atrial part, the atrial part comprises a septal annulus segment, an anterior annulus segment and a posterior annulus segment, the anterior annulus segment and the posterior annulus segment are both provided with close-fitting structures, the close-fitting structures enable the edges of the anterior annulus segment and the posterior annulus segment to be pressed towards the proximal end direction, the edges of the anterior annulus segment and the posterior annulus segment are in a wavy shape, the edges of the middle region of the anterior annulus segment and the middle region of the posterior annulus segment are at wave trough positions, the edges of the end of the anterior annulus segment and the end of the posterior annulus segment are at wave crest positions, and when the native valve is opened and closed, the edge height of the middle region of the anterior annulus segment and the edge height of the middle region of the posterior annulus segment are always lower than the edge height of the end of the anterior annulus segment and the edge height of the end of the posterior annulus segment.

Description

Technical Field

[0001] This application belongs to the field of medical devices, specifically relating to a valve prosthesis for treating tricuspid valve. Background Technology

[0002] Tricuspid regurgitation is generally caused by pulmonary hypertension, right ventricular enlargement, and tricuspid annular dilation. Clinically, it often presents with symptoms of the underlying cause of tricuspid regurgitation (left heart failure, pulmonary hypertension, etc.). After the onset of tricuspid regurgitation, symptoms of right heart failure such as fatigue, ascites, edema, liver pain, indigestion, and loss of appetite worsen. Mild tricuspid regurgitation may not present with obvious clinical symptoms, but severe regurgitation requires surgical treatment.

[0003] Traditional treatments for mitral and tricuspid valve disease include medication for mild to severe regurgitation and surgical procedures when indicated. Surgical procedures include valve replacement and valve repair. However, typical open-heart surgery is highly invasive, requires cardiopulmonary bypass, and carries a high risk of complications and infection. Many patients cannot tolerate the significant surgical risks and are left with no choice but to await death.

[0004] Patent CN106264793B discloses an adaptive heart valve prosthesis, which includes a stent and an artificial valve. The stent comprises a leak-proof ring and a valve suture segment. The leak-proof ring is connected to the valve suture segment, and the artificial valve is fixedly connected to the valve suture segment. The valve suture segment is at least partially located between the patient's own valve leaflets. In a cross-section perpendicular to the central axis of the artificial valve, the cross-sectional area of ​​the valve suture segment is smaller than the cross-sectional area of ​​the patient's own valve annulus, so that the valve suture segment does not directly radially expand the patient's own valve annulus. In a free state, the cross-sectional area of ​​the leak-proof ring is larger than the cross-sectional area of ​​the patient's own valve annulus. The leak-proof ring can conform to the uneven contour of the atrial cavity wall or the patient's own valve annulus. Although the leak-proof ring in this technical solution can cover the entire autologous valve annulus with its large cross-sectional area, the outer peripheral edge of the leak-proof ring cannot completely fit the autologous valve annulus, resulting in paravalvular leakage. In particular, the leak-proof ring has an eccentric structural design to adapt to the fixed position of the stent, which makes the area of ​​the anterior and posterior valve regions corresponding to the leak-proof ring larger. The large area of ​​the leak-proof ring makes its fit worse, resulting in more serious paravalvular leakage.

[0005] Patent CN201922307893.5 discloses an interventional artificial heart valve and medical device, including a valve stent and an anchoring part. The valve stent has a body segment and an inflow end skirt segment. The body segment includes multiple circumferentially arranged support parts. At least some of the support parts extend radially outward and toward the inflow end. The anchoring part includes at least two anchors. The anchors have an arc-shaped section, an auxiliary section, and a connecting part. The free end of the arc-shaped section has a connecting part, which can be detachably connected to a connecting element. The auxiliary section is connected to the arc-shaped section and is located on the side of the arc-shaped section closer to the outflow end and closer to the body segment, for constraining the human heart valve. In this technical solution, the outer periphery of the skirt section has a downward-curving structure, which is used to anchor the autologous valve annulus in conjunction with the anchoring part. Although this can play a certain role in preventing paravalvular leakage, the skirt section is composed of several main support rods, which means that the skirt section cannot completely fit the autologous valve annulus. Or, even after the skirt section fits the autologous valve annulus, the gaps between adjacent support rods are large, causing the gap portion to detach from the autologous valve annulus during the heart's beating, leading to severe paravalvular leakage. Furthermore, the degree of regurgitation differs between the two ends and the central region of the autologous valve leaflet. For example, the degree of regurgitation is greater in the central region of the leaflet than in the two ends. In this solution, the gaps between adjacent support rods of the skirt section are large, and the support rods do not fall on the valve annulus corresponding to the central region of the leaflet, or only one or two support rods fall on the valve annulus corresponding to the central region of the leaflet. This results in insufficient fit between the skirt section and the valve annulus corresponding to the central region of the leaflet, making paravalvular leakage more likely to occur during the continuous pumping of blood by the heart.

[0006] Patent CN201910045807.X discloses a prosthetic heart valve, comprising at least two valve components, a seal covering the valve components, and a sealing structure. A spatial gap is formed between the valve components covered by the seal. The end face of the sealing structure is closed and connected to the end of the seal, thereby forming a closed space. While this patented technical solution can close the open end facing the blood flow between the two valve components, thus forming a closed space and preventing blood stasis and thrombosis, a gap still exists between the prosthetic valve leaflet and the sealing structure when the valve is open. This causes blood to swirl between the prosthetic valve leaflet and the sealing structure, leading to blood stasis and inability to drain in time, eventually resulting in thrombosis.

[0007] Therefore, those skilled in the art are dedicated to developing a valve prosthesis for the treatment of tricuspid valve, which can fit tightly against the autologous valve annulus after implantation to avoid paravalvular leakage; at the same time, it can also prevent blood from pooling in the ventricle between the artificial leaflet and the anti-leakage ring, thereby avoiding thrombosis.

[0008] Application content

[0009] The technical problem to be solved by the present invention is to provide a valve prosthesis for the treatment of tricuspid valve, which can fit tightly against the autologous valve annulus after implantation to avoid paravalvular leakage; at the same time, it can also prevent blood from accumulating in the ventricle between the artificial valve leaflet and the anti-leakage ring, thereby avoiding the formation of thrombi.

[0010] To solve the above-mentioned technical problems, this application provides the following technical solution:

[0011] According to one aspect of the present invention, a valve prosthesis for treating tricuspid valve disease includes a stent and an artificial leaflet. The stent includes a braided ring and a valve suture segment, the braided ring being connected to the valve suture segment, and the artificial leaflet being fixed within the valve suture segment. The cross-sectional area of ​​the braided ring is larger than that of the autologous valve annulus. The braided ring includes a ventricular portion, a valve annulus portion, and an atrial portion. The atrial portion includes a septal valve annulus segment, an anterior valve annulus segment, and a posterior valve annulus segment. Both the anterior and posterior valve annulus segments are provided with a close-fitting structure, the close-fitting structure causing the edges of the anterior and posterior valve annulus segments to be pressed downward proximally. After the anterior and posterior annular segments of the valve are laid flat, the edges of the anterior and posterior annular segments are wavy. The edges of the middle regions of the anterior and posterior annular segments are at the troughs, while the edges of the ends of the anterior and posterior annular segments are at the peaks. When the valve prosthesis is installed and the autologous valve opens and closes, the height of the edges of the middle regions of the anterior and posterior annular segments is always lower than the height of the edges of the ends of the anterior and posterior annular segments, and the edge of the atrium is always in close contact with the autologous valve annulus or atrial tissue.

[0012] The objective of this invention can also be further achieved through the following technical solutions:

[0013] According to one embodiment, the braided ring includes a support skeleton and a fabric layer. The support skeleton is composed of multiple support units, which are interwoven at the atrial position. During the opening and closing of the autologous valve, the autologous valve ring undulates axially, and the edge portion of the braided ring is always in close contact with the atrial tissue.

[0014] According to one embodiment, the valve prosthesis further includes a fixation device and an anchor, one end of the fixation device being connected to the valve suture segment, and the other end of the fixation device being fixed to the interventricular septum tissue via the anchor.

[0015] According to one embodiment, after the valve prosthesis is implanted, the close-fitting structure conforms to the autologous valve annulus, and the edge of the atrial portion abuts against the patient's atrial wall; the cross-sectional area of ​​the braided ring is larger than the cross-sectional area of ​​the autologous valve annulus, and the close-fitting structure conforms to the valve annulus. At the same time, the edge of the atrial portion abuts against the patient's atrial wall, which can better ensure the sealing of the braided ring.

[0016] According to one embodiment, the cross-sectional area of ​​each of the septal annular segments is smaller than the cross-sectional area of ​​the anterior annular segment and the posterior annular segment; the fixing device is fixed to the ventricular septum by an anchor, the ventricular septum is located close to the septal annular segment, and in order to ensure the stability of the valve suture segment, the valve suture segment is placed close to the septal annular segment.

[0017] According to one embodiment, the rigidity of the septal annulus segment is less than that of the anterior annulus segment and the posterior annulus segment. The septal annulus segment is located close to the ventricular septum tissue. Since the fixation device is fixed to the ventricular septum by anchors, the rigidity of the septal annulus segment is relatively small, which avoids damage to the tissue at the septal annulus after implantation and also allows the septal annulus segment to fit the tissue at the septal annulus more closely.

[0018] According to one embodiment, the density of the support unit of the septal annular segment is less than the density of the support units of the anterior and posterior annular segments.

[0019] According to one embodiment, the support skeleton is preferably made of a metal shape memory alloy material, such as nickel-titanium alloy; the support skeleton is composed of dense support units, and adjacent support units are interwoven at the atrial position, which allows the atrial portion of the braided ring to fully cover and fit tightly against every position of the autologous valve annulus, avoiding the gaps between adjacent support units being too large, which would prevent the gaps from fitting tightly against the autologous valve annulus.

[0020] According to one embodiment, the close-fitting structure is configured in an arc shape, and when the valve prosthesis is implanted, the close-fitting structure covers or adheres to the autologous valve annulus.

[0021] According to one embodiment, the ventricular portion includes an edge with a notch, the edge being fixedly connected to the valve suture segment, the notch of the edge being located on the valve suture segment directly opposite the active area of ​​the artificial leaflet; when the valve prosthesis is in the open state, blood located between the artificial leaflet and the ventricular portion flows out through the notch of the edge.

[0022] According to one embodiment, the artificial leaflet is fixed within the valve suture section by a flexible thread, and the artificial leaflet includes a fixed part and a moving part; and the contour formed at the junction of the fixed part and the moving part is similar to the contour of the edge notch.

[0023] According to one embodiment, the moving part and the notch at the edge are positioned opposite each other, and the ventricular portion and the moving part do not overlap on the cross-section of the central axis of the valve suture segment. This allows blood between the artificial leaflet and the ventricular portion to flow out through the notch at the edge when the valve prosthesis is in the open state. The advantage of this design is that when the moving part of the artificial leaflet is open, the blood around the artificial leaflet is squeezed towards the ventricular wall by the artificial leaflet, while the edge of the ventricular segment does not obstruct the blood flow, allowing the blood to flow out quickly from the notch at the edge, thus avoiding blood stasis and thrombosis after long-term implantation.

[0024] According to one embodiment, the edge of the ventricular portion is provided with three continuous notches, the edge of the ventricular portion is generally wavy, and the notches of the edge are directly opposite the moving part of the artificial leaflet. The advantage of this design is that when the artificial leaflet is in the open state (i.e., moving from the center of the valve suture segment to the inner surface of the valve suture segment), the blood around the outer surface of the artificial leaflet can flow out through the notches of the edge, avoiding blood from staying between the outer periphery of the artificial leaflet and the braided ring, forming eddies, which could lead to thrombosis over time.

[0025] Compared with the prior art, the advantages of this application are:

[0026] 1. During the opening and closing of an autologous valve, the central region of the valve leaflet exhibits the greatest variation (stroke) before and after opening and closing, especially with significant axial height fluctuations. This results in the highest blood regurgitation pressure in the annulus portion corresponding to the central region of the valve leaflet. Existing leak-proof rings cannot maintain a tight fit with the autologous valve annulus tissue. When the autologous valve closes, the annulus portion corresponding to the central region of the valve leaflet experiences the greatest undulation, increasing the gap between the leak-proof ring and the autologous valve annulus, leading to the most severe blood regurgitation. In one embodiment of this invention, both the anterior and posterior annulus segments are provided with a close-fitting structure. This close-fitting structure allows the braided ring to fit snugly against the autologous valve annulus, and the outer periphery of the braided ring can abut against the atrial wall, ensuring the braided ring... The anterior and posterior valve annulus segments are designed to fit snugly against the heart tissue, preventing blood backflow. Both segments gradually press downwards from both ends towards the center, ensuring that the point of maximum downward pressure on the annulus segments corresponds precisely to the central region of the valve leaflet. This ensures that when the valve annulus (especially the central region) expands and undulates during opening and closing, the edge height of the central region of the anterior and posterior valve annulus segments remains lower than the edge height of the ends of the anterior and posterior valve annulus segments. This allows the atrial portion of the braided annulus to completely cover and closely adhere to the valve annulus and atrial tissue, adapting to changes in the valve annulus and effectively preventing paravalvular leakage.

[0027] 2. In a different embodiment of the present invention, the rigidity of the septal annulus segment is less than that of the anterior annulus segment and the posterior annulus segment. The septal annulus segment is located close to the ventricular septum tissue. Since the fixation device is fixed to the ventricular septum by the anchor, the rigidity of the septal annulus segment is relatively small, which avoids damage to the tissue at the septal annulus after implantation and also allows the septal annulus segment to fit more closely to the tissue at the septal annulus.

[0028] 3. Unlike the prior art, in one embodiment of the present invention, the ventricular segment and the moving part do not overlap on the cross section of the central axis of the valve suture segment. The advantage of this design is that when the moving part of the artificial valve leaflet is opened, the blood around the artificial valve leaflet is squeezed towards the ventricular wall by the artificial valve leaflet, while the edge of the ventricular segment does not obstruct the blood flow, allowing the blood to flow out quickly from the edge gap, avoiding blood stasis and thrombosis after long-term implantation.

[0029] 4. In the prior art, to avoid paravalvular leakage, the anti-leakage ring needs to extend from the atrial annulus to the autologous annulus or ventricle. This effectively prevents blood from the atrium or ventricle from seeping into the gap between the valve prosthesis and the autologous annulus when the valve closes, causing severe paravalvular leakage. However, this creates a gap between the artificial leaflet and the anti-leakage ring, preventing timely drainage of this blood when the artificial leaflet opens, which can lead to thrombosis over time. In one embodiment of the present invention, the braided ring has an edge in the ventricular segment with a notch, and this notch faces the moving part of the artificial leaflet. This allows blood between the ventricular segment of the braided ring and the artificial leaflet to drain quickly through the notch when the artificial leaflet opens, preventing blood pooling. It also prevents blood from forming eddies between the ventricular segment and the artificial leaflet, which could lead to severe thrombosis over time.

[0030] 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

[0031] The above-described features and advantages of these embodiments, as well as other features and advantages, and the ways in which they are implemented, 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:

[0032] Figures 1a-1c This is a schematic diagram of the overall structure of the valve prosthesis of the present invention.

[0033] Figures 2a-2e This is a schematic diagram of the atrium structure of the present invention.

[0034] Figures 3a-3dThis is a schematic diagram of the structure of the artificial valve leaflet and ventricular section of the present invention.

[0035] The parts referred to by the numbers in the attached diagram are as follows: 1-Stent, 11-Braided ring, 111-Ventricular section, 1111-Edge, 1112-Notch, 112-Valve annulus section, 113-Atrial section, 1131-Septal valve annulus segment, 1132-Anterior valve annulus segment, 1133-Posterior valve annulus segment, 1134-Close-fitting structure, 114-Supporting skeleton, 1141-Supporting unit, 115-Fabric layer, 12-Valve suture segment, 13-Fixing device, 14-Anchoring element, 2-Artificial leaflet, 21-Fixing part, 22-Movement part. Detailed Implementation

[0036] The present application will now be described in further detail with reference to the accompanying drawings and embodiments. Specific Implementation

[0037] 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.

[0038] 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.

[0039] 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.

[0040] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0041] In this application, "proximal" refers to the end closest to the apex of the heart, and "distal" refers to the end furthest from the apex of the heart. Example 1

[0042] The tricuspid valve of the human heart has anterior leaflet, posterior leaflet, and diaphragmatic leaflet. The anterior leaflet, posterior leaflet, and diaphragmatic leaflet are in a closed state when the heart contracts. When any one of the anterior leaflet, posterior leaflet, or diaphragmatic leaflet fails to close properly, valvular regurgitation occurs.

[0043] When an autologous valve opens and closes, the central region of the valve leaflet undergoes the greatest change (motion range) before and after opening and closing, resulting in the greatest pressure of blood backflow in the valve annulus corresponding to the central region of the autologous valve leaflet.

[0044] According to one example, a valve prosthesis for treating tricuspid valve disease includes a stent 1 and an artificial leaflet 2, wherein the stent 1 includes a braided ring 11, a valve suture segment 12, a fixation device 13, and an anchor 14, as shown. Figure 1a and 1b As shown, one end of the fixation device 13 is connected to the valve suture section 12, and the other end of the fixation device 13 is fixed to the interventricular septum tissue through the anchor 14. The braided ring 11 is connected to the valve suture section 12, and the artificial valve leaflet 2 is fixed inside the valve suture section 12. The cross-sectional area of ​​the braided ring 11 is larger than that of the autologous valve annulus. The braided ring 11 includes a ventricular portion 111, a valve annulus portion 112, and an atrial portion 113. The atrial portion 113 includes a septal valve annulus segment 1131, an anterior valve annulus segment 1132, and a posterior valve annulus segment 1133. Both the anterior valve annulus segment 1132 and the posterior valve annulus segment 1133 are provided with a close-fitting structure 1134. The close-fitting structure 1134 causes the edges 1111 of the anterior valve annulus segment 1132 and the edges 1111 of the posterior valve annulus segment 1133 to be pressed downwards towards the proximal end. The close-fitting structure 1134 allows the braided ring 11 to conform to the autologous valve annulus. Figure 2a and 2b As shown, the outer peripheral edge 1111 of the atrial portion 113 can abut against the atrial wall, allowing the outer peripheral edge 1111 of the atrial portion 113 to fit tightly against the cardiac tissue, such as... Figure 2c As shown; and, after the front lobe segment 1132 and the rear lobe segment 1133 of the braided loop 11 are laid out flat, as shown... Figure 1cAs shown; the edges 1111 of the anterior lobe annular segment 1132 and the posterior lobe annular segment 1133 are wavy, with the edges 1111 of the middle region of the anterior lobe annular segment 1132 and the posterior lobe annular segment 1133 at troughs, and the edges 1111 of the ends of the anterior lobe annular segment 1132 and the posterior lobe annular segment 1133 at crests; both the anterior lobe annular segment 1132 and the posterior lobe annular segment 1133 gradually press downwards from both ends towards the middle, causing the anterior lobe annular segment... The position where the downward pressure of the anterior annular segment 1132 and the posterior annular segment 1133 is the largest is exactly in the annular segment corresponding to the middle region of the autologous valve leaflet. When the valve prosthesis is installed in place, when the autologous valve opens and closes, the height of the edge 1111 of the middle region of the anterior annular segment 1132 and the height of the edge 1111 of the middle region of the posterior annular segment 1122 are always lower than the height of the edge of the end of the anterior annular segment 1132 and the edge of the end of the posterior annular segment 1133, and the edge of the atrial portion 113 is always in close contact with the autologous valve annulus or atrial tissue.

[0045] In this embodiment, the braided ring 11 includes a supporting skeleton 114 and a fabric layer 115, such as Figure 2e As shown, the support frame 114 is composed of multiple support units 1141, and during the opening and closing process of the autologous valve, the autologous valve ring undulates in the axial direction, and the edge of the braided ring 11 is always in close contact with the atrial tissue.

[0046] In this embodiment, after the valve prosthesis is implanted, the close-fitting structure 1134 fits the autologous valve annulus, and the edge 1111 of the atrial portion 113 abuts against the patient's atrial wall; the cross-sectional area of ​​the braided ring 11 is larger than the cross-sectional area of ​​the autologous valve annulus, and the close-fitting structure 1134 fits the valve annulus. At the same time, the edge 1111 of the atrial portion 113 abuts against the patient's atrial wall, which can better ensure the sealing of the braided ring 11.

[0047] In this embodiment, the cross-sectional area of ​​the septal annular segment 1131 is smaller than the cross-sectional area of ​​the anterior annular segment 1132 and the posterior annular segment 1133, such as... Figure 2d As shown; the fixing device 13 is fixed to the interventricular septum by the anchor 14. The position of the interventricular septum is close to the septal annulus segment 1131. In order to ensure the stability of the valve sewing segment 12, the valve sewing segment 12 is placed close to the septal annulus segment 1131.

[0048] In this embodiment, the rigidity of the septal annular segment 1131 is less than that of the anterior annular segment 1132 and the posterior annular segment 1133. The septal annular segment 1131 is located close to the ventricular septum tissue. Since the fixation device 13 is fixed to the ventricular septum by the anchor 14, the rigidity of the septal annular segment 1131 is relatively small, which avoids damage to the tissue at the septal annulus after implantation and also allows the septal annular segment 1131 to fit the tissue at the septal annulus more closely.

[0049] In this embodiment, the density of the support unit 1141 of the septal annular segment 1131 is less than the density of the support unit 1141 of the anterior annular segment 1132 and the posterior annular segment 1133.

[0050] In this embodiment, the support frame 114 is preferably made of a metal shape memory alloy material, such as nickel-titanium alloy; the support frame 114 is composed of dense support units 1141, and adjacent support units 1141 are interwoven at the atrial portion 113, which allows the atrial portion 113 of the braided ring 11 to fully cover and fit tightly against every part of the autologous valve annulus, avoiding the gaps between adjacent support units 1141 being too large, which would prevent the gaps from fitting tightly against the autologous valve annulus.

[0051] In this embodiment, the close-fitting structure 1134 is configured in an arc shape, and when the valve prosthesis is implanted, the close-fitting structure 1134 covers or adheres to the autologous valve annulus.

[0052] In this embodiment, the ventricular portion 111 includes an edge 1111 with a notch 1112, such as... Figure 2b As shown, the edge 1111 is fixedly connected to the valve suture section 12, and the notch 1112 of the edge 1111 is located on the valve suture section 12 directly opposite the active area of ​​the artificial leaflet 2; when the valve prosthesis is in the open state, the blood located between the artificial leaflet 2 and the ventricular portion 111 flows out through the notch 1112 of the edge 1111.

[0053] In this embodiment, the artificial leaflet 2 is fixed within the valve suture section 12 by a flexible thread. The artificial leaflet 2 includes a fixing part 21 and a moving part 22, such as... Figures 3a-3c As shown; and the contour formed at the junction of the fixed part 21 and the moving part 22 is similar to the contour of the notch 1112 at the edge 1111.

[0054] In this embodiment, the moving part 22 is positioned opposite to the notch 1112 of the edge 1111, and the ventricular part 111 and the moving part 22 do not overlap on the cross section of the central axis of the valve suture segment 12. This allows blood between the artificial leaflet 2 and the ventricular part 111 to flow out through the notch 1112 of the edge 1111 when the valve prosthesis is in the open state. The advantage of this design is that when the moving part 22 of the artificial leaflet 2 is opened, the blood around the artificial leaflet 2 is squeezed towards the ventricular wall by the artificial leaflet 2, while the edge 1111 of the ventricular segment does not obstruct the blood flow, allowing the blood to flow out quickly from the notch 1112 of the edge 1111, thus avoiding blood stasis and thrombosis after long-term implantation.

[0055] In this embodiment, the edge 1111 of the ventricular portion 111 is provided with three consecutive notches 1112, such as... Figure 3d As shown, the edge 1111 of the ventricular portion 111 is generally wavy, and the notch 1112 of the edge 1111 is directly opposite the moving part 22 of the artificial leaflet 2. The advantage of this design is that when the artificial leaflet 2 is in the open state (i.e., moving from the center of the valve suture section 12 to the inner surface of the valve suture section 12), the blood around the outer surface of the artificial leaflet 2 can flow out through the notch 1112 of the edge 1111, avoiding the blood from staying between the outer periphery of the artificial leaflet 2 and the braided ring 11 and forming eddies, which could lead to thrombosis over time.

[0056] The above content is only a preferred embodiment of this application. For those skilled in the art, there will be changes in the specific implementation and application scope based on the ideas of this application. The content of this specification should not be construed as a limitation of this application.

Claims

1. A valve prosthesis for treating tricuspid valve disease, comprising a stent and an artificial leaflet, the stent comprising a braided ring and a valve suture segment, the braided ring being connected to the valve suture segment, the artificial leaflet being fixed within the valve suture segment, the cross-sectional area of ​​the braided ring being larger than the cross-sectional area of ​​an autologous valve annulus, the braided ring comprising a ventricular portion, a valve annulus portion, and an atrial portion, characterized in that: The atrial portion includes a septal valve annulus, an anterior valve annulus, and a posterior valve annulus. Both the anterior and posterior valve annulus segments have a close-fitting structure that presses the edges of the anterior and posterior valve annulus segments downwards towards the ventricle. When the braided annulus segments are laid flat, their edges exhibit a wavy shape, with the edges of the middle regions of the anterior and posterior valve annulus segments at troughs and the edges of the ends of the anterior and posterior valve annulus segments at peaks. When the valve prosthesis is in place and the autologous valve opens and closes, the height of the edge of the middle region of the anterior valve annulus segment is always lower than the height of the edge of the end of the anterior valve annulus segment, and the height of the edge of the middle region of the posterior valve annulus segment is always lower than the height of the edge of the end of the posterior valve annulus segment. Furthermore, the edges of the atrial portion are always in close contact with the autologous valve annulus or atrial tissue.

2. The valve prosthesis for treating tricuspid valve according to claim 1, characterized in that: The braided ring includes a support skeleton and a fabric layer. The support skeleton is composed of multiple support units. Adjacent support units are interwoven at the atrial position. During the opening and closing of the autologous valve, the autologous valve ring undulates axially, and the edge portion of the braided ring is always in close contact with the atrial tissue.

3. A valve prosthesis for treating tricuspid valve according to claim 1, characterized in that: The valve prosthesis also includes a fixation device and an anchor. One end of the fixation device is connected to the valve suture section, and the other end of the fixation device is fixed to the interventricular septum tissue by the anchor.

4. A valve prosthesis for treating tricuspid valve according to claim 1, characterized in that: The cross-sectional area of ​​each septal annular segment is smaller than the cross-sectional area of ​​the anterior annular segment and the posterior annular segment.

5. A valve prosthesis for treating tricuspid valve according to claim 4, characterized in that: The rigidity of each septal annular segment is less than that of the anterior annular segment and the posterior annular segment.

6. A valve prosthesis for treating tricuspid valve according to claim 4, characterized in that: The density of the support unit of the septal annular segment is less than the density of the support unit of the anterior and posterior annular segments.

7. A valve prosthesis for treating tricuspid valve according to claim 1, characterized in that: The fitting structure is designed in an arc shape, and after the valve prosthesis is implanted, the fitting structure covers or adheres to the autologous valve annulus.

8. A valve prosthesis for treating tricuspid valve according to claim 1, characterized in that: The ventricular portion includes an edge with a notch, the edge being fixedly connected to the valve suture section, the notch of the edge being located on the valve suture section directly opposite the active area of ​​the artificial valve leaflet; when the valve prosthesis is in the open state, blood located between the artificial valve leaflet and the ventricular portion flows out through the notch of the edge.

9. A valve prosthesis for treating tricuspid valve according to claim 8, characterized in that: The artificial leaflet is fixed within the valve suture section by a flexible thread. The artificial leaflet includes a fixed part and a moving part. Furthermore, the contour formed at the junction of the fixed part and the moving part is similar to the contour of the edge notch.

10. A valve prosthesis for treating tricuspid valve according to claim 9, characterized in that: The moving part is positioned directly opposite the notch on the edge, and in the cross-section of the central axis of the valve suture section, the ventricular portion and the moving part do not overlap, so that when the valve prosthesis is in the open state, the blood located between the artificial valve leaflet and the ventricular portion flows out through the notch on the edge.

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