Integrated heart valve stent with inflow end with reinforced supporting performance

Abstract

The invention discloses an integrated heart valve stent with the supporting performance of an inflow end enhanced, and relates to heart valve stents. The integrated heart valve stent with the supporting performance of the inflow end enhanced comprises a main stent body, and the main stent body comprises an outflow end supporting rod, an inflow end supporting rod and a plurality of crossed supporting rods. The outflow end supporting rod is composed of a plurality of outflow end supporting rod sections, and the inflow end supporting rod is composed of a plurality of inflow end supporting rod sections. The main body support further comprises a plurality of inflow end reinforcing rods, and the inflow end reinforcing rods are arranged between the adjacent inflow end supporting rod sections. The main body support is further provided with a plurality of sets of positioning pieces used for being inserted into the sinus bases of the heart valves, and the positioning pieces are connected with the cross supporting rods. Through the arrangement, the supporting capacity of the inflow end of the heart valve stent is improved, so that the friction anchoring force between the valve and the annulus tissue is enhanced, and the displacement risk of the heart valve stent is reduced.

Description

Technical Field

[0001] This invention relates to the field of cardiac valve stents, and in particular to an integrated cardiac valve stent with enhanced inflow-end support. Background Technology

[0002] Valvular heart disease is a type of structural heart disease. Valve abnormalities, such as stenosis or insufficiency, often impede normal blood flow, leading to functional damage to the heart. In terms of the location of valvular lesions, the mitral and aortic valves bear the greatest pressure and are most susceptible to involvement; therefore, these two valves have a higher incidence of disease. Currently, there are approximately 4.1 million patients in China alone with aortic regurgitation (AR)-related disease. Among them, symptomatic severe patients (approximately 15%-20%) constitute the main population requiring treatment, with roughly 800,000 patients needing related treatment. Valve replacement surgery is an extremely effective treatment option.

[0003] Currently, the main methods for artificial heart valve replacement are traditional open-heart surgery and transcatheter interventional surgery. Surgical valve replacement is the most mature treatment method. However, due to the need for open-heart surgery and cardiopulmonary bypass, 30% of patients are forced to forgo or cannot undergo surgical treatment due to various reasons such as advanced age, poor left ventricular function, or serious comorbidities. Interventional valve replacement has become an alternative. Transcatheter interventional therapy, which has developed in recent years, has advantages such as being minimally invasive, low-risk, and allowing for rapid recovery.

[0004] After a heart valve is implanted in the human body, it continuously opens and closes under the reciprocating impact of blood flow. When the valve opens, it is subjected to the impact force of blood flow towards the aorta; when the valve closes, it is subjected to the impact force towards the ventricles. Existing valves have positioning components that prevent displacement towards the ventricles when the valve closes. However, when the valve opens, because its anchoring force comes solely from the friction between the inlet end of the heart valve stent and the valve annulus tissue, the valve can easily shift towards the aorta. Therefore, it is necessary to improve the support performance of the inlet end of the heart valve stent to enhance the frictional anchoring force between the valve and the valve annulus tissue, thereby reducing the risk of heart valve stent displacement.

[0005] In summary, the present invention urgently needs a device that can improve the support capacity of the inflow end of a heart valve stent to enhance the frictional anchoring force between the valve and the annulus tissue, thereby reducing the risk of heart valve stent displacement. Summary of the Invention

[0006] To address the aforementioned problems, the present invention provides an integrated cardiac valve stent with enhanced inflow support, which strengthens the support capacity of the inflow end of the cardiac valve.

[0007] This invention provides an integrated cardiac valve stent with enhanced inflow-end support, comprising a main stent, which includes an outflow-end support rod, an inflow-end support rod, and several cross support rods. The outflow-end support rod is located at the top of the main stent, the inflow-end support rod is located at the bottom of the main stent, and the cross support rods are located in the middle of the main stent, between the outflow-end and inflow-end support rods. Each outflow-end support rod is composed of several outflow-end support rod segments, and each inflow-end support rod is composed of several inflow-end support rod segments. A first grid is formed between corresponding outflow-end support rod segments and cross support rods, a second grid is formed between corresponding inflow-end support rod segments and cross support rods, and a third grid is formed between adjacent cross support rods. The main stent also includes several inflow-end reinforcing rods, which are positioned between adjacent inflow-end support rod segments and form a fourth grid with adjacent inflow-end support rod segments. The main stent also has multiple sets of positioning elements for insertion into the sinus base of the cardiac valve, and these positioning elements are connected to the cross support rods.

[0008] In one specific embodiment, the inflow end reinforcing rods are spaced apart between adjacent inflow end support rod segments and form a third grid with the adjacent inflow end support rod segments.

[0009] In one specific embodiment, both the outflow end support rod and the inflow end support rod are wavy in shape; the inflow end support rod segment, the outflow end support rod segment, and the reinforcing rod are all arrow-shaped.

[0010] In one specific embodiment, the positioning element includes a left positioning rod and a right positioning rod. The fixed ends of the left and right positioning rods are both connected to the cross support rods. The free ends of the left and right positioning rods in the same group are detachably connected.

[0011] In some specific embodiments, the following technical features are also included: a) a left connecting hole is provided on the free end of the left positioning rod, and a right connecting hole is provided on the free end of the right positioning rod. When the free ends of the left and right positioning rods are connected, the connecting rope is wound and passed through the left and right connecting holes; b) a groove is provided on the free end of the left positioning rod, and a protrusion is provided on the free end of the right positioning rod. When the free ends of the left and right positioning rods are connected, the protrusion is located in the groove.

[0012] In one specific embodiment, the left positioning rod includes a left positioning rod body and a left outwardly flared bottom. The left outwardly flared bottom is located on the free end of the left positioning rod body, and the width of the left outwardly flared bottom is greater than the width of the left positioning rod body. The right positioning rod includes a right positioning rod body and a right outwardly flared bottom. The right outwardly flared bottom is located on the free end of the right positioning rod body, and the width of the right outwardly flared bottom is greater than the width of the right positioning rod body.

[0013] In some specific embodiments, anchoring elements are provided on the inflow end support rod segment. Alternatively, anchoring elements are provided at intervals on the inflow end support rod segment.

[0014] In one specific embodiment, the positioning element is asymmetrical in shape, wherein the left or right positioning rod is curved.

[0015] In some specific embodiments, the outflow end support rod is provided with several retaining rings. And / or, the main body support is provided with barbs.

[0016] In some specific embodiments, the main support and / or positioning element is provided with a number of developing elements.

[0017] The integrated cardiac valve stent with enhanced inflow-end support provided by this invention has the following beneficial effects:

[0018] 1. The heart valve stent provided by the present invention can improve the support capacity of the inflow end of the heart valve stent, thereby enhancing the frictional anchoring force between the valve and the valve annulus tissue, and thus reducing the risk of heart stent displacement.

[0019] 2. The inflow end support rod segment and the outflow end support rod segment designed in this invention are arrow-shaped, and the arrow shape of the inflow end support rod segment is larger than that of the outflow end support rod segment. This arrangement can further strengthen the support force at the inflow end of the main support, making the main support more stable.

[0020] 3. The inflow end reinforcing rod designed in this invention is located between adjacent inflow end support rod sections, and the shape of the inflow end reinforcing rod is arrow-shaped. Preferably, the arrow shape of the inflow end reinforcing rod is smaller than the arrow shape of the inflow end support rod section. This arrangement can strengthen the support force of the inflow end of the main support while minimizing the total weight of the main support.

[0021] 4. The positioning element designed in this invention enables the heart valve stent of this invention to retain the part overlapping with the positioning element (i.e., the cross support rod) when it is cut, thus preventing paravalvular leakage. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the overall structure of the present invention. Figure 1 .

[0023] Figure 2 This is a schematic diagram of the overall structure of the present invention. Figure 2 .

[0024] Figure 3 This is a schematic diagram of the planar cutting of the present invention.

[0025] Figure 4 This is a schematic diagram of the "expanded" state of the present invention.

[0026] Figure 5 This is a schematic diagram of the "pressed-grip" state of the present invention.

[0027] Figure Labels

[0028] Main support 1

[0029] Outflow end support rod 11

[0030] Outflow end support rod section 11.1

[0031] Inflow end support rod 12

[0032] Inflow end support segment 12.1

[0033] Cross support rod 13

[0034] Reinforcing bar 14

[0035] Positioning component 2

[0036] Left positioning rod 21

[0037] Left positioning rod body 21.1

[0038] Left outward expansion at the bottom 21.2

[0039] Left connecting hole 21.3

[0040] Groove 21.4

[0041] Right positioning rod 22

[0042] Right positioning rod body 22.1

[0043] Right outward expansion at the bottom 22.2

[0044] Right connecting hole 22.3

[0045] Protrusion 22.4

[0046] Developed Part 3

[0047] 4 barbs

[0048] Anchor 5

[0049] 6-ring retainer

[0050] First grid 91

[0051] Second grid 92

[0052] Third grid 93

[0053] Fourth grid 94 Detailed Implementation

[0054] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. In the description of the present invention, it should be noted that the terms "left side", "right side", "upper side", "lower side", "above", "below", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention. In addition, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0055] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0056] Furthermore, in the description of this invention, unless otherwise stated, "a number" means two or more.

[0057] Before detailing the embodiments, some explanations are provided: the artificial aortic valve should be housed within the main support 1 of this invention, and the opening direction of the artificial aortic valve should be consistent with the blood flow direction, such as... Figure 4 As shown, the blood flows from bottom to top. Specifically, both native and artificial aortic valves have two states: a "closed state" and an "open state." When blood flows past the aortic valve, it impacts the valve, causing it to change from a "closed state" to an "open state." After the blood has passed, the valve changes back to a "closed state." Furthermore, to allow the invention to be delivered to the designated location of the aortic valve via the aorta, the device is in a "gripping" state during catheter transport. The overall radius of the device is small, and the various structures are closely arranged. Figure 5 As shown. When this device reaches the designated position, the conduit controls the device to expand outwards and enter the "expansion" state, as... Figure 4 As shown.

[0058] The present invention discloses an integrated cardiac valve stent with enhanced inflow support, which is a stent for mounting an artificial aortic valve. It can mount the artificial aortic valve and fix it in the position of the native aortic valve, thereby replacing the native aortic valve. In use, the positioning element 2 is first inserted into the sinus base of the native aortic valve. At this time, each native aortic valve should be located between the positioning element 2 and the main stent 1. During this step, the present invention should be positioned as follows: Figure 5 The state is shown. Next, the main stent 1 is released, causing it to expand and compress the native aortic valve, rendering it inoperable. In this step, the invention achieves the following: Figure 5 The state shown is as follows Figure 4 The state transitions shown, and ultimately as follows Figure 4 The position shown is fixed in place of the original heart valve. This completes the replacement of the original aortic valve with an artificial aortic valve, enabling the artificial aortic valve to "open" and "close."

[0059] This application provides an integrated cardiac valve stent with enhanced inflow-end support, see reference. Figure 1 The present invention relates to a cardiac valve stent comprising a main stent 1, which includes an outflow support rod 11, an inflow support rod 12, and a plurality of cross support rods 13. The outflow support rod 11 is located at the top of the main stent 1, the inflow support rod 12 is located at the bottom of the main stent 1, and the cross support rods 13 are located in the middle of the main stent 1, between the outflow support rod 11 and the inflow support rod 12. Further, the outflow support rod 11, the inflow support rod 12, and the plurality of cross support rods 13 are integrally formed. (Continue reading) Figure 1 , Figure 1 a and Figure 1 c. The outflow end support rod 11 is composed of several outflow end support rod segments 11.1, and the inflow end support rod 12 is composed of several inflow end support rod segments 12.1. In a specific embodiment, as... Figure 1 , Figure 1 a and Figure 1 As shown in Figure c, both the outflow end support rod segment 11.1 and the inflow end support rod segment 12.1 are arrow-shaped. Correspondingly, the outflow end support rod 11, integrally formed from several arrow-shaped outflow end support rod segments 11.1, is wavy, and the inflow end support rod 12, integrally formed from several arrow-shaped inflow end support rod segments 12.1, is also wavy. In a preferred embodiment, the arrow shape of the inflow end support rod segment 12.1 is larger than that of the outflow end support rod segment 11.1; that is, the inflow end support rod segment 12.1 is a large arrow, and the outflow end support rod segment 11.1 is a small arrow. This arrangement can further strengthen the support force at the inflow end of the main support 1, making the main support 1 more stable. (Continue reading...) Figure 1 and Figure 1b. A first grid 91 is formed between the corresponding inflow end support rod segment 11.1 and the cross support rod 13, a second grid 92 is formed between the corresponding inflow end support rod segment 12.1 and the cross support rod 13, and a third grid 93 is formed between adjacent cross support rods 13. The arrangement of the first grid 91, the second grid 92 and the third grid 93 can minimize the height of the support while ensuring the support force.

[0060] Continue reading Figure 1 The main support 1 also includes several inflow end reinforcing rods 14, which are disposed between adjacent inflow end support rod segments 11.1 and form a fourth grid 94 between adjacent inflow end support rod segments 11.1. In a specific embodiment, see [reference needed]. Figure 1 The inflow end reinforcing rod 14 is arrow-shaped. Preferably, the arrow angle of the inflow end reinforcing rod 14 is equal to the arrow angle of the inflow end support rod segment 12.1, and the length of the inflow end reinforcing rod 14 is equal to half the length of the inflow end support rod segment 12.1. Further, the arrow angles of the inflow end reinforcing rod 14 and the inflow end support rod segment 12.1 are between 45° and 90°. This arrangement ensures that while maximizing the support force at the inflow end, its compression and rebound performance is also guaranteed. In another specific embodiment, such as... Figure 2 As shown, the inflow end reinforcing rods 14 are spaced apart between adjacent inflow end support rod segments 11.1 and form a third grid 14.1 with the adjacent inflow end support rod segments 11.1. This arrangement can maintain a certain support force at the inflow end of the main support 1 while further reducing the compression volume of the main support 1 and improving the compression capacity.

[0061] Continue reading Figure 1 The main support 1 is also equipped with multiple sets of positioning elements 2 for insertion into the sinus base of the heart valves. The positioning elements 2 are connected to the cross support rod 13. The number of positioning elements 2 matches the number of heart valves in the patient. Most people have three heart valves, so the number of positioning elements 2 is also three. However, a small percentage of people only have two heart valves, so for this group, the number of positioning elements 2 needs to be adjusted to two. Furthermore, in some specific embodiments, for example: Figure 1 As shown, the outflow end support rod 11 is provided with several fixing rings 6. Each fixing ring 6 provides an additional annular space for connection to a delivery device for delivering a heart valve stent. For example: Figure 2 As shown, the main support 1 and / or positioning component 2 are equipped with several developing elements 3, which are used to enhance the imaging effect. For example: Figure 2 As shown, the positioning element 2 has an asymmetrical shape, wherein the left positioning rod 21 or the right positioning rod 22 is curved, and the curvature can further enhance the imaging effect. For example: Figure 3As shown, the main support 1 is provided with barbs 4, which can be inserted into the original heart valve to enhance the stability of the main support 1.

[0062] Before describing the positioning element 2, let's briefly explain the manufacturing process of the heart valve stent: Although the heart valve stent is in an "expanded" state during use, that is, annular (such as... Figure 4 (As shown), however, current heart valve stent manufacturing involves cutting and carving on metal tubes, meaning the laser cutting pattern for heart valve stents is planar (see reference). Figures 1-3 (As shown in the diagram), the main support is formed by cutting around the metal tube along this plane. Therefore, this processing method means that if the positioning element 2 remains connected, the overlapping portion (i.e., the cross support rod 13) must be hollowed out during the plane processing to ensure that the positioning element 2 can be cut out. This large-area hollowing increases the risk of potential paravalvular leakage and the risk of the native leaflet invading the artificial leaflet. Therefore, this invention designs a positioning element 2 to solve the above problems. See also... Figure 3 The positioning component 2 includes a left positioning rod 21 and a right positioning rod 22. The fixed ends of both the left and right positioning rods 21 and 22 are connected to the cross support rod 13. The free ends of the left and right positioning rods 21 and 22 are detachably connected within the same group. Furthermore, during cutting, such as... Figure 3 As shown, the left positioning rod 21 and the right positioning rod 22 can be located in the third grid 93. After cutting, as... Figure 1 or Figure 4 As shown, the left positioning rod 21 and the right positioning rod 22 are then connected. This configuration allows the cardiac valve stent of the present invention to retain the portion overlapping with the positioning element 2 (i.e., the cross support rod 13) during cutting, reducing the risk of potential paravalvular leakage and the risk of the native leaflet invading the artificial leaflet.

[0063] Furthermore, two connection schemes for the left positioning rod 21 and the right positioning rod 22 are provided. The first scheme, as shown... Figure 1 d and Figure 4 As shown, the free end of the left positioning rod 21 has a left connecting hole 21.3, and the free end of the right positioning rod 22 has a right connecting hole 22.3. When connecting the free ends of the left positioning rod 21 and right positioning rod 22, the connecting rope is passed through the left connecting hole 21.3 and the right connecting hole 22.3 respectively and knotted to complete the connection. The second method, as... Figure 1 As shown in Figure e, the free end of the left positioning rod 21 has a groove 21.4, and the free end of the right positioning rod 22 has a protrusion 22.4. The groove 21.4 and the protrusion 22.4 are matched. When the free end of the left positioning rod 21 is connected to the free end of the right positioning rod 22, the protrusion 22.4 is inserted into the groove 21.4 to complete the connection. Further details can be found in the reference section. Figure 3The left positioning rod 21 includes a left positioning rod body 21.1 and a left outwardly flared bottom 21.2. The left outwardly flared bottom 21.2 is located on the free end of the left positioning rod body 21.1, and the width of the left outwardly flared bottom 21.2 is greater than the width of the left positioning rod body 21.1. The right positioning rod 22 includes a right positioning rod body 22.1 and a right outwardly flared bottom 22.2. The right outwardly flared bottom 22.2 is located on the free end of the right positioning rod body 22.1, and the width of the right outwardly flared bottom 22.2 is greater than the width of the right positioning rod body 22.1. This configuration allows for greater design space between the left connecting hole 21.3 and the right connecting hole 22.3, or between the groove 21.4 and the protrusion 22.4, facilitating the connection between the left positioning rod 21 and the right positioning rod 22.

[0064] Furthermore, such as Figure 1 As shown, an anchoring element 5 is provided on the inflow end support rod segment 12.1. The anchoring element 5 can be inserted into the native heart valve to enhance the stability of the main stent 1. Or, as... Figure 2 As shown, anchoring elements 5 are provided at intervals on the inflow end support rod segment 12.1. The interval setting can minimize myocardial damage while maintaining a certain stability of the main support 1.

[0065] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and substitutions can be made without departing from the technical principles of the present invention, and these improvements and substitutions should also be considered within the scope of protection of the present invention.

Claims

1. An integrated cardiac valve stent with enhanced inflow-end support, characterized in that: The system includes a main support frame (1), which includes an outflow end support rod (11), an inflow end support rod (12), and several cross support rods (13). The outflow end support rod (11) is located at the top of the main support frame (1), the inflow end support rod (12) is located at the bottom of the main support frame (1), and the cross support rods (13) are located in the middle of the main support frame (1) and between the outflow end support rod (11) and the inflow end support rod (12). The outflow end support rod (11) is composed of several outflow end support rod segments (11.1), and the inflow end support rod (12) is composed of several inflow end support rod segments (12.1); a first grid (91) is formed between the corresponding outflow end support rod segment (11.1) and the cross support rod (13), a second grid (92) is formed between the corresponding inflow end support rod segment (12.1) and the cross support rod (13), and a third grid (93) is formed between adjacent cross support rods (13); The main support (1) also includes several inflow end reinforcing rods (14), which are disposed between adjacent inflow end support rod segments (11.1) and form a fourth grid (94) between adjacent inflow end support rod segments (11.1); The main support (1) is also provided with multiple sets of positioning elements (2) for insertion into the sinus base of the heart valve, and the positioning elements (2) are connected to the cross support rod (13).

2. The integrated cardiac valve stent with enhanced inflow-end support according to claim 1, characterized in that: The inflow end reinforcing rod (14) is spaced apart between adjacent inflow end support rod segments (11.1) and forms a third grid (14.1) with the adjacent inflow end support rod segments (11.1).

3. The integrated cardiac valve stent with enhanced inflow-end support according to claim 2, characterized in that: The outflow end support rod (11) and the inflow end support rod (12) are both wavy in shape; the inflow end support rod segment (11.1), the outflow end support rod segment (12.1) and the reinforcing rod (14) are all arrow-shaped.

4. The integrated cardiac valve stent with enhanced inflow-end support according to claim 1, characterized in that: The positioning component (2) includes a left positioning rod (21) and a right positioning rod (22). The fixed ends of the left positioning rod (21) and the right positioning rod (22) are both connected to the cross support rod (13). The free ends of the left positioning rod (21) and the right positioning rod (22) in the same group are detachably connected.

5. The integrated cardiac valve stent with enhanced inflow-end support according to claim 3 or 4, characterized in that, It also includes any one of the following technical features: a) The free end of the left positioning rod (21) is provided with a left connecting hole (21.3), and the free end of the right positioning rod (22) is provided with a right connecting hole (22.3); when the free end of the left positioning rod (21) is connected to the free end of the right positioning rod (22), the connecting rope is wound and passed through the left connecting hole (21.3) and the right connecting hole (22.3); b) The free end of the left positioning rod (21) is provided with a groove (21.4) and the free end of the right positioning rod (22) is provided with a protrusion (22.4); when the free end of the left positioning rod (21) is connected to the free end of the right positioning rod (22), the protrusion (22.4) is provided in the groove (21.4).

6. The integrated cardiac valve stent with enhanced inflow-end support according to claim 3, characterized in that: The left positioning rod (21) includes a left positioning rod body (21.1) and a left outwardly expanding bottom (21.2). The left outwardly expanding bottom (21.2) is located on the free end of the left positioning rod body (21.1), and the width of the left outwardly expanding bottom (21.2) is greater than the width of the left positioning rod body (21.1). The right positioning rod (22) includes a right positioning rod body (22.1) and a right outwardly flared bottom (22.2). The right outwardly flared bottom (22.2) is located on the free end of the right positioning rod body (22.1), and the width of the right outwardly flared bottom (22.2) is greater than the width of the right positioning rod body (22.1).

7. The integrated cardiac valve stent with enhanced inflow-end support according to claim 1, characterized in that: An anchor (5) is provided on the inflow end support rod section (12.1); or, anchors (5) are provided at intervals on the inflow end support rod section (12.1).

8. The integrated cardiac valve stent with enhanced inflow support according to claim 1 or 2, characterized in that: The positioning element (2) is asymmetrical in shape, wherein the left positioning rod (21) or the right positioning rod (22) is curved.

9. The integrated cardiac valve stent with enhanced inflow support according to claim 1 or 2, characterized in that: The outflow end support rod (11) is provided with a plurality of fixing rings (6); and / or, the main body bracket (1) is provided with barbs (4).

10. The integrated cardiac valve stent with enhanced inflow-end support according to claim 1, characterized in that: The main support (1) and / or the positioning element (2) are provided with a plurality of developing elements (3).

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