Prosthetic valve assembly, implantation system and implantation method

Abstract

The application provides a prosthetic valve assembly and implant system, which is delivered and released to a heart via a delivery device to at least partially replace a native valve of the heart, wherein the native valve comprises a native valve annulus and native valve leaflets, the prosthetic valve assembly comprising: an anchor having a clamping portion for clamping at least a portion of the native valve leaflets; a prosthetic valve having: prosthetic valve leaflets; a support structure connected to the prosthetic valve leaflets for supporting the prosthetic valve leaflets; wherein the prosthetic valve cooperates with the anchor, the anchor and the prosthetic valve are structurally independent of each other, and the anchor and the prosthetic valve are in a compressed state during delivery and in an expanded state during release. The prosthetic valve assembly of the application can be delivered or released to the heart separately, so that a smaller diameter delivery system can be used for delivery.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to an artificial valve assembly, implantation system and implantation method. Background Technology

[0002] The mitral and tricuspid valves have complex structures, consisting of annulus, leaflets, chordae tendineae, and papillary muscles. Organic or functional changes in any of these components can lead to mitral or tricuspid regurgitation, meaning that the valves fail to close completely during cardiac systole, causing blood to flow backward into the left ventricle. Treatment for mitral and tricuspid regurgitation includes valve repair and replacement. Valve repair is a common first-line treatment, but valve replacement is the ultimate and fundamental solution.

[0003] Valve replacement can be performed surgically or via catheter intervention. For some patients with mitral or tricuspid regurgitation who are not suitable for surgery due to high-risk factors such as poor cardiac function, multiple comorbidities, and advanced age, they can receive treatment via catheter intervention. While various structural designs and delivery methods for transcatheter mitral and tricuspid valves have emerged in recent years, most remain in the research stage due to the following limiting factors: The mitral and tricuspid valves are structurally complex. Compared to the aortic valve, their overall structure is D-shaped with larger annular dimensions and less calcification, making it insufficient to provide adequate support for the artificial valve to fix it in place at the diseased mitral or tricuspid location. Anatomically, the left ventricular outflow tract is adjacent to the anterior leaflet of the mitral or tricuspid valve, and implantation of an artificial mitral or tricuspid valve may cause left ventricular outflow tract obstruction (LVOTO). The larger annular dimensions of the mitral or tricuspid valve necessitate a larger diameter stent for the artificial valve, requiring a larger leaflet area, which reduces leaflet fatigue resistance and increases the size of the delivery system, thereby increasing the risk of vascular complications.

[0004] Therefore, there is an urgent need for an artificial valve system that can reduce the size of the artificial valve delivery system, facilitate the replacement of the mitral or tricuspid valve, and prevent left ventricular outflow tract obstruction. Summary of the Invention

[0005] In view of the above problems, this application provides an artificial valve assembly to overcome or at least partially solve the above problems.

[0006] This application provides an artificial valve assembly, which is delivered and released to the heart via a delivery device to at least partially replace the heart's native valve. The native valve includes a native annulus and a native leaflet. The artificial valve assembly includes: an anchor with a clamping portion for clamping at least a portion of the native leaflet; an artificial valve having: an artificial leaflet; and a support structure connected to the artificial leaflet for supporting the artificial leaflet. The artificial valve cooperates with the anchor, and the anchor and the artificial valve are structurally independent. Both the anchor and the artificial valve are in a compressed state during delivery and in an expanded state during release. After the anchor and the artificial valve are delivered to the heart via the delivery device in a compressed state, the anchor is released first to allow the clamping portion to clamp at least a portion of the native leaflet, thereby positioning the anchor at the native leaflet. Then, the artificial valve is released to cooperate with the anchor.

[0007] Optionally, the effective diameter of the tip of the clamping part in the expanded state is smaller than the diameter of the original valve ring.

[0008] Optionally, the clamping part has an inner clamping member and an outer clamping member, which are used to clamp the inner and outer sides of the original leaflet respectively, thereby applying a tensile force to at least a portion of the clamped original leaflet so that the original leaflet forms a diameter close to that of the clamping part.

[0009] Optionally, the inner clamping member and the outer clamping member are elastic. In the expanded state, the inner clamping member and the outer clamping member together form a first structure that is approximately tubular. In the compressed state, the inner clamping member and the outer clamping member are radially compressed to form a second structure that is tubular or approximately bundle-shaped with a smaller diameter than the first structure.

[0010] Optionally, the inner clamping member and the outer clamping member are distributed at intervals along the circumference of the first structure, and the height of the inner clamping member is greater than the height of the outer clamping member. Adjacent inner clamping members and outer clamping members are connected by a first connector.

[0011] Optionally, the first connector is a U-shaped structure.

[0012] Optionally, the outer clamping member has a first head end and two first supports connected to each other, and the inner clamping member includes at least one of the following components: a first component having a second head end and two second supports connected to each other, the second head end extending radially outward from the two second supports along the first structure; and a second component having a third head end and two third supports connected to each other.

[0013] Optionally, the inner clamping member includes both the first component and the second component. Both the second end and the third end have an inverted U-shaped structure. The inverted U-shaped structure of the second end extends radially outward from the second support column along the first structure. The plane containing the inverted U-shaped structure of the second end forms an angle θ1 with the plane containing the second support column, where 0° < θ1 < 180°.

[0014] Optionally, the first pillar and the adjacent second and / or third pillar are provided with clamping reinforcements, each of which extends outward from the first, second and / or third pillar or is part of the first, second and / or third pillar, to enhance the clamping force between the inner clamping member and the outer clamping member.

[0015] Optionally, at least one of the first, second, and third pillars has a plurality of connected diagonal braces on its inner side to enhance the supporting force of the inner clamping member and the outer clamping member.

[0016] Optionally, the anchoring member also has at least one first fixing member, the inner clamping member includes a plurality of the second members, and the third end has an inverted U-shaped structure, with each of the first fixing members connected to two of the third ends respectively.

[0017] Optionally, the outer clamping member is provided with a control unit for connecting to the conveying device, and the control unit is controlled by the conveying device to drive the outer clamping member to open and close, so as to place at least a portion of the original leaflet between the inner clamping member and the outer clamping member.

[0018] Optionally, the outer surface of the second end or the first fastener is covered with a biocompatible fabric or membrane.

[0019] Optionally, in the expanded state, the support structure is approximately tubular in shape, and the diameter of the support structure is smaller than the diameter of the first structure, so that the support structure is placed inside the first structure; in the compressed state, the support structure is radially compressed to form a tubular or approximately bundled structure with a smaller diameter.

[0020] Optionally, the support structure has multiple elastic structural units that are evenly distributed along the circumference of the support structure. When subjected to circumferential force, each elastic structural unit can deform simultaneously along the major axis and the minor axis.

[0021] Optionally, the artificial valve also has an extension that extends from the surface of the elastic structural unit in a direction away from the surface, such that the circumferential diameter formed by the end of the extension is larger than the diameter of the clamping portion.

[0022] Optionally, the support structure is provided with at least one mating part that mates with the first member. The mating part extends radially outward along the support structure and is used to mate with the inner clamping member.

[0023] Optionally, the inner clamp is connected to the support structure so that the anchor and the artificial valve are in a connected state during delivery and release.

[0024] Optionally, the artificial valve also has a sealing element that covers the outer surface of the support structure to fill the gap between the support structure and the clamping part.

[0025] This application also provides an artificial valve implantation system, comprising: the aforementioned artificial valve assembly; and a delivery device including a sheath for receiving and delivering the anchor and the artificial valve to the heart.

[0026] Optionally, the anchor and the artificial valve are placed simultaneously in the sheath, with the anchor located at the distal end of the sheath and the artificial valve located at the proximal end of the sheath.

[0027] Optionally, the anchor and the artificial valve are interconnected.

[0028] Optionally, the conveying device further includes: a connector for connecting to the anchor; and a control member connected to the connector for controlling the clamping portion of the anchor via the connector, so that the clamping portion clamps at least a portion of the original leaflet.

[0029] This application also provides a method for implanting an artificial valve assembly into a native heart valve having a native annulus and a native leaflet, comprising: delivering an anchor and an artificial valve in a compressed state to the heart, wherein the artificial valve assembly includes: an anchor having a clamping portion for clamping at least a portion of the native leaflet; an artificial valve having: an artificial leaflet; a support structure connected to the artificial leaflet for supporting the artificial leaflet; the artificial valve cooperating with the anchor, the anchor and the artificial valve being structurally independent, and both the anchor and the artificial valve being in a compressed state during delivery and in an expanded state during release; first releasing the anchor so that the clamping portion clamps at least a portion of the native leaflet, thereby positioning the anchor at the native leaflet; then releasing the artificial valve so that the artificial valve cooperates with the anchor.

[0030] As can be seen from the above technical solutions, the anchor and the artificial valve in the artificial valve assembly of this application are independent structures, and therefore can be delivered or released to the heart separately. For example, the anchor can be released first, followed by the artificial valve, thereby allowing the use of a smaller diameter delivery system, reducing the difficulty of sheath bends, minimizing damage to blood vessels, and preventing the anterior leaflet from obstructing the left ventricular outflow tract. Furthermore, the diameter of the anchor is smaller than the diameter of the native valve annulus, facilitating the implantation of an appropriately sized artificial valve, thereby extending the lifespan of the artificial valve. Attached Figure Description

[0031] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings.

[0032] Figure 1 It is an anatomical diagram of the heart structure;

[0033] Figure 2 This is a schematic diagram of an embodiment of an artificial valve assembly anchor and an artificial valve in an expanded state.

[0034] Figure 3 This is a schematic diagram of an embodiment of an anchoring element of an artificial valve assembly in a compressed state according to this application;

[0035] Figure 4 This is a compressed schematic diagram of an embodiment of the support structure of an artificial valve assembly according to this application;

[0036] Figures 5A-5I These are schematic diagrams of different embodiments of an anchoring element according to this application;

[0037] Figure 5J This is a schematic diagram of the state in which the inner clamping part and the outer clamping part of the anchoring member of this application hold the heart valve.

[0038] Figure 6 This is a schematic diagram of an embodiment of an artificial valve according to this application;

[0039] Figures 7A-7B These are schematic diagrams of different embodiments of the extension of the support structure of an artificial valve according to this application;

[0040] Figures 8A-8D These are schematic diagrams of different embodiments of the mating part of the support structure of an artificial valve according to this application;

[0041] Figures 9A-9CThese are schematic diagrams of different embodiments of the elastic structural unit of the support structure of an artificial valve according to this application;

[0042] Figure 10 This is a schematic diagram of the interaction between an artificial valve and an anchoring element according to this application;

[0043] Figure 11 This is a top view of an embodiment of an artificial valve according to this application;

[0044] Figure 12 This is a schematic diagram of the delivery state in which an anchoring element and an artificial valve are delivered simultaneously, according to this application.

[0045] Figures 13A-13C This is a schematic diagram showing the state of an artificial valve implantation system of this application before and after implantation of an anchor and an artificial valve into the heart.

[0046] Component designation

[0047] 10: Artificial valve assembly; 100: Anchor; 101: Clamping part; 200: Artificial valve; 201: Artificial leaflet; 202: Support structure; M: Long axis; N: Short axis; 111: Inner clamping part; 121: Outer clamping part; 102: First structure; 103: Second structure; 131: First connector; 121a: First head end; 121b: First strut; 111a: First component; 111a-1: Second head end; 111a-2: Second strut; 111b: Second... Components; 111b-1: Third head end; 111b-2: Third support; 141: Clamping reinforcement; 151: First fastener; 161: Control unit; 1611: Hole; 1614: Side support rod; 1612, 1613: Support rod; 1511: Fabric or membrane; Diagonal support rod 1512; 212: Elastic structural unit; 222: Seal; 232: Extension; 242: Fitting part; 20: Conveying device; 210: Sheath; 203: Pull wire, connector; 300: Connecting rope. Detailed Implementation

[0048] To enable those skilled in the art to better understand the technical solutions in the embodiments of this application, the technical solutions in the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art should fall within the protection scope of the embodiments of this application.

[0049] The term "proximal" refers to the end of the artificial valve assembly that is closer to the atrium or ventricle when it is implanted in the heart. The term "distal" refers to the end of the artificial valve assembly that is furthest from the atrium or ventricle when it is implanted in the heart.

[0050] "Inflow end" and "outflow end" refer to the direction of blood flow from the atria into the ventricles via the heart valves.

[0051] The "peak" of an elastic structural unit refers to the top of the long axis of the elastic structural unit, and the "trough" refers to the bottom of the long axis of the elastic structural unit.

[0052] The term "top" refers to the end of the support structure that is close to or located in the left atrium when the artificial valve is implanted in the heart, and the term "bottom" refers to the end of the support structure that is close to or located in the left ventricle when the artificial valve is implanted in the heart.

[0053] The term "fitting" refers to the structural and / or shaped adaptation between two components, which may or may not have a locking relationship.

[0054] The artificial valve assembly of this application is suitable for at least partially replacing the native mitral or tricuspid valve of the human heart. The embodiments of this application will be described using the mitral valve as an example.

[0055] like Figure 1 As shown, the mitral valve, also known as the left atrioventricular valve, is a barrier formed between the left ventricle and left atrium. Normally, the opening and closing of the mitral valve is regulated by the pressure difference between the left atrium and left ventricle. During diastole, the pressure in the left atrium is greater than that in the left ventricle, and the mitral valve opens; conversely, during systole, the pressure in the left ventricle is greater than that in the left atrium, and the mitral valve closes. Compared to the aortic valve, the mitral valve has a D-shaped overall structure, a larger annulus, and less calcification. If an artificial valve is implanted, the native mitral valve cannot provide sufficient support for the artificial valve, causing it to become fixed at the diseased mitral valve site. Furthermore, since the left ventricular outflow tract is adjacent to the anterior leaflet of the mitral valve, the implantation of an artificial valve may also cause left ventricular outflow tract obstruction (LVOTO). Because patients with mitral regurgitation have larger mitral valve annulus sizes, the normal annulus diameter is between 27-35 mm, and the dilated annulus diameter is between 35-48 mm. Without an anchor, relying solely on the artificial valve's support structure, the diameter of the support structure needs to be above 30 mm. The diameter of the outer layer of existing artificial valves is above 43 mm. Therefore, this application's embodiment adopts a separate anchor and artificial valve structure, mainly for two purposes: 1. After the anchor is implanted, it provides a suitable diameter for the artificial valve, allowing smaller artificial valves (e.g., below 35 mm) to be implanted; 2. It clamps the leaflets to prevent the anterior leaflet from obstructing the left ventricular outflow tract and causing left ventricular outflow tract obstruction.

[0056] The specific implementation of the embodiments of this application will be further described below with reference to the accompanying drawings.

[0057] See Figures 2 to 12In one specific implementation of this application, an artificial valve assembly 10 is provided, which can be delivered and released to the heart via a delivery device 20 to partially or completely replace the heart's native valve. The native valve includes a native annulus and a native leaflet. The artificial valve assembly 10 includes: an anchor 100 having a clamping portion 101 for clamping part or all of the native leaflet; and an artificial valve 200 having an artificial leaflet 201 and a support structure 202 connected to the artificial leaflet 201 for supporting the artificial leaflet 201. The artificial valve 200 cooperates with the anchor 100, for example, the artificial valve 200 and the anchor 100 are shaped and / or structurally compatible. The artificial valve 200 can be placed inside or outside the anchor 100.

[0058] The anchor 100 and the artificial valve 200 are structurally independent, and both the anchor 100 and the artificial valve 200 are in a compressed state during delivery (e.g., Figure 3 and 4 As shown), they are all in an expanded state upon release (as shown). Figure 2 As shown, after the anchor 100 and artificial valve 200 are delivered to the heart via the delivery device 20 in a compressed state, the anchor 100 is first released so that the clamping part 101 clamps at least a portion of the original leaflet. By applying a pulling force to at least a portion of the clamped original leaflet, the clamped original leaflet is engaged in the clamping part 101 of the anchor 100, thereby positioning the anchor 100 at the original leaflet. Then, the artificial valve 200 is released to cooperate with the anchor 100. Both the anchor 100 and the artificial valve 200 can be radially compressed and expanded. After being radially compressed to a certain diameter, they can be delivered to a designated position via the delivery device 20.

[0059] Since the anchor 100 and artificial valve 200 in the artificial valve assembly 10 of this application embodiment are independent structures, they can be delivered or released to the heart separately. For example, the anchor 100 can be released first, and the anchor can be implanted to provide a suitable anchoring diameter for the artificial valve 200. Then, the artificial valve 200 can be released, allowing the use of a smaller diameter delivery system, reducing the difficulty of sheath bending, minimizing damage to blood vessels, and preventing the anterior leaflet from obstructing the left ventricular outflow tract. In addition, the diameter Ø of the clamping part 101 is smaller than the diameter of the original valve annulus, facilitating the implantation of an appropriately sized artificial valve 200, thereby extending the service life of the artificial valve 200.

[0060] like Figures 5A to 5JIn an optional embodiment, the clamping part 101 is provided with an inner clamping member 111 and an outer clamping member 121. The inner clamping member 111 and the outer clamping member 121 are respectively used to clamp the inner and outer sides of the original leaflet. When the original leaflet is clamped by the inner clamping member 111 and the outer clamping member 121, the original leaflet will be clamped between the inner clamping member 111 and the outer clamping member 121 due to the pulling force towards the clamping part 101. Therefore, the original leaflet will form a diameter approximately similar to the diameter Ø of the clamping part 101.

[0061] In one embodiment of this application, both the inner clamping member 111 and the outer clamping member 121 are elastic. In the expanded state, the inner clamping member 111 and the outer clamping member 121 together form a first structure 102 that is approximately tubular or non-tubular (e.g., a hollow cube or other arbitrary hollow body). In the compressed state, the tubular first structure 102 is radially compressed to form a tubular or approximately bundled second structure 103 with a smaller diameter, and the non-tubular first structure 102 is compressed to form a second structure 103 with a smaller effective diameter.

[0062] As an optional embodiment, the inner clamping member 111 and the outer clamping member 121 are distributed at intervals along the circumference of the first structure 102, and the height of the inner clamping member 111 is greater than the height of the outer clamping member 121. Adjacent inner clamping members 111 and outer clamping members 121 are connected by a first connector 131.

[0063] Figures 5A-5F Various alternative configurations are shown where the inner clamping member 111 and the outer clamping member 121 are spaced apart circumferentially along the first structure 102. The reason why the height of the inner clamping member 111 is greater than the height of the outer clamping member 121 is to facilitate the outer clamping member 121 being disengaged from the sheath of the conveying device 20 first (e.g., when the anchoring member 100 is released from the sheath of the conveying device 20). Figure 5A As shown), to capture the native leaflet, due to the higher height of the inner clamp 111, the inner clamp 111 detaches from the sheath to clamp the captured native leaflet together with the outer clamp 121.

[0064] The first connector 131 can be a U-shaped structure, or other shapes suitable for connecting adjacent inner clamping parts 111 and outer clamping parts 121.

[0065] In an optional embodiment, the outer clamping member 121 has a first end 121a and two first struts 121b interconnected; the anchoring member 100 also has a second end 111a-1; the inner clamping member 111 includes at least one of the following components: a first component 111a having two second struts 111a-2 interconnected with the second end 111a-1, and the second end 111a-1 extending radially outward from the two second struts 111a-2 along the first structure 102; and a second component 111b having a third end 111b-1 and two third struts 111b-2 interconnected. The anchoring member 100 is fixed to the original leaflet by the clamping force between adjacent struts of the inner and outer clamping members 121, providing an anchoring position for the artificial valve 200.

[0066] like Figures 5A-5C The inner clamping member 111 includes a first component 111a and a second component 111b. Both the second end 111a-1 and the third end 111b-1 have an inverted U-shaped structure. The inverted U-shaped structure of the second end 111a-1 extends outward from the second support column 111a-2 along the radial direction of the first structure 102. The plane containing the inverted U-shaped structure of the second end 111a-1 forms an angle θ1 with the plane containing the second support column 111a-2, where 0° < θ1 < 180°. The inverted U-shaped structure of the second end 111a-1 serves to fix the clamping part 101. That is, after the anchor 100 is released and the inner clamping part 111 and the outer clamping part 121 clamp the original leaflet, the inverted U-shaped structure of the second end 111a-1 can be locked onto the lateral wall of the left atrium or the valve annulus, increasing the anchoring force. This prevents the anchor 100 from falling into the left ventricle due to the periodic diastole of the left ventricle. The second end 111a-1 can also be other shapes, such as arc, trapezoid, V, W, rhombus, wavy, etc. At least one of the first, second, and third pillars can also have several diagonal support rods connected to each other on the inner side to form V-shaped, W-shaped, rhombus, wavy structures, etc., to enhance the supporting force of the inner clamping part 111 and the outer clamping part 121.

[0067] Optionally, the effective diameter Ø of the tip of the clamping portion 101 in the expanded state is smaller than the diameter of the original valve ring. When the clamping portion 101 is tubular, the "effective diameter" refers to the diameter of the clamping portion 101; when the clamping portion 101 is non-tubular, the "effective diameter" refers to the longest length of the clamping portion 101 in cross-section. For example, when the clamping portion 101 is elliptical, the effective diameter of the clamping portion 101 is the length of the major axis of the ellipse. Regardless of the shape of the clamping portion 101, the "effective diameter Ø" does not include the length of the second end and the first fixing member.

[0068] like Figure 5BThe first support column 121b and its adjacent second and third supports 111a-2 are provided with clamping reinforcement portions 141, each extending outward from the first support column 121b, the second support column 111a-2, and the third support column 111b-2. Since clamping reinforcement portions 141 are provided between adjacent first support columns 121b, second support columns 111a-2, and third support columns 111b-2, the clamping force on the original leaflet can be enhanced when the inner clamping member 111 and the outer clamping member 121 clamp the original leaflet from the inside and outside, respectively. The clamping reinforcement portions 141 can be linear or arc-shaped, and are distributed at an angle not exceeding 90° with the first support column 121b, the second support column 111a-2, and the third support column 111b-2. Figure 5C As shown, the first pillar 121b and the adjacent third pillar 111b-2 are provided with a wave-shaped clamping reinforcement 141. The clamping reinforcement 141 is part of the first pillar 121b and the third pillar 111b-2, and has at least one crest or trough. The crests of the clamping reinforcement 141 on the adjacent first pillar 121b, second pillar 111a-2 and third pillar 111b-2 are opposite to each other, which enhances the clamping force of the inner clamping member 111 and the outer clamping member 121 on the original leaflet.

[0069] In another embodiment, such as Figures 5D-5F The anchoring member 100 also has at least one first fixing member 151. The inner clamping member 111 includes a plurality of second members 111b, does not include the first member 111a, and has a third end 111b-1 with an inverted U-shaped structure. The two ends of each first fixing member 151 can be connected to the third end 111b-1 of two second members 111b respectively through connecting posts, thereby... Figures 5D-5E As shown, the first fixing member 151 can be semi-circular, trapezoidal, V-shaped, W-shaped, wavy, U-shaped, a combination of the above shapes, or any other suitable shape. A W-shaped or wavy first fixing member 151 can increase the anchoring area in the left atrium and increase the anchoring force. For example... Figure 5G As shown, the inner side of the first fixing member 151 may also be provided with several inclined support rods 1512 connected to each other to form V-shaped, W-shaped, rhomboid, wave-shaped structures, etc., to enhance the supporting force of the first fixing member 151.

[0070] like Figure 5G As shown, as an optional embodiment, the inner sides of the first pillar 121b, the second pillar 111a-2 and the third pillar 111b-2 are provided with several connected diagonal support rods to form V-shaped, W-shaped, rhomboid, wave-shaped and other structures to enhance the supporting force of the inner clamping member 111.

[0071] In one embodiment of this application, the outer clamping member 121 is provided with a control unit 161 for connection to the conveying device 20. The conveying device 20 controls the control unit 161 to expand the outer clamping member 121 so as to place at least a portion of the original leaflet between the inner clamping member 111 and the outer clamping member 121. The control unit 161 may be U-shaped, V-shaped, circular, square or other shapes. The control unit 161 may be connected to the first support column 121b of the outer clamping member 121 and is provided on the inner or outer side of the outer clamping member 121.

[0072] like Figures 5A-5B , Figure 13A As shown, the control unit 161 may be provided with at least one hole 1611. The conveying device 20 can control the control unit 161 through the pull wire 203. Under the pulling force of the pull wire 203, the outer clamping member 121 will open at a certain angle, and a gap will be formed between the inner clamping member 111 and the outer clamping member 121, which is convenient for capturing the original petal leaf. Then the pull wire 203 is withdrawn, and the captured original petal leaf is clamped between the outer clamping member 121 and the inner clamping member 111.

[0073] like Figure 5H As shown, in an optional embodiment, the control unit 161 includes a side support rod 1614 extending from the inner side of the outer clamping member 121, i.e., the inner side of the two first pillars 121b. Another support rod 1612 extends longitudinally from the intersection of the side support rods 1614, forming a Y-shaped structure. The head end of the Y-shaped structure is provided with a hole 1611 for passing through the pull wire 203 to control the opening and closing of the outer clamping member 121.

[0074] like Figure 5I As shown, in another alternative embodiment, the control unit 161 includes a rod 1613 extending directly from the first end 121a of the outer clamping member 121. The rod 1613 has a hole 1611 at its end for the pull wire 203 to pass through, thereby controlling the opening and closing of the outer clamping member 121. Both embodiments described above allow the tension applied through the pull wire 203 to act on the top of the outer clamping member 121, making it easier to open. The structure and shape of the control unit 161 are not limited to these embodiments and can be any other suitable structure.

[0075] like Figure 11 As shown, optionally, the outer surface of the second head end 111a-1 or the first fixation member 151 is covered with a biocompatible fabric or membrane 1511. The fabric or membrane 1511 can promote endothelialization after the anchor member 100 is implanted.

[0076] like Figure 6As shown, in an optional embodiment, in the expanded state, the shape of the support structure 202 is approximately the same as the shape of the clamping portion 101. When the shape of the clamping portion 101 is approximately tubular, the shape of the support structure 202 is also approximately tubular, and the diameter of the support structure 202 is smaller than the diameter Ø of the first structure 102, so that the support structure 202 is placed inside the first structure 102. Figure 4 As shown, in the compressed state, the support structure 202 is radially compressed to form a tubular or approximately bundled structure with a smaller diameter. The diameter of the support structure 202 in the compressed state can be less than or equal to the diameter of the second structure 103.

[0077] like Figures 6-10 As shown in one embodiment of this application, the support structure 202 has multiple elastic structural units 212, which are evenly distributed along the circumference of the support structure 202. When subjected to circumferential force, each elastic structural unit 212 can deform simultaneously along the major axis M and the minor axis N. For example, when subjected to compressive force, the major axis of each elastic structural unit 212 becomes longer and the minor axis becomes shorter, that is, the elastic structural unit 212 is compressed into a strip shape, and then the support structure 202 is radially compressed into a tubular or bundle-like structure with a smaller diameter. Optionally, the artificial valve 200 also has a sealing element 222, which covers the outer surface of the support structure 202 to fill the gap between the support structure 202 and the clamping part 101 and to provide a seal, increasing the friction between the two, reducing paravalvular leakage while increasing the anchoring force of the artificial valve 200 on the anchoring element 100. The elastic structural unit 212 can be rhomboid, parallelogram, hexagon, a combination thereof, or any other suitable shape.

[0078] like Figures 7A-7B As shown, the artificial valve 200 also has an extension 232, which extends from the surface of the elastic structural unit 212 in a direction away from the surface, such that the circumferential diameter formed by the end of the extension 232 is greater than the effective diameter of the clamping part 101.

[0079] like Figure 7A As shown, one or more radially outward extensions 232 are provided at the outflow end of the support structure 202. The extension 232 can be part of the elastic structural unit 212, and its shape can be V-shaped, U-shaped, W-shaped, etc., or it can be an independent support rod. The extension 232 forms a certain angle θ2 with the central axis of the support structure 202, where 0° < θ2 < 180°. When the artificial valve 200 is implanted into the anchor 100, the extension 232 abuts against the first connector 131, which can prevent the artificial valve 200 from falling into the left atrium under the pressure of the left ventricle. When θ2 < 90°, the abutment effect of the extension 232 against the first connector 131 is better.

[0080] like Figure 7BAs shown, the extension 232 can be a single support rod that extends in the opposite direction from the outflow end of the support structure 202 to the inflow end of the support structure 202. The extension 232 is connected to the crest or trough of the elastic structural unit 212 at the outflow end to form a U-shaped structure.

[0081] like Figures 8A-8D As an optional embodiment, the inflow end of the support structure 202 may be provided with one or more mating portions 242 that cooperate with the first member 111a. The mating portions 242 extend radially outward from the support structure 202 and are used to cooperate with the inner clamping member 111. The mating portions 242 may be semi-circular, trapezoidal, V-shaped, W-shaped, wavy, U-shaped, etc. Both ends of the mating portions 242 are connected to the top of the inflow end of the support structure 202 at a certain angle and extend radially outward along the outer surface of the support structure 202. Figure 10 As shown, when the support structure 202 is released, the mating part 242 passes through the top end of the second component 111b of the inner clamping member 111, realizing the connection between the artificial valve 200 and the anchoring member 100. The anchoring member 100 can position and support the artificial valve 200. During cardiac contraction, because the artificial valve 200 is supported by the anchoring member 100, it can be prevented from dislodging into the ventricle under the pressure of the atrium.

[0082] like Figures 8B-8C The connection between the mating part 242 and the support structure 202 can be the trough or peak of the elastic structural unit 212 at the inflow end of the support structure 202. When the connection part is located at the trough of the elastic structural unit 212 at the inflow end, the fatigue performance of the mating part 242 can be enhanced.

[0083] like Figure 8D The mating part 242 can also be the crest of the elastic structural unit 212 at the inflow end of the support structure 202 directly turned outward, or extended from the crest of the elastic structural unit 212 at the inflow end, thereby reducing the height of the valve stent.

[0084] Figures 8A-8C The structural form of the mating part 242 is also applicable to the extension 232 located at the outlet end of the support structure 202.

[0085] like Figures 9A-9C As shown, the elastic structural units 212 can be distributed in various ways. Two adjacent elastic structural units 212 can be crest to trough, and the crests and troughs can be directly connected to form a distribution like... Figure 7A The shape shown is a quadrilateral; or the crests and troughs are connected by connecting rods to form a hexagon (such as...). Figure 9A (as shown); or quadrilaterals and hexagons superimposed (as shown). Figure 9B (As shown); or crest to crest, trough to trough, with some or all troughs connected by connecting rods (as shown).Figure 9C ).

[0086] The artificial valve 200 and the anchor 100 can be manufactured by laser cutting, braiding, mechanical riveting, welding, etc. The inflow diameter of the artificial valve assembly 10 formed by the artificial valve 200 and the anchor 100 can be equal to or greater than the outflow diameter. When the inflow diameter is greater than the outflow diameter, the inflow end of the artificial valve assembly 10 can be fixed at the larger diameter native valve annulus, while the smaller diameter outflow end located in the ventricular portion can reduce the risk of left ventricular outflow tract obstruction.

[0087] This application also provides an artificial valve implantation system, which includes an artificial valve assembly 10 and a delivery device 20, the delivery device 20 including a sheath 210 for receiving and delivering the anchor 100 and the artificial valve 200 to the heart.

[0088] As an optional embodiment, the delivery device 20 further includes: a connector 203 for connection to the control portion 161 of the anchor 100; and a control member connected to the connector 203 for controlling the control portion 161 of the anchor 100 via the connector 203, so that the clamping portion 101 clamps at least a portion of the original leaflet. The connector 203 can be a wire, a rod, or any other suitable connection structure. During delivery, the anchor 100 and the artificial valve 200 can be delivered separately; the anchor 100 is delivered first and released into the heart, followed by the delivery and release of the artificial valve 200. During delivery, the anchor 100 and the artificial valve 200 can also be delivered simultaneously. That is, the anchor 100 and the artificial valve 200 are placed in the sheath 210 at the same time, with the anchor 100 placed at the distal end of the sheath 210 and the artificial valve 200 placed at the proximal end of the sheath 210. The anchor 100 is released first, and then the artificial valve 200 is released, so that the artificial valve 200 is placed inside the clamping part 101 of the anchor 100. In an optional embodiment, to ensure that the mating part 242 and the second component 111b can be accurately aligned and engaged during release, the anchoring member 100 and the artificial valve 200 are connected to each other. During pre-assembly, the mating part 242 and the second component 111b are aligned and installed. For example, the inner clamping member 111 and the support structure 202 are connected by a connecting rope 300. The connecting rope 300 serves both to fix and guide. The anchoring member 100 and the artificial valve 200 are in a connected state during delivery and release, which facilitates accurate alignment and engagement between the mating part 242 and the second component 111b during release and prevents the artificial valve from falling out into the ventricle when subjected to atrial pressure.

[0089] In another aspect, this application also provides a method for implanting an artificial valve, comprising: simultaneously or stepwise delivering an anchor 100 in a compressed state and an artificial valve 200 to the heart; first releasing the anchor 100 so that a clamping portion 101 clamps at least a portion of the original leaflet, and by applying a pulling force to at least a portion of the clamped original leaflet, clamping at least a portion of the clamped original leaflet into the clamping portion 101 of the anchor 100; and then releasing the artificial valve 200 so that it engages with the anchor 100.

[0090] like Figure 10 and Figure 12 As shown, the anchor 100 and the artificial valve 200 can be transported simultaneously. To ensure accurate alignment and engagement of the mating part 242 and the second component 111b of the inner clamping part 111 during release, the mating part 242 and the second component 111b are installed vertically aligned during pre-assembly, and connected by a connecting rope. The connecting rope serves both as a fixation and guide, connecting the anchor 100 and the artificial valve 200 together to prevent the artificial valve 200 from dislodging into the ventricle under atrial pressure. The control element is connected to the pull wire 203. During the transport of the anchor 100, the control element controls the pull wire 203. During pre-assembly, the anchor 100 is compressed and placed inside the sheath 210 to facilitate control of the opening and closing of the inner clamping part 111 and the outer clamping part 121 and the capture of the valve leaflets.

[0091] like Figures 13A-13CAs an optional embodiment, the artificial valve implantation method includes: first, pre-installing the anchor 100 into the sheath 210 of the delivery device 20; the operator delivers the delivery device 20 into the left ventricle via the patient's blood vessels from proximal to distal; the operator adjusts the distance between the distal end of the sheath 210 and the outflow end of the anchor 100; the operator controls the cable 203 to first release the outer clamp 121 of the anchor 100 using the control of the delivery device 20; the inner clamp 111 remains in the sheath 210; the outer clamp 121 opens at a certain angle, creating a gap between the outer clamp 121 and the inner clamp 111, capturing the anterior and posterior leaflets of the mitral valve; then the cable 203 is withdrawn, and the inner clamp 111 is gradually released, clamping the captured native leaflets between the outer clamp 121 and the inner clamp 111; finally, the sheath 210 is withdrawn to completely release the anchor 100. Then, the artificial valve 200 is delivered through the sheath 210 and released inside the tubular structure formed by the anchor 100. The artificial valve 200 changes from a compressed state to an expanded state, and the outer side of the artificial valve 200 is positioned inside the anchor 100. The artificial leaflet 201 is located at the bottom end of the clamping part 101. The extension 232 at the outflow end of the support structure 202 abuts against the first connector 131 to prevent the artificial valve 200 from falling into the left atrium. The mating part 242 at the inflow end of the support structure 202 passes through the top of the second member 111b of the inner clamping part 111, so that the artificial valve 200 is firmly connected to the anchor 100 to prevent the artificial valve 200 from falling into the left ventricle. The delivery device 20 is withdrawn, and the artificial valve 200 and the anchor 100 are fixed on the mitral valve, thereby replacing the original mitral valve.

[0092] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the embodiments of this application, and are not intended to limit them; although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the foregoing embodiments, or make equivalent substitutions for some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application.

Claims

1. An artificial valve assembly, delivered and released to the heart via a delivery device to at least partially replace the heart's native valve, wherein, The native valve includes a native annulus and native leaflets, characterized in that the artificial valve assembly comprises: An anchor has a clamping portion for clamping at least a portion of the original leaflet; Artificial valves have the following characteristics: Artificial leaflets; A support structure, which is connected to the artificial leaflet, is used to support the artificial leaflet; The artificial valve cooperates with the anchor, and the anchor and the artificial valve are structurally independent of each other. Both the anchor and the artificial valve are in a compressed state during delivery and in an expanded state during release. After the anchor and the artificial valve are delivered to the heart via the delivery device in a compressed state, the anchor is first released so that the clamping part clamps at least a portion of the original leaflet, thereby positioning the anchor at the original leaflet. Then the artificial valve is released to cooperate with the anchor. The clamping part has an inner clamping member and an outer clamping member, which are respectively used to clamp the inner and outer sides of the original leaflet, thereby applying a tensile force to at least a portion of the clamped original leaflet so that the original leaflet forms a diameter close to that of the clamping part; wherein, in the expanded state, the inner clamping member and the outer clamping member together form an approximately tubular first structure, the outer clamping member has a first end and two first supports connected to each other, and the inner clamping member includes at least one of the following components: The first component has a second end and two second supports that are interconnected, the second end extending radially outward from the two second supports along the first structure; The second component has a third head end and two third supports that are interconnected; The support structure is provided with at least one mating part that mates with the first component. The mating part extends outward from the radial direction of the support structure and is used to mate with the inner clamping member so that the artificial valve is fixedly connected to the anchoring member.

2. The artificial valve assembly according to claim 1, characterized in that, The effective diameter of the tip of the clamping part in the expanded state is smaller than the diameter of the original valve ring.

3. The artificial valve assembly according to claim 1, characterized in that, The inner clamping member and the outer clamping member are elastic. Under compression, the inner clamping member and the outer clamping member are radially compressed to form a tubular or approximately bundle-shaped second structure with a smaller diameter than the first structure.

4. The artificial valve assembly according to claim 3, characterized in that, The inner clamping member and the outer clamping member are distributed at intervals along the circumference of the first structure, and the height of the inner clamping member is greater than the height of the outer clamping member. Adjacent inner clamping members and outer clamping members are connected by a first connector.

5. The artificial valve assembly according to claim 4, characterized in that, The first connector has a U-shaped structure.

6. The artificial valve assembly according to claim 1, characterized in that, The inner clamping member includes both the first component and the second component. Both the second end and the third end have an inverted U-shaped structure. The inverted U-shaped structure of the second end extends radially outward from the second support column along the first structure. The plane containing the inverted U-shaped structure of the second end forms an angle θ1 with the plane containing the second support column, where 0° < θ1 < 180°.

7. The artificial valve assembly according to claim 1, characterized in that, The first pillar and the adjacent second and / or third pillar are provided with clamping reinforcements, each of which extends outward from the first, second and / or third pillar or is part of the first, second and / or third pillar, for enhancing the clamping force between the inner clamping member and the outer clamping member.

8. The artificial valve assembly according to claim 1, characterized in that, At least one of the first, second, and third pillars has a plurality of connected diagonal braces on its inner side to enhance the support force of the inner clamping member and the outer clamping member.

9. The artificial valve assembly according to claim 1, characterized in that, The anchor also has at least one first fixing member, the inner clamping member includes a plurality of the second members, and the third end has an inverted U-shaped structure, with each of the first fixing members connected to two of the third ends respectively.

10. The artificial valve assembly according to claim 3, characterized in that, The outer clamping member is provided with a control unit for connecting to the conveying device, and the control unit is controlled by the conveying device to drive the outer clamping member to open and close, so as to place at least a portion of the original leaflet between the inner clamping member and the outer clamping member.

11. The artificial valve assembly according to claim 9, characterized in that, The outer surface of the second end or the first fastener is covered with a biocompatible fabric or membrane.

12. The artificial valve assembly according to claim 3, characterized in that, In the expanded state, the support structure is approximately tubular in shape, and the diameter of the support structure is smaller than the diameter of the first structure, so that the support structure is placed inside the first structure; in the compressed state, the support structure is radially compressed to form a tubular or approximately bundle-like structure with a smaller diameter.

13. The artificial valve assembly according to claim 12, characterized in that, The support structure has multiple elastic structural units that are evenly distributed along the circumference of the support structure. When subjected to circumferential force, each elastic structural unit can deform simultaneously along the major axis and the minor axis.

14. The artificial valve assembly according to claim 13, characterized in that, The artificial valve also has at least one extension that extends from the surface of the elastic structural unit in a direction away from the surface, such that the circumferential diameter formed by the end of the extension is larger than the diameter of the clamping portion.

15. The artificial valve assembly according to claim 1, characterized in that, The inner clamp is connected to the support structure so that the anchor and the artificial valve are in a connected state during delivery and release.

16. The artificial valve assembly according to claim 1, characterized in that, The artificial valve also has a sealing element that covers the outer surface of the support structure and is used to fill the gap between the support structure and the clamping part.

17. An artificial valve implantation system, comprising: The artificial valve assembly according to any one of claims 1 to 16; A delivery device, comprising a sheath for receiving and delivering the anchor and the artificial valve to the heart.

18. The artificial valve implantation system according to claim 17, characterized in that, The anchor and the artificial valve are placed in the sheath simultaneously, with the anchor located at the distal end of the sheath and the artificial valve located at the proximal end of the sheath.

19. The artificial valve implantation system according to claim 18, characterized in that, The anchor and the artificial valve are connected to each other.

20. The artificial valve implantation system according to claim 17, characterized in that, The conveying device also includes: Connector for connection to the anchor; A control element, connected to the connector, is used to control the clamping portion of the anchor via the connector, so that the clamping portion clamps at least a portion of the original leaflet.

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