Valve prosthesis

Abstract

The invention relates to a valve prosthesis. The valve prosthesis comprises a main body support and a valve leaflet clamp, the valve leaflet clamp comprises a first clamping piece and a second clamping piece, one end of the first clamping piece is connected with the main body support, and the other end of the first clamping piece extends in the axial direction of the main body support to form a free end; one end of the second clamping piece is connected with the body support, the other end of the second clamping piece extends in the axial direction of the body support to form a free end, and the second clamping piece is located on the side, away from the body support in the radial direction, of the first clamping piece. The second clamping piece can rotate relative to the first clamping piece in the axial direction so as to get close to the first clamping piece and be matched with the first clamping piece to clamp the native leaflet or get away from the first clamping piece. In the implanting process of the valve prosthesis, the valve leaflet clamp can be used for clamping the native leaflet firstly, then the main body support is released to enable the main body support and the native leaflet to be close to each other, and therefore the clamping state of the native leaflet can be adjusted.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, and in particular to a valve prosthesis. BACKGROUND

[0002] The part provided in this part is only background information related to the present disclosure, which is not necessarily prior art.

[0003] The heart valve refers to the valve between the atrium and the ventricle or between the ventricle and the artery. The human heart includes four chambers and four heart valves, the four chambers include the left atrium, the left ventricle, the right atrium and the right ventricle, the two atria are connected with the two ventricles respectively, and the two ventricles are connected with the two large arteries, the heart valve is grown between the atrium and the ventricle, the ventricle and the large artery, and the four heart valves are respectively called the mitral valve, the tricuspid valve, the aortic valve and the pulmonary valve. The heart valve plays the role of a one-way valve to ensure the one-way movement of blood flow, and plays an important role in ensuring the normal operation of the heart.

[0004] Heart valve disease is a common heart disease, which is caused by rheumatic fever, mucinous degeneration, degenerative changes, congenital malformation, ischemic necrosis and other reasons, and is caused by single or multiple valve diseases, so that the valve appears stenosis or insufficiency, thereby hindering the normal blood flow, increasing the burden of the heart, and further causing damage to the heart function, leading to heart failure.

[0005] At present, the ways of treating heart valve disease by surgery mainly include surgical thoracotomy and medical minimally invasive intervention surgery. Compared with surgical thoracotomy, the surgical trauma is large, the risk is high, and long-term and expensive rehabilitation treatment is required after surgery. The medical minimally invasive intervention surgery is widely accepted by patients due to its advantages of small trauma, fewer complications and fast postoperative recovery. The medical minimally invasive surgery mainly replaces the native valve by using a valve prosthesis to treat heart valve disease, and one of the technical problems to be solved is how to fix the valve prosthesis on the native valve.

[0006] A commonly used valve prosthesis currently comprises a valve stent and a leaflet hook, the leaflet hook is formed by a curved rod connected to the valve stent, the leaflet hook and the outer wall of the valve stent form a U-shaped structure, in the implantation process, first, the leaflet hook is turned to the side away from the valve stent to make the leaflet hook and the valve stent on the same axis and bound in the delivery device, after the valve prosthesis is delivered to the target position, the leaflet hook and part of the valve stent are released, the leaflet hook is turned to the side close to the valve stent to cooperate with the valve stent to resist the native leaflet after the external force is released, then the entire valve stent is released, the valve stent is fully inflated after the external force is released to cooperate with the leaflet hook to clamp and fix the native leaflet, thereby fixing the valve prosthesis on the native valve. For this valve stent, the complete fixation of the native leaflet and the complete release of the valve stent are synchronous, so that after the native leaflet is clamped, even if the clamping state is not good, for example, the length of the native leaflet clamped by the valve stent is short, it cannot be adjusted again, thereby causing unstable fixation of the valve prosthesis. SUMMARY

[0007] Therefore, it is necessary to provide a valve prosthesis which can adjust the clamping state of the native leaflet.

[0008] The embodiment of the present application provides a valve prosthesis, which comprises a main stent and a leaflet clamp, the main stent is provided with a lumen, the leaflet clamp comprises: a first clamping piece, one end of which is connected to the main stent, and the other end extends along the axial direction of the main stent to form a free end; and a second clamping piece, one end of which is connected to the main stent, and the other end extends along the axial direction of the main stent to form a free end, the second clamping piece is located on the side of the first clamping piece which is radially away from the main stent, and the second clamping piece can rotate relative to the first clamping piece in the axial direction to approach the first clamping piece to clamp the native leaflet together with the first clamping piece or to move away from the first clamping piece.

[0009] In one embodiment, the first clamping piece comprises a first connecting part and a first clamping part, one end of the first connecting part is connected to the main stent, and the other end is radially bent to be connected to the first clamping part, the first clamping part extends axially from the end connected to the first connecting part to the direction away from the first connecting part, the second clamping piece comprises a second connecting part and a second clamping part, one end of the second connecting part is connected to the main stent, and the other end is radially bent to be connected to the second clamping part, the second clamping part extends axially from the end connected to the first connecting part to the direction away from the second connecting part, and when the second clamping piece approaches the first clamping piece, the second clamping part abuts against the first clamping part to clamp the native leaflet.

[0010] In one embodiment, the first connecting part comprises a straight rod segment and a curved segment, one end of the straight rod segment is connected to the body support, the other end extends along the axial direction of the body support, one end of the curved segment is connected to the end of the straight rod segment not connected to the body support, the other end is connected to the first clamping part, and the first clamping part can drive the curved segment to deform to rotate in the axial direction relative to the body support to approach or move away from the body support.

[0011] In one embodiment, the curved segment is curved radially outward from the end connected to the straight rod segment, and then curved radially inward to be connected to the first clamping part.

[0012] In one embodiment, the projection area of the first clamping part on the body support is greater than the projection area of the first connecting part on the body support.

[0013] In one embodiment, the first clamping part comprises a closed wire frame and a first film filled in the closed wire frame.

[0014] In one embodiment, the projection area of the second connecting part on the body support is less than the projection area of the second clamping part on the body support.

[0015] In one embodiment, the second clamping part is formed by a curved rod, both free ends of the curved rod are connected to the body support, the middle segment of the curved rod extends along the axial direction of the body support and is contracted in the circumferential direction to form the second clamping part, and the circumferential width of the second clamping part matches the circumferential width of the first clamping part.

[0016] In one embodiment, the second connecting part comprises two curved rods, the second clamping part is a contact frame with a circumferential width greater than that of the first clamping part, and both ends of the two curved rods are connected to the body support and the contact frame.

[0017] In one embodiment, the body support comprises a plurality of connected axial struts and circumferential struts, the circumferential struts are connected end to end to form a plurality of wave-shaped rings arranged in the axial direction of the body support, and in the plurality of wave-shaped rings, the peaks of one wave-shaped ring and the peaks of the adjacent wave-shaped ring are connected by the axial struts on the same axis, or the peaks of one wave-shaped ring and the valleys of the adjacent wave-shaped ring are directly connected on the same axis.

[0018] In one embodiment, the valve prosthesis further comprises a leaflet structure arranged on the body support, and the leaflet structure can be opened or closed to make the lumen in an open or closed state.

[0019] The valve prosthesis provided by the embodiment of the present application can realize clamping of the native leaflet by the leaflet clamp itself without cooperation with the main body support, because the leaflet clamp is provided with the first clamping member and the second clamping member, and the second clamping member can rotate around the axis to approach or move away from the first clamping member. Therefore, the approaching step and the clamping step are separated during implantation of the valve prosthesis, so that the clamping state of the native leaflet is adjustable, and the main body support can be released after the clamping state of the native leaflet is adjusted, thereby facilitating stable fixation of the valve prosthesis and promoting application of the valve prosthesis. BRIEF DESCRIPTION OF DRAWINGS

[0020] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed in the embodiment description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative effort.

[0021] Among them:

[0022] Figure 1 FIG. 1 is a structural schematic view of a valve prosthesis according to an embodiment of the present application;

[0023] Figure 2 FIG. 2 is a structural schematic view of the valve prosthesis of FIG. 1 from another perspective;

[0024] Figure 3 FIG. 3 is a structural schematic view of a leaflet clamp according to an embodiment of the present application;

[0025] Figure 4 FIG. 4 is a structural schematic view of the leaflet clamp of FIG. 3 from another perspective;

[0026] Figure 5 FIG. 5 is a structural schematic view of a leaflet clamp according to another embodiment of the present application. DETAILED DESCRIPTION

[0027] The technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings of the embodiments of the present application. Obviously, the described embodiments are only some embodiments of the present application, rather than all the embodiments. Based on the embodiments of the present application, all other embodiments obtained by those skilled in the art without creative effort fall within the scope of the present application.

[0028] In the description of the embodiments of the present application, it should be noted that the orientation or positional relationship indicated by terms such as "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer" and the like is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the embodiments of the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the embodiments of the present application. In addition, the terms "first", "second", "third" are only for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0029] In the description of the embodiments of the present application, it should be noted that unless otherwise explicitly specified and limited, the terms "mounting", "connecting", "connecting" should be understood broadly, for example, it can be fixedly connected, or it can be replaceably connected, or it can be integrally connected, it can be mechanically connected, or it can be electrically connected, it can be directly connected, or it can be indirectly connected through an intermediate medium, it can be the communication inside two elements. For those skilled in the art, the specific meaning of the above terms in the embodiments of the present application can be understood according to the specific circumstances.

[0030] In the field of interventional medical devices, the end of a medical device implanted in the human or animal body closer to the operator is generally referred to as the "proximal end", and the end farther away from the operator is referred to as the "distal end", and the "proximal end" and "distal end" of any component of the medical device are defined according to this principle. "Axial" generally refers to the length direction of the medical device when it is being delivered, "radial" generally refers to the direction of the medical device that is not parallel to its "axial" direction, and the "axial" and "radial" directions of any component of the medical device are defined according to this principle. "Circumferential" refers to the circumferential direction, i.e. the direction around the axis of the lumen structure, the cylinder.

[0031] Please refer to Figure 1 An embodiment of the present application provides a valve prosthesis 100 for implanting into the position of a mitral valve to treat mitral stenosis or regurgitation. It can be understood that in other embodiments, it can also be implanted into other positions such as the tricuspid valve, aortic valve or pulmonary valve to treat valvular diseases.

[0032] Please continue to refer to Figure 1 In an embodiment, the valve prosthesis 100 includes a main body stent 10, a leaflet clamp 20, and a leaflet structure (not shown).

[0033] The main body support 10 is provided with a lumen 101, and blood can flow through the lumen 101. The leaflet clamp 20 is connected to the main body support 10 at one end and is free at the other end. The leaflet clamp 20 is used to clamp the native leaflet when the valve prosthesis 100 is implanted into the valve lesion position, so as to fix the main body support 10 at the lesion position, thereby replacing the native valve. The leaflet structure is arranged in the main body support 10, and the leaflet structure can be opened or closed, so that the lumen 101 is in an open or closed state.

[0034] Please refer to Figure 2 In an embodiment, the main body support 10 is a single-layer support, which includes a tubular bare frame structure including a plurality of axial struts 11 and a plurality of circumferential struts 12. The axial struts 11 and the circumferential struts 12 are connected to form a lumen structure with open ends, which can switch between a compressed state and an expanded state.

[0035] In an embodiment, the plurality of circumferential struts 12 are arranged in a staggered manner and are connected end to end, thereby forming a plurality of wave-shaped rings 120 arranged along the axial direction of the main body support 10. The plurality of wave-shaped rings 120 can be connected by the axial struts 11 or can be directly connected. In other embodiments, the circumferential struts 12 can also not be connected end to end, for example, the circumferential struts 12 are connected to each other in a staggered manner on the axial struts 11. It can be understood that the number and arrangement of the axial struts 11 and the circumferential struts 12 are not limited, as long as the main body support 10 formed by splicing can switch between the compressed state and the expanded state.

[0036] Please continue to refer to Figure 2 In an embodiment, three wave-shaped rings 120 are arranged, and are arranged in the order of a first wave-shaped ring 1201, a second wave-shaped ring 1202, and a third wave-shaped ring 1203 along the axial direction from the distal end to the proximal end of the main body support 10. The wave-shaped units of the first wave-shaped ring 1201, the second wave-shaped ring 1202, and the third wave-shaped ring 1203 are all “∧”. It should be noted that the distal end and the proximal end in the arrangement order are defined in the state when the main body support 10 is implanted through the cardiac apex. It can be understood that when the main body support 10 is implanted through the atrial septum, the arrangement order of the first wave-shaped ring 1201, the second wave-shaped ring 1202, and the third wave-shaped ring 1203 is actually arranged from the proximal end to the distal end of the main body support 10.

[0037] In an embodiment, the peaks of the first wave ring 1201 are aligned on the same axis as the peaks of the second wave ring 1201, the valleys of the first wave ring 1201 are aligned on the other axis as the valleys of the second wave ring 1202, the axial struts 11 are arranged between the first wave ring 1201 and the second wave ring 1202, one end of the axial strut 11 is connected with the peak or valley of the first wave ring 1201, the other end extends in the axial direction to connect the peak or valley of the second wave ring 1201, so as to connect and fix the first wave ring 1201 and the second wave ring 1202, when the main support 10 is in the expanded state, the axial struts 11 divide the gap between the first wave ring 1201 and the second wave ring 1202 into a plurality of parallelograms. The peaks of the third wave ring 1203 are aligned on the same axis as the valleys of the second wave ring 1202, and the peaks of the third wave ring 1203 are directly connected with the valleys of the second wave ring 1202, the valleys of the third wave ring 1203 are aligned on the same axis as the peaks of the second wave ring 1202 and are separated by a certain distance, so that, when the main support 10 is in the expanded state, the third wave ring 1203 cooperates with the second wave ring 1202 to form a plurality of rhombuses. The arrangement of the first wave ring 1201, the second wave ring 1202 and the third wave ring 1203 can ensure that the main support 10 has good deformability and good stability.

[0038] It can be understood that in other embodiments, the shape, number and arrangement of the wave-shaped rings 120 are not limited. For example, in other embodiments, the wave-shaped units of the wave-shaped rings 120 can be in the shape of a sine wave or other shapes by changing the shape of the circumferential pillars 12. In other embodiments, the number of the wave-shaped rings 120 can also be 4, 5 or 6 or other integers. In other embodiments, the wave crest of the first wave-shaped ring 1201 can be aligned with the wave trough of the second wave-shaped ring 1202 at a distance, and the wave trough of the first wave-shaped ring 1201 can be aligned with the wave crest of the second wave-shaped ring 1202 and directly connected. The wave crest and the wave trough of the third wave-shaped ring 1203 are respectively aligned with the wave crest and the wave trough of the second wave-shaped ring 1202 and connected by the axial pillars 11, so that when the main body support 10 is in the expanded state, the first wave-shaped ring 1201 and the second wave-shaped ring 1202 cooperate to form a plurality of rhombuses, and the plurality of axial pillars 11 divide the distance between the second wave-shaped ring 1202 and the third wave-shaped ring 1203 into a plurality of parallelograms, so that the main body support 10 has good deformability and good stability. Alternatively, in other embodiments, the wave crests of the first wave-shaped ring 1201, the second wave-shaped ring 1202 and the third wave-shaped ring 1203 can be aligned on an axis and connected by the axial pillars 11, and the wave troughs of the three can be aligned on another axis and also connected by the axial pillars 11, so that the main body support 10 has good flexibility.

[0039] Please continue to refer to Figure 2 In an embodiment, the third wave-shaped ring 1203 is a non-complete wave shape, so that a gap is formed on the main body support 10. When the prosthetic valve 100 is implanted on the mitral valve, the gap is placed at the position of the anterior leaflet of the mitral valve, so that the existence of the main body support 10 does not affect the blood flow from the left ventricle along the aorta. It can be understood that the size and position of the gap are not limited, and in other embodiments, the gap can be set according to the blood flow at the implantation target position. When the main body support 10 does not affect the blood flow near the target position, the gap can also be omitted.

[0040] In an embodiment, the main stent 10 is formed by cutting a tubular member, and in other embodiments, the main stent 10 can also be formed by welding the axial struts 11 and the circumferential struts 12 after splicing. The main stent 10 can be made of nickel-titanium alloy, so that the main stent 10 has self-expanding property, and in other embodiments, the main stent 10 can also be made of cobalt-chromium alloy or stainless steel, etc. At this time, the main stent 10 can be switched from the compressed state to the expanded state by balloon expansion. It can be understood that no matter what kind of way or material is used to form the main stent 10, the main stent 10 has the property of being switchable between the compressed state and the expanded state.

[0041] Please continue to refer to Figure 2 In an embodiment, the main stent 10 is further provided with barbs 13, which can hook the tissue to assist in fixation when the main stent 10 is implanted at the target position. For example, when the main stent 10 is implanted at the position of the mitral valve, the barbs 13 hook the native leaflet to assist in fixation. In an embodiment, the barbs 13 are formed by cutting a tubular member and then shaping together with the main stent 10, and in other embodiments, the barbs 13 can also be connected to the main stent 10 by welding.

[0042] Please go back to Figure 1 In an embodiment, the valve prosthesis 100 further comprises a skirt stent 30. The skirt stent 30 is connected to the end of the main stent 10 which is not connected to the leaflet clamp 20 (i.e. the distal end of the main stent 10 when delivered through the apex of the heart), and in an embodiment, the skirt stent 30 is connected to the end of the first wave-shaped ring 1201 away from the second wave-shaped ring 1202. The skirt stent 30 is used to lap the tissue when the valve prosthesis 100 is implanted at the valve lesion position, thereby assisting in fixing the valve prosthesis 100. For example, when the valve prosthesis 100 is implanted at the position of the mitral valve, the skirt stent 30 laps the atrial tissue on the atrial side of the mitral annulus, thereby cooperating with the leaflet clamp 20 to fix the valve prosthesis 100.

[0043] Please continue to refer to Figure 1 In an embodiment, the skirt stent 30 comprises a plurality of radial support rods 310. Each support rod 310 is connected to the main stent 10 at one end and extends along the radial direction of the main stent 10 to form a free end.

[0044] In an embodiment, the free end of the support rod 310 is connected by a plurality of S-shaped rods to form a generally wavy shape. In this way, the flexibility of the support rod 310 is better, and the flexibility of the free end can play a buffering role when the blood flow impacts, thereby reducing the pressure of the support rod 310 on the atrial tissue and improving the compliance of the free end of the support rod 310.

[0045] Please continue to refer toFigure 1 In an embodiment, the skirt support 30 further comprises a plurality of connecting rods 320. One end of the connecting rod 320 is connected to the main support 10, and the other end is connected to the support rod 310. The connecting rod 320 is used to realize the connection between the main support 10 and the support rod 310. In an embodiment, the end of the connecting rod 320 connected to the main support 10 is connected to the peak of the first wave-shaped ring 1201, and the connecting rods 320 are grouped into pairs. The two connecting rods 320 in the same group are connected to the same support rod 310, so that the two connecting rods 320 form a "V-shaped structure", thereby increasing the contact area when the skirt support 30 is in contact with the tissue while ensuring the compliance of the skirt support 30, and ensuring the stability of the skirt support 30 when it is in contact with the tissue.

[0046] Please continue to refer to Figure 1 It should be noted that the main support 10 and the skirt support 30 are both provided with a skirt 40, which is wrapped around the main support 10 and the skirt support 30 to guide the blood flow through the lumen 101. It can be understood that in an embodiment, the skirt 40 wrapped around the main support 10 is cylindrical, and the skirt 40 wrapped around the skirt support 30 is annular. The skirt 40 can be fixed to the main support 10 and the skirt support 30 by sutures. The skirt 40 can be made of polyethylene terephthalate material, or can be made of felt cloth material. The material of the skirt 40 is not limited to the materials mentioned above, and any flexible material that can block blood flow and is suitable for implantation in the human body can be selected. The sutures can be made of polyester, polypropylene, polytetrafluoroethylene and other high molecular materials. In addition, the sutures are not limited to the materials mentioned above.

[0047] It can be understood that in other embodiments, the main support 10 can also be provided as a nested double-layer support, wherein the outer layer support is used to fix the human tissue, the leaflet clamp 20, the barb 13 and the skirt support 30 can all be connected to the outer layer support, and the inner layer support is used to fix the leaflet structure. The lumen 101 is provided in the inner layer support, and the leaflet structure is provided in the inner layer support. There is a gap between the inner layer support and the outer layer support. In this way, when the prosthetic valve 100 is implanted in a valve structure that is non-uniformly cylindrical, such as the mitral valve, the outer layer support can deform under the pressure of the valve structure to adapt to the shape of the valve structure for anchoring. At the same time, the gap between the outer layer support and the inner layer support can act as a buffer, so that the inner layer support can still maintain a cylindrical structure after implantation, thereby avoiding the influence of the valve structure on the opening and closing of the leaflet structure.

[0048] Please refer to Figure 2 In an embodiment, the leaflet clamp 20 comprises a first clamping member 21 and a second clamping member 22.

[0049] The first clamping piece 21 is connected to the main support 10 at one end and extends in the axial direction of the main support 10 to form a free end. The second clamping piece 22 is connected to the main support 10 at one end and extends in the axial direction of the main support 10 to form a free end. The second clamping piece 22 is located on the side of the first clamping piece 21 that is radially away from the main support 10. The second clamping piece 22 can rotate in the axial direction relative to the first clamping piece 21 to approach the first clamping piece 21 to clamp the native leaflet together with the first clamping piece 21 or to move away from the first clamping piece 21.

[0050] By arranging the leaflet clamp 20 to include the first clamping piece 21 and the second clamping piece 22, and the second clamping piece 22 can rotate around the axis to approach or move away from the first clamping piece 21, so that the leaflet clamp 20 itself can clamp the native leaflet without the cooperation of the main support 10. Therefore, during the implantation of the valve prosthesis 100, the native leaflet can be clamped by the leaflet clamp 20 first, and then the main support 10 is released to move towards the native leaflet, that is, the approaching step and the clamping step are separated, so that the clamping state of the native leaflet can be adjusted, and the main support 10 can be released after the clamping state of the native leaflet is adjusted, thereby facilitating the stable fixation of the valve prosthesis 100 and promoting the application of the valve prosthesis 100.

[0051] Please refer to Figure 3 In an embodiment, the first clamping piece 21 includes a first connecting portion 211 and a first clamping portion 212, and the second clamping piece 22 includes a second connecting portion 221 and a second clamping portion 222.

[0052] The first connecting portion 211 is connected to the main support 10 at one end and connected to the first clamping portion 212 at the other end. The first clamping portion 212 extends axially from the end connected to the first connecting portion 211 to the direction away from the first connecting portion 211, and the first clamping portion 212 is the free end of the first clamping piece 21. The second connecting portion 221 is connected to the main support 10 at one end and connected to the second clamping portion 222 at the other end. The second clamping portion 222 extends axially from the end connected to the second connecting portion 221 to the direction away from the first connecting portion 221, and the second clamping portion 222 is the free end of the second clamping piece 22. When the second clamping piece 22 rotates to approach the first clamping piece 21, the second clamping portion 222 abuts against the first clamping portion 212 to clamp the native leaflet.

[0053] Please refer to Figures 2-3 In an embodiment, the first connecting portion 211 is connected to the main support 10 at one end and connected to the first clamping portion 212 at the other end after being radially bent. The first connecting portion 211 includes a straight rod segment 2111 and a bent segment 2112.

[0054] The straight rod section 2111 is connected to the main body support 10 at one end and extends along the axial direction of the main body support 10 at the other end. The curved section 2112 is connected to the end of the straight rod section 2111 that is not connected to the main body support 10 at one end and extends along the axial direction to the side close to the first clamping portion 212 after being radially bent and folded at the other end and is connected to the first clamping portion 212. The curved section 2112 is arranged such that the first clamping portion 212 can also rotate relative to the main body support 10 in the axial direction by driving the curved section 2112 to deform to move closer to or away from the main body support 10. Thus, on the one hand, when the valve prosthesis 100 is loaded into the delivery device, the first clamping portion 212 can be tightly attached to the outer side wall of the main body support 10, thereby reducing the radial size of the valve prosthesis 100 to reduce the difficulty of sheathing the valve prosthesis 100. On the other hand, when the included angle between the native leaflet and the delivery device is large, the position between the first clamping portion 212 and the second clamping portion 222 and the delivery device can be adjusted to make the included angle between the first clamping portion 212 and the second clamping portion 222 and the delivery device compensate for the included angle between the native leaflet and the delivery device, so that the native leaflet can be better clamped to ensure that the length of the native leaflet clamped by the valve leaflet is sufficient to stably fix the valve prosthesis 100 on the native valve, that is, the angle position requirement of the delivery device and the native leaflet is reduced, and therefore, the delivery difficulty of the valve prosthesis 100 is reduced.

[0055] Please continue to refer to Figure 3 In an embodiment, the curved section 2112 is radially bent outward from the end connected to the straight rod section 2111 and then radially bent inward and connected to the first clamping portion 212. Thus, in the state that the valve leaflet clamp 20 is not subjected to external force or is subjected to insufficient external force to deform the valve leaflet clamp 20, the first clamping portion 212 can be as close to the main body support 10 as possible, and thus when the native leaflet is accommodated between the first clamping portion 212 and the main body support 10, the deformation of the curved section 2112 is greater, and therefore, the restoring force of the curved section 2112 applied to the first clamping portion 212 is greater, and thus the first clamping portion 212 can more tightly press the native leaflet against the main body support 10, that is, the clamping force and stability of the native leaflet are enhanced.

[0056] Please continue to refer to Figure 3 In an embodiment, the curved section 2112 is substantially in the shape of a "C" character, and the end of the curved section 2112 not connected to the straight rod section 2111 abuts against the straight rod section 2111, so that the first clamping portion 212 abuts against the outside of the main body support 10. The first clamping portion 212 can rotate by driving the "C" character-shaped opening of the curved section 2112 to be larger or smaller. In other embodiments, the curved section 2112 can also be arranged in the shape of "W" or "V" or other shapes to adapt to the deformation when the first clamping portion 212 rotates.

[0057] It can be understood that in other embodiments, the effect of adjusting the angle between the first clamping piece 21 and the second clamping piece 22 and the body support 10 can also be achieved by directly articulating the first connecting part 211 with the body support 10. Alternatively, in other embodiments, the curved section 2112 can be omitted, and the first clamping part 212 is directly connected with the straight rod section 2111, so that the first clamping part 212 cannot rotate in the axial direction.

[0058] Please refer to Figure 4 In an embodiment, the projection area of the first clamping part 212 on the body support 10 is larger than the projection area of the first connecting part 211 on the body support 10, so as to increase the contact area of the first clamping piece 21 with the native leaflet, and further increase the clamping stability of the valve leaflet clamp 20 to the native leaflet.

[0059] Please continue to refer to Figure 4 In an embodiment, the first clamping part 212 is a rectangular frame, and in other embodiments, the first clamping part 212 can also be provided as a circular frame or a triangular frame or other geometric shape of closed wire frame 2121. By providing the first clamping part 212 as a closed wire frame 2121, the deformation ability and adaptability of the first clamping part 212 itself can be increased on the premise that the contact area of the first clamping part 212 with the native leaflet is sufficient. In other embodiments, the first clamping part 212 can also be directly provided as a rectangular panel or a panel of other geometric shape.

[0060] In an embodiment, the hollowed-out position of the closed wire frame 2121 is also filled with a first film 2122, and the first film 2122 is used for cell crawling, so as to increase the firmness of the first clamping part 212 when clamping the native leaflet. The first film 2122 is made of a high polymer material.

[0061] Please continue to refer to Figure 4 In an embodiment, an anchor 2123 is also provided on the first clamping part 212, one end of the anchor 2123 is connected with the first clamping part 212, and the other end extends away from the first clamping part 212 to form a sharp end, and the anchor 2123 is used to hook on the native leaflet when the first clamping part 212 clamps the native leaflet, so as to increase the clamping stability of the valve leaflet clamp 20.

[0062] In an embodiment, the anchor 2123 is provided with two rows and is correspondingly provided on two axial extension edges of the rectangular frame. In an embodiment, the anchor 2123 can be integrally formed with the first clamping part 212, for example, the anchor 2123 and the first clamping part 212 are cut through a plate-shaped member and then heat set to form. In other embodiments, the anchor 2123 and the first clamping part 212 can also be connected by welding.

[0063] Please continue to refer to Figure 4 In an embodiment, the second connecting part 221 has a projection area on the main body support 10 larger than that of the second clamping part 222, so that the second connecting part 221 can collect as many native leaflets as possible, and provide a larger driving force for the second clamping part 222 to firmly press the native leaflets against the first clamping part 212, thereby further ensuring the clamping stability of the valve prosthesis 100.

[0064] Please continue to refer to Figure 4 and in combination with Figure 2 In an embodiment, one end of the second connecting part 221 is connected to the main body support 10, and the other end is connected to the second clamping part 222 after being radially bent.

[0065] In an embodiment, the second connecting part 221 and the second clamping part 222 are formed by a curved rod. Both free ends of the curved rod are connected to the main body support 10, and the connection points of the two free ends of the curved rod on the main body support 10 are separated by a certain distance. The middle section of the curved rod first extends in the axial direction of the main body support 10 away from the main body support 10 by a certain distance, then bends and folds radially outward, and then extends in the axial direction of the main body support 10 towards the main body support 10 to form the second connecting part 221 which has a tendency to conform to the main body support 10 in the circumferential direction. Then, the middle section of the curved rod gradually converges in the circumferential direction to form the second clamping part 222 which has a circumferential width matching that of the first clamping part 212, i.e., the second clamping part 22 has a generally "convex" structure. In this way, the second clamping part 22 can press and fix the collected native leaflets towards the side of the first clamping part 21.

[0066] Please refer to Figure 5In another embodiment, the second connecting part 221 is connected to the main body support 10 at one end and connected to the second clamping part 222 at the other end after being bent radially. However, unlike the previous embodiment, in this embodiment, the second clamping part 22 includes two curved rods forming the second connecting part 221 and a holding frame forming the second clamping part 222. The two curved rods are connected to the main body support 10 at one end, extend a certain distance away from the main body support 10 along the axial direction of the main body support 10, then fold and bend radially outward, and then extend towards the main body support 10 along the axial direction of the main body support 10 to be connected to the holding frame. The holding frame can be sleeved on the outside of the first clamping part 212 along the circumferential direction of the first clamping part 212, i.e., the circumferential width of the second clamping part 222 is greater than that of the first clamping part 212. In this way, the area of the second clamping part 222 overlaps with that of the first clamping part 212 as much as possible, thereby increasing the folding area of the native leaflets and further compressing the native leaflets. The native leaflets are folded in the gap between the outer peripheral edge of the first clamping part 212 and the inner wall of the holding frame of the second clamping part 222, thereby increasing the clamping force on the native leaflets and making them less likely to come off, thereby enhancing the clamping stability.

[0067] Please continue to refer to Figure 5 In an embodiment, a pulling hole 223 is provided at the end of the second clamping part 222 that is not connected to the second connecting part 221. The pulling hole 223 can be used to pass a pulling wire to drive the second clamping part 22 to rotate in the axial direction. By controlling the pulling wire, the angle between the second clamping part 22 and the main body support 10 can be adjusted, thereby adjusting the opening state of the second clamping part 22 so that the second clamping part 22 can collect as many native leaflets as possible.

[0068] Please continue to refer to Figure 5 In an embodiment, the second clamping part 222 is filled with a second film 2221 made of a high-molecular material that can be used for cell adhesion in the hollow part.

[0069] It should be noted that, in an embodiment, the leaflet structure includes three valve leaflets that can be opened or closed, and the valve leaflets are connected to the inner wall of the main body support 10. When the valve prosthesis 100 is implanted in the body, the three valve leaflets open and close (or close and open) with the diastole and systole of the heart, thereby closing or opening the lumen 101. The material of the leaflets can be biological material or high-molecular material. In other embodiments, the number of valve leaflets is not limited to three, for example, it can be two or four.

[0070] Any technical features in the above-described embodiments can be combined in any manner, and for the sake of brevity, not all possible combinations are described, but it is understood that the scope of the disclosure encompasses all possible combinations.

[0071] The above-described embodiments are merely preferred embodiments of the present application and are not intended to limit the scope of the present application, and equivalents of the technical features of the present application are intended to be included in the scope of the present application. Therefore, the scope of the present application should be determined by the following claims.

Claims

1. A valve prosthesis, characterized in that, The valve leaflet clip comprises a main body support and a valve leaflet clip, the main body support is provided with a lumen, the valve leaflet clip comprises: a first clamping piece, one end of which is connected with the main body support, and the other end extends along the axial direction of the main body support to form a free end; and a second clamping piece, one end of which is connected with the main body support, and the other end extends along the axial direction of the main body support to form a free end, the second clamping piece is located on the side of the first clamping piece away from the main body support in the radial direction, and the second clamping piece can rotate relative to the first clamping piece in the axial direction to approach or move away from the first clamping piece.

2. The valve prosthesis of claim 1, wherein, The first clamping piece comprises a first connecting part and a first clamping part, one end of the first connecting part is connected with the main body support, and the other end is bent radially and then connected with the first clamping part, the first clamping part extends axially from the end connected with the first connecting part to the direction away from the first connecting part, the second clamping piece comprises a second connecting part and a second clamping part, one end of the second connecting part is connected with the main body support, and the other end is bent radially and then connected with the second clamping part, the second clamping part extends axially from the end connected with the first connecting part to the direction away from the second connecting part, and when the second clamping part approaches the first clamping part, the second clamping part abuts against the first clamping part to clamp the native leaflet.

3. The valve prosthesis of claim 2, wherein, The first connecting part comprises a straight rod segment and a curved segment, one end of the straight rod segment is connected with the main body support, and the other end extends along the axial direction of the main body support, one end of the curved segment is connected with the end of the straight rod segment not connected with the main body support, and the other end is connected with the first clamping part, and the first clamping part can drive the curved segment to deform to rotate relative to the main body support in the axial direction to approach or move away from the main body support.

4. The valve prosthesis of claim 3, wherein, The curved segment is connected with the first clamping part after being bent radially outward and then radially inward from the end connected with the straight rod segment.

5. The valve prosthesis of claim 2, wherein, The projection area of the first clamping part on the main body support is greater than the projection area of the first connecting part on the main body support.

6. The valve prosthesis of claim 5, wherein, The first clamping part comprises a closed wire frame and a first film filled in the closed wire frame.

7. The valve prosthesis of claim 2, wherein, The projection area of the second connecting part on the main body support is smaller than the projection area of the second clamping part on the main body support.

8. The valve prosthesis of claim 2, wherein, The second clamping piece is formed by a curved rod, both free ends of the curved rod are connected with the main body support, the middle segment of the curved rod extends along the axial direction of the main body support and is contracted in the circumferential direction to form the second clamping part, and the circumferential width of the second clamping part matches the circumferential width of the first clamping part.

9. The valve prosthesis of claim 2, wherein, The second connecting part comprises two curved rods, and the second clamping part is an abutting frame with a circumferential width greater than that of the first clamping part, and both of the two curved rods have one end connected with the main body support and the other end connected with the abutting frame.

10. The valve prosthesis of claim 1, wherein, The main body support comprises a plurality of connected axial struts and circumferential struts, and the circumferential struts are connected end to end to form a plurality of wave-shaped rings arranged along the axial direction of the main body support.

11. The valve prosthesis according to any one of claims 1-10, characterized in that, The valve prosthesis further comprises a valve leaflet structure arranged on the main body support, and the valve leaflet structure is openable or closable to make the lumen open or closed.

Images