Interventional medical prosthesis

Abstract

The interventional medical prosthesis comprises a first tubular component, a valve leaflet structure, a second tubular component and a transition component, and the first tubular component is provided with a tube cavity with openings in the two ends; the valve leaflet structure is arranged on the first tubular component, and the valve leaflet structure can be opened or closed to enable the tube cavity to be in an opened or closed state; the second tubular component is arranged outside the first tubular component in a sleeving manner, and a cavity is formed between the outer wall of the first tubular component and the inner wall of the second tubular component; one end of the transition component is connected with the first tubular component, the other end of the transition component is connected with the second tubular component, the transition component is used for blocking the cavity so that blood can circulate from the tubular cavity, and a shrinking part is arranged on the transition component and can deform along with deformation of the second tubular component. The interventional medical prosthesis can better adapt to a natural valve structure.

Description

Technical Field

[0001] This invention relates to the technical field of medical devices, and more particularly to an interventional medical prosthesis. Background Technology

[0002] This section provides only background information relevant to this disclosure and is not necessarily prior art.

[0003] Heart valves are the valves located between the atria and ventricles, or between the ventricles and arteries. The human heart consists of four chambers and four heart valves. The four chambers are the left atrium, left ventricle, right atrium, and right ventricle. Each atrium is connected to one of the two ventricles, and each ventricle is connected to one of the two great arteries. The heart valves grow between the atria and ventricles, and between the ventricles and the great arteries. The four heart valves are called the mitral valve, tricuspid valve, aortic valve, and pulmonary valve. Heart valves act as one-way valves, ensuring unidirectional blood flow and playing a vital role in ensuring the normal functioning of the heart.

[0004] Heart valve disease is a common heart disease. It refers to one or more valve lesions caused by factors such as rheumatic fever, myxomatosis, degenerative changes, congenital malformations, and ischemic necrosis. These lesions cause narrowing or insufficiency of the valves, which in turn hinders normal blood flow, increases the burden on the heart, and leads to damage to heart function and heart failure.

[0005] Currently, there are two main surgical treatments for valvular heart disease: open-heart surgery and minimally invasive interventional surgery. Compared to open-heart surgery, which involves significant surgical trauma, high risks, and requires long-term and expensive rehabilitation, minimally invasive interventional surgery is widely accepted by patients due to its advantages of minimal trauma, fewer complications, and faster postoperative recovery. Minimally invasive surgery treats valvular heart disease by replacing the valve.

[0006] The unique anatomical structure of the mitral valve presents a significant challenge to the design of mitral valve replacement prostheses. Because the mitral valve annulus is not symmetrical or uniform in shape, but rather roughly exhibits a non-circular D-shape or kidney-like shape, designing a mitral valve replacement prosthesis that perfectly conforms to the annulus is extremely difficult. If the mitral valve replacement prosthesis does not perfectly fit the natural leaflets and / or annulus, leaving gaps, blood can flow back into the left atrium through these gaps, causing paravalvular leakage. In cases where the gaps are large, the mitral valve replacement prosthesis may even dislodge, leading to mitral valve replacement failure.

[0007] Therefore, designing a mitral valve replacement prosthesis that can better fit the contour of the mitral valve annulus is of great significance for the treatment of mitral stenosis or regurgitation. Summary of the Invention

[0008] Therefore, it is necessary to provide an interventional medical prosthesis that can better adapt to the structure of natural valves.

[0009] An interventional medical prosthesis, comprising:

[0010] The first tubular member has a cavity open at both ends;

[0011] A leaflet structure is provided on the first tubular member, and the leaflet structure can be opened or closed to make the lumen open or closed;

[0012] A second tubular member is fitted over the first tubular member, and a cavity is formed between the outer wall of the first tubular member and the inner wall of the second tubular member; and,

[0013] A transition member, one end of which is connected to the first tubular member and the other end of which is connected to the second tubular member, is used to seal the cavity to allow blood to flow through the lumen. The transition member is provided with a wrinkled portion, which can deform with the deformation of the second tubular member.

[0014] In one embodiment, the wrinkled portion includes a plurality of radially arranged folds; or, the wrinkled portion includes a plurality of annular folds surrounding the first tubular member.

[0015] In one embodiment, the first tubular member and the second tubular member are tangent, such that the first tubular member and the second tubular member are eccentrically positioned; or...

[0016] The first tubular member and the second tubular member are connected by a connector to make the first tubular member and the second tubular member eccentrically positioned; the connector is an elastic member, and its two ends are respectively connected to the first tubular member and the second tubular member; or, the connector includes an elastic segment and a rigid segment connected to the elastic segment, the end of the rigid segment away from the elastic segment is connected to the first tubular member or the second tubular member, and the end of the elastic segment away from the rigid segment is connected to the second tubular member or the first tubular member; or, the connector is a U-shaped rod or a V-shaped rod including two legs, and the two legs are respectively connected to the first tubular member and the second tubular member.

[0017] In one embodiment, the first tubular member includes a first support and a first skirt covering the first support, the second tubular member includes a second support and a second skirt covering the second support, one end of the transition member is connected to the first skirt and the other end is connected to the second skirt to seal the cavity.

[0018] In one embodiment, the transition member and the second skirt are an integral structure. After the second skirt covers the second support, one end extends radially to the first skirt and connects with the first skirt to form the transition member; or, the transition member and the first skirt are an integral structure. After the first skirt covers the first support, one end extends radially to the second skirt and connects with the second skirt to form the transition member; or, the transition member, the first skirt, and the second skirt are not integral structures, with one end of the transition member connected to the first skirt and the other end connected to the second skirt.

[0019] The transition member has the wrinkled portion, which includes a plurality of radially arranged and circumferentially distributed folds, and in its natural state, the transition member is in a relaxed state in the radial direction.

[0020] In one embodiment, the first stent includes a plurality of connected first axial struts and first circumferential struts, the plurality of first circumferential struts being connected end to end to form a plurality of wave-shaped rings arranged along the axial direction of the interventional medical prosthesis, the plurality of first axial struts being used to connect at least partially adjacent wave-shaped rings.

[0021] The second support includes a plurality of connected second axial struts and second circumferential struts. The plurality of second circumferential struts are connected end to end to form a plurality of wave-shaped rings arranged along the axial direction of the interventional medical prosthesis. The plurality of second axial struts are used to connect at least partially adjacent wave-shaped rings, and the second axial struts and the second circumferential struts cooperate to form a plurality of parallelograms.

[0022] In one embodiment, the last of the plurality of waveform loops is a non-continuous closed structure, thereby forming a gap, and the tail end of the first bracket is flush with the head end of the gap, or the tail end of the first bracket does not protrude from the gap.

[0023] In one embodiment, the plurality of wave rings includes a first wave ring, a second wave ring, and a third wave ring arranged sequentially from the head end to the tail end along the axial direction of the second bracket. The second bracket also includes reinforcing rods. The first wave ring and the second wave ring are connected by a plurality of second axial support columns and a plurality of the reinforcing rods. The third wave ring is directly connected to the second wave ring, and the third wave ring has missing portions to form the gap.

[0024] In one embodiment, barbs are provided on the second circumferential support of both the reinforcing rod and the third wave ring. In the non-notch area, the connection points of the two barbs on the two adjacent second circumferential support with the corresponding second circumferential support and the connection point of the barb on the adjacent reinforcing rod with the reinforcing rod are triangularly distributed.

[0025] In one embodiment, the interventional medical prosthesis further includes a skirt support, one end of which is connected to the second tubular member, and the other end of which extends radially away from the second tubular member. The skirt support includes a plurality of radially arranged support rods, one end of which is connected to the second tubular member, and the other end of which extends radially to form a free end. The free end includes a plurality of sequentially connected S-shaped rods.

[0026] In one embodiment, the skirt support further includes a plurality of connecting rods, one end of which is connected to the second tubular member and the other end of which is connected to the support rod. The connecting rods are in pairs, and the two connecting rods in the same pair are connected to the end of the same support rod away from the free end.

[0027] The interventional medical prosthesis provided in this embodiment of the invention has a leaflet structure mounted on a first tubular member. A second tubular member is fitted outside the first tubular member and forms a cavity between them. Therefore, the second tubular member only functions to fix the prosthesis to human tissue, while the first tubular member functions to fix the leaflet structure. When the interventional medical prosthesis is implanted into a non-uniformly circular natural valve structure, the second tubular member undergoes adaptive deformation under the compression of the natural valve structure due to the buffering effect of the cavity, while the first tubular member does not deform. The transition member connecting the first and second tubular members has a wrinkled portion, which is part of the second tubular member. The deformation of the components provides an adjustable amount of shrinkage. Therefore, the deformation of the second tubular component will not affect the first tubular component, so that the leaflet structure set on the first tubular component can continue to maintain a normal opening and closing state. That is, by setting the functions of fixing the interventional medical prosthesis to human tissue and fixing the leaflet structure to be realized by the second tubular component and the first tubular component respectively, and having a cavity and transition component between the second tubular component and the first tubular component that can act as a buffer, the normal opening and closing of the leaflet structure can be avoided due to the compression of the single-layer stent-type interventional medical prosthesis by the valve structure. Thus, it can better adapt to the natural valve structure. Attached Figure Description

[0028] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0029] in:

[0030] Figure 1 This is a schematic diagram of the structure of an interventional medical prosthesis according to an embodiment of the present invention;

[0031] Figure 2 This is a schematic diagram of the structure of an interventional medical prosthesis according to an embodiment of the present invention from another perspective;

[0032] Figure 3 This is a schematic diagram of the structure of a first tubular member according to an embodiment of the present invention;

[0033] Figure 4 This is a schematic diagram of the structure of the second tubular member according to an embodiment of the present invention;

[0034] Figure 5 This is a schematic diagram of the structure of an interventional medical prosthesis implanted at the mitral valve position according to an embodiment of the present invention. Detailed Implementation

[0035] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0036] In the description of the embodiments of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, are only for the convenience of describing the embodiments of the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the embodiments of the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0037] In the description of the embodiments of the present invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a replaceable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in the embodiments of the present invention based on the specific circumstances.

[0038] In the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally called the "proximal end," and the end that is farther from the operator is called the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device are defined. "Axial direction" generally refers to the length of the medical device during delivery, while "radial direction" generally refers to the direction of the medical device that is not parallel to its "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined. "Circumferential direction" refers to the circumferential direction, that is, the axial direction surrounding a tubular structure or cylinder.

[0039] Please see Figure 1 One embodiment of the present invention provides an interventional medical prosthesis 100 for implantation in the mitral valve to treat mitral valve disease. In other embodiments, it can also be implanted in the location of other valve structures such as the tricuspid valve, aortic valve, or pulmonary valve to treat valvular disease.

[0040] It should be noted that, for ease of discussion, in the embodiments below, the state of the interventional medical prosthesis 100 after implantation into the tissue is taken as the standard, and the blood inflow end of the interventional medical prosthesis 100 is defined as the head end and the blood outflow end of the interventional medical prosthesis 100 is defined as the tail end for discussion.

[0041] Please continue reading. Figure 1 and combined Figure 2 In one embodiment, the interventional medical prosthesis 100 includes a first tubular member 10, a second tubular member 20, and a leaflet structure 30 (see...). Figure 5 ) and transition component 40.

[0042] The first tubular member 10 has a lumen 1001 open at both ends. A leaflet structure 30 is disposed on the first tubular member 10, and the leaflet structure 30 can open or close, thereby allowing the lumen 1001 to be in an open or closed state. The second tubular member 20 is sleeved outside the first tubular member 10, and a cavity 1002 is formed between the outer wall of the first tubular member 10 and the inner wall of the second tubular member 20. A transition member 40 is connected at one end to the first tubular member 10 and at the other end to the second tubular member 20. The transition member 40 is used to seal the cavity 1002 to ensure blood flow from the lumen 1001. The transition member 40 is provided with a wrinkled part 401, which can adapt to the deformation of the second tubular member 20.

[0043] When the interventional medical prosthesis 100 is implanted into a non-uniformly circular valve structure such as the mitral valve, the second tubular member 20 undergoes adaptive deformation under the compression of the valve structure. Since there is a cavity 1002 between the second tubular member 20 and the first tubular member 10, the cavity 1002 acts as a buffer, allowing the first tubular member 10 to maintain its original unstressed shape without being compressed by the valve structure. At the same time, since the transition member 40 connecting the first tubular member 10 and the second tubular member 20 is provided with a wrinkled portion 401, the wrinkled portion 401 can adapt to the deformation of the second tubular member 20. Therefore, the deformation of the second tubular member 20 will not cause the first tubular member 10 to deform. This ensures that the first tubular member 10 can maintain its unstressed shape without being affected by the compression of the valve structure or the second tubular member 20, thereby ensuring that the leaflet structure 30 installed on the first tubular member 10 can open and close normally. That is, by setting the functions of fixing the interventional medical prosthesis 100 to human tissue and fixing the valve leaflet structure to be realized by the second tubular component 20 and the first tubular component 10 respectively, the interventional medical prosthesis 100 can adapt to the shape of the valve structure while ensuring the normal opening and closing of the valve leaflet structure 30, thereby avoiding paravalvular leakage and facilitating the application of the interventional medical prosthesis 100.

[0044] Please continue reading. Figure 1-2In one embodiment, the first tubular member 10 is tangent to the second tubular member 20, meaning that in the radial section (the section perpendicular to the longitudinal central axis of the first tubular member 10), the cross-sectional circle of the first tubular member 10 is the inscribed circle of the cross-sectional circle of the second tubular member 20, and the cross-sectional shape of the cavity 1002 is approximately crescent-shaped, thereby allowing the interventional medical prosthesis 100 to better adapt to the D-shaped structure of the mitral valve. In other embodiments, the first tubular member 10 and the second tubular member 20 may not be tangent, but rather the first tubular member 10 may be eccentrically positioned within the second tubular member 20, and the cross-sectional shape of the cavity 1002 may be non-uniformly annular, which can also better adapt to the D-shaped structure of the mitral valve. The first tubular member 10 and the second tubular member 20 are tangent to each other, so that the first tubular member 10 can be directly connected to the second tubular member 20 at the tangent point. This allows the first tubular member 10 to be kept in a relatively stable position with human tissue under the action of the second tubular member 20. The direct connection at the tangent point can be achieved by relatively simple and convenient methods such as welding, suturing or binding.

[0045] Please continue reading. Figure 1 In one embodiment, the first tubular member 10 includes a first support 11 and a first skirt 12, and the second tubular member 20 includes a second support 21 and a second skirt 22.

[0046] Both the first support 11 and the second support 21 are bare frame structures, serving as the main support. The first skirt 12 covers the first support 11, so that the first tubular member 10 is open at only two ends. The second skirt 22 covers the second support 21, so that the second tubular member 20 is open at only two ends. The first skirt 12 and the second skirt 22 can be made of polyethylene terephthalate or felt, and the materials are not limited to those mentioned above. Any flexible material that can block blood flow and is suitable for implantation in the human body can be selected.

[0047] Please refer to 1. In one embodiment, the first support 11 includes a plurality of first axial struts 101 and a plurality of first circumferential struts 102. The first axial struts 101 and the first circumferential struts 102 are interconnected so that the first support 11 can switch between a compressed state and an expanded state.

[0048] Please refer to the following: Figure 1 and Figure 3In one embodiment, multiple first circumferential support columns 102 are inclined and connected end-to-end to form multiple wave-shaped rings 1020 arranged along the axial direction of the first support 11. The multiple wave-shaped rings 1020 can be connected to each other through the first axial support columns 101 or directly connected. In other embodiments, the first circumferential support columns 102 may not be connected end-to-end. For example, the first circumferential support columns 102 are staggered and connected to the first axial support columns 101 to form wave-shaped rings 1020. It is understood that the number and arrangement of the first axial support columns 101 and the first circumferential support columns 102 are not limited, as long as the first support 11 formed by splicing can switch between a compressed state and an expanded state.

[0049] Please continue reading 1 and combine it with... Figure 3 In one embodiment, the first support 11 includes three wave rings 1020. For ease of description, the three wave rings 1020 on the first support 11 are respectively named the first wave ring 10201, the second wave ring 10202, and the third wave ring 10203, which are arranged sequentially from the head end to the tail end along the axial direction of the first support 11. The first wave ring 10201 and the second wave ring 10202 are axially connected by multiple first axial support columns 101, and the second wave ring 10202 and the third wave ring 10203 are also axially connected by multiple first axial support columns 101.

[0050] In a more specific embodiment, the peaks of the first waveform ring 10201, the second waveform ring 10202, and the third waveform ring 10203 are all aligned on the same axis and connected by the first axial support 101. The troughs of the three are also aligned on another axis, but there is no connection between the troughs of the three, thereby making the first support 11 more flexible.

[0051] In another more specific embodiment, among the plurality of first axial supports 101 connecting the first waveform ring 10201 and the second waveform ring 10202, at least one first axial support 101 connects the trough of the first waveform ring 10201 and the trough of the second waveform ring 10202. Of the remaining first axial supports 101, one end of each first axial support 101 is connected to the crest of the first waveform ring 10201, and the other end is connected to the crest of the second waveform ring 10202. Similarly, among the plurality of first axial supports 101 connecting the second waveform ring 10202 and the third waveform ring 10203, at least one first axial support 101 connects the trough of the second waveform ring 10202 and the trough of the third waveform ring 10203. Of the remaining first axial supports 101, one end of each first axial support 101 is connected to the crest of the second waveform ring 10202, and the other end is connected to the crest of the third waveform ring 10203. The first axial support 101 connecting the troughs of the first waveform ring 10201 and the second waveform ring 10202, and the first axial support 101 connecting the troughs of the second waveform ring 20202 and the third waveform ring 10203 are aligned axially. This arrangement can better balance the flexibility and support strength of the first support 11.

[0052] In other embodiments, the first waveform ring 10201, the second waveform ring 10202, and the third waveform ring 10203 may be connected by the first axial support 101 at the trough positions, while not directly connected at the crest positions. Alternatively, the first waveform ring 10201, the second waveform ring 10202, and the third waveform ring 10203 may be connected by the first axial support 101 at both the crest and trough positions, thereby improving the support of the first support 11.

[0053] Please continue reading. Figure 3 In one embodiment, the first support 11 further includes a fixing rod 103. One end of the fixing rod 103 is connected to the crest of the third waveform ring 10203, and the other end is a free end that extends axially away from the crest of the third waveform ring 10203. Furthermore, the end face of the free end of the fixing rod 103 is flush with the end face of the trough of the third waveform ring 10203. A fixing structure 1032 is provided on the fixing rod 103 near the free end for connection to the leaflet structure 30.

[0054] When the first support 11 is tangent to the second support 21, the first axial support 101 connecting the trough of the second waveform ring 10202 and the trough of the third waveform ring 10203 is located at the tangent point. That is, the first axial support 101 is not only used to connect the second waveform ring 10202 and the third waveform ring 10203, but also to provide a position for the connection between the first support 11 and the second support 21, thereby ensuring the symmetry of the first support 11 after molding.

[0055] In other embodiments, the number of waveform rings 1020 included in the first support 11 is not limited to 3, but can also be 4, 5 or 6 or other integers.

[0056] Please return Figure 1 In one embodiment, the second support 21 includes a plurality of second axial supports 201 and a plurality of second circumferential supports 202, the second axial supports 201 and the second circumferential supports 202 being interconnected so that the second support 21 can switch between a compressed state and an expanded state.

[0057] Multiple second-wave rings are inclined to the support column 202 and connected end to end, thereby forming multiple wave rings 2020 arranged along the axial direction of the second support 21. The multiple wave rings 2020 are connected to each other through the second axial support column 202. In one embodiment, the second support 21 includes three wave rings 2020. For ease of description, the three wave rings 2020 are respectively named as the first wave ring 20201, the second wave ring 20202, and the third wave ring 20203, which are arranged sequentially from the head end to the tail end along the axial direction of the second support 21.

[0058] In one embodiment, the crests of the first waveform ring 20201 and the crests of the second waveform ring 20202 are aligned on the same axis, and the troughs of the first waveform ring 20201 and the troughs of the second waveform ring 20202 are aligned on another axis. A second axial support 201 is disposed between the first waveform ring 20201 and the second waveform ring 20202. One end of the second axial support 201 is connected to the crest or trough of the first waveform ring 20201, and the other end extends axially to connect the crest or trough of the second waveform ring 20202, thereby connecting and fixing the first waveform ring 20201 and the second waveform ring 20202. When the second support 21 is in an expanded state, the second axial supports 201 divide the gap between the first waveform ring 20201 and the second waveform ring 20202 into multiple parallelograms. The crest of the third waveform ring 20203 and the trough of the second waveform ring 20202 are aligned on the same axis, and the crest of the third waveform ring 20203 and the trough of the second waveform ring 20202 are directly connected. The trough of the third waveform ring 20203 and the crest of the second waveform ring 20202 are aligned on the same axis and are separated by a certain distance. This arrangement of the first waveform ring 20201, the second waveform ring 20202, and the third waveform ring 20203 ensures that the second support 21 has both good deformability and good stability.

[0059] It is understood that in other embodiments, the shape, number, and arrangement of the waveform rings 2020 are not limited. For example, in other embodiments, the waveform units of the waveform rings 2020 can also be made to take on a sine wave shape or other shapes by changing the shape of the second circumferential support 202.

[0060] In other embodiments, the number of waveforms 2020 included in the second support 21 is not limited to 3, but can also be 4, 5 or 6 or other integers.

[0061] In other embodiments, the arrangement of the waveform rings 1020 on the first support 11 can be the same as the arrangement of the waveform rings 2020 on the second support 21, or the arrangement of the waveform rings 2020 on the second support 21 can also be the same as the arrangement of the waveform rings 1020 on the first support 11. Alternatively, in other embodiments, the crests of the first waveform ring 20201 and the troughs of the second waveform ring 20202 may be aligned and separated by a certain distance, while the troughs of the first waveform ring 20201 and the crests of the second waveform ring 20202 may be aligned and directly connected. The crests and troughs of the third waveform ring 20203 are aligned with the crests and troughs of the second waveform ring 20202, respectively, and are connected by the second axial support 201. Thus, when the second support 21 is in an expanded state, the first waveform ring 20201 and the second waveform ring 20202 cooperate to form several rhombuses. The several second axial supports 201 divide the distance between the second waveform ring 20202 and the third waveform ring 20203 into multiple parallelograms. In this way, the second support 21 can have good deformability and good stability.

[0062] Please continue reading. Figure 1 In one embodiment, the peaks of the first waveform loop 20201 and the peaks of the second waveform loop 20202 are aligned, and the troughs of the first waveform loop 20201 and the troughs of the second waveform loop 20202 are aligned.

[0063] The second support 21 also includes multiple reinforcing rods 203. The multiple reinforcing rods 203 and multiple second axial support columns 201 connect the first wave ring 20201 and the second wave ring 20202. Furthermore, the multiple reinforcing rods 203 and multiple second axial support columns 201 are alternately distributed in the circumferential direction. Each reinforcing rod 203 connects to the trough of the first wave ring 20201 and the trough of the second wave ring 20202, and each second axial support column 201 connects to the crest of the first wave ring 20201 and the crest of the second wave ring 20202. This arrangement forms a parallelogram with one second circumferential support column 202 of the first wave ring 20201, one second circumferential support column 202 of the second wave ring 20202 aligned axially with the second circumferential support column 202, adjacent second axial support columns 201, and reinforcing rods 203. This arrangement ensures that the second support 21 has good deformability while also having good stability.

[0064] It is understood that in other embodiments, each reinforcing rod 203 may be connected to the crest of the first waveform ring 20201 and the crest of the second waveform ring 20202, and each second axial support 201 may be connected to the trough of the first waveform ring 20201 and the trough of the second waveform ring 20202.

[0065] In one embodiment, the strength of the reinforcing rod 203 is greater than the support strength of the second axial support 201. In another embodiment, at least a portion of the circumferential width of the reinforcing rod 203 is greater than the circumferential width of the second axial support 201, thereby increasing the support strength of the reinforcing rod 203.

[0066] In one embodiment, each reinforcing rod 203 is provided with barbs 211, which can penetrate the tissue to assist in fixation when the second support 21 is implanted at the target position. Providing barbs 211 on the reinforcing rod 203 with high support strength facilitates the reliable penetration of the barbs 211 into the tissue, thereby facilitating the reliable anchoring of the second support 21 to the target site.

[0067] In one embodiment, a first axial strut 101 on the first support 11 and a second axial strut 201 on the second support 21 are radially aligned and secured by sutures, thereby making the first support 11 and the second support 21 tangentially positioned. The sutures can be made of polymer materials such as polyester, polypropylene, and polytetrafluoroethylene; the sutures are not limited to the materials mentioned above, and any material suitable for implantation in the human body can be selected. In other embodiments, the first axial strut 101 and the second axial strut 201 can also be connected by welding or other methods.

[0068] It is understood that in other embodiments, the first support 11 and the second support 21 are connected by other structures, for example, the first support 11 and the second support 21 are eccentrically connected by a connector. In one embodiment, the connector is an elastic member, with its two ends connected to the first support 11 and the second support 21 respectively, so that the first support 11 is fixed in the second support 21 in an eccentric but not tangential manner. At the same time, when the connection between the second support 21 and the first support 11 is compressed, the elastic member can deform accordingly, thereby adapting to the natural valve anatomy and protecting the leaflet structure 30.

[0069] In one embodiment, the connector includes a rigid segment and an elastic segment connected to the rigid segment. One end of the rigid segment away from the elastic segment and the other end of the elastic segment away from the rigid segment are connected to the first support 11 or the second support 21, and the other end is connected to the second support 21 or the first support 11. This allows the first support 11 to be fixed inside the second support 21 in an eccentric but not tangential manner. At the same time, when the connection between the second support 21 and the first support 11 is compressed, the elastic segment can deform accordingly. The presence of the rigid segment can further help prevent the second support 21 from compressing the first support 11, thereby adapting to the natural valve anatomy and protecting the leaflet structure 30.

[0070] In other embodiments, the connector is a U-shaped rod or a V-shaped rod with two legs, such that one leg of the U-shaped rod or V-shaped rod is connected to the first support 11 and the other leg is connected to the second support 21, thereby fixing the first support 11 in the second support 21 in an eccentric but not tangential manner, thereby adapting to the natural valve anatomy and protecting the leaflet structure 30.

[0071] Please continue reading. Figure 1In one embodiment, the third waveform loop 20203 is an incomplete waveform, meaning it has a missing portion (the missing portion being the second circumferential strut 202) and is a discontinuous closed structure. This results in a notch on the second stent 21, and the tail end of the first stent 11 is flush with the head end of the notch, or the tail end of the first stent 11 does not protrude from the notch, meaning the first stent 11 and the notch do not overlap axially. When the interventional medical prosthesis 100 is implanted onto the mitral valve, placing this notch at the position of the anterior leaflet of the mitral valve can prevent the presence of the first stent 11 and the second stent 21 from obstructing the smooth flow of blood from the left ventricle along the aorta. It is understood that the size and position of the notch are not limited. In other embodiments, the notch can be set according to the blood flow conditions at the implantation target location. When the first stent 11 and the second stent 21 do not affect the blood flow near the target location, the notch can also be omitted. In other embodiments, the tail end of the first stent 11 may not be flush with the head end of the notch, but may extend beyond the head end of the notch. In this case, the interventional medical prosthesis 100 can still achieve the effect of not affecting the blood flow from the left ventricle along the aorta. However, the notch avoidance effect is best when the tail end of the first stent 11 is flush with the head end of the notch.

[0072] In one embodiment, the tail end of the first stent 11 is flush with the head end of the notch in the second stent 21. The leaflet structure 30 is fixed to the first stent 11 by the fixing structure 1032 of the fixing rod 103, so that the tail end of the leaflet structure 30 does not protrude from the notch. Furthermore, the head end face of the first stent 11 protrudes from the head end face of the second stent 21, that is, the first stent 11 protrudes from the end of the second stent 21 away from the notch. Thus, the connection between the leaflet structure 30 and the first stent 11 does not obstruct the smooth flow of blood from the left ventricle along the aorta, and the first stent 11 has sufficient length to not affect the opening and closing of the leaflet structure 30.

[0073] In one embodiment, the third waveform ring 20203 is a discontinuous closed structure with gaps formed by connecting multiple second circumferential support columns 202. Furthermore, the crest of the third waveform ring 20203 is directly connected to the second waveform ring 20202. The direct connection between the third waveform ring 20203 and the second waveform ring 20202 complements the connection between the first waveform ring 20201 and the second waveform ring 20202 through the second axial support column 202 and the reinforcing rod 203, so that the second support 21 has sufficient length, flexibility and support strength.

[0074] In one embodiment, each of the second circumferential support pillars 202 forming the third wave ring 20203 is also provided with barbs 211. In the non-notch areas, the two barbs 211 on two adjacent second circumferential support pillars 202 and their corresponding two connection points, as well as one barb 211 on an adjacent reinforcing rod 203 and its connection point to the reinforcing rod 203, are arranged in a triangular pattern, such as... Figure 4 As indicated by the markings in the central circular region IV, this helps to improve the anchoring performance of the second stent 21, thereby improving the positional stability of the implanted interventional medical prosthesis 100 and enhancing its safety and reliability.

[0075] In one embodiment, the first support 11 and the second support 21 are formed by cutting tubular components. In other embodiments, the first support 11 may also be formed by splicing a first axial support 101 and a first circumferential support 102 and then welding them together. The second support 21 may also be formed by splicing a second axial support 201 and a second circumferential support 202 and then welding them together. The first support 11 and the second support 21 may be made of nickel-titanium alloy, thereby giving them self-expanding properties. In other embodiments, the first support 11 and the second support 21 may also be made of metal materials such as cobalt-chromium alloy or stainless steel. In this case, the first support 11 and the second support 21 can switch from a compressed state to an expanded state by balloon expansion. It is understood that regardless of the method or material used to form the first support 11 and the second support 21, they all possess the property of being able to switch between a compressed state and an expanded state.

[0076] In one embodiment, the barb 211 and the second support 21 are shaped together after cutting the tubular component. In other embodiments, the barb 211 can also be connected to the second support 21 by welding.

[0077] Referring to 1-2, in one embodiment, the interventional medical prosthesis 100 further includes a skirt support 50. One end of the skirt support 50 is connected to the head end of the second tubular member 20, and the other end extends radially away from the second tubular member 20. In one embodiment, the skirt support 50 is connected to the end of the first waveform coil 20201 away from the second waveform coil 20202. The skirt support 50 is used to overlap tissue when the interventional medical prosthesis 100 is implanted at the valvular lesion site, thereby assisting in the fixation of the interventional medical prosthesis 100. For example, when the interventional medical prosthesis 100 is implanted at the mitral valve site, the skirt support 50 overlaps the atrial tissue side of the mitral valve annulus, thereby cooperating with the barbs 211 to fix the valve prosthesis 100.

[0078] Please continue reading. Figure 2In one embodiment, the skirt support 50 includes a plurality of radially arranged support rods 510. One end of each support rod 510 is connected to the second tubular member 20, and the other end extends radially along the second tubular member 20 to form a free end.

[0079] In one embodiment, the free end of the support rod 510 is formed by connecting multiple S-shaped rods to make the free end of the support rod 510 generally wavy. This design allows the support rod 510 to have better flexibility. During blood flow impact, the flexibility of the free end can act as a buffer, thereby reducing the pressure of the support rod 510 on the atrial tissue and improving the compliance of the free end of the support rod 510.

[0080] Please continue reading. Figure 2 In one embodiment, the skirt support 50 further includes a plurality of connecting rods 520. One end of the connecting rod 520 is connected to the second tubular member 20, and the other end is connected to the support rod 510. The connecting rod 520 is used to connect the second tubular member 20 and the support rod 510, and in use, it can increase the contact area between the skirt support 50 and the tissue, which is beneficial to improving the anchoring performance of the interventional medical prosthesis 100.

[0081] In one embodiment, the end of the connecting rod 520 connected to the second tubular member 20 is connected to the crest of the first waveform coil 20201, and the connecting rods 520 are in pairs. The two connecting rods 520 in the same group are connected to the same support rod 510, so that the two connecting rods 520 form a "V-shaped structure". This increases the contact area between the skirt support 50 and the tissue while ensuring the compliance of the skirt support 50, ensuring the stability of the skirt support 50 when it contacts the tissue, and improving the anchoring performance of the interventional medical prosthesis 100.

[0082] In one embodiment, the skirt support 50 further includes a skirt 530. The skirt 530 is annular, with one end connected to the second support 21 and the other end extending radially away from the outer surface of the second support 21. Furthermore, the support rod 510 and the connecting rod 520 are both connected to the skirt 530, so that the skirt support 50 remains perpendicular or substantially perpendicular to the longitudinal central axis of the second support 21, thereby providing a more stable fit on the tissue.

[0083] In one embodiment, the support rod 510 and the connecting rod 520 are disposed on the side of the skirt 530 axially away from the second support 21. Alternatively, the support rod 510 and the connecting rod 520 are enclosed within the skirt 530. This arrangement of the skirt 530 serves two purposes: firstly, it provides flow obstruction, which helps prevent paravalvular leakage; secondly, during use, the skirt 530 directly contacts the tissue, preventing the support rod 510 and the connecting rod 520 from directly contacting and damaging the tissue.

[0084] Please see Figure 5 In one embodiment, the leaflet structure 30 includes three openable or closable leaflets connected to the inner wall of the first tubular member 10. When the interventional medical prosthesis 100 is implanted in the body, the three leaflets close and open (or open and close) with the diastole and systole of the heart, thereby causing the lumen 1001 to close or open. The leaflets can be made of biomaterials or polymer materials. In other embodiments, the number of leaflets is not limited to three; for example, it can be two or four.

[0085] Please return Figure 1 and Figure 2 In one embodiment, one end of the transition member 40 is connected to the first skirt 12 and the other end is connected to the second skirt 22, thereby achieving connection with the first tubular member 10 and the second tubular member 20 and sealing the cavity 1002.

[0086] In one embodiment, one end of the transition member 40 is connected to the tail end of the second tubular member 20, and the other end extends radially and connects to the tail end of the first tubular member 10. When the interventional medical prosthesis 100 is in its initial state, i.e., when the second tubular member 20 has not undergone compression deformation, the wrinkled portion 401 includes a plurality of annular folds radially distributed around the first tubular member 10. Please refer to... Figure 5 When the interventional medical prosthesis 100 is implanted into the mitral valve, the second tubular member 20 is deformed by the compression of the mitral valve to conform to the shape of the mitral valve annulus. Under the buffering effect of the cavity 1002, the first tubular member 10 is not compressed and maintains its original cylindrical shape. At this time, the transition member 40 undergoes adaptive deformation synchronously with the deformation of the second tubular member 20. By adjusting the amount of shrinkage of the annular folds of the shrinkage part 401, the shape of the implanted first tubular member 10 and the second tubular member 20 is matched. That is, the shrinkage part 401 also plays a buffering role, avoiding the situation where the deformation of the second tubular member 20 causes the first tubular member 10 to deform.

[0087] Understandably, in one embodiment, the transition member 40 can be connected to the first skirt 12 and the second skirt 22 via stitching. The transition member 40 can be formed from a circular skirt fabric with spaced-apart annular pleats. The skirt fabric can be partially pinched together to form a roughly crescent shape before being connected to the first skirt 12 and the second skirt 22, thereby adapting to the cross-sectional shape of the cavity 1002 before deformation. In other embodiments, the transition member 40 can also be directly formed from a roughly crescent-shaped skirt fabric. In other embodiments, the transition member 40 can also be an integral structure with the second skirt 22. After the second skirt 22 covers the second support 21, one end extends radially to the first skirt 12 and connects with the first skirt 12 to form the transition member 40. In another embodiment, the transition member 40 can also be an integral structure with the first skirt 12. After the first skirt 12 covers the first support 11, one end extends radially to the second skirt 22 and connects with the second skirt 22 to form the transition member 40.

[0088] It should be noted that the transition member 40 can be connected to the first skirt 12 and the second skirt 22 by sewing.

[0089] Regardless of whether the transition member 40 is an integral structure with the first skirt 12 or the second skirt 22, in one embodiment, when the transition member 40 is made of a flexible material, the wrinkled portion 401 includes a plurality of radially arranged and circumferentially distributed wrinkles, and in its natural state, the transition member 40 is in a relaxed state in the radial direction to accommodate the deformation of the second tubular member 20.

[0090] In another embodiment, the transition member 40 includes a plurality of annular folds surrounding the first tubular member 10, which are similar to the corrugated structure of a bellows, but unlike the corrugations of a bellows, the plurality of annular folds are distributed radially rather than axially.

[0091] It is also understood that in other embodiments, the transition member 40 may be connected to the head ends of the first tubular member 10 and the second tubular member 20 respectively; or, the transition member 40 may be connected at one end to the head end of the first tubular member 10 and at the other end to the tail end of the second tubular member 20; or, one end of the transition member 40 may be connected to the tail end of the first tubular member 10 and at the other end to the head end of the second tubular member 20. That is, the connection method between the transition member 40 and the first tubular member 10 and the second tubular member 20 is not limited. The transition member 40 only needs to provide the amount of shrinkage required for the deformation of the interventional medical prosthesis 100 and prevent blood flow from the cavity 1002.

[0092] In one embodiment, the transition member 40 can be made of polyethylene terephthalate or felt. The transition member 40 can be made of a flexible material that can be implanted in the human body and can block blood flow. That is, the material of the transition member 40 itself is not limited; the transition member 40 only needs to provide the amount of shrinkage required for the deformation of the interventional medical prosthesis 100 and prevent blood from flowing out of the cavity 1002.

[0093] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0094] The above description discloses only preferred embodiments of the present invention and should not be construed as limiting the scope of the present invention. Therefore, equivalent variations made in accordance with the claims of the present invention are still within the scope of the present invention.

Claims

1. An interventional medical prosthesis, characterized in that, include: The first tubular member has a cavity open at both ends; A leaflet structure is provided on the first tubular member, and the leaflet structure can be opened or closed to make the lumen open or closed; A second tubular member is fitted over the first tubular member, and a cavity is formed between the outer wall of the first tubular member and the inner wall of the second tubular member; and, A transition member, one end of which is connected to the first tubular member and the other end of which is connected to the second tubular member, is used to seal the cavity to allow blood to flow through the lumen. The transition member is provided with a wrinkled portion, which can deform with the deformation of the second tubular member.

2. The interventional medical prosthesis according to claim 1, characterized in that, The wrinkled portion includes a plurality of radially arranged folds; or, the wrinkled portion includes a plurality of annular folds surrounding the first tubular member.

3. The interventional medical prosthesis according to claim 1 or 2, characterized in that, The first tubular member is tangent to the second tubular member, such that the first tubular member and the second tubular member are eccentrically positioned; or, The first tubular member and the second tubular member are connected by a connector to make the first tubular member and the second tubular member eccentrically positioned; the connector is an elastic member, and its two ends are respectively connected to the first tubular member and the second tubular member; or, the connector includes an elastic segment and a rigid segment connected to the elastic segment, the end of the rigid segment away from the elastic segment is connected to the first tubular member or the second tubular member, and the end of the elastic segment away from the rigid segment is connected to the second tubular member or the first tubular member; or, the connector is a U-shaped rod or a V-shaped rod including two legs, and the two legs are respectively connected to the first tubular member and the second tubular member.

4. The interventional medical prosthesis according to claim 1, characterized in that, The first tubular member includes a first support and a first skirt covering the first support, the second tubular member includes a second support and a second skirt covering the second support, one end of the transition member is connected to the first skirt and the other end is connected to the second skirt to seal the cavity.

5. The interventional medical prosthesis according to claim 4, characterized in that, The transition member and the second skirt are integrally formed. After the second skirt covers the second support, one end extends radially to the first skirt and connects with the first skirt to form the transition member; or, the transition member and the first skirt are integrally formed. After the first skirt covers the first support, one end extends radially to the second skirt and connects with the second skirt to form the transition member; or, the transition member, the first skirt, and the second skirt are not integrally formed. One end of the transition member is connected to the first skirt, and the other end is connected to the second skirt. The transition member has the wrinkled portion, which includes a plurality of radially arranged and circumferentially distributed folds, and in its natural state, the transition member is in a relaxed state in the radial direction.

6. The interventional medical prosthesis according to claim 4, characterized in that, The first stent includes a plurality of connected first axial struts and first circumferential struts. The plurality of first circumferential struts are connected end to end to form a plurality of wave-shaped rings arranged along the axial direction of the interventional medical prosthesis. The plurality of first axial struts are used to connect at least partially adjacent wave-shaped rings. The second support includes a plurality of connected second axial struts and second circumferential struts. The plurality of second circumferential struts are connected end to end to form a plurality of wave-shaped rings arranged along the axial direction of the interventional medical prosthesis. The plurality of second axial struts are used to connect at least partially adjacent wave-shaped rings, and the second axial struts and the second circumferential struts cooperate to form a plurality of parallelograms.

7. The interventional medical prosthesis according to claim 6, characterized in that, Among the plurality of waveform loops, the waveform loop at the very end is a non-continuous closed structure, thereby forming a gap. The tail end of the first bracket is flush with the head end of the gap, or the tail end of the first bracket does not protrude from the gap.

8. The interventional medical prosthesis according to claim 7, characterized in that, The plurality of wave rings include a first wave ring, a second wave ring, and a third wave ring arranged sequentially from the head end to the tail end along the axial direction of the second bracket. The second bracket also includes reinforcing rods. The first wave ring and the second wave ring are connected by a plurality of second axial support columns and a plurality of the reinforcing rods. The third wave ring is directly connected to the second wave ring, and the third wave ring has missing portions to form the notch.

9. The interventional medical prosthesis according to claim 8, characterized in that, Both the reinforcing rod and the second circumferential support of the third wave ring are provided with barbs. In the non-notch area, the connection points of the two barbs on the two adjacent second circumferential supports and the corresponding second circumferential support, as well as the connection points of the barbs on the adjacent reinforcing rod and the reinforcing rod, are triangularly distributed.

10. The interventional medical prosthesis according to claim 1 or 2, characterized in that, The interventional medical prosthesis also includes a skirt support, one end of which is connected to the second tubular member, and the other end extends radially away from the second tubular member. The skirt support includes a plurality of radially arranged support rods, one end of which is connected to the second tubular member, and the other end extends radially to form a free end. The free end includes a plurality of sequentially connected S-shaped rods.

11. The interventional medical prosthesis according to claim 10, characterized in that, The skirt support also includes several connecting rods. One end of each connecting rod is connected to the second tubular component, and the other end is connected to the support rod. The connecting rods are in pairs, and the two connecting rods in the same pair are connected to the end of the same support rod away from the free end.

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