Prosthetic heart valve

Abstract

The utility model provides an artificial heart valve which comprises a support, valve leaflets, a strip and a connecting line, the valve leaflets are contained in the support, the number of the valve leaflets is at least two, the valve leaflets are distributed in a central symmetry mode in the circumferential direction of the inner surface of the support, the strip is connected to the valve leaflets, and the connecting line is connected to the connecting line. The strip is connected with the bracket through the connecting line; or the strip is connected to the support, and the strip is connected with the valve leaflet through the connecting line. The heart valve prosthesis can solve the problem that in the prior art, valve leaflet durability is poor, valve leaflet stress is reduced, and the service life of the heart valve prosthesis is prolonged.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to an artificial heart valve. Background Technology

[0002] The heart has four chambers: the left atrium and left ventricle are located on the left side of the heart, and the right atrium and right ventricle are located on the right side. The atria and ventricles form the ventricular inflow tract, the left ventricle and aorta form the left ventricular outflow tract, and the right ventricle and pulmonary artery form the right ventricular outflow tract. At the ventricular inflow and outflow tracts are valves that function as one-way valves, ensuring normal blood flow within the heart chambers. When these valves malfunction, cardiac hemodynamics change, leading to abnormal cardiac function, a condition known as valvular heart disease.

[0003] Transcatheter valve replacement surgery offers advantages such as no need for open-chest surgery, minimal trauma, and rapid patient recovery. Therefore, an increasing number of surgeries are performed via transcatheter valves, making artificial heart valves an important medical device for treating valvular heart disease. Leaflet durability is a crucial issue in heart valve technology, referring to the ability of the leaflets to maintain their structure and function over long-term use. However, current artificial heart valves connect the leaflets to the stent directly with sutures. When the artificial heart valve operates within the heart chambers, the leaflets are prone to stress under the impact of blood flow pressure, leading to leaflet failure. Furthermore, pinhole damage caused by the direct connection between the stent and valve via sutures also reduces the valve's lifespan. For younger patients, who cannot maintain long-term cardiac function with artificial heart valves, this increases the risks and costs of subsequent treatments. Utility Model Content

[0004] In view of this, the purpose of this utility model is to provide an artificial heart valve that can solve the problem of poor leaflet durability in the prior art, reduce leaflet stress, and improve the service life of the artificial heart valve.

[0005] This invention provides an artificial heart valve, comprising a stent, leaflets, strips, and connecting wires. The leaflets are housed within the stent, and at least two leaflets are provided, symmetrically distributed along the circumferential direction of the inner surface of the stent. The strips are connected to the leaflets, and the strips are connected to the stent via the connecting wires; or the strips are connected to the stent, and the strips are connected to the leaflets via the connecting wires.

[0006] In one embodiment, the leaflet includes a leaflet connecting portion and a leaflet arc portion that are fixedly connected in sequence. The strip includes a connecting strip and an arc strip. The connecting strip is fixedly connected between the leaflet connecting portion and the support. The arc strip is fixedly connected between the leaflet arc portion and the support. The arc strip is arranged along the arcuate direction of the leaflet arc portion.

[0007] In one embodiment, the leaflet includes a first surface and a second surface disposed opposite to each other, and the arcuate portion of the leaflet includes a starting region and an ending region disposed at intervals; the arcuate strip starts from the starting region and passes through the first surface to the second surface and from the second surface to the first surface at intervals of a first distance, and so on, interlacing until the ending region.

[0008] In one embodiment, when there is one arc strip, the arc strip is continuously intersected by the arc portion of the leaflet; or when there are at least two arc strips, each arc strip is intersected by the arc portion of the leaflet at a predetermined interval.

[0009] In one embodiment, the leaflet includes a first surface and a second surface disposed opposite to each other, and the arcuate portion of the leaflet includes a starting region and an ending region disposed at intervals; the arcuate strip starts from the starting region, passes through the first surface to the second surface and from the second surface to the first surface at intervals of a first distance, and repeats this process to the ending region, and then starts from the ending region, passes through the first surface to the second surface and from the second surface to the first surface at intervals of a second distance, and repeats this process to the starting region.

[0010] In one embodiment, the arcuate strip includes a first strip and a second strip, the leaflet includes a first surface and a second surface disposed opposite to each other, and the arcuate portion of the leaflet includes a starting region and an ending region disposed at intervals. The first strip starts from the starting region and passes through the first surface to the second surface and back to the first surface at intervals of a first distance, repeating this process until it reaches the ending region. The second strip starts from the ending region and passes through the first surface to the second surface and back to the first surface at intervals of a second distance, repeating this process until it reaches the starting region. Alternatively, the first strip and the second strip start from the starting region and pass through the first surface to the second surface and back to the first surface at intervals of a first distance, repeating this process until they reach the ending region. The first strip and the second strip are disposed parallel to each other.

[0011] In one embodiment, the bracket includes a first end and a second end disposed opposite to each other, and the arcuate strip is fixedly connected to the bracket in a spiral winding manner along the first end toward the direction of the second end.

[0012] In one embodiment, when there is one arc strip, the arc strip is continuously wrapped around the bracket; or when there are at least two arc strips, each arc strip is wrapped around the petal arc portion at a predetermined interval.

[0013] In one embodiment, the bracket includes a first end and a second end disposed opposite to each other. Along the first end toward the direction closer to the second end, the arcuate strip is spirally wound clockwise around the bracket from the first end to the second end, and then along the second end toward the direction closer to the first end, the arcuate strip is spirally wound counterclockwise around the bracket from the second end to the first end.

[0014] In one embodiment, the arcuate strip includes a third strip and a fourth strip, and the bracket includes a first end and a second end disposed opposite to each other. Along the first end toward the direction closer to the second end, the third strip is spirally wound clockwise around the bracket from the first end to the second end, and along the second end toward the direction closer to the first end, the fourth strip is spirally wound counterclockwise around the bracket from the second end to the first end; or the third strip and the fourth strip are disposed parallel to each other, and the third strip and the fourth strip are respectively spirally wound clockwise around the bracket along the first end toward the direction closer to the second end.

[0015] In one embodiment, the leaflet junction is formed by the leaflet protruding in a direction away from the leaflet midline, and the junction strip is spirally wound along the length direction of the leaflet junction.

[0016] In one embodiment, the leaflet junctions of two adjacent leaflets are connected by a junction strip; or the leaflet junctions of two adjacent leaflets are connected by each junction strip.

[0017] In one embodiment, the leaflet further includes a leaflet free edge, and after the strip is connected to the support, an L-shape is formed between the leaflet free edge and the leaflet connecting portion.

[0018] In one embodiment, when the bracket is a skirted bracket, the skirted bracket includes a bracket body and a skirt connected to the bracket body, and the strip and the skirt are connected by the connecting line; or when the bracket is a skirtless bracket, the strip and the skirtless bracket are connected by the connecting line.

[0019] In one embodiment, the strip is elastic and has an elongation of less than 50%.

[0020] The artificial heart valve of this invention uses a strip fixedly connected to the leaflet, and then uses a connecting wire to connect the strip to the stent, or the strip is fixedly connected to the stent and then uses a connecting wire to connect the strip to the leaflet; using the strip as an intermediate medium connecting the stent and the leaflet ensures that there is no direct connection between the leaflet and the stent, so that when the artificial heart valve works in the human heart chamber, it can increase the buffering force of the leaflet, reduce the stress on the leaflet, and extend the service life of the artificial heart valve. Attached Figure Description

[0021] To more clearly illustrate the technical solutions of the embodiments of this utility model, the drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this utility model and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0022] Figure 1 This is a schematic diagram of the structure of the artificial heart valve of this utility model.

[0023] Figure 2 This is a schematic diagram of the structure of the artificial heart valve of this invention under blood flow pressure.

[0024] Figure 3 This is a schematic diagram of the structure of the leaflet in the first embodiment of this utility model.

[0025] Figure 4 This is a side view of the structure of the first embodiment of the present invention when the petal arc portion, the arc strip and the support are connected.

[0026] Figure 5 This is a schematic diagram of the structure of the first embodiment of the present invention when the arc strip is knotted multiple times to fix the petals.

[0027] Figure 6 This is a side view of the structure of the leaflet fusion portion, fusion strip, and support connected according to the first embodiment of this utility model.

[0028] Figure 7 This is a top view schematic diagram of the artificial heart valve of this utility model.

[0029] Figure 8 yes Figure 7 A side view of the commissural section at point A.

[0030] Figure 9 This is a side view of the structure of the second embodiment of the present invention when the arc strip is connected to the arc portion of the leaflet and then connected to the support.

[0031] Figure 10 This is a side view of the structure of the third embodiment of the present invention when the arc strip is connected to the arc portion of the leaflet and then connected to the support.

[0032] Figure 11 This is a side view of the structure of the fourth embodiment of the present invention when the arc strip is connected to the arc portion of the leaflet and then connected to the support.

[0033] Figure 12 This is a side view of the fifth embodiment of the present invention, showing the connection between the arc strip fixed to the arc portion of the rear leaflet of the bracket.

[0034] Figure 13 This is a side view of the fifth embodiment of the present invention, showing the arc strip fixed to the bracket and connected to the arc portion of the leaflet via the first suture line.

[0035] Figure 14 This is a side view of the fifth embodiment of the present invention, showing the arc strip fixed to the bracket in circles and connected to the arc portion of the leaflet through the first suture line.

[0036] Explanation of reference numerals: Starting area - 101; Ending area - 102; Support - 11; First end - 111; Second end - 112; Leaflet - 12; First surface - 12a; Second surface - 12b; Leaflet fusion portion - 121; Leaflet arc portion - 122; Leaflet free edge - 123; Strip - 13; Connecting strip - 131; Arc strip - 132; First strip - 1321; Second strip - 1322; Connecting line - 14; First suture - 141; Second suture - 142.

[0037] The realization of the purpose, functional features and advantages of this utility model will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation

[0038] The specific embodiments of this utility model will now be described in detail with reference to the accompanying drawings. Obviously, the described embodiments are merely some, not all, of the embodiments of this utility model. Based on the description of this utility model, all other embodiments obtained by those skilled in the art without inventive effort are within the scope of protection of this utility model.

[0039] In the description of this utility model, unless otherwise explicitly specified and limited, the terms "set," "install," and "connect," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms according to the specific circumstances.

[0040] The terms “upper,” “lower,” “left,” “right,” “front,” “back,” “top,” “bottom,” “inner,” and “outer,” etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product is in use. They are used only for the convenience of description and simplification, 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. Therefore, they should not be construed as limitations on this utility model.

[0041] The terms “first,” “second,” “third,” etc., are used merely to distinguish elements with similar properties, not to indicate or imply relative importance or a specific order.

[0042] The terms “include,” “comprising,” or any other variation thereof are intended to cover non-exclusive inclusion, which includes not only the elements listed but also other elements not expressly listed.

[0043] As described herein, when referring to the heart valve stent or stent, "proximal" refers to the side of the heart valve stent in its extended state that is located on the delivery device or in the direction of the user-operated end. Correspondingly, "distal" refers to the side of the heart valve stent in its extended state that is away from the delivery device or in the direction of the user-operated end. In this application, when describing the heart valve stent, "proximal" refers to the side of the heart valve stent in its extended state that is closer to the apex of the heart. Correspondingly, "distal" refers to the side of the heart valve stent in its extended state that is away from the apex of the heart. Because the heart valve stent described herein is delivered via catheter through the aorta, "distal" and "proximal" refer to the same location, and "proximal" and "distal" refer to the same location. However, this does not preclude implantation via the apex of the heart; this description simply uses the example of the heart valve stent being delivered via catheter through the aorta.

[0044] First Embodiment

[0045] like Figures 1 to 8As shown, the artificial heart valve includes a stent 11, leaflets 12, strips 13, and connecting wires 14. The leaflets 12 are housed within the stent 11. The leaflets 12 have at least two leaflets and are symmetrically distributed along the circumferential direction of the inner surface of the stent 11. The strips 13 are connected to the leaflets 12, and the strips 13 are connected to the stent 11 via the connecting wires 14. In this embodiment, when the leaflets 12 of the artificial heart valve are in the closed state, adjacent leaflets 12 are tightly closed or joined together in a sealing manner. The leaflets 12 can be made of biological tissue materials, such as chemically stable tissue from animal heart valves, such as porcine heart valves, or animal pericardial tissue, preferably bovine pericardial tissue, but also sheep pericardium, porcine pericardium, or equine pericardium, etc.; the leaflets 12 can also be made of submucosal tissue of the small intestine; the leaflets 12 can also be made of synthetic materials, such as expanded polytetrafluoroethylene, polyester, thermoplastic polycarbonate polyurethane, polyether polyurethane, segmented polyether polyurethane, silicone polyether polyurethane, silicone-polycarbonate polyurethane, or ultra-high molecular weight polyethylene. In addition, the leaflets 12 can also use biocompatible polymers, such as polyolefins, elastomers, polyethylene glycol, polyethersulfone, polysulfone, polyvinylpyrrolidone, polyvinyl chloride, other fluoropolymers, silicone polyesters, siloxane polymers, and combinations thereof. The strip 13 is elastic and has an elongation of less than 50%. Excessive elongation will result in insufficient connection strength of the leaflets 12. The material of the strip 13 is preferably a polymer material or a metal material. The polymer material is, for example, PET, PE or PP, and the metal material is, for example, nickel-titanium. The cross-section of the strip 13 is preferably circular or square, but is not limited thereto.

[0046] like Figure 3 As shown, the leaflet 12 includes a leaflet connecting portion 121, a leaflet arc portion 122, and a leaflet free edge 123, which are fixedly connected in sequence. The leaflet free edge 123 is a free end and is not fixed to the support 11. The strip 13 includes a connecting strip 131 and an arc strip 132. The connecting strip 131 is fixedly connected between the leaflet connecting portion 121 and the support 11, and the arc strip 132 is fixedly connected between the leaflet arc portion 122 and the support 11. The arc strip 132 is arranged along the arc direction of the leaflet arc portion 122. In this embodiment, the connecting line 14 includes a first suture 141 and a second suture 142. The first suture 141 is used to fix the connecting strip 131 and the support 11, and the second suture 142 is used to fix the arc strip 132 and the support 11.

[0047] Preferably, the leaflet junction 121 of two adjacent leaflets 12 are connected by two junction strips 131 (i.e., two junction strips 131), and the leaflet junction 121 and the free edge 123 of the leaflet form an L-shape. Then, the junction strips 131 are fixed to the support 11 by the first suture 141. The two junction strips 131 of the two adjacent leaflets 12 work together to make the two leaflets 12 fit together tightly, which can prevent the leaflets 12 from opening too much and hitting the support 11, causing damage to the leaflets 12. At the same time, when the leaflets 12 are closed, the two adjacent leaflets 12 can fit together more tightly, reducing the phenomenon of valve regurgitation.

[0048] In another preferred embodiment, the leaflet connecting portions 121 of two adjacent leaflets 12 can be connected in series by a connecting strip 131 and then fixed to the bracket 11 by the first suture 141, so as to save materials and costs.

[0049] like Figure 3 and Figure 4 As shown, the leaflet 12 includes a first surface 12a and a second surface 12b disposed opposite to each other. The arcuate portion 122 of the leaflet includes a starting region 101 and an ending region 102 disposed at intervals. An arcuate strip 132 starts from the starting region 101 and passes through the first surface 12a to the second surface 12b and then from the second surface 12b to the first surface 12a at intervals of a first distance, and so on, interlacing until it reaches the ending region 102. The interlacing path of the arcuate strip 132 can be a straight line or an arc, etc. In this embodiment, when connecting the arc strip 132 to the arc portion 122 of the leaflet, one end of the arc strip 132 needs to be knotted and fixed in the starting area 101 before being inserted into the arc portion 122 of the leaflet. When the arc strip 132 is inserted into the ending area 102, it is knotted and fixed again in the ending area 102 to prevent the arc strip 132 from falling off. Therefore, after the leaflet 12 is placed in the stent 11, the second suture 142 is used to pass through the arc strip 132 and fix it to the stent 11. The second suture 142 does not pass through the leaflet 12, so that the leaflet 12 and the stent 11 are indirectly fixed through the arc strip 132. When the leaflet 12 is closed and subjected to the impact of blood flow, the arc strip 132 can provide a buffer force for the leaflet 12 and reduce the stress on the leaflet 12.

[0050] like Figure 3 As shown, when the arcuate strip 132 is a single strip, it continuously intersects the arcuate portion 122 of the leaflet, and both ends of the arcuate strip 132 are knotted and fixed; as shown Figure 5As shown, the arcuate strip 132 can be knotted on the second surface 12b every time it passes from the first surface 12a to the second surface 12b; or the arcuate strip 132 can be knotted every time it passes from the first surface 12a to the second surface 12b, and knotted once when it passes from the second surface 12b to the first surface 12a; or the arcuate strip 132 can be knotted after passing through the first surface 12a to the second surface 12b at least twice. The strip 13 can be knotted according to actual needs, which can prevent the arcuate part 122 of the leaflet from excessively contracting along the arcuate strip 132 when the leaflet 12 is subjected to excessive force.

[0051] In another preferred embodiment, when at least two arcuate strips 132 are provided, each arcuate strip 132 is interspersed with the petal arcuate portion 122 at a predetermined distance. In this embodiment, when there are two arc strips 132, one arc strip 132 is connected to the leaflet arc portion 122, and both ends of the arc strip 132 are knotted and fixed. Then, the other arc strip 132 is connected to the leaflet arc portion 122, and both ends of the arc strip 132 are knotted and fixed. The start and end of the two arc strips 132 are spaced at a set distance to reduce material waste and cost increase. When there are multiple arc strips 132, each arc strip 132 can be fixed one loop at a time. That is, after an arc strip 132 passes through the first surface 12a and the second surface 12b, it is knotted and fixed. This is repeated until the starting area 101101 to the ending area 102 of the leaflet arc portion 122 is connected with arc strips 132, and the adjacent loops of arc strips 132 are spaced apart.

[0052] like Figures 6 to 8As shown, the leaflet junction 121 protrudes from the leaflet 12 in a direction away from the centerline of the leaflet 12, and the connecting strip 131 is spirally wound along the length of the leaflet junction 121. In this embodiment, the connecting strip 131 is wound from the first surface 12a to the second surface 12b, and then from the second surface 12b back to the first surface 12a. The connecting strip 131 does not pass through the leaflet junction 121, so there is no pinhole damage to the leaflet junction 121. The connecting strip 131 is wound at least one turn when it wraps around the leaflet junction 121. One turn is defined as the connecting strip 131 wrapping from the first surface 12a to the second surface 12b and then returning to the first surface 12a. The connecting strip 131 is wound along the leaflet junction 121. The first surface 12a and the second surface 12b of the connecting part 121 are closely arranged around the leaflet connecting part 121. When the first suture 141 sutures and fixes the connecting strip 131 to the support 11, at least both ends of the first suture 141 should be knotted and fixed. Since the leaflet connecting part 121 is subjected to the greatest tension when the valve is closed, and the traditional method of directly connecting the leaflet connecting part 121 and the support 11 with sutures is prone to pinhole damage and is often the first to tear, the connecting strip 131 in this embodiment only wraps around the leaflet connecting part 121 and does not penetrate the leaflet connecting part 121. This arrangement can avoid pinhole damage to the leaflet connecting part 121, reduce the stress on the leaflet 12, and improve the service life of the leaflet 12.

[0053] Preferably, the leaflet junctions 121 of two adjacent leaflets 12 are connected by connecting strips 131.

[0054] Preferably, when the bracket 11 is a skirted bracket 11, the skirted bracket 11 includes a bracket body and a skirt connected to the bracket body, and the strip 13 and the skirt are connected by a connecting line 14.

[0055] In another preferred embodiment, when the bracket 11 is a skirtless bracket 11, the strip 13 is connected to the skirtless bracket 11 by a connecting line 14.

[0056] Preferably, the connecting wire 14 is single-stranded or multi-stranded, and the material of the connecting wire 14 is preferably PE or PP, etc. The skirt of the skirted support 11 at least partially covers the support body. The support body can provide several functions for the artificial heart valve, including serving as the main structure of the valve, supporting the internal artificial valve leaflet 12, and the connection structure (hook or fixation ear) with the delivery system, etc. The material of the skirt can be knitted, woven, or braided polyester fabric, PTFE or ePTFE, etc.

[0057] Preferably, the stent 11 can be woven or cut. The material of the stent 11 is preferably nickel-titanium, titanium alloy, cobalt-chromium alloy, MP35n or 316 stainless steel, etc. It can also be a biocompatible metal frame made of other biocompatible metals known to those skilled in the art or a laser-cut solid metal tube, such as nickel-titanium material. In addition, the stent 11 can also be a material that is elastic or plastically deformable, such as an expandable balloon material.

[0058] Second Embodiment

[0059] The artificial heart valve in this embodiment is structurally similar to the artificial heart valve in the first embodiment, except that the arc strips 132 are connected differently.

[0060] Specifically, such as Figure 9 As shown, the leaflet 12 includes a first surface 12a and a second surface 12b disposed opposite to each other. The leaflet arc portion 122 includes a starting region 101 and an ending region 102 disposed at intervals. The arc strip 132 starts from the starting region 101 and passes through the first surface 12a to the second surface 12b and from the second surface 12b to the first surface 12a at intervals of a first distance, and so on, until it reaches the ending region 102. Then, starting from the ending region 102, it passes through the first surface 12a to the second surface 12b and from the second surface 12b to the first surface 12a at intervals of a second distance, and so on, until it reaches the starting region 101. Then, a second suture 142 is used to pass through the arc strip 132 and the bracket 11 for fixation. This can reduce the suture spacing and increase the connection strength of the leaflet 12.

[0061] Third Embodiment

[0062] The artificial heart valve in this embodiment is structurally similar to the artificial heart valve in the first embodiment, except that the arc strips 132 are connected differently.

[0063] Specifically, such as Figure 10As shown, the arcuate strip 132 includes a first strip 1321 and a second strip 1322. The leaflet 12 includes a first surface 12a and a second surface 12b disposed opposite to each other. The arcuate portion 122 of the leaflet includes a starting region 101 and an ending region 102 disposed at intervals. The first strip 1321 starts from the starting region 101 and passes through the first surface 12a to the second surface 12b and back to the first surface 12a at intervals of a first distance, and repeats this process until it reaches the ending region 102. The second strip 1322 starts from the ending region 102 and passes through the first surface 12a to the second surface 12b and back to the first surface 12a at intervals of a second distance, and repeats this process until it reaches the starting region 101. Then, a second suture 142 is used to pass through the arcuate strip 132 and the bracket 11 for fixation. This reduces the suture spacing and increases the connection strength of the leaflet 12. In this embodiment, the first distance and the second distance can be the same or different, but the interlacing method between the first strip 1321 and the second strip 1322 is preferably staggered interlacing.

[0064] Fourth embodiment

[0065] The artificial heart valve in this embodiment is structurally similar to the artificial heart valve in the first embodiment, except that the arc strips 132 are connected differently.

[0066] Specifically, as shown in Figure 11, the arcuate strip 132 includes a first strip 1321 and a second strip 1322. The leaflet 12 includes a first surface 12a and a second surface 12b disposed opposite to each other. The arcuate portion 122 of the leaflet includes a starting region 101 and an ending region 102 disposed at intervals. The first strip 1321 and the second strip 1322 are disposed parallel to each other. The first strip 1321 and the second strip 1322 start from the starting region 101 and pass through the first surface 12a to the second surface 12b at intervals of a first distance, respectively. Reaching the first surface 12a and repeating this process until reaching the endpoint region 102 can increase the connection strength of the leaflet 12. It is understood that the first strip 1321 and the second strip 1322 pass through the starting region 101 and the endpoint region 102 in parallel, but there is no restriction on the order in which the first strip 1321 and the second strip 1322 pass through. After connecting the first strip 1321 and the second strip 1322 to the leaflet arc portion 122, the second suture 142 is used to connect the first strip 1321, the second strip 1322 and the support 11.

[0067] Fifth embodiment

[0068] The artificial heart valve in this embodiment is structurally similar to the artificial heart valve in the first embodiment, except that the arc strip 132 is connected at different positions.

[0069] like Figure 12and Figure 13 As shown, Figure 12 and Figure 13 The difference is Figure 12 The second suture 142 is connected to the leaflet arc portion 122 in a different way. Figure 12 The second suture 142 crosses the fixed arcuate strip 132 and the arcuate portion of the leaflet 122 in a single reciprocating motion. Figure 13 The second suture 142 passes through the fixed arcuate strip 132 and the leaflet arcuate portion 122 in a series of loops. It is understood that the suturing method of the second suture 142 in this application is diverse and will not be elaborated upon here. The strip 13 is connected to the stent 11, and the strip 13 is connected to the leaflet 12 via a connecting line 14. In this embodiment, the arcuate strip 132 is first connected to the stent 11, and at least two ends of the arcuate strip 132 are fixed by knots to prevent it from falling off the stent 11. Then, the arcuate strip 132 is connected to the leaflet 12 via the second suture 142. Thus, there is no direct connection between the stent 11 and the leaflet arcuate portion 122. When the leaflet 12 is closed and subjected to blood flow impact, the arcuate strip 132 can provide cushioning force to the leaflet 12, reducing the stress on the leaflet 12.

[0070] Preferably, the bracket 11 includes a first end 111 and a second end 112 disposed opposite to each other. Along the first end 111 toward the second end 112, an arcuate strip 132 is fixedly connected to the bracket 11 in a spiral winding manner. When the arcuate strip 132 is a single strip, the arcuate strip 132 is continuously wound around the bracket 11.

[0071] In another preferred embodiment, when at least two arcuate strips 132 are provided, each arcuate strip 132 is wound around the petal arcuate portion 122 at a predetermined interval. Specifically, when two arcuate strips 132 are provided, one arcuate strip 132 is wound around the support 11 starting from the first end 111. After the arcuate strip 132 is wound, the other arcuate strip 132 continues to be wound around the support 11 from the previous arcuate strip 132, and wound to the second end 112 of the support 11. Both ends of the two arcuate strips 132 need to be knotted for fixation; alternatively, a knot can be tied for fixation after each time the target distance is reached, and this process is repeated. Figure 14 As shown, when multiple arc-shaped strips 132 are provided, they can be wound around the bracket 11 one loop at a time. One arc-shaped strip 132 is wrapped around the bracket 11 once and then knotted to secure it. Then another arc-shaped strip 132 is wrapped around the bracket 11 once and knotted to secure it, and so on, until the area between the first end 111 and the second end 112 of the bracket 11 is connected with arc-shaped strips 132. It is understood that adjacent arc-shaped strips 132 are spaced apart to save materials and costs.

[0072] Sixth Embodiment

[0073] The artificial heart valve in this embodiment is structurally similar to the artificial heart valve in the fifth embodiment, except that the arc strips 132 are connected differently.

[0074] Specifically, the support 11 includes a first end 111 and a second end 112 disposed opposite to each other. Along the first end 111 toward the direction closer to the second end 112, an arcuate strip 132 is spirally wound clockwise around the support 11 to the second end 112. Then, along the second end 112 toward the direction closer to the first end 111, the arcuate strip 132 is spirally wound counterclockwise around the support 11 to the first end 111. Then, a second suture 142 is used to pass through the arcuate strip 132 and the leaflet arcuate portion 122 for fixation. This can reduce the suture spacing and increase the connection strength of the leaflet 12.

[0075] Seventh Embodiment

[0076] The artificial heart valve in this embodiment is structurally similar to the artificial heart valve in the fifth embodiment, except that the arc strips 132 are connected differently.

[0077] Specifically, the arcuate strip 132 includes a third strip and a fourth strip. The support 11 includes a first end 111 and a second end 112 disposed opposite to each other. Along the first end 111 toward the direction closer to the second end 112, the third strip spirally wraps around the support 11 clockwise from the first end 111 to the second end 112. Along the second end 112 toward the direction closer to the first end 111, the fourth strip spirally wraps around the support 11 counterclockwise from the second end 112 to the first end 111. Then, the second suture 142 is used to pass through the arcuate strip 132 and the leaflet arcuate portion 122 for fixation. This can reduce the suture spacing and increase the connection strength of the leaflet 12.

[0078] Eighth embodiment

[0079] The artificial heart valve in this embodiment is structurally similar to the artificial heart valve in the fifth embodiment, except that the arc strips 132 are connected differently.

[0080] Specifically, the arcuate strip 132 includes a third strip and a fourth strip. The support 11 includes a first end 111 and a second end 112 arranged opposite to each other. The third strip and the fourth strip are arranged parallel to each other. The third strip and the fourth strip are wound clockwise around the support 11 along the first end 111 towards the second end 112, which can increase the connection strength of the leaflet 12. It can be understood that the third strip and the fourth strip are inserted parallel from the first end 111 to the second end 112. The two ends of the third strip and the fourth strip are knotted and fixed. Knotting can also be done during the winding process as needed. The number of knots is not limited. After the first strip 1321 and the second strip 1322 are connected to the arcuate part of the leaflet 122, the third strip and the fourth strip are connected to the arcuate part of the leaflet 122 using the second suture 142.

[0081] The artificial heart valve of this invention uses a strip 13 fixedly connected to the leaflet 12, and then uses a connecting wire 14 to connect the strip 13 to the stent 11, or the strip 13 is fixedly connected to the stent 11, and then the connecting wire 14 is used to connect the strip 13 to the leaflet 12. The strip 13 is used as an intermediate medium connecting the stent 11 and the leaflet 12 to ensure that there is no direct connection between the leaflet 12 and the stent 11. This allows the artificial heart valve to increase the buffering force of the leaflet 12, reduce the stress on the leaflet 12, and extend the service life of the valve when it works in the human heart chamber.

[0082] The above are merely specific embodiments of this utility model, but the protection scope of this utility model is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in this utility model should be included within the protection scope of this utility model. Therefore, the protection scope of this utility model should be determined by the appended claims.

Claims

1. An artificial heart valve, characterized in that, The device includes a support (11), leaflets (12), strips (13), and connecting lines (14). The leaflets (12) are housed within the support (11). Each leaflet (12) has at least two leaflets and is symmetrically distributed along the circumferential direction of the inner surface of the support (11). The strips (13) are connected to the leaflets (12), and the strips (13) are connected to the support (11) via the connecting lines (14). Alternatively, the strip (13) is connected to the support (11), and the strip (13) is connected to the leaflet (12) via the connecting line (14).

2. The artificial heart valve as described in claim 1, characterized in that, The leaflet (12) includes a leaflet connecting part (121) and a leaflet arc part (122) that are fixedly connected in sequence. The strip (13) includes a connecting strip (131) and an arc strip (132). The connecting strip (131) is fixedly connected between the leaflet connecting part (121) and the support (11). The arc strip (132) is fixedly connected between the leaflet arc part (122) and the support (11). The arc strip (132) is arranged along the arc direction of the leaflet arc part (122).

3. The artificial heart valve as described in claim 2, characterized in that, The leaflet (12) includes a first surface (12a) and a second surface (12b) disposed opposite to each other, and the leaflet arc portion (122) includes a starting region (101) and an ending region (102) disposed at intervals. The arc strip (132) starts from the starting region (101) and passes through the first surface (12a) to the second surface (12b) and from the second surface (12b) to the first surface (12a) at a first distance, and so on, until the ending region (102).

4. The artificial heart valve as described in claim 3, characterized in that, When there is one arc strip (132), the arc strip (132) is continuously intersected by the arc portion (122) of the leaflet; When there are at least two arc strips (132), each arc strip (132) is interspersed with the petal arc portion (122) at a set distance.

5. The artificial heart valve as described in claim 2, characterized in that, The leaflet (12) includes a first surface (12a) and a second surface (12b) disposed opposite to each other. The arcuate portion (122) of the leaflet includes a starting region (101) and an ending region (102) disposed at intervals. The arcuate strip (132) starts from the starting region (101) and passes through the first surface (12a) to the second surface (12b) and from the second surface (12b) to the first surface (12a) at intervals of a first distance, and so on, until it reaches the ending region (102). Then, starting from the ending region (102), it passes through the first surface (12a) to the second surface (12b) and from the second surface (12b) to the first surface (12a) at intervals of a second distance, and so on, until it reaches the starting region (101).

6. The artificial heart valve as described in claim 2, characterized in that, The arc strip (132) includes a first strip (1321) and a second strip (1322), the leaflet (12) includes a first surface (12a) and a second surface (12b) disposed opposite to each other, and the arc portion (122) of the leaflet includes a starting region (101) and an ending region (102) disposed at intervals. The first strip (1321) starts from the starting region (101) and travels from the first surface (12a) to the second surface (12b) and from the second surface (12b) to the first surface (12a) at first intervals of a first distance, repeating this process until it reaches the ending region (102); the second strip (1322) starts from the ending region (102) and travels from the first surface (12a) to the second surface (12b) and from the second surface (12b) to the first surface (12a) at second intervals of a second distance, repeating this process until it reaches the starting region (101); Alternatively, the first strip (1321) and the second strip (1322) may start from the starting region (101) and pass through the first surface (12a) to the second surface (12b) and from the second surface (12b) to the first surface (12a) at a first distance, respectively, and repeat in this way to reach the ending region (102), with the first strip (1321) and the second strip (1322) arranged in parallel.

7. The artificial heart valve as described in claim 2, characterized in that, The bracket (11) includes a first end (111) and a second end (112) disposed opposite to each other. Along the first end (111) toward the direction close to the second end (112), the arc strip (132) is fixedly connected to the bracket (11) in a spiral winding manner.

8. The artificial heart valve as described in claim 7, characterized in that, When there is one arc strip (132), the arc strip (132) is continuously wrapped around the bracket (11); When at least two arc strips (132) are provided, each arc strip (132) is wrapped around the petal arc portion (122) at a set interval.

9. The artificial heart valve as described in claim 2, characterized in that, The bracket (11) includes a first end (111) and a second end (112) disposed opposite to each other. Along the first end (111) toward the direction closer to the second end (112), the arc strip (132) is spirally wound clockwise around the bracket (11) to the second end (112), and then along the second end (112) toward the direction closer to the first end (111), the arc strip is spirally wound counterclockwise around the bracket (11) to the first end (111).

10. The artificial heart valve as described in claim 2, characterized in that, The arc strip (132) includes a third strip and a fourth strip, and the bracket (11) includes a first end (111) and a second end (112) disposed opposite to each other. Along the first end (111) toward the direction closer to the second end (112), the third strip is spirally wound clockwise around the bracket (11) to the second end (112), and along the second end (112) toward the direction closer to the first end (111), the fourth strip is spirally wound counterclockwise around the bracket (11) to the first end (111). Alternatively, the third strip and the fourth strip may be arranged in parallel, and the third strip and the fourth strip may be wound clockwise around the bracket (11) from the first end (111) toward the second end (112).

11. The artificial heart valve as described in claim 2, characterized in that, The leaflet connecting portion (121) is formed by protruding from the leaflet (12) in a direction away from the centerline of the leaflet (12), and the connecting strip (131) is spirally wound along the length direction of the leaflet connecting portion (121).

12. The artificial heart valve as described in claim 11, characterized in that, The leaflet junctions (121) of two adjacent leaflets (12) are connected by a junction strip (131); or the leaflet junctions (121) of two adjacent leaflets (12) are connected by each junction strip (131).

13. The artificial heart valve as described in claim 2, characterized in that, The leaflet (12) also includes a leaflet free edge (123). After the strip (13) is connected to the support (11), an L-shape is formed between the leaflet free edge (123) and the leaflet connecting part (121).

14. The artificial heart valve as described in claim 2, characterized in that, When the bracket (11) is a skirted bracket (11), the skirted bracket (11) includes a bracket body and a skirt connected to the bracket body, and the strip (13) and the skirt are connected by the connecting line (14). When the bracket (11) is a skirtless bracket (11), the strip (13) is connected to the skirtless bracket (11) through the connecting line (14).

15. The artificial heart valve as described in claim 1, characterized in that, The strip (13) is elastic and has an elongation of less than 50%.

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