Valve expansion device with reinforcement and valve expansion system

Abstract

The present invention discloses a valve expansion device with a reinforcement and a valve expansion system. The valve expansion device with a reinforcement includes a stent and at least one reinforcement. The stent includes a proximal end and a distal end that are arranged opposite to each other in the axial direction, and at least two expansion arms connected between the proximal end and the distal end. Each expansion arm can be expanded or compressed along the radial direction of the stent, and at least one expansion arm is provided with a cutting portion on the side away from the other expansion arms. The reinforcement is fixedly connected between two adjacent expansion arms, and the reinforcement and the expansion arm are synchronously expanded or compressed along the radial direction of the stent. The valve expansion device with a reinforcement provided in an embodiment of the present invention connects the expansion arms in pairs by arranging reinforcements so that the expansion arms are indirectly fixedly connected together, which can prevent the expansion arms from being deformed by external forces and concave radially inward during radial expansion, so that the expansion arms can continue to expand outward to ensure the expansion effect.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a valve expansion device with a reinforcement member and a valve expansion system. Background Art

[0002] Valvular stenosis, such as aortic stenosis, is a common valvular disease. Aortic stenosis is mainly caused by the sequelae of rheumatic fever, congenital aortic valve structural abnormalities or senile aortic valve calcification. On the one hand, it can cause insufficient blood supply to various organs in the body, and on the other hand, it can cause a relative decrease in coronary blood flow, resulting in insufficient oxygen supply to the heart, which may eventually lead to complications such as arrhythmia, pulmonary hypertension, coronary heart disease, and heart failure.

[0003] In the prior art, aortic valve stenosis is treated by a radially expandable structure that can change between a collapsed position and an expanded position. The expandable structure is composed of a plurality of expansion arms, and the expandable structure can be radially expanded or collapsed by operation, so that the ablation portion on the expansion arm can be used to perform expansion and ablation on the valve adhesion. However, when the expansion arm expands radially outward, it will be subjected to a radially inward force from the valve / tissue, and can only rely on the rigidity of the expansion arm itself to resist the force. Once the force exceeds the rigidity of the expansion arm itself, it will deform, especially the middle part of the expansion arm, causing the expansion arm to concave radially inward, which will cause the expansion arm to be insufficient to continue to expand outward, thereby greatly reducing the effect of expansion ablation, and the range of ablation cutting can only be maintained within a lower level after the expansion arm is concave and deformed. Summary of the invention

[0004] In order to solve the technical problem that the expansion arms in the valve expansion device are easily deformed during radial expansion, the present invention provides a valve expansion device with a reinforcement and a valve expansion system.

[0005] In a first aspect, the present invention provides a valve expansion device with a reinforcement member, comprising:

[0006] A stent, the stent comprising a proximal end and a distal end disposed opposite to each other in the axial direction, and at least two expansion arms connected between the proximal end and the distal end, each of the expansion arms being expandable or compressible in the radial direction of the stent, and at least one of the expansion arms being provided with a cutting portion on a side away from the other expansion arms; and

[0007] At least one reinforcing member is fixedly connected between two adjacent expansion arms, and the reinforcing member and the expansion arms are synchronously expanded or compressed along the radial direction of the stent.

[0008] In a second aspect, the present invention provides a valve expansion system, comprising a delivery device and the above-mentioned valve expansion device;

[0009] The conveying device includes an inner tube, an intermediate tube and an outer tube, the intermediate tube is slidably arranged in the outer tube, the inner tube is slidably arranged in the intermediate tube, the proximal end of the bracket is fixedly connected to the distal end of the intermediate tube, the distal end of the bracket can be slidably mounted on the inner tube, and a limiting member is arranged at the distal end of the inner tube.

[0010] The above technical solution provided by the embodiment of the present invention has the following advantages compared with the prior art:

[0011] In the valve expansion device and valve expansion system with reinforcement provided by the embodiment of the present invention, the reinforcement connects the expansion arms in pairs so that the expansion arms are indirectly fixedly connected together, and the cutting portion of the expansion arm can be used to gradually cut and continuously expand the valve adhesion. When the expansion arm expands radially outward, it is subjected to a radially inward force from the valve tissue. Since the reinforcement and the expansion arm expand radially synchronously, the reinforcement is simultaneously subjected to the force, and the reinforcement will generate a reaction force acting on the expansion arm. At this time, the rigidity of the expansion arm itself and the reaction force from the reinforcement act together on the expansion arm to resist the tendency of deformation when subjected to external force, and prevent the expansion arm from being concave radially inward, so that the expansion arm can continue to expand outward, and ensure the expansion effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0013] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, for ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0014] In the attached figure:

[0015] Figure 1 and Figure 2 is a schematic structural diagram of a valve expansion device provided in Embodiment 1 of the present invention;

[0016] Figure 3 and Figure 4 is a schematic structural diagram of a valve expansion system provided in Embodiment 1 of the present invention;

[0017] Figure 5 is an operation schematic diagram of the valve expansion system provided in Embodiment 1 of the present invention;

[0018] Figures 6 to 9 is a schematic structural diagram of a valve expansion device provided in Embodiment 2 of the present invention;

[0019] Fig.10 and Fig.11 is a schematic structural diagram of a valve expansion device provided in Embodiment 3 of the present invention;

[0020] Figures 12 to 16 is a schematic structural diagram of a valve expansion device provided in Embodiment 4 of the present invention;

[0021] Fig.17 It is a schematic diagram of the operation of the valve expansion system provided in the fourth embodiment of the present invention.

[0022] Fig.18 and Fig.19 It is a schematic diagram of the structure of the valve expansion device provided in Example 5 of the present invention. DETAILED DESCRIPTION

[0023] In order to have a clearer understanding of the technical features, purposes and effects of the present invention, the specific embodiments of the present invention are now described in detail with reference to the accompanying drawings. In the following description, it should be understood that the directions or positional relationships indicated by "front", "back", "up", "down", "left", "right", "longitudinal", "horizontal", "vertical", "horizontal", "top", "bottom", "inside", "outside", "head", "tail", etc. are based on the directions or positional relationships shown in the accompanying drawings, are constructed and operated in a specific direction, and are only for the convenience of describing the present technical solution, rather than indicating that the device or element referred to must have a specific direction, and therefore cannot be understood as a limitation to the present invention.

[0024] It should also be noted that, unless otherwise clearly specified and limited, the terms such as "installed", "connected", "connected", "fixed", "set" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral one; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. When an element is referred to as being "on" or "under" another element, the element can be "directly" or "indirectly" located on the other element, or there may be one or more intermediate elements. The terms "first", "second", "third", etc. are only for the convenience of describing the present technical solution, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first", "second", "third", etc. can explicitly or implicitly include one or more of the features. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances.

[0025] In the following description, specific details such as specific system structures, technologies, etc. are provided for the purpose of illustration rather than limitation, so as to provide a thorough understanding of the embodiments of the present invention. However, it should be clear to those skilled in the art that the present invention may be implemented in other embodiments without these specific details. In other cases, detailed descriptions of well-known systems, devices, circuits, and methods are omitted to prevent unnecessary details from obstructing the description of the present invention.

[0026] In the description of the present invention, it should be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator; the axial direction refers to the direction parallel to the line connecting the distal center and the proximal center of the medical device. The above definitions are only for the convenience of expression and cannot be understood as limitations of the present invention.

[0027] Embodiment 1:

[0028] refer to Figures 1 to 5 , Embodiment 1 of the present invention provides a valve expansion device 100 with a reinforcement member 120, including a stent 110 and at least one reinforcement member 120. The stent 110 includes a proximal end 111 and a distal end 112 that are axially opposite to each other, and at least two expansion arms 113 connected between the proximal end 111 and the distal end 112. Each expansion arm 113 can be expanded or compressed along the radial direction of the stent 110, and at least one expansion arm 113 is provided with a cutting portion 1131 on a side away from the other expansion arms 113. The reinforcement member 120 is fixedly connected between two adjacent expansion arms 113, and the reinforcement member 120 and the expansion arm 113 are synchronously expanded or compressed along the radial direction of the stent 110.

[0029] The valve expansion device 100 with the reinforcement member 120 is connected to the expansion arms 113 in pairs by the reinforcement member 120 so that the expansion arms 113 are indirectly fixedly connected together, and the cutting portion 1131 of the expansion arm 113 is used to gradually cut and continuously expand the valve adhesion. When the expansion arm 113 expands radially outward, it is subjected to a radially inward force from the valve tissue. Since the reinforcement member 120 and the expansion arm 113 expand radially synchronously, the reinforcement member 120 is subjected to the force at the same time, and the reinforcement member 120 will generate a reaction force acting on the expansion arm 113. At this time, the rigidity of the expansion arm 113 itself and the reaction force from the reinforcement member 120 act together on the expansion arm 113 to resist the tendency of deformation when subjected to external force, and prevent the expansion arm 113 from being concave radially inward, so that the expansion arm 113 can continue to expand outward, and ensure the expansion effect.

[0030] Here, the direction of the expansion arm 113 toward the central axis L1 of the stent 110 is defined as inward, and the direction away from the central axis L1 is defined as outward. The central axis L1 refers to the center line connecting the distal end 112 and the proximal end 111 of the stent 110, the axial direction is the direction along the central axis L1, and the radial direction is the direction perpendicular to the central axis L1.

[0031] It can be understood that a reinforcement member 120 is provided and fixedly connected between two adjacent expansion arms 113. When the expansion arms 113 are radially compressed inward or expanded outward, the reinforcement member 120 is simultaneously compressed or expanded, thereby providing a certain supporting force to the expansion arms 113, thereby preventing the expansion arms 113 from being radially sunken inward due to external forces during the process of radially expanding outward, thereby achieving a better expansion effect of the expansion arms 113.

[0032] Considering the anatomical structure of the valve, the number of expansion arms 113 may be less than or equal to the number of leaflets 71 constituting the valve, so that the expansion arms 113 can radially expand into the calcified junction of adjacent leaflets 71, and the adhesion sites at the junction of adjacent leaflets 71 are cut by the cutting portion 1131, such as mechanical cutting or ablation cutting, so as to achieve valve expansion. The mitral valve has two leaflets 71, and the aortic valve, tricuspid valve, and pulmonary valve all have three leaflets 71. In addition, in order to set a reinforcement member 120 connected between two adjacent expansion arms 113 to prevent the expansion arms 113 from being radially inwardly concave due to external forces during the process of radially outward expansion, the number of expansion arms 113 is at least two.

[0033] The expansion arms 113 can be distributed at intervals along the circumference, preferably uniformly arranged in the circumference. Of course, the expansion arms 113 can also be arranged non-uniformly in the circumference. The structures of two and three expansion arms 113 can be respectively applicable to bicuspid valve stenosis and tricuspid valve stenosis. Since the cutting portion 1131 of two or three expansion arms 113 does not surround the circumference to form a cylindrical shape similar to the middle of the balloon, the cutting portion 1131 can accurately fit into the junction gap of two adjacent leaflets 71 to cut the calcified adhesion part at the junction, thereby achieving the purpose of expanding the valve area and alleviating a series of adverse symptoms caused by valve stenosis. It is worth noting that the number of expansion arms 113 should not be set too much to prevent all expansion arms 113 from circumferentially contacting the leaflets 71 like a balloon, and unable to enter the junction gap between adjacent leaflets 71. When the number of expansion arms 113 is two, the angle between the two expansion arms 113 is 180°. When the number of expansion arms 113 is three, the angle between the two adjacent expansion arms 113 is 120°.

[0034] It is worth mentioning that the valve expansion device 100 should be guided to the treatment site by external images, such as computed tomography (CT), fluoroscopy, intravascular ultrasound (IVUS), optical coherence tomography (OCT), intracardiac echocardiography (ICE), etc. Therefore, a developing part should be provided on at least one expansion arm 113, and the developing part is preferably made of metal materials such as platinum, platinum, and tantalum. Preferably, each expansion arm 113 is provided with a developing part.

[0035] The expansion arm 113 includes a cutting segment 1132 and two supporting segments 1133 respectively arranged at both ends of the cutting segment 1132. The other end of one of the supporting segments 1133 is connected to the proximal end 111 of the stent 110, and the other end of the other supporting segment 1133 is connected to the distal end 112 of the stent 110. The cutting portion 1131 is arranged at the cutting segment 1132, and the reinforcing member 120 is fixedly connected between two adjacent cutting segments 1132. It can be understood that one end of the supporting segment 1133 close to the proximal end 111 is connected to the proximal end 111, and the other end is connected to the cutting segment 1132; one end of the supporting segment 1133 close to the distal end 112 is connected to the distal end 112, and the other end is connected to the cutting segment 1132. The cutting segment 1132 is parallel to the central axis L1 of the stent 110. In this way, the supporting segment 1133 can support both ends of the cutting segment 1132. The cutting portion 1131 is arranged in the middle cutting section 1132, which makes it easier for the cutting portion 1131 to align with the adhesion portion at the junction of adjacent leaflets 71 for cutting. Preferably, the cutting portion 1131 is arranged on the entire cutting section 1132 or on the middle portion between the two ends of the cutting section 1132. A reinforcement member 120 is extended obliquely along the axial direction toward the central axis L1 of the stent 110 at one end of the cutting section 1132. The reinforcement member 120 serves to enhance the expansion force of the valve expansion device 100, and reduces or eliminates the occurrence of concave deformation of the expansion arm 113 (specifically the cutting section 1132) when subjected to external force.

[0036] The proximal end 111 and the distal end 112 of the stent 110 move relative to each other in the axial direction, and the radial distance between one end of each support segment 1133 connected to the corresponding cutting segment 1132 and the central axis L1 of the stent 110 changes, thereby adjusting the radial distance between the cutting segment 1132 (i.e., the cutting portion 1131) and the central axis L1 of the stent 110. Specifically, when the proximal end 111 of the stent 110 approaches the distal end 112 of the stent 110 axially, the axial distance between the proximal end 111 of the stent 110 and the distal end 112 of the stent 110 decreases, and the radial distance between the connection between the support segment 1133 and the cutting segment 1132 and the central axis L1 of the stent 110 increases, and the radial distance between the cutting segment 1132 and the central axis L1 of the stent 110 increases accordingly, so that the cutting portion 1131 on the cutting segment 1132 can progressively cut the adhesions at different radial positions on the junction of adjacent leaflets 71, so that the valve expansion device 100 can adapt to the physiological and anatomical differences of the valves of different individuals. When the proximal end 111 of the stent 110 moves axially away from the distal end 112 of the stent 110, the axial distance between the proximal end 111 of the stent 110 and the distal end 112 of the stent 110 increases, and the radial distance between the connection between the support segment 1133 and the cutting segment 1132 and the central axis L1 of the stent 110 decreases, and the radial distance between the cutting segment 1132 and the central axis L1 of the stent 110 decreases accordingly, so as to facilitate the storage of the valve expansion device 100.

[0037] It should be noted that progressive cutting first maintains a certain radial distance between the cutting portion 1131 and the central axis L1 of the bracket 110, and then slightly increases the radial distance between the cutting portion 1131 and the central axis L1 of the bracket 110 after cutting for a certain period of time, and continues cutting, and repeats this cycle.

[0038] In a natural state, the support segment 1133 is inclined to form an angle with the central axis L1 of the stent 110, and the angle ranges from 30° to 60°. In this way, the radial distance between the end of each support segment 1133 connected to the corresponding cutting segment 1132 and the central axis L1 of the stent 110 changes. The support segment 1133 can be a single support bar, or the support segment 1133 can be composed of two support bars 1133a that extend radially outward along the axial direction and finally merge. Figure 1 Specifically, the two support bars 1133a extend radially outward from the proximal end 111 or the distal end 112 of the stent 110 at a certain angle to the axial direction of the central axis L1 of the stent 110. The two adjacent support bars 1133a eventually gather together and fold at one end of the cutting segment 1132, so that the outer contour of the support segment 1133 is approximately rhombus-shaped.

[0039] refer to Figure 1 and Figure 2In a specific embodiment, the reinforcement member 120 includes a connecting ring 121 and at least two connecting strips 122 respectively connected to the connecting ring 121. The connecting ring 121 is located at the central axis L1 of the stent 110, and each connecting strip 122 is bent and extends from the expansion arm 113 to the connecting ring 121. It can be understood that the connecting ring 121 can be passed through by the delivery device 210 for delivering the valve expansion device 100, such as the inner tube 211 of the delivery device 210 (see the following description for details). The number of the connecting strips 122 depends on the number of the expansion arms 113, and the number of the connecting strips 122 is usually the same as the number of the expansion arms 113.

[0040] In the illustrated example, there are two expansion arms 113 and two connecting strips 122, one end of each of the two connecting strips 122 is connected to the connecting ring 121, and the other end of each of the two connecting strips 122 is connected to the two expansion arms 113. Specifically, the two connecting strips 122 are respectively bent and extended from the ends of the two cutting segments 1132 in different radial planes along the axial direction toward the central axis L1 of the stent 110 to the connecting ring 121, and the two connecting strips 122 extend toward each other along the axial direction, and the starting position of the extension is located at the end of the cutting segment 1132. The extension of the connecting strip 122 starts from the middle position of the end of the cutting segment 1132 and ends at the central plane of the valve expansion device 100 perpendicular to the central axis L1 of the stent 110. In this way, by sequentially connecting one expansion arm 113, one connecting strip 122, the connecting ring 121, another connecting strip 122, and another expansion arm 113, an indirect connection between the two expansion arms 113 is achieved, which is equivalent to adding a fulcrum to the expansion arm 113 to enhance its expansion force.

[0041] When the expansion arm 113 is subjected to an external force inward in the radial direction, the connecting strip 122 will also have a tendency to be compressed inward in the radial direction under the action of the external force. At this time, the connecting ring 121 can be used as a fulcrum to provide a reaction force to be transmitted to the expansion arm 113 to resist the deformation of the expansion arm 113. Therefore, when the expansion arm 113 is subjected to an external force, the rigidity of the expansion arm 113 itself and the reaction force from the reinforcement 120 will act on the expansion arm 113 to resist the tendency of deformation when subjected to the external force, so that the expansion arm 113 can continue to expand outward to ensure the expansion effect.

[0042] The connecting ring 121 is located at the central axis L1 of the stent 110, and is passed through by the inner tube 211 of the conveying device 210. The connecting ring 121 can move back and forth along the axial direction of the inner tube 211. In this way, the two connecting strips 122 connected to the connecting ring 121 can be uniformly stressed when subjected to radially inward external forces, so as not to deflect the connecting ring 121, thereby causing poor expansion effect of the expansion arm 113. Preferably, the central axis of the terminal part of the connecting strip 122 is perpendicular to the central axis L1 of the stent 110, so that the connecting strip 122 and the connecting ring 121 are better connected, avoiding cracks between the connecting strip 122 and the connecting ring 121 under the action of external forces, and at the same time ensuring that the connecting ring 121 will not deflect and can remain concentric with the inner tube 211 of the conveying device 210 (see the following description for details).

[0043] The connecting ring 121 can be made of stainless steel, or a polymer material such as polycarbonate (PC), acrylonitrile-butadiene-styrene (ABS), polyoxymethylene (POM), polypropylene (PP), etc. When the connecting ring 121 is made of a metal material such as stainless steel, the connecting strip 122 is preferably fixedly connected to the connecting ring 121 by welding. When the connecting ring 121 is made of a polymer material, the connecting strip 122 is preferably fixedly connected to the connecting ring 121 by gluing.

[0044] In another specific embodiment, the reinforcement 120 includes a hollow portion (not shown), the hollow portion is located at the central axis L1 of the stent 110, and the reinforcement 120 is bent and extended from one expansion arm 113 to the other expansion arm 113. It can be understood that the hollow portion can be passed through by the delivery device 210 for delivering the valve expansion device 100, such as the inner tube 211 of the delivery device 210 (see the following description for details). The two ends of a reinforcement 120 are respectively connected to the two expansion arms 113, and the two expansion arms 113 are indirectly connected together by sequentially connecting one expansion arm 113, the reinforcement 120, and the other expansion arm 113. When the two expansion arms 113 are subjected to radially inward external forces, the reinforcement 120 can provide a supporting force to the expansion arms 113, so that the expansion arms 113 resist the radially inward external forces, thereby achieving a better expansion effect.

[0045] The stent 110 and the reinforcement 120 can be made of, but are not limited to, metal tubes made of nickel-titanium alloys, copper-nickel shape memory alloys, copper-aluminum shape memory alloys, copper-zinc shape memory alloys, and the like. In addition to cutting the metal tube as a whole, the valve expansion device 100 can also be made by separately manufacturing each part and then welding it. Since nickel-titanium metal tubes have good metal memory and excellent mechanical properties such as strength, stiffness, and elasticity, the valve expansion device 100 is preferably formed by cutting a single nickel-titanium metal tube and then shaping it. Specifically, a single nickel-titanium metal tube of a suitable length is used to complete the cutting under a laser cutting machine, and then the cutting is completed and the shaping process is performed. The valve expansion device 100 after cutting and shaping exhibits a small radial expansion in a natural state.

[0046] refer to Figures 3 to 5 The embodiment of the present invention further provides a valve expansion system 200 , including a delivery device 210 and a valve expansion device 100 with a reinforcement member 210 .

[0047] The delivery device 210 is used to deliver the valve expansion device 100. The delivery device 210 includes an inner tube 211, an intermediate tube 212, and an outer tube 213. The intermediate tube 212 is slidably disposed in the outer tube 213, the inner tube 211 is slidably disposed in the intermediate tube 212, the proximal end 111 of the stent 110 is fixedly connected to the distal end of the intermediate tube 212, the distal end 112 of the stent 110 is slidably sleeved on the inner tube 211, and a limiting member 214 is provided at the distal end of the inner tube 211. In this way, the radial expansion or contraction of the valve expansion device 100 can be controlled by the axial sliding of the inner tube 211 and / or the intermediate tube 212. The inner tube 211 is slidably disposed in the intermediate tube 212, so the axial distance between the distal end of the inner tube 211 and the distal end of the intermediate tube 212 changes with the sliding of the inner tube 211 and / or the intermediate tube 212, and the axial distance determines the expansion degree or contraction degree of the valve expansion device 100.

[0048] The inner tube 211, the middle tube 212, and the outer tube 213 are all hollow tubular structures. In this way, a guide wire can be passed through the hollow inner cavity of the inner tube 211 to guide the valve expansion device 100 into the human body. The middle tube 212 can be movably sleeved on the circumference of the inner tube 211 and can slide axially relative to the inner tube 211, and the outer tube 213 can be movably sleeved on the circumference of the middle tube 212 and can slide axially relative to the middle tube 212. The proximal end 111 of the stent 110 is fixedly connected to the distal end 112 of the middle tube 212, and the fixed connection method includes but is not limited to fusion and welding.

[0049] The proximal end 111 of the stopper 214 is fixedly connected to the distal end 112 of the inner tube 211, and the fixed connection method includes but is not limited to welding or welding. Of course, the proximal end 111 of the stopper 214 and the distal end 112 of the inner tube 211 can also be detachably connected, and the detachable connection method includes but is not limited to snap connection or threaded connection. The distal end 112 of the bracket 110 can be slidably sleeved on the inner tube 211, and the distal end 112 of the bracket 110 can be separated from the stopper 214 and slide on the peripheral side of the inner tube 211. Of course, the distal end 112 of the bracket 110 can also be fixedly connected to the stopper 214. The stopper 214 can be a TIP head.

[0050] The central axis of the outer tube 213, the middle tube 212, and the inner tube 211 coincides with the central axis L1 of the bracket 110, and the connecting ring 121 or the hollow portion of the reinforcing member 120 is sleeved on the circumference of the inner tube 211, and the connecting ring 121 or the hollow portion can move along the axial direction of the inner tube 211. In this way, when the reinforcing member 120 is subjected to a radially inward external force, the connecting ring 121 or the hollow portion can be prevented from deviating from the central axis L1 of the bracket 110, thereby ensuring that the reinforcing member 120 can provide a stronger supporting force to the expansion arm 113, thereby improving the expansion effect of the expansion arm 113.

[0051] The valve expansion system 200 further includes a handle 220, which is provided with a driving mechanism. The proximal end 111 of the inner tube 211 is connected to the driving mechanism, and the driving mechanism controls the inner tube 211 to move axially to achieve relative movement between the inner tube 211 and the intermediate tube 212, thereby adjusting the radial expansion degree of the expansion arm 113 of the valve expansion device 100. Of course, the axial relative movement of the intermediate tube 212 and the outer tube 213 can also be controlled by the driving mechanism, so that the valve expansion device 100 is released from the outer tube 213 or the valve expansion device 100 is stored in the outer tube 213, or the radial expansion degree of the expansion arm 113 of the valve expansion device 100 is adjusted. Specifically, after the valve expansion device 100 is released from the outer tube 213, the outer tube 213 and the middle tube 212 can be kept stationary, and the inner tube 211 can be controlled by the driving mechanism to move toward the proximal end 111, thereby driving the axial compression of the stent 110 and simultaneously making the cutting portion 1131 of the expansion arm 113 gradually expand radially to gradually cut the valve adhesion.

[0052] The valve expansion system 200 further includes an energy generating device 230, and the cutting portion 1131 is at least partially conductive, and the energy generating device 230 is electrically connected to the cutting portion 1131. As the expansion arm 113 expands radially outward, the cutting portion 1131 is driven radially away from the central axis L1 of the stent 110. When the cutting portion 1131 enters the boundary between adjacent leaflets 71 of the valve, the cutting portion 1131 is electrically connected to the energy generating device 230 to release current, thereby ablating and cutting the adhesion portion at the boundary between adjacent leaflets 71, and then the valve is gradually expanded by the expansion arm 113 expanding radially outward.

[0053] The principle of ablation cutting of the cutting part 1131 is: the cutting part 1131 and the negative electrode plate attached to the outside of the human body form a loop, and the energy generating device 230 transmits high-frequency current to the adhesion part through the cutting part 1131, so that the water molecules in the part oscillate rapidly, and the cells are lysed and vaporized, thereby disconnecting the adhesion part at the junction of adjacent leaflets 71, thereby achieving the expansion of the stenotic valve.

[0054] Embodiment 2:

[0055] refer to Figures 6 to 9 The difference between this embodiment and the first embodiment is that the structure of the reinforcement member 320 is different.

[0056] In this embodiment, the reinforcement member 320 is annular, and the connection points of the reinforcement member 320 and each expansion arm 313 are located on the same plane, and the plane is perpendicular to the central axis L2 of the bracket 310. Specifically, the reinforcement member 320 includes at least two reinforcement bars, and the two ends of each reinforcement bar are respectively connected to the expansion arm 313, and the reinforcement bars are connected end to end in sequence to form a ring.

[0057] In a specific embodiment, the reinforcement member 320 includes at least two V-shaped reinforcement strips connected end to end. In the natural state, the V-shaped reinforcement strip presents a V-shaped structure. As the expansion arm 313 gradually expands radially outward, the V-shaped reinforcement strip will be gradually stretched. As the expansion degree of the expansion arm 313 in the radial direction gradually increases, the degree to which the V-shaped reinforcement strip is stretched also gradually increases. When the expansion arm 313 expands to the maximum range, the V-shaped reinforcement strip approaches a straight line. When the valve expansion device 300 is made of an integrally cut tube, the V-shaped reinforcement strip presents a V-shaped structure in the natural state, and the V-shaped reinforcement strip can be stretched by the expansion of the expansion arm 313.

[0058] In this way, the two ends of the V-shaped reinforcement strip are respectively connected to the expansion arms 313, thereby indirectly fixing and connecting at least two expansion arms 313 together. When the expansion arms 313 are subjected to radially inward external force from the valve tissue, the V-shaped reinforcement strip will also be subjected to the external force, but because the V-shaped reinforcement strip is fixedly connected to the expansion arms 313, the V-shaped reinforcement strip will generate a reaction force acting on the expansion arms 313 to resist deformation, thereby strengthening the expansion force of the expansion arms 313 and making them have a stronger ability to resist deformation.

[0059] In the illustrated example, there are two expansion arms 313, and there are also two reinforcement members 320, namely, a first reinforcement member 320a and a second reinforcement member 320b. The first reinforcement member 320a includes a first reinforcement strip 321a and a second reinforcement strip 321b, and the second reinforcement member 320b includes a third reinforcement strip 321c and a fourth reinforcement strip 321d. The first reinforcement member 320a and the second reinforcement member 320b are connected to the proximal end and the distal end of the cutting segment 3131, respectively. The endpoints of the first reinforcement strip 321a and the second reinforcement strip 321b are located in the same plane perpendicular to the central axis L2 of the stent 310 in the radial direction, and the first reinforcement strip 321a and the second reinforcement strip 321b are distributed on both sides of the plane formed by the two expansion arms 313. End points of the third reinforcement strip 321c and the fourth reinforcement strip 321d are radially located in another plane perpendicular to the central axis L2 of the stent 310 , and the third reinforcement strip 321c and the fourth reinforcement strip 321d are symmetrically distributed on both sides of the plane formed by the two expansion arms 313 .

[0060] Of course, the number of reinforcing members 320 can be one, and the reinforcing member 320 is arranged in the middle part between the proximal end and the distal end of the cutting segment 3131. The reinforcing member 320 includes two reinforcing strips, and the two reinforcing strips are distributed on both sides of the plane formed by the two expansion arms 313. In the actual surgical operation process, the external force of the valve tissue on the cutting segment 3131 is closer to the middle part of the cutting segment 3131, so the connection between the reinforcing member 320 and the cutting segment 3131 is located in the middle part of the cutting segment 3131, which can better enhance the ability of the middle part of the cutting segment 3131 to resist deformation. The middle part of the cutting segment 3131 is defined here as the midpoint of the line connecting the proximal end and the distal end of the cutting segment 3131.

[0061] Embodiment three:

[0062] refer to Fig.10 and Fig.11 The difference between this embodiment and the first embodiment is that the structure of the reinforcement member 420 is different.

[0063] Specifically, the valve expansion device 400 includes a stent 410 and at least two reinforcement members 420, and the stent 410 includes at least two expansion arms 413. The reinforcement member 420 is fixedly connected between two adjacent expansion arms 413, and the projections of every two reinforcement members 420 on the same plane intersect each other. The expansion arm 413 includes a cutting segment 4131 and two support segments 4133 fixedly connected to the two ends of the cutting segment 4131.

[0064] In the illustrated example, the stent 410 has a central axis L3. The valve expansion device 400 includes two expansion arms 413 and two reinforcements 420, the two expansion arms 413 include a first cutting segment 4131a and a second cutting segment 4131b, respectively, and the two reinforcements 420 are respectively a first reinforcement 420a and a second reinforcement 420b. The first reinforcement 420a and the second reinforcement 420b are respectively located on both sides of the plane formed by the two expansion arms 413. Among them, the proximal end of the first reinforcement 420a is connected to the proximal end of the first cutting segment 4131a, and the distal end of the first reinforcement 420a is connected to the distal end of the second cutting segment 4131b. The proximal end of the second reinforcement 420b is connected to the proximal end of the second cutting segment 4131b, and the distal end of the second reinforcement 420b is connected to the distal end of the first cutting segment 4131a. In this way, the two reinforcements 420 form an X-shaped structure that intersects each other, and the projections of the two reinforcements 420 on the same plane intersect each other.

[0065] The two reinforcement members 420 form an X-shaped structure that crosses each other, which has better structural stability in engineering mechanics and can reduce the torsional deformation of the two reinforcement members 420 along the circumferential direction. At the same time, the cutting segments 4131 of the two expansion arms 413 are respectively connected by two reinforcement members 420 that cross each other in an X-shaped structure, so that the two cutting segments 4131 have a good ability to resist deformation. When the two cutting segments 4131 are subjected to external forces, the two reinforcement members 420 of the X-shaped structure will bear and offset a part of the external forces acting on the two cutting segments 4131, thereby maintaining the rigidity of the two cutting segments 4131 and preventing them from easily being concave and deformed. At the same time, when the two cutting segments 4131 expand radially outward, the two reinforcement members 420 will also increase the force they exert on the valve tissue, so that the valve expansion device 400 has a greater expansion force acting on the valve tissue.

[0066] Embodiment 4:

[0067] refer to Figures 12 to 17 The difference between this embodiment and the first embodiment is that the valve expansion device 500 further includes at least one support member 530 .

[0068] In this embodiment, the valve expansion device 500 includes a stent 510, at least one reinforcement member 520, and at least one support member 530. The stent 510 has a proximal end 511 and a distal end 512, and the stent 510 includes an expansion arm 513, and the expansion arm 513 includes a cutting section 5131. The proximal end of the support member 530 is connected to the proximal end 511 of the stent 510, and the distal end of the support member 530 is suspended and extends in a direction away from the central axis L4 of the stent 510. The support member 530 can be used to lift the leaflets 71 of the valve, provide a supporting force for the leaflets 71, and prevent the valve expansion device 500 from deflecting under the combined action of the leaflet's own relaxation and blood flushing. The support member 530 extends from the proximal end of the stent 510 in an axial direction at a certain angle to the central axis L4 of the stent 510, and then extends outward in the radial direction of the stent 510, so that the support member 530 can be more easily recovered into the delivery device.

[0069] When the valve expansion device 500 is correctly positioned and released in the body, the distal end of the support member 530 is suspended in the air to lift or support the valve leaflets 71 of the valve. When the cutting segment 5131 gradually expands radially outward away from the central axis L4 of the stent 510, the support member 530 provides supporting force to the valve leaflets 71 through mutual contact with the surface of the valve leaflets, thereby preventing the valve leaflets 71 from slipping due to the flushing of blood flow and the swinging of the valve leaflets 71 themselves under the action of ablation cutting or mechanical cutting, thereby ensuring that the valve expansion can be completed normally.

[0070] The distal end of the support member 530 is reversely bent toward the proximal end of the stent 510, and the distal end of the support member 530 is provided with a smooth rounded corner. The reversely bent structure of the support member 530 makes the contact portion between the support member 530 and the valve leaflet 71 a smooth structure, thereby avoiding the possibility of damaging the valve leaflet 71, and at the same time avoiding the distal end of the support member 530 from hitting the inner wall of the blood vessel during the surgical operation, thereby causing blood vessel damage. The distal end of the support member 530 is a smooth rounded corner structure, which can prevent damage to the inner wall of the blood vessel.

[0071] The rod body between the proximal end and the distal end of the support member 530 may be an arc-shaped structure or a structure similar to a straight rod. The arc-shaped structure of the rod body of the support member 530 allows the support member 530 to have a certain deformation space when supporting the leaflet 71, thereby preventing the support member 530 from being easily broken. The support member 530 is set as a straight rod structure, which is more stable for supporting the leaflet 71.

[0072] In the illustrated example, there are two expansion arms 513, and there may be two support members 530, and the two support members 530 are respectively located on both sides of the plane formed by the two expansion arms 513. Preferably, the plane formed by the two support members 530 is perpendicular to the plane formed by the two expansion arms 513. Of course, there may also be four support members 530, and two support members 530 are respectively provided on both sides of the plane formed by the two expansion arms 513. When the expansion arms 513 expand radially outward away from the central axis L3 of the stent 510 to ablate and cut the adhesion sites at the junction of adjacent leaflets 71, four support members 530 will be simultaneously provided on both sides of the expansion arms 513 to jointly support the leaflets 71, so as to prevent the valve expansion device 500 from sliding and shifting under the impact of high-speed and high-pressure arterial blood flow, thereby improving the safety and effectiveness of the surgical procedure.

[0073] Two support members 530 are respectively arranged on both sides of the plane formed by the two expansion arms 513, and the four support members 530 are symmetrically distributed relative to the plane formed by the expansion arms 513. The two support members 530 on the same side of the plane formed by the two expansion arms 513 are arranged at intervals. Preferably, the angle between the two support members 530 and the angle between the support member 530 and the adjacent expansion arm 513 are both 60°. By arranging the support members 530 and the expansion arms 513 that are evenly distributed at intervals, the possibility of the support members 530 and the expansion arms 513 being entangled during the radial outward expansion of the valve expansion device 500 is avoided. At the same time, the multiple support members 530 evenly distributed along the circumference of the stent 510 also make the valve expansion device 500 have a better self-centering performance, avoiding the lateral deviation or swing of the valve expansion device 500 at the leaflet position.

[0074] The highest point of the distal end of the support member 530 in the axial direction is in the same plane as the center point of the stent 510, which is defined here as the midpoint of the line connecting the distal end and the proximal end of the stent 510. Further, the highest point of the support member 530 in the axial direction is in the same plane as the highest point of the reinforcement member 520 in the axial direction. In other words, the highest point of the support member 530 in the axial direction, the highest point of the reinforcement member 520 in the axial direction, and the center point of the stent 510 are all in the same plane.

[0075] It can be understood that after the valve expansion device 500 is completely positioned in the body, the leaflet 71 should be in the middle of the cutting segment 5131, that is, the plane where the center point of the stent 510 is located in the radial direction. In order to make the leaflet 71 in the middle of the two cutting segments 5131 under the support of the support member 530, so as to facilitate the valve expansion device 500 to perform the next step, the plane where the highest point of the support member 530 is located in the radial direction should coincide with the plane perpendicular to the axial direction of the middle part of the cutting segment 5131. At the same time, from the perspective of engineering mechanics, the plane where the highest point of the reinforcement member 520 along the axial direction is located in the radial direction coincides with the plane perpendicular to the axial direction of the middle part of the cutting segment 5131, so that when the reinforcement member 520 is subjected to the action of external force, the reinforcement member 520 can receive symmetrical forces of the same size but opposite directions, thereby preventing the stent 510 from torsional deformation.

[0076] Embodiment five:

[0077] refer to Fig.18 and Fig.19 The difference between this embodiment and the fourth embodiment is that the structure of the support member 630 is different.

[0078] In this embodiment, the valve expansion device 600 includes a stent 610, and the stent 610 has a central axis L5. The distal end of the support member 630 forks into two reverse-bent branch rods 631. The two branch rods 631 are spread out at a certain angle at the distal end of the support member 630, and at the same time reversely bend toward the proximal end of the stent 610. The connection between the two branch rods 631 is a branch point, and the branch point can be set close to the distal end of the support member 630, or close to the proximal end of the support member 630. By setting the branch rods 631, the contact points between the support member 630 and the surface of the leaflet can be increased, and multiple contact points can provide a more stable supporting capacity for the leaflet compared to a single contact point.

[0079] The valve expansion device 600 includes two support members 630, and the two support members 630 respectively include two branch rods 631. The four branch rods 631 can increase the contact points between the support members 630 and the surface of the leaflets, thereby improving the supporting capacity of the valve expansion device 600 for the leaflets.

[0080] It can be understood that the above embodiments only express the preferred implementation modes of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the patent scope of the present invention. It should be pointed out that, for ordinary technicians in this field, the above technical features can be freely combined without departing from the concept of the present invention, and several deformations and improvements can be made, which all belong to the protection scope of the present invention. Therefore, all equivalent changes and modifications made to the scope of the claims of the present invention should belong to the coverage of the claims of the present invention.

Claims

1. A valve expansion device with a reinforcement member, characterized in that: include: A stent, the stent comprising a proximal end and a distal end disposed opposite to each other in the axial direction, and at least two expansion arms connected between the proximal end and the distal end, the at least two expansion arms being spaced apart in the circumferential direction, each of the expansion arms being expandable or compressible in the radial direction of the stent, and at least one of the expansion arms being provided with a cutting portion on a side away from the other expansion arms; and At least one reinforcement member, the reinforcement member is fixedly connected between two adjacent expansion arms, the reinforcement member and the expansion arm are synchronously expanded or compressed along the radial direction of the stent, the expansion arm includes a cutting segment and two support segments respectively arranged at both ends of the cutting segment, the other end of one of the support segments is connected to the proximal end of the stent, and the other end of the other support segment is connected to the distal end of the stent, the cutting portion is arranged in the cutting segment, and the reinforcement member is fixedly connected between two adjacent cutting segments.

2. The valve expansion device according to claim 1, characterized in that: The reinforcement member includes a connecting ring and at least two connecting strips respectively connected to the connecting ring. The connecting ring is located at the central axis of the stent, and each of the connecting strips is bent and extends from the expansion arm to the connecting ring.

3. The valve expansion device according to claim 1, characterized in that: The reinforcement member includes a hollow portion, the hollow portion is located at the central axis of the bracket, and the reinforcement member is bent and extends from one of the expansion arms to the other expansion arm.

4. The valve expansion device according to claim 1, characterized in that: The reinforcing member is annular, and the connection points of the reinforcing member and each of the expansion arms are located on the same plane, and the plane is perpendicular to the central axis of the bracket.

5. The valve expansion device according to claim 4, characterized in that: The reinforcement member includes at least two V-shaped reinforcement strips connected end to end.

6. The valve expansion device according to claim 1, characterized in that: The valve expansion device comprises at least two reinforcement members, and the projections of every two reinforcement members on the same plane intersect with each other.

7. The valve expansion device according to any one of claims 1 to 6, characterized in that: The valve expansion device also includes at least one support member, the proximal end of the support member is connected to the proximal end of the stent, and the distal end of the support member is suspended and extends in a direction away from the central axis of the stent.

8. The valve expansion device according to claim 7, characterized in that: The distal end of the support member is bent in reverse direction toward the proximal end of the bracket, and a smooth rounded corner is provided at the distal end of the support member.

9. The valve expansion device according to claim 7, characterized in that: The highest point of the support member in the axial direction, the highest point of the reinforcement member in the axial direction and the center point of the bracket are all located on the same plane, and the center point of the bracket is the midpoint of the line connecting the proximal end and the distal end of the bracket.

10. A valve expansion system, characterized in that: comprising a delivery device and a valve expansion device as claimed in any one of claims 1 to 9; The conveying device includes an inner tube, an intermediate tube and an outer tube, the intermediate tube is slidably arranged in the outer tube, the inner tube is slidably arranged in the intermediate tube, the proximal end of the bracket is fixedly connected to the distal end of the intermediate tube, the distal end of the bracket can be slidably mounted on the inner tube, and a limiting member is arranged at the distal end of the inner tube.

11. The valve expansion system according to claim 10, characterized in that: The valve expansion system further comprises an energy generating device, the cutting portion is at least partially conductive, and the energy generating device is electrically connected to the cutting portion.

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