Prosthetic valves and transcatheter prosthetic valve delivery systems

Abstract

The present invention discloses an artificial valve and a transcatheter artificial valve delivery system. The artificial valve includes a valve stent; a positioning frame; a connecting assembly, including a first connecting member and a second connecting member, the first connecting member being connected to the valve stent, the second connecting member being connected to the positioning frame, and the first connecting member being slidably connected to the second connecting member; the valve stent and the positioning frame both have a radially compressed delivery state and a radially expanded implantation state, and the positioning frame can form a positioning space around the native leaflet; at least a portion of the valve stent is adapted to enter the positioning space when the positioning frame is in the implantation state, and drive the first connecting member to slide relative to the second connecting member, at least a portion of the valve stent can be expanded into the implantation state in the positioning space, and the valve stent and the positioning frame can be positioned by means of the connecting assembly. The valve stent and the positioning frame of the artificial valve are slidably connected by the first connecting member and the second connecting member, and the valve stent and the positioning frame can be effectively positioned during the implantation process.

Description

Technical Field

[0001] The present invention relates to the medical field, and further to an artificial valve and a transcatheter artificial valve delivery system. Background Art

[0002] The heart is divided into two parts, each consisting of a ventricle and an atrium. The ventricles and atria are separated by the ventricular septum and the atrial septum, respectively. Valves prevent blood from flowing back between the atria, ventricles, and arteries. The mitral valve is located between the left atrium and left ventricle, the tricuspid valve is located between the right atrium and right ventricle, the aortic valve is located between the left ventricle and the aorta, and the pulmonary valve is located between the right ventricle and the pulmonary artery.

[0003] The aforementioned valves open and close in response to the heart's contraction and relaxation, so they must be able to withstand the constant flow of blood and the compression of blood against the surrounding annulus. When the valves fail to fully close, blood regurgitation can occur. To improve blood supply, doctors sometimes recommend minimally invasive interventional surgery to place a stent.

[0004] Currently, there are problems of inaccurate positioning, low release accuracy and poor positioning stability during the implantation of valve stents, which affect the use effect of the valve stents. Summary of the Invention

[0005] In response to the above technical problems, the purpose of the present invention is to provide an artificial valve and a transcatheter artificial valve delivery system, wherein the valve stent and positioning frame of the artificial valve are slidably connected by a first connecting member and a second connecting member, and the valve stent and positioning frame can be effectively positioned during the implantation process.

[0006] In order to achieve the above object, the present invention provides an artificial valve, comprising:

[0007] valve stents;

[0008] A positioning frame, the positioning frame comprising at least three elastic arms, each of the elastic arms comprising a proximal bent section and extension rods extending from both ends of the proximal bent section to the distal end, the proximal ends of the extension rods of adjacent elastic arms being integrally connected;

[0009] A connecting assembly comprising a first connecting member and a second connecting member, wherein the first connecting member is connected to the valve support, the second connecting member is connected to the positioning frame, and the first connecting member is slidably connected to the second connecting member, and the connecting assembly further comprises a one-way limiting structure provided between the first connecting member and the second connecting member;

[0010] The valve stent and the positioning frame both have a radially compressed delivery state and a radially expanded implantation state, and the positioning frame can form a positioning space around the native valve leaflet when in the implantation state;

[0011] At least a portion of the valve stent is suitable for entering the positioning space when the positioning frame is in the implanted state, and driving the first connecting member to slide relative to the second connecting member. At least a portion of the valve stent can be expanded to the implanted state in the positioning space, and the valve stent and the positioning frame can be positioned by means of the connecting assembly. When at least a portion of the valve stent moves in a direction away from the positioning space, the one-way limiting structure can limit the relative sliding of the first connecting member and the second connecting member to limit at least a portion of the valve stent from leaving the positioning space.

[0012] In some preferred embodiments, the second connecting member is a guide rod, the proximal end of the guide rod is connected to the proximal end of the positioning frame, the distal end of the guide rod extends toward the distal end of the positioning frame, and the first connecting member is slidably connected to the guide rod.

[0013] In some preferred embodiments, the first connecting member has a sliding channel, and the guide rod is slidably mounted in the sliding channel.

[0014] In some preferred embodiments, the first connecting member is a connecting rope, one end of the connecting rope is fixed to the proximal end of the valve stent, and one end of the connecting rope away from the valve stent is knotted to form the sliding channel.

[0015] In some preferred embodiments, the one-way limiting structure is arranged at a preset position at the proximal end of the guide rod, and the one-way limiting structure allows the connecting rope to move from the distal end to the proximal end along the guide rod. During the process of the connecting rope moving from the proximal end to the distal end along the guide rod, the one-way limiting structure can abut against the connecting rope.

[0016] In some preferred embodiments, the guide rod includes a first sub-guide rod and a second sub-guide rod, the proximal ends of the first sub-guide rod and the second sub-guide rod are respectively connected to the positioning frame, and a guide space is formed between the first sub-guide rod and the second sub-guide rod; the one-way limiting structure includes a limiting rod, the limiting rod has a connecting end and a free end, the limiting rod is obliquely arranged in the guide space, and the connecting end is connected to the first sub-guide rod, the free end abuts against the second sub-guide rod, the connecting end is close to the distal end, and the free end is close to the proximal end, and the end of the connecting rope away from the valve bracket can be slidably sleeved on the second sub-guide rod.

[0017] In some preferred embodiments, the second sub-guide rod has a blocking block at a preset position, and the blocking block is located on the side of the free end close to the proximal end. During the process of the connecting rope sliding from the proximal end to the distal end of the second sub-guide rod, the blocking block can block the gap between the free end and the second sub-guide rod, preventing the end of the connecting rope from slipping out of the gap between the free end and the second sub-guide rod.

[0018] In some preferred embodiments, the proximal end of the valve stent has a fixing portion, and the end of the connecting rope away from the positioning frame is fixed to the fixing portion.

[0019] In some preferred embodiments, the proximal end of the valve stent has a threading hole, and the threading hole forms the fixing portion.

[0020] In some preferred embodiments, the proximal end of the valve stent has a first threading hole and a second threading hole arranged adjacent to each other, the connecting rope passes through the second threading hole, and the end of the connecting rope away from the positioning frame is fixed to the wall of the first threading hole; in the process of the valve stent expanding from the delivery state to the implantation state in the positioning space, the distance between the first threading hole and the second threading hole increases, the length of the connecting rope between the first threading hole and the second threading hole increases, and the length of the connecting rope between the second threading hole and the positioning frame decreases.

[0021] In some preferred embodiments, the first connecting member is a sliding block having a sliding hole. The sliding block is fixed to the proximal end of the valve stent, and the guide rod is slidably mounted in the sliding hole, which forms the sliding channel.

[0022] In some preferred embodiments, the sliding block includes a base block and an extension arm extending outward from the base block, the sliding hole is located in the extension arm, and the base block is fixedly connected to the valve support.

[0023] In some preferred embodiments, a first limiting block is provided at a preset position at the distal end of the guide rod, and a proximal end of the first limiting block is adapted to abut against the distal end of the sliding block to limit the sliding block.

[0024] In some preferred embodiments, the one-way limiting structure includes a second limiting block arranged at a preset position at the proximal end of the guide rod, the proximal radial dimension of the second limiting block is larger than the radial dimension of the sliding hole, the distal radial dimension of the second limiting block is smaller than the radial dimension of the sliding hole, the distal end and the proximal end of the second limiting block are connected by a guide slope, and the proximal end of the second limiting block has an abutment surface; after the sliding block moves toward the proximal end along the guide slope and passes over the second limiting block, the abutment surface can abut against the sliding block.

[0025] In some preferred embodiments, the guide rod is provided with a proximal hollow hole extending along the length direction at the position corresponding to the second limit block, and the guide rod is provided with a distal hollow hole extending along the length direction at the distal end corresponding to the position of the first limit block.

[0026] In some preferred embodiments, the distal end of the elastic arm has a barb extending toward the proximal end.

[0027] In some preferred embodiments, the positioning frame includes at least three elastic arms, each of which includes a proximal bending section and an extension rod extending from both ends of the proximal bending section to the distal end, and the proximal ends of the extension rods of adjacent elastic arms are integrally connected.

[0028] In some preferred embodiments, the valve stent includes a stent body that is cylindrical in the implanted state, the stent body includes a distal stent segment and a proximal stent segment, and the radial dimension of the distal stent segment is greater than the radial dimension of the proximal stent segment.

[0029] In some preferred embodiments, the stent body further comprises at least one intermediate stent segment located between the distal stent segment and the proximal stent segment, and a radial dimension of the intermediate stent segment is located between the distal stent segment and the proximal stent segment.

[0030] In some preferred embodiments, the valve stent includes a plurality of interconnected stent units, which are surrounded by a connecting hole. The valve stent also includes a skirt rod located in the connecting hole of the distal stent segment, and the preset position of the skirt rod is radially protruding outward.

[0031] In some preferred embodiments, the preset position of the skirt rod is inclined outward at an angle of 20° to 40°.

[0032] In some preferred embodiments, the skirt rod is arranged along the axial direction of the communicating hole.

[0033] In some preferred embodiments, the size of the communicating hole located at the distal end of the stent body is smaller than the size of the communicating hole located at the proximal end of the stent body.

[0034] According to another aspect of the present invention, there is further provided a transcatheter artificial valve delivery system, comprising:

[0035] The artificial valve described in any one of the above items;

[0036] The delivery mechanism includes the positioning frame for loading the artificial valve and the slender shaft of the valve support. The delivery mechanism can deliver the artificial valve to a preset position and release it.

[0037] Compared with the prior art, the artificial valve and transcatheter artificial valve delivery system provided by the present invention have at least one of the following beneficial effects:

[0038] 1. The artificial valve and transcatheter artificial valve delivery system provided by the present invention have a valve stent and a positioning frame of the artificial valve that are slidably connected by a first connector and a second connector, which can effectively position the valve stent and the positioning frame during implantation;

[0039] 2. In the artificial valve and transcatheter artificial valve delivery system provided by the present invention, the proximal end of the guide rod has an anti-slip groove or a limit block, which can limit the first connecting member and restrict the first connecting member from sliding from the proximal end to the distal end;

[0040] 3. The artificial valve and transcatheter artificial valve delivery system provided by the present invention have a proximal hollow hole at the proximal end of the guide rod and a distal hollow hole at the distal end, which can reduce the rigidity of the guide rod and facilitate bending of the guide rod;

[0041] 4. In the artificial valve and transcatheter artificial valve delivery system provided by the present invention, as the valve stent is expanded from a delivery state to an implanted state, as the distance between the valve stent and the positioning frame decreases, the length of the connecting rope between the valve stent and the positioning frame also decreases accordingly, thereby enabling better positioning of the valve stent and the positioning frame relative to each other;

[0042] 5. The artificial valve and transcatheter artificial valve delivery system provided by the present invention include a valve stent and a positioning frame used in conjunction with the valve stent. The positioning frame can be pre-delivered to the patient's heart valve to effectively and accurately position the valve stent.

[0043] 6. The artificial valve and transcatheter artificial valve delivery system provided by the present invention have a valve stent and positioning frame that can be compressed in the delivery system for delivery and expanded for implantation at the human valve. In the delivery system, the valve stent and positioning frame are placed front to back without radial overlap, thereby reducing the diameter of the delivery catheter and facilitating entry into the human body through a vascular pathway.

[0044] 7. In the artificial valve and transcatheter artificial valve delivery system provided by the present invention, since the valve stent and the positioning frame are relatively fixed only after implantation, the relative positions of the positioning frame and the human valve, and between the valve stent and the positioning frame can be adjusted during the implantation process, and the positioning frame can be completely recovered before the positioning frame is completely released. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] The preferred embodiments will be described below in a clear and understandable manner with reference to the accompanying drawings to further illustrate the above-mentioned characteristics, technical features, advantages and implementation methods of the present invention.

[0046] Figure 1 1 is a schematic diagram of the overall structure of an artificial valve according to a first preferred embodiment of the present invention;

[0047] Figure 2 yes Figure 1 Enlarged view of point a in the middle;

[0048] Figure 3 yes Figure 1 The enlarged image of point b in the middle;

[0049] Figure 4 1 is a structural schematic diagram of a modified embodiment of the artificial valve of the first preferred embodiment of the present invention;

[0050] Figure 5 1 is a schematic diagram of the three-dimensional structure of the valve stent of the artificial valve of the first preferred embodiment of the present invention located in the positioning space of the positioning frame;

[0051] Figure 6 yes Figure 5 Frontal view of;

[0052] Figure 7 yes Figure 5 A top view of

[0053] Figure 8 1 is a schematic diagram of the three-dimensional structure of the positioning frame of the artificial valve according to the first preferred embodiment of the present invention;

[0054] Figure 9 is a schematic structural diagram of an artificial valve according to a second preferred embodiment of the present invention;

[0055] Figure 10 1 is a schematic structural diagram of a second preferred embodiment of an artificial valve according to the present invention, in which the valve stent is located outside the positioning frame in an implanted state;

[0056] Figure 11 is a schematic diagram of the exploded structure of an artificial valve according to a second preferred embodiment of the present invention;

[0057] Figure 12 yes Figure 11Schematic diagram of the enlarged structure at c in the middle;

[0058] Figure 13 yes Figure 11 Schematic diagram of the enlarged structure at point d in the middle.

[0059] Description of Figure Numbers:

[0060] Valve stent 10, fixing portion 11, threading hole 110, first threading hole 111, second threading hole 112, distal stent segment 12, proximal stent segment 13, intermediate stent segment 14, stent unit 15, connecting hole 150, skirt rod 151, positioning frame 20, positioning space 21, elastic arm 22, delivery joint 23, proximal bending section 221, extension rod 222, barb 223, connecting assembly 30, first connecting member 31, sliding channel 310, connecting rope 3 11. Sliding block 312, sliding hole 3120, base block 3121, extension arm 3122, second connecting member 32, guide rod 321, first sub-guide rod 3211, second sub-guide rod 3212, blocking block 32121, limiting rod 3213, connecting end 32131, free end 32132, guide space 3210, proximal hollow hole 3214, distal hollow hole 3125, limiting block 322, guide slope 3221, abutting surface 3222. DETAILED DESCRIPTION

[0061] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the specific embodiments of the present invention will be described below with reference to the accompanying drawings. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings and other embodiments can be obtained based on these drawings without inventive work.

[0062] To simplify the drawings, only portions relevant to the invention are schematically depicted in each figure; they do not represent the actual structure of the product. Furthermore, to simplify the drawings and facilitate understanding, in some figures, only one component with the same structure or function is schematically depicted or labeled. In this document, "one" not only means "only one" but also "more than one."

[0063] It should be further understood that the term "and / or" used in this specification and the appended claims refers to and includes any and all possible combinations of one or more of the associated listed items.

[0064] It should be noted that, unless otherwise specified or limited, the terms "mounted," "connected," and "connected" should be understood broadly. For example, they can refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediary; and internal communication between two components. Those skilled in the art will understand the specific meanings of these terms in the present invention based on the specific circumstances.

[0065] In addition, in the description of the present application, the terms "first", "second", etc. are only used to distinguish the description and cannot be understood as indicating or implying relative importance.

[0066] In this application, "proximal" and "distal" refer to the relative orientation, relative position, and direction of elements or actions relative to each other from the perspective of a doctor using the medical device. Although "proximal" and "distal" are not restrictive, "proximal" generally refers to the end of the medical device that is close to the doctor during normal operation, and "distal" generally refers to the end that first enters the patient's body.

[0067] refer to Figures 1 to 13 The artificial valve provided by the preferred embodiment of the present invention is described, and the artificial valve includes a valve stent 10, a positioning frame 20, and a connecting assembly 30. The connecting assembly 30 includes a first connecting member 31 and a second connecting member 32, wherein the first connecting member 31 is connected to the valve stent 10, and the second connecting member 32 is connected to the positioning frame 20, and the first connecting member 31 is slidably connected to the second connecting member 32. The connecting assembly 30 further includes a one-way limiting structure provided between the first connecting member 31 and the second connecting member 32.

[0068] The valve stent 10 and the positioning frame 20 both have a radially compressed delivery state and a radially expanded implantation state. When the positioning frame 20 is in the implantation state, it can form a positioning space 21 around the native valve leaflet.

[0069] At least a portion of the valve stent 10 is suitable for entering the positioning space 21 when the positioning frame 20 is in the implanted state, and driving the first connecting member 31 to slide relative to the second connecting member 32. At least a portion of the valve stent 10 can be expanded into the implanted state in the positioning space 21. The valve stent 10 and the positioning frame 20 can be positioned by means of the connecting assembly 30. When at least a portion of the valve stent 10 moves in the direction of leaving the positioning space 21, the one-way limiting structure can limit the relative sliding of the first connecting member 31 and the second connecting member 32 to limit at least a portion of the valve stent 10 from leaving the positioning space 21.

[0070] Preferably, the valve stent 10 is loaded at the distal end of the delivery device relative to the positioning frame 20. During the release process, the positioning frame 20 is first delivered to a preset position and adjusted to an implanted state, and then the valve stent 10 is pulled proximally into the positioning space 21, and then the valve stent 10 is adjusted to an implanted state. In some modified embodiments, the positioning frame 20 is loaded at the distal end of the delivery device relative to the valve stent 10. During the release process, the positioning frame 20 is first delivered to a preset position and adjusted to an implanted state, and then the valve stent 10 is pushed distally into the positioning space 21, and then the valve stent 10 is adjusted to an implanted state.

[0071] During the process of implanting at least a portion of the valve stent 10 into the positioning space 21 of the positioning frame 20, the first connecting member 31 slides relative to the second connecting member 32. Whether before or after the valve stent 10 enters the positioning space 21, the connecting assembly 30 can position the valve stent 10 and the positioning frame 20.

[0072] refer to Figure 5 、 Figure 6 、 Figure 7 、 Figure 8 、 Figure 9 as well as Figure 10 Preferably, the second connecting member 32 is a guide rod 321, the proximal end of the guide rod 321 is connected to the proximal end of the positioning frame 20, and the distal end of the guide rod 321 extends toward the distal end of the positioning frame 20, and the first connecting member 31 is slidably connected to the guide rod 321. In a modified embodiment, the first connecting member 31 is the guide rod 321, and the second connecting member 32 is slidably connected to the guide rod 321. In a modified embodiment, the first connecting member 31 and the second connecting member 32 are both guide rods 321 and can slide with each other.

[0073] refer to Figure 3 and Figure 4 The first connecting member 31 has a sliding channel 310, and the guide rod 321 is slidably mounted on the sliding channel 310. The guide rod 321 passes through the sliding channel 310 and can slide relative to the sliding channel 310. The relative sliding between the first connecting member 31 and the second connecting member 32 is achieved through the cooperation between the sliding channel 310 and the guide rod 321.

[0074] refer to Figure 1The first connecting member 31 is a connecting rope 311, one end of the connecting rope 311 is fixed to the proximal end of the valve stent 10, and the end of the connecting rope 311 away from the valve stent 10 is knotted to form the sliding channel 310. Preferably, the connecting rope 311 is a flexible rope.

[0075] During the process of inserting the proximal end of the valve stent 10 into the positioning space 21 of the positioning frame 20, the end of the connecting rope 311 away from the valve stent 10 can slide along the length extension direction of the second connecting member 32. The connecting rope 311 can position the relative position between the valve stent 10 and the positioning frame 20 during the process of inserting the proximal end of the valve stent 10 into the positioning space 21 of the positioning frame 20, thereby improving the stability of the relative position relationship between the valve stent 10 and the positioning frame 20. The connecting rope 311 has a soft structure and is easy to store, and will not interfere with the valve stent 10 and the positioning frame 20 during the implantation process.

[0076] The one-way limiting structure is arranged at a preset position at the proximal end of the guide rod 321. The one-way limiting structure allows the connecting rope 311 to move from the distal end to the proximal end along the guide rod 321. During the process of the connecting rope 311 moving from the proximal end to the distal end along the guide rod 321, the one-way limiting structure can abut against the connecting rope 311.

[0077] refer to Figure 2 The guide rod 321 includes a first sub-guide rod 3211 and a second sub-guide rod 3212. The proximal ends of the first sub-guide rod 3211 and the second sub-guide rod 3212 are respectively connected to the positioning frame 20, and a guide space 3210 is formed between the first sub-guide rod 3211 and the second sub-guide rod 3212. The guide rod 321 also includes a limiting rod 3213. The limiting rod 3213 has a connecting end 32131 and a free end 32132. The limiting rod 3213 is tilted in the guide space 3210, and the connecting end 32131 is connected to the first sub-guide rod 3211, and the free end 32132 abuts against the second sub-guide rod 3212. The connecting end 32131 is close to the distal end, and the free end 32132 is close to the proximal end. The end of the connecting rope 311 away from the valve stent 10 is slidably mounted on the second sub-guide rod 3212. The limiting rod 3213 forms the one-way limiting structure.

[0078] During the process in which the end of the connecting string 311 away from the valve stent 10 moves from the distal end to the proximal end of the second sub-guide rod 3212, the connecting string 311 can push the free end 32132 to move away from the second sub-guide rod 3212 and pass through the gap between the free end 32132 and the second sub-guide rod 3212. During the process in which the end of the connecting string 311 away from the valve stent 10 moves from the proximal end to the distal end of the second sub-guide rod 3212, the limiting rod 3213 can limit the connecting string 311 to prevent the connecting string 311 from sliding from the proximal end to the distal end of the second sub-guide rod 3212.

[0079] Furthermore, a blocking block 32121 is provided at a preset position on the second sub-guide rod 3212, and is located on the proximal side of the free end 32132. As the connecting rope 311 slides from the proximal end to the distal end of the second sub-guide rod 3212, the blocking block 32121 can block the gap between the free end 32132 and the second sub-guide rod 3212, thereby preventing the end of the connecting rope 311 from sliding out of the gap between the free end 32132 and the second sub-guide rod 3212.

[0080] In a modified embodiment, the proximal end of the guide rod 321 is preset with an anti-slip groove (not shown in the figure), the opening of the anti-slip groove is close to the proximal end, and the bottom of the groove is close to the distal end, and the anti-slip groove forms the one-way limiting structure. When the end of the connecting rope 311 away from the valve stent 10 moves from the distal end to the proximal end along the second connecting member 32, the end of the connecting rope 311 away from the valve stent 10 enters the anti-slip groove. When the valve stent 10 moves distally relative to the positioning frame 20, the end of the connecting rope 311 away from the valve stent 10 abuts against the bottom of the anti-slip groove to limit the end of the connecting rope 311 away from the valve stent 10, thereby preventing the valve stent 1 from moving distally relative to the positioning frame 20.

[0081] refer to Figure 3 and Figure 4 The proximal end of the valve stent 10 is provided with a fixing portion 11, and the end of the connecting rope 311 away from the positioning frame 20 is fixed to the fixing portion 11. Preferably, the proximal end of the valve stent 10 has a threading hole 110, and the threading hole 110 forms the fixing portion 11. The end of the connecting rope 311 away from the positioning frame 20 passes through the threading hole 110 and is fixed to the side wall of the threading hole 110. In some modified embodiments, the protrusion or groove at the proximal end of the valve stent 10 forms the fixing portion 11. As long as the purpose of fixing the connecting rope 311 can be achieved, the specific form of the fixing portion 11 should not constitute a limitation.

[0082] The proximal end of the valve stent 10 has a first threading hole 111 and a second threading hole 112 arranged adjacent to each other. The connecting rope 311 passes through the second threading hole 112, and the end of the connecting rope 311 away from the positioning frame 20 is fixed to the first threading hole 111. During the process of the valve stent 10 expanding from the delivery state to the implantation state in the positioning space 21, the distance between the first threading hole 111 and the second threading hole 112 increases, the length of the connecting rope 311 between the first threading hole 111 and the second threading hole 112 increases, and the length of the connecting rope 311 between the second threading hole 112 and the positioning frame 20 decreases.

[0083] During the process of the valve stent 10 expanding from the delivery state to the implantation state, as the distance between the valve stent 10 and the positioning frame 20 decreases, the length of the connecting rope 311 between the valve stent 10 and the positioning frame 20 also decreases accordingly, thereby better positioning the relative position between the valve stent 10 and the positioning frame 20.

[0084] Preferably, the number of the second connecting members 32 implemented as guide rods 321 and the number of the first connecting members 31 implemented as connecting ropes 31 are respectively three, and they are evenly distributed. It is understood that in some variations, the number of the connecting assemblies 30 can also be one, two, four, or more, and the number of the connecting assemblies 30 should not constitute a limitation of the present application.

[0085] refer to Figure 9 、 Figure 10 、 Figure 11 as well as Figure 13 In another preferred embodiment, the first connecting member 31 is a sliding block 312 having a sliding hole 3120. The sliding block 312 is fixed to the proximal end of the valve stent 10, and the guide rod 321 is slidably mounted in the sliding hole 3120. The sliding hole 3120 forms the sliding channel 310. In a modified embodiment, a sliding groove on the side of the sliding block 312 forms the sliding channel 310.

[0086] Furthermore, the sliding block 312 includes a base block 3121 and an extension arm 3122 extending outward from the base block 3121 , the sliding hole 3120 is located in the extension arm 3122 , and the base block 3121 is fixedly connected to the valve support 10 .

[0087] The guide rod 321 is provided with a limit block 322 at the distal and proximal preset positions, respectively. The distal limit block is a first limit block, and the proximal limit block is a second limit block. The second limit block forms the one-way limit structure. The proximal radial dimension of the limit block 322 is larger than the radial dimension of the sliding hole 3120, while the distal radial dimension of the limit block 322 is smaller than the radial dimension of the sliding hole 3120. The distal and proximal ends of the limit block 322 are connected by a guide slope 3221. The proximal end of the limit block 322 has an abutment surface 3222. After the sliding block 312 moves toward the proximal end along the guide slope 3221 and passes over the limit block 322, the abutment surface 3222 can abut against the sliding block 312 to limit the sliding block 312 from sliding from the proximal end to the distal end.

[0088] refer to Figure 11 The proximal end of the guide rod 321 has a proximal hollow hole 3214 extending along the length direction at the position corresponding to the second limit block, and the distal end of the guide rod 321 has a distal hollow hole 3125 extending along the length direction at the position corresponding to the first limit block. The proximal hollow hole 3214 and the distal hollow hole 3125 can reduce the rigidity of the guide rod 321, allowing the guide rod to radially contract and pass through the sliding hole 3120 when the sliding block 312 passes over the first limit block and the second limit block. This facilitates the bending of the guide rod 321 when the valve stent 10 is implanted in the positioning space 21 of the positioning frame 20, thereby preventing the guide rod 21 from breaking. In some modified embodiments, the proximal hollow hole 3214 and the distal hollow hole 3125 are connected.

[0089] refer to Figure 8 Specifically, the positioning frame 20 includes at least three elastic arms 22, each of which includes a proximal bent section 221 and extension rods 222 extending distally from both ends of the proximal bent section 221. The proximal ends of the extension rods 222 of adjacent elastic arms 22 are integrally connected, and the second connecting member 32 is connected to the proximal bent section 221 of the elastic arm 22. In some modified embodiments, the second connecting member 32 can also be connected to the extension rod 222 of the positioning frame 20. The specific location where the second connecting member 32 is connected to the positioning frame 20 should not constitute a limitation of the present application.

[0090] Furthermore, the distal end of the elastic arm 22 has a barb 223 extending toward the proximal end. When the positioning frame 20 is expanded to the implanted state, the barb 223 can contact human tissue, thereby improving the implantation stability of the positioning frame 20.

[0091] refer to Figure 11The valve stent 10 is cylindrical in the implanted state and includes a stent body having a distal stent segment 12 and a proximal stent segment 13. The distal stent segment 12 has a larger radial dimension than the proximal stent segment 13. During use, the distal stent segment 12, with its larger radial dimension, can more fully contact human heart tissue, effectively reducing the risk of paravalvular leakage.

[0092] The stent body further comprises at least one intermediate stent segment 14 located between the distal stent segment 12 and the proximal stent segment 13, wherein the radial dimension of the intermediate stent segment 14 is located between the distal stent segment 12 and the proximal stent segment 13. In some variations, the intermediate stent segment 14 is configured to protrude outward.

[0093] The valve stent 10 further includes a sealing membrane sutured to the stent body and a bovine pericardial leaflet disposed in the inner space of the stent body.

[0094] Compared to the proximal stent segment 13, the intermediate stent segment 14 has a larger radial dimension, which can increase the internal surface area of ​​the intermediate stent segment 14, thereby increasing the installation area of ​​the bovine pericardial valve leaflets and reducing the risk of leaflet edge breakage. The multi-stage structural design of the valve stent 10 can increase the friction between the valve stent 10 and human tissue, thereby improving implant stability.

[0095] The stent body includes a plurality of interconnected stent units 15, which surround and form a communication hole 150. The communication hole 150 connects the interior space of the stent body with the exterior space. In other words, the stent body of the valve stent 10 is a grid-like structure.

[0096] refer to Figure 11 In one variant embodiment, the stent body further includes a skirt rod 151 positioned within the communicating hole 150 of the distal stent segment 12. The skirt rod 151 is positioned radially outward. During use, the radially outwardly protruding skirt rod 151 ensures sufficient contact with human cardiac tissue, effectively reducing the risk of paravalvular leakage. Preferably, the skirt rod 151 is tilted outward at an angle of 20°-40°.

[0097] Preferably, the skirt rod 151 is arranged along the axial direction of the communicating hole 150 , both ends of the skirt rod 151 are fixed to the wall of the communicating hole 150 , and the middle of the skirt rod 151 protrudes radially outward.

[0098] Furthermore, the size of the connecting hole 150 located at the distal end of the stent body is smaller than the size of the connecting hole 150 located at the proximal end of the stent body, which can increase the sealing effect of the distal end of the stent body and further reduce the risk of paravalvular leakage.

[0099] refer to Figure 1 The positioning frame 20 and the valve stent 10 are both provided with a delivery connector 23 for connecting to a delivery mechanism. The operator can operate the delivery mechanism to transport the positioning frame 20 and the valve stent 10 to a preset position and release them.

[0100] Preferably, the delivery connector 23 of the positioning frame 20 and the valve stent 10 are both located at the proximal end. In some variations, the delivery connector 23 of the positioning frame 20 and the valve stent 10 can also be located at the distal end or in the middle. As long as the delivery requirements can be met, the location of the delivery connector 23 should not constitute a limitation to the present application.

[0101] According to another aspect of the present invention, the present invention further provides a transcatheter artificial valve replacement system, comprising the artificial valve and delivery mechanism described in the above embodiment. The delivery mechanism comprises a slender shaft of the positioning frame 20 and the valve stent 10 for loading the artificial valve, and the delivery mechanism is capable of delivering the artificial valve to a preset position and releasing it. The slender shaft of the delivery mechanism has a clamp that is adapted to the delivery connector 23 and can clamp the delivery connector 23. When the positioning frame 20 and the valve stent 10 of the artificial valve are delivered to the preset position, the clamp can release the delivery connector 23 and release the artificial valve.

[0102] It should be noted that the above embodiments can be freely combined as needed. The above are only preferred embodiments of the present invention. It should be pointed out that those skilled in the art can make several improvements and modifications without departing from the principles of the present invention, and such improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. An artificial valve, characterized in that include: valve stents; Positioning frame; A connecting assembly comprising a first connecting member and a second connecting member, wherein the first connecting member is connected to the valve support, the second connecting member is a guide rod, the proximal end of the guide rod is connected to the proximal end of the positioning frame, and the distal end of the guide rod extends toward the distal end of the positioning frame, the first connecting member is slidably connected to the guide rod, and the connecting assembly further comprises a one-way limiting structure provided between the first connecting member and the second connecting member; The valve stent and the positioning frame both have a radially compressed delivery state and a radially expanded implantation state, and the positioning frame can form a positioning space around the native valve leaflet when in the implantation state; At least a portion of the valve stent is suitable for entering the positioning space when the positioning frame is in the implanted state, and driving the first connecting member to slide relative to the second connecting member. At least a portion of the valve stent can be expanded to the implanted state in the positioning space, and the valve stent and the positioning frame can be positioned by means of the connecting assembly. When at least a portion of the valve stent moves in a direction away from the positioning space, the one-way limiting structure can limit the relative sliding of the first connecting member and the second connecting member to limit at least a portion of the valve stent from leaving the positioning space.

2. The artificial valve according to claim 1, characterized in that The first connecting member has a sliding channel, and the guide rod is slidably installed in the sliding channel.

3. The artificial valve according to claim 2, characterized in that The first connecting member is a connecting rope, one end of which is fixed to the proximal end of the valve stent, and one end of the connecting rope away from the valve stent is knotted to form the sliding channel.

4. The artificial valve according to claim 3, characterized in that The one-way limiting structure is arranged at a preset position at the proximal end of the guide rod. The one-way limiting structure allows the connecting rope to move from the distal end to the proximal end along the guide rod. During the process of the connecting rope moving from the proximal end to the distal end along the guide rod, the one-way limiting structure can abut against the connecting rope.

5. The artificial valve according to claim 4, characterized in that The guide rod includes a first sub-guide rod and a second sub-guide rod, the proximal ends of the first sub-guide rod and the second sub-guide rod are respectively connected to the positioning frame, and a guide space is formed between the first sub-guide rod and the second sub-guide rod; the one-way limiting structure includes a limiting rod, the limiting rod has a connecting end and a free end, the limiting rod is tilted in the guide space, and the connecting end is connected to the first sub-guide rod, the free end abuts against the second sub-guide rod, the connecting end is close to the distal end, and the free end is close to the proximal end, and the end of the connecting rope away from the valve bracket can be slidably sleeved on the second sub-guide rod.

6. The artificial valve according to claim 5, characterized in that The second sub-guide rod has a blocking block at a preset position, and the blocking block is located on the side of the free end close to the proximal end. During the process of the connecting rope sliding from the proximal end to the distal end of the second sub-guide rod, the blocking block can block the gap between the free end and the second sub-guide rod, preventing the end of the connecting rope from slipping out of the gap between the free end and the second sub-guide rod.

7. The artificial valve according to claim 3, characterized in that The proximal end of the valve stent is provided with a fixing portion, and one end of the connecting rope away from the positioning frame is fixed to the fixing portion.

8. The artificial valve according to claim 7, characterized in that The proximal end of the valve stent is provided with a threading hole, and the threading hole forms the fixing portion.

9. The artificial valve according to claim 8, characterized in that The proximal end of the valve stent has a first threading hole and a second threading hole arranged adjacent to each other, the connecting rope passes through the second threading hole, and the end of the connecting rope away from the positioning frame is fixed to the wall of the first threading hole; in the process of the valve stent expanding from the delivery state to the implantation state in the positioning space, the distance between the first threading hole and the second threading hole increases, the length of the connecting rope between the first threading hole and the second threading hole increases, and the length of the connecting rope between the second threading hole and the positioning frame decreases.

10. The artificial valve according to claim 2, characterized in that The first connecting member is a sliding block having a sliding hole. The sliding block is fixed to the proximal end of the valve support. The guide rod is slidably mounted in the sliding hole. The sliding hole forms the sliding channel.

11. The artificial valve according to claim 10, characterized in that The sliding block includes a base block and an extension arm extending outward from the base block. The sliding hole is located in the extension arm. The base block is fixedly connected to the valve support.

12. The artificial valve according to claim 10, characterized in that A first limiting block is provided at a preset position at the distal end of the guide rod, and a proximal end of the first limiting block is adapted to abut against the distal end of the sliding block to limit the sliding block.

13. The artificial valve according to claim 12, characterized in that The one-way limiting structure includes a second limiting block arranged at a preset position at the proximal end of the guide rod, the proximal radial dimension of the second limiting block is larger than the radial dimension of the sliding hole, the distal radial dimension of the second limiting block is smaller than the radial dimension of the sliding hole, the distal end and the proximal end of the second limiting block are connected by a guide slope, and the proximal end of the second limiting block has an abutment surface; after the sliding block moves proximally along the guide slope and passes over the second limiting block, the abutment surface can abut against the sliding block.

14. The artificial valve according to claim 13, characterized in that The guide rod is provided with a proximal hollow hole extending along the length direction at a position corresponding to the second limiting block, and the guide rod is provided with a distal hollow hole extending along the length direction at a distal end corresponding to a position of the first limiting block.

15. The artificial valve according to claim 1, characterized in that The positioning frame includes at least three elastic arms, each of which includes a proximal bending section and extension rods extending from both ends of the proximal bending section to the distal end, and the proximal ends of the extension rods of adjacent elastic arms are integrally connected.

16. The artificial valve according to claim 15, characterized in that The distal end of the elastic arm is provided with a barb extending toward the proximal end.

17. The artificial valve according to claim 1, characterized in that The valve stent comprises a stent body which is cylindrical in the implanted state. The stent body comprises a distal stent segment and a proximal stent segment. The radial dimension of the distal stent segment is greater than the radial dimension of the proximal stent segment.

18. The artificial valve according to claim 17, characterized in that The stent body further includes at least one intermediate stent segment located between the distal stent segment and the proximal stent segment, and a radial dimension of the intermediate stent segment is located between the distal stent segment and the proximal stent segment.

19. The artificial valve according to claim 17, characterized in that The valve stent includes a plurality of mutually connected stent units, which are surrounded by a connecting hole. The valve stent also includes a skirt rod located in the connecting hole of the distal stent segment, and the preset position of the skirt rod is radially protruding outward.

20. The artificial valve according to claim 19, characterized in that The preset position of the skirt rod is inclined outward at an angle of 20° to 40°.

21. The artificial valve according to claim 19, characterized in that The skirt rod is arranged along the axial direction of the communicating hole.

22. The artificial valve according to claim 19, characterized in that The communicating hole at the distal end of the stent body has a smaller size than the communicating hole at the proximal end of the stent body.

23. A transcatheter artificial valve delivery system, characterized in that: include: The artificial valve according to any one of claims 1 to 22; The delivery mechanism includes the positioning frame for loading the artificial valve and the slender shaft of the valve support. The delivery mechanism can deliver the artificial valve to a preset position and release it.

Images