Artificial heart valve and delivery device

Abstract

The present application discloses an artificial heart valve and a delivery device. The artificial heart valve includes a stent and a valve. The stent is cylindrical and has relative compressed and released states according to its radial deformation. The interior of the stent is a blood flow channel. The valve is connected within the stent to open or close the blood flow channel. It is characterized in that an anchoring arm for interacting with the native tissue of the lesion is connected to the stent. The anchoring arm in the compressed state adheres to the outer peripheral wall of the stent, and the anchoring arm in the released state turns upwards towards the outside in the radial direction of the stent. The two ends of the stent in its own axial direction are opposite pre-release ends and post-release ends. A connection structure for cooperating with the delivery device is provided at the pre-release end of the stent. The connection structure is used to restrict the release of the pre-release end to be later than the release of the anchoring arm. The present application further optimizes the stent structure and takes into account both delivery and release positioning.

Description

Technical Field

[0001] This application relates to the field of medical devices, particularly to artificial heart valves used in interventional procedures and corresponding delivery devices. Background Art

[0002] The technology of artificial heart valve replacement is a revolutionary breakthrough in heart valve treatment technology with broad prospects. With economic development and population aging, the incidence of senile calcific aortic valve disease (CAVD) shows an upward trend, becoming the cardiovascular disease second only to coronary heart disease and hypertension.

[0003] Currently, transcatheter bioprosthesis implantation is the main method for treating heart valve diseases. First, the artificial heart valve is compressed into a delivery device, and the delivery device transports the valve through blood vessels to the diseased part of the heart, and then the artificial heart valve is released to replace the diseased native valve. Currently developed heart valves include balloon-expandable valves or self-expandable valves. An artificial heart valve replacement device generally includes a reticular stent made of a shape memory metal material and a unidirectionally open valve sewn inside the stent. The stent expands to fit the diseased location as much as possible, but there will still be varying degrees of paravalvular leakage and peripheral regurgitation.

[0004] In order to further reduce paravalvular leakage and peripheral regurgitation and facilitate precise positioning during the release of interventional instruments, in some existing technologies, pointed anchor arms that can clamp native tissues (such as the aortic valve or mitral valve) are provided on the outer periphery of the stent. Before the stent is fully released, the anchor arms are pre-released and positioned, and then the stent is fully released. The setting of the anchor arms plays a pre-positioning role on the one hand, and can also make the stent better fit the surrounding native tissues, reducing paravalvular leakage.

[0005] Since the anchor arms need to be released before the stent, the delivery device will be relatively complicated. For example, a double-layer outer sheath is used for layer-by-layer release, or a two-stage sheath is used, that is, the proximal and distal ends are released separately. However, since the anchor arms are located on the outer periphery of the stent during loading, when the stent is released, there will inevitably be a section of the stent in a semi-released state, which has an adverse impact on the positioning and posture of the anchor arms, and in severe cases, there is a risk of anchor arm misalignment or failure. Summary of the Invention

[0006] Aiming at the problems of the prior art, this application provides an artificial heart valve with anchor clamp arms and a corresponding delivery device, and improvements are made to the loading and release of the stent and the anchor arms.

[0007] The artificial heart valve of the present application includes a stent and a valve. The stent is cylindrical and has a relative compressed state and a released state according to its radial deformation. The inside of the stent is a blood flow channel. The valve is connected inside the stent to open or close the blood flow channel. An anchoring arm for interacting with the native tissue of the lesion is connected to the stent. In the compressed state, the anchoring arm adheres to the outer peripheral wall of the stent, and in the released state, the anchoring arm turns outward in the radial direction of the stent.

[0008] Both ends of the stent in its own axial direction are a relatively first-release end and a later-release end. A connection structure for cooperating with the delivery device is provided at the first-release end of the stent. The connection structure is used to restrain the release of the first-release end to be later than the release of the anchoring arm.

[0009] The following also provides several optional ways, but it is not an additional limitation to the above overall solution, but only a further supplement or preference. Without technical or logical contradictions, each optional way can be combined with the above overall solution alone, or multiple optional ways can be combined with each other.

[0010] Optionally, the first-release end of the stent includes a plurality of pointed corner parts distributed circumferentially. The connection structure is a plurality of wire passing holes distributed circumferentially along the stent, and each pointed corner part is provided with the wire passing hole.

[0011] Optionally, the stent is woven with metal wires, and at least one section of at least one metal wire extends out of the outer periphery of the stent and forms the anchoring arm after detouring; or

[0012] The stent together with the anchoring arm is integrally cut from a metal pipe; or

[0013] The stent is cut from a metal pipe, and the anchoring arm is welded and fixed to the stent.

[0014] Optionally, the anchoring arm is a frame structure, including a root part connected to the stent and a head part far from the stent in the released state. The shape gradually converges from the root part to the head part, and the outer edge of the head part is an arc structure.

[0015] The present application also provides a delivery device for loading and delivering the artificial heart valve of the present application. The delivery device has a relative distal end and proximal end. The delivery device includes a sheath core and an outer sheath tube slidably arranged on the outer periphery of the sheath core. The proximal ends of both the sheath core and the outer sheath tube are connected with a handle for driving their relative movement. An installation head for cooperating with the later-release end of the artificial heart valve is fixed on the sheath core. A first wire is arranged inside the sheath core. One end of the first wire passes through the sheath core and cooperates with the connection structure of the artificial heart valve, and the other end of the first wire extends proximally inside the sheath core and is controlled by the handle.

[0016] Optionally, a fixing sleeve is provided on the outer periphery of the distal part of the sheath core. A guiding hole for the first pulling wire to extend is penetrated between the inner wall of the sheath core and the outer wall of the fixing sleeve. The extending direction of the guiding hole is arranged obliquely with respect to the axis of the sheath core;

[0017] The guiding hole is a hole inner edge at the inner wall of the sheath core and a hole outer edge at the outer wall of the fixing sleeve. The hole outer edge has a smooth flared structure.

[0018] Optionally, the conveying device further includes a first wire loop that sequentially passes through each wire passing hole along the circumferential direction of the bracket. The first pulling wire is connected to the first wire loop and is pulled with at least two parts of the first wire loop;

[0019] The first pulling wire is directly connected to the handle or is connected to the handle via a first pipe fitting slidably installed in the sheath core.

[0020] Optionally, the mating manner between the rear release end of the artificial heart valve and the mounting head is as follows:

[0021] The rear release end of the artificial heart valve and the mounting head are mutually engaged through a shape-matching positioning structure. In the compressed state, the positioning structure restricts the axial position of the bracket, and in the released state, the positioning structure is disengaged; or

[0022] The mounting head is provided with a threading hole. The conveying device further includes a second pulling wire connected to the rear release end of the artificial heart valve. The proximal end of the second pulling wire is coupled to the handle via the threading hole.

[0023] Optionally, a second pipe fitting is slidably installed in the radial gap between the sheath core and the outer sheath tube on the proximal side of the mounting head. The proximal end of the second pulling wire is connected to the distal end of the second pipe fitting via the threading hole, and the proximal end of the second pipe fitting is connected to the handle.

[0024] Optionally, the conveying device further includes a second wire loop that passes through the rear release end of the bracket along the circumferential direction of the bracket. The second pulling wire is connected to the second wire loop and is pulled with at least two parts of the second wire loop.

[0025] The artificial heart valve and the conveying device of the present application improve the stent structure with anchoring arms, use a single-layer and single-segment outer sheath tube for loading and releasing, as much as possible avoid the overall radial size of the instrument from being too large, ensure flexibility, and in addition, the stent can still be kept in a compressed state after the anchoring arms are released, which is convenient for controlling the posture of the anchoring arms and accurate positioning. Description of the Drawings

[0026] Figure 1Schematic diagram of an artificial heart valve according to an embodiment of the present application applied to the mitral valve position;

[0027] Figure 2 Schematic diagram of an artificial heart valve according to an embodiment of the present application applied to the aortic valve position;

[0028] Figure 3 Schematic structural diagram of an artificial heart valve according to another embodiment of the present application applied to the aortic valve position;

[0029] Figure 4 Schematic structural diagram of an artificial heart valve according to an embodiment of the present application;

[0030] Figure 5 is Figure 4 Principle schematic diagram of the stent in

[0031] Figure 6 is Figure 5 Principle schematic diagram after the first release end of the stent in

[0032] Figure 7 Schematic structural diagram of an artificial heart valve according to another embodiment of the present application;

[0033] Figure 8 Schematic structural diagram of an artificial heart valve according to another embodiment of the present application;

[0034] Figure 9 Schematic structural diagram of an artificial heart valve according to another embodiment of the present application;

[0035] Figure 10 is Figure 9 Principle schematic diagram of the stent in

[0036] Figure 11 is Figure 10 Principle schematic diagram after the first release end of the stent in

[0037] Figure 12 is Figure 5 Schematic diagram of the artificial heart valve in

[0038] Figure 13 is Figure 10 Schematic diagram of the artificial heart valve in

[0039] Figure 14 Schematic diagram of an artificial heart valve according to an embodiment of the present application in a compressed state loaded on a delivery device;

[0040] Figure 15 is Figure 14 Schematic diagram of only the anchoring arm release of the artificial heart valve in

[0041] Figure 16 Schematic diagram of the further release of the first release end of the artificial heart valve stent in Figure 15 ;

[0042] Figure 17 Schematic diagram of the complete release of the artificial heart valve in Figure 16 ;

[0043] Figure 18 Schematic diagram of the structure of the release end of the transformed stent relative to Figure 17 ;

[0044] Figure 19 Schematic diagram of the cooperation between the stent end and the wire loop.

[0045] The descriptions of the reference numerals in the figure are as follows:

[0046] 100, mitral valve;

[0047] 200, aortic valve;

[0048] 300, artificial heart valve; 310, stent; 320, anchoring arm; 330, wire passing hole; 340, connecting ear; 350, first release end; 360, second release end; 370, wire passing hole; 380, valve;

[0049] 400, delivery device; 410, sheath core; 411, fixing sleeve; 412, guiding hole; 413, outer edge of the hole; 414, inner edge of the hole; 420, outer sheath tube; 430, guiding head; 440, first pull wire; 441, first wire loop; 450, first pipe fitting; 460, mounting head; 461, clamping groove; 462, threading hole; 470, second pull wire; 480, second pipe fitting. Detailed implementation manners

[0050] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments in the present application without creative efforts shall fall within the protection scope of the present application.

[0051] It should be noted that when a component is referred to as being "connected" to another component, it can be directly connected to the other component or there may also be an intermediate component. When a component is considered to be "disposed on" another component, it can be directly disposed on the other component or there may be an intermediate component at the same time.

[0052] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terms used in the description of this application herein are for the purpose of describing specific embodiments only and are not intended to limit this application. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0053] See Figures 1 - 13 An embodiment of this application provides an artificial heart valve 300, including a stent 310 and a valve 380. The stent 310 is cylindrical and has a relative compressed state and a released state according to its own radial deformation. The inside of the stent 310 is a blood flow channel. The valve 380 is connected inside the stent 310 to open or close the blood flow channel. An anchoring arm 320 for interacting with the native tissue of the lesion is connected to the stent 310. In the compressed state, the anchoring arm 320 adheres to the outer peripheral wall of the stent 310, and in the released state, the anchoring arm 320 turns outwards towards the outside of the radial direction of the stent 310.

[0054] At both ends of the stent 310 in its own axial direction are opposite first-release ends 350 and second-release ends 360. A connection structure for cooperating with the delivery device 400 is provided at the first-release end 350 of the stent 310, and the connection structure is used to restrain the release of the first-release end 350 to be later than the release of the anchoring arm 320.

[0055] According to different lesion sites, the stent 310 can adopt matching shape characteristics. For example, as shown in the figure, it can be implanted into the mitral valve 100, or the aortic valve 200, etc. According to different intervention paths and release methods, its first-release end 350 and second-release end 360 can be relatively interchanged. For example Figure 3 When implanted into the aortic valve 200, when intervening from the aortic arch, the first-release end 350 is generally the lower end of the stent (in the Figure 3 orientation), and when intervening from the apex of the heart, the first-release end 350 is generally the upper end of the stent (in the Figure 3 orientation). Generally speaking, the end far from the operator along the intervention path is the distal end, and the end towards the operator is the proximal end.

[0056] The materials of the stent 310 and the valve 380 can adopt existing technologies. For example, the stent 310 can be made of metal wire braiding or pipe cutting. In order to facilitate compression loading, a grid structure with multiple perforations is adopted, but the shape or arrangement of the grid is not strictly required. The valve 380 is sewn inside the stent 310 to control the one-way opening of the blood flow channel. A two-leaf valve or a three-leaf valve can be selected according to the physiological characteristics of the lesion site. In addition, the inner peripheral wall or the outer peripheral wall of the stent 310 can also be covered with a film according to needs.

[0057] As for the anchoring arm 320 itself, it can adopt a strip-shaped, sheet-shaped or frame structure, and is made of a pre-shapable elastic material. The anchoring arm 320 is released prior to the stent 310 and can be pre-positioned in the surrounding native tissue first. After the stent 310 is released, it cooperates with the stent 310 to further clamp or engage the native tissue, ensuring the precise overall posture of the artificial heart valve 300 and reducing the occurrence of paravalvular leakage.

[0058] Generally, the rear release end 360 of the stent 310 is the last to break free from the restraint of the delivery device 400. Before that, the anchoring arm 320 has been released. This application focuses on setting a connection structure for the front release end 350 of the stent 310 that cooperates with the delivery device 400, which can ensure that the front release end 350 is in a compressed state before and during the release of the anchoring arm 320, and naturally the rear release end 360 is also in a compressed state. The delivery device 400 in this application uses a single-layer outer sheath tube, and only controls the release timing of the front release end 350 through the connection structure, which can avoid the increase in the outer diameter of the instrument compared with the double-layer sheath tube.

[0059] Some existing technologies use a two-stage outer sheath tube to first release the anchoring arm and a small part of the stent, and then release the rest of the stent. However, even the release of a small part of the stent will cause a change in the angle of the anchoring arm, which is not conducive to precise positioning. When the anchoring arm is released in this application, it can ensure that both ends of the stent are in a compressed state, improving the positioning effect.

[0060] The following some embodiments provide different solutions for the specific form of the anchoring arm 320 and its connection relationship with the stent 310.

[0061] In one embodiment, the stent 310 is made of braided metal wires, and at least one section of one of the metal wires extends out of the outer periphery of the stent 310 and forms the anchoring arm after being bent.

[0062] In one embodiment, the stent 310 and the anchoring arm 320 are integrally cut from a metal pipe.

[0063] In one embodiment, the stent 310 is cut from a metal pipe, and the anchoring arm 320 is welded and fixed to the stent 310.

[0064] When using the integral cutting method, continuous hollow parts will be generated at the anchoring arm 320, which may slightly affect the overall strength of the stent 310. Currently, the braided structure can avoid this problem. The number of anchoring arms 320 can be 2, 3 or 4 and are evenly arranged circumferentially.

[0065] In one embodiment, the anchoring arm 320 is a frame structure, including a root connected to the stent 310 and a head far from the stent 310 in the released state. The shape gradually converges from the root to the head, and the outer edge of the head is an arc structure.

[0066] The circumferential span of the root of the anchoring arm 320, that is, the corresponding central angle, can be 5 to 180 degrees. The smaller the degree, the more obvious the trend of the shape gradually converging. Preferably, it is 30 to 90 degrees. In addition, considering the outer edge shape of the head, positioning and safety can be taken into account.

[0067] In order to ensure the control effect on the first release end 350, in one embodiment, the first release end 350 of the stent 310 includes a plurality of sharp corner portions distributed circumferentially, and the connecting structure is a plurality of wire passing holes 330 distributed circumferentially along the stent 310. Each sharp corner portion is provided with a wire passing hole 330.

[0068] When the stent 310 adopts a grid structure, the sharp corner portion is the vertex portion of the grid at the first release end 350. Each sharp corner portion is provided with a wire passing hole 330, which can synchronously control each part of the first release end 350 by using the wire in the conveying device, facilitating the balanced change of the attitude of each part and avoiding the adverse impact on the positioning after individual sharp corners turn outwards.

[0069] Figures 4 - 6 It shows the release change of the anchoring arm 320 and the first release end 350. Figures 9 - 11 Similarly, there are only slight differences in the application scenarios and the detailed structure of the stent. The anchoring arm 320 is released when the stent 310 is in a compressed state, and can be pre-positioned to the surrounding native tissue as shown in Figure 12 、 Figure 13 . In order to control the second release end, generally, the restraint of the outer sheath tube in the conveying device can be utilized. The stent 310 is provided with connecting ears 340 that cooperate with the conveying device or also provided with wire passing holes 370, that is, adopting a wire control method similar to that of the first release end 350.

[0070] Combined with Figures 14 - 19 , in some embodiments of the present application, a conveying device 400 is also provided for loading and conveying the artificial heart valve 300 of the above embodiments. The conveying device 400 has opposite distal and proximal ends. The conveying device 400 includes a sheath core 410 and an outer sheath tube 420 slidably arranged on the outer periphery of the sheath core 410. The proximal ends of both the sheath core 410 and the outer sheath tube 420 are connected with a handle (not shown in the figure) for driving their relative movement. An installation head 460 that cooperates with the second release end 360 of the artificial heart valve 300 is fixed on the sheath core 410. A first wire 440 is arranged inside the sheath core 410. One end of the first wire 440 passes through the sheath core 410 and cooperates with the connecting structure of the artificial heart valve 300. The other end of the first wire 440 extends proximally inside the sheath core 410 and is controlled by the handle.

[0071] The sheath core 410 itself is tubular and can be in one piece or in multiple segments butt-jointed. The distal end of the sheath core 410 is provided with a guiding head 430 for threading in the body. The proximal ends of the sheath core 410 and the outer sheath tube 420 are both connected to the handle. At the handle, methods such as gear meshing and electric push rods can be used to drive the relatively moving components. Of course, it can also be implemented in combination with many existing technologies.

[0072] One end of the first pull wire 440 directly or indirectly pulls each wire-passing hole 330 on the stent 310, and the other end is directly or indirectly connected to the corresponding driving component in the handle. The release timing of the first release end 350 of the stent 310 can be controlled via the pull wire through the handle. For the first pull wire 440, it can be one or multiple parallel ones, and synthetic fibers or metal wires can be used. Appropriate materials and wire diameters are selected on the premise of ensuring the pulling strength. When a guide wire needs to be threaded inside the sheath core 410, the wire diameter of the first pull wire 440 should leave at least a gap in the sheath core 410 for the guide wire to pass through.

[0073] In order to avoid excessive stress at the turning part where the first pull wire 440 passes out of the sheath core 410, in one embodiment, the outer periphery of the distal part of the sheath core 410 is provided with a fixing sleeve 411, and a guiding hole 412 for the first pull wire 440 to extend is penetrated between the inner wall of the sheath core 410 and the outer wall of the fixing sleeve 411. The extending direction of the guiding hole 412 is arranged obliquely with respect to the axis of the sheath core 410;

[0074] The guiding hole 412 is a hole inner edge 414 at the inner wall of the sheath core 410 and a hole outer edge 413 at the outer wall of the fixing sleeve 411. The hole outer edge 413 has a smooth flared structure.

[0075] The stress concentration part where the first pull wire 440 turns is mainly at the hole outer edge 413. In this embodiment, it is set as a smooth flared structure to protect the first pull wire 440, facilitate the release of the first pull wire 440, and when the position of the stent 310 is not good, it can also be pulled back and released again.

[0076] The extending direction of the guiding hole 412 determines the extending direction of the first pull wire 440. Combining Figure 14 with the orientation in the figure, the closer to the distal end, the more outwardly the guiding hole 412 is inclined.

[0077] In order to facilitate the release and recovery of the first pull wire 440 to control the stent 310, in one embodiment, the conveying device 400 further includes a first wire loop 441 that sequentially passes through each wire-passing hole 330 along the circumferential direction of the stent 310. The first pull wire 440 is connected to the first wire loop 441 and is pulled at at least two parts of the first wire loop 441.

[0078] The first wire loop 441 can drive all the sharp-corner parts of the pre-release end 350 to retract and extend synchronously, and at least two parts of the first wire 440 and the first wire loop 441 are pulled against each other to form a pulling method similar to that of a parachute, with a smoother movement and without damaging the pre-positioning effect of the anchoring arm 320.

[0079] The first wire 440 and the first wire loop 441 can be pulled against each other by knotting or by being movably wound around each other. Preferably, they are movably wound around each other to facilitate the release of the pulling between the two and the recovery of the first wire 440. The first wire loop 441 is made of a biocompatible material and can remain in the body with the stent or can be recovered after the artificial heart valve 300 has stabilized in operation.

[0080] In order to control the first wire at the handle, the first wire 440 is directly connected to the handle or is connected to the handle via a first pipe fitting 450 slidably installed in the sheath core 410.

[0081] In order to facilitate the recovery of the wire, one end of the first wire 440 can pass through the sheath core 410 and be wound around the first wire loop 441. The other end of the first wire 440 has two strands. One strand is connected to the fixing sleeve 411 (without extending into the sheath core 410), and the other strand extends proximally in the sheath core 410 to the handle or is connected to the handle via the first pipe fitting 450.

[0082] When recovering the first wire 440, after cutting one of the strands, pulling can release the winding around the first wire loop 441 until it is detached from the body.

[0083] During the operation, the release of the anchoring arm 320 can be completed by retracting the outer sheath tube 420. However, the retraction amplitude of the outer sheath tube generally still restricts the posterior release end 360. After the pre-release end 350 is released, the outer sheath tube 420 is further retracted to expose and release the posterior release end 360. In some embodiments, the cooperation mode between the posterior release end 360 of the artificial heart valve 300 and the mounting head 460 is disclosed.

[0084] In one embodiment, the posterior release end 360 of the artificial heart valve 300 and the mounting head 460 are mutually engaged through a shape-matching positioning structure. In the compressed state, the positioning structure restricts the axial position of the stent 310, and in the released state, the positioning structure is disengaged.

[0085] For example Figure 17 As can be seen, the positioning structure includes a T-shaped slot 461 on the outer periphery of the mounting head 460 and a T-shaped connecting ear 340 on the stent 310. The slot 461 and the connecting ear 340 cooperate with each other. Only when the outer sheath tube 420 is retracted to expose the connecting ear 340 will it disengage from the slot 461 to allow the posterior release end 360 to be released. And for example Figure 7The connecting lug 340 therein is annular, and correspondingly, a positioning post protrusion that mates with the annulus is provided on the outer periphery of the mounting head 460.

[0086] In one embodiment, the mounting head 460 is provided with a threading hole 462, and the delivery device 400 further includes a second wire 470 connected to the rear release end 360 of the artificial heart valve 300. The proximal end of the second wire 470 is coupled to the handle via the threading hole 462.

[0087] For example Figure 17 As can be seen in, the mounting head 460 is provided with a threading hole 462 generally along the axial direction. The rear release end 360 is similar to the front release end 350, and a wire-passing hole is provided at the pointed corner portion. The second wire 470 acts on each wire-passing hole to control the retraction and release of the rear release end 360.

[0088] For ease of control, a second pipe fitting 480 is slidably mounted in the radial gap between the sheath core 410 and the outer sheath 420 on the proximal side of the mounting head 460. The proximal end of the second wire 470 is connected to the distal end of the second pipe fitting 480 via the threading hole 462, and the proximal end of the second pipe fitting 480 is connected to the handle.

[0089] A wire loop may also be passed through the wire-passing hole of the rear release end 360. For example, the delivery device 400 further includes a second wire loop (omitted in the figure) that passes through the rear release end 360 of the stent 310 along the circumferential direction of the stent 310. The second wire 470 is connected to the second wire loop and is mutually pulled at at least two portions of the second wire loop. The cooperation mode between the second wire 470 and the second wire loop, as well as the setting mode of the second wire loop, are the same as those on the side of the front release end 350. Refer to Figure 19 , taking the front release end 350 as an example in the figure, the first wire loop 441 sequentially passes through each wire-passing hole 330. There are two first wires 440. One end of each is movably wound around the first wire loop 441, and the winding portions of the two first wires 440 and the first wire loop 441 are substantially symmetrical. There are six pointed corner portions in the figure, and the winding portions of the two first wires 440 and the first wire loop 441 are spaced apart by three pointed corners.

[0090] The other end of each first wire 440 is in two strands and is connected to the first pipe fitting 450, or one is connected to the first pipe fitting 450 and the other is connected to the fixed sleeve 411.

[0091] Combined with Figures 14 - 17 , when the artificial heart valve 300 is released, first, the position is confirmed to be appropriate through an imaging device, and then the outer sheath 420 is retracted proximally relative to the sheath core 410 until the anchoring arm 320 is completely exposed and released. At this time, the stent 310 itself is maintained in a compressed state, where the front release end is only controlled by the first wire 440, and the rear release end is still wrapped in the outer sheath 420.

[0092] After adjusting the posture to determine that the anchoring arm 320 matches the position of the surrounding tissue, release the first pull wire 440 to release the restraint on the first release end 350. Figure 16 It can be seen that the first release end 350 unfolds, and then the outer sheath tube 420 is further retracted until the second release end 360 is released. Finally, the first pull wire 440 is released by shearing or other means and withdrawn from the body together with the delivery device 400.

[0093] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope described in this specification. When the technical features in different embodiments are shown in the same drawing, the drawing can be regarded as also disclosing the combined examples of the various embodiments involved.

[0094] The above-described embodiments only represent several implementation manners of the present application. The description is relatively specific and detailed, but it should not be construed as a limitation on the scope of the patent application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several modifications and improvements can be made, and these all belong to the protection scope of the present application.

Claims

1. A delivery device having a distal end and a proximal end opposite thereto, the delivery device comprising a sheath core and an outer sheath tube slidably disposed around the sheath core, wherein a proximal end of both the sheath core and the outer sheath tube is connected to a handle for driving relative movement therebetween; characterized in that, The conveying device is loaded with an artificial heart valve, which includes a stent and a valve. The stent is cylindrical and has relative compressed and released states according to its radial deformation. The inside of the stent is a blood flow channel. The valve is connected inside the stent to open or close the blood flow channel. An anchoring arm for interacting with the native tissue of the lesion is connected to the stent. In the compressed state, the anchoring arm adheres to the outer peripheral wall of the stent. In the released state, the anchoring arm turns outward in the radial direction of the stent; The two ends of the stent in its own axial direction are relatively the first release end and the second release end. An installation head matching with the second release end is fixed on the sheath core; The first release end includes a plurality of wire passing holes distributed circumferentially. The first release end of the stent includes a plurality of pointed corner parts distributed circumferentially. Each pointed corner part is provided with the wire passing hole. The conveying device further includes a first wire loop sequentially passing through each wire passing hole along the circumference of the stent; The outer periphery of the distal part of the sheath core is provided with a fixing sleeve, and a guiding hole penetrates from the inner wall of the sheath core to the outer wall of the fixing sleeve; A first pulling wire is arranged inside the sheath core. One end of the first pulling wire passes out of the guiding hole and is pulled with at least two parts of the first wire loop to restrict the release of the first release end later than the release of the anchoring arm. The other end of the first pulling wire extends proximally inside the sheath core and is controlled by the handle; The first pulling wire is directly connected to the handle or is connected to the handle via a first pipe fitting slidably installed inside the sheath core.

2. The conveying device according to claim 1, characterized in that, The stent is woven with metal wires, and at least one section of at least one metal wire extends out of the outer periphery of the stent and forms the anchoring arm after being detoured; or The stent together with the anchoring arm is integrally cut from a metal pipe; or The stent is cut from a metal pipe, and the anchoring arm is welded and fixed to the stent.

3. The conveying device according to claim 1, wherein, The anchoring arm is a frame structure, including a root part connected to the stent and a head part far from the stent in the released state. The shape gradually converges from the root part to the head part, and the outer edge of the head part is an arc structure.

4. The conveying device according to claim 1, wherein The extending direction of the guiding hole is arranged obliquely relative to the axis of the sheath core; the guiding hole is an inner edge of the hole at the inner wall of the sheath core and an outer edge of the hole at the outer wall of the fixing sleeve. The outer edge of the hole has a smooth flared structure.

5. The conveying device according to claim 1, wherein The cooperation mode between the second release end of the artificial heart valve and the installation head is: The second release end of the artificial heart valve and the installation head are mutually clamped through a positioning structure with matching shapes. In the compressed state, the positioning structure restricts the axial position of the stent. In the released state, the positioning structure releases the cooperation; or The installation head is provided with a threading hole. The conveying device further includes a second pulling wire connected to the second release end of the artificial heart valve. The proximal end of the second pulling wire is coupled to the handle through the threading hole.

6. The conveying device according to claim 5, characterized in that, A second pipe fitting is slidably installed in the radial gap between the sheath core and the outer sheath tube on the proximal side of the installation head. The proximal end of the second pulling wire is connected to the distal end of the second pipe fitting through the threading hole, and the proximal end of the second pipe fitting is connected to the handle.

7. The conveying device according to claim 6, wherein The conveying device further includes a second wire loop that passes through the rear release end of the bracket along the circumferential direction of the bracket, and the second pulling wire is pulled by at least two parts of the second wire loop.

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