Prosthetic valve delivery apparatus and system

Abstract

The present invention relates to a prosthetic valve delivery apparatus and system. The prosthetic valve delivery apparatus comprises a capsule part and a catheter part. The capsule part is in a capsule shape during delivery and recovery. A prosthetic valve is compressed, then loaded into the capsule part, and constrained by the capsule part in a radial direction. The capsule part consists of a distal capsule member, a loading member, and a proximal capsule member, which are connected to a first control tube, a second control tube, and a third control tube in the catheter part, respectively. The three control tubes are sequentially arranged from inside to outside. By means of the movement of the first control tube and the third control tube, the proximal capsule member can be separated from the distal capsule member, thereby achieving the release of the prosthetic valve. Guiding structures are arranged at both ends of the loading member of the capsule part, and the middle part is a coaxial section. The guiding structures at both ends can guide the proximal capsule member and the distal capsule member to gradually converge coaxially during recovery, thereby preventing the capsule part from scraping blood vessels or tissues when retracting and causing harm to patients.

Description

Artificial valve delivery device and system Technical Field

[0001] The present invention relates to the field of medical devices for cardiac surgery, and in particular to an artificial valve delivery device and system. Background Art

[0002] Mitral regurgitation is the most common heart valve disease. Although surgical treatment of mitral regurgitation is the primary criterion, these patients may refuse or be judged as unsuitable for traditional open surgery due to high risk.

[0003] In recent years, the successful advancement of aortic valve replacement has stimulated the exploration of transcatheter mitral valve replacement for the treatment of regurgitation. However, mitral valve replacement is significantly more difficult than aortic valve replacement in many respects. For example, the mitral valve's spatial structure is "saddle-shaped" rather than the traditional circular shape, and the mitral valve has a more complex anatomy (annulus, leaflets, chordae tendineae, and papillary muscles). Treatment for valvular disease can be achieved by implanting a prosthetic valve to replace the function of the diseased native mitral valve.

[0004] There are two common valve access methods for transcatheter mitral valve replacement: the transapical approach and the transfemoral vein-septal approach. The transfemoral vein approach is less invasive to the patient and more conducive to recovery.

[0005] In existing solutions, the distal end of the delivery system for femoral vein access can have a capsule-shaped loading component. The artificial valve can be loaded into the capsule component after compression. The capsule component is a split design and can be axially reconnected and recovered after the valve is released. However, since the tube inside the capsule component is easy to bend, the ends of the two segmented capsule components are often unable to be aligned when the capsule is recovered, resulting in axial misalignment between the two. This makes it easy for the capsule component to scrape the inner wall of the blood vessel during withdrawal from the body, causing damage.

[0006] Summary of the Invention

[0007] The present invention discloses an artificial valve delivery device and system, aiming to solve the technical problems existing in the prior art.

[0008] The present invention adopts the following technical solutions:

[0009] In one aspect, the present invention provides an artificial valve delivery device, comprising a capsule portion and a catheter portion;

[0010] The capsule part includes a proximal capsule part, a loading part and a distal capsule part which are axially arranged in sequence. The proximal capsule part and the distal capsule part are axially connected to each other in a conveying state and are in a capsule shape. The loading part is arranged in the distal capsule part.

[0011] The loading component is provided with a proximal guide section, a coaxial section, and a distal guide section in sequence from the proximal end to the distal end. The proximal guide section extends from the distal end to the proximal end toward the axis of the loading component, and the distal guide section extends from the proximal end to the distal end toward the axis of the loading component. The outer surface diameters of the coaxial sections are consistent. The coaxial sections are coaxially arranged with the proximal capsule component and the distal capsule component. The coaxial sections are provided with a fixing groove for connecting to the artificial valve.

[0012] The catheter portion includes a first control tube, a second control tube and a third control tube, which are sequentially arranged from the inside to the outside. The three control tubes can slide axially relative to each other. The distal end of the first control tube is fixedly connected to the distal capsule component, the distal end of the second control tube is fixedly connected to the loading component, and the distal end of the third control tube is fixedly connected to the proximal capsule component.

[0013] As a preferred technical solution, at least part of the circumferential outer surface of the distal guide segment is configured as a distal guide structure, which extends obliquely toward the axis of the loading part from the proximal end to the distal end, and the inclination angle of the distal guide structure is α, α<90°.

[0014] As a preferred technical solution, the distal guide structure is configured in a cone, a truncated cone, a semi-spherical shape or a semi-ellipsoidal shape.

[0015] As a preferred technical solution, the distal guide structure is configured as a plurality of obliquely arranged plate-like structures or rod-like structures, and the plurality of plate-like structures or rod-like structures are distributed circumferentially.

[0016] As a preferred technical solution, at least part of the circumferential outer surface of the proximal guide segment is configured as a proximal guide structure, which extends obliquely from the distal end to the proximal end toward the axis of the loading part, and the inclination angle of the proximal guide structure is β, β<90°.

[0017] As a preferred technical solution, the proximal guide structure is configured in a cone shape, a truncated cone shape, a semi-spherical shape or a semi-ellipsoidal shape.

[0018] As a preferred technical solution, the proximal guide structure is configured as a plurality of obliquely arranged plate-like structures or rod-like structures, and the plurality of plate-like structures or rod-like structures are distributed circumferentially.

[0019] As a preferred technical solution, the axial lengths of the distal guide segment and the proximal guide segment are the same or different.

[0020] As a preferred technical solution, the outer diameter of the coaxial section is adapted to the inner diameter of the distal capsule component and / or the proximal capsule component, and the outer diameter of the coaxial section is slightly smaller than the inner diameter of the distal capsule component and / or the proximal capsule component.

[0021] As a preferred technical solution, an elastic limiter is provided in at least one fixed groove, and the elastic limiter can be compressed and rebounded in the radial direction; the elastic limiter is concave in the fixed groove in the compressed state, and convex outside the fixed groove in the rebound state; the outer diameter of the coaxial section in the rebound state of the elastic limiter is slightly larger than the inner diameter of the distal capsule part and the proximal capsule part, and / or the outer diameter of the coaxial section in the rebound state of the elastic limiter is not larger than the outer diameter of the distal capsule part and the proximal capsule part.

[0022] As a preferred technical solution, a limiting groove is provided at the proximal end of the distal capsule component and / or the distal end of the proximal capsule component, and the limiting groove can match the elastic limiting component in the rebound state.

[0023] As a preferred technical solution, the axial length of the proximal capsule part is smaller than the axial length of the distal capsule part, and the outer diameter of the proximal capsule part is the same as the outer diameter of the distal capsule part.

[0024] On the other hand, the present invention also provides an artificial valve delivery system, comprising an artificial valve delivery device and an artificial valve as described above; a connecting piece is provided at the distal end of the artificial valve, and the connecting piece can be releasably connected to a fixing groove on a loading piece in the artificial valve delivery device.

[0025] The technical solution adopted by the present invention can achieve the following beneficial effects:

[0026] The present invention mainly provides an artificial valve delivery device and system, wherein the artificial valve delivery device includes a capsule part and a catheter part. The capsule part is in a capsule shape during delivery and recovery. The artificial valve is compressed and loaded in the capsule part and is subject to its radial constraints. The capsule part is composed of a distal capsule part, a loading part and a proximal capsule part. The three are respectively connected to the first control tube, the second control tube and the third control tube in the catheter part. The three control tubes are arranged in sequence from the inside to the outside. The proximal capsule part and the distal capsule part can be separated by moving the first control tube and the third control tube, thereby realizing the release of the artificial valve. Compared with a unilateral sliding capsule, the segmented capsule part in the present invention has a smaller moving space in the patient's heart, which is convenient for operation. Since the loading part does not move during the release of the artificial valve, the release of the artificial valve is simpler and the positioning is more accurate.

[0027] Furthermore, guide structures are provided at both ends of the loading part of the capsule part, and the middle part is a coaxial section. The guide structures at both ends can guide the proximal capsule part and the distal capsule part to gradually tend to be coaxial during recovery, thereby preventing the capsule part from scraping blood vessels or tissues during withdrawal and causing harm to the patient.

[0028] In addition, an elastic limiter can be further provided in the fixing groove of the loading part. The elastic limiter can be compressed during transportation and rebound when the valve is released. After the elastic limiter rebounds, on the one hand, it can assist in the release of the artificial valve to avoid the valve connector getting stuck and causing release failure. On the other hand, it can prevent the proximal capsule part from exceeding the coaxial section during movement, thereby causing the distal capsule part to be unable to be guided by the distal guide structure. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments, which constitute a part of the present invention. The exemplary embodiments of the present invention and their descriptions are provided to explain the present invention and do not constitute an undue limitation of the present invention. In the drawings:

[0030] FIG1 is a schematic structural diagram of an artificial valve delivery device according to a preferred embodiment of the present invention disclosed in Example 1;

[0031] FIG2 is a schematic diagram of the distal structure of an artificial valve delivery device in a preferred embodiment disclosed in Example 1 of the present invention;

[0032] FIG3 is a schematic diagram of a capsule portion in a preferred embodiment disclosed in Example 1 of the present invention;

[0033] FIG4 is a schematic diagram showing the dimensions of a distal capsule component and a loading component in a preferred embodiment disclosed in Example 1 of the present invention;

[0034] FIG5 is a schematic structural diagram of a loading member in a preferred embodiment disclosed in Example 1 of the present invention;

[0035] FIG6 is a left side view of FIG5;

[0036] FIG7 is a schematic structural diagram of a loading member in another preferred embodiment disclosed in Example 1 of the present invention;

[0037] FIG8 is a left side view of FIG7;

[0038] FIG9 is a schematic structural diagram of a carrier connected to an artificial valve in a preferred embodiment disclosed in Example 1 of the present invention;

[0039] FIG10 is a DD cross-sectional view of FIG9 during delivery of the artificial valve;

[0040] FIG11 is a DD cross-sectional view of FIG9 after the artificial valve is released;

[0041] FIG12 is a schematic diagram of a capsule portion before the artificial valve is completely released in a preferred embodiment disclosed in Example 1 of the present invention;

[0042] FIG13 is a schematic diagram of a capsule portion after the artificial valve is completely released in a preferred embodiment disclosed in Example 1 of the present invention;

[0043] FIG14 is a schematic diagram of a capsule portion during recycling in a preferred embodiment disclosed in Example 1 of the present invention;

[0044] Figures 15a to 15e are exploded views of steps in the recovery process of the capsule portion in a preferred embodiment disclosed in Example 1 of the present invention;

[0045] FIG16 is a schematic diagram of a capsule portion within the heart in a preferred embodiment disclosed in Example 1 of the present invention;

[0046] Figures 17a to 17d are working state diagrams of the capsule portion when releasing the artificial valve in a preferred embodiment disclosed in Example 1 of the present invention;

[0047] FIG18 is a schematic structural diagram of an artificial valve encapsulated in a distal capsule in a preferred embodiment disclosed in Example 2 of the present invention.

[0048] Explanation of the accompanying drawings: Capsule part 10, distal capsule part 11, loading part 12, distal guide structure 121, distal guide rod 1211, coaxial section 122, fixing groove 1221, proximal guide structure 123, proximal guide rod 1231, elastic limiting part 124, proximal capsule part 13, limiting groove 14; catheter part 20, first control tube 21, second control tube 22, third control tube 23; artificial valve 30, connecting part 31, left atrium 40, left ventricle 50, mitral valve ring 60. DETAILED DESCRIPTION

[0049] To make the objectives, technical solutions, and advantages of the present invention more clear, the technical solutions of the present invention will be clearly and completely described below in conjunction with specific embodiments of the present invention and corresponding drawings. In the description of the present invention, it should be noted that the term "or" is generally used in the sense of including "and / or" unless the content clearly indicates otherwise.

[0050] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected" and "connected" should be understood in a broad sense. In addition, in the description of this application, the terms "first", "second" and the like are only used to distinguish the description and cannot be understood as indicating or implying relative importance. The "proximal end" described in the text refers to the end close to the operator along the length direction of the artificial valve delivery device, and the "distal end" refers to the end away from the operator along the length direction of the artificial valve delivery device. The "capsular", "conical", "truncated cone", "hemispherical", "hemispherical" and so on described in this article are not absolute or standard shapes, but can also be roughly related shapes. Those skilled in the art will know that in order to achieve their respective functions and meet the requirements of surgical operations, the specific shapes / sizes / angles of each structure can be adaptively adjusted.

[0051] Obviously, the embodiments described are only some of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0052] In order to solve the problems existing in the prior art, the embodiment of the present application provides an artificial valve delivery device, including a capsule part 10 and a catheter part 20; the capsule part 10 includes a proximal capsule part 13, a loading part 12 and a distal capsule part 11 arranged in sequence axially, the proximal capsule part 13 and the distal capsule part 11 are axially connected to each other in the delivery state, and are in the shape of a capsule, and the loading part 12 is arranged between the two; the loading part 12 is provided with a proximal guide section, a coaxial section 122 and a distal guide section in sequence from the proximal end to the distal end, the proximal guide section extends from the distal end to the proximal end toward the axis of the loading part 12, and the distal guide section extends from the proximal end to the distal end. The coaxial section 122 extends toward the axis of the loading part 12, and the outer surface diameter of the coaxial section 122 is consistent. The coaxial section 122 is coaxially arranged with the proximal capsule part 13 and the distal capsule part 11. The coaxial section 122 is provided with a fixing groove 1221 for connecting the artificial valve 30; the catheter part 20 includes a first control tube 21, a second control tube 22 and a third control tube 23 which are sequentially arranged from the inside to the outside. The three can slide axially relative to each other in pairs. The distal end of the first control tube 21 is fixedly connected to the distal capsule part 11, the distal end of the second control tube 22 is fixedly connected to the loading part 12, and the distal end of the third control tube 23 is fixedly connected to the proximal capsule part 13.

[0053] Example 1

[0054] This embodiment provides a prosthetic valve delivery device, preferably suitable for delivery and release of a prosthetic mitral valve. In this embodiment, the prosthetic valve 30 is compressed cylindrical during delivery and radially expands after release from the native valve annulus. The expanded prosthetic valve 30 supports and secures the native valve annulus, thereby replacing the physiological function of the native valve. Preferably, the prosthetic valve 30 described in this embodiment is a self-expanding prosthetic valve 30, whose valve stent is made of a shape memory alloy and can automatically expand radially and anchor to the native valve annulus after losing radial restraint.

[0055] It should be noted that the artificial valve delivery device described in this embodiment does not include the artificial valve 30 itself, and since the structures of the artificial valves 30 from different manufacturers after expansion are somewhat different, the specific structure of the artificial valve 30 is no longer specifically limited in this embodiment.

[0056] As shown in Figures 1 to 3, the artificial valve delivery device includes a capsule portion 10 and a catheter portion 20. The capsule portion 10 is arranged at the distal end and is used to load and release the artificial valve 30. The multiple tubes in the catheter portion 20 are respectively connected to the various components in the capsule portion 10. Through the axial relative movement of the multiple tubes, the capsule portion 10 can be separated and reconnected during recovery.

[0057] In a preferred embodiment, the capsule portion 10 is in a capsule shape during transportation. The capsule portion 10 includes a proximal capsule part 13, a distal capsule part 11 and a loading part 12 arranged therebetween. The loading part 12 is used to connect the compressed artificial valve 30. The catheter portion 20 includes a first control tube 21, a second control tube 22 and a third control tube 23 arranged in sequence from the inside to the outside. The distal end of the first control tube 21 is fixedly connected to the distal capsule part 11, and a guide wire can be passed through the interior thereof. The distal end of the second control tube 22 is fixedly connected to the loading part 12, and the distal end of the third control tube 23 is fixedly connected to the proximal capsule part 13. The proximal end of the catheter portion 20 is arranged outside the body, and the axial movement of the first control tube 21 and the second control tube 22 is achieved through in vitro operation.

[0058] As shown in Figures 17a to 17d, in a preferred embodiment, when the artificial valve 30 is released, the second control tube 22 and the loading part 12 connected thereto remain fixed in position, and the third control tube 23 moves proximally relative to the second control tube 22, driving the proximal capsule part 13 connected thereto to withdraw proximally, so that the inflow end of the artificial valve 30 is first exposed, and then the first control tube 21 is moved distally relative to the second control tube 22, driving the distal capsule part 11 connected thereto to withdraw distally, and the main body of the artificial valve 30 is released, completing the valve replacement; when the capsule part 10 is recovered, the third control tube 23 is controlled to move distally, so that the proximal capsule part 13 connected thereto advances distally, and the first control tube 21 is controlled to move proximally, so that the distal capsule part 11 connected thereto withdraws proximally, finally achieving the reconnection of the proximal capsule part 13 and the distal capsule part 11, and forming a capsule shape together with the loading part 12 and withdrawn from the body.

[0059] In a preferred embodiment, the distal capsule part 11 is fastened to the distal end of the first control tube 21 by bonding, hot melting or threading. The distal end of the distal capsule part 11 is provided with a guide head, and an axially through cavity is provided in the guide head. The cavity is connected with the first control tube 21 for the guide wire to pass through. The middle and proximal ends of the distal capsule part 11 are roughly tubular, which are used to accommodate the loading part 12 and the artificial valve 30 in a compressed state, and radially constrain and support the artificial valve 30 to facilitate the axial transportation of the entire delivery device in the human body, while avoiding the radial pressure of the intravascular blood pressure on the delivery device.

[0060] As shown in Figure 4, preferably, the inner diameters of the middle and proximal ends of the distal capsule part 11 are the same, both are A, and the inner diameter A is slightly larger than the outer diameter of the loading part 12 and the outer diameter of the artificial valve 30 in the compressed state. The outer diameter of the loading part 12 and the outer diameter of the artificial valve 30 in the compressed state are the same, both are B, to ensure that the loading part 12 and the artificial valve 30 can move freely in the distal capsule part 11.

[0061] As shown in Figure 2 , in a preferred embodiment, the outer diameter of distal capsule 11 is no greater than 26F to avoid significant damage caused by an excessively large outer diameter. Its length L2 is no greater than 40 mm to avoid preventing the prosthetic valve 30 from being released and causing distal capsule 11 to abut against the ventricular wall. More preferably, because the height of the atria of a typical patient is significantly smaller than that of the ventricles, the axial length L2 of distal capsule 11 is greater than the axial length L3 of proximal capsule 13.

[0062] In a preferred embodiment, the proximal end of the proximal capsule member 13 is fastened to the distal end of the third control tube 23 by bonding, hot melting or threading, and the two are axially connected to allow the second control tube 22 to penetrate. The distal end and the middle part of the proximal capsule member 13 are cylindrical with the same inner diameter, which is used to accommodate the inflow section of the artificial valve 30. Its proximal end can be configured as a variable diameter structure and smoothly transition with the third control tube 23 to avoid damage to the inner wall of the blood vessel during delivery or withdrawal.

[0063] Preferably, the inner diameter of the proximal capsule part 13 is the same as the inner diameter of the distal capsule part 11, both of which are A, to ensure that the artificial valve 30 can move freely without causing damage to it. The outer diameters of the proximal capsule part 13 and the distal capsule part 11 are also the same to ensure a smooth transition of the outer surfaces after the two are connected, avoiding damage to the inner wall of the blood vessel during delivery or withdrawal.

[0064] In a preferred embodiment, the outer diameter of the proximal capsule part 13 is consistent with that of the distal capsule part 11, and both are no more than 26F to avoid greater damage caused by excessive outer diameter. Its length L3 is no more than 20 mm to avoid the artificial valve 30 being unable to be released due to excessive length, and its proximal end will abut against the oval fossa of the intra-aortic septum.

[0065] In a preferred embodiment, the total length L1 of the capsule portion 10 is less than 60 mm, the length L2 of the distal capsule component 11 is not greater than 40 mm, and the length L3 of the proximal capsule component 13 is not greater than 20 mm, so as to ensure that the proximal capsule component 13 and the distal capsule component 11 have sufficient space to move in the patient's heart, thereby preventing the distal capsule component 11 from pressing against the ventricular wall when moving forward, or preventing the proximal capsule component 13 from being blocked by the fossa ovalis when retreating backward.

[0066] Preferably, the loading component 12 is fastened to the distal end of the second control tube 22 by bonding, hot melting or threading. Since the artificial valve 30 in the compressed state still maintains its axial penetration state, after the distal end of the artificial valve 30 is connected to the loading component 12, its main body is sleeved and loaded on the outer periphery of the second control tube 22, and the two are coaxially arranged. Preferably, the distal end of the second control tube 22 passes through the third control tube 23 and the proximal capsule component 13 and then comes out, and the first control tube 21 passes out from the distal end of the second control tube 22.

[0067] As shown in Figures 5 and 6, in a preferred embodiment, the loading member 12 is provided with a proximal guide section, a coaxial section 122 and a distal guide section in sequence from the proximal end to the distal end. The proximal guide section extends from the distal end to the proximal end toward the axis of the loading member 12, and is used to guide the proximal capsule member 13 to advance toward the distal end when it is recovered. The distal guide section extends from the proximal end to the distal end toward the axis of the loading member 12, and is used to guide the distal capsule member 11 to withdraw toward the proximal end when it is recovered. The outer surface diameter of the coaxial section 122 is consistent, and the coaxial section 122 is coaxial with the proximal capsule member 13 and the distal capsule member 11 to ensure that the proximal capsule member 13 and the distal capsule member 11 can remain coaxial during recovery to avoid damage to blood vessels or tissues.

[0068] In a preferred embodiment, at least a portion of the circumferential outer surface of the distal guide segment is configured as a distal guide structure 121, and at least a portion of the circumferential outer surface of the proximal guide segment is configured as a proximal guide structure 123. The distal guide structure 121 and the proximal guide structure 123 can be configured as a symmetrical structure or an asymmetrical structure, and the lengths or sizes of the two can be the same or different.

[0069] In a preferred embodiment, the distal guide structure 121 extends obliquely from the proximal end to the distal end toward the axis of the loading member 12, and its inclination angle is α, α < 90°; the proximal guide structure 123 extends obliquely from the distal end to the proximal end toward the axis of the loading member 12, and its inclination angle is β, β < 90°; optionally, α and β can be the same or different.

[0070] Preferably, when the angles α and / or β are too small, the length of the distal guide structure 121 and / or the proximal guide structure 123 will be too long, which will affect the size and operation of the entire capsule part 10. When the angles α and / or β are too large, the guiding effect of the distal guide structure 121 and / or the proximal guide structure 123 will be poor, and even cause the two to get stuck. Therefore, preferably, α is 30~80° and β is 30~80°.

[0071] In a preferred embodiment, the distal guide structure 121 is configured as a cone, a truncated cone, a hemispherical or a semi-ellipsoidal shape to ensure that the distal capsule part 11 can move proximally following its contour after abutting against the distal guide structure 121 and finally abut against the proximal capsule part 13.

[0072] As shown in Figures 7 and 8, in a preferred embodiment, the distal guide structure 121 is configured as several inclined plate-like structures or rod-like structures, such as the distal guide rod 1211. The several plate-like structures or rod-like structures are circumferentially distributed between them, and can also guide the running direction of the distal capsule member 11 when it retracts toward the proximal end.

[0073] As shown in Figures 5 and 6, in a preferred embodiment, the proximal guide structure 123 is configured as a cone, a truncated cone, a hemispherical or a semi-ellipsoidal shape to ensure that the proximal capsule part 13 can move distally following its contour after abutting against the proximal guide structure 123 and finally abut against the distal capsule part 11.

[0074] As shown in Figures 7 and 8, in another preferred embodiment, the proximal guide structure 123 is configured as several inclined plate-like structures or rod-like structures, such as the proximal guide rod 1231. The several plate-like structures or rod-like structures are circumferentially distributed between them, and can also guide the movement direction of the proximal capsule member 13 when it moves toward the distal end.

[0075] As shown in Figures 5, 6 and 9, preferably, the coaxial section 122 is circumferentially provided with several fixing grooves 1221 for connecting the connector 31 of the artificial valve 30 and limiting the axial movement of the artificial valve 30. Preferably, the fixing groove 1221 is configured as an axially through groove that is radially open outward. When the artificial valve 30 loses the radial constraint of the distal capsule part 11, it can be directly detached and released radially outward from the loading part 12.

[0076] Specifically, the number and size of the fixing grooves 1221 on the loading part 12 match the connecting parts 31 on the artificial valve 30. Since artificial valves 30 of different specifications, different structures and different manufacturers have connecting parts 31 with different structures, the shape, number, size, etc. of the fixing grooves 1221 on the loading part 12 can be adaptively adjusted according to specific conditions and are not limited here.

[0077] In a preferred embodiment, the length L4 of the coaxial section 122 is 1-3 mm.

[0078] As shown in Figures 10 to 14, preferably, an elastic limiter 124 is provided in at least one fixing groove 1221. The elastic limiter 124 can be configured as a high molecular compound with elasticity, or a limiter block with elasticity provided by a spring. The elastic limiter 124 can be radially compressed and rebounded in the fixing groove 1221. In the compressed state, the elastic limiter 124 is concave in the fixing groove 1221 due to the pressure of the connecting member 31 of the artificial valve 30, as shown in Figures 10 and 12; in the rebound state, the elastic limiter 124 protrudes outside the fixing groove 1221, as shown in Figures 11 and 13, and at this time the outer diameter C of the coaxial section 122 is slightly larger than the inner diameter A of the distal capsule member 11 and / or the proximal capsule member 13, which can Prevent the proximal capsule part 13 from exceeding the coaxial section 122 during movement, thereby causing the distal capsule part 11 to be unable to be guided by the distal guide structure 121. In addition, after the elastic limiter 124 rebounds, it can also assist in the release of the artificial valve 30, and prevent the valve connector 31 from getting stuck and causing release failure; more preferably, in the rebound state, the elastic limiter 124 protrudes outside the fixing groove 1221, but at this time the outer diameter C of the coaxial section 122 is not greater than the outer diameter of the distal capsule part 11 and / or the proximal capsule part 13, so as to ensure that the elastic limiter 124 does not protrude from the outer surface of the capsule part 10 after the distal capsule part 11 and the proximal capsule part 13 are connected, thereby preventing the capsule part 10 from scratching the inner wall of the blood vessel during the withdrawal process.

[0079] Preferably, a limiting groove 14 is provided at the distal end of the proximal capsule part 13 and / or the proximal end of the distal capsule part 11. The number of the limiting grooves 14 is the same as the number of the elastic limiting parts 124, and can match the elastic limiting blocks in the rebound state, to ensure that the proximal capsule part 13 and the distal capsule part 11 can be completely aligned during recovery, as shown in Figure 14, to avoid the presence of a gap between the two, which may lead to an unstable connection or scratch the inner wall of the blood vessel.

[0080] As shown in Figures 15a to 15e, in a preferred embodiment, after the artificial valve 30 is released, the internal tubing of the delivery device is easily bent. At this time, the proximal capsule part 13, the distal capsule part 11 and the loading part 12 are not coaxial. By pushing the third control tube 23, the proximal capsule part 13 is advanced. During the advancement of the proximal capsule part 13, it contacts the proximal guide structure 123 of the loading part 12. Under the guidance of the proximal guide structure 123, the proximal capsule part 13 is guided by the proximal guide structure 123. 3 gradually becomes coaxial with the loading part 12 and moves to the coaxial section 122. During the operation, it is necessary to observe the position of the proximal capsule part 13 under the imaging device. It cannot exceed the coaxial section 122 of the loading part 12. Preferably, an elastic limiting member 124 is provided in the fixing groove 1221 of the coaxial section 122. Since the elastic limiting member 124 loses its circumferential limit after the artificial valve 30 is released, it can rebound and protrude out of the fixing groove 1221. The proximal capsule part 13 moves to the elastic limiting member 124. After that, it is stopped and no longer moves forward, and the limiting groove 14 of the proximal capsule part 13 and the elastic limiting part 124 can be engaged to realize the axial and circumferential limitation of the proximal capsule part 13; then the distal capsule part 11 is recovered by withdrawing the first control tube 21. When the distal capsule part 11 is withdrawn, it contacts the distal guide structure 121 of the loading part 12. Under the guidance of the distal guide structure 121, the distal capsule part 11 gradually becomes coaxial with the loading part 12 and moves to the coaxial section 122. During the process, it is necessary to observe the moving position of the distal capsule part 11 under the imaging equipment, and it cannot exceed the coaxial section 122 of the loading part 12. Preferably, the distal capsule part 11 can also be supported by the elastic limiting part 124 and no longer retreat, and the limiting groove 14 of the distal capsule part 11 and the elastic limiting part 124 can be snapped together to achieve axial and circumferential limitation of the distal capsule part 11, and finally achieve the coaxiality of the proximal capsule part 13 and the distal capsule part 11 to ensure that the artificial valve delivery device can be safely withdrawn from the body.

[0081] Preferably, the axial lengths of the first control tube 21 , the second control tube 22 , and the third control tube 23 decrease in sequence.

[0082] Preferably, the inner diameters of the first control tube 21 , the second control tube 22 and the third control tube 23 increase sequentially, and gaps are reserved between adjacent tubes to ensure that the two adjacent tubes can move axially relative to each other.

[0083] Preferably, the inner cavity of the first control tube 21 should at least allow a medical guide wire to pass through. Since medical guide wires have different specifications, and medical guide wires of different specifications have different diameters, in order to cope with different patients or different lesions, on the premise of meeting intraoperative requirements, the inner cavity diameter of the first control tube 21 can be adaptively adjusted according to specific conditions, and the optional inner cavity diameters are not listed one by one here.

[0084] Preferably, the first control tube 21 can be made of a sheath or a catheter. Those skilled in the art should understand that when selecting guide wires of different specifications, a catheter or sheath that is compatible with it should be selected. Therefore, the wall thickness of the first control tube 21 is no longer limited in this embodiment.

[0085] Preferably, the inner diameter and wall thickness of the second control tube 22 and the third control tube 23 may refer to the first control tube 21 , and those skilled in the art may adjust them according to actual needs, which will not be described in detail here.

[0086] In a preferred embodiment, when the artificial valve delivery device is in use, it first passes through the femoral vein through the fossa ovalis to reach the patient's mitral valve annulus 60. At this time, the boundary line between the proximal capsule part 13 and the distal capsule part 11 is at the mitral valve annulus 60, as shown in Figure 16. Through in vitro operation, the third control tube 23 is retracted proximally, driving the proximal capsule part 13 to retract. At this time, the atrial side of the artificial valve 30 expands. Continuing the operation, the first control tube 21 is advanced distally, driving the distal capsule part 11 to move forward. At this time, the ventricular side of the artificial valve 30 gradually expands. When the distal capsule part 11 no longer wraps the loading part 12, the artificial valve 30 is released. After the release is completed, the third control tube 23 is controlled to advance toward the distal end until the proximal capsule part 13 wraps around a part of the loading part 12 under the guidance of the proximal guide structure 123, thereby realizing the coaxial recovery of the proximal capsule part 13. Then, the first control tube 21 is controlled to retract toward the proximal end until the distal capsule part 11 wraps around a part of the loading part 12 under the guidance of the distal guide structure 121, and finally realizes the coaxial closure with the proximal capsule part 13.

[0087] Example 2

[0088] This embodiment provides an artificial valve delivery system, including the artificial valve delivery device as described in Example 1, and also including an artificial valve 30; various features already included in Example 1 are naturally inherited in this embodiment.

[0089] In this embodiment, the artificial valve 30 at least includes a valve stent and valve leaflets.

[0090] Preferably, the valve stent is roughly in the shape of a cylindrical mesh tube, with its inflow section arranged in the left atrium 40 and the outflow section opening in the left ventricle 50. The inflow end of the valve stent is also provided with a trumpet-shaped or funnel-shaped skirt that expands radially outward. Preferably, a connector 31 is provided at the distal end of the valve stent, and the connector 31 matches the fixing groove 1221 of the loading part 12; in a preferred embodiment, the valve stent is a self-expanding valve stent, and the valve stent is made of nickel-titanium alloy with a shape memory effect. When the artificial valve 30 is loaded onto the conveying device, it can be radially compressed and maintained in its compressed state by the radial constraint of the distal capsule part 11, as shown in Figure 18; when the artificial valve 30 reaches the diseased native valve, it is released from the proximal capsule part 13 and the distal capsule part 11, and can undergo radial self-expansion, and eventually gradually detach from the loading part 12.

[0091] Preferably, the valve leaflets are made of commercial porcine aortic valves, bovine pericardial valves or porcine pericardial valves to replace the physiological functions of native valve leaflets; the valve leaflets are sutured into the valve stent and extend from the proximal end to the distal end.

[0092] In other preferred embodiments, a skirt sealing membrane may be sewn on the surface of the valve stent to prevent complications such as paravalvular leakage after valve replacement surgery.

[0093] In this embodiment, the method of using the artificial valve delivery system is the same as the method of using the artificial valve delivery device in Example 1, and will not be repeated here.

[0094] The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation methods. The above-mentioned specific implementation methods are merely illustrative and not restrictive. Under the guidance of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the present invention and the claims, all of which are protected by the present invention.

Claims

1. An artificial valve delivery device, characterized in that: It includes a capsule part and a catheter part; The capsule part comprises a proximal capsule part, a loading part and a distal capsule part which are sequentially arranged axially, the proximal capsule part and the distal capsule part are axially connected with each other in a conveying state and are in a capsule shape, and the loading part is arranged in the distal capsule part; The loading part is provided with a proximal guide section, a coaxial section and a distal guide section in sequence from the proximal end to the distal end, the proximal guide section extends from the distal end to the proximal end close to the axis of the loading part, the distal guide section extends from the proximal end to the distal end close to the axis of the loading part, the outer surface diameters of the coaxial sections are consistent, the coaxial sections are coaxially arranged with the proximal capsule part and the distal capsule part, and the coaxial sections are provided with a fixing groove for connecting an artificial valve; The catheter portion includes a first control tube, a second control tube and a third control tube which are sequentially sleeved from the inside to the outside, and the three can slide axially relative to each other in pairs. The distal end of the first control tube is fixedly connected to the distal capsule component, the distal end of the second control tube is fixedly connected to the loading component, and the distal end of the third control tube is fixedly connected to the proximal capsule component.

2. The artificial valve delivery device according to claim 1, characterized in that: At least a portion of the circumferential outer side surface of the distal guide segment is configured as a distal guide structure, which extends obliquely toward the axis of the loading part from the proximal end to the distal end, and the inclination angle of the distal guide structure is α, α<90°.

3. The artificial valve delivery device according to claim 2, characterized in that: The distal guiding structure is configured in a cone, a truncated cone, a semi-spherical shape or a semi-ellipsoidal shape.

4. The artificial valve delivery device according to claim 2, characterized in that: The distal guide structure is configured as a plurality of inclined plate-like structures or rod-like structures, and the plurality of plate-like structures or rod-like structures are distributed circumferentially.

5. The artificial valve delivery device according to claim 1, characterized in that: At least a portion of the circumferential outer side surface of the proximal guide segment is configured as a proximal guide structure, which extends obliquely from the distal end to the proximal end toward the axis of the loading member, and the inclination angle of the proximal guide structure is β, β<90°.

6. The artificial valve delivery device according to claim 5, characterized in that: The proximal guide structure is configured in a cone, a truncated cone, a semi-spherical shape or a semi-ellipsoidal shape.

7. The artificial valve delivery device according to claim 5, characterized in that: The proximal guide structure is configured as a plurality of inclined plate-like structures or rod-like structures, and the plurality of plate-like structures or rod-like structures are distributed circumferentially.

8. The artificial valve delivery device according to claim 1, characterized in that: The axial lengths of the distal guide segment and the proximal guide segment are the same or different.

9. The artificial valve delivery device according to claim 1, characterized in that: The outer diameter of the coaxial section is matched with the inner diameter of the distal capsule part and / or the proximal capsule part, and the outer diameter of the coaxial section is slightly smaller than the inner diameter of the distal capsule part and / or the proximal capsule part.

10. The artificial valve delivery device according to claim 9, characterized in that: An elastic stopper is provided in at least one of the fixing grooves, and the elastic stopper can be compressed and rebounded in the radial direction; The elastic limiting member is concave in the fixing groove in a compressed state, and is convex outside the fixing groove in a rebound state; The outer diameter of the coaxial section when the elastic limiting member is in the rebound state is slightly larger than the inner diameters of the distal capsule member and the proximal capsule member, and / or the outer diameter of the coaxial section when the elastic limiting member is in the rebound state is not larger than the outer diameters of the distal capsule member and the proximal capsule member.

11. The artificial valve delivery device according to claim 10, characterized in that: The proximal end of the distal capsule component and / or the distal end of the proximal capsule component are provided with a limiting groove, and the limiting groove can match the elastic limiting component in the rebound state.

12. The artificial valve delivery device according to any one of claims 1 to 11, characterized in that: The axial length of the proximal capsule part is smaller than the axial length of the distal capsule part, and the outer diameter of the proximal capsule part is the same as the outer diameter of the distal capsule part.

13. An artificial valve delivery system, characterized in that: Comprising an artificial valve delivery device and an artificial valve as described in any one of claims 1 to 12; A connecting piece is provided at the distal end of the artificial valve, and the connecting piece is releasably connected to a fixing groove on a loading piece in the artificial valve delivery device.

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