Prosthetic valve delivery device and system

Abstract

The application relates to a kind of artificial valve delivery device and system, artificial valve delivery device includes capsule part and catheter part, capsule part is capsule-shaped when delivering and recovering, artificial valve is loaded in capsule part after compression, and is radially constrained, capsule part is composed of distal capsule piece, loading piece and proximal capsule piece, three are connected with first control pipe, second control pipe, third control pipe in catheter part respectively, three control pipes are sequentially arranged from inside to outside, the separation of proximal capsule piece and distal capsule piece can be realized by the movement of first control pipe and third control pipe, thereby realizing the release of artificial valve, there are guide structure on both ends of loading piece of capsule part, coaxial section in the middle, the guide structure at both ends can guide proximal capsule piece and distal capsule piece gradually tend to coaxial when recovering, avoid capsule part scratch blood vessel or tissue when recovering, cause harm to patient.

Description

Technical Field

[0001] This invention relates to the field of medical devices for cardiac surgery, and more particularly to an artificial valve delivery device and system. Background Technology

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

[0003] In recent years, the successful advancement of aortic valve replacement has spurred exploration into transcatheter mitral valve replacement for regurgitation. However, mitral valve replacement is far more challenging than aortic valve replacement in many ways. For example, the mitral valve has a saddle-shaped spatial structure rather than the traditional round shape, and it possesses a more complex tissue structure (annulus, leaflets, chordae tendineae, papillary muscles, etc.). Treatment for valvular disease can involve implanting an artificial valve to replace the diseased native mitral valve.

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

[0005] In existing solutions, the delivery system via the femoral vein can have a capsule-shaped loading device at its distal end. The artificial valve can be loaded into the capsule after compression. The capsule is a split design and can be axially reconnected and retrieved after the valve is released. However, because the tubing inside the capsule is easy to bend, the ends of the two segmented capsules often cannot be aligned during capsule retrieval, causing axial misalignment. This makes it easy for the capsule to scrape the inner wall of the blood vessel and cause damage during withdrawal. Summary of the Invention

[0006] This invention discloses an artificial valve delivery device and system, which aims to solve the technical problems existing in the prior art.

[0007] The present invention adopts the following technical solution:

[0008] On one hand, the present invention provides an artificial valve delivery device, including a capsule portion and a catheter portion;

[0009] The capsule section includes a proximal capsule, a loading component, and a distal capsule arranged axially in sequence. The proximal capsule and the distal capsule are axially connected in the conveying state and are in the shape of a capsule. The loading component is disposed in the distal capsule.

[0010] 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 towards the axis of the loading component from the distal end to the proximal end, and the distal guide section extends towards the axis of the loading component from the proximal end to the distal end. The outer surface diameter of the coaxial section is the same. The coaxial section is coaxially arranged with the proximal capsule component and the distal capsule component. The coaxial section is provided with a fixing groove for connecting the artificial valve.

[0011] The catheter section includes a first control tube, a second control tube, and a third control tube, which are sequentially sleeved from the inside out. The three tubes can slide relative to each other axially. The distal end of the first control tube is fixed to the distal capsule component, the distal end of the second control tube is fixed to the loading component, and the distal end of the third control tube is fixed to the proximal capsule component.

[0012] As a preferred technical solution, at least a portion of the circumferential outer surface of the distal guide section is configured as a distal guide structure, which extends obliquely from the proximal end to the distal end toward the axis of the loading component, and the oblique angle of the distal guide structure is α, where α < 90°.

[0013] As a preferred technical solution, the remote guide structure is configured as a cone, frustum, hemispherical or semi-ellipsoidal shape.

[0014] As a preferred technical solution, the remote guide structure is configured as several inclined plate-like structures or rod-like structures, which are circumferentially distributed among the plate-like structures or rod-like structures.

[0015] As a preferred technical solution, at least a portion of the circumferential outer surface of the proximal guide section is configured as a proximal guide structure, which extends obliquely from the distal end to the proximal end toward the axis of the loading component, and the oblique angle of the proximal guide structure is β, where β < 90°.

[0016] As a preferred technical solution, the proximal guide structure is configured as a cone, frustum, hemispherical or semi-ellipsoidal shape.

[0017] As a preferred technical solution, the proximal guide structure is configured as several inclined plate-like structures or rod-like structures, which are circumferentially distributed among the plate-like structures or rod-like structures.

[0018] As a preferred technical solution, the axial lengths of the distal guide segment and the proximal guide segment may be the same or different.

[0019] As a preferred technical solution, the outer diameter of the coaxial section is adapted to the inner diameter of the distal capsule and / or proximal capsule, and the outer diameter of the coaxial section is slightly smaller than the inner diameter of the distal capsule and / or proximal capsule.

[0020] As a preferred technical solution, at least one fixed groove is provided with an elastic limiting member, which is capable of radial compression and rebound; the elastic limiting member is recessed in the fixed groove in the compressed state and protrudes out of the fixed groove in the rebound state; the outer diameter of the coaxial section in the rebound state of the elastic limiting member is slightly larger than the inner diameter of the distal capsule and the proximal capsule, and / or the outer diameter of the coaxial section in the rebound state of the elastic limiting member is not larger than the outer diameter of the distal capsule and the proximal capsule.

[0021] As a preferred technical solution, the proximal end of the distal capsule component and / or the distal end of the proximal capsule component are provided with a limiting groove, which can match the elastic limiting component in the rebound state.

[0022] As a preferred technical solution, the axial length of the proximal capsule component is less than the axial length of the distal capsule component, and the outer diameter of the proximal capsule component is the same as the outer diameter of the distal capsule component.

[0023] On the other hand, the present invention also provides an artificial valve delivery system, including an artificial valve delivery device and an artificial valve as described in any of the above claims; the distal end of the artificial valve is provided with a connector, which is releasably connected to a fixing groove on a loading member in the artificial valve delivery device.

[0024] The technical solution adopted in this invention can achieve the following beneficial effects:

[0025] This invention mainly provides an artificial valve delivery device and system. The artificial valve delivery device includes a capsule section and a catheter section. The capsule section is capsule-shaped during delivery and retrieval. The artificial valve is compressed and loaded into the capsule section and is radially constrained by it. The capsule section consists of a distal capsule element, a loading element, and a proximal capsule element. The three are respectively connected to a first control tube, a second control tube, and a third control tube in the catheter section. The three control tubes are arranged sequentially from the inside to the outside. By moving the first control tube and the third control tube, the proximal capsule element and the distal capsule element can be separated, thereby realizing the release of the artificial valve. Compared with a unilateral sliding capsule, the segmented capsule section of this invention has less room for movement in the patient's heart, which facilitates operation. Since the loading element does not move during the release of the artificial valve, the release of the artificial valve is simpler and the positioning is more accurate.

[0026] Furthermore, guide structures are provided at both ends of the capsule loading component, with a coaxial section in the middle. The guide structures at both ends can guide the proximal and distal capsule components to gradually move towards coaxiality during retrieval, preventing the capsule from scraping blood vessels or tissues during retraction and causing harm to the patient.

[0027] In addition, an elastic limiting element can be further set in the fixing groove of the loading component. The elastic limiting element can be compressed during transportation and rebound when the valve is released. After the elastic limiting element rebounds, it can assist the release of the artificial valve on the one hand, avoid the valve connector from getting stuck and causing release failure, and on the other hand, prevent the proximal capsule component from exceeding the coaxial section during movement, thereby preventing the distal capsule component from being guided by the distal guide structure. Attached Figure Description

[0028] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below, forming part of the present invention. The illustrative embodiments of the present invention and their descriptions explain the present invention and do not constitute an improper limitation of the present invention. In the drawings:

[0029] Figure 1 This is a schematic diagram of the structure of an artificial valve delivery device in a preferred embodiment of the present invention, as disclosed in Embodiment 1 of the present invention;

[0030] Figure 2 This is a schematic diagram of the distal structure of the artificial valve delivery device in a preferred embodiment of the present invention, as disclosed in Embodiment 1 of the present invention.

[0031] Figure 3 This is a schematic diagram of the capsule portion in a preferred embodiment of the present invention as disclosed in Embodiment 1;

[0032] Figure 4 This is a schematic diagram showing the dimensions of the distal capsule and the loading component in a preferred embodiment of the present invention, as disclosed in Embodiment 1.

[0033] Figure 5 This is a schematic diagram of the structure of the loading component in a preferred embodiment of the present invention, as disclosed in Embodiment 1.

[0034] Figure 6 for Figure 5 The left view;

[0035] Figure 7 This is a schematic diagram of the structure of the loading component in another preferred embodiment of the present invention disclosed in Embodiment 1;

[0036] Figure 8 for Figure 7 The left view;

[0037] Figure 9 This is a schematic diagram of a loading device connected to an artificial valve in a preferred embodiment of the present invention disclosed in Embodiment 1;

[0038] Figure 10 for Figure 9 DD cross-sectional view during artificial valve delivery;

[0039] Figure 11 for Figure 9 DD cross-sectional view after artificial valve deployment;

[0040] Figure 12 This is a schematic diagram of the capsule portion before the artificial valve is fully released in a preferred embodiment of the present invention as disclosed in Embodiment 1 of the present invention;

[0041] Figure 13 This is a schematic diagram of the capsule portion after the artificial valve has been fully released in a preferred embodiment of the present invention, as disclosed in Embodiment 1 of the present invention;

[0042] Figure 14 This is a schematic diagram of the capsule portion during recycling in a preferred embodiment of the present invention disclosed in Embodiment 1;

[0043] Figure 15a — Figure 15e This is an exploded view of the steps in the recycling process of the capsule portion in a preferred embodiment of the present invention disclosed in Embodiment 1;

[0044] Figure 16 This is a schematic diagram of the capsule portion inside the heart in a preferred embodiment of the present invention disclosed in Embodiment 1;

[0045] Figure 17a — Figure 17d This is a diagram showing the working state of the capsule portion during the release of the artificial valve in a preferred embodiment of the present invention, as disclosed in Embodiment 1 of the present invention.

[0046] Figure 18 This is a schematic diagram of the structure of an artificial valve encapsulated in a distal capsule in a preferred embodiment of Embodiment 2 of the present invention.

[0047] Explanation of reference numerals in the attached figures:

[0048] Capsule section 10, distal capsule component 11, loading component 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 component 124, proximal capsule component 13, limiting groove 14; catheter section 20, first control tube 21, second control tube 22, third control tube 23; artificial valve 30, connector 31, left atrium 40, left ventricle 50, mitral valve annulus 60. Detailed Implementation

[0049] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. In the description of this invention, it should be noted that the term "or" is generally used to include the meaning of "and / or," unless otherwise expressly indicated.

[0050] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. Furthermore, in the description of this application, the terms "first," "second," etc., are used only for distinguishing descriptions and should not be construed as indicating or implying relative importance. The term "proximal end" refers to the end along the length of the artificial valve delivery device that is closer to the operator, and the term "distal end" refers to the end along the length of the artificial valve delivery device that is farther from the operator. Terms such as "capsule-shaped," "conical," "frustum-shaped," "hemispherical," and "semi-ellipsoidal," etc., used herein are not absolute or standard shapes, but may be approximate related shapes. Those skilled in the art will understand that, in order to achieve their respective functions and meet the requirements of surgical operation, the specific shape / size / angle, etc., of each structure can be adaptively adjusted.

[0051] Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0052] To address the problems existing in the prior art, this application provides an artificial valve delivery device, including a capsule section 10 and a catheter section 20. The capsule section 10 includes a proximal capsule component 13, a loading component 12, and a distal capsule component 11 arranged axially in sequence. The proximal capsule component 13 and the distal capsule component 11 are axially connected in the delivery state, forming a capsule shape, and the loading component 12 is disposed between the two. The loading component 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 towards the axis of the loading component 12, and the distal guide section extends from the proximal end towards the distal end. Extending towards the axis of the loading component 12, the outer surface diameter of the coaxial section 122 is consistent. The coaxial section 122 is coaxially arranged with the proximal capsule component 13 and the distal capsule component 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 arranged sequentially from the inside to the outside. The three can slide relative to each other axially. The distal end of the first control tube 21 is fixed to the distal capsule component 11, the distal end of the second control tube 22 is fixed to the loading component 12, and the distal end of the third control tube 23 is fixed to the proximal capsule component 13.

[0053] Example 1

[0054] This embodiment provides an artificial valve delivery device, preferably suitable for the delivery and release of an artificial mitral valve. In this embodiment, the artificial valve 30 is in a compressed cylindrical shape during delivery. After being released at the original valve annulus, it expands radially. The expanded artificial valve 30 can support and fix itself at the original valve annulus, thus replacing the physiological function of the original valve. Preferably, the artificial valve 30 described in this embodiment is a self-expanding artificial valve 30, whose valve support is made of shape memory alloy. After losing radial constraint, it can automatically expand radially and anchor itself at the original valve annulus.

[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 structure of artificial valves 30 from different manufacturers varies after expansion, the specific structure of the artificial valve 30 is not specifically limited in this embodiment.

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

[0057] In a preferred embodiment, the capsule portion 10 is capsule-shaped during delivery. The capsule portion 10 includes a proximal capsule component 13, a distal capsule component 11, and a loading component 12 disposed between the two. The loading component 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 sequentially from the inside to the outside. The distal end of the first control tube 21 is fixedly connected to the distal capsule component 11, and a guide wire can pass through its interior. The distal end of the second control tube 22 is fixedly connected to the loading component 12, and the distal end of the third control tube 23 is fixedly connected to the proximal capsule component 13. The proximal end of the catheter portion 20 is disposed outside the body, and the axial movement of the first control tube 21 and the second control tube 22 can be realized through external operation.

[0058] like Figure 17a — Figure 17dIn a preferred embodiment, when the artificial valve 30 is released, the second control tube 22 and its connected loading member 12 remain in a fixed position, while the third control tube 23 moves proximally relative to the second control tube 22, causing the proximal capsule member 13 connected to it to retract proximally, exposing the inflow end of the artificial valve 30 first. Then, the first control tube 21 moves distally relative to the second control tube 22, causing the distal capsule member 11 connected to it to retract distally, releasing the main body of the artificial valve 30 and completing the valve replacement. When the capsule portion 10 is retrieved, the third control tube 23 is moved distally, causing the proximal capsule member 13 connected to it to advance distally, while the first control tube 21 is moved proximally, causing the distal capsule member 11 connected to it to retract proximally, ultimately achieving the reconnection of the proximal capsule member 13 and the distal capsule member 11, forming a capsule shape together with the loading member 12 before being withdrawn from the body.

[0059] In a preferred embodiment, the distal capsule 11 is fastened to the distal end of the first control tube 21 by means of bonding, heat fusion or threading. The distal end of the distal capsule 11 is provided with a guide head, and the guide head has an axially penetrating cavity that communicates with the first control tube 21 to allow the guide wire to pass through. The middle and proximal ends of the distal capsule 11 are generally cylindrical to accommodate the loading component 12 and the compressed artificial valve 30, and to radially constrain and support the artificial valve 30, so as to facilitate the axial transport of the entire delivery device in the human body, while avoiding the radial pressure of intravascular blood pressure on the delivery device.

[0060] like Figure 4 Preferably, the inner diameter of the middle and proximal ends of the distal capsule 11 is the same, both being A. The inner diameter A is slightly larger than the outer diameter of the loading member 12 and the outer diameter of the artificial valve 30 in the compressed state. The outer diameter of the loading member 12 and the outer diameter of the artificial valve 30 in the compressed state are the same, both being B, so as to ensure that the loading member 12 and the artificial valve 30 can move freely in the distal capsule 11.

[0061] like Figure 2 In a preferred embodiment, the outer diameter of the distal capsule 11 is no greater than 26F to avoid excessive damage caused by an excessively large outer diameter, and its length L2 is no greater than 40mm to avoid the artificial valve 30 being unable to be released due to excessive length, and to prevent the distal capsule 11 from pressing against the ventricular wall. More preferably, since the atrial height of a typical patient is significantly smaller than that of the ventricle, the axial length L2 of the distal capsule 11 is greater than the axial length L3 of the proximal capsule 13.

[0062] In a preferred embodiment, the proximal end of the proximal capsule 13 is fastened to the distal end of the third control tube 23 by means of bonding, heat fusion or threading, etc., and the two are axially connected to allow the second control tube 22 to pass through. The distal end and middle part of the proximal capsule 13 are cylindrical with the same inner diameter to accommodate the inflow section of the artificial valve 30. Its proximal end can be configured as a variable diameter structure and smoothly transitions 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 13 is the same as that of the distal capsule 11, both being A, to ensure that the artificial valve 30 can move freely without causing damage. The outer diameters of the proximal capsule 13 and the distal capsule 11 are also the same to ensure a smooth transition of the outer surfaces after they are connected, avoiding damage to the inner wall of the blood vessel during delivery or retraction.

[0064] In a preferred embodiment, the outer diameter of the proximal capsule 13 is consistent with that of the distal capsule 11, both not exceeding 26F, to avoid excessive damage caused by an excessively large outer diameter. Its length L3 is not greater than 20mm 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 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 11 is not greater than 40 mm, and the length L3 of the proximal capsule 13 is not greater than 20 mm, so as to ensure that both the proximal capsule 13 and the distal capsule 11 have sufficient space to move within the patient's heart, and to prevent the distal capsule 11 from hitting the ventricular wall when it moves forward, or the proximal capsule 13 from being blocked by the fossa ovalis when it retracts backward.

[0066] Preferably, the loading member 12 is fastened to the distal end of the second control tube 22 by means of bonding, heat fusion or threading. Since the artificial valve 30 in the compressed state still maintains its axially penetrating state, after the distal end of the artificial valve 30 is connected to the loading member 12, its main body is sleeved 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 member 13 and then exits, and the first control tube 21 exits from the distal end of the second control tube 22.

[0067] like Figure 5 , Figure 6In a preferred embodiment, the loading member 12 is provided with a proximal guide section, a coaxial section 122, and a distal guide section from the proximal end to the distal end. The proximal guide section extends from the distal end toward the axis of the loading member 12 to guide the proximal capsule 13 to move toward the distal end during retrieval. The distal guide section extends from the proximal end toward the axis of the loading member 12 to guide the distal capsule 11 to retract toward the proximal end during retrieval. The outer surface diameter of the coaxial section 122 is consistent, and the coaxial section 122 is coaxially arranged with the proximal capsule 13 and the distal capsule 11 to ensure that the proximal capsule 13 and the distal capsule 11 can remain coaxial during retrieval and 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 symmetrical structures or asymmetrical structures, and their lengths or dimensions 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, with an oblique angle of α, where 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, with an oblique angle of β, where 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 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, or even cause them to jam. Therefore, preferably, α is 30 to 80° and β is 30 to 80°.

[0071] In a preferred embodiment, the distal guide structure 121 is configured as a cone, frustum, hemisphere, or semi-ellipsoid to ensure that the distal capsule 11 can follow its contour to move proximally after abutting the distal guide structure 121, and finally abut against the proximal capsule 13.

[0072] like Figure 7 , Figure 8 In a preferred embodiment, the distal guide structure 121 is configured as several inclined plate-like structures or rod-like structures, such as distal guide rods 1211. The several plate-like structures or rod-like structures are circumferentially distributed among each other, which can also guide the running direction of the distal capsule 11 when it retracts to the proximal end.

[0073] like Figure 5 , Figure 6 In a preferred embodiment, the proximal guide structure 123 is configured as a cone, frustum, hemisphere or semi-ellipsoid to ensure that the proximal capsule 13 can follow its contour to move distally after abutting the proximal guide structure 123, and finally abut against the distal capsule 11.

[0074] like Figure 7 , Figure 8 In another preferred embodiment, the proximal guide structure 123 is configured as several inclined plate-like structures or rod-like structures, such as proximal guide rods 1231. The several plate-like structures or rod-like structures are circumferentially distributed among each other, which can also guide the movement direction of the proximal capsule 13 when it moves toward the distal end.

[0075] like Figure 5 , Figure 6 and Figure 9 Preferably, the coaxial section 122 is provided with several fixing grooves 1221 in the circumferential direction for connecting the connector 31 of the artificial valve 30 and restricting 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, so that when the artificial valve 30 loses the radial constraint of the distal capsule 11, it can be directly detached and released radially outward from the loading member 12.

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

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

[0078] like Figure 10 — Figure 14 Preferably, at least one fixing groove 1221 is provided with an elastic limiting member 124. The elastic limiting member 124 can be configured as an elastic polymer compound, or a limiting block provided with elasticity by a spring. The elastic limiting member 124 can be compressed and rebound radially within the fixing groove 1221. In the compressed state, the elastic limiting member 124 is recessed into the fixing groove 1221 by the pressure of the connector 31 of the artificial valve 30. Figure 10 and Figure 12 In the rebound state, the elastic limiting member 124 protrudes outward from the fixing groove 1221, such as... Figure 11 , Figure 13Furthermore, at this time, the outer diameter C of the coaxial segment 122 is slightly larger than the inner diameter A of the distal capsule 11 and / or the proximal capsule 13, which can prevent the proximal capsule 13 from exceeding the coaxial segment 122 during movement, thereby preventing the distal capsule 11 from being guided by the distal guide structure 121. In addition, after the elastic limiting member 124 rebounds, it can also assist in the release of the artificial valve 30, preventing the valve connector 31 from getting stuck and causing release failure. More preferably, in the rebound state, the elastic limiting member 124 protrudes outward from the fixing groove 1221, but at this time the outer diameter C of the coaxial segment 122 is not larger than the outer diameter of the distal capsule 11 and / or the proximal capsule 13, so as to ensure that the elastic limiting member 124 does not protrude outward from the outer surface of the capsule part 10 after the distal capsule 11 and the proximal capsule 13 are connected, preventing the capsule part 10 from scratching the inner wall of the blood vessel during the retraction process.

[0079] Preferably, a limiting groove 14 is provided at the distal end of the proximal capsule 13 and / or the proximal end of the distal capsule 11. The number of limiting grooves 14 is the same as the number of elastic limiting members 124, and they can match the elastic limiting blocks in the rebound state to ensure that the proximal capsule 13 and the distal capsule 11 can be completely aligned during retrieval. Figure 14 This is to avoid gaps between the two that could lead to unstable connections or scratches on the inner wall of the blood vessel.

[0080] like Figure 15a — Figure 15eIn a preferred embodiment, after the artificial valve 30 is released, the internal tubing of the delivery device is prone to bending. At this time, the proximal capsule 13, distal capsule 11, and loading device 12 are all out of axis. By advancing the third control tube 23, the proximal capsule 13 is advanced. During its advancement, the proximal capsule 13 contacts the proximal guide structure 123 of the loading device 12. Under the guidance of the proximal guide structure 123, the proximal capsule 13 gradually aligns with the loading device 12. 2. Coaxial and moved to coaxial segment 122. During the operation, the position of the proximal capsule 13 needs to be observed under imaging equipment. It cannot exceed the coaxial segment 122 of the loading member 12. Preferably, an elastic limiting member 124 is provided in the fixing groove 1221 of the coaxial segment 122. Since the elastic limiting member 124 loses its circumferential limiting after the artificial valve 30 is released, it can rebound and protrude out of the fixing groove 1221. After the proximal capsule 13 moves to the elastic limiting member 124, it is pressed against and... The proximal capsule 13 stops advancing, and its limiting groove 14 and elastic limiting member 124 can engage to achieve axial and circumferential limiting of the proximal capsule 13; then, the distal capsule 11 is retrieved by retracting the first control tube 21. During the retraction of the distal capsule 11, it contacts the distal guide structure 121 of the loading member 12. Under the guidance of the distal guide structure 121, the distal capsule 11 gradually becomes coaxial with the loading member 12 and moves to the coaxial section 122. During the operation, The position of the distal capsule 11 needs to be observed under imaging equipment. It cannot exceed the coaxial section 122 of the loading member 12. Preferably, the distal capsule 11 can also be stopped by the elastic limiting member 124 and no longer move backward. The limiting groove 14 of the distal capsule 11 and the elastic limiting member 124 can be engaged to achieve axial and circumferential limiting of the distal capsule 11. Finally, the coaxiality of the proximal capsule 13 and the distal capsule 11 is achieved 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 sequentially.

[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 a gap is reserved between adjacent tubes to ensure that the two adjacent tubes can move relative to each other axially.

[0083] Preferably, the inner lumen of the first control tube 21 should at least allow a medical guidewire to pass through. Since medical guidewires have different specifications and different diameters, in order to meet different patients or different lesions, the inner diameter of the first control tube 21 can be adaptively adjusted according to specific conditions, provided that the requirements of the operation are met. The possible diameters of its inner lumen are not listed here.

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

[0085] Preferably, the inner diameter and wall thickness of the second control tube 22 and the third control tube 23 can be referenced to the first control tube 21. Those skilled in the art can make adjustments according to actual needs, which will not be elaborated here.

[0086] In a preferred embodiment, when the artificial valve delivery device is used, it first passes through the femoral vein and through the fossa ovalis to reach the patient's mitral valve annulus 60. At this time, the junction of the proximal capsule 13 and the distal capsule 11 is at the mitral valve annulus 60. Figure 16 Through external manipulation, the third control tube 23 is retracted proximally, causing the proximal capsule 13 to retract as well. At this point, the atrial side of the artificial valve 30 expands. The operation continues, causing the first control tube 21 to advance distally, moving the distal capsule 11 forward. The ventricular side of the artificial valve 30 gradually expands. When the distal capsule 11 no longer encloses the loading component 12, the artificial valve 30 is released. After release, the third control tube 23 is advanced distally until the proximal capsule 13, guided by the proximal guide structure 123, encloses a portion of the loading component 12, achieving coaxial retrieval of the proximal capsule 13. Then, the first control tube 21 is retracted proximally until the distal capsule 11, guided by the distal guide structure 121, encloses a portion of the loading component 12, ultimately achieving coaxial closure with the proximal capsule 13.

[0087] Example 2

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

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

[0090] Preferably, the valve stent is generally cylindrical and mesh-like, with its inflow section located in the left atrium 40 and its outflow section opening into the left ventricle 50. The inflow end of the valve stent also has a radially outwardly expanding funnel-shaped or funnel-shaped skirt. 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 member 12. In a preferred embodiment, the valve stent is a self-expanding valve stent made of a nickel-titanium alloy with shape memory effect. When the artificial valve 30 is loaded onto the delivery device, it can be radially compressed and maintained in a compressed state by the radial constraint of the distal capsule member 11. Figure 18 When the artificial valve 30 reaches the diseased original valve, it is released from the proximal capsule 13 and the distal capsule 11, and can undergo radial self-expansion, eventually gradually detaching from the loading member 12.

[0091] Preferably, the leaflet is made of commercially available porcine aortic valve, bovine pericardial valve, or porcine pericardial valve, and is used to replace the physiological function of the original leaflet; the leaflet is sutured into the valve stent and extends from the proximal end to the distal end.

[0092] In other preferred embodiments, the surface of the valve stent may also be sewn with a skirt sealing membrane 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 that of the artificial valve delivery device in Embodiment 1, and will not be repeated here.

[0094] The embodiments of the present invention have been described above with reference to the accompanying drawings. However, the present invention is not limited to the specific embodiments described above. The specific embodiments described above are merely illustrative and not restrictive. Those skilled in the art can make many other forms under the guidance of the present invention without departing from the spirit and scope of the claims, and all of these forms are within the protection scope of the present invention.

Claims

1. An artificial valve delivery device, characterized in that, Includes the capsule portion and the duct portion; The capsule section includes a proximal capsule component, a loading component, and a distal capsule component arranged axially in sequence. The proximal capsule component and the distal capsule component are axially connected in the transport state and are in the shape of a capsule. The loading component is disposed in the distal capsule component. 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 towards the axis of the loading component from the distal end to the proximal end, and the distal guide section extends towards the axis of the loading component from the proximal end to the distal end. The outer surface diameter of the coaxial section is the same. The coaxial section is coaxially arranged with the proximal capsule and the distal capsule. The coaxial section is provided with a fixing groove for connecting the artificial valve. At least one of the fixed grooves is provided with an elastic limiting member, which is in a compressed state when the artificial valve is delivered and in a rebound state when the artificial valve is released; the elastic limiting member is recessed in the fixed groove in the compressed state and protrudes out of the fixed groove in the rebound state; the outer diameter of the coaxial section in the rebound state of the elastic limiting member is slightly larger than the inner diameter of the distal capsule and the proximal capsule, and the outer diameter of the coaxial section in the rebound state of the elastic limiting member is not larger than the outer diameter of the distal capsule and the proximal capsule; The proximal end of the distal capsule and / or the distal end of the proximal capsule are provided with a limiting groove, which can match the elastic limiting member in the rebound state to ensure the alignment of the proximal capsule and the distal capsule. The catheter portion includes a first control tube, a second control tube, and a third control tube sequentially sleeved from the inside out. The three tubes can slide relative to each other axially. The distal end of the first control tube is fixedly connected to the distal capsule, 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.

2. The artificial valve delivery device according to claim 1, characterized in that, At least a portion of the circumferential outer surface of the distal guide section is configured as a distal guide structure, the distal guide structure extending obliquely from the proximal end to the distal end toward the axis of the loading member, the oblique angle of the distal guide structure being α, where α < 90°.

3. The artificial valve delivery device according to claim 2, characterized in that, The distal guide structure is configured as a cone, frustum, hemispherical, or semi-ellipsoid.

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

5. The artificial valve delivery device according to claim 1, characterized in that, At least a portion of the circumferential outer surface of the proximal guide section is configured as a proximal guide structure, the proximal guide structure extending obliquely from the distal end to the proximal end toward the axis of the loading member, the oblique angle of the proximal guide structure being β, where β < 90°.

6. The artificial valve delivery device according to claim 5, characterized in that, The proximal guide structure is configured as a cone, frustum, hemispherical, or semi-ellipsoid.

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

8. The artificial valve delivery device according to claim 1, characterized in that, The distal guide segment may have the same or different axial lengths as the proximal guide segment.

9. The artificial valve delivery device according to claim 1, characterized in that, The outer diameter of the coaxial section is adapted to the inner diameter of the distal capsule and / or the proximal capsule.

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

11. The artificial valve delivery device according to any one of claims 1-10, characterized in that, The axial length of the proximal capsule is less than the axial length of the distal capsule, and the outer diameter of the proximal capsule is the same as the outer diameter of the distal capsule.

12. An artificial valve delivery system, characterized in that, Includes the artificial valve delivery device and artificial valve as described in any one of claims 1-11; The distal end of the artificial valve is provided with a connector, which can be releasably connected to a fixing groove on the loading component in the artificial valve delivery device.

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