Delivery device system for artificial mitral valve implant

Abstract

A delivery device system for an artificial mitral valve implant. A distal movable sliding block (210) is driven by means of a front rotary knob (221) to axially move to enable a main stent (101) to be exposed or stored at a target position; and a proximal movable sliding block (212) is driven by means of a rear rotary knob (222) to axially move to enable an inner-layer stent (102) to be exposed or stored at the target position. By means of controlling the front rotary knob (221) and the rear rotary knob (222) to rotate separately or synchronously, the main stent (101) and the inner-layer stent (102) are released separately or synchronously, the interval time is short, and the displacement influence brought about by stress relief is reduced.

Description

Delivery device system for prosthetic mitral valve implant

[0001] This application claims priority to the Chinese patent application filed with the China Patent Office on August 28, 2023, with application number 202311083575.X. The entire contents of this application are incorporated by reference into this application. Technical Field

[0002] The present application belongs to the technical field of medical devices and relates to a delivery device system for an implant, for example, to a delivery device system for an artificial mitral valve implant. Background Art

[0003] Transcatheter mitral valve implantation (TMVI) is an interventional procedure that replaces a diseased or abnormal heart valve with an artificial valve. Mitral stenosis or mitral regurgitation are the indications. The mitral valve annulus is a saddle-shaped structure in space and a "D"-shaped structure when viewed in plan.

[0004] Since the mitral valve itself is relatively large, the size of the artificial mitral valve implant that matches it will also be correspondingly larger. Currently, the interventional mitral valve implants on the market are mostly single cylindrical in shape. After entering the body and being released and fixed in the position of the autologous mitral valve ring, they have a large radial support force, which will cause squeezing of the aortic root. The larger the size of the implant, the greater the radial support force will be, which will affect the function of the aortic valve.

[0005] For example, CN207804429U discloses a mitral valve prosthesis, a tricuspid valve prosthesis and a stent thereof, wherein the stent has a contracted state for delivery and an expanded state for deployment, and the stent includes an inflow channel, a transition region and an outflow channel along the axial direction, and the two ends of the transition region are respectively connected to the inflow channel and the outflow channel; in the expanded state, the inflow channel is located upstream of the blood flow direction of the outflow channel, and the radial stiffness of the inflow channel is less than the radial stiffness of the outflow channel and / or the transition region.

[0006] In addition, due to its large size, the height of the single cylindrical valve frame is relatively high, and the larger part of the mitral valve entering the left ventricle will also block the left ventricular outflow tract, thereby causing corresponding symptoms.

[0007] For example, CN218075337U discloses a mitral valve stent mechanism, including an outer stent and an inner stent connected to the outer stent; the outer stent includes: an outer frame body, a hollow cylindrical structure, the proximal end of the outer frame body is turned inward to form an upper skirt; a plurality of outer frame connecting rings are evenly arranged along the proximal inner side of the upper skirt; the inner stent includes: an inner frame body, a hollow cylindrical structure, located on the inner side of the outer frame body; a plurality of stent connecting buckles are evenly arranged along the distal circumference of the inner frame body; at least the proximal inner diameter of the outer stent is larger than the distal outer diameter of the inner stent, the inner frame connecting buckles and the outer frame connecting rings are connected by a back-end, and the inner stent is suspended on the inner side of the outer stent.

[0008] CN216777297U discloses a mitral valve stent, comprising a stent mechanism having an outer stent and an inner stent connected to the outer stent; the inner stent comprises, from the proximal end to the distal end: a traction portion, the proximal end of which is in a contracted shape; a first connection portion, which is a hollow columnar structure, the proximal end of which is connected to the traction portion; the outer stent comprises, from the proximal end to the distal end: a second connection portion, which is connected to the distal end of the traction portion, the proximal end of which is contracted inwardly, and the proximal end of the second connection portion is led out by the proximal end of the traction portion; a support portion, which is a hollow columnar structure, with the first connection portion arranged in an suspended manner inside.

[0009] In view of the shortcomings of related technologies, there is a need to provide a valve stent with a smaller valve frame height, which will not affect the aortic root and can be accurately released as an artificial mitral valve implant and its delivery device system.

[0010] Summary of the Invention

[0011] The purpose of the present application is to provide a delivery device system for an artificial mitral valve implant, which can accurately position the artificial mitral valve to the corresponding mitral valve ring position, and can realize the step-by-step or synchronous release of the main stent and the inner stent with a short interval time, thereby reducing the displacement effect caused by the release stress and performing release and fixation.

[0012] To achieve the purpose of this application, this application adopts the following technical solutions:

[0013] The present application provides a delivery device system for an artificial mitral valve implant, the delivery device system comprising a central component and a shell component;

[0014] The central assembly includes an outer sleeve, a distal moving slider, a main stent fixing tube, a fixing block, a step tube, a proximal moving slider, an inner stent fixing piece and a moving screw;

[0015] The proximal end of the main stent fixing tube is fixedly connected to the fixing block;

[0016] The proximal end of the inner layer support fixing piece is fixedly connected to the moving screw;

[0017] The step tube is passed through the fixing block, with a distal end having a cavity for accommodating the inner stent in a stored state, and a proximal end fixedly connected to the proximal movable slider; part of the step tube is accommodated in the cavity of the main stent fixing tube;

[0018] The main stent fixing tube is accommodated in the cavity of the outer sleeve, and the distal end has a cavity for accommodating the main stent in the storage state, and the proximal end is fixedly connected to the distal movable slider;

[0019] The housing assembly includes a front rotating knob, a rear rotating knob, a threaded knob, and a housing for accommodating the center assembly;

[0020] The front rotating knob drives the distal moving slider to move axially by rotating;

[0021] The rear rotation knob drives the proximal moving slider to move axially by rotating;

[0022] The threaded knob drives the movable screw to move axially by rotating;

[0023] The pitch of the internal thread structure of the front rotating knob is greater than or equal to the pitch of the internal thread structure of the rear rotating knob.

[0024] The delivery device system provided by the present application drives the distal movable slider to move axially by rotating the front knob, thereby exposing or storing the main stent fixing tube at the target position; drives the proximal movable slider to move axially by rotating the rear knob, thereby exposing or storing the inner stent at the target position; drives the distal movable slider to move axially by rotating the front knob, thereby releasing the main stent; drives the proximal movable slider to move axially by rotating the rear knob, thereby releasing the inner stent. The threaded knob drives the movable screw to move axially, thereby releasing the inner stent, and the release of the inner stent drives the release of the main stent, thereby utilizing distributed release to reduce the displacement effect caused by release stress.

[0025] In some embodiments, the pitch of the internal thread structure of the front rotating knob is greater than the pitch of the internal thread structure of the rear rotating knob. The present application achieves the sequential release of the main bracket and the inner layer bracket by making the pitch of the internal thread structure of the front rotating knob greater than the pitch of the internal thread structure of the rear rotating knob.

[0026] In some embodiments, the housing assembly further comprises a latch assembly;

[0027] The latch assembly includes a latch body;

[0028] The front rotating knob and the rear rotating knob are independently provided with a buckle cavity;

[0029] The latch body is slidably arranged in the buckle cavity.

[0030] When the front rotation knob and the rear rotation knob need to be rotated simultaneously, the latch body is inserted into the buckle cavity of the front rotation knob and the buckle cavity of the rear rotation knob at the same time.

[0031] In some embodiments, the distal end of the main bracket fixing tube is provided with a first hanging ear groove that cooperates with the first hanging ear structure; the first hanging ear structure cooperates with the first hanging ear groove to achieve fixation of the main bracket in the storage state.

[0032] In some embodiments, the number of the inner support bracket fixing members is the same as the number of the inner support brackets, and the distal end of the inner support bracket fixing member is provided with a second hanging ear groove that cooperates with the second hanging ear structure; the second hanging ear structure cooperates with the second hanging ear groove to achieve fixation of the inner support bracket in the storage state;

[0033] The number of the step tubes is the same as the number of the inner layer support fixing pieces, and each step tube accommodates one inner layer support fixing piece.

[0034] In some embodiments, the front rotation knob has an internal thread structure, and the internal thread structure of the front rotation knob cooperates with the external thread structure of the distal movable slider; the front rotation knob drives the distal movable slider to move axially by rotating;

[0035] The rear rotation knob has an internal thread structure, and the internal thread structure of the rear rotation knob cooperates with the external thread structure of the proximal movable slider; the rear rotation knob drives the proximal movable slider to move axially by rotating;

[0036] The threaded knob has an internal thread structure, and the internal thread structure of the threaded knob cooperates with the external thread structure of the movable screw; the threaded knob drives the movable screw to move axially by rotating.

[0037] In some embodiments, the artificial mitral valve implant corresponding to the delivery device system provided in the present application includes a main stent, at least two inner stents disposed inside the main stent, and a biological valve connected to the inner stent;

[0038] Along the axial direction of the main stent, the main stent includes a main stent flange structure at the distal end, a first hanging ear structure at the proximal end, and a main stent body section connecting the flange structure and the first hanging ear structure;

[0039] Along the axial direction of the inner layer stent, the inner layer stent includes a second hanging ear structure at the proximal end, and an inner layer stent main body section connected to the second hanging ear structure;

[0040] Each inner stent is provided with a biological valve;

[0041] The gap between the main support and the inner support is provided with sewing cloth.

[0042] In the artificial mitral valve implant provided in the present application, the function of the main stent flange structure is to hang on the heart valve ring during the release process to prevent the stent from detaching from the heart valve ring during and after release; the present application does not limit the specific structure of the main stent flange structure, as long as it can achieve the relevant functions.

[0043] The artificial mitral valve implant provided herein replaces the native valve by using at least two inner stents and a corresponding bioprosthetic valve, reducing the overall valve height and avoiding obstruction of the left ventricular outflow tract. Furthermore, the artificial mitral valve implant provided herein conforms to the mitral valve annulus while avoiding excessive compression of the aortic root, thereby preventing impact on the normal function of the aortic valve.

[0044] In the technical solution provided in this application, the "distal end" refers to the end away from the operator, that is, the end close to the patient's heart; the "proximal end" refers to the end close to the operator, that is, the end away from the patient's heart.

[0045] The artificial mitral valve implant provided in the present application has at least two inner layer stents arranged on the inner side of the main stent, for example, it can be 2, 3, 4 or 5, but is not limited to the listed values, and other values ​​not listed within the numerical range are also applicable.

[0046] Illustratively, the biological valve of the present application includes a sewing cloth and at least three leaflets connected to the sewing cloth; the sewing cloth is arranged on the inner side of the inner layer stent main body segment, connected to form a closed or non-closed ring, and the sewing cloth and the inner layer stent main body segment are connected and fixed by sutures; the at least three leaflets are connected to the sewing cloth by sutures, and the edges of the unsutured parts are sequentially abutted and closed to form a valve structure.

[0047] In the present application, the biological valve includes a sewing cloth and at least three leaflets connected to the sewing cloth. The number of leaflets is at least three, for example, it can be 3, 4, 5, 6 or 8, but is not limited to the listed values. Other unlisted values ​​within the numerical range are also applicable; the number of leaflets in the biological valve of the present application can be as long as it can achieve the function of the biological valve. Taking into account the structural complexity and cost, as the preferred technical solution, the number of leaflets in the biological valve is 3.

[0048] In some embodiments, in the expanded state, the height of the main stent body segment is 6-30 mm.

[0049] In some embodiments, in the expanded state, the height of the inner stent body segment is 6-40 mm.

[0050] In some embodiments, in the stowed state, the cross-sectional area of ​​the at least two inner stents is 40%-90% of the cross-sectional area of ​​the main stent.

[0051] In some embodiments, a barb structure is provided on the outer side of the main stent body section.

[0052] The artificial mitral valve implant provided in the present application is advantageous in improving the stability of the artificial mitral valve implant at the mitral valve ring in the expanded state by providing a barb structure on the outside of the main stent body segment, thereby avoiding the adverse effects caused by displacement. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] FIG1 is a schematic diagram of components of an artificial mitral valve implant without a biological valve provided in Examples 1-3 of the present application in a stowed state;

[0054] FIG2 is a schematic diagram of components of an artificial mitral valve implant including a biological valve provided in Examples 1-3 of the present application in a stowed state;

[0055] FIG3 is a schematic diagram of components of an artificial mitral valve implant provided in Examples 1-3 of the present application in an expanded state;

[0056] FIG4 is a schematic diagram of the assembly of the artificial mitral valve implant provided in Examples 1-3 of the present application;

[0057] FIG5 is a schematic structural diagram of the conveying device system provided in Example 4-5 of the present application;

[0058] FIG6 is an assembly diagram of a delivery device system provided in Examples 4-5 of the present application, showing an artificial mitral valve implant without a biological valve in a stored state;

[0059] FIG7 is an assembly diagram of a delivery device system provided in Examples 4-5 of the present application, in which a prosthetic mitral valve implant including a biological valve is housed;

[0060] FIG8 is an exploded schematic diagram of a delivery device system provided in Examples 4-5 of the present application showing a stowed state of an artificial mitral valve implant without a biological valve;

[0061] FIG9 is an exploded schematic diagram of a delivery device system provided in Examples 4-5 of the present application showing a stowed state of an artificial mitral valve implant including a biological valve;

[0062] FIG10 is a schematic structural diagram of a central component of the conveying device system provided in Examples 4-5 of the present application;

[0063] FIG11 is a schematic structural diagram of a housing assembly of a delivery device system provided in Examples 4-5 of the present application;

[0064] FIG12 is a schematic diagram showing the coordination of the central component and the outer shell component of the delivery device system provided in Examples 4-5 of the present application;

[0065] Figure 13 is a schematic diagram of the function of the latch assembly of the conveying device system provided in Examples 4-5 of the present application.

[0066] Wherein: 100, artificial mitral valve implant; 101, main stent; 1011, first ear hanging structure; 1012, main stent flange structure; 1013, main stent body; 1014, barb structure; 102, inner stent; 1021, second ear hanging structure; 1022, inner stent body; 103, biological valve; 1031, suture; 1032, valve leaflet;

[0067] 201, main bracket fixing tube; 2011, first ear groove; 202, inner bracket fixing piece; 2021, second ear groove; 203, step tube; 204, outer sleeve; 210, distal moving slider; 211, fixing block; 212, proximal moving slider; 213, moving screw; 220, shell; 221, front rotating knob; 2211, first snap-fit ​​cavity; 222, rear rotating knob; 2221, second snap-fit ​​cavity; 223, threaded knob; 224, latch assembly; 2241, latch body. DETAILED DESCRIPTION

[0068] The technical solution of the present application is further described below through specific implementation methods. Those skilled in the art should understand that the embodiments are only used to help understand the present application and should not be regarded as specific limitations of the present application.

[0069] A certain embodiment of the present application provides a delivery device system for an artificial mitral valve implant, the delivery device system comprising a central component and a shell component;

[0070] The central assembly includes an outer sleeve, a distal moving slider, a main stent fixing tube, a fixing block, a step tube, a proximal moving slider, an inner stent fixing piece and a moving screw;

[0071] The proximal end of the main stent fixing tube is fixedly connected to the fixing block;

[0072] The proximal end of the inner layer support fixing piece is fixedly connected to the moving screw;

[0073] The step tube is passed through the fixing block, with a distal end having a cavity for accommodating the inner stent in a stored state, and a proximal end fixedly connected to the proximal movable slider; part of the step tube is accommodated in the cavity of the main stent fixing tube;

[0074] The main stent fixing tube is accommodated in the cavity of the outer sleeve, and the distal end has a cavity for accommodating the main stent in the storage state, and the proximal end is fixedly connected to the distal movable slider;

[0075] The housing assembly includes a front rotating knob, a rear rotating knob, a threaded knob, and a housing for accommodating the center assembly;

[0076] The front rotating knob drives the distal moving slider to move axially by rotating;

[0077] The rear rotation knob drives the proximal moving slider to move axially by rotating;

[0078] The threaded knob drives the movable screw to move axially by rotating;

[0079] The pitch of the internal thread structure of the front rotating knob is greater than or equal to the pitch of the internal thread structure of the rear rotating knob.

[0080] The conveying device system provided in the present application drives the distal movable slider to move axially by the front rotating knob, thereby realizing exposure or storage of the main stent fixing tube at the target position; drives the proximal movable slider to move axially by the rear rotating knob, thereby realizing exposure or storage of the inner layer stent at the target position; the present application realizes step-by-step or synchronous release of the main stent and the inner layer stent by controlling the step-by-step or synchronous rotation of the front rotating knob and the rear rotating knob, and the interval time is short, thereby reducing the displacement impact caused by the release stress.

[0081] In some embodiments, the pitch of the internal thread structure of the front rotating knob is greater than the pitch of the internal thread structure of the rear rotating knob. The present application achieves the sequential release of the main bracket and the inner layer bracket by making the pitch of the internal thread structure of the front rotating knob greater than the pitch of the internal thread structure of the rear rotating knob.

[0082] In certain embodiments, the housing assembly further comprises a latch assembly;

[0083] The latch assembly includes a latch body;

[0084] The front rotating knob and the rear rotating knob are independently provided with a buckle cavity;

[0085] The latch body is slidably arranged in the buckle cavity.

[0086] When the front rotation knob and the rear rotation knob need to be rotated simultaneously, the latch body is inserted into the buckle cavity of the front rotation knob and the buckle cavity of the rear rotation knob at the same time.

[0087] In some embodiments, the distal end of the main bracket fixing tube is provided with a first hanging ear groove that cooperates with the first hanging ear structure; the first hanging ear structure cooperates with the first hanging ear groove to achieve fixation of the main bracket in the stored state.

[0088] In some embodiments, the number of the inner support bracket fixing members is the same as the number of the inner support brackets, and the distal end of the inner support bracket fixing member is provided with a second hanging ear groove that cooperates with the second hanging ear structure; the second hanging ear structure cooperates with the second hanging ear groove to achieve fixation of the inner support bracket in the stored state;

[0089] The number of the step tubes is the same as the number of the inner layer support fixing pieces, and each step tube accommodates one inner layer support fixing piece.

[0090] In some embodiments, the front rotation knob has an internal thread structure, and the internal thread structure of the front rotation knob cooperates with the external thread structure of the distal movable slider; the front rotation knob drives the distal movable slider to move axially by rotating;

[0091] The rear rotation knob has an internal thread structure, and the internal thread structure of the rear rotation knob cooperates with the external thread structure of the proximal movable slider; the rear rotation knob drives the proximal movable slider to move axially by rotating;

[0092] The threaded knob has an internal thread structure, and the internal thread structure of the threaded knob cooperates with the external thread structure of the movable screw; the threaded knob drives the movable screw to move axially by rotating.

[0093] In certain embodiments, an artificial mitral valve implant corresponding to the delivery device system provided herein includes a main stent, at least two inner stents disposed inside the main stent, and a biological valve connected to the inner stent;

[0094] Along the axial direction of the main stent, the main stent includes a main stent flange structure at the distal end, a first hanging ear structure at the proximal end, and a main stent body section connecting the flange structure and the first hanging ear structure;

[0095] Along the axial direction of the inner layer stent, the inner layer stent includes a second hanging ear structure at the proximal end, and an inner layer stent main body section connected to the second hanging ear structure;

[0096] Each inner stent is provided with a biological valve;

[0097] The gap between the main support and the inner support is provided with sewing cloth.

[0098] In the artificial mitral valve implant provided in the present application, the function of the main stent flange structure is to hang on the heart valve ring during the release process to prevent the stent from detaching from the heart valve ring during and after release; the present application does not limit the specific structure of the main stent flange structure, as long as it can achieve the relevant functions.

[0099] The artificial mitral valve implant provided herein replaces the native valve by using at least two inner stents and a corresponding bioprosthetic valve, reducing the overall valve height and avoiding obstruction of the left ventricular outflow tract. Furthermore, the non-circular artificial mitral valve implant provided herein conforms to the mitral valve annulus while avoiding compression of the aortic root, thereby preventing impact on the normal function of the aortic valve.

[0100] In the technical solution provided in this application, the "distal end" refers to the end away from the operator, that is, the end close to the patient's heart; the "proximal end" refers to the end close to the operator, that is, the end away from the patient's heart.

[0101] The artificial mitral valve implant provided in this application has at least two inner stents disposed inside the main stent, for example, two, three, four, or five, but is not limited to the listed values, and other values ​​not listed within the numerical range are also applicable. Artificial mitral valve implants provided in related art are mostly cylindrical in shape, which may cause excessive compression of the aortic root. This application effectively solves this problem by increasing the number of inner stents to at least two. Taking into account the structural complexity and cost, the preferred technical solution is to dispose two inner stents inside the main stent.

[0102] The artificial mitral valve implants provided by related technologies are mostly cylindrical in shape and have only one valve, which leads to the problem of excessive compression of the aortic root. At the same time, the valve frame is relatively high, which blocks the left ventricular outflow tract to a certain extent and has a significant impact on the intraventricular flow field. The present application uses two or more inner stents to retain the effective opening area while reducing the valve frame height. The valve is also non-circular in shape, avoiding excessive compression of the aortic root, effectively solving the above problems. Taking into account the structural complexity and cost, as a preferred technical solution, two inner stents are provided inside the main stent.

[0103] The biological valve includes a sewing cloth and at least three leaflets connected to the sewing cloth; the sewing cloth is arranged on the inner side of the inner layer stent main body segment and is connected to form a closed or non-closed ring. The sewing cloth and the sewing cloth and the inner layer stent main body segment are connected and fixed by sutures; at least three leaflets are connected to the sewing cloth by sutures, and the edges of the unsutured parts are sequentially abutted and closed to form a valve structure.

[0104] In the present application, the biological valve includes a sewing cloth and at least three leaflets connected to the sewing cloth. The number of leaflets is at least three, for example, it can be 3, 4, 5, 6 or 8, but is not limited to the listed values. Other unlisted values ​​within the numerical range are also applicable; the number of leaflets in the biological valve of the present application can be as long as it can achieve the function of the biological valve. Taking into account the structural complexity and cost, as the preferred technical solution, the number of leaflets in the biological valve is 3.

[0105] In some embodiments, in the expanded state, the height of the main bracket body section is 6-30 mm, for example, it can be 6 mm, 8 mm, 10 mm, 12 mm, 15 mm, 16 mm, 18 mm, 20 mm, 25 mm, 28 mm or 30 mm, but is not limited to the listed values, and other unlisted values ​​within the numerical range are also applicable.

[0106] In some embodiments, in the expanded state, the height of the inner layer support main section is 6-40 mm, for example, it can be 6 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm or 40 mm, but is not limited to the listed values, and other unlisted values ​​within the numerical range are also applicable.

[0107] In some embodiments, at least two inner layer stents have the same structure, and the axial directions of at least two inner layer stents are arranged in the same plane.

[0108] In some embodiments, in the stowed state, the cross-sectional area of ​​at least two inner layer supports is 40%-90% of the cross-sectional area of ​​the main support, for example, it can be 40%, 50%, 60%, 70%, 80% or 90%, but is not limited to the listed values, and other unlisted values ​​within the numerical range are also applicable.

[0109] In the artificial mitral valve implant provided in the present application, the proximal ends of the at least two inner layer stents are not connected and fixed, but the distal ends are connected and fixed, and the main segment of the inner layer stent and the adjacent main segment of the main stent need to be connected and fixed.

[0110] The connection and fixation methods include riveting and / or thread knotting, and this application does not make too many specific restrictions, as long as the connection and fixation can be achieved.

[0111] In certain embodiments, a barb structure is provided on the outer side of the main stent body segment.

[0112] The artificial mitral valve implant provided in the present application is advantageous in improving the stability of the artificial mitral valve implant in the aorta in the expanded state by providing a barb structure on the outside of the main stent body segment, thereby avoiding the adverse effects caused by displacement.

[0113] Example 1

[0114] This embodiment provides an artificial mitral valve implant 100, as shown in Figures 1, 2, 3, and 4. The artificial mitral valve implant 100 includes a main stent 101, two inner stents 102 disposed inside the main stent 101, and a biological valve 103 connected to the inner stents 102.

[0115] The two inner brackets 102 have the same structure and are arranged in the same plane. In the stowed state, the cross-sectional area of ​​the two inner brackets 102 is 60% of the cross-sectional area of ​​the main bracket 101.

[0116] Along the axial direction of the main stent 101, the main stent 101 includes a main stent flange structure 1012 at the distal end, a first hanging ear structure 1011 at the proximal end, and a main stent body section 1013 connecting the flange structure and the first hanging ear structure 1011;

[0117] Along the axial direction of the inner layer stent 102 , the inner layer stent 102 includes a second hanging ear structure 1021 at the proximal end, and an inner layer stent main body section 1022 connected to the second hanging ear structure 1021 ;

[0118] Each inner stent 102 is provided with a biological valve 103;

[0119] The bioprosthetic valve 103 includes a sewing cloth 1031 and three leaflets 1032 connected to the sewing cloth 1031. The sewing cloth 1031 is disposed inside the inner stent main section 1022, forming a closed ring. The sewing cloth 1031 and the inner stent main section 1022 are connected and fixed by sutures. The three leaflets 1032 are connected to the sewing cloth 1031 by sutures, and the edges of the unsutured portions are sequentially abutted and joined to form a valve structure.

[0120] A sewing cloth 1031 is provided in the gap between the main support body section 1013 and the inner layer support body section 1022 .

[0121] In the expanded state, the height of the main stent body section 1013 is 20 mm; in the expanded state, the height of the inner stent body section 1022 is 20 mm.

[0122] A barb structure 1014 is provided on the outside of the main stent body section 1013 .

[0123] Example 2

[0124] This embodiment provides an artificial mitral valve implant 100, as shown in Figures 1, 2, 3, and 4. The artificial mitral valve implant 100 includes a main stent 101, two inner stents 102 disposed inside the main stent 101, and a biological valve 103 connected to the inner stents 102.

[0125] The two inner brackets 102 have the same structure and are arranged in the same plane. In the stowed state, the cross-sectional area of ​​the two inner brackets 102 is 40% of the cross-sectional area of ​​the main bracket 101.

[0126] Along the axial direction of the main stent 101, the main stent 101 includes a main stent flange structure 1012 at the distal end, a first hanging ear structure 1011 at the proximal end, and a main stent body section 1013 connecting the flange structure and the first hanging ear structure 1011;

[0127] Along the axial direction of the inner layer stent 102 , the inner layer stent 102 includes a second hanging ear structure 1021 at the proximal end, and an inner layer stent main body section 1022 connected to the second hanging ear structure 1021 ;

[0128] Each inner stent 102 is provided with a biological valve 103;

[0129] The bioprosthetic valve 103 includes a sewing cloth 1031 and three leaflets 1032 connected to the sewing cloth 1031. The sewing cloth 1031 is disposed inside the inner stent main section 1022, forming a non-closed ring. The sewing cloth 1031 and the inner stent main section 1022 are connected and fixed by sutures. The three leaflets 1032 are connected to the sewing cloth 1031 by sutures, and the edges of the unsutured portions are sequentially abutted and joined to form a valve structure.

[0130] A sewing cloth 1031 is provided in the gap between the main support body section 1013 and the inner layer support body section 1022 .

[0131] In the expanded state, the height of the main stent body section 1013 is 6 mm; in the expanded state, the height of the inner stent body section 1022 is 6 mm.

[0132] A barb structure 1014 is provided on the outside of the main stent body section 1013 .

[0133] Example 3

[0134] This embodiment provides an artificial mitral valve implant 100, as shown in Figures 1, 2, 3, and 4. The artificial mitral valve implant 100 includes a main stent 101, two inner stents 102 disposed inside the main stent 101, and a biological valve 103 connected to the inner stents 102.

[0135] The two inner brackets 102 have the same structure and are arranged in the same plane. In the stowed state, the cross-sectional area of ​​the two inner brackets 102 is 90% of the cross-sectional area of ​​the main bracket 101.

[0136] Along the axial direction of the main stent 101, the main stent 101 includes a main stent flange structure 1012 at the distal end, a first hanging ear structure 1011 at the proximal end, and a main stent body section 1013 connecting the flange structure and the first hanging ear structure 1011;

[0137] Along the axial direction of the inner layer stent 102 , the inner layer stent 102 includes a second hanging ear structure 1021 at the proximal end, and an inner layer stent main body section 1022 connected to the second hanging ear structure 1021 ;

[0138] Each inner stent 102 is provided with a biological valve 103;

[0139] The bioprosthetic valve 103 includes a sewing cloth 1031 and three leaflets 1032 connected to the sewing cloth 1031. The sewing cloth 1031 is disposed inside the inner stent main section 1022, forming a closed ring. The sewing cloth 1031 and the inner stent main section 1022 are connected and fixed by sutures. The three leaflets 1032 are connected to the sewing cloth 1031 by sutures, and the edges of the unsutured portions are sequentially abutted and joined to form a valve structure.

[0140] A sewing cloth 1031 is provided in the gap between the main support body section 1013 and the inner layer support body section 1022 .

[0141] In the expanded state, the height of the main stent body section 1013 is 30 mm; in the expanded state, the height of the inner stent body section 1022 is 40 mm.

[0142] A barb structure 1014 is provided on the outside of the main stent body section 1013 .

[0143] Example 4

[0144] This embodiment provides a delivery device system suitable for the artificial mitral valve implant 100 provided in Example 1, as shown in FIG5 . Schematic diagrams of the combination of the delivery device system and the artificial mitral valve implant 100 are shown in FIG6 , FIG7 , FIG8 and FIG9 .

[0145] The conveying device system includes a central component and a housing component used in conjunction with the central component;

[0146] As shown in FIG10 , the central assembly includes an outer sleeve 204 , a distal moving slider 210 , a main stent fixing tube 201 , a fixing block 211 , a stepped tube 203 , a proximal moving slider 212 , an inner stent fixing member 202 , and a moving screw 213 ;

[0147] The distal end of the main bracket fixing tube 201 is provided with a first hanging ear groove 2011 that cooperates with the first hanging ear structure 1011; the first hanging ear structure 1011 cooperates with the first hanging ear groove 2011 to achieve the fixation of the main bracket 101 in the storage state; the proximal end of the main bracket fixing tube 201 is fixedly connected to the fixing block 211;

[0148] The number of inner support bracket fixing members 202 is the same as the number of inner support brackets 102. The distal end of the inner support bracket fixing member 202 is provided with a second hanging ear groove 2021 that cooperates with the second hanging ear structure 1021. The second hanging ear structure 1021 cooperates with the second hanging ear groove 2021 to achieve the fixation of the inner support bracket 102 in the stored state. The proximal end of the inner support bracket fixing member 202 is fixedly connected to the moving screw 213 and moves with the moving screw 213.

[0149] The number of step tubes 203 is the same as the number of inner stent fixtures 202, and each step tube 203 accommodates one inner stent fixture 202. The distal end of the step tube 203 has a cavity for accommodating the inner stent 102 in a stored state. The proximal end of the step tube 203 is fixedly connected to the proximal movable slider 212 and moves with the proximal movable slider 212. Part of the step tube 203 is accommodated in the cavity of the main stent 101 fixture.

[0150] The main stent fixing tube 201 is accommodated in the cavity of the outer sleeve 204, and the distal end has a cavity for accommodating the main stent 101 in the storage state; the proximal end of the outer sleeve 204 is fixedly connected to the distal movable slider 210 and moves with the distal movable slider 210;

[0151] As shown in FIG11 and FIG12 , the housing assembly includes a housing 220 , a front rotation knob 221 , a rear rotation knob 222 and a threaded knob 223 ;

[0152] The housing 220 accommodates the central assembly;

[0153] The front rotation knob 221 has an internal thread structure, and the internal thread structure of the front rotation knob 221 cooperates with the external thread structure of the distal movable slider 210; the front rotation knob 221 drives the distal movable slider 210 to move axially by rotating;

[0154] The rear rotation knob 222 has an internal thread structure, and the internal thread structure of the rear rotation knob 222 cooperates with the external thread structure of the proximal movable slider 212; the rear rotation knob 222 drives the proximal movable slider 212 to move axially by rotating.

[0155] The threaded knob 223 has an internal thread structure, and the internal thread structure of the threaded knob 223 cooperates with the external thread structure of the movable screw 213 ; the threaded knob 223 drives the movable screw 213 to move axially by rotating.

[0156] The conveying device system provided in this embodiment drives the distal movable slider 210 to move axially by the front rotating knob 221, thereby realizing the exposure or storage of the main support fixing tube 201 at the target position; drives the proximal movable slider 212 to move axially by the rear rotating knob 222, thereby realizing the exposure or storage of the inner layer support 102 at the target position; this application realizes the step-by-step or synchronous release of the main support 101 and the inner layer support 102 by controlling the step-by-step or synchronous rotation of the front rotating knob 221 and the rear rotating knob 222, thereby reducing the displacement effect caused by the release stress.

[0157] The housing assembly also includes a latch assembly 224 (see Figure 13); the latch assembly 224 includes a latch body 2241; the front rotation knob 221 is provided with a first snap cavity 2211; the rear rotation knob 222 is provided with a second snap cavity 2221; the latch body 2241 is slidably provided in the first snap cavity 2211 and the second snap cavity 2221 to achieve simultaneous rotation of the front rotation knob 221 and the rear rotation knob 222.

[0158] The pitch of the internal thread structure of the front rotation knob 221 is equal to the pitch of the internal thread structure of the rear rotation knob 222 .

[0159] This embodiment realizes the step-by-step or synchronous release of the main support 101 and the inner support 102 by controlling the step-by-step or synchronous rotation of the front rotation knob 221 and the rear rotation knob 222, with a short interval time, thereby reducing the displacement effect caused by the release stress.

[0160] Example 5

[0161] This embodiment provides a delivery device system for an artificial mitral valve implant 100 , which is the same as that of embodiment 4 except that the pitch of the internal thread structure of the front rotation knob 221 is greater than the pitch of the internal thread structure of the rear rotation knob 222 .

[0162] This embodiment more accurately achieves the sequential release of the main support 101 and the inner layer support 102 by making the pitch of the internal thread structure of the front rotating knob 221 greater than the pitch of the internal thread structure of the rear rotating knob 222, further reducing the displacement effect caused by the release stress.

[0163] In summary, the artificial mitral valve implant provided by the present application replaces the native valve by at least two inner-layer stents and corresponding biological valves, thereby reducing the overall valve height and avoiding blocking the left ventricular outflow tract; moreover, the artificial mitral valve implant provided by the present application can avoid squeezing the aortic root while fitting the mitral valve ring, thereby avoiding affecting the normal function of the aortic valve; the delivery device system provided by the present application drives the distal movable slider to move axially by the front rotating knob, thereby realizing the exposure or storage of the main stent fixing tube at the target position; drives the proximal movable slider to move axially by the rear rotating knob, thereby realizing the exposure or storage of the inner-layer stent at the target position; the present application realizes the step-by-step or synchronous release of the main stent and the inner-layer stent by controlling the step-by-step or synchronous rotation of the front rotating knob and the rear rotating knob, thereby reducing the displacement effect caused by the release stress.

[0164] The above description is only a specific implementation method of the present application, but the protection scope of the present application is not limited thereto. Those skilled in the art should understand that any changes or replacements that can be easily thought of by those skilled in the art within the technical scope disclosed in the present application fall within the protection scope and disclosure scope of the present application.

Claims

1. A delivery device system for an artificial mitral valve implant, the delivery device system comprising a central component and a shell component; The central component includes an outer sleeve, a distal moving slider, a main support fixing tube, a fixing block, a step tube, a proximal moving slider, an inner layer support fixing piece and a moving screw; The proximal end of the main stent fixing tube is fixedly connected to the fixing block; The proximal end of the inner layer support fixing piece is fixedly connected to the moving screw; The step tube is passed through the fixing block, the distal end of which has a cavity for accommodating the inner stent in the storage state, and the proximal end is fixedly connected to the proximal moving slider; part of the step tube is accommodated in the cavity of the main stent fixing tube; The main support fixing tube is accommodated in the cavity of the outer sleeve, and the distal end has a cavity for accommodating the main support in the storage state, and the proximal end is fixedly connected to the distal movable slider; The housing assembly includes a front rotating knob, a rear rotating knob, a threaded knob, and a housing for accommodating the central assembly; The front rotating knob drives the distal moving slider to move axially by rotating; The rear rotating knob drives the proximal moving slider to move axially by rotating; The threaded knob drives the moving screw to move axially by rotating; The pitch of the internal thread structure of the front rotating knob is greater than or equal to the pitch of the internal thread structure of the rear rotating knob.

2. The delivery device system according to claim 1, wherein: The housing assembly also includes a latch assembly; The latch assembly includes a latch body; The front rotating knob and the rear rotating knob are independently provided with a buckle cavity; The latch body is slidably arranged in the buckle cavity.

3. The delivery device system according to claim 1, wherein: The distal end of the main bracket fixing tube is provided with a first hanging ear groove matched with the first hanging ear structure; the first hanging ear structure cooperates with the first hanging ear groove to achieve fixation of the main bracket in the storage state.

4. The delivery device system according to claim 1, wherein: The number of the inner bracket fixing parts is the same as the number of the inner brackets, and the distal end of the inner bracket fixing part is provided with a second hanging ear groove matched with the second hanging ear structure; the second hanging ear structure cooperates with the second hanging ear groove to achieve the fixation of the inner bracket in the storage state; The number of the step tubes is the same as the number of the inner layer support fixings, and each step tube contains an inner layer support fixing.

5. The delivery device system according to claim 1, wherein: The front rotating knob has an internal thread structure, and the internal thread structure of the front rotating knob cooperates with the external thread structure of the distal movable slider; the front rotating knob drives the distal movable slider to move axially by rotating; The rear rotating knob has an internal thread structure, and the internal thread structure of the rear rotating knob cooperates with the external thread structure of the proximal moving slider; the rear rotating knob drives the proximal moving slider to move axially by rotating; The threaded knob has an internal thread structure, and the internal thread structure of the threaded knob cooperates with the external thread structure of the moving screw; the threaded knob drives the moving screw to move axially by rotating.

6. The delivery device system according to claim 1, wherein: The artificial mitral valve implant suitable for the delivery device system comprises a main stent, at least two inner stents arranged inside the main stent, and a biological valve connected to the inner stent; Along the axial direction of the main stent, the main stent comprises a main stent flange structure at the distal end, a first hanging ear structure at the proximal end, and a main stent body section connecting the flange structure and the first hanging ear structure; Along the axial direction of the inner layer stent, the inner layer stent comprises a second hanging ear structure at the proximal end, and an inner layer stent main body section connected to the second hanging ear structure; Each of the inner stents is provided with a biological valve; The gap between the main support and the inner support is provided with sewing cloth.

7. The delivery device system according to claim 6, wherein: In the expanded state, the height of the main stent body section is 6-30 mm.

8. The delivery device system according to claim 6, wherein: In the unfolded state, the height of the main section of the inner layer stent is 6-40 mm.

9. The delivery device system according to claim 6, wherein: In the stowed state, the cross-sectional area of ​​the at least two inner layer supports is 40%-90% of the cross-sectional area of ​​the main support.

10. The delivery device system according to claim 6, wherein: A barb structure is arranged on the outer side of the main bracket body section.

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