Valve holder, assembly and artificial heart valve loading system for delivering an artificial heart valve

Abstract

The application discloses a valve holder, an assembly and a valve loading system for delivering a prosthetic heart valve, wherein the valve holder for delivering a prosthetic heart valve comprises a connecting seat and at least one holding arm distributed on the outer periphery of the connecting seat, the at least one holding arm has a positioning structure at the distal end thereof, which matches the outflow side of the prosthetic heart valve; the at least one holding arm is provided with a frame for placing a binding wire for binding the prosthetic heart valve, the frame has a wire passing path and a wire cutting port corresponding to the wire passing path, and the wire passing path allows a wire segment of the binding wire extending along the wire passing path to be suspended. The optimized arrangement of the valve holder, the assembly and the system of the application avoids the interference of the valve holder with the holding, positioning and releasing process of the prosthetic heart valve, meanwhile, provides a structural basis for the arrangement of the surrounding matching components, optimizes the operation experience of medical staff and improves the treatment effect.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, and in particular to a valve holder, an assembly, and a prosthetic heart valve loading system for delivering a prosthetic heart valve. BACKGROUND

[0002] Aortic valve disease, particularly aortic valve stenosis, is highly morbid and places a significant burden on the world’s healthcare systems. The common treatment for diseased aortic valves is replacement with a prosthetic heart valve. The two broad categories of bioprosthetic aortic valve replacement are surgical replacement and transcatheter intervention. Younger patients (e.g., under 65 years old) and low surgical risk patients typically receive surgical heart valves due to the relative lack of long-term durability data for transcatheter valves.

[0003] Surgical prosthetic heart valves are typically connected to a valve holder, which is sutured or otherwise attached to the heart valve. In a surgical aortic valve replacement procedure, the valve holder is connected to a handle that extends 20 cm or more in the outflow direction of the valve. The combination of the handle and holder allows an assistant to hold the valve steadily while the surgeon places the annular suture in the sewing cuff of the prosthesis. By holding the handle rather than the valve, contact with the valve is minimized, reducing the chance of contamination.

[0004] Once the annular suture is placed in the sewing cuff, the valve is “parachuted” onto the suture by holding a slight tension on the suture, while the handle is used to push the valve toward the annulus. Once the valve is secured to the annulus, the valve holder and handle are typically detached from the valve, removing them from the line of sight and allowing easier access to the valve to tie off the suture.

[0005] The inventors have found that there are certain problems with current surgical valve replacement procedures. The main problem is that once the surgical valve is in place to the native annulus, the valve holder can interfere with the securement of the valve to the annulus by obstructing the surgeon’s access to the sewing ring of the valve to tie the annular suture. In some designs, the valve holder is mounted on or near the sewing ring, thereby obstructing access to the sewing ring during the procedure; in some designs, the valve holder is connected to the commissure tips and protrudes slightly outward from the commissure tips, making it difficult to access the sewing ring adjacent to the commissure, particularly during the treatment of cases of aortic stenosis.

[0006] Another common challenge with current valve holder designs is that the suture must be cut at three locations on the valve holder to remove it from the heart valve. Due to anatomical reasons, the three cut points can not all be easily accessible. Having multiple cut points can increase the procedure time and increase the risk to the patient, as sharp cutting instruments are used at multiple locations in the aorta.

[0007] The handle on most existing valve holders is typically connected to the valve holder via a threaded interface. This presents some challenges. During most aortic valve replacement procedures, the surgeon bends the handle used to hold the heart valve so that the heart valve will align coaxially with the aortic valve annulus. However, due to this bending, the handle cannot be conveniently unscrewed from the valve holder once the heart valve is landed at the annulus. Once the heart valve is at the annulus, the handle will obstruct the tying of the knots at the suture cuff. Therefore, the surgeon typically removes the handle and the valve holder together at this point by cutting the valve holder from the heart valve during the procedure. This leaves the heart valve exposed and unprotected during the rest of the procedure.

[0008] Another drawback of many current valve holder designs is that they have a relatively high profile / shape over the heart valve. This added height can present challenges when passing through tight anatomical structures. This can result in difficult heart valve implantation and potential procedural delays.

[0009] In view of the above challenges with existing valve holder designs, there is a need for a handle and valve holder system that includes the following features:

[0010] Easy access to all areas of the suture cuff;

[0011] Easy disassembly of the handle from the valve holder;

[0012] Easy disassembly of the valve holder from the valve; and

[0013] Low profile / shape to facilitate implantation. SUMMARY

[0014] The present invention provides a valve holder, assembly, and a prosthetic heart valve loading system for delivering a prosthetic heart valve that includes an improved easy access to the suture cuff to facilitate implantation, a single cut point for removing the valve holder from the heart valve, a quick release mechanism for releasing the valve holder from the handle, and an extremely low profile / shape to further facilitate implantation.

[0015] In one aspect, the present invention provides a valve holder for delivering a prosthetic heart valve, comprising a connecting base and at least one holding arm. The connecting base has an axial direction, wherein one end of the connecting base axial direction is a distal end facing the prosthetic heart valve, and the other end is a proximal end facing away from the prosthetic heart valve. The holding arms are distributed around the periphery of the connecting base, wherein the holding arms have a plurality of positioning structures at their distal ends that cooperate with the outflow side of the prosthetic heart valve.

[0016] Optionally, the at least one holding arm comprises a plurality of holding arms, which are arranged at intervals along the circumference of the connecting base.

[0017] Optionally, the holding arms are provided in plurality and are in an integral structure or a split structure with the connecting seat, and the plurality of holding arms are distributed radially along the circumference of the connecting seat.

[0018] Optionally, the positioning structure is provided in a single disc.

[0019] Optionally, the positioning structure is a clamping groove.

[0020] Optionally, each clamping groove has an opening, and the openings of all the clamping grooves are directed towards the same direction.

[0021] Optionally, the clamping groove is open in the axial direction of the valve holder, and the opening of the clamping groove is located at the distal end and is directed towards the artificial heart valve.

[0022] Optionally, each clamping groove has a wall, and the wall of the clamping groove provides a fastening force to the artificial heart valve in the radial inward direction of the connecting seat.

[0023] Optionally, the at least one holding arm is provided with a frame for accommodating the binding wire for binding the artificial heart valve, the frame has a wire passing path and a wire cutting port corresponding to the wire passing path, and the wire passing path allows the wire segment of the binding wire extending along the wire passing path to be suspended.

[0024] Optionally, the positioning structure is a clamping groove, each clamping groove has an opening, and along the axial direction of the connecting seat, the frame and the opening of the clamping groove are located on opposite sides of each of the at least one holding arm.

[0025] Optionally, each of the at least one holding arm is further provided with at least one wire passing hole for passing the binding wire for binding the artificial heart valve.

[0026] Optionally, the at least one holding arm includes a plurality of holding arms, and a wire passing groove for passing the binding wire is provided between adjacent two holding arms.

[0027] Optionally, the frame includes at least a pair of supporting seats arranged oppositely, and the gap between the pair of supporting seats serves as the wire cutting port.

[0028] Optionally, each supporting seat is provided with a wire clamping groove for passing the binding wire, and the wire passing path is between the two wire clamping grooves.

[0029] Optionally, the connecting seat is provided with an insertion hole extending in the axial direction.

[0030] Optionally, the connecting seat is provided with a clamping portion.

[0031] Optionally, the at least one holding arm is configured as a single disc, and the positioning structure is provided at the distal end thereof for cooperating with the outflow side of the artificial heart valve.

[0032] The application also discloses a component for delivering an artificial heart valve, comprising a valve holder and a control handle detachably connected with the valve holder, wherein the valve holder comprises:

[0033] a connecting seat having an axial direction, one end of the axial direction of the connecting seat being a distal end facing the artificial heart valve, and the other end being a proximal end facing away from the artificial heart valve; and

[0034] at least one holding arm distributed on the outer periphery of the connecting seat, the at least one holding arm having a positioning structure at the distal end thereof matched with the outflow side of the artificial heart valve;

[0035] and wherein the control handle comprises:

[0036] a plug-in part for detachably plugging in the valve holder, and the plug-in part has a plugged-in state and a separated state with the valve holder;

[0037] a limiting part connected with the plug-in part for limiting the valve holder in the plugged-in state, and the connecting part between the limiting part and the plug-in part is a deformable structure for releasing the limitation on the valve holder; and

[0038] a control part connected with at least one of the limiting part and the plug-in part.

[0039] Optionally, the deformable structure is a resettable hinge mechanism or is made of an elastic material.

[0040] Optionally, the plug-in part is provided with an outwardly protruding blocking part, and in the plugged-in state, the blocking part is abutted against the valve holder for limiting.

[0041] Optionally, one end of the limiting part is a connecting end connected with the plug-in part, and the other end is a limiting end matched with the valve holder; and the limiting end is hook-shaped.

[0042] The application also discloses an artificial heart valve loading system, comprising:

[0043] an artificial heart valve having an outflow side and a plurality of joint parts, and

[0044] a valve holder, wherein the valve holder comprises:

[0045] a connecting seat having an axial direction, one end of the axial direction of the connecting seat being a distal end facing the artificial heart valve, and the other end being a proximal end facing away from the artificial heart valve; and

[0046] at least one holding arm distributed around the outer periphery of the connecting seat, each of the at least one holding arm having a positioning structure at its distal end to cooperate with the outflow side of the artificial heart valve; and

[0047] wherein the artificial heart valve and the valve holder are positioned against each other and connected to each other by the binding of the binding wire.

[0048] Optionally, each of the at least one holding arm is provided with a frame for disposing the binding wire for binding the artificial heart valve, the frame having a wire passing path and a wire cutting port corresponding to the wire passing path, and the wire passing path allows the wire segment of the binding wire extending along the wire passing path to be suspended; all wire segments of the binding wire pass through the wire cutting port directly or indirectly.

[0049] Optionally, the artificial heart valve has an axial direction, and one end of the axial direction of the artificial heart valve is provided with a suture ring, and the other end is positioned against the valve holder.

[0050] The present application also discloses an artificial heart valve loading system, comprising:

[0051] an artificial heart valve having an outflow side and a plurality of joint parts, and

[0052] a valve holder, wherein the valve holder comprises:

[0053] a connecting seat having an axial direction, wherein one end of the axial direction of the connecting seat is a distal end facing the artificial heart valve, and the other end is a proximal end facing away from the artificial heart valve; and

[0054] at least one holding arm distributed around the outer periphery of the connecting seat, each of the at least one holding arm having a positioning structure at its distal end to cooperate with the outflow side of the artificial heart valve; and

[0055] the joint tip of the artificial heart valve cooperating with the positioning structure is deflected radially inward by 0.5-5mm.

[0056] In another aspect, the present application also discloses a control handle joint for detachably connecting with a valve holder, the control handle joint comprising: a plug-in part for detachably plugging with the valve holder, and the plug-in part and the valve holder both have a plugged state and a separated state. A limiting part is connected with the plug-in part for limiting the valve holder in the plugged state, and the connecting part of the limiting part and the plug-in part is a deformable structure to release the limitation of the valve holder; a control part is connected with at least one of the limiting part and the plug-in part.

[0057] Optionally, the deformable structure is a resettable hinge mechanism, or uses an elastic material.

[0058] Optionally, the insertion part is a rod, one end of which is an insertion end matched with the valve holder, and the other end is adjacent to the connecting part of the limiting part.

[0059] Optionally, the insertion end is a round head structure.

[0060] Optionally, the insertion part is provided with an outward protruding blocking part, and the blocking part is in abutment with the valve holder in the insertion state.

[0061] Optionally, the blocking part extends around the outer periphery of the insertion part.

[0062] Optionally, one end of the limiting part is a connecting end connected with the insertion part, and the other end is a limiting end matched with the valve holder.

[0063] Optionally, the limiting end is a hook.

[0064] Optionally, the holding part is fixedly connected with the limiting part.

[0065] Optionally, the holding part and the limiting part are both rod-shaped and have the same extension direction.

[0066] Optionally, the limiting part and the insertion part are arranged in parallel.

[0067] Optionally, the insertion part, the limiting part and the holding part are an integral structure.

[0068] Optionally, the insertion end extends 2% to 30% beyond the limiting end in the axial direction.

[0069] The application also discloses a delivery assembly for an artificial heart valve, which comprises the valve holder and the control handle joint as described above, and the valve holder is detachably connected with the control handle joint.

[0070] Optionally, the valve holder is provided with an insertion hole extending in the axial direction and used for matching with the control handle joint.

[0071] Optionally, the insertion hole is a through hole.

[0072] Optionally, the valve holder is provided with a clamping part used for matching with the control handle joint.

[0073] Optionally, the clamping part is a stepped structure.

[0074] The application also discloses a control handle, which comprises a handle, a connecting shaft with ductility, and the control handle joint as described above, one end of the connecting shaft is connected with the handle, and the other end of the connecting shaft is connected with the control handle joint.

[0075] Optionally, the connecting shaft can be made of metal or plastic or other materials with certain rigidity.

[0076] Optionally, the connecting shaft is bonded to the handle and inserted into the fitting hole provided on the control handle joint.

[0077] The application also discloses a prosthetic heart valve loading system, which comprises the valve holder and the control handle as described above, wherein the control handle comprises a handle, a connecting shaft with ductility, and the control handle joint as described above, one end of the connecting shaft is connected with the handle, and the other end of the connecting shaft is connected with the control handle joint, and the valve holder is detachably connected with the control handle joint.

[0078] The application also discloses a valve holder for conveying a prosthetic heart valve, which comprises a connecting seat and at least one holding arm distributed around the outer periphery of the connecting seat, the at least one holding arm is provided with a frame for winding a binding wire for binding the prosthetic heart valve, the frame has a wire passing path and a wire cutting port corresponding to the wire passing path, and the wire passing path allows a wire segment of the binding wire extending along the wire passing path to be suspended; all wire segments of the binding wire pass through the wire cutting port directly or indirectly.

[0079] Optionally, the holding arm is further provided with a wire passing hole for passing the binding wire for binding the prosthetic heart valve.

[0080] Optionally, at least one holding arm is provided with a knot hole for fixing the binding wire.

[0081] Optionally, the knot holes are arranged in pairs.

[0082] Optionally, a wire pressing groove for guiding the binding wire is arranged between two adjacent holding arms.

[0083] Optionally, a radially outwardly convex extension member is fixed to the outer periphery of the connecting seat, and the wire pressing groove is arranged in the extension member.

[0084] Optionally, the frame is fixed to the holding arm.

[0085] Optionally, the frame at least comprises a pair of supporting seats arranged oppositely, and the gap between the pair of supporting seats serves as the wire cutting port.

[0086] Optionally, each supporting seat is provided with a wire clamping groove for guiding the binding wire, and the wire clamping grooves serve as the wire passing path for suspending the binding wire.

[0087] Optionally, along the circumference of the connecting seat, the same pair of supporting seats are distributed on two opposite sides of the holding arm.

[0088] Optionally, each supporting seat is provided with a wire passing hole for guiding the binding wire.

[0089] Optionally, the wire passing hole is located at the connecting part of the supporting seat and the holding arm.

[0090] Optionally, the at least one holding arm is provided with a wire blocking member for limiting the extension tendency of the binding wire.

[0091] Optionally, the holding arm has a plurality of clamping slots at its distal end for cooperating with the outflow side of the artificial heart valve, and the wire pressing groove is oriented in the same direction as the clamping slots.

[0092] Optionally, the holding arm has opposite top and bottom sides, and the height H1 of the frame relative to the top side of the holding arm is 1-4.5 mm.

[0093] Optionally, the height H2 of the proximal end of the connecting seat relative to the top side of the holding arm is 0.5-2 mm.

[0094] Optionally, the proximal end of the connecting seat is lower than the highest point of the frame relative to the top side of the holding arm.

[0095] Optionally, the height of the wire blocking member is 10%-50% lower than that of the connecting seat.

[0096] Optionally, the height H3 of the bottom surface of the clamping slot to the highest point of the frame is 3.1 mm.

[0097] Optionally, the height H4 between the bottom surface of the clamping slot and the proximal end of the connecting seat is 2.1 mm.

[0098] The application also discloses an artificial heart valve loading system comprising an artificial heart valve and a valve holder, wherein the valve holder is the valve holder in the above technical solution, and the artificial heart valve and the valve holder are positioned in abutment and connected to each other by the binding of the binding wire.

[0099] Optionally, all the binding wires pass through the wire cutting port directly or indirectly.

[0100] Optionally, at least one end of the binding wire is fixed to the valve holder.

[0101] Optionally, at least one end of the binding wire is fixed to the valve holder by at least one of the following means: connection, adhesion and knotting.

[0102] The application also discloses a method for holding an artificial heart valve, comprising:

[0103] Abutting the outflow side of the artificial heart valve with the valve holder;

[0104] Binding and fixing the artificial heart valve and the valve holder by the binding wire.

[0105] The application also discloses a method for positioning an artificial heart valve, comprising:

[0106] Combining the artificial heart valve, the valve holder and the handle with each other;

[0107] Positioning the prosthetic heart valve.

[0108] Optionally, the method further comprises disengaging the holder and the handle from the prosthetic heart valve in any order.

[0109] Optionally, the method further comprises disengaging the holder and the handle from the prosthetic heart valve in any order.

[0110] The application also discloses a method for releasing a prosthetic heart valve, comprising:

[0111] Positioning the prosthetic heart valve loaded on the holder;

[0112] Cutting the binding line between the holder and the prosthetic heart valve;

[0113] Disengaging the holder together with the binding line from the prosthetic heart valve.

[0114] Optionally, the holder comprises a connecting seat and a plurality of holding arms distributed on the outer periphery of the connecting seat, and the holding arms are provided with:

[0115] Positioning structure for combining with the prosthetic heart valve;

[0116] Frame for circumventing the binding line of the prosthetic heart valve and providing a suspended winding path, and the frame is provided with a cutting port corresponding to the position of the winding path;

[0117] Disengaging comprises cutting the binding line in the cutting port to release the constraint path, so as to separate the holder together with the binding line from the prosthetic heart valve.

[0118] The application also discloses an assembly for delivering a prosthetic heart valve, for implementing the above-mentioned holding method or positioning method or releasing method, and the assembly comprises a holder and a control handle detachably connected with the holder,

[0119] Wherein the holder comprises:

[0120] Connecting seat, the connecting seat has an axial direction, one end of the axial direction of the connecting seat is a distal end facing the prosthetic heart valve, and the other end is a proximal end facing away from the prosthetic heart valve; and

[0121] At least one holding arm distributed on the outer periphery of the connecting seat, and the at least one holding arm has a positioning structure matched with the outflow side of the prosthetic heart valve at the distal end thereof;

[0122] And wherein the control handle comprises:

[0123] Plug-in part for detachable plugging with the holder, and the plug-in part has a plugging state and a disengaging state with the holder;

[0124] A limiting part connected with the insertion part for limiting the valve holder in the insertion state, and a connecting part between the limiting part and the insertion part is a deformable structure to release the limitation of the valve holder.

[0125] A control part connected with at least one of the limiting part and the insertion part.

[0126] The application also discloses a prosthetic heart valve loading system for implementing the above-mentioned holding method or positioning method or releasing method, which comprises:

[0127] A prosthetic heart valve having an outflow side and a plurality of engaging parts, and

[0128] A valve holder, wherein the valve holder comprises:

[0129] A connecting seat having an axial direction, wherein one end of the connecting seat in the axial direction is a distal end facing the prosthetic heart valve, and the other end is a proximal end facing away from the prosthetic heart valve; and

[0130] At least one holding arm distributed on the outer periphery of the connecting seat, each of the at least one holding arm has a positioning structure at the distal end thereof matched with the outflow side of the prosthetic heart valve; and

[0131] The prosthetic heart valve and the valve holder are positioned against each other and connected to each other by the binding of the binding wire.

[0132] The application also discloses a prosthetic heart valve loading system for implementing the above-mentioned holding method or positioning method or releasing method, which comprises:

[0133] A prosthetic heart valve having an outflow side and a plurality of engaging parts, and

[0134] A valve holder, wherein the valve holder comprises:

[0135] A connecting seat having an axial direction, wherein one end of the connecting seat in the axial direction is a distal end facing the prosthetic heart valve, and the other end is a proximal end facing away from the prosthetic heart valve; and

[0136] At least one holding arm distributed on the outer periphery of the connecting seat, each of the at least one holding arm has a positioning structure at the distal end thereof matched with the outflow side of the prosthetic heart valve; and

[0137] The engaging tip of the prosthetic heart valve matched with the positioning structure is deflected radially inward by 0.5-5 mm.

[0138] The valve holder of the present application is optimized so as to avoid the interference of the valve holder to the holding, positioning and releasing process of the artificial heart valve, meanwhile providing structural basis for the arrangement of the surrounding matching components, optimizing the operation experience of the medical staff and improving the treatment effect.

[0139] The specific beneficial technical effects will be further explained in the specific embodiments in combination with specific structures or steps. BRIEF DESCRIPTION OF DRAWINGS

[0140] Figure 1a It is a schematic view of an embodiment of the valve holder of the present application;

[0141] Figure 1b It is a schematic view of the positioning structure of the valve holder in Figure 1a

[0142] Figure 2a It is another perspective view of the valve holder shown in Figure 1a

[0143] Figure 2b It is an enlarged schematic view of the frame of the valve holder in Figure 2a

[0144] Figure 3a It is a side view of the valve holder shown in Figure 2a

[0145] Figure 3b It is a cross-sectional schematic view of the valve holder in Figure 2a

[0146] Figure 3c It is a cross-sectional view of the valve holder in Figure 3a

[0147] Figure 4 It is a schematic view of the wire binding and threading structure in Figure 2a

[0148] Figure 5 It is an enlarged schematic view of the wire channel of the valve holder shown in Figure 1a

[0149] Figure 6a It is a schematic view of an embodiment of the control handle joint of the present application;

[0150] Figure 6b It is another perspective view of the control handle joint in Figure 6a

[0151] Figure 6c It is yet another perspective view of the control handle joint in Figure 6a

[0152] Figure 7a It is a schematic view of an embodiment of the artificial heart valve;​​​​​​​​​​

[0153] Figure 7b is an enlarged sectional view of the structure at the location indicated by the letter A in Figure 7a

[0154] Figure 7c is a partial view of a holder for a prosthetic heart valve in conjunction with the prosthetic heart valve;

[0155] Figure 8a is a schematic view of the holder for a prosthetic heart valve in Fig. 1 and the control handle joint together; Figures 6a-6c

[0156] Figure 8b is a schematic view of the holder for a prosthetic heart valve and the control handle joint from another perspective as indicated by the letter B in Figure 8a

[0157] Figure 8c is a sectional view of the holder for a prosthetic heart valve and the control handle joint as indicated by the letter C in Figure 8b

[0158] Figure 8d is a side view of the holder for a prosthetic heart valve and the control handle joint as indicated by the letter D in Figure 8c

[0159] Figure 9a is a schematic view of a prosthetic heart valve connected to the holder for a prosthetic heart valve and the holder for a prosthetic heart valve connected to the control handle joint;

[0160] Figure 9b is an exploded view of the holder for a prosthetic heart valve as indicated by the letter E in Figure 9a

[0161] Figure 10a is a schematic view of an embodiment of the delivery device for a prosthetic heart valve of the present invention comprising a control handle connected to the holder for a prosthetic heart valve;

[0162] Figure 10b is another different schematic view of the delivery device for a prosthetic heart valve of the present invention comprising a control handle connected to the holder for a prosthetic heart valve; and Figure 10a

[0163] is a schematic view of another embodiment of the holder for a prosthetic heart valve of the present invention. Figure 11 DETAILED DESCRIPTION The technical solutions in the embodiments of the present disclosure will be described below with reference to the drawings in the embodiments of the present disclosure. The described embodiments are only some of the embodiments of the present application, not all the embodiments.

[0164]

[0165] ​​​​​​​It should be noted that when a component is said to be "connected" to another component, it can be directly connected to the other component or it can be connected to a component in between. When a component is said to be "set on" another component, it can be directly set on the other component or it may be set to a component in between.

[0166] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0167] Reference Appendix Figure 1a To be continued Figure 5 As shown, this application discloses a method for implanting an artificial heart valve 2 (such as...). Figure 7a The valve holder 1 (shown) includes a connecting seat 11 and holding arms 12 distributed around the outer periphery of the connecting seat 11. In this embodiment, multiple holding arms 12 are arranged at intervals around the connecting seat 11. The core purpose of the holding arms 12 is to achieve the relative position of the artificial heart valve 2 and the valve holder 1, so that the holding arms 12 can be distributed or spaced apart to satisfy the mechanical relationship or equivalent mechanical relationship between the artificial heart valve 2 and the valve holder 1.

[0168] In this embodiment, the arm 12 and the connecting seat 11 are an integral structure. In other embodiments, the arm and the connecting seat may also be separate structures. In the case of a separate structure, the connection between the arm and the connecting seat needs to meet a certain connection strength. Specifically, the arm and the connecting seat can be fixedly connected or detachably connected. In the case of a fixed connection, the arm and the connecting seat are manufactured independently and assembled using connection methods that are not easy to disassemble, such as welding, bonding, hot melting, or riveting. In the case of a detachable connection, the arm and the connecting seat are manufactured independently and assembled using connection methods that are easy to disassemble and then reconnect, such as screwing, snap-fitting, or magnetic attraction.

[0169] In this embodiment, the connecting seat 11 has an axial direction. In use, one end of the connecting seat 11 along the axial direction is the distal end 112 facing the artificial heart valve, and the other end is the proximal end 113 facing away from the artificial heart valve. By connecting the valve holder 1 to the artificial heart valve 2 (e.g., Figure 7a The valve holder 1 is configured to engage with the outflow side 92 of the artificial heart valve 2 (as shown) to prevent the valve holder 1 from affecting the holding, positioning, and release of the artificial heart valve 2. In particular, the valve holder 1 is configured to engage with the outflow side 92 of the artificial heart valve 2 through a positioning structure 13 provided at the distal end 112 of the holding arm 12 of the valve holder 1.

[0170] The positioning structure 13 can adopt a structure facilitating the separation of the valve holder 1 and the prosthetic heart valve 2, such as a clamping structure, a limiting structure, an adhesive structure, a field effect structure (such as a magnetic field or an electric field effect structure), and the like. In the present embodiment, the positioning structure 13 is a clamping groove 131, as shown in Figure 1b

[0171] The clamping groove 131 can constrain the relative position relationship between the valve holder 1 and the prosthetic heart valve 2 while facilitating the separation of the valve holder 1 and the prosthetic heart valve 2, thereby avoiding unnecessary damage to the prosthetic heart valve 2 caused by the valve holder 1 during the release of the prosthetic heart valve 2. It is worth noting that, compared with the corresponding positioning structure in the prior art, the clamping groove 131 in the present embodiment does not need to constrain the prosthetic heart valve 2 in all directions. In the present embodiment, the clamping groove 131 is open in the axial direction of the valve holder 1, and the slot opening 132 of the clamping groove 131 is located at the distal end 112 and faces the prosthetic heart valve 2. It can be understood that, when the valve holder 1 and the prosthetic heart valve 2 are assembled with each other, the axial direction of the valve holder 1 coincides with the axial direction of the prosthetic heart valve 2. In other embodiments, a blocking structure can be provided at the slot opening 132 of the clamping groove 131 to prevent the prosthetic heart valve 2 from being detached from the valve holder 1, thereby improving the fixing effect. In the present embodiment, the slot opening 132 of the clamping groove 131 allows the prosthetic heart valve 2 to be detached in the axial direction of the valve holder 1. The clamping groove 131 focuses on the radial constraint of the prosthetic heart valve 2. Specifically, the slot wall 133 of the clamping groove 131 exerts a pre-tightening force (i.e., the aforementioned fastening force) on the prosthetic heart valve 2 along the radial direction of the connecting seat 11 inwardly.

[0172] The slot wall 133 of the clamping groove 131 can achieve the mutual positioning of the valve holder 1 and the prosthetic heart valve 2, and the radial inward deflection of the stent of the prosthetic heart valve 2 by exerting an action force on the prosthetic heart valve 2 along the radial direction of the connecting seat 11 inwardly. Through the engagement with the clamping groove 131, the prosthetic heart valve 2 can be deformed relative to its natural state towards its own axial direction, thereby making it easier to insert the heart valve 2 through the surgical opening and advance to the annulus, thereby allowing the surgeon to more easily access the suturing ring 21 for knotting while still providing protection for the heart valve and the valve leaflets. This static deflection of the engagement portion of the prosthetic heart valve 2 radially inwardly when connected to the valve holder 1 is an important aspect of the present application. For example, the engagement tip of the prosthetic heart valve 2 can be deflected radially inwardly by 0.5-5 mm. Furthermore, by matching the arrangement of the stent material of the prosthetic heart valve 2, time dependence is reduced or even overcome.

[0173] ​The positioning of the card slot 131 itself depends on the arrangement of the holding arms 12. In the present embodiment, the plurality of holding arms 12 are distributed radially along the circumference of the connecting seat 11. Each holding arm 12 forms a positioning plane relative to the connecting seat 11, and the card slot 131 defined on each holding arm 12 can determine the spatial position of the prosthetic heart valve 2 relative to the positioning plane, thereby facilitating the holding, positioning and releasing of the prosthetic heart valve 2. In the present embodiment, the holding arms 12 are uniformly distributed on the outer circumference of the connecting seat 11 to form a regular and controllable positioning plane, facilitating the assembly between the prosthetic heart valve 2 and the valve holder 1. Alternatively, in other embodiments, the holding arms are non-uniformly distributed (e.g., spaced at different intervals) on the outer circumference of the connecting seat 11 to avoid the corresponding anatomical structures.

[0174] The number of holding arms 12 is 2-12. Preferably, the number of holding arms 12 can be adjusted to 3-10 or 3-8 or 4-12 or 4-10.

[0175] The increase in the number of card slots 131 can effectively improve the positioning effect of the valve holder 1 on the prosthetic heart valve 2. In the present embodiment, one card slot 131 is provided on each holding arm 12. Meanwhile, the openings 132 of all the card slots 131 are oriented in the same direction. Here, "the same direction" can refer to the geometric concept of the same direction, or can refer to the same trend of orientation, for example, the orientation extension lines of the openings 132 all point to the axial direction of the valve holder 1 and converge at a point. In this scheme, the orientations of the openings 132 are not actually the same in geometric space, but they have the same logical rule and should also be understood as "the same" in the above description. In other embodiments, not all holding arms 12 are provided with card slots, but only the holding arms 12 that need to position the prosthetic heart valve 2 are provided with card slots, so as to reduce the amount of processing required.

[0176] Referring to FIG. 1, Figure 3c As shown in FIG. 1, the depth D1 of the card slot 131 is 0.1-2.5 mm. Preferably, the depth D1 of the card slot 131 can be adjusted to 0.6-2 mm or 1-2.3 mm or 0.8-2.3 mm.

[0177] The inventors have also found that the existing valve holders available on the market must cut the binding line at 3 or more positions on the valve holder to achieve separation from the prosthetic heart valve. Due to anatomical reasons, the above-mentioned multiple positions for cutting the binding line are not all easily accessible, thereby increasing the operation time. In addition, the cutting tool is usually sharp, which can cause damage to the patient's anatomical structure and increase the patient's surgical risk.

[0178] To solve this problem, referring to FIG. 1, Figure 1a to FIG. 1, Figure 5As shown, preferably, one of the holding arms 12 of the holder 1 is further provided with a frame 14 for binding the binding thread 4 of the artificial heart valve 2. In this embodiment, the frame 14 and the notch 132 of the clamping slot 131 are located at the opposite sides of the holding arm 12. The frame 14 is provided with a thread passing path 141 and a thread cutting port 142 corresponding to the position of the thread passing path 141, and the thread passing path 141 allows the thread segment of the binding thread 4 extending thereon to be suspended on the thread passing path.

[0179] The provision of the thread cutting port 142 reduces the trouble and surgical risk caused by thread cutting operation. Specifically, the thread cutting port 142 can be independently provided and can be provided with corresponding protection structure to guide and protect the cutting tool; in addition, the extension path of the binding thread 4 is single and passes through the thread cutting port 142, so that a single cutting operation at the thread cutting port 142 can achieve the release of the binding thread, thereby achieving the separation of the holder 1 and the artificial heart valve 2, thereby effectively reducing the operation time. Medical staff can adjust the implantation direction of the artificial heart valve 2 according to the anatomical structure to facilitate the operation of the thread cutting port 142, thereby reducing the surgical risk of the patient.

[0180] In this embodiment, the frame 14 is fixed on the holding arm 12 and at least includes a pair of supporting seats 143a, 143b arranged oppositely. Specifically, along the circumference of the connecting seat 11, the two supporting seats 143a, 143b are respectively distributed at the two opposite sides of the holding arm 12, and the gap between the pair of supporting seats 143a, 143b serves as the thread cutting port 142. Each supporting seat 143a, 143b is provided with a thread clamping groove 144 for threading the binding thread 4, and the two thread clamping grooves 144 of the two supporting seats 143a, 143b form the thread passing path 141. In addition, each supporting seat 143a, 143b is provided with a thread passing hole 145 for threading the binding thread 4. In this embodiment, the thread passing hole 145 is located at the bottom of the supporting seat 143a, 143b, and the supporting seat 143a, 143b extends from the holding arm 12 at the bottom thereof.

[0181] In order to improve the binding ability of the holding arm 12 to the binding thread 4, preferably, the holding arm 12 is further provided with at least one thread passing hole 121 for threading the binding thread 4 of the artificial heart valve 2. Therefore, after cutting the binding thread 4, all the fragments of the binding thread 4 are still attached to the holder 1, which can prevent any fragments of the binding thread 4 from remaining in the patient's body. More preferably, at least one holding arm 12 is provided with a pair of thread knot holes 122 for fixing the binding thread 4. The thread knot hole 122 can conveniently retain the fragments of the binding thread 4 on the holder 1. In this embodiment, the pair of thread knot holes 122 are defined on the two holding arms 12.

[0182] It can be understood that the arrangement of the binding thread 4 is very important, and improper threading of the binding thread 4 can cause interference and even reduce the binding effect. Therefore, preferably, a thread passing groove 41 for threading the binding thread 4 is provided between the two adjacent holding arms 12, as shown inFigure 4 The wire slot 41 has the same orientation or opening as the clamping slot 131. In this embodiment, the connecting seat 11 is fixed with a radially outwardly protruding extension 42, and the wire slot 41 is formed in each corresponding extension 42.

[0183] The valve holder 1 can also be provided with a structure on the holding arm 12 to restrict the wire passage. For example, in this embodiment, at least one holding arm 12 is provided with a wire blocking piece 43 for limiting the extension trend of the binding wire 4, as shown in Figure 4 .

[0184] In use, the valve holder 1 needs to be controlled through the control handle (to be described in detail later). In this embodiment, as shown in Figure 3c , the connecting seat 11 is provided with an insertion hole 15 extending in the axial direction, which is used in cooperation with the control handle joint 3 of the control handle. Specifically, the connecting seat 11 is generally cylindrical, and the insertion hole 15 is a through hole penetrating the connecting seat 11 in the axial direction. In this embodiment, the end of the connecting seat 11 at the bottom side has a converging structure in the outer diameter. The converging structure in the outer diameter can be formed synchronously in the inner and outer diameters of the cylinder, or can be manifested as an outer wall chamfer 111 as shown in Figure 3c . Further, as shown in Figure 1a , the connecting seat 11 is provided with a clamping portion 16 for cooperation with the control handle joint 3. In this embodiment, the clamping portion 16 is a stepped structure.

[0185] This embodiment optimizes the valve holder 1, avoids the interference of the valve holder 1 with the process of holding, positioning and releasing the artificial heart valve 2, and provides a structural basis for the setting of the surrounding cooperating components, thereby optimizing the operation experience of medical staff and improving the treatment effect.

[0186] Referring to the accompanying drawings Figure 3a to Figure 3c , in this embodiment, along the axial direction of the connecting seat 11, the holding arm 12 is located in the middle of the connecting seat 11. Along the axial direction of the connecting seat 11, the holding arm 12 has opposite top and bottom sides 123 / 124. The height H1 of the frame 14 relative to the top side 123 of the holding arm 12 is 1 mm to 4.5 mm. The height H2 of the proximal end 113 of the connecting seat 11 relative to the top side 123 of the holding arm 12 is 0.5 mm to 2 mm. The proximal end 113 of the connecting seat 11 is lower than the highest point of the frame 14 relative to the top side 123 of the holding arm 12. The height of the wire blocking piece 43 is 10% to 50% lower than that of the connecting seat 11.

[0187] In the accompanying drawings Figure 3cIn the illustrated embodiment, the height H3 from the bottom surface of the slot 131 to the highest point of the frame 14 is only 3.1 mm. The height H4 between the bottom surface of the slot 131 and the proximal end 113 of the connector 11 is only 2.1 mm. Despite the compact internal anatomy of the patient, the flattened external dimensions of the valve holder 1 make it easier to insert the artificial heart valve 2 and the valve holder 1, and provide better visibility for medical staff during the implantation of the artificial heart valve 2.

[0188] The advantages of the flattened, low-profile valve holder 1 are improved visibility and easier passage through narrow anatomical spaces. Furthermore, the improved visibility of the valve holder 1 allows for easier insertion into the patient along with the artificial heart valve 2, resulting in reduced operation time and improved safety. Compared to the relatively taller and larger profile of existing technologies, the valve holder 1 in this embodiment avoids the difficulties in valve implantation and potential operational delays caused by increased height.

[0189] In other embodiments, such as Figure 11 As shown, the positioning structure 13 can be housed in a single disc, which can be considered a single retaining arm or disc 12', constructed as a generally circular disc rather than multiple retaining arms 12 arranged in the aforementioned spaced-out manner. The aforementioned threading hole 121 can be defined in the disc 12' for threading the binding suture 4 to connect to the artificial heart valve 2. Similarly, a knot hole 122 can also be provided for securing the binding suture 4.

[0190] The aforementioned valve holder 1 can be used to load... Figure 7a and Figure 7b The exemplary illustration shows an artificial heart valve 2. It should be noted that the valve holder 1 disclosed herein is not limited to use with the artificial heart valve 2, which will be described in detail below, but can be used with any other suitable artificial heart valve.

[0191] The artificial heart valve 2 has an axial direction, with one end of the axial direction being the blood inflow side 91 and the other end being the blood outflow side 92. The artificial heart valve 2 includes multiple leaflets 29, a support structure 22, and a frame 26 for maintaining the configuration of the leaflets 29. The holding arm 12 of the valve holder 1 is used to engage with the engagement tip 24 at the proximal end of the frame 26 of the artificial heart valve 2.

[0192] In this embodiment, the support structure and frame 26 are generally annular, with a blood flow channel inside the annulus. The support structure 22 has opposing inflow sides 91 and outflow sides 92 along the annular axis. Specifically, the support structure 22 includes a first annular band 23 and a second annular band 25. The second annular band 25 has multiple extension rods 250 extending toward the outflow side 92 and spaced apart from each other circumferentially, serving as engagement tips 24 proximal to the support frame 26. The engagement portions of adjacent leaflets 29 engage with corresponding engagement tips 24. Multiple leaflets 29 are connected to the support structure 22 to control blood flow.

[0193] When attached to the valve holder 1, the metal frame 26 does not become stress-relaxed or permanently deformed over time. In this embodiment, the support structure 22 has a suture ring 21 fixed at the inflow side 91, and the annular band and the suture ring 21 are generally covered by a first covering layer 27. The metal frame 26 is typically covered by a second covering layer 28.

[0194] When the artificial heart valve 2 is loaded onto the valve holder 1, the frame engagement tip 24, covered by the second covering layer 28, is inserted into the slot 131 of the holding arm 12, so that the artificial heart valve 2 is detachably connected to the holding arm 12 through the slot 131. Figure 7c As shown. After the artificial heart valve 2 is loaded onto the valve holder 1, the valve holder 1 is positioned at the end of the artificial heart valve 2 away from the suture ring 21, so as to prevent the valve holder 1 from interfering with the suture ring 21 during the holding, positioning, and release of the artificial heart valve 2. As described above, the valve holder 1 is radially pulled into the engagement tip 24 by about 0.5-5 mm to better approach the suture ring 21.

[0195] Reference Appendix Figure 1a To be continued Figure 5 Appendix Figures 7a-7c As shown in 9b, the present invention also discloses a system comprising an artificial heart valve 2 and a valve holder 1 as described above, wherein the artificial heart valve 2 and the valve holder 1 are positioned against each other and connected to each other by binding wire 4.

[0196] All binding threads 4 pass directly or indirectly through the thread cut 142. At least one end of the binding thread 4 is fixed to the valve holder 1. At least one end of the binding thread 4 is fixed to the valve holder 1 by at least one method, such as a connector, adhesive, or knot.

[0197] The binding thread should be configured to provide a stable connection with the valve holder 1 and to ensure that fragments of the binding thread 4, even after being cut, remain on the valve holder 1. This will be discussed in conjunction with the attached diagram. Figure 4 The embodiments described herein exemplify one winding method; however, it should be noted that the winding method is not limited to this, and other appropriately modified winding methods can be used to arrange the wire.

[0198] Reference AppendixFigure 4 In the figure, the binding thread 4 starts to be wound from the upper left arm 12. First, it is wound and fixed at the knot hole 122 on the upper left arm 12. Then, it enters one of the thread holes 121 along the top surface 123 of the upper left arm 12d. Then, it is sewn to the part of the artificial heart valve 2 located there. Finally, it is passed back to the top surface 123 of the upper left arm 12 through another thread hole 121.

[0199] The binding wire 4 continues along the top surface 123 of the upper left arm 12, along one of the wire stoppers 43, and enters the frame 14 through the wire routing groove 41 in the lower left corner of the figure. Specifically, the binding wire 4 passes through the wire clamping grooves 144 on the two supports 143a and 143b in sequence, forming a suspended wire segment along the wire path 141 corresponding to the wire cutting opening 142.

[0200] Thread 4 continues through Figure 4 The wire-passing hole 145 of the support 143b on the right side passes through the wire-cutting opening 142 and extends along the top surface 123 of the corresponding holding arm 12 until it enters the wire-cutting opening 142. Figure 4 The lower center thread hole 121 is sewn to the part of the artificial heart valve 2 located there, and then threaded back to the top surface 123 of the corresponding arm 12 through another thread hole 121.

[0201] The binding line 4 continues along the top surface 123 of the corresponding arm 12. Figure 4 The support 143a on the left side extends, and... Figure 4 The wire 4 is threaded back and forth multiple times through the wire hole 145 of the support 143a on the left side to form a multi-turn structure for binding and / or knotting. Afterwards, the binding wire 4 passes through the wire slots 144 on the two supports 143a and 143b again to form a suspended wire segment along the wire path 141 corresponding to the wire cut 142. Figure 4 The cable tray 41 in the lower right corner extends to... Figure 4 The upper right arm 12.

[0202] Binding line 4 along Figure 4 One of the line-blocking components 43 on the top surface 123 of the upper right arm 12 extends to Figure 4 One of the threading holes 121 on the upper right side is then sewn to the location of the artificial heart valve 2, and then threaded back through the other threading hole 121 of the arm 12. Figure 4 The top surface 123 of the upper right arm 12 is tied to the knot hole 122 of the arm, thus completing the threading path of the binding wire 4.

[0203] Reference Appendix Figure 6a To be continued Figure 6cThe application further discloses a control handle joint 3 used for detachably connecting with the valve holder 1, the control handle joint 3 comprises:

[0204] a plug-in part 31 used for detachably plugging in with the valve holder 1, and the plug-in part 31 has a plugged state and a separated state with the valve holder 1;

[0205] a limiting part 32 connected with the plug-in part 31 and used for limiting the valve holder 1 in the plugged state, and a connecting part 312 between the limiting part 32 and the plug-in part 31 is a deformable structure to release the limitation on the valve holder 1;

[0206] a control part 33 connected with at least one of the limiting part 32 and the plug-in part 31, and a friction surface 331 for increasing friction and operation feeling is further arranged on the control part 33.

[0207] During the operation, the control handle joint 3 allows the artificial heart valve 2 to be properly placed and is configured to realize the connection with the valve holder 1 through the plug-in part 31, so that the medical staff can control the valve holder 1 and the artificial heart valve 2 installed on the valve holder 1 through the control handle joint 3, and the working state of the control handle joint 3 and the valve holder 1 can be switched through the limiting part 32.

[0208] When the artificial heart valve 2 is in place, the medical staff can easily remove the control handle joint 3 from the valve holder 1 while maintaining the assembly relationship between the valve holder 1 and the artificial heart valve 2. In contrast, the control handle joint available on the market is connected to the threaded interface of the valve holder, and needs to be bent during the surgical operation, so that the control handle joint cannot be separated from the valve holder by rotation after the artificial heart valve is in place. Therefore, the existing control handle joint can only be removed by detaching the valve holder from the artificial heart valve, especially by cutting a plurality of binding lines on the valve holder. After the valve holder is detached from the artificial heart valve, the valve holder no longer provides protection for the artificial heart valve during subsequent suturing or other operations.

[0209] In the embodiment, the control handle joint 3 can be easily connected and removed without affecting the connection between the valve holder 1 and the artificial heart valve 2, so as to realize the protection of the valve holder 1 on the artificial heart valve 2. In particular, the valve holder 1 can apply an inward force to the artificial heart valve 2 along the connection seat 11 to drive the parts of the artificial heart valve 2 to move towards each other, which can avoid the interference and / or deformation of the artificial heart valve 2 itself on the suturing process.

[0210] In the embodiment, the deformable structure of the control handle joint 3 adopts an elastic material. In other embodiments, the deformable structure of the control handle can be a resettable hinge mechanism.

[0211] In this embodiment, the insertion portion 31 is a rod-shaped, one end of which is an insertion end 311 matched with the holder 1, and the other end of which is adjacent to a connecting portion 312 connected with the limiting portion 32. An adapting hole 3121 is defined on the insertion portion 31 and is a blind hole formed on the insertion portion 31, which is used to install an auxiliary accessory to control the handle joint 3. For example, the auxiliary accessory can be a rod member inserted and axially extended along the insertion portion 31 to realize the relative movement between the insertion portion 31 and the limiting portion 32. The rod member can be the ductile connecting shaft 342 as described below, which can be bonded or inserted and molded in the insertion portion 31.

[0212] Further, the insertion end 311 is a round head structure. The insertion portion 31 is provided with an outward protruding blocking portion 313, which abuts against the holder 1 in the insertion state to limit the axial position of the handle joint 3 relative to the holder 1. The blocking portion 313 extends around the outer periphery of the insertion portion 31.

[0213] The limiting portion 32 has one end of a connecting end 321 connected with the insertion portion 31, and the other end of a limiting end 322 matched with the holder 1. Further, the limiting end 322 is hook-shaped, which is matched with the clamping portion 16 on the connecting seat 11 as described above, as shown in Figure 8c and Figure 8d .

[0214] The insertion end 311 extends axially beyond the limiting end 322 by 2% to 30%. The control portion 33 is fixedly connected with the limiting portion 32. The control portion 33 and the limiting portion 32 are both rod-shaped and have the same extension direction. The limiting portion 32 and the insertion portion 31 are arranged in parallel. The insertion portion 31, the limiting portion 32 and the control portion 33 are an integral structure.

[0215] Figures 1a to 8d A delivery assembly for a prosthetic heart valve 2 is shown, which includes the holder 1 and the handle joint 3 as described above. The holder 1 and the handle joint 3 are detachably connected.

[0216] Figure 9a and 9b In addition, the prosthetic heart valve 2 and the holder 1 are shown, which are positioned against each other and connected with each other by the binding wire 4, and the handle joint 3, which is detachably connected with the holder 1.

[0217] Figure 10aA control handle is also shown, which comprises a handle 341, a connecting shaft 342 with ductility, and the control handle joint 3 described above, one end of the connecting shaft 342 is connected with the handle 341, and the other end of the connecting shaft 342 is connected with the control handle joint 3. The connecting shaft 342 can be made of metal or plastic or other materials with certain rigidity. Preferably, the connecting shaft 342 is bonded to the handle 341 and inserted into the matching hole 3121 provided on the control handle joint 3.

[0218] Finally, the control handle is connected with the valve 1 by inserting the plug end 311 of the control handle joint 3 into the plug hole 15 of the valve 1.

[0219] As shown in the figure, the operator can simply position the holder 1 and the artificial heart valve 2 through the handle 341. Figure 10b

[0220] The present application can be implemented in the following manner:

[0221] First, the artificial heart valve 2 is connected to the holder 1 by abutting the outflow side 92 of the artificial heart valve 2 with the holder 1; then the artificial heart valve 2 and the holder 1 are fixedly bound by the binding wire 4 using the above-described suturing technique. Alternatively, the artificial heart valve 2 and the holder 1 fixedly bound by the binding wire 4 are accommodated in a package. Further, in the package, the holder 1 faces the opening part of the package for cooperation with a preset component to facilitate the removal of the artificial heart valve 2 and the holder 1. As an example, the preset component is the control handle joint 3.

[0222] In the next step, the control handle joint 3 is engaged with the holder 1 by the above-described technique. Once the patient's native leaflet is removed and the annular suture is placed, the suture is sewn through the sewing ring 21 of the artificial heart valve 2.

[0223] Next, the combined artificial heart valve 2, holder 1 and control handle joint 3 "airdrop" to the annular suture, through the patient's open chest cavity to the patient's annulus, the artificial heart valve 2 will be implanted in the annulus.

[0224] Generally, the artificial heart valve is taken as an example of the aortic artificial valve, and its direction is opposite to the blood flow direction. If it is a mitral artificial valve, the orientation direction can be in the direction of blood flow.

[0225] Once the doctor determines that the artificial heart valve 2 is in the correct position, the holder 1 and the control handle joint 3 are disconnected and separated from the artificial heart valve 2 to release the artificial heart valve 2.

[0226] ​The disconnection and detachment of the prosthetic heart valve 2 is achieved by cutting the binding thread 4 at the thread cutting port 142 to release the binding thread 4, thereby disconnecting and detaching the valve holder 1 together with the binding suture thread 4 from the prosthetic heart valve 2.

[0227] Alternatively, the surgeon can choose to keep the valve holder 1 connected to the prosthetic heart valve 2 while tying the ring knot. By depressing the control 33 to disengage the detent end 322 from the catch 16, the handle 341 is withdrawn to release the control handle joint 3 from the valve holder 1. Keeping the valve holder 1 connected to the prosthetic heart valve 2 during knot tying will allow better access to the suture ring 21 adjacent the junction. After the knot is completed, the valve holder can be removed by cutting the binding thread 4 at the thread cutting port 142 and pulling the valve holder 1 up from the prosthetic heart valve 2 using surgical instruments. This alternative method takes advantage of the inward deflection of the junction by allowing better access to the suture ring 21.

[0228] The technical features of the above embodiments can be combined in any manner. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described, however, as long as the combinations of the technical features do not contradict each other, they shall be considered within the scope of the present disclosure. When technical features in different embodiments are embodied in the same figure, it can be considered that the figure also discloses the combination of the embodiments involved.

[0229] The above embodiments only express several implementation manners of the present application, and the description is specific and detailed, but it should not be understood as a limitation on the patent application scope. It should be noted that for those skilled in the art, without departing from the concept of the present application, several modifications and improvements can be made, which are within the scope of the present application.

Claims

1. A holder for delivering a prosthetic heart valve, characterized in that Comprising a connecting seat having an axial direction, one end of the axial direction of the connecting seat being a distal end facing the artificial heart valve, the other end being a proximal end facing away from the artificial heart valve; and a first holding arm, a second holding arm and a third holding arm distributed on the outer periphery of the connecting seat, a wire channel for threading the binding wire being provided between two adjacent holding arms, each holding arm having a positioning structure at its distal end for cooperating with the outflow side of the artificial heart valve, the positioning structure being a clamping groove, each clamping groove having a wall, and the wall of the clamping groove provides a fastening force to the artificial heart valve in the radial inward direction of the connecting seat to achieve a radial inward deflection of the engagement tip of the artificial heart valve and the positioning structure by 0.5-5mm; at least one holding arm is provided with a frame for disposing the binding wire for binding the artificial heart valve, the ends of the binding wire are fixed to the valve holder, the extension path of the binding wire is single and passes through a cutting port so that a single cutting operation at the cutting port releases the binding wire; the binding wire is wound as follows: one end of the binding wire is wound and fixed on the knot hole on the first holding arm, each of the holding arms is also provided with at least one threading hole for threading the binding wire for binding the artificial heart valve, the binding wire enters one of the threading holes along the top surface of the first holding arm, then is sewn and connected with the part of the artificial heart valve located here, and then passes through another threading hole of the first holding arm to return to the top surface of the first holding arm; the binding wire continues to enter the frame on the second holding arm along one of the wire blocking pieces and the wire channel along the top surface of the first holding arm, the frame has a wire passing path and a cutting port corresponding to the wire passing path, the wire passing path allows the wire segment of the binding wire extending along the wire passing path to be suspended, the frame at least includes a pair of oppositely arranged supporting seats, the gap between the pair of supporting seats serves as the cutting port, each supporting seat is provided with a wire clamping groove for threading the binding wire, and the wire passing path is between the two wire clamping grooves; the binding wire successively passes through the wire clamping grooves on the two supporting seats and forms a suspended wire segment along the wire passing path corresponding to the cutting port; the binding wire continues to extend to the other supporting seat along the top surface of the second holding arm through the wire passing hole on one of the supporting seats and into the cutting port, and then extends along the top surface of the second holding arm until entering the threading hole on the second holding arm and being sewn and connected with the part of the artificial heart valve located here, and then passes through another threading hole of the second holding arm to return to the top surface of the second holding arm; the binding wire continues to extend to the other supporting seat along the top surface of the second holding arm, and the wire passing hole of the other supporting seat is threaded back and forth for multiple turns to form a binding and / or knotting multi-turn structure, after that, the binding wire again passes through the wire clamping grooves on the two supporting seats to form a suspended wire segment along the wire passing path corresponding to the cutting port again; The binding wire continues to extend to the third holding arm through another wire slot, and then extends to a threading hole in the third holding arm through one of the wire blocking parts on the top surface of the third holding arm, and then is sutured and connected with the part of the artificial heart valve located here, and then is threaded back to the top surface of the third holding arm through another threading hole of the third holding arm, and is bound on the knot hole of the third holding arm, so as to complete the threading path of the binding wire.

2. The holder for delivering a prosthetic heart valve according to claim 1, characterized in that The plurality of holding arms are arranged at intervals along the circumference of the connecting seat.

3. The valve holder for delivering a prosthetic heart valve of claim 1, wherein, The plurality of holding arms are in an integrated structure or a split structure with the connecting seat, and the plurality of holding arms are distributed radially along the circumference of the connecting seat.

4. The valve holder for delivering a prosthetic heart valve of claim 1, wherein, The positioning structure is arranged in a single disc.

5. The valve holder for delivering a prosthetic heart valve of claim 1, wherein, Each clamping groove has an opening, and the openings of all the clamping grooves are directed in the same direction.

6. The valve holder for delivering a prosthetic heart valve of claim 5, wherein, The clamping groove is open in the axial direction of the valve holder, and the slot of the clamping groove is located at the distal end and is directed towards the artificial heart valve.

7. The valve holder for delivering a prosthetic heart valve of claim 1, wherein, The positioning structure is a clamping groove, each clamping groove has an opening, and along the axial direction of the connecting seat, the opening of the frame and the clamping groove is located on the opposite side of each of the at least one holding arm.

8. The valve holder for delivering a prosthetic heart valve of claim 1, wherein, The wire slot has the same direction or opening as the clamping groove.

9. The valve holder for delivering a prosthetic heart valve of claim 1, wherein, The connecting seat has an insertion hole extending in the axial direction.

10. The valve holder for delivering a prosthetic heart valve according to claim 9, characterized in that The connecting seat has a clamping part.

11. The valve holder for delivering a prosthetic heart valve of claim 1, wherein, The at least one holding arm is configured as a single disc, and the positioning structure is arranged at the distal end thereof for cooperating with the outflow side of the artificial heart valve.

12. An assembly for delivering a prosthetic heart valve, comprising a valve holder, and a control handle detachably connected with the valve holder, characterized in that, The valve holder comprises: a connecting seat having an axial direction, one end of the axial direction of the connecting seat being a distal end directed towards the artificial heart valve, and the other end being a proximal end directed away from the artificial heart valve; and a first holding arm, a second holding arm and a third holding arm distributed on the outer periphery of the connecting seat, a wire slot for threading a binding wire being arranged between any two adjacent holding arms, each holding arm having a positioning structure at the distal end thereof for cooperating with the outflow side of the artificial heart valve, the positioning structure being a clamping groove, each clamping groove having a wall, and the wall of the clamping groove provides a fastening force to the artificial heart valve in the direction of the radial inward direction of the connecting seat to achieve a deflection of 0.5-5mm of the engagement tip of the artificial heart valve cooperating with the positioning structure in the radial inward direction; at least one holding arm has a frame for arranging a binding wire for binding the artificial heart valve, the ends of the binding wire are fixed to the valve holder, and the extension path of the binding wire is a single wire and is cut at a wire cutting port to release the binding wire in a single cutting operation; the binding wire is wound as follows: one end of the binding wire is wound and fixed on the knot hole of the first holding arm, and each of the holding arms further has at least one threading hole for threading the binding wire for binding the artificial heart valve, the binding wire enters one of the threading holes along the top surface of the first holding arm, is then sutured and connected with the part of the artificial heart valve located here, and is then threaded back to the top surface of the first holding arm through another threading hole of the first holding arm; The binding thread continues to run along the top surface of the first holding arm along one of the thread blocking members and the thread running groove into the frame on the second holding arm, the frame has a thread running path and a thread cutting opening corresponding to the thread running path, the thread running path allows the thread segment of the binding thread extending along the thread running path to be suspended, the frame at least includes a pair of supporting seats arranged oppositely, the gap between the pair of supporting seats serves as the thread cutting opening, each supporting seat is provided with a thread clamping groove for guiding the binding thread, and the thread running path is between the two thread clamping grooves; the binding thread passes through the thread clamping grooves on the two supporting seats in sequence, and forms a suspended thread segment along the thread running path corresponding to the thread cutting opening; the binding thread continues to run through the thread cutting opening on one of the supporting seats into the thread cutting opening and along the top surface of the second holding arm until entering the thread passing hole on the second holding arm and being sewn and connected with the part of the artificial heart valve located here, and then runs back to the top surface of the second holding arm through the other thread passing hole of the second holding arm; the binding thread continues to run along the top surface of the second holding arm to the other supporting seat, and passes through the thread cutting opening on the other supporting seat back and forth for multiple turns to form a binding and / or knot structure, and then the binding thread passes through the thread clamping grooves on the two supporting seats again to form a suspended thread segment along the thread running path corresponding to the thread cutting opening again; the binding thread continues to run through the other thread running groove and then extends to the third holding arm, the binding thread extends along one of the thread blocking members on the top surface of the third holding arm to a thread passing hole on the third holding arm, and then is sewn and connected with the part of the artificial heart valve located here, and then runs back to the top surface of the third holding arm through the other thread passing hole of the third holding arm and is bound on the knot hole of the third holding arm, to complete the threading path of the binding thread; and wherein the control handle comprises: a plug-in part for detachably plugging with the valve holder, and the plug-in part and the valve holder have a plugged state and a separated state; a limiting part connected with the plug-in part for limiting the valve holder in the plugged state, and the connecting part between the limiting part and the plug-in part is a deformable structure to release the limitation on the valve holder; and a control part connected with at least one of the limiting part and the plug-in part.

13. The assembly of claim 12, wherein, The deformable structure is a resettable hinge mechanism or uses an elastic material.

14. The assembly of claim 12, wherein, The plug-in part is provided with an outwardly convex blocking part, and in the plugged state, the blocking part abuts against the valve holder to limit.

15. The assembly of claim 12, wherein, One end of the limiting part is a connecting end connected with the plug-in part, and the other end is a limiting end matched with the valve holder; the limiting end is hook-shaped.

16. A prosthetic heart valve loading system, comprising: It comprises: an artificial heart valve having an outflow side and a plurality of joint parts, and a valve holder, wherein the valve holder comprises: a connecting seat having an axial direction, wherein one end of the connecting seat in the axial direction is a distal end facing the artificial heart valve, and the other end is a proximal end facing away from the artificial heart valve; and ​ The first, second and third holding arms are distributed around the outer periphery of the connecting seat, and a wire slot for threading the binding wire is arranged between two adjacent holding arms. Each holding arm has a positioning structure at its distal end for cooperating with the outflow side of the artificial heart valve. The positioning structure is a clamping groove, each clamping groove has a wall, and the wall of the clamping groove provides a fastening force to the artificial heart valve in the radial inward direction of the connecting seat to deflect the engagement tip of the artificial heart valve by 0.5-5mm radially inward; at least one holding arm is provided with a frame for disposing the binding wire for binding the artificial heart valve, the ends of the binding wire are fixed to the valve holder, and the extension path of the binding wire is a single path and passes through a cutting port so that a single cutting operation at the cutting port releases the binding wire; the binding wire is wound as follows: One end of the binding wire is wound and fixed on the knot hole on the first holding arm, and each holding arm is further provided with at least one threading hole for threading the binding wire for binding the artificial heart valve. The binding wire enters one of the threading holes along the top surface of the first holding arm, is then sewn and connected to the part of the artificial heart valve located there, and then passes through another threading hole of the first holding arm to return to the top surface of the first holding arm. The binding wire continues to extend along the top surface of the first holding arm along one of the wire blocking members and the wire slot to the frame on the second holding arm. The frame has a wire passing path and a cutting port corresponding to the wire passing path. The wire passing path allows the wire segment of the binding wire extending along the wire passing path to be suspended. The frame includes at least a pair of supporting seats arranged oppositely, and the gap between the pair of supporting seats serves as the cutting port. Each supporting seat is provided with a wire clamping groove for threading the binding wire, and the wire clamping grooves between the two supporting seats form the wire passing path. The binding wire successively passes through the wire clamping grooves on the two supporting seats and forms a suspended wire segment along the wire passing path corresponding to the cutting port. The binding wire continues to extend to the cutting port through the wire passing hole on one of the supporting seats and along the top surface of the second holding arm until it enters the threading hole on the second holding arm and is sewn and connected to the part of the artificial heart valve located there, and then passes through another threading hole of the second holding arm to return to the top surface of the second holding arm. The binding wire continues to extend along the top surface of the second holding arm to the other supporting seat, and the wire passing hole of the other supporting seat is threaded back and forth to form a multi-turn structure of binding and / or knotting, and thereafter, the binding wire again passes through the wire clamping grooves on the two supporting seats to form a suspended wire segment along the wire passing path corresponding to the cutting port again. The binding wire continues to extend to the third holding arm through another wire slot. The binding wire extends to a threading hole on the third holding arm along one of the wire blocking members on the top surface of the third holding arm, is then sewn and connected to the part of the artificial heart valve located there, and then passes through another threading hole of the third holding arm to return to the top surface of the third holding arm and is bound on the knot hole of the third holding arm, completing the threading path of the binding wire.

17. The prosthetic heart valve loading system of claim 16, wherein, Each of the at least one holding arm has a frame for passing a binding wire of the artificial heart valve, the frame has a wire passing path and a wire cutting port corresponding to the wire passing path, and the wire passing path allows a wire segment of the binding wire extending along the wire passing path to be suspended; all wire segments of the binding wire pass the wire cutting port directly or indirectly.

18. The prosthetic heart valve loading system of claim 16, wherein, The artificial heart valve has an axial direction, one end of the axial direction of the artificial heart valve is provided with a suture ring, and the other end abuts against the valve holder.

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