Control line knob, reflux heart valve conveyor and conveying system

Abstract

The utility model provides a control line knob, a reflux heart valve conveyor and a conveying system, and belongs to the field of medical instruments. The wire control knob comprises a knob body, the knob body comprises a wire control nut, a wire control gasket and a wire control bolt, the knob body is provided with a penetrating through hole for a stay wire to penetrate through, and the penetrating through hole penetrates through the wire control nut, the wire control gasket and the wire control bolt. The wire control gasket is arranged between the wire control bolt and the wire control nut, the wire control nut is in threaded connection with the wire control bolt, and the extrusion force of the wire control gasket on the stay wire is adjusted by controlling the screwing-in distance between the wire control nut and the wire control bolt. The wire control knob is provided with the penetrating through hole, the penetrating through hole is used for containing the stay wire, then the tension degree of the stay wire is controlled by controlling the extrusion force of the wire control gasket located between the wire control nut and the wire control bolt to the stay wire through screwing-in and screwing-out of the wire control nut and the wire control bolt which are in threaded connection, and the pulling speed of the stay wire is controlled in an auxiliary mode through threaded connection; the speed of pulling the stay wire by external force is prevented from being too fast, and operation is convenient.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices for heart valve repair, and in particular to a control line knob, a regurgitant heart valve delivery device and a delivery system. Background Art

[0002] The heart consists of two chambers and two ventricles. The mitral valve, tricuspid valve, aortic valve and pulmonary valve separate the chambers and the heart from the outside. The four valves act as one-way valves, allowing blood in the heart to flow in a predetermined direction but not in the opposite direction.

[0003] The aortic valve connects the left ventricle and the aorta. When the left ventricle expands, the aortic valve is closed, and when the left ventricle contracts, the aortic valve is open. The oxygenated blood in the left ventricle is pumped into the aorta by the systolic pressure, and the oxygenated blood is delivered to all parts of the body through the aorta. Since the systolic pressure is high when the heart contracts, generally reaching 120 mmHg, and even as high as 150 mmHg in patients with hypertension, and the aortic valve is located in a special position, close to the mitral valve ring, for patients with aortic regurgitation, it is necessary to consider the fixation of the regurgitant valve and avoid affecting the normal operation of other valves.

[0004] Traditional aortic valve replacement is a method of establishing extracorporeal circulation by inserting a catheter into the aorta and right atrium through a midline incision in the chest. However, traditional surgical operations cause great damage to patients and take a long time to recover. Especially for elderly patients, it is difficult for them to bear the damage caused by traditional surgical operations. As transcatheter surgery has many advantages such as less trauma and faster recovery, more and more surgeries are being performed through transcatheter surgery. The research on aortic valve replacement has also gradually shifted from early surgical methods to transcatheter aortic valve replacement.

[0005] The reflux stent used in transcatheter aortic replacement is generally inserted into the sinus bottom of the native aortic valve through a positioning piece before the reflux stent is released. After the reflux stent is completely released, the positioning piece and other parts of the reflux stent are used to fix the reflux stent through the native aortic valve and the aortic wall. However, the positioning piece of the existing reflux stent relies on its own elasticity to open a certain angle, or due to incomplete self-release of the positioning piece, in clinical applications, there is a problem that the diameter of the circle where the positioning piece is located is smaller than the diameter of the aortic valve ring, resulting in the problem that the positioning piece is difficult to insert into the sinus bottom.

[0006] In view of the above problems, it is hoped that the positioning member can be controlled by a pull wire, and the opening angle of the positioning member can be adjusted by adjusting the tension of the pull wire. However, the tension control of the pull wire requires fine adjustment and the convenience of operation needs to be considered. Therefore, the present application aims to provide a control wire knob with fine adjustment and easy operation. Utility Model Content

[0007] In view of the problems of the prior art mentioned above, the main purpose of the present application is to provide a wire control knob, a regurgitant heart valve conveyor and a conveying system. Through the structural coordination of the wire control knob, the tightness of the control wire can be controlled more precisely and conveniently. In order to achieve the above purpose and other related purposes, the first aspect of the present application provides a wire control knob, the wire control knob includes a knob body, the knob body includes a wire control nut, a wire control washer and a wire control bolt, and the knob body is provided with a through hole for the pull wire to pass through, the through hole passes through the wire control nut, the wire control washer and the wire control bolt; the wire control washer is arranged between the wire control bolt and the wire control nut, the wire control nut is screwed to the wire control bolt, and the squeezing force of the wire control washer on the pull wire is adjusted by controlling the screwing distance between the wire control nut and the wire control bolt.

[0008] In an implementable embodiment of the first aspect, the wire control knob further includes a wire fixing piece; and the wire fixing piece is detachably connected to the knob body.

[0009] As a preferred solution, the wire fixing member includes a wire fixing portion and a pin column arranged below the wire fixing portion, and the outer diameter of the pin column matches the inner diameter of the through hole.

[0010] In one possible implementation of the first aspect, the wire-control nut includes a threaded sleeve and a pressing sleeve arranged in the threaded sleeve; a stepped hole is provided in the wire-control bolt, and the aperture of the stepped hole is larger than the through hole, and the wire-control washer is arranged in the stepped hole; the threaded sleeve is threadedly connected to the wire-control bolt, and the pressing sleeve presses the upper end of the wire-control washer.

[0011] As a preferred solution, the line-controlling bolt comprises a bolt portion, a stop ring and an insertion portion from top to bottom; the bolt portion is threadedly connected to the threaded sleeve, and the stop ring is used as a threading end point.

[0012] In one possible implementation of the first aspect, the knob body further comprises a wire control sealing ring, the lower end of the wire control sealing ring is connected to the wire control gasket, and the pressing sleeve presses the upper end of the wire control sealing ring. As a preferred solution, the upper part of the wire control gasket is provided with a wire control gasket loading cavity connected to the wire control gasket, and the wire control sealing ring is loaded in the wire control gasket loading cavity; and / or the wire control sealing ring is a hollow boss structure.

[0013] In one possible implementation of the first aspect, the through hole of the wire control nut extends outward to form a cylindrical wire pulling outlet for an external device; and / or the wire control washer includes a middle ring and two end rings located on both sides of the middle ring, and the outer diameter of the middle ring is smaller than the outer diameters of the two end rings; and / or the material of the wire control washer is an elastic material.

[0014] A second aspect of the present application provides a regurgitant heart valve delivery device, comprising a delivery device handle for delivering a regurgitant heart valve, wherein the distal end of the delivery device handle is used to fix the regurgitant heart valve, and the delivery device further comprises the above-mentioned control wire knob and pull wire; the delivery device handle is provided with a pull wire channel leading to the regurgitant heart valve; the control wire knob is provided on the delivery device handle, and the through hole is connected to the pull wire channel, one side end of the pull wire is connected to the heart valve, and the other side end is connected to the control wire knob after passing through the pull wire channel.

[0015] In an implementable embodiment of the second aspect, the pull wire is arranged in the pull wire channel in a folded state.

[0016] In one possible implementation of the second aspect, the conveyor includes a plurality of wire control knobs and a plurality of pull wires, and each of the wire control knobs corresponds to each of the pull wires in a one-to-one manner, and is used to control the regurgitant heart valves respectively.

[0017] The third aspect of the present application provides a regurgitant heart valve delivery system, comprising a regurgitant heart valve and the regurgitant heart valve delivery device described above, wherein the regurgitant heart valve comprises a valve stent and a valve connected to the valve stent, the valve stent comprises a positioning member, and the positioning member is provided with a pull wire composite ring with a pull wire hole; one side end of the pull wire is connected to the pull wire hole of the positioning member, and the other side end passes through the pull wire channel and is connected to the control wire knob.

[0018] In one embodiment of the third aspect, the valve stent includes a plurality of positioning members, the conveyor includes a plurality of control wire knobs and a plurality of pull wires, each of the control wire knobs corresponds to each of the pull wires, one end of each of the pull wires is connected to the control wire knob, and the other end is connected to the pull wire positioning hole of the positioning member.

[0019] In one possible implementation of the third aspect, the material of the pull-wire composite ring is a developing material; and / or the pull-wire composite ring is a regular or irregular geometric shape.

[0020] The control wire knob, regurgitant heart valve delivery device and system provided by the present application have but are not limited to the following beneficial effects:

[0021] 1) The wire control knob of the present application is provided with a through hole, which is used to accommodate the pull wire. Then, the wire control nut and the wire control bolt which are threadedly connected are screwed in and out to control the squeezing force of the wire control washer located between the two on the wire to control the tension of the wire. The threaded connection is used to assist in controlling the pulling speed and the state of the wire, thereby preventing the external force from pulling the wire too fast, and the operation is convenient.

[0022] 2) The wire control knob of the present application also includes a wire fixing member, which is used to further gather and adjust the length (tension) of the positioning wire. In addition, the wire fixing member can also be inserted into the through hole of the knob body to strengthen the fixation of the knob body to the wire.

[0023] 3) The wire control knob of the present application also includes a wire control sealing ring, which cooperates with the wire control gasket to assist in fixing the pull wire and also plays a sealing role. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 Shown is a schematic diagram of the overall structure of the wire control knob according to an embodiment of the present application;

[0025] Figure 2 The exploded view of the line control knob described in Example 1 of the present application at a front view angle is shown;

[0026] Figure 3 The exploded view of the line control knob described in Example 1 of the present application at an oblique angle is shown;

[0027] Figure 4 It shows a schematic diagram of the structure of the line control bolt described in Example 1 of the present application;

[0028] Figure 5 It shows a schematic diagram of the structure of the wire control nut described in Example 1 of the present application;

[0029] Figure 6 Shown is a cross-sectional view of the wire control knob described in Example 1 of the present application;

[0030] Figure 7 It is a schematic diagram showing the structure of the wire fixing member described in Example 1 of the present application;

[0031] Figure 8 Shown is a schematic structural diagram of the regurgitant heart valve delivery device described in Example 2 of the present application;

[0032] Fig. 9 It is a partial cross-sectional view of the regurgitant heart valve delivery device described in Example 2 of the present application;

[0033] Fig.10 Display as Fig. 9 Enlarged view of part A in the middle; Fig.11 Display as Fig.10 Enlarged view of the middle A1 section;

[0034] Fig.12 Shown is a schematic diagram of the structure of the delivery system described in Example 2 of the present application;

[0035] Fig.13 Shown is an enlarged view of the distal end portion of the delivery system described in Example 2 of the present application;

[0036] Fig.14 A schematic diagram showing the structure of a valve stent for a heart valve; Fig.15 Display as Fig.14 Enlarged view of middle part B;

[0037] Figure 16 to Figure 19 Display as Fig.14 The alternative components shown in section B are Fig.16 The main body of the wire-drawing composite ring is triangular; Fig.17 The main body of the wire-drawing composite ring is prismatic; Fig.18 The main body of the wire-drawing composite ring is circular; Fig.19 The main body of the pull wire composite ring is a five-pointed star shape.

[0038] Description of Reference Numerals

[0039] 6 Conveyor handle

[0040] 501 Pull Wire Channel

[0041] 60 Cable control knob

[0042] 601 Line Control Bolt

[0043] 602 Cable washer

[0044] 603 Control line sealing ring

[0045] 604 Wire Control Nut

[0046] 605 Tubular Wire Export

[0047] 606 Stepped Hole

[0048] 607 Compression sleeve

[0049] 608 threaded sleeve

[0050] 609 Cut-off ring

[0051] 70 Cable fixing

[0052] 701 Cable fixing part

[0053] 702 Pin Column

[0054] 90 Pull Wire

[0055] 10 Valve stent

[0056] 13 Fasteners

[0057] 14 Connectors

[0058] 20 Positioning piece

[0059] 2001 Cable Compound Ring DETAILED DESCRIPTION

[0060] As described in the background art, the present application provides a wire control knob for finely adjusting the tightness of a pull wire and convenient operation, as well as a positioning conveyor and a conveying system for a regurgitant heart valve using the wire control knob.

[0061] Explanation of terms in this application: "distal end" and "proximal end" are directional words, which are commonly used terms in the field of interventional medical devices, where "distal end" refers to the end of the delivery system away from the operator during surgery, and "proximal end" refers to the end of the delivery system close to the operator during surgery. "Axial" refers to the direction parallel to the line connecting the distal center and the proximal center of the delivery device; "radial" refers to the direction perpendicular to the above "axial". "Connecting end" in this application generally refers to the connection between one component and another component, and "free end" in this application generally refers to an end of a component that is in a free state and is not connected to other components. "Distal end" refers to the end of the delivery system away from the apex during surgery, and "proximal end" refers to the end of the delivery system close to the apex during surgery. In addition, the regurgitant heart valve includes a valve stent and a valve (artificial valve or biological valve) connected to the valve stent. The regurgitant heart valve, valve body and heart valve described in the embodiments of this application have the same meaning. In addition, the orientations or positional relationships indicated by "upper end", "lower end", "upper part" and "lower part" are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention. In addition, the well-known technologies generally associated with heart valve repair are not described in detail, and those skilled in the art who are not described can understand them according to the conventional methods in the prior art. The following specific embodiments illustrate the implementation of the present application, and those familiar with this technology can easily understand other advantages and functions of the present application from the contents disclosed in this specification.

[0062] Please see attached Figure 1-19 It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings in this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the restrictive conditions for the implementation of this application. Therefore, they have no substantive technical significance. Any modification of the structure, change in the proportion relationship or adjustment of the size should still fall within the scope of the technical content disclosed in this application without affecting the effects and purposes that can be achieved by this application.

[0063] Example 1

[0064] See also Figure 1 to Figure 7The present embodiment provides a wire control knob, which includes a knob body 60, which includes a wire control nut 604, a wire control washer 602 and a wire control bolt 601, and the knob body 60 is provided with a through hole for the wire to pass through, and the through hole passes through the wire control nut 604, the wire control washer 602 and the wire control bolt 601. The wire control washer 602 is arranged between the wire control bolt and the wire control nut 604, and the wire control nut 604 is screwed with the wire control bolt 601, and the squeezing force of the wire control washer 602 on the wire 90 is adjusted by controlling the screwing distance between the wire control nut 604 and the wire control bolt 601. Specifically, the wire control knob is provided with a through hole which passes through the wire control nut 604, the wire control washer 602 and the wire control bolt 601 for allowing the pulling wire to pass through, and the wire control knob controls the squeezing force of the wire control washer located between the threadedly connected wire control nut 604 and the wire control bolt 601 to control the tension of the pulling wire, and the threaded connection is used to assist in controlling the pulling speed and the state of the pulling wire, thereby preventing the external force from pulling the pulling wire too fast, and the operation is convenient.

[0065] In a preferred embodiment, see Figure 7 The wire control knob also includes a wire fixing part 70, which is detachably connected to the knob body 60. The function of the wire fixing part 70 is to further gather and adjust the length tension of the wire. In addition, the wire fixing part 70 can also be inserted into the through hole of the knob body 60 to strengthen the fixation of the knob body 60 to the wire.

[0066] In one specific embodiment, see Figure 6 and 7 The wire fixing member 70 includes a wire fixing portion 701 and a pin column 702 disposed below the wire fixing portion, and the outer diameter of the pin column 702 matches the inner diameter of the through hole. That is, the wire fixing member is a rod, and the upper part of the rod is provided with two cross bars and a part of the rod located between the two cross bars constitutes the wire fixing portion 701. The excess wire passing through the wire control knob 60 is wrapped around the wire fixing member 701, and a pin column 702 is formed at the lower part of the rod. The pin column 702 can be inserted into the through hole of the knob body 60 and is tightly connected with the through hole to better strengthen the fixation of the knob body 60 to the wire. For example, if the pulling force required in the operation is large, the knob body 60 cannot fix the wire alone, and the pin column 702 of the wire fixing member can be partially inserted into the through hole of the knob body 60 to strengthen the fixation of the wire.

[0067] In summary, the knob body 60 is used to adjust the length of the pull wire and fix the pull wire 90 , and the pull wire fixing member 70 is used to further gather and adjust the length of the pull wire and further fix the excess pull wire led out from the knob body 60 .

[0068] In a preferred embodiment, see Figure 3 to Figure 6, the line control nut 604 includes a threaded sleeve 608 and a pressing sleeve 607 arranged in the threaded sleeve 608. A stepped hole 606 is arranged in the line control bolt 601, and the aperture of the stepped hole 606 is larger than the through hole, and the line control washer 602 is arranged in the stepped hole 606. The threaded sleeve 608 is screwed to the line control bolt 601, and the pressing sleeve 607 presses the upper end of the line control washer 602. Specifically, the line control nut 604 is a double sleeve structure that is mutually sleeved, including a pressing sleeve 607 and a threaded sleeve 608. The line control bolt 601 is a hollow structure, and a stepped hole 606 is arranged inside. More specifically, the line control bolt 601 includes a bolt portion, a stop ring 609 and an insertion portion from top to bottom, the bolt portion is screwed to the threaded sleeve 608, and the stop ring 609 is used as the end point of the screw connection. That is, the upper periphery of the line-controlling bolt 601 is provided with an external thread, and the threaded sleeve 608 is provided with an internal thread. The line-controlling bolt 601 and the threaded sleeve 608 are connected by external and internal threads. When the line-controlling bolt 601 and the threaded sleeve 608 are connected, the pressing sleeve 607 presses the line-controlling washer 602 toward the stepped hole 602, so that the line-controlling washer 602 tightens the pull wire therein, and controls the tightening force or locking force of the line-controlling washer 602 on the pull wire through the tightening degree of the internal and external threads. The purpose of setting the stop ring 609 is to avoid excessive squeezing of the line-controlling washer when the line-controlling bolt 601 and the threaded sleeve 608 are screwed together, or even damage the line-controlling knob 60. The inner wall of the threaded sleeve 608 is provided with a limiting groove, and the stop ring 609 can abut against the limiting groove to limit the axial movement distance of the line-controlling bolt 601 and the threaded sleeve 608.

[0069] About the preferred setting of the wire control washer:

[0070] A1: The material of the wire control washer 602 is an elastic material with deformation characteristics, such as rubber material. The wire control washer 602 can squeeze the pull wire 90 by controlling the screwing distance between the wire control nut 604 and the wire control bolt 601 .

[0071] A2: The wire control washer 602 is a hollow cylindrical structure, including a middle ring and two end rings located on both sides of the middle ring, and the outer diameter of the middle ring is smaller than the outer diameters of the two end rings. That is, when the wire control washer 602 is squeezed, the middle ring moves radially toward its center to tighten the pull wire 90 located therein.

[0072] In a preferred embodiment, see Figures 3 to 6 The line control knob 60 also includes a line control sealing ring 603 , the lower end of the line control sealing ring 603 is connected to the line control gasket 602 , and the pressing sleeve 607 presses the upper end of the line control sealing ring 603 .

[0073] In a specific embodiment, the upper portion of the wire control washer 602 is provided with a wire control washer loading cavity connected to the wire control washer 602, and the wire control sealing ring 603 is loaded in the wire control washer loading cavity. The wire control sealing ring 603 is a hollow boss structure. Specifically, the wire control sealing ring 603 is located inside the wire control washer 602 and faces the side of the wire control nut 604. The wire control sealing ring 603 is a hollow inverted boss structure, which plays a role in assisting in fixing the pull wire and sealing. Specifically, the upper portion of the wire control sealing ring 603 is flush with the upper portion of the wire control washer 602, and the lower portion of the wire control washer 602 abuts against the stepped hole 606.

[0074] In a preferred embodiment, see Figure 3 The through hole of the control wire nut 604 extends outward to form a cylindrical wire outlet 605 for external connection. For example, when the control wire knob is used for the reverse flow heart valve delivery device, the cylindrical wire outlet 605 is used to connect an external syringe, and use saline or the like to replace the air in the sheath tube to empty the sheath tube. One component integrates multiple functions, which significantly reduces the number of delivery device components and makes the operation simpler.

[0075] Example 2

[0076] See also Figure 8 to Figure 11 This example provides a regurgitant heart valve delivery device, including a delivery device handle 6 for delivering a regurgitant heart valve, wherein the distal end of the delivery device handle is used to fix the regurgitant heart valve. The delivery device also includes the control wire knob and the pull wire 90 of Example 1. Fig.11 The conveyor handle is provided with a wire pulling channel 501 leading to the regurgitant heart valve. The wire control knob is provided on the conveyor handle 6 and is connected to the wire pulling channel 501 through a through hole. One end of the wire 90 is connected to the heart valve, and the other end passes through the wire pulling channel 501 and is connected to the wire control knob.

[0077] In a specific embodiment, the knob body 60 of the wire control knob is fixedly connected to the housing of the conveyor handle, and the through hole of the knob body 60 is connected to the wire pulling channel 501 provided in the conveyor handle 6, and the wire 90 can be connected to the heart valve after passing through the wire pulling channel 501. The wire pulling positioning member 70 of the wire control knob is detachably connected to the housing of the conveyor handle, such as plugging, and the detachable connection method facilitates the removal of the wire pulling positioning member 70 and the connection with the knob body 60. In addition, the position where the wire pulling positioning member 70 is detachably connected to the housing of the conveyor handle 6 is close to the setting position of the knob body 60, which is convenient for use.

[0078] In a specific embodiment, the pull wire 90 is arranged in a folded state in the pull wire channel 501. Specifically, after one end of the pull wire 90 is connected to the knob body 60, it passes through the pull wire channel 501 in sequence, is connected to the heart valve, and then passes through the pull wire channel 501 in sequence and is connected to the knob body 60. The pull wire 90 arranged in a folded state as above still passes through the same pull wire channel 501 after being folded. In this case, if the pull wire is a relatively thin ordinary pull wire, the pull wire 90 is easy to be entangled with each other in the pull wire channel 501, and it is not easy to pull it out, or it is not easy to adjust the opening angle of the positioning member 20 through the pull wire 90.

[0079] Therefore, in a preferred embodiment, the conveyor handle has several groups of wire pulling channels 501, each group of wire pulling channels 501 includes a wire removal channel and a wire return channel, the wire pulling wire 90 includes a wire removal wire and a return wire connected in one piece, and are respectively arranged in the wire removal channel and the wire return channel, the connection between the wire removal wire and the return wire is connected to the heart valve, specifically the connection hole on the heart valve positioning member, and the free ends of the wire removal wire and the return wire are connected to the knob body 60, that is, the number of wire pulling channels 501 is twice the number of positioning members, that is, each wire pulling wire 90 is in a folded state, occupying two wire pulling channels 501. For another example, the wire pulling wire 90 is a wire pulling wire that forms a closed loop, and after the adjustment is completed, it is cut from the proximal end of the wire pulling wire 90 and withdrawn from the body.

[0080] In addition, the conveyor includes a plurality of control wire knobs and a plurality of pull wires 90, each control wire knob corresponds to each pull wire 90, and is used to control the regurgitant heart valve respectively. For example, the regurgitant heart valve generally has three positioning members, that is, the conveyor has three pull wires and three control wire knobs correspondingly, and the three control wire knobs control the three positioning members respectively by controlling the three pull wires respectively.

[0081] In one specific embodiment, see Fig.10 The symmetry axis direction of the knob body 60 is perpendicular to the central axis direction of the conveyor, which is convenient for users to operate.

[0082] Example 3

[0083] See also Figures 12 to 19 This example provides a regurgitant heart valve delivery system, including a regurgitant heart valve and a regurgitant heart valve delivery device of Example 2, the regurgitant heart valve includes a valve stent 10 and a valve connected to the valve stent, the valve stent 10 includes a positioning member 20, the positioning member 20 is provided with a pull wire composite ring 2001 with a pull wire hole; one side end of the pull wire 90 is connected to the pull wire hole of the positioning member 20, and the other side end passes through the pull wire channel 501 and is connected to the control wire knob.

[0084] In a preferred embodiment, the valve stent 10 includes a plurality of positioning members 20, and the conveyor includes a plurality of control wire knobs and a plurality of pull wires 90, each control wire knob corresponds to each pull wire 90, one end of each pull wire 90 is connected to the control wire knob, and the other end is connected to the pull wire positioning hole of the positioning member 20. For example, a regurgitant heart valve generally has three positioning members, that is, the conveyor has three pull wires and three control wire knobs, and the three control wire knobs control the three positioning members respectively by controlling the three pull wires respectively.

[0085] See also Fig.14 , showing a stereoscopic view of the heart valve in an extended state. The heart valve of this embodiment only shows the stent, and the valve and the covering are not shown. The stent may include the distal end of the heart valve stent close to the apex when the heart valve stent is in an extended state, and the proximal end of the heart valve stent away from the apex when the heart valve stent is in an extended state. The proximal end of the heart valve stent may include a connector 14 and a positioning member 20 and a fastener 13 arranged between adjacent connectors. The positioning member 12 can be used to position the heart valve, and the fastener 13 can be used to fix the artificial heart valve leaflets. After the heart valve stent is placed in the aortic valve position, the positioning member 20 will clamp the native leaflets with the fastener 13, and the artificial heart valve fixed inside the heart valve stent will replace the native leaflets to work.

[0086] Specifically, the distal end of the positioning member 20 is a parabolic structure, which reduces the contact stress between the positioning member 20 and the sinus bottom and prevents the valve ring from rupturing. The width of the fastener 13 is wider than the width of the positioning member 20 to provide strong support.

[0087] More specifically, the free end of the positioning member 20 is provided with a wire drawing composite ring 2001, and the wire drawing hole is arranged on the wire drawing composite ring 2001. Preferably, the material of the wire drawing composite ring 2001 is a developing material. Specifically, the far end of the traditional positioning member is provided with a mark "marker" (the mark is non-radiopaque). Although the setting of the "marker" facilitates the positioning implantation of the stent to a certain extent, there is a risk of the "marker" falling off. If the "marker" falls off and enters other organs with the blood flow, this will seriously affect the safety of the user. The wire drawing composite ring 2001 of this embodiment cancels the "marker" installation hole, but the wire drawing composite ring 2001 itself is arranged to have a developing function, which increases the safety of the user. An X-ray-proof marking layer can be arranged on the surface of the connecting plate of the wire drawing composite ring 2001, or a high-density metal plating layer can be added on the surface of the connecting plate, so that the wire drawing composite ring 2001 can be clearer under X-rays.

[0088] Preferably, the pull wire compound ring 2001 is a regular or irregular geometric shape, that is, the outer contour of the connecting plate of the pull wire compound ring 2001 can be set to one or more of a gourd shape, a triangle, a circle, a diamond shape or a cat's paw shape. The pull wire compound ring 2001 has a specific shape, which is convenient for operators to quickly identify the pull wire compound ring 2001, thereby replacing the mark "marker".

[0089] In a specific embodiment, the connecting plate of the pull wire composite ring 2001 includes a fixed end and a free end, the fixed end of the connecting plate is fixedly connected to the heart valve stent, and the free end of the connecting plate is inclined inward along the axis of the heart valve stent. The pull wire hole can be set at the free end of the connecting plate. The positioning pull wire 90 can pass through the pull wire hole, improve the operation of the positioning member 20, and can realize the opening and closing control and positioning of the positioning member 20, and the positioning member 20 can also help reduce the difficulty of surgical operation through the opening angle. Because the pull wire hole is convenient for inserting the positioning pull wire 90, during the implantation process, by adjusting the relative position of the positioning pull wire 90 connected to the control line knob 60, the opening angle of the stent distal end positioning member 20 is controlled to adapt to the size of the native leaflet of different patients, facilitate the insertion of the sinus bottom of the native leaflet, prepare for the subsequent capture of the native leaflet, and reduce the difficulty of the positioning member inserting the sinus bottom. In a preferred embodiment, the pull wire composite ring 2001 is arranged on the inner side of the distal end of the positioning member 20, and is inclined inward relative to the axis of the stent. In other words, the connecting plate of the wire composite ring 2001 is fixedly connected to the distal end of the positioning member 20, and can even be integrally formed. Because the wire composite ring 2001 is tilted inward relative to the axis of the self-expanding heart valve stent, it can prevent the proximal end of the wire composite ring from colliding with the aortic wall during the shaking of the stent, thereby damaging the aorta, which may seriously cause aortic dissection in the user and threaten the user's life.

[0090] The method of using the above-mentioned control line knob is briefly described in conjunction with the delivery system: 1) compress and load the regurgitant heart valve to the distal end of the delivery device and use corresponding components to perform ballasting and fixation; 2) use the delivery device handle to deliver the heart valve to the aortic valve and adjust it into position so that the positioning member enters the sinus, and at this time the control line knob and the pull line remain locked; 3) if the positioning member fails to enter the sinus, the control line bolt and the control line nut of the control line knob can be used again to exert an extrusion force on the control line washer to adjust the tightness of the pull line, for example, 1) first loosen the extrusion of the control line washer on the pull line, pull the pull line so that the free end of the positioning member 20 opens to a height higher than the edge of the native leaflet, that is, through the adjustment of the pull line, the positioning member 20 recaptures the native leaflet without the valve retreating; for example, 2) directly continue to tighten the control line bolt and the control line nut to increase the extrusion force of the two on the control line washer, and assist in controlling the pulling speed and state of the pull line through a threaded connection to avoid the speed of the pull line being pulled too fast by external force, and the operation is convenient.

[0091] The above description of the embodiments is to facilitate those of ordinary skill in the art to understand and apply the present application. It is obvious that those familiar with the art can easily make various modifications to these embodiments and apply the general principles described herein to other embodiments without having to pay creative labor. Therefore, the present application is not limited to the embodiments herein, and improvements and modifications made by those skilled in the art based on the contents disclosed in the present application without departing from the scope and spirit of the present application are within the scope of the present application.

Claims

1. A line control knob, comprising a knob body (60), characterized in that: The knob body (60) comprises a wire control nut (604), a wire control washer (602) and a wire control bolt (601), and the knob body (60) is provided with a through hole for allowing the pull wire to pass through, and the through hole passes through the wire control nut (604), the wire control washer (602) and the wire control bolt (601); The wire-control washer (602) is arranged between the wire-control bolt and the wire-control nut (604), and the wire-control nut (604) is threadedly connected to the wire-control bolt (601). The squeezing force of the wire-control washer (602) on the pull wire (90) is adjusted by controlling the screwing distance between the wire-control nut (604) and the wire-control bolt (601).

2. The line control knob according to claim 1, characterized in that: The wire control knob further comprises a wire fixing member (70); the wire fixing member (70) is detachably connected to the knob body (60); And / or, the wire control nut (604) comprises a threaded sleeve (608) and a pressing sleeve (607) disposed in the threaded sleeve (608); a stepped hole (606) is disposed in the wire control bolt (601), and the diameter of the stepped hole (606) is larger than that of the through hole, and the wire control washer (602) is disposed in the stepped hole (606); The threaded sleeve (608) is threadedly connected to the line-controlling bolt (601), and the pressing sleeve (607) presses against the upper end of the line-controlling washer (602).

3. The line control knob according to claim 2, characterized in that: The wire fixing member (70) comprises a wire fixing portion (701) and a pin column (702) arranged below the wire fixing portion, and the outer diameter of the pin column (702) matches the inner diameter of the through hole; And / or, the line control bolt (601) includes a bolt portion, a stop ring (609) and an insertion portion from top to bottom; the bolt portion is threadedly connected to the threaded sleeve (608), and the stop ring (609) is used as a threading end point.

4. The wire control knob according to claim 2 or 3, characterized in that: The knob body (60) further comprises a wire control sealing ring (603), the lower end of the wire control sealing ring (603) is connected to the wire control gasket (602), and the pressing sleeve (607) presses the upper end of the wire control sealing ring (603).

5. The wire control knob according to claim 4, characterized in that: The upper part of the wire control washer (602) is provided with a wire control washer loading cavity which is connected to the wire control washer (602), and the wire control sealing ring (603) is loaded in the wire control washer loading cavity; and / or the wire control sealing ring (603) is a hollow boss structure.

6. The wire control knob according to any one of claims 1 to 3 or 5, characterized in that: The through hole of the wire control nut (604) extends outward to form a cylindrical wire outlet (605) for connecting to an external device; And / or, the wire control washer (602) includes a middle ring and two end rings located on both sides of the middle ring, and the outer diameter of the middle ring is smaller than the outer diameters of the two end rings; and / or, the material of the wire control washer (602) is elastic material.

7. A regurgitant heart valve delivery device, comprising a delivery device handle (6) for delivering a regurgitant heart valve, wherein the distal end of the delivery device handle is used to fix the regurgitant heart valve, characterized in that: It comprises the control wire knob and the pull wire as claimed in any one of claims 1 to 6; the conveyor handle is provided with a pull wire channel (501) leading to the regurgitant heart valve; The wire control knob is arranged on the conveyor handle (6), and the through hole is connected to the wire pulling channel (501), one end of the wire pulling (90) is connected to the heart valve, and the other end passes through the wire pulling channel (501) and is connected to the wire control knob.

8. The regurgitant heart valve delivery device according to claim 7, characterized in that: The pull wire (90) is arranged in the pull wire channel (501) in a folded state; And / or, the conveyor comprises a plurality of wire control knobs and a plurality of pull wires (90), each of the wire control knobs and each of the pull wires (90) being in one-to-one correspondence, and being used to control the regurgitant heart valves respectively.

9. A regurgitant heart valve delivery system, characterized in that: It comprises a regurgitant heart valve and a regurgitant heart valve delivery device as described in claim 7 or 8, wherein the regurgitant heart valve comprises a valve support (10) and a valve connected to the valve support, the valve support (10) comprises a positioning member (20), and the positioning member (20) is provided with a pull wire composite ring (2001) with a pull wire hole; one side end of the pull wire (90) is connected to the pull wire hole of the positioning member (20), and the other side end passes through the pull wire channel (501) and is connected to the control wire knob.

10. The regurgitant heart valve delivery system according to claim 9, characterized in that: The valve support (10) includes a plurality of positioning members (20), and the conveyor includes a plurality of control wire knobs and a plurality of pull wires (90), each of the control wire knobs and each of the pull wires (90) is in one-to-one correspondence, one end of each of the pull wires (90) is connected to the control wire knob, and the other end is connected to the pull wire positioning hole of the positioning member (20); And / or, the material of the pull-wire composite ring (2001) is a developing material; and / or, the pull-wire composite ring (2001) is a regular or irregular geometric shape.

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