Reverse flow heart valve conveyor capable of achieving simple emptying and reverse flow heart valve conveying system capable of achieving accurate bending adjustment

Abstract

The utility model provides a simplified emptying reflux heart valve conveyor and a precise bending regulation reflux heart valve conveying system, and belongs to the technical field of medical instruments. The conveyor comprises a conveyor handle, and the conveyor handle comprises a handle shell, a valve conveying pipe assembly connected with the handle shell and an outer sheath pipe assembly arranged in the handle shell. A control line knob communicated with the outer sheath tube assembly is arranged on the handle shell, a penetrating through hole is formed in the control line knob and used for being externally connected with an emptier, the outer sheath tube assembly is arranged on an outer sheath tube outside the valve conveying tube assembly in a sleeving mode, and an outer sheath tube fixing piece is fixedly arranged in the handle shell. The outer sheathing canal fixing part comprises an outer sheathing canal inserting hole and an emptying connecting port which penetrate through the outer sheathing canal fixing part, the outer sheathing canal inserting hole is connected with the outer sheathing canal in an inserting mode, and the penetrating through hole is communicated with the emptying connecting port. According to the conveyor, the wire control knob serves as the emptying opening of the outer sheath tube, the emptying opening of the outer sheath tube does not need to be additionally formed, the number of parts of the conveyor is reduced, and the conveyor is convenient to operate.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices for heart valve repair, and in particular to a streamlined and emptied regurgitant heart valve delivery device and a precisely bendable regurgitant heart valve 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] Transcatheter surgery requires a heart valve delivery device, and the movement of the heart valve is mainly controlled by the pipes installed in the heart valve delivery device, and the pipes need to be emptied before entering the body. Generally, there are several emptying ports if there are several pipes. For example, CN114831674A is a delivery device for an atrial shunt, and its pipes include a delivery catheter and a guide catheter, and are provided with a first emptying portion and a second emptying portion for emptying the two pipelines. However, there are many pipes in the heart valve delivery device, generally including at least four catheters. If each catheter is provided with an emptying portion, the use of the delivery device will remain unchanged. In view of the above problems, it is hoped that a streamlined emptying regurgitant heart valve delivery device can be provided for easy use. Utility Model Content

[0006] In view of the above-mentioned problems of the prior art, the main purpose of the present application is to provide a regurgitant heart valve delivery device with simplified emptying, in which the control line knob is externally connected to the emptying device to simplify the number of emptying ports.

[0007] To achieve the above-mentioned purpose and other related purposes, the present application provides a simplified evacuation regurgitant heart valve delivery device in a first aspect, comprising a delivery device handle, wherein the delivery device handle comprises a handle housing, a valve delivery tube assembly connected to the handle housing, and an outer sheath tube assembly disposed in the handle housing; the handle housing is provided with a control line knob connected to the outer sheath tube assembly, and the control line knob is provided with a through hole for externally connecting an evacuator;

[0008] The outer sheath tube assembly is sleeved on the outer sheath tube outside the valve delivery tube assembly and is fixed in the handle shell. The outer sheath tube fixing part includes an outer sheath tube plug-in hole and an emptying connection port that passes through the outer sheath tube fixing part. The outer sheath tube plug-in hole is plugged into the outer sheath tube, and the through hole is connected to the emptying connection port.

[0009] In one possible implementation of the first aspect, the outer sheath is provided with a plurality of pull wire channels, one end of an external pull wire is connected to the heart valve, and the other end passes through the pull wire channel and is connected to the wire control knob.

[0010] In one possible implementation of the first aspect, the wire control knob includes a wire control nut, a wire control washer and a wire control bolt, and the through hole penetrates 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 threadedly connected to the wire control bolt, and the through hole extends outward to form a cylindrical wire pull outlet for externally connecting an emptying syringe.

[0011] As a preferred embodiment, 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.

[0012] As a preferred solution, the wire control knob further includes a wire control sealing ring, which is located inside the wire control washer and faces one side of the wire control nut, and the wire control sealing ring is a hollow inverted boss structure;

[0013] As a preferred solution, the line control washer comprises 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.

[0014] 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 line-controlling nut, and the stop ring is used as a threading end point.

[0015] In an implementable embodiment of the first aspect, the wire control washer is made of elastic material.

[0016] In one possible implementation of the first aspect, the outer sheath tube fixing member further includes a blocking plate and a sealing ring disposed at the proximal end of the outer sheath tube fixing member; and / or, reinforcing ribs are disposed on the outer periphery of the outer sheath tube insertion hole.

[0017] In one possible implementation of the first aspect, the valve delivery tube assembly comprises an inner tube, a middle tube and an outer tube which are sleeved in sequence;

[0018] The valve delivery tube assembly also includes a distal release structure connected to the inner tube, a valve fixing structure connected to the middle tube, and a proximal release structure connected to the outer tube;

[0019] The valve fixing mechanism is provided with an emptying passage, one port of the emptying passage 701 is connected to the inner tube, and the other port is used for an external emptying device; and / or, one port of the emptying passage is connected to the middle tube, and the other port is used for an external emptying device.

[0020] As a preferred solution, a middle-inner tube passage connecting the middle tube and the inner tube is provided between the middle tube and the inner tube;

[0021] And / or, a middle-outer tube passage connecting the middle tube and the outer tube is provided between the middle tube and the outer tube.

[0022] As a preferred embodiment, the distal release structure includes an inner tube connector, and the inner tube is connected to the inner tube connector; preferably, the inner tube connector includes a hollow inner tube plug-in section and a first cylindrical fixing block, the outer circumference of the first cylindrical fixing block matches the inner circumference of the handle shell, and the inner tube is plugged into the inner tube plug-in section; preferably, the distal release structure also includes an inner tube threaded guide provided on the inner tube connector and a distal release knob threadedly connected to the inner tube threaded guide; the handle shell is provided with an inner tube movable guide groove, the inner tube connector is provided in the handle shell, and the inner tube threaded guide can be movably provided in the inner tube movable guide groove; preferably, an inner tube emptying tube is provided at the proximal end of the inner tube connector.

[0023] As a preferred embodiment, the valve fixing structure includes a middle tube connector fixed in the handle shell, the middle tube is connected to the middle tube connector, and the emptying passage passes through the middle tube connector and is connected to the inner tube; preferably, the middle tube connector includes a hollow middle tube plug-in section and a third cylindrical fixing block, the outer circumference of the third cylindrical fixing block matches the inner circumference of the handle shell, and the middle tube is plugged into the middle tube plug-in section.

[0024] As a preferred embodiment, the proximal release structure includes an outer tube connector, and the outer tube is connected to the outer tube connector; preferably, the outer tube connector includes a hollow outer tube plug-in section and a second cylindrical fixing block, the outer circumference of the second cylindrical fixing block matches the inner circumference of the handle shell, and the outer tube is plugged into the outer tube plug-in section; preferably, the proximal release structure also includes an outer tube threaded guide provided on the outer tube connector and a proximal release knob threadedly connected to the outer tube threaded guide; the handle shell is provided with an outer tube movable guide groove, the outer tube connector is provided in the handle shell, and the outer tube threaded guide is movably provided in the outer tube movable guide groove.

[0025] As another preferred solution, the middle inner tube passage is arranged close to the proximal end of the middle tube.

[0026] As another preferred solution, the middle and outer tube passage is arranged close to the proximal end of the outer tube.

[0027] In one possible implementation of the first aspect, the valve delivery tube assembly also includes a reinforcing tube, which is sleeved on the outside of the middle tube, and the distal end of the reinforcing tube is sleeved into the outer tube, and a middle-strong tube passage connecting the reinforcing tube and the middle tube is provided between the reinforcing tube and the middle tube; a middle-inner tube passage connecting the middle tube and the inner tube is provided between the middle tube and the inner tube.

[0028] As a preferred solution, the middle inner tube passage is arranged close to the proximal end of the middle tube; and the middle strong tube passage is arranged close to the proximal end of the reinforced tube.

[0029] A second aspect of the present application provides a precisely bendable regurgitant heart valve delivery system, comprising a regurgitant heart valve and the above-mentioned streamlined evacuation regurgitant heart valve delivery device.

[0030] The simplified evacuation regurgitant heart valve delivery device and system provided by the present application have but are not limited to the following beneficial effects:

[0031] 1) In the present application, the wire control knob is used as the emptying port of the outer sheath tube, and there is no need to open an additional emptying port of the outer sheath tube, thereby saving the number of components of the conveyor and making the conveyor easy to operate.

[0032] 2) The present application provides an emptying passage in the valve fixing mechanism, and the emptying passage can be used to empty the inner tube. In addition, a middle-inner tube passage or a middle-outer tube passage can be optionally opened to realize the emptying of the inner tube and the middle tube, or the inner tube, the middle tube and the outer tube through the emptying passage, thereby further reducing the number of components of the conveyor and making the conveyor easy to operate. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 Shown is a schematic diagram of the structure of the conveyor described in Example 1 of the present application with part of the handle shell cut off.

[0034] Figure 2 Display as Figure 1 Enlarged view of middle E part; Figure 3 Display as Figure 1 Enlarged view of part F in the middle.

[0035] Figure 4 The overall structure diagram of the control line knob is shown; Figure 5 The display is an exploded view of the line control knob from the front view angle; Figure 6 The display is an exploded view of the control line knob at an oblique angle; Figure 7 Shown is a schematic diagram of the structure of the line control bolt; Figure 8 Shown is a schematic diagram of the structure of the wire control nut.

[0036] Fig. 9 Shown is a cross-sectional view of the line control knob described in Example 1 of the present application.

[0037] Fig.10 Shown is a partial longitudinal cross-sectional view of the conveyor described in Example 1 of the present application.

[0038] Fig.11 Display as Fig.10 Enlarged view of part A in .

[0039] Fig.12 Shown is an exploded view of the conveyor; Fig.12a A cross-section of the conveyor tube is shown after sleeve connection.

[0040] Fig.13 Display as Fig.10 The enlarged view of the C part in FIG. Fig.14 Display as Fig.10 Enlarged view of part B in .

[0041] Fig.15 Shown is a schematic diagram of a mid-tube connector.

[0042] Fig.16 Shown is a schematic diagram of the outer tube connector.

[0043] Fig.17 It is a cross-sectional view around the middle pipe connector of Example 2 of the present application; Fig.18 Display as Fig.17 Enlarged view of part D in the middle.

[0044] Fig.19 Shown is a cross-sectional view of the middle pipe connector of Example 3 of the present application.

[0045] Fig. 20 The heart valve is shown secured to the distal end of the delivery device.

[0046] Fig.21 A heart valve is shown (only a portion of the valve stent is shown), wherein the pull wire composite ring is triangular;

[0047] Fig. 22 Shown is a heart valve (only a portion of the valve stent is shown), in which the pull-wire composite ring is in the shape of a five-pointed star.

[0048] Description of Reference Numerals

[0049] 6 Conveyor handle

[0050] 40 Handle housing

[0051] 1 Inner tube

[0052] 2 Middle pipe

[0053] 3 Outer tube

[0054] 5 Outer sheath

[0055] 501 Pull Wire Channel

[0056] 412 Outer sheath fixing parts

[0057] 413 Fixing hole

[0058] 201 Outer sheath tube connection hole

[0059] 202 Reinforcement

[0060] 203 Pull wire lead-out and drain connection port

[0061] 204 Blocking plate

[0062] 205 Seal

[0063] 60 Cable control knob

[0064] 601 Line Control Bolt

[0065] 602 Cable washer

[0066] 603 Control line sealing ring

[0067] 604 Wire Control Nut

[0068] 605 Wire Exit

[0069] 606 Stepped Hole

[0070] 607 Compression sleeve

[0071] 608 threaded sleeve

[0072] 609 Cut-off ring

[0073] 610 Through hole

[0074] 90 Pull Wire

[0075] Distal release structure:

[0076] 600 Remote Release Knob

[0077] 402 Internal pipe connector

[0078] 81 Inner tube plug section

[0079] 82 first cylindrical fixing block

[0080] 84 Internal pipe thread guide

[0081] 414 First limit column

[0082] Proximal release structure

[0083] 405 External pipe connector

[0084] 500 Proximal Release Knob

[0085] 91 Outer tube plug section

[0086] 92 second cylindrical fixing block

[0087] 93 External pipe connection sealing cover

[0088] 94 External pipe thread guide

[0089] 95 reinforcement

[0090] Valve fixation structure:

[0091] 403 Middle pipe connector

[0092] 51 Middle pipe joint

[0093] 52 third cylindrical fixing block

[0094] 53 Middle pipe connection sealing cover

[0095] 55 Rib

[0096] Regurgitant heart valves:

[0097] 10 Valve stent

[0098] 20 Positioning piece

[0099] 2001 Cable Compound Ring DETAILED DESCRIPTION

[0100] As described in the background art, the heart valve delivery device has many tubes, generally including at least four catheters. If each catheter is provided with an emptying part, the delivery device will not be used. In view of the above problem, it is hoped that a simplified emptying regurgitant heart valve delivery device can be provided for easy use.

[0101] 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", "lower part", "inside", "outside", etc. are based on the orientations or positional relationships shown in the 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.

[0102] Please refer to the attached Figure 1-19It 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.

[0103] Example 1

[0104] See also Figures 1 to 16 The present embodiment provides a simplified emptying regurgitant heart valve delivery device, including a delivery device handle 6, which includes a handle housing 40, a valve delivery tube assembly connected to the handle housing 40, and an outer sheath tube assembly disposed in the handle housing 40. The handle housing 40 is provided with a control line knob 60 connected to the outer sheath tube assembly, and the control line knob 60 is provided with a through hole 610 for external connection to the emptying device; the outer sheath tube assembly includes an outer sheath tube 5 sleeved outside the valve delivery tube assembly and an outer sheath tube fixing member 412 fixed in the handle housing, the outer sheath tube fixing member 412 includes an outer sheath tube plugging hole 201 and an emptying connection port 203 provided with a penetrating outer sheath tube fixing member 412, the outer sheath tube plugging hole 201 is plugged with the outer sheath tube 5, and the through hole 610 is connected with the emptying connection port 203.

[0105] Among them, the through hole 610 of the control line knob 60 is externally connected to an emptying device, for example, a Luer connector is connected, through which it can be connected to an external syringe or other injection device. The outer sheath 5 can be emptied through the control line knob 60, and there is no need to set an emptying component separately on the outer sheath 5.

[0106] It is worth noting that the above-mentioned wire control knob 60 is also used to connect the pull wire. Fig.11 and 12 The outer sheath 5 is provided with a plurality of wire pulling channels 501, one end of the external wire pulling 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 60. That is, by integrating multiple functions into one component, the number of conveyor components is significantly reduced, and the operation is more convenient.

[0107] In a preferred embodiment, the line control knob 60 includes a line control nut 604, a line control washer 602 and a line control bolt 601, and a through hole 610 penetrates the line control nut 604, the line control washer 602 and the line control bolt 601; the line control washer 602 is arranged between the line control bolt and the line control nut 604, the line control nut 604 is screwed with the line control bolt 601, and the through hole 610 extends outward to form a cylindrical pull wire outlet 605 for external emptying syringe. Among them, the cylindrical pull wire outlet 605 is used to connect an external syringe, and use physiological saline or the like to replace the air in the outer sheath tube 5 to realize the emptying of the outer sheath tube 5. One component integrates multiple functions, which significantly reduces the number of conveyor components and makes the operation simpler.

[0108] More 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, thereby assisting in controlling the pulling speed of the pulling wire to avoid external force pulling the pulling wire too fast, and the operation is convenient.

[0109] In one specific embodiment, see Figures 5 to 9 , 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 threads 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.

[0110] Regarding the preferred setting of the wire control washer: 1. The material of the wire control washer 602 is an elastic material, which has deformation characteristics, such as rubber material. The wire control washer 602 can squeeze the wire by controlling the screwing distance between the wire control nut 604 and the wire control bolt 601. 2. 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 wire located therein.

[0111] 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 .

[0112] In a specific embodiment, the upper part of the control line washer 602 is provided with a control line washer loading cavity connected to the control line washer 602, and the control line sealing ring 603 is loaded in the control line washer loading cavity; the control line sealing ring 603 is a hollow boss structure. Specifically, the control line sealing ring 603 is located in the control line washer 602 and faces the side of the control line nut 604. The control line sealing ring 603 is a hollow inverted boss structure, which plays a role in assisting the fixing of the pull wire and sealing. Specifically, the upper part of the control line sealing ring 603 is flush with the upper part of the control line washer 602, and the lower part of the control line washer 602 abuts on the stepped hole 606.

[0113] In a preferred embodiment, see Figure 1 and Figure 2 The outer sheath tube fixing part 412 is arranged at the distal end of the conveyor handle 6. The function of the outer sheath tube fixing part 412 is to limit the axial movement of the outer sheath tube 5 so that it maintains a relatively static state with the second handle shell 42. Therefore, a fixing hole 413 or a protrusion is provided on the outer peripheral surface of the outer sheath tube fixing part 412, and a protrusion or a fixing hole that cooperates with the fixing hole 413 or the protrusion is provided on the inner surface of the second handle shell 42. It is clamped or plugged with the handle shell 40 through the fixing hole 413 to limit the axial position of the adjustment center tube.

[0114] In one specific embodiment, see Fig.11, along the direction from the proximal end to the distal end, the outer sheath tube fixing member 412 includes an outer sheath tube plug hole 201, a wire lead-out and emptying connection port 203, a sealing ring 205 and a blocking plate 204, and the control line knob 60 is plugged into the outer periphery of the outer sheath tube fixing member 412. A reinforcing rib 202 is provided on the outer periphery of the outer sheath tube plug hole 201 to increase the strength of the connector, so that a longer connector can be set, increase its contact area and contact length with the corresponding pipe, and improve the axial stability of the outer sheath tube. The middle part of the wire lead-out and emptying connection port 203 and the control line knob 60 is a hollow channel, which is connected to the wire lead-out and emptying connection port 203 to form an outlet channel for the wire. The wire that passes through the positioning member at the far end passes through the channel on the side wall of the outer sheath tube to the wire lead-out and emptying connection port 203, enters the outlet channel of the wire, and is led out from the upper part of the control line nut.

[0115] In a preferred embodiment, see Figure 1 , 10 , 12-14, the valve delivery tube assembly comprises an inner tube 1, a middle tube 2 and an outer tube 3 which are sleeved in sequence. The valve delivery tube assembly also comprises a distal release structure connected to the inner tube 1, a valve fixing structure connected to the middle tube 2 and a proximal release structure connected to the outer tube 3. Fig.13 The valve fixing mechanism is provided with an emptying passage 701, one end of the emptying passage 701 is connected to the inner tube 1, and the other end is used for an external emptying device, which is used for emptying the middle tube and the outer tube through the interconnecting structure between the tubes.

[0116] Specifically, in an optional embodiment, please refer to Fig.13 Or 18, one end of the emptying passage 701 is not connected to the inner tube 1, but is connected to the middle tube 2, and the other end is used for an external emptying device. More specifically, one end of the emptying passage 701 is connected to the gap pipeline located outside the inner tube 1, and the gap pipeline located outside the inner tube 1 continues into the middle tube connector and is connected to the middle tube 2.

[0117] In a preferred embodiment, see Figure 3 and 13 The distal release structure includes an inner tube connector 402, and the inner tube 1 is connected to the inner tube connector 402. Figure 3The inner tube connector 402 includes a hollow inner tube plug-in section 81 and a first cylindrical fixing block 82. The outer circumference of the first cylindrical fixing block 82 matches the inner circumference of the handle housing 40, and the inner tube 1 is plugged into the inner tube plug-in section 81. The outer circumference of the first cylindrical fixing block 82 matches the inner circumference of the handle housing 40 to increase the contact area between the two. When the cylindrical fixing block 82 moves axially along the handle housing 40, the movement is smoother and there is no shaking, thereby improving the accuracy of valve control. The design of the inner tube plug-in section 81 can correspondingly extend the contact area and contact length between the inner tube connector 402 and the inner tube 1, improve the centrality of the inner tube 1, and reduce the risk of the valve not being released due to the bending or even bending of the inner tube 1 during the axial movement of the inner tube 1.

[0118] More specifically, the distal release structure also includes an inner tube threaded guide 84 arranged on the inner tube connector 402 and a distal release knob 600 threadedly connected to the inner tube threaded guide 84; the handle shell 40 is provided with an inner tube movable guide groove, the inner tube connector 402 is arranged in the handle shell 40, and the inner tube threaded guide 84 can be movably arranged in the inner tube movable guide groove.

[0119] More specifically, a first limiting column 414 is provided in the handle housing 40, which is located at the distal end of the inner tube movement guide groove and is used to limit the movement end point of the inner tube connector 402, that is, the first limiting column 414 is provided near the distal end of the inner tube connector 402, and the first limiting column 414 and the handle housing 40 jointly form a movement space of the inner tube connector 402 to ultimately limit the axial movement distance of the inner tube 1. That is, the inner tube movement guide groove and the first limiting column 414 jointly ensure the stability of the inner tube movement.

[0120] More specifically, an inner tube emptying tube 401 is provided at the proximal end of the inner tube connector 402, which is used to inject physiological saline to expel the air in the inner tube. Specifically, a through hole is provided in the middle portion of the inner tube connector 402, and the distal end of the inner tube emptying tube 401 passes through the through hole and is connected with the inner tube 1 inside the cylindrical fixed block 82. When operating the conveyor, physiological saline or the like is injected into the inner tube emptying tube 401 to expel the air in the inner tube. For example, the inner tube emptying tube 401 is connected to a Luer connector, through which it can be connected to an external syringe or other injection device.

[0121] In a preferred embodiment, referring to 3, 13 and 15, the valve fixing structure includes a middle tube connector 403 fixedly arranged in the handle housing 40, the middle tube 2 is connected to the middle tube connector 403, and the evacuation passage 701 is passed through the middle tube connector 403 and communicated with the inner tube 1. Specifically, referring to Fig.15 The middle tube connector 403 includes a hollow middle tube plug-in section 51 and a third cylindrical fixing block 52. The outer circumference of the third cylindrical fixing block 52 matches the inner circumference of the handle housing 40. The middle tube 2 is plugged into the middle tube plug-in section 51. More specifically, see Fig.15 The middle tube connector 403 also includes a middle tube connection sealing cover 53. The middle tube plug-in section 51 and the middle tube connection sealing cover 53 are respectively connected to the distal end and the proximal end of the third cylindrical fixing block 52. The middle tube connection sealing cover 53 plays a good sealing role.

[0122] As Fig.13 and 15 As shown, the middle tube plug section 51 has a certain length, which can correspondingly extend the contact area and contact length between the middle tube connector 403 and the middle tube 2, and keep the position of the middle tube 2 relative to the handle housing 40 unique and stable. Therefore, the following structural settings are made to facilitate stability: Specifically, refer to Fig.15 The third cylindrical fixing block 52 is provided with at least one insertion hole 54, and a plug pin that matches the insertion hole 54 is provided on the inner side of the handle housing 40. The plug pin is inserted into the insertion hole 54 to limit the axial position of the middle pipe connector 403 to maintain relative stillness with the handle housing 40. More specifically, refer to Fig.15 The outer periphery of the middle pipe inserting section 51 is provided with a radial rib 55, and one end of the rib 55 is connected to the third cylindrical fixing block 52. The radial rib 55 plays a role of further fixing.

[0123] In a preferred embodiment, Figure 1 , 14 and 16, the proximal release structure includes an outer tube connector 405, and the outer tube 3 is connected to the outer tube connector 405. Specifically, the proximal release structure is substantially the same as the distal release structure, the outer tube connector 405 includes a hollow outer tube plug-in section 91 and a second cylindrical fixing block 92, the outer periphery of the second cylindrical fixing block 92 matches the inner periphery of the handle housing 40, the outer tube is plugged into the outer tube plug-in section 91, and the outer periphery of the second cylindrical fixing block 92 is provided with an outer tube threaded guide 94, and the outer tube threaded guide 94 passes through the outer tube moving guide groove and is threadedly connected to the proximal release knob 500. The second cylindrical fixing block 92 is provided so that it can fit with the handle housing 40 to increase the contact area between the two. When the second cylindrical fixing block 92 moves axially along the handle housing 40, the movement is more stable and there is no shaking, thereby improving the accuracy of valve control. The design of the outer tube plug section 91 can correspondingly extend the contact area and contact length between the outer tube connector 405 and the outer tube 3, improve the centrality of the outer tube 3, and reduce the risk of the valve not being released due to bending or even folding of the inner tube during axial movement of the outer tube 31.

[0124] See also Fig.16 The outer tube plug section 91 is provided with a reinforcing rib 95 on the outside. The reinforcing rib 95 gradually increases in radial direction from the distal end to the proximal end until it is connected to the inner side wall of the second cylindrical fixing block 92. More specifically, see Fig.19The outer tube connector 405 further includes an outer tube connection sealing cover 93. The outer tube plug section 91 and the outer tube connection sealing cover 93 are respectively connected to the distal end and the proximal end of the second cylindrical fixing block 92. The outer tube connection sealing cover 93 plays a good sealing role. It is worth noting that the proximal release structure is basically the same as the distal release structure, and the specific structures of the two can refer to each other.

[0125] Example 2

[0126] Embodiment 2 is based on embodiment 1 and has made some improvements. The improvement is that, referring to Fig.17 and 18 A middle-inner tube passage 120 connecting the middle tube 2 and the inner tube 1 is provided between the middle tube 2 and the inner tube 1, that is, the emptying passage 701 serves as a common emptying port for the middle tube 2 and the inner tube 1. Preferably, the middle-inner tube passage 120 is arranged near the proximal end of the middle tube 2.

[0127] Generally, the saline solution for emptying is sucked from the far end of the pipeline to the proximal end of the pipeline to empty the pipeline. Therefore, it is more preferred that a middle inner tube passage 120 is opened at the very end of the middle tube 2 to ensure that the saline solution for emptying can completely fill the middle tube 2 to ensure that there is no air dead corner in the middle tube 2.

[0128] In a preferred embodiment, a middle-outer tube passage connecting the middle tube 2 and the outer tube 3 is provided between the middle tube 2 and the outer tube 3, that is, the emptying passage 701 is used as a common emptying port of the outer tube, the middle tube 2, and the inner tube 1. Preferably, the middle-outer tube passage is provided near the proximal end of the outer tube 3. As above, more preferably, the middle-outer tube passage is provided at the very end of the outer tube to ensure that the saline used for emptying can completely fill the outer tube 3, so as to ensure that there is no dead corner of air in the outer tube 3.

[0129] Example 3

[0130] See also Fig.18 Or 19, the valve delivery tube assembly also includes a reinforcing tube 7, which is sleeved outside the middle tube 2, and the distal end of the reinforcing tube 7 is sleeved into the outer tube 3, and a middle-strong tube passage 801 connecting the reinforcing tube 7 and the middle tube 2 is provided between the reinforcing tube 7 and the middle tube 2, and a middle-inner tube passage 120 connecting the middle tube 2 and the inner tube 1 is provided between the middle tube 2 and the inner tube 1. That is, the outer tube 3 is connected to the middle tube connector by setting the reinforcing tube 7. Finally, the middle-inner tube passage 120 cooperates with the reinforcing tube 7 to realize that the outer tube 3, the middle tube 2 and the inner tube 1 can share the emptying passage 701. Preferably, the middle-inner tube passage 120 is arranged near the proximal end of the middle tube 1, and the middle-strong tube passage 801 is arranged near the proximal end of the reinforcing tube to ensure that the saline used for emptying can completely fill the middle tube 2 and the reinforcing tube 7, so as to ensure that there is no air dead corner in the middle tube 2 and the reinforcing tube 7. In addition, the reinforcing tube 7 can also play the role of reinforcing pipe fittings.

[0131] Example 4

[0132] This embodiment provides a precisely adjustable regurgitant heart valve delivery system, comprising a regurgitant heart valve and the simplified and emptied regurgitant heart valve delivery device of embodiments 1 to 3. 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, 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.

[0133] 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, one end of each pull wire 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.

[0134] See also Figure 1 , 2 20-22, a precisely positioned regurgitant heart valve delivery system, comprising a regurgitant heart valve and a regurgitant heart valve delivery device, wherein the regurgitant heart valve comprises a valve stent 10 and a valve connected to the valve stent, and the valve stent 10 comprises a plurality of positioning members 20. Specifically, a pull-wire composite ring 2001 is provided at the free end of the positioning member 20, and a pull-wire hole is provided in the pull-wire composite ring 2001. Preferably, the material of the pull-wire composite ring 2001 is a developing material. Specifically, a mark "marker" is provided at the distal end of a conventional positioning member. The mark is 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 pull-wire composite ring 2001 of this embodiment cancels the "marker" installation hole, but sets the pull-wire composite ring 2001 itself to have a developing function, thereby increasing the safety of the user. An X-ray-proof marking layer may be provided on the surface of the connecting plate of the wire drawing composite ring 2001 or a high-density metal plating layer may be added to the surface of the connecting plate, so that the wire drawing composite ring 2001 can be more clearly seen under X-rays.

[0135] Preferably, the wire pull compound ring 2001 is a regular or irregular geometric shape, that is, the outer contour of the connecting plate of the wire pull 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 wire pull compound ring 2001 has a specific shape, which is convenient for operators to quickly identify the wire pull compound ring 2001, thereby replacing the mark "marker".

[0136] 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 streamlined emptying regurgitant heart valve delivery device, comprising a delivery device handle (6), wherein the delivery device handle (6) comprises a handle housing (40), a valve delivery tube assembly connected to the handle housing (40), and an outer sheath tube assembly disposed in the handle housing (40); It is characterized in that The handle housing (40) is provided with a wire control knob (60) which is in communication with the outer sheath tube assembly, and the wire control knob (60) is provided with a through hole (610) for connecting an external evacuator; The outer sheath tube assembly is sleeved on an outer sheath tube (5) outside the valve delivery tube assembly and an outer sheath tube fixing member (412) fixed in the handle shell, the outer sheath tube fixing member (412) includes an outer sheath tube plug hole (201) and an emptying connection port (203) that penetrates the outer sheath tube fixing member (412), the outer sheath tube plug hole (201) is plugged with the outer sheath tube (5), and the through hole (610) is connected with the emptying connection port (203).

2. The streamlined evacuation regurgitant heart valve delivery device according to claim 1, characterized in that: It also includes at least one of the following technical features: a1) the outer sheath tube (5) is provided with a plurality of wire pulling channels (501), one end of the external wire pulling channel 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 (60); a2) the wire control knob (60) comprises a wire control nut (604), a wire control washer (602) and a wire control bolt (601), the through hole (610) penetrates 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), the wire control nut (604) is threadedly connected to the wire control bolt (601), and the through hole (610) extends outward to form a cylindrical wire pulling outlet (605) for externally connecting an emptying syringe; a3) the material of the wire control washer (602) is elastic material; a4) the outer sheath tube fixing member (412) further comprises a blocking plate (204) and a sealing ring (205) arranged at the proximal end of the outer sheath tube fixing member (412); a5) A reinforcing rib (202) is provided on the outer periphery of the outer sheath tube insertion hole (201).

3. The streamlined evacuation regurgitant heart valve delivery device according to claim 2, characterized in that: The line control nut (604) comprises 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 diameter 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 threadedly connected to the line control bolt (601), and the pressing sleeve (607) presses the upper end of the line control washer (602); And / or, the line control knob further comprises a line control sealing ring (603), the line control sealing ring (603) is located inside the line control washer (602) and faces one side of the line control nut (604), and the line control sealing ring (603) is a hollow inverted boss structure; And / or, the line control washer (602) comprises 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 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 line control nut (604), and the stop ring (609) is used as a threading end point.

4. The streamlined evacuation regurgitant heart valve delivery device according to claim 1, characterized in that: The valve delivery tube assembly comprises an inner tube (1), a middle tube (2) and an outer tube (3) which are sleeved in sequence; The valve delivery tube assembly further comprises a distal release structure connected to the inner tube (1), a valve fixing structure connected to the middle tube (2), and a proximal release structure connected to the outer tube (3); The valve fixing mechanism is provided with an emptying passage (701), one port of the emptying passage (701) is connected to the inner tube (1), and the other port is used for an external emptying device; and / or, one port of the emptying passage (701) is connected to the middle tube (2), and the other port is used for an external emptying device.

5. The simplified evacuation regurgitant heart valve delivery device according to claim 4, characterized in that: A middle-inner tube passage (120) is provided between the middle tube (2) and the inner tube (1) for connecting the middle tube (2) and the inner tube (1); And / or, a middle-outer tube passage is provided between the middle tube (2) and the outer tube (3) for connecting the middle tube (2) and the outer tube (3).

6. The simplified evacuation regurgitant heart valve delivery device according to claim 5, characterized in that: Include at least one of the following technical features: b1) the distal release structure comprises an inner tube connector (402), and the inner tube (1) is connected to the inner tube connector (402); b2) the valve fixing structure comprises a middle tube connector (403) fixedly arranged in the handle housing (40), the middle tube (2) is connected to the middle tube connector (403), and the emptying passage (701) is passed through the middle tube connector (403) and communicated with the inner tube (1); b3) the proximal release structure comprises an outer tube connector (405), and the outer tube (3) is connected to the outer tube connector (405); b4) the middle inner tube passage (120) is arranged close to the proximal end of the middle tube (2); b5) The middle and outer tube passage is arranged close to the proximal end of the outer tube (3).

7. The streamlined evacuation regurgitant heart valve delivery device according to claim 6, characterized in that: It also includes at least one of the following technical features: b11) the inner tube connector (402) comprises a hollow inner tube plug-in section (81) and a first cylindrical fixing block (82), the outer circumference of the first cylindrical fixing block (82) matches the inner circumference of the handle housing (40), and the inner tube (1) is plugged into the inner tube plug-in section (81); b12) The distal release structure further comprises an inner tube threaded guide (84) provided on the inner tube connector (402) and a distal release knob (600) threadedly connected to the inner tube threaded guide (84); the handle housing (40) is provided with an inner tube movable guide groove, the inner tube connector (402) is provided in the handle housing (40), and the inner tube threaded guide (84) is movably provided in the inner tube movable guide groove; b13) An inner tube drain pipe (401) is provided at the proximal end of the inner tube connector (402); b21) the middle tube connector (403) comprises a hollow middle tube plug-in section (51) and a third cylindrical fixing block (52), the outer circumference of the third cylindrical fixing block (52) matches the inner circumference of the handle housing (40), and the middle tube (2) is plugged into the middle tube plug-in section (51); b31) the outer tube connector (405) comprises a hollow outer tube plug-in section (91) and a second cylindrical fixing block (92), the outer circumference of the second cylindrical fixing block (92) matches the inner circumference of the handle housing (40), and the outer tube (3) is plugged into the outer tube plug-in section (91); b32) The proximal release structure also includes an outer tube threaded guide (94) arranged on the outer tube connecting head and a proximal release knob (500) threadedly connected to the outer tube threaded guide (94); the handle shell (40) is provided with an outer tube movable guide groove, the outer tube connecting head (405) is arranged in the handle shell (40), and the outer tube threaded guide can be movably arranged in the outer tube movable guide groove.

8. The streamlined evacuation regurgitant heart valve delivery device according to claim 4, characterized in that: The valve delivery tube assembly also includes a reinforcing tube (7), the reinforcing tube (7) is sleeved outside the middle tube, and the distal end of the reinforcing tube (7) is sleeved into the outer tube (3), and a middle-strong tube passage (801) connecting the reinforcing tube (7) and the middle tube (2) is provided between the reinforcing tube (7) and the middle tube (2); and a middle-inner tube passage (120) connecting the middle tube (2) and the inner tube (1) is provided between the middle tube (2) and the inner tube (1).

9. The streamlined evacuation regurgitant heart valve delivery device according to claim 8, characterized in that: The middle inner tube passage (120) is arranged close to the proximal end of the middle tube (2); and the middle strong tube passage (801) is arranged close to the proximal end of the strengthening tube.

10. A precisely adjustable regurgitant heart valve delivery system, characterized in that: The invention comprises a regurgitant heart valve and a simplified evacuated regurgitant heart valve delivery device as claimed in any one of claims 1 to 9.

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