CN117752467A

CN117752467A - Precise-positioning regurgitation heart valve conveyor and conveying system

Info

Publication number: CN117752467A
Application number: CN202311242718.7A
Authority: CN
Inventors: 戴志成; 耿肖肖; 葛云龙; 黄彦青; 陈真; 王春光; 龚书珺; 吴明明; 陈大凯
Original assignee: Koka Nantong Lifesciences Co Ltd
Current assignee: Koka Nantong Lifesciences Co Ltd
Priority date: 2022-03-28
Filing date: 2023-09-25
Publication date: 2024-03-26
Also published as: CN219000720U; CN115381598A; CN115670750B; CN115381597A; CN115624416A; CN116869705A; CN116807686A; CN116849869A; CN117752468A; CN219000725U; CN115105259A; WO2023184639A1; CN218356472U; CN218792636U; CN116807685A; CN218356471U; CN116807684A; CN116849870A; CN218792637U; CN115624416B

Abstract

The application provides a reverse flow heart valve conveyor and conveying system conveyor of accurate location belongs to medical instrument technical field. The conveyor comprises a conveyor handle for conveying the regurgitant heart valve, the distal end of the conveyor handle for securing the regurgitant heart valve, the regurgitant heart valve comprising a plurality of positioning members. The conveyor handle comprises a plurality of locating piece adjusting structures, and each locating piece adjusting structure is used for adjusting the opening angle of each locating piece. The conveyer of this application no longer relies on the self-expanding of setting element to open, but controls the angle of opening of three setting element respectively through the triplex acting as go-between, according to unique aortic anatomy in the art, with the angle modulation of three setting element respectively, operate again in order to guarantee that three setting element all can get into the sinus bottom smoothly to adapt to complicated aortic anatomy, and improve the convenience of operation.

Description

Precise-positioning regurgitation heart valve conveyor and conveying system

Technical Field

The application relates to the technical field of medical equipment for heart valve repair, in particular to a reverse flow heart valve conveyor and a conveying system with accurate positioning.

Background

The heart comprises two chambers, the chambers of the heart and the outside are separated by a mitral valve, a tricuspid valve, an aortic valve and a pulmonary valve, respectively. 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.

The aortic valve connects the left ventricle and the aorta, when the left ventricle expands, the aortic valve is in a closed state, when the left ventricle contracts, the aortic valve is in an open state, and the oxygenated blood in the left ventricle is pumped into the main artery by the contraction pump and is sent to all parts of the whole body through the aorta. Because the systolic pressure is larger when the heart contracts, the systolic pressure is generally 120mmHg, the position of an aortic valve is special even up to 150mmHg, the aortic valve is close to the mitral valve annulus, and for an aortic regurgitation patient, the fixation of the regurgitation valve is considered, and the normal operation of other valves is prevented from being influenced.

The traditional aortic valve replacement is a mode of establishing extracorporeal circulation at the thoracic median incision, the aorta and the right atrium cannula, but the traditional surgery has great damage to patients and long recovery period, and especially for elderly patients, the damage to the body caused by the traditional surgery is difficult to bear. Since the transcatheter operation has many advantages such as less trauma and quick recovery, more and more operations are performed by using the transcatheter operation, and the research of aortic valve replacement is gradually changed from the early surgical mode to the transcatheter aortic valve replacement mode.

The regurgitation stent used in transcatheter aortic replacement is typically inserted into the sinus floor of the native aortic valve by three positioning members prior to release of the regurgitation stent, and after complete release of the regurgitation stent, the positioning members, along with the rest of the regurgitation stent, secure the regurgitation stent by the native aortic valve and the aortic wall. However, the existing positioning piece of the reverse flow stent is opened by a certain angle by virtue of self elasticity, or the positioning piece is incompletely released, and the like, so that the problem that the positioning piece is difficult to insert into the sinus floor because the diameter of a circle where three positioning pieces are positioned is smaller than the diameter of an aortic valve ring in clinical application exists.

Aiming at the problems, the positioning conveyor for the reverse flow heart valve is expected to be provided with accurate positioning, and the opening angles of the three positioning pieces are regulated and controlled respectively, so that the three positioning pieces can smoothly enter the sinus floor, the convenience of operation is improved, and the positioning conveyor is suitable for complex aortic anatomy structures.

Disclosure of Invention

In view of the above-mentioned problems of the prior art, a main object of the present application is to provide a positioning conveyor for a regurgitation heart valve with accurate positioning, which does not rely on self-expansion of positioning members, but controls opening angles of three positioning members respectively through three stay wires, wherein the angles of the three positioning members are adjusted according to unique aortic anatomy in operation, and the three positioning members can be smoothly entered into the sinus floor for adapting to complex aortic anatomy, and improving convenience of operation.

To achieve the above and other related objects, a first aspect of the present application provides a positioning-accurate regurgitant heart valve transporter comprising a transporter handle for transporting a regurgitant heart valve, a distal end of the transporter handle for fixing the regurgitant heart valve, the regurgitant heart valve comprising a plurality of positioning members; the conveyor handle comprises a plurality of locating piece adjusting structures, and each locating piece adjusting structure is used for adjusting the opening angle of each locating piece.

In one possible implementation of the first aspect, the delivery handle comprises a handle housing, a valve delivery tube assembly connected to the handle housing, and an outer sheath tube assembly disposed within the handle housing; the outer sheath tube assembly comprises an outer sheath tube sleeved outside the valve conveying assembly, and the outer sheath tube is provided with a plurality of positioning stay wire channels;

the positioning piece adjusting structure comprises a plurality of positioning stay wires and a wire control knob, and the wire control knob is arranged on the handle shell;

the reverse flow heart valve is fixed at the far end of the valve conveying pipe assembly, one side end of the positioning stay wire is connected with the free end of the positioning piece, and the other side end of the positioning stay wire sequentially penetrates through the positioning stay wire channel and the handle shell and then is connected with the control wire knob.

In an implementation manner of the first aspect, the positioning stay is disposed in the positioning stay channel in a turned-back state.

As a preferable scheme, the free end of the locating piece is provided with a stay wire hole, one end of the locating stay wire is connected with the wire control knob, sequentially passes through the locating stay wire channel and the stay wire hole, sequentially passes through the locating stay wire channel and the handle shell, and then is connected with the wire control knob.

As a preferable scheme, the outer sheath tube is provided with a plurality of groups of positioning stay wire channels, the number of the groups of positioning stay wire channels is the same as that of the positioning piece adjusting structures, and each group of positioning stay wire channels comprises a wire removing channel and a wire returning channel;

the positioning stay wire comprises a stay wire removing channel and a stay wire returning channel which are integrally connected, the stay wire removing channel and the stay wire returning channel are respectively arranged, the connecting part of the stay wire removing channel and the stay wire returning channel is connected with the positioning piece, and the free ends of the stay wire removing channel and the stay wire returning channel are connected with the wire control knob.

In one possible implementation manner of the first aspect, the control wire knob includes a control wire nut including a pressing sleeve, a control wire gasket, and a control wire bolt including a stepped hole; the wire control knob is provided with a through hole, the through hole penetrates through the wire control nut, the wire control gasket and the wire control bolt, and the positioning stay wire penetrates through the through hole;

In the assembled state, the control wire bolt is in threaded connection with the control wire nut, the control wire gasket is positioned in the stepped hole, and the pressing sleeve presses the upper end of the control wire gasket; and adjusting the extrusion force of the control wire gasket on the positioning stay wire by controlling the screwing distance between the control wire nut and the control wire bolt.

Preferably, the through hole of the control wire nut extends outwards to form a hollow cylindrical stay wire outlet for connecting with an external syringe.

As a preferable scheme, the control wire knob further comprises a control wire sealing ring, wherein the control wire sealing ring is positioned at one side of the control wire gasket facing to the control wire nut, and the control wire sealing ring is of a hollow inverted boss structure;

as a preferable scheme, the control line gasket comprises a middle gasket and two end gaskets positioned at two sides of the middle gasket, wherein the outer diameter of the middle gasket is smaller than that of the two end gaskets;

preferably, the control wire gasket is made of elastic material;

as a preferable scheme, the control line bolt sequentially comprises a bolt part, a stop ring and an insertion part from top to bottom; the control line nut is also provided with a threaded sleeve, the bolt part is in threaded connection with the threaded sleeve, and the stop ring is used as a threaded connection terminal point.

In an implementation manner of the first aspect, the positioning member adjusting structure further includes a positioning stay wire fixing member, where the positioning stay wire fixing member is disposed on the handle housing, and after the positioning stay wire is connected with the wire control knob, the positioning stay wire is connected with the positioning stay wire fixing member.

As a preferable scheme, the lower part of the positioning stay wire fixing piece is a pin column, and the outer diameter of the pin column is matched with the inner diameter of the through hole of the control wire knob.

In one embodiment of the first aspect, the valve delivery tube assembly comprises an inner tube, a middle tube and an outer tube that are sequentially sleeved, a proximal end of the regurgitant heart valve is captured between the middle tube and the outer tube, a distal end is captured between the middle tube and the inner tube, and a connecting end of the positioning member is proximal to the proximal end of the regurgitant heart valve and a free end is proximal to the distal end of the regurgitant heart valve.

Preferably, the inner tube comprises an inner tube and a front loading head sheath at the distal end of the inner tube; the outer tube includes an outer tube and a rear loading sheath at a distal end of the outer tube; the middle pipe fitting comprises a middle pipe, and a first step groove, a valve bearing part and a second step groove are formed in the middle pipe from the distal end of the middle pipe to the proximal end; the front loading head sheath is matched with the first stepped groove to form a front loading bin, and the rear loading sheath is matched with the second stepped groove to form a rear loading bin.

Preferably, the valve delivery tube assembly further comprises a distal release structure connected to the inner tube, a valve securing structure connected to the middle tube, and a proximal release structure connected to the outer tube; the valve fixing structure is fixedly connected with the handle shell; the distal release mechanism is slidably connected with the handle shell and is used for driving the inner pipe to move along the axial direction of the handle shell; the proximal release mechanism is slidably coupled to the handle housing for driving the outer tubular member to move axially along the handle housing.

As a preferable scheme, the distal release structure comprises an inner pipe connector, an inner pipe thread guide piece arranged on the inner pipe connector and a distal release knob in threaded connection with the inner pipe thread guide piece; the handle shell is provided with an inner pipe moving guide groove, the inner pipe connector is arranged in the handle shell, the inner pipe threaded guide piece is movably arranged in the inner pipe moving guide groove, and the inner pipe piece is connected with the inner pipe connector. As a preferable scheme, the inner pipe connector comprises a hollow inner pipe inserting section and a first cylindrical fixing block, the periphery of the first cylindrical fixing block is matched with the inner periphery of the handle shell, and the inner pipe piece is inserted into the inner pipe inserting section; and/or a first limit column is arranged in the handle shell and is positioned at the far end of the inner tube moving guide groove and used for limiting the moving end point of the inner tube connector. And as a preferable scheme, the outer part of the inner pipe plug-in section is provided with reinforcing ribs which gradually grow from the far end to the near end along the radial direction until the reinforcing ribs are connected to the inner side wall of the first cylindrical fixed block.

Preferably, the proximal release structure comprises an outer tube connector, an outer tube thread guide piece arranged on the outer tube connector and a proximal release knob screwed with the outer tube thread guide piece; the handle shell is provided with an outer tube moving guide groove, the outer tube connector is arranged in the handle shell, and the outer tube thread guide piece is movably arranged in the outer tube moving guide groove. Preferably, the outer tube connector comprises a hollow outer tube inserting section and a second cylindrical fixed block, the periphery of the second cylindrical fixed block is matched with the inner periphery of the handle shell, the outer tube is inserted into the outer tube inserting section, an outer tube thread guide member is arranged on the periphery of the second cylindrical fixed block, and the outer tube thread guide member penetrates through the outer tube moving guide groove to be in threaded connection with the proximal release knob. Still more preferably, the method further comprises,

the outer tube connector also comprises an outer tube connecting sealing cover; and/or the outer part of the outer tube inserting section is provided with reinforcing ribs, and the reinforcing ribs gradually grow from the distal end to the proximal end until the reinforcing ribs are connected to the inner side wall of the second cylindrical fixing block. As a preferred scheme, the valve fixing structure comprises a middle pipe connector fixedly arranged in the handle shell, the middle pipe connector comprises a hollow middle pipe inserting section and a third cylindrical fixing block, the periphery of the third cylindrical fixing block is matched with the inner periphery of the handle shell, and the middle pipe fitting is inserted into the middle pipe inserting section.

As a preferable scheme, the third cylindrical fixed block is provided with at least one jack, and the inner side of the handle shell is provided with a plug post matched with the jack; and/or the periphery of the middle pipe inserting section is provided with radial rib plates, and one end of each rib plate is connected with the third cylindrical fixing block. And as a preferable scheme, a third limit column is arranged in the handle shell, and the third limit column is propped against the rib plate.

In an embodiment of the first aspect, the conveyor handle further includes a centering structure, the centering structure including at least one centering wire, a centering sleeve with internal threads, and a threaded slider in threaded connection with the centering sleeve, rotation of the centering sleeve being used to drive axial movement of the threaded slider along the centering sleeve; the proximal end of the centering stay wire is arranged on the threaded sliding block, and the distal end of the centering stay wire is connected with the outer sheath tube.

Preferably, the centering structure further comprises a guide cylinder fixed in the handle shell, the guide cylinder is positioned outside the valve conveying pipe assembly, and the thread sliding block is movably sleeved outside the guide cylinder.

As a preferable scheme, the outer sheath tube is also provided with at least one centering stay wire cavity, and the centering stay wire is arranged in the centering stay wire cavity in a penetrating way and the far end of the centering stay wire cavity is connected with the outer sheath tube; and/or, the centering structure further comprises a fixed disc arranged at the far end of the guide cylinder, the fixed disc is provided with an anti-rotation lug, the handle shell is provided with a fixed connecting block with a fixed hole, and the anti-rotation lug is spliced with the fixed hole; and/or the periphery of the guide cylinder is provided with a guide strip, and the thread slider is provided with a guide groove matched with the guide strip.

And as a preferable scheme, the center-adjusting stay wire is of a sheet-shaped structure, and the cross section of the center-adjusting stay wire cavity is of a rectangular structure.

And as a preferable scheme, the centering structure further comprises a center sliding block movably sleeved outside the guide cylinder, the center sliding block is arranged at the proximal end side of the threaded sliding block, and the proximal end of the centering stay wire penetrates through the threaded sliding block and then is connected with the center sliding block.

In one possible implementation of the first aspect the transporter handle comprises a valve control portion and a valve release portion, the valve delivery tube assembly being connected to the valve release portion and the outer sheath being connected to the valve control portion;

the conveyor handle also comprises a valve pushing structure for driving the valve conveying pipe assembly to axially move along the conveyor handle; the valve advancing structure comprises a valve advancing sleeve which is arranged in the handle shell in a sliding mode, and the valve advancing sleeve is connected with the valve releasing part.

As a preferable scheme, the valve pushing structure further comprises a valve pushing knob, the valve pushing sleeve is provided with a pushing thread guide member, the handle shell is provided with a pushing axial guide groove, the pushing thread guide member is movably arranged in the pushing axial guide groove, and the pushing thread guide member is in threaded connection with the valve pushing knob.

As a preferable scheme, the valve pushing structure further comprises a connecting knob, and a connecting gear is arranged at the proximal end of the valve pushing sleeve;

the valve pushing sleeve is positioned at the junction of the valve control part and the valve releasing part, and a handle shell positioned at the valve releasing part is provided with a threaded hole; the connecting knob is in threaded connection and is in clamping connection with the connecting gear after passing through the threaded hole.

In an embodiment of the first aspect, the transporter handle further comprises an evacuation structure in communication with the valve delivery tube assembly for evacuating air from the valve delivery tube assembly.

In an implementation manner of the first aspect, the outer sheath tube assembly further includes an outer sheath tube fixing member fixedly disposed in the handle housing, the outer sheath tube fixing member includes an outer sheath tube inserting hole and an evacuation connection port, the outer sheath tube inserting hole is inserted into the outer sheath tube, and the through hole of the control wire knob is communicated with the evacuation connection port.

Preferably, the sheath tube fixing member is provided with a stay wire channel, the proximal end of the centering stay wire is arranged on the threaded slider, and the distal end of the centering stay wire penetrates through the stay wire channel and then is connected with the sheath tube.

As a preferable scheme, the outer sheath fixing piece further comprises a plugging plate and a sealing ring which are arranged at the proximal end of the outer sheath fixing piece; and/or the periphery of the outer sheath tube inserting hole is provided with a reinforcing rib.

A second aspect of the present application provides a precisely positioned regurgitant heart valve delivery system comprising a regurgitant heart valve and a regurgitant heart valve delivery device according to the first invention; the regurgitant heart valve includes a valve holder and a valve coupled to the valve holder, the valve holder including a plurality of positioning members.

In one possible implementation manner of the second aspect, the free end of the positioning piece is provided with a pull wire composite ring, and the pull wire hole is formed in the pull wire composite ring.

Preferably, the material of the stay wire composite ring is a developing material; and/or the pull-wire composite ring is regular or irregular geometric shape.

The precise positioning regurgitation heart valve transporter and system provided by the application has the following beneficial effects, but is not limited to:

1) The conveyer is provided with a plurality of locating piece adjusting structures, and each locating piece adjusting structure is used for adjusting the opening angle of each locating piece respectively, so that the opening angle of each locating piece is independently controlled. For example, when the opening angle of the positioning piece after self-expansion is too small, or the specificity of the sinus floor anatomical structure of a patient, the opening angle of each positioning piece can be independently controlled, so that each positioning piece can smoothly enter the sinus floor, and the positioning piece is suitable for a complex aortic anatomical structure, thereby being beneficial to improving the convenience and accuracy of operation.

2) The locating piece adjusting structure controls the tension of the locating stay wire through the wire control knob, the operation is convenient, the wire control knob can be used as an emptying port of the outer sheath tube, and on the premise that the conveying requirement of the conveyor is met, one component is integrated with multiple functions, so that the number of components of the conveyor is obviously reduced, and the operation is simpler.

3) The valve centering structure and other parts are designed into an integrated structure, and the whole conveyer is in an axisymmetric barrel-shaped structure, so that the valve centering structure is more convenient for fixing and the operation of medical staff.

4) The whole conveyer is designed into an integrated structure, and the connecting knob controls the valve control part and the valve release part to synchronously move or separately and independently rotate so as to correspondingly complete the conveying or rotation of the valve.

Drawings

Fig. 1 shows an overall schematic view of a conveyor according to example 1 of the present application.

Fig. 2a shows an enlarged view of a portion of a conveyor head end as described in example 1 of the present application.

FIG. 2b shows a state diagram of a heart valve (only a valve stent is shown) as described herein, wherein b1 is the initial state after release of the positioning member; b2 is a state that when the positioning pull wire and the free end of the fixing piece are kept motionless, the heart valve moves to the proximal end so that the positioning piece opens a certain angle; b3 is the self-expanding and releasing state of the heart valve after the position relation between the inner tube and the outer tube and the middle tube is adjusted.

Fig. 3 is a schematic view showing a structure of a handle housing of a cut-away portion of a conveyor according to embodiment 1 of the present application.

Fig. 4 shows an exploded view of the conveyor according to example 1 of the present application.

Fig. 5 is an enlarged view of the portion G in fig. 4.

Fig. 6 shows a longitudinal section of the conveyor according to example 1 of the present application.

FIG. 7 is an enlarged view of portion A of FIG. 6; FIG. 8 is an enlarged view of portion A1 of FIG. 7; fig. 9 is an enlarged view of a portion A2 in fig. 7.

Fig. 10 shows a transversal cross-section of the outer sheath.

FIG. 11a is an enlarged view of portion B of FIG. 6; fig. 11b shows a schematic view of the structure of the outer sheath fixing member.

Fig. 12 is an enlarged view of the portion F in fig. 3.

FIG. 13 is a schematic view showing the overall structure of a control knob; FIG. 14 is an exploded view of the control knob in elevation; FIG. 15 is an exploded view of a control knob at a squint angle; FIG. 16 is a schematic view showing the structure of a control line bolt; fig. 17 shows a schematic structure of the control wire nut.

Fig. 18 is an enlarged view of the portion E in fig. 3.

FIG. 19 is a schematic view showing the structure of the outer tube joint; fig. 20 is an enlarged view of the portion H in fig. 6.

Fig. 21 shows a schematic structure of the middle tube connector.

Fig. 22 shows an exploded view of the centering structure.

Fig. 23 is an enlarged view of the portion C in fig. 6.

Fig. 24 is an enlarged view of the portion D in fig. 6.

Fig. 25-28 are partial schematic views of the positioning member.

Description of the reference numerals

6. Conveyor handle

40. Handle shell

41. First handle shell

803. Axial limiting piece

42. Second handle shell

611. Valve control unit

612. Valve release

613. Connecting part

Valve delivery tube assembly and sheath tube assembly:

1. inner pipe

11. Front loading head sheath

2. Middle pipe

21. First step groove

22. Valve bearing part

23. Second step groove

3. Outer tube

31. Rear loading sheath

5. Outer sheath tube

501. Positioning stay wire channel

502. Center-adjusting stay wire cavity

5021. Pull wire guide groove

100. Second sleeve barrel

412. Outer sheath tube fixing piece

413. Fixing hole

912. Stay wire channel

201. Plug hole of outer sheath tube

202. Reinforcing rib

203. Stay wire leading-out and emptying connecting port

204. Plugging plate

205. Sealing ring

Centering structure:

200. centering knob

410. Center-adjusting stay wire

4101. Protruding structure

409. Centering sleeve

906. Guide cylinder

904. Fixed disk

907. Screw thread slider

908. Center slide block

Film advancing structure:

300. valve pushing knob

400. Connection knob

408. Valve pushing sleeve

406. Reinforcing sleeve

407. Connecting gear

420. Advancing screw guide

Positioning piece adjusting structure:

60. wire control knob

601. Wire control bolt

602. Wire control cushion ring

603. Control line sealing ring

604. Wire control nut

605. Stay wire outlet

606. Stepped hole

607. Pressing sleeve

608. Threaded sleeve

609. Cut-off ring

70. Positioning stay wire fixing piece

90. Positioning stay wire

500. Proximal release knob

Distal release structure:

600. distal release knob

402. Inner pipe connector

81. Inner pipe plug-in section

82. First cylindrical fixing block

84. Inner pipe thread guide

414. First spacing post

Proximal release structure

405. Outer tube connector

91. Outer tube plug-in section

92. Second cylindrical fixing block

93. Sealing cover for outer tube connection

94. Outer tube thread guide

95. Reinforcing rib

Valve fixation structure:

700. first sleeve barrel

403. Middle pipe connector

51. Middle pipe inserting section

52. Third cylindrical fixing block

53. Middle pipe connecting sealing cover

55. Rib plate

404. Third spacing post

Regurgitation heart valve:

10. valve support

20. Positioning piece

2001. Pull wire composite ring

Detailed Description

As described in the background, a regurgitation stent used in transcatheter aortic replacement is typically inserted into the sinus floor of the native aortic valve by three positioning members prior to release of the regurgitation stent, and after complete release of the regurgitation stent, the positioning members, along with the rest of the regurgitation stent, secure the regurgitation stent by the native aortic valve and the aortic wall. The existing positioning piece of the reverse flow bracket is opened by a certain angle by virtue of self elasticity, or the positioning piece is incompletely released, so that the problem that the positioning piece is difficult to insert into the sinus bottom because the diameter of a circle where three positioning pieces are positioned is smaller than the diameter of an aortic valve ring in clinical application exists. Based on the fact that the applicant integrates a plurality of locating piece adjusting structures on the handle of the conveyor, the opening angles of the locating pieces are respectively controlled through the locating piece adjusting structures, the technical problem which is primarily solved by the invention is solved, and in addition, other problems which occur clinically are properly improved, and the invention is specifically stated later.

Description of terms in this application: "distal" and "proximal" are used as terms of orientation which are conventional in the art of interventional medical devices, wherein "distal" refers to the end of the delivery system that is distal to the operator during a procedure and "proximal" refers to the end of the delivery system that is proximal to the operator during a procedure. "axial" refers to a direction parallel to the line connecting the distal center and the proximal center of the conveyor; "radial" refers to a direction perpendicular to the "axial" direction described above. "connected end" in this application generally refers to the connection of one component to another component, and "free end" in this application generally refers to the free state of one component at its end and not connected to other components. "distal" refers to the end of the delivery system that is distal to the apex of the heart during surgery and "proximal" refers to the end of the delivery system that is proximal to the apex of the heart during surgery. In addition, regurgitant heart valves include valve stents and valves (prosthetic or biological) connected to the valve stents. The regurgitant heart valves, valve bodies and heart valves described in the examples herein are synonymous. The outer sheath of the present application is also commonly referred to in the art as a center tube or elbow.

In addition, the known techniques typically associated with heart valve repair are not elaborated, but may be understood by one of ordinary skill in the art in view of the conventional manner in the art. Further advantages and effects of the present application will be readily apparent to those skilled in the art from the present disclosure, by describing the embodiments of the present application with specific examples.

Please refer to fig. 1-28. It should be understood that the structures, proportions, sizes, etc. shown in the drawings are shown only in connection with the present disclosure, and are therefore not intended to limit the scope of the invention, which is defined by the claims, but are not to be limited to the specific details disclosed herein.

The regurgitation heart valve transporter of the present invention is mainly used in aortic valve regurgitation, so for convenience of understanding, the operation process will be briefly described taking application to aortic regurgitation as an example, specifically, referring to fig. 1 and 2a, the regurgitation heart valve is illustrated at the distal end of the heart valve transporter, and for simplicity and clarity of expressing the connection relationship between the valve and the transporter, the valve leaflets and the coating of the valve are omitted, and only the stent of the valve is shown. The regurgitant heart valve comprises a valve holder 10 and a positioning member 20 with a distal end in a free state and a proximal end fixed to the valve holder 10.

The retrograde heart valve transporter of the present invention is directed from the distal end to the proximal end, referring to fig. 1, and the components disposed outside the handle housing 40 in turn comprise: a distal release knob 600, a first sleeve 700, a proximal release knob 500, a connection knob 400, a valve advancement knob 300, a center adjustment knob 200, and a second sleeve 100. Functionally, the distal release knob 600 is used to control the movement of its corresponding connection structure within the handle housing 40 to release the distal end of the regurgitant heart valve and the proximal release knob 500 is used to control the movement of its corresponding connection structure within the handle housing 40 to release the proximal end of the regurgitant heart valve. The distal release knob 600 and the proximal release knob 500 are connected by a first sleeve 700. Valve advancement knob 300 is used to control the movement of its corresponding attachment structure within handle housing 40 to advance the valve. The central adjustment knob 200 is used to control its corresponding action of the connection structure within the handle housing 40 to adjust the regurgitant heart valve to the central axis of the aorta. The distal end of the second sleeve 100 is adapted to receive a spacer adjustment mechanism for adjusting the opening angle of the spacer 20 of the reverse flow stent. In addition, after the heart valve at its distal end is delivered into the aorta by the delivery device, the valve holder needs to be rotated to align the positioning member 20 axially with the sinus floor of the native aortic valve, and the operation of the rotating valve holder needs to be completed by rotating the structure connected with the valve holder, which includes the distal release knob 600 and the connecting structure in the corresponding handle housing 40, the proximal release knob 500 and the connecting structure in the corresponding handle housing 40, and the first sleeve 700 and the internal structure thereof.

As above, the handle 6 can be divided into a valve control part 611 and a valve release part 612 from the distal end to the proximal end, and the valve control part 611 and the valve release part 612 can be connected together by plugging or turning, or can be used for independently controlling the reflux heart valve to axially move or rotate by withdrawing the plugging or turning. Specifically, an interface connection portion 613 (the membrane pushing knob 300 and its connection structure) is further provided between the valve control portion 611 and the valve release portion 612, and the valve control portion 611 and the valve release portion 612 are moved toward or away from each other by the interface connection portion 613. In addition, the interfacing connection 613 may further include a connection knob 400 and a connection structure thereof, the rotational connection between the valve control portion 611 and the valve release portion 612 being controlled by the connection knob 400, and the approaching or separating of the valve control portion 611 and the valve release portion 612 from each other being achieved by the membrane pushing knob 300. In general, when the membrane pushing knob 300 is operated, the valve control portion 611 and the valve releasing portion 612 are locked by the connecting knob 400, so that the valve control portion 611 and the valve releasing portion 612 act synchronously to avoid relative rotation; the valve control portion 611 and the valve release portion 612 are relatively movable by controlling the connection knob 400, for example, rotation of the valve release portion 612 about the axial center axis of the carrier.

Functionally, the valve control portion 611 is used to control the opening angle of the positioner 20 (the control wire knob 60, the second sleeve 100 and their internal connection structures) and the centering of the valve (the center adjusting knob 200 and its internal connection structures). The valve release portion 612 primarily controls the position of the valve body (first sleeve 700 and its internal connections), as well as the distal release of the valve (distal release knob 600 and its internal connections) and the proximal release (proximal release knob 500 and its internal connections). The interface connection 613 controls the connection or relative movement of the valve control portion 611 and the valve release portion 612 (valve advancement knob 300, connection knob 400, and connection structure thereof).

Based on the brief functional description above, with continued reference to fig. 1, the workflow of the regurgitant heart valve transporter is further described: 1) Compression loading the regurgitant heart valve to the distal end of the delivery device and ballasting the valve with the corresponding components; 2) The left femoral artery conveys the reverse blood flow of the conveyor to the descending aorta and passes through the aortic arch and then enters the ascending aorta; 3) The rotary valve release portion 612 is controlled by the connecting knob 400, and the heart valve is driven to rotate by matching with external developing equipment so that the positioning piece 20 is aligned with the sinus bottom; 4) After entering the ascending aorta, the heart valve is adjusted to the central axis of the ascending aorta by adjusting the center adjusting knob 200, so that the centrality of the heart valve is ensured; (wherein step 3) and step 4) may be performed in an alternating sequence or alternatively; 5) The valve release part 612 is controlled to approach the valve control part 611, the valve pushing knob 300 is rotated to drive the valve release part 612 to be integrally conveyed in the body, at the moment, the positioning stay wire is locked, the valve moves towards the proximal end, the positioning piece 20 is naturally opened by a larger angle, the heart valve is conveyed to the sinus bottom of the aortic valve, the positioning stay wire 90 is loosened, and the positioning piece 20 is put down; meanwhile, according to the image data, the angle of the positioning piece 20 is adjusted at any time through the wire control knob 60, if the positioning piece 20 fails to enter the sinus, the positioning piece 20 can be adjusted again through the positioning stay wire 90, so that the free end of the positioning piece 20 is opened to be higher than the edge of the native valve leaflet, and the positioning piece 20 can capture the native valve leaflet again under the condition that the valve does not retreat; 6) Rotating the distal release knob 600 releases the distal heart valve; 7) Rotating the proximal release knob 500 releases the proximal end of the heart valve; 8) And exiting the conveyor. The invention correspondingly improves the steps, and the most important improvement point is that the opening angle of the positioning piece is controlled in the step 5) to finish the accurate and smooth sinus bottom entering. The technical solutions of the present application will be clearly and completely described below with reference to the accompanying drawings and specific embodiments.

Example 1

Taking aortic valve regurgitation as an example, referring to fig. 1, the regurgitation heart valve transporter of this example includes a transporter handle 6 for transporting a regurgitation heart valve, a distal end of the transporter handle 6 is used for fixing the regurgitation heart valve, the regurgitation heart valve includes a plurality of positioning members 20, the transporter handle 6 includes a plurality of positioning member adjusting structures, and each positioning member adjusting structure is used for adjusting an opening angle of each positioning member 20. Because of the anatomy of the sinus floor of the aortic valve, the number of positioning elements of the regurgitant heart valve is generally three, and thus in the following examples, three positioning elements are taken as examples, and the number of positioning element adjustment structures is the same as the number of positioning elements 20. The purpose of each positioning member adjustment structure is to adjust the opening angle of each positioning member 20, respectively. When the positioning member 20 is faced with the problem that the angle of the self-expansion is insufficient, or the problem that the heart valve is still unable to smoothly enter the three sinus bottoms of the aortic valve after the positioning member 20 is expanded by continuously pushing the heart valve to the proximal end due to the fact that the self-expansion angle is not enough, or the problem that the position of the positioning wire 90 is controlled to be fixed, the heart valve is required to be retracted and readjusted, and the adjustment is difficult. Therefore, the positioning pieces 20 are respectively controlled through the positioning piece adjusting structures, so that the positioning pieces 20 can be independently adjusted in the body, the heart valve does not need to be readjusted after being retreated due to unreasonable release of the positioning pieces 20, and the positioning pieces 20 independently adjusted through the positioning piece adjusting structures can more accurately enter the sinus bottom of the aortic valve.

In one embodiment, referring to fig. 1, the delivery handle 6 includes a handle housing 40, a valve delivery tube assembly coupled to the handle housing 40, and a sheath tube assembly disposed within the handle housing 40, as shown in fig. 1, with a portion of the valve delivery tube assembly and the sheath tube assembly being located within the handle housing 40 and another portion exposed outside the handle housing 40 for intra-operative access.

Referring to fig. 4, 5 and 9, the outer sheath tube assembly includes an outer sheath tube 5 sleeved outside the valve delivery assembly, and the outer sheath tube 5 is provided with a plurality of positioning stay wire channels 501. Referring to fig. 1, the positioning member adjusting structure includes a plurality of positioning wires 90 and a wire control knob 60, wherein the wire control knob 60 is disposed on the handle housing 40. The regurgitant heart valve is fixed at the distal end of the valve delivery tube assembly, one side end of the positioning wire 90 is connected with the free end of the positioning member 20, and the other side end sequentially passes through the positioning wire channel 501 and the handle housing 40 and then is connected with the control wire knob 60. Specifically, the number of the control wire knobs 60 is three, and each control wire knob 60 controls a positioning wire 90 which is folded back and arranged in the positioning wire channel 501. Referring to fig. 2a and 9-11a, a wire hole is formed at the free end of the positioning member 20, and one end of the positioning wire 90 is connected to the wire control knob 60, and then sequentially passes through the positioning wire channel 501 and the wire hole, and then sequentially passes through the positioning wire channel 501 and the handle housing 40, and then is connected to the wire control knob 60. The positioning stay wire 90 arranged in the folded manner still penetrates out of the same positioning stay wire channel 501 after being folded, in this case, if the positioning stay wire 90 is a relatively thin common stay wire, the positioning stay wire 90 is easy to be mutually wound in the positioning stay wire channel 501, and is not easy to be drawn out, or the opening angle of the positioning piece 20 is not easy to be adjusted through the positioning stay wire 90. Thus, in a preferred embodiment, referring to fig. 1 and 10, the sheath 5 is provided with a plurality of sets of positioning stay channels 501, the number of sets of positioning stay channels 501 is the same as that of the positioning member adjusting structures, each set of positioning stay channels 501 includes a stay wire removing channel and a stay wire returning channel, the positioning stay wire 90 includes a stay wire removing channel and a stay wire returning channel which are integrally connected and are respectively arranged on the stay wire removing channel and the stay wire returning channel, the connection part of the stay wire removing channel and the stay wire returning channel is connected with the positioning member 20, the free ends of the stay wire removing channel and the stay wire returning channel are connected with the wire control knob 60, that is, the number of the positioning stay wire channels 501 is twice that of the positioning member 20, that is, each positioning stay wire 90 is in a returning state and occupies two positioning stay wire channels 501. For another example, the positioning wire 90 is a wire that forms a closed loop, and after adjustment is completed, the wire is cut from the proximal end of the positioning wire 90 and withdrawn from the body.

In one embodiment, referring to FIGS. 1, 13-17, the control knob 60 includes a control nut 604 including a press sleeve 607, a control washer 602, and a control bolt 601 including a stepped bore 606. The control wire knob 60 is provided with a through hole, and the through hole is used for passing through the positioning stay wire 90 and can be used as an evacuation port of the outer sheath tube. The through hole penetrates the control wire nut 604, the control wire gasket 602 and the control wire bolt 601. In the assembled state, the control wire bolt 601 is in threaded connection with the control wire nut 604, the control wire gasket 602 is located in the stepped hole 606, and the pressing sleeve 607 abuts against the upper end of the control wire gasket 602. The extrusion force of the control wire washer 602 on the positioning pull wire 90 is adjusted by controlling the screwing distance between the control wire nut 604 and the control wire bolt 601.

Specifically, referring to fig. 14, 15 and 17, the control nut 604 has a double sleeve structure that is sleeved with each other, and includes a pressing sleeve 607 and a threaded sleeve 608. The control wire bolt 601 is of a hollow structure, and a stepped hole 606 is formed in the control wire bolt. More specifically, the control line bolt 601 sequentially includes a bolt portion, a stop ring 609 and an insertion portion from top to bottom, the control line nut 604 is further provided with a threaded sleeve 608, the bolt portion is screwed with the threaded sleeve 608, and the stop ring 609 is used as a screwing end point. That is, the outer periphery of the upper portion of the control wire bolt 601 is provided with an external thread, the threaded sleeve 608 is provided with an internal thread, the control wire bolt 601 and the threaded sleeve 608 are in threaded connection through the external thread and the internal thread, and when in connection, the pressing sleeve 607 presses the control wire gasket 602 towards the direction of the stepped hole 602, so that the control wire gasket 602 tightens the positioning stay wire 90 positioned therein, and the tightening force or the locking force of the control wire gasket 602 on the positioning stay wire 90 is controlled through the tightening degree of the internal thread and the external thread. The purpose of setting the stop ring 609 is to avoid excessive extrusion of the control wire gasket caused by the screw connection of the control wire bolt 601 and the threaded sleeve 608, even damage to the control wire knob 60, and the inner wall of the threaded sleeve 608 is provided with a limit groove, and the stop ring 609 can be abutted with the limit groove to limit the axial movement distance of the control wire bolt 601 and the threaded sleeve 608.

Regarding the preferred arrangement of the control line pad 602:

a1: the material of the control wire gasket 602 is an elastic material, and has deformation characteristics, so that the extrusion of the control wire gasket 602 to the positioning stay wire 90 can be realized by controlling the screwing distance between the control wire nut 604 and the control wire bolt 601.

A2: the control wire gasket 602 is in a hollow cylinder structure and comprises a middle ring and two end rings positioned on two sides of the middle ring, wherein the outer diameter of the middle ring is smaller than the outer diameters of the two end parts. I.e., when the control wire washer 602 is compressed, its middle ring is radially drawn toward its center to tighten the positioning wire 90 located therein.

In a preferred embodiment, referring to fig. 14, 15 and 16, the control wire knob 60 further includes a control wire sealing ring 603, where the control wire sealing ring 603 is located in the control wire gasket 602 and faces a side of the control wire nut 604, and the control wire sealing ring 603 is a hollow inverted boss structure, which serves to assist in fixing the pull wire and sealing. Specifically, the upper portion of the wire seal ring 603 is flush with the upper portion of the wire washer 602, and the lower portion of the wire washer 602 abuts against the stepped hole 606.

The specific structure of the components of the control line knob 60 in this example also includes the following: 1) Referring to fig. 11, the direction of the symmetry axis of the control knob 60 is perpendicular to the direction of the central axis of the conveyor, so that the user can conveniently control the conveyor. 2) Referring to fig. 15, the through hole of the control wire nut 604 extends outwards to form a hollow cylindrical wire outlet 605 for connecting an external syringe, and the air in the outer sheath tube is replaced by normal saline or the like to realize the evacuation of the outer sheath tube, so that one component integrates a plurality of functions, the number of components of the conveyor is obviously reduced, and the operation is simpler.

In a preferred embodiment, referring to fig. 1, 11a, 11b and 12, the positioning member adjusting structure further includes a positioning wire fixing member 70, wherein the positioning wire fixing member 70 is disposed on the handle housing 40, and the positioning wire 90 is connected to the wire control knob 60 and then connected to the positioning wire fixing member 70. The excess positioning wires extending from the wire control knob 60 are looped around the positioning wire fixture 70. For another example, one end of the positioning wire 90 sequentially passes through the connection holes of the wire control knob 60 and the positioning member 20 from the outside of the conveyor, then turns back to the wire control knob 60 side and passes out from the through hole of the wire control knob 60, the redundant positioning wire is looped around the positioning wire fixing member 70, and the other end is connected with the wire control knob 60. The wire control knob 60 is used for adjusting the length of the positioning stay wire 90 and fixing the positioning stay wire 90, and the positioning stay wire fixing member 70 is used for further folding, adjusting the length of the positioning stay wire 90 and further fixing the redundant positioning stay wire 90 led out by the wire control knob 60. In this example, it is further preferable that the lower portion of the positioning wire fixing member 70 is a pin, an outer diameter of the pin is matched with an inner diameter of the through-hole of the wire control knob 60 and/or the wire outlet 605, and the pin of the positioning wire fixing member 70 is configured to be inserted into the wire control knob 60. If the wire control knob 60 cannot separately fix the positioning wire 90 due to too great a pulling force of the positioning member during the operation, the pin portion of the positioning wire fixing member 70 may be inserted into the wire control knob 60 to strengthen the fixation of the positioning wire 90.

In a specific example, as shown in fig. 3, 11a, 11b and 12, the outer sheath tube assembly further includes an outer sheath tube fixing member 412 fixedly disposed in the handle housing, the outer sheath tube fixing member 412 includes an outer sheath tube inserting hole 201 penetrating through the outer sheath tube fixing member 412 and a wire drawing and evacuating connection port 203, the outer sheath tube inserting hole 201 is used for inserting the outer sheath tube 5, and the penetrating hole of the wire control knob 60 is communicated with the evacuating connection port 203. Specifically, referring to fig. 11a and 11b, the outer sheath mount 412 further includes a sealing plate 204 and a sealing ring 205 disposed at a proximal end of the outer sheath mount 412. The periphery of the outer sheath tube inserting hole 201 is provided with a reinforcing rib 202.

Referring to fig. 3, 6, 11a, 12 and 13, the outer sheath fixing member 412 is disposed at the distal end of the conveyor handle 6, and the outer sheath fixing member 412 serves to limit the axial movement of the outer sheath 5 to maintain a relatively stationary state with the second handle housing 42, so that the outer circumferential surface of the outer sheath fixing member 412 is provided with a fixing hole 413 or a protruding member, and the inner surface of the second handle housing 42 is provided with a protruding member or a fixing hole engaged with the fixing hole 413 or the protruding member, and is engaged with or inserted into the handle housing 40 through the fixing hole 413 to define the axial position of the center tube.

Specifically, referring to fig. 11b, along the direction from the proximal end to the distal end, the sheath fixing member 412 includes a sheath insertion hole 201, a pull wire extraction and evacuation connection port 203, a plugging plate 204 and a sealing ring 205, and the control wire knob 60 and the positioning pull wire fixing member 70 are inserted into the outer periphery of the sheath fixing member 412. The outer periphery of the outer sheath tube inserting hole 201 is provided with a reinforcing rib 202 for increasing the strength of the connecting piece, so that a longer connecting piece can be arranged, the contact area and the contact length of the connecting piece and a corresponding tube are increased, and the axial stability of the outer sheath tube is improved. The central parts of the stay wire leading-out and exhausting connecting port 203 and the control wire knob 60 are hollow channels, are communicated with the stay wire leading-out and exhausting connecting port 203 to form an outlet channel for positioning stay wires, and the positioning stay wires passing through the positioning piece at the far end penetrate through the channels on the side wall of the outer sheath tube to the stay wire leading-out and exhausting connecting port 203, enter the outlet channel for positioning stay wires and are led out from the upper part of the control wire nut.

It should be noted that the above control of the positioning member by the control wire knob 60 and the like can be applied to the conveyor in the prior art, and in other specific examples, the internal structure of the conveyor and other improvements are given to implement the working steps 1) to 8) of the conveyor as described above.

In one embodiment, the valve delivery tube assembly comprises an inner tube, a middle tube, and an outer tube that are sequentially sleeved, the proximal end of the regurgitant heart valve is captured between the middle tube and the outer tube, the distal end is captured between the middle tube and the inner tube, and the connecting end of the positioning member 20 is proximal to the proximal end of the regurgitant heart valve and the free end is proximal to the distal end of the regurgitant heart valve. In particular, referring to fig. 1, 5 and 8, the inner tube includes an inner tube 1 and a front loading head sheath 11 at the distal end of the inner tube 1. The outer tube comprises an outer tube 3 and a rear loading sheath 31 at the distal end of the outer tube 3. The middle tube member comprises a middle tube 2, the middle tube 2 being provided with a first stepped groove 21, a valve carrier 22 and a second stepped groove 23, from the distal end of the middle tube 2 in the proximal direction. Wherein the front loading head sheath 11 cooperates with the first stepped slot 21 to form a front loading compartment and the rear loading sheath 31 cooperates with the second stepped slot 23 to form a rear loading compartment. The regurgitant heart valve is in a compressed state, and the distal end of the heart valve is loaded in the front loading chamber, the proximal end of the heart valve is loaded in the rear loading chamber, and the heart valve can release self-expansion from the two loading chambers when the inner tube 1 and the middle tube 2, and the middle tube 2 and the outer tube 3 are displaced. While the above release action relies on a connection structure provided inside the handle 6 of the delivery device, in particular the valve delivery tube assembly further comprises a distal release structure connected to the inner tube, a valve fixation structure connected to the middle tube and a proximal release structure connected to the outer tube. The middle pipe fitting is fixed relative to the handle shell, the inner pipe fitting and the outer pipe fitting can be displaced relative to the middle pipe fitting, namely, the valve fixing structure is fixedly connected with the handle shell 40, the distal end release mechanism is slidably connected with the handle shell 40 and used for driving the inner pipe fitting to move along the axial direction of the handle shell 40, and the proximal end release mechanism is slidably connected with the handle shell 40 and used for driving the outer pipe fitting to move along the axial direction of the handle shell 40. As above it is achieved that the inner tube 1 is remote from the middle tube 2 for releasing the distal end of the heart valve in the front loading chamber and the outer tube 3 is remote from the middle tube 2 for releasing the proximal end of the heart aid in the rear loading chamber. Specifically, specific examples of the distal release structure, the proximal release structure, and the valve fixation structure are given as follows:

B1, distal release structure corresponds to distal release knob 600 shown in FIG. 1, the action of the distal release structure is controlled by rotating distal release knob 600. Specifically, referring to fig. 3, 18 and 20, the distal release structure includes an inner tube connector 402, an inner tube thread guide 84 provided on the inner tube connector 402, and a distal release knob 600 screwed with the inner tube thread guide 84. The handle housing 40 is provided with an inner tube moving guide groove, the inner tube connector 402 is provided in the handle housing 40 (specifically in the first handle housing 41), and the inner tube screw guide 84 is movably provided in the inner tube moving guide groove, and an inner tube is connected to the inner tube connector 402.

Specifically, referring to fig. 18 and 20, the inner pipe connector 402 includes a hollow inner pipe insertion section 81 and a first cylindrical fixing block 82, the outer circumference of the first cylindrical fixing block 82 is matched with the inner circumference of the handle housing 40, and the inner pipe is inserted into the inner pipe insertion section 81. The arrangement of the first cylindrical fixing block 82 can enable the first cylindrical fixing block 82 and the handle shell 40 to be mutually attached to increase the contact area between the first cylindrical fixing block and the handle shell 40, when the cylindrical fixing block 82 moves axially along the handle shell 40, the movement is more stable, shaking cannot occur, and the valve control precision is improved. The design of the inner tube plugging section 81 can correspondingly prolong the contact area and the contact length of the inner tube connector 402 and the inner tube 1, improve the centrality of the inner tube 1, and reduce the risk that the valve cannot be released due to bending or even bending of the inner tube 1 in the axial movement process of the inner tube 1.

More specifically, referring to fig. 18 and 20, the outer circumference of the first cylindrical fixing block 82 is provided with a screw guide 84, and the screw guide 84 is screw-coupled with the distal release knob 600 through the inner tube moving guide groove. In use, the inner tube 1 is fixedly connected with the first cylindrical fixing block 82, and the distal release knob 600 is rotated to drive the inner tube 1 to move axially and distally, so that the distal end of the inner tube 1 is separated from the proximal end of the heart valve to release the proximal end of the heart valve. A reinforcing tube (not shown) is arranged between the cylindrical fixing block 82 and the inner tube 1, and is fixedly connected with the inner tube 1 through the reinforcing tube, so that the inner tube 1 is prevented from being damaged when the cylindrical fixing block 82 and the inner tube 1 move.

More specifically, referring to fig. 18, a first limiting post 414 is disposed in the handle housing 40 and located at the distal end of the inner tube moving guide slot for limiting the moving end of the inner tube connector 402, that is, a first limiting post 414 is disposed near the distal end of the inner tube connector 402, and the first limiting post 414 and the handle housing 40 together form a moving space of the inner tube connector 402, so as to limit the axial moving distance of the inner tube 1. That is, the stability of the movement of the inner tube is ensured by the inner tube movement guide groove and the first limit post 414.

In addition, the proximal end of the inner tube connector 402 is provided with an inner tube evacuation tube 401 for injecting physiological saline to discharge air in the inner tube, specifically, a through hole is provided in the middle of the inner tube connector 402, the distal end of the inner tube evacuation tube 401 passes through the through hole and communicates with the inner tube 1 inside the cylindrical fixing block 82, and when the conveyor is operated, physiological saline or the like is injected into the inner tube evacuation tube 401 to discharge air in the inner tube, for example, the inner tube evacuation tube 401 is externally connected with a luer connector, and can communicate with an external syringe or other injection device through the luer connector.

B2, proximal release structure corresponds to proximal release knob 500 shown in fig. 1, and the action of the proximal release structure is controlled by rotating proximal release knob 500. In particular, referring to fig. 3 and 19, the proximal release structure includes an outer tube connector 405, an outer tube thread guide 94 provided on the outer tube connector 405, and a proximal release knob 500 threaded with the outer tube thread guide 94. The handle housing 40 is provided with an outer tube movement guide groove, the outer tube connector is provided in the handle housing 40, and the outer tube screw guide 94 is movably provided in the outer tube movement guide groove.

Specifically, the proximal release structure is substantially the same as the distal release structure, referring to fig. 3 and 19, the outer tube connector 405 includes a hollow outer tube insertion section 91 and a second cylindrical fixing block 92, the outer circumference of the second cylindrical fixing block 92 is matched with the inner circumference of the handle housing 40, the outer tube is inserted into the outer tube insertion section 91, the outer circumference of the second cylindrical fixing block 92 is provided with an outer tube thread guide 94, and the outer tube thread guide 94 is threaded with the proximal release knob 500 through an outer tube movement guide groove. The arrangement of the second cylindrical fixing block 92 can enable the second cylindrical fixing block 92 and the handle shell 40 to be mutually attached to increase the contact area between the second cylindrical fixing block and the handle shell 40, so that when the second cylindrical fixing block 92 moves axially along the handle shell 40, the second cylindrical fixing block moves more stably, the shaking condition can not occur, and the accuracy of valve control is improved. The design of the outer tube plugging section 91 can correspondingly prolong the contact area and the contact length of the outer tube connector 405 and the outer tube 3, improve the centrality of the outer tube 3, and reduce the risk that the valve cannot be released due to bending or even bending of the inner tube during the axial movement of the outer tube 31.

Referring to fig. 19, the outer tube inserting section 91 is externally provided with a reinforcing rib 95, the reinforcing rib 95 gradually increases from the distal end to the proximal end along the radial direction until being connected to the inner side wall of the second cylindrical fixing block 92, more specifically, referring to fig. 19, the outer tube connector 405 further comprises an outer tube connecting sealing cover 93, the outer tube inserting section 91 and the outer tube connecting sealing cover 93 are respectively connected to the distal end and the proximal end of the second cylindrical fixing block 92, and the outer tube connecting sealing cover 93 plays a good sealing role.

It should be noted that the proximal release structure is substantially identical to the distal release structure, and the specific structures of the proximal release structure and the distal release structure may be referred to each other.

B3, the valve-securing structure includes a first sleeve 700 corresponding to that shown in fig. 1, the valve-securing structure being held relatively stationary with respect to the handle housing 40 at all times to precisely control the delivery and release positions of the valve. Specifically, referring to fig. 18, 20 and 21, the valve fixing structure includes a middle tube connector 403 fixedly disposed in the handle housing 40, the middle tube connector 403 is kept relatively stationary with the handle housing 40 all the time in the process of delivering the valve, the middle tube connector 403 includes a hollow middle tube inserting section 51 and a third cylindrical fixing block 52, the outer periphery of the third cylindrical fixing block 52 is matched with the inner periphery of the handle housing 40, the contact area with the handle housing 40 is increased, the stability of the delivery device is improved, and the middle tube is inserted into the middle tube inserting section 51.

More specifically, referring to fig. 21, the middle tube connector 403 further includes a middle tube connecting sealing cover 53, and the middle tube inserting section 51 and the middle tube connecting sealing cover 53 are respectively connected to the distal end and the proximal end of the third cylindrical fixing block 52, and the middle tube connecting sealing cover 53 performs a good sealing function.

As shown in fig. 20, the middle tube plugging section 51 has a certain length, so that the contact area and the contact length between the middle tube connector 403 and the middle tube 2 can be correspondingly prolonged, and the position of the middle tube 2 relative to the handle housing 40 (the first handle housing 41) is kept unique and stable, so that the following structural arrangement beneficial to stability is made:

specifically, referring to fig. 21, the third cylindrical fixing block 52 is provided with at least one insertion hole 54, and the inside of the handle housing 40 is provided with a plug which is engaged with the insertion hole 54, and the plug is inserted into the insertion hole 54 to limit the axial position of the middle tube connector 403 so as to be kept relatively stationary with the handle housing 40.

More specifically, referring to fig. 21, the outer periphery of the middle tube insertion section 51 is provided with radial ribs 55, and one end of the ribs 55 is connected to the third cylindrical fixing block 52. The radial ribs 55 serve a further fixing function.

Further, referring to fig. 20, a middle outer tube drain 701 (or may be used as a middle inner tube drain) may be provided on the middle tube connector 403. The through hole is arranged between the middle pipe and the outer pipe, or the communicated pipe is arranged between the outer pipe and the middle pipe, or the through hole is arranged between the middle pipe and the inner pipe, and the through hole is selected according to actual needs.

In one embodiment, the conveyor handle further includes a centering structure, corresponding to the centering knob 200 shown in fig. 1 or 3, for controlling the action of the outer sheath by rotating the centering knob 200 to accomplish: after entering the ascending aorta, the heart valve is adjusted to the central axis of the ascending aorta by adjusting the center adjusting knob 200, so that the centrality of the heart valve is ensured. Specifically, referring to fig. 12 and 22, the centering structure includes at least one centering wire 410, a centering sleeve 409 with internal threads, and a threaded slider 907 in threaded connection with the centering sleeve 409, wherein rotation of the centering sleeve 409 is used to drive the threaded slider 907 to move along the axial direction of the centering sleeve, and the centering sleeve 409 is fixedly connected with the center adjusting knob 200. Referring to fig. 9 and 22, the proximal end of the centering wire 410 is provided on the threaded slider 907, and the distal end of the centering wire 410 is connected to the outer sheath 5 as the threaded slider 907 moves axially, and the centering wire 410 is initially in a natural tension state, and the bending degree of the outer sheath 5 is adjusted by pulling the centering wire 410. In particular, the inner side wall of the centering sleeve 409 is provided with an axial guide along which the threaded slider 907 moves directly, except in this way the system stability is relatively low. Preferably, referring to fig. 22, the centering structure further comprises a guide cylinder 906 secured within the handle housing 40, with the guide cylinder 906 being located outside the valve delivery tube assembly and a threaded slider 907 being movably sleeved outside the guide cylinder 906. The guide cylinder 906 is provided with a guide bar, the threaded slider 907 is provided with a guide groove matched with the guide bar, or the guide bar and the guide groove are exchanged, and the purpose of guiding and moving along the axial direction is mainly achieved. The guide cylinder 906 is used for bearing the threaded slider 907 and limiting the stay wire 410. In the use process, the center adjusting knob 200 is rotated to drive the center adjusting sleeve 409 to rotate circumferentially, the center adjusting sleeve 409 drives the threaded slide block 907 to move axially, and the valve stent is driven to move from the edge of the main artery to the central axis of the main artery by adjusting the curvature of the distal end of the outer sheath 5, so that the center adjusting step of the heart valve is completed.

More specifically, referring to fig. 12, 22 and 23, the centering structure further includes a fixed disk 904 disposed at the distal end of the guide cylinder 906, the fixed disk 904 being provided with an anti-rotation tab, the handle housing 40 (second handle housing 42) being provided with a fixed connection block having a fixed hole, the anti-rotation tab being inserted into the fixed hole to prevent circumferential and/or axial movement of the guide cylinder 906.

In the preferred example of the above embodiment, referring to fig. 23, the centering structure further includes a center slider 908 movably sleeved outside the guide cylinder 906, and the center slider 908 is disposed at the proximal end side of the threaded slider 907, and the proximal end of the centering wire 410 is connected to the center slider 908 after passing through the threaded slider 907. The centering sleeve 409 drives the threaded slider 907 to axially move and move towards the distal end, meanwhile, the threaded slider 907 drives the central slider 908 to move towards the distal end, so as to continuously tighten the centering wire 410, so as to adjust the curvature of the distal end of the outer sheath 5, and when the outer sheath is required or is bent and withdrawn in the adjusting process, the centering sleeve 409 drives the threaded slider 907 to axially move and move towards the proximal end, at this time, the central slider 908 is not subjected to force towards the proximal end any more, the outer sheath 5 automatically straightens under the action of elastic force, at this time, the centering stay wire 410 generates force for pulling the central slider 908 to move towards the proximal end, and the central slider 908 does not force the centering stay wire 410 to move towards the proximal end, so that the following reasons are set: if the central slider 908 is forced to push towards the distal end, the central pull wire is easy to bend, and the distal end of the sheath tube is easy to forcibly straighten back in the human body, which causes damage to the blood vessel.

Specifically, referring to fig. 11a and 11b, the outer sheath fixing member 412 is provided with a pull wire channel 912, the proximal end of the centering pull wire 410 is provided with a threaded slider 907, and the distal end is connected to the outer sheath 5 after passing through the pull wire channel 912.

In the preferred embodiment of the embodiment, referring to fig. 10, the outer sheath 5 is further provided with at least one centering pull wire cavity 502, the centering pull wire 410 is disposed through the centering pull wire cavity 502 and the distal end is connected to the outer sheath, it should be noted that, the number of the centering pull wires 410 is set according to the bending requirement of the outer sheath 5, generally 1 to 3, and if 1 centering pull wire 410 is disposed, the centering pull wire 410 is fixedly disposed at the distal end of the outer sheath 5.

Specifically, referring to fig. 10, the centering wire 410 is in a sheet structure, the cross section of the centering wire cavity 502 is rectangular, the centering wire 410 is limited to move in the centering wire cavity 502, the rectangular cross section increases the contact area between the centering wire 410 and the centering wire cavity 502, and the centering wire 410 is prevented from being damaged and embedded into the centering wire cavity 502 after being pulled.

In a specific example, referring to fig. 1, the conveyor handle 6 comprises a valve control portion 611 and a valve release portion 612, the valve delivery tube assembly being connected to the valve release portion 612, the outer sheath 5 being connected to the valve control portion 611. The delivery or rotation of the valve is accomplished by controlling the synchronous movement or separate individual rotation of the connection of the valve control portion 611 and the valve release portion 612. Referring to fig. 1, 3 and 24, the valve pushing structure corresponds to the valve pushing knob 300 shown in fig. 1 or 3, and the valve pushing knob 300 is rotated to integrally push the valve releasing portion to move proximally, so as to complete the integral internal delivery of the valve releasing portion 612, and the heart valve is delivered to the sinus bottom of the aortic valve. Specifically, referring to fig. 3 and 24, the valve advancing structure includes a valve advancing knob 300, a valve advancing sleeve 408 is provided with an advancing screw guide 420, a handle housing 40 (second handle housing 42) is provided with an advancing axial guide groove, the advancing screw guide 420 is movably provided in the advancing axial guide groove, and the advancing screw guide 420 is screwed with the valve advancing knob 300.

More specifically, referring to fig. 3, which is a partial structural state diagram of the handle 6 before the heart valve is pushed, the distal end periphery of the valve pushing sleeve 408 is provided with a pushing thread guide 420, the second handle housing 42 is provided with a pushing axial guide groove matched with the pushing thread guide 420, the pushing thread guide 420 is threaded with the valve pushing knob 300 through the pushing axial guide groove, the outer periphery of the second handle housing 42 and the first handle housing 41 is further provided with an axial limiting piece 803 (referring to fig. 18) to limit the axial movement of the valve pushing knob 300, and the valve pushing sleeve 408 and the valve releasing part are driven to move distally by rotating the valve pushing knob 300 to convey the distal heart valve to the sinus bottom of the native aortic valve.

More specifically, referring to fig. 3, 4 and 24, the valve advancement structure further comprises a coupling knob 400, and a coupling gear 407 is provided at the proximal end of the valve advancement sleeve 408. Valve pushing sleeve 408 is located at the interface of valve control portion 611 and valve release portion 612, and handle housing 40 at valve release portion 612 is provided with a threaded bore. The connecting knob 400 is screwed and passes through the threaded hole to be in clamping connection with the connecting gear 407. Specifically, a connecting gear 407 is provided at the proximal end of the valve pushing sleeve 408 to which the valve pushing knob 300 is adapted, and the handle housing 40 of the valve releasing portion limits the connecting gear 407 inside to ensure the consistency of the axial movement of the valve control portion 611 and the valve releasing portion 612, and rotating the valve pushing knob 300 drives the valve pushing sleeve 408 and the valve releasing portion to move distally. After the heart valve at its distal end is delivered into the aorta by the delivery device, the stent needs to be rotated to align the positioning member axially with the sinus floor of the native aortic valve, at this time, the connection knob 400 should be rotated to disengage the connection knob 400 from the connection gear 407, then the handle housing 40 (first handle housing 41) of the valve release portion 612 portion is rotated, and after the position of the positioning member 20 is rotated to be proper, the connection knob 400 is rotated reversely, so that the bolts of the connection knob 400 are inserted between the adjacent teeth of the connection gear 407, to keep the valve control portion 611 and the valve release portion 612 in synchronization and to avoid the relative rotation.

In a preferred embodiment, referring to fig. 1 and 3, the delivery device further comprises a stiffening sleeve 406, the stiffening sleeve 406 being connected at a distal end to the valve pushing sleeve 408 and at a proximal end to the handle housing. Specifically, the distal end of the reinforcing sleeve 406 is nested within the valve pushing sleeve 408, and the proximal end snaps into the handle housing (first handle housing 41) for reinforcement against breaking the valve release portion 612.

The method of using the conveyor is briefly described: 1) Compression loading the regurgitant heart valve to the distal end of the delivery device and ballasting the valve with the corresponding components; 2) The left femoral artery conveys the reverse blood flow of the conveyor to the descending aorta and passes through the aortic arch and then enters the ascending aorta; 3) The rotary valve release portion 612 is controlled by the connecting knob 400, and the heart valve is driven to rotate by matching with external developing equipment so that the positioning piece 20 is aligned with the sinus bottom; 4) After entering the ascending aorta, the heart valve is adjusted to the central axis of the ascending aorta by adjusting the center adjusting knob 200, so that the centrality of the heart valve is ensured; 5) The valve release part 612 is controlled to approach the valve control part 611, the valve pushing knob 300 is rotated to drive the valve release part 612 to be integrally conveyed in the body, at the moment, the positioning stay wire is locked, the valve moves towards the proximal end, the positioning piece is naturally opened by a larger angle, the heart valve is conveyed to the sinus bottom of the aortic valve, the positioning stay wire is loosened, and the positioning piece is put down; meanwhile, according to the image data, the angle of the positioning piece 20 is adjusted at any time through the wire control knob 60, if the positioning piece fails to enter the sinus, the positioning piece 20 can be adjusted again through the positioning stay wire, so that the free end of the positioning piece 20 is opened to be higher than the edge of the native valve leaflet, and the positioning piece 20 can capture the native valve leaflet again under the condition that the valve does not retreat; 6) Rotating the distal release knob 600 releases the distal heart valve; 7) Rotating the proximal release knob 500 releases the proximal end of the heart valve; 8) And exiting the conveyor.

Example 2

Referring to fig. 1, 2 and 25-28, a precisely positioned regurgitant heart valve delivery system includes a regurgitant heart valve and a regurgitant heart valve delivery device, the regurgitant heart valve including a valve holder 10 and a valve coupled to the valve holder, the valve holder 10 including a plurality of positioning members 20. Specifically, the free end of the positioning member 20 is provided with a pull wire composite ring 2001, and the pull wire hole is formed in the pull wire composite ring 2001, preferably, the pull wire composite ring 2001 is made of a developing material. Specifically, the distal end of the conventional positioning member is provided with a marker (the marker is radiopaque), and although the positioning implantation of the stent is facilitated to a certain extent by the arrangement of the marker, the risk of falling off the marker exists. If the "marker" falls off and enters other organs along with the blood flow, the safety of the user is seriously affected. The pull wire composite ring 2001 of the present embodiment eliminates the "marker" mounting hole, but the pull wire composite ring 2001 itself is provided with a developing function, thereby increasing the safety of the user. An X-ray impermeable marking layer may be provided on the surface of the connection plate of the pull-wire composite ring 2001 or a high density metal plating layer may be added on the surface of the connection plate, so that the pull-wire composite ring 2001 may be more clear under X-rays.

Preferably, the pull wire composite ring 2001 is of a regular or irregular geometry, i.e. the outer profile of the web of the pull wire composite ring 2001 may be configured as one or more of a gourd shape, a triangle shape, a circle shape, a diamond shape, or a cat-foot shape. The pull wire composite ring 2001 has a specific shape, so that an operator can quickly identify the pull wire composite ring 2001, thereby replacing the mark "marker".

The embodiments are described above in order to facilitate the understanding and application of the present application by those of ordinary skill in the art. It will be apparent to those skilled in the art that various modifications can be made to these embodiments and that the general principles described herein may be applied to other embodiments without the use of inventive faculty. Accordingly, the present application is not limited to the embodiments herein, and those skilled in the art, based on the present disclosure, may make improvements and modifications without departing from the scope and spirit of the present application.

Claims

1. A positioning-accurate regurgitant heart valve transporter comprising a transporter handle (6) for transporting a regurgitant heart valve, the distal end of the transporter handle for securing the regurgitant heart valve, the regurgitant heart valve comprising a number of positioning members (20);

The conveyer handle is characterized by comprising a plurality of positioning piece adjusting structures, wherein each positioning piece adjusting structure is used for adjusting the opening angle of each positioning piece (20).

2. The regurgitant heart valve transporter of claim 1, wherein the transporter handle (6) comprises a handle housing (40), a valve delivery tube assembly connected to the handle housing (40), and an outer sheath assembly disposed within the handle housing (40);

the outer sheath tube assembly comprises an outer sheath tube (5) sleeved outside the valve conveying assembly, and the outer sheath tube (5) is provided with a plurality of positioning stay wire channels (501);

the positioning piece adjusting structure comprises a plurality of positioning stay wires (90) and a wire control knob (60), and the wire control knob (60) is arranged on the handle shell (40);

the reverse flow heart valve is fixed at the far end of the valve conveying pipe assembly, one side end of the positioning stay wire (90) is connected with the free end of the positioning piece (20), and the other side end sequentially penetrates through the positioning stay wire channel (501) and the handle shell (40) and then is connected with the control wire knob (60).

3. The regurgitant heart valve transporter of claim 2, comprising at least one of the following technical features:

a) The positioning stay wire (90) is arranged in the positioning stay wire channel (501) in a turning-back state;

b) A wire pulling hole is formed in the free end of the positioning piece (20), and one end of the positioning wire (90) is connected with the wire control knob (60), sequentially penetrates through the positioning wire pulling channel (501) and the wire pulling hole, sequentially penetrates through the positioning wire pulling channel (501) and the handle shell (40) and then is connected with the wire control knob (60);

c) The control line knob (60) comprises a control line screw cap (604) comprising a pressing sleeve (607), a control line gasket (602) and a control line bolt (601) comprising a stepped hole (606);

the control wire knob (60) is provided with a through hole, the through hole penetrates through the control wire nut (604), the control wire gasket (602) and the control wire bolt (601), and the positioning stay wire (90) penetrates through the through hole;

in the assembled state, the control line bolt (601) is in threaded connection with the control line nut (604), the control line gasket (602) is positioned in the stepped hole (606), and the pressing sleeve (607) presses the upper end of the control line gasket (602); adjusting the extrusion force of the control wire gasket (602) on the positioning stay wire (90) through controlling the screwing distance between the control wire nut (604) and the control wire bolt (601);

d) The positioning piece adjusting structure further comprises a positioning stay wire fixing piece (70), wherein the positioning stay wire fixing piece (70) is arranged on the handle shell (40), and the positioning stay wire (90) is connected with the control wire knob (60) and then connected with the positioning stay wire fixing piece (70);

e) The valve delivery tube assembly comprises an inner tube, a middle tube and an outer tube which are sleeved in sequence, the proximal end of the regurgitation heart valve is restrained between the middle tube and the outer tube, the distal end is restrained between the middle tube and the inner tube, the connecting end of the positioning piece (20) is close to the proximal end of the regurgitation heart valve, and the free end is close to the distal end of the regurgitation heart valve;

f) The conveyor handle further comprises a centering structure, wherein the centering structure comprises at least one centering stay wire (410), a centering sleeve (409) with internal threads and a threaded slider (907) in threaded connection with the centering sleeve (409), and the rotation of the centering sleeve (409) is used for driving the threaded slider (907) to move along the axial direction of the centering sleeve; the proximal end of the centering stay wire (410) is arranged on the threaded slider (907), and the distal end is connected with the outer sheath tube (5);

g) The conveyor handle (6) comprises a valve control part (611) and a valve release part (612), the valve conveying pipe is connected to the valve release part (612), and the outer sheath pipe (5) is connected to the valve control part (611);

the conveyor handle (6) also comprises a valve pushing structure for driving the valve conveying pipe assembly to axially move along the conveyor handle; the valve advancement structure comprises a valve advancement sleeve (408) slidably disposed within the handle housing (40), the valve advancement sleeve (408) being connected to the valve release portion (612);

h) The conveyor handle (6) further comprises an evacuation structure in communication with the valve delivery tube assembly for evacuating air from the valve delivery tube assembly;

i) The outer sheath pipe assembly further comprises an outer sheath pipe fixing part (412) fixedly arranged in the handle shell, the outer sheath pipe fixing part (412) comprises an outer sheath pipe inserting hole (201) and an emptying connecting port (203) which penetrate through the outer sheath pipe fixing part (412), the outer sheath pipe inserting hole (201) is inserted into the outer sheath pipe (5), and the penetrating through hole of the control wire knob (60) is communicated with the emptying connecting port (203).

4. A regurgitation heart valve transporter according to claim 3, characterized in that in technical features a) and/or b), the outer sheath (5) is provided with several sets of positioning pull wire channels (501), the number of sets of positioning pull wire channels (501) being the same as the number of positioning member adjustment structures, each set of positioning pull wire channels (501) comprising a wire-out channel and a wire-back channel;

the positioning stay wire (90) comprises a stay wire removing passage and a stay wire returning passage which are integrally connected, the stay wire removing passage and the stay wire returning passage are respectively arranged, the connecting part of the stay wire removing passage and the stay wire returning passage is connected with the positioning piece (20), and the free ends of the stay wire removing passage and the stay wire returning passage are connected with the wire control knob (60).

5. A regurgitation heart valve transporter according to claim 3, comprising technical features f) and i), further comprising, that the outer sheath fixation element (412) is provided with a pull wire channel (912), the proximal end of the centering pull wire (410) is provided with the threaded slider (907), and the distal end is connected to the outer sheath (5) after passing through the pull wire channel (912).

6. The regurgitant heart valve transporter of claim 3, comprising at least one of the following technical features:

c1 The through hole of the control wire nut (604) extends outwards to form a hollow cylindrical stay wire outlet (605) for connecting an external syringe;

c2 The control line knob further comprises a control line sealing ring (603), the control line sealing ring (603) is positioned in the control line gasket (602) and faces one side of the control line nut (604), and the control line sealing ring (603) is of a hollow inverted boss structure;

c3 The control wire gasket (602) comprises a middle ring and two end rings positioned at two sides of the middle ring, wherein the outer diameter of the middle ring is smaller than that of the two end rings;

c4 The material of the control wire gasket (602) is an elastic material;

c5 The control line bolt (601) sequentially comprises a bolt part, a stop ring (609) and an insertion part from top to bottom; the control line nut (604) is further provided with a threaded sleeve (608), the bolt part is in threaded connection with the threaded sleeve (608), and the stop ring (609) is used as a threaded connection terminal point;

d1 The lower part of the positioning stay wire fixing piece (70) is provided with a pin column, and the outer diameter of the pin column is matched with the inner diameter of the through hole of the control wire knob (60);

e1 The inner tube comprises an inner tube (1) and a front loading head sheath (11) positioned at the distal end of the inner tube (1); the outer tube comprises an outer tube (3) and a rear loading sheath (31) at the distal end of the outer tube (3); the middle pipe fitting comprises a middle pipe (2), the middle pipe (2) is provided with a first step groove (21), a valve bearing part (22) and a second step groove (23) from the distal end of the middle pipe (2) to the proximal end; the front loading head sheath (11) is matched with the first step groove (21) to form a front loading bin, and the rear loading sheath (31) is matched with the second step groove (23) to form a rear loading bin;

e2 The valve delivery tube assembly further comprises a distal release structure connected to the inner tube, a valve fixation structure connected to the middle tube, and a proximal release structure connected to the outer tube;

the valve fixing structure is fixedly connected with the handle shell (40); the distal release mechanism is slidably connected with the handle housing (40) and is used for driving the inner pipe to move along the axial direction of the handle housing (40); the proximal release mechanism is slidably connected with the handle shell (40) and is used for driving the outer pipe to move along the axial direction of the handle shell (40);

f1 The centering structure further comprises a guide cylinder (906) fixed in the handle shell (40), the guide cylinder (906) is positioned outside the valve conveying pipe assembly, and the thread sliding block (907) is movably sleeved outside the guide cylinder (906);

g1 The valve pushing structure further comprises a valve pushing knob (300), the valve pushing sleeve (408) is provided with a pushing thread guide member (420), the handle shell (40) is provided with a pushing axial guide groove, the pushing thread guide member (420) is movably arranged in the pushing axial guide groove, and the pushing thread guide member (420) is in threaded connection with the valve pushing knob (300);

i1 The outer sheath pipe fixing piece (412) further comprises a plugging plate (204) and a sealing ring (205) which are arranged at the proximal end of the outer sheath pipe fixing piece (412);

i2 The periphery of the sheath tube inserting hole (201) is provided with a reinforcing rib (202).

7. The regurgitation heart valve transporter of claim 6, further comprising at least one of the following technical features:

e21 The distal end release structure comprises an inner pipe connector (402), an inner pipe thread guide (84) arranged on the inner pipe connector (402) and a distal end release knob (600) in threaded connection with the inner pipe thread guide (84); the handle shell (40) is provided with an inner pipe moving guide groove, the inner pipe connector (402) is arranged in the handle shell (40), the inner pipe threaded guide piece (84) is movably arranged in the inner pipe moving guide groove, and the inner pipe piece is connected with the inner pipe connector (402);

e22 The proximal release structure comprises an outer tube connector, an outer tube thread guide piece arranged on the outer tube connector and a proximal release knob (500) in threaded connection with the outer tube thread guide piece; the handle shell (40) is provided with an outer tube moving guide groove, the outer tube connector is arranged in the handle shell (40), and the outer tube thread guide piece is movably arranged in the outer tube moving guide groove;

e23 The valve fixing structure comprises a middle pipe connector (403) fixedly arranged in the handle shell (40), the middle pipe connector (403) comprises a hollow middle pipe inserting section (51) and a third cylindrical fixing block (52), the periphery of the third cylindrical fixing block (52) is matched with the inner periphery of the handle shell (40), and the middle pipe fitting is inserted into the middle pipe inserting section (51);

f11 The sheath tube (5) is also provided with at least one centering stay wire cavity (502), and the centering stay wire (410) is arranged in the centering stay wire cavity (502) in a penetrating way and the far end of the centering stay wire cavity is connected with the sheath tube (5);

f12 The centering structure further comprises a fixed disc (904) arranged at the far end of the guide cylinder (906), the fixed disc (904) is provided with an anti-rotation lug, the handle shell (40) is provided with a fixed connecting block with a fixed hole, and the anti-rotation lug is spliced with the fixed hole;

f13 The periphery of the guide cylinder (906) is provided with a guide strip, and the thread slider (907) is provided with a guide groove matched with the guide strip;

g11 The valve pushing structure further comprises a connecting knob (400), and a connecting gear (407) is arranged at the proximal end of the valve pushing sleeve (408);

the valve pushing sleeve (408) is positioned at the junction of the valve control part (611) and the valve releasing part (612), and a handle shell (40) positioned at the valve releasing part (612) is provided with a threaded hole; the connecting knob (400) is in threaded connection and is in clamping connection with the connecting gear (407) after passing through the threaded hole.

8. The regurgitant heart valve transporter of claim 7, comprising at least one of the following technical features:

e211 The inner pipe connector (402) comprises a hollow inner pipe inserting section (81) and a first cylindrical fixing block (82), the outer periphery of the first cylindrical fixing block (82) is matched with the inner periphery of the handle shell (40), and the inner pipe is inserted into the inner pipe inserting section (81);

e213 A first limit column (414) is arranged in the handle shell (40), is positioned at the far end of the inner tube moving guide groove and is used for limiting the moving end point of the inner tube connector (402);

e231 The third cylindrical fixed block (52) is provided with at least one jack (54), and the inner side of the handle shell (40) is provided with a plug post matched with the jack (54);

e232 The periphery of the middle pipe inserting section (51) is provided with radial rib plates (55), and one end of each rib plate (55) is connected with a third cylindrical fixed block (52);

f111 The center-adjusting stay wire (410) is of a sheet-shaped structure, and the cross section of the center-adjusting stay wire cavity (502) is of a rectangular structure;

f121 The centering structure further comprises a center slide block (908) movably sleeved outside the guide cylinder (906), the center slide block (908) is arranged on the proximal end side of the threaded slide block (907), and the proximal end of the centering stay wire (410) penetrates through the threaded slide block (907) and then is connected with the center slide block (908).

9. A precisely positioned regurgitant heart valve delivery system comprising a regurgitant heart valve and a regurgitant heart valve delivery system according to any one of claims 1-8; the regurgitant heart valve comprises a valve holder (10) and a valve connected with the valve holder, the valve holder (10) comprising a number of positioning elements (20).

10. The heart valve delivery system of claim 9, wherein a free end of the positioning member (20) is provided with a pull wire compound ring (2001), the pull wire hole being provided in the pull wire compound ring (2001); preferably, the material of the stay wire composite ring (2001) is a developing material; and/or the pull wire composite ring (2001) is of regular or irregular geometry.