CN222566033U

CN222566033U - Reverse flow heart valve conveyor and conveying system with stable operation

Info

Publication number: CN222566033U
Application number: CN202322605481.6U
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: 2025-03-07
Anticipated expiration: 2033-09-25
Also published as: CN116849870A; CN116849871A; WO2023184639A1; CN117752467A; CN115624416B; CN116849869A; CN115105259B; CN218356472U; CN116807685A; CN115381598A; CN117752467B; CN219000725U; CN116807686A; CN117752468B; CN115381597A; CN219332099U; CN115105259A; CN218356470U; CN117752468A; CN219000720U

Abstract

The present application provides a regurgitant heart valve delivery device and delivery system with stable operation, belonging to the field of medical device technology. The delivery device includes a delivery device handle, and the delivery device handle includes a handle housing, a valve delivery tube assembly connected to the handle housing, and an outer sheath tube assembly arranged in the handle housing. The delivery device handle includes a valve control part and a valve release part, the valve delivery tube assembly is connected to the valve release part, and the outer sheath tube is connected to the valve control part. The delivery device handle also includes a valve propulsion structure arranged between the valve control part and the valve release part. The valve propulsion structure includes a valve propulsion sleeve slidably arranged in the handle housing, which is used to make the valve release part approach or move away from the valve control part. The present application drives the valve release part to approach or move away from the valve control part through the valve propulsion structure between the valve control part and the valve release part, and the propulsion process is stable.

Description

Reverse flow heart valve conveyor and conveying system with stable operation

Technical Field

The application relates to the technical field of medical equipment for heart valve repair, in particular to a reflux heart valve conveyor and a conveying system with stable operation.

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. When the positioning piece is released, the heart valve is controlled to rotate through a centering (bending) component of the conveyor so that the positioning piece is aligned to the sinus bottom, at the moment, the centering (bending) component is kept still, and the valve is driven to move towards the proximal end through an internal pipe fitting system of the conveyor so that the positioning piece is inserted into the sinus bottom. This procedure requires high operational stability, and it is therefore desirable to provide a regurgitant heart valve transporter that is stable in operation to ensure accuracy and stability of operation.

Disclosure of utility model

In view of the above-described problems of the prior art, a primary object of the present application is to provide a regurgitation heart valve transporter and a delivery system that are stable in operation, with the positioning member being stabilized in sinus access by the cooperative arrangement of the structures.

To achieve the above and other related objects, a first aspect of the present application provides an operationally stable regurgitation heart valve transporter, comprising a transporter handle including a handle housing, a valve delivery tube assembly connected to the handle housing, and a sheath tube assembly disposed within the handle housing;

the conveyor handle also comprises a valve pushing structure arranged between the valve control part and the valve releasing part, wherein the valve pushing structure comprises a valve pushing sleeve which is arranged in the handle shell in a sliding manner and is used for enabling the valve releasing part to be close to or far away from the valve control part.

In an embodiment of the first aspect, the valve pushing structure further comprises a valve pushing knob, a pushing thread guide is provided at a distal end of the valve pushing sleeve, the handle housing is provided with a pushing axial guide groove, the pushing thread guide is movably provided in the pushing axial guide groove, and the pushing thread guide is screwed with the valve pushing knob.

In an embodiment of the first aspect, the handle housing comprises a first housing and a second housing that are movable towards and away from each other, the valve control portion being located in the second housing and the valve release portion being located in the first housing;

the pushing axial guide groove is arranged on the second shell, and the proximal end of the valve pushing sleeve is detachably connected with the first shell.

In an embodiment of the first aspect, the valve advancement structure further comprises a connection knob, a connection gear being provided at the proximal end of the valve advancement sleeve;

The first shell is provided with a threaded hole, and the connecting knob is connected with the connecting gear in a clamping mode after being screwed into the threaded hole.

In one possible embodiment of the first aspect, the valve delivery tube assembly comprises an inner tube, a middle tube and an outer tube, which are sequentially sleeved, the proximal end of the regurgitant heart valve being captured between the middle tube and the outer tube, the distal end being captured between the middle tube and the inner tube.

The inner tube comprises an inner tube and a front loading head sheath positioned at the distal end of the inner tube, the outer tube comprises an outer tube and a rear loading sheath positioned at the distal end of the outer tube, the middle tube comprises a middle tube, a first stepped groove, a valve bearing part and a second stepped groove are formed in the middle tube in the direction from the distal end of the middle tube 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 far-end releasing structure is slidably connected with the handle shell and used for driving the inner pipe to move along the axial direction of the handle shell, and the near-end releasing structure is slidably connected with the handle shell and used for driving the outer pipe to move along the axial direction of the handle shell.

And 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 thread guide piece is movably arranged in the inner pipe moving guide groove, and the inner pipe piece is connected with the inner pipe connector.

And 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 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.

And as a preferable 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.

And 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 as a preferable scheme, radial rib plates are arranged on the periphery of the middle pipe inserting section, and one end of each rib plate (55) is connected with the third cylindrical fixed block.

A second aspect of the application provides an operationally stable regurgitant heart valve delivery system comprising a regurgitant heart valve and a reduced-emptying regurgitant heart valve delivery device as described above.

In one possible implementation manner of the second aspect, the free end of the positioning piece is provided with a pull wire composite ring, the pull wire hole is formed in the pull wire composite ring, preferably, the pull wire composite ring is made of a developing material, and/or the pull wire composite ring is regular or irregular geometric shape.

The present application provides a stable operation regurgitation heart valve transporter and system with, but not limited to, the following benefits:

1) The valve pushing structure between the valve control part and the valve releasing part drives the valve releasing part to approach or separate from the valve control part, so that the pushing process is stable.

2) The valve pushing sleeve is provided with a pushing thread guide part at the far end, the thread guide part is movably arranged in a pushing axial guide groove of the handle shell, and is in threaded connection with the valve pushing knob, and the pushing process of driving the valve releasing part to approach or separate from the valve control part is more stable in a threaded connection pushing mode.

3) The proximal end of the valve pushing sleeve is detachably connected with the first shell, so that the valve control part and the valve releasing part keep synchronous action and relative rotation is avoided when the valve pushing sleeve is connected.

Drawings

Fig. 1 is a schematic view showing the structure of a valve control portion and a valve release portion of a conveyor according to embodiment 1 of the present application in a remote state.

Fig. 2 shows a cross-sectional view of fig. 1.

Fig. 3 is an enlarged view of a portion a in fig. 2.

Fig. 4 is a schematic cross-sectional view showing the structure of the valve control portion and the valve releasing portion in a closed state.

Fig. 5 shows an enlarged view of the portion B in fig. 4.

Fig. 6 shows a state diagram of a heart valve (only a valve stent is shown) according to the present application, wherein a1 is an initial state after a positioning member is released, a2 is a state that the heart valve moves to a proximal end to open a certain angle when a positioning wire and a free end of a fixing member are kept motionless, and a3 is a state that the heart valve is self-expanded and released after the positional relationship between an inner tube and an outer tube and a middle tube is adjusted.

Fig. 7 shows a partial exploded view of the outer sheath assembly of the valve delivery tube assembly.

Fig. 8 shows a schematic view of the handle housing with a cut-away portion of the conveyor.

Fig. 9 shows an enlarged view of the proximal end of the fig. 6 conveyor.

Fig. 10 shows a schematic structure of the outer tube connector.

Fig. 11 is a schematic structural view of a middle tube connector.

Fig. 12 shows a heart valve (only a portion of the valve stent is shown) in which the pull wire composite ring is triangular.

Fig. 13 shows a heart valve (only a portion of the valve stent is shown) in which the pull wire composite ring is prismatic.

Fig. 14 shows a heart valve (only a portion of the valve stent is shown) in which the pull wire composite ring is circular.

Fig. 15 shows a heart valve (only a portion of the valve stent is shown) in which the pull wire composite ring is five-pointed star shaped.

Description of the reference numerals

6. Conveyor handle

40. Handle shell

41. First handle shell

42. Second handle shell

611. Valve control unit

612. Valve release

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

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

500. Proximal release knob

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:

403. Middle pipe connector

51. Middle pipe inserting section

52. Third cylindrical fixing block

53. Middle pipe connecting sealing cover

55. Rib plate

Regurgitation heart valve:

10. valve support

20. Positioning piece

2001. Pull wire composite ring

Detailed Description

As described in the background, the present application provides a regurgitant heart valve transporter that is stable in operation to ensure accuracy and stability of operation.

The terms "distal" and "proximal" are used herein 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 and proximal centers of the conveyor and "radial" refers to a direction perpendicular to the "axial" direction. "connecting end" in the present utility model generally refers to the connection of one component to another component, and "free end" in the present utility model generally refers to the free state of one component at one 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 regurgitation heart valves, valve bodies, valves and heart valves described in the embodiments of the present utility model are synonymous. In addition, the directions or positional relationships indicated by "upper", "lower", "inner", "outer", etc. are directions or positional relationships based on the drawings, are merely for convenience of description and simplification of description, and do not indicate or imply that the apparatus or elements referred to must have a specific direction, be constructed and operated in a specific direction, and thus are not to be construed as limiting the utility model. 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 utility model will become apparent to those skilled in the art from the disclosure of the present utility model, which is described by the following specific examples.

Please refer to fig. 1-15. It should be understood that the structures, proportions, sizes, etc. shown in the drawings are for illustration purposes only and should not be construed as limiting the application to the extent that it can be practiced, since modifications, changes in the proportions, or otherwise, used in the practice of the application, are not intended to be critical to the essential characteristics of the application, but are intended to fall within the spirit and scope of the application.

Example 1

Referring to fig. 1-11, the present embodiment provides a regurgitation heart valve transporter with stable operation, comprising a transporter handle 6, wherein the transporter handle 6 comprises a handle housing 40, a valve delivery tube assembly connected with the handle housing 40, and an outer sheath tube assembly arranged in the handle housing 40. 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 and the outer sheath 5 being connected to the valve control portion 611. The conveyor handle 6 further comprises a valve advancement structure provided between the valve control portion 611 and the valve release portion 612, the valve advancement structure comprising a valve advancement sleeve 408 slidably provided within the handle housing 40 for bringing the valve release portion 612 closer to or farther from the valve control portion 611. Specifically, the valve release portion 612 is integrally pushed to move toward the proximal end to complete the overall delivery of the valve release portion 612 into the body, thereby delivering the heart valve to the sinus floor of the aortic valve. Namely, a valve pushing structure between the valve control part 611 and the valve release part 612 is adopted to drive the valve release part 612 to be close to or far away from the valve control part 611, so that the pushing process is stable, the valve in-place pushing action is stable, and the damage to tissues is avoided.

In a preferred embodiment, referring to fig. 1, 3 and 8, the valve advancement structure further comprises a valve advancement knob 300, the distal end of the valve advancement sleeve 408 is provided with an advancement thread guide 420, the handle housing 40 is provided with an advancement axial guide groove 401, the advancement thread guide 420 is movably provided in the advancement axial guide groove, and the advancement thread guide 420 is threadedly engaged with the valve advancement knob 300. The valve pushing sleeve is provided with a pushing thread guide part at the far end, the thread guide part is movably arranged in a pushing axial guide groove of the handle shell, the pushing thread guide part is in threaded connection with the valve pushing knob, and the pushing process of driving the valve releasing part to approach or be far away from the valve control part is more stable in a threaded connection pushing mode.

In a preferred embodiment, referring to fig. 3 and 8, the handle housing includes a first housing 41 and a second housing 42 that are movable toward and away from each other, the valve control portion 611 is located within the second housing 42, and the valve release portion 612 is located within the first housing. A pusher axial guide slot is provided in the second housing 42, and the proximal end of the valve pusher sleeve 408 is controllably rotatably coupled to the first housing. The proximal end of the valve pushing sleeve is controllably rotatably coupled to the first housing to ensure that the valve control portion 611 and the valve release portion 612 remain in synchronous motion and avoid relative rotation when coupled.

In a specific embodiment, referring to fig. 3, 5 and 8, a controllable rotational connection of the proximal end of the valve pushing sleeve to the first housing is provided, the valve pushing structure further comprises a connection knob 400, a connection gear 407 is provided at the proximal end of the valve pushing sleeve 408, and the first housing is provided with a threaded hole. 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 first handle housing 41 of the handle housing 40 of the valve release portion 612 is rotated, and after the positioning member 20 is rotated to a proper position, the connection knob 400 is rotated in the opposite direction, 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 addition, referring to fig. 9, the outer circumferences of the second handle housing 42 and the first handle housing 41 are also provided with axial stoppers 803 to limit the axial movement of the valve pushing knob 300.

In a preferred 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 being captured between the middle tube and the outer tube, the distal end being captured between the middle tube and the inner tube. Specifically, the proximal end of the regurgitant heart valve is captured between the intermediate tube and the outer tube, the distal end is captured between the intermediate 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. 6 and 7, 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 structure 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 structure 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 possible to realise 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 that the outer tube 3 is remote from the middle tube 2 for releasing the proximal end of the heart valve 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. 1, 8 and 9, 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. 9, the inner pipe connector 402 includes a hollow inner pipe insertion section 81 and a first cylindrical fixing block 82, wherein the outer periphery of the first cylindrical fixing block 82 is matched with the inner periphery 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 during the axial movement of the inner tube 1.

More specifically, referring to fig. 9, 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 the cylindrical fixing block 82 and the inner tube 1 are fixedly connected with each other through the reinforcing tube, so that the inner tube 1 is prevented from being damaged due to movement of the cylindrical fixing block 82 and the inner tube 1.

More specifically, referring to fig. 9, 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, referring to fig. 9, an inner tube emptying tube 401 is provided at a proximal end of the inner tube connector 402 for injecting physiological saline to discharge air in the inner tube, specifically, a through hole is provided in a middle portion of the inner tube connector 402, a distal end of the inner tube emptying 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 is injected into the inner tube emptying tube 401 to discharge air in the inner tube, for example, the inner tube emptying 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. Referring to fig. 1, 8 and 10, in particular, 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 arranged in the handle housing 40, and the outer tube thread guide member is movably arranged in the outer tube movement guide groove.

Specifically, the proximal release structure is substantially the same as the distal release structure, and 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 moving 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. 10, 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. 10, 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, valve fixation structure package corresponds to the first sleeve 700 shown in FIG. 1, with the proximal release structure remaining relatively stationary with respect to the handle housing 40 at all times to precisely control the delivery and release position of the valve. Specifically, referring to fig. 8, 9 and 11, 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 still 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. 11, 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. 9, 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. 11, 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. 11, 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.

Example 2

Referring to fig. 6 and 12-15, a regurgitant heart valve delivery system with precise positioning includes a regurgitant heart valve and a regurgitant heart valve delivery device, the regurgitant heart valve includes a valve support 10 and a valve connected with the valve support, and the valve support 10 includes 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".

Briefly described is a method for using the above-mentioned delivery device, which comprises 1) compressing and loading a regurgitated heart valve to the distal end of the delivery device and ballasting and fixing the same by adopting corresponding components, 2) delivering the regurgitated blood flow of the delivery device from the left femoral artery to the descending aorta and passing through the aortic arch and then entering the ascending aorta, 3) controlling a rotary valve releasing part 612 through a connecting knob 400, driving the heart valve to rotate by matching with external developing equipment so that a positioning part 20 is aligned with the sinus floor, 4) adjusting a central adjusting knob 200 to adjust the heart valve to the central axis of the ascending aorta after entering the ascending aorta, ensuring the centrality of the heart valve, wherein the steps 3) and 4) are alternatively performed or alternately, 5) controlling the valve releasing part 612 to approach a valve control part 611, driving the valve releasing part 612 to integrally deliver the same to the inside of the body by a rotary valve pushing knob 300, capturing the native valve leaves of the positioning part 20, positioning the positioning part entering the sinus, placing the valve at the aortic valve, 7) rotating a distal releasing knob 600 to release the distal end of the heart valve, 8) rotating a proximal releasing the proximal end of the heart valve, and 9) withdrawing the delivery device.

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. Therefore, 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 within the scope and spirit of the present application without departing from the scope and spirit of the present application.

Claims

1. An operationally stable regurgitant heart valve transporter comprising a transporter handle (6), said transporter handle (6) comprising a handle housing (40), a valve delivery tube assembly connected to said handle housing (40) and an outer sheath assembly provided within said handle housing (40);

characterized in that the conveyor handle (6) comprises a valve control part (611) and a valve release part (612), the valve conveying pipe assembly 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) further comprises a valve pushing structure arranged between the valve control part (611) and the valve release part (612), wherein the valve pushing structure comprises a valve pushing sleeve (408) slidably arranged in the handle shell (40) and used for enabling the valve release part (612) to be close to or far away from the valve control part (611).

2. The regurgitant heart valve delivery device of claim 1 wherein the valve advancement structure further comprises a valve advancement knob (300), the distal end of the valve advancement sleeve (408) is provided with an advancement thread guide (420), the handle housing (40) is provided with an advancement axial guide groove (401), the advancement thread guide (420) is movably disposed in the advancement axial guide groove, and the advancement thread guide (420) is threadably engaged with the valve advancement knob (300).

3. The regurgitant heart valve transporter of claim 2, wherein the handle housing comprises a first housing (41) and a second housing (42) that are movable toward and away from each other, the valve control portion (611) being located within the second housing (42), the valve release portion (612) being located within the first housing;

The valve advancement sleeve (408) is rotatably coupled to the first housing (42) at a proximal end thereof.

4. A regurgitant heart valve carrier according to claim 3, wherein the valve advancing structure further comprises a connecting knob (400), a connecting gear (407) being provided at the proximal end of the valve advancing sleeve (408);

The first shell is provided with a threaded hole, and the connecting knob (400) is connected with the connecting gear (407) in a clamping mode after being screwed in and penetrating through the threaded hole.

5. The regurgitant heart valve delivery device of any of claims 1-2 or 4 wherein 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 being captured between the middle tube and the outer tube, and a distal end being captured between the middle tube and the inner tube.

6. The regurgitation heart valve transporter of claim 5, wherein the inner tube comprises an inner tube (1) and a front loading head sheath (11) located at the distal end of the inner tube (1), the outer tube comprises an outer tube (3) and a rear loading sheath (31) located at the distal end of the outer tube (3), the middle tube comprises a middle tube (2) in a proximal direction from the distal end of the middle tube (2), the middle tube (2) is provided with a first step groove (21), a valve bearing part (22) and a second step groove (23), the front loading head sheath (11) cooperates with the first step groove (21) to form a front loading chamber, and the rear loading sheath (31) cooperates with the second step groove (23) to form a rear loading chamber;

and/or 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 (40), the far-end release structure is slidably connected with the handle shell (40) and used for driving the inner pipe to move along the axial direction of the handle shell (40), and the near-end release structure is slidably connected with the handle shell (40) and used for driving the outer pipe to move along the axial direction of the handle shell (40).

7. The regurgitation heart valve transporter of claim 6, wherein the distal release structure comprises 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), wherein the handle housing (40) is provided with an inner tube movement guide groove, the inner tube connector (402) is provided in the handle housing (40), and the inner tube thread guide (84) is movably provided in the inner tube movement guide groove, the inner tube is connected with the inner tube connector (402);

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;

and/or, 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).

8. The regurgitant heart valve transporter of claim 7, wherein the inner tube connector (402) comprises a hollow inner tube 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 tube is inserted into the inner tube insertion section (81);

And/or, a first limit post (414) is arranged in the handle shell (40), is positioned at the far end of the inner pipe moving guide groove and is used for limiting the moving end point of the inner pipe connector (402);

and/or, 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);

And/or 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 the third cylindrical fixing block (52).

9. A regurgitant heart valve delivery system of stable operation comprising a regurgitant heart valve and a regurgitant heart valve delivery device according to any of claims 1-8, said regurgitant heart valve comprising a valve holder (10) and a valve connected to said valve holder, said valve holder (10) comprising a plurality of positioning members (20).

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

11. The heart valve delivery system of claim 10, wherein the pull wire composite ring (2001) is provided with a pull wire hole.