CN115517822A

CN115517822A - Transapical mitral valve replacement transporter

Info

Publication number: CN115517822A
Application number: CN202210548426.5A
Authority: CN
Inventors: 吴明明; 吴意; 王亮; 陈大凯
Original assignee: Koka Nantong Lifesciences Co Ltd
Current assignee: Koka Nantong Lifesciences Co Ltd
Priority date: 2022-05-20
Filing date: 2022-05-20
Publication date: 2022-12-27

Abstract

The invention discloses a trans-apical mitral valve replacement conveyor which is sequentially provided with a handle shell, a middle pipe, an inner pipe, a middle core pipe and a tether from outside to inside, wherein a forward push knob is arranged at the near end, the handle shell, a retraction knob, an outer pipe, a middle pipe far end, an inner pipe far section, a middle core pipe far section and a tether far section are respectively arranged at the far end from outside to inside, and the far section is respectively provided with the outer pipe, a transition connecting piece, a valve accommodating pipe, a sheath pipe sleeve and a valve contraction pipe arranged in the valve accommodating pipe which are sequentially connected from the near end to the far end. According to the invention, the front push knob is connected with the middle pipe in a buckling manner, so that the front push knob can stably rotate the middle pipe, and the middle pipe can stably move the inner pipe to push the valve bundle collecting pipe to convey towards the far end; the transition connecting piece prevents the inner tube from rotating and can linearly convey the artificial valve towards the far end in the conveying process; and the retraction knob is limited by arranging the groove in the square frame of the handle shell and is matched with the bulges on the two end surfaces of the retraction knob, so that the stability of the system in the retraction process is improved.

Description

Transapical mitral valve replacement transporter

Technical Field

The invention belongs to the technical field of medical equipment, and particularly relates to a transapical mitral valve replacement conveyor.

Background

Valvular heart disease, particularly the mitral valve, occurs in approximately 1000 million people each year in china because the mitral valve annulus is not a standard circle, but resembles a D-shape. Therefore, in order to satisfy the requirement of simultaneously adapting to the mitral annulus and not affecting the sealing performance of the artificial valve leaflets, a double-layer stent is currently researched, and in order to avoid the limitation of the transfemoral mode on the pressing and holding diameter and the defect of the traditional chest-opening mode on the human body, the mitral valve replacement is more performed through the transapical mode at present.

The CN107750150a patent application provides a device and method for delivering, repositioning and retrieving transcatheter prosthetic valves, but the delivery knob of the device risks idle delivery of the inner tube and system instability resulting in delivery failure.

Disclosure of Invention

The invention aims to solve the technical problems of idle running of inner tube conveying and conveying failure caused by unstable system of a conveying knob in the prior art, and aims to provide a novel trans-apical mitral valve replacement conveyor.

The present invention provides a transapical mitral valve replacement transporter, comprising:

a valve constricting pipe, the interior of which can be compressed to place the artificial valve;

a middle pipe, wherein the inner surface of the middle pipe is provided with a middle pipe internal thread;

the inner tube penetrates through the middle tube at the near section, the far end of the inner tube is abutted to the near end of the valve contraction tube, the outer surface of the near end of the inner tube is provided with inner tube external threads, the inner tube external threads are connected to the middle tube internal threads in a matched mode, and the rotation of the middle tube can drive the inner tube to push the valve contraction tube towards the far end;

the Niu Bika of the forward push knob is buckled and connected to the near-end pipe wall of the middle pipe, and the forward push knob is rotated circumferentially to drive the middle pipe to rotate.

The valve restraint tube is connected with the middle tube in a buckling mode through the forward push knob, so that the forward push knob can stably rotate the middle tube, the middle tube can stably move the inner tube, and the valve restraint tube can be pushed to convey towards the far end.

Preferably, the transapical mitral valve replacement transporter further comprises:

the handle shell is sleeved outside the middle pipe, and the forward push knob is rotatably arranged at the near end of the handle shell;

a transition piece located at the distal end of the handle shell, the distal section of the inner tube non-rotatably disposed through the transition piece.

The invention can linearly convey the artificial valve towards the far end by preventing the inner tube from rotating in the conveying process through the transition connecting piece.

Preferably, the first and second liquid crystal display panels are,

the inner wall of the far end of the forward push knob is provided with a plurality of annular convex rings;

the outer wall of the near end of the handle shell is provided with a plurality of corresponding annular concave rings, and the annular convex ring of the forward push knob is embedded in the annular concave ring of the handle shell, so that the forward push knob is rotatably arranged at the near end of the handle shell.

Preferably, the first and second liquid crystal display panels are,

the inner wall of the far end of the forward push knob is provided with a plurality of annular concave rings;

the outer wall of the near end of the handle shell is provided with a plurality of corresponding annular convex rings, and the annular convex rings of the handle shell are embedded in the annular concave rings of the forward push knob, so that the forward push knob is rotatably arranged at the near end of the handle shell.

Preferably, the first and second liquid crystal display panels are,

the front push knob is provided with a front push gasket which is clamped between the inner wall of the near end of the handle shell and the outer wall of the near end of the middle pipe so as to reduce friction between the handle shell and the middle pipe during rotation.

Preferably, the first and second liquid crystal display panels are,

the inner wall of the near end of the forward push knob is provided with at least one axial groove;

the outer wall of the near end of the middle pipe is provided with at least one axial clamping plate; the axial clamping plate of the middle pipe is embedded in the axial groove of the forward push knob, so that the forward push knob rotates circumferentially to drive the middle pipe to rotate.

Preferably, the first and second liquid crystal display panels are,

the inner wall of the near end of the forward push knob is provided with at least one axial clamping plate;

the near-end pipe wall of the middle pipe is provided with at least one axial groove; the axial clamping plate of the forward push knob is embedded in the axial groove of the middle pipe, so that the forward push knob rotates circumferentially to drive the middle pipe to rotate.

Preferably, the first and second liquid crystal display panels are,

the outer rings of the radial sections of the middle section and the far section of the inner pipe are non-circular;

the inner ring of the radial section of the transition connecting piece is a non-circular shape matched with the shape and size of the outer ring of the radial section of the middle section and the far section of the inner pipe, and the middle section far section of the inner pipe is arranged in the transition connecting piece in a penetrating mode and cannot rotate.

Preferably, the first and second liquid crystal display panels are,

the outer rings of the radial sections of the middle section and the far section of the inner pipe are D-shaped, square-shaped,

A shape, square or polygon;

the inner ring of the radial section of the transition connecting piece is D-shaped, square-shaped,

A shape, square, or polygon.

Preferably, the proximal section inner wall of the handle case has:

the plurality of proximal section axial reinforcing ribs are axially and fixedly arranged on the proximal section inner wall of the handle shell;

the plurality of proximal radial reinforcing ribs are radially and fixedly arranged on the proximal inner wall of the handle shell;

the near-segment axial reinforcing ribs and the near-segment radial reinforcing ribs can be attached to the outer wall of the middle pipe, so that the stability of the middle pipe during rotation is improved.

the valve containing tube is internally preset with the valve contraction tube, the distal end of the transition connecting piece is connected with the proximal end of the valve containing tube, the distal section of the inner tube is arranged in the proximal end of the valve containing tube in a penetrating manner, a cavity sealing gasket is arranged at the joint of the distal end of the transition connecting piece and the proximal end of the valve containing tube, and the cavity sealing gasket is sleeved on the periphery of the distal section of the inner tube;

a sheath sleeve having a sheath sealing gasket in a proximal end thereof, the proximal end of the sheath sleeve being sealingly connected to the distal end of the valve receiving tube, the middle tube being rotatable to drive the inner tube to push the valve restraining tube to deliver the prosthetic valve distally along a central axis of the sheath sleeve.

Preferably, the sheath sleeve has:

a sheath base at the proximal end of the sheath sleeve, the sheath base of the sheath sleeve being attached to the distal end of the valve containment tube;

the proximal end of the inner sheath tube is connected with the distal end of the sheath tube base;

and the outer sheath pipe is sleeved outside the inner sheath pipe, and the near end of the outer sheath pipe is connected with the far end of the sheath pipe base.

the outer pipe is arranged between the distal section of the handle shell and the distal end of the middle pipe, the outer surface of the outer pipe is provided with outer pipe external threads, and the proximal end of the transition connecting piece is fixedly connected to the distal end of the outer pipe;

and the withdrawing knob is clamped in the opening cavity of the distal section of the handle shell, the inner surface of the withdrawing knob is provided with knob inner threads, the knob inner threads are matched and connected with the outer pipe outer threads, and the withdrawing knob is rotated to drive the outer pipe, the valve containing pipe connected with the outer pipe and the sheath pipe sleeve to withdraw towards the near end so as to release the artificial valve.

the middle core pipe penetrates through the inner pipe, and the near end of the middle core pipe penetrates out of the near end of the forward push knob;

the inner surface of the near end of the inner tube is provided with a circle of near end fixing rings, and the near end of the middle core tube is attached to and penetrates through the near end fixing rings of the inner tube to provide supporting force for the middle core tube;

the utility model discloses a heart valve, including well core pipe, the outer wall of well core pipe's distal end outer wall cover is equipped with the solid fixed ring of distal end, the solid fixed ring's of distal end outer wall circumference is equipped with a rubber circle, the inner wall of inner tube compresses tightly the rubber circle of well core pipe distal end, in order to incite somebody to action prosthetic valve seals with the external world and keeps apart.

the far end of the locking head is movably connected with the near end of the forward push knob, the middle section of the locking head is provided with a locking knob with a sealing ring, the near end of the locking head is provided with a screw cap, and the near end of the core tube is fixed in the far end of the locking head;

and the tether is arranged in the central core tube in a penetrating way, the far end of the tether is connected with the artificial valve, and the near end of the tether penetrates out of the near end of the locking head and can be locked by the locking knob and/or the nut.

Preferably, the first and second liquid crystal display panels are,

the outer wall of the near end of the valve convergent tube is provided with an outer step opening;

the far-end inner wall of the inner tube is provided with an inner step opening, and the outer step opening of the valve bundling tube is matched and buckled on the inner step opening of the inner tube to form abutting joint.

Preferably, the transapical mitral valve replacement transporter comprises:

the two ends of the proximal connecting piece are respectively detachably connected with the transition connecting piece and the valve accommodating tube, and the transition connecting piece and the valve accommodating tube are connected together through the proximal connecting piece;

and the two ends of the distal connecting piece are detachably connected with the valve accommodating tube and the sheath sleeve respectively, and the valve accommodating tube and the sheath sleeve are connected together through the distal connecting piece.

Preferably, the first and second liquid crystal display panels are,

the valve constricting tube is internally provided with a trumpet-shaped structure, and the opening of the trumpet-shaped structure faces to the far end. When the artificial valve is pre-folded, the proximal end of the artificial valve is folded at the bell mouth structure, and the other part of the artificial valve is positioned in a larger space in the valve accommodating tube.

The invention also aims to solve the technical problem that in the process of withdrawing the sleeve, the withdrawing knob and the handle shell are not matched in cavity opening shape and can shake unstably during rotation, so that an outer pipe penetrating through the withdrawing knob, a valve accommodating pipe connected with the outer pipe and a sheath sleeve shake, and the invention aims to provide a novel technical scheme capable of stably withdrawing components such as the sheath sleeve and the like. The transcardiac mitral valve replacement conveyor in the technical scheme can stably withdraw components such as the sheath and the sleeve after the artificial valve is conveyed to a target position.

The present invention provides a transapical mitral valve replacement delivery device comprising:

the valve comprises an outer pipe, a valve accommodating pipe and a sheath pipe sleeve, wherein the outer pipe is provided with outer pipe external threads on the outer surface, and the valve accommodating pipe and the sheath pipe sleeve are sequentially connected from the near end to the far end;

a handle shell, wherein the far section of the handle shell is sleeved outside the outer pipe;

a retraction knob disposed in the open cavity of the distal section of the handle shell, the retraction knob having an inner knob thread on an inner surface thereof, the inner knob thread being connected to the outer tube thread, the retraction knob being rotated to cause the outer tube, the valve accommodating tube and the sheath tube connected to the outer tube to retract proximally to release the prosthetic valve;

wherein, the first and the second end of the pipe are connected with each other,

the open cavity of the handle shell is a square frame penetrating through the handle shell, and a circle of groove for clamping is arranged on the far-end frame wall and/or the near-end frame wall of the square frame;

the withdrawing knob is provided with a circle of clamping bulges on the side surface of the far end and/or the side surface of the near end, and the bulges of the withdrawing knob are embedded in the groove of the handle shell so as to limit the withdrawing knob.

According to the invention, the grooves for clamping are arranged in the frame of the handle shell, the corresponding bulges are arranged on the two end surfaces of the retraction knob, and the bulges of the retraction knob are embedded in the grooves of the handle shell, so that the retraction knob is limited, and the stability of the retraction knob in the retraction process and the stability of the valve accommodating tube and the sheath tube sleeve which are connected together by the outer tube and the outer tube which are arranged in the retraction knob in a penetrating manner in the retraction process are improved.

Preferably, the circle of protrusions for clamping is a plurality of protrusions which are uniformly distributed into a circle, and the protrusions are uniformly embedded in the grooves of the handle shell.

Preferably, the circle of protrusions for clamping is a circle of convex rings, and the convex rings are embedded in the grooves of the handle shell.

Preferably, the retraction knob has:

and the two withdrawing washers are arranged on the proximal end surface and the distal end surface of the withdrawing knob, are sleeved outside the outer pipe and are clamped in the bulges, and are used for reducing friction during rotation and improving the stability during rotation.

The width of the protrusion is smaller than that of the retraction washer, and the retraction knob is rotatably connected with the handle shell through the retraction washer.

Preferably, the retraction knob has:

the knob inner thread is arranged on the inner surface of the inner knob ring;

the outer button ring is sleeved outside the inner button ring;

the support ring is positioned between the inner button ring and the outer button ring and is used for fixedly connecting the inner button ring and the outer button ring, so that the outer diameter of the outer button ring can be enlarged and the outer button ring can be conveniently rotated under the condition of not increasing materials and weight.

Preferably, the first and second liquid crystal display panels are,

the outer wall of the near end of the outer pipe is provided with a plurality of guide plates which are axially arranged;

the inner wall of the handle shell is provided with a plurality of positioning plates which are axially arranged, and the guide plates can be clamped on the positioning plates, so that the outer tube can be retracted in a non-rotatable mode.

the valve constricting pipe can be internally compressed and used for placing the artificial valve, and can be pre-arranged in the valve accommodating pipe;

the middle pipe penetrates through the handle shell, and the inner surface of the middle pipe is provided with middle pipe internal threads;

the proximal section of the inner tube penetrates through the inner part of the middle tube, the distal section of the inner tube penetrates through the proximal end of the valve accommodating tube, the distal end of the inner tube is connected with the valve contraction tube, the outer surface of the proximal end of the inner tube is provided with inner tube external threads, the inner tube external threads are connected to the middle tube internal threads in a matched mode, and the middle tube can drive the inner tube to convey the artificial valve towards the distal end by rotating;

the proximal end of the transition connecting piece is fixedly connected to the distal end of the outer tube, the distal end of the transition connecting piece is connected with the proximal end of the valve accommodating tube, a cavity sealing washer is arranged at the joint of the distal end of the transition connecting piece and the proximal end of the valve accommodating tube, the cavity sealing washer is sleeved on the periphery of the distal section of the inner tube, the outer tube and the valve accommodating tube are connected together through the transition connecting piece, and the distal section of the inner tube is arranged in the transition connecting piece in a non-rotatable penetrating mode;

the front push knob is arranged at the near end of the handle shell, niu Bika of the front push knob is connected to the near-end pipe wall of the middle pipe in a buckled mode, and the front push knob is rotated circumferentially to drive the middle pipe to rotate.

the central core pipe penetrates through the inner pipe, and the near end of the central core pipe penetrates out of the near end of the forward push knob;

the inner surface of the near end of the inner tube is provided with a circle of near end fixing ring, and the near end of the middle core tube is attached to and penetrates through the near end fixing ring of the inner tube to provide supporting force for the middle core tube;

Preferably, the transapical mitral valve replacement transporter has:

and the two ends of the distal connecting piece are detachably connected with the valve accommodating pipe and the sheath sleeve respectively, and the valve accommodating pipe and the sheath sleeve are connected together through the distal connecting piece.

Preferably, the first and second liquid crystal display panels are,

the wall of the outer pipe penetrates through the pipe hole;

a shell hole penetrates through the far section of the handle shell, and the shell hole corresponds to the pipe hole in position;

scales are arranged on the outer wall of the inner tube, and the scales on the inner tube can be checked through the shell hole and the tube hole so as to judge the conveying position.

Preferably, the outer surface of the valve containing tube has an outer tube stiffener with an indicator.

Preferably, the sheath sleeve has:

the sheath tube base is positioned at the proximal end of the sheath tube sleeve and is provided with a sheath sealing gasket, and the distal end of the valve accommodating tube is hermetically connected in the sheath tube sleeve by the sheath sealing gasket;

The invention aims to solve the technical problems that in the prior art, the connection between an outer tube and a valve accommodating tube is unstable, and the valve accommodating tube is easy to fall off from the outer tube in the withdrawing process, and provides a technical scheme for stably connecting the outer tube and the valve accommodating tube. The present invention provides a transapical mitral valve replacement conveyor comprising:

an outer tube, the outer surface has outer tube external screw thread;

a retraction knob disposed within the open cavity of the distal section of the handle shell, the retraction knob having internal knob threads on an inner surface thereof, the internal knob threads being connected to the external outer tube threads;

the near end of the transition connecting piece is fixedly connected with the far end of the outer tube;

a valve accommodating tube, the proximal end of which is connected to the distal end of the transition piece;

a sheath sleeve attached to the distal end of the valve receiving tube;

rotating the retraction knob to retract the outer tube, the valve accommodating tube and the sheath tube connected together with the outer tube, proximally to release the prosthetic valve;

the far end of the outer pipe is a round pipe, and the outer wall of the round pipe is provided with a cutting hole for cutting a pair of walls;

the near end of the transition connecting piece is a flange pipe, the flange pipe penetrates through the outer pipe, a pair of through holes penetrating through the wall are formed in the positions, corresponding to the flange pipe, of the flange pipe, and a pair of fixing rods penetrate through the through holes of the transition connecting piece and the cut holes of the outer pipe respectively, so that the transition connecting piece is fixedly connected to the far end of the outer pipe.

According to the invention, the pair of cut holes are arranged on the outer tube, the transition connecting piece detachably connected with the near end of the valve accommodating tube is arranged at the same time, the corresponding through holes are arranged on the transition connecting piece, and then the fixing rod is arranged in the through holes of the transition connecting piece and the cut holes of the outer tube in a penetrating manner, so that the outer tube and the valve accommodating tube are firmly connected together through the firm connection of the transition connecting piece and the outer tube, and the valve accommodating tube can be conveniently detached during detachment.

Preferably, the first and second air flow paths are arranged in parallel,

the inner wall of the flange pipe and the outer wall of the circular pipe are bonded by adhesive to further stably and fixedly connect the transition connecting piece at the far end of the outer pipe and seal the interior of the transition connecting piece.

Preferably, the first and second air flow paths are arranged in parallel,

the outer surface of the distal end of the transition piece is provided with an axial lug;

the inner surface of the proximal end of the valve accommodating tube is provided with an axial groove, the proximal end of the valve accommodating tube is sleeved outside the distal end of the transition connecting piece, and the axial convex block of the transition connecting piece is embedded in the axial groove of the valve accommodating tube to form clamping connection so as to prevent relative rotation.

Preferably, the first and second air flow paths are arranged in parallel,

the outer surface of the distal end of the transition piece is provided with an axial groove;

the inner surface of the near end of the valve accommodating tube is provided with an axial convex block, the near end of the valve accommodating tube is sleeved outside the far end of the transition connecting piece, and the axial convex block of the valve accommodating tube is embedded in the axial groove of the transition connecting piece to form clamping connection so as to prevent relative rotation.

Preferably, the first and second liquid crystal display panels are,

the outer surface of the distal end of the valve accommodating tube is provided with an axial bump;

the inner surface of the near end of the sheath pipe sleeve is provided with an axial groove, the near end of the sheath pipe sleeve is sleeved outside the far end of the valve accommodating pipe, and the axial convex block of the valve accommodating pipe is embedded in the axial groove of the sheath pipe sleeve to form clamping connection so as to prevent relative rotation.

Preferably, the first and second liquid crystal display panels are,

the distal outer surface of the valve accommodating tube is provided with an axial groove;

the inner surface of the proximal end of the sheath pipe sleeve is provided with an axial convex block, the proximal end of the sheath pipe sleeve is sleeved outside the distal end of the valve accommodating tube, and the axial convex block of the sheath pipe sleeve is embedded in the axial groove of the valve accommodating tube to form clamping connection so as to prevent relative rotation.

and the two ends of the proximal connecting piece are respectively detachably connected with the transition connecting piece and the valve accommodating tube, and the transition connecting piece and the valve accommodating tube are connected together through the proximal connecting piece.

Preferably, the first and second liquid crystal display panels are,

the outer surface of the middle section of the transition connecting piece is provided with a transition external thread;

the inner surface of the near end connecting piece is provided with a near end piece internal thread, and the near end piece internal thread is matched and connected with the transition external thread of the transition connecting piece, so that the near end connecting piece is sleeved outside the transition connecting piece;

the outer surface of the proximal end of the valve accommodating tube is provided with a ring of tube bulges;

the inner surface of the far end of the near end connecting piece is provided with a circle of hooking protrusion, and the tube protrusion of the valve accommodating tube is hooked on the hooking protrusion of the near end connecting piece, so that the near end connecting piece is sleeved outside the near end of the valve accommodating tube.

Preferably, the first and second liquid crystal display panels are,

the outer surface of the middle section of the transition connecting piece is provided with a circle of pipe bulges;

the inner surface of the near end connector is provided with a circle of hooking protrusions, and the hooking protrusions at the near end of the near end connector are hooked through the pipe protrusions of the transition connector, so that the near end connector is sleeved outside the transition connector;

the proximal outer surface of the valve containment tube has external tube threads;

the inner surface of the far end of the near end connector is provided with a near end part inner thread, the outer thread of the valve accommodating tube is matched and connected with the inner thread of the near end part of the near end connector, and therefore the near end connector is sleeved outside the near end of the valve accommodating tube.

Preferably, the first and second liquid crystal display panels are,

the outer surface of the middle section of the valve accommodating tube is provided with outer threads;

the inner surface of the proximal end of the distal connecting piece is provided with a distal piece inner thread, and the outer thread of the valve accommodating tube is matched and connected with the distal piece inner thread of the distal connecting piece, so that the distal connecting piece is sleeved outside the valve accommodating tube;

the inner surface of the far end connecting piece is provided with a circle of hooking protrusions;

the outer surface of the near end of the sheath pipe sleeve is provided with a circle of pipe protrusions, and the pipe protrusions of the sheath pipe sleeve are hooked on the hooking protrusions of the far-end connecting piece, so that the far-end connecting piece is sleeved outside the near end of the sheath pipe sleeve.

Preferably, the first and second air flow paths are arranged in parallel,

the outer surface of the middle section of the valve accommodating tube is provided with a ring of tube bulges;

the inner surface of the near end of the far-end connector is provided with a circle of hooking protrusions, and the hooking protrusions at the near end of the far-end connector are hooked by the tube protrusions of the valve accommodating tube, so that the far-end connector is sleeved outside the valve accommodating tube;

the outer surface of the near end of the sheath sleeve is provided with outer threads;

the inner surface of the far end connector is provided with a far end part inner thread, and the outer thread of the sheath pipe sleeve is matched and connected with the inner thread of the far end part of the far end connector, so that the far end connector is sleeved outside the near end of the sheath pipe sleeve.

Preferably, the sheath sleeve has:

Preferably, the handle case has a distal-section inner wall having:

the plurality of far-section axial reinforcing ribs are axially and fixedly arranged on the far-section inner wall of the handle shell;

the plurality of far-section radial reinforcing ribs are fixedly arranged on the inner wall of the far section of the handle shell in the radial direction;

the distal axial stiffener and the distal radial stiffener can be attached to the outer walls of the transition piece and the proximal connector so that the transition piece and the proximal connector are horizontally retracted without rotation.

the proximal section of the inner tube penetrates through the inner part of the middle tube, the distal section of the inner tube penetrates through the transition connecting piece in a non-rotatable manner and penetrates through the proximal end of the valve accommodating tube, a cavity sealing washer is arranged at the joint of the distal end of the transition connecting piece and the proximal end of the valve accommodating tube, the cavity sealing washer is sleeved on the periphery of the distal section of the inner tube, the distal end of the inner tube is connected with the valve restraining tube, the outer surface of the proximal end of the inner tube is provided with an outer thread of the inner tube, the outer thread of the inner tube is connected to the inner thread of the middle tube in a matched manner, and the middle tube can be driven to convey the artificial valve towards the distal end by the rotation of the middle tube;

the front pushing knob is arranged at the near end of the handle shell, niu Bika of the front pushing knob is connected to the pipe wall of the near end of the middle pipe in a buckled mode, and the front pushing knob is rotated in the circumferential direction to drive the middle pipe to rotate.

the utility model discloses a heart valve prosthesis, including well core pipe, the outer wall cover of well core pipe is equipped with the solid fixed ring of distal end, the outer wall circumference of the solid fixed ring of distal end is equipped with a rubber circle, the inner wall of inner tube compresses tightly the rubber circle of well core pipe distal end, with incite somebody to action prosthetic valve seals with the external world and keeps apart.

Preferably, the outer wall of the outer sheath tube is provided with scales, a retraction end point can be determined according to the scales, the distal end of the outer sheath tube is provided with a developing ring, and a retraction position is determined according to the developing ring and the scales; the inner wall smoothness and hardness of the inner sheath tube are greater than those of the outer sheath tube.

Preferably, the first and second air flow paths are arranged in parallel,

the sheath tube base of the sheath tube sleeve is internally provided with a sheath sealing gasket, and the distal end of the valve accommodating tube is hermetically connected with the proximal end of the sheath tube sleeve through the sheath sealing gasket.

Compared with the prior art, the invention has the beneficial effects that:

1) According to the invention, the forward push knob is connected with the middle pipe in a buckling manner, so that the forward push knob can stably rotate the middle pipe, and the middle pipe can stably move the inner pipe to push the valve bundling pipe to be conveyed towards the far end.

2) According to the invention, through the design that the shapes of the middle section and the far section of the inner tube are non-circular and are matched with the shapes of the inner surface of the transition connecting piece, the transition connecting piece prevents the inner tube from rotating and can linearly convey the artificial valve towards the far end in the conveying process.

3) The handle shell is provided with a groove for clamping in a square frame, the two end faces of the retraction knob are provided with corresponding bulges, and the bulges of the retraction knob are embedded in the groove of the handle shell to limit the retraction knob, so that the stability of the retraction knob in the retraction process and the stability of a valve accommodating pipe and a sheath pipe sleeve which are connected together by an outer pipe and the outer pipe which are arranged in the retraction knob in a penetrating way are improved.

4) According to the valve accommodating pipe, the pair of cutting holes are formed in the outer pipe, the corresponding through holes are formed in the transition connecting piece, and then the fixing rod is arranged in the through holes of the transition connecting piece and the through holes of the outer pipe in a penetrating mode, so that the outer pipe and the valve accommodating pipe are firmly connected together through the firm connection of the transition connecting piece and the outer pipe, and the valve accommodating pipe can be conveniently detached during detachment. And further bonding the inner wall of the flange pipe and the outer wall of the circular pipe by using an adhesive to stably and fixedly connect the transition connecting piece to the far end of the outer pipe and seal the interior of the transition connecting piece.

5) According to the invention, the cavity sealing washer is arranged at the joint of the far end of the transition connecting piece and the near end of the valve accommodating tube, the sheath sealing washer is arranged between the valve accommodating tube and the sheath tube base of the sheath tube sleeve, the rubber ring is arranged on the far end fixing ring, and the locking knob with the sealing washer is arranged on the locking head, so that all possible potential channels are sealed and isolated from the outside, and the sealing performance of the conveyor system is further improved.

Drawings

FIG. 1A is a side view of the trans-apical mitral valve replacement transporter of the present invention;

FIG. 1B is a schematic perspective exploded view of the transapical mitral valve replacement transporter of the present invention;

FIG. 1C is a schematic cross-sectional view of the transapical mitral valve replacement transporter of the present invention;

FIG. 1D is a side elevation schematic view of the transapical mitral valve replacement conveyor of the present invention with the handle housing 10 removed;

FIG. 1E is a perspective view of the inner assembly of the distal section of the trans-apical mitral valve replacement delivery apparatus of the present invention;

FIG. 2A is a schematic view of the internal structure of one half of the handle case 10 of the present invention;

FIG. 2B is a schematic view showing the disassembled inner structure of the handle case 10 provided with the inner tube 30 according to the present invention;

fig. 3 is a schematic structural view of the middle tube 20 of the present invention;

FIGS. 4A-4B are schematic views illustrating the connection relationship between the inner tube 30 and the transition piece 75 according to the present invention;

FIGS. 4C-4D are schematic views showing the connection relationship between the inner tube 30 and the valve constricting tube 35 according to the present invention;

FIGS. 5A-5B are schematic structural views of the push knob 40 of the present invention;

FIG. 6 is a schematic view showing the structure of the core tube 51 and the locking head 53 according to the present invention;

FIG. 7 is a schematic view of the outer tube 70 and retraction knob 60 of the present invention;

FIG. 8 is a schematic view of the retraction knob 60 of the present invention;

FIGS. 9A-9D are views of the connection of the transition piece 70, the valve receiving tube 85 and the valve cinching tube 35 of the present invention;

FIG. 10A is a side view of the sheath sleeve 90;

FIG. 10B is a schematic cross-sectional view of the sheath 90;

FIG. 11A is a perspective view of proximal connector 82;

fig. 11B is a perspective view of the distal connector 88.

Detailed Description

The following embodiments of the present invention are provided by way of specific examples, and other advantages and effects of the present invention will be readily apparent to those skilled in the art from the disclosure herein. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope of the present invention. It should be noted that the features in the following embodiments and examples may be combined with each other without conflict.

In the field of interventional medical devices, a "distal end" and a "distal segment" are defined as an end or a segment away from an operator during a surgical procedure, and a "proximal end" and a "proximal segment" are defined as an end or a segment close to the operator during the surgical procedure.

In the present invention, unless otherwise specifically stated or limited, the terms "mounted," "connected," "fixed," and the like are to be construed broadly and may, for example, be fixedly connected, detachably connected, or integrally formed; the connection can be mechanical connection, electrical connection or communication connection; either directly or indirectly through intervening media, either internally or in any other suitable relationship, unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In the present invention, "axial" generally refers to the axial direction of the distal end and the proximal end, and may be understood as the direction of the central axis or the direction parallel to the central axis, although sometimes "axial" may also refer to the axial direction of the axially symmetric element itself. "radial" refers to a direction perpendicular to the "axial" direction.

As shown in fig. 1A-1E, a transapical mitral valve replacement transporter of the present invention is shown. The proximal section of the trans-apical mitral valve replacement conveyor of the present invention comprises, in order from outside to inside, a handle housing 10, a middle tube 20, an inner tube 30, a middle tube 51 and a tether 52, the proximal end further comprises a push knob 40 and a locking head 53, the distal sections are, in order from outside to inside, the handle housing 10, a retraction knob 60, an outer tube 70, the distal end of the middle tube 20, the distal section of the inner tube 30, the distal section of the middle tube 51 and the distal section of the tether 52, the distal sections are, in order from the proximal end to the distal end, an outer tube 70, a transition connector 75, a valve accommodating tube 85 and a sheath tube sleeve 90, a proximal connector 82 detachably connecting the transition connector 75 and the valve accommodating tube 85, a distal connector 88 detachably connecting the valve accommodating tube 85 and the sheath tube sleeve 90, and a valve constricting tube 35 connected to the distal end of the inner tube 30 and disposed in the valve accommodating tube 85.

As shown in fig. 2A and 2B, the handle case 10 of the present example may be a whole body formed by two symmetrical half cases that are covered and closed in an axisymmetric manner, and the edge of the case may have a plurality of screw holes that are respectively screwed into the screw holes at symmetrical positions of the two half cases to be covered and connected. The inner wall of the handle shell 10 at the near section is provided with a plurality of axial reinforcing ribs 11 at the near section, and the axial reinforcing ribs are axially and fixedly arranged on the inner wall of the near section of the handle shell; a plurality of proximal radial reinforcing ribs 12 are radially and fixedly arranged on the proximal inner wall of the handle shell; the proximal axial ribs 11 and the proximal radial ribs 12 can be attached to the outer wall of the middle tube 20 to increase the stability of the middle tube 20 when it is rotated (see the examples described later). The inner wall of the far section of the handle shell 10 is provided with a plurality of far section axial reinforcing ribs 13 which are axially and fixedly arranged on the inner wall of the far section of the handle shell 10; a plurality of far-section radial reinforcing ribs 14 are radially and fixedly arranged on the far-section inner wall of the handle shell 10; the distal axial ribs 13 and the distal radial ribs 14 may fit over the outer walls of the transition piece 75 and the proximal connector 82 to allow the transition piece 75 and the proximal connector 82 to be retracted horizontally and linearly without rotation (see the examples described below). The proximal outer wall of the handle shell 10 has a number of corresponding circumferential female rings 15 or circumferential male rings (see in particular the examples described later). The handle housing 10 has an open cavity at the distal section, a frame 16 is arranged around the open cavity, the frame 16 defines the open cavity, and a ring of grooves 161 for locking are arranged on the frame wall at the distal end and/or the frame wall at the proximal end of the frame 16 (see the example of the retraction knob 60 described later for the functions of the frame 16 and the grooves 161). The distal section of the handle shell has a shell aperture 17 therethrough which can be used to view the scale on the inner tube 30 to determine the delivery location. The inner wall of the distal section of the handle housing 10 has a plurality of axially disposed positioning plates 18, and the positioning plates 18 are engageable with guide plates 72 at the proximal end of the outer tube 70 to prevent rotation of the outer tube 70 such that the outer tube 70 can only be moved proximally by the retraction knob.

As shown in fig. 3, in this example, the middle tube 20 is inserted into the handle housing 10 and can rotate in the handle housing 10, the proximal end of the middle tube 20 is connected with the proximal forward push knob 40 in a snap-fit manner, and the distal end may extend into the proximal end of the outer tube 70, or may not extend into the proximal end of the outer tube 70. The inner surface of the middle pipe 20 is provided with middle pipe internal threads 21 which can be matched and connected with the internal pipe external threads on the outer surface of the internal pipe 30. The outer wall of the proximal end of the middle tube 20 is provided with at least one axial clamping plate 22; the axial clamping plate 22 of the middle pipe 20 is embedded in the axial groove of the forward push knob 40, so that the middle pipe 20 is driven to rotate by the circumferential rotation of the forward push knob 40. Another example is that the proximal outer wall of the middle tube 20 has at least one axial groove; the axial clamping plate of the forward-push knob 40 is embedded in the axial groove of the middle pipe 20, so that the circumferential rotation of the forward-push knob 40 drives the middle pipe 20 to rotate, which is not shown in the figure. When the middle tube 20 rotates, the outer wall can be attached to the proximal axial reinforcing rib 11 and the proximal radial reinforcing rib 12 of the handle shell 10 and supported by the proximal axial reinforcing rib 12, so that the middle tube 20 does not shake due to the fact that the middle section supporting force is not enough due to too long length during rotation.

As shown in fig. 1C, 2B and 4A-4B, in this example, the proximal section of the inner tube 30 is inserted inside the middle tube 20, the middle section of the inner tube 30 is inserted through the outer tube 70 and the transition piece 75 in sequence until its distal end is inserted into the proximal end of the valve accommodating tube 85, and the distal end of the inner tube 30 abuts against the proximal end of the valve restraining tube 35 pre-positioned in the valve accommodating tube 85. The outer surface of the proximal end of the inner tube 30 has outer threads 31 of the inner tube, the outer threads 31 of the inner tube are connected to the inner threads 21 of the middle tube 20 in a matching manner, and the rotation of the middle tube 20 can drive the inner tube 30 to push the valve restraining tube 85 towards the distal end. The outer wall of the inner tube 30 is provided with scales, so that the conveying progress can be observed through the shell hole 17 at the far section of the handle shell 10. In order to prevent the inner tube 30 from rotating, and to be moved linearly toward the distal end by the rotating middle tube 20, the outer circumferences of the radial cross sections of the middle section and the distal section (the middle section and the distal section except for the proximal external thread) of the inner tube 30 are set to be non-circular. While the inner ring of the radial cross-section of the transition piece 75 is arranged to be in radial cross-section with the middle and distal sections of the inner tube 30The outer ring of (a) is non-circular and has a size matched with the outer ring of (b), so that the middle section and the distal section of the inner tube 30 are inserted into the transition piece 75 and cannot rotate, and the transition piece 75 limits the rotation of the inner tube 30 and only can move linearly towards the distal end (see the following example). The outer ring of the radial section of the middle section and the far section of the inner tube 30 can be designed into a D shape, a square shape,

The shape is square or polygonal, even the shape can be star-shaped, or the outer surface has a plurality of bulges, etc., and the shapes can be various non-circular shapes. The inner tube 30 has a proximal end fixing ring 32 on its inner surface, which can be attached to the outer surface of the proximal section of the core tube 51 to provide support for the core tube 51 and maintain the concentricity of the core tube 51 and the stability of the system (see the following example). As shown in fig. 4C-4D, the inner tube 30 is configured to have an inner step 33 at the distal end, and the inner step 33 can be in good mating abutment with the valve constriction tube 35 (see the examples below).

As shown in fig. 5A to 5B, in the present example, the push-forward knob 40 is movably provided at the proximal end of the handle case 10, and the movable arrangement is intended to allow the push-forward knob 40 to freely rotate at the proximal end of the handle case 10 without falling off the proximal end of the handle case 10. Specifically, the distal inner wall of the push knob 40 has a plurality of circumferential protrusions 42, and the push knob 40 is disposed at the proximal end of the handle housing 10 by fitting the circumferential protrusions 42 of the push knob 40 into the circumferential recesses 15 of the handle housing 10, and the circumferential protrusions 42 of the push knob 40 are freely rotatable within the circumferential recesses 15 of the proximal end of the handle housing 10. As another example, the distal end inner wall of the push-forward knob 40 has a plurality of circumferential concave rings, and the push-forward knob 40 is rotatably provided at the proximal end of the handle housing 10 by the circumferential convex rings of the handle housing 10 being fitted into the circumferential concave rings of the push-forward knob 40. Both of these examples pertain to an example in which the distal end of the push knob 40 is fitted over the proximal end of the handle housing 10. Another example, not shown, is an example in which the distal end of the push knob 40 is inserted inside the proximal end of the handle case 10, a plurality of circumferential convex rings are provided on the outer wall of the distal end of the push knob 40, and a circumferential concave ring is provided on the inner wall of the proximal end of the handle case 10; as yet another example, a circumferential concave ring is provided on the outer wall of the distal end of the push knob 40 and a circumferential convex ring is provided on the inner wall of the proximal end of the handle case 10. In either way, the free rotational connection of the distal end of the push knob 40 to the proximal end of the handle housing 10 is achieved, and the objectives of the present invention are achieved.

In this example, the button wall of the forward knob 40 is snap-connected to the proximal wall of the middle tube 20, and circumferential rotation of the forward knob 40 rotates the middle tube 20. The proximal inner wall of the push knob 40 has at least one axial groove 41; the axial clamping plate 22 of the outer wall of the proximal end of the middle tube 20 is embedded in the axial groove 41 of the forward push knob 40, so that the circumferential rotation of the forward push knob 40 drives the middle tube 20 to rotate. In another example not shown in the drawings, the inner wall of the proximal end of the push knob 40 has at least one axial catch plate, and the axial catch plate of the push knob 40 is inserted into the axial groove of the middle tube 20, so that the middle tube 20 is rotated by the circumferential rotation of the push knob 40. With either of the two exemplary snap-fit connections described above, the push knob 40 can be configured to stably rotate the middle tube 20 such that the middle tube 20 can stably push the inner tube 30 forward and thereby push the valve pinching tube 35 connected to the distal end of the inner tube 30 to distally deliver the prosthetic valve. Of course, it is also an example that the axial catch plate may be disposed on the inner wall of the proximal end of the middle tube 20, and the axial groove is disposed on the outer wall of the proximal end of the forward push knob 40, so that the axial catch plate on the inner wall of the proximal end of the middle tube 20 is snap-connected into the axial groove on the outer wall of the proximal end of the forward push knob 40 to achieve the snap-connection. As yet another example, the axial groove is formed on the proximal inner wall of the middle tube 20, and the axial catch is formed on the proximal outer wall of the forward knob 40, so that the axial catch on the proximal outer wall of the forward knob 40 is snap-fitted into the axial groove on the proximal inner wall of the middle tube 20 to achieve the snap-fit connection. Any clamping method can be used as long as the forward push knob 40 and the middle tube 20 can be clamped in the circumferential direction. The push knob 40 has a push washer 43 interposed between the inner proximal wall of the handle housing 10 and the outer proximal wall of the middle tube 30 to reduce friction between the handle housing 10 and the middle tube 20 when rotated.

As shown in FIG. 6, in the present example, the central core tube 51 is inserted through the inner tube 30 at the middle section, and the proximal end thereof passes through the proximal end of the forward push knob 40; the proximal section of the core tube 51 fits through the proximal end fixing ring 32 of the inner tube 30, and the proximal end fixing ring 32 provides a supporting force to the core tube 51, so as to maintain the coaxiality of the core tube 51 and the stability of the system. The far end of the central core tube 51 is located in the middle section or the far section of the inner tube 30, the far end outer wall of the central core tube 51 is sleeved with a far end fixing ring 511, the peripheral wall of the outer wall of the far end fixing ring 511 is provided with a circle of rubber ring 512, and the inner wall of the inner tube 30 is pressed on the rubber ring 512 at the far end of the central core tube 51 so as to seal and isolate the artificial valve in the valve accommodating tube 85 from the outside.

Continuing with FIG. 6, in this example, the distal end of the locking head 53 is movably and rotatably coupled to the proximal end of the push knob 40. The movable and rotatable connection between the distal end of the locking head 53 and the proximal end of the forward knob 40 may be the same as the rotatable connection between the forward knob 40 and the handle housing 10, which is not described herein, so that the forward knob 40 may be rotated without the locking head 53 rotating. A locking knob 531 with a sealing ring is provided on the middle section of the locking head 53, a nut (not shown) is provided on the proximal end of the locking head 53, and the proximal end of the core tube 51 is fixed in the distal end of the locking head 53.

As shown in FIG. 1C, in this example, the tether 52 is passed through the core tube 51 at a middle portion thereof, the distal end of the tether 52 is passed through the core tube 51 to be connected to the prosthetic valve, and the proximal end of the tether 52 is passed through the proximal end of the locking head 53 and can be doubly locked by the locking knob 531 and/or the nut.

As shown in fig. 7, the outer tube 70 of the present example is inserted into the distal section of the handle case 10, and the distal section of the handle case 10 is fitted over the outer tube 70. The distal end of the middle tube 20 may extend all the way into the proximal end of the outer tube 70, i.e. the outer tube 70 is located between the distal section of the handle housing 10 and the distal end of the middle tube 20, although it is also possible that the middle tube 20 does not extend into the proximal end of the outer tube 70. The outer tube 70 has an inner tube 30 extending from the distal end of the middle tube 20. A tube hole 711 is further formed through the wall of the outer tube 70, the tube hole 711 corresponds to the position of the shell hole 17 of the handle shell 10, and the scale on the wall of the inner tube 30 can be observed through the shell hole 17 and the tube hole. The outer surface of the middle section of the outer tube 70 has an outer tube external thread 71, and the outer tube external thread 71 is connected with the knob internal thread 61 of the retraction knob 60 disposed in the cavity of the distal section of the handle case 10 in a matching manner, so that the outer tube 70 can be driven to be linearly retracted toward the proximal end when the retraction knob 60 is rotated. The proximal end of the outer tube 70 is a cylindrical tube, and the outer wall of the cylindrical tube is provided with a plurality of guide plates 72 arranged axially; the guide plate 72 can be engaged with the positioning plate 18 on the inner wall of the distal section of the handle housing 10, so that the outer tube 70 can be non-rotatably withdrawn and can only be moved in a linear manner proximally by the withdrawal knob 60. The far end of the outer tube 70 is a round tube 73, and the outer wall of the round tube 73 is provided with a cut hole 74 with a pair of walls; the distal tube 73 of the outer tube 70 is insertable into the proximal end of the transition piece 75 with a cut-out 74 for secure attachment to the transition piece 75.

As shown in fig. 8, the retraction knob 60 of the present example is provided in an open cavity of the distal section of the handle case 10, and the retraction knob 60 is fitted over the outer tube 70. The inner surface of the retraction knob 60 has a knob inner thread 61, the knob inner thread 61 is in fit connection with the outer tube outer thread 71, and the outer tube 70, the valve accommodating tube 85 and the sheath sleeve 90 connected with the outer tube 70 are retracted proximally by rotating the retraction knob 60 to release the prosthetic valve. The retraction knob 60 has an inner knob ring 63 with knob internal threads 61 disposed on an inner surface of the inner knob ring 63; the outer button ring 64 is sleeved outside the inner button ring 63; the support ring 65 is located between the inner and outer button rings 63 and 64 for fixedly connecting the inner and outer button rings 63 and 64, so that the outer diameter of the outer button ring 64 can be enlarged for convenient rotation without increasing material and weight. The withdrawing knob 60 is provided with a circle of protrusions 62 for clamping on the far-end side and the near-end side respectively, the protrusions 62 of the withdrawing knob 60 are embedded in the grooves 161 of the square frame 16 of the handle shell 10, so that the withdrawing knob 60 cannot sway left and right and is more tightly attached to the handle shell 10, thereby well limiting the withdrawing knob 60, and improving the stability of the withdrawing knob 60 in the withdrawing process and the stability of the withdrawing process of the valve accommodating tube 85 and the sheath tube sleeve 90 which are connected together by the outer tube 70 and the outer tube 70 which are arranged in the withdrawing knob 60 in a penetrating way. In a further example, the protrusions 62 for locking are a plurality of protrusions (as shown in the figure) uniformly arranged in a circle, and the protrusions are uniformly embedded in the grooves 161 of the handle case 10; in another further example, the locking protrusion 62 is a ring-shaped protrusion that is engaged with the groove 161 of the handle case 10. The retraction knob 60 may also have two retraction washers 66 disposed on the proximal and distal faces of the retraction knob 60 that fit over the outer tube 70 and snap into the protrusions 62 to reduce friction and improve stability during rotation. The protrusion 62 has a width smaller than that of the retraction washer 66, and the retraction knob 60 is rotatably coupled to the handle case 10 by the retraction washer 66.

As shown in fig. 9A to 9D, in this example, the transition piece 75 is a pipe with an external thread, and the middle section and the distal section of the inner pipe 30 can pass through the transition piece 75, so that the transition piece 75 can prevent the inner pipe 30 from being rotated and can only be driven by the middle pipe 20 to advance straight to the distal end, the inner ring of the radial section of the transition piece 75 is designed to have a non-circular shape and a size that are the same as the outer ring of the inner pipe 30, for example, the outer ring of the radial section of the middle section and the distal section of the inner pipe 30 is designed to have a D shape, and the inner ring of the radial section of the transition piece 75 is also designed to have a D shape, so that the inner pipe 30 can be prevented from being rotated by the middle pipe 20 under the limitation of the transition piece 75. Similarly, if the outer ring of the radial cross section of the middle section and the distal section of the inner tube 30 is designed to be square-shaped,

Shaped, square or polygonal, with a plurality of protrusions, star-shaped, etc., the inner circumference of the radial cross-section of the transition piece 75 is correspondingly designed as square,

A shape, square or polygon, a number of indentations, a star shape, etc., as long as the cross-sectional shape is a non-circular shape, the purpose of the present invention of non-rotation of the inner tube 30 is achieved. The proximal end of the transition piece 75 is a flange tube 76, the flange tube 76 is disposed through the outer tube 73 at the distal end of the outer tube 70, a pair of through-wall holes 77 are formed at corresponding positions on the flange tube 76, and a pair of fixing rods 78 are disposed through the through-wall holes 77 of the transition piece 75 and the cut-out holes 74 of the outer tube 70, respectively, so as to fixedly connect the transition piece 75 to the distal end of the outer tube 70. So that the outer tube 70 can be stably retracted during the retraction process without the valve accommodating tube 85 falling off. The inner wall of the flange pipe 76 and the outer wall of the circular pipe 73The transition piece 75 may be further adhesively bonded to securely attach the transition piece 75 to the distal end of the outer tube 70 and to seal the interior of the transition piece 75. The outer tube 70 and the valve accommodating tube 85 are firmly connected together by the firm connection of the transition piece 75 and the outer tube 70, and can be conveniently detached when detached, in this example, by providing a pair of cut holes 74 on the outer tube 70, providing the transition piece 75 detachably connected to the proximal end of the valve accommodating tube 85, providing the corresponding through holes 77 on the transition piece 75, and then inserting the fixing rods 78 into the through holes 77 of the transition piece 75 and the cut holes 74 of the outer tube 70. The distal end of the transition piece 75 is a transition piece cylindrical tube that can be inserted into and attached to the proximal end of the valve receiving tube 85. The transition piece barrel outer surface at the distal end of the transition piece 75 has an axial protrusion 791 or axial recess, which allows it to be connected to the valve receiving tube 85 to prevent relative rotation. In the process that the transition piece 75 is driven by the outer tube 70 to retract towards the proximal end, the distal axial stiffener 13 and the distal radial stiffener 14 are arranged on the inner wall of the distal section of the handle shell 10, and the outer wall of the transition piece 75 can only be attached to the axial stiffener 13 and the distal radial stiffener 14, so that the rotation of the transition piece 75 is limited and can only be retracted towards the proximal end horizontally.

In this example, the valve receiving tube 85 is a circular tube with the valve constricting tube 35 pre-positioned inside. The distal end of the inner tube 30 extends into the proximal end of the valve receiving tube 85 and connects to the proximal end of the valve constricting tube 35 pre-positioned therein. The transition piece circular tube distal to the transition piece 75 is inserted into the flare proximal to the valve receiving tube 85. The junction of the distal end of the transition piece 75 and the proximal end of the valve containment tube 85 has a lumen sealing gasket 851, with the lumen sealing gasket 851 fitting over the outer periphery of the distal section of the inner tube 30, and with the lumen sealing gasket 851 being held against a flared step at the proximal end of the valve containment tube 85 by a transition piece cylindrical tube at the distal end of the transition piece 75. Further, the inner surface of the proximal end of the valve accommodating tube 85 is provided with an axial groove 852, the proximal end flaring of the valve accommodating tube 85 is sleeved outside the transition piece circular tube at the distal end of the transition piece 75, and the axial protrusion 791 outside the transition piece circular tube of the transition piece 75 is embedded in the axial groove 852 of the valve accommodating tube 85 to form a clamping connection so as to prevent the relative rotation of the two. In another example, not shown, the transition piece barrel outer surface at the distal end of the transition piece 75 is provided with an axial groove; the inner surface of the proximal end of the valve accommodating tube 85 is provided with an axial convex block, the flared proximal end of the valve accommodating tube 85 is sleeved outside the circular tube of the transition piece at the distal end of the transition piece 75, and the axial convex block of the valve accommodating tube 85 is embedded in the axial groove of the transition piece 75 to form clamping connection so as to prevent relative rotation of the two. In a preferred example, the outer surface of the valve accommodating tube 85 has an outer reinforcing rib having an indicator, such as a "K" indicator, since the mitral annulus is not circular but has a D-like structure, so that the outer stent of the artificial mitral valve is also D-shaped to match the anatomy, and the "K" structure is provided on the outer surface of the valve accommodating tube as an indicator of the valve direction for better mounting the artificial mitral valve on the mitral valve. In this example, the distal outer surface of the valve accommodating tube 85 is provided with axial protrusions 853, whereby the valve accommodating tube 85 and the sheath 90 can be prevented from relative rotation, see in particular the example described later.

In this example, the valve constricting tube 35 is a hollow tube that is pre-positioned within the valve receiving tube 85. The valve converging tube 35 has a flared structure with an opening facing the distal end and is compressible for placing a prosthetic valve therein. When the valve prosthesis is pre-folded, the proximal end of the valve prosthesis is folded at the trumpet-shaped structure, and the other part is positioned in a larger space in the valve accommodating tube 85. The outer wall of the proximal end of the valve constricting tube 35 is configured with an outer step 351, and the inner step 33 of the inner tube 30 fits over and abuts the outer step 351 of the valve constricting tube 35. In another example, the proximal inner wall of the valve cinching tube 35 is configured as an inner step, the distal outer wall of the inner tube 30 is configured with an outer step, and the inner step of the valve cinching tube 35 is mated over and abuts the outer step of the inner tube 30. This way the object of the invention can be achieved.

In this example, a sheath 90, shown in figures 10A-10B, serves as a delivery channel for the prosthetic valve and is attached to the distal end of the valve-containing tube 85. Rotation of the middle tube 20 causes the inner tube 30 to push against the valve pinching tube 35 to deliver the prosthetic valve distally along the central axis of the sheath 90. The sheath tube 90 has a sheath tube base 91, an inner sheath tube 92, and an outer sheath tube 93. The sheath base 91 is located at the proximal end of the sheath tube and has a cavity therein, and the distal end of the valve accommodating tube 85 is inserted into the cavity of the sheath base 91. The distal end of the cavity has a stepped opening, a sheath sealing gasket 94 (not shown in fig. 10B, see fig. 1C) is disposed at the stepped opening of the sheath tube base 91 of the sheath tube housing 90, the distal end of the valve accommodating tube 85 is pressed against the sheath sealing gasket 94, and the distal end of the valve accommodating tube 85 is sealingly connected in the sheath tube base 91 of the sheath tube housing 90 by the sheath sealing gasket 94. To prevent relative rotation between the valve receiving tube 85 and the sheath 90 during delivery and retraction. In the present example, an axial groove 911 is formed in the inner surface of the sheath base 91 at the proximal end of the sheath tube 90, the proximal end of the sheath tube 90 is sleeved outside the distal end of the valve accommodating tube 85, and the axial protrusion 853 of the valve accommodating tube 85 is embedded in the axial groove 911 of the sheath tube 90 to form a snap joint so as to prevent relative rotation. In another example not shown in the drawings, an axial protrusion may be further disposed on the inner surface of the sheath base 91 at the proximal end of the sheath sleeve 90, an axial groove is disposed on the outer surface of the distal end of the valve accommodating tube 85, the proximal end of the sheath sleeve 90 is sleeved outside the distal end of the valve accommodating tube 85, and the axial protrusion of the sheath sleeve 90 is embedded in the axial groove of the valve accommodating tube 85 to form a snap joint so as to prevent relative rotation. This example, although not shown in the drawings, can also achieve the object of the present invention. The proximal end of the inner sheath 92 is attached to the distal end of the sheath mount 91. The outer sheath 93 is sleeved outside the inner sheath 92, and the inner wall of the inner sheath 92 has smoothness and hardness greater than those of the outer sheath 93. The proximal end of the outer sheath 93 is attached to the distal end of the sheath mount 91. In a preferred example, the outer wall of the outer sheath 93 has a scale, and the retraction end point can be determined according to the scale, and the distal end of the outer sheath 93 has a developing ring 95, and the retraction position is determined according to the developing ring 95 and the scale.

As shown in FIG. 11A, in this example, the proximal connector 82 is provided so that the distal end of the transition piece 75 is more securely inserted within the proximal end of the valve receiving chamber 85. A proximal connector 82 is sleeved over the periphery of transition piece 75 at its distal end to the proximal end of valve receiving lumen 85. The proximal connector 82 is a cylinder, and may be formed by two half-cylinder shells symmetrically covered and assembled, and the two side walls are fixedly connected by bolts. The proximal connector 82 is detachably connected at both ends to the transition piece 75 and the valve accommodating tube 85, respectively, and the transition piece 72 and the valve accommodating tube 85 are firmly connected together by the proximal connector 82.

The present example provides the solution that both ends of the proximal connector 82 are detachably connected to the transition piece 75 and the valve accommodating tube 85, respectively, and specifically, the outer surface of the middle section of the transition piece 75 is provided with external transition threads 751; the proximal inner surface of proximal connector 82 has proximal member internal threads 821 that matingly engage proximal member internal threads 821 of proximal connector 82 via external transition threads 751 of transition piece 75 to thereby sleeve proximal connector 82 over the exterior of transition piece 75. The proximal outer surface of the valve containment tube 85 has a ring of tube protrusions 854; the distal inner surface of the proximal connector 82 has a ring of barbs 822, and the tube protrusions 854 of the valve accommodating tube 85 are hooked on the barbs 822 of the proximal connector 82, so that the proximal connector 82 is sleeved outside the proximal end of the valve accommodating tube 85. In this manner, the transition piece 75 can be detached from the valve receiving tube 85 by simply rotating the proximal connector 82 such that the proximal piece internal threads 821 of the proximal connector 82 disengage from the transition external threads 751 of the transition piece 75.

As another example (not shown), the intermediate section of transition piece 75 may have a ring of tube protrusions on its outer surface; the inner surface of the proximal end of the proximal connector 82 is provided with a circle of hooking protrusions, and the hooking protrusions at the proximal end of the proximal connector 82 are hooked by the tube protrusions of the transition connector 75, so that the proximal connector 82 is sleeved outside the transition connector 75. The proximal outer surface of the valve receiving tube 85 has external tube threads. The distal inner surface of the proximal connector 82 has proximal piece internal threads that mate the outer threads of the valve containment tube 85 to the proximal piece internal threads of the proximal connector 82, thereby sleeving the proximal connector 82 over the proximal exterior of the valve containment tube 85. In this manner, the transition piece 75 can be detached from the valve receptacle 85 by simply rotating the proximal connector 82 such that the proximal piece internal threads of the proximal connector 82 disengage from the valve receptacle 85 external threads. Although not shown in the drawings, this example can also achieve the object of the present invention. As mentioned above, the arrangement of the distal axial stiffener 13 and the distal radial stiffener 14 on the inner wall of the distal portion of the handle housing 10, the outer wall of the proximal connector 82 can only be attached to the axial stiffener 13 and the distal radial stiffener 14 during the process of the proximal connector 82 advancing along with the transition connector 75, so as to limit the rotation of the proximal connector 82 and only retract horizontally to the proximal end.

In this example, the distal connector 88 is provided for the distal end of the valve receiving tube 85 to be more securely inserted within the proximal end of the sheath 90, as shown in FIG. 11B. A distal connector 88 is sleeved over the periphery of the distal end of the valve accommodating tube 85 that connects to the proximal end of the sheath sleeve 90. The distal connector 88, like the proximal connector 82, is also cylindrical and may be formed by two semi-cylindrical shells that are symmetrically covered and assembled, with the two sidewalls being fixedly connected by bolts. The two ends of the distal connecting piece 88 are detachably connected with the valve accommodating tube 85 and the sheath sleeve 90 respectively, and the valve accommodating tube 85 and the sheath sleeve 90 are firmly connected together through the distal connecting piece 88.

The present example provides the solution that both ends of the distal connector 88 are detachably connected to the valve accommodating tube 85 and the sheath 90, respectively. Specifically, the outer surface of the middle section of the valve accommodating tube 85 has external threads 855; the proximal inner surface of the distal connector 88 has distal member internal threads 881 that mate with the distal member internal threads 881 of the distal connector 88 via the valve receiving tube 85 external threads 855, thereby sleeving the distal connector 88 outside of the valve receiving tube 85. The distal inner surface of the distal connector 88 has a ring of barbs 882; the outer surface of the sheath tube base 91 at the proximal end of the sheath tube 90 is provided with a ring of tube protrusions 912, the tube protrusions 912 of the sheath tube 90 are hooked on the hook protrusions 882 of the distal connector 88, and thus the distal connector 88 is sleeved outside the proximal end of the sheath tube 90. In this manner, the valve accommodating tube 85 can be detached from the sheath 90 by simply rotating the distal connector 88 to disengage the distal connector internal threads 881 of the distal connector 88 from the valve accommodating tube 85 external threads 855.

As another example (not shown), the valve accommodating tube 85 may have a loop of tube protrusion on the outer surface of the middle section; the inner surface of the proximal end of the distal connector 88 is provided with a circle of hooking protrusions, and the hooking protrusions at the proximal end of the distal connector 88 are hooked by the tube protrusions of the valve accommodating tube 85, so that the distal connector 88 is sleeved outside the valve accommodating tube 85. The outer surface of the proximal end of the sheath tube base 91 of the sheath tube 90 is provided with tube external threads; the distal inner surface of the distal connector 88 is provided with a distal inner thread, and the outer thread of the sheath hub 90 is fittingly coupled to the distal inner thread of the distal connector 88, so that the distal connector 88 is coupled to the proximal outer portion of the sheath hub 90. This also allows the valve-housing tube 85 to be removed from the sheath 90 by simply rotating the distal connector 88 so that the distal connector internal threads of the distal connector 88 disengage from the sheath external threads of the sheath 90. Although not shown in the drawings, this example can also achieve the object of the present invention.

The method of using the transapical mitral valve replacement transporter of the present invention comprises the steps of:

s1, using an external pre-loader, the prosthetic mitral valve is loaded into the valve containment tube 85, the proximal tether 52 (not shown) is crimped inside the trumpet-like structure of the valve cinching tube 35, and the tether 52 is pulled out of the other end of the valve cinching tube 35.

S2, the transition connector 75 is connected with the valve accommodating tube 85 through the proximal connector 82, the valve accommodating tube 85 is connected with the sheath sleeve 90 through the distal connector 88, and the tether 52 passes through the central core tube 51 and extends and is pulled out from the locking head 53 at the proximal end for standby.

S3, rotating the forward push knob 40, wherein the axial groove 41 of the forward push knob 40 is clamped on the axial clamping plate 22 at the proximal end of the middle tube 20, and driving the middle tube 20 to rotate. The middle tube internal thread 21 of the middle tube 20 is in threaded connection with the inner tube external thread 31 of the inner tube 30, and drives the inner tube 30 to move axially and distally. Since the distal end of the inner tube 30 abuts against the valve converging tube 35, the valve converging tube 35 and the inner prosthetic mitral valve are pushed to move linearly towards the distal end together until reaching the distal end of the sheath sleeve 90.

And S4, preparing for releasing the artificial valve. The locking knob on the locking head 53 is rotated to lock the tether 52, so as to prevent the prosthetic valve from impacting the inner wall of the heart due to too much impact force when the prosthetic valve is ejected out of the delivery device in the release process of the prosthetic valve.

S5, the retracting knob 60 is rotated, the retracting knob 60 drives the outer tube 70 to axially move (move towards the proximal end) without rotating, and the outer tube 70 sequentially drives the valve accommodating tube 85 and the sheath sleeve 90 to move towards the proximal end together in a retracting manner, so that the artificial valve is gradually released.

The specific embodiments described herein are merely illustrative of the spirit of the invention. Various modifications or additions may be made to the described embodiments or alternatives may be employed by those skilled in the art without departing from the spirit or ambit of the invention as defined in the appended claims.

Claims

1. A transapical mitral valve replacement conveyor, the transapical mitral valve replacement conveyor having:

an outer tube, the outer surface has outer tube external screw thread;

a sheath sleeve attached to the distal end of the valve-receiving tube;

it is characterized in that the preparation method is characterized in that,

2. The transapical mitral valve replacement transporter of claim 1,

the inner wall of the flange pipe and the outer wall of the circular pipe are bonded by adhesive to further fixedly connect the transition connecting piece to the far end of the outer pipe.

3. The transapical mitral valve replacement transporter of claim 1 or 2,

the inner surface of the proximal end of the valve accommodating tube is provided with an axial groove, the proximal end of the valve accommodating tube is sleeved outside the distal end of the transition connecting piece, and the axial convex block of the transition connecting piece is embedded in the axial groove of the valve accommodating tube to form clamping connection.

4. The transapical mitral valve replacement transporter of claim 1 or 2,

the inner surface of the proximal end of the valve accommodating tube is provided with an axial convex block, the proximal end of the valve accommodating tube is sleeved outside the distal end of the transition connecting piece, and the axial convex block of the valve accommodating tube is embedded in the axial groove of the transition connecting piece to form clamping connection.

5. The transapical mitral valve replacement transporter of claim 1 or 2,

the outer surface of the distal end of the valve accommodating tube is provided with an axial lug;

the inner surface of the proximal end of the sheath pipe sleeve is provided with an axial groove, the proximal end of the sheath pipe sleeve is sleeved outside the distal end of the valve accommodating tube, and the axial convex block of the valve accommodating tube is embedded in the axial groove of the sheath pipe sleeve to form clamping connection.

6. The transapical mitral valve replacement transporter of claim 1 or 2,

the inner surface of the near end of the sheath pipe sleeve is provided with an axial convex block, the near end of the sheath pipe sleeve is sleeved outside the far end of the valve accommodating pipe, and the axial convex block of the sheath pipe sleeve is embedded in the axial groove of the valve accommodating pipe to form clamping connection.

7. The transapical mitral valve replacement conveyor of claim 1 or 2, further comprising:

and two ends of the proximal end connecting piece are respectively detachably connected with the transition connecting piece and the valve containing pipe, and the transition connecting piece and the valve containing pipe are connected together through the proximal end connecting piece.

8. The transapical mitral valve replacement transporter of claim 7,

9. The transapical mitral valve replacement transporter of claim 7,

10. The transapical mitral valve replacement conveyor of claim 1 or 2, further comprising:

11. The transapical mitral valve replacement transporter of claim 10,

12. The transapical mitral valve replacement transporter of claim 10,

the outer surface of the middle section of the valve accommodating tube is provided with a circle of tube bulges;

the inner surface of the near end of the far-end connecting piece is provided with a circle of hooking protrusions, and the hooking protrusions at the near end of the far-end connecting piece are hooked by the tube protrusion of the valve accommodating tube, so that the far-end connecting piece is sleeved outside the valve accommodating tube;

the outer surface of the proximal end of the sheath sleeve is provided with outer pipe threads;

13. The transapical mitral valve replacement transporter of claim 1, wherein the sheath sleeve has:

14. The transapical mitral valve replacement conveyor of claim 1, wherein the distal section interior wall of the handle housing has:

the far-section axial reinforcing ribs and the far-section radial reinforcing ribs can be attached to the outer walls of the transition connecting piece and the near-end connecting piece.

15. The transapical mitral valve replacement conveyor of claim 1, further comprising:

a valve constricting tube, which can be pre-arranged in the valve accommodating tube;

the proximal section of the inner tube penetrates through the inner part of the middle tube, the distal section of the inner tube penetrates through the transition connecting piece in a non-rotatable mode and penetrates through the proximal end of the valve accommodating tube, a cavity sealing washer is arranged at the joint of the distal end of the transition connecting piece and the proximal end of the valve accommodating tube, the cavity sealing washer is sleeved on the periphery of the distal section of the inner tube, the distal end of the inner tube is connected with the valve restraining tube, the outer surface of the proximal end of the inner tube is provided with inner tube external threads, and the inner tube external threads are connected to the inner tube internal threads in a matched mode;

the forward push knob is arranged at the proximal end of the handle shell, and Niu Bika of the forward push knob is buckled and connected to the proximal pipe wall of the middle pipe.

16. The transapical mitral valve replacement conveyor of claim 15, further comprising:

the inner surface of the near end of the inner tube is provided with a circle of near end fixing rings, and the near end of the central core tube is attached to and penetrates through the near end fixing rings of the inner tube;

the utility model discloses a well core pipe, including well core pipe, the outer wall cover of well core pipe is equipped with the solid fixed ring of distal end, the outer wall circumference of the solid fixed ring of distal end is equipped with a rubber circle, the inner wall of inner tube compresses tightly the rubber circle of well core pipe distal end is circled.

17. The transapical mitral valve replacement transporter of claim 16, further comprising:

and the tether is arranged in the central core tube in a penetrating way, and the proximal end of the tether penetrates out of the proximal end of the locking head and can be locked by the locking knob and/or the nut.

18. The transapical mitral valve replacement conveyor of claim 13, wherein the outer sheath has graduations on an outer wall thereof, and a visualization ring at a distal end thereof; the inner wall smoothness and hardness of the inner sheath tube are greater than those of the outer sheath tube.

19. The transapical mitral valve replacement transporter of claim 13,

the sheath tube base of the sheath tube sleeve is internally provided with a sheath sealing gasket, and the far end of the valve accommodating tube is in sealing connection with the near end of the sheath tube sleeve by the aid of the sheath sealing gasket.

20. The transapical mitral valve replacement transporter of claim 15,

21. The transapical mitral valve replacement transporter of claim 15,

22. The transapical mitral valve replacement conveyor of claim 20 or 21,

the forward-push knob is provided with a forward-push gasket which is clamped between the inner wall of the near end of the handle shell and the outer wall of the near end of the middle pipe so as to reduce friction between the handle shell and the middle pipe during rotation.

23. The transapical mitral valve replacement transporter of claim 15,

24. The transapical mitral valve replacement transporter of claim 15,

25. The transapical mitral valve replacement transporter of claim 15,

the inner ring of the radial section of the transition connecting piece is a non-circular shape matched with the shape and size of the outer ring of the radial section of the middle section and the far section of the inner pipe, and the middle section and the far section of the inner pipe are arranged in the transition connecting piece in a penetrating mode and cannot rotate.

26. The transapical mitral valve replacement transporter of claim 15,

the outer ring of the radial section of the middle section and the far section of the inner tube is D-shaped, square-shaped,

A shape, square or polygon;

A shape, square, or polygon.

27. The transapical mitral valve replacement conveyor of claim 15, wherein the proximal section of the inner wall of the handle housing has:

the near-segment axial reinforcing ribs and the near-segment radial reinforcing ribs can be attached to the outer wall of the middle pipe.

28. The transapical mitral valve replacement transporter of claim 1,

the side surface of the far end and/or the side surface of the near end of the withdrawing knob are/is provided with a circle of protrusions for clamping, and the protrusions of the withdrawing knob are embedded in the grooves of the handle shell.

29. The mitral valve replacement transporter of claim 28, wherein the ring of detents is a plurality of uniformly arranged raised posts that are uniformly received in grooves in the handle housing.

30. The transapical mitral valve replacement conveyor of claim 28, wherein the ring of detents is a ring of tabs that snap into a groove in the handle housing.

31. The transapical mitral valve replacement transporter of claim 28, wherein the retraction knob has:

and the two withdrawing washers are arranged on the proximal end surface and the distal end surface of the withdrawing knob, are sleeved outside the outer pipe and are clamped in the bulges.

32. The transapical mitral valve replacement conveyor of claim 31, wherein the projection has a width that is less than a width of the retraction washer, the retraction knob being rotatably connected to the handle housing by the retraction washer.

33. The transapical mitral valve replacement transporter of claim 28, wherein the retraction knob has:

the knob inner thread is arranged on the inner surface of the inner knob ring;

the outer button ring is sleeved outside the inner button ring;

and the support ring is positioned between the inner button ring and the outer button ring and is used for fixedly connecting the inner button ring and the outer button ring.

34. The transapical mitral valve replacement transporter of claim 33,

the inner wall of the handle shell is provided with a plurality of axially arranged positioning plates, and the guide plates can be clamped on the positioning plates.