Transapical mitral valve replacement delivery device

Abstract

The present invention discloses a transapical mitral valve replacement delivery device, which comprises a handle shell, a middle tube, an inner tube, a core tube and a tether in sequence from outside to inside, a forward push knob at the proximal end, and a distal section comprising a handle shell, a retraction knob, an outer tube, a distal end of the middle tube, a distal section of the inner tube, a distal section of the core tube and a distal section of the tether in sequence from outside to inside, and a distal section comprising an outer tube, a transition connector, a valve receiving tube and a sheath sleeve connected in sequence and a valve constriction tube placed in the valve receiving tube in sequence from proximal to distal. The present invention connects the forward push knob to the middle tube by a buckle, so that the forward push knob can stably rotate the middle tube, and the middle tube can stably move the inner tube to push the valve constriction tube toward the distal end for delivery; the transition connector prevents the inner tube from rotating, so that the artificial valve can be delivered linearly toward the distal end during delivery; and by arranging a groove in the square frame of the handle shell, which matches the protrusions on the two end faces of the retraction knob, the retraction knob is limited to improve the stability of the system during the retraction process.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a transapical mitral valve replacement delivery device. Background Art

[0002] Nearly 10 million people in China suffer from valvular heart disease each year, particularly in the mitral valve. Because the mitral valve annulus is not a standard circle, but rather a D-shape, double-layer stents are currently being researched to simultaneously fit the mitral annulus without affecting the sealing performance of the prosthetic valve leaflets. To circumvent the limitations of the transfemoral approach on grip diameter and the potential damage to the body caused by the traditional open-chest approach, mitral valve replacement is currently more often performed through the transapical approach.

[0003] Patent application CN107750150A provides a device and method for delivering, repositioning and retrieving a transcatheter prosthetic valve, but the delivery knob of the device has the risk of idling of the inner tube delivery and system instability causing delivery failure. Summary of the Invention

[0004] The present invention aims to provide a new transapical mitral valve replacement delivery device to solve the technical problems in the prior art such as idling of the inner tube during delivery and system instability leading to delivery failure.

[0005] The transapical mitral valve replacement delivery device of the present invention has:

[0006] A valve constrictor tube, in which an artificial valve can be placed in compression;

[0007] a middle tube, wherein the inner surface of the middle tube has an inner tube thread;

[0008] an inner tube, the proximal section of which is passed through the interior of the middle tube, the distal end of the inner tube abuts against the proximal end of the valve constrictor tube, the proximal end outer surface of the inner tube having an inner tube external thread, the inner tube external thread being cooperatively connected to the inner thread of the middle tube, and the rotation of the middle tube can drive the inner tube to push the valve constrictor tube toward the distal end;

[0009] A forward push knob, the knob wall of the forward push knob is buckled and connected to the proximal tube wall of the middle tube, and the middle tube is rotated by circumferentially rotating the forward push knob.

[0010] The present invention is connected to the middle tube by a buckle through the forward push knob, so that the forward push knob can stably rotate the middle tube and the middle tube can stably move the inner tube to push the valve convergence tube toward the distal end.

[0011] Preferably, the transapical mitral valve replacement delivery device further comprises:

[0012] a handle shell, sleeved on the outside of the middle tube, and the forward push knob is screwed on the proximal end of the handle shell;

[0013] A transition connector is located at the distal end of the handle housing, and the distal section of the inner tube is non-rotatably inserted into the transition connector.

[0014] The present invention prevents the inner tube from rotating during the delivery process through a transition connector, so that the artificial valve can be delivered linearly toward the distal end.

[0015] Preferably,

[0016] The distal inner wall of the forward push knob is provided with a plurality of circumferential protrusions;

[0017] The proximal outer wall of the handle shell has 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 screwed to the proximal end of the handle shell.

[0018] Preferably,

[0019] The distal inner wall of the forward push knob is provided with a plurality of circumferential concave rings;

[0020] The proximal outer wall of the handle shell has a plurality of corresponding annular convex rings, which are embedded in the annular concave ring of the front push knob through the annular convex ring of the handle shell, so that the front push knob is screwed to the proximal end of the handle shell.

[0021] Preferably,

[0022] The forward push knob has a forward push washer, which is sandwiched between the proximal inner wall of the handle shell and the proximal outer wall of the middle tube to reduce friction between the handle shell and the middle tube during rotation.

[0023] Preferably,

[0024] The proximal inner wall of the forward push knob has at least one axial groove;

[0025] The proximal outer wall of the middle tube has at least one axial clamping plate; the axial clamping plate of the middle tube is embedded in the axial groove of the forward push knob, so that the circumferential rotation of the forward push knob drives the middle tube to rotate.

[0026] Preferably,

[0027] The proximal inner wall of the forward push knob has at least one axial clamping plate;

[0028] The proximal wall of the middle tube has at least one axial groove; the axial clamping plate of the forward push knob is embedded in the axial groove of the middle tube, so that the circumferential rotation of the forward push knob drives the middle tube to rotate.

[0029] Preferably,

[0030] The outer rings of the radial cross sections of the middle and distal sections of the inner tube are non-circular;

[0031] The inner circle of the radial cross section of the transition connector is non-circular and matches the shape and size of the outer circle of the radial cross section of the middle and distal sections of the inner tube. The middle and distal sections of the inner tube are inserted into the transition connector and cannot rotate.

[0032] Preferably,

[0033] The outer ring of the radial cross section of the middle and distal sections of the inner tube is D-shaped, square-shaped, Shape, square or polygonal;

[0034] The inner ring of the radial cross section of the transition connector is D-shaped, square-shaped, Shape, square or polygonal.

[0035] Preferably, the inner wall of the proximal section of the handle shell has:

[0036] A plurality of proximal axial reinforcing ribs, axially fixed to the proximal inner wall of the handle shell;

[0037] A plurality of proximal radial reinforcing ribs, radially fixed to the proximal inner wall of the handle shell;

[0038] The proximal axial reinforcing ribs and the proximal radial reinforcing ribs can be attached to the outer wall of the middle tube to increase stability when the middle tube is rotated.

[0039] Preferably, the transapical mitral valve replacement delivery device further comprises:

[0040] A valve accommodating tube, in which the valve constricting tube is pre-installed, the distal end of the transition connector is connected to the proximal end of the valve accommodating tube, the distal section of the inner tube is inserted into the proximal end of the valve accommodating tube, a cavity sealing gasket is provided at the connection between the distal end of the transition connector and the proximal end of the valve accommodating tube, and the cavity sealing gasket is sleeved around the outer periphery of the distal section of the inner tube;

[0041] A sheath sleeve, wherein the proximal end of the sheath sleeve has a sheath sealing gasket, and the proximal end of the sheath sleeve is sealed and connected to the distal end of the valve receiving tube. When the middle tube rotates, it can drive the inner tube to push the valve collecting tube to transport the artificial valve toward the distal end along the central axis of the sheath sleeve.

[0042] Preferably, the sheath tube sleeve has:

[0043] a sheath base located at the proximal end of the sheath sleeve, wherein the sheath base of the sheath sleeve is connected to the distal end of the valve accommodating tube;

[0044] an inner sheath tube, wherein the proximal end of the inner sheath tube is connected to the distal end of the sheath tube base;

[0045] An outer sheath is sleeved outside the inner sheath, and the proximal end of the outer sheath is connected to the distal end of the sheath base.

[0046] Preferably, the transapical mitral valve replacement delivery device further comprises:

[0047] an outer tube, disposed between the distal end of the handle housing and the distal end of the middle tube, the outer surface of the outer tube having an outer tube external thread, the proximal end of the transition connector being fixedly connected to the distal end of the outer tube;

[0048] A retraction knob is clamped in the open cavity of the distal end of the handle shell. The inner surface of the retraction knob has an internal knob thread, and the internal knob thread is connected to the external thread of the outer tube. Rotating the retraction knob drives the outer tube and the valve receiving tube and the sheath sleeve connected to the outer tube to retract toward the proximal end to release the artificial valve.

[0049] Preferably, the transapical mitral valve replacement delivery device further comprises:

[0050] a central core tube, which is inserted into the inner tube, and the proximal end of the central core tube passes through the proximal end of the forward push knob;

[0051] The inner surface of the proximal end of the inner tube is provided with a proximal fixing ring, and the proximal end of the core tube is fitted into the proximal fixing ring of the inner tube to provide support for the core tube;

[0052] The distal outer wall of the core tube is sleeved with a distal fixing ring, and the outer wall of the distal fixing ring is circumferentially provided with a rubber ring. The inner wall of the inner tube is pressed tightly against the rubber ring at the distal end of the core tube to seal and isolate the artificial valve from the outside world.

[0053] Preferably, the transapical mitral valve replacement delivery device further comprises:

[0054] a locking head, wherein the distal end of the locking head is movably connected to the proximal end of the forward push knob, a locking knob with a sealing ring is provided on the middle section of the locking head, a nut is provided at the proximal end of the locking head, and the proximal end of the core tube is fixed within the distal end of the locking head;

[0055] A tether is passed through the core tube, the distal end of the tether is connected to the artificial valve, and the proximal end of the tether passes through the proximal end of the locking head and can be locked by the locking knob and / or the nut.

[0056] Preferably,

[0057] The proximal outer wall of the valve constrictor tube has an outer step opening;

[0058] The inner wall of the distal end of the inner tube has an inner step opening, and the outer step opening of the valve constrictor tube is matched and snapped onto the inner step opening of the inner tube to form abutment.

[0059] Preferably, the transapical mitral valve replacement delivery device has:

[0060] a proximal connector, both ends of which are detachably connected to the transition connector and the valve-containing tube, respectively, and the transition connector and the valve-containing tube are connected together through the proximal connector;

[0061] A distal connector has two ends detachably connected to the valve accommodating tube and the sheath sleeve, and the valve accommodating tube and the sheath sleeve are connected together through the distal connector.

[0062] Preferably,

[0063] The interior of the valve accommodating tube is a trumpet-shaped structure with an opening toward the distal end. When the artificial valve is pre-folded, the proximal end of the artificial valve is folded into the trumpet-shaped structure, and the rest of the valve is located in a larger space in the valve accommodating tube.

[0064] Another objective of the present invention is to address the technical problem in the prior art of the sheath sleeve withdrawal process, where the withdrawal knob does not match the shape of the opening in the handle housing, causing unstable shaking during rotation. This causes the outer tube inserted into the withdrawal knob, as well as the valve-receiving tube and sheath sleeve connected to the outer tube, to shake. The purpose is to provide a new technical solution that can stably withdraw the sheath sleeve and other components. The transapical mitral valve replacement delivery device described in this technical solution can stably withdraw the sheath sleeve and other components after the artificial valve is delivered to the target location.

[0065] The transapical mitral valve replacement delivery device of the present invention has:

[0066] An outer tube with an outer tube external thread on the outer surface, a valve accommodating tube and a sheath sleeve are sequentially connected from the proximal end to the distal end;

[0067] a handle shell, wherein a distal end of the handle shell is sleeved outside the outer tube;

[0068] a retraction knob disposed in the open cavity of the distal end of the handle housing, the inner surface of the retraction knob having an internal knob thread connected to the external thread of the outer tube, and rotating the retraction knob causes the outer tube and the valve receiving tube and the sheath sleeve connected thereto to retract toward the proximal end to release the artificial valve;

[0069] in,

[0070] The opening of the handle shell is a square frame that passes through the handle shell, and the square frame is provided with a circle of grooves for locking on the distal frame wall and / or the proximal frame wall;

[0071] The retraction knob is provided with a circle of protrusions for positioning on the distal side surface and / or the proximal side surface, and the protrusions of the retraction knob are embedded in the grooves of the handle shell, thereby limiting the retraction knob.

[0072] The present invention provides a locking groove in the square frame of the handle shell, and corresponding protrusions are provided on the two end surfaces of the retraction knob. The protrusions of the retraction knob are embedded in the grooves of the handle shell to limit the retraction knob, thereby improving the stability of the retraction knob during the retraction process, as well as the stability of the valve containing tube and sheath tube connected together with the outer tube inserted in the retraction knob during the retraction process.

[0073] Preferably, the circle of protrusions for locking is a plurality of protrusion columns evenly arranged in a circle, and the protrusion columns are evenly embedded in the grooves of the handle shell.

[0074] Preferably, the circle of protrusions for locking is a circle of convex rings, and the convex rings are embedded in the grooves of the handle shell.

[0075] Preferably, the retracement knob has:

[0076] Two retraction washers are arranged on the proximal and distal surfaces of the retraction knob, sleeved outside the outer tube and clamped in the protrusion, for reducing friction during rotation and improving stability during rotation.

[0077] The width of the protrusion is smaller than the width of the retraction washer, and the retraction knob is rotatably connected to the handle shell through the retraction washer.

[0078] Preferably, the retracement knob has:

[0079] An inner button ring, wherein the inner thread of the knob is provided on the inner surface of the inner button ring;

[0080] An outer button ring, sleeved outside the inner button ring;

[0081] The support ring is located between the inner button ring and the outer button ring and is used to fix the inner button ring and the outer button ring. This design can increase the outer circumference of the outer button ring and facilitate rotation without increasing material and weight.

[0082] Preferably,

[0083] The outer wall of the proximal end of the outer tube is provided with a plurality of axially arranged guide plates;

[0084] 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 directional plates, so that the outer tube can be withdrawn without rotation.

[0085] Preferably, the transapical mitral valve replacement delivery device further comprises:

[0086] a valve constrictor tube, in which an artificial valve can be compressed and placed, and the valve constrictor tube can be pre-placed in the valve accommodating tube;

[0087] a middle tube, the middle tube being inserted into the handle shell, and the inner surface of the middle tube having an inner tube thread;

[0088] an inner tube, the proximal portion of which is passed through the interior of the middle tube, and the distal portion of which is passed through the proximal end of the valve-receiving tube, the distal end of the inner tube being connected to the valve-receiving tube, the proximal end outer surface of the inner tube having an inner tube external thread, the inner tube external thread being cooperatively connected to the inner thread of the middle tube, and the rotation of the middle tube can drive the inner tube to transport the artificial valve toward the distal end;

[0089] a transition piece, wherein the proximal end of the transition piece is fixedly connected to the distal end of the outer tube, the distal end of the transition piece is connected to the proximal end of the valve-containing tube, a cavity sealing gasket is provided at the connection between the distal end of the transition 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, the outer tube and the valve-containing tube are connected together by the transition piece, and the distal section of the inner tube is non-rotatably inserted into the transition piece;

[0090] A forward push knob is provided at the proximal end of the handle shell. The button wall of the forward push knob is snap-connected to the proximal wall of the middle tube. The circumferential rotation of the forward push knob drives the middle tube to rotate.

[0091] Preferably, the transapical mitral valve replacement delivery device further comprises:

[0092] a central core tube, which is inserted into the inner tube, and the proximal end of the central core tube passes through the proximal end of the forward push knob;

[0093] The inner surface of the proximal end of the inner tube is provided with a proximal fixing ring, and the proximal end of the core tube is fitted into the proximal fixing ring of the inner tube to provide support for the core tube;

[0094] The distal outer wall of the core tube is sleeved with a distal fixing ring, and the outer wall of the distal fixing ring is circumferentially provided with a rubber ring. The inner wall of the inner tube is pressed tightly against the rubber ring at the distal end of the core tube to seal and isolate the artificial valve from the outside world.

[0095] Preferably, the transapical mitral valve replacement delivery device further comprises:

[0096] a locking head, wherein the distal end of the locking head is movably connected to the proximal end of the forward push knob, a locking knob with a sealing ring is provided on the middle section of the locking head, a nut is provided at the proximal end of the locking head, and the proximal end of the core tube is fixed within the distal end of the locking head;

[0097] A tether is passed through the core tube, the distal end of the tether is connected to the artificial valve, and the proximal end of the tether passes through the proximal end of the locking head and can be locked by the locking knob and / or the nut.

[0098] Preferably, the transapical mitral valve replacement delivery device has:

[0099] a proximal connector, both ends of which are detachably connected to the transition connector and the valve-containing tube, respectively, and the transition connector and the valve-containing tube are connected together through the proximal connector;

[0100] A distal connector has two ends detachably connected to the valve accommodating tube and the sheath sleeve, and the valve accommodating tube and the sheath sleeve are connected together through the distal connector.

[0101] Preferably,

[0102] The outer tube has a wall through which a tube hole is penetrated;

[0103] The distal end of the handle shell is penetrated by a shell hole, and the shell hole corresponds to the position of the tube hole;

[0104] The outer wall of the inner tube is provided with a scale, and the scale on the inner tube can be viewed through the shell hole and the tube hole to determine the conveying position.

[0105] Preferably, the outer surface of the valve accommodating tube has external reinforcing ribs, and the external reinforcing ribs have indicating marks.

[0106] Preferably, the sheath tube sleeve has:

[0107] a sheath base located at the proximal end of the sheath sleeve, wherein the sheath base of the sheath sleeve has a sheath sealing gasket, and the distal end of the valve receiving tube is sealed and connected to the sheath sleeve via the sheath sealing gasket;

[0108] an inner sheath tube, wherein the proximal end of the inner sheath tube is connected to the distal end of the sheath tube base;

[0109] An outer sheath is sleeved outside the inner sheath, and the proximal end of the outer sheath is connected to the distal end of the sheath base.

[0110] The present invention addresses the technical problems in the prior art of unstable connection between the outer tube and the valve-receiving tube, which can easily cause the valve-receiving tube to fall off the outer tube during withdrawal. The present invention aims to provide a technical solution for stably connecting the outer tube and the valve-receiving tube. The transapical mitral valve replacement delivery device of this solution has the following features:

[0111] An outer tube, the outer surface of which has an outer tube external thread;

[0112] a handle shell, wherein a distal end of the handle shell is sleeved outside the outer tube;

[0113] a retraction knob disposed in the open cavity of the distal end of the handle housing, wherein the inner surface of the retraction knob has an internal knob thread, and the internal knob thread is connected to the external thread of the outer tube;

[0114] a transition connector, the proximal end of which is fixedly connected to the distal end of the outer tube;

[0115] a valve accommodating tube, the proximal end of which is connected to the distal end of the transition piece;

[0116] a sheath sleeve connected to the distal end of the valve-containing tube;

[0117] Rotating the retraction knob drives the outer tube, the valve receiving tube connected to the outer tube, and the sheath sleeve to retract toward the proximal end to release the artificial valve;

[0118] in,

[0119] The distal end of the outer tube is a circular tube, and the outer wall of the circular tube has a pair of cut-wall holes;

[0120] The proximal end of the transition connector is a flange pipe, which is passed through the outside of the circular tube. A pair of through-wall holes are provided at corresponding positions on the flange pipe. A pair of fixing rods are respectively passed through the through-holes of the transition connector and the cut holes of the outer tube, thereby fixing the transition connector to the distal end of the outer tube.

[0121] The present invention provides a pair of cutouts on the outer tube, and simultaneously provides a transition connector that is detachably connected to the proximal end of the valve containing tube, and provides corresponding perforations on the transition connector. Then, a fixing rod is passed through the perforations of the transition connector and the cutouts of the outer tube, so that the outer tube and the valve containing tube are firmly connected together by the firm connection between the transition connector and the outer tube, and can be easily disassembled during disassembly.

[0122] Preferably,

[0123] The inner wall of the flange pipe and the outer wall of the circular pipe are bonded with adhesive to further stably fix the transition connector to the distal end of the outer pipe and seal the interior of the transition connector.

[0124] Preferably,

[0125] The distal outer surface of the transition connector has an axial protrusion;

[0126] The inner surface of the proximal end of the valve accommodating tube has an axial groove, and the proximal end of the valve accommodating tube is sleeved on the outside of the distal end of the transition connector. The axial protrusion of the transition connector is embedded in the axial groove of the valve accommodating tube to form a snap connection to prevent relative rotation.

[0127] Preferably,

[0128] The distal outer surface of the transition piece has an axial groove;

[0129] The inner surface of the proximal end of the valve accommodating tube has an axial protrusion, and the proximal end of the valve accommodating tube is sleeved on the outside of the distal end of the transition connector. The axial protrusion of the valve accommodating tube is embedded in the axial groove of the transition connector to form a clamping connection to prevent relative rotation.

[0130] Preferably,

[0131] The distal outer surface of the valve accommodating tube is provided with an axial protrusion;

[0132] The inner surface of the proximal end of the sheath sleeve has an axial groove, and the proximal end of the sheath sleeve is sleeved on the outside of the distal end of the valve accommodating tube. The axial protrusion of the valve accommodating tube is embedded in the axial groove of the sheath sleeve to form a clamping connection to prevent relative rotation.

[0133] Preferably,

[0134] The distal outer surface of the valve accommodating tube has an axial groove;

[0135] The inner surface of the proximal end of the sheath sleeve has an axial protrusion, and the proximal end of the sheath sleeve is sleeved on the outside of the distal end of the valve accommodating tube. The axial protrusion of the sheath sleeve is embedded in the axial groove of the valve accommodating tube to form a clamping connection to prevent relative rotation.

[0136] Preferably, the transapical mitral valve replacement delivery device further comprises:

[0137] A proximal connector has two ends detachably connected to the transition connector and the valve accommodating tube, and the transition connector and the valve accommodating tube are connected together through the proximal connector.

[0138] Preferably,

[0139] The outer surface of the middle section of the transition connector has a transition external thread;

[0140] The proximal inner surface of the proximal connecting piece has a proximal internal thread, and the transition external thread of the transition connecting piece is matched with the proximal internal thread of the proximal connecting piece, so that the proximal connecting piece is sleeved on the outside of the transition connecting piece;

[0141] The proximal outer surface of the valve accommodating tube is provided with a circle of tube protrusions;

[0142] The distal inner surface of the proximal connector has a circle of hooks, and the tube protrusion of the valve accommodating tube is hooked on the hooks of the proximal connector, so that the proximal connector is sleeved on the proximal exterior of the valve accommodating tube.

[0143] Preferably,

[0144] The outer surface of the middle section of the transition connector is provided with a circle of pipe protrusions;

[0145] The inner surface of the proximal end of the proximal connector has a circle of hook protrusions, and the pipe protrusion of the transition connector is hooked on the hook protrusion of the proximal end of the proximal connector, so that the proximal connector is sleeved on the outside of the transition connector;

[0146] The proximal outer surface of the valve accommodating tube has an external tube thread;

[0147] The distal inner surface of the proximal connector has a proximal inner thread, and the outer thread of the valve accommodating tube is fitted and connected to the proximal inner thread of the proximal connector, thereby sleeved on the proximal exterior of the valve accommodating tube.

[0148] Preferably, the transapical mitral valve replacement delivery device further comprises:

[0149] A distal connector has two ends detachably connected to the valve accommodating tube and the sheath sleeve, and the valve accommodating tube and the sheath sleeve are connected together through the distal connector.

[0150] Preferably,

[0151] The outer surface of the middle section of the valve accommodating tube has an external tube thread;

[0152] The proximal inner surface of the distal connector has a distal internal thread, and the distal connector is connected to the valve accommodating tube through the external thread of the valve accommodating tube and the distal internal thread of the distal connector, so that the distal connector is sleeved on the outside of the valve accommodating tube;

[0153] The distal inner surface of the distal connecting piece has a circle of hooks and protrusions;

[0154] The outer surface of the proximal end of the sheath sleeve is provided with a circle of tube protrusions, and the tube protrusions of the sheath sleeve are hooked on the hook protrusions of the distal connector, so that the distal connector is sleeved on the proximal end of the sheath sleeve.

[0155] Preferably,

[0156] The outer surface of the middle section of the valve accommodating tube is provided with a circle of tube protrusions;

[0157] The inner surface of the proximal end of the distal connector has a circle of hook convexities, and the tube convexities of the valve accommodating tube are hooked on the hook convexities at the proximal end of the distal connector, so that the distal connector is sleeved on the outside of the valve accommodating tube;

[0158] The outer surface of the proximal end of the sheath tube sleeve has an external tube thread;

[0159] The distal inner surface of the distal connector has a distal inner thread, and the outer thread of the sheath sleeve is fitted and connected to the distal inner thread of the distal connector, thereby sleeved on the proximal exterior of the sheath sleeve.

[0160] Preferably, the sheath tube sleeve has:

[0161] a sheath base located at the proximal end of the sheath sleeve, wherein the sheath base of the sheath sleeve is connected to the distal end of the valve accommodating tube;

[0162] an inner sheath tube, wherein the proximal end of the inner sheath tube is connected to the distal end of the sheath tube base;

[0163] An outer sheath is sleeved outside the inner sheath, and the proximal end of the outer sheath is connected to the distal end of the sheath base.

[0164] Preferably, the inner wall of the distal section of the handle shell has:

[0165] A plurality of distal axial reinforcing ribs, axially fixed to the distal inner wall of the handle shell;

[0166] A plurality of distal radial reinforcing ribs, radially fixed to the distal inner wall of the handle shell;

[0167] The distal axial reinforcement ribs and the distal radial reinforcement ribs can be fitted onto outer walls of the transition connector and the proximal connector, so that the transition connector and the proximal connector can be horizontally retracted without rotating.

[0168] Preferably, the transapical mitral valve replacement delivery device further comprises:

[0169] a valve constrictor tube, in which an artificial valve can be compressed and placed, and the valve constrictor tube can be pre-placed in the valve accommodating tube;

[0170] a middle tube, the middle tube being inserted into the handle shell, and the inner surface of the middle tube having an inner tube thread;

[0171] An inner tube, the proximal section of which is passed through the interior of the middle tube, and the distal section of which is non-rotatably passed through the transition connector and passed through the proximal end of the valve-containing tube. A cavity sealing gasket is provided at the connection between the distal end of the transition connector 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. The distal end of the inner tube is connected to the valve collecting tube. The proximal outer surface of the inner tube has an inner tube external thread, and the inner tube external thread is cooperatively connected to the inner thread of the middle tube. The rotation of the middle tube can drive the inner tube to transport the artificial valve toward the distal end.

[0172] A forward push knob is provided at the proximal end of the handle shell. The button wall of the forward push knob is snap-connected to the proximal wall of the middle tube. The circumferential rotation of the forward push knob drives the middle tube to rotate.

[0173] Preferably, the transapical mitral valve replacement delivery device further comprises:

[0174] a central core tube, which is inserted into the inner tube, and the proximal end of the central core tube passes through the proximal end of the forward push knob;

[0175] The inner surface of the proximal end of the inner tube is provided with a proximal fixing ring, and the proximal end of the core tube is fitted into the proximal fixing ring of the inner tube to provide support for the core tube;

[0176] The distal outer wall of the core tube is sleeved with a distal fixing ring, and the outer wall of the distal fixing ring is circumferentially provided with a rubber ring. The inner wall of the inner tube is pressed tightly against the rubber ring at the distal end of the core tube to seal and isolate the artificial valve from the outside world.

[0177] Preferably, the transapical mitral valve replacement delivery device further comprises:

[0178] a locking head, wherein the distal end of the locking head is movably connected to the proximal end of the forward push knob, a locking knob with a sealing ring is provided on the middle section of the locking head, a nut is provided at the proximal end of the locking head, and the proximal end of the core tube is fixed within the distal end of the locking head;

[0179] A tether is passed through the core tube, the distal end of the tether is connected to the artificial valve, and the proximal end of the tether passes through the proximal end of the locking head and can be locked by the locking knob and / or the nut.

[0180] Preferably, the outer wall of the outer sheath tube has a scale, and the retraction end point can be determined according to the scale. The distal end of the outer sheath tube has a developing ring, and the retraction position is determined according to the developing ring and the scale; the inner wall of the inner sheath tube is smoother and harder than that of the outer sheath tube.

[0181] Preferably,

[0182] A sheath sealing gasket is provided in the sheath base of the sheath sleeve, and the distal end of the valve accommodating tube is sealed and connected to the proximal end of the sheath sleeve via the sheath sealing gasket.

[0183] Compared with the existing technology, the present invention has the following beneficial effects:

[0184] 1) The present invention is connected to the middle tube by a buckle through the forward push knob, so that the forward push knob can stably rotate the middle tube, so that the middle tube can stably move the inner tube to push the valve constrictor tube toward the distal end.

[0185] 2) The present invention adopts a non-circular and shape-matching design of the middle and distal sections of the inner tube and the inner surface of the transition connector. The transition connector prevents the inner tube from rotating, and the artificial valve can be transported straight toward the distal end during the transportation process.

[0186] 3) The present invention provides a locking groove in the square frame of the handle shell, and provides corresponding protrusions on both end surfaces of the retraction knob. The protrusions of the retraction knob are embedded in the grooves of the handle shell to limit the retraction knob, thereby improving the stability of the retraction knob during the retraction process, as well as the stability of the valve containing tube and sheath tube connected together with the outer tube inserted in the retraction knob during the retraction process.

[0187] 4) The present invention provides a pair of cutouts in the outer tube and corresponding perforations in the transition piece. Fixing rods are then inserted through the perforations in the transition piece and the cutouts in the outer tube. This secure connection between the transition piece and the outer tube securely connects the outer tube to the valve-receiving tube, allowing for easy removal. Furthermore, adhesive is used to bond the inner wall of the flange tube to the outer wall of the circular tube, stably securing the transition piece to the distal end of the outer tube and sealing the interior of the transition piece.

[0188] 5) The present invention provides a cavity sealing gasket at the connection between the distal end of the transition connector and the proximal end of the valve containing tube, arranges a sheath sealing gasket between the valve containing tube and the sheath base of the sheath sleeve, arranges a rubber ring on the distal fixing ring, and arranges a locking knob with a sealing ring on the locking head, thereby sealing and isolating all possible potential channels from the outside world, thereby further improving the sealing performance of the conveyor system. BRIEF DESCRIPTION OF THE DRAWINGS

[0189] Figure 1A It is a side structural schematic diagram of the transapical mitral valve replacement delivery device of the present invention;

[0190] Figure 1B It is a schematic diagram of the exploded structure of the transapical mitral valve replacement delivery device of the present invention;

[0191] Figure 1C is a schematic cross-sectional view of the transapical mitral valve replacement delivery device of the present invention;

[0192] Figure 1D This is a side structural diagram of the transapical mitral valve replacement delivery device of the present invention without the handle shell 10;

[0193] Figure 1E Schematic diagram of the three-dimensional structure of the internal components of the distal section of the transapical mitral valve replacement delivery device of the present invention;

[0194] Figure 2A This is a schematic diagram of the internal structure of half of the handle shell 10 of the present invention;

[0195] Figure 2B This is a schematic diagram of the internal structure of the handle shell 10 provided with the inner tube 30 of the present invention after being disassembled;

[0196] Figure 3 Schematic diagram of the structure of the middle tube 20 of the present invention;

[0197] Figures 4A-4B This is a schematic structural diagram of the connection relationship between the inner tube 30 and the transition connector 75 of the present invention;

[0198] Figures 4C-4D Schematic diagram of the connection between the inner tube 30 and the valve constrictor tube 35 of the present invention;

[0199] Figures 5A-5B Schematic diagram of the structure of the push-forward knob 40 of the present invention;

[0200] Figure 6 Schematic diagram of the structure of the core tube 51 and the locking head 53 of the present invention;

[0201] Figure 7 Schematic diagram of the structure of the outer tube 70 and the retraction knob 60 of the present invention;

[0202] Figure 8 Schematic diagram of the structure of the retraction knob 60 of the present invention;

[0203] Figures 9A to 9D FIG. 1 is a diagram illustrating the connection relationship between the transition connector 70 , the valve receiving tube 85 , and the valve collecting tube 35 of the present invention;

[0204] Figure 10A Schematic diagram of the side structure of the sheath tube sleeve 90;

[0205] Figure 10B Schematic diagram of the cross-sectional structure of the sheath tube sleeve 90;

[0206] Figure 11A is a schematic diagram of the three-dimensional structure of the proximal connecting member 82;

[0207] Figure 11B It is a schematic diagram of the three-dimensional structure of the distal connecting member 88. DETAILED DESCRIPTION

[0208] The following describes the embodiments of the present invention through specific examples. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments. The details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the following embodiments and features in the embodiments can be combined with each other unless they conflict.

[0209] In the field of interventional medical devices, "distal end" and "distal segment" are defined as the end or segment away from the operator during surgery, and "proximal end" and "proximal segment" are defined as the end or segment close to the operator during surgery.

[0210] In the present invention, unless otherwise expressly specified or limited, the terms "installed," "connected," "connected," "fixed," etc. should be understood in a broad sense. For example, they may refer to fixed connection, detachable connection, or integration; mechanical connection, electrical connection, or communication connection; direct connection or indirect connection through an intermediate medium; internal communication between two elements or interaction between two elements, unless otherwise expressly specified or limited. Those skilled in the art will be able to understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0211] In the present invention, "axial" generally refers to the axis between the distal and proximal ends, and can be understood as the direction of the central axis or a direction parallel to the central axis. Of course, sometimes "axial" can also refer to the axis of the axisymmetric element itself. "Radial" refers to the direction perpendicular to the "axial".

[0212] like Figures 1A to 1EThe figure shows a transapical mitral valve replacement delivery device of the present invention. The proximal section of the transapical mitral valve replacement delivery device of the present invention comprises, from outside to inside, a handle housing 10, a middle tube 20, an inner tube 30, a core tube 51, and a tether 52. The proximal end is also provided with a push knob 40 and a locking head 53. The distal section comprises, 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 end of the inner tube 30, the distal end of the core tube 51, and the distal end of the tether 52. The distal section comprises, from proximal to distal, the outer tube 70, a transition connector 75, a valve-receiving tube 85, and a sheath sleeve 90, which are connected in sequence. The proximal connector 82 detachably connects the transition connector 75 and the valve-receiving tube 85, the distal connector 88 detachably connects the valve-receiving tube 85 and the sheath sleeve 90, and the valve constrictor 35 connected to the distal end of the inner tube 30 and placed within the valve-receiving tube 85.

[0213] like Figure 2A and 2B As shown, the handle shell 10 of this example can be formed by two symmetrical half shells that are axially symmetrically covered to form a whole. The edges of the shells can have a plurality of screw holes, which are screwed into the screw holes at symmetrical positions of the two half shells to cover and connect them. The inner wall of the proximal section of the handle shell 10 has a plurality of proximal axial reinforcing ribs 11, which are axially fixed to the inner wall of the proximal section of the handle shell; a plurality of proximal radial reinforcing ribs 12 are radially fixed to the inner wall of the proximal section of the handle shell; the proximal axial reinforcing ribs 11 and the proximal radial reinforcing ribs 12 can be attached to the outer wall of the middle tube 20 to increase stability when the middle tube 20 is rotated (see the examples described below for details). The distal inner wall of the handle shell 10 has a number of distal axial reinforcing ribs 13, which are axially fixed to the distal inner wall of the handle shell 10; a number of distal radial reinforcing ribs 14 are radially fixed to the distal inner wall of the handle shell 10; the distal axial reinforcing ribs 13 and the distal radial reinforcing ribs 14 can fit on the outer walls of the transition connector 75 and the proximal connector 82, so that the transition connector 75 and the proximal connector 82 can be retracted horizontally and linearly without rotating (see the examples described later for details). The proximal outer wall of the handle shell 10 has a number of corresponding annular concave rings 15 or annular convex rings (see the examples described later for details). The distal end of the handle shell 10 is provided with an open cavity, which is surrounded by a square frame 16, and the square frame 16 forms the open cavity. The square frame 16 is provided with a circle of locking grooves 161 on the distal frame wall and / or the proximal frame wall (the functions of the frame 16 and the groove 161 are specifically referred to the example of the retraction knob 60 described later). The distal end of the handle housing is penetrated by a housing hole 17, which allows viewing of the scale on the inner tube 30 to determine the delivery position. The distal inner wall of the handle housing 10 is provided with several axially arranged positioning plates 18. These positioning plates 18 engage with guide plates 72 at the proximal end of the outer tube 70 to prevent the outer tube 70 from rotating, ensuring that the outer tube 70 can only be moved proximally by the retraction knob.

[0214] like Figure 3As shown, in this example, a middle tube 20 is passed closely inside the handle shell 10. The middle tube 20 is passed through the handle shell 10 and can rotate inside the handle shell 10. The proximal end of the middle tube 20 is snap-connected with the proximal push knob 40, and the distal end can extend all the way to the proximal end of the outer tube 70. Of course, it is also feasible not to extend to the proximal end of the outer tube 70. The inner surface of the middle tube 20 has a middle tube internal thread 21, which can be matched and connected with the inner tube external thread on the outer surface of the inner tube 30. The proximal outer wall of the middle tube 20 has at least one axial clamping plate 22; the axial clamping plate 22 of the middle tube 20 is embedded in the axial groove of the push knob 40, so that the circumferential rotation of the push knob 40 drives the middle tube 20 to rotate. Another example is that the proximal outer wall of the middle tube 20 has at least one axial groove; the axial retaining plate of the forward push knob 40 is embedded in the axial groove of the middle tube 20, so that the circumferential rotation of the forward push knob 40 drives the rotation of the middle tube 20. This example is not shown. When the middle tube 20 rotates, the outer wall can fit on the proximal axial reinforcement ribs 11 and proximal radial reinforcement ribs 12 of the handle housing 10, providing support. This prevents the middle tube 20 from shaking due to insufficient support from the middle section due to its excessive length.

[0215] like Figure 1C 、 Figure 2B and Figures 4A-4B As shown, in this example, the proximal section of the inner tube 30 is inserted into the interior of the middle tube 20. The middle section of the inner tube 30 sequentially passes through the outer tube 70 and the transition piece 75 until its distal end is inserted into the proximal end of the valve-receiving tube 85. The distal end of the inner tube 30 abuts the proximal end of the valve-receiving tube 35 pre-installed in the valve-receiving tube 85. The proximal outer surface of the inner tube 30 has inner tube external threads 31, which engage with the inner tube internal threads 21 of the middle tube 20. Rotation of the middle tube 20 drives the inner tube 30 to push the valve-receiving tube 85 distally. A scale is provided on the outer wall of the inner tube 30, allowing the progress of delivery to be monitored through the housing hole 17 of the distal end of the handle housing 10. To prevent the inner tube 30 from rotating and being carried by the rotating middle tube 20 in a linear motion toward the distal end, the outer radial cross-sections of the middle and distal sections of the inner tube 30 (the sections excluding the proximal external threads) are designed to be non-circular. The inner circle of the radial cross section of the transition piece 75 is set to a non-circular shape that matches the shape and size of the outer circle of the radial cross section of the middle and distal sections of the inner tube 30. This design can prevent the middle and distal sections of the inner tube 30 from rotating while passing through the transition piece 75. The transition piece 75 restricts the inner tube 30 from rotating and can only move in a straight line toward the distal end (see the examples below for details). The outer circle of the radial cross section of the middle and distal sections of the inner tube 30 can be designed to be D-shaped, square-shaped, or The inner surface of the proximal end of the inner tube 30 has a proximal fixing ring 32, which can be attached to the proximal outer surface of the core tube 51 to provide support for the core tube 51 and maintain the coaxiality of the core tube 51 and the stability of the system (see the examples below for details). Figures 4C-4D As shown, the inner wall of the distal end of the inner tube 30 is provided with an inner step opening 33, and the inner step opening 33 can form a good matching abutment with the valve constrictor tube 35 (see the examples described later for details).

[0216] like Figures 5A-5B As shown, in this example, the forward push knob 40 is movably provided at the proximal end of the handle housing 10. The purpose of the movable provision is that the forward push knob 40 can rotate freely at the proximal end of the handle housing 10 without falling from the proximal end of the handle housing 10. Specifically, the inner wall of the distal end of the forward push knob 40 has a plurality of annular protrusions 42, and the annular protrusions 42 of the forward push knob 40 are embedded in the annular concave ring 15 of the handle housing 10, thereby positioning the forward push knob 40 at the proximal end of the handle housing 10, and the annular protrusions 42 of the forward push knob 40 can freely rotate in the annular concave ring 15 at the proximal end of the handle housing 10. In another example, the inner wall of the distal end of the forward push knob 40 has a plurality of annular concave rings, and the annular protrusions of the handle housing 10 are embedded in the annular concave ring of the forward push knob 40, thereby positioning the forward push knob 40 at the proximal end of the handle housing 10. Both of these examples involve the distal end of the forward push knob 40 being sheathed outside the proximal end of the handle housing 10. Another example, not shown, is one in which the distal end of the forward push knob 40 is inserted inside the proximal end of the handle housing 10, with several annular convex rings disposed on the distal outer wall of the forward push knob 40 and annular concave rings disposed on the proximal inner wall of the handle housing 10. Another example involves the annular concave rings disposed on the distal outer wall of the forward push knob 40 and the annular convex rings disposed on the proximal inner wall of the handle housing 10. In either case, a freely rotatable connection between the distal end of the forward push knob 40 and the proximal end of the handle housing 10 can be achieved, thereby fulfilling the objectives of the present invention.

[0217] In this example, the knob wall of the forward push knob 40 is snap-connected to the proximal wall of the middle tube 20, and circumferential rotation of the forward push knob 40 drives the middle tube 20 to rotate. The proximal inner wall of the forward push knob 40 has at least one axial groove 41; the axial retaining plate 22 of the proximal outer wall 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 middle figure, the proximal inner wall of the forward push knob 40 has at least one axial retaining plate, and the axial retaining plate of the forward push knob 40 is embedded in the axial groove of the middle tube 20, so that the circumferential rotation of the forward push knob 40 drives the middle tube 20 to rotate. By using any of the two snap-fit ​​connection methods in the above two examples, the forward push knob 40 can stably rotate the middle tube 20, so that the middle tube 20 can stably push the inner tube 30 forward and further push the valve constriction tube 35 connected to the distal end of the inner tube 30 to deliver the artificial valve toward the distal end. Of course, another example is that the axial clamping plate can be set on the proximal inner wall of the middle tube 20, and the axial groove is set on the proximal outer wall of the forward push knob 40, and the axial clamping plate on the proximal inner wall of the middle tube 20 is snap-fitted into the axial groove on the proximal outer wall of the forward push knob 40 to achieve a snap-fit ​​connection. Or another example is that the axial groove is set on the proximal inner wall of the middle tube 20, and the axial clamping plate is set on the proximal outer wall of the forward push knob 40, and the axial clamping plate on the proximal outer wall of the forward push knob 40 is snap-fitted into the axial groove on the proximal inner wall of the middle tube 20 to achieve a snap-fit ​​connection. Regardless of the coupling method, as long as the forward push knob 40 and the middle tube 20 can be coupled in a circumferentially rotatable manner, the forward push knob 40 has a forward push washer 43 sandwiched between the proximal inner wall of the handle housing 10 and the proximal outer wall of the middle tube 30 to reduce friction between the handle housing 10 and the middle tube 20 during rotation.

[0218] like Figure 6 As shown, in this example, the middle section of the core tube 51 is inserted into the inner tube 30, and the proximal end passes through the proximal end of the forward push knob 40; the proximal section of the core tube 51 fits in the proximal fixing ring 32 of the inner tube 30, and the proximal fixing ring 32 provides support for the core tube 51, which can maintain the coaxiality of the core tube 51 and the stability of the system. The distal end of the core tube 51 is located in the middle or distal section of the inner tube 30, and the distal outer wall of the core tube 51 is sleeved with a distal fixing ring 511. A circle of rubber ring 512 is provided on the outer wall of the distal fixing ring 511. The inner wall of the inner tube 30 is pressed tightly against the rubber ring 512 at the distal end of the core tube 51 to seal and isolate the artificial valve in the valve receiving tube 85 from the outside world.

[0219] Continue as Figure 6As shown, in this example, the distal end of the locking head 53 is rotatably connected to the proximal end of the forward push knob 40. The rotatable connection between the distal end of the locking head 53 and the proximal end of the forward push knob 40 can be consistent with the rotatable connection between the forward push knob 40 and the handle housing 10, which will not be described in detail here. This allows the forward push knob 40 to rotate without the locking head 53 rotating accordingly. A locking knob 531 with a sealing ring is provided on the middle section of the locking head 53. The proximal end of the locking head 53 is provided with a nut (not shown in the figure). The proximal end of the core tube 51 is fixed within the distal end of the locking head 53.

[0220] like Figure 1C As shown, in this example, the middle section of the tether 52 is passed through the core tube 51, the distal end of the tether 52 passes through the core tube 51 and is connected to the artificial valve, and the proximal end of the tether 52 passes through the proximal end of the locking head 53 and can be double-locked by the locking knob 531 and / or the nut.

[0221] like Figure 7 As shown, the outer tube 70 of this example is passed through the distal section of the handle shell 10, and the distal section of the handle shell 10 is sleeved on the outside of the outer tube 70. The distal end of the middle tube 20 can extend all the way to the proximal end of the outer tube 70, that is, the outer tube 70 is located between the distal section of the handle shell 10 and the distal end of the middle tube 20. Of course, it is also feasible that the middle tube 20 does not extend to the proximal end of the outer tube 70. However, the inner tube 30 extending from the distal end of the middle tube 20 is passed through the outer tube 70. A tube hole 711 is also passed through the wall of the outer tube 70, and the tube hole 711 corresponds to the position of the shell hole 17 of the handle shell 10. 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, which is connected to the knob internal thread 61 of the retraction knob 60 located in the cavity of the distal section of the handle shell 10, so that when the retraction knob 60 is rotated, the outer tube 70 can be driven to retract linearly toward the proximal end. The proximal end of the outer tube 70 is a cylindrical tube, and the outer wall of the cylindrical tube has a plurality of axially arranged guide plates 72; the guide plates 72 can be stuck on the positioning plates 18 on the inner wall of the distal section of the handle shell 10, so that the outer tube 70 can be retracted non-rotatably and can only be moved linearly toward the proximal end by the retraction knob 60. The distal end of the outer tube 70 is a circular tube 73, and the outer wall of the circular tube 73 has a pair of wall-cut holes 74; the distal end circular tube 73 of the outer tube 70 can be inserted into the proximal end of the transition connector 75, and the cut holes 74 thereon are used to be fixedly connected to the transition connector 75.

[0222] like Figure 8As shown, the retraction knob 60 of this example is disposed within the open cavity of the distal portion of the handle housing 10 and is sleeved onto the outer tube 70. The inner surface of the retraction knob 60 includes an internal knob thread 61, which engages with the outer tube external thread 71. Rotating the retraction knob 60 causes the outer tube 70, along with the valve-receiving tube 85 and sheath sleeve 90 connected thereto, to retract proximally, releasing the prosthetic valve. The retraction knob 60 includes an inner knob ring 63, with the internal knob thread 61 disposed on the inner surface of the inner knob ring 63; an outer knob ring 64 sleeved onto the outer portion of the inner knob ring 63; and a support ring 65 positioned between the inner and outer knob rings 63 and 64 for securely connecting the inner and outer knob rings 63 and 64. This design allows for a larger outer diameter of the outer knob ring 64 and facilitates rotation without increasing material or weight. The retraction knob 60 is provided with a circle of protrusions 62 for positioning on the distal side and the proximal side, respectively. The protrusions 62 of the retraction knob 60 are embedded in the grooves 161 of the square frame 16 of the handle shell 10, so that the retraction knob 60 cannot swing left and right and fits more tightly with the handle shell 10, thereby effectively limiting the retraction knob 60, improving the stability of the retraction knob 60 during the retraction process, as well as the stability of the outer tube 70 passed through the retraction knob 60 and the valve receiving tube 85 and the sheath sleeve 90 connected together with the outer tube 70 during the retraction process. In a further example, the protrusions 62 for positioning are a plurality of protrusions evenly arranged in a circle (as shown in the figure), and the protrusions are evenly embedded in the grooves 161 of the handle shell 10; in another further example, the protrusions 62 for positioning are a circle of protrusions, and the protrusions are embedded in the grooves 161 of the handle shell 10. The retraction knob 60 may also include two retraction washers 66, disposed on the proximal and distal ends of the retraction knob 60. These washers are positioned over the outer tube 70 and engage within the protrusion 62 to reduce friction and enhance stability during rotation. The width of the protrusion 62 is smaller than that of the retraction washers 66, and the retraction knob 60 is rotatably connected to the handle housing 10 via the retraction washers 66.

[0223] Figures 9A to 9D As shown, in this example, the transition piece 75 is a tube with external threads, and the middle section and distal section of the inner tube 30 can pass through the transition piece 75. In order to prevent the inner tube 30 from rotating and only be driven by the middle tube 20 to move forward in a straight line to the distal end, the inner ring of the radial cross section of the transition piece 75 is designed to be a non-circular shape that matches the outer ring of the inner tube 30 and the size is also the same. For example, if the outer ring of the radial cross section of the middle section and distal section of the inner tube 30 is designed to be D-shaped, then the inner ring of the radial cross section of the transition piece 75 is also designed to be D-shaped. In this way, the inner tube 30 can be prevented from being rotated by the middle tube 20 under the restriction of the transition piece 75. Similarly, if the outer ring of the radial cross section of the middle section and distal section of the inner tube 30 is designed to be D-shaped, The inner ring of the radial cross section of the transition piece 75 is also designed to be square, polygonal, with several protrusions, star-shaped, etc. The inner tube 30 of the present invention can be non-rotatable, as long as the cross-sectional shape is non-circular. The proximal end of the transition piece 75 is a flange tube 76, which is inserted outside the circular tube 73 at the distal end of the outer tube 70. The flange tube 76 has a pair of through-holes 77 at corresponding positions. A pair of fixing rods 78 are inserted through the through-holes 77 of the transition piece 75 and the cutouts 74 of the outer tube 70, respectively, thereby fixing the transition piece 75 to the distal end of the outer tube 70. This allows the outer tube 70 to be retracted stably during retraction, preventing the valve-receiving tube 85 from falling off. The inner wall of the flange tube 76 and the outer wall of the circular tube 73 can be further bonded with an adhesive to stably fix the transition piece 75 to the distal end of the outer tube 70 and seal the interior of the transition piece 75. In this example, a pair of cutouts 74 are provided on the outer tube 70, and a transition piece 75 is provided that is detachably connected to the proximal end of the valve-receiving tube 85. Corresponding perforations 77 are provided on the transition piece 75, and a fixing rod 78 is then inserted through the perforations 77 of the transition piece 75 and the cutouts 74 of the outer tube 70. Thus, the transition piece 75 securely connects the outer tube 70 to the valve-receiving tube 85, and the outer tube 70 can be easily disassembled during disassembly. The distal end of the transition piece 75 is a transition piece circular tube that can be inserted into the proximal end of the valve-receiving tube 85 for connection. The outer surface of the transition piece circular tube at the distal end of the transition piece 75 has an axial projection 791 or an axial groove, which allows for connection with the valve-receiving tube 85 to prevent relative rotation between the two. During the process of the transition connector 75 being driven by the outer tube 70 to retract toward the proximal end, the distal axial reinforcement ribs 13 and the distal radial reinforcement ribs 14 are arranged on the distal inner wall of the handle shell 10, so that the outer wall of the transition connector 75 can only fit on the axial reinforcement ribs 13 and the distal radial reinforcement ribs 14, thereby limiting the rotation of the transition connector 75 and allowing it to only retract horizontally toward the proximal end.

[0224] In this example, the valve-receiving tube 85 is a circular tube with a valve-receiving tube 35 pre-installed therein. The distal end of the inner tube 30 extends into the proximal end of the valve-receiving tube 85 and is connected to the proximal end of the valve-receiving tube 35 pre-installed therein. The transition piece circular tube at the distal end of the transition connector 75 is inserted into the flared opening at the proximal end of the valve-receiving tube 85. A cavity sealing gasket 851 is provided at the connection between the distal end of the transition connector 75 and the proximal end of the valve-receiving tube 85. The cavity sealing gasket 851 is sleeved around the outer periphery of the distal section of the inner tube 30, and the transition piece circular tube at the distal end of the transition connector 75 presses the cavity sealing gasket 851 against the flared step at the proximal end of the valve-receiving tube 85. Furthermore, the proximal inner surface of the valve-receiving tube 85 has an axial groove 852. The proximal flared opening of the valve-receiving tube 85 fits over the exterior of the transition piece circular tube at the distal end of the transition connector 75. The axial projection 791 on the exterior of the transition piece circular tube of the transition connector 75 fits into the axial groove 852 of the valve-receiving tube 85, forming a snap-fit ​​connection to prevent relative rotation between the two. In another example (not shown), the exterior surface of the transition piece circular tube at the distal end of the transition connector 75 is provided with an axial groove; the proximal inner surface of the valve-receiving tube 85 is provided with an axial projection. The proximal flared opening of the valve-receiving tube 85 fits over the exterior of the transition piece circular tube at the distal end of the transition connector 75. The axial projection of the valve-receiving tube 85 fits into the axial groove of the transition piece 75, forming a snap-fit ​​connection to prevent relative rotation between the two. In a preferred embodiment, the outer surface of the valve-containing tube 85 has external reinforcing ribs with indicators, such as a "K"-shaped indicator. Since the mitral valve annulus is not circular but rather has a D-shaped structure, the outer stent of the artificial mitral valve is also D-shaped to match the human anatomy. To better install the artificial mitral valve on the mitral valve, the "K"-shaped structure is provided on the outer surface of the valve-containing tube as an indicator of the valve's direction. In this embodiment, the distal outer surface of the valve-containing tube 85 is provided with an axial projection 853, thereby preventing the valve-containing tube 85 and the sheath sleeve 90 from rotating relative to each other. For details, see the following examples.

[0225] In this example, the valve constrictor 35 is a hollow tube pre-placed within the valve-receiving tube 85. The interior of the valve constrictor 35 is a trumpet-shaped structure with its opening facing the distal end, allowing the prosthetic valve to be compressed and placed within. When the prosthetic valve is pre-folded, the proximal end of the prosthetic valve is folded within the trumpet-shaped structure, while the remaining portion is located within the larger space within the valve-receiving tube 85. The proximal outer wall of the valve constrictor 35 is configured with an outer step 351, and the inner step 33 of the inner tube 30 fits over the outer step 351 of the valve constrictor 35 to form an abutment. In another example, the proximal inner wall of the valve constrictor 35 is configured with an inner step, while the distal outer wall of the inner tube 30 is configured with an outer step. The inner step of the valve constrictor 35 fits over the outer step of the inner tube 30 to form an abutment. This approach can also achieve the objectives of the present invention.

[0226] Figures 10A and 10B As shown, in this example, the sheath sleeve 90 serves as a delivery channel for the artificial valve and is connected to the distal end of the valve receiving tube 85. When the middle tube 20 rotates, it can drive the inner tube 30 to push the valve collecting tube 35 along the central axis of the sheath sleeve 90 to deliver the artificial valve toward the distal end. The sheath sleeve 90 has a sheath base 91, an inner sheath 92 and an outer sheath 93. The sheath base 91 is located at the proximal end of the sheath sleeve and has a cavity inside. The distal end of the valve receiving tube 85 is inserted into the cavity of the sheath base 91. The distal end of the cavity has a step opening, and a sheath sealing gasket 94 ( Figure 10B Not shown, see Figure 1C ), the distal end of the valve-holding tube 85 is pressed against the sheath sealing gasket 94, and the distal end of the valve-holding tube 85 is sealed and connected to the sheath base 91 of the sheath sleeve 90 through the sheath sealing gasket 94. In order to prevent relative rotation between the valve-holding tube 85 and the sheath sleeve 90 during delivery and retraction, in this example, an axial groove 911 is provided on the inner surface of the sheath base 91 at the proximal end of the sheath sleeve 90. The proximal end of the sheath sleeve 90 is sleeved on the outer distal end of the valve-holding tube 85, and the axial protrusion 853 of the valve-holding tube 85 is embedded in the axial groove 911 of the sheath sleeve 90 to form a snap connection to prevent relative rotation. In another example (not shown), an axial projection can be provided on the inner surface of the sheath base 91 at the proximal end of the sheath sleeve 90, and an axial groove can be provided on the outer surface of the distal end of the valve-receiving tube 85. The proximal end of the sheath sleeve 90 is inserted into the outer distal end of the valve-receiving tube 85, and the axial projection of the sheath sleeve 90 is inserted into the axial groove of the valve-receiving tube 85 to form a locking connection to prevent relative rotation. Although not shown, this example can also achieve the objectives of the present invention. The proximal end of the inner sheath 92 is connected to the distal end of the sheath base 91. The outer sheath 93 is inserted into the outer surface of the inner sheath 92, and the inner wall of the inner sheath 92 has a smoother and harder surface than that of the outer sheath 93. The proximal end of the outer sheath 93 is connected to the distal end of the sheath base 91. In a preferred embodiment, the outer sheath 93 has a scale on its outer wall, which can be used to determine the retraction endpoint. The outer sheath 93 has a developing ring 95 at its distal end, and the developing ring 95 and the scale together determine the retraction position.

[0227] Figure 11A As shown, in this example, the proximal connector 82 is provided to more securely insert the distal end of the transition connector 75 into the proximal end of the valve accommodating chamber 85. The proximal connector 82 is placed around the periphery where the distal end of the transition connector 75 connects to the proximal end of the valve accommodating chamber 85. The proximal connector 82 is cylindrical in shape and can be formed by symmetrically assembling two semi-cylindrical shells, with the two side walls fixedly connected by bolts. The two ends of the proximal connector 82 are detachably connected to the transition connector 75 and the valve accommodating tube 85, respectively, and the transition connector 72 and the valve accommodating tube 85 are securely connected together through the proximal connector 82.

[0228] The solution provided in this example is that the two ends of the proximal connector 82 are detachably connected to the transition connector 75 and the valve-receiving tube 85, respectively. Specifically, the middle outer surface of the transition connector 75 has a transition outer thread 751; the proximal inner surface of the proximal connector 82 has a proximal inner thread 821. The transition outer thread 751 of the transition connector 75 cooperates with the proximal inner thread 821 of the proximal connector 82, thereby sleeved on the outside of the transition connector 75. The proximal outer surface of the valve-receiving tube 85 has a circle of tube protrusions 854; the distal inner surface of the proximal connector 82 has a circle of hook protrusions 822. The tube protrusions 854 of the valve-receiving tube 85 are hooked on the hook protrusions 822 of the proximal connector 82, thereby sleeved on the proximal outer part of the valve-receiving tube 85. In this way, the transition connector 75 and the valve accommodating tube 85 can be disassembled by simply rotating the proximal connector 82 so that the proximal connector internal thread 821 of the proximal connector 82 is disengaged from the transition external thread 751 of the transition connector 75.

[0229] Another example (not shown) is that the midsection outer surface of the transition connector 75 has a circle of protrusions, and the proximal inner surface of the proximal connector 82 has a circle of hooking protrusions. The protrusions of the transition connector 75 hook onto the proximal hooks of the proximal connector 82, thereby allowing the proximal connector 82 to be sleeved onto the exterior of 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 internal proximal threads. The external threads of the valve-receiving tube 85 are mated and connected to the internal proximal threads of the proximal connector 82, thereby sleeved onto the proximal exterior of the valve-receiving tube 85. This method also allows the transition connector 75 to be disassembled from the valve-receiving tube 85 by simply rotating the proximal connector 82 to disengage the internal proximal threads of the proximal connector 82 from the external threads of the valve-receiving tube 85. Although not shown, this example also achieves the objectives of the present invention. As mentioned above, due to the arrangement of the distal axial reinforcement ribs 13 and the distal radial reinforcement ribs 14 on the distal inner wall of the handle shell 10, when the proximal connecting piece 82 moves forward following the transition connecting piece 75, the outer wall of the proximal connecting piece 82 can only fit on the axial reinforcement ribs 13 and the distal radial reinforcement ribs 14, thereby limiting the rotation of the proximal connecting piece 82 and allowing it to only retreat horizontally toward the proximal end.

[0230] Figure 11BAs shown, in this example, the distal connector 88 is provided to make the distal end of the valve-containing tube 85 more firmly inserted into the proximal end of the sheath sleeve 90. The distal connector 88 is put on the periphery where the distal end of the valve-containing tube 85 is connected to the proximal end of the sheath sleeve 90. The distal connector 88 is similar to the proximal connector 82 and is also cylindrical in shape. It can be composed of two semi-cylindrical shells symmetrically covered and assembled, and the two side walls are fixedly connected by bolts. The two ends of the distal connector 88 are detachably connected to the valve-containing tube 85 and the sheath sleeve 90 respectively, and the valve-containing tube 85 and the sheath sleeve 90 are firmly connected together through the distal connector 88.

[0231] The solution provided in this example is that the two ends of the distal connector 88 are detachably connected to the valve-receiving tube 85 and the sheath sleeve 90, respectively. Specifically, the outer surface of the middle section of the valve-receiving tube 85 has an external tube thread 855; the inner surface of the proximal end of the distal connector 88 has an internal distal thread 881. The external tube thread 855 of the valve-receiving tube 85 and the internal distal thread 881 of the distal connector 88 are mated and connected, thereby allowing the distal connector 88 to be sleeved on the outside of the valve-receiving tube 85. The distal inner surface of the distal connector 88 has a circle of hooks 882; the outer surface of the sheath base 91 at the proximal end of the sheath sleeve 90 has a circle of protrusions 912. The protrusions 912 of the sheath sleeve 90 are hooked onto the hooks 882 of the distal connector 88, thereby allowing the distal connector 88 to be sleeved on the proximal exterior of the sheath sleeve 90. This method also only requires rotating the distal connector 88 so that the distal internal thread 881 of the distal connector 88 is disengaged from the external thread 855 of the valve accommodating tube 85, and the valve accommodating tube 85 and the sheath sleeve 90 can be disassembled.

[0232] Another example (not shown) is that the middle outer surface of the valve-holding tube 85 has a circle of protrusions; the proximal inner surface of the distal connector 88 has a circle of hooks, and the protrusions of the valve-holding tube 85 are hooked onto the proximal hooks of the distal connector 88, thereby allowing the distal connector 88 to be sleeved onto the exterior of the valve-holding tube 85. The proximal outer surface of the sheath base 91 of the sheath sleeve 90 has external threads; the distal inner surface of the distal connector 88 has internal threads, and the external threads of the sheath sleeve 90 are matingly connected to the internal threads of the distal connector 88, thereby allowing the distal connector 88 to be sleeved onto the proximal exterior of the sheath sleeve 90. In this method, the valve-holding tube 85 can be disassembled from the sheath sleeve 90 by simply rotating the distal connector 88 so that the internal threads of the distal connector 88 are disengaged from the external threads of the sheath sleeve 90. Although not shown in the drawings, this example can also achieve the purpose of the present invention.

[0233] The method for using the transapical mitral valve replacement delivery device of the present invention is as follows:

[0234] S1. Use an external preloader to load the artificial mitral valve into the valve receiving tube 85. The proximal end tether 52 (not shown) is gathered into the trumpet-shaped valve gathering tube 35. The tether 52 is pulled out from the other end of the valve gathering tube 35.

[0235] S2. Connect the transition connector 75 to the valve containing tube 85 through the proximal connector 82, and connect the valve containing tube 85 to the sheath sleeve 90 through the distal connector 88. The tether 52 passes through the core tube 51 and extends into the proximal locking head 53 and is pulled out for use.

[0236] S3. Rotate the forward push knob 40. The axial groove 41 of the forward push knob 40 engages the axial retaining plate 22 at the proximal end of the middle tube 20, causing the middle tube 20 to rotate. The internal threads 21 of the middle tube 20 threadably engage the external threads 31 of the inner tube 30, driving the inner tube 30 axially distally. Because the distal end of the inner tube 30 abuts the valve constrictor 35, the constrictor 35 and the prosthetic mitral valve within it move distally in a straight line until they reach the distal end of the sheath 90.

[0237] S4. Prepare for releasing the artificial valve: Rotate the locking knob on the locking head 53 to lock the tether 52 to prevent the artificial valve from rushing out of the conveyor and colliding with the inner wall of the heart due to excessive impact during the release of the artificial valve.

[0238] S5. Rotate the retraction knob 60, which drives the outer tube 70 to move axially (proximally) without rotation. The outer tube 70 in turn drives the valve receiving tube 85 and the sheath sleeve 90 to move proximally together, gradually releasing the artificial valve.

[0239] The specific embodiments described herein are merely illustrative of the spirit of the present invention. Persons skilled in the art may make various modifications, additions, or substitutions to the described specific embodiments without departing from the spirit of the present invention or exceeding the scope of the appended claims.

Claims

1. A transapical mitral valve replacement delivery device, comprising: An outer tube, the outer surface of which has an outer tube external thread; a handle shell, wherein a distal end of the handle shell is sleeved outside the outer tube; a retraction knob disposed in the open cavity of the distal end of the handle housing, wherein the inner surface of the retraction knob has an internal knob thread, and the internal knob thread is connected to the external thread of the outer tube; a transition connector, the proximal end of which is fixedly connected to the distal 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 connected to the distal end of the valve-containing tube; It is characterized in that The distal end of the outer tube is a circular tube, and the outer wall of the circular tube has a pair of cut-wall holes; The proximal end of the transition piece is a flange pipe, which is passed through the outside of the circular tube. The flange pipe has a pair of through-holes at corresponding positions. A pair of fixing rods are respectively passed through the through-holes of the transition piece and the cut-out holes of the outer tube, thereby fixing the transition piece to the distal end of the outer tube. a valve constrictor tube, which can be pre-placed in the valve accommodating tube; a middle tube, the middle tube being inserted into the handle shell, and the inner surface of the middle tube having an inner tube thread; An inner tube, the proximal section of which is passed through the interior of the middle tube, and the distal section of which is non-rotatably passed through the transition connector and passed through the proximal end of the valve-containing tube. A cavity sealing gasket is provided at the connection between the distal end of the transition connector 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. The distal end of the inner tube is connected to the valve convergence tube. The proximal end outer surface of the inner tube has an inner tube external thread, and the inner tube external thread is cooperatively connected to the inner thread of the middle tube. A forward push knob is provided at the proximal end of the handle shell, wherein the button wall of the forward push knob is snap-connected to the proximal wall of the middle tube; Wherein, the outer ring of the radial cross section of the middle section and the distal section of the inner tube is non-circular; The inner circle of the radial cross section of the transition connector is non-circular and matches the shape and size of the outer circle of the radial cross section of the middle and distal sections of the inner tube. The middle and distal sections of the inner tube are inserted into the transition connector and cannot rotate.

2. The transapical mitral valve replacement delivery device according to claim 1, wherein: The inner wall of the flange pipe and the outer wall of the circular pipe are bonded with adhesive to further fix the transition connector to the distal end of the outer pipe.

3. The transapical mitral valve replacement delivery device according to claim 1 or 2, characterized in that: The distal outer surface of the transition connector has an axial protrusion; The inner surface of the proximal end of the valve accommodating tube has an axial groove, the proximal end of the valve accommodating tube is sleeved on the outside of the distal end of the transition connector, and the axial protrusion of the transition connector is embedded in the axial groove of the valve accommodating tube to form a snap connection.

4. The transapical mitral valve replacement delivery device according to claim 1 or 2, characterized in that: The distal outer surface of the transition piece has an axial groove; The inner surface of the proximal end of the valve accommodating tube has an axial protrusion, the proximal end of the valve accommodating tube is sleeved on the outside of the distal end of the transition connector, and the axial protrusion of the valve accommodating tube is embedded in the axial groove of the transition connector to form a snap connection.

5. The transapical mitral valve replacement delivery device according to claim 1 or 2, characterized in that: The distal outer surface of the valve accommodating tube is provided with an axial protrusion; The inner surface of the proximal end of the sheath sleeve has an axial groove, the proximal end of the sheath sleeve is sleeved on the outside of the distal end of the valve accommodating tube, and the axial protrusion of the valve accommodating tube is embedded in the axial groove of the sheath sleeve to form a clamping connection.

6. The transapical mitral valve replacement delivery device according to claim 1 or 2, characterized in that: The distal outer surface of the valve accommodating tube has an axial groove; The inner surface of the proximal end of the sheath sleeve has an axial protrusion, the proximal end of the sheath sleeve is sleeved on the outside of the distal end of the valve accommodating tube, and the axial protrusion of the sheath sleeve is embedded in the axial groove of the valve accommodating tube to form a clamping connection.

7. The transapical mitral valve replacement delivery device according to claim 1 or 2, characterized in that: The transapical mitral valve replacement delivery device further comprises: A proximal connector has two ends detachably connected to the transition connector and the valve accommodating tube, and the transition connector and the valve accommodating tube are connected together through the proximal connector.

8. The transapical mitral valve replacement delivery device according to claim 7, wherein: The outer surface of the middle section of the transition connector has a transition external thread; The proximal inner surface of the proximal connecting piece has a proximal internal thread, and the transition external thread of the transition connecting piece is matched with the proximal internal thread of the proximal connecting piece, so that the proximal connecting piece is sleeved on the outside of the transition connecting piece; The proximal outer surface of the valve accommodating tube is provided with a circle of tube protrusions; The distal inner surface of the proximal connector has a circle of hooks, and the tube protrusion of the valve accommodating tube is hooked on the hooks of the proximal connector, so that the proximal connector is sleeved on the proximal exterior of the valve accommodating tube.

9. The transapical mitral valve replacement delivery device according to claim 7, wherein: The outer surface of the middle section of the transition connector is provided with a circle of pipe protrusions; The inner surface of the proximal end of the proximal connector has a circle of hook protrusions, and the pipe protrusion of the transition connector is hooked on the hook protrusion of the proximal end of the proximal connector, so that the proximal connector is sleeved on the outside of the transition connector; The proximal outer surface of the valve accommodating tube has an external tube thread; The distal inner surface of the proximal connector has a proximal inner thread, and the outer thread of the valve accommodating tube is fitted and connected to the proximal inner thread of the proximal connector, thereby sleeved on the proximal exterior of the valve accommodating tube.

10. The transapical mitral valve replacement delivery device according to claim 1 or 2, characterized in that: The transapical mitral valve replacement delivery device further comprises: A distal connector has two ends detachably connected to the valve accommodating tube and the sheath sleeve, and the valve accommodating tube and the sheath sleeve are connected together through the distal connector.

11. The transapical mitral valve replacement delivery device according to claim 10, wherein: The outer surface of the middle section of the valve accommodating tube has an external tube thread; The proximal inner surface of the distal connector has a distal internal thread, and the distal connector is connected to the valve accommodating tube through the external thread of the valve accommodating tube and the distal internal thread of the distal connector, so that the distal connector is sleeved on the outside of the valve accommodating tube; The distal inner surface of the distal connecting piece has a circle of hooks and protrusions; The outer surface of the proximal end of the sheath sleeve is provided with a circle of tube protrusions, and the tube protrusions of the sheath sleeve are hooked on the hook protrusions of the distal connector, so that the distal connector is sleeved on the proximal end of the sheath sleeve.

12. The transapical mitral valve replacement delivery device according to claim 10, wherein: The outer surface of the middle section of the valve accommodating tube is provided with a circle of tube protrusions; The inner surface of the proximal end of the distal connector has a circle of hook convexities, and the tube convexities of the valve accommodating tube are hooked on the hook convexities at the proximal end of the distal connector, so that the distal connector is sleeved on the outside of the valve accommodating tube; The outer surface of the proximal end of the sheath tube sleeve has an external tube thread; The distal inner surface of the distal connector has a distal inner thread, and the outer thread of the sheath sleeve is fitted and connected to the distal inner thread of the distal connector, thereby sleeved on the proximal exterior of the sheath sleeve.

13. The transapical mitral valve replacement delivery device according to claim 1, wherein: The sheath tube sleeve has: a sheath base located at the proximal end of the sheath sleeve, wherein the sheath base of the sheath sleeve is connected to the distal end of the valve accommodating tube; an inner sheath tube, wherein the proximal end of the inner sheath tube is connected to the distal end of the sheath tube base; An outer sheath is sleeved outside the inner sheath, and the proximal end of the outer sheath is connected to the distal end of the sheath base.

14. The transapical mitral valve replacement delivery device according to claim 7, wherein: The distal inner wall of the handle shell has: A plurality of distal axial reinforcing ribs, axially fixed to the distal inner wall of the handle shell; A plurality of distal radial reinforcing ribs, radially fixed to the distal inner wall of the handle shell; The distal axial reinforcement ribs and the distal radial reinforcement ribs may be fitted onto outer walls of the transition connector and the proximal connector.

15. The transapical mitral valve replacement delivery device according to claim 1, wherein: The transapical mitral valve replacement delivery device further comprises: a central core tube, which is inserted into the inner tube, and the proximal end of the central core tube passes through the proximal end of the forward push knob; The inner surface of the proximal end of the inner tube is provided with a proximal fixing ring, and the proximal end of the core tube is fitted into the proximal fixing ring of the inner tube; The distal outer wall of the core tube is sleeved with a distal fixing ring, the outer wall of the distal fixing ring is circumferentially provided with a rubber ring, and the inner wall of the inner tube is pressed tightly against the rubber ring at the distal end of the core tube.

16. The transapical mitral valve replacement delivery device according to claim 15, wherein: The transapical mitral valve replacement delivery device further comprises: a locking head, wherein the distal end of the locking head is movably connected to the proximal end of the forward push knob, a locking knob with a sealing ring is provided on the middle section of the locking head, a nut is provided at the proximal end of the locking head, and the proximal end of the core tube is fixed within the distal end of the locking head; A tether is passed through the core tube, and the proximal end of the tether passes through the proximal end of the locking head and can be locked by the locking knob and / or the nut.

17. The transapical mitral valve replacement delivery device according to claim 13, wherein: The outer wall of the outer sheath tube is provided with scales, and the distal end of the outer sheath tube is provided with a developing ring; the inner wall of the inner sheath tube is smoother and harder than that of the outer sheath tube.

18. The transapical mitral valve replacement delivery device according to claim 13, wherein: A sheath sealing gasket is provided in the sheath base of the sheath sleeve, and the distal end of the valve accommodating tube is sealed and connected to the proximal end of the sheath sleeve via the sheath sealing gasket.

19. The transapical mitral valve replacement delivery device according to claim 1, wherein: The distal inner wall of the forward push knob is provided with a plurality of circumferential protrusions; The proximal outer wall of the handle shell has 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 screwed to the proximal end of the handle shell.

20. The transapical mitral valve replacement delivery device according to claim 1, wherein: The distal inner wall of the forward push knob is provided with a plurality of circumferential concave rings; The proximal outer wall of the handle shell has a plurality of corresponding annular convex rings, which are embedded in the annular concave ring of the front push knob through the annular convex ring of the handle shell, so that the front push knob is screwed to the proximal end of the handle shell.

21. The transapical mitral valve replacement delivery device according to claim 19 or 20, wherein: The forward push knob has a forward push washer, which is sandwiched between the proximal inner wall of the handle shell and the proximal outer wall of the middle tube to reduce friction between the handle shell and the middle tube during rotation.

22. The transapical mitral valve replacement delivery device according to claim 14, wherein: The proximal inner wall of the forward push knob has at least one axial groove; The proximal outer wall of the middle tube has at least one axial clamping plate; the axial clamping plate of the middle tube is embedded in the axial groove of the forward push knob, so that the circumferential rotation of the forward push knob drives the middle tube to rotate.

23. The transapical mitral valve replacement delivery device according to claim 1, wherein: The proximal inner wall of the forward push knob has at least one axial clamping plate; The proximal wall of the middle tube has at least one axial groove; the axial clamping plate of the forward push knob is embedded in the axial groove of the middle tube, so that the circumferential rotation of the forward push knob drives the middle tube to rotate.

24. The transapical mitral valve replacement delivery device according to claim 1, wherein: The outer rings of the radial cross sections of the middle and distal sections of the inner tube are D-shaped or polygonal; The inner circle of the radial cross section of the transition connector is D-shaped or polygonal.

25. The transapical mitral valve replacement delivery device according to claim 24, wherein: The polygon is a square.

26. The transapical mitral valve replacement delivery device according to claim 1, wherein: The inner wall of the near section of the handle shell has: A plurality of proximal axial reinforcing ribs, axially fixed to the proximal inner wall of the handle shell; A plurality of proximal radial reinforcing ribs, radially fixed to the proximal inner wall of the handle shell; The proximal axial reinforcement ribs and the proximal radial reinforcement ribs can be fitted on the outer wall of the middle tube.

27. The transapical mitral valve replacement delivery device according to claim 1, wherein: The opening of the handle shell is a square frame that passes through the handle shell, and the square frame is provided with a circle of grooves for locking on the distal frame wall and / or the proximal frame wall; The retraction knob is provided with a circle of protrusions for locking on the distal side surface and / or the proximal side surface, and the protrusions of the retraction knob are embedded in the grooves of the handle shell.

28. The transapical mitral valve replacement delivery device of claim 27, wherein The circle of protrusions for locking is a plurality of protrusion columns evenly arranged in a circle, and the protrusion columns are evenly embedded in the grooves of the handle shell.

29. The transapical mitral valve replacement delivery device of claim 27, wherein The circle of protrusions for locking is a circle of protruding rings, and the protruding rings are embedded in the grooves of the handle shell.

30. The transapical mitral valve replacement delivery device of claim 27, wherein The retracement knob has: Two retraction washers are arranged on the proximal end surface and the distal end surface of the retraction knob, sleeved outside the outer tube and clamped in the protrusion.

31. The transapical mitral valve replacement delivery device of claim 30, wherein The width of the protrusion is smaller than the width of the retraction washer, and the retraction knob is rotatably connected to the handle shell through the retraction washer.

32. The transapical mitral valve replacement delivery device of claim 27, wherein The retracement knob has: An inner button ring, wherein the inner thread of the knob is provided on the inner surface of the inner button ring; An outer button ring, sleeved outside the inner button ring; A support ring is located between the inner button ring and the outer button ring and is used to fix the inner button ring and the outer button ring.

33. The transapical mitral valve replacement delivery device of claim 32, wherein: The outer wall of the proximal end of the outer tube is provided with a plurality of axially arranged guide plates; The inner wall of the handle shell is provided with a plurality of axially arranged positioning plates, and the guide plate can be clamped on the directional plate.

Images