Transapical mitral valve replacement delivery device

Abstract

The application discloses a delivery device for heart apex mitral valve replacement, which comprises a handle shell, a withdrawal tube, a pushing tube, a delivery tube, a middle core tube and a tether from outside to inside in sequence in a proximal section, and a knob and a locking head are arranged in the proximal section; the delivery device further comprises a handle shell, an outer tube, a withdrawal tube distal section, a delivery tube distal section, a middle core tube distal section and a tether distal section from outside to inside in sequence in a distal section; the distal section comprises the outer tube, a valve containing tube and a sheath tube cover which are sequentially connected from a proximal end to a distal end, a connecting piece which is used for detachably connecting the valve containing tube and the sheath tube cover together, and a valve gathering tube which is arranged in the valve containing tube and connected with a distal end of the delivery tube.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a transapical mitral valve replacement delivery device. Background Technology

[0002] In China, nearly 10 million people suffer from valvular heart disease each year, especially mitral valve disease. Because the mitral valve annulus is not a standard circle but rather D-shaped, double-layer stents are currently the most researched method to simultaneously fit the mitral valve annulus and maintain the seal of the artificial valve leaflet. To avoid the limitations on the compression diameter of the transfemoral approach and the invasiveness of traditional open-heart methods, mitral valve replacement is now more commonly performed via the transapical approach.

[0003] Patent application CN107750150A discloses a device and method for delivering, repositioning, and retrieving a transcatheter prosthetic valve. However, this device includes a housing, a delivery rod, a guide screw, a holding mechanism, a valve holding tube, and a catheter assembly, and also features proximal and distal actuator knobs. The two knobs are used for valve delivery and valve retraction, respectively. Furthermore, the valve loader must first pre-load the valve into the valve holding tube, then remove the valve holding tube from the loader and connect it to the delivery device. This operation is complex and increases the workload of medical personnel. Summary of the Invention

[0004] This invention addresses the technical problem of existing transapical mitral valve replacement delivery devices having two knobs, which leads to a complex product structure. The aim is to provide a new technical solution for a transapical mitral valve replacement delivery device.

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

[0006] One handle casing;

[0007] A knob, the distal end of which is movably connected to the proximal end of the handle housing;

[0008] A push tube is disposed in the proximal section of the handle housing, the proximal end of the push tube passes through the proximal end of the knob, the knob can selectively rotate the push tube, and the inner surface of the push tube has a push internal thread;

[0009] A delivery tube is inserted into the push tube at its proximal end. The outer surface of the proximal end of the delivery tube has a delivery external thread, which is connected to the push internal thread. The delivery tube is pushed to move linearly to the distal end by the rotation of the push tube.

[0010] A retraction tube is disposed within the proximal section of the handle housing and sleeved outside the push tube. The proximal end of the retraction tube passes through the distal end of the knob. The knob can selectively rotate the retraction tube. The distal end of the retraction tube has a retraction external thread on its outer surface.

[0011] An outer tube is non-rotatably disposed within the distal section of the handle housing and its proximal section is fitted outside the distal section of the retraction tube. The inner surface of the outer tube has a retraction internal thread, and the retraction external thread engages with the retraction internal thread. The rotation of the retraction tube pulls the outer tube to move linearly toward the proximal end. The distal section of the delivery tube is non-rotatably inserted within the distal section of the outer tube.

[0012] Preferably, the transapical mitral valve replacement delivery device of the present invention further comprises:

[0013] A valve constriction tube, which can constrict an artificial valve internally, with its proximal end abutting against the distal end of the delivery tube;

[0014] A valve receiving tube, with the valve constricting tube pre-installed inside, the proximal end of the valve receiving tube connected to the distal end of the outer tube;

[0015] A sheath sleeve is detachably connected to the distal end of the valve receiving tube. The delivery tube is pushed by the rotation of the push tube, which in turn drives the valve constricting tube to move linearly toward the distal end within the sheath sleeve.

[0016] Preferably, the transapical mitral valve replacement delivery device of the present invention further comprises:

[0017] A core tube is inserted inside the conveying pipe;

[0018] A rope is threaded through the core tube;

[0019] A locking head is movably connected to the proximal end of the knob, the proximal end of the central tube extends and is fixed inside the locking head, and the tether extends from the proximal end of the central tube and passes through the proximal end of the locking head.

[0020] Preferably,

[0021] The inner surface of the proximal end of the delivery tube has a proximal support ring, through which the core tube passes and fits within the proximal support ring, and is supported by the proximal support ring.

[0022] A distal fixing ring is fixed on the distal outer surface of the core tube, and the outer surface of the distal fixing ring has a sealing ring. The delivery tube is tightly fitted on the distal fixing ring.

[0023] Preferably,

[0024] The outer tube has a distal section tube, and the outer wall of the distal section tube has a pair of cut holes;

[0025] The proximal section of the valve receiving tube has a flange tube, and a pair of through holes are located at corresponding positions on the side wall of the flange tube. A stepped hole is located inside the flange tube.

[0026] The distal section of the outer tube abuts against the stepped hole of the flange tube in the proximal section of the valve receiving tube, and is fixed by a pair of fixing pins passing through the perforation and cut hole, thereby fixing the distal section of the outer tube through the stepped hole in the proximal section of the valve receiving tube.

[0027] Preferably,

[0028] A cavity sealing gasket is provided at the bottom of the stepped hole, and the distal section of the outer tube is sealed and fixed by the cavity sealing gasket and inserted into the stepped hole of the proximal section of the valve receiving tube.

[0029] Preferably,

[0030] The distal outer surface of the valve receiving tube has an axial protrusion;

[0031] The inner surface of the proximal end of the sheath sleeve has an axial groove. The proximal end of the sheath sleeve is fitted over the distal end of the valve receiving tube. The axial protrusion of the valve receiving tube is embedded in the axial groove of the sheath sleeve to form a snap-fit ​​to prevent relative rotation.

[0032] Preferably,

[0033] The distal outer surface of the valve receiving tube has an axial groove;

[0034] The inner surface of the proximal end of the sheath sleeve has an axial protrusion. The proximal end of the sheath sleeve is fitted over the outer end of the distal end of the valve receiving tube. The axial protrusion of the sheath sleeve is embedded in the axial groove of the valve receiving tube to form a snap-fit ​​to prevent relative rotation.

[0035] Preferably, the transapical mitral valve replacement delivery device of the present invention further comprises:

[0036] A connector is provided, with its two ends detachably connected to the valve receiving tube and the sheath sleeve, respectively, thereby connecting the valve receiving tube and the sheath sleeve together.

[0037] Preferably,

[0038] The outer surface of the middle section of the valve receiving tube has external threads;

[0039] The inner surface of the proximal end of the connector has an internal thread, which is connected to the valve receiving tube by the external thread of the valve receiving tube and the internal thread of the connector, thereby fitting the connector onto the outside of the valve receiving tube.

[0040] The distal inner surface of the connector has a ring of hooks and protrusions;

[0041] The outer surface of the proximal end of the sheath sleeve has a tube protrusion. The tube protrusion of the sheath sleeve is hooked onto the hook protrusion of the connector, thereby fitting the connector onto the outside of the proximal end of the sheath sleeve.

[0042] Preferably,

[0043] The outer surface of the middle section of the valve receiving tube has a ring of tube protrusions;

[0044] The proximal inner surface of the connector has a ring of hooks and protrusions. The protrusion of the valve receiving tube hooks onto the hooks and protrusions of the connector, thereby fitting the distal connector onto the outside of the valve receiving tube.

[0045] The outer surface of the proximal end of the sheath sleeve has external threads;

[0046] The distal inner surface of the connector has an internal thread, and the external thread of the sheath sleeve is engaged with the internal thread of the connector, thereby fitting the connector onto the proximal outside of the sheath sleeve.

[0047] Preferably, the sheath sleeve has:

[0048] A sheath base is located at the proximal end of the sheath sleeve, and the sheath base of the sheath sleeve is connected to the distal end of the valve receiving tube.

[0049] An inner sheath, the proximal end of which is connected to the distal end of the sheath base;

[0050] An outer sheath is fitted over the inner sheath, and the proximal end of the outer sheath is connected to the distal end of the sheath base.

[0051] Preferably,

[0052] The sheath base of the sheath sleeve has a sheath sealing gasket, through which the distal end of the valve receiving tube is sealed to the proximal end of the sheath sleeve.

[0053] Preferably,

[0054] The outer wall near the proximal end of the outer tube has several axially arranged guide plates;

[0055] The inner wall of the handle housing has several axially arranged positioning plates, and the guide plate can be locked on the positioning plates, so that the outer tube is non-rotatably located in the distal section of the handle housing.

[0056] Preferably,

[0057] The outer ring of the radial section of the distal section of the conveying pipe is non-circular;

[0058] The inner circle of the radial section of the distal section of the outer tube is a non-circular shape and size that matches the outer circle of the radial section of the distal section of the conveying tube, so that the distal section of the conveying tube is non-rotatably inserted into the distal section of the outer tube.

[0059] Preferably,

[0060] The outer ring of the radial cross-section of the distal section of the conveying pipe is D-shaped or square-shaped. Shaped, square, or polygonal;

[0061] The inner ring of the radial section of the distal section of the outer tube is D-shaped or U-shaped. Shaped, square, or polygonal.

[0062] Preferably, the distal inner wall of the handle housing has:

[0063] Several distal axial reinforcing ribs are axially fixed to the distal inner wall of the handle housing;

[0064] Several distal radial reinforcing ribs are radially fixed to the distal inner wall of the handle housing;

[0065] The distal axial reinforcing rib and the distal radial reinforcing rib can be attached to the outer wall of the outer tube and the valve receiving tube.

[0066] Preferably, the proximal inner wall of the handle housing has:

[0067] Several proximal axial reinforcing ribs are axially fixed to the proximal inner wall of the handle housing;

[0068] Several radial reinforcing ribs are radially fixed to the inner wall of the proximal section of the handle housing;

[0069] The proximal axial reinforcing rib and the proximal radial reinforcing rib can be attached to the outer wall of the retraction tube.

[0070] Preferably,

[0071] The locking head has a locking knob with a sealing ring on the middle section, and a nut is provided at the near end of the locking head;

[0072] The proximal end of the tether extends from the proximal end of the locking head and can be locked by the locking knob and / or the nut.

[0073] Preferably, the outer sheath has graduations on its outer wall and a radiopaque ring at its distal end; the inner sheath has a smoother and harder inner wall than the outer sheath.

[0074] Preferably,

[0075] The inner wall of the distal end of the knob has several shell grooves;

[0076] The outer wall of the near end of the handle housing has several corresponding shell protrusions. The shell protrusions of the handle housing are embedded in the shell groove of the knob, thereby screwing the knob into the near end of the handle housing.

[0077] Preferably,

[0078] The inner wall of the distal end of the knob has several shell-shaped protrusions;

[0079] The outer wall of the near end of the handle housing has several corresponding housing slots. The housing protrusion of the knob is embedded in the housing slot of the handle housing, thereby rotating the knob to the near end of the handle housing.

[0080] Preferably,

[0081] The inner wall of the near end of the knob has several locking grooves;

[0082] The distal outer wall of the locking head has several corresponding locking protrusions. The locking protrusions of the locking head are embedded in the locking groove of the knob, thereby screwing the proximal end of the knob onto the distal end of the locking head.

[0083] Preferably,

[0084] The inner wall of the near end of the knob has several locking protrusions;

[0085] The distal outer wall of the locking head has several corresponding locking grooves. The locking protrusion of the knob is embedded in the locking groove of the locking head, thereby rotating the proximal end of the knob to the distal end of the locking head.

[0086] Preferably,

[0087] The proximal ends of the push tube and the retraction tube are respectively fixed with retaining rings, and the outer diameter of the retaining ring at the proximal end of the retraction tube is consistent with the outer diameter of the retaining ring at the proximal end of the push tube;

[0088] The proximal retaining ring of the push tube can be engaged with the proximal end inside the knob, and the proximal retaining ring of the retraction tube can be engaged with the distal end inside the knob. By means of the proximal retaining rings of the push tube and the retraction tube, the knob can selectively rotate the push tube or the retraction tube.

[0089] Preferably,

[0090] The proximal retaining ring of the push tube and the proximal retaining ring of the retraction tube each have M evenly distributed retaining holes on their circumferential surfaces, where M is a natural number ≥ 1.

[0091] The present invention also provides a circular tube for a transapical mitral valve replacement delivery device, wherein a retaining ring is fixedly provided at the proximal end of the circular tube, and the retaining ring has M evenly distributed retaining holes on its circumferential surface, where M is a natural number ≥ 1.

[0092] Preferably, the retaining ring has:

[0093] The proximal end of the retaining ring is a proximal end ring;

[0094] The distal end of the retaining ring is a distal ring;

[0095] The middle part of the retaining ring consists of M connecting rods. The proximal and distal ends of the connecting rods are fixedly connected to the proximal ring and the distal ring at even intervals, respectively. Two adjacent connecting rods together with the proximal ring and the distal ring form the retaining opening.

[0096] Preferably,

[0097] The outer surface of the proximal ring slopes from the proximal end to the distal end toward the center point of the retaining ring;

[0098] The outer surface of the distal ring slopes from the distal end to the proximal end toward the center point of the retaining ring;

[0099] The outer surface of the connecting rod slopes from the center line of the surface axis to both sides towards the center point of the retaining ring, thereby forming a truncated quadrangular cavity that narrows towards the center point of the retaining ring.

[0100] Preferably, the circular tube is a push tube, and the inner surface of the push tube has a push internal thread.

[0101] Preferably, the circular tube is a retraction tube, and the distal end of the outer surface of the retraction tube has a retraction external thread.

[0102] The present invention further provides a circular tube sleeve for a transapical mitral valve replacement delivery device, the circular tube sleeve having:

[0103] The push tube of the present invention is located inside the circular tube sleeve;

[0104] The retraction tube of the present invention is located outside the circular tube sleeve;

[0105] The retraction tube is sleeved outside the push tube, and the outer diameter of the proximal retaining ring of the retraction tube is consistent with the outer diameter of the proximal retaining ring of the push tube.

[0106] Preferably, the circular sleeve further comprises:

[0107] A knob with an internal tube channel; a proximal retaining ring for the push tube is located inside the knob, and a proximal retaining ring for the retraction tube is located inside the knob; the knob can selectively rotate the push tube or the retraction tube.

[0108] The present invention also provides a knob, the knob having:

[0109] A knob housing with N waist-shaped grooves on the upper part;

[0110] N rocker arms are pivotally mounted inside the knob housing and located at corresponding positions in the outer wall groove. The proximal and distal ends of the rocker arms can be selectively locked in the slot of the proximal end retaining ring of the push tube or the slot of the proximal end retaining ring of the retraction tube.

[0111] N sliders are respectively locked in the grooves on the outer wall of the knob housing. The inner ends of the sliders are switched back and forth between the proximal and distal ends of the rocker arm, so that the rocker arm rises and falls back and forth between the proximal and distal ends, thereby allowing the proximal and distal ends of the rocker arm to be selectively locked in the locking slot of the proximal end retaining ring of the push tube or the locking slot of the proximal end retaining ring of the retraction tube.

[0112] Where N is a natural number ≥ 1, and M ≥ N.

[0113] Preferably,

[0114] The retaining ring has:

[0115] The proximal end of the retaining ring is a proximal end ring;

[0116] The distal end of the retaining ring is a distal ring;

[0117] The middle part of the retaining ring consists of M connecting rods. The proximal and distal ends of the connecting rods are fixedly connected to the proximal ring and the distal ring at even intervals, respectively. Two adjacent connecting rods together with the proximal ring and the distal ring form the retaining opening.

[0118] Preferably,

[0119] The outer surface of the proximal ring slopes from the proximal end to the distal end toward the center point of the retaining ring;

[0120] The outer surface of the distal ring slopes from the distal end to the proximal end toward the center point of the retaining ring;

[0121] The outer surface of the connecting rod slopes from the center line of the surface axis to both sides towards the center point of the retaining ring, thereby forming a truncated quadrangular cavity that narrows towards the center point of the retaining ring.

[0122] Preferably, the seesaw has:

[0123] A rocker arm, which is short and U-shaped, is arranged parallel to the axial direction of the knob housing. The proximal end and distal end of the rocker arm can be selectively locked in the slot of the proximal end retaining ring of the push tube or the slot of the proximal end retaining ring of the retraction tube.

[0124] Two rocker arms extend vertically from the middle of the two sides of the rocker arm, and the rocker arms pass through the inner wall of the knob housing.

[0125] Preferably, the rocker arm has:

[0126] A bottom arm with an outward concave shape, and the rocker shaft extends from the midpoint of the two sides of the bottom arm;

[0127] The proximal arms extend from the proximal end of the bottom arm at a certain angle;

[0128] The distal arms extend from the distal end of the bottom arm at a certain angle;

[0129] The proximal arm and the distal arm can be selectively locked in the slot of the proximal retaining ring of the push tube or the slot of the proximal retaining ring of the retraction tube.

[0130] Preferably, the tilting arm is divided into:

[0131] The midpoint is located at the center of the bottom-hanging arm;

[0132] A near-bottom arm extends integrally from the midpoint toward the proximal end, and a near-side arm extends integrally from the proximal end of the near-bottom arm at a certain angle;

[0133] A distal bottom arm extends integrally from the midpoint toward the distal end, and a distal side arm extends integrally from the distal end of the distal bottom arm at a certain angle.

[0134] With the midpoint as the corner vertex, the angle α between the near bottom arm and the far bottom arm is 130-180°, preferably 150-160°.

[0135] Preferably,

[0136] The proximal arm extends integrally from the proximal end of the proximal arm at an angle β.

[0137] The distal arm extends integrally from the distal end of the distal bottom arm at a certain angle β, where β is 70-100°, preferably 75-90°.

[0138] Preferably,

[0139] The four arm faces of the proximal and distal arms have progressively inclined first-level arm faces, second-level arm faces, third-level arm faces, and so on up to the end face, making it easier to engage with the slot of the proximal retaining ring of the push tube or the slot of the proximal retaining ring of the retraction tube.

[0140] Preferably,

[0141] The outer end of the slider is a push block, located outside the outer wall groove of the knob housing. The width of the push block is greater than the width of the narrowest part of the outer wall groove of the knob housing.

[0142] The middle part of the slider is a waist column, one end of which is fixedly connected to the inner side wall of the push block. The outer diameter of the waist column is smaller than the width of the narrowest part of the outer wall groove of the knob shell, and it is movably locked at the narrowest part of the outer wall groove of the knob shell.

[0143] The inner end of the slider is a stop block, one end of which is fixedly connected to the other end of the waist column. The outer diameter of the stop block is larger than the narrowest width of the groove on the outer wall of the knob shell. The other end of the stop block abuts against the rocker arm and can slide back and forth between the proximal and distal ends of the rocker arm.

[0144] Preferably, the abutment has:

[0145] A cylindrical segment, one end of which is fixedly connected to the other end of the waist column;

[0146] A hemispherical segment extends integrally from the other end of the cylindrical segment, and the spherical surface of the hemispherical segment abuts against the seesaw.

[0147] Preferably, the push block is waist-shaped, and the outer side wall of the push block has several protrusions to increase friction.

[0148] Preferably, the knob housing is generally cylindrical, hollow inside, and has the following characteristics:

[0149] The N outer wall grooves are waist-shaped, and the slider is slidably engaged in the outer wall grooves;

[0150] N inner wall grooves are provided at positions corresponding to the outer wall grooves and are connected to the outer wall grooves. The seesaw rod is provided in the inner wall grooves.

[0151] Preferably,

[0152] The inner side of the outer wall groove is a small waist-shaped groove, located in the middle of the shell wall of the knob housing, and the waist column of the slider is slidably engaged in the small waist-shaped groove.

[0153] The outer side of the outer wall groove is a large waist-shaped groove, which corresponds to and is connected to the small waist-shaped groove. The large waist-shaped groove accommodates the push block of the slider.

[0154] Preferably, pivot holes are provided on both sides of the inner wall groove, and the two ends of the rocker arm are respectively inserted into the pivot holes on both sides of the inner wall groove.

[0155] Preferably, N is 2.

[0156] Preferably, a washer is provided in the inner cavity of the knob housing at the middle position of the rocker arm. The washer is sleeved on the outside of the push tube and the retraction tube, and is located between the proximal retaining ring of the push tube and the proximal retaining ring of the retraction tube.

[0157] Preferably, the proximal end of the push tube is fixedly provided with an expanding ring with the same thickness as the retraction tube, and the retaining ring of the push tube is fixed on the expanding ring. The expanding ring ensures that the inner and outer diameters of the retaining ring at the proximal end of the retraction tube are consistent with and aligned with the inner and outer diameters of the retaining ring at the proximal end of the push tube.

[0158] Preferably,

[0159] The distal end of the knob housing is provided with a tube channel that passes through the proximal ends of the push tube and the retraction tube;

[0160] The near end of the knob housing is provided with a locking channel through which the far end of the locking head passes.

[0161] The inner wall of the distal end of the conveying pipe is provided with an inner stepped opening;

[0162] The proximal outer wall of the valve constrictor tube is provided with an outer stepped opening, which is matched and connected with the inner stepped opening to form an abutment.

[0163] The positive and progressive effects of this invention are as follows:

[0164] 1) The present invention has only a single knob on the handle housing of the delivery device. This single knob can be used to rotate the push tube to push the delivery tube to deliver the artificial valve in a straight line in the bridge tube sleeve, and can also be used to rotate the retraction tube to drive the outer tube to retract the sheath sleeve in a straight line towards the proximal end to release the artificial valve.

[0165] 2) The present invention provides retaining rings at the proximal ends of the pushing tube and the retraction tube, and respectively engages the retaining rings in the same knob. The pushing tube or the retraction tube is rotated by a single knob, thereby achieving the purpose of forward delivery or retraction.

[0166] 3) This knob, by setting a seesaw and a slider that slides back and forth on the seesaw, can selectively engage the near and far sides of the seesaw in the locking ring at different times, thereby achieving the purpose of truly rotating the push tube or retracting the tube. Attached Figure Description

[0167] Figure 1A This is a side view of the transapical mitral valve replacement delivery device of the present invention;

[0168] Figure 1B This is a schematic cross-sectional view of the transapical mitral valve replacement delivery device of the present invention;

[0169] Figure 2AThis is a schematic diagram of the internal components of the transapical mitral valve replacement delivery device of the present invention, after the outer layer components are hidden.

[0170] Figure 2B for Figure 2A A sectional view;

[0171] Figure 2C This is a schematic diagram of the internal structure of the proximal section of the transapical mitral valve replacement delivery device of the present invention;

[0172] Figure 2D A schematic diagram of the proximal retaining ring of the push tube 30 and the retraction tube 20;

[0173] Figure 3 This is a schematic diagram of the locking head 53 and the core tube 51 of the present invention;

[0174] Figures 4A-4F This is a schematic diagram of the knob 60 and its internal components of the present invention;

[0175] Figures 5A-5C This is a schematic diagram of the outer tube 70 and its related structures according to the present invention;

[0176] Figures 6A-6B This is a structural diagram showing the connection relationship between the valve constriction tube and the delivery tube of the present invention;

[0177] Figures 7A-7B This is a schematic diagram of the structure of the sheath sleeve 90 of the present invention;

[0178] Figure 8 This is a three-dimensional structural diagram of the connector 88 of the present invention. Detailed Implementation

[0179] The following specific examples illustrate the implementation of the present invention. 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, and various 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, unless otherwise specified, the following embodiments and features described therein can be combined with each other.

[0180] In the field of interventional medical devices, "distal" and "distal segment" are defined as the end or segment away from the operator during surgery, while "proximal" and "proximal segment" are defined as the end or segment closer to the operator during surgery.

[0181] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection, an electrical connection, or a communication connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0182] In this invention, "axial" generally refers to the axial direction between the distal and proximal ends, which 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 axial direction of the axisymmetric element itself. "Radial" refers to the direction perpendicular to "axial".

[0183] like Figures 1A-1B Figures 2A to 2C show the 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, from the outside to the inside, comprises a handle housing 10, a retraction tube 20, a push tube 30, a delivery tube 40, a central core tube 51, and a tether 52. A knob 60 and a locking head 53 are also provided at the proximal end. The distal section, from the outside to the inside, comprises the handle housing 10, an outer tube 70, a distal section of the retraction tube 20, a distal section of the push tube 30, a distal section of the delivery tube 40, a distal section of the central core tube 51, and a distal section of the tether 52. From the proximal end to the distal end of the distal section, the outer tube 70, a valve receiving tube 80, and a sheath sleeve 90 are connected in sequence, along with a connector 88 that detachably connects the valve receiving tube 80 and the sheath sleeve 90, and a valve constriction tube 45 fixedly connected to the distal end of the delivery tube 40. The integral connection of the outer tube 70 and the valve receiving tube 80, and the fixed connection of the valve gathering tube 45 and the delivery tube 40 in this invention have two advantages: 1) When the delivery device is withdrawn, the valve gathering tube 45 will not separate from the delivery tube 40, avoiding its retention in the body. 2) When pre-loading the artificial valve, a gathering funnel can be added to the distal end of the valve receiving tube 80, eliminating the need for disassembly and reassembly of the proximal end of the valve receiving tube 80, and also saving the need for an additional valve loader. When loading the artificial valve, the tether can be directly threaded through an external auxiliary device to the proximal end of the delivery device.

[0184] In this example, the handle housing 10 can be a single unit formed by two symmetrical half-shells joined together in an axially symmetrical manner. Several threaded holes can be present on the edge of the housing, and screws are inserted into these symmetrically positioned threaded holes in the two half-shells to connect them. The proximal inner wall of the handle housing 10 has several proximal axial reinforcing ribs, axially fixed to the proximal inner wall of the handle housing; several proximal radial reinforcing ribs 12 are radially fixed to the proximal inner wall of the handle housing; the proximal axial reinforcing ribs and proximal radial reinforcing ribs 12 can be attached to the outer wall of the retraction tube 20 to increase the stability when rotating the retraction tube 20 (see the example described later for details). The distal inner wall of the handle housing 10 has several distal axial reinforcing ribs, axially fixed to the distal inner wall of the handle housing 10; several distal radial reinforcing ribs 14 are radially fixed to the distal inner wall of the handle housing 10; the distal axial reinforcing ribs and distal radial reinforcing ribs 14 can fit against the outer wall of the outer tube 70 and the valve receiving tube 80, so that the outer tube 70 and the valve receiving tube 80 can be retracted horizontally in a straight line (see the example below for details). The proximal outer wall of the handle housing 10 has several corresponding housing slots or housing protrusions 15 (see the example below for details). The distal section of the handle housing has a through-hole, which can be used to view the scale on the delivery tube 40 to determine the delivery position; this example figure is not shown. The middle inner wall of the handle housing 10 has several axially arranged positioning plates 18, which can be engaged with the guide plate 72 at the proximal end of the outer tube 70 to prevent the outer tube 70 from rotating, so that the outer tube 70 can only be moved in a straight line towards the proximal end by the retraction knob.

[0185] Continuing as shown in the figure, in this example, a retraction tube 20 is inserted tightly inside the handle housing 10. The retraction tube 20 is inserted inside the handle housing 10 and can rotate within the handle housing 10. The proximal end of the retraction tube 20 can be connected to the knob 60 by a snap-fit, and the distal end can extend all the way to the proximal end of the outer tube 70, where it is threadedly connected to the outer tube 70. The retraction tube 20 is located inside the proximal section of the handle housing 10 and is sleeved outside the push tube 30. The outer surface of the distal end of the retraction tube 20 has a retraction external thread 21, which is threadedly connected to the retraction internal thread 71 of the outer tube 70 (see the example described later for details). The proximal end of the retraction tube 20 has a retaining ring 22, which is inserted inside the distal end of the knob 60. By means of the retaining ring 22 at the proximal end of the retraction tube 20, the knob 60 can selectively rotate the retraction tube 20. When the retraction tube 20 rotates, its outer wall can fit against the axial and radial reinforcing ribs 12 of the near section of the handle housing 10, which provide support, so that the rotation of the retraction tube 20 will not wobble due to insufficient support in the middle section because of its excessive length.

[0186] like Figure 2DAs shown, in this example, the circumference of the proximal retaining ring 22 of the retraction tube 20 has M evenly distributed notches 23, where M is a natural number ≥ 1. The proximal end of the retaining ring 22 is a proximal ring 221; the distal end of the retaining ring 22 is a distal ring 222; the middle part of the retaining ring 22 consists of M connecting rods 223, the proximal and distal ends of which are fixedly connected to the proximal ring 221 and the distal ring 222 at even intervals, respectively. Two adjacent connecting rods 223 together with the proximal ring 221 and the distal ring 222 form a notch 23. The outer surface of the proximal ring 221 is inclined from the proximal end to the distal end toward the center point of the retaining ring; the outer surface of the distal ring 222 is inclined from the distal end to the proximal end toward the center point of the retaining ring; the outer surface of the connecting rod 223 is inclined from the center line of the surface axis to both sides toward the center point of the retaining ring 22, and the resulting retaining opening 23 is a quadrangular frustum cavity that shrinks toward the center point of the retaining ring 22.

[0187] Continuing as shown in the figure, in this example, the push tube 30 is located within the proximal section of the handle housing 10, passing through the retraction tube 22. The proximal end of the push tube 30 passes through the proximal end of the knob 60, and the proximal end of the push tube 30 and the knob 60 can be connected by a snap-fit ​​mechanism. The knob 60 can selectively rotate the push tube 30. The distal end of the push tube 30 can extend all the way into the proximal end of the outer tube 70, or it is feasible not to extend into the proximal end of the outer tube 70. The inner surface of the push tube 30 has a push internal thread 31. The push internal thread 31 can be engaged with the delivery external thread 41 at the proximal end of the delivery tube 40, and the rotation of the push tube 31 pushes the delivery tube 40 to move linearly to the distal end. The proximal end of the push tube 30 has a retaining ring 32, which passes through the proximal end of the knob 60. Through the retaining ring 32 at the proximal end of the push tube 30, the knob 60 can selectively rotate the push tube 30. The inner and outer diameters of the proximal retaining ring 32 of the push tube 30 are consistent with those of the proximal retaining ring 22 of the retraction tube 20. Since the retraction tube 20 is fitted over the push tube 30, the outer diameter of the push tube 30 is different from that of the retraction tube 20. However, the inner and outer diameters of the retaining rings 22 and 32 at their proximal ends are consistent. Therefore, an expanding ring 34 with the same thickness as the retraction tube 20 can be fixed at the proximal end of the push tube 30. The retaining ring 32 of the push tube 30 is fixed on the expanding ring 34, so that the inner and outer diameters of the proximal retaining ring 32 of the push tube 30 are consistent with and aligned with those of the proximal retaining ring 22 of the retraction tube 20.

[0188] Continue as Figure 2DAs shown, in this example, similar to the proximal retaining ring 22 of the retraction tube 20, the circumferential surface of the proximal retaining ring 32 of the push tube 30 has M evenly distributed slots 33, where M is a natural number ≥ 1. The proximal end of the retaining ring 32 is a proximal ring 321; the distal end of the retaining ring 32 is a distal ring 322; the middle part of the retaining ring 32 has M connecting rods 323, the proximal and distal ends of the connecting rods 323 are fixedly connected to the proximal ring 321 and the distal ring 322 at even intervals, and two adjacent connecting rods 323 together with the proximal ring 321 and the distal ring 322 form a slot 33. The outer surface of the proximal ring 321 is inclined from the proximal end to the distal end toward the center point of the retaining ring; the outer surface of the distal ring 322 is inclined from the distal end to the proximal end toward the center point of the retaining ring; the outer surface of the connecting rod 323 is inclined from the centerline of the surface axis to both sides toward the center point of the retaining ring 32, and the resulting retaining opening 33 is a quadrangular frustum cavity that shrinks toward the center point of the retaining ring 32.

[0189] Continue as Figures 1A-1B as well as Figures 2A-2C As shown, in this example, the proximal section of the delivery tube 40 passes inside the push tube 30. The middle section of the delivery tube 40 passes through the outer tube 70 until its distal end passes through the proximal end of the valve receiving tube 80. The distal end of the delivery tube 40 abuts against the proximal end of the valve constrictor tube 45, which is pre-placed inside the valve receiving tube 80. The outer surface of the proximal end of the delivery tube 40 has a delivery external thread 41, which is engaged with the push internal thread 31 of the push tube 30. The rotation of the push tube 30 can drive the delivery tube 40 to push the valve constrictor tube 45 distally. The outer wall of the delivery tube 40 is provided with a scale, and the delivery progress can be observed through the shell hole at the distal end of the handle housing 10. To prevent the delivery tube 40 from rotating and being carried linearly distally by the rotating push tube 30, the outer ring of the radial section of the distal end of the delivery tube 40 is set to be non-circular. The inner ring of the radial section of the distal section of the outer tube 70 is set to be non-circular, matching the shape and size of the outer ring of the radial section of the distal section of the conveying pipe 40. This design allows the distal section of the conveying pipe 40 to pass inside the distal section of the outer tube 70 and thus prevents it from rotating. The distal section of the outer tube 70 restricts the rotation of the conveying pipe 40, allowing it to move only in a straight line towards the distal end. The outer ring of the radial section of the distal section of the conveying pipe 40 can be designed as a D-shape, a square shape, etc. The shape can be square, polygonal, or even star-shaped, or have several protrusions on the outer surface; any non-circular shape is acceptable. The inner surface of the proximal end of the delivery tube 40 has a proximal support ring 42, which can fit against the outer surface of the proximal segment of the core tube 51, providing support for the core tube 51 and increasing coaxiality (see examples below for details). The inner wall of the distal end of the delivery tube 40 is configured with an inner stepped opening 43, which can form a good mating contact with the valve constriction tube 45 (see examples below for details).

[0190] like Figure 3As shown, in this example, the middle section of the core tube 51 passes through the delivery tube 40, and the proximal end protrudes from the proximal end of the knob 60. The proximal section of the core tube 51 is fitted inside the proximal support ring 42 of the delivery tube 40. The proximal support ring 42 provides support for the core tube 51 and increases coaxiality. The distal end of the core tube 51 is located in the middle or distal section of the delivery tube 40. A distal fixing ring 511 is fitted on the outer wall of the distal end of the core tube 51. A sealing ring 512 is provided on the outer circumferential wall of the distal fixing ring 511. The inner wall of the delivery tube 40 is pressed against the sealing ring 512 at the distal end of the core tube 51 to seal and isolate the artificial valve in the valve receiving tube 45 from the outside.

[0191] Continue as Figure 3 As shown, in this example, the distal end of the locking head 53 is rotatably connected to the proximal end of the knob 60. This rotatable connection between the distal end of the locking head 53 and the proximal end of the knob 60 can be consistent with the rotatable connection between the knob 60 and the handle housing 10, allowing the knob 60 to rotate without the locking head 53 needing to rotate with it. For example, the distal end of the locking head 53 has a locking protrusion 532, which is embedded in the locking groove 66 of the knob 60; or the distal end of the locking head 53 has a locking groove in which the locking protrusion of the knob 60 is embedded. A locking knob 531 with a sealing ring is provided in the middle section of the locking head 53, and a nut (not shown) is provided at the proximal end of the locking head 53. The proximal end of the central core tube 51 is fixed within the distal end of the locking head 53.

[0192] Continue as Figure 3 As shown, in this example, the middle section of the tether 52 is inserted into the core tube 51, the distal end of the tether 52 passes through the core tube 51 and connects 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 nut.

[0193] like Figures 4A-4F As shown, in this example, the distal end of the knob 60 is movably connected to the proximal end of the handle housing 10. The knob 60 has a knob housing 61, N rocker arms 62, N sliders 63, and washers (not shown). N is a natural number ≥ 1, and N ≤ M. In this example, N is 2. The distal end of the knob housing 61 has a tube channel that passes through the proximal ends of the push tube 30 and the retraction tube 20, allowing the push tube 30 and the retraction tube 20 to pass through. The proximal end of the knob housing 61 has a locking channel through which the distal end of the locking head 53 passes, and the central core rod 51 passes.

[0194] In this example, the inner wall of the distal end of the knob 60 has several shell grooves 65; the outer wall of the proximal end of the handle shell 10 has several corresponding shell protrusions 15. The knob 60 is screwed onto the proximal end of the handle shell 10 by the shell protrusions 15 of the handle shell 10 being fitted into the shell grooves 65 of the knob 60. Another example, not shown in the figures, is that the inner wall of the distal end of the knob 60 has several shell protrusions; the outer wall of the proximal end of the handle shell 10 has several corresponding shell grooves. The knob 60 is screwed onto the proximal end of the handle shell 10 by the shell protrusions 15 of the knob being fitted into the shell grooves of the handle shell 10. This method also achieves the purpose of the present invention.

[0195] In this example, the inner wall of the proximal end of the knob 60 has several locking grooves 66; the outer wall of the distal end of the locking head 53 has several corresponding locking protrusions 532. The locking protrusions 532 of the locking head 53 are fitted into the locking grooves 66 of the knob, thereby screwing the proximal end of the knob 60 onto the distal end of the locking head 53. This allows the knob 60 to rotate without the locking head 53 needing to rotate with it. Another example, not shown in the figures, is that the inner wall of the proximal end of the knob 53 has several locking protrusions; the outer wall of the distal end of the locking head 53 has several corresponding locking grooves. The locking protrusions of the knob 60 are fitted into the locking grooves of the locking head 53, thereby screwing the proximal end of the knob onto the distal end of the locking head. This method also achieves the purpose of the present invention.

[0196] The knob housing 61 is generally cylindrical and hollow inside, with N outer wall grooves 611 on the upper part, roughly waist-shaped. The inner side of each outer wall groove 611 is a small waist-shaped groove 6111, located in the middle of the housing wall, where the waist post 632 of the slider 63 is slidably engaged. The outer side of each outer wall groove 611 is a large waist-shaped groove 6112, corresponding to and communicating with the small waist-shaped groove 6111, which accommodates the push block 631 of the slider 63. N inner wall grooves 612 are located at positions corresponding to and communicating with the outer wall grooves 611, and the rocker arm 62 is located within each inner wall groove 612. Pivot holes 6121 are provided on both sides of each inner wall groove 612, and the two ends of the rocker arm 621 pass through the pivot holes 6121 on both sides of the inner wall groove 612. A washer (not shown in the figure) is provided in the middle of the rocker arm 62 in the inner cavity of the knob housing 61. The washer is sleeved on the outside of the push tube 30 and the retraction tube 20, and is located between the proximal retaining ring 32 of the push tube 30 and the proximal retaining ring 22 of the retraction tube 20, in order to reduce friction during rotation.

[0197] like Figure 4EAs shown, the rocker arm 62 is pivotally mounted in the inner wall groove 612 of the knob housing 61 and located at the corresponding position in the outer wall groove 611. The proximal and distal ends of the rocker arm 62 can be engaged in the slot 33 of the proximal retaining ring 32 of the push tube 30 or in the slot 23 of the proximal retaining ring 22 of the retraction tube 20. The rocker arm 62 has a rocker arm that is short and U-shaped, and is arranged parallel to the axial direction of the knob housing 61. The proximal and distal ends of the rocker arm can be engaged in the slot 33 of the proximal retaining ring 32 of the push tube 30 or in the slot 23 of the proximal retaining ring 22 of the retraction tube 20. The rocker shaft 621 extends vertically from the middle of the two sides of the rocker arm and passes through the pivot hole 6121 in the inner wall of the knob housing 61. The rocker arm has a bottom rocker arm 622, which is concave outward. A rocker shaft 621 extends vertically from the midpoint of both sides of the bottom rocker arm 622. Proximal arms 623 extend from the proximal end of the bottom rocker arm 622 at a certain angle. Distal arms 624 extend from the distal end of the bottom rocker arm 622 at a certain angle. The proximal arms 623 can be engaged in the locking slot 33 of the proximal locking ring 32 of the push tube 30; the distal arms 624 can be engaged in the locking slot 23 of the proximal locking ring 22 of the retraction tube 20. Specifically, the bottom rocker arm 622 is composed of a midpoint 6221, a proximal bottom arm 6222, and a distal bottom arm 6223. Midpoint 6221 is located at the center of bottom arm 622; the proximal bottom arm 6222 extends integrally from midpoint 6221 towards its proximal end, and the proximal side arm 623 extends integrally from the proximal end of the proximal bottom arm 6222 at a certain angle; the distal bottom arm 6223 extends integrally from midpoint 6221 towards its distal end, and the distal side arm 624 extends integrally from the distal end of the distal bottom arm 6223 at a certain angle; with midpoint 6221 as the apex, the included angle α between the proximal bottom arm 6222 and the distal bottom arm 6223 is 130–180°, preferably 150–160°. The proximal side arm 623 extends integrally from the proximal end of the proximal bottom arm 6222 at a certain angle β. The distal side arm 624 also extends integrally from the distal end of the distal bottom arm 6223 at a certain angle β, where β is 70–100°, preferably 75–90°. The four arm faces of the proximal arm 623 have progressively inclined primary, secondary, and tertiary arm faces near the end face, which mate with the frustum-shaped cavity of the locking jaw 33 of the retaining ring 32, making it easier to engage with the locking jaw 33 of the proximal retaining ring 32 of the push tube 30. Similarly, the four arm faces of the distal arm 624 have progressively inclined primary, secondary, and tertiary arm faces near the end face, which mate with the frustum-shaped cavity of the locking jaw 23 of the retaining ring 22, making it easier to engage with the locking jaw 23 of the proximal retaining ring 22 of the retraction tube 20.

[0198] like Figure 4FAs shown, in this example, slider 63 is respectively engaged in the outer wall groove 611 of the knob housing 61. Slider 63 can slide back and forth between the distal and proximal ends within the outer wall groove 611. The inner end of slider 63 slides back and forth between the proximal and distal ends of rocker arm 62, so that the proximal arm 623 of the proximal end or the distal arm 624 of the distal end of rocker arm 62 can switch back and forth to rise and fall. During the rising and falling process, the proximal arm 623 of the proximal end of rocker arm 62 can be engaged in the slot 33 of the proximal retaining ring 32 of the push tube 30, or the distal arm 624 of the distal end can be engaged in the slot 23 of the proximal retaining ring 22 of the retraction tube 20. The outer end of slider 63 is a push block 631, which is roughly waist-shaped. Several protrusions are distributed on the outer side wall of push block 631 to increase friction, making it easy to push without slipping. The push block 631 is located in the large waist-shaped groove 6112 on the outer side of the outer wall groove 611 of the knob housing 61. The width of the push block 631 is greater than the narrowest width of the outer wall groove 611 of the knob housing 61. The middle part of the slider 63 is a waist column 632, one end of which is fixedly connected to the inner side wall of the push block 631. The outer diameter of the waist column 632 is smaller than the narrowest width of the outer wall groove 611 of the knob housing 61, and it is movably locked in the narrowest part of the outer wall groove 611 of the knob housing 61, i.e., the small waist-shaped groove 6111. The inner end of the slider 63 is a stop block 633, one end of which is fixedly connected to the other end of the waist column 632. The outer diameter of the stop block 633 is greater than the narrowest width of the outer wall groove 611 of the knob housing 61, and the other end of the stop block 633 abuts against the rocker arm 62, and can slide back and forth between the near bottom arm 6222 or the far bottom arm 6223 of the rocker arm 62. The abutment 633 has a cylindrical section 6331 and a hemispherical section 6332. One end of the cylindrical section 6331 is fixedly connected to the other end of the waist column 632. The hemispherical section 6332 extends integrally from the other end of the cylindrical section 6331, and the spherical surface of the hemispherical section 6332 abuts against the near bottom arm 6222 or the far bottom arm 6223 of the seesaw lever 62.

[0199] The working principle of the knob 60 in this example is as follows: when the push block 631 outside the slider 63 is pushed to the far end of the large waist-shaped groove 6112, the slider 63 abutment 633 located inside slides onto the far bottom arm 6223 of the rocker arm 62, thereby pressing the distal arm 624, which is integrally formed with the far bottom arm 6223, into the locking slot 23 of the retaining ring 22 of the retraction tube 20; at this time, the rocker arm 62 of the knob 60 is not engaged with the retaining ring of the push tube 30. When the knob 60 is rotated, the retraction tube 20 can be rotated while the push tube 30 does not rotate, thereby allowing the outer tube 70 to be retracted linearly to the proximal end. When the push block 631 outside the slider 63 is pushed in the opposite direction to the proximal end of the large waist-shaped groove 6112, the inner slider 63 abutment 633 slides onto the near bottom arm 6222 of the rocker arm 62, thereby pressing the proximal arm 623, which is integrally formed with the near bottom arm 6222, into the locking slot 33 of the retaining ring 32 of the push tube 30; at this time, the rocker arm 62 of the knob 60 is not engaged with the retaining ring 22 of the retraction tube 20. When the knob 60 is rotated, the push tube 30 can be rotated while the retraction tube 20 does not rotate, thus allowing the conveying tube 40 to be pushed linearly to the far end. When N=2, if the retraction tube 20 or the push tube 30 needs to be rotated, all sliders 63 need to be pushed to the far end or proximal end of the large waist-shaped groove 6112 simultaneously to achieve the purpose of rotating the retraction tube 20 or the push tube 30.

[0200] like Figures 5A-5CAs shown, in this example, the outer tube 70 is non-rotatably inserted into the distal section of the handle housing 10, with the distal section of the handle housing 10 fitted over the outer tube 70. The distal end of the push tube 30 can extend all the way into the proximal end of the outer tube 70, i.e., the outer tube 70 is located between the distal section of the handle housing 10 and the distal end of the push tube 30. Of course, it is also feasible for the push tube 30 not to extend into the proximal end of the outer tube 70. However, a delivery tube 40 extending from the distal end of the push tube 30 is inserted into the outer tube 70. A tube hole also penetrates the wall of the outer tube 70, and the position of the tube hole corresponds to the housing hole of the handle housing 10. The scale on the wall of the delivery tube 40 can be observed through the housing hole and the tube hole, but it is not shown in the example figure. The proximal section of the outer tube 70 is fitted over the distal section of the retraction tube 20. The inner surface of the outer tube 70 has a retraction internal thread 71, which engages with the retraction external thread 21 of the retraction tube 20 located in the proximal cavity of the handle housing 10, so that the outer tube 70 is pulled linearly towards the proximal end by the rotation of the retraction tube 20. The distal axial reinforcing rib and distal radial reinforcing rib 14 of the distal section of the handle housing 10 are attached to the outside of the outer tube 70 to support the outer tube 70 during retraction. The proximal outer wall of the outer tube 70 has several axially arranged guide plates 72; the guide plates 72 can be locked onto the positioning plate 18 on the distal inner wall of the handle housing 10, so that the outer tube 70 is prevented from rotating during retraction and can only be moved linearly towards the proximal end by the retraction tube 20. The distal end of the outer tube 70 is the distal tube 73, and the outer wall of the distal tube 73 has a pair of cut holes 74. The distal tube 73 of the outer tube 70 can be inserted into the proximal end of the valve receiving tube 80, and the cut holes 74 thereon are used for fixed connection with the valve receiving tube 80.

[0201] In this example, the distal section of the outer tube 70 allows the distal section of the conveying tube 40 to pass through. To prevent the conveying tube 40 from rotating and instead allow it to move linearly towards the distal end only by the pusher tube 30, the inner circle of the radial section of the distal section of the outer tube 70 is designed to match the outer circle of the conveying tube 40 in a non-circular shape and size. For example, if the outer circle of the radial section of the distal section of the conveying tube 40 is D-shaped, then the inner circle of the radial section of the distal section of the outer tube 70 is also designed to be D-shaped. This prevents the conveying tube 40 from rotating under the constraint of the distal section of the outer tube 70. Similarly, if the outer circle of the radial section of the distal section of the conveying tube 40 is designed to be U-shaped... If the outer tube has a square or polygonal shape, several protrusions, a star shape, etc., then the inner ring of the radial section of the outer tube at the far end of 70mm is also designed to be U-shaped accordingly. The conveying pipe 40 of this invention can be non-rotatable, whether it is a shape, square or polygonal, has several indentations, star-shaped, etc., as long as the cross-sectional shape is not circular.

[0202] like Figures 6A-6BAs shown, in this example, the valve receiving tube 80 is generally circular, with a valve constriction tube 45 pre-installed inside. The distal end of the delivery tube 40 extends into the proximal end of the valve receiving tube 80 and connects to the proximal end of the pre-installed valve constriction tube 45. The distal segment 73 of the outer tube 70 is inserted into the stepped hole of the proximal flange tube 81 of the valve receiving tube 80. The connection between the distal segment 73 of the outer tube 70 and the proximal end of the valve receiving tube 80 has a cavity sealing gasket (not shown in the figure), and the cavity sealing gasket is fitted around the distal segment of the delivery tube 40, and the distal segment 73 of the outer tube 70 presses the cavity sealing gasket against the step of the stepped hole at the proximal end of the valve receiving tube 80.

[0203] The proximal end of the valve receiving tube 80 is a flange tube 81, which passes through the distal section 73 of the outer tube 70. The flange tube 81 has a pair of through holes 82 at corresponding positions. A pair of fixing pins 83 pass through the through holes 82 of the valve receiving tube 80 and the cut holes 74 of the outer tube 70, respectively, thus fixing the valve receiving tube 80 to the distal end of the outer tube 70. This allows the outer tube 70 to retract stably without the valve receiving tube 80 falling off. The inner wall of the flange tube 81 and the outer wall of the distal section 73 can be further bonded with adhesive to stably fix the valve receiving tube 80 to the distal end of the outer tube 70 and seal the interior of the valve receiving tube 80. This fixing connection method avoids disassembly and improves system stability and sealing.

[0204] In a preferred example, the outer surface of the valve receiving tube 80 has external reinforcing ribs with indicator markings, such as a "K"-shaped marking. Since the mitral valve annulus is not circular but rather a D-shaped structure, the external support of the artificial mitral valve is also D-shaped to match the human anatomy. To better install the artificial mitral valve onto the mitral valve, a "K"-shaped structure is provided on the outer surface of the valve receiving tube as an indicator of valve orientation. In this example, an axial protrusion 85 is provided on the distal outer surface of the valve receiving tube 80, thereby preventing relative rotation between the valve receiving tube 80 and the sheath sleeve 90, as detailed in the example described later.

[0205] In this example, the valve constriction tube 45 is a hollow tube, pre-placed within the valve receiving tube 80. The interior of the valve constriction tube 45 has a funnel-shaped structure with the opening facing distally, allowing for the compression of an artificial valve. When pre-contracting the artificial valve, the proximal end of the valve is constricted at the funnel-shaped structure, while the remaining portion resides within a larger space within the valve receiving tube 80. The proximal outer wall of the valve constriction tube 45 is provided with an outer stepped opening 451, and the inner stepped opening 43 of the delivery tube 40 is fitted onto the outer stepped opening 451 of the valve constriction tube 45 to form an abutment. In another example, the proximal inner wall of the valve constriction tube 45 is provided with an inner stepped opening, and the distal outer wall of the delivery tube 40 is provided with an outer stepped opening, with the inner stepped opening of the valve constriction tube 45 fitted onto the outer stepped opening of the delivery tube 40 to form an abutment. This method also achieves the objective of the present invention.

[0206] Figures 7A-7BAs shown, in this example, the sheath sleeve 90 serves as the delivery channel for the artificial valve and is connected to the distal end of the valve receiving tube 80. When the push tube 30 rotates, it drives the delivery tube 40 to push the valve constriction tube 45 along the central axis of the sheath sleeve 90 towards the distal end, delivering the artificial valve. 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 80 is inserted into the cavity of the sheath base 91. The distal end of the cavity has a stepped opening, and a sheath sealing gasket (not shown) is provided at the stepped opening of the sheath base 91 of the sheath sleeve 90. The distal end of the valve receiving tube 80 is pressed against the sheath sealing gasket, and the sheath sealing gasket seals the distal end of the valve receiving tube 80 within the sheath base 91 of the sheath sleeve 90. To prevent relative rotation between the valve receiving tube 80 and the sheath sleeve 90 during delivery and retraction, this example has an axial groove 911 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 fits over the distal end of the valve receiving tube 80, and the axial protrusion 85 of the valve receiving tube 80 is engaged with the axial groove 911 of the sheath sleeve 90 to prevent relative rotation. In another example not shown, an axial protrusion can also 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 80. The proximal end of the sheath sleeve 90 fits over the distal end of the valve receiving tube 80, and the axial protrusion of the sheath sleeve 90 is engaged with the axial groove of the valve receiving tube 80 to prevent relative rotation. Although this example is not shown, it also achieves the purpose of the invention. The proximal end of the inner sheath 92 is connected to the distal end of the sheath base 91. An outer sheath 93 is fitted over an inner sheath 92. The inner wall of the inner sheath 92 has a smoother surface and a higher hardness 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 example, the outer wall of the outer sheath 93 has graduations to determine the retraction endpoint, and the distal end of the outer sheath 93 has a developing ring 95, the retraction position being determined by the developing ring 95 and the graduations.

[0207] Figure 8 As shown, in this example, the connector 88 is provided to ensure a more secure insertion of the distal end of the valve receiving tube 80 into the proximal end of the sheath sleeve 90. The connector 88 is fitted around the periphery where the distal end of the valve receiving tube 80 connects to the proximal end of the sheath sleeve 90. The connector 88 is similar in shape to a cylinder and can be composed of two symmetrically fitted semi-cylindrical shells, with the side walls fixed together by bolts. Both ends of the connector 88 are detachably connected to the valve receiving tube 80 and the sheath sleeve 90, respectively, thus securely connecting the valve receiving tube 80 and the sheath sleeve 90 together.

[0208] The solution provided in this example is that the connector 88 is detachably connected at both ends to the valve receiving tube 80 and the sheath sleeve 90, respectively. Specifically, the outer surface of the middle section of the valve receiving tube 80 has an external thread 86; the inner surface of the proximal end of the connector 88 has an internal thread 87. The external thread 86 of the valve receiving tube 80 and the internal thread 87 of the connector 88 are engaged to connect the connector 88, thereby fitting the connector 88 onto the outside of the valve receiving tube 80. The inner surface of the distal end of the connector 88 has a hook protrusion 89; the outer surface of the sheath base 91 at the proximal end of the sheath sleeve 90 has a tube protrusion 912. The tube protrusion 912 of the sheath sleeve 90 is hooked onto the hook protrusion 89 of the connector 88, thereby fitting the connector 88 onto the proximal end of the sheath sleeve 90. This method also only requires rotating the connector 88 so that the internal thread 87 of the connector 88 disengages from the external thread 86 of the valve receiving tube 80, thus separating the valve receiving tube 80 from the sheath sleeve 90.

[0209] Another example (not shown) could be that the outer surface of the middle section of the valve receiving tube 80 has a ring of tube protrusions; the inner surface of the proximal end of the connector 88 has a ring of hook protrusions. The tube protrusions of the valve receiving tube 80 hook onto the hook protrusions of the proximal end of the connector 88, thereby fitting the connector 88 onto the outside of the valve receiving tube 80. The outer surface of the proximal end of the sheath base 91 of the sheath sleeve 90 has external threads; the inner surface of the distal end of the connector 88 has internal threads. The external threads of the sheath sleeve 90 are engaged with the internal threads of the connector 88, thereby fitting the connector 88 onto the proximal end of the sheath sleeve 90. In this way, the valve receiving tube 80 and the sheath sleeve 90 can be disassembled simply by rotating the connector 88, causing the internal threads of the connector 88 to disengage from the external threads of the sheath sleeve 90. Although not shown in the figure, this example can also achieve the purpose of the present invention.

[0210] The steps for using the transapical mitral valve replacement delivery device of the present invention are as follows:

[0211] S1. Load the external funnel into the distal end of the valve receiving tube 80, load the artificial mitral valve into the valve receiving tube 80, and remove the funnel.

[0212] S2. Connect the valve receiving tube 80 to the sheath sleeve 90 via the connector 88. The tether 52 passes through the central tube 51 and extends out into the locking head 53 at the proximal end, ready for use.

[0213] S3. Push slider 63 to the proximal end, the proximal arm of rocker arm 62 presses into the retaining ring of the proximal end of push tube 30, rotate knob 60 to rotate push tube 30. The push internal thread 31 of push tube 30 is threadedly connected to the delivery external thread 41 of delivery tube 40, causing delivery tube 40 to move axially and linearly towards the distal end. Since the distal end of delivery tube 40 abuts against valve constrictor tube 45, it pushes valve constrictor tube 45 and the artificial mitral valve inside to move linearly towards the distal end until it reaches the distal end of sheath sleeve 90.

[0214] S4. Prepare for the release of the artificial valve. Rotate the locking knob on the locking head 53 to lock the tether 52, preventing the artificial valve from being ejected from the delivery device and impacting the inner wall of the heart due to excessive force during the release process.

[0215] S5. Push the slider 63 to the distal end, press the distal arm of the rocker arm 62 into the slot of the proximal retaining ring of the retraction tube 20, rotate the knob 60 to drive the retraction tube 20 to rotate, and the outer tube 70 moves axially (towards the proximal end) without rotating. The outer tube 70 drives the valve receiving tube 80 and the sheath sleeve 90 to retract to the proximal end in sequence, gradually releasing the artificial valve.

[0216] The specific embodiments described herein are merely illustrative of the spirit of the invention. Those skilled in the art to which this invention pertains may make various modifications or additions to the described specific embodiments or use similar methods to substitute them, without departing from the spirit of the invention or exceeding the scope defined by the appended claims.

Claims

1. A transapical mitral valve replacement delivery device, characterized in that... have: One handle casing; A knob, the distal end of which is movably connected to the proximal end of the handle housing; A push tube is provided in the proximal section of the handle housing, the proximal end of the push tube passes through the proximal end of the knob, and the inner surface of the push tube has a push internal thread; A delivery tube is inserted into the push tube at its proximal end. The outer surface of the delivery tube has a delivery external thread, which is connected to the push internal thread. A retraction tube is provided inside the proximal section of the handle housing and sleeved outside the push tube. The proximal end of the retraction tube passes through the distal end of the knob, and the outer surface of the distal end of the retraction tube has a retraction external thread. An outer tube is non-rotatably disposed inside the distal section of the handle housing and its proximal section is sleeved outside the distal section of the retraction tube. The inner surface of the outer tube has a retraction internal thread, and the retraction external thread is engaged with the retraction internal thread. The distal section of the delivery tube is non-rotatably inserted inside the distal section of the outer tube. A valve constrictor tube, the proximal end of which abuts against the distal end of the delivery tube; A valve receiving tube, with the valve constricting tube pre-installed inside, the proximal end of the valve receiving tube connected to the distal end of the outer tube; A sheath sleeve is detachably connected to the distal end of the valve receiving tube; The push tube and the retraction tube are respectively fixed with a retaining ring with a locking slot at their proximal ends. The knob is equipped with a rocker arm and a slider. By sliding the slider, the proximal or distal side wall of the rocker arm can be selectively locked into the locking slot of the corresponding retaining ring, thereby selecting to drive the push tube or the retraction tube.

2. The transapical mitral valve replacement delivery device as described in claim 1, characterized in that... It also has: A core tube is inserted inside the conveying pipe; A rope is threaded through the core tube; A locking head is movably connected to the proximal end of the knob, the proximal end of the central tube extends and is fixed inside the locking head, and the tether extends from the proximal end of the central tube and passes through the proximal end of the locking head.

3. The transapical mitral valve replacement delivery device as described in claim 2, characterized in that: The inner surface of the proximal end of the delivery tube has a proximal support ring, through which the core tube passes and fits within the proximal support ring; A distal fixing ring is fixed on the distal outer surface of the core tube, and the outer surface of the distal fixing ring has a sealing ring. The delivery tube is tightly fitted on the distal fixing ring.

4. The transapical mitral valve replacement delivery device as described in claim 2, characterized in that: The outer tube has a distal section tube, and the outer wall of the distal section tube has a pair of cut holes; The proximal section of the valve receiving tube has a flange tube, and a pair of through holes are located at corresponding positions on the side wall of the flange tube. A stepped hole is located inside the flange tube. The distal section of the outer tube abuts against the stepped hole of the flange tube in the proximal section of the valve receiving tube, and is fixed by a pair of fixing pins passing through the perforation and cut hole, thereby fixing the distal section of the outer tube through the stepped hole in the proximal section of the valve receiving tube.

5. The transapical mitral valve replacement delivery device as described in claim 4, characterized in that: A cavity sealing gasket is provided at the bottom of the stepped hole, and the distal section of the outer tube is sealed and fixed by the cavity sealing gasket and inserted into the stepped hole of the proximal section of the valve receiving tube.

6. The transapical mitral valve replacement delivery device according to claim 1, characterized in that, The distal outer surface of the valve receiving tube has 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 fitted over the distal end of the valve receiving tube. The axial protrusion of the valve receiving tube is embedded in the axial groove of the sheath sleeve to form a snap-fit.

7. The transapical mitral valve replacement delivery device according to claim 1, characterized in that, The distal outer surface of the valve receiving 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 fitted over the outer side of the distal end of the valve receiving tube. The axial protrusion of the sheath sleeve is embedded in the axial groove of the valve receiving tube to form a snap-fit.

8. The transapical mitral valve replacement delivery device according to claim 1, characterized in that, The transapical mitral valve replacement delivery device also has: A connector is provided, with its two ends detachably connected to the valve receiving tube and the sheath sleeve, respectively, thereby connecting the valve receiving tube and the sheath sleeve together.

9. The transapical mitral valve replacement delivery device according to claim 8, characterized in that, The outer surface of the middle section of the valve receiving tube has external threads; The inner surface of the proximal end of the connector has an internal thread, which is connected to the valve receiving tube by the external thread of the valve receiving tube and the internal thread of the connector, thereby fitting the connector onto the outside of the valve receiving tube. The distal inner surface of the connector has a ring of hooks and protrusions; The outer surface of the proximal end of the sheath sleeve has a tube protrusion. The tube protrusion of the sheath sleeve is hooked onto the hook protrusion of the connector, thereby fitting the connector onto the outside of the proximal end of the sheath sleeve.

10. The transapical mitral valve replacement delivery device according to claim 8, characterized in that, The outer surface of the middle section of the valve receiving tube has a ring of tube protrusions; The inner surface of the proximal end of the connector has a ring of hooks and protrusions. The tube protrusion of the valve receiving tube hooks onto the hooks and protrusions of the connector, thereby fitting the connector onto the outside of the valve receiving tube. The outer surface of the proximal end of the sheath sleeve has external threads; The distal inner surface of the connector has an internal thread, and the external thread of the sheath sleeve is engaged with the internal thread of the connector, thereby fitting the connector onto the proximal outside of the sheath sleeve.

11. The transapical mitral valve replacement delivery device according to claim 1, characterized in that, The sheath sleeve has: A sheath base is located at the proximal end of the sheath sleeve, and the sheath base of the sheath sleeve is connected to the distal end of the valve receiving tube. An inner sheath, the proximal end of which is connected to the distal end of the sheath base; An outer sheath is fitted over the inner sheath, and the proximal end of the outer sheath is connected to the distal end of the sheath base.

12. The transapical mitral valve replacement delivery device according to claim 11, characterized in that, The sheath base of the sheath sleeve has a sheath sealing gasket, through which the distal end of the valve receiving tube is sealed to the proximal end of the sheath sleeve.

13. The transapical mitral valve replacement delivery device as described in claim 1, characterized in that, The outer wall near the proximal end of the outer tube has several axially arranged guide plates; The inner wall of the handle housing has several axially arranged positioning plates, and the guide plate can be locked on the positioning plates, so that the outer tube is non-rotatably located in the distal section of the handle housing.

14. The transapical mitral valve replacement delivery device according to claim 1, characterized in that, The outer ring of the radial section of the distal section of the conveying pipe is non-circular; The inner circle of the radial section of the distal section of the outer tube is a non-circular shape and size that matches the outer circle of the radial section of the distal section of the conveying tube, so that the distal section of the conveying tube is non-rotatably inserted into the distal section of the outer tube.

15. The transapical mitral valve replacement delivery device according to claim 14, characterized in that, The outer ring of the radial cross-section of the distal section of the conveying pipe is D-shaped or square-shaped. Shaped like a square; The inner ring of the radial section of the distal section of the outer tube is D-shaped or U-shaped. Shaped like a square or rectangular shape.

16. The transapical mitral valve replacement delivery device according to claim 14, characterized in that, The outer circumference of the radial cross-section of the distal section of the conveying pipe is polygonal; The inner circle of the radial section of the far section of the outer tube is a polygon.

17. The transapical mitral valve replacement delivery device according to claim 1, characterized in that, The distal inner wall of the handle housing has: Several distal axial reinforcing ribs are axially fixed to the distal inner wall of the handle housing; Several distal radial reinforcing ribs are radially fixed to the distal inner wall of the handle housing; The distal axial reinforcing rib and the distal radial reinforcing rib can be attached to the outer wall of the outer tube and the valve receiving tube.

18. The transapical mitral valve replacement delivery device according to claim 1, characterized in that, The proximal inner wall of the handle housing has: Several proximal axial reinforcing ribs are axially fixed to the proximal inner wall of the handle housing; Several radial reinforcing ribs are radially fixed to the inner wall of the proximal section of the handle housing; The proximal axial reinforcing rib and the proximal radial reinforcing rib can be attached to the outer wall of the retraction tube.

19. The transapical mitral valve replacement delivery device according to claim 2, characterized in that, The locking head has a locking knob with a sealing ring on the middle section, and a nut is provided at the near end of the locking head; The proximal end of the tether extends from the proximal end of the locking head and can be locked by the locking knob and / or the nut.

20. The transapical mitral valve replacement delivery device according to claim 11, characterized in that, The outer sheath has graduations on its outer wall and a imaging ring at its distal end; the inner sheath has a smoother and harder inner wall than the outer sheath.

21. The transapical mitral valve replacement delivery device according to claim 1, characterized in that, The inner wall of the distal end of the knob has several shell grooves; The outer wall of the near end of the handle housing has several corresponding shell protrusions. The shell protrusions of the handle housing are embedded in the shell groove of the knob, thereby screwing the knob into the near end of the handle housing.

22. The transapical mitral valve replacement delivery device according to claim 1, characterized in that, The inner wall of the distal end of the knob has several shell-shaped protrusions; The outer wall of the near end of the handle housing has several corresponding housing slots. The housing protrusion of the knob is embedded in the housing slot of the handle housing, thereby rotating the knob to the near end of the handle housing.

23. The transapical mitral valve replacement delivery device according to claim 1, characterized in that, The inner wall of the near end of the knob has several locking grooves; The distal outer wall of the locking head has several corresponding locking protrusions. The locking protrusions of the locking head are embedded in the locking groove of the knob, thereby screwing the proximal end of the knob onto the distal end of the locking head.

24. The transapical mitral valve replacement delivery device according to claim 1, characterized in that, The inner wall of the near end of the knob has several locking protrusions; The distal outer wall of the locking head has several corresponding locking grooves. The locking protrusion of the knob is embedded in the locking groove of the locking head, thereby rotating the proximal end of the knob to the distal end of the locking head.

25. The transapical mitral valve replacement delivery device according to claim 1, characterized in that, The outer diameter of the proximal retaining ring of the retraction tube is consistent with the outer diameter of the proximal retaining ring of the push tube. The proximal retaining ring of the push tube can be engaged with the proximal end inside the knob, and the proximal retaining ring of the retraction tube can be engaged with the distal end inside the knob.

26. The transapical mitral valve replacement delivery device as described in claim 25, characterized in that... The proximal retaining ring of the push tube and the proximal retaining ring of the retraction tube each have M evenly distributed retaining holes on their circumferential surfaces, where M is a natural number ≥ 1. The knob has: A knob housing with N waist-shaped grooves on the upper part; N rocker arms are pivotally mounted inside the knob housing and located at corresponding positions in the outer wall groove. The proximal and distal ends of the rocker arms can be selectively locked in the slot of the proximal end retaining ring of the push tube or the slot of the proximal end retaining ring of the retraction tube. N sliders are respectively locked in the outer wall groove of the knob housing. The inner end of the slider is switched back and forth between the near end and the far end of the rocker arm, so that the near end of the rocker arm is locked in the slot of the near end retaining ring of the push tube, or the far end of the rocker arm is locked in the slot of the near end retaining ring of the retraction tube. Where N is a natural number ≥ 1, and M ≥ N.

27. The transapical mitral valve replacement delivery device as described in claim 26, characterized in that... The retaining ring has: The proximal end of the retaining ring is a proximal end ring; The distal end of the retaining ring is a distal ring; The middle part of the retaining ring consists of M connecting rods. The proximal and distal ends of the connecting rods are fixedly connected to the proximal ring and the distal ring at even intervals, respectively. Two adjacent connecting rods together with the proximal ring and the distal ring form the retaining opening.

28. The transapical mitral valve replacement delivery device as described in claim 27, characterized in that... The outer surface of the proximal ring slopes from the proximal end to the distal end toward the center point of the retaining ring; The outer surface of the distal ring slopes from the distal end to the proximal end toward the center point of the retaining ring; The outer surface of the connecting rod slopes from the centerline of the surface axis to both sides towards the center point of the retaining ring, thereby forming a truncated quadrangular cavity that narrows towards the center point of the retaining ring.

29. The transapical mitral valve replacement delivery device as described in claim 26, characterized in that, The seesaw has the following characteristics: A rocker arm, which is short and U-shaped, is arranged parallel to the axial direction of the knob housing. The proximal end and distal end of the rocker arm can be selectively locked in the slot of the proximal end retaining ring of the push tube or the slot of the proximal end retaining ring of the retraction tube. Two rocker arms extend vertically from the middle of the two sides of the rocker arm, and the rocker arms pass through the inner wall of the knob housing.

30. The transapical mitral valve replacement delivery device as described in claim 29, characterized in that... The rocker arm has: A bottom arm with an outward concave shape, and the bottom axis extends vertically from the midpoint of the two sides of the bottom arm; The proximal arms extend from the proximal end of the bottom arm at a certain angle; The distal arms extend from the distal end of the bottom arm at a certain angle; The proximal arm and the distal arm can be selectively locked in the slot of the proximal retaining ring of the push tube or the slot of the proximal retaining ring of the retraction tube.

31. The transapical mitral valve replacement delivery device as described in claim 30, characterized in that... The tilting arm is divided into: The midpoint is located at the center of the bottom-hanging arm; A near-bottom arm extends integrally from the midpoint toward the proximal end, and a near-side arm extends integrally from the proximal end of the near-bottom arm at a certain angle; A distal bottom arm extends integrally from the midpoint toward the distal end, and a distal side arm extends integrally from the distal end of the distal bottom arm at a certain angle. With the midpoint as the corner vertex, the angle α between the near bottom arm and the far bottom arm is 130~180°.

32. The transapical mitral valve replacement delivery device as described in claim 31, characterized in that... The included angle α is 150~160°.

33. The transapical mitral valve replacement delivery device as described in claim 31, characterized in that, The proximal arm extends integrally from the proximal end of the proximal arm at an angle β. The distal arm extends integrally from the distal end of the distal bottom arm at a certain angle β, where β is 70~100°.

34. The transapical mitral valve replacement delivery device as described in claim 33, characterized in that, β is 75~90°.

35. The transapical mitral valve replacement delivery device as described in claim 30, characterized in that... The four arm faces of the proximal and distal arms have progressively inclined first-level arm faces, second-level arm faces, third-level arm faces, and so on up to the end face, making it easier to engage with the slot of the proximal retaining ring of the push tube or the slot of the proximal retaining ring of the retraction tube.

36. The transapical mitral valve replacement delivery device as described in claim 26, characterized in that... The outer end of the slider is a push block, located outside the outer wall groove of the knob housing. The width of the push block is greater than the width of the narrowest part of the outer wall groove of the knob housing. The middle part of the slider is a waist column, one end of which is fixedly connected to the inner side wall of the push block. The outer diameter of the waist column is smaller than the width of the narrowest part of the outer wall groove of the knob shell, and it is movably locked at the narrowest part of the outer wall groove of the knob shell. The inner end of the slider is a stop block, one end of which is fixedly connected to the other end of the waist column. The outer diameter of the stop block is larger than the narrowest width of the groove on the outer wall of the knob shell. The other end of the stop block abuts against the rocker arm and can slide back and forth between the proximal and distal ends of the rocker arm.

37. The transapical mitral valve replacement delivery device as described in claim 36, characterized in that... The block has: A cylindrical segment, one end of which is fixedly connected to the other end of the waist column; A hemispherical segment extends integrally from the other end of the cylindrical segment, and the spherical surface of the hemispherical segment abuts against the seesaw.

38. The transapical mitral valve replacement delivery device as described in claim 36, characterized in that... The push block is waist-shaped, and several protrusions are distributed on the outer side wall of the push block to increase friction.

39. The transapical mitral valve replacement delivery device as described in claim 36, characterized in that... The knob housing is generally cylindrical and hollow inside, and has the following characteristics: The N outer wall grooves are waist-shaped, and the slider is slidably engaged in the outer wall grooves; N inner wall grooves are provided at positions corresponding to the outer wall grooves and are connected to the outer wall grooves. The seesaw rod is provided in the inner wall grooves.

40. The transapical mitral valve replacement delivery device as described in claim 39, characterized in that... The inner side of the outer wall groove is a small waist-shaped groove, located in the middle of the shell wall of the knob housing, and the waist column of the slider is slidably engaged in the small waist-shaped groove. The outer side of the outer wall groove is a large waist-shaped groove, which corresponds to and is connected to the small waist-shaped groove. The large waist-shaped groove accommodates the push block of the slider.

41. The transapical mitral valve replacement delivery device as described in claim 40, characterized in that... The inner wall groove has pivot holes on both sides, and the two ends of the rocker arm are respectively inserted into the pivot holes on both sides of the inner wall groove.

42. The transapical mitral valve replacement delivery device as described in claim 26, characterized in that... N is 2.

43. The transapical mitral valve replacement delivery device as described in claim 26, characterized in that... The inner cavity of the knob housing has a washer located at the middle of the rocker arm. The washer is sleeved on the outside of the push tube and is located between the proximal retaining ring of the push tube and the proximal retaining ring of the retraction tube.

44. The transapical mitral valve replacement delivery device as described in claim 26, characterized in that, The proximal end of the push tube is fixedly provided with an expansion ring with the same thickness as the retraction tube. The retaining ring of the push tube is fixed on the expansion ring. The expansion ring ensures that the inner and outer diameters of the retaining ring at the proximal end of the retraction tube are consistent with and aligned with the inner and outer diameters of the retaining ring at the proximal end of the push tube.

45. The transapical mitral valve replacement delivery device as described in claim 26, characterized in that... The distal end of the knob housing is provided with a tube channel that passes through the proximal ends of the push tube and the retraction tube. The near end of the knob housing is provided with a locking channel through which the far end of the locking head passes.

46. ​​The transapical mitral valve replacement delivery device as described in claim 1, characterized in that... The inner wall of the distal end of the conveying pipe is provided with an inner stepped opening; The proximal outer wall of the valve constrictor tube is provided with an outer stepped opening, which is matched and connected with the inner stepped opening to form an abutment.

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