CN115105258A

CN115105258A - Heart valve delivery system with circumferential limiting mechanism

Info

Publication number: CN115105258A
Application number: CN202210682164.1A
Authority: CN
Inventors: 吴明明; 戴志成; 耿肖肖; 葛云龙; 陈大凯
Original assignee: Koka Nantong Lifesciences Co Ltd
Current assignee: Koka Nantong Lifesciences Co Ltd
Priority date: 2022-06-02
Filing date: 2022-06-15
Publication date: 2022-09-27

Abstract

A precisely positioned and easily operated heart valve delivery system including a circumferential stop mechanism may include a catheter system for delivering an external heart valve to a target location, a release device for releasing the heart valve, and a positioning device for precisely positioning the heart valve. The positioning device can comprise a central positioning structure, a circumferential positioning structure and an axial positioning structure, and the proximal end of the circumferential positioning structure is connected with the distal end of the external thread sleeve of the axial positioning structure through a circumferential limiting mechanism. The heart valve delivery system with the circumferential limiting mechanism is accurate in positioning, easy to operate and free of damage to human tissues.

Description

Heart valve delivery system with circumferential limiting mechanism

Technical Field

The invention relates to the technical field of medical instruments, in particular to a heart valve conveying system with a circumferential limiting mechanism and a method for conveying a heart valve.

Background

Since the way of performing surgery via a catheter has many advantages such as less trauma and fast recovery, more and more surgeries are beginning to be performed via a catheter. Aortic valve replacement was also changed from the earlier surgical approach to transcatheter aortic valve replacement.

Replacement of the aortic valve is usually accomplished by means of a heart valve and a heart valve delivery system including a circumferential stop mechanism, and as heart valves are developed, higher requirements are put on the heart valve delivery system. In particular, the delivery system for a heart valve ensures both the accurate placement and angle of the heart valve into the aorta, providing a reasonable space for expansion of the heart valve, and ensures that no tissue is lost during delivery.

To this end, there is a continuing need in the art to develop heart valve delivery systems including circumferential stop mechanisms and methods of delivering heart valves that are accurate in positioning and easy to operate.

Disclosure of Invention

It is an object of the present application to provide a heart valve delivery system including a circumferential stop mechanism that is accurate in positioning and easy to operate. The heart valve delivery system including the circumferential stop mechanism described herein may include a catheter system for delivering an external heart valve to a target location, a release device for releasing the heart valve, and a positioning device for accurately positioning the heart valve. The positioning device can comprise a central positioning structure, a circumferential positioning structure and an axial positioning structure, and the proximal end of the circumferential positioning structure is connected with the distal end of the external thread sleeve of the axial positioning structure through a circumferential limiting mechanism. In particular, the circumferential stop mechanism may comprise a gear adjustment device and a gear wheel, which may be connected to the circumferential positioning structure or the axial positioning structure, or even may be formed as an integral structure with any of them. The gear is adjusted by a gear adjustment device such that the circumferential positioning structure may or may not rotate circumferentially relative to the axial positioning structure.

It is also an object of the present application to provide a method of delivering a heart valve using a heart valve delivery system comprising a circumferential adjustment mechanism as described above.

In order to achieve the above object, the present invention provides the following technical solutions.

In a first aspect, the present application provides a heart valve delivery system including a circumferential stop mechanism, comprising:

the catheter system is used for conveying an external heart valve to a target position and comprises an inner tube, a middle tube and an outer tube which are sequentially sleeved, wherein the proximal end of the heart valve is constructed to be clamped between the inner tube and the middle tube, and the distal end of the heart valve is constructed to be clamped between the middle tube and the outer tube;

a delivery device for delivering a heart valve, the delivery device comprising a proximal delivery structure and a distal delivery structure, the proximal delivery structure for controlling axial movement of the outer tube and the distal delivery structure for controlling axial movement of the inner tube;

the positioning device comprises a central positioning structure, a circumferential positioning structure and an axial positioning structure, wherein the central positioning structure enables a heart valve to move to the central axis of an aorta by adjusting the curvature of the distal end of the heart valve delivery system with the circumferential limiting mechanism, the circumferential positioning structure is fixedly connected with the catheter system and is constructed to drive the catheter system to rotate around the axis of the catheter system so as to enable a positioning piece of the heart valve to be axially aligned with the sinus floor, the axial positioning structure is used for adjusting the axial position of the heart valve, and comprises an external thread sleeve and a tubular guide piece, wherein the external thread sleeve is constructed to be capable of axially moving but not being capable of circumferentially moving relative to the tubular guide piece;

wherein the proximal end of the internally threaded sleeve and the distal end of the tubular guide are connected by a drive nut for controlling axial movement of the internally threaded sleeve relative to the tubular guide;

wherein, the nearly heart-end of circumference location structure with axial positioning structure's the telescopic heart-end of external screw thread passes through circumference stop gear and connects, circumference stop gear includes gear adjusting device and gear, the gear with circumference location structure perhaps axial positioning structure fixed connection, gear adjusting device with the gear cooperation is used for making circumference location structure can or can not for axial positioning structure carries out the rotation in a circumferential direction.

In one embodiment of the first aspect, the gear adjustment device comprises:

the two ends of the fixed frame are opened, a movement space is provided for the gear adjusting device, and one side of the fixed frame, facing the positioning device, is arc-shaped and is matched with the shape of an outer shell of the positioning device;

the axial adjustment assembly faces and is constructed to partially penetrate through the fixed frame and move axially relative to the fixed frame, the axial adjustment assembly faces and comprises a gear locking portion used for limiting circumferential rotation of the gear, and when the gear locking portion is clamped with the gear, the gear cannot rotate circumferentially.

In one embodiment of the first aspect, the axial adjustment assembly comprises:

the side, facing the gear, of the gear locking part comprises locking teeth protruding outwards, and the locking teeth can be clamped with the teeth of the gear;

the external thread rod is used for controlling the locking tooth to be clamped or separated from the gear;

the internal thread pipe, the internal thread pipe sets up keeping away from of fixed frame one side of gear, be used for with the cooperation of external screw thread pole is adjusted the axial adjustment subassembly with axial distance between the gear.

In one embodiment of the first aspect, the other side of the gear lock is provided with a hollow accommodating cavity, and one side of the external threaded rod facing the gear is provided with a connecting block, and the connecting block is located in the hollow accommodating cavity to connect the external threaded rod and the gear lock.

In an implementation manner of the first aspect, the open end of the hollow accommodating cavity is further provided with a clamping block, and the clamping block limits the connecting block in the hollow accommodating cavity.

In an implementation manner of the first aspect, a condensation rod is further arranged between the external threaded rod and the connecting block, and the clamping block limits the condensation rod in the hollow accommodating cavity;

a first clamping block groove matched with the wall of the hollow accommodating cavity is formed in one side, close to the hollow accommodating cavity, of the clamping block, and a second clamping block groove matched with the condensation rod is formed in one side, close to the condensation rod, of the clamping block;

the diameter of an opening of the second clamping groove is larger than that of the condensation rod, but smaller than that of the connecting block and the external thread rod.

In an embodiment of the first aspect, a gap exists between a side wall of the first clamping block groove close to the condensation rod and an end face of the connecting block on a side far away from the gear, so as to avoid driving the gear lock to rotate when the external threaded rod rotates.

In an embodiment of the first aspect, a cross section of the groove of the second clamping block is semicircular, and the condensation rod is limited in the hollow accommodating cavity by the two clamping blocks.

In one embodiment of the first aspect, an end of the externally threaded rod remote from the gear is provided with a knob.

In one embodiment of the first aspect, one end of the male threaded rod, which is far away from the gear, is provided with a male threaded rod clamping groove and a male threaded rod threaded hole which are recessed towards the male threaded rod;

one side of the knob, which faces the external threaded rod, comprises a knob threaded rod and a knob clamping piece arranged on the periphery of the knob threaded rod;

the external thread rod clamping groove is matched with the knob clamping piece, and the external thread rod threaded hole is matched with the knob threaded rod and used for connecting the knob to the external thread rod.

In one embodiment of the first aspect, the circumferential positioning structure comprises:

a tubular housing comprising a housing outer surface, a housing inner surface, and a housing wall extending between the tubular housing outer surface and the tubular housing inner surface, wherein at least a portion of the conduit system passes through a hollow interior of the tubular housing;

an anti-center tube rotation tube having one end in fluid communication with the interior space of the first stepped sealing sleeve and the other end abutting against the tubular housing and extending through the inner surface of the tubular housing, the anti-center tube rotation tube simultaneously serving as an evacuation tube for the center tube for evacuating air between the center tube and the inner tube;

an outer tube rotation prevention tube having one end in fluid-tight communication with the inner space of the second stepped seal sleeve and the other end abutting against the tubular housing and extending through the inner surface of the tubular housing, the outer tube rotation prevention tube simultaneously serving as an evacuation tube of the outer tube for evacuating air between the outer tube and the middle tube;

wherein the inner space of the first stepped sealing sleeve, the outer surface of the inner tube and the inner surface of the middle tube form a first cavity having an opening at the proximal end of the middle tube, the inner space of the second stepped sealing sleeve, the outer surface of the middle tube and the inner surface of the outer tube form a second cavity having an opening at the proximal end of the outer tube, and the first and second stepped sealing sleeves are disposed inside the tubular housing in a direction from the distal end to the proximal end;

wherein the tubular housing is configured such that when the tubular housing is rotated circumferentially, the catheter system is rotated circumferentially in synchronization with the tubular housing.

In one embodiment of the first aspect, the first stepped sealing sleeve comprises a first sleeve and a second sleeve fixedly connected, the first sleeve being closer to the distal end of the tubular housing than the second sleeve, and the distal end of the first sleeve comprising a sealing structure;

the diameter of the second sleeve is smaller than that of the first sleeve, and the far end of the middle pipe is fixedly connected to the hollow inner space of the second sleeve.

In one embodiment of the first aspect, the second stepped seal sleeve comprises fixedly connected third, fourth and fifth sleeves, the fourth sleeve being closer to the distal end of the tubular housing than the third sleeve, the fifth sleeve being closer to the distal end of the tubular housing than the fourth sleeve, and the distal end of the third sleeve comprising a seal structure;

the diameter of the fourth sleeve is smaller than that of the third sleeve, the diameter of the fifth sleeve is smaller than that of the fourth sleeve, and the far end of the outer tube is fixedly connected to the hollow inner space of the fifth sleeve.

In one embodiment of the first aspect, the distal release structure of the release device includes a release plate and a drive ring, the release plate is butterfly-shaped, and both ends of the release plate extend through the tubular housing and are centrally clamped with the drive ring and are driven by the drive ring to move axially;

the driving ring is arranged on the periphery of the connecting part of the cylindrical outer pipe and used for driving the tubular shell to move along the axial direction of the tubular shell.

In an embodiment of the first aspect, the release device is further provided with a radial stop structure comprising a number of guide plates arranged axially parallel to the tubular housing such that the drive ring is not movable in a radial direction.

In one embodiment of the first aspect, the tubular housing includes a release plate anti-misoperation structure including a transverse through hole and a longitudinal through hole provided on the tubular housing in communication with each other, the transverse through hole extending a first distance in the axial direction of the rotating shaft, the longitudinal through hole extending a second distance in the axial direction of the rotating shaft, the first distance configured to limit axial movement of the release plate along the rotating shaft, the second distance configured to accommodate axial movement of the release plate along the rotating shaft, and the first distance being smaller than the second distance.

In one embodiment of the first aspect, the proximal delivery structure of the delivery device comprises a hollow central shaft and a plurality of delivery discs spaced about the hollow central shaft, the central shaft comprising a first hollow passage and a second hollow passage adapted for passage of a guidewire therethrough, the first hollow passage having a diameter less than the diameter of the second hollow passage, the first hollow passage being closer to the distal end of the delivery device than the second hollow passage, and the inner tube being fixedly attached within the second hollow passage.

In one embodiment of the first aspect, the proximal end of the proximal release structure is nested within the distal end of the tubular housing, and the maximum radial dimension of the proximal end of the proximal release structure is greater than the maximum dimension of the distal opening of the tubular housing for limiting the maximum distance the proximal release structure can be moved axially in the distal direction.

In one embodiment of the first aspect, a removable catch is provided between the proximal hub of the proximal release structure and the distal end of the tubular housing to limit movement of the proximal release structure in the axial direction.

In one embodiment of the first aspect, the distal end of the inner tube is provided with an eversion structure forming a circular ring, the distal end of the middle tube is provided with a first flaring structure, and the proximal end of the heart valve is clamped between the circular ring and the flaring structure.

In an embodiment of the first aspect, the distal end of the outer tube is provided with a second external expanding structure, the joint of the middle tube and the second external expanding structure comprises a fixing ring, and the proximal end of the heart valve is clamped between the second external expanding structure and the fixing ring to limit the radial movement of the heart valve.

Compared with the prior art, the beneficial effect of this application lies in:

(1) the heart valve conveying system with the circumferential limiting mechanism is accurate in positioning and easy to control;

(2) the tubular shell is provided with a release plate anti-misoperation structure, and the axial movement of the release plate is limited under the condition that the release plate does not need to move;

(3) the far end of the middle pipe comprises a heart valve fixing ring for clamping the heart valve in the fixing ring, so that the heart valve can be prevented from losing vascular tissues;

(4) when the heart valve conveying system containing the circumferential limiting mechanism is used for conveying the heart valve, the proximal end (inflow end) of the heart valve is clamped with the middle pipe through the inner pipe, the distal end (outflow end) of the heart valve is clamped with the outer pipe through the middle pipe, when the heart valve is released, the proximal end of the heart valve is released by pushing the inner pipe to the left, and the distal end of the heart valve is released by retreating the outer pipe, so that damage to the valve or the relocation of the positioned valve can be avoided in the process that competitive products are all pushed to the left (left ventricle side).

Drawings

The technical features and advantages of the present invention are more fully understood by reference to the following detailed description in conjunction with the accompanying drawings, in which:

FIG. 1 is a schematic view of a heart valve delivery system including a circumferential stop mechanism according to one embodiment of the present application;

FIG. 2 is an enlarged view of a portion of FIG. 1 at G;

FIG. 3 is a front view of a heart valve delivery system including a circumferential stop mechanism according to one embodiment of the present application;

FIG. 4 is a schematic view of a heart valve delivery system including a circumferential stop mechanism according to one embodiment of the present application;

FIG. 5 is an exploded view of a heart valve delivery system including a circumferential stop mechanism according to one embodiment of the present application;

fig. 6A is a schematic view of a gear adjusting device according to an embodiment of the present application, fig. 6B is a schematic view of a snap-in block of the gear adjusting device according to an embodiment of the present application, and fig. 6C is a schematic view of a hollow accommodating chamber of the gear adjusting device according to an embodiment of the present application;

FIG. 7A is an exploded view of a gear adjustment device according to an embodiment of the present application, FIG. 7B is a schematic view of an axial adjustment assembly, FIG. 7C is a schematic view of a knob, and FIG. 7D is a schematic view of an end of an externally threaded rod;

FIG. 8 is a top view of a heart valve delivery system including a circumferential stop mechanism according to one embodiment of the present application;

FIG. 9A is a cross-sectional view taken along section A-A of FIG. 8;

FIG. 9B is a schematic view of a release tip configuration of the heart valve delivery system of FIG. 8 incorporating a circumferential adjustment mechanism;

FIG. 10A is a schematic view of a seal within a tubular housing according to an embodiment of the present application, and FIG. 10B is a schematic view of an outer tube seal according to an embodiment of the present application;

FIG. 11 is a front view of a tubular housing according to one embodiment of the present application;

FIG. 12 is a proximal end schematic view of an externally threaded sleeve according to one embodiment of the present application;

FIG. 13 shows an exploded view of a tubular guide according to an embodiment of the present application;

FIG. 14 shows an exploded view of a tubular guide and a tapered guide structure according to an embodiment of the present application;

FIG. 15 shows an exploded view of another angle of a tubular guide and a tapered guide structure according to an embodiment of the present application;

FIG. 16 shows a schematic view of a tapered guide structure according to an embodiment of the present application;

FIG. 17 shows a schematic view of the internal structure of a heart valve delivery system including a circumferential stop mechanism according to another embodiment of the present application;

FIG. 18 is a partial enlarged view of the portion B in FIG. 17

FIG. 19 shows a schematic view of the distal end of FIG. 17;

FIG. 20 shows a schematic structural view of a threaded pipe according to an embodiment of the present application;

fig. 21 shows a schematic view of a heart valve according to an embodiment.

Detailed Description

Unless otherwise defined, technical or scientific terms used in the present specification and claims should have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

In the description of the present invention, it is to be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", and the like, indicate orientations or positional relationships based on those shown in the drawings, and are used only for convenience in describing the present invention and for simplicity in description, and do not indicate or imply that the referenced devices or elements must have a particular orientation, be constructed and operated in a particular orientation, and thus, are not to be construed as limiting the present invention.

Furthermore, the terms "first", "second", etc. are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first," "second," etc. may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless otherwise specified.

In the description of the present invention, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art through specific situations.

As used herein, when describing a heart valve, a release tip, a tubular housing, an internally threaded sleeve, a tubular housing, a tubular guide, a bend-adjusting structure, a guidewire, and a catheter system, etc., the "proximal end" refers to the side of the catheter system or the side in the direction of the user-manipulated end when the heart valve assumes an expanded state. Correspondingly, "distal end" refers to the side of the heart valve that is remote from the catheter system or away from the direction of the user-manipulated end when the heart valve assumes the expanded state. In the present application, when describing the heart valve, "proximal" refers to the side of the heart valve that is closer to the apex of the heart when the heart valve is in an expanded state. Accordingly, "distal" refers to the side of the heart valve that is distal from the apex of the heart when the heart valve is in an expanded state. Because the heart valves described herein are delivered transcatheter to the aorta, the distal and proximal ends are at the same location and the proximal and distal ends are at the same location.

Example 1

The present embodiment provides a heart valve delivery system 100 including a circumferential stop mechanism.

Referring first to fig. 1-5, a heart valve delivery system 100 including a circumferential stop mechanism of the present embodiment may include, in order, a delivery tip 1, a tubular housing 2, an externally threaded sleeve 3, a tubular guide 4, and a tapered guide structure 10, in a direction from the distal end to the proximal end. The proximal end of the delivery tip 1 may fit within the distal opening of the tubular housing 2. The proximal end of the tubular housing 2 and the distal end of the externally threaded sleeve 3 may be connected by a circumferential stop mechanism 11. The proximal end of the externally threaded sleeve 3 and the distal end of the tubular guide 4 may be connected by a drive nut 8. The proximal end of the tubular guide 4 may be connected to the distal end of the conical guide structure 10 by a coupling nut 9. The heart valve delivery system 100 with the circumferential limiting mechanism can further comprise a bending adjusting device 5, wherein the proximal end of the bending adjusting device 5 is fixedly connected with the tubular guide 4.

In addition, the heart valve delivery system 100 including the circumferential stop mechanism may also include a catheter system. The catheter system may be used to deliver an external heart valve to a target site. The catheter system comprises an inner tube, a middle tube and an outer tube which are sequentially sleeved, wherein the proximal end of the heart valve is constructed into a shape capable of being clamped between the inner tube and the middle tube, and the distal end of the heart valve is constructed into a shape capable of being clamped between the middle tube and the outer tube. The inner, middle and outer tubes of the catheter system all extend a predetermined distance through the proximal end of the tapered guide structure 10.

In one embodiment, the heart valve delivery system 100 including the circumferential stop mechanism includes a release device for releasing the heart valve. The releasing device comprises a proximal releasing structure and a distal releasing structure, the proximal releasing structure is used for controlling the axial movement of the outer tube, and the distal releasing structure is used for controlling the axial movement of the inner tube. In this embodiment, the proximal release structure may be a release tip 1 for releasing the proximal end of the heart valve. Furthermore, the distal release structure may comprise a release plate 7 arranged inside the tubular housing 2 and protruding from the outside of the tubular housing 2 for releasing the distal end of the heart valve.

In one embodiment, a heart valve delivery system including a circumferential stop mechanism can include a positioning device for precisely positioning a heart valve. The positioning device comprises a central positioning structure, a circumferential positioning structure and an axial positioning structure, wherein the circumferential positioning structure is fixedly connected with the catheter system and is constructed to drive the catheter system to rotate around the axis of the catheter system so as to enable the positioning piece of the heart valve to be axially aligned to the sinus floor, the axial positioning structure is used for adjusting the axial position of the heart valve and comprises an external thread sleeve and a tubular guide piece, and the external thread sleeve is constructed to be capable of axially moving relative to the tubular guide piece but not capable of circumferentially moving. In this embodiment, the centering structure may comprise a bending adjustment device 5 for moving the heart valve onto the central axis of the aorta by adjusting the bending of the distal end of the heart valve delivery system comprising the circumferential stop mechanism. In this embodiment, the circumferential positioning structure may include a tubular housing 2, an anti-middle tube rotation tube 213 and an anti-outer tube rotation tube 215 disposed within the tubular housing. The tubular housing 2 is configured to bring the catheter system into circumferential rotation in synchronism with the tubular housing 2 when the tubular housing 2 is subjected to circumferential rotation. In this embodiment, the axial positioning structure may comprise an externally threaded sleeve 3 and a tubular guide 4, the connection between the externally threaded sleeve 3 and the tubular guide 4 being via a drive nut 8. By rotating the drive nut 8, the externally threaded sleeve 3 can be moved axially relative to the tubular guide 4.

The improvement of the present application compared to the prior art is firstly the way in which the tubular housing 2 and the externally threaded sleeve 3 are connected. In one embodiment, the proximal end of the tubular housing 2 of the circumferential positioning structure and the distal end of the externally threaded sleeve 3 of the axial positioning structure are connected by a circumferential limiting mechanism 11, the circumferential limiting mechanism 11 comprises a gear adjusting device 111 and a gear 112, the gear 112 is fixedly connected with the circumferential positioning structure or the axial positioning structure, and the gear adjusting device 111 cooperates with the gear 112 for enabling or disabling the circumferential positioning structure to rotate circumferentially relative to the axial positioning structure. In one embodiment, the gear 112 may even be formed as a unitary structure with either the circumferentially oriented structure or the axially oriented structure. The gear wheel 11 is adjusted by means of a gear wheel adjustment device 111 such that the circumferential positioning structure can or cannot be rotated circumferentially relative to the axial positioning structure. In other words, the circumferential locating feature is circumferentially rotatable relative to the axial locating feature when the gear adjustment device 111 and the gear 112 are in the first position and is not circumferentially rotatable relative to the axial locating feature when the gear adjustment device 111 and the gear 112 are in the second position. By operating the gear adjustment device 111, the relative positions of the gear adjustment device 111 and the gear 112 can be switched between the first position and the second position.

Referring to fig. 6-7, in one embodiment, the gear adjustment device 111 may include a fixed frame 1101 and an axial adjustment assembly. The fixing frame 1101 may be opened at both ends to provide a movement space for the gear adjusting device 111. The fixing frame 1101 may be fixedly connected to a circumferential positioning structure or an axial positioning structure of the positioning device. The side of the fixing frame 1101 facing the positioning device is arc-shaped to match the shape of the outer housing of the positioning device, so that the gear adjustment device 111 can be snugly fixed on the surface of the positioning device. In this embodiment, the axial adjustment assembly is configured to pass through the fixed frame 1101 and move axially relative to the fixed frame 1101. One end of the axial adjusting component facing the gear 112 comprises a gear locking portion 1103 for limiting circumferential rotation of the gear, and when the gear locking portion 1103 is clamped with the gear 112, the gear 112 cannot rotate circumferentially.

In a preferred embodiment, the axial adjustment assembly may include a geared lock 1103, an externally threaded rod 1105, and an internally threaded tube 1106. One side of the gear lock 1103 facing the gear 112 comprises locking teeth 1107 protruding outwards, the locking teeth 1107 are adapted to be engaged with teeth of the gear 112, and the other side of the gear lock 1103 is provided with a hollow accommodating cavity 1108. In one embodiment, the gear lock 1103 may include a plurality of lock teeth 1107 having a trapezoidal cross section with a smaller cross sectional length near the end of the gear 112 than at the end remote from the gear 112. In addition, the profile of the groove formed between adjacent locking teeth 1107 can match the tooth profile of the gear 112, thereby achieving both the limiting of the gear 112 and the damage to the teeth of the gear 112.

In one embodiment, an internally threaded tube 1106 is provided on the side of the fixed frame 1101 remote from the gear 112 for cooperating with an externally threaded rod 1105 for adjusting the axial distance between the axial adjustment assembly and the gear 112. In one embodiment, a male threaded rod 1105 is used to control the engagement or disengagement of the locking teeth with the gear. A connecting block 1109 is arranged on one side of the external threaded rod 1105 facing the gear 112, and the connecting block 1109 is located in the hollow accommodating cavity 1108 to connect the external threaded rod 1105 with the gear locking portion 1103. The open end of the hollow accommodating cavity 1108 is also provided with a clamping block 1112, and the clamping block 1112 limits the connecting block 1109 in the hollow accommodating cavity 1108. A condensation rod 1110 is further arranged between the external thread rod 1105 and the connecting block 1109, and the clamping block 1112 limits the condensation rod 1110 in the hollow accommodating cavity 1108. One side that the joint piece 1112 is close to the cavity holds the chamber 1108 is provided with the cavity holds the first joint piece recess 1113 of the wall complex of chamber 1108, just one side that the joint piece 1112 is close to the condensation pole 11110 is provided with the second joint piece recess 1114 of condensation pole complex. In this embodiment, the opening diameter of the second snap groove 1114 is larger than the diameter of the condensation bar 1110, but smaller than the diameter of the connection block 1109 and the externally threaded bar 1105, thereby trapping the condensation bar 1110 within the hollow receiving chamber 1108.

In one embodiment, a gap exists between the side wall 11131 of the first clamping block groove 1113 close to the male screw rod 1105 and the end surface of the connecting block 1109 far from the gear, so as to avoid driving the gear lock to rotate when the male screw rod 1105 rotates.

In a specific embodiment, the cross section of the second clamping block groove 1114 is semicircular, and the condensation rod 1110 of the external thread rod 1105 is clamped with the hollow accommodating cavity 1108 through two clamping blocks 1112. The two clamping blocks 1112 can have a symmetrical structural shape. Those skilled in the art will appreciate that the snap blocks 1112 and the hollow receiving cavity 8 may further include corresponding mounting through holes for ease of positioning and mounting.

In this embodiment, the rotation of the male screw 1105 with respect to the female screw 1106 causes the male screw 1105 to move in the axial direction, and the gear-locked portion 1103 provided at the end of the male screw 1105 is moved together. When the gear lock portion 1103 is engaged with the teeth of the gear 112, the gear 112 cannot rotate. When the gear lock 1103 is completely out of contact with the teeth of the gear 112, the gear 112 may rotate freely. Because the gear 112 is fixedly connected to either the circumferentially-oriented structure or the axially-oriented structure, the circumferentially-oriented structure and the axially-oriented structure can now rotate relative to each other.

In another embodiment, in order to reduce the difficulty of rotating the externally threaded rod 1105, a knob 1121 may be provided at an end of the externally threaded rod 1105 away from the gear 112. In a preferred embodiment, in order to ensure a tight connection between the male screw bar 1105 and the knob 1121, a male screw bar catching groove 1115 and a male screw bar threaded hole 1116 recessed toward the male screw bar 1105 may be provided at an end of the male screw bar 1105 remote from the gear 112. Accordingly, a side of the knob facing the male screw rod includes a knob threaded rod 1122 and a knob engaging piece 1123 provided on an outer periphery of the knob threaded rod 1122. In this embodiment, the male screw bar groove 1115 is engaged with the knob engagement 1123, and the male screw bar threaded hole 1116 is engaged with the knob threaded rod 1122, so that the knob 1121 is connected to the male screw bar 1105 of the male screw bar 1105.

The various portions of the heart valve delivery system 100 including the circumferential stop mechanism and their positional relationships are described in more detail below in conjunction with the drawings.

Next, the structure of the release tip 1 and the positional relationship between the release tip 1 and the tubular housing 2 will be described.

The release tip 1 is intended to release the proximal end of the heart valve by pushing the inner tube forward. In one embodiment, referring to fig. 8 and 9, the release tip 1 comprises a hollow central shaft 101 comprising a first hollow channel 103 and a second hollow channel 104 adapted for the passage of a guide wire and a plurality of release discs 102 spaced over the hollow central shaft. The first hollow passage 103 has a diameter less than the diameter of the second hollow passage 104, the first hollow passage 103 being closer to the distal end of the delivery device than the second hollow passage 104. The inner tube is fixedly connected within the second hollow passage 104. In one embodiment, the diameter of the first hollow channel 103 is smaller than the diameter of the second hollow channel 104 because the diameter of the guidewire is smaller than the diameter of the inner tube. In one embodiment, the inner tube can be snapped into the second hollow channel 104 and then passed through the tubular housing 2, the externally threaded sleeve 3, and the tubular guide 4 in that order and extended proximally of the heart valve delivery system including the circumferential stop mechanism. In one embodiment, the diameter of the plurality of release discs 102 may decrease and then increase in a direction from distal to proximal, thereby increasing friction and facilitating grasping.

The distal end of the release tip 1 may be connected to the proximal end of the tubular housing 2. In one embodiment, the proximal end of the delivery tip 1 is nested within the distal end of the tubular housing 2, and the maximum radial dimension of the proximal end of the delivery tip 1 is greater than the maximum dimension of the distal opening of the tubular housing to limit the maximum distance that the delivery tip 1 can be axially displaced in the distal direction. This arrangement prevents the release tip 1 from falling out of the tubular housing 2.

In another embodiment, a snap-fit 6 is provided between the release tip 1 and the tubular housing 2 for filling the gap between the release tip 1 and the tubular housing 2 and preventing the release tip 1 from pushing the inner tube in the proximal direction. When the proximal end of the heart valve needs to be released, the clamping piece 6 is pulled out, the release tail end 1 is pushed towards the proximal end, and the inner tube moves towards the proximal end. When the inner tube is separated from the middle tube, the proximal end of the heart valve can be expanded.

Next, the structure of the tubular housing 2 and the positional relationship between the tubular housing 2 and the externally threaded sleeve 3 will be described.

In one embodiment, referring to fig. 4-5 and 8-11, the circumferential positioning structure of the heart valve delivery system 100 including the circumferential stop mechanism can include a tubular housing 2, an anti-middle tube rotation tube 213, and an anti-outer tube rotation tube 215. The tubular housing 2 may comprise a housing outer surface 21, a housing inner surface 22 and a housing wall 23 extending between the tubular housing outer surface 21 and the tubular housing inner surface 22. At least a portion of the conduit system passes through the hollow interior of the tubular housing 2. The anti-middle tube rotation tube 213 is in fluid communication with the interior space of the first stepped sealing sleeve 25 at one end and abuts the tubular housing 2 at the other end and extends through the tubular housing inner surface 22. The middle pipe rotation preventing pipe 213 serves also as an emptying pipe of the middle pipe for discharging air between the middle pipe and the inner pipe. The outer tube rotation prevention tube 215 is in fluid tight communication with the inner space of the second stepped sealing sleeve 26 at one end and abuts the tubular housing 2 at the other end and extends through the inner surface 22 of the tubular housing. The outer-pipe rotation preventing pipe 215 also serves as an evacuation pipe for the outer pipe for evacuating air between the outer pipe and the middle pipe. The inner space of the first stepped sealing sleeve 25, the outer surface of the inner tube and the inner surface of the middle tube form a first cavity with an opening at the proximal end of the middle tube. The air between the middle tube and the inner tube can be evacuated by injecting physiological saline into the first cavity. Similarly, the interior space of the second stepped seal sleeve 26, the outer surface of the middle tube and the inner surface of the outer tube form a second cavity having an opening at the proximal end of the outer tube. The air between the outer tube and the middle tube can be evacuated by injecting saline into the second lumen. In one embodiment, the first stepped sealing sleeve 25 and said second stepped sealing sleeve 26 are arranged inside the tubular housing 2 in a direction from the distal end to the proximal end.

In one embodiment, the first stepped sealing sleeve 25 comprises a first sleeve 251 and a second sleeve 252 fixedly connected, the first sleeve 251 being closer to the distal end of the tubular housing 2 than the second sleeve 252. In one embodiment, the diameter of the second sleeve 252 is smaller than the diameter of the first sleeve 251, and the distal end of the middle tube is fixedly attached to the hollow interior of the second sleeve 252. For example, the distal end of the middle tube can be snapped into the hollow interior of the second sleeve. In one embodiment, the distal end of the first sleeve 251 includes a sealing structure.

In one embodiment, the second stepped seal sleeve comprises a third sleeve 261, a fourth sleeve 262 and a fifth sleeve 263 fixedly connected, the fourth sleeve 262 being closer to the distal end of the tubular housing than the third sleeve 261, the fifth sleeve 263 being closer to the distal end of the tubular housing 2 than the fourth sleeve 262. The diameter of the fourth sleeve 262 is smaller than that of the third sleeve 261, the diameter of the fifth sleeve 263 is smaller than that of the fourth sleeve 262, and the distal end of the outer tube is fixedly connected to the hollow inner space of the fifth sleeve 263. For example, the distal end of the outer tube can snap into the hollow interior of the fifth sleeve. In one embodiment, the distal end of the third sleeve 261 includes a sealing structure.

In this embodiment, the middle tube is fixedly connected to the inner space of the second sleeve 252, and the middle tube rotation preventing tube 213 has one end fixedly connected to the first sleeve 251 and the other end caught in the housing wall of the tubular housing 2. The middle tube will thus rotate circumferentially in synchronism with the tubular housing 2. Similarly, the outer tube is fixedly connected to the inner space of the fifth sleeve 263, and the outer-tube rotation preventing tube 215 has one end fixedly connected to the third sleeve 261 and the other end caught in the housing wall of the tubular housing 2. Thus, the outer tube will rotate circumferentially in synchronism with the tubular housing 2.

In one embodiment, the sealing structure at the distal end of the first sleeve 251 is similar to the sealing structure at the distal end of the third sleeve 261. The seal arrangement of the distal end of the third sleeve 261 will now be described with reference to fig. 8-11. In summary, the sealing gasket is pressed therein to seal by means of two snap-on sleeves, wherein a stepped bore is provided in the outer sleeve. The middle part of the sealing gasket is provided with a through hole. The structure is thick at the edge and thin at the middle part, and simultaneously, the sealing performance and the easy penetration performance are satisfied.

Referring to fig. 8-11, the distal end of the first sleeve 251 may include circumferentially spaced first snap holes 253 and first stepped holes 254 disposed therein. The proximal end of the first sealing sleeve 255 includes a first sealing boss 256 that is engageable with the first snap-fit aperture 253. When the proximal end of the first sealing sleeve 255 is sleeved inside the distal end of the first sleeve 251, the first sealing protrusion 256 is clamped into the first clamping hole 253, and the first sealing gasket 257 is pressed into the stepped hole 254 of the first sleeve 251, so that the inner tube is sealed.

Similarly, referring to fig. 9-11, the distal end of the third sleeve 261 can include circumferentially spaced second snap-in holes 264 and a second stepped hole 265 disposed therein. The proximal end of the second seal sleeve 266 includes a second seal bead 267 that is engageable with the second snap-in hole 264. When the proximal end of the second sealing sleeve 266 is sleeved inside the distal end of the third sleeve 261, the second sealing protrusion 267 is clamped into the second clamping hole 265, and the second sealing gasket 268 is pressed into the second stepped hole 265 of the third sleeve 261, so as to seal the outer tube.

In a preferred embodiment, the first and second stepped

bores

254, 265 are provided with chamfers to cooperate with the thicker outer periphery of the gasket to enhance the sealing effect.

In one embodiment, referring to fig. 4-5 and 8-9, the interior of the tubular housing 2 is further provided with the distal end relief structure of the relief device, which includes the relief plate 7, the radial stop structure and the drive ring 205. The release plate 7 may have a butterfly-like configuration, with both ends of the release plate 7 extending through the tubular housing 2, and the ends thereof may include spaced apart raised structures 210 for non-slip purposes. The release plate 7 is clamped centrally to the drive ring 205 and extends at both ends through the tubular housing 2. The release plate 7 is moved axially by the drive ring 205. In one embodiment, the radial stop structure includes a plurality of guide plates 212 arranged axially parallel to the tubular housing such that the drive ring 205 can only rotate or move in the axial direction of the tubular housing, but not in the radial direction. In one embodiment, the radial stop structure may include three guide plates 212 arranged in an arc at their ends, which arc may match the outer profile of the drive ring 205. In one embodiment, the driving ring 205 is disposed around the outer circumference of the cylindrical outer tube connecting portion for driving the tubular housing to move along the axial direction of the tubular housing. In one embodiment, the drive ring is disposed proximate the proximal end of the fourth sleeve 262. In one embodiment, the release plate 7 is not in direct axial contact with the drive ring 205 and is free to rotate circumferentially, preventing the distal valve from rotating when the release plate is rotated.

In one embodiment, referring to fig. 11, the tubular housing 2 may include a release plate anti-misoperation structure, which includes a transverse through hole 221 and a longitudinal through hole 222 communicating with each other, wherein the longitudinal through hole 222 is a rectangular structure and has a width slightly larger than the thickness of the release plate 7, such as the width of the longitudinal through hole 222: the thickness of the release plate 7 is 1.1-1.3, and the release plate 7 can move along the length direction of the longitudinal through hole 222 and plays a role of guiding the release plate 7. The transverse through hole extends a first distance in an axial direction of the rotary shaft, the longitudinal through hole extends a second distance in the axial direction of the rotary shaft, the first distance is configured to limit axial movement of the release plate along the rotary shaft, the second distance is configured to accommodate axial movement of the release plate along the rotary shaft, and the first distance is smaller than the second distance. In one embodiment, the tubular housing 2 may further comprise a raised point 217, the raised point 217 being disposed in the transverse through hole 221 for limiting free movement of the release plate. To avoid the release plate 7 being mishandled during the operation, a stepped hole is provided in the tubular housing. When release is not required, the release plate is located at the lower portion of the stepped bore, i.e., in the transverse through bore 221, and is restrained from axial movement.

In another embodiment, the proximal end of the tubular housing 2 may further comprise a gear receiving cavity 290, the hollow interior space of the gear receiving cavity 290 may be used for receiving the gear 112, and the outer housing thereof may be used for mounting the fixing frame 1101.

Next, the structure of the tubular guide 4 will be described.

The externally threaded sleeve 3 can be connected to the tubular guide 4 by means of a drive nut 8, which together form an axial positioning structure for adjusting the axial position of the heart valve.

Referring to fig. 12, the outer circumference of the proximal end of the externally threaded sleeve 3 may comprise an external thread 302 for cooperation with the drive nut 8. At this time, the distal end of the externally threaded sleeve 3 may further include a row of guide grooves 304 recessed toward the inside of the externally threaded sleeve 3 and perpendicular to the threads, and the guide grooves 304 may be engaged with a guide plate 490 provided inside the distal end of the tubular guide 4. Therefore, when the nut 8 is rotationally driven, the male screw 3 can be axially moved with respect to the tubular guide 4, but the male screw 3 does not rotate with respect to the tubular guide 4. The externally threaded sleeve 3 further comprises an externally threaded sleeve hollow channel 305 for receiving a guide wire and a catheter.

Referring to fig. 13-16, to facilitate assembly, the drive nut 8 may be used in conjunction with a snap ring 81 and a connector ring 82. The drive nut 8 may include a drive nut fitting hole 801 provided on a proximal end face of the drive nut 8 and a drive nut stepped hole 802 recessed by a predetermined distance from the proximal end face of the drive nut 8 toward the distal end of the drive nut 8. Accordingly, the snap ring 81 includes a snap ring fitting hole 811 provided on a distal end surface of the snap ring 81 and a snap ring stepped hole 812 recessed from the distal end surface of the snap ring 81 toward a proximal end of the snap ring by a predetermined distance. The drive nut fitting hole 801 and the snap ring fitting hole 811 correspond to each other for fixing the drive nut 8 and the snap ring 81. The attachment ring 82 may then be disposed at the distal end of the tubular guide 4 and adapted to be received within the cavity formed by the drive nut stepped bore 802 and the snap ring stepped bore 812.

The proximal end of the tubular guide 4 may be connected to a conical guide structure 10 by a coupling nut 9. Referring to fig. 14, the proximal end of the tubular guide 4 may be provided with an external thread 405 that mates with the internal thread of the coupling nut 9. Furthermore, an annular connecting disk 406 can be arranged between the proximal end of the tubular guide 4 and the distal end of the conical guide 10, and a first snap ring 407 and a second snap ring 408 can be arranged on the side of the annular connecting disk facing 406 toward the conical guide 10, wherein the second snap ring 408 has a larger diameter than the first snap ring 407. With such a structure, the contact part of the annular connecting disc 406 and the conical guide structure 10 is gradually shortened from the middle part along the radial direction, and the structure is more stable. The annular connecting disc also comprises a connecting rivet 409 and a pull wire hole 410 suitable for a pull wire to pass through. In one embodiment, as shown in FIG. 20, the tapered guide structure 10 further includes a pull wire channel 1006 adapted for passage of a pull wire therethrough. Referring to fig. 21, the pull wire passage 1006 is at an angle α of no greater than 30 ° to the central axis of the conical guide structure 10 (not shown). The tapered guide structure 10 may include an access tube 1001 and a tapered housing 1002. The dip tube may extend through a central opening of the annular land and the end of the dip tube may include a recessed land 1003 recessed towards the proximal end of the dip tube for mating with a seal ring. Further, referring to fig. 16, at least three stepped baffles 1004 may be disposed within the conical housing and about the periphery of the dip tube, the stepped baffles 1004 extending axially of the dip tube, and the end of each baffle facing the distal end of the dip tube including a first recess 1007 and a second recess 1008 recessed toward the proximal end of the dip tube. The first recess 1007 is closer to the extension tube for mating with the first snap ring 407. The second groove 1008 is closer to the tapered housing 10002 for mating with the second snap ring 408 to achieve a double seal. The distal end of the tapered guide structure 10 may also include a mounting hole 1005 for mating with a connection rivet 409.

Next, the structure of the bend adjusting device 5 and the positional relationship between the bend adjusting device 5 and the tubular guide 4 will be briefly described.

Referring to fig. 17, the heart valve delivery system 100 including the circumferential stop mechanism may further include a bend adjustment device 5, the bend adjustment device 5 including a bend adjustment device hollow channel adapted to receive an adjustable bend. The degree of curvature of the adjustable elbow is adjustable, for example, by providing a swivel handle and a pull wire on the elbow adjustment device 5. The distal end of the bend-adjusting device 5 is connected to the tubular guide 4, and the hollow passage of the bend-adjusting device communicates with the hollow passage inside the tubular guide 4, forming a hollow passage suitable for accommodating the adjustable bend.

Illustratively, any crimping configuration may be used with the heart valve delivery system including the circumferential stop mechanism described herein. In one embodiment, however, the bend adjustment device 5 is shown in fig. 17-20. The bend-adjusting device 5 may include a housing 51, a rotating handle 52, a guide 53, a threaded tube 54, and a double-sided threaded sleeve 55. The housing 51 of the bending device 5 can be fixedly connected to the outer surface of the tubular guide 4. A rotatable knob 52 is received within the distal opening of the housing 51 for adjusting the circumferential movement of the guide 53, threaded tube 54 and adjustment tube 70. The double-sided threaded sleeve 55 is sleeved on the periphery of the threaded pipe 54 and is connected with the housing 51 with internal threads through a threaded structure. The guide 53 is fixed to the housing 51, and a stopper 531, a first guide rail 532 and a wire fixing end 533 are disposed on the outer circumference of the guide 53. The cable fixing end 533 is axially movable along the first guide rail 532. The wire securing end may include a through hole for securing the wire, and a wire hole 56 adapted for the wire to pass through. The stop collar defines the furthest point at which the fixed end of the pull wire can move.

Threaded tube 54 pulls on the distal end of fixed end 533, which are separate entities for ease of assembly. The whole process of the stay wire is in a tensioning state, when the stay wire moves towards the near end, the threaded pipe 54 drives the fixed end of the stay wire to move, and the tensioning force of the stay wire is gradually increased until the stay wire moves to the limiting ring. When the pull wire is moved to the far end, the resistance of the threaded pipe to the pull wire fixing end is removed due to the fact that the threaded pipe moves to the far end, and the pull wire fixing end moves to the far end along with the threaded pipe under the effect of restoring force. Both ends all are equipped with the breach about the screwed pipe, and the purpose is in making things convenient for the wire to pass to reduce the restriction of both sides of screwed pipe to acting as go-between.

The bend adjustment device 5 further comprises an axial movement prevention member 57 provided at the distal end of the threaded tube 54, which is engaged with the housing 51 to prevent the guide member 53 from moving axially. The bending adjustment device 5 may further comprise an anti-rotation member 58 disposed at a distal end of the axial movement preventing member 56, which is engageable with the housing 51 to prevent circumferential movement of the guide member 53.

Next, the catheter system, the proximal structure of the heart valve delivery system including the circumferential stop mechanism, and the positional relationship between the proximal structure of the heart valve delivery system including the circumferential stop mechanism and the heart valve will be described.

In one embodiment, referring to fig. 19, the distal end of the inner tube 40 is provided with an eversion structure 401 forming a circular ring, the distal end of the middle tube 50 is provided with a first flaring structure 502, and the proximal end of the heart valve is clamped between the circular ring and the flaring structure. In a preferred embodiment, the distal end of the outer tube 60 is provided with a second flaring structure 601, the joint of the middle tube and the second flaring structure comprises a fixing ring, and the proximal end of the heart valve is clamped between the second flaring structure and the fixing ring to limit the radial movement of the heart valve. In a preferred embodiment, the fixing ring is provided with at least one necking groove which is communicated with the outside along the axial direction and is clamped with the far end of the heart valve to limit the axial movement of the heart valve.

The outer tube 60 can extend through the end of the adjustable elbow, and is sleeved on the periphery of the middle tube through a snap ring, the inner tube 40 is sleeved on the periphery of the middle tube 50, and the end of the inner tube comprises a thread guide hole. When the delivery apparatus is used to deliver an aortic valve, the distal end of the valve is sandwiched between the middle tube and the outer tube, and the proximal end is sandwiched between the inner tube and the middle tube. In actual operation, the outer surface of the valve is also sleeved with an introducer to further constrict the valve in an introduction pipe of the introducer (the structure of the introducer is not shown in the document).

Further, as an example, fig. 21 shows a heart valve 2000. The heart valve 2000 may include a connection block 2001 for connection with a catheter system as described herein. The distal end 2002 of the heart valve 2000 may comprise diamond shaped squares. The prosthetic heart valve 2100 may be sutured to the heart valve 2000.

Example 2

The present embodiments provide a method of delivering a heart valve using a heart valve delivery system including a circumferential stop mechanism, comprising the steps of:

s1: a small hole is drilled at the left femoral artery, a guide wire passes through the femoral artery and the ascending aorta from the small hole, crosses over the aortic arch, enters the descending aorta, then enters the aorta along the guide wire together with an outer sheath tube which forms a passage for the delivery system to enter and exit;

s2: the heart valve is pre-loaded in a delivery system by using an introducer, reaches a preliminary set position through an outer sheath, exits from the introducer and releases a positioner of the heart valve;

rotating the bending adjusting device 5 to adjust the heart valve to the central axis of the aorta;

the gear 112 is adjusted by the gear adjusting device 111, so that the external thread sleeve 3 can rotate circumferentially relative to the tubular shell 2, the tubular shell 2 is rotated to drive the heart valve at the far end to rotate circumferentially, the positioner of the heart valve is axially aligned to the sinus bottom of the aortic valve leaflet, and the plug pin is inserted;

the driving nut 8 is rotated to drive the tubular guiding element 4 at the rear part to move towards the far end, and the positioner of the heart valve is stably conveyed to the sinus bottom position of the aortic valve;

releasing the heart valve, pulling out the clamping piece 6, pushing the release tail end 1 to the far end, driving the inner tube 40 to move to the far end, releasing the proximal end of the heart valve, enabling the bottom of the heart valve to abut against the aortic annulus, and clamping the aortic valve leaflet by the outer side wall of the heart valve and the positioner;

rotating the release plate 7, pulling back the release plate towards the proximal end to drive the outer tube 60 to move towards the proximal end, releasing the distal end of the heart valve, automatically expanding the heart valve to a preset size, and releasing the middle tube 50;

after confirming that the heart valve is clamped well, pulling the delivery system to the near end to withdraw out of the body, and completing the implantation of the aortic valve.

It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Any reference sign in a claim should not be construed as limiting the claim concerned.

Claims

1. A heart valve delivery system including a circumferential stop mechanism, comprising:

2. The heart valve delivery system including a circumferential stop mechanism of claim 1, wherein the gear adjustment device comprises:

the axial adjustment assembly faces towards the fixed frame and can partially penetrate through the fixed frame and move axially relative to the fixed frame, the axial adjustment assembly faces towards one end of the gear comprises a gear locking portion used for limiting circumferential rotation of the gear, and when the gear locking portion is clamped with the gear, the gear cannot rotate circumferentially.

3. The heart valve delivery system including a circumferential stop mechanism of claim 2, wherein the axial adjustment assembly comprises:

the internal thread pipe, the internal thread pipe sets up fixed frame keeps away from one side of gear, be used for with the external screw thread pole cooperation is adjusted the axial adjustment subassembly with axial distance between the gear.

4. The heart valve delivery system including a circumferential stop mechanism of claim 3, wherein the other side of the geared lock is provided with a hollow receiving cavity, and one side of the externally threaded rod facing the gear is provided with a connecting block located in the hollow receiving cavity for connecting the externally threaded rod and the geared lock.

5. The heart valve delivery system with the circumferential limiting mechanism according to claim 4, wherein the open end of the hollow accommodating cavity is further provided with a clamping block, and the clamping block limits the connecting block in the hollow accommodating cavity.

6. The heart valve delivery system with the circumferential limiting mechanism as claimed in claim 4, wherein a condensation rod is further arranged between the external threaded rod and the connecting block, and the clamping block limits the condensation rod in the hollow accommodating cavity;

7. The heart valve delivery system with the circumferential limiting mechanism according to claim 6, wherein a gap exists between the side wall of the first clamping block groove close to the condensation rod and the end face of the connecting block on the side far away from the gear, so as to avoid driving the gear locking part to rotate when the external threaded rod rotates.

8. The heart valve delivery system with the circumferential limiting mechanism as recited in claim 6, wherein the cross section of the groove of the second clamping block is semicircular, and the condensation rod is limited in the hollow accommodating cavity by the two clamping blocks.

9. The heart valve delivery system including a circumferential stop mechanism of claim 6, wherein an end of the externally threaded rod distal to the gear is provided with a knob.

10. The heart valve delivery system with a circumferential stop mechanism of claim 6, wherein an end of the externally threaded rod distal from the gear is provided with an externally threaded rod locking slot and an externally threaded rod threaded hole that are recessed toward the externally threaded rod;

11. The heart valve delivery system including a circumferential stop mechanism of any of claims 1-10, wherein the circumferential positioning structure comprises:

wherein the interior space of the first stepped sealing sleeve, the outer surface of the inner tube, and the inner surface of the middle tube form a first cavity having an opening at the proximal end of the middle tube, the interior space of the second stepped sealing sleeve, the outer surface of the middle tube, and the inner surface of the outer tube form a second cavity having an opening at the proximal end of the outer tube, and the first and second stepped sealing sleeves are disposed inside the tubular housing in a direction from the distal end to the proximal end;

wherein the tubular housing is configured such that the catheter system rotates circumferentially in synchrony with the tubular housing as the tubular housing rotates circumferentially.

12. The heart valve delivery system including a circumferential stop mechanism of claim 11, wherein the first stepped sealing sleeve comprises a first sleeve and a second sleeve fixedly connected, the first sleeve being closer to the distal end of the tubular housing than the second sleeve, and the distal end of the first sleeve comprising a sealing structure;

13. The heart valve delivery system including a circumferential stop mechanism of claim 12, wherein the second stepped sealing sleeve comprises a fixedly attached third sleeve, a fourth sleeve, and a fifth sleeve, the fourth sleeve being closer to the distal end of the tubular housing than the third sleeve, the fifth sleeve being closer to the distal end of the tubular housing than the fourth sleeve, and the distal end of the third sleeve comprising a sealing structure;

14. The heart valve delivery system including a circumferential stop mechanism of claim 11, wherein the distal release structure of the release mechanism comprises a release plate and a drive ring, the release plate being butterfly-shaped, the release plate extending through the tubular housing at both ends and engaging the drive ring at the center and being axially movable by the drive ring;

15. The heart valve delivery system including a circumferential stop mechanism of claim 14, wherein the release mechanism is further provided with a radial stop structure comprising a plurality of guide plates disposed axially parallel to the tubular housing such that the drive ring cannot move in a radial direction.

16. The heart valve delivery system including a circumferential stop mechanism of claim 11, wherein the tubular housing includes a release plate anti-malfunction feature comprising a transverse through-hole and a longitudinal through-hole disposed on the tubular housing in communication with each other, the transverse through-hole extending a first distance along the axial direction of the rotational shaft, the longitudinal through-hole extending a second distance along the axial direction of the rotational shaft, the first distance configured to limit axial movement of the release plate along the rotational shaft, the second distance configured to accommodate axial movement of the release plate along the rotational shaft, and the first distance being less than the second distance.

17. The heart valve delivery system including a circumferential stop mechanism as in claim 11, wherein the proximal release structure of the delivery device comprises a hollow central shaft and a plurality of release discs spaced about the hollow central shaft, the central shaft comprising a first hollow passage and a second hollow passage adapted for passage of a guide wire therethrough, the first hollow passage having a diameter less than the second hollow passage, the first hollow passage being closer to the distal end of the delivery device than the second hollow passage, and the inner tube being fixedly attached within the second hollow passage.

18. The heart valve delivery system including a circumferential stop mechanism of claim 17, wherein the proximal end of the proximal release structure is nested within the distal end of the tubular housing, and wherein a maximum radial dimension of the proximal end of the proximal release structure is greater than a maximum dimension of the distal opening of the tubular housing for limiting a maximum distance of axial movement of the proximal release structure in the distal direction.

19. The heart valve delivery system including a circumferential stop mechanism of claim 17, wherein a removable catch is disposed between the proximal hub of the proximal release structure and the distal end of the tubular housing to limit movement of the proximal release structure in the axial direction.

20. The heart valve delivery system with circumferential stop mechanism of any of claims 1-10, wherein the distal end of the inner tube is provided with an eversion structure to form a circular ring, the distal end of the middle tube is provided with a first flaring structure, and the proximal end of the heart valve is clamped between the circular ring and the flaring structure.

21. The heart valve delivery system including a circumferential stop mechanism of claim 20, wherein the outer tube has a second flared structure at a distal end thereof, the middle tube includes a retaining ring at a location where the middle tube engages the second flared structure, and the proximal end of the heart valve engages the second flared structure and the retaining ring to limit radial movement thereof.