Heart valve delivery system with circumferential limiting mechanism

Abstract

The present application discloses a heart valve delivery system with a circumferential limiting mechanism that is accurately positioned and easy to operate, which may include a catheter system for delivering an external heart valve to a target position, a release device for releasing the heart valve, and a positioning device for accurately positioning the heart valve. The positioning device may include a central positioning structure, a circumferential positioning structure, and an axial positioning structure, and the proximal end of the circumferential positioning structure and the distal end of the external threaded sleeve of the axial positioning structure are connected by a circumferential limiting mechanism. The heart valve delivery system with a circumferential limiting mechanism described herein is accurately positioned, easy to operate, and does not damage human tissues.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a heart valve delivery system with a circumferential limiting mechanism and a method for delivering a heart valve. Background Art

[0002] Due to the many advantages of transcatheter surgery, such as less trauma and faster recovery, more and more surgeries are beginning to use transcatheter surgery. The aortic valve replacement has also changed from the early surgical incision method to transcatheter aortic valve replacement.

[0003] The replacement of the aortic valve usually needs to be completed with the help of a heart valve and a heart valve delivery system with a circumferential limiting mechanism. With the continuous innovation of heart valves, higher requirements are also put forward for the heart valve delivery system. Specifically, the heart valve delivery system should not only ensure that the heart valve can be input to the accurate position and angle in the aorta, provide reasonable space for the expansion of the heart valve, but also ensure that no human tissue is damaged during the delivery process.

[0004] Therefore, there is a continuous need in this field to develop a heart valve delivery system with a circumferential limiting mechanism that is accurately positioned and easy to operate, as well as a method for delivering a heart valve. Summary of the Invention

[0005] The purpose of the present application is to provide a heart valve delivery system with a circumferential limiting mechanism that is accurately positioned and easy to operate. The heart valve delivery system with a circumferential limiting mechanism described herein may include a catheter system for delivering an external heart valve to a target position, a release device for releasing the heart valve, and a positioning device for accurately positioning the heart valve. The positioning device may include a central positioning structure, a circumferential positioning structure, and an axial positioning structure, and the proximal end of the circumferential positioning structure and the distal end of the external threaded sleeve of the axial positioning structure are connected by a circumferential limiting mechanism. Specifically, the circumferential limiting mechanism may include a gear adjustment device and a gear, and the gear may be connected to the circumferential positioning structure or the axial positioning structure, or even form an integrated structure with any one of them. By adjusting the gear through the gear adjustment device, the circumferential positioning structure can or cannot rotate circumferentially relative to the axial positioning structure.

[0006] The purpose of the present application is also to provide a method for delivering a heart valve using the heart valve delivery system with a circumferential adjustment mechanism as described above.

[0007] To achieve the above object, the present invention provides the following technical solutions.

[0008] In a first aspect, the present application provides a heart valve delivery system with a circumferential limiting mechanism, characterized in that it includes:

[0009] A catheter system for delivering an external heart valve to a target position, the catheter system comprising an inner tube, a middle tube and an outer tube sleeved in sequence. The proximal end of the heart valve is configured to be clamped between the inner tube and the middle tube, and the distal end of the heart valve is configured to be clamped between the middle tube and the outer tube;

[0010] A release device for releasing the heart valve, the release device comprising a proximal end release structure and a distal end release structure. The proximal end release structure is used to control the axial movement of the outer tube, and the distal end release structure is used to control the axial movement of the inner tube;

[0011] A positioning device for precisely positioning the heart valve, the positioning device comprising a central positioning structure, a circumferential positioning structure and an axial positioning structure. The central positioning structure moves the heart valve to the central axis of the aorta by adjusting the curvature of the distal end of the heart valve delivery system with a circumferential limiting mechanism. The circumferential positioning structure is fixedly connected to the catheter system and is configured to drive the catheter system to rotate around its axis so that the positioning member of the heart valve is axially aligned with the sinus bottom. The axial positioning structure is used to adjust the axial position of the heart valve, including an external thread sleeve and a tubular guide member, and the external thread sleeve is configured to axially move relative to the tubular guide member but not circumferentially move;

[0012] Wherein, the proximal end of the external thread sleeve and the distal end of the tubular guide member are connected by a driving nut, and the driving nut is used to control the axial movement of the external thread sleeve relative to the tubular guide member;

[0013] Wherein, the proximal end of the circumferential positioning structure and the distal end of the external thread sleeve of the axial positioning structure are connected by a circumferential limiting mechanism. The circumferential limiting mechanism comprises a gear adjusting device and a gear. The gear is fixedly connected to the circumferential positioning structure or the axial positioning structure, and the gear adjusting device cooperates with the gear to enable the circumferential positioning structure to circumferentially rotate relative to the axial positioning structure or not.

[0014] In an implementation manner of the first aspect, the gear adjusting device includes:

[0015] A fixed frame with openings at both ends, providing a movement space for the gear adjusting device. The side of the fixed frame facing the positioning device is arc-shaped and matches the shape of the outer shell of the positioning device;

[0016] Axial adjustment assembly, the axial adjustment assembly is configured to be able to partially pass through the fixed frame and perform axial movement relative to the fixed frame. One end of the axial adjustment assembly facing the gear includes a gear locking portion for restricting the circumferential rotation of the gear. When the gear locking portion is engaged with the gear, the gear cannot perform circumferential rotation.

[0017] In an embodiment of the first aspect, the axial adjustment assembly includes:

[0018] Gear locking portion, one side of the gear locking portion facing the gear includes outwardly protruding locking teeth, and the locking teeth can be engaged with the teeth of the gear;

[0019] External threaded rod, used to control the engagement or disengagement of the locking teeth with the gear;

[0020] Internal threaded tube, the internal threaded tube is arranged on the side of the fixed frame away from the gear, and is used to cooperate with the external threaded rod to adjust the axial distance between the axial adjustment assembly and the gear.

[0021] In an embodiment of the first aspect, a hollow accommodation cavity is provided on the other side of the gear locking portion. A connecting block is provided on the side of the external threaded rod facing the gear, and the connecting block is located in the hollow accommodation cavity to connect the external threaded rod and the gear locking portion.

[0022] In an embodiment of the first aspect, a clamping block is further provided at the open end of the hollow accommodation cavity, and the clamping block limits the connecting block in the hollow accommodation cavity.

[0023] In an embodiment of the first aspect, a condensing rod is further provided between the external threaded rod and the connecting block, and the clamping block limits the condensing rod in the hollow accommodation cavity;

[0024] One side of the clamping block close to the hollow accommodation cavity is provided with a first clamping block groove that cooperates with the wall of the hollow accommodation cavity, and one side of the clamping block close to the condensing rod is provided with a second clamping block groove that cooperates with the condensing rod;

[0025] Wherein, the opening diameter of the second clamping block groove is larger than the diameter of the condensing rod, but smaller than the diameters of the connecting block and the external threaded rod.

[0026] In an embodiment of the first aspect, there is a gap between the side wall of the first clamping block groove close to the condensing rod and the end face of the connecting block on the side away from the gear, so as to prevent the gear locking portion from being driven to rotate when the external threaded rod rotates.

[0027] In an embodiment of the first aspect, the cross-section of the second snap-in block groove is semi-circular, and the condensation rod is limited in the hollow accommodation cavity by two snap-in blocks.

[0028] In an embodiment of the first aspect, a knob is provided at one end of the outer threaded rod away from the gear.

[0029] In an embodiment of the first aspect, at one end of the outer threaded rod away from the gear, there are provided an outer threaded rod card slot and an outer threaded rod threaded hole that are recessed towards the outer threaded rod;

[0030] One side of the knob facing the outer threaded rod includes a knob threaded rod and a knob engaging member provided on the outer periphery of the knob threaded rod;

[0031] Wherein, the outer threaded rod card slot cooperates with the knob engaging member, and the outer threaded rod threaded hole cooperates with the knob threaded rod to connect the knob to the outer threaded rod.

[0032] In an embodiment of the first aspect, the circumferential positioning structure includes:

[0033] A tubular housing, the tubular housing includes a housing outer surface, a housing inner surface, and a housing wall extending between the housing outer surface and the housing inner surface, wherein at least a part of the conduit system passes through the hollow interior of the tubular housing;

[0034] An anti-middle tube rotating tube, one end of the anti-middle tube rotating tube is in fluid communication with the internal space of the first stepped sealing sleeve, the other end abuts against the tubular housing and extends through the housing inner surface of the tubular housing, and the anti-middle tube rotating tube also serves as an exhaust tube for the middle tube to discharge the air between the middle tube and the inner tube;

[0035] An anti-outer tube rotating tube, one end of the anti-outer tube rotating tube is in fluid-tightly communicated with the internal space of the second stepped sealing sleeve, the other end abuts against the tubular housing and extends through the housing inner surface of the tubular housing, and the anti-outer tube rotating tube also serves as an exhaust tube for the outer tube to discharge the air between the outer tube and the middle tube;

[0036] Wherein, the internal 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 with an opening at the proximal end of the middle tube, the internal 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 with an opening at the proximal end of the outer tube, and the first stepped sealing sleeve and the second stepped sealing sleeve are arranged inside the tubular housing along the direction from the distal end to the proximal end;

[0037] Wherein, the tubular housing is configured such that when the tubular housing rotates circumferentially, the catheter system rotates circumferentially synchronously with the tubular housing.

[0038] In an embodiment of the first aspect, the first stepped sealing sleeve includes a first sleeve and a second sleeve fixedly connected. The first sleeve is closer to the distal end of the tubular housing than the second sleeve, and the distal end of the first sleeve includes a sealing structure.

[0039] The diameter of the second sleeve is smaller than that of the first sleeve, and the distal end of the middle tube is fixedly connected to the hollow inner space of the second sleeve.

[0040] In an embodiment of the first aspect, the second stepped sealing sleeve includes a third sleeve, a fourth sleeve, and a fifth sleeve fixedly connected. The fourth sleeve is closer to the distal end of the tubular housing than the third sleeve, the fifth sleeve is closer to the distal end of the tubular housing than the fourth sleeve, and the distal end of the third sleeve includes a sealing structure.

[0041] 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 distal end of the outer tube is fixedly connected to the hollow inner space of the fifth sleeve.

[0042] In an embodiment of the first aspect, the distal end release structure of the release device includes a release plate and a drive ring. The release plate is in a butterfly shape. Both ends of the release plate extend through the tubular housing and are snap-connected to the drive ring at the center, and axially move under the drive of the drive ring.

[0043] The drive ring is wound around the outer periphery of the cylindrical outer tube connection portion and is used to drive the tubular housing to move along the axial direction of the tubular housing.

[0044] In an embodiment of the first aspect, the release device is further provided with a radial limiting structure. The radial limiting structure includes a plurality of guide plates arranged parallel to the axial direction of the tubular housing, such that the drive ring cannot move radially.

[0045] In an embodiment of the first aspect, the tubular housing includes a release plate anti-misoperation structure, which includes a transverse through-hole and a longitudinal through-hole that communicate with each other on the tubular housing. The transverse through-hole extends a first distance along the axial direction of the rotation axis, the longitudinal through-hole extends a second distance along the axial direction of the rotation axis. The first distance is configured to limit the axial movement of the release plate along the rotation axis, the second distance is configured to allow the release plate to move axially along the rotation axis, and the first distance is less than the second distance.

[0046] In an embodiment of the first aspect, the proximal release structure of the release device includes a hollow central shaft and a plurality of release discs spaced around the hollow central shaft. The central shaft includes a first hollow channel and a second hollow channel adapted for a guide wire to pass through. The diameter of the first hollow channel is smaller than that of the second hollow channel. The first hollow channel is closer to the distal end of the release device than the second hollow channel, and the inner tube is fixedly connected within the second hollow channel.

[0047] In an embodiment of the first aspect, the proximal end of the proximal release structure is sleeved 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 end opening of the tubular housing, for limiting the maximum axial movement distance of the proximal release structure in the distal direction.

[0048] In an embodiment of the first aspect, a detachable engaging member is provided between the proximal end sleeve of the proximal release structure and the distal end of the tubular housing, for limiting the axial movement of the proximal release structure.

[0049] In an embodiment of the first aspect, the distal end of the inner tube is provided with an outwardly folded structure to form a ring, and the distal end of the middle tube is provided with a first outward expansion structure. The proximal end of the heart valve is clamped between the ring and the outward expansion structure.

[0050] In an embodiment of the first aspect, the distal end of the outer tube is provided with a second outward expansion structure. The connection between the middle tube and the second outward expansion structure includes a fixing ring. The proximal end of the heart valve is clamped between the second outward expansion structure and the fixing ring to limit its radial movement.

[0051] Compared with the prior art, the beneficial effects of the present application are as follows:

[0052] (1) The heart valve delivery system with a circumferential limiting mechanism has accurate positioning and is easy to operate;

[0053] (2) The release plate anti-misoperation structure is provided on the tubular housing to limit the axial movement of the release plate when the release plate does not need to move;

[0054] (3) The distal end of the middle tube includes a heart valve fixing ring for clamping the heart valve within the fixing ring, which can avoid damage to blood vessel tissues by the heart valve;

[0055] When delivering a heart valve using the heart valve delivery system with a circumferential limiting mechanism described herein, the proximal end (inflow end) of the heart valve is engaged by the inner tube and the middle tube, and the distal end (outflow end) of the heart valve is engaged by the middle tube and the outer tube. When releasing the heart valve, the proximal end of the heart valve is released by pushing the inner tube to the left, and the distal end of the heart valve is released by retracting the outer tube. This can avoid damage to the valve or repositioning of the located valve during the process where competing products all push to the left (left ventricular side). BRIEF DESCRIPTION OF THE DRAWINGS

[0056] The technical features and advantages of the present invention can be more fully understood by combining the accompanying drawings and referring to the following detailed description. In the drawings:

[0057] Figure 1 is a schematic diagram of a heart valve delivery system with a circumferential limiting mechanism according to an embodiment of the present application;

[0058] Figure 2 is Figure 1 a partial enlarged view at G in;

[0059] Figure 3 is a front view of a heart valve delivery system with a circumferential limiting mechanism according to an embodiment of the present application;

[0060] Figure 4 is a schematic diagram of a heart valve delivery system with a circumferential limiting mechanism according to an embodiment of the present application;

[0061] Figure 5 is an exploded view of a heart valve delivery system with a circumferential limiting mechanism according to an embodiment of the present application;

[0062] Figure 6A is a schematic diagram of a gear adjustment device according to an embodiment of the present application, Figure 6B is a schematic diagram of a clamping block of a gear adjustment device according to an embodiment of the present application, Figure 6C is a schematic diagram of a hollow accommodation cavity of a gear adjustment device according to an embodiment of the present application;

[0063] Figure 7A is an exploded view of a gear adjustment device according to an embodiment of the present application, Figure 7B is a schematic diagram of an axial adjustment assembly, Figure 7C is a schematic diagram of the structure of a knob, Figure 7D is a schematic diagram of the structure of the end of an external threaded rod;

[0064] Figure 8 is a top view of a heart valve delivery system with a circumferential limiting mechanism according to an embodiment of the present application;

[0065] Figure 9Ais Figure 8 a sectional view along section line A-A in

[0066] Figure 9B is Figure 8 a schematic diagram of the release end structure of the heart valve delivery system with a circumferential adjustment mechanism shown in

[0067] Figure 10A a schematic diagram of the sealing structure inside the tubular housing according to an embodiment of the present application, Figure 10B a schematic diagram of the outer tube sealing structure according to an embodiment of the present application;

[0068] Figure 11 a front view of the tubular housing according to an embodiment of the present application;

[0069] Figure 12 a schematic diagram of the proximal end of the external thread sleeve according to an embodiment of the present application;

[0070] Figure 13 an exploded view showing the tubular guide according to an embodiment of the present application;

[0071] Figure 14 an exploded view showing the tubular guide and the conical guide structure according to an embodiment of the present application;

[0072] Figure 15 an exploded view showing the tubular guide and the conical guide structure from another angle according to an embodiment of the present application;

[0073] Figure 16 a schematic diagram showing the conical guide structure according to an embodiment of the present application;

[0074] Figure 17 a schematic diagram of the internal structure of the heart valve delivery system with a circumferential limit mechanism according to another embodiment of the present application;

[0075] Figure 18 shows Figure 17 a partial enlarged view at B in

[0076] Figure 19 shows Figure 17 a schematic diagram of the distal end in

[0077] Figure 20 a schematic diagram of the threaded tube according to an embodiment of the present application;

[0078] Figure 21 a schematic diagram of a heart valve according to an embodiment. Detailed implementation manners

[0079] Unless otherwise defined, technical terms or scientific terms used in this specification and claims shall have the ordinary meanings as understood by those of ordinary skill in the technical field to which the present invention pertains.

[0080] In the description of the present invention, it should be understood that the orientation or positional relationships indicated by the terms "center", "longitudinal", "transverse", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. are based on the orientation or positional relationships shown in the drawings. These are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation to the present invention.

[0081] In addition, the terms "first", "second", etc. are only used for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined with "first", "second", etc. may explicitly or implicitly include one or more of such features. In the description of the present invention, unless otherwise stated, the meaning of "a plurality" is two or more.

[0082] In the description of the present invention, it should be noted that unless otherwise clearly specified and limited, the terms "mounted", "connected", and "coupled" should be understood in a broad sense. For example, it may be a direct connection, a detachable connection, or an integral connection; it may be a mechanical connection or an electrical connection; it may be directly connected or indirectly connected through an intermediate medium, and it may be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood through specific circumstances.

[0083] As described herein, when describing a heart valve, a release tip, a tubular housing, an external threaded sleeve, a tubular housing, a tubular guide, a bending structure, a guide wire, and a catheter system, etc., "proximal" refers to the side of the catheter system when the heart valve is in an extended state or the side in the direction of the end manipulated by the user. Correspondingly, "distal" refers to the side away from the catheter system when the heart valve is in an extended state or the side away from the direction of the end manipulated by the user. In this application, when describing the heart valve, "proximal end" refers to the side close to the apex of the heart when the heart valve is in an extended state. Correspondingly, "distal end" refers to the side away from the apex of the heart when the heart valve is in an extended state. Since the heart valve described herein is delivered through the aorta by catheter, the distal end and the proximal end of the heart refer to the same position, and the proximal and distal ends refer to the same position.

[0084] Example 1

[0085] This embodiment provides a heart valve delivery system 100 with a circumferential limiting mechanism.

[0086] First, referring to Figures 1-5 , along the direction from the distal end to the proximal end, the heart valve delivery system 100 with a circumferential limiting mechanism of this embodiment may sequentially include a release tip 1, a tubular housing 2, an external thread sleeve 3, a tubular guide 4, and a conical guide structure 10. The proximal end of the release tip 1 may be sleeved within the distal end opening of the tubular housing 2. The proximal end of the tubular housing 2 and the distal end of the external thread sleeve 3 may be connected by a circumferential limiting mechanism 11. The proximal end of the external thread 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 connection nut 9. The heart valve delivery system 100 with a circumferential limiting mechanism may further include a bending adjustment device 5, and the proximal end of the bending adjustment device 5 is fixedly connected to the tubular guide 4.

[0087] In addition, the heart valve delivery system 100 with a circumferential limiting mechanism may further include a catheter system. The catheter system can be used to deliver an external heart valve to a target position. The catheter system includes an inner tube, a middle tube, and an outer tube that are sequentially sleeved. The proximal end of the heart valve is configured to be snap-fitted between the inner tube and the middle tube, and the distal end of the heart valve is configured to be snap-fitted between the middle tube and the outer tube. The inner tube, the middle tube, and the outer tube in the catheter system all pass through the proximal end of the conical guide structure 10 and extend a predetermined distance.

[0088] In one embodiment, the heart valve delivery system 100 with a circumferential limiting mechanism includes a release device for releasing the heart valve. The release device includes a proximal release structure and a distal release structure. The proximal release structure is used to control the axial movement of the outer tube, and the distal release structure is used to control the axial movement of the inner tube. In this embodiment, the proximal release structure may be the release tip 1 for releasing the proximal end of the heart valve. In addition, the distal release structure may include a release plate 7 disposed inside the tubular housing 2 and protruding from the outside of the tubular housing 2 for releasing the distal end of the heart valve.

[0089] In one embodiment, a heart valve delivery system with a circumferential limiting mechanism may include a positioning device for precisely positioning a heart valve. The positioning device includes a central positioning structure, a circumferential positioning structure, and an axial positioning structure. The circumferential positioning structure is fixedly connected to the catheter system and is configured to drive the catheter system to rotate around its axis so that the positioning member of the heart valve is axially aligned with the sinus bottom. The axial positioning structure is used to adjust the axial position of the heart valve and includes an external thread sleeve and a tubular guide member, and the external thread sleeve is configured to be axially movable relative to the tubular guide member but not circumferentially movable. In this embodiment, the central positioning structure may include a bending adjustment device 5 for moving the heart valve to the central axis of the aorta by adjusting the curvature of the distal end of the heart valve delivery system with a circumferential limiting mechanism. In this embodiment, the circumferential positioning structure may include a tubular housing 2, an anti-rotation tube 213 for the middle tube, and an anti-rotation tube 215 for the outer tube disposed within the tubular housing 2. The tubular housing 2 is configured such that when the tubular housing 2 rotates circumferentially, it drives the catheter system to rotate circumferentially synchronously with the tubular housing 2. In this embodiment, the axial positioning structure may include an external thread sleeve 3 and a tubular guide member 4, and the external thread sleeve 3 and the tubular guide member 4 are connected by a driving nut 8. By rotating the driving nut 8, the external thread sleeve 3 can be axially moved relative to the tubular guide member 4.

[0090] Compared with the prior art, the improvement of the present application lies first in the connection manner between the tubular housing 2 and the external thread sleeve 3. In one embodiment, the proximal end of the tubular housing 2 of the circumferential positioning structure and the distal end of the external thread sleeve 3 of the axial positioning structure are connected by a circumferential limiting mechanism 11. The circumferential limiting mechanism 11 includes a gear adjustment device 111 and a gear 112. The gear 112 is fixedly connected to the circumferential positioning structure or the axial positioning structure, and the gear adjustment device 111 cooperates with the gear 112 to enable or disable the circumferential rotation of the circumferential positioning structure relative to the axial positioning structure. In a specific embodiment, the gear 112 may even be integrally formed with any one of the connections to the circumferential positioning structure or the axial positioning structure. By adjusting the gear 112 with the gear adjustment device 111, the circumferential positioning structure can be enabled or disabled to rotate circumferentially relative to the axial positioning structure. In other words, when the gear adjustment device 111 and the gear 112 are in the first position, the circumferential positioning structure can rotate circumferentially relative to the axial positioning structure, and when the gear adjustment device 111 and the gear 112 are in the second position, the circumferential positioning structure cannot rotate circumferentially relative to the axial positioning structure. By operating the gear adjustment device 111, the relative position of the gear adjustment device 111 and the gear 112 can be switched between the first position and the second position.

[0091] Referring to FIGS. 6-7, in a specific embodiment, the gear adjustment device 111 may include a fixed frame 1101 and an axial adjustment assembly. The fixed frame 1101 may have openings at both ends, providing a movement space for the gear adjustment device 111. The fixed frame 1101 may be fixedly connected to the circumferential positioning structure or the axial positioning structure of the positioning device. The side of the fixed frame 1101 facing the positioning device is arc-shaped, matching the shape of the outer shell of the positioning device, so that the gear adjustment device 111 can be fixedly attached to the surface of the positioning device. In this embodiment, the axial adjustment assembly is configured to pass through the fixed frame 1101 and perform axial movement relative to the fixed frame 1101. One end of the axial adjustment assembly facing the gear 112 includes a gear locking portion 1103 for restricting the circumferential rotation of the gear. When the gear locking portion 1103 is engaged with the gear 112, the gear 112 cannot rotate circumferentially.

[0092] In a preferred embodiment, the axial adjustment assembly may include a gear locking portion 1103, an external threaded rod 1105, and an internal threaded tube 1106. One side of the gear locking portion 1103 facing the gear 112 includes outwardly protruding locking teeth 1107, which are adapted to be engaged with the teeth of the gear 112. A hollow receiving cavity 1108 is provided on the other side of the gear locking portion 1103. In a specific embodiment, the gear locking portion 1103 may include a plurality of locking teeth 1107, the cross-sections of which are trapezoidal, and the cross-sectional length of the end closer to the gear 112 is less than the cross-sectional length of the end farther from the gear 112. In addition, the contour of the groove formed between adjacent locking teeth 1107 may match the gear profile of the gear 112, so that the gear 112 can be limited and the teeth of the gear 112 will not be damaged.

[0093] In one embodiment, the internally threaded tube 1106 is disposed on a side of the fixed frame 1101 away from the gear 112 and is used to cooperate with the externally threaded rod 1105 to adjust the axial distance between the axial adjustment assembly and the gear 112. In a specific embodiment, the externally threaded rod 1105 is used to control the engagement or disengagement of the locking teeth with the gear. A connecting block 1109 is provided on a side of the externally threaded rod 1105 facing the gear 112, and the connecting block 1109 is located in the hollow accommodation cavity 1108 to connect the externally threaded rod 1105 and the gear locking portion 1103. A clamping block 1112 is further provided at an opening end of the hollow accommodation cavity 1108, and the clamping block 1112 limits the connecting block 1109 within the hollow accommodation cavity 1108. A condensing rod 1110 is further provided between the externally threaded rod 1105 and the connecting block 1109, and the clamping block 1112 limits the condensing rod 1110 within the hollow accommodation cavity 1108. A first clamping block groove 1113 that cooperates with the wall of the hollow accommodation cavity 1108 is provided on a side of the clamping block 1112 close to the hollow accommodation cavity 1108, and a second clamping block groove 1114 that cooperates with the condensing rod is provided on a side of the clamping block 1112 close to the condensing rod 1110. In this embodiment, the opening diameter of the second clamping block groove 1114 is larger than the diameter of the condensing rod 1110 but smaller than the diameters of the connecting block 1109 and the externally threaded rod 1105, so that the condensing rod 1110 can be limited within the hollow accommodation cavity 1108.

[0094] In a specific embodiment, there is a gap between a side wall 11131 of the first clamping block groove 1113 close to the externally threaded rod 1105 and an end face of the connecting block 1109 on a side away from the gear, for avoiding driving the gear locking portion to rotate when the externally threaded rod 1105 rotates.

[0095] In a specific embodiment, the cross-section of the second clamping block groove 1114 is semi-circular, and the condensing rod 1110 of the externally threaded rod 1105 is clamped with the hollow accommodation cavity 1108 through two clamping blocks 1112. These two clamping blocks 1112 may have a symmetrical structural shape. Those skilled in the art can understand that, for the convenience of positioning and installation, the clamping block 1112 and the hollow accommodation cavity 1108 may further include corresponding installation through holes.

[0096] In this embodiment, by rotating the outer threaded rod 1105 relative to the inner threaded tube 1106, the outer threaded rod 1105 can move axially, driving the gear locking portion 1103 provided at the end of the outer threaded rod 1105 to move together. When the gear locking portion 1103 engages with the teeth of the gear 112, the gear 112 cannot rotate. When the gear locking portion 1103 is completely disengaged from the teeth of the gear 112, the gear 112 can rotate freely. Since the gear 112 is fixedly connected to the circumferential positioning structure or the axial positioning structure, the circumferential positioning structure and the axial positioning structure can rotate relative to each other at this time.

[0097] In another embodiment, in order to reduce the rotation difficulty of the outer threaded rod 1105, a knob 1121 can be provided at one end of the outer threaded rod 1105 away from the gear 112. In a preferred embodiment, in order to ensure a tight connection between the outer threaded rod 1105 and the knob 1121, an outer threaded rod groove 1115 and an outer threaded rod threaded hole 1116 recessed towards the outer threaded rod 1105 can be provided at one end of the outer threaded rod 1105 away from the gear 112. Correspondingly, one side of the knob facing the outer threaded rod includes a knob threaded rod 1122 and a knob engaging member 1123 provided on the outer periphery of the knob threaded rod 1122. In this embodiment, the outer threaded rod groove 1115 cooperates with the knob engaging member 1123, and the outer threaded rod threaded hole 1116 cooperates with the knob threaded rod 1122 to connect the knob 1121 to the outer threaded rod 1105.

[0098] Next, each part of the heart valve delivery system 100 including the circumferential limiting mechanism and their positional relationships will be described in more detail with reference to the accompanying drawings.

[0099] Next, the structure of the release end 1 and the positional relationship between the release end 1 and the tubular housing 2 will be described.

[0100] The release end 1 is used to release the proximal end of the heart valve by pushing the inner tube forward. In one embodiment, refer to Figure 8As shown in FIGS. 8 and 9, the release end 1 includes a hollow central shaft 101 and a plurality of release discs 102 spaced around the hollow central shaft. The central shaft includes a first hollow channel 103 and a second hollow channel 104 adapted for a guide wire to pass through. The diameter of the first hollow channel 103 is smaller than that of the second hollow channel 104, and the first hollow channel 103 is closer to the distal end of the release device than the second hollow channel 104. The inner tube is fixedly connected within the second hollow channel 104. In a specific embodiment, since the diameter of the guide wire is smaller than that of the inner tube, the diameter of the first hollow channel 103 is smaller than that of the second hollow channel 104. In a specific embodiment, the inner tube can be snap-fitted into the second hollow channel 104, and then sequentially passes through the tubular housing 2, the external thread sleeve 3, and the tubular guide 4, and extends towards the proximal end of the heart valve delivery system with a circumferential limiting mechanism. In a specific embodiment, along the direction from the distal end to the proximal end, the diameters of the plurality of release discs 102 can first decrease and then increase, thereby increasing the friction force and facilitating grasping.

[0101] The distal end of the release end 1 can be connected to the proximal end of the tubular housing 2. In a specific embodiment, the proximal end of the release end 1 is sleeved within the distal end of the tubular housing 2, and the maximum radial dimension of the proximal end of the release end 1 is greater than the maximum dimension of the opening at the distal end of the tubular housing, for limiting the maximum axial movement distance of the release end 1 in the distal end direction. This setting can prevent the release end 1 from detaching from the tubular housing 2.

[0102] In another embodiment, a engaging member 6 is provided between the release end 1 and the tubular housing 2, for filling the gap between the release end 1 and the tubular housing 2 and preventing the release end 1 from pushing the inner tube in the proximal end direction. When it is necessary to release the proximal end of the heart valve, the engaging member 6 is removed, and the release end 1 is pushed in the proximal end direction, and the inner tube also moves in the proximal end direction accordingly. When the inner tube is separated from the middle tube, the proximal end of the heart valve can be inflated.

[0103] Next, the structure of the tubular housing 2 and the positional relationship between the tubular housing 2 and the external thread sleeve 3 will be described.

[0104] In one embodiment, referring to Figures 4-5 and Figures 8-11, the circumferential positioning structure of the heart valve delivery system 100 with a circumferential limiting mechanism may include a tubular housing 2, an anti-middle tube rotating tube 213, and an anti-outer tube rotating tube 215. The tubular housing 2 may include 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 part of the catheter system passes through the hollow interior of the tubular housing 2. One end of the anti-middle tube rotating tube 213 is in fluid communication with the internal space of the first stepped sealing sleeve 25, and the other end abuts against the tubular housing 2 and extends through the tubular housing inner surface 22. The anti-middle tube rotating tube 213 also serves as an evacuation tube for the middle tube to discharge the air between the middle tube and the inner tube. One end of the anti-outer tube rotating tube 215 is in fluid communication with the internal space of the second stepped sealing sleeve 26, and the other end abuts against the tubular housing 2 and extends through the tubular housing inner surface 22. The anti-outer tube rotating tube 215 also serves as an evacuation tube for the outer tube to discharge the air between the outer tube and the middle tube. The internal 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 having an opening at the proximal end of the middle tube. The air between the middle tube and the inner tube can be discharged by injecting physiological saline into the first cavity. Similarly, the internal space of the second stepped sealing 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 discharged by injecting physiological saline into the second cavity. In one embodiment, the first stepped sealing sleeve 25 and the second stepped sealing sleeve 26 are arranged inside the tubular housing 2 along the direction from the distal end to the proximal end.

[0105] In a specific embodiment, the first stepped sealing sleeve 25 includes a first sleeve 251 and a second sleeve 252 fixedly connected. The first sleeve 251 is 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 that of the first sleeve 251, and the distal end of the middle tube is fixedly connected to the hollow internal space of the second sleeve 252. For example, the distal end of the middle tube can be snap-fitted into the hollow internal space of the second sleeve. In one embodiment, the distal end of the first sleeve 251 includes a sealing structure.

[0106] In a specific embodiment, the second stepped sealing sleeve includes a third sleeve 261, a fourth sleeve 262, and a fifth sleeve 263 that are fixedly connected. The fourth sleeve 262 is closer to the distal end of the tubular housing than the third sleeve 261, and the fifth sleeve 263 is 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 the diameter of the third sleeve 261, and the diameter of the fifth sleeve 263 is smaller than the diameter of the fourth sleeve 262. 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 be snap-fitted into the hollow inner space of the fifth sleeve. In one embodiment, the distal end of the third sleeve 261 includes a sealing structure.

[0107] In this embodiment, the middle tube is fixedly connected to the inner space of the second sleeve 252, and one end of the middle tube rotation prevention tube 213 is fixedly connected to the first sleeve 251, and the other end is stuck in the housing wall of the tubular housing 2. Therefore, the middle tube will rotate circumferentially synchronously with the tubular housing 2. Similarly, the outer tube is fixedly connected to the inner space of the fifth sleeve 263, and one end of the outer tube rotation prevention tube 215 is fixedly connected to the third sleeve 261, and the other end is stuck in the housing wall of the tubular housing 2. Therefore, the outer tube will rotate circumferentially synchronously with the tubular housing 2.

[0108] 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 following will refer to Figures 8-11 to describe the sealing structure at the distal end of the third sleeve 261. Generally speaking, a sealing gasket is squeezed between two snap-fit sleeves for sealing, and a stepped hole is provided in the outer sleeve. A perforation is provided in the middle of the sealing gasket. It has a structure with a thick edge and a thin middle, meeting both sealing performance and easy penetration.

[0109] Refer to Figures 8-11 , the distal end of the first sleeve 251 may include first snap holes 253 arranged at circumferential intervals and a first stepped hole 254 provided inside it. The proximal end of the first sealing sleeve 255 includes a first sealing protrusion 256 that can cooperate with the first snap holes 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 snaps into the first snap holes 253, and at the same time, the first sealing gasket 257 is squeezed into the stepped hole 254 of the first sleeve 251 to achieve the sealing of the inner tube.

[0110] Similarly, referring to FIGS. 9-11, the distal end of the third sleeve 261 may include circumferentially spaced second snap holes 264 and a second stepped hole 265 disposed therein. The proximal end of the second sealing sleeve 266 includes a second sealing protrusion 267 that can cooperate with the second snap hole 264. When the proximal end of the second sealing sleeve 266 is sleeved within the distal end of the third sleeve 261, the second sealing protrusion 267 snaps into the second snap hole 264, and at the same time, the second sealing gasket 268 is squeezed into the second stepped hole 265 of the third sleeve 261 to achieve the sealing of the outer tube.

[0111] In a preferred embodiment, the first stepped hole 254 and the second stepped hole 265 are provided with chamfers to cooperate with the thicker outer periphery of the gasket to enhance the sealing effect.

[0112] In one embodiment, referring to Figures 4-5 and Figure 8 -9, the distal end release structure of the release device is further provided inside the tubular housing 2, which includes a release plate 7, a radial limiting structure, and a driving ring 205. The release plate 7 may have a structure similar to a butterfly. The two ends of the release plate 7 may extend through the tubular housing 2, and the ends thereof may include spaced protrusion structures 210, which have an anti-slip effect. The center of the release plate 7 is snap-connected to the driving ring 205, and the two ends extend through the tubular housing 2. Driven by the driving ring 205, the release plate 7 is driven to move axially. In one embodiment, the radial limiting structure includes a plurality of guide plates 212 arranged parallel to the axis of the tubular housing, such that the driving ring 205 can only rotate or move along the axial direction of the tubular housing, but cannot move along the radial direction. In a specific embodiment, the radial limiting structure may include three guide plates 212 with an arcuate end point, and the arc can cooperate with the outer contour of the driving ring 205. In one embodiment, the driving ring 205 is wound around the outer periphery of the cylindrical outer tube connection portion for driving the tubular housing to move along the axial direction of the tubular housing. In a specific embodiment, the driving ring is disposed near the proximal end of the fourth sleeve 262. In one embodiment, the release plate 7 and the driving ring 205 are not in direct axial contact and can rotate freely circumferentially to prevent the valve at the distal end from rotating when the release plate rotates.

[0113] In one embodiment, referring to Figure 11, the tubular housing 2 may include a misoperation prevention structure for the release plate, which includes a laterally through hole 221 and a longitudinally through hole 222 that communicate with each other. The longitudinally through hole 222 is a rectangular structure, and its width is slightly larger than the thickness of the release plate 7. For example, the width of the longitudinally through hole 222: the thickness of the release plate 7 = 1.1 - 1.3. The release plate 7 can move along the length direction of the longitudinally through hole 222, playing a role in guiding the release plate 7. The lateral through hole extends axially along the rotation axis for a first distance, and the longitudinal through hole extends axially along the rotation axis for a second distance. The first distance is configured to limit the axial movement of the release plate along the rotation axis, and the second distance is configured to be suitable for the release plate to move axially along the rotation axis, and the first distance is less than the second distance. In one embodiment, the tubular housing 2 may further include a raised point 217, which is disposed in the lateral through hole 221 for restricting the free movement of the release plate. To avoid misoperation of the release plate 7 during the operation, a stepped hole is provided on the tubular housing. When not released, the release plate is located at the lower part of the stepped hole, that is, in the lateral through hole 221, and the release plate is restricted from axial movement.

[0114] In another embodiment, the proximal end of the tubular housing 2 may further include a gear receiving cavity 290. The hollow internal space of the gear receiving cavity 290 can be used to receive the gear 112, and its outer housing can be used to mount the fixed frame 1101.

[0115] Next, the structure of the tubular guide 4 will be described.

[0116] The externally threaded sleeve 3 can be connected to the tubular guide 4 through the drive nut 8 to jointly form an axial positioning structure for adjusting the axial position of the heart valve.

[0117] Reference Figure 12 , the outer periphery of the proximal end of the externally threaded sleeve 3 may include an external thread 302 for cooperating 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 that are recessed toward the inside of the externally threaded sleeve 3 and perpendicular to the thread. The guide grooves 304 can be engaged with a guide plate 490 provided inside the distal end of the tubular guide 4. Therefore, when the drive nut 8 is rotated, the externally threaded sleeve 3 can be axially moved relative to the tubular guide 4, but the externally threaded sleeve 3 will not rotate relative to the tubular guide 4. The externally threaded sleeve 3 further includes an externally threaded sleeve hollow channel 305 for accommodating guide wires and catheters.

[0118] Reference Figures 13-16, for the convenience of assembly, the drive nut 8 can be used in cooperation with the snap ring 81 and the connecting ring 82. The drive nut 8 may include a drive nut assembly hole 801 provided on the proximal end face of the drive nut 8 and a drive nut stepped hole 802 that is recessed a predetermined distance from the proximal end face of the drive nut 8 toward the distal end of the drive nut 8. Correspondingly, the snap ring 81 includes a snap ring assembly hole 811 provided on the distal end face of the snap ring 81 and a snap ring stepped hole 812 that is recessed a predetermined distance from the distal end face of the snap ring 81 toward the proximal end of the snap ring. The drive nut assembly hole 801 corresponds to the snap ring assembly hole 811 for fixing the drive nut 8 and the snap ring 81. The connecting ring 82 can be provided at the distal end of the tubular guide 4 and is adapted to be received in the cavity formed by the drive nut stepped hole 802 and the snap ring stepped hole 812.

[0119] The proximal end of the tubular guide 4 can be connected to the conical guide structure 10 through a connecting nut 9. Refer to Figure 14 , the proximal end of the tubular guide 4 can be provided with an external thread 405 that mates with the internal thread of the connecting nut 9. In addition, an annular connecting disk 406 can be provided between the proximal end of the tubular guide 4 and the distal end of the conical guide structure 10. A first snap ring 407 and a second snap ring 408 can be provided on the side of the annular connecting disk 406 facing the conical guide structure 10, where the diameter of the second snap ring 408 is greater than that of the first snap ring 407. Such a structure makes the contact portion between the annular connecting disk 406 and the conical guide structure 10 gradually shorter in the radial direction from the middle, and the structure is more stable. The annular connecting disk also includes a connecting rivet 409 and a wire-drawing hole 410 adapted for a wire to pass through. In a specific embodiment, as Figure 20 shown, the conical guide structure 10 also includes a wire-drawing channel 1006 adapted for a wire to pass through. Refer to Figure 21 , the angle α between the wire-drawing channel 1006 and the central axis of the conical guide structure 10 is not greater than 30° (not shown in the figure). The conical guide structure 10 may include a protruding tube 1001 and a conical outer shell 1002. The protruding tube can extend through the central opening of the annular connecting disk, and the end of the protruding tube may include a concave platform 1003 that is recessed toward the proximal end of the protruding tube for mating with a sealing ring. In addition, refer to Figure 16 , at least three stepped baffles 1004 can be provided inside the conical outer shell and outside the protruding tube. The stepped baffles 1004 extend along the axial direction of the protruding tube, and the end of each baffle facing the distal end of the protruding tube includes a first groove 1007 and a second groove 1008 that are recessed toward the proximal end of the protruding tube. The first groove 1007 is closer to the protruding tube and is used to cooperate with the first snap ring 407. The second groove 1008 is closer to the conical outer shell 10002 and is used to cooperate with the second snap ring 408 to achieve double sealing. The distal end of the conical guide structure 10 may also include a mounting hole 1005 for cooperating with the connecting rivet 409.

[0120] Next, the structure of the bending adjustment device 5 and the positional relationship between the bending adjustment device 5 and the tubular guide 4 will be briefly described.

[0121] Reference Figure 17 , the heart valve delivery system 100 including a circumferential limiting mechanism may further include a bending adjustment device 5. The bending adjustment device 5 includes a hollow channel of the bending adjustment device adapted to accommodate an adjustable bending tube. The bending degree of the adjustable bending tube is adjustable. For example, it can be adjusted by setting a rotary handle and a wire on the bending adjustment device 5. The distal end of the bending adjustment device 5 is connected to the tubular guide 4, and the hollow channel of the bending adjustment device communicates with the hollow channel inside the tubular guide 4 to form a hollow channel adapted to accommodate the adjustable bending tube.

[0122] It should be noted that any bending adjustment structure can be applied to the heart valve delivery system including a circumferential limiting mechanism described herein. However, in one embodiment, the bending adjustment device 5 is as Figures 17-20 shown. The bending adjustment device 5 may include a housing 51, a rotary handle 52, a guide member 53, a threaded tube 54, and a double-sided threaded sleeve 55. The housing 51 of the bending adjustment device 5 can be fixedly connected to the outer surface of the tubular guide 4. The rotary handle 52 can be sleeved within the distal opening of the housing 51 for adjusting the circumferential movement of the guide member 53, the threaded tube 54, and the bending tube 70. The double-sided threaded sleeve 55 is sleeved on the outer periphery of the threaded tube 54 and is connected to the housing 51 having internal threads through a threaded structure. The guide member 53 is relatively fixed to the housing 51, and a limiting ring 531, a first guide rail 532, and a wire fixing end 533 are provided on the outer periphery of the guide member 53. The wire fixing end 533 can move axially along the first guide rail 532. The wire fixing end may include a through hole for fixing the wire and a wire hole 56 adapted for the wire to pass through. The limiting ring defines the farthest point where the wire fixing end can move.

[0123] At the distal end of the wire fixing end 533 of the threaded tube 54, for the convenience of assembly, the two are independent individuals. The wire is in a tensioned state throughout the process. When moving proximally, the threaded tube 54 drives the wire fixing end to move, and at this time, the tension of the wire gradually increases until it reaches the limiting ring. When moving distally, since the threaded tube moves distally, the resistance to the wire fixing end is removed, and the wire fixing end moves distally with the threaded tube under the action of the restoring force. Notches are provided at both the left and right ends of the threaded tube for the convenience of wire passing and to reduce the restriction of the two sides of the threaded tube on the wire.

[0124] The bending adjustment device 5 further includes an anti-axial movement 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 include an anti-rotation member 58 provided at the distal end of the anti-axial movement member 57, which can be engaged with the housing 51 to prevent the guide member 53 from moving circumferentially.

[0125] Next, the catheter system, the structure of the proximal end of the heart valve delivery system with a circumferential limiting mechanism, and the positional relationship between the structure of the proximal end of the heart valve delivery system with a circumferential limiting mechanism and the heart valve will be described.

[0126] In one embodiment, referring to FIG. 19, a distal end of the inner tube 40 is provided with an everted structure 401 to form a ring, and a distal end of the middle tube 50 is provided with a first outward expansion structure 502. The proximal end of the heart valve is clamped between the ring and the outward expansion structure. In a preferred embodiment, a distal end of the outer tube 60 is provided with a second outward expansion structure 601. The connection between the middle tube and the second outward expansion structure includes a fixing ring. The proximal end of the heart valve is clamped between the second outward expansion structure and the fixing ring to restrict its radial movement. In a preferred embodiment, the fixing ring is axially provided with at least one constriction groove communicating with the outside, which is clamped with the distal end of the heart valve to restrict the axial movement of the heart valve.

[0127] The outer tube 60 can extend through the end of the adjustable bending tube, and is sleeved on the outer periphery of the middle tube through a snap ring. The inner tube 40 is sleeved on the outer periphery of the middle tube 50, and a guide wire hole 41 is included at the end of the inner tube. When using this delivery device to deliver the aortic valve, the distal end of the valve is clamped between the middle tube and the outer tube, and the proximal end is clamped between the inner tube and the middle tube. In actual operation, an introducer is also sleeved outside the valve, and the valve is further constricted in the introducer tube (the structure of the introducer is not shown in this document).

[0128] In addition, as an example, Figure 21 a heart valve 2000 is shown. The heart valve 2000 may include a connection block 2001 for connecting to the catheter system described herein. The distal end 2002 of the heart valve 2000 may include a diamond grid. The artificial heart valve 2100 may be sutured to the heart valve 2000.

[0129] Embodiment 2

[0130] This embodiment provides a method for delivering a heart valve using a heart valve delivery system with a circumferential limiting mechanism, which includes the following steps:

[0131] S1: Make a small hole at the left femoral artery, insert a guide wire from the small hole through the femoral artery, ascending aorta, across the aortic arch, and after entering the descending aorta, reach the outside of the descending aorta. The dilator and the outer sheath tube together enter the aorta along the guide wire, and the dilator is withdrawn. The outer sheath tube forms a passage for the delivery system to enter and exit.

[0132] S2: Pre-load the heart valve in the delivery system using an introducer, and reach the preliminary set position through the outer sheath tube.

[0133] Withdraw the introducer and release the positioner of the heart valve.

[0134] The rotation and bending adjustment device 5 adjusts the heart valve to the central axis of the aorta;

[0135] Adjust the gear 112 through the gear adjustment device 111, so that the external thread sleeve 3 can rotate circumferentially relative to the tubular housing 2. Rotate the tubular housing 2 to drive the heart valve at the distal end to rotate circumferentially, so that the locator of the heart valve is axially aligned with the sinus bottom of the aortic valve leaflet, and insert the pin;

[0136] Rotate the drive nut 8 to drive the rear tubular guide 4 to move distally, and steadily transport the locator of the heart valve to the sinus bottom position of the aortic valve;

[0137] Release the heart valve, pull out the engaging member 6, push the release end 1 distally to drive the inner tube 40 to move distally, the proximal end of the heart valve is released, and the bottom abuts against the aortic annulus. The outer wall of the heart valve and the locator together clamp the aortic valve leaflet;

[0138] Rotate the release plate 7, pull the release plate proximally to drive the outer tube 60 to move proximally, the distal end of the heart valve is released and automatically expands to a predetermined size, and the middle tube 50 is released;

[0139] After confirming that the heart valve is clamped properly, pull the delivery system proximally out of the body to complete the implantation of the aortic valve.

[0140] For those skilled in the art, it is obvious that the present invention is not limited to the details of the above exemplary embodiments, and can be implemented in other specific forms without departing from the spirit or basic characteristics of the present invention. Therefore, from any point of view, the embodiments should be regarded as exemplary and non-limiting. The scope of the present invention is defined by the appended claims rather than the above description. Therefore, all changes falling within the meaning and scope of the equivalent elements of the claims are intended to be included in the present invention. Any reference signs in the claims should not be regarded as limiting the claims involved.

Claims

1. A heart valve delivery system with a circumferential limiting mechanism, characterized in that, it comprises: A catheter system for delivering an external heart valve to a target position. The catheter system includes an inner tube, a middle tube, and an outer tube sleeved in sequence. The proximal end of the heart valve is configured to be clamped between the inner tube and the middle tube, and the distal end of the heart valve is configured to be clamped between the middle tube and the outer tube; A release device for releasing the heart valve. The release device includes a proximal release structure and a distal release structure. The proximal release structure is used to control the axial movement of the outer tube, and the distal release structure is used to control the axial movement of the inner tube; A positioning device for accurately positioning the heart valve. The positioning device includes a central positioning structure, a circumferential positioning structure, and an axial positioning structure. The central positioning structure moves the heart valve to the central axis of the aorta by adjusting the curvature of the distal end of the heart valve delivery system with a circumferential limiting mechanism. The circumferential positioning structure is fixedly connected to the catheter system and is configured to drive the catheter system to rotate around its axis so that the positioning member of the heart valve is axially aligned with the sinus bottom. The axial positioning structure is used to adjust the axial position of the heart valve, including an external thread sleeve and a tubular guide member, and the external thread sleeve is configured to be able to move axially relative to the tubular guide member but not circumferentially; Wherein, the proximal end of the external thread sleeve and the distal end of the tubular guide member are connected by a driving nut, and the driving nut is used to control the axial movement of the external thread sleeve relative to the tubular guide member; Wherein, the proximal end of the circumferential positioning structure and the distal end of the external thread sleeve of the axial positioning structure are connected by a circumferential limiting mechanism. The circumferential limiting mechanism includes a gear adjusting device and a gear. The gear is fixedly connected to the circumferential positioning structure or the axial positioning structure, and the gear adjusting device cooperates with the gear to enable the circumferential positioning structure to rotate circumferentially relative to the axial positioning structure or not; Wherein, the circumferential positioning structure includes: A tubular housing, the tubular housing includes a housing outer surface, a housing inner surface, and a housing wall extending between the housing outer surface and the housing inner surface, wherein at least a part of the catheter system passes through the hollow interior of the tubular housing; A middle tube anti-rotation tube, one end of the middle tube anti-rotation tube is in fluid communication with the inner space of the first stepped sealing sleeve, the other end abuts against the tubular housing and extends through the housing inner surface of the tubular housing. The middle tube anti-rotation tube also serves as an exhaust tube for the middle tube, used to discharge the air between the middle tube and the inner tube; An outer tube anti-rotation tube, one end of the outer tube anti-rotation tube is in fluid-tight communication with the inner space of the second stepped sealing sleeve, the other end abuts against the tubular housing and extends through the housing inner surface of the tubular housing. The outer tube anti-rotation tube also serves as an exhaust tube for the outer tube, used to discharge the air between the outer tube and the middle tube; Among them, the internal 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 with an opening at the proximal end of the middle tube. The internal 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 with an opening at the proximal end of the outer tube. And the first stepped sealing sleeve and the second stepped sealing sleeve are arranged inside the tubular housing along the direction from the distal end to the proximal end; Among them, the tubular housing is configured such that when the tubular housing rotates circumferentially, the catheter system rotates circumferentially synchronously with the tubular housing.

2. The heart valve delivery system with a circumferential limiting mechanism according to claim 1, characterized in that, The gear adjustment device includes: A fixed frame with openings at both ends, providing a movement space for the gear adjustment device. The side of the fixed frame facing the positioning device is arc-shaped and matches the shape of the outer shell of the positioning device; An axial adjustment component, which is configured to be able to partially pass through the fixed frame and move axially relative to the fixed frame. One end of the axial adjustment component facing the gear includes a gear locking portion for restricting the circumferential rotation of the gear. When the gear locking portion is engaged with the gear, the gear cannot rotate circumferentially.

3. The heart valve delivery system with a circumferential limiting mechanism according to claim 2, characterized in that, The axial adjustment component includes: A gear locking portion. The side of the gear locking portion facing the gear includes outwardly protruding locking teeth, which can be engaged with the teeth of the gear; An outer threaded rod for controlling the engagement or disengagement of the locking teeth with the gear; An inner threaded tube, which is arranged on the side of the fixed frame away from the gear and is used to cooperate with the outer threaded rod to adjust the axial distance between the axial adjustment component and the gear.

4. The heart valve delivery system with a circumferential limiting mechanism according to claim 3, characterized in that, On the other side of the gear locking portion, there is a hollow accommodating cavity. On the side of the outer threaded rod facing the gear, there is a connecting block, and the connecting block is located in the hollow accommodating cavity to connect the outer threaded rod and the gear locking portion.

5. The heart valve delivery system with a circumferential limiting mechanism according to claim 4, characterized in that, At the open end of the hollow accommodating cavity, there is also a clamping block, and the clamping block limits the connecting block in the hollow accommodating cavity.

6. The heart valve delivery system with a circumferential limiting mechanism according to claim 5, characterized in that, There is also a condensing rod between the outer threaded rod and the connecting block, and the clamping block limits the condensing rod in the hollow accommodating cavity; On the side of the clamping block close to the hollow accommodating cavity, there is a first clamping block groove cooperating with the wall of the hollow accommodating cavity, and on the side of the clamping block close to the condensing rod, there is a second clamping block groove cooperating with the condensing rod; Wherein, the opening diameter of the second clamping block groove is larger than the diameter of the condensation rod, but smaller than the diameters of the connecting block and the external threaded rod.

7. The heart valve delivery system with a circumferential limiting mechanism as claimed in claim 6, characterized in that there is a gap between the side wall of the first clamping block groove close to the condensation rod and the end face of the connecting block away from the gear side, so as to prevent the rotation of the gear locking part when the external threaded rod rotates.

8. The heart valve delivery system with a circumferential limiting mechanism as claimed in claim 6, characterized in that the cross-section of the second clamping block groove is semi-circular, and the condensation rod is limited in the hollow accommodating cavity by two clamping blocks.

9. The heart valve delivery system with a circumferential limiting mechanism as claimed in claim 6, characterized in that a knob is provided at one end of the external threaded rod away from the gear.

10. The heart valve delivery system with a circumferential limiting mechanism as claimed in claim 9, characterized in that an external threaded rod groove and an external threaded rod threaded hole recessed towards the external threaded rod are provided at one end of the external threaded rod away from the gear; one side of the knob towards the external threaded rod includes a knob threaded rod and a knob engaging member provided on the outer periphery of the knob threaded rod; wherein, the external threaded rod groove cooperates with the knob engaging member, and the external threaded rod threaded hole cooperates with the knob threaded rod to connect the knob to the external threaded rod.

11. The heart valve delivery system with a circumferential limiting mechanism as claimed in claim 1, characterized in that the first stepped sealing sleeve includes a fixedly connected first sleeve and a second sleeve, the first sleeve is closer to the distal end of the tubular housing than the second sleeve, and the distal end of the first sleeve includes a sealing structure; the diameter of the second sleeve is smaller than that of the first sleeve, and the distal end of the middle tube is fixedly connected to the hollow internal space of the second sleeve.

12. The heart valve delivery system with a circumferential limiting mechanism as claimed in claim 11, characterized in that the second stepped sealing sleeve includes a fixedly connected third sleeve, a fourth sleeve and a fifth sleeve, the fourth sleeve is closer to the distal end of the tubular housing than the third sleeve, the fifth sleeve is closer to the distal end of the tubular housing than the fourth sleeve, and the distal end of the third sleeve includes a sealing 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 distal end of the outer tube is fixedly connected to the hollow internal space of the fifth sleeve.

13. The heart valve delivery system with a circumferential limiting mechanism as claimed in claim 1, characterized in that the distal end release structure of the release device includes a release plate and a driving ring, the release plate is in a butterfly shape, both ends of the release plate extend through the tubular housing and the center is clamped with the driving ring, and it moves axially under the drive of the driving ring; the driving ring is arranged around the outer periphery of the cylindrical outer tube connecting part and is used to drive the tubular housing to move along the axial direction of the tubular housing.

14. The heart valve delivery system with a circumferential limiting mechanism as claimed in claim 13, wherein, the release device is further provided with a radial limiting structure, which includes a plurality of guide plates arranged parallel to the axial direction of the tubular housing, so that the driving ring cannot move radially.

15. The heart valve delivery system with a circumferential limiting mechanism as claimed in claim 1, wherein, the tubular housing includes a misoperation prevention structure for the release plate, which includes a transverse through hole and a longitudinal through hole that are communicated with each other on the tubular housing. The transverse through hole extends a first distance along the axial direction of the rotation axis, and the longitudinal through hole extends a second distance along the axial direction of the rotation axis. The first distance is configured to limit the axial movement of the release plate along the rotation axis, and the second distance is configured to be suitable for the release plate to move axially along the rotation axis, and the first distance is less than the second distance.

16. The heart valve delivery system with a circumferential limiting mechanism as claimed in claim 1, wherein, the proximal release structure of the release device includes a hollow central shaft and a plurality of release disks sleeved on the hollow central shaft at intervals. The central shaft includes a first hollow channel and a second hollow channel suitable for a guide wire to pass through. The diameter of the first hollow channel is smaller than that of the second hollow channel. The first hollow channel is closer to the distal end of the release device than the second hollow channel, and the inner tube is fixedly connected within the second hollow channel.

17. The heart valve delivery system with a circumferential limiting mechanism as claimed in claim 16, wherein, the proximal end of the proximal release structure is sleeved 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 opening at the distal end of the tubular housing, for limiting the maximum axial movement distance of the proximal release structure in the distal direction.

18. The heart valve delivery system with a circumferential limiting mechanism as claimed in claim 16, wherein, a detachable engaging member is provided between the proximal end sleeve of the proximal release structure and the distal end of the tubular housing, for limiting the axial movement of the proximal release structure.

19. The heart valve delivery system with a circumferential limiting mechanism as claimed in any one of claims 1-10, wherein, the distal end of the inner tube is provided with an everted structure, forming a ring. The distal end of the middle tube is provided with a first outward expansion structure. The proximal end of the heart valve is clamped between the ring and the outward expansion structure.

20. The heart valve delivery system with a circumferential limiting mechanism as claimed in claim 19, wherein, the distal end of the outer tube is provided with a second outward expansion structure. The connection between the middle tube and the second outward expansion structure includes a fixing ring. The proximal end of the heart valve is clamped between the second outward expansion structure and the fixing ring to limit its radial movement.

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