CN115919508B

CN115919508B - Release method of artificial heart valve

Info

Publication number: CN115919508B
Application number: CN202310044380.8A
Authority: CN
Inventors: 曾桂容; 张志飞; 马仁政; 刘兆刚; 马甜; 刘伟伟; 郑明睿
Original assignee: Hangzhou Qiming Medical Devices Co ltd
Current assignee: Hangzhou Qiming Medical Devices Co ltd
Priority date: 2022-12-20
Filing date: 2023-01-30
Publication date: 2023-10-31
Anticipated expiration: 2043-01-30
Also published as: CN115919508A

Abstract

The application discloses a release method of a prosthetic heart valve, wherein a delivery system comprises a catheter assembly and a control handle, the catheter assembly comprises an inner sheath tube assembly and an outer sheath tube, and the control handle comprises a first handle and a second handle which are in sliding fit; when the interventional instrument is released, the second handle and the first handle are in a first combined position, and the outer sheath is driven to move only by the first handle to expose the loading position; after the interventional instrument is released, the second handle drives the inner sheath tube assembly to slide to a second position relative to the first handle to enable the outer sheath tube to cover the loading position; a first locking mechanism for holding the first handle and the second handle in the first position and a second locking mechanism for holding the first handle and the second handle in the second position are also provided, and unlocking members are provided for the respective locking mechanisms. The application can quickly adjust the relative position of the catheter assembly to achieve better control effect.

Description

Release method of artificial heart valve

Technical Field

The application relates to the field of medical equipment, in particular to a release method of a prosthetic heart valve.

Background

The delivery system of the interventional instrument generally comprises a control handle arranged at a proximal end for one side of an operator to control, a plurality of elongated sliding nested catheters, wherein the proximal end of the control handle is a control end and is connected with each catheter, and the distal end of the control handle is a working end and can be inserted into a body to complete delivery, release or recovery of the interventional instrument through mutual cooperation, so that the control handle is generally provided with sliding or rotating components for driving relative movement between the catheters along the axial direction.

With the development of medical equipment, more requirements are put on the operation functions of the control handle such as conveying, releasing and recovering the interventional instrument by operators such as clinicians, and particularly after the interventional instrument is released, the operators need to withdraw the whole conveying system from the body, and before the whole conveying system is withdrawn, the relative positions of the catheters need to be quickly adjusted, so that the catheter assembly is quickly restored to a state suitable for running in the body, but the existing conveying system is retracted only through threaded transmission, and the adjusting efficiency is low.

Disclosure of Invention

In order to solve the technical problems, the application discloses a release method of a prosthetic heart valve, which comprises the following steps:

a prosthetic heart valve, the prosthetic heart valve having an expanded state and a compressed state;

a delivery system having opposite distal and proximal ends and an axial direction extending therebetween, the delivery system comprising a catheter assembly and a control handle connected to the proximal end of the catheter assembly, the catheter assembly comprising an inner sheath assembly and an outer sheath, a radial gap at the distal ends of both the inner sheath assembly and the outer sheath being a loading site for receiving a prosthetic heart valve, the inner sheath assembly and the outer sheath being configured for relative movement such that the outer sheath encases or exposes the loading site;

The prosthetic heart valve is releasably coupled to the loading site;

the control handle is characterized by comprising a first handle and a second handle which are in sliding fit;

the first handle is used for being connected with the outer sheath tube;

the second handle is positioned at the proximal end side of the first handle and is used for being connected with the inner sheath tube assembly, and the second handle is provided with a first position combined with the first handle and a second position sliding a preset distance towards the proximal end;

a first locking mechanism mounted to the second handle and cooperating with a proximal portion of the first handle to retain the first handle in a first position;

an extension sleeve, a proximal end of the extension sleeve being connected to the second handle, a distal end of the extension sleeve extending into the interior of the first handle;

a second locking mechanism mounted to the first handle and cooperating with the extension sleeve to retain the second handle in a second position;

releasing the prosthetic heart valve, comprising:

the first handle and the second handle remain in a first position, delivering the prosthetic heart valve to a designated location;

controlling, by the first handle, the outer sheath to slide proximally relative to the inner sheath assembly, exposing the outer sheath to the loading site to release the prosthetic heart valve;

Unlocking the first locking mechanism, controlling the inner sheath assembly to slide proximally relative to the outer sheath by the second handle, such that the outer sheath covers the loading site, while the second locking mechanism maintains the first handle and the second handle in a second position;

the catheter assembly is moved proximally away from the designated location by the first handle and the second handle.

The following provides several alternatives, but not as additional limitations to the above-described overall scheme, and only further additions or preferences, each of which may be individually combined for the above-described overall scheme, or may be combined among multiple alternatives, without technical or logical contradictions.

Optionally, when the prosthetic heart valve is released to a predetermined course while the outer sheath is controlled to slide proximally relative to the inner sheath assembly by the first handle, confirming whether the state of the prosthetic heart valve is expected, and further driving the outer sheath to fully expose the loading site after confirming the expected state.

Optionally, the length of the prosthetic heart valve that has been exposed to the outer sheath when released to a predetermined procedure is 55% -80% of the total axial length of the prosthetic heart valve.

Optionally, when the prosthetic heart valve is released to a predetermined process, if the state of the prosthetic heart valve is not in accordance with the expectation, the first handle controls the outer sheath to slide distally relative to the inner sheath assembly, so that the outer sheath recoils the prosthetic heart valve, and then the state of the prosthetic heart valve is adjusted accordingly.

Optionally, a prompt component is configured in the first handle, and the prompt component provides a hand feeling response and/or an acoustic response in a vibration mode when the artificial heart valve is released to a preset process.

Optionally, the prompting component comprises a first component and a second component which act with each other, a movable seat is axially and slidably arranged on the first handle, the movable seat is connected with the outer sheath tube, and the second component is arranged on the movable seat;

the first handle is further rotatably provided with a driving sleeve, the driving sleeve is provided with internal threads and is arranged on the periphery of the movable seat, the movable seat is provided with transmission teeth matched with the internal threads, and the first component is arranged on the driving sleeve.

Optionally, the first component is a prompting latch, the second component is a first elastic member connected to the movable seat, the first elastic member and the prompting latch are propped against each other in a state of being opposite to each other, and the deformation of the first elastic member at least allows the prompting latch to rotate along with the driving sleeve and pass over the first elastic member;

The inner sheath tube assembly and the outer sheath tube are provided with:

a first relative position, the outer sheath surrounding the loading site;

a second relative position, wherein the outer sheath exposes a portion of the loading site, and the prosthetic heart valve is released to a predetermined procedure.

Optionally, the prompting latches include two groups, one group of prompting latches is responsive to the first elastic member in the first relative position, and the other group of prompting latches is responsive to the first elastic member in the second relative position.

Optionally, the first handle includes at least a supporter, the supporter with movable seat sliding fit, the movable seat includes:

the base body is at least partially a sliding part positioned in the support body;

the transmission teeth are fixed on the sliding part;

the first elastic piece is fixed to the sliding part through the middle piece, the middle piece is located outside the supporting body, the first elastic piece is a bridge arm with two ends fixed to the middle piece, and the middle area of the bridge arm is matched with the prompting latch.

Optionally, the second handle includes:

the second shell, in the first position, the proximal end of the first handle is used as a connecting section and extends into the distal end of the second shell, and the connecting section is of a hollow structure for extending a pipe fitting;

A tube fitting secured within the second housing for connection with the proximal end of the inner sheath assembly, the proximal end of the extension sleeve being connected to the tube fitting;

the first locking mechanism includes:

the first limiting piece is movably arranged in the second shell and is in a locking state matched with the connecting section and a releasing state for releasing the matching, and a first locking groove matched with the first limiting piece is formed in the outer wall of the connecting section;

the second elastic piece acts between the second shell and the first limiting piece to drive the first limiting piece to enter a locking state;

the control button is used as an unlocking component and is movably embedded in the second shell, and is linked with the first limiting piece to drive the first limiting piece to enter a locking state;

when the first locking mechanism is unlocked, the control button is operated.

Optionally, the first locking mechanism is two sets, first limiting pieces in the two sets are stacked side by side along the axial direction, and the first locking piece in each first limiting piece is matched with the first locking groove on the corresponding side of the connecting section;

the second elastic pieces and the control buttons in the two sets are distributed in a mirror image mode; one end of the second elastic piece in each sleeve is propped against the first limiting piece in the sleeve, and the other end of the second elastic piece in each sleeve is propped against the control button in the other sleeve;

When the first locking mechanisms are unlocked, the control buttons in the two sets of first locking mechanisms are pressed in opposite directions at the same time.

Optionally, the second locking mechanism includes:

the second limiting piece is sleeved on the periphery of the extension sleeve, a second locking groove matched with the second limiting piece is formed in the periphery of the extension sleeve, a second locking piece matched with the second locking groove is arranged at the inner edge of the second limiting piece, and the second limiting piece has a locking state matched with the extension sleeve and a releasing state for releasing the matching; the second limiting piece is positioned in the connecting section, the unlocking button penetrates through and is exposed to the side wall of the connecting section, the first handle and the second handle are positioned at the first position, and the second shell shields the unlocking button; the first handle and the second handle are in a second position, and the unlocking button is exposed to the second shell;

the spring acts between the first handle and the second limiting piece to drive the second limiting piece to enter a locking state;

the unlocking button is used as an unlocking component and is fixed on the second limiting piece to drive the second limiting piece to enter a unlocking state, and the unlocking button and the spring are positioned on two opposite sides of the second limiting piece.

The conveying system provided by the application can achieve better control effects in the aspects of conveying, releasing, recycling and other operation functions of the interventional instrument, improves the operation experience of operators such as clinicians and the like, and the specific beneficial technical effects are further explained in the specific embodiments.

Drawings

FIG. 1 is a perspective view of the present application;

FIG. 2 is a partial exploded view of the present application;

FIG. 3 is a schematic view of the structure of the fully exposed interventional instrument of the sheath according to the present application;

FIG. 4 is a schematic view of the structure of the sheath wrapping loading position according to the present application;

FIG. 5 is a partial cross-sectional view of the driven member mated with the driving member in accordance with the present application;

FIG. 6 is a schematic diagram of the structure of the movable seat and the driving sleeve and the prompting component of the application;

FIG. 7 is a partial cross-sectional view of the present application showing engagement of the latch with the first resilient member;

FIG. 8 is a schematic view illustrating the structure of the latch of FIG. 7 abutting against the first elastic member;

FIGS. 9 a-9 c are schematic views illustrating the movement of an outer sheath relative to an inner sheath in accordance with the present application;

FIG. 10 is a schematic view illustrating a structure of the first elastic member abutting against the first set of indicator teeth according to the present application;

FIG. 11 is a schematic diagram showing a structure of the first elastic member abutting against the second set of indicator teeth according to the present application;

FIG. 12 is a partial cross-sectional view of a drive sleeve and support body of a dual layer construction in accordance with the present application;

FIG. 13 is a schematic view showing the structure of the movable seat with double-layer structure and the support body in the present application;

FIG. 14 is a schematic view of the first elastic member, the indicator latch and related components according to the present application;

FIG. 15 is a schematic view showing the combination of a first handle and a second handle according to the present application;

FIG. 16 is a schematic view of the first and second handles of the present application in a second position;

FIG. 17 is an exploded view of the first locking mechanism of the present application;

FIG. 18 is a schematic view showing the structure of the second limiting member in the releasing state according to the present application;

FIG. 19 is a partial cross-sectional view of the present application taken along the latch;

FIG. 20 is a schematic view of a locking portion of the present application;

FIG. 21 is a cross-sectional view of the present application taken along the direction of the operating ring;

FIG. 22 is a schematic view of the construction of the drive sleeve, elastic locking ring, and operating ring of the present application;

FIG. 23 is a schematic view showing the cooperation of the locking portion and the operating ring in the present application

FIG. 24 is a schematic view of a first handle according to the present application;

FIG. 25 is a partial cross-sectional view of a first handle of the present application;

reference numerals in the drawings are described as follows:

1. an interventional instrument;

2. a catheter assembly; 21. an inner sheath assembly; 211. a guide head; 212. a clamping part; 22. an outer sheath;

3. A control handle; 30. a first handle; 31. a locking part; 311. a force application part; 3111. a first anti-slip tooth; 312. an operating ring; 3121. a working section; 3122. a protrusion; 3123. an inner convex region; 3124. a recessed region; 313. a cylindrical structure; 3131. hollow areas; 32. a support body; 321. a guide groove; 33. a middle sleeve; 34. a first housing; 341. an indication window; 342. a shielding part; 35. a connection section; 351. a first locking groove;

4. a driving mechanism; 41. a follower; 41a, a movable seat; 411. a travel indicating element; 412. a drive tooth; 413. a base; 4131. a sliding part; 42. a driving member; 42a, a drive sleeve; 421. a plug section; 4211. a third anti-slip tooth; 4212. a limit flange; 4213. a limiting ring; 422. an internal thread; 423. a bushing; 4231. an accommodation hole; 4232. a limit step; 424. a housing;

5. an elastic locking ring; 51. a second anti-slip tooth;

6. a prompting component; 60. prompting the latch; 60a, a first set of cue teeth; 60b, a second set of cue teeth; 61. a body; 62. convex teeth; 63. a space occupying member;

7. a first elastic member; 71. a protrusion; 72. bridge arms;

8. a middleware; 81. positioning holes; 82. a deformation release port;

9. a second handle; 901. a second housing; 9011. a guide groove; 9012. a hollowed-out area; 9013. a reinforcing seat; 9014. a stabilizing groove; 902. a pipe joint;

91. A first locking mechanism; 91a, a first locking mechanism; 91b, a first locking mechanism; 911. a first limiting member; 911a, a first limiting member; 911b, a first limiting member; 9111. a first locking member; 9112. a first positioning column; 9113. a second positioning column; 912. a second elastic member; 912a, a second elastic member; 912b, a second elastic member; 913. a control knob; 913a, control buttons; 913b, control buttons; 9131. a first receiving groove; 9132. a second receiving groove; 9133. an anti-drop edge; 9134. a lug;

92. a second locking mechanism; 921. a second limiting piece; 9211. a second locking member; 9212. a guide post; 922. a spring; 923. unlocking the button;

93. an extension sleeve; 931. a second locking groove; 932. an anti-falling structure; 9321. an outer protruding portion; 9322. a stop portion; 933. a clamping structure; 934. convex ribs.

Detailed Description

The following description of the embodiments of the present application will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When an element is referred to as being "disposed on" another element, it can be directly on the other element or intervening elements may also be present.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the description of the application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and/or" as used herein includes any and all combinations of one or more of the associated listed items.

Referring to fig. 1-4, a method of releasing a prosthetic heart valve is disclosed, comprising a prosthetic heart valve having an expanded state and a compressed state, and a delivery system for releasing the prosthetic heart valve, the prosthetic heart valve being accessible from the expanded state and maintained in the compressed state by a loading device. The delivery system utilized has opposite distal and proximal ends, and an axial direction extending therebetween, the distal end being understood to be the end relatively remote from the operator and the proximal end being the end relatively close to the operator.

The delivery system comprises a catheter assembly 2 and a control handle 3 connected to the proximal end of the catheter assembly 2, the catheter assembly 2 comprising an inner sheath assembly 21 and an outer sheath 22, the radial clearance of the distal ends of both the inner sheath assembly 21 and the outer sheath 22 being a loading site for receiving an interventional instrument, it being understood that the loading site is for receiving a prosthetic heart valve in a compressed state, and the prosthetic heart valve is coupled to the loading site, the manner of coupling of the two being provided below. The prosthetic heart valve is disengaged from the loading position after full release.

The inner sheath assembly 21 and the outer sheath 22 are configured to be capable of relative movement such that the outer sheath 22 encloses or exposes the loading site (i.e., encloses or releases the prosthetic heart valve), i.e., the relative position of the two tubing pieces, is reflected in the release state of the prosthetic heart valve.

The control handle 3 comprises a first handle 30 and a second handle 9 in sliding fit, the first handle 30 being connected to the outer sheath 22, the second handle 9 being located on the proximal side of the first handle and being adapted to be connected to the inner sheath assembly, the second handle 9 having a first position (as shown in fig. 3) associated with the first handle 30 and a second position (as shown in fig. 4) sliding proximally a predetermined distance, i.e. a change in the relative position of the first handle and the second handle is also reflected in a change in the relative position of the inner sheath assembly 21 and the outer sheath 22, the first position corresponding to an outer sheath cladding loading position, as shown in the figures, and the second position corresponding to an outer sheath exposure loading position.

For switching and holding of these two positions, the control handle is realized by a first locking mechanism 91, an extension sleeve 93 and a second locking mechanism 92 which are built in.

The first locking mechanism 91 is mounted to the second handle 9 and cooperates with the proximal portion of the first handle 30 to retain the first handle 30 in the first position, and the second handle is slidable proximally relative to the first handle when the first locking mechanism 91 is unlocked.

The extension sleeve is a connecting part between the two handles, the proximal end of the extension sleeve 93 is connected to the second handle 9, and the distal end of the extension sleeve 93 protrudes into the interior of the first handle 30.

A second locking mechanism 92 is mounted to the first handle 30 and cooperates with the extension sleeve 93 to retain the second handle 9 in the second position. The second locking mechanism 92 is hidden inside the second handle 9 when in the first position, so that the operator cannot directly apply force, and the second locking mechanism 92 is exposed only after the second handle 9 slides proximally, so that the operator can switch the operation.

An operator such as a clinician utilizes the above-mentioned conveying system to place a prosthetic heart valve (hereinafter also referred to as an interventional instrument 1) at a specified position in a body and release the prosthetic heart valve, and the operator can observe indexes such as the position, the spatial posture, the matching relation with peripheral tissues and the like of the prosthetic heart valve in the body by combining an imaging device and the like in the release process to determine the release time of the prosthetic heart valve.

As shown in fig. 3-4, the distal end of the outer sheath 22 abuts or slightly wraps around the proximal end of the guide head 211 to cover the radial gap to prevent exposure of the interventional instrument as the catheter assembly 2 is advanced in the body. Upon release of the prosthetic heart valve (i.e. the interventional instrument 1), it comprises:

the first handle 30 and the second handle 9 are maintained in the first position to deliver the prosthetic heart valve to the desired position with the inner sheath assembly 21 and the outer sheath 22 in the initial position, i.e., the outer sheath fully wrapped around the loading position as shown in fig. 1, and in a condition suitable for in vivo navigation;

controlling the outer sheath 22 to slide proximally relative to the inner sheath assembly 21 by the first handle 30 such that the outer sheath 22 exposes the loading site to release the prosthetic heart valve, the distance between the distal end of the outer sheath 22 and the guide head 211 being maximized (distance L as shown in the figures);

unlocking the first locking mechanism 91, controlling the inner sheath assembly 21 to slide proximally relative to the outer sheath 22 by the second handle 9, so that the outer sheath 22 covers the loading site, the second handle 9 can slide proximally in the direction of arrow a as shown in fig. 4, the inner sheath assembly 21 is also retracted rapidly proximally in the direction of arrow B, the second handle 9 stroke is also L, and the second locking mechanism 92 holds the first handle 30 and the second handle 9 in the second position;

The catheter assembly 2 is moved proximally away from the designated location by the first handle 30 and the second handle 9, eventually withdrawing the catheter assembly 2 from the body.

When the outer sheath is controlled to slide proximally relative to the inner sheath assembly by the first handle, the state of the artificial heart valve is confirmed to be in accordance with the expectation when the artificial heart valve is released to a preset process, and it is understood that an operator confirms that the indexes such as the position, the spatial posture, the matching relation with the peripheral tissues and the like of the artificial heart valve in the body are in accordance with the expectation by using imaging equipment and the like, and after the expectation is confirmed, the outer sheath is further driven to completely expose the loading position (namely, the interventional instrument 1 is completely released as shown in fig. 3).

Wherein, when the prosthetic heart valve is released to a preset process, the length of the prosthetic heart valve which is exposed to the outer sheath tube 22 is 55% -80% of the total axial length of the prosthetic heart valve. Preferably, the length of the prosthetic heart valve exposed to the outer sheath 22 is 60% -70% of the total axial length of the prosthetic heart valve

When the artificial heart valve is released to a preset process, if the state of the artificial heart valve does not accord with expectations (namely, operators confirm that indexes such as the position, the spatial posture and the like of the artificial heart valve in the body do not accord with expectations), the outer sheath tube is controlled to slide distally relative to the inner sheath tube assembly through the first handle, so that the outer sheath tube wraps the artificial heart valve again, and then the state of the artificial heart valve is correspondingly adjusted.

Referring to fig. 5 to 14, the first handle is provided with the prompting component 6, the prompting component 6 can be connected with the first handle 30 in a split or integrated mode, and the prompting component provides a hand feeling response and/or an acoustic response in a vibration mode when the artificial heart valve is released to a preset process.

The control handle 3 comprises a first handle 30 and a plurality of sets of driving mechanisms arranged on the first handle 30, and each set of driving mechanism is in transmission fit with a corresponding pipe fitting in the catheter assembly 2, so that the driving mechanism can operate specific pipe fittings, and finally the operation effects of conveying, releasing, recovering and the like of the interventional instrument are finished.

One set of driving mechanism 4 comprises a driven member 41 and a driving member 42 arranged on the periphery of the driven member 41, wherein the driving member can adopt a driving sleeve 42a with a hollow cylindrical structure, and the driven member can adopt a movable seat 41a.

The movable seat 41a is axially and slidably arranged on the first handle and is connected with the outer sheath tube 22; the driving sleeve 42a is rotatably arranged on the first handle 30, is provided with internal threads 422 and is positioned at the periphery of the movable seat; the movable seat is provided with a transmission tooth 412 matched with the internal thread, so that the movable seat is meshed with the internal thread, and the purpose of transmission is achieved.

The prompting assembly 6 comprises a first part and a second part which act with each other, the second part is mounted on the movable seat, the first part is mounted on the driving sleeve, and an operator can drive the movable seat 41a and the outer sheath 22 to slide by rotating the driving sleeve 42 a.

When the prosthetic heart valve is released to a predetermined progression and the outer sheath 22 moves to a predetermined relative position with respect to the inner sheath assembly 21, the first and second members abut one another in the predetermined relative position, the first member passing over the second member creating a sound, jarring effect, ultimately imparting a changing effect on the feel and/or sound to the operator. The following provides an improved manner of prompting the assembly.

The second part and the first part are abutted against each other along the radial direction of the control handle under the interaction state so as to release the axial movement of each other, so that the parts can be more flexibly configured, and the space is reasonably utilized.

As shown in fig. 7 and 8, the first member is preferably a prompting latch 60, the second member is a first elastic member 7 connected to the movable seat 41a, the first elastic member and the prompting latch are abutted against each other in a state of being opposite to each other (i.e. abutted against each other along the radial direction of the control handle), and the deformation amount of the first elastic member at least allows the prompting latch to pass over the first elastic member, so that the prompting latch generates a sound effect every time the prompting latch passes over the first elastic member, and finally, the change effect of the hand feeling and/or the sound is transmitted to the operator.

The outer sheath 22 and the inner sheath assembly 21 have at least the following relative positions therebetween:

a release position, in which the outer sheath 22 is moved proximally relative to the inner sheath assembly 21 to fully expose the loading position, allowing the interventional instrument to be fully released from the delivery system;

the full recovery position or initial position refers to the fact that the outer sheath 22 completely covers the loading position and the interventional instrument, or the interventional instrument can be further withdrawn from the body after being released, and the distal end of the outer sheath is mutually engaged with the guide head 211;

a semi-release position, meaning that the outer sheath 22 partially exposes the loading site, the distal portion of the interventional instrument has been released, but the proximal end, and particularly the engagement with the mounting head, remains bound by the outer sheath 22. In general, when the interventional device is a valve system, all of the leaflets in the valve are exposed to the outer sheath, the leaflets can work normally and are in a semi-release state, and 60% -70% of the total length of the valve is usually exposed to the outer sheath and is in a semi-release state.

At this time, the outer sheath 22 can still be moved distally to retrieve the interventional instrument 1, and if the release progress exceeds this position, it is difficult or even impossible to retrieve the interventional instrument 1.

The interventional instrument 1 is generally engaged with the engagement portion 212 on the inner sheath assembly 21 through the connecting lug, and in the above-mentioned half release position, the connecting lug and the engagement portion are always wrapped by the distal end of the outer sheath 22.

In addition, in the semi-release position, according to the release sequence of the interventional instruments, the proximal end position of the interventional instruments can be restrained, and the distal end position of the interventional instruments can be restrained (namely, the proximal end is released first).

In fact, during the movement of the outer sheath 22 relative to the inner sheath assembly 21, an operator may need to prompt a plurality of the above-mentioned relative positions, that is, a first relative position and a second relative position exist in sequence along the axial direction, and the prompt assembly may respectively respond to the two relative positions and directly feed back to the operator.

Referring to fig. 9a, in the first relative position (i.e., the initial position), the position of the outer sheath 22 is denoted as P1, and the position of the follower 41 that is interlocked with the outer sheath 22 is denoted as P2.

Referring to fig. 9c, when the outer sheath is in the fully exposed loading position, i.e., the released position, the position of the outer sheath 22 is designated as P1", and the position of the follower 41 is designated as P2".

Referring to fig. 9b, the second relative position is between the first relative position and the release position, where the position of the outer sheath 22 is denoted as P1 'and the position of the follower 41 is denoted as P2'.

With respect to the inner sheath assembly 21, the total travel of the outer sheath 22 is M1 (i.e., the distance between P1 and P1 "), and since the outer sheath 22 and the follower 41 are interlocked, the total travel of the follower 41 is also M1. The outer sheath has a travel distance M2 (i.e., the distance between P1 and P1') between the first and second relative positions, and M2 is at least 1/3 of M1.

Preferably, the prosthetic heart valve described above is released to a predetermined procedure when the outer sheath 22 and inner sheath assembly 21 are in a semi-released position.

Based on the above-mentioned practical requirements, the present application sets 2 sets of prompting latches corresponding to the fully retracted position (the first relative position) and the half released position (the second relative position) of the interventional device respectively, and when the first elastic member 7 abuts against the first set of prompting latches 60a (as shown in fig. 10), the outer sheath 22 connected to the movable seat 41a completely accommodates the interventional device, and at this time, prompts the operator that the outer sheath cannot be driven distally any more.

The second set of prompting latches 60b is located at the proximal end side of the first set of prompting latches 60a, when the first elastic member abuts against the second set of prompting latches 60b (as shown in fig. 11), the outer sheath connected to the movable seat semi-releases the interventional instrument, that is, the proximal end of the interventional instrument is not completely released from the delivery system, for example, in the semi-release position, the engagement portion 212 between the connecting lug of the interventional instrument and the inner sheath assembly 21 is still wrapped by the distal end of the outer sheath, and at this time, if the interventional instrument needs to be recovered, the outer sheath can be pushed to the distal end.

And once the outer sheath tube moves proximally beyond the half-release position, the interventional instrument is completely exposed and released, and the interventional instrument cannot be recovered by pushing the outer sheath tube, so that the half-release position should be necessary for an operator when the interventional instrument is released.

If the operator considers that the position or the posture of the interventional instrument does not reach the preset state in the half-release position, the operator can rotate the driving sleeve to slide the outer sheath tube distally, and the outer sheath tube is restored to the initial position of the loading position of the wrapping of the outer sheath tube.

No matter retrieve, or after intervention apparatus is correctly released, all need to push outer sheath pipe to the distal end, when first elastic component 7 offsets with this first group suggestion latch, the outer sheath pipe 22 that the follower is connected accomodates intervention apparatus completely, and suggestion operator can no longer drive outer sheath pipe to the distal end this moment, avoids outer sheath pipe excessive extrusion to lead the deformation of head rear end to cause the potential safety hazard.

Regarding the structural design of the driving sleeve, the driving sleeve 42a may have a single-layer structure or a double-layer structure, wherein the single-layer structure has an internal thread capable of engaging with the driving teeth 412, and a space capable of fixing the indicating teeth 60 may be suitable for the above-mentioned embodiments.

For easy processing and assembly, as shown in fig. 12, the driving member 42 may also adopt a double-layer structure with a bushing 423 and a housing 424, and a rotation stopping structure is disposed between the housing 424 and the bushing 423, so that the housing 424 is fixedly sleeved on the periphery of the bushing 423, and the rotation stopping structure includes at least one of the following modes:

A limit groove located on one of the inner wall of the housing 424 and the outer wall of the bushing 423;

and the limit rib is positioned on the other of the inner wall of the shell 424 and the outer wall of the bushing 423.

The side wall of the bushing 423 is provided with a containing hole 4231, the indicating latch 60 is positioned in the corresponding containing hole 4231, and the inner wall of the bushing 423 is provided with an internal thread 422 in transmission fit with the driven member 41.

Further, since the sidewall of the bushing 423 is provided with the receiving hole 4231 for placing the indicator tooth 60, in order to prevent the operator from directly touching the indicator tooth by mistake, the housing 424 in the double-layer structure of the driving sleeve covers the receiving hole 4231.

Because the structure of the indicating latch and the bushing is complex, if the two are integrally formed, the manufacturing process is too complex, and the production cost is increased, so that the indicating latch 60 and the bushing 423 are in a split fixing structure in the application, and the indicating latch 60 can be understood to be fixed on the bushing 423 in a manner known in the art.

Preferably, a limiting step 4232 is provided at the inner edge of the accommodating hole 4231, and the edge of the indicating latch 60 is fixedly mounted on the limiting step 4232, and then can be fixed by matching with bonding or the like according to the need. The stop block 4232 may be part of the thread of the internal thread 422, thereby eliminating the need for additional machining steps.

The prompting latch 60 and the first elastic member 7 are not limited to a time point when being matched, and preferably correspond to a section of rotation range of the driving sleeve, in the process, the prompting latch 60 can be prompted for a plurality of times, so that an operator is ensured to know, and the prompting latch 60 has corresponding extension lengths in the axial direction and the circumferential direction of the supporting body. As the cooperation accommodation hole 4231 is the bar hole, and the shape is corresponding with suggestion latch 60, and the extending direction of bar hole self is unanimous with the screw angle of internal thread, can adapt to the axial motion component of follower just, guarantees suggestion latch 60 and first elastic component 7 in the cooperation in-process a lot of, the suggestion of effect stability.

In order to further ensure the stability of the threaded transmission fit between the driving sleeve 42a and the movable seat 41a, as shown in fig. 13, the first handle 30 at least includes a support body 32, the support body 32 is provided with a guide groove 321 extending along the axial direction, the movable seat 41a is slidably engaged with the support body 32 through the guide groove 321, the driving sleeve 42a is rotatably mounted on the periphery of the support body 32, and the guide groove 321 plays a role in limiting the circumferential rotation of the movable seat, so that the movable seat can only slide along the axial direction.

The first elastic member is an important component that cooperates with the prompting latch and generates an acoustic prompting effect, and in order to better fix the first elastic member, the movable seat 41a of the present application includes a seat 413, at least a portion of the seat 413 is a sliding portion 4131 located inside the support 32, the driving tooth 412 is fixed on the sliding portion 4131, the first elastic member 7 may be directly or indirectly connected to the sliding portion 4131, and the first elastic member 7 may also be indirectly connected to the driving tooth 412.

The following provides an improved way of indirectly connecting the first elastic member 7 to the sliding portion 4131, as in the figures, the first elastic member 7 is fixed to the sliding portion 4131 via the intermediate member 8, and the intermediate member 8 is located outside the supporting body 32, so that the installation of the intermediate member 8 is not limited to the narrow space between the sliding portion 4131 and the supporting body 32, and the structural stability is further enhanced by utilizing the larger space outside the supporting body 32.

The intermediate member 8 is provided with a positioning hole 81, and is sleeved and fixed to the transmission gear 412 through the positioning hole 81, so that the intermediate member 8 moves synchronously along with the transmission gear 412, namely, the aim of linking the first elastic member 7 and the sliding part 4131 is fulfilled.

The middle piece 8 is cylindrical and is sleeved on the periphery of the supporting body 32 in a sliding manner, so that the inner wall of the middle piece 8 is better attached to the supporting body 32.

In order to further enhance the elasticity and structural strength of the first elastic member, the first elastic member 7 is a bridge arm 72 with two ends fixed to the intermediate member 8, and since the bridge arm 72 has a large elastic deformation amount, the middle area of the bridge arm 72 is matched with the prompting latch, and the prompting latch can smoothly pass over the first elastic member 7.

Because the arrangement direction of the arc-shaped prompting latch is consistent with the thread angle of the internal thread, in order to enable the matching of the bridge arm and the prompting latch to be smoother, the extending angle of the bridge arm 72 in the length direction is also consistent with the thread angle of the internal thread.

The middle area of the bridge arm 72 is provided with a protrusion 71 which is matched with the prompting latch, more specifically, the convex tooth 62 on the prompting latch is matched with the protrusion 71, so that the deformation amount of the first elastic element 7 when the prompting latch passes over the first elastic element 7 can be controlled within the minimum range.

In the above operation, the limiting of the relative sliding limit position of the first handle and the second handle by the two sets of locking mechanisms independently configured in the control handle may be understood as limiting the movement distance of the second handle during the process that the second handle 9 directly drives the inner sheath assembly 21 to move proximally, or may be understood as limiting the sliding distance of the second handle relative to the first handle. Some embodiments below also provide improvements to the locking mechanism in combination with the tube quick-withdraw function, such as the mentioned catheter assembly and first and second handles, which may be combined with the embodiments above.

During the release process, the operator holds the first handle all the time, and directly drives the inner sheath assembly 21 to move proximally by using the second handle 9 as follows:

when the interventional instrument 1 is released, the initial relative positions of the first handle 30 and the second handle 9 are locked at the first position, and an operator can only drive the first handle 30 (a rotatable driving sleeve enables the movable seat to axially slide) to drive the outer sheath 22 to slide proximally and expose the loading position until the release is completed;

When the interventional device 1 is released, the operator needs to move the inner sheath assembly 21 proximally and restore the inner sheath assembly to a state suitable for in-vivo navigation, at this time, the first locking mechanism 91 is unlocked, the second handle 9 is directly driven, the first handle 30 and the second handle 9 are switched to the second position, the outer sheath 22 is covered on the loading position, the catheter assembly is restored to the navigation state, finally the operator holds the whole control handle, and synchronously moves the first handle 30 and the second handle 9, so that all the pipe fittings are withdrawn from the body.

Compared with the single thread driving mode of the catheter assembly in the prior art, the application introduces a new retraction mode based on the existing single thread retraction mode, assists the proximal retraction stage of the inner sheath assembly 21, can realize the rapid proximal retraction of the inner sheath assembly 21, and enables the outer sheath 22 and the inner sheath assembly 21 to rapidly recover to a state suitable for in-vivo passing. In addition, after the second handle is quickly withdrawn a predetermined distance, the second locking mechanism 92 maintains the first and second handles in the current relative position, and all the tubes are simultaneously driven out of the body by the entire control handle. The quick retraction of the inner sheath assembly 21 also improves the adjustment efficiency of the relative position between the pipe fittings, and achieves more control effect and operation experience.

When the second position is switched between the first handle 30 and the second handle 9, the first handle and the second handle can only slide along the axial direction, and a rotation stopping structure is arranged between the first handle and the second handle, so that relative circumferential rotation cannot be performed.

Referring to fig. 15 to 18, the second handle 9 includes a second housing 901 and a pipe joint 902 fixed in the second housing 901. The tube joint 902 is used for abutting with the proximal end of the controlled tube (i.e. the inner sheath assembly 21), the tube joint 902 is connected with the extension sleeve 93, the proximal end of the extension sleeve 93 can be fixedly connected to the tube joint 902 through the clamping structure 933, and the interior of the extension sleeve 93 is a threading channel of the inner sheath assembly 21.

Wherein, the proximal end of the extension sleeve 93 and the interior of the first handle 30 are provided with mutually matched anti-disengaging structures 932, limiting the limit position of the extension sleeve 93 moving proximally, preventing the extension sleeve from excessively sliding proximally and even disengaging from the first handle, the anti-disengaging structures 932 can be clamped, inserted, lapped and the like, and an improved mode is provided below.

Preferably, the anti-disengaging structure 932 includes an outer protruding portion 9321 and a stopping portion 9322, wherein the outer protruding portion 9321 is located at a proximal end of the extending sleeve 93 and protrudes radially from the extending sleeve 93, the stopping portion 9322 is located inside the first handle 30, and the stopping portion 9322 is distributed on an outer periphery of the outer protruding portion 9321 and keeps off, so as to limit the outer protruding portion 9321 to move further proximally.

In addition, the extension sleeve is provided with a rib 934, and the stop portion 9322 is provided with a limit groove matched with the rib 934, and has the function of preventing the second handle from rotating in the movement process, and the rotation stopping structure between the first handle and the second handle is the matched rib 934 and limit groove.

In the first position, the proximal end of the first handle 30 acts as a connecting section 35 and extends into the distal end of the second housing 901, and the first locking mechanism 91 acts on the connecting section 35 to form a locked condition in which the two cooperate and a released condition in which the two are disengaged.

The second locking mechanism and the extension sleeve can be matched by adopting a clamping structure and a locking structure, so that the first handle and the second handle are kept at the second position.

Both sets of locking mechanisms comprise a state assembly and a limiting member, wherein the limiting member is preferably in an annular structure, sleeved and radially slidably mounted on one of the first handle 30 and the second handle 9, the inner edge of the annular structure is used as a locking member matched with the other of the two handles, for example, raised ribs can be arranged on the inner edge of the annular structure as the locking member, and the locking member is propped against the corresponding handle or stretches into a hole or groove and other structures on the corresponding handle, so that the corresponding handle is locked. The state assembly can apply a restoring force to two opposite radial sides of the limiting piece, and is used for keeping the limiting piece in a locking state and switching to a locking releasing state. The annular structure not only fully utilizes the internal clearance between the first handle and the second handle, but also ensures that the limiting piece has enough structural strength.

In the first locking mechanism 91, the limiting member is a first limiting member 911 movably mounted in the second housing 901 and located at the outer periphery of the connecting section 35 at the first position, the outer wall of the connecting section 35 is provided with a first locking groove 351 matched with the first limiting member 911, the state assembly comprises a second elastic member 912 and a control button 913, the second elastic member 912 acts between the second housing 901 and the first limiting member 911 to drive the first limiting member 911 to enter a locking state, the control button 913 is movably embedded in the second housing 901, and the control button 913 is linked with the first limiting member 911 to drive the first limiting member 911 to enter a unlocking state.

In the first position, the first locking mechanism 91 acts on the connection section 35, that is, the first limiting member 911 has a locking state in which the first limiting member 911 is engaged with the connection section 35 and limits the second housing 901 from being axially separated from the first handle 30, and a releasing state in which the first limiting member 911 is separated from the connection section 35, so that an operator can move the second handle 9 further proximally relative to the first handle 30, directly drive the inner sheath assembly 21, and realize rapid proximal withdrawal of the inner sheath assembly 21 while pulling the second handle 9, because no transmission member such as screw threads, gears, or the like is required.

The second elastic member 912 acts on the first limiting member 911 to drive the first limiting member 911 to maintain in the locked state, so that the initial state of the first limiting member 911 is the locked state (the safety can be improved) under the condition that no external force is applied, and the operator only needs to overcome the elastic force of the second elastic member 912 when the operator needs to switch the first limiting member 911 to the unlocked state.

The control button 913 is linked with the first limiting member 911 to drive the first limiting member 911 to be in a releasing state, and an operator directly applies a force to the control button 913 to switch the state of the first limiting member 911.

Regarding the specific structure of the first locking mechanism, the first limiting member 911 is in an annular structure and is sleeved on the outer periphery of the connecting section 35, the second elastic member 912 and the control knob 913 act on two opposite radial sides of the first limiting member 911, the outer wall of the connecting section 35 is provided with a first locking groove 351 matched with the first limiting member 911, and the first limiting member 911 is clamped into the first locking groove 351 to axially limit in the locked state.

The first lock 9111 is provided on the inner edge of the annular structure of the first stopper 911, and is engaged with the first locking groove 351, whereby the locked state is stabilized by the engagement of the first lock 9111 and the first locking groove 351.

The second casing 901 is provided with a guide groove 9011, at least a part of the first limiting piece 911 is slidably matched with the guide groove 9011, and stability of a movement path of the first limiting piece 911 and smoothness of state switching are further guaranteed.

The two opposite sides of the connecting section 35 are respectively provided with a first locking groove 351, the first locking grooves 351 on the two opposite sides are arranged in a staggered manner along the axial direction, the first locking mechanisms (the first locking mechanism 91a and the first locking mechanism 91 b) are two sets, the first limiting pieces (the first limiting piece 911a and the first limiting piece 911 b) in the two sets are overlapped side by side along the axial direction, and the first locking piece 9111 in each first limiting piece is matched with the first locking groove 351 on the corresponding side of the connecting section 35. The two sets of first limiting parts overlapped side by side lock the connecting sections 35 from two opposite sides, and the force application is more uniform, so that the locking effect is ensured.

The second elastic members (second elastic member 912a, second elastic member 912 b) and the control buttons (control buttons 913a, 913 b) in the two sets are mirror image distributed and correspond to the respective first limiting members (first limiting member 911a, first limiting member 911 b). One end of the second elastic member in each set abuts against the first limiting member in the set, and the other end abuts against the control button in the other set, as in the figure, one end of the second elastic member 912a abuts against one end of the first limiting member 911a, the other end of the first limiting member 911a abuts against the control button 913a, and the other end of the second elastic member 912a abuts against the control button 913 b.

Control button 913a and control button 913b may be pressed simultaneously in opposite directions by one hand during operation; the corresponding first stop 911a and the first stop 911b are synchronously unlocked.

In order to make the control button more stable for transmitting the acting force, the control button 913 is provided with two positioning structures at one side facing the inner body, namely a first receiving groove 9131 which is positioned against the first limiting member in the sleeve and a second receiving groove 9132 which is positioned against the second elastic member in the other sleeve, so that the abutting ends of the first limiting member and the second elastic member are limited at fixed positions.

In order to make the moving path of the first limiting member more stable, positioning posts are set on two opposite sides of the first limiting member, which are respectively a first positioning post 9112 extending into the corresponding first receiving slot 9131 and a second positioning post 9113 extending into the corresponding second elastic member 912 for sleeving.

The second housing 901 is provided with a hollowed-out area 9012, a part of the control button 913 is exposed and protrudes outside the hollowed-out area 9012, the edge of the control button 913 is provided with an anti-drop edge 9133 in the second housing 901, and the anti-drop edge 9133 is limited by the inner edge of the hollowed-out area 9012.

The inner edge of the hollowed-out area 9012 is annularly provided with a reinforcing seat 9013 extending into the second shell, the reinforcing seat 9013 is provided with a stabilizing groove 9014, and at least a part of the anti-falling edge 9133 extends into the stabilizing groove 9014, so that the control button 913 is stably fixed in the hollowed-out area 9012 and does not shake.

The first receiving groove 9131 and the second receiving groove 9132 are sequentially arranged along the axial direction, and since a gap exists between the second receiving groove 9132 and one end of the second elastic member, the anti-falling edge 9133 is provided with a lug 9134 matched with the stabilizing groove 9014 on the side adjacent to the second receiving groove 9132, so that slight shaking is prevented from occurring on the side of the second receiving groove 9132 of the control knob 913.

In the second locking mechanism 92, the limiting member is a second limiting member 921 sleeved on the outer periphery of the extension sleeve, the inner edge of the second limiting member 921 is provided with a second locking member 9211, the outer periphery of the extension sleeve 93 is provided with a second locking groove 931, and the second locking groove 931 is matched with the second locking member 9211; the state assembly comprises a spring 922 and an unlocking button 923, wherein the spring 922 acts between the first handle 30 and the second limiting piece 921 to drive the second limiting piece 921 to enter a locking state, and the unlocking button 923 is fixed on the second limiting piece 921 to drive the second limiting piece 921 to enter a unlocking state.

Regarding the fitting structure of the extension sleeve and the second locking mechanism, the second locking groove 931 is provided on the outer periphery of the extension sleeve 93, and the second locking mechanism 92 includes a second stopper 921 fitted around the outer periphery of the extension sleeve 93, a spring 922 acting between the first handle 30 and the second stopper 921, and an unlocking knob 923 fixed to the second stopper 921. The second limiting piece 921 is in an annular structure, the second locking piece 9211 matched with the second locking groove 931 is arranged on the inner edge of the second limiting piece 921, the second limiting piece 921 is in a locking state matched with the extension sleeve 93 and a releasing state for releasing the matching, the spring 922 drives the second limiting piece 921 to enter the locking state, and the unlocking button 923 drives the second limiting piece 921 to enter the releasing state.

The connection section 35 is a hollow structure for extending the controlled pipe, the second limiting member 921 is located inside the connection section 35, and the unlocking knob 923 penetrates through and is exposed to the side wall of the connection section 35, so that an operator can directly apply a force to the unlocking knob 923.

When the second handle 9 is in the first position, the second housing 901 covers Jie Suoniu 923, preventing the operator from touching by mistake. When the second handle 9 is in the second position, the unlocking button 923 is exposed to the second housing 901, and the operator can directly press the unlocking button 923 to drive the second limiting member 921 into the unlocking state.

The spring 922 and the unlocking knob 923 are located at opposite sides of the second limiting member 921, so that an operator can apply a force directly to the second limiting member 921 through the unlocking knob 923, enhancing unlocking efficiency.

Because the spring is easy to shift in the moving process, a guide post 9212 is further arranged on one side of the second limiting piece 921, which is opposite to the unlocking button 923, the spring 922 is sleeved on the guide post 9212, and the guide post 9212 also movably penetrates into the side wall of the connecting section 35, so that the axial direction of the spring is guided, and the spring is prevented from deviating from a preset position.

In the moving process of the outer sheath tube relative to the first handle, when the outer sheath tube reaches a proper position, the outer sheath tube is generally required to be locked, the driving sleeve is limited in a common locking mode, and when the sheath core assembly is quickly retracted, the relative fixation of the outer sheath tube and the first handle and the limiting of the driving sleeve are also required to be ensured. Some of the embodiments below are modifications to the drive sleeve locking function that may be combined with other embodiments of the application, such as the first handle and drive sleeve mentioned, may be combined with the embodiments described above.

Referring to fig. 19 to 25, in order to facilitate the operator to lock the driving sleeve 42a and prevent the erroneous rotation, a part of the first handle 30 is a locking portion 31 at the outer periphery of the driving sleeve 42a, and at least a part of the locking portion 31 is a radially deformable urging portion 311, and the urging portion 311 has a locked state in which it acts with the driving sleeve 42a to restrict the rotation of the driving sleeve 42a, and an unlocked state in which it releases the restriction.

The locking part 31 is sleeved outside the driving sleeve 42a and is coaxial with the driving sleeve 42a, a fit clearance exists between the locking part 31 and the driving sleeve 42a, and the fit clearance serves as a deformation space of the force application part 311. The urging portion 311 is radially deformed in the direction of the central axis by the radial force, so that the urging portion 311 can be inserted into the fit clearance and abutted against the outer wall of the drive sleeve 42a, thereby entering a locked state in which the rotation of the drive sleeve 42a is restricted. When the radial force is withdrawn, the force application portion 311 is reset and exits the fit clearance, and the lock release state is achieved after the restriction is released.

The urging portion 311 is an important part for switching the locked state of the driving sleeve 42a, and the lock portion 31 of the present application has a cylindrical structure 313 to improve the coaxiality with the driving sleeve 42a in order to secure the locking effect of the driving sleeve 42 a. One part of the side wall of the tubular structure 313 also serves as the urging portion 311, and the urging portion 311 is integrally formed with the tubular structure 313, so that the overall structure can be greatly simplified, and the assembly process can be reduced. The hollow area 3131 for releasing deformation is provided between the force applying portion 311 and the peripheral portion, the hollow area 3131 surrounds the periphery of the force applying portion 311, and a space is reserved for radial deformation of the force applying portion 311, but in order to ensure the overall strength of the tubular structure 313, the area of the hollow area 3131 should not be too large.

The force application parts 311 are multiple and distributed at intervals along the circumferential direction of the cylindrical structure 313, so that the force bearing area of the driving sleeve 42a is increased, the force bearing of the driving sleeve 42a is balanced, and the locking effect is enhanced.

The urging portion 311 has a span of at least 1/6 of the circumference in the circumferential direction of the tubular structure 313, and can achieve both good locking effect and sufficient structural strength.

The inner side of the urging portion 311 is provided with first anti-slip teeth 3111 in the radial direction of the lock portion 31. After the force application portion 311 is deformed by radial force, the contact area of the first anti-slip tooth 3111 can be greatly increased, friction force is increased, and locking effect is enhanced as compared with the force application portion with smooth inner side.

In consideration of inconvenience of operators in directly applying radial force to the force applying part, the application is provided with the operation ring 312 in a rotating sleeve at the outer periphery of the locking part 31, the inner wall of the operation ring 312 is provided with the working part 3121 which is radially inwards convex and matched with the force applying part 311, and the working part 3121 moves along with the operation ring 312 to switch the state of the force applying part 311.

Since there is a fit gap between the locking portion 31 and the driving sleeve 42a, if the force application portion 311 directly locks the driving sleeve 42a, not only the force application portion 311 needs to pass through the fit gap, but also only the head region of the force application portion 311 can be in contact with the driving sleeve 42a, and the contact area between the two is always limited, so that a part of the driving sleeve 42a is used as a plugging section 421 matched with the locking portion 31, an elastic locking ring 5 is sleeved on the outer periphery of the plugging section 421, and the force application portion 311 abuts against the elastic locking ring 5 and limits the rotation of the driving sleeve 42a when the driving sleeve 42a is in a locked state. The elastic locking ring 5 is used for filling the fit gap between the locking portion 31 and the driving sleeve 42a, so that the force application portion 311 can press the plugging section 421 through the elastic locking ring 5 only by small radial deformation, thereby saving labor and having excellent locking effect.

The elastic locking ring 5 can be made of high-elasticity materials such as rubber, silica gel and nylon, and can not only prevent slipping but also provide good hand feeling and damping effect through deformation of the elastic locking ring.

In order to further enhance the locking effect of the elastic locking ring 5 and the plug section 421, an anti-slip structure is provided between the elastic locking ring 5 and the plug section 421, the anti-slip structure comprising at least one of the following means:

the second anti-slip teeth 51 are distributed on the inner wall of the elastic locking ring 5;

the third anti-slip teeth 4211 are distributed on the outer wall of the plug section 421.

The second anti-slip tooth 51 and the third anti-slip tooth 4211 can increase the friction force between the elastic locking ring 5 and the plug section 421, and further enhance the locking effect on the driving sleeve.

Preferably, the second anti-slip tooth 51 and the third anti-slip tooth 4211 are engaged with each other, so that the elastic locking ring 5 and the plug section 421 hardly slide relatively in the abutting process, the locking efficiency is very high, and the locking effect on the driving sleeve is further enhanced.

Regarding the axial limiting problem of the elastic locking ring 5, the distal end side of the plugging section 421 is provided with a limiting flange 4212, and the proximal end side is provided with a limiting ring 4213, so that the elastic locking ring 5 is limited on the section of the plugging section 421 with the anti-slip structure, the elastic locking ring 5 is prevented from being separated in the operation process, and the locking effect is further ensured.

In order to further increase the operation effect and experience, referring to fig. 23, the operation ring 312 of the present application converts the rotation force of the operator into the radial force to the force application portion 311, so that the operation effect is more flexible and the operation experience is better. The outer wall of the operating ring 312 is provided with radially outwardly protruding protrusions 3122 such that the operator applies a rotational force directly to the protrusions 3122, the protrusions 3122 enabling a more concentrated and more effort-saving area for the operator than having the operator directly press the outer wall plane of the operating ring 312.

The force application portions 311 are one or a plurality of force application portions 31 are circumferentially arranged at intervals, the inner wall of the operation ring 312 is circumferentially alternately provided with concave regions 3124 and inner convex regions 3123 serving as working portions, as in the figure, the concave regions 3124 are used for accommodating the force application portions 311 when deformation does not occur in the inner wall structure of the operation ring 312 corresponding to the number of the force application portions 311 being 2, and the highest point of the inner convex regions 3123 in the radial direction is lower than the highest point of the force application portions 311 relative to the concave regions 3124, and the inner convex regions 3123 are closer to the central axis in the radial direction.

In the locked state, the outer side of the urging portion 311 abuts against the inner convex portion 3123, so that the inner convex portion 3123 compresses and deforms the urging portion 311 in the radial direction, and the urging portion 311 restricts the rotation of the drive sleeve 42 a.

In the lock release state, the outer side of the urging portion 311 corresponds to the concave region 3124, and the concave region 3124 reserves a sufficient space for accommodating the urging portion 311, thereby holding the urging portion 311 in the reset state.

The concave area 3124 and the inner convex area 3123 are connected through slope transition, so that the whole inner wall structure of the operation ring 312 is a smooth arc surface, and the condition that the force application part 311 is blocked or the like can not occur in the rotation process of the operation ring 312 is ensured.

Referring to fig. 24 and 25, in order to better fit the first handle with the movable seat 41a and the driving sleeve 42a, the first handle 30 of the present application has a three-layer assembly structure including a support 32, an intermediate sleeve 33, and a first housing 34. The support body 32 mainly plays a role of fixedly supporting each component, and as shown in the drawing, the movable seat 41a is slidably mounted in the support body 32, and the driving sleeve 42a is rotatably mounted on the outer periphery of the support body 32.

The middle sleeve 33 has the functions of fixing, supporting and limiting the locking driving sleeve 42a, wherein the far end of the supporting body 32 is fixed on the middle sleeve 33 through a clamping structure known in the art, and the near end side of the middle sleeve 33 is positioned on the periphery of the supporting body 32 and is used as a locking part 31, so that the parts of the control handle are reduced, and the structure is simplified.

The first housing 34 is used for covering the internal structure and connecting and fixing other internal parts, wherein the first housing 34 is wrapped and fixed on the outer periphery of the middle sleeve 33 through a clamping structure known in the art, a first gap is formed between the first housing and the radial direction of the locking part 31, and the operating ring 312 is rotatably installed in the first gap, at least one part of the operating ring is exposed to the first housing 34, so that an operator can directly rotate the operating ring 312.

In addition, a second gap is formed between the supporting body 32 and the locking portion 31 in the radial direction, and the plugging section 421 on the distal end side of the driving sleeve 42a extends into the second gap, so that the assembly accuracy of the plugging section 421 and the locking portion 31 is further ensured.

In order to intuitively reflect the operation progress of the interventional instrument on the control handle, the visual structure is added to the first shell 34, in the figure, the first shell 34 is provided with the indication window 341 extending along the axial direction, one side of the far end of the movable seat 41a is provided with the travel indication element 411, the travel indication element 411 can slide along the indication window 341, and the far end and the near end of the indication window 341 respectively correspond to the limit positions of the movable seat 41a sliding towards the far end and the near end, so that an operator can directly observe the position of the travel indication element 411 to prejudge the operation progress of the interventional instrument, and the operation progress visualization is realized.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description. When technical features of different embodiments are embodied in the same drawing, the drawing can be regarded as a combination of the embodiments concerned also being disclosed at the same time.

The above examples illustrate only a few embodiments of the application, which are described in detail and are not to be construed as limiting the scope of the claims. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the application, which are all within the scope of the application.

Claims

1. A prosthetic heart valve delivery system, comprising:

an interventional delivery system having opposed distal and proximal ends and an axial direction extending therebetween, the delivery system comprising a catheter assembly and a control handle connected to the proximal end of the catheter assembly, the catheter assembly comprising an inner sheath assembly and an outer sheath, a radial gap at the distal ends of both the inner sheath assembly and the outer sheath being a loading site for receiving a prosthetic heart valve, the inner sheath assembly and the outer sheath being configured for relative movement such that the outer sheath encases or exposes the loading site;

the prosthetic heart valve is releasably coupled to the loading site;

the utility model is characterized in that the control handle comprises:

The first handle is used for being connected with the outer sheath tube, and a prompt component is arranged in the first handle;

a second handle slidably coupled to the first handle, the second handle being positioned on a proximal side of the first handle and adapted to be coupled to the inner sheath tube assembly, the second handle having a first position coupled to the first handle and a second position slid proximally a predetermined distance;

a first locking mechanism mounted to the second handle and cooperating with a proximal portion of the first handle to retain the second handle in a first position;

the second locking mechanism is arranged on the first handle and matched with the extension sleeve to keep the second handle at a second position, and the second locking mechanism is hidden on the inner side of the second handle when in the first position;

the first handle and the second handle are configured to:

maintaining the second handle in a first position by the first locking mechanism, the first handle controlling the proximal sliding of the outer sheath relative to the inner sheath assembly to expose the outer sheath to the loading position, the cue assembly providing a tactile and/or audible response in a vibratory manner when the outer sheath is slid proximally relative to the inner sheath assembly to a predetermined progression;

Unlocking the first locking mechanism, controlling the inner sheath assembly to slide proximally relative to the outer sheath by the second handle, such that the outer sheath encloses the loading site, and the second locking mechanism holds the second handle in a second position;

the prompting component comprises a prompting latch and an elastic piece, a movable seat connected with the outer sheath tube is axially and slidably arranged on the first handle, the movable seat is connected with the outer sheath tube, and the elastic piece is arranged on the movable seat;

the first handle is also rotatably provided with a driving sleeve, the driving sleeve is provided with internal threads and is arranged on the periphery of the movable seat, the movable seat is provided with transmission teeth matched with the internal threads, and the prompting latch is arranged on the driving sleeve;

the elastic piece and the prompting latch are propped against each other in a state of opposite positions, and the deformation of the elastic piece at least allows the prompting latch to rotate along with the driving sleeve and pass over the elastic piece;

the indicator latch is responsive to the inner sheath assembly and the outer sheath at different relative positions, respectively.

2. The prosthetic heart valve delivery system of claim 1,

The inner sheath tube assembly and the outer sheath tube are provided with:

a first relative position, the outer sheath surrounding the loading site;

a second relative position, wherein the outer sheath exposes a portion of the loading position, and the outer sheath is slid proximally relative to the inner sheath assembly to a predetermined progression.

3. The prosthetic heart valve delivery system of claim 2, wherein the indicator latch comprises two sets, one set of indicator latches and the elastic member being responsive in the first relative position and the other set of indicator latches and the elastic member being responsive in the second relative position.

4. The prosthetic heart valve delivery system of claim 2, wherein the first handle comprises at least a support body that is in sliding engagement with the movable seat, the movable seat comprising:

the transmission teeth are fixed on the sliding part;

the elastic piece is fixed to the sliding part through the middle piece, the middle piece is located outside the supporting body, the elastic piece is a bridge arm with two ends fixed to the middle piece, and the middle area of the bridge arm is matched with the prompting latch.

5. The prosthetic heart valve delivery system of claim 1, wherein the second handle comprises:

the first locking mechanism includes:

the elastic piece acts between the second shell and the first limiting piece to drive the first limiting piece to enter a locking state;

when the first locking mechanism is unlocked, the control button is operated.

6. The prosthetic heart valve delivery system of claim 5, wherein the first locking mechanism comprises two sets, first stop members of the two sets being stacked side-by-side along the axial direction, the first locking member of each first stop member cooperating with the first locking groove on the corresponding side of the connecting segment;

The elastic pieces and the control buttons in the two sets are distributed in a mirror image mode; one end of the elastic piece in each sleeve is propped against the first limiting piece in the sleeve, and the other end of the elastic piece in each sleeve is propped against the control button in the other sleeve;

7. The prosthetic heart valve delivery system of claim 5, wherein the second locking mechanism comprises:

the second limiting piece is sleeved on the periphery of the extension sleeve, a second locking groove matched with the second limiting piece is formed in the periphery of the extension sleeve, a second locking piece matched with the second locking groove is arranged at the inner edge of the second limiting piece, and the second limiting piece has a locking state matched with the extension sleeve and a releasing state for releasing the matching; the second limiting piece is positioned in the connecting section, the unlocking button penetrates through and is exposed to the side wall of the connecting section, the first handle and the second handle are positioned at the first position, and the second shell covers the unlocking button; the first handle and the second handle are in a second position, and the unlocking button is exposed to the second shell;