CN116172755B

CN116172755B - Interventional instrument delivery system with locking structure

Info

Publication number: CN116172755B
Application number: CN202310473292.XA
Authority: CN
Inventors: 张志飞; 罗建方; 李捷; 曾桂容; 刘伟伟; 马甜; 刘兆刚; 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: 2023-04-28
Publication date: 2023-08-15
Anticipated expiration: 2043-04-28
Also published as: CN116172756B; CN116172755A; CN116172756A

Abstract

The application discloses an interventional instrument conveying system with a locking structure, which comprises a catheter assembly and a control handle, wherein the catheter assembly comprises an inner sheath tube assembly and an outer sheath tube which can move relatively; the control handle comprises a first handle and a plurality of sets of driving mechanisms, wherein one set of driving mechanism comprises: one part of the driving sleeve is an inserting section; a locking part of which one part is matched with the plug-in section, wherein at least one part of the locking part is a force application part, and the force application part is provided with a locking state and a releasing state for releasing the restriction; an elastic locking ring; the outer periphery of the locking part is rotatably sleeved with an operation ring, the inner wall of the operation ring is provided with a radially inward protruding working part, the working part is matched with the force application part, and the working part moves along with the operation ring to switch the state of the force application part. The application can lock the corresponding pipe fitting rapidly, and can achieve better control effect in the aspects of operation functions such as conveying, releasing, recovering and the like of the interventional instrument.

Description

Interventional instrument delivery system with locking structure

Technical Field

The present application relates to the field of medical devices, and in particular to an interventional instrument delivery system with a locking structure.

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.

In the prior art, the locking structure of the conveying system is generally a clamping groove and a movable component which are matched, but the relative positions of the movable component and the clamping groove are dislocated in the locking process, for example, the movable component can be abutted against the groove wall, and the relative positions need to be further shifted to enter the locking state. Therefore, the locking structure cannot be locked at any position accurately, and the accuracy is limited by the number and the density of the clamping grooves.

Disclosure of Invention

In order to solve the technical problems, the application discloses an interventional instrument conveying system with a locking structure, which is provided with a far end, a near end and an axial direction extending between the far end and the near end, wherein the interventional instrument conveying system comprises a catheter assembly and a control handle connected with the near end of the catheter assembly, the catheter assembly comprises an inner sheath tube assembly and an outer sheath tube, a radial gap between the far ends of the inner sheath tube assembly and the outer sheath tube is a loading position for containing an interventional instrument, and the inner sheath tube assembly and the outer sheath tube are configured to be capable of relatively moving so that the outer sheath tube covers or exposes the loading position;

The control handle comprises a first handle and a plurality of sets of driving mechanisms, and each set of driving mechanism is in transmission fit with a corresponding pipe fitting in the catheter assembly;

one set of driving mechanism comprises:

the driving sleeve is rotatably arranged on the first handle, and one part of the driving sleeve is an inserting section;

one part of the first handle is a locking part which is arranged on the periphery of the driving sleeve and matched with the inserting section, at least one part of the locking part is a radially deformable force application part, and the force application part is provided with a locking state which acts with the driving sleeve and limits the rotation of the driving sleeve and a releasing state which releases the limitation;

the elastic locking ring is sleeved on the periphery of the inserting section, and in the locking state, the force application part abuts against the elastic locking ring and limits the rotation of the driving sleeve;

the outer periphery of the locking part is rotatably sleeved with an operation ring, the inner wall of the operation ring is provided with a radially inwards protruding working part, the working part is matched with the force application part, and the working part moves along with the operation ring to switch the state of the force application part.

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, the driving mechanism further comprises a movable seat, the movable seat is axially slidably mounted on the first handle, and the driving sleeve is located at the periphery of the movable seat;

the proximal end of the outer sheath tube is connected to the movable seat, and the driving sleeve is in threaded transmission fit with the movable seat.

Optionally, the locking part is a tubular structure, a part of the side wall of the tubular structure is also used as the force application part, and a hollow area for releasing deformation is arranged between the force application part and the peripheral part.

Optionally, the force application parts are multiple and distributed at intervals along the circumferential direction of the cylindrical structure.

Optionally, the force application part spans at least 1/6 circumference in the circumferential direction of the cylindrical structure.

Optionally, the inner side of the force application part is provided with first anti-slip teeth.

Optionally, one part of the driving sleeve is an insertion section matched with the locking part, the control handle further comprises an elastic locking ring sleeved on the periphery of the insertion section, and the force application part abuts against the elastic locking ring and limits the driving sleeve to rotate in the locking state.

Optionally, an anti-slip structure matched with each other is arranged between the elastic locking ring and the plugging section, and the anti-slip structure comprises at least one of the following modes:

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

and the third anti-slip teeth are distributed on the outer wall of the plug-in section.

Optionally, the second anti-slip tooth and the third anti-slip tooth are engaged with each other.

Optionally, the outer wall of the operating ring is provided with a radially outwards protruding protrusion.

Optionally, the force application part is one or a plurality of force application parts are arranged at intervals along the circumferential direction of the locking part, the inner wall of the operating ring is alternately distributed with concave areas along the circumferential direction and is used as an inner convex area of the working part,

in the locked state, the outer side of the force application part is propped against the inner convex area;

in the unlocking state, the outer side of the force application part corresponds to the concave area.

Optionally, the concave area and the inner convex area are connected through slope transition.

Optionally, the first handle includes:

the movable seat is slidably arranged on the support body, and the driving sleeve is rotatably arranged on the periphery of the support body;

an intermediate sleeve fixed to the support body, a proximal end side of the intermediate sleeve being at an outer periphery of the support body and functioning as the locking portion;

the first shell wraps and fixes the periphery of the middle sleeve, a first gap is formed between the first shell and the radial direction of the locking part, and the operating ring is rotatably installed in the first gap and at least one part of the operating ring is exposed to the first shell.

The interventional instrument conveying system with the locking structure 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 schematic view of the present application in a fully retracted delivery position of an interventional instrument;

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

FIG. 3 is a partial cross-sectional view of the driven member mated with the driving member in accordance with the present application;

FIG. 4 is a partial cross-sectional view along the direction of the latch;

FIG. 5 is a schematic view of a locking portion of the present application;

FIG. 6 is a cross-sectional view taken along line A-A of FIG. 1;

FIG. 7 is a schematic view of the structure of the driving sleeve, the elastic locking ring and the operating ring according to the present application;

FIG. 8 is a schematic view of the engagement of the locking portion and the operating ring of the present application;

FIG. 9 is a schematic view of a first handle according to the present application;

FIG. 10 is a partial cross-sectional view of a first handle of the present application;

FIG. 11 is a partial exploded view of the present application;

FIG. 12 is a schematic view of the structure of the movable seat and the driving sleeve of the present application;

FIGS. 13 a-13 c are schematic views illustrating the movement of an outer sheath relative to an inner sheath in accordance with the present application;

FIG. 14 is a partial cross-sectional view of the present application showing engagement of the latch with the resilient member;

FIG. 15 is a schematic view showing the structure of the latch against the elastic member according to the present application;

FIG. 16 is a partial cross-sectional view of a dual layer structured driving member engaged with a support body in accordance with the present application;

FIG. 17 is a schematic diagram showing the structure of the driving member and the supporting body of the double-layer structure according to the present application;

FIG. 18 is a schematic view of the structure of the elastic member, the indicator latch and the related components according to the present application;

FIG. 19 is a schematic view showing the structure of the elastic member abutting against the first set of indicator teeth according to the present application;

FIG. 20 is a schematic view showing the structure of the elastic member abutting against the second set of indicator teeth according to the present application;

FIG. 21 is a partial exploded view III of the present application;

FIG. 22 is a schematic view of the structure of the sheath of the present application with the loading position fully exposed;

FIG. 23 is a schematic view of the structure of the present application when the sheath is wrapped around the loading site;

FIG. 24 is a schematic view showing a first position of the second handle combined with the first handle according to the present application;

FIG. 25 is a schematic view showing a second position of the second handle slid proximally a predetermined distance in accordance with the present application;

FIG. 26 is a partial cross-sectional view of the first locking mechanism of the present application;

FIG. 27 is an exploded view of the first locking mechanism of the present application;

FIG. 28 is a schematic view showing the structure of the second limiting member in the releasing state according to the present application;

FIG. 29 is a schematic view of a control handle according to another embodiment of the present application;

fig. 30 is a schematic view of the interior of the control handle of fig. 29.

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; 322. a strip-shaped opening; 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; 36. a grip body; 361. a tube outlet;

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; 4326. evacuating the tube;

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. an 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. an elastic member; 912a, an elastic member; 912b, an 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. 1-2, an interventional instrument delivery system having a locking structure is disclosed having opposed distal and proximal ends and an axial direction extending therebetween, the distal end being understood to be oriented relatively away from an operator and the proximal end being oriented relatively close to the operator.

The interventional instrument delivery system comprises a catheter assembly 2 and a control handle 3 connected to a proximal end of the catheter assembly 2, the control handle 3 being adapted to operate the catheter assembly 2 on which the interventional instrument 1 is loadable, the interventional instrument 1 being loaded at a distal end of the catheter assembly 2.

The catheter assembly 2 comprises an inner sheath assembly 21 and an outer sheath 22, wherein the radial clearance between the distal ends of the inner sheath assembly 21 and the outer sheath 22 is a loading position for accommodating the interventional instrument 1, and the inner sheath assembly 21 and the outer sheath 22 are configured to be capable of relative movement, so that the outer sheath 22 covers or exposes the loading position. The distal end of the inner sheath assembly 21 carries a guide head 211 to adapt the catheter assembly 2 for navigation within the body.

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.

In the process of correctly releasing the interventional instrument, the interventional instrument generally needs to be locked when reaching a proper position, and the locking mode is quite common in limiting a driving piece in linkage with the outer sheath, so that the relative fixation of the outer sheath and the first handle and the limiting of the driving piece are also required to be ensured when retracting the sheath core assembly.

In some embodiments, one set of drive mechanisms 4 includes a follower 41 and a driver 42 at the periphery of the follower 41. The driving member may be a hollow driving sleeve 42a with a cylindrical structure, so that an operator can apply a circumferential rotation force conveniently, and the driven member 41 may be a movable seat 41a.

Referring to fig. 3, the movable seat 41a is slidably mounted on the first handle 30 along the axial direction and is used for being connected with a corresponding pipe fitting (i.e. the outer sheath 22), the driving sleeve 42a is rotatably mounted on the first handle 30, and the driving sleeve 42a is in threaded transmission fit with the movable seat 41a, so that the circumferential movement of the driving sleeve 42a is converted into the movement of the movable seat 41a (i.e. the outer sheath 22) along the axial direction.

The driving sleeve 42a is provided with an internal thread 422, the internal thread can be arranged on the inner wall of the driving sleeve, the movable seat 41a is provided with a transmission tooth 412, the internal thread 422 is in threaded transmission fit with the transmission tooth 412 on the movable seat 41a, and thus an operator can drive the movable seat 41a and the connected pipe fitting to slide by rotating the driving sleeve 42 a.

Referring to fig. 4, 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 located 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 is released from the restriction.

The outer periphery of the locking part is rotatably sleeved with an operation ring, the inner wall of the operation ring is provided with a working part which is radially inwards convex and matched with the force application part, and the working part moves along with the operation ring to switch the state of the force application part.

When the outer sheath 22 moves to a proper position relative to the inner sheath assembly 21, an operator applies an acting force to the operating ring, so that the force application part of the locking part enters a locking state, that is, the relative position of the outer sheath can be locked, and the locking position can be any current position in the relative movement process of each pipe fitting, so that the accuracy of the locking position is high.

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.

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.

Referring to fig. 5, the force application portion 311 is an important part for switching the locking 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.

Referring to fig. 6, 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 portion area 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.

Referring to fig. 7, 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, which comprises 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. 8, 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 inner wall structure of the operation ring 312 corresponding to the case where the number of force application portions 311 is 2 in fig. 6, the concave regions 3124 in the inner wall structure are used for accommodating the force application portions 311 when no deformation occurs, the inner convex regions 3123 are closer to the central axis in the radial direction than the concave regions 3124, 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.

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. 9 and 10, in order to better match 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 make the operation progress of the interventional instrument intuitively respond to 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 visual operation progress is realized.

A shielding portion 342 is provided in the first housing 34 in a region facing the indication window 341, and a gap is provided between the shielding portion 342 and the indication window 341 in the radial direction for allowing the stroke indication element 411 to slide in the axial direction.

Some of the embodiments below also provide improvements in terms of travel cues during the relative movement of the interventional instrument during in vivo release, both the outer sheath and the inner sheath tube, which may be combined with embodiments of other parts of the application, such as the mentioned control handle, drive sleeve, movable mount and catheter assembly, may be combined with the embodiments described above.

In some embodiments, referring to fig. 11-12, the control handle 3 is provided with a prompting assembly 6, and the prompting assembly 6 can be connected with the control handle 3 in a split or integrated manner, and when the outer sheath tube 22 moves to a preset relative position relative to the inner sheath tube assembly 21, the prompting assembly 6 responds to the relative position and can be directly fed back to an operator.

In fact, during the movement of the outer sheath 22 relative to the inner sheath assembly 21, it may be necessary to prompt a plurality of relative positions, i.e. a first relative position and a second relative position in sequence along the axial direction, and the prompt assembly may respond to the two relative positions respectively and may be fed back directly to the operator.

Because the operator can continuously hold the control handle in the operation process, the prompt component can provide hand feeling response and/or sound response in a vibration mode, and the operator can timely receive response signals of the hands, namely provide hand feeling, sound feeling or response combining the hand feeling and the sound feeling aiming at the preset relative position, the visual response signals are provided for the hands of the operator when the outer sheath tube 22 moves relatively to the preset relative position, and repeated redundant observation brought by visual signals is avoided.

In order to achieve the aim of responding to a plurality of relative positions, the prompting component comprises a first component and a second component which are acted on each other at each relative position, wherein a plurality of first components are correspondingly arranged at a plurality of preset relative positions and are axially arranged at intervals, and for each relative position, the second component interacts with the first components with different axial positions, namely, the second component slides along the axial direction and meets each first component to generate one response, so that the aim of multiple responses is achieved.

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.

Preferably, the first component adopts a prompting latch, the second component adopts an elastic piece, the elastic piece and the prompting latch are propped against each other (namely propped against each other along the radial direction of the control handle) in a state of opposite positions, and the deformation of the elastic piece at least allows the prompting latch to pass over the elastic piece, so that a sound effect is generated when the prompting latch passes over the elastic piece, and finally, the change effect of hand feeling and/or sound is transmitted to an operator.

In some embodiments, the control handle 3 further includes a prompting latch 60 (i.e. the first component) connected to the driving sleeve 42a and an elastic member 7 (i.e. the second component) connected to the movable seat 41a, wherein the elastic member 7 may be connected to the movable seat 41a by a detachable structure such as a snap-fit, a plug-in, a socket-connection, etc., and the prompting latch 60 is the same.

When the elastic member 7 moves axially along with the movable seat 41a to correspond to the position of the prompting latch 60, wherein the position of the prompting latch 60 can be understood as a preset interval position, the elastic member 7 and the prompting latch 60 act with each other to provide a hand feeling response and/or a sound response, that is, a response to the preset interval position, so that the effect of providing the hand feeling and/or the sound response when the sheath tube moves relatively to the preset interval position is finally achieved.

The elastic piece 7 and the prompting latch 60 are abutted against each other along the radial direction of the control handle under the condition of acting each other so as to release the axial movement of each other, so that the components can be more flexibly configured, and the space is reasonably utilized.

The resilient member 7 and the indicator tooth 60 interact to provide a tactile and/or audible response when the outer sheath 22 is moved to a predetermined relative position with respect to the inner sheath tube assembly 21.

In fact, during the movement of the outer sheath 22 relative to the inner sheath assembly 21, it may be necessary to prompt a plurality of relative positions, including at least a first relative position and a second relative position that are sequentially adjacent in the axial direction, and the elastic member 7 and the prompting latch 60 may respectively respond to the two relative positions and may be directly fed back to the operator.

Referring to fig. 13a, in the first relative position, the outer sheath is in the fully stowed position, the position of the outer sheath 22 is designated P1, and the position of the follower 41, which is in communication with the outer sheath 22, is designated P2. Referring to fig. 13c, when the outer sheath is in the fully exposed loading position, i.e., the engagement portion 212 of the inner sheath assembly 21 is fully exposed, 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. 13b, the second relative position is a position between the first relative position and the fully released position (which may be a half-released position, etc.), 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 stroke of the outer sheath 22 is M1 (i.e., the distance between P1 and P1″), and the total stroke of the movable mount 41a is also M1 due to the interlocking of the outer sheath 22 and the movable mount 41 a. 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.

At a predetermined relative position, which is not limited to a point in time, relative to the inner sheath assembly 21, may correspond to a small stroke (in the axial direction) of the outer sheath 22, which may correspond to a multiple turn range of the drive sleeve, in which the latch is prompted to respond multiple times. Preferably, the prompting latch responds for a plurality of times when the rotation amplitude of the driving sleeve is less than or equal to one circle.

Referring to fig. 14 to 15, the indicating latch 60 is located at the inner side of the driving sleeve 42a, and the indicating latch 60 avoids the movement path of the driving gear 412, which can be understood that the movement paths of the indicating latch 60 and the driving gear 412 in the radial space do not interfere with each other, so that the indicating latch 60 does not affect the threaded transmission between the driving sleeve 42a and the movable seat 41 a.

The elastic member 7 and the prompting latch 60 are propped against each other in a state that the positions of the elastic member 7 correspond to each other, the deformation of the elastic member 7 at least allows the prompting latch 60 to rotate along with the driving sleeve 42a and pass over the elastic member 7, as shown in the figure, the highest circumferential point of the elastic member 7 is higher than the lowest circumferential point of the prompting latch 60, the elastic member 7 and the prompting latch 60 are propped against each other in the circumferential direction in the state that the positions of the elastic member and the prompting latch 60 are propped against each other, the deformation of the elastic member 7 at least allows the prompting latch 60 to rotate along with the driving sleeve 42a and pass over the elastic member 7, and accordingly, the prompting latch 60 passes over the elastic member 7 to generate a sound effect, and finally, the operator is transmitted with a change effect of hand feeling and/or sound.

In order to enable the key position or progress of the operation of the interventional instrument to be fed back to an operator more timely and rapidly, the embodiment introduces a matched structure of the prompting latch and the elastic piece, is assisted with a hand feeling or sound effect prompting function, directly conveys the operation progress to the operator, and is beneficial to more accurate and sensitive judgment of the operation progress by the operator.

Referring to fig. 16 to 17, in order to further secure stability of the threaded driving engagement between the driving sleeve 42a and the movable seat 41a, the first handle 30 at least includes a support body 32, the support body 32 is provided with a guide groove 321 extending along an axial direction, the movable seat 41a is slidably engaged with the guide groove 321, the driving sleeve 42a is rotatably mounted on an outer periphery of the support body 32, and the guide groove 321 plays a role in limiting circumferential rotation of the movable seat 41a, so that the movable seat 41a can only slide along the axial direction, that is, through a limiting effect of the guide groove 321.

The support body 32 is cylindrical (other pipe fittings can be penetrated in the interior), the guide groove 321 penetrates through the radial direction of the support body 32, the movable seat 41a is provided with transmission teeth 412 which extend out of the guide groove 321 and are in threaded fit with the driving sleeve 42a on two radial sides of the support body 32, stable meshing transmission of the transmission teeth 412 and the internal threads 422 is ensured, and unnecessary deflection or dislocation is reduced.

Regarding the structural design of the driving member, the driving member 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 indicator teeth 60 may be suitable for the above-mentioned embodiments.

For easy processing and assembly, as shown in fig. 16, the driving sleeve 42a may also adopt a double-layer structure with a bushing 423 and a casing 424, and a rotation stopping structure (rotation limiting) is disposed between the casing 424 and the bushing 423, so that the casing 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 movable seat 41 a.

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

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 engagement of the indicator latch 60 with the elastic member 7 is not limited to a certain point, and preferably corresponds to a small stroke of the driven member, and in this process, the indicator latch 60 can be indicated for a plurality of times, so that the operator is informed, and thus the indicator latch 60 has a corresponding extension length in the axial direction and the circumferential direction of the support body. The matching accommodating hole 4231 is a bar-shaped hole, the shape of the matching accommodating hole is corresponding to that of the prompting latch 60, the extending direction of the bar-shaped hole is consistent with the thread angle of the internal thread, the matching accommodating hole is just suitable for the axial movement component of the driven piece, and the prompting latch 60 and the elastic piece 7 are ensured to prompt for multiple times and stable effect in the matching process.

Referring to fig. 18 to 20, the elastic member is an important component that cooperates with the prompting latch and generates the sound prompting effect, and for better fixing the 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 supporting body 32, the driving tooth 412 is fixed on the sliding portion 4131, and the elastic member 7 may be directly or indirectly connected to the sliding portion 4131.

The following provides an improved way of indirectly connecting the elastic member 7 with the sliding portion 4131, as in fig. 18, the 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 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 elastic member, the 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 elastic member 7.

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 of the elastic piece 7 when the prompting latch passes over the elastic piece 7 can be controlled within the minimum range.

The middle piece 8 is provided with deformation release openings 82 between two ends of the bridge arm 72, so that most acting force can be released from the deformation release openings 82 when the bridge arm 72 is extruded by the prompting latch, and damage caused by large deformation of the bridge arm is avoided.

Elastic pieces 7 are arranged on two radial sides of the middle piece 8, so that the elastic pieces 7 on two sides can abut against corresponding prompting latches and generate an acoustic prompting effect, and the overall prompting effect of the application is further enhanced.

Regarding the fitting details of the teeth 62, the projections 71 and the bridging wall, it is suggested that the tooth tips of the teeth 62 in the latch are not lower than the groove bottoms of the thread grooves of the internal thread 422 in the radial direction, so that the movement paths of the teeth 62 and the internal thread 422 do not interfere. The height of the projection 71 in the radial direction is between the tip and the root of the tooth 62, so that the bridge arm 72 can recover its shape when the projection 71 reaches a position corresponding to the bottom of the tooth 62.

The bridge arm 72 is placed in the thread groove of the internal thread 422, and the bridge arm 72 has a deformation energy storage state and a reset state. When the bridge arm 72 and the bulge 71 are propped against the groove bottom of the thread groove, the bridge arm 72 is stressed and deformed and stores energy, namely, the bridge arm 72 is in a deformed energy storage state at the moment; when the position of the protrusion 71 corresponds to the tooth root of the tooth 62, the bridge arm 72 is reset due to the elastic restoring force of the bridge arm 72, i.e. the bridge arm 72 is in a reset state at this time.

With the continuous rotation of the driving sleeve 42a, the protrusion 71 continuously contacts with the prompting latch when further moving along the radial direction, and the protrusion 71 repeatedly arrives at the corresponding position with the tooth tip or tooth root of the convex tooth 62, so that the protrusion 71 is reciprocally switched in the deformation energy storage state and the reset state, and each switching, namely, the convex tooth 62 passes over the protrusion 71, and a sound effect is generated.

Regarding the number and placement requirements of the prompting latches, one or more than two groups of prompting latches are arranged in the axial direction of the control handle, and the same group of prompting latches are one or more than one group of prompting latches distributed at intervals along the circumferential direction of the bushing 423, for example, 2 groups of prompting latches are distributed at intervals along the circumferential direction of the bushing 423 in fig. 18, so that at least one group of sound effect is generated by the prompting latches, and the change effect of hand feeling and sound is transmitted to an operator.

The same prompting latch extends 1/4-1/2 circumference in the circumferential direction of the bushing 423, so that the prompting latch is ensured to generate sound effects of each group for a sufficient time, so that an operator can recognize and react conveniently.

In order to further strengthen the strength and the sound effect prompt effect of the prompt latch, the prompt latch comprises a body 61 which is arc-shaped as a whole and convex teeth 62 which are distributed on the inner side of the body, wherein the convex teeth 62 are distributed at intervals along the extending direction of the body 61, the plurality of convex teeth not only strengthen the structural strength of the body, but also can generate rhythmic multiple sound effect prompts when the prompt latch is propped against an elastic piece, so that the prompt latch can more draw attention of an operator, and the sound prompt effect is better.

In order to make the outer periphery of the body of the prompting latch better fit with the outer shell, the outer periphery of the body 61 is of a smooth structure, or if a large gap exists between the outer shell and the outer periphery of the body, the outer side of the body 61 is provided with protruding space occupying pieces 63 at intervals, so that the placement position of the prompting latch is more stable.

The inner wall of the casing 424 directly abuts against the outer periphery of the body 61 and/or abuts against the space occupying member 63, so that the inner wall of the casing 424 can be directly attached to the body 61 of the prompting latch or can abut against the space occupying member 63, the shape of the inner wall of the casing 424 is not limited by the requirement of fixing the prompting latch, and the shape of the inner cavity is not limited to a straight cylinder.

Each set of indicator teeth 60 is spaced axially from the axial end face of the drive sleeve 42a, i.e., each set of indicator teeth is disposed axially between the proximal and distal end faces of the drive sleeve 42a and is not disposed at either of these end faces.

In combination with the travel of the outer sheath between the first and second relative positions being M2, the spacing of the two sets of cue teeth corresponding to the first and second relative positions in the axial direction of the sleeve 423 is also M2.

In addition, the operator needs to give a prompt when the interventional instrument is about to reach a specific state, so that the relative position change of the prompting latch and the driven member actually corresponds to the release progress of the interventional instrument.

During the relative movement of the outer sheath 22 with respect to the inner sheath assembly 21, at least:

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, in which the interventional instrument is allowed to disengage from the interventional instrument delivery system for full release;

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 on the inner sheath assembly 21 through the connection lug, and in the above-described half-release position, the connection 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).

Based on the above-mentioned practical requirements, as shown in fig. 19 to 20, the present application sets 2 sets of prompting latches corresponding to the fully retracted position and the half released position of the interventional device respectively, and when the elastic member 7 abuts against the first set of prompting latches 60a, the outer sheath 22 connected to the movable seat 41a fully accommodates the interventional device, and at this time, the operator is prompted to be unable to drive the outer sheath to the distal end.

The second set of prompting latches 60b is located at the proximal end side of the first set of prompting latches 60a, when the elastic member abuts against the second set of prompting latches 60b, the outer sheath connected with the driven member is half-released from the interventional device, that is, the proximal end of the interventional device and the interventional device conveying system are not completely released, for example, in the half-release position, the engagement portion 212 between the connecting lug of the interventional device and the inner sheath assembly 21 is still wrapped by the distal end of the outer sheath, and if the interventional device 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.

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

After the interventional instrument is correctly released, the control handle needs to push the outer sheath tube to the far end to restore the catheter assembly to the initial position, namely, the state suitable for in-vivo passing, but the existing control handle generally adopts a single thread driving structure, the movement of the outer sheath tube is slow, and the adjustment efficiency is low.

To overcome the above-described problems and to increase the efficiency of adjustment of the catheter assembly, the control handle of some embodiments described below may be directly actuated to rapidly retract the inner sheath assembly proximally so that the catheter assembly is quickly returned to its original position.

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 handle, which can be combined with the embodiments above.

In some embodiments, referring to fig. 21-23, control handle 3 includes a primary handle 30 coupled to outer sheath 22 and a plurality of sets of drive mechanisms, each set of drive mechanisms in driving engagement with a corresponding tube in catheter assembly 2.

One of the sets of drive mechanisms comprises a second handle 9 and at least one set of locking mechanisms arranged between the first handle 30 and the second handle 9. The second handle 9 is located on the proximal side of the first handle 30 for connection to the inner sheath assembly 21. The first handle 30 is coupled to the outer sheath 22 and is axially slidable relative to the inner sheath assembly 21 by driving the outer sheath 22.

When the outer sheath 22 moves relative to the inner sheath assembly 21, the inner sheath assembly 21 is fixedly connected to the second handle 9, and the outer sheath 22 is fixedly connected to the first handle 30, so as to control the relative positions of the pipe elements.

The second handle 9 has a first position, which is switchable between a position in which the second handle 9 is coupled to the first handle 30, and a second position, which is switchable between a position in which the second handle 9 is uncoupled from the first handle 30 and is slidable proximally a predetermined distance, i.e. the inner sheath assembly 21 is slidable axially proximally a predetermined distance. The locking mechanism is used for switching and maintaining the first position and the second position, i.e. switching the axial relative positions of the second handle 9 and the first handle 30 and maintaining them relatively stable.

The locking mechanism specifically comprises a state assembly and a limiting piece, wherein the limiting piece is of an annular structure, is sleeved and is installed on one of the first handle 30 and the second handle 9 in a sliding manner along the radial direction, the inner edge of the annular structure is used as a locking piece matched with the other one of the first handle 30 and the second handle 9, and the locking piece abuts against the corresponding handle or stretches into a hole or a 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 locking mechanism comprises a first locking mechanism 91 for holding the first handle 30 in the above-mentioned first position, and a second locking mechanism 92 for holding the first handle 30 in the second position, the first locking mechanism 91 cooperating with the proximal end portion of the first handle 30 to thereby hold the second handle 9 in the first position, while the second handle 9 is held axially relatively fixed to the first handle 30 by the first locking mechanism 91.

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 state assembly comprises an elastic member 912 and a control button 913, the 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 is linked with the first limiting member 911 to drive the first limiting member 911 to enter a unlocking state.

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 state assembly comprises a spring 922 and an unlocking button 923, the spring 922 acts between the first handle 30 and the second limiting member 921 to drive the second limiting member 921 to enter a locking state, and the unlocking button 923 is fixed on the second limiting member 921 to drive the second limiting member 921 to enter a releasing state. Some embodiments below provide improvements to the first and second locking mechanisms.

In some embodiments, one of the sets of drive mechanisms includes a second handle 9, an extension sleeve 93, a first locking mechanism 91, and a second locking mechanism 92, wherein the second handle 9 is located on the proximal side of the first handle 30 and is adapted to be coupled to the inner sheath assembly 21, and wherein relative movement between the second handle 9 and the first handle 30 is also synchronously reflected as relative movement of the inner sheath assembly 21 and the outer sheath 22. The proximal end of the extension sleeve 93 is fixedly connected to the second handle 9 by means of a snap fit or the like, and the proximal end of the extension sleeve 93 cooperates with the first locking mechanism 91. The distal end of the extension sleeve 93 extends into the interior of the first handle 30 and mates with the second locking mechanism 92.

The second handle 9 has a switchable first position, which is understood to be the position in which the second handle 9 is coupled to the first handle 30, and a second position, which is understood to be the position in which the second handle 9 is decoupled from the first handle 30 and is slidable proximally a predetermined distance, which may be constrained by the cooperation of the extension sleeve 93 and the second locking mechanism 92, while the second locking mechanism 92 is used to hold the second handle 9 in the second position.

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, i.e., the second handle 9 is held axially relatively fixed to the first handle 30 by the first locking mechanism 91.

When the locking action of the first locking mechanism 91 is released, the second handle 9 can be switched to the second position, i.e. the second handle 9 slides proximally relative to the first handle 30, and the extension sleeve 93 also slides proximally following the second handle 9.

When the second handle 9 is slid to the preset position, the second locking mechanism 92 acts on and locks the extension sleeve 93, thereby holding the second handle 9 in the second position, enabling the second handle 9 to drive the inner sheath assembly 21 to rapidly withdraw proximally in an axial direction and maintain the relative position.

The distal end of the outer sheath 22 abuts or slightly wraps around the proximal end of the guide head 211 (i.e., the initial position described above) when the catheter assembly 2 is being passed in the body, preventing exposure of the interventional instrument when the second handle 9 is in the first position.

After the interventional device 1 is completely released, the loading position is completely exposed (i.e. the release position is described above), the distance between the distal end of the outer sheath 22 and the guide head is L, the catheter assembly 2 needs to be withdrawn from the body at this time, the efficiency is low if the outer sheath 22 is driven to move distally and reach the guide head by the threads, the first locking mechanism 91 can be unlocked at this time, the second handle 9 is driven to retract the inner sheath assembly 21 quickly, so that the distal end of the outer sheath 22 abuts against or is slightly wrapped around the proximal end portion of the guide head (as shown in fig. 23), the second handle 9 is at and kept at the second position, the stroke of the second handle 9 is L during this process, and finally, the first handle 30 and the second handle 9 are moved synchronously, all the tubes are withdrawn from the body, the relative displacement of the first handle and the second handle is prevented by the second locking mechanism 92 during retraction, and the obstruction of the guide head due to the exposure of the proximal end can be avoided.

Compared with the single thread driving mode of the catheter assembly in the prior art, the application introduces a new driving mode based on the existing single driving mode, assists the stage of proximally withdrawing the inner sheath assembly 21, can realize the rapid proximally withdrawing 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.

According to the application, the relative positions of the outer sheath 22 and the inner sheath assembly 21 are directly adjusted by changing the relative positions of the first handle and the second handle, and when an operator rapidly switches the second handle to the second position, rapid retraction of the inner sheath assembly 21 is synchronously realized, the relative position adjustment efficiency between the pipe fittings is also improved, and a more control effect and operation experience are achieved.

The two sets of locking mechanisms are used for keeping the first handle and the second handle at different relative positions, namely, the positions of the outer sheath 22 and the inner sheath assembly 21 are locked at the relative positions, so that adverse effects caused by misoperation are avoided.

In addition, the quick withdrawal distance of the second handle is constrained by the extension sleeve and can be maintained in a relative position by the second locking mechanism 92, and then all the tubes are synchronously driven to withdraw from the body by the whole control handle, thereby achieving the purpose of quickly and timely adjusting the catheter assembly.

Referring to fig. 24 to 25, 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 proximal end of the extension sleeve 93 can be fixedly connected to the tube joint 902 by a clamping structure 933, and the interior of the extension sleeve 93 is a threading channel of the inner sheath assembly 21.

In the first position, the proximal end of the first handle 30 serves as the attachment section 35 and extends into the distal end of the second housing 901, a first lock

The first lock mechanism 91 includes an elastic member 912, a first stopper 911 movably mounted in the second housing 901, and a control knob 913 movably fitted in the second housing 901.

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 disengaged from the connection section 35, so that an operator can move the second handle 9 further proximally relative to the first handle 30 to directly drive the controlled tube, and the controlled tube is rapidly retracted proximally while pulling the second handle 9 because of no transmission members such as threads and gears.

The outer wall of the connecting section 35 is provided with a first locking groove 351 matched with the first limiting piece 911, and the first limiting piece 911 is clamped into the first locking groove 351 to axially limit in a locking state.

Referring to fig. 26 to 27, the 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 when no external force is applied, the initial state of the first limiting member 911 is in the locked state (safety can be improved), and when the operator needs to switch the first limiting member 911 to the unlocked state, only the elastic force of the elastic member 912 needs to be overcome.

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.

Preferably, the first limiting member 911 is in a ring structure and is sleeved on the outer periphery of the connecting section 35, the elastic member 912 and the control button 913 act on two opposite sides of the first limiting member 911 in the radial direction, and when the operator presses the control button 913, the pressing force is directly transmitted to the first limiting member 911 to generate displacement and enter a lock releasing state. The annular structure not only fully utilizes the space inside the second shell, but also enables the first limiting piece to have enough structural strength.

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 elastic members (elastic member 912a, elastic member 912 b) and the control buttons (control buttons 913a, 913 b) in the two sets are mirror images distributed, corresponding to the respective first stoppers (first stoppers 911a, 911 b).

One end of the 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 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 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 knob more stable for transmitting the acting force, the control knob 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 elastic member in the other sleeve, so that the abutting ends of the first limiting member and the 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 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 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 avoided on the side of the second receiving groove 9132 of the control button 913.

Referring to fig. 28, the proximal end of the extension sleeve 93 may be fixedly attached to the second handle 9 by means of a snap fit or the like (improvements are provided below), and the distal end of the extension sleeve 93 extends into the interior of the first handle 30 and cooperates with the second locking mechanism 92 to retain the second handle 9 in the second position.

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, as shown in fig. 25 and 28, the anti-disengaging structure 932 includes an outer protruding portion 9321 and a stop portion 9322, wherein the outer protruding portion 9321 is located at a proximal end of the extension sleeve 93 and protrudes radially from the extension sleeve 93, the stop portion 9322 is located inside the first handle 30, and the stop portion 9322 is distributed on an outer periphery of the outer protruding portion 9321 and keeps the outer protruding portion 9321 from moving further proximally.

In addition, the extension sleeve is provided with a rib 934, and the stop part 9322 is provided with a limit groove matched with the rib 934, so that the extension sleeve has the function of preventing the extension sleeve from rotating in the movement process.

In some embodiments, as shown in fig. 28, the second locking mechanism 92 includes a second stopper 921 fitted around the outer periphery of the extension sleeve, 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.

Regarding the fitting structure of the extension sleeve and the second locking mechanism, the second locking groove 931 that is matched with the second limiting member 921 is provided on the outer periphery of the extension sleeve 93, the second locking member 9211 that is matched with the second locking groove 931 is provided on the inner edge of the second limiting member 921, the second limiting member 921 has a locking state that is matched with the extension sleeve 93 and a releasing state that is released from the fitting, the spring 922 drives the second limiting member 921 into the locking state, and the releasing button 923 drives the second limiting member 921 into the releasing state.

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

When the second handle 9 is in the first position, the second housing 901 shields the unlocking button 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 applied force can directly act on 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.

Referring to fig. 29-30, the present application also discloses an interventional instrument delivery system having opposite distal and proximal ends and an axial direction extending therebetween, the delivery system comprising a catheter assembly 2 and a control handle 3, the catheter assembly 2 comprising an inner sheath assembly and an outer sheath, the radial clearance of the distal ends of both the inner sheath assembly 21 and the outer sheath 22 being a loading location for receiving an interventional instrument 1; the control handle 3 includes:

The support body 32, the support body 32 is cylindrical, and a strip-shaped opening 322 for guiding is formed in the side wall of the support body;

the sliding seat is axially and slidably arranged on the supporting body 32, and the outer wall of the sliding seat is provided with a transmission tooth 412 and an elastic piece; the transmission teeth 412 extend to the outside of the support body 32 through the strip-shaped openings 322;

the driving member 42 is rotatably mounted on the support body 32, the driving member 42 is disposed at the periphery of the sliding seat, the inner wall of the driving member 42 is provided with a prompting latch 60 and an internal thread 422 matched with the driving gear 412, the prompting latch 60 comprises a body which is arc-shaped as a whole and convex teeth distributed on the inner side of the body, and when the elastic member moves axially along with the sliding seat to the position of the prompting latch 60, the elastic member and the convex teeth of the prompting latch 60 interact with each other to provide a hand feeling response and/or a sound response.

The evacuation tube 4326 is communicated with the gap between the inner sheath assembly and the outer sheath; and the drain tube 4326 extends to the distal end side of the control handle 3 via the inside of the slide seat. At the extension outlet of the evacuation tube 4326, the handle may be separated from the distal end side of the handle, or referring to the embodiment shown in the drawings, the control handle 3 includes a holding body 36 mounted on the distal end side of the support body 32, the holding body 36 is provided with a tube outlet 361, and the evacuation tube 4326 extends to the outside of the control handle 3 through the tube outlet 361. The holding body 36 may be integrally provided with the support body 32, that is, they may be different parts of the same component, or they may be separately provided and assembled with each other. In the mating relationship, the tube outlet 361 extends in the axial direction of the gripping body 36; the extending direction of the opening of the pipe fitting outlet 361 is consistent with the moving direction of the sliding seat; the travel of the opening of the tube outlet 361 is greater than or equal to the travel of the sliding seat.

As in the above, the driving member 42 in this embodiment can also be locked by the above-mentioned locking mechanism, that is, a part of the first handle 30 shown in fig. 4 is a locking portion 31 located at the outer periphery of the driving sleeve 42a, at least a part of the locking portion 31 is a radially deformable force applying portion 311, and the force applying portion 311 has a locked state of acting with the driving sleeve 42a to restrict rotation of the driving sleeve 42a, and a released state of releasing the restriction. Specific details of the arrangement may be understood and implemented by those skilled in the art without objection in the above description, and are not described herein.

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. An interventional instrument delivery system having a locking structure, having opposed distal and proximal ends and an axial direction extending therebetween, the interventional instrument delivery system comprising a catheter assembly and a control handle connected to the proximal end of the catheter assembly, the catheter assembly including an inner sheath assembly and an outer sheath, a radial gap between the distal ends of the inner sheath assembly and the outer sheath being a loading location for receiving an interventional instrument, the inner sheath assembly and the outer sheath being configured for relative movement such that the outer sheath encases or exposes the loading location;

the control handle comprises a first handle and a plurality of sets of driving mechanisms, and each set of driving mechanism is in transmission fit with a corresponding pipe fitting in the catheter assembly; the device is characterized in that one set of driving mechanism comprises:

2. The interventional instrument delivery system with locking structure of claim 1, wherein the drive mechanism further comprises a movable seat slidably mounted axially to the first handle, the drive sleeve being at an outer periphery of the movable seat;

3. The interventional instrument delivery system with locking structure of claim 1, wherein the locking portion is a cylindrical structure, a portion of a sidewall of the cylindrical structure doubles as the force applying portion, and a hollow area for releasing deformation is provided between the force applying portion and the peripheral portion.

4. The interventional instrument delivery system with locking structure of claim 3, wherein the force applying portions are plural and circumferentially spaced apart along the tubular structure.

5. The interventional instrument delivery system with locking structure of claim 4, wherein the force applying portion spans at least 1/6 circumference in a circumferential direction of the tubular structure.

6. The interventional instrument delivery system with locking structure of claim 3, wherein the force applying portion carries a first anti-slip tooth on an inner side thereof.

7. The interventional instrument delivery system with locking structure of claim 1, wherein a cooperating anti-slip structure is provided between the elastic locking ring and the insertion section, the anti-slip structure comprising at least one of:

8. The interventional instrument delivery system with locking structure of claim 7, wherein the second anti-slip tooth and the third anti-slip tooth intermesh.

9. The interventional instrument delivery system with locking structure according to claim 1, wherein the outer wall of the operating ring is provided with radially outwardly protruding protrusions.

10. The interventional instrument delivery system with locking structure according to claim 1, wherein the force application part is one or a plurality of force application parts which are circumferentially arranged at intervals along the locking part, the inner wall of the operating ring is alternately distributed with concave areas along the circumferential direction and inner convex areas serving as the working parts,

11. The interventional instrument delivery system with locking structure of claim 10, wherein the concave region and the convex region are engaged by a ramp transition.

12. The interventional instrument delivery system with locking structure of claim 2, wherein the first handle comprises: