CN112823751B

CN112823751B - Rotary mandrel assembly, control handle, valve suture device and valve suture system

Info

Publication number: CN112823751B
Application number: CN201911161739.XA
Authority: CN
Inventors: 李阳; 黄广念; 张庭超
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2019-11-21
Filing date: 2019-11-21
Publication date: 2024-09-20
Anticipated expiration: 2039-11-21
Also published as: CN112823751A

Abstract

The invention provides a rotary mandrel assembly, which is applied to a valve suture device, the valve suture device comprises a sheath tube and a plurality of elongated pieces penetrating into the sheath tube, the rotary mandrel assembly comprises a rotary mandrel, the distal end of the rotary mandrel is provided with a transition guide part, the distal end of the transition guide part is adjacent to the proximal end of the sheath tube, the cross-sectional area of the transition guide part perpendicular to the axial direction is gradually increased from the distal end to the proximal end, the outer surface of the transition guide part is provided with a plurality of channels which are mutually spaced and penetrate through the proximal end and the distal end of the transition guide part, so that the plurality of elongated pieces are correspondingly penetrated by each other, and the plurality of elongated pieces are gathered relatively at the distal end of the transition guide part and spread relatively at the proximal end of the transition guide part; the rotary mandrel assembly can conveniently diffuse and install a plurality of slender components, and reduce the processing and assembly difficulty. The invention also provides a control handle, a valve suture device and a valve suture system provided with the rotary mandrel assembly.

Description

Rotary mandrel assembly, control handle, valve suture device and valve suture system

Technical Field

The invention relates to the technical field of medical instruments, in particular to a rotary mandrel assembly, a control handle, a valve suture device and a valve suture system.

Background

The tricuspid valve is a one-way valve between the right atrium and the right ventricle, and the anatomical structure of the tricuspid valve comprises an annulus, valve leaflets, chordae tendineae and papillary muscles, wherein the valve leaflets consist of front valve, rear valve and partition valve, the annulus is an attachment edge of three valve leaflets, and the free edge of each valve leaflet is connected with the papillary muscles by the chordae tendineae. The normal tricuspid valve can ensure that blood flows from the right atrium to the right ventricle, and when the right ventricle contracts to squeeze indoor blood, the tricuspid valve is closed, and the blood cannot flow into the right atrium, so that the blood of the right ventricle is sent into the pulmonary artery from the pulmonary valve.

Tricuspid valve regurgitation is characterized in that right ventricular blood in systole caused by tricuspid valve insufficiency flows back to the right atrium and then flows into the upper and lower vena cava, so that the volume of the right atrium is enlarged, the pressure is increased, the right ventricular load is increased, and heart failure is easily caused.

The traditional treatment mode of tricuspid regurgitation is valve repair or replacement through surgery, which can relieve symptoms of patients and prolong the service life of the patients. However, surgery has the disadvantages of being traumatic, slow to recover, high risk, etc. In recent years, treatment of tricuspid regurgitation by minimally invasive intervention has become a focus of research. A minimally invasive transcatheter valve repair instrument requires the centralized placement of a plurality of elongated members extending through to the distal end of the instrument within a sheath of very limited radial dimensions that are mounted to a steering handle to enable the instrument to perform various actions such as grasping the leaflets, penetrating the leaflets, pulling out sutures, etc., by actuating corresponding operating elements on the handle. How to effectively install and control the components concentrated in the sheath tube with small diameter in the control handle, ensure smooth action of the components, reduce processing and assembly difficulties and be a great technical problem for the person skilled in the art.

Disclosure of Invention

The invention aims to overcome the defects of the prior art and provides a rotary mandrel assembly, a control handle, a valve suture device and a valve suture system, wherein the rotary mandrel assembly can be used for conveniently and diffusely installing a plurality of elongated pieces, does not obstruct the movement of the elongated pieces and can reduce the processing and assembling difficulties.

In order to solve the technical problems, the invention provides a rotary mandrel assembly applied to a valve suture device, the valve suture device comprises a sheath tube and a plurality of elongated pieces penetrating into the sheath tube, the rotary mandrel assembly comprises a rotary mandrel, the distal end of the rotary mandrel is provided with a transition guide part, the distal end of the transition guide part is adjacent to the proximal end of the sheath tube, the cross-sectional area of the transition guide part perpendicular to the axial direction is gradually increased from the distal end to the proximal end, the outer surface of the transition guide part is provided with a plurality of channels which are mutually spaced and penetrate through the proximal end and the distal end of the transition guide part so as to respectively allow the plurality of elongated pieces to correspondingly penetrate through, and the plurality of elongated pieces are gathered relatively at the distal end of the transition guide part and spread relatively at the proximal end of the transition guide part.

The invention also provides a control handle, which comprises a shell, the rotary mandrel assembly and a plurality of motion control modules, wherein the rotary mandrel assembly axially extends in the shell, the far end of the transition guide part extends out of the shell, the plurality of motion control modules are arranged on the shell, and the plurality of slender pieces are respectively connected with the corresponding motion control modules after being diffused by the transition guide part of the rotary mandrel.

The invention also provides a valve suture device which comprises the control handle, the sheath fixedly connected with the distal end of the rotary mandrel module and the plurality of elongated members penetrating into the sheath.

The invention also provides a valve suture system comprising the valve suture device and a clamp for fixing the control handle of the valve suture device.

The transition guide part is arranged at the distal end of the rotating mandrel assembly, the cross-sectional area of the transition guide part perpendicular to the axial direction is gradually increased from the distal end to the proximal end, the outer surface of the transition guide part is provided with the plurality of channels which are mutually spaced and penetrate through the proximal end and the distal end of the transition guide part so as to respectively and correspondingly insert the plurality of slender pieces, the plurality of slender pieces can be gathered relatively at the distal end of the transition guide part and spread relatively at the proximal end of the transition guide part, and the space among the plurality of diffused slender pieces is increased, so that the plurality of slender pieces are more convenient to install and operate; the channels are isolated from each other, so that the elongated members can be controlled independently and are not interfered with each other, and the elongated members can move smoothly. According to the control handle, the valve suture device and the valve suture system, the rotary mandrel assembly is arranged, the plurality of slender pieces can be conveniently and respectively connected with the corresponding action control modules on the control handle after being diffused through the transition guide parts of the rotary mandrel, and the size of each action control module can be relatively larger due to the fact that the space between the plurality of diffused slender pieces is increased, so that the processing and assembling difficulty is greatly reduced.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings that are needed in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

Fig. 1 is a schematic perspective view of a valve suture system of the present invention.

FIG. 2 is a schematic perspective view of a valve suture device and an adjustable curved sheath of the valve suture system of the present invention

Fig. 3 is a schematic perspective view of a valve suture instrument of the present invention.

Fig. 4 is an exploded perspective view of the valve suture instrument of the present invention at one viewing angle.

Fig. 5 is an exploded perspective view of the valve suture instrument of the present invention at another viewing angle.

Fig. 6 is a schematic perspective view of the chuck push tube, pin, probe and guide wire of the present invention separated from the rotating mandrel.

Fig. 7 is a schematic perspective view of the guide wire, the collet push tube, the pin and the probe of fig. 6 assembled with a rotating mandrel.

Fig. 8 is an enlarged view of the rotating mandrel of fig. 6.

Fig. 9 is a schematic perspective view of the rotary mandrel of fig. 8 from another perspective.

Fig. 10 is an enlarged view of the X portion in fig. 8.

Fig. 11 is a schematic perspective view of a rotary operating mechanism and a distal end of a rotary mandrel assembly according to the present invention.

FIG. 12 is a schematic cross-sectional view of the intrathecal structure of the valve suture instrument of the present invention.

Fig. 13 is a schematic perspective view of the rotary operating mechanism and the rotary spindle in fig. 11 assembled.

Fig. 14 is an exploded perspective view of the valve suture instrument of the present invention.

FIG. 15 is a cross-sectional view of the valve suture instrument of FIG. 4 along the XV-XV line.

Fig. 16-17 are schematic views of the use of the cartridge opening and closing control module on the operating handle of the valve suture instrument of the present invention.

Fig. 18-19 are schematic views of the use of the probe movement control module on the steering handle of the valve suture instrument of the present invention.

Fig. 20-22 are schematic views of the use of the pin lock control module on the operating handle of the valve suture instrument of the present invention.

Detailed Description

The following description of the embodiments of the present invention 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 invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without undue burden, are within the scope of the invention.

Furthermore, the following description of the embodiments refers to the accompanying drawings, which illustrate specific embodiments in which the invention may be practiced. Directional terms, such as "far", "near", "upper", "lower", "front", "rear", "left", "right", "inner", "outer", "side", etc., in the present invention are merely referring to directions of the attached drawings, and thus, directional terms are used for better, more clear explanation and understanding of the present invention, rather than indicating or implying that the apparatus or element being referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the present invention.

To more clearly describe the structure of the rotating mandrel assembly, the steering handle, the valve suture device, and the valve suture system of the present application, the term "proximal" and "distal" are defined herein as terms commonly used in the interventional medical arts. Specifically, "distal" refers to the end that is distal from the operator during a surgical procedure, and "proximal" refers to the end that is proximal to the operator during a surgical procedure. 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 in the description of the application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

Referring to fig. 1 and 2, the present invention provides a valve suture system 100 comprising a valve suture device 20, an adjustable curved sheath 30, and a clamp 50.

Referring to fig. 2-5 and 14 and 15, the valve suture device 20 includes a handle 21, a clip module 23, a sheath 233, a needle module 25, a probe 260 and a suture (not shown). The operating handle 21 includes a housing 210 and a rotating spindle assembly 220, the rotating spindle assembly 220 extending axially within the housing 210 and having a distal end extending beyond the housing 210. The sheath 233 is fixedly attached to the distal end of the rotating mandrel assembly 220 and extends axially. The chuck module 23 comprises a proximal chuck 231 fixedly connected with the distal end of the sheath 233, a distal chuck 235 capable of opening and closing relative to the proximal chuck 231, and a chuck push tube 230 fixedly connected with the distal chuck 235 and movably inserted into the sheath 233 and the rotating mandrel assembly 220, wherein the length of the chuck push tube 230 is far greater than the outer diameter thereof, and the chuck push tube belongs to an elongated member. The pin module 25 includes pins 250 movably inserted into the sheath 233 and the rotating mandrel assembly 220, and the length of the pins 250 is far greater than the diameter thereof, which is an elongated member. The probe 260 is movably mounted within the sheath 233 and the rotating mandrel assembly 220, and the length of the probe 260 is substantially greater than its diameter, which is an elongate member. In this embodiment, suture 2337 is movably threaded into collet push tube 230, and the distal end of suture 2337 is received within distal collet 235. The proximal clamp 231 and the distal clamp 235 are opened and closed relative to each other for clamping or releasing the leaflet, and the probe 260 can extend out of the proximal clamp 231 for detecting whether the leaflet is effectively clamped by the clamp module 23, and the pin 250 is used to pierce the valve and bring out the suture 2337 for implanting the suture 2337 into the leaflet. In other embodiments, the suture 2337 may not be threaded into the collet push tube 230, but rather a separate lumen or tube for threading the suture may be provided within the sheath 233.

The adjustable curved sheath 30 is sleeved outside the sheath tube 233 of the valve suture device 20, and the curved state of the sheath tube 233 is adjusted by the adjustable curved sheath device 30 so as to adapt to the curved human body lumen structure.

The fixture 50 comprises a base 501, a first supporting frame 502 and a second supporting frame 504 which are arranged at two opposite ends of the base 501, wherein the shell 210 of the control handle 21 of the valve suture device 20 is fixed on the first supporting frame 502, the handle (not labeled) of the adjustable curved sheath 30 is fixed on the second supporting frame 504, and an operator does not need to hold the control handle 21 of the valve suture device 20 and the handle of the adjustable curved sheath 30 by hands, so that the valve suture device 20 and the adjustable curved sheath 30 are labor-saving and stable.

Referring to fig. 1, 3, 14, 15 and 16-22, the control handle 21 further includes a chuck opening and closing control module 216, a pin locking and unlocking control module 217 and a probe movement control module 218, which are disposed on the housing 210. The distal end and the proximal end of the chuck push tube 230 are connected to the distal chuck 235 and the chuck opening and closing control module 216 respectively; the proximal end of the pin 250 is connected to the pin lock control module 217; the proximal end of the probe 260 is connected to the probe motion control module 218. The chuck opening and closing control module 216 includes a chuck opening and closing operation member 2160, the pin lock release control module 217 includes a pin lock release operation member 2170, the probe movement control module 218 includes a probe movement operation member 2180, and the chuck opening and closing operation member 2160, the pin lock release operation member 2170 and the probe movement operation member 2180 are disposed on the front surface of the housing 210 facing the operator. The chuck opening and closing operation member 2160 is used for controlling the axial movement of the chuck push tube 230, the pin lock and release operation member 2170 is used for locking or releasing the pin module 25 to restrict or allow the axial movement of the pins 250, and the probe movement operation member 2180 is used for controlling the axial movement of the probes 260.

As shown in fig. 5, 6, 7 and 12, in this embodiment, the sheath 233 is internally provided with elongated members such as a collet push tube 230, a pin 250, a probe 260, and a guide wire 201 extending in the axial direction. The sheath 23 needs to travel in the blood vessel of the human body, and therefore, the inner diameter size of the sheath is very limited, so that the space between the elongated members such as the chuck push tube 230, the contact pin 250, the probe 260 is relatively small, if the chuck push tube 230, the contact pin 250 and the probe 260 are respectively connected with the chuck opening and closing control module 216, the contact pin locking and unlocking control module 217 and the probe movement control module 218, the space between the elongated members is small, on one hand, the installation and operation are inconvenient, the control and the movement of the elongated members can interfere with each other, and on the other hand, the chuck opening and unlocking control module 216, the contact pin locking and unlocking control module 217, the probe movement control module 218 and the whole control handle 21 need to be designed to be smaller in size, so that the processing and assembling difficulty is increased. The present application provides the rotating spindle assembly 220 to address this technical problem.

As shown in fig. 4, 5, 6-11, 13 and 14, the rotary mandrel assembly 220 includes a rotary mandrel 221, a transition guide portion 2210 is disposed at a distal end of the rotary mandrel 221, a distal end of the transition guide portion 2210 is adjacent to a proximal end of the sheath 233, a cross-sectional area of the transition guide portion 2210 perpendicular to the axial direction is gradually increased from the distal end to the proximal end, a plurality of channels spaced from each other and penetrating the proximal end and the distal end of the transition guide portion 2210 are formed on an outer surface of the transition guide portion 2210, so as to respectively allow a plurality of elongated members such as the collet pushing tube 230, the insertion needle 250, the probe 260 to correspondingly penetrate therethrough, such that the plurality of elongated members relatively gather at the distal end of the transition guide portion 2210 and relatively diffuse at the proximal end of the transition guide portion 2210. The space between the plurality of elongated members diffused by the transition guide 2210 increases, so that the plurality of elongated members facilitate connection with the corresponding motion control modules on the steering handle 21, i.e., installation to the steering handle 21; the channels are mutually isolated, so that the elongated members can be controlled independently and are not interfered with each other, and the elongated members can move smoothly; meanwhile, the size of each motion control module can be designed to be relatively large, and the processing and assembling difficulty can be greatly reduced.

Specifically, referring to fig. 6 to 11, in the present embodiment, the outer surface of the transition guide portion 2210 is provided with a collet push tube channel 2212, a pin channel 2214 and a probe channel 2215 that are spaced apart from each other, and further, a wire guide channel 2211 is axially provided inside the transition guide portion 2210. The guide wire 201 is movably inserted in the guide wire channel 2211, the chuck push tube 230 is movably inserted in the chuck push tube channel 2212, the pin 250 is movably inserted in the pin channel 2214, the probe 260 is movably inserted in the probe channel 2215, the chuck push tube 230, the pin 250 and the probe 260 are gathered relatively at the far end of the transition guide portion 2210 and are diffused relatively and isolated mutually at the near end of the transition guide portion 2210, and the guide wire 201, the chuck push tube 230, the pin 250 and the probe 260 can be controlled independently and are not interfered mutually, so that the control is convenient.

The rotating mandrel 221 further includes a shaft 2218 axially disposed proximal to the transition guide 2210, and a guidewire channel 2211, a collet pusher channel 2212, a pin channel 2214, and a probe channel 2215 all axially extend through the transition guide 2210 and the shaft 2218.

Further, transition guide 2210 includes a frustum with a diameter that increases from the distal end to the proximal end. In this embodiment, the frustum is a cone, the shaft 2218 is a cylinder, the axis of the frustum coincides with the axis of the shaft 2218, and the diameter of the proximal end surface of the frustum is the same as the diameter of the distal end surface of the shaft 2218. The guidewire channel 2211, collet pusher channel 2212, pin channel 2214, and probe channel 2215 extend from the distal face of the transition guide 2210 to the proximal end of the shaft 2218.

In this embodiment, it is preferable that the guide wire passage 2211 is passed through the rotary mandrel 221 along the axis of the rotary mandrel 221, that is, the guide wire passage 2211 is passed through the transition guide 2210 and the shaft 2218 along the axis of the rotary mandrel 221. The portions of the collet push tube passage 2212, the pin passage 2214, and the probe passage 2215 corresponding to the shaft 2218 pass through the outer surface and/or the proximal end surface of the shaft 2218. The collet push tube channel 2212, the pin channel 2214 and the probe channel 2215 are circumferentially and alternately distributed on the outer surface of the transition guide portion 2210, and the collet push tube channel 2212, the pin channel 2214 and the probe channel 2215 penetrate through the distal end surface and the proximal end surface of the transition guide portion 2210. Preferably, the collet push tube passage 2212, the pin passage 2214, and the probe passage 2215 are uniformly circumferentially arranged.

As shown in fig. 4, 5, 8-10 and 13, the collet push tube channel 2212 includes a first distal end guiding groove 22121 formed on an outer surface of the transition guiding portion 2210, a first middle guiding hole 22123 axially penetrating the distal end of the shaft 2218, and a first proximal end guiding groove 22125 communicating with the first middle guiding hole 22123 and axially penetrating the outer surface and the proximal end surface of the shaft 2218, and the collet push tube 230 is slidably received in the first distal end guiding groove 22121, the first middle guiding hole 22123 and the first proximal end guiding groove 22125. The pin channel 2214 includes a second distal guiding groove 22141 formed on an outer surface of the transition guiding portion 2210, and a guiding hole 22143 communicating with the second distal guiding groove 22141 and axially penetrating the shaft 2218, and the pin 250 is slidably received in the second distal guiding groove 22141 and the guiding hole 22143. The probe passage 2215 includes a third distal guide groove 22151 formed in an outer surface of the transition guide portion 2210, a second middle guide hole 22153 communicating with the third distal guide groove 22151 and axially penetrating the distal end of the shaft 2218, and a second proximal guide groove 22155 communicating with the second middle guide hole 22153 and axially penetrating the outer surface and the proximal end surface of the shaft 2218, and the probe 260 is slidably received in the third distal guide groove 22151, the second middle guide hole 22153, and the second proximal guide groove 22155.

The distal end of the transition guide 2210 extends distally from one side of the guidewire channel 2211 to a support block 22101, and the support block 22101 is used for carrying the guidewire 201. Specifically, the support block 22101 extends distally from a distal end face of the transition guide 2210 away from a side of the probe passage 2215, and distal ends of the guidewire passage 2211 and the collet pusher passage 2212 extend axially and pass through the distal end face of the support block 22101.

Preferably, two pins 250 and two probes 260 are disposed in the valve suture device 20, two pin passages 2214 and two probe passages 2215 are disposed on the outer surface of the transition guide portion 2210 and spaced apart from each other, the two pin passages 2214 are symmetrical with respect to the axis of the transition guide portion 2210, and the two probe passages 2215 are symmetrical with respect to the axis of the transition guide portion 2210.

Referring to fig. 3 to 5 and fig. 11 and 13, the rotating mandrel assembly 220 further includes a rotating operation mechanism 223, and the rotating mandrel 221 is circumferentially provided with a positioning ring 22103 at the intersection of the transition guiding portion 2210 and the shaft 2218, wherein the positioning ring 22103 is used for positioning the rotating operation mechanism 223. The rotary operation mechanism 223 includes a sealing shell 2232 sleeved on the transition guiding portion 2210, a connecting cylinder 2234 sleeved on the sealing shell 2232, a rotary cover 2235 sleeved on the connecting cylinder 2234, and a fixed cover 2236 sleeved on the shaft 2218 and adjacent to the proximal end of the positioning ring 22103, wherein the sealing shell 2232 is fixedly connected to the transition guiding portion 2210, and an inner surface of the sealing shell 2232 is attached to an outer surface of the transition guiding portion 2210. The connection cylinder 2234 is fixedly connected to the seal housing 2232, the rotary cap 2235 is fixedly connected to the connection cylinder 2234, and the fixed cap 2236 is connected to the proximal end of the seal housing 2232 and abuts the positioning ring 22103.

Specifically, the seal housing 2232 includes a seal cylinder 22321 and a connecting cylinder 22323 axially disposed at a proximal end of the seal cylinder 22321, wherein the seal cylinder 22321 has a tapered cylindrical shape, an inner circumferential surface thereof is attached to an outer surface of the transition guide portion 2210, and a distal end of the seal cylinder 22321 is sealed with a proximal end of the connecting sheath 233 by injecting glue or other means. The outer surface of the proximal end of the connecting cylinder 22323 is provided with external threads. A plurality of clamping rings 22324 are circumferentially arranged on the outer surface of the connecting cylinder 22323 adjacent to the external thread, and a plurality of clamping grooves 22326 are axially formed on the clamping rings 22324.

The inner circumferential surface of the seal shell 2232 is provided with a plurality of protruding strips (not shown), which can cover the first distal end guiding groove 22121, the second distal end guiding groove 22141 and the third distal end guiding groove 22151 of the transition guiding portion 2210, respectively, so that the portions of the channels corresponding to the transition guiding portion 2210 are circumferentially closed, to prevent the collet push tube 230, the pin 250 and the probe 260 from being separated from the first distal end guiding groove 22121, the second distal end guiding groove 22141 and the third distal end guiding groove 22151.

The sealing shell 2232 and the connecting cylinder 2234 are respectively provided with a positioning groove and a positioning strip which are mutually matched and extend along the axial direction; the connecting cylinder 2234 and the rotary cover 2235 are respectively provided with a positioning groove and a positioning strip which are mutually matched and extend along the axial direction.

The connecting barrel 2234 includes a distal tapered barrel 22341 and a proximal barrel 22343 axially disposed on the distal tapered barrel 22341. When the connection cylinder 2234 is sleeved on the seal shell 2232, the inner circumferential surface of the distal cone 22341 corresponds to the outer surface of the seal cylinder 22321, and the inner circumferential surface of the proximal cylinder 22343 corresponds to the outer surface of the connection cylinder 22323. The inner circumferential surface of the proximal cylinder 22343 is provided with a positioning strip 22346 corresponding to the snap groove 22326 of the seal housing 2232. The outer surface of the proximal barrel 22343 is provided with a plurality of detents 22347, a plurality of detents 22347 are arrayed circumferentially about the proximal barrel 22343, and each detent 22347 extends axially.

The rotary cap 2235 is a cylindrical body, and when the rotary cap 2235 is coupled to the proximal cylinder 22343 of the connection cylinder 2234, the inner circumferential surface of the rotary cap 2235 is bonded to the outer surface of the proximal cylinder 22343. The inner peripheral surface of the rotary cover 2235 is provided with a plurality of positioning strips 22352 corresponding to the positioning grooves 22347 of the connecting cylinder 2234, and the plurality of positioning strips 22352 are respectively clamped in the corresponding positioning grooves 22347 so as to realize the connection between the rotary cover 2235 and the connecting cylinder 2234. A rotating guide groove 2231 is circumferentially provided at a proximal end of an outer surface of the rotating cover 2235, and an axis of the rotating guide groove 2231 coincides with an axis of the rotating cover 2235.

The fixed housing cover 2236 is a cylinder, and the distal end of the inner circumferential surface of the fixed housing cover 2236 is provided with an internal thread corresponding to the external thread of the sealing housing 2232, and the diameter of the proximal end port of the fixed housing cover 2236 is smaller than the outer diameter of the positioning ring 22103, so that the proximal end of the fixed housing cover 2236 can be stopped at the positioning ring 22103. The internal and external screw threads fixedly connect the seal housing 2232 to the mandrel 221. Since the seal shell 2232 and the connecting cylinder 2234 and the rotating cover 2235 are connected with the positioning strips through the mutually matched positioning grooves extending along the axial direction, the rotating cover 2235 can drive the connecting cylinder 2234, the seal shell 2232 and the rotating mandrel 221 to synchronously rotate.

As shown in fig. 4, 5, 14, 15, and 16-19, the rotating spindle assembly 220 further includes a first collar 2256 slidably disposed over the shaft 2218 adjacent the rotating operation 223, the first collar 2256 being slidable along the axial direction of the rotating spindle 221. The outer wall of the first collar 2256 is circumferentially provided with an annular first annular groove 22561. The inner wall of the first collar 2256 is provided with a first lug 22563 slidably inserted into the first proximal end guide groove 22125 of the collet push tube channel 2212, the proximal end of the collet push tube 230 is fixedly connected to the first lug 22563, and the first collar 2256 is connected to the collet opening and closing control module 216 through the first ring groove 22561, so that the collet push tube 230 inserted into the push tube channel 2212 is conveniently connected to the collet opening and closing control module 216 through the first collar 2256 due to the diffusion of the transition guide 2210. When the collet opening and closing operation member 2160 is operated to drive the first collar 2256 to slide along the shaft 2218, the collet push tube 230 is driven to move along the collet push tube passage 2212, the distal collet 235 is driven by the collet push tube 230 to move distally away from the proximal collet 231 to open or the distal collet 235 is driven by the collet push tube 230 to move proximally to close to the proximal collet 231 to close.

As shown in fig. 4, 5, 14, 15, and 16-19, the rotating mandrel assembly 220 further includes at least one second collar 2257 slidably sleeved on the shaft 2218, wherein the second collar 2257 is slidable along the axial direction of the rotating mandrel 221. The outer wall of the second collar 2257 is circumferentially provided with an annular second annular groove 22571. The inner wall of the second collar 2257 is provided with a second ledge 22573 slidably inserted into the second proximal guide slot 22155 of the probe passage 2215, and the proximal end of the probe 260 is fixedly attached to the second ledge 22573. The second collar 2257 is connected to the probe movement control module 218 through the second ring groove 22571, so that the probe 260 inserted in the probe passage 2215 is conveniently connected to the probe movement control module 218 through the second collar 2257 due to the diffusion of the transition guide 2210. When the probe movement operator 2180 is operated to drive the second collar 2257 to slide along the shaft 2218, the probe 260 is moved along the probe passage 2215 so that the probe 260 is extended or retracted into the proximal collet 231 to detect whether the valve leaflet is effectively gripped by the collet module 23. In this embodiment, two probes 260 are disposed, two second collars 2257 are correspondingly sleeved on the rotating mandrel 221, two probes 260 are respectively accommodated in the two probe passages 2215, and the proximal end of one probe 260 is correspondingly and fixedly connected with a second lug 22573 of the second collar 2257.

As shown in fig. 4, 5, 14, 15, and 20-22, the rotating mandrel assembly 220 further includes a pin handle 251 slidably disposed over the proximal end of the shaft 2218, the pin handle 251 being slidable along the axis of the rotating mandrel 221. The proximal end of the pin 250 is fixedly connected to a pin handle 251. The outer wall of the distal end of the pin handle 251 is circumferentially provided with a positioning ring groove 2512, and the pin handle 251 is connected to the pin lock control module 217 through the positioning ring groove 2512, so that the pin 250 inserted into the pin passage 2214 is conveniently connected to the pin handle 251 due to the diffusion effect of the transition guide 2210 and is conveniently connected to the pin lock control module 217 through the positioning ring groove 2512 of the pin handle 251. When the pin lock release operation member 2170 is operated to enable the pin lock release control module 217 to release the pin handle 251, the pin handle 251 can be moved axially to drive the pin 250 to advance or retract, so as to puncture the valve leaflet or pull out the suture; when the pin lock release operator 2170 is operated such that the pin lock release control module 217 locks the pin handle 251, the pin 250 may be maintained within the proximal grip 231. In this embodiment, the number of pins 250 is two, and both pins 250 can be fixedly connected to the pin handle 251 through a locking member or directly.

Referring to fig. 4 to 10, 12, 16, 18 and 20, the proximal ends of the collet push tube 230, the pin 250 and the probe 260, which are integrally inserted into the sheath 233, are inserted into the collet push tube channel 2212, the pin channel 2214 and the probe channel 2215 from the distal end of the transition guide 2210. Specifically, the proximal end of the collet push tube 230 sequentially passes through the first distal guide slot 22121 and the first middle guide hole 22123, extends to the first proximal guide slot 22125, and is fixedly connected to the first collar 2256; the proximal end of the pin 250 sequentially passes through the second distal end guiding groove 22141 and the guiding hole 22143, extends out of the proximal end surface of the shaft 2218 and is fixedly connected with the pin handle 251; the proximal end of the probe 260 passes through the third distal guide slot 22151, the second central guide hole 22153 in sequence, extends into the second proximal guide slot 22155 and is fixedly attached to the second collar 2257. The seal shell 2232 is sleeved on the transition guiding portion 2210, the connecting cylinder 2234 is sleeved on the seal shell 2232, the rotating cover 2235 is sleeved on the connecting cylinder 2234, the fixed cover 2236 is sleeved on the shaft 2218 from the proximal end of the shaft 2218, the internal thread of the fixed cover 2236 is in threaded connection with the external thread of the seal shell 2232, and the fixed cover 2236 abuts against the positioning ring 22103, so that the rotating operation mechanism 223 is positioned on the rotating mandrel 221. The proximal end of the guidewire 201 passes through the guidewire channel 2211.

Referring to fig. 3, 5, 14 and 16-22, the chuck opening and closing operation member 2160 is used for controlling the chuck push tube 230 to move axially, the pin locking operation member 2170 is used for locking or releasing the pin handle 251 to limit or allow the pin 250 to move axially, and the probe movement operation member 2180 is used for controlling the probe 260 to move axially. The chuck opening and closing operation member 2160, the pin lock releasing operation member 2170 and the probe moving operation member 2180 are all located on the front surface of the housing 210, and the rotating mandrel assembly 220 is rotationally connected with the housing 210, the chuck opening and closing control module 216, the pin lock releasing control module 217 and the probe moving control module 218, the chuck opening and closing operation member 2160, the probe moving operation member 2180 and the pin lock releasing operation member 2170 on the front surface of the housing 210 and the housing 210 cannot rotate together with other components and always face the operator, so that the operator can conveniently and quickly operate the chuck opening and closing operation member 2160, the probe moving operation member 2180 and the pin lock releasing operation member 2170 to drive the opening and closing of the chuck module 23, the extension or retraction of the probe 260 and the locking or releasing of the pin handle 251 through the chuck opening and closing control module 216, the probe moving control module 218 and the pin lock releasing control module 217 respectively; in addition, when the sheath 233 and the collet module 23 are required to be rotated to change the opening direction of the collet module 23 to clamp different valve leaflets, only the rotating mandrel assembly 220 is required to be rotated, and the whole control handle 21 and the whole valve suture device 20 are not required to be rotated, so that the operation is more convenient. It can be seen that the valve suture instrument 20 and the operating interface of the operating handle 21 thereof (the front surface of the housing 210 of the operating handle 21 and the collet opening and closing operating member 2160, the probe moving operating member 2180 and the pin locking and unlocking operating member 2170, which may be referred to as an operating interface) are convenient and friendly for the operator.

Specifically, as shown in fig. 3 to 5 and 14 to 15, the housing 210 includes a first housing 211 and a second housing 213 aligned with the first housing 211. The face of the first housing 211 facing away from the second housing 213 is a front face 2110, and the collet opening and closing operator 2160, the pin lock release operator 2170, and the probe movement operator 2180 are all located on the front face 2110. Preferably, the first housing 211 is snapped or bonded to the second housing 213 to form a tubular-like structure open at both ends, and the rotating mandrel assembly 220 extends axially within the tubular-like structure. The chuck opening and closing control module 216 is disposed at a distal end in the first housing 211, the pin locking and unlocking control module 217 is disposed at a proximal end in the first housing 211, and the probe movement control module 218 is disposed in the first housing 211 and between the chuck opening and closing control module 216 and the pin locking and unlocking control module 217. A first distal end wall 2111 of a semicircular arc is provided circumferentially at the distal end edge of the first housing 211, and a first proximal end wall 2113 of a semicircular arc is provided circumferentially at the proximal end edge of the first housing 211; the distal edge of the second housing 213 is circumferentially provided with a semicircular second distal wall 2131 and the proximal edge of the second housing 213 is circumferentially provided with a semicircular second proximal wall 2133; when the first housing 211 and the second housing 213 are mated, the first distal wall 2111 and the second distal wall 2131 form an annular end wall at the distal end of the housing 210, and the first proximal wall 2113 and the second proximal wall 2133 form an annular end wall at the proximal end of the housing 210. The annular end wall at the distal end of the housing 210 is embedded in a rotating guide groove 2231 provided on the rotating cover 2235, and the annular end wall at the proximal end of the housing 210 is embedded in a rotating guide groove 2531 circumferentially provided on the outer wall of the pin handle 251, so that a rotating connection is formed between the rotating mandrel assembly 220 and the housing 210, and the rotating operating mechanism 223 is rotated clockwise or anticlockwise at any angle relative to the housing 210, so that the whole rotating mandrel assembly 220 can be driven to rotate clockwise or anticlockwise at any angle.

As shown in fig. 1, 3,4, 14, and 15 to 17, the chuck opening and closing control module 216 further includes a first connector 2161 rotatably connected to the first collar 2256 and a first transmission assembly 2166 connected between the chuck opening and closing operating member 2160 and the first connector 2161, and the first transmission assembly 2166 is configured to convert rotation of the chuck opening and closing operating member 2160 into axial movement of the first connector 2161, so as to drive the first collar 2256 and the chuck push tube 230 to move axially, thereby driving the chuck module 23 to clamp or unclamp the valve leaflet.

Specifically, the first connector 2161 includes a first connection tab 21611 that rotatably connects to the first collar 2256. The first connecting piece 21611 faces to one side of the first collar 2256 and is provided with an arc-shaped opening 21612, and the inner wall of the opening 21612 of the first connecting piece 21611 is embedded into the first annular groove 22561 of the first collar 2256, so that the first connecting piece 2161 is rotationally connected with the first collar 2256, and the rotational connection of the rotational mandrel assembly 220 and the chuck opening and closing control module 216 is realized.

In this embodiment, the first transmission assembly 2166 includes a first bevel gear 21675 connected to the chuck opening and closing operator 2160, a second bevel gear 21682 axially perpendicular to the first bevel gear 21675 and meshed with each other, and a screw rod 21684 coaxially connected to the second bevel gear 21682, the screw rod 21684 is adapted to be connected to a screw hole 21615 provided on the first connector 2161, and the axial directions of the second bevel gear 21682 and the screw rod 21684 are parallel to the axial direction of the rotary spindle 221. Rotating the chuck opening and closing member 2160 drives the first bevel gear 21675 to rotate, the second bevel gear 21682 and the lead screw 21684 to rotate, the lead screw 21684 rotates to drive the first connector 2161 to axially move, and the first connector 2161 drives the first collar 2256 and the chuck push tube 230 to axially move.

Referring to fig. 1,3, 4, 5, 14, 15 and 20 to 22, the pin control module 217 further includes a locking member 2171, a pushing member 2174 disposed between the pin lock release operation member 2170 and the locking member 2171, and an elastic member 2176 abutting between the pushing member 2174 and the housing 210 to force the locking member 2171 to reset. The locking member 2171 is used for locking or releasing the pin handle 251, i.e. the pin lock release operation member 2170 pushes the pushing member 2174 to drive the locking member 2171 to move to lock or release the pin handle 251, and the elastic member 2176 is used for resetting the movement of the locking member 2171; when the locking member 2171 locks the pin handle 251, the locking member 2171 is rotatably connected to the pin handle 251, i.e., the rotational connection of the rotating spindle assembly 220 to the pin control module 217 is achieved.

Specifically, the locking member 2171 includes a supporting rod 2172 and at least one locking rod 2173 connected to the supporting rod 2172, and the pushing member 2174 abuts against the supporting rod 2172, so that the end of the at least one locking rod 2173 away from the supporting rod 2172 is locked or released from the contact pin handle 251.

Specifically, two opposite ends of the abutting rod 2172 are respectively provided with a locking rod 2173, one end of each locking rod 2173 far away from the abutting rod 2172 is provided with a locking block 2175, the elastic piece 2176 abuts against the locking block 2175, and the locking block 2175 can be inserted into the positioning ring groove 2512 of the pin handle 251, and at the moment, the pin handle 251 can be prevented from moving axially; the pin handle 251 is locked or released by pressing the pin lock release operator 2170 such that the locking block 2175 is inserted into the retention ring groove 2512 or is disengaged from the retention ring groove 2512. The spacing between the two locking bars 2173 is greater than the outer diameter of the locating ring groove 2512 of the pin handle 251, and when the locating ring groove 2512 is fully located between the two locking bars 2173, the pin handle 251 can rotate and move axially between the two locking bars 2173; the space between the two locking blocks 2175 is smaller than the outer diameter of the positioning ring groove 2512, and the two locking blocks 2175 can be inserted into the positioning ring groove 2512; when two locking blocks 2175 are inserted into the positioning ring groove 2512, the pin handle 251 cannot move in the axial direction and can only rotate. The elastic member 2176 is disposed at an end of the locking lever 2173 remote from the abutting lever 2172.

It will be appreciated that the construction of the push member 2174 and the contact pin lock release operation member 2170 is similar to that of an automatic ballpoint pen. When the contact pin locking operation member 2170 is pressed down, the pushing member 2174 is pushed down to drive the locking member 2171 to move down, the elastic member 2176 is pressed by the locking member 2171 to generate elastic deformation, the locking block 2175 moves down to release the limit of the positioning ring groove 2512, and the contact pin handle 251 is unlocked; when the pin lock release operation member 2170 is not pressed or pressed again, the lock release operation member 2170 is reset to the initial position, the elastic member 2176 restores the initial state and pushes the lock block 2175 up to be caught in the positioning ring groove 2512, and the lock member 2171 locks the pin handle 251, and the locked state is normal.

Referring to fig. 1, 3, 4, 5, 14, 15, 18 and 19, the probe movement control module 218 further includes a second connecting member 2182 rotatably connected to the second collar 2257, and a second transmission member 2184 connected between the second connecting member 2182 and the probe movement operating member 2180. The second transmission assembly 2184 converts the movement of the probe moving operator 2180 into the axial movement of the second connector 2182 to drive the second collar 2257 and the probe 260 to move axially. The second connector 2182 is inserted into the second annular groove 22571 of the second collar 2257 such that the second connector 2182 is in rotational connection with the second collar 2257, i.e., establishes a rotational connection of the rotating mandrel assembly 220 with the probe movement control module 218. The probe movement operator 2180 is operated to control the second transmission assembly 2184 to move the second collar 2257 axially to move the probe 260 axially.

Specifically, the second transmission assembly 2184 includes a fixed frame 2185 fixed in the housing 210, a sliding member 2186 axially slidably disposed on the fixed frame 2185, and a locking member 2187 connected between the probe moving operation member 2180 and the sliding member 2186. Moving the probe moving operation member 2180 can drive the sliding member 2186 to axially slide, so as to drive the second connecting member 2182 to axially move, and the axial movement of the second connecting member 2182 can drive the second collar 2257 and the probe 260 to axially move. The locking member 2187 can be locked with the housing 210, when the probe moving operation member 2180 is pressed, the locking member 2187 can be separated from the lock with the housing 210, and then the probe moving operation member 2180 can drive the second connecting member 2182 to move; when the probe movement manipulation member 2180 is moved proximally to the proximal limit position, the locking member 2187 again latches with the housing 210 such that the distal end of the probe 260 remains retracted within the proximal collet 231, preventing inadvertent movement of the probe movement manipulation member 2180 when it is not desired to extend the distal end of the probe 260 beyond the proximal collet 231.

Specifically, the side of the second connecting member 2182 facing the second collar 2257 is provided with an arc-shaped opening 21820, and an inner wall of the opening 21820 of the second connecting member 2182 is rotatably received in the second annular groove 22571 of the corresponding second collar 2257.

Referring to fig. 5, 14, 16 and 17, when the chuck module 23 is controlled by the chuck opening/closing control module 216, the distal chuck 235 is controlled to be opened or closed by the chuck opening/closing control module 216 cooperating with the chuck module 23. The rotating chuck opening and closing operation member 2160 can drive the first bevel gear 21675 to rotate, the first bevel gear 21675 drives the screw rod 21684 to rotate through the second bevel gear 21682, the rotation of the screw rod 21684 drives the first connecting piece 21611 to axially move, and the first connecting piece 21611 drives the first collar 2256 and the chuck push tube 230 connected to the first collar 2256 to axially move, so that the distal chuck 235 is far away from or near the proximal chuck 231, and the distal chuck 235 and the proximal chuck 231 can be opened or closed.

Referring to fig. 5, 14, 18 and 19, in the initial state, the locking member 2187 of the probe movement control module 218 is locked to the first housing 211, the probe movement operating member 2180 is located at the proximal limit position, and the distal end of the probe 260 is retracted into the proximal chuck 231. When the probe moving operation member 2180 is pressed, the locking member 2187 is disengaged from the first housing 211, and then the probe moving operation member 2180 is pushed to the distal end to drive the second connecting member 2182 to move axially and distally, and the second connecting member 2182 drives the corresponding second collar 2257 to move axially and distally along the rotating mandrel 221, so that the probe 260 moves axially and distally, and the distal end of the probe 260 extends out of the proximal chuck 231 to detect whether the valve leaflet is effectively clamped by the chuck module 23. Conversely, when the probe movement actuator 2180 is pulled proximally, the probe 260 is forced to move proximally until the lock 2187 is again latched to the first housing 211, at which point the distal end of the probe 260 is retracted into the proximal jaw 231.

Referring to fig. 5, 14, and 20-22, the pin lock control module 217 cooperates with the pin handle 251 to control the forward or backward movement of the pin 250. The pin handle 251 can drive the pin 250 to move along the axial direction, and the pin locking control module 217 is used for locking or unlocking the pin handle 251. When the pin lock control module 217 is in the initial position, the locking block 2175 is inserted into the positioning ring groove 2512 of the pin handle 251 to prohibit the pin handle 251 from moving in the axial direction, and at this time, the pin lock control module 217 is in the locked state. When the needle lock release operation member 2170 is pressed to move the pushing member 2174 downward, the pushing member 2174 pushes the locking member 2171 downward until the locking block 2175 is separated from the positioning ring groove 2512 of the needle handle 251, and the elastic member 2176 is elastically contracted under pressure, at this time, the needle lock release control module 217 is in an unlocked state, and the needle handle 251 can move axially to drive the needle 250 to move axially, so as to push or pull the needle forward or backward to puncture the leaflet to connect or take out the suture. The pin lock operation member 2170 is pressed again, the elastic member 2176 is elastically restored to push the lock 2171, the push member 2174, and the pin lock operation member 2170 to be restored, and the lock block 2175 is inserted again into the positioning ring groove 2512 of the pin handle 251 to lock the pin handle.

The use of the valve suture system 100 of the present invention is illustrated with respect to treating a tricuspid valve: the clip module 23 and the sheath 233 of the valve suture device 20 enter the right atrium through femoral vein and inferior vena cava routes, the distal clip 235 is controlled to be opened relative to the proximal clip 231 through the clip opening and closing operation member 2160, the clip module 23 is rotated by adjusting the bending degree of the distal end of the sheath 233 through the adjustable bending sheath 30 and/or rotating the rotating operation mechanism 223 when necessary, so that the opening direction of the clip module 23 faces to the valve leaflet to be clamped, and the distal clip 235 is controlled to be closed relative to the proximal clip 231 through the clip opening and closing operation member 2160 to clamp the valve; then pressing the probe moving operation member 2180, the probe 260 detects whether the valve is successfully clamped, if so, pressing the contact pin locking operation member 2170 to enable the locking member 2171 to release the lock catch of the contact pin handle 251, controlling the contact pin 250 to sequentially puncture the valve, draw out the suture and drive the suture to pass through the valve through the contact pin handle 251, and then fixing the suture to the ventricular wall or papillary muscle to achieve the effect of repairing chordae tendineae, or alternatively locking a plurality of sutures implanted into different valves together to achieve the effect of repairing edge to edge.

The collet module 23 and distal end of sheath 233 of the valve suture apparatus 100 of the present invention may also be passed through the fossa ovalis into the left atrium and ventricle to perform mitral valve repair.

The foregoing is a description of embodiments of the present invention, and it should be noted that, for those skilled in the art, modifications and variations can be made without departing from the principles of the embodiments of the present invention, and such modifications and variations are also considered to be within the scope of the present invention.

Claims

1. The utility model provides a rotatory dabber subassembly, its characterized in that is applied to the valve suture ware, the valve suture ware includes the sheath pipe and wears to adorn a plurality of elongate pieces in the sheath pipe, rotatory dabber subassembly includes rotatory dabber, the distal end of rotatory dabber is provided with transition guide portion, the distal end of transition guide portion is adjacent the proximal end of sheath pipe, the cross-sectional area that is perpendicular to axial of transition guide portion increases gradually from distal end to proximal end, the surface of transition guide portion sets up mutual interval and link up a plurality of passageway of proximal end and distal end of transition guide portion for respectively supply a plurality of elongate pieces to correspondingly alternate, make a plurality of elongate pieces in the distal end of transition guide portion gathers together relatively, in the proximal end of transition guide portion diffuses relatively.

2. The rotating mandrel assembly of claim 1, wherein the transition guide comprises a frustum, and wherein the diameter of the frustum increases from the distal end to the proximal end.

3. The rotating mandrel assembly of claim 1 or 2, wherein the plurality of elongated members comprise collet push tubes, pins, and probes, the plurality of channels comprising collet push tube channels, pin channels, and probe channels, the collet push tubes being interspersed within the collet push tube channels, the pins being interspersed within the pin channels, the probes being interspersed within the probe channels.

4. A rotary mandrel assembly according to claim 3 wherein the number of pins and pin channels is two, the number of probes and probe channels is two, the two pin channels are symmetrical about the axis of the rotary mandrel, and the two probe channels are symmetrical about the axis of the rotary mandrel.

5. The rotating mandrel assembly of claim 3, further comprising a shaft extending axially from a proximal end of the transition guide, the collet push tube channel, the pin channel, and the probe channel all extending axially through the shaft.

6. The rotating mandrel assembly of claim 5, wherein a guide wire channel is further provided within the rotating mandrel, the guide wire channel axially passing through the transition guide and the shaft, the guide wire channel being configured for insertion of a guide wire.

7. The rotating mandrel assembly of claim 5, wherein portions of the collet push tube channel, the probe channel, and the pin channel corresponding to the shaft pass through an outer surface and/or a proximal end surface of the shaft.

8. The rotating mandrel assembly of claim 7, further comprising a first collar slidably disposed over the shaft, a second collar fixedly coupled to the proximal end of the collet push tube for driving the collet push tube to move axially by axial sliding of the first collar, and a pin handle fixedly coupled to the proximal end of the pin for driving the pin to move axially by axial sliding of the second collar.

9. The rotating mandrel assembly of claim 8, wherein the first collar is provided with lugs extending into the collet push tube channel, the proximal end of the collet push tube being fixedly connected to lugs of the first collar; the second collar is provided with lugs extending into the probe channel, and the proximal end of the probe is fixedly connected to the lugs of the second collar; the contact pin handle is sleeved at the proximal end of the shaft lever.

10. The rotating mandrel assembly of claim 6, wherein a distal end of the transition guide extends beyond a side of the guidewire channel to form a cradle for supporting the guidewire.

11. The rotary spindle assembly of claim 1, further comprising a rotary actuator fixedly coupled to a distal end of the rotary spindle, rotation of the rotary actuator effecting rotation of the rotary spindle.

12. The rotating mandrel assembly of claim 11, wherein the rotating operating mechanism comprises a sealing shell sleeved on the transition guide portion, a connecting cylinder sleeved on the sealing shell, and a rotating cover sleeved on the connecting cylinder, the sealing shell is fixedly connected to the transition guide portion, the inner surface of the sealing shell is attached to the outer surface of the transition guide portion, the connecting cylinder is fixedly connected to the sealing shell, and the rotating cover is fixedly connected to the connecting cylinder.

13. The rotating mandrel assembly of claim 12, wherein the inner peripheral surface of the seal housing is provided with a plurality of ribs that respectively overlie each of the channels of the transition guide such that each of the channels is circumferentially closed.

14. The rotary mandrel assembly according to claim 12, wherein the sealing shell and the connecting cylinder are respectively provided with a positioning groove and a positioning strip which are mutually matched and extend along the axial direction; the connecting cylinder and the rotary cover are respectively provided with a positioning groove and a positioning strip which are mutually matched and extend along the axial direction.

15. A control handle, characterized by comprising a shell, a rotary mandrel assembly according to any one of claims 1-14 and a plurality of motion control modules, wherein the rotary mandrel assembly extends axially in the shell, the distal end of the transition guide part extends out of the shell, the plurality of motion control modules are arranged on the shell, and the plurality of elongated pieces are respectively connected with the corresponding motion control modules after being diffused by the transition guide part of the rotary mandrel.

16. The steering handle of claim 15, wherein each of said motion control modules comprises an operator, each of said operators being located on a front of said housing facing an operator; the rotary mandrel assembly is rotationally connected with the shell and each motion control module, so that the rotary mandrel module can rotate by any angle relative to the shell and each motion control module, and each operating piece always faces an operator.

17. The manipulation handle of claim 16 wherein said plurality of motion control modules comprises a collet opening and closing control module, a pin lock release control module and a probe movement control module, said collet opening and closing control module comprising a collet opening and closing operator, said pin lock release control module comprising a pin lock release operator, said probe movement control module comprising a probe movement operator, different ones of said operators being actuated to correspondingly control the motion of different ones of said elongated members.

18. A valve suture device comprising the steering handle of any one of claims 15-17, the sheath fixedly attached to the distal end of the rotating mandrel assembly, and the plurality of elongate members threaded within the sheath.

19. A valve suture system comprising the valve suture device of claim 18 and a clip securing the manipulation handle of the valve suture device.

20. The valve suture system of claim 19, further comprising an adjustable curved sheath disposed outside a sheath of the valve suture device for adjusting a curved state of the sheath.