CN111772873A

CN111772873A - Drive handle for delivering an implant and delivery system

Info

Publication number: CN111772873A
Application number: CN201910272202.4A
Authority: CN
Inventors: 程小明; 刘世红; 赵婧; 陈国明; 李�雨
Original assignee: Shanghai Microport Cardioflow Medtech Co Ltd
Current assignee: Shanghai Microport Cardioflow Medtech Co Ltd
Priority date: 2019-04-04
Filing date: 2019-04-04
Publication date: 2020-10-16
Also published as: WO2020200149A1

Abstract

The invention provides a driving handle for conveying an implant and a conveying system, which can control the movement of an outer tube at different speeds according to the requirements of actual operation. The driving handle comprises a handheld sleeve, a fixing piece, a first driving mechanism, a second driving mechanism and a gear switching mechanism; the fixing piece is movably arranged in the handheld sleeve in a penetrating way; the first driving mechanism, the second driving mechanism and the gear switching mechanism are arranged on the handheld sleeve; the driving handle is provided with a first working mode and a second working mode, and the gear shifting mechanism is used for limiting the driving handle to be in one of the first working mode and the second working mode; when the driving handle is in a first working mode, the first driving mechanism is matched with the fixing piece so as to drive the fixing piece to move along the axis of the handheld sleeve at a first speed; when the drive handle is in a second mode of operation, the second drive mechanism cooperates with the securing member to drive the securing member to move along the axis of the hand-held sleeve at a second speed, the second speed being less than the first speed.

Description

Drive handle for delivering an implant and delivery system

Technical Field

The invention relates to the technical field of medical instruments, in particular to a driving handle and a conveying system for conveying an implant.

Background

With the development of socio-economic and the aging of population, the incidence rate of valvular heart disease is obviously increased, and researches show that the incidence rate of valvular heart disease in the aged people over 75 years old is up to 13.3%. At present, the traditional surgical treatment is still the first treatment method for patients with severe valvular diseases, but for the patients with advanced age, complicated multiple organ diseases, chest-opening operation history and poor cardiac function, the traditional surgical treatment has high risk and high death rate, and some patients even have no operation chance. The transcatheter heart valve operation has the advantages of no need of thoracotomy, small wound, quick recovery of patients and the like, and is widely concerned by experts and scholars.

The transcatheter heart valve operation needs to be carried into an interventional catheter through a femoral artery, and a valve is conveyed to an aortic valve area to be opened, so that the implantation of a prosthetic valve is completed, and the function of the valve is recovered. The implantation of the valve is typically performed with the aid of a delivery system that does not leave the sheath carrying the valve and the handle that drives the movement of the sheath, and which plays a crucial role during the procedure. According to clinical requirements, when the valve is loaded before an operation, the handle is expected to realize quick withdrawal and slow advancement of the sheath tube so as to improve the loading efficiency and the loading success rate; in the process of valve implantation, in order to ensure the positioning accuracy, the slower the valve release speed is, the better the sheath tube withdrawal speed is; after the positioning is accurate, in order to avoid excessive blood pressure reduction, the valve needs to be quickly released, i.e. the sheath needs to be quickly withdrawn. For a retrievable valve, if retrieval and re-release are required during implantation, the faster the valve is retrieved, the more beneficial the procedure, i.e., the faster the sheath is advanced. Generally, different stages of the operation have different requirements for the fast and slow operation of the handle.

However, the conventional handle has a problem of low efficiency and accuracy in controlling the speed and position of the valve, and therefore, it is necessary to develop a drive handle capable of controlling the speed and position of the valve with high efficiency and accuracy.

Disclosure of Invention

The invention aims to provide a driving handle and a conveying system for conveying an implant, wherein the driving handle can control a sheath tube for conveying the implant to move quickly or slowly according to the requirement of an actual operation, so that more accurate positioning control and more efficient operation in the implant implantation process are realized, and the operation difficulty is reduced.

To achieve the above and other related objects, the present invention provides a driving handle for delivering an implant, comprising a hand-held sleeve, a fixing member, a first driving mechanism, a second driving mechanism and a shift switching mechanism; at least one part of the fixing piece is movably arranged in the handheld sleeve in a penetrating mode, and the first driving mechanism, the second driving mechanism and the gear switching mechanism are all arranged on the handheld sleeve;

the drive handle has a first operating mode and a second operating mode, and the shift-position switching mechanism is configured to define the drive handle as being in one of the first operating mode and the second operating mode; when the drive handle is in the first working mode, the first driving mechanism is configured to be matched with the fixing piece so as to drive the fixing piece to move along the axis of the handheld sleeve at a first speed; when the drive handle is in the second mode of operation, the second drive mechanism is configured to cooperate with the fixed member to drive the fixed member to move along the axis of the hand-held sleeve at a second speed, the second speed being less than the first speed.

Optionally, the driving handle further comprises a gear locking mechanism disposed on the handheld sleeve;

the range lock mechanism is configured to lock the second drive mechanism to the hand-held sleeve when the drive handle is in the first operating mode; the range lock mechanism is further configured to lock the first drive mechanism to the hand-held sleeve when the drive handle is in the second mode of operation.

Optionally, when the drive handle is in the first operating mode, the shift-position switching mechanism is further configured to lock the second drive mechanism with the hand-held sleeve; the shift position switching mechanism is further configured to lock the first drive mechanism to the hand sleeve when the drive handle is in the second operating mode.

Optionally, the shift position switching mechanism is movably disposed on the hand sleeve;

the shift-position switching mechanism has a first position and a second position; when the shift position switching mechanism is moved to the first position, the drive handle is limited to the first operating mode, and the shift position switching mechanism also locks the second drive mechanism with the hand-held sleeve;

the drive handle is further constrained to the second operating mode when the shift-position mechanism is moved to the second position, and the shift-position mechanism further locks the first drive mechanism to the grip sleeve.

Optionally, the shift switching mechanism includes a switch movably disposed on the hand-held sleeve and located between the first driving mechanism and the second driving mechanism, and the switch and the hand-held sleeve are kept circumferentially relatively stationary;

when the change-over switch moves to the first position towards the second driving mechanism, the change-over switch is matched with the second driving mechanism, the second driving mechanism is locked with the handheld sleeve, and the driving handle is limited in a first working mode;

when the change-over switch moves towards the first driving mechanism to the second position, the change-over switch is matched with the first driving mechanism, the first driving mechanism and the handheld sleeve are locked, and the driving handle is limited in a second working mode.

Optionally, the first driving mechanism includes a first knob sleeved on the handheld sleeve, the second driving mechanism includes a second knob sleeved on the handheld sleeve, and both the first knob and the second knob and the handheld sleeve keep relatively stationary in the axial direction; wherein:

a first limiting part is arranged on one side, facing the second knob, of the first knob, and a third limiting part is arranged on the switch; the first limiting part is used for being matched with the third limiting part so as to limit the first knob to move in the circumferential direction of the handheld sleeve;

the second knob is provided with a second limiting part towards one side of the first knob, a fourth limiting part is further arranged on the switch, and the second limiting part is used for being matched with the fourth limiting part to limit the circumferential movement of the handheld sleeve of the first knob.

Optionally, the first limiting portion is a first limiting groove extending axially, the first limiting groove is not communicated with the inside of the first knob, and the third limiting portion is a first limiting protrusion;

the second limiting portion is a second limiting groove extending axially, the second limiting groove is not communicated with the inside of the second knob, and the fourth limiting portion is a second limiting protrusion.

Optionally, the change-over switch is of a sleeve structure and is movably sleeved between the first knob and the second knob, and the change-over switch and the handheld sleeve are coaxial;

the first knob is provided with a first cylindrical section and a third cylindrical section, the diameter of the third cylindrical section is smaller than that of the first cylindrical section, and the third cylindrical section is used for sleeving the selector switch;

the second knob is provided with a second cylindrical section and a fourth cylindrical section, the diameter of the fourth cylindrical section is smaller than that of the second cylindrical section, and the fourth cylindrical section is used for sleeving the selector switch;

wherein: the distance that the change-over switch moves from the second position to the first position is less than the length of the third cylindrical section, and the distance that the change-over switch moves from the first position to the second position is less than the length of the fourth cylindrical section.

Optionally, a fifth limiting part is arranged on the change-over switch, and a sixth limiting part is arranged on the handheld sleeve; the sixth limiting part is used for being matched with the fifth limiting part to limit the movement of the change-over switch in the circumferential direction of the handheld sleeve.

Optionally, the fifth limiting portion is a protrusion, the protrusion is symmetrically arranged and is a plurality of, the sixth limiting portion is a hollow limiting groove, and all protrusions are used for being inserted into the corresponding limiting grooves, so that the switch moves along the limiting grooves.

Optionally, the driving handle further comprises a first connecting piece and a second connecting piece arranged on the handheld sleeve, and the first connecting piece and the second connecting piece are at least axially kept relatively static with the handheld sleeve; wherein: the first connecting piece is used for limiting the movement of the first driving mechanism in the axial direction of the handheld sleeve; the second connecting piece is used for limiting the movement of the second driving mechanism in the axial direction of the handheld sleeve.

Optionally, the first connecting piece includes a first connecting ring sleeved on the handheld sleeve, and the second connecting piece includes a second connecting ring sleeved on the handheld sleeve; the first connecting ring, the first driving mechanism, the gear switching mechanism, the second driving mechanism and the second connecting ring are sequentially arranged and are coaxial with the handheld sleeve.

Optionally, the first driving mechanism includes a first knob sleeved on the handheld sleeve, the second driving mechanism includes a second knob sleeved on the handheld sleeve, and both the first knob and the second knob are axially kept relatively stationary with respect to the handheld sleeve;

the fixing piece is coaxially arranged with the handheld sleeve and is provided with a first external thread and a second external thread which are axially spaced; the first knob is provided with a first internal thread, and the first external thread is used for matching with the first internal thread; the second knob is provided with a second internal thread, and the second external thread is used for matching with the second internal thread; the thread pitch of the first external thread is M times of that of the second external thread, and M is an integer greater than or equal to 2.

Optionally, a position avoiding structure for avoiding the first external thread and the second external thread is arranged on the handheld sleeve, the position avoiding structure is a hollow limiting groove, and the first external thread penetrates through the limiting groove to be matched with the first internal thread; the second external thread penetrates through the limiting groove to be matched with the second internal thread, and the fixing piece is used for moving axially along the limiting groove.

Optionally, the first knob has a first groove avoiding the first external thread, and the second knob has a second groove avoiding the second external thread;

the driving handle is also provided with an initial mode; when the driving handle is positioned in the initial mode, the first external thread is accommodated in the first groove, and the second external thread is accommodated in the second groove; in the initial mode, the shift position changing mechanism is driven by an external force to restrict the driving handle to the first operation mode or the second operation mode.

Optionally, a plurality of scale marks are axially arranged on the fixing piece, the distance between any two adjacent scale marks is equal to the thread pitch of the first external thread, and meanwhile, an alignment mark is arranged on the handheld sleeve and used for coinciding with any one scale mark so as to limit the driving handle in the initial mode.

Optionally, the alignment mark is an edge line of an end face of the handheld sleeve.

Optionally, the fixing member is a circular rod, and the first external thread and the second external thread are both arranged on the rod along a part of the circumference.

Optionally, the first external thread and the second external thread are both multiple, all the first external threads and all the second external threads are respectively symmetrically arranged on respective circumferences, and all the first external threads and all the second external threads are axially overlapped.

Optionally, the handheld sleeve comprises a handheld section and a connecting section which are axially connected, and the diameter of the connecting section is smaller than that of the handheld section; the first driving mechanism, the second driving mechanism and the gear switching mechanism are all arranged on the connecting section.

Optionally, the driving handle is a manual driving handle.

In order to achieve the above object, the present invention further provides a delivery system for delivering an implant, comprising the driving handle for delivering an implant, and further comprising an outer tube and an inner tube assembly;

the inner tube assembly is arranged in the outer tube in a penetrating mode and used for fixing the implant, is connected with the handheld sleeve of the driving handle and keeps static relative to the handheld sleeve;

the outer tube is connected with the fixing piece of the driving handle, and the fixing piece is used for driving the outer tube to move axially relative to the inner tube assembly.

Optionally, the inner tube assembly penetrates from one end of the fixing piece and penetrates out from the other end of the fixing piece to be connected with the handheld sleeve.

In summary, the driving handle and the delivery system for delivering the implant provided by the invention have the following advantages:

first, the driving handle of the present invention includes a hand-held sleeve, a fixing member, a first driving mechanism, a second driving mechanism, and a shift switching mechanism. In practical use, the operating mode of the driving handle needs to be switched to a first operating mode through the shift switching mechanism, in the first operating mode, the first driving mechanism can move relative to the hand-held sleeve, and meanwhile, the first driving mechanism is matched with the fixing piece, so that the fixing piece can be driven by the first driving mechanism to move at a first speed along the axis of the hand-held sleeve, otherwise, the operating mode of the driving handle is switched to a second operating mode through the shift switching mechanism, in the second operating mode, the second driving mechanism can move relative to the hand-held sleeve, and the second driving mechanism is matched with the fixing piece, so that the fixing piece is driven by the second driving mechanism to move at a second speed along the axis of the hand-held sleeve. In actual operation, the fixing piece is connected with the outer tube of the conveying system, and the driving handle can control the outer tube to move rapidly and slowly, so that different operation requirements can be met in different stages of an operation. In addition, in the operation process, the switching of different working modes of the driving handle is realized by means of the gear switching mechanism, so that a doctor can adjust the driving handle more quickly and accurately according to the current operation requirement, the burden of the doctor in the operation process is reduced, and the operation efficiency is improved.

Secondly, the driving handle is further provided with a gear locking mechanism, and when the driving handle is in the first working mode, the gear locking mechanism is configured to lock the second driving mechanism with the handheld sleeve; and when the drive handle is in the second mode of operation, the range lock mechanism is further configured to lock the first drive mechanism to the hand-held sleeve. Therefore, the interlocking of slow motion and quick motion can be realized through the gear locking mechanism, so that the accuracy of the operation of the driving handle is improved, the operation difficulty of a doctor can be reduced, and the operation efficiency is further improved.

Thirdly, the driving handle is preferably a manual driving handle, and all the structures are coaxially arranged, so that the reliability is high, the radial size is small, the size of the handle is small, the weight is light, and the carrying and the operation are convenient.

Drawings

FIG. 1a is an isometric schematic view of a delivery system in an embodiment of the invention;

FIG. 1b is an isometric cross-sectional view of a delivery system in one embodiment of the invention;

FIG. 1c is an enlarged view of a portion of the delivery system of FIG. 1 b;

FIG. 1d is an exploded view of the drive handle of the delivery system of FIG. 1 a;

FIG. 2 is a schematic view of a hand sleeve on the drive handle in accordance with an embodiment of the present invention;

FIG. 3a is an end view of a diverter switch on the drive handle in one embodiment of the present invention;

FIG. 3b is an isometric cross-sectional view of a diverter switch on the drive handle in one embodiment of the present invention

FIG. 4a is a front view of a first knob on the drive handle in one embodiment of the present invention;

FIG. 4b is an end view of the first knob on the drive handle in one embodiment of the present invention;

FIG. 5a is a front view of a second knob on the drive handle in one embodiment of the present invention;

FIG. 5b is an end view of a second knob on the drive handle in an embodiment of the present invention;

FIG. 6 is a schematic view of a mount on the drive handle according to an embodiment of the present invention;

FIG. 7 is a partial cross-sectional view of a delivery system in an embodiment of the present invention;

FIG. 8 is a schematic view of a valve stent loaded between an inner tube and an outer tube according to an embodiment of the invention.

In the figure:

a driving handle 100;

a hand-held sleeve 1; a hand-held section 11; a connecting section 12; the first connection groove 121; a limiting groove-122; a proximal connecting portion 123;

a first connecting ring 2; a third circumferential projection 21; a first circumferential projection 22;

a first knob 3; the first circumferential groove 31; a first cylindrical section 32; a first limit groove 33; a third cylindrical section 34; a first groove 35; a first internal thread 36; a first stopper surface 37;

a changeover switch 4; a first limit projection 41; a second stopper protrusion 43; a third stopper protrusion 42;

a second knob 5; a second circumferential groove 51; a second cylindrical section 52; a second limit groove 53; a fourth cylindrical section 54; a second groove 55; a second internal thread 56; a second stopper surface 57;

a second connection ring 6; a second circumferential projection 61; a proximal end portion 62;

a fixing member 7; a shaft 71; a first external thread 72; a second external thread 73;

catheter assembly 200;

an outer tube 8;

an inner tube assembly 9; a conical head 91; a fixed head 92; an inner tube 93;

a valve stent 10.

Detailed Description

To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to the appended drawings. It is to be noted that the drawings are in simplified form and are not to scale, but rather are provided for the purpose of facilitating and distinctly claiming the embodiments of the present invention. As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. The terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless otherwise specified.

In the following description, for ease of description, "distal" and "proximal", "axial" and "circumferential" are used; "distal" is the side away from the operator of the delivery system; "proximal" is the side proximal to the operator of the delivery system; "axial" refers to a direction along the axis of the hand sleeve; "circumferential" refers to the axial direction about the corresponding member. Furthermore, in the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. It will be apparent, however, to one skilled in the art, that the present invention may be practiced without one or more of these specific details. In other instances, well-known features have not been described in order to avoid obscuring the invention.

The core idea of the present invention is to provide a driving handle for delivering an implant, which is preferably a manual driving handle, which does not have the problems such as motor abnormality, transmission abnormality, etc., which are easily occurred in the electric driving handle, and thus has high reliability and simple structure.

The driving handle provided by the invention comprises a handheld sleeve, a fixing piece, a first driving mechanism, a second driving mechanism and a gear switching mechanism; at least one part of the fixing piece is movably arranged in the handheld sleeve in a penetrating way; the first driving mechanism, the second driving mechanism and the gear switching mechanism are all arranged on the handheld sleeve;

wherein: the drive handle has a first operating mode and a second operating mode, and the range switching mechanism is configured to define the drive handle in one of the first operating mode and the second operating mode;

when the drive handle is in the first working mode, the first driving mechanism is configured to be matched with the fixed piece so as to drive the fixed piece to move along the axis of the handheld sleeve at a first speed; when the drive handle is in the second working mode, the second drive mechanism is configured to cooperate with the fixed member to drive the fixed member to move along the axis of the hand-held sleeve at a second speed, the second speed being less than the first speed.

The working principle of the driving handle is as follows:

a) and (3) rapid movement: the operating mode of the driving handle needs to be switched to a first operating mode (namely a quick operating mode) through the gear switching mechanism, in the mode, the first driving mechanism can move relative to the handheld sleeve, and meanwhile, the first driving mechanism is matched with the fixing piece, so that the fixing piece can be driven by the first driving mechanism to move quickly along the axis of the handheld sleeve;

b) slow motion: the operating mode of the driving handle is switched to a second operating mode (namely, a slow operating mode) through the gear switching mechanism, in the mode, the second driving mechanism can move relative to the handheld sleeve, and the second driving mechanism is matched with the fixing piece, so that the fixing piece is driven by the second driving mechanism to move slowly along the axis of the handheld sleeve.

Obviously, in the operation process, the switching of different working modes of the driving handle is realized by means of the gear switching mechanism, so that the driving handle can be adjusted more quickly and accurately by a doctor according to the current operation requirement, the burden of the doctor in the operation process is reduced, and the operation efficiency is improved.

Furthermore, the driving handle further comprises a gear locking mechanism arranged on the handheld sleeve. The range lock mechanism is configured to lock the second drive mechanism to the hand-held sleeve when the drive handle is in the first operating mode; and when the drive handle is in the second operating mode, the range lock mechanism is further configured to lock the first drive mechanism to the hand-held sleeve. Therefore, the interlocking of slow motion and quick motion can be realized through the gear locking mechanism, so that the operation accuracy of the driving handle is improved, the operation difficulty of a doctor can be reduced, and the operation efficiency is further improved. Specifically, when the drive handle is in the first mode of operation, the second drive mechanism is maintained in a locking relationship with the hand-held socket via the range locking mechanism, such that the second drive mechanism remains stationary (neither movable nor rotatable) relative to the hand-held socket; conversely, when the drive handle is in the second mode of operation, the first drive mechanism is held in locking relation with the hand sleeve by the range lock mechanism, thereby holding the first drive mechanism stationary relative to the hand sleeve. Therefore, by means of interlocking of slow motion and fast motion, manual misoperation can be effectively avoided, operation difficulty of doctors is reduced, and accuracy of operation is improved.

Further, when the drive handle is in the first operating mode, the shift position switching mechanism is further configured to lock the second drive mechanism with the hand-held sleeve; the shift position switching mechanism is further configured to lock the first drive mechanism to the hand-held sleeve when the drive handle is in the second operating mode. Therefore, the locking and switching of the gears can be realized through one structure, the operation is more convenient, and the structure of the driving handle is simpler.

Further, the shift position changing mechanism is movably disposed on the grip sleeve. Specifically, the shift position changing mechanism has a first position and a second position; when the shift position changing mechanism is moved to the first position, the drive handle is restricted to the first operating mode while the shift position changing mechanism also locks the second drive mechanism with the grip sleeve; when the shift position changing mechanism is moved to the second position, the drive handle is further limited to the second operating mode, while the shift position changing mechanism also locks the first drive mechanism to the hand sleeve. During the in-service use, as long as manual drive gear switching mechanism moves to above-mentioned position, alright convenient, switch to corresponding working mode fast, when gear switching mechanism moved to these positions moreover, through the structure of self alright with the locking of the drive mechanism who corresponds mutually with handheld sleeve, the structure is simpler like this, it is more convenient to operate.

The preferred construction and operation of the drive handle and delivery system incorporating the drive handle is further described below with reference to the accompanying drawings.

Referring first to fig. 1a and 1b, fig. 1a is an isometric view of a delivery system in an embodiment of the invention, and fig. 1b is an isometric cross-sectional view of the delivery system in an embodiment of the invention. As shown in fig. 1a and 1b, a delivery system for delivering an implant includes an actuating handle 100 and a catheter assembly 200. The catheter assembly 200 includes an outer tube 8 and an inner tube assembly 9; the inner pipe assembly 9 is arranged in the outer pipe 8 in a penetrating way and is coaxial with the outer pipe 8; the outer tube 8 is adapted to be connected to a driving handle 100, so that the driving handle 100 drives the outer tube 8 to move relative to the inner tube assembly 9. preferably, the outer tube 8 only moves axially and not circumferentially, so as to ensure the positioning accuracy of the implant when released in vivo.

The driving handle 100 includes a hand-held sleeve 1, a first knob 3, a changeover switch 4, a second knob 5, and a fixing member 7. First knob 3, change over switch 4 and second knob 5 all set up on handheld sleeve 1, and mounting 7 movably wears to establish in handheld sleeve 1 to be used for passing through screw-thread fit with first knob 3 and second knob 5, thereby be quick motion by first knob 3 drive mounting 7, and be slow motion by second knob 5 drive mounting 7. It should be understood that: the first knob 3 constitutes a first driving mechanism of the present invention; the second knob 5 constitutes a second driving mechanism of the present invention; the change-over switch 4 constitutes the gearshift mechanism of the present invention, and preferably the change-over switch 4 also constitutes the gearshift mechanism of the present invention.

In the present embodiment, the second knob 5, the changeover switch 4 and the first knob 3 are arranged in this order from the proximal end to the distal end of the drive handle, but in other embodiments, the first knob 3, the changeover switch 4 and the second knob 5 may be arranged in this order from the proximal end to the distal end. In the following description, for ease of description, the preferred construction of drive handle 100 is further described in the arrangement shown in FIG. 1 a.

As shown in fig. 1a and 1b, the first and

second knobs

3 and 5 are rotatably mounted on the hand sleeve 1 and preferably coaxially with the hand sleeve 1, and both knobs are axially stationary relative to the hand sleeve 1, i.e. can only be rotated but not moved axially. In addition, the switch 4 is arranged between the first knob 3 and the second knob 5 and can move back and forth between the two knobs, in the embodiment of the invention, the switch 4 is constructed in a sleeve structure and is directly sleeved on the handheld sleeve 1 or sleeved on the two knobs, the switch 4 can only move but cannot rotate circumferentially, and the switch 4 is preferably coaxial with the handheld sleeve 1. Of course, the switch 4 is not limited to the sleeve form, and may also be a slider structure, and the structure of the switch 4 is not particularly limited in the present invention.

The fixing piece 7 can be partially arranged in the handheld sleeve 1 in a penetrating mode, can also be wholly arranged in the handheld sleeve 1, and can reduce the length of the driving handle if the fixing piece is arranged in a whole mode, so that the size and the weight of the driving handle are reduced. The fixing member 7 may be a circular rod member, such as a screw rod, etc., as shown in fig. 6; alternatively, the fixing member 7 may also be a strip-shaped member, such as a rack; the specific structure of the fixing member 7 is not particularly limited in the present invention, as long as it can cooperate with the two knobs to drive the outer tube 8 to move axially. Taking the example shown in fig. 6, the fixing member 7 is configured as a circular rod member, which is preferably arranged coaxially with the hand-held sleeve 1, and the shaft 71 of the rod member is provided with two kinds of threads, namely a first external thread 72 and a second external thread 73, the first external thread 72 and the second external thread 73 are axially spaced apart, and the pitch P1 of the first external thread 72 is greater than the pitch P2 of the second external thread 73. Also shown in fig. 4b, the first knob 3 has a first inner bore with a first inner thread 36, the first inner thread 36 for mating with the first outer thread 72; as shown in fig. 5b, the second knob 5 has a second inner bore with a second inner thread 56, the second inner thread 56 for mating with a second outer thread 73.

When the driving handle 100 needs to work in a fast working mode, the driving handle 100 is firstly locked in the fast working mode by the switch 4, at this time, the fixing piece 7 is matched with the first internal thread 36 on the first knob 3 through the first external thread 72, and then the fixing piece 7 can be driven to move fast along the axis of the handheld sleeve 1 as long as the first knob 3 is rotated;

on the contrary, when the driving handle 100 needs to work in the slow-speed working mode, the driving handle 100 is also locked in the slow-speed working mode through the switch 4, and the fixing member 7 is matched with the second internal thread 56 on the second knob 5 through the second external thread 73, so that the fixing member 7 can be driven to move slowly along the axis of the handheld sleeve 1 by only rotating the second knob 5.

In the present embodiment, the fixing element 7 is preferably held stationary relative to the hand sleeve 1 in the circumferential direction, i.e. the fixing element 7 is only axially displaceable and not circumferentially rotatable, so that the outer tube 8 is driven in an axial movement relative to the inner tube assembly 9. Obviously, the screw thread pitch of first knob 3 is great, can realize rapid movement to improve operation efficiency, and the screw thread pitch of second knob 5 is less, can realize slow motion, thereby can realize more accurate positioning control, makes the operator more easy accurate operation, reduces the operation degree of difficulty.

Besides, the switch 4 can realize the switching of the working mode, and can also realize the interlocking of slow movement and fast movement. As shown in fig. 1a, the switch 4 can be manually shifted to a first position (i.e. the position shown in b), i.e. the driving handle 100 can be limited to the fast operating mode, and when the switch 4 is located at the first position, it can also directly lock the second knob 5 with the hand-held sleeve 1; on the contrary, if the switch 4 is manually shifted to the second position (i.e. the position shown by a), the driving handle 100 can be switched to the slow-speed working mode, and at this time, the switch 4 can also directly lock the first knob 3 and the handheld sleeve 1. For example, when the switch 4 is moved to the first position in the direction of the second knob 5, the switch 4 can cooperate with the second knob 5 to lock the second knob 5, so as to prevent the second knob 5 from rotating; when the switch 4 moves to the second position toward the first knob 3, the switch 4 can be matched with the first knob 3 to lock the first knob 3, so as to prevent the first knob 3 from rotating; the operation is very convenient, and the structure is simple.

Optionally, a first limiting portion is disposed on one side of the first knob 3 facing the second knob 5, and a third limiting portion is disposed on the switch 4, and when the switch 4 is located at the second position, the third limiting portion is matched with the first limiting portion to limit the rotation of the first knob 3 in the circumferential direction of the handheld sleeve 1. As shown in fig. 3a to 3b, and with reference to fig. 1c to 1d and 4, the first limiting portion can be selected as a first limiting groove 33 extending axially on the first knob 3, and the third limiting portion is a first limiting protrusion 41 extending axially on the switch 4, and the first limiting protrusion 41 is inserted into the first limiting groove 33, so that the first knob 3 and the handheld sleeve 1 can be conveniently and quickly locked. And when the switch 4 is located at the first position, the first limiting protrusion 41 needs to be able to completely disengage from the first limiting groove 33, so as to ensure that the first knob 3 can smoothly rotate during fast movement.

Optionally, one side of the second knob 5 facing the first knob 3 is provided with a second limiting portion, and the change-over switch 4 is further provided with a fourth limiting portion, and when the change-over switch 4 is located at the first position, the fourth limiting portion is matched with the second limiting portion to limit the movement of the second knob 5 in the circumferential direction of the handheld sleeve 1. As shown in fig. 3a to fig. 3b and fig. 5, and with reference to fig. 1c and fig. 1d, the second limiting portion may be selected as a second limiting groove 53 extending axially on the second knob 5, and the fourth limiting portion is a second limiting protrusion 43 extending axially on the switch 4, so that the second knob 5 can be conveniently and quickly locked with the handheld sleeve 1 by inserting the second limiting protrusion 43 into the second limiting groove 53. Similarly, when the switch 4 is located at the second position, the second limiting protrusion 43 also needs to be able to completely disengage from the second limiting groove 53, so as to ensure that the second knob 5 can smoothly rotate during slow movement.

It should also be appreciated that, in actual use, when the first limiting groove 33 and the second limiting groove 53 are aligned in the axial direction, the switch 4 can be toggled to switch between the fast operating mode and the slow operating mode. And for any knob, the number of the limiting grooves is not limited to one, and can be multiple, the multiple limiting grooves are arranged around the axis of the handheld sleeve 1 at intervals, and of course, when the working mode is switched, all the limiting grooves on the two knobs need to be aligned one by one. Correspondingly, when the limiting grooves on each knob are multiple, the limiting protrusions on the change-over switch 4 are also multiple, and the limiting protrusions and the limiting grooves are matched one by one to realize matched locking.

As described above, since the selector switch 4 is not rotatable with respect to the grip sleeve 1, it can restrict the rotation of the corresponding knob in both the first position and the second position. For this purpose, a fifth limiting portion is preferably disposed on the switch 4, and a sixth limiting portion is disposed on the hand-held sleeve 1, and the sixth limiting portion is configured to cooperate with the fifth limiting portion to limit the movement of the switch 4 in the circumferential direction of the hand-held sleeve 1. As shown in fig. 3a, the changeover switch 4 has a third inner hole having a third stopper protrusion 42 serving as a fifth stopper, the third stopper protrusion 42 extending radially inward of the third inner hole. Meanwhile, as shown in fig. 2, a radial hollow-out limiting groove 122 is arranged on the handheld sleeve 1. The third limit projection 42 is inserted into the limit groove 122, thereby limiting the circumferential rotation of the switch 4. Preferably, the third limiting protrusions 42 are a plurality of and are preferably symmetrically distributed, and more preferably, the number of the third limiting protrusions 42 is two, so that the anti-rotation effect is good, and the structure is simple. Of course, the width of the limiting groove 122 is larger than that of the third limiting protrusion 42, so that the switch 4 can move back and forth along the limiting groove 122.

Further, in order to ensure that the external thread on the fixing member 7 can be matched with the internal thread on the knob, a avoiding structure for avoiding the external thread is further arranged on the handheld sleeve 1. Preferably, the limiting groove 122 constitutes the avoiding structure, so that all external threads on the fixing member 7 can pass through the limiting groove 122 to match with the internal threads on the knob, and the limiting groove 122 is further used for limiting the fixing member 7 to move only axially along the groove. As shown in fig. 2, the limiting groove 122 is opened from the distal end to the proximal end of the handheld sleeve 1, but the length is smaller than that of the handheld sleeve 1, and the limiting groove 122 is hollowed out in the radial direction, that is, one side of the handheld sleeve 1 can see the opposite side through the limiting groove 122. The cross section of the limiting groove 122 may be rectangular, kidney-shaped, oval, etc., and the present invention is not particularly limited thereto. The opening manner of the limit groove 122 is not specifically limited in the present invention, and one limit groove 122 as shown in fig. 2 may be formed at one time, or a plurality of limit grooves 122 may be axially formed in segments, for example, one limit groove 122 is separately formed for each of the second external thread 73, the first external thread 42, and the switch 4. In a word, as long as ensure that the external screw thread on mounting 7 can pass corresponding spacing slot and knob cooperation can, also need to ensure simultaneously that change over switch 4 can remove and normally switch in the spacing slot that corresponds can, in addition, the effective stroke that the mounting will remove when quick motion and slow motion also need to be ensured to the length of spacing slot.

As shown in fig. 6, the first external thread 72 and the second external thread 73 are both provided on the shaft 71 along a part of the circumference, i.e., neither the first external thread 72 nor the second external thread 73 is a full circumference thread. Wherein the second external thread 73 is not limited to being provided on the proximal end of the shaft 71, but is shown as being provided to facilitate reducing the length of the shaft and thus the handle.

In the embodiment of the present invention, a plurality of first external threads 72 may be disposed on the shaft 71, and all the first external threads 72 are distributed at intervals along the same circumference, but the number of the first external threads 72 is required to be corresponding to the number of the limiting grooves 122, for example, one radially hollow limiting groove 122 may simultaneously receive two symmetrical first external threads 72, and then, N limiting grooves 122 may receive 2N first external threads 72, where N is an integer greater than or equal to 1. Preferably, all of the first external threads 72 are symmetrical about the axis of the shaft 71, i.e., are symmetrically disposed on the shaft 71. Similarly, a plurality of second external threads 73 can be disposed on the shaft 71, all the second external threads 73 are also spaced along the same circumference, and the number of the second external threads 73 is required to correspond to the number of the limiting grooves 122. Preferably, all of the second external threads 73 are also symmetrical about the axis of the shaft 71. However, if the fixing member 71 is a rack, the two opposite surfaces of the rack body may be provided with external threads, and at this time, only one limiting groove 122 may be provided. According to the invention, the plurality of first external threads 72 or the plurality of second external threads 72 are arranged, so that the transmission is more stable, and the transmission precision is higher. In addition, the total pitch of each first external thread 72 in the axial direction needs to be larger than the effective stroke for the rapid movement, while the total pitch of each second external thread 73 in the axial direction needs to be larger than the effective stroke for the slow movement. Further, the first male screw 72 and the second male screw 73 may or may not overlap (i.e., may be circumferentially offset) as viewed in the axial direction, and preferably overlap each other to simplify the structure and the operation. Here, "axially coincide" means that orthogonal projections of the first external thread 72 and the second external thread 73 in the same plane in the axial direction coincide. Orthographic coincidence is not to be construed narrowly as meaning that the first external thread 72 and the second external thread 73 are identical in shape and size, but rather should be construed broadly as meaning that the positions of the two overlap, for example, the midpoint of the first external thread 72 in the circumferential direction coincides with the midpoint of the second external thread 73 in the circumferential direction, this coincidence being independent of the shape and size of the threads.

In actual use, in order to ensure that the changeover switch 4 can be normally switched, the following conditions are preferably satisfied:

a) conversion of fast motion to slow motion: the first limiting groove 33 on the first knob 3 is aligned with the second limiting groove 53 on the second knob 5, so that after the second limiting protrusion 43 is separated from the second limiting groove 53, the first limiting protrusion 41 can be smoothly inserted into the first limiting groove 33, and meanwhile, the first knob 3 and the second knob 5 are disengaged from the fixing piece 7;

b) slow motion to fast motion conversion: the first limiting groove 33 on the first knob 3 is aligned with the second limiting groove 53 on the second knob 5, so that after the first limiting protrusion 41 is separated from the first limiting groove 33, the second limiting protrusion 43 can be smoothly inserted into the second limiting groove 53, and meanwhile, the first knob 3 and the second knob 5 are disengaged from the fixing piece 7.

As shown in fig. 4b, the first knob 3 further has a first groove 35, the first groove 35 is disposed in the first inner bore of the first knob 3 and extends axially, and it is apparent that the first groove 35 divides the first inner thread 36 into several parts in the circumferential direction. Therefore, when the fast movement is switched to the slow movement, if the first external thread 72 just enters the first groove 35, the matching relationship between the first external thread 72 and the first internal thread 36 can be released, so that the first knob 3 can just avoid the first external thread 72 on the fixing member 7 during the slow movement. Obviously, the number of said first recesses 35 should correspond to the number of first external threads 72. Of course, the distribution of the first external thread 72 also determines the distribution of the first recesses 35.

Similarly, as shown in fig. 5b, the second knob 5 further has a second groove 55, the second groove 55 is disposed in the second inner bore of the second knob 5 and extends axially, and it is apparent that the second groove 55 divides the second internal thread 56 into several parts in the circumferential direction. Therefore, when the slow movement is switched to the fast movement, if the second external thread 73 just enters the second groove 55, the matching relationship between the second external thread 73 and the second internal thread 56 can be released, so that the second knob 5 just avoids the second external thread 73 on the fixing member 7 during the fast movement. Also, the number of the second grooves 55 corresponds to the number of the second external threads 73. It will be appreciated that the first and

second recesses

35, 55 are also true based on the first and second

external threads

72, 73 being axially coincident or non-coincident. Therefore, when the operation mode is switched, if the second external thread 73 enters the second recess 55 and the first external thread 72 also enters the first recess 35, the switch 4 can be operated.

Further, the drive handle 100 further comprises a first and a second connector, each configured to remain at least axially stationary relative to the hand sleeve 1, i.e. not axially movable. Wherein the first connecting piece is used for limiting the movement of the first knob 3 in the axial direction of the hand sleeve 1, and the second connecting piece is used for limiting the movement of the second knob 5 in the axial direction of the hand sleeve 1. However, in other embodiments, it is also possible that the hand sleeve 1 itself is provided with corresponding structures to limit the axial freedom of the two knobs. The present invention is not particularly limited in this regard. Here, the arrangement of the first connecting piece and the second connecting piece is convenient for simplify the structure of the handheld sleeve 1 and reduce the processing difficulty.

Further, as shown in fig. 1a to fig. 1b and fig. 1d, the first connecting member includes a first connecting ring 2 disposed on the handheld sleeve 1, and the second connecting member includes a second connecting ring 6 disposed on the handheld sleeve 1. In one embodiment, the first connection ring 2, the first knob 3, the switch 4, the second knob 5 and the second connection ring 6 are arranged in sequence from the distal end to the proximal end, and preferably these members are all arranged coaxially with the hand-held sleeve 1, and in other embodiments, the second connection ring 6, the second knob 5, the switch 4, the first knob 3 and the first connection ring 2 are arranged in sequence from the distal end to the proximal end.

As shown in fig. 1c and 4a, the first connection ring 2 has a first circumferential protrusion 22 (i.e., a first connection structure), and the first knob 3 has a first circumferential groove 31 (i.e., a third connection structure), and the first circumferential protrusion 22 is inserted into the first circumferential groove 32, so that the first knob 3 is limited from moving in the axial direction of the grip sleeve 1, but the first knob 3 can still rotate in the circumferential direction.

As shown in fig. 1c and 5a, the second connection ring 6 has a second circumferential protrusion 61 (i.e., a second connection structure), and the second knob 5 has a second circumferential groove 51 (i.e., a fourth connection structure), and the second circumferential protrusion 61 is inserted into the second circumferential groove 51 to limit the axial movement of the second knob 5 in the axial direction of the handle sleeve 1, but the second knob 5 can still rotate in the circumferential direction. Of course, in other embodiments, the first circumferential projection 22 on the primary connecting ring 2 may be replaced by a circumferential groove, and the first circumferential groove 31 on the primary knob 3 may be replaced by a circumferential projection. Likewise, the second circumferential projection 61 on the second connection ring 6 may be replaced by a circumferential groove, while the second circumferential groove 51 on the second knob 5 may be replaced by a circumferential projection. Thus, one of the first and third connecting structures is a circumferential projection and the other is a circumferential groove; similarly, one of the second connecting structure and the fourth connecting structure is a circumferential protrusion, and the other is a circumferential groove.

In the embodiment of the present invention, the first connection ring 2 and the second connection ring 6 are both kept axially relatively stationary with respect to the handheld sleeve 1, and the first connection ring 2 and the second connection ring 6 are also preferably kept circumferentially relatively stationary with respect to the handheld sleeve 1, but the present invention is not particularly limited to the manner of achieving circumferential fixation, and may be an interference fit connection, a key way connection, a screw connection, a glue bonding, or the like.

With continued reference to fig. 1c and 2, the first connection ring 2 further has a third circumferential protrusion 21, the third circumferential protrusion 21 is inserted into the first connection groove 121 of the hand-held sleeve 1, wherein the third circumferential protrusion 21 and the first connection groove 121 can be fixed by interference fit, glue bonding, etc. The second connecting ring 6 further has a proximal portion 62, and the proximal portion 62 is disposed on the proximal connecting portion 123 of the hand-held sleeve 1 and can be glued to the proximal connecting portion 123.

Further, as shown in fig. 1b and fig. 2, the hand-held sleeve 1 specifically includes a hand-held section 11 and a connecting section 12, the hand-held section 11 is located at the distal end of the driving handle 100, so that the operator can hold the hand-held section 11 to operate the handle. For convenience of operation, the surface of the hand-holding section 11 may be made of a frosted material or provided with ribs, waves, etc. to increase friction force and optimize operation feeling, and the present invention is not particularly limited thereto. The connecting section 12 is located at the proximal end of the driving handle 100, and the outer diameter of the connecting section 12 is smaller than that of the holding section 11, wherein the first connecting ring 2, the first knob 3, the switch 4, the second knob 5 and the second connecting ring 6 are all arranged on the connecting section 12. The retaining groove 122 extends from the hand-held section 11 to the connecting section 12.

Further, as shown in fig. 4a, the first knob 3 may include a first cylindrical section 32 in the middle and third cylindrical sections 34 at both sides, and the outer diameter of the third cylindrical section 34 is smaller than that of the first cylindrical section 32. The first cylindrical section 32 is used for manual rapid circumferential adjustment, the third cylindrical section 34 on the left side is used for being connected with the first connecting ring 2, and the third cylindrical section 34 on the right side is used for sleeving the selector switch 4. Therefore, the first circumferential groove 31 is formed on the third cylindrical section 34 on the left side in a circle, and the first limiting surface 37 is formed on the third cylindrical section 34 and the first cylindrical section 32 on the right side, so that the moving distance of the switch 4 can be limited, i.e. when the switch 4 abuts against the first limiting surface 37, i.e. the second position is limited. The first position-limiting groove 33 is formed on the first cylindrical section 32, and extends axially from the proximal end to the distal end of the first cylindrical section 32, and the first position-limiting groove 33 is preferably not communicated with the inner hole of the first knob 3, so as to prevent foreign matters from entering the handle. In addition, the third cylindrical section 34 on the right side preferably always engages with the switch 4, in order to prevent foreign bodies from entering the inside of the handle. Therefore, the distance when the switch 4 is moved from the second position to the first position should be less than the length of the right third cylindrical section 34.

As shown in fig. 5a, the second knob 5 may also include a middle second cylindrical section 52 and fourth cylindrical sections 54 at both sides, wherein the outer diameter of the fourth cylindrical section 54 is smaller than the outer diameter of the second cylindrical section 52. The second cylindrical section 52 is used for manual slow circumferential adjustment, the fourth cylindrical section 54 on the right side is used for connecting with the second connection ring 6, and the fourth cylindrical section 54 on the left side is used for sleeving the selector switch 4. Therefore, the fourth cylindrical section 54 on the right is formed with a second circumferential groove 51 circumferentially, and the fourth cylindrical section 54 on the right and the second cylindrical section 52 are formed with a second limiting surface 57, which can limit the moving distance of the switch 4, i.e. when the switch 4 abuts against the second limiting surface 57, i.e. at the first position. The second limiting groove 53 is specifically formed on the second cylindrical section 52, and extends from the distal end surface of the second cylindrical section 52 to the proximal end, and the second limiting groove 53 is preferably not communicated with the inside of the second knob 5, so that foreign objects can be prevented from entering the handle. In addition, the second cylindrical section 54 preferably always engages with the diverter switch 4, thereby preventing foreign objects from entering the interior of the handle. Therefore, when the switch 4 is moved from the first position to the second position, the distance is less than the length of the second cylindrical section 54.

Further, the pitch P1 of the first external thread 72 and the pitch P2 of the second external thread 73 preferably have the following relationship: P1-M × P2, M being an integer greater than or equal to 2. Wherein, the appropriate value of M can be selected according to the requirement of the operation on the difference of multiple of the fast speed and the slow speed, that is, the displacement generated by one turn of the first knob 3 is the displacement generated by M turns of the second knob 3.

Furthermore, the fixing element 7, for example, a plurality of graduation lines are axially arranged on the shaft 71 at intervals, and the distance between adjacent graduation lines is equal to the pitch P1 of the first external thread 72, that is, the fixing element 7 can move by one graduation when the first knob 3 rotates by one circle, so that an operator can determine the conveying stroke according to the graduation lines, and the operation is more accurate and convenient. More preferably, the hand sleeve 1 is provided with an alignment mark for coinciding with any of the graduation marks to define the drive handle in the initial mode. When the driving handle is in the initial mode, the switch 4 can be operated, that is, when any one of the scale marks is coincident with the alignment mark on the hand-held sleeve 1, the driving handle is in the initial mode: the grooves on the two knobs are just avoided from opening the external threads on the fixing piece, and meanwhile, the limiting grooves on the two knobs are also axially aligned.

Optionally, the alignment mark is an edge line of the distal end face of the hand-held segment 11.

Therefore, in the embodiment of the present invention, the conditions under which the switch 4 can normally switch include:

first, P1 ═ M × P2;

the distance between any two adjacent graduation marks is P1;

thirdly, any scale mark can be ensured to be coincident with the alignment mark.

In more detail, when any scale mark on the fixing member 7 just coincides with the edge line on the handheld section 11, the first limit groove 33 on the first knob 3 just aligns with the second limit groove 53 on the second knob 5, and the grooves on the two knobs respectively avoid the external threads on the fixing member 7, at this time, the slow motion can be switched, as long as the change-over switch 4 is toggled towards the first knob 3, that is, the change-over switch 4 is separated from the second knob 5 and is matched with the first knob 3, so that the change-over switch 4 limits the circumferential motion of the first knob 3, at this time, the second knob 5 can be rotated, and the fixing member 7 is driven by the second knob 5 to perform the slow axial motion. And then when any scale mark on the fixed part 7 just coincides with the edge line on the handheld section 11, the second limit groove 53 on the second knob 5 can be ensured to be just aligned with the second limit groove 33 on the first knob 3, and meanwhile, the grooves on the two knobs are respectively avoided from the external thread on the fixed part 7, at the moment, the fast movement can be converted, as long as the change-over switch 4 is shifted to the second knob 5 side, namely, the change-over switch 4 is separated from the first knob 3 and is matched with the second knob 5. Similarly, after the fast movement is switched, when any scale mark on the fixing part 7 is just overlapped with the edge line on the handheld section 11, the slow movement can be switched.

Further, as shown in fig. 8, the inner tube assembly 9 specifically includes, from the proximal end to the distal end, an inner tube 93, a fixed head 92 and a tapered head 91 connected in series. Taking an implant as an example of the valve stent 10, fig. 8 shows the valve stent 10 in an unreleased state, as can be clearly understood from fig. 8, when the valve stent 10 is delivered, the valve stent 10 is loaded on the periphery of the inner tube 93 between the tapered head 91 and the fixed head 92, and is fixedly supported by the fixed head 92 (one end of the valve stent 10 is fixed on the fixed head 92), while the fixed head 92 is not movable (i.e. all degrees of freedom are limited), and the proximal end of the inner tube 93 is fixedly connected with the handheld sleeve 1 by threads or glue, so that the inner tube 93 is integrally fixed relative to the handheld sleeve 1, thereby ensuring that the valve stent 10 loaded on the fixed head 92 and the handheld sleeve 1 are kept relatively fixed. The distal end of the outer tube 8 fits over the periphery of the valve stent 10 loaded on the inner tube 93, and preferably the distal end of the outer tube 8 contacts the proximal end face of the tapered head 91 at the distal end of the inner tube 93.

In practice, the outer tube 8 may be connected to the distal end of the fixation member 7, as shown in fig. 1b, and is preferably arranged coaxially with the fixation member 7. In addition, the inner tube assembly 9 can be connected with the proximal end of the handheld sleeve 1 after sequentially passing through the outer tube 8 and the fixing member 7, wherein the proximal end of the inner tube assembly 9 can extend out of the handheld sleeve 1 or can not extend out of the handheld sleeve 1. Then, the fixing member 7 can drive the outer tube 8 to move back and forth in a manual driving mode, so that the outer tube 8 moves back and forth relative to the inner tube assembly 9, and loading, releasing, recovering and the like of the valve stent 10 can be achieved.

More specifically, the loading process of the valve stent 10 is:

first, the drive handle 100 is set in the initial mode: that is, any graduation mark on the fixing member 7 is exactly overlapped with the edge line on the hand-held sleeve 1, and preferably, the conical head 91 is contacted with the distal end part of the outer tube 8;

thereafter loading the valve stent 10: the handheld section 11 can be held by the left hand, the change-over switch 4 is shifted to the second knob 5, the first knob 3 is rotated anticlockwise by the right hand, the fixing piece 7 is driven by the rotation of the first knob 3 to withdraw the outer tube 8 to the near end quickly, so that the fixing head 92 is exposed, any scale mark is overlapped with the edge line on the handheld section 11, and the valve stent 10 is loaded on the tube section of the inner tube 93 between the fixing head 92 and the conical head 91;

then, the switch 4 is toggled to the first knob 3, and then the second knob 5 is rotated clockwise, so that the fixing member 7 drives the outer tube 8 to advance towards the distal end at a slow speed by the rotation of the second knob 5, thereby the distal end of the outer tube 8 is sleeved on the periphery of the valve stent 10 loaded on the inner tube 93.

After the valve stent 10 is loaded, the valve stent 10 can be further implanted into the body through the catheter assembly 200, and during the process of implanting the valve stent 10, the following operation requirements are included:

first, to slowly release the stent prior to positioning, the outer tube 8 needs to be withdrawn at a slower rate, at which time the drive handle 100 can be operated: firstly, the driving handle 100 is also set in an initial mode, namely any scale mark on the fixing piece 7 is just overlapped with an edge line on the handheld section 11, then the change-over switch 4 is shifted to the first knob 3, and then the second knob 5 is rotated anticlockwise, so that the fixing piece 7 drives the outer tube 8 to be slowly withdrawn; it should be understood that a slow release rate is beneficial to improving the accuracy of the release position;

secondly, after positioning, in order to improve the efficiency of release and save the operation time, the following operations are needed: setting the driving handle 100 in an initial mode, then, shifting the change-over switch 4 to the second knob 5, and then, rotating the first knob 3 counterclockwise, so that the fixing member 7 drives the outer tube 8 to be quickly retracted; however, in the final stage of the release of the valve stent, in order to check the position of the valve stent and also to avoid the transient impact effect caused by too fast release speed, the valve stent needs to be released slowly again,

in the process of recovering the valve stent 10, the change-over switch 4 can be shifted to the second knob 5, and then the first knob 3 is rotated clockwise, so that the fixing member 7 drives the outer tube 8 to advance rapidly towards the far end, and the rapid recovery of the valve stent 10 can be realized.

Therefore, in different stages of the operation, different operation requirements can be conveniently met by adjusting the advancing speed of the driving handle 100 according to the operation requirements, so that the operation efficiency is improved, the operation difficulty is reduced, the positioning precision of the valve stent is improved, and a better treatment effect is achieved.

The above embodiment mainly illustrates the preferred structure of the driving handle when the second knob 5, the switch 4 and the first knob 3 are arranged in sequence from the proximal end to the distal end, but it should be understood that the positions of the second knob 5 and the first knob 3 can be interchanged, and after the interchange, the structure and operation of the driving handle are basically the same as those of the previous embodiment, and the detailed content is not further described here, and those skilled in the art should be able to know the specific structural adjustment based on the disclosure of the present application, so as to modify the driving handle. It will be appreciated that the pitch of the large thread is M times the pitch of the small thread, and the distance between any adjacent graduations on the fixing 7 is the pitch of the large thread, while when the actuating handle is in the initial mode, it is also necessary to satisfy: when an arbitrary scale mark coincides with the edge line of the upper far end of the handheld sleeve, the change-over switch can be smoothly matched with the corresponding knob, and the two knobs are all in thread fit relation with the fixing piece, so that the change-over switch 4 can be switched between slow motion and fast motion under the condition that the conditions are met.

Finally, the preferred embodiments of the present invention are described above, but not limited to the scope of the disclosure of the above embodiments, for example, the present invention is not limited to the structure of the first driving mechanism and the second driving mechanism, as long as the two driving mechanisms can achieve fast and slow movement of the fixing member. In addition, the embodiments of the present invention are described with reference to a valve stent 10 (e.g., a heart valve stent) as an implant. It will be appreciated by those skilled in the art that the delivery system disclosed herein may be used to place other implants (e.g., vascular stents) into corresponding locations in the body in addition to valve stents. In addition, the parts in the driving handle are coaxially assembled, and the radial size is small, so that the handle is small in size, light in weight and convenient to carry and operate.

The embodiments in the present description are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same and similar parts among the embodiments are referred to each other.

The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the appended claims.

Claims

1. A driving handle for conveying an implant is characterized by comprising a handheld sleeve, a fixing piece, a first driving mechanism, a second driving mechanism and a gear switching mechanism; at least one part of the fixing piece is movably arranged in the handheld sleeve in a penetrating mode, and the first driving mechanism, the second driving mechanism and the gear switching mechanism are all arranged on the handheld sleeve;

the drive handle has a first operating mode and a second operating mode, and the shift-position switching mechanism is configured to define the drive handle as being in one of the first operating mode and the second operating mode; when the drive handle is in the first working mode, the first driving mechanism is configured to be matched with the fixed piece so as to drive the fixed piece to move along the axis of the handheld sleeve at a first speed; when the drive handle is in the second mode of operation, the second drive mechanism is configured to cooperate with the fastener to drive the fastener to move along the axis of the hand-held sleeve at a second speed, the second speed being less than the first speed.

2. The drive handle for delivering an implant of claim 1, further comprising a shift lock mechanism disposed on the hand-held sleeve;

the range lock mechanism is configured to lock the second drive mechanism to the hand-held sleeve when the drive handle is in the first operating mode; the range lock mechanism is configured to lock the first drive mechanism to the hand-held sleeve when the drive handle is in the second mode of operation.

3. The drive handle for delivering an implant of claim 1, wherein the shift mechanism is further configured to lock the second drive mechanism with the hand-held sleeve when the drive handle is in the first mode of operation; the shift position switching mechanism is further configured to lock the first drive mechanism to the hand-held sleeve when the drive handle is in the second operating mode.

4. The drive handle for delivering an implant of claim 3, wherein the shift position switching mechanism is movably disposed on the hand-held sleeve;

the shift-position switching mechanism has a first position and a second position; when the shift position changing mechanism is moved to the first position, the drive handle is limited to the first operating mode, and the shift position changing mechanism also locks the second drive mechanism with the hand sleeve;

the drive handle is further constrained to the second operating mode when the shift-position mechanism is moved to the second position, and the shift-position mechanism further locks the first drive mechanism to the hand-held sleeve.

5. The drive handle for delivering an implant of claim 4, wherein the shift mechanism comprises a switch movably disposed on the hand-held sleeve between the first and second drive mechanisms, the switch being circumferentially stationary relative to the hand-held sleeve;

when the change-over switch moves to the second position towards the direction of the first driving mechanism, the change-over switch is matched with the first driving mechanism, the first driving mechanism is locked with the handheld sleeve, and the driving handle is limited in a second working mode.

6. The drive handle for delivering an implant according to claim 5, wherein the first drive mechanism includes a first knob fitted over the hand-held sleeve, the second drive mechanism includes a second knob fitted over the hand-held sleeve, and the first knob and the second knob are both held axially stationary relative to the hand-held sleeve; wherein:

a first limiting part is arranged on one side, facing the second knob, of the first knob, a third limiting part is arranged on the change-over switch, and the first limiting part is used for being matched with the third limiting part so as to limit the first knob to move in the circumferential direction of the handheld sleeve;

7. The drive handle for delivering an implant according to claim 6, wherein the first position-limiting portion is a first position-limiting groove extending axially, the first position-limiting groove is not communicated with the interior of the first knob, and the third position-limiting portion is a first position-limiting protrusion;

8. The drive handle for delivering an implant according to claim 6, wherein the switch is a sleeve structure and is movably disposed between the first knob and the second knob, and the switch is coaxial with the handheld sleeve;

9. The drive handle for delivering an implant according to any of claims 5-8, wherein a fifth position-limiting portion is disposed on the switch, and a sixth position-limiting portion is disposed on the hand-held sleeve; the sixth limiting part is used for being matched with the fifth limiting part to limit the movement of the change-over switch in the circumferential direction of the handheld sleeve.

10. The driving handle for delivering an implant according to claim 9, wherein the fifth limiting portion is a plurality of protrusions symmetrically arranged, the sixth limiting portion is a hollow limiting groove, and all the protrusions are inserted into the corresponding limiting grooves to move the switch along the limiting grooves.

11. The drive handle for delivering an implant according to any of claims 1-8, further comprising first and second connectors disposed on the hand-held sleeve, the first and second connectors being held axially stationary relative to at least the hand-held sleeve; wherein:

the first connecting piece is used for limiting the movement of the first driving mechanism in the axial direction of the handheld sleeve; the second connecting piece is used for limiting the movement of the second driving mechanism in the axial direction of the handheld sleeve.

12. The drive handle for delivering an implant of claim 11, wherein the first connector comprises a first connecting ring disposed on the hand-held sleeve, and the second connector comprises a second connecting ring disposed on the hand-held sleeve; the first connecting ring, the first driving mechanism, the gear switching mechanism, the second driving mechanism and the second connecting ring are sequentially arranged and are coaxial with the handheld sleeve.

13. The drive handle for delivering an implant according to claim 1, wherein the first drive mechanism includes a first knob disposed on the hand-held sleeve, the second drive mechanism includes a second knob disposed on the hand-held sleeve, and both the first knob and the second knob remain axially stationary relative to the hand-held sleeve;

the fixing piece is coaxially arranged with the handheld sleeve and is provided with a first external thread and a second external thread which are axially spaced; the first knob is provided with a first internal thread, and the first external thread is used for being matched with the first internal thread; the second knob is provided with a second internal thread, and the second external thread is used for matching with the second internal thread; the thread pitch of the first external thread is M times of that of the second external thread, and M is an integer greater than or equal to 2.

14. The actuating handle for delivering an implant according to claim 13, wherein the hand-held sleeve is provided with a position avoiding structure for avoiding the first external thread and the second external thread, the position avoiding structure is a hollow limiting groove, and the first external thread passes through the limiting groove to be matched with the first internal thread; the second external thread penetrates through the limiting groove to be matched with the second internal thread, and the fixing piece is used for moving axially along the limiting groove.

15. The drive handle for delivering an implant of claim 13, wherein the first knob has a first recess that avoids the first external thread and the second knob has a second recess that avoids the second external thread;

the driving handle is also provided with an initial mode; when the driving handle is positioned in the initial mode, the first external thread is accommodated in the first groove, and the second external thread is accommodated in the second groove; in the initial mode, the shift position switching mechanism is driven by an external force to limit the drive handle to the first operation mode or the second operation mode.

16. The drive handle for delivering an implant of claim 15, wherein a plurality of graduations are axially disposed on the fixation member, and the distance between any adjacent graduations is equal to the pitch of the first external thread, and an alignment mark is disposed on the hand-held sleeve for registering with any one of the graduations to define the drive handle in the initial mode.

17. The actuating handle for delivering an implant of any of claims 13-16, wherein the securing member is a circular shaft, and wherein the first external thread and the second external thread are each circumferentially disposed along a portion of the circumference of the shaft.

18. The drive handle for delivering an implant of claim 17, wherein the first and second external threads are each a plurality of, all of the first and second external threads being symmetrically disposed about their respective circumferences, and all of the first and second external threads axially coinciding.

19. The drive handle for delivering an implant according to any of claims 1-8, wherein the hand-held sleeve comprises an axially connected hand-held section and a connecting section, the connecting section having a diameter smaller than the diameter of the hand-held section; the first driving mechanism, the second driving mechanism and the gear switching mechanism are all arranged on the connecting section.

20. The drive handle for delivering an implant according to any of claims 1-8, wherein the drive handle is a manual drive handle.

21. A delivery system for delivering an implant, comprising a drive handle for delivering an implant according to any of claims 1-20, and further comprising an outer tube and an inner tube assembly;

22. The delivery system for delivering an implant according to claim 21, wherein the inner tube assembly is threaded through one end of the anchor and threaded out of the other end to connect to the hand-held sleeve.