CN116616955A

CN116616955A - Handle of implantation instrument

Info

Publication number: CN116616955A
Application number: CN202310280090.3A
Authority: CN
Inventors: 阙诗昊; 徐军
Original assignee: Suzhou Huihe Medical Technology Co ltd
Current assignee: Suzhou Huihe Medical Technology Co ltd
Priority date: 2022-11-25
Filing date: 2022-11-25
Publication date: 2023-08-22
Also published as: CN115568981B; CN115568981A

Abstract

The application discloses a handle of an implantation instrument. The handle comprises: a housing; the middle pipe connecting seat is used for being connected with a middle pipe of the conveying sheath pipe and is movably arranged in the shell along the front-back direction; a dissociation knob for connecting with the inner tube of the delivery sheath and rotatably connected to the rear end of the housing; the locking prompting piece is used for prompting whether the implant is locked, a first thread groove and a rebound groove are formed in one part of the middle tube connecting seat and the locking prompting piece, a first connecting tooth is formed in the other part of the middle tube connecting seat and the locking prompting piece, and the rebound groove extends along the front-back direction and is communicated between the last circle of thread groove of the first thread groove and the second circle of thread groove; when the middle pipe connecting seat moves to the final position, the first connecting tooth is positioned in the last circle of thread groove, and can rebound to the second circle of thread groove along with the middle pipe connecting seat through the rebound groove and impact the groove wall of the second circle of thread groove. The application can prevent misoperation and avoid mistakenly releasing the implant under the condition that the implant is not locked.

Description

Handle of implantation instrument

The application is a divisional application of an application patent application with the application number of 202211486695X, which is filed on the 25 th 11 th 2022 day.

Technical Field

The invention belongs to the technical field of medical appliances, and particularly relates to a handle of an implantation appliance, in particular to a handle of a heart implant implantation appliance.

Background

Structural heart disease refers to vascular anatomy and case physiological changes caused by changes in the internal tissues of the heart and the blood vessels from which the anatomical abnormalities originate, and includes congenital, valvular heart disease, cardiomyopathy and macrovascular diseases. For example, for the treatment of mitral regurgitation, there are many products currently on the market that treat mitral regurgitation in an edge-to-edge repair manner.

The implantation instruments for implants for mitral regurgitation generally comprise: the handle and the delivery sheath are two main parts. The delivery sheath is used for delivering the implant to the mitral valve of the left atrium through the cardiac blood vessel, and the implant is controlled to clamp and close the mitral valve through a plurality of series of movements such as sequential movements of the multilayer sheath and the like for logically combining, so that the implant is released. A typical implant includes a front clip assembly and a rear clip assembly, and the delivery sheath is required to perform a series of actions of opening the front clip assembly and the rear clip assembly, respectively, then merging, then closing, locking, etc. The handle is responsible for controlling the delivery sheath to perform some of the actions described above in the correct logical order. The operation is complex, the operation logic is required to be high, misoperation is easy to occur in the operation, and the danger is brought to a patient. For example, if the implant is released by mistake before the front and rear clip assemblies of the heart implant are locked, serious consequences such as the implant coming off the heart valve can result.

Disclosure of Invention

In view of the above, it is an object of the present invention to provide a handle of an implanting instrument capable of preventing erroneous operation.

One aspect of the present invention provides a handle for an implantation instrument for manipulating a delivery sheath to cause a cardiac implant of the implantation instrument to clamp cardiac tissue, the handle comprising:

a housing having a front end and a rear end;

a middle tube connecting seat for connecting with a middle tube of the conveying sheath tube, wherein the middle tube connecting seat is movably arranged in the shell along the front-back direction;

a dissociation knob for connection with an inner tube of the delivery sheath, the dissociation knob rotatably connected to a rear end portion of the housing;

the handle also comprises a locking prompt piece used for prompting whether the implant is locked or not, the locking prompt piece can be movably arranged in the shell along the front-back direction, the locking prompt piece is matched with the middle pipe connecting seat, a first thread groove and a rebound groove are formed in one part of the middle pipe connecting seat and the locking prompt piece, a first connecting tooth is arranged on the other part of the middle pipe connecting seat, the first connecting tooth is inserted into the first thread groove or the rebound groove, the first thread groove is provided with a last circle of thread groove at the rearmost side and a second circle of thread groove adjacent to the last circle of thread groove, the rebound groove extends along the front-back direction and is communicated between the last circle of thread groove and the second circle of thread groove, and when the middle pipe connecting seat moves to the rearmost position, the first connecting tooth is positioned in the last circle of thread groove and can rebound to the second circle of thread groove along with the middle pipe connecting seat and impact the groove wall of the second circle of thread groove.

Preferably, the handle further includes a link core provided in the release knob so as to be movable in a front-rear direction, and a front end portion of the link core is screw-coupled with a rear end portion of the housing; wherein one of the release knob and the interlock core has a locking groove and the other has a locking portion that mates with the locking groove;

the handle has a locking state and a release state, and in the locking state, the locking part is inserted into the locking groove to prevent the release knob from rotating along a set direction relative to the housing; in the detached state, the locking part is disengaged from the locking groove to allow the detaching knob to rotate in a set direction relative to the housing; in the switching process from the locking state to the disconnecting state, the middle pipe connecting seat moves backwards to be connected with the linkage core and drives the linkage core to rotate so that the locking part is separated from the locking groove.

More preferably, the handle further comprises a locking member; the locking state comprises a first locking state and a second locking state, and in the first locking state, the locking piece is positioned at the front side of the linkage core and positioned in a path of backward movement of the middle pipe connecting seat; in the second locked state, the locking member is moved away from the path of movement of the middle tube connecting seat.

More preferably, the locking piece is a safety pin, the shell is provided with a bolt hole, and the middle pipe connecting seat is provided with a blocking part capable of abutting against the safety pin; in the first locking state, the safety pin is inserted into the shell from the bolt hole, the safety pin is positioned at the front side of the linkage core, and the blocking part is positioned at the front side of the safety pin or is abutted with the front surface of the safety pin; in the second locked state, the shear pin is disengaged from the housing.

Further, the handle further comprises:

an operation knob rotatably provided on a front end portion of the housing;

the transmission piece is driven to rotate by the operation knob and is rotatably arranged in the shell;

the middle pipe connecting seat and one part of the transmission piece are provided with a second thread groove and a sliding groove, the other part of the middle pipe connecting seat and the transmission piece is provided with a second connecting tooth, the sliding groove is communicated with the second thread groove and extends backwards or forwards from one end part of the second thread groove, the second connecting tooth is inserted into the second thread groove or the sliding groove, and the middle pipe connecting seat can rotate along with the transmission piece when the second connecting tooth is positioned in the sliding groove;

When the handle is in the first locking state, the second connecting teeth are positioned in the second threaded grooves, and the middle pipe connecting seat can drive the locking prompt piece to move backwards; when the handle is in the second locking state, the second connecting teeth are positioned in the sliding grooves, the middle pipe connecting seat can rotate along with the transmission piece, and the locking prompt piece can move forwards; when the handle is in the detached state, the middle pipe connecting seat can move back and forth until the second connecting groove is positioned at the tail end of the sliding groove, the middle pipe connecting seat automatically rebounds, the groove wall of the first thread groove gives out impact sound, and the second connecting tooth bumps against the groove wall of the second thread groove to give out impact sound.

Furthermore, the locking prompt piece is sleeved on the middle pipe connecting seat, a limiting groove extending along the front-back direction is formed in the inner wall of the shell, the locking prompt piece is provided with a first limiting tooth, and the first limiting tooth is slidably inserted into the limiting groove.

Still further, be equipped with the spacing groove that extends along fore-and-aft direction on the inner wall of shell, well pipe connection seat has the spacing tooth of second, first connection tooth when in the spout the spacing tooth of second breaks away from the spacing groove, well pipe connection seat is in the first thread groove time the spacing tooth of second slidable inserts and locates in the spacing groove.

Further, the locking prompt piece is sleeved on the middle pipe connecting seat, the transmission piece is inserted into the middle pipe connecting seat, the middle pipe connecting seat is provided with the first connecting teeth and the second connecting teeth, the first thread groove and the rebound groove are formed on the inner side wall of the locking prompt piece, the second thread groove and the sliding groove are formed on the outer side wall of the transmission piece, the sliding groove linearly extends backwards from the rear end of the second thread groove, the first connecting teeth extend outwards to be inserted into the first thread groove, and the second connecting teeth extend inwards to be inserted into the second thread groove or the sliding groove; the first connecting teeth are positioned at the rear end part of the rebound groove, and the second connecting teeth are positioned at the rear end part of the sliding groove, so that the middle pipe connecting seat automatically rebounds.

Further, the distance between the last circle of thread grooves and the second circle of thread grooves is gradually increased, and the rebound groove is arranged at the maximum distance between the last circle of thread grooves and the second circle of thread grooves.

Further, the front portion of the groove wall of the rebound groove has a slope so that the width of the front portion of the rebound groove gradually increases from the rear to the front. Even if the first connecting teeth rebound in place, the middle pipe connecting seat can still rotate relative to the locking prompt piece, so that the locking is avoided.

Further, the rotation axis of the transmission member extends in the front-rear direction, and the rotation axis of the operation knob intersects with the rotation axis of the transmission member.

Specifically, the front part of the transmission member has a first conical gear, the inner end of the operation knob is inserted into the housing and has a second conical gear, and the first conical gear and the second conical gear are engaged.

Specifically, the number of the operation knobs is two and the operation knobs are arranged on two opposite sides of the shell.

Preferably, the rear end portion of the middle pipe connecting seat is provided with a cam connecting block, the linkage core is provided with a connecting groove, and the cam connecting block is inserted into the connecting groove in the switching process from the locking state to the disconnecting state of the handle.

Preferably, the front end of the interlocking core has an external thread and the rear end of the housing has a mating internal thread, the external thread and the internal thread being engaged at all times.

Preferably, the front part of the dissociation knob is detachably sleeved on the rear end part of the shell.

Preferably, the locking groove is eccentrically provided on the rear end portion of the dissociation knob; the locking part is an extension section extending backwards of the linkage core, and the extension section is eccentrically arranged.

Preferably, a fixing seat is embedded in the rear part of the middle tube connecting seat so as to be connected with the middle tube of the conveying sheath tube through the fixing seat.

Preferably, the front end portion of the housing is provided with an outer tube connecting member for connecting with the middle tube of the delivery sheath.

Another aspect of the invention provides a method of operating a handle of an insertion instrument as described for non-diagnostic and therapeutic purposes, the method of operation comprising the steps of:

s100, the middle tube connecting seat of the handle moves backwards to the final position of the middle tube connecting seat so as to lock the front clamp assembly and the rear clamp assembly of the heart implant;

the middle pipe connecting seat is connected with the linkage core, the middle pipe connecting seat drives the linkage core to rotate so that the locking part is separated from the locking groove, and the dissociation knob is released;

s200, rotating the dissociation knob along a set direction to disconnect the inner tube and the heart implant, so that the inner tube can be withdrawn.

Preferably, the step S100 specifically includes the following steps:

s101, enabling the middle tube connecting seat to backwards move to abut against a locking piece in the shell so as to close the front clamp assembly of the heart implant to the minimum;

S102, removing the locking piece, and continuing to enable the middle pipe connecting seat to move backwards to the middle position; at the intermediate position, the locking part is inserted into the locking groove, so that the middle pipe connecting seat is rotated, and the dissociation knob is released;

s103, continuously enabling the middle pipe connecting seat to move backwards to the final position of the middle pipe connecting seat, stopping the operation of the middle pipe connecting seat, automatically rebounding forwards by the middle pipe connecting seat, and mutually impacting locking prompt pieces matched with the middle pipe connecting seat to give out impact sound;

s104, judging whether an impact sound is emitted, if so, executing a step S200; if not, step S200 is not performed.

Compared with the prior art, the invention has the following advantages:

the handle of the implantation instrument can move back and forth, the middle tube connecting seat automatically rebounds under the pulling force of the middle tube after the second connecting groove is positioned at the tail end of the chute, so that a click impact sound is generated to prompt medical staff that the heart implant is locked, and the subsequent dissociation operation can be started to release the heart implant and withdraw the delivery sheath tube from the body; if no impact sound is heard, the shortcut force knob can not be rotated, misoperation is prevented, the implant is effectively prevented from being released by mistake under the condition that the implant is not locked, and surgical risks such as mitral valve repair and the like are reduced.

Drawings

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

Fig. 1 is a perspective view of a handle of an insertion instrument with a shear pin, outer tube and outer tube connecting member not shown, according to an embodiment of the present invention.

Fig. 2 is an exploded view of the handle of fig. 1.

Fig. 3 is a structural view of the housing of fig. 2.

Fig. 4 is a structural view of the interlocking core of fig. 2.

Fig. 5 is a structural view of the middle tube connection base in fig. 2.

Fig. 6 is a structural view of the transmission member in fig. 2.

FIG. 7a is a front view of a locking hint in accordance with embodiments of the present invention; fig. 7b and 7c are cross-sectional views in the directions E-E and F-F, respectively, of fig. 7 a.

Fig. 8 is a cross-sectional view of a handle according to an embodiment of the invention, wherein the handle is in a first locked state.

FIG. 9 is a cross-sectional view of the handle with the handle in a first locked state and the blocking portion of the middle tube connection seat abutting the safety pin, in accordance with an embodiment of the present invention;

FIG. 10 is a cross-sectional view of a handle according to an embodiment of the present invention, wherein the handle is switched to a second locked state;

FIG. 11 is a cross-sectional view of a handle according to an embodiment of the present invention, wherein the handle is switched to a detached state;

FIG. 12 is a cross-sectional view of a handle according to an embodiment of the present invention, with the handle in a detached state and the middle tube connection block in its final position;

fig. 13 is a cross-sectional view of a handle according to an embodiment of the present invention, wherein the handle is in a detached state, and wherein the middle tube connection socket has automatically rebounded.

Fig. 14 is a schematic representation of the implantation of a cardiac implant to which the handle of the present invention may be applied.

Fig. 15 is a flow chart of a method of operation according to an embodiment of the present invention.

Reference numerals:

100. a handle; 200. a delivery sheath; 300. an implant;

202. a middle tube; 203. an inner tube; 204. a pull wire;

301. a front clip assembly; 302. a rear clip assembly;

1. a housing; 10. a bolt hole; 11. an internal thread; 12. a limit groove;

2. dissociating the knob; 20. a locking groove;

3. a linkage core; 30. a locking part; 31. an external thread; 32. a connecting groove;

4. a middle pipe connecting seat; 40. a cam connecting block; 41. a blocking portion; 42. a first connection tooth; 43. a second connecting tooth; 44. the second limiting teeth; 45. a fixing seat;

5. A transmission member; 50. a second thread groove; 51. a chute; 52. a first bevel gear;

6. operating a knob; 60. a second bevel gear;

7. locking the prompting piece; 70. a first thread groove; 70a, last circle of thread groove; 70b, a second turn of thread groove; 71. a rebound groove; 71a, transition slope; 72. the first limiting teeth;

8. and a safety pin.

Detailed Description

Preferred embodiments of the present application will be described in detail below with reference to the attached drawings so that the advantages and features of the present application can be more easily understood by those skilled in the art. The description of these embodiments is provided to assist understanding of the present application, but is not intended to limit the present application.

The present embodiments relate to medical devices for structural heart disease intervention, and in particular to handles for implantation devices used in mitral valve edge-to-edge repair procedures. Referring to fig. 1-14, the handle 100 of the heart implant insertion instrument is used to manipulate the delivery sheath 200 to cause the implant 300 to grip heart tissue and withdraw after closing in place. Specifically, the implantation instrument of the heart implant mainly comprises a delivery sheath 200 for carrying the implant 300 and a handle 100 for controlling the delivery sheath 200, the delivery sheath 200 comprising an outer tube (not shown in the figures), a middle tube 202 and an inner tube 203 stacked from inside to outside. As shown in fig. 15, the implant 300 mainly includes a front clip assembly 301 and a rear clip assembly 302, the front clip assembly 301 and the rear clip assembly 302 being capable of being opened and closed, respectively, and the front clip assembly 301 and the rear clip assembly 302 being capable of being moved relatively and being interlocked with each other. The outer tube and the rear clip assembly 302 are detachably connected, the middle tube 202 and the two clip arms 3011 of the front clip assembly 301 are detachably connected, and the inner tube 203 and the main base of the front clip assembly 301 are detachably connected; wherein, the inner tube 203 and the front clamp assembly 301 are connected by screw threads, and can be separated after rotating for a certain number of turns according to a specific direction (such as anticlockwise direction), the middle tube 202 and the clamping arm 3011 of the front clamp assembly 301 are connected by adopting a releasable elastic connecting buckle, when the inner tube 203 is withdrawn from the middle tube 202, the elastic connecting buckle is reset inwards to separate the middle tube 202 and the clamping arm 3011; similarly, the outer tube is also connected to the rear clip assembly 302 using a releasable resilient connector that returns inwardly to disengage the outer tube from the rear clip assembly 302 after the middle tube 202 is withdrawn from the outer tube. Delivery sheath 200 and implant 300 are not essential to the application and may take any configuration known in the art, for example, the distal end of delivery sheath 200 may be provided with a delivery interface for a human heart implant device as disclosed in patent CN113476182B, through which implant 300 is connected, and implant 300 is a medical device with adjustable clamping means as disclosed in patent CN113768554 a.

In this embodiment, as shown in connection with fig. 14, the operating logic for implant 300 generally includes the following actions: (1) After delivery sheath 200 delivers implant 300 to the region of the heart to be placed, middle tube 202 is advanced to open front clamp assembly 301; (2) The middle tube 202 and the inner tube 203 synchronously move forward to drive the front clamp assembly 301 to move forward; releasing the pull wire 204 opens the rear clamp assembly 302 (the rear clamp assembly 302 is in an expanded state in a natural state, the pull wire 204 is pulled back to retract the rear clamp assembly 302 when the delivery sheath 200 is delivered in a blood vessel, and the pull wire 204 is released forwards and the rear frame assembly 302 is opened automatically when the action (2) is performed); (3) Advancing the outer tube to bring the rear clip assembly 302 closer to the front clip assembly 301 until the two are combined; (4) The middle tube 202 is moved back a distance to close the front clamp assembly 301; (5) The middle tube 202 moves back further, so that the front clamp assembly 301 and the rear clamp assembly 302 are locked with each other, specifically, the two clamping arms 3011 and the rear clamp assembly 302 of the front clamp assembly 301 are locked, and the two clamping arms 3011 are clamped between the two elastic arms 3012 of the front clamp assembly 301; (6) The inner tube 203, the middle tube 202, and the outer tube are sequentially disconnected from the implant 300, the implant 300 is released, and the delivery sheath 200 is withdrawn from the patient. The handle 100 of the present embodiment interlocks the control logic corresponding to the above-mentioned operation sequence, and the next operation cannot be performed before the previous operation is completed, so as to effectively prevent the occurrence of misoperation. The handle 100 that executes this operating logic is described in detail below.

As shown in fig. 1, 2 and 8 to 13, the handle 100 includes a housing 1, a release knob 2, a linkage core 3, a middle tube connecting seat 4, a transmission member 5, an operation knob 6 and a locking prompt member 7. The casing 1 has a front end portion and a rear end portion, the release knob 2 is rotatably connected to the rear end portion of the casing 1, the interlocking core 3, the middle pipe connecting seat 4, the transmission member 5 and the locking prompt member 7 are movably provided in the casing 1, and the operation knob 6 is rotatably connected to the front end portion of the casing 1. The front part of the housing 1 is further provided with an outer tube connection member (not shown) for connection with the outer tube of the delivery sheath. The terms "front" and "back" are defined herein in terms of the perspective of the operator (e.g., doctor), with the side farther from the operator being the front, and vice versa.

The middle tube connecting seat 4 is used for connecting with the middle tube 202 of the delivery sheath 200, and the middle tube connecting seat 4 is movably arranged in the shell 1 along the front-back direction. The dissociation knob 2 is adapted to be connected to the inner tube 203 of the delivery sheath 200. The interlock core 3 is provided in the release knob 2 so as to be movable in the front-rear direction, and the front end portion of the interlock core 3 is screwed to the rear end portion of the housing 1. One of the release knob 2 and the interlock core 3 has a locking groove 20 and the other has a locking portion 30 that mates with the locking groove 20. The handle has a locked state in which the locking portion 30 is inserted into the locking groove 20 to prevent the release knob 2 from rotating in a set direction relative to the housing 1; in the detached state, the locking portion 30 is disengaged from the locking groove 20 to allow the detachment knob 2 to rotate in a set direction with respect to the housing 1; in the switching process from the self-locking state to the release state, the middle tube connecting seat 4 moves backward to be connected with the linkage core 3 and drives the linkage core 3 to rotate so that the locking part 30 is separated from the locking groove 20.

The above-mentioned locking state specifically includes a first locking state and a second locking state. The handle also includes a locking member. In the first locking state, the locking piece is positioned at the front side of the linkage core 3 and in the path of the backward movement of the middle pipe connecting seat 4; in the second locked state, the locking member is moved away from the path of movement of the intermediate tube connecting seat 4. Specifically, the locking member is a safety pin 8, the housing 1 is provided with a bolt hole 10, and the middle tube connecting seat 4 is provided with a blocking portion 41 capable of abutting against the safety pin 8. In the first locked state, the shear pin 8 is inserted into the housing 1 from the latch hole 10, the shear pin 8 is located on the front side of the interlock core 3, and the blocking portion 41 is located on the front side of the shear pin 8 or abuts against the front surface of the shear pin 8; in the second locked state, the safety pin 8 is disengaged from the housing 1.

The respective components are described in detail below.

Fig. 3 shows half of the housing 1. Referring to fig. 3, the housing 1 has a long and narrow cylindrical shape as a whole, and a plurality of female screws 11 are provided on an inner wall of a rear end portion of the housing 1. The rear part of the housing 1 is provided with a bolt hole 10. The inner wall of the middle part of the shell 1 is provided with a limit groove 12 extending along the front-back direction. An operation knob 6 is rotatably provided at the front of the housing 1; specifically, the rotational axis of the operation knob 6 is perpendicular to the front-rear direction, and the inner end portion of the operation knob 6 is inserted into the housing 1 and has the second bevel gear 60. In the present embodiment, the number of the operation knobs 6 is two, and are provided on opposite sides, for example, left and right sides, of the housing 1, respectively.

Fig. 4 shows a ganged core 3 that can lock or release the release knob 2 relative to the housing 1 to allow the release knob 2 to rotate in a set release direction (e.g., counter-clockwise). Referring to fig. 4, a locking portion 30 is formed at the rear of the interlock core 3, and the locking portion 30 is embodied as an extension extending rearward and is eccentrically disposed with respect to the rotational axis of the release knob 2 (interlock core 3); in the locked state, the locking portion 30 is inserted rearward into the locking groove 20, and the interlock core 3 and the release knob 2 are not rotatable relative to each other. The front end portion of the interlocking core 3 has an external thread 31, and the external thread 31 is engaged with the internal thread 11 of the rear end portion of the housing 1 at all times. The interlocking core 3 further has a connecting groove 32 that can be fitted to the middle tube connecting seat 4, and the connecting groove 32 is eccentrically provided with respect to the rotational axis of the middle tube connecting seat 4 (the interlocking core 3).

Fig. 5 shows the middle tube connection socket 4. Referring to fig. 5, the rear end portion of the center tube connecting base 4 has a cam connecting block 40 eccentrically disposed with respect to the rotational axis of the center tube connecting base 4. During the switching of the handle 100 from the locked state to the unlocked state, the cam connection block 40 is inserted into the connection groove 32. When the cam connection block 40 is inserted into the connection groove 32 of the linkage core 3, the middle tube connection seat 4 can drive the linkage core 3 to rotate around the self axis line, and the linkage core 3 moves forward along the direction indicated by the arrow a2 in fig. 10 while rotating under the action of the screw thread of the outer shell 1, so that the locking part 30 is separated from the knob 2, the separation knob 2 is released, that is, the handle 100 is converted into a separation state, so that the separation knob 2 is allowed to rotate along the set direction, and the inner tube 203 and the heart implant are disconnected. The rear part of the middle pipe connecting seat 4 is also provided with a blocking part 41, and the blocking part 41 is matched with the safety pin 8; specifically, the blocking portion 41 is a stepped surface formed at the rear of the joint group of the middle pipe 202 and facing the rear side. As shown in connection with fig. 5 and 8 to 13, the intermediate pipe connection block 4 further has first connection teeth 42 and second connection teeth 43, the first connection teeth 42 extending radially outwardly from an outer side surface of the front portion of the intermediate pipe connection block 4, and the second connection teeth 43 extending radially inwardly from an inner side surface of the front portion of the intermediate pipe connection block 4. The middle tube connecting seat 4 also has a second limiting tooth 44, and the second limiting tooth 44 extends radially outwardly from the outer surface of the middle tube connecting seat 4. As shown in fig. 2 and 5, the middle tube connecting seat 4 is embedded with a fixing seat 45, so as to connect the middle tube 202 of the delivery sheath 200 through the fixing seat 45.

Fig. 6 shows a transmission element 5. Referring to fig. 6, the transmission member 5 is provided on an outer side surface thereof with a second screw groove 50 and a slide groove 51, and the slide groove 51 extends straight backward from a rear end of the second screw groove 50 and communicates with the second screw groove 50. The front part of the transmission member 5 has a first conical gear 52, and the first conical gear 52 and the second conical gear 60 mesh. As the operation knob 6 rotates, the transmission member 5 rotates around its own axis. Further, the rotation axis of the transmission member 5 extends in the front-rear direction, and the rotation axis of the operation knob 6 intersects with the rotation axis of the transmission member 5. In this embodiment, the rotation axis of the operation knob 6 and the rotation axis of the transmission member 5 are perpendicular to each other.

Fig. 7a to 7c show the structure of a locking cue 7, the locking cue 7 being used to cue whether the implant is locked. As shown in fig. 2 and 7a to 7c, the locking reminder 7 is embodied as a threaded sleeve which is fitted over the middle tube connection socket 4. The inner side surface of the locking prompt piece 7 is provided with a first thread groove 70 and a rebound groove 71; the first thread groove 70 has a last turn thread groove 70a located at the rearmost side and a second turn thread groove 70b adjacent thereto, and the rebound groove 71 extends in the front-rear direction and communicates between the last turn thread groove 70a and the second turn thread groove 70 b. The distance between the last thread groove 70a and the second thread groove 70b increases gradually from front to rear, and the rebound groove 71 is provided at the maximum distance therebetween. Further, the front portion of the groove wall of the rebound groove 71 has a slope 71a so that the width of the front portion of the rebound groove 71 gradually increases from rear to front. Even if the first connecting teeth 42 of the middle tube connecting seat 4 rebound in place, the middle tube connecting seat 4 can still rotate relative to the locking prompt piece 7 under the action of the inclined plane, so that the locking is avoided. As shown in connection with fig. 7a, 8 to 13, the locking cue 7 also has a first limiting tooth 72, the first limiting tooth 72 extending radially outwards in particular from the outer side surface of the locking cue 7.

As shown in fig. 1, 2, 7b, 7c and 8 to 13, the locking prompt 7 is movably disposed in the housing 1 in the front-rear direction, the locking prompt 7 is engaged with the middle tube connecting seat 4, the second connection tooth 43 of the middle tube connecting seat 4 is inserted into the second screw groove 50 or the rebound groove 71 of the locking prompt 7, and the first connection tooth 42 is located in the last screw groove 70a when the middle tube connecting seat 4 moves to the final position, and can rebound into the second screw groove 70b through the rebound groove 71 and strike the groove wall of the second screw groove 70b along with the middle tube connecting seat 4. In other embodiments, the first thread groove and the rebound groove are also provided on the middle pipe connecting seat 4, and the first connecting tooth is provided on the locking prompt 7. The transmission member 5 is rotated by the operation knob 6, and the transmission member 5 is rotatably disposed in the housing 1. The second coupling tooth 43 of the middle tube coupling seat 4 is inserted into the second screw groove 50 or the slide groove 51, and the middle tube coupling seat 4 can be rotated with the transmission member 5 when the second coupling tooth 43 is positioned in the slide groove 51. The second connecting teeth 43 also collide with the groove wall of the second thread groove 50 of the transmission member 5 to make an impact sound after the intermediate pipe connecting seat 4 automatically rebounds forward. In other embodiments, a second thread groove and a sliding groove may be further provided on the middle tube connecting seat 4, and a second connecting tooth 43 may be provided on the transmission member 5.

When the handle 100 is in the first locking state, the second connecting teeth 43 are located in the second threaded groove 50, and the middle tube connecting seat 4 can drive the locking prompt 7 to move backwards. In the second locked state of the handle 100, the second connecting teeth 43 are located in the sliding groove 51, the middle tube connecting seat 4 can rotate along with the transmission piece 5, and the locking prompt piece 7 can move forwards. When the handle 100 is in the dissociated state, the middle tube connecting seat 4 can move back and forth until the second connecting groove 32 is positioned at the tail end of the sliding groove 51, and the middle tube connecting seat 4 automatically rebounds under the tension of the middle tube 202, so that a clicking impact sound is generated to prompt the medical staff that the heart implant is locked, and the subsequent dissociated operation can be started to release the heart implant and withdraw the delivery sheath 200 from the body.

It should be noted that, the locking prompt 7 is sleeved on the middle pipe connecting seat 4, and the first limiting tooth 72 of the locking prompt 7 is slidably inserted into the limiting groove 12 of the housing 1; when the middle pipe connecting seat 4 rotates, the first limiting teeth 72 are limited by the limiting grooves 12, so that the locking prompt piece 7 can move forwards; when the middle pipe connecting seat 4 moves backwards, the locking prompt piece 7 can move backwards along with the locking prompt piece. The middle pipe connecting seat 4 is provided with a second limiting tooth 44, the second limiting tooth 44 is separated from the limiting groove 12 when the first connecting tooth 42 is in the sliding groove 51, and the second limiting tooth 44 is slidably inserted into the limiting groove 12 when the middle pipe connecting seat 4 is in the first threaded groove 70; therefore, the middle pipe connecting seat 4 can slide back and forth along the limiting groove 12 and can rotate along with the operation knob 6 after being separated from the limiting groove 12.

Further, the transmission member 5 is inserted into the middle tube connecting seat 4, the first connecting teeth 42 of the middle tube connecting seat 4 extend outwardly to be inserted into the first screw grooves 70 of the locking reminder 7, and the second connecting teeth 43 of the middle tube connecting seat 4 extend inwardly to be inserted into the second screw grooves 50 or the sliding grooves 51 of the transmission member 5. When the first connection teeth 42 are located at the rear end of the rebound groove 71 and the second connection teeth 43 are located at the rear end of the slide groove 51, the middle tube connecting seat 4 automatically rebounds.

The front part of the dissociation knob 2 is detachably sleeved on the rear end part of the casing 1. After the dissociation knob 2 rotates a certain number of turns according to the set direction, the inner tube 203 is in contact connection with the heart implant; at this point, pulling the dissociation knob 2 back completely withdraws the inner tube 203 from the heart implant.

The method of operating the handle 100 of the insertion instrument of the present embodiment, for non-diagnostic and therapeutic purposes, is applicable to the handle 100 described above. The operation method comprises the following steps:

s100, the middle tube connecting seat 4 of the handle 100 moves back to the final position so as to lock the front clamp assembly and the rear clamp assembly of the heart implant;

wherein, the middle tube connecting seat 4 is connected with the linkage core 3, the middle tube connecting seat 4 drives the linkage core 3 to rotate, so that the locking part 30 is separated from the locking groove 20, and the dissociation knob 2 is released;

S200, the dissociation knob 2 is turned in the set direction to disconnect the inner tube 203 from the heart implant, so that the inner tube 203 can be withdrawn.

As shown in fig. 15, the step S100 specifically includes the following steps:

s101, enabling the middle tube connecting seat 4 to move backwards to abut against a locking piece in the shell 1 so as to close the front clamp assembly of the heart implant to the minimum;

s102, removing the locking piece, and continuing to enable the middle pipe connecting seat 4 to move backwards to the middle position; in this intermediate position, the locking portion 30 is inserted into the locking groove 20, rotating the middle tube connecting seat 4, releasing the release knob 2;

s103, continuing to enable the middle tube connecting seat 4 to move backwards to the final position, stopping the operation of the middle tube connecting seat 4, automatically rebounding forwards by the middle tube connecting seat 4, and mutually impacting the locking prompt piece 7 matched with the middle tube connecting seat 4 to generate impact sound;

In step S103, the middle tube connecting seat 4 automatically rebounds forward and then collides with the groove wall of the second thread groove 50 of the transmission member 5 to generate an impact sound.

The handle 100 operates generally as follows: rotating the operation knob 6 along the first direction to enable the middle pipe connecting seat 4 to move backwards and drive the middle pipe 202 to move backwards; after the safety pin 8 is removed and the middle tube 202 is driven to move backwards by the middle tube connecting seat when the operation knob 6 is continuously rotated in the first direction, the disconnection knob 2 can be driven to rotate for 6 circles by continuously rotating the operation knob 6. Continuing to rotate the operation knob 6, the middle tube connecting seat stops rotating and moves backwards, and the middle tube connecting seat rebounds after the heart implant is locked. The centrifugal dirty implant is then released after rotating the release knob 2 in a set direction (e.g. counter clockwise).

The specific operation of the handle 100 described above will be described in detail below with reference to the respective states shown in fig. 8 to 13:

(1) Fig. 8 shows an initial position, i.e. a first locking state, in which the operating knob 6 is rotated in a first direction, and the inner tube 203 is moved backward by the backward movement of the middle tube connecting seat 4 until the safety pin 8 (i.e. the middle position of the middle tube connecting seat 4) due to the restriction of the second restriction tooth 44 by the restriction groove 12 and the interaction of the second connection tooth 43 and the second thread groove 50; as shown in fig. 9, this operation closes the front clamp assembly to a minimum because the shear pin 8 is blocked and cannot continue to move rearward. Specifically, the second connecting tooth 43 is in the second thread groove 50, and the second limiting tooth 44 is in the limiting groove 12, so the middle tube connecting seat 4 is not rotatable and only moves backward; at the same time, the first connecting tooth 42 is in the first thread groove 70, so that the locking indicator 7 is moved together backwards.

(2) As shown in fig. 10, the shear pin 8 is pulled out and the handle 100 is in the second locked state. The operation knob 6 is continuously rotated in the first direction, at this time, the second limiting teeth 44 are withdrawn from the limiting grooves 12, and the second connecting teeth 43 enter the front end of the sliding groove 51, so that the middle tube connecting seat is not continuously moved backward, but is rotated. At this time, the locking portion 30 of the middle tube connecting seat 4 is inserted into the locking groove 20 of the linkage core 3, and the middle tube connecting seat 4 rotates for 6 circles, so that the linkage core 3 is driven to rotate, and due to the cooperation with the threads of the housing 1, the linkage core 3 moves forward in the direction indicated by the arrow a2 in fig. 10 and drives the release knob 2 to rotate for 6 circles in the direction indicated by the arrow a1 in fig. 10 when rotating. At the same time, rotation of the middle tube connector 4 will move the locking reminder 7 forward to the bottom in the direction indicated by arrow a3 in fig. 10.

After 6 turns, as shown in fig. 11, the interlock core 3 is withdrawn from the release knob 2 and the locking reminder 7 is moved forward to the bottom. At this time, the handle 100 is switched to the detached state.

(3) Continuing to rotate the operating knob 6 in the first direction, since the locking reminder 7 is going to the bottom and since the first connection tooth 42 of the middle tube connection holder 4 is inserted into the first thread groove 70 of the locking reminder 7 as shown in fig. 12, the middle tube connection holder 4 will move back to its final position until the first connection tooth 42 enters the last turn of thread groove 70a, at which time the middle tube connection holder 4 will move forward due to the pulling force of the middle tube 202 to release the stress of the middle tube 202 (at which time the clamping member should be locked and the handle 100 will make a click sound while the first connection tooth 42 slides directly into the second turn of thread groove 70b via the rebound groove 71 at the end of the last turn of thread groove 70 a), i.e. the click sound generated by the first connection tooth 42 going back to the second turn of thread groove 70b hitting the groove wall and the first connection tooth 43 going back to the second thread groove 50 hitting the groove wall, at which time the inner tube 203 and the heart implant are detached by rotating the rotary dissociation knob 2 as shown in fig. 13.

It should be noted that, unless otherwise specified, when a feature is referred to as being "fixed" or "connected" to another feature, it may be directly or indirectly fixed or connected to the other feature. Further, the descriptions of the upper, lower, left, right, etc. used in the present invention are merely with respect to the mutual positional relationship of the constituent elements of the present invention in the drawings, and reference is made to fig. 8.

It is further understood that the term "plurality" in this disclosure means two or more, and other adjectives are similar thereto. "and/or", describes an association relationship of an association object, and indicates that there may be three relationships, for example, a and/or B, and may indicate: a exists alone, A and B exist together, and B exists alone.

It is further understood that the terms "first," "second," and the like are used to describe various information, but such information should not be limited to these terms. These terms are only used to distinguish one type of information from another and do not denote a particular order or importance. Indeed, the expressions "first", "second", etc. may be used entirely interchangeably. For example, first information may also be referred to as second information, and similarly, second information may also be referred to as first information, without departing from the scope of the present disclosure.

The above-described embodiments are provided for illustrating the technical concept and features of the present invention, and are intended to be preferred embodiments for those skilled in the art to understand the present invention and implement the same according to the present invention, not to limit the scope of the present invention. All equivalent changes or modifications made according to the principles of the present invention should be construed to be included within the scope of the present invention.

Claims

1. A handle of an implantation instrument for manipulating a delivery sheath to cause a cardiac implant of the implantation instrument to clamp cardiac tissue, the handle comprising:

a housing having a front end and a rear end;

the handle also comprises a locking prompt piece used for prompting whether the implant is locked or not, the locking prompt piece can be movably arranged in the shell along the front-back direction, the locking prompt piece is matched with the middle pipe connecting seat, a first thread groove and a rebound groove are formed in one part of the middle pipe connecting seat and the locking prompt piece, a first connecting tooth is arranged on the other part of the middle pipe connecting seat, the first connecting tooth is inserted into the first thread groove or the rebound groove, the first thread groove is provided with a last circle of thread groove at the rearmost side and a second circle of thread groove adjacent to the last circle of thread groove, the rebound groove extends along the front-back direction and is communicated between the last circle of thread groove and the second circle of thread groove, and when the middle pipe connecting seat moves to the rearmost position, the first connecting tooth is positioned in the last circle of thread groove and can rebound to the second circle of thread groove along with the middle pipe connecting seat.

2. The handle of an insertion instrument according to claim 1, further comprising a link core provided in the release knob movably in a front-rear direction, and a front end portion of the link core and a rear end portion of the housing are screw-connected; wherein one of the release knob and the interlock core has a locking groove and the other has a locking portion that mates with the locking groove;

3. The handle of an insertion instrument of claim 2, wherein the handle further comprises a locking member; the locking state comprises a first locking state and a second locking state, and in the first locking state, the locking piece is positioned at the front side of the linkage core and positioned in a path of backward movement of the middle pipe connecting seat; in the second locked state, the locking member is moved away from the path of movement of the middle tube connecting seat.

4. A handle of an insertion instrument according to claim 3, wherein the locking member is a safety pin, the housing is provided with a bolt hole, and the middle tube connecting seat is provided with a blocking part capable of abutting against the safety pin; in the first locking state, the safety pin is inserted into the shell from the bolt hole, the safety pin is positioned at the front side of the linkage core, and the blocking part is positioned at the front side of the safety pin or is abutted with the front surface of the safety pin; in the second locked state, the shear pin is disengaged from the housing.

5. The handle of an insertion instrument of claim 3, wherein the handle further comprises:

an operation knob rotatably provided on a front end portion of the housing;

When the handle is in the first locking state, the second connecting teeth are positioned in the second threaded grooves, and the middle pipe connecting seat can drive the locking prompt piece to move backwards; when the handle is in the second locking state, the second connecting teeth are positioned in the sliding grooves, the middle pipe connecting seat can rotate along with the transmission piece, and the locking prompt piece can move forwards; when the handle is in the detached state, the middle pipe connecting seat can move back and forth until the second connecting teeth are positioned at the tail end of the sliding groove, the middle pipe connecting seat automatically rebounds, the first connecting teeth impact the groove wall of the first thread groove to generate impact sound, and the second connecting teeth impact the groove wall of the second thread groove to generate impact sound.

6. The handle of the implantation instrument according to claim 5, wherein the locking prompt piece is sleeved on the middle tube connecting seat, a limiting groove extending along the front-back direction is arranged on the inner wall of the shell, the locking prompt piece is provided with a first limiting tooth, and the first limiting tooth is slidably inserted into the limiting groove.

7. The handle of an insertion instrument according to claim 5, wherein a limiting groove extending in the front-rear direction is provided on an inner wall of the housing, the middle tube connecting seat has a second limiting tooth, the second limiting tooth is disengaged from the limiting groove when the first connecting tooth is in the sliding groove, and the second limiting tooth is slidably inserted into the limiting groove when the middle tube connecting seat is in the first threaded groove.

8. The handle of an insertion instrument according to claim 5, wherein the locking tip is fitted over the middle tube connecting seat, the transmission member is inserted into the middle tube connecting seat, the middle tube connecting seat has the first connecting teeth and the second connecting teeth, the first screw groove and the rebound groove are formed on the inner side wall of the locking tip, the second screw groove and the sliding groove are formed on the outer side wall of the transmission member, the sliding groove extends linearly rearward from the rear end of the second screw groove, the first connecting teeth extend outward to be inserted into the first screw groove, and the second connecting teeth extend inward to be inserted into the second screw groove or the sliding groove; the first connecting teeth are positioned at the rear end part of the rebound groove, and the second connecting teeth are positioned at the rear end part of the sliding groove, so that the middle pipe connecting seat automatically rebounds; the distance between the last circle of thread grooves and the second circle of thread grooves is gradually increased, and the rebound groove is arranged at the maximum distance between the last circle of thread grooves and the second circle of thread grooves; the front portion of the groove wall of the rebound groove is provided with an inclined surface, so that the width of the front portion of the rebound groove gradually increases from the rear to the front.

9. The handle of an insertion instrument according to claim 5, wherein a rotational axis of the transmission member extends in the front-rear direction, and the rotational axis of the operation knob intersects with the rotational axis of the transmission member.

10. The handle of an insertion instrument according to claim 9, wherein a front portion of the transmission member has a first conical gear, an inner end portion of the operation knob is inserted into the housing and has a second conical gear, the first conical gear and the second conical gear are engaged; the number of the operation knobs is two, and the operation knobs are arranged on two opposite sides of the shell.

11. The handle of an insertion instrument according to claim 1, wherein a cam connection block is provided at a rear end portion of the middle tube connection seat, the linkage core is provided with a connection groove, and the cam connection block is inserted into the connection groove during switching from the locked state to the released state; the front end of the linkage core is provided with external threads, the rear end of the shell is provided with matched internal threads, and the external threads and the internal threads are always meshed.

12. The handle of an insertion instrument of claim 1, wherein a front portion of the dissociation knob is removably received over a rear end portion of the housing; the locking groove is eccentrically arranged on the rear end part of the dissociation knob; the locking part is an extension section extending backwards of the linkage core, and the extension section is eccentrically arranged.

13. The handle of the implantation instrument according to claim 1, wherein a fixing seat is embedded in the rear part of the middle tube connecting seat so as to connect the middle tube of the delivery sheath through the fixing seat; the front end of the outer shell is provided with an outer tube connecting part for connecting with the middle tube of the conveying sheath tube.