Operating handle for a cardiac implant implantation instrument and interlock release mechanism thereof

Abstract

The application discloses an operating handle of a heart implant implanting instrument and an interlocking disengaging mechanism thereof. The operating handle comprises a stroke seat, a middle tube connecting seat, an inner tube connecting assembly, and the interlocking disengaging mechanism is arranged between the middle tube connecting seat and the inner tube connecting assembly. The middle tube connecting seat has a connecting portion, the inner tube connecting assembly comprises an inner connecting sleeve and an inner tube connecting seat, the rear end of the inner connecting sleeve is fixedly connected with the inner tube connecting seat, an inner tube is fixed on the inner tube connecting seat, and the inner connecting sleeve has a connecting groove matched with the connecting portion. The interlocking disengaging mechanism has a locking state and a disengaging state. In the locking state, the connecting portion is inserted into the connecting groove to prevent the inner connecting sleeve from moving relative to the middle tube connecting seat. In the disengaging state, the connecting portion is separated from the connecting groove to allow the inner tube connecting seat to move backward relative to the middle tube connecting seat. The application can effectively reduce misoperation and avoid disengaging the middle tube connecting seat and the inner tube connecting assembly before the implant is not closed or locked.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, and particularly relates to an operating handle of a heart implant implantation device and an interlocking disengagement mechanism thereof. BACKGROUND

[0002] Structural heart disease refers to changes in blood vessel anatomy and case physiology caused by changes in internal tissues and blood vessels of the heart caused by anatomical abnormalities, including congenital, valvular heart disease, cardiomyopathy and large vessel disease. For example, for the treatment of mitral regurgitation, there are many products on the market to treat mitral regurgitation in the form of edge-to-edge repair.

[0003] The implantation device for the implant for mitral regurgitation generally includes an operating handle and a delivery sheath. The delivery sheath is used to deliver the implant to the mitral valve of the left atrium through the cardiovascular system, and through a series of movement logic combinations such as the movement of the multi-layer sheath, the implant is controlled to clamp and close the mitral valve and then release the implant. A typical implant includes a front clamp assembly and a rear clamp assembly, and the delivery sheath needs to perform a series of actions such as opening the front clamp assembly and the rear clamp assembly respectively, then combining, and then closing. The operating handle is responsible for controlling the delivery sheath to perform the above actions in the correct logic sequence. The operation is complex, and there is a high requirement for the operation logic. Misoperation is easy to occur in surgery, which brings danger to the patient. For example, if the implant is released before the action of closing the front clamp assembly to the minimum is performed, the implant will be separated from the heart valve, which will cause serious consequences. SUMMARY

[0004] In view of the above problems, one object of the present application is to provide an interlocking disengagement mechanism of an operating handle of a heart implant implantation device, which effectively reduces misoperation and avoids disengaging the middle tube connecting seat and the inner tube connecting assembly before the implant is closed or locked.

[0005] Another object of the present application is to provide an operating handle of a heart implant implantation device to prevent misoperation.

[0006] According to one aspect of the present application, an interlock disengagement mechanism of a handle of a cardiac implant implantation instrument, the handle being used to manipulate a delivery sheath to hold the implant against a heart tissue, the handle comprising a housing and a middle tube connector and an inner tube connector assembly for connecting with a middle tube and an inner tube of the delivery sheath respectively, the interlock disengagement mechanism being disposed between the middle tube connector and the inner tube connector assembly, the middle tube connector having a connecting portion, the inner tube connector assembly comprising an inner connector sleeve and an inner tube connector seat, a rear end of the inner connector sleeve being fixedly connected with the inner tube connector seat, an inner tube being fixed to the inner tube connector seat, the inner connector sleeve having a connecting groove cooperating with the connecting portion; the interlock disengagement mechanism having a locked state and a disengaged state, in the locked state, the connecting portion is inserted into the connecting groove to prevent the inner connector sleeve from moving relative to the middle tube connector; in the disengaged state, the connecting portion is disengaged from the connecting groove to allow the inner tube connector seat to move rearward relative to the middle tube connector.

[0007] Preferably, the interlock disengagement mechanism comprises an outer operation sleeve, the outer operation sleeve being sleeved on the inner connector sleeve, the inner tube connector seat being movably disposed in the outer operation sleeve along a center line; in the disengaged state, the outer operation sleeve is configured to move rearward relative to the inner connector sleeve.

[0008] More preferably, the outer operation sleeve is rotatably sleeved on the inner connector sleeve about the center line, the outer operation sleeve being provided with a connecting tooth, the inner connector sleeve being provided with a first external thread, the connecting tooth being movably inserted into the first external thread along the first external thread, in the locked state, the connecting tooth being at a front end of the first external thread or between two end portions of the first external thread, in the disengaged state, the connecting tooth being at a rear end of the first external thread; or, the outer operation sleeve being provided with an internal thread, the inner connector sleeve being provided with a connecting tooth, the connecting tooth being movably inserted into the external thread along the external thread.

[0009] Further, the locked state comprises a first locked state and a second locked state, the interlock disengagement mechanism further comprising a second locking member, the second locking member being located between the connecting portion and the outer operation sleeve and having a first position and a second position located a distance rearward of the first position, in the first locked state, the second locking member being located at the first position, a front end of the second locking member abutting against the connecting portion, and a rear end of the second locking member abutting against the outer operation sleeve; in the switching process from the first locked state to the second locked state, the outer operation sleeve moves rearward relative to the inner connector sleeve to allow the second locking member to move rearward; in the disengaged state, the second locking member being located at the second position.

[0010] Further, the second locking member is an interlocking push rod, the interlocking push rod is located in the inner connecting sleeve, and a rear end of the interlocking push rod penetrates through the inner connecting sleeve and can abut against a rear end of the outer operating sleeve.

[0011] Preferably, the operating handle further comprises a stroke seat, the stroke seat is movably connected to the outer shell along the center line, and the middle tube connecting seat is movably arranged on the stroke seat along the center line; a front part of the inner connecting sleeve is provided with an inner thread, a rear end of the stroke seat is provided with a second outer thread matched with the inner thread, the inner thread and the second outer thread are connected when the interlocking disengaging mechanism is in the locked state, and the inner thread and the second outer thread are disengaged when the interlocking disengaging mechanism is in the disengaged state.

[0012] According to another aspect of the present application, an operating handle of a heart implant implanting instrument is used for operating a delivery sheath tube to clamp heart tissue by the implant, the operating handle comprises an outer shell and outer tube connecting seat, middle tube connecting seat and inner tube connecting assembly for connecting with outer tube, middle tube and inner tube of the delivery sheath tube respectively, the outer shell has a center line extending along a length direction of the delivery sheath tube; characterized in that the operating handle further comprises the interlocking disengaging mechanism as claimed in any one of claims 1 to 6.

[0013] Preferably, the operating handle further comprises a stroke seat, the stroke seat is movably connected to the outer shell along the center line, and the middle tube connecting seat is movably arranged on the stroke seat along the center line; a front part of the inner connecting sleeve is provided with an inner thread, a rear end of the stroke seat is provided with a second outer thread matched with the inner thread, the inner thread and the second outer thread are connected when the interlocking disengaging mechanism is in the locked state, and the inner thread and the second outer thread are disengaged when the interlocking disengaging mechanism is in the disengaged state.

[0014] More preferably, the interlocking disengaging mechanism comprises an outer operating sleeve sleeved on the inner connecting sleeve; the locking state comprises a first locking state and a second locking state, the interlocking disengaging mechanism further comprises a second locking member located between the connecting portion and the outer operating sleeve and having a first position and a second position located a distance behind the first position, the interlocking disengaging mechanism in the first locking state, the second locking member is located at the first position, and the front end of the second locking member abuts against the connecting portion, and the rear end abuts against the outer operating sleeve; in the switching process from the first locking state to the second locking state, the outer operating sleeve moves backward relative to the inner connecting sleeve to push the second locking member to the second position, and the middle tube connecting seat then rebounds to disengage the connecting portion from the inner connecting sleeve; when the interlocking disengaging mechanism is in the disengaged state, the second locking member is located at the second position.

[0015] Further, the operating handle further comprises a first threaded tube rotatably arranged in the shell about the center line and a first operating knob for driving the first threaded tube to rotate, the first operating knob is rotatably arranged on the shell, the rotation axis of the first operating knob intersects with the center line, the first threaded tube has a third external thread, the third external thread has a last side first thread and a second thread adjacent to the first thread, and the first thread and the second thread have a rebound groove communicating therebetween; the middle tube connecting seat has a connecting lug, the connecting lug is movably inserted into the third external thread along the third external thread and the rebound groove.

[0016] The present application adopts the above scheme and has the following advantages compared with the prior art:

[0017] The operating handle, implanting instrument and operating method of the present application set an interlocking disengaging mechanism between the middle tube connecting seat and the inner tube connecting assembly, the inner tube connecting assembly and the middle tube connecting seat are bound before the interlocking disengaging mechanism is disengaged, it is ensured that all actions of the middle tube connecting seat are performed before the inner tube connecting assembly is disengaged, at this time, the inner tube can be operated to release the heart implant or further withdraw the delivery sheath tube, logical interlocking is performed, misoperation is prevented, and the risk of mitral valve repair surgery is reduced. BRIEF DESCRIPTION OF DRAWINGS

[0018] In order to more clearly illustrate the technical solutions of the present application, the following will briefly introduce the drawings needed in the embodiment description. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can also be obtained by those skilled in the art without creative labor.

[0019] Figure 1 Fig. 1 is a perspective view of an implantation device for a cardiac implant according to an embodiment of the present application.

[0020] Figure 2 Fig. 2 is a perspective view of the implantation device of Fig. 1 with the operating handle in a first position. Figure 1 Fig. 3 is a cross-sectional view of the implantation device of Fig. 1.

[0021] Figure 3 Fig. 4 is a cross-sectional view of the operating handle front portion according to an embodiment of the present application.

[0022] Figure 4 Fig. 5 is a cross-sectional view of the operating handle front portion according to an embodiment of the present application.

[0023] Figure 5 Fig. 6 is a schematic view of the position of the safety pin removal front middle tube connector seat at the rightmost position and the first threaded tube according to an embodiment of the present application.

[0024] Figure 6 Fig. 7 is a schematic view of the position of the safety pin removal rear middle tube connector seat at the rightmost position and the first threaded tube according to an embodiment of the present application.

[0025] Figure 7 Fig. 8 is a schematic view of the position of the middle tube connector seat after spring back and the first threaded tube according to an embodiment of the present application.

[0026] Figure 8 Fig. 9 is a schematic view of the structure of the operating handle rear portion according to an embodiment of the present application, wherein the interlock disengagement mechanism is switched from the first locked state to the second locked state or from the second locked state to the disengaged state.

[0027] Figure 9 Fig. 10 is a schematic view of the structure of the operating handle rear portion according to an embodiment of the present application, wherein the interlock and force mechanism is in the disengaged state.

[0028] Figure 10 Fig. 11 is a schematic view of the structure of the inner tube connector assembly and the interlock push rod according to an embodiment of the present application.

[0029] Figure 11 Fig. 12 is a schematic view of the structure of the inner connector sleeve according to an embodiment of the present application.

[0030] Figure 12 Fig. 13 is a schematic view of the structure of the inner tube connector seat and the inner tube rear end portion connection according to an embodiment of the present application.

[0031] Figure 13 Fig. 14 is a schematic view of the structure of the disengagement knob according to an embodiment of the present application.

[0032] Figure 14 Fig. 15 is a schematic view of the structure of the interlock push rod according to an embodiment of the present application.

[0033] Figure 15 Fig. 16 is a schematic view of the application of a cardiac implant.

[0034] Reference signs:

[0035] 100, operating handle; 200, delivery sheath; 300, implant;

[0036] 201, outer tube; 202, middle tube; 203, inner tube; 204, pull wire;

[0037] 301, front clip assembly; 302, rear clip assembly;

[0038] 1, housing; 11, viewing window;

[0039] 2, outer tube connector; 21, third threaded tube; 22, third operating knob; 23, operating lever; 24, rear clip assembly position indicating rod;

[0040] 3, stroke seat; 30, second external thread; 31, second threaded tube; 32, second operating knob; 33, front clip assembly position indicating rod;

[0041] 4, middle tube connector; 40, limiting part; 41, connecting part; 42, first threaded tube; 420, third external thread; 420a, first circle of thread; 420b, second circle of thread; 421, rebounding groove; 43, first operating knob; 44, connecting lug;

[0042] 5, inner tube connector assembly; 51, inner connecting sleeve; 510, first external thread; 511, internal thread; 512, connecting groove; 513, latch hole; 52, inner tube connector;

[0043] 6, interlocking dissociation mechanism; 61, latch; 62, dissociation knob; 621, connecting tooth; 622, latch hole; 63, interlocking push rod; 631, rear end part;

[0044] C, center line. DETAILED DESCRIPTION

[0045] The preferred embodiments of the present application will be described in detail with reference to the drawings, so that the advantages and features of the present application can be more easily understood by those skilled in the art. It is noted that the description of the embodiments is for the purpose of helping to understand the present application, but does not constitute a limitation of the present application.

[0046] The present embodiment relates to medical devices for structural heart disease intervention, in particular, an operating handle for a heart implant used in a mitral valve edge-to-edge repair operation and an implantation device having the same. Referring to Figures 1 to 15As shown, the operation handle 100 of the heart implant is used to control the delivery sheath 200 to clamp the implant 300 to the heart tissue and withdraw after closing in place. Specifically, the implant instrument of the heart implant mainly includes the delivery sheath 200 for carrying the implant 300 and the operation handle 100 for controlling the delivery sheath 200, and the delivery sheath 200 includes an outer tube 201, a middle tube 202 and an inner tube 203 stacked from inside to outside. As shown in the figure, the delivery sheath 200 is connected to the operation handle 100, and the operation handle 100 is connected to the implant 300. Figure 15 As shown, the implant 300 mainly includes a front clamp assembly 301 and a rear clamp assembly 302, the front clamp assembly 301 and the rear clamp assembly 302 can be opened and closed respectively, the front clamp assembly 301 and the rear clamp assembly 302 can also be relatively moved and locked. The outer tube 201 and the rear clamp assembly 302 are detachably connected, the middle tube 202 and the two clamping arms 3011 of the front clamp assembly 301 are detachably connected, and the inner tube 203 and the main base of the front clamp assembly 301 are detachably connected; wherein the inner tube 203 and the front clamp assembly 301 are connected through threads, and after rotating a certain number of turns in a specific direction (such as counterclockwise), the two can be separated, the middle tube 202 and the clamping arm 3011 of the front clamp assembly 301 are connected through a spring buckle that can be buckled off, when the inner tube 203 is withdrawn from the middle tube 202, the spring buckle resets inward to make the middle tube 202 and the clamping arm 301 separate; similarly, the outer tube 201 and the rear clamp assembly 302 are also connected through a spring buckle that can be buckled off, when the middle tube 202 is withdrawn from the outer tube 201, the spring buckle resets inward to make the outer tube 201 and the rear clamp assembly 302 separate. The delivery sheath 200 and the implant 300 are not the key points of the application, and known structures in the prior art can be used, for example, the distal end of the delivery sheath 200 is provided with a human heart implant instrument delivery interface disclosed in patent document CN113476182B, the implant 300 is connected through the interface, and the implant 300 is a medical instrument with adjustable clamping disclosed in patent document CN113768554A.

[0047] In this embodiment, in combination with Figure 15As shown, the operation logic of the implant 300 generally includes the following actions: (1) after the delivery sheath 200 sends the implant 300 to the area to be placed in the heart, the middle tube 202 is moved forward to drive the front clip assembly 301 to open; (2) the middle tube 202 and the inner tube 203 are moved forward synchronously to drive the front clip assembly 301 to move forward; the release of the pull wire 204 opens the rear clip assembly 302 (the rear clip assembly 302 is in an unfolded state in the natural state, and the pull wire 204 is pulled back to retract the rear clip assembly 302 when the delivery sheath 200 is delivered in the blood vessel, and when the action (2) is performed, the pull wire 204 is released forward, and the rear clip assembly 302 is automatically opened); (3) the outer tube 201 is moved forward to make the rear clip assembly 302 close to the front clip assembly 301 until they merge; (4) the middle tube 202 is moved backward by a distance to make the front clip assembly 301 close; (5) the middle tube 202 is further moved backward to make the front clip assembly 301 and the rear clip assembly 302 lock with each other, specifically, the two clamping arms 3011 of the front clip assembly 301 and the rear clip assembly 302 are locked, and the two clamping arms 3011 are clamped between the two elastic arms 3012 of the front clip assembly 301; (6) the inner tube 203, the middle tube 202, and the outer tube 201 are sequentially disconnected from the implant 300, the implant 300 is released, and the delivery sheath 200 is withdrawn from the patient's body. The operation handle 100 of the present embodiment interlocks the control logic corresponding to the above-mentioned action sequence, and the next operation cannot be performed before the previous operation is completed, effectively preventing the occurrence of misoperation. The operation handle 100 performing the operation logic will be described in detail below.

[0048] Referring to Figure 2 , Figure 3 and Figure 4 , the operation handle 100 includes a housing 1 and an outer tube connecting seat 2, a middle tube connecting seat 4, and an inner tube connecting assembly 5 for connecting the outer tube 201, the middle tube 202, and the inner tube 203 of the delivery sheath 200, respectively, which are arranged in sequence from front to back. The housing 1 has a center line C extending in the length direction of the delivery sheath 200. In this document, the orientation words "front" and "back" are defined from the perspective of the operator, with the side farther from the operator being the front, and vice versa.

[0049] The operation handle 100 further comprises a stroke seat 3 located at the rear of the outer tube connecting seat 2, the stroke seat 3 is movably connected to the outer shell 1 along the center line C, the middle tube connecting seat 4 is movably arranged on the stroke seat 3 along the center line C, and an interlocking disengaging mechanism 6 is arranged between the inner tube connecting assembly 5 and the stroke seat 3. The interlocking disengaging mechanism 6 has a locking state (including a first locking state and a second locking device) and a disengaging state. In the first locking state, the rear end of the stroke seat 3 and the inner tube connecting assembly 5 are connected and locked by the interlocking disengaging mechanism 6, and the middle tube connecting seat 4 can move within the first stroke; in the second locking state, the rear end of the stroke seat 3 and the inner tube connecting assembly 5 are connected and locked by the interlocking disengaging mechanism 6, and the middle tube connecting seat 4 can move within the second stroke located at the rear side of the first stroke; in the disengaging state, the inner tube connecting assembly 5 is released to be able to move backward along the center line C relative to the stroke seat 3 and the middle tube 202 fixing seat. Before performing the above-mentioned action (5), the interlocking disengaging mechanism 6 is always in the first locking state; when performing action (5), the interlocking disengaging mechanism 6 switches to the second locking state; when performing action (6), the interlocking disengaging mechanism 6 switches to the disengaging state. The middle tube connecting seat 4 has two strokes, before the safety pin is removed, the displacement stroke (first stroke) of the middle tube connecting seat 4 is only enough to make the front clamp assembly 301 and the rear clamp assembly 302 of the implant 300 close, after the safety pin is removed, the middle tube connecting seat 4 can continue to move backward and lock the front clamp assembly 301 and the rear clamp assembly 302, and finally reach the bottom and rebound to release the tension in the middle tube 202. Figure 5 The end point of the middle layer tube connecting seat 4 within the first stroke is shown; Figure 6 and Figure 7 The end point and the starting point of the middle layer tube connecting seat 4 within the second stroke are shown respectively.

[0050] Combined Figure 3 , Figure 8 and Figure 9As shown, the interlocking disengaging mechanism 6 includes a first locking member, the first locking member is located at the rear of the stroke seat 3 or abuts against the stroke seat 3 when the interlocking disengaging mechanism 6 is in the first locking state; the first locking member is away from the rear of the stroke seat 3 when the interlocking disengaging mechanism 6 is in the second locking state and the disengaging state. Specifically, the first locking member is a latch 61, the inner tube connecting assembly 5 is provided with a latch hole 513 for the latch 61 to insert, and the middle tube connecting seat 4 is further provided with a limiting portion 40 for cooperating with the latch 61. When the interlocking disengaging mechanism 6 is in the first locking state, the front end of the inner tube connecting assembly 5 is sleeved on the rear end of the stroke seat 3, the latch 61 is inserted into the latch hole 513, and the limiting portion 40 is located in front of or abuts against the latch 61; when the interlocking disengaging mechanism 6 is in the second locking state and the disengaging state, the latch 61 is disengaged from the latch hole 513. The distance of the rearward movement of the middle tube connecting seat 4 is limited by the safety latch 61, and the corresponding position of the safety latch 61 is that the implant 300 is closed to the minimum angle (i.e., the distance between the clamping arm 3011 of the front clamping assembly 301 and the rear clamping assembly 302 is the smallest). The inner tube connecting assembly 5 is connected to the end of the stroke seat 3 through the interlocking disengaging mechanism 6, and can move forward and backward with the stroke seat 3. Before the safety latch 61 is removed, the inner tube 203 can be regarded as being bound to move with the stroke seat 3.

[0051] The middle tube connecting seat 4 is further provided with a connecting portion 41. As shown, Figure 8 and Figure 9 As shown, the inner tube connecting assembly 5 includes an inner connecting sleeve 51 and an inner tube connecting seat 52, the front end of the inner connecting sleeve 51 is sleeved on the rear end of the stroke seat 3, the rear end of the inner connecting sleeve 51 is fixedly connected with the inner tube connecting seat 52, and the inner tube 203 is fixed on the inner tube connecting seat 52. The inner connecting sleeve 51 is provided with a connecting groove 512 for cooperating with the connecting portion 41. When the interlocking disengaging mechanism 6 is in the first locking state and the second locking state, the connecting portion 41 is inserted into the connecting groove 512 to prevent the inner connecting sleeve 51 from moving relative to the middle tube 202 fixed seat; when the interlocking disengaging mechanism 6 is in the disengaging state, the connecting portion 41 is disengaged from the connecting groove 512 to allow the inner tube connecting seat 52 to move relative to the middle tube 202 fixed seat.

[0052] The interlocking disengaging mechanism 6 includes an outer operating sleeve, the outer operating sleeve is sleeved on the inner connecting sleeve 51, and the inner tube connecting seat 52 is movably arranged in the outer operating sleeve along the center line C. The outer operating sleeve is rotatably sleeved on the inner connecting sleeve 51 about the center line C; when the interlocking disengaging mechanism 6 is in the disengaging state, the outer operating sleeve is configured to be able to move rearward relative to the inner connecting sleeve 51; when the interlocking disengaging mechanism 6 is in the disengaging state, the outer operating sleeve is configured to be able to drive the inner connecting sleeve 51 to move rearward. Specifically, the outer operating sleeve is a disengaging knob 62. The above-mentioned latch hole 513 is arranged on the inner connecting sleeve 51, and the disengaging knob 62 is also provided with a latch hole 622, and the latch 61 can be inserted into the latch hole 513 and the latch hole 622.

[0053] Referring toFigures 8 to 14 As shown, the interlock release mechanism 6 also includes a second locking element. Specifically, the second locking element is an interlock push rod 63, which is located inside the inner connecting sleeve 51. The rear end 631 of the interlock push rod 63 passes through the inner connecting sleeve 51 and can abut against the rear end of the release knob 62. The interlock push rod 63 is located between the connecting part 41 and the release knob 62 and has a first position and a second position located a distance behind the first position. In the first locked state, the interlock release mechanism 6 has the interlock push rod 63 in the first position, with the front end of the interlock push rod 63 abutting against the connecting part 41 and the rear end 631 abutting against the release knob 62. During the switching process from the first locked state to the second locked state, the release knob 62 moves backward relative to the inner connecting sleeve 51 to allow the interlock push rod 63 to move backward. When the interlock release mechanism 6 is in the released state, the interlock push rod 63 is in the second position.

[0054] Specifically in this embodiment, combined with Figure 8 , Figure 9 , Figure 11 and Figure 13 As shown, the release knob 62 has a connecting tooth 621, and the inner connecting sleeve 51 has a first external thread 510 (e.g., 6 turns). The connecting tooth 621 can be inserted into the first external thread 510 by moving along it. In the first locked state or the second locked state, the connecting tooth 621 is located at the front end of the first external thread 510 or between its two ends; in the released state, the connecting tooth 621 is located at the rear end of the first external thread 510. Rotating the release knob 62 counterclockwise will cause it to retract 6 turns and stop. At the same time, the release knob 62 will drive the inner tube connecting seat 52 to rotate counterclockwise 6 turns. The inner connecting sleeve 51 and the release knob 62 are restricted from rotation by the pin 61 before the pin 61 is removed. In some other embodiments, the release knob 62 has an internal thread, and the inner connecting sleeve 51 has a connecting tooth that can be inserted into the external thread by moving along it.

[0055] Furthermore, the front of the inner connecting sleeve 51 is provided with an internal thread 511 (e.g., 2 turns), and the rear end of the stroke seat 3 is provided with a matching second external thread 30 (e.g., 2 turns). When the interlocking release mechanism 6 is in the first locked state or the second locked state, the internal thread 511 and the second external thread 30 are connected; when the interlocking release mechanism 6 is in the released state, the internal thread 511 and the second external thread 30 are disengaged. The inner connecting sleeve 51 is connected to the tail of the stroke seat 3 by 2 turns of thread. It can be dropped and moved backward by rotating counterclockwise 2 turns. However, before rotation, the middle tube connecting seat 4 needs to be pushed forward out of the inner connecting sleeve 51 before it can be rotated. Specifically, it is pushed out of the inner connecting sleeve 51 by the following springback operation.

[0056] Further, the interlocking disengaging mechanism 6 pushes the interlocking push rod 63 to the second position by moving the middle tube connecting seat 4 backward during the switching process from the first locking state to the second locking state, and the middle tube connecting seat 4 then rebounds to disengage the connecting portion 41 from the connecting groove 512 of the inner connecting sleeve 51. Specifically, the operation handle 100 further comprises a first threaded tube 42 rotatably arranged in the housing 1 about the center line C and a first operation knob 43 for driving the first threaded tube 42 to rotate. The first operation knob 43 is rotatably arranged on the housing 1, and the rotation axis of the first operation knob 43 intersects the center line C, and in this embodiment, the intersection is perpendicular. The first threaded tube 42 has a third external thread 420, which has a last first thread 420a and a second thread 420b adjacent to the first thread 420a, and the first thread 420a and the second thread 420b are connected by a rebound groove 421, and the pitch between the first thread 420a and the second thread 420b gradually increases in the direction from front to back. The middle tube connecting seat 4 has a connecting lug 44 which is movably inserted into the third external thread 420 along the third external thread 420 and the rebound groove 421. The middle tube connecting seat 4 is driven to rebound by the pulling force of the middle tube 202 to release the stress of the middle tube 202 during the locking process. That is, the third external thread 420 is a double spiral with variable diameter, the pitch becomes larger as it approaches the rear end, and at the end of the last first thread 420a, there is a rebound groove 421 that directly connects the second-to-last thread 420b. The travel seat 3 and the third knob external thread tube are connected to each other through the two connecting lugs 44 on both sides of the middle tube connecting seat 4. Since the middle tube connecting seat 4 will be pulled to the left after moving backward to a certain extent, it will fall into the second-to-last thread (i.e., the second thread 420b) after reaching the end of the third external thread 420.

[0057] The operation handle 100 further comprises a second threaded tube 31 rotatably arranged in the housing 1 about the center line C and a second operation knob 32 for driving the second threaded tube 31 to rotate. The second threaded tube 31 is threadedly connected with the travel seat 3, and the second operation knob 32 is rotatably arranged on the housing 1, and the rotation axis of the second operation knob 32 intersects the center line C, and in this embodiment, the intersection is perpendicular.

[0058] The outer tube connecting seat 2 is movably arranged in the housing 1 along the center line C, and the operating handle 100 further comprises a third threaded tube 21 rotatably arranged in the housing 1 around the center line C and a third operating knob 22 for driving the third threaded tube 21 to rotate. The third threaded tube 21 is threadedly connected with the outer tube 201 fixing seat, and the third operating knob 22 is rotatably arranged on the housing 1, and the rotation axis of the third operating knob 22 intersects with the center line C, and in the embodiment, the rotation axis of the third operating knob 22 is perpendicular to the center line C. The operating handle 100 further comprises an operating lever 23 for operating the pull wire 204 to open or close the rear clip assembly 302 of the implant 300. Specifically, when the pull wire 204 is pulled backward, the rear clip assembly 302 is closed, and when the pull wire 204 is released, the rear clip assembly 302 is automatically opened.

[0059] Referring to Figures 1 to 4 As shown in the figure, the second operating knob 32 is located at the front side of the stroke seat 3, and the third operating knob 22 is located at the rear side of the outer tube 201 fixing seat. The rear part of the outer tube connecting seat 2 is connected with a rear clip assembly position indicating rod 24, the front part of the stroke seat 3 is connected with a front clip assembly position indicating rod 33, and the housing 1 is provided with an observation window 11 for observing the relative positions of the rear clip assembly position indicating rod 24 and the front clip assembly position indicating rod 33, and the observation window 11 is located between the outer tube connecting seat 2 and the stroke seat 3. Referring to Figure 1As shown, the first operation knob 43, the second operation knob 32 and the third operation knob 22 are arranged in pairs on the left and right sides of the housing 1, and are spaced from back to front, and the observation window 11 is located between the second operation knob 32 and the third operation knob 22; the dissociation knob 62 is located on the rear end of the entire operation handle 100, and is coaxially arranged with the housing 1. The third operation knob 22 and the third threaded tube 21 are driven by bevel gear or friction transmission, and rotating the third operation knob 22 can drive the outer tube connecting seat 2 to move forward and backward, and the outer tube 201 drives the rear clamp assembly 302 to translate; the second operation knob 32 and the second threaded tube 31 are driven by bevel gear or friction transmission, and rotating the second operation knob 32 can drive the stroke seat 3 to move forward and backward, and the middle tube 202 and the inner tube 203 synchronously move to drive the front clamp assembly 301 to translate as a whole (wherein the middle tube 202 and the first base point of the front clamp assembly 301 are connected, the inner tube 203 and the second base point of the front clamp assembly 301 are connected, and the first base point and the second base point can move synchronously or relatively); the first operation knob 43 and the first threaded tube 42 are driven by bevel gear or friction transmission, and rotating the first operation knob 43 can drive the middle tube connecting seat 4 to move forward and backward, and the outer tube 201 drives the front clamp assembly 301 to open or close (the first base point approaches or moves away from the second base point); rotating the dissociation knob 62 can make the inner tube rotate, and release the threaded connection with the implant 300, and release the implant 300. The dissociation knob 62 is connected with the stroke seat 3 when the implant part is operated, and does not need to be moved or rotated; and is rotated when the dissociation step is performed. Since the implant 300 needs to be rotated counterclockwise for 6 turns before being locked; and is rotated counterclockwise to be released when the front clamp assembly 301 is released. Therefore, the dissociation knob 62 is provided with two gears, the first gear is rotated for 6 turns, and the second gear is rotated infinitely. The safety bolt 61 is placed on the dissociation knob 62, and is used to prevent the doctor from misoperating the release part before the implant 300 reaches the expected target point; and the safety bolt 61 can block the middle tube 202 operated by the first operation knob 43, and prevent the doctor from locking before reaching the target position.

[0060] After confirming the front and rear clip assemblies 301, 302 of the implant 300 are closed, the logical sequence of actions to be performed is: the inner tube 203 is rotated counterclockwise for 6 turns; the middle tube 202 is retracted by 6 mm, and then is retracted to release the tension; the inner tube 203 is continuously rotated counterclockwise until disengagement. The corresponding operations of the operating handle 100 are: after confirming the front and rear clip assemblies 301, 302 of the implant 300 are closed, the pin 61 is removed, and before performing the next action, the middle tube connecting seat 4 cannot be continuously retracted due to the limit of the interlocking push rod 63; the disengagement knob 62 is rotated counterclockwise, which drives the inner tube connecting seat to rotate counterclockwise for 6 turns, but does not move forward and backward, and this operation drives the inner tube to rotate counterclockwise for 6 turns; the first operation knob 43 is rotated to retract the middle tube connecting seat 4 to the end; after being retracted to the end, the middle tube connecting seat 4 automatically rebounds to release the tension due to the tension of the middle tube 202, before this step, the disengagement knob 62 cannot be rotated because the rear end of the middle tube connecting seat 4 is in the inner connecting sleeve 51, this step makes the middle tube 202 retract by 6 mm and then is retracted to release the tension; the disengagement knob 62 is rotated clockwise to disengage, and because the middle tube connecting seat 4 exits the inner connecting sleeve 51, the disengagement knob 62 can drive the inner connecting sleeve 51 to rotate. After the inner connecting sleeve 51 rotates for two turns, it is peeled off from the stroke seat 3, and can be infinitely rotated until disengagement.

[0061] The embodiment also provides an operating method of the operating handle 100 of the heart implant 300, which is the operating handle 100 described above, and is used for non-diagnostic and therapeutic purposes. The operating method comprises the following steps:

[0062] After the front and rear clip assemblies 301, 302 of the implant 300 are combined, the middle tube connecting seat 4 is moved backward by a first stroke until it is blocked by the first locking member, so as to close the front clip assembly 301 to the minimum;

[0063] The first locking member is removed, and the middle tube connecting seat 4 is continuously moved backward by a second stroke, so as to further move the front clip assembly 301 backward to be locked with the rear clip assembly 302;

[0064] The inner tube connecting assembly 5 is moved backward to release the implant 300.

[0065] Further, after the pin 61 is removed, the following steps are performed first:

[0066] The disengagement knob 62 is rotated in the first direction, and the disengagement knob 62 moves backward to leave space for the interlocking push rod 63 on the rear side of the middle tube connecting seat 4;

[0067] Then, the first operation knob 43 is rotated to move the middle tube connecting seat 4 backward by the second stroke.

[0068] Further, after the middle tube connecting seat 4 is moved backward by the second stroke and rebounds to the first stroke, the connecting part 41 of the middle tube connecting seat 4 exits the inner tube connecting assembly 5.

[0069] Further, the step of moving the inner tube connecting assembly 5 rearward specifically comprises:

[0070] After the middle tube connecting seat 4 and the inner tube connecting assembly 5 are separated, the disengaging knob 62 is rotated in the first direction, so that the inner tube connecting assembly 5 is released, allowing the inner tube 203 and the implant 300 to be separated and withdrawn.

[0071] The operation method is specifically implemented as follows:

[0072] S1, the front clamp assembly 301 is opened by rotating the first operation knob 43, the rear clamp assembly 302 is opened by operating the operating rod 23, and the front clamp assembly 301 and the rear clamp assembly 302 are combined by rotating the second operation knob 32 and the third operation knob 22 to control the movement of the stroke seat 3 and the outer tube connecting seat 2;

[0073] S2, the middle tube connecting seat 4 is moved rearward by a first stroke by rotating the first operation knob 43 until it is blocked by the plug 61, so as to close the front clamp assembly 301 to the minimum;

[0074] S3, the plug 61 is removed;

[0075] S4, the disengaging knob 62 is rotated in the first direction, so that the disengaging knob 62 moves rearward relative to the inner tube connecting assembly 5, and space is left for the interlocking push rod 63 on the rear side of the middle tube connecting seat 4;

[0076] S5, the first operation knob 43 is operated, the middle tube connecting seat 4 continues to move rearward by a second stroke, so that the front clamp assembly 301 further moves rearward to be locked with the rear clamp assembly 302; then, the middle tube connecting seat 4 rebounds forward under the pulling force of the middle tube 202, so as to exit the inner tube connecting assembly 5, thereby allowing the inner tube connecting assembly 5 to rotate;

[0077] S6, the disengaging knob 62 is continuously rotated in the first direction, so that the disengaging knob 62 and the stroke seat 3 are separated, and the inner tube connecting assembly 5 is rotated to release the implant 300.

[0078] The operation process of the operation handle 100 is generally as follows:

[0079] 1, when the delivery sheath tube 200 sends the implant 300 to the target point that needs to be operated, the first operation knob 43 is rotated to move the middle tube 202 forward to open the front clamp assembly 301 of the implant 300.

[0080] 2, the second operation knob 32 is rotated to move the middle tube 202 and the inner tube 203 forward at the same time, and the front clamp assembly of the implant 300 will be translated forward as a whole.

[0081] 3, the operating rods 23 on both sides are pushed downward, which will make the rear clamp assembly 302 of the implant 300 open;

[0082] 4. Rotate the third operation knob 22 to move the outer tube 201 forward, and observe the observation window 11, the upper clamp assembly is combined.

[0083] 5. Rotate the first operation knob 43 to move the middle tube 202 backward to the position of the plug 61, and due to the blocking of the plug 61, it cannot continue to move backward, and this operation will close the upper clamp assembly to the minimum.

[0084] At this time, the dissociation process begins, and there is interlocking logic:

[0085] 6. In the operation of the previous step, when the middle tube connecting seat 4 retreats backward, it will block the second gear of the dissociation knob 62, so that it cannot rotate infinitely (the connecting part 41 is inserted into the inner connecting sleeve 51). At this time, remove the plug 61, and rotate the dissociation knob 62 counterclockwise for 6 turns to make the implant 300 enter the locked state.

[0086] Due to the removal of the plug 61, the rotation of the dissociation knob 62 for 6 turns will leave a position, and at this position, the first operation knob 43 can be operated to continue to retreat until the implant 300 is locked. After the implant 300 is locked, due to the variable diameter and springback design of the third outer thread 420, the middle tube 202 and the middle tube connecting seat 4 will spring back and withdraw from the inner connecting sleeve 51, and the second gear of the dissociation knob 62 will be opened.

[0087] 7. Rotate the fourth knob counterclockwise until it can be pulled out, which represents the release of the implant 300.

[0088] The operation sequence of the embodiment is as follows: after the operation handle 100 of the implant 300 is operated and it is confirmed that the implant 300 is closed to the minimum, the plug 61 is removed, the dissociation knob 62 is rotated for 6 turns (the first operation knob 43 can continue to rotate backward after the dissociation knob 62 is rotated for 6 turns), the first operation knob 43 is rotated backward to lock the upper clamp assembly 301 and the lower clamp assembly 302 (the dissociation knob 62 can rotate counterclockwise infinitely after the upper clamp assembly 301 and the lower clamp assembly 302 are locked), and the dissociation knob 62 is rotated infinitely to release.

[0089] It should be noted that, unless otherwise specified, when a certain feature is referred to as being "fixed" or "connected" to another feature, it can be directly fixed or connected to the other feature, or indirectly fixed or connected to the other feature. In addition, the up, down, left, right and other descriptions used in the present application are only relative to the relative positions of the components of the present application in the drawings, and can be referred to the drawings Figure 2 .

[0090] .It should be further understood that "a plurality" or "a plurality of something" refers to two or more of that thing, and not to one of that thing. Similarly, "a number" or "a number of something" refers to one or more of that thing. Also, "plurality" or "a plurality" of something can refer to two or more of that thing, and not to one of that thing. Similarly, "a number" or "a number of something" refers to one or more of that thing. It should be further understood that the terms "comprises", "comprising", "includes", "including", "has", "having", "contains", "containing", or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises, includes, has, contains a list of elements does not include only those elements but can include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by "comprises a", "has a", "includes a", or "contains a", does not, without more constraints, preclude the existence of additional identical elements. Other identities can be present.

[0091] It should be further understood that the terms "first", "second", etc. are used to describe various information, but these information should not be limited to these terms. These terms are only used to distinguish the same type of information from each other, and do not represent a specific order or importance. In fact, the expressions "first", "second", etc. can be used interchangeably. For example, the first information can also be referred to as the second information, and similarly, the second information can also be referred to as the first information without departing from the scope of the present disclosure.

[0092] The above examples are only for illustrating the technical concept and characteristics of the present application, and are a preferred embodiment, the purpose of which is to enable those skilled in the art to understand the content of the present application and implement it, and cannot limit the protection scope of the present application. Any equivalent transformation or modification made according to the principle of the present application should be covered within the protection scope of the present application.

Claims

1. An interlock disengagement mechanism for an operating handle of a cardiac implant implantation instrument, the operating handle for manipulating a delivery sheath to cause the implant to grip cardiac tissue, the operating handle comprising a housing and a mid tube connection seat and an inner tube connection assembly for connection to a mid tube and an inner tube, respectively, of the delivery sheath, characterized in that, The interlocking dissociation mechanism is arranged between the middle tube connecting seat and the inner tube connecting assembly, the middle tube connecting seat has a connecting part, the inner tube connecting assembly includes an inner connecting sleeve and an inner tube connecting seat, the rear end of the inner connecting sleeve is fixedly connected with the inner tube connecting seat, the inner tube is fixed on the inner tube connecting seat, and the inner connecting sleeve has a connecting groove matched with the connecting part; the interlocking dissociation mechanism has a locking state and a dissociation state, in the locking state, the connecting part is inserted into the connecting groove to prevent the inner connecting sleeve from moving relative to the middle tube connecting seat, and in the dissociation state, the connecting part is separated from the connecting groove to allow the inner tube connecting seat to move backward relative to the middle tube connecting seat. The interlocking dissociation mechanism includes an outer operating sleeve, the outer operating sleeve is sleeved on the inner connecting sleeve, and the inner tube connecting seat is movably arranged in the outer operating sleeve along a center line; in the dissociation state, the outer operating sleeve is configured to move backward relative to the inner connecting sleeve. The outer operating sleeve is rotatably sleeved on the inner connecting sleeve, the outer operating sleeve is provided with a connecting tooth, the inner connecting sleeve is provided with a first external thread, and the connecting tooth is movably inserted into the first external thread along the first external thread. The locking state includes a first locking state and a second locking state, the interlocking dissociation mechanism further includes a second locking member, the second locking member is located between the connecting part and the outer operating sleeve and has a first position and a second position located a distance behind the first position, in the first locking state, the second locking member is located at the first position, the front end of the second locking member abuts against the connecting part, and the rear end abuts against the outer operating sleeve. In the switching process from the first locking state to the second locking state, the outer operating sleeve moves backward relative to the inner connecting sleeve to allow the second locking member to move backward. When the interlocking dissociation mechanism is in the dissociation state, the second locking member is located at the second position.

2. The interlock dissociation mechanism of claim 1, wherein, In the locking state, the connecting tooth is located at the front end of the first external thread or between the two ends of the first external thread, in the dissociation state, the connecting tooth is located at the rear end of the first external thread, or the outer operating sleeve is provided with an internal thread, the inner connecting sleeve is provided with a connecting tooth, and the connecting tooth is movably inserted into the external thread along the external thread.

3. The interlock dissociation mechanism of claim 1, wherein, The second locking member is an interlocking push rod, the interlocking push rod is located in the inner connecting sleeve, the rear end of the interlocking push rod penetrates through the inner connecting sleeve and can abut against the rear end of the outer operating sleeve.

4. The interlock dissociation mechanism of claim 1, wherein, The operating handle further comprises a stroke seat movably connected to the shell along the center line, and the middle tube connecting seat is movably arranged on the stroke seat along the center line; the front part of the inner connecting sleeve is provided with an inner thread, and the rear end part of the stroke seat is provided with a second outer thread matched with the inner thread; when the interlocking disengaging mechanism is in the locked state, the inner thread and the second outer thread are connected; when the interlocking disengaging mechanism is in the disengaged state, the inner thread and the second outer thread are disengaged.

5. A handle for a cardiac implant implantation instrument for manipulating a delivery sheath to grip cardiac tissue with an implant, the handle comprising a housing and outer tube, middle tube and inner tube connection assemblies for connection to an outer tube, middle tube and inner tube, respectively, of the delivery sheath, the housing having a centerline extending along a length of the delivery sheath; wherein, The operating handle further comprises the interlocking disengaging mechanism according to any one of claims 1 to 4.

6. Handle for operating a cardiac implant implantation instrument according to claim 5, characterized in that The operating handle further comprises a stroke seat movably connected to the shell along the center line, and the middle tube connecting seat is movably arranged on the stroke seat along the center line; the front part of the inner connecting sleeve is provided with an inner thread, and the rear end part of the stroke seat is provided with a second outer thread matched with the inner thread; when the interlocking disengaging mechanism is in the locked state, the inner thread and the second outer thread are connected; when the interlocking disengaging mechanism is in the disengaged state, the inner thread and the second outer thread are disengaged.

7. Handle for operating a cardiac implant implantation instrument according to claim 6, characterized in that The interlocking disengaging mechanism comprises an outer operating sleeve sleeved on the inner connecting sleeve; the locked state comprises a first locked state and a second locked state, and the interlocking disengaging mechanism further comprises a second locking member located between the connecting part and the outer operating sleeve and having a first position and a second position located a distance behind the first position; when the interlocking disengaging mechanism is in the first locked state, the second locking member is located at the first position, and the front end part of the second locking member abuts against the connecting part, and the rear end part abuts against the outer operating sleeve; During the switching process from the first locked state to the second locked state, the outer operating sleeve moves backward relative to the inner connecting sleeve to push the second locking member to the second position, and the middle tube connecting seat is then rebounded to disengage the connecting part from the inner connecting sleeve; when the interlocking disengaging mechanism is in the disengaged state, the second locking member is located at the second position.

8. Handle for operating a cardiac implant implantation instrument according to claim 7, characterized in that The operating handle further comprises a first threaded tube rotatably arranged in the shell around the center line, and a first operating knob for driving the first threaded tube to rotate, the first operating knob is rotatably arranged on the shell, the rotation axis of the first operating knob intersects with the center line, the first threaded tube has a third outer thread, the third outer thread has a first thread ring at the last side and a second thread ring adjacent to the first thread ring, and the first thread ring and the second thread ring have a rebound groove connecting the two; the middle tube connecting seat has a connecting lug movably inserted into the third outer thread along the third outer thread and the rebound groove.

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