CN211934430U

CN211934430U - Chordae tendineae regulating implant, chordae tendineae regulating device and chordae tendineae regulating system

Info

Publication number: CN211934430U
Application number: CN201922502010.6U
Authority: CN
Inventors: 蒋权杰; 郭荣辉; 黄桥; 谢琦宗
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2019-12-31
Filing date: 2019-12-31
Publication date: 2020-11-17
Anticipated expiration: 2029-12-31

Abstract

The utility model provides a simple structure, simple operation's chordae tendineae regulation and control implant, chordae tendineae regulation and control device and chordae tendineae regulation and control system, chordae tendineae regulation and control implant includes: the wire locking sleeve is provided with a wire locking groove on the wall, and the wire locking groove extends along the circumferential direction of the wire locking sleeve; the cylinder wall of the locking wire sleeve is provided with at least two rows of a plurality of gear grooves which are arranged along the axial direction; the locking elastic sheet is arranged in the inner cavity of the locking wire sleeve and comprises a bearing table and at least two side wings; when the locking wire groove of the locking wire sleeve hooks the artificial chordae tendineae, at least two side wings are in a folded state, and the bearing platform pushes the artificial chordae tendineae to move along the axial direction of the locking wire sleeve under the external force, so that the effective length of the artificial chordae tendineae is reduced; when the effective length of the artificial chordae tendineae is reduced to the target length, at least two side wings are unfolded to be respectively clamped in at least two rows of gear grooves, so that part of the artificial chordae tendineae is folded and limited between the locking wire sleeve and the bearing table.

Description

Chordae tendineae regulating implant, chordae tendineae regulating device and chordae tendineae regulating system

Technical Field

The utility model relates to the technical field of medical equipment, especially, relate to a chordae tendineae regulation and control implant, chordae tendineae regulation and control device and chordae tendineae regulation and control system.

Background

The mitral valve is a one-way "valve" between the left atrium and the left ventricle that ensures blood flow from the left atrium to the left ventricle. A normal healthy mitral valve has a plurality of chordae tendineae. The valve leaves of the mitral valve are divided into an anterior leaf and a posterior leaf, when the left ventricle is in a diastole state, the two are in an opening state, and blood flows from the left atrium to the left ventricle; when the left ventricle is in a contraction state, the chordae tendineae are stretched to ensure that the valve leaflets cannot be flushed to the atrium side by blood flow, and the front and rear leaflets are closed well, so that blood is ensured to flow from the left ventricle to the aorta through the aortic valve. If the chordae tendineae are diseased, such as ruptured, the mitral valve will not return to a closed state as it would in a normal state when the left ventricle is in a contracted state, and the momentum of the blood flow will further cause the leaflets to fall into the left atrium, causing blood backflow.

The surgery is an effective treatment method for mitral regurgitation, but the trauma to human body is large, and the minimally invasive intervention treatment methods include artificial chordae implantation, mitral valve annuloplasty, mitral valve edge-to-edge repair, and the like, wherein the implantation of the artificial chordae on the valve leaflets can effectively treat mitral insufficiency and regurgitation caused by chordae rupture, leaflet prolapse, and the like. The principle of the implantation mode of the artificial chordae tendineae is that one side of the artificial chordae tendineae is fixed on the valve leaflets, the other side of the artificial chordae tendineae is fixed on papillary muscles or myocardial walls, and the artificial chordae tendineae replace the native chordae tendineae to pull the mitral valve leaflets to be restored to the normal opening and closing state so as to achieve the purpose of treating mitral regurgitation.

Before the artificial chordae tendineae are implanted, the left ventricle has limited blood pumping capacity to the aorta due to mitral insufficiency, the pressure is increased, and the left ventricle is easy to be in an expansion state under the long-term disease state. Statistically, the left ventricular end diastolic diameters (LVDd) and the left ventricular end systolic diameters (LVDs) of the patients with severe MR are respectively higher by about 11mm and 8mm on average compared with normal persons, and are respectively higher by about 2mm and 3.5mm on average compared with the patients with mild MR. After the artificial chordae are implanted, the patients with severe MR turn to mild MR or the regurgitation completely disappears, at this time, the volume of the left ventricle gradually shrinks to a normal level, and the previously implanted artificial chordae gradually relaxes from a tightened state, and the length is relatively longer, so that the pulling effect on the valve leaflets is correspondingly weakened or disappears, and the mitral valve leaflets re-prolapse and the risk of incomplete closure are caused, and then the mitral valve regurgitation condition occurs again. Therefore, after the artificial chordae are implanted for a certain period of time, the length of the implanted artificial chordae needs to be adjusted.

SUMMERY OF THE UTILITY MODEL

The utility model provides a simple structure, simple operation's chordae tendineae regulation and control implant, chordae tendineae regulation and control device and chordae tendineae regulation and control system.

In a first aspect, the present invention provides a tendon control implant for adjusting the effective length of an artificial tendon, comprising:

the wire locking sleeve is provided with a wire locking groove communicated with the inner cavity of the wire locking sleeve on the wall, and the wire locking groove extends along the circumferential direction of the wire locking sleeve; the cylinder wall of the locking wire sleeve is provided with at least two rows of a plurality of gear grooves which are arranged along the axial direction; and

the locking elastic sheet is arranged in the inner cavity of the locking wire sleeve and comprises a bearing table and at least two side wings, and the at least two side wings extend from the bearing table to the sides of the at least two rows of gear grooves respectively;

when the locking wire groove of the locking wire sleeve hooks the artificial chordae tendineae, the at least two side wings are in a folded state, and the bearing platform pushes the artificial chordae tendineae to move along the axial direction of the locking wire sleeve under external force so as to reduce the effective length of the artificial chordae tendineae; when the effective length of the artificial chordae tendineae is reduced to the target length, the at least two side wings are unfolded to be respectively clamped in the at least two rows of the gear grooves, so that part of the artificial chordae tendineae is folded and limited between the locking line sleeve and the bearing table.

In a second aspect, the present invention provides a tendon control device, including a tendon control implant and a conveyor, the conveyor including:

the connecting piece is connected with the distal end of the catheter and is used for connecting a locking wire sleeve of the chordae tendineae regulating implant;

a control handle connected to the proximal end of the catheter; and

the propelling movement subassembly, the propelling movement subassembly is located the inner chamber of connecting piece, the inner chamber of pipe reaches in the accommodating space that the inner chamber of regulation and control handle formed, the near-end of propelling movement subassembly is connected the regulation and control handle, the distal end of propelling movement subassembly makes two at least flanks of the locking shell fragment of chordae tendineae regulation and control implant are in folded state or open state, the propelling movement subassembly receives controlling of regulation and control handle promotes the locking shell fragment of chordae tendineae regulation and control implant is along axial displacement, and makes the connecting piece with chordae tendineae regulation and control implant separation.

A third aspect, the utility model provides a pair of chordae tendineae regulation and control system, reach including adjustable curved sheath chordae tendineae regulation and control device, adjustable curved sheath includes the sheath pipe and connects the curved brake valve lever of accent of the near-end of sheath pipe, it is used for control to transfer curved brake valve lever the sheath pipe is crooked, chordae tendineae regulation and control implant the connecting piece reaches the pipe activity is worn to locate the inner chamber of sheath pipe with in the inner chamber of transferring curved brake valve lever.

The utility model provides a tendon regulating implant, which comprises a locking line sleeve and a locking elastic sheet, wherein the locking line sleeve is used for hooking artificial tendons, and the locking elastic sheet gradually brings the artificial tendons into the locking line sleeve in the process of gradually entering the locking line sleeve so as to reduce the effective length of the artificial tendons; when the effective length of the artificial chordae tendineae is reduced to a proper length, at least two side wings of the locking elastic sheet are opened and clamped in the gear groove of the locking wire sleeve, so that part of the artificial chordae tendineae is folded and limited between the locking wire sleeve and the bearing table, and the part of the artificial chordae tendineae is folded into a shape like a Chinese character 'ji' or an inverted 'U' shape, so that the effective length of the artificial chordae tendineae can be fixed after being reduced, and the chordae tendineae regulating and controlling implant realizes the effect of regulating the effective length of the artificial chordae tendineae. The tendon regulation implant provided by the utility model has the characteristics of simple structure, simple and convenient regulation and control operation, reliable regulation and control effect and the like.

The tendon regulation and control device and the tendon regulation and control system provided by the utility model comprise the tendon regulation and control implant and the conveyor, the pushing component of the conveyor can enable at least two side wings of the locking elastic sheet of the tendon regulation and control implant to be in a furled state under the action of the regulation and control handle and push the locking elastic sheet in the furled state to move along the axial direction of the locking sleeve, so that part of the artificial chordae tendineae is folded and trapped between the locking wire sleeve and the carrier, thereby reducing the effective length of the artificial chordae tendineae, when the effective length of the artificial chordae tendineae is reduced to a proper length, the pushing component of the conveyor releases at least two side wings of the locking shrapnel, so that at least two side wings of the locking elastic sheet are opened and clamped in the gear groove of the locking wire sleeve, so that the locking elastic sheet is fixed on the locking wire sleeve, and the effective length of the artificial chordae tendineae is not reduced and is fixed; a pushing assembly of the transporter separates the connector from the chordae modulating implant to secure the chordae modulating implant to the artificial chordae. Thus, the tendon control device and the tendon control system realize the adjustment of the effective length of the artificial tendon, and fix the tendon control implant on the artificial tendon. The utility model provides a chordae tendineae regulation and control device and chordae tendineae regulation and control system have simple structure, regulation and control easy and simple to handle, characteristics such as the regulation and control effect is reliable.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art that other drawings can be obtained according to these drawings without creative efforts.

Fig. 1 is a schematic structural diagram of a tendon regulating system according to an embodiment of the present invention;

fig. 2 is a schematic structural view of an adjustable curved sheath in a straightened state according to an embodiment of the present invention;

fig. 3 is a schematic structural diagram of a tendon regulating device according to an embodiment of the present invention;

figure 4 is a schematic view of a chordae modulating implant provided in accordance with an embodiment of the present invention after implantation;

fig. 5a is a schematic view of a tendon control implant according to an embodiment of the present invention controlling artificial chordae at a viewing angle;

fig. 5b is a schematic view of a tendon control implant according to an embodiment of the present invention controlling artificial chordae at another viewing angle;

fig. 6 is a schematic perspective view of a locking sleeve in an implant for controlling chordae tendineae according to an embodiment of the present invention;

fig. 7 is a schematic perspective view of a locking spring in an implant for controlling tendon cables according to an embodiment of the present invention in a closed state;

fig. 8 is a schematic perspective view of an open locking spring in an implant for controlling tendon cables according to an embodiment of the present invention;

fig. 9a is a schematic structural view illustrating the artificial chordae tendineae hooked by the chordae tendineae regulating implant according to an embodiment of the present invention;

FIG. 9b is a schematic cross-sectional view of FIG. 9 a;

fig. 10a is a schematic structural view illustrating the locking elastic piece axially moving forward and bending the artificial chordae tendineae according to the embodiment of the present invention;

FIG. 10b is a schematic cross-sectional view of FIG. 10 a;

fig. 11a is a schematic structural view illustrating a locking elastic piece engaged with the locking wire sleeve and locking the effective length of the artificial chordae tendineae according to an embodiment of the present invention;

FIG. 11b is a schematic cross-sectional view of FIG. 11 a;

figure 12a is a schematic view of a tendon control implant according to an embodiment of the present invention secured to an artificial tendon;

FIG. 12b is a schematic cross-sectional view of FIG. 12 a;

fig. 13 is a schematic far-end exploded perspective view of a tendon control device according to an embodiment of the present invention;

fig. 14 is an exploded view of the proximal end of a tendon control device according to an embodiment of the present invention;

fig. 15 is a schematic structural view of a handle in the tendon control device according to an embodiment of the present invention;

fig. 16 is a schematic structural view of a push tube in the tendon control device according to an embodiment of the present invention;

fig. 17 is a schematic structural view of an adjustable sheath in a tendon control device according to an embodiment of the present invention in a bending state;

fig. 18 is a schematic partial sectional view of a bending control handle of an adjustable bending sheath according to an embodiment of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. The embodiments of the present invention can be combined with each other appropriately.

For convenience of description, the end of all structures farther from the operator is defined as the far end of the structure, and the end of all structures closer to the operator is defined as the near end of the structure.

Referring to fig. 1 to 4, the present invention provides a tendon regulating system 100, which includes an adjustable sheath 20 and a tendon regulating device 30. The chordae regulating device 30 includes a chordae regulating implant 10 and a delivery device 40.

As shown in fig. 4, the tendon control implant 10 is implanted into a ventricle to fold a portion of the artificial tendon 200 in an inverted "U" shape or "several" shape in the tendon control implant 10 to shorten the effective length of the artificial tendon 200, and the effective length of the artificial tendon 200 is adjusted by adjusting the folded length of the artificial tendon 200 in the tendon control implant 10. An effective length of suitable artificial chordae 200 should be the length required for the artificial chordae to be able to pull the leaflets so that they close normally.

Referring to fig. 2, the adjustable bending sheath 20 includes a sheath 21 and a bending control handle 22. The sheath 21 is mounted to the distal end of the bend adjustment control handle 22. The adjustable curved sheath 20 is used to provide a conduction path from the outside world into the ventricle. Referring to fig. 1, the delivery device 40 delivers the chordae modulating implant 10 to the artificial chordae 200 via a conductive path created by the adjustable sheath 20.

Referring to fig. 3, delivery device 40 includes a catheter 41, a control handle 42, a connector 43 (see fig. 13), and a pusher assembly 44 (see fig. 14). The catheter 41 is mounted to the distal end of a control handle 42. The connector 43 is connected to the distal end of the catheter 41. Chordae regulating implant 10 is removably attached to the distal end of attachment member 43. The pushing assembly 44 is disposed through the connecting member 43, the guiding tube 41 and the control handle 42.

The conveyor 40 is used to convey the chordae modulating implant 10 and the active chordae modulating implant 10 to adjust the folded length of the artificial chordae 200 within the chordae modulating implant 10 so that the chordae modulating implant 10 adjusts the effective length of the artificial chordae 200 to the proper size.

Referring to fig. 1-3, the catheter 41 of the delivery device 40 is movably inserted into the sheath 21 and the bending control handle 22, and extends out of the distal end of the sheath 21. The distal end of the sheath 21 can be bent and can rotate correspondingly with the twisting of the bending control handle 22. The catheter 41 is coaxial with the sheath 21 and can rotate in the sheath 21 to control the opening orientation of the locking wire groove 111 on the tendon regulating implant 10 for hooking the artificial tendon 200, so as to facilitate hooking the artificial tendon 200 by the locking wire groove 111.

In one scenario, referring to fig. 1-4, the sheath 21 is advanced through the femoral artery, over the aortic arch and into the left ventricle to provide access for the delivery device 40. After the catheter 41 of the delivery device 40 has passed through the sheath 21 to the left ventricle, the chordae regulating implant 10, which is disposed distally of the catheter 41 of the delivery device 40, extends distally of the sheath 21. The artificial chordae tendineae 200 can be hooked by the chordae regulation implant 10 accurately by adjusting the bending angle and twisting the direction of the distal end of the sheath 21. The therapeutic effect of mitral regurgitation is observed according to the ultrasound image and the DSA image, and the artificial chordae tendineae 200 are contracted and controlled by appropriately adjusting the chordae tendineae control implant 10. After adjusting the effective length of the artificial chordae 200 to the length required for the artificial chordae to pull the leaflets closed properly, the chordae modulating implant 10 is released from the carrier 40 by controlling the modulation handle 42 at the proximal end of the carrier 40. The chordae modulating implant 10 is secured to the artificial chordae 200 such that the artificial chordae 200 is shortened in length and remains in the left ventricle as part of the artificial chordae 200. Finally, the catheter 41 of the delivery device 40 and the sheath 21 are withdrawn, and the contraction control of the artificial chordae tendineae 200 is completed.

The embodiments of the present invention will be described with reference to the accompanying drawings, which illustrate the specific structure of the chordae regulating implant 10. For convenience of description, the axial direction of the chordae modulating implant 10 is defined as the Y-axis direction, the distal direction is the Y-axis forward direction, and the proximal direction is the Y-axis reverse direction.

Referring to fig. 5a and 5b, the tendon-regulating implant 10 includes a locking wire sleeve 11 and a locking spring 12 capable of being engaged with the locking wire sleeve 11.

Referring to fig. 6, the wire locking sleeve 11 has a hollow inner cavity 110. The cylinder wall of the locking wire sleeve 11 is provided with a locking wire groove 111 communicated with the inner cavity of the locking wire sleeve 11. In other words, the cylinder wall of the locking wire sleeve 11 is provided with a locking wire groove 111 penetrating at least a part of the cylinder wall along the circumferential direction.

Specifically, the wire sleeve 11 is generally made of a rigid material with biocompatibility, such as SUS316L stainless steel or PP material. The wire locking sleeve 11 has an external shape including, but not limited to, a cylinder, and may have an oval or square cylindrical structure. Specifically, the locking wire groove 111 is formed in the middle of the locking wire sleeve 11 and has an arc-shaped opening groove. The artificial chordae tendineae 200 may be hooked into the locking wire sleeve 11 to facilitate subsequent manipulation of the artificial chordae tendineae 200. The locking line groove 111 is formed in the cylinder wall along the circumferential direction. Visualization under ultrasound is easy, both laterally and axially, and the artificial chordae tendineae 200 are easily hooked.

Referring to fig. 6, the locking wire groove 111 extends along the circumferential direction of the locking wire sleeve 11. Specifically, the intersecting surface of the locking wire groove 111 and the cylinder wall of the locking wire sleeve 11 may be perpendicular or inclined with respect to the axis of the locking wire sleeve 11. In other words, the surface of the wire locking groove 111 extending in the direction perpendicular to the axial direction of the wire locking sleeve 11; alternatively, the plane of the latch wire groove 111 may be perpendicular to the latch wire sleeve 11. Optionally, the circumferential length of the locking wire groove 111 occupies more than 1/2 of the circumference of the locking wire sleeve 11, so that the success rate of hooking the artificial chordae tendineae 200 by the locking wire groove 111 is high, the locking wire groove 111 can more stably maintain the state of hooking the artificial chordae tendineae 200, and the artificial chordae tendineae 200 are not easy to disengage from the locking wire groove 111.

Referring to fig. 6, the cylinder wall of the locking wire sleeve 11 is provided with at least two rows of shift grooves 112 arranged along the axial direction. In this embodiment, the gear slot 112 penetrates through the wire locking sleeve 11 to communicate the outside of the wire locking sleeve 11 with the inner cavity of the wire locking sleeve 11. In other embodiments, the shift groove 112 may not extend through the wire locking sleeve 11 to increase the structural strength of the wire locking sleeve 11.

The number of shift notches 112 per row is plural. In this embodiment, the number of shift notches 112 in a row is 4, and in other embodiments, the number of shift notches 112 may be 1, 2, 3, 5, or the like. The plurality of shift grooves 112 in each row may be uniformly arranged in the axial direction. I.e., the spacing between every two adjacent shift slots 112 is equal. The spacing between two adjacent shift slots 112 may range from 1-2 mm. The different positions of the shift grooves 112 represent different locking depths. The gear groove 112 closest to the distal end corresponds to the maximum locking depth, and the greater the length of the artificial chordae tendineae 200 that is shortened, the greater the magnitude of the regulation.

In this embodiment, the number of rows of the gear grooves 112 is two. In other embodiments, the number of rows of the shift slots 112 may be one, three, four, etc. The present invention does not specifically limit the specific structure of the gear groove 112. In other words, the shape of the shift position groove 112 may be a circular groove, a square groove, an elliptical groove, a triangular groove, or the like.

Referring to fig. 5b and fig. 7, the locking spring 12 can movably penetrate through the inner cavity of the wire locking sleeve 11. The locking elastic piece 12 includes a bearing platform 121 and at least two side wings 122 extending from the bearing platform 121 to the sides of the at least two rows of the gear slots 112. The at least two side wings 122 extend outwardly relative to the carrier 121 and are inclined toward the proximal end of the wire locking sleeve 11. The shift grooves 112 in the same row are uniformly or non-uniformly distributed along the axial direction.

The number of rows of the shift slots 112 may be greater than or equal to the number of the side wings 122. Optionally, the number of rows of shift slots 112 is equal to the number of flanks 122. Each flank 122 extends toward a different one of the shift slots 112.

In this embodiment, the shift groove 112 is disposed between the lock wire groove 111 and the proximal end M (see fig. 6) of the lock wire sleeve 11. Before the locking spring 12 pushes the artificial chordae tendineae 200, the bearing platform 121 is located between the locking wire groove 111 and the proximal end M of the locking wire sleeve 11. At least two of the side flaps 122 are bent with respect to the carrier table 121. At least two wings 122 extend along the proximal end M of the lockwire sleeve 11.

In this embodiment, referring to fig. 7, the carrier 121 is a plate perpendicular to the Y-axis direction, the number of rows of the gear slots 112 is two, and the number of the side wings 122 is two and is referred to as an example for illustration. Wherein the stage 121 extends in the X-axis direction. The two side wings 122 are symmetrically disposed on two sides of the carrier 121.

Referring to fig. 7 and 8, fig. 7 and 8 are schematic views of the locking spring 12 in the embodiment in a closed state and an open state, respectively.

At least two of the lateral wings 122 can be in a closed state or an open state under the action of external force. Specifically, the locking spring 12 is a metal sheet with resilience after high-temperature setting, and can expand and unfold without external force. Wherein the closed position is when at least two of the side wings 122 are close to each other. In this embodiment, at least two wings 122 are tucked within a push tube (see description below) of conveyor 40. When the at least two side wings 122 are separated from the push tube of the delivery device 40, the at least two side wings 122 will be unfolded under the self-deformation restoring force until the at least two side wings 122 abut against the inner wall of the wire locking sleeve 11.

Referring to fig. 7, fig. 9a and fig. 9b, when the at least two side wings 122 are in the folded state, since the at least two side wings 122 do not abut against the inner wall of the wire locking sleeve 11, the locking elastic piece 12 is not obstructed by the wire locking sleeve 11, and the locking elastic piece 12 can movably shuttle through the inner cavity of the wire locking sleeve 11. When the locking wire groove 111 of the locking wire sleeve 11 hooks the artificial chordae tendineae 200, the at least two side wings 122 are in the closed state, pushing the locking spring 12 to move axially and distally, and the bearing platform 121 pushes the artificial chordae tendineae 200 to move axially and distally along the locking wire sleeve 11 under an external force, so that the length of the artificial chordae tendineae 200 folded in the chordae regulating implant 10 is increased, and the effective length of the artificial chordae tendineae 200 is decreased.

Referring to fig. 8 and 5a, when the effective length of the artificial tendon 200 is reduced to the target length, the at least two side wings 122 are released, and the at least two side wings 122 are unfolded under their own restoring force to be respectively engaged with the retaining grooves 112, so that a portion of the artificial tendon 200 is folded and retained between the locking wire sleeve 11 and the bearing platform 121, thereby locking the tendon regulating implant 10 to the reduced length of the artificial tendon 200.

The tendon regulating implant 10 comprises a locking wire sleeve 11 and a locking elastic sheet 12 through design, the locking wire sleeve 11 is used for hooking the artificial tendon 200, and the locking elastic sheet 12 gradually brings the artificial tendon 200 into the locking wire sleeve 11 in the process of gradually entering the locking wire sleeve 11, so that the effective length of the artificial tendon 200 is reduced; when the effective length of the artificial chordae tendineae 200 is reduced to a suitable length, at least two side wings 122 of the locking elastic sheet 12 are opened and clamped in the gear groove 112 of the locking wire sleeve 11, so that the locking elastic sheet 12 is fixed to the locking wire sleeve 11, and the effective length of the artificial chordae tendineae 200 is not reduced and is fixed; in this manner, the chordae modulating implant 10 achieves the effect of adjusting the effective length of the artificial chordae 200. The tendon regulation implant 10 provided by the utility model has the characteristics of simple structure, simple and convenient regulation and control operation, reliable regulation and control effect, etc.

Referring to fig. 7 and 8, at least two of the side wings 122 are provided with barbs 123, and the barbs 123 are inclined outwards and away from the bearing platform 121 relative to the corresponding side wings 122. Referring to fig. 5b, when the at least two side wings 122 are in the open state, the barbs 123 on the at least two side wings 122 are respectively engaged with the at least two rows of the gear slots 112.

Specifically, barbs 123 extend outwardly and proximally relative to wings 122. Optionally, the included angle between the barb 123 and the flank 122 ranges from 10 ° to 45 °.

In this embodiment, each side wing 122 has 2 sets of barbs 123. Each set of barbs 123 includes two barbs 123 juxtaposed along the Z-axis (see fig. 7) to increase the engaging strength of the barbs 123 engaging with the gear groove 112. It will be appreciated that the indexing grooves 112 corresponding to the flanks 122 may be arranged in two axially-directed rows and two axially-directed columns, with two indexing grooves 112 of each row engaging with two barbs 123 of each set. Different rows of notches 112 correspond to different lock depths. The greater the depth of maximum locking of the shift notch 112 closest to the distal end and the greater the length of shortened artificial chordae tendineae 200, the greater the magnitude of the modulation. Of course, the number of sets of barbs 123, the number of barbs 123 in each set, and the number of rows and columns of the gear groove 112 in this embodiment are all examples, and those skilled in the art should also be able to perform appropriate quantity adjustment according to the present invention.

Referring to fig. 6, the cylinder wall of the lockwire sleeve 11 is further provided with at least one guide groove 113 extending along the axial direction. The guide groove 113 may or may not extend through the wall of the lockwire sleeve 11. In this embodiment, the guide groove 113 penetrates the cylinder wall of the locking wire sleeve 11. In this embodiment, a pair of oppositely disposed guide slots 113 is taken as an example for illustration, and will not be described in detail later.

Referring to fig. 7 and 8, the locking spring 12 further includes at least one positioning rod 124 extending radially outward from the carrier 121. The positioning rod 124 is slidably inserted into the guide groove 113 to guide the locking spring 12 to move axially in the wire locking sleeve 11. In this embodiment, a pair of positioning rods 124 disposed oppositely is taken as an example for illustration, and the description is omitted here. A pair of positioning rods 124 extend from the stage 121 in the X-axis direction. Referring to fig. 5a, a pair of positioning rods 124 are respectively disposed in the pair of guiding grooves 113, so that the wire locking sleeve 11 and the locking spring 12 are connected to form an integral body.

When the locking elastic piece 12 moves axially in the inner cavity of the wire locking sleeve 11, the pair of positioning rods 124 respectively slide along the pair of guiding grooves 113, so that the locking elastic piece 12 moves axially when pushed.

When the locking wire groove 111 of the locking wire sleeve 11 hooks the artificial chordae tendineae 200 or before the artificial chordae tendineae 200, the pair of positioning rods 124 respectively abut against the proximal ends of the pair of guide grooves 113. The proximal end of the guide groove 113 is flush with the proximal end of the locking wire groove 111; or, the near end of the guide groove 113 is arranged between the near end of the locking wire groove 111 and the near end M of the locking wire sleeve 11, so that the bearing table 121 is arranged between the locking wire groove 111 and the near end M of the locking wire sleeve 11, and the bearing table 121 avoids the locking wire groove 111, thereby avoiding interference caused by the artificial chordae tendineae 200 entering the locking wire groove 111.

In this embodiment, referring to fig. 6, a part of one guide slot 113 of the pair of guide slots 113 coincides with the locking slot 111, and another part of one guide slot 113 of the pair of guide slots 113 extends from an inner wall of the locking slot 111 along an axial direction toward the distal end N of the locking sleeve 11, so that the guide slots 113 and the locking slot 111 are spatially multiplexed, and a proximal end of the guide slot 113 is a proximal end of the locking slot 111, so that the carrier table 121 does not interfere with the entry of the artificial chordae tendineae 200 into the locking slot 111; the other guide groove 113 of the pair of guide grooves 113 is disposed opposite to the wire locking groove 111 in the radial direction.

After the locking wire groove 111 of the locking wire sleeve 11 hooks the artificial tendon 200, under an external force, the pair of positioning rods 124 of the locking elastic sheet 12 slide along the pair of guide grooves 113 to ensure that the locking elastic sheet 12 moves in the axial direction when pushed, in this process, the pair of side wings 122 of the locking elastic sheet 12 are always kept in a closed state, the carrying platform 121 of the locking elastic sheet 12 abuts against the artificial tendon 200 and pushes the artificial tendon 200 to move towards the distal end N of the locking wire sleeve 11, so that the length of the artificial tendon 200 entering the locking wire sleeve 11 is gradually increased, and the effective length of the artificial tendon 200 is gradually shortened. The cooperation of the locking wire sleeve 11 and the locking spring 12 locks part of the artificial chordae tendineae 200 into a "zigzag" shape or an inverted "U" shape to shorten the effective length of the artificial chordae tendineae 200. When the effective length of the artificial chordae tendineae 200 reaches the appropriate length, the locking elastic sheet 12 is pushed to the appropriate position in the locking wire sleeve 11 along the axial direction, the pair of side wings 122 of the locking elastic sheet 12 are released and opened, the barbs 123 on the pair of side wings 122 are embedded into the corresponding shift grooves 112 under the action of elastic force to fix the axial position, so that the locking elastic sheet 12 is fixed in the locking wire sleeve 11 to lock the shortened length of the artificial chordae tendineae 200, and the artificial chordae tendineae 200 maintain the appropriate effective length.

Referring to fig. 6, a pair of first connection holes 114, which are oppositely arranged and radially symmetrical, are formed in the cylinder wall of the wire locking sleeve 11. The first connection hole 114 can be disposed between two oppositely disposed shift slots 112. The first connection hole 114 is adapted to connect with the carrier 40 to connect the chordae regulating implant 10 to the carrier 40.

With reference to fig. 9a to 12b, the process of the chordae modulating implant 10 acting on the artificial chordae 200 is divided into four stages:

in the first stage, referring to fig. 9a and 9b, the artificial chordae tendineae 200 are hooked by the locking wire slot 111 of the locking wire sleeve 11 and enter the locking wire slot 111.

At the second stage, please refer to fig. 10a and fig. 10b, the locking spring 12 is pushed to move axially and distally. The locking line groove 111 is pushed to the far end by the bearing platform 121 of the locking elastic sheet 12 in the contraction state. The artificial chordae tendineae 200 are retracted into the locking wire sleeve 11 and contracted in a zigzag shape.

In the third stage, referring to fig. 11a and 11b, when the stroke of the artificial chordae tendineae 200 is contracted to a suitable length, that is, the backflow condition is just completely eliminated, the locking spring 12 stops moving axially, and then the axially symmetric side wings 122 of the locking spring 12 are automatically opened. The barbs 123 on the side wings 122 are embedded into the shift grooves 112 of the locking wire sleeve 11, so that the locking spring 12 is fixed at a set position. Since the shift grooves 112 are arranged at equal intervals in the axial direction. When the locking elastic sheet 12 is released at different positions, the locking position is also different. The depth of the lock may be determined by the length of artificial chordae 200 that needs to be shortened. If the locking elastic sheet 12 is released, the artificial chordae tendineae 200 still need to be shortened, and the bearing platform 121 of the locking elastic sheet 12 can be pushed to the far end continuously. During this process, the barbs 123 can disengage from one gear groove 112 and retract until pushing ceases and then re-engage another gear groove 112 further distally, thereby adjusting the artificial chordae tendineae 200 to the desired length. After the adjustment is completed, the carrier 121 does not move proximally due to the barbs 123, so that the effective length of the shortened artificial chordae tendineae 200 does not change.

In the fourth stage, please refer to fig. 12a and 12b, the wire locking sleeve 11 is disengaged from the conveyor 40.

The structure of the conveyor 40 will be described below by way of example with reference to the accompanying drawings.

Referring to fig. 3, an embodiment of the present invention provides a tendon control device 30. The chordae regulating device 30 includes a delivery 40 and the chordae regulating implant 10 of any of the embodiments described above.

Referring to fig. 13 and 14, the delivery device 40 includes a conduit 41, a connector 43, a control handle 42 and a pushing assembly 44.

Referring to fig. 13, a connector 43 is attached to the distal end of the catheter 41. The connector 43 is adapted to connect to the locking wire sleeve 11 of the chordae modulating implant 10. It will be appreciated that the connector 43 is removably attachable to the chordae modulating implant 10.

The tube body structure of the conduit 41 is a woven net structure, and is mainly formed by hot melting and compounding high polymer materials. The conduit 41 can be bent. Referring to fig. 1, when the catheter 41 is disposed in the sheath 21 of the adjustable sheath 20, the catheter 41 can be bent along with the bending of the sheath 21 to deliver the artificial chordae 200 to the position of the chordae modulating implant 10 connected to the connector 43.

Referring to fig. 14, a control handle 42 is attached to the proximal end of the catheter 41.

Referring to fig. 13 and 14, the pushing assembly 44 is disposed in a receiving space formed by the inner cavity of the connecting member 43, the inner cavity of the catheter 41 and the inner cavity of the control handle 42. The pusher assembly 44 is disposed coaxially with the catheter 41.

Referring to fig. 13 and 14, the proximal end of the pushing assembly 44 extends out of the proximal end of the catheter 41 and is connected to the adjustment handle 42. The adjustment handle 42 can control the axial displacement of the pusher assembly 44. The distal end of the pushing component 44 is located in the inner cavity of the connecting member 43 and is used for pushing the locking spring 12 of the chordae regulating implant 10.

The pushing assembly 44 brings at least two wings 122 of the locking spring 12 of the chordae regulating implant 10 to a closed state or an open state under the action of the regulating handle 42. The pushing assembly is controlled by the control handle to push the locking spring 12 of the chordae tendineae control implant 10 to move axially and separate the connecting piece 43 from the locking wire sleeve 11 of the chordae tendineae control implant 10.

By arranging the catheter 41, the connecting member 43 and the adjusting handle 42 in the conveyor 40, wherein the inner cavities of the catheter 41, the connecting member 43 and the adjusting handle 42 are communicated with each other, and arranging the pushing assembly 44 in the inner cavities of the catheter 41, the connecting member 43 and the adjusting handle 42, the pushing assembly 44 can make at least two side wings 122 of the locking elastic sheet 12 of the tendon adjusting implant 10 in a folded state under the action of the adjusting handle 42 and push the locking elastic sheet 12 in the folded state to move along the axial direction of the locking sleeve 11, so that a part of the artificial tendon 200 is folded and limited between the locking sleeve 11 and the bearing table 121, and further the effective length of the artificial tendon 200 is reduced, and when the effective length of the artificial tendon 200 is reduced to a suitable length, the pushing assembly 44 releases the at least two side wings 122 of the locking elastic sheet 12, so that the at least two side wings 122 of the locking elastic sheet 12 are opened and clamped in the gear groove 112, so that the locking elastic sheet 12 is fixed on the locking wire sleeve 11, and the effective length of the artificial chordae tendineae 200 is locked without being reduced; the connector 43 is detachably connectable to the chordae modulating implant 10 to effect modulation and release of the chordae modulating implant 10 to secure the chordae modulating implant 10 to the artificial chordae 200. In this way, the tendon control device 30 enables adjustment of the effective length of the artificial tendon 200 and fixation of the tendon control implant 10 to the artificial tendon 200. The tendon regulation and control device 30 provided by the utility model has the characteristics of simple structure, simple and convenient regulation and control operation, reliable regulation and control effect, etc.

Referring to fig. 14, the control handle 42 includes a control knob 421 and a control handle housing 422. A steering knob 421 is provided at the distal end of the adjustment handle 42. Catheter 41 passes through steering knob 421 from the proximal end of steering knob 421. The distal end of the adjustment handle housing 422 is connected to the proximal end of the steering knob 421. The steering knob 421 is rotatable relative to the regulating handle housing 422 about the axial direction of the catheter 41.

Referring to fig. 13 and 14, the pushing assembly 44 includes a pushing tube seat 441 and a pushing tube 442 coaxially disposed with the pushing tube seat 441. The push tube seat 441 is disposed in the regulation handle case 422.

Referring to fig. 15, the distal end of the push tube seat 441 is threaded. The distal end of the push tube seat 441 is screwed with the proximal end of the control knob 421. The push tube 442 is movably inserted into the guide tube 41. The distal end of the push tube 442 is disposed in the connecting member 43, the push tube 442 movably penetrates through the inner cavity of the connecting member 43, the inner cavity of the catheter 41 and the inner cavity of the push tube holder 441, and the proximal end of the push tube 442 is fixedly connected with the proximal end of the push tube holder 441.

When the control knob 421 rotates around a direction, the push tube seat 441 can drive the push tube 442 to gradually move towards the distal end along the axial direction; when the control knob 421 rotates in the opposite direction, the push tube seat 441 can drive the push tube 442 to move gradually and axially toward the proximal end.

Referring to fig. 9b, the distal end of the push tube 442 is used to bind the proximal ends of the at least two side wings 122 of the locking spring 12, so that the at least two side wings 122 of the locking spring 12 are in the folded state. Specifically, the push tube 442 is a circular tube. The at least two side wings 122 of the locking spring 12 are folded in the inner cavity space at the distal end of the push tube 442, so that the at least two side wings 122 of the locking spring 12 are in a folded state.

When the push tube seat 441 drives the push tube 442 to move toward the proximal end in the axial direction under the action of the control knob 421, the push tube 442 is gradually separated from the two side wings 122 of the locking elastic sheet 12, and after the two side wings 122 of the locking elastic sheet 12 are no longer subjected to the restraining force of the push tube 442, the two side wings are unfolded and fastened in the at least two rows of the gear grooves 112 under the self deformation restoring force. In this way, the locking spring 12 is fixed in position in the locking wire sleeve 11, and the tendon control implant 10 locks the folded length of the artificial tendon 200.

Referring to fig. 13 and 14, the pushing assembly 44 further includes a pushing rod 443 and a pushing rod seat 444 fixed to a proximal end of the pushing rod 443. The push rod 443 movably penetrates through the inner cavity of the push tube 442.

In the initial state, referring to fig. 9b, the two side wings 122 at the proximal end of the locking spring 12 are retracted into the inner cavity of the push tube 442 and are abutted by the distal end of the push rod 443. The locking spring 12 and the push tube 442 are jointly disposed in the inner cavity of the connecting member 43 at the distal end of the catheter 41.

Referring to FIG. 16, a small distal area (about 10-20mm) of the push tube 442 is a rigid tube 4421. The main body area of the push tube 442 is a flexible tube 4422 with some support and compliance. The flexible tube 4422 may be generally selected from stainless steel snake bone tubes to accommodate a tortuous vascular access for insertion through the catheter 41. The push rod 443 is a metal rod having elasticity and support. A nickel titanium material is preferred. The distal end of the push rod 443 and the locking spring 12 are tightened in the rigid tube 4421 at the distal end of the push tube 442. The push rod 443 abuts the locking spring 12 and provides support for the locking spring 12.

Referring to fig. 14 and 15, the proximal end of the push rod 443 extends out of the proximal end of the push rod seat 441 and is fixedly connected with the push rod seat 444. A push rod seat 444 is provided within the adjustment handle housing 422. The distal end of the push rod seat 444 is disposed opposite the proximal end of the push tube seat 441. The distal end of the push rod seat 444 is connected with the proximal end of the push rod seat 441 through an elastic element 445.

The elastic member 445 includes, but is not limited to, a spring plate, elastic plastic, etc., and the embodiment takes the elastic member 445 as an example for description.

When the control knob 421 rotates around a direction, the push tube seat 441 drives the push tube 442 to move axially and distally under the action of the control knob 421, the push tube seat 441 stretches the elastic member 445 and drives the elastic member 445 to move distally, and the elastic member 445 drives the push rod seat 444 and the push rod 443 to move axially and distally under the action of the push tube seat 441. In this way, the push rod 443 and the push tube 442 can both push the locking spring 12 in the closed state to move axially and distally, so that the locking spring 12 shortens the effective length of the artificial chordae tendineae 200.

Referring to fig. 14 and 15, the adjustment handle 42 further includes a stopping component 423 disposed on a side of the push rod seat 444 facing away from the push rod 443. The stop assembly 423 includes a stop valve 45 and a crimp button 46 coupled to the stop valve 45. The stop valve 45 is disposed within the regulator grip housing 422 opposite the proximal end of the push rod seat 444. There is no connection between the stop valve 45 and the pushrod seat 444. The press button 46 is mounted on the adjustment handle housing 422 for controlling the axial movement or stop of the stop valve 45 to abut against the push rod seat 444 or to be separated from the push rod seat 444.

Referring to fig. 14 and 15, the number of the press buttons 46 is two. The two press buttons 46 are symmetrically arranged on two opposite sides of the stop valve 45. The press button 46 includes a stopper 461, a compression spring 462, an engaging piece 463, and a pressing piece 464. The engagement element 463 has a first tooth 465. The inner surface of the adjustment handle housing 422 has second teeth 424 which engage the first teeth 465. The stopper 461 is connected between the engagement piece 463 and the stopper valve 45. The retaining posts 461 are embedded inside the press button 46 for fixation. The compression spring 462 is sleeved on the position-limiting post 461 and compressed between the engaging element 463 and the stop valve 45. One end of the pressing piece 464 is arranged outside the regulating handle shell 422. The other end of the pressing member 464 penetrates the adjustment handle housing 422 and is connected to the engaging member 463. The compression spring 462 is a compression spring. Under the normal state, the compression spring 462 props against the pressing piece 464, so that the first teeth 465 on the inner side of the pressing piece 464 are meshed with the second teeth 424 on the inner side of the regulating handle shell 422, and the axial position of the stop valve 45 can be relatively fixed. When the pressing members 464 on both sides are pressed, the first teeth 465 on the inner side of the pressing members 464 are separated from the second teeth 424 on the inner side of the regulating handle housing 422, and the stop valve 45 can be axially displaced.

When the pressing member 464 is pressed, the pressing spring 462 is compressed, the pressing member 464 moves toward the stopper valve 45, and the first teeth 465 of the engaging member 463 are separated from the second teeth 424 of the inner surface of the lever housing 422. The pressing member 464 moves axially and distally to move the stop valve 45 until the stop valve 45 abuts against the proximal end of the plunger seat 444. When the pressing member 464 is released, the pressing member 464 is no longer pressed, the pressing member 464 is far away from the stop valve 45 under the deformation restoring force of the compression spring 462, and the first teeth 465 of the engaging member 463 are engaged with the second teeth 424 on the inner surface of the regulating handle housing 422 to lock the position of the stop valve 45 and the axial position of the push rod 443.

With reference to fig. 9b and 10b, when the artificial tendon 200 is hooked by the locking wire groove 111 of the locking wire sleeve 11 and enters the locking wire groove 111, the manipulation knob 421 rotates in a direction, the push tube seat 441 drives the push tube 442 to move axially and distally under the action of the manipulation knob 421, the push tube seat 441 stretches the elastic member 445 and drives the elastic member 445 to move distally, the elastic member 445 drives the push rod seat 444 and the push rod 443 to move axially and distally under the action of the push tube seat 441, the push rod 443 and the push tube 442 move distally together and push the locking spring 12 to move distally, the bearing platform 121 of the locking spring 12 pushes the artificial tendon 200 to move distally, and the effective length of the artificial tendon 200 is gradually shortened.

Referring to fig. 15, when the effective length of the artificial chordae tendineae 200 is decreased to the target length, the pressing element 464 is pressed, the first teeth 465 of the engaging element 463 are separated from the second teeth 424 of the inner surface of the control handle housing 422, and the pressing element 464 moves axially and distally to drive the stop valve 45 to move until the stop valve 45 abuts against the push rod seat 444. The target length of the artificial chordae 200 is the state in which the artificial chordae 200 is in a moderate tension between the leaflets and the ventricular wall and mitral regurgitation is absent or minimal.

Referring to fig. 11b, when the stop valve 45 abuts against the push rod seat 444 and the push rod seat 441 drives the push tube 442 to move axially and proximally under the action of the manipulation knob 421, the push rod 443 is kept abutting against the proximal ends of the at least two wings 122 under the action of the stop valve 45. The push tube 442 moves proximally relative to the push rod 443 by compressing the elastic member 445 and gradually separates from the at least two side wings 122, the at least two side wings 122 of the locking spring 12 open due to the loss of the binding force of the push tube 442, and the at least two side wings 122 of the locking spring 12 are engaged with the corresponding shift grooves 112, so that the tendon control implant 10 locks the effective length of the artificial tendon 200.

With reference to fig. 12b and 13, a pair of second connection holes 431 is disposed on the outer peripheral surface of the distal end of the connection member 43 and communicates with the inner cavity of the connection member 43.

Referring to fig. 9b and 12b, the conveyor 40 further includes a pair of connecting elastic pieces 47 disposed opposite to each other.

Referring to fig. 12b, the proximal end of the connecting spring 47 is engaged with the wall of the connecting member 43. Specifically, the wall surface of the proximal end of the connecting piece 43 is provided with a slot 432 penetrating through the wall surface of the connecting piece 43, the proximal end of the connecting elastic piece 47 is hook-shaped, and the proximal end of the connecting elastic piece 47 is clamped with the proximal end of the connecting piece 43 through the slot 432. The proximal end of the connecting spring 47 is fixed in the slot 432 of the proximal end of the connecting piece 43.

The material of the connecting elastic sheet 47 is preferably a metal elastic sheet (such as nickel titanium), and the near end of the connecting elastic sheet 47 can be connected with the near end of the connecting piece 43 in a laser welding mode; the connecting elastic sheet 47 may also be made of plastic elastic sheet, and the plastic elastic sheet may connect the proximal end of the connecting elastic sheet 47 with the proximal end of the connecting piece 43 by ultrasonic welding.

Referring to fig. 9b, the middle portion of the connecting elastic piece 47 abuts against the outer circumferential surface of the push tube 442. The pair of connecting resilient pieces 47 are symmetrically disposed on opposite sides of the outer circumferential surface of the push tube 442, respectively, so as to abut against the distal end of the push tube 442.

Referring to fig. 9b, the distal end of the connecting spring 47 is of an inverted structure. Wherein the distal end of the connection spring piece 47 extends radially outward toward the connection piece 43. The distal end of the connecting spring piece 47 is movably inserted into the second connecting hole 431 of the connecting piece 43. The distal end of the connecting spring piece 47 is retracted in the connecting piece 43 in the free state. When the distal end of the push tube 442 passes through the gap between the pair of connection resilient pieces 47, the pair of connection resilient pieces 47 are respectively spread outward, and the middle portions of the connection resilient pieces 47 are subjected to a radially outward force of the push tube 442 toward the connection member 43.

Referring to fig. 9b, the distal end of the connection elastic piece 47 is offset toward the second connection hole 431 of the connection piece 43 and passes through the second connection hole 431. When the outer peripheral surface of the push tube 442 pushes against the connecting elastic piece 47, the connecting piece 43 is abutted against the wire locking sleeve 11, and the second connecting hole 431 is aligned with the first connecting hole 114 on the wire locking sleeve 11, the distal end of the connecting elastic piece 47 can be simultaneously clamped in the second connecting hole 431 of the connecting piece 43 and the first connecting hole 114 of the wire locking sleeve 11, so that the connecting piece 43 is connected with the wire locking sleeve 11, and the wire locking sleeve 11 is locked with the conveyor 40. Thus, the locking elastic piece 12 is pushed by the push rod 443 and moved by the subsequent push tube 442, and the locking elastic piece 12 can move relative to the locking wire sleeve 11, so that the effective length of the artificial chordae tendineae 200 is gradually reduced as the locking elastic piece 12 gradually enters the locking wire sleeve 11.

When the at least two side wings 122 of the chordae tendineae regulatory implant 10 are engaged with the at least two rows of the shift grooves 112, respectively, the push tube 442 and the push rod 443 axially move proximally under the action of the control knob 421 to withdraw from between the pair of connecting resilient pieces 47, and separate from the pair of connecting resilient pieces 47. When the push tube 442 and the push rod 443 axially move toward the proximal end to be separated from the connecting spring pieces 47, the pair of connecting spring pieces 47 lose the abutting force of the push tube 442, and the distal ends of the connecting spring pieces 47 are all close to the center of the inner cavity of the connecting piece 43 under the self-deformation restoring force. The distal end of the connecting elastic piece 47 moves out of the first connecting hole 114 and the second connecting hole 431 to separate the connecting piece 43 from the wire locking sleeve 11, so as to unlock the connecting piece 43 from the tendon control implant 10, and the tendon control implant 10 is released from the distal end of the connecting piece 43 and fixed to the artificial tendon 200.

The control steps of the chordae regulating device 30 are as follows:

referring to fig. 9b and 14, in a first stage, the chordae regulating implant 10 is connected to the connector 43 of the transporter 40. The distal ends of a pair of attachment clips 47 each snap into the locking wire sleeve 11 of the chordae regulating implant 10 and the attachment 43 of the carrier 40. The middle parts of the pair of connecting elastic pieces 47 are symmetrically abutted against the two sides of the outer peripheral surface of the distal end of the push tube 442. The proximal end of the locking spring 12 is embedded in the inner cavity of the distal end of the push tube 442, and the distal end of the push rod 443 abuts against the proximal end of the locking spring 12 in the push tube 442.

The distal end of the adjustable sheath 20 is arranged near the artificial chordae tendineae 200 by manipulating the adjustable sheath 20, and the steering of the adjustable sheath 20 is adjusted so that a portion of the artificial chordae tendineae 200 pass through the locking wire groove 111 of the chordae tendineae adjusting implant 10. The position of the catheter 41 is appropriately adjusted to place the artificial chordae tendineae 200 in a relatively slack state.

Referring to fig. 10a, 10b and 14, in the second stage, the operation knob 421 is rotated, the operation knob 421 drives the push tube seat 441 and the push tube 442 to move towards the distal end, the push tube seat 441 drives the push rod 443 to move towards the distal end synchronously through the elastic member 445, the push tube 442 and the push rod 443 push the locking spring 12 together to push the artificial tendon 200 to move towards the distal end along the axial direction, and the artificial tendon 200 is shaped like a Chinese character 'ji' in the wire locking sleeve 11. Observing the ultrasonic image and the DSA image, and determining whether the contraction degree of the locking elastic sheet 12 to the artificial chordae tendineae 200 is appropriate to determine whether to continuously adjust the locking depth of the locking elastic sheet 12.

Referring to fig. 14 and 15, if mitral regurgitation is lost, the artificial chordae tendineae 200 are determined to be contracted to a desired extent. When the effective length of the artificial chordae tendineae 200 is the proper length, the pressing piece 464 of the crimping button 46 is pressed, the first teeth 465 of the engaging piece 463 are separated from the second teeth 424 of the inner surface of the regulating handle shell 422, the pressing piece 464 moves towards the far end along the axial direction to drive the stop valve 45 to move until the stop valve 45 abuts against the push rod seat 444, the pressing piece 464 of the crimping button 46 is released, the first teeth 465 of the engaging piece 463 are engaged with the second teeth 424 of the inner surface of the regulating handle shell 422, and the axial position of the stop valve 45 is fixed, so that the axial position of the push rod 443 is locked.

Referring to fig. 11a, fig. 11b and fig. 14, in the third stage, the operation knob 421 is rotated reversely, the push tube seat 441 and the push tube 442 are driven by the operation knob 421 to move towards the proximal end, but the push tube 442 still supports the pair of connection elastic pieces 47, the push rod 443 cannot move due to the blocking of the stop valve 45, and the elastic piece 445 is compressed. The proximal end of the locking spring 12 cannot move along with the push tube 442 due to the blocking of the push rod 443, the push tube 442 is separated from the proximal end of the locking spring 12, and the pair of wings 122 of the locking spring 12 gradually extend out from the distal end of the push tube 442 until being completely released. When the locking elastic sheet 12 is completely released, the axially symmetrical lateral wings 122 of the locking elastic sheet 12 are automatically expanded and opened, and the barbs 123 on the lateral wings 122 are embedded into the gear slots 112 of the locking wire sleeve 11, so that the locking elastic sheet 12 is fixed at the set position. In this manner, the chordae modulating implant 10 locks the effective length of the artificial chordae 200.

Pressing the press element 464 of the crimp button 46 moves the stop valve 45 proximally. The resilient member 445 urges the pusher 443 proximally.

Referring to fig. 12a, 12b and 14, in the fourth stage, the operation knob 421 is continuously rotated in the reverse direction, the operation knob 421 drives the push tube seat 441 and the push tube 442 to move towards the proximal end, at this time, the push rod 443 is no longer blocked by the blocking valve 45, the push rod 443 is driven by the push tube seat 441 to move towards the proximal end, the push rod 443 and the push tube 442 are withdrawn from between the pair of connection elastic pieces 47, the inner sides of the pair of connection elastic pieces 47 lose the supporting force, and the distal ends of the pair of connection elastic pieces 47 are retracted into the inner cavity of the connecting member 43, so as to unlock the wire locking sleeve 11 and the connecting member 43. The chordae regulating implant 10 is released distally from the delivery device 40 for ease of operation.

The embodiment of the present invention is illustrated with reference to the attached drawings for illustrating the structure of the adjustable sheath 20.

Referring to fig. 2, the adjustable bending sheath 20 includes a sheath 21 and a bending control handle 22 connected to a proximal end of the sheath 21. The bending control handle 22 is used for controlling the bending of the distal end of the sheath tube 21, and the catheter 41 is movably arranged in the inner cavity of the sheath tube 21 and the inner cavity of the bending control handle 22 in a penetrating manner.

Referring to fig. 17, the distal end of the sheath 21 has a bending adjusting function, the bending angle ranges from 0 to 180 °, and the length of the bending adjusting region ranges from 30 to 50 mm.

The sheath 21 is a woven net structure and is mainly formed by hot melting and compounding high polymer materials. The distal end of the sheath 21 is an elastic section which can be freely bent within a certain angle range and can actively return to the initial angle direction. Between the resilient section and the proximal end of the sheath 21 is a longer and stiffer rigid tube section. The distal end of the sheath tube 21 is provided with a smooth arc-shaped end surface so as to reduce the damage of the distal end of the sheath tube 21 to the inner wall of the blood vessel of the human body.

At least one delivery lumen and at least one filament lumen are provided within sheath 21. The delivery lumen extends completely through sheath 21 from the distal end to the proximal end of sheath 21. The filament lumen is embedded within the wall of the sheath 21. The distal end of the filament lumen is provided with at least one anchoring ring. A pull wire 23 is disposed within the filament lumen.

Referring to fig. 18, the distal end of the pull wire 23 is fixed to the anchoring ring and exits the side wall of the sheath 21 near the proximal end along the filament lumen and is connected to the drive slide 221 of the bend adjustment control handle 22.

The bending control handle 22 in this embodiment has a function of controlling the bending of the distal end of the sheath 21 and the overall twisting of the sheath 21.

Referring to fig. 18, the drive mode of the bending control handle 22 is screw transmission. The outer circumferential surface of the transmission slider 221 is provided with an external thread. The proximal end of the bend adjustment control handle 22 is provided with a rotary cylinder 222. The inner side of the rotary cylinder 222 is provided with an internal thread matched with the external thread of the transmission slide block 221.

Referring to fig. 18, the action mechanism of the screw transmission of the bending control handle 22 is: the rotary cylinder 222 can rotate clockwise or counterclockwise, and the rotary cylinder 222 is rotated to move the transmission slide 221 in the axial direction. In this embodiment, the rotary cylinder 222 at the distal end of the bending control handle 22 rotates clockwise to drive the transmission slider 221 in the bending control handle 22 to move toward the proximal end along the axial direction, and the transmission slider 221 pulls the anchoring ring in the distal end of the sheath tube 21 through the traction wire 23, so that the bending adjusting section at the distal end of the sheath tube 21 generates the bending adjusting effect.

In this embodiment, referring to fig. 1 and fig. 9a to fig. 15, the control steps of the tendon control system 100 are as follows:

the first step is as follows: the adjustable curved sheath 20 is advanced into the aortic lumen and continues past the aortic arch, through the aortic valve and into the left ventricle.

The second step is that: the sheath 21 is fixed, the transporter 40 is pushed to bring the chordae modulating implant 10 connected to its distal end close to the artificial chordae 200, and the modulation handle 42 is twisted to direct the opening direction of the locking wire groove 111 of the chordae modulating implant 10 toward the artificial chordae 200.

The third step: the sheath 21 is bent such that the axial direction of the wire-locking sleeve 11 is perpendicular to the artificial chordae tendineae 200. The sheath 21 is then twisted to gradually apply the wire-locking sleeve 11 to the artificial chordae tendineae 200, so that the wire-locking groove 111 of the wire-locking sleeve 11 can hook the artificial chordae tendineae 200.

The fourth step: the control knob 421 at the distal end of the control handle 42 is rotated clockwise to make the locking elastic sheet 12 move toward the distal end along the axial direction, and push the artificial chordae tendineae 200 to contract toward the inside of the locking wire sleeve 11 in a shape like a Chinese character 'ji'.

The fifth step: and observing the mitral valve regurgitation state under the ultrasonic state, and stopping pushing the locking elastic sheet 12 when the regurgitation disappears. The stop valve 45 is now adjusted against the plunger seat 444, fixing the position of the plunger 443 so that the distal end of the plunger 443 abuts the proximal end of the locking spring 12.

And a sixth step: the control knob 421 at the distal end of the control handle 42 is rotated counterclockwise to axially retract the push tube 442 until the locking spring 12 is completely released. After the locking elastic sheet 12 is released, the two side wings 122 of the locking elastic sheet 12 are opened by self expansion. The barbs 123 on the side wings 122 are embedded into the corresponding position of the shift position groove 112 of the wire locking sleeve 11, so that the position of the locking spring 12 in the wire locking sleeve 11 is fixed. The contracted state of the artificial chordae 200 is also fixed at this time.

The seventh step: the crimp button 46 releases the stop valve 45 after proximal displacement, and then continues to rotate the control knob 421 at the distal end of the control handle 42 counterclockwise, so that the push tube 442 and the push rod 443 are simultaneously retracted, thereby releasing the locking of the connector 43 at the distal end of the delivery device 40 to the locking sleeve 11. The chordae modulating implant 10 is released from the distal end of the catheter 41 and thereby secured to the artificial chordae 200, residing within the heart chamber.

Eighth step: the transporter 40 and the adjustable bent sheath 20 are sequentially withdrawn in sequence, and the adjustment and control of the effective length of the artificial chordae tendineae 200 are completed.

The above is some embodiments of the present invention. It should be noted that. As would be apparent to one of ordinary skill in the art. Without departing from the principles of the present invention. Several improvements and refinements can also be made. Such modifications and refinements are also considered to be within the scope of the present invention.

Claims

1. A chordae modulating implant for adjusting the effective length of an artificial chordae comprising:

when the locking wire groove of the locking wire sleeve is hooked to the artificial chordae tendineae, the at least two side wings are in a folded state; the bearing table pushes the artificial chordae tendineae to move along the axial direction of the locking wire sleeve under the external force, so that the effective length of the artificial chordae tendineae is reduced; when the effective length of the artificial chordae tendineae is reduced to the target length, the at least two side wings are unfolded to be respectively clamped in the at least two rows of the gear grooves, so that part of the artificial chordae tendineae is folded and limited between the locking line sleeve and the bearing table.

2. The chordae modulating implant of claim 1, wherein each of the at least two side wings is provided with barbs that are angled outwardly and away from the platform relative to the respective side wing; when the at least two side wings are in the unfolding state, the barbs on the at least two side wings are respectively clamped in the at least two rows of the gear grooves.

3. The chordae modulating implant of claim 2, wherein the shift groove is provided between the locking wire groove and the proximal end of the locking wire sleeve; at least two flanks are relative the plummer all outwards simultaneously towards the telescopic proximal end direction slope of lockwire extends, the barb is corresponding relatively the flank outwards simultaneously to the telescopic proximal end direction slope of lockwire extends.

4. The chordae tendineae modulation implant of claim 3, wherein the barrel wall of the locking wire sleeve is further provided with at least one guide slot extending axially, and the locking spring plate is provided with at least one positioning rod extending radially outward from the bearing platform; the positioning rod is inserted into the guide groove in a sliding mode so as to guide the locking elastic sheet to move in the wire locking sleeve along the axial direction.

5. The chordae modulating implant of claim 4, wherein the proximal end of the guide groove is flush with the proximal end of the lockwire groove or the proximal end of the guide groove is disposed between the proximal end of the lockwire groove and the proximal end of the lockwire sleeve.

6. The chordae modulating implant of claim 1, wherein the barrel wall of the wire locking sleeve further defines a pair of oppositely disposed first connection holes for connection to a delivery device.

7. The chordae modulating implant of any one of claims 1 to 6, wherein the locking wire slot extends for a length in the circumferential direction greater than or equal to 1/2 circumference of the locking wire sleeve.

8. The chordae modulating implant of any one of claims 1-6, wherein the shift grooves of a same row are distributed axially uniformly or non-uniformly.

9. A chordae regulating device comprising a chordae regulating implant as claimed in any one of claims 1 to 8 and a conveyor comprising:

the connecting piece is detachably connected with a locking wire sleeve of the chordae tendineae regulating implant;

a control handle connected to the proximal end of the catheter; and

the push assembly is arranged in an accommodating space formed by an inner cavity of the connecting piece, an inner cavity of the catheter and an inner cavity of the regulation and control handle, the near end of the push assembly is connected with the regulation and control handle, the far end of the push assembly enables at least two side wings of a locking elastic sheet of the tendon rope regulation and control implant to be in a furled state or an opened state, the push assembly is controlled by the regulation and control handle to push the locking elastic sheet of the tendon rope regulation and control implant to move axially and enable the connecting piece to be separated from the wire locking sleeve.

10. The chordae regulating device of claim 9, wherein the regulating handle comprises a steering knob at a distal end thereof;

the pushing assembly comprises a pushing pipe seat and a pushing pipe which is coaxial with the pushing pipe seat, the far end of the pushing pipe seat is in threaded connection with the control knob, and the pushing pipe seat is fixedly connected with the near end of the pushing pipe; the push tube is movably arranged in the inner cavity of the catheter and the inner cavity of the connecting piece in a penetrating manner, and the far end of the push tube is used for restraining the near ends of at least two side wings of the locking elastic sheet so as to enable the at least two side wings of the locking elastic sheet to be in a folded state; when the push pipe seat drives the push pipe to move towards the near end along the axial direction under the action of the control knob, the push pipe is gradually separated from the at least two side wings of the locking elastic sheet, and the at least two side wings of the locking elastic sheet are unfolded and clamped in the at least two rows of the gear grooves.

11. The tendon regulating device of claim 10 wherein the pushing assembly further comprises a pushing rod and a pushing rod seat fixedly connected to a proximal end of the pushing rod, the pushing rod movably penetrates the pushing tube, a distal end of the pushing rod is configured to abut against proximal ends of the at least two side wings, the proximal end of the pushing rod extends out of the proximal end of the pushing tube seat, and the pushing rod seat is connected to the pushing tube seat through an elastic member.

12. The chordae tendineae modulation device of claim 11, wherein the modulation handle further comprises a modulation handle housing connected to the proximal end of the manipulation knob, the push tube seat and the elastic member being disposed within the modulation handle housing;

the regulating handle further comprises a stop component arranged on one side, away from the push rod, of the push rod seat, the stop component comprises a stop valve and a crimping button connected with the stop valve, the stop valve is arranged opposite to the push rod seat, and the crimping button is arranged on the regulating handle shell;

the crimping button is used for controlling axial movement or stopping of the stop valve so as to abut against the push rod seat or be separated from the push rod seat.

13. The tendon control device according to claim 12, wherein the number of the press buttons is two, two of the press buttons are symmetrically disposed on opposite sides of the stop valve, the press buttons include a position-limiting post, a compression spring, an engaging member having a first tooth, and a pressing member having a second tooth engaged with the first tooth, the position-limiting post is connected between the engaging member and the stop valve, the compression spring is sleeved on the position-limiting post and compressed between the engaging member and the stop valve, one end of the pressing member is disposed outside the control handle housing, and the other end of the pressing member penetrates the control handle housing and is connected to the engaging member.

14. The chordae tendineae modulation device of claim 11, wherein a pair of second connection holes are provided on the outer circumferential surface of the distal end of the connector to connect the inner lumen of the connector;

the conveyer also comprises a pair of oppositely arranged connecting elastic sheets, and the near ends of the connecting elastic sheets are clamped with the wall surface of the connecting piece;

when the outer peripheral surface of the push pipe abuts against the connecting elastic sheet, the far end of the connecting elastic sheet is clamped with the second connecting hole and the first connecting hole in the wire locking sleeve, so that the connecting piece is connected with the wire locking sleeve;

when the push pipe and the push rod move towards the near end along the axial direction to be separated from the connecting elastic sheet, the far end of the connecting elastic sheet is close to the center and moves out of the first connecting hole and the second connecting hole, so that the connecting piece is separated from the locking wire sleeve.

15. A tendon regulating system comprising an adjustable bending sheath and the tendon regulating device according to any one of claims 9 to 14, wherein the adjustable bending sheath comprises a sheath tube and a bending control handle connected to a proximal end of the sheath tube, the bending control handle is used for controlling the distal bending of the sheath tube, and the catheter is movably inserted into an inner cavity of the sheath tube and an inner cavity of the bending control handle.