WO2021135450A1 - Chordae tendineae regulation implant, chordae tendineae regulation device, and chordae tendineae regulation system - Google Patents

Abstract

A chordae tendineae regulation implant (10) simple in structure and convenient to operate, a chordae tendineae regulation device (30), and a chordae tendineae regulation system (100). The chordae tendineae regulation implant (10) comprises: a lock line sleeve (11), a sleeve wall being provided with a lock line groove (111), and the lock line groove (111) extending in a circumferential direction of the lock line sleeve (11); at least two columns of gear grooves (112) arranged in an axial direction and provided on the sleeve wall of the lock line sleeve (11); and a locking elastic piece (12) provided in an inner cavity of the lock line sleeve (11) and comprising a bearing table (121) and at least two side wings (122). When the lock line groove (111) of the lock line sleeve (11) is hooked to an artificial chordae tendineae (200), the at least two side wings (122) are in a folded state, and the bearing table (121) pushes the artificial chordae tendineae (200) to move along the axial direction of the lock line sleeve (11) under the external force, so that the effective length of the artificial chordae tendineae (200) is reduced; when the effective length of the artificial chordae tendineae (200) is reduced to a target length, the at least two side wings (122) are unfolded to be clamped in the at least two columns of gear grooves (112), respectively, so that part of the artificial chordae tendineae (200) is folded and limited between the lock line sleeve (11) and the bearing table (121).

Description

Tendon cord control implant, tendon cord control device and tendon cord control system Technical field

The application relates to the technical field of medical devices, and in particular to a chordal control implant, a chordal control device, and a chordal control system.

Background technique

The mitral valve is a one-way "valve" between the left atrium and the left ventricle, which ensures that blood flows from the left atrium to the left ventricle. A normal healthy mitral valve has multiple chordae. The leaflets of the mitral valve are divided into anterior leaflets and posterior leaflets. When the left ventricle is in a diastolic state, the two are in an open state, and blood flows from the left atrium to the left ventricle; when the left ventricle is in a contracted state, the chordae tendons are stretched to ensure The valve leaflets will not be rushed to the atrium side by blood flow, and the anterior and posterior leaflets are closed well, thus ensuring that blood flows from the left ventricle to the aorta through the aortic valve. If the chordae chordae is pathological, such as chordal rupture, when the left ventricle is in a contracted state, the mitral valve cannot return to the closed state as in the normal state, and the impulse of blood flow will further cause the valve leaflets to fall into the left atrium, causing blood reflux .

For mitral valve regurgitation, surgical operation is an effective treatment method, but it is more traumatic to the human body. Minimally invasive interventional treatment methods include artificial chordae implantation, mitral annuloplasty, and mitral valve edge-to-edge Repair surgery, in which artificial chordae is implanted on the valve leaflets, which can effectively treat the mitral valve insufficiency and regurgitation caused by chordae rupture and leaflet prolapse. The principle of artificial chordal implantation is to fix one side of the artificial chord on the valve leaflet, and the other side on the papillary muscle or myocardial wall, and replace the native chord with the artificial chord to pull the mitral valve leaflet. To restore it to the normal on-off state, in order to achieve the purpose of treating mitral regurgitation.

Before the implantation of the artificial chordae, due to the insufficiency of the mitral valve, the left ventricle's ability to pump blood to the aorta is limited, and the pressure increases. The left ventricle is likely to be in a dilated state under long-term illness. According to statistics, for patients with severe MR, the left ventricular end diastolic diameter (LVDd) and left ventricular end systolic diameter (LVDs) are on average 11mm and 8mm higher than those of normal subjects, respectively. Compared with mild MR patients, LVDd and LVDs The average height is about 2mm and 3.5mm respectively. After the artificial chordae is implanted, patients with severe MR will switch to mild MR or the reflux will disappear completely. At this time, the volume of the left ventricle will gradually shrink to a normal level, and the artificial chordae implanted before will gradually change from a tightened state. Slack, relatively long length, the traction effect on the valve leaflets is correspondingly weakened or disappeared, leading to the risk of mitral valve leaflet prolapse and insufficiency, and then mitral valve regurgitation occurs again. Therefore, after the artificial tendon is implanted for a certain period of time, the length of the implanted artificial tendon needs to be adjusted.

Summary of the invention

The present application provides a chordal control implant, a chordal control device and a chordal control system with simple structure and convenient operation.

In the first aspect, the present application provides a chordal control implant, which is used to adjust the effective length of the artificial chord, including:

A wire locking sleeve, the barrel wall of the wire locking sleeve is provided with a wire locking groove communicating with the inner cavity of the wire locking sleeve, and the wire locking groove extends along the circumferential direction of the wire locking sleeve; At least two rows of a plurality of gear slots arranged in the axial direction are provided on the cylinder wall of the locking sleeve; and

The locking elastic piece is arranged in the inner cavity of the locking sleeve, and the locking elastic piece includes a bearing platform and at least two side wings, and the at least two side wings respectively extend from the bearing platform to at least two rows of the gear positions. Extend on the side of the groove;

When the lock slot hook of the lock wire sleeve takes the artificial chord, the at least two side wings are in a folded state, and the bearing platform pushes the artificial chord along the lock wire sleeve under external force The cylinder moves axially to reduce the effective length of the artificial tendon; when the effective length of the artificial tendon is reduced to the target length, the at least two side wings are deployed to engage at least two The gear slots are arranged so that part of the artificial tendon is folded and limited between the locking sleeve and the bearing platform.

In a second aspect, the present application provides a chordal control device, including the chordal control implant and a transporter, and the transporter includes:

A catheter and a connecting piece connected to the distal end of the catheter, the connecting piece being used to connect the locking sleeve of the chordal control implant;

The control handle is connected to the proximal end of the catheter; and

Pushing assembly, the pushing assembly is arranged in the containing space formed by the inner cavity of the connecting piece, the inner cavity of the catheter and the inner cavity of the control handle, the proximal end of the pushing assembly is connected with the control handle, The distal end of the pushing component makes at least two side wings of the locking elastic piece of the chordal cord control implant in a folded state or an open state, and the pushing component is manipulated by the regulating handle to push the chordal cord The locking elastic piece of the regulating and controlling implant is moved along the axial direction, and the connecting member is separated from the chordal regulating and controlling implant.

In a third aspect, the present application provides a chordal control system, which includes an adjustable bend sheath and the chordal control device. The adjustable bend sheath includes a sheath and a bend adjustment connected to the proximal end of the sheath. The control handle, the bending control handle is used to control the bending of the sheath, the chordal control implant, the connecting piece, and the catheter are movably pierced through the inner cavity of the sheath and the adjustment Bend the inner cavity of the control handle.

The chordal control implant provided in this application is designed to include a locking sleeve and a locking elastic piece. The locking sleeve is used to hook the artificial tendon, and the locking elastic piece gradually enters the locking sleeve. During the process of the tube, the artificial tendon is gradually brought into the locking sleeve to reduce the effective length of the artificial tendon; when the effective length of the artificial tendon is reduced to a suitable length, at least two of the elastic pieces are locked. The two side wings are opened and engaged with the gear slot of the locking sleeve, so that part of the artificial tendon is folded and confined between the locking sleeve and the bearing platform, and this part of the artificial tendon is folded In a "several" shape or an inverted "U" shape, the effective length of the artificial tendon can be fixed after being reduced. In this way, the chord regulating implant realizes the function of adjusting the effective length of the artificial tendon. The chordal control implant provided in the present application has the characteristics of simple structure, simple control operation, reliable control effect, and the like.

The chordal control device and the chordal control system provided in the present application include the above-mentioned chordal control implant and a conveyor. The pusher assembly of the conveyor can make the chordal control implant under the action of the control handle At least two side wings of the locking elastic piece are in a folded state and push the locking elastic piece in the folded state to move along the axial direction of the locking sleeve, so that part of the artificial tendon is folded and confined to the locking sleeve The effective length of the artificial tendon is reduced between the carrier and the carrying platform. When the effective length of the artificial tendon is reduced to a suitable length, the pusher assembly of the conveyor releases at least two side wings of the locking elastic piece to At least two side wings of the locking elastic piece are opened and engaged with the gear slot of the locking sleeve, so that the locking elastic piece is fixed to the locking sleeve, so that the effective length of the artificial tendon is no longer reduced and fixed; The pushing component of the conveyor separates the connecting member from the chordal control implant, so that the chordal control implant is fixed on the artificial tendon. In this way, the chordal control device and the chordal control system realize the adjustment of the effective length of the artificial tendon and fix the tendon control implant on the artificial tendon. The tendon cord control device and tendon cord control system provided in the present application have the characteristics of simple structure, simple control operation, reliable control effect, and the like.

Description of the drawings

In order to explain the technical solutions of the embodiments of the present application more clearly, the following will briefly introduce the drawings needed in the embodiments. Obviously, the drawings in the following description are only some embodiments of the present application. For those of ordinary skill in the art, without creative work, other drawings can be obtained from these drawings.

Fig. 1 is a schematic structural diagram of a chordal control system provided by an embodiment of the present application;

Figure 2 is a schematic structural diagram of an adjustable bending sheath in a straightened state provided by an embodiment of the present application;

Figure 3 is a schematic structural diagram of a chord regulating device provided by an embodiment of the present application;

Fig. 4 is a schematic diagram of the chordal control implant provided by the embodiment of the present application after the implantation is completed;

Fig. 5a is a schematic diagram of a chordal control implant provided in an embodiment of the present application for regulating artificial chordae from a viewing angle;

Fig. 5b is a schematic diagram of a chordal control implant provided by an embodiment of the present application for regulating artificial chordae from another perspective;

Fig. 6 is a schematic diagram of a three-dimensional structure of a locking sleeve in a chordal control implant provided by an embodiment of the present application;

FIG. 7 is a schematic diagram of a three-dimensional structure of a locking elastic piece in a folded state of a chordal cord control implant according to an embodiment of the present application; FIG.

8 is a schematic diagram of a three-dimensional structure of a locking elastic piece in an open state of a chordal cord control implant provided by an embodiment of the present application;

Fig. 9a is a schematic structural diagram of a chordal control implant hooking and taking artificial chordae according to an embodiment of the present application;

Fig. 9b is a schematic cross-sectional structure diagram of Fig. 9a;

FIG. 10a is a schematic structural diagram of a locking elastic piece axially moving forward and bending an artificial tendon cord according to an embodiment of the present application; FIG.

Fig. 10b is a schematic cross-sectional structure diagram of Fig. 10a;

Fig. 11a is a schematic structural diagram of a locking elastic piece engaged with a locking sleeve and locking the effective length of the artificial tendon according to an embodiment of the present application;

Fig. 11b is a schematic cross-sectional structure diagram of Fig. 11a;

Fig. 12a is a schematic structural diagram of a chordal control implant fixed to an artificial chord according to an embodiment of the present application;

Fig. 12b is a schematic cross-sectional structure diagram of Fig. 12a;

FIG. 13 is a perspective exploded schematic diagram of the distal end of a chordal control device provided by an embodiment of the present application;

14 is a perspective exploded schematic view of the proximal end of a chordal control device provided by an embodiment of the present application;

15 is a schematic diagram of the structure of the handle in the chord regulating device provided by the embodiment of the present application;

16 is a schematic structural diagram of a push tube in the chordal control device provided by an embodiment of the present application;

FIG. 17 is a schematic diagram of the structure of the adjustable bending sheath in the bending state of the chordal control device provided by the embodiment of the present application;

FIG. 18 is a schematic partial cross-sectional structure diagram of a bending control handle of an adjustable bending sheath provided by an embodiment of the present application.

Detailed ways

The technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. The embodiments listed in this application can be appropriately combined with each other.

For ease of description, the end of all structures in this application that is farther from the operator is defined as the distal end of the structure, and the end of all structures in this application that is closer to the operator is defined as the proximal end of the structure.

Please refer to FIGS. 1 to 4, the present application provides a chordal control system 100, which includes an adjustable bending sheath 20 and a chordal control device 30. The chordal control device 30 includes a chordal control implant 10 and a conveyor 40.

As shown in Fig. 4, the chordal control implant 10 is implanted into the ventricle to make part of the artificial tendons 200 fold in the shape of an inverted "U" or "several" in the chordal control implant 10, The effective length of the artificial chord 200 is shortened, and the effective length of the artificial chord 200 is adjusted by adjusting the folding length of the artificial chord 200 in the chord regulating implant 10. The effective length of a suitable artificial chord 200 should be the length required for the artificial chord to pull the valve leaflets so that the valve leaflets can be closed normally.

Please refer to FIG. 2, the adjustable bending sheath 20 includes a sheath tube 21 and a bending control handle 22. The sheath 21 is installed at the distal end of the bending control handle 22. The adjustable curved sheath 20 is used to provide a conductive path from the outside to the ventricle. Please refer to FIG. 1, the transporter 40 transports the chordal control implant 10 to the artificial chord 200 through the conduction path opened by the adjustable curved sheath 20.

Please refer to FIG. 3, the conveyor 40 includes a catheter 41, a regulating handle 42, a connecting piece 43 (see FIG. 13), and a pushing component 44 (see FIG. 14). The catheter 41 is installed at the distal end of the control handle 42. The connecting piece 43 is connected to the distal end of the catheter 41. The chordal control implant 10 is detachably connected to the distal end of the connecting member 43. The pushing component 44 penetrates through the connecting piece 43, the pipe 41 and the control handle 42.

The conveyor 40 is used to transport the chordal control implant 10 and actuate the chordal control implant 10 to adjust the folded length of the artificial tendon 200 in the chordal control implant 10, so that the chordal control implant 10 can be adjusted. 10 Adjust the effective length of the artificial tendon 200 to an appropriate size.

Please refer to FIGS. 1 to 3 together, the catheter 41 of the conveyor 40 is movably installed in the sheath 21 and the bending control handle 22, and passes through the distal end of the sheath 21. The distal end of the sheath tube 21 can be adjusted to be bent, and can be rotated correspondingly with the twisting of the bending control handle 22. The catheter 41 is coaxial with the sheath tube 21, and can be rotated inside the sheath tube 21 to control the chordal cord to adjust the direction of the opening of the locking groove 111 on the implant 10 for hooking the artificial chord 200, which is conducive to locking the thread. The groove 111 hooks the artificial tendon 200.

In one scenario, referring to FIGS. 1 to 4, the sheath tube 21 passes through the femoral artery approach, turns over the aortic arch, and enters the left ventricle to provide a passage for the transporter 40. After the catheter 41 of the conveyor 40 reaches the left ventricle through the sheath 21, the chordal cord regulating implant 10 arranged at the distal end of the catheter 41 of the conveyor 40 extends out of the distal end of the sheath 21. By adjusting the bending angle of the distal end of the sheath tube 21 and twisting the direction, the chordal cord regulating implant 10 can accurately hook the artificial chordal cord 200. Observe the therapeutic effect of mitral regurgitation based on ultrasound images and DSA images, and adjust the contraction and control of the artificial chordae 200 by the chordal control implant 10 appropriately. When the effective length of the artificial chord 200 is adjusted to the length required for the artificial chord to pull the valve leaflets normally closed, by controlling the regulating handle 42 at the proximal end of the conveyor 40, the chords can regulate the implant 10 and the conveyor. 40 relief. The chordal control implant 10 is fixed on the artificial chord 200 so that the length of the artificial chord 200 is shortened, and is placed in the left ventricle as a part of the artificial chord 200. Finally, the catheter 41 and sheath 21 of the conveyor 40 are withdrawn, and the contraction control of the artificial chord 200 is completed.

The embodiments of the present application illustrate the specific structure of the chordal control implant 10 with reference to the accompanying drawings. For ease of description, it is defined that the axial direction of the chordal control implant 10 is the Y-axis direction, the direction of the distal end is the positive direction of the Y-axis, and the direction of the proximal end is the reverse of the Y-axis.

Please refer to FIGS. 5 a and 5 b, the chordal control implant 10 includes a locking sleeve 11 and a locking elastic piece 12 that can be engaged in the locking sleeve 11.

Please refer to FIG. 6, the locking sleeve 11 has a hollow inner cavity 110. The cylinder wall of the locking sleeve 11 is provided with a locking groove 111 communicating with the inner cavity of the locking sleeve 11. In other words, the cylinder wall of the locking sleeve 11 is provided with a locking groove 111 that penetrates at least part of the cylinder wall in the circumferential direction.

Specifically, the locking sleeve 11 is usually made of a rigid material with biocompatibility, such as SUS316L stainless steel or PP material. The shape of the locking sleeve 11 includes, but is not limited to, a cylinder, and can also adopt an elliptical or square cylindrical structure. Specifically, the wire-locking groove 111 is provided in the middle of the wire-locking sleeve 11, and its structure is an arc-shaped open groove. The artificial chord 200 can be hooked into the locking sleeve 11 to facilitate subsequent adjustment of the artificial chord 200. Because the wire-locking groove 111 is provided on the cylinder wall along the circumferential direction. It is easy to visualize under ultrasound whether from the lateral direction or the axial direction, and it is easy to hook the artificial chord 200.

Please refer to FIG. 6, the wire locking groove 111 extends along the circumferential direction of the wire locking sleeve 11. Specifically, the intersecting surface of the wire locking groove 111 and the cylinder wall of the wire locking sleeve 11 may be perpendicular or inclined with respect to the axis of the wire locking sleeve 11. In other words, the extending direction of the wire locking groove 111 may be perpendicular to the axial direction of the wire locking sleeve 11; or, the extending direction of the wire locking groove 111 may intersect but not perpendicular to the axial direction of the wire locking sleeve 11 . Optionally, the circumferential length of the thread locking groove 111 occupies more than 1/2 of the circumference of the thread locking sleeve 11, so that the thread locking groove 111 has a higher success rate for hooking the artificial tendon 200, and the thread locking groove 111 111 can maintain the state of hooking and removing the artificial tendon 200 more stably, and the artificial tendon 200 is not easily detached from the locking groove 111.

Please refer to FIG. 6, the cylinder wall of the locking sleeve 11 is provided with at least two rows and a plurality of gear slots 112 arranged in the axial direction. In this embodiment, the gear slot 112 penetrates the wire locking sleeve 11 and communicates with the outer cavity of the wire locking sleeve 11 and the inner cavity of the wire locking sleeve 11. In other embodiments, the gear slot 112 may not penetrate the locking sleeve 11 to increase the structural strength of the locking sleeve 11.

There are multiple gear slots 112 in each row. In this embodiment, the number of gear slots 112 in a row is 4. In other embodiments, the number of gear slots 112 may also be 1, 2, 3, 5, etc. The multiple gear slots 112 in each row can be evenly arranged along the axial direction. That is, the spacing between every two adjacent gear slots 112 is equal. The distance between two adjacent gear slots 112 may range from 1-2 mm. The gear slots 112 in different positions represent different locking depths. The gear slot 112 closest to the distal end corresponds to the maximum locking depth. The greater the shortened length of the artificial tendon 200, the greater the adjustment range.

In this embodiment, the number of rows of the gear slot 112 is two rows. In other embodiments, the number of rows of the gear slot 112 may also be one row, three rows, four rows, and so on. This application does not specifically limit the specific structure of the gear slot 112. In other words, the shape of the gear slot 112 may be a circular slot, a square slot, an elliptical slot, a triangular slot, and so on.

Please refer to FIG. 5b and FIG. 7, the locking elastic piece 12 can movably pass 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 respectively extending from the bearing platform 121 to the side where at least two rows of the gear slots 112 are located. The at least two side wings 122 are both outwardly and obliquely extended toward the proximal direction of the locking sleeve 11 relative to the carrying platform 121. The gear slots 112 in the same row are evenly distributed or non-uniformly distributed along the axial direction.

Wherein, the number of rows of the gear slot 112 may be greater than or equal to the number of side wings 122. Optionally, the number of rows of the gear slot 112 is equal to the number of side wings 122. Each side wing 122 respectively extends toward different gear slots 112.

In this embodiment, the gear slot 112 is provided between the wire locking slot 111 and the proximal end M of the wire locking sleeve 11 (please refer to FIG. 6). Before the locking elastic piece 12 pushes the artificial tendon 200, the bearing platform 121 is located between the locking groove 111 and the proximal end M of the locking sleeve 11. At least two side wings 122 are bent relative to the carrying platform 121. At least two side wings 122 extend along the proximal end M of the locking sleeve 11.

In this embodiment, referring to FIG. 7, the bearing platform 121 is a plate perpendicular to the Y-axis direction, the number of rows of the gear slot 112 is two, and the number of side wings 122 is two and is relatively called as an example. Description. Wherein, the carrying platform 121 extends along the X-axis direction. The two side wings 122 are symmetrically arranged on both sides of the carrying platform 121.

Please refer to FIGS. 7 and 8. FIGS. 7 and 8 are schematic diagrams of the locking elastic piece 12 in the folded state and the opened state in this embodiment, respectively.

At least two side wings 122 can be in a folded state or an open state under the action of external force. Specifically, the locking elastic piece 12 is a metal piece with resilience performance after being shaped at high temperature, which can expand by itself without applying external force. Among them, the folded state is a state when at least two side wings 122 are close to each other. In this embodiment, at least two side wings 122 are gathered in the push tube of the conveyor 40 (see the following description). When the at least two side wings 122 are separated from the push tube of the conveyor 40, the at least two side wings 122 will expand under their own deformation recovery force until the at least two side wings 122 abut against the inner wall of the locking sleeve 11.

Please refer to Figure 7, Figure 9a and Figure 9b, when the at least two side wings 122 are in the folded state, because the at least two side wings 122 do not abut the inner wall of the locking sleeve 11, the locking elastic piece 12 will not be affected. Due to the obstruction of the locking sleeve 11, the locking elastic piece 12 can move through the inner cavity of the locking sleeve 11. When the locking groove 111 of the locking sleeve 11 is hooked to the artificial chord 200, the at least two side wings 122 are in a folded state, and the locking elastic piece 12 is pushed to move toward the distal end in the axial direction. The bearing platform 121 pushes the artificial chord 200 to move toward the distal end along the axial direction of the locking sleeve 11 under external force, so that the length of the artificial chord 200 folded in the chord regulating implant 10 is increased. Large, so that the effective length of the artificial chord 200 is reduced.

Referring to Figures 8 and 5a, when the effective length of the artificial chord 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 deployed under their own restoring force to respectively It is engaged with the gear slot 112, so that part of the artificial chord 200 is folded and limited between the locking sleeve 11 and the carrying platform 121, so that the chord regulating implant 10 is more effective for artificial chords. The shortened length of the chord 200 is locked.

The chordal control implant 10 is designed to include a locking sleeve 11 and a locking elastic piece 12. The locking sleeve 11 is used to hook the artificial tendon 200, and the locking elastic piece 12 is gradually entering the locking sleeve 11 The artificial tendon 200 is also gradually brought into the locking sleeve 11 to reduce the effective length of the artificial tendon 200; when the effective length of the artificial tendon 200 is reduced to a suitable length, at least the elastic piece 12 is locked The two side wings 122 are opened and engaged with the gear slot 112 of the locking sleeve 11, so that the locking elastic piece 12 is fixed to the locking sleeve 11, so that the effective length of the artificial tendon 200 is no longer reduced and fixed; In this way, the chordal cord regulating implant 10 realizes the function of adjusting the effective length of the artificial chordal 200. The chordal control implant 10 provided by the present application has the characteristics of simple structure, simple control operation, reliable control effect, and the like.

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

Specifically, the barbs 123 extend outwardly and toward the proximal end relative to the side wings 122. Optionally, the angle between the barbs 123 and the side wings 122 ranges from 10° to 45°.

In this embodiment, each side wing 122 is provided with two sets of barbs 123. Each group of barbs 123 includes two barbs 123 arranged side by side along the Z-axis direction (see FIG. 7) to increase the engagement strength of the barbs 123 with the gear slot 112. It is understandable that the gear slots 112 corresponding to the side wings 122 can be arranged in four rows and two columns along the axial direction, and the two gear slots 112 in each row engage with the two barbs 123 in each group. The gear slots 112 in different rows correspond to different locking depths. The gear slot 112 closest to the distal end corresponds to the maximum locking depth, and the greater the shortened length of the artificial tendon 200, the greater the adjustment range. Of course, the number of groups of barbs 123, the number of barbs 123 in each group, and the number of rows and columns of the gear slot 112 in this embodiment are all examples. Quantity adjustments should also fall within the scope of protection of this application.

Please refer to FIG. 6, the cylinder wall of the locking sleeve 11 is also provided with at least one guide groove 113 extending in the axial direction. The guide groove 113 may or may not penetrate the cylinder wall of the locking sleeve 11. In this embodiment, the guide groove 113 penetrates the cylinder wall of the locking sleeve 11. In this embodiment, a pair of oppositely disposed guide grooves 113 are taken as an example for description, which will not be repeated in the following.

Referring to FIGS. 7 and 8, the locking elastic piece 12 further includes at least one positioning rod 124 extending radially outward from the carrying platform 121. The positioning rod 124 is slidably inserted into the guide groove 113 to guide the locking elastic piece 12 to move in the axial direction in the locking sleeve 11. In this embodiment, a pair of opposed positioning rods 124 are taken as an example for description, and details will not be repeated in the following. A pair of positioning rods 124 extend away from the carrier 121 in the X-axis direction. Referring to FIG. 5a, a pair of positioning rods 124 are respectively disposed in a pair of guide grooves 113, so that the wire locking sleeve 11 and the locking elastic piece 12 are connected to form a whole.

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

When the locking groove 111 of the locking sleeve 11 is hooked to the artificial tendon 200 or before the artificial tendon 200 is hooked, the pair of positioning rods 124 abut against the pair of guide grooves, respectively The proximal end of 113. The proximal end of the guide groove 113 is flush with the proximal end of the wire locking groove 111; or, the proximal end of the guide groove 113 is provided at the proximal end of the wire locking groove 111 and the wire locking sleeve 11 Between the proximal end M of the locking slot 111, so that the bearing platform 121 is arranged between the locking groove 111 and the proximal end M of the locking sleeve 11, and the bearing platform 121 avoids the locking slot 111 to avoid It interferes with the artificial tendon 200 entering the lock slot 111.

In this embodiment, referring to FIG. 6, a part of one guide groove 113 of the pair of guide grooves 113 overlaps with the wire locking groove 111, and the other part of one guide groove 113 of the pair of guide grooves 113 The inner wall of the wire locking groove 111 extends axially toward the distal end N of the wire locking sleeve 11, so that the space of the guide groove 113 and the wire locking groove 111 are reused, and the guide groove 113 is also close to The end is the proximal end of the locking groove 111, and the carrying platform 121 will not interfere with the entry of the artificial tendon 200 into the locking groove 111; the other guide groove 113 of the pair of guide grooves 113 is in the radial direction. It is arranged opposite to the locking groove 111 in the direction.

After the thread locking groove 111 of the thread locking sleeve 11 is hooked to the artificial tendon 200, under external force, the pair of positioning rods 124 of the locking elastic piece 12 slide along the pair of guide grooves 113 to ensure the lock The elastic stopper 12 moves in the axial direction when being pushed. During this process, the pair of side wings 122 of the elastic locking plate 12 always remain in a folded state, and the bearing platform 121 of the elastic locking plate 12 abuts against the artificial tendon 200 and The artificial chord 200 is pushed to move toward the distal end N of the locking sleeve 11, so that the length of the artificial chord 200 entering the locking sleeve 11 gradually increases, and the effective length of the artificial chord 200 gradually decreases. The cooperation of the locking sleeve 11 and the locking elastic piece 12 locks a part of the artificial chord 200 into a "several" shape or an inverted "U" shape to shorten the effective length of the artificial chord 200. When the effective length of the artificial tendon 200 reaches a suitable length, the locking elastic piece 12 is pushed to a proper position in the locking sleeve 11 in the axial direction, and the pair of side wings 122 of the locking elastic piece 12 are released and opened. The barbs 123 on the pair of side wings 122 are inserted into the corresponding gear slot 112 by elastic force to fix their axial position, so that the locking elastic piece 12 is fixed in the locking sleeve 11 to shorten the artificial tendon 200 The length is locked, so that the artificial chord 200 maintains the suitable effective length.

Please refer to FIG. 6, the cylinder wall of the locking sleeve 11 is provided with a pair of first connecting holes 114 arranged oppositely and radially symmetrical. The first connecting hole 114 may be provided between two oppositely disposed gear slots 112. The first connection hole 114 is used to connect to the conveyor 40 so that the chordal control implant 10 is connected to the conveyor 40.

With reference to Figures 9a to 12b, the process of the chordae regulating implant 10 acting on the artificial chord 200 is divided into the following four stages:

In the first stage, referring to FIGS. 9a and 9b, the artificial tendon 200 is hooked by the locking groove 111 of the locking sleeve 11 and enters the locking groove 111.

In the second stage, referring to FIGS. 10a and 10b, the locking elastic piece 12 is pushed to move toward the distal end along the axial direction. The wire locking groove 111 is pushed toward the distal end by the supporting platform 121 of the locking elastic sheet 12 in the contracted state. The artificial tendon 200 is then received into the locking sleeve 11 and contracted in a "several" shape.

In the third stage, please refer to Figures 11a and 11b. When the stroke of the artificial chord 200 is reduced to an appropriate length, that is, when the reflux condition has just completely disappeared, the locking elastic piece 12 is stopped from moving axially, and then the lock The axially symmetrical side wings 122 of the anti-elastic piece 12 are self-expanding and spring apart. The barbs 123 on the side wing 122 are inserted into the gear slot 112 of the locking sleeve 11 to fix the locking elastic piece 12 in a set position. The gear slots 112 are arranged at equal intervals along the axial direction. When the locking elastic piece 12 is released at different positions, the locking position thereof is also different. The locking depth can be determined according to the length of the artificial chord 200 to be shortened. If it is found after the locking elastic piece 12 is released that the artificial chord 200 still needs to be shortened, the carrying platform 121 of the locking elastic piece 12 can be pushed to the distal end. During this process, the barb 123 can be detached from one gear slot 112 and retracted until the pushing stops, and then re-inserted in another gear slot 112 on the far side, thereby adjusting the artificial chord 200 to the desired length . After the adjustment is completed, due to the action of the barb 123, the carrying platform 121 will not move toward the proximal end, so that the effective length of the shortened artificial chord 200 will not change.

In the fourth stage, referring to FIGS. 12a and 12b, the locking sleeve 11 is separated from the conveyor 40.

The structure of the conveyor 40 will be exemplified below in conjunction with the drawings.

Please refer to FIG. 3, a chord regulating device 30 provided by an embodiment of the present application. The chordal control device 30 includes a conveyor 40 and the chordal control implant 10 described in any one of the above embodiments.

Please refer to FIGS. 13 and 14, the conveyor 40 includes a catheter 41, a connecting piece 43, a regulating handle 42 and a pushing component 44.

Please refer to FIG. 13, the connecting member 43 is connected to the distal end of the catheter 41. The connecting member 43 is used to connect with the locking sleeve 11 of the chordal control implant 10. It can be understood that the connecting member 43 and the chordal control implant 10 are detachably connected.

The tube body structure of the catheter 41 is a woven mesh structure, which is mainly formed by hot-melt composite molding of polymer materials. The duct 41 can be bent. Please refer to FIG. 1, when the catheter 41 is set in the sheath tube 21 of the adjustable bend sheath 20, the catheter 41 can bend with the bending of the sheath tube 21 to regulate the implantation of the chordae connected by the connector 43. The incoming piece 10 is transported to the position where the artificial tendon 200 is located.

Please refer to FIG. 14, the control handle 42 is connected to the proximal end of the catheter 41.

Please refer to FIGS. 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 regulating handle 42. The pushing assembly 44 is coaxially arranged with the pipe 41.

Please refer to FIG. 13 and FIG. 14, the proximal end of the pushing assembly 44 extends out of the proximal end of the catheter 41 and is connected to the regulating handle 42. The adjusting handle 42 can control the axial displacement of the pushing assembly 44. The distal end of the pushing assembly 44 is located in the inner cavity of the connecting member 43 and is used to push the locking elastic piece 12 of the chordal control implant 10.

The pushing component 44 causes the at least two side wings 122 of the locking elastic piece 12 of the chordal cord control implant 10 to be in a closed state or an open state under the action of the control handle 42. The pushing assembly is controlled by the control handle to push the locking elastic piece 12 of the chordal control implant 10 to move in the axial direction, and make the connecting member 43 and the chordal control implant 10 move in the axial direction. The locking sleeve 11 is separated.

By arranging the conduit 41, the connecting piece 43, and the regulating handle 42 in the conveyor 40 that communicate with each other in the inner cavity, and setting the pushing assembly 44 in the inner cavity of the conduit 41, the connecting piece 43 and the regulating handle 42, the pushing assembly 44 is in the place. The control handle 42 can make the at least two side wings 122 of the locking elastic piece 12 of the chordal control implant 10 in a folded state and push the locking elastic piece 12 in the folded state along the axis of the locking sleeve 11 Move to make part of the artificial tendon 200 folded and confined between the locking sleeve 11 and the bearing platform 121, thereby reducing the effective length of the artificial tendon 200, when the artificial tendon 200 When the effective length is reduced to a suitable length, the pushing assembly 44 releases the at least two side wings 122 of the locking elastic piece 12, so that the at least two side wings 122 of the locking elastic piece 12 are opened and engaged with the locking sleeve 11 The gear slot 112 is used to fix the locking elastic piece 12 to the locking sleeve 11, so that the effective length of the artificial tendon 200 is no longer reduced and locked; the connecting member 43 can be detachably connected to the tendon regulating implant 10, In order to realize the control and release of the chordal control implant 10, so that the chordal control implant 10 is fixed on the artificial tendon 200. In this way, the chordal control device 30 realizes the adjustment of the effective length of the artificial chord 200 and fixes the chordal control implant 10 to the artificial chord 200. The chord regulating device 30 provided by the present application has the characteristics of simple structure, simple regulating operation, reliable regulating effect, and the like.

Please refer to FIG. 14, the control handle 42 includes a control knob 421 and a control handle housing 422. The control knob 421 is provided at the distal end of the control handle 42. The catheter 41 passes through the manipulation knob 421 from the proximal end of the manipulation knob 421. The distal end of the control handle housing 422 is connected to the proximal end of the control knob 421. The manipulation knob 421 can rotate relative to the control handle housing 422 around the axial direction of the catheter 41.

Please refer to FIG. 13 and FIG. 14, the pushing assembly 44 includes a push tube base 441 and a push tube 442 arranged coaxially with the push tube base 441. The push tube base 441 is provided in the control handle housing 422.

Please refer to FIG. 15, the distal end of the push tube holder 441 is threaded. The distal end of the push tube socket 441 is threadedly connected to the proximal end of the manipulation knob 421. The push tube 442 is movably installed in the duct 41. The distal end of the push tube 442 is set in the connecting piece 43, the push tube 442 is movably inserted in the lumen of the connecting piece 43, the lumen of the catheter 41 and the lumen of the push tube seat 441, and the proximal end of the push tube 442 is connected to the push tube. The proximal end of the seat 441 is fixedly connected.

When the control knob 421 rotates in one direction, the push tube base 441 can drive the push tube 442 to move toward the distal end gradually in the axial direction; when the control knob 421 rotates in the opposite direction, the push tube base 441 The push tube 442 can be driven to gradually move toward the proximal end along the axial direction.

Referring to FIG. 9b, the distal end of the push tube 442 is used to constrain the proximal ends of the at least two side wings 122 of the locking elastic piece 12, so that the at least two side wings 122 of the locking elastic piece 12 are in a closed state. Specifically, the push tube 442 has a circular tube shape. The at least two side wings 122 of the locking elastic piece 12 are gathered in the inner cavity space of the distal end of the push tube 442 so that the at least two side wings 122 of the locking elastic piece 12 are in a folded state.

When the push tube seat 441 drives the push tube 442 toward the proximal end in the axial direction under the action of the control knob 421, the push tube 442 gradually separates from the two side wings 122 of the locking spring 12 After the two side wings 122 of the locking elastic piece 12 are no longer subjected to the restraining force of the push tube 442, they are deployed under their own deformation restoring force and engaged with at least two rows of the gear slots 112. In this way, the position of the locking elastic piece 12 in the locking sleeve 11 is fixed, and the chordal cord regulating implant 10 locks the folded length of the artificial chord 200.

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

In the initial state, referring to FIG. 9b, the two side wings 122 of the proximal end of the locking elastic piece 12 are contracted in the inner cavity of the push tube 442 and abutted by the distal end of the push rod 443. The locking elastic piece 12 and the push tube 442 are jointly placed in the inner cavity of the connecting piece 43 at the distal end of the catheter 41.

Please refer to FIG. 16, a small distal area (about 10-20 mm) of the push tube 442 is a rigid tube 4421. The main area of the push tube 442 is a flexible tube 4422 with certain support and compliance. The flexible tube 4422 can usually be made of a stainless steel serpentine tube to adapt to the curved blood vessel approach through the catheter 41. The push rod 443 is a metal rod with elasticity and support. Nitinol materials are preferred. The distal end of the push rod 443 and the locking elastic piece 12 are tightened in the hard tube 4421 at the distal end of the push tube 442. The push rod 443 abuts against the locking elastic piece 12 and provides support for the locking elastic piece 12.

Please refer to FIGS. 14 and 15, the proximal end of the push rod 443 extends out of the proximal end of the push tube base 441 and is fixedly connected to the push rod base 444. The push rod seat 444 is provided in the control handle housing 422. The distal end of the push rod seat 444 is opposite to the proximal end of the push tube seat 441. The distal end of the push rod seat 444 and the proximal end of the push tube seat 441 are connected by an elastic member 445.

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

When the control knob 421 rotates in one direction, the push tube seat 441 drives the push tube 442 to move axially toward the distal end under the action of the control knob 421, and the push tube seat 441 stretches elastically. The member 445 drives the elastic member 445 to move toward the distal end, and the elastic member 445 drives the push rod seat 444 and the push rod 443 to move toward the distal end in the axial direction under the action of the push tube seat 441. In this way, both the push rod 443 and the push tube 442 can push the locking elastic piece 12 in the collapsed state to move toward the distal end in the axial direction, so that the locking elastic piece 12 shortens the effective length of the artificial chord 200.

Please refer to FIGS. 14 and 15, the control handle 42 further includes a stop component 423 disposed on the side of the push rod seat 444 away from the push rod 443. The stop assembly 423 includes a stop valve 45 and a pressing button 46 connected to the stop valve 45. The stop valve 45 is arranged opposite to the proximal end of the push rod seat 444 in the control handle housing 422. There is no connection between the stop valve 45 and the push rod seat 444. The crimping button 46 is installed on the control handle housing 422 and is used to control the axial movement or stop of the stop valve 45 so as to abut against the push rod seat 444 or be separated from the push rod seat 444.

Please refer to FIG. 14 and FIG. 15, the number of the crimping buttons 46 is two. The two crimping buttons 46 are symmetrically arranged on opposite sides of the stop valve 45. The crimping button 46 includes a limiting post 461, a compression spring 462, an engaging member 463 and a pressing member 464. The engaging member 463 has first teeth 465. The inner surface of the control handle housing 422 has a second tooth 424 engaged with the first tooth 465. The limiting post 461 is connected between the engaging member 463 and the stop valve 45. The limiting post 461 is embedded in the inner side of the crimping button 46 to be fixed. The compression spring 462 is sleeved on the limiting post 461 and compressed between the engaging member 463 and the stop valve 45. One end of the pressing member 464 is arranged outside the control handle housing 422. The other end of the pressing member 464 penetrates the control handle housing 422 and is connected to the engaging member 463. The compression spring 462 is a compression spring. In a normal state, the compression spring 462 abuts the pressing member 464 so that the first tooth 465 inside the pressing member 464 meshes with the second tooth 424 inside the control handle housing 422, so that the shaft of the stop valve 45 The position is relatively fixed. When the pressing pieces 464 on both sides are pressed, the first teeth 465 inside the pressing pieces 464 can be separated from the second teeth 424 inside the regulating handle housing 422, and the stop valve 45 can be displaced in the axial direction.

When the pressing member 464 is pressed, the compression spring 462 is compressed, the pressing member 464 moves toward the stop valve 45, the first tooth 465 of the engaging member 463 and the first tooth 465 of the inner surface of the control handle housing 422 are compressed. The two teeth 424 are separated. The pressing member 464 moves axially toward the distal end to drive the stop valve 45 to move until the stop valve 45 abuts against the proximal end of the push rod seat 444. When the pressing member 464 is released, the pressing member 464 is no longer subject to the pressing force, and 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 tooth 465 of the engaging member 463 It engages with the second teeth 424 on the inner surface of the control handle housing 422 to lock the position of the stop valve 45 and the axial position of the push rod 443.

With reference to Figures 9b and 10b, when the artificial tendon 200 is hooked by the thread locking groove 111 of the thread locking sleeve 11 and enters the thread locking groove 111, the manipulation knob 421 rotates in one direction, and the push tube seat 441 Under the action of the control knob 421, the push tube 442 is driven to move toward the distal end in the axial direction. The push tube seat 441 stretches the elastic member 445 and drives the elastic member 445 to move toward the distal end. 445 drives the push rod seat 444 and the push rod 443 to move toward the distal end in the axial direction under the action of the push tube seat 441, and the push rod 443 and the push tube 442 move toward the distal end together and push the locking spring 12 Moving toward the distal end, the bearing platform 121 of the locking elastic sheet 12 pushes the artificial tendon 200 to move toward the distal end, and the effective length of the artificial tendon 200 is gradually shortened.

With reference to FIG. 15, when the effective length of the artificial tendon 200 is reduced to the target length, the pressing member 464 is pressed, and the first tooth 465 of the engaging member 463 is connected to the control handle housing 422. The second teeth 424 on the inner surface are separated, and the pressing member 464 moves axially toward the distal end to drive the stop valve 45 to move until the stop valve 45 abuts the push rod seat 444. The state where the effective length of the artificial chordae 200 is the target length is that the artificial chordae 200 has a moderate traction force between the valve leaflets and the ventricular wall, and the mitral valve regurgitation disappears or reaches the slightest state.

With reference to Figure 11b, when the stop valve 45 abuts the push rod seat 444, and the push tube seat 441 drives the push tube 442 to move axially toward the proximal end under the action of the control knob 421 At this time, the push rod 443 keeps abutting against the proximal ends of the at least two side 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, and the at least two side wings 122 of the locking elastic piece 12 lose the push tube The restraint force of 442 opens, and at least two side wings 122 of the locking elastic piece 12 are engaged with the corresponding gear slots 112, so that the chordal cord control implant 10 locks the effective length of the artificial chord 200.

With reference to FIGS. 12b and 13 in combination, a pair of second connecting holes 431 communicating with the inner cavity of the connecting member 43 are provided on the outer peripheral surface of the distal end of the connecting member 43.

With reference to FIGS. 9b and 12b in combination, the conveyor 40 further includes a pair of connecting elastic pieces 47 arranged oppositely.

With reference to FIG. 12 b, the proximal end of the connecting elastic piece 47 is engaged with the wall surface 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 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 by the groove 432. Connect to the proximal end of the connecting piece 43. The proximal end of the connecting elastic piece 47 is fixed in the slot 432 of the proximal end of the connecting piece 43.

The material of the connecting elastic piece 47 is preferably a metal elastic piece (such as nickel-titanium). The proximal end of the connecting elastic piece 47 and the proximal end of the connecting piece 43 can be connected by laser welding; the material of the connecting elastic piece 47 can also be plastic Shrapnel, plastic shrapnel can be connected to the proximal end of the connecting shrapnel 47 and the proximal end of the connecting piece 43 by ultrasonic welding.

With reference to FIG. 9b, the middle part of the connecting elastic piece 47 abuts against the outer peripheral surface of the push tube 442. A pair of connecting elastic pieces 47 are respectively symmetrically arranged on opposite sides of the outer circumferential surface of the push tube 442 so as to abut against the distal end of the push tube 442.

With reference to Fig. 9b, the distal end of the connecting elastic piece 47 is an inverted buckle structure. Wherein, the distal end of the connecting elastic piece 47 extends outwardly toward the radial direction of the connecting piece 43. The distal end of the connecting elastic piece 47 movably passes through the second connecting hole 431 of the connecting member 43. In the free state, the distal end of the connecting elastic piece 47 is retracted in the connecting piece 43. When the distal end of the push tube 442 passes through the gap between the pair of connecting elastic pieces 47, the pair of connecting elastic pieces 47 are respectively expanded outward, and the middle part of the connecting elastic piece 47 is affected by the diameter of the push tube 442 toward the connecting piece 43. Force outwards.

With reference to FIG. 9 b, the distal end of the connecting elastic piece 47 is offset toward the second connecting hole 431 on the connecting member 43 and penetrates the second connecting hole 431. When the outer peripheral surface of the push tube 442 pushes the connecting elastic piece 47, the connecting piece 43 is butted with the locking sleeve 11 and the second connecting hole 431 is aligned with the first connecting hole 114 on the locking sleeve 11, the connection The distal end of the elastic piece 47 can be simultaneously engaged with 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 to the wire-locking sleeve 11, so that The locking sleeve 11 and the conveyor 40 are locked together. In this way, it is convenient for the subsequent push tube 442 and push rod 443 to push the locking elastic piece 12 to move, and the locking elastic piece 12 can move relative to the locking sleeve 11, so that the effective length of the artificial tendon 200 gradually enters the lock along with the locking elastic piece 12 The wire sleeve 11 gradually decreases.

When at least two side wings 122 of the chordal control implant 10 are respectively engaged with at least two rows of the gear slots 112, the push tube 442 and the push rod 443 act on the control knob 421 The lower part moves toward the proximal end in the axial direction to withdraw from between the pair of connecting elastic pieces 47, and is separated from the pair of connecting elastic pieces 47. When the push tube 442 and the push rod 443 move toward the proximal end in the axial direction to separate from the connecting elastic piece 47, a pair of the connecting elastic pieces 47 loses the abutting force of the push tube 442, and the distal end of the connecting elastic piece 47 The ends all move closer to the center of the inner cavity of the connecting piece 43 under their own deformation and restoring force. The distal end of the connecting elastic piece 47 is moved out of the first connecting hole 114 and the second connecting hole 431 to separate the connecting piece 43 from the locking sleeve 11 to release the connecting piece 43 from The chordal cord regulates the locking of the implant 10, and the chordal cord regulates implant 10 is released from the distal end of the connecting piece 43 and fixed to the artificial chord 200.

The operation steps of the chordal control device 30 are as follows:

Please refer to FIGS. 9b and 14. In the first stage, the chordal control implant 10 is connected to the connecting member 43 of the conveyor 40. The distal ends of the pair of connecting elastic pieces 47 are all clamped into the locking sleeve 11 of the chordal cord control implant 10 and the connecting piece 43 of the conveyor 40. The middle part of the pair of connecting elastic pieces 47 abuts against both sides of the outer peripheral surface of the distal end of the push tube 442 symmetrically. The proximal end of the locking elastic piece 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 elastic piece 12 in the push tube 442.

By manipulating the adjustable bend sheath 20, the distal end of the adjustable bend sheath 20 is arranged near the artificial tendon cord 200, and the steering of the adjustable bend sheath 20 is adjusted so that part of the artificial tendon cord 200 passes through the tendon control implant 10的锁线槽111。 The lock slot 111. Properly adjust the position of the catheter 41 to make the artificial chord 200 in a relatively loose state.

Please refer to Figure 10a, Figure 10b and Figure 14. In the second stage, the control knob 421 is rotated. The control knob 421 drives the push tube holder 441 and the push tube 442 to move toward the distal end, and the push tube holder 441 drives the push rod 443 to synchronize through the elastic member 445. Moving toward the distal end, the push tube 442 and the push rod 443 push the locking elastic piece 12 together to push the artificial tendon 200 to move axially toward the distal end. The artificial tendon 200 is in the shape of a "several" in the locking sleeve 11. Observe the ultrasound image and the DSA image to determine whether the locking elastic piece 12 is properly contracted to the artificial chord 200 to determine whether to continue to adjust the locking depth of the locking elastic piece 12.

Please refer to Figures 14 and 15, if the mitral valve regurgitation disappears, and it is determined that the degree of contraction of the artificial chord 200 meets the requirements. When the effective length of the artificial chord 200 is a suitable length, press the pressing member 464 of the crimping button 46, the first tooth 465 of the engaging member 463 and the second tooth 465 of the inner surface of the control handle housing 422 The teeth 424 are separated, and the pressing member 464 moves toward the distal end in the axial direction to drive the stop valve 45 to move until the stop valve 45 abuts on the push rod seat 444 to loosen the pressure contact The pressing member 464 of the button 46, the first tooth 465 of the engaging member 463 meshes with the second tooth 424 on the inner surface of the control handle housing 422, and the axial position of the stop valve 45 is fixed, To lock the axial position of the push rod 443.

Please refer to Figure 11a, Figure 11b and Figure 14. In the third stage, the control knob 421 is reversely rotated. The control knob 421 drives the push tube base 441 and the push tube 442 to move toward the proximal end, but the push tube 442 still supports a pair of connecting elastic pieces 47 , The push rod 443 will not move due to the blocking of the stop valve 45, and the elastic member 445 is compressed. The proximal end of the locking elastic piece 12 will not move 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 elastic piece 12, and the pair of side wings 122 of the locking elastic piece 12 gradually move away from the push tube 442. Extend and release the distal end until fully released. When the locking elastic piece 12 is completely released, the axially symmetrical side wing 122 of the locking elastic piece 12 is self-expanding, and the barbs 123 on the side wing 122 are inserted into the gear slot 112 of the locking sleeve 11 to make the locking elastic piece 12 Fixed in the set position. In this way, the chordal control implant 10 locks the effective length of the artificial chord 200.

Pressing the pressing member 464 of the crimping button 46 drives the stop valve 45 to move toward the proximal end. The elastic member 445 drives the push rod 443 to move toward the proximal end.

Please refer to Figure 12a, Figure 12b and Figure 14. In the fourth stage, continue to rotate the control knob 421 in the reverse direction. The control knob 421 drives the push tube holder 441 and the push tube 442 to move toward the proximal end. At this time, the push rod 443 is no longer stopped. Blocked by the stop valve 45, the push rod 443 is driven by the push tube seat 441 and moves toward the proximal end, so that the push rod 443 and the push tube 442 are withdrawn from the middle of the pair of connecting elastic pieces 47, and the inner side of the pair of connecting elastic pieces 47 is lost. With the supporting force, the distal ends of the pair of connecting elastic pieces 47 shrink to the inner cavity of the connecting piece 43, thereby releasing the locking of the locking sleeve 11 and the connecting piece 43. The chordal control implant 10 is released from the distal end of the conveyor 40, and the operation is simple and convenient.

The embodiments of the present application illustrate the structure of the adjustable curved sheath 20 with reference to the accompanying drawings.

Referring to FIG. 2, the adjustable bending sheath 20 includes a sheath tube 21 and a bending control handle 22 connected to the proximal end of the sheath tube 21. The bending control handle 22 is used to control the bending of the distal end of the sheath tube 21, and the catheter 41 is movably inserted into the inner cavity of the sheath tube 21 and the inner cavity of the bending control handle 22.

Referring to Fig. 17, the distal end of the sheath tube 21 has a bending function, the bending angle range is 0-180°, and the bending area length range is 30-50mm.

The sheath tube 21 is a woven mesh structure, which is mainly formed by hot-melt composite molding of polymer materials. The distal end of the sheath tube 21 is an elastic section that can be freely bent in a certain angle range and can actively return to the initial angle direction. Between the elastic section and the proximal end of the sheath tube 21 is a long and hard tube section. The distal end of the sheath tube 21 is provided with a smooth arc-shaped end surface to reduce the damage of the distal end of the sheath tube 21 to the inner wall of the human blood vessel.

The sheath 21 is provided with at least one delivery cavity and at least one filament cavity. The delivery cavity completely penetrates from the distal end of the sheath tube 21 to the proximal end of the sheath tube 21. The filament lumen is embedded in the tube wall of the sheath tube 21. At least one anchor ring is provided at the distal end of the filament cavity. The traction wire 23 is arranged in the filament cavity.

Referring to Figure 18, the distal end of the traction wire 23 is fixed on the anchoring ring, and is drawn from the side wall near the proximal end of the sheath 21 along the filament lumen, and is connected to the bending control handle 22 On the transmission slider 221.

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

Please refer to Figure 18, the driving mode of the bending control handle 22 is threaded transmission. The outer peripheral surface of the transmission slider 221 is provided with an external thread. A rotating cylinder 222 is provided at the proximal end of the bending control handle 22. The inner side of the rotating drum 222 is provided with an internal thread that matches the external thread of the transmission slider 221.

Please refer to FIG. 18 in conjunction with FIG. 18, the mechanism of the threaded transmission of the bending control handle 22 is that the rotating drum 222 can rotate clockwise or counterclockwise, and the rotating drum 222 can be rotated to make the transmission slider 221 move in the axial direction. In this embodiment, the rotating drum 222 at the distal end of the bending control handle 22 rotates clockwise, which can drive the transmission slider 221 in the bending control handle 22 to move axially toward the proximal end, and the transmission slider 221 is pulled by the traction wire 23. The anchor ring arranged in the distal end of the sheath tube 21 is pulled to make the bending section of the distal end of the sheath tube 21 produce a bending effect.

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

The first step: push the adjustable curved sheath 20 into the aortic lumen, and continue to pass through the aortic arch, through the aortic valve and into the left ventricle.

Step 2: Fix the sheath 21, push the conveyor 40 to bring the chordal control implant 10 connected to its distal end close to the artificial chord 200, and twist the control handle 42 to make the chordal control implant 10 lock slot The opening direction of 111 points to the artificial chord 200.

Step 3: Adjust the bend of the sheath tube 21 so that the axial direction of the locking sleeve 11 is perpendicular to the artificial chord 200. Then the sheath 21 is twisted to make the locking sleeve 11 gradually stick to the artificial chord 200, so that the locking groove 111 of the locking sleeve 11 can hook the artificial chord 200.

Step 4: Turn the control knob 421 at the distal end of the control handle 42 clockwise to move the locking elastic piece 12 toward the distal end in the axial direction, and push the artificial tendon 200 into the locking sleeve 11 to contract in the shape of a "S".

Step 5: Observe the state of mitral valve regurgitation under the ultrasound state. When the regurgitation disappears, stop pushing the locking shrapnel 12. At this time, the stop valve 45 is adjusted to stick to the push rod seat 444, and the position of the push rod 443 is fixed, so that the distal end of the push rod 443 bears against the proximal end of the locking spring 12.

Step 6: Turn the control knob 421 at the distal end of the control handle 42 counterclockwise to make the push tube 442 withdraw axially until the locking spring 12 is completely released. After the locking elastic piece 12 is released, the two side wings 122 of the locking elastic piece 12 expand and open. The barbs 123 on the side wing 122 are inserted into the gear slot 112 at the corresponding position of the locking sleeve 11, so that the locking elastic piece 12 is fixed in position in the locking sleeve 11. At this time, the contraction state of the artificial tendon 200 is also fixed.

Step 7: Press the button 46 to move the stop valve 45 toward the proximal end and release it, and then continue to turn the control knob 421 on the distal end of the control handle 42 counterclockwise to make the push tube 442 and push rod 443 withdraw at the same time. The locking of the locking sleeve 11 by the connecting piece 43 at the distal end of the conveyor 40 is released. The chordal control implant 10 is detached from the distal end of the catheter 41 so as to be fixed on the artificial chord 200 and indwelled in the heart cavity.

The eighth step: sequentially withdraw the conveyor 40 and the adjustable curved sheath 20 in order to complete the adjustment of the effective length of the artificial chord 200.

The above are part of the implementation of this application. s. For those of ordinary skill in the art. Without departing from the principle of this application. Several improvements and finishings can also be made. These improvements and modifications are also regarded as the scope of protection of this application.

Claims (15)

A chord regulating implant for adjusting the effective length of an artificial chord, which is characterized in that it comprises: A wire locking sleeve, the barrel wall of the wire locking sleeve is provided with a wire locking groove communicating with the inner cavity of the wire locking sleeve, and the wire locking groove extends along the circumferential direction of the wire locking sleeve; At least two rows of a plurality of gear slots arranged in the axial direction are provided on the cylinder wall of the locking sleeve; and The locking elastic piece is arranged in the inner cavity of the locking sleeve, and the locking elastic piece includes a bearing platform and at least two side wings, and the at least two side wings respectively extend from the bearing platform to at least two rows of the gear positions. Extend on the side of the groove; When the locking groove of the locking sleeve is hooked to the artificial tendon, the at least two side wings are in a folded state; the bearing platform pushes the artificial tendon along the locking sleeve under external force The cylinder moves axially to reduce the effective length of the artificial tendon; when the effective length of the artificial tendon is reduced to the target length, the at least two side wings are expanded to engage at least two The gear slots are arranged so that part of the artificial tendon is folded and limited between the locking sleeve and the bearing platform. The chordal control implant according to claim 1, wherein the at least two side wings are provided with barbs, and the barbs are opposite to the corresponding side wings, outward and away from the carrying platform at the same time. When the at least two side wings are in an unfolded state, the barbs on the at least two side wings are respectively engaged in at least two rows of the gear slots. The chordal control implant according to claim 2, wherein the gear slot is provided between the locking groove and the proximal end of the locking sleeve; the at least two side wings are opposite to each other The supporting platforms all extend outward and obliquely toward the proximal direction of the locking sleeve, and the barbs extend outward and obliquely toward the proximal direction of the locking sleeve with respect to the corresponding side wings. The chordal control implant according to claim 3, wherein the cylinder wall of the locking sleeve is further provided with at least one guide groove extending in the axial direction, and the locking elastic piece is provided with a self At least one positioning rod extending radially outward of the bearing platform; the positioning rod is slidably inserted into the guide groove to guide the locking elastic piece to move in the axial direction in the locking sleeve. The chordal control implant according to claim 4, wherein the proximal end of the guide groove is flush with the proximal end of the locking groove, or the proximal end of the guide groove is provided on the locking groove. Between the proximal end of the wire groove and the proximal end of the locking sleeve. The chordal control implant according to claim 1, wherein a pair of oppositely arranged first connecting holes are further provided on the cylinder wall of the locking sleeve, and the first connecting holes are used to communicate with器连接。 Connectors. The chordal control implant according to any one of claims 1 to 6, wherein the circumferential extension length of the locking groove is greater than or equal to 1/2 circumference of the locking sleeve. The chordal control implant according to any one of claims 1 to 6, wherein the gear slots in the same row are uniformly distributed or non-uniformly distributed along the axial direction. A chord regulating device, characterized by comprising the chord regulating implant and a conveyor according to any one of claims 1 to 8, the conveyor comprising: A catheter and a connector connected to the distal end of the catheter, the connector being detachably connected to the locking sleeve of the chordal control implant; The control handle is connected to the proximal end of the catheter; and Pushing assembly, the pushing assembly is arranged in the containing space formed by the inner cavity of the connecting piece, the inner cavity of the catheter and the inner cavity of the control handle, the proximal end of the pushing assembly is connected with the control handle, The distal end of the pushing component makes the at least two side wings of the locking elastic piece of the chordal cord control implant in a closed state or an open state, and the pushing component is manipulated by the control handle to push the tendon Adjust the locking elastic piece of the implant to move in the axial direction, and separate the connecting piece from the wire locking sleeve. 9. The chordal control device according to claim 9, wherein the control handle comprises a control knob provided at its distal end; The push assembly includes a push tube seat and a push tube arranged coaxially with the push tube seat. The distal end of the push tube seat is screwed to the control knob, and the push tube seat is fixedly connected to the proximal end of the push tube. The push tube movably penetrates the lumen of the catheter and the lumen of the connector, and the distal end of the push tube is used to tie the proximal ends of at least two side wings of the locking elastic piece to Make the at least two side wings of the locking elastic piece in a closed state; when the push tube seat drives the push tube toward the proximal end in the axial direction under the action of the control knob, the push tube gradually contacts the At least two side wings of the locking elastic piece are separated, and at least two side wings of the locking elastic piece are expanded and engaged with at least two rows of the gear slots. The chord regulating device according to claim 10, wherein the pushing assembly further comprises a push rod and a push rod seat fixedly connected to the proximal end of the push rod, the push rod movably passes through the In the push tube, the distal end of the push rod is used to abut the proximal ends of the at least two side wings, the proximal end of the push rod extends out of the proximal end of the push tube seat, and the push rod seat is connected to the proximal end of the push tube seat. The push tube seat is connected by an elastic member. The chordal control device according to claim 11, wherein the control handle further comprises a control handle housing, the control handle housing is connected to the proximal end of the control knob, the push tube seat and the control handle The elastic member is arranged in the control handle housing; The control handle further includes a stop component provided on a side of the push rod seat away from the push rod, the stop component includes a stop valve and a pressing button connected to the stop valve, the stop The valve is arranged opposite to the push rod seat, and the crimping button is installed on the control handle housing; The crimping button is used to control the axial movement or stop of the stop valve so as to abut against the push rod seat or separate from the push rod seat. The chordal control device according to claim 12, wherein the number of the crimping buttons is two, and the two crimping buttons are symmetrically arranged on opposite sides of the stop valve, and the crimping The button includes a limiting post, a compression spring, a meshing member and a pressing member. The meshing member has a first tooth. The inner surface of the control handle housing has a second tooth that meshes with the first tooth. The limit post is connected between the engagement piece and the stop valve, and the compression spring is sleeved on the limit post and is compressed between the engagement piece and the check valve, One end of the pressing member is arranged 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. The chordal control device according to claim 11, wherein a pair of second connecting holes communicating with the inner cavity of the connecting member are provided on the outer peripheral surface of the distal end of the connecting member; The conveyor further includes a pair of oppositely arranged connecting elastic pieces, and the proximal end of the connecting elastic pieces is engaged with the wall surface of the connecting piece; When the outer peripheral surface of the push tube pushes against the connecting elastic piece, the distal end of the connecting elastic piece is engaged with the second connecting hole and the first connecting hole on the locking sleeve, so that the connecting Piece connected to the locking sleeve; When the push tube and the push rod move toward the proximal end in the axial direction to separate from the connecting elastic piece, the distal end of the connecting elastic piece moves closer to the center and moves out of the first connecting hole and the second connecting hole. The connecting hole is used to separate the connecting piece from the locking sleeve. A chordal control system, characterized in that it comprises an adjustable curved sheath and the chordal control device according to any one of claims 9 to 14, wherein the adjustable curved sheath comprises a sheath and a sheath connected to the sheath. A proximal bending control handle, the bending control handle is used to control the distal end of the sheath to bend, the catheter movably penetrates the inner cavity of the sheath and the inner cavity of the bending control handle in.

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