CN114681137A

CN114681137A - Chordae tendineae regulating and controlling device

Info

Publication number: CN114681137A
Application number: CN202011614641.8A
Authority: CN
Inventors: 张庭超; 郭荣辉
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2020-12-30
Filing date: 2020-12-30
Publication date: 2022-07-01

Abstract

The invention discloses a tendon rope regulating and controlling device, which comprises: the automatic control device comprises a guide assembly, a self-rebounding piece and at least one control line. After the tendon rope regulating device is conveyed to the position near the tendon rope, the guiding assembly is retracted towards the near end, at the moment, the self-rebounding piece extends out of the inner cavity of the far end of the guiding assembly, the far end of the self-rebounding piece is inserted into the limiting through hole under the action of self-rebounding force to form a closed ring, and the closed ring folds the tendon rope, so that the effective length of the tendon rope is shortened; then, if the mitral valve is not restored to a completely closed state under the action of ultrasonic equipment, the control line is pulled back and forth to the proximal end to further adjust the diameter of the closed ring, so that the effective length of the chordae tendineae can be adjusted in real time; and if the mitral valve is observed to return to the completely closed state, stopping pulling to perform locking and fixing. Adopt the chordae tendineae regulation and control device of this application can realize adjusting chordae tendineae effective length in real time according to the mitral valve state to guarantee the operation effect.

Description

Tendon rope regulating and controlling device

Technical Field

The application belongs to the technical field of medical instrument, particularly, relates to a chordae tendinae regulation and control device.

Background

The heart is composed of four cavities, namely a left atrium, a left ventricle, a right atrium and a right ventricle, the left atrium and the right atrium and the left ventricle are separated by intervals and are not communicated with each other, and valves (atrioventricular valves) are arranged between the atria and the ventricles, so that blood can only flow into the ventricles from the atria and can not flow backwards.

The mitral valve is a one-way "valve" between the Left Atrium (LA) and the Left Ventricle (LV), which ensures blood flow from the left atrium to the left ventricle. A normal, healthy mitral valve has a plurality of Chordae Tendineae (CT). 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 are not flushed to the atrium side by blood flow, and the anterior and posterior leaflets are closed well, thereby ensuring that blood flows from the left ventricle to the aorta through the aortic valve (AV for short). If the chordae tendineae are diseased, such as long chordae tendineae, when the left ventricle is in a contracted state, the mitral valve cannot return to a closed state as in a normal state, and the momentum of blood flow further causes the leaflets to fall into the left atrium, causing prolapse of the leaflets and blood backflow.

Among the prior art, a series of chordae tendinae regulation and control devices have been designed in order to realize the technological effect who shortens the chordae tendinae, when adopting this type of chordae tendinae regulation and control device to shorten the effective length of chordae tendineae, owing to can only carry out the effective length of fixed parameter and shorten, consequently, the operator realizes that the effective length after shortening is improper, when leading to the mitral valve closure incomplete, then can't further carry out real-time regulation to the effective length of chordae tendineae to influence operation effect, lead to the failure even.

Disclosure of Invention

An object of the application is to provide a chordae tendineae regulation and control device to solve the chordae tendineae regulation and control device among the prior art and implanted the human body after, can't carry out the technical problem who adjusts in real time to the effective length of chordae tendineae according to the mitral valve state.

To achieve the above object, the present invention provides a chordae tendineae regulating device comprising:

a guide assembly having an inner cavity;

the self-rebounding piece is made of a shape memory material, movably penetrates through the inner cavity of the guide assembly, and two communicated limiting through holes are formed in the outer wall, close to the near end, of the self-rebounding piece; and

the adjusting and controlling wire penetrates through the inner cavity of the self-rebounding piece and is movably connected with the far end of the self-rebounding piece;

when the self-rebounding piece extends out of the inner cavity of the far end of the guide assembly, the far end of the self-rebounding piece is inserted into the limiting through hole under the action of self rebounding force to form a closed ring used for gathering the chordae tendineae, and the regulating and controlling line is used for regulating the diameter of the closed ring.

Compared with the prior art, the invention has the following beneficial effects:

the invention discloses a tendon rope regulating and controlling device, which comprises: the device comprises a guide assembly, a self-rebounding piece and at least one regulating and controlling wire. After the tendon rope regulating device is conveyed to the position near the tendon rope, the guiding assembly is retracted towards the near end, at the moment, the self-rebounding piece extends out of the inner cavity of the far end of the guiding assembly, the far end of the self-rebounding piece is inserted into the limiting through hole under the action of self-rebounding force to form a closed ring, and the closed ring folds the tendon rope, so that the effective length of the tendon rope is shortened; then, if the mitral valve is not restored to a completely closed state under the action of ultrasonic equipment, the control line is pulled back and forth to the proximal end to further adjust the diameter of the closed ring, so that the effective length of the chordae tendineae can be adjusted in real time; and if the mitral valve is observed to return to the completely closed state, stopping pulling to perform locking and fixing. In conclusion, the tendon regulation and control device can realize real-time regulation of the effective length of the tendon according to the state of the mitral valve, so that the operation effect is ensured.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and together with the description, serve to explain the principles of the invention.

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious for those skilled in the art that other drawings can be obtained according to the drawings without inventive exercise.

Fig. 1 is a schematic structural view illustrating a chordae regulating device according to an exemplary embodiment.

Fig. 2 is a schematic structural view of a guide assembly according to an exemplary embodiment.

FIG. 3 is a schematic diagram illustrating the construction of a self-rebounding element in a flat condition according to an exemplary embodiment.

Fig. 4 is a schematic structural view illustrating a self-elastic member after forming a closed loop under self-elastic force according to an exemplary embodiment.

Fig. 5 is a partially enlarged view of a position a in fig. 4.

Fig. 6 is a partially enlarged view of a portion B in fig. 4.

FIG. 7 is a cross-sectional view of a self-rebounding element shown in accordance with an exemplary embodiment.

Fig. 8 is a cross-sectional view of a self-rebounding element shown in accordance with yet another exemplary embodiment.

Fig. 9 is a partial enlarged view of the position C in fig. 8.

FIG. 10 is a schematic diagram illustrating the mating of the locking structure, the adjustment wire, and the locking control wire, according to an exemplary embodiment.

FIG. 11 is a schematic diagram illustrating a latch plate according to one exemplary embodiment.

Figure 12 is a schematic diagram illustrating mating of a locking structure with a wire guide according to an exemplary embodiment.

Fig. 13 is a schematic diagram of a wire guide configuration according to an exemplary embodiment.

Figure 14 is a schematic view of the delivery of the chordae modulating device to the vicinity of the chordae.

Figure 15 is a schematic view of a length of delivery catheter extending from a resilient member.

Fig. 16 is a schematic view of the self-resilient member under its own resilient force to form a closed loop.

Figure 17 is a schematic view of the self-rebounding element separated from the push tube.

FIG. 18 is a schematic view of the guide assembly and the pusher tube after being withdrawn from the body.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are some embodiments of the present application, but not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

It should be understood that the directions or positional relationships indicated by "front", "back", "upper", "lower", "left", "right", "longitudinal", "lateral", "vertical", "horizontal", "top", "bottom", "inner", "outer", "head", "tail", etc. are configured and operated in specific directions based on the directions or positional relationships shown in the drawings, and are only for convenience of describing the present technical solution, but not for indicating that the device or element referred to must have a specific direction, and thus, cannot be construed as limiting the present invention.

It is also noted that, unless expressly stated or limited otherwise, the terms "mounted," "connected," "secured," "disposed," and the like are intended to be inclusive and mean, for example, that they may be fixedly connected, detachably connected, or integrally formed. Either directly or indirectly through intervening media, either internally or in any other relationship. When an element is referred to as being "on" or "under" another element, it can be "directly" or "indirectly" on the other element or intervening elements may also be present. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In the description of the present invention, it is still to be noted that the proximal end refers to the end of the instrument or component near the operator, and the distal end refers to the end of the instrument or component away from the operator. Axial refers to a direction parallel to the line joining the distal and proximal centers of the instrument or component, radial refers to a direction perpendicular to the axial direction, and circumferential refers to a direction around the axial direction.

In order to solve the technical problem that the effective length of the chordae tendineae cannot be adjusted in real time according to the mitral valve state after the chordae tendineae adjusting and controlling device in the prior art is implanted into a human body, as shown in fig. 1 to 18, the invention discloses a chordae tendineae adjusting and controlling device, comprising:

a guide assembly 100, the guide assembly 100 having an interior cavity.

In one embodiment, as shown in fig. 1 and 2, the guide assembly 100 includes: the self-resilient member 200 is movably disposed through the inner cavity of the delivery catheter 110 by the delivery handle 120, wherein the delivery catheter 110 may be a flexible tube made of a single-layer material, such as a nylon tube, a polyetheretherketone tube, or the like, or a multi-layer composite tube, preferably, the inner membrane is made of polytetrafluoroethylene, the middle layer is made of a metal woven mesh, and the outer layer is made of a block-type polyetheramide elastomer. Of course, it should be understood that the materials herein are for example only and not limiting, and that other materials may be used by one of ordinary skill in the art based on the teachings herein without departing from the scope of the present application.

The self-rebounding piece 200 is made of a shape memory material, the self-rebounding piece 200 is movably arranged in the inner cavity of the guide assembly 100 in a penetrating mode, and two communicated limiting through holes 210 are formed in the outer wall, close to the near end, of the self-rebounding piece 200.

As shown in fig. 4, 5 and 7, the outer diameter of the self-resilient member 200 at the proximal end is larger than the outer diameter at the distal end, and the self-resilient member 200 is smoothly transitioned from the proximal end to the distal end. Illustratively, the inner diameter of the proximal end of the self-resilient member 200 is preferably 5mm to 7mm, the wall thickness is preferably 0.1mm to 0.5mm, the outer diameter of the distal end of the self-resilient member 200 is preferably 2mm to 3mm, and the wall thickness is preferably 0.1mm to 0.5 mm. Specifically, be closed cyclic annular from resilience piece 200 under natural state, that is to say, insert spacing through-hole 210 and form the closed ring from the distal end of resilience piece 200 under the effect of self resilience power, through the effective length of the diameter of real-time regulation closed ring in order to shorten the chordae tendinae. When the self-resilient member 200 is inserted into the lumen of the delivery catheter 110, the self-resilient member 200 is forced to change from a closed loop to a flat state under the restriction of the wall of the delivery catheter 110.

In addition, in order to ensure that the distal end of the self-resilient member 200 can be smoothly inserted into the limiting through hole 210 disposed at the proximal end under the action of the self-resilient force, the aperture of the limiting through hole 210 is preferably larger than the outer diameter of the distal end of the self-resilient member 200, and the aperture of the limiting through hole 210 is exemplarily greater than or equal to 4 mm.

In a preferred embodiment, self-resilient member 200 has an inner lumen and is made of a material that is well biocompatible and has a shape memory function, illustratively, a nickel-titanium alloy. The self-rebounding element 200 may be made of a single piece of nitinol, or may be formed by splicing nitinol of different diameters. When in manufacturing. Heat treated and preformed into a closed ring. The closed rings respectively have a preset minimum diameter L1 and a maximum diameter L2 after being adjusted to be folded and locked. As shown in fig. 4, the minimum diameter L1 of the closed loop refers to the diameter at the initial state when the self-resilient member 200 springs back into the closed loop, when the diameter of the closed loop is the smallest, which is 8 mm. The maximum diameter L2 of the closed loop is the maximum diameter of the closed loop after being adjusted and locked when the resilient member 200 is rebounded to the closed loop, and the maximum diameter is 15mm, so as to ensure the effective adjustment range of the chordae tendineae.

It should be noted that the above value ranges are provided because the mitral annulus is typically about 30mm in diameter and the chordae regulating position is substantially between the annulus and apex 1/2. When the diameter of the closed ring is larger than 15mm, no contraction effect is produced; when the diameter of the closed ring is less than 8mm, the valve orifice may be narrowed, thereby affecting the operation effect.

It will be appreciated that, alternatively, the self-rebounding element 200 includes a body, which may be selected from one of a tubular structure and a rod-like structure, and may also be a solid structure, but requires a channel and at least one control wire 300, and is inserted into the inner cavity of the self-rebounding element 200, and the control wire 300 is movably connected to the distal end of the self-rebounding element 200.

It is understood that, alternatively, the self-resilient member 200 may also be made by combining a body with a dense structure or a mesh structure and a polymer coating or coating, wherein the body is made of shape memory material such as nitinol through laser cutting or weaving, and after heat setting, a biocompatible polymer coating or coating such as PET or PTFE is applied to at least a portion of the outer surface of the body.

After the self-rebounding element 200 extends out of the distal lumen of the guiding assembly 100, the distal end of the self-rebounding element 200 is inserted into the limiting through hole 210 under the action of self-rebounding force to form a closed loop for closing the chordae tendineae, and the adjusting line 300 is used for adjusting the diameter of the closed loop.

In one embodiment, as shown in fig. 4, 8 and 10, the control wire 300 is used to pull the distal end of the resilient member 200 back and forth toward or away from the insertion limiting through hole 210 to adjust the diameter of the closed loop to further adjust the effective length of the closed chordae tendineae. In this embodiment, in order to save cost, it is preferable to set the number of the control lines 300 to one. To facilitate the adjustment of the diameter of the self-resilient member 200, as shown in fig. 6, it is preferable that at least one pair of adjustment through holes 220 is provided at the distal end of the self-resilient member 200, the adjustment wire 300 is passed through the adjustment through holes 220 along either free end, and each free end of the adjustment wire 300 extends proximally in the axial direction of the self-resilient member 200. In this embodiment, the number of the regulating through holes 220 is set as a pair, two regulating through holes 220 are adjacently disposed along the radial direction of the distal end of the self-resilient member 200, after one regulating wire 300 is bent into a "U" shape, two free ends correspondingly pass through the two regulating through holes 220, and then both free ends extend along the axial direction of the self-resilient member 200 to the proximal end until extending out of the delivery catheter 110, so as to be convenient for the operator to use. Specifically, when further adjustment of the diameter of the closed loop is required, the operator simply holds both free ends at the same time and pulls the control wire 300 back and forth to adjust the diameter of the closed loop to the proper position. When the adjusting and controlling wire 300 needs to be withdrawn, the operator only needs to hold any one of the free ends and pull the free end to the proximal end until the adjusting and controlling wire 300 is completely withdrawn from the human body. The adjusting and controlling line 300 can be selected from medical grade PET lines, multi-strand stainless steel lines and other medical grade lines which do not cause damage to human bodies, and 2-0PET suture lines are preferred.

The specific operation process of real-time regulation and control is as follows: after carrying near the chordae tendineae with chordae tendineae regulation and control device, withdrawing guide assembly 100 to the near-end, this moment, will stretch out from the distal end inner chamber of guide assembly 100 from resilient member 200, insert spacing through-hole 210 under the effect of self resilience from the distal end of resilient member 200 and form the closed ring, this closed ring is drawn in the chordae tendineae to shorten the effective length of chordae tendineae. Then, if the mitral valve is not restored to a completely closed state under the action of the ultrasonic equipment, the control line 300 is only required to be pulled back and forth towards the near end to adjust the diameter of the closed ring, so that the effective length of the chordae tendineae can be adjusted in real time; and if the mitral valve is observed to return to the completely closed state, stopping pulling to perform locking and fixing. To sum up, adopt the chordae tendineae regulation and control device of this application can realize according to the mitral valve state, adjusting chordae tendineae effective length in real time to guarantee the operation effect.

According to a preferred embodiment of the present invention, in order to further ensure that the distal end of the self-rebounding element 200 can be smoothly inserted into the limiting through hole 210 disposed at the proximal end under the action of the self-rebounding force, as shown in fig. 9, the centers of the two limiting through holes 210 are staggered, that is, the centers of the two limiting through holes 210 are not on a straight line, and the line connecting the two centers of the two limiting through holes forms an acute angle with the tube wall of the self-rebounding element 200.

In order to lock the adjusted effective length, as shown in fig. 8-13, the inner cavity of the self-resilient member 200 is further provided with a locking structure 400, and the locking structure 400 is used for locking the distal end of the self-resilient member 200 inserted into the limiting through-hole 210.

Specifically, the locking structure 400 includes: one end of the locking sheet 410 is connected to the inner wall surface of the self-rebounding piece 200 and is close to the position of the near end of the limiting through hole 210, the other end of the locking sheet is a free end and at least one locking control line 420, the locking control line 420 penetrates through the inner cavity of the self-rebounding piece 200, and the locking control line 420 is movably connected with the locking sheet 410.

In one specific embodiment, as shown in fig. 11, the locking plate 410 is made of a material that has good biocompatibility and a shape memory function. Exemplary are nitinol, and the like. The width of the locking sheet 410 is not suitable to be too narrow or too short, otherwise, the phenomenon that the locking force on the effective length of the chordae tendineae is insufficient due to insufficient tension of the locking sheet occurs; while being too wide or too long tends to interfere with the control line 300 and the lock control line 420. Thus, the ratio of the width of the locking tab 410 to the inner diameter of the proximal end of the self-rebounding element 200 is 1/3-2/3, preferably 1/2. The ratio of the length of the locking tab 410 to the inner diameter of the proximal end of the self-rebounding element 200 is 1/3-3/4, preferably 2/3, to ensure that the locking effect on the effective length of the tendon is ensured while not interfering with the control wire 300 and the locking control wire 420.

As shown in fig. 5, 9, 10, 11 and 12, the locking control line 420 is configured to drive the free end of the locking plate 410 to move towards the distal direction of abutting against the self-rebounding member 200 to lock the self-rebounding member 200, and the locking control line 420 is configured to drive the free end of the locking plate 410 to move towards the distal direction away from the self-rebounding member 200 to release the self-rebounding member 200. In this embodiment, it is preferable to set the number of the locking control lines 420 to one for cost saving. To facilitate adjustment of the distal end of the self-locking tab 410, as shown in fig. 11, it is preferable that at least one pair of locking through holes 411 is formed at the free end of the self-locking tab 410, the locking control wire 420 correspondingly passes through the locking through holes 411 along either free end, and each free end of the locking control wire 420 extends proximally along the axial direction of the self-locking tab 410. In this embodiment, the number of the locking through holes 411 is set as a pair, two locking through holes 411 are adjacently disposed along the radial direction of the distal end of the self-resilient member 200, after one locking control line 420 is bent into a "U" shape, two free ends correspondingly pass through the two locking through holes 411, and then both free ends extend proximally along the axial direction of the self-locking piece 410 until extending out of the delivery catheter 110, so as to be convenient for the operator to use. Specifically, when self-rebounding element 200 extends from the distal lumen of guide assembly 100, the operator, on the one hand, holds both free ends simultaneously, pulling proximally on locking control wire 420, thereby causing simultaneous proximal movement of locking tabs 410 to release self-rebounding element 200. Meanwhile, on the other hand, because the locking control line 420 and the mutual action between the tractive end of the locking piece 410, the locking control line 420 can generate an acting force opposite to the direction of the regulating and controlling line 300, and the acting force can lead the near end of the self-rebounding piece 200 to play a role in fixing when the regulating and controlling line 300 is tractive, thereby further realizing the free penetration of the far end of the self-rebounding piece 200 in the limiting through hole 210 through the tractive regulating and controlling line 300, realizing the real-time regulation of the diameter of the closed ring, and further realizing the real-time regulation of the effective length of the tendon. Finally, if the current effective length of the chordae tendineae is observed to be the required effective length, the operator only needs to hold any one of the free ends of the locking control wire 420 and pull the wire towards the proximal end until the locking control wire 420 is completely withdrawn from the body. At this time, as shown in fig. 5, under the effect of the self-rebounding force, the free end of the locking piece 410 will move toward the direction close to the distal end of the self-rebounding piece 200 until colliding against the distal end of the self-rebounding piece 200 to lock the self-rebounding piece 200, so as to lock the effective length of the current tendon. The locking control line 420 can be selected from medical grade PET thread, multi-strand stainless steel wire and other medical grade thread which does not cause damage to human body, and 2-0PET suture is preferred.

According to an embodiment of the present invention, the free end of the locking piece 410 is bent in a direction approaching the limiting through-hole 210 by a predetermined angle. Specifically, during machining, the locking piece 410 is in a flat sheet shape in a natural state, and is preformed into a sheet shape bent towards the direction close to the limiting through hole 210 shown in fig. 11 after heat treatment, and the bent angle is an acute angle, so that the elastic force of the locking piece 410 is further improved, and the locking capacity of the locking piece 410 on the far end of the self-resilience member 200 is further improved.

According to an embodiment of the present invention, in order to further ensure that the distal end of the self-rebounding element 200 can be smoothly inserted into the limiting through hole 210 disposed at the proximal end under the action of the self-rebounding force, as shown in fig. 5, 9, 10, 12, and 13, a wire guide 500 is further disposed in the inner cavity of the self-rebounding element 200, the wire guide 500 is fixedly connected to the inner side wall of the self-rebounding element 200 and is staggered from the limiting through hole 210, and the control wire 300 passes through the inner cavity of the wire guide 500, as shown in fig. 10 and 12, the wire guide 500 designed according to this embodiment may be configured to accommodate the control wire 300 corresponding to the limiting through hole 210 in the wire guide 500, so as to ensure that the distal end of the self-rebounding element 200 can be more smoothly inserted into the limiting through hole 210 disposed at the proximal end under the action of the self-rebounding force.

Specifically, as shown in fig. 12 and 13, the wire guide 500 has a hollow flat tubular shape as a whole, and preferably, the length of the wire guide 500 is equal to or greater than the axial length of the limiting through hole 210. Illustratively, the range of lengths of the wire guide 500 is: 10mm-20mm, the wall thickness of the wire guide 500 ranges from 0.2 to 0.4mm, and the lumen width of the wire guide 500 ranges from 0.5mm to 1 mm. The wire guide 500 is made of a rigid or semi-rigid material having good biocompatibility, and PEEK, SUS316L, NiTi, etc. are used as an example.

According to an embodiment of the present invention, as shown in fig. 1, the tendon control device further comprises a push tube 600, and the push tube 600 is detachably connected to the proximal end of the self-resilient member 200. Specifically, the pushing tube 600 is movably inserted into the inner cavity of the delivery catheter 110 through the delivery handle 120, and can be detachably connected to the proximal end of the self-resilient member 200 through a sleeve connection, a snap connection, a threaded connection, or the like. When an abnormal situation occurs or the release position of the self-rebounding element 200 is not ideal, it is allowed to withdraw the self-rebounding element 200 through the push tube 600 inside the delivery catheter 110, thus achieving repentance. The push tube 600 is made of a rigid material with certain flexibility, for example, nickel-titanium alloy or the like, and the inner diameter and the outer diameter of the push tube 600 are consistent with the proximal end of the self-resilient member 200, so that the delivery operation is facilitated.

The operation steps of this embodiment are described below with reference to the accompanying drawings:

the method comprises the following steps: as shown in fig. 14, the chordae modulating device of the present application is delivered to the vicinity of the mitral valve chordae via the femoral-abdominal aorta-thoracic aorta-aortic valve orifice in sequence.

Step two: as shown in fig. 15, the self-resilient member 200 is pushed out of the distal lumen of the guide assembly 100 by the push tube 600 to a certain length, at which time the distal end of the self-resilient member 200 begins to collapse around the chordae tendineae under its own resilient force.

Step three: as shown in fig. 16, the pushing tube 600 is driven continuously until the self-resilient member 200 is completely pushed out from the distal lumen of the guide assembly 100, at which time the distal end of the self-resilient member 200 is inserted into the limiting through-hole 210 under its own resilient force to form a closed loop for closing the chordae tendineae, and the diameter of the closed loop is adjusted by pulling the adjusting wire 300 back and forth under the action of the ultrasonic device. Until the current mitral valve closing state is observed to be an expected state through the ultrasound device, the locking control line 420 drives the free end of the locking plate 410 to move towards the distal direction against the self-rebounding member 200 to lock the self-rebounding member 200, so as to lock the adjusted diameter of the closing ring, and further lock the effective length of the current chordae tendineae.

Step four: as shown in fig. 17, the release operation of the self-resilient member 200 is completed by withdrawing the locking control wire 420 and the control wire 300 by pulling one free end of the proximal end thereof and one free end of the proximal end thereof, respectively, to disengage the self-resilient member 200.

Step five: as shown in FIG. 18, the delivery tube is finally withdrawn from the body, thereby completing the surgical procedure.

The foregoing are merely exemplary embodiments of the present invention, which enable those skilled in the art to understand or practice the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A chordae modulating device comprising:

a guide assembly having an inner cavity;

the self-rebounding piece is made of a shape memory material, the self-rebounding piece is movably arranged in the inner cavity of the guide assembly in a penetrating mode, and two communicated limiting through holes are formed in the outer wall, close to the near end, of the self-rebounding piece; and

2. The tendon management device of claim 1 wherein the limiting through-hole has a bore diameter greater than the outer diameter of the distal end of the self-resilient member, and the self-resilient member is rounded in a proximal to distal direction.

3. The chordae modulating device of claim 1, wherein the centers of the two limiting through holes are staggered.

4. The tendon management device of claim 1, wherein the distal end of the self-resilient member is provided with at least one pair of management through-holes through which the management wire passes along either free end, each free end of the management wire extending proximally along the axial direction of the self-resilient member.

5. The tendon management device of claim 1 wherein the inner cavity of the self-rebounding element further comprises a locking structure for locking a distal end of the self-rebounding element inserted into the limiting through-hole.

6. The chordae modulating device of claim 5, wherein the locking structure comprises:

one end of the locking sheet is connected to the inner wall surface of the self-rebounding piece and is close to the position of the near end of the limiting through hole, and the other end of the locking sheet is a free end; and

at least one locking control line is arranged in the inner cavity of the self-rebounding piece in a penetrating mode, and the locking control line is movably connected with the locking piece;

the locking control line is used for driving the free end of locking piece to contradicting the distal end direction motion of kick-back piece is in order to lock the kick-back piece, the locking control line is used for driving the free end of locking piece is to keeping away from the distal end direction motion of kick-back piece is in order to release the kick-back piece.

7. The tendon management device of claim 6 wherein the locking tab has at least one pair of locking through holes formed in a free end thereof, the locking control wire passing through the locking through holes along either free end, each free end of the locking control wire extending proximally along the axial direction of the self-rebounding element.

8. The tendon control apparatus of claim 6 wherein the ratio of the width of the locking plate to the proximal inner diameter of the self-rebounding element is 1/3-2/3 and the ratio of the length of the locking plate to the proximal inner diameter of the self-rebounding element is 1/3-3/4.

9. The tendon regulating device of claim 6, wherein the free end of the locking tab is bent in a direction approaching the limiting through hole, and the bent angle is an acute angle.

10. The tendon rope regulating and controlling device according to claim 1, wherein the inner cavity of the self-rebounding element is further provided with a wire guide, the wire guide is arranged in the inner cavity of the self-rebounding element, the wire guide is fixedly connected with the inner side wall of the self-rebounding element and staggered with the limiting through hole, and the regulating and controlling wire passes through the inner cavity of the wire guide.

11. The chordae modulating device of claim 10, wherein the length of the wire guide is greater than or equal to the axial length of the stop through hole.

12. The tendon control of claim 1 further comprising a push tube removably connected to the proximal end of the self-resilient member.

13. The chordae regulating device of claim 12, wherein the guide assembly comprises: the conveying device comprises a conveying catheter and a conveying handle sleeved on the outer side of the conveying catheter, wherein the self-rebounding piece and the pushing pipe are movably arranged in an inner cavity of the conveying catheter in a penetrating mode through the conveying handle.

14. The chordae modulating device of claim 1, wherein the closed loop has a diameter in the range 8-15 mm.

15. The chordae modulating device of claim 1, wherein the self-resilient element comprises a body selected from one of a tubular structure or a rod-like structure, the tubular or rod-like structure being a dense or reticulated structure.

16. The chordae modulating device of claim 15, wherein a biocompatible polymer coating or biocompatible coating is applied to at least part of the outer surface of the body.