A tendon control device

Abstract

The present invention discloses a tendon chord regulating device, comprising: a guide assembly, a self-resilient member and at least one regulating wire. After the tendon chord regulating device is delivered to the vicinity of the tendon chord, the guide assembly is withdrawn toward the proximal end, at which time the self-resilient member will extend from the distal inner cavity of the guide assembly, and the distal end of the self-resilient member will be inserted into the limiting through hole under the action of its own resilience to form a closed loop, which will gather the tendons, thereby shortening the effective length of the tendons; if it is then observed under the action of an ultrasonic device that the mitral valve has not recovered to a fully closed state, at this time, it is only necessary to pull the regulating wire back and forth toward the proximal end to further adjust the diameter of the closed loop, thereby achieving real-time adjustment of the effective length of the tendons; if it is observed that the mitral valve has recovered to a fully closed state, stop pulling and lock and fix it. The tendon chord regulating device of the present application can achieve real-time adjustment of the effective length of the tendons according to the state of the mitral valve, thereby ensuring the surgical effect.

Description

Technical Field

[0001] The present application belongs to the field of medical device technology, and specifically, relates to a tendon chord regulation device. Background Art

[0002] The heart is composed of four chambers: the left atrium, left ventricle, right atrium, and right ventricle. The left and right atria and the left and right ventricles are separated by partitions, so they are not connected to each other. There are valves (atrioventricular valves) between the atria and ventricles. These valves prevent blood from flowing from the atria to the ventricles and not flowing back.

[0003] The mitral valve is a one-way "valve" between the left atrium (abbreviated as: LA) and the left ventricle (abbreviated as: LV), which can ensure that blood flows from the left atrium to the left ventricle. A normal and healthy mitral valve has multiple chordae tendineae (abbreviated as: CT). The leaflets of the mitral valve are divided into anterior leaflets and posterior leaflets. When the left ventricle is in diastole, both are in an open state, and blood flows from the left atrium to the left ventricle; when the left ventricle is in contraction, the chordae tendineae are stretched to ensure that the leaflets are not washed to the atrial side by the blood flow, and the anterior and posterior leaflets are well closed, thereby ensuring that blood flows from the left ventricle through the aortic valve (abbreviated as: AV) to the aorta. If the chordae tendineae are diseased, such as the chordae tendineae are too long, when the left ventricle is in contraction, the mitral valve cannot return to the closed state as in the normal state, and the impact of the blood flow will further cause the leaflets to dislodge into the left atrium, causing leaflet prolapse and blood reflux.

[0004] In the prior art, a series of chord regulating devices have been designed to achieve the technical effect of shortening the chordae tendineae. When such chord regulating devices are used to shorten the effective length of the chordae tendineae, only the effective length shortening with fixed parameters can be performed. Therefore, when the operator realizes that the effective length after shortening is not appropriate, resulting in incomplete closure of the mitral valve, the effective length of the chordae tendineae cannot be further adjusted in real time, thereby affecting the surgical effect and even causing failure. Summary of the invention

[0005] The purpose of the present application is to provide a tendon chord regulating device to solve the technical problem in the prior art that after the tendon chord regulating device is implanted in the human body, the effective length of the tendons cannot be adjusted in real time according to the state of the mitral valve.

[0006] To achieve the above object, the present invention provides a tendon chord regulating device, comprising:

[0007] a guide assembly having an inner cavity;

[0008] A self-resilient member, made of a shape memory material, movably disposed in the inner cavity of the guide assembly, and having two communicating limiting through holes disposed on the outer wall of the self-resilient member near the proximal end; and

[0009] At least one regulating wire is passed through the inner cavity of the self-resilient member, and the regulating wire is movably connected to the distal end of the self-resilient member;

[0010] When the self-resilient member extends out from the distal inner cavity of the guide assembly, the distal end of the self-resilient member is inserted into the limiting through hole under the action of its own rebound force to form a closed loop for gathering the tendon cords, and the regulating line is used to adjust the diameter of the closed loop.

[0011] Compared with the prior art, the present invention has the following beneficial effects:

[0012] The present invention discloses a tendon chord regulating device, comprising: a guide assembly, a self-resilient member and at least one regulating wire. After the tendon chord regulating device is delivered to the vicinity of the tendon chord, the guide assembly is withdrawn toward the proximal end, at which time the self-resilient member will extend from the distal inner cavity of the guide assembly, and the distal end of the self-resilient member will be inserted into the limiting through hole under the action of its own resilience to form a closed loop, which will gather the tendons, thereby shortening the effective length of the tendons; if it is then observed under the action of an ultrasonic device that the mitral valve has not returned to a fully closed state, at this time, it is only necessary to pull the regulating wire back and forth toward the proximal end to further adjust the diameter of the closed loop, thereby achieving real-time adjustment of the effective length of the tendons; if it is observed that the mitral valve has returned to a fully closed state, stop pulling and lock and fix it. In summary, the tendon chord regulating device of the present application can achieve real-time adjustment of the effective length of the tendons according to the state of the mitral valve, thereby ensuring the surgical effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] 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.

[0014] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, for ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0015] Figure 1 It is a schematic structural diagram of a tendon chord regulating device according to an exemplary embodiment.

[0016] Figure 2 It is a schematic structural diagram of a guide assembly according to an exemplary embodiment.

[0017] Figure 3 FIG. 4 is a schematic structural diagram of a self-resilient member in a straight state according to an exemplary embodiment.

[0018] Figure 4It is a schematic diagram of the structure of a self-resilient member after forming a closed loop under the action of its own resilience force according to an exemplary embodiment.

[0019] Figure 5 for Figure 4 A partial enlarged view of position A in the middle.

[0020] Figure 6 for Figure 4 A partial enlarged view of position B in the middle.

[0021] Figure 7 is a cross-sectional view of a self-resilient member according to an exemplary embodiment.

[0022] Figure 8 is a cross-sectional view of a self-resilient member according to yet another exemplary embodiment.

[0023] Fig. 9 for Figure 8 A partial enlarged view of the C position in the middle.

[0024] Fig.10 It is a schematic diagram of the structure of the locking structure, the regulating wire and the locking control wire according to an exemplary embodiment.

[0025] Fig.11 FIG. 4 is a schematic structural diagram of a locking plate according to an exemplary embodiment.

[0026] Fig.12 It is a schematic structural diagram showing the cooperation between a locking structure and a wire guide according to an exemplary embodiment.

[0027] Fig.13 FIG. 4 is a schematic structural diagram of a wire guide according to an exemplary embodiment.

[0028] Fig.14 Schematic diagram of delivering the chord regulation device to the vicinity of the chords.

[0029] Fig.15 It is a schematic diagram showing that a certain length of the delivery conduit is extended from the resilient member.

[0030] Fig.16 It is a schematic diagram of a self-resilient member forming a closed loop under the action of its own elastic force.

[0031] Fig.17 Schematic diagram of the separation of the self-rebounding part and the push tube.

[0032] Fig.18 This is a schematic diagram of the guide assembly and the push tube after being withdrawn from the human body. DETAILED DESCRIPTION

[0033] In order to make the purpose, technical solution and advantages of the embodiments of the present application clearer, the technical solution in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0034] It should be understood that the directions or positional relationships indicated by “front”, “back”, “up”, “down”, “left”, “right”, “longitudinal”, “horizontal”, “vertical”, “horizontal”, “top”, “bottom”, “inside”, “outside”, “head”, and “tail”, etc., are based on the directions or positional relationships shown in the drawings, and are constructed and operated in specific directions. They are only for the convenience of describing the technical solution, and do not indicate that the device or element referred to must have a specific direction. Therefore, it should not be understood as a limitation on the present invention.

[0035] It should also be noted that, unless otherwise clearly specified and limited, the terms such as "installed", "connected", "connected", "fixed", "set" and the like should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral one. It can be directly connected or indirectly connected through an intermediate medium. It can be the internal connection of two elements or the interaction relationship between two elements. When an element is referred to as being "on" or "under" another element, the element can be "directly" or "indirectly" located on the other element, or there may be one or more intervening elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances.

[0036] In the description of the present invention, it is still necessary to explain that the proximal end refers to the end of the instrument or component close to the operator, and the distal end refers to the end of the instrument or component away from the operator. The axial direction refers to the direction parallel to the center line of the distal end and the proximal end of the instrument or component, the radial direction refers to the direction perpendicular to the axial direction, and the circumferential direction refers to the direction around the axial direction.

[0037] In order to solve the technical problem that the chordae tendineae regulating device in the prior art cannot adjust the effective length of the chordae tendineae in real time according to the state of the mitral valve after being implanted in the human body, Figure 1-Figure 18 As shown, the present invention discloses a tendon chord regulating device, comprising:

[0038] The guide assembly 100 has an inner cavity.

[0039] In a specific embodiment, Figure 1 and Figure 2As shown, the guide assembly 100 includes: a delivery catheter 110 and a delivery handle 120 sleeved on the outside of the delivery catheter 110, and the self-resilient member 200 is movably arranged in the inner cavity of the delivery catheter 110 via the delivery handle 120, wherein the delivery catheter 110 can be a flexible tube made of a single-layer material, exemplarily, a nylon tube, a polyetheretherketone tube, etc., and of course it can also be a multi-layer composite tube, preferably, the inner membrane is set to polytetrafluoroethylene, the middle layer is set to a metal braided mesh, and the outer layer is set to a block polyetheramide elastomer. Of course, it should be known that the materials here are only used as examples and are not limitations of the present application. Based on the enlightenment of the present application, ordinary technicians in this field, other materials used are within the protection scope of the present application.

[0040] The self-resilient member 200 is made of a shape memory material and is movably disposed in the inner cavity of the guide assembly 100 . Two communicating limiting through holes 210 are disposed on the outer wall of the self-resilient member 200 near the proximal end.

[0041] Among them, Figure 4 , Figure 5 as well as Figure 7 As shown, the proximal outer diameter of the self-resilient member 200 is greater than the distal outer diameter thereof, and the self-resilient member 200 smoothly transitions from the proximal end to the distal end. Exemplarily, the proximal inner diameter of the self-resilient member 200 is preferably 5mm-7mm, and the wall thickness is preferably 0.1mm-0.5mm, and the distal outer diameter of the self-resilient member 200 is preferably 2mm-3mm, and the wall thickness is preferably 0.1mm-0.5mm. Specifically, in the natural state, the self-resilient member 200 is in the shape of a closed ring, that is, the distal end of the self-resilient member 200 is inserted into the limiting through hole 210 under the action of its own resilience to form a closed ring, and the diameter of the closed ring is adjusted in real time to shorten the effective length of the tendon cord. When the self-resilient member 200 is inserted into the inner cavity of the delivery catheter 110, at this time, under the restriction of the wall of the delivery catheter 110, the self-resilient member 200 will be forced to change from a closed ring to a straight state.

[0042] 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 arranged at the proximal end under the action of its own rebound force, preferably, the aperture of the limiting through hole 210 is larger than the distal outer diameter of the self-resilient member 200. Exemplarily, the aperture of the limiting through hole 210 is ≥4mm.

[0043] In a preferred embodiment, the self-resilient member 200 has an inner cavity and is made of a material with good biocompatibility and shape memory function, for example, nickel-titanium alloy. The self-resilient member 200 can be made of a nickel-titanium tube, or can be made of nickel-titanium tubes of different diameters. During production, it is preformed into a closed ring after heat treatment. The closed ring has a predetermined minimum diameter L1 and a maximum diameter L2 after adjustment, contraction and locking. Figure 4As shown, the minimum diameter L1 of the closed loop refers to the diameter of the initial state when the self-resilient member 200 rebounds into the closed loop. At this time, the diameter of the closed loop is the smallest, and the minimum diameter is 8 mm. The maximum diameter L2 of the closed loop refers to the diameter of the maximum state after the self-resilient member 200 rebounds into the closed loop and can be adjusted to be folded and locked. The maximum diameter is 15 mm, thereby ensuring the effective adjustment range of the tendon cord.

[0044] It should be noted that the above numerical range is set based on the fact that the diameter of the mitral valve ring is usually about 30 mm, and the chordae tendineae are basically regulated at 1 / 2 of the distance from the ring to the apex. When the diameter of the closed ring is greater than 15 mm, there is no contraction effect; when the diameter of the closed ring is less than 8 mm, it may cause stenosis of the valve orifice, thus affecting the surgical effect.

[0045] It can be understood that, optionally, the self-resilient member 200 includes a main body, which can be selected from a tubular structure or a rod-shaped structure, or can be a solid structure, but a channel and at least one regulating line 300 need to be reserved, which are passed through the inner cavity of the self-resilient member 200, and the regulating line 300 is movably connected to the distal end of the self-resilient member 200.

[0046] It is understandable that, optionally, the self-resilient member 200 can also be made of a composite of a dense structure or a mesh structure body and a polymer film or coating, wherein the body is made of shape memory materials such as nickel-titanium alloy by laser cutting or weaving, and after heat setting treatment, the outer surface of the body is at least partially coated with a biocompatible polymer film or coating such as PET or PTFE.

[0047] When the self-resilient member 200 extends from the distal inner cavity of the guide assembly 100, the distal end of the self-resilient member 200 is inserted into the limiting through hole 210 under the action of its own rebound force to form a closed loop for gathering the tendons, and the regulating line 300 is used to adjust the diameter of the closed loop.

[0048] In a specific embodiment, Figure 4 , Figure 8 as well as Fig.10 As shown, the regulating wire 300 is used to pull the distal end of the self-resilient member 200 back and forth to move toward or away from the insertion limit through hole 210 to adjust the diameter of the closed loop, thereby further adjusting the effective length of the gathered tendon cords. The number of regulating wires 300 is set to one or more. In this embodiment, in order to save costs, preferably, the number of regulating wires 300 is set to one. In order to facilitate the adjustment of the diameter of the self-resilient member 200, such as Figure 6As shown, preferably, at least one pair of regulating through holes 220 is provided at the distal end of the self-resilient member 200, and the regulating wire 300 passes through the regulating through holes 220 correspondingly along any free end, and each free end of the regulating wire 300 extends toward the proximal end along the axial direction of the self-resilient member 200. In this embodiment, the number of regulating through holes 220 is set to a pair, and the two regulating through holes 220 are adjacently arranged along the radial direction of the distal end of the self-resilient member 200. After a regulating wire 300 is bent into a "U" shape, the two free ends pass through the two regulating through holes 220 correspondingly, and then the two free ends extend toward the proximal end along the axial direction of the self-resilient member 200 until they extend out of the delivery catheter 110, so as to facilitate the use of the operator. Specifically, when it is necessary to further adjust the diameter of the closed loop, the operator only needs to hold the two free ends at the same time and pull the regulating wire 300 back and forth to adjust the diameter of the closed loop to a suitable position. When the regulating line 300 needs to be withdrawn, the operator only needs to hold any free end and pull it toward the proximal end until the regulating line 300 is completely withdrawn from the human body. The regulating line 300 can be selected from medical-grade PET line, multi-strand stainless steel line, and other medical-grade lines that do not cause damage to the human body, preferably 2-0PET suture.

[0049] The specific operation process of real-time regulation is as follows: after the tendon chord regulating device is delivered to the vicinity of the tendon chords, the guide assembly 100 is withdrawn proximally, at this time, the self-resilient member 200 will extend from the distal inner cavity of the guide assembly 100, and the distal end of the self-resilient member 200 is inserted into the limiting through hole 210 under the action of its own rebound force to form a closed loop, which gathers the tendon chords, thereby shortening the effective length of the tendon chords. If it is then observed under the action of an ultrasonic device that the mitral valve has not recovered to a fully closed state, at this time, it is only necessary to pull the regulating wire 300 back and forth toward the proximal end to adjust the diameter of the closed ring, thereby achieving real-time regulation of the effective length of the tendon chords; if it is observed that the mitral valve has recovered to a fully closed state, stop pulling and lock and fix it. In summary, the tendon chord regulating device of the present application can achieve real-time adjustment of the effective length of the tendon chords according to the state of the mitral valve, thereby ensuring the surgical effect.

[0050] According to a preferred embodiment of the present invention, in order to further ensure that the distal end of the self-resilient member 200 can be smoothly inserted into the limiting through hole 210 arranged at the proximal end under the action of its own resilience, as shown in FIG. Fig. 9 As shown, 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 forms an acute angle with the tube wall of the self-resilient member 200 .

[0051] According to one embodiment of the present invention, in order to lock the effective length that has been adjusted, as Figure 8-Figure 13As shown, the inner cavity of the self-resilient member 200 is further provided with a locking structure 400 , and the locking structure 400 is used to lock the distal end of the self-resilient member 200 inserted into the limiting through hole 210 .

[0052] Specifically, the locking structure 400 includes: a locking plate 410, one end of which is connected to the inner wall surface of the self-resilient component 200 and close to the proximal end of the limiting through hole 210, and the other end is a free end and at least one locking control line 420, which is passed through the inner cavity of the self-resilient component 200, and the locking control line 420 is movably connected to the locking plate 410.

[0053] In a specific embodiment, Fig.11 As shown, the locking piece 410 is made of a material with good biocompatibility and shape memory function. Exemplary, it is nickel-titanium alloy, etc. And the width of the locking piece 410 should not be too narrow or too short, otherwise the locking force on the effective length of the tendon will be insufficient due to insufficient tension of the locking piece; at the same time, too wide or too long will easily interfere with the regulating line 300 and the locking control line 420. Therefore, the ratio between the width of the locking piece 410 and the proximal inner diameter of the self-rebounding member 200 is 1 / 3-2 / 3, preferably 1 / 2. The ratio between the length of the locking piece 410 and the proximal inner diameter of the self-rebounding member 200 is 1 / 3-3 / 4, preferably 2 / 3, so as to ensure that the locking effect of the effective length of the tendon is ensured while not interfering with the regulating line 300 and the locking control line 420.

[0054] like Figure 5 , Fig. 9 , Fig.10 , Fig.11 as well as Fig.12 As shown, the locking control line 420 is used to drive the free end of the locking plate 410 to move toward the distal direction of the self-resilient member 200 to lock the self-resilient member 200, and the locking control line 420 is used to drive the free end of the locking plate 410 to move away from the distal direction of the self-resilient member 200 to release the self-resilient member 200. The number of locking control lines 420 is set to one or more. In this embodiment, in order to save costs, preferably, the number of locking control lines 420 is set to one. In order to facilitate the regulation of the distal end of the self-locking plate 410, such as Fig.11As shown, preferably, at least one pair of locking through holes 411 is provided on the free end of the locking plate 410, and the locking control line 420 passes through the locking through holes 411 correspondingly along any free end, and each free end of the locking control line 420 extends from the locking plate 410 to the proximal end along the axial direction. In this embodiment, the number of locking through holes 411 is set to a pair, and the two locking through holes 411 are adjacently arranged along the distal radial direction of the self-resilient member 200. After a locking control line 420 is bent into a "U" shape, the two free ends pass through the two locking through holes 411 correspondingly, and then the two free ends extend from the locking plate 410 to the proximal end along the axial direction until they extend out of the delivery catheter 110, so as to facilitate the use by the operator. Specifically, when the self-resilient member 200 extends from the distal inner cavity of the guide assembly 100, on the one hand, the operator holds the two free ends at the same time and pulls the locking control line 420 toward the proximal end, thereby driving the locking plate 410 to move toward the proximal end synchronously to release the self-resilient member 200. At the same time, on the other hand, due to the interaction between the locking control line 420 and the pulled end of the locking plate 410, the locking control line 420 will generate a force in the opposite direction to the control line 300, and this force will fix the proximal end of the self-resilient member 200 when the control line 300 is pulled, thereby further realizing the free movement of the distal end of the self-resilient member 200 in the limiting through hole 210 by pulling the control line 300, so as to achieve real-time adjustment of the closed loop diameter, thereby achieving real-time adjustment of the effective length of the tendon cord. Finally, if it is observed that the current effective length of the tendon cord is the required effective length, the operator only needs to hold any free end of the locking control line 420 and pull it toward the proximal end until the locking control line 420 is completely withdrawn from the human body. Figure 5 As shown, under the action of its own resilience, the free end of the locking piece 410 will move toward the distal end of the self-resilient member 200 until it contacts the distal end of the self-resilient member 200 to lock the self-resilient member 200, thereby locking the current effective length of the tendon cord. The locking control line 420 can be selected from medical-grade PET line, multi-strand stainless steel line, and other medical-grade lines that do not cause damage to the human body, preferably 2-0PET suture.

[0055] According to an embodiment of the present invention, the free end of the locking sheet 410 is bent at a preset angle toward the direction close to the limiting through hole 210. Specifically, during processing, the locking sheet 410 is in a flat sheet shape in a natural state, and is preformed into a Fig.11 The sheet is bent toward the limiting through hole 210 , and the bending angle is an acute angle, so as to further increase the elastic force of the locking sheet 410 , and further enhance the locking ability of the locking sheet 410 to the far end of the self-resilient member 200 .

[0056] According to one embodiment of the present invention, in order to further 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 its own resilience, as shown in FIG. Figure 5 , Fig. 9 , Fig.10 , Fig.12 as well as Fig.13 As shown, the inner cavity of the self-resilient member 200 is further provided with a wire guide 500, which is disposed in the inner cavity of the self-resilient member 200. The wire guide 500 is fixedly connected to the inner side wall of the self-resilient member 200 and is staggered with the limiting through hole 210. The regulating wire 300 passes through the inner cavity of the wire guide 500. Fig.10 and Fig.12 As shown, the wire guide 500 designed in this embodiment can accommodate the regulating wire 300 corresponding to the limiting through hole 210 in the wire guide 500, thereby ensuring that the distal end of the self-resilient member 200 can be more smoothly inserted into the limiting through hole 210 set at the proximal end under the action of its own rebound force.

[0057] Specifically, Fig.12 and 13 As shown, the guide wire 500 is a hollow flat tube as a whole. Preferably, the length of the guide wire 500 is greater than or equal to the axial length of the limiting through hole 210. Exemplarily, the length range of the guide wire 500 is: 10mm-20mm, the wall thickness range of the guide wire 500 is 0.2-0.4mm, and the inner cavity width range of the guide wire 500 is 0.5mm-1mm. Among them, the guide wire 500 is made of a rigid or semi-rigid material with good biocompatibility, and exemplary, PEEK, SUS316L, NiTi, etc. are used.

[0058] According to one embodiment of the present invention, Figure 1 As shown, the tendon control device also includes a push tube 600, which is detachably connected to the proximal end of the self-resilient member 200. Specifically, the push tube 600 is movably arranged in the inner cavity of the delivery catheter 110 via the delivery handle 120, and can be detachably connected to the proximal end of the self-resilient member 200 by means of sleeve connection, clamping or threaded connection. When an abnormal situation occurs or the release position of the self-resilient member 200 is not ideal, the self-resilient member 200 is allowed to be withdrawn into the delivery catheter 110 through the push tube 600, thereby realizing the retraction operation. Among them, the push tube 600 is made of a rigid material with a certain flexibility, and exemplarily, nickel-titanium alloy is used, and the inner and outer diameters of the push tube 600 are kept consistent with the proximal end of the self-resilient member 200, which is convenient for the delivery operation.

[0059] The operation steps of this embodiment are described below in conjunction with the accompanying drawings:

[0060] Step 1: If Fig.14As shown, the chordae tendineae regulating device of the present application is delivered to the vicinity of the chordae tendineae of the mitral valve via the femoral artery - abdominal aorta - thoracic aorta - aortic valve orifice in sequence.

[0061] Step 2: If Fig.15 As shown, under the action of the push tube 600, the self-resilient member 200 is pushed out of the distal inner cavity of the guide assembly 100 to a certain length. At this time, the distal end of the self-resilient member 200 begins to retract around the tendinous cord under the action of its own resilience.

[0062] Step 3: If Fig.16 As shown, the push tube 600 is continuously driven until the self-resilient member 200 is completely pushed out of the distal inner cavity of the guide assembly 100. At this time, the distal end of the self-resilient member 200 is inserted into the limiting through hole 210 under the action of its own resilience to form a closed loop for gathering the tendons. Under the action of the ultrasonic device, the diameter of the closed loop is adjusted by pulling the regulating wire 300 back and forth. When the current mitral valve closure state is observed to be the expected state through the ultrasonic device, the free end of the locking plate 410 is driven by the locking control wire 420 to move toward the distal direction of the self-resilient member 200 to lock the self-resilient member 200, thereby locking the above-mentioned adjusted closed loop diameter and then locking the effective length of the current tendons.

[0063] Step 4: If Fig.17 As shown, a free end of the proximal end of the locking control line 420 and a free end of the proximal end of the regulating line 300 are pulled out respectively to achieve separation from the self-resilient member 200, thereby completing the release operation of the self-resilient member 200.

[0064] Step 5: If Fig.18 As shown, the delivery tube is finally withdrawn from the human body, and the surgical operation is completed.

[0065] The above is only a specific embodiment of the present invention, so that those skilled in the art can understand or implement the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but should conform to the widest scope consistent with the principles and novel features applied herein.

Claims

1. A tendon chord regulating device, characterized in that: include: a guide assembly having an inner cavity; A self-resilient member is made of a shape memory material, and is movably disposed in the inner cavity of the guide assembly. The outer wall of the self-resilient member near the proximal end is provided with two communicating limiting through holes, and the aperture of the limiting through holes is larger than the outer diameter of the distal end of the self-resilient member; At least one regulating wire is passed through the inner cavity of the self-resilient member, and the regulating wire is movably connected to the distal end of the self-resilient member; When the self-resilient member extends out of the distal inner cavity of the guide assembly, the distal end of the self-resilient member is inserted into the limiting through hole under the action of its own resilience to form a closed loop for gathering the tendon cords, and the regulating wire is used to adjust the diameter of the closed loop; and The locking structure comprises: A locking plate, one end of which is connected to the inner wall surface of the self-resilient member and close to the proximal end of the limiting through hole, and the other end of which is a free end; and At least one locking control line is passed through the inner cavity of the self-resilient member, and the locking control line is movably connected to the locking plate; The locking control line is used to drive the free end of the locking plate to move in the distal direction of the self-resilient component to lock the self-resilient component, and the locking control line is used to drive the free end of the locking plate to move in the distal direction away from the self-resilient component to release the self-resilient component.

2. The tendon chord regulating device according to claim 1, characterized in that: The self-resilient member smoothly transitions from the proximal end to the distal end.

3. The tendon chord regulating device according to claim 1, characterized in that: The centers of the two limiting through holes are staggered.

4. The tendon chord regulating device according to claim 1, characterized in that: The distal end of the self-resilient member is provided with at least one pair of regulating through holes, and the regulating wire passes through the regulating through holes correspondingly along any free end, and each free end of the regulating wire extends toward the proximal end along the axial direction of the self-resilient member.

5. The tendon chord regulating device according to claim 1, characterized in that: At least one pair of locking through holes is provided on the free end of the locking plate, and the locking control line passes through the locking through holes correspondingly along any free end, and each free end of the locking control line extends toward the proximal end along the axial direction of the self-resilient member.

6. The tendon chord regulating device according to claim 1, characterized in that: The ratio between the width of the locking piece and the inner diameter of the proximal end of the self-resilient member is 1 / 3-2 / 3, and the ratio between the length of the locking piece and the inner diameter of the proximal end of the self-resilient member is 1 / 3-3 / 4.

7. The tendon chord regulating device according to claim 1, characterized in that: The free end of the locking sheet is bent in a direction close to the limiting through hole, and the bending angle is an acute angle.

8. The tendon chord regulating device according to claim 1, characterized in that: The inner cavity of the self-resilient component is also provided with a wire guide, which is arranged in the inner cavity of the self-resilient component, fixedly connected to the inner wall of the self-resilient component and staggered with the limiting through hole, and the regulating wire passes through the inner cavity of the wire guide.

9. The tendon chord regulating device according to claim 8, characterized in that: The length of the wire guide is greater than or equal to the axial length of the limiting through hole.

10. The tendon chord regulating device according to claim 1, characterized in that: The tendon cord regulating device also includes a push tube, which is detachably connected to the proximal end of the self-resilient member.

11. The tendon chord regulating device according to claim 10, characterized in that: The guide assembly comprises: a delivery catheter and a delivery handle sleeved on the outside of the delivery catheter, and the self-rebounding member and the push tube are both movably inserted into the inner cavity of the delivery catheter via the delivery handle.

12. The tendon chord regulating device according to claim 1, characterized in that: The diameter of the closed loop ranges from 8 mm to 15 mm.

13. The tendon chord regulating device according to claim 1, characterized in that: The self-resilient member comprises a body, and the body is selected from a tubular structure or a rod-shaped structure, and the tubular structure or the rod-shaped structure is a dense structure or a mesh structure.

14. The tendon chord regulating device according to claim 13, characterized in that: A biocompatible polymer film or a biocompatible coating is applied on at least a portion of the outer surface of the body.

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