A replacement system for a retractable tendon

Abstract

The application relates to the field of medical devices, in particular to a replacement system capable of lifting chordae tendineae, which comprises an expandable stent, a valve clamping fixing device cooperatively operated with the expandable stent, an artificial valve leaflet configured in the expandable stent to replace the function of an autologous valve leaflet, and a clamping mechanism and a hoop element configured to clamp the autologous valve leaflet, wherein the valve clamping fixing device comprises the clamping mechanism, the hoop element and a connecting structure, the hoop element is connected with the clamping mechanism through the connecting structure, and the connecting structure can adaptively adjust the relative position of the hoop element and the clamping mechanism according to the pulling strength of the chordae tendineae tissue on the hoop element; in the application, the hoop element can pull the chordae tendineae to lift the autologous valve leaflet, avoid outflow tract obstruction, and avoid excessive pulling of the chordae tendineae, thereby solving two technical pain points in the treatment of mitral valve replacement surgery, and having good clinical significance.

Description

[0001] Cross-reference to related applications: This application claims priority to patent application CN202111164164.4, filed on September 30, 2021, the disclosure of which is incorporated herein by reference. Technical Field

[0002] This application relates to the field of medical devices, specifically to a chordae tendineae replacement system. Background Technology

[0003] Due to the unique physiological structure of the mitral valve, product positioning and anchoring present numerous technical challenges. Existing products mostly employ radial support of the autologous valve annulus during anchoring, which severely compresses surrounding valve tissue, leading to numerous postoperative complications. Furthermore, after replacement, the anterior leaflet of existing stents adheres to the stent's periphery and obstructs the left ventricular outflow tract, severely impacting aortic valve blood flow.

[0004] Existing patent CN202111164164.4 discloses an artificial valve replacement system, including: an expandable stent; and a valve clamping and fixing device cooperating with the expandable stent. The valve clamping and fixing device includes a clamping mechanism configured to clamp the autologous valve leaflet and a clamping member, the clamping member being configured to be connected to the clamping mechanism. The valve clamping and fixing device is configured to present a first form and a second form. When the valve clamping and fixing device is in the first form, the clamping mechanism is configured to capture and clamp the autologous valve leaflet. When the valve clamping and fixing device is in the second form, the expandable stent is in a radially expanded state. The radial expansion of the expandable stent causes the clamping member to shift upward and tighten the expandable stent, thereby pulling the autologous valve leaflet upward and folding it back. Although this technical solution can avoid the anterior leaflet obstructing the left ventricular outflow tract, when the clamping member pulls on the chordae tendineae, in areas where the chordae tendineae tissue is dense, it is easy to damage the chordae tendineae tissue, or even tear the chordae tendineae, thereby affecting the function of the autologous valve.

[0005] In conclusion, although the above technologies have achieved some clinical success, they all have shortcomings, and there is an urgent need for a new transcatheter heart valve replacement system to solve these problems. Summary of the Invention

[0006] In view of the above and other concepts, this application is made. The main purpose of this application is to overcome some problems and shortcomings of the prior art.

[0007] In terms of applications in atrioventricular valve surgery, this application aims to provide a chordae tendineae replacement system that can pull the chordae tendineae for patients with atrioventricular valve lesions who require interventional treatment, thereby solving the problem of excessive traction on the chordae tendineae tissue caused by existing heart valve replacement systems, leading to chordae tendineae tissue rupture.

[0008] According to one aspect of this application, a chordae tendineae replacement system is provided, comprising an expandable support and a flap clamping device cooperating with the expandable support. The expandable support is provided with an artificial flap for replacing the function of an autologous flap. The flap clamping device includes a clamping mechanism, a clamping member, and a connecting structure. The clamping member is connected to the clamping mechanism through the connecting structure, and the connecting structure allows the relative position of the clamping member and the clamping mechanism to be adaptively adjusted according to the force exerted by the chordae tendineae tissue on the clamping member.

[0009] As a further improvement of the present invention, the expandable stent is provided with an artificial leaflet, which can be made of biological materials such as bovine pericardium or porcine pericardium, or it can be made of polymer materials.

[0010] As a further improvement of the present invention, after the expandable bracket is installed in place, the force of the clamp member pulling the chordae tendineae tissue is balanced with the force of the chordae tendineae tissue pulling the clamp member.

[0011] As a further improvement of the present invention, when the force of the chordae tendineae pulling the clamp is greater than the force of the clamp lifting the chordae tendineae, the clamp moves toward the apex of the heart; when the force of the chordae tendineae pulling the clamp is less than the force of the clamp lifting the chordae tendineae, the chordae tendineae is lifted upward by the clamp and drives the autologous valve leaflet to be lifted upward.

[0012] As a further improvement of the present invention, the connection structure is an elastic element, and the clamping member is connected to the clamping mechanism through the elastic element.

[0013] As a further improvement of the present invention, the stroke of the elastic element varies according to the torque of the tendon tissue pulling the clamping member.

[0014] As a further improvement of the present invention, the connecting structure is a slider, and the clamping mechanism is provided with a slide rail that cooperates with the slider, and the clamping member is fixedly connected to the slider.

[0015] As a further improvement of the present invention, after the expandable support is installed in place, the clamping member pulls the chordae tendineae tissue and lifts the autologous flap leaflet, the autologous flap leaflet and the chordae tendineae tissue are clamped between the expandable support and the flap clamping device, and the clamping member tightens the expandable support.

[0016] As a further improvement of the present invention, the clamping member is a closed-loop structure or the clamping member cooperates with the clamping mechanism to form a closed-loop structure, and the clamping member is a rigid component.

[0017] As a further improvement of the present invention, the expandable support and the flap fixing device are an integral structure, the flap fixing device further includes a control wire, the clamping mechanism includes a first clamping arm and a second clamping arm, the control wire is detachably connected to the first clamping arm and the second clamping arm respectively, and pulling the control wire causes the first clamping arm and the second clamping arm to open and capture the autologous flap.

[0018] As a further improvement of the present invention, the expandable support and the clamping valve fixing device are separate structures, the distal end of the clamping mechanism is detachably connected, and in the first form, the valves around the clamping mechanism can open and close autonomously. When the expandable support enters the clamping mechanism, the distal end of the clamping mechanism is disassembled, and the expandable support is in a radially expanded state. The radial expansion of the expandable support causes the clamping member to move its own valve upward and clamp the expandable support.

[0019] As a further improvement of the present invention, the clamping member and part of the clamping mechanism are covered with a fabric layer; this design can effectively increase the friction of the clamping member and clamping mechanism on the self-petal leaflet.

[0020] As a further improvement of the present invention, the valve prosthesis further includes a sealing device, the sealing device including an adaptive segment and an abutment segment, the adaptive segment including a first arc segment, a second arc segment and a leak-proof membrane, the first arc segment being connected to the expandable stent, and the expandable stent providing a fulcrum for the first arc segment, after the expandable stent is installed in place, at least a portion of the first arc segment is in contact with the atrial wall, when the atrial wall compresses the first arc segment, the first arc segment rotates around the fulcrum toward the center of the expandable stent, and the first arc segment drives the second arc segment to rotate in the same direction.

[0021] As a further improvement of the present invention, when the heart valve prosthesis is used for mitral valve treatment, the adaptive segment is located in the anterior leaflet region and the abutment segment is located in the posterior leaflet region.

[0022] Compared with the prior art, the advantages and beneficial technical effects of this application include at least the following: 1. While existing replacement systems can use clamps to lift the chordae tendineae, thereby raising the autologous valve leaflet and preventing obstruction of the left ventricular outflow tract, these clamps are prone to overstretching the chordae tendineae tissue, causing damage or even rupture. In one embodiment of this application, after traction on the chordae tendineae tissue, the clamp can adjust the relative position of the clamp and the clamping mechanism according to the tension between the chordae tendineae tissue and the clamp. That is, when the chordae tendineae tissue is overstretched, the clamp can move downwards relative to it, so that the clamp and the chordae tendineae tissue achieve a force balance, effectively preventing the clamp from overstretching the chordae tendineae tissue and causing damage or even rupture. At the same time, the clamp can lift the chordae tendineae and further raise the autologous valve leaflet, preventing obstruction of the left ventricular outflow tract and reducing postoperative complications.

[0023] 2. In one embodiment of this application, a clamping mechanism is used to bring the clamping member to a position below the autologous valve leaflet, and further manipulation is performed to position the clamping member between the chordae tendineae tissue and the autologous valve leaflet. When the expandable stent expands radially, the clamping member is tensioned and pulls the chordae tendineae, causing the autologous valve leaflet to be pulled upward, thus preventing the autologous valve leaflet from blocking the outflow tract after the expandable stent is implanted. At the same time, the radial expansion of the expandable stent and its cooperation with the clamping member ultimately clamp the autologous valve leaflet and chordae tendineae tissue between the expandable stent and the clamping member. This anchoring method can prevent the expandable stent from significantly expanding the autologous valve annulus radially, avoid compressing and excessively pulling the original tissue of the heart, reduce postoperative complications, and solve two major technical pain points in the prior art regarding mitral valve replacement treatment, which has great clinical significance.

[0024] The embodiments of this application can achieve other beneficial technical effects not listed one by one. These other technical effects may be partially described below and can be expected and understood by those skilled in the art after reading this application. Attached Figure Description

[0025] The above-described features and advantages, as well as other features and advantages, and the ways in which they are implemented, of these embodiments will become more apparent and the embodiments of this application will be better understood by referring to the following description in conjunction with the accompanying drawings, in which: Figures 1a-1d This is a schematic diagram of the expandable support and clamp fixation device of the present invention.

[0026] Figure 2a and 2b This is a schematic diagram of the sealing device of the present invention.

[0027] Figures 3a-3d This is a schematic diagram of the entry route of the conveying device of the present invention.

[0028] Figures 4a-4e This is one embodiment of the present invention, in which the expandable support and the clamp fixing device are separate structures.

[0029] Figure 5a and 5b This is another embodiment of the connection structure of the present invention.

[0030] The parts referred to by the numbers in the attached diagram are as follows: 1-Expandable support, 2-Clamping valve fixing device, 21-Clamping mechanism, 211-First clamping arm, 212-Second clamping arm, 22-Clamping clamp, 23-Connecting structure, 231-Elastic element, 232-Slider, 233-Slide rail, 24-Control wire, 3-Artificial valve leaflet, 4-Sealing device, 41-Adaptive section, 411-First arc-shaped section, 412-Second arc-shaped section, 413-Leak-proof membrane, 42-Abutting section, 5-Conveying device, 6-First conveying system, 61-Inner core tube, 7-Second conveying system. Detailed Implementation

[0031] The details of one or more embodiments of this application will be set forth in the following description of the accompanying drawings and specific embodiments. Other features, objects, and advantages of this application will become clear from these descriptions, drawings, and claims.

[0032] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments may be other embodiments and can be implemented or performed in various ways. The examples are provided by way of explanation rather than limitation of the disclosed embodiments. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of this application without departing from the scope or spirit of this disclosure. For example, features illustrated or described as part of one embodiment may be used with another embodiment to still produce another embodiment. Therefore, this disclosure covers such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0033] Similarly, it is understood that the phrases and terms used in this document are for descriptive purposes and should not be considered restrictive. The use of “including,” “contains,” or “has,” and their variations, in this document is intended to include, in an open-ended manner, the items listed thereafter and their equivalents, as well as any possible additional items.

[0034] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0035] In this application, the proximal end refers to the end closest to the apex of the heart, and the distal end refers to the end furthest from the apex of the heart. Specific implementation examples: Example 1: like Figures 1a-1cAs shown, when the valve prosthesis is used for mitral valve treatment, in this embodiment, a chordae tendineae replacement system includes an expandable stent 1 and a valve clamping and fixing device 2 that operates in conjunction with the expandable stent 1. The expandable stent 1 is equipped with an artificial leaflet 3 for replacing the function of the autologous leaflet (the artificial leaflet 3 can be made of biomaterials such as bovine pericardium or porcine pericardium, or it can be made of polymer materials). The expandable stent 1 and the valve clamping and fixing device 2 are an integral structure. The valve clamping and fixing device 2 includes a clamping mechanism 21, a clamping member 22, a connecting structure 23, and a control wire 24. The clamping member 22 is connected to the clamping mechanism 21 through the connecting structure 23. The clamping mechanism 21 includes a first clamping arm 211 and a second clamping arm 212. The control wire 24 is connected to the first clamping arm 211 and the second clamping arm 212, respectively. The two clamping arms 212 are disassembled and connected. Pulling the control wire 24 causes the first clamping arm 211 and the second clamping arm 212 to open and capture the autologous leaflet. The clamping member 22 will be positioned between the chordae tendineae and the autologous leaflet. When the expandable support 1 expands radially, the clamping member 22 tensions and lifts the chordae tendineae tissue. Furthermore, the connecting structure 23 allows the relative position of the clamping member 22 and the clamping mechanism 21 to be adaptively adjusted according to the force of the chordae tendineae tissue pulling the clamping member 22. For example, when the force of the chordae tendineae tissue pulling the clamping member 22 is greater than the force of the clamping member 22 lifting the chordae tendineae tissue, the clamping member 22 moves towards the apex of the heart; when the force of the chordae tendineae tissue pulling the clamping member 22 is less than the force of the clamping member 22 lifting the chordae tendineae tissue, the chordae tendineae tissue is lifted upward by the clamping member 22, which in turn lifts the autologous leaflet.

[0037] In this embodiment, after the expandable bracket 1 is installed in place, the force of the clamp 22 pulling the chordal tissue is balanced by the force of the chordal tissue pulling the clamp 22. Figure 1d As shown.

[0038] In this embodiment, the connecting structure 23 is an elastic element 231, and the clamping member 22 is connected to the clamping mechanism 21 through the elastic element 231, as shown below. Figure 1b and 1c As shown.

[0039] In this embodiment, the stroke of the elastic element 231 varies according to the torque of the tendon tissue pulling the clamp 22.

[0040] In this embodiment, after the expandable support 1 is installed in place, the clamp 22 pulls the chordae tendineae tissue and lifts the autologous flap leaflet. The autologous flap leaflet and chordae tendineae tissue are clamped between the expandable support 1 and the flap clamping and fixing device 2, and the clamp 22 tightens the expandable support 1.

[0041] In this embodiment, the clamping member 22 is a closed-loop structure or the clamping member 22 cooperates with the clamping mechanism 21 to form a closed-loop structure, and the clamping member 22 is a rigid component.

[0042] In this embodiment, the clamping member 22 and part of the clamping mechanism 21 are covered with a fabric layer; this design can effectively increase the friction of the clamping member 22 and the clamping mechanism 21 on the self-petal leaflet.

[0043] In this embodiment, the valve prosthesis further includes a sealing device 4, which includes an adaptive segment 41 and a contacting segment 42, such as... Figure 2a and 2b As shown, the adaptive segment 41 includes a first arc segment 411, a second arc segment 412, and a leak-proof membrane 413. The first arc segment 411 is connected to the expandable stent 1, and the expandable stent 1 provides a fulcrum for the first arc segment 411. After the expandable stent 1 is installed in place, at least part of the first arc segment 411 is in contact with the atrial wall. When the atrial wall compresses the first arc segment 411, the first arc segment 411 rotates around the fulcrum toward the center of the expandable stent 1, and the first arc segment 411 drives the second arc segment 412 to rotate in the same direction.

[0044] In this embodiment, the replacement system further includes a delivery device 5 for delivering it to the surgical site.

[0045] An exemplary procedure for repairing a mitral valve using the chordae tendineae replacement system of this embodiment is as follows: 1. Operate the conveying device 5 from the apex of the passage, as follows: Figure 3a and 3b As shown, the distal portion of its delivery device 5 is located within the left atrium, as... Figure 3c As shown; 2. Operate the conveying device 5 to release the distal portion of the expandable support 1. At this time, the sealing device 4 is not yet fully released. Pull the control wire 24 to open the first clamping arm 211 and the second clamping arm 212 and capture the autologous leaflet, as shown. Figure 3c and 3d As shown; 3. When the first clamping arm 211 and the second clamping arm 212 are located behind the anterior and posterior leaflets respectively, and the clamping member 22 is between the autologous leaflet and the chordae tendineae tissue, the delivery device 5 is further operated so that the sealing device 4 is completely released and supported in the left atrium. 4. Operate the delivery device 5 to release the proximal portion of the expandable stent 1 until the expandable stent 1 is fully radially expanded and engages with the clamp 22, ultimately securing the autologous flap leaflet and chordal tissue between the expandable stent 1 and the clamp 22. Then, remove the delivery device 5 to complete the implantation. Figure 1d As shown.

[0046] Example 2: Example 2 is largely the same as Example 1, except that the expandable support 1 and the clamping device 2 are separate structures.

[0047] In this embodiment, the expandable support 1 and the clamping valve fixing device 2 are separate structures. The distal end of the clamping mechanism 21 is detachably connected. In the first state, the valves around the clamping mechanism 21 can open and close autonomously. When the expandable support 1 enters the clamping mechanism 21, the distal end of the clamping mechanism 21 is disassembled, and the expandable support 1 is in a radially expanded state. The radial expansion of the expandable support 1 causes the clamping member 22 to move its own valve upward and clamp the expandable support 1.

[0048] In this embodiment, the clamping and fixing device 2 is transported by the first conveying system 6, such as... Figure 4a As shown, the expandable support 1 is conveyed by the second conveying system 7, such as... Figure 4c As shown, the first delivery system 6 includes an inner core tube 61. The distal end of the inner core tube 61 can control the distal end of the clamping mechanism 21 for disassembly and connection. Furthermore, the inner core tube 61 can serve as a guide for the second delivery system 7. During the operation, the first delivery system 6 is used to deliver the valve clamping device 2 into the body. After the valve clamping device 2 is installed in place, the second delivery system 7 enters the heart along the inner core tube 61 and releases the expandable stent 1 to complete the implantation.

[0049] An exemplary procedure for repairing a mitral valve using a chordae tendineae replacement system according to Embodiment 2 is as follows: 1. First, the first delivery system 6 is delivered to the left heart via the inferior vena cava and through the interatrial septum. Then, the clamping mechanism 21 is released to capture the autologous valve leaflet. After the clamping mechanism 21 captures the autologous valve leaflet, only the inner core tube 61 of the first delivery system 6 remains in the body. Figure 4a and 4b As shown; 2. The second delivery tube is inserted into the core along the path of the inner core tube 61, as follows: Figure 4c and 4d As shown, when the expandable support 1 is observed to be in the middle position of the clamping mechanism 2121, the inner core tube 61 is removed and the expandable support 1 is released. 3. The expandable scaffold 1 expands radially and engages with the clamp 22, ultimately securing the autologous flap and chordae tendineae tissue between the expandable scaffold 1 and the clamp 22. The delivery device 5 is then removed, completing the implantation. Figure 4e As shown.

[0050] In this regard, the relevant construction and concept of Embodiment 2 are similar to those of Embodiment 1, and therefore will not be described again here.

[0051] Example 3: Example 3 is largely the same as Example 1, except that in this example, the connecting structure 23 is in the form of a slider 232 and a slide rail 233.

[0052] In this embodiment, the connecting structure 23 is a slider 232, such as Figure 5a As shown, the clamping mechanism 21 is provided with a slide rail 233 that cooperates with the slider 232, and the clamping member 22 is fixedly connected to the slider 232, as shown. Figure 5b As shown; the connecting structure 23 allows the relative position of the clamping member 22 and the clamping mechanism 21 to be adaptively adjusted according to the force exerted by the chordae tendineae on the clamping member 22. For example, when the force exerted by the chordae tendineae on the clamping member 22 is greater than the force exerted by the clamping member 22 on the chordae tendineae, the slider 232 moves along the slide rail 233 toward the apex of the heart; when the force exerted by the chordae tendineae on the clamping member 22 is less than the force exerted by the clamping member 22 on the chordae tendineae, the slider 232 moves along the slide rail 233 toward the atrium, and the chordae tendineae are lifted upward by the clamping member 22, which in turn lifts the autologous valve leaflet.

[0053] In this regard, the relevant construction and concept of Embodiment 3 are similar to those of Embodiment 1, and therefore will not be described again here.

[0054] The foregoing description of exemplary embodiments of this application has been provided for illustrative purposes. The foregoing description is not intended to be exhaustive, nor is it intended to limit this application to the precise configurations and / or constructions disclosed. Clearly, many modifications and variations can be made by those skilled in the art based on the teachings above without departing from the invention. The scope and equivalents of this invention are intended to be defined by the appended claims.

Claims

1. A chordae tendineae replacement system, comprising an expandable scaffold and a flap clamping device cooperating with the expandable scaffold, wherein the expandable scaffold is provided with an artificial flap for replacing the function of an autologous flap, characterized in that: The clamping and fixing device includes a clamping mechanism, a clamping member, and a connecting structure. The clamping member is connected to the clamping mechanism through the connecting structure, and the connecting structure allows the relative position of the clamping member and the clamping mechanism to be adaptively adjusted according to the force exerted by the chordae tendineae on the clamping member. The connecting structure is an elastic element, and the clamping member is connected to the clamping mechanism through the elastic element. Alternatively, the connecting structure is a slider, and the clamping mechanism is provided with a slide rail that cooperates with the slider, and the clamping member is fixedly connected to the slider.

2. The chordae tendineae replacement system according to claim 1, characterized in that: After the expandable bracket is installed in place, the force of the clamp pulling the chordae tendineae is balanced by the force of the chordae tendineae pulling the clamp.

3. The chordae tendineae replacement system according to claim 2, characterized in that: When the force exerted by the chordae tendineae on the clamp is greater than the force exerted by the clamp on the chordae tendineae, the clamp moves toward the apex of the heart; when the force exerted by the chordae tendineae on the clamp is less than the force exerted by the clamp on the chordae tendineae, the chordae tendineae are pulled upward by the clamp and drive the autologous valve leaflet upward.

4. The chordae tendineae replacement system according to claim 1, characterized in that: The stroke of the elastic element varies according to the torque exerted by the chordae tendineae on the clamping element.

5. The chordae tendineae replacement system according to claim 1, characterized in that: After the expandable support is installed in place, the clamping member pulls the chordae tendineae tissue and lifts the autologous flap leaflet. The autologous flap leaflet and chordae tendineae tissue are clamped between the expandable support and the flap clamping device, and the clamping member tightens the expandable support.

6. The chordae tendineae replacement system according to claim 1, characterized in that: The clamping member is a closed-loop structure or the clamping member cooperates with the clamping mechanism to form a closed-loop structure, and the clamping member is a rigid component.

7. The chordae tendineae replacement system according to claim 1, characterized in that: The expandable support and the flap fixing device are an integral structure. The flap fixing device also includes a control wire. The clamping mechanism includes a first clamping arm and a second clamping arm. The control wire is detachably connected to the first clamping arm and the second clamping arm respectively. Pulling the control wire causes the first clamping arm and the second clamping arm to open and capture the autologous flap.

8. The chordae tendineae replacement system according to claim 1, characterized in that: The expandable support and the clamping valve fixing device are separate structures. The distal end of the clamping mechanism is detachably connected. In the first state, the valves around the clamping mechanism can open and close autonomously. When the expandable support enters the clamping mechanism, the distal end of the clamping mechanism is disassembled, and the expandable support is in a radially expanded state. The radial expansion of the expandable support causes the clamping member to move its own valve upward and clamp the expandable support.

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