Artificial valve anchoring device

Abstract

The utility model provides an artificial valve anchoring device which comprises two clamping arms connected with each other and a carrying arm connected between the two clamping arms, and any clamping arm comprises a clamping part, an opening and closing part and a transition part which are connected with each other. The clamping parts on the two clamping arms are arranged in a crossed manner, so that a clamping space with an opening is formed between the two clamping parts; after the artificial valve anchoring device reaches a designated position and is released, in the valve expansion process, the intersection position of the clamping parts on the two clamping arms is changed so that the clamping space between the clamping parts can be reduced, and the native valve leaflet in the clamping space can be clamped. Under the condition that a valve smaller than a valve ring is selected, anchoring can still be well achieved, displacement of the valve is avoided, and the risk of perivalvular leakage can be effectively reduced by clamping reflux holes of adjacent valve leaflets through the artificial valve anchoring device.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to an artificial valve anchoring device. Background Technology

[0002] Heart valves are the fundamental structure of the heart, and severe valvular disease can lead to death. Heart valves can develop conditions such as insufficiency (regurgitation) and stenosis due to congenital or acquired inflammation. Transcatheter aortic valve replacement (TAVR), as a safe and effective minimally invasive interventional treatment, has become a first-line treatment for elderly patients with aortic stenosis (AS). TAVR was initially used to treat AS and has since been extended to treat aortic regurgitation (AR). However, AR patients have different anatomical structures, valve selection, surgical procedures, and complications compared to AS patients.

[0003] Some AR patients have large valve annulus, dilated left ventricular outflow tract (LVOT), non-calcified stenotic supravalvular anchoring area, and lack of anchoring anatomy at the junction of LVOT and sinus duct. The valve cannot withstand the strong diastolic blood flow pressure, making TAVR valve anchoring difficult and prone to displacement. Utility Model Content

[0004] Therefore, the technical problem to be solved by this utility model is that in the prior art, TAVR valve anchoring is difficult, it is easy to shift, and regurgitation is easy to occur at the junction of adjacent valves.

[0005] Therefore, this utility model provides an artificial valve anchoring device, comprising:

[0006] At least two interconnected clamping arms, each of the clamping arms including a clamping portion, and the clamping portions on the two clamping arms are intersecting to form a clamping space between the two clamping portions;

[0007] During valve dilation, the intersection position of the upper clamping portions of the two clamping arms changes to reduce the clamping space between the clamping portions, so as to clamp the original leaflet within the clamping space.

[0008] This artificial valve anchoring device features two interconnected clamping arms with their upper clamping portions intersecting to create a clamping space between them. After the artificial valve anchoring device releases at a designated position, the valve expands and compresses, changing the intersection of the upper clamping portions of the two arms to reduce the clamping space between them. This clamps the native leaflet within the clamping space. Even with a smaller valve, it still provides excellent anchoring, preventing valve displacement. Furthermore, the artificial valve anchoring device's clamping of the regurgitation orifice of adjacent leaflets effectively reduces the risk of paravalvular leakage.

[0009] Optionally, the upper clamping portion of any of the clamping arms has a protrusion;

[0010] During valve dilation, the protrusions on the two clamping portions within the clamping space move closer to each other to clamp the original leaflet.

[0011] Optionally, the clamping part includes an upper clamping section and a lower clamping section connected to each other, and the upper clamping sections of the two clamping arms are intersecting to form the clamping space between the lower clamping sections of the two clamping arms; the protrusion is provided on the lower clamping section.

[0012] Optionally, the protrusion is an arc-shaped structure disposed on the lower clamping section, and the arc-shaped structure protrudes into the clamping space;

[0013] During valve dilation, the arc-shaped structures on the lower clamping segment approach each other to clamp the original leaflet.

[0014] Optionally, any of the clamping arms further includes an opening and closing portion connected to the clamping part, the opening and closing portion being connected to the upper clamping section;

[0015] During valve dilation, the two opening and closing portions are configured to be compressed by balloon dilation to drive the upper clamping segment to move, and to change the intersection position of the two upper clamping segments to reduce the clamping space between the clamping portions.

[0016] Optionally, the artificial valve anchoring device further includes a carrier arm connected between the opening and closing portions of the two clamping arms, and the carrier arm and the two opening and closing portions form an annular space suitable for inserting the balloon.

[0017] Optionally, the mounting arm is in the shape of an arc or a straight line.

[0018] Optionally, the clamping arm further includes a transition portion connected between the clamping portion and the mounting arm.

[0019] Optionally, the opening and closing portion, clamping portion, and transition portion on the clamping arm are connected in a smooth transition.

[0020] Optionally, the clamping arm and the mounting arm are coated with biological tissue or polymer material.

[0021] The artificial valve anchoring device provided by this utility model has the following advantages:

[0022] 1. This utility model provides an artificial valve anchoring device, including at least two interconnected clamping arms, each clamping arm including a clamping part, and the clamping parts on the two clamping arms are intersecting to form a clamping space between the two clamping parts; during the expansion of the anchoring device, the intersecting position of the clamping parts on the two clamping arms changes to reduce the clamping space between the clamping parts, so as to clamp the original leaflet in the clamping space.

[0023] This artificial valve anchoring device features two interconnected clamping arms with their upper clamping portions intersecting to create a clamping space between them. After the artificial valve anchoring device releases at a designated position, the valve expands and compresses, changing the intersection of the upper clamping portions of the two arms to reduce the clamping space between them. This clamps the native leaflet within the clamping space. Even with a smaller valve, it still provides excellent anchoring, preventing valve displacement. Furthermore, the artificial valve anchoring device's clamping of the regurgitation orifice of adjacent leaflets effectively reduces the risk of paravalvular leakage.

[0024] 2. This utility model provides an artificial valve anchoring device, wherein the upper clamping part of any of the clamping arms has a protrusion; during valve expansion, the protrusions on the two clamping parts located in the clamping space approach each other to clamp the original leaflet.

[0025] 3. This utility model provides an artificial valve anchoring device, wherein the surfaces of the clamping arm and the mounting arm can be covered with biological tissue or polymer material to avoid damage to the original valve leaflets and other tissues and the scaffold by the metal positioning component, and to provide a cell climbing channel to accelerate endothelialization. Attached Figure Description

[0026] To more clearly illustrate the specific embodiments of this utility model or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this utility model. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0027] Figure 1 This is a schematic structural view of the artificial valve anchoring device provided in an embodiment of the present invention.

[0028] Explanation of reference numerals in the attached figures:

[0029] 1-Upper clamping section;

[0030] 2-Lower clamping section;

[0031] 3-Opening and closing parts;

[0032] 4-Mounting arm;

[0033] 5-Transition section;

[0034] 6-Protrusion. Detailed Implementation

[0035] The technical solution of this utility model will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this utility model. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this utility model.

[0036] In the description of this utility model, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings and are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance. In addition, the technical features involved in the different embodiments of this utility model described below can be combined with each other as long as they do not conflict with each other.

[0037] Example

[0038] Heart valves are the fundamental structure of the heart, and severe valvular disease can lead to death. Heart valves can develop conditions such as insufficiency (regurgitation) and stenosis due to congenital or acquired inflammation. Transcatheter aortic valve replacement (TAVR), as a safe and effective minimally invasive interventional treatment, has become a first-line treatment for elderly patients with aortic stenosis (AS). TAVR was initially used to treat AS and has since been extended to treat aortic regurgitation (AR). However, AR patients have different anatomical structures, valve selection, surgical procedures, and complications compared to AS patients.

[0039] Some AR patients have large valve annulus, dilated left ventricular outflow tract (LVOT), non-calcified stenotic supravalvular anchoring area, and lack of anchoring anatomy at the junction of LVOT and sinus duct. The valve cannot withstand the strong diastolic blood flow pressure, making TAVR valve anchoring difficult and prone to displacement.

[0040] Therefore, this embodiment provides an artificial valve anchoring device, including two interconnected clamping arms and a mounting arm 4 connected between the two clamping arms. Each clamping arm includes an interconnected clamping part, an opening and closing part 3, and a transition part 5.

[0041] In this embodiment, the clamping portions on the two clamping arms are arranged to intersect to form a clamping space between the two clamping portions. During valve expansion, the squeezing opening and closing portion 3 changes the intersecting position of the clamping portions on the two clamping arms to reduce the clamping space between the clamping portions, so as to clamp the original leaflet in the clamping space.

[0042] The aforementioned artificial valve anchoring device is fixed to the artificial valve during use, and both are delivered into the human body through the existing delivery system. During expansion, the balloon in the delivery system expands to force the artificial valve to squeeze the opening and closing part 3 of the anchoring device, thereby changing the intersection position of the clamping parts on the two clamping arms to reduce the clamping space between the clamping parts and clamp the original leaflet within the clamping space.

[0043] As a specific implementation method, such as Figure 1 As shown, the clamping part includes an upper clamping section 1 and a lower clamping section 2 connected to each other. The clamping sections 1 on the two clamping arms intersect to form a clamping space between the lower clamping sections 2 of the two clamping arms. Figure 1 In the embodiment shown, when the artificial valve expands and squeezes the opening and closing part 3 of the anchoring device, the opening and closing parts 3 move away from each other, and the upper clamping sections 1 on the two clamping arms move closer to each other. During this process, the intersection position of the upper clamping sections 1 on the two clamping arms gradually moves downward, thereby reducing the clamping space between the lower clamping sections 2 of the two clamping arms. That is, the lower clamping sections 2 of the two clamping arms move closer to each other to clamp and fix the original leaflet inside.

[0044] To further improve the fixation effect on the original leaflets, in this embodiment, each clamping arm has a protrusion 6 on its clamping part; during the process of the opening and closing part 3 of the anchoring device being squeezed away from each other, the protrusions 6 on the two clamping parts in the clamping space approach each other to clamp the original leaflets.

[0045] Specifically, such as Figure 1As shown, the protrusion 6 is an arc-shaped structure provided on the lower clamping section 2, and the arc-shaped structure protrudes into the clamping space; during valve expansion, the opening and closing parts 3 of the anchoring device are squeezed away from each other, and the arc-shaped structures move closer to each other to clamp the original leaflet.

[0046] Furthermore, such as Figure 1 As shown, in this embodiment, a portion of the lower clamping section 2 is set to be an arc shape protruding towards the clamping space. In addition to being able to clamp the original petal by bringing the arc-shaped parts close together, a placement space can also be formed above the protruding part of the arc-shaped part. When the arc-shaped parts are brought close together to clamp the original petal, a part of the original petal can be placed in the placement space above the protruding part, so as to ensure that the clamping part of the arc-shaped part extends as far into the original petal as possible, ensuring the stability of the clamping.

[0047] In order to enable the clamping area of ​​the artificial valve anchoring device to tighten and clamp the valve leaflet after release, in this embodiment, the opening and closing parts 3 on the two clamping arms are connected to the upper clamping section 1; during valve dilation, the two opening and closing parts 3 are configured to be squeezed by the balloon dilation to drive the upper clamping section 1 to move, and change the intersection position of the two upper clamping sections 1 to reduce the clamping space between the clamping parts.

[0048] In this embodiment, the mounting arm 4 is connected between the opening and closing portions 3 of the two clamping arms, and the mounting arm 4 and the two opening and closing portions 3 form an annular space suitable for inserting the balloon.

[0049] In this structure, the ring structure formed by the opening and closing parts 3 on the two clamping arms and the carrying arm 4 is used to insert the balloon in the delivery system. When the balloon expands, it can force the opening and closing parts 3 to move away from each other. During this process, the intersection position of the upper clamping sections 1 on the two clamping arms gradually moves downward, thereby reducing the clamping space between the lower clamping sections 2 of the two clamping arms. That is, the lower clamping sections 2 of the two clamping arms move closer to each other to clamp and fix the original leaflet inside.

[0050] In this embodiment, the opening and closing part 3, the clamping part and the transition part 5 on the clamping arm are connected smoothly, and the mounting arm 4 is in the shape of an arc or a straight line, which is used to place on the native fusion ridge or native leaflet.

[0051] In this embodiment, as Figure 1 As shown, the transition section 5 connects the clamping section and the mounting arm 4, and is in the shape of an arc, a straight line, or a wave.

[0052] In this embodiment, the artificial valve anchoring device is made of a metallic material, particularly preferably a nickel-titanium alloy. The surfaces of the clamping arm and the mounting arm 4 may be coated with biological tissue or polymer materials.

[0053] In other embodiments, the number of clamping arms can also be set to three or more, depending on the specific needs. The artificial valve anchoring device can be a symmetrical or asymmetrical structure. In the asymmetrical structure, the number of native fusion ridges is greater than the number of clamping spaces on the artificial valve anchoring device. Corresponding to the non-clamping position of the native fusion ridge, the arc-shaped or straight mounting arm 4 on the artificial valve anchoring device rests or is placed on the native fusion ridge.

[0054] The artificial valve anchoring device provided in this embodiment includes the following steps when in use:

[0055] Step 1: Puncture both femoral arteries of the patient. Place a vascular sheath through the main approach and insert a pigtail catheter through the auxiliary approach to locate the lesion and for angiography.

[0056] Step 2: Press the artificial valve onto the balloon near the handle end, and use the push sheath to push it into the delivery system's inlet sheath along the guidewire. After the artificial valve anchoring device is released, the lower clamping section 2 of the clamping part forms an open clamping space at a certain angle, which is conducive to capturing the fusion ridge or leaflet. The upper clamping sections 1 overlap together. Based on the angiography and ultrasound images, observe the anatomy of the sinus and the positional relationship of the artificial valve anchoring device. Rotate the artificial valve anchoring device to achieve sinus alignment. The push-pull system moves the valve up and down. Adjust the bend to achieve coaxiality and complete the positioning.

[0057] Step 4: During rapid pacing, the balloon inflates and releases the valve. After valve expansion, the valve diameter changes from the smaller size during compression to a larger diameter that accommodates the valve annulus size. As the valve size increases, the artificial valve anchoring device expands. A special structural design ensures that the angle of the lower clamping segment 2 decreases as the diameter of the artificial valve anchoring device increases. This increases the force with which the artificial valve anchoring device clamps and fuses the ridge or leaflet, achieving the clamping function. Working in conjunction with the valve, it clamps the original leaflet in the middle, sealing the entire perivalvular region while anchoring the valve and preventing perivalvular leakage.

[0058] Step 5: Withdraw the delivery system, confirm the immediate effect with ultrasound, close the approach, and complete the surgery.

[0059] Among them, the artificial valve anchoring device can be connected to the valve or it can be implanted separately at the lesion site without connection to the valve.

[0060] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the protection scope of this invention.

Claims

1. An artificial valve anchoring device, characterized in that, include: At least two interconnected clamping arms, each of the clamping arms including a clamping portion, and the clamping portions on the two clamping arms are intersecting to form a clamping space between the two clamping portions; After the anchoring device is released into place, during the valve expansion process, the intersection position of the upper clamping parts of the two clamping arms is changed to reduce the clamping space between the clamping parts, so as to clamp the original leaflet within the clamping space.

2. The artificial valve anchoring device according to claim 1, characterized in that, Each of the clamping arms has a protrusion (6) on its upper clamping portion; During valve dilation, the protrusions (6) on the two clamping parts located in the clamping space approach each other to clamp the original leaflet.

3. The artificial valve anchoring device according to claim 2, characterized in that, The clamping part includes an upper clamping section (1) and a lower clamping section (2) connected to each other. The upper clamping sections (1) of the two clamping arms are intersecting to form the clamping space between the lower clamping sections (2) of the two clamping arms. The protrusion (6) is provided on the lower clamping section (2).

4. The artificial valve anchoring device according to claim 3, characterized in that, The protrusion (6) is an arc-shaped structure provided on the lower clamping section (2), and the arc-shaped structure protrudes into the clamping space; During valve dilation, the arc-shaped structures on the lower clamping segment (2) move closer to each other to clamp the original leaflet.

5. The artificial valve anchoring device according to claim 3 or 4, characterized in that, Each of the clamping arms further includes an opening and closing part (3) connected to the clamping part, the opening and closing part (3) being connected to the upper clamping section (1); During valve dilation, the two opening and closing portions (3) are configured to be squeezed by balloon dilation to drive the upper clamping segment (1) to move, and change the intersection position of the two upper clamping segments (1) to reduce the clamping space between the clamping portions.

6. The artificial valve anchoring device according to claim 5, characterized in that, It also includes a mounting arm (4), which is connected between the opening and closing portions (3) of the two clamping arms, and the mounting arm (4) and the two opening and closing portions (3) form an annular space suitable for inserting the balloon.

7. The artificial valve anchoring device according to claim 6, characterized in that, The mounting arm (4) is in the shape of an arc or a straight line.

8. The artificial valve anchoring device according to claim 6, characterized in that, The clamping arm also includes a transition portion (5), which is connected between the clamping portion and the mounting arm (4); The connection between the opening / closing part (3), the clamping part, and the transition part (5) on the clamping arm is a smooth transition.

9. The artificial valve anchoring device according to claim 6, characterized in that, The clamping arm and the mounting arm (4) are covered with biological tissue or polymer material.

10. The artificial valve anchoring device according to claim 1, characterized in that, The artificial valve anchoring device has a symmetrical or asymmetrical structure.

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