Valve clip for treating bicuspid aortic valve disease

Abstract

The present application relates to the technical field of medical devices, and discloses a valve clamp (1) for treating two-leaflet aortic valve diseases, which comprises a first clamping part (11), a second clamping part (12) and a third clamping part, the third clamping part having a first sub-clamping part (13) and a second sub-clamping part (14), wherein the first clamping part (11) and the first sub-clamping part (13) are arranged to clamp a first leaflet of two-leaflet human valve leaflets outside a valve stent in cooperation when the valve stent is in a working state, and the second clamping part (12) and the second sub-clamping part (14) are arranged to clamp a second leaflet of two-leaflet human valve leaflets outside the valve stent in cooperation when the valve stent is in the working state. The valve clamp can be used for the insufficiency of two-leaflet valve deformity, is suitable for patients with two-leaflet valve deformity (especially Type 0), and is convenient to connect with an existing artificial heart valve stent.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a valve clip of a heart valve stent suitable for treating bicuspid aortic valve disease. Background Art

[0002] The normal aortic valve consists of three semilunar valves, the bases of which are supported by the aortic root. The aortic wall bulges outward to form the aortic sinus, which is classified as left, right, or non-coronary depending on the opening of the coronary artery. A bicuspid aortic valve occurs when the aortic valve leaflets partially fuse, resulting in a structure where only two leaflets open and close. Depending on the location of the fusion, bicuspid valves can be classified as Type 0, Type 1, or Type 2.

[0003] like Figure 7 As shown, Type 0 is divided into vertical and horizontal types according to the closed line. The vertical type consists of left and right lobes, with the left and right coronary arteries on both sides. The horizontal type consists of anterior and posterior lobes, with the left and right coronary arteries both located in the front. The domestic incidence rate is approximately 30%-50%; Type 1 is divided into left and right coronary valve fusion type (L+R type), right non-coronary valve fusion type (R+N type), and left non-coronary valve fusion type (L+N type) according to the position of the fusion ridge; Type 2 has two valve leaflets fused.

[0004] Bicuspid aortic valve disease is primarily categorized as aortic stenosis and aortic regurgitation. When stenosis is caused by leaflet calcification, all types of bicuspid valve deformities are treated with conventional TAVI surgery, with the implantation of a prosthetic heart valve. When pure leaflet regurgitation occurs, Type 1 and Type 2 valves still have three leaflet arches, so the existing three-arch clip is still suitable. However, for Type 0 valves, which have only two leaflet arches, the existing three-arch clip is not suitable. Summary of the Invention

[0005] In order to solve the above problems, an embodiment of the present invention provides a valve clip that can be applied to bicuspid aortic valve disease.

[0006] On the one hand, an embodiment of the present invention provides a valve clip (1) for treating bicuspid aortic valve disease, wherein the valve clip includes a first clamping portion (11), a second clamping portion (12) and a third clamping portion, wherein the third clamping portion has a first sub-clamping portion (13) and a second sub-clamping portion (14), wherein the first clamping portion (11) and the first sub-clamping portion (13) are configured to cooperate with each other to clamp the first leaflet of the bicuspid human valve leaflet outside the valve stent when the valve stent is in a working state, and the second clamping portion (12) and the second sub-clamping portion (14) are configured to cooperate with each other to clamp the second leaflet of the bicuspid human valve leaflet outside the valve stent when the valve stent is in a working state.

[0007] In some embodiments of the application, the valve clamp further comprises connecting portions (151, 152, 153) for connecting the valve clamp to the valve holder, the connecting portions being connected between the first clamping portion (11) and the second clamping portion (12), the second clamping portion (12) and the third clamping portion, and the third clamping portion and the first clamping portion (11), respectively.

[0008] In some embodiments of the application, the valve clamp further comprises an abutting portion (154) connected between the first sub-clamping portion (13) and the second sub-clamping portion (14), the abutting portion (154) being arranged to abut against the valve holder when the valve holder is in a compressed state.

[0009] In some embodiments of the application, the abutting portion (154) is provided with a retaining rod (155) arranged to retain the abutting portion (154) against the valve holder when the valve holder is in a compressed state and the first sub-clamping portion (13) and the second sub-clamping portion (14) are in an open state.

[0010] In some embodiments of the application, the first clamping portion (11), the second clamping portion (12), the first sub-clamping portion (13) and the second sub-clamping portion (14) are all V-shaped with an arc base and a pair of top ends, the arc base of at least one of the first clamping portion (11) and the first sub-clamping portion (13) being arranged to abut against the sinus portion of the first valve leaflet when the valve holder is in a working state, and the arc base of at least one of the second clamping portion (12) and the second sub-clamping portion (14) being arranged to abut against the sinus portion of the second valve leaflet when the valve holder is in a working state.

[0011] In some embodiments of the application, the connecting portions (151, 152, 153) and the abutting portion (154) are all connected between the V-shaped top ends of adjacent clamping portions.

[0012] In some embodiments of the application, the connecting portions (151, 152, 153) are arranged to be evenly distributed circumferentially along the valve holder when connected to the valve holder.

[0013] In some embodiments of the application, fabric is stitched between the arc base of the first clamping portion and the arc base of the first sub-clamping portion, and fabric is stitched between the arc base of the second clamping portion and the arc base of the second sub-clamping portion.

[0014] In some embodiments of the present invention, the arc bottom of at least one of the first clamping portion and the first sub-clamping portion is provided with a through hole, the arc bottom of at least one of the second clamping portion and the second sub-clamping portion is provided with a through hole, and the free end of the retaining rod is provided with a through hole, and the through hole is filled with developing material.

[0015] On the other hand, an embodiment of the present invention provides a valve graft for treating bicuspid aortic valve disease, comprising: a valve stent; an artificial valve leaflet connected to the inside of the valve stent; and the aforementioned valve clip, which is connected to the outside of the valve stent along the circumference of the valve stent.

[0016] Because the third clamping portion of the valve clip is divided into a first sub-clamping portion and a second sub-clamping portion, and the sub-clamping portions cooperate with the first and second clamping portions to clamp the valve leaflets, the valve clip has two sets (four) of curved bases, which can address regurgitation caused by bicuspid valve anomalies and is suitable for patients with bicuspid valve anomalies (especially Type 0). The valve clip also has three evenly distributed connection portions, which facilitates connection to existing artificial heart valve stents.

[0017] Various aspects, features, advantages, etc. of the embodiments of the present invention will be described in detail below in conjunction with the accompanying drawings. According to the following detailed description in conjunction with the accompanying drawings, the above aspects, features, advantages, etc. of the present invention will become more clear. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 3D is a schematic three-dimensional diagram of the valve clip according to Example 1 of the present invention.

[0019] Figure 2 It shows Figure 1 Schematic top view of the valve clip shown attached to the valve stent in a blood vessel.

[0020] Figure 3 It shows Figure 1 Schematic diagram of the valve clip shown connected to the valve stent during delivery.

[0021] Figure 4 3D is a schematic three-dimensional diagram of a valve clip according to Example 2 of the present invention.

[0022] Figure 5 It shows Figure 4 Schematic top view of the valve clip shown attached to the valve stent in a blood vessel.

[0023] Figure 6 3D is a schematic three-dimensional diagram of a valve clip according to Example 3 of the present invention.

[0024] Figure 7 It shows Figure 6A three-dimensional schematic diagram of the valve clip when connected to the valve stent is shown.

[0025] Figure 8 Schematic diagram of Type 0, Type 1, and Type 2 bicuspid valve deformity. DETAILED DESCRIPTION

[0026] To facilitate understanding of the various aspects, features, and advantages of the technical solution of the present invention, the present invention is described in detail below with reference to the accompanying drawings. It should be understood that the various embodiments described below are for illustration only and are not intended to limit the scope of protection of the present invention. Various combinations of the various embodiments of the present invention may be made without departing from the essence of the present invention.

[0027] An embodiment of the present invention provides a heart valve graft, which includes a valve stent 2, an artificial valve leaflet connected to the interior of the valve stent, and a valve clip 1 connected to the exterior of the valve stent along the circumference of the valve stent. The valve stent can be an existing stent suitable for a three-arc bottom valve clip (i.e., three clamping parts), and the valve stent is provided with three connecting parts along the circumference for connection of the valve clip. In order to make the valve graft suitable for patients with bicuspid valve deformity (especially Type 0), the present invention replaces one of the clamping parts of the existing three-arc bottom valve clip with two sub-clamping parts to separately clamp the two human valve leaflets.

[0028] [Example 1]

[0029] The following combination Figures 1 to 3 The valve clip according to Example 1 of the present invention will be described in detail. Figure 1 is a three-dimensional schematic diagram of a valve clip according to Example 1 of the present invention, Figure 2 It shows Figure 1 Schematic diagram of the top view of the valve clip in the blood vessel when connected to the valve stent. Figure 3 It shows Figure 1 Schematic diagram of the valve clip shown connected to the valve stent during delivery.

[0030] like Figures 1 to 3 As shown, the valve clamp 1 includes a first clamping part 11, a second clamping part 12 and a third clamping part, and the third clamping part is a first sub-clamping part 13 and a second sub-clamping part 14, wherein the first clamping part 11 and the first sub-clamping part 13 are configured to cooperate to clamp the first leaflet 31 of the bileaflet human valve leaflet outside the valve stent 2 when the valve stent 2 is in a working state, and the second clamping part 12 and the second sub-clamping part 14 are configured to cooperate to clamp the second leaflet 32 ​​of the bileaflet human valve leaflet outside the valve stent 2 when the valve stent 2 is in a working state.

[0031] In this embodiment, the first clamping portion 11, the second clamping portion 12, the first sub-clamping portion 13 and the second sub-clamping portion 14 are all V-shaped, the first clamping portion 11 has an arc bottom 111 located at the proximal end and a pair of tops 112, 113 extending from the arc bottom to the distal end, the second clamping portion 12 has an arc bottom 121 located at the proximal end and a pair of tops 122, 123 extending from the arc bottom to the distal end, the first sub-clamping portion 13 has an arc bottom 131 located at the proximal end and a pair of tops 132, 133 extending from the arc bottom to the distal end, and the second sub-clamping portion 14 has an arc bottom 141 located at the proximal end and a pair of tops 142, 143 extending from the arc bottom to the distal end.

[0032] The arc bottom 111 of the first clamping portion 11 is configured to abut against the sinus of the first leaflet 31 when the valve stent is in the working state, and the arc bottom 121 of the second clamping portion 12 is configured to abut against the sinus of the second leaflet 32 ​​when the valve stent is in the working state. In an optional embodiment, the arc bottom 111 of the first clamping portion 11 and the arc bottom 131 of the first sub-clamping portion 13, the arc bottom 121 of the second clamping portion 12, and the arc bottom 141 of the second sub-clamping portion 14 can all abut against the sinus of the corresponding leaflet, or only the arc bottom 131 of the first sub-clamping portion 13 and the arc bottom 141 of the second sub-clamping portion 14 can abut against the corresponding sinus.

[0033] In this embodiment, a connection portion 151 is connected between the first clamping portion 11 and the second clamping portion 12, a connection portion 152 is connected between the second clamping portion 12 and the second sub-clamping portion 14 of the third clamping portion, and a connection portion 153 is connected between the first sub-clamping portion 13 of the third clamping portion and the first clamping portion 11. These connection portions cooperate with the original connection portions on the valve stent to connect the valve clip to the outside of the valve stent. Specifically, the connection between the top 112 of the first clamping portion 11 and the top 123 of the second clamping portion 12 forms an arc top, which is the connection portion 151; the connection between the top 122 of the second clamping portion 12 and the top 143 of the second sub-clamping portion 14 forms an arc top, which is the connection portion 152; and the connection between the top 113 of the first clamping portion 11 and the top 132 of the first sub-clamping portion 13 forms an arc top, which is the connection portion 153. The connection parts 151, 152, and 153 are arranged to be evenly distributed along the circumference of the valve stent 2 when connected to the valve stent 2, and are 120° apart from each other, so as to cooperate with the three connection parts (not shown) arranged along the circumference of the existing valve stent.

[0034] Furthermore, an abutment portion 154 is connected between the first sub-clamping portion 13 and the second sub-clamping portion 14. This abutment portion 154 is configured to abut against the valve stent, particularly when the valve stent 2 is in a compressed state. Specifically, the top 133 of the first sub-clamping portion 13 and the top 142 of the second sub-clamping portion 14 are connected to form an arc top, which serves as the abutment portion 154.

[0035] In order to ensure that the abutment portion 154 can be stored when the valve graft is in a semi-compressed state (i.e., the clamping portion of the valve clip 1 is released and opened, but the valve stent 2 is not released and is in a compressed state), a retaining rod 155 is also provided on the abutment portion 154. The retaining rod 155 extends from the abutment portion 154 to the proximal end and is configured to keep the abutment portion 154 against the valve stent when the valve stent is in a compressed state and the clamping portions are in an open state, so that the clamping portions can grasp the human valve leaflets. In this way, during the transportation of the valve graft, the retaining rod 155 can be inserted into the sleeve for compressing the proximal end of the valve stent (such as Figure 3 As shown), the abutting portion 154 is retracted and close to the valve stent like the connecting portions 151, 152, and 153, and the clamping portions can be opened to grasp the human valve leaflets.

[0036] [Example 2]

[0037] The following combination Figures 4 and 5 The valve clip according to Example 2 of the present invention will be described in detail. Figure 4 is a three-dimensional schematic diagram of a valve clip according to Example 2 of the present invention, Figure 5 It shows Figure 4 Schematic top view of the valve clip shown attached to the valve stent in a blood vessel.

[0038] The main difference between the valve clip in this embodiment and the valve clip in Example 1 is that fabric is additionally sewn between the clamping parts.

[0039] like Figure 4 and Figure 5As shown, a fabric 16 is sewn between the arc bottom 111 of the first clamping part 11 and the arc bottom 131 of the first sub-clamping part 13, and a fabric 17 is sewn between the arc bottom 121 of the second clamping part 12 and the arc bottom 141 of the second sub-clamping part 14. By rotating the valve graft in vivo, the first leaflet 31 can be clamped between the first clamping part 11 and the first sub-clamping part 13 and the valve stent, and the second leaflet 32 ​​can be clamped between the second clamping part 12 and the second sub-clamping part 14 and the valve stent. The gaps between the first clamping part 11 and the second clamping part 12, and between the first sub-clamping part 13 and the second sub-clamping part 14, allow the body's valve leaflet connections to pass through. Since the leaflet connection may be clamped in the gap between the first clamping part 11 and the first sub-clamping part 13, and the gap between the second clamping part 12 and the second sub-clamping part 14 if the valve graft is rotated in the body improperly, the fabric is sewn between the arc bottom 111 of the first clamping part 11 and the arc bottom 131 of the first sub-clamping part 13, and between the arc bottom 121 of the second clamping part 12 and the arc bottom 141 of the second sub-clamping part 14, respectively, to ensure that the leaflet connection can only enter the gap between the first clamping part 11 and the second clamping part 12, and the gap between the first sub-clamping part 13 and the second sub-clamping part 14.

[0040] [Example 3]

[0041] The following combination Figure 6 and Figure 7 The valve clip according to Example 3 of the present invention will be described in detail. Figure 6 is a three-dimensional schematic diagram of a valve clip according to Example 3 of the present invention, Figure 7 It shows Figure 6 A three-dimensional schematic diagram of the valve clip when connected to the valve stent is shown.

[0042] The main difference between the valve clip in this embodiment and the valve clip in Example 1 is that the arc bottom of the clamping portion and the free end of the retaining rod are further provided with a developing point.

[0043] like Figure 6 and Figure 7 As shown, the arc bottoms of the first clamping portion 11 and the second clamping portion 12 are provided with through holes 114 and 124, which are filled with a developer material, so that the bottoms of the clamping portions have a developer point, which facilitates observation of the position of the arc bottom of the clamping portion within the human body during the release process, thereby determining whether the arc bottom has reached the sinus of the human valve leaflet. In an optional embodiment, the arc bottoms of the first sub-clamping portion 13 and the second sub-clamping portion 14 may also be provided with through holes filled with developer material, and at least two of the first clamping portion 11, the second clamping portion 12, the first sub-clamping portion 13, and the second sub-clamping portion 14 may be provided with through holes filled with developer material.

[0044] In this embodiment, the free end of the retaining rod 155 is also provided with a through hole 156 filled with developing material, which is convenient for observing the position of the retaining rod in the human body during the release process. In addition, the three developing points (the developing points at the bottom of the arc of the two clamping parts and the developing points of the retaining rod) also make it easier to identify the posture (tilt angle and position) of the valve stent in the body.

[0045] In the present invention, the developing material may be a high-density metal, such as gold, platinum, tantalum, palladium, iridium, tungsten, or a combination thereof, such as platinum-iridium alloy, platinum-tungsten alloy, and the like.

[0046] Those skilled in the art should understand that what is disclosed above is merely an embodiment of the present invention, and certainly cannot be used to limit the scope of rights of the present invention. Equivalent changes made based on the embodiment of the present invention are still within the scope covered by the claims of the present invention.

Claims

1. A valve clip for treating bicuspid aortic valve disease, characterized in that: The valve clip comprises a first clamping portion (11), a second clamping portion (12) and a third clamping portion, wherein the third clamping portion has a first sub-clamping portion (13) and a second sub-clamping portion (14), wherein the first clamping portion (11) and the first sub-clamping portion (13) are configured to cooperate with each other to clamp the first leaflet of the bileaflet human valve leaflet outside the valve stent when the valve stent is in a working state, and the second clamping portion (12) and the second sub-clamping portion (14) are configured to cooperate with each other to clamp the second leaflet of the bileaflet human valve leaflet outside the valve stent when the valve stent is in a working state; The first clamping portion (11), the second clamping portion (12), the first sub-clamping portion (13) and the second sub-clamping portion (14) are all V-shaped, the first clamping portion (11) having an arc bottom (111) located at the proximal end and a pair of top ends (112, 113) extending from the arc bottom to the distal end, the second clamping portion (12) having an arc bottom (121) located at the proximal end and a pair of top ends (122, 123) extending from the arc bottom to the distal end, the first sub-clamping portion (13) having an arc bottom (131) located at the proximal end and a pair of top ends (132, 133) extending from the arc bottom to the distal end, the second sub-clamping portion (14) having an arc bottom (141) located at the proximal end and a pair of top ends (142, 143) extending from the arc bottom to the distal end, Fabric is sewn between the arc bottom of the first clamping part and the arc bottom of the first sub-clamping part, and fabric is sewn between the arc bottom of the second clamping part and the arc bottom of the second sub-clamping part. A connecting portion (151) is connected between the first clamping portion (11) and the second clamping portion (12), a connecting portion (152) is connected between the second clamping portion (12) and the second sub-clamping portion (14), and a connecting portion (153) is connected between the first sub-clamping portion (13) and the first clamping portion (11). The valve clip further comprises abutting portion (154) connected between the first sub-clamping portion (13) and the second sub-clamping portion (14), wherein the abutting portion (154) is configured to abut against the valve stent when the valve stent is in a compressed state.

2. The valve clip according to claim 1, wherein: A retaining rod (155) is provided on the abutting portion (154), and the retaining rod is configured to keep the abutting portion (154) against the valve stent when the valve stent is in a compressed state and the first sub-clamping portion (13) and the second sub-clamping portion (14) are in an open state.

3. The valve clip according to claim 2, wherein: The arc bottom of at least one of the first clamping portion (11) and the first sub-clamping portion (13) is configured to abut against the sinus portion of the first leaflet when the valve stent is in a working state, and the arc bottom of at least one of the second clamping portion (12) and the second sub-clamping portion (14) is configured to abut against the sinus portion of the second leaflet when the valve stent is in a working state.

4. The valve clip according to claim 1, wherein: The connection parts (151, 152, 153) are configured to be evenly distributed along the circumference of the valve stent when connected to the valve stent.

5. The valve clip according to claim 3, wherein: The arc bottom of at least one of the first clamping part and the first sub-clamping part is provided with a through hole, the arc bottom of at least one of the second clamping part and the second sub-clamping part is provided with a through hole, the free end of the retaining rod is provided with a through hole, and the through hole is filled with developing material.

6. A valve graft for treating bicuspid aortic valve disease, characterized in that: include: Valve stents; an artificial valve leaflet connected to an interior of the valve stent; as well as The valve clip according to any one of claims 1 to 5, wherein the valve clip is connected to the outside of the valve stent along the circumference of the valve stent.

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