CN113288519A

Movatterモバイル変換

Info

Publication number: CN113288519A
Application number: CN202110745830.7A
Authority: CN
Inventors: 陈松; 王雪丽; 张长东; 孙明; 吴春林; 毛亮; 吴世超
Original assignee: Wuhan Weike Medical Technology Co ltd
Current assignee: Wuhan Weike Medical Technology Co ltd
Priority date: 2021-07-01
Filing date: 2021-07-01
Publication date: 2021-08-24

Abstract

Translated fromChinese

本发明公开了一种主动捕获瓣叶的经导管主动脉瓣装置，包括：支架、瓣叶、瓣裙和定位件，支架内壁固定连接有瓣裙，瓣裙上端固定连接有瓣叶，支架上端外壁连接有定位件。定位件为支架的伸出结构，并向下弯折形成的U型结构。U型结构的弯折结构为：圆弧状从支架上端伸出，伸出端垂直向下弯曲。解决了现有技术中，主动脉瓣装置定位不准，容易发生对主动脉血管及瓣膜周围组织损伤，甚至发生飞瓣、左室流出道伸出过多、遮挡冠脉等问题。该主动捕获瓣叶的经导管主动脉瓣装置，定位件可以与人体主动脉瓣窦主动适配，定位精准，保证定位件进入瓣窦；避免对主动脉发生损伤的问题；又可以保证支架的支撑力和稳定性，保证瓣叶的耐久性。

The invention discloses a transcatheter aortic valve device for actively capturing valve leaflets, comprising: a stent, a valve leaflet, a valve skirt and a positioning member; The outer wall is connected with a positioning piece. The positioning piece is a protruding structure of the bracket and is bent downward to form a U-shaped structure. The bending structure of the U-shaped structure is as follows: a circular arc protrudes from the upper end of the bracket, and the protruding end is bent vertically downward. In the prior art, the inaccurate positioning of the aortic valve device can easily cause damage to the aortic blood vessels and tissues around the valve, and even the problems of flying valve, excessive left ventricular outflow tract, and occlusion of the coronary artery. In the transcatheter aortic valve device that actively captures valve leaflets, the positioning member can be actively adapted to the human aortic valve sinus, and the positioning is accurate, ensuring that the positioning member enters the valve sinus, avoiding the problem of damage to the aorta, and ensuring the stability of the stent. Support force and stability to ensure the durability of the leaflet.

Description

Transcatheter aortic valve device capable of actively capturing valve leaflets

Technical Field

The invention relates to the technical field of structural design of instruments used in the field of interventional therapy of heart valve diseases, in particular to a transcatheter aortic valve device for actively capturing valve leaflets.

Background

With the aging population, the incidence of valvular heart disease is obviously increased, and the traditional surgical treatment is still the first choice treatment means for most patients with severe valvular diseases at present, but the risks of large trauma, high postoperative mortality, high complications and the like exist. In recent years, transcatheter valve implantation/repair is mature and widely applied, especially transcatheter aortic valve implantation (TAVR/TAVI) is based on evidence sufficiently, trauma is greatly reduced, and the recommendation of european and american guidelines for treatment of heart valve diseases is obtained, which is a milestone development in the field of interventional therapy of heart valve diseases.

Transcatheter Aortic Valve Implantation (TAVI), a new interventional technique for the placement of prosthetic aortic valves, was first reported in 2002 by Criber physicians in france, and has promised the treatment of patients with severe Aortic Stenosis (AS) who lost surgical opportunities (e.g., >80 years), AS well AS opened a new page of history of cardiovascular interventions.

Over the next 10 years, with the improvement of instruments and the accumulation of experience, the TAVI technique has been perfected and deployed in more than 500 heart centers in nearly 40 countries, with a total number of surgery of over 15 ten thousand. Particularly, after a series of registration studies and random control studies have successively confirmed their effectiveness, feasibility and safety, the TAVI technique has become the treatment of choice for patients with severe AS who cannot undergo surgical valve replacement.

The TAVI technology has made remarkable progress internationally, has been applied primarily in China, has the same wide prospect, is a market which is highly monopolized by foreign brands in China at present, and has emerged a batch of domestic appliance enterprises in China. According to echocardiographic statistical analysis of hospital patients, the detection rates of moderate or severe aortic insufficiency (AR) were 2.12% and 2.85%, respectively, the detection rates of moderate or severe Aortic Stenosis (AS) were 0.75% and 0.89%, respectively, and the detection rates of both groups of severe aortic insufficiency (SAR) and Severe Aortic Stenosis (SAS) were 0.52% VS 0.95% and 0.54% VS 0.57%, respectively, in patients aged 65-74 (49995 cases) and older than 75 (34671 cases). It is seen that the elderly in china are more prone to aortic insufficiency in aortic valve degeneration.

Disclosure of Invention

In view of the above, the main object of the present invention is to provide a medical device which has reasonable structural design, can be actively adapted and connected with the sinus of the valve of the human body, and has accurate positioning; but also can ensure the supporting force and the stability of the bracket and the durability of the valve leaflet.

In order to achieve the purpose, the technical scheme of the invention is realized as follows:

a transcatheter aortic valve device for actively capturing leaflets, comprising: the support comprises a support, valve leaflets, a valve skirt and a positioning piece, the inner wall of the support is fixedly connected with the valve skirt, the inner sides of the valve skirt are fixedly connected with the valve leaflets, and the outer wall of the upper end of the support is connected with the positioning piece.

In a preferred embodiment, the stent and the positioning member are self-expanding.

In a preferred embodiment, the positioning member is a protruding structure of the bracket and is bent downward to form a U-shaped structure.

In a preferred embodiment, the bending structure of the U-shaped structure is: the arc shape extends out from the upper end of the bracket, and the extending end is bent downwards.

In a preferred embodiment, the positioning member and the bracket are fixed by sewing.

In a preferred embodiment, the positioning element is welded to the bracket.

In a preferred embodiment, the positioning element is riveted to the bracket.

In a preferred embodiment, the positioning member and the bracket are integrally cut.

In a preferred embodiment, the height of the spacer is 5-20 mm.

In a preferred embodiment, the distance between the extending end of the positioning piece extending out of the bracket and the outer wall of the bracket is 5-20 mm.

In a preferred embodiment, the scaffold is a mesh structure, and the number of meshes of the mesh structure is 3 times of the circumference.

In a preferred embodiment, the number of meshes of the mesh structure is 9-18 per week; the three positioning pieces are uniformly arranged at the upper end of the net-shaped structure;

in a preferred embodiment, the bottom of the bracket is of a horn-shaped structure; the end part of the bottom of the bracket is of a vertical closing-up structure; the middle part and the upper end part of the bracket are in straight tubular structures.

In a preferred embodiment, the diameter of the straight cylindrical structure is: 20-36mm, the diameter of the closed end of the horn-shaped structure is as follows: 23-40mm, the distance between the extending end of the positioning piece extending out of the bracket and the outer wall of the bracket is 5-20mm, and the height of the bracket is 12-40 mm.

In a preferred embodiment, the leaflet is bovine pericardial leaflet.

In a preferred embodiment, the bovine pericardial leaflet is manufactured by one-time cutting of an integrated valve cutting mold.

In a preferred embodiment, the valve skirt is a PET film; the inner wall of the PET film attaching support is sewn and fixed.

In a preferred embodiment, the inner side of the PET film is fixed with bovine pericardial leaflet tissue by suturing.

In a preferred embodiment, the bottom end of the stent is fixed by skirt wrapping of a PET film.

In a preferred embodiment, the skirt wrapping height of the PET film is 5-30 mm.

In a preferred embodiment, the suture between the PET film and the stent and between the PET film and the bovine pericardial leaflet tissue is a medical suture.

The transcatheter aortic valve device for actively capturing the valve leaflet has the following beneficial effects:

the transcatheter aortic valve device for actively capturing leaflets comprises: the support comprises a support, valve leaflets and a positioning piece, wherein the valve leaflets are fixedly connected to the inner wall of the upper end of the support, and the positioning piece is integrally formed on the outer wall of the upper end of the support.

Solves the problems that the transcatheter aortic valve device for actively capturing the valve leaflet is inaccurate in positioning, the aortic blood vessel and the tissues around the valve are easy to be damaged, even the valve is flown, the left ventricular outflow tract is too much extended, the coronary artery is shielded, and the like in the prior art. Regurgitation patients caused by aortic insufficiency, and problems with aortic stenosis. According to the transcatheter aortic valve device for actively capturing the valve leaflets, the positioning piece can be actively matched with the aortic valve sinus of a human body, the positioning is accurate, and the positioning piece is ensured to enter the valve sinus; the problem of damage to the aorta is avoided; but also can ensure the supporting force and stability of the bracket and the durability of the valve leaf.

Drawings

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

Fig. 1 is a schematic structural view of a transcatheter aortic valve device actively capturing leaflets according to one embodiment of the present disclosure;

FIG. 2 is a schematic view of an integrally cut-away configuration of a transcatheter aortic valve device for actively capturing leaflets according to another embodiment of the present disclosure;

FIG. 3 is a top view of a unitary cut-out of a transcatheter aortic valve device actively capturing leaflets according to another embodiment of the present disclosure;

fig. 4 is a side view of a unitary cut-out version of a transcatheter aortic valve device actively capturing leaflets according to another embodiment of the present disclosure;

FIG. 5 is a bottom view of a unitary cutaway of a transcatheter aortic valve device actively capturing leaflets according to another embodiment of the present disclosure;

fig. 6 is a leaflet deployment view of a transcatheter aortic valve device actively capturing a leaflet according to one embodiment of the present disclosure;

FIG. 7 is a schematic view of a welded connection between a stent and a transcatheter aortic valve device positioning member for actively capturing leaflets according to yet another embodiment of the present disclosure;

FIG. 8 is a schematic view of a suture connection between a positioning member of a transcatheter aortic valve device for actively capturing leaflets and a stent according to yet another embodiment of the present disclosure;

figure 9 is a schematic view of a riveted connection between a transcatheter aortic valve device positioning member and a stent for actively capturing leaflets according to yet another embodiment of the present disclosure.

[ description of main reference symbols ]

1. A support;

2. a leaflet;

3. a positioning member;

4. a petticoat.

Detailed Description

The transcatheter aortic valve device for actively capturing leaflets of the present invention will be described in further detail with reference to the accompanying drawings and embodiments of the present invention.

It should be noted that the embodiments and features of the embodiments in the present application may be combined with each other without conflict. The present invention will be described in detail below with reference to the embodiments with reference to the attached drawings.

It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of example embodiments according to the present application. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, and it should be understood that when the terms "comprises" and/or "comprising" are used in this specification, they specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof, unless the context clearly indicates otherwise.

It should be noted that the terms "first," "second," and the like in the description and claims of this application and in the drawings described above are used for distinguishing between similar elements and not necessarily for describing a particular sequential or chronological order. It is to be understood that the data so used is interchangeable under appropriate circumstances such that the embodiments of the application described herein are, for example, capable of operation in sequences other than those illustrated or otherwise described herein. Furthermore, the terms "comprises," "comprising," and "having," and any variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, system, article, or apparatus that comprises a list of steps or elements is not necessarily limited to those steps or elements expressly listed, but may include other steps or elements not expressly listed or inherent to such process, method, article, or apparatus.

Spatially relative terms, such as "above … …," "above … …," "above … …," "above," and the like, may be used herein for ease of description to describe one device or feature's spatial relationship to another device or feature as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is turned over, devices described as "above" or "on" other devices or configurations would then be oriented "below" or "under" the other devices or configurations. Thus, the exemplary term "above … …" can include both an orientation of "above … …" and "below … …". The device may be otherwise variously oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

As shown in fig. 1, 2, 3, 4, 5, 7, 8, and 9, the transcatheter aortic valve device for actively capturing leaflets comprises: the self-expansion function supports thestent 1 of the aorta, thevalve leaf 2, thevalve skirt 4 and thepositioning piece 3 for positioning and fixing. The inner wall of thebracket 1 is fixedly connected with avalve skirt 4, the inner wall of the upper end of thevalve skirt 4 is fixedly connected with avalve leaf 2, and the outer wall of the upper end of thebracket 1 is connected with apositioning piece 3.

Because the aortic valve leaflet of the human body is in a half bowl shape, the aortic valve leaflet and the wall of the aortic sinus form a bowl pocket together, and the tip of the bowl pocket faces downwards and the mouth of the bowl pocket faces upwards. Thepositioning piece 3 enters the bowl pocket of the aortic valve leaflet of the human body from the upper part, can slide downwards to the bottom along the structure that the upper part of the valve sinus is big and the lower part is small, and can be guided to accurately enter the bowl pocket of the valve leaflet through the perspective and ultrasonic image modes, namely the valve leaflet is captured. In the implantation process, the self-body valve leaflet can be actively captured, accurate positioning is provided for the operation process of a doctor, the problem of fixing the aortic valve stent in a reflux medical record can be solved, and the aortic valve stent can be prevented from moving towards the ventricle.

This support adopts the nickel titanium alloy material, is formed by metal tubular product heat setting after laser cutting, promptly: the positioning piece and the bracket are integrally cut.

For more convenient adaptive connection with the human valve sinus, the structure is simpler, and the problem of short service life of the connection between thepositioning piece 3 and thebracket 1 in the long-term use process is avoided. Thepositioning piece 3 is an extended structure of thebracket 1 and is bent downwards to form a U-shaped structure; thebracket 1 and thepositioning piece 3 are self-expanding.

The bending structure of the U-shaped structure is as follows: the arc shape extends out from the upper end of thebracket 1, and the extending end is bent downwards.

In another embodiment, as shown in fig. 7, the positioning member and the bracket are fixed by sewing, welding or riveting.

The side structure of support is circular-arc tail end vertical downwarping, can reduce to turn over the scraping effect of in-process to the vascular wall at settingelement 3, plays fine guard action to the vascular wall.

Preferably, any length sufficient to capture a body leaflet when the stent is in a compressed state is inserted into the sinus structure. The height of thepositioning piece 3 is 5-20 mm; preferably, the height of thespacer 3 is 5-10 mm. The distance between the extending end of thepositioning piece 3 extending out of thebracket 1 and the outer wall of thebracket 1 is 5-20 mm; preferably, the distance between the extending end of thepositioning piece 3 extending out of thebracket 1 and the outer wall of thebracket 1 is 8-12 mm.

After thepositioning piece 3 is positioned, thebracket 1 can be ensured to have the extension length of 5-10mm at the left chamber outflow channel side, and the left chamber outflow channel can be effectively riveted without causing valve flying. Meanwhile, the left ventricle outflow tract can not be extended too much, so that the conduction system and the mitral valve opening are not affected.

In order to further position thepositioning element 3, in particular to ensure uniform positioning and to achieve a positional adaptation to the aortic valve of the human body, thestent 1 is of a mesh structure, and the number of meshes of the mesh structure is 3 times that of the circumference. Ensure that thepositioning piece 3 which is integrally formed can just extend out of the connecting part of the reticular structure.

Preferably, the number of the meshes of the net-shaped structure is 9-18 per circle, and the number of the meshes of the net-shaped structure is 12 or 15 per circle; threepositioning pieces 3 are uniformly arranged at the upper end of the reticular structure.

In order to ensure that thebracket 1 is well fixed at the position of the aortic valve of a human body, the bracket is prevented from moving away from a ventricle in the blood flowing process, and the aorta is protected from being damaged. The bottom of thebracket 1 is of a horn-shaped structure; the end part of the bottom of thebracket 1 is in a vertical closing-up structure (the bracket can prevent the bracket from damaging the wall of the aortic vessel of the left ventricular outflow tract); the middle part and the upper end part of thebracket 1 are in straight tubular structures.

The diameter of the straight cylindrical structure is as follows: 20-36mm, the diameter of the closed end of the horn-shaped structure is as follows: 23-40mm, the distance between the extending end of thepositioning piece 3 extending out of thebracket 1 and the outer wall of thebracket 1 is 5-20mm, and the height of thebracket 1 is 12-40 mm.

Preferably, the diameter of the straight cylindrical structure is: 26mm, the diameter of the closed end of the horn-shaped structure is as follows: 30mm, the distance from the extending end of thepositioning piece 3 extending out of thesupport 1 to the outer wall of thesupport 1 is 9mm or 12mm, and the height of thesupport 1 is 25mm.

The length dimension of thestent 1 ensures support for aortic stenosis problems.

In order to improve the durability of the whole device, especially the problem of poor durability when a common porcine pericardium is used, thedevice leaflet 2 is a bovine pericardial leaflet.

Thevalve leaflet 2 of the device can also adopt a porcine pericardium or a porcine heart valve.

In order to ensure the forming effect, the bovine pericardial valve leaflet is manufactured by one-time cutting of an integrated valve cutting mold;

as shown in figure 6, the bovine pericardial valve leaflet has reasonable structural design by providing an integrated valve cutting mold, and the valve sizes and the sewing sites corresponding to different aortic valve diameters are fixed in the mold, so that the cutting process can be standardized, the cutting time is greatly reduced, and the forming effect is ensured.

Thevalve skirt 4 of the device is a PET film; the inner wall of the PETfilm attaching support 1 is sewn and fixed.

The PET film can effectively prevent the problems of valve periphery leakage and the like by selecting a textile polyester fabric with low water permeability, high tensile strength and high puncture strength, and simultaneously improves the sewing and fixing strength between the valve and the bracket. Preferably, the technical parameters of the textile polyester fabric are as follows: the water penetration is less than or equal to 300 Ml/(cm)²Min), the warp-wise tensile strength is more than or equal to 6N/mm, the weft-wise tensile strength is more than or equal to 5.5N/mm, the probe breaking strength is more than or equal to 250N, and the suture pulling strength is more than or equal to 1N.

Preferably, in order to further improve the suture fixing strength, the inner side of the PET film is fixed with the tissue of the bovine pericardial valve leaflet by suture.

In order to protect the wall of the aorta vessel of a human body, the bottom end part of thestent 1 is wrapped and fixed by a skirt edge of a PET film; the support bottom binding off and wrap up with the PET shirt rim, can avoid the support edge comparatively sharp and sharp-pointed, and the support is because its diameter is greater than human left ventricle outflow tract diameter, pierces the problem of pipe wall easily after the self-expansion to probably damage the problem of pipe wall under the effect of internal repeated blood flow impact force.

Preferably, the wrapping height of the skirt edge of the PET film is 5-30 mm.

The suture lines between the PET film and thebracket 1 and between the PET film and the bovine pericardial valve leaflet tissue are medical suture lines.

The problem of aortic valve regurgitation through percutaneous treatment is solved, and the problems that the aortic valve is not positioned well, does not easily enter the sinus and is easily damaged in the prior art are solved; the main body of thebracket 1 has weak supporting force and can not cover narrowness; thebracket 1 is too short and easy to shift; perivalvular leakage is easy to occur.

The above description is only a preferred embodiment of the present invention, and is not intended to limit the scope of the present invention.

Claims

1. A transcatheter aortic valve device for actively capturing leaflets, comprising: support (1), valve leaf (2), valve skirt (4) and setting element (3), support (1) inner wall fixedly connected with valve skirt (4), valve skirt (4) inboard fixedly connected with valve leaf (2), support (1) upper end outer wall connection has setting element (3).

2. The transcatheter aortic valve device for active capture of leaflets of claim 1, wherein the stent (1) and positioning member (3) are self-expanding;

the positioning piece (3) is of an extending structure of the bracket (1) and is bent downwards to form a U-shaped structure;

the bending structure of the U-shaped structure is as follows: the arc shape extends out from the upper end of the bracket (1), and the extending end is bent downwards;

the positioning piece (3) and the bracket (1) are sewn and fixed or welded or riveted or integrally cut.

3. The transcatheter aortic valve device for active capture of leaflets according to claim 2, wherein the positioning member (3) has a height of 5-20 mm;

the distance between the extending end of the positioning piece (3) extending out of the bracket (1) and the outer wall of the bracket (1) is 5-20 mm.

4. The transcatheter aortic valve device for active capture of leaflets of claim 3, wherein the stent (1) is a mesh structure with meshes 3 times as many as one week.

5. The transcatheter aortic valve device for actively capturing leaflets of claim 4, wherein the mesh of the mesh structure has 9-18 meshes per week; the three positioning pieces (3) are uniformly arranged at the upper end of the net-shaped structure;

the bottom of the bracket (1) is of a horn-shaped structure; the end part of the bottom of the bracket (1) is of a vertical closing-up structure; the middle part and the upper end part of the bracket (1) are in straight tubular structures.

6. The transcatheter aortic valve device for active capture of leaflets of claim 5, wherein the straight cylinder structure has a diameter of: 20-36mm, the diameter of the closed end of the horn-shaped structure is as follows: 23-40mm, the distance between the extending end of the positioning piece (3) extending out of the bracket (1) and the outer wall of the bracket (1) is 5-20mm, and the height of the bracket (1) is 12-40 mm.

7. The transcatheter aortic valve device for active capture of leaflets according to claim 1, wherein the leaflet (2) is bovine pericardial leaflet;

the bovine pericardial valve leaflet is manufactured by one-time cutting of an integrated valve cutting mold.

8. The transcatheter aortic valve device for active capture of leaflets of claim 7, wherein the valve skirt (4) is a PET film; the inner wall of the PET film attaching support (1) is sewn and fixed.

9. The transcatheter aortic valve device for actively capturing leaflets of claim 8, wherein the inside of the PET film is sutured to bovine pericardial leaflet tissue.

10. The transcatheter aortic valve device for active capture of leaflets of claim 9, wherein the stent (1) bottom end is secured using PET membrane skirt wrap;

the wrapping height of the skirt edge of the PET film is 5-30 mm;

the suture lines between the PET film and the bracket (1) and between the PET film and the bovine pericardial valve leaflet tissue are medical suture lines.