WO2023206710A1 - Valve stent and valve prosthesis - Google Patents

Valve stent and valve prosthesis Download PDF

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Publication number
WO2023206710A1
WO2023206710A1 PCT/CN2022/096676 CN2022096676W WO2023206710A1 WO 2023206710 A1 WO2023206710 A1 WO 2023206710A1 CN 2022096676 W CN2022096676 W CN 2022096676W WO 2023206710 A1 WO2023206710 A1 WO 2023206710A1
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WIPO (PCT)
Prior art keywords
barbs
valve
leaflet
posterior
area
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PCT/CN2022/096676
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French (fr)
Chinese (zh)
Inventor
张婧
刘世红
邱尧
陈国明
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上海微创心通医疗科技有限公司
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Publication of WO2023206710A1 publication Critical patent/WO2023206710A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body

Definitions

  • the present application relates to the technical field of medical devices, and in particular to a valve stent and a valve prosthesis.
  • Mitral valve, tricuspid valve, and aortic valve diseases are relatively common clinical heart valve diseases.
  • the human heart is divided into four chambers: left atrium, left ventricle, right atrium, and right ventricle.
  • the two atria are connected to the two ventricles respectively, and the two ventricles are connected to the two aorta.
  • the mitral valve grows between the left atrium and the left ventricle and is composed of leaflets, annulus, chordae tendineae, and papillary muscles. It functions as a one-way valve to ensure that blood flow is only allowed to move in one direction from the left atrium to the left ventricle. .
  • Mitral regurgitation one of the most common mitral valve diseases, occurs when the mitral valve fails to close properly during the ventricular systole phase and blood flows backward from the left ventricle into the left atrium.
  • the use of mitral valve replacement devices is one of the common treatments.
  • the mitral valve replacement device is an implantable prosthetic device, which consists of three parts: artificial valve leaflets, skirt, and stent. The function of the stent is to fix the artificial valve leaflets in the position of the native mitral valve leaflets, so that the artificial valve leaflets can work normally and fix the native mitral valve leaflets to ensure normal blood flow in the left heart.
  • valve stent of the valve prosthesis fix the native valve leaflets, such as using barbs to fix the valve stent and the native valve leaflets.
  • the barbs are usually designed to be evenly distributed and do not conform to the heart. Physiological structure of native tissue. At the same time, too many barbs will cause damage to the native valve leaflets and surrounding tissues, such as the aortic valve, myocardium, chordae tendineae, etc., which is detrimental to the treatment effect and may even cause complications.
  • the purpose of this application is to provide a valve stent and a valve prosthesis to solve the current problem in the valve stent that the barbs seriously damage the native valve leaflets and surrounding tissues.
  • a valve stent which includes a stent body and a barb structure; the stent body is divided along its own circumferential direction into at least an anterior leaflet region, a posterior leaflet region, and a valve leaflet connection region;
  • the barb structure includes at least two rows of barbs, each row of barbs is arranged along the circumference of the stent body, and the density of barbs provided in the leaflet connection area is smaller than the density of barbs in the front leaflet area. , and not greater than the density of barbs in the posterior leaf area.
  • the rear leaf area includes a rear leaf area, a middle area of the rear leaf and a front area of the rear leaf, and the density of barbs provided in the middle area of the rear leaf is smaller than the rear area and/or the rear leaf. or the density of barbs in the anterior region of the posterior lobe.
  • the leaflet connection area at least includes a front connection area and a rear connection area, and at least one of the front connection area, the rear connection area and the middle area of the rear leaflet. The operator does not set any barbs.
  • the leaflet connection area at least includes a front connection area and a rear connection area, and the front connection area and/or the rear connection area are along the circumferential direction of the stent body.
  • the angle distribution is greater than 0° and less than or equal to 90°, and the angle distribution of the front leaf region along the circumferential direction of the stent body is 60° to 180°.
  • the rear leaf area includes a rear leaf area, a middle area of the rear leaf, and a front area of the rear leaf, and the angle distribution of the middle area of the rear leaf along the circumferential direction of the stent body is 0° to 90°.
  • the angle distribution of the rear area of the rear leaf and/or the front area of the rear leaf along the circumferential direction of the stent body is 60° to 150°
  • the number of barbs in the row closer to the inflow channel of the stent body is smaller than that in the other row.
  • the barb structure includes two rows of barbs.
  • the two rows of barbs are a first row of barbs and a second row of barbs.
  • the first row of barbs is smaller than the second row of barbs.
  • the barbs are closer to the inflow channel, the first row of barbs are used to snap into the middle part of the native valve leaflet, and the second row of barbs are used to snap into the edge part of the native valve leaflet.
  • the number of barbs in the first row is smaller than the number of barbs in the second row.
  • the barb structure is integrally formed with the stent body.
  • the present application also provides a valve prosthesis, which includes the valve stent as described above.
  • the valve stent includes a stent body and a barb structure; the stent body is divided along its own circumferential direction into at least an anterior leaflet region, a posterior leaflet region, and a valve leaflet. Connection area; the barb structure includes at least two rows of barbs, the barbs are arranged along the circumference of the stent body, and the density of the barbs provided in the leaflet connection area is smaller than the barbs in the front leaflet area. The density of spines is not greater than the density of barbs in the posterior leaf area.
  • the barbs can be made to conform to the physiological anatomical area of the native valve leaflets, so that the degree of damage caused by the barbs to the native valve leaflets and their surrounding tissues is reduced, and the problem of the damage caused by the barbs to the native valve leaflets and their surrounding tissues after the valve stent is implanted is solved. Serious damage problem.
  • Figure 1 is a schematic diagram of the division of each region of the valve stent provided by an embodiment of the present application.
  • Figure 2 is a schematic diagram of a valve stent provided by an embodiment of the present application.
  • Figure 3 is a schematic diagram of the valve stent provided by an embodiment of the present application from another angle.
  • Figure 4 is a top view of a valve stent provided by an embodiment of the present application.
  • 10-stent body 11-front leaflet area, 12-posterior leaflet area, 121-posterior leaflet rear area, 122-posterior leaflet middle area, 123-posterior leaflet front area, 13-valve leaflet anterior connection area, 14- Postleaf connection area;
  • first”, “second” and “third” may explicitly or implicitly include one or at least two of these features, and the terms “mounted”, “connected” and “connected” shall be Broadly understood, for example, it can be a fixed connection, a detachable connection, or an integral body; it can be a direct connection or an indirect connection through an intermediate medium; it can be an internal connection between two elements or an interaction between two elements. .
  • one element is disposed on another element, which usually only means that there is a connection, coupling, matching or transmission relationship between the two elements, and the relationship between the two elements may be direct or indirect through an intermediate element.
  • connection, coupling, cooperation or transmission and cannot be understood as indicating or implying the spatial positional relationship between the two elements, that is, one element can be in any position such as inside, outside, above, below or to one side of the other element, unless the content Also clearly stated.
  • the specific meanings of the above terms in this application can be understood according to specific circumstances. Additionally, in the following description, numerous specific details are given in order to provide a thorough understanding of the present application. However, it will be apparent to one skilled in the art that the present application may be practiced without one or more of these details. In other examples, some technical features that are well known in the art are not described in order to avoid confusion with the present application.
  • Embodiments of the present application provide a valve stent and a valve prosthesis.
  • the valve stent includes a stent body and a barb structure; the stent body is divided along its own circumferential direction into at least an anterior leaflet region, a posterior leaflet region, and a valve leaflet. Connection area; the barb structure includes at least two rows of barbs, the barbs are arranged along the circumference of the stent body, and the density of the barbs provided in the leaflet connection area is smaller than the barbs in the front leaflet area.
  • the density of spines is not greater than the density of barbs in the posterior leaf area.
  • the barbs can be made to conform to the physiological anatomical area of the native valve leaflets, so that the degree of damage caused by the barbs to the native valve leaflets and their surrounding tissues is reduced, and the problem of the damage caused by the barbs to the native valve leaflets and their surrounding tissues after the valve stent is implanted is solved. Serious damage problem.
  • valve stent can be applied to native valve leaflets such as mitral valve, tricuspid valve and aorta.
  • the valve stent includes: a stent body 10 and a barbed structure 20 .
  • the stent body 10 is divided along its circumferential direction into at least an anterior leaflet area 11, a posterior leaflet area 12 and a leaflet connection area.
  • the leaflet connection area at least includes a leaflet front connection area 13 and a leaflet rear connection area 14 .
  • the area division of the stent body 10 is set according to the type of implanted valve leaflets.
  • the valve stent needs to be implanted in the mitral valve, and the region of the stent body 10 is divided according to the mitral valve, that is, the stent body 10 is divided into anterior leaflets along its own circumferential direction. Area 11, posterior lobe area 12.
  • the specific division of the leaflet connection area is also divided according to the type of the leaflet.
  • the mitral valve has an anterolateral triangle and a posterolateral triangle
  • the leaflet connection area has an anterior connection area of the leaflet respectively.
  • Region 13 and leaflet posterior connection region 14 are used to match the anterolateral triangle and posterolateral triangle of the mitral valve.
  • the region of the stent body 10 is divided according to the region of the tricuspid valve, that is, the stent body 10 is divided into anterior leaflet regions along its own circumference. , posterior lobe area, septal lobe area.
  • the specific division of the leaflet connection area is also divided according to the type of the leaflet.
  • the valve leaflet connection area includes three areas, namely the connection area between the anterior leaflet area and the posterior leaflet area, and the connection area between the anterior leaflet area and the septal leaflet area. area, the connecting area between the posterior lobe area and the septal lobe area. These three areas respectively correspond to the connection parts between the three leaflets of the tricuspid valve, so that the stent body 10 and the tricuspid valve have a high degree of matching.
  • the barb structure 20 includes at least two rows of barbs 21.
  • the barbs 21 are arranged along the circumference of the stent body 10 so that the barbs 21 can penetrate into the native valve leaflets and thereby fix the stent body 10 to the native valve leaflets.
  • Leaf position It should be understood that the distribution position of the barbs 21 corresponds to the native valve leaflets of the heart, and the division of the regions is based on anatomical positions.
  • the density of the barbs 21 provided in the leaflet connection area for example, the barbs 21 provided in the leaflet front connection area 13 and the valve leaflet rear connection area 14 is smaller than the barbs in the front leaflet area 11 21, and is no greater than the density of barbs 21 in the posterior leaf area 12.
  • Such arrangement can make the barb 21 conform to the physiological anatomical area of the native valve leaflet, so that the degree of damage to the connecting area of the anterior and posterior leaflets of the native valve leaflet by the barb 21 is smaller than the degree of damage to the anterior leaflet and posterior leaflet of the native valve leaflet by the barb 21. , it can also reduce the damage of the barbs 21 to the surrounding tissue, thereby ensuring the normal opening and closing of the artificial valve leaflets, and controlling the original valve leaflets without affecting the blood flow, effectively reducing the damage of the barbs 21 to the heart tissue, that is, using more Fewer barbs 21 achieve better therapeutic effect.
  • the density of the barbs 21 in the connecting area of the anterior and posterior leaflets is relatively reduced, so that the number of barbs 21 is relatively reduced, which is beneficial to reducing the volume of the valve stent in the delivery tube, thereby reducing the size of the delivery tube and reducing the need for valve stent implantation Damage to blood vessels, atrial septum or myocardium during the process.
  • This article takes the mitral valve as an example for description. That is, in this embodiment, the leaflets described below can all represent the mitral valve leaflets.
  • the rear leaf area 12 includes a rear leaf rear area 121, a rear leaf middle area 122 and a rear leaf front area 123, and the barbs 21 are provided in the rear leaf middle area 122.
  • the density is smaller than the density of the barbs 21 in the posterior region 121 and/or the anterior region 123 of the posterior leaflet, which can reduce the impact of the barbs 21 in the middle region 122 of the posterior leaflet on the posterior leaflet and the native valve leaflet.
  • the damage to the posterior atrial wall further reduces the damage of the barb 21 to the heart tissue.
  • the density of the barbs 21 in the middle region 122 of the posterior leaf is smaller than the density of the barbs 21 in the posterior region 121 and the front region 123 of the posterior leaf.
  • the density of the barbs 21 provided in the front connection area 13 of the leaflets, the rear connection area 14 of the leaflets and/or the middle area 122 of the posterior leaflets is smaller than that in the front leaflet area 11 and the rear side of the posterior leaflets.
  • the density of barbs 21 in the region 121 and the anterior region 123 of the posterior leaflet can thereby reduce the damage caused by the barbs 21 to the leaflet front connection region 13, the leaflet posterior connection region 14 and/or the posterior leaflet middle region 122 .
  • the leaflet connection area at least includes a leaflet front connection area 13 and a leaflet rear connection area 14, the leaflet front connection area 13, the leaflet rear connection area 14 and the middle area of the rear leaflet.
  • At least one of 122 does not have the barbed structure, so that when the valve stent is implanted at the native valve leaflet position, the tissues in these areas will not be damaged.
  • barbs 21 are not provided in the leaflet front connection area 13 and the valve leaflet rear connection area 14, which can reduce the damage of the barbs 21 to the myocardium.
  • No barbs 21 are provided in the middle region 122 of the posterior leaflet, which can reduce the damage caused by the barbs 21 to the posterior leaflet and the posterior atrial wall of the native valve leaflet.
  • the leaflet connection area at least includes a leaflet front connection area 13 and a leaflet rear connection area 14 , and the leaflet front connection area 13 and/or the leaflet rear connection area 14
  • the angular distribution along the circumferential direction of the stent body 10 is greater than 0° and less than or equal to 90°, and the angular distribution of the anterior leaf region 11 along the circumferential direction of the stent body 10 is 60° to 180°.
  • the angular distribution of the leaflet front connection area 13 and the leaflet rear connection area 14 along the circumferential direction of the stent body 10 is 30° respectively.
  • the angle distribution of the front leaf area 11 along the circumferential direction of the stent body 10 is 110°.
  • the angle distribution of the posterior leaf area 12 along the circumferential direction of the stent body 10 is 190°.
  • the angle distribution of each area can also be set according to the actual situation, and this article will not go into details here.
  • the rear leaf area 12 includes a rear leaf rear area 121, a rear leaf middle area 122 and a rear leaf front area 123.
  • the rear leaf middle area 122 is angularly distributed along the circumferential direction of the stent body 10. is 0° to 90°, and the angle distribution of the rear leaf area 121 and/or the rear leaf front area 123 along the circumferential direction of the stent body 10 is 60° to 150°.
  • the angular distribution of the rear area 121 of the rear leaf is 70°
  • the angular distribution of the middle area 122 of the rear leaf is 30°
  • the angular distribution of the front area 123 of the rear leaf is 90°. °.
  • those skilled in the art can also make adaptive adjustments. Such arrangement can make different areas of the stent body 10 of the valve stent fit better with the myocardium and native valve leaflets, so that the barbs 21 provided in different areas of the stent body 10 can be more closely aligned with the heart tissue according to anatomical regional divisions. Better targeted connections.
  • the barb structure 20 may be two rows of barbs 21, or may be three rows or four rows of barbs 21. In any two rows of barbs 21 in the at least two rows of barbs, that is, in different rows Among the barbs 21 , a row of barbs 21 closer to the inflow channel A of the stent body 10 has a smaller number of barbs 21 than other rows of barbs 21 .
  • each row of barbs 21 respectively corresponds to a certain radial tissue part of the bent native valve leaflet.
  • the barbs 21 are stuck on the native valve leaflets, since the edges of the native valve leaflets are not easy to fix, more barbs 21 are needed for fixation. In non-edge areas, it is relatively easy to fix and fewer barbs are needed. 21 for fixation. In this way, the minimum number of barbs 21 can be used for the most stable fixation, thereby reducing additional damage to the heart tissue caused by the barbs 21.
  • the barb structure 20 includes two rows of barbs 21 , and the two rows of barbs 21 are respectively a first row of barbs 211 and a second row of barbs 212 .
  • the first row of barbs 211 is closer to the inflow channel A than the second row of barbs 212 .
  • the first row of barbs 211 is used to snap into the middle part of the native valve leaflet.
  • the middle part refers to the portion between the annulus of the native valve leaflet and the edge of the native valve leaflet along the axial direction of the stent body 10 . More specifically, the middle portion may represent the middle position of a line connecting the annular end of the native valve leaflet to the edge end of the native valve leaflet.
  • the first row of barbs 211 are stuck under the valve annulus, thereby fixing the native valve leaflets, so that the valve prosthesis can open and close normally during cardiac systole and diastole.
  • the second row of barbs 212 is used to snap into the edge of the native valve leaflet, and mainly controls the edge of the native valve leaflet, so that the native valve leaflet does not hinder the blood flow from the aorta during systole.
  • the edge part may represent the edge end of the native valve leaflet.
  • the number of the first row of barbs 211 can be smaller than the number of the second row of barbs 212, so that the pair of barbs 21 Damage to cardiac tissue is minimized.
  • the barb structure 20 and the stent body 10 are integrally formed.
  • the barb structure 20 can be formed by an integral forming processing method, specifically by an integral cutting method.
  • the barb structure 20 and the stent body 10 can also be fixedly connected in other ways, which will not be described again here.
  • the valve stent is made of implantable metal material, such as titanium alloy or cobalt-chromium alloy. Or it can also be made of polymer material, and the polymer material can be polylactic acid (PLA). Of course, the valve stent can also be made of other implantable materials.
  • implantable metal material such as titanium alloy or cobalt-chromium alloy.
  • polymer material can be polylactic acid (PLA).
  • PLA polylactic acid
  • the valve stent can also be made of other implantable materials.
  • valve prosthesis which includes the valve stent as described above.
  • the valve prosthesis is, for example, an artificial heart valve prosthesis, used for mitral valve or tricuspid valve, etc.
  • the valve prosthesis has the beneficial effects brought by the valve stent, which will not be described in detail here.
  • the valve stent includes a stent body and a barb structure; the stent body is divided along its own circumferential direction into at least an anterior leaflet area and a posterior leaflet area.
  • the barbs can be made to conform to the physiological anatomical area of the native valve leaflets, so that the degree of damage caused by the barbs to the native valve leaflets and their surrounding tissues is reduced, and the problem of the damage caused by the barbs to the native valve leaflets and their surrounding tissues after the valve stent is implanted is solved. Serious damage problem.

Abstract

A valve stent and a valve prosthesis. The valve stent comprises: a stent body (10) and a barb structure (20). The stent body (10), in its own circumferential direction, is at least divided into an anterior leaflet region (11), a posterior leaflet region (12), and valve leaflet connection regions (13, 14). The barb structure (20) comprises at least two rows of barbs (21). The barbs (21) are arranged in the circumferential direction of the stent body (10). The density of the barbs (21) arranged in the valve leaflet connection regions (13, 14) is less than the density of the barbs (21) in the anterior leaflet region (11) and is not greater than the density of the barbs (21) in the posterior leaflet region (12). In this way, the barbs (21) can conform to the physiologically anatomical region of native valve leaflets, so that the degree of damage to the native valve leaflets and surrounding tissues thereof caused by the barbs (21) is reduced, which solves the problem of serious damage to the native valve leaflets and the surrounding tissues thereof caused by the barbs (21) after the valve stent is implanted.

Description

瓣膜支架以及瓣膜假体Valve stents and valve prostheses 技术领域Technical field
本申请涉及医疗器械技术领域,特别涉及一种瓣膜支架以及瓣膜假体。The present application relates to the technical field of medical devices, and in particular to a valve stent and a valve prosthesis.
背景技术Background technique
随着社会经济的发展和人口老龄化的加重,老年性瓣膜病以及冠心病、心肌梗死后引起的瓣膜病变也越来越常见。研究表明,超过13.3%的75岁以上的老年人患有不同程度的心脏瓣膜疾病。心脏瓣膜疾病已逐渐成为威胁人类健康的重要原因之一,二尖瓣、三尖瓣、主动脉瓣疾病等是临床上比较常见的心脏瓣膜疾病。以二尖瓣为例,人体的心脏分为左心房、左心室和右心房、右心室四个心腔,两个心房分别和两个心室相连,两个心室和两个大动脉相连。二尖瓣生长在左心房和左心室之间,由瓣叶、瓣环、腱索、和乳头肌组成,起到单向阀门的作用,保证血流仅允许从左心房向左心室单方向运动。二尖瓣反流是最为常见的二尖瓣疾病之一,其是指当在心室收缩阶段期间,二尖瓣膜未能恰当地闭合,血液从左心室反向流入左心房。使用二尖瓣置换装置,是常见的治疗手段之一。二尖瓣瓣膜置换装置是一种可植入式假体装置,由人工瓣叶、裙边、支架三部分组成。支架的功能是将人工瓣叶固定在原生二尖瓣瓣叶的位置,使人工瓣叶能正常工作并固定原生二尖瓣瓣叶,保证血流在左心内正常流动。With the development of social economy and the aging of the population, senile valvular disease and valvular lesions caused by coronary heart disease and myocardial infarction are becoming more and more common. Research shows that more than 13.3% of people over the age of 75 suffer from varying degrees of heart valve disease. Heart valve disease has gradually become one of the important causes threatening human health. Mitral valve, tricuspid valve, and aortic valve diseases are relatively common clinical heart valve diseases. Taking the mitral valve as an example, the human heart is divided into four chambers: left atrium, left ventricle, right atrium, and right ventricle. The two atria are connected to the two ventricles respectively, and the two ventricles are connected to the two aorta. The mitral valve grows between the left atrium and the left ventricle and is composed of leaflets, annulus, chordae tendineae, and papillary muscles. It functions as a one-way valve to ensure that blood flow is only allowed to move in one direction from the left atrium to the left ventricle. . Mitral regurgitation, one of the most common mitral valve diseases, occurs when the mitral valve fails to close properly during the ventricular systole phase and blood flows backward from the left ventricle into the left atrium. The use of mitral valve replacement devices is one of the common treatments. The mitral valve replacement device is an implantable prosthetic device, which consists of three parts: artificial valve leaflets, skirt, and stent. The function of the stent is to fix the artificial valve leaflets in the position of the native mitral valve leaflets, so that the artificial valve leaflets can work normally and fix the native mitral valve leaflets to ensure normal blood flow in the left heart.
但是,在现有的瓣膜假体中,瓣膜假体的瓣膜支架固定原生瓣叶的方式有很多,例如利用倒刺固定瓣膜支架和原生瓣叶,但倒刺通常采用均匀分布设计,没有顺应心脏原生组织的生理结构。同时过多的倒刺会造成对原生瓣叶以及其周围组织,例如对主动脉瓣、心肌、腱索等造成损伤,不利于治疗效果,甚至引发并发症。However, in existing valve prostheses, there are many ways for the valve stent of the valve prosthesis to fix the native valve leaflets, such as using barbs to fix the valve stent and the native valve leaflets. However, the barbs are usually designed to be evenly distributed and do not conform to the heart. Physiological structure of native tissue. At the same time, too many barbs will cause damage to the native valve leaflets and surrounding tissues, such as the aortic valve, myocardium, chordae tendineae, etc., which is detrimental to the treatment effect and may even cause complications.
因此,开发出一种能够减小倒刺对原生瓣叶以及其周围组织损伤的瓣膜支架以及瓣膜假体,是亟待解决的问题。Therefore, it is an urgent problem to develop a valve stent and valve prosthesis that can reduce the damage caused by barbs to the native valve leaflets and surrounding tissues.
发明内容Contents of the invention
本申请的目的在于提供一种瓣膜支架以及瓣膜假体,以解决目前在瓣膜支架中,倒刺对原生瓣叶以及其周围组织损伤严重的问题。The purpose of this application is to provide a valve stent and a valve prosthesis to solve the current problem in the valve stent that the barbs seriously damage the native valve leaflets and surrounding tissues.
为解决上述技术问题,本申请提供一种瓣膜支架,包括支架主体以及倒刺结构;所述支架主体沿其自身的周向至少划分为前叶区域、后叶区域以及瓣叶连接区域;所述倒刺结构包括至少两排倒刺,每排所述倒刺沿所述支架主体的周向设置,设置于所述瓣叶连接区域的倒刺的密度小于所述前叶区域的倒刺的密度、且不大于所述后叶区域的倒刺的密度。In order to solve the above technical problems, the present application provides a valve stent, which includes a stent body and a barb structure; the stent body is divided along its own circumferential direction into at least an anterior leaflet region, a posterior leaflet region, and a valve leaflet connection region; The barb structure includes at least two rows of barbs, each row of barbs is arranged along the circumference of the stent body, and the density of barbs provided in the leaflet connection area is smaller than the density of barbs in the front leaflet area. , and not greater than the density of barbs in the posterior leaf area.
可选的,所述后叶区域包括后叶后侧区域、后叶中部区域以及后叶前侧区域,设置于所述后叶中部区域的倒刺的密度小于所述后叶后侧区域和/或所述后叶前侧区域的倒刺的密度。Optionally, the rear leaf area includes a rear leaf area, a middle area of the rear leaf and a front area of the rear leaf, and the density of barbs provided in the middle area of the rear leaf is smaller than the rear area and/or the rear leaf. or the density of barbs in the anterior region of the posterior lobe.
可选的,所述瓣叶连接区域至少包括瓣叶前连接区域以及瓣叶后连接区域,所述瓣叶前连接区域、所述瓣叶后连接区域以及所述后叶中部区域中的至少一者不设置任何倒刺。Optionally, the leaflet connection area at least includes a front connection area and a rear connection area, and at least one of the front connection area, the rear connection area and the middle area of the rear leaflet. The operator does not set any barbs.
可选的,所述瓣叶连接区域至少包括瓣叶前连接区域以及瓣叶后连接区域,所述瓣叶前连接区域和/或所述瓣叶后连接区域沿所述支架主体的周向的角度分布为大于0°且小于等于90°,所述前叶区域沿所述支架主体的周向的角度分布为60°~180°。Optionally, the leaflet connection area at least includes a front connection area and a rear connection area, and the front connection area and/or the rear connection area are along the circumferential direction of the stent body. The angle distribution is greater than 0° and less than or equal to 90°, and the angle distribution of the front leaf region along the circumferential direction of the stent body is 60° to 180°.
可选的,所述后叶区域包括后叶后侧区域、后叶中部区域以及后叶前侧区域,所述后叶中部区域沿所述支架主体的周向的角度分布为0°~90°,所述后叶后侧区域和/或所述后叶前侧区域沿所述支架主体的周向的角度分布为60°~150°Optionally, the rear leaf area includes a rear leaf area, a middle area of the rear leaf, and a front area of the rear leaf, and the angle distribution of the middle area of the rear leaf along the circumferential direction of the stent body is 0° to 90°. , the angle distribution of the rear area of the rear leaf and/or the front area of the rear leaf along the circumferential direction of the stent body is 60° to 150°
可选的,在所述至少两排倒刺中的任两排倒刺中,更加靠近所述支架主体的流入道的那排的倒刺的数量小于另一排。Optionally, in any two rows of barbs among the at least two rows of barbs, the number of barbs in the row closer to the inflow channel of the stent body is smaller than that in the other row.
可选的,所述倒刺结构包括两排倒刺,两排所述倒刺分别为第一排倒刺以及第二排倒刺,所述第一排倒刺相比于所述第二排倒刺更靠近所述流入道,所述第一排倒刺用于卡入原生瓣叶的中间部位,所述第二排倒刺用于卡入所述原生瓣叶的边缘部位。Optionally, the barb structure includes two rows of barbs. The two rows of barbs are a first row of barbs and a second row of barbs. The first row of barbs is smaller than the second row of barbs. The barbs are closer to the inflow channel, the first row of barbs are used to snap into the middle part of the native valve leaflet, and the second row of barbs are used to snap into the edge part of the native valve leaflet.
可选的,所述第一排倒刺的数量小于所述第二排倒刺的数量。Optionally, the number of barbs in the first row is smaller than the number of barbs in the second row.
可选的,所述倒刺结构与所述支架主体一体成型。Optionally, the barb structure is integrally formed with the stent body.
为解决上述技术问题,本申请还提供一种瓣膜假体,所述瓣膜假体包括如上所述的瓣膜支架。In order to solve the above technical problems, the present application also provides a valve prosthesis, which includes the valve stent as described above.
在本申请提供的一种瓣膜支架以及瓣膜假体中,所述瓣膜支架包括支架主体以及倒刺结构;所述支架主体沿其自身的周向至少划分为前叶区域、后叶区域以及瓣叶连接区域;所述倒刺结构包括至少两排倒刺,所述倒刺沿所述支架主体的周向设置,设置于所述瓣叶连接区域的倒刺的密度小于所述前叶区域的倒刺的密度、且不大于所述后叶区域的倒刺的密度。如此,可以使得倒刺顺应原生瓣叶的生理解剖区域,使得倒刺对原生瓣叶以及其周围组织的损伤的程度减小,解决了植入瓣膜支架后倒刺对原生瓣叶以及其周围组织损伤严重的问题。In the valve stent and valve prosthesis provided by this application, the valve stent includes a stent body and a barb structure; the stent body is divided along its own circumferential direction into at least an anterior leaflet region, a posterior leaflet region, and a valve leaflet. Connection area; the barb structure includes at least two rows of barbs, the barbs are arranged along the circumference of the stent body, and the density of the barbs provided in the leaflet connection area is smaller than the barbs in the front leaflet area. The density of spines is not greater than the density of barbs in the posterior leaf area. In this way, the barbs can be made to conform to the physiological anatomical area of the native valve leaflets, so that the degree of damage caused by the barbs to the native valve leaflets and their surrounding tissues is reduced, and the problem of the damage caused by the barbs to the native valve leaflets and their surrounding tissues after the valve stent is implanted is solved. Serious damage problem.
附图说明Description of the drawings
本领域的普通技术人员将会理解,提供的附图用于更好地理解本申请,而不对本申请的范围构成任何限定。其中:Those of ordinary skill in the art will understand that the drawings are provided for a better understanding of the present application and do not constitute any limitation on the scope of the present application. in:
图1为本申请一实施例提供的瓣膜支架的各区域的划分的示意图。Figure 1 is a schematic diagram of the division of each region of the valve stent provided by an embodiment of the present application.
图2为本申请一实施例提供的瓣膜支架的示意图。Figure 2 is a schematic diagram of a valve stent provided by an embodiment of the present application.
图3为本申请一实施例提供的瓣膜支架的另一角度的示意图。Figure 3 is a schematic diagram of the valve stent provided by an embodiment of the present application from another angle.
图4为本申请一实施例提供的瓣膜支架的俯视图。Figure 4 is a top view of a valve stent provided by an embodiment of the present application.
附图中:In the attached picture:
A-流入道,B-流出道;A-inflow tract, B-outflow tract;
10-支架主体,11-前叶区域,12-后叶区域,121-后叶后侧区域,122-后叶中部区域,123-后叶前侧区域,13-瓣叶前连接区域,14-瓣叶后连接区域;10-stent body, 11-front leaflet area, 12-posterior leaflet area, 121-posterior leaflet rear area, 122-posterior leaflet middle area, 123-posterior leaflet front area, 13-valve leaflet anterior connection area, 14- Postleaf connection area;
20-倒刺结构,21-倒刺,211-第一排倒刺,212-第二排倒刺。20-Barb structure, 21-Barb, 211-First row of barbs, 212-Second row of barbs.
具体实施方式Detailed ways
为使本申请的目的、优点和特征更加清楚,以下结合附图和具体实施例对本申请作进一步详细说明。需说明的是,附图均采用非常简化的形式且未 按比例绘制,仅用以方便、明晰地辅助说明本申请实施例的目的。此外,附图所展示的结构往往是实际结构的一部分。特别的,各附图需要展示的侧重点不同,有时会采用不同的比例。In order to make the purpose, advantages and features of the present application clearer, the present application will be further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the accompanying drawings are in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist the purpose of explaining the embodiments of the present application. In addition, the structures shown in the drawings are often part of the actual structure. In particular, each drawing needs to display different emphasis, and sometimes uses different proportions.
如在本说明书中所使用的,单数形式“一”、“一个”以及“该”包括复数对象,除非内容另外明确指出外。如在本说明书中所使用的,术语“或”通常是以包括“和/或”的含义而进行使用的,除非内容另外明确指出外。术语“若干”通常是以包括“至少一个”的含义而进行使用的,术语“至少两个”通常是以包括“两个或两个以上”的含义而进行使用的,此外,术语“第一”、“第二”、“第三”仅用于描述目的,而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此,限定有“第一”、“第二”、“第三”的特征可以明示或者隐含地包括一个或者至少两个该特征,术语“安装”、“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或成一体;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通或两个元件的相互作用关系。此外,如在本申请中所使用的,一元件设置于另一元件,通常仅表示两元件之间存在连接、耦合、配合或传动关系,且两元件之间可以是直接的或通过中间元件间接的连接、耦合、配合或传动,而不能理解为指示或暗示两元件之间的空间位置关系,即一元件可以在另一元件的内部、外部、上方、下方或一侧等任意方位,除非内容另外明确指出外。对于本领域的普通技术人员而言,可以根据具体情况理解上述术语在本申请中的具体含义。另外,在下文的描述中,给出了大量具体的细节以便提供对本申请更为彻底的理解。然而,对于本领域技术人员而言显而易见的是,本申请可以无需一个或多个这些细节而得以实施。在其他的例子中,为了避免与本申请发生混淆,对于本领域公知的一些技术特征未进行描述。As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally used in its sense including "and/or" unless the content clearly dictates otherwise. The term "several" is generally used in the sense of including "at least one", and the term "at least two" is generally used in the sense of including "two or more". In addition, the term "first ”, “second” and “third” are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the quantity of indicated technical features. Therefore, the features defined as "first", "second" and "third" may explicitly or implicitly include one or at least two of these features, and the terms "mounted", "connected" and "connected" shall be Broadly understood, for example, it can be a fixed connection, a detachable connection, or an integral body; it can be a direct connection or an indirect connection through an intermediate medium; it can be an internal connection between two elements or an interaction between two elements. . In addition, as used in this application, one element is disposed on another element, which usually only means that there is a connection, coupling, matching or transmission relationship between the two elements, and the relationship between the two elements may be direct or indirect through an intermediate element. connection, coupling, cooperation or transmission, and cannot be understood as indicating or implying the spatial positional relationship between the two elements, that is, one element can be in any position such as inside, outside, above, below or to one side of the other element, unless the content Also clearly stated. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to specific circumstances. Additionally, in the following description, numerous specific details are given in order to provide a thorough understanding of the present application. However, it will be apparent to one skilled in the art that the present application may be practiced without one or more of these details. In other examples, some technical features that are well known in the art are not described in order to avoid confusion with the present application.
本申请实施例提供了一种瓣膜支架以及瓣膜假体,所述瓣膜支架包括支架主体以及倒刺结构;所述支架主体沿其自身的周向至少划分为前叶区域、后叶区域以及瓣叶连接区域;所述倒刺结构包括至少两排倒刺,所述倒刺沿所述支架主体的周向设置,设置于所述瓣叶连接区域的倒刺的密度小于所述前叶区域的倒刺的密度、且不大于所述后叶区域的倒刺的密度。如此,可以 使得倒刺顺应原生瓣叶的生理解剖区域,使得倒刺对原生瓣叶以及其周围组织的损伤的程度减小,解决了植入瓣膜支架后倒刺对原生瓣叶以及其周围组织损伤严重的问题。Embodiments of the present application provide a valve stent and a valve prosthesis. The valve stent includes a stent body and a barb structure; the stent body is divided along its own circumferential direction into at least an anterior leaflet region, a posterior leaflet region, and a valve leaflet. Connection area; the barb structure includes at least two rows of barbs, the barbs are arranged along the circumference of the stent body, and the density of the barbs provided in the leaflet connection area is smaller than the barbs in the front leaflet area. The density of spines is not greater than the density of barbs in the posterior leaf area. In this way, the barbs can be made to conform to the physiological anatomical area of the native valve leaflets, so that the degree of damage caused by the barbs to the native valve leaflets and their surrounding tissues is reduced, and the problem of the damage caused by the barbs to the native valve leaflets and their surrounding tissues after the valve stent is implanted is solved. Serious damage problem.
以下参考附图进行描述。Description will be made below with reference to the drawings.
请参考图1至图4,本实施例提供一种瓣膜支架。所述瓣膜支架可以应用于二尖瓣、三尖瓣以及主动脉等原生瓣叶。所述瓣膜支架包括:支架主体10以及倒刺结构20。Please refer to Figures 1 to 4. This embodiment provides a valve stent. The valve stent can be applied to native valve leaflets such as mitral valve, tricuspid valve and aorta. The valve stent includes: a stent body 10 and a barbed structure 20 .
所述支架主体10沿其自身的周向至少划分为前叶区域11、后叶区域12以及瓣叶连接区域。优选的,根据所述支架主体10的周向的划分,所述瓣叶连接区域至少包括瓣叶前连接区域13以及瓣叶后连接区域14。需理解,所述支架主体10的区域划分是依据植入瓣叶的类型进行设置。例如,在本实施例中,所述瓣膜支架需要植入二尖瓣瓣膜中,所述支架主体10的区域划分依据二尖瓣进行划分,即支架主体10沿其自身的周向划分为前叶区域11、后叶区域12。其中,瓣叶连接区域的具体划分也依据瓣叶的类型进行划分,例如,在本实施例中,二尖瓣瓣膜具有前外侧三角以及后外侧三角,瓣叶连接区域则分别具有瓣叶前连接区域13以及瓣叶后连接区域14,用以匹配二尖瓣瓣膜的前外侧三角以及后外侧三角。在其他实施例中,当瓣膜支架需要植入三尖瓣瓣膜时,所述支架主体10的区域划分依据三尖瓣的区域进行划分,即支架主体10沿其自身的周向划分为前叶区域、后叶区域、隔叶区域。其中,瓣叶连接区域的具体划分也依据瓣叶的类型进行划分,例如,瓣叶连接区域包括三个区域,即前叶区域与后叶区域的连接区域、前叶区域与隔叶区域的连接区域、后叶区域与隔叶区域的连接区域。这三个区域分别对应三尖瓣瓣膜的三个瓣叶之间的连接部,进而使得支架主体10与三尖瓣瓣膜具有较高的匹配度。The stent body 10 is divided along its circumferential direction into at least an anterior leaflet area 11, a posterior leaflet area 12 and a leaflet connection area. Preferably, according to the circumferential division of the stent body 10 , the leaflet connection area at least includes a leaflet front connection area 13 and a leaflet rear connection area 14 . It should be understood that the area division of the stent body 10 is set according to the type of implanted valve leaflets. For example, in this embodiment, the valve stent needs to be implanted in the mitral valve, and the region of the stent body 10 is divided according to the mitral valve, that is, the stent body 10 is divided into anterior leaflets along its own circumferential direction. Area 11, posterior lobe area 12. Among them, the specific division of the leaflet connection area is also divided according to the type of the leaflet. For example, in this embodiment, the mitral valve has an anterolateral triangle and a posterolateral triangle, and the leaflet connection area has an anterior connection area of the leaflet respectively. Region 13 and leaflet posterior connection region 14 are used to match the anterolateral triangle and posterolateral triangle of the mitral valve. In other embodiments, when the valve stent needs to be implanted into the tricuspid valve, the region of the stent body 10 is divided according to the region of the tricuspid valve, that is, the stent body 10 is divided into anterior leaflet regions along its own circumference. , posterior lobe area, septal lobe area. Among them, the specific division of the leaflet connection area is also divided according to the type of the leaflet. For example, the valve leaflet connection area includes three areas, namely the connection area between the anterior leaflet area and the posterior leaflet area, and the connection area between the anterior leaflet area and the septal leaflet area. area, the connecting area between the posterior lobe area and the septal lobe area. These three areas respectively correspond to the connection parts between the three leaflets of the tricuspid valve, so that the stent body 10 and the tricuspid valve have a high degree of matching.
所述倒刺结构20包括至少两排倒刺21,所述倒刺21沿所述支架主体10的周向设置,使得倒刺21能够刺入原生瓣叶,进而将支架主体10固定在原生瓣叶的位置。需理解,倒刺21的分布位置与心脏原生瓣叶对应,其区域的 划分是依据解剖学位置进行划分。设置于所述瓣叶连接区域的倒刺21,例如设置于所述瓣叶前连接区域13以及所述瓣叶后连接区域14的倒刺21的密度,小于所述前叶区域11的倒刺21的密度,且不大于所述后叶区域12的倒刺21的密度。如此设置,可以使得倒刺21顺应原生瓣叶的生理解剖区域,使得原生瓣叶的前后叶连接区域被倒刺21损伤的程度小于原生瓣叶的前叶、后叶被倒刺21损伤的程度,还可以减少倒刺21对其周围组织的损伤,进而保证人工瓣叶正常开闭,并控制原生瓣叶不影响血流的前提下,有效减少倒刺21对心脏组织的损伤,即用更少的倒刺21达到更优的治疗效果。并且,前后叶连接区域的倒刺21的密度相对的减小,使得倒刺21的数量相对减少,有利于减少瓣膜支架在输送管中的体积,从而降低输送管的尺寸,减少瓣膜支架植入过程中对血管、房间隔或者心肌的损伤。The barb structure 20 includes at least two rows of barbs 21. The barbs 21 are arranged along the circumference of the stent body 10 so that the barbs 21 can penetrate into the native valve leaflets and thereby fix the stent body 10 to the native valve leaflets. Leaf position. It should be understood that the distribution position of the barbs 21 corresponds to the native valve leaflets of the heart, and the division of the regions is based on anatomical positions. The density of the barbs 21 provided in the leaflet connection area, for example, the barbs 21 provided in the leaflet front connection area 13 and the valve leaflet rear connection area 14 is smaller than the barbs in the front leaflet area 11 21, and is no greater than the density of barbs 21 in the posterior leaf area 12. Such arrangement can make the barb 21 conform to the physiological anatomical area of the native valve leaflet, so that the degree of damage to the connecting area of the anterior and posterior leaflets of the native valve leaflet by the barb 21 is smaller than the degree of damage to the anterior leaflet and posterior leaflet of the native valve leaflet by the barb 21. , it can also reduce the damage of the barbs 21 to the surrounding tissue, thereby ensuring the normal opening and closing of the artificial valve leaflets, and controlling the original valve leaflets without affecting the blood flow, effectively reducing the damage of the barbs 21 to the heart tissue, that is, using more Fewer barbs 21 achieve better therapeutic effect. Moreover, the density of the barbs 21 in the connecting area of the anterior and posterior leaflets is relatively reduced, so that the number of barbs 21 is relatively reduced, which is beneficial to reducing the volume of the valve stent in the delivery tube, thereby reducing the size of the delivery tube and reducing the need for valve stent implantation Damage to blood vessels, atrial septum or myocardium during the process.
本文以二尖瓣为例进行描述,即本实施例中,下文所述瓣叶均可以表示二尖瓣瓣叶。This article takes the mitral valve as an example for description. That is, in this embodiment, the leaflets described below can all represent the mitral valve leaflets.
优选的,如图1所示,所述后叶区域12包括后叶后侧区域121、后叶中部区域122以及后叶前侧区域123,设置于所述后叶中部区域122的倒刺21的密度小于所述后叶后侧区域121和/或所述后叶前侧区域123的倒刺21的密度,可以减小所述后叶中部区域122的倒刺21对原生瓣叶的后叶和后心房壁的损伤,进一步减小了倒刺21对心脏组织的损伤。较佳的,所述后叶中部区域122的倒刺21的密度均小于所述后叶后侧区域121以及后叶前侧区域123的倒刺21的密度。Preferably, as shown in Figure 1, the rear leaf area 12 includes a rear leaf rear area 121, a rear leaf middle area 122 and a rear leaf front area 123, and the barbs 21 are provided in the rear leaf middle area 122. The density is smaller than the density of the barbs 21 in the posterior region 121 and/or the anterior region 123 of the posterior leaflet, which can reduce the impact of the barbs 21 in the middle region 122 of the posterior leaflet on the posterior leaflet and the native valve leaflet. The damage to the posterior atrial wall further reduces the damage of the barb 21 to the heart tissue. Preferably, the density of the barbs 21 in the middle region 122 of the posterior leaf is smaller than the density of the barbs 21 in the posterior region 121 and the front region 123 of the posterior leaf.
进一步的,设置于所述瓣叶前连接区域13、所述瓣叶后连接区域14和/或所述后叶中部区域122的倒刺21的密度小于所述前叶区域11、后叶后侧区域121以及后叶前侧区域123的倒刺21的密度,进而减小倒刺21对瓣叶前连接区域13、所述瓣叶后连接区域14和/或所述后叶中部区域122的损伤。更进一步的,所述瓣叶连接区域至少包括瓣叶前连接区域13以及瓣叶后连接区域14,所述瓣叶前连接区域13、所述瓣叶后连接区域14以及所述后叶中部区域122中的至少一者不设置所述倒刺结构,进而瓣膜支架植入原生瓣叶位置时,不损伤这几个区域的组织。具体的,在瓣叶前连接区域13、所述瓣 叶后连接区域14不设置倒刺21,可以减少倒刺21对心肌的损伤。在后叶中部区域122不设置倒刺21,可以减少倒刺21对原生瓣叶的后叶和后心房壁的损伤。Furthermore, the density of the barbs 21 provided in the front connection area 13 of the leaflets, the rear connection area 14 of the leaflets and/or the middle area 122 of the posterior leaflets is smaller than that in the front leaflet area 11 and the rear side of the posterior leaflets. The density of barbs 21 in the region 121 and the anterior region 123 of the posterior leaflet can thereby reduce the damage caused by the barbs 21 to the leaflet front connection region 13, the leaflet posterior connection region 14 and/or the posterior leaflet middle region 122 . Furthermore, the leaflet connection area at least includes a leaflet front connection area 13 and a leaflet rear connection area 14, the leaflet front connection area 13, the leaflet rear connection area 14 and the middle area of the rear leaflet. At least one of 122 does not have the barbed structure, so that when the valve stent is implanted at the native valve leaflet position, the tissues in these areas will not be damaged. Specifically, barbs 21 are not provided in the leaflet front connection area 13 and the valve leaflet rear connection area 14, which can reduce the damage of the barbs 21 to the myocardium. No barbs 21 are provided in the middle region 122 of the posterior leaflet, which can reduce the damage caused by the barbs 21 to the posterior leaflet and the posterior atrial wall of the native valve leaflet.
优选的,如图1所示,所述瓣叶连接区域至少包括瓣叶前连接区域13以及瓣叶后连接区域14,所述瓣叶前连接区域13和/或所述瓣叶后连接区域14沿所述支架主体10的周向的角度分布为大于0°且小于等于90°,所述前叶区域11沿所述支架主体10的周向的角度分布为60°~180°。例如,所述瓣叶前连接区域13与瓣叶后连接区域14沿支架主体10的周向的角度分布分别为30°。所述前叶区域11沿支架主体10的周向的角度分布为110°。所述后叶区域12沿支架主体10的周向的角度分布为190°。当然,各个区域的角度分布还可以根据实际情况进行设置,本文在此不做赘述。更优选的,所述后叶区域12包括后叶后侧区域121、后叶中部区域122以及后叶前侧区域123,所述后叶中部区域122沿所述支架主体10的周向的角度分布为0°~90°,所述后叶后侧区域121和/或所述后叶前侧区域123沿所述支架主体10的周向的角度分布为60°~150°。例如,在本实施例中,所述后叶后侧区域121的角度分布为70°,所述后叶中部区域122的角度分布为30°,所述后叶前侧区域123的角度分布为90°。当然,在其他实施例中,本领域技术人员还可以进行适应性的调整。如此设置,可以使得瓣膜支架的支架主体10的不同区域与心肌以及原生瓣叶更加贴合,从而使得设置于支架主体10的不同区域的倒刺21能够依据解剖学的区域划分与心脏组织更够更好的靶向的连接。Preferably, as shown in FIG. 1 , the leaflet connection area at least includes a leaflet front connection area 13 and a leaflet rear connection area 14 , and the leaflet front connection area 13 and/or the leaflet rear connection area 14 The angular distribution along the circumferential direction of the stent body 10 is greater than 0° and less than or equal to 90°, and the angular distribution of the anterior leaf region 11 along the circumferential direction of the stent body 10 is 60° to 180°. For example, the angular distribution of the leaflet front connection area 13 and the leaflet rear connection area 14 along the circumferential direction of the stent body 10 is 30° respectively. The angle distribution of the front leaf area 11 along the circumferential direction of the stent body 10 is 110°. The angle distribution of the posterior leaf area 12 along the circumferential direction of the stent body 10 is 190°. Of course, the angle distribution of each area can also be set according to the actual situation, and this article will not go into details here. More preferably, the rear leaf area 12 includes a rear leaf rear area 121, a rear leaf middle area 122 and a rear leaf front area 123. The rear leaf middle area 122 is angularly distributed along the circumferential direction of the stent body 10. is 0° to 90°, and the angle distribution of the rear leaf area 121 and/or the rear leaf front area 123 along the circumferential direction of the stent body 10 is 60° to 150°. For example, in this embodiment, the angular distribution of the rear area 121 of the rear leaf is 70°, the angular distribution of the middle area 122 of the rear leaf is 30°, and the angular distribution of the front area 123 of the rear leaf is 90°. °. Of course, in other embodiments, those skilled in the art can also make adaptive adjustments. Such arrangement can make different areas of the stent body 10 of the valve stent fit better with the myocardium and native valve leaflets, so that the barbs 21 provided in different areas of the stent body 10 can be more closely aligned with the heart tissue according to anatomical regional divisions. Better targeted connections.
优选的,请参考图2,为保证瓣膜支架能使人工瓣叶固定在原生瓣叶的位置,使其正常开闭,又能控制原生瓣叶不会影响左室流出道血流,同时能减少心脏内组织的损伤。所述倒刺结构20可以是两排的倒刺21、还可以是三排或者四排的倒刺21,在所述至少两排倒刺中的任意两排倒刺21中,即在不同排的倒刺21中,其中更加靠近所述支架主体10的流入道A的一排倒刺21相比其他排的倒刺21,具有更少的倒刺21数量。这是因为,瓣膜支架植入原生瓣膜的位置,需使得原生瓣叶朝向流出道B的方向弯折。不同排的倒刺21沿支架主体10的轴向分排布设,每一排的倒刺21分别对应被弯折的原生瓣叶 的某一径向的组织部位。在倒刺21卡入原生瓣叶上时,由于原生瓣叶的边缘不容易固定,需要更多的倒刺21进行固定,在非边缘的区域则相对比较容易固定,可以需要更少的倒刺21进行固定。如此可以最少的倒刺21数量进行最稳固的固定,进而减少了倒刺21对心脏组织的额外的损伤。Preferably, please refer to Figure 2, in order to ensure that the valve stent can fix the artificial valve leaflets in the position of the native valve leaflets, allowing them to open and close normally, and control the native valve leaflets not to affect the left ventricular outflow tract blood flow, and at the same time reduce Damage to tissue within the heart. The barb structure 20 may be two rows of barbs 21, or may be three rows or four rows of barbs 21. In any two rows of barbs 21 in the at least two rows of barbs, that is, in different rows Among the barbs 21 , a row of barbs 21 closer to the inflow channel A of the stent body 10 has a smaller number of barbs 21 than other rows of barbs 21 . This is because the position of the valve stent implanted into the native valve needs to make the native valve leaflets bend toward the direction of the outflow tract B. Different rows of barbs 21 are arranged along the axial direction of the stent body 10, and each row of barbs 21 respectively corresponds to a certain radial tissue part of the bent native valve leaflet. When the barbs 21 are stuck on the native valve leaflets, since the edges of the native valve leaflets are not easy to fix, more barbs 21 are needed for fixation. In non-edge areas, it is relatively easy to fix and fewer barbs are needed. 21 for fixation. In this way, the minimum number of barbs 21 can be used for the most stable fixation, thereby reducing additional damage to the heart tissue caused by the barbs 21.
更优选的,如图2至图4所示,所述倒刺结构20包括两排倒刺21,两排所述倒刺21分别为第一排倒刺211以及第二排倒刺212,所述第一排倒刺211相比于所述第二排倒刺212更靠近所述流入道A。所述第一排倒刺211用于卡入原生瓣叶的中间部位。其中,所述中间部分表示沿支架主体10的轴向方向,原生瓣叶的瓣环至原生瓣叶的边缘之间的部位。更具体的,所述中间部分可以表示原生瓣叶的瓣环端至原生瓣叶的边缘端连线的中间位置。以二尖瓣为例,第一排倒刺211卡入瓣环下方,进而起到固定原生瓣叶的作用,使瓣膜假体在心脏收缩、舒张期能够正常开闭。所述第二排倒刺212与第一排倒刺211具有一定的距离,所述距离可以依据实际情况进行设置。所述第二排倒刺212用于卡入所述原生瓣叶的边缘部位,主要起到控制原生瓣叶的边缘,使原生瓣叶在心脏收缩期不阻碍血流从主动脉流出。其中,所述边缘部位可以表示原生瓣叶的边缘端部。More preferably, as shown in FIGS. 2 to 4 , the barb structure 20 includes two rows of barbs 21 , and the two rows of barbs 21 are respectively a first row of barbs 211 and a second row of barbs 212 . The first row of barbs 211 is closer to the inflow channel A than the second row of barbs 212 . The first row of barbs 211 is used to snap into the middle part of the native valve leaflet. Wherein, the middle part refers to the portion between the annulus of the native valve leaflet and the edge of the native valve leaflet along the axial direction of the stent body 10 . More specifically, the middle portion may represent the middle position of a line connecting the annular end of the native valve leaflet to the edge end of the native valve leaflet. Taking the mitral valve as an example, the first row of barbs 211 are stuck under the valve annulus, thereby fixing the native valve leaflets, so that the valve prosthesis can open and close normally during cardiac systole and diastole. There is a certain distance between the second row of barbs 212 and the first row of barbs 211, and the distance can be set according to actual conditions. The second row of barbs 212 is used to snap into the edge of the native valve leaflet, and mainly controls the edge of the native valve leaflet, so that the native valve leaflet does not hinder the blood flow from the aorta during systole. Wherein, the edge part may represent the edge end of the native valve leaflet.
进一步的,由于两排倒刺21的位置不同,起到的作用也不同,故所述第一排倒刺211的数量可以小于所述第二排倒刺212的数量,进而使得倒刺21对心脏组织的损伤降至最低。Furthermore, since the two rows of barbs 21 have different positions and play different roles, the number of the first row of barbs 211 can be smaller than the number of the second row of barbs 212, so that the pair of barbs 21 Damage to cardiac tissue is minimized.
优选的,所述倒刺结构20与所述支架主体10一体成型,具体可以采用一体成型的加工方法加工成型,具体可以采用一体切割的方式。当然,在其他实施例中,所述倒刺结构20与所述支架主体10还可以是固定连接的其他的连接方式,本文在此不再赘述。Preferably, the barb structure 20 and the stent body 10 are integrally formed. Specifically, the barb structure 20 can be formed by an integral forming processing method, specifically by an integral cutting method. Of course, in other embodiments, the barb structure 20 and the stent body 10 can also be fixedly connected in other ways, which will not be described again here.
优选的,所述瓣膜支架采用可植入的金属材料制成,例如采用钛合金、钴铬合金。或者还可以采用高分子材料制成,所述高分子材料可以是聚乳酸(PLA)。当然,所述瓣膜支架还可以采用其他的可植入的材料。Preferably, the valve stent is made of implantable metal material, such as titanium alloy or cobalt-chromium alloy. Or it can also be made of polymer material, and the polymer material can be polylactic acid (PLA). Of course, the valve stent can also be made of other implantable materials.
本实施例还提供一种瓣膜假体,所述瓣膜假体包括如上所述的瓣膜支架。所述瓣膜假体例如是人工心脏瓣膜假体,用于二尖瓣或三尖瓣等。所述瓣膜 假体具备瓣膜支架所带来的有益效果,本文在此不再赘述。所述瓣膜假体的其他的结构部件可参考现有技术,本文在此不再描述。This embodiment also provides a valve prosthesis, which includes the valve stent as described above. The valve prosthesis is, for example, an artificial heart valve prosthesis, used for mitral valve or tricuspid valve, etc. The valve prosthesis has the beneficial effects brought by the valve stent, which will not be described in detail here. For other structural components of the valve prosthesis, reference can be made to the prior art and will not be described here.
综上所述,在本申请提供的一种瓣膜支架以及瓣膜假体中,所述瓣膜支架包括支架主体以及倒刺结构;所述支架主体沿其自身的周向至少划分为前叶区域、后叶区域以及瓣叶连接区域;所述倒刺结构包括至少两排倒刺,所述倒刺沿所述支架主体的周向设置,设置于所述瓣叶连接区域的倒刺的密度小于所述前叶区域的倒刺的密度、且不大于所述后叶区域的倒刺的密度。如此,可以使得倒刺顺应原生瓣叶的生理解剖区域,使得倒刺对原生瓣叶以及其周围组织的损伤的程度减小,解决了植入瓣膜支架后倒刺对原生瓣叶以及其周围组织损伤严重的问题。To sum up, in the valve stent and valve prosthesis provided by this application, the valve stent includes a stent body and a barb structure; the stent body is divided along its own circumferential direction into at least an anterior leaflet area and a posterior leaflet area. The leaf area and the leaflet connection area; the barb structure includes at least two rows of barbs, the barbs are arranged along the circumferential direction of the stent body, and the density of the barbs provided in the leaflet connection area is smaller than the The density of barbs in the front leaf region is not greater than the density of barbs in the posterior leaf region. In this way, the barbs can be made to conform to the physiological anatomical area of the native valve leaflets, so that the degree of damage caused by the barbs to the native valve leaflets and their surrounding tissues is reduced, and the problem of the damage caused by the barbs to the native valve leaflets and their surrounding tissues after the valve stent is implanted is solved. Serious damage problem.
此外还应该认识到,虽然本申请已以较佳实施例披露如上,然而上述实施例并非用以限定本申请。对于任何熟悉本领域的技术人员而言,在不脱离本申请技术方案范围情况下,都可利用上述揭示的技术内容对本申请技术方案作出许多可能的变动和修饰,或修改为等同变化的等效实施例。因此,凡是未脱离本申请技术方案的内容,依据本申请的技术实质对以上实施例所做的任何简单修改、等同变化及修饰,均仍属于本申请技术方案保护的范围。In addition, it should be recognized that although the present application has been disclosed above with preferred embodiments, the above embodiments are not intended to limit the present application. For any person familiar with the art, without departing from the scope of the technical solution of the present application, the technical content disclosed above can be used to make many possible changes and modifications to the technical solution of the present application, or modify it into equivalent changes. Example. Therefore, any simple modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present application that do not deviate from the content of the technical solution of the present application still fall within the scope of protection of the technical solution of the present application.

Claims (10)

  1. 一种瓣膜支架,其特征在于,包括:支架主体以及倒刺结构;A valve stent, characterized by including: a stent body and a barbed structure;
    所述支架主体沿其自身的周向至少划分为前叶区域、后叶区域以及瓣叶连接区域;The stent body is divided along its own circumferential direction into at least an anterior leaflet area, a posterior leaflet area and a leaflet connection area;
    所述倒刺结构包括至少两排倒刺,每排所述倒刺沿所述支架主体的周向设置,设置于所述瓣叶连接区域的倒刺的密度小于所述前叶区域的倒刺的密度、且不大于所述后叶区域的倒刺的密度。The barb structure includes at least two rows of barbs, each row of barbs is arranged along the circumference of the stent body, and the density of barbs provided in the leaflet connection area is smaller than the barbs in the front leaflet area. The density is no greater than the density of barbs in the posterior leaf area.
  2. 根据权利要求1所述的瓣膜支架,其特征在于,所述后叶区域包括后叶后侧区域、后叶中部区域以及后叶前侧区域,设置于所述后叶中部区域的倒刺的密度小于所述后叶后侧区域和/或所述后叶前侧区域的倒刺的密度。The valve stent according to claim 1, wherein the posterior leaflet region includes a posterior leaflet posterior region, a posterior leaflet middle region, and a posterior leaflet front region, and the density of barbs provided in the posterior leaflet middle region is The density of barbs is smaller than the density of the barbs in the posterior region of the posterior lobe and/or the anterior region of the posterior lobe.
  3. 根据权利要求2所述的瓣膜支架,其特征在于,所述瓣叶连接区域至少包括瓣叶前连接区域以及瓣叶后连接区域,所述瓣叶前连接区域、所述瓣叶后连接区域以及所述后叶中部区域中的至少一者不设置任何倒刺。The valve stent according to claim 2, wherein the valve leaflet connection area at least includes a valve leaflet front connection area and a valve leaflet rear connection area, and the valve leaflet front connection area, the valve leaflet rear connection area and At least one of the middle regions of the posterior leaves is not provided with any barbs.
  4. 根据权利要求1所述的瓣膜支架,其特征在于,所述瓣叶连接区域至少包括瓣叶前连接区域以及瓣叶后连接区域,所述瓣叶前连接区域和/或所述瓣叶后连接区域沿所述支架主体的周向的角度分布为大于0°且小于等于90°,所述前叶区域沿所述支架主体的周向的角度分布为60°~180°。The valve stent according to claim 1, wherein the valve leaflet connection area at least includes a valve leaflet front connection area and a valve leaflet rear connection area, and the valve leaflet front connection area and/or the valve leaflet rear connection area The angular distribution of the region along the circumferential direction of the stent body is greater than 0° and less than or equal to 90°, and the angular distribution of the anterior leaf region along the circumferential direction of the stent body is 60° to 180°.
  5. 根据权利要求4所述的瓣膜支架,其特征在于,所述后叶区域包括后叶后侧区域、后叶中部区域以及后叶前侧区域,所述后叶中部区域沿所述支架主体的周向的角度分布为0°~90°,所述后叶后侧区域和/或所述后叶前侧区域沿所述支架主体的周向的角度分布为60°~150°。The valve stent according to claim 4, wherein the posterior leaflet region includes a posterior leaflet posterior region, a posterior leaflet middle region, and a posterior leaflet front region, and the posterior leaflet middle region is along the circumference of the stent body. The angular distribution in the circumferential direction of the stent body is 0° to 90°, and the angular distribution of the rear area of the rear leaf and/or the front area of the rear leaf along the circumferential direction of the stent body is 60° to 150°.
  6. 根据权利要求1所述的瓣膜支架,其特征在于,在所述至少两排倒刺中的任意两排倒刺中,更加靠近所述支架主体的流入道的那排的倒刺的数量少于另一排。The valve stent according to claim 1, wherein in any two rows of barbs among the at least two rows of barbs, the number of barbs in the row closer to the inflow channel of the stent body is less than Another row.
  7. 根据权利要求6所述的瓣膜支架,其特征在于,所述倒刺结构包括两排倒刺,两排所述倒刺分别为第一排倒刺以及第二排倒刺,所述第一排倒刺相比于所述第二排倒刺更靠近所述流入道,所述第一排倒刺用于卡入原生瓣 叶的中间部位,所述第二排倒刺用于卡入所述原生瓣叶的边缘部位。The valve stent according to claim 6, wherein the barb structure includes two rows of barbs, and the two rows of barbs are a first row of barbs and a second row of barbs, and the first row of barbs The barbs are closer to the inflow channel than the second row of barbs, the first row of barbs are used to snap into the middle part of the native valve leaflets, and the second row of barbs are used to snap into the The edge of the native valve leaflet.
  8. 根据权利要求7所述的瓣膜支架,其特征在于,所述第一排倒刺的数量小于所述第二排倒刺的数量。The valve stent according to claim 7, wherein the number of barbs in the first row is less than the number of barbs in the second row.
  9. 根据权利要求1所述的瓣膜支架,其特征在于,所述倒刺结构与所述支架主体一体成型。The valve stent according to claim 1, wherein the barb structure is integrally formed with the stent body.
  10. 一种瓣膜假体,其特征在于,所述瓣膜假体包括根据权利要求1-9中任一项所述的瓣膜支架。A valve prosthesis, characterized in that the valve prosthesis includes the valve stent according to any one of claims 1-9.
PCT/CN2022/096676 2022-04-24 2022-06-01 Valve stent and valve prosthesis WO2023206710A1 (en)

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